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Manual Roche Cobas B 221

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0% found this document useful (0 votes)

634 views360 pages

Manual Roche Cobas B 221

Uploaded by

Manuel Alejandro Navarro Salgado

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

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cobas b 221 system

Instructions for Use

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

Roche Diagnostics GmbH

Sandhofer Strasse 116
D-68305 Mannheim
Germany
www.roche.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
11.0 >7.06 February 2011
12.0 >7.08 May 2012
13.0 >7.09 October 2012
14.0 >8.0 February 2014
Table 1 Revision history

Edition notice

cobas b 221 system

In the course of 2006 the Roche OMNI S system was relaunched under the
Roche 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.

Roche Diagnostics February 2014

Instructions for Use · Version 14.0 3
cobas b 221 system

© 2003-2014, Roche Diagnostics International Ltd. 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. While every effort is
made to ensure its correctness, Roche assumes no responsibility for errors or
omissions which may appear in this document. Subject to change without notice.

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

Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
www.roche.com

Edition

Revision 14.0, February 2014

First edition: May 2003

Roche Diagnostics February 2014

4 Instructions for Use · Version 14.0
cobas b 221 system

Table of contents

Revision History 3 Operation

Edition notice 3
Copyright 4
6 Measurement
Brands 4
Preanalytics 145
Contact addresses 4
Interferences 151
Edition 4
Limitations of clinical analysis 157
Table of contents 5
Measuring procedure 160
Preface 7
Aspirate from syringe 163
How to use this manual 7
Use as default setup 165
Where to find information 7
Data input 166
Conventions used in this manual 7
POC mode (Point-of-care mode) 171

Introduction and specifications 7 Quality control

Quality control - general 175
General QC concept 176
1 Safety information
Important information concerning the
Important information 19
analysis of QC measurement results 178
Operating safety information 20
Material setup 179
IT Security Advisory 21
Material assignment – AutoQC materials 181
QC timing 184
2 General descriptions
Setting start time(s) 185
Introduction 25
Change lot (applies only to AutoQC
General notes 27
measurements) 186
Measurement and calibration procedure 29
Control - on board time 188
Measurement evaluation 31
Scanning the material code 190
Safety instructions for specific dangers 32
Scanning ranges 191
Handling solutions 33
Checking for AutoQC compatibility 192
Handling electrodes 34
QC measurement 196
General notes on the use of the MSS cassette 35
AutoQC measurement 198
System description 37
Multirules 199
Overview of the Multirules 200
3 Installation and shutdown
QC consequences 201
Installation 45
Remove the QC lock 202
Shutdown 65
Exchange the electrode 203
QC for Ready (with AutoQC module) 204
4 Specifications
QC for Ready (without AutoQC module) 206
Performance data 79
QC troubleshooting 208
Sample throughput 103
Measurement times of the samples 104
8 Calibration
Sample volumes 105
Calibration - general 213
Sample types 106
Automatic calibrations 213
Calibrations 107
User-activated calibrations 214
Environmental parameters 108
Display of parameters during calibration 216
Product data 111
AutoQC 112
9 Software modes
Printer 112
Software modes - general 219
Touch screen-PC unit 113
User interface 219
Barcode scanner 114
Parameters/icons 221
Analyzer mode 226
5 Theoretical foundations
Setup 228
Parameters and calculations 117
Data manager 229
Reference and critical values 132
Info 235

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Instructions for Use · Version 14.0 5
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Maintenance

10 Maintenance
Maintenance - general 247
Decontamination 247
Daily 249
Weekly 250
Quarterly 252
Sample-dependent maintenance procedures 256
Unscheduled 265
Additional maintenance procedures 286

Troubleshooting

11 Troubleshooting
Troubleshooting - general 293
System stops 294
Module stops 300
System warnings 304
Status messages of measuring and calibration
values 308
Status messages on the measurement report 324
Barcode 325

Appendix

12 List of consumables
Order information 331

13 Glossary

Index
Index 341

Revisions

13 Revisions
Revision 351

Roche February 2014

6 Instructions for Use · Version 14.0
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

Q o Keep this manual in a safe place to ensure that it is not damaged and remains available
for use.
o This Instruction 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 Instruction 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

Table 2 Symbols

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Instructions for Use · Version 14.0 7
cobas b 221 system

Symbol Used for

Attention
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.
Warning
Sections marked with this symbol 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.
ESD protective measures
All sections/text passages that are marked with this symbol refer to
components that require special care with respect to electrostatic discharges.
Packaging with this label may be opened by trained personnel only.
Table 2 Symbols

IVD symbols The symbols are used in accordance with DIN EN 980(1) and DIN EN ISO 780(2).

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

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

Table 3 IVD symbols

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

Roche February 2014

8 Instructions for Use · Version 14.0
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Symbol Description
Biological risk
(according to the standard IEC/EN 61010-2-101)(1)(Instrument)

Biological risk
(according to the standard DIN EN ISO 980)(2)(Consumables)

Do not use if package is damaged

Do not reuse

Fragile. Handle with care

Handle with care

Valid only for Roche MICROSAMPLER PROTECT:

Method of sterilization using ethylene oxide

Valid only for BS2 Blood Sampler:

Method of sterilization using irradiation

Table 3 IVD symbols

(1) 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).
(2) DIN EN ISO 980: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied (Part 1: General requirements).

Roche February 2014

Instructions for Use · Version 14.0 9
cobas b 221 system

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 electrode.
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.
Danger symbol: "Corrosion" (on the label and the packaging of
S2 Fluid Pack)
Hazard statement: Causes severe skin burns and eye damage.
Prevention: Avoid contact with eyes and skin, do not swallow
or inhale vapor. Wear protective, gloves, clothing, eye and face
protection.
Warning symbol: "Exclamation mark" (on the label and the
packaging of S2 Fluid Pack)
Hazard statement: Harmful if swallowed.
Prevention: Wash thoroughly after handling. Do not eat, drink
or smoke when using this product..
Invisible Laser Radiation
Avoid direct radiation to eyes.
Laser Class 3R according to EN 60825-1
P0  5 mW
 = 635 - 850 nm

Store upright

"Grüner Punkt" (in Germany)

Protective gloves, protective goggles and suitable protective

1 Safety information ........................................................................................................................... 17

2 General descriptions......................................................................................................................... 23
3 Installation and shutdown............................................................................................................... 43
4 Specifications .................................................................................................................................... 75
5 Theoretical foundations ................................................................................................................. 115

February 2014
cobas b 221 system 1 Safety information
Table of contents

Safety information 1

The information provided in this chapter is essential for the safe, trouble-free
operation of the instrument and must be read and understood by the user.

In this chapter Chapter 1

Important information ........................................................................................................19
Operating safety information .............................................................................................20
IT Security Advisory............................................................................................................21
Description......................................................................................................................21
Security precautions.......................................................................................................21

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Table of contents

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18 Instructions for Use · Version 14.0
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Important information

Important information

These Instructions for Use contain vital warnings and safety information.
This instrument is intended to be used only for the specialized purpose described in
the instructions. The most important prerequisites for use, operation, and safety are
explained to ensure smooth operation. No warranty or liability claims will be covered
if the machine is used in ways other than those described or if the necessary
prerequisites and safety measures are not observed.
The instrument may be operated only by persons whose qualifications enable them to
comply with the safety measures that are necessary during operation of the
instrument.
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 (1 = low, 2 = normal, 3 = high) after each electrode exchange, after
each exchange of solutions and packs and after startup of the instrument (switched
off more than 24 hours).
Additionally complete a quality control test on one level between two automatic 2P
calibrations. The levels have to be alternated (1 = low, 2 = normal, 3 = 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)

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

Roche February 2014

Instructions for Use · Version 14.0 19
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(1)
o IEC/EN 61010-2-101(2)
o IEC/EN 61010-2-081(3)
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 according to IEC /EN 61010-1, 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)(4).
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.
Warning
r The power cord must be plugged into a grounded power receptacle. When using an
WARNING extension cord, make sure it is properly grounded.
r 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.
r 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.
r The use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.

