cobas c 311 analyzer

Operator’s Manual
Software Version 01-01
 cobas c 311 analyzer

Document information

Revision history Manual version Software version Revision date Changes

1.0 01-01 November 2007

Language Order Number

English 0494 0172.018
French 0494 0172.080
German 0494 0172.001
Italian 0494 0172.050
Portuguese 0494 0172.046
Spanish 0494 0172.036

Edition notice Operator’s Manual for users of the cobas c 311 analyzer.
Every effort has been made to ensure that all the information contained in this
document is correct at the time of issue. However, Roche Diagnostics GmbH reserves
the right to make any changes necessary without notice as part of ongoing product
development.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Software updates may only be carried out by Roche service representatives.

Intended use The cobas c 311 analyzer is an automated, discrete clinical chemistry analyzer
intended for the in vitro quantitative/qualitative determination of analytes in body
fluids. It is important that the operator reads this manual thoroughly before using the
analyzer.

Copyright © 2007, Roche Diagnostics GmbH. All rights reserved.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS INTEGRA and LIFE NEEDS ANSWERS are trademarks
of Roche.
All other trademarks are the property of their respective owners.

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Instrument approvals The cobas c 311 analyzer meets the protection requirements laid down in IVD
Directive 98/79/EC. Furthermore, our instruments are manufactured and tested
according to the following international standards:
o IEC 61010-1: 2001
o IEC 61010-2-010: 2003
o IEC 61010-2-081: 2001
o IEC 61010-2-101: 2002
o UL 61010-1: 2001
o CAN/CSA C22.2 No. 61010-1-04
o EN 61326-2-6:2006
The Operator’s manual meets the requirements of European Standard EN 591.
Compliance is demonstrated by the following marks:

Complies with the IVD directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

US.
C ® US

Contact addresses

Manufacturer Hitachi High-Technologies Corporation

24-14. Nishi-shimbashi. 1-chome. Minato-ku
Tokyo. 105-8717 JAPAN

Authorized Representative Roche Diagnostics GmbH

Sandhofer Strasse 116
D-68305 Mannheim
Germany

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Table of contents

Document information 2 6 Daily operation

Contact addresses 3 Overview B-29
Table of contents 5 Starting the analyzer B-30
Preface 7 Preroutine operation B-40
Where to find information 7 Routine Operation B-56
Online Help system 8 Shutting down the analyzer B-71
Customer information 8
Conventions used in this manual 8 7 Orders and results
Overview B-77
Test Selection screen B-78
System description Part A Data Review screen B-88

1 General safety information 8 Reagents

Safety classifications A-5 Reagent concept B-97
Safety precautions A-6 cobas c packs B-101
Safety summary A-8 Handling of reagents B-103
Safety labels of the system A-13 Reagent screen overview B-106
Disposal of the analyzer A-19 Reagent Setting screen B-107
Reagent Status screen B-108
2 Description of the analyzer Reagent Overview button B-111
Overview A-23
Power switches A-27 9 Calibration
Control unit A-28 Calibration concept B-117
cobas® link A-31 Calibration Screen Overview B-122
Sampling area components A-36 Calibration Status screen B-122
Reagent area components A-43 Calibration Install screen B-131
Reaction disk area components A-48 Calibration Calibrator screen B-137
ISE area components A-58 System Overview screen B-139
Behind the front doors A-63
Rear view A-65 10 QC
QC concept B-143
3 Specifications QC Status screen B-146
System specifications A-69 QC Run Status screen B-150
Control unit A-71 QC Individual screen B-152
Analytical unit A-72 QC Cumulative screen B-160
Other specifications A-75 QC Control screen B-162
QC Install screen B-164
Programming auto QC measurements B-170
Operation Part B
11 Configuration
4 Safety information for operation Application B-173
System configuration B-191
5 Software basics Module Set B-202
General description of the user interface B-7 Calculated Tests B-204
Fixed areas B-8 Special Wash B-209
Main menus B-11 Report Format B-214
Software elements B-17 Saving system parameters B-217
Online Help system B-23 Restoring system parameters B-219
Shortcut keys B-24

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Maintenance Part C Revisions Part G

12 Safety information for maintenance

Notes Part H
13 General maintenance
Overview C-7
Maintenance items C-8
Maintenance pipes C-10
Maintenance types C-17
Maintenance report C-20
List of maintenance items C-21
List of maintenance checks C-24

14 Maintenance of the analyzer

Maintenance schedules C-27
Periodic replacement of parts C-39
Daily maintenance C-40
Weekly maintenance C-50
Monthly maintenance C-62
Every two months maintenance C-74
Quarterly maintenance C-79
Every six months maintenance C-93
As needed maintenance C-104

Troubleshooting Part D

15 Data alarms
Introduction D-7
Data alarm list D-8
Data alarms (ISE unit) D-9
Data alarms (photometric unit) D-17
Alarms for calibrations D-25
Data alarms for controls D-34
Data problems without alarm D-38
Rerun list D-41

16 Troubleshooting
General troubleshooting D-45
General instrument troubleshooting D-47
ISE troubleshooting D-51
Troubleshooting of the photometric unit D-54

Glossary Part E

Glossary E-3

Index Part F

Index F-3

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Preface

The cobas c 311 analyzer is an automated, software-controlled analyzer for clinical

chemistry analysis. It is designed for both quantitative and qualitative in vitro
determinations using a large variety of tests for analysis. The cobas c 311 analyzer
performs photometric assays and ion-selective electrode measurements and uses
serum/plasma, urine, CSF, and supernatant sample types.
This manual contains a detailed description of the cobas c 311 analyzer’s features and
general operational concepts, specification functions and use of controls, operating
techniques, emergency procedures, product labeling and maintenance procedures.

Observe the instructions of the Operator’s Manual for safe operation of the system
o If the system is used in a manner not specified in this Operator’s Manual, the
protection provided by the system may be impaired.
o Keep this manual in a safe place to ensure that it is not damaged and remains available
for use.
o This Operator’s Manual must be easily accessible at all times.

Where to find information

The following documents are provided to assist you in finding desired information
quickly:

Operator’s Manual Contains information about safety, hardware components and operating the analyzer
as well as maintenance and troubleshooting. A table of contents at the beginning of
the manual as well as at the beginning of each chapter, and an index at the end of this
manual help you to find information quickly.

Online Help Contains a detailed description of the software of the cobas c 311 analyzer. In
addition to the software description, the whole Operator’s Manual is included in the
Online Help. This makes it possible to retrieve information from both Online Help
and Operator’s Manual using the search functions available for electronically stored
documents.

COBI CD The COBI CD (Compendium of Background Information) provides you with

background information about the technologies, test principles, their theory and the
calibration methods used by the cobas c 311 analyzer. It also provides a complete
glossary. The information can be read and printed using Adobe Acrobat Reader.

You cannot run the COBI CD on the cobas c 311 analyzer because you need Adobe
Acrobat Reader to view the COBI CD. Adobe Acrobat Reader is not installed on the control
unit and must not be installed.

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Online Help system

The software of the cobas c 311 analyzer has a context-sensitive online Help feature to
aid you in operating the instrument. “Context-sensitive” means that wherever you are
located within the cobas c 311 analyzer software, choosing the Help feature displays
Help text relating to that area of the software. The online Help offers a quick and
convenient way to find information, such as explanations of screens and dialog boxes
and how to perform particular processes.

F1 Help There are two ways to enter the online Help: via the Help icon in the bottom left of the
screen or by pressing F1 on the keyboard. The context-sensitive entry displays
information relating to your current location in the software.

Customer information

Customer training Contact your local Roche service representative for any questions or information
regarding cobas c 311 analyzer training.

Contact customer service Contact your local Roche service representative for further information regarding the
cobas c 311 analyzer service agreement.

Ordering information Replacement parts, consumable materials, reagents, calibrators and controls should
be ordered from Roche Diagnostics. When ordering, please use the Roche Diagnostics
catalog number and reference name for each item. Contact your local Roche service
representative for the detailed ordering list.

Conventions used in this manual

Visual cues are used to help you locate and interpret information in this manual
quickly. This section explains the formatting conventions used in this manual.

Symbols The following symbols are used:

Symbol Used for

Safety alert symbol

Tip

a Start of procedure
o List item
e Cross-reference

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Abbreviations The following abbreviations are used:

Abbreviation Definition
A
ANSI American National Standards Institute
ASCII American Standard Code for Information Interchange
AU Analytical Unit. In the analyzer software this abbreviation is
sometimes also used to distinguish the photometric unit (AU) from
the ISE unit (ISE).
C
Cfas Calibrator for automated systems
CLAS 2 Clinical Laboratory Automation System 2
COBI CD compendium of background information
CSA Canadian Standards Association
CSF cerebrospinal fluid
CV coefficient of variation (%)
D
DAT drugs of abuse testing
dB(A) decibel weighted against the A-frequency response curve. This curve
approximates the audible range of the human ear.
DIL diluent
E
EC European Community
EMF electromotive force
EN European Standard
H
HbA1c Hemoglobin A1c, glycosylated hemoglobin
I
ICVC initial cassette volume check
IEC International Electrotechnical Commission
INC. incubator bath
IS internal standard for the ISE unit
ISE ion selective electrode (ISE unit)
IVD in vitro diagnostic
IVDD In vitro diagnostics directive
K
KCL potassium chloride, reference solution for ISE unit
kVA kilovolt-Ampere. Unit for expressing rating of AC electrical
machinery.
L
LIS laboratory information system
LLD liquid level detection
M
MSDS material safety data sheet
N
n/a not applicable

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Abbreviation Definition
P
P photometric unit of the analyzer
Q
QC quality control
R
RCM reaction calculation mode
REF reference solution for ISE unit
S
SD standard deviation
SIP ISE sipper syringe
STAT short turn around testing
Std standard, commonly used for calibrator
U
UL Underwriters Laboratories Inc.

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 System description A

1 General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Description of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
3 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-67
cobas c 311 analyzer 1 General safety information
Table of contents

General safety information

Before you start working with the cobas c 311 analyzer, it is essential that the
warnings, cautions, and safety requirements contained in this manual, as well as the
explanations of the safety labels to be found on the analyzer are read and understood
by the user.

In this chapter Chapter 1

Safety classifications ................................................................................................... A-5
Safety precautions ...................................................................................................... A-6
Operator qualification .......................................................................................... A-6
Safe and proper use of the analyzer ..................................................................... A-6
Miscellaneous safety precautions ........................................................................ A-7
Safety summary .......................................................................................................... A-8
Warning messages ................................................................................................ A-8
Electrical safety ............................................................................................... A-8
Biohazardous materials .................................................................................. A-8
Reagents and other working solutions .......................................................... A-9
Waste ............................................................................................................... A-9
Caution messages ............................................................................................... A-10
Mechanical safety ......................................................................................... A-10
Reagents and other working solutions ........................................................ A-10
Insoluble contaminants in samples ............................................................. A-10
Evaporation of samples or reagents ............................................................. A-11
Cross contamination of samples .................................................................. A-11
Fatigue due to long hours of operation ....................................................... A-11
Spillage .......................................................................................................... A-11
Notices ................................................................................................................ A-12
Moving parts ................................................................................................. A-12
Circuit breakers and fuses ............................................................................ A-12
Safety labels of the system ........................................................................................ A-13
Front view ........................................................................................................... A-15
Side view ............................................................................................................. A-16
Top view .............................................................................................................. A-17
Rear view ............................................................................................................. A-18
Disposal of the analyzer ........................................................................................... A-19

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Table of contents

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Safety classifications

Safety classifications

This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the
ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons:

The safety alert symbol by itself (without a signal word) is used to promote awareness to
hazards which are generic or to direct the reader to safety information provided elsewhere
in the document.

These symbols and signal words are used for specific hazards:

WARNING
Indicates a hazardous situation which, if not avoided, could result in death or serious
WARNING injury.

CAUTION
Indicates a hazardous situation which, if not avoided, could result in minor or moderate
CAUTION injury.

NOTICE NOTICE
Indicates a hazardous situation which, if not avoided, may result in property damage.

e For more information about the product safety labels, see

Safety labels of the system on page A-13.

Important information which is not safety relevant is indicated by the following

symbol:

Tip
Indicates additional information on correct use of the analyzer or useful tips.

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Safety precautions

Safety precautions

Particular attention must be paid to the following safety precautions. If these safety
precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is
important.

Operator qualification

Operators are required to have a sound knowledge of relevant guidelines and

standards as well as the information and procedures contained in the Operator’s
Manual.
o Do not carry out operation and maintenance unless you have been trained by
Roche.
o Carefully follow the procedures specified in the Operator’s Manual for the
operation and maintenance of the analyzer.
o Leave maintenance, installation or service that is not described in the Operator’s
Manual to trained Roche service personnel.
o Follow standard laboratory practices, especially when working with biohazardous
material.

Safe and proper use of the analyzer

Personal protective equipment o Be sure to wear appropriate protective equipment, including, but not limited to,
safety glasses with side shields, fluid resistant lab coat, and approved disposable
gloves.
o Wear a face shield if there is a chance of splash or splatter.

Accuracy/precision of measured An incorrect result may lead to an error in diagnosis, therefore posing danger to the
results patient.
o For proper use of the instrument, measure control samples and monitor the
instrument during operation.
o Do not use reagents that have exceeded their expiration date otherwise inaccurate
data may be obtained.
o For diagnostic purposes always assess the results in conjunction with the patient’s
medical history, clinical examination and other findings.

Installation o Installation must be performed by trained Roche service personnel only.

o Leave installation that is not described in the Operator’s Manual to trained Roche
service personnel. Follow the described installation instructions carefully.

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Safety precautions

Operating conditions o Operation outside of the specified ranges may lead to incorrect results or
malfunction of the instrument (see Specifications on page A-67).
o Use the instrument indoors only and avoid heat and humidity.
o Make sure that the analyzer's ventilation openings remain unobstructed at all
times.
o Perform maintenance according to the specified intervals to maintain the
operating conditions of the instrument.
o Keep the Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use. This manual must be easily accessible at all times.

Approved parts Use of non-approved parts or devices may result in malfunction of the instrument
and may render the warranty null and void. Only use parts and devices approved by
Roche.

Third-party software Installation of any third-party software that is not approved by Roche may result in
incorrect behavior of the analyzer. Do not install any non-approved software.

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may damage the analyzer or lead to
data loss. Perform regularly backups of measurement results. Operate only with an
uninterruptible power supply. Do not switch off power while the PC accesses the hard
disk or diskette.

Electromagnetic fields Devices that emit electromagnetic waves may cause the instrument to malfunction.
Do not operate the following devices in the same room where the analyzer is installed:
o Mobile phone
o Transceiver
o Cordless phone
o Other electrical devices that generate electromagnetic fields

Instrument unused for an If the instrument is not used for an extended period of time, the main circuit breaker
extended period of time switch must be set to OFF. Remove and refrigerate any remaining reagents. For
further information, call technical support.

Relocation and transportation Do not attempt to relocate or transport the analyzer. Leave relocation and
transportation to personnel trained or authorized by Roche.
e For information about disposal of the analyzer, see:
Disposal of the analyzer on page A-19

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Safety summary

Safety summary

This safety summary contains the most important and general warning and caution
messages. Additionally, you will find specific safety information at the beginning of
Part Operation and Part Maintenance.

Warning messages

List of warning messages

Before operating the analyzer, read the warning messages contained in this summary
WARNING carefully. Failure to observe them may result in death or serious injury.

Electrical safety

Electrical shock by electronic equipment

Removing the covers of electronic equipment can cause electrical shock, as there are high
voltage parts inside. In addition, opening the top cover and touching the ultrasonic mixing
mechanism during operation can also cause electrical shock.
o Do not attempt to work in any electronic compartment.
o Do not remove any cover of the instrument other than those specified in the Operator’s
Manual.
o Do not open the top cover and touch the ultrasonic mixing unit during operation or
when the analyzer performs maintenance.
o Installation, service, and repair must only be performed by personnel authorized and
qualified by Roche.
o Observe the system safety labels illustrated on pages A-15 to A-18 and in particular
the following: F-5, R-1.

Biohazardous materials

Infection by samples and associated materials

Contact with samples containing material of human origin may result in infection. All
materials and mechanical components associated with samples of human origin are
potentially biohazardous.
o Follow standard laboratory practices, especially when working with biohazardous
material.
o Keep the top cover and the front cover closed and in place while the instrument is
operating.
o When working with open top cover while the instrument is powered on (e.g., for
cleaning or maintenance), always put the analyzer in Maintenance mode or in
Shutdown status first.
o Be sure to wear appropriate protective equipment, including, but not limited to, safety
glasses with side shields, fluid resistant lab coat, and approved disposable gloves.
o Wear a face shield if there is a chance of splash or splatter.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If sample or waste solution comes into contact with your skin, wash it off immediately
with soap and water and apply a disinfectant. Consult a physician.

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Safety summary

Infection and injury due to sharp objects

When wiping probes, use several layers of gauze and wipe from the top down.
o Be careful to not puncture yourself.
o Be sure to wear appropriate protective equipment, for example gloves. Take extra care
when working with protective gloves; these can easily be pierced or cut, which can
lead to infection.

Reagents and other working solutions

Skin inflammation or injury caused by reagents and other working solutions

Direct contact with reagents, detergents, cleaning solutions, or other working solutions
may cause skin irritation, inflammation, or burns.
o When handling reagents, exercise the precautions required for handling laboratory
reagents. Be sure to wear protective equipment (such as goggles, gloves).
o Observe the cautions given in the package insert and observe the information given in
the Material Safety Data Sheets available for Roche reagents and cleaning solutions.
o If a reagent, detergent or other working solution comes into contact with your skin,
wash it off immediately with water and apply a disinfectant. Consult a physician.

Waste

Infection by waste solution

Contact with waste solution may result in infection. All materials and mechanical
components associated with the waste systems are potentially biohazardous.
o Be sure to wear protective equipment. Take extra care when working with protective
gloves; these can easily be pierced or cut which can lead to infection.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If waste solution comes into contact with your skin, wash it off immediately with water
and apply a disinfectant. Consult a physician.
o Observe the system safety labels illustrated on pages A-15 to A-18 and in particular
the following: F-3, F-6, S-1, R-3.

Contamination of the environment by waste solution and solid waste

The waste of the analyzer is potentially biohazardous.
The analyzer discharges two kinds of waste solutions:
o Concentrated waste solution that contains highly concentrated reaction solution. This
waste must be treated as infectious waste.
o Dilute waste: Rinsing water from cell wash or water from the incubation bath.
When disposing of any waste generated by the analyzer, do so according to the
appropriate local regulations.

e For information about disposal of the instrument, see

Disposal of the analyzer on page A-19

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Safety summary

Caution messages

List of caution messages

Before operating the analyzer, read the caution messages contained in this summary
CAUTION carefully. Failure to observe them may result in minor or moderate injury.

Mechanical safety

Personal injury due to contact with moving parts

o Keep the top cover and the front cover closed and in place while the instrument is
operating.
o When working with open top cover while the instrument is powered on (e.g., for
cleaning or maintenance), always put the analyzer in Maintenance mode or in
Shutdown status first.
o Only trained personnel should have access to the keys to the protective covers of the
instrument.
o Do not touch any parts of the instrument other than those specified. Keep away from
moving parts during instrument operation.
o Only load samples onto the sample disk when the green Access Sample Disk lamp
next to the sample disk is on. This indicates that the sample disk will not rotate until
renewed operation is actively initiated by the operator.
o During operation and maintenance of the instrument, proceed according to the
instructions.
o Observe the system safety labels illustrated from page A-15 to A-18 and in particular
the following: F-1.

Reagents and other working solutions

Incorrect results due to incorrect reagent volume

Application faults may cause an undetectable loss of reagent.
o Store reagents always according to specified storage conditions.
o Do not reuse a cobas c pack or other cassette whose reagent has been spilled.
o Do not use a single cobas c pack for different instruments.

Insoluble contaminants in samples

Incorrect results and interruption of analysis due to contaminated samples

Insoluble contaminants in samples and bubbles or films inside a sample container may
cause clogging or pipetting volume shortage and lead to deterioration in measurement
accuracy.
When loading samples on the instrument, make sure that samples contain no insoluble
contaminants such as fibrin or dust.

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Safety summary

Evaporation of samples or reagents

Incorrect results due to evaporation of samples or reagents

Evaporation of samples or reagents may lead to incorrect results.
o Do not leave samples, calibrators, or quality controls that have been pipetted into a
sample container for any length of time.
o Do not use expired reagents. Do not leave reagents on the analyzer for a protracted
period of time.

Cross contamination of samples

Incorrect results due to carryover

Traces of analytes or reagents may be carried over from one test to the next.
Take adequate measures to safeguard additional testing and to avoid potentially false
results.

e For more information about avoiding carryover and cross-contamination between tests,
see Special Wash on page B-209.

Fatigue due to long hours of operation

Fatigue due to long hours of operation

Looking at the monitor screen over an extended period of time may lead to eye strain or
body fatigue.
o Take a break for 10 to 15 minutes every hour to relax.
o Avoid spending more than 6 hours per day looking at the monitor screen.

Spillage

Malfunction due to spilled liquid

Any liquid spilled on the instrument may result in malfunction, or damage of the analyzer.
o Do not place samples, reagents or any other liquid on the surface of the analyzer.
o If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be
sure to wear protective equipment.

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Safety summary

Notices

NOTICE List of notices

Before operating the analyzer, read the notices contained in this summary carefully. Failure
to observe them may result in damage to equipment.

Moving parts

Damage to the analyzer due to contact with moving parts

Contact with moving parts may bend the probes or damage some other component. If the
analyzer detects a collision, an alarm will be issued and operation will be stopped
immediately.
o Keep all covers closed and in place while the instrument is operating.
o Do not touch any parts of the instrument other than those specified. Keep away from
moving parts during instrument operation.
o Only load samples onto the sample disk when the green Access Sample Disk lamp
next to the sample disk is on. This indicates that the sample disk will not rotate until
renewed operation is actively initiated by the operator.

Circuit breakers and fuses

Damage to the analyzer due to improper use

Should one of the instrument circuit breakers or fuses blow, do not attempt to operate the
analyzer before contacting either your Roche service representative or technical support.

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Safety labels of the system

Safety labels of the system

Warning labels have been placed on the analyzer to draw your attention to areas of
potential hazard. The labels and their definitions are listed below according to their
location on the instrument.
The safety labels on the analyzer comply with the following standards: ANSI Z535,
IEC 61010, IEC 60417, or ISO 7000.

If the labels are damaged, they must be replaced by Roche service personnel. For
replacement labels, contact your local Roche representative.

Spillage warning
This label indicates that the instrument may be damaged if a spillage
occurs within the vicinity of this label.
Do not place liquids in this area.

Infection warning
This label indicates that touching the instrument mechanism can
cause infection or injury to your fingers or hands.
Do not open the top cover while the instrument is in operation. Stop
every mechanism, then open the top cover.

Protective equipment warning

This label indicates that there is a danger of coming into contact with
corrosive material within the vicinity of this label.
Wear appropriate protective equipment (such as goggles and gloves).

Warning
This label indicates that there is a danger of hazardous situations
arising within the vicinity of this label, which may result in death or
serious injury.
Refer to the Operator's Manual for instructions on safe operation.

Biohazard warning
This label indicates that there are potential biohazards within the
vicinity of this label.
The relevant laboratory procedures on safe use must be observed.

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Safety labels of the system

Electrical warning
This label indicates that there is a danger of coming into contact with
electrical components when gaining access to parts of the analyzer
marked with this label.
Refer to the Operator's Manual for instructions on safe operation.
Hot surface warning
This label indicates that the area within the vicinity of this label may
be hot.
Do not touch this area as you may be burned.
Barcode label direction
This label indicates that the barcode label has to be on the right side
when inserting the cobas c pack or other cassette into the reagent
compartment.
Do not turn the cobas c pack the other way around as severe
malfunctions may occur.

The following sections briefly describe the meaning of the safety labels in the context
of where they occur on the instrument.
e For detailed information about the safety labels on the instrument, see:
Front view on page A-15
Side view on page A-16
Top view on page A-17
Rear view on page A-18

In addition to safety labels on the instrument there are safety notes in the
corresponding parts of the Operator’s Manual and Online Help.
e For more information, see:
Part Operation on page B-1
Part Maintenance on page C-1

These safety notes give more detailed information about potentially hazardous
situations that may arise during daily operation or when carrying out maintenance
procedures.
When working with the analyzer, be sure to observe both the safety labels on the
instrument and the safety notes in the Operator’s Manual and Online Help.

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Safety labels of the system

Front view

F-1
F-1

F-2
F-2

F-3
F-3
F-4
F-4

F-5
F-5 F-6
F-4 F-7
F-5

Figure A-1 Front view of the analyzer

F-1 Warning: Possibility of infection or injury due to

contact with operating mechanisms!

F-2 Warning: Fingers or skin may be pinched by syringe

(when plunger is moving).
Caution: Loose nipple may lower measurement
precision.
F-3 Warning: Possibility of infection due to contact with
sipper syringe!

F-4 Caution: Detergent and/or reagent may cause skin

irritation!

F-5 Warning: Possibility of electrical shock inside the

instrument. Do not remove the cover!

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Safety labels of the system

F-6 Warning: Possibility of infection due to contact with

vacuum tank inside!

F-7 Caution: Follow all instructions carefully during

water tank maintenance!

Side view

S-1

Figure A-2 Right side of the analyzer

S-1 Warning: Possibility of infection due to contact with

waste solution in waste solution tank!

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Safety labels of the system

Top view

T-1 T-2 T-3 T-4

T-5 T-6 T-7 T-8

Figure A-3 Top view of the analyzer

T-1 Warning: Possibility of burning yourself on the lamp

or the lamp housing when replacing the photometer
lamp!
T-2 Warning: Possibility of injury or infection due to
contact with moving mechanism!

T-3 Caution: Touching the ISE Ref. tube during analysis

may lower measurement precision!

T-4 Make sure the cobas c pack is facing in the right

direction when loading cassettes!

T-5 Warning: Possibility of infection due to contact with

parts of the ISE measuring compartment!

T-6 Caution: Opening the cover of the ISE measuring

compartment may lower measurement precision!

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Safety labels of the system

T-7 Warning: Your fingers or hand may be pinched by

the reagent disk during operation!

T-8 Spilled liquids, e.g. samples or detergents, may

cause instrument damage.

Rear view

R-1
R-1 R-2
R-2 R-3
R-3

Figure A-4 Rear view of the analyzer

R-1 Warning: Possibility of electrical shock. Do not

remove the cover!

R-2 Follow all instructions carefully during water filter

maintenance!

R-3 Warning: Possibility of infection due to contact with

ISE waste solution!

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Disposal of the analyzer

Disposal of the analyzer

Infection by a potentially biohazardous instrument

The instrument must be treated as potentially biohazardous waste. Decontamination (i.e., a
WARNING combination of processes including cleaning, disinfection and/or sterilization) is required
before reuse, recycling, or disposal of the instrument.
Dispose of the instrument according to the appropriate local regulations. For more
information, contact your Roche representative.

Disposal of control unit components

Components of your control unit (such as the computer, monitor, keyboard) which are
marked with this symbol are covered by the European Directive on Waste Electrical and
Electronic Equipment (WEEE, 2002/96/EC).
These items must be disposed of via designated collection facilities appointed by
government or local authorities.
For more information about disposal of your old product, please contact your city office,
waste disposal service or your Roche representative.
Constraint:
It is left to the responsible laboratory organization to determine whether control unit
components are contaminated or not. If contaminated, treat them in the same way as the
instrument.

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Table of contents

Description of the analyzer

This chapter provides a detailed description of the control unit, the sampling unit, the
components of the reaction disk and the reagent area as well as the ISE unit. The
sample containers and other system components are also described in this chapter.

In this chapter Chapter 2

Overview ................................................................................................................... A-23
Areas and components of the analyzer .............................................................. A-24
Photometric unit .......................................................................................... A-24
ISE unit ......................................................................................................... A-25
Other Components ...................................................................................... A-25
Basic specifications and system characteristics ................................................. A-26
Power switches .......................................................................................................... A-27
Control unit .............................................................................................................. A-28
Computer ............................................................................................................ A-29
Touchscreen Monitor ......................................................................................... A-29
Keyboard ............................................................................................................. A-29
Mouse .................................................................................................................. A-30
Printer ................................................................................................................. A-30
System interface port .......................................................................................... A-30
cobas® link ................................................................................................................ A-31
Overview ............................................................................................................. A-31
Main functions ................................................................................................... A-32
Working with cobas link functions ................................................................... A-33
Using e-barcodes via download ................................................................... A-33
Using the backup function ........................................................................... A-34
Using e-package inserts ................................................................................ A-34
Brief introduction to the cobas e-library .................................................... A-34
Sampling area components ...................................................................................... A-36
Sample disk ......................................................................................................... A-37
STAT positions .............................................................................................. A-37
Sample detectors and barcode readers ........................................................ A-37
Sample pipetting system .................................................................................... A-39
Sample pipetter ............................................................................................. A-39
Sample probe rinse station ........................................................................... A-39
Sample syringe .............................................................................................. A-40
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Table of contents

Sample tubes and cups ....................................................................................... A-41

Categories of samples ................................................................................... A-41
Sample containers ........................................................................................ A-41
Barcoded and non-barcoded samples ......................................................... A-42
Reagent area components ........................................................................................ A-43
Reagent compartment ........................................................................................ A-43
Reagent pipetting system ................................................................................... A-44
Reagent pipetter ............................................................................................ A-44
Reagent probe rinse station .......................................................................... A-45
Reagent syringe ............................................................................................. A-45
Reagent management system ............................................................................. A-46
Reagent loading station ................................................................................ A-46
Barcode reader .............................................................................................. A-47
Piercer ........................................................................................................... A-47
Reaction disk area components ............................................................................... A-48
Reaction disk ...................................................................................................... A-48
Ultrasonic mixer ................................................................................................. A-49
Reaction bath ...................................................................................................... A-50
Top cover ............................................................................................................. A-50
Photometer ......................................................................................................... A-51
Cell rinse unit ..................................................................................................... A-52
Flow of photometric analysis ............................................................................. A-54
Reaction monitoring .......................................................................................... A-57
ISE area components ................................................................................................ A-58
ISE sipper mechanism ........................................................................................ A-59
ISE measuring system ........................................................................................ A-60
ISE reagent compartments ................................................................................. A-60
Flow of an ISE analysis ....................................................................................... A-61
Behind the front doors ............................................................................................. A-63
Vacuum system ................................................................................................... A-63
Water supply ....................................................................................................... A-63
Sound volume adjustment knob ....................................................................... A-64
Auxiliary reagents and cleaning solutions ......................................................... A-64
Rear view ................................................................................................................... A-65

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Overview

Overview

The Roche/Hitachi cobas c 311 analyzer is an automated, software-controlled system

for clinical chemistry analysis. It is designed for both quantitative and qualitative in
vitro determinations using a large variety of tests for analysis.
The cobas c 311 analyzer:
o performs photometric assays and ion-selective electrode measurements and
o uses serum/plasma, urine, CSF, and supernatant sample types.
It is ready for use 24 hours a day and well-suited for all small to medium workload
requirements.

Main components The main components of the cobas c 311 analyzer are:
o Analytical unit: performs the measurements.
o Control unit: controls and monitors the complete analytical process, saves and
outputs measurement results and supports maintenance functions.

A Analytical unit (analyzer) B Control unit

Figure A-5 The cobas c 311 analyzer

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Overview

Areas and components of the analyzer

The analyzer comprises a photometric unit and an ISE unit (for ion-selective
electrode [ISE] determinations).

A
E

F
C

A Reaction disk area D ISE area

B Sampling area with the sample pipetter E Reagent pipetter
C Sample disk F Reagent loading area (for cobas c packs)
G Reagent compartment

Figure A-6 Areas of the cobas c 311 analyzer

Photometric unit
The photometric unit provides the analyzer with a flexible photometric method of
assaying up to 300 in vitro tests per hour on a wide range of analytes. The following
are the main components of the cobas c 311 analyzer:
o Sampling system
o Reagent system
o Reaction disk system

Sampling system The sampling system is composed of a sample disk, a sample pipetter (consisting of a
pipetter arm and the sample probe), a sample syringe, and a rinse station for internal
and external rinsing of the sample probe.
e See Sampling area components on page A-36.

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Overview

Reagent system The reagent system is composed of a refrigerated reagent compartment consisting of
two storage rings for cobas c packs, and a reagent pipetting system. The reagent
pipetting system consists of a reagent pipetter (consisting of a pipetter arm and the
reagent probe), cap piercing device, a reagent syringe, and a rinse station for internal
and external rinsing of the reagent probe.
e See Reagent area components on page A-43.

Reaction disk system The reaction disk system is composed of a reaction disk, immersed in a reaction bath,
an ultrasonic mixing unit, a photometric measuring system, and a cell rinse unit for
cleaning the reaction cells once test measurement is complete.
e See Reaction disk area components on page A-48.

ISE unit
Moreover, the cobas c 311 analyzer has an integrated ISE unit, which provides the
system with a potentiometric method for assaying sodium, potassium and chloride
samples. The ISE unit can process up to 150 samples per hour. The following are the
main components of the ISE unit:
o ISE measuring compartment with measuring cartridges for Cl–, K+, Na+ and
Reference cartridge
o ISE sipper mechanism
o ISE reagent compartment
e See ISE area components on page A-58.

Other Components
Other components of the analyzer are the following:
o Water supply
o Vacuum system
o System interface port
o Waste solution container

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Overview

Basic specifications and system characteristics

Figure A-7 Front view of the cobas c 311 analyzer

Basic specifications cobas c 311 analyzer

o Up to 300 photometric tests/h

o Up to 450 ISE tests/h (150 samples/h)
o 42 positions for cobas c packs (or COBAS INTEGRA cassettes)

100 applications:
o 86 photometric applications
o + 3 ISE applications + 3 serum indices + 8 calculated tests
Table A-1 Basic specifications of the cobas c 311 analyzer

System characteristics o Quick STAT sample processing

o Automated maintenance functions
o Automatic rerun capability
o Automatic calibration notification
o Automatic quality controls (Auto QC)
o Automatic sample dilution capabilities
o Non-contact ultrasonic mixing
o Reduced water consumption
o HbA1c whole blood support
e For detailed specifications of the analyzer, see:
Specifications on page A-67

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Power switches

Power switches

There are two types of power switches: one power switch each for the analytical unit
and the control unit, and in addition the superordinate power switch (main circuit
breaker).

A B C D

A Power switch of the analytical unit D Main circuit breaker of the analytical unit
B Maintenance switch
C Power switch of the control unit

Figure A-8 Power switches of the analyzer

Power switch Dependent components

Power switch of analytical unit Analytical unit except for cooling unit (at the right side),
used for powering on or shutting down the instrument
Maintenance switch Turns off the low voltage power to the pipetters, the sample
disk and the reaction disk, used for any actions which
require the top cover to be open while the analyzer remains
powered on
Power switch of control unit Personal computer
Main circuit breaker Whole analyzer including the cooling unit (at the rear
side), usually turned on for keeping the reagent cooling
unit active.
Table A-2 Power switches of the analytical unit and dependent components

Correct order for switching on Please note that there is a prescribed order for switching on and off. The following
and off order must be observed:
o Warning: Do not switch on the analyzer unless you have been trained by Roche
and unless you are familiar with the safety precautions.
o For switching on, the analytical unit has to be switched on before the control unit.
o For switching off (shutdown), the control unit has to be switched off first by
choosing Shutdown from the software. After the computer power supply has
turned off, switch off power for the analytical unit, monitor and printer.

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Control unit

Control unit

The control unit uses a graphic user interface to control all instrument functions. The
following are components of the control unit:

A Touchscreen Monitor C Height adjusting lever

B Keyboard/Mouse D Computer
(the cobas link data station is not visible here)

Figure A-9 Control unit

NOTICE Damage to the analyzer due to magnetic fields

Keep the touchscreen, computer and any disks away from magnetic fields.

Components of the control unit are subject to change without prior notice.

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Control unit

Computer

The computer monitors the functions and operational modes of the analyzer.
A hard disk drive is used to store system operating parameters as well as data from
patient samples, controls, and calibrators.
A 3½ inch floppy disk drive and a DVD-RW rewrite device are available for reading
and writing parameters and other information for backup purposes. The DVD drive
is also used for installation of software.

Only Roche technical support may install software onto the analyzer.

e For a description of the analyzer software, see:

General description of the user interface on page B-7
Main menus on page B-11
Software elements on page B-17

Touchscreen Monitor

The system is equipped with a 17" color monitor with touchscreen adapter. The
monitor is used:
o To display information
o To navigate through the software
o To initiate instrument functions
Use your finger to touch what you want to request or change directly on the screen.
Most of the items within the software can be accessed using the touchscreen. Touch
the item desired (for example, menu bar, list box, text box, button, etc.) to complete
your task. For example, to display the Data Review screen in the Workplace menu,
touch Workplace, then the Data Review tab.

When touching the screen, be sure to “tap”, not “press”. The tap must be of short duration.

Selecting Items To select a consecutive range of items in a list, press the Shift key and touch the first
item in the range. While continuing to press the Shift key, touch the last item in the
range. All items, including the first and last items touched in the range, are
highlighted. You may also touch the first item in the list and drag your finger to the
last item in the list.
To select multiple, nonconsecutive items, press the Ctrl key, then touch the desired
items.

Height adjusting lever To adjust the height of the monitor base, lift the lever.

Keyboard

A 101-key enhanced keyboard is used to navigate through the software and to enter
information.
Most items that can be accessed by means of the touchscreen can also be accessed by
means of the keyboard.
e For more information, see Shortcut keys on page B-24

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Control unit

Mouse

A mouse is available to navigate through the software.

The mouse can be used to select items on the screen and to place the cursor at an
insertion point in a text box. To select an item using the mouse, move the mouse over
the item and then click.

Printer

The system supports a graphics-capable printer. Patient results can be printed in

report format (long) or in monitor format (short). The printer can be ordered as an
optional accessory.
e See Report Format on page B-214.

Only Roche technical support may install and connect the printer.

System interface port

The following components take part in the data communication within the analyzer
and its network environment:
o Connected analyzer
o cobas link
o Host computer
There are two devices to accomplish the data communication: A serial port for
bidirectional communication with the Host computer and a hub for network
connections. The hub is located on the PC stand.
e See System interface on page A-75.

Incorrect results or damage to the analyzer due to wrong installation

o The connection between control unit and analytical unit must be done by Roche
CAUTION technical support only.
o Do not use connection cables other than the cables provided by Roche technical
support.

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cobas® link

cobas® link

Overview

cobas link platform The cobas link platform is the gateway for retrieving and distributing information -
such as instructions for use, value sheets, important notes, and test- and lot-specific
analyzer settings - from Roche TeleService-Net to cobas analyzers in the laboratory.
cobas link is an integral and mandatory part of the cobas modular platform analyzers.

TeleService-Net (TSN) TeleService-Net is the technical infrastructure to provide cobas analyzers and
operators with important product information from Roche. TeleService-Net offers
several applications to manage and display data and information of remotely
connected instruments.

TeleService-Net

cobas link
data station

cobas analyzers

Figure A-10 The cobas link platform

cobas link data station The cobas link data station is a dedicated desktop computer with keyboard, mouse,
monitor, and printer.

cobas e-library The cobas e-library (e-library) is the user interface for working with cobas link on the
cobas link data station.
The main application on cobas link for the operator is the cobas e-library, consisting
of e-package inserts and e-barcodes. This application is used for searching, reviewing,
and printing of e-package inserts.
There is a separate Operator’s Manual for the cobas e-library available.
e For more information on working with the e-library, refer to the cobas e-library
Operator’s Manual.

cobas link update process cobas link receives data from TSN about the applications, calibrators, and controls
used on cobas analyzers. This ensures that the most up-to-date product information
is always available in the laboratory. All information relevant for the analyzer can be
downloaded from cobas link.

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®
cobas link

cobas link is updated daily via an automatic download if connected to the internet or
a phone line. The cobas link data station connects to TSN, typically overnight,
depending on the customer's requirements (configured by Roche service engineers
during installation). While connected, all newly available data are downloaded from
the TSN to your cobas link data station.
If your laboratory does not have an online connection to TSN, the TSN data is
provided on a CD, distributed by your local Roche organization.
e For more information on working with CD, refer to the cobas e-library Operator’s
Manual.

Main functions

From the operator’s point of view the main functions of cobas link are:

Analyzer control unit

Upload
backups

Download
e-barcodes

Provide
e-package inserts

cobas link data station

Figure A-11 cobas link - main functions

e-package inserts o The cobas e-library stores many documents (e-package inserts) such as the
instructions for use for the applications, information on controls, calibrators, and
announcements.
e See Using e-package inserts on page A-34

e-barcodes o Providing e-barcodes (e-BC) like application parameters to be downloaded from

cobas link to the analyzer by the operator. e-BCs are instrument readable only.
e See Using e-barcodes via download on page A-33

Backup function o Providing the possibility of important data backup for the cobas c 311 analyzer.
e See Using the backup function on page A-34

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cobas® link

Working with cobas link functions

This section explains the working principles of the main cobas link functions.

Using e-barcodes via download

The operator downloads the required e-barcodes from the cobas link data station to
the analyzer.
The following types of e-barcodes are available:
o Application data
o Calibrator data
o Control data
The following figure gives an overview of the installation process.

Figure A-12 Installation process of a new cobas application

If the data of a particular application (application parameters, calibrator data, and

control data) is not available on the analyzer, it has to be downloaded from cobas link.
e For more information, see:
Loading or updating applications on page B-174

Reassigned calibrator or control values have to be downloaded manually!

If calibrator or control values for a particular calibrator or control have been reassigned,
you are informed by means of the e-library. In this case you have to start the download
process for the particular calibrator or control manually to update the calibrator or control
data.

A detailed description for installing new applications, calibrators, and controls is

given in the corresponding chapters.
e For a more detailed description see:
To download application parameters from cobas link on page B-174
To download calibrator data from cobas link on page B-131
To download control data from cobas link on page B-165

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cobas link

Using the backup function

Instrument and process related data can be stored to the hard disk of the cobas link
data station for disaster recovery. In order to initiate this backup function it is
necessary to include the cobas link Essential Information Upload function in a
maintenance pipe that is carried out daily (e.g., the Power On pipe).
This item can only be performed in a Maintenance Pipe.
e For more information, see
Defining and editing maintenance pipes on page C-11
Recommended maintenance pipes on page C-15
cobas link Essential Information Upload on page C-23

Perform daily backups to preserve the operational availability of the analyzer!

Include the cobas link Essential Information Upload function into a maintenance pipe that
is executed daily. If a hard disk error on the control unit occurs, the last backup can be
restored from the cobas link data station.

Using e-package inserts

You can view and print package inserts as required through the e-library. The
following electronic documents are provided via the e-library:
o e-package inserts (e-PI)
O Instructions for use
O Value sheets of calibrators and controls
O Important notices (for example reassigned control values)
O Announcements of the local Roche organizations

Check your cobas e-library daily to obtain important information!

It is important to check your cobas e-library daily because important information that is
necessary for analysis—like reassigned control values—is announced through the
cobas e-library.

Brief introduction to the cobas e-library

The following section explains how to start the e-library application and gives an
overview over the user interface.

a To start the e-library

1 Log on to the cobas link data station, by entering the user name and password for
the e-library.
2 Confirm with OK.
The start screen of the e-library is displayed (New Entries).

Overview of the user interface The screen in Figure A-13 is for illustrative purposes only. It shows the New Entries
for an analyzer with clinical chemistry and immunological modules.

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D
B

Figure A-13 Introduction to the cobas e-library user interface

The e-library user interface comprises the following components:

A Navigation bar has a tab for the e-library application. Links to other applications
can also appear in this bar. The e-library application opens by
default.
B Navigation menu provides links to the e-library application screens.
C Online Help accesses the context-sensitive online help. A quick and convenient
way to find information, such as explanations of screens and
dialog boxes and how to perform particular processes.
D Screen header displays the path of your active screen. The active operator name
is displayed on the right hand side of the Screen header.
E Message List displays the list of bulletins, letters, package inserts, value sheets
and product announcements.
F Footer explains the icons used in the document and version columns.

The e-library offers the following important functions:

o Show new e-library documents (New Entries screen), based on Preferences Screen
o Search for documents in the e-library archive (Search screen)
o Specify applications, calibrators, and controls currently used on the system
(Preferences screen)

o Check the New Entries screen on a daily basis to make sure that you receive all
important information from Roche.
o Whenever you load a new application, make sure that you always add it to your
Preferences. Only the items you have selected in Preferences will be displayed on the
New Entries screen.
o If the cobas link data station is not connected to TeleService-Net, you have to update
regularly via CD (Update e-library screen).

e For more information on working with the e-library, refer to the cobas e-library
Operator’s Manual.

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Sampling area components

Sampling area components

The following components belong to the sampling area:

o A sample disk
o A sample pipetter (consisting of pipetter arm and probe) for pipetting samples
from the sample tubes to the reaction cells on the reaction disk
o A metal shield pipe that protects the sample probe against electrostatic noise
o The detergent bottles for the auxiliary reagents Multiclean and SMS / Acid Wash
o A rinse station for internal and external rinsing of the sample probe

G
A

D
H

A Sample pipetter E Reaction disk

B Shield pipe (against electrostatic noise) F Rinse station with drying cylinder
C Sample probe detergent bottles: G Access Sample Disk lamp
1: Sample cleaner 1 (Multiclean)
2: Sample cleaner 2 (SMS)
D Sample disk

Figure A-14 Sampling area components

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Sampling area components

Sample disk

The sample disk is located at the front on the left side. The rotor consists of two
concentrical rings with a total number of 108 positions for samples.
It is possible to reserve some positions for STAT samples. In addition, the sample disk
can hold different sample types, QCs and calibrators. When working without barcode
the positions for auto QC and calibrators must be defined by means of the software.
The position W1 is reserved for tubes with ISE cleaning solution/SysClean and the
position W2 for ISE Activator.
For easier adding and removing of samples, the sample disk could be taken out of the
analyzer. Make sure that the shield pipe is lifted up first.

Personal injury due to touching moving parts

Only load samples onto the sample disk when the green Access Sample Disk lamp next to
CAUTION the sample disk is on. This indicates that the sample disk will not rotate until renewed
operation is actively initiated by the operator.

Access Sample Disk lamp The green Access Sample Disk lamp displays the following statuses:

Access lamp Sample disk ...

Green Can be accessed
Blinking Starts to rotate soon
OFF Must not be accessed
Table A-3 Statuses of the Access Sample Disk lamp

STAT positions
Use the STAT positions to start analysis of any samples directly, by-passing all samples
in the sample disk. The number of reserved positions for STAT samples is definable
(on the inner ring). A sample loaded in a STAT position will be processed with higher
priority than other samples on the sample disk.

Sample detectors and barcode readers

When samples are loaded onto the sample disk, they pass by a sample detector and a
barcode reader. A sample detector and a barcode reader are located on the inner and
outer sides of the sample disk area. They scan the inner and the outer ring of the
sample disk for the presence of samples and barcodes (see Figure A-15 on page A-38).

Sample detector The sample detectors detect if there is a sample present in a sample position.

Barcode reader The barcode readers scan the barcode on each sample.

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Sampling area components

B
C

A Barcode reader (long slot) for outer ring C Barcode reader and sample detector for
B Sample detector (short slot) for outer ring inner ring

Figure A-15 Barcode readers and sample detectors in sample disk area

Barcode scan range The barcode label must be positioned so that it can be scanned through the notch
between the sample cup positions (see Figure A-16 on page A-38).

A
max. 88 mm

A Sample tube (100 mm) C Barcode scan range

B Notch between sample cup positions

Figure A-16 Sample tubes on the outer ring with their barcode facing outwards

e For specifications of the correct position of the barcode label, see:

Barcode specifications on page A-76

Ensure that the sample barcodes are facing the right way so the two barcode readers can
scan them. Samples placed in the inner ring must have their barcodes facing inwards,
samples placed in the outer ring must have their barcodes facing outwards.

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Sampling area components

Sample pipetting system

The sample pipetting system is composed of a sample pipetter and a sample syringe.
After each pipetting, the sample probe is rinsed by the sample probe rinse station.

A Sample pipetter C Tip water aspiration position

B Shield pipe D Sample probe rinse station
E Drying cylinder

Figure A-17 Sample pipetting system

Sample pipetter
The sample pipetter consists of the pipetter arm and the sample probe.
When a sample tube is in the sampling position, the barcode is read three times for
safety reasons. Then the pipetter transports sample liquid from a sample tube to a
reaction cell. When aspirating, liquid level detection (LLD) is accomplished by a
highly sensitive capacitance measurement, as well as a clot detection by means of
pressure measurements.
To protect the probe against electrostatic noise, which would interfere with the
capacitance measurement, a metal shield pipe is mounted over the sampling position.
After sample has been aspirated, the probe is raised from the sample and is moved to
the reaction disk. The sample probe arm lowers the probe into the reaction cell at the
sample dispense position. Sample is dispensed while the beveled sample probe tip is
in contact with the bottom of the reaction cell. This ensures that a precise volume of
sample is deposited into the bottom of the cell even when using a low dispense
volume. The sample probe is spring-mounted on the arm to avoid damage to the
probe or reaction cell.

Sample probe rinse station

The sample probe rinse station is located between the sample disk and the reaction
disk (see Figure A-17 on page A-39). To prevent carryover, the sample probe is rinsed
here with deionized water both externally and internally before aspirating from a new
sample. After rinsing, the sample probe is dried at the drying cylinder.

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Operator’s Manual · Version 1.0 A-39
2 Description of the analyzer cobas c 311 analyzer
Sampling area components

The rinse station is the home position for the sample probe when the pipetter is in
Standby.
In addition to the rinsing between pipetting, the sample probe is washed with sample
cleaner 1 and/or 2 from the sample probe detergent bottles:
o The daily and weekly maintenance actions include the washing of the sample
probe.
o Special washes can be programmed to prevent carryover.
e For more information, see:
Auxiliary reagents and cleaning solutions on page A-64
Daily maintenance on page C-40
Weekly maintenance on page C-50
Carryover evasion on page B-105

Sample syringe
The sample pipetter is connected by tubing to the sample syringe, which controls the
pipetting action.

A C
B

A Reagent syringe C ISE sipper syringe

B Sample syringe

Figure A-18 Position of the sample syringe (inside the left front door)

The sample syringe, which is located behind the left front door of the analyzer, is filled
with degassed and deionized water. The syringe uses positive displacement to aspirate
and dispense samples by means of the sample probes.
The syringe motor retracts the plunger within the chamber of the syringe, and sample
is aspirated into the tip of the sample probe. The pipetter arm moves the sample
probe to the reaction disk. The sample probe lowers into the reaction cell and the
syringe motor reverses to dispense the sample. The pipetter arm lifts the sample probe
from the reaction cell and moves it to the sample probe rinse station.

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cobas c 311 analyzer 2 Description of the analyzer
Sampling area components

Sample tubes and cups

This section describes the different containers—sample tubes or cups—used to

supply samples to the analyzer.

Categories of samples
The cobas c 311 analyzer distinguishes the following categories of samples:
o Patient samples
O Routine samples
O STAT samples
O Rerun samples
o Calibrators
o Quality controls (QCs)

Sample containers
The following kinds of containers can be loaded onto the sample disk:
o Sample cups
O Hitachi standard cups
O Hitachi micro cups(a)
o Sample tubes (13 mm or 16 mm in diameter and 75 mm or 100 mm in length)
o In addition, non-standard tubes and false-bottom tubes can also be used.

G
H

A
B I
C J
D

E
F

A 13 mm x 100 mm tube F Hitachi standard cup

B 13 mm x 75 mm tube G Standard cup on 16 mm x 100 mm tube
C 16 mm x 100 mm tube H Micro cup on 16 mm x 100 mm tube
D 16 mm x 75 mm tube I Standard cup on 16 mm x 75 mm tube
E Hitachi micro cup J Micro cup on 16 mm x 75 mm tube

Figure A-19 Sample containers on sample disk

(a) Not applicable to calibrators and QCs

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Operator’s Manual · Version 1.0 A-41
2 Description of the analyzer cobas c 311 analyzer
Sampling area components

Sample cups can be inserted into 16-millimeter sample tubes (cup on tube) or they
can be used without tubes.
In this document, "container" is used as a generic term for all kinds of cups and tubes.
e For sample container specifications, see
Sample cups and tubes on page A-75

Barcoded and non-barcoded samples

Sample identification When operating in barcode mode, each sample’s barcode label is scanned by the
barcode reader of the sample disk. The sample barcode label provides the sample ID,
which is used for sample identification and test selection purposes.
e For specifications of barcodes and barcode labels, see
Barcode specifications on page A-76
Specifications of barcode labels on page A-77

The sample ID number provides tracking for the system. To track samples by means
of the software, select Sample Tracking from the System Overview screen.
When working with barcoded samples, only the STAT positions must be defined in
the software.
When working with Patient IDs, positions have to be assigned in the software for
routine and STAT samples for all sample types.

Non-barcode mode When operating in non-barcode mode, samples are identified by a sequence number
and their position in the sample disk. This assignment has to be done on the
Workplace > Test Selection screen.
When working with non-barcoded samples, define the position of each sample
category (controls, calibrators, and STAT positions) in the software.

Incorrect results due to sample mismatch

If samples are not placed in the proper position, incorrect measurement results may occur.
CAUTION When manually assigning positions, ensure the position is not already assigned.

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Reagent area components

Reagent area components

The following components belong to the reagent area:

o A refrigerated reagent compartment for storing up to 42 cobas c packs
o A reagent pipetter for aspirating reagents from the reagent compartment and
dispensing them to the reaction cells on the reaction disk
o A piercer for the cobas c packs
o A rinse station for internal and external rinsing of the reagent probe
o A reagent management system that controls the positions of the cobas c packs
within the reagent compartment

D
A
B

C
F

A Rinse station and drying cylinder D Cutouts for the reagent probe
B Piercer compartment E Reagent pipetter
C Reagent compartment (with cutout) F Gate to the reagent loading station
G Barcode reader

Figure A-20 Reagent area components

Reagent compartment

Reagents for photometric applications are stored in a closed, temperature-controlled

(5-15°C) compartment containing two concentric rings with a total of 42 positions
for cobas c packs. There are 14 positions on the inner and 28 positions on the outer
ring.
To prevent reagents from evaporating, the reagent compartment is equipped with a
cover. By design, this cover is not meant to be opened or removed. The cobas c packs
are placed into and removed from the compartment by way of a gate (software-
controlled access).

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Operator’s Manual · Version 1.0 A-43
2 Description of the analyzer cobas c 311 analyzer
Reagent area components

Reagent pipetting system

The reagent pipetting system is composed of a reagent pipetter and a reagent syringe.
After each pipetting, the reagent probe is rinsed by the reagent probe rinse station.

B C D

A Reagent pipetter B Reagent probe drying cylinder

C Reagent probe rinse station
D Piercer compartment

Figure A-21 Reagent pipetting system (detail view)

Reagent pipetter
The reagent pipetter transports the reagents from the reagent compartment to the
reaction disk. The pipetter is mounted on an independent x-y-motion mechanism.
Before each pipetting, the reagent probe is externally and internally rinsed with
deionized water and dried. After reagent has been aspirated, the probe moves from
the reagent compartment to the reaction disk. There, the reagent volume is dispensed
into a reaction cell containing the sample. The mechanical cycle of the cobas c 311
analyzer allows for three different reagent timings: R1, R2, and R3.
The reagent probe is equipped with a pressure sensor and a liquid level detector
(LLD). When a new cobas c pack is loaded, the pressure sensor performs an initial
volume check—also referred to as initial cassette volume check (ICVC)—for each of
the bottles in a cobas c pack, if this option has been selected. The liquid level detector
is used for measuring the volume of the ISE reagents (ISE Dil. and ISE IS). Moreover,
the reagent pipetter picks up the piercer to open the cobas c pack by piercing the tops.
e See Piercer on page A-47.

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Reagent area components

Reagent probe rinse station

The reagent probe rinse station is located between the reagent compartment and the
reaction disk. After reagent has been dispensed, the probe is always flushed internally
and externally with deionized water, and dried by the drying cylinder.
The rinse station is the home position for the reagent probe when the analyzer is in
Standby mode.
In addition to the rinsing between pipetting, the reagent probe is washed with
auxiliary reagents from cobas c packs:
o The daily and weekly maintenance actions include the washing of the reagent
probe.
o Special washes can be programmed to prevent carryover.
e For more information, see:
Auxiliary reagents and cleaning solutions on page A-64
Daily maintenance on page C-40
Weekly maintenance on page C-50
Carryover evasion on page B-105

Reagent syringe

A C
B

A Reagent syringe C ISE sipper syringe

B Sample syringe

Figure A-22 Position of the reagent syringe (inside the left front door)

The reagent syringe is located behind the left front door of the analyzer. It is filled
with degassed and deionized water, using positive displacement to aspirate and
dispense reagents.

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Operator’s Manual · Version 1.0 A-45
2 Description of the analyzer cobas c 311 analyzer
Reagent area components

Reagent management system

Reagents for all Roche applications are provided in cobas c packs (COBAS INTEGRA
cassettes can also be used). These cassettes contain from one to three specially
designed reagent bottles and have barcode labels with detailed reagent and test-related
information.
The following components belong to the reagent management system:
o Reagent disk (inside the reagent compartment)
o Reagent loading station
o Barcode reader
o Piercer

Reagent loading station

Use the reagent loading station to load and unload cobas c packs. Both processes have
to be started by means of the software (see Loading cobas c packs on page B-45).
After clicking the Loading button, the analyzer turns the reagent disk to a free
position. The reagent loading station is designed in such a way that a cobas c pack can
be loaded to only one position on the reagent disk. This rules out any possibility of
placing a cassette in a wrong position on the reagent disk or using inappropriate
reagents.

A Gate to the reagent loading station B Barcode reader

C Barcode label

Figure A-23 Scanning the barcode label on a cobas c pack

Incorrect results due to incorrect placement of reagent

If a cobas c pack (or COBAS INTEGRA cassette) is inserted the wrong way around,
CAUTION reagents will be pipetted in the wrong order, leading to incorrect results. The instrument
may also be damaged.
When inserting the cobas c pack, make sure the barcode is facing the barcode reader.

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Barcode reader
The barcode reader scans data from the barcode label on the cobas c pack and checks
its integrity.
e For more information about the encoded data on the barcode label, see
Barcode label on page B-102.

After opening the gate of the reagent loading station, the operator scans the barcode
label and places the cobas c pack into the free position.

If the barcode of a cobas c pack or other cassette is unreadable, this cassette is not
accepted. The operator is requested to close the gate.

If the cobas c pack currently being scanned has not been on the analyzer before, the
analyzer registers the initial capacity, pierces the caps of the bottles and performs an
initial cassette volume check (ICVC)—if this option has been selected.
e For more information about the registration of cobas c packs, see
Reagent registration on page B-104.

Piercer
When a new cobas c pack is loaded into the reagent compartment, the reagent
pipetter picks up the piercer, which is kept near the rinse station. The piercer lowers
and pierces the caps of the reagent bottles in the cassette through the cutouts in the
compartment cover.

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Operator’s Manual · Version 1.0 A-47
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Reaction disk area components

Reaction disk area components

The following components belong to the reaction disk area:

o A reaction disk with the reaction cells, which are immersed in the reaction bath
o An ultrasonic mixing unit for non-contact mixing of reaction mixtures (15 levels)
o A photometric measuring system that continually measures the absorbance of the
reaction mixture in each of the reaction cells
o A cell rinse unit for cleaning the reaction cells once test measurement is complete

E
A
F
B

G
C

A Photometer detector (hidden) D Water level sensor

B Reaction cell rinse unit E Reaction bath overflow
C Reaction disk F One segment of 11 reaction cells
G Cell covers
H Ultrasonic mixing unit

Figure A-24 Reaction disk area

Reaction disk

The reaction disk of the cobas c 311 analyzer carries 66 reusable plastic reaction cells
(cuvettes). These reaction cells are grouped together in six segments with 11 cells
each. All reaction cells are seated in a controlled-temperature bath. This reaction bath
maintains the cells at the required temperature of 37 ± 0.1°C. Therefore it is also
referred to as the incubator bath.

We recommend replacing the reaction cells once a month as they gradually deteriorate
over a prolonged period of use. Always carry out wash reaction parts and cell blank
measurement after replacing the reaction cells.

e See M9: Replacing reaction cells and cleaning incubator bath on page C-62

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Reaction disk area components

C
F

A Reaction disk D Reaction bath overflow

B Water level sensor E One segment of 11 reaction cells
C Photometer lamp unit F Reaction bath (incubator bath)

Figure A-25 Reaction disk

Ultrasonic mixer

The ultrasonic mixing unit mixes the reagents within each of the reaction cells to
ensure a homogeneous distribution of reactants.
To avoid spillage, the volume of the reaction solution is checked before mixing by
calculating the pipetting volume of sample and reagent. If the liquid level is too low or
too high, an alarm is issued and mixing is not performed.
Contamination of the polished surface of the ultrasonic mixing unit will cause
inadequate mixing. It must be cleaned at least once every three months. The
ultrasonic output intensity is continually monitored. If the intensity falls below a
certain limit, an alarm (Mix.E or <Mix) is issued, and replacement of the ultrasonic
mixing unit is required. Contact your service representative for the replacement.
e See M15: Cleaning the ultrasonic mixer on page C-79.

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Operator’s Manual · Version 1.0 A-49
2 Description of the analyzer cobas c 311 analyzer
Reaction disk area components

Reaction bath

The circular reaction bath, positioned beneath the reaction disk, maintains the
reaction mixtures in the reaction cells at a temperature of 37°C. Water in the reaction
bath is circulated by a pump through a refrigeration unit where it is cooled and then
onto the heater where it is heated, as necessary, to maintain the temperature
(± 0.1°C).
Two glass windows (inner and outer) are positioned in opposite walls of the reaction
bath. These windows permit light from the photometer lamp to pass through the
reaction bath water and through the reaction cells in the bath. The light beam
emerges from the outer window of the reaction bath and enters the instrument
photometer.
A liquid level sensor detects the water level of the bath. Deionized water is
automatically added to the reaction bath, as determined by the liquid level sensor, to
compensate for evaporation. This occurs even in Standby mode.

Hitergent Hitergent is a non-ionic, bacteriostatic detergent automatically added to the reaction

bath by the reagent pipetter whenever the water is exchanged. It acts as a surfactant to
minimize the formation of bubbles that could potentially interfere with the
photometer readings. Hitergent for the reaction bath is supplied in a cobas c pack.

Top cover

The reaction disk area (as well as most of the sampling area and the reagent area) is
covered by the top cover.

Injury to fingers by top cover dropping suddenly

Be careful when opening or closing the top cover. If you let go of the handle, the top cover
WARNING may drop onto your fingers.
o Always keep a firm grip on the handle and do not let go when opening or closing the
top cover.
o If the top cover does not stay open properly, please contact your local Roche service
representative.

The top cover protects the operator from:

o injury due to contact with the moving parts
o the risk of infection through contact with splashed sample material or through
inhaling reaction solution aerosol.
Therefore, always keep the top cover closed during operation. Before opening the
cover, make sure that the analyzer is in Maintenance mode or Shutdown status first.
e For information about instrument statuses, see:
Instrument statuses on page B-32.

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Photometer

The cobas c 311 analyzer is equipped with a photometer to measure the absorbencies
of the reaction mixtures in the reaction cells.
The photometer lamp is located against the inner ring of the incubator bath beneath
the reaction disk. The detector is outside the incubator bath ring, near the cell rinse
unit.
e To locate the photometer detector, see Figure A-24 on page A-48.

Measurements are taken of all the 66 reaction cells, as the reaction disk is turning.

A B C D E F G H I J K L M

A Grating F Reaction cell and contents K Infrared cut filter

B Photometer G Incubator bath L Water jacket
C Slit H Slit (in) M Photometer lamp
D Imaging lens I Condenser lens N Detector
E Slit (out) J Mask

Figure A-26 Illustration of light path through photometer components

Photometer lamp The photometer lamp beneath the reaction disk, is encased in a constant-temperature
water jacket, which helps to maintain a constant energy output from the lamp, and
also extends the lamp life. Replace the photometer lamp if the photometer check
value at 340 nm exceeds 14000, or if lamp has been used for 750 hours or more.
e See M21: Replacing the photometer lamp on page C-96.

Light path The light from the photometer lamp passes through the following main components:
o Inner reaction bath window
o Reaction bath water
o Reaction cell and its contents
o Reaction bath water
o Outer reaction bath window
o ...and into the photometer
When the light beam enters the photometer, it strikes a diffraction grating. This
separates the light into its constituent wavelengths and reflects them onto a fixed
array of 12 photodiodes. Each photodiode is permanently positioned to detect light at
a different wavelength.

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Reaction disk area components

The computer uses the available assay parameter information to select the
wavelengths and the times at which a reaction mixture’s absorbance is read and results
calculated.
The instrument computer keeps track of which test is being performed in each
reaction cell. It also knows when each reaction cell passes through the photometer
light path. The computer uses this tracking ability and the programmed read
instructions to obtain test results.

Cell rinse unit

A Cell rinse unit B Cell rinse nozzles

C Reaction disk

Figure A-27 Reaction cell rinsing system

The cell rinse unit is located to the left of the reaction disk. It cleans, rinses, and dries
the reaction cells once the chemical reaction of the reaction mixture has been
measured. To ensure cell integrity (optical characteristics), a photometric reading of a
cell containing water is performed during the cleaning process (cell blank) and
compared with the previous stored cell blank measurement.
e For information about the used rinsing reagents, see
Auxiliary reagents and cleaning solutions on page A-64.

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Cell rinse sequence The following sequence reflects the order in which cleaning, rinsing, and cell blanking
of the reaction cells takes place.

1. A: Liquid aspiration at end of reaction 5. I: Rinse water aspiration

B: Rinse water dispense J: Rinse water dispense
2. C: Rinse water aspiration 6. K: Rinse water aspiration (nozzle tip)
D: Detergent 1 dispense (Cell wash I) 7. L: Water blank dispense
3. E: Detergent 1 aspiration M: Cell blank measurement (3 x)
F: Detergent 2 dispense (Cell wash II)(a) 8. N: Water blank aspiration (nozzle tip)
4. G: Detergent 2 aspiration O: Water blank aspiration (nozzle tip)
H: Rinse water dispense
Figure A-28 Flow of the cell rinse mechanism
(a) Cell wash II (acid wash) is only used if application requires.

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Operator’s Manual · Version 1.0 A-53
2 Description of the analyzer cobas c 311 analyzer
Reaction disk area components

Flow of photometric analysis

The following figures and descriptions help to understand the flow of photometric
analysis:
o Figure A-29 on page A-54 shows the main functions and their positions on the
reaction disk area.
o Figure A-30 on page A-55 shows the main steps of photometric analysis flow.
o Table A-4 on page A-56 explains the operating principle and the photometric
analysis flow.

A Sampling (diluted sample) E Reagent adding

B Sampling F Aspirating diluted sample and internal
C Cell rinse nozzles standard solution for ISE
D Photometer G Mixing

Figure A-29 Main functions and their positions on the reaction disk area

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1 Start

2 Resetting

3 Rinsing of reaction cuvette

4 Measurement of water blank

5 Aspiration of water

6 Sampling

7 Addition of R1, mixing

8 Addition of R2, mixing

3 minute reaction (14 measurements/reaction cuvettes)

4 minute reaction (19 measurements/reaction cuvettes)

9 Addition of R3, mixing 5 minute reaction (24 measurements/reaction cuvettes)

6 minute reaction (28 measurements/reaction cuvettes)

7 minute reaction (33 measurements/reaction cuvettes)

8 minute reaction (43 measurements/reaction cuvettes)

9 minute reaction (52 measurements/reaction cuvettes)

10 minute reaction (57 measurements/reaction cuvettes)

10 Completion of all measurements

11 Rinsing of reaction cuvette

12 Automatic stop

Figure A-30 Flow chart of the photometric analysis

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Operator’s Manual · Version 1.0 A-55
2 Description of the analyzer cobas c 311 analyzer
Reaction disk area components

Step Action
1–2 Upon start, the instrument resets the mechanisms, and then starts rinsing the
reaction cell.
In a single cycle (12 s), the reaction disk rotates by 65 reaction cells, divided into six
steps with temporary stops. The rotation steps are: +17 ♦ +24 ♦ +17 ♦ -12 ♦
+2 ♦ +17 reaction cells (+: forward, -: backward rotation, ♦: temporary stop).
3 o Using the cell rinse nozzles A/B/C in the rinsing mechanism, reaction solution
is aspirated and the reaction cell is rinsed with deionized water.
o In the next 2 cycles, the reaction cell is washed with cell detergent 1 dispensed
from the cell rinse nozzle D and aspirated from nozzle E.
o In the next 2 cycles, the reaction cell is washed with cell detergent 2 dispensed
from the cell rinse nozzle F and aspirated from nozzle G.
o Deionized water is dispensed with nozzle H, it is aspirated with nozzle I.
o Using the nozzles J/K, the reaction cell is rinsed once again with deionized
water.
Note: The numbers of the cell rinse nozzles refer to Figure A-28 on page A-53.
4 Then a water blank is measured 3 times (M) after dispensing deionized water with
cell rinse nozzle L.
If the water blank value differs by 0.1 or more from the cell blank value, that cell will
not be used for analysis.
5–6 When the reaction cell after rinsing and water blank measurement advances to the
sampling position, sampling begins.
Sampling is carried out in the order starting from the sample that will take the
longest reaction time in order to shorten the time needed for completion of data
output.
7–9 Reagents R1, R2, and R3 are usable, and will be added at the determined time points
(0, 1.5 and 5 minutes).
After one of the reagents R1, R2, and R3 has been added, the liquid in the reaction
cell will be mixed at the mixing position by means of the ultrasonic mixer.
10 Sampling is carried out every 12 s (1 cycle), and measurement is performed once in
one full turn, that is 57 times in 10 minutes. On completion of measurement, the
concentration is calculated by use of the absorbance at the specified photometric
point.
11 The instrument dispenses the reaction solution with the rinsing mechanism and
conducts washing with cell detergents and rinsing with water.
12 Then the instrument goes into Standby.
Table A-4 Schedule of the photometric analysis

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Reaction monitoring

The reaction disk rotates one turn in 12 seconds and during this time, the absorbance
is measured and stored for all of the reaction cuvettes that cross the optical path of the
photometer. These absorbance values are recorded in the reaction monitoring system.
For each reaction cell, water blank (absorbance 0) is measured, and then photometry
is performed 57 times in 10 minutes. Therefore, photometry is less affected by time
lapse. Also, the concentration can be calculated by using desired photometric points.
Absorbance

G
E
24 57
BC
7
A
1

H
F
D

0 5 10
Time / min.

A Water blank measurement E Addition of reagent 2 (R2)

B Addition of sample F Mixing of reagent 2
C Addition of reagent 1 (R1) G Addition of reagent 3 (R3)
D Mixing of reagent 1 H Mixing of reagent 3

Figure A-31 Example of a reaction course

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Operator’s Manual · Version 1.0 A-57
2 Description of the analyzer cobas c 311 analyzer
ISE area components

ISE area components

The ISE unit provides an electronic method for measuring sodium, potassium, and
chloride ion activities in samples. It is designed to process up to 150 samples per hour
(450 tests/h).
The following components belong to the ISE unit:
o ISE sipper mechanism—for aspirating ISE IS and diluted sample from reaction
cells into the measuring system
o ISE measuring compartment
o Two ISE reagent compartments —containing bottles for ISE IS, ISE Dil., and
ISE Ref. (KCL)
The ISE analysis uses the reagent pipetter for pipetting ISE IS and ISE Dil. into
reaction cells.

A
D
E
B

A ISE sipper (beneath sipper cover) C ISE reagent compartment for ISE Dil. bottle
B ISE measuring compartment D Reagent pipetter
E ISE reagent compartment for ISE IS bottle
F ISE reagent compartment for ISE Ref. bottle

Figure A-32 ISE area

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ISE area components

ISE sipper mechanism

The ISE sipper mechanism consists of a sipper nozzle and a sipper syringe.

D
A

A ISE sipper nozzle B ISE reference cartridge

C Pinch valve
D ISE measurement cartridges

Figure A-33 ISE sipper and ISE measuring system (covers removed)

Sipper nozzle The sipper nozzle aspirates either ISE IS solution or sample solution from a reaction
cell into the ISE measuring flow path. The ISE IS solution and the sample with the
diluent heat up to the measuring temperature (37°C) by the reaction bath.
The sipper nozzle is cleaned during daily maintenance.

Sipper syringe The sipper syringe is positioned behind the left front door of the cobas c 311 analyzer.
It is the rightmost syringe (to the right of the sample syringe). The syringe not only
provides the negative pressure for the sipper, it also aspirates ISE Ref. from its
container and into the reference cartridge flow path when the pinch valve is closed.

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Operator’s Manual · Version 1.0 A-59
2 Description of the analyzer cobas c 311 analyzer
ISE area components

ISE measuring system

The ISE measuring system is contained in a temperature-controlled compartment

(37 °C). It is composed of three channeled sample/ISE IS measurement cartridges and
one reference cartridge.

Measurement cartridges Three cartridges, each containing an ion-selective electrode, are directly connected to
form a flow path for the diluted sample and the ISE IS solutions.

Reference cartridge The reference cartridge contains the reference electrode. ISE Ref. is aspirated through
a separate flow path by the sipper syringe. A reference electrode potential is registered.

Colors of the cartridges The electrode potentials are measured in the color-coded cartridges as follows:

1 Green Chloride Cl–

2 Red Potassium K+
3 Yellow Sodium Na+
Light blue Reference electrode

The difference between the potentials at reference electrode and ion-selective

electrode equals the electromotive force (EMF). For every test, the EMF of both ISE IS
and diluted sample solution are measured for each sort of ions (Cl–, K+, and Na+).
From these EMF values the results are calculated.

ISE reagent compartments

The two ISE reagent compartments contain three reagent bottles: Internal standard
(ISE IS), diluent (ISE Dil.) and reference solution (ISE Ref.).
e To locate the ISE reagent bottles, see ISE area on page A-58 (E and F).

The front reagent compartment contains a ISE Ref. (KCl) bottle. The sipper syringe
aspirates ISE Ref. to reference electrode when the pinch valve of the ISE measuring
system is closed.
The rear reagent compartment for ISE IS and ISE Dil. is equipped with level sensors
for each reagent bottle.

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ISE area components

Flow of an ISE analysis

It usually takes three cycles to complete one ISE measurement, since internal standard
(ISE IS) is measured before and after sample. However, if only ISE is continuously
measured, two cycles are sufficient for one measurement, since the ISE IS measured
after sample can be used in common with the ISE IS to be measured before the
following sample. The final ISE measurement always requires three cycles.

