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143 views330 pages

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Miguel Bautista

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cobas b 221 system

Instructions for Use

COBAS, COBAS B and LIFE NEEDS ANSWERS
are trademarks of Roche.
©2009 Roche Diagnostics

Roche Diagnostics GmbH

D-68298 Mannheim
Germany
www.roche-diagnostics.com
cobas b 221 system

Revision History

Manual Version Software Version Revision date Changes

2.0 1.0 May 2003 Launch
3.0 1.0 June 2003 not delivered
3.1 1.02 July 2003
4.0 2.0 March 2004
5.0 4.0 December 2004
6.0 5.0 November 2005
7.0 5.0 March 2006 cobas Branding
8.0 6.0 December 2006
9.0 7.0 February 2008
10.0 >7.0 April 2009

Edition notice

cobas b 221 system

In the course of 2006 the Roche OMNI S system was relaunched under the
Roche Diagnostics professional IVD user brand cobas®.
Systems with a serial number of 5001 or above are cobas b 221 systems.
Systems with a serial number up to 5000 are Roche OMNI S systems.
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. 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 are done by Roche Service representatives.

© 2009, Roche Diagnostics GmbH, all rights reserved

The contents of this document may not be reproduced in any form or communicated
to any third party without the prior written consent of Roche Diagnostics.
While every effort is made to ensure its correctness, Roche Diagnostics assumes no
responsibility for errors or omissions which may appear in this document.
Subject to change without notice.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 1
cobas b 221 system

Brands

COBAS, COBAS B, LIFE NEEDS ANSWERS, ROCHE OMNI, AUTOQC,

ROCHE MICROSAMPLER, COMBITROL and AUTO-TROL are trademarks of
Roche.

Contact addresses

Manufacturer Roche Diagnostics GmbH

D-68298 Mannheim / Germany
www.roche.com

Edition

Revision 10.0, April 2009

First edition: May 2003
REF/No. 03261395001

Roche Diagnostics April 2009

2 Instructions for Use · Revision 10.0
cobas b 221 system

Table of contents

Revision History 1
Edition notice 1
Operation Part B
Copyright 1
Brands 2 6 Measurement
Contact addresses 2 Preanalytics B-5
Edition 2 Interferences B-10
Table of contents 3 Limitations of clinical analysis B-17
Preface 5 Measuring procedure B-19
How to use this manual 5
Where to find information 5 7 Quality control
Conventions used in this manual 5 Quality control - general B-33
General QC concept B-33
Important information concerning the analysis of QC
Introduction and specifications Part A measurement results B-35
Material setup B-36
1 Safety information QC setup wizard B-44
Important information A-5 QC measurement B-51
Operating safety information A-6 Multirules B-53
QC consequences B-55
2 General descriptions Remove the QC lock B-56
Introduction A-9 QC for Ready (with AutoQC module) B-57
General notes A-11 QC for Ready (without AutoQC module) B-59
Measurement and calibration procedure A-13 QC troubleshooting B-61
Measurement evaluation A-14
Safety instructions for specific dangers A-14 8 Calibration
Handling solutions A-15 Calibration - general B-65
Handling electrodes A-15 Automatic calibrations B-65
General notes on the use of the MSS cassette A-16 User-activated calibrations B-66
System description A-18 Display of parameters during calibration B-68

3 Installation and shutdown 9 Software modes

Installation A-27 Software modes - general B-71
Shutdown A-48 User interface B-71
Analyzer mode B-78
4 Specifications Setup B-80
Performance data A-59 Data manager B-81
Sample throughput A-86 Info B-87
Measurement times of the samples A-86
Sample volumes A-87
Sample types A-87
Maintenance Part C
Calibrations A-88
Environmental parameters A-89 10 Maintenance
Product data A-91 Maintenance - general C-5
AutoQC A-92 Decontamination C-5
Printer A-92 Daily C-7
Touch screen-PC unit A-93 Weekly C-8
Barcode scanner A-94 Quarterly C-9
Sample-dependent maintenance procedures C-13
5 Theoretical foundations Unscheduled C-22
Parameters and calculations A-97 Additional maintenance procedures C-38
Clinical significance A-109

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 3
cobas b 221 system

Troubleshooting Part D

11 Troubleshooting
Troubleshooting - general D-5
System stops D-5
Module stops D-12
System warnings D-16
Status messages of measuring and calibration values
D-20
Status messages on the measurement report D-39
Barcode D-40

Appendix Part E

12 List of consumables
Order information E-5
Glossary E-9

Index Part F

Index F-3

Roche Diagnostics April 2009

4 Instructions for Use · Revision 10.0
cobas b 221 system

Preface

The cobas b 221 system is an analyzer with integrated AutoQC drawer option.
This manual has detailed descriptions of cobas b 221 system features and general
operational concepts, specification functions and use of controls, operating
techniques, emergency procedures, product labeling and maintenance procedures.

How to use this manual

o Keep this manual in a safe place to ensure that it is not damaged and remains available for use.
o This Instructions for Use should be easily accessible at all times.

To help you find information quickly, there is a table of contents at the beginning of
the book and each chapter. In addition, a complete index can be found at the end.

Where to find information

In addition to the Instructions for Use, the following documents are also provided to
assist in finding desired information quickly:
o cobas b 221 system Reference Manual
o cobas b 221 system Short Instruction

Conventions used in this manual

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

Symbols Helping to locate and interpret information in this manual the following symbols are
used:

Symbol Used for

a Procedural step
o List item
e Cross-reference
h Call up of screen

Note

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 5
cobas b 221 system

Symbol Used for

Caution
All sections / passages that are marked with this symbol describe procedures
and/or indicate conditions or dangers that could damage or lead to a
malfunction in the cobas b 221 system, and which therefore should never be
attempted and contain information that must be observed to avoid potential
injuries (to patients, users and third parties).
Risk of infection
All sections and parts of texts that are marked with this symbol describe
procedures that may involve risk of infection.

IVD symbols The symbols are used in accordance with DIN EN 980(a) and DIN EN ISO 780(b).

Symbol Description
Conformité Européenne:
This product complies with the requirements in the guideline for
In Vitro Diagnostic 98/79/EC.

Lot designation

Use by...
The product should not be used after expiry of the specified date.
If a day is not indicated, apply the last day of the respective month.
Temperature limitation
The conditions necessary to preserve the product's shelf life before
opening.

In Vitro Diagnostic Medical Device

Manufacturer
(according to In Vitro Diagnostic guidelines 98/79/EG)

Catalogue number

Serial number (model plate)

Caution, consult accompanying documents

Please consult instructions for use

(a) DIN EN 980: Medical devices - Symbols to be used with medical device labels, labelling and information
to be supplied (Part 1: General requirements)
(b) DIN EN ISO 780: Packaging - Pictorial marking for the handling of goods

Roche Diagnostics April 2009

6 Instructions for Use · Revision 10.0
cobas b 221 system

Symbol Description
Biological risk!
(according to the standard IEC/EN 61010-2-101)(a) (Instrument)

Biological risk!
(according to the standard DIN EN ISO 980)(b) (Consumables)

Do not use if package damaged

Do not reuse

Fragile. Handle with care

Handle with care

Valid only for Roche MICROSAMPLER:

Method of sterilization using ethylene oxide
Valid only for BS2 Blood Sampler:
Method of sterilization using irradiation
(a) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control, and
laboratory use - (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment).
(b) DIN EN ISO 980: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied (Part 1: General requirements).

Other symbols The following symbols are listed as additional information:

Symbol Description
Electrodes:
This date indicates the limit of the maximum storage time of
an electrode. The electrode must be installed in the instrument
no later than the imprinted date.
If the installation takes place on the imprinted date, it still falls
within the specifications. The calculation of the “Install
before” date is based on the production date of the elctrode.
Danger symbol: "Irritant" (on the label and the packaging of
S2 Fluid Pack)
Rating: Although not corrosive, momentary, longer-lasting, or
repeated contact with skin or mucous membrane may result in
inflammation. Danger of sensitization during contact with
skin (when classified with R 43).
Caution: Avoid contact with eyes and skin, do not inhale
vapors.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 7
cobas b 221 system

Symbol Description

Invisible Laser Radiation

Avoid direct radiation to eyes!
Laser Class 3R according to EN 60825-1
P0 ≤ 5 mW
λ = 635 - 850 nm

Store upright

"Grüner Punkt" (in Germany)

Suitable protective equipment, like laboratory clothing, protective gloves, protective

goggles and if necessary mouth protectors, must be worn to prevent direct contact
with biological working materials. In addition, a face mask is required if there is a
risk.

Adjustments and maintenance performed with covers removed and power connected
may be attempted only by a qualified technician who is aware of the associated
dangers.
Instrument repairs are to be performed only by the manufacturer or qualified service
personnel.
Only accessories and supplies either delivered by or approved by Roche are to be used
with the instrument. These items are manufactured especially for use with this
instrument and meet the highest quality requirements.
Operation of the instrument with solutions whose composition is not consistent with
that of the original solutions can negatively affect the long-term measurement
accuracy. Deviations in the composition of the solutions can also decrease the service
life of the electrodes.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each exchange
of solutions and packs and after startup of the instrument.
Additionally complete a quality control test on one level between two automatic 2P
calibrations. The level have to be alternated (low, normal, high).
Since the measurements of the instrument depend not only on the correct
characteristic function, but also on a series of marginal conditions (e.g. pre-analysis),
results obtained from the instrument should be submitted for an expert opinion
before taking additional measures based on the supplied measurements.

Caution (refer to accompanying documents)!

Please refer to safety-related notes in the manual accompanying this instrument.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-5
1 Safety information cobas b 221 system
Operating safety information

Operating safety information

The instrument has been constructed and tested according to the following European
Standards:
o IEC/EN 61010-1
o IEC/EN 61010-2-101
o IEC/EN 61010-2-081 + A1
It was delivered from the factory in flawless condition with regards to safety features.
In order to preserve this condition and ensure safe operation, the user must respect
the notices and warnings that are contained in these Instructions for Use.
o This equipment is a Class I laser product, and it complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J (only valid for
cobas b 221<1> system, cobas b 221<3> system and cobas b 221<5> system with
tHb/SO2 module).
o This instrument is classified under the protection class I according to
IEC /EN 61010-1.
o The instrument meets the conditions for overvoltage category II.
o The instrument meets the conditions for contamination level 2.
o Do not operate the instrument in an explosive environment or in the vicinity of
explosive anesthetic mixtures containing oxygen or nitrous oxide.
o If objects or liquids enter the internal areas of the instrument, remove the
instrument from its power supply and allow an expert to check it thoroughly
before using it again.
o The instrument is suitable for long-term operation indoors.

o The power cord must be plugged into a grounded power receptacle. When using an extension
cord, make sure it is properly grounded.
o Any rupture of the ground lead inside or outside the instrument or a loose ground connection
may result in hazardous operating conditions for the operating personnel. Intentional
disconnection of the grounding is not permitted.
o The instrument is not suitable for operation with a direct current power supply. Use only the
original power plug delivered with the cobas b 221 system.
o The use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.

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A-6 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
Contents

General descriptions

This chapter contains a general description of the instrument, as well as

precautionary measures against special dangers and the proper handling of sensors,
solutions and the MSS cassette.

In this chapter Chapter 2

Introduction .................................................................................................................... 9
General notes ................................................................................................................. 11
Application area ....................................................................................................... 11
Operating instructions ............................................................................................ 11
Important buttons on the screen ............................................................................ 12
Measurement and calibration procedure ..................................................................... 13
Measurement procedure ......................................................................................... 13
Calibration procedure ............................................................................................. 13
Measurement evaluation ............................................................................................... 14
Safety instructions for specific dangers ........................................................................ 14
Handling samples .................................................................................................... 14
Disposal of waste water, bottles, packs, electrodes and the instrument ............... 14
Decontamination .................................................................................................... 14
Handling solutions ........................................................................................................ 15
Handling electrodes ...................................................................................................... 15
General notes on the use of the MSS cassette .............................................................. 16
MSS cassette removed from the measuring chamber ............................................ 16
Incompatible substances ......................................................................................... 16
Inserting the MSS cassette ...................................................................................... 17
System description ........................................................................................................ 18
Visual identification ................................................................................................ 18
Screen/PC unit ......................................................................................................... 19
Printer ...................................................................................................................... 19
Measuring chamber ................................................................................................. 19
tHb/SO2 module ..................................................................................................... 19
COOX module ......................................................................................................... 20
Pumps ...................................................................................................................... 20
Input unit ................................................................................................................. 20

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Instructions for Use · Revision 10.0 A-7
2 General descriptions cobas b 221 system
Contents

Bottle compartment ................................................................................................ 20

Reverse side .............................................................................................................. 21
Power supply ...................................................................................................... 21
Interfaces ............................................................................................................ 22
Barcode scanner ................................................................................................. 23
Warning and identification labels (incl. nameplate) ....................................... 24

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A-8 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
Introduction

Introduction

Figure A-1 cobas b 221 system

The cobas b 221 system is an analyzer with integrated AutoQC drawer option.
Depending on combination and configuration, the following parameters can be
measured in whole blood, serum, plasma, acetate and bicarbonate containing dialysis
solutions and QC materials:
o pH
o Blood gas BG (PO2, PCO2)
o Electrolyte ISE (Na+, K+, Cl–, Ca2+)
o Hematocrit (Hct)
o Metabolite MSS

Urea/BUN - only cobas b 221<6> system

o Total hemoglobin (tHb)

o Oxygen saturation (SO2)
o Hemoglobin derivative COOX (O2Hb, HHb, COHb, MetHb)
o Bilirubin (neonatal)

The following configurations are available:

o cobas b 221<1> system(a) BG, pH, tHb/SO2

o cobas b 221<2> system BG, pH, COOX, Bili
(a)
o cobas b 221<3> system BG, pH, ISE, Hct, tHb/SO2
o cobas b 221<4> system BG, pH, ISE, Hct, COOX, Bili
o cobas b 221<5> system(a) BG, pH, ISE, Hct, MSS, tHb/SO2
o cobas b 221<6> system BG, pH, ISE, Hct, MSS, COOX, Bili
(a) are no longer manufactured or offered.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-9
2 General descriptions cobas b 221 system
Introduction

During the measurement or calibration or other processes, it is possible to conduct

database operations, perform certain settings or call up general information at the
same time.
e For details see Chapter 9 Software modes

The individual, mutually independent software modes are defined as follows:

o Analyzer Measuring, QC measurement, system, calibration,

commonly used functions (quick access)
o Setup Instrument settings
o Database Data about patients, measurements, calibrations, QC, and
the instrument
o Info

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A-10 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
General notes

General notes

Application area

The instrument has been tested for measuring parameters in whole blood, serum,
plasma and dialysis solutions (electrolytes only) and the validity of measurements was
tested accordingly.
In order to achieve accurate measurements of recommended aqueous control
solutions (with regards to deviations from biological samples), choose the proper
components and make the corresponding corrections in the QC measurement mode.
The accuracy of measurement values of undefined aqueous solutions cannot be
guaranteed (e.g. due to the possibility of interfering components and/or missing or
insufficient buffer systems, and/or differences in ionic strength and diffusion
potential when compared to biological samples).

Operating instructions

The cobas b 221 system should be switched on at all times!

If the instrument is switched off for an extended period of time (more than 24 hours),
a shutdown must be performed.
e For additional information, see Chapter 3 Installation and shutdown, section Installation
on page A-27 and Shutdown on page A-48.

Prevent any other liquids from entering the instrument except samples and
QC material at the fill port.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each exchange
of solutions and packs and after startup of the instrument.
Additionally complete a quality control test on one level between two automatic
2P calibrations. The level have to be alternated (low, normal, high).
e For additional information, see Chapter 7 Quality control.

With Software V 6.0 onwards, using cobas bge link, the instrument can be monitored
from one location, any disturbances can be remedied and the analytical quality
monitored.
cobas bge link is a remote monitoring and remote maintenance software for Roche
Point-of-Care analyzers.
e see Figure A-2 on page A-12!

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-11
2 General descriptions cobas b 221 system
General notes

A "Screen sharing" Symbol B "Screen sharing" active

Figure A-2

Confirm the message with [OK] either on the instrument or on the PC. The "screen
sharing" symbol is added in the status line.
To avoid multiple operation of the instrument, the message "Screen sharing active" is
displayed with a yellow background in the error and message window of the
instrument.

As long as the "screen sharing" symbol is displayed in the status line, the service connection is
active. In order to prevent multiple operation of the instrument, no buttons on the screen should be
pressed!

Important buttons on the screen

Buttons Description

"Analyzer" active / inactive

"Database" active / inactive

"Setup" active / inactive

"Info" active / inactive

e For additional information, see Chapter 9 Software modes, section Buttons on page B-76.

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A-12 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
Measurement and calibration procedure

Measurement and calibration procedure

Measurement procedure

PO2: Use of the Clark measurement principle: measurement of current generated by

the reduction of oxygen.
PCO2: Use of the Severinghouse principle: potentiometric measurement of the pH
change in the electrode caused by CO2.
pH- , Na+-,K+-, Ca2+- und Cl- electrodes are potentiometric electrodes. Special
glasses are used as the sensitive element for pH and Na+. The potassium and calcium
membranes contain special neutral carriers. A special ion exchanger is used for
chloride membranes. Calculation of these variables also requires the use of a reference
electrode—a permanently contacted chloride electrode in the cobas b 221 system.
Glucose, lactate: Glucose oxidizes to form gluconolacton using atmospheric oxygen
and the glucose-oxidase (GOD) enzyme, lactate oxidizes to form pyruvate using the
lactate oxidase enzyme.
The generated H2O2 is determined amperometrically by using manganese dioxide/
carbon electrode at 350 mV.
Urea: Urea is broken into ammonia and carbon dioxide through urease. Ammonia
and carbon dioxide react through hydrolysis with physiological pH to form ammonia
or bicarbonate ions. The ammonia ions can be determined using a potentiometrical
ammonia ion-selective electrode. This measurement requires a reference electrode
such as those used in ion-selective electrodes.
tHb/SO2: Light absorption in whole blood is measured at four different wavelengths,
the sample is subjected to light radiation and the dispersed light is also evaluated.
COOX: The hemoglobin derivatives and the total bilirubin (= neonatal) are
determined spectrophotometrically based on the Lambert-Beer law.
Hematocrit: Measurement of the sample's conductivity in the ISE measuring
chamber.

Calibration procedure

tHb and SO2 was calibrated when the instrument was manufactured.

Oxygen (O2): Ambient air and a zero point solution are used to calibrate oxygen.

PCO2, pH, ISE: are calibrated using two solutions mixed under different conditions, thereby avoiding
the gas supply which is required by other instruments.

MSS: The calibration is carried out with four (Glu, Lac) or five solutions (Urea/BUN)
whose weighing concentrations form the basis for measured value determination.

COOX: Determining the hemoglobin derivatives and the total bilirubin (= neonatal) are
carried out spectral-photometrically using a cuvette.

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Instructions for Use · Revision 10.0 A-13
2 General descriptions cobas b 221 system
Measurement evaluation

Measurement evaluation

The validity of the test results from the cobas b 221 system must be carefully
examined by a clinical-medical specialist who will take the patient's clinical condition
into consideration before any clinical decisions are reached based on the test results.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each exchange
of solutions and packs and after startup of the instrument.
Additionally complete a quality control test on one level between two automatic 2P
calibrations. The level have to be alternated (low, normal, high).
e For detailed information, see Chapter 7 Quality control.

Safety instructions for specific dangers

Handling samples

While handling samples, all necessary regulations concerning hygiene must be

observed. Dangerous pathogenic agents could be present.
e For more detailed information, see Chapter 6 Measurement

Disposal of waste water, bottles, packs, electrodes and the instrument

Dispose of waste water, bottles, packs, electrodes and the instrument according to local and/or labor
regulations (biologically contaminated—hazardous waste!).

Decontamination

The purpose of this decontamination is to minimize risk when handling items that
were in contact with biological samples.
Roche recommends following a decontamination procedure in addition to
regulations specific to the laboratory.
These decontamination procedures should be performed periodically to minimize the
risk of infections.

Always wear gloves!

e For more detailed information about decontamination, see Chapter 10 Maintenance

Roche Diagnostics April 2009

A-14 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
Handling solutions

Handling solutions

Store the cobas b 221 system wash/calibrating solutions according to the specified
packaging requirements. The temperature of the solutions should be adapted to the
ambient temperature before use.
The shelf life of the solutions is limited.
Please read the bottle label and the packaging for the correct storage temperature and
the maximum shelf life.

DO NOT FREEZE!
If frozen, the solution's concentration may change and cause calibration errors!
Do not use damaged fluid packs (S2 and S3)! Do not mix the individual components!

e For "Storage specifications", see Chapter 4 Specifications.

Handling electrodes

Store the electrodes according to the packaging specifications.

The shelf life of the electrodes is limited.
Please read the label and the packaging for the correct storage temperature and the
maximum shelf life.

CAUTION! Installation note for the PCO2 electrode

Insert the electrode into the measuring chamber within 5 minutes of opening the ALU-PE
packaging.
A special protective gas atmosphere designed to condition the PCO2 electrode during storage is
found inside the ALU-PE packaging.
This gas atmosphere ensures immediate potential stability during insertion of the electrode into the
measuring chamber and immediate readiness for measuring the first 2 point calibration.
If more than 5 minutes elapse after opening the ALU-PE packaging, the level of gas conditioning
could be lost and the time required for the first-time calibration could be increased.

e For "Storage specifications", see Chapter 4 Specifications.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-15
2 General descriptions cobas b 221 system
General notes on the use of the MSS cassette

General notes on the use of the MSS cassette

For instrument versions with MSS module only!

Attention:
MSS cassette may only be brought into contact with liquids in the cobas b 221 system while
electrodes are changed!
Replace the MSS cassette within 28 days of installation!

After initial contact with liquids, the MSS cassette may no longer be removed from the instrument.
It may lead to the destruction of the enzyme sensors.
Storage:
At 2 – 8 °C, maximum of 2 weeks at room temperature.

MSS cassette removed from the measuring chamber

Once an MSS cassette is exposed to liquid, it must not be allowed to dry out under
any circumstances since this would destroy the enzymes. The enzymes are equipped
with a special protectant prior to shipping for transportation purposes. This
protectant is washed out inside the instrument during the warm-up phase and MSS
polarization.

Incompatible substances

The following substances may not be introduced into the MSS measuring chamber
under any circumstances since they would immediately destroy the MSS sensors or
severely impact their functionality.
o Deproteinizer (NaOCl)
o O2 zero point solution
o Cleaning solution
o Na electrode conditioning solution
o Rinse additive
o Solutions containing heavy metals (Ag, Hg, Au, etc., e.g. Thiomersal)
o Cleaning solutions containing detergent (e.g. washing material or liquid
detergents)
o All solutions for disinfections (e.g. high-percentage alcohol, glutaric dialdehyde,
cresol, etc.)
o Solutions with pH values that deviate greatly from neutral
(e.g. pH value of < 6.0 and > 9.0)
The use of anticoagulants other than those approved by Roche Diagnostics
(approved: heparin salts), such as EDTA, citrate, NH4 heparin and glycolysis
inhibitor such as NaF and oxalate can lead to erroneous results.

Roche Diagnostics April 2009

A-16 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
General notes on the use of the MSS cassette

Inserting the MSS cassette

Hold the MSS cassette only at the designated handle and avoid touching the contacts.

e For a detailed description see Chapter 10 Maintenance, section Changing the MSS cassette
(cobas b 221<5> system and cobas b 221<6> system only) on page C-32.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-17
2 General descriptions cobas b 221 system
System description

System description

Visual identification

For example: cobas b 221<6> system

A
O

B
M
L

C K
D

F G H I

A Screen/PC unit G S1 Rinse Solution M Input unit

B Reverse side H S2 Fluid Pack N Measuring chambers
C Docking mechanism I S3 Fluid Pack O Printer
D AutoQC drawer J Bottle compartement cover P Pumps
E Barcode scanner K Bottle compartement
F W Waste container L COOX module (tHb/SO2 module)

Figure A-3 cobas b 221<6> system

Roche Diagnostics April 2009

A-18 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
System description

Screen/PC unit

The screen/PC unit serves as the graphical user interface.

All information (results, error messages, alarms, warnings, etc.) is displayed on the
screen. The screen consists of a color LCD that is covered with a touch-sensitive film
("touch screen").

As sharp objects can damage the touch-sensitive film, only touch the film using suitable pins and/or
with your fingers.

The screen/PC unit also contains a diskette drive.

Printer

Low-noise thermoprinter with integrated paper cutter (manually activated using the
"Cut" key) and optional winder.
The "Feed" key feeds in the paper.

With an installed winder, the "Automatic Cut" function is deactivated.

Measuring chamber

Underneath the top cover are the BG and, depending on the configuration, ISE
measuring chamber with the electrodes, the MSS measuring chamber with the MSS
cassette and the tHb/SO2 or COOX module.
The electrodes are flow-through electrodes with a visible sample channel.

tHb/SO2 module

Figure A-4 tHb/SO2 module

The tHb/SO2 module is an optical sensor module for determining the level of total
hemoglobin (tHb) and oxygen saturation (SO2) in whole blood.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-19
2 General descriptions cobas b 221 system
System description

COOX module

The COOX module consists of the hemolyzer and the COOX measuring chamber.
The measurement is based on the principle of spectral photometry.

Pumps

Depending on the configuration, up to three peristaltic pumps transport the sample

and the operating fluids inside the instrument.

Input unit

The sample insertion as well as the aspiration of solutions is carried out via input unit
which consists of the following:
o T&D module:
o T&D disk
o T&D tubing set with wash-water jet
o Plug control
o Fill port
o Sample drip tray

Bottle compartment

Behind the bottle compartment cover are the S1 Rinse Solution bottle, the
S2 Fluid Pack, the W Waste Container and, depending on the configuration,
S3 Fluid Pack (cobas b 221<5> system and cobas b 221<6> system only).

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cobas b 221 system 2 General descriptions
System description

Reverse side

A D

A Power supply D Air filter

B Main power switch and connector E Interfaces
C Warning and identification labels

Figure A-5 Reverse side

Power supply
This unit also contains the main power switch and the connector.

B C
A

A Power supply
B Main power switch OFF
C Main power switch ON

Figure A-6 Power supply

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2 General descriptions cobas b 221 system
System description

Interfaces
Only data processing units manufactured according to the standards IEC 950
(UL1950) may be attached to the interface connections!

A B C D E F

A Power supply D Ext. keyboard/barcode scanner

B Service connector E RS 232
C RS 232 F 10BaseT

Figure A-7 Interfaces (without USB)

A B C D E F

A Power supply D RS 232

B Service connector E USB
C Ext. keyboard/barcode scanner F 10BaseT

Figure A-8 Interfaces (with USB)

o Variant 2:
2x RS 232 interfaces (COM 1 and COM 2) (SN < 1500)
e see Figure A-7 on page A-22
o Variant 1:
1x RS 232 interface (COM 1) and 1x USB (SN > 1500)
e see Figure A-8 on page A-22
o 1x 10BaseT Ethernet (RJ45)
o Ext. keyboard / barcode scanner: PS/2 DIN - 6 pin female connector
o 1 service connector
o Power (power supply is connected)

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Installation

Installation

Location

For best results, a suitable, level location that is not subject to direct sunlight is
required for the instrument.
When installing an instrument that was stored in a cool room or was transported at
low temperatures, be aware that condensation may have formed and could cause
disturbances to the instrument. The instrument must be climatized at room
temperature for at least one hour before beginning operation.
The following conditions must be fulfilled:
o Ambient temperature: 15 °C to 31 °C
o Ambient air pressure: 797 - 526 mmHg (106.225 - 70.13 kPa)

From approx. 3000 m above sea level or air pressure < 526 mmHg (70.13 kPa), the specifications
for parameter PO2 are no longer fulfilled and the parameter must no longer be used for evaluation
of the clinical decisions.
After successful installation, the parameter must be permanently deactivated.

e See section 23. Checking the barometer value on page A-47

o Avoid direct sunlight, vibration and strong electromagnetic fields (electric

motors, transformers, X-ray equipment, cellular phones...).
o A stable and level work surface (max. 1° incline with bottles installed)
o Relative humidity: 20 to 85%
o At least 10 cm free space around the instrument for air circulation and electrical
connections
o Correct voltage: 100 to 240 VAC (±10%)
After setting up the cobas b 221 system at a location that meets the necessary
conditions, the following steps must be performed to ensure the instrument is ready
for operation:
o First check the instrument and the accessories for completeness and damage. The
completeness of the delivery can be checked through comparison with the delivery
packing slip.
If anything is missing, inform the Roche representative immediately.
If the delivery has suffered damage despite careful packing, inform the transportation
company immediately. Retain the packing material and products as evidence for the
damage claim.

Handle the instrument only at the specified holding points — risk of injury!
Take care when lifting - weight of the instrument without wash/calibrating solutions and AutoQC
is approx. 45 kg!

e See illustration on the outer packaging and in Chapter 4 Specifications, section Holding
points on page A-92!

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3 Installation and shutdown cobas b 221 system
Installation

Accessories

The following parts are delivered as standard equipment with the cobas b 221 system:
o 1 barcode scanner
o 2 Power cords (US and European version)
o 1 roll printer paper
o 2 pcs fill port
o 1 sample inlet path (glass tube)
o 5 system disks
o 1 RCon (reference contact)
o 1 shutdown kit
o 1 dummy electrode
o 1 dummy MSS cassette
o 2 SCon (sensor contact)
o 1 13 mm wrench (for screen/PC unit)
1 Phillips screwdriver
o 3 pump tubes

Not shown in Figure A-12 on page A-29:

o 1 screen/PC unit
o 1 power supply
o 1 fill port
o 2 system disks

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Installation

B
C L

E
K

G
I

A 1 Roll printer paper G 2 Power cords (US and European version) K 1 Fill port
B 1 Dummy electrode H System disks (total of 5 pcs.) L 3 Pump tubes
C 1 Dummy MSS cassette I 1 13 mm wrench (for screen/PC unit); M 1 Shutdown kit
D RCon (reference contact) 1 Phillips screwdriver
E SCon (sensor contact) J 1 Barcode scanner
F 1 Sample inlet path (glass tube)

Figure A-12 Accessories

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3 Installation and shutdown cobas b 221 system
Installation

Installation

1. Screen/PC unit

Ensure that the printed serial number on the rear of the screen/PC unit is the same as the unit serial
number on the nameplate!

1 Unscrew the fixing nut from the screen.

2 Place the screen/PC unit on the swivel arm.
3 At the base of the swivel arm, place the brake packet and lock nut on the shaft and
tighten using the 13 mm wrench provided in the accessories.

C
D

A Screen/PC unit C Fixing nut

B Swivel arm D Brake packet

Figure A-13 Swivel arm of the Screen/PC unit

4 Connect the cable to the screen and push it into the cable routing bar.

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Installation

2. Power supply
1 Place the power supply, including the two adapter connectors, on the holder and
position them.

B B

A Screw B Holder

Figure A-14 Power supply

2 Tighten the screw.

3. Attach power cord and barcode scanner

1 Connect the power cord.
2 Connect the barcode scanner, and, if necessary, the network connection to the
appropriate port on the rear side of the cobas b 221 system.