(1) IEC/EN 61010-1: Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 1: General requirements)
(2) 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)
(3) IEC/EN 61010-2-081: Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes)
(4) are no longer manufactured or offered.

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20 Instructions for Use · Version 14.0
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IT Security Advisory

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(1) BG, pH, tHb/SO2

o cobas b 221<2> system BG, pH, COOX, Bili
o cobas b 221<3> system (1) BG, pH, ISE, Hct, tHb/SO2
o cobas b 221<4> system BG, pH, ISE, Hct, COOX, Bili
o cobas b 221<5> system(1) BG, pH, ISE, Hct, MSS, tHb/SO2
o cobas b 221<6> system BG, pH, ISE, Hct, MSS, COOX, Bili
(1) are no longer manufactured or offered.

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.
U For details see Software modes (p. 217)
The individual, mutually independent software modes are defined as follows:
Roche February 2014
Instructions for Use · Version 14.0 25
2 General descriptions cobas b 221 system
Introduction

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

Roche February 2014

26 Instructions for Use · Version 14.0
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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.
U For additional information, see Installation and shutdown (p. 43), section Installation
(p. 45) and Shutdown (p. 65).

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 (1 = low, 2 = normal, 3 = high) after each electrode exchange, after
each exchange of solutions and packs and after startup of the instrument (switched
off more than 24 hours).
Additionally complete a quality control test on one level between two automatic
2P calibrations. The levels have to be alternated (1 = low, 2 = normal, 3 = high).
U For additional information, see Quality control (p. 173).
With Software V 6.0 onwards, using cobas bge link software, the instrument can be
monitored from one location, any disturbances can be remedied and the analytical
quality monitored.
cobas bge link software is a remote monitoring and remote maintenance software for
Roche Point-of-Care analyzers.
U see Figure 2-2 (p. 28)

Roche February 2014

Instructions for Use · Version 14.0 27
2 General descriptions cobas b 221 system
General notes

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

Figure 2-2

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.

Caution
r As long as the "screen sharing" symbol is displayed in the status line, the service
CAUTION 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

Table 2-1

U For additional information, see section Buttons (p. 224).

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28 Instructions for Use · Version 14.0
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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+- and 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.

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2 General descriptions cobas b 221 system
Measurement and calibration procedure

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

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30 Instructions for Use · Version 14.0
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Measurement evaluation

Measurement evaluation

Warning
r The measurement results that are output by the cobas b 221 system must always be
WARNING checked for plausibility by medical specialists with consideration of the clinical
situation of the patient before a clinical decision is made based on the results.

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (1 = low, 2 = normal, 3 = high) after each electrode exchange, after
each exchange of solutions and packs and after startup of the instrument (switched
off more than 24 hours).
Additionally complete a quality control test on one level between two automatic
2P calibrations. The levels have to be alternated (1 = low, 2 = normal, 3 = high).
U For detailed information, see Quality control (p. 173).

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Safety instructions for specific dangers

Safety instructions for specific dangers

Handling samples

While handling samples, all necessary regulations concerning hygiene must be

observed. Dangerous pathogenic agents could be present.
U For more detailed information, see Measurement (p. 143)

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

Q Dispose of waste water, bottles, packs, electrodes and the instrument according to local
and/or laboratory 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

U For more detailed information about decontamination, see Maintenance (p. 245)

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32 Instructions for Use · Version 14.0
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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.

Warning: DO NOT FREEZE

r If frozen, the solution's concentration may change and cause calibration errors.
WARNING r Do not use damaged fluid packs (S2 and S3). Do not mix the individual components.

U For "Storage specifications", see Specifications (p. 75).

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2 General descriptions cobas b 221 system
Handling electrodes

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.

U For "Storage specifications", see Specifications (p. 75).

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34 Instructions for Use · Version 14.0
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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

Instructions for Use · Version 14.0 37
2 General descriptions cobas b 221 system
System description

Caution
r As sharp objects can damage the touch-sensitive film, only touch the film using
CAUTION 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.

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

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 2-4 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.

COOX module

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

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38 Instructions for Use · Version 14.0
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System description

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).

Reverse side

A D

A Power supply D Air filter

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

Figure 2-5 Reverse side

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2 General descriptions cobas b 221 system
System description

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 2-6 Power supply

Interfaces

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 2-7 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 2-8 Interfaces (with USB)

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40 Instructions for Use · Version 14.0
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System description

o Variant 2:
2x RS 232 interfaces (COM 1 and COM 2) (SN < 1500)
U see Figure 2-7 Interfaces (without USB) (p. 40)
o Variant 1:
1x RS 232 interface (COM 1) and 1x USB (SN > 1500)
U see Figure 2-8 Interfaces (with USB) (p. 40)
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)
Caution
r No reverse compatibility from Variant 2 to Variant 1 possible.
CAUTION

Barcode scanner

Figure 2-9 Barcode scanner

Q Not shown in Figure 3-1 Accessories (p. 46):

o 1 screen/PC unit
o 1 power supply
o 1 fill port

Figure 3-1 Accessories

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Procedure

P 1. Screen/PC unit
Caution
r Ensure that the printed serial number on the rear of the screen/PC unit is the same as
CAUTION 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 3-2 Swivel arm of the Screen/PC unit

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

P 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 3-3 Power supply

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2 Tighten the screw.

P 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.
S

P 4. Switch on
1 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.
S

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

Q 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]

2 Processing the actions manually

Manual:
The corresponding line of the list box contains an instruction which must be
performed manually. Then press [Confirm action].
3 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.

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

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

2 Select the language.

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P 7. Change the keyboard layout language (optional)

Q Changing the keyboard layout language requires a software (SW) restart.

1 Choose the following buttons:

h Setup > Instrument > Select keyboard layout
2 Choose the desired keyboard layout language.
3 Choose the Yes button.
4 Wait for the SW restart procedure to complete.
S

P 8. Set the date and time

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

Figure 3-4 Act. time/date

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P 9. Cal. intervals & timing

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

Figure 3-5 Cal. intervals

Use this function to enter the automatic calibration times and intervals for
system, 1P and 2P 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).

P 10. Set valves for FMS tubing exchange

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

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

P 11. Fix screws at V19 (bottle compartment)

1 Open the bottle compartment cover and the docking mechanism "S3".
2 Tighten the screws on valve V19 (approximately 2-3 rotations).
U see Figure 3-6 Valve V19 and VM (p. 51)

Q Use the delivered screwdriver.

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A A

A Screws on valve V19 B

Figure 3-6 Valve V19 and VM

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

P 12. 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 3-7 Valve VM

Figure 3-8 Valve VM

3 Close docking mechanism and bottle compartment cover.

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P 13. 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.