In case of continuous ISE measurements In case of measurement of ISE and

(two cycles) photometric assay (three cycles)
ISE IS ISE IS
Meas. 1

Meas. 1
Sample and diluent Sample and diluent
ISE IS ISE IS
Meas. 2

Sample and diluent Photometric assay test

ISE IS ISE IS

Meas. 2
Sample and diluent
ISE IS
Table A-5 ISE measurement sequence

For every measurement, the analyzer measures three electromotive force values
(EMF); for chloride, potassium, and sodium, where EMF denotes the difference in
potential between the respective ion-selective electrode and reference electrode.

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2 Description of the analyzer cobas c 311 analyzer
ISE area components

Finally, the results are calculated from the electromotive forces of ISE IS and diluted
sample. Table A-6 on page A-62 summarizes the flow of an ISE analysis:

Step Actor Action

Preparation of measurement
1 Reagent pipetter Pipettes ISE IS to reaction cell (450 µL(a))
2 Ultrasonic mixing unit Mixes ISE IS
3 Sample pipetter Pipettes sample (9.7 µL) to a second cell
4 Reagent pipetter Pipettes diluent (291 µL(a)) to cell with sample
5 Ultrasonic mixing unit Mixes sample and diluent
6 Reagent pipetter Pipettes ISE IS to a third cell (450 µL(a))
7 Ultrasonic mixing unit Mixes ISE IS
Internal standard (ISE IS) measurement
8 Sipper nozzle Aspirates ISE IS to Cl/K/Na cartridges (400 µL)
9 Sipper syringe Aspirates ISE Ref. to reference cartridge (65 µL)
10 Electrodes Measure ISE IS
Diluted sample measurement
11 Sipper nozzle Aspirates diluted sample to Cl/K/Na cartridges (250 µL)
12 Sipper syringe Aspirates ISE Ref. to reference cartridge (65 µL)
13 Electrodes Measure sample
If there are more samples to be analyzed, go to step 3.
Internal standard (ISE IS) measurement
14 Sipper nozzle Aspirates ISE IS to Cl/K/Na cartridges (400 µL)
15 Sipper syringe Aspirates ISE Ref. to reference cartridge (65 µL)
16 Electrodes Measure ISE IS
17 Automatic stop
Table A-6 Flow of ISE analysis
(a) For detailed information about the pipetted ISE reagent volumes, see ISE unit on page A-74.

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cobas c 311 analyzer 2 Description of the analyzer
Behind the front doors

Behind the front doors

The following figure provides a front view of the cobas c 311 analyzer. The legend lists
the main components behind the front doors of the analyzer.

F
A
B
C

G
D
H
E

A Reagent syringe F Sound volume adjustment knob

B Sample syringe G Water supply tank (deionized water)
C ISE sipper syringe H Drain tube of the vacuum tank
D Cell wash I / NaOH-D I Cooling unit (with radiator filter)
E Cell wash II / Acid Wash

Figure A-34 cobas c 311 analyzer with open front doors

Vacuum system

The vacuum system is located at the front of the analyzer. It consists of a vacuum
pump, a vacuum tank, vacuum sensors, and connecting tubing. The vacuum system
aspirates reaction mixture waste from the reaction cells to the reaction waste
container and removes reaction cell rinse water from the analyzer through the main
drain line.

Water supply

The deionized water supply system consists of the water tank, located behind the left
front door, connecting tubing, and a series of electronic valves. Water is automatically
added to the water tank when necessary. Water from this source is supplied directly to
the cell rinse unit, to the rinse stations, and to the incubator bath.
Water for the cobas c 311 analyzer is to be deionized to a conductivity of 1 µS/cm or
less. Deionized water will be consumed in about 12 L/h on average. The supply of
deionized water must have a capacity of 40 L/h or more.

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Operator’s Manual · Version 1.0 A-63
2 Description of the analyzer cobas c 311 analyzer
Behind the front doors

Sound volume adjustment knob

The sound volume adjustment knob allows adjustment of the sound volume level of
the alarm buzzer.

Auxiliary reagents and cleaning solutions

o Two bottles with detergents for the cell rinse process are located behind the left
front door of the analyzer:
O Cell Wash Solution I / NaOH-D (Cell wash I, 2000 mL)
O Cell Wash Solution II / Acid Wash (Cell wash II, 2000 mL)
e For more information, see:
To replace a cell detergent bottle on page B-109
To locate the bottles, see Figure A-34 on page A-63 (D and E).
o Two small detergent bottles (70 mL) are located close to the sample pipetter. They
are used for cleaning the sample probe.
O Position 1: Multiclean
O Position 2: SMS
e For more information, see:
To replace a sample probe detergent bottle on page B-109
To locate the bottles, see Figure A-14 on page A-36 (C).
o Two detergents for the cleaning of the reagent probe are supplied in cobas c packs:
O NaOH-D/Basic Wash
O SMS/Acid Wash
o Hitergent is supplied in a cobas c pack. Hitergent is an additive to the reaction
bath to reduce surface tension and algal proliferation.
e For more information about those reagents, see:
Auxiliary reagents and detergents on page B-100
cobas c packs on page B-101.

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cobas c 311 analyzer 2 Description of the analyzer
Rear view

Rear view

The Figure A-35 provides a rear view of the cobas c 311 analyzer. The legend lists the
main components on the back of the analyzer.

F
A
G
B
H

D I

A Cooling fan F Water supply tube for deionized water

B Power supply outlets (US only, behind cover) G ISE drain port
C Ethernet connector H Dilute waste line
D Mains connection I Waste solution container for highly
E Main circuit breaker concentrated waste
J Tray for condensation water

Figure A-35 Rear view of cobas c 311 analyzer

Power supply (US only) There are two outlets (100 V AC, 5 A) inside the cover. One is for the PC (control
unit), and the other is for the monitor only. Use these only if the power cord is too
short to reach an external power source.

The connection of PC or monitor to outlets must be done by Roche technical support only.

Ethernet connector The Ethernet connector is used for communication between the analytical unit and
the control unit.

The supplied Ethernet cable must be used. Only trained Roche technical support personnel
(or similarly qualified personnel supervised by authorized service agents of Roche
Diagnostics GmbH) are qualified to connect the Ethernet cable.

Main circuit breaker The main circuit breaker is usually turned on for keeping the reagent cooling unit
active.
e See Power switches on page A-27.

Do not place any obstacles in front of the main circuit breaker. You must have
unobstructed access at all times so that you can immediately turn off the power in case of
emergency.

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Operator’s Manual · Version 1.0 A-65
2 Description of the analyzer cobas c 311 analyzer
Rear view

ISE drain port and waste The ISE drain port is used for discharging highly concentrated waste solution from
solution container the ISE unit into the waste solution container.
The waste solution container also contains the highly concentrated waste from the
reaction cells and is equipped with a liquid level sensor for issuing an alarm when it
becomes full.

Dilute waste line This line is used for discharging dilute waste solution.

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cobas c 311 analyzer 3 Specifications
Table of contents

Specifications

This chapter gives an overview of the specifications of the cobas c 311 analyzer.

In this chapter Chapter 3

System specifications ................................................................................................ A-69
Dimensions ......................................................................................................... A-69
Operating conditions ......................................................................................... A-69
Environmental conditions ................................................................................. A-70
Control unit .............................................................................................................. A-71
Analytical unit .......................................................................................................... A-72
Reaction system .................................................................................................. A-72
Sampling system ................................................................................................. A-72
Reagent system ................................................................................................... A-73
Photometric unit ................................................................................................ A-73
ISE unit ............................................................................................................... A-74
Other specifications ................................................................................................. A-75
System interface .................................................................................................. A-75
Sample cups and tubes ....................................................................................... A-75
Barcode specifications ........................................................................................ A-76

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Table of contents

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cobas c 311 analyzer 3 Specifications
System specifications

System specifications

The following specifications apply to the cobas c 311 analyzer.

Dimensions

Dimension International (Europe) US

Depth Total 859 mm 33.8 in
Height cobas c 311 analyzer 1260 mm 49.6 in
Top height level of the monitor 1380-1570 mm 54.3-61.8 in
is adjustable approx. between
Length Total 1325 mm 52.2 in
Weight Analytical unit about 250 kg 551 lb
Control unit about 20 kg 44 lb
Table A-7 Dimensions of the cobas c 311 analyzer

Operating conditions

The power distribution panel and the water supply and drainage facilities must be
available within 5 m of the analyzer.

Electric power supply Power rating Single phase/230 V AC/50 Hz (international/Europe) or

208 V AC/60 Hz (US/Canada)
Power supply fluctuation No significant power supply fluctuation (operating on
208/230 V AC, max. power supply change: ± 10 %)
Overvoltage category II
Pollution degree 2
Power consumption 1.5 kVA for analytical unit, 0.5 kVA for control unit
Electrical installation Technical standard class C
Required earthing < 10 Ω
Bonding impedance < 0.1 Ω at 30 A
Insulation resistance >10 MΩ at 500 V

Electrical shock by electronic equipment

o The power supply must be grounded.
WARNING o The analyzer must only be connected to a power supply source with the specified
power supply cable and only by authorized personnel.

Incorrect results due to improper grounding of the electrical installations within a

building
CAUTION If grounding is poor, external noise will have a greater influence on the instrument.
o Comply with the specifications for electrical installation.

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Operator’s Manual · Version 1.0 A-69
3 Specifications cobas c 311 analyzer
System specifications

Water requirements Bacteria-free, deionized water < 10 cfu/mL

Conductivity 1.0 µS/cm or less (1.5 MΩ resistance)
Water pressure 50-340 kPa (0.5-3.4 kg/cm2)
Water consumption 12 L/h during operation
Required water supply 40 L/h

Environmental conditions

The following environmental conditions must be followed in order to ensure correct

operation of the analyzer:

Ambient temperature During operation:

o 15 to 32°C (64.4-89.6°F)
with changes < ± 2°C (± 3.6°F) during analysis
During transportation and storage:
o -20 to 75°C (-4 to 167°F)
Ambient humidity During operation:
o 45-85% (non-condensing)
During transportation and storage:
o 5-95%
Altitude up to 2000 m
Electromagnetic interference o No equipment generating electromagnetic waves in
the near vicinity (e.g., cell phones, transceivers,
cordless phones, etc.)
o No machines discharging ultrahigh frequencies (e.g.,
electric discharger)
Noise emission < 65 dB(A) for surrounding
Other environmental conditions o Dust-free environment with adequate ventilation
o No direct sunlight
o No perceptible vibration
o Indoor use only
Floor condition Level (angle: less than 1/200); strong enough to hold the
weight of the instrument, see Dimensions on page A-69.

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A-70 Operator’s Manual · Version 1.0
cobas c 311 analyzer 3 Specifications
Control unit

Control unit

The following specifications apply to the control unit of the cobas c 311 analyzer.

PC Supplied by Roche/Hitachi according to instrument

requirements
DVD drive 4.7 GB capacity
Applicable data media DVD-R, DVD+R, DVD-RW,
DVD+RW
Monitor 17" LCD color monitor with touch screen system
Keyboard 101-key enhanced, country-specific
Monitor and keyboard base Height adjustable

Data storage Sample data (routine/STAT) 10 000 samples (routine, STAT and quality control
samples)
Reaction process data 10 000 tests (routine, STAT and quality control samples)
Quality control data Individual: 2500 samples, 100 tests/sample
Cumulative: 100 tests, 500 points/test

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Operator’s Manual · Version 1.0 A-71
3 Specifications cobas c 311 analyzer
Analytical unit

Analytical unit

The following specifications apply to the analytical unit of the cobas c 311 analyzer.

Reaction system

Applications Up to 100 applications:

o 86 photometric applications
o 3 electrolyte applications
o 8 calculated tests
o 3 serum indices
Number of cobas c packs Up to 42
on board
Throughput Up to 300 tests/h
Reaction volume 100-250 µL
Reaction temperature 37 ± 0.1°C circulating incubator bath
Reaction disk Turntable system with 66 reaction cells
Reaction cells 6 segments of 11 reaction cells each (semi-disposable
cuvettes for photometry)
Reaction times 3-10 min, in 1-minute steps
Pipetting cycle 12 s
System start-up time 6 min (power on to standby)(a)
Mixing method Non-contact ultrasonic mixing (15 levels)

(a) If no Power Up Pipe function has been programmed to occur.

Processing capacity varies depending on measuring conditions, test selection and system
configuration

Sampling system

Sample types Serum/plasma, urine, CSF, supernatant, other

Sample pipetting volume 1.0-35 µL, in 0.1 µL increments
1.0-1.9 µL – water extrusion (15 µL)
2.0-35 µL – sample dummy (10 µL)
20.1-35 µL – two cycles used (24 s)
Detection of sample clogging Pressure sensitive clot detection system
Liquid level sensor Capacitance sensing technology

e For information about the minimum sample volume, see:

Sample cups and tubes on page A-75

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Analytical unit

Reagent system

Reagent identification Barcode identification, manual placement

Reagent pipetting volume 5-180 µL, in 1 µL increments (5-19 µL: + 20 µL water)
Reagent pipetting timing 3 timings possible (R1: 0 min; R2: 1.5 min; R3: 5 min)
Reagent storage Refrigerated compartment for up to 42 cobas c packs
Reagents 4 different configurations available with up to 3 reagent
bottles/cassette:
o cobas c packs: bottles of 20 mL, 40 mL, or 60 mL:
(20/40/20 mL, 40/40 mL, 60/20 mL)
o COBAS INTEGRA cassette: Pos. A: 22.6 mL, Pos. B/C:
11.0 mL
Reagent cooling 5-15°C
Remaining reagent volume Automatic test countdown with each pipetting
control

e For information about the reagents used on the analyzer, see:

Reagent concept on page B-97

Photometric unit

Light source Tungsten halogen lamp, 12 V / 50 W

Photometer Multiple wavelength spectrophotometer
Wavelengths 12 wavelengths available: 340, 376, 415, 450, 480, 505, 546,
570, 600, 660, 700, 800 ± 2 nm
Optical path length 5.6 mm
Optical range 0.0000-3.0000 absorbance
Linearity Up to 2.5 absorbance
Optical mode Monochromatic and bichromatic

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3 Specifications cobas c 311 analyzer
Analytical unit

ISE unit

Applications Na+, K+, Cl– in serum and urine

Detection system Ion-selective electrode system
Throughput 150 samples/h (corresponding to 450 tests/h)
Sample pipetting volume 9.7 µL (6.5 µL for urine manual rerun only)
Reagent consumption ISE Dil. 355 µL/sample (dilution to 1/31)
ISE IS 710 µL/sample (measurements in succession)
1420 µL/sample (single measurement)
ISE Ref. 130 µL/sample (measurements in succession)
(KCl) 195 µL/sample (single measurement)
Measuring range (serum) Na+ 80-180 mmol/L
K+ 1.5-10.0 mmol/L
-
Cl 60-140 mmol/L
Measuring range (urine) Na+ 10-250 mmol/L
+
K 1-100 mmol/L
Cl- 10-250 mmol/L
Measuring temperature 37° ± 2°C (during operation ± 0.5°C)
Cycle time 24 s
Liquid level sensor Capacitance sensing technology
Mixing method Non-contact ultrasonic mixing
Bottle volume ISE IS 600 mL
ISE Dil. 300 mL
ISE Ref. 300 mL

Reagent pipetting volumes Volume ISE IS ISE Dil. ISE Ref.

during analysis Aspirated from reagent bottle 710 µL 355 µL –
(a)
Discharged to reaction cell 450 µL 291 µL –
Aspirated by the ISE sipper 400 µL 250 µL(b) 65 µL
Table A-8 Reagent pipetting volumes during analysis
(a) The discharged volumes are lower because of the required dummy volume of the reagent pipetter.
(b) Diluted sample. Dilution ratio 1:31

e For a description of an ISE analysis flow, see:

Flow of ISE analysis on page A-62.

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cobas c 311 analyzer 3 Specifications
Other specifications

Other specifications

In addition to specifications of the control unit and the analytical unit themselves,
this section provides an overview of specifications of the system interface, barcodes,
and sample containers.

System interface

The instrument can be bidirectionally interfaced with a Host.

System interface RS-232C serial interface

e For information about the serial interface, refer to the Host Interface Manual.

All data processing equipment connected to the system must comply with the relevant
standards (IEC 950, UL 1950, CSA 22.2 No. 950).

Sample cups and tubes

Sample cups (both standard and micro cups) can be inserted into sample tubes with
16 mm diameter (cup on tube) or they can be used without tubes.

Container Diameter × length Minimum sample

volume (dead volume)
Primary sample tube 16 mm × 100 mm 1000 µL
Primary sample tube 16 mm × 75 mm 1000 µL
Primary sample tube 13 mm × 100 mm 500 µL
13 mm × 75 mm 500 µL
Hitachi standard cup 17 mm × 38 mm, 2.5 mL 100 µL
(a) 100 µL(b)
Hitachi micro cup 8 mm × 37 mm, 1.5 mL
Roche false bottom tube(c) 13 mm × 75 mm 70 µL
Freely definable type of 12-16 mm × 75-100 mm
false bottom tube /
non-standard tube(c)
Table A-9 Sample containers
(a) Not applicable to calibrators and QCs
(b) A dead volume of 50 µL is available if the Hitachi micro cup is directly loaded on the sample disk (not
as a cup on tube) and the sample cup size is set to Micro on the Workplace > Test Selection screen.
(c) Only one type of false bottom / non-standard tube can be used on the analyzer at the same time.

Avoid overfilling sample tubes and cups

Leave approx. 10 mm clearance between the liquid and the top of the tube or cup.

e For a figure of sample cups and tubes, see

Sample containers on page A-41.

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Operator’s Manual · Version 1.0 A-75
3 Specifications cobas c 311 analyzer
Other specifications

Barcode specifications

Barcodes used with the cobas c 311 analyzer must be in compliance with one of the
following standards:
o NW7 (Codabar)
o Code 39
o ITF
o Code 128

Incorrect results due to undetected scanning errors

Barcode scanning errors could potentially go undetected when a check digit is not used.
CAUTION o Use only barcodes with check digits.
o Use only barcode labels of a good printout quality.

Sample barcodes The following specifications apply to the various barcode types:

Reading method Scanning with CCD sensor

Used barcode symbol NW7 (Codabar), Code 39, ITF, Code 128
Check digit Must be used to prevent scanning errors.
Number of ID digits NW7 2-22 digits + 1 digit (with check digit)
Code 39 2-22 digits + 1 digit (with check digit)
ITF 3-21 digits + 1 digit (with check digit)
Code 128 3-22 digits + 2 digits (with check digit)
Characters usable for ID NW7 o 0 to 9 (without check digit)
o 0 to 9, -, /, ., , $, :, + (with check digit)
Code 39 0 to 9, A to Z, -, ., [ ], /, +, $, %
ITF 0 to 9
Code 128 Alphanumerics (excluding those assigned to
functions and communications)
Check digit NW7 Modulus 16, Modulus 11, Modulus 10/2 weight,
Modulus 10/3 weight, 7 check DR, weighted
Modulus 11
Code 39 Modulus 43
ITF Modulus 10/3 weight
Code 128 Modulus 103

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cobas c 311 analyzer 3 Specifications
Other specifications

Scan range for sample barcodes Stick the label in exact alignment with the centerline of the sample tube in order to
prevent scanning errors.

100 mm 75 mm
sample tube sample tube

Scan range
88 mm

Figure A-36 Scan range of sample barcode reader

Specifications of barcode labels Secure a margin of 5 mm or more on each edge of barcode label.

≤ 66 mm for 100 mm sample tubes

≤ 53 mm for 75 mm sample tubes

Figure A-37 Specifications of barcode labels

Bar and space Minimum bar (space) width 0.19 up to 0.20 mm

Ratio of narrow bar (space) to wide bar 1 : 2.5 to 3
(space)
Reflectance and Space reflectance ≥ 75%
PCS value PCS value ≥ 0.7
Colors Bar black
Space white
Other Bar print must not be blurred.
Label indications must not be contaminated.

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Operator’s Manual · Version 1.0 A-77
3 Specifications cobas c 311 analyzer
Other specifications

Roche Diagnostics
A-78 Operator’s Manual · Version 1.0
 Operation B

4 Safety information for operation . . . . . . . . . . . . . . . . . . . . . . . . B-3

5 Software basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5
6 Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-27
7 Orders and results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-75
8 Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-95
9 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-115
10 QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-141
11 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-171
cobas c 311 analyzer 4 Safety information for operation

Safety information for operation

Make sure that you have read and understood the chapter General safety information. The
following safety messages in particular are relevant:
Warning messages:
o Electrical shock by electronic equipment on page A-8
o Infection by samples and associated materials on page A-8
o Infection and injury due to sharp objects on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9
o Infection by waste solution on page A-9
o Contamination of the environment by waste solution and solid waste on page A-9
Caution messages:
o Personal injury due to contact with moving parts on page A-10
o Incorrect results due to incorrect reagent volume on page A-10
o Incorrect results and interruption of analysis due to contaminated samples on page A-10
o Incorrect results due to evaporation of samples or reagents on page A-11
o Incorrect results due to carryover on page A-11
o Fatigue due to long hours of operation on page A-11
o Spillage on page A-11
Observe the system safety labels illustrated and described starting on page A-13.

Before starting to work with the analyzer, read the following safety messages carefully.
If you ignore these safety messages, you may suffer serious or fatal injury.

Infection and injury due to contact with instrument mechanism

Contact with the sampling mechanism or other mechanisms may result in personal injury
WARNING and infection.
o Whenever possible, keep the top cover and the front cover of the analytical unit closed.
o When working with open top cover while the instrument is powered on (e.g., for
replacement of ISE reagents), always put the analyzer in Maintenance mode or in
Shutdown status first.
o Do not open the top cover while the analyzer is operating.
o Do not touch any parts of the instrument other than those specified.
o Observe all instructions given in this manual very carefully.

Infection due to contact with splashes of reaction solution or by inhaling reaction

solution aerosol from the ultrasonic mixer
Keep the top cover closed and in place while the instrument is operating.

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Operator’s Manual · Version 1.0 B-3
4 Safety information for operation cobas c 311 analyzer

Incorrect results due to position mismatch

o Be sure to load samples and reagents only into the specified positions on the
CAUTION instrument.
o When operating in non-barcode mode, make sure to load the samples according to the
Requisition list provided by the analyzer.

Incorrect results due to expired reagents or mixing reagents

Data obtained using expired reagents are not reliable. Mixing together new reagent and
residues of old reagent may also lead to incorrect results.
o Do not use reagents that have exceeded their expiration dates.
o Do not top off old reagent with new reagent. When a bottle is empty, replace it with a
new one.

Incorrect results due to missing covers of the ISE unit

If the cover of the ISE measuring compartment or the cover of the sipper nozzle are not
reinstalled after maintenance, the temperature level or the noise level may be affected,
leading to incorrect results. Touching any ISE component or opening the front doors may
also affect the noise level and lower measurement precision.
o Only perform measurement, if the covers of the ISE unit are installed.
o Do not open the front doors during measurement.
o Do not touch the ISE Ref. tube, the ISE unit, or the sipper nozzle cover during
measurement.

Incorrect results due to aspiration of air

Incorrect pipetting of the probes as well as incorrect adjustment of the probe position may
result in aspiration of air, leading to incorrect results.
o Check the instrument performance by performing control measurements.
o Perform maintenance procedures regularly.

Incorrect results due to incorrect mixing volume

The permissible volume of reaction solution to be mixed by the ultrasonic mixer is 100 to
250 µL. If the volume is outside this range, the reaction solution may not be mixed
correctly, leading to incorrect results.
o Make sure that the volume of reaction solution stays in the range of 100 to 250 µL,
especially when loading a new application onto the analyzer.
o For information on analytical parameters of each reagent, contact its manufacturer.

Roche Diagnostics
B-4 Operator’s Manual · Version 1.0
cobas c 311 analyzer 5 Software basics
Table of contents

Software basics

This chapter is an introduction to the basic operational procedures for the

cobas c 311 analyzer.

In this chapter Chapter 5

General description of the user interface .................................................................. B-7
Fixed areas .................................................................................................................. B-8
Status line .............................................................................................................. B-8
Help button and guidance prompt ...................................................................... B-9
Global buttons .................................................................................................... B-10
Main menus .............................................................................................................. B-11
System Overview ................................................................................................ B-11
Workplace ........................................................................................................... B-12
Reagent ................................................................................................................ B-13
Calibration .......................................................................................................... B-14
QC ....................................................................................................................... B-15
Utility .................................................................................................................. B-16
Software elements ..................................................................................................... B-17
Menus, screens and tabs ..................................................................................... B-17
Buttons ................................................................................................................ B-18
Buttons with black triangles and gray buttons ........................................... B-19
Standard buttons .......................................................................................... B-19
List boxes ............................................................................................................. B-20
Text boxes ............................................................................................................ B-20
Check boxes ........................................................................................................ B-21
Options ............................................................................................................... B-22
Windows ............................................................................................................. B-22
Online Help system .................................................................................................. B-23
Shortcut keys ............................................................................................................ B-24

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Operator’s Manual · Version 1.0 B-5
5 Software basics cobas c 311 analyzer
Table of contents

Roche Diagnostics
B-6 Operator’s Manual · Version 1.0
cobas c 311 analyzer 5 Software basics
General description of the user interface

General description of the user interface

The screen representations shown in this chapter and throughout this manual are for
illustrative purposes only. The screens do not necessarily show valid results.

The screen of the analyzer software is divided into four different areas. Following is an
example of a screen showing the different areas.

A Status line C Global buttons

B Menu area D Help button and guidance prompt

Figure B-1 Screen configuration

Fixed areas The three outer areas are fixed and accessible from every screen:
o The status line provides information about the current status.
o The help button and the guidance prompt provide support that is specific to the
current menu and the location of the cursor.
o The global buttons provide access to specific functions.
e See Fixed areas on page B-8
See Online Help system on page B-23

Menu area The menu area in the center changes according to the currently active menu or
function. Standard software elements like buttons, menu tabs, windows, etc. are used
in the menus. If you are not familiar with these elements, we recommend that you
read the section Software elements first.
e See Main menus on page B-11
See Software elements on page B-17

The software can be operated by touchscreen, mouse or keyboard.

e For information about operation with the keyboard, see
Shortcut keys on page B-24.

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Operator’s Manual · Version 1.0 B-7
5 Software basics cobas c 311 analyzer
Fixed areas

Fixed areas

This section discusses the three areas that appear at the top, the lower left and the
right side of each screen.

Status line

The status line appears across the top of each screen.

A BC D E F

A Status icon for the host E Operator ID (logon name)

B Status icon for the core unit F Current date and time
C Status icon for the analytical unit
D Operational mode of the analyzer

Figure B-2 Status line

The status line displays the current status of the units, operational mode, operator ID,
date and time, and the time remaining when performing maintenance.

Status icons The three status icons on the left display the current statuses of the units:

o Host: external system. This icon is only visible if the host communication is
enabled in the Start Conditions window.
o Core unit, e.g. power supply and water supply
o Analytical unit (AU)

Call up the System Overview screen from any other screen

Touching one of the status icons on any screen will display the System Overview screen.
The System Overview screen provides information about the selected unit.

Status colors The status colors represent the operational mode and additional information of each
unit or component. The following describes the status colors from the highest to the
lowest priority:

Color Meaning
Red Indicates an instrument alarm at the Stop, S.Stop or E.Stop level
or that a reagent is empty and there is no second cobas c pack
placed on this analyzer.
Yellow Indicates an instrument alarm at a caution level or that the
number of remaining tests is below the yellow alarm level
threshold.(a)
Purple Indicates that the number of tests remaining for a diluent, test
reagent or detergent volume is less than the daily requirement(a) -
only applicable if the Preventive Action check box has been
selected.
Table B-1 Color scheme of the status icons for each unit (Sheet 1 of 2)
(a) Specified on the Utility > System (Page 2/5) > Reagent Level Check window.
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Fixed areas

Color Meaning
Light blue Indicates a status other than Standby (e.g., Operation or
Maintenance).
Light green Indicates Standby mode.
Table B-1 Color scheme of the status icons for each unit (Sheet 2 of 2)
(a) Specified on the Utility > System (Page 2/5) > Reagent Level Check window.

Screen accessibility
Some screens are not accessible with the operator level logon, or can be viewed with a
supervisor level logon but not edited. Some fields are viewed only at the administrator level
logon.

Help button and guidance prompt

The help button and the guidance prompt are shown in the lower left of each screen.

A B

A Help button B Guidance prompt

Figure B-3 Help button and guidance prompt

Help button The Help button displays context-sensitive help.

e For information about using the Help button, see
Online Help system on page B-23.

Guidance prompt In this area, the software prompts you as to what kind of information to type and
what format to use when typing that information. The guidance prompt may also tell
what action to take, such as touching a button or pressing a key. For example, “Touch
screen or press <Enter>”. Each prompt is specific to the location of the cursor.

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Fixed areas

Global buttons

Use the global buttons to display screens that are used for specific functions. The
global buttons are accessible from every screen and appear on the right side of the
screen.

Figure B-4 Global buttons

The global buttons include the following functions:

Global button Function

Stop To stop operation, e.g. a running analysis or maintenance
procedure. All results currently being processed will be lost.
Shut down o To log-off the operator
o To put the analyzer in Sleep mode
o To shut down the analyzer
S. Stop To stop sampling.
Alarm To display the alarm list and the countermeasures. If an alarm was
issued, the Alarm global button flashes yellow or red.
Print To print information, e.g. the requisition list, calibration and QC
results, or patient reports.
Pause/Scan o To pause the sample disk, e.g. to add samples on the disk
o To scan sample cups before analysis. The sample disk rotates
and checks if a position on the sample disk is occupied.
Start To select start conditions and to start analysis.
Table B-2 Functions of the global buttons

The Stop, S. Stop and Start buttons are also the system control buttons. The global
buttons can be selected by touchscreen, mouse or keyboard.
e For information about operation with the keyboard, see
Shortcut keys on page B-24.

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Main menus

Main menus

The graphical user interface used by the control unit consists of the System Overview
screen and 5 main menus, Workplace, Reagent, Calibration, QC and Utility. Each
menu consists of two or more screens. Through these screens all instrument functions
are controlled.
Access to some screens, especially those of the Utility menu, is confined to the access
level of the user. For this reason, the screen may not appear exactly as shown here.
Standard software elements like buttons, menu tabs, windows, etc. are used in the
menus. If you are not familiar with these elements, we recommend that you read the
section Software elements first.
e See Software elements on page B-17

System Overview

The System Overview screen has a central role within the cobas c 311 analyzer
software. This screen provides an overview of the whole system at any given time. It
displays the status of each completed sample, and the analyzer can be prepared for
daily routine operation.

A Work Flow Guide, guides you through the preroutine operation

B Overview area, provides information about the selected unit
C Print View button, displays a preview of current data
D Buttons to open the main menus

Figure B-5 System Overview screen

e For more information, see:

System Overview screen on page B-36

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Main menus

Workplace

The Workplace menu consists of 2 screens: Test Selection and Data Review.
The Test Selection screen is used to perform the following:
o To make test selections
o To specify patient demographics
o To assign patient ID numbers and disk positions to samples
The Data Review screen is used to perform the following:
o To review data
o To backup data
o To edit data
o To delete data
o To send data to the Host

Figure B-6 Workplace menu

e For more information, see:

Test Selection screen on page B-78
Data Review screen on page B-88

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Main menus

Reagent

The Reagent menu consists of 2 screens: Setting and Status. These screens are used to
view detailed reagent information and to load and unload reagents.

Figure B-7 Reagent menu

e For more information, see:

Reagent Setting screen on page B-107
Reagent Status screen on page B-108

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Main menus

Calibration

The Calibration menu consists of 3 screens: Status, Calibrator and Install. These
screens are used to request calibrations, define calibrators and view the reaction
curves for calibrators installed on the system. The calibration mode for the next start
up calibration or for an intermediate calibration can be determined from here. If an
intermediate calibration is necessary, it can be requested by test and calibration type.

Figure B-8 Calibration menu

e For more information, see:

Calibration Status screen on page B-122
Calibration Install screen on page B-131
Calibration Calibrator screen on page B-137

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Main menus

QC

The QC menu consists of 6 screens: Status, Run Status, Individual, Cumulative,

Control, and Install. Use these screens to install, view and edit controls, and to
evaluate, accumulate and print quality control results.

Figure B-9 QC menu

e For more information, see:

QC Status screen on page B-146
QC Run Status screen on page B-150
QC Individual screen on page B-152
QC Cumulative screen on page B-160
QC Control screen on page B-162
QC Install screen on page B-164

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Main menus

Utility

The Utility menu consists of 7 screens: System, Maintenance, Application, Calculated

Test, Special Wash, Report Format, and Module Set. These screens are used to enter
system parameters, application parameters, maintenance settings and system settings.

A Page button

Figure B-10 Utility menu

Page buttons The Utility > System screen displays page buttons that can be used to display
additional buttons to display new screens. These page buttons are numbered (X/5), to
indicate which page you are on.

The page buttons only change the displayed buttons and not the entire appearance of the
screen.

e For more information, see:

System configuration on page B-191
Performing maintenance items on page C-9
Application on page B-173
Calculated Tests on page B-204
Special Wash on page B-209
Report Format on page B-214
Module Set on page B-202

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Software elements

Software elements

These elements are used to navigate through the software, to select a choice or
function, and to type in information.

Menus, screens and tabs

The menu tabs are displayed below the status line.

A
B
C

A A tab
B Menu tabs
C Screen tabs (for submenus)
D A screen (the Utility > System screen)

Figure B-11 Menus, screens and tabs

Menus The menu tabs are used to select screens and windows that are grouped together and
perform related tasks. The menu tabs are accessible from every screen, except the
global screens. This makes the software navigation within the menus and between
menus very easy.
The menu tabs are only for the 5 menus: Workplace, Reagent, Calibration, QC and
Utility. The menu tabs can be selected by touchscreen, mouse or keyboard. The
selected menu is colored blue.

Screens Each menu contains of two or more screens. Screens are frequently also called
submenus. The example asks you to select the Utility menu and therein the System
screen.
Example: Choose the Utility > System screen.

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Software elements

Tabs Tab is the common name for a special kind of button, with which you can switch
between menus.

Menus

Screens

A Tabs(a)

A The Calib. tab in the Utility > Application screen (cutout)

Figure B-12 Example of a tab and the hierarchical structure of menus, screens and tabs
(a) Tabs appear only in the Utility > Application screen, in the Workplace > Test selection screen, in a few
windows and a few global menus.

In this document, the term tab is mostly used as a generic term for subscreens or
subwindows. Subscreens appear in two screens (see Figure B-12) and a few windows
and global menus use subwindows (see Figure B-13, C).
Example: Choose the Calib. tab on the Utility > Application screen.
This is equal to: Choose the Utility > Application > Calib. screen.

Buttons

Buttons are used for execution of functions, confirmation of entries and selections,
and displaying pop-up windows. The available buttons depend on the menu or screen
that is active.

B D

A Normal button C Utility tab of the Print menu

B Button that displays another window (black D Button that performs the function and closes
triangle in the upper right corner) the window (black triangle in the lower left
corner)

Figure B-13 Examples of buttons

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Software elements

There are several ways to choose a button:

1. Touchscreen: Choose a button by touching it on the screen.
2. Keyboard: Press the <Arrow> keys or the <Tab> key to highlight a button. Press
the <Enter> key to initiate the action.

Buttons with black triangles and gray buttons

Black triangle The black triangle in the upper right corner of a button indicates that touching this
button displays another window (see Figure B-13, B).
The black triangle in the lower left corner of a button indicates that touching this
button performs the specified function and closes the window (see Figure B-13, D).

Text color on buttons If the text on the button is black, the button is available in the current mode. If the
text on the button is gray, the button is not available in the current mode.

Standard buttons
The following buttons are used throughout the software. These buttons are explained
below and will not be explained again with each individual screen.

OK Touch this button to accept the changes and entries made on a window and to close
the window.

Cancel Touch this button to close the window without saving the changes and entries made
on a window.

Yes Touch this button to accept the changes made on a window, execute the action of the
window (e.g., Delete) and close the window.

No Touch this button to close the window without saving the changes made on a window
or without executing the function of the window (e.g., Delete).

Close Touch this button to close the window.

Save Touch this button to save any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.

Update Touch this button to update any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.

Execute Touch this button to accept the changes made on a window, to execute the action of
the window and to close the window.

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Software elements

List boxes

List boxes display a list of choices. If there are more choices than can fit in the box, a
scroll bar is displayed. List box is a generic term for any type of dialog box option
containing a list of items the user can select.

A Open list box B Pull-down list box

C Pull-down list box currently not available

Figure B-14 Examples of list boxes

To select an item in a list box:

1. Touchscreen: Touch the desired area within the list box on the screen. If a scroll
bar is displayed next to the list box, touch the scroll bar above or below the current
display position, or touch the arrows on the scroll bar to move up or down the list.
2. Keyboard: The <Arrow> keys can be used to move quickly through the list. Press
the <Arrow> key that points in the direction you want to move. The currently
selected choice is indicated by the selection cursor, which appears as a highlight.
The Home, End, Page Up and Page Down keys can also be used to move through
the list. When the desired item is highlighted, press <Enter>.

Text boxes

Text boxes are used to type information. When you move to an empty text box, the
box is highlighted.

Figure B-15 Example of a text box

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Software elements

To type in information in a text box:

1. Touchscreen: Move to a text box by touching it on the screen. The text box
highlights when you touch it.
2. Keyboard: Move to a text box by pressing the <Tab> key. The text box highlights
when you move to it.
Press the <Enter> key to accept information typed. The cursor then moves to the next
field.

Check boxes

Check boxes are used to select a particular function. Sometimes when an option is
selected, additional fields become available. Multiple check boxes can be selected in
the same area of the screen.
es

Figure B-16 Example of a check box

To select a check box:

1. Touchscreen: Move to the check box by touching it on the screen. A check mark
appears in the check box when it is selected. When the check box is blank, it is not
selected.
2. Keyboard: Move to the check box by pressing the <Tab> key. If multiple check
boxes are available, the up and down arrow keys move to the different check boxes.

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Software elements

Options

Options are used to select a particular function. Sometimes when an option is

selected, other fields become available.

Figure B-17 Example of options

An option is selected when a black circle is displayed within the white circle for the
option. Only one option can be selected at a time.
1. Touchscreen: Move to the option by touching it on the screen. The option displays
a black circle within the white circle when you touch the option.
2. Keyboard: Move to the option by pressing the <Tab> key. If multiple options are
available, the up and down arrow keys move to the different options.

Windows

Windows contain additional information that pops up over existing screens.

Figure B-18 Example of a window

Windows function similar to screens. Information on a window can be entered or

edited through list boxes, text boxes, options, check boxes and action buttons.

Confirmation Window Many functions require confirmation prior to their execution (e.g., Delete).
Confirmation windows are used to confirm these functions. Touch Yes to confirm the
function and to close the confirmation window, or touch No to close the
confirmation window without carrying out the function.

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Online Help system

Online Help system

The cobas c 311 analyzer has a context-sensitive online Help feature to aid in
operating the analyzer. “context-sensitive” means that wherever you are located
within the cobas c 311 software, choosing the Help feature displays information
relating to your current location in the software. The online Help offers a quick and
convenient way to find information, such as explanations of screens and dialog boxes
and how to perform particular processes.

A
A F1 Help

Figure B-19 Online Help button

F1 Help There are two ways to enter the online Help: via the Help icon in the bottom left of the
screen or by pressing F1 on the keyboard. The context-sensitive entry displays
information relating to your current location in the software.

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Shortcut keys

Shortcut keys

All functions can be initiated via the keyboard or the touchscreen for selection of
screen items.
All special keys and their functions are described below.

Shortcut Description
<F1> Use this key to display the Online Help.
<F2> Use this key to display the Start Conditions screen.
<F3> Use this key to display the Sample Stop screen.
<F4> Use this key to display the Stop screen.
<F5> Use this key to display the Workplace menu. This key does not
work if you are in a global screen.
<F6> Use this key to display the Reagent menu. This key does not
work if you are in a global screen.
<F7> Use this key to display the Calibration menu. This key does not
work if you are in a global screen.
<F8> Use this key to display the QC menu. This key does not work if
you are in a global screen.
<F9> Use this key to display the Utility menu. This key does not work
if you are in a global screen.
<F10> Use this key to display the Sample Pause/Scan screen.
<F11> Use this key to display the Alarm screen.
<F12> Use this key to display the System Overview screen.
<Print/Print Screen> Use this key to display the Print screen. Press <Shift + Print
Screen> simultaneously to print the current screen.
<Scroll Lock> Use this key to display the Cancel Print window.
<Pause/Break> Use this key to display the Shutdown screen with the options
Logoff, Sleep and Shutdown.
<Esc> Use this key to exit a window or global screen.
<Tab> Use this key to move to the next field in a window or screen. To
go from a field to the previous one, press <Shift + Tab>
simultaneously.
<Enter> Use this key to confirm an entry.
<Shift> Simultaneously pressing <Shift> and a character key generates
a capital letter or a special character, for example on an English
keyboard <Shift + ,> generates the character “<”.
<Backspace> Use this key to delete a character to the left of the cursor.
<Space> Use this key to generate a space.
<Delete> Use this key to delete a character to the right of the cursor.
<Home> Use this key to place the cursor at the beginning of a list or text
box.
<End> Use this key to place the cursor at the end of a list.
<Page Up> Use this key to scroll upward in a list, one page at a time.
<Page Down> Use this key to scroll downward in a list, one page at a time.
Table B-3 Shortcut keys (Sheet 1 of 2)

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Shortcut keys

Shortcut Description
<Arrow> Use these keys to move the cursor to the right, left, upwards or
downwards within a text box.
<Caps Lock> Use this key to lock the letter keys into the upper case mode.
<Num Lock> Use this key to activate the numerical keypad for entering
numbers and mathematical operators such as +, -, /, *.
Table B-3 Shortcut keys (Sheet 2 of 2)

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Shortcut keys

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cobas c 311 analyzer 6 Daily operation
Table of contents

Daily operation

This chapter provides a description of the everyday tasks which are required for
running the cobas c 311 analyzer. Common procedures that are performed as part of
the daily workflow are also described here.

In this chapter Chapter 6

Overview ................................................................................................................... B-29
Starting the analyzer ................................................................................................. B-30
Start-up inspection ............................................................................................. B-30
Instrument statuses ............................................................................................ B-32
Maintenance mode ....................................................................................... B-33
Check system alarms .......................................................................................... B-35
System Overview screen ..................................................................................... B-36
Color scheme of the System Overview screen ............................................. B-37
Work Flow Guide .......................................................................................... B-39
Preventive action .......................................................................................... B-39
Preroutine operation ................................................................................................ B-40
Daily Maintenance button ................................................................................. B-40
Sample Data Clear button .................................................................................. B-41
Reagent Preparing button .................................................................................. B-42
ISE reagents ................................................................................................... B-42
Loading cobas c packs .................................................................................. B-45
Unloading cobas c packs .............................................................................. B-47
Calibration And QC Select button .................................................................... B-48
Requesting calibration and QC and printing load lists .............................. B-48
Measuring calibrators and controls ............................................................. B-52
Validating calibration and QC results ......................................................... B-53
Parameter Download button ............................................................................. B-54
Sample Tracking button ..................................................................................... B-55
Routine Operation ................................................................................................... B-56
Processing routine samples ................................................................................ B-57
Test selection ................................................................................................. B-57
Loading routine samples .............................................................................. B-57
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Table of contents

Starting the measurement ............................................................................ B-58

Processing additional samples ..................................................................... B-59
Interruption of measurements ..................................................................... B-60
Processing STAT samples ................................................................................... B-61
Test selection ................................................................................................. B-61
Loading STAT samples ................................................................................. B-61
Processing reruns ................................................................................................ B-62
Automatic reruns .......................................................................................... B-62
Manual reruns .............................................................................................. B-63
Reruns with changed sample volumes ........................................................ B-64
Prediluted samples ........................................................................................ B-64
Checking results and handling of data .............................................................. B-65
Sample tracking ............................................................................................ B-66
Archiving data and performing data backups ............................................ B-68
Printing sample information ....................................................................... B-69
Sampling Stop ..................................................................................................... B-70
Shutting down the analyzer ..................................................................................... B-71
Maintenance before shutdown .......................................................................... B-71
Analyzer shutdown and sleep mode .................................................................. B-71
Checks after shutdown ....................................................................................... B-73

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Table of contents

Overview

Daily operation Daily operation encompasses the routine tasks that are required to prepare and
maintain the analyzer, and to analyze samples. The layout of the System Overview
screen provides the operator with an intuitive guide to the tasks required for routine
operation.
The following diagram gives an overview of daily operation.

Starting inspection

Analyzer start-up
(Initialization and standby)
• Check Alarm button

Preroutine operation
• Preventive action
• Calibration and QC

Routine operation
• Routine or STAT sampling Rerun assigned
------------------------------------------------------
Results

Stop and standby

Maintenance

Shutdown

Figure B-20 Workflow diagram

Certain maintenance items must be performed every day before the start of analysis.
We recommend performing the Power ON pipe every day during the Power ON procedure.

e For detailed information see:

Daily maintenance on page C-40
Power ON pipe on page C-16.

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Table of contents

Starting the analyzer

Before you can start routine operation, you must first prepare the analyzer for
operation.

Start-up inspection

Before start-up, it is important to check that all of the following conditions are met. If
a condition is not met, take the necessary remedial action.

Before performing the following actions, observe the following safety precautions:
o Infection by samples and associated materials on page A-8
o Infection by waste solution on page A-9
o Personal injury due to contact with moving parts on page A-10
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

o Before starting the instrument, always check that:

Check that: Page

Control unit There is no floppy disk in drive A.
There is sufficient paper in the printer.
Analyzer The water supply is switched on. A-65
The container for highly concentrated waste is clean and A-65
empty, and placed in the correct position.
All connections and fittings of tubes and containers are
connected properly and are not leaking.
The cell covers are free of contamination. If necessary, clean C-53
the cell covers using a gauze pad moistened with 70%
ethanol.
There is enough volume in the auxiliary reagent bottles and B-42
ISE reagents.
e See also: ISE area components on page A-58
Auxiliary reagents and detergents on page B-100
The sample probe, reagent probe, sipper nozzle and rinse C-44
nozzles are clean. In case cleaning is necessary, take the C-47
appropriate maintenance actions described.
No liquid is leaking inside the ISE compartment and the C-82
electrode wires are connected properly.
Table B-4 Checks before starting the instrument

During operation, always check for any abnormal sound, water leakages or other abnormal
condition. If a trouble occurs, take suitable safety measures according to the condition and
contact your Roche service representative.

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Starting the analyzer

a To switch on the analyzer

System time: approximately 6 minutes (unless a Power Up Pipe function has been
programmed)
Please note that there is a prescribed order for switching on and off. The following
order has to be observed:
1 Switch on the power switch located on the right of the analytical unit.
The analyzer starts the initialization routine.

A B

A Power switch of analytical unit B Power switch of control unit

Figure B-21 Power switches

2 Switch on the computer of the control unit, the monitor, and the printer.
After initialization, the Logon screen is displayed.
3 Enter your operator ID and password to log on.
4 Choose OK to gain access to the software and begin operation.
When initialization has been completed, the system goes into Standby.

Some maintenance items must be performed daily at start-up of the analyzer. We

recommend performing them automatically by a maintenance pipe function.

e For information about maintenance pipes and about daily maintenance, see:
Maintenance pipes on page C-10
Daily maintenance—at power on or start up on page C-31

Sleep mode
Instead of switching off power after the working day, the analyzer can also be put into
sleep mode. Sleep mode provides the possibility of an automatic start-up on the next day.
Note that when the analyzer wakes up from sleep mode, the control unit performs a
shutdown to reset the PC operation software (Windows XP).

e For information about sleep mode and shutting down the analyzer, see:
Analyzer shutdown and sleep mode on page B-71.

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Starting the analyzer

Instrument statuses

This section explains the most important operational statuses (modes). The status is
displayed in the upper left of the monitor.

Figure B-22 Instrument status, e.g. Standby mode

Check the upper left of the monitor before starting a new analysis or a maintenance
item:
o Stand By: If Stand By is displayed with a white background, the analyzer is ready
to start a new analysis or a system-controlled maintenance item. The top cover
must be closed.
o Maintenance mode: If the status line is displayed with a yellow background, the
analyzer is ready for maintenance actions that are performed with the top cover
open.
e For information about the required status for each maintenance item, see:
Overview of maintenance schedules on page C-28

Standby mode Standby is an operational status of the analyzer during which power is on but no
sample analysis or maintenance procedures are being performed automatically.

Maintenance mode By means of the maintenance switch you can turn off the low voltage power to the
pipetters and the reaction disk without having to go into complete shutdown. Use the
Maintenance mode (or shutdown) for all actions that are performed with the top
cover open.
e See: Maintenance mode on page B-33

Shutdown status Shutdown status is the condition where the analyzer and control unit are
disconnected and the operation power switch is switched off. However, power for
keeping the reagents cool is still supplied.

If power to the analyzer is switched off prior to the complete shutdown of the computer,
the instrument may not start up properly when power is supplied again.
o Make sure the monitor indication has changed from shutdown to a state where
nothing is displayed.
o Then, switch off the analyzer power switch.

e See: To shut down the analyzer on page B-72

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Starting the analyzer

Maintenance mode
In Maintenance mode, the motors driving the pipetter probes, the sample and
reaction disk are turned off, while the analyzer remains powered on.
Any actions which require the top cover to be open (such as replacing ISE reagents or
maintenance actions, or checks) may only be performed in Maintenance mode (or
shutdown).

A Maintenance switch

Figure B-23 Maintenance switch

a To put the analyzer in Maintenance mode (yellow bar in status line)

NOTICE Damage to the analyzer due to improper use

Always confirm that the analyzer is in Standby status before you activate the maintenance
switch. If you use the maintenance switch to change to Maintenance mode while the
analyzer is in Operation status or Sampling Stop status, the analyzer stops operation and
may be damaged.
o Make sure that the analyzer is in Standby before you put it into Maintenance mode.

1 Turn the maintenance switch (located on the right side of the analytical unit) to
Maintenance Mode.
The status line turns bright yellow. The yellow color indicates that the analyzer is
in Maintenance mode, even if Stand By is still displayed.

Figure B-24 Maintenance mode indicated by the yellow status line

2 Unlock and open the top cover of the analyzer.

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Starting the analyzer

a To terminate Maintenance mode

1 Close and lock the top cover of the analyzer.
2 Turn the maintenance switch to Operation mode.
The status line turns back to white. Stand By is displayed.
3 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.

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Starting the analyzer

Check system alarms

If an alarm was issued, the Alarm global button flashes. The color of this button
stands for the alarm level. Yellow indicates the caution level and red the stop level.
When the global button Alarm flashes, it is necessary to open the Alarm screen to
view the alarm. The Alarm screen identifies all system alarm conditions.

Figure B-25 Alarm screen

a To review the Alarm screen

1 Choose Alarm (global button) to display the Alarm screen.
2 Select an alarm to view the description and remedies (displayed in the lower half
of the screen).
3 Correct any alarm conditions by following the remedies.
e If any problems arise, refer to the specific troubleshooting chapter Data alarms on
page D-3.

4 After you have carried out remedial actions, choose Delete.

The relevant alarm indication will disappear and the color of the Alarm will
return to its original state (blue).
5 Choose Close to close the Alarm screen.

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Starting the analyzer

System Overview screen

The System Overview screen plays a central role within the cobas c 311 analyzer
software. This screen provides the operator with an overview of the whole system at
any given time and the analyzer can be prepared for daily routine operation (via the
Work Flow Guide).

Figure B-26 System Overview screen

It is possible to call up the System Overview screen from any point of the software—
Workplace, Reagent, Calibration, QC, or Utility— by choosing this icon in the top left
corner of the screen or by pressing F12.
e For a list of all shortcut keys, see:
Shortcut keys on page B-24.

The Work Flow Guide area at the top of the System Overview screen guides you
through the preroutine operation.
The Overview area provides a view of the current status of the analyzer and
components of the cobas c 311 analyzer.
The lower section of the Overview area displays information relevant to the
component currently selected such as incubator temperature (INC.).

Before performing any measurements, check that the temperature of the incubator
is within 37°C ± 0.1°C.
o A wrong temperature may result in incorrect measurement results and lead to
incorrect results for the photometer check (maintenance item (2) Photometer Check).
o An alarm will be issued when the temperature reaches 37°C ± 0.5°C.
o Depending on the ambient temperature, it can take up to 30 minutes to reach the
correct temperature after switching on the analyzer or after exchange of incubation
water (maintenance item (4) Incubation Water Exchange).

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Alarm This button displays the color corresponding to the highest priority alarm of the
currently selected component. Choose this button to display the global Alarm screen.
The alarm(s) corresponds to the component currently selected.
e See Check system alarms on page B-35.
e For a detailed description of the Alarm screen, refer to the Online Help.

Reagent Overview Choose this button to display an overview of the reagents currently loaded. This
button is only visible if you have selected AU (analyzer unit).
e See Reagent Overview button on page B-111.

Color scheme of the System Overview screen

The System Overview screen uses colors to display the status of the system. The color
scheme is different when preventive action is activated by selecting the Preventive
Action check box. The following table describes the meaning of the color scheme for
each button on the System Overview screen.

Colors in the Work Flow Guide

Figure B-27 Work Flow Guide area of the System Overview screen

Buttons in Work Flow Guide area Color Meaning

Daily Red A maintenance item has expired.

Maintenance Yellow A maintenance item is about to expire.

Sample Data Red The database is full (10 000 records). No additional samples can
Clear be processed until the hard disk is cleared.
Yellow The database is nearly full (more than 9400 records).
Reagent Red Reagent for at least one test or detergent required for the test is
Preparing not on board (mandatory) or is empty.
Yellow The number of tests remaining for a reagent, diluent, or wash
solution is below the yellow alarm threshold.
Purple The number of tests remaining for a diluent, test reagent or
detergent volume is less than the daily requirement - only
applicable if the Preventive Action check box has been selected.
Calibration and Yellow The system has recommended a calibration or quality control.
QC Select

Parameter Red A reagent, calibrator, or QC was loaded onto the analyzer, which
Download has not been installed before. New information for applications,
controls, and calibrators must be downloaded from cobas link.
Sample Blue This button is used to track samples, it does not change color.
Tracking

Table B-5 Color scheme Work Flow Guide area

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Colors in the Overview area

Figure B-28 Overview area of the System Overview screen

Buttons in the Overview area Color Meaning

Host, Core, and Control Unit Red An instrument alarm at the Stop, S.Stop or E.Stop level.
Yellow An instrument alarm at a caution level.
Light blue Indicates a status other than Standby (e.g., Operation or
Maintenance).
Light green Indicates Standby mode.
Analyzer (AU and ISE) Red Indicates an instrument alarm at the Stop, S.Stop or E.Stop level
or that a reagent is empty and there is no second cobas c pack
placed on this analyzer.
Yellow Indicates an instrument alarm at a caution level or that the
number of remaining tests is below the yellow alarm level
threshold.(a)
Purple Indicates that the number of tests remaining for a diluent, test
reagent or detergent volume is less than the daily requirement(a) -
only applicable if the Preventive Action check box has been
selected.
Light blue Indicates a status other than Standby (e.g., Operation or
Maintenance).
Light green Indicates Standby mode.
Red A reagent is empty and there is no second cobas c pack placed on
Reagent Overview
the analyzer.

Yellow The number of tests remaining for a reagent is below the yellow
alarm level threshold.(a)
Red Indicates an instrument alarm at the Stop, S.Stop or E.Stop level
Alarm

Yellow Indicates an instrument alarm at a caution level

Table B-6 Color scheme of the Overview area
(a) Specified on the Utility > System (Page 2/5) > Reagent Level Check window.

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Work Flow Guide

The Work Flow Guide area at the top of the System Overview screen guides you
through the preroutine operation.

Figure B-29 Work Flow Guide

The Work Flow Guide area consists of 6 buttons: Daily Maintenance, Sample Data
Clear, Reagent Preparing, Calibration and QC Select, Parameter Download, and
Sample Tracking. The first five buttons are placed in the suggested sequence of
preventive action. If a button is not highlighted, that action is not necessary.
The Sample Tracking button is used to search for samples on the analyzer. This is
possible at any time during operation as long as no samples have been removed from
the sample disk and no new run has been started.
e For more information about the meaning of the colors, see:
Color scheme Work Flow Guide area, Table B-5 on page B-37.

Preventive action
Preventive action is a look ahead at what might be required during daily routine
operation. When activated, preventive action triggers the following items:
o Reagent purple alarm
o Calibrate Now
On logon, the Preventive Action check box on the System Overview screen is selected
and therefore active.
For routine operation we recommend deselecting the Preventive Action check box
because it is not necessary to be informed about the triggered alarms.

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Preroutine operation

Before you can start routine operation you must first prepare the system for
operation. Preroutine operation involves the following tasks:
o Performing maintenance actions
o Clearing and backing up data, if necessary
o Preparation of reagents, detergents and diluents
o Calibration
o Measurement of quality controls
o Download of parameters, if necessary
The Work Flow Guide area at the top of the System Overview screen guides you
through the preroutine operation.

Daily Maintenance button

Requirements: Define The Daily Maintenance button indicates when maintenance intervals are about to
maintenance types expire. However this function is available only if maintenance intervals for
maintenance items are defined.
e For more information, see
Color scheme Work Flow Guide area, Table B-5 on page B-37.
Maintenance types—scheduling and tracking maintenance items on page C-8.

Choosing Daily Maintenance on the Work Flow Guide area displays the Maintenance
screen. Use the Maintenance screen to execute maintenance actions or maintenance
pipe functions.
e See Performing maintenance items on page C-9.

Define a Power Up Pipe For a proper use of the analyzer Roche recommends performing some maintenance
items regularly. We recommend making these maintenance items automatic by means
of maintenance pipes.
e See Recommended maintenance pipes on page C-15.

o Daily maintenance items may be programmed as a Power Up Pipe and will then be
performed automatically when powering on the system.
o To keep your analyzer up-to-date and to receive important information from cobas link
we recommend including the maintenance item cobas link Essential Information Upload
into the Power Up Pipe.
o The date of execution is updated each time a maintenance item is executed. It will be
updated even if operation is interrupted due to an alarm, etc. In this case, execute the
relevant maintenance item again and terminate it normally.

e For more information, see:

Maintenance pipes on page C-10
Power Up Pipe function on page C-13
Start Up Pipe function on page C-14

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a To perform daily maintenance items and checks

1 After power-on, make sure that the daily maintenance items are executed by the
Power Up Pipe function, or perform them manually.
e See: Daily maintenance—at power on or start up on page C-31.

2 While the analyzer executes the Power Up Pipe, perform the visual checks as
described (with top cover closed).
3 When the Power Up Pipe is finished, perform the visual checks as described.
4 Choose the System Overview screen.
o Choose the Daily Maintenance button if it is yellow or red. Perform the
indicated maintenance items.
o Before starting analysis, check that the temperature of the incubator bath is
within 37°C ± 0.1°C.
5 Continue with the following preroutine steps.

Sample Data Clear button

Use the Sample Data Clear button to delete all measurement results of routine and
Stat samples. Less sample data on the hard disk allows faster access to the data.
Backing up on a periodic basis is recommended.

NOTICE Deleting patient results

Clearing the sample database deletes all patient results currently stored on the hard disk.
Any control results are moved to the QC view of data review.
o If your analyzer is connected to a Host, make sure that all data have been uploaded
before clearing the sample database.
o Back up all results when clearing the sample database.

Figure B-30 Sample Data Clear window

e See Archiving patient data on page B-89.

o Once the hard disk is full, no more sample data can be saved. In the System Overview
screen the Sample Data Clear button turns to red. To save further data, the hard disk
must be cleared.
o It is strongly recommended that a sample clear is performed daily to minimize the risk
of data loss.

e For more information, see Color scheme Work Flow Guide

Table B-5 on page B-37

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If a sample is measured with the same sample ID or same number as an already measured
sample, the results will be displayed with the original sample number or ID.

Reagent Preparing button

Requirements: Define reagent The Reagent Preparing button indicates that insufficient amounts of reagent remain.
warning levels and mandatory However, this function is available only if the test counts (or volumes) for the reagent
tests level check and the mandatory tests were defined.

Define reagent warning levels The Reagent Preparing button changes its color to yellow or purple if the
corresponding alarm has been selected for one or more tests. Define reagent warning
levels for the yellow and purple alarm under Utility > System (2/5) > Reagent Level
Check for each reagent and detergent.
For the purple alarm, we recommend setting the volume of reagents to be used in one
day.
The purple alarm however, will only appear if the Preventive Action check box in the
System Overview Screen has been selected.

Define mandatory tests The Reagent Preparing button changes its color to red if a reagent or detergent is
empty or if a reagent has been defined as mandatory and is not on board. Mandatory
tests are defined under Utility > Module Set > Test Assignment. Detergents and
diluents can not be defined as mandatory.
e For more information, see Color scheme Work Flow Guide:
Color scheme Work Flow Guide area on page B-37
Define reagent warning levels on page B-42.

Print Reagent Load/Unload List The Reagent Load/Unload List displays the cobas c packs and auxiliary reagents that
need to be replenished on the system.

a To print a Reagent Load/Unload List

1 Choose Reagent Preparing on the System Overview screen.
2 Choose Reagent Load/Unload List on the Reagent Preparing window.
A confirmation window appears.
3 Choose Yes to print the Reagent Load/Unload List.
Now, replace any required reagent, diluent, detergent, or wash solution according to
the Reagent Load/Unload List. Ensure that reagents have not exceeded their
expiration dates.

ISE reagents
The ISE auxiliary reagents (ISE IS, ISE Dil., and ISE Ref.) are stored in reagent bottles
in corresponding ISE reagent compartments.
Replace all required reagents as indicated on the Reagent Load List. Make sure to
place them according to their correct positions.
The analyzer must be in Maintenance mode (bright yellow status line) or shutdown
during replacement.

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After replacement, the following steps must be performed:

1. Reagent level reset:
The volume must be reset under Reagent > Setting > Reagent Level Reset. For
ISE IS and ISE Dil., the remaining volume is then reset after the first reagent level
detection. This is automatically performed by the reagent probe before starting a
measurement.
2. Reagent prime:
After the replacement of ISE IS or ISE Ref., a Reagent Prime is required to fill the
flow path with the new liquid.
3. ISE calibration:
A changeover calibration will be requested in the Calibration Status Screen.

ISE IS ISE Dil. ISE Ref.

Reagent level reset x x x
Reagent prime x - x
ISE calibration x x x
Table B-7 Required steps after replacement of ISE reagent bottles

e For more information about ISE reagents, see:

Reagents for ISE applications on page B-97
ISE reagent registration on page B-103
Notes on replacement of ISE reagents on page B-103.

Before performing the following actions, observe the following safety precautions:
o Skin inflammation or injury caused by reagents and other working solutions on page A-9
o Infection and injury due to contact with instrument mechanism on page B-3
o Incorrect results due to incorrect reagent volume on page A-10
o Incorrect results due to expired reagents or mixing reagents on page B-4

a To replace ISE IS or ISE Dil.

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.
3 Place a new bottle into the reagent position. Make sure to place it according to the
correct position.
4 Close the top cover of the analyzer and lock it.
5 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status).
6 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
7 Select the Reagent > Setting screen and select the reagent bottle that has been
replaced.
8 Choose Reagent > Setting > Reagent Level Reset and choose Yes.
A blank space is provided in the column Available Tests. The remaining volume
will be displayed after the first reagent level detection.

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9 After replacing the ISE IS bottle, perform a Reagent Prime and an ISE calibration.
After replacing the ISE Dil. bottle, perform an ISE calibration.
e See To perform a Reagent Prime on page B-44.

a To replace ISE reference solution (ISE Ref.)

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.
3 Remove the tubing from the ISE Ref. bottle and clean the ISE Ref. aspiration filter.
e See M10: Cleaning the ISE Ref. aspiration filter on page C-66.

4 Replace the ISE Ref. bottle, and place the tubing into the new bottle. Make sure
that the end of the tube touches the bottom of the bottle. Otherwise, reagent may
not be pipetted properly.

Incorrect results due to incorrect insertion of the ISE Ref. aspiration tube
If the aspiration tube is not inserted correctly, the reagent may not be dispensed properly.
CAUTION This may lead to incorrect results.
o Insert the aspiration tube so that the end of the tube touches the bottom of the bottle.
o Do not bend the aspiration tube.

5 Close the top cover of the analyzer and lock it.

6 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status).
7 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
8 Select the Reagent > Setting screen and select the reagent bottle that has been
replaced.
9 Choose Reagent > Setting > Reagent Level Reset and choose Yes.
After reset, an initial value of 279 ml is displayed in the column Available Tests.
10 After replacing the ISE Ref. bottle, perform a Reagent Prime and an ISE
calibration.

a To perform a Reagent Prime

1 From the System Overview screen, choose Reagent Preparing.
2 Choose Reagent Prime on the Reagent Preparing window.
3 Choose Parameter on the Reagent Prime window.
4 Select the type of reagent to be primed (ISE Ref. and ISE IS) and choose OK.
5 Back in the Reagent Prime window, choose Execute.
The prime is complete when the system returns to Standby.

If you have replaced a reagent bottle, calibrate the ISE unit before you resume routine
operation.

e For details on how to calibrate the ISE unit, see:

Calibration And QC Select button on page B-48
ISE calibration on page B-136.

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Loading cobas c packs

Replace all required photometric reagents and auxiliary reagents as indicated by the
Reagent Load List. Ensure that reagents have not exceeded their expiration date.

Incorrect results due to insufficient reagent volume

When using cobas c pack MULTI, it must be filled with the exact filling volume specified in
CAUTION the package insert. If this is not the case, measurement accuracy may deteriorate.
Additionally, an alarm (reagent short) may occur if the analyzer detects that the reagent
volume is low.
o Ensure that the cobas c pack MULTI contains the correct filling volume. Refer to the
package insert.

Loading cobas c packs It is only possible to load a cobas c pack when the analyzer is in Standby mode and the
applications have been downloaded from cobas link. Reagent registration takes a few
minutes as it includes piercing the cap and checking reagent volume.
The cobas c packs containing diluent for pre-dilution of samples, Hitergent for the
incubator water bath, and detergents for the reagent probe (NaOH-D and SMS) are
registered in the same way as other cobas c packs. For these solutions all relevant data
must be downloaded first from cobas link via Utility > Application > Download.

a To load a cobas c pack

1 Make sure that the analyzer is in Standby.
2 Choose Loading on the Reagent > Setting screen. The Cassette Loading window
opens.
3 Choose Execute. The analyzer turns the reagent disk to a free position and unlocks
the gate to the reagent loading station.

A Gate to the reagent loading station B Barcode reader

C Barcode label

Figure B-31 Scanning the barcode label on a cobas c pack

4 Open the gate to the reagent loading station.

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5 Slide a cobas c pack with the barcode label facing to the right side past the barcode
reader.
6 If reading is successful, you will be asked to confirm the cassette information. If
reading is not successful, an alarm occurs.

Incorrect results due to incorrect placement of reagent

If a cobas c pack (or COBAS INTEGRA cassette) is inserted the wrong way around,
CAUTION reagents will be pipetted in the wrong order, leading to incorrect results. The instrument
may also be damaged.
When inserting the cobas c pack, make sure the barcode is facing the barcode reader.

Problems occurring during scanning of barcode label

o If the barcode of a cobas c pack is facing the wrong way or the barcode is partly
covered by your fingers, the barcode information cannot be read and the
cobas c pack is not registered. Scan again.
o If the barcode label is unreadable an alarm occurs and the cobas c pack is not
accepted. In this case do not use this cobas c pack and close the gate.

7 Place the cobas c pack in the empty position on the reagent disk.
8 Close the gate covering the reagent loading station.

If the reagent disk cover is left open for more than ten minutes, an alarm will occur.

e For details of downloading parameters, see

Parameter Download button on page B-54.

9 The contents of Cassette Information is now displayed in the window.

10 If there are multiple cobas c packs, steps 4 to 9 above must be repeated as required.
11 After all cobas c packs are registered, click End.
Reagent registration is performed automatically when a new cobas c pack is
loaded. A manual reagent registration is not available. The analyzer automatically
registers all new cobas c packs and uses the reagent probe to physically check the
reagent level in each reagent bottle. Then, this initial reagent volume is counted
down with each pipetting.
e For more information, see:
Reagent registration on page B-104

Replacing auxiliary reagents e For instructions on how to replace auxiliary reagents, see:
To replace a cell detergent bottle on page B-109
To replace a sample probe detergent bottle on page B-109

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Unloading cobas c packs

If you need space on the reagent disk for other reagents, cobas c packs can be
unloaded. Use the same procedure to unload empty reagents.

a To unload a cobas c pack

1 Make sure that the analyzer is in Standby.
2 In the Reagent > Setting screen, select the cobas c pack that is to be unloaded (you
can also select multiple cassettes).
3 Choose Unloading to open the Cassette Unloading window.
4 Choose Execute.
The reagent disk turns to the slot position of the reagent in the lowest numbered
position. The gate to the reagent loading station will be unlocked.
5 Open the gate and take out the cobas c pack.
6 Close the gate.
In case multiple cassettes have been selected, repeat steps 5 and 6.
7 After unloading all of the cobas c packs, choose End.

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Calibration And QC Select button

It is necessary to calibrate all applications and measure quality control (QC) samples
regularly to verify the stability of reagents and the entire system. Make sure that
calibration has been completed successfully and that all QC results are OK before you
start routine operation.
Calibration and QC intervals vary from application to application and therefore each
application has its own configuration. In line with this configuration, the system
automatically recommends calibrations and QC measurements for all registered
applications.
Every time the system recommends a calibration this is indicated by the Calibration
And QC Select button turning yellow.
The following sections describe how to carry out a recommended calibration. The
instructions are based on the assumption that all calibration and QC configurations
have already been set.
e For general information on calibration, see:
Calibration concept on page B-117
Triggers for automatic calibration requests on page B-118
e For information on calibration settings, see:
Description of application parameters - Calib. tab on page B-182
To select tests for start-up group calibration on page B-124
e For information on QC settings, see:
To perform controls for active reagents on page B-148
To perform controls for standby cobas c packs on page B-148
To perform QC after calibration on page B-149.

The entire calibration and QC process comprises the following parts:

1. Requesting calibration and QC and printing load lists.
2. Measuring calibrators and controls.
3. Validating calibration and QC results.
In the following each of these parts is described. However, some details may vary
depending on your laboratory’s choice of a specific calibration workflow (e.g., time-
triggered calibration or QC-triggered calibration).

Requesting calibration and QC and printing load lists

Use the Calibration And QC Select button to select the calibrations and QC to be
performed. Choose this button to display the Calibration And QC Select window,
from which calibration and quality controls are selected and calibrator and QC load
lists can be printed.
Use the following procedure to request the recommended calibrations and controls. If
you need to select additional calibrations manually, select these from the
Calibration > Status screen.
e See Requesting and cancelling calibrations manually on page B-123.

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a To request calibration and QC

1 Choose Calibration And QC Select in the Work Flow Guide area.

Figure B-32 Calibration And QC Select window

2 Choose the buttons that are yellow in both the Calibration area and the QC area to
select the recommended calibrations and controls for measurement.

In case there are reagents on board with less than ten tests remaining, a confirmation
window opens and it is possible to cancel the calibration/QC request for these reagents.

3 Select the list you want to print from the Load List area:
o Calibration Only comprises all requested calibrations.
o QC Only comprises all requested QCs including QC after calibration.
4 Choose Print to print the selected Load Lists. The Calibrator and QC Load Lists
display all calibrators and controls that are necessary for performing the requested
measurements.

If you need to run QC for standby cassettes, do one of the following:

o Choose Stand By Bottle QC to request a QC for all standby bottles.
o Choose QC > Status > Stand By Bottle QC, select individual tests from the list, and
choose OK.

5 Load the calibrators and controls onto the analyzer as directed by the Calibration
load list and the QC Load List, see: To load required calibrators and controls on
page B-51.

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QC Load List 07/07/31 11:12

-----------------------------------------System Specific Position--------------------------------

NAME LOT POS.NO.

HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
biorad 90909 C088
HBCP 67983300 C084

-----------------------------------------QC after Calib.-----------------------------------------

NAME LOT POS.NO.
HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
HBCP 67983300 C084

Table B-8 QC Load List report

Calibration Load List 07/07/09 10:39

NAME LOT Pos.NO.

CFA1C 17514200 S073
CFAS 17272700 S080
H2O 99999900 S079
C-PUC 17600900 S075
ISELOW 67873301 S068
ISEHIGH 67872901 S069
ISECOMP 17682800 S070

Figure B-33 Calibration Load List report

e For more information about the different information on printouts, refer to the Online
Help of the particular report.

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a To load required calibrators and controls

1 Using the load list as a guide, prepare all required calibrator and control materials
according to the manufacturer's instructions.

o Note that Hitachi micro cups are not applicable to calibrators and QCs.
o Before placing calibrators and controls in the sample disk, check that no bubbles or
foam are visible on the surface of the liquid.
o If you perform QC after calibration, QC samples do not have to follow directly after
calibrator samples. Other samples can be placed in between them.

2 Load calibrators and controls onto the sample disk.

Calibration or QC failure
If you have to manually assign a calibrator or QC container or other sample container—for
CAUTION example, due to an unreadable barcode—do not place any containers with barcodes in
manually assigned positions.
It is possible to do a calibration with a mixture of barcoded and non-barcoded calibrators.
However, you must assign the position of the non-barcoded calibrator and no position
should be assigned for the barcoded calibrator. If you put a barcoded container on a
position that was assigned manually, the calibration is not measured.

Incorrect results due to expired calibrators or controls

Data obtained using expired calibrators or controls are not reliable.
CAUTION Do not use calibrators or controls that have exceeded their expiration dates.

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Measuring calibrators and controls

Once calibrations and QCs are requested and the calibrators and controls are placed
in the sample disk, the measurements can be started.
Calibration and QC is usually performed at the beginning of routine operation before
sample processing begins. However, it can be carried out anytime during routine
operation.

a To measure calibrators and controls

1 Make sure that the calibrator and control samples are loaded according to the load
list.
2 Choose Start (global button).

Figure B-34 Start Conditions screen (barcode mode)

3 Verify the settings on the Start Conditions screen.

Only when operating in non-barcode mode and if patient samples are already
onboard, enter the sequence number of the first patient sample to be analyzed
into the Start Sample No. text box. This number refers to the Sequence No. in the
Test Selection screen.
4 Choose Start on the Start Conditions screen. The Start screen closes and the
calibration and control run begins.
The sample disk rotates and checks to see if a position on the sample disk is
occupied. In barcode mode, each sample ID will be read.

If an unregistered barcode is read for a calibrator or control sample, a barcode reading

error alarm is issued. In this case, the Parameter Download button on the System Overview
screen turns red. Choose Parameter Download and download the necessary parameters.

If automatic printout of calibration and QC is selected on Utility > System (Page 4/5) >
Automatic Printout, the Calibration Monitor and Control Result Monitor reports are
automatically printed when the measurements are completed.