4. Switch on
o Switch the instrument on and wait until the program has completely loaded and
started. Before starting the installation, you must set the language, in which the
unit is to be operated, the date and the time.

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3 Installation and shutdown cobas b 221 system
Installation

5. Installation
When carrying out the installation, follow the on-screen instructions.

Installation must be carried out completely and may not be interrupted.

Observe the listed sequence while performing the actions.
If the automatic first installation is unsuccessful, you must carry out the installation process
manually. To do this, press the following buttons:
[System] > [Utilities] > [Installation]

Processing the actions

Manual The corresponding line of the list box contains an instruction which must be
performed manually. Then press [Confirm action].

Automatic If there is an automatic sequence for any action, you can start this by clicking
[Start process].

If an action has been completed successfully (manually or automatically),

this symbol is displayed.

6. Select language
1 Press the following buttons:
h Setup > Instrument > Language

If the current language is "English": [Instrument] > [Language]

2 Select the language.

7. Set the date and time

o Press the following buttons:
h Setup > Times & Intervals > Act. time / date

Figure A-15 Act. time / date

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Installation

8. Cal. intervals & timing

o Press the following button:
h Setup > Times & intervals > Cal. intervals & timing

Figure A-16 Cal. intervals

Use this function to enter the automatic calibration times and intervals for system,
1 point and 2 point calibrations.
The time scale uses markers to show the selected interval for the 2P calibration
and the start time for the system calibration.

Intervals:

System calibration Every 8, 12 or 24 hours.

Enter the [Start time] of a system calibration to which all calibrations are oriented.

2P calibration Every 4, 8 or 12 hours.

1P calibration All 30 or 60 minutes (USA: only every 30 minutes).

9. Set valves for FMS(a) tubing exchange

o Press [Start process]. This action is performed automatically.

Valve V19 is pushed in to prevent the tube from being pinched while the aluminum part is
tightened! Valve VM is pushed out.

(a) "Fluid Mixing System" - Mixing of calibration solution A and B in a certain ratio

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Installation

10. Fix screws at V19 (bottle compartment)

1 Open the bottle compartment cover and the docking mechanism "S3".
2 Tighten the screws on valve V19 (approx. 2-3 rotations).
e see Figure A-17!

Use the delivered screwdriver!

A A

A Screws on valve V19

Figure A-17 Valve V19 and VM

3 To return to the installation window, close the docking mechanism and the bottle
compartment cover.

11. Insert right FMS tube at VM (bottle compartment)

1 Open the bottle compartment cover and the docking mechanism "S3".
2 Slide the tube under the tube clip of valve VM.

A B

A VM B V19

Figure A-18 Valve VM

3 Close docking mechanism and bottle compartment cover.

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Installation

12. Insert fill port and sample inlet path (glass tube)
1 Pull out the sample drip tray.
2 Remove the T&D cover and the unit cover.
3 Insert the fill port started from the 6 o’clock position as shown below.
4 Push the fill port straight onto the insert needle.

Do not bend the insert needle during this process!

A Needle

Figure A-19 Insert needle

5 Rotate the fill port 90° clockwise and upwards until it snaps into place.

Figure A-20

6 Open the T&D lock.

e see Figure A-21 on page A-36, A

7 Insert the glass tube into the guides, fasten it and check it for a correct position.
e see Figure A-21 on page A-36, C
e see Figure A-21 on page A-36, D

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Installation

B
C

C
D

A T&D lock C Insert the glass tube into the guides

B Glass tube D Fasten and check for correct position

Figure A-21 Glass tube

8 Close the T&D lock again. Check the correct positioning of the sample inlet path
to the bypass nipple (see below)!

A Bypass nipple

Figure A-22 T&D lock

9 Close the T&D cover.

10 Insert the sample drip tray.

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Installation

13. Insert printer paper

The printer paper is heat sensitive on one side only. Observe the correct insertion of the thermal
paper roll.

A Printer cover B Paper lid

Figure A-23 Printer

1 Open the printer cover and the paper lid.

2 Cut the start of the paper so that it is straight.
3 Place the paper roll into the holder.
4 Make sure that the printer lever is in the "down" position (see below).

A Printer lever "down" position

Figure A-24 Printer lever

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Installation

5 Insert the beginning of the paper according to the instructions on the inside of the
paper lid (see below).

A
B

A Paper lid B Printer lever

Figure A-25 Insert printer paper - without take-up unit

Figure A-26 Insert printer paper - with take-up unit (optional)

6 The paper is automatically pulled into the printer.

7 Close paper lid.

With take-up unit (optional)

1 Press the paper feed button until the paper is long enough.
2 Insert the beginning of the paper in the take-up unit according to the instructions
on the inside of the paper lid.
e see Figure A-26 on page A-38

Press the take-up unit (rods) fully onto the holder and rotate until the paper is taut on the rods and
paper lid, so that the entire roll of paper can be taken up. During operation, the paper should be
tautened now and then by turning the take-up roller.

3 Close printer cover.

With an installed take-up unit, the "Automatic Cut" function is deactivated.

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Installation

14. Insert peristaltic pump tubes

1 Open the peristaltic pump's clear plastic cover (tension lever).
2 Push the linear bracket (white plastic part) upwards (see below).

A Tension lever
B Pump head
C Linear bracket

Figure A-27 Peristaltic pump

3 Place the tubing set around the corresponding rolling wheel (see below/A). Check
that the tubing set is correctly orientated (the grip end must be pointing upwards,
see below/B).
4 Close the clear plastic cover (tension lever). The tubing holder is then pressed into
the sealer (see below/B).

A Place the tubing set B Close the tension lever

Figure A-28 Peristaltic pump

AutoQC module (option)

The installation with an AutoQC module (optional) must be performed by a Roche Diagnostics
Service Representative!

15. Go to AutoQC service position

o Press [Start process]. This action is performed automatically.

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3 Installation and shutdown cobas b 221 system
Installation

16. Open the AutoQC drawer and remove the AutoQC valve clamp
1 Pull out the AutoQC drawer.
2 Pull the key of the AutoQC valve up and out (see below).

A AutoQC valve clamp

Figure A-29 AutoQC valve clamp

3 Close the AutoQC drawer.

17. Go to AutoQC home position

o Press [Start process]. This action is performed automatically.

18. Open AutoQC drawer and insert ampoule holder

1 Pull the AutoQC drawer out again.

A without ampoule holder B with ampoule holder

Figure A-30 AutoQC drawer

2 Insert the AutoQC ampoule holder.

3 Close the AutoQC drawer.

19. Open the measuring chamber cover and insert the sensors

a BG / ISE measuring chamber

1 Open the measuring chamber cover (push the right edge of the MC cover to the
left with a finger and open up the MC cover).

In each case, open only the relevant measuring chamber.

Keep the bottle compartment cover closed.

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Installation

The following screen appears:

Figure A-31 Changing of electrodes

2 Open the locking lever.

e see Figure A-34 on page A-42

3 Follow the instructions on the screen.

Check the internal electrolyte of the electrodes for possible air bubbles (see below).
If there are air bubbles between the contact pin and the membrane, there will not be effective
electrical conduction. Result: calibration and measurement errors!

4 Remove any air bubbles.

Remove air bubbles by holding the electrode vertically and by tapping lightly with
a fingernail against the electrode body (see below).

A Free of air bubbles!

Figure A-32 Electrode

5 Insert the electrodes, beginning at the right and proceeding left according to the
color code.
6 Push all electrodes slightly to the right so that they are lined up together without
gaps.

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3 Installation and shutdown cobas b 221 system
Installation

a Insertion of the reference electrode

1 Insert the reference electrode.

Figure A-33 Reference electrode

2 Insert the reference tube into the upper tube guide channel of the left locking lever
and into the tube holder of the cover hinge. Close the locking lever (see below).

A Locking lever

Figure A-34 Insertion of the reference electrode

3 Connect the white connector on the end of the tube to the measuring chamber
cassette (see below).

A Connector B Measuring chamber cassette

Figure A-35 Insertion of the reference electrode 2

4 Scan the barcodes located on the inner packaging of each electrode or enter the
barcodes manually with the help of the keyboard.
5 Close the measuring chamber cover.

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Installation

a MSS measuring chamber (for instrument versions with MSS module only)

Hold the MSS cassette only at the designated handle and avoid touching the contacts.

1 Open the cover of the MSS measuring chamber (apply force to the right edge of
the MC cover with a finger to push it to the left and open up the MC cover).

Keep the bottle compartment cover closed!

2 Open the contact clip and the locking lever.

3 Depending on the MSS parameter configuration, insert the MSS reference
electrode (Ref + dummy) (see Figure A-36/A) or the reference contact (RCon)
(see Figure A-36/B) and the MSS cassette, close the contact clip and the locking
lever.

A B

A Ref + dummy (for Glu/Lac/Urea) B RCon (Glu or Glu/Lac)

C Locking lever
D Contact clip

Figure A-36 MSS measuring chamber

4 Read in the barcode of the packaging.

5 Close the measuring chamber cover.
6 Close the top cover.
7 Prepare a syringe or capillary with whole blood for polarization. Having
completed the installation process, the unit requests a blood sample.

The blood should have a volume of at least 150 μL, contain heparin as an anticoagulant, and be
stored for less than 24 hours.

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Installation

20. Open bottle compartment cover and insert Waste container & packs

A
A

A Ruber sealings B cobas b 221<5> system and

cobas b 221<6> system only

Figure A-37 Waste container & packs

1 Open the bottle compartment cover.

2 Open the corresponding docking mechanism.
3 Insert an empty waste water bottle and a S1 Rinse Solution bottle.

Remove packs’ rubber sealings.

4 Push the two packs into the appropriate location in accordance with the labeling
on the docking mechanisms until the packs lock.
Using the transponder attached to the bottle/packs, the instrument automatically
recognizes the corresponding bottle or packs.

A cobas b 221<5> system and cobas b 221<6> system only

Figure A-38 Changing of bottles and packs

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Installation

A cobas b 221<5> system and cobas b 221<6> system only

Figure A-39 Bottle compartment

5 Close the docking mechanism and the bottle compartment cover.

To avoid splashing the S1 Rinse Solution, deaerate the bottle at about 3000 m above sea level or
higher before inserting it.

6 Place the bottle tool on the screw cap of the S1 Rinse Solution (see below).

A Bottle tool B Screw cap with placed bottle tool

Figure A-40 Screw cap

7 Press the grips together and press the transparent disk downward (see below/A).
8 Rotate the transparent disk clockwise and stop when you notice a resistance after a
short distance (see below/B).

A B

Figure A-41 Open bottle

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Installation

21. Complete installation

1 Press the [Complete installation] button.
Automatic sequences take place and the unit warms up.
2 Installation is complete.

If a power failure occurs during installation, the installation starts anew with the next restart.
Actions which were performed successfully are discarded.

22. Perform MSS polarization (cobas b 221<5> system and cobas b 221<6> system only)
1 Prepare a syringe or capillary with whole blood for polarization.

The blood should have a volume of at least 150 μL, contain heparin as an anticoagulant, and be
stored for less than 24 hours.

Figure A-42 MSS polarization

2 The blood sample is inserted via fill port similar to a measurement.

e see Chapter 6 Measurement

3 The MSS cassette is subsequently exposed to liquid, polarized and heated.

4 A system calibration is carried out.
5 If, after inserting the cassette, the automatic polarization was not successful and
the MSS sensors are not calibrated, you must manually polarize the MSS cassette.
To do this, press the following buttons:
h System > Utilities > MSS polarization
6 Follow the instructions on the screen!

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Installation

23. Checking the barometer value

h System > Component test > Control sensors > Baro sensor
1 If the barometer value deviates by more than ± 4 mbar from the value indicated by
a precision barometer, it will be necessary for Technical support to calibrate the
barometer!

A wrong barometer value leads to wrong PO2 measurement results.

Important:
From approx. 3000 m above sea level or air pressure < 526 mmHg (70.13 kPa), the specifications
for parameter PO2 are no longer fulfilled and the parameter must no longer be used for evaluation
of the clinical decisions. The parameter PO2 must be permanentely deactivated.

2 To deactivate the parameter PO2 press the following buttons:

h Setup > Parameter > Miscellaneous settings > Activated / deactivated for calibrations

24. Quality control

1 Define the material and if an AutoQC drawer (option) is available insert the mats
before performing a quality control measurement.
e For details, see Chapter 7 Quality control

2 Perform quality control tests for all 3 levels (low, normal, high). Make sure that
the results agree with the target values.
e See Chapter 7 Quality control

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3 Installation and shutdown cobas b 221 system
Shutdown

Shutdown

Less than 24 hours

If the cobas b 221 system is not used for a short period of time only (< 24 hours), then
activate the following function, starting with the top level of the analyzer mode:
h System > Utilities > Shutdown PC
This function allows for switching off the touch screen/PC unit and is completed with
manually switching off the instrument.
Follow the instructions on the screen!

MSS sensors (Glu / Lac / Urea/BUN) are destroyed during this operation.
If the instrument is turned on again, a new MSS cassette must be inserted.

e See section 19. Open the measuring chamber cover and insert the sensors on page A-40.

Longer than 24 hours

If the cobas b 221 system will be shut down for longer than 24 hours, perform the
following procedure.

Before performing a shutdown, Roche Diagnostics recommends decontaminating all surfaces and
tube paths.

e see Chapter 10 Maintenance, Abschnitt Decontamination on page C-5!

Activate the following function, starting with the top level of the analyzer mode:
h System > Utilities > Put out of operation

All solutions and electrodes have to be removed during the shutdown procedure.
The procedure ends in switching off the instrument.
Follow the instructions on the screen.

Observe the listed sequence while performing the actions.

Processing the actions:

Manual: The corresponding line of the list box contains an instruction which must be
performed manually. Then press [Confirm action].

Automatic: If there is an automatic sequence for any action, you can start this by clicking [Start
process].

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Shutdown

Upon successful completion, this symbol is displayed.

1. Open bottle compartment cover and only remove bottle S1 and packs
(depending on the configuration S2 and S3).
1 Open bottle compartment cover and docking mechanism and remove bottle S1
and the packs (S2 and S3).

Do not remove the waste container!

2 Close docking mechanism and bottle compartment cover.

2. Fill the shutdown kit with distilled water

o Fill the shutdown kit about halfway with distilled water.

Figure A-43 Shutdown kit

3. Insert shutdown kit into space S2

1 Open bottle compartment cover and docking mechanism S2 and insert the
shutdown kit into space S2.
2 Close docking mechanism and bottle compartment cover.
3 Perform "Washing of the tubes".

4. Remove shutdown kit from space S2

1 Open bottle compartment cover and docking mechanism S2 and remove the
shutdown kit.
2 Close docking mechanism and bottle compartment cover.
3 Perform "Emptying of the tubes".

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Shutdown

5. Insert shutdown kit into space S3 (cobas b 221<5> system and cobas b 221<6> system only)
1 Open bottle compartment cover and docking mechanism S3 and insert the
shutdown kit into space S3.
2 Close docking mechanism and bottle compartment cover.
3 Perform "Washing of the tubes".

6. Remove shutdown kit from space S3 (cobas b 221<5> system and cobas b 221<6> system only)
1 Open bottle compartment cover and docking mechanism S3 and remove the
shutdown kit.
2 Close docking mechanism and bottle compartment cover.
3 Perform "Emptying of the tubes".

7. Remove Waste container

1 Open bottle compartment cover and docking mechanism W.
2 Remove the waste water container (W Waste Container).
3 Close docking mechanism and bottle compartment cover.

8. Open the measuring chamber cover and remove the sensors

1 Remove the top cover and open all measuring chamber covers.
2 Open the measuring chamber cover (push the right edge of the MC cover to the
left with a finger and open up the MC cover).
3 Open the locking levers and the contact clip (MSS measuring chamber).
4 Sequentially remove the electrodes and the MSS cassette from the measuring
chambers.
5 Close the locking lever, the contact clip and all the measuring chamber covers.

9. Remove the peristaltic pump tubes

1 Open the peristaltic pump's clear plastic cover (tension lever) (see below).

A Tension lever
B Pump head
C Linear bracket

Figure A-44 Peristaltic pump

2 Push the linear bracket (white plastic part) upwards (see below/A).

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3 Remove the complete tubing set (tubing holder and tubing) of the corresponding
pump (see below/B)

A Push the linear bracket upwards B Remove the tubing set

Figure A-45 Peristaltic pump

4 Close the tension lever.

10. Remove the printer paper

1 Open the printer cover and the paper lid.

A Printer cover B Paper lid

Figure A-46 Printer cover / paper lid

2 Move the printer lever upwards (see below/A).

A Printer lever "upwards" B Printer lever "down"

Figure A-47 Printer lever

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3 Remove the printer paper.

4 Move the printer lever down again (see above/B).
5 Close the paper lid and the printer cover.

11. Open T&D

o Press [Start process]. This action is performed automatically.
The T&D disk turns to position 1.

12. Remove fill port and sample inlet path (glass tube)
1 Remove the sample drip tray.
2 Remove the T&D cover.
3 Open the T&D lock and remove the sample inlet path (glass tube).

A T&D lock B Sample inlet path (glass tube)

Figure A-48 T&D lock & sample inlet path

4 Turn the fill port downward by 90° and pull it straight off of the needle.

Do not bend the needle!

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B
A

A Fill port B Needle

Figure A-49 Fill port

5 Close the T&D lock again.

6 Close the T&D cover.

13. Set valves for FMS tubing exchange

o Press [Start process]. This action is performed automatically.

Both valves are pushed out.

14. Release screws at V19 (bottle compartment)

1 Open the bottle compartment cover and the docking mechanism S3.
2 Loosen the screws (A) of the aluminum part of valve V19 (approx. 2-3 turns).

A A

V 19

A Screws

Figure A-50 Valve V19

3 Close the docking mechanism S3 and the bottle compartment cover.

15. Remove right FMS tube at VM (bottle compartment)

1 Open the bottle compartment cover and the docking mechanism S3.
2 Slide the tube out under the tube clip of valve VM.

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A VM B Tube clip

Figure A-51 Valve VM

3 Pressure is removed from the tubes.

4 Close the docking mechanism and the bottle compartment cover.
If available (option):

16. Go to AutoQC home position

o Press [Start process]. This action is performed automatically.

17. Open the AutoQC drawer and remove the ampoule holder
1 Pull out the AutoQC drawer.
2 Remove the AutoQC ampoule holder.
3 Remove the already opened ampoules from the mats and dispose of them
according to the local guidelines.

If individual ampoules remain in the white ampoule holder after removing the mats, note that
these open ampoules may break on removal with the attendant risk of injury.
Before inserting a new mat remove them all carefully!
Always wear gloves! CAUTION: Danger of spilling!

4 Leave the full ampoules in the mats and store them in a refrigerator in accordance
with their storage temperature (see packaging insert).
5 Close the AutoQC drawer.

18. Go to AutoQC service position

o Press [Start process]. This action is performed automatically.

19. Open AutoQC drawer and insert the AutoQC valve clamp
1 Pull out the AutoQC drawer.
2 Insert the clamp of the AutoQC valve (see below).

Roche Diagnostics April 2009

A-54 Instructions for Use · Revision 10.0
cobas b 221 system 3 Installation and shutdown
Shutdown

A AutoQC valve clamp

Figure A-52 AutoQC valve clamp

3 Close the AutoQC drawer.

Performance data

Measurement parameters

Parameter specified for specified range

PO2 B/Q 0 - 800 mmHg
PCO2 B/Q 4 – 200 mmHg
pH B/Q/S/PF 6.0 - 8.0
Sodium B/Q/S/A/D 20 - 250 mmol/L
Potassium B/Q/S/A/D 0.2 - 20 mmol/L
Chloride B/Q/S 20 - 250 mmol/L
ionized Calcium B/Q/S/A/D 0.1 - 4.0 mmol/L 0.4008 - 16.032 mg/dL
Hct B/Q 10 – 80 %
(a) (cobas b 221<5> system,
Glucose B/Q/S 0.5 – 40 mmol/L 9.01 - 720.8 mg/dL
cobas b 221<6> system only)
Lactate (cobas b 221<5> system, B/Q/S 0.2 – 20 mmol/L 1.8016 - 180.16 mg/dL
cobas b 221<6> system only)
Urea (cobas b 221<6> system only) B/Q/S 0.5 – 30 mmol/L 3.0028 - 180.168 mg/dL
tHb module B/Q 3 – 25 g/dL 1.8606 - 15.505 mmol/L
SO2 module B/Q 50 – 100 %
tHb (COOX) B/Q 3 – 25 g/dL
SO2 (COOX) B/Q 0 – 100 %
HHb (COOX) B/Q 0 – 100 %
COHb (COOX) B/Q 0 – 100 %
O2Hb (COOX) B/Q 0 – 100 %
MetHb (COOX) B/Q 0 – 100 %
Bilirubin (neonatal) (COOX) B/Q 3 - 50 mg/dL 51.3 - 855 μmol/L
Baro 450 - 800 mmHg
Table A-1 Measurement parameters
(a) Due to the current specifications, clinically significant deviations in the range < 3mmol/L can occur compared to other glucose measuring systems.
Especially in the neonatal field, we therefore recommend carrying out a comparative blood measurement relative to a known reference system or to
adapt the correlation table (refer to the Reference Manual, chapter "Setup" section "Correlation"). For any questions concerning this matter, contact
the local Roche organization.

B Whole blood
Q Aqueous QC material(a)
A Dialysis solutions containing acetate
D Dialysis solutions containing bicarbonate
S Serum or plasma
PF Pleural fluid (can be measured in serum/plasma mode)
(a) with approximate physiological ion matrix and buffer capacity

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-59
4 Specifications cobas b 221 system
Performance data

Reproducibility

COHb 11.1 0.1265 1.14 0.1306 1.18
MetHb 6.0 0.0577 0.96 0.0671 1.12
HHb 8.6 0.1001 1.17 0.1041 1.21
Bili 12.4 0.0857 0.69 0.1188 0.96
Table A-11 AUTOTROL PLUS B Level 2, n=40

Material: AUTOTROL PLUS B Level 3, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 7.571 0.0027 0.04 0.0050 0.07
PCO2 20.3 0.3114 1.53 0.5568 2.74
PO2 144.2 5.3745 3.73 6.5040 4.51
Sodium 158.9 0.5680 0.36 0.8495 0.53
Potassium 6.97 0.0343 0.49 0.0514 0.74
Chloride 119.0 0.4810 0.40 1.0305 0.87
ionized Calcium 0.546 0.0041 0.76 0.0078 1.43
Hct 26.9 0.4193 1.56 0.4298 1.60
Lactate 0.8 0.0103 1.29 0.0562 7.02
Glucose 21.0 0.1298 0.62 0.4006 1.91
Urea 2.1 0.0202 0.94 0.0757 3.53
tHb (tHb module) - - - - -
SO2 (tHb module) - - - - -
tHb (COOX) 20.4 0.1940 0.95 0.2357 1.15
SO2 (COOX) 97.5 0.1396 0.14 0.1400 0.14
O2Hb 92.5 0.3581 0.39 0.3617 0.39
COHb 3.3 0.1564 4.75 0.1565 4.75
MetHb 1.9 0.0773 4.13 0.0809 4.32
HHb 2.4 0.1244 5.23 0.1249 5.25
Bili 21.6 0.1621 0.75 0.1690 0.78
Table A-12 AUTOTROL PLUS B Level 3, n=40

Material: AUTOTROL PLUS B Level 4B, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 7.418 0.0014 0.02 0.0050 0.07
PCO2 41.3 0.2720 0.66 0.6088 1.48
PO2 96.4 5.0118 5.20 8.9120 9.24
Sodium 140.6 0.3242 0.23 0.5710 0.41
Potassium 4.77 0.0135 0.28 0.0220 0.46
Chloride 101.6 0.3679 0.36 0.9279 0.91
ionized Calcium 1.104 0.0048 0.43 0.0092 0.83
Hct 36.7 0.3883 1.06 0.5049 1.38
Lactate 5.6 0.0304 0.54 0.1607 2.85
Table A-13 AUTOTROL PLUS B Level 4B, n=40

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-65
4 Specifications cobas b 221 system
Performance data

Parameter Mean Swr (CV%) ST (CV %)

Glucose 1.4 0.0204 1.45 0.1026 7.26
Urea 13.1 0.2512 1.91 0.7169 5.46
tHb (tHb module) - - - - -
SO2 (tHb module) - - - - -
tHb (COOX) 6.4 0.0265 0.41 0.1241 1.93
SO2 (COOX) 62.7 0.2002 0.32 0.2514 0.40
O2Hb 36.5 0.1973 0.54 0.2474 0.68
COHb 27.6 0.0869 0.32 0.1091 0.40
MetHb 14.2 0.0414 0.29 0.0518 0.36
HHb 21.7 0.0690 0.32 0.0866 0.40
Bili 4.2 0.0146 0.34 0.0707 1.67
Table A-13 AUTOTROL PLUS B Level 4B, n=40

Material: AUTOTROL PLUS B Level 5B, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 7.412 0.0033 0.04 0.0061 0.08
PCO2 41.4 0.3787 0.91 0.7924 1.91
PO2 94.7 3.1077 3.28 3.2578 3.44
Sodium 139.4 0.7465 0.54 0.8404 0.60
Potassium 4.76 0.0365 0.77 0.0339 0.71
Chloride 102.1 0.7601 0.74 1.3617 1.33
ionized Calcium 1.119 0.0062 0.56 0.0103 0.92
Hct 38.0 1.4404 3.79 1.4027 3.69
Lactate 12.9 0.1628 1.26 0.5348 4.14
Glucose 25.4 0.1913 0.75 0.5098 2.00
Urea 26.4 0.4122 1.56 2.5774 9.75
tHb (tHb module) - - - - -
SO2 (tHb module) - - - - -
tHb (COOX) 23.0 0.2175 0.94 0.3139 1.36
SO2 (COOX) 98.1 0.1568 0.16 0.1744 0.18
O2Hb 94.2 0.4087 0.43 0.4554 0.48
COHb 2.5 0.0852 3.37 0.1053 4.16
MetHb 1.4 0.0397 2.77 0.0519 3.62
HHb 1.8 0.0675 3.83 0.0837 4.75
Bili 24.1 0.2629 1.09 0.2728 1.13
Table A-14 AUTOTROL PLUS B Level 5B, n=40

Roche Diagnostics April 2009

A-66 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Performance data

Material: AUTOTROL TS+ Level 1, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 7.172 0.0037 0.05 0.0054 0.08
PCO2 62.3 0.8276 1.33 1.5073 2.42
PO2 50.6 4.2084 8.32 5.4278 10.74
Sodium 121.9 0.8432 0.69 1.0952 0.90
Potassium 2.98 0.0333 1.12 0.0352 1.18
Chloride 84.8 0.5243 0.62 0.9029 1.06
ionized Calcium 1.591 0.0170 1.07 0.0217 1.36
Hct 56.8 1.5547 2.74 1.5912 2.80
Lactate 9.3 0.0710 0.76 0.4680 5.01
Glucose 5.5 0.0564 1.02 0.1729 3.13
tHb (tHb module) 18.7 0.0256 0.14 0.0440 0.24
SO2 (tHb module) 100.0 0.0112 0.01 0.0112 0.01
Table A-15 AUTOTROL TS+ Level 1, n=40

Material: AUTOTROL TS+ Level 2, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 7.406 0.0022 0.03 0.0043 0.06
PCO2 43.1 0.3800 0.88 0.5716 1.33
PO2 92.5 2.8967 3.13 3.5631 3.85
Sodium 136.9 0.5024 0.37 0.7705 0.56
Potassium 4.70 0.0303 0.64 0.0414 0.88
Chloride 99.4 0.3950 0.40 0.5617 0.56
ionized Calcium 1.146 0.0141 1.23 0.0178 1.56
Hct 41.6 0.3827 0.92 0.7501 1.80
Lactate 1.9 0.0163 0.86 0.0672 3.53
Glucose 2.5 0.0204 0.83 0.1044 4.23
tHb (tHb module) 14.3 0.0773 0.54 0.0794 0.56
SO2 (tHb module) 93.3 0.1776 0.19 0.1855 0.20
Table A-16 AUTOTROL TS+ Level 2, n=40

Material: AUTOTROL TS+ Level 3, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 7.567 0.0023 0.03 0.0047 0.06
PCO2 22.9 0.2652 1.16 0.4763 2.08
PO2 141.8 3.4549 2.44 4.0597 2.86
Sodium 156.3 0.8170 0.52 1.0626 0.68
Potassium 7.03 0.0510 0.72 0.0628 0.89
Chloride 120.3 0.4829 0.40 0.6012 0.50
ionized Calcium 0.599 0.0100 1.67 0.0128 2.13
Table A-17 AUTOTROL TS+ Level 3, n=40

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-67
4 Specifications cobas b 221 system
Performance data

Parameter Mean Swr (CV%) ST (CV %)

Hct 22.9 0.5431 2.37 0.5799 2.53
Lactate 0.8 0.0316 4.02 0.0446 5.68
Glucose 21.3 0.6006 2.82 0.7883 3.70
tHb (tHb module) 8.3 0.0122 0.15 0.0319 0.39
SO2 (tHb module) 93.3 0.0355 0.04 0.0450 0.05
Table A-17 AUTOTROL TS+ Level 3, n=40

Material: AUTOTROL TS+ Level 4A, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 6.880 0.0054 0.08 0.0076 0.11
PCO2 87.5 1.3229 1.51 2.4825 2.84
PO2 22.7 3.6828 16.23 5.1660 22.77
Sodium 88.0 0.5162 0.59 0.8391 0.95
Potassium 8.94 0.0584 0.65 0.1029 1.15
Chloride 67.8 0.5941 0.88 1.3054 1.93
ionized Calcium 2.543 0.0272 1.07 0.0452 1.78
Hct 75.8 0.8202 1.08 1.0158 1.34
Lactate - - - - -
Glucose - - - - -
Urea - - - - -
tHb (tHb module) 11.0 0.0206 0.19 0.0281 0.26
SO2 (tHb module) 88.2 0.0303 0.03 0.0450 0.05
Table A-18 AUTOTROL TS+ Level 4A, n=40

Material: AUTOTROL TS+ Level 5A, n=40

Parameter Mean Swr (CV%) ST (CV %)

pH 7.730 0.0042 0.05 0.0061 0.08
PCO2 9.2 1.3769 15.03 1.4213 15.51
PO2 253.6 6.0686 2.39 8.7795 3.46
Sodium 174.5 0.8890 0.51 1.2891 0.74
Potassium 2.00 0.0250 1.25 0.0346 1.73
Chloride 130.3 0.7821 0.60 1.1922 0.91
ionized Calcium 0.403 0.0065 1.61 0.0109 2.70
Hct 22.0 0.6997 3.18 0.7713 3.50
Lactate - - - - -
Glucose - - - - -
Urea - - - - -
tHb (tHb module) 15.8 0.0196 0.12 0.0316 0.20
SO2 (tHb module) 95.8 0.0469 0.05 0.0596 0.06
Table A-19 AUTOTROL TS+ Level 5A, n=40

Roche Diagnostics April 2009

A-68 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Performance data

Material: MSS Level 1, NIST Traceable, n=80

Parameter Mean Swr (CV%) ST (CV %)

Lactate 9.4 0.0670 0.71 0.2626 2.78
Glucose 5.7 0.0337 0.60 0.1231 2.18
Urea 4.9 0.0391 0.80 0.1837 3.74
Table A-20 MSS Level 1, NIST Traceable, n=80

Material: MSS Level 2, NIST Traceable, n=80

Parameter Mean Swr (CV%) ST (CV %)

Lactate 1.9 0.0188 0.96 0.0497 2.55
Glucose 2.6 0.0267 1.05 0.0972 3.81
Urea 14.5 0.2263 1.56 0.4100 2.83
Table A-21 MSS Level 2, NIST Traceable, n=80

Material: human whole blood incl. bilirubin Level 1, n=40

Parameter Mean Swr (CV%) ST (CV %)

Bili 8.2 0.1202 1.47 0.6198 7.56
Table A-22 Human whole blood incl. bilirubin Level 1, n=40

Material: human whole blood incl. bilirubin Level 2, n=40

Parameter Mean Swr (CV%) ST (CV %)

Bili 24.1 0.1171 0.49 0.9663 4.01
Table A-23 Human whole blood incl. bilirubin Level 2, n=40

Material: human whole blood incl. bilirubin Level 3, n=40

Parameter Mean Swr (CV%) ST (CV %)

Bili 44.0 0.1623 0.37 2.1509 4.89
Table A-24 Human whole blood incl. bilirubin Level 3, n=40

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-69
4 Specifications cobas b 221 system
Performance data

Linearity

Tonometered whole blood Whole blood was tonometered at 37 °C to various level of gravimetrically prepared
gases with CO2 and O2 concentrations certified to ± 0.03% absolute by the
manufacturer. Expected and observed values for PCO2 and PO2 were corrected to
760 mmHg.