Warning
r Do not bend the insert needle during this process.
WARNING

A Needle

Figure 3-9 Insert needle

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

Figure 3-10

6 Open the T&D lock.

U see Figure 3-11 Glass tube (p. 53), A
7 Insert the glass tube into the guides, fasten it and check it for a correct position.
U see Figure 3-11 Glass tube (p. 53), C
U see Figure 3-11 Glass tube (p. 53), D

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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 3-11 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 3-12 T&D lock

9 Close the T&D cover.

10 Insert the sample drip tray.
S

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P 14. Insert printer paper

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

1 Open the printer cover and the paper lid.

A Printer cover B Paper lid

Figure 3-13 Printer

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 3-14 Printer lever

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 3-15 Insert printer paper - without take-up unit

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Figure 3-16 Insert printer paper - with take-up unit (optional)

6 The paper is automatically pulled into the printer.

7 Close paper lid.
S

P 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.
U see Figure 3-16 Insert printer paper - with take-up unit (optional) (p. 55)

Q 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.

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

P 15. 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 3-17 Peristaltic pump

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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 3-18 Peristaltic pump

AutoQC module (option)

Q The installation with an AutoQC module (optional) must be performed by a Roche

Service Representative.

P 16. Go to AutoQC service position

1 Press [Start process]. This action is performed automatically.
S

P 17. 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 B

Figure 3-19 AutoQC valve clamp

3 Close the AutoQC drawer.

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P 18. Go to AutoQC home position

1 Press [Start process]. This action is performed automatically.
S

P 19. Open AutoQC drawer and insert ampoule holder

1 Pull the AutoQC drawer out again.

A without ampoule holder B with ampoule holder

Figure 3-20 AutoQC drawer

2 Insert the AutoQC ampoule holder.

3 Close the AutoQC drawer.
S

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

A
A

A Rubber seals B cobas b 221<5> system and

cobas b 221<6> system only

Figure 3-21 Waste container & packs

2 Open the corresponding docking mechanism.

3 Insert an empty waste water bottle and a S1 Rinse Solution bottle.

Caution
r Remove packs’ rubber seals.
CAUTION

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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 3-22 Changing of bottles and packs

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

Figure 3-23 Bottle compartment

5 Close the docking mechanism and the bottle compartment cover.

Q 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 3-24 Screw cap

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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).

Figure 3-25 Open bottle

P 21. Open the measuring chamber cover and insert the sensors
1 BG/ISE measuring chamber
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).

Q In each case, open only the relevant measuring chamber.

Keep the bottle compartment cover closed.

The following screen appears:

Figure 3-26 Changing of electrodes

2 Open the locking lever.

U see Figure 3-29 Insertion of the reference electrode (p. 61)
3 Follow the instructions on the screen.

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

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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 3-27 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.
S

P Insert the reference electrode

Warning
r The reference electrode must be installed in the instrument no later than the imprinted
WARNING "Install before" date. The reference electrode must be replaced after 52 weeks of in-use
time. Therefore, set up an alert in the Maintenance schedule:
U see Setting up the Maintenance schedule (p. 272)

1 Insert the reference electrode.

Figure 3-28 Reference electrode

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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 3-29 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 3-30 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.
S

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

Q 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).

Q Keep the bottle compartment cover closed.

2 Open the contact clip and the locking lever.

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3 Depending on the MSS parameter configuration, insert the MSS reference

electrode (Ref + dummy) (see Figure 3-31 MSS measuring chamber (p. 62)/A) or
the reference contact (RCon) (see Figure 3-31 MSS measuring chamber (p. 62)/B)
and the MSS cassette, close the contact clip and the locking lever.

A B

A Ref + dummy (for Glu/Lac/Urea) C Contact clip

B Locking lever D RCon (Glu or Glu/Lac)

Figure 3-31 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.

P 22. Complete installation

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

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

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P 23. 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 3-32 MSS polarization

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

U see Measurement (p. 143)
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.
S

P 24. Checking the barometer value

1 h System > Component test > Control sensors > Baro sensor
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.

Caution
r A wrong barometer value leads to wrong PO2 measurement results.
CAUTION Important:
r From approximately 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 permanently deactivated.

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2 To deactivate the parameter PO2 press the following buttons:

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

P 25. Quality control

1 Define the material and if an AutoQC drawer (option) is available insert the mats
before performing a quality control measurement.
U For details, see Quality control (p. 173)
2 Perform quality control tests for all 3 levels (low, normal, high). Make sure that
the results are in line with the target values.
U See Quality control (p. 173)
S

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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.

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

U See section 21. Open the measuring chamber cover and insert the sensors (p. 59).

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 recommends decontaminating all surfaces and tube
paths.

U see section Decontamination (p. 247).

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

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

Q 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].

Upon successful completion, this symbol is displayed.

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Shutdown

P 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).

Warning
r Do not remove the waste container.
WARNING
2 Close docking mechanism and bottle compartment cover.
S

P 2. Fill the shutdown kit with distilled water

1 Fill the shutdown kit about halfway with distilled water.

Figure 3-33 Shutdown kit

P 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".
S

P 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".
S

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P 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".
S

P 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".
S

P 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.
S

P 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.
S

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P 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 3-34 Peristaltic pump

2 Push the linear bracket (white plastic part) upwards (see below/A).
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 3-35 Peristaltic pump

4 Close the tension lever.

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P 10. Remove the printer paper

1 Open the printer cover and the paper lid.

A Printer cover B Paper lid

Figure 3-36 Printer cover/paper lid

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

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

Figure 3-37 Printer lever

3 Remove the printer paper.

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

P 11. Open T&D

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

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

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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 3-38 T&D lock & sample inlet path

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

Q Do not bend the needle.

B
A

A Fill port B Needle

Figure 3-39 Fill port

5 Close the T&D lock again.

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6 Close the T&D cover.

P 13. Set valves for FMS tubing exchange

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

Q Both valves are pushed out.

P 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 (approximately 2-3
turns).
A A

V 19

A Screws

Figure 3-40 Valve V19

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

P 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.

A VM B Tube clip

Figure 3-41 Valve VM

3 Pressure is removed from the tubes.

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4 Close the docking mechanism and the bottle compartment cover.

If available (option):
S

P 16. Go to AutoQC home position

1 Press [Start process]. This action is performed automatically.
S

P 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.
S

P 18. Go to AutoQC service position

1 Press [Start process]. This action is performed automatically.
S

P 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).

A AutoQC valve clamp

Figure 3-42 AutoQC valve clamp

3 Close the AutoQC drawer.

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Performance data

Performance data

Measurement parameters

Parameter specified for specified range

PO2 (1) 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%
Glucose (2) (cobas b 221<5> system, 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) (1) 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)(1) B/Q 0 – 100%

COHb (COOX)(1) B/Q 0 – 100%

O2Hb (COOX)(1) B/Q 0 – 100%

MetHb (COOX)(1) B/Q 0 – 100%

Bilirubin (neonatal) (COOX) B/Q 3 - 50 mg/dL 51.3 - 855 μmol/L
Baro 450 - 800 mmHg
Table 4-1 Measurement parameters
(1) Limit of Quantitation (LoQ) values: PO2: 1.15 mmHg, Urea: 0.537 mmol/L, HHb: 1.26%, COHb: 1.37%, O2Hb: 36.6% and MetHb: 0.691%. If the
measured value is lower than the value stated here, then the parameter is flagged with a #.
(2) 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(1)
A Dialysis solutions containing acetate
D Dialysis solutions containing bicarbonate
S Serum or plasma
PF Pleural fluid (can be measured in serum/plasma mode)

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Performance data

(1) with approximate physiological ion matrix and buffer capacity

Precision

"Repeatability (Swr)" and "Intermediate precision (ST)" was determined from 2 runs
per day with 2 replicates per run for 20 days on four cobas b 221 systems.
The mean value is the measured value of the corresponding parameter for which Swr
and ST are representative resp. have been determined.