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Validating calibration and QC results

It is important to verify that calibrations and QC results are valid before measuring
routine samples. Validation can be performed either through the Host or on the
system. For routine operation it is sufficient to validate calibrations and QC by means
of the System Overview screen:
o A failed or newly recommended calibration is indicated on the System Overview
screen by the Calibration and QC Select button turning yellow.
e Detailed information on calibration results can be viewed on the Calibration > Status
screen, see:
Calibration Status screen on page B-122
Reviewing calibration data on page B-125.
e Detailed information on quality control results can be viewed on the QC > Individual
screen, see:
QC Individual screen on page B-152.

If the automatic printout of calibration or QC results is configured (under Utility >

System (Page 4/5) > Automatic Printout), it is possible to use these printouts for
validation, too.

If calibration or QC failed… In case a calibration fails or a QC result falls outside the expected range, check for QC
data alarms on the Workplace > Data Review screen and calibration alarms on the
printouts.
Data alarms are issued when measurement values or results are in any way unusual or
unexpected. Data alarms appear on screen and on reports as short strings (up to six
characters) also referred to as data flags. Look up the meaning of each data flag and
possible remedies in the troubleshooting part of this manual.
e See Chapter 15 Data alarms.

After taking the necessary measures, repeat the calibration or QC before you begin
routine analysis.

If a realtime QC rule is violated, the system issues a realtime QC alarm. Make sure that you
check the results of the QC to see if the values are within the range.

Quality control results The results of QC measurements are saved in the database and displayed on the Data
Review screen as well as on the QC > Individual screen. QC can also be checked in the
Run Status screen instead of in the Individual QC screen.
It is important to regularly consolidate these results (by pressing the Accumulate
button) in order to generate long term quality control data (QC > Cumulative).
e For information on accumulation of control data, see:
Accumulation of QC measurement data on page B-145.

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Preroutine operation

Parameter Download button

When the Parameter Download button is red, new parameters for applications,
calibrators, and controls must be downloaded from cobas link. Choose Parameter
Download in the System Overview screen to open the To Do List window.
e For an overview of downloading parameters from cobas link, see:
Loading or updating applications on page B-174.

a To download new information

1 Choose the Parameter Download button in the System Overview screen.

Figure B-35 To Do List window

2 Choose the tab corresponding to the item you want to download.

3 Select an item from the list and choose Download.
The corresponding screen will be opened, e.g. the Utility > Application > Calib.
screen for application parameters.
4 Choose the Download button to open the Download window.
e The following steps are described in the corresponding chapters:
Loading application parameters on page B-174
Loading calibrator data on page B-131
Loading control data on page B-165

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Sample Tracking button

The Sample Tracking window provides an overview of the samples in the sample disk
and allows the operator to search for samples which have already been registered by
the system.

Figure B-36 Sample Tracking window

Empty The sample position is empty.

Cup Present A cup is present but no request has been made.

Processing The sample is being processed.

Completed Sample is complete with no flags.

Wrong A sample whose ID is duplicated in the Sample ID mode or

barcode on manually assigned position.
Failed The result is outside the measurement range, the measurement
result contains one or more data alarms, if a test is masked.
Sample Error Sampling could not be performed for this sample due to one of
the following reasons:
o Sample volume is too low
o Sample clot
o Air bubbles
If the alarm sample short, sample clot, or sample air bubble occurs,
all subsequently ordered test for this particular sample and run
are canceled. A manual rerun is required.
Barcode Error The barcode is unreadable (displayed in barcode mode only).

e For more information, see:

Sample tracking on page B-66
Tracking samples on the analyzer on page B-93
Refer to the Online Help of the particular window.

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Routine Operation

Routine Operation

After completing preroutine operation, you are ready to start routine operation.

Before continuing with routine operation, deselect the Preventive Action check box on the
System Overview screen. Otherwise, the system will issue purple and other irrelevant
alarms in the course of routine operation.

Routine operation involves the following items:

1 Processing routine samples
2 Processing STAT samples
3 Processing reruns
4 Checking results and handling of data
5 Sampling Stop
The way in which routine operation works will vary depending on the following
system settings and sample properties:
o Whether routine or STAT samples are being analyzed
o Whether the analyzer is operating in barcode mode or not (set in the Barcode
Setting area under Utility > System)
o Whether the analyzer is operating in connection with a Host computer

Before performing the following actions, observe the following safety precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page B-3
o Incorrect results due to incorrect reagent volume on page A-10
o Incorrect results and interruption of analysis due to contaminated samples on page A-10
o Incorrect results due to evaporation of samples or reagents on page A-11
o Incorrect results due to carryover on page A-11
o Incorrect results due to position mismatch on page B-4
o Incorrect results due to missing covers of the ISE unit on page B-4
o Incorrect results due to aspiration of air on page B-4

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Processing routine samples

In this section, we describe the workflow for an analyzer that operates in connection
with a Host and is set to process routine samples in barcode mode. Processing
samples always includes the following three steps:
1. Test selection
2. Loading samples
3. Starting the measurement

Test selection
Test selections for routine samples are usually downloaded from the Host. However,
these test selections may be changed manually—regardless of the mode (Standby,
Stop, Operation, or Sample Stop) the analyzer is in. When working without a Host,
the test selection must be entered manually.
e For information on manual test selections, see Requesting a test manually on page B-81.

Loading routine samples

Once test selections have been made on your Host system or on the analyzer, put the
samples into the sample disk observing the notes below. If needed, print a requisition
list from Print (global button) > Workplace > Requisition List.
e For more details on printing the Requisition List, refer to the Online Help.

a To load patient samples

1 Prepare patient samples.

Personal injury due to touching moving parts

The green Access Sample Disk lamp next to the sample disk indicates that the sample disk
CAUTION will not rotate until renewed operation is actively initiated by the operator.
Only load samples when the green Access Sample Disk lamp is on.

Incorrect results due to sample mismatch

When operating in non-barcode mode, make sure to load the samples to their registered
CAUTION positions. The registered tests and sample positions can be checked by printing a
Requisition list (Print (global button) > Workplace > Requisition List).

2 Load the patient samples onto the sample disk.

Make sure that you place samples on a permitted position.

Do not place barcoded samples on a manually assigned position.

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max. 88 mm
C

A Sample tube (100 mm) C Barcode scan range

B Notch between sample cup positions

Figure B-37 Sample tubes on the outer ring with their barcode facing outwards

3 Ensure that the sample barcodes are facing the right way so the two barcode
readers can scan them. Samples placed in the inner ring must have their barcodes
facing inwards, samples placed in the outer ring must have their barcodes facing
outwards (see Figure B-37 on page B-58).
e For specifications of the correct position of the barcode label, see:
Scan range for sample barcodes on page A-77

Starting the measurement

Before starting a run, ensure that all test selections have been made and all necessary
samples (calibrators and controls if requested) have been loaded.

a To start processing
1 Choose Start (global button).

Figure B-38 Start Conditions screen (barcode mode)

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Figure B-39 Start Conditions screen (non-barcode mode)

2 Verify the settings on the Start Conditions screen.

When operating in non-barcode mode, enter the sequence number of the first
patient sample to be analyzed into the Start Sample No. text box. This number
refers to the Sequence No. in the Test Selection screen.
e For more information on setting the start conditions, see:
Start Up Pipe function on page C-14
To activate the automatic rerun function (system-wide) on page B-62.

3 Choose Start (on the Start Conditions screen).

The system performs a short preparation routine (approx. 5 minutes) and then
begins to process the samples. The sample disk rotates and checks to see which
positions on the sample disk are occupied. In barcode mode, each sample ID will
be read.
e For information on checking the results, see:
Checking results and handling of data on page B-65.

Processing additional samples

There are two priority levels: STAT (emergency) and routine, where the first takes
priority over the second. In either case, test selections for additional samples are
downloaded from the Host in realtime. STAT samples can be measured through
interruption of the routine samples under sampling.
e For information on manual test selections, see Requesting a test manually on page B-81.

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a To process additional samples during operation

1 Choose Pause/Scan (global button).
2 Choose Pause on the Sample Pause/Scan window.
In non-barcode mode, a window appears warning you not to exchange any
samples.
o If you choose Pause/S.Stop, you can add additional samples once pipetting
stops and the green Sample Disk Access Lamp comes on. The status line shows
Sampling Pause.
o If you do not want to add any samples, choose Continue and then Close.

Incorrect results due to sample mismatch

o When operating in non-barcode mode, make sure to load the samples to their
CAUTION registered positions.
o Do not move or exchange any samples that are already on the disk.

3 Wait until the Access Sample Disk lamp comes on.

o If a routine sample is currently being pipetted, it takes about 3-4 pipetting cycles
before the instrument enters Sampling Pause status.
o If a STAT sample is currently being pipetted, pipetting of all tests of the STAT sample
will be completed before entering Sampling Pause status.
o Pipetting of calibrator or QC samples can not be paused. Press the Pause button again
when pipetting of all requested calibrators and QCs is completed.

4 Load the additional samples onto the disk.

5 Choose Start (global button) to open the Start Conditions screen.
6 Choose Start on the Start Conditions screen to initiate the run.
In non-barcode mode, a window opens asking you to confirm that no samples
have been exchanged. If you choose Not Exchanged, the instrument goes back to
Operation.
The sample disk rotates and checks to see which positions on the sample disk are
occupied. In barcode mode, each sample ID will be read.

If non-barcoded samples have been exchanged, all test requests must be deleted. Choose
Exchanged and the Start Conditions screen appears again. Now, choose S.Stop (global
button) to put the analyzer into Standby and delete the test requests. After deletion, all test
selections must be re-entered or re-downloaded from the host.

Interruption of measurements
If you press the Stop button or a serious red alarm stops the analyzer, then no results
will be calculated for already pipetted samples. Sample status will change to Masked
or Ordered. Eliminate the cause and restart the measurement.

Incorrect results due to exchange of sample positions during interruption

o When operating in barcode mode, do not exchange any samples highlighted in green
CAUTION on the Sample Tracking screen.
o When operating in non-barcode mode, do not move or exchange any samples that are
already on the disk.

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Processing STAT samples

In this section, we describe the workflow for an analyzer that operates in connection
with a Host and is set to process STAT samples in barcode mode.

Reserve sample disk positions for STAT samples

o To ensure that a STAT sample can be processed immediately, reserve a certain number
of positions on the sample disk for STAT samples in the Sample Disk Setting window
(Utility > System (3/4) > Sample Disk Setting).
o If Patient ID is selected for the barcode mode, assign each of the sample type positions
for routines and STATS. This is performed on the Utility > System screen by choosing
the Change button.

e For more information, see

Using patient IDs on page B-194
Sample Disk Setting button on page B-200

Test selection
Test selection for STAT samples is the same as for routine samples. That is, test
selections for samples are downloaded from the Host in realtime but may still be
changed from the analyzer’s control unit.
e For information on changing test selections, see Requesting a test manually on page B-81.

Loading STAT samples

Once test selections have been made on your Host system or on the analyzer, load the
STAT samples onto the analyzer observing the notes below.

a To load STAT samples

1 Prepare the STAT samples.
To verify the correct sample positions for each STAT sample type, refer to the
Position Assignment area on the Utility > System screen.

You can check the Sample Tracking screen for reserved STAT positions in both Patient ID
mode and Sample ID mode.

2 Continue as described in To process additional samples during operation on

page B-60.

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Processing reruns

Rerun samples can be processed in two ways: as automatic reruns or as manual

reruns.

Automatic reruns
If a test result is flagged with a data alarm (e.g., the result is outside the technical
limits, >Test alarm) and the automatic rerun function is activated, this test will be
measured again.
Automatic reruns can be performed for most of the data alarms, except for some
alarms according to the rerun list.
e For information on data alarms that can cause an automatic rerun, see:
Rerun list on page D-41.

Automatic reruns can be activated system-wide or application-specific:

o Automatic reruns can be activated for all tests (system-wide setting) in the Start
Conditions screen.
o By means of the application-specific setting you can include or exclude tests from the
automatic rerun (Utility > Application > Range).

The following table shows in which cases an automatic rerun will be performed for a
specific test if the result of this test is flagged with a data alarm:

Automatic rerun setting Rerun

System-wide Application-specific is requested is performed
YES YES l l
(a)
YES NO l –
(a)
NO YES l –
NO NO l(a) –
Table B-9 Correlation between the system-wide and the application-specific rerun setting
(a) The sample status changes back to Ordered (O). An automatic rerun can be performed by restarting the
measurement.

System-wide setting The system-wide setting is displayed in the Automatic Rerun area on the Start
Conditions window.

a To activate the automatic rerun function (system-wide)

1 Choose Start (global button).
2 Choose Change in the Automatic Rerun area to verify the system-wide rerun
setting.

Figure B-40 Automatic Rerun window

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3 Select the Routine check box or STAT check box (or both) to process reruns
without operator intervention. Routine and STAT reruns can be selected
separately.
4 Choose OK to save the rerun setting.
5 Choose Cancel to close the Start Conditions screen.

Application-specific setting Automatic reruns are performed depending on whether the Automatic Rerun check
box on Utility > Application > Range is selected or not for each test. If it is, the test is
automatically requested for rerun and remeasured whenever a result is flagged with a
specific data alarm. This applies to data alarms which indicate that a result is outside
the technical or repeat limit (>Test, <Test, >Rept, <Rept data alarms). Selection of the
Automatic Rerun check box is an application-specific setting; that is, it has to be set
for each individual application.
e For information on using the application-specific rerun setting, see:
Automatic Rerun on page B-187
Repeat limit on page B-188.

Manual reruns
If Automatic Rerun is set to NO in the Start Conditions window, all reruns are to be
processed manually (regardless of application-specific settings). This is an advantage
when you aim for an optimized throughput.
e For information about performing manual reruns, see:
Performing manual reruns on page B-84.

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Reruns with changed sample volumes

Tests that need to be rerun can be measured with normal, decreased, or increased
sample volumes or with diluted samples.

Photometric unit ISE unit

Decreased sample volume l l(a)
Increased sample volume l –
Diluted sample l –
Table B-10 Availability of dilutions for reruns
(a) only for urine samples, only manual rerun

These dilutions, performed by the system, can either be programmed to be performed

automatically or they can be requested manually by the operator or they can be
requested by the Host.
e Refer to the method sheet of the respective application for recommended dilutions.

Make sure that sufficient diluent is loaded for the system to dilute samples.

Automatic dilutions Individual tests can be configured with a dilution for the first run and/or rerun.
Dilutions defined in the system are automatically performed and calculated by the
system. Administrator access is required to define these dilution parameters (Utility >
Application > Analyze).
e For more information, see:
Sample Volume area on page B-181

Manually requested dilutions Dilutions can be requested by the operator. Choose the Sample Volume / Dilution box
on Workplace > Test Selection and select Decrease, Increase, or a dilution ratio (1:3 -
1:50).
e For more information, see Requesting a test manually on page B-81.

Request from Host Dilutions can also be requested by a Host computer. In this case, the samples are in
the sample disk and processed again.

Prediluted samples
Manually prediluted samples are samples which have been prediluted before they
were put on the analyzer. (These are not to be confused with manually requested
dilutions.)

Samples which have been manually prediluted can be measured, but the corresponding
dilution factors are NOT taken into consideration when the results are calculated by the
system. It is the operator's responsibility to calculate the final results.

In case you predilute a sample before you reload it onto the analyzer, make sure to
select the Pre-dilution check box on Workplace > Test Selection. The results will then
be flagged with a P (either on the printout or when sending the result to the host).
This indicates that the sample was prediluted and the customer must calculate the
final result.

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Checking results and handling of data

As results are generated on the instrument, they are saved in the database located on
the internal hard disk of the control unit. When all the test results requested for a
particular sample are available, the analyzer sends them to the Host where they can be
validated (automatic Host communication is activated by default).

Figure B-41 Data Review screen (barcode mode)

Checking results To view or edit results on the analyzer, use the Workplace > Data Review screen; all
test results in the database are displayed here.
The St. column on the left side displays the status of each sample:

O (Ordered) Sample registered by user or Host.

P (Processing) Sample is being processed.
I (Incomplete) Sample is measured, but a data flag is present.
No symbol (Complete) Sample successfully processed (no alarm present).
H (Sent to Host) Sample results have been sent to the Host.

e For a detailed description of the Data Review screen, refer to the Online Help.
e For more information, see:
Data Review screen on page B-88
Archiving patient data on page B-89
Editing or deleting sample data on page B-90
Tracking samples on the analyzer on page B-93

Sending data to the Host If results have been edited or if automatic Host communication is deactivated, always
make sure to choose the Send To Host button. You can select multiple test results and
transmit them collectively.
If an automatic rerun is performed, the results for the original test and the rerun are
reported separately to the Host.

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To check whether the automatic Host communication is activated or not, choose the Result
Upload Setting tab on the Utility > System (Page 1/5) > Host Communication Setting
window (available in administrator level only).

When checking results, it may become necessary to locate a certain sample for further
inspection. If a sample is still on the analyzer, use System Overview > Sample
Tracking to locate it.

Sample tracking

In the Sample Tracking window, the analytical status of each sample in the sample disk is
displayed.

Figure B-42 Sample Tracking window

The Sample Tracking window provides an overview of all samples in the sample disk.
The Track Sample area on the right side of the screen displays detailed information
about each sample in the sample disk.

Position status The following statuses are displayed in the Sample Tracking window:

Empty The sample position is empty.

Cup Present A cup is present but no request has been made.

Processing The sample is being processed.

Completed Sample is complete with no flags.

Wrong A sample whose ID is duplicated in the Sample ID mode or

barcode on manually assigned position.

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Failed The result is outside the measurement range, the measurement

result contains one or more data alarms, if a test is masked.
Sample Error Sampling could not be performed for this sample due to one of
the following reasons:
o Sample volume is too low
o Sample clot
o Air bubbles
If the alarm sample short, sample clot, or sample air bubble occurs,
all subsequently ordered test for this particular sample and run
are canceled. A manual rerun is required.
Barcode Error The barcode is unreadable (displayed in barcode mode only).

e For more information, see:

Tracking samples on the analyzer on page B-93
Refer to the Online Help of the particular window.

Description of the information in the inner circle:

Waiting Time required to obtain results for this sample.

Sample Type Serum/plasma, urine, CSF, supernatant, other

Status Status of the position as it is shown in the Track Sample area.

Currently Sampling The analyzer is currently sampling this sample.

S. ID Sample ID of the sample currently being analyzed.

Test Test currently being carried out.

When you select a disk position, the number of the disk position is automatically
displayed next to the selected disk position. The position number of the sample that is
currently sampled is also depicted. If you select a position on the sample disk on
screen, this sample is automatically highlighted in the Track Sample area and vice
versa.

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Archiving data and performing data backups

The analyzer software manages several types of data and provides the following
storage routines.

Data type Storage routine Target To be performed

Test results Sending/Archiving after a) to Host automatically (or manually via Workplace > Data Review >
(patient data) measurement Send To Host)
b) to a DVD via Workplace > Data Review > Backup Data, or
via System Overview > Sample Data Clear > Backup And Clear

Important data, Backup function to cobas link via cobas link Essential Information Upload
configurable(a) (daily) data station (performed automatically by a Maintenance Pipe)

System parameters Backup after to a floppy disk via Utility > Maintenance > Parameter Read/Write
(re)programming

Figure B-43 Overview of data types and possible storage routines

(a) The data types to be stored on cobas link data station are configured by Roche service personnel during installation (e.g., calibrator and control data).

NOTICE Data loss due to erroneous operation or instrument troubles

Back up your data (measurement results and system parameters) at regular intervals.

a To minimize the risk of data loss, perform the following routines:

1 Make sure that all test results are archived on the Host or make a backup copy on a
DVD.
e For more information about backups, see
Archiving patient data on page B-89

2 We recommend using the backup function in a daily maintenance pipe to store

relevant data on the hard disk of the cobas link data station.
e For more information, see:
Defining and editing maintenance pipes on page C-11
Recommended maintenance pipes on page C-15
cobas link Essential Information Upload on page C-23

3 Make a backup copy if you have changed any system parameters (e.g., application
parameters, see Table B-28 on page B-218).
e For more information, see:
Saving system parameters on page B-217

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Printing sample information

It is possible to print out sample information from the database if needed. The Data
Print report displays all test information about a particular sample ID (for example
tests performed and the results).

a To print a Data Print report

1 Choose Workplace > Data Review.
2 Select a single sample, a range of samples or nonconsecutive samples to be printed
from the sample list on the left side of the screen.
3 Choose Print (global button).

Figure B-44 Workplace Print screen

4 Choose Data Print in the report list.

5 Select the desired print format, Monitor or Report, from the Print Format area.
6 Select the appropriate run type, 1st, Rerun, Both or Chosen, from the Run Type
area.
7 Choose All in the Print Data area to print all results on the currently selected
sample(s) or choose Edited to select printing of only edited results of the currently
selected sample(s).
8 Choose Print to print the report.

For STAT samples, the results will be printed automatically if automatic printout of
Emergency Samples is selected on Utility > System (Page 4/5) > Automatic Printout.

e For more information about the different information on printouts, refer to the Online
Help of the particular report.

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Routine Operation

Sampling Stop

After all test requests are completed, sampling stops. After the last result is calculated,
the system remains in Sample Reception mode for a set period of time. This time
period is set in Utility > System > Sample Reception area. Thereafter, the entire
system goes into Standby.
The period of time that is to elapse before the analyzer switches from operation to
Standby mode is defined under Utility > System. A time must be entered in the
combo box to specify the interval between starting operation and Standby. If the
Sample Reception Mode is disabled in the Start Conditions screen, the system goes
into Standby immediately after the last result is calculated.

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Shutting down the analyzer

Shutting down the analyzer

This section discusses the tasks to be performed at the end of analysis. It gives a
detailed description of the shutdown including both complete shutdown and sleep
mode.

Maintenance before shutdown

At the end of routine operation, it is important that all required maintenance is

performed. In addition to routine daily maintenance, this may also include other
scheduled maintenance—for example, weekly and monthly maintenance.
e For information about maintenance items to be performed, refer to your laboratory
maintenance schedule and see the following maintenance chapters:
Chapter 13 General maintenance
Chapter 14, Maintenance schedules on page C-27

Analyzer shutdown and sleep mode

After routine operation is finished and all required maintenance has been performed,
the analyzer can be shut down. There are two options for analyzer shutdown:
o Complete shutdown
o Entering sleep mode

Shutdown In Shutdown status the analytical unit and the control unit are powered off. Only the
power for keeping reagents cooled is supplied.

Sleep mode During sleep mode most of the parts are powered off. Only the control unit, cooling
compartment and control board are powered on. The monitor is automatically
powered off to reduce power consumption when it is not used for a fixed period of
time. Move the mouse to wake up the monitor.
Sleep mode provides the possibility of an automatic start-up on the next day. This
way, the system can perform initialization and any programmed start up maintenance
items in the absence of an operator, before the beginning of a working session. When
the operator arrives, the analyzer is ready for operation.

Note that when the analyzer wakes up from sleep mode, the control unit performs a
shutdown to reset the PC operation software (Windows XP).

e For more information about checks after waking-up from sleep mode, see:
Start-up inspection on page B-30.

Perform one of the following procedures to shut down the analyzer after all required
daily maintenance has been performed.
e For information about the daily maintenance items that must be performed before
shutdown, see:
Daily manual maintenance on page C-32.

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Shutting down the analyzer

a To enter sleep mode

1 Verify the settings for the Sleep pipe function (Utility > System (Page 2/5) > Pipe
Setting).
e See Sleep Pipe function on page C-14.

2 Verify that provision is made for start-up on the next day. Verify the settings of the
Power Up pipe function (Utility > System (Page 2/5) > Power Up Pipe).
e See Power Up Pipe function on page C-13.

3 Choose Shut down (global button) to display the Shutdown window.

4 Select the Sleep option and choose OK.
The instrument is put into sleep mode until the specified wake up time. The wake-
up time is displayed.
5 Perform the regular checks after shutdown.
e See Checks after shutdown on page B-73.

The complete shutdown procedure should be performed at least once a week.

a To shut down the analyzer

1 Choose Shut down (global button) to display the Shutdown window.
2 Select the Shutdown option and choose OK to confirm the shutdown.
3 Wait until the screen goes completely black (computer has shut down).
4 Switch off the power switches of the monitor and printer.

If power to the analyzer is switched off prior to the complete shutdown of the computer,
the instrument may not start up properly when power is supplied again.

5 Switch off the power switch on the right side of the analytical unit.
6 Turn off the water supply, if necessary.
After shutting down the analyzer, check individual parts of the instrument according
to the given maintenance recommendations.
e See Checks after shutdown on page B-73.

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Shutting down the analyzer

Checks after shutdown

The checks and maintenance actions required after shutdown are the same as those
required before start-up.
e See Start-up inspection on page B-30.

If the analyzer has been set for automatic start-up, it is essential to perform all
required before start-up checks at the end of the previous working session; otherwise,
problems may occur.
Below is the list of conditions that are to be checked before start-up. Check that:

Control unit o There is no floppy disk in drive A.

o There is sufficient paper in the printer.

Analytical unit o The water supply is switched on.

o The container for highly concentrated waste is empty.
o There are no samples in the sample disk.
o All surfaces are clean and clear of loose articles. Clean up spills immediately using
a paper towel moistened with 70% ethanol.
o No tubing is pinched or bent.

Either before shutting down or after powering up, check that:

o Syringes are not leaking.
o Auxiliary reagents (cleaning solutions) required for start-up pipes are loaded.
o All empty reagents are removed and new ones loaded according to your daily
workload.

ISE unit o All electrode cables and tubings are correctly connected. Tubing is not leaking.

If a trouble occurs, take suitable measures according to the condition and contact
your Roche service representative.

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Shutting down the analyzer

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Table of contents

Orders and results

This chapter provides descriptions of special tasks that are not usually part of the
daily workflow. It is meant to complement the chapter Daily operation, where
everyday tasks and common procedures for running the cobas c 311 analyzer are
described.

In this chapter Chapter 7

Overview ................................................................................................................... B-77
Test Selection screen ................................................................................................. B-78
Test selection matrix ........................................................................................... B-79
Colors ............................................................................................................ B-79
Markings ....................................................................................................... B-80
Requesting a test manually ................................................................................ B-81
Requesting a test in barcode mode .............................................................. B-81
Requesting a test in non-barcode mode ...................................................... B-82
Performing manual reruns ................................................................................. B-84
Manual reruns in barcode mode ................................................................. B-84
Manual reruns in non-barcode mode ......................................................... B-85
Requesting manual reruns (barcode or non-barcode mode) .................... B-85
Entering unreadable sample barcodes ............................................................... B-86
Data Review screen ................................................................................................... B-88
Archiving patient data ........................................................................................ B-89
Editing or deleting sample data ......................................................................... B-90
Displaying archived patient data ....................................................................... B-92
Tracking samples on the analyzer ...................................................................... B-93

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Overview

Overview

The following sections describe tasks and data that can be accessed by the screens
under the workplace menu. The workplace menu comprises two screens: The
Workplace > Test Selection and the Workplace > Data Review screen.

Workplace > Test Selection Use this screen to enter test selections and demographics for a sample. The available
screen fields for sample identification vary, depending whether STAT or routine test
selections are being entered and whether the analyzer is operating in barcode mode or
not.
e For information on special operation procedures, see:
Requesting a test manually on page B-81
Entering unreadable sample barcodes on page B-86

Workplace > Data Review screen Use this screen to perform tasks related to reviewing and editing routine and STAT
results. Control results can also be viewed here. Other tasks that can be performed
from this screen include editing demographic information, sending data to the Host,
deleting data individually or in batches, backing up data and editing data.
e For information on special operation procedures, see:
Archiving patient data on page B-89
Editing or deleting sample data on page B-90
Displaying archived patient data on page B-92
Tracking samples on the analyzer on page B-93
e For a complete description of all fields and commands under the Workplace menu, refer to
the Online Help.

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Test Selection screen

Test Selection screen

To display this screen, choose Workplace > Test Selection.

Figure B-45 Test Selection screen

Use this screen to enter test selections and demographics for a sample. The available
fields for sample identification vary, depending whether STAT or routine test
selections are being entered and whether the analyzer is operating in barcode mode or
non-barcode mode.

Fields Barcode mode Non-barcode mode

(sequence mode)
Routine Stat Routine Stat
Sequence No. – – l –
Disk Pos. – – l l
(a) l(a)
Sample ID l l l
Table B-11 Test Selection screen - available fields for sample identification
(a) Recommended, but not required.

If test selections are downloaded from a Host, this screen is commonly not used.
e For more information about the different sample information fields and the buttons on
this screen, refer to the Online Help of the particular field or button.
e For information about the test selection matrix, see Test selection matrix on page B-79
e For information on special operation procedures, see:
Requesting a test manually on page B-81
Entering unreadable sample barcodes on page B-86

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Test Selection screen

Test selection matrix

A maximum of 160 test keys can be programmed on the analyzer. The test matrix has
32 keys in each group and up to 5 groups of test keys can be programmed on Utility >
System (Page 1/5) > Key Setting. One group at a time is displayed on the Test
Selection screen. Use the tabs above the test matrix to switch between the groups.
Group names are defined under Utility > System (Page 1/5) > Key Setting.
e For more information about Key Setting, refer to the Online Help.

Figure B-46 Test selection matrix

Colors
The test keys display different colors to indicate the status of the test for the sample ID
displayed in the Sample ID text box. The following colors are available:

This test has been selected.

This test has been performed, a result is available, and can be reordered again.

A rerun has been performed for this test and the result is available.

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Test Selection screen

Markings
One test or profile can be assigned to each key. The test keys display special markings
depending on the test's status or programming. The different markings and their
meanings are outlined below:

Blank test key indicates no test is assigned.

Normal test key for a test or profile without any masking indicators. The
reagent is on board of the analyzer and registered.
Mask (test channel or patient samples are masked)
o Test manually masked on the Masking window (Start (global button) >
Masking > T-Mask)
o Measurement of patient samples is manually masked (Start (global
button) > Masking > P-Mask). However, calibrations and controls can be
performed.
o The test can be requested. However, the test is performed only after the
test is manually unmasked.
o The test is not assigned to the analyzer in Utility > Module Set.
Reagent mask (no reagent available)
o Test is automatically masked by the analyzer. The volume of reagent, or
diluent, that is required for the respective test is either insufficient or the
reagent is not present on the analyzer. The test can be requested; however,
the test is performed only if a new reagent bottle or cobas c pack is placed
on the analyzer.
Calibration mask (calibration failed)
o Test is automatically masked by the analyzer due to a failed calibration
and the test requires a reagent cassette or lot calibration, or a new
application was added to the analyzer without performing a calibration.
The purple bar will not be displayed on the test key if:
o Calibration auto masking setting for the individual test is not selected on
Utility > Application > Calib.
o Calibration auto masking setting for the analyzer is not selected on
Utility > System (Page 2/5) > Calib Mask Setting.
Increased sample volume
o Test will run with an increased sample volume.
Decreased sample volume
o Test will run with a decreased sample volume.
Dilution
o Test will run with a dilution. The number after the triangle indicates the
ratio of the dilution (for example, 3is 1:3).
Profile
o A brown bar on the key indicates the key has been assigned to a profile.
When selected, all tests assigned to that profile are highlighted.

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Test Selection screen

Requesting a test manually

Tests can be manually selected for STAT and routine samples when the analyzer is in
either barcode or non-barcode mode.
This manual procedure is necessary if the test selection is not received from an
external system (host).

Requesting a test in barcode mode

a To request a STAT or routine sample

1 Load the sample onto the sample disk.
2 Choose Workplace > Test Selection.
3 Select the Stat or Routine option from the Sample area on the top left of the Test
Selection screen.
4 Type in the barcoded sample ID into the Sample ID text box and press Enter. The
Pre-dilution check box is active.
5 Select the Pre-dilution check box if the sample has already been diluted and press
Enter. The cursor moves to the Sample Cup box.

Samples which have been manually prediluted can be measured, but the corresponding
dilution factors are NOT taken into consideration when the results are calculated by the
analyzer. It is the operator's responsibility to calculate the final results.

6 Select the sample container type and press Enter. The cursor moves to the Sample
Volume / Dilution box.
7 Select the necessary dilution, if any, for the sample and press Enter. The cursor
moves to the test key.
8 Select the test, combination of tests, or test profiles for the sample. Selected tests
and profile keys appear white.
9 If necessary, type in demographic information about the sample and the patient,
such as the draw date, the sex and the age, and a comment.
10 Choose Save to save the test selection.
Completing the test selection for all samples, continue with To check and correct
registered tests and to start analysis on page B-81.

a To check and correct registered tests and to start analysis

After all test selections have been registered, we recommend checking the test
selection.
1 Print the Requisition list (Print (global button) > Workplace > Requisition List)
or check the registered tests on the screen as described in the following.
2 In the Test Selection screen, type in the sample ID number of the first sample in
the sample ID text box.
3 Check the registered tests:
o Choose Next to display the next sample without correction.
o Or correct the selected tests. Choose Save to save the corrected test selection.
4 Repeat the above procedure up to the last sample to be checked.
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Test Selection screen

5 Start analysis.
e For information on start of analysis, see
Starting the measurement on page B-58

Requesting a test in non-barcode mode

a To request a STAT or routine sample

1 Load the sample onto the sample disk.

Incorrect results due to sample mismatch

When operating in non-barcode mode, make sure to register the samples according to the
CAUTION loaded positions. The registered tests and sample positions can also be checked by
printing a Requisition list (Print (global button) > Workplace > Requisition List).

2 Choose Workplace > Test Selection.

3 Select the Stat or Routine option from the Sample area on the top left of the Test
Selection screen.
4 When requesting routine samples, type in the sequence number for the sample in
the Sequence No. text box and press Enter. The cursor moves to the Disk Pos. text
box.
5 Type in the position for the sample in the Disk Pos. text box and press Enter. The
cursor moves to the Sample ID text box.
6 Type in the sample ID into the Sample ID text box (recommended) and press
Enter. The cursor moves to the Pre-dilution check box.
7 Select the Pre-dilution check box if the sample has already been diluted and press
Enter. The cursor moves to the Sample Cup box.

Samples which have been manually prediluted can be measured, but the corresponding
dilution factors are NOT taken into consideration when the results are calculated by the
analyzer. It is the operator's responsibility to calculate the final results.

8 Select the sample container type and press Enter. The cursor moves to the Sample
Volume / Dilution box.
9 Select the necessary dilution, if any, for the sample and press Enter. The cursor
moves to the test key.
10 If necessary, type in demographic information about the sample and the patient,
such as the draw date, the sex and the age, and a comment.
11 Select the test, combination of tests, or test profiles for the sample. Selected tests
and profile keys appear white.
12 Choose Save to save the test selection.
Completing the test selection for all samples, continue with To check and correct
registered tests and to start analysis on page B-83.

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Test Selection screen

a To register a specific test selection to multiple samples

This option is only available in non-barcode mode.
1 Carry out all steps in one of the two procedures above.
2 Choose Repeat to open the Repeat Test Selection window.

Figure B-47 Repeat Test Selection window

3 Type in the number of samples for repeating the test selection in the Repeat Count
text box.
4 Choose OK.

In the Repeat operation, demographic data are not copied. When the demographic data
are necessary, they have to be entered with each sample ID after collective entry.

a To check and correct registered tests and to start analysis

When operating in non-barcode mode, you must confirm that all samples are loaded
to their registered positions.
1 In the Test Selection screen, note the first sequence number from which analysis is
to be started. This number must be entered into the Start Conditions screen.
2 Print the Requisition list (Print (global button) > Workplace > Requisition List)
or check the registered tests on the screen as described in the following.
3 In the Test Selection screen, type in the first sequence number in the Sequence No.
text box.
4 Check the registered tests:
o Choose Next to display the next sample without correction.
o Or correct the selected tests. Choose Save to save the corrected test selection.
5 Repeat the above procedure up to the last sample to be checked.
6 Choose Start (global button).
7 Type the first sequence number from which analysis is to be started in the Start
Sample No. text box in the Start Conditions screen.
8 Start analysis.
e For information on start of analysis, see
Starting the measurement on page B-58

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Test Selection screen

Performing manual reruns

Samples can be manually selected for rerun if a single test result is flagged with a data
alarm. Even if a result is not flagged with a data alarm, it may sometimes be desirable
to verify a result by a rerun.
This manual procedure is necessary if the Automatic Rerun setting in the Start
Conditions screen is disabled.
e For general information about reruns, see:
Automatic reruns on page B-62.

Manual reruns in barcode mode

The analyzer software provides several ways to perform a manual rerun in barcode
mode, as shown in the following table.

Case Automatic Instrument Description

rerun(a) status
1 NO Sampling Request a manual rerun using the Rerun Assignment
Pause or window, see To request a manual rerun using the Rerun
S.Stop Assignment window on page B-85.
2 NO Standby Request a manual rerun like a normal test request (using
the Test Selection screen), see Requesting a test in barcode
mode on page B-81.
Advantages: The positions of barcoded samples can be
changed for rerun. New samples can be measured at the
same time if already completed samples are removed from
the sample disk. You can change the sample volume or
request a dilution for rerun.
3 YES If 3rd Results Acceptance is enabled (Utility > System
screen), a manual rerun can be performed to receive a third
result.
The first and second (auto rerun) result must have been
transmitted to host before. Use one of the methods
described in case 1 or 2 to request a manual rerun.
Table B-12 Possibilities of manual rerun in barcode mode
(a) Setting on the Start Conditions screen.

e For information about 3rd Results Acceptance, see:

Generating multiple results for a single test on page B-195.

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Test Selection screen

Manual reruns in non-barcode mode

The analyzer software provides two ways to perform a manual rerun in non-barcode
mode, as shown in the following table.

Case Automatic Instrument Description

rerun(a) status
1 NO Sampling Request a manual rerun using the Rerun Assignment
Pause or window, see To request a manual rerun using the Rerun
S.Stop Assignment window on page B-85.
2 NO Standby Request a manual rerun like a normal test request (using
the Test Selection screen), see Requesting a test in non-
barcode mode on page B-82.
In the Test Selection screen, note the first sequence number
from which the rerun is to be started. This number must be
entered into the Start Conditions screen.
Advantage: You can change the sample volume or request a
dilution for rerun.
Table B-13 Possibilities of manual rerun in non-barcode mode
(a) Setting on the Start Conditions screen.

Requesting manual reruns (barcode or non-barcode mode)

a To request a manual rerun using the Rerun Assignment window

1 Make sure that the analyzer is in Sampling Pause or S.Stop status. Choose Pause
(global button) if the analyzer is in Operation status.
2 Choose Workplace > Data Review.
3 Select one sample that requires a manual rerun.
4 Choose Workplace > Test Selection.
5 Choose the Rerun Assignment button to request a manual rerun for this sample.

Figure B-48 Rerun Assignment window (barcode mode)

6 Choose Add in the Rerun Assignment window to add this sample to the Manual
Rerun List in the bottom of this window.
7 Choose OK to close the Rerun Assignment window.

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Test Selection screen

8 On the Test Selection screen, select the tests that require a manual rerun.
The color of a selected test key changes from yellow to white (manual rerun) or
from gray to white (3rd result). Tests may also be added which have not been
measured before.
9 Choose Save on the Test Selection screen.
10 Repeat the above procedure up to the last sample that requires a rerun.
11 Choose Start (global button).
12 Choose Start to initiate the rerun.
When pipetting of a rerun sample begins, this sample will be deleted from the
Manual Rerun List.

If a sample listed in the Manual Rerun List is not placed on the sample disk, this request
will be deleted.

Entering unreadable sample barcodes

The barcode label must be attached in such a way that it is visible through the notch
between the sample cup positions.

A Sample tube (100 mm) B Notch between sample cup positions

Figure B-49 Samples on the outer ring with their barcode facing outwards

For a sample without a barcode, or an unreadable barcode an extra registration step is

necessary. The sample with the barcode read error is marked with in the Sample
Tracking window.

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Test Selection screen

a To enter an unreadable sample barcode

1 Choose Workplace > Test Selection.
2 Choose Barcode Read Error.

Figure B-50 Barcode Read Error window

3 Select Stat or Routine in the Sample area and press <Enter>.

4 Select the sample material from the Type list box and press <Enter>.

Incorrect results due to position mismatch

Check the manually entered ID against the sample ID on the sample container.
CAUTION Make sure that the samples are loaded in the correct position on the sample disk.

5 Type the position in the Disk Pos. text box and press <Enter>.
6 Type the sample ID of the sample in the Sample ID text box and press <Enter>.
7 Choose Add. The sample type, position, and sample ID are displayed.
8 Repeat steps 3 to 7 for any further samples with a barcode read error.
9 Choose OK.

If you have entered an unreadable barcode before scanning, the analyzer automatically
deletes the disk position assignment and no measurement will be performed.

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Data Review screen

Data Review screen

To display this screen, choose Workplace > Data Review.

Figure B-51 Data Review screen (barcode mode)

Use this screen to perform tasks related to reviewing and editing routine and STAT
results. Control results can also be viewed here.
Other tasks that can be performed from this screen include editing demographic
information, sending data to the Host, editing, and deleting data individually or in
batches, backing up data.

Status column The St. column displays the sample status codes.

O (Ordered) Sample registered by user or Host.

P (Processing) Sample is being processed.
I (Incomplete) Sample is processed, but a data alarm is present.
No symbol (Complete) Sample is successfully processed (no alarm present).
H (Sent to Host) Sample results have been sent to the Host.

The status incomplete does not apply to control samples.

Disk column This column displays the disk position number (001-108) of the current sample. It
also shows how the sample was run, using the following code:

Code Sample
N Routine (normal sample)
E STAT (emergency sample)
C QC (control sample)
Table B-14 Disk position codes in the Data Review screen

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Data Review screen

e For more information about the different sample information fields and the buttons on
this screen, refer to the Online Help of the particular field or button.
e For information on special operation procedures, see:
Archiving patient data on page B-89
Editing or deleting sample data on page B-90
Displaying archived patient data on page B-92
Tracking samples on the analyzer on page B-93

Archiving patient data

Use this function to make backup copies of test results on a DVD (when operating
without a Host or for a backup additionally to the Host).

a To archive patient data

1 Choose Workplace > Data Review.
2 Select the samples for which data is to be backed up from the list on the left of the
Data Review screen.
3 Choose Backup Data to display the Backup Data window.

Figure B-52 Backup Data window

4 Insert a DVD into the DVD drive.

5 Type the name to be given to the file in the File Name text box (up to eight
characters).
6 Select the format in which the data is to be written, ASCII or Binary, and select the
Base Data or All Data option in the File Format area.

o ASCII files can be read by other PC systems, but cannot be reloaded into the
cobas c 311 analyzer.
o Binary files can be reloaded into the cobas c 311 analyzer (Workplace > Data
Review > choose Backup Media from the data list box), but cannot be read by other
PC systems.
o Base Data will only save the measurement results and the data alarms.
o All Data will additionally save the units of the measurement results and the sample
volume/dilution ratio.

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Data Review screen

7 Choose OK to back up the selected data after confirmation. The Save Data
window is displayed. This closes after the data has been backed up.
e For applicable DVD media types, see: Control unit on page A-71.

Editing or deleting sample data

Sample data displayed on the Data Review screen can be edited or deleted if required.
Use the following procedures to edit or delete sample data.

a To select a result to be edited or deleted

1 Choose Workplace > Data Review.
2 Select the data source, Routine View or Backup Media, from the list box in the
Data Area from which the sample data is to be reviewed.

QC View is also available as an option in the list box in the Data area, but this view displays
only QC data.

e For information on using a Backup Disk, see Displaying archived patient data on
page B-92.

3 Select a sample from the list on the left of the screen. The results, 1st and Rerun, of
the tests performed on this sample are displayed in the list on the right of the
screen.
4 Choose Test Review to display the Test Review window. This window displays
more information on the test results.

Figure B-53 Test Review window

5 Select the test result in the Data column. The result is activated (blue background)
and highlighted white.

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Data Review screen

a To edit sample data

Edited test results will always be flagged.

1 Select the test result to be edited.

2 Enter the new result (the old result is overwritten) and press <Enter>. The
Updated button turns yellow.
3 Choose Update to save the changes or Cancel to reset the entry to the original
value.

a To delete sample data

1 Select the test result to be deleted.
2 Choose Delete Test to delete the test after confirmation.

a To delete a sample
1 Choose Workplace > Data Review.
2 Select an individual sample, or a number of samples, to delete from the list on the
left of the screen.
3 Choose Delete Record to delete the sample(s) selected after confirmation.

When a QC sample is deleted, this will be transferred to the QC View Database. To delete
this you have to delete the QC sample from the QC View Database.

The Sample Count is unchanged after a record has been deleted. To delete all records, use
Delete All. This will reset the sample count to 0.

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Data Review screen

Displaying archived patient data

Only data saved in binary format can be reloaded onto the control unit.
e See Archiving patient data on page B-89

Reloaded data can only be viewed on the Data Review screen.

Mismatching versions of analyzer system software

Patient data written by a newer version cannot be read onto an analyzer with an older
version of system software.

a To display archived patient data

1 Select Backup Disk from the Data list box on the Workplace > Data Review screen
to display the Read Back Up Disk window.

Figure B-54 Read Backup disk window

2 Insert the DVD into the DVD drive.

3 Type the file name in which the data is saved in the File Name text box.
4 Choose OK. The saved data is displayed on Workplace > Data Review.

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Tracking samples on the analyzer

o Only STAT and routine samples can be searched for in the Sample Tracking window.
o The location of a sample is only indicated on the Sample Tracking window once a
sample has been scanned.

a To track a sample on the analyzer

1 Choose the graphical icon representing the analyzer in the status line (top left of
the screen) to display the System Overview screen.
2 Choose Sample Tracking to display the Sample Tracking window.

Figure B-55 Sample Tracking window

3 Choose Sample Search to display the Sample Search window.

Figure B-56 Sample Search window (non-barcode mode)

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Data Review screen

4 Choose the Stat or Routine tab, depending on what kind of sample you are
searching for.
5 Select one of the following search options (e.g., to search by sample type):
o Sample type
o Sample ID (barcode mode only)
o Sequence No. (non-barcode mode only)
o Disk position (non-barcode mode and STAT only)
o Main comment
6 Choose OK.
The samples that match the search criteria will be marked in the graphics
representing the sample disk.
e For information about the Position Status area, see:
Position status on page B-66.

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Table of contents

Reagents

This chapter describes all types of reagents used on the cobas c 311 analyzer. It
provides information about the system’s reagent management as well as detailed
information on how the operator can monitor the status of loaded reagents
(operator-related reagent management).

In this chapter Chapter 8

Reagent concept ........................................................................................................ B-97
Reagents for ISE applications ............................................................................. B-97
Reagents for photometric applications ............................................................. B-99
Diluents ......................................................................................................... B-99
Auxiliary reagents and detergents .............................................................. B-100
Calibrators and controls ............................................................................. B-101
cobas c packs ........................................................................................................... B-101
Barcode label ..................................................................................................... B-102
Handling of reagents .............................................................................................. B-103
ISE reagent registration .................................................................................... B-103
Notes on replacement of ISE reagents ............................................................. B-103
Reagent registration ......................................................................................... B-104
Remaining volume control .............................................................................. B-104
Unloading and reloading cobas c packs .......................................................... B-104
Carryover evasion ............................................................................................. B-105
Reagent screen overview ........................................................................................ B-106
Reagent Setting screen ............................................................................................ B-107
Reagent Status screen ............................................................................................. B-108
Replacing auxiliary reagents ............................................................................ B-109
Reagent Overview button ...................................................................................... B-111
Reagent Overview window .............................................................................. B-111

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Table of contents

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cobas c 311 analyzer 8 Reagents
Table of contents

Reagent concept

Reagents This section provides information about reagents used on the cobas c 311 analyzer,
how they are used for ISE applications and photometric applications. It describes the
reagent containers and explains how the analyzer registers new reagents and how it
monitors reagent consumption.

Reagents for ISE applications

This section describes all reagents necessary to run the cobas c 311 analyzer’s ISE unit
and the reagents that are specific for each available ISE application. The following ISE
applications are available:

ISE applications ISE applications

Potassium serum/plasma Potassium urine
Sodium serum/plasma Sodium urine
Chloride serum/plasma Chloride urine
Table B-15 List of ISE applications

Reference information for ISE The following table compiles reference information for all ISE reagents, such as
reagents auxiliary reagents, calibrators, and controls.

Product name Short name(a) Containers on the Localization or

analyzer code
Reagents for measurements ISE Internal Standard Gen.2 ISE IS 1 bottle of 600 mL ISE reagent
ISE Diluent Gen.2 ISE Dil. 1 bottle of 300 mL compartments

ISE Reference Electrolyte ISE Ref. 1 bottle of 300 mL

Calibrators(b) ISE Standard low ISE Low Cup or cup on 502
ISE Standard high ISE High tube(c) 503
ISE Compensator (global use) ISE Comp. 504
ISE Standard high ISE High (compensated) 763
(compensated) (use in US only) (use in US only)
Quality controls Precinorm U / Precinorm U Plus PNU / PNU Plus Cup or cup on 300
Precipath U / Precipath U Plus PPU / PPU Plus tube(c) 301
(d)
Auxiliary reagents for maintenance ISE cleaning solution SysClean Cup or cup on Position W1
ISE Activator Activator tube(c) or tube Position W2
Table B-16 ISE reagents
(a) used in this documentation
(b) The calibration interval is 24 hours for all ISE applications. Calibrators are also named standards.
(c) Hitachi cup or cup on standard tube in the sample disk, see Sample cups and tubes on page A-75.
(d) For washing of ISE electrodes (maintenance item (10) ISE Wash).

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Table of contents

Reagents for measurements Each ISE measurement uses the following reagents:
o Internal standard (ISE IS), used for one-point calibrations performed before and
after each sample determination
o Reference solution (ISE Ref.), used for reference electrode measurements
o Diluent (ISE Dil.), used for 1:31 dilution of sample
ISE auxiliary reagents (ISE IS, ISE Ref., ISE Dil.) are supplied in reagent bottles and
do not use a barcode for registration. ISE auxiliary reagents are to be replaced only
when the instrument is in Maintenance mode or in Shutdown status.
After the replacement of ISE IS or ISE Ref., a Reagent Prime is required to fill the flow
path with the new liquid. After this an ISE calibration is required to calibrate the ISE
unit.
e For more information about replacement of ISE reagents, see:
ISE reagents on page B-42.

Calibrators The following ISE calibrators are used depending on the calibration method:
o Std (1) or S1: ISE Low, a water-based solution
o Std (2) or S2: ISE High, a water-based solution
o Std (3) or S3:
o For global use: ISE Comp., a serum-based solution, used for blank
calibrations, full calibrations as well as for conditioning the electrodes
o For use in US only: ISE High (compensated) with compensated set points is used
for full calibrations.
The calibration interval for all ISE applications is 24 hours.

Quality controls The following products are used for quality controls:
o PNU or PNU Plus
o PPU or PPU Plus
Quality controls can be used either with barcode or without. The operator can decide
whether to use barcodes, change the settings in the software if necessary (Barcode
Setting area on Utility > System), but then has to stick to the respective mode for QC
measurements.

Do not put barcoded sample tubes to assigned positions for calibrators or quality controls.
Be consistent with the software settings (Position Assignment under Calibration >
Calibrator and under QC > Control).

e For more information on ISE reagents, see:

ISE reagent registration on page B-103
ISE reagents on page B-42.

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Reagent concept

Reagents for photometric applications

This section describes all reagents necessary to run the photometric unit. It provides
an overview of diluents, auxiliary reagents (such as basic and acid detergents), as well
as calibrators and controls.

Diluents

Short name Long name Comment

NaCl NaCl 9% Diluent for photometric tests
A1CD2 Hemolyzing Reagent Gen.2 Diluent for HbA1c whole blood test
Table B-17 Diluents for photometric tests

NaCl For photometric applications, either water or a NaCl solution is used as diluent. The
water is deionized water from the analyzer’s water tank. NaCl solution is supplied in
cobas c packs NaCl 9%. The following general rules apply:
o Water is used for all blank calibrations.
o NaCl solution is used for all sample dilutions. Whenever used as diluent, the 9%
solution from the cobas c pack is diluted with water to a concentration of 0.9% by
the analyzer.

Make sure you have sufficient diluent on the analyzer—especially if a higher demand of
diluent can be expected.

A1CD2 The diluent for HbA1c whole blood tests is also supplied in a cobas c pack.
e For information about the HbA1c whole blood application, see:
Loading the HbA1c Whole blood application on page B-176.

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Reagent concept

Auxiliary reagents and detergents

The analyzer uses the following auxiliary reagents and detergents:

Product name Short Description Containers on the Localization

name(a) analyzer
Cell Wash Solution I / Cell wash I NaOH-D, used for rinsing and cleaning of reaction 1 bottle of 1.8 L Behind the
NaOH-D cells left front door
Cell Wash Solution Cell wash II Acid wash, test specific, used for rinsing and 1 bottle of 2.0 L
II / Acid Wash cleaning of reaction cells
Multiclean Multiclean Sample probe wash solution 1, NaOH 1 mol/L 1 bottle of 70 mL Near sample
SMS / Acid Wash SMS Sample probe wash solution 2, 200 mmol/L HCl 1 bottle of 70 mL probe

Hitergent Hitergent Surfactant for incubator bath to prevent algae 1 cobas c pack of Reagent disk
proliferation and foaming 50 mL
NaOHD NaOH-D Detergent 1 for special washes (carryover evasion, 1 cobas c pack of Reagent disk
reagent probe and cell wash, if necessary) and cell 50 mL
wash (Maintenance item (6) Wash Reaction Parts)
SMS SMS Detergent 2 for special washes (carryover evasion, 1 cobas c pack of
reagent probe and cell wash, if necessary) 50 mL
Table B-18 Photometric auxiliary reagents and detergents
(a) used in this documentation

e To locate these reagents and detergents on the analyzer, see:

Behind the front doors on page A-63
Sampling area components on page A-36
e For information about replacing detergents and reagents, see:
To load a cobas c pack on page B-45
To replace a cell detergent bottle on page B-109
To replace a sample probe detergent bottle on page B-109
e For information about special washes, see:
Special Wash on page B-209

Remaining volume control for The remaining volumes of the diluent and the auxiliary reagents are monitored by
reagent bottles countdown, starting from a given initial volume. The remaining volumes are
displayed on the Reagent > Status screen. Whenever a reagent bottle is replaced, the
operator has to reset the initial volume. Reagent registration is not performed
automatically whenever a new bottle is placed on the analyzer.
e For more information on monitoring the reagent status, see:
Reagent Status screen on page B-108
To reset initial volumes of auxiliary reagents on page B-110

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cobas c packs

Calibrators and controls

For photometric applications, there are universal calibrators and special calibrators
available. The same universal calibrator is used for a large number of applications
where as a special calibrator covers only a few or only one application.
Universal calibrators are Cfas (without diluent) or Cfas Proteins.
Likewise, there are universal and special controls.
Universal quality controls are PNU / PNU Plus and PPU / PPU Plus.
e For information about calibrators and quality control reagents for specific applications,
refer to the respective package inserts.

Most of the calibrators and controls have to be reconstituted and pipetted into cups.

cobas c packs

Apart from a number of reagent bottles for auxiliary reagents, the principal reagent
container is the cobas c pack (COBAS INTEGRA cassettes can also be used).

All information about cobas c packs in this manual also applies to COBAS INTEGRA
cassettes.

In addition to the cobas c packs and COBAS INTEGRA cassette types, there is the
cobas c pack MULTI, which is an empty barcoded cobas c pack. These kits are used
for development channel applications and lyophilized reagents, which have to be
mixed with solvent just prior to use. To prepare a cobas c pack MULTI for use on the
analyzer follow the instructions given in the package insert.

Figure B-57 cobas c pack with position designations

A cobas c pack can contain up to three reagent bottles. The center position is
position A. With the barcode facing to the rear, the left position is position B and the
right position is position C. Pipettings at different timings (R1, R2, or R3) are not
restricted to any position.

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cobas c packs

Barcode label

Each cobas c pack or other cassette is equipped with a barcode label. The analyzer
scans this barcode label each time a cassette is loaded onto the analyzer at the reagent
loading station.

Incorrect results due to incorrect placement of reagent

If a cobas c pack (or COBAS INTEGRA cassette) is inserted the wrong way around,
CAUTION reagents will be pipetted in the wrong order, leading to incorrect results. The instrument
may also be damaged.
When inserting the cobas c pack, make sure the barcode is facing the barcode reader.

The following data are encoded on the barcode label:

o System ID (for example, 07-3755-0)
o Lot number
o Cassette number (serial number, for example, 01983)
o Expiration date
o Bottle configuration information (on cobas c packs only)

If the barcode of a cobas c pack or other cassette is unreadable, this cassette is not
accepted. The operator is requested to close the gate.

e For information about the registration of reagents, see

Reagent registration on page B-104.

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Handling of reagents

Handling of reagents

This section describes how the analyzer registers reagents and how it keeps track of
the remaining volumes of reagents in the course of their consumption. The unloading
and reloading of reagents is explained. The last sub-section covers carryover evasion.

ISE reagent registration

ISE IS and ISE Dil. are stored in reagent bottles in one of the ISE reagent
compartments. At analyzer startup, the remaining volume is checked for those ISE
reagents. The reagent pipetter probe is equipped with a level detector (capacitance
method), which monitors the liquid level in the reagent bottles.
The ISE Ref. reagent bottle is not equipped with a level detector. The remaining
volume of ISE Ref. is counted down with each test.
When you replace a reagent bottle, you have to reset the remaining volume manually.
After replacement, the liquid level is not detected. Therefore, use only new bottles for
replacement. When the first test is selected after replacement, the remaining volume
will be updated. The Reagent Overview screen displays the present remaining volume
of each reagent (System Overview > Reagent Overview screen).
If the ISE IS or ISE Dil. bottle is not on board at analyzer startup or if the liquid level
falls below the limit where the bottle needs to be replaced, a yellow alarm (Reagent
Short) is issued on the Alarm screen. The AU Unit and the Reagent Overview button
turn red.
When the number of available tests is “0”, all ISE tests will be masked and thus no
subsequent measurement is possible.
e For instructions on how to replace ISE reagents, see ISE reagents on page B-42.

Notes on replacement of ISE reagents

Be sure to observe the following safety precaution:

o Incorrect results due to expired reagents or mixing reagents on page B-4

o Make sure bubbles do not form in the ISE IS and ISE Dil. bottle. If bubbles form,
reagent level may not be detected correctly by liquid level detection.
o ISE reagents are to be replaced only when the instrument is in Maintenance mode
or in Shutdown status.
o Make sure that you place the reagents in their correct positions (refer to labels on
the analyzer).
o For ISE Ref., make sure that the end of the tube touches the bottom of the bottle.
Otherwise, reagent may not be pipetted properly.
o After replacing an ISE IS or ISE Ref. bottle, reagent priming must be carried out to
fill the flow path with the new liquid.
o Whenever replacing any ISE reagent, perform an ISE calibration before you
resume routine operation.

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Handling of reagents

Reagent registration

In order to register a new cobas c pack (or other cassette) the analyzer must read the
information stored on the barcode label. The operator clicks the Loading button in
the Reagent Setting screen and the analyzer unlocks the gate. The operator opens the
gate and scans the barcode label. After the cobas c pack is accepted, the operator
places the cassette in the reagent loading station.
e For information about the reagent loading station, see
Reagent loading station on page A-46.

If the cobas c pack currently being scanned has not been on the analyzer before, the
analyzer proceeds with the following actions:
o The analyzer registers the initial capacity (set by application parameters).
o The piercer pierces the caps of the bottles in the cobas c packs.
o The reagent pipetter probe performs an initial volume check—also referred to as
initial cassette volume check (ICVC)—for each of the bottles in the cobas c pack,
if this ICVC option has been selected.
Note that an ICVC is only required for COBAS INTEGRA cassettes. For cobas c packs
this option is deselected.

Remaining volume control

After a cobas c pack has been registered the analyzer counts every pipetting out of this
cassette. Thus, the cassette’s initial number of available test is counted down. When
the number of remaining tests is lower than a defined limit, an alarm is issued (yellow
or purple alarm, according to configuration under Utility > System > Reagent Level
Check). When the number of remaining tests becomes zero, an alarm is issued (red
alarm) and the test is masked.
e For more information on monitoring the reagent status, see:
Reagent Status screen on page B-108

Unloading and reloading cobas c packs

The analyzer counts down each cassette’s initial number of available tests with every
pipetting out of that cassette. The thus obtained number of available tests is stored by
the analyzer for up to 3000 cobas c packs. If you unload a cobas c pack and reload it
later, the analyzer recognizes the cassette and continues the test count at the point
where it was unloaded.

Incorrect results and interruption of analysis due to false reagent volumes

Reload a cobas c pack only if you are sure the reagent volumes remained unchanged
CAUTION while it was not on the analyzer.
Never load a used cobas c pack onto another analyzer.

When reloading a cobas c pack onto the same analyzer, the analyzer does not perform
a second volume check—like the initial cassette volume check (ICVC) when the
cassette was new. It is assumed that the cassette’s reagent volumes remain unchanged
while the cobas c pack is not on the analyzer.
e For further instructions, see Unloading cobas c packs on page B-47

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Handling of reagents

Carryover evasion

Even though all pipetter probes and reaction cells are washed and rinsed thoroughly
after each use, it could be possible that traces of sample liquid or reagent remain on
contacted parts (probes or reaction cells) and are carried over at the next pipetting.
By means of the special wash function, the cobas c 311 analyzer prevents traces of
sample liquid or reagent of one test from being carried over to another test and bias
the result of the latter.
e A current carryover evasion list is available on cobas link. Refer to the important note for
NaOHD / SMS / Multiclean.
e For more information on programming special washes, see:
Programming a reagent probe wash on page B-209
Programming a cell wash on page B-211
Programming a sample probe wash on page B-212

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Reagent screen overview

Reagent screen overview

Reagents The following sections describe tasks and data that can be accessed by the screens
under the reagent menu. The reagent menu comprises two screens: The Reagent >
Setting screen and the Reagent > Status screen. In addition, the Reagent Overview
button on the System Overview screen as well as windows accessed via this button are
explained.

Reagent > Setting screen The Reagent > Setting screen provides detailed information about each test reagent
and position. The compiled data include the numbers of available and remaining
tests, reagent codes, lot numbers, sequence numbers, expiration dates (shelf-life) as
well as on board stability of reagents (in days). The following tasks can be performed
from this screen:
o Loading and unloading cobas c packs
o Reagent level reset of ISE reagents
o Priming ISE reagents
o Registration of Development Channel reagents

Reagent > Status screen The Reagent > Status screen provides all important data about test reagents to
monitor the reagent status on the analyzer. The data are sorted according to the
names of the applications. Moreover, there is an additional list, which provides
information about auxiliary reagents. The following task can be performed from this
screen:
o Resetting the remaining volume control for auxiliary reagents
e For a complete description of all fields and commands under the Reagent menu, refer to
the Online Help.
e For more information, see:
Reagent Setting screen on page B-107
Reagent Status screen on page B-108

System Overview > Reagent By changing its color, the Reagent Overview button indicates potentially insufficient
Overview button amounts of reagent. Choose this button to view details about the status of loaded
reagents.
e See Reagent Overview button on page B-111.

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Reagent Setting screen

Reagent Setting screen

To display this screen, choose Reagent > Setting.

Figure B-58 Reagent Setting screen

This screen comprises a large test list and several buttons.

e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

Loading Choose this button to load cobas c pack.

e For more information, see Loading cobas c packs on page B-45.

Reagent Level Reset Choose this button to reset the initial volume of ISE reagents.
e For more information, see:
To replace ISE IS or ISE Dil. on page B-43
To replace ISE reference solution (ISE Ref.) on page B-44

Reagent Prime Choose this button to prime reagents of the ISE unit. Both ISE IS and ISE Ref can be
primed.
e For more information on replacing and priming ISE reagents, see:
ISE reagents on page B-42
To perform a Reagent Prime on page B-44.

Unloading Choose this button to unload a cobas c pack.

e For more information, see Unloading cobas c packs on page B-47.

Development Channel Choose this button to reserve a Development Channel application to be assigned to a
cobas c pack MULTI.

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Reagent Status screen

Reagent Status screen

To display this screen, choose Reagent > Status.

A Test list
B Reagent list
C Auxiliary reagent list (for photometric assays only)

Figure B-59 Reagent Status screen

The Reagent > Status screen displays reagent data for all tests on the analyzer. The
screen comprises a test list, a detailed reagent list (on the top right), and auxiliary
reagent list (on the bottom right).
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

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Reagent Status screen

Replacing auxiliary reagents

When replacing auxiliary reagent bottles (such as cell detergent or sample probe
detergent bottles), you have to manually reset the software’s reagent volume count.

o A detergent whose valid term has expired must not be used. Otherwise, measurement
may fail to achieve a correct result.
o Avoid adding a new detergent to the old one. Otherwise, measurement may fail to
achieve a correct result.

Follow the procedures below to replace auxiliary reagent bottles and reset their
volume count:

a To replace a cell detergent bottle

1 Make sure that the analyzer is in Standby.
2 Open the front door of the analyzer.
3 Replace required reagent bottle and clean the aspiration filter.
e See M11: Cleaning the detergent aspiration filters on page C-68.

Incorrect results due to incorrect insertion of the cell detergent aspiration tube
If the aspiration tube is not inserted correctly, the detergent may not be dispensed
CAUTION properly. This may lead to incorrect results.
o Insert the aspiration tube so that the end of the tube touches the bottom of the bottle.
o Do not bend the aspiration tube.

4 Perform maintenance item (8) Cell Detergent Prime from the Utility >
Maintenance screen.
5 Reset the volume count under Reagent > Status > Inventory Set.
e See Resetting initial volumes of auxiliary reagents.

a To replace a sample probe detergent bottle

1 Make sure that the analyzer is in Standby.
2 Put the analyzer in Maintenance mode.
3 Unlock and open the top cover of the analyzer.
4 Replace required reagent bottle. Two kinds of 70 mL bottles can be used.
Multiclean and SMS bottles must be placed on detergent positions 1 and 2
respectively.
5 Reset the volume count under Reagent > Status > Inventory Set.
e See Resetting initial volumes of auxiliary reagents.

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Reagent Status screen

Resetting initial volumes of The remaining volumes of cell detergents and other auxiliary reagents are monitored
auxiliary reagents by counting down from the initial volume of a full reagent bottle. When you place a
new reagent bottle, you always have to manually reset this volume countdown.

Always replace empty detergent bottles with new and full ones. Otherwise the volume
cannot be correctly determined.

a To reset initial volumes of auxiliary reagents

1 Select the reagent from the auxiliary reagents list (on the bottom right) whose
volume needs to be reset.
2 Choose Inventory Set.
3 Choose OK to confirm the reset.

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Reagent Overview button

Reagent Overview button

By changing its color, the Reagent Overview button in the System overview screen
indicates potentially insufficient amounts of reagent. It also indicates when QC results
are out of range and if there is no valid calibration available:

Button in Overview area Color Meaning

Red A reagent is empty and there is no second cobas c pack on this
Reagent Overview
analyzer.

Yellow The number of tests remaining for a reagent is below the yellow
alarm threshold (caution level).
For ISE reagents, the remaining volume is below the yellow alarm
threshold (caution level).
Table B-19 Colors of Reagent Overview button in Overview area of System Overview screen

Choose the Reagent Overview button to display the Reagent Overview window. This
window displays an overview of the consumables currently loaded on the analyzer.

Reagent Overview window

Choose System Overview > Reagent Overview to display this screen. It consists of
three areas, the Reagent area, Inventory area, and ISE area.

A
B
C

A Inner subring: Cas (Cassette) D Remaining volumes of cleaner solutions

B Middle subring: Cal (Calibration) E Remaining volumes of ISE reagents
C Outer subring: QC (Quality Control)

Figure B-60 Reagent Overview window

A reagent mandatory message is displayed on the Reagent Overview screen when the
analytical unit is shown red on the System Overview screen. This may occur if a mandatory
reagent is not on board.
This function is available only, if the test of the missing reagent has been defined as
mandatory under the Utility > Module Set > Test Assignment.

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Reagent Overview button

Reagent area Use this area to view the status of the cobas c packs loaded on the analyzer. This area
comprises a graphic representing the reagent disk and a legend.
The graphic is divided into 2 large rings. The 14 segments of the inner large ring and
the 28 segments of the outer large ring represent the 42 positions for cobas c packs.
Each of the segments is subdivided into 3 subrings. The colors of each segment
correspond to the following statuses:

o Cas: Reagent status (inner subring)

o Cal: Status of the calibration (middle subring)
o QC: Status of the QC (outer subring)
Choosing a segment displays detailed information about the cobas c pack (Position,
Status, Test Name and Available Tests) in the center of the graphic.

Legend of the Reagent area The legend at the bottom of the Reagent area explains the colors represented in the
sections of the reagent disk graphic.
1. Inner subring: Cas (Cassette)

Active Reagent currently in use for this test.

Warning Remaining tests in this cobas c pack below yellow alarm level
(Utility > System (Page 2/5) > Reagent Level Check).
Zero tests, Used up The cobas c pack has been used up and is empty. There is still
reagent available in another cassette on this analyzer.
Caution There is no more reagent available for this assay on this
analyzer.
Stand-by This is a standby cassette.(a)

Free Pos. There is no cobas c pack in this position.

Expired The reagent has exceeded its expiration date.

(a) Standby reagents are reagent cassettes already on board but not in use at present. Opposite of active
reagents.

2. Middle subring: Cal (Calibration)

Valid A valid calibration is available.

Requested The reagent is requested for calibration.

Failed Calibration of the reagent has failed.

3. Outer subring: QC (Quality Control)

Valid A valid Control result is available.

Requested Requested for QC measurement.

Violated QC result is not within the confidence limits.

N.A. Not applicable (no QC values available)(a)

(a) In case QC samples have never been measured, the outer subring is shown as N.A.

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Reagent Overview button

Inventory area The Inventory area displays the amount of auxiliary reagents on the analyzer
previously selected on the System Overview screen.

A Bar-chart for the remaining volume

B Color-coded bar

Figure B-61 Inventory area of Reagent Overview window

ISE area

A
C
B
D

A Bar-chart for the remaining volume C Color-coded bar for the remaining volume of
B Color-coded bar for the calibration status ISE reagents
D Color-coded bar for the QC status

Figure B-62 ISE area of Reagent Overview window

The ISE area displays the amount of reagents by way of bar-charts. The first bar below
each bar-chart indicates the remaining volume of each ISE reagent. The second and
the third bar below the bar-charts provide additional, color-coded information on the
statuses of calibration and QC.
1. Remaining volume of ISE reagent:

Abbreviation Unit Description

IS mL Internal standard solution (ISE IS)
DIL mL Diluent
REF mL Reference solution (ISE Ref. solution)
Table B-20 ISE reagent types

2. Second colored bar: Calibration

Valid A valid calibration is available.

Requested The reagent is requested for calibration.

Failed Calibration of the reagent has failed.

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Reagent Overview button

3. Third colored bar: QC

Valid A valid QC result is available.

Requested Requested for QC measurement.

Violated QC result is not within the confidence limits.

N.A. Not applicable (no QC values available)(a)

(a) In case QC samples have never been measured, this is shown as N.A.

Detail Choose the Detail button to display the Detail window. This window displays more
detailed information about the selected cassette, namely: Reagent Type, Test Name,
Remaining Tests, Calibration Date, Calibration Type, Reagent Lot No., Reagent
Sequence Number, First Registration Date, and Expiration Date.

Figure B-63 Detail window

Date format
All dates are displayed according to the selected Set Date/Time setting on the Utility >
System screen.
Month and Year of expiration are indicated by 2 digits each. The format can be mm/yy or
yy/mm depending on the Set Date/Time setting on the Utility > System screen.
Example: For the settings dd/mm/yy and mm/dd/yy, the Expiration Date format is mm/yy.

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Table of contents

Calibration

This chapter provides descriptions of special tasks that are not usually part of the
daily workflow. It is meant to complement the chapter Daily operation, where
everyday tasks and common procedures for running the cobas c 311 analyzer are
described.

In this chapter Chapter 9

Calibration concept ................................................................................................ B-117
Triggers for automatic calibration requests .................................................... B-118
Calibration concept .......................................................................................... B-119
Calibration rules for the photometric unit ............................................... B-120
ISE calibration concept .............................................................................. B-120
Lot and cassette calibrations for the photometric unit ............................ B-121
Calibration masking ......................................................................................... B-121
Calibration Screen Overview ................................................................................. B-122
Calibration Status screen ....................................................................................... B-122
Requesting and cancelling calibrations manually ........................................... B-123
Selecting tests for start-up calibrations ........................................................... B-124
Reviewing calibration data ............................................................................... B-125
Checking calibrations of photometric tests .............................................. B-125
Checking calibrations of ISE tests .............................................................. B-128
Calibration Factors ........................................................................................... B-130
Calibration Install screen ....................................................................................... B-131
Loading calibrator data .................................................................................... B-131
Checking information about already installed calibrators ............................. B-134
Editing concentration values ........................................................................... B-134
ISE calibration .................................................................................................. B-136
Calibration Calibrator screen ................................................................................ B-137
Assigning calibrator positions ......................................................................... B-138
System Overview screen ......................................................................................... B-139
Calibrating tests during operation .................................................................. B-139

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Table of contents

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cobas c 311 analyzer 9 Calibration
Calibration concept

Calibration concept

Calibration The following section gives an overview of the calibration concept applied by the
cobas c 311 analyzer; it provides you with a basic understanding of the various
calibration functionalities implemented on the analyzer and its software.
e For instructions on how to perform calibrations, see Calibration And QC Select button on
page B-48.

What is calibration? Calibration is the process that establishes a relation between measurement values
(such as absorbance values) and corresponding results (concentration of an analyte).
This process may comprise the complete setting up of a new calibration curve or it is
only the update of one or two parameters of an existing calibration curve.—In either
case the term calibration is appropriate.

Automatic calibration The relation between measurement values and results is subject to various
environment and reagent conditions and may drift in the course of time. Therefore it
is necessary to repeat calibrations regularly. To keep the resulting calibration
management simple and efficient the analyzer automatically recommends
calibrations.
To get an overview of the functions provided by the cobas c 311 analyzer for
automating calibration refer to the following section.
e See Triggers for automatic calibration requests on page B-118.

Manually requesting calibration The operator can manually order a calibration. It is possible to request a single test for
calibration or a group of calibration tests.
If a predefined set of calibration tests are to be carried out at the start of analysis run,
it is advisable to define a start-up setting calibration. The tests for Start up calibration
are defined under Calibration > Status > Start Up Setting.
e See To select tests for start-up group calibration on page B-124.

The following calibration settings are defined under the Utility > Application > Calib.
screen.
e See Description of application parameters - Calib. tab on page B-182.

Validation of calibration After a calibration is performed, it needs to be validated. The analyzer performs this
task by means of automatic calibration checks. Whenever it detects an irregular
condition or result, the calibration is classified as failed, a calibration alarm is issued,
and the calibration is automatically recommended to be repeated.