Material: tonometered aqueous solution
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 15

Expected value Mean Swr Recovery

Correlation
Slope 0.8311 - 1.2032
Intercept ± 25.3383
Correlation coefficient 0.9997

Parameter: potassium (mmol/L)

Material: NIST 909b
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 15

Expected value Mean Swr Recovery

3.42 3.29 0.0162 96.1
6.28 6.56 0.0273 104.4
Table A-43 Parameter Potassium (mmol/L)

Correlation
Slope 0.8738 - 1.1444
Intercept ± 0.6284
Correlation coefficient 1.0000

Parameter: chloride (mmol/L)

Material: NIST 909b
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 15

Expected value Mean Swr Recovery

89.11 88.59 0.6674 99.4
119.43 115.96 0.9763 97.1
Table A-44 Parameter Chloride (mmol/L)

Correlation
Slope 0.9032 - 1.1072
Intercept ± 8.1053
Correlation coefficient 0.9990

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-79
4 Specifications cobas b 221 system
Performance data

Parameter: glucose (mmol/L)

Material: NIST 909b
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 15

Expected value Mean Swr Recovery

5.40 5.06 0.0294 93.7
15.00 12.17 0.1239 81.1
Table A-45 Parameter Glucose (mmol/L)

Correlation
Slope 0.7429 - 1.3461
Intercept ± 1.0482
Correlation coefficient 0.9997

Parameter: urea (mmol/L)

Material: NIST 909b
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 15

Expected value Mean Swr Recovery

5.51 5.40 0.0248 98.0
Table A-46 Parameter Urea (mmol/L)

Parameter: tHb (g/dL), SO2 (%)

Material: Tonometered whole blood
Number of instruments: 4 cobas b 221<5> systems

Parameter Slope intercept Coefficient Range n

tHb 0.9892 - 1.0109 ± 0.0833 0.9904 6-18 [g/dl] 250
SO2 0.99999 - 1.00001 ± 0.856 0.9874 51.7-100 [%] 382
Table A-47 Parameter tHb (g/dL), SO2 (%)

Roche Diagnostics April 2009

A-80 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Performance data

Parameter: bilirubin (mg/dL)

Material: human whole blood incl. bilirubin
Number of instruments: 2 cobas b 221 systems
Measurements per level and instrument: 3

Expected value Mean Swr Recovery

6.00 6.86 0.0928 114.33
14.00 14.55 0.1417 103.93
28.00 26.28 0.1901 93.86
44.00 41.52 0.0920 94.36
Table A-48 Parameter Bilirubin (mg/dL)

Correlation
Slope 0.9038 - 1.1064
Intercept ± 1.514
Correlation coefficient 0.9996

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-81
4 Specifications cobas b 221 system
Performance data

Correlation to other methods

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 6 Y = -0.063 + 1.009*X +0.007 0.990 134
Radiometer 725 Y = 0.496 + 0.933*X +0.003 0.990 99
(a)
pH meter Y = 0.9963*X 0 0.999 20
Table A-49 pH
(a) pleural fluid - pH measuring instrument, temperature-corrected

PO2
Unit: [mmHg]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 6 Y = -0.643 + 1.031*X +1.6 % 0.987 136
Radiometer 725 Y = 4.433 + 1.013*X +6.6 % 0.996 137
Table A-50 PO2

PCO2
Unit: [mmHg]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
cobas b 121 System Y = -1.452 + 1.038*X +0.4 % 0.988 129
Radiometer 55 Y = -0.301 + 1.000*X -1.2 % 0.992 144
Table A-51 PCO2

tHb (cobas b 221 system with tHb/SO2 module)

Unit: [g/dL]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
Radiometer 725 Y = -0.581 + 1.083*X +2.0 % 0.814 96
Table A-52 tHb

SO2 (cobas b 221 system with tHb/SO2 module)

Unit: [%]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
cobas b 121 System Y = 10.066+ 0.903*X +1.1 % abs. 0.991 130
Radiometer 715 Y = -3.969 + 1.037*X - 0.4 % 0.904 102
Table A-53 SO2

Roche Diagnostics April 2009

A-82 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Performance data

tHb (cobas b 221 system with COOX module)

Unit: [g/dL]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 9 Y = -0.100+ 1.000*X -1.0 % 0.980 135
Radiometer 700 Y = 0.200 + 1.000*X +1.1 % 0.977 125
Table A-54 tHb

O2Hb (cobas b 221 system with COOX module)

Unit: [%]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 6 Y = 2.394+ 0.971*X -0.3 % abs. 0.986 132
Radiometer 725 Y = 14.492 + 0.846*X +0.1 % abs. 0.986 132
Table A-55 O2Hb

HHb (cobas b 221 system with COOX module)

Unit: [%]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 6 Y = -0.069+ 0.987*X -0.1 % abs. 0.986 132
Radiometer 725 Y = 0.316 + 0.816*X -0.5 % abs. 0.980 132
Table A-56 HHb

MetHb (cobas b 221 system with COOX module)

Unit: [%]
For values less than 1.3%:

Comparison instrument Deviation of mean values No. of samples

OMNI 9 -0.3 % abs. 129
Radiometer 725 +0.2 % abs. 131
Table A-57 MetHb

COHb (cobas b 221 system with COOX module)

Unit: [%]
For values less than 3.5%:

Comparison instrument Deviation of mean values No. of samples

OMNI 9 +0.7 % abs. 130
Radiometer 725 +0.1 % abs. 132
Table A-58 COHb

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-83
4 Specifications cobas b 221 system
Performance data

SO2 (cobas b 221 system with COOX module)

Unit: [%]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 6 Y = 0.100+ 1.000*X +0.1 % abs. 0.967 132
Radiometer 725 Y = 17.341 + 0.824*X +0.5 % abs. 0.988 132
Table A-59 SO2

Bilirubin (cobas b 221 system with COOX module)

Unit: [mg/dL]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
Hitachi TBil Y = -0.127+ 0.968*X +3.7 % abs. 0.986 85
Beckman LX 20 tBil Y = -0.537 + 1.060*X +1.4 % abs. 0.980 76
Kodak Vitros tBil Y = -0.119 + 0.988*X -2.4 % abs. 0.984 73
Radiometer Y = -0.327 + 1.044 *X +10.5 % abs. 0.974 82
Table A-60 Bilirubin

Hct
Unit: [%]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 9 Y = -0.182+ 1.003*X -0.4 % abs. 0.918 137
cobas b 121 System Y = -0.689+ 1.040*X +0.6 % abs. 0.946 141
Table A-61 Hct

Sodium
Unit: [mmol/L]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 9 Y = -13.193+ 1.106*X +0.9 % 0.948 108
Radiometer 715 Y = -2.143 + 1.028*X +1.4 % 0.972 107
Table A-62 Sodium

Potassium
Unit: [mmol/L]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 6 Y = -0.126+ 1.020*X -1.4 % 0.986 131
Radiometer 725 Y = -0.323 + 1.083*X +0.6 % 0.989 98
Table A-63 Potassium

Roche Diagnostics April 2009

A-84 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Performance data

Calcium
Unit: [mmol/L]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 9 Y = -0.039+ 1.024*X -0.8 % 0.941 108
cobas b 121 System Y = -0.036+ 1.042*X +1.3 % 0.962 140
Radiometer 725 Y = -0.096 + 1.073*X -1.1 % 0.981 98
Table A-64 Calcium

Chloride
Unit: [mmol/L]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
cobas b 121 System Y = -12.459+ 1.118*X -0.7 % 0.960 139
Radiometer 725 Y = 17.100 + 0.800*X -4.0 % 0.965 98
Table A-65 Chloride

Glucose
Unit: [mmol/L]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 9 Y = -0.461+ 1.034*X -3.9 % 0.938 134
Radiometer 715 Y = -0.867 + 1.201*X +5.2 % 0.986 107
Hitachi (Plasma) Y = -1.207+ 1.127*X -4.9 % 0.990 60
Cobas Mira (Plasma) Y = -0.807 + 1.121*X +0.4 % 0.946 135
Table A-66 Glucose

Urea
Unit: [mmol/L]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 9 Y = 0.343 + 0.850*X -10.8 % 0.957 122
Hitachi (Plasma) Y = 0.053 + 0.882*X -11.1 % 0.990 53
Cobas Mira (Plasma) Y = -0.001 + 0.887*X -11.1 % 0.981 129
Table A-67 Urea

Lactate
Unit: [mmol/L]

Comparison instrument Slope and intercept Bias Corr. coeff. [r] No. of samples
OMNI 9 Y = -0.200+ 1.000*X -9.5 % 0.936 136
Hitachi (Plasma) Y = -0.286+ 1.149*X +0.7 % 0.993 60
Cobas Mira (Plasma) Y = -0.297 + 1.074*X -3.0 % 0.968 137
Table A-68 Lactate

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-85
4 Specifications cobas b 221 system
Sample throughput

Sample throughput

Activated / installed modules Sample throughput [samples/hours]

Syringe Capillary
BG - tHb/SO2 31 29
BG - COOX 31 29
BG - ISE - tHb/SO2 31 28
BG - ISE - COOX 31 29
BG - ISE - MSS - tHb/SO2 31 28
BG - ISE - MSS (Glu/Lac) - COOX 30 27
BG - ISE - MSS (Glu/Lac/Urea) - COOX 30 27
Table A-69 Sample throughput

Measurement times of the samples

Activated / installed modules Measurement times [seconds]

Total time Until display
BG - tHb/SO2 110 66
BG - COOX 110 76
BG - ISE - tHb/SO2 115 66
BG - ISE - COOX 110 76
BG - ISE - MSS (Glu, Lac) - tHb/SO2 115 88
BG - ISE - MSS (Glu, Lac) - COOX 120 88
BG - ISE - MSS (Glu, Lac, Urea) - COOX 120 120
Table A-70 Measurement times of the samples

Roche Diagnostics April 2009

A-86 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Sample volumes

Sample volumes

The minimum sample volume requirement is dependent on Hct concentration in the sample!

Activated / installed modules Typical sample volume Typical sample volume Max. sample volume
[µL](a) [µL](b) (volume limitation by the
sample sensor) [µL](c)
BG - tHb/SO2 or COOX 88 102 111
BG - ISE - tHb/SO2 or COOX 112 128 148
BG - ISE - MSS - tHb/SO2 or COOX 172 186 210
Table A-71 Sample volumes
(a) typical sample volume for Hct ≤ 45%
(b) typical sample volume for 45% < Hct ≤ 75%: if a sample with high Hct is expected, the sample volume for high Hct is recommended.
(c) The sample volume limitation is the maximum volume of sample which is aspirated from the container.

The volume limitation by the sample sensor depends on INSTALLED modules, regardless whether
they are activated or deactivated!
The actual required sample volume depends on the used sample container.

Activated / installed modules Sample container Minimum level

BG - ISE - MSS - tHb/SO2 or COOX 1 mL syringe 300 μL
3 mL syringe 700 μL
5 mL syringe 1 mL
200 μL capillary 186 μL
Table A-72 Sample container

Sample types

o Whole blood
o Serum
o Plasma(a)
o Dialysis solutions containing acetate and bicarbonate(b)
o Recommended QC material(c)

(a) also used for pH measurements in the pleural fluid

(b) only for electrolytes
(c) with approximate physiological ion matrix and buffer capacity

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-87
4 Specifications cobas b 221 system
Calibrations

Calibrations

Calibrations Time intervals Duration without MSS Duration with MSS

[min] [min]
System calibration every 24 hours 11 Glu/Lac: 15.5
(alternatively 8, 12 or 24 hours) Glu/Lac/Urea: 17
1P calibrations every 30 minutes 1.6 3.3
(alternatively 1 hour)
2P calibrations every 12 hours 6.2 11.4
(alternatively 4, 8 or 12 hours)
Warm-up phase when turning ON(a) 32 43
Warm-up phase power failure < 1 minute 2.5 2.5
Electrode exchange as needed 25 50
Table A-73 Calibrations
(a) incl. calibration

Roche Diagnostics April 2009

A-88 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Environmental parameters

Environmental parameters

Temperature / humidity / stability

Instrument

Operating conditions
o Ambient temperature 15 to 31 °C
o Ambient air pressure 526 - 797 mmHg (70.13 - 106.225 kPa)
o Relative humidity 20 - 85%
o Measuring chamber
temperature
BG & ISE 37 ± 0.2 °C
MSS 30 ± 0.2 °C
COOX 37 ± 0.5 °C
tHb/SO2 37 °C (35 to 37.5 °C)

Storage and transportation conditions

o Temperature -20 to 50 °C
o Humidity 20 to 85% (not condensed)
o Shock resistance < 30 g

Electrodes

Operating conditions
o Temperature
BG, ISE 37 ± 0.2 °C
MSS (Glu, Lac, Urea/BUN) 30 ± 0.2 °C
o Relative humidity 20 to 85%

Storage conditions in original packaging

o Temperature
BG, ISE 15 to 30 °C
MSS (Glu, Lac, Urea/BUN) 2 to 8 °C
o Relative humidity 20 to 85% (not condensed)

Transportation conditions in original packaging

o Temperature
BG, ISE -5 to 40 °C over a period of 3 days
MSS (Glu, Lac, Urea/BUN) -5 to 35 °C over a period of 5days
o Humidity 20 to 85 % (not condensed) over a period of 3 days
o Shock resistance < 30 g

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-89
4 Specifications cobas b 221 system
Environmental parameters

Solutions

Operating conditions
o Ambient temperature 15 to 35 °C
o Relative humidity 20 to 85%

Storage conditions in original packaging

o Temperature
S1 rinse Solution 2 to 30 °C (24 months(a))
S2 fluid Pack 2 to 30 °C (18 months(a))
S3 fluid Pack 2 to 25 °C (18 months(a))
o Relative humidity 20 to 85%
(a) storage time contains also transportation time and the storage time in Mannheim!

Transportation conditions in original packaging

o Temperature 2 to 35 °C over a period of 7 days
o Relative humidity 20 - 85%
o Shock resistance < 30 g

Stability during operation

Solutions Description with 15 - 31 °C ambient
temperature [weeks]
o S1 Rinse Solution Wash solution 6
o S2 Fluid Pack Calibration solution BG, ISE 6
o S3 Fluid Pack Calibration solution Glu, Lac, Urea/BUN 6

QC material

Storage conditions in original packaging

cobas b 221<1>/<3>/<5> system
o COMBITROL TS+ up to 24 months at 2 to 8 °C
o AUTO-TROL TS+ up to 24 months at 2 to 8 °C
cobas b 221<2>/<4>/<6> system
o COMBITROL PLUS B up to 24 months at 2 to 8 °C
o AUTO-TROL PLUS B up to 24 months at 2 to 8 °C

Stability during operation

cobas b 221<1>/<3>/<5> system
o COMBITROL TS+ Up to 3 months at room temperature up to 28 °C
o AUTO-TROL TS+ Up to 3 months at room temperature up to 28 °C
(incl. max. 1 month in the AutoQC module)
cobas b 221<2>/<4>/<6> system
o COMBITROL PLUS B Up to 3 months at room temperature up to 28 °C
o AUTO-TROL PLUS B Up to 3 months at room temperature up to 28 °C
(incl. up to 60 days in the AutoQC module)

Roche Diagnostics April 2009

A-90 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Product data

Product data

Electrical data

Mains voltage range: 100 to 240 VAC ±10% permissible tolerance

Frequency: 50/60 Hz
Required power: 200 W

Classification

Protection class: I
Overvoltage category: II
Contamination level: 2

Dimensions

Width: 51 cm
Height: 59 cm
Depth: 60 cm

Weight

cobas b 221 system (instrument): approx. 45 kg (without wash/calibrating solutions

and AutoQC!)

Acoustic noise level

In all operating conditions: min. 37.0 dB

max. 51.8 dB

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-91
4 Specifications cobas b 221 system
AutoQC

Holding points

Take care when lifting - weight of the instrument without wash/calibrating solutions and AutoQC
is approx. 45 kg!

Figure A-54 Holding points

AutoQC

Number of ampoules: 6 mats each with 20 ampoules

Printer

Type: Thermal printer with integrated paper cutter and

optional take-up unit
Resolution: 8 dots / mm
Full graphics: 864 dots / line
Printing speed: max. 20 mm / sec
Paper width: 111 mm
Paper length: about 50 m

Roche Diagnostics April 2009

A-92 Instructions for Use · Revision 10.0
cobas b 221 system 4 Specifications
Touch screen-PC unit

Touch screen-PC unit

SN < 1500

PC: AMD 5x86 Single Board PC, 133 MHz

Memory: 32 MB RAM
Hard disk: 2 GB Harddisk
Floppy disk drive: 1.44 MB; integrated at the right side of the screen
Screen - type: TFT-LCD-screen
Format: 10.4 inch
Resolution: 640 x 480 pixel

SN > 1500

PC: GEODE GXII, 200 MHz

Memory: 128 MB RAM
Hard disk: 20 GB Harddisk
Floppy disk drive: 1.44 MB; integrated at the right side of the screen
Screen - type: TFT-LCD-screen
Format: 10.4 inch
Resolution: 640 x 480 pixel

SN > 5000

PC: GEODE GXII, 200 MHz

Memory: 128 MB RAM
Hard disk: 40 GB Harddisk
Floppy disk drive: 1.44 MB; integrated at the right side of the screen
Screen - type: TFT-LCD-screen
Format: 10.4 inch
Resolution: 640 x 480 pixel

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-93
4 Specifications cobas b 221 system
Barcode scanner

Barcode scanner

Type: MT 9060/4 Wedge PS2 hand scanner with integrated

decoder
Reading speed: up to 45 scans/s
Resolution: 0.1 mm
Reading distance: up to 5 cm
Reading width: up to 8 cm
(a): o
Preprogrammed code types China Postal Code
o Codabar
o Code 39
o Code 128
o EAN-8
o EAN-13
o EAN-128
o Interleaved 2 of 5
o UPC-A
o UPC-E
(a) Further available barcode types can be programmed in accordance with the enclosed manual of the
PS2 hand-held scanner (included in scope of delivery).

Roche Diagnostics April 2009

A-94 Instructions for Use · Revision 10.0
cobas b 221 system 5 Theoretical foundations
Contents

Theoretical foundations

This chapter contains the formulae for calculation values, factors and unit conversion,
as well as the clinical significance of measurement parameters.

In this chapter Chapter 5

Parameters and calculations ......................................................................................... 97
Conversion table for units ....................................................................................... 97
Temperature ....................................................................................................... 97
Standard values and ranges ..................................................................................... 97
Equations ................................................................................................................. 98
H+ ....................................................................................................................... 98
cHCO3- ............................................................................................................... 98
ctCO2(P) ............................................................................................................ 98
FO2Hb ................................................................................................................ 98
BE ....................................................................................................................... 99
BEecf .................................................................................................................... 99
BB ....................................................................................................................... 99
SO2 ...................................................................................................................... 99
SO2(c) ............................................................................................................... 99
P50 ..................................................................................................................... 100
ctO2 .................................................................................................................. 101
ctCO2(B) .......................................................................................................... 101
pHst ................................................................................................................... 101
cHCO3-st .......................................................................................................... 102
PAO2 ................................................................................................................. 102
AaDO2 .............................................................................................................. 102
a/AO2 ................................................................................................................ 102
avDO2 ............................................................................................................... 102
RI ...................................................................................................................... 103
Shunt ................................................................................................................ 103
nCa2+ ................................................................................................................ 104

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Instructions for Use · Revision 10.0 A-95
5 Theoretical foundations cobas b 221 system
Contents

AG ..................................................................................................................... 104
pHt .................................................................................................................... 105
H+t .................................................................................................................... 105
PCO2t ............................................................................................................... 105
PO2t .................................................................................................................. 105
PAO2t ................................................................................................................ 105
AaDO2t ............................................................................................................. 105
a/AO2t ............................................................................................................... 106
RIt ..................................................................................................................... 106
Hct(c) ............................................................................................................... 106
MCHC .............................................................................................................. 106
BO2 ................................................................................................................... 106
BEact .................................................................................................................. 107
Osmolality ........................................................................................................ 107
OER .................................................................................................................. 107
Heart minute volume (Qt) .............................................................................. 108
P/F Index .......................................................................................................... 108
Bibliography .......................................................................................................... 108
Clinical significance .................................................................................................... 109
pH ........................................................................................................................... 109
PCO2 ...................................................................................................................... 110
PO2 ......................................................................................................................... 110
Sodium ................................................................................................................... 111
Potassium ............................................................................................................... 112
Chloride ................................................................................................................. 114
Ionized calcium ..................................................................................................... 115
Hematocrit ............................................................................................................. 117
tHb (total hemoglobin concentration) ................................................................ 118
Oxygen saturation ................................................................................................. 119
Hemoglobin derivatives and bilirubin ................................................................. 120
Oxyhemoglobin (O2Hb) ................................................................................. 121
Desoxyhemoglobin (HHb) ............................................................................. 121
Carboxyhemoglobin (COHb) ........................................................................ 121
Methemoglobin (MetHb) ............................................................................... 122
Total bilirubin (= neonatal) ............................................................................ 123
Glucose ................................................................................................................... 124
Lactate .................................................................................................................... 125
Urea/BUN .............................................................................................................. 126

Roche Diagnostics April 2009

A-96 Instructions for Use · Revision 10.0
cobas b 221 system 5 Theoretical foundations
Parameters and calculations

Parameters and calculations

Conversion table for units

The cobas b 221 system provides an array of useful parameters, which are calculated
from the measurement values of each sample. Refer to the following table for an
explanation of the symbols used in the equations. Unless otherwise noted, all
measured values used in the equations are no longer valid at 37 °C.

ctO2, avDO2, ctCO2 1 vol% = 1 mL/dL = 0.4464 mmol/L

2+
Ca 1 mmol/L = 4.008 mg/dL
tHb 1 g/dL = 10 g/L = 0.6202 mmol/L
Glucose 1 mmol/L = 18.02 mg/dL
Lactate 1 mmol/L = 9.008 mg/dL
BUN 1 mmol/L = 1.4007 mg/dL
Urea 1 mmol/L = 6.0056 mg/dL
Urea/BUN 1 mmol/L Urea = 2 mmol/L BUN = 2.8014 mg/dL BUN
Bilirubin 1 mg/dL = 17.1 μmol/L
Osmolality 1 mOsm/kg = 1 mmol/kg
MCHC 1 g Hb/dL Ery = 0.155 mmol Hb/L Ery
Air pressure, PCO2, PO2 1 mmHg = 1.3333 mbar = 0.1333 kPa
1 mmHg = 39.37x10-3 Inch [in.]Hg
Table A-74 Conversion table for units

Temperature
9
Equation A-1 T [ °F ] = --- × T [ °C ] + 32
5
5
Equation A-2 T [ °C ] = --- × ( T [ °F ] – 32 )
9

Standard values and ranges

Parameter Standard value Possible range

tHb 15.0 g/dL 1.0 ... 26.0 g/dL
150 g/L 1 ... 260 g/L
9.0 mmol/L 1.0 ... 16.0 mmol/L
FIO2 0.21 0.10 ... 1.00
R (Respiratory quotient) 0.84 0.70 ... 2.00
Patient's temperature 37.0 °C 2.0 ... 44.0 °C
98.6 F 35.6 ... 111.0 F
Hb factor 3.0 2.7 - 3.3
Table A-75 Standard values and ranges

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-97
5 Theoretical foundations cobas b 221 system
Parameters and calculations

Equations(a)

All literature data stated in this section (e.g. [1]) are stated afterwards in the section "Bibliography".

The validity of calculated results from the cobas b 221 system must be carefully
examined by a clinical-medical specialist who will take the patient's clinical condition
into consideration before any clinical decisions are reached based on the calculated
results especially if one of the according measurement results exceeds its critical
range.

Calculated values that require measurement results from arterial blood are issued only for the set
blood types "arterial" and "capillary"!

H+
Hydrogen ion concentration[1]
Unit: [nmol/L]

Equation A-3 H+ = 10(9-pH)

cHCO3-
Bicarbonate concentration in plasma.[1]
Unit: [mmol/L]

Equation A-4 cHCO3- = 0.0307 * PCO2 * 10(pH-6.105)

ctCO2(P)
Total concentration of CO2 in plasma, the sum of dissolved CO2 and bicarbonate.[1]
Unit: [mmol/L]

Equation A-5 ctCO2(P) = cHCO3- + (0.0307 * PCO2)

FO2Hb
Fractional oxygen saturation[1]
Unit: [-]

O 2 Hb
Equation A-6 FO 2 Hb = --------------
-
100

(a) all not listed equations are not realized!

Roche Diagnostics April 2009

A-98 Instructions for Use · Revision 10.0
cobas b 221 system 5 Theoretical foundations
Parameters and calculations

BE
The base deviation of the blood results from a calculation to determine the titratable
base of the blood, which in principle is measured by titration of the blood with a
strong acid or base to a pH of 7.4 with PCO2 = 40 mmHg at 37 °C.[1]
Unit: [mmol/L]

BE = (1 − 0.014 ⋅ tHb) ⋅ [(1.43⋅tHb + 7.7 ) ⋅ (pH − 7.4 ) − 24.8 + cHCO 3 ]

−
Equation A-7

e For BEact see Equation A-40 on page A-107 !

BEecf
The base deviation of extracellular fluid is a quantity that reflects only the non-
respiratory components of acid-base balance.[1]
Unit: [mmol/L]

BE ecf = 16.2⋅(pH − 7.4 ) − 24.8 + cHCO 3

−
Equation A-8

BB
The buffer base is the concentration of buffering anions which is available in whole
blood to buffer strong acids and consists mainly of protein anions and bicarbonate.
Of the protein anions, hemoglobin is the most significant.[2]
Unit: [mmol/L]

Equation A-9 BB = BE + 41.7 + 0.42 ⋅ tHb

SO2
The quantity of oxyhemoglobin in the blood related to the quantity of hemoglobin in
the blood which can bind oxygen.[1]
Unit: [%]
O 2 Hb
COOX module: Equation A-10 SO 2 = ⋅100
O 2 Hb + HHb

tHb/SO2 module SO2 is measured

SO2(c)
No SO2 data available:

Measured SO2 has a higher priority than the calculated SO2(c).

No calculation without pH, PO2 or BE.

Unit: [%]

Q
Equation A-11 SO 2 (c ) = SO ( P O 2 , pH, P 50, a/f, BE) = ⋅ 100
Q +1

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-99
5 Theoretical foundations cobas b 221 system
Parameters and calculations

At which:
k
lgQ = 2.9 ⋅ lgPO 2 + F1 ⋅10 − F 2⋅PO 2 − F3
k

Equation A-12 P 50
lgPO k2 = lgPO 2 + 0.48 ⋅ (pH - 7.4) - lg( ) + 0.0013 ⋅ BE
26.7

Adult P50 = 26.7

F1 = 1.661
F2 = 0.074
F3 = 4.172

Fetal P50 = 21.5

F1 = 1.3632
F2 = 0.0533
F3 = 4.113

P50
The oxygen partial pressure at half saturation, P50, is defined as the PO2 value at
which 50% of the hemoglobin is saturated with oxygen. The actual P50 value can be
calculated from interpolation after measurement of the actual oxygen saturation if a
blood sample is tonometered with oxygen so that an oxyhemoglobin of 50% is
achieved (pH value = 7.4 and PCO2 = 40 mmHg).[3]
The cobas b 221 system enables the derivation of the P50 from SO2%, PO2 and pH.
Unit: [mmHg]
Measured SO2 values available:

P 50 = 26.7⋅10 (lgPO 2 −lgPO 2 )

k
Equation A-13

At which:

(lg Q + F3)
k
lg PO 2 =
2 .9
Equation A-14
SO 2
Q=
100% − SO 2

Adult F3 = 4.172

Fetal F3 = 4.113

If no measured SO2 values are available, no calculation is possible.

Roche Diagnostics April 2009

A-100 Instructions for Use · Revision 10.0
cobas b 221 system 5 Theoretical foundations
Parameters and calculations

ctO2
Oxygen content is the sum of oxygen bound to hemoglobin as O2Hb and the amount
of oxygen dissolved in the plasma.[1]
Unit: [vol%]

X
Equation A-15 ctO 2 ( PO 2 , SO 2 , tHb) = 1.39 ⋅ ⋅ tHb + 0.00314 ⋅ PO 2
100
At which:
cobas b 221 system with COOX module: X = O2Hb
cobas b 221 system with tHb/SO2 Module: X = SO2
Only BG values available: X = SO2(c)
e see equation SO2 on page A-99 !

If PO2 is not available, ctO2 is calculated with PO2 = 90 mmHg.

ctCO2(B)
Total concentration of CO2 in the blood, the sum of the total CO2 in plasma and the
red blood cell (erythrocyte fluid = ERY).
Unit: [mmol/L]

ctCO 2 (B) =
Equation A-16 tHb
0.000768 ⋅ PCO 2 ⋅ tHb ⋅ (1 + 10(pH ERY − pK ERY ) ) + ctCO 2 (P) ⋅ (1 − )
33.8
At which:

SO 2
pH ERY = 7.19 + 0.77 ⋅ (pH − 7.4) + 0.035 ⋅ (1 − )
Equation A-17
100
so 2
(pH ERY − 7.84 − 0.06⋅ )
pK ERY = 6.125 − lg(1 + 10 100
)
SO2 or if SO2 not available, SO2(c) Equation A-11 on page A-99.