Parameter Unit
pH pH units
PCO2 mmHg
PO2 mmHg
Sodium mmol/L
Potassium mmol/L
Chloride mmol/L
ionized Calcium mmol/L
Hct %
Lactate (cobas b 221<5> system, mmol/L
cobas b 221<6> system only)
Glucose (cobas b 221<5> system, mmol/L
cobas b 221<6> system only)
Urea (cobas b 221<6> system only) mmol/L
tHb (tHb module) g/dL
SO2 (tHb module) %
tHb (COOX) g/dL
SO2 (COOX) %
O2Hb %
COHb %
MetHb %
HHb %
Bilirubin (neonatal) mg/dL
Table 4-2

Material: acetat - standard solution (Level 1), NIST Traceable, n=80

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

Sodium 140.0 0.5600 0.40 0.7405 0.53
Potassium 2.02 0.0165 0.82 0.0290 1.44
Chloride - - - - -
ionized Calcium 1.622 0.0155 0.96 0.0205 1.26
Table 4-3 Acetat - standard solution (Level 1), NIST Traceable, n=80

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Performance data

Material: acetat - standard solution (Level 2), NIST Traceable, n=80

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

Sodium 140.1 0.5107 0.36 0.7747 0.55
Potassium 4.00 0.0171 0.43 0.0273 0.68
Chloride - - - - -
ionized Calcium 1.166 0.0077 0.66 0.0141 1.21
Table 4-4 Acetat - standard solution (Level 2), NIST Traceable, n=80

Material: tonometered human whole blood, 20 different probands, n=80

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

pH 7.441 0.0042 0.06 - -
PCO2 18.3 0.3331 1.82 0.6262 3.42
PO2 137.9 0.9371 0.68 2.3258 1.69
Sodium 139.5 0.4878 0.35 - -
Potassium 4.58 0.0260 0.57 - -
Chloride 108.4 0.4310 0.40 - -
ionized Calcium 1.181 0.0079 0.67 - -
Hct 43.3 0.3203 0.74 - -
Lactate 11.5 0.1769 1.54 - -
Glucose 1.8 0.0648 3.51 - -
Urea 4.8 0.0529 1.11 - -
tHb (tHb module) 15.4 0.1461 0.95 - -
SO2 (tHb module) 96.6 0.3744 0.39 - -
tHb (COOX) 14.1 0.0773 0.55 - -
SO2 (COOX) 99.9 0.0613 0.06 - -
O2Hb 97.9 0.0684 0.07 - -
COHb 1.4 0.0377 2.79 - -
MetHb 0.7 0.0287 4.10 - -
HHb 0.1 0.0601 - - -
Table 4-5 Tonometered human whole blood, 20 different probands, n=80

Material: tonometered human whole blood, 20 different probands, n=80

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

pH 7.129 0.0049 0.07 - -
PCO2 79.5 1.2629 1.59 1.9644 2.47
PO2 40.1 0.3297 0.82 0.5976 1.49
Sodium 142.3 0.7126 0.50 - -
Potassium 4.32 0.0392 0.91 - -
Chloride 105.2 0.5184 0.49 - -
ionized Calcium 1.301 0.0136 1.05 - -
Hct 40.4 0.2795 0.69 - -
Lactate 8.7 0.2021 2.33 - -
Table 4-6 Tonometered human whole blood, 20 different probands, n=80

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Performance data

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

Glucose 2.3 0.0977 4.31 - -
Urea 4.9 0.0583 1.18 - -
tHb (tHb module) 15.9 0.1315 0.83 - -
SO2 (tHb module) 55.0 0.8839 1.61 - -
tHb (COOX) 14.1 0.1691 1.20 - -
SO2 (COOX) 67.8 0.2479 0.37 - -
O2Hb 66.9 0.3437 0.51 - -
COHb 1.6 0.0549 3.53 - -
MetHb 0.4 0.0504 12.14 - -
HHb 31.5 0.3121 0.99 - -
Table 4-6 Tonometered human whole blood, 20 different probands, n=80

Material: human plasma, n=80

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

pH 7.670 0.0097 0.13 0.0549 0.72
PCO2 - - - - -
PO2 - - - - -
Sodium 140.9 0.7783 0.55 0.9920 0.70
Potassium 3.99 0.0514 1.29 0.0603 1.51
Chloride 106.0 0.4967 0.47 0.7877 0.74
ionized Calcium 1.155 0.0174 1.51 0.0339 2.94
Hct - - - - -
Lactate 2.3 0.0349 1.52 0.1150 5.00
Glucose 5.7 0.0818 1.44 0.1695 2.97
Urea 4.8 0.0873 1.81 0.1005 2.08
Table 4-7 Human plasma, n=80

Material: serum, n=80

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

pH 7.731 0.0120 0.15 0.0334 0.43
PCO2 - - - - -
PO2 - - - - -
Sodium 140.2 0.3226 0.23 0.6567 0.47
Potassium 4.18 0.0149 0.36 0.0330 0.79
Chloride 105.2 0.4310 0.41 0.6871 0.65
ionized Calcium 1.098 0.0092 0.84 0.0323 2.94
Hct - - - - -
Lactate 2.3 0.0353 1.53 0.0989 4.30
Glucose 5.1 0.0737 1.45 0.1834 3.62
Urea 5.2 0.0451 0.86 0.1197 2.29
Table 4-8 Serum, n=80

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Performance data

Material: bicarbonate, n=80

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

Sodium 137.9 0.7201 0.52 1.0185 0.74
Potassium 2.00 0.0224 1.12 0.0301 1.51
Chloride - - - - -
ionized Calcium 1.605 0.0091 0.57 0.0167 1.04
Table 4-9 Bicarbonate, n=80

Material: AUTOTROL PLUS B Level 1, n=40

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

pH 7.182 0.0039 0.05 0.0060 0.08
PCO2 65.8 0.8109 1.23 1.7861 2.72
PO2 55.4 3.6232 6.53 4.5447 8.20
Sodium 121.2 0.6188 0.51 1.1226 0.93
Potassium 2.97 0.0161 0.54 0.0283 0.95
Chloride 84.2 0.4971 0.59 1.6465 1.96
ionized Calcium 1.557 0.0089 0.57 0.0153 0.98
Hct 51.8 0.9534 1.84 1.1250 2.17
Lactate 9.2 0.0821 0.89 0.4539 4.92
Glucose 5.4 0.0612 1.12 0.1299 2.38
Urea 23.5 0.3307 1.41 0.6664 2.84
tHb (tHb module) - - - - -
SO2 (tHb module) - - - - -
tHb (COOX) 7.8 0.0317 0.41 0.0599 0.77
SO2 (COOX) 72.1 0.0690 0.10 0.1941 0.27
O2Hb 46.8 0.0844 0.18 0.2383 0.51
COHb 23.0 0.0371 0.16 0.1043 0.45
MetHb 12.0 0.0180 0.15 0.0513 0.43
HHb 18.1 0.0294 0.16 0.0830 0.46
Bili 6.1 0.0287 0.47 0.0477 0.78
Table 4-10 AUTOTROL PLUS B Level 1, n=40