Calibration masking If a calibration fails one or more quality criteria applied in the validation process, tests
are no longer performed with the affected reagent. This is achieved automatically by
means of the auto masking function.
e For more information, see Calibration masking on page B-121.

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Calibration concept

Triggers for automatic calibration requests

The following conditions will automatically trigger a calibration request from the
analyzer:
o Automatic calibration at change of reagents (Changeover calibration):
O Calibration at lot change
O Calibration at cassette change
o Automatic calibration without reagent change:
O Calibration in regular intervals (Timeout)
O Calibration in combination with Preventive action (Calib Now)
O Calibration due to failed QC (QC-triggered calibration (QC Violation))
o Automatic recommendation for recalibration if a calibration failed (Failed)
The different calibration functions can be combined. Only for automatic calibration
without reagent change you have to decide for one workflow: Timeout calibration or
QC violation.
If two or more calibration requests are posed simultaneously for one reagent, only
one of them is indicated according to the following priority:
Failed > Changeover > Timeout / QC Violation > Calib Now > Manual.

Failed If a calibration fails one or more quality criteria, this calibration gets the status Failed.
Failed calibration data are not available for the corresponding cobas c pack.

Changeover calibration Calibrations have to be performed if certain physical events occur. These include:
o A change in reagent lot (of cobas c packs)
o A change of a cobas c pack (regardless of the lot; if requested by application)

Timeout Calibrations are performed at regular intervals to compensate changes over time in
reagents and in the measurement systems. Timeout calibrations can be performed for
lot timeout and for cassette timeout.

QC-triggered calibration Calibration will be initiated if the QC results are outside the confidence limit. Three
(QC Violation) different controls can be defined.
For each application you have to decide whether calibration should be performed
time-triggered (Timeout) or QC-triggered (QC violation).

We recommend to decide for one calibration workflow—time-triggered or QC-triggered—

for all applications. Only few specific applications require a time-triggered calibration.

If a new application is loaded, time-triggered calibration is preselected and the

intervals recommended by Roche are predefined. If you prefer a workflow with QC-
triggered calibration you have to activate QC violation.

Calib Now This automatic calibration function is active only if Preventive Action is activated in
the System Overview screen. If a calibration runs out of time during the period
specified in the Remaining Time box on the Calibration > Status screen, the analyzer
recommends a calibration indicating Calib Now as a calibration trigger.
e For information on the necessary QC violation settings, see Auto Calibration on
page B-183.

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Calibration concept

Calibration concept

Types of calibration curves There are six different types of calibration curves possible on a cobas c 311 analyzer.
That is, there are six different types of mathematical functions possible to describe the
relation between measurement value and result. In this document and in the user
interface (UI), these types of calibration curves are called calibration types. The
names of the calibration types are:

Linear RCM2T1 Spline

RCM (Reaction Calculation Mode) RCM2T2 Line Graph
Table B-21 Calibration types for photometric tests

Each calibration type corresponds to one type of mathematical function. For

example, Linear corresponds to a linear equation, RCM1 to an exponential function.
e For more details, refer to the COBI CD.

Calibration curve parameters A specific calibration curve is defined by its calibration type (mathematical function)
and its parameters. The names of these parameters in the user interface are:
o S1Abs., K, A, B, C, (L, H, I only for serum indices)
A Linear calibration curve, for example, is defined by two parameters (S1Abs. and K),
an RCM calibration curve is defined by four, and a Spline can require up to six
parameters. When the analyzer performs a calibration, it redetermines these
parameters to fit the calibration curve to new measurement values.

For the Spline calibration curve the calculation are neither printed out nor displayed on the
Calibration Result screen. Only S1Abs. is displayed.

Calibration methods Calibrations are performed with varying numbers of calibrators. Up to six calibrators
are used for a full calibration of certain photometric tests. However, not all calibrators
available for a test need to be used in every calibration. To define which calibrators are
used there is a choice of up to four different calibration methods.
The availability of calibration methods depends on the kind of test that has to be
calibrated. The following table displays all calibration methods and the corresponding
calibrators.

Photometric tests ISE tests

Blank Std (1)(a) is used Only ISE Comp. [Std (3)] is used
(not recommended in US)
Span Only one calibrator out of Not available
Std (2)-Std (6)(b) is used
2 Point Std (1) and a second calibrator are ISE Low [Std (1)] and ISE High
used [Std (2)] are used
Full All calibrators [Std (1)-Std (6)] are ISE Low [Std(1)], ISE High [Std(2)],
used (for nonlinear calibration types) and ISE Comp. [Std (3)] are used
(global use)
ISE Low [Std(1)], ISE High [Std(2)],
and ISE High (compensated)[Std (3)]
are used (in US only)
(a) Std (1) is the first standard solution, that is, the calibrator with the lowest analyte concentration. For
photometric applications water is used as a blank calibrator.
(b) Std (2)-Std (6) refers to calibrators assigned to an application under Utility > Application > Others.

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Calibration concept

Calibration rules for the photometric unit

o Calibration is best done as a part of the daily preroutine operation. However, it
can be done at any time during operation as well.
o Multi-calibrators are usually used. Calibrator data is downloaded via cobas link.
o Calibrations are carried out in duplicate.
o Hitachi micro cups are not applicable to calibrators and QCs.
o Barcoded calibrators:
Roche calibrators are always supplied with barcode labels (inserted in the
calibrator kit). A barcode for water is also available but must be ordered
separately.
The labels must be placed on a tube.
o Non-barcoded calibrators can be used as well. In this case calibrators have to be
assigned to specific positions (position assignment).
o Calibrators can be used several times for calibrations.

ISE calibration concept

ISE calibrators can be used with or without barcodes. The labels for the ISE Standards 1
and 2 (ISE Low and ISE High) can be found on the back of the boxes. The label for the
ISE Comp. can be found inside the box.
o Calibrations are carried out in triplicate.

Full calibration Full calibration for Na+, K+, and Cl- requires the following 3 calibrator solutions:
o ISE Standard 1 (ISE Low)
o ISE Standard 2 (ISE High)
o ISE Standard 3 (ISE Comp.)
o ISE Standard 3 (ISE High) for US only
The slope of the calibration curve is calculated from ISE Standards 1 and 2. ISE Low
and ISE High are aqueous standards. ISE Comp. / ISE High (compensated) is designed
to reduce matrix effects. A full calibration is required every 24 hours.

One-point calibration The ISE internal standard (ISE IS) is measured before and after each routine sample
(only one measurement for sample analyses in succession). These measurements are
used to correct for system-related drifts (junction potential differences, differences in
electrode conditions, etc.).
The ISE IS is also measured during calibration as well.

Two ISE calibration curves It is possible to set up and use two independent sets of calibration curves for Na+, K+,
and Cl-. Choose an ISE test from the test list under Utility > Application and then the
Other tab to display calibrator codes, concentration values, and sample position
numbers. The Other tab contains two areas, Type A and Type B, where each area
relates to one of the two independent calibration curves.
If only one sample type is calibrated, only one calibration has to be performed for
sample Type A and B.
e For information on installation and assignment of calibrations, see ISE calibration on
page B-136.

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Calibration concept

Lot and cassette calibrations for the photometric unit

Lot calibration Lot calibration data are reagent lot specific for the test. Lot calibration data are
transferred to other cobas c packs belonging to the same reagent lot. The lot
calibration data are applied to result calculations of all patient samples and controls.
A lot calibration can only be generated from a fresh cobas c pack, which means that
the calibration must be performed within 24 hours after the cassette has been loaded
on the analyzer.

Cassette calibration Cassette calibration data are cassette-specific. A cassette calibration is generated if a
cobas c pack is calibrated which is loaded on the analyzer more than 24 hours ago and
all calibration quality criteria are met.
Most of the photometric tests need to be calibrated only if the reagent lot is changed
(lot calibration). Some of the tests, however, need to be calibrated whenever a new
cobas c pack is inserted (cassette calibration).

Calibration masking

Automatic calibration masking is a function which masks a cobas c pack. This

function is activated (or deactivated) for the entire analyzer under Utility >
System (Page 2/5) > Calib Mask Setting. If activated, the function can be selected
individually for each application on the Utility > Application > Calib. screen.

Failed calibrations If a calibration is successful, the calibration data are available for the measurement of
patient samples and controls. If a calibration fails one or more quality criteria, this
calibration gets the status Failed. Failed calibration data are not available for the
corresponding cobas c pack.
If automatic calibration masking is activated, the corresponding test with the Failed
calibration data is masked. If automatic calibration masking is not activated, the test
is not masked but data alarms are attached to the results.
The Failed calibration can be rejected by the operator (Reject button on Calibration >
Status). In this case, the last successful calibration will be used. However, the original
calibration recommendation still remains for the cobas c pack.

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Calibration Screen Overview

Calibration Screen Overview

Calibration The calibration menu contains three screens: Calibration > Status, Calibration >
Calibrator, and Calibration > Install. This chapter describes important commands
accessed via these screens as well as various information displayed on them. However,
this chapter does not cover all possible commands. For a complete description of all
fields of the software’s user interface, refer to the Online Help.
e For more information about the calibration menu, refer to the Online Help.

Calibration Status screen

The following sections explain certain tasks associated with the Calibration > Status
screen. Not all tasks are described but the most important ones.
e For a complete description of all elements of the user interface, refer to the Online Help.

To display this screen choose Calibration > Status.

Figure B-64 Calibration > Status screen

e For information about particular tasks associated with this screen, see:
Requesting and cancelling calibrations manually on page B-123
Reviewing calibration data on page B-125
Selecting tests for start-up calibrations on page B-124
Calibration Factors on page B-130.
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

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Calibration Status screen

Requesting and cancelling calibrations manually

According to the intended use, calibrations will be automatically requested from the
analyzer and from the operator via the System Overview screen. Regardless of these
requests from the analyzer calibrations can be manually selected and deselected as
well.

a To request a calibration for a test manually

1 Choose Calibration > Status.
2 Select the test and the cobas c pack that needs to be calibrated from the list.
The selected line is highlighted in blue.
3 Select the appropriate button in the Method area for a Blank, 2 Point, Full, or
Span calibration.
The selected option appears in the Calib. Method column highlighted in green,
the Cause column indicates Manual, and the Save button turns yellow.
4 To request calibrations for additional reagents and tests repeat steps 2 and 3.
5 Choose Save.
All listed tests and reagents that have an entry in the Calib. Method column
highlighted in green correspond to a requested calibration.

a To cancel a calibration request manually

1 Choose Calibration > Status.
2 Select the reagent and test whose calibration request is to be cancelled.
The selected line is highlighted in blue, the entry in the Calib. Method column is
highlighted in green, and the corresponding button in the Method area is
highlighted in white.
3 Select the highlighted button in the Method area.
The entries in the Calib. Method and Cause column for this reagent disappear and
the Save button turns yellow.
4 To cancel further calibration requests repeat steps 2 and 3.
5 Choose Save to save the changes.

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Calibration Status screen

Selecting tests for start-up calibrations

The start-up calibration function allows you to select a number of tests and treat
them as a group. Tests selected for start-up calibration will be requested for
calibration when the Start Up button is chosen either from the Calibration and QC
Select window, or directly from Calibration > Status.
The set of tests that are selected in a start-up calibration group, including the
respective calibration methods, is defined under the Calibration > Status > Start Up
Setting window.

a To select tests for start-up group calibration

1 Choose Calibration > Status > Start Up Setting.

Figure B-65 Start Up Setting window

2 Choose Start Up Group Setting.

3 Select a Start Up group.
4 Enter a group name and choose OK.

o Up to seven groups can be set in the Start Up Group Setting window.

o Up to 16 characters can be entered for a group name.

5 Select the Start Up Group from the drop-down list.

6 Select one or more tests from the list and specify your calibration method.

The selected test is highlighted in blue and the calibration method is highlighted in green.
For ISE assay, specify Full.

7 Choose Update.
8 Repeat steps 4-7 for each group.
9 After completing settings for all of the groups, choose OK.
10 Select Start Up Group from the drop-down box and choose Start up on the
Calibration > Status screen to activate the selected calibrations or from the
Calibration and QC Select button on the System Overview screen.
11 Choose Save to confirm the start-up calibrations.

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Calibration Status screen

Reviewing calibration data

After a calibration is completed it must be reviewed. Details for each calibration

performed on any of the analyzer’s units can be retrieved from the Calibration >
Status screen. The following sections describe the possibilities to check calibration
data according to the different kinds of test calibrated.
e For further information, see:
Checking calibrations of photometric tests on page B-125
Checking calibrations of ISE tests on page B-128.

Checking calibrations of photometric tests

For each successful calibration of a photometric test, the following information is
available:
o Calibration factor: Parameters that determine shape of the calibration curve.
e See Calibration Factors on page B-130.
o Calibration curve: Mathematical relation between the measured signal (for
example, absorbance or rate of change in absorbance) and the corresponding
concentration value for the concerned analyte.
o Reaction monitor: A graph showing the measured absorbance in the course of a
test measurement.
o Calibration trace: A graph used to review the measurements of the 50 most recent
calibrations for a specific test. It shows signal values for both the Std (1) calibrator
and the calibrator with the maximum concentration on one plot.

a To review calibration data

1 Choose Calibration > Status.
2 Select a photometric test from the list on Calibration > Status.
3 Choose Calibration Result to display the Calibration Result window.

S1Abs., K, A, B, and C = Calibration curve parameters (S1Abs. and K for linear calibration
curves)

Figure B-66 Calibration Result (Photometry) window

This window gives information about the most recent calibrations for the
displayed photometric tests.

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Calibration Status screen

o To display the calibration curve of a selected test choose Working Information.

o To display the calibration factors for the cassette calibration, lot calibration,
and newest calibration of a selected test choose Calibration Factor.
e For more details about calibration factors, see
Calibration curve parameters on page B-119
Calibration Factors on page B-130.

a To review measurement details of the most recent calibration

1 Choose Calibration > Status.
2 Select a photometric test from the list on Calibration > Status.
3 Choose Reaction Monitor to display the Reaction Monitor window.
This window displays reaction graphs for each of the duplicate measurements of
each calibrator used for the calibration selected.

Figure B-67 Reaction Monitor window of a 2 Point End assay

4 Use the drop-down list above the graph to select a specific measurement. The
extensions 1st and 2nd in the list correspond to the first and second measurement
of each calibrator, respectively.
e For a complete description of all fields and buttons, refer to the Online Help.
e For background information about photometric principles, refer to the COBI CD.

The measuring points of the reaction monitor of a calibration can be printed out: First,
select a test from the Calibration > Status screen, then, choose Print (global button), select
Reaction Monitor from the list on the left, and choose Print.

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Calibration Status screen

a To review results of previous calibrations

1 Choose Calibration > Status.
2 Select a photometric test from the list on Calibration > Status.
3 In order to review the results of previous calibrations of the selected test, choose
Calibration Trace.

Figure B-68 Calibration Trace window

This window displays a graph showing calibration results for both the Std (1)
calibrator and the calibrator with the maximum concentration on one plot.
The left and right y-axes are scaled independently:
The left axis refers to the Std (1) calibrator represented by .
The right axis refers to the maximum calibrator represented by .
e For a complete description of all fields and buttons, refer to the Online Help.

The calibration trace list can be printed out. First, select a test from the Calibration >
Status screen, then, choose Print (global button), select Calibration Trace from the list on
the left, enter date range, and choose Print.

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Calibration Status screen

Checking calibrations of ISE tests

For each successful calibration of an ISE test, the following information is available:
o Calibration Result button — Working Information (ISE): Results from the most
recent successful ISE calibration for the test selected.
o Calibration trace: A graph used to review the measurements of the 50 most recent
calibrations for a specific test. It shows both the measured data for the selected
test’s compensator ISE Comp. (in mmol/L) and slope values (in mV) on one plot.
For US only, ISE High (compensated) is used instead of ISE Comp.

a To review calibration data

1 Choose Calibration > Status.
2 Select an ISE test from the list on Calibration > Status.

The entries ISE-A and ISE-B refer to two different calibration curves that can be assigned
to different sample types. For example, ISE-A is assigned to serum/plasma and ISE-B to
urine samples. This assignment is set on Utility > System (Page 3/5) > ISE Calib Setting.

3 Choose Calibration Result to display the Working Information (ISE) window.

Figure B-69 Working Information (ISE) window

This window displays information about the most recent successful ISE
calibration: Electromotive force (EMF), slope, and target concentration values.
The three Compensated Value text boxes display the difference between the target
value of the ISE compensator [ISE Std (3)] and its measured values for Na+, K+,
and Cl–. This difference is added to all measured routine samples and controls.
This is done to compensate for the fact that the internal standard (ISE IS) and the
calibrators Std (1) and Std (2) are aqueous solutions whereas the patient samples
being measured are serum-based solutions.
The slope of the calibration curve is calculated from ISE Standards 1 and 2.
ISE Comp. is designed to reduce matrix effects. It only affects the intercept and
not the slope.
For US only, ISE High (compensated) is used instead of ISE Comp.

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Calibration Status screen

a To review results of previous ISE calibrations

1 Choose Calibration > Status.
2 Select an ISE test from the list on Calibration > Status.
3 Choose Calibration Trace to open the Calibration Trace window.
4 Select a test from the drop-down list on the top left of the window.
The graph shows calibration results for the selected ISE test. The left and right y-
axes are scaled independently: The left axis refers to the measured concentration
values of the ISE compensator [ISE Std (3)]represented by . The right axis refers
to the calculated slope values represented by .
e For a complete description of all fields and buttons, refer to the Online Help.

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Calibration Status screen

Calibration Factors

The term calibration factors refers to coefficients (S1Abs, K, A, B, C) used for setting
up calibration curves for photometric tests. The analyzer stores calibration factors for
each calibration curve of all registered cobas c packs.
The following kinds of calibration factors are available: Cassette, Lot, and Newest.

Lot calibration factors Lot calibration factors are reagent lot specific for the test. Lot calibration factors are
transferred to other cassettes belonging to the same reagent lot. The lot calibration
data are applied to result calculations of all patient samples and controls.
A lot calibration can only be generated from a fresh cobas c pack, which means that
the calibration must be performed within 24 hours after the cassette has been loaded
on the analyzer.

Cassette calibration factors Cassette calibration factors are cassette-specific. A cassette calibration is generated
when a cobas c pack is calibrated which is older than 24 hours after being loaded on
the analyzer for the first time and all calibration quality criteria are met.
Most of the photometric tests need to be calibrated only when the reagent lot is
changed (lot calibration). Some tests, however, need to be calibrated whenever a new
cobas c pack is inserted (cassette calibration).

Newest calibration factors Newest calibration is a function that allows you to replace empty cobas c packs
without performing a calibration (if no changeover calibration is recommended for
this application).
For a reagent cassette for which no applicable calibration data exists, the newest
calibration is transferred at the time of reagent registration. The newest calibration is
always the last generated lot calibration of this test. This is used to prevent that a
cobas c pack of a new lot loaded on the analyzer does not have any calibration data.
Always the newest calibration data are transferred.

a To check calibration factors

1 Choose Calibration > Status.
2 Select a photometric test from the test list.
3 Choose Calibration Result.
4 On the Calibration Result window, choose Calibration Factor.
The Calibration Factor window opens.

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Calibration Install screen

Calibration Install screen

The following sections contain certain tasks associated with the Calibration > Install
screen. Not all tasks are described but the most important ones.
To display this screen choose Calibration > Install.

Figure B-70 Calibration > Install

The Calibration > Install screen is used to review information about already
registered calibrators, to update calibrator data, and to install new calibrators.
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

Loading calibrator data

Information regarding calibrator codes, lot numbers, expiration dates, and

concentration values can be downloaded to the analyzer from cobas link. An operator
ID of supervisor level or higher is required for this operation.
This operation is a part of the installation process for a new application.
e For an overview of the complete installation process of a new application, see:
Loading or updating applications on page B-174.

In case calibrators are used without barcodes, assign the calibrator positions manually.

a To download calibrator data from cobas link

1 Make sure that the analyzer is in standby.
2 Choose Calibration > Install > Download to open the Download window.

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Calibration Install screen

Figure B-71 Download window for calibrator data

3 Select one of the available search options (Required Item, Calibrator Name, Lot
Number, or Release Date).
o The option Required Item refers to calibrator data that have not been found on
the analyzer at the time of placing calibrators on the analyzer.
o The option Release Date refers to the date when the calibrator was released by
Roche.
4 Choose Search to start searching for the selected criteria. The search results are
displayed.

Figure B-72 Download window with search results

In the column Note you can find additional information about the calibrator such
as reason for change.
To change the order of the list select the Sort By option.
5 Select the Selection check box of each list item to be downloaded.
6 Choose Download and confirm with OK.

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Calibration Install screen

Figure B-73 Confirmation window

7 Choose OK to start the download process.

8 Choose Close to return to the Calibration > Install screen and verify the
downloaded information has been registered correctly.
9 Choose OK to save the data.
Using calibrators without barcodes requires the assignment of the calibrator to a
specific position.
e See To assign a calibrator to a specific position on page B-138.

a To add calibrators manually (without cobas link)

1 Select a blank line from the control list on the Calibration > Install screen.
2 Choose Add.
3 Type all necessary data in the Add Calibrator window.
The Code range is from 1-998. Ensure that the calibrator code is not already used.

Figure B-74 Add Calibrator window

4 Choose OK. The new calibrator appears on the calibrator list.

Using calibrators without barcodes requires the assignment of the calibrator to a
specific position.
5 Enter the concentration values of the calibrator.
e See: To enter or edit concentration values of a calibrator on page B-134
e See: To assign a calibrator to a specific position on page B-138.

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Calibration Install screen

Checking information about already installed calibrators

This section describes how to check registered calibrator data.

In case calibrators are used without barcodes, assign the calibrator positions manually.

a To check registered calibrator data

1 Choose Calibration > Install.
2 Select a calibrator from the list on the left.
The list on the right displays the registered concentration values for this calibrator.
3 In order to look up a calibrator’s calibrator code, position, lot number, or
expiration date choose Calibration > Calibrator.

Editing concentration values

The concentration value of a calibrator can be edited on the Calibration > Install
screen. You can use this function to define the number of decimal places for Std (1)
used for reportable data.

a To enter or edit concentration values of a calibrator

1 Choose Calibration > Install.
2 Select the calibrator to be edited from the list on the left.
3 Choose Edit. The Edit Calibrator window opens.

Figure B-75 Edit Calibrator window

4 Select a test (analyte) from the list whose calibrator concentration value is to be
entered or edited.
5 Select a box in the Std Concentration area and type the appropriate concentration
value. Observe the respective unit of measure displayed below the Std
Concentration area.
Std (1) is used for the blank calibrator. Std (2) through Std (6) are used for all
other calibrators.

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Calibration Install screen

The number of decimal places used for Std (1) defines the number of decimal places used
for reportable data.

6 After the value is entered, complete the input by choosing Update.

7 If you need to edit additional tests, repeat steps 4 through 6.
8 Choose OK to save all changes and close the window.

Incorrect results due to wrong calibration

After changing the calibrator concentration for any calibrator [Std (1)-Std (6)] or the
CAUTION number of decimal places for Std (1), always recalibrate the test with a full calibration in
order to ensure no incorrect results are reported.

9 Calibrate the test.

10 Perform QC measurements.

No update of manually edited concentration values

In case a value has been manually edited, this value will not be updated when you
download new calibrator values from cobas link.
If you want to return to the original concentration value, delete the calibrator and
download it again from cobas link. Perform calibration before you resume routine
operation.

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Calibration Install screen

ISE calibration

ISE calibrators low and high can be used with or without barcode labels. Without a
barcode you have to register the calibrators, assign a calibrator position to them, and
enter the relevant concentration values for each calibrator as described above.
When the analyzer configuration is completed, the three calibrators —ISE Low,
ISE High, and ISE Comp.—used in an ISE calibration must always be placed in their
assigned positions.
For US only, ISE High (compensated) is used instead of ISE Comp.
e For details see:
Requesting and cancelling calibrations manually on page B-123
Editing concentration values on page B-134
Assigning calibrator positions on page B-138.

Two ISE calibration curves For ISE tests it is possible to apply one of two independent calibration curves. After
installation and assignment, the respective calibrator values are displayed under
Type A and Type B on Utility > Application > Other.
The assignment of one or the other calibration curve to a certain sample type is set on
Utility > System (Page 3/5) > ISE Calib Setting.

Figure B-76 Utility > System (Page 3/5) > ISE Calib Setting window

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Calibration Calibrator screen

Calibration Calibrator screen

The following sections contain certain tasks associated with the Calibration >
Calibrator screen. Not all tasks are described, but the most important ones.
To display this screen choose Calibration > Calibrator.

Figure B-77 Calibration > Calibrator window

The Calibration > Calibrator screen is used to review information about already
registered calibrators and to assign calibrators to specific positions manually. The
position assignment is necessary for calibrators that are used without barcode
identification.
e For information about particular tasks associated with this screen, see:
Assigning calibrator positions on page B-138.
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

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9 Calibration cobas c 311 analyzer
Calibration Calibrator screen

Assigning calibrator positions

Use the following procedure to assign a calibrator to a position if you are using cups
without a barcode, or if the analyzer cannot read the barcode on the calibrator.

It is possible to do a calibration with barcoded and non-barcoded calibrators mixed.

However, you have to assign the position of the non-barcoded calibrator and no position
should be assigned for the barcoded calibrator. If you put a barcoded container on a
position which was assigned manually, the calibration is not measured.

a To assign a calibrator to a specific position

1 Choose Calibration > Calibrator > Position Assignment.

Figure B-78 Calibrator Position Assignment window

2 Select the calibrator to be assigned to a position from the list on the left.
3 Select a position from the list on the right. The position selected for the
assignment has to be an empty line in the list.
4 Choose Assign to assign the selected calibrator to the selected position.
To undo the assignment choose Remove or choose Cancel to leave the Calibrator
Position Assignment window without saving any changes.
5 To assign further calibrators repeat steps 2 to 4.
6 After all necessary assignments are completed, choose OK to save the changes.

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System Overview screen

System Overview screen

The following section explains calibration tasks associated with the System Overview
screen.
Choose the graphical icon representing the configuration in the status line (top left of
the screen), or press F12 to display the System Overview screen.

Calibrating tests during operation

Calibration is usually performed at the beginning of routine operation before sample

processing begins. However, it can be done any time during routine operation as well.
The procedure for calibrating tests during operation is essentially the same as the
calibration at the beginning of routine operation:

a To perform calibrations during operation

1 Request the recommended calibrations via the Calibration and QC Selection
button (highlighted yellow) on the System Overview screen.
2 Select an option from the Load List area to select the respective lists for printing.
3 Print the selected load lists.
4 Choose Pause/Scan (global button), then Pause. Wait for the green Access Sample
Disk lamp to turn on.
5 Load calibrators onto the sample disk as described on the Calibration load list.
6 Choose Start (global button). Choose Start on the Start Conditions screen. The
Start screen closes and the calibration and control run begins.
e For a detailed description of the calibration process at the beginning of routine operation,
see:
Calibration And QC Select button on page B-48
Requesting calibration and QC and printing load lists on page B-48
Measuring calibrators and controls on page B-52.

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System Overview screen

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cobas c 311 analyzer 10 QC
Table of contents

QC

This chapter explains certain tasks associated with the QC menu. Not all tasks are
described but the most important ones.

In this chapter Chapter 10

QC concept ............................................................................................................. B-143
QC methods ...................................................................................................... B-143
System implementations for QC measurements ............................................ B-143
Definitions concerning QC .............................................................................. B-144
Accumulation of QC measurement data ........................................................ B-145
Working in barcode or non-barcode mode .................................................... B-145
QC Status screen .................................................................................................... B-146
Timeout QC ...................................................................................................... B-147
Requesting QC measurements ......................................................................... B-148
QC Run Status screen ............................................................................................. B-150
QC Individual screen ............................................................................................. B-152
Excluding an individual QC point or adding a comment .............................. B-153
Configuring and using realtime QC ................................................................ B-154
Configuring realtime QC ................................................................................. B-157
Accumulation of QC results ............................................................................ B-159
System settings for QC accumulation ....................................................... B-159
Accumulating QC results ........................................................................... B-159
QC Cumulative screen ........................................................................................... B-160
QC Control screen ................................................................................................. B-162
QC Install screen .................................................................................................... B-164
Loading control data ........................................................................................ B-165
Editing control values ...................................................................................... B-168
Activating control tests ..................................................................................... B-169
Programming auto QC measurements ................................................................. B-170

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Table of contents

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QC concept

QC concept

Regularly perform QC measurements to continually monitor the instrument

performance. After measurement of QC samples, data can either be transferred to
and processed on a Host or they can be processed on the analyzer.

QC methods

The following QC methods are available on a cobas c 311 analyzer: Individual (intra-
day) QC, cumulative (long-term) QC, and realtime QC.

Individual and cumulative QC All results of QC measurements can be viewed on the QC > Run Status screen and the
QC > Individual screen. It is recommended to transfer QC data at the end of a day
from the individual QC to the cumulative QC. Under cumulative QC you find all the
long-term quality control data stored on the analyzer.
e For more information see:
QC Run Status screen on page B-150
QC Individual screen on page B-152
QC Cumulative screen on page B-160
e For more details on the accumulation of QC data (from individual to cumulative QC), see:
Accumulation of QC measurement data on page B-145
Accumulation of QC results on page B-159.

Realtime QC Independent of individual and cumulative QC, the realtime QC function allows the
evaluation of QC measurement immediately after their results become available
(realtime) utilizing the Westgard algorithm.
Realtime QC for one test always uses two kinds of controls and compares QC results
against the controls’ known standard deviation (SD) and mean values.
e For more information on realtime QC, see Configuring and using realtime QC on
page B-154.

System implementations for QC measurements

In addition to the QC methods explained above, there are six types of

implementations which are available to manage the measurement of QC samples:
o Routine QC
o Standby reagent QC
o Timeout QC
o Automatic QC
o QC after calibration
o Manual QC

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QC concept

Routine QC Each test has one or more controls assigned to it. Moreover, a test must be not only
assigned to a control but also activated for that control to make a QC measurement
possible. Routine QC comprises all activated tests of all installed controls. You can
request a QC measurement for all of these tests—for example at, the beginning of a
work shift—with one single command (System Overview > Calibration and QC
Select > Routine QC).
e For more information about routine QC, see:
Requesting QC measurements on page B-148
To perform controls for active reagents on page B-148

Standby reagent QC QC measurements can be requested individually for standby cobas c packs. Standby
cobas c packs are already on board but not in use at present.
e For more information about standby reagent QC, see:
Requesting QC measurements on page B-148
To perform controls for standby cobas c packs on page B-148

Timeout QC QC measurements can be performed at predefined (test-specific) time intervals.

When the time interval has elapsed, the analyzer issues a recommendation for a QC
measurement. This is indicated by the Calibration and QC Select button on the
System Overview screen highlighted in yellow.
In case an automatic QC sample is on the sample disk, this QC is performed
automatically.
e See Timeout QC on page B-147.

Automatic QC It is possible to keep frequently used controls on the sample disk—ready to be used
any time before or during routine operation. Thus, in combination with Timeout
QC, the analyzer is able to perform QC measurements without any intervention by
the operator.
e See Programming auto QC measurements on page B-170.

QC after calibration For this kind of QC measurements no special settings are needed. QC measurements
are performed for all calibrated tests without explicit requests from the operator,
when the control is activated and on board.
e See To perform QC after calibration on page B-149.

Manual QC This function allows you to measure QCs of any test based on your judgment.
e See Requesting QC measurements on page B-148.

Definitions concerning QC

This section explains some QC expressions that are used in the following:
o Active cobas c packs are currently in use. Sometimes called current reagents. The
opposite are standby cobas c packs.
o Controls or control samples are used synonymously for quality controls (QCs).
Controls are special samples that are used for QC.

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QC concept

Accumulation of QC measurement data

At the end of daily operation, QC measurement data should be accumulated. When

accumulating QC results, the corresponding data are deleted from the QC >
Individual screen and transferred to the QC > Cumulative screen.

Two accumulation methods There are two accumulation methods available: Mean-R and X-R. The choice for one
or the other method is made under Utility > System (Page 1/5) > QC Setting.
o X-R transfers only one QC result from individual QC to cumulative QC.
Therefore you must specify a measurement when accumulating QC data.
o Mean-R calculates cumulative QC data on the basis of all individual QC results
being accumulated.

Two calculation methods If Mean-R is set as accumulation method, two methods are available for the
calculation of mean values and SD values in cumulative QC: DayToDay and Overall.
o The Overall method uses a weighting factor for each accumulated set of data.
o In the DayToDay calculation method all accumulations have the same weight.
The calculation method is selected under Utility > System (Page 1/5) > QC Setting.

Working in barcode or non-barcode mode

On the Utility > System screen under Barcode Setting, you can verify or change
whether the analyzer uses barcodes for controls or not.
When working with barcodes, controls are automatically identified. In case controls
are processed in non-barcode mode, it is necessary to assign a position for each
control.
The current position assignment is listed on the QC > Control screen. To provide
additional assignments or remove existing assignments choose Position Assignment.

o For assigned controls (without barcode), be sure to use the specified position. A
misplacement would go undetected by the analyzer and yield invalid results.
o Do not use barcoded and assigned controls on the same QC position.

e For more information see QC Control screen on page B-162.

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QC Status screen

QC Status screen

The following sections explain certain tasks associated with the QC > Status screen
screen. Not all tasks are described but the most important ones.
To display this screen choose QC > Status.

Figure B-79 QC > Status screen

The QC > Status screen displays all installed controls with the corresponding assigned
and activated tests.
The test display can be sorted by test name (alphabetical order), control name
(alphabetical order), QC test selection, or QC cause. Tests can be selected with the
Select/Deselect button. Selected tests are highlighted in green. A control test selection
is made for the subsequent control run. The control test selections of the status list
disappear after the control is measured.

Only the test selection of pipetted control tests disappear. If a test is requested but the
control sample is not on board, the QC request remains.

Routine QC Assign The Routine QC Assign button selects all Routine QC tests (active reagents only) for a
control measurement. Routine QC tests are all activated tests for all installed controls.
Tests that are not to be measured can be deselected on the Status screen: Highlight the
tests on the status list and then use the Deselect button.

Stability Timer Reset Use this button to reset the On Board Stability Time (set in Utility > Application >
Range). In case the on board stability time of the control is expired (highlighted
yellow in QC > Status plus a yellow alarm message), the timer can be reset with this
button after the control material is exchanged. This function is only available in
Standby or Pause.

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QC Status screen

Direct access from System From the System Overview screen, select the Calibration and QC Select button and
Overview screen then the Routine QC button in the QC area on the right. This is essentially the same
as selecting the Routine QC Assign button on QC > Status.
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

Timeout QC

A control interval in hours can be defined for each application on the Range tab on
Utility > Application. Select the Control Interval Time check box and type the
appropriate time in the adjacent text box.

Figure B-80 Range tab on Utility > Application

The analyzer checks the timeout every 30 minutes. When the specified time has
elapsed, a QC request is triggered. This QC request is indicated on the QC > Status
screen by the word Timeout in the Cause column.
Be sure to place an appropriate QC sample on the sample disk in advance for auto
QC.
The control is measured with the active (in use) cobas c pack.

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QC Status screen

Requesting QC measurements

QC measurements can be requested individually for active and standby cobas c packs.
Active cobas c packs are currently in use. Standby cobas c packs are already on board
but not in use at present.

Expired controls are possible to be used on cobas c 311 analyzer. No alarm is issued.

e For more information about requesting QC manually, see:

To perform controls for active reagents on page B-148
To perform controls for standby cobas c packs on page B-148
To perform QC after calibration on page B-149

a To perform controls for active reagents

1 Choose QC > Status.
2 If routine QC is to be performed, choose Routine QC to select all tests that are
currently loaded on the analyzer and activated for QC.
If individual tests are to be selected, go to step 3.
3 Choose the appropriate test and control. Multiple tests and controls can be
highlighted.
4 Choose Select. A green bar appears in the Selection column. Manual is displayed
in the Cause column. The Select button toggles to Deselect.

Choosing Deselect deselects a highlighted item and Deselect toggles to Select.

5 Choose Save to request the selected controls for measurement.

Now, continue with the procedure: To print a QC load list and to load controls on
page B-149.

a To perform controls for standby cobas c packs

1 On QC > Status choose Stand By Bottle QC to display the Stand By Bottle QC
window.

Figure B-81 Stand By Bottle QC window

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QC Status screen

2 Select the appropriate test and control. Multiple tests and controls can be
highlighted.
3 Choose Select to select all highlighted tests and controls. A green bar appears in
the Selection column. The Select button toggles to Deselect.

Choosing Deselect deselects a highlighted control and the Deselect button toggles to
Select.

4 Choose OK to request the selected controls for measurement.

Now, continue with the next procedure: To print a QC load list and to load controls.

a To print a QC load list and to load controls

1 Choose Print (global button) > QC and select QC Load List.

You can also print a QC load list from System Overview > Calibration and QC Select. Select
the QC Only option in the Load List area.

2 Choose Print. The analyzer prints a QC load list.

Calibration or QC failure
If you have to manually assign a calibrator or QC container or other sample container—for
CAUTION example, due to an unreadable barcode—do not place any containers with barcodes in
manually assigned positions.
It is possible to do a QC with a mixture of barcoded and non-barcoded QCs. However, you
must assign the position of the non-barcoded QC and no position should be assigned for
the barcoded QC. If you put a barcoded container on a position that was assigned
manually, the QC is not measured.

3 Load the controls onto the sample disk.

If you perform QC after calibration, QC samples do not have to follow directly after
calibrator samples. Other samples can be placed in between them.

a To perform QC after calibration

A calibration request automatically triggers a QC request for that cobas c pack (active
and standby cobas c packs). Controls have to be loaded on the sample disk.

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QC Run Status screen

QC Run Status screen

To display this screen choose QC > Run Status.

Figure B-82 QC > Run Status screen

Use the Run Status screen to get an overview of the last 500 quality control (QC)
measurements performed on the analyzer or to view the most recent QC
measurements for one particular test specified.
Use the Test box to select all tests or one specific test to be displayed on the chart. Use
the scroll bar at the bottom of the chart to move the focus from one result to the next.
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

QC run status details The Run Status screen consists of a details area in the upper part of the screen and a
run status chart in the center of the screen. The details area displays information that
relates to the QC measurement selected on the run status chart. The chart in the
center of the Run Status screen displays up to 500 results of QC measurements.

Chart background A white background refers to today’s measurements. A blue background refers to past
days’ measurements.

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QC Run Status screen

Chart symbols Shape: Circles are used if QC violation is activated for a test in Utility > Application >
Calib; otherwise triangles are used.
e For more information on QC violation, see QC-triggered calibration (QC Violation) on
page B-118.

Color: Red denotes that a QC result falls outside the confidence limits, and yellow
denotes that it is outside 2 SD limits. Green symbols are used for results within the
relevant limits.

Displayed if QC violation is QC result exceeds confidence limit (right axis of

activated chart). A calibration is automatically
recommended for the affected test.
Displayed if QC violation is QC result within confidence limits
activated
Displayed if QC violation is not QC result falls outside ± 2 SD (left axis of chart)
activated and confidence limits
are not checked
Displayed if QC violation is not QC result within ± 2 SD
activated

Special fields in the details area Status: This field displays a reagent’s status of precedence. Possible values are Current,
SB1, SB2, SB3…

Current cobas c pack currently in use, same as active cobas c pack

SB1 (Standby cobas c pack 1): The cobas c pack which will be used after the active
cobas c pack.
SB2 (Standby cobas c pack 2): The cobas c pack which will be used after SB1.

The order of precedence of standby cobas c packs within the same lot is assessed by the
time of registration; the oldest standby cobas c pack is used first.

cl-low / cl-high: These fields display the confidence limits specified for the selected
test. If the selected test is not configured for QC violation but for timeout calibration,
the fields under cl-low and cl-high are blank.

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QC Individual screen

QC Individual screen

The following sections explain certain tasks associated with the QC > Individual
screen. Not all tasks are described but the most important ones.
To display this screen choose QC > Individual.

Figure B-83 QC > Individual screen

The QC > Individual screen lists all nonaccumulated QC results.

The list can be sorted by test name and control name. The table below explains the
most important columns of the list.

Control Name of the control

Lot No. Lot number of control material
Target Mean Control target mean
Target SD Control target standard deviation
N Number of QC runs carried out on this control since the last
accumulation
Mean Calculated mean of N measurement results
SD Standard deviation calculated from N control measurements
CV [%] Coefficient of variation calculated from the mean value
Result Most recent QC result of this control

e For information about particular tasks associated with this screen, see:
Excluding an individual QC point or adding a comment on page B-153
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

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QC Individual screen

Individual QC Chart window On the QC > Individual screen, choose Chart to open the Individual QC Chart
window.

Figure B-84 Individual QC Chart window

This window displays all non-accumulated QC results of the selected test in a Levey-
Jennings chart. A Levey-Jennings chart provides a visual method of monitoring
trends in QC results. The result values are scaled to the standard deviation (SD) of the
respective test.
Up to three controls can be selected (Select button) and displayed on one chart.

Excluding an individual QC point or adding a comment

Individual QC points on a QC chart can be excluded from QC calculations if

required. It is also possible to annotate individual QC points.

a To exclude an individual QC point and add a comment

1 Choose QC > Individual > Chart.
2 Select the QC point to be excluded from QC calculations.
3 Choose Comment on the Individual QC Chart window to display the Comment
window.
4 If necessary type a comment (max. 20 characters) in the Comment box.
5 Choose Exclude. The window is closed after confirmation.
This removes the point from statistics but continues to display the information on
the chart.

A comment is attached to this point

The point is excluded

The point is excluded and a comment is attached

Excluded points cannot be included later.

6 Choose OK.

Control values of standby cobas c packs are always excluded.

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QC Individual screen

Configuring and using realtime QC

In realtime QC the analyzer uses the Westgard algorithm to evaluate QC

measurements. The Westgard algorithm is based on a multi-rule Shewhart-type
method and applies a set of rules to each QC. These rules are selected in QC >
Individual > Realtime QC > Select Rules for each test.

Quality control by the Shewhart The instrument measures two controls (X and Y) in pairs, whose mean value ( X ) and
method standard deviation (SD) are known for each test. Each QC result is processed
according to the judgment standard (multi-rule) and it is judged whether it can be
reported or not.—When the algorithm yields an error, an alarm is generated
indicating whether the error is a random error, a QC error, or a systematic error.
The kinds of realtime QC samples are 100 at a maximum. The following figure shows
an illustration of the multi-rule chart. The abbreviations used in this figure are
described in Table B-22 on page B-155.

Control values X and Y

No
1-2SD Inside control range

Yes

No
No No No No No No No No
1-2.5SD 1-3SD 2-2SA R-4SD 2-2SW 4-1SA 4-1SW 10XA 10XW

Yes Yes Yes Yes Yes Yes Yes Yes Yes

Outside control range (error message)

Figure B-85 Application of multi-rule Shewhart-type method in realtime QC

Configuration of realtime QC Configure realtime QC in Realtime QC window (QC > Individual > Realtime QC):
Choose Select to specify control (X) and control (Y) for each relevant test. Then,
choose Rules to select the rules.

Only QC results of active reagents are evaluated.

e For more details see Configuring realtime QC on page B-157.

The following table briefly explains all rules that are selectable for realtime QC and
lists the corresponding alarms.
e For more details, refer to the COBI CD.

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QC Individual screen

Rule Order Judgement Judgment area Alarm

1-2SD 1 Either X or Y data 1-2SD None
Y
value is above +2SD
or below -2SD. 2SD
X

1-2.5SD 2 Either X or Y data 1-2.5SD Q2.5SD

Y
value is above +2.5SD
or below -2.5SD. 2.5SD

1-3SD 3 Either X or Y data 1-3SD Q3SD

Y
value is above +3SD
3SD
or below -3SD.
X

2-2SD 4 Both of X and Y data 2-2SA S2-2Sa

Y
values are above
3SD
+2SD or below -2SD. 2SD
X

6 The last two X or Y 2-2SW S2-2Sw

Y
data values are above
-2SD
2SD

+2SD or below -2SD.

2SD
X
-2SD

R-4SD 5 One of X and Y data R-4SD R-4SD

Y
value is above +2SD
3SD
and the other is below 2SD
-2SD. X

Table B-22 QC evaluation by Shewhart multi-rule method and corresponding alarms (Sheet
1 of 2)

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QC Individual screen

Rule Order Judgement Judgment area Alarm

4-1SD 7 The last two X and Y 4-1SA S4-1Sa
Y
data values are above
+1SD or below -1SD.
(Total 4 values) 1SD
X

-1SD
8 The last four X or Y 4-1SW S4-1Sw
Y
data values are above

-1SD
1SD
+1SD or below -1SD.
1SD
X
-1SD

10X 9 The last five X and Y 10XA S10Xa

Y
data values fall on the
+ or - side of the
mean value. (Total X
10 values)

10 The last ten X or Y 10XW S10Xw

Y
data values fall on the
+ or - side of the
mean value. X

Table B-22 QC evaluation by Shewhart multi-rule method and corresponding alarms (Sheet
2 of 2)

Deselecting realtime QC In cases where quality control using one QC sample is conducted instead of realtime
QC, specify None for X and Y corresponding to each analytical item and enter 0 for
SD. If in QC > Install the SD value is 0, a realtime QC check is not performed.

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QC Individual screen

Configuring realtime QC

Choose QC > Individual > Realtime QC to display the Realtime QC window.

Figure B-86 Realtime QC window

This window shows a diagram with the QC results for a selected test and a selected
pair of controls. The diagram is scaled to the target SD of control (X) and control (Y),
respectively. The newest QC result is shown in red.

Select Choose this button to assign two controls—control (X) and control (Y)— to be
evaluated by the multi-rule method.

Rules Choose this button to select rules used to evaluate the QC results. A pair of controls is
compared against a known standard deviation (SD) and mean. If one or both of the
controls fail a rule, the analyzer continues applying the testing criteria for all selected
rules. When at least one rule violation is found, the corresponding data alarm is
issued.

Figure B-87 Select Rules window

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QC Individual screen

The following symbols are used in the realtime QC plot:

Normal: Without QC errors

Random: Random QC errors

System: System QC errors

With intermediate QC errors

Reject Choose this button to reject realtime QC results that have specific data alarms
attached. Affected result points are removed from the plot.

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QC Individual screen

Accumulation of QC results

At the end of daily operation, QC measurement data should be accumulated. There

are two accumulation methods available: Mean-R and X-R. The choice for one or the
other method is made under Utility > System (Page 1/5) > QC Setting.
e For an explanation of the two accumulation methods, see
Accumulation of QC measurement data on page B-145.

System settings for QC accumulation

Choose Utility > System (Page 1/5) > QC Setting to display the QC Setting window.

Figure B-88 Utility > System (Page 1/5) > QC Setting window

Accumulation Method Select one of the two accumulation methods, Mean-R or X-R, from this box.
e See Accumulation of QC measurement data on page B-145.

QC Calculation If the accumulation method is Mean-R, select one of the two calculation methods,
DayToDay or Overall, from this box to specify how mean and SD values are calculated
in the cumulative QC.
This box is not available if X-R is selected in the Accumulation Method box.

Accumulating QC results

a To accumulate QC data
1 Select the data to be accumulated from the list on the QC > Individual screen.
2 Choose Accumulate.
3 If Mean-R is set as accumulation method, go to step 4.
If X-R is set as accumulation method, type the consecutive number of the QC
results to be used for the accumulation in the box or type 0 (zero) to transfer the
mean value; then choose OK.
4 In the confirmation window choose OK to accumulate the selected data.
After accumulation the corresponding data are deleted from the QC > Individual
screen and a new standard deviation (SD) and mean value is calculated and
displayed on QC > Cumulative.

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QC Cumulative screen

QC Cumulative screen

To display this screen choose QC > Cumulative.

Figure B-89 QC > Cumulative screen

The QC > Cumulative screen lists all accumulated QC results.

The list can be sorted by test name and control name. The table below explains
columns whose meaning is different from that on the QC > Individual screen:

N Number of accumulations (max. 500)

Mean Accumulated mean for each test (using the accumulation method selected
on Utility > System > QC Setting)

e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

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QC Cumulative screen

QC measurements
displayed in… performed displayed in…

Data Review QC Individual

Routine view

Delete All Accumulate

transfer to… transfer to…

Data Review QC Cumulative

QC view

Delete All Delete Delete

o Deletes QC in QC View o Deletes QC in QC View o Deletes QC in QC

o Deletes QC in QC Individual o Deletes QC in QC Cumulative
Individual

Recommendation
How to handle QC measurements in order to keep as little QC data as possible

Data Review QC Individual Data Review QC Cumulative

Routine view QC View

Delete All Accumulate Delete All Delete

Figure B-90 Relation between Data Review screen and QC measurements

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10 QC cobas c 311 analyzer
QC Control screen

QC Control screen

The QC > Control screen provides an overview of all controls that are downloaded
and assigned to a position on the sample disk.
When working with barcodes, controls are automatically identified. In case controls
are processed in non-barcode mode, it is necessary to assign a disk position number
for each control. The current position assignment is listed on the QC > Control
screen.
Choose QC > Control to display this screen.

Figure B-91 QC > Control screen

To provide additional assignments or remove existing assignments follow the

procedure below.

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QC Control screen

a To assign a control to a specific position

1 On QC > Control choose Position Assignment.

Figure B-92 QC > Control > Position Assignment window

2 On the Position Assignment window select the control from the list on the left and
an unassigned disk position from the list on the right.
3 Choose Assign to register the new assignment.
4 To remove an existing assignment select the concerned disk position from the list
on the right and choose Remove.
5 Choose OK to save the changes and close the window.

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QC Install screen

QC Install screen

The following sections explain certain tasks associated with the QC > Install screen
screen. Not all tasks are described but the most important ones.
To display this screen choose QC > Install.

Figure B-93 QC > Install screen

Use this screen to add and delete controls from the analyzer and to assign control
values.
The list on the left of the screen displays all controls that are installed on the analyzer.
For all installed controls the control name is highlighted in green. Up to a 100
controls can be installed on the analyzer.
e For information about particular tasks associated with this screen, see:
Loading control data on page B-165
Editing control values on page B-168
Activating control tests on page B-169
e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.

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QC Install screen

Loading control data

Control data for all available applications can be downloaded to the analyzer from
cobas link. An operator ID of supervisor level or higher is required for this operation.
This operation is a part of the installation process for a new application.
e For an overview of the complete installation process of a new application, see:
Loading or updating applications on page B-174

o In case controls are used without barcodes, assign the control positions manually.
o Controls may be added to the analyzer but the control tests will not run until they are
activated on the QC > Install screen.

a To download control data from cobas link

1 Choose QC > Install > Download to open the Download window.

Figure B-94 Download window for control data

2 Select one of the available search options (Required Item, Control Name, Lot
Number, or Release Date).
o The option Required Item refers to control data that has not been found on
the analyzer at the time of setting controls into the analyzer.
o The option Release Date refers to the date when the control data was released
by Roche.
3 Choose Search to start searching for the selected criteria. The search results are
displayed.

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10 QC cobas c 311 analyzer
QC Install screen

Figure B-95 Download window with search results

In the column Note you can find additional information about the control such as
reason for change.
To change the order of the list select the Sort By option.
4 Select the Selection check box of each list item to be downloaded.
5 Choose Download and confirm with OK.

Figure B-96 Confirmation window

6 Choose OK to start the download process.

All necessary information (such as applications covered by the control, target
mean values, and target SD values) is automatically stored on the analyzer.
7 To run control tests with a newly installed control it is necessary to activate these
tests: Select the tests from the list on the right in the QC > Install screen and
choose Activate Test. The test name is highlighted in green when a test is activated.
e See Activating control tests on page B-169.

If necessary it is possible to edit the downloaded target values and/or confidence

limits.
e See Editing control values on page B-168.

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QC Install screen

a To add controls manually (without cobas link)

1 Select a blank row in the control list on the QC > Install screen.
2 Choose Add.
3 Type all necessary data in the Add Control window.
The Material Code range is from 801-999.

Figure B-97 Add Control window

4 Choose OK. The new control appears on the control list.

To run control tests with the newly installed control it is necessary to manually
enter the target values for each test and then to activate these tests.
5 Choose Edit to enter target mean, target SD, and confidence limits if necessary.
Then choose Activate Test to activate the tests for the new control.
e For more details see:
Editing control values on page B-168
Activating control tests on page B-169

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10 QC cobas c 311 analyzer
QC Install screen

Editing control values

Control values can be edited on the QC > Install screen. You can use this function, for
example, if an Important Note concerning reassigned target values for a particular lot
of controls is released. Instead of downloading the control values from cobas link you
may also edit them manually.

a To edit control values

1 On the QC > Install screen choose the name of the control to be edited in the
Control list on the left side of the screen.
2 Choose Edit to display the Edit Control window.

Figure B-98 Edit Control window

3 Select the test to be edited from the list.

4 Type the new target mean and SD (standard deviation) values, cumulative and
individual, in the appropriate text boxes on the right side of the screen.
If the test uses this control for its QC Violation assessment, the Calculate button is
active; if not, go to step 6.
e For more information on QC violation, see
QC-triggered calibration (QC Violation) on page B-118.

5 Choose Calculate to recalculate the confidence limits on the basis of the edited
target and SD values and the QC violation rule (set under Utility > Application >
Calib.).

In case target and SD values are edited or entered manually, the calculation of confidence
limits is achieved by choosing the Calculate button. However, the confidence limits can
also be typed directly into the text boxes under Confidence Limit.
The Calculate button and the boxes High and Low are not available if the selected test is
not configured for QC Violation.

6 Choose Update to update the window.

7 Repeat steps 3 to 6 for all tests assigned to this control that need to be edited.
8 Choose OK to save the changes and close the Edit Control window.

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QC Install screen

Incorrect results due to wrong control values

If you manually edit control values, you must ensure that the QC results are correct.
CAUTION Perform QC measurements before you resume routine operation.

9 Perform QC measurements for all tests assigned to the edited control.

No update of manually edited control values

In case a value has been manually edited, this value will not be updated when you
download new control values from cobas link.
If you want to return to the original control value, delete this control data and download it
again from cobas link. Perform QC measurements before you resume routine operation.

Activating control tests

Tests can only be activated when the analyzer is in Standby.

a To activate control tests

1 On the QC > Install screen choose the appropriate control name in the list box on
the left side of the screen.
2 Choose the test to be activated in the list on the right of the screen.
3 Choose Activate Test. The test name is highlighted in green when the test is
activated.
4 Repeat step 2 and 3 for all tests to be activated for that control.

To activate a test the test must have target and SD values entered for the control.

e See Editing control values on page B-168.

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10 QC cobas c 311 analyzer
Programming auto QC measurements

Programming auto QC measurements

When a control interval time is specified on Utility > Application > Range for an
application, it is possible to let the analyzer automatically perform necessary QC
measurements with controls that permanently reside in the sample disk.
At intervals of 30 minutes, the instrument checks whether a preset time is exceeded or
not. If a time period after the last QC measurement exceeds the preset time, the
instrument issues a recommendation of execution of QC measurement.
In case an automatic QC selection was made and quality control samples are on the
sample disk, the instrument will carry out automatic QC measurement by
intervening the current measurement of routine samples.
An on board stability time of QC samples on the instrument can be set for each test.
An alarm will be issued if the on board stability time of QC samples is exceeded.

a To program auto QC measurements

1 Choose Utility > Application > Range.
2 Select the Control Interval Time check box for the relevant tests and specify a
control interval from 1 to 1000 hours.
3 Select the On Board Stability Time check box and specify an on board stability
time for the QC sample from 1 to 99 hours.
4 Choose QC > Install.
5 Select a quality control sample to be subjected to automatic QC measurement.
The selected quality control sample is highlighted.
6 Choose Select Auto QC. The asterisk mark (*) is indicated at the upper left of the
control number concerned.

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cobas c 311 analyzer 11 Configuration
Table of contents

Configuration

This chapter describes the configuration of the cobas c 311 analyzer for customers.

In this chapter Chapter 11

Application ............................................................................................................. B-173
Overview ........................................................................................................... B-173
Loading or updating applications ................................................................... B-174
Loading application parameters ................................................................ B-174
Loading the HbA1c Whole blood application ................................................ B-176
Overview ..................................................................................................... B-176
Installing and configuring the application ................................................ B-178
Notes for the use of the application ........................................................... B-179
Description of application parameters ............................................................ B-180
Description of application parameters - Analyze tab ..................................... B-180
Description of application parameters - Calib. tab ........................................ B-182
Auto masking .............................................................................................. B-183
Auto Calibration ......................................................................................... B-183
Description of application parameters - Range tab ........................................ B-185
Unit of measure .......................................................................................... B-186
Report name ............................................................................................... B-187
Automatic Rerun ........................................................................................ B-187
Technical limit (photometric tests) ........................................................... B-187
Repeat limit ................................................................................................. B-188
Qualitative fields (photometric tests) ........................................................ B-189
L, H, I fields (serum index check) ............................................................. B-189
Expected values ........................................................................................... B-189
System configuration ............................................................................................. B-191
Programming system parameters .................................................................... B-192
Using patient IDs .............................................................................................. B-194
Generating multiple results for a single test .................................................... B-195
Host Communication settings ......................................................................... B-196
Communication Setting tab ....................................................................... B-196
Text Setting tab ........................................................................................... B-196
Result Upload Setting tab ........................................................................... B-197
Assigning tests or profiles to test keys ............................................................. B-198

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Table of contents

Maintenance / Pipe Setting / Power Up Pipe buttons .................................... B-200

Sample Disk Setting button ............................................................................. B-200
Using false bottom tubes .................................................................................. B-201
Module Set .............................................................................................................. B-202
Assigning a test ................................................................................................. B-203
Calculated Tests ...................................................................................................... B-204
Programming calculated tests .......................................................................... B-204
Programming compensated tests .................................................................... B-207
Special Wash ........................................................................................................... B-209
Programming a reagent probe wash ................................................................ B-209
Programming a cell wash ................................................................................. B-211
Programming a sample probe wash ................................................................ B-212
Report Format ........................................................................................................ B-214
Customizing patient report format ................................................................. B-214
Comparison of data monitor format and report format ............................... B-216
Data Print report (monitor format) .......................................................... B-216
Data Print report (report format) ............................................................. B-216
Saving system parameters ...................................................................................... B-217
Restoring system parameters ................................................................................. B-219

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cobas c 311 analyzer 11 Configuration
Application

Application

When the system was installed by your Roche Service representatives all required
applications are installed. This section explains how to add new applications and
configure specific application parameters.

Overview

General information Up to 100 tests (86 photometric tests, 3 electrolyte tests, 8 calculated tests, and
3 serum indices) can be installed on the analyzer.
The following test numbers are fixed:

Test number Test name

87 Na
88 K
89 Cl
90 Serum index L
91 Serum index H
92 Serum index I
Table B-23 Fixed test numbers

Loading a new application Before you can load a cobas c pack of a new application onto the analyzer, the
application parameters have to be downloaded from cobas link. Otherwise, the
cobas c pack will be rejected by the system.
e Refer to the following sections to get information about:
cobas® link on page A-31
Loading application parameters on page B-174
Description of application parameters on page B-180

A description for loading Development Channel applications is available on cobas link.

Refer to the Instructions for Use for the cobas c pack MULTI. Please contact your Roche
representative for more information.

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11 Configuration cobas c 311 analyzer
Application

Loading or updating applications

The cobas c 311 analyzer requires application parameters, calibrator data, and control
data for each application. All data required for a new application can be downloaded
from cobas link. Existing applications can be updated via cobas link.
To be able to use a new application on the analyzer, you have to perform the following
installation procedures:
1. Loading application parameters, customize the default parameters if necessary
e For more information, see:
Loading application parameters on page B-174
Description of application parameters on page B-180
2. Loading calibrator data
e See Loading calibrator data on page B-131
3. Loading control data
e See Loading control data on page B-165.
4. Assigning sample disk positions for calibrators and controls (only necessary when
working with non-barcoded calibrators or controls)
e For more information, see:
To assign a calibrator to a specific position on page B-138
To assign a control to a specific position on page B-163
5. Adding special washes if applicable
e See Special Wash on page B-209
6. Loading cobas c packs
e See Loading cobas c packs on page B-45

Loading application parameters

The following procedure describes how you can download new or update existing
application parameters from cobas link. It can be performed by an operator with
administrator level password only.

a To download application parameters from cobas link

1 Choose Utility > Application > Download to open the Download window.

Figure B-99 Download window for application parameters

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Application

2 Select one of the available search options (Required Item, Application Code,
Application Name, Cassette No., or Release Date).
o The option Required Item refers to an application that has not been found on
the analyzer at the time of reagent barcode reading.
o The option Release Date refers to the date when the application parameters
were released by Roche.
3 Choose Search to start searching for the selected criteria. The search results are
displayed.

Figure B-100 Download window with search results

In the column Note you can find additional information about the application
such as reason for change.
To change the order of the list select the Sort By option.
4 Select the Selection check box of each list item to be downloaded.

If the required item is not contained in the list, you can go to the next page by clicking on
the page number (e.g., 1/2) in the upper right corner of the list.

5 Choose Download and confirm with OK.

Figure B-101 Confirmation window

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Application

The short test name assigned to the application automatically displays in the Test
Name box. However, it is possible to assign a different test name (up to
5 characters) if needed.
It is also possible to change the channel number. This may be needed to change
the pipetting sequence.
6 Choose OK to start the download process.
7 Choose OK to read all parameter information.
The application parameters of the downloaded application are displayed on the
Application screen. Some parameters are user-definable.
e See Description of application parameters on page B-180.

Loading the HbA1c Whole blood application

This section describes the necessary steps for using the HbA1c whole blood
application on the analyzer.
Information on the general installation procedure for a new application is given in the
previous section.
e See Loading or updating applications on page B-174

Overview

Necessary applications To obtain results for HbA1c (%), the following applications are necessary:

Application/Reagent Short name Application code (ACN)

Hemolyzing Reagent A1CD2 952
Hemoglobin Hb-W2 870
Hemoglobin A1c A1-W2 880
% Ratio of Hemoglobin/Hemoglobin A1c RWI2 890
Table B-24 Applications and reagents of the HbA1c (%) application

Two cassettes are necessary for the HbA1c test. One cobas c pack contains the
hemolyzing reagent (application code number 952). The application code numbers
870 and 880 refer to the second cobas c pack which contains reagent for both
applications (Hb-W2 and A1-W2).

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Application

Reaction course The following figure shows the reaction course of the Whole blood application:

1 Sample pipetting 2 Hemolizing process 3 Hemoglobin analysis 4 Hemoglobin A1c analysis

For pipetting EDTA whole blood EDTA whole blood sample is Hemolized (prediluted) sample R3 (A1-W2 reagent) is added.
sample, the sample probe lowers pipetted into predilution cuvette and R1 (Hb-W2 reagent) is o 2 Point assay
down to 70% of the filling volume. and is hemolized with hemolizing pipetted. o Cycle 24-57
reagent (A1CD2). o 1 Point assay
o Cycle 1-23

EDTA whole blood A1CD2 reagent Hb-W2 reagent A1-W2 reagent

70%

Reaction cuvette Reaction cuvette

30%
Predilution cuvette

Hemoglobin analysis Hemoglobin A1c analysis

Absorbance

o Sample (prediluted) + o R3 (A1-W2 reagent) is added

R1 (Hb-W2 reagent)

R3
S, R1

0 23 Cycles 57

Figure B-102 Reaction course of the HbA1c application

Result calculation The result for the Hemoglobin A1c analysis is calculated according to IFCC
standardization:
A1-W2 HbA1c
Equation B-1 RWI2 = ----------------- ⋅ 100% (that means HbA1c % = ------------------ ⋅ 100% )
HB-W2 Hb

This calculated test can be downloaded as application RWI2 (Application code 890)

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11 Configuration cobas c 311 analyzer
Application

Installing and configuring the application

To use the HbA1c application on the analyzer, you have to perform the following
installation procedures:
1. Loading application parameters for the following applications:
O Hemoglobin (Hb-W2, ACN 870)
O Hemoglobin A1c (A1-W2, ACN 880)
O % Ratio of Hemoglobin/Hemoglobin A1c (RWI2, ACN 890)
O Hemolyzing Reagent (A1CD2, ACN 952)
e See Loading application parameters on page B-174
2. Loading calibrator data for the following calibrator:
O C.f.a.s HbA1c (674)
e See Loading calibrator data on page B-131
3. To improve the fit of nonlinear HbA1c calibration curve, a constant and lot
independent offset of 0.6 g/dl was added to all calibrator values. This offset is
already included in the assigned HbA1c calibrator target values and needs to be
subtracted from the obtained Hemoglobin A1c results.
Please ensure that b = -0.6 is assigned for Hemoglobin A1c (A1-W2) in
Calibration > Status > Instrument Factor.
4. Loading control data for the following controls:
O HbA1c Control N (357)
O HbA1c Control P (358)
e See Loading control data on page B-165
5. Setting the decimal places of the calculated test RWI2:
Roche recommends to report the results with one decimal place.
e For more information on configuring the decimal places of a calculated test, see:
To set range parameters on page B-205
6. Assign the RWI2 test to a key on the Suprnt tab (Utility > System (Page 1/5) > Key
Setting).
e For more information, see: To assign a test or a profile to a key on page B-199.
7. Loading the two cobas c packs (A1CD2 and A1C2) for the following applications:
O Hemolyzing Reagent A1CD2 (ACN 952)
O Hemoglobin A1C2, containing Hb-W2 (ACN 870) and A1-W2 (ACN 880)

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Application

Notes for the use of the application

Result calculation according to Roche provides the application RWI2 (Application code 890) to calculate the
DCCT/NGSP standardization Hemoglobin A1c % results according to IFCC standardization.
To report the results according to DCCT/NGSP standardization, you have to
configure the calculated test ACN 890 (Formula tab of the Calculated Test Formula
window):
A1-W2
Equation B-2 RWD2 = ----------------- ⋅ 87.6 % + 2.27
HB-W2

Sample container, sample For processing the HBA1c whole blood application only sample tubes with the
pipetting following specifications can be used:
o 13 mm x 75 mm (Standard tubes)
o 13 mm x 100 mm
o 16 mm x 75 mm
o 16 mm x 100 mm
For HbA1c whole blood QC measurements, sample cups directly placed on the
sample disk can be used.

Use the sample type Supernatant for HbA1c whole blood measurements.

Clot detection Clot detection is automatically deactivated when pipetting whole blood samples.

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11 Configuration cobas c 311 analyzer
Application

Description of application parameters

It is possible to change some of the default parameters installed with an application to

suit individual laboratory practice. These procedures can be performed by an
operator with administrator level password only.

Incorrect results due to modifying application parameters

Changing any application settings may affect the validity of results.
CAUTION Check the new settings before using it.

e For instructions on changing default application parameters on the Calib. tab, see:
To define calibration timeouts on page B-184
To define application auto masking on page B-183
e For instructions on changing default application parameters on the Range tab, see:
To change the unit of measure for an application after calibration on page B-186
To define application report name on page B-187
e To change the technical limit (photometric tests) on page B-187
To change the repeat limit on page B-188
To change qualitative fields (photometric tests) on page B-189
To change expected values on page B-190
To change default settings on page B-190

Description of application parameters - Analyze tab

The following sections explain certain settings associated with the Analyze tab on
Utility > Application screen. Not all settings are described, but the most important
ones.
To display this screen, choose Utility > Application > Analyze.

Figure B-103 Analyze tab on Utility > Application screen (photometric tests)

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cobas c 311 analyzer 11 Configuration
Application

Sample Volume area It is possible to perform automatic dilution on patient samples. Usually the first run is
performed with the normal sample volume settings.
The dilution settings are displayed as follows:

A B C

Photometric test
A Sample volume [µL] (undiluted)
B Volume of the diluted sample [µL]
C Diluent volume [µL]

Figure B-104 Sample Volume area

Example for normal sample volume (Magnesium (MG) test):

o 2.0 µL
A rerun is performed with decreased or increased volume settings. If a >Test Flag
appears (technical limit high) the decrease sample volume settings is used for
automatic rerun.
Example for decreased sample volume (Magnesium (MG) test):
o 15 µL - Sample volume of the undiluted sample
o 135 µL - Diluent volume
o 10 µL - Sample volume of the prediluted sample
The sample volume of 15 µL is diluted with 135 µL diluent (0.9% NaCl) and
afterwards 10 µL of the diluted sample is taken for rerun.

If a dilution is selected on the Workplace > Test Selection screen, it takes priority.

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Application

Description of application parameters - Calib. tab

The following sections explain certain settings associated with the Calib. tab on
Utility > Application screen. Not all settings are described, but the most important
ones.
To display this screen, choose Utility > Application > Calib.

Figure B-105 Calib. tab on Utility > Application screen (Photometric test)

Figure B-106 Calib. tab on Utility > Application screen (ISE test)

e For instructions on changing default application parameters on the Calib. tab, see:
To define application auto masking on page B-183
To define calibration timeouts on page B-184

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Application

Auto masking
If Auto Masking is selected, the particular test requiring calibration due to a failed
calibration will be masked automatically.

a To define application auto masking

1 Choose Utility > Application > Calib.
2 Select the test to be edited from the Test list on the left.
3 Select the Auto Masking check box to select the test for auto masking.
4 Repeat steps 2 and 3 for all necessary tests.
5 Choose Save to save the changes.

To activate the auto masking function, select the Auto Masking check box on Utility >
System (Page 2/5) > Calib. Mask Setting.

Auto Calibration
Calibration can be requested automatically in the following cases:
o Changeover (Cassette or lot change): If a new cobas c pack or a new reagent lot is
loaded on the analyzer.
o Timeout: If the calibration time period for a cobas c pack or the reagent lot has
expired.
o QC Violation: If a QC result falls outside the confidence limit.
When you load a new application onto the system, the changeover- and time-
triggered calibration is activated by default. If you intend to work with QC-triggered
calibration, you must configure the QC violation parameters and activate QC-
triggered calibration (QC Violation).
e For more information, see:
To activate QC violation on page B-183
To define calibration timeouts on page B-184

a To activate QC violation
1 On the Calib. tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 Select QC violation.
3 Select the Calibration update method (Blank, Span, 2 Point, or Full) from the
Method list box.
e For more information about calibration methods, see:
Calibration concept on page B-117

4 Select the rule for checking the QC measurement from the Rule list box.
Calibration will be recommended if a QC result falls out of the specified range
(expressed in multiples of one standard deviation).
5 Select the controls that should trigger a calibration.
Up to three controls can be assigned. If any of the QC results falls out of the
specified range, a new calibration is recommended.

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11 Configuration cobas c 311 analyzer
Application

For each of the assigned controls, an individual confidence interval must be

specified. The confidence interval can be calculated automatically using the
standard deviation selected in the Rule field or it can be entered manually.
e For more information, see Editing control values on page B-168.

Important notes for QC violation:

o At least one control must be selected for Control 1, 2, or 3.
o If a control is deleted, the setting will be changed to None automatically.
o Make sure that at least one control selection for QC violation is other than None.
Otherwise the QC violation function keeps activated if the corresponding radio button
is selected but can not be carried out.

e For more information about calibration, see:

Triggers for automatic calibration requests on page B-118
Calibration rules for the photometric unit on page B-120.

a To define calibration timeouts

1 On the Calib. tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 Select Timeout.
3 Define the required calibration method and the timeout period:
o For photometric applications:
O Select the calibration method for lot calibration from the corresponding
list box.
O Type the required timeout period for lot calibration in the corresponding
text box and select the time unit from the corresponding list box.
O Repeat the last two steps for cassette calibration.
o For ISE applications:
O Select the calibration method from the corresponding list box.
O Type the required timeout period for ISE calibration, in days, in the
corresponding text box.
4 Choose Save to save the changes.

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Application

Description of application parameters - Range tab

The following sections explain certain settings associated with the Range tab on
Utility > Application screen. Not all settings are described, but the most important
ones.
To display this screen, choose Utility > Application > Range.

Figure B-107 Range tab on Utility > Application screen (Photometric test)

Figure B-108 Range tab on Utility > Application screen (ISE test)

e For instructions on changing default application parameters on the Range tab, see:
To change the unit of measure for an application after calibration on page B-186
To define application report name on page B-187
To define application automatic rerun on page B-187
To change the technical limit (photometric tests) on page B-187
To change the repeat limit on page B-188
To change qualitative fields (photometric tests) on page B-189
To change expected values on page B-190
To change default settings on page B-190

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11 Configuration cobas c 311 analyzer
Application

Unit of measure
The current unit of measure is displayed in this field. The unit has first been selected
when the application was downloaded from cobas link.
Changing the unit also recalculates the concentration based application data, for
example, repeat limit, expected value. The list box can offer up to four different units.

a To change the unit of measure for an application after calibration

Incorrect calibration and QC results

You can change the unit of measurement after an application has been installed. You can
CAUTION only change the unit once after the test in question has been calibrated. We strongly
recommend deleting that test application and then reinstalling it.
After changing the unit of measurement, always recalibrate and run controls in order to
ensure no false results are reported.

1 Backup the database and delete patient data (System Overview > Sample Data
Clear > Backup and Clear).
If Sample data clear is executed, all the records of the samples are deleted and QC
data are moved to the QC view.
e For details see Sample Data Clear button on page B-41.

2 Unload all the cobas c packs for that test (Reagent > Setting > Unloading).
e For details see Unloading cobas c packs on page B-47.

3 Delete the test application (Utility > Application > Analyze).

4 Reinstall the test application (Utility > Application > Download).
e For details see Loading or updating applications on page B-174.

5 Change the unit of measure (Utility > Application > Range).

6 Load new cobas c packs.
e For details see To load a cobas c pack on page B-45.

Any cobas c packs for this test that were already in use on the analyzer cannot be
reloaded onto the analyzer after the test has been deleted.

7 Install the calibrator values for this test under Calibration > Install > Download.
e For details see Loading calibrator data on page B-131.

8 Install the control values for this test under QC > Install > Download.
e For details see Loading control data on page B-165.

9 Calibrate the test and perform control measurements.

e For details see Requesting calibration and QC and printing load lists on page B-48.

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Application

Report name
If specified, the report name will be used for printouts instead of the test name. For
the example in Figure B-107 on page B-185, Test02 will be printed out for SGLUC
reports.

a To define application report name

1 On the Range tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 Type the desired report name for the test in the Report Name text box.
3 Choose Save to save the changes.

Automatic Rerun

a To define application automatic rerun

1 On the Range tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 Select Automatic Rerun.
3 Choose Save to save the changes.
e For more information, see
Processing reruns on page B-62
Rerun list on page D-41

o If automatic rerun is selected, the sample has to remain on the sample disk until the
results of the sample are available.
o To perform automatic reruns, the automatic rerun function must be selected (Start
(global button) > Automatic Rerun).