A correct calculation of the calculated value is possible only after measurement of a whole blood
sample in the sample type setting "blood".

pHst
Standard pH value of the blood is defined as the pH value of a blood sample which
has been equilibrated at 37 ºC with a gas mixture having a PCO2 = 40 mmHg.
Unit: [pH unit]

Equation A-18 pH st = (0.8262 − 0.01296 ⋅ tHb + 0.006942 ⋅ BE) ⋅ lg(0.025 ⋅ PCO 2 ) + pH

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-101
5 Theoretical foundations cobas b 221 system
Parameters and calculations

cHCO3-st
Standard bicarbonate of the blood, defined as the plasma bicarbonate concentration
in blood which has been equilibrated at 37 °C with a gas mixture having a
PCO2 = 40 mmHg.
Unit: [mmol/L]

= 10 (pH st − 6.022 )
−
Equation A-19 cHCO3 st

PAO2
The alveolar oxygen partial pressure is used to calculate several parameters used for
oxidation and breathing.[1]
Unit: [mmHg]

⎡ 1 − FIO 2 ⎤
PAO 2 = ( Ptotal − 47)⋅FIO2 − PACO 2 ⋅⎢ FIO2 +
R ⎥⎦
Equation A-20
⎣
PACO2 = PaCO2 (alveolar PCO2)
for PAO2 ≥ PO2; otherwise PAO2 = PO2
e For t unequal 37°C see Equation PAO2t on page A-105 !

AaDO2
The alveolar arterial oxygen partial pressure gradient (PAO2 - PaO2) is the difference
between the alveolar oxygen partial pressure, as calculated above, and the measured
oxygen partial pressure of arterial blood. [1]
Unit: [mmHg]
Equation A-21 AaDO2 = PA O2 - Pa O2
e For t unequal 37°C see equation AaDO2t on page A-105 !

a/AO2
Arterial alveolar oxygen partial pressure ratio.[1]
Unit: [%]

PaO 2
Equation A-22 a/AO 2 = ⋅100
PAO2
e For t unequal 37°C see equation a/AO2t on page A-106 !

avDO2
The arterial venous oxygen tension ratio.[4]
Unit: [vol%]
Formula - data from venous blood available:
Equation A-23 avDO 2 = ctO 2 ( a ) – ctO 2 ( v )

Roche Diagnostics April 2009

A-102 Instructions for Use · Revision 10.0
cobas b 221 system 5 Theoretical foundations
Parameters and calculations

Calculated ctO2(a) and ctO2(v) according to the calculation for ctO2 for arterial and
venous blood.
e for ctO2 see Equation A-14 on page A-101 !

Calculation only under the following conditions:

o same patient numbers for both measurements
o two consecutive measurements
o sample type is arterial and mixed venous blood

RI
The respiratory index is calculated as the ratio of the alveolar-arterial oxygen tension
gradient to the arterial oxygen tension.[1]
Unit: [%]

( PAO2 − PaO 2 )
Equation A-24 RI = ⋅ 100
PaO 2
e For t unequal 37°C see Equation A-34 on page A-106 !

Shunt
The shunt parameter is a measure of the direct mixing of venous blood into the
oxygenated blood circulation. The Shunt parameter gives the short circuit volume
relating to the total volume (% - value).[1]
In order to determine the "shunt" (Qs/Qt), two independent measurements are
necessary.
Both measurements must be carried out with the same patient ID. The patient ID
must therefore be defined as an input value.
1 Measurement with blood type "mixed venous"
2 Measurement with blood type "arterial":
Select blood type "arterial". The desired value for Qs/Qt is determined.
The same patient ID must be used as for the first measurement!

With a combination of arterial and venous blood, the Qs/Qt value cannot be determined.
Samples from patients with other patient ID can be measured between the two Qs/Qt partial
measurements.
The period between the two Qs/Qt partial measurements is not limited by the instrument.

Additional information The internal calculation procedure requires the following measurement and
calculation values:
o tHb, SO2 (arterial)
o PO2 (arterial)
o PAO2
o ctO2(arterial)
In order to obtain these measurement and calculation values, the blood type "arterial"
must be selected.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 A-103
5 Theoretical foundations cobas b 221 system
Parameters and calculations

Furthermore, the internal calculation procedure requires the following calculation

value:
o ctO2(mixed venous)
To produce this computing value, the blood type "mixed venous" must be selected.
In order to be able to select the blood type, it must be defined as an input value.
h Setup > Display & Reports> Measurement > Input value

Unit: [%]

SaO 2
100 ⋅ [1.39 ⋅ tHb ⋅ (1 − ) + (PAO 2 − PaO 2 ) ⋅ 0.00314]
Qs 100
Equation A-25 =
Qt SaO 2
[(ctO 2 (a) − ctO 2 (v)) + 1.39 ⋅ tHb ⋅ (1 − ) + (PAO 2 − PaO 2 ) ⋅ 0.00314]
100

Qs shunt flow
Qt heart minute volume
Qs/Qt fraction of cardiac output shunted
SaO2 arterial oxygen saturation fraction

ctO2(a) and ctO2(v) are calculated according to Equation A-14 for arterial and mixed
venous blood:
e for ctO2 see Equation A-14 on page A-101 !

If no measurement data is available for mixed venous blood, then the following is
valid:
Equation A-26 ctO2(a)-ctO2(v) = 5.15 vol%

nCa2+
The ionized calcium value standarized to pH = 7.40.[5]
Unit: [mmol/L]

Equation A-27 nCa 2+ ( pH = 7.4) = Ca 2+ ⋅ 10 F5⋅(pH−7.4)

Blood: F5 = 0.22
Serum/plasma: F5 = 0.24
This equation is released for pH 7.2 to 7.6.

AG
The anion gap is a calculated parameter used to express the difference in
concentrations of major cations and anions in the blood sample.[2]
Unit: [mmol/L]
−
Equation A-28 AG = Na + + K + - Cl - - cHCO 3

Roche Diagnostics April 2009

A-104 Instructions for Use · Revision 10.0
cobas b 221 system 5 Theoretical foundations
Parameters and calculations

pHt
pH corrected to patient temperature other than 37 °C.[1]
Unit: [pH-Unit]

Equation A-29 pHt = pH − [0.0147 + 0.0065 ⋅ (pH − 7.4)] ⋅ (t − 37)

H+t
Hydrogen ion concentration at a patient temperature other than 37 °C.[1]
Unit: [nmol/L]
t
Equation A-30 H + t = 10 (9− pH )

PCO2t
PCO2 value at a patient temperature which is not 37 °C.[3]
Unit: [mmHg]

Equation A-31 PCO 2 t = PCO 2 ⋅ 100.019⋅( t−37)

PO2t
PO2 value at a patient temperature which is not 37 °C.[3]
Unit: [mmHg]

⎡ 5.49⋅10 −11⋅PO 2 3.88 + 0.071⎤

Equation A-32 ⎢ −9 3.88 ⎥ ⋅( t − 37 )
⎣⎢ 9.72⋅10 ⋅PO 2 + 2.30 ⎦⎥
PO 2 = PO 2 ⋅ 10
t

PAO2t
Alveolar oxygen partial pressure at a patient temperature other than 37 °C.[1]
Unit: [mmHg]

t ⎡ ⎛ 1 − FIO 2 ⎞⎤
Equation A-33
t
( )
PAO 2 = Ptotal − PH 2 O t ⋅ FIO 2 − PACO 2 ⋅ ⎢ FIO 2 + ⎜ ⎟⎥
⎣ ⎝ R ⎠⎦

for: PAO 2t ≤ PO 2t otherwise PAO 2 t = PO 2t

[ 0.0237 − 0.0001 ⋅ ( t − 37 )]⋅ ( t − 37 )

with: PH 2 O t = 47 ⋅10

AaDO2t
Alveolar oxygen partial pressure at a patient temperature other than 37 °C.[1]
Unit: [mmHg]

Equation A-34 AaDO 2 t = PAO 2 t − PaO 2 t

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Parameters and calculations

a/AO2t
Arterial alveolar oxygen partial pressure ratio at the patient’s temperature.[1]
Unit: [%]
t
t PaO 2
Equation A-35 a/AO2 = t
⋅100
PAO 2

RIt
Respiratory index corrected to patient temperature other than 37 °C.[1]
Unit: [%]
t t
( PAO 2 − PaO 2 )
Equation A-36 RI t = t
⋅100
PaO 2

Hct(c)
Hct as a function of tHb.[4]

F
Equation A-37 Hct(c) = tHb ⋅
100

Default value of F = 3.00 (input range: 2.70 to 3.30).

Only measured tHb is permitted!

MCHC
Mean corpuscular hemoglobin concentration.[4]
Units: [g (Hb) / dL (Ery)]

tHb
Equation A-38 MCHC = ⋅ 100
Hct
Only displayed as a calculated value if both values are measured.

BO2
Oxygen capacity.[1]
Unit: [vol%]

⎡ (COHb − MetHb − SulfHb ) ⎤

Equation A-39 BO 2 = tHb ⋅ ⎢1 − ⎥ ⋅1.39
⎣ 100 ⎦
SulfHb = 0, if SulfHb is not measured!

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Parameters and calculations

BEact
Base deviation at actual oxygen saturation.[2]
Unit: [mmol/L]

BEact = (1 - 0.0143⋅ tHb) ⋅ [(1.63 ⋅ tHb + 9.5) ⋅ (pH − 7.4) − 24.26 + cHCO3− ] −
Equation A-40 ⎛ SO ⎞
− 0.2 ⋅ tHb⋅ ⎜1− 2 ⎟
⎝ 100 ⎠

Osmolality
Unit: [mOsm/kg][3]
Equation for blood, plasma, serum:

Equation A-41
Osm = 1.86 ⋅ Na + + Glu + Urea + 9

Equation for aqueous solution, acetate, bicarbonate:

Equation A-42 Osm = 2 ⋅ (Na + + K + ) + 3 ⋅ (Ca 2+ + Mg 2+ ) + Glu + Urea

Default values:

o K+ = 4.3 mmol/L
o Ca2+ = 1.25 mmol/L
o Mg2+ = 0.6 mmol/L
o Glu = 4.5 mmol/L
o Urea = 5 mmol/L

Explanation:

Na+: if no measurement value is available, no osmolality is calculated

K+: if no measurement value is available, the default value is used for the calculation
Ca2+: if no measurement value is available, the default value is used for the calculation
Mg2+: the default value is used for the calculation
Urea: if no measurement value is available, the default value is used for the calculation
Glu: if no measurement value is available, the default value is used for the calculation

OER
Oxygen extraction ratio.
Unit: [%]

(ctO 2(a) − ctO 2(v) )

Equation A-43 OER = ⋅ 100
ctO 2(a)
e for ctO2 see Equation A-14 on page A-101 !

Different calculation, depending on whether COOX values are available or not!

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Parameters and calculations

Heart minute volume (Qt)

Unit: [vol%][1]

Q t = ctO2 (A) − ctO2 (v)

Equation A-44 SaO 2
= [(ctO 2 (a) − ctO 2 (v)) + 1.39 ⋅ tHb ⋅ (1 − ) + (PAO2 − PaO 2 ) ⋅ 0.00314]
100

SaO2: arterial oxygen saturation fraction

P/F Index
Ration PaO2/FIO2 [1]
Unit: [mm/Hg]

PaO 2
Equation A-45 P/F Index =
FIO 2

Bibliography

1 Clinical and Laboratory Standards Institute. Blood gas an pH related

measurements, CLSI document C46-A; Approved Guideline (2001).
2 Müller-Plathe, Oswald: Säure-Basen-Haushalt und Blutgase/ Breuer, Büttner,
Stamm. Stuttgart; New York: Georg Thieme Verlag, 1982.
3 Burtis, Carl A.; Ashwood, Edward R.: Tietz Textbook of Clinical Chemistry.
4rd Edition. W.B. Saunders Company, 2006.
4 Thomas Lothar: Labor und Diagnose: Indikation und Bewertung von
Laborbefunden für die medizinische Diagnostik; 5. Auflage. Frankfurt am Main:
TH- Books- Verl.- Ges., 2000
5 Thode, J.; Fogh- Andersen, N.; Wimberley, P.D.; Moller Sorensen, A.; Siggaard-
Andersen, O.: Relation between pH and ionized calcium in vitro and in vivo man.
Scand. J. clin. Invest, 43, Suppl.165, 79-82, 1983

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Clinical significance

Clinical significance

The pH value of blood, serum or plasma may be the single most valuable factor in the
evaluation of the acid-base status of a patient. The pH value is an indicator of the
balance between the buffer (blood), renal (kidney) and respiratory (lung) systems,
and one of the most tightly controlled parameters in the body. The causes of
abnormal blood pH values are generally classified as:

pH < 7.35 o primary bicarbonate deficit – metabolic acidosis

o primary hypoventilation – respiratory acidosis

pH > 7.45 o primary bicarbonate excess – metabolic alkalosis

o primary hyperventilation – respiratory alkalosis
An increase in blood, serum or plasma pH (alkalosis) may be due to increased plasma
bicarbonate, or a feature of respiratory alkalosis because of an increased elimination
of CO2 due to hyperventilation.
A decrease of the pH value (acidosis) in blood, serum or plasma may occur due to an
increased formation of organic acids, a decreased excretion of H+ ions in certain renal
disorders, an increased acid intake such as in salicylate poisoning or loss of alkaline
body fluids. Respiratory acidosis is the result of decreased alveolar ventilation and
may be acute, as the result of pulmonary edema, airway obstruction or medication, or
maybe be chronic, as the result of obstructive or restrictive respiratory diseases.

Standard values:
o Arterial blood: 7.35 - 7.45
o Venous blood: 7.31 - 7.41

Critical values(a):
o pH < 7.2
o pH > 7.6
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

The pH measurement of pleural fluid can be a clinically useful tool in the

management of patients with parapneumonic effusions.

Critical values:
o pH > 7.3 uncomplicated parapneumonic effusions
o pH < 7.6 complicated parapneumonic effusions, exudative in nature.
These exudates are caused by pleural empyemas, malignant
tumors, collagenoses, tuberculosis, esophageal rupture, or
hemothorax.

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Clinical significance

PCO2

The PCO2 value of arterial blood is used to assess how well the body eliminates
carbon dioxide in relation to the metabolic rate of CO2 production. An arterial PCO2
below the normal range is termed respiratory alkalosis and indicates hypocapnia, a
condition caused by increased alveolar ventilation such as hyperventilation.
An arterial PCO2 above the normal range is termed respiratory acidosis and indicates
hypercapnia, a sign of hypoventilation and failure, resulting from cardiac arrest,
chronic obstructive lung disease, drug overdose, or chronic metabolic acid-base
disturbances.

Standard values:
o Arterial blood: 35 - 45 mmHg
o Venous blood: 41 - 51 mmHg

Critical values(a):
o PCO2 < 20 mmHg or 2.7 kPa
o PCO2 > 70 mmHg or 9.3 kPa
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

PO2

The PO2 value in arterial blood is one of the main factors in calculating arterial
oxygenation. Values below the normal range (arterial hypoxia) are normally caused
by blockages in the lung and respiratory tract as well as in the blood circulatory
system (for example: bronchial obstruction, vascular disturbances, lessened cardiac
function, increased need for oxygen, anatomical cardiac defect, lower level of inspired
O2). In general, PO2 values over 100 mmHg do not contribute significantly to the
oxygen level because with a normal hemoglobin concentration of 80-100 mmHg PO2,
a saturation level of 97% has already been achieved.

Standard values:
o Arterial blood: > 80 mmHg
o Venous blood: 30 - 40 mmHg

Critical values(a):
o PO2 < 40 mmHg or 5.3 kPa
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

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Clinical significance

Sodium

The fast majority of sodium in organisms is located in the extracellular area (about
97 %).
Even with greatly varying supply with nourishment, the sodium concentration in
serum is subject to strong regulation. In the kidneys, sodium is glomerularly filtered
and most of this (about 60 - 70 %) is reabsorbed in the proximal tubule.
The most important function of the sodium is to maintain constant osmolarity in the
extracellular fluid. For that reason, the level of sodium and water are always closely
interrelated. However, in pathological operations, there may be marked tissue hypo or
hyperhydration with values in the standard range. Conversely, an increased,
respectively a decreased sodium concentration is found in serum due to a loss or gain
of water when there is a normal level of sodium.
An increased sodium level in serum occurs when there is:
o a decreased supply of liquid
o increased loss of water
o through the kidneys
O central diabetes insipidus
O renal diabetes insipidus
O osmotic diuresis (e.g. mannitin fusions)
o through the intestine
O infection deseases (especially dysentery and cholera)
o excessive supply of hypertonic saline solution(infusion therapy dosed too high)
o increase of aldosterone-induced sodium reabsorption
O primary hyperaldosteronism (CONN syndrome)
O secondary hyperaldosteronism
Reduced sodium level in serum occurs following:
o excessive supply of liquid without sufficient absorption of sodium
o excessive water supply with normal level of sodium in the organism
(for example: congestive heart failure)
o disturbance of sodium reabsorption caused by aldosterone deficiency
O suprarenal gland insufficiency (M. ADDISON)
O adrenogenital syndrome with saline loss (aldosterone insufficiency with high
grade enzyme defect)

Standard values:
o Adult: 135 - 148 mmol/L
o Newborn: 134 - 144 mmol/L
o Child: 138 - 144 mmol/L

Critical values(a):
o Na+ < 120 mmol/L
o Na+ > 160 mmol/L
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

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Clinical significance

Potassium

About 97% of potassium within the organism is intracellular. Transport into the cells
is regulated by the Na/K ATPase localized in the cell membrane. Only about 3% of the
potassium is contained in the extracellular fluid. Potassium is glomerularly filtered
and most of it (about 90%) is reabsorbed in the proximal tubule and in Henle's loop.
Reabsorption or excretion in the distal tubulus is influenced especially by aldosterone
and the blood pH value.
Due to the high intracellular concentration of potassium, the serum potassium values
do not always reflect the potassium level of the organism. Therefore, the data
obtained from the serum may be interpreted only with careful consideration of the
patient's clinical situation and acid-base status. Consider the following examples:
diabetic coma, during which the flow of potassium into the cell is reduced due to the
lack of insulin, and acute intoxication with heart glycosides with accompanying
inhibition of the Na/K ATPase membrane. In both cases exists, despite a more or less
greatly increased serum potassium level, intracellular potassium deficiency.

Increased potassium concentration in serum occurs during:

o decreased excretion through the kidneys
O acute and chronic kidney insufficiency (especially pronounced with oliguria
and anuria)
O Aldosterone deficiency with suprarenal gland insufficiency (M. ADDISON)
O dosage of potassium-saving diuretic
O oral potassium substitution with (possibly unknown) mild limitation of
kidney functions
o displacement between intracellular and extracellular potassium
O severe insulin deficiency
O intoxication with heart glycosides
O severe acidosis
O (each 0.1 reduction of the blood pH results in a rise in potassium of 0.4 to
1.2 mmol/L serum)
O malignant hyperthermia
o Reales of potassium on massive cell destruction
O hemolytic crisis
O transfusions with cold or very cold blood
O cytostatic therapy for leukemia and others
O burns
O severe soft tissue injuries
Hypokalemia is observed during:
o gastrointestinal potassium losses
O laxative abuse
O massive diarrhea
O fistulas in the area of the gastrointestinal tract
O villous papillary adenoma
O VERNER-MORRISON syndrome (pancreatic cholera)
o increased renal excretion

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Clinical significance

O primary hyperaldosteronism (CONN syndrome)

O secondary hyperaldosteronism
O cirrhosis of the liver (caused by decreased aldosterone breakdown)
O therapy with loop diuretics and thiazides
O CUSHING syndrome
O Aldosterone producing suprarenal gland carcinoma
O overdose of mineral corticoids
O renal tubular acidosis
o displacement between intracellular and extracellular potassium
O severe alkalosis
O insulin therapy for diabetic coma (potassium substitution required!)

Normal values:
o Adult: 3.5 – 4.5 mmol/L
o Newborn: 3.7 – 5.9 mmol/L
o Child: 3.4 – 4.7 mmol/L

Critical values(a):
o K+ < 2.8 mmol/L
o K+ > 6.2 mmol/L
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

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Clinical significance

Chloride

Chloride is the most important anion in bodily fluids. Chloride is located – like
sodium – mostly in the extracellular area. Erythrocytes represent the highest
intracellular content. The concentration of chloride in serum, like the level of sodium,
is held constant within tight limits in healthy people. Chloride is glomerulary filtered
in the kidneys and is tubularly reabsorbed by passively following the sodium.
Chloride may be exchanged for bicarbonates during disturbances to the acid/base
status, causing chloride to adopt the additional task (in addition to maintaining the
isotones in the extracellular area) of working with sodium to regulate the acid/base
status.
Changes to the chloride and sodium concentrations in serum usually occur in
parallel.
Exceptions to this occur during disturbances to the acid/base status caused by the
previously mentioned exchange of chloride for bicarbonates as well as during massive
chloride loss with gastric juices during extended periods of vomiting (hypochloremic
alkalosis).

Normal values(a):
o Adult: 98 - 107 mmol/L
o Newborn: 98 - 113 mmol/L
(a) Tietz Textbook of Clinical Chemistry, 3rd Edition 1999

Normal values (arterial blood at 37°C)(a):

o Women: 0.34 - 0.45 or 34 - 45 %
o Men: 0.34 - 0.48 or 34 - 48 %
o Newborn (3 - 7 weeks): 0.36 - 0.46 or 36 - 46 %
(a) Clinical Laboratory Diagnostics: use and assessment of clinical laboratory results, edited by Lothar
Thomas, M.D, Edition 1998

Critical values(a):
o Hct < 0.20 or 20 %
o Hct > 0.60 or 60 %
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

In patients suffering an extensive blood loss, during massive infusion therapy and during
complicated surgery, especially open-heart surgery, determination of the hematocrit value with the
conductivity method used in the cobas b 221 system can lead to incorrect results. Especially with
infusions with protein-free electrolyte solutions or when hyperosmolar solutions are used, the
measured hematocrit value can be significantly reduced. This artificially reduced hematocrit value
may lead to an unnecessary premature decision regarding transfusion.
If this is the case, we recommend either direct measurement of the hematocrit (micro centrifugation
or PCV) or indirect determination via the measurement of the total hemoglobin using the
calculated value Hct(c).
To take into account possible influences due to infusion solutions, the cobas b 221 system has special
correction algorithms for the calculation of patient results. These algorithms are particularly
optimized with Ringers solution. However for those patients receiving infusions other than Ringers
or whose hematocrit is pathologically low, false hematocrit measurement values cannot be
excluded. In these instances, the aforementioned limitations and evaluation of patient results must
be considered.

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Clinical significance

tHb (total hemoglobin concentration)

Hemoglobin is the main component of erythrocytes. It serves as the vehicle for

transportation of oxygen within the bloodstream and each gram/dL of hemoglobin
can carry 1.39 mL of oxygen. The oxygen combining capacity of the blood is directly
proportional to the hemoglobin concentration rather than to the number of red
blood cells (RBC), because some red cells contain more hemoglobin than the others.
Although oxygen transport is the main function of hemoglobin, it also serves as an
important buffer in the extracellular fluid.
Decreased hemoglobin values appear in connection with hemolytical reactions
caused by transfusions of untolerated blood, but can also be caused by a loss of blood
or a number of other factors.
Increased hemoglobin values found in the blood hemoconcentrations with
chronically obstructive pulmonary illnesses.
ctHb gives valuable information in an emergency situation if interpreted not in an
isolated fashion but in conjunction with other pertinent laboratory data.
tHb is used to screen for disease associated with anemia, to determine the severity of
anemia, to follow the response to treatment for anemia and to evaluate polycythemia.

Normal values (arterial blood at 37°C)(a):

o Women: 11.7 - 16.1 g/dL
o Men: 12.6-17.4 g/dL
o Newborn: 4 - 20 g/dL
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Critical values(a):
o tHb < 70 g/L or 7 g/dL
o tHb > 200 g/L or 20 g/dL
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

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Clinical significance

Oxygen saturation

Oxygen saturation is the measured portion of the oxyhemoglobin in total

hemoglobin.

Reference values(a):
o Adult: in arterial blood 95 – 98 %
in venous blood approx. 73 %
o Newborn: in arterial blood 40 - 90 %
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Critical values(a):
o SO2 < 80 %
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

The measurement of SO2 is used to judge oxygenation, usually in connection with

other parameters, for example PO2, PCO2 and hemoglobin.
For monitoring of patients with possible hypoxia(a) SO2-Werte > 90 % are acceptable.
In principle, SO2 measurements are better than estimated values (O2sat); however,
when using SO2 measurements during the presence of abnormal hemoglobins (for
example carboxyhemoglobin(b)) incorrect results may arise [for example, assuming a
comatose patient with 15 % COHb, an SO2 value of 95 % may be shown, although in
reality the level of oxyhemoglobin (FO2Hb) is only 80 % (100 % is the summation of
all hemoglobins)].
For this reason, the CLSI suggests evaluation of the dyshemoglobins(c) instead of a
clinical evaluation of a single SO2 value.

(a) Indicative for a decreased level of oxygen in blood

(b) COHb
(c) COHb, MetHB, SulfHb

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Clinical significance

Hemoglobin derivatives and bilirubin

A ε [L mmol cm ]
-1 -1
B Wavelength [nm]

Figure A-55 Absorption spectrum of the Hb derivatives and Bilirubin

Each hemoglobin molecule consists of four hemo groups each containing an iron
atom. This iron atom can either exist as two value (reduced) or three value (oxidized)
iron. In the two value state, each iron atom of the deoxygenized hemoglobin (HHb)
can be in the reversible molecular oxygen (O2Hb) or carbon monoxide (COHb).
With methemoglobin (MetHb), three value iron can be in the hydroxyl ions, cyanide
and sulfur components.
On account of their capability to transport oxygen, HHb and O2Hb is termed
functional hemoglobin. Carboxyhemoglobin, methemoglobin or sulfhemoglobin are
nonfunctional hemoglobin types.
The amount of hemoglobin loaded with oxygen in the total hemoglobin is termed the
oxyhemoglobin fraction (FO2Hb) and is used to estimate the amount of oxygen in
the tissue with tHb and PO2 to calculate the oxygen content.
The amount of hemoglobin loaded with oxygen in the functional hemoglobin is
determined by the PO2 and is defined as oxygen saturation (SO2).
The oxygen affinity of hemoglobin is primarily dependent on five factors:
temperature, pH, PCO2, concentration of 2.3 DPG and the hemoglobin type.
A limitation of the oxygen transport from the lung to hemoglobin, inadequate
circulation or shunt can cause a reduction of PO2 and oxygen saturation and finally a
decrease in oxygen transport to tissue.
Clinically, it is important to make a distinction between hypoxia (lack of oxygen in
tissue) and cyanosis (reduced oxygen content in blood through an abnormally high
concentration of deoxyhemoglobin or the formation of nonfunction hemoglobin
derivatives). Cyanosis occurs when the capillary content of deoxyhemoglobin exceeds
5 g/100 mL.

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Clinical significance

This situation can occur when the arterial hemoglobin is not saturated or the oxygen
acceptance of tissue is too high. Comparable degrees of cyanosis occur at
concentrations of 1.5 MetHb/dL blood. Abnormally high MetHb concentrations
generally result from drug and chemical reactions. Methemoglobin anaemia rarely
occurs at birth.

Oxyhemoglobin (O2Hb)
When each hemogroup of hemo-molecule is bound to an oxygen molecule, the
hemoglobin is termed oxyhemoglobin (O2Hb). The percentage of oxyhemoglobin (in
comparison to total hemoglobin) is termed the oxyhemoglobin fraction (FO2Hb) of
the total hemoglobin. The oxygen bound in this way forms the largest component in
the total blood oxygen content (approx. 98%).

Standard values (arterial blood at 37°C)(a):

o Adult: 90 - 95 % or 0.90 - 0.95
o Newborn: 40 - 90 % or 0.40 - 0.90
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Critical values(a):
o O2Hb < 80 %
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Desoxyhemoglobin (HHb)
Deoxyhemoglobin is hemoglobin whose two value iron molecule in the hemogroup is
capable of binding an oxygen molecule. The sum of deoxyhemoglobin and
oxyhemoglobin (those derivatives capable of transporting oxygen in the blood) are
termed function hemoglobin.

Standard values (arterial blood at 37°C)(a):

o Adult: 1.4 - 4.9 % or 0.014 - 0.049
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Carboxyhemoglobin (COHb)
Hemoglobin is capable of binding carbon monoxide to the same ratio as oxygen. This
means that a hemogroup can bind a carbon monoxide molecule. However, the
hemoglobin molecule has an affinity to carbon monoxide 200 - 300 times greater
than to oxygen. This is also the reason why very small quantities of carbon monoxide
can cause a fatal concentration of COHb in the blood. A concentration of
approximately 6% COHb has already be found in the blood of moderate smokers.
Concentrations of 10 - 20% in the blood cause headaches and a slight shortage of
breath.
A concentration of 30 - 40% causes weakness and visual faults. A concentration of
40 - 50% causes tachypnoea, tachycardia, ataxia and fainting. A concentration of
50 - 70% leads to seizures, coma and restricted heart and lung functions. Higher
concentrations are usually fatal.
Clinical diagnoses require CO oxymetry as the calculated oxygen saturation of blood
gas and acid-alkali measurements is confusingly high.

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Clinical significance

Small quantities of carbon monoxide are generated in the body by the conversion of
haem into biliverdin. This production of small quantities of endogenous carbon
monoxide is increased by hemolytic anaemia.

Standard values (arterial blood at 37°C)(a):

o Nonsmoker: 0.5 - 1.5 % or 0.005 - 0.015
o Smoker: 8.0 - 9.0 % or 0.080 - 0.090
(a) Labor und Diagnose; Lothar Thomas, 5th expanded edition 2000; Page 490

Critical values(a):
o COHb > 15 %
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Methemoglobin (MetHb)
Methemoglobin is created through oxidation of two to three value hemoglobin iron.
This reduces the oxygen binding capacity, as Fe3+ cannot bind oxygen reversibly. This
hemoglobin occurs increasingly in large amounts in chronic hypoxaemia and in
residential areas. Methemoglobin is also formed by a number of organic and
anorganic oxidation agents and pharmaceuticals.
MetHb also occurs in patients with inherited structural abnormalities of hemoglobin.
Concentrations of up to 20% are usually tolerable, concentrations of 30 - 40% cause
headaches, nausea and cyanosis. Concentrations above 40% require therapy;
normally intravenous treatment with methylene blue, which occurs as the activator of
NADPH dehydrogenase. In patients with known enzyme deficiencies, concentrations
of MetHb of up to 70% can occur.