Material: AUTOTROL PLUS B Level 2, n=40

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

pH 7.411 0.0031 0.04 0.0047 0.06
PCO2 41.0 0.4626 1.13 0.7116 1.74
PO2 93.2 2.9752 3.19 5.0160 5.38
Sodium 139.6 0.3827 0.27 0.7718 0.55
Potassium 4.76 0.0131 0.27 0.0250 0.53
Chloride 101.0 0.3290 0.33 0.9795 0.97
ionized Calcium 1.154 0.0064 0.55 0.0138 1.20
Hct 38.6 0.2840 0.74 0.6195 1.60
Table 4-11 AUTOTROL PLUS B Level 2, n=40

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Performance data

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

Lactate 1.9 0.0135 0.70 0.0798 4.12
Glucose 2.4 0.0197 0.81 0.1172 4.83
Urea 7.3 0.0538 0.74 0.1939 2.67
tHb (tHb module) - - - - -
SO2 (tHb module) - - - - -
tHb (COOX) 12.1 0.0715 0.59 0.1182 0.98
SO2 (COOX) 89.6 0.1442 0.16 0.1507 0.17
O2Hb 74.3 0.2843 0.38 0.3011 0.41
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 4-11 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 4-12 AUTOTROL PLUS B Level 3, n=40

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Performance data

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
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 4-13 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
Table 4-14 AUTOTROL PLUS B Level 5B, n=40

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Performance data

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

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 4-14 AUTOTROL PLUS B Level 5B, n=40

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 4-15 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 4-16

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Performance data

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
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 4-17 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 4-18 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
Table 4-19 AUTOTROL TS+ Level 5A, n=40

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Performance data

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

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 4-19 AUTOTROL TS+ Level 5A, n=40

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 4-20 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 4-21 MSS Level 2, NIST Traceable, n=80

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

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

Bili 8.2 0.1202 1.47 0.6198 7.56
Table 4-22 Human whole blood including bilirubin Level 1, n=40

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

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

Bili 24.1 0.1171 0.49 0.9663 4.01
Table 4-23 Human whole blood including bilirubin Level 2, n=40

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

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

Bili 44.0 0.1623 0.37 2.1509 4.89
Table 4-24 Human whole blood including bilirubin Level 3, n=40

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Performance data

Linearity

Tonometered whole blood Whole blood was tonometered at 37 °C to various levels 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.

Aqueous Solutions Expected values for the aqueous solutions are based on weighted samples.

NIST standards NIST standards are precise serums with accredited target values.

Hematocrit Measurement results of the hemofuge, which is representing the Golden Standard for
hematocrit measurements, are used as expected values for hematocrit results.

Human whole blood including Expected bilirubin values for human whole blood including bilirubin are based on
bilirubin weighted samples.

Parameter: PO2 (mmHg)

Material: tonometered whole blood
Number of instruments: 4 cobas b 221 systems
Measurements per measuring point and instrument: 5

Expected value Mean Swr Recovery

55.39 55.66 0.4860 100.5
83.83 83.45 0.4982 99.5
103.55 103.16 0.9034 99.6
216.97 218.54 1.9437 100.7
Table 4-25 Parameter PO2 (mmHg)

Correlation
Slope 0.9904 - 1.0097
Intercept ± 0.857
Correlation coefficient 0.9998
Table 4-26

Parameter: PCO2 (mmHg)

Material: Tonometered whole blood
Number of instruments: 4 cobas b 221 systems
Measurements per measuring point and instrument: 5

Expected value Mean Swr Recovery

14.90 13.78 0.1141 92.5
39.74 37.78 0.3911 95.1
119.43 117.09 1.3505 98.0
Table 4-27 Parameter PCO2 (mmHg)

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Performance data

Correlation
Slope 0.9898 - 1.0103
Intercept ± 1.225
Correlation coefficient 0.9999
Table 4-28

Parameter: pH (pH units)

Material: Tonometered whole blood
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 5

Expected value Mean Swr Recovery

7.52 7.52 0.0050 100
7.32 7.32 0.0042 100
6.98 6.99 0.0066 100.1
Table 4-29 Parameter pH (pH units)

Correlation
Slope 0.9825 - 1.0178
Intercept ± 0.133
Correlation coefficient 0.9998
Table 4-30

Parameter: Hct (%)

Material: human whole blood, traceable to golden standard (micro centrifuge)
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 5

Expected value Mean Swr Recovery

11.00 11.72 0.4146 106.5
24.00 23.60 0.1804 98.3
36.00 36.51 1.0171 101.4
48.00 49.73 1.0046 103.6
68.00 68.16 0.2210 100.2
78.00 77.80 0.3925 99.7
Table 4-31 Parameter Hct (%)

Correlation
Slope 0.997 - 1.003
Intercept ± 0.620
Correlation coefficient 0.999
Table 4-32

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Performance data

Parameter: sodium (mmol/L)

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

Expected value Mean Swr Recovery

19.85 21.25 0.4979 107.1
91.52 92.44 0.3018 101.0
153.49 154.83 0.3808 100.9
205.66 208.30 0.5619 101.3
258.42 262.68 1.6465 101.6
Table 4-33 Parameter Sodium (mmol/L)

Correlation
Slope 0.988 - 1.012
Intercept ± 0.365
Correlation coefficient 0.9999
Table 4-34

Parameter: potassium (mmol/L)

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

Expected value Mean Swr Recovery

0.23 0.26 0.0159 115.0
3.12 3.12 0.0114 100.0
5.11 5.13 0.0144 100.4
9.96 10.16 0.0378 102.0
14.71 15.19 0.0624 103.3
19.36 20.15 0.0757 104.1
Table 4-35 Parameter Potassium (mmol/L)

Correlation
Slope 0.960 - 1.042
Intercept ± 0.109
Correlation coefficient 0.9999
Table 4-36

Parameter: ionized Calcium (mmol/L)

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

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Performance data

Expected value Mean Swr Recovery

0.10 0.09 0.0042 92.0
0.80 0.76 0.0067 94.7
1.25 1.19 0.0055 95.2
2.50 2.39 0.0122 95.7
4.00 3.86 0.0225 96.5
6.00 5.84 0.0347 97.4
Table 4-37 Parameter ionized Calcium (mmol/L)

Correlation
Slope 0.975 - 1.026
Intercept ± 0.024
Correlation coefficient 0.9999
Table 4-38

Parameter: chloride (mmol/L)

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

Expected value Mean Swr Recovery

24.86 25.84 0.5081 103.9
93.20 93.08 0.2241 99.9
149.34 146.85 0.3541 98.3
194.98 190.16 0.6110 97.5
239.86 232.04 1.0721 96.7
Table 4-39 Parameter Chloride (mmol/L)

Correlation
Slope 0.959 - 1.043
Intercept ± 2.908
Correlation coefficient 0.9999
Table 4-40

Parameter: pH (pH units)

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

Expected value Mean Swr Recovery

6.20 6.24 0.0022 100.7
6.87 6.89 0.0024 100.2
7.38 7.38 0.0023 100.1
7.70 7.67 0.0023 99.7
8.00 7.97 0.0035 99.7
Table 4-41 Parameter pH (pH units)
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Performance data

Correlation
Slope 0.960 - 1.042
Intercept ± 0.293
Correlation coefficient 1.0000
Table 4-42

Parameter: CO2 (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 0.9719 - 1.0289
Intercept ± 4.0475
Correlation coefficient 0.9999
Table 4-56

Parameter: potassium (mmol/L)