Technical limit (photometric tests)

A lower and upper technical limit is set for each application. Recommended values
are transferred via cobas link.
For photometric tests: Any result below the lower technical limit (<Test data alarm) is
repeated with increased volume. Any result over the upper technical limit (>Test data
alarm) is repeated with decreased volume.
For ISE results which are below the technical limit (<Test data alarm), an automatic
rerun is performed with the same sample volume 9.7 µL. When the result is above the
upper technical limit (>Test data alarm), the rerun is also done with the same sample
volume as for the first run. Only ISE results for urine samples can be rerun-ed with
decreased sample volume (6.5 µL), but this can only be requested manually.

a To change the technical limit (photometric tests)

1 On the Range tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 In the first Technical Limit box, type the lower limit.
In the second box, type the upper limit.
3 Choose Save to save the changes.

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Application

Repeat limit
For each test a clinical relevant range can be typed in here. If the test result is outside
this limit but inside the Technical Limit of the application, the test is repeated using
the same sample volume and dilution as in the first run.

a To change the repeat limit

1 On the Range tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 In the first Repeat Limit box, type the lower limit of the range.
In the second box, type the upper limit of the range.
3 Choose Save to save the changes.

o The concentration range of the Repeat Limit must lie within the Technical Limit.
o A Repeat Limit Flag (>Rept / < Rept) is only added to a result if this is enabled in
Utility > System (Page 1/5) > Alarm.

4 Choose Alarm on the Utility > System (Page 1/5) screen.

Figure B-109 Alarm Setting window

5 Verify the settings of the Repeat Limit Flag and the With Automatic Rerun check
boxes. If both are selected, an automatic rerun will be performed if the result is
outside the repeat limit (>Rept, <Rept data alarms).
e For more information, see
Processing reruns on page B-62.

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Application

Qualitative fields (photometric tests)

This function is important for DAT (drug abuse testing) especially. Qualitative
reporting can be chosen instead of quantitative reporting for each photometric test.
In the text boxes of the first column (1-5) the upper limit concentration range has to
be entered. Any result less than or equal to the value defined here will be printed with
the text defined in the second box.
If a result is higher than range (5) the text defined in text box (6) is taken.

a To change qualitative fields (photometric tests)

1 On the Range tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 Select the Qualitative check box to activate the qualitative fields.
3 Type the correct information in the first qualitative text box for (1).
4 Type the symbol that will be printed on the report in the second text box for (1).
5 Repeat steps 3 to 4 for numbers (2) to (6).
6 Choose Save to save the changes.

L, H, I fields (serum index check)

The serum index function can be defined individually for each test. In the serum
index fields L (lipemic), H (hemolytic), I (icteric) the ranges that are loaded with the
application are displayed.
If at least for one serum index field a value other than 0 is entered, serum index
measurement is performed. If 0 is entered, the corresponding serum index is not
calculated. The serum index flag (>Index) does not trigger a rerun.

Expected values
Expected values area is used to define the normal range for men and women in three
different age groups. If the result for this test falls outside the ranges entered here, the
system issues an alarm (H, L (only on printouts)). The last row of the field does not
allow an age limit to be defined. These expected values include patients older than the
upper limit of the second age group.

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Application

A C
B D
E

A Age threshold 1 C Range 1 (ages < age threshold 1)

B Age threshold 2 D Range 2 (ages < age threshold 2)
E Range 3 (ages > age threshold 2)

Figure B-110 Expected values

a To change expected values

1 On the Range tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
Now, you can change the settings in the Expected Values area.

a To change normal-value ranges and corresponding age

1 In the Expected Values area, choose the first text box and enter a patient age for
cutoff of the first expected value range. Then select the unit (Day, Month, Year) for
that age in the list box.
2 Type the lower and upper normal-values for males in the Male area in the last
2 text boxes in the row for the specified test.
3 Repeat steps 1 and 2 for the second age cutoff in the second row of text boxes in
the Male area.
4 In the third row of text boxes, type the lower and upper normal-values for males
of all ages above the second age cutoff.
5 Repeat steps 1 to 4 for female age cutoff ranges.
Now, you can change the default settings.

a To change default settings

1 In the Default Sex area, select either the Male or Female option as the default if no
sex is specified.
2 In the Default Range area, select the default age range (Range 1, Range 2 or
Range 3) to be used if no age range is specified.
3 Choose Save to save the changes.

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System configuration

System configuration

This section explains how to perform certain tasks associated with the Utility >
System menu.
e For a complete description of all fields and commands under the System menu, refer to the
Online Help.

The entire system parameter settings should be set before the other settings (control,
calibrator settings).

To display this screen, choose Utility > System.

Figure B-111 Utility > System screen

e For information about particular tasks associated with this screen, see:
Programming system parameters on page B-192
Saving system parameters on page B-217
Restoring system parameters on page B-219

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System configuration

Programming system parameters

Many system parameter settings can be customized according to your laboratory’s

needs. Your Roche technical representative programs these according to your
specifications during installation.

After (re)programming system parameters, it is strongly recommended that you make a

backup disk. However, some items cannot be saved to disk.

e See Saving system parameters on page B-217.

You can adjust the following system parameter settings:

System parameter screen/window

Position Assignment(a) Utility > System
Printer Page Size Utility > System
Set Date / Time Utility > System
Screen Saver Setting Utility > System
Test Name Order Utility > System
Barcode Setting Utility > System
Print Dilution Ratio Utility > System
Start Cell No. Incremental Utility > System
Wash Sampling cycles Utility > System
Sample Reception Setting Utility > System
3rd Results Acceptance Utility > System
Define Alarm Settings Utility > System (Page 1/5) > Alarm
Define Host Communication Settings Utility > System (Page 1/5) > Host Comm.
Define Comment Titles Utility > System (Page 1/5) > Comment
Assign Test Keys Utility > System (Page 1/5) > Key Setting
Define Test Group Names Utility > System (Page 1/5) > Key Setting
Add/Edit a test Profile Utility > System (Page 1/5) > Key Setting >
Profile Setting
Define QC Settings Utility > System (Page 1/5) > QC Setting
Define Reagent Level Check Alarms Utility > System (Page 2/5) > Reagent Level
Check
Activate Calibration Mask Settings Utility > System (Page 2/5) > Calib. Mask
Setting
Maintenance Settings Utility > System (Page 2/5) > Maintenance
Setting
Pipe Settings Utility > System (Page 2/5) > Pipe Setting
Power Up Pipe Settings Utility > System (Page 2/5) > Power Up Pipe
Setting
Assign Operator IDs Utility > System (Page 3/5) > Operator ID
Define Check Digit Settings - Barcode Mode Utility > System (Page 3/5) > Check Digit
Define ISE Calib Setting Utility > System (Page 3/5) > ISE Calib Setting
Define Sample Disk Setting Utility > System (Page 3/5) > Sample Disk
(Number of STAT samples) Setting
Table B-25 System parameters (Sheet 1 of 2)
(a) Can only be edited in Patient ID mode (Barcode Setting)

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System configuration

System parameter screen/window

Check Diluents and Cleaners Utility > System (Page 3/5) > Dil. + Cln.
Setting
Activate Automatic Printout Utility > System (Page 4/5) > Automatic
Printout
Review By Exception Utility > System (Page 4/5) > Review By
Exception
False bottom tubes Utility > System (Page 5/5) > FBT Setting
Activate Automatic Rerun Start (global button)
Activate Host Communication Setting Start (global button)
Program Default Profiles Start (global button) > Default Profile
Set Alarm Sounds Alarm (global button) > Sound
Table B-25 System parameters (Sheet 2 of 2)
(a) Can only be edited in Patient ID mode (Barcode Setting)

1/5

2/5

3/5

4/5

5/5

Figure B-112 System parameters (administrator level)

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System configuration

Using patient IDs

By default, the analyzer uses Sample IDs. If there are several sample types of the same
patient, each sample has a different ID.
Using Patient IDs means to assign the same ID to all samples types (serum/plasma,
urine, CSF, and supernatant) of one patient. To distinguish the different sample types,
they have to be assigned to different position areas on the sample disk.

To assign positions, the Patient ID mode has to be activated first. The Change button in the
Position Assignment area will only be displayed in this mode. Therefore you have to delete
all data in the Data Review screen.

1 On the Utility > System screen, choose Change in the Barcode Setting area. The
Barcode Setting window is displayed.
2 Select Patient ID and choose OK.
3 On the Utility > System screen, choose Change in the Position Assignment area.
The Position Assignment window is displayed.

Figure B-113 Position Assignment window

Before performing this action, observe the following safety precaution:

o Incorrect results due to position mismatch on page B-4

4 With regard to routine and STAT samples, assign each of the positions for each of
sample types.

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System configuration

Generating multiple results for a single test

It is always possible to generate 2 results for each test: 1st run and rerun. Select the 3rd
Results Acceptance check box on Utility > System to expand the ability to generate
multiple results for a single test.

Description of 3rd Results When 3rd Results Acceptance is activated, it is possible to request a test more than two
Acceptance times after confirming a safety warning. Any third or subsequent result will overwrite
the previous rerun result.

Incorrect results due to sample mismatch

Be aware that in non-barcode mode there is a risk of sample mismatch.
CAUTION Do not exchange or remove samples.

The repeated rerun is only performed if the previous rerun result has been sent to the
Host. In case the previous result is not transmitted prior to the repetition request, the
sample is not pipetted.

Preconditions for 3rd Results Before activating 3rd Result Acceptance it is necessary to check the following
Acceptance conditions.

a To activate 3rd Results Acceptance

1 Choose Start (global button) to open the Start Conditions window.
2 Verify if in the Host Setting area, that the Host communication is enabled. If not,
choose Change, select the Communication On check box, and choose OK.
3 Choose Workplace > Data Review > Send To Host and send all results to the Host.
Then delete all data from the database by choosing Delete All.
4 Choose Utility > System (Page 1/5) > Host Comm. > Text Setting.
5 Select the Manual Rerun TS check box and choose OK.
6 Choose Utility > System (Page 1/5).
7 Select the 3rd Results Acceptance check box in the Other area.
8 Choose OK and confirm the warning message.
With this confirmation you allow the system to overwrite rerun results by third
and subsequent results.

Repeat Limit Flag / With When this feature is enabled, the system utilizes the repeat limit flag and repeat limit
Automatic Rerun values as defined under Utility > Application > Range. Whenever a sample result is
outside the specified repeat limit for a particular test, a data flag >Rept / <Rept is
attached to each result.
e For information on how to define the repeat limit, see: Repeat limit on page B-188.

When the Repeat Limit Flag check box is selected, the With Automatic Rerun check
box also is available. If it is selected as well, the particular test for this is sample is
repeated with the same sample volume as the in the first run.

To perform automatic reruns, the automatic rerun function must be selected (Start (global
button) > Automatic Rerun).

e For more information about the Alarm Setting window, refer to the Online Help for that
particular window.

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System configuration

Host Communication settings

The Host Communication Setting window is used to define all Host computer
interface parameters. The parameters are defined during installation by a Roche
Service engineer and should not be changed as this may cause data transferring
problems.
The Host Communication Setting window is divided into 3 tabs, which are described
in the following.

Communication Setting tab

Figure B-114 Host Communication Setting window - Communication Setting tab

Use this tab to define the Host computer communication settings.

e For a detailed description, refer to the Host Manual.

Text Setting tab

Figure B-115 Host Communication Setting window - Text Setting tab

Use this tab to define the text settings used for Host communications.
The abbreviation TS stands for Test Selection.
e For a detailed description, refer to the Host Manual.

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System configuration

Result Upload Setting tab

Figure B-116 Host Communication Setting window - Result Upload Setting tab

Use this tab to define the upload settings used for the transfer of result data from the
analyzer to the Host.

Option Meaning
by sample All results of one sample are collected before uploading
ISE/Chemistry ISE and all clin.-chem. results are uploaded separately
by Test (only for STAT samples) As soon as the result is available
Table B-26 Routine Sample Host upload setting

No Automatic Result Upload When this function is enabled, no result is uploaded in real time. In this case, the
results can be uploaded manually by selecting samples from the Workplace > Data
Review screen and choosing Send To Host.

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System configuration

Assigning tests or profiles to test keys

To display this window, choose Utility > System (Page 1/5) > Key Setting.

Figure B-117 Key Setting window

This window is used to assign tests or profiles to test keys. One test or profile can be
assigned to each test key. Tests can be assigned for up to 5 groups of 32 keys per
sample type. In total 160 test keys are available for each sample type.

a To define a group name

The group name can be defined individually, for example, TDM (therapeutic drugs
monitoring), DAT, or substrate.
1 Choose the sample type tab, for example, Ser/PL.
2 Select the Group tab (Group 1 - 5).
3 Type the name of the Group in the Group Name box.

The group name is not displayed on the Key Setting window. It is displayed in the Test
Selection screen.

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System configuration

a To assign a test or a profile to a key

1 Choose a key on the Key Setting window. The Test Key Assignment window is
displayed.

Figure B-118 Test Key Assignment window

2 Select a test or a profile from the list and choose OK.

o If you want to delete a test key assignment, select Undefined at the end of the list.
o Before you can select a profile, the profile has to be defined.

a To define a profile
Profiles are sample type specific, this means the sample type has to be selected.
1 Choose the tab of a sample type on the Key Setting window, for example, Ser/Pl.
2 Choose Profile Setting on the Key Setting window. The Profile Setting window is
displayed.

Figure B-119 Profile Setting window

A maximum of 20 profiles in total can be defined in the Profile Name list.

3 Select an empty row in the Profile Name list.
4 Type in the profile name in the Profile Name box.

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System configuration

5 Add the tests that should be included in the profile to the Assigned Test list.
6 Choose Update to update the information and choose OK to save the profile
settings.
7 If a profile is assigned to a key, the key is marked with a brown bar.

Maintenance / Pipe Setting / Power Up Pipe buttons

Configuration of Maintenance related items is described in the corresponding

maintenance chapters.
e For information, see:
Defining and editing maintenance types on page C-17
Defining and editing maintenance pipes on page C-11
Power Up Pipe function on page C-13

Sample Disk Setting button

Figure B-120 Sample Disk Setting window

Use this window to set the number of sample disk positions that are reserved for STAT
samples (0 to 53 positions). The assignment of the STAT positions is displayed on the
top left of the Utility > System screen.

At least one position should be reserved for a STAT sample!

If no position is reserved for a STAT sample and all positions are occupied by other
samples, the STAT sample can not be processed until another sample is removed from the
sample disk.

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System configuration

Using false bottom tubes

Use this window to define the dimensions of false bottom tubes/cup on non standard
tubes. The following measures must be defined:
o Container height - the length of the tube: 75 mm - 100 mm
o Bottom Level (see Figure B-122): 0.1 mm - (Container height - 20) mm
If you use tubes with conical bottom, select Conical Bottom.

Figure B-121 False bottom/Cup on non-Standard tube Setting window

When using false bottom tubes or cup on non-standard tubes, the distance between
the upper edge of the tube and the bottom level must be more than 20 mm.
90 mm (for example)
Container Height

> 20 mm

Bottom Level
15 mm (for example)

Figure B-122 False bottom tube dimensions

o Note that only one false bottom tube or non-standard tube can be specified.
o The analyzer automatically detects whether a false bottom tube is set in a sample disk
position. You do not need to assign positions for false bottom tubes.
o For exact specifications of the sample containers, contact its manufacturer.

a To assign false bottom tubes

1 Choose Utility > System (Page 5/5).
2 Choose the FBT Setting button.
3 Enter the specifications of the relevant sample container.

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Module Set

Module Set

This section explains how to perform certain tasks associated with entire modules
(photometric unit or ISE unit) rather than specific samples or tests. For the
cobas c 311 analyzer, the word module is used synonymously to unit.

The entire module set (module configuration, test assignment) should be performed before
the other settings (control, calibrator settings).

To display this screen, choose Utility > Module Set.

This screen can be accessed by an operator with service or administrator level
password only.

Figure B-123 Utility > Module Set screen

This screen is used to access the Test Assignment window.

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Module Set

Assigning a test

a To assign a test to the photometric or ISE unit

1 Choose Test Assignment on the Utility > Module Set screen. The Test Assignment
window is displayed.

Figure B-124 Test Assignment window

2 Select a test in the Test Name list box of the Test Assignment window.
3 Select the Assign check box.
4 Select the Mandatory check box if the reagent has to be on board all the time.
5 Select Na, K, Cl or Na, K.
o Na, K, Cl: This option allows sodium (Na+), potassium (K+) and chloride
(Cl-) ion testing on this ISE unit.
o Na, K: This option allows only sodium (Na) and potassium (K) testing on this
ISE unit.
6 Choose OK.

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Calculated Tests

Calculated Tests

This section explains how to program calculated tests and compensated tests.
To display this screen, choose Utility > Calc. Test.

Figure B-125 Calc. Test screen

Programming calculated tests

Calculated test results are not performed on the system but are derived by applying a
test formula to the results of clinical chemistry tests performed on the analyzer. Yet,
test formulas are not to be applied on control material.
If test data to be used in the calculation is unavailable, the program does not perform
the calculation. Calculated test results cannot be edited. Use the following procedures
to add, edit or delete a calculated test formula.

Incorrect results due to modifying a calculated test formula

Editing a calculated test formula will change the calculated test result displayed on the
CAUTION Data Review screen.
Check the new formula for the calculated test before using it.

a To program a calculated test and enter a calculated test formula

1 Choose Utility > Calc. Test.
2 Select an empty line from the Calculated Test list at the top of the screen.
3 Choose Edit to display the Calculated Test Formula window.

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Calculated Tests

Figure B-126 Calculated Test Formula window

4 Select the type of sample (Ser/Pl, Urine, CSF, Suprnt) for which the calculated test
formula is being created from the Sample Type list.
5 Type the unit of measure (up to 6 characters) in the Unit of Measure box.
6 Type a name for the calculated test as it should appear on the report in the Report
Name box.
7 Type the short name of the calculated test (up to 5 characters) in the Test box.
8 Use the Test list to select a test that is part of the formula. After highlighting the
test, choose Select to add the test to the formula. The formula appears to the right
of the Test text box, after the equal sign. Use the Calculator area in the window to
enter mathematical operators and numerals in the correct sequence along with
test names until the formula is complete.
9 Now, set the range parameters.

a To set range parameters

1 Choose the Range tab.

Figure B-127 Calculated Test Formula - Range tab

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Calculated Tests

2 Type the expected value ranges or the qualitative parameters in the Range area, if
needed. Select the Default Setting, if needed.
e For information about editing the expected values, see:
Expected values on page B-189

3 Choose OK to save the new formula and close the Calculated Test Formula
window. The new formula is shown in the Calculated Test list box at the top of the
Calculated Test screen.

The number of digits displayed to the right of the decimal in the calculated test result is
determined by the number of digits entered to the right of the decimal for the first Male
Expected Value field on the Range tab of the Calculated Test Formula window.

4 Choose Utility > Report Format.

5 Select the defined test in the Print Order area.
6 Type an unused line number into the Line field.
7 Choose Update and Save to save the changes.

a To edit a calculated test formula

1 Choose Utility > Calc. Test.
2 Select the calculated test formula to be edited from the Calculated Test list box at
the top of the screen.
3 Choose Edit to display the Calculated Test Formula window.
4 Use C in the Calculator area of the window to clear the entire formula or CE to
clear components of the formula one at a time from right to left.
5 Use the Test list to select the first test that is part of the formula. After highlighting
the test, choose Select to add the test to the formula. The formula appears to the
right of the Test text box, after the equal sign. Use the Calculator area in the
window to enter mathematical operators and numerals in the correct sequence
with test names until the formula is complete.
6 Choose the Range tab. Type the expected value ranges or the qualitative
parameters in the Range area, if needed. Change the Default settings, if needed.
7 Choose OK to save the formula programming and close the Calculated Test
Formula window. The revised formula appears in the Calculated Test list box at
the top of the Calculated Test screen.

a To delete a calculated test formula

1 Choose Utility Calc. Test.
2 In the Calculated Test list box, select the calculated test to be deleted.
3 Choose Delete to the right of the Calculated Test list box. A confirmation window
appears.
4 Choose Yes to delete the calculated test and close the window.

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Calculated Tests

Programming compensated tests

Clinical chemistry test results can be processed on the system and adjusted by
applying a compensated test formula. Use the following procedures to add, edit or
delete a compensated test formula.

a To enter a compensated test formula

1 Choose Utility > Calc. Test.
2 Select an empty line in the Compensated Test list box at the bottom of the screen.
3 Choose Edit to display the Compensated Test Formula window.

Figure B-128 Compensated Test Formula window

4 Select the test and sample type to be compensated from the Test Name/Sample
Type list box in the upper left corner of the window.
5 Use the Test list to select any test that is part of the formula. Choose Select after
selecting the test to add it to the formula, which is shown at the top of the window.
Use the Calculator area to enter mathematical operators and numerals in the
correct sequence with test names.
6 Choose OK to save the new formula and close the Compensated Test Formula
window. The new formula is shown in the Compensated Test list box at the
bottom of the Calculated Test screen.

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Calculated Tests

a To edit a compensated test formula

1 Choose Utility > Calc. Test.
2 Select the compensated test formula to be edited from the Compensated Test list.
3 Choose Edit to display the Compensated Test Formula window.
4 Choose C in the Calculator area of the window to clear the entire formula, or CE
to clear components of the formula, one at a time, from right to left. Use the Test
list to select any test that is part of the formula. Choose Select after selecting the
test to add it to the formula, which is shown at the top of the window. Use the
Calculator area to enter mathematical operators and numerals in the correct
sequence with test names.
5 Choose OK to save the formula programming and close the Compensated Test
Formula window. The revised formula appears in the Compensated Test list box at
the bottom of the Calculated Test screen.

a To delete a compensated test formula

1 Choose Utility > Calc. Test.
2 Select the compensated test formula to be deleted from the Compensated Test list.
3 Choose Delete. A confirmation window is displayed.
4 Choose Yes to delete the compensated test and close the window.

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Special Wash

Special Wash

The cobas c 311 analyzer is a random access system. Therefore, the reagent probe and
the reaction cells may cause carryover and thus interferences between tests, and the
sample probe may cause sample carryover.
To avoid carryover and cross-contamination between tests use the special wash
function. This function allows you to preset combinations of reagents or samples that
may cause carryover so that washing will be carried out between them when the
combination is encountered during analysis.
The following section explains how to set the carryover avoiding function.

Programming a reagent probe wash

The reagent probe dips into the reagents when aspirating. To evade a reagent
carryover, program a special wash cycle for the reagent probe.
e For more information refer to the package insert NaOHD/SMS/Multiclean and the
carryover list.

a To program a reagent probe wash

1 Choose Utility > Special Wash.

Figure B-129 Special Wash screen

2 Select an empty line in the Reagent Probe list to add a reagent probe wash. To edit
an existing reagent probe wash, select the corresponding line.
3 Choose Edit, on the right of the Reagent Probe list, to display the Edit Reagent
Probe Wash window.

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Special Wash

Figure B-130 Edit Reagent Probe Wash window

4 In the From Reagent area, select the test name for the causal reagent in the Test list
box. Select the appropriate reagent type (R1, R2, or R3) in the Reagent Type list
box.
5 In the To Reagent area, select the test name for the affected test in the Test list box.
Select the appropriate reagent type (R1, R2, or R3) in the Reagent Type list box.
6 Select the Detergent type (D1, D2, D3, or Water) from the Type list box for each
reagent probe selected.
o D1 = NaOH-D (application code 947)
o D2 = SMS (application code 948)
o D3 = not yet defined (application code 949)
7 Then type the wash solution volume (from 20 to 180 µL) in the Volume text box.
8 Choose OK to add the new special wash to the list on the Special Wash screen and
close the window.
9 Check the amount of the appropriate detergent cassette on the instrument on the
Reagent > Status screen.

a To delete a reagent probe wash

1 Choose Utility > Special Wash.
2 Select the line in the Reagent Probe list to be deleted.
3 Choose Delete located below the Reagent Probe area to delete the reagent probe
wash after confirmation.

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Special Wash

Programming a cell wash

To evade the carryover of traces of the test mixture of one test to the next test
measured in that same reaction cell, program a special wash cycle for the reaction cell.

a To program a cell wash

1 Choose Utility > Special Wash.
2 Select an empty line in the Cell list to add a cell wash. To edit an existing cell wash,
select the corresponding line.
3 Choose Edit located below the Cell area to display the Edit Cell Wash window.

Figure B-131 Edit Cell Wash window

4 Select a test from the Test list box that requires cell washing.
5 Select the R1 check box to activate a cell wash for this test.
6 If more than 180 µL detergent solution is needed, select the R2 check box as well.
7 Select the Detergent type (D1, D2, D3, or Water) from the Type list box.
o D1 = NaOH-D (application code 947)
o D2 = SMS (application code 948)
o D3 = not yet defined (application code 949)
8 Enter the detergent solution volume (from 20 to 180 µL) in the Volume text box.
9 Choose OK to save the settings, add the programming to the Cell list box and
close the window.
10 Check the amount of the appropriate detergent cassette on the instrument on the
Reagent > Status screen.

a To delete a cell wash

1 Choose Utility > Special Wash.
2 Select the test to be deleted from the Cell list.
3 Choose Delete located below the Cell list box to delete the cell wash after
confirmation.

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Special Wash

Programming a sample probe wash

The sample probe dips into the sample when it aspirates sample liquid. To evade a
carryover of sample liquid, program a special wash cycle for the sample probe.

a To program sample probe wash

1 Choose Utility > Special Wash.
2 Select an empty line in the Sample Probe list to add a sample probe wash. To edit
an existing sample probe wash, select the corresponding line.
3 Choose Edit located below the Sample Probe area to display the Edit Sample Probe
Wash window.

Figure B-132 Edit Sample Probe Wash window

4 Select a test from the Test list box.

The Whole Blood Detergent Type list box is only active when RWI2 (HbA1c test) has been
selected.

5 Select the detergent type from the Detergent type list box.
This solution is used for washing the sample probe.
o 1 (Multiclean)
o 2 (SMS)
o 1+2 (D1+D2)
o water
The detergent aspiration volume is 35 µL.
6 Choose OK to save the settings.
7 Check that the appropriate wash solution is placed on the instrument in the
correct position.

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Special Wash

A (1) Multiclean
B (2) SMS

Figure B-133 Sample probe cleaners

8 Check the amount of the appropriate detergent on the Reagent > Status screen.

a To delete a sample probe wash

1 Choose Utility > Special Wash.
2 Select the test to be deleted from the Sample Probe list.
3 Choose Delete located below the Sample Probe list to delete the sample probe
wash after confirmation.

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Report Format

Report Format

This section explains how to customize the report format of the patient report.
The patient report (Print (global button)> Workplace> Data Print) can be printed in
two formats: Monitor format or Report format. Only the Report format can be
customized.

Customizing patient report format

a To customize patient report format

1 Choose Utility > Report Format to display the Report Format screen.

Figure B-134 Report Format screen

Customizing the report format of the patient report consists of the following
steps:
o Choose the page layout.
e To choose the page layout on page B-214
o Define the title, the positions of all other items, and the print order.
e To define the title and the positions of all other items on page B-215
o Choose Save to save the changes.

a To choose the page layout

1 Select the number of reports per page (1 or 2) from the Report/Page list.
2 Type the page length in lines in the Page Length box.
o for US letter (8 ½" x 11") type 66
o for A4 (21cm x 29,7 cm) type 72
3 Select the number of pages per sample (1 or 2) from the Page/Sample list.
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Report Format

4 Select the Report Format check box to print patient reports in report format or
deselect it to print in monitor format.
If automatic printout is activated (Utility > System (Page 4/5) > Automatic
Printout, select Emergency Sample) the STAT patient report is printed in the
selected format (report format or monitor format).
If you print the patient report from the Data Print screen (Print (global button)>
Workplace> Data Print) you can select the format regardless of the setting on the
Print Format screen.

a To define the title and the positions of all other items

1 Type the title to be used for the report header (up to 3 lines of 40 characters each)
in the Title text boxes.
2 Assign a print line and column to each of the items of report information, as
appropriate.

Printout failures due to wrong assignment of print lines and columns

Take care of the maximum character length of the items, especially when assigning more
than one demographic item to a line. For example, if the arrived date is assigned to line 4,
column 47 and the arrived time is also assigned to line 4, it must be assigned to column 56
or higher since the character length for the arrived date is 8. If the second item is assigned
to a column that is used by the first item, one of the items is not printed or only partially
printed.
Check that all items are printed out correctly before using this report format.

a To alter the print order

Incomplete printout of results due to missing print order Line number

If there is no Line number defined, the result is not printed out or displayed in the Print
CAUTION View screen, although the test itself is measured. The setting of Line number corresponds
to the test order in the printout.
For each test, a Line number must be defined.

1 In the Print Order area, select the test from the list.
2 Type the line number on which the test is to print in the Line text box.

Overwritten items due to wrong assignment of print order lines

Do not assign the same line number to a test that is assigned to any demographic
information in step 2 from To define the title and the positions of all other items.

3 Choose Update to update the print order information.

4 Choose Save to save the changes.

To check the report setup, print a report example from Print (global button) > Utility >
Report Example.

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Report Format

Comparison of data monitor format and report format

Data Print report (monitor format)

Data Monitor 07/06/20 09:59

Ser/Pl N 001 ID 000448

07/06/18 ALTL GGTI2 CHO2A TP2 CA MG
10:34:03 6.2 29 3.16 71 6 1
Admin

Figure B-135 Data Print report (monitor format, barcode mode)

Data Print report (report format)

* HITACHI AUTOMATIC ANALYZER *

ID 000180 DATE 07/07/30 16:29:02

S.NO. N 001 OPERATOR ID admin
S.TYPE Ser/Pl Comment-001
AGE
SEX
DRAW DATE
DRAW TIME
PRE-DILUTED NO
TEST RATIO RESULT UNIT EXPECTED VALUE ALARM
ALTL 54.0 U/L ( -99999- 999999)
GGT liquid 46 U/L ( -99999- 999999)
CHO2A 2.40 mmol/L ( -99999- 999999)
SCRE2 111 umol/L ( -99999- 999999)
CREJ2 123 umol/L ( -99999- 999999)
TP2 66.0 g/L ( -99999- 999999)
CA 8.0 mg/dL ( -99999- 999999)
MG 2.1 mg/dL ( -99999- 999999)
GLUC2 5.1 mmol/L ( -99999- 999999)
Na 113 mmol/L ( -99999- 999999)
K 3.7 mmol/L ( -99999- 999999)
Cl 80 mmol/L ( -99999- 999999)
L 14
H 1
I 2

Table B-27 Data Print report (report format)

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Saving system parameters

Saving system parameters

Use the following procedure to make a backup of system parameters. This

information can be restored by using the Read Floppy Disk option in the Parameter
Read/Write window, if required.
e See Restoring system parameters on page B-219.

a To save system parameters on a floppy disk

1 Switch on the system and wait until it is in standby mode.
2 Insert a new, blank floppy disk (3.5", 1.44 MB, formatted, PC compatible) into
disk drive A.

You can format a floppy disk using the maintenance item (13) Floppy Disk Utility, if
required.

3 Choose Utility > Maintenance.

Figure B-136 Maintenance screen

4 Select Maintenance from the Maintenance Type list.

5 Select (14) Parameter Read/Write from the Maintenance Items list.
6 Choose Select to display the Parameter Read/Write window.
7 Select the Write Floppy Disk option and choose Execute to save parameters to
floppy disk after confirmation.

Do not eject the floppy disk when the access lamp of the floppy disk drive is lit.

8 When processing is complete, remove the floppy disk from the disk drive and set
aside for use later in this procedure.

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Saving system parameters

The following system parameters are stored:

No. Item Details

1 Application parameters
2 Calculation test parameters
3 Carryover evasion for reagent probe and reaction cell
programming
4 Carryover evasion for sample probe
programming
5 Report format
6 System parameters Page size, Date format, QC settings, Calibration
mask settings, Barcode settings, Sample reception
settings, Screen saver settings, Automatic printout,
Print dilution ratio, Test name order
7 Alarm setting parameters
8 Host communication
parameters
9 Comment settings
10 Host communication
exception settings
11 Maintenance Log
12 Barcode check digit
parameters
13 Pipe function setting
14 Key setting parameters
15 Profile settings
16 Power up pipe settings
17 Reagent level check
parameters
18 ISE calibration settings ISE-A or ISE-B
19 Sample disk setting STAT position number
20 Start Cell No. Incremental
21 Scale setting for each graph
22 Start condition settings
23 Mandatory setting for each
test
24 Test assignment of ISE “Na, K” or “Na, K, Cl”
25 Host test code settings
26 Download settings cobas link settings
Table B-28 System parameters, stored by Parameter Read/Write function

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Restoring system parameters

Restoring system parameters

Use the following procedure to restore system parameters from a backup floppy disk.

a To restore system parameters to the system

1 Choose Utility > Maintenance.
2 Select 1 Maintenance from the Maintenance Type list on the left of the screen.
3 Select (14) Parameter Read/Write from the Maintenance Items list on the right.
4 Choose Select to open the Parameter Read/Write window.
5 Insert the floppy disk into the disk drive.
6 Select the Read Floppy Disk option.
7 Choose Execute and confirm with Yes to start loading the data.

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Restoring system parameters

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 Maintenance C

12 Safety information for maintenance . . . . . . . . . . . . . . . . . . . . . C-3

13 General maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5
14 Maintenance of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . C-25
cobas c 311 analyzer 12 Safety information for maintenance
Table of contents

Safety information for maintenance

Make sure that you have read and understood the chapter General safety information. The
following safety messages in particular are relevant:
Warning messages:
o Electrical shock by electronic equipment on page A-8
o Infection by samples and associated materials on page A-8
o Infection and injury due to sharp objects on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9
o Infection by waste solution on page A-9
o Contamination of the environment by waste solution and solid waste on page A-9
Caution messages:
o Personal injury due to contact with moving parts on page A-10
Observe the system safety labels illustrated and described starting on page A-13.

Before performing any maintenance, read the following safety messages carefully. If
you ignore these safety messages, you may suffer serious or fatal injury.

Infection and injury due to contact with instrument mechanism

Contact with the sampling mechanism or other mechanisms may result in personal injury
WARNING and infection.
o Whenever possible, keep the top cover and the front cover of the analytical unit closed.
o When working with open top cover while the instrument is powered on (e.g., for
cleaning pipetter probes), always put the analyzer in Maintenance mode or in
Shutdown status first.
o Do not open the top cover while the analyzer is performing maintenance.
o Do not touch any parts of the instrument other than those specified.
o Observe all instructions given in this manual very carefully.

Fire and burns due to the use of alcohol

Alcohol is a flammable substance.
o Keep all sources of ignition (e.g. sparks, flames or heat) away from the analyzer when
conducting maintenance or checks using alcohol.
o When using alcohol on or around the instrument, use no more than 20 mL at a time.

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Table of contents

Incorrect results due to low level of incubator bath

If the water supply is insufficient, the incubator bath can not be filled up properly. An alarm
CAUTION will be issued.
o Check that the tap at the outlet of the water tank is open.
o Check that the external water supply is turned on and that the water pressure meets
requirements.
o When the cause is eliminated, perform maintenance item (4) Incubation Water
Exchange to refill the incubator bath.

e For information about water pressure, see Operating conditions on page A-69.

Malfunction due to spilled liquid

Any liquid spilled on the instrument may result in malfunction or damage of the analyzer.
o Do not place samples, reagents or any other liquid on the surface of the analyzer.
o When removing and replacing the reaction cells, be careful not spill water from the
incubator bath.
o If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be
sure to wear protective equipment.

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cobas c 311 analyzer 13 General maintenance
Table of contents

General maintenance

This chapter provides general information about maintenance of the cobas c 311
analyzer. Concepts, such as maintenance pipes, maintenance pipe functions and
maintenance types are described as well as instrument care. Lists of maintenance
items and checks are also provided.

In this chapter Chapter 13

Overview ..................................................................................................................... C-7
Definitions ............................................................................................................ C-7
Maintenance concept ........................................................................................... C-8
Maintenance items ..................................................................................................... C-8
Performing maintenance items ........................................................................... C-9
Maintenance pipes ................................................................................................... C-10
Defining and editing maintenance pipes .......................................................... C-11
Performing maintenance pipes .......................................................................... C-12
Deleting maintenance pipes ............................................................................... C-12
Using Maintenance pipe functions .................................................................... C-13
Power Up Pipe function ............................................................................... C-13
Start Up Pipe function ................................................................................. C-14
Sleep Pipe function ....................................................................................... C-14
Recommended maintenance pipes .................................................................... C-15
Power ON pipe ............................................................................................. C-16
Sleep pipe ...................................................................................................... C-16
Weekly pipe ................................................................................................... C-16
Maintenance types ................................................................................................... C-17
Defining and editing maintenance types .......................................................... C-17
Tracking maintenance ........................................................................................ C-19
Maintenance report .................................................................................................. C-20
List of maintenance items ........................................................................................ C-21
List of maintenance checks ...................................................................................... C-24

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Table of contents

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cobas c 311 analyzer 13 General maintenance
Overview

Overview

Personal injury or damage to the analyzer due to non-observance of safety

information
o Before performing maintenance tasks on any part of the instrument, read the safety
notes for the corresponding maintenance item in the chapter on page C-3.
o It is the responsibility of the operator to properly care for and maintain the system in
order to ensure consistent and accurate functioning. Modifying or omitting the
maintenance procedures may result in a loss of performance or system reliability.

The part Maintenance contains information about the following topics:

o General maintenance
This is the current chapter. It describes the general maintenance concept and
software functions, which support you in performing maintenance tasks.
o Specific maintenance actions
The maintenance actions are described in the following chapter Maintenance of
the analyzer on page C-25.
All of the software screens shown in this part are used as examples only. Your screens
may differ depending on your system setup.

Definitions

Maintenance item A single maintenance procedure, such as (2) Photometer Check.

e For a list of maintenance items see List of maintenance items on page C-21

System-controlled maintenance Maintenance items that are performed without operator interaction (such as Air
Purge).

Operator-controlled Maintenance items that require operator interaction (such as Cleaning Sample
maintenance Probe).

User-definable maintenance Users may define their own maintenance items for the laboratory. User-definable
maintenance items are always maintenance actions that have to be performed
manually.

Maintenance pipe A combination of sequential maintenance items programmed into a fully automated
procedure, which can be performed by the analyzer without operator intervention.

Maintenance pipe function A function that automatically starts a maintenance pipe at a particular time (e.g., at
power-up).

Maintenance type A set of maintenance items (system-controlled, operator-controlled and user-

definable) and maintenance pipes grouped according to certain functions (such as
daily or weekly maintenance).

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Maintenance items

Maintenance concept

Performing maintenance items Maintenance items can be performed manually on the Utility > Maintenance screen.
manually
Operator-controlled and user-definable maintenance items cannot be part of a
maintenance pipe. Thus they have to be performed manually.
e See Performing maintenance items on page C-9

Maintenance pipes—performing A maintenance pipe is a set of system-controlled maintenance items (batch set). You
maintenance items can use a maintenance pipe so that certain maintenance items occur in a certain
automatically sequence.
Before usage, maintenance pipes must be defined under Utility > System (Page 2/5) >
Pipe Setting. Up to 20 pipes can be defined and each pipe can have up to ten
maintenance items including parameters belonging to them.
Maintenance pipes can be executed in two different ways:
o Manually by the user
o Automatically by means of maintenance pipe functions at power up of the system
(Power Up Pipe function) or before start of analysis (Start Up Pipe function)
e For more information on maintenance pipes, see:
Maintenance pipes on page C-10

Maintenance types—scheduling Maintenance items and maintenance pipes can be grouped together in a maintenance
and tracking maintenance items type according to certain functions (such as daily or weekly maintenance).
Within a maintenance type you can assign maintenance intervals (Period) and
warning levels to each maintenance item and maintenance pipe. Thus, you can create
and customize a maintenance schedule for every periodic maintenance task.
If a maintenance item or a maintenance pipe has been scheduled, you can track its
status (date of last execution and warning level) on the Maintenance screen. The
status of maintenance types is also displayed on the System Overview screen.
Maintenance types are configured in Utility > System (Page 2/5) > Maintenance
Setting.
e For more information on defining and using maintenance types, see:
Defining and editing maintenance types on page C-17
Tracking maintenance on page C-19.

Maintenance report—recording The analyzer records the execution of maintenance items in the Maintenance Report.
maintenance
The Maintenance Report is requested through Print (global button) > Utility >
Maintenance Report.
e See Maintenance report on page C-20

Maintenance items

Maintenance items can be performed as a single item or grouped together to a

maintenance pipe.

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Maintenance items

Performing maintenance items

This section describes how to perform a single maintenance item.

e For information about the available maintenance items, see:
List of maintenance items on page C-21

a To execute a maintenance item

1 Choose Utility > Maintenance to display the Maintenance screen.

Figure C-1 Maintenance screen

2 Choose an entry from the Maintenance Type list.

o The entries Maintenance and Check are predefined. They include only
maintenance items, no pipes.
o A self-defined maintenance type can include both: Maintenance items and
maintenance pipes.
3 Select the maintenance item to be performed from the Maintenance Item list.
4 Choose Select.
5 Define any parameters required.
6 Choose Execute.
The maintenance item is performed. The date of the maintenance item is updated.

The date of execution will also be updated even if operation is interrupted due to an alarm,
etc. In this case, perform the relevant maintenance item again and terminate it normally.

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Maintenance pipes

Maintenance pipes

A maintenance pipe is a set of system-controlled maintenance items (batch set). Using

maintenance pipes saves time by allowing the system to perform a series of
maintenance items without operator intervention.
Be sure to note the relation between maintenance pipes and maintenance pipe
functions:

Maintenance pipes Before usage, maintenance pipes must be defined under Utility > System (Page 2/5) >
Pipe Setting. The name of a pipe is freely definable, e.g. Power On pipe.
Roche recommends using maintenance pipes for automating instrument care, but
there are no pre-defined pipes on the system by default.
e For more information, see:
Defining and editing maintenance pipes on page C-11
Recommended maintenance pipes on page C-15

Maintenance pipes can be executed manually by the user. Alternatively, they can be
executed automatically by means of maintenance pipe functions.

Maintenance pipe functions A maintenance pipe function triggers the system to start a maintenance pipe at one of
those three particular times (events):
o At power-up (Power Up Pipe function)
o Before start of analysis (Start Up Pipe function)
o Before entering sleep mode after the last maintenance item is completed (Sleep
Pipe function)
e Using Maintenance pipe functions on page C-13

Example The Power On pipe contains multiple maintenance items (Figure C-2). It can be
executed manually or be assigned e.g., to the Power Up Pipe function. In the latter
case, the pipe function will automatically start the maintenance pipe at power-up.

Maintenance pipe:

Power On pipe Manual execution

- (4) Incubation Water Exchange
Automatic execution:
- (5) Air Purge
- (7) Reagent Prime Power Up Pipe function
- (2) Photometer Check

Start Up Pipe function

Figure C-2 Example of maintenance pipes and maintenance pipe functions

Note that:
o Power On is used as a name for a maintenance pipe. (This name is freely definable.)
o Power Up Pipe is a fixed name of a maintenance pipe function.

The following sections describe how maintenance pipes are defined, executed, and
deleted.

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Maintenance pipes

Defining and editing maintenance pipes

Use the following procedure to program a series of maintenance items into a specific
maintenance pipe. Up to 20 maintenance pipes are settable and up to ten items can be
defined in each pipe. These items are performed one after the other. When a
maintenance item is performed as part of a pipe, an asterisk appears on the left side of
the date on the Maintenance Report.
e See Maintenance report on page C-20

a To edit a maintenance pipe or to define a new pipe

1 Choose Utility > System (Page 2/5) > Pipe Setting to display the Maintenance
Pipe Setting window.

Figure C-3 Maintenance Pipe Setting window

2 Choose an existing pipe in the Pipe Name list to edit the pipe or choose the first
blank line to define a new pipe.
3 Choose Edit to display the Edit Pipe window.

Figure C-4 Edit Pipe window

4 Type an unused name for the new pipe in the Pipe Name text box or edit the name
of the existing pipe if you want to change its name.

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Maintenance pipes

5 Add a maintenance item to the Pipe Item List by choosing the maintenance item
on the Maintenance Item List, then choose Add.
For automatic transition to sleep mode after completion of a maintenance pipe,
select the Sleep check box.
6 Choose Parameter to define the parameters such as the number of cycles to be
performed depending on the maintenance item highlighted.
e For more information about the different maintenance items, see:
List of maintenance items on page C-21.
e For more information about the parameters of the different maintenance items, refer
to the Online Help for that particular window.

7 Choose OK to save the settings and return to the Edit Pipe window.
8 Repeat steps 5 to 7 for all items that are to be included in the pipe.
9 Delete items from the pipe by choosing the appropriate item on the Pipe Item List,
then choose Remove.

Items must be listed in the sequence that they are to be performed by the system. If the
items are not in the desired order, choose the item to be moved to highlight it, then choose
the appropriate arrow to move the item up or down in the list.

10 Choose OK when the pipe settings are complete. The pipe then appears in the
Pipe Name list in the Maintenance Pipe Setting window and as an option on
Utility > System (Page 2/5) > Power Up Pipe.

Performing maintenance pipes

The pipe must have been defined as a maintenance type first (see Defining and editing
maintenance types on page C-17).

a To execute a maintenance pipe

1 Choose Utility > Maintenance to display the maintenance screen.
2 Follow the procedure to execute a maintenance item, see To execute a maintenance
item on page C-9.
The maintenance pipe is performed. The date of the maintenance pipe is updated.
If the pipe is defined as a Sleep pipe, the system will enter Sleep mode after the
pipe has been performed.

Deleting maintenance pipes

a To delete a maintenance pipe

1 Choose Utility > System page (2/5) > Pipe Setting.
2 In the Pipe Name list, select the name of the pipe to be deleted.
3 Choose Delete and confirm with Yes to delete the maintenance pipe.

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Maintenance pipes

Using Maintenance pipe functions

Maintenance pipes can be performed automatically by the system by means of

maintenance pipe functions. The system provides three maintenance pipe functions,
which are described in the following.

Power Up Pipe function

Use the Power Up Pipe function to select a pipe to be performed at power up or wake
up of the system. However, the wake-up time takes effect only if the system was put in
sleep mode before (and not put into Shutdown status).

a To activate a Power Up pipe

1 Choose Utility > System (Page 2/5) > Power Up Pipe.

Figure C-5 Power Up Pipe window

2 Select the pipe to be performed at power up from the drop-down list box for each
day of the week.
3 In case you want to set a wake-up time, do the following:
o Select the check box to the right of the weekday for which you want to set a
wake-up time. (If the check box is deselected, the specified maintenance pipe is
executed after power up.)
o Set the time in the two boxes to the right of the check box.
4 Choose OK.
The PC will be restarted and the analytical unit initialized 10 minutes before the
specified time. Thereafter the maintenance pipe will be performed.
During sleep mode the wake-up time is displayed in the Logon window.

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Maintenance pipes

Start Up Pipe function

The Start Up Pipe function is used to automatically perform a selected pipe before the
start of analysis.

a To activate a Start Up Pipe function

1 Choose Start (global button) or press the F2 key to open the Start Conditions
window.

Figure C-6 Start Conditions screen (barcode mode)

The Start Up Pipe Setting area displays the maintenance pipe currently selected as
Start Up pipe. If no maintenance pipe is selected, None is displayed.
2 Choose Change in the Start Up Pipe Setting area.
3 Select the desired start up pipe from the list box on the Pipe Function window.
4 Choose OK to accept the change.
5 Choose Start (global button) to perform the displayed pipe.
After completion of the start up pipe, analysis will be started automatically.

Once the start up pipe begins, the Start Up Pipe Setting changes back to None.

Sleep Pipe function

The Sleep Pipe function enables the system to enter in sleep mode after a pipe has
been performed. If the Sleep Pipe function is not activated (Sleep check box is not
selected), the system returns to Standby when a pipe is completed.
e For information about Sleep mode, see:
Analyzer shutdown and sleep mode on page B-71

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cobas c 311 analyzer 13 General maintenance
Maintenance pipes

a To activate the Sleep Pipe function

1 Choose Utility > System (Page 2/5) > Pipe Setting to display the Maintenance
Pipe Setting window.
2 Choose the pipe in the Pipe Name list to be performed as a sleep pipe.
3 Choose Edit to display the Edit Pipe window.

Figure C-7 Edit Pipe window

4 Select the Sleep check box to activate the Sleep Pipe function.
The system automatically enters Sleep mode after the pipe is completed.
e See Recommended maintenance pipes on page C-15

5 Choose OK to save the settings and return to the Maintenance Pipe setting
window.

Recommended maintenance pipes

A maintenance pipe is a set of system-controlled maintenance items. This section

shows the maintenance pipes that Roche recommends for a proper use of the
analyzer. The maintenance items must be programmed in the order listed here for the
pipe to be performed correctly.

Automating instrument care We recommend using the maintenance pipe functions to perform maintenance pipes
automatically. This ensures a maximum at instrument care without operator
intervention.
e For information about maintenance pipes and maintenance pipe functions, see:
Maintenance pipes on page C-10
Defining and editing maintenance pipes on page C-11
Using Maintenance pipe functions on page C-13

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13 General maintenance cobas c 311 analyzer
Maintenance pipes

Power ON pipe
We recommend performing this maintenance pipe by means of a maintenance pipe
function—either after initialization of the analyzer (Power Up Pipe function) or
before start of analysis (Start Up Pipe function).
Note that even though a maintenance pipe can be executed automatically some
maintenance items require visual checks by the operator.

Maintenance Item Page

(4) Incubation Water Exchange C-22
(5) Air Purge C-22
(7) Reagent Prime; select the REF option C-22
cobas link Essential Information Upload C-23
(a)
(2) Photometer Check C-21
Table C-1 Recommended maintenance pipe—Power ON
(a) It can take up to 30 minutes after an (4) Incubation Water Exchange for the incubator to reach the
correct temperature (37 ± 0.1°C). Therefore perform the Photometer Check in a separate pipe if your
Power On pipe does not include a cobas link Essential Information Upload.

e For more information, see:

Power Up Pipe function on page C-13
Start Up Pipe function on page C-14

Sleep pipe
By use of the Sleep Pipe function the analyzer will automatically turn to sleep mode
after the maintenance pipe is completed.

Maintenance Item Page

(10) ISE Wash C-23
Table C-2 Recommended maintenance pipe—Sleep

e For more information, see:

Analyzer shutdown and sleep mode on page B-71
Sleep Pipe function on page C-14

Weekly pipe
We recommend performing this maintenance pipe every week before shutdown or
start up.

Maintenance Item Page

(6) Wash Reaction Parts C-22
(3) Cell Blank Measurement C-21
Table C-3 Recommended maintenance pipe—Weekly

Before you shut down the analyzer, check the cell blank values in the Print View window.
The values will be lost after shutdown.

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cobas c 311 analyzer 13 General maintenance
Maintenance types

Maintenance types

Maintenance items and maintenance pipes can be grouped together into a

maintenance type according to certain functions (such as daily, weekly, or monthly
maintenance).
By using maintenance types you can create a maintenance schedule. A separate
maintenance interval can be assigned to each maintenance item and maintenance
pipe within a maintenance type.

Predefined maintenance types Two Maintenance types are predefined: Maintenance and Check.
o Maintenance: Contains all available maintenance items except check routines and
service routines.
o Check: Contains all check routines.

Due time For each maintenance item or maintenance pipe, the control term (due time) is
settable. A maintenance item or pipe which has passed its scheduled term will be
indicated in yellow or red (depending on criticality) on screen:
o Indication in yellow: At warning level
o Indication in red: Overdue

Defining and editing maintenance types

Use the following procedure to group a series of maintenance items into a specific
maintenance type.

a To edit a maintenance type or define a new type

1 Choose Utility > System (Page 2/5) > Maintenance Setting.

Figure C-8 Maintenance Parameter Setting window

2 If a new Maintenance Type is to be defined, select a free line from the Maintenance
Type list, choose Edit, and proceed with step 3.
If an existing Maintenance Type is to be edited, select the appropriate line from
the Maintenance Type list, choose edit, and proceed with step 4.
3 Enter a name for the Maintenance Type in the text box at the top of the window.
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13 General maintenance cobas c 311 analyzer
Maintenance types

Figure C-9 Edit Maintenance Type window

4 Select an item from the Maintenance Items list box.

This list includes both maintenance items and user-defined maintenance pipes.
5 If different parameter options are available, select the Maintenance Parameter
Setting check box to activate the Parameter button.
6 Choose Parameter to display the Maintenance Parameter window for the selected
maintenance item, if available. Use this window to define parameters for the
selected maintenance item.
e For more information about the different Maintenance Parameter windows, refer to
the Online Help for that particular window.

7 For maintenance tracking, enter the frequency period in the text box and select
the time period (Hours, Days, Months) from the Period list box.
8 Select a timer function from the Timer list box:
o Realtime: The actual time
o Power On: Cumulative power-on time of the analyzer (excluding sleep time)
o Operation: Cumulative operation time
Power On time and Operation time are both listed on the Maintenance Report
(Print > Utility > Maintenance Report).
e See Maintenance report on page C-20.

9 Enter the warning level (%) in the Warning level text box.
Example:
If you define a period of 10 hours in real time and a warning level of 90%, the
analyzer will remind you to perform the maintenance item after 9 hours.
10 By selecting the Comment check box you can add a comment during execution
that will be printed out on the Maintenance Report.
11 Choose Update to add the item to the Maintenance Items list.
12 Repeat steps 3 to 11 for all maintenance items for the maintenance type.
13 Choose OK to save the group and its settings.
14 Choose Close to close the Edit Maintenance Type window.

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Maintenance types

Tracking maintenance

If you have assigned a maintenance interval to a maintenance item or a maintenance

pipe within a maintenance type, the analyzer reminds you when a maintenance item
or pipe has to be performed.
Maintenance tracking is done on the Maintenance screen. The status of maintenance
types is also displayed on the System Overview screen.

a To display the maintenance status

1 Choose Utility > Maintenance to display the Maintenance screen.

Figure C-10 Maintenance screen

The following information is displayed:

o The date the maintenance item or pipe was last performed.
o The maintenance type is highlighted in yellow or red if any item or pipe for
this maintenance type exceeds its warning level or its maintenance interval.
o The date in the item list is highlighted in yellow if the maintenance item or
pipe exceeds its warning level.
o The date in the item list is highlighted in red if the maintenance item or pipe
exceeds its maintenance interval.
2 If you need more information about the maintenance status of a particular
maintenance type, select a maintenance type and then a maintenance item or pipe
from the Maintenance Item list.
3 Choose Monitor to view the status of the selected maintenance item or pipe.
e For more information about the Maintenance Monitor window, refer to the Online
Help for that particular window.

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13 General maintenance cobas c 311 analyzer
Maintenance report

Maintenance report

The analyzer records the execution of maintenance items in the Maintenance Report.
The Maintenance Report is requested through Print (global button) > Utility >
Maintenance Report. When a maintenance item is performed as a part of a pipe, an
asterisk appears on the left side of the date on the Maintenance Report.

Maintenance Report 07/06/20 14:27

POWER ON TIME 1847 HOURS

OPERATION 316 HOURS

MAINTENANCE TYPE: Maintenance Page 1

MODULE: Analyzer Unit
MAINTENANCE
DATE TIME OP.ID COMMENTS
Reset
07/06/20 09:53 Admin
07/06/20 09:27 Admin
07/06/19 16:37 Admin
… … …
Photometer Check
* 07/06/20 09:53 Admin
* 07/06/19 08:31 Admin
Cell Blank Measurement
07/06/19 15:57 Admin
Incubation Water Exchange
* 07/06/20 08:43 Admin
* 07/06/19 08:21 Admin
Air Purge
* 07/06/20 08:49 Admin
* 07/06/19 08:27 Admin
Wash Reaction Parts
Reagent Prime
* 07/06/20 08:51 Admin
* 07/06/19 08:29 Admin
Cell Detergent Prime
Incubator Bath Cleaning
* 07/06/19 08:58 Admin
ISE Wash
07/06/19 17:06 Admin
Sample Probe Wash
Flow Path Wash

Table C-4 Maintenance report

To print out a report for a certain maintenance item, choose Utility > Maintenance and
select the desired maintenance item. Then choose Print (global button).

e For more information about the Maintenance Report, refer to the Online Help for that
particular window.

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cobas c 311 analyzer 13 General maintenance
List of maintenance items

List of maintenance items

The following section lists all maintenance items and a brief description of their
function. The time period in brackets denotes the approximate system time of the
maintenance item in (min:sec).
(ISE): Denotes that a function applies to the ISE unit only.
(P): Denotes that a function applies to the photometric unit only. In the maintenance
windows, the abbreviation AU is used to refer to the photometric unit (P).
(P+ISE): Denotes that a function applies to both units.

Infection and injury due to contact with instrument mechanism

Contact with the sampling mechanism or other mechanisms may result in personal injury
WARNING and infection.
o Keep the top cover closed whenever performing one of the maintenance items or
checks listed below.
o Make sure that the analyzer is in Standby before executing a maintenance item or
check.

(1) Reset (P+ISE) (0:30): Mechanical parts are reset to their home positions.

(2) Photometer Check (P) (2:40): Photometer output is checked by measuring a water blank of cell no. 1.
Perform this maintenance item daily.
Check the photometer values on Print > Photometer Check. Measurement results
must be below 14000. If results are higher, check the light path; if necessary, replace
the photometer lamp, then perform a cell blank measurement.
Before performing this maintenance item, check that the incubator temperature is
within 37 ± 0.1°C (see System Overview screen on page B-36).
Depending on the ambient temperature it can take up to 30 minutes after switching
on the analyzer or after maintenance item (4) Incubation Water Exchange for the
incubator to reach the correct temperature.
e See To check the light intensity on page C-96.

(3) Cell Blank Measurement (P) (16:50): Water blanks of all cells are measured. If there is a difference greater than
0.1 absorbance units in the results for one cell compared to the cell No. 1, that cell
number is written to the Abnormal Cell List. To view this list choose Print (global
button) > View. Perform this maintenance item weekly.
e For information about the cell blank measurement, see:
To perform a cell blank measurement on page C-51
To print the cell blank measurement results on page C-51.

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13 General maintenance cobas c 311 analyzer
List of maintenance items

(4) Incubation Water Exchange (P) (5:30): Incubator bath water is exchanged and Hitergent (4.3 mL) is added.
Perform this maintenance item daily. Incubator bath is also referred to as reaction
bath.
After this maintenance item has been performed, check that the incubator
temperature is within 37 ± 0.1°C (see System Overview screen on page B-36) before
performing maintenance item (2) Photometer Check. Depending on the ambient
temperature it can take up to 30 minutes for the incubator to reach the correct
temperature.

(5) Air Purge (P) (1:45): Any air is purged which may have become trapped in the sample and
reagent syringes. Water as well as any air are discharged at the rinse stations. Perform
this maintenance item daily.
With top cover closed, visually check that water is dispensed from the sample probe
and/or the reagent probe in a straight flow.
After air purge (in Standby mode), visually check the syringes and the tubing system
for leakage and air bubbles.
e See To perform an air purge (sample syringe or reagent syringe) on page C-90.

(6) Wash Reaction Parts (P) (29:30): All cells and probes are washed. The sample probe is washed with
Multiclean from the 70 mL detergent bottle (approx. 300 µL). The reagent probe and
reaction cells are washed with detergent from a cobas c pack (NaOH-D, application
code 947, 26 mL).
Perform this maintenance item weekly. If you are running DAT assays, then perform
this item daily. For more information please refer to the package insert of the assay.
e See To wash the reaction parts on page C-51.

(7) Reagent Prime (ISE): Reagents are primed according to the option chosen (IS+REF or REF). Perform
this maintenance item daily.
Whenever you replace either the ISE IS or ISE Ref. bottle, a reagent prime and an ISE
calibration must be carried out to fill the flow path with the new liquid and to
calibrate the ISE unit.

Options System Description Reagent

time consumption
IS+REF 9:30 Both ISE IS and ISE Ref. are primed. ISE IS: 9230 µL
ISE Ref.: 1690 µL
REF 1:50 ISE Ref. is aspirated through the reference ISE IS: 0 µL
cartridge to prime the reference electrode. ISE Ref.: 3120 µL
Table C-5 Reagent prime options

e For the REF option, see: To prime the ISE Ref. tubing on page C-68
For the IS+REF option, see: To prime lines on page C-77.

(8) Cell Detergent Prime (P) (8:55): Reagent lines for Cell Wash Solution I and II are primed; reagent lines are
purged of air and cells are filled up and emptied by vacuum.
You must select which detergents need to be primed (Detergent 1, Detergent 2, or
both).
e See To perform a cell detergent prime on page C-70.

(9) Incubator Bath Cleaning (P): Performs transition to incubator bath cleaning mode: the photometer lamp is
switched off and the incubator bath water is automatically drained. Then the analyzer
will perform a complete system shutdown.
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cobas c 311 analyzer 13 General maintenance
List of maintenance items

Switch off the analyzer after the control unit has powered off. After cleaning, power
on the analyzer as usual; the incubator bath is refilled with some water. A yellow
alarm is issued, indicating that the level of incubation water is below the lower limit.
Perform maintenance item (4) Incubation Water Exchange to exchange the incubator
bath water and to add Hitergent (4.3 mL).
Perform this maintenance item monthly to clean the incubator bath and the drain
filter, and quarterly to clean the ultrasonic mixer.
e See To remove reaction cells and to clean the incubator bath on page C-63
To clean the surface of the ultrasonic mixer on page C-80.

(10) ISE Wash (P+ISE) (28:15): The sample probe and the flow path of the ISE unit are washed. The
sample probe is washed with Multiclean from the 70 mL detergent bottle. The ISE
flow path is washed with SysClean from position W1 on sample disk. The ISE
electrodes are conditioned with Activator from position W2.
Perform this maintenance item daily. This item can be performed in a sleep pipe.
e For more information, see:
Sleep pipe on page C-16
To wash ISE flow path, ISE electrodes and the sample probe on page C-43.

(11) Sample Probe Wash (P) (6:10 for 5 cycles): The sample probe is washed with Multiclean from the 70 mL
detergent bottle (approx. 300 µL). This item can be used in case of a clogged probe.
e See To wash the sample probe on page C-105.

(12) Flow Path Wash (P) (20:30): The flow path, the drain port and the drainage tube of concentrated waste
solution are cleaned with Cell wash II (detergent consumption: approximately
70 mL).
Perform this maintenance item monthly.
e See To wash the reaction system on page C-73.

(13) Floppy Disk Utility A floppy disk inserted into the floppy disk drive will be formatted after confirmation.

(14) Parameter Read/Write Parameter settings are read from or written to a floppy disk.
e See To save system parameters on a floppy disk on page B-217
See To restore system parameters to the system on page B-219.

(15) Test Count Write Test count is written to a floppy disk.

(16) QC Timer Reset (P): Resets the control interval timer.

For example, the control interval timer is set to 10 hours. When 5 hours are left, the
user can reset the timer to 10 hours.

cobas link Essential Information Important data such as calibrator and control data is uploaded and stored on the
Upload cobas link data station. The last 5 backups will be stored, the oldest backup will be
overwritten with the newest backup. Hence the last 5 backups are available to restore
to the analyzer if required.
It is recommended performing this maintenance item every day. This maintenance
item can only be performed in a maintenance pipe. Therefore it can only be selected
on the Edit pipe window under Utility > System > Pipe Setting > Edit.
e For more information, see:
Defining and editing maintenance pipes on page C-11
Recommended maintenance pipes on page C-15
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13 General maintenance cobas c 311 analyzer
List of maintenance checks

List of maintenance checks

The following section lists all maintenance checks and gives a brief description of
their function.

(1) Disk Check Files are checked on hard disk or floppy disk and a directory listing is printed out. If a
malfunction occurs, the system issues an alarm. The hard disk check can also be used
to determine the software version.

(2) ISE Check (ISE) (18:00 for 10 cycles): The electrode output of ISE cartridges (Cl, K, Na and REF
cartridges) is measured with ISE IS and a listing of EMF values is printed out.
Perform this check twice after replacing the ISE cartridges and ISE tubing. Wait
10 minutes between each check.
e See To perform an ISE Check and calibrate the ISE unit on page C-77.

(3) Mechanisms Check (P+ISE) (9:30 for 30 cycles): Performs a functional check of mechanical parts of the
entire sample line of the analyzer (according to the number of cycles).
If the check box With Photo Interrupter Check is selected, the system checks
automatically all relevant photocoupler sensors during this maintenance function.
Only the defective sensors are shown in the Print View window.
Choose Stop (global button) to end this maintenance check. Perform this check as
needed after replacing the sample or reagent probe and after replacing the nozzle tips
on the cell rinse nozzles.
e See To perform a Mechanisms Check on page C-112.

(4) Barcode Reader Check (P) The barcode on a sample tube or cobas c pack is scanned. After pressing Stop, the
data are printed out for verification.
To check the function of the barcode reader:
o Select Sample Barcode Reader or Reagent Barcode Reader.
o In the former case, place a barcoded tube onto the sample disk and start the
Barcode Reader Check.
In the latter case, start the Barcode Reader Check and scan a cobas c pack.
If the check box With Photo Interrupter Check is selected, the system checks
automatically all relevant photocoupler sensors during this maintenance function.
Only the defective sensors are shown in the Print View window.
The reading results are shown in the Print View window.

(5) Probe Check (P+ISE) Puts the analyzer in probe adjust mode. In this mode, a probe—selected in
the Probe Check window—can be moved to designated positions by means of the
S.Stop button. As this function must be performed with closed cover, it is not possible
to sight check the alignment of the probe.
Select Stop to stop the Probe Check.

(6) Cuvette Mixing (P+ISE) (5:05 for 10 cycles): Performs a functional check on the ultrasonic mixer.
The reagent probe pipettes deionized water into the corresponding cuvette. Then the
cuvette is moved to the mixing position and ultra sonic mixing will be executed.
Perform this check after the quarterly cleaning of the ultrasonic mixer.
e See To check the intensity of the ultrasonic output on page C-81.

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cobas c 311 analyzer 14 Maintenance of the analyzer
Table of contents

Maintenance of the analyzer

This chapter describes the maintenance actions required for correct and efficient
running of the cobas c 311 analyzer. The maintenance of both the ISE unit and the
photometric unit is discussed. The schedule of required periodic maintenance actions
(daily, weekly, monthly…) is provided as well as maintenance actions that are
performed as needed.

In this chapter Chapter 14

Maintenance schedules ............................................................................................ C-27
Overview of maintenance schedules ................................................................. C-28
Overview of daily maintenance schedules ................................................... C-28
Overview of maintenance schedules—weekly and longer intervals .......... C-29
Scheduling periodic maintenance tasks ...................................................... C-30
Brief description of maintenance schedules ..................................................... C-30
Daily maintenance—at power on or start up ............................................. C-31
Daily manual maintenance .......................................................................... C-32
Weekly maintenance ..................................................................................... C-33
Monthly maintenance .................................................................................. C-34
Every two months maintenance .................................................................. C-35
Quarterly maintenance ................................................................................ C-35
Every six months maintenance .................................................................... C-36
As needed maintenance ................................................................................ C-37
Periodic replacement of parts .................................................................................. C-39
Daily maintenance .................................................................................................... C-40
M1: Washing ISE flow path and sample probe ................................................. C-40
M2: Cleaning pipetter probes and ISE sipper ................................................... C-44
M3: Cleaning cell rinse nozzles .......................................................................... C-47
M4: Cleaning the ISE drain port ....................................................................... C-49
Weekly maintenance ................................................................................................ C-50
M5: Washing the reaction parts ......................................................................... C-50
M6: Cleaning the cell covers .............................................................................. C-53
M7: Cleaning the rinse stations ......................................................................... C-55
M8: Checking and cleaning the water tank ....................................................... C-58

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14 Maintenance of the analyzer cobas c 311 analyzer
Table of contents

Monthly maintenance .............................................................................................. C-62

M9: Replacing reaction cells and cleaning incubator bath ............................... C-62
M10: Cleaning the ISE Ref. aspiration filter ..................................................... C-66
M11: Cleaning the detergent aspiration filters ................................................. C-68
M12: Cleaning the radiator filter ....................................................................... C-72
M13: Washing flow path of concentrated waste solution ................................ C-73
Every two months maintenance .............................................................................. C-74
M14: Replacing ISE measuring cartridges (Cl, K, Na) ..................................... C-74
Quarterly maintenance ............................................................................................ C-79
M15: Cleaning the ultrasonic mixer .................................................................. C-79
M16: Replacing the ISE pinch valve tubing ...................................................... C-82
M17: Replacing the ISE sipper tubing ............................................................... C-84
M18: Replacing the syringe seals ....................................................................... C-85
Every six months maintenance ................................................................................ C-93
M19: Cleaning the inlet water filter ................................................................... C-93
M20: Cleaning the cooling fan ........................................................................... C-95
M21: Replacing the photometer lamp ............................................................... C-96
M22: Replacing the ISE reference cartridge .................................................... C-101
As needed maintenance ......................................................................................... C-104
M23: Replacing sample and reagent probes—elimination of clogging ......... C-104
M24: Replacing nozzle tips on cell rinse nozzles ............................................ C-113
M25: Draining the vacuum tank ..................................................................... C-115

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Maintenance schedules

Maintenance schedules

This section provides you with an overview of the maintenance actions that are
required for proper instrument care. The information is divided into a tabular
overview and a brief description of the maintenance actions.
The information is sorted according to the frequency with which the actions must be
performed.

Personal injury or damage to the analyzer

This section Maintenance schedules comprises only a brief description for operators who
are familiar with performing maintenance actions on the cobas c 311 analyzer.
o Observe the safety precautions given in the detailed description of the maintenance
actions (see also on page C-3).
o For the first several times, follow the detailed description of the maintenance actions as
listed below.

e For a detailed description of performing maintenance actions, see:

Daily maintenance on page C-40
Weekly maintenance on page C-50
Monthly maintenance on page C-62
Every two months maintenance on page C-74
Quarterly maintenance on page C-79
Every six months maintenance on page C-93
As needed maintenance on page C-104

NOTICE Precautions for continuous operation

The intervals for maintenance and checkup recommended in this document are based on
an average analyzer running time of 5 hours a day.
If the instrument is used continuously (without shutdown) for 24 hours or longer—for
example, for STAT measurements at night—reset all maintenance intervals to meet the
actual running hours of your analyzer and use customized maintenance types to schedule
your maintenance tasks.

e See Maintenance types on page C-17.

NOTICE Precaution for operation after longtime-shutdown

If the analyzer has been shut down for a week or more, check its performance before
starting up operation again. For details, consult your local service representative.

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14 Maintenance of the analyzer cobas c 311 analyzer
Maintenance schedules

Overview of maintenance schedules

The recommended intervals for maintenance and checkup are based on an average
analyzer running time of 5 hours a day. For proper instrument care, maintenance and
checkup must be conducted in accordance with the list and with the actual running
time of the analyzer.

Infection and injury due to contact with instrument mechanism

Contact with the sampling mechanism or other mechanisms may result in personal injury
WARNING and infection.
o Whenever possible, keep the top cover of the analytical unit closed.
o Make sure that the analyzer is in Standby before executing a maintenance item or
check.
o If a check or maintenance action requires open covers (e.g., cleaning pipetter probes),
always make sure that the analyzer is in Standby before using the maintenance switch
to put the analyzer into Maintenance mode (or before shutting down the instrument).

Overview of daily maintenance schedules

Action Related Mode(b) Operator System Page

(a)
Action time (min) time (min)
approx. approx.
Daily—at (4) Incubation Water Exchange SB 6 C-22
starting-up (5) Air Purge SB 2 C-22
(Power ON pipe)
(7) Reagent Prime; select the REF option SB 2 C-22
cobas link Essential Information Upload SB C-23
(2) Photometer Check SB 3 C-21
Daily manual M2: Cleaning pipetter probes and ISE sipper M23 MA/PO 3 (2)(d) C-44
maintenance(c) M3: Cleaning cell rinse nozzles M24 MA/PO 3 (2) C-47
M4: Cleaning the ISE drain port SB/MA/PO 3 C-49
Check that the drain tube of the vacuum tank is empty SB/MA/PO 1 C-115
Empty the waste solution container SB/MA/PO 3 C-32
Clean up spilled liquid from the instrument surfaces MA/PO 1 C-32
(including cell covers)
Daily—items that M1: Washing ISE flow path and sample probe, SB 1 29 C-40
can be includes (10) ISE Wash C-23
performed in a Only if running DAT assays: SB 1 58 C-50
Sleep Pipe (10) ISE Wash; plus (6) Wash Reaction Parts
Table C-6 Overview of daily maintenance schedules
(a) Related maintenance actions: It may be reasonable to combine these items, if a monthly or higher-order maintenance interval falls due.
(b) We recommend using the instrument status in bold, see Table C-8 on page C-29.
(c) Make sure to check the daily items before starting up the analyzer Starting the analyzer on page B-30.
(d) A system time in brackets refers to the time for changing the instrument status before and after performing this maintenance item.

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Maintenance schedules

Overview of maintenance schedules—weekly and longer intervals

Action Related Mode(b) Operator System Page

(a)
Action time (min) time (min)
approx. approx.
Weekly M5: Washing the reaction parts(c) SB 1 47 C-50
M6: Cleaning the cell covers M9 MA/PO 3 (2) C-53
M7: Cleaning the rinse stations MA/PO 5 (2) C-55
M8: Checking and cleaning the water tank PO 10 C-58
Monthly M9: Replacing reaction cells and cleaning incubator M15 PO(d) 10 47 C-62
bath
M10: Cleaning the ISE Ref. aspiration filter MA/PO 5 (2) C-66
M11: Cleaning the detergent aspiration filters SB/MA/PO 5 C-68
M12: Cleaning the radiator filter SB/MA/PO 5 C-72
M13: Washing flow path of concentrated waste SB 1 21 C-73
solution
Every 2 months M14: Replacing ISE measuring cartridges (Cl, K, Na) M16-17 MA/PO 10 56 C-74
+M22
Quarterly M15: Cleaning the ultrasonic mixer M9 PO(d) 10 5 C-79
M16: Replacing the ISE pinch valve tubing MA/PO 6 46 C-82
M17: Replacing the ISE sipper tubing MA/PO 6 46 C-84
M18: Replacing the syringe seals MA/PO 15 10 C-85
Every 6 months M19: Cleaning the inlet water filter PO 5 C-93
M20: Cleaning the cooling fan PO 5 C-95
M21: Replacing the photometer lamp PO 10 17 C-96
M22: Replacing the ISE reference cartridge MA/PO 5 48 C-101
As needed M23: Replacing sample and reagent probes— PO(e) 7 12 C-104
elimination of clogging
M24: Replacing nozzle tips on cell rinse nozzles MA/PO 6 10 C-113
M25: Draining the vacuum tank SB/MA/PO 5 C-115
Table C-7 Overview of maintenance schedules—weekly and longer intervals
(a) Related maintenance actions: It may be reasonable to combine these items, if a monthly or higher-order maintenance interval falls due.
(b) We recommend using the instrument status in bold, see Table C-8 on page C-29.
(c) Perform daily if running DAT (drugs of abuse testing) assays. For more information please refer to the package insert of the assay.
(d) Start the maintenance item (9) Incubator Bath Cleaning from Standby. Then power off the analyzer as described.
(e) Start the maintenance item (11) Sample Probe Wash from Standby. Then power off the analyzer as described.