Standard values (arterial blood at 37°C)(a):

o Adult: < 0.8 % or < 0.008
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Critical values(a):
o MetHb > 30 %
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

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Clinical significance

Total bilirubin (= neonatal)(a)

Neonatal bilirubin occurs in newborns. By increasing this primarily unconjugated
bilirubin, the so-called jaundice in newborns (Icterus neonatorum) occurs, which is
created due to transitional immaturity of the transport (e.g. ligandin) and coupling
systems (UDP glucuronic transferase) in the liver. In newborns, it leads to a
significant enteral backresorption of unconjugated bilirubin; the serum bilirubin
concentration increases post natum, reaches approx. 100 μmol/L (6 mg/dL) as
maximum for full-term newborns on the 3rd to 5th day, and then drops down to the
standard level in the 2nd to 3rd week. Higher bilirubin concentrations occur
particularly in premature newborns, and the icterus remains for a longer time
(hyperbilirubin anemia in newborns). Higher bilirubin concentrations are very
important in newborns since the "blood-brain-barrier" is not completely developed
yet and bilirubin may enter the brain. Bilirubin acts toxic on nerve cells so that high
bilirubin values in the first ten days after birth can lead to brain damage or death.
Depending upon the bilirubin concentration or whether the newborn is a healthy
full-term one or a premature one, icterus neonatorum is treated with photo therapy
or with exchange transfusions or with both options.

Normal values - Premature birth(a):

o Umbilical cord: < 2.0 mg/dL or < 34.2 μmol/L
o 0 - 1 day: < 8.0 mg/dL or < 137.0 μmol/L
o 1 - 2 days: < 12.0 mg/dL or < 205.0 μmol/L
o 3 - 5 days: < 16.0 mg/dL or < 274.0 μmol/L
(a) Tietz Textbook of Clinical Chemistry, 3rd Edition 1999; page 1803

Normal values - normal birth(a):

o Umbilical cord: < 2.0 mg/dL or < 34.2 μmol/L
o 0 - 1 day: 1.4 - 8.7 mg/dL or 24.0 - 149.0 μmol/L
o 1 - 2 days: 3.4 - 11.5 mg/dL or 58.0 - 197.0 μmol/L
o 3 - 5 days: 1.5 - 12.0 mg/dL or 26.0 - 205.0 μmol/L
(a) Tietz Textbook of Clinical Chemistry, 3rd Edition 1999; page 1803

Critical values(a):
o Bilirubin > 15.0 mg/dL or > 256.5 μmol/L
(a) Tietz Textbook of Clinical Chemistry, 3rd Edition 1999; page 1846

(a) Total bilirubin = unconjugated (free) and conjugated form

Urea/BUN

Urea is the most important catabolic product of the protein metabolism. It indicates a
limited or insufficient kidney function (reduced or nonexistant filtration in cases of
shock, heart failure, hypertonia, dehydration, tumours, etc.). The urea value is also an
important parameter for monitoring the protein supply in patients with
malfunctioning kidneys and for monitoring the therapy of dialysis patients with
kidney failures.

Normal values(a):
o Adult: Urea 2.1 - 7.1 mmol/L or 13.0 - 43.0 mg/dL
BUN 6.0 - 20.0 mg/dL
o Newborns: Urea 1.0 - 5.0 mmol/L or 6.0 - 30.0 mg/dL
BUN 2.9 - 14.0 mg/dL
(a) Labor und Diagnose; Lothar Thomas, 5th expanded edition 2000; Page 385

Critical values(a):
o Urea > 16.7 mmol/L or 100.0 mg/dL
(a) Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

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Operation B

6 Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
7 Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-31
8 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-63
9 Software modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-69
cobas b 221 system 6 Measurement
Contents

Measurement

In this chapter, all information necessary for carrying out measurements is described.

In this chapter Chapter 6

Preanalytics ...................................................................................................................... 5
Sample collection ...................................................................................................... 5
Sample acquisition .............................................................................................. 5
Anticoagulants ..................................................................................................... 5
Sample collection especially for tHb, SO2 and Hct measurement .................... 5
Sample collection especially for glucose / lactate measurement
(cobas b 221<5> system, cobas b 221<6> system only) ................................... 6
Sample collection especially for bilirubin measurement
(cobas b 221<2> system, cobas b 221<4> system, cobas b 221<6> system
only) ..................................................................................................................... 6
Sample containers ..................................................................................................... 7
Syringes ................................................................................................................ 7
Capillary tubes ..................................................................................................... 7
Roche MICROSAMPLER .................................................................................. 7
Clot catcher .......................................................................................................... 8
Sample handling ........................................................................................................ 8
Whole blood ........................................................................................................ 8
Serum ................................................................................................................... 9
Plasma .................................................................................................................. 9
Pleural fluid ......................................................................................................... 9
Interferences .................................................................................................................. 10
tHb/SO2 ................................................................................................................... 10
pH, ISE ..................................................................................................................... 11
MSS .......................................................................................................................... 13
Hb derivatives and bilirubin ................................................................................... 16
Limitations of clinical analysis ...................................................................................... 17
General ..................................................................................................................... 17

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Instructions for Use · Revision 10.0 B-3
6 Measurement cobas b 221 system
Contents

Electrolytes ............................................................................................................... 17
Blood gas .................................................................................................................. 17
tHb/SO2 ................................................................................................................... 18
Metabolites .............................................................................................................. 18
Hemoglobin derivatives and bilirubin ................................................................... 18
pH measurements in pleural fluid .......................................................................... 18
Measuring procedure .................................................................................................... 19
Syringe mode ........................................................................................................... 19
Capillary measurement ........................................................................................... 21
Aspirate from syringe .............................................................................................. 21
Use as default setup ................................................................................................. 23
Data input ................................................................................................................ 24
Mandatory input ............................................................................................... 24
Sample distribution ........................................................................................... 25
Result .................................................................................................................. 26
Last patients ....................................................................................................... 28
POC mode (Point-of-care mode) ........................................................................... 29

Roche Diagnostics April 2009

B-4 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Preanalytics

Preanalytics

Sample collection

Follow the usual applicable safety precautions when drawing blood samples. When handling blood
samples, there always exists the danger of transmission of HIV, hepatitis B and C viruses or other
pathogens transmissible by blood. Employ suitable blood sampling techniques in order to reduce
risk to personnel.
Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if
necessary mouth protectors, must be worn to prevent direct contact with biological working
materials. In addition, a face mask is required if there is a risk.

e Gudelines and additional information about handling blood samples are provided in CLSI
document M29-A3, "Protection of Laboratory Workers from Occupationally Acquired
Infections; Approved Guidelines - 3rd edition 2005" and other documents..

Sample acquisition
Only qualified personnel may perform the collection of blood needed for analytical
purposes.

The puncture site may never be squeezed! Mixing the blood sample with tissue fluid may lead to the
premature onset of clotting despite sufficient heparinization of the sample collection containers!
Incorrect sample collection or the use of an unsuitable sample collection container may lead to
errors and discrepancies in the measurement values.

e For detailed information about drawing blood and storing and handling blood samples,
refer to CLSI Document H11-A4, "Procedures for the collection of arterial blood
specimens; Approved Standard (Fourth Edition 2004)" and other documents.

Anticoagulants
The only clot inhibitors that may be used for analyses in the cobas b 221 system are
heparin salts. Other clot inhibitors, such as EDTA, citrate, oxalate, fluoride, and
ammonium-based materials have significant influence on the blood's pH and other
parameters and may not be used for this reason.

Sample collection especially for tHb, SO2 and Hct measurement

Whole blood, especially for the analysis of tHb, SO2 and Hct, must be thoroughly
mixed immediately before analysis in order to achieve consistent distribution of red
blood cells and plasma before insertion of the sample.
Carefully rotate the sample about two axis using your hand or a mechanical device or
insert a metal disk or ball in the syringe before collecting the sample. Shortly before
using the sample, carefully shake the syringe. The up and down motion of the disk or
ball inside the syringe cylinder ensures consistent mixing.
e Refer to CLSI document C46-A, "Blood gas and pH analysis related measurements;
Approved Guideline 2001".

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Instructions for Use · Revision 10.0 B-5
6 Measurement cobas b 221 system
Preanalytics

Sample collection especially for glucose / lactate measurement (cobas b 221<5> system,
cobas b 221<6> system only)
Glucose

Patient preparation: 12 hr. fasting period for blood glucose. Optimal postprandial blood sampling is 1 hr.
after ingestion of food.
Samples should be analyzed immediately after collection, since the sample
metabolism causes a decrease in the glucose concentration within a few minutes of
sample collection. If immediate analysis is not possible, the blood sample must be
centrifuged immediately and the excess serum or plasma must be separated by
pipette.
Plasma and serum samples collected in this manner and stored under refrigeration
are suitable for glucose analysis for up to 24 hours.

Lactate

Patient preparation: Collection after physical rest (at least 2 hours). Even minor physical activities will lead
to an increase in lactate concentration.
Samples should be analyzed immediately after collection, since the sample
metabolism causes an increase in the lactate concentration within a few minutes of
sample collection. If immediate analysis is not possible, the blood sample must be
centrifuged immediately in a cooled centrifuge and the excess serum or plasma must
be separated by pipette.
Plasma and serum samples collected in this manner and stored under refrigeration
are suitable for lactate analysis for up to 24 hours.
There are significant arteriovenous differences depending on forearm activity and
oxygenation of the forearm muscle. Immediately following the collection of the
sample, the protein in the sample must be removed using ice-cold perchloric acid.
If glycolysis inhibitors are used, heparin blood can be processed without removing
the protein. Such a sample is stable up to 2 hours after collection. Otherwise, the
supernatant lactate concentration after centrifugation remains constant for 24 hours
if stored under refrigeration.

Sample collection especially for bilirubin measurement (cobas b 221<2> system,

cobas b 221<4> system, cobas b 221<6> system only)
Whole blood, especially for the analysis of bilirubin, must be treated as a light
sensitive sample:
o Transport of the sample container protected from light
o Avoid direct sunlight
Samples should be analyzed immediately after collection.

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B-6 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Preanalytics

Sample containers

We recommend using the sample containers offered by Roche Diagnostics.

Syringes
If using another manufacturer's product with liquid heparin as a clot inhibitor, the
collection container should not be larger than required for the blood volume. This
will minimize the effects of the clot inhibitor on the thinning of the blood. Plastic
syringes are normally used, but there are cases when the use of plastic syringes is not
appropriate, for example, when PO2 values are expected to be outside the normal
range. If very high PO2 values are expected, the sample should be analyzed as quickly
as possible after the sampling.

Use only heparinized syringes. Improper use of syringes with liquid heparin will affect the
parameters, especially the ISE parameters!

Capillary tubes
Depending on instrument configuration, capillary tubes must have a minimum
volume of 115 μL, 140 μL or 200 μL.
Capillary tubes with ceramic sealing caps should not be used because the fracture that
forms when opening the capillary can damage the fill port of the cobas b 221 system.
Only glass capillary tubes with heat-polished ends or the plastic capillary tubes
offered by Roche Diagnostics may be used in order to prevent damage to the
instrument.
When using stirring rods like those offered by a few manufacturers, remove these rods
before inserting the sample in order to avoid clogging the sample path of the
cobas b 221 system .

Roche MICROSAMPLER (a)

The Roche MICROSAMPLER was developed for the technical facilitation of taking
samples of arterial blood.
The Roche MICROSAMPLER, which consists of two capillary tubes (220 μL) in a
plastic container, is ideally suited to a traumatic arterial blood collection.
Each laboratory should document the permissibility of sample containers that are
used. These products vary from manufacturer to manufacturer and sometimes from
lot to lot.

The use of sample containers or clot inhibitors other than those manufactured by Roche Diagnostics
may lead to adulteration of the samples and errors and differences in the measurement values.
Roche developed a specialized sample collection container for this purpose and recommends its use
for this reason.

(a) is a trademark of Roche

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Instructions for Use · Revision 10.0 B-7
6 Measurement cobas b 221 system
Preanalytics

Clot catcher
To prevent a blockage of the sample path, the use of a clot catcher is recommended for
measuring critical blood, e.g. blood from newborns taken from earlobes and heels.
The clot catcher (coagulate trap), which is placed on the top of the syringe or
capillary, prevents blood clots and tissue particles from entering the
cobas b 221 system.

Clot catchers are not suitable for measurements in "Aspiration from syringe" mode!

Sample handling

Whole blood
Withdraw whole blood samples using heparinized syringes, capillaries, or the
Roche MICROSAMPLER and analyze the samples as soon as possible after sampling.
Remove air bubbles from the sample collection container immediately after the
sampling procedure.
Immediately after withdrawing the sample with syringes, thoroughly mix the sample
with anticoagulant. This can be done by rolling the sample between both hands or
shaking. Properly label the samples, following the standard documentation
procedure.

Glass capillary tubes o Samples that are measured within 15 minutes may be retained at room
temperature.
o If unable to measure samples within 15 minutes, place them temporarily in ice
water. Complete the measurement within 30 minutes (but not after more than
60 minutes).
o Samples with a PO2 level above 200 mmHg (26 kPa) should be collected in a glass
container if the measurement can not be performed within 15 minutes.

Plastic capillary tubes If unable to measure samples immediately store the sample at room temperature for
no longer than 30 minutes.

When using capillaries analyze samples for tHb, SO2, Hct, glucose and lactate measurements
immediately after sampling to ensure correct and accurate measurement results.

Despite proper sampling procedures, errors can arise in the blood gas analysis:
o due to insufficient mixing of the sample after sampling and before the
measurement
o due to ambient air contamination caused by air bubbles that are not removed after
sampling
o due to changes in metabolism in the sample

Roche Diagnostics April 2009

B-8 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Preanalytics

Serum
After the appearance of spontaneous clotting, process the sample in a centrifuge to
separate the cellular, solid components and the fibrin from the watery serum. Transfer
the serum to a suitable sample container and seal.
If it is necessary to store the sample, close the sample container tightly and cool it to
+4 - +8 °C. If a sample has been cooled, warm it to room temperature (+15 - +33 °C)
before analysis.

Plasma
Plasma samples are obtained by centrifuging heparinized whole blood, during which
the cellular components of the blood are removed from plasma.
Complete the analysis as quickly as possible.
If immediate lactate analysis is not possible, the blood sample must be centrifuged
immediately in a cooled centrifuge.
If it is necessary to store the sample, close the sample container tightly and cool it to
+4 - +8 °C. If a sample has been cooled, warm it to room temperature (+15 - +33 °C)
before analysis.
Plasma samples older than 1 hour must be re-centrifuged in order to remove fibrin
clumps that may have formed.

Pleural fluid
The procedure for handling pleural fluids is the same as for plasma samples.

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Instructions for Use · Revision 10.0 B-9
6 Measurement cobas b 221 system
Interferences

Interferences

The measuring module and measuring sensors were tested with respect to their
interference stability with the given chemical substances and pharmaceuticals.
Respective concentrations of the interference substances were added to the whole
blood samples, as suggested by the CLSI, and then measured again.

(I) Control serum + interference substance

(K) Control serum
MV Mean value
SD Standard deviation

tHb/SO2

Substance tHb SO2

Indocyanin green 5 mg/L
MV (I)-(K) ± SD (n=4) 3.83 ± 0.15 --------------
MV (I) 19.40 --------------
MV (K) 15.60 --------------
Intralipid 10 g/L
MV (I)-(K) ± SD (n=4) 2.23 ± 0.17 --------------
MV (I) 17.23 --------------
MV (K) 15.00 --------------
Methylene blue 30 mg/L
MV (I)-(K) ± SD (n=4) -------------- -25.20 ± 1.47
MV (I) -------------- 75.73
MV (K) -------------- 99.90
Lipofundin 10 g/L
MV (I)-(K) ± SD (n=4) 1.33 ± 0.25 --------------
MV (I) 16.30 --------------
MV (K) 14.98 --------------
Table B-1 Interferences tHb/SO2 module

Roche Diagnostics April 2009

B-10 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Interferences

pH, ISE

Substance pH Ca K
Aspirin (Acetylsalicylic acid) (100 mg/100 mL)
MW (I)-(K) ± SD (n=16) -------------- 0.16 ± 0.01 --------------
MW (I) -------------- 1.22 --------------
MW (K) -------------- 1.06 --------------
Bovine albumin (6 g/100 mL)
MW (I)-(K) ± SD (n=16) -------------- 0.30 ± 0.02 --------------
MW (I) -------------- 1.34 --------------
MW (K) -------------- 1.03 --------------
Dobesilate (20 mg/100 mL)
MW (I)-(K) ± SD (n=16) -------------- -------------- 1.06 ± 0.02
MW (I) -------------- -------------- 6.16
MW (K) -------------- -------------- 5.09
Glycolic acid (50 mg/dL)
MW (I)-(K) ± SD (n=16) -------------- 0.15 ± 0.00 --------------
MW (I) -------------- 1.24 --------------
MW (K) -------------- 1.09 --------------
Glycolic acid (100 mg/dL)
MW (I)-(K) ± SD (n=16) -0.94 ± 0.02 0.31 ± 0.02 --------------
MW (I) 6.93 1.39 --------------
MW (K) 7.87 1.09 --------------
Glycolic acid (200 mg/100 mL)
MW (I)-(K) ± SD (n=16) -1.08 ± 0.03 0.20 ± 0.01 --------------
MW (I) 6.56 1.29 --------------
MW (K) 7.65 1.08 --------------
Potassium thiocyanate (23.2 mg/100 mL)
MW (I)-(K) ± SD (n=16) ------------- ------------- 2.25 ± 0.02
MW (I) ------------- ------------- 6.17
MW (K) ------------- ------------- 3.91
Potassium thiocyanate (232 mg/100 mL)
MW (I)-(K) ± SD (n=16) ------------- ------------- -------------
MW (I) ------------- ------------- -------------
MW (K) ------------- ------------- -------------
Magnesium nitrate (128.2 mg/100 mL)
MW (I)-(K) ± SD (n=16) 0.26 ± 0.01 ------------- -------------
MW (I) 1.24 ------------- -------------
MW (K) 0.98 ------------- -------------
Table B-2 Interferences pH, ISE

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 B-11
6 Measurement cobas b 221 system
Interferences

Substance Ca Na K Cl
Sodium bromide (102.9 mg/dL)
MW (I)-(K) ± SD (n=16) ------------- ------------- ------------- 14.81 ± 3.87
MW (I) ------------- ------------- ------------- 118.38
MW (K) ------------- ------------- ------------- 103.58
Sodium citrate. diluted (1000 mg/100 mL)
MW (I)-(K) ± SD (n=16) -1.05 ± 0.02 60.79 ± 1.36 -0.58 ± 0.04 -------------
MW (I) -0.01 204.59 3.36 -------------
MW (K) 1.04 143.80 3.95 -------------
Sodium chloride (140 mmol/L)
MW (I)-(K) ± SD (n=16) 0.19 ± 0.01 37.23 ± 0.45 ------------- 28.46 ± 4.20
MW (I) 1.28 179.63 ------------- 132.59
MW (K) 1.08 142.40 ------------- 104.13
Sodium chloride, diluted (120 mmol/L)
MW (I)-(K) ± SD (n=16) ------------- 16.29 ± 0.43 ------------- 13.72 ± 2.04
MW (I) ------------- 158.43 ------------- 119.86
MW (K) ------------- 142.14 ------------- 106.14
Sodium chloride, diluted (130 mmol/L)
MW (I)-(K) ± SD (n=16) 0.12 ± 0.01 25.73 ± 0.44 ------------- 20.90 ± 2.75
MW (I) 1.24 167.99 ------------- 124.35
MW (K) 1.12 142.26 ------------- 103.45
Sodium hydrogen carbonate (336 mg/100 mL)
MW (I)-(K) ± SD (n=16) -0.14 ± 0.01 32.45 ± 0.61 ------------- -------------
MW (I) 1.00 175.98 ------------- -------------
MW (K) 1.14 143.53 ------------- -------------
Table B-3 Interferences pH, ISE

Roche Diagnostics April 2009

B-12 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Interferences

Instructions for Use · Revision 10.0 B-15
6 Measurement cobas b 221 system
Interferences

Hb derivatives and bilirubin

Substance HHb MetHb Bilirubin

Evans blue (5 mg/L)
MW (I)-(K) ± SD (n=8) 0.00 ± 0.02 0.68 ± 0.05 ----------------
MW (I) 0.03 1.34 ----------------
MW (K) 0.02 0.65 ----------------
Indocyanine (5 mg/L)
MW (I)-(K) ± SD (n=8) 0.01 ± 0.02 -0.06 ± 0.06 ----------------
MW (I) 0.03 0.56 ----------------
MW (K) 0.02 0.63 ----------------
Intralipid (10mg/L)
MW (I)-(K) ± SD (n=8) 0.00 ± 0.02 ---------------- ----------------
MW (I) 0.03 ---------------- ----------------
MW (K) 0.03 ---------------- ----------------
Lipofundin (10mg/L)
MW (I)-(K) ± SD (n=8) -0.01 ± 0.02 ---------------- ----------------
MW (I) 0.02 ---------------- ----------------
MW (K) 0.03 ---------------- ----------------
Methylene blue (7.5 mg/L)
MW (I)-(K) ± SD (n=8) 0.00 ± 0.02 -1.09 ± 0.05 ----------------
MW (I) 0.02 -0.44 ----------------
MW (K) 0.02 0.65 ----------------
Methylene blue (30 mg/L)
MW (I)-(K) ± SD (n=8) 0.01 ± 0.02 -4.61 ± 0.20 -3.02 ± 0.14
MW (I) 0.03 -3.83 17.63
MW (K) 0.02 0.77 20.65
Propofol (2µL/mL)
MW (I)-(K) ± SD (n=8) 0.00 ± 0.03 ---------------- ----------------
MW (I) 0.03 ---------------- ----------------
MW (K) 0.03 ---------------- ----------------
Table B-6 Interferences Hb derivates and Bilirubin

Roche Diagnostics April 2009

B-16 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Limitations of clinical analysis

Limitations of clinical analysis

The determined performance data can be influenced by known and unknown factors
as described below.
e For details, see section Interferences, tHb/SO2 on page B-18 and Metabolites on page B-18.

General

The literature lists various substances which may negatively impact upon the
measurement result of the blood and plasma/serum sample material. A detailed
discussion of these phenomena can be found at different places in the technical
literature. With respect to the cobas b 221 system, an attempt was made to identify or
evaluate these possible influences. But since it is not possible to check all medication
or substances, the user should be immediately informed with abnormal deviations of
the measurement results—as with every clinical analysis—and evaluate the complete
picture of the patient or perform expanded measurements in his own laboratory, if
necessary.

Ensure that the selected sample type matches the sample to be measured. If the sample and sample
type do not match, incorrect measurements will result.

Electrolytes

It is well-known, for example, that the potassium value of a patient can vary by up to
20% from the normal state, simply because of the presence of a pressure bandage.
Hence, taking a blood sample while a pressure bandage is present should be avoided.
In general, a local hemolysis caused by pressure should be avoided prior to taking a
blood sample.

Blood gas

A whole blood sample is prefered for performing these measurements. Contaminating

the blood sample with air will significantly distort the measurements. The notes and
restrictions in the section Preanalytics should be observed in any case.(a)
e see section Preanalytics on page B-5

(a) Mahoney JJ, Wong RJ, Van Kessel AL: Reduced Bovine Hemoglobin Solution Evaluated for Use as a
Blood Gas Quality-Control Material. Clin.Chem. 39/5, 874-879 (1993).

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 B-17
6 Measurement cobas b 221 system
Limitations of clinical analysis

tHb/SO2

The cobas b 221 system tHb measurement is sensitive to the sedimentation rate of red
blood cells, particularly if the sedimentation rate is very high, as it may be the case,
e.g. with special pathological samples. The measurement procedure of the
cobas b 221 system is designed so that this effect does not occur during the
measurement. However, this assumes an extensive and proper rolling of the sample
container to avoid this type of sedimentation in the sample.
e see section Preanalytics on page B-5

Metabolites

The most important influence in glucose/lactate determination is the treatment of the

sample until the measurement due to the glycolysis in the erythrocytes of the blood
sample.
e Detailed information about the correct treatment of samples are listed in the section
Preanalytics on page B-5.

The following principle holds: Perform metabolite measurements from heparinized

whole blood as quickly as possible or centrifuge the sample as quickly as possible for
plasma extraction and immediately pipette off the supernatant of the sample.
The cobas b 221 system metabolite measurement is performed with an active
interference correction. As such, the glucose or lactate measurement features an
additional integrated sensor that largely eliminates any possible occurring
interferences endogenously (e.g. uric acid) or exogenously (e.g. actetylsalicylic acid).
To achieve the highest possible perfection in interference compensation, the
compensation sensor with the actual biosensors is adjusted daily as part of the system
calibration. The influence of the most important known interferents was determined
during development.
e summarized in section MSS on page B-13.

In spite of these interference compensation sensors, a metabolite determination is

only possible with samples with an approximate physiological ion background and
pH value as well as a mean physiological buffer capacity of the sample.

Hemoglobin derivatives and bilirubin

As well as the restrictions applicable to determining the blood gases, measurement of

the Hb derivatives and bilirubin by light-absorbing substances in the blood sample
(e.g. contrast agent) can be disrupted. The influence of the most important known
interferents was determined during development
e summarized in section Hb derivatives and bilirubin on page B-16.

pH measurements in pleural fluid

Only pH measurement results are specified in pleural fluids. Any other measurement results that
are output do not conform to specifications.

Roche Diagnostics April 2009

B-18 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Measuring procedure

Measuring procedure

QC measurements must be performed in their entirety (i.e., all three QC levels must be measured).
Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient
measurements, which may result in incorrect clinical decisions, possibly endangering the patient's
health.

Before starting a measurement, all parameters must be ready for measurement.

Depending on the setting, the operator ID and a password may be required.
e see Reference Manual chapter Software modes, section Setup

You have the option of measuring samples from syringes (without needles), ampoules
and capillaries.

Syringe mode

Improper heparinization of syringes with liquid heparin may cause erroneous results.
ISE parameters are particularly susceptible.

1 Securely attach the syringe to the fill port.

If the position of the syringe is correct, the T&D disk will be backlit in green.

Figure B-1

Using syringe with an excentric tapered tip make sure that the tapered tip is in lower position while
attaching the syringe to the fill port!

e For details, see Figure B-2 on page B-20!

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Instructions for Use · Revision 10.0 B-19
6 Measurement cobas b 221 system
Measuring procedure

Figure B-2

2 The following screen appears:

Figure B-3

3 Inject the sample slowly until the signal sounds.

Do not press the [Aspirate sample] button, or the sample will spill out — danger of infection!

4 Detach the syringe after the message "Remove sample container" appears.
5 The measurement starts.

Roche Diagnostics April 2009

B-20 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Measuring procedure

Capillary measurement

Only glass capillary tubes with heat-polished ends or the plastic capillary tubes offered by Roche
Diagnostics may be used in order to prevent damage to the instrument.

e see Capillary tubes on page B-7 in the section Sample containers

1 Insert the capillaries or the Roche MICROSAMPLER into the fill port.
If the position of the capillary is correct, the T&D disk will be backlit in green.

Figure B-4

2 Press the [Aspirate sample] button.

e see Figure B-3 on page B-20

3 Detach the capillaries or the Roche MICROSAMPLER after the message "Remove
sample container" appears.
4 The measurement starts.

Aspirate from syringe

This option is activated in the [Setup] mode.

1mL syringes cannot be used for the software mode "Aspirate from syringe"!

A minimum fill height of 15 mm is required!

e see Chapter 4 Specifications, section Sample volumes, Table A-72 page A-87!

Press the following buttons:

h Setup > Instrument > Switch > Aspirate from syringe
This option is now also displayed at the top level of the analyzer mode.

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Instructions for Use · Revision 10.0 B-21
6 Measurement cobas b 221 system
Measuring procedure

Figure B-5

1 Pressing or turns the T&D disk to the

corresponding position.
2 Securely attach the syringe to the fill port.
If the position of the syringe is correct, the T&D disk will be backlit in green.

Figure B-6

3 Press the [Aspirate sample] button.

4 The sample is aspirated from the syringe.
5 Detach the syringe after the message "Remove sample container" appears.
6 The measurement starts.

Roche Diagnostics April 2009

B-22 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Measuring procedure

Use as default setup

It is possible to set either the "Capillary mode" or "Aspirate from syringe" as standard
measurement method.
Press the following buttons.
h Setup > Instrument > Switches
1 Press [Activate aspirate from syringe].
2 Activate [Use as default setup].

Figure B-7

3 Activate "Capillary mode" (= aspirate with capillary or inject sample) or "Activate

aspirate from syringe" as the standard setting.
Depending on which mode has been selected as the standard setting, the T&D
disk turns to the position intended for it at the end of a measurement.
The following setting combinations are possible:
o Capillary mode
o Switch between "Activate aspirate from syringe" and "Capillary mode"
o Standard setting "Activate aspirate from syringe":
For the next measurement "Capillary mode" can be switched to.
o Standard setting "Capillary mode":
For the next measurement, "Activate aspirate from syringe" can be switched to.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 B-23
6 Measurement cobas b 221 system
Measuring procedure

Data input

During measurement, various patient, operator, and sample-specific data may be

entered.

Figure B-8

Use the buttons / to select an entry.

Press [Edit input value] to enter data or change existing data.
A keyboard appears on the screen — enter the "Patient ID".

If the patient already exists in the cobas b 221 system database, patient-specific data appears in the
respective lines.
Scanning in patient and user data is possible by means of a barcode scanner!

The user must carry out a plausibility check for all barcode data read in and displayed by the
instrument!

If the patient is not yet registered, press [New patient] and the patient related data will
be stored.
The "Remark" input field is limited to 25 characters.

Mandatory input
If mandatory input fields are defined ([Setup] > [Display & reports] >
[Measurement] > [Input values]), they are displayed in a red font.
An entry must be made in these fields; otherwise, the measurement values are
discarded.

If a standard value is defined as mandatory input, it must be confirmed or edited, if necessary.

Roche Diagnostics April 2009

B-24 Instructions for Use · Revision 10.0
cobas b 221 system 6 Measurement
Measuring procedure

Sample distribution
This function can be used to monitor the sample distribution during measurement
(see below).

Figure B-9

Figure B-10

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 B-25
6 Measurement cobas b 221 system
Measuring procedure

Result
After the measurement is completed and all data is entered, the results are displayed
on the screen and printed out.

Figure B-11

[Input values] A subsequent correction of the input values is still possible after the conclusion of the
measurement by pressing the [Input values] button.

If a connection to an ASTM host and the function "Send immediately" (Setup > Interfaces >
ASTM) is activated, the input values cannot be corrected after the measurement is finished!

e see Reference Manual chapter 2 Description of system components, section ASTM.

[Select report] Select one of the predefined forms ([Setup] > [Display & reports] > [Measurement] >
[Measurement report])

[Print] Starts the printout of the measurement report.

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Measuring procedure

[Patient trending map] By means of this map, the course of individual parameters (measurement and
calculation values) of a patient over any required period (standard setting = one day)
can be shown and printed out.

Figure B-12

Should another start/end date and/or another start/end time be required, it can be
entered manually (see above).
For reasons of clarity, only four parameters can be selected from the selection list (see
above), from which the map is then made.
In order to obtain a clear representation, the result of the first measurement in the
observation period of the respective parameter is standardized to 100%, and is thus
the basis for the trend curve.
If only one parameter was selected the representation takes place in absolute values
and in the adjusted unit. As soon as a further parameter is selected changes the
representation on the 100% standardization of the respective parameter.
Furthermore, when only one parameter is selected, the display is in absolute values
and in the configured unit. As soon as another parameter is selected, the display
switches to 100% scaling of the relevant parameter.
The "Patient trending map" can be called up either immediately after measurement or
later in the data manager.