Material: NIST 956a
Number of instruments: 4 cobas b 221 systems
Measurements per level and instrument: 15

Expected value Mean Swr Recovery

6.01 6.04 0.0202 100.6
3.99 4.00 0.0103 100.3
2.03 1.91 0.0209 94.1
Table 4-57 Parameter Potassium (mmol/L)

Correlation
Slope 0.9629 - 1.0385
Intercept ± 0.1788
Correlation coefficient 0.9999
Table 4-58

Parameter: sodium (mmol/L)

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

Expected value Mean Swr Recovery

120.76 119.96 0.3662 99.3
141.00 144.31 0.4298 102.3
Table 4-59 Parameter Sodium (mmol/L)

Correlation
Slope 0.8311 - 1.2032
Intercept ± 25.3383
Correlation coefficient 0.9997
Table 4-60

Parameter: potassium (mmol/L)

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

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Performance data

Expected value Mean Swr Recovery

3.42 3.29 0.0162 96.1
6.28 6.56 0.0273 104.4
Table 4-61 Parameter Potassium (mmol/L)

Correlation
Slope 0.8738 - 1.1444
Intercept ± 0.6284
Correlation coefficient 1.0000
Table 4-62

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 4-63 Parameter Chloride (mmol/L)

Correlation
Slope 0.9032 - 1.1072
Intercept ± 8.1053
Correlation coefficient 0.9990
Table 4-64

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 4-65 Parameter Glucose (mmol/L)

Correlation
Slope 0.7429 - 1.3461
Intercept ± 1.0482
Correlation coefficient 0.9997
Table 4-66

Parameter: urea (mmol/L)

Material: NIST 909b
Number of instruments: 4 cobas b 221 systems
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Performance data

Measurements per level and instrument: 15

Expected value Mean Swr Recovery

5.51 5.40 0.0248 98.0
Table 4-67 Parameter Urea (mmol/L)

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

Material: Tonometered whole blood
Number of instruments: 4 cobas b 221 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 4-68 Parameter tHb (g/dL), SO2 (%)

Parameter: bilirubin (mg/dL)

Material: human whole blood including 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 4-69 Parameter Bilirubin (mg/dL)

Correlation
Slope 0.9038 - 1.1064
Intercept ± 1.514
Correlation coefficient 0.9996
Table 4-70

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
pH meter(1) Y = 0.9963*X 0 0.999 20

Table 4-71 pH
(1) pleural fluid - pH measuring instrument, temperature-corrected

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Performance data

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 4-72 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 4-73 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 4-74 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 4-75 SO2

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 4-76 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 4-77 O2Hb

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Performance data

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 4-78 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 4-79 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 4-80 COHb

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 4-81 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 4-82 Bilirubin

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Performance data

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 4-83 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 4-84 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 4-85 Potassium

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 4-86 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 4-87 Chloride

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Performance data

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 4-88 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 4-89 Urea

Lactate
Unit: [mmol/L]

sample.

Activated/installed modules Typical sample volume Typical sample volume Max. sample volume
[μL](1) [μL](2) (volume limitation by the
sample sensor) [μL](3)
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 4-93 Sample volumes
(1) typical sample volume for Hct  45%
(2) typical sample volume for 45%  Hct  75%: if a sample with high Hct is expected, the sample volume for high Hct is recommended.
(3) The sample volume limitation is the maximum volume of sample which is aspirated from the container.

Q 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 4-94 Sample container

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Sample types

Sample types

o Whole blood
o Serum
o Plasma(1)
o Dialysis solutions containing acetate and bicarbonate(2)
o Recommended QC material(3)

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

(2) only for electrolytes
(3) with approximate physiological ion matrix and buffer capacity

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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(1) 32 43
Warm-up phase power failure < 1 minute 2.5 2.5
Electrode exchange as needed 25 50
Table 4-95 Calibrations
(1) including calibration

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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)
Table 4-96

Storage and transportation conditions

o Temperature -20 to 50 °C
o Humidity 20 to 85% (not condensed)
o Shock resistance < 30 g
Table 4-97

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%
Table 4-98

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)
Table 4-99

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Environmental parameters

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 5 days
o Humidity 20 to 85% (not condensed) over a period of 3 days
o Shock resistance < 30 g
Table 4-100

Solutions

Operating conditions
o Ambient temperature 15 to 35 °C
o Relative humidity 20 to 85%
Table 4-101

Storage conditions in original packaging

o Temperature
S1 rinse Solution 2 to 30 °C (24 months(1))
S2 fluid Pack
2 to 30 °C (18 months(1))
S3 fluid Pack
2 to 25 °C (18 months(1))
o Relative humidity 20 to 85%
Table 4-102
(1) storage time contains also transportation time and the storage time in Mannheim, Germany.

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
Table 4-103

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, 6
Urea/BUN
Table 4-104

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
Table 4-105

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Environmental parameters

Storage conditions in original packaging

cobas b 221<1>/<3>/<5> system
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
Table 4-105

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
(including 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
(including up to 60 days in the AutoQC module)
Table 4-106

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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): approximately 45 kg (without wash/calibrating

solutions and AutoQC)

Acoustic noise level

In all operating conditions: min. 37.0 dB

max. 51.8 dB

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AutoQC

Holding points

Warning
r Take care when lifting - weight of the instrument without wash/calibrating solutions
WARNING and AutoQC is approximately 45 kg.

Figure 4-1 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

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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 Hard disk
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 Hard disk
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 Hard disk
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

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Barcode scanner

Barcode scanner

Type: MS180 PS2 hand scanner with integrated decoder

Reading speed: up to 33 scans/s
Resolution: 0.1 mm
Reading distance: up to 5 cm
Reading width: up to 8 cm
Preprogrammed code types(1): o UPC-A
o UPC-E
o EAN-8
o EAN-13
o EAN-128
o Interleave 2 of 5
o Code 39
o Code 93
o Code 128
(1) Further available barcode types can be programmed in accordance with the enclosed manual of the
PS2 hand-held scanner (included in scope of delivery).

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Table of contents

Theoretical foundations 5

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............................................................................................. 117
Conversion table for units.......................................................................................... 117
Temperature........................................................................................................... 117
Standard values and ranges........................................................................................ 117
Equations...................................................................................................................... 118
H+ ........................................................................................................................... 118
cHCO3- .................................................................................................................. 118
ctCO2(P) ................................................................................................................ 118
FO2Hb.................................................................................................................... 119
BE ............................................................................................................................ 119
BEecf....................................................................................................................... 119
BB............................................................................................................................ 119
SO2.......................................................................................................................... 120
SO2(c)..................................................................................................................... 120
P50 .......................................................................................................................... 121
ctO2 ........................................................................................................................ 121
ctCO2(B)................................................................................................................ 122
pHst......................................................................................................................... 122
cHCO3-st ............................................................................................................... 122
PAO2....................................................................................................................... 123
AaDO2 ................................................................................................................... 123
a/AO2 ..................................................................................................................... 123
avDO2 .................................................................................................................... 123
RI............................................................................................................................. 124
Shunt....................................................................................................................... 124
nCa2+ ..................................................................................................................... 125
AG ........................................................................................................................... 126
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Table of contents

pHt .......................................................................................................................... 126