Instrument statuses (modes) PO Power OFF (shutdown)

SB Standby mode
MA Maintenance mode (using the maintenance switch)
Table C-8 Abbreviations for instrument statuses (modes)

e For more information, see:

Instrument statuses on page B-32
Power ON pipe on page C-16
Sleep pipe on page C-16.

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14 Maintenance of the analyzer cobas c 311 analyzer
Maintenance schedules

Scheduling periodic maintenance tasks

Create a maintenance schedule that is customized to your laboratory’s individual
requirements. We recommend letting the analyzer software remind the operator of all
periodic maintenance tasks. You can do this by configuring maintenance types (in
Utility > System (Page 2/5) > Maintenance Setting). Within a maintenance type, you
can assign maintenance intervals (Period) and warning levels to each maintenance
item and maintenance pipe.
e For more information on scheduling maintenance tasks, see
Maintenance types—scheduling and tracking maintenance items on page C-8
Maintenance types on page C-17.

Brief description of maintenance schedules

The following section provides you with a brief description of the maintenance items
and maintenance actions that are required for proper instrument care.

Personal injury or damage to the analyzer

This section comprises only a brief description for operators who are familiar with
performing maintenance actions on the cobas c 311 analyzer.
o Observe the safety precautions given in the detailed description of the maintenance
actions (see also on page C-3).
o For the first several times, follow the detailed description of the maintenance actions
(see the following cross-references).

e For detailed description of performing maintenance actions, see:

Daily maintenance on page C-40
Weekly maintenance on page C-50
Monthly maintenance on page C-62
Every two months maintenance on page C-74
Quarterly maintenance on page C-79
Every six months maintenance on page C-93
As needed maintenance on page C-104

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cobas c 311 analyzer 14 Maintenance of the analyzer
Maintenance schedules

Daily maintenance—at power on or start up

The following table provides you with an overview of the maintenance actions that
must be performed on a daily basis.

Checks before start-up of the There are various conditions that need to be checked before an analyzer start-up.
analyzer Therefore it is important to inspect the analyzer before starting up.
e For more information, see Start-up inspection on page B-30.

Maintenance items that can be Below is a list of maintenance items that are suitable for use in a maintenance pipe. In
performed in a Power Up pipe connection with the Power Up Pipe function this maintenance pipe will be executed
automatically at power on of the analyzer.
e For information about maintenance pipe functions, see:
Using Maintenance pipe functions on page C-13
e For information about power on and sleep pipes, see:
Recommended maintenance pipes on page C-15

Item Description Page

(4) Incubation Water Power ON pipe C-22
Exchange Check that the temperature of the incubator is within 37 ± 0.1°C on the System Overview screen
before starting analysis.
(5) Air Purge Power ON pipe; select the All option C-22
With top cover closed, visually check that water is being discharged at all rinse stations as well as C-111
through sample probe and reagent probe.
After air purge (in Standby mode), visually check the syringes and the tubing system for leakage C-91
and air bubbles.
(7) Reagent Prime Power ON pipe; select the REF option C-22
cobas link Essential Power ON pipe C-23
Information Upload
(2) Photometer Check(a) Power ON pipe C-21
Check the photometer values on the Print View window. C-96
Table C-9 Instrument care - daily (power on)
(a) It can take up to 30 minutes after an (4) Incubation Water Exchange for the incubator to reach the correct temperature (37 ± 0.1°C). Therefore
perform the Photometer Check in a separate pipe if your Power On pipe does not include a cobas link Essential Information Upload.

Visual checks at power ON

Note that even though a maintenance pipe can be executed automatically some of the
maintenance items listed above require visual checks with top cover closed.

e See also: Start-up inspection on page B-30.

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14 Maintenance of the analyzer cobas c 311 analyzer
Maintenance schedules

Daily manual maintenance

The following table provides you with an overview of the maintenance actions that
must be performed on a daily basis.

Action Description Page

M1: Washing ISE flow path o (10) ISE Wash: The inside of the sample probe is cleaned as well as the ISE flow path and C-40
and sample probe the electrodes; after cleaning, the ISE electrodes are reconditioned with Activator.
Sample probe detergent, position 1 (on the left of the shield pipe): Multiclean (cycles: 5)
Pos. W1: SysClean (cycles: 15)
Pos. W2: Activator (cycles: 15)
o Only if running DAT assays: Perform M5: Washing the reaction parts additionally. For more
information please refer to the package insert of the assay.
Can be included in a sleep pipe.
M2: Cleaning pipetter o Put the analyzer in Maintenance mode or Shutdown status. C-44
probes and ISE sipper o Clean the probes, the ISE sipper nozzle, and the outside of the shield pipe with gauze pads
moistened with 70% ethanol.
Upon detection of abnormal sample aspiration caused by a clot, the sample probe is washed
automatically by the analyzer.
M3: Cleaning cell rinse o Put the analyzer in Maintenance mode or Shutdown status. C-47
nozzles o Clean the nozzle tips of the cell rinse unit with gauze pads moistened with deionized water.
M4: Cleaning the ISE drain o Use deionized water to rinse crystals from the outlet of the drain port at the rear of the C-49
port analyzer.
Check the drain tube of the o Check that the drain tube of the vacuum tank is empty. C-115
vacuum tank
Empty the waste solution o Empty the waste container for highly concentrated waste at the rear of the analyzer.
container Wear protective gloves when performing this procedure. Contents of the ISE drain port are
potentially biohazardous.
Clean up instrument o Put the analyzer in Maintenance mode or Shutdown status.
surfaces o Remove samples. Clean up spills immediately using a paper towel moistened with 70%
ethanol.
o Check the cell covers for contamination. If necessary, clean the cell covers using a gauze
pad moistened with 70% ethanol.
Spills on the instrument surface could be potentially biohazardous and/or cause damage to the
instrument.
Table C-10 Instrument care - daily (before shutdown or sleep)

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Maintenance schedules

Weekly maintenance
The following table provides you with an overview of the maintenance actions that
must be performed on a weekly basis.

Action Description Page

M5: Washing the reaction Perform this maintenance action daily, if DAT assays are performed on the analyzer. For more C-50
parts information please refer to the package insert of the assay.
o (6) Wash Reaction Parts: Cleans sample probe with Multiclean (300 µL) and reagent probe
and reaction cells with NaOH-D from a cobas c pack (application code 947, 26 mL).
o (3) Cell Blank Measurement: Perform maintenance item (3) Cell Blank Measurement to
obtain new photometric reference.
o Check the cell blank values in the Print View window before you shut down the analyzer.
Can be included in a weekly pipe.
M6: Cleaning the cell covers o Put the analyzer in Maintenance mode or Shutdown status. C-53
o Wipe front and rear faces of cell covers using a gauze pad moistened with 70% ethanol.
o Wipe openings of cell covers using a cotton swab.
M7: Cleaning the rinse o Put the analyzer in Maintenance mode or Shutdown status. C-55
stations for the sample o Clean rinse stations using cotton swabs moistened with 2% Hitergent solution. Inject 2%
probe and the reagent probe Hitergent solution and deionized water into the rinse stations.
o Clean the drying cylinders of both rinse stations with cotton swabs moistened with 70%
ethanol.
M8: Checking and cleaning o Shut down the analyzer. C-58
the water tank o Turn off the external water supply.
o Disconnect the water tank and remove the float assembly.
o Visually check that the water is clear.
o If it is clear, empty the water tank and rinse it with deionized water three times.
o If not, clean with 0.5% sodium hypochlorite solution using a brush. Rinse tank thoroughly
with deionized water three times.
o Wipe float assembly with gauze pads moistened with deionized water.
o Replace tank filled at least 1/3 full with deionized water, then reconnect.
Table C-11 Instrument care - weekly

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14 Maintenance of the analyzer cobas c 311 analyzer
Maintenance schedules

Monthly maintenance
The following table provides you with an overview of the maintenance actions that
must be performed on a monthly basis.

Action Description Page

M9: Replacing reaction cells Replacing the reaction cells: C-62
and cleaning incubator bath o Put the analyzer in (9) Incubator Bath Cleaning mode. The water is drained from the
incubator bath and the control unit is powered off.
o Power off the analytical unit.
o Remove the cell rinse unit, the sipper covers and the reaction cells.
o Mount new reaction cells or continue with cleaning the incubator bath.
Cleaning the incubator bath: C-63
o Make sure that the analyzer is still powered off.
o Clean incubator bath and photometer windows using lint-free gauze pads.
o Clean drain filter of incubator bath with tap water and rinse with deionized water or 2%
Hitergent solution.
o Put the reaction cells back in place.
o Return cell rinse unit, sipper cover and cell covers.
o Switch on the analyzer. A yellow alarm will indicate low level of incubator water.
o Perform maintenance item (4) Incubation Water Exchange to exchange incubator bath
water.
o Perform maintenance items (6) Wash Reaction Parts and (3) Cell Blank Measurement.
M10: Cleaning the ISE Ref. Clean aspiration filter each time you replace the ISE Ref. bottle but at least once a month. C-66
aspiration filter o Put the analyzer in Maintenance mode or Shutdown status.
o Remove the filter from the tube end.
o Clean the filter with tap water and rinse it with deionized water.
o Reset remaining volume if the reagent bottle is replaced.
o Perform maintenance item (7) Reagent Prime with the REF option selected.
M11: Cleaning the detergent Clean aspiration filters, which are attached to the tube ends, each time you replace a detergent C-68
aspiration filters bottle (Cell wash I and Cell wash II) but at least once a month.
o Remove the filter from the tube end.
o Wash the filter with tap water and rinse it with deionized water.
o Reset remaining volume if a detergent bottle is replaced.
o Perform maintenance item (8) Cell Detergent Prime and select the appropriate detergent.
M12: Cleaning the radiator o Clean the radiator filter and radiator fins with a vacuum cleaner. C-72
filter
M13: Washing flow path of o (12) Flow Path Wash: Cleans flow path of concentrated waste solution with acidic C-73
concentrated waste solution detergent (Cell wash II, approx. 70 mL).
Table C-12 Instrument care - monthly

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Maintenance schedules

Every two months maintenance

The following table provides you with an overview of the maintenance actions that
must be performed at least every two months.

Action Description Page

M14: Replacing ISE Replace cartridges (Cl, K, Na) every two months or after 9000 tests, whichever occurs first. C-74
measuring cartridges (Cl, K, o Put the analyzer in Maintenance mode or Shutdown status.
Na) o Replace ISE measuring cartridges.
o Perform maintenance item (7) Reagent Prime (IS+REF).
o Perform maintenance check (2) ISE Check (two times with 10 minutes in between,
10 cycles each) to condition the electrodes. Then, calibrate the ISE unit.
Table C-13 Instrument care - every two months

Quarterly maintenance
The following table provides you with an overview of the maintenance actions that
must be performed on a quarterly basis.

Action Description Page

M15: Cleaning the Cleaning: Include this maintenance in the monthly cleaning of the incubator bath. C-79
ultrasonic mixer o Put the analyzer in (9) Incubator Bath Cleaning mode. The water is drained from the
incubator bath and the control unit is powered off (shutdown).
o Power off the analytical unit.
o Remove the cell cover and the segment of reaction cells near the ultrasonic mixer.
o Wipe surface of ultrasonic mixer with a cotton swab moistened with 2% Hitergent
solution.
o Wipe off the detergent with a cotton swab moistened with deionized water.
o Put the reaction cells and the cell cover back in place. In case you are re-using used
reaction cells, be sure to put them back in their previous positions.
o Switch on the analyzer. A yellow alarm will indicate low level of incubator water.
o Perform maintenance item (4) Incubation Water Exchange to exchange the incubator bath
water.
o Perform maintenance check (6) Cuvette Mixing (10 cycles).
M16: Replacing the ISE Exchange: If possible, replace sipper tubing and pinch valve tubing at the same time. C-82
pinch valve tubing o Put the analyzer in Maintenance mode or Shutdown status.
and o Exchange the ISE pinch valve tubing.
M17: Replacing the ISE o Exchange the ISE sipper tubing. C-84
sipper tubing o Perform maintenance check (2) ISE Check (two times with 10 minutes in between,
10 cycles each) to condition the electrodes. Then, calibrate the ISE unit.
M18: Replacing the syringe Exchange: Replace the syringe seals if they have been used for more than three months or after C-85
seals 112,500 tests for the sample syringe or reagent syringe (or 56,250 tests for the sipper syringe,
respectively), whichever occurs first.
o Put the analyzer in Maintenance mode or Shutdown status.
o Remove the syringe.
o Replace the syringe seals and reattach the syringe.
o When replacing the reagent syringe seals or sample syringe seals, perform maintenance
item (5) Air Purge.
o When replacing the ISE sipper syringe seals, perform maintenance item (7) Reagent Prime
(IS+REF).
o After the reagent prime or air purge (in Standby mode), check all connections for leakages
and the syringe barrel for air bubbles.
Table C-14 Instrument care - quarterly

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14 Maintenance of the analyzer cobas c 311 analyzer
Maintenance schedules

Every six months maintenance

The following table provides you with an overview of the maintenance actions that
must be performed at least every six months.

Action Description Page

M19: Cleaning the inlet o Shut down the analyzer. C-93
water filter o Turn off the external water supply.
o Place a 500 mL beaker beneath the inlet water manifold.
o Disconnect the inlet water hose.
o Clean the filter thoroughly with deionized water, then reinstall the filter.
o Turn on the external water supply.
M20: Cleaning the cooling o Shut down the analyzer. C-95
fan o Vacuum dust from the cooling fan at the rear of the analyzer.
M21: Replacing the Exchange: Replace the photometer lamp if it has been used for more than six months or C-96
photometer lamp 750 hours(a), or if a photometer check value exceeds 14000.
o Power off the analyzer. Wait 30 minutes for the photometer lamp to cool down.
o Replace the photometer lamp.
o Wait 30 min for the photometer lamp to stabilize, then perform maintenance item (3) Cell
Blank Measurement (necessary to compensate for a change in light intensity).
M22: Replacing the ISE Exchange: If possible, combine this replacement with the two-monthly replacement of the C-101
reference cartridge measuring cartridges (Cl, K, Na).
o Put the analyzer in Maintenance mode or Shutdown status.
o Replace ISE reference cartridge.
o Perform maintenance item (7) Reagent Prime (REF).
o Perform maintenance check (2) ISE Check (two times with 10 minutes in between,
10 cycles each) to condition the electrodes. Then, calibrate the ISE unit.
Table C-15 Instrument care - every six months
(a) This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the analyzer by looking at the printed Maintenance
Report (Print > Utility > Maintenance Report).

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Maintenance schedules

As needed maintenance
The following table provides you with an overview of the maintenance actions that
must be performed as needed.

Action Cause Measure Page

Waste solution Despite emptying the container at the beginning or Empty the waste container at the rear of the
container for highly at the end of the day, it can fill up in the course of a analyzer.
concentrated waste working session. Wear protective gloves when performing this
An alarm is issued when the waste container gets procedure. The contents of the waste container are
too full. potentially biohazardous.
M10: Cleaning the When replacing ISE reference solution bottle. o Put the analyzer in Maintenance mode or C-66
ISE Ref. aspiration An alarm is issued on the System Overview screen Shutdown status.
filter when the ISE reference solution bottle is empty o Remove the filter from the tube end.
(Reagent Preparing > Reagent Load/Unload List). o Wash the filter with tap water and rinse it
with deionized water.
o Reset remaining volume.
o Perform maintenance item (7) Reagent
Prime with the REF option selected.
M11: Cleaning the When replacing cell detergents (Cell wash I or II) o Remove the filter from the tube end. C-68
detergent aspiration behind the front doors. o Wash the filter with tap water and rinse it
filters An alarm is issued on the System Overview screen with deionized water.
when a detergent bottle gets empty (Reagent Load/ o Reset remaining volume.
Unload List in the Work Flow Guide) o Perform maintenance item (8) Cell
Detergent Prime.
Rinsing the sample When the sample probe gets clogged, this is o Perform maintenance item (11) Sample
probe – elimination automatically detected by the probe. Sampling Probe Wash.
of clogging stops and an alarm is issued. o If the clogging is not eliminated, clean the C-104
sample probe manually.
M23: Replacing Sample aspiration error occurs frequently. o Shut down the analyzer. C-104
sample and reagent An alarm for clogging of the sample probe occurs o Remove the probe, clean it, and eliminate
probes—elimination and is not reset after cleaning (maintenance item clogging.
of clogging (11) Sample Probe Wash). o If a probe is bent or damaged, replace it.
o Perform maintenance item (5) Air Purge.
A probe is bent or otherwise damaged.
With top cover closed, visually check that
Upon detection of abnormal sample aspiration water is dispensed from the tip of the probe
caused by a clot, the sample probe is washed in a straight flow.
automatically by the analyzer. o Perform maintenance check
(3) Mechanisms Check (30 cycles).
M21: Replacing the The lamp has been used for more than o Perform maintenance item (2) Photometer C-96
photometer lamp 750 hours(a). Check.
A photometer check value exceeds 14000. o If any of the current data exceeds 14000,
check the light path for contamination or
scratches. Check that cell no. 1 is at least
half filled with water.
o Shut down the analyzer. Wait 30 minutes
for the photometer lamp to cool down.
o Replace the photometer lamp.
o Wait 30 minutes for the photometer lamp
to stabilize.
o Perform maintenance item (3) Cell Blank
Measurement.
Table C-16 Instrument care - as needed (Sheet 1 of 2)
(a) This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the analyzer by looking at the printed Maintenance
Report (Print > Utility > Maintenance Report).

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14 Maintenance of the analyzer cobas c 311 analyzer
Maintenance schedules

Action Cause Measure Page

M14: Replacing ISE The cartridge has been used for 2 months. o Put the analyzer in Maintenance mode or C-74
measuring cartridges The test count has reached 9000 tests. Shutdown status.
(Cl, K, Na) o Replace ISE measuring cartridges.
The slope value of the cartridge falls outside the
o Perform maintenance item (7) Reagent
normal range. See Figure C-32: ISE data alarms
Prime (IS+REF).
and corresponding slope values (EMF values) on
o Perform maintenance check (2) ISE Check
page C-74.
(two times with 10 minutes in between,
10 cycles each).
o Calibrate the ISE unit.
M18: Replacing the The syringe seals have been used for more than o Put the analyzer in Maintenance mode or C-85
syringe seals three months. Shutdown status.
The test count has reached 112,500 tests for the o Remove the syringe.
sample syringe or reagent syringe (or 56,250 tests o Replace the syringe seals and reattach the
for the sipper syringe, respectively). syringe.
o When replacing the reagent syringe seals or
sample syringe seals, perform maintenance
item (5) Air Purge.
o When replacing the ISE sipper syringe seals,
perform maintenance item (7) Reagent
Prime (IS+REF).
o Afterwards (in Standby mode), check all
connections for leakages and the syringe
barrel for air bubbles.

M24: Replacing The cell rinse nozzle tips are worn so that water o Put the analyzer in Maintenance mode or C-113
nozzle tips on cell remains in the reaction cell. Shutdown status.
rinse nozzles The replacement cycle is typically one to two years o Remove the cell rinse unit.
depending on conditions of use. o Replace nozzle tip.
o Attach the cell rinse unit.
o Check the alignment of the new nozzle tip.
o Perform a (3) Mechanisms Check
(30 cycles).
M25: Draining the Alarm (Liquid in Vacuum Tank) is issued. o Remove the cap holding the drain tube of C-115
vacuum tank the vacuum tank.
o Drain the waste solution into a beaker.
Table C-16 Instrument care - as needed (Sheet 2 of 2)
(a) This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the analyzer by looking at the printed Maintenance
Report (Print > Utility > Maintenance Report).

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cobas c 311 analyzer 14 Maintenance of the analyzer
Periodic replacement of parts

Periodic replacement of parts

Some parts require periodic replacement for preventive maintenance. Replace these
parts regularly and in accordance with your workload and the recommendations
given in this document. For purchase, inform your local service representative of the
part number.

ISE unit Item As required 2 months 3 months 6 months Page

ISE measuring cartridges x(a) C-74
(Cl, K, Na)
ISE pinch valve tubing x C-82
ISE sipper tubing x C-84
(b)
Syringe seals x C-85
ISE reference cartridge x C-101
Table C-17 Periodic replacement of parts for the ISE unit
(a) Replace the ISE measuring cartridges after two months or after measuring 9000 samples.
(b) Replace the sipper syringe seals after three months or after measuring 56,250 samples.

Photometric unit Item As required Monthly 3 months 6 months Page

Reaction cells x C-62
(a)
Syringe seals x C-85
(a)
Photometer lamp x C-96
Sample and reagent probe x C-104
Nozzle Tips of cell rinse unit x C-113
Table C-18 Periodic replacement of parts for the photometric unit
(a) Replace the sample and reagent syringe seals after three months or after measuring 112,500 samples.
(b) Replace the lamp if the photometer check value exceeds 14000 or when used for more than 750 hours.
This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the analyzer
by looking at the printed Maintenance Report (Print > Utility > Maintenance Report).

Spare parts
For proper instrument care use only original spare parts provided by Roche.
o The necessary spare parts are listed in the description of the corresponding
maintenance action.
o To order spare parts, please contact your Roche representative.

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14 Maintenance of the analyzer cobas c 311 analyzer
Daily maintenance

Daily maintenance

In this section you will find all the maintenance actions that must be performed every
day.

Before performing any maintenance actions, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page C-3
o Infection by waste solution on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

e This section discusses the following maintenance actions:

M1: Washing ISE flow path and sample probe on page C-40
M2: Cleaning pipetter probes and ISE sipper on page C-44
M3: Cleaning cell rinse nozzles on page C-47
M4: Cleaning the ISE drain port on page C-49

Contamination of flow paths or pipetter probes may cause incorrect measurement

results or clogging. Therefore, make sure to regularly perform the stated maintenance
procedures.

The maintenance items listed in the Power ON pipe and the Sleep Pipe must also be
performed every day.

e For more information, see:

Power ON pipe on page C-16
Sleep pipe on page C-16.

M1: Washing ISE flow path and sample probe

At the end of analysis each day, the ISE flow path and the sample probe have to be
washed. This is a combined maintenance procedure for both ISE and photometric
unit.
The inside of the sample probe is cleaned as well as the ISE flow path and the
electrodes; after cleaning, the electrodes are reconditioned with Activator.
This maintenance action comprises the following procedures:
1. To set the number of washing cycles
2. To check the detergents and ISE reagents for the amounts remaining
3. To wash ISE flow path, ISE electrodes and the sample probe (maintenance item
(10) ISE Wash)

Operator time: approximately 1 minute

System time: approximately 29 minutes

Materials required m Detergent and ISE reagent consumption:

e See Table C-19 on page C-42

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cobas c 311 analyzer 14 Maintenance of the analyzer
Daily maintenance

o Roche recommends performing the cleaning of the ISE flow path and the sample
probe and the conditioning of the electrodes within a sleep pipe. Then you do not have
to perform this maintenance step manually. Make sure that there are sufficient
quantities of reagent remaining.
o Even if you are not using the ISE unit, you must nevertheless perform a wash after daily
operation. You can use either ISE Wash or Sample Probe Wash to do this.

e See Sleep Pipe function on page C-14.

a To set the number of washing cycles

1 Set the number of cycles for detergent pipetting:
o Choose Utility > System.
o Enter the number of cycles for both Photometric and ISE in the Wash
Sampling area (recommended are 5 cycles for Photometric and 15 for ISE).
2 Choose OK to save the settings.

a To check the detergents and ISE reagents for the amounts remaining
1 Make sure that the analyzer is in Standby.
2 Choose System Overview > Reagent Overview button

A Sample cleaner 1 (Multiclean) B ISE reagents

Figure C-11 Reagent overview screen

3 Check the detergents and ISE reagents for the amounts remaining in the Reagent
Overview screen.
o If inadequate, replace detergent or reagent bottles.
e See To replace ISE IS or ISE Dil. on page B-43.
e See To replace ISE reference solution (ISE Ref.) on page B-44.
e See To replace a sample probe detergent bottle on page B-109.
o Set detergents onto sample disk. Pipette suitable amounts of SysClean and
Activator into sample cups as shown in Figure C-12.

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14 Maintenance of the analyzer cobas c 311 analyzer
Daily maintenance

Detergents and reagents Name Position Consumption

Sample cleaner 1 Multiclean approx. 230 µL
(a)
ISE cleaning solution SysClean W1 approx. 300 µL
(a)
ISE Activator Activator W2 approx. 300 µL
Internal standard ISE IS approx. 22 mL
Diluent ISE Dil. approx. 6 mL
Reference solution ISE Ref. approx. 2 mL
Table C-19 Detergent and ISE reagent consumption (for 5 photometric washing cycles
and 15 ISE washing cycles)
(a) On the sample disk

A
F

A Sample cleaner 1 (Multiclean) D Internal standard ISE IS

B W1: ISE cleaning solution SysClean E Diluent ISE Dil.
C W2: Activator F Reference solution ISE Ref.

Figure C-12 Positions of required reagents

If the amount of detergent in the cups is insufficient or if no cup is present, an alarm is

issued (ISE Cleaning Solution Short).

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Daily maintenance

a To wash ISE flow path, ISE electrodes and the sample probe
1 Make sure that the analyzer is in Standby.
2 Check the detergents and ISE reagents for the amounts remaining in the Reagent
Overview screen.
e See To check the detergents and ISE reagents for the amounts remaining on page C-41.

3 Place the cups on their positions W1 and W2.

4 Choose Utility > Maintenance.

Figure C-13 Maintenance screen

5 Select Maintenance (1) from the Maintenance Type list on the left.
6 Select (10) ISE Wash from the Maintenance Items list on the right.
7 Choose Select to open the ISE Wash window.
8 Choose Execute.
The inside of the sample probe is cleaned as well as the ISE flow path and the
electrodes.
Make sure that you calibrate the ISE unit before you resume routine analysis.
e For details on how to calibrate the ISE unit, see:
Requesting and cancelling calibrations manually on page B-123.

If ISE wash is interrupted for some reason, perform maintenance item (6) Wash Reaction
Parts. Afterwards perform maintenance item (7) Reagent Prime and select IS+REF.

e For information on how to perform these maintenance items, see:

M5: Washing the reaction parts on page C-50
To prime lines on page C-77.

9 If DAT (drugs of abuse testing) assays are measured on the analyzer, perform M5:
Washing the reaction parts on page C-50 additionally.

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14 Maintenance of the analyzer cobas c 311 analyzer
Daily maintenance

M2: Cleaning pipetter probes and ISE sipper

At the end of analysis each day, clean the outside of the pipetter probes (sample probe,
reagent probe) and the ISE sipper nozzle to remove residual solution and
precipitation. This is a combined maintenance procedure for both ISE and
photometric unit.
Replace pipetter probes when they are bent or otherwise damaged.
When sample aspiration error occurs frequently or if an alarm for clogging of the
sample probe occurs and is not reset after cleaning (maintenance item (11) Sample
Probe Wash, page C-105), you must remove the sample probe and eliminate clogging.
e For instructions on how to eliminate clogging, see:
M23: Replacing sample and reagent probes—elimination of clogging on page C-104

Operator time: approximately 3 minutes

System time: approximately 2 minutes

Materials required m Lint-free gauze pads

m Paper towels
m 70% ethanol

Before performing this maintenance action, observe the following safety

precautions:
o Infection and injury due to sharp objects on page A-9
o Fire and burns due to the use of alcohol on page C-3

a To clean the outside of pipetter probes and ISE sipper

1 Put the analyzer in Maintenance mode or Shutdown status.
In both statuses, the pipetter probes can be easily moved by hand to accessible
positions.
e For more information, see:
To put the analyzer in Maintenance mode (yellow bar in status line) on page B-33
To shut down the analyzer on page B-72

2 Unlock and open the top cover of the analyzer.

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Figure C-14 Cleaning the sample probe and the shield pipe

Use a new lint-free gauze pad for each probe to prevent cross-contamination. Be careful
not to soak the gauze pad so that liquid does not drip down into the reaction cells.

3 Wipe (from top to bottom) the outside of the sample probe with gauze pads
moistened with 70% ethanol.
4 Lift up the shield pipe and moving the sample probe by hand to a position above
the sample disk.
5 Also wipe the inside of the shield pipe with a gauze pad moistened with 70%
ethanol.

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A Screw on the right side of the sipper cover

B Two screws on the left side of the sipper cover

Figure C-15 Cleaning the ISE sipper nozzle and the reagent probe

6 Remove the sipper cover:

o Loosen and remove the screw on the right side (A).
o Loosen the two screws on the left side (B).
7 Wipe (from top to bottom) the outside of the sipper nozzle with a gauze pad
moistened with 70% ethanol.
8 Attach the sipper nozzle cover.
9 Wipe (from top to bottom) the outside of the reagent probe with gauze pads
moistened with 70% ethanol.
10 Close the top cover of the analyzer and lock it (or: continue with the next
maintenance action using Maintenance mode).
11 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
12 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
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M3: Cleaning cell rinse nozzles

At the end of analysis each day, clean the cell rinse nozzles. Regular cleaning prevents
contamination, crystal formation, and clogging.
Replace the nozzle tip if it has worn down. The replacement cycle is typically 1 to
2 years, depending on the conditions of use.
e For instructions on how to replace nozzle tip, see:
M24: Replacing nozzle tips on cell rinse nozzles on page C-113

Operator time: approximately 3 minutes

System time: approximately 2 minutes

Materials required m Lint-free gauze pads

m Cleaning wire (stainless steel) of 0.5 mm diameter
m Deionized water

a To clean the cell rinse nozzles

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

Figure C-16 Dismounting the cell rinse unit and cleaning the nozzles

3 Loosen the retaining screw of the cell rinse unit and lift off the entire unit.
4 Moisten a lint-free gauze pad with deionized water and gently wipe all tips of the
cell rinse nozzles in a downward motion.
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Daily maintenance

5 If a nozzle is clogged, insert the probe cleaning wire (stainless steel wire, 0.5 mm
diameter) into the tip of the nozzle and eliminate the clogging.
6 Attach the cell rinse unit.
7 Close the top cover of the analyzer and lock it (or: continue with the next
maintenance action using Maintenance mode).
8 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
9 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.

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M4: Cleaning the ISE drain port

At the end of analysis each day, clean the outlet of the ISE drain port. Regularly
perform this maintenance to prevent the accumulation of crystals and clogging of the
drain port.
Operator time: approximately 3 minutes

Materials required m Lint-free gauze pads

m Deionized water

Before performing this maintenance action, observe the following safety

precautions:
o Infection by waste solution on page A-9
o Contamination of the environment by waste solution and solid waste on page A-9

a To clean the outlet of the ISE drain port

Figure C-17 Cleaning the ISE drain port

1 The analyzer can be either in Standby, Maintenance mode, or Shutdown status.

2 Use deionized water to rinse crystals from the outlet of the ISE drain port at the
rear of the analyzer.
3 Wipe up spilled water.

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Weekly maintenance

Weekly maintenance

In this section you will find all the maintenance actions that must be performed at
least once a week.

Before performing any maintenance actions, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page C-3
o Infection by waste solution on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

e This section discusses the following maintenance actions:

M5: Washing the reaction parts on page C-50
M6: Cleaning the cell covers on page C-53
M7: Cleaning the rinse stations on page C-55
M8: Checking and cleaning the water tank on page C-58

The maintenance items listed in the weekly pipe must also be performed.

e For more information, see:

Weekly pipe on page C-16.

M5: Washing the reaction parts

Contamination of the reaction cells or the waste solution flow path will result in
incorrect measurement results. Wash the reagent probe and reaction cells at least once
a week. Perform this maintenance action daily, if DAT (drugs of abuse testing) assays
are performed on the analyzer. For more information please refer to the package
insert of the assay.
After washing the reaction system, perform a cell blank measurement to check the
condition of the reaction cells.
Operator time: approximately 1 minute
System time: approximately 47 minutes (30 minutes for (6) Wash Reaction Parts and
17 minutes for (3) Cell Blank Measurement)
This maintenance action comprises the following procedures:
1. To wash the reaction parts (maintenance item (6) Wash Reaction Parts)
2. To perform a cell blank measurement (maintenance item (3) Cell Blank
Measurement)
3. To print the cell blank measurement results
4. To identify reaction cells that require cleaning or replacement

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a To wash the reaction parts

1 Make sure that the analyzer is in Standby.
2 Check how much detergent remains for the sample probe, reagent probe and
reaction cells. If the quantity is insufficient, add new detergent.
o For sample cleaner 1: Choose System Overview > Reagent Overview in the
Inventory area.
o For reagent probe and reaction cell detergent: Choose System Overview >
Reagent Overview in the Reagent area.

Detergent Reagent Consumption

Sample probe detergent Multiclean approximately 300 µL
Reagent probe and reaction NaOH-D cassette approximately 26 mL
cell detergent (application code 947)
Table C-20 Detergent consumption for washing reaction parts

o If it is necessary to replace a detergent bottle or to add a new cobas c pack, see:

e To load a cobas c pack on page B-45
e To replace a sample probe detergent bottle on page B-109

3 Choose Utility > Maintenance.

4 Choose Maintenance (1) on the Maintenance Types list on the left.
5 Choose (6) Wash Reaction Parts on the Maintenance Items list on the right.
6 Choose Select to open the Wash Reaction Parts window.
7 Choose Execute.
The procedure is finished when the analyzer returns to Standby.
Now, proceed with the cell blank measurement.

a To perform a cell blank measurement

1 Choose Utility > Maintenance.
2 Choose (3) Cell Blank Measurement on the Maintenance Items list on the right.
3 Choose Select to open the Cell Blank Measurement window.
4 Choose Execute.
Now, print the results of the cell blank measurement to check if cleaning or
replacement of cells is required.

a To print the cell blank measurement results

1 Choose Print (global button).
2 Choose the Utility tab and select Cell Blank Measurement from the print list on
the left.
3 Choose Print.
Whenever the cell blank value of a reaction cell falls outside of the normal range,
the number of that reaction cell is printed on the Abnormal Cell List.
Normal cell blank values are: < 14000 for all no. 1 cells and a difference between
the no. 1 cell and the cells 2-66 of less than ± 1000 (± 0.1 E).
After printing the Abnormal Cell List, continue with Step 4 of the following
procedure.
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Cell Blank Measurement 07/06/20 14:26

--------------------------------------- ABNORMAL CELL LIST ---------------------------------------

07/06/19 14:43 --------------------------------- WAVELENGTH (nm) ---------------------------------

CELL NO. 340 376 415 450 480 505 546 570 600 660 700 800

001 12953 11414 11152 10756 10519 10333 10057 9918 9705 9442 9283 8938
002 12972 11444 11170 10771 10534 10350 10072 9932 9717 9459 9299 8952
003 12973 11446 11172 10776 10538 10354 10075 9934 9719 9459 9297 8949
004 12976 11444 11172 10775 10538 10354 10075 9933 9716 9455 9296 8949
005 12991 11468 11191 10793 10555 10369 10091 9949 9734 9475 9314 8963
006 12985 11460 11184 10790 10553 10367 10088 9947 9730 9469 9309 8959
007 12975 11450 11177 10780 10544 10359 10080 9938 9722 9462 9304 8954
008 12949 11413 11148 10752 10513 10327 10049 9909 9695 9436 9276 8930
009 12970 11451 11175 10779 10540 10356 10079 9937 9723 9465 9307 8956
010 12964 11433 11165 10771 10532 10346 10068 9927 9712 9449 9290 8940
… … … … … … … … … … … … …
065 12950 11423 11157 10763 10526 10341 10063 9922 9709 9446 9288 8943
066 12965 11440 11169 10775 10538 10354 10077 9937 9723 9462 9303 8956

Table C-21 Example of a Cell Blank Measurements report with Abnormal Cell List

a To identify reaction cells that require cleaning or replacement

1 Perform the maintenance item (6) Wash Reaction Parts.
e See To wash the reaction parts on page C-51.

2 Perform the maintenance item (3) Cell Blank Measurement.

e See To perform a cell blank measurement on page C-51.

3 After the cell blank measurement, print the measurement results to identify
contaminated or defective reaction cells.
e See To print the cell blank measurement results on page C-51.

4 Check for reaction cells whose numbers are listed in the Abnormal Cell List.
Replace reaction cells that are scratched or cracked.
e See To remove reaction cells and to clean the incubator bath on page C-63.

5 After cleaning or replacing reaction cells, perform a cell wash, then make sure that
you perform a cell blank measurement.

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M6: Cleaning the cell covers

The cell covers serve to prevent contamination by reagent and reaction solutions. If
reagent adheres to the front or rear face of a cell cover, the analytical accuracy may
decrease.
At the end of analysis each day, check the cell covers for contamination. Clean the cell
covers at least once a week.
Operator time: approximately 3 minutes
System time: approximately 2 minutes

Materials required m Cotton swabs

m Lint-free gauze pads
m 70% ethanol
m Deionized water

Before performing this maintenance action, observe the following safety

precautions:
o Fire and burns due to the use of alcohol on page C-3

a To clean the cell covers

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

Figure C-18 Removing cell covers

3 Remove the cell covers.

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6/7

A U-cover

Figure C-19 Cleaning cell covers and U-cover

4 Wipe the front and rear faces of the cell covers using a gauze pad moistened with
70% ethanol.
5 Wipe the openings of cell covers using a cotton swab moistened with 70% ethanol.
6 Pinch the sides of the U-cover (A) and pull it off the cell cover.
7 Wash the U-cover with deionized water. In case dust and dirt do not come off,
wipe the U-cover using a cotton swab moistened with 70% ethanol.
In case you are also performing monthly maintenance, we recommend continuing
with the following action:
e See M9: Replacing reaction cells and cleaning incubator bath on page C-62.

8 Attach the dried U-cover and put the cell covers back in place.
9 Close the top cover of the analyzer and lock it (or: continue with the next
maintenance action using Maintenance mode).
10 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
11 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.

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M7: Cleaning the rinse stations

Clean the rinse stations of the sample probe and the reagent probe at least once a
week to prevent bacterial growth or precipitation that may clog the rinse stations.
Operator time: approximately 5 minutes
System time: approximately 2 minutes

Materials required m 50 mL syringe with tubing

m Cotton swabs
m 2% Hitergent solution
m 70% ethanol
m Deionized water

Before performing this maintenance action, observe the following safety

precautions:
o Fire and burns due to the use of alcohol on page C-3
o Malfunction due to spilled liquid on page C-4

a To clean the rinse stations

1 Put the analyzer in Maintenance mode or Shutdown status.
In both statuses, the pipetter probes can be easily moved by hand to accessible
positions.
e For more information, see:
Maintenance mode on page B-33
To shut down the analyzer on page B-72

2 Unlock and open the top cover of the analyzer.

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5
3 6

B C

A Rinse station C Drying cylinder

B Tip water aspiration position

Figure C-20 Cleaning the rinse station of sample probe

3 Using a cotton swab moistened with 2% Hitergent solution, clean the inside of the
sample probe rinse station.

Be careful not to splash liquid (water or Hitergent) into the drying cylinder.

4 Inject about 10 mL of 2% Hitergent solution into the sample probe rinse station.
5 Inject about 100 mL of deionized water into the rinse station to rinse it.
6 Wipe the drying cylinder (used for vacuum suction in the sample probe rinse
stations) with a cotton swab moistened with 70% ethanol.

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5
3 6

A B

A Rinse station B Drying cylinder

Figure C-21 Cleaning the rinse station of reagent probe

7 Clean the rinse station and the drying cylinder for the reagent probe in the same
way as you clean the sample probe rinse station.
8 Close the top cover of the analyzer and lock it.
9 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
10 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.

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Weekly maintenance

M8: Checking and cleaning the water tank

Contamination inside the tank will result in contamination of the entire flow path
and adversely affect all measurements. Check the water tank at least once a week and
clean the tank if necessary.
Operator time: approximately 10 minutes
System time: approximately 2 minutes

Materials required m Lint-free gauze pads

m Paper towels
m Waste solution receptacle
m 0.5% sodium hypochlorite solution
m Deionized water

a To disconnect the water tank

1 Shut down the analyzer.

Electrical shock by electronic equipment

Cleaning of the water tank without turning off the power of the instrument allows the
WARNING deionized water supply unit to supply water during cleaning. Water supplied from the
deionized water supply unit may damage the instrument and lead to malfunction. There is
also a danger of electrical shock since there are some parts at high voltage inside the
analytical unit.
o Make sure that the analyzer is switched off before you continue.
o Do not reach into the analyzer without switching off power first.

2 Turn off the external water supply.

3 Open the left front door.

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A Closed tap

Figure C-22 Disconnecting the joint of the water tank

4 Close the tap at the outlet of the water tank.

5 Place a waste solution receptacle (or paper towels) under the hose unit to absorb
spilled water.
6 Separate the joint that connects the water tank and the water hose.

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Figure C-23 Removing the float assembly

7 Remove the float assembly from the tank while pulling out the tank and place the
float on a paper towel.
8 Visually check that the water is clear. If not, perform thorough cleaning.
e See: To thoroughly clean the water tank on page C-61

9 If the water is clear, empty the water from the tank and rinse it with deionized
water three times.
10 Fill the tank at least 1/3 full of deionized water.
11 Reconnect the water tank.
e See: To reconnect the water tank on page C-61

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a To thoroughly clean the water tank

1 Empty the water from the tank and rinse it thoroughly with 0.5% sodium
hypochlorite solution. For thorough cleaning use a brush to clean the interior
surface. Then wash with tap water to eliminate the sodium hypochlorite solution.
2 Rinse the tank thoroughly with deionized water three times.
3 Fill the tank at least 1/3 full of deionized water.
4 Reconnect the water tank.
e See: To reconnect the water tank on page C-61

a To reconnect the water tank

1 Wipe the float assembly with gauze pads moistened with deionized water.
2 Return the float assembly and place the tank back in its original position.

NOTICE Malfunction due to spilled liquid

If the joints of the water tank are not connected properly, water may leak and cause
damage to circuit boards.
Ensure that all joints are connected properly.

3 Reconnect the water hose to the water tank and open the tap (Figure C-22).
4 Close left front door.
5 Turn on the external water supply.
6 Ensure the top cover is locked, before you switch on the analyzer again.

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Monthly maintenance

Monthly maintenance

In this section you will find all the maintenance actions that must be performed at
least once a month.

Before performing any maintenance actions, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page C-3
o Infection by waste solution on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

e This section discusses the following maintenance actions:

M9: Replacing reaction cells and cleaning incubator bath on page C-62
M10: Cleaning the ISE Ref. aspiration filter on page 66
M11: Cleaning the detergent aspiration filters on page C-68
M12: Cleaning the radiator filter on page C-72
M13: Washing flow path of concentrated waste solution on page C-73

M9: Replacing reaction cells and cleaning incubator bath

Replace the reaction cells once a month because they gradually deteriorate over a
prolonged period of use. We recommend cleaning the incubator bath and incubator
bath filter at the same time.
Contamination inside the incubator bath (reaction bath) or on the photometric
window will reduce the reproducibility of measurement results. Clean the incubator
bath and photometric window at least once a month.

This maintenance action comprises the following procedures:

1. To remove reaction cells and to clean the incubator bath
2. To clean the drain filter of the incubator bath
3. To reinstall reaction parts and to terminate the incubator bath cleaning mode
Operator time: approximately 10 minutes
System time: approximately 47 minutes (30 minutes for (6) Wash Reaction Parts and
17 minutes for (3) Cell Blank Measurement)

Materials required m Hitergent cassette (surfactant for the incubator, consumption 4.3 mL)
m Lint-free gauze pads
m Deionized water or 2% Hitergent solution

Before performing this maintenance action, observe the following safety

precautions:
o Malfunction due to spilled liquid on page C-4

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a To remove reaction cells and to clean the incubator bath

1 Switch on the analyzer (if it was in Shutdown status).
2 Choose System Overview > Reagent Overview screen.
3 Check the remaining amount of Hitergent. If insufficient, add a new cobas c pack.
4 Put the analyzer in incubator bath cleaning mode:
o Choose Utility > Maintenance.
o Select Maintenance (1) from the Maintenance Type list on the left.
o Select (9) Incubator Bath Cleaning from the Maintenance Items list on the
right.
o Choose Select to open the Incubator Bath Cleaning window.
o Choose Execute. The water is drained from the incubator bath and the control
unit is powered off (shutdown).
5 After the computer power supply has powered off, switch off power for the
analytical unit.

Do not open the top cover until the analyzer is in shutdown.

6 Unlock and open the top cover of the analyzer.

Figure C-24 Removing cell rinse unit and segments of reaction cells

7 Remove the cell rinse unit, the sipper cover and the cell covers.
8 Remove each segment of the reaction cells from the reaction disk. Be careful not to
touch the surfaces of the reaction cells.

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11 10

A Indented part of ultrasonic mixer

Figure C-25 Cleaning the incubator bath

While the analyzer is in Maintenance mode or Shutdown status, perform the

following to clean the incubator bath.
9 Using a clean lint-free gauze pad, wipe the inside surfaces of the incubator bath.

NOTICE Damage to the photometer windows

o Do not scratch the photometer windows when cleaning.
o Use only gauze pads moistened with deionized water or 2% Hitergent solution.

10 Moisten a clean lint-free gauze pad with deionized water or 2% Hitergent

solution. Wipe the photometer windows carefully in order to avoid scratching
them.
11 Wipe the indented part of the ultrasonic mixer (A) with a cotton swab moistened
with DI water.
Now, continue with the next procedure: To clean the drain filter of the incubator
bath.

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a To clean the drain filter of the incubator bath

Figure C-26 Removing the drain filter of the incubator bath

1 Remove the incubator bath drain filter. Grasp the filter by its handle and pull the
filter out.
2 Wash the filter with tap water, rinse it with deionized water and return it to its
place.
In case you are only performing monthly maintenance, continue with the next
procedure: To reinstall reaction parts and to terminate the incubator bath cleaning
mode.
Otherwise we recommend continuing with the following items:
e For quarterly maintenance, see
M15: Cleaning the ultrasonic mixer on page C-79
e For every six months maintenance, see
M21: Replacing the photometer lamp on page C-96

a To reinstall reaction parts and to terminate the incubator bath cleaning

mode
1 Place all segments of reaction cells (cleaned or new cells).
2 Return the cell rinse unit, the sipper cover and the cell covers.
3 Close the top cover of the analyzer and lock it.
4 Switch on the analytical unit and the control unit.
The incubator bath is filled with some water. A yellow alarm is issued, indicating
that the level of incubation water is below the lower limit.
5 Perform maintenance item (4) Incubation Water Exchange.
The incubator is exchanged and Hitergent (4.3 mL) is added.
6 Perform maintenance item (6) Wash Reaction Parts.

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7 Perform maintenance item (3) Cell Blank Measurement to verify the integrity of
the reaction cells and to compensate for a potential change in light intensity after
the cleaning of the photometric windows.
e For detailed instructions, see:
To wash the reaction parts on page C-51
To perform a cell blank measurement on page C-51

M10: Cleaning the ISE Ref. aspiration filter

Inspect the ISE Ref. aspiration filter, which is attached to the tube end in the ISE Ref.
bottle. Clean the filter each time you replace the ISE Ref. bottle but at least once a
month. Clogging of the filter will reduce the accuracy of ISE Ref. aspiration and data
reliability.
This maintenance action comprises the following procedures:
1. To clean the ISE Ref. aspiration filter
2. To reset the remaining volume of ISE Ref.
3. To prime the ISE Ref. tubing
Operator time: approximately 5 minutes
System time: approximately 2 minutes

Materials required m Paper towel

m Deionized water

a To clean the ISE Ref. aspiration filter

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

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Figure C-27 Cleaning the ISE Ref. aspiration filter

3 Remove the tubing from the ISE Ref. bottle and unscrew the filter from the tube
end.
4 Wash the filter with tap water.
5 Rinse the filter with deionized water.
6 Replace the ISE Ref. bottle if necessary.
7 Finally, screw the filter on the tube end and place it back into the bottle.
8 Close the top cover of the analyzer and lock it.
9 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status).The analyzer returns to Standby.
10 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
11 If you have replaced the ISE Ref. bottle, reset the remaining volume.
e See: To reset the remaining volume of ISE Ref. on page C-68

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a To reset the remaining volume of ISE Ref.

1 Choose Reagent > Setting.
2 Select REF in the Type column.
The line ISE REF is highlighted.
3 Choose Reagent Level Reset button.
4 A confirmation window opens; choose Yes.
After reset, an initial value of 279 ml is displayed in the column Available Tests.

a To prime the ISE Ref. tubing

When the ISE Ref. aspiration filter was cleaned or the ISE Ref. bottle was replaced, air
may have entered into the ISE electrodes. So it is important to perform a reagent
prime for the ISE Ref. tubing.
e For information about the reagent consumption, see:
(7) Reagent Prime on page C-22

1 Choose Utility > Maintenance.

2 Select Maintenance (1) from the Maintenance Type list on the left.
3 Select (7) Reagent Prime from the Maintenance Items list on the right.
4 Choose Select to open the Reagent Prime window.
5 Choose Parameter to open the Reagent Parameter Setting window.
6 Select REF and choose OK.
The Reagent Prime window reappears.
7 Choose Execute.
The prime is complete when the system returns to Standby.
8 If you have replaced the ISE Ref. bottle, perform an ISE calibration before you
resume routine operation.
e For details on how to calibrate the ISE unit, see:
Requesting and cancelling calibrations manually on page B-123.

M11: Cleaning the detergent aspiration filters

Inspect the detergent aspiration filters, which are attached to the tube end in the cell
detergent bottles. The cell detergent bottles (Cell wash I and Cell wash II) are located
behind the left front door. Clean the filter each time you replace a bottle but at least
once a month. Clogging of the filter will reduce the accuracy of detergent aspiration
and will lead to insufficient cell cleaning.
This maintenance action comprises the following procedures:
1. To clean the detergent aspiration filters
2. To reset the remaining volume
3. To perform a cell detergent prime
Operator time: approximately 5 minutes

Materials required m Paper towel

m Deionized water
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a To clean the detergent aspiration filters

1 The analyzer can be either in Standby, Maintenance mode, or Shutdown status.
2 Open the left front door of the analyzer and take out the detergent bottle(s).

4
3

A Filter for Cell wash I (with square end)

B Filter for Cell wash II (with round end)

Figure C-28 Cleaning the detergent aspiration filters

3 Remove the tubing from the detergent bottle(s) and unscrew the filter from the
tube end.

Cell wash I has a filter with a square end.

Cell wash II has a filter with a round end.

4 Wash the filters with tap water.

5 Rinse the filters with deionized water.
6 Screw the filter onto the tube end.

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14 Maintenance of the analyzer cobas c 311 analyzer
Monthly maintenance

Incorrect results due to incorrect insertion of aspiration tube

If the aspiration tube is not inserted correctly, the detergent may not be dispensed
CAUTION properly. This may lead to incorrect results.
o Insert the aspiration tube so that the end of the tube touches the bottom of the bottle.
o Do not bend the aspiration tube.

7 Insert the tube back into the bottle.

8 If you have replaced a detergent bottle, it is necessary to reset the remaining
volume and to perform maintenance item (8) Cell Detergent Prime.

a To reset the remaining volume

1 If the analyzer was in Maintenance mode or shutdown:
o Ensure the top cover of the analyzer is locked.
o Turn the maintenance switch back to Operation mode (or power up the
analyzer if it was in Shutdown status).
2 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
3 Choose Reagent > Status.
4 Select the detergent which you have replaced.
5 Choose Inventory Set and confirm with OK.
Cell wash I and II is reset to 1800 mL.

a To perform a cell detergent prime

After replacing a bottle, the detergent in the tubing is purged of air before starting
analysis.
1 Choose Utility > Maintenance.
2 Choose (8) Cell Detergent Prime on the Maintenance Items list on the right.
3 Choose Select to open the Cell Detergent Prime window.

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Monthly maintenance

Figure C-29 Cell Detergent Prime window

4 Select an option in the Detergent area to specify which line is to be primed:

Detergent 1 (Cell wash I), Detergent 2 (Cell wash II), or Detergent 1 and 2
(Cell wash I and II).
5 Choose Execute.

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14 Maintenance of the analyzer cobas c 311 analyzer
Monthly maintenance

M12: Cleaning the radiator filter

Clean the radiator filter of the cooling unit at least once a month to prevent dust or
dirt accumulation. Clogging of the filter may cause the analyzer to overheat.
Operator time: approximately 5 minutes

Materials required m Vacuum cleaner

m Paper towels
m Water for rinsing

a To clean the radiator filter

1 The analyzer can be either in Standby, Maintenance mode, or Shutdown status.
2 Open the front doors.

3
5

Figure C-30 Cleaning the radiator filter

3 Vacuum the radiator filter and the radiator fins.

4 If there is a lot of particulate matter (i.e. dust), remove the filter by pulling it
forward from the retaining brackets.
5 Wash the filter with tap water and dry it completely with paper towels.
6 Reinstall the filter.
7 Close the front doors of the analyzer.

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cobas c 311 analyzer 14 Maintenance of the analyzer
Monthly maintenance

M13: Washing flow path of concentrated waste solution

The concentrated waste solution may be clogged if dirt or crystallizations accumulate

in the flow path. Wash the flow path with acidic detergent once a month.
Operator time: approximately 1 minute
System time: approximately 21 minutes

Materials required m Cell wash II (Acid Wash)

a To wash the reaction system

1 Make sure that the analyzer is in Standby.
2 Choose System overview > Reagent overview.

Figure C-31 Check the remaining amount of Cell Cleaner 2

3 Check the remaining amount of detergent. If insufficient, add a new detergent

bottle.

Detergent Detergent Position Consumption

Cell cleaner 2 Cell wash II/Acid Wash Left front door approx. 30 mL
Table C-22 Detergent consumption

o If it is necessary to replace a detergent bottle:

e To replace a cell detergent bottle on page B-109
e To clean the detergent aspiration filters on page C-69

4 Choose Utility > Maintenance.

5 Choose Maintenance (1) on the Maintenance Types list on the left.
6 Choose (12) Flow Path Wash on the Maintenance Items list on the right.
7 Choose Select to open the Flow Path Wash window.
8 Choose Execute.
The flow path, the concentrated waste reservoir, and the drainage tube are
cleaned. The procedure is finished when the analyzer returns to Standby.

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14 Maintenance of the analyzer cobas c 311 analyzer
Every two months maintenance

Every two months maintenance

In this section you will find all the maintenance actions that must be performed at
least once every two months.

Before performing this maintenance action, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page C-3
o Infection by waste solution on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

M14: Replacing ISE measuring cartridges (Cl, K, Na)

The electrical response level and the slope value (sensitivity) of each measuring
cartridge slightly decrease with time and use. Replace an ISE measuring cartridge if
one of the following criteria is met:
o The cartridge has been in service more than 2 months.
o The test count has reached 9000 tests.
o The slope value of the cartridge falls outside of the normal range.
In the latter case, an alarm is issued as described in the figure below.

Na+, K+ Slop.E Prep.E (Normal range) Cond.E

+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV

Cl– Cond.E (Normal range) Prep.E Slop.E

- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV

Figure C-32 ISE data alarms and corresponding slope values (EMF values)

Judgement on ISE measuring cartridge replacement

o If the alarm “ISE slope marginal (Prep.E)” appears, you may continue the day’s analyses
but the cartridges must be replaced the next day. Check the QC to verify that the slope
is acceptable.
o If the alarm “ISE slope error (SlopeE)” appears, replace the cartridges at once.
o Normally, the slope values slightly decrease with time and use. If there is a large
change, the cause may be other than the electrodes. Check for air bubbles in or
leakage from the flow path, an error in substitution of standard solution, contamination
of the flow path, etc.

This maintenance action comprises the following procedures:

1. To replace ISE measuring cartridges
2. To prime lines
3. To perform an ISE Check and calibrate the ISE unit
Operator time: approximately 10 minutes

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System time: approximately 56 minutes (10 minutes for (7) Reagent Prime (IS+REF),
2*18 minutes for (2) ISE Check, plus 10 minutes in between)

Materials required m Sodium (Na+) cartridge

m Potassium (K+) cartridge
m Chloride (Cl–) cartridge
m Lint-free gauze pads
m Tweezers
m Reference solution ISE Ref.
m Internal standard ISE IS

a To replace ISE measuring cartridges

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

Figure C-33 Removing ISE covers and disconnecting electrode wires

3 Remove the sipper cover and the cover of the ISE measuring compartment.
4 Disconnect the four electrode wires (Cl, K, Na and REF).
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Every two months maintenance

Figure C-34 Removing ISE cartridges and wiping up spilled liquid

5 Pull the release lever toward the RELEASE position to loosen the cartridges from
the mounting block. The lever is equipped with a spring—take care of your
fingers.
6 Use large tweezers to remove the cartridges from the mounting block.
7 During the replacement:
o Thoroughly wipe up any spilled liquid or liquid adhering to connecting parts.
Remaining liquid on ion selective electrodes may lower measurement
precision.
o If an O-Ring from the cartridges remains inside the ISE measuring
compartment, use tweezers to remove it.
8 Insert the new cartridges in the right color-coded position into the ISE measuring
compartment while holding the lever at RELEASE.

Verify that the connecting part and the new cartridges are provided with O-rings, but be
sure to remove the black rubber protectors that are located over the O-ring receptacles on
the cartridges.

9 Set the lever at LOCK to fasten the cartridges, then reconnect the four color-coded
electrode cords to their respective cartridges.
10 Replace the sipper cover and the cover of the ISE measuring compartment.

Incorrect results due to missing covers of the ISE unit

If the cover of the ISE measuring compartment or the cover of the sipper nozzle are not
CAUTION reinstalled after maintenance, the temperature level or the noise level may be affected,
leading to incorrect results.
Always reinstall the covers of the ISE unit after performing maintenance.

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a To prime lines
e For information about reagent consumption, see:
(7) Reagent Prime on page C-22

1 Close the top cover of the analyzer and lock it.

2 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
3 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
4 Choose Utility > Maintenance.
5 Select Maintenance (1) from the Maintenance Type list on the left.
6 Select (7) Reagent Prime from the Maintenance Items list on the right.
7 Choose Select to open the Reagent Prime window.
8 Choose Parameter to open the Reagent Parameter Setting window.
9 Choose IS+REF in the ISE area (or REF after replacement of the reference
cartridge) and OK.
10 Back in the Reagent Prime window, choose Execute.
The reagent prime is complete when the analyzer returns to Standby.

a To perform an ISE Check and calibrate the ISE unit

After installing new ISE cartridges, proceed with an ISE check to condition the
electrodes and then calibrate the ISE unit before you resume routine analysis.
1 Choose Utility > Maintenance.
2 Select Check (2) from the Maintenance Type list on the left.
3 Select (2) ISE Check from the Maintenance Items list on the right.
4 Choose Select, to open the ISE Check window.
5 Enter 10 at Cycles and choose Execute.
The electromotive force (EMF) values of the internal standard solution are
printed 10 times for each electrode. At this point, the results can be ignored.
6 After waiting ten minutes, execute another ISE check (10 cycles).
Make sure the printed EMF values of the internal standard solution are normal
and the difference in successive values for the same electrode are stable within
± 0.2 mV. Otherwise retry ISE check.
If an EMF value is abnormal (level error or noise error for example), the
corresponding alarm name will be printed out.
e See ISE data alarms and corresponding slope values (EMF values) on page C-74.

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14 Maintenance of the analyzer cobas c 311 analyzer
Every two months maintenance

ISE Check 07/07/31 10:46

NO NA EMF K EMF CL EMF REF EMF

1 -65.2 -71.5 102.7 0.2
2 -65.2 -71.6 102.8 0.2
3 -65.1 -71.7 102.8 0.2
4 -65.0 -71.8 102.9 0.3
5 -65.0 -72.0 103.1 0.2
6 -64.9 -72.0 103.2 0.3
7 -64.8 -72.1 103.4 0.3
8 -64.7 -72.1 103.6 0.2
9 -64.6 -72.1 103.7 0.1
10 -64.5 -72.1 103.8 0.0
11 -65.2 -71.5 102.7 0.2
12 -65.2 -71.6 102.8 0.2
13 -65.1 -71.7 102.8 0.2
14 -65.0 -71.8 102.9 0.3
15 -65.0 -72.0 103.1 0.2
16 -64.9 -72.0 103.2 0.3
17 -64.8 -72.1 103.4 0.3
18 -64.7 -72.1 103.6 0.2
19 -64.6 -72.1 103.7 0.1
20 -64.5 -72.1 103.8 0.0

Figure C-35 ISE Check report

7 Calibrate the ISE unit according to the procedure described.

e For details on how to calibrate the ISE unit, see:
Requesting and cancelling calibrations manually on page B-123.

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Quarterly maintenance

Quarterly maintenance

In this section you will find all the maintenance actions that must be performed at
least once every three months.

Before performing any maintenance actions, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page C-3
o Infection by waste solution on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

e This section discusses the following maintenance actions:

M15: Cleaning the ultrasonic mixer on page C-79
M16: Replacing the ISE pinch valve tubing on page C-82
M17: Replacing the ISE sipper tubing on page C-84
M18: Replacing the syringe seals on page C-85

M15: Cleaning the ultrasonic mixer

Clean the ultrasonic mixer at least once every three months. Contamination and
precipitation on the surface of the ultrasonic mixer may cause inadequate mixing and
thus lead to inaccurate results.

Replacement of ultrasonic mixer

The ultrasonic output intensity is continually monitored during measurement. If the data
alarm <MIX occurs frequently, the ultrasonic mixer needs to be replaced. Contact your
service representative for a replacement.

This maintenance action can be combined with the monthly maintenance action M9:
Replacing reaction cells and cleaning incubator bath on page C-62.

This maintenance action comprises the following procedures:

1. To clean the surface of the ultrasonic mixer
2. To check the intensity of the ultrasonic output
Operator time: approximately 10 minutes
System time: approximately 5 minutes

Materials required m Cotton swabs

m Paper towels
m Hitergent cassette (surfactant for the incubator, consumption 4.3 mL)
m 2% Hitergent solution
m Deionized water

Before performing this maintenance action, observe the following safety

precautions:
o Electrical shock by electronic equipment on page A-8

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14 Maintenance of the analyzer cobas c 311 analyzer
Quarterly maintenance

a To clean the surface of the ultrasonic mixer

1 Choose System Overview > Reagent Overview screen.
2 Check the remaining amount of Hitergent. If insufficient, add a new cobas c pack.
3 Put the analyzer in incubator bath cleaning mode.
To put the analyzer in incubator bath cleaning mode:
o Choose Utility > Maintenance.
o Select Maintenance (1) from the Maintenance Type list on the left.
o Select (9) Incubator Bath Cleaning from the Maintenance Items list on the
right.
o Choose Select to open the Incubator Bath Cleaning window.
o Choose Execute. The water is drained from the incubator bath and the control
unit is powered off.
4 After the computer power supply has powered off, switch off power for the
analytical unit.

Do not open the top cover of the analyzer until the analyzer is in shutdown.

5 Unlock and open the top cover of the analyzer.

6/7

A
A Polished surfaces of the ultrasonic mixer

Figure C-36 Cleaning the surfaces of the ultrasonic mixer with cotton swabs

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6 Remove the cell cover attached to the ultrasonic mixer.

7 Remove the segment of reaction cells near the ultrasonic mixer. Be careful not to
touch the surfaces of the reaction cells.
8 Gently wipe the polished surfaces of the ultrasonic mixer (A) with a cotton swab
moistened with 2% Hitergent solution. Then, wipe off the detergent with a cotton
swab moistened with deionized water.
9 Put the reaction cells back in place. In case you are re-using used reaction cells, be
sure to put them back in their previous positions.
10 Return the cell cover.
11 Close the top cover of the analyzer and lock it.
12 Switch on the analytical unit and the control unit.
The incubator bath is filled with some water. A yellow alarm is issued, indicating
that the level of incubation water is below the lower limit.
13 Perform maintenance item (4) Incubation Water Exchange.
The incubator is filled up completely and Hitergent (4.3 mL) is added.

a To check the intensity of the ultrasonic output

1 Choose Utility > Maintenance.
2 Select Check (2) from the Maintenance Type list on the left.
3 Select (6) Cuvette Mixing from the Maintenance Items list on the right.
4 Choose Select to open the Cuvette Mixing window.
5 Enter 10 in the Cycles text box and choose Execute.
In case an alarm occurs, follow the remedies described in the alarm message.
In case you are also performing monthly maintenance action M9: Replacing reaction
cells and cleaning incubator bath, continue with Step 6 of To reinstall reaction parts and
to terminate the incubator bath cleaning mode on page C-65.
In case you also want to perform every six months maintenance action M21:
Replacing the photometer lamp, continue with M21: Replacing the photometer lamp on
page C-96.

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Quarterly maintenance

M16: Replacing the ISE pinch valve tubing

After long use, the tubing will gradually wear out and the accuracy of sample
aspiration will decrease. Replace the ISE pinch valve tubing once every three months.
Operator time: approximately 6 minutes
System time: approximately 46 minutes (2*18 minutes for (2) ISE Check, plus
10 minutes in between)

Materials required m Pinch valve tubing

a To replace the ISE pinch valve tubing

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

A Pinch valve

Figure C-37 Replacing the ISE pinch valve tubing

3 Remove the sipper cover and the cover of the ISE measuring compartment.

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4 Gently remove both ends of the ISE pinch valve tubing from their tube connectors
and pull the tubing through the pinch valve (A). Discard the old tubing.
5 Insert the new tubing through the pinch valve and attach both ends of the tubing
to the connectors. Make sure that there is no slack in the tubing.
In case you also want to replace the ISE sipper tubing, continue with Step 4 of
M17: Replacing the ISE sipper tubing on page C-84. Perform the ISE Check
afterwards.

Incorrect results due to missing covers of the ISE unit

If the cover of the ISE measuring compartment or the cover of the sipper nozzle are not
CAUTION reinstalled after maintenance, the temperature level or the noise level may be affected,
leading to incorrect results.
Always reinstall the covers of the ISE unit after performing maintenance.

6 Replace the sipper cover and the cover of the ISE measuring compartment.
7 Close the top cover of the analyzer and lock it.
8 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
9 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
10 Perform maintenance check (2) ISE Check (10 cycles) to condition the electrodes.
11 After waiting 10 minutes, perform maintenance check (2) ISE Check (10 cycles)
again. Check the printed EMF values. Then calibrate the ISE unit before you
resume routine analysis.
e See To perform an ISE Check and calibrate the ISE unit on page C-77.

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Quarterly maintenance

M17: Replacing the ISE sipper tubing

After long use, the tubing will gradually wear out and the accuracy of sample
aspiration will decrease. Replace the ISE sipper tubing once every three months.
Operator time: approximately 6 minutes
System time: approximately 46 minutes (2*18 minutes for (2) ISE Check, plus
10 minutes in between)

Materials required m ISE sipper tubing

a To replace the ISE sipper tubing

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

A Arm cover of the sipper nozzle

Figure C-38 Replacing the ISE sipper tubing

3 Remove the sipper cover, the arm cover of the sipper nozzle, and the cover of the
ISE measuring compartment.
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Quarterly maintenance

4 Gently remove both ends of the ISE sipper tubing from the tube connectors.
Discard the old tubing.
5 Attach both ends of the new tubing to the tube connectors.
In case you also want to replace the ISE pinch valve tubing, continue with Step 4
of M16: Replacing the ISE pinch valve tubing on page C-82.

Incorrect results due to missing covers of the ISE unit

If the cover of the ISE measuring compartment or the cover of the sipper nozzle are not
CAUTION reinstalled after maintenance, the temperature level or the noise level may be affected,
leading to incorrect results.
Always reinstall the covers of the ISE unit after performing maintenance.

6 Replace the arm cover of the sipper nozzle, the cover of the ISE measuring
compartment, and the sipper cover.
7 Close the top cover of the analyzer and lock it.
8 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
9 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
10 Perform maintenance check (2) ISE Check (10 cycles) to condition the electrodes.
11 After waiting 10 minutes, perform maintenance check (2) ISE Check (10 cycles)
again. Check the printed EMF values. Then calibrate the ISE unit before you
resume routine analysis.
e See To perform an ISE Check and calibrate the ISE unit on page C-77.

M18: Replacing the syringe seals

Replace the syringe seals every three months or after 112,500 samples for the reagent
and sample syringe or after 56,250 samples for the ISE sipper syringe. Worn-out
syringe seals can cause leakage and inaccurate pipetting.
There are three syringes behind the left front door of the cobas c 311 analyzer
(Figure C-39). The procedure for replacing the syringe seals is the same for all
syringes. Note, however, that there are different spare parts for each of the three
syringe types (sample, reagent, and ISE sipper syringe).

o The reagent syringe is used as an example in the rest of this section. All illustrations
show the reagent syringe.
o We recommend completing the procedures for the first syringe before starting with the
next. Do not dismount more than one syringe at the same time because the internal
parts of the syringes differ and may be mistaken easily with each other.

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A
B

A Reagent syringe C ISE sipper syringe

B Sample syringe

Figure C-39 Syringe positions

This maintenance action comprises the following procedures:

1. To remove the syringe
2. To replace the syringe seals
3. To reattach the syringe
4. To perform an air purge (sample syringe or reagent syringe)
5. To perform a reagent prime (ISE sipper syringe)
6. To check syringe connections
Operator time: approximately 15 minutes
System time: approximately 10 minutes

Materials required m Seals and spacer

m Spanner wrench
m Lint-free gauze pads
m Deionized water

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Quarterly maintenance

a To remove the syringe

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Open the left front door of the analyzer and locate the syringes.

3 4 5

A
B

C
D
B

A Tube connectors B Syringe holder C Syringe

D Thread of the syringe holder

Figure C-40 Removing the syringes

3 To disconnect the tubing at the top and bottom of the syringe, loosen and remove
the upper and lower tube connectors (A). Use a dry gauze pad to absorb any liquid
leaking from the tubing or syringe.
4 Loosen the syringe holder (B) and lift it up about 1 cm (lift it up over the thread
(D) of the syringe holder).
5 Remove the syringe (C) by carefully pulling it toward you.
6 Place the removed syringe on a dry gauze pad.

NOTICE Damage to the syringes due to cleaning with detergent

Clean the syringes only with deionized water.

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Quarterly maintenance

a To replace the syringe seals

D
H

A Spanner wrench C Upper seal piece F Spring

B Syringe barrel D Spacer G Retaining screw
E Lower seal piece H Plunger

Figure C-41 Replacing the syringe seals

1 Loosen the retaining screw (G) with the spanner wrench (A). Be careful not to
bend the plunger.
2 Carefully remove the plunger (H) together with the retaining screw (G) and the
syringe seals (C, E) from the syringe barrel.

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Reagent syringe Sample syringe ISE sipper syringe

I
E

G
I

A Spanner wrench (see Figure C-41) F Spring

B Syringe barrel (see Figure C-41) G Retaining screw
C Upper seal piece H Plunger
D Spacer I Grooves of ISE sipper seals
E Lower seal piece

Figure C-42 Mounting order of syringe parts

3 Remove the upper seal piece (C), spacer (D), and lower seal piece (E) from the
plunger (H).
4 If the plunger, syringe or spacer are contaminated, wipe them with a gauze pad or
cotton swab moistened with deionized water.
5 Mount the retaining screw, spring, new lower seal piece, spacer, and new upper
seal piece onto the plunger as shown in Figure C-42.

o Be careful not to mistake the orientation of syringe seals and spacer!

o The seals are different in shape for each of the three types of syringe. Check the part
numbers that you have the correct seal before mounting.

NOTICE Damage to the syringe seals

Do not overtighten the retaining screw. If the retaining screw is overtightened, the syringe
seals wear out quickly and the plunger may bend or break, requiring replacement.

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Quarterly maintenance

6 Place the plunger (H) in the syringe barrel (B). Check that the spring (F) is
centered on the lower seal piece (E). If the spring is not centered, it could be
damaged during tightening.
7 Tighten the retaining screw with the spanner wrench.

a To reattach the syringe

1 To reattach the syringe, follow the instructions for removing in the reverse order.
e To remove the syringe on page C-87

2 Finally, it is important to check the connections. To do this you must first perform
either maintenance item (5) Air Purge or (7) Reagent Prime.
o If you are working on the ISE sipper syringe, perform maintenance item (7)
Reagent Prime and select IS+REF.
e For detailed instructions, see To perform a reagent prime (ISE sipper syringe) on
page C-91.
o If you are working on the sample syringe or the reagent syringe, perform an air
purge following the instructions below:

a To perform an air purge (sample syringe or reagent syringe)

1 Ensure the top cover is locked, before you switch on the analyzer again.
2 Choose Utility > Maintenance.
3 Select Maintenance (1) from the Maintenance Type list on the left.
4 Select (5) Air Purge from the Maintenance Items list on the right.
5 Choose Select to open the Air Purge window.

AU = Analytical Unit (refers to the photometric unit here)

Figure C-43 Air Purge window

6 Choose the syringe to be purged of air in the Syringe area and choose Execute.
The respective pipetter will operate. At the rinse station, water as well as any air
are discharged from the probe.

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7 After air purge, check connections following the instructions below.

e See To check syringe connections on page C-91.

8 Repeat steps 2-7 for other syringe.

a To perform a reagent prime (ISE sipper syringe)

e For information about the reagent consumption, see:
(7) Reagent Prime on page C-22

1 Ensure the top cover is locked, before you switch on the analyzer again.
2 Choose Utility > Maintenance.
3 Select Maintenance (1) from the Maintenance Type list on the left.
4 Select (7) Reagent Prime from the Maintenance Items list on the right.
5 Choose Select to open the Reagent Prime window.
6 Choose Parameter to open the Reagent Parameter Setting window.
7 Choose IS+REF in the ISE area and OK.
8 Back in the Reagent Prime window, choose Execute.
9 After reagent prime, check connections following the instructions below.

a To check syringe connections

1 After the reagent prime or air purge (in Standby mode), open the front door.
2 Check the following conditions:
o There is no leakage from any of the connections (see Figure C-44).
o There are no air bubbles in the syringe barrel (see Figure C-44).

Incorrect results due to loose tube connectors

A loose tube connector may cause insufficient pipetting and result in inaccurate
CAUTION measurement.
o Tighten the tube connector securely and make sure there is no liquid leakage.
o Observe the system safety labels illustrated from page A-15 to A-18 and in particular
the following: F-2.

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A Check for leakage B Check for air bubbles

Figure C-44 Checking syringe for leakage and air bubbles

3 Inspect the syringe to ensure that no air remains in the syringe and no leaks are
visible at any of the fittings.
o If leakage is found at the syringe holder or tube connector, try to tighten.
o If leakage is found at the bottom of the syringe, try to attach again.
o If there are any air bubbles visible in the syringe, remove them by lightly
tapping your finger against the syringe while the liquid is flowing.

If bubbles cannot be removed, disconnect the syringe again (see To remove the syringe on
page C-87). Then wipe the plunger with gauze moistened with deionized water (see To
replace the syringe seals on page C-88).

4 Close the front door.

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C-92 Operator’s Manual · Version 1.0
cobas c 311 analyzer 14 Maintenance of the analyzer
Every six months maintenance

Every six months maintenance

In this section you will find all the maintenance actions that must be performed at
least once every six months.