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Measuring procedure

[Acid base map] If PCO2 and pH-measurements are available, the diagram can be displayed and
printed.

Figure B-13

There is also the possibility of displaying and printing out an acid base trend diagram
in the data manager.
e For a detailed description refer to the Reference Manual chapter 4 Data manager, section
Measurement.

Last patients
The last patients whose samples have been measured are listed here.

Figure B-14

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Measuring procedure

POC mode (Point-of-care mode)

The POC mode is a user interface simplified to suit the needs of POC users, with very
restricted user rights.

Before the POC mode is activated, the newly created POC profile in the profile management must
be assigned to a "POC user" user profile.

e see Reference manual chapter 3 Setup, section Security.

h Setup > Security > Instrument functions

Figure B-15 POC mode

In the POC mode there is no possibility for interrupting any actions started. Persons
registered as POC users are able to call up the functions offered on the "Ready" screen,
all the functions under "Info" and if available, also the video sequences.

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6 Measurement cobas b 221 system
Measuring procedure

Figure B-16 Ready screen at POC mode

The following control material is recommended:

For BG, ISE, Glu, Lac, Hct, tHb/SO2 (cobas b 221<1> system,
cobas b 221<3> system, cobas b 221<5> system):
o COMBITROL TS+
o AUTO-TROL TS+ (AutoQC material)
For BG, ISE, Glu, Lac, Urea/BUN, COOX/bilirubin (cobas b 221<2> system,
cobas b 221<4> system, cobas b 221<6> system):
o COMBITROL PLUS B
o AUTO-TROL PLUS B (AutoQC material)

Colour code of the ampoules o Level 1 - red marking line

o Level 2 - yellow marking line
o Level 3 - blue marking line
The target areas listed in the package text should be taken as 2 SD areas
(SD = standard deviation) (e.g. for PO2, 2SD = 12 mmHg, 1SD = 6 mmHg).
The QC measurement results within the target value range ± 2SD are acceptable.
If QC measurement results fall outside the target value range ± 3SD, the parameter
must be locked
e see section Important information concerning the analysis of QC measurement results on
page B-35!

QC measurement results that are greater than the target value ± 2SD, but less than the
target value ± 3SD , cause QC warning and must be treated accordingly.
e see sectionImportant information concerning the analysis of QC measurement results on
page B-35!

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Important information concerning the analysis of QC measurement results

Important information concerning the analysis of QC

measurement results

Ensure, that "Multirules" rule 1 and 2 are activated and the QC consequence "QC lock" was
assigned to the parameters!

e see section Multirules on page B-53

e see section QC consequences on page B-55

The evaluation depends upon which SD areas are featured in the QC measurement
results:
o Measured value is within the target value range ± 2SD
The parameter is acceptable.
The QC measurement results are within ± 2SD from the target value and the
parameter is/remains activated for measurements.
o Measured value is outside the target value range ± 3 SD
Consequence: A "QC lock" is assigned to the parameter.
The QC measurement result is not acceptable. The parameter is locked for
additional measurements and may only be released for further patient
measurements, after the cause of the lockout has been determined and the error
has been corrected.
e see section Remove the QC lock on page B-56
o Measured value is larger than target value ± 2SD, but smaller than target
value ± 3 SD
Consequence: A "QC warning" is assigned to the parameter.
The user must now analyze the QC measurement results in accordance with
applicable regulations or repeat the measurement.
Call up the QC statistics in the QC database to aid in the analysis.
e see Chapter 9 Software modes, section QC measurements on page B-84

The analysis can be automated by activating additional multirules.

e see section Multirules on page B-53

If the result of the repeated measurement is greater than target value ± 2SD, but
less than target value ± 3SD, the parameter is not locked, but must not be used for
further patient measurements.

To eliminate the error, replace the electrode and/or contact customer support.

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Instructions for Use · Revision 10.0 B-35
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Material setup

Material setup

Take the lot, expiration date, sample type and target values (ranges) as well as the corresponding
barcodes from the text included in the recommended QC material.

The QC material must be defined prior to the QC measurement.

Select the QC material according to the instrument version!

The barcode scanner facilitates easy entry of the required information.

Press the following buttons:
h Setup > QC materials > QC materials

Figure B-18

To define a new QC material, read in the material code with the barcode scanner from
the packing insert or press the [New] button and enter the information manually.
The material code contains the information for the material, the proper level, lot
number, expiration date, and sample type.

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Material setup

Figure B-19

Press [Ranges] and read in the additional barcodes for the target values.
The cobas b 221 system automatically assigns these.
If no barcode scanner is available, the target values can also be entered manually.
Press [Set] to edit a previously defined material/level combination.

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Material setup

Material assignment – AutoQC materials

The selected AutoQC material must be assigned prior to the AutoQC measurement.
Select the material and level to be assigned and select [Mat].

Figure B-20

Figure B-21

The selected material/level combination is assigned to a mat (A-F) by pressing [Set].

Press the "Back" button to save the material assignment.

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Material setup

Inserting the AutoQC mats

Starting with the top level of the Analyzer mode, insert the ampoule mats in the
ampoule holder as follows:
1 Pull out the AutoQC drawer.
The following screen appears:

Figure B-22

2 Take a full mat (20 ampoules) from the package.

3 Turn the mat so that the necks of the ampoules face down. Gently wave but do not
shake the mat and ensure that the necks of the ampoules are free of air bubbles.

Figure B-23 AutoQC-Mat

4 Place the mat in the defined position of the ampoule block so that the ampoules
are no longer visible.

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Material setup

5 Press [Refill].
The following question appears:

Figure B-24

6 Press [Yes] – if the mat is replaced with a new one of the same lot. The number of
the ampoules is set to 20.

Figure B-25

7 In case the mats that are not completely filled press [Details]. By pressing the
corresponding key the status of the selected ampoule can be changed and/or the
ampoules to be measured can be selected (blue - full, gray - empty).

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Material setup

Figure B-26

This function can also be used when full ampoules are removed from the mat for
manual measurement
8 Repeat the procedure for all mats.
9 Close the AutoQC-drawer.

QC timing

Depending on the selected material/level, this function is used to select the start
time(s) for the AutoQC measurement(s) and/or the time for performing a manual
QC measurement. After reaching the set time, a note appears in the instruction
window.
Press the following buttons:
h Setup > Times & intervals > QC timing

Figure B-27

A little marker ("QC") on the time scale indicates the defined start time(s) and for a
better coordination with the QC timing a little marker on the time scale also indicates

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Material setup

the defined calibration intervals. Small red-colored point - System calibration,

small green-colored triangle - 2P calibration.

Setting start time(s)

Select the day from the "Day of Week" list on which the QC measurement should be
performed.

"New" Enter start time, material and measurement repeats.

Press [Use another material] to define the material used for a possible measurement
repeat.
Press [Repeats] to define the number (0-3) of QC measurements to be repeated.

"Edit" Change or modify start time, material and measurement repeats. Press [Use another
material] to define the material used for a possible measurement repeat.

"Delete" Delete the marked entry from the list.

"Copy daily profile" The start time(s) will be copied to a cache (see "Paste daily profile").

"Paste daily profile" Select another day of the week and press [Paste daily profile] - the cached entry will be
entered for the new day of the week.

Change lot (applies only to AutoQC measurements)

By means of this function, a follow-up material of a new lot can be assigned to a

current Material/Level Combination (= main material). The defined starting times
for the AutoQC measurement(s) are thus taken over immediately after the current
material has been used up for the follow-up material of a new lot. This means there is
no interruption of the AutoQC measurements.
First define the new material (follow-up material), assign the material and insert the
mats.

Material setting / Material assignment – Follow-up material

The follow-up material has the same material name and QC level, but a different batch number.

Press the following buttons:

h Setup > QC Material > QC Material
1 Read in the material code from the package insert using the barcode scanner or
press the [New] button and manually enter the information.
2 Press the [Ranges] button.
3 Read in the other barcodes for the target values.
4 Select the material/level combination and press [Mat].
5 If no mat position is available, a mat position of the main material that does no
longer contain an ampoule must be deleted (to find out which mat position can
be deleted, press [Info] > [AQC status]).

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Material setup

6 Press [Set] and the selected material/level combination will be assigned to a mat
(A-F).

Press this button to store the assignment.

7 Press the "Analyzer" button to change to the analyzer mode.

8 Pull out the AutoQC drawer.
9 Take a full mat of the follow-up material from the package.
10 Turn the mat so that the necks of the ampoules face down. Gently wave the mat
twice, but do not shake it. Ensure that the necks of the ampoules are free of air
bubbles!
Make sure there are no air bubbles in the ampoule necks!
11 Place the mat in the previously defined position (A-F) of the ampoule block.
12 Press [Refill].
13 Close the AutoQC drawer.

At least one mat of the replacement material must be present in the AutoQC module.
No QC times should be assigned to the follow-up material. The defined starting times for the
AutoQC measurement(s) are taken over immediately after the current material has been used up
for the follow-up material of a new lot.

14 Next, press the following button:

h Setup > QC material > Change lot
15 Select the material/level combination to which a replacement material of a new lot
must be assigned.

For this material/level combination (= main material), at least one QC measuring time must be
defined so that a follow-up material can be assigned.

16 In the "New lot number" window, select the lot of the replacement material.
17 Press [Select new lot number] – the new lot becomes the follow-up material of the
current material.

Press this button to store the assignment.

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QC setup wizard

QC setup wizard

This chapter describes the software supported setup of QC material step by step.

To start the QC setup wizard, the user must have the right to change QC materials. Otherwise the
start is refused with the message "Insufficient user privileges!"

e see Reference Manual chapter 3 Setup, section Security!

Starting with the top level of the analyzer mode:

1 Open the AQC drawer.

Figure B-28

2 Press [Yes]. Following screen appears:

Figure B-29

To execute, follow the additional instructions on screen for completing the other
fields!

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QC setup wizard

Scanning the material code

The system determines whether a new QC material or a previously installed one with
the same lot number is being scanned.

New QC material
There is the ability to scan in up to 4 different materials. If this number is reached,
you first have to delete an existing AQC material ([Setup] > [QC material] >
[Delete]). A corresponding prompt appears on the screen.

Already installed AQC material

AQC material with the same lot If the barcode of a previously installed QC material with the same lot number is
number scanned, the procedure is continued and a corresponding information message is
displayed.

AQC material with different lot If the barcode for a previously installed AQC material with a different lot number is
number scanned in, after you press the [Continue] button, you can choose between two
options:
o Carry out lot change automatically
e see Change lot (applies only to AutoQC measurements) on page B-42
o Do not carry out lot change

Allows you to review or discard your entries.

Exits the QC setup wizard.

Scanning ranges

New QC material
The following screen appears:

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QC setup wizard

Figure B-30

As soon as a valid range is scanned, the corresponding module is marked and the
[Continue] button appears. This allows continuation of the process without having
entered all ranges.

Previously installed QC material

In this case, the system checks whether the ranges have already been assigned. If this
information is missing, the range is scanned, the corresponding module is marked
and the [Continue] button appears.

Changes to existing ranges cannot be made using the QC setup wizard!

Checking for AutoQC compatibility

After all ranges are set, the QC material is checked for AutoQC compatibility.
AutoQC compatible materials:
o AUTO-TROL TS+
o AUTO-TROL PLUS B
The following QC materials do not meet these requirements:
o COMBITROL TS
o COMBITROL TS+
o COMBITROL PLUS
o COMBITROL PLUS B

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QC setup wizard

Figure B-31

If the QC material is not AutoQC-compatible, it will still be installed successfully. In

this case, press the [Exit QC wizard] button to exit the setup wizard.

You can scan more QC materials.

e See Figure B-30 on page B-46!

For AutoQC-compatible materials, the process continues and checks whether an

AutoQC module is installed.

Assigning the mats

The scanned QC material now has to be assigned a position in the AutoQC module.

Figure B-32

All previously assigned mats are displayed. If no position is available, you first have to
delete a position using [Delete].
1 Press [Set]; a material/level combination is assigned to a mat (A-F).
2 Take a full mat out of the package.
3 Tun the mat so that the ampoule necks point down. Turn the mat twice (do not
shake it!).

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QC setup wizard

Ensure that the ampoule necks are free of air bubbles.

Figure B-33

4 Insert the mat into the previously defined position (A-F) of the ampoule block.
5 Close the AQC drawer. The ampoule status is automatically set to 20.

You cannot change the number of ampoules in the QC setup wizard!

AQC timing

If a lot change has been carried out, the AQC times are already defined and are accepted
automatically.

Using this function, depending on the newly installed material/level combination, the
start time(s) for the AutoQC measurement(s) are defined and/or the time is
determined. After the set time is reached, a note appears in the message window.

Figure B-34

All previously defined AQC times are shown in the list.

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QC setup wizard

1 Using the [Mon] - [Sun] buttons, select the day of the week on which the AQC
measurement is to be carried out.
2 Enter starting time and change the number of "Repeats".
3 Press the [Apply QC timing] button. The entries are saved.

If, when entering the start time, there is an overlap with another
QC measurement, a corresponding message is displayed.

Figure B-35

If no day of the week was selected, the QC times cannot be accepted and a
corresponding message is displayed.

Figure B-36

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QC setup wizard

Press this button to exit the QC setup wizard and save the input.

Press this button to save the input and restart the QC setup
wizard.
Press this button to save the input and switch the display to the
section for assigning mats.
e see the section on Assigning the mats on page B-47

Other options for starting the QC setup wizard are:

o Pressing the buttons [Setup] > [QC material] > [QC setup wizard].
Follow the additional instructions on the screen.

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QC measurement

QC measurement

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each exchange
of solutions and packs and after startup of the instrument.
Additionally complete a quality control test on one level between two automatic
2P calibrations. The level have to be alternated (low, normal, high).
e see General QC concept on page B-33

Manual QC measurement

1 Press the following buttons, starting with the top level of the analyzer mode:
h QC measurement

Figure B-37

2 Activate the corresponding QC material and the selected level (for example,
level 1).
3 Remove the ampoule of the corresponding level of the desired QC material from
the packaging or of the AutoQC material from the mat.
4 Gently tap the head of the ampoule with your fingernail to remove any liquid
from the top.
5 Break open the ampoule.

To avoid injury, protect your hands with gloves and tissues when breaking open the ampoule.
Use the control material within 30 seconds of opening.
Never reuse the ampoule.
It is recommended to use an ampoule adapter!

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QC measurement

6 Insert the adapter (see below/A) or the filled capillary (see below/B) into the fill
port.

A Ampoule with adapter B Capillary

Figure B-38 Manual QC measurement

7 Press the [Aspirate sample] button.

8 Detach the ampoule adapter or the capillaries after the message "Remove sample
container" appears.
9 The measurement starts.
10 If the user does not reject the results, they are printed and automatically saved in
the QC database.
e For details about the "Database" see Chapter 9 Software modes, section Data manager
on page B-81 and/or Reference manual, chapter Softwaremodi.

AutoQC measurement

The AutoQC measurement can be performed in programmed or manual mode

([Setup] > [Times & intervals] > [QC timing]).
For this purpose, press [QC measurement] in the analyzer mode, and activate the
corresponding AutoQC material (e.g. AUTO-TROL TS+) and the selected level
(e.g. Level 1).
Start the AutoQC measurement by pressing [Start AutoQC].

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Multirules

Multirules

The evaluation of QC results is based on the Westgard rules(a) and their interpretation
for blood gas analysis(b). The Multirule process was derived from these rules. It
permits early detection of random and systematic errors associated with the
measuring device and its operation.

The Multirules procedure can only be applied in connection with a suitable control material
(e.g. COMBITROL TS+, AUTO-TROL TS+).

The Multirule procedures produce the best results when 3 QC measurements with
randomly selected level are completed per series (time between two 2-point
calibrations). A minimum of 2 QC measurements / series or 6 QC measurements / 3
series is required.
The QC concept expects Multirules rule 1 and 2 to be activated.
Press the following buttons to check the settings:
h Setup > Parameters > Miscellaneous settings > Multirules

Figure B-39

Select additional desired rules in the right part of the window and assign it to the cor-
responding parameter which is listed in the left part of the window under "Parameter".

The activation of range 2SD automatically deactivates all other rules (rules 1-6).

(a) James O. Westgard, et al: A Multi-Rule Shewhart Chart for Quality Control in Clinical Chemistry.
Clinical Chemistry, Vol. 27, No.3, 1981
(b) Elsa F. Quam BS, Lorene K. Haessig BS, Marlene J. Koch BS: A Comprehensive Statistical Quality
Control Program for Blood Gas Analyzers. Journal of Medical Technology 2:1 January 1985

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Multirules

Overview of the Multirules

Serie time between two 2-point calibrations

NT number of individual measurements of all level (T=total)
NL number of individual measurements per level (L=Level)
m QC measurement value of one level and one parameter
x mean value, taken from the insert sheet or calculated based on at least
20 and no more than 100 individual measurements
σ standard deviation

Rule Description
1. 12σ QC measurement value (m) is outside
x ± 2σ
2. 13σ QC measurement value (m) is outside
x ± 3σ
3. (2 von 3)2σ Two of three QC measurement values are outside x ± 2σ
Observation time period: 1 series (within run)
NT = 3
4. 22σ 2 QC measurement values (m) are outside x ± 2σ
Observation time period: 2 series
NL ≥ 2
5. 61σ 6 QC measurement values (m) are outside x ± 1σ
Observation time period: 3 series
NT ≥ 6
6. 9m 9 QC measurement values (m) are on the same side as the mean value
Observation time period: 5 series
NT ≥ 9
2SD range Defined target values (ranges)
Table B-7 Multirules

The Multirule process is applied after each individual measurement.

Multirules are only applied to the corresponding control material (e.g. COMBITROL TS+).

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QC consequences

QC consequences

By default, the QC consequence "QC lock" should be assigned to all parameters.

Press the following buttons to set or check the assigned QC consequences:
h Setup > Parameter > Miscellaneous settings > QC lock

Figure B-40

Description of the QC consequences:

QC-Warning: through a warning, the respective parameter will be

marked in the "Ready" screen, but remains ready for measurement
The measurement protocol now displays "(q)" and "(q) .. QC warning" if
the "QC warning" is activated and the paramter is in the "QC Warning"
status.

QC lock: the parameter will be blocked if one of the adjusted rules is

Figure B-45

5 Here, the respective material/level combinations are listed that can remove this
lock again.
6 Print the list [Print] and perform a manual QC measurement with the listed QC
materials.
e see section Manual QC measurement on page B-51!

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QC troubleshooting

QC troubleshooting

Description of the current problem

After a QC measurement, one or more parameters are assessed as "not OK"

(QC warning or QC block).
The affected parameters and the QC material (material type, level) causing the error
are listed under [Info] > [QC status]. The QC problem can only be solved by a correct
QC measurement within the range if the same material / level combination is
measured.

Classification of QC problems

Group A
The cause is an aspirating or positioning problem with the QC sample. In this case,
usually more than one parameter is affected. A cause in Group A can be recognized in
the data manager under [QC measurements] > [Details], where instead of a result an
error message appears for the respective parameter.

Group B
The cause is a QC result that exceeds the target value range.
A cause in Group B can be recognized in the data manager under
[QC measurements] > [Details], where a result is available but exceeds the target
value range.

Troubleshooting – Group A (aspirating or positioning problem)

1 Check whether all parameters are calibrated.

2 Repeat the QC measurement (with same material / level combination).
3 In event of repeat error:
o If an AutoQC module is in use, a manual QC measurement with the same
material / level combination must be carried out.
o If the manual QC measurement shows the same problem, continue with
Point 4.
o If the manual QC measurement is "OK", the fill port and T&D disk must be
cleaned and the ampoule status under [Info] > [AQC status] must be
compared with the actual availability of the ampoules in the AutoQC module.
o Repeat the QC measurement (with same material / level combination).
o If the error persists, contact customer service.

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QC troubleshooting

4 For the affected measurement chamber, an internal cleaning must be called up

(exception: MSS measurement chamber). Measurement of a blood sample must
then be carried out in order to wet the fluid channels.
5 Repeat the QC measurement (with same material / level combination)
If the error persists, contact customer service.

Troubleshooting – Group B (QC result exceeds the target value range)

1 A system calibration must be carried out for the affected parameters.

o Should parameters of the COOX module be affected, a COOX calibration
must also be carried out.
2 The following points must be checked:
o It must be checked whether the target value ranges under [Setup] > [QC
material] > [QC material] > [select appropriate material] > [Ranges]
correspond to the target value ranges stated in the package insert.
o If an AutoQC module is in use, it must be checked whether the batch number
printed on the AutoQC mat corresponds to that under [Setup] > [QC
material] > [QC material].
o It must be checked whether before use the QC ampoules have been stored for
at least 24 hours at room temperature or in the AutoQC module.
o In event of manual QC measurement, it must be ensured that the time
between opening the ampoules and the QC measurement is kept as short as
possible. Furthermore, it must be ensured that the ampoule adapter is used.
o If an AutoQC module is in use, it must be ensured that the AutoQC
temperature deviates by less than 5 °C from the ambient temperature. Check
under [System] > [Component test] > [Control sensors] > [Temperature
control] > [AutoQC temperature].
3 Repeat the QC measurement (with same material / level combination)
o If the error persists, internal cleaning of the affected measurement chamber
must be carried out (exception: MSS measurement chamber). For this
measurement chamber, a wetting routing must then be called up.
4 Repeat the QC measurement (with same material / level combination)
o If the error persists, the affected electrode / sensor must be replaced. If all
ISE parameters are affected simultaneously, the reference electrode must be
replaced.
If the problem cannot be solved successfully, the Customer Service must be notified.

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Contents

Calibration

In this chapter, all automatic and user-activated calibrations are described.

In this chapter Chapter 8

Calibration - general ..................................................................................................... 51
Automatic calibrations .................................................................................................. 51
System calibration ................................................................................................... 51
2P calibration (2P cal) ............................................................................................. 51
1P calibration (1P cal) incl. O2 ............................................................................... 52
Recalibration - without O2 ...................................................................................... 52
User-activated calibrations ........................................................................................... 52
Display of parameters during calibration .................................................................... 54

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8 Calibration cobas b 221 system
Contents

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cobas b 221 system 8 Calibration
Calibration - general

Calibration - general

The cobas b 221 system uses a technology for simultaneous calibration of PCO2, pH,
Na+, K+, Ca2+ and Cl–, which requires only two aqueous solutions (contained in
S2 Fluid Pack).
Oxygen (O2) is calibrated with ambient air and a zero point solution.
The MSS calibration is carried out with the solutions contained in S3 Fluid Pack
(for instrument versions with MSS module only, cobas b 221<5> system und
cobas b 221<6> system).
The COOX calibration is carried out by entering a tHb calibrator whose exact values
are known (for instrument versions with COOX module only).

Automatic calibrations

The following calibrations are automatically initiated and performed by the analyzer.

System calibration

Every 8, 12 or 24 hours (default) which includes the following:

o Wavelength calibration of polychromator (for instruments with COOX module
only)
o Cleaning with internal cleaning solution
o Automatic conditioning of the Na+ electrode (every 24 hours)
o Calibration of the mixing system
o 2 point calibration of all parameters

The user can set a permanent start time for the system calibration. This enables completion of
calibration tasks while the cobas b 221 system is not in use or when the workload in the laboratory
or station is smaller.

e see Reference manual, chapter Software modes, section Setup.

2P calibration (2P cal)

Adjustable: 4, 8, and 12 hours (standard).

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8 Calibration cobas b 221 system
User-activated calibrations

1P calibration (1P cal) incl. O2

Adjustable: every 30 minutes (standard), 1 hour.

USA: 30 min only!

(adjustable: [Setup] > [Protected setup] - this area is password protected and is accessible only to
authorized personnel or customer service representative!).

Recalibration - without O2

After every measurement.

User-activated calibrations

Activation in analyzer mode:

h System > Calibration

A Example: Instrument with COOX and MSS module

Figure B-46 User-activated calibrations

Performing a "user-activated calibration" does not influence the time lapse of "automatic
calibrations".

Select the parameters to be calibrated. It is not possible to select individual

parameters, instead only functionally coherent groups of parameters can be selected.

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cobas b 221 system 8 Calibration
User-activated calibrations

The following groups can be selected:

o all MSS parameters (for instrument versions with MSS module only
(cobas b 221<5> system and cobas b 221<6> system))
o all ISE parameters, except for Hct
o Hct
o pH and PCO2
o PO2

The following calibrations can be performed:

o Calibration for "Ready":
The system automatically selects a calibration which will transfer all selected
parameters to the state "Ready".
o System calibration
o 1P calibration
o 2P calibration
o Mixing system:
Calibration of the conductivity system
o COOX calibration (for instruments with COOX module only)
e For a detailed description of how to do this, see Chapter 10 Maintenance, COOX
calibration (for instrument versions with COOX module only) on page C-10!
o Polychromator calibration (for instruments with COOX module only):
Wavelength calibration of polychromator
To execute the desired calibration, first press the corresponding selection button.
Activate the calibration by pressing the [Start] button.

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8 Calibration cobas b 221 system
Display of parameters during calibration

Display of parameters during calibration

Figure B-47 System calibration

The already calibrated parameter is also intended for the current

calibration.

The parameter which was not calibrated previously is also intended

for the current calibration.

The parameter is currently being calibrated – chances for a successful

calibration are very high.

The parameter is currently being calibrated – chances for a successful

calibration are very low.

The parameter was successfully calibrated during the current

calibration.

The parameter was not successfully calibrated during the current

calibration.

The parameter was calibrated and is not influenced by the current

calibration.

The parameter was not calibrated and is not intended for the current
calibration.

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B-68 Instructions for Use · Revision 10.0
cobas b 221 system 9 Software modes
Contents

Software modes

In this chapter, all the individual, independent software modes (analyzer, settings,
data manager and info) are described.

In this chapter Chapter 9

Software modes - general .............................................................................................. 71
User interface ................................................................................................................. 71
Parameters ............................................................................................................... 73
Display on the Ready screen (analyzer mode) ................................................. 73
Notation of the measurement, input, and calculation values ......................... 73
Buttons ............................................................................................................... 76
Analyzer mode ............................................................................................................... 78
"Ready" screen ......................................................................................................... 78
System ...................................................................................................................... 79
Quick access ............................................................................................................. 79
QC measurement .................................................................................................... 80
Setup .............................................................................................................................. 80
Data manager ................................................................................................................ 81
General data manager functions ....................................................................... 81
Patients ..................................................................................................................... 83
Measurements .......................................................................................................... 83
Calibrations ............................................................................................................. 84
QC measurements ................................................................................................... 84
Instrument ............................................................................................................... 85
Utilities ..................................................................................................................... 85
Backup / Restore ................................................................................................ 85
Protected DB functions ..................................................................................... 86
Info ................................................................................................................................. 87
Help .......................................................................................................................... 87
Fill level .................................................................................................................... 87
QC status .................................................................................................................. 88

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Contents

Video sequences ....................................................................................................... 88

List of all activities ................................................................................................... 89
List of all warnings .................................................................................................. 90
AQC status ............................................................................................................... 90
Versions .................................................................................................................... 91
Miscellaneous reports ............................................................................................. 91
Parameter report ............................................................................................... 91
Sensor report ..................................................................................................... 92
Status report ...................................................................................................... 92
Protected information ............................................................................................. 92

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cobas b 221 system 9 Software modes
Software modes - general

Software modes - general

During measurement, calibration or other processes, it is possible to conduct

database operations, perform certain settings or call up general information.
The software modes, which may be run independently are defined as follows:

o Analyzer Place sample (measurement), system, QC measurement,

calibration, quick access (which contains commonly used
functions)
o Setup Instrument settings
o Database Data about patients, measurements, calibrations, QC, and
the instrument
o Info

User interface

For example: Top level of the analyzer mode - "Ready"

M M

A L
K

C D E F G H

A Current status of the analyzer mode I Direct call-up of the video sequences
B Status line offered
C AutoQC act. / deact. J Required sample volume (display varies
D Network connection act. / deact. according to activated/deactivated modules)
E Pending maintenance K Software modes (Info, setup, analyzer,
F Type and time of next calibration database)
G Current date L Error / instruction window
H Current time M "active"

Figure B-48 "Ready" screen

For example: "Screen sharing" (a remote monitoring and remote maintenance software is active)

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9 Software modes cobas b 221 system
User interface

A "Screen sharing" (a remote monitoring and

remote maintenance software is active)

Figure B-49

For example: User-defined parameter groups

h Setup > Parameter > User-defined parameter groups
This function helps to define three parameter groups.
e For a detailed description, see the Reference Manual, chapter 3 Setup, section
User defined parameter groups!

Figure B-50

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cobas b 221 system 9 Software modes
User interface

Parameters / icons

Display on the Ready screen (analyzer mode)

Depending on the settings and the status of the instrument, the parameter buttons
may have the following appearance:

Parameter activated and ready

Parameter temporarily deactivated (but calibrated)

Parameter activated with QC warning

Parameter temporarily deactivated with QC warning

Parameter not ready (not calibrated)(a)

Parameter not ready (due to QC lock)(b)

Parameter not ready due to remote lock

Parameter permanently deactivated (under "Setup")

(a) A status report appears after pressing the parameter button.

(b) A status report appears after pressing the parameter button.