H+t.......................................................................................................................... 126
PCO2t..................................................................................................................... 126
PO2t........................................................................................................................ 126
PAO2t ..................................................................................................................... 127
AaDO2t .................................................................................................................. 127
a/AO2t .................................................................................................................... 127
RIt............................................................................................................................ 127
Hct(c)...................................................................................................................... 128
MCHC .................................................................................................................... 128
BO2 ......................................................................................................................... 128
BEact....................................................................................................................... 128
Osmolality.............................................................................................................. 129
OER......................................................................................................................... 129
Heart minute volume (Qt)................................................................................... 130
P/F Index................................................................................................................ 130
Lactate Clearance .................................................................................................. 130
Bibliography................................................................................................................. 131
Reference and critical values............................................................................................ 132
pH.................................................................................................................................. 132
PO2 ............................................................................................................................... 133
PCO2 ............................................................................................................................ 133
Sodium ......................................................................................................................... 134
Potassium ..................................................................................................................... 134
Chloride........................................................................................................................ 135
Ionized calcium ........................................................................................................... 135
Hematocrit ................................................................................................................... 135
tHb (total hemoglobin concentration)..................................................................... 136
Oxygen saturation (SO2) ........................................................................................... 137
Oxyhemoglobin (O2Hb)............................................................................................ 137
Desoxyhemoglobin (HHb) ........................................................................................ 138
Carboxyhemoglobin (COHb) ................................................................................... 138
Methemoglobin (MetHb) .......................................................................................... 138
Total bilirubin (=neonatal) ........................................................................................ 138
Glucose ......................................................................................................................... 139
Lactate........................................................................................................................... 139
Urea/BUN .................................................................................................................... 140

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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 stated otherwise, all
measurement values that are used in the equations were measured at 37 °C.

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

Ca2+ 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 5-1 Conversion table for units

Temperature
9
Equation 5-1 T  F  = ---  T  C  + 32
5

Equation 5-2 T  C  = 5---   T  F  – 32 

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
Table 5-2 Standard values and ranges

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Parameters and calculations

Parameter Standard value Possible range

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 5-2 Standard values and ranges

Equations

Q All not listet equations are not realized.

Q 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.

Q 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 5-3

H+ = 10(9-pH)

cHCO3-

Bicarbonate concentration in plasma.[1]

Unit: [mmol/L]
Equation 5-4

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 5-5

ctCO2(P) = cHCO3- + (0.0307 * PCO2)

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Parameters and calculations

FO2Hb

Fractional oxygen saturation[1]

Unit: [-]
Equation 5-6

O 2 Hb
FO 2 Hb = --------------
-
100

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]
Equation 5-7

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

−

U For BEact see Equation 5-40 (p. 128).

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]
Equation 5-8

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

−

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 5-9

BB = BE + 41.7 + 0.42 ⋅ tHb

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Parameters and calculations

SO2
The quantity of oxyhemoglobin in the blood related to the quantity of hemoglobin in
the blood which can bind oxygen.[1]
Unit: [%]

COOX module: Equation 5-10

O 2 Hb
SO 2 = ⋅100
O 2 Hb + HHb

tHb/SO2 module SO2 is measured

SO2(c)
No SO2 data available:

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

No calculation without pH, PO2 or BE.

Unit: [%] [7], [8]

Equation 5-11

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

At which:
Equation 5-12

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

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

Adult [7] P50 = 26.7

F1 = 1.661
F2 = 0.074
F3 = 4.172

Fetal[7] P50 = 21.5

F1 = 1.3632
F2 = 0.0533
F3 = 4.113

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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).[7], [8]
The cobas b 221 system enables the derivation of the P50 from SO2%, PO2 and pH.
Unit: [mmHg]
Measured SO2 values available:
Equation 5-13

P 50 = 26.7⋅10 (lgPO 2 −lgPO 2 )

At which:
Equation 5-14

(lg Q + F3)
lg PO 2 =
k

2.9
SO 2
Q=
100% − SO 2

Adult [7] F3 = 4.172

Fetal [7] F3 = 4.113

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

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%]
Equation 5-15

X
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)
U see equation SO2 (p. 120)
If PO2 is not available, ctO2 is calculated with PO2 = 90 mmHg.

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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).[10]
Unit: [mmol/L]
Equation 5-16

ctCO 2 (B) =
tHb
0.000768 ⋅ PCO 2 ⋅ tHb ⋅ (1 + 10(pH ERY − pK ERY ) ) + ctCO 2 (P) ⋅ (1 − )
33.8

At which:
Equation 5-17

SO 2
pH ERY = 7.19 + 0.77 ⋅ (pH − 7.4) + 0.035 ⋅ (1 − )
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 5-8 (p. 119).

Q 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.[7]
Unit: [pH unit]
Equation 5-18

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

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.[7]
Unit: [mmol/L]
Equation 5-19

= 10 (pH st − 6.022 )
−
cHCO3 st

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PAO2
The alveolar oxygen partial pressure is used to calculate several parameters used for
oxidation and breathing.[6]
Unit: [mmHg]
Equation 5-20

ª 1 − FIO 2 º
PAO 2 = ( Ptotal − 47)⋅FIO2 − PACO 2 ⋅« FIO2 +
¬ R »¼

If the result of the calculation is PAO2 < PO2, PAO2 = PO2 is set. PACO2
corresponds to the measured PCO2.
U For t unequal 37°C see equation PAO2t (p. 127)

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. [6]
Unit: [mmHg]
Equation 5-21

AaDO2 = PA O2 - Pa O2

U For t unequal 37°C see equation AaDO2t (p. 127)

a/AO2

Arterial alveolar oxygen partial pressure ratio.[6]

Unit: [%]
Equation 5-22

PaO 2
a/AO 2 = ⋅100
PAO2

U For t unequal 37°C see equation a/AO2t (p. 127)

avDO2

The arterial venous oxygen tension ratio.[1]

Unit: [vol%]
Formula - data from venous blood available:
Equation 5-23

avDO 2 = ctO 2 ( a ) ctO 2 ( v )

Calculated ctO2(a) and ctO2(v) according to the calculation for ctO2 for arterial and
venous blood.
U for ctO2 see Equation 5-11 (p. 120)

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Parameters and calculations

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.[6]
Unit: [%]
Equation 5-24

( PAO 2 − PaO 2 )
RI = ⋅ 100
PaO 2

U For t unequal 37°C see Equation 5-34 (p. 127)

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).[6]
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.

Warning
r With a combination of arterial and venous blood, the Qs/Qt value cannot be
WARNING determined.
r Samples from patients with other patient ID can be measured between the two Qs/Qt
partial measurements.
r 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.

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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: [%]
Equation 5-25

SaO 2
100 ⋅ [1.39 ⋅ tHb ⋅ (1 − ) + (PAO 2 − PaO 2 ) ⋅ 0.00314]
Qs 100
=
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 5-15 (p. 121) for arterial
and mixed venous blood:
U for ctO2 see Equation 5-15 (p. 121)
If no measurement data is available for mixed venous blood, then the following is
valid:
Equation 5-26

ctO2(a)-ctO2(v) = 5.15 vol%

nCa2+

The ionized calcium value standardized to pH = 7.40.[5]

Unit: [mmol/L]
Equation 5-27

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.