Before performing any maintenance actions, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page C-3
o Infection by waste solution on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

e This section discusses the following maintenance actions:

M19: Cleaning the inlet water filter on page C-93
M20: Cleaning the cooling fan on page C-95
M21: Replacing the photometer lamp on page C-96
M22: Replacing the ISE reference cartridge on page C-101

M19: Cleaning the inlet water filter

Clean the inlet water filter at least once every six months to prevent clogging of the
water system.
Operator time: approximately 5 minutes

Materials required m Water pump filter (in case replacement is required)

m Paper towels
m Beaker or container, 500 mL
m Deionized water

Incorrect results due to loose water filter cap

If the water supply filter is clogged or the inlet water hose is not reconnected to the inlet
CAUTION water manifold correctly, it may cause instrument malfunction and result in inaccurate
measurement.
o Clean the filter regularly.
o Reconnect the inlet water hose to the inlet water manifold correctly.
o Observe the system safety labels illustrated from page A-15 to A-18 and in particular
the following: R-2.

a To clean the inlet water filter

1 Turn off the external water supply.
2 Shut down the analyzer.

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Operator’s Manual · Version 1.0 C-93
14 Maintenance of the analyzer cobas c 311 analyzer
Every six months maintenance

A Inlet water filter

Figure C-45 Cleaning the inlet water filter

3 Hold the hose up when it is disconnected to prevent spilling of water.

Or: Place a 500 mL beaker (or similarly appropriate container) beneath the inlet
water manifold.
4 Turn the ring on the water filter cap counterclockwise and disconnect the inlet
water hose.
5 Remove the water filter and place the hose in the container. Be careful not to
overturn the container.
6 Clean the filter thoroughly with deionized water, then reinstall the filter.

After cleaning, tighten the filter cap securely and make sure there is no water leakage.

7 Reconnect the inlet water hose to the inlet water manifold.

8 Turn on the external water supply.
9 Ensure the top cover is locked, before you switch on the analyzer again.

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cobas c 311 analyzer 14 Maintenance of the analyzer
Every six months maintenance

M20: Cleaning the cooling fan

Clean the cooling fan at the rear of the analyzer to remove dust and dirt.
Operator time: approximately 5 minutes

Materials required m Vacuum cleaner

a To clean the cooling fan

Personal injury through touching the fan

There is a grill to protect the operator from coming into contact with the moving fan. Do
WARNING not insert your fingers in the openings of the ventilation grill. If the fan is cleaned when the
analyzer is not in Shutdown status, there is a danger of injury.
Therefore shut down the analyzer before cleaning.

Figure C-46 Cleaning the cooling fan

1 Make sure that the analyzer is in Shutdown status.

2 Vacuum dust, dirt, and other debris from the cooling fan at the back of the
analyzer.
3 Close the top cover of the analyzer and lock it (or: continue with the next
maintenance action in Shutdown status).

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Operator’s Manual · Version 1.0 C-95
14 Maintenance of the analyzer cobas c 311 analyzer
Every six months maintenance

M21: Replacing the photometer lamp

The reproducibility of measurement will decrease if the photometer lamp

deteriorates. Replace the photometer lamp if the lamp has been used for more than
six months (or 750 hours(a)) or if the photometer check value exceeds 14000.
We recommend combining this maintenance action with the monthly cleaning of the
incubator bath and with the quarterly cleaning of the ultrasonic mixer.
This maintenance action comprises the following procedures:
1. To check the light intensity
2. To remove the photometer lamp
3. To install a new photometer lamp
4. To perform a cell blank measurement
Operator time: approximately 10 minutes
System time: approximately 17 minutes

Materials required m Lint-free gauze pads

m Photometer lamp

a To check the light intensity

We recommend checking the light intensity daily to maintain reproducibility of
measurement. The photometer check can be included in a Start Up or Power ON
pipe.
1 Choose Utility > Maintenance.
2 Select Maintenance (1) from the Maintenance Type list on the left.
3 Select (2) Photometer Check from the Maintenance Items list on the right.
4 Choose Select to open the Photometer Check window.
5 Select Execute.
Water is injected from the rinsing mechanism into reaction cell no. 1 and the
absorbance of the water is measured for each available wavelength.
6 After the photometer check, select Print (global button) to open the Print
window.
7 Select Print (or View) > Utility > Photometer Check to check the absorbance
values of the current photometer check.

(a) This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the analyzer
by looking at the printed Maintenance Report (Print > Utility > Maintenance Report).

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cobas c 311 analyzer 14 Maintenance of the analyzer
Every six months maintenance

Photometer Check 8:20

---------------PREVIOUS DATA--------------- ---------------CURRENT DATA---------------
c311 DATE 07/08/1 8:20 DATE 07/08/2 8:18
340 nm 10386 340 nm 10386
376 nm 10358 376 nm 10358
415 nm 9534 415 nm 9534
450 nm 9275 450 nm 9275
480 nm 9195 480 nm 9195
505 nm 9130 505 nm 9130
546 nm 8984 546 nm 8984
570 nm 8967 570 nm 8967
600 nm 8929 600 nm 8929
660 nm 8676 660 nm 8676
700 nm 8657 700 nm 8657
800 nm 8594 800 nm 8594

Figure C-47 Photometer check report

If the current readings exceed 14000 at any wavelength, check the following points
and then replace the photometer lamp:
o Verify that the reaction cells, the incubator bath, and the photometric windows
are free of contamination or bubbles.
o Verify that the reaction cells are not scratched or cracked.
o Verify that reaction cell no. 1 is at least half filled with water.
If the current data value is quite different from the previous one, check if one of the
above applies.

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Operator’s Manual · Version 1.0 C-97
14 Maintenance of the analyzer cobas c 311 analyzer
Every six months maintenance

Burns due to hot surface!

You may burn yourself if you touch any part of the photometer lamp unit.
WARNING o Wait about 30 minutes after turning off lamp power.
o Check that the photometer lamp unit has cooled down before replacing the lamp.
o Observe the system safety labels illustrated from page A-15 to A-18 and in particular
the following: T-1.

Before performing this maintenance action, observe the following safety

precautions:
o Malfunction due to spilled liquid on page C-4

a To remove the photometer lamp

1 Shut down the analyzer. This is necessary to switch off power for the photometer
lamp.
2 Wait about 30 minutes for the lamp and lamp housing to cool down.
3 Unlock and open the top cover of the analyzer.

Figure C-48 Removing the reaction disk

4 Remove cell rinse unit, sipper cover and cell covers.

5 Remove each segment of reaction cells from the reaction disk. Be careful not to
touch the surfaces of the reaction cells.

If the reaction disk is detached with the reaction cells left in place, water drops adhering to
the outside of the reaction cells may drip onto the space surrounding the photometer lamp.
This may cause an alarm to be issued.

6 Loosen the three retaining screws and remove the reaction disk from the system.

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cobas c 311 analyzer 14 Maintenance of the analyzer
Every six months maintenance

A Connector cover

Figure C-49 Removing the photometer lamp

7 Rotate the connector cover (A) counterclockwise and disconnect the connector of
the lamp wire.
8 Loosen the two lamp retaining screws and take out the photometer lamp.
When the screws become loose and turn easily, the lamp can be detached.

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Operator’s Manual · Version 1.0 C-99
14 Maintenance of the analyzer cobas c 311 analyzer
Every six months maintenance

a To install a new photometer lamp

1/2

Figure C-50 Installing a new photometer lamp

1 Insert the new photometer lamp.

2 Align the pin hole in the lamp base with the guide pin of the lamp housing and
tighten the two lamp retaining screws.

Be careful not to touch the glass part of the new photometer lamp. If you do touch the
glass, wipe it off with a gauze pad.

3 Connect the connectors of the lamp wires.

Secure the lamp wires by wrapping them around the plastic retaining hook.
4 Reinstall the reaction disk and reaction cells and put the cell covers and sipper
cover back in place.
5 Return the cell rinse unit to its original position.
6 Close the top cover of the analyzer and lock it (or: continue with the next
maintenance action in Shutdown status).
7 Switch on the analyzer again.
8 Wait 30 minutes for the photometer lamp to stabilize and perform a cell blank
measurement before you resume routine operation. This is necessary to
compensate for a potential change in light intensity.
e For instructions, see To perform a cell blank measurement on page C-51.

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C-100 Operator’s Manual · Version 1.0
cobas c 311 analyzer 14 Maintenance of the analyzer
Every six months maintenance

In case you are also performing the monthly maintenance action M9: Replacing
reaction cells and cleaning incubator bath, continue with Step 6 of To reinstall
reaction parts and to terminate the incubator bath cleaning mode on page C-65.
This includes a cell blank measurement.

M22: Replacing the ISE reference cartridge

Like any ISE cartridge, the ISE reference cartridge slowly deteriorates with use over
time. Eventually, the electromotive force (EMF) values of all cartridges may become
unstable. Therefore, replace the reference cartridge every six months.
This maintenance action comprises the following procedures:
1. To replace the ISE reference cartridge
2. To prime lines
3. To perform an ISE Check and calibrate the ISE unit
Operator time: approximately 5 minutes
System time: approximately 48 minutes (2 minutes for (7) Reagent Prime (REF),
2*18 minutes for (2) ISE Check, plus 10 minutes in between)

Materials required m ISE reference cartridge

m Lint-free gauze pads
m Tweezers

a To replace the ISE reference cartridge

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

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Operator’s Manual · Version 1.0 C-101
14 Maintenance of the analyzer cobas c 311 analyzer
Every six months maintenance

4
3

Figure C-51 Removing ISE covers and disconnecting the reference electrode wire

3 Remove the sipper cover and the cover of the ISE measuring compartment.
4 Disconnect the electrode wire of the ISE reference cartridge.

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cobas c 311 analyzer 14 Maintenance of the analyzer
Every six months maintenance

6
6

Figure C-52 Removing the ISE reference cartridge and wiping up spilled liquid

5 Pull the release lever toward the RELEASE position to loosen the cartridges from
the mounting block.
6 Use tweezers to remove the reference cartridge from the mounting block.
7 During the replacement:
o Thoroughly wipe up any spilled liquid or liquid adhering to connecting parts.
Remaining liquid on ion selective electrodes may lower measurement
precision.
o If an O-Ring from the cartridges is remaining inside the ISE measuring
compartment, use tweezers to remove it.
8 Insert the new ISE reference cartridge into the ISE measuring compartment while
holding the lever at RELEASE.

Verify that the connecting part and the new cartridge is provided with O rings, but be sure
to remove the black rubber protectors that are located over the O-ring receptacles on the
cartridge.

9 Set the lever at LOCK to fasten the cartridge, then reconnect the wire to the
cartridge.
10 Replace the sipper cover and the cover of the ISE measuring compartment.

Incorrect results due to missing covers of the ISE unit

If the cover of the ISE measuring compartment or the cover of the sipper nozzle are not
CAUTION reinstalled after maintenance, the temperature level or the noise level may be affected,
leading to incorrect results.
Always reinstall the covers of the ISE unit after performing maintenance.

11 Go through the following procedures before you resume routine operation. Select
the REF option for the reagent prime.
e See: To prime lines on page C-77
To perform an ISE Check and calibrate the ISE unit on page C-77

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Operator’s Manual · Version 1.0 C-103
14 Maintenance of the analyzer cobas c 311 analyzer
As needed maintenance

As needed maintenance

In this section you will find all the maintenance actions that must be performed as
needed and are not subject to a regular time schedule.
e This section discusses the following maintenance actions:
M23: Replacing sample and reagent probes—elimination of clogging on page C-104
M24: Replacing nozzle tips on cell rinse nozzles on page C-113
M25: Draining the vacuum tank on page C-115

M23: Replacing sample and reagent probes—elimination of clogging

It is necessary to remove a probe to clean its inside, eliminate clogging, as well as for
replacement. Replace the sample, ISE or reagent probes when they are bent or
otherwise damaged.
This maintenance action comprises the following procedures:
1. To wash the sample probe
2. To remove the sample probe
3. To remove the reagent probe
4. To eliminate clogging
5. To put back the sample probe
6. To put back the reagent probe
7. To check the tubing system for leakage
8. To perform an air purge and check the operation of the probe
9. To perform a Mechanisms Check
Operator time: approximately 7 minutes
System time: approximately 12 minutes

Materials required m Sample cleaner 1 (Multiclean): approximately 300 µL (in case the sample probe is
to be washed)
m Sample or reagent probe (in case replacement is required)
m Sample probe seal (in case it has been pulled-off and the probe is not replaced)
m Cleaning wire (stainless steel) of 0.2 and 0.5 mm diameter
m Deionized water

Before performing these maintenance actions, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8
o Infection and injury due to contact with instrument mechanism on page C-3
o Infection and injury due to sharp objects on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on page A-9

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C-104 Operator’s Manual · Version 1.0
cobas c 311 analyzer 14 Maintenance of the analyzer
As needed maintenance

a To wash the sample probe

This procedure can be used to wash a clogged sample probe.
1 Put the analyzer in Standby.
2 Choose Utility > Maintenance.
3 Select Maintenance (1) from the Maintenance Type list on the left.
4 Select (11) Sample Probe Wash from the Maintenance Items list on the right.
5 Choose Select to open the Sample Probe Wash window.
6 Specify a number of cycles for washing in the Cycles input box (5 cycles are
recommended).
7 Choose Execute.
The inside of the sample probe is cleaned with sample cleaner 1 (Multiclean).

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14 Maintenance of the analyzer cobas c 311 analyzer
As needed maintenance

a To remove the sample probe

1 Shut down the analyzer. (In Maintenance mode, the liquid level sensor would be
electrified.)
2 Unlock and open the top cover of the analyzer.

5
4

A Probe seal

Figure C-53 Removing the sample probe

3 Remove the pipetter arm cover by pressing the arm cover releases—located on
either side of the fixed bottom part of the pipetter arm—and gently lift up the
cover. This exposes the wires and the tubing.
4 Disconnect the wire of the liquid level sensor.
5 Loosen the tubing from the probe by unscrewing it, taking care not to drop and
lose the probe seal (A). Check that the probe seal stays either on the end of the
probe tubing or in the retaining nut.
6 Lift the probe from the probe arm.

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C-106 Operator’s Manual · Version 1.0
cobas c 311 analyzer 14 Maintenance of the analyzer
As needed maintenance

a To remove the reagent probe

Figure C-54 Removing the reagent probe

1 Disconnect the tube connector of the reagent tubing.

2 Loosen the probe retaining nut by turning it counterclockwise.
3 Lift the probe from the probe arm.

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Operator’s Manual · Version 1.0 C-107
14 Maintenance of the analyzer cobas c 311 analyzer
As needed maintenance

a To eliminate clogging

Sample probe Reagent probe

Figure C-55 Eliminate clogging from the probes

1 To eliminate clogging use probe cleaning wire (stainless steel) with the following
diameters:
o For the sample probe: 0.2 mm diameter
o For the reagent probe: 0.5 mm diameter
2 Insert the probe cleaning wire into the probe tip and run it through the probe.
3 Rinse the inside of the probe thoroughly with deionized water, then wipe the
probe with clean lint-free gauze pads.

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cobas c 311 analyzer 14 Maintenance of the analyzer
As needed maintenance

a To put back the sample probe

1 To put the sample probe back in place, follow the instructions in the note below
and the instructions for removing in the reverse order.

Observe the following when replacing the sample probe:

o When replacing the probe into the pipetter arm, the tab (Figure C-56, C) must slide into
the holding slot on the pipetter arm to ensure proper alignment.
o Make sure that the tubing is inserted and held in the slit of the foam cushion (A).
o A probe seal (B), once pulled off, should not be reused since the edge will be
deformed. A new probe always comes with a new seal.
o Reconnect the tubing making sure the probe seal is in place.
o Do not replace the arm cover of the probes until the tubing has been checked for
leakage.

e For the instructions for removing, see:

To remove the sample probe on page C-106.

A B C

A Foam cushion with holding slit for tubing C Tab for aligning the pipetter in the pipetter
B Probe seal arm

Figure C-56 Putting back the sample probe

2 Check the tubing system for leakage.

e See To check the tubing system for leakage on page C-110

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Operator’s Manual · Version 1.0 C-109
14 Maintenance of the analyzer cobas c 311 analyzer
As needed maintenance

a To put back the reagent probe

1 To put the reagent probe back in place, follow the instructions for removing in the
reverse order.
e To remove the reagent probe on page C-107

2 Check the tubing system for leakage.

e See To check the tubing system for leakage on page C-110

a To check the tubing system for leakage

1 Close the top cover of the analyzer and lock it.
2 Switch on the analyzer.
3 After initialization, put the analyzer in Maintenance mode.
4 Unlock and open the top cover of the analyzer.
5 Check the tubing joints of the probes for leakage.
o Sample pipetter
O Visually check for any water leakage from the connecting parts (while arm
cover is detached).
o Reagent pipetter
O Visually check for any water leakage from the connecting parts.
6 If there is a leak, perform the following:
o Close the top cover and turn the maintenance switch back to Operation mode.
o Shut down the analyzer temporarily.
o Wipe up the leaked water.
o Check for the cause and eliminate any leaks.
o Repeat steps 1-5 to check for leakages again.
7 If there are no leaks, perform the following:
o Replace the arm cover of the sample pipetter, the rear part first and then the
front part.
o Close the top cover of the analyzer and lock it.
8 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
9 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
10 Go through the following procedures before you resume routine operation:
o To perform an air purge and check the operation of the probe
e To perform an air purge and check the operation of the probe on page C-111
o To perform a Mechanisms Check
e To perform a Mechanisms Check on page C-112

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cobas c 311 analyzer 14 Maintenance of the analyzer
As needed maintenance

a To perform an air purge and check the operation of the probe

1 Close the top cover of the analyzer and lock it.
2 Choose Utility > Maintenance.
3 Select Maintenance (1) from the Maintenance Type list on the left.
4 Select (5) Air Purge from the Maintenance Items list on the right.
5 Choose Select to open the Air Purge window.

Figure C-57 Air Purge window

6 In the Syringe area select the appropriate option (Sample Syringe, Reagent Syringe
or All).
7 Choose Execute to initiate the air purge.
The respective pipetter will operate (System time: 1:45). At the rinse station, water
as well as any air which may have become trapped are discharged.
8 With top cover closed, visually check that water is dispensed from the tip of the
probe in a straight flow.
If water is not dispensed in a straight flow, eliminate clogging of the probe.
e For more information, see:
M23: Replacing sample and reagent probes—elimination of clogging on page C-104.

Now, continue with the mechanisms check.

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Operator’s Manual · Version 1.0 C-111
14 Maintenance of the analyzer cobas c 311 analyzer
As needed maintenance

a To perform a Mechanisms Check

1 Close the top cover of the analyzer and lock it.
2 Choose Utility > Maintenance.
3 Select Check (2) from the Maintenance Type list on the left.
4 Select (3) Mechanisms Check from the Maintenance Items list on the right.
5 Choose Select to open the Mechanisms Check window.

Figure C-58 Mechanisms check window

6 Enter 30 at Cycles and choose Execute.

All mechanisms of the analyzer selected will operate (system time: 9:40).
After mechanisms check, the analyzer returns to Standby. If an error is detected, an
alarm will be issued.

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C-112 Operator’s Manual · Version 1.0
cobas c 311 analyzer 14 Maintenance of the analyzer
As needed maintenance

M24: Replacing nozzle tips on cell rinse nozzles

Replace the nozzle tips on the cell rinse nozzles if they are worn. The replacement
cycle is typically one to two years depending on conditions of use.
Replace a nozzle tip if its corner or bottom is worn so that water remains in the
reaction cell.
Operator time: approximately 6 minutes
System time: approximately 10 minutes

Materials required m Nozzle tips

m Radio pliers

Before performing this maintenance action, observe the following safety

precautions:
o Infection by samples and associated materials on page A-8

a To replace the cell rinse nozzle tips

1 Put the analyzer in Maintenance mode or Shutdown status.
2 Unlock and open the top cover of the analyzer.

Figure C-59 Dismounting the cell rinse unit and the nozzle tips

3 Loosen the retaining screw of the cell rinse unit and lift off the entire unit.

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14 Maintenance of the analyzer cobas c 311 analyzer
As needed maintenance

4 Grip the nozzle tip with radio pliers and pull it off.

A Correct alignment Incorrect alignment

7
A

A Guide bar

Figure C-60 Alignment of a nozzle tip in relation to reaction cells

5 Attach a new nozzle tip by hand and align it with the guide bars (A).
6 Attach the cell rinse unit.
7 Make sure that the new nozzle tip is correctly aligned with the reaction cell.
8 Close the top cover of the analyzer and lock it.
9 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status). The analyzer returns to Standby.
10 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
11 Perform maintenance check (3) Mechanisms Check (30 cycles).
e See To perform a Mechanisms Check on page C-112.

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cobas c 311 analyzer 14 Maintenance of the analyzer
As needed maintenance

M25: Draining the vacuum tank

At the end of analysis each day, we recommend checking the vacuum tank. An alarm
will be issued (Liquid in vacuum tank) when there is water or waste solution in the
vacuum tank. If this alarm appears, the vacuum tank must be drained. If this happens
frequently, contact your local service representative.
Operator time: approximately 5 minutes

Materials required m Beaker

Before performing this maintenance action, observe the following safety

precautions:
o Infection by waste solution on page A-9
o Contamination of the environment by waste solution and solid waste on page A-9

a To drain the vacuum tank

1 The analyzer can be either in Standby, Maintenance mode, or Shutdown status.
2 Open the front doors of the analyzer and locate the vacuum tank.

Figure C-61 Draining the vacuum tank

3 Remove the cap holding the drain tube of the vacuum tank.
4 Drain the waste solution into a beaker.
5 Reattach the cap to secure the drain tube.

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Operator’s Manual · Version 1.0 C-115
14 Maintenance of the analyzer cobas c 311 analyzer
As needed maintenance

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C-116 Operator’s Manual · Version 1.0
 Troubleshooting D

15 Data alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

16 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-43
cobas c 311 analyzer 15 Data alarms
Table of contents

Data alarms

This chapter contains the data alarms generated by the cobas c 311 analyzer. In
addition to a description of the cause of each alarm and remedy, the analytical unit of
origin and automatic rerun conditions are described here.

In this chapter Chapter 15

Introduction ............................................................................................................... D-7
Data alarm list ............................................................................................................ D-8
Data alarms (ISE unit) ............................................................................................... D-9
ADC.E ................................................................................................................... D-9
Calc.? ..................................................................................................................... D-9
Cal.E (Sample flag) ............................................................................................. D-10
ClcT.E .................................................................................................................. D-10
CmpT.? ................................................................................................................ D-10
CmpT.E ............................................................................................................... D-11
Edited .................................................................................................................. D-11
H (only on printouts) ........................................................................................ D-11
>Index ................................................................................................................. D-11
ISE.E .................................................................................................................... D-12
ISE.N ................................................................................................................... D-13
L (only on printouts) ......................................................................................... D-13
<Mix .................................................................................................................... D-14
Mix.E ................................................................................................................... D-14
Over.E .................................................................................................................. D-14
Reag.S .................................................................................................................. D-14
>Rept / <Rept ..................................................................................................... D-15
Samp.S ................................................................................................................. D-15
Samp.C ................................................................................................................ D-15
>Test .................................................................................................................... D-16
>Test / <Test ....................................................................................................... D-16
Data alarms (photometric unit) .............................................................................. D-17
>Abs .................................................................................................................... D-17
ADC.E ................................................................................................................. D-18
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15 Data alarms cobas c 311 analyzer
Table of contents

Calc.? ................................................................................................................... D-18

Cal.E (Sample flag) ............................................................................................. D-18
ClcT.E .................................................................................................................. D-18
CmpT.? ................................................................................................................ D-19
CmpT.E ............................................................................................................... D-19
>Cuvet ................................................................................................................. D-19
Det.S .................................................................................................................... D-20
Edited .................................................................................................................. D-20
H (only on printouts) ........................................................................................ D-20
>Index ................................................................................................................. D-20
>Kin .................................................................................................................... D-21
>Lin ..................................................................................................................... D-21
L (only on printouts) ......................................................................................... D-21
Mix.E ................................................................................................................... D-22
<Mix .................................................................................................................... D-22
Over.E .................................................................................................................. D-22
>Proz ................................................................................................................... D-22
>React ................................................................................................................. D-23
ReagEx ................................................................................................................. D-23
>Rept / <Rept ..................................................................................................... D-23
Samp.? ................................................................................................................. D-24
Samp.C ................................................................................................................ D-24
Samp.S ................................................................................................................. D-24
>Test / <Test ....................................................................................................... D-24
Alarms for calibrations ............................................................................................ D-25
Cal.E (Calib flag) ................................................................................................ D-25
Cond.E ................................................................................................................ D-26
Dup.E .................................................................................................................. D-27
IStd.E ................................................................................................................... D-28
Prep.E .................................................................................................................. D-29
Rsp1.E ................................................................................................................. D-29
Rsp2.E ................................................................................................................. D-30
S1A.E ................................................................................................................... D-30
SD.E ..................................................................................................................... D-31
Sens.E .................................................................................................................. D-31
Slop.E .................................................................................................................. D-32
Std.E .................................................................................................................... D-33
Data alarms for controls .......................................................................................... D-34
Q3SD ................................................................................................................... D-34
Q2.5SD ................................................................................................................ D-35
R4SD ................................................................................................................... D-35
S2-2Sa .................................................................................................................. D-35
S2-2Sw ................................................................................................................. D-36
S4-1Sa .................................................................................................................. D-36
S4-1Sw ................................................................................................................. D-37
S10Xa .................................................................................................................. D-37
S10Xw ................................................................................................................. D-37
Data problems without alarm ................................................................................. D-38
Drift of result data .............................................................................................. D-38
Erroneous operation .......................................................................................... D-38

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D-4 Operator’s Manual · Version 1.0
cobas c 311 analyzer 15 Data alarms
Table of contents

Poor reproducibility ........................................................................................... D-38

Result data at high level ...................................................................................... D-39
Result data at low level ....................................................................................... D-39
Trouble attributed to characteristics of reagent ................................................ D-40
Trouble with a test .............................................................................................. D-40
Rerun list ................................................................................................................... D-41

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15 Data alarms cobas c 311 analyzer
Table of contents

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cobas c 311 analyzer 15 Data alarms
Introduction

Introduction

If any abnormality occurs while the analyzer is switched on, the analyzer notifies the
operator of the potential problem by issuing an alarm. These alarms comprise data
alarms (referring to irregular measurement results or conditions) and instrument
alarms (referring to irregular system conditions). Alarms are classified into five levels:

Alarm levels Data alarm This alarm is attached to the results of calibrations or to measurement
results of QC or patient samples. If a data alarm occurs at calibration or
QC sample measurement and if it will affect subsequent measurements,
an instrument alarm of the warning level occurs at the same time. The
analyzer does not stop operation.
Warning This alarm is generated by data alarms or troubles on the instrument. If
this alarm occurs during operation, the analyzer does not stop operation.
The operator must judge whether to continue or interrupt measurement.
Sampling stop This alarm concerns troubles on the instrument. For the pipetted sample,
measurement is continued. The analyzer stops pipetting new samples.
Stop This alarm concerns troubles on the instrument. The analyzer stops
operation within one cycle (12 seconds). For the sample under
measurement, no result data are obtained and the measurement must be
repeated.
Emergency stop This alarm concerns troubles on the instrument. The analyzer
immediately stops operation. For the samples under measurement, no
result data are obtained and the measurement must be repeated.

Alarm indication Data alarms are indicated on the Workplace > Data Review screen, on the Test Review
window (Workplace > Data Review > Test Review), on printed reports, and are sent
to Host. If a data alarm occurs, a symbol (also referred to as flag) is attached to the
measurement result. These flags are strings of three to six characters, which are all
explained in this chapter.

Instrument alarms are indicated by the Alarm button (global button) on the System
Overview screen as well as by an audible alarm. If an alarm occurs, the Alarm button
flashes. Its color indicates the alarm level: Yellow indicates warning level, red indicates
sampling stop, stop, or emergency stop.
In case of an alarm choose the Alarm button to open the Alarm window. This window
provides an alarm list and descriptions and remedies for each listed alarm.

Automatic rerun If a data alarm occurs on a test for which automatic rerun is selected (check box on
Utility > Application > Range), a rerun is automatically requested. For execution of
the automatic rerun during measurement, however, automatic rerun needs to be
activated on the Start Conditions screen as well.
For QC and patient samples, a data alarm consists of an alarm message and a result
message. The result messages are specific to the cobas c 311 analyzer tests.

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Data alarm list

Data alarm list

The following table displays the data alarms applicable to the ISE unit, the
photometric unit, and their presentation (flag) on screens and reports.

Flag Alarm ISE unit Photometric unit

>Abs ABS over – l
ADC.E ADC abnormal l l
Calc.? Calculation not possible l l
Cal.E (Sample flag) Calibration result abnormal (Sample flag) l l
ClcT.E Calculated test error l l
CmpT.? Unable to calculate compensated test l l
CmpT.E Data error in compensated test l l
>Cuvet Cell blank abnormal – l
Det.S Detergent short (carryover evasion) – l
Edited Edited test l l
H Outside of the upper expected value l l
>Index Serum index check l l
ISE.E ISE voltage level error l –
ISE.N ISE noise error l –
>Kin Prozone error 2 / Kinetic unstable – l
>Lin Linearity abnormal – l
L Outside of the lower expected value l l
Mix.E Ultrasonic mixing error l l
<Mix Mixing power low level l l
Over.E Overflow l l
>Proz Prozone error 1 – l
(a) l l
Q2.5SD 1-2.5SD (QC error 2)
(a) l l
Q3SD 1-3SD (QC error 1)
(a) l l
R4SD R-4S (Random error in realtime QC)
>React Reaction limit over (substrate depletion) – l
ReagEx Reagent expired – l
Reag.S Reagent short l –
>Rept / <Rept Repeat limit over (upper / lower) l l
(a)
S2-2Sa 2-2SA (Syst. error 1 - 2 results) l l
(a)
S2-2Sw 2-2SW (Syst. error 2 - 2 samples / 4 results) l l
(a)
S4-1Sa 4-1SA (Syst. error 3 - 4 results) l l
(a)
S4-1Sw 4-1SW (Syst. error 4 - 4 samples / 8 results) l l
(a)
S10Xa 10XA (Syst. error 5 - 10 results) l l
(a)
S10Xw 10XW (Syst. error 6 - 10 samples / 20 results) l l
Samp.? ABS maximum over (non-lin curve) – l
Samp.C Sample clot l l
Table D-1 Data alarm list (Sheet 1 of 2)
(a) QC alarms, see: Data alarms for controls on page D-34, Configuring and using realtime QC on page B-154.

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Data alarms (ISE unit)

Flag Alarm ISE unit Photometric unit

Samp.S Sample short l l
>Test ISE range over l –
>Test / <Test ISE sample range outside technical limit, l l
photometric unit: Upper/Lower technical Limit
Table D-1 Data alarm list (Sheet 2 of 2)
(a) QC alarms, see: Data alarms for controls on page D-34, Configuring and using realtime QC on page B-154.

Data alarms (ISE unit)

ADC.E

Alarm ADC abnormal

Description The analog/digital converter does not work normally.

Cause Numerical conversion of the electromotive force is abnormal.

Remedy 1 If other instrument alarm exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance and perform maintenance item (1) Reset. If the
alarm recurs call technical support.

Calc.?

Alarm Calculation not possible

Description The denominator becomes zero in calculation.

1 During calculation the denominator became zero.
2 An overflow occurred in logarithmic or exponential calculation.
3 Result was left blank.

Cause Internal calculation error has occurred.

Remedy 1 Check the test that is flagged with an error message in the calculation. Dilute the
sample and rerun the sample.
2 Check the calibration type list box on Utility > Application > Calib.
3 Resume operation. If alarm recurs, call technical support.

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Data alarms (ISE unit)

Cal.E (Sample flag)

Alarm Calibration result abnormal (Sample flag)

Description No calibration data or previous calibration data used.

Cal.E appears on each QC and patient sample for the affected test until the problem is
resolved.

Cause Any alarm, for example, Std.E, ISE.E, ISE.N, …, occurred during calibration.

Remedy 1 Correct the condition causing the alarm that occurred during the latest
calibration.
2 Recalibrate.

ClcT.E

Alarm Calculated test error

Description Calculation error has occurred.

Cause A data alarm has occurred for a test needed in the calculation. This is not valid for the
following errors and alarms:
o Calculation not possible (Calc.?)
o Unable to calculate compensated test (CmpT.?)

Remedy 1 Correct the data alarm of the test to be used on the calculation.
2 Recalibrate.

CmpT.?

Alarm Unable to calculate compensated test

Description During test-to-test compensation calculation, the denominator became zero. Blank
space is left in the report.

Cause o The test used for test-to-test compensation has not been measured yet.
o Any test used for test-to-test compensation has data alarm calculation not possible
(Calc.?) or data error in compensated test (CmpT.E).
o Any test used in the compensation formula has a data alarm that leaves the result
blank (for example, Samp.S, Reag.S).

Remedy 1 Correct the data alarm of the test to be used for compensation.
2 Rerun the sample.

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Data alarms (ISE unit)

CmpT.E

Alarm Data error in compensated test

Description 1 In test-to-test compensation calculation, a data alarm other than those shown
below is indicated for the compensation test data.
2 Calculation not possible, test-to-test compensation disabled, overflow.

Cause The test to be used for compensation has a data alarm.

Remedy Correct the data alarm on the test to be used for compensation. Rerun the sample.

Edited

Alarm Edited test

Description An edited first result or replaced rerun result is marked with an Edited alarm on the
Data Review screen. This also prints on the patient report.

Cause The result data has been edited.

Remedy Check the result of measurement.

H (only on printouts)

Alarm Outside of the upper expected value

Description For patient samples, the calculated concentration is greater than the upper limit of the
expected value range.
For control samples, a concentration exceeded the 2 SD values specified on QC >
Install.

Cause o The sample concentration is higher than the expected value.

o A proper expected value range is not specified.

Remedy Follow laboratory protocol for high samples.

This alarm does NOT cause an incomplete sample status alarm.

>Index

Alarm Serum index check

Description In one or more tests, the L, H, I value is larger than the specified reference value.

Cause A highly lipemic, hemolytic, or icteric sample has been measured.

Remedy Check the result of measurement.

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Data alarms (ISE unit)

ISE.E

Alarm ISE voltage level error

Description During measurement of internal reference, the EMF was not within the following
ranges (Internal standard solution):

Na+ -90.0 to -10 mV

K+ -90.0 to -10 mV
Cl– 80.0 to 160 mV

Cause o The reference electrode is deteriorated.

o Insulation is poor due to liquid leakage from the reference electrode mounting
section.
o The internal standard solution (ISE IS) is not set properly.

Remedy 1 Set the reagent and perform maintenance item (7) Reagent Prime for the ISE unit
(IS+REF).
2 Replace the electrode and perform maintenance item (7) Reagent Prime for the
ISE unit (IS+REF).
3 Make sure that the O-ring is attached to the electrode joint and then perform
maintenance item (7) Reagent Prime for the ISE unit (IS+REF).
4 Set the internal standard solution (ISE IS) properly and perform maintenance
item (7) Reagent Prime for the ISE unit (IS+REF).
5 Connect the cord correctly.

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Data alarms (ISE unit)

ISE.N

Alarm ISE noise error

Description In ISE measurement, the fluctuation in electromotive force exceeds the following
value:

Na+ 0.7 mV
K+ 1.0 mV
Cl– 0.8 mV

Cause o Entry of air bubbles because of lack of reagent

o Entry of air bubbles due to improper attachment of electrode
o Entry of air bubbles through sipper tube
o Poor insulation of waste solution drain port
o Poor insulation due to liquid leakage from sipper pipetter
o Missing covers of the ISE unit

Remedy 1 Check for sufficient reagent volume, make sure the tubing sits correctly in the
ISE Ref. bottle, and perform maintenance item (7) Reagent Prime for the ISE unit
(IS + REF).
2 Make sure that the O-ring is attached to the electrode joint and perform
maintenance item (7) Reagent Prime for the ISE unit (IS + REF).
3 Replace the sipper tube and perform maintenance item (7) Reagent Prime for the
ISE unit (IS + REF).
4 Eliminate deposits.
5 Carry out cleaning, checkup, and maintenance of the sipper syringe.
6 Make sure that the ISE compartment cover and the cover of the ISE sipper are
reinstalled after maintenance.

L (only on printouts)

Alarm Outside of the lower expected value

Description For patient samples, the calculated concentration is less than the lower limit of the
expected value range. For control samples, a concentration was less than the 2 SD
values entered on QC > Install.

Cause o The sample concentration is lower than the expected value.

o A proper expected value range is not specified.

Remedy Follow laboratory protocol for low samples.

This alarm does NOT cause an incomplete sample status alarm.

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Data alarms (ISE unit)

<Mix

Alarm Mixing power low level

e Cause and remedy are identical to the data alarm of the photometric unit.
See <Mix on page D-22.

Mix.E

Alarm Ultrasonic mixing error

e Cause and remedy are identical to the data alarm of the photometric unit.
See Mix.E on page D-22.

Over.E

Alarm Overflow

Description Display is not possible because the output figure exceeds 6 digits

Cause o The data is obtained in more than six digits including a negative sign and decimal
point.

Remedy o Minimize the difference in concentration between the sample and calibrator.
o Obtain the result data with six characters including negative sign and decimal
point.

Reag.S

Alarm Reagent short

Description There is insufficient ISE reagent volume when alarm is associated with sodium,
potassium and chloride values.

Cause There is not enough reagent in the reagent bottle.

Remedy 1 Verify adequate reagent volumes. Replace low reagent, as necessary. Update the
new reagent volume manually. Prime new reagent and recalibrate.
2 If adequate reagent volumes are present, verify volumes on the Reagent screen.
Update the values manually, if necessary. Rerun the sample.
3 Resume operation. If alarm recurs, call technical support.

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Data alarms (ISE unit)

>Rept / <Rept

Alarm Repeat limit over (upper / lower)

Description The result falls outside the repeat limit range programmed on Utility > Application >
Range.

Cause The sample concentration is higher (>Rept) or lower (<Rept) than the set value.

Remedy This alarm can be activated on Utility > System (Page 1/5) > Alarm. If activated, the
analyzer can also be programmed to automatically repeat this test with normal
sample volume.

Samp.S

Alarm Sample short

Description The liquid level cannot be detected in the sample container.

Cause 1 The sample volume is insufficient in the sample container.

2 The sample probe wire is disconnected.

Remedy 1 Add sample and rerun.

2 If alarm recurs, check sample probe alignment and sample probe wire
connections.
3 Resume operation. If alarm recurs, call technical support.

Samp.C

Alarm Sample clot

Description The specified volume of sample is not aspirated.

Cause A clot is detected.

Remedy 1 Perform maintenance procedure To wash the sample probe on page C-105.
2 If alarm recurs, remove the sample probe, clean it manually, and eliminate clog. If
a probe is bent or damaged, replace it with a new one.
e See M23: Replacing sample and reagent probes—elimination of clogging on page C-104

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Data alarms (ISE unit)

>Test

Alarm ISE range over

Description If the data is out of following ranges, ISE range over is issued.

Na+ 10-250 mmol/L

K+ 1-100 mmol/L
Cl– 10-250 mmol/L

Cause o The electrode is deteriorated.

o The flow path is contaminated.

Remedy 1 Are controls in range?

If Yes, go to 2.
If No, go to 3.
2 Continue with routine analysis. Continue with step 3 at the end of the day.
3 Replace the appropriate cartridge according to the procedure in the Maintenance
Guide.
e See M14: Replacing ISE measuring cartridges (Cl, K, Na) on page C-74.

4 Resume operation.
If alarm recurs, call technical support.

>Test / <Test

Alarm ISE sample range outside technical limit

Description The measured value is outside the technical limit range entered on Utility >
Application > Range.
o Over the technical limit: Value is greater than the upper limit (>Test).
o Under the technical limit: Value is less than the lower limit (<Test).

Cause 1 The sample concentration is higher than the set value (>Test).
2 The sample concentration is lower than the set value (<Test).
3 An improper technical limit range is specified.

Remedy 1 Manually dilute and rerun the diluted sample until the measured concentration is
within the specified range. Be sure to calculate the original concentration from the
measured value, using the correct dilution factor.
In case of urine sample s with a <Test alarm, a manual rerun can be performed
with decreased volume (6.5 µL instead of normal volume).
2 Perform maintenance item (11) Sample Probe Wash.
3 Clean the sample probe manually.
4 Call technical support.

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Data alarms (photometric unit)

Data alarms (photometric unit)

>Abs

Alarm ABS over

Description The absorbance value to be used for calculation after cell blank correction exceeded
3.3.

Cause o The sample concentration is too high or the sample is lipemic.

o The reagent has not been prepared properly.
o Obstructions are in the optical path of the photometer.

Remedy o If only one sample is affected: Check whether the sample is grossly lipemic or has
an extremely high value. Follow your laboratory protocol for this situation.
o If only one application is affected: Check reagent preparation for that test.
o If all samples are affected:
O Remove any obstructions in the optical path of the photometer. Make sure the
lamp is on.
O Choose Utility > Maintenance and perform maintenance item (4) Incubation
Water Exchange
O Clean the incubator bath if it is contaminated.
e For further instructions, see:
M9: Replacing reaction cells and cleaning incubator bath on page C-62.
O Choose Utility > Maintenance and perform maintenance item (2) Photometer
Check.
O Check the Photometer Check results on the printout (Abs < 14000).
O Replace the photometer lamp, if necessary.
O Resume operation. If alarm recurs, call technical support.
o If all samples are affected sporadically:
O Check if some reaction cells are scratched. Replace all cells if necessary.
e For further instructions, see:
M9: Replacing reaction cells and cleaning incubator bath on page C-62

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Data alarms (photometric unit)

ADC.E

Alarm ADC abnormal

Description The analog-digital converter does not work normally.

Cause 1 Numerical conversion is abnormal.

2 The cell count is abnormal.

Remedy 1 If other instrument alarms exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance and perform maintenance item (1) Reset.
3 If the alarm recurs, remove the reaction disk and check for water droplets or dust
on sensors. Clean if necessary.
4 If the alarm recurs call technical support.

Calc.?

Alarm Calculation not possible

Description The denominator becomes zero in calculation.

e Cause and remedy are identical to the data alarm of the ISE unit.
See Calc.? on page D-9.

Cal.E (Sample flag)

Alarm Calibration result abnormal (Sample flag)

Description No calibration data or previous calibration data used.

Cal.E appears on each QC and patient sample for the affected test until the problem is
resolved.

Cause Any alarm (for example, Std.E) occurred during calibration.

Remedy 1 Correct the condition causing the alarm that occurred during the latest
calibration.
2 Recalibrate.

ClcT.E

Alarm Calculated test error

Description Calculation error has occurred.

e Cause and remedy are identical to the data alarm of the ISE unit.
See ClcT.E on page D-10.

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Data alarms (photometric unit)

CmpT.?

Alarm Unable to calculate compensated test

Description During test-to-test compensation calculation, the denominator became zero. Blank
space is left in the report.
e Cause and remedy are identical to the data alarm of the ISE unit.
See CmpT.? on page D-10.

CmpT.E

Alarm Unable to calculate compensated test

Description 1 In test-to-test compensation calculation, a data alarm for other than those shown
below is indicated for the compensation test data.
2 Calculation not possible (Calc.?), data error in compensated test (CmpT.E),
overflow (Over.E), random error (R4SD), systematic error (S2-2Sa, S2-2Sw, S4-
1Sa, S4-1Sw, S10Xa, S10Xw), QC error (Q2.5SD, Q3SD), and outside of expected
value (H/L only on the printout).
e Cause and remedy are identical to the data alarm of the ISE unit.
See CmpT.E on page D-11.

>Cuvet

Alarm Cell blank abnormal

Description The cell blank value used for measurement exceeds the reference value by more than
0.1Abs.

Cause Reaction cells are contaminated or damaged.

Remedy 1 Check that the reaction cell is not contaminated or cracked.

2 Choose Utility > Maintenance and perform maintenance item (6) Wash Reaction
Parts.
3 Check that there is no excessive foaming or particles in the incubator bath. If you
notice excessive foaming or particles, perform maintenance item (4) Incubation
Water Exchange.
4 Wipe the outside of the reaction cells with a gauze pad moistened with incubator
bath water. Perform maintenance item (4) Incubation Water Exchange.
5 Resume operation. If alarm recurs, ensure there is adequate rinse water and cell
blank water from the rinse mechanism. The cells must be completely filled.
6 Resume operation. If alarm recurs, choose Utility > Maintenance and perform
maintenance item (3) Cell Blank Measurement.
If the results for the first cell are greater than 14000 or if the deviation of the cells is
± 1000 or more, replace the cells and repeat the cell blank measurement.
e For further instructions, see:
M9: Replacing reaction cells and cleaning incubator bath on page C-62.

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Data alarms (photometric unit)

7 Resume operation. If alarm recurs, call technical support.

Det.S

Alarm Detergent short (carryover evasion)

Description If a special wash for the reagent probe is defined, the reagent probe plunges into the
cobas c pack with the specified detergent. This alarm occurs, if the test is carried out
even though the detergent volume is insufficient.

Cause The residual volume of the special wash detergent is insufficient.

Remedy 1 Load a new cobas c pack with the specified detergent.

2 Check the results of the measurement and rerun the sample if necessary.

Edited

Alarm Edited test

Description An edited first result or replaced rerun result is marked with an Edited alarm on the
Data Review screen. This also prints on the patient report.

Cause The result data has been edited.

Remedy Check the result of measurement.

H (only on printouts)

Alarm Outside of the upper expected value

e Description, cause, and remedy are identical to the data alarm of the ISE unit.
See H (only on printouts) on page D-11.

>Index

Alarm Serum index check

Description In one or more tests, the L, H, I value is larger than the specified reference value.

Cause A highly lipemic, hemolytic, or icteric sample has been measured.

Remedy Check the result of measurement.

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Data alarms (photometric unit)

>Kin

Alarm Prozone error 2 / Kinetic unstable

Description The prozone check value exceeds the specified limit value. (Reaction rate method)

Cause o The sample concentration is too high.

o The limit value is not set properly.

Remedy 1 Dilute and rerun the sample or rerun the sample with a decreased sample volume.
2 To avoid check, set [0] [0] [0] [0] [0] [0] [Inside] [0] [0] for Prozone Limit (on
Utility > Application > Analyze).

>Lin

Alarm Linearity abnormal

Description In a rate assay, the reaction linearity exceeds the specified limit value.

Cause o The photometer lamp is deteriorated.

o The linearity check value is not set properly.
o The sample is extremely lipemic.
o The ultrasonic mixers are defective.
o Debris are in the incubation bath.

Remedy 1 Check the photometer lamp.

2 Dilute and rerun the sample.
3 Choose Utility > Application > Analyze to check the Linearity Limit.
4 Choose Utility > Maintenance > Check (on Maintenance Type list) and perform
maintenance check (6) Cuvette Mixing to check the ultrasonic mixing
mechanisms.
5 Ensure the incubator bath is free of debris. Clean the incubator bath, if necessary.
e See M9: Replacing reaction cells and cleaning incubator bath on page C-62.

6 Resume operation. If alarm recurs, call technical support.

L (only on printouts)

Alarm Outside of the lower expected value

e Description, cause, and remedy are identical to the data alarm of the ISE unit.
See L (only on printouts) on page D-13.

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Data alarms (photometric unit)

Mix.E

Alarm Ultrasonic mixing error

Description There is no ultrasonic output for mixing.

Cause o The water level in the incubator bath is too low.

o The water level sensor of the incubator bath is abnormal.

Remedy Supply water to the incubator bath.

<Mix

Alarm Mixing power low level

Description The ultrasonic monitor value is lower than the reference value.

Cause The ultrasonic mixer is deteriorated.

Remedy 1 Clean the surface of the ultrasonic mixers.

e See M15: Cleaning the ultrasonic mixer on page C-79.

2 Call technical support.

Over.E

Alarm Overflow

Description Display is not possible because the output figure exceeds 6 digits

Cause o The K factor has more than six digits due to the use of a wrong calibrator.
o The data is obtained in more than six digits including a negative sign and decimal
point.

Remedy o Minimize the difference in concentration between the sample and calibrator.
o Obtain the result data with six characters including negative sign and decimal
point.

>Proz

Alarm Prozone error 1

Description The prozone check value exceeds the specified limit value. (Antigen readdition
method)

Cause o The sample concentration is too high for immunological test.

o The limit value is not set properly.

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Data alarms (photometric unit)

Remedy 1 Check the reagent preparation.

2 Dilute and rerun the sample or rerun the sample with decreased sample volume.
3 Choose Utility > Application > Analyze to check the upper prozone limit.
4 Resume operation. If the alarm recurs, call technical support.

>React

Alarm Reaction limit over (substrate depletion)

Description In a rate assay, main wavelength absorbance exceeds the specified limit value.

Cause o The sample concentration is too high.

o The reagent has been prepared improperly or is deteriorated.
o On Utility > Application > Analyze there is an improper setting in the Increase/
Decrease box in the Abs. Limit line.

Remedy 1 Verify the setting in the Increase/Decrease box on Utility > Application > Analyze.
2 Dilute and rerun the sample or rerun the sample with a decreased sample volume.
3 Prepare the reagent newly.

ReagEx

Alarm Reagent expired

Description The alarm indicates that an expired reagent was used; the test result is not guaranteed.
The alarm can be inactivated under Utility > Application > Alarm.

Cause The analyzer detected an expired reagent on board.

Remedy 1 Expired reagents are listed on the reagent unload list with the ReagEx alarm.
2 Exchange expired reagents.

>Rept / <Rept

Alarm Repeat limit over (upper / lower)

Description The result falls outside the repeat limit range programmed on Utility > Application >
Range.
e Cause and remedy are identical to the data alarm of the ISE unit.
See >Rept / <Rept on page D-15.

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Data alarms (photometric unit)

Samp.?

Alarm ABS maximum over (non-lin curve)

Description The absorbance of a sample is found equal or greater than the theoretical maximum
absorbance (for infinite analyte concentration). The result field will be left blank on
the report and Data Review screen. This blank result is transmitted, together with the
alarm code “>” to the Host.

Cause The sample concentration is too high.

Remedy Dilute the sample, if required, and rerun. If automatic rerun is programmed, the
sample will be rerun with a decreased sample volume.

Samp.C

Alarm Sample clot

Description The specified volume of sample is not aspirated.

e Cause and remedy are identical to the data alarm of the ISE unit.
See Samp.C on page D-15.

Samp.S

Alarm Sample short

Description The liquid level cannot be detected in the sample container.

e Cause and remedy are identical to the data alarm of the ISE unit.
See Samp.S on page D-15.

>Test / <Test

Alarm Upper/Lower technical Limit

Description The measured value is outside the technical limit range entered on Utility >
Application > Range.
e Cause and remedy are identical to the data alarm of the ISE unit.
See >Test / <Test on page D-16.

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Alarms for calibrations

Alarms for calibrations

The following table displays all calibration data alarms applicable to ISE tests,
photometric tests, and their presentation (flag) on screens and reports.

Flag Alarm ISE unit Photometric unit

Cal.E (Calib flag) CALIB error (Calib flag) l l
Cond.E Conditioning (ISE) abnormal l –
Dup.E Duplicate error – l
IStd.E Internal standard concentration abnormal l –
Prep.E Preparation abnormal l –
Rsp1.E Response (ISE) abnormal 1 l –
Rsp2.E Response (ISE) abnormal 2 l –
S1A.E Standard solution 1 absorbance (S1Abs) abnormal – l
SD.E SD limit error – l
Sens.E Sensitivity error – l
Slop.E ISE slope abnormal l –
Std.E Standard error – l
Table D-2 List of data alarms for calibrations

Cal.E (Calib flag)

Alarm CALIB error (Calib flag)

Displayed in Calibration > Status > Calibration Trace.

Description The current ISE calibrator concentration value or slope value differs from the
previous one by more than the specified Compensated Limit. The Compensated
Limit is a limit for the difference | previous value – current value | expressed as
percentage of the average (previous value + current value)/2.

The Cal.E alarm is a warning only, not necessarily indicative of a problem with the
calibration. Check the test’s control recovery before accepting the new calibration result.

Cause o The ISE calibrators or ISE reagents are not placed in proper position.
o The ISE reagents have deteriorated or the ISE calibrators have become
concentrated due to evaporation.

Remedy o Correct any other instrument and/or data alarms.

o Check calibrators, reagents, and controls. If controls are in range, and calibrators
and reagents are acceptable, resume operation. Otherwise, correct abnormalities
and recalibrate.
o Check Compensated Limit on Utility > Application > Calib.

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Alarms for calibrations

Cond.E

Alarm Conditioning (ISE) abnormal

Description The slope value is 68.1 mV or greater for Na+ or K+ electrodes, or it is -68.1 mV or
less for the Cl– electrode. The conditioning is inadequate.

Na+, K+ Slop.E Prep.E (Normal range) Cond.E

+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV

Cl– Cond.E (Normal range) Prep.E Slop.E

- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV

Figure D-1 ISE data alarms and corresponding slope values (EMF values)

Cause o Conditioning of a new electrode is unsatisfactory.

o The concentration of the calibrators ISE Low [Std(1)] or ISE High [Std(2)] is
improper.

Remedy 1 Run 10 dummy samples of human serum.

2 Prepare fresh calibrators ISE Low [Std(1)], ISE High [Std(2)], and ISE Comp.
[Std (3)], place them onto the sample disk and recalibrate the ISEs.
For US only, ISE High (compensated) is used instead of ISE Comp.
3 Resume operation. If alarm recurs, call technical support.

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Alarms for calibrations

Dup.E

Alarm Duplicate error

Displayed in Calibration > Status > Calibration Trace.

Description The difference between the first and second measurement (absorbance) of a
calibrator is outside the specified range.
The following steps describe how a decision is made to flag a calibration for violating
the duplication limit.
1 The absorbance for a calibrator (N) is measured twice.
2 The % of error and absorbance error are calculated.
3 Is the absorbance error < Duplicate Limit Abs. that appears on Utility >
Application?
If no, go to step 5.
If yes, go to step 4.
4 Continue with result calculations. No Dup.E alarm is issued.
5 Is the % error < the % Duplicate Limit?
If no, go to step 6.
If yes, go to step 4.
6 Dup.E alarm is issued for this result.

Cause The difference between the first and second measurement (absorbance) of a
calibrator is greater than Duplicate Limit Abs and greater than the % Duplicate Error.

Remedy 1 Recalibrate.
2 Check reagent preparation and expiration date. Prepare new reagent if necessary
and recalibrate.
3 If alarm recurs, call technical support.

If this alarm occurs, a Std.E alarm is issued. The Std.E alarm prevents updating of
calibration for the affected test.

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Alarms for calibrations

IStd.E

Alarm Internal standard concentration abnormal

Displayed on Calibration > Status > Calib Trace

Description The concentration of the Internal Standard solution (ISE IS) was not within the
following ranges:

Na+ 120.0-160.0 mmol/L

+
K 3.0-7.0 mmol/L
–
Cl 80.0-120.0 mmol/L

Cause o The flow path is contaminated.

o The reagent has deteriorated.

Remedy 1 If the EMF of ISE IS is abnormal on the calibration report, check the ISE IS
reagent volume and preparation. If necessary, prepare fresh reagent, prime and
recalibrate.
2 If the EMF of ISE IS is normal on the calibration report, check ISE reagent
syringe. The EMF of ISE IS lies ideally midway between the low and the high
standard. The ideal ISE IS concentrations values are: Na+: 140 mmol/L; K+:
5 mmol/L; Cl–: 100 mmol/L.
3 Resume operation. If alarm recurs, call technical support.
4 Perform maintenance item (10) ISE Wash to wash the flow path of the ISE unit.
e See M1: Washing ISE flow path and sample probe on page C-40

5 Replace the diluent and internal standard solution.

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Alarms for calibrations

Prep.E

Alarm Preparation abnormal

Displayed on Calibration > Status > Calib Trace.

Description The slope value is within the following range: 45.0 to 49.9 mV for Na+ or K+
electrodes, -39.9 to -35.0 mV for the Cl– electrodes.

Na+, K+ Slop.E Prep.E (Normal range) Cond.E

+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV

Cl– Cond.E (Normal range) Prep.E Slop.E

- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV

Figure D-2 ISE data alarms and corresponding slope values (EMF values)

Cause o The flow path is contaminated.

o The electrode is deteriorated.

Remedy 1 Perform maintenance item (10) ISE Wash to wash the flow path of the ISE unit.
e See M1: Washing ISE flow path and sample probe on page C-40

2 Replace the electrode.

Rsp1.E

Alarm Response (ISE) abnormal 1

Description The A Factor (response compensation factor) is outside the following limits:

Na+ A > 0.154

K+ A > 0.107
Cl– A > 0.330

Cause o The flow path is contaminated.

o The electrode is contaminated or deteriorated.

Remedy 1 Check ISE controls for correct levels.

2 If incorrect, go to step 3 before continuing routine analysis. If correct, go to step 3
after finishing routine analysis at the end of the day.
3 Perform maintenance item (10) ISE Wash to wash the flow path of the ISE unit.
e See M1: Washing ISE flow path and sample probe on page C-40

4 Run 10 dummy samples of human serum.

5 Prepare fresh calibrators, place them onto the sample disk and recalibrate the ISEs.
6 Resume operation. If alarm recurs, repeat steps 3 through 5 a maximum of two
times. If alarm recurs, replace the ISE cartridges.

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Alarms for calibrations

Rsp2.E

Alarm Response (ISE) abnormal 2

Description The A Factor is outside the following limits:

Na+ A > 0.232

K+ A > 0.160
Cl– A > 0.490

Cause o The flow path is contaminated.

o The electrode is contaminated or deteriorated.

Remedy e See Rsp1.E on page D-29.

S1A.E

Alarm Standard solution 1 absorbance (S1Abs) abnormal

Displayed in Calibration > Status > Calibration Trace.

Description During calibration, expected absorbance is outside the S1 Abs Limit. S1 is read
bichromatically for endpoint assays, monochromatically for rate assays.

Cause o The reagent has been prepared improperly or has deteriorated.

o An improper absorbance range is specified for calibrator 1.

Remedy 1 Check reagent preparation and calibration.

2 Recalibrate.
3 Check S1 Abs. Limit values on Utility > Application > Calib.
4 Resume operation. If alarm recurs, call technical support.

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Alarms for calibrations

SD.E

Alarm SD limit error

Description During nonlinear or multipoint linear calibration, the SD value was larger than the
SD limit programmed on Utility > Application.

The result of the calibration is updated.

Cause o The calibrator is not placed at the correct position.

o An improper SD limit value is specified.

Remedy 1 Check calibrator positions on Calibration > Calib.

2 Choose Utility > Application > Calib. to check the SD limit.
3 Check preparation and expiration dates of calibrators and reagents. Recalibrate
the affected test.
4 Check the standard concentrations on Calibration > Install. For a calibration with
automatic standard dilution; check whether the ratio between concentration,
sample, diluent volume and diluted sample is correct on Utility > Application >
Others.
5 Resume operation. If alarm recurs, call technical support.

Sens.E

Alarm Sensitivity error

Description Sensitivity is checked for linear (2 to 6 points), nonlinear, or isozyme-P calibration.

This alarm is indicated if the sensitivity value obtained in a calibration falls out of the
sensitivity limits specified on Utility > Application > Calib.
A sensitivity value is calculated from the measured absorbance values ( Abs ) and
given concentration values ( Conc ) of the blank calibrator ( S1 ) and the calibrator
SN :

Abs ( S N ) – Abs ( S 1 ) ⁄ Conc ( S N ) – Conc ( S 1 ) , where

S N = Std 2 for 2 Point calibrations and span calibrator for multipoint calibrations

For span calibration, the previous S1 Abs (linear) or previous mean absorbance (nonlinear)
of calibrator (1) is used for the sensitivity check.

Cause o An improper sensitivity limit is specified.

o The calibrator or reagent is not placed at a proper position.
o The reagent has been prepared improperly or has deteriorated.

Remedy 1 Check preparation and expiration dates of calibrators and reagents. Recalibrate
the affected test.
2 Check sample pipetter for leaks and recalibrate the affected test.
3 Choose Utility > Application > Calib. to check the sensitivity limit and recalibrate
the affected test.
4 Resume operation. If alarm recurs, call technical support.
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Alarms for calibrations

Slop.E

Alarm ISE slope abnormal

Displayed on Calibration > Status > Calib Trace.

Description The slope value is less than 45.0 mV for Na+ or K+ electrodes, or
greater than -35 mV for the Cl– electrode.

Na+, K+ Slop.E Prep.E (Normal range) Cond.E

+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV

Cl– Cond.E (Normal range) Prep.E Slop.E

- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV

Figure D-3 ISE data alarms and corresponding slope values (EMF values)

Cause o The electrode is deteriorated.

o The calibrators ISE Low [Std(1)] or ISE High [Std(2)] are not placed in the proper
positions.
o The sample probe is clogged.

Remedy 1 Replace the appropriate ISE cartridge before continuing routine analysis.
e See M14: Replacing ISE measuring cartridges (Cl, K, Na) on page C-74.

2 Run 10 dummy samples of human serum.

3 Prepare fresh calibrators; place them onto the sample disk and recalibrate the ISEs.
4 Resume operation. If alarm recurs, call technical support.

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Alarms for calibrations

Std.E

Alarm Standard error

Description 1 During photometric calibration, any one of the following alarms was
encountered:

Data alarm Data alarm

ABS over (absorbance exceeds 3.0) >Abs
ADC abnormal (analog/digital converter) ADC.E
Calculation not possible Calc.?
Cell blank abnormal >Cuvet
Duplicate error (difference between 1st and 2nd Dup.E
calibrator measurement)
Linearity abnormal (for rate assays) >Lin
Mixing power low level <Mix
Ultrasonic mixing error Mix.E
Reaction limit over (substrate depletion) >React
Reagent short Reag.S
Sample short Samp.S
Standard solution 1 absorbance (S1Abs) abnormal S1A.E
Table D-3 Data alarms giving rise to an Std.E alarm when occurring in calibration

2 During calibration, calculation was disabled.

3 During nonlinear calibration, an extreme value appeared.

The calibration is not updated if this alarm is issued; i.e. the prior calibration remains in
effect.

Cause o The reagent has not been prepared properly or is empty and has to be replaced.
o The concentration of calibrator is improper or the calibrator is not placed in the
proper position.
o An improper check value is specified.

Remedy 1 Correct any other instrument and/or data alarms.

2 Prepare fresh calibrators; place them onto the sample disk and recalibrate.
3 Replace reagent and recalibrate.
4 Choose Utility > Application to check the calibration parameters.
5 Resume operation. If alarm recurs, call technical support.

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Data alarms for controls

Data alarms for controls

Q3SD

Alarm 1-3SD (QC error 1)

Description In Realtime QC the control X or control Y data value is above 3 SD or below -3 SD.

Cause o The control is not properly prepared.

o The control is not properly positioned on the analyzer.
o The control is concentrated or deteriorated.
o Control values (mean value, standard deviation) are not correctly specified.
o The reagents are not properly prepared.
o Reagent is deteriorated (e.g., linearity of working curve degraded).
o Poor precision due to leakage of the pipetter joint.

This check is performed only when RULE 1-3 SD is selected (in QC Individual > Realtime
QC > Rules).

Remedy 1 Check that controls and reagents are properly prepared, positioned, and stored.
2 Check correct lot number and expiration dates of controls and reagents.
3 Check that the control values (mean value, standard deviation) are entered
correctly on QC > Install.
4 Prepare a new control and analyze it.
5 Prepare a new calibrator and perform a calibration.
6 Load a new cobas c pack or replace with a new cobas c pack.
7 Check the pipetter (Maintenance Check).
e See M23: Replacing sample and reagent probes—elimination of clogging on page C-104

8 Resume operation. If alarm recurs, call technical support.

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Data alarms for controls

Q2.5SD

Alarm 1-2.5SD (QC error 2)

Description In Realtime QC the control X value or control Y data value is above 2.5 SD or below
-2.5 SD.

This check is performed only when RULE 1-2.5SD is selected (in QC Individual > Realtime
QC > Rules).

e For cause and remedy description, see:

Q3SD on page D-34

R4SD

Alarm R-4S (Random error in realtime QC)

Description In Realtime QC one of X and Y data values is above 2 SD and the other is below -2 SD.

This check is performed only when RULE R-4SD is selected. N = run size entered on
Select Rules window (in QC Individual > Realtime QC > Rules).

e For cause and remedy description, see:

Q3SD on page D-34

S2-2Sa

Alarm 2-2SA (Syst. error 1 - 2 results)

Description In Realtime QC the control X and Y values are above 2 SD or below -2 SD.

This check is performed only when RULE 2-2SD is selected (in QC Individual > Realtime
QC > Rules).

e For cause and remedy description, see:

Q3SD on page D-34

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Data alarms for controls

S2-2Sw

Alarm 2-2SW (Syst. error 2 - 2 samples / 4 results)

Description In Realtime QC the last two control X or last two control Y values were above 2 SD or
below -2 SD.

Cause o Control values (mean value, standard deviation) are not correctly specified.
o The reagents are not properly prepared.
o Reagent is deteriorated (e.g., linearity of working curve degraded).
o Poor precision due to leakage of the pipetter joint.

This check is performed only when RULE 2-2SD is selected (in QC Individual > Realtime
QC > Rules).

Remedy 1 Check that the control values (mean value, standard deviation) are entered
correctly on QC > Install.
2 Check that reagents are properly prepared, positioned, and stored.
3 Check correct lot number and expiration dates of reagents.
4 Load a new cobas c pack or replace with a new cobas c pack.
5 Prepare a new calibrator and perform a calibration.
6 Prepare a new control and analyze it.
7 Check the pipetter (Maintenance Check).
e See M23: Replacing sample and reagent probes—elimination of clogging on page C-104

8 Resume operation. If alarm recurs, call technical support.

S4-1Sa

Alarm 4-1SA (Syst. error 3 - 4 results)

Description In Realtime QC the last two X and Y data values are above +1 SD or below -1 SD.

This check is performed only when RULE 4-1SD is selected (in QC Individual > Realtime
QC > Rules).

e For cause and remedy description, see:

S2-2Sw on page D-36

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Data alarms for controls

S4-1Sw

Alarm 4-1SW (Syst. error 4 - 4 samples / 8 results)

Description In Realtime QC the last four control X or last four control Y values are above 1 SD or
below -1 SD.

This check is performed only when RULE 4-1SD is selected (in QC Individual > Realtime
QC > Rules).

e For cause and remedy description, see:

S2-2Sw on page D-36

S10Xa

Alarm 10XA (Syst. error 5 - 10 results)

Description In Realtime QC the last five X and Y data values fall on the + or - side of the mean
value.

This check is performed only when RULE 10X is selected (in QC Individual > Realtime
QC > Rules).

e For cause and remedy description, see:

S2-2Sw on page D-36

S10Xw

Alarm 10XW (Syst. error 6 - 10 samples / 20 results)

Description In Realtime QC the last 10 control X or last 10 control Y values are positive-above the
mean value or negative-below the mean value.

This check is performed only when RULE 10X is selected (in QC Individual > Realtime
QC > Rules).

e For cause and remedy description, see:

S2-2Sw on page D-36

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15 Data alarms cobas c 311 analyzer
Data problems without alarm

Data problems without alarm

Drift of result data

Cause o Concentration or deterioration of sample.

o The calibrator is concentrated or deteriorated.
o The reagent flow path is contaminated (ISE unit).

Remedy 1 Avoid leaving the sample in the sample cup for a long time.
2 Perform maintenance item (10) ISE Wash to wash the flow path of the ISE unit.
e See M1: Washing ISE flow path and sample probe on page C-40

Erroneous operation

Cause o Neglect of preliminary or periodical check(s).

o Carryover between tests.
o Fibrin contained in sample or dust contained in reagent.
o The sample container that was used, was not recommended.

Remedy 1 Carry out preliminary and/or periodical check according to the specified
procedure.
2 Change the channel, use the wash program, or take any other measure after
consulting with the reagent manufacturer.
3 Eliminate fibrin or dust. Be sure to check the sample and reagent before setting
them.
4 Perform maintenance item (11) Sample Probe Wash.
5 Use the recommended sample container.

Poor reproducibility

Cause o A maintenance item is overdue.

o Deterioration of reagent or precipitation of insoluble matter.
o Deterioration of ISE reagents.
o Poor deionized water quality.
o Reagent handling was not done as recommended.
o Test parameters are not set properly.
o Air bubbles in the sample or reagent syringe (poor reproducibility).
o Liquid leakage from sample or reagent syringe (poor reproducibility).
o One of the ISE electrodes is contaminated or deteriorated (high value or low
value).

Remedy 1 Carry out daily checks and periodical maintenance according to the specified
maintenance procedure.
2 Replace with a new cobas c pack.

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Data problems without alarm

3 Replace with new ISE reagents. Do not add or mix old and new reagent.
4 The water quality must be 1 µS/cm (microsiemens per cm) or less.
5 Use the recommended reagent handling.
6 Check the completeness of the special wash list. If necessary, install the special
wash list according to the recommendation of the manufacturer.
7 Check for air bubbles and liquid leakage at the syringes.
o For sample syringe or reagent syringe perform an air purge (see To perform an
air purge (sample syringe or reagent syringe) on page C-90).
o For ISE sipper syringe perform a reagent prime (see To perform an air purge
(sample syringe or reagent syringe) on page C-90).
8 Perform maintenance item (10) ISE Wash to clean the ISE flow path or replace the
ISE measuring cartridges with new ones.
e See:
M14: Replacing ISE measuring cartridges (Cl, K, Na) on page C-74
M22: Replacing the ISE reference cartridge on page C-101

9 Call technical support.

Result data at high level

Cause o Concentration of control or sample.

o Deterioration of calibrator.
o Deterioration of ISE reagents.
o The reagent, control and calibrator handling was not done as recommended.

Remedy 1 Avoid leaving the sample or control in the sample cup for a long time.
2 Avoid leaving the calibrator in the sample cup open for a long time.
3 Replace with new ISE reagents. Do not add or mix old and new reagent.
4 Use the recommended reagent, control and calibrator handling.

Result data at low level

Cause o Concentration of calibrator.

o Reagent handling was not done as recommended.
o The test parameters are not set properly.
o Deterioration of ISE reagents.

Remedy 1 Use the calibrator immediately after opening the cap of the vial.
2 Prepare the reagent again by the correct method.
3 Set the concentration of calibrator, measuring wavelength, etc. properly.
4 Replace with new ISE reagents. Do not add or mix old and new reagent.

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15 Data alarms cobas c 311 analyzer
Data problems without alarm

Trouble attributed to characteristics of reagent

Cause o Cross contamination (high value, low value)

o Colored matter from the reagent or due to the reaction may adhere to the reaction
cell.

Remedy 1 Perform maintenance item (6) Wash Reaction Parts.

2 Check whether the special wash list is complete. Install the special wash list
according to the recommendations of the manufacturer.
e Special Wash on page B-209

Trouble with a test

Cause o Improper preparation or management of calibrator or control (high value, low

value).
o Improper management of reagent (low value).

Remedy 1 Prepare a new calibrator or control.

2 Replace with a new reagent.
3 Set the test parameters properly according to the setting table given by the reagent
manufacturer.

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cobas c 311 analyzer 15 Data alarms
Rerun list

Rerun list

The following table indicates whether a rerun is automatically requested by the

analyzer when a data alarm is attached to a result. The rerun conditions are displayed
under the ISE unit and photometric unit. The automatic rerun column indicates
whether a rerun is automatically requested by the analyzer.

Increase Sample is rerun at an increased sample volume

Normal Sample is rerun at same sample volume (repeat)
Decrease Sample is rerun at a decreased sample volume

Alarm ISE unit Photometric Auto rerun

unit
ABS over >Abs - Decrease Yes
ADC abnormal ADC.E Normal Normal Yes
Calibration result abnormal (Sample flag) Cal.E (Sample flag) Normal Normal No
Calculation not possible Calc.? Normal Normal Yes
Calculated test error ClcT.E No rerun No rerun No
Unable to calculate compensated test CmpT.? Normal Normal Yes
Data error in compensated test CmpT.E Normal Normal Yes
Cell blank abnormal >Cuvet - Normal Yes
Detergent short (carryover evasion) Det.S Normal Normal No
Edited test Edited No rerun No rerun No
Serum index check >Index - No rerun No
ISE voltage level error ISE.E Normal - Yes
ISE noise error ISE.N Normal - Yes
Prozone error 2 / Kinetic unstable >Kin - Decrease Yes
Linearity abnormal >Lin - Normal Yes
Ultrasonic mixing error Mix.E Normal Normal No
Mixing power low level <Mix Normal Normal Yes
Prozone error 1 >Proz - Decrease Yes
Reaction limit over (substrate depletion) >React - Decrease Yes
Reagent expired ReagEx No rerun No rerun No
Reagent short Reag.S Normal Normal No
Repeat limit over (upper / lower) >Rept / <Rept Normal Normal Yes/No due to
setting
ABS maximum over (non-lin curve) Samp.? - Decrease Yes
Sample clot Samp.C Normal Normal No
Sample short Samp.S Normal Normal No
ISE range over >Test Normal - Yes
ISE sample range outside technical limit, >Test For urine: Decrease Yes
photometric unit: Upper/Lower technical Limit Decrease (a)
For others:
Normal
<Test Normal Increase Yes
Table D-4 Rerun list
(a) For Urine Decrease: Can only be requested manually.

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Rerun list

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cobas c 311 analyzer 16 Troubleshooting
Table of contents

Troubleshooting

This chapter provides general information about troubleshooting problems on the

cobas c 311 analyzer.

In this chapter Chapter 16

General troubleshooting .......................................................................................... D-45
Troubleshooting procedures .............................................................................. D-45
Operator's primary responsibility ............................................................... D-45
Calling technical support ................................................................................... D-46
Chemistry problem ...................................................................................... D-46
Instrument problem ..................................................................................... D-46
General instrument troubleshooting ...................................................................... D-47
Troubleshooting at Power Up ............................................................................ D-47
General mechanical problem isolation ............................................................. D-47
Electrical power not available ............................................................................ D-48
Cannot access another software screen ............................................................. D-48
Touchscreen does not come on .......................................................................... D-49
Touchscreen is difficult to see ............................................................................ D-49
Probe does not descend to liquid surface .......................................................... D-49
Bubbles in syringe .............................................................................................. D-50
ISE troubleshooting ................................................................................................. D-51
ISE, all results are erratic, excessive air in sipper syringe ................................. D-51
ISE, results are erratic ......................................................................................... D-51
ISE, high or low internal standard values ......................................................... D-52
ISE, high sodium or low chloride values ........................................................... D-53
Low ISE values .................................................................................................... D-53
Troubleshooting of the photometric unit ............................................................... D-54
High test results .................................................................................................. D-54
Low test results ................................................................................................... D-55
Erratic test results ............................................................................................... D-55
Erratic or biased test results ............................................................................... D-57
Single sample or control .................................................................................... D-57
Single test (1 reagent) ......................................................................................... D-58
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Table of contents

Tests with more than 1 calibration point .......................................................... D-58

Multiple photometric tests (more than 1 reagent) ........................................... D-58
All photometric tests .......................................................................................... D-59
Biased enzyme results ......................................................................................... D-59

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cobas c 311 analyzer 16 Troubleshooting
General troubleshooting

General troubleshooting

This chapter provides general information about troubleshooting problems on the

cobas c 311 analyzer.