Notation of the measurement, input, and calculation values(a)

Measurements (depending on configuration):

PO2 Oxygen partial pressure

PCO2 Carbon dioxide partial pressure
pH Negative decadic logarithm of the hydrogen ion activity
Na+ Sodium ion concentration
+
K Potassium ion concentration
–
Cl Chloride ion concentration
Ca2+ Calcium ion concentration
Hct Hematocrit
tHb Total hemoglobin concentration
O2Hb Oxyhemoglobin
(a) Details and calculation, see Chapter 5 Theoretical foundations

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9 Software modes cobas b 221 system
User interface

HHb Desoxyhemoglobin
COHb Carboxyhemoglobin
MetHb Methemoglobin
Bili Bilirubin (neonatal)
SO2 Functional oxygen saturation
Glu Glucose
Lac Lactate
Urea/BUN Urea
Baro Air pressure

Calculation values:

H+ Hydrogen ion concentration

cHCO3 – Bicarbonate concentration in plasma
ctCO2(P) Total CO2 concentration in plasma
ctCO2(B) Total carbon dioxide concentration in blood
BE Base excess of blood
BEact Base excess of blood at current oxygen saturation
BEecf Base excess of the extracellular fluid
BB Buffer bases
ctO2 Total oxygen concentration
pHst Standard pH value
cHCO3 st – Standard bicarbonate concentration in plasma
PAO2 Alveolar oxygen partial pressure
RI Respiratory index
nCa2+ Standardized ionized calcium (pH = 7.4)
Qs/Qt Shunt—quotient between both oxygen concentration differences
Qt Difference of oxygen concentration between alveolar and mixed venous
blood
P50 Oxygen partial pressure at 50% oxygen saturation calculated with SO2
as measurement value
FO2Hb Fractional oxygen saturation
SO2 Oxygen saturation
SO2(c) Functional oxygen saturation calculated with P50 as input value
AaDO2 Alveolar-arterial oxygen partial pressure
a/AO2 Alveolar-arterial oxygen partial pressure ratio
avDO2 Arterial-venous oxygen level difference
AG Anion Gap
MCHC Middle corpuscular hemoglobin concentration
Osm Osmolality
OER Oxygen extraction ratio

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cobas b 221 system 9 Software modes
User interface

Hct(c) Hct calculated from tHb

P/F Index Ratio PaO2/FIO2
BO2 Oxygen capacity
BUN Urea calculated using Urea

Calculation values at the patient's temperature:

PAO2t Alveolar oxygen partial pressure at patient's temperature

t
RI Respiratory index at patient's temperature
t
AaDO2 Alveolar-arterial oxygen partial pressure at patient's temperature
a/AO2 t Alveolar-arterial oxygen partial pressure ratio at patient's temperature
t
pH pH at patient's temperature
t
PCO2 PCO2 at patient's temperature
PO2 t PO2 at patient's temperature
+t
H Hydrogen concentration at patient's temperature

Input parameters:

R Gas exchange quotient

FIO2 Proportion of inspiratory oxygen
tHb(e) Entered tHb value (not measured)
Hb factor to calculate Hct(c) from tHb values

Additional items:

o Pract. Pat. ID o Admission time o Religion

o Pat. ID o Discharge date o Sex
o Last name o Discharge time o Title
o First name o Date changed o Phone no.
o Middle initial o Time changed o Doctor
o Suffix o Specimen ID o Accepted by:
o Maiden name o Sample container o Clinic info
o Date of birth o Address o Vent. mode
o Temperature o Billing code o VT
o Sample type o Danger code o Srate
o Blood type o Diagnostic code type o PEEP
o Puncture site o Isolation status o PIP
o Operator ID o Marital status o MAP
o Order ID o Age (A/F) o Ti
o Date drawn o Diagnosis o Te

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9 Software modes cobas b 221 system
User interface

o Time drawn o Diet o MV

o Hospital service o Size o Arate
o Ward o Weight o Flowrate
o Department o Insurance code o 24h Urine
o Location o Patient language o ALLEN test
o Admission status o Medication o Remark
o Admission date o Ethnic origin o Samples

Buttons

"Analyzer" active / inactive

"Database" active / inactive

"Setup" active / inactive

"Info" active / inactive

"Aspirate from capillary" resp. "Injection" active

"Aspirate from syringe" active

User logged on / no user logged on

Return to the highest level of the Analyzer mode

Return to the highest level of the Setup mode

Return to the highest level of the Database mode

Return to the highest level of the Info mode

Back one level (used as an enter key to store information or

to return to previous screen)

User stop

Move one entry to the left / right

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User interface

Move left to start / right to end

Move one entry up / down

Move one page down / up

Move to bottom / top

Example for switch button - ON

Example for switch button - OFF

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9 Software modes cobas b 221 system
Analyzer mode

Analyzer mode

The Analyzer mode contains parameter information (e.g. Ready), system settings,
quick access and the QC measurement. The "Ready" screen is the highest level of the
menu tree available.

"Ready" screen

Figure B-51

On this screen, buttons must be pressed to:

o activate / deactivate all available parameters individually
o activate / deactivate a complete module
o start a measurement
o start a QC measurement by pressing the [QC measurement] button
o call up additional menus
The capillary tube shown indicates required sample size depending on parameters
selected.

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cobas b 221 system 9 Software modes
Analyzer mode

System

The following main menus are available:

Figure B-52

e For a detailed description, see the Reference Manual, Chapter Software modes, section
Analyzer > System!

Quick access

Use these functions to start the following actions:

Figure B-53

e For a detailed description, see the Reference Manual, Chapter Software modes, section
Analyzer > Quick access!

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9 Software modes cobas b 221 system
Setup

QC measurement

This function helps start a quality control measurement.

e For more detailed information, see Chapter 7 Quality control.

Setup

Use this function to make the following settings:

Figure B-54

e For a detailed description, see the Reference Manual, chapter Software modes, section
Analyzer > Setup!

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cobas b 221 system 9 Software modes
Data manager

Data manager

Use this function to retrieve the following data:

Figure B-55

e For a detailed description, see the Reference Manual, chapter Softwaremodi, section Data
manager!

General data manager functions

Details - all the available detailed information for the selected dataset is displayed
and can be edited.

Find - the function allows to search for datarecords using defined search criteria.

Sort - this function allows to sort the recordings.

Marker - the current datarecord is permanently marked and now has a yellow
background to make it more easily visible.

Mark range - use this function to mark a range.

Tip: The marking criterion corresponds to the current sort criterion of the datarecords.

Print - the datasets of a marked range or of a marked line are printed out.

Delete - the datasets of the marked range or the marked line are deleted.

"More" - additional available functions are displayed.

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9 Software modes cobas b 221 system
Data manager

Data export to diskette or USB

With this function, the marked data records are exported to a diskette or an USB
storage medium.
If it is a device with an SN > 3000, the marked data records are exported to a
connected USB storage medium. If no USB storage medium is available, the marked
data records are automatically exported to a diskette.
If the USB storage medium is full or write-protected, or if during the read or write
process it is disconnected, the error message "Error exporting data" appears.
Repeated transmission of measuring data
Using this function, marked data records of the measurement database are exported
again via ASTM to a connected LIS/HIS system.

Requirement:
The format must be changed to ASTM!

For calibrations and QC measurements only:

Filter - to set the required filter.

For QC measurements only:

L.-J. graph - use this function to create a Levey-Jennings graph of the selected
datasets from the QC database
QC measurement (Accepted) - using this function the display switches over to the
list of the accepted QC measurements.

QC measurement (Rejected) - using this function, the display switches over to the
list of rejected QC measurements.

For Backup / Restore only:

Copy to disk - the marked archive(s) are copied to a disk.

Backup / Restore
Use this function to perform a data backup.

Figure B-60

e For a detailed description, see the Reference Manual, chapter Software modes, section
Data manager!

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9 Software modes cobas b 221 system
Data manager

Protected DB functions
This area is password-protected and only accessible to authorized personnel or
customer service!

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B-86 Instructions for Use · Revision 10.0
cobas b 221 system 9 Software modes
Info

Info

The following information can be displayed:

Figure B-61

Help

Use this function to retrieve online help information.

Fill level

Figure B-62

This view lists all the data of the solutions, such as lot number, expiration date,
expiration date, start date, the remaining "Time to change" and fill level.

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9 Software modes cobas b 221 system
Info

QC status

Figure B-63

Use this function to determine which material/level combination is blocking a

parameter.
Press the [Print] button to print out the QC Lock Status report.

Video sequences

If this function is not available, contact customer service!

e see Figure B-61 on page B-87!

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cobas b 221 system 9 Software modes
Info

List of all activities

Here, all the activities are listed that have to be carried out (including all the
maintenance added under Setup > Times & intervals > Maintenance schedule).
Press the button [Print] to print out the list.

A Warning window for pending maintenance

Figure B-64

The warning window will always display the oldest message.

e see Figure B-64!
Make sure that the tasks displayed on the screen are executed properly and immediately, as any
additional pending warnings or information can otherwise not be visualized accordingly.

Sensor changing:
The sensors must be replaced without delay as soon as the specified time for sensor replacement has
been reached. MSS sensors must be replaced no later than after 28 days.
Sensors that remain in the instrument after an alarm will suffer decreased performance, which can
result in longer calibration times and deviating measurement values.
The time stated for changing a sensor is a standard value as from the time of insertion of a new
sensor or a new electrode. During operation this value is adjusted to the respective state of the
sensor/electrode and thus becomes more and more exact.

MSS cassette:
The sensors for the parameters glucose, lactate and urea are listed separately in the "List of all
activities", but refer to one sensor; these sensors, however, are not changed separately, but together
with an MSS cassette.

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9 Software modes cobas b 221 system
Info

List of all warnings

Figure B-65

Here, all the module stops and warnings are listed with their code, or it can be found
in Chapter 11 Troubleshooting, using the respective error code (ID)

[Action info] Further information is displayed on the errors indicated.

AQC status

Figure B-66

It shows an overview of the mats and the AutoQC material being used.
Press the [Details] button to display the ampoule status of the selected mat
(blue - full, gray - empty).

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cobas b 221 system 9 Software modes
Info

Versions

Figure B-67

Here, the software versions, the instrument serial number, the MSS cassette label and
the date of insertion of the sensors are listed.
Press the button [Print] to print out the list.

Miscellaneous reports

Parameter report

Figure B-68

Displays the status of the electrodes.

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9 Software modes cobas b 221 system
Info

Sensor report

Figure B-69

Displays the current status of the electrodes / sensors.

Press the [Print] button to print out the sensor report.

Status report
Pressing [Print status report] information about the instrument and a multitude of
settings will be printed.

Protected information

This area is password-protected and only accessible to authorized personnel or

customer service!

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Maintenance C

10 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
cobas b 221 system 10 Maintenance
Contents

Maintenance

In this chapter, all maintenance work is described that is necessary for trouble-free
operation of the instrument.

In this chapter Chapter 10

Maintenance - general ..................................................................................................... 5
Decontamination ............................................................................................................ 5
Input unit ............................................................................................................. 5
Touch Screen ........................................................................................................ 6
Surfaces of the instrument .................................................................................. 6
Tubing paths ........................................................................................................ 6
Recommended disinfectants ............................................................................... 6
Daily ................................................................................................................................. 7
Checking fill level ...................................................................................................... 7
Checking printer paper ............................................................................................. 7
Weekly .............................................................................................................................. 8
Cleaning fill port and sample drip tray .................................................................... 8
Cleaning the touch screen ......................................................................................... 8
Quarterly .......................................................................................................................... 9
Cleaning the T&D disk .............................................................................................. 9
Changing the air filter ............................................................................................. 10
COOX calibration (for instrument versions with COOX module only) ............. 10
Sample-dependent maintenance procedures ............................................................... 13
Exchange of solutions and packs ............................................................................ 13
S1 Rinse Solution / S2 Fluid Pack / S3 Fluid Pack ........................................... 14
Waste water .............................................................................................................. 16
Exchange the waste water container (W Waste Container) ............................ 16
1. Empty the W Waste Container ..................................................................... 17
2. Using the empty S1 rinse solution bottle as W waste container ................. 18
Installing the waste water container ................................................................. 18
Cleaning the modules and tubing paths ................................................................ 19

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10 Maintenance cobas b 221 system
Contents

Module cleaning ................................................................................................ 19

Tubing paths ...................................................................................................... 20
Unscheduled .................................................................................................................. 22
Exchanging the fill port ........................................................................................... 22
Exchanging the peristaltic pump tubes .................................................................. 23
Cleaning the bottle compartment .......................................................................... 25
Replacing printer paper .......................................................................................... 25
With take-up unit (optional) ............................................................................ 27
Replacement of the electrodes ................................................................................ 27
Changing the reference electrode ........................................................................... 30
Changing the MSS cassette
(cobas b 221<5> system and cobas b 221<6> system only) ................................. 32
Cleaning the measuring chambers ......................................................................... 34
Surfaces .................................................................................................................... 35
Changing of AutoQC mats ..................................................................................... 35
Additional maintenance procedures ............................................................................ 38
Yearly service ............................................................................................................ 38
Replacement every three years ................................................................................ 38

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cobas b 221 system 10 Maintenance
Maintenance - general

Maintenance - general

After use, components of the cobas b 221 system, including tubing, waste container, fill port, etc.,
contain biological fluids and therefore represents a possible infectious risk.
Handle these components with care and according to regulations surrounding potentially infectious
materials.
Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if
necessary mouth protectors, must be worn to prevent direct contact with biological working
materials. In addition, a face mask is required if there is a risk. Suitable disinfection and
sterilization procedures must be applied.

Decontamination

The purpose of this procedure is to minimize the risk of infections when replacing
items that were in contact with blood.
Perform these decontamination procedures regularly.
Roche recommends following a decontamination procedure in addition to
regulations specific to the laboratory.

Use only liquid disinfectant such as protein remover (Roche deproteinizer) or an alcohol-based
(about 70%) surface disinfectant.
Do not spray disinfectant directly onto the instrument because this could cause malfunctions in the
electronics.
Do not use any type of bleaching agent. Exception: Roche Deproteinizer

Do not attempt to decontaminate any part of the instrument before shutting it down and
unplugging it from the power source.
Before plugging the instrument back in and turning it on, always wait 15 minutes to allow the
disinfectant to evaporate—Danger of fire and explosion!
For safety reasons, only authorized technical service personnel may decontaminate the power pack!

Regularly decontaminate the following parts of the instrument:

o Input unit consisting of T&D module (incl. fill port) and the sample drip tray
o Touch screen
o Surfaces of the instrument
o Tubing paths

Input unit
e see Cleaning fill port and sample drip tray on page C-8!
e see Quarterly on page C-9!
e see Exchanging the fill port on page C-22!

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10 Maintenance cobas b 221 system
Decontamination

Touch Screen
e see Cleaning the touch screen on page C-8!

Surfaces of the instrument

e see Surfaces on page C-35!

Tubing paths
e see Cleaning the modules and tubing paths on page C-19!

Recommended disinfectants

Do not use any type of bleaching agent. Exception: Roche Deproteinizer

Surfaces 70% alcohol surface decontaminant

Tubing paths Protein remover (Roche deproteinizer)

o Potential dangers
Due to the alkaline and oxidizing character of this preparation, we cannot rule out
local irritation to the skin, eyes, and mucous membranes.
o First Aid measures
O After inhalation: breath fresh air, drink large amounts of water
O After skin contact: wash with generous amounts of water, remove
contaminated clothing
O After eye contact: rinse eyes with generous amounts of water, contact an eye
doctor
O After drinking: drink large amounts of water, avoid vomiting, contact a doctor

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cobas b 221 system 10 Maintenance
Daily

Daily

Checking fill level

Press
h Info > Fill level
to check the fill level of the solutions (S1 rinse solution, S2 Fluid Pack, S3 Fluid Pack)
and the waste container (W Waste Container) on a daily basis.
Exchange empty bottles, bottles whose usage date has expired, and full waste water
bottle.
e see section Exchange of solutions and packs on page C-13 or
section Waste water on page C-16.

Checking printer paper

Check daily to be sure that sufficient paper is available and exchange it, if necessary.

The printer paper is heat sensitive on one side only. Please make sure that you insert the paper roll
correctly!

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10 Maintenance cobas b 221 system
Weekly

Weekly

Cleaning fill port and sample drip tray

Handle these parts with care — danger of injury!

Always wear gloves! Danger of infection!

Activate the following function, starting with the top level of the analyzer mode:
h System > Wash & cleaning > Clean input unit

A T&D cover C Fill port

B T&D disk D Sample drip tray

Figure C-1 Input unit

1 Pull out the sample drip tray and clean it with a cloth moistened with disinfectant.
2 Reinsert the sample drip tray.
3 Clean the fill port with a soft cotton swab moistened with disinfectant.

Cleaning the touch screen

Activate the following function, starting with the top level of the analyzer mode:
h System > Wash & cleaning > Clean screen
The keys on the screen are deactivated for 30 seconds.

Clean only with a moist cloth (for example, one that is soaked with disinfectant).
Do not use water and sprays!

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cobas b 221 system 10 Maintenance
Quarterly

Quarterly

Cleaning the T&D disk

Activate the following function, starting with the top level of the analyzer mode:
h System > Wash & cleaning > Clean input unit
1 Pull out the sample drip tray and clean it with a cloth moistened with disinfectant.
e see Figure C-1 on page C-8

2 Remove the T&D cover.

3 Clean the fill port with a soft cotton swab moistened with disinfectant.
4 Rotate the fill port 90° downward and remove it.

A Needle

Figure C-2 T&D disk

5 Insert the fill port with the flat side into the slot in the T&D disk and turn it 90
degrees to the right or left. Hold the T&D disk in place during this process.
6 Remove the T&D disk.
7 Clean and decontaminate the front and back of the T&D disk.

Do not use alcohol for cleaning the T&D disk.

8 Re-install the disk in reverse order.

9 Re-insert the fill port.
10 Close the T&D cover.
11 Insert the sample drip tray.

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Quarterly

Changing the air filter

1 Pull out the air filter using the box tongue (see below)!

Figure C-3 Air filter

2 Dispose of the air filter according to local regulations (hazardous waste!)

3 Push in the new air filter according to the figure.
e see Figure C-3 on page C-10

The exchange may be performed less frequently in clean lab operations and at room temperature
(significantly below the maximum permissible operating temperature).

COOX calibration (for instrument versions with COOX module only)

This calibration must always be performed following a manipulation of the cuvette, but not later
than every 3 months.

To calibrate the COOX module, enter the tHb calibrator or a blood sample whose
tHb values are exactly known.

To avoid injury, protect your hands with gloves and tissues when breaking open the ampoule.
Never reuse the ampoule and the capillary!

1 Take the ampoule out of the package.

2 Carefully shake the ampoule.
3 Gently tap the head of the ampoule with your fingernail to remove any liquid
from the top.
4 Break open the ampoule. Completely insert the ampoule adapter into the
ampoule or fill the sample into a capillary.
5 Activate the following function, starting with the top level of the analyzer mode:
h System > Calibration > COOX calibration
6 To start the calibration, press [Start].
The following screen appears:

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Quarterly

Figure C-4

7 "tHb (target value) [g/dL]": enter the desired target value using the keyboard.

Take the target value for the tHb calibrator from the label of the tHb calibrator recommended by
Roche Diagnostics.

8 The unit is standard [g/dL] and can be changed, if necessary.

9 "Cuvette replaced" - Press [Yes] after a cuvette was replaced, otherwise press [No].
10 "Sample type". It is possible to select between "tHb calibrator" and "Blood" as
calibration solution.
11 The target value for blood must be a known setpoint.
12 Attach the ampoule adapter (see below/A) or the capillary (see below/B) filled
with tHb calibrator to the fill port (follow the instructions on the screen!).

A Ampoule adapter B Capillary

Figure C-5 Ampoule adapter / Capillary

The COOX calibration is carried out.

After the measurement, the result is displayed. In ideal circumstances, the tHb(i)
value should be identical with the tHb(m) measurement.

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If the cuvette has been replaced, no calibration value appears, just the comment
"COOX calibration performed".
In event of error, repeat the COOX calibration!

This function allows for the introduction of tightened "limits" in your own
estimation. In general, values in the range of +/- 20% of the setpoint can be accepted
in accordance with the adjustability of the module.
If the calibration values are not acceptable, press [Reject]. The module is not
calibrated and transferred to an alarm state.
A recalibration should be performed.
By pressing [Accept], the calibration values are accepted and used for calculating the
layer thickness of the cuvette.
If the calculated thickness layer and the corresponding reference value do not fall
within the specified internal limits, the COOX module is failed and the calibration
needs to be repeated.

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Sample-dependent maintenance procedures

Sample-dependent maintenance procedures

Exchange of solutions and packs

In order to ensure the quality of the measurement results, complete a quality control test on 3 level
(low, normal, high) after each exchange of solutions.

These solutions should be exchanged depending on the rate of measurement and/or

the onboard stability. The screen displays the appropriate information.

A
A

A Rubber sealings B cobas b 221<5> system and

cobas b 221<6> system only

Figure C-6 Solutions and packs

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Sample-dependent maintenance procedures

S1 Rinse Solution / S2 Fluid Pack / S3 Fluid Pack

Depending on the rate of measurement and/or the onboard stability, this fluid packs
should be exchanged every 6 weeks. The screen displays the appropriate information.

The use of an expired fluid pack can lead to calibration errors!

Insert a new pack which has not expired.
Never use expired bottles/packs!

Procedure starting from the analyzer mode:

1 Open the bottle compartment cover.
The following screen appears:

A cobas b 221<5> system and cobas b 221<6> system only

Figure C-7

2 Open the docking mechanism and pull out the bottles/packs to be exchanged.

Dispose of the bottles/packs according to local regulations (hazardous waste!).

Remove packs’ rubber sealings.

3 Insert the new bottle or the new pack in the corresponding position until it stops.
4 The cobas b 221 system recognizes the correct bottle or the correct packs and
verifies the expiration date.
5 If the bottle has passed the expiration date, the screen displays a warning.
6 Close the docking mechanism and the bottle compartment cover. The solutions
are automatically aspirated upwards (detection in the flap).
7 A new QC measurement with all three level (low, normal, high) must be
performed after every exchange of solutions and packs!

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Sample-dependent maintenance procedures

8 Make sure that the results agree with the target values.
e see Chapter 7 Quality control!

To prevent spilling of the S1 rinse solution:

If your facility is 3000 m above sea level or higher deaerate the bottle before inserting
to avoid splashing the S1 rinse solution.
1 Place the bottle tool (see below/A) on the screw cap of the S1 rinse solution (see
below/B).

A Bottle tool B Bottle tool on the screw cap

Figure C-8 Bottle tool

2 Press the grips together and press the transparent disk downward (see below/A).
3 Rotate the transparent disk clockwise and stop when you notice a resistance after a
short distance (see below/B).

A B

Figure C-9 Deaerate bottle S1

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Sample-dependent maintenance procedures

Waste water

Exchange the waste water container (W Waste Container)

1 Open the bottle compartment cover.
The bottle exchange image appears on the display.

Figure C-10

Always wear gloves! Danger of infection!

2 Open the docking mechanism, hold the waste water bottle by the grip recesses and
remove carefully.

Dispose of the waste water container according to local regulations (hazardous waste!).

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Sample-dependent maintenance procedures

1. Empty the W Waste Container

Always wear gloves! Danger of infection!

1 Place the bottle tool on the screw cap.

A Bottle tool B Screw cap with placed bottle tool

Figure C-11 Bottle tool

2 Open the screw cap by pressing the two grips together and rotate them counter-
clockwise.

Figure C-12 Open the screw cap

3 When removing the screw cap, make sure that the green element inside the
container is not moved or removed.

Figure C-13 Screw cap

Empty the waste water and decontaminate the container according to local regulations (hazardous
waste!).
Flush the waste water bottle cap with plenty of water.

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Sample-dependent maintenance procedures

4 Screw the cap back onto the container.

The cap must be screwed shut until completely closed!

Replace waste water container and the screw cap after approx. 5 uses!
Dispose of the waste water container according to applicable local codes and regulations (hazardous
waste!).

2. Using the empty S1 rinse solution bottle as W waste container

o Remove the sticker from the empty bottle of S1 rinse solution.

This sticker may not be reused – discard immediately.

A B C D

A Remove the S1 sticker from the bottle at this B Pull off the sticker beginning from the D "W" sticker on the bottle of S1
location. lower right corner (arrow) until the
sticker "Waste" is completely visible
C "W" sticker

Figure C-14 Sticker

Installing the waste water container

1 Push the bottle to the position for waste water W until it engages.
2 Close the docking mechanism.
3 The fill level monitoring feature recognizes the waste container as "Empty".
If the waste water container to be used is not empty:
Press [Waste fill level] and enter the fill level (a scaling on the container label gives
an approximate value).
4 Close the bottle compartment cover.

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Sample-dependent maintenance procedures

Cleaning the modules and tubing paths

Module cleaning
If required, an internal cleaning procedure is automatically carried out during the 2P
calibration and a system calibration (which similarly includes a 2P calibration)!
The instrument is delivered with the following standard settings for automatic
internal cleaning:

Measuring module Samples Cycle

BG 500 never
ISE 200 never
COOX und tHb/SO2 20 never
MSS --- never
Table C-1

Automatic BG cleaning If the automatic BG cleaning is activated, internal instrument data such as the
measuring frequency and drift behavior of the sensors is used to automatically select
an optimum cleaning interval.
e see Reference Manual chapter 3 Setup, section Times & intervals > Maintenance schedule.

External cleaning An additional external cleaning with deproteinizer should only be carried out if the
measuring chamber is contaminated (protein deposits) or if components of the
sample path must be exchanged.
Activate the following function, starting with the top level of the analyzer mode:
h System > Wash & cleaning > Cleaning modules

Figure C-15

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BG- / ISE-/ COOX- or tHb/SO2 module:

ISE module: the frequency of the cleaning process depends on the lab-specific type of sample
(physiological, pathological, fetal blood).
BG module: should be cleaned only on demand, in the following scenario:
o visible blood clot in the BG module
o low PO2 QC recoveries due to microscopic bacterial contamination of the PO2 electrode

1 Activate the corresponding module and press [Start external cleaning].

2 The external cleaning agent is inserted like a sample (syringe or capillary) via the
fill port.
3 Each external cleaning must be followed by a wetting using whole blood or serum,
press:
h System > Utilities > Fluid actions > Wetting routines
4 Pressing [Start internal cleaning] to carry out a cleaning using the internal
cleaning solution.

MSS module (cobas b 221<5> system and cobas b 221<6> system only):
This cleaning should be performed with every exchange of the cassette, but not more
than once per month (e.g. obstruction).
1 Activate the MSS module and press [Start external cleaning].
2 The external cleaning agent is inserted like a sample (syringe or capillary) via the
fill port.
3 Insert a new MSS cassette using the correct procedure.
e see Changing the MSS cassette (cobas b 221<5> system and cobas b 221<6> system only)
on page C-32!

After the cleaning, perform a polarization of the new MSS cassette.

Tubing paths
Using the function Decontamination all the tubing paths in the instrument can be
decontaminated.

In order to ensure the quality of the measurement results, complete a quality control test on 3 level
(low, normal, high) after the decontamination routine.

h System > Wash & cleaning > Decontamination

This decontamination is carried out in a similar way to the shut down routine, except
that deproteinizer is used instead of distilled water.
The shutdown kit is required for carrying out this function.

The decontamination procedure must be carried out completely and may not be interrupted.
Observe the listed sequence while performing the actions.

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Sample-dependent maintenance procedures

Processing the actions:

Manual The corresponding line of the list box contains an instruction which must be
performed manually. Then press [Confirm action].

Automatic If there is an automatic sequence for any action, you can start this by clicking
[Start process].

If an action has been completed successfully (manually or automatically),

this symbol is displayed.

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Unscheduled

Exchanging the fill port

Dispose of the used fill port in accordance with local regulations (hazardous waste!).

A Needle

Figure C-16

4 Insert new fill port.

Do not bend the needle!

5 Close the T&D cover.

6 Reinsert the sample drip tray.
7 Close the bottle compartment cover.

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Unscheduled

Exchanging the peristaltic pump tubes

A B C
A Main pump C MSS input pump
B MSS output pump

Figure C-17 Peristaltic pump

When changing the peristaltic pump tubes, proceed as follows:

Activate the following function, starting with the top level of the analyzer mode:
h Quick access > Maintenance
1 Select the appropriate pump tube to be changed from the list and press [Perform].
2 Remove the top cover.
3 Open the peristaltic pump's clear plastic cover (tension lever) (see below/A).

A Tension lever
B Pump head
C Linear bracket

Figure C-18 Peristaltic pump

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4 Push the linear bracket (white plastic part) upwards (see below/A).
5 Remove the complete tubing set (tubing holder and tubing) of the corresponding
pump (see below/B).

A Move linear bracket upwards B Remove tubing set

Figure C-19 Peristaltic pump

6 Check if the five rollers are easily moveable.

In case of malfunction contact customer service.
7 Place the tube around the corresponding rolling wheel. Check that the tubing set
is correctly orientated (the grip end must be pointing upwards, see above/B).
8 Close the clear plastic cover (tension lever). The tubing holder is then pressed into
the sealer.
9 Close the top cover.

The tubes may drip a little after being disconnected.

Remove excess fluids with a clean, absorbent cloth.

The peristaltic pump tubes are also replaced during the annual service.

e see section Additional maintenance procedures on page C-38

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Unscheduled

Cleaning the bottle compartment

1 Open the bottle compartment cover.

The bottle exchange image appears on the display.

Figure C-20

2 Open the docking mechanism and pull out all the bottles or packs.
3 Clean the bottle compartment with a cloth moistened with disinfectant
(e.g. disinfectant containing 70% alcohol).
4 Reinsert the bottle or packs.
e see Exchange of solutions and packs on page C-13

5 Close the docking mechanism and the bottle compartment cover.

Replacing printer paper

The printer paper is heat sensitive on one side only. Observe the correct insertion of the thermal
paper roll.

1 Open the printer cover.

2 Open the paper lid.
3 Remove the empty paper roll.
4 Ensure the paper has a clean leading edge to help start the paper through the
rollers. If necessary cut the paper at a right angle.
5 Place the new paper roll into the holder, so that the roll feeds from the bottom.

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6 Ensure that the printer lever is in the "down" position (see below) (only visible
with opened paper cover).

Figure C-21 Printer lever

7 Feed in the beginning of the paper according to the instructions on the inside of
the paper lid (see below).

A
B

A Paper lid B Printer lever

Figure C-22 Place printer paper- without take-up unit

Figure C-23 Place printer paper - with take-up unit (optional)

8 The paper is automatically pulled into the printer.

If the paper is pulled in incorrectly, open the paper cover, open the printer lever
and realign the paper, close the printer lever and close the paper lid again.
9 Close paper lid.

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With take-up unit (optional)

3 Close printer cover.

With an installed take-up unit, the "Automatic Cut" function is deactivated.

Replacement of the electrodes

The electrode must be installed in the instrument no later than the imprinted "Install before" date.
e see section Conventions used in this manual > Other symbols on page 7!
In order to ensure the quality of the measurement results, complete a quality control test on 3 level
(low, normal, high) after each electrode exchange.

1 Remove the top cover and open the measuring chamber cover of the
corresponding measurement module (apply force to push the right edge of the
MC cover to the left with a finger and open up the MC cover).

In each case, open only the relevant measuring chamber.

Keep the bottle compartment cover closed.

The following screen appears:

Figure C-24

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2 Open the locking lever.

3 Take the appropriate electrode, move it to the left and remove it.

Dispose the electrode(s) according to local regulations (hazardous waste!).

4 If necessary, clean the measuring chamber with a cloth moistened with

disinfectant (e.g. disinfectant containing 70% alcohol).

If a new electrode is not available, insert a dummy electrode instead.

SCon and the reference electrode may not be replaced with a dummy electrode.

If an electrode is replaced by a dummy electrode, it must be immediately deactivated permanently

for measurements and calibrations under [Setup] > [Parameters] > [Miscellaneous settings].
To do so, deactivate the switch [Activated for calibrations].

5 Check the internal electrolyte of the electrodes for possible air bubbles
(see below/A).
6 Remove any air bubbles.
Hold the electrode vertically and tap lightly with a fingernail against the electrode
body (see below/B).

A Free of air bubbles! B Remove air bubbles

Figure C-25 Electrode

7 Insert the new electrode according to the color code.

8 Push all electrodes slightly to the right so that they are lined up together without
gaps.
9 Close the locking lever.
10 Scan the barcodes located on the inner packaging of each electrode or enter the
barcodes manually with the help of the keyboard.
11 The replaced electrode is shown slightly lower than the others displayed on the
screen.
12 Read the next actions, their duration and the sensor data.

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Figure C-26

13 Close the measuring chamber and then the top cover.

14 A calibration is performed following a warm-up phase.
15 After completing the calibration, perform a quality control measurement on all
3 level (low, normal, high).
16 Make sure that the results agree with the target values.
e see Chapter 7 Quality control

Changing the reference electrode

The reference electrode must be installed in the instrument no later than the imprinted "Install
before" date.
e see section Conventions used in this manual > Other symbols on page 7!
In order to ensure the quality of the measurement results, complete a quality control test on 3 level
(low, normal, high) after each electrode exchange

Figure C-27 Reference electrode

1 Remove the top cover and open the measuring chamber cover.

In each case, open only the relevant measuring chamber.

Keep the bottle compartment cover closed.

The following screen appears:

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Figure C-28

2 Open the locking lever.

3 Remove the reference electrode.
4 Remove the white connector from the measuring chamber cartridge.
5 Insert the new reference electrode.
6 Attach the white connector at the end of the tube to the measuring chamber
cartridge.
7 Insert the reference tube into the upper tube guide channel of the left locking lever
and into the tube holder of the cover hinge. Close the locking lever.

A Locking lever

Figure C-29 Insert the reference electrode

8 Connect the white connector on the end of the tube to the measuring chamber
cassette (see below).

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Unscheduled

A Connector B Measuring chamber cassette

Figure C-30 Insert the reference electrode 2

9 Scan the barcode of the exchanged reference electrode located on the inner
packaging or enter the barcodes manually with the help of the keyboard.
10 Close the measuring chamber and top cover.
11 A conductivity calibration is performed following a warm-up phase.
12 A new QC measurement with all three level (low, normal, high) must be
performed after every exchange of a reference electrode!
Make sure that the results agree with the target values
e see Chapter 7 Quality control

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Changing the MSS cassette

(cobas b 221<5> system and cobas b 221<6> system only)

The MSS cassette must be installed in the instrument no later than the imprinted "Install before"
date.
e see section Conventions used in this manual > Other symbols on page 7!
Attention:
Replace the MSS cassette within 28 days of installation!
In order to ensure the quality of the measurement results, complete a quality control test on 3 level
(low, normal, high) after each MSS cassette exchange.

Before exchanging the MSS cassette, it is absolutely necessary to prepare a syringe or capillary with
whole blood for polarization.
The blood should have a volume of at least 150 μL, contain heparin as an anticoagulant, and be
stored for less than 24 hours.

Hold the MSS cassette only at the designated handle and avoid touching the contacts.

1 Remove the top cover.

2 Open the cover of the MSS module (apply force to the right edge of the MC cover
with a finger to push it to the left and open up the MC cover).

Keep the bottle compartment cover closed.

The following screen appears:

Figure C-31

3 Open the contact clip and the locking lever.

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4 Push the reference contact (RCon) (see below/B) or the MSS reference electrode
(Ref+ Dummy) (see below/A) and the MSS cassette slightly to the left in the
direction of the arrow and remove the MSS cassette.

A B

A Glu/Lac/Urea C Locking lever

B Glu or Glu/Lac D Contact clip

Figure C-32 MSS measuring chamber

5 Insert the new MSS cassette, and close the locking lever and the contact clip.
6 Read in the barcode from the packaging of the MSS cassette.
7 Close the measuring chamber and top cover.
8 Follow the instructions on the screen. The prepared blood sample is inserted into
the fill port similar to a measurement
e see Chapter 6 Measurement

9 The MSS cassette is subsequently exposed to liquid, polarized, heated and

calibrated.
10 If the automatic polarization was not successful and the MSS parameters are not
calibrated, a manual polarization must be performed.
11 Activate the following function, starting with the top level of the analyzer mode:

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h System > Utilities > MSS polarization

Figure C-33

12 Follow the instructions on the screen.

13 A new QC measurement must be performed with all three level (low, normal,
high) after every exchange of the MSS cassette.
Make sure that the results agree with the target values.
e see Chapter 7 Quality control

Cleaning the measuring chambers

1 Remove the top cover and open the measuring chamber cover.
2 Remove all electrodes.
e see Replacement of the electrodes on page C-27

3 Clean the measuring chamber with a cloth moistened with disinfectant

(e.g. disinfectant containing 70% alcohol).
4 Reinsert the electrodes.
5 Close the measuring chamber cover and top cover.

Do not scan a barcode! Instead, perform the following calibrations:

BG, ISE: calibrating the mixing system, 2P calibration
MSS: system calibration

e see Chapter 8 Calibration, section User-activated calibrations on page B-66

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Unscheduled

Surfaces

Do not attempt to decontaminate any part of the instrument before shutting it down and
unplugging it from the power source.
Before plugging the instrument back in and turning it on, always wait 15 minutes to allow the
disinfectant to evaporate — Danger of fire and explosion!
For safety reasons, only authorized customer service personnel may decontaminate the power pack!

Regularly decontaminate all outer surfaces of the instrument, including all covers
(e.g. printer cover, bottle compartment cover, top cover, T&D cover), with the
disinfectant according to the lab-specific regulations.
Very dirty surfaces should first be cleaned with a swab or paper towel that has been
soaked in distilled water. All removable covers (e.g. instrument cover) can be
removed, sprayed with surface disinfectant and subsequently disinfected using swabs
or cellulose.
Some surfaces require extended soaking to achieve cleaning.

Never spray parts that cannot be removed or that are inside the instrument!

e see section Decontamination on page C-5!

Changing of AutoQC mats

Starting with the top level of the analyzer mode.

1 Pull out the AutoQC drawer.
The following screen appears:

Figure C-34

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2 Remove the empty mat from the ampoule holder.

3 Take a full mat (20 ampoules) from the package.

4 Turn the mat so that the necks of the ampoules face down. Gently wave but do not
shake the mat and ensure that the necks of the ampoules are free of air bubbles.

Figure C-35 AutoQC mat

5 Place the mat in the defined position (A-F) of the ampoule block so that the
ampoules are no longer visible.
6 Press [Refill].
The following question appears:

Figure C-36

7 Press [Yes] – if the mat is replaced with a new one of the same lot. The number of
the ampoules is set to 20.

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Press [No], ], if the new mat was not inserted from the same batch.
In this case the material has to be newly defined.
See Chapter 7 Quality control, section Material setup on page B-36!

8 In case the mats are not completely filled press [Details]. By pressing the
corresponding key the status of the selected ampoule can be changed (see below)
and/or the ampoules to be measured can be selected.
This function can also be used when full ampoules are removed from the mat for
manual measurement.

Figure C-37

9 Close the AutoQC drawer.

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10 Maintenance cobas b 221 system
Additional maintenance procedures

Additional maintenance procedures

The listed maintenance procedures may only be performed by the Technical Support or by Roche
authorized personnel.
The components have been tested during development of the instrument to identify worn parts.
They must be replaced at the annual service to prevent potential malfunctions.

Yearly service

In the course of the yearly service following components have to be replaced:

cobas b 221<1>-<6> system:
o Sample tube
o Fill port
o T&D tubing set
o PP pump head
o PP pump tube
o FMS tubing set
o Waste separator
o Bypass nipple
o Bacteria filter
o T&D disk
o Tubing set tHb/COOX
cobas b 221<2>/<4>/<6> system only:
o Cuvette
o Cuvette seals
o Hemolyzer tube

The tubing paths must also be disinfected annually and the baro value must be checked.

Replacement every three years

In this chapter, all fault messages, their causes and remedies are described. These are
also displayed directly on the instrument screen. All messages are arranged according
to info number.

In this chapter Chapter 11

Troubleshooting - general ............................................................................................... 5
System stops ..................................................................................................................... 5
Module stops ................................................................................................................. 12
System warnings ............................................................................................................ 16
Status messages of measuring and calibration values ................................................. 20
Status messages on the measurement report ............................................................... 39
Barcode .......................................................................................................................... 40

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Instructions for Use · Revision 10.0 D-3
11 Troubleshooting cobas b 221 system
Contents

Roche Diagnostics April 2009

D-4 Instructions for Use · Revision 10.0
cobas b 221 system 11 Troubleshooting
Troubleshooting - general

Troubleshooting - general

After use, components of the cobas b 221 system, including tubing, waste container, fill port, etc.,
contain biological fluids and represent therefore a possible infectious risk.
Handle these components with care and according to regulations surrounding potentially infectious
materials.

Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if
necessary mouth protectors, must be worn to prevent direct contact with biological working
materials. In addition, a face mask is required if there is a risk of splashes. Suitable disinfection and
sterilisation procedures must be applied.

Instructions for Use · Revision 10.0 D-15
11 Troubleshooting cobas b 221 system
System warnings

System warnings

No. Message Cause Action

30005 Cl electrode is Perform the following troubleshooting options
contaminated (defective) step by step until the warning disappears:
1. Press System > Wash & Cleaning > Cleaning
modules > Start internal cleaning.
2. System > Wash & Cleaning > Cleaning
modules > Start external cleaning.
3. Replace Cl electrode
e see Chapter 10 Maintenance, section
Replacement of the electrodes on
page C-27
30008 Pack S2 level is low S2 Fluid Pack will be empty in the next o If necessary, insert a new S2 Fluid Pack.
12 to 24 hours. e see Chapter 10 Maintenance, section
Exchange of solutions and packs on
page C-13
30009 Pack S3 level is low S3 Fluid Pack will be empty in the next o If necessary, insert a new S3 Fluid Pack.
12 to 24 hours. e see Chapter 10 Maintenance, section
Exchange of solutions and packs on
page C-13
30010 Rinse level is low S1 Rinse Solution will be empty in the o If necessary, insert a new S1 Rinse Solution.
next 12 to 24 hours. e see Chapter 10 Maintenance, section
Exchange of solutions and packs on
page C-13
30011 Waste is nearly full The waste bottle will be full in the next o If necessary, replace and/or empty the bottle.
12 to 24 hours e see Chapter 10 Maintenance, section
Waste water on page C-16
Table D-3 System warnings

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D-16 Instructions for Use · Revision 10.0
cobas b 221 system 11 Troubleshooting
System warnings

No. Message Action

30012 Prep. of rinse not ok Perform the following troubleshooting options step by step until the warning disappears:
1. Press System > Component test > Aggregates > Vacuum pump.
If a defect is detected, contact Technical Support.
2. Press System > Utilities > Fluid actions > Fill routines and start Aspirate rinse .
3. Insert a new S1 Rinse Solution.
If this does not remove the warning, contact Technical Support.
30013 Prep. of CAL B not ok Perform the following troubleshooting options step by step until the warning disappears:
1. Press System > Utilities > Fluid actions > Fill routines
and start Aspirate CAL B.
2. Insert a new S2 Fluid Pack.
e see Chapter 10 Maintenance, section Exchange of solutions and packs on page C-13
If this does not remove the warning, contact Technical Support.
30014 Prep. of CAL A not ok Perform the following troubleshooting options step by step until the warning disappears:
1. Press System > Utilities > Fluid actions > Fill routines
and start Aspirate CAL A.
2. Insert a new S2 Fluid Pack.
e see Chapter 10 Maintenance, section Exchange of solutions and packs on page C-13
If this does not remove the warning, contact Technical Support.
30017 Prep. of O2 zero not ok Perform the following troubleshooting options step by step until the warning disappears:
1. Press System > Utilities > Fluid actions > Fill routines
and startAspirate O2 zero point solution.
2. Insert a new S2 Fluid Pack.
e see Chapter 10 Maintenance, section Exchange of solutions and packs on page C-13
If this does not remove the warning, contact Technical Support.
30018 Prep. of Na cond. not ok Perform the following troubleshooting options step by step until the warning disappears:
1. Press System > Utilities > Fluid actions > Fill routines
and start Aspirate Na conditioning solution.
2. Insert a new S2 Fluid Pack.
e see Chapter 10 Maintenance, section Exchange of solutions and packs on page C-13
If this does not remove the warning, contact Technical Support.
30019 Prep. of clean. sol. not ok Perform the following troubleshooting options step by step until the warning disappears:
1. Press System > Utilities > Fluid actions > Fill routines
and start Aspirate cleaning solution.
2. Insert a new S2 Fluid Pack.
e see Chapter 10 Maintenance, section Exchange of solutions and packs on page C-13
If this does not remove the warning, contact Technical Support.
30020 Prep. of standby not ok Perform the following troubleshooting options step by step until the warning disappears:
1. Press System > Utilities > Fluid actions > Fill routines
and startAspirate standby solution.
2. Check MSS sensor for correct fit.
3. Insert a new S3 Fluid Pack.
e see Chapter 10 Maintenance, section Exchange of solutions and packs on page C-13
If this does not remove the warning, contact Technical Support.

1020 Sample distr. error (1) Unable to remove excess sample. o Perform General fluidics test to isolate the
Possible causes: error.

o Clogging or leaky points during System > Diagnostics

12 List of consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

13 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-9
cobas b 221 system 12 List of consumables
Contents

List of consumables

In this chapter, all nessary consumables and order numbers are listed.

In this chapter Chapter 12

Order information .......................................................................................................... 5
Electrodes ................................................................................................................... 5
Solutions .................................................................................................................... 6
QC material ............................................................................................................... 6
Accessories ................................................................................................................. 7

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 E-3
12 List of consumables cobas b 221 system
Contents

Roche Diagnostics April 2009

E-4 Instructions for Use · Revision 10.0
cobas b 221 system 12 List of consumables
Order information

Order information

To measure the respective parameter following products are required:

Electrodes

Parameter
Cl- Na+ K+ Ca2+ PCO2 PO2 pH tHb/SO2 COOX/Bili MSS
Chloride Electrode X + + + + + + + + +
03111571180 (BP1729)
Sodium Electrode + X + + + + + + + +
03111598180 (BP1730)
Potassium Electrode + + X + + + + + + +
03111628180 (BP1731)
Calcium Electrode + + + X + + + + + +
03111644180 (BP1732)
PCO2 Electrode + + + + X + + + + +
03111679180 (BP1733)
PO2 Electrode + + + + + X + + + +
03111695180 (BP1734)
pH Electrode + + + + + + X + + +
03111717180 (BP1735)
Reference Electrode X X X X X X X + + X
03111873180 (BP2081)
Reference Contact (RCon) X X X X X X X + + X
03112071180 (BP2258)
Sensor Contact (SCon) + + + + + + + + + X
03260909184 (BP2608)
Micro Electrode Dummy X X X X X X X X X X
03111849035 (BP1959)
GLU/LAC/UREA Cassette + + + + + + + + + +
03261085184 (BP2500)
GLU/LAC Cassette + + + + + + + + + X
03260887184 (BP2501)
GLU Cassette + + + + + + + + + X
03260895184 (BP2502)
MSS Dummy Sensor + + + + + + + + + +
03351262001
Table E-1

X Has to be installed
+ Dummy or electrode has to be used for proper filling of the measuring chamber

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 E-5
12 List of consumables cobas b 221 system
Order information

Solutions

Paramenter
- + + 2+
Cl Na K Ca PCO2 PO2 pH tHb/SO2 COOX/Bili MSS
S1 Rinse Solution X X X X X X X X X X
03260917184
S2 Fluid Pack X X X X X X X X X X
03260925184
S3 Fluid Pack A X X X X X X X X X X
03260933184
W Waste Container X X X X X X X X X X
03144054001
Hb Calibrator - - - - - - - X X -
03110923035 (BP1360)
Table E-2

X Has to be installed

QC material

Parameter
Cl- Na+ K+ Ca2+ PCO2 PO2 pH tHb/SO2 COOX/Bili MSS
AUTO-TROL PLUS B, Level 1 O O O O O O O O O O
03321169001 (BP9094)
AUTO-TROL PLUS B, Level 2 O O O O O O O O O O
03321177001 (BP9095)
AUTO-TROL PLUS B, Level 3 O O O O O O O O O O
03321185001 (BP9096)
COMBITROL PLUS B, Level 1 O O O O O O O O O O
03321193001 (BP9097)
COMBITROL PLUS B, Level 2 O O O O O O O O O O
03321207001 (BP9098)
COMBITROL PLUS B, Level 3 O O O O O O O O O O
03321215001 (BP9099)
COOX/MSS Verification Material O O O O O O O O O O
03354628001 (BP9403)(a)
TS/MSS Verification Material O O O O O O O O O O
03354601001 (BP9407)(a)
Table E-3
(a) Only for USA available!

O Can be used

Roche Diagnostics April 2009

E-6 Instructions for Use · Revision 10.0
cobas b 221 system 12 List of consumables
Order information

Accessories

Parameter
- + + 2+
Cl Na K Ca PCO2 PO2 pH tHb/SO2 COOX/Bili MSS
Deproteinizer O O O O O O O O O O
03110435180 (BP0521)
Adapter for Capillaries O O O O O O O O O O
03069931001 (BP0959)
Ampoule Adapter O O O O O O O O O O
03066762001 (BP1938)
Clot Catcher O O O O O O O O O O
03112012180 (BP2243)
Cleaning Kit for Cl- Electrode O - - - - - - - - -
03112098035 (BP2276)
Adapters for Sample Container O O O O O O O O O O
03112101180 (BP2277)
Caps for Roche MICROSAMPLER O O O O O O O O O O
03112152180 (BP2288)
Thermo Printer Paper O O O O O O O O O O
03113361180 (HP0107)
Roche MICROSAMPLER, non sterile O O O O O O O O O O
03113434035 (MC0015)
Roche MICROSAMPLER, sterile O O O O O O O O O O
03113442180 (MC0017)
Roche MICROSAMPLER, O O O O O O O O O O
with accessories
03113663160 (US0600)(a)
Roche MICROSAMPLER, O O O O O O O O O O
w/o. accessories
03113671160 (US0601)(b)
Capillary Tubes, ~ 200 μL O O O O O O O O O O
03113477180 (MC0024)
BS2 Blood Sampler (sterile) O O O O O O O O O O
03113493035 (MC0028)
Capillary Tubes, ~ 115 μL O O O O O O O O O O
03113507035(MG0002)
Plastic Capillary Tubes, ~ 140 μL O O O O O O O O O O
05174791001
Sterile Capillary Holder - - - - O O O - - -
05174830001
Caps for Capillary Tubes O O O O O O O O O O
03113647035 (RE0410)
Table E-4
(a) Only for USA available
(b) Only for USA available

O Can be used
- Do not use!

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 E-7
12 List of consumables cobas b 221 system
Order information

Parameter
Cl- Na+ K+ Ca2+ PCO2 PO2 pH tHb/SO2 COOX/Bili MSS
Customer Accessory Kit, O O O O O O O O O O
for cobas b 221<2>/<4>/<6> system
04975626001
Customer Accessory Kit, O O O O O O O O O O
for cobas b 221<1>/<3>/<5> system
04977203001
Tabelle E-5

O Can be used

Roche Diagnostics April 2009

E-8 Instructions for Use · Revision 10.0
cobas b 221 system Glossary
Acid Base Diagram -Dummy electrode

Glossary

docking mechanisms for transporting the fluids into or

A
out of the system.

Acid Base Diagram The log PCO2/pH diagram serves Bottle tool serves for emptying the W Waste Container
as a basis for showing the rearranged Henderson- and for degassing the S1 Rinse Solution.
Hasselbalch equation.
BUN Abbrev. for blood urea nitrogen
Alkaline basic
Bypass nipple Connection between the sample inlet
Analyzer Software mode for measuring, QC path and the transverse channel
measurement, system functions, calibration, quick
access.
C
AQC Abbrev. for AutoQC
Calibration for Ready A calibration is selected to
Arterial blood Blood taken from the artery bring all the activated parameters into the "Ready"
condition.
AutoQC module The AutoQC module is a unit that
automatically takes quality control measurements Clip Plastic fastener on S2 Fluid Pack and S3 Fluid Pack.
programmed by the user.
Clot catcher Coagulum catcher for use with syringes
AUTO-TROL PLUS B AutoQC material for controlling and capillaries
BG, ISE, Glu, Lac, Urea/BUN, COOX/Bilirubin
COMBITROL PLUS B QC material for controlling
AUTO-TROL TS+ AutoQC material for controlling BG, BG, ISE, Glu, Lac, Urea/BUN, COOX/Bilirubin
ISE, Glu, Lac, Hct, tHb/SO2
COMBITROL TS+ QC material for controlling BG,
ISE, Glu, Lac, Hct, tHb/SO2
B
Contact clip The MSS cassette inserted in the
Barcode scanner PS2 hand-held scanner with measuring chamber slit is pressed into position and
integrated decoder for simple input of QC data, electrode thereby firmly positioned.
data, patient or user identity.
COOX module The oximeter module consists of the
BG Abbrev. for blood gas hemolyzer and the COOX measuring chamber. It is an
optical sensor module for determining bilirubin (Bili),
BG measuring chamber The BG measuring chamber total hemoglobin (tHb), and the hemoglobin derivatives
with its sensors serves for measuring the pH value and oxyhemoglobin (O2Hb), desoxyhemoglobin (HHb),
blood gas values PO2 and PCO2 carboxyhemoglobin (COHb) and methemoglobin
(MetHb).
Bilirubin is a yellow decomposition product of the red
blood pigment, hemoglobin, or more exactly, that of the
D
hemoglobin share.

Bottle compartment The bottle compartment Docking mechanism Serves as an interface between
contains the W Waste Container, the S1 Rinse Solution the packs or bottles and the fluid channels in the system
bottle, the S2 Fluid Pack (with the solutions for BG and
ISE) and the S3 Fluid Pack (with the solutions for Glu, Dummy electrode A flow-through electrode without
Lac and Urea/BUN - only cobas b 221<5> system and any measuring function serving as a placeholder.
cobas b 221<6> system).
The bottle compartment also contains the necessary

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 E-9
Glossary cobas b 221 system
Electrodes -NIST standards

E L

Electrodes are flow-through electrodes with a visible Levey-Jennings diagram QC statistical values chart
sample channel.
LF Conductivity
F
Linear bracket White plastic part of the peristaltic
pump.
Filling port Enables a sample to be injected or aspirated
from syringes, Roche MICROSAMPLER, capillaries and
ampule adapters.
M

Fixation lever serves for fixing the sensors in the MC Abbrev. for "measuring chamber"
measuring chamber
Measurement evaluation Before clinical decisions
FMS Fluid mixing system. In combination with the are made on the basis of the results, the plausibility of all
main pump this system guarantees the correct mixture of the measuring results obtained must always be checked
the calibration solutions CAL A and CAL B from the S2 by medical specialists, thereby taking the clinical
Fluid Pack for the next calibrations, with the aid of the situation of the patient into account.
valves VM and V19.
Measuring chamber cassette serves for
transporting the samples and calibration solutions to the
G
waste system after a measurement and/or calibration and
for adding the reference and rinse solution S1.
Glass tube see Sample inlet path (SIP)
Module stop A certain module is not ready for use.
H Nevertheless, the parameters of other modules can still be
measured.

Hematocrit in short, Hct, is the ratio of the volume of MSS Abbrev. for metabolite sensitive sensors
blood cells (mainly the red blood corpuscles) to the total
volume of blood. MSS cassette is a multi-parameter sensor and
contains the spots for measuring Glu, Lac, Urea/Bun
Hemoglobin is the main component of the
erythrocytes and serves for transporting oxygen. MSS measuring chamber The MSS measuring
chamber with its sensors serves for measuring glucose,
Hemolyzer The sample is exposed to a strong lactate and urea/BUN.
ultrasound field whereby the cell membranes of the
erythrocytes are destroyed and the hemoglobin released. MSS polarization serves for wetting and preparing the
MSS cassette.
Heparin salts are the only permissible anticoagulants
Multirules The valuation of the QC results is based on
I the Westgard rules and their interpretation for the blood
gas analysis. The multirule procedure was derived from
this. It enables malfunctions of the instrument to be
Input unit Consists of the T&D module and the sample detected at an early stage.
drip tray.

ISE Abbrev. for ion-selective electrode N

ISE measuring chamber The ISE measuring NIST standards define precise sera with certified
chamber with its sensors serves for measuring the expected values.
hematocrit value and the electrolyte values Na+, K+, Ca2+
and Cl-.

Roche Diagnostics April 2009

E-10 Instructions for Use · Revision 10.0
cobas b 221 system Glossary
Patient Trend Diagram -System warnings

"Ready" screen Main window of the analyzer mode.

P
Reference electrode The reference electrode serves as
Patient Trend Diagram Using this diagram, the a counter electrode of the measuring electrodes. Due to
course of individual parameters (measuring and the reference solution, its signal remains constant,
calculated values) of a patient over an indefinite period of irrespective of the composition of the sample.
time can be shown and printed out.

Peristaltic pump see Pumps!

Plasma Plasma samples are obtained by centrifuging S1 Rinse Solution Wash solution
heparinized whole blood, whereby cellular cell parts of
the blood are separated. S2 Fluid Pack Calibration solutions BG, ISE

Pleural fluid Pleural fluid is a serous fluid produced by S3 Fluid Pack Calibration solutions Glu, Lac, Urea/
the pleurae. BUN

Pleural space The thin space between the two pleural Sample drip tray Prevents dirtying the bottle
layers is known as the pleural space. compartment

Plug monitoring Infrared light barrier for detecting Sample inlet path (SIP) Glass tube. Serves for
plugged or unplugged sample containers. transporting fluids from the T&D disc via the needle to
the sample distribution block (transverse channel).
Polychromator Light is refracted and focused on the
surface of a photosensitive receiver (CCD). Sample throughput Number of samples per hour

PP Abbrev. for peristaltic pump. Sample volume limit is the maximum volume
aspirated from a sample container.
Printer A low-noise thermoprinter with integrated
paper cutter and optional paper winder. SCon Abbrev. for sensor contact. By means of the
conductivity contact, this electrode supports the
Pumps The transport of the sample and the operating monitoring for filling the measuring chambers with fluid.
fluids is effected by means of up to three peristaltic In addition, it measures the temperature in the
pumps, depending on the design (main pump, MSS measuring chamber.
output pump, MSS input pump).
Screen/PC unit Serves as a graphic user interface. All
the information (results, operating instructions, alarms,
Q
warnings, etc.) is displayed on the screen. The screen
consists of a color LCD that is covered with a touch-
QC Abbrev. for quality control sensitive film ("touch screen").

QC material see AUTO-TROL PLUS B, AUTO-TROL SO2 Oxygen saturation

TS+, COMBITROL PLUS B, COMBITROL TS+!
System calibration This is carried out every 8, 12 or
Quality control The known target areas of the QC 24 hours (standard) and consists of wave-length
materials are compared with the QC results of the calibration of the polychromator, internal cleaning,
instrument. automatic conditioning of the Na+ electrode, calibration
of the mixing system and the 2-point calibration of all the
R parameters.

System stop When this error occurs a window is

RCon Abbrev. for reference contact. This is used for the displayed with a red outline; the instrument stops.
Glu/Lac or Glu instrument type and replaces the
reference electrode and dummy electrode. System warnings Warning or indication that does not
require any direct action.

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 E-11
Glossary cobas b 221 system
T&D module -W Waste Container

T&D module The T&D ("Turn and Dock") serves for

sample input, for aspirating solutions from S1, S2, S3 and
the QC material from the AutoQC module. This module
guarantees the fastest possible distribution of the
different fluids.

Tension lever Plexiglass cover on the peristaltic pump

tHb calibrator A calibration solution with known tHb

value for calibrating the COOX module.

tHb/SO2 module An optical measuring module for

determining the total hemoglobin and the oxygen
saturation in the whole blood.

Tonometered whole blood Whole blood is set with

the aid of precision gas to expectancy values to be
calculated for PO2 and PCO2.

Transverse channel serves for optimum

thermostatizing and distribution of samples and
calibration solutions to the measuring modules

Urea Urea (diamide of carbonic acid, Lat. urea pura) is

an organic compound and is produced as an end product
of the metabolism of nitrogen compounds (e.g. amino
acids) produced in the so-called urea cycle and then
excreted in the urin.

Vacuum pump Responsible for washing and drying

the tubing (with the exception of the measuring
chambers).

Valve V19 Air mixing valve

Valve VM Mixing valve for calibration solutions CAL A

and CAL B from S2 Fluid Pack.

W Waste Container Waste container

Roche Diagnostics April 2009

E-12 Instructions for Use · Revision 10.0
Index F

14 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
cobas b 221 system Index

Index

Numerics Calibration procedure, A-13

Calibrations
1P calibration (1P cal) incl. O2, B-66
– Automatic calibrations
2P calibration (2P cal), B-65
– 2P calibration (2P cal), B-65
Capillary measurement, B-21
A Capillary tubes, B-7
Change lot (applies only to AutoQC measurements),
Abbreviations, 8
B-42
Accessories, A-28
Changing of AutoQC mats, C-35
Acid base map, B-28
Changing the air filter, C-10
Air filter
Changing the MSS cassette, C-32
– Changing the air filter, C-10
Changing the reference electrode, C-29
Analyzer mode, B-78
Checking fill levels, C-7
– Data manager, B-81
Checking printer paper, C-7
– QC measurement, B-80
Chloride, A-114
– Quick access, B-79
Cleaning fill port and sample drip tray, C-8
– Ready screen, B-78
Cleaning the bottle compartment, C-25
– Setup, B-80
Cleaning the measuring chambers, C-34
– System, B-79
Cleaning the modules and sample paths
Application area, A-11
– Module cleaning, C-19
AQC status, B-90
Cleaning the modules and tubing paths, C-19
Aspirate from syringe, B-21
– Tubing paths, C-20
Auflistung - Verbrauchsmaterialien, E-3
Cleaning the T&D disk, C-9
Automatic calibrations, B-65
Cleaning the touch screen, C-8
– 1P calibration (1P cal) incl. O2, B-66
Clinical significance, A-109, A-114
– 2P calibration (2P cal), B-65
– PO2, A-110
– Recalibration - without O2, B-66
– Glucose, A-124
– System calibration, B-65
– Hematokrit, A-117
AutoQC
– Hemoglobin derivatives and bilirubin, A-120
– Specifications, A-92
– Carboxyhemoglobin (COHb), A-121
AutoQC materials - Material assignment, B-38
– Methemoglobin (MetHb), A-122
AutoQC measurement, B-52
– Oxyhemoglobin (O2Hb), A-121
– Total bilirubin, A-123
B – Ionized calcium, A-115
– Lactate, A-125
Barcode, D-40
– Oxygen saturation, A-119
Barcode scanner, A-23, A-31
– PCO2, A-110
– Specifications, A-94
– pH, A-109
Bottle compartment, A-20
– Potassium, A-112
Brands, 2
– Sodium, A-111
Buttons, B-76
– tHb (total hemoglobin concentration), A-118
– Urea/BUN, A-126
C Contact addresses, 2
Conversion table for units, A-97
Cal. intervals & timing, A-33
COOX calibration (for instrument versions with COOX
Calibration, A-88, B-63, B-65
module only), C-10
– 1P calibration (1P cal) incl. O2, B-66
COOX module, A-20
– Automatic calibrations, B-65
Copyright, 1
– Display of parameters during calibration, B-68
Correlation to other methods, A-82
– Recalibration - without O2, B-66
– System calibration, B-65
– User-activated calibrations, B-66

Roche Diagnostics April 2009

Instructions for Use · Revision 10.0 F-3
Index cobas b 221 system

V
Versions, B-91
Video sequences, B-88

W
Warning and identification labels (incl. nameplate),
A-24
Waste water, C-16
– Exchange the waste water container (W Waste
Container), C-16

Roche Diagnostics April 2009

F-8 Instructions for Use · Revision 10.0

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