Troubleshooting procedures

To identify and isolate problems effectively, you must understand the theory of
operation, operating procedures, emergency procedures and test reaction
descriptions covered in this manual. The following areas are covered:

Application problems o Photometric or ISE

o Reagents
o Samples, controls or calibrators
o Operator error

Instrument problems o Electrical/electronic

o Mechanical
o Operator error

Computer problems o Problems during download procedure, incorrect parameters

o System parameter reading
o Operator error

Facility problems o Heat

o Humidity
o Power supply
o Water supply
o Drain

Operator's primary responsibility

o Reagent, calibrator and control preparation and storage
o Sample preparation
o Computer parameters and general computer input/output operations
o Basic component replacement
o Basic operator technique, including computer operation
o Maintenance

The basic operator is not responsible for troubleshooting electrical problems except as
covered in this part of the Operator’s Manual: Do not attempt removal of printed circuit
boards unless specifically instructed to do so by a Roche representative.

When troubleshooting, observe and record the alarms and isolate the problem to the
area denoted by the alarms. In many cases, you may be able to find the problem,
correct it and then resume processing. The remainder of this chapter provides
instructions and guidelines to aid in isolating problems.

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16 Troubleshooting cobas c 311 analyzer
General troubleshooting

Calling technical support

If it becomes necessary to consult technical support to troubleshoot a test or

instrument problem, be prepared with the following information:
e The items are divided into the following categories:
Chemistry problem on page D-46
Instrument problem on page D-46

Chemistry problem
o account number/customer ID number
o instrument serial number
o analyzer type, serial number, and software version
o test(s) affected and other tests on board
o special wash programming
o description of the problem including relevant alarm(s) and alarm code numbers
o catalog number, lot numbers and expiration dates of reagents
o catalog number, lot numbers and expiration dates of calibrators and controls
o lot number of ISE cartridges
o calibration absorbance values from the last few calibrations performed
o control results from the last few controls performed
o patient results (with correlation results, if relevant)
o Reaction Monitor report for affected test(s).

Instrument problem
o account number/customer ID number
o instrument serial number and software version
o description of the problem including relevant alarm(s) and alarm code numbers
o other instrument or maintenance related information.

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cobas c 311 analyzer 16 Troubleshooting
General instrument troubleshooting

General instrument troubleshooting

This chapter provides information about troubleshooting procedures for the analyzer
as a whole. Procedures for troubleshooting general instrument problems as well as
problems during power up are described.

Troubleshooting at Power Up

Conditions that can affect instrument power up are presented in Table D-5.
To troubleshoot a problem, determine the category below that best describes the
problem, and follow the recommended remedy. If all remedies are unsuccessful, call
technical support.

PROBLEM: The instrument does not power up when the operation power switch (on the right
side of the analyzer unit) is pressed.

NOTICE Damage to the analyzer due to improper power connection

o The analyzer must only be connected to a power supply source with the specified
power supply cable and by trained personnel.
o Always make sure that the power switch is in the off position before plugging in the
analyzer.

Cause or description Remedy

1. Instrument is unplugged. Plug instrument power cord into socket.
2. Main circuit breaker (at the rear of the Switch main circuit breaker to the ON
analytical unit, see Figure A-8 on position.
page A-27) in OFF position.
3. Power switch for the analytical unit is Switch on the power switch of the analytical
switched off. unit.
4. The circuit breaker for the instrument Have your facility electrician check the
power line in your facility is in the OFF appropriate circuit breaker.
position.
5. Control unit workstation power cable is Plug the power cable into the analytical unit.
unplugged at the analytical unit. If the instrument still does not power up, call
technical support.
Table D-5 Troubleshooting at power up

General mechanical problem isolation

The control unit controls and monitors all mechanical functions of the instrument.
When a mechanical problem arises within the instrument, it is immediately
recognized. The alarm indicator on the global Alarm button flashes, alerting you to
the problem. Touch Alarm (global button) to display the Alarm screen with the
specific alarm code, date and time the alarm occurred and a description of the alarm.
Touch a specific alarm to display the alarm details and appropriate remedy.
For certain problems affecting the instrument's performance, the analyzer terminates
the operation mode and enters the sampling stop or stop mode. In the sampling stop
mode, the analyzer allows completion of the samples in process unaffected by the

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General instrument troubleshooting

failure. If the problem affects all samples in process, the computer immediately
terminates the operation mode with a stop or emergency stop.

Incorrect results or damage to the instrument due to unrecognized instrument

problems
CAUTION Certain instrument problems may arise that the analyzer does not monitor. If this is the
case, no alarm will be issued to alert the operator. Such problems may include worn parts,
air leaks in the syringe system, reagent contamination, etc.
When you encounter these types of problems, you must decide whether to continue to
process samples or to terminate the operation, depending on the possibility of causing
damage to the analyzer or reporting erroneous test results.

Electrical power not available

If you have problems powering the analyzer on, follow the steps below:
1 Are the operation ON/OFF switch and circuit breaker switched OFF?
o If yes, then go to step 2.
o If no, then go to step 3.
2 Switch on both power switches.
3 Is the power cable plug disconnected at either the instrument or the outlet?
o If yes, then go to step 4.
o If no, then go to step 5.
4 Firmly connect the power cable.
5 Is the main power outlet working?
o If yes, then go to step 8.
o If no, then go to step 6.
6 Check the circuit breaker in the laboratory distribution box.
7 Ensure line voltage is adequate.
8 If you are still experiencing problems, call technical support.

Cannot access another software screen

If you are unable to access another software screen, follow the steps below:
1 Power OFF the analyzer at the circuit breaker.
2 Check the cabling between the touchscreen and the analyzer.
3 Power ON the analyzer at the circuit breaker. If you are still unable to access
another screen, then call technical support.

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Touchscreen does not come on

If you are having problems with the touchscreen, follow the steps below:
1 Is the operation ON/OFF switch on the front of the touchscreen switched OFF?
o If yes, then go to step 2.
o If no, then go to step 3.
2 Switch the operation switch ON.
3 Is the cable between the touchscreen and the instrument disconnected?
o If yes, then go to step 4.
o If no, then go to step 5.
4 Firmly connect the cable.
5 If you are still experiencing problems, call technical support.

Touchscreen is difficult to see

If the content of the touchscreen is difficult to see, follow the steps below:
1 Is the touchscreen dirty?
o If yes, then go to step 2.
o If no, then go to step 3.
2 Gently wipe the surface with a dry cloth.
3 Is the ambient lighting too bright?
o If yes, then go to step 4.
o If no, then go to step 5.
4 Either reduce the brightness of the ambient lighting or change the direction of the
monitor.
5 If you are still experiencing problems, call technical support.

Probe does not descend to liquid surface

If the reagent and/or sample probe does not descend to the liquid surface, follow the
steps below:
1 Are there bubbles on the liquid surface?
o If yes, then go to step 2.
o If no, then go to step 3.
2 Eliminate the bubbles in the sample container with an applicator stick.
3 Did the probe tip touch something during descent? If yes, remove the obstacle.

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Bubbles in syringe

If you see bubbles in either the reagent and/or sample syringe, follow the steps below:
1 Perform maintenance item (5) Air Purge from Utility > Maintenance. Select
Sample Syringe or Reagent Syringe in the Syringe area.
2 If there are still bubbles in the syringe, repeat this process for the appropriate
syringe.
If bubbles remain in the syringe after the second Air Purge, call technical support.

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cobas c 311 analyzer 16 Troubleshooting
ISE troubleshooting

ISE troubleshooting

This chapter provides information about troubleshooting procedures specific to the

ISE unit.

ISE, all results are erratic, excessive air in sipper syringe

For problems with erratic ISE results and if there is excessive air in the sipper syringe,
follow the steps below:
1 Check reagent volumes in reagent bottles. Are reagent volumes sufficient and is
the ISE Ref. reagent line in the bottle?
If no, replenish reagent. Make sure the ISE Ref. reagent line is at the bottom of the
bottle. Choose Utility > Maintenance and perform (7) Reagent Prime on the ISE
unit (Ref).
2 Is the system leaking?
If yes, check all tubings and connections for leaks. Tighten loose fittings. Check
seals of the ISE sipper syringe.
Choose Utility > Maintenance and perform (7) Reagent Prime on the ISE unit
(Ref).
3 Check position of the measuring cartridges. Are measuring cartridges placed
properly?
If no, place cartridge in correct position. Choose Utility > Maintenance and
perform (7) Reagent Prime on the ISE unit (Ref).
4 Check reference cartridge placement. Is the reference cartridge placed properly?
If no, place cartridge in its proper position. Choose Utility > Maintenance and
perform (7) Reagent Prime on the ISE unit (Ref).
5 If problem recurs, call technical support.

ISE, results are erratic

For problems with erratic ISE results, follow the steps below:
1 Is the ISE Ref. reagent line correctly placed in the bottle?
If no, check line placement, prime reagents and rerun samples.
2 Is there salt buildup on electrodes or the syringe or are there any loose
connections?
If yes, tighten any loose or leaky connections, then clean all salt buildup with wet
gauze and rerun samples.
3 Check sipper line tubing for kinks or occlusions and remove them.
4 Perform maintenance check (2) ISE Check. The Ref. EMF is allowed to be within -
7 mV to +7 mV. The maximum deviation for the entire cycle range should be no
more than ± 2 mV for Ref. EMF. The measurement-to-measurement difference
within the 30 cycle interval should not be larger than 0.2 mV for Na, K, and Cl.

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ISE troubleshooting

If results are not within range, replace ISE reference cartridge. Choose Utility >
Maintenance and perform (7) Reagent Prime on the ISE unit (Ref). Then,
recalibrate and rerun samples.
5 Are there air bubbles in the sipper syringe?
If yes, replace seal in the sipper syringe and prime the ISE IS reagent. Choose
Utility > Maintenance and perform (7) Reagent Prime on the ISE unit (IS).
6 Verify microbial growth is not present in the reagent system. If necessary, clean the
ISE reagent flow path.
e See M1: Washing ISE flow path and sample probe on page C-40.

7 If problem recurs, call technical support.

ISE, high or low internal standard values

For problems with high/low ISE internal standard values, follow the steps below:
1 Is the ISE IS EMF value and the ISE IS concentration value higher than normal?
The Internal Standard EMF deviated ± 2 mV maximum from the mean value
between the Standard Low and Standard High. The concentration of the Internal
Standard ideally lies at:
Na+: 140 mmol/L
K+: 5 mmol/L
Cl–: 100 mmol/L
o If yes, go to step 2.
o If no, go to step 4.
2 Check the ISE IS reagent preparation. Check that the ISE calibrators are correctly
prepared and placed on the analyzer.
Replace reagent or calibrators if required and prime the ISE IS and calibrate.
3 Check the ISE IS syringe assembly. Are there leaks?
If yes, replace the seals and prime the ISE IS.
4 Perform maintenance check (2) ISE Check. The EMF of the reference electrode
must be between -7 mV and +7 mV. The maximum deviation for the entire cycle
range should be no more than ± 2 mV.
o If all values (Na+, K+, and Cl–) are too high or too low, replace the reference
cartridge. An ISE.E data alarm is displayed in the printout adjacent to the
respective EMF if the following limits are exceeded:
Na+: -90 to -10 mV;
K+: -90 to -10 mV
Cl–: 80 to 160 mV
o If only single values (Na, K or Cl) are outside the range, replace the respective
electrode.
5 If problem recurs, call technical support.

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ISE troubleshooting

ISE, high sodium or low chloride values

For problems with high sodium and low chloride values, follow the steps below:
1 Were fresh low and high calibrators used?
If no, recalibrate with fresh calibrators and rerun the samples.
2 Replace ISE IS and ISE Dil. reagents with fresh reagents and perform the following
steps:
o Perform a wash: Choose Utility > Maintenance and perform (10) ISE Wash.
o Prime the fresh reagent: Choose Utility > Maintenance and perform (7)
Reagent Prime on the ISE unit (IS).
o Recalibrate two times with fresh ISE IS.
o Rerun the sample.
3 If problem recurs, call technical support.

Low ISE values

For problems with low ISE values, follow the steps below:
1 Were fresh low and high calibrators used?
If no, recalibrate with fresh calibrators and rerun the samples.
2 Were fresh ISE reagents used?
If no, replace ISE IS and ISE Dil. reagents with fresh reagents and perform the
following steps:
o Perform a wash: Choose Utility > Maintenance and perform (10) ISE Wash.
o Prime the fresh reagent: Choose Utility > Maintenance and perform (7)
Reagent Prime on the ISE unit (IS).
o Recalibrate two times with fresh ISE IS.
o Rerun the sample.
3 Is the correct compensator value (ISE Comp.) entered under Calibration > Install?
For US only, ISE High (compensated) is used instead of ISE Comp.
If no, correct the compensator value.
4 If problem recurs, call technical support.

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Troubleshooting of the photometric unit

Troubleshooting of the photometric unit

This chapter provides information about troubleshooting procedures specific to the

photometric unit.

High test results

For problems with high test results on the photometric unit, troubleshoot according
to the steps below:
1 Incubation bath temperature is incorrect.
o If the bath temperature does not read 37 ± 0.1°C, call technical support.
2 Poor calibration results.
o Check calibrator preparation.
o Check proper calibration programming and calibration results. Repeat
calibration if necessary.
3 Calibrators were not properly prepared.
o Check calibrator preparation and calibration results. Repeat calibration.
4 Evaporation of sample, calibrator or control.
o Repeat analysis with fresh sample, calibrator and/or control.
If calibrators and controls have been loaded on the sample disk for more than
2 hours, evaporation of calibrator may lead to lower results for patient
samples.
5 Reagents were not properly prepared.
o Check reagent preparation and expiration date.
6 Information is not correct Calibration > Install.
o Verify the calibration points on Calibration > Install and compare the
displayed data with the documentation for a specific test.
o Verify the calibration sample volume in the application parameters.
7 Incorrect sampling or dilution of sample.
o Check correct assembly of sample probe and pipetter parts.
o Check all fittings for leaks.
o Replace O-rings and seals.
8 Insufficient reagent volume.
o Check reagent pipetting system for leaks.
o Replace cobas c pack and repeat analysis.
9 Check that the ultrasonic mixer operates properly.
o Perform maintenance check (6) Cuvette Mixing.
e See To check the intensity of the ultrasonic output on page C-81.

10 If you are still experiencing problems, call technical support.

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Troubleshooting of the photometric unit

Low test results

For problems with low test results on the photometric unit, troubleshoot according to
the steps below:
1 Reagents are expired.
o Prepare new reagents (see package insert for stability of the prepared reagent).
2 Reagents were not properly stored.
o Prepare new reagents (see package insert for proper storage).
3 Reagents were not properly prepared.
o Prepare new reagents (see package insert for proper preparation instructions).
4 Incubation bath temperature is incorrect.
o If the bath temperature does not read 37 ± 0.1°C, call technical support.
5 Calibrators were not properly prepared.
o Check calibrator preparation and repeat the calibration with fresh calibrators.
6 Information is not correct on Calibration > Install.
o Check Calibration > Install and compare the displayed data with the
documentation for a specific test.
o Verify the calibration sample volume in the application parameters.
7 Ensure there is sufficient sample in the container. Check instrument specifications
for minimum sample volumes.
8 Check sample for fibrin clotting.
9 Check sample pipetting systems for leaks and air bubbles.
10 Check sample probe for contaminants and obstructions.
11 Repeat analysis with appropriate sample volume.
12 Check sample probe for barbs and proper alignment.
13 Check the cell rinse nozzles are not dripping.
14 Check that the ultrasonic mixer operates properly.
o Perform maintenance check (6) Cuvette Mixing.
e See To check the intensity of the ultrasonic output on page C-81.

15 If you are still experiencing problems, call technical support.

Erratic test results

For problems with erratic test results on the photometric unit, troubleshoot
according to the steps below:
1 Fibrin clot in 1 sample container or in sample probe (if low values printed for
several samples).
o Check sample for fibrin clot; remove fibrin and repeat analysis.
o Check sample probe for fibrin clot; clean probe (perform maintenance item
(11) Sample Probe Wash) and perform an air purge.
e See also M2: Cleaning pipetter probes and ISE sipper on page C-44.

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Troubleshooting of the photometric unit

o Replace sample probe and sample probe seal.

2 Sample probe does not reach the bottom of the reaction cell when dispensing
sample.
o Perform mechanisms check and verify that the probe reaches the bottom of
the cell.
o Check the spring mechanism to make sure the probe moves up and down
freely.
o The sample probe tip may be damaged. Replace the sample probe.
3 Maintenance was not performed properly or at the recommended frequency on
sample or reagent pipetter or probe.
o Check the Maintenance screen and perform any overdue maintenance
functions.
o If maintenance was recently performed on the sample probe, reagent probe,
rinse nozzles, or any pipetters:
O Was an air purge performed after maintenance?
O Were all parts correctly assembled?
O Have all tubings and seals been checked for air leaks?
O Were sample and reagent probe seals replaced?
4 Insufficient sample volume.
o Repeat analysis with sufficient sample.
5 Contaminated incubation bath.
o Check for particles in the incubation bath. If particles exist, perform the
incubation cleaning procedure
e See: M9: Replacing reaction cells and cleaning incubator bath on page C-62
o Check for foaming, perform incubation bath exchange.
o Check for sufficient Hitergent on the analyzer. Perform incubation water
exchange.
6 Check for sufficient volumes of cell cleaning detergents.
7 Observe cell wash for proper operation:
o Are wash/rinse solutions being properly added and aspirated?
o Are cells being dried?
8 Check proper probe wash and cell wash programs are in place.
9 Check that the ultrasonic mixer operates properly.
o Perform maintenance check (6) Cuvette Mixing.
e See To check the intensity of the ultrasonic output on page C-81.

10 If you are still experiencing problems, call technical support.

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Troubleshooting of the photometric unit

Erratic or biased test results

For problems with erratic or biased test results on the photometric unit, troubleshoot
according to the steps below:
1 Verify that the deionized water supply is free from contamination.
2 Check calibrators used on all units.
o Calibrators were not properly prepared. Repeat calibration with fresh
calibrator.
o Check calibrator preparation.
3 Information is not correct on Calibration > Install.
o Verify the calibration points on Calibration > Install and compare the
displayed data with the documentation for a specific test.
o Check that the calibration sample volume in the application parameters is
correct.
4 Check sample for fibrin clotting.
5 Ensure there is sufficient sample in the container. Check instrument specifications
for minimum sample volumes.
o Repeat analysis with appropriate sample volume.
6 If you are still experiencing problems, call technical support.

Single sample or control

For problems with a single sample or control on the photometric unit, troubleshoot
according to the steps below:
1 Verify samples and controls are placed in the proper positions. If necessary,
correct the sample or control placement and rerun the sample.
2 Verify the control value ranges and lot numbers entered on QC > Install are
correct. If necessary, correct the control value range or lot number on QC >
Install.
3 Verify the sample and/or control volume is sufficient. Verify the selected sample
cup on Workplace > Test Selection.
4 Verify the sample integrity is acceptable (fibrin, lipemia, hemolysis, icterus). If
necessary, collect fresh sample and rerun.
5 Verify the appropriate sample type is selected (serum/plasma, CSF, urine,
supernatant, other) and the specimen was collected appropriately. If necessary,
correct the sample type; check the package insert for acceptable specimen types.
Check the specimen collection; check the package insert for acceptable specimen
collection methods.
6 Verify the collection time and date of the sample are correct. If necessary, collect
fresh sample.
7 Verify correct test selections were made on Workplace > Test Selection. If
necessary, correct any selections and rerun the sample.
8 If you are still experiencing problems, call technical support.

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Troubleshooting of the photometric unit

Single test (1 reagent)

For repeated or consistent problems with a single test on the photometric unit,
troubleshoot according to the steps below:
1 Verify that reagents have not expired, or are not contaminated or discolored. If
necessary, insert a new cobas c pack.
2 Verify the correct calibrator code and setpoints are used. If necessary, correct the
calibrator code and setpoints and repeat the calibration.
3 Verify the special wash programming, if applicable.
4 If you are still experiencing problems, call technical support.

Tests with more than 1 calibration point

For problems with tests with more than 1 calibration point on the photometric unit,
troubleshoot according to the steps below:
1 Verify calibrators were properly prepared and stored. If necessary, prepare new
calibrators and recalibrate.
2 Verify the assigned calibrators are in the correct positions. If necessary, place
calibrator(s) in correct position(s), recalibrate and rerun samples. Verify that
required diluents are on board.
3 If you are still experiencing problems, call technical support.

Multiple photometric tests (more than 1 reagent)

For problems with multiple tests on the photometric unit, follow the steps below:
1 Verify there are sufficient volumes of special wash solutions and detergents. If
necessary, replace needed special wash solutions, detergent and rerun samples.
2 Check the reagent probe for barbs, obstructions or leaks.
3 Verify the reagent system is not leaking. Perform an air purge. If the system is
leaking, check connections in the reagent pipetter and check connections in the
reagent syringe.
4 Verify the incubation bath is free of debris and foam. If necessary, perform
incubation bath maintenance.
5 Perform a photometer check. Verify the Photometer Check report is within
acceptable limits (< 14000). If it is not, replace the photometer lamp. Perform a
cell blank. Calibrate all photometric tests.
6 If you are still experiencing problems, call technical support.

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All photometric tests

For problems with all photometric tests on the photometric unit, troubleshoot
according to the steps below:
1 Verify the sample probe is not blocked or does not have barbs at the tip. If
necessary, clean/replace the probe. Perform an air purge. Check proper dispense.
2 Verify the sample system is not leaking. If necessary, check tubings and
connections. Perform an air purge and check if there are air bubbles in the syringe.
3 Verify controls/calibrators were properly prepared and stored. If necessary,
prepare new controls/calibrators.
4 Check that the ultrasonic mixer operates properly.
5 Check photometer lamp.
6 If you are still experiencing problems, call technical support.

Biased enzyme results

For problems with biased enzymes on the photometric unit, troubleshoot according
to the steps below:
1 Verify the incubation bath level is above the photometer lens.
2 Verify the incubation bath temperature displayed on the System Overview screen
is 37 ± 0.1°C. Verify there is no Incubation Bath Temperature alarm present.
If the temperature is out of range, perform an incubation water exchange, allow
the temperature to stabilize and recheck the bath temperature. If the temperature
is still unacceptable, call technical support.
3 Verify the sample and reagent syringe seals are in good condition. If necessary,
change the syringe seals.
4 Verify the syringe fittings are not loose. If necessary, correct any loose fittings.
5 Verify controls were prepared using volumetric pipettes. If not, prepare new
controls using a volumetric pipette.
6 Perform a full calibration or blank update.
7 Perform a Photometer Check. Verify the Photometer Check report is within
acceptable limit (< 14000). If not, replace the photometer lamp. Perform a cell
blank. Calibrate all photometric tests.
8 If you are still experiencing problems, call technical support.

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17 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
cobas c 311 analyzer Glossary
absorbance (Abs) - calibration monitor

Glossary

This glossary is a compendium in which to look up the barcode type Typical sample barcode types used in the
meaning of technical terms used in conjunction with the IVD industry are Code39, NW7 (Codabar), ITF, and
cobas c 311 analyzer. Code 128.

bichromatic measurement Photometric technique

A measuring absorbance values at two different
wavelengths (primary and secondary wavelength).
absorbance (Abs) The instrument displays an
absorbance by ten-thousandfold value.
C
assay 1. A specific test.
2. A procedure where the concentration of an analyte in a calculated result See calculated test.
sample is determined.
calculated test A test result calculated from different
assigned value (Roche-defined) Roche-defined individual tests with a given formula such as ratio A/B.
concentration for calibrator material that is encoded on
the calibrator barcode card or transfer sheet. calibration The process that establishes the relation
between measured signals (e.g. from a photometer,
Automated Download (ADL) A service that provides photomultiplier, or ion-selective electrodes) and
information necessary for analysis (such as analytical corresponding concentration values of a calibrator.
parameters) from the data center. ADL is a cobas
TeleService application. See also cobas TeleService. calibration curve A plot of measured signal values
(determined during calibration) versus known
automatic calibration 1. Automatic timeout concentration values of calibrators.
calibration. A calibration of a parameter performed if a
specified time interval expires. The calibration can be calibration factor The reciprocal value of the slope (K)
defined for each method separately. of a calibration curve (only applicable to linear
2. Automatic calibration after a cassette or a cassette of a calibrations). One of the factors used to create a
new lot is registered. The calibration can be defined for calibration curve (S1Abs, K, A, B, C).
each method separately.
3. Automatic calibration on QC failure. A calibration calibration frequency A specified interval at which an
request is generated by the system if a QC value is outside assay should be calibrated. Also referred to as calibration
a predefined range. stability. It is implemented in the application parameters
which are downloaded via cobas link.
automatic QC A quality-control function that
automatically samples QC material, test-specifically calibration function The type of calibration (for
according to defined time intervals. example, Rodbard function, linear function, or cutoff
function). A mathematical model that describes the
automatic rerun The repetition, without operator relationship between a signal and a concentration in the
intervention, of tests that have results with data alarms. calibration curve. See calibration curve.

auxiliary reagent A non-test-specific reagent that is calibration masking A function that masks a reagent
needed to wash and rinse reaction cells, sample probes when no valid calibration is available.
and reagent probes.
calibration monitor A function that prints the
B measured absorbance of the standard solution and the
calibration factors, at the time of calibration, for every
barcode mode The operational mode when a system is measurement item.
configured to operate using barcoded samples.

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Glossary cobas c 311 analyzer
calibration NOW - Code39

calibration NOW A system-generated cell blank measurement, reaction cells can be screened
recommendation to carry out calibration within a for contamination or damage.
forthcoming defined time interval (Remaining time on
Calibration > Status screen). cell rinse unit A device for cleaning the reaction cells
with detergent and water and for dispensing and
calibration quality criteria Calibration checks aspirating cell blank water.
applied to the auto-validation of every calibration on the
analyzer. check digit A verification number used in barcodes
and software.
calibration trace A graph used to review the
measurements of the 50 most recent calibrations for a check sum The result of a mathematical procedure to
specific test. validate the integrity of a set of data.

calibration type 1. One of the following: Linear, RCM, circuit breaker See main circuit breaker.
RCM2T1, RCM2T2, Spline, Line Graph. Each calibration
type corresponds to one specific type of mathematical clot detection 1. A device built into the pipetting
function. See calibration function. system to detect clots and to avoid false pipetting.
2. Lot calibration or cassette calibration. 2. The procedure of detecting a clot.

calibration validation Analysis, performed by cobas® The "umbrella brand name" for a broad range
software, to check a calibration data set against specific of products and services for use in professional IVD
criteria. Calibration validation results are: successful or laboratories and physician's office settings.
failed.
cobas c pack The name of the reagent cassette used on
calibrator A material of known composition and cobas c systems and COBAS INTEGRA® systems.
properties that can be presented to the analytical COBAS INTEGRA cassettes can also be used on the
instrument for calibration purposes. cobas c 311 analyzer.

calibrator code The identification number of the cobas c pack MULTI The name given to an empty,
standard solution in calibration measurement. but assembled and barcoded kit cassette that can be used
for Roche or non-Roche reagents. The word MULTI in
capacitance An electrical property that provides the this name stands for multi-purpose. The cobas c pack
basis for liquid level detection in sample probes. The MULTI has to be assigned to a development channel
probes carry a high-frequency, low-voltage electrical application before loading it onto the analyzer.
charge. Frequency and electrical charge characteristics
are altered and sensed when the probe touches liquid. cobas link The infrastructure of network connections
that enables cobas TeleService to exchange information
carryover Contamination of a reaction mixture of one between the Roche service network and a customer's
assay by reagent(s) or sample material of another laboratory.
(previous) assay.
cobas link data station A dedicated desktop
cassette The integrated reagent carrier consisting of computer, located in the laboratory, that has been
one or more reagent bottles and barcoded labels. The configured to act as a gateway between Roche systems
term cassette, on cobas systems, is used generically to and the Internet. As well as providing a communication
refer to cobas c packs, cobas c pack MULTI, or COBAS link, the data station also stores data and documentation
INTEGRA cassettes. for assay processing and can provide a data archive.

cassette calibration Calibration data are specific to a cobas TeleService The set of software applications
single cobas c pack. Most of the photometric tests need to that use cobas link to exchange service information
be calibrated only if the reagent lot is changed (lot between Roche service network and a customer's
calibration). See lot calibration. laboratory. cobas TeleService provides remote
monitoring and diagnosis, hotline support, and software
cell blank The process of measuring the absorbance of and documentation updates.
all reaction cells, filled with water, at all wavelengths. The
cell blank values are stored on the hard disk. By periodic Code39 A barcode type for sample tubes that can be
read by the barcode reader.

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E-4 Operator’s Manual · Version 1.0
cobas c 311 analyzer Glossary
coefficient of variation - dynamic range

coefficient of variation A statistical measure used to D

describe imprecision. Often abbreviated to CV.
data alarm Printed or displayed notification that
compensated test A test that has the result modified occurs if a result (including calibration or QC results) is
by a formula that takes account of known or defined unexpected or abnormal; an indication of unusual
interference factors. reaction or instrument conditions, for example,
insufficient sample or reagent.
Complete A system status found on several screens
indicating that all requested determinations have been data flag See data alarm.
completed.
dead volume See minimum sample volume.
conditioning The process of letting serum-type liquid
flow through the flow path before electrolyte default profile A predefined set of tests that the
measurement. analyzer automatically applies to a sample unless the
operator specifies a different set of tests.
control ID The abbreviated name for a control
material, for example PNU and PPU. Control IDs are demographics Patient-related data such as name, date
used on software screens and windows where limited of birth, and gender.
space prevents the use of longer names.
development channel An open application where all
control material A material of known composition parameters must be set manually. Any non-standard
used to assess the performance of an analytical procedure reagents can be used but must be filled into the
or part of an analytical procedure. Also called the control cobas c pack MULTI. A development channel application
sample. has to be downloaded and installed via cobas link.

control name The name of a control material, for deviation of duplicate measurements See duplicate
example Precinorm Universal. limit.

control SD value The acceptable variation SD value of dilute waste solution A waste solution resulting after
a quality control sample. rinsing with water.

control unit A computer by which an analytical system dilution factor A software preset or manually assigned
is controlled. The control unit also serves as the user dilution ratio that is used by the analyzer to perform a
interface. requested dilution.

correction item A function that corrects the disk position A dedicated position on the reagent or
measurement result of one item by using figures or the sample disk.
measurement result of other tests.
down time The period of non-operation between an
cumulative QC The accumulated data and associated instrument failure and the resumption of operation.
statistics of individual QC data.
dual value method A mode of expression of the
cup-on-tube The placement of a smaller secondary control chart in real-time quality control. For X-axis and
sample container (for example a Hitachi Cup) on top of a Y-axis, measure simultaneously the average and the
primary sample tube. standard deviation of control of a low value and a high
value, and display them by X and Y coordinates,
cycle The instrument time interval during which respectively.
pipetting or measurement can be carried out.
duplicate limit A calibration quality criterion. For a
cyclic QC Controls run at fixed intervals. successful calibration, duplicate measurements must be
within a specified limit.

dynamic range The reportable range of an assay. This

range extends from the lower detection limit to the limit
of linearity.

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Operator’s Manual · Version 1.0 E-5
Glossary cobas c 311 analyzer
electromotive force (EMF) - internal standard solution (ISE IS)

E H
electromotive force (EMF) The physical principle Hitergent 1. A detergent, with antibacterial properties,
that provides the basis for electrolyte measurement. The that can be added to the reaction bath where it acts as a
EMF is measured in millivolts surfactant, reducing the formation of foam.
2. A surfactant diluted for use in some cleaning
emergency stop An instrument alarm level that procedures.
immediately stops all instrument functions. See also E-
stopped. homogeneous immunoassay (HIA) An analytical
technique employing antigens and antibodies. An HIA
endpoint assay An analytical technique taking uses assay protocols similar to clinical chemistry without
measurements after a reaction is completed or has been a bound-free separation (for example, latex assays).
halted. See also rate assay.
Host communication Data exchange with a clinical
error handling A process during which the analyzer laboratory information system (LIS).
attempts to recover from an error condition. If the
analyzer cannot successfully recover from error, an alarm Host computer 1. A computer used for overall
is issued and the instrument is halted. management and control of the computer network.
2. A clinical laboratory computer that stores and
E-stopped A status indicating that the system has processes patient requests and results. A Host is able to
performed an emergency stop (E. Stop). This could be communicate with analytical instruments.
due to hardware failure or because any of the safety
devices have requested an emergency stop. The system Host interface protocol A technical description that
requires either complete power off, or at least defines data transfer between a Host computer and an
initialization, to resume normal operation. analytical system.

expected range The predefined range of test result

values expected for a defined group of healthy patients or I
materials. Also known as "normal" range or "reference"
range. ID reader Typically an optical device that reads the
identification code of a patient sample and transfers it to
expected value A value for a test result that can be the instrument database.
considered as a "normal" result.
increased volume rerun A rerun performed after
expiration date Also called the expiry date. The end of increasing the amount of sample used for the
a period until which Roche guarantees product claims for determination.
its reagents, calibrators, and controls.
incubation bath See reaction bath.
extended dynamic range The measuring range for
an assay at its highest dilution. Initialization The operational mode of an analyzer that
occurs immediately after power on and during which the
instrument prepares itself for operation.
F
instrument alarm A displayed alarm that indicates an
first registration The date and time when a reagent or unusual instrument condition such as an abnormal
sample was successfully recognized by the barcode reader reaction bath temperature or a mechanical malfunction.
for the very first time.
Instrument Manager Typically, PC-based software
functional sensitivity The concentration of an analyte that controls or supervises one or more analytical
at which a predefined level of imprecision is obtained. instruments.

internal standard solution (ISE IS) An internal

G reference solution, assayed between every ISE sample,
that compensates for electronic drift.
global button A button that allows access to the global
software screens and that can be used at any time.

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cobas c 311 analyzer Glossary
ISE check - on board

ISE check A maintenance function for checking manual dilution An off-system, preanalytical step
whether electrolyte analysis can be performed correctly. performed by laboratory staff to reduce the analyte
concentration in a sample.
ISE drain port Port that discharges reaction waste from
the ISE unit and collects it in a container. manual rerun A retest function. Although a list of
samples required for a rerun is created by following data
ISE Ref. See reference solution (ISE Ref.). alarms, rerun is not carried out automatically. After
organizing the rerun sample list, the operator directs the
rerun.
K
masking A function that temporarily suspends the
K factor A factor used in conversion of absorbance measurement or calibration of a specific test, depending
values to concentration values or activities. on the condition of the instrument or reagent.

Material Safety Data Sheets (MSDS) Documents

L that list components of chemical solutions and
precautions for the handling and disposal of the
liquid level detection (LLD) The ability of an solutions.
analytical instrument to sense liquid by using the sample
or reagent probes. measure point Time at which absorbance reading is
taken and used to calculate results.
liquid waste container A reservoir for liquid waste
generated by an analyzer; its size and location vary measuring range See reportable range.
between instruments.
Microcup A secondary sample cup made by Hitachi
log file A set of data, typically stored in the control unit, with a small dead (residual) volume.
that traces instrument-related or operator-related
activities such as maintenance. minimum sample volume The sample volume that
must be present in a container to ensure faultless sample
lot calibration A mandatory calibration when a new aspiration. Otherwise, a Sample Short alarm will occur.
lot of reagents is introduced to an analytical instrument. The minimum sample volume depends on the size and
shape of the sample container. Also called dead volume.

M Multiclean 1 N NaOH solution for cleaning the sample

probe.
main circuit breaker Main power switch at the rear of
the instrument. It controls the power supply of the entire
analyzer including the cooling unit (usually not switched N
off).
non-barcode mode A mode of instrument operation
maintenance item A maintenance procedure in which the instrument identifies samples by sequence
performed by the system or the operator. numbers corresponding to their positions on the sample
disk.
maintenance key A button for position movement,
used for a probe position check. normal range See expected value.

maintenance pipe A combination of sequential

maintenance items programmed into a fully automated O
procedure, which can be performed by the analyzer
without operator intervention. on board 1. A technical device or function that is part
of the analytical instrument and can be used by the
maintenance procedure A procedure that must be instrument at any time.
performed on a regular basis (for example daily, weekly, 2. The availability of reagents and consumables on an
monthly, or every three months) to secure reliable analytical instrument for use at any time.
operation of the analyzer.

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Glossary cobas c 311 analyzer
one-way serial processing - protocol

one-way serial processing Sample flow and pipe See maintenance pipe.
processing along a single, serial process lane that allows
no bypass function and no rerun. pipetter A device used for pipetting (aspirating and
dispensing) a fixed amount of sample or reagent from a
Online Help On-screen documentation that a user can sample or reagent container to reaction vessel.
request in a context-sensitive manner and search for any
given term. plunger A rod that connects with the drive arm and
moves up or down, depending on the pipetting amount.
online support A service that supports the preparation
for analysis and maintenance management by post-analytical The sample management process,
exchanging information over networks. See also cobas typically storage and archiving, after results have been
TeleService. reported.

open request An ordered test that has not yet been potentiometric assay An assay in which analytes (for
performed or completed. Results for a sample may be example Na, K, or Cl) are measured in millivolts by ion-
partially available while some tests are not yet completed. selective electrodes.

Operate The operational mode during which the Power Up The system status while it is loading
instrument processes samples. programs, performing self-checks, and so on.

operator ID An alphanumeric ID that a system uses to pre-analytical The sample management process before
identify a particular operator. There are several levels the analytical phase. Preanalytical processing typically
including operator, supervisor, and administrator. involves actions such as sorting and aliquoting.

order Also called a request. A test selected for a specific precision The closeness of agreement between
sample or control. independent test results obtained under prescribed
conditions.
order date/time A field used to maintain the arrival
date and time of an order in the laboratory. The date/ pre-dilution A dilution step performed before samples
time data may be entered manually or transmitted by LIS are analytically processed on the analyzer.
protocols.
preventive action A series of actions, suggested by the
order ID The sample order identification refers to a system, that the operator should perform before daily
number of sample tubes (one or more specimen types) of operation to ensure sufficient inventory during the day
a given patient collected for a panel of different tests. (for example, the replenishment of reagents and
Typically, the sample order identification is printed on consumables).
order sheets.
primary tube The original tube containing the sample
that has been drawn from the patient.
P
profile A user-defined set of test requests.
patient ID A set of alphanumeric data that
unmistakably identifies a particular patient. For example, protocol 1. A convention or standard that controls or
a social security number and a sample number. enables the connection, communication, and data
transfer between two computing end points. Protocols
photometric assay An assay in which analytes are can be implemented by hardware, software, or a
measured by a photometer. combination of the two.
2. A set of rules that guides how an activity must be
photometric window A window that enables light to performed.
pass from the light source lamp and into the reaction
bath.

piercer A device that pierces the caps of a cobas c pack.

pinch valve A valve that pinches the suction tube and

switches the flow path.

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cobas c 311 analyzer Glossary
prozone - rerun

prozone The antigen/antibody complex formation is reaction disk A rotatable disk that holds the reusable
predictable as long as an excess of reagent (antibody) reaction cells used for photometric measurement.
exists. However, in patient samples with very high levels
of antigen, the reaction may begin to reverse reagent compartment A temperature-controlled
(deagglutination) because of the effect of the excess section on an analyzer that holds reagents and diluents.
antigen. This is called a prozone effect, and without
checking for this phenomenon, abnormally high samples reagent disk The device in the reagent compartment
may give incorrect or even false normal results. There are into which cobas c packs are placed.
two prozone check methods available: Antigen readdition
method and reaction rate method. reagent mask A function that automatically stops
analysis of the current test when a required reagent is
empty or not present on the system. A red bar appears on
Q the test key in the test selection screen.

QC error An alarm generated in realtime QC when reagent prime A procedure that fills the ISE reagent
either a low value or a high value exceeds the limit of lines and syringe with reagent.
3 SD (QC error 1) or 2.5 SD (QC error 2).
reagent probe Probe used to transfer reagents from
qualitative assay An assay that does not allow the the reagent bottles to the reaction cells.
determination of the concentration of an analyte, but
yields a classification of the sample, such as reactive/ reagent probe rinse station An area located between
nonreactive or positive/negative, with regard to a certain the reagent disks and reaction disk where reagent probes
analyte. are rinsed both internally and externally with water.

quantitative assay An assay that allows the realtime QC Real-time quality control. A method in
determination of the quantity (concentration or activity) which two quality control samples of low and high values
of an analyte. are measured, the quantitative values are judged in real
time, and an alarm is generated if necessary.
query download A communication process between
instrument PC and LIS by which a predefined data set is recalibration The repetition of a calibration.
transmitted upon request of the analytical instrument.
reference electrode Electrode through which the
reference solution flows to provide a reference potential
R for ISE measurements (also called reference cartridge).

random access The ability of an analytical instrument reference solution (ISE Ref.) A KCl solution
to process requests from a patient sample in any order. aspirated through the ISE reference cartridge. Also
known as ISE Ref. or reference electrode solution. See
rate assay A determination in which measurements reference electrode.
are taken as the reaction proceeds. The rate of the
reaction is proportional to the sample component being reflex testing A request for additional testing based on
analyzed. Also known as a kinetic assay. customer-defined algorithms or rules and previous test
results.
raw data The unprocessed values obtained during the
analytical process on an instrument (for example mVolt repeat limit A user-definable limit at which a test is run
or absorbance). again under unchanged conditions.

reaction bath A bath for keeping reaction cells at a reportable range The range of results that can be
defined temperature (37°C). Also called incubation bath reported for the assay. It stretches from the lower
or incubator bath. detection limit to the high end of the calibration curve.

reaction cell A plastic cuvette into which sample and request See order.
reagents are pipetted for the chemical or immunological
reactions. rerun The performance of the same test on a sample
again under changed conditions.

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Glossary cobas c 311 analyzer
rerun – concentrated - standby reagent QC

rerun – concentrated The performance of the same sample probe Pipetter probe used to transfer sample
test with a less diluted sample, either by decreasing the material from sample containers to reaction cells.
diluent or by increasing the sample volume.
sample tube A glass or plastic container for liquid
Reset Operational mode during which the analyzer sets samples to be used with the system. It may or may not
and aligns all mechanical parts to their home positions. have a barcode label, which may be used for positive
sample identification. A sample tube contains sample of
Result Date/Time The instrument fills the result date one specific specimen (sample) type.
and time after the result calculation is finished. It may be
maintained by work area management systems for sample type One of four types of sample that can be
information purpose. analyzed: serum/plasma, urine, cerebrospinal fluid
(CSF), and supernatant. The sample volume and normal
rinse bath See rinse station. value are settable for each type.

rinse nozzle A nozzle that supplies or drains detergent sampling stop An instrument alarm level that
or water used for rinsing reaction cells. indicates a problem with the sampling system. See also
S.Stop.
rinse station A technical device that cleans probes or
disposable tips with deionized water or cleaning secondary tube A sample container of variable size
solutions to avoid contamination and carryover. into which aliquots are transferred

Rodbard function A mathematical function used to sequence number When operating in non-barcode
convert measured signals into concentrations. It uses mode, samples are identified by a sequence number and
four parameters to define the shape and position of their position in the sample disk. This assignment has to
calibration curves. be done on the Workplace > Test Selection screen.

serum index A function by which the absorbance

S characteristics of the samples are described to assess the
presence of lipemia, hemolysis, and icterus.
S.Stop Abbreviation for sampling stop. A system
operating mode in which no new samples are pipetted, sipper A device to aspirate liquid from a vessel into a
but samples already pipetted will be completed without flow path, for example, ISE measuring flow path.
interruption or loss.
Sleep mode Also called sleeping. A mechanical and
S1Abs The absorbance of standard solution 1. The electrical status of an analytical instrument during which
displayed value is 10000 times greater than the actual no immediate processing can be initiated by the operator.
measured absorbance.
SMS Selective Mode Solution, 0.2N HCl in a
sample blank The absorbance of the sample plus cobas c pack for cleaning the reagent probe and in a
reagent 1 of a photometric test. The sample blank is 70 mL bottle for cleaning the sample probe.
subtracted from the actual absorbance reading to obtain
the absorbance value relevant for the result calculation. Stand By An operational mode of the analyzer during
which power is on but no sample analysis or maintenance
sample cleaner SMS and Multiclean. See Multiclean procedures are being performed.
and SMS.
standard Traceable reference material used to create a
sample cup A small container that is used for samples (master) calibration curve. Also referred to as calibrator.
and also for calibrator and control material. Sample cups
can be inserted into 16-millimeter sample tubes (cup on standard deviation A statistic used as a measure of the
tube) or can be used without tubes. Compared to a dispersion or variation in a distribution of data.
sample tube, a sample cup allows the use of smaller liquid
volumes and so reduces the dead volume. standby reagent QC The measurement of a quality
control sample from a reagent that is on board the
sample ID A set of alphanumeric data that analyzer but not presently in use for routine testing.
unmistakably identifies a particular sample. See also
patient ID.

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cobas c 311 analyzer Glossary
Start up - water supply tube

Start up An operational mode of an analyzer, following timeout QC A function that measures the quality
power-on, during which the instrument prepares itself control sample for the specified item at certain time
for operation. intervals.

STAT application A special test application (for turn-around-time 1. The time between the decision to
example, reduced incubation time) for STAT or perform a test and the time when the doctor receives the
emergency samples to achieve faster result reporting. result and can act on it.
2. Inside the laboratory (Lab-TAT): Time between
STAT sample Emergency sample. Results will be receiving a sample and sending out the validated result.
available within shortest possible time.

STAT sample position Reserved positions in the U

sample disk for STAT samples, which will be processed
with priority. ultrasonic mixer A mechanical unit, in a waterproof
pack, that generates ultrasound used to stir samples.
SysClean An auxiliary reagent used for the periodic
cleaning of the ISE unit.
V
system error 1. A calibration quality criterion that
originates from a hardware failure while a calibration validation The process of checking results or data
measurement is performed. against defined rules or ranges in clinical laboratories.
2. The generic term for a case of instrument-related Validation can be against technical or clinical criteria.
problems.

system reagent See auxiliary reagent. W

systematic error An error that is generated by a cause water supply tank A tank used to store deionized
giving deviation to measured values. An alarm generated water.
when control of a low value or a high value is changed in
the same direction in realtime quality control. water supply tube A tube for connecting a water
supply tank and an analyzer.

T
target range The allowed range of recovery for an
analyte in a control material.

target value The mean of all participant responses

after removal of outlying values.

technical limit The dynamic range of an assay.

test code The abbreviated name for a test. This code is

displayed on test buttons shown on software screens or
windows.

test principle A technique that serves as the basis for

designing an assay to detect or quantify analytes.

test protocol The sequence of test steps used to

perform an assay (for example, volumes and timings).

timeout calibration An instrument mode that

automatically generates a calibration request after a
predefined interval.

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Operator’s Manual · Version 1.0 E-11
Glossary cobas c 311 analyzer
water supply tube - water supply tube

Roche Diagnostics
E-12 Operator’s Manual · Version 1.0
Index F
cobas c 311 analyzer Index

Index

Symbols Application auto masking, B-183

Application data, A-33
<Mix (data alarm), ISE unit, D-14 Application parameters
<Mix (data alarm), photometric unit, D-22 – description, B-180
>Abs (data alarm), photometric unit, D-17 – installation process, A-33
>Cuvet (data alarm), photometric unit, D-19 Application report name, B-187
>Index (data alarm), photometric unit, D-11, D-20 Application settings
>Kin (data alarm), photometric unit, D-21 – autmatic rerun, B-187
>Lin (data alarm), photometric unit, D-21 – auto masking, B-183
>Proz (data alarm), photometric unit, D-22 – calibration timeouts, B-184
>React (data alarm), photometric unit, D-23 – expected values, B-190
>Rept / <Rept (data alarm) – qualitative fields, B-189
– ISE unit, D-15 – repeat limit, B-188
– photometric unit, D-23 – report name, B-187
>Test (data alarm), ISE unit, D-16 – technical limit, B-187
>Test / <Test (data alarm) Approvals, 3
– ISE unit, D-16 Approved parts, A-7
– photometric unit, D-24 Archive
– saving patient data, B-89
Numerics – saving system parameters, B-217
Areas of the analyzer, overview, A-24
3rd Results Acceptance, B-195 Assigning
– barcoded samples to calibrator positions, B-98
A – calibrator positions, B-138
– STAT positions, B-194
Abbreviations, 9 – tests to units, B-203
Abnormal conditions, during operation, B-30 Assignment
Absorbance, reaction course, A-57 – calibration curve, B-136
Access – Key setting window, B-199
– cannot access another software screen, D-48 – mandatory tests, B-42
– no access due to operator level, B-9 – non-barcode mode, A-42
– random access, E-9 – Test Assignment window, B-203
Access lamp for sample disk, A-36–A-37 AU, abbreviation, 9
Accessory Auto masking, Utility > Application screen, B-183
– cobas c pack MULTI, B-101 Automatic Printout, B-52, B-69
– printer, A-30 Auxiliary reagents
Accuracy/precision of measured results, A-6 – for ISE applications, B-97
Activate – for photometric applications, B-100
– control, B-169 – ISE applications, B-97
– test, B-169 – overview, A-64
ADC.E (data alarm) – sample probe, A-36
– ISE unit, D-9
– photometric unit, D-18 B
Alarm
– check for, B-35 Backup
Alarm indication, D-7 – overview, B-68
Alarm levels, D-7 – patient data, B-89
Alarm screen, reviewing, B-35 – system parameters, B-217
Analytical unit (analyzer), location, A-23 – test results, B-68
Application Backup function, A-32, A-34
– loading new application parameters, B-174 Barcode
– troubleshooting, D-45 – read error, B-86

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Index cobas c 311 analyzer

– scan range on sample containers, A-77 Calibration timeouts, B-184

– specification of barcode types, A-76 Calibrator
– specification of labels, A-77 – assign position, B-138
Barcode reader – for ISE applications, B-98
– for cobas c packs, A-46, A-47 – load calibrator, B-51
– for samples, A-37 – measuring, B-52
Biased results Calibrator data, A-33
– enzyme results, D-59 – loading, B-131
– troubleshooting, D-57 Calling technical support, D-46
Biohazardous materials, A-8 Carryover
Bubbles, in syringes, D-50 – auxiliary reagents, B-100
Buttons – evasion, B-209
– global buttons, B-10 – rinse station, A-39, A-45
– software basics, B-18 Cartridge
– standard buttons, B-19 – ISE measurement, A-60
– with black triangles and gray buttons, B-19 – reference, A-60
Caution, safety classification, A-5
C Cell blank, abnormal (data alarm), D-19
Cell cleaners
Cal.E (Calib flag), ISE unit, D-25 – See cell wash.
Cal.E (Sample flag) Cell detergents
– photometric unit, D-18 – See cell wash.
Cal.E (Sample flag), ISE unit, D-10 Cell rinse unit, A-52
Calc.? (data alarm) Cell wash
– ISE unit, D-9 – clean aspiration filter, C-69
– photometric unit, D-18 – overview of solutions, B-100
Calculated test – programming special washes, B-211
– program, B-204 – replacement, B-109
– programming, B-204 Changeover calibration, B-118
Calculated test formula Characteristics, of the system, A-26
– deleting, B-206 Check boxes, B-21
– entering, editing, B-204 Checking
Calculation – abnormal sound, B-30
– not possible (ISE unit), D-9 – alarms, B-35
Calibration – calibration and QC results, B-53
– Calibration > Calibrator screen, B-137 – water leakages, B-30
– Calibration > Install screen, B-131 Chloride
– ISE unit, B-123 – ion-selective electrode, A-60
– load calibrator, B-139 – low values, D-53
– request, B-49 Circuit breakers and fuses, A-12
– review data, B-125 ClcT.E (data alarm)
– reviewing measurements, B-126 – ISE unit, D-10
– start-up calibration, B-124 – photometric unit, D-18
– validating, B-53 Cleaning
Calibration > Calibrator screen, B-137 – cell rinse nozzles, C-47
Calibration > Install screen, B-131 – detergent aspiration filters, C-68
Calibration and QC Load List – inlet water filter, C-93
– load calibrators and controls, B-51 – ISE drain port, C-49
– printing, B-49 – ISE Ref. aspiration filter, C-66
Calibration and QC Select, operation, B-48 – ISE sipper, C-44
Calibration error, ISE unit, D-25 – probes, C-44
Calibration failure data – radiator filter, C-72
– ISE unit, D-10 – reaction cells, C-62
– photometric unit, D-18 – rinse stations, C-55
Calibration Load List report, B-50 – water tank, C-58
Calibration methods, B-119 Cleaning solutions, overview, A-64

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F-4 Operator’s Manual · Version 1.0
cobas c 311 analyzer Index

CmpT.? (data alarm) Cond.E (data alarm), ISE unit, D-26

– ISE unit, D-10 Conditions, safety information, A-7
– photometric unit, D-19 Configuration
CmpT.E (data alarm) – Module Set, B-202
– ISE unit, D-11 – report format, B-214
– photometric unit, D-19 – system configuration, B-191
cobas c pack Confirmation window, B-22
– loading of reagents, B-45 Contact addresses, 3
– reagent loading station, A-46 Containers (cups and tubes)
– Registration, B-104 – on sample disk, A-41
– scanning problems, B-46 – specifications, A-75
cobas c pack MULTI, B-101 Control
– Development Channel applications, B-173 – activate, B-169
– insufficient filling volume, B-45 – edit values, B-168
cobas e-library, A-34 – load, B-51
COBAS INTEGRA cassette, A-46, B-101 – measuring, B-52
cobas link – request, B-49
– backup function, A-32, A-34 – troubleshooting, Photometric unit, D-57
– data station, A-31 – validating, B-53
– e-barcodes, A-32 Control data, A-33
– e-library, A-31, A-35 – loading, B-165
– e-package inserts, A-32, A-34 Control unit
– Essential Information Upload, C-23 – components, A-28
– loading application parameters, B-174 – location, A-23
– loading calibrator data, B-131 – specifications, A-71
– loading control data, B-165 Conventions used in this manual, 8
– Overview, A-31 Cooling fan, A-65
– update process, A-31 – cleaning, C-95
Color scheme Cooling unit, A-63
– Alarm button, B-35 – power switches, A-27
– QC Run Status screen, B-151 – radiator filter, A-63, C-72
– Reagent Overview button, B-111 Copyright, 2
– Reagent Overview window, B-112 Cover
– status icons for units, B-8 – see top cover
– System Overview screen, B-38 Cover, safety information, A-10
– Test Review window, B-90 Cross contamination of samples, A-11
– Test Selection matrix, B-79 Cross contamination, see Carryover
– Workflow Guide area, B-37 Cups and tubes, specifications, A-75
Compensated test Customer information, 8
– formula editing, B-208 Cutouts, for the reagent probe, A-43
– programming, B-207
Compensation error D
– calculation error (ISE unit), D-10
– data error (ISE unit), D-11 Daily Maintenance button, B-40
Components Daily maintenance schedules, overview, C-28
– behind the front doors, A-63 Daily operation
– control unit, A-28 – check system alarms, B-35
– ISE area, A-58 – preroutine, B-40
– overview, A-24 – processing samples, B-57
– reaction disk, A-48 – start processing, B-58
– reagent area, A-43 – starting inspection, B-30
– rear view, A-65 – System Overview screen, B-36
– sampling area, A-36 – workflow, B-29
Computer Data
– control unit components, A-29 – archive patient data, B-89
– troubleshooting, D-45 – calibration, B-125

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Index cobas c 311 analyzer

Data alarms E
– all listed, D-8
– for controls, D-34 e-barcodes, A-32
– ISE unit, D-9 – application data, A-33
– photometric unit, D-17 – calibrator data, A-33
Data monitor report – control data, A-33
– customizing patient reports, B-214 Edited (data alarm)
– monitor format, report format, B-216 – ISE unit, D-11
Data Print, operation, B-69 – photometric unit, D-20
Data problems without alarms, D-38 Editing
Data Review screen, B-88 – control values, B-168
Date format, B-114 – maintenance pipes, C-11
Dead volume, A-75 – maintenance types, C-17
Decreased sample volume, D-41 Edition notice, 2
Deionized water, water supply tube, A-65 Electrical safety, A-8
Det.S (data alarm) Electrical supply, power not available, D-48
– photometric unit, D-20 Electromotive force, ISE analysis, A-61
Detergents e-library, A-31, A-35
– cell wash, A-63 – e-barcodes, A-32
– overview, A-64 – e-package inserts, A-32, A-34
– sample probe, A-36 – introduction, A-34
Development Channel – user interface, A-35
– description, B-173 Emergency stop, E-6
– Reagent Setting screen, B-107 Environmental conditions, A-70
Diluents for photometric tests, B-99 e-package inserts, A-32, A-34
Dilute waste line, A-65 Erratic result
Dilution – ISE unit, D-51
– automatic, B-64 – Photometric unit, D-55, D-57
– from Host, B-64 Erroneous operation, D-38
– manual, B-64 Evaporation of samples, A-11
– prediluted sample, B-64 Expected values
Dimensions, A-69 – changing, B-190
Disk column, Data Review screen, B-88 Expected values, changing, B-190
Disk position (codes N, E, C), B-88 Expiration Date format, B-114
Disposal, A-7
– of control unit components, A-19 F
– of the analyzer, A-19
– of waste, A-9 F1 Help, B-23
Document information, 2 False bottom tube, A-41
Download – settings, B-201
– application data, A-33 – specifications, A-75
– calibration data, A-33 Fatigue due to long hours of operation, A-11
– control data, A-33 Filters
– e-barcodes, A-32 – detergent aspiration filters, C-68
– parameters, B-54 – ISE Ref. aspiration filter, C-66
Drying cylinder – radiator filter, C-72
– reagent probe, A-44 – water filter, C-93
– sample probe, A-39 Flow path
Dup.E (data alarm), photometric unit, D-27 – cleaning, C-40
Duplicate error, photometric unit, D-27 – ISE measuring system, A-60
DVD drive, computer components, A-29 Fuses and circuit breakers, A-12
DVD, specifications, A-71
G
Gate, to the reagent loading station, A-43
Global buttons, B-10

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H – erratic result, D-51

– flow of analysis, A-61
H (data alarm) – introduction, A-25
– ISE unit, D-11 – low values, D-53
– photometric unit, D-20 – reagent compartments, A-60
Hard disk ISE.E (data alarm), D-12
– control unit components, A-29 ISE.N (data alarm), D-13
– saving space on, B-41 IStd.E (data alarm), D-28
Height adjusting lever, A-28, A-29
Help K
– See Online Help system.
High result, Photometric unit, D-54 Keyboard, A-29
High value
– ISE internal standard, D-52 L
– sodium, D-53
Hitachi cups, specifications, A-75 L (data alarm)
Hitachi micro cup, A-41 – ISE unit, D-13
Hitergent, A-50, B-100 – photometric unit, D-21
Host interface, specifications, A-75 L, H, I (serum index), B-189
Light path, of photometer, A-51
I Liquid level detection
– reagent probe, A-44
ICVC (initial cassette volume check) – sample probe, A-39
– registration of cobas c packs, B-104 List boxes, software basics, B-20
INC., abbreviation, 9 Load list
Increased sample volume, D-41 – calibrator and QC load list, B-48
Incubator bath, A-50 – reagent load/unload list, B-42
Incubator bath, see also Reaction bath Loading
Individual QC Chart window, B-153 – application parameters, B-174
Information, where to find, 7 – calibrator data, B-131
Insoluble contaminants in samples, A-10 – calibrators, B-51, B-139
Inspection, before starting-up, B-30 – control data, B-165
Installation of the analyzer, A-6 – controls, B-51
Instrument – routine samples, B-57
– approvals, 3 – STAT samples, B-61
– care, C-30 Low results
– troubleshooting, D-47 – ISE unit, D-53
Insufficient reagent alarm, ISE unit, D-14 – Photometric unit, D-55
Interface port, A-30, A-75 Low values
Interface, Host (specifications), A-75 – chloride, D-53
Internal standard, high/low values, D-52 – ISE internal standard, D-52
Interruption of measurement, B-60 – ISE unit, D-53
Intervals, for replacement of parts, C-39
ISE M
– auxiliary reagents, B-97
– drain port, A-65 Magnetic fields, A-28
– measuring system, A-60 Main components, overview, A-23
– notes for replacement of reagents, B-98 Maintenance
– performing a reagent prime, B-44 – checks, list of, C-24
– replacing reagent bottles, B-42 – general maintenance, C-5
– sipper mechanism, A-59 – instrument care, C-30
ISE reagents – maintenance types, adding and editing, C-17
– replacement of bottles, B-43 – overview, definitions, and concept, C-7
ISE unit – performing items and checks, C-9
– calibration, B-123 – preventive (periodic replacement), C-39
– components, A-58 – recommended intervals, C-28

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Index cobas c 311 analyzer

Maintenance items, C-21 – overview, B-29

Maintenance mode, B-33 – preroutine operation, B-40
– to put the analyzer into, B-33 – preventive action, B-39
Maintenance pipe – processing samples, B-57
– defining, C-11 – safety information, B-3
– editing, C-11 – start measurement, B-58
– pipe and pipe function, differences, C-10 – starting inspection, B-30
– Power ON pipe, C-16 – System Overview screen, B-36
– Power Up Pipe function, C-13 Operator
– recommended maintenance pipes, C-15 – qualifications, A-6
– Sleep pipe, C-16 – troubleshooting responsibility, D-45
– Sleep Pipe function, C-14 Operator’s Manual
– Start Up Pipe function, C-14 – conventions used, 8
– Weekly pipe, C-16 – find information, 7
Maintenance schedules – version, 2
– brief description, C-30 Options, option buttons, B-22
– overview, C-27, C-28 Ordering information, 8
Maintenance switch, B-33 Out of order
Maintenance type – instrument unused for an extended period of time, A-7
– defining, C-17 Over.E (data alarm)
– editing, C-17 – ISE unit, D-14
– indication on System Overview screen, B-40 – photometric unit, D-22
Markings, test selection matrix, B-80 Overview
Measurement – areas and components, A-24
– start processing, B-58 – main components, A-23
Measurement cartridges (ISE), A-60
Measuring calibrators and controls, B-52 P
Mechanical problems, isolation, D-47
Mechanical safety, A-10 P, abbreviation, 10
Menu tabs, software basics, B-17 Page button
Minimum sample volume, A-75 – Utility menu, B-16
Mix.E (data alarm) Parameter Download button, B-54
– ISE unit, D-14 Parameters, system, B-192
– photometric unit, D-22 Pause/Scan (global button), B-10
Modes, of the instrument Periodic replacement of parts, C-39
– explanations, B-32 Personal protective equipment, A-6
– maintenance schedules, C-29 Photometer, A-51
Module Set screen, B-202 Photometric tests
Multiclean, B-100 – configuration, B-173
– troubleshooting, D-59
N Photometric unit
– calibratin failure, D-18
NaOH-D, B-100 – data alarm, Cal.E, D-18
Non-barcode mode, A-42 – flow of analysis, A-54
Non-standard tube – introduction, A-24
– settings, B-201 – reaction course, A-57
Notice, safety classification, A-5 – specifications, A-73
Photometric unit troubleshooting, D-54
O – biased enzyme results, D-59
– biased results, D-57
Online Help system, 8, B-23 – erratic results, D-55, D-57
Operating conditions, A-7 – high results, D-54
– electrical, A-69 – low results, D-55
– environmental, A-70 – troubleshooting control, D-57
– water requirements, A-70 – troubleshooting sample, D-57
Operation – troubleshooting single test, D-58

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Piercer, for cobas c packs, A-44, A-47 QC error 1 (1-3S), D-34

Pinch valve QC error 2 (1-2.5S), D-35
– location, A-59 QC Load List report, B-50
– replace tubing, ISE unit, C-82 QC points
Pipetting volumes, ISE reagent, A-74 – adding comments, B-153
Position – excluding, individual points, B-153
– assign barcoded samples to calibrator positions, B-98 Qualitative fields, photometric application parameters,
– assign calibrators, B-138 B-189
– assign STAT positions, B-194 Quality controls
Position Status – for ISE applications, B-98
– Sample Tracking window, B-66
Power ON R
– order for switching on the analyzer, order, B-31
– troubleshooting, D-47 R4SD (data alarm), D-35
Power ON pipe, C-16 Radiator filter, A-63
Power supply, specifications, A-69 – cleaning, C-72
Power switches, A-27 Random access, E-9
Power Up Pipe function, activating, C-13 Random error, realtime QC, D-35
Pre-diluted sample Reaction bath, A-50, C-62
– requesting a test manually, B-81 Reaction cell, A-48
Prediluted sample, B-64 – rinse unit, A-52
– requesting a test manually, B-81 Reaction course, of photometric analysis, A-57
Prep.E (data alarm), ISE unit, D-29 Reaction disk, A-48
Preroutine operation, B-40 Reaction Monitor
Preventive action – calibration measurements, B-126
– check box, B-39 Reaction system, specifications, A-72
– in daily routine, B-39 Reag.S (data alarm), ISE unit, D-14
Print Reagent
– Automatic Printout, B-52, B-69 – barcode label of cobas c packs, B-102
– customizing report format, B-214 – handling, B-103
– Data Print, B-69 – ISE applications, B-97
– load list, B-48 – loading cobas c packs, A-46
– QC load list, B-149 – notes for replacement of ISE reagents, B-98
– reagent load/unload list, B-42 – photometric applications, B-99
– Report format, B-216 – registration of cobas c packs, B-104
– report name, B-187 – registration of ISE reagents, B-103
– Requisition List, B-57 – replacement of ISE reagents, B-43
Printer, A-30 Reagent area components, A-43
Printout Reagent cassettes
– Sample No. (S. No.), B-88 – reagent compartment, A-43
Processing Reagent compartment, A-43
– reruns, B-62 Reagent load/unload list
– routine samples, B-57 – daily operation, B-42
– STAT samples, B-61 – printing, B-42
Programming Reagent loading station, A-46
– calculated tests, B-204 Reagent management system, A-46
– compensated tests, B-207 Reagent Overview window, B-111
– system parameters, B-192 Reagent pipetting system, A-44
Reagent Preparing button, B-42
Q Reagent prime
– for ISE reagents, B-44
Q2.5SD (data alarm), D-35 Reagent probe, A-44
Q3SD (data alarm), D-34 – does not descend to liquid surface, D-49
QC – programming special washes, B-209
– request, B-49 Reagent storage, location, A-43
– validating, B-53 Reagent syringe, A-45

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– bubbles in, D-50 Routine QC Assign, B-146

Reagent system, specifications, A-73 Rsp1.E (data alarm), ISE unit, D-29
Reagent troubleshooting, photometric unit, D-58 Rsp2.E (data alarm), ISE unit, D-30
ReagEx (data alarm), photometric unit, D-23
Recycling, of the analyzer, A-19 S
Reference cartridge
– ISE measuring system components, A-60 S. Stop (global button), B-10
– periodic replacement, C-101 S10Xa (data alarm), D-37
Registration S10Xw (data alarm), D-37
– cobas c packs, B-104 S1A.E (data alarm), photometric unit, D-30
– ISE reagents, B-103 S2-2Sa (data alarm), D-35
Relocation, A-7 S2-2Sw (data alarm), D-36
Repeat limit S4-1Sa (data alarm), D-36
– changing, B-188 S4-1Sw (data alarm), D-37
Repeat limit (data alarm) Safe and proper use of the analyzer, A-6
– ISE unit, D-15 Safety information
– photometric unit, D-23 – classifications, A-5
Repeat Limit Flag, check box, B-195 – for daily operation, B-3
Replacement – for maintenance, C-3
– cell detergents, B-109, C-69 – general safety information, A-3
– ISE reagents, B-42 – precautions, A-6
– notes for ISE reagents, B-98 Samp.? (data alarm), photometric unit, D-24
– of ISE reagents, B-103 Samp.C (data alarm)
– of parts, intervals, C-39 – ISE unit, D-15
Report – photometric unit, D-24
– customize, B-214 Samp.S (data alarm)
Report name, B-187 – ISE unit, D-15
Reproducibility, poor, D-38 – photometric unit, D-24
Requesting Sample
– calibrations, B-49 – categories of samples, A-41
– controls, B-49 – detergent bottles, A-36
– tests manually, B-81 – identification, A-42
Rerun – loading routine samples, B-57
– automatic rerun settings, B-62 – loading STAT samples, B-61
– decreased/increased volume, B-64 – prediluted, B-64
– diluted sample, B-64 – processing, B-57
– introduction, B-62 – processing additional samples, B-59
– performing manual reruns, B-84 – rerun, B-62
Result data – results, B-65
– at high level, D-39 – tracking, B-66, B-93
– at low level, D-39 – troubleshooting, Photometric unit, D-57
– drifting, D-38 – tubes and cups, A-41
Results – volume for rerun, D-41
– printing individual, B-69 Sample barcodes, unreadable, B-86
– ready for validation, B-65 Sample clogging (data alarm), D-15
Reuse, of the analyzer, A-19 Sample containers, A-41
Review Alarm screen, B-35 – minimum sample volume, A-74
Reviewing calibration measurements, B-126 – specifications, A-75
Revision history, 2 Sample Data Clear, B-41
Rinse station Sample detectors, A-37
– cell rinse unit, A-52 Sample disk, A-37
– cleaning, C-55 – barcode reader, A-37
– reagent probe rinse station, A-45 Sample identification (barcode and non-barcode), A-42
– sample probe rinse station, A-39 Sample No. (S. No.), printout, B-88
Routine operation, B-56 Sample pipetter, A-39
– workflow, B-29 Sample probe, A-36, A-39

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– not descending to liquid surface, D-49 – detailed specifications, A-67

– programming special washes, B-212 – sample containers, A-75
Sample Reception mode, B-70 Spillage, safety precaution, A-11
Sample search, B-93 Stability Timer Reset, B-146
Sample status Standard buttons, B-19
– Data Review screen, B-65 Standard cup, A-41
Sample syringe Standby mode, B-32
– bubbles in, D-50 Start a run, B-58
– location, A-40 Start Conditions screen, B-58, B-59
Sample Tracking window, B-55, B-93 Start Up Pipe function, activating, C-14
Sampling area components, A-36 Start, processing samples, B-58
Sampling stop, B-70 STAT
Screen – positions, A-37
– accessibility, B-9 – processing samples, B-61
– general description, B-7 – request test manually, B-81
Screens, software basics, B-17 Status
SD.E (data alarm), photometric unit, D-31 – icon colors for units, B-8
Selecting Status line (top of screen), B-8
– items on touchscreen, A-29 Statuses, of the instrument
– tests, B-57, B-61 – explanations, B-32
Sens.E (data alarm), photometric unit, D-31 – maintenance schedules, C-29
Sensitivity error, D-31 Std, abbreviation, 10
Serum index Std.E (data alarm), photometric unit, D-33
– check, B-189 Stop (global button), B-10
Shield pipe Stop button
– cleaning, C-45 – interruption of measurement, B-60
– location, A-39 Stop, sampling, B-70
Shortcut keys, B-24 Switching on the analyzer, B-31
Shutdown Symbols, 8
– analyzer, B-71 Syringes
– checks after, B-73 – location, A-40
– order for, B-72 System interface port, A-30, A-75
Shutdown status, B-32 System Overview screen, B-36
Sleep mode, B-71, C-13 – color scheme, B-38
– entering, B-72 – color scheme, Workflow Guide, B-37
Sleep pipe, C-16 – preventive action, B-39
Sleep Pipe function, activating, C-14 System parameters
Slop.E (data alarm), ISE unit, D-32 – how to program, B-192
SMS, B-100 System reagents, see Auxiliary reagents
Sodium System specifications, A-69
– high values, D-53
– ion-selective electrode, A-60 T
Software
– cannot access screen, D-48 Tabs
– general description, B-7 – software basics, B-18
– main menu screens, B-11 Technical limit
– version, 2 – change, B-187
Software elements, B-17 – data alarm, photometric unit, D-16
Software version, determining, C-24 Technical support, calling, D-46
Sound volume adjustment knob, A-63 TeleService Net (TSN), cobas link, A-31
Sound, abnormal, B-30 Test
Spare parts, for maintenance, C-39 – 3rd Results Acceptance, B-195
Special wash, programming, B-209 – assigning a test, B-203
Specifications – assigning to units, B-203
– barcode, A-76 – define automatic rerun, B-187
– basic specifications, A-26 – define report name, B-187

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– request manually, B-81 – buttons, B-18

Test matrix, B-79 – general description, B-7
– markings, B-80 – See also, Software.
Test selection Using Help system, 8
– downloaded from Host, B-57
– for STAT samples, B-61 V
– manual selection, B-81
Test selection matrix Vacuum pump and tank, A-63
– colors, B-79 Vacuum system, A-63
Test Selection screen Validating
– overview, B-78 – calibration, B-53
– test matrix, B-79 – QC, B-53
Text boxes, software basics, B-20 Values
Third-party software, A-7 – edit control values, B-168
Tip water aspiration position, A-39 – expected value ranges, B-189
Top cover, A-50
– description W
– instrument statuses, B-32
– safety information for maintenance, C-3 Wake-up time, C-13
– safety information for operation, B-3 Warning, safety classification, A-5
Touchscreen Waste, A-9
– does not come on, D-49 – container for highly concentrated waste, A-65, C-32,
– hard to see, D-49 C-37
Touchscreen monitor, A-29 Waste solution container, A-65
Tracking samples, B-93 Water leakages, B-30
Trademarks, 2 Water level sensor, reaction disk, A-48, A-49
Transportation, A-7 Water requirements, A-70
Triangles on buttons, B-19 Water supply, A-63
Trouble – tank, A-63
– attributed to characteristics of reagent, D-40 – tube, A-65
– for each test, D-40 Wavelengths, photometric measuring system, A-73
Troubleshooting Weekly pipe, C-16
– application, D-45 Windows
– barcode read error, B-86 – confirmation, B-22
– computer, D-45 – software basics, B-22
– general, D-45 With Automatic Rerun, check box, B-195
– operator’s responsibility, D-45 Work Flow Guide
– Photometric unit, D-54 – color scheme, B-37
– procedures, D-45 – guide through preventive action, B-39
– test, D-46 Workplace menu
Tubes and cups – Data Review screen, B-88
– description, A-41 – Test Selection screen, B-78
– specifications, A-75

U
Ultrasonic mixer, A-49
Unit of measure
– defining and changing, B-186
– for an application, B-186
Unloading
– cobas c pack, B-47
Unreadable sample barcodes, B-86
Updating
– application parameters, B-174
User interface

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Notes H