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Parameters and calculations

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 5-28

−
AG = Na + + K + - Cl - - cHCO 3

pHt

pH corrected to patient temperature other than 37 °C.[1]

Unit: [pH-Unit]
Equation 5-29

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]
Equation 5-30

H + t = 10 (9− pH )
t

PCO2t

PCO2 value at a patient temperature which is not 37 °C.[1]

Unit: [mmHg]
Equation 5-31

PCO 2 t = PCO 2 ⋅ 100.019⋅( t−37)

PO2t

PO2 value at a patient temperature which is not 37 °C.[1]

Unit: [mmHg]
Equation 5-32

ª 5.49⋅10 −11 ⋅PO 2 3.88 + 0.071º

« −9 3.88 » ⋅( t − 37 )
t ¬« 9.72⋅10 ⋅PO 2 + 2.30 ¼»
PO 2 = PO 2 ⋅ 10

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PAO2t

Alveolar oxygen partial pressure at a patient temperature other than 37 °C.[6]

Unit: [mmHg]
Equation 5-33

§ 1 − FIO 2 ·º
( ) t ª
PAO 2 = Ptotal − PH 2 O t ⋅ FIO 2 − PACO 2 ⋅ « FIO 2 + ¨
t
¸»
¬ © R ¹¼

PAO 2t ≤ PO 2t otherwise PAO 2 t = PO 2t

for:

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

PH 2 O t = 47 ⋅10
with:

AaDO2t

Alveolar oxygen partial pressure at a patient temperature other than 37 °C.[6]

Unit: [mmHg]
Equation 5-34

AaDO 2 t = PAO 2 t − PaO 2 t

a/AO2t

Arterial alveolar oxygen partial pressure ratio at the patient’s temperature.[6]

Unit: [%]
Equation 5-35

PaO 2
t
a/AO2 = ⋅100
t

PAO 2
t

RIt

Respiratory index corrected to patient temperature other than 37 °C.[6]

Unit: [%]
Equation 5-36

( PAO 2 − PaO 2 )
t t
RI t = ⋅100
PaO 2
t

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Parameters and calculations

Hct(c)

Hct as a function of tHb.[4]

Equation 5-37

F
Hct(c) = tHb ⋅
100

Default value of F = 3.00 (F = 100/MCHC [g/dL])[9]

Input range: 2.70 to 3.30.
This corresponds to an MCHC of 30.3 to 37 g/dL (= reference range for adults).[4]

Q Only measured tHb is permitted.

MCHC

Mean corpuscular hemoglobin concentration.[4]

Units: [g (Hb)/dL (Ery)]
Equation 5-38

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

BO2

Oxygen capacity.[1]
Unit: [vol%]
Equation 5-39

ª (COHb − MetHb − SulfHb ) º

BO 2 = tHb ⋅ «1 − »¼ ⋅1.39
¬ 100

SulfHb = 0, if SulfHb is not measured.

BEact

Base deviation at actual oxygen saturation.[2]

Unit: [mmol/L]
Equation 5-40

BEact = (1 - 0.0143⋅ tHb) ⋅ [(1.63 ⋅ tHb + 9.5) ⋅ (pH − 7.4) − 24.26 + cHCO3− ] −
§ SO ·
− 0.2 ⋅ tHb⋅ ¨1− 2 ¸
© 100 ¹

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Osmolality

Unit: [mOsm/kg][3]
Equation for blood, plasma, serum:
Equation 5-41

Osm = 1.86 ⋅ Na + + Glu + Urea + 9

Equation for aqueous solution, acetate, bicarbonate:
Equation 5-42

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
2+
Ca : if no measurement value is available, the default value is used for the calculation
2+
Mg : 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.[1]

Unit: [%]
Equation 5-43

(ctO 2(a) − ctO 2(v) )

OER = ⋅ 100
ctO 2(a)

U for ctO2 see Equation 5-15 (p. 121)

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

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Heart minute volume (Qt)

Unit: [vol%][6]
Equation 5-44

Q t = ctO2 (A) − ctO2 (v)

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 [6]

Unit: [mm/Hg]
Equation 5-45

PaO 2
P/F Index =
FIO 2

Lactate Clearance
The Lactate Clearance (LacClear) calculates the hourly change in percent of the
measured lactate.[10], [11]
The determination of the Lactate Clearance requires two independent measurements.

Q Note:
Both measurements must be carried out with the same patient ID.
The patient ID must therefore be defined as an input value.

Warning
r Samples from patients with other patient IDs can be measured between the two lactate
WARNING partial measurements.
r For calculating Lactate Clearance, either the current or the historic lactate value must
be greater than 4 mmol/L.
r At least 2 hours must pass between the two lactate partial measurements, but no more
than 8 hours.

Unit: [%]
Equation 5-46

Lac hist Lac h

LacClear = -------------------------------- ⋅ 100 ⋅ ---
Lac hist Δ

Lac is the latest measured lactate value

Lachist is the historical lactate value
h h=1
Δ is the time interval between the both lactate measurements

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Bibliography

[1] Clinical and Laboratory Standards Institute. Blood gas and pH related measurements,
CLSI document C46-A2; Approved Guideline (2001), Vol. 29 No. 8.

[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.
4th Edition. W.B. Saunders Company, 2006; p. 992.

[4] Thomas, Lothar: Labor und Diagnose: Indikation und Bewertung von
Laborbefunden für die medizinische Diagnostik; 7. Auflage. Frankfurt am Main:
TH- Books- Verl.- Ges., 2008, S. 677 f.

[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. Lab. Invest., 43, Suppl. 165, 79-82, 1983.

[6] National Committee on Clinical Laboratory Standards. Defintions of Quantities and

Conventions Related to Blood pH and Gas Analysis, NCCLS Document C12-A;
Approved Standard (1994), Vol. 14 No. 11.

[7] Marsoner, Hermann J.: Medequip 82 - Geräte, Instrumente, Materialien,

Diagnostica, Einrichtungen für die Medizin- Jahrgang 1982, Heft 2, Seite 37 - 42.

[8] Marsoner, H. J.; Harnoncourt, K.: The Calculation of the Oxygen Saturation as
Function of pO2, pH, Temperature and base Deviation; Anaesthesist 25, 345 - 348
(1976).

[9] Despopoulos, Agamemmon; Silbernagel, Stefan: Color Atlas of Physiology, Georg

Thieme Verlag Stuttgart, New York 1991, 4th edition, p. 60.

[10] Siggaard-Anderson, O.; Wimberley, P. D.; Fogh-Anderson, N.; Gøthgen, I. H.:

Measured and derived quantities with modern pH and blood gas equipment:
calculation algorithms with 54 equations; Scand. J. Clin. Lab. Invest. 1988, 48,
Suppl. 189: 7-15.

[11] H. Bryant Nguyen; Manisha Loomba; James J. Yang; Gordon Jacobsen; Kant Shah;
Ronny M. Otero; Arturo Suarez; Hemal Parekh; Anja Jaehne; Emanuel P. Rivers:
Early lactate clearance is associated with biomarkers of inflammation, coagulation,
apoptosis, organ dysfunction and mortality in severe sepsis and septic shock; Journal
of Inflammation 2010, 7:6.

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Reference and critical values

Reference and critical values

The result of laboratory tests have little practical utility until clinical studies have
ascribed various states of health and disease to intervals of values.(1)
Reference intervals are useful because they attempt to describe the typical results
found in a defined population of apparently healthy people. Different methods may
yield different values, depending on calibration and other technical considerations.
Hence, different reference intervals and results may be obtained in different
laboratories.
Reference intervals, although useful as guideline for clinicians, should not be used as
absolute indicators of health and disease.(2)

Warning
r The reference intervals presented in this chapter are for general information purposes
WARNING only.
r Individual laboratories should generate their own set of reference intervals.

Reference values:
o Whole blood, arterial:(1) Cord blood 7.18 - 7.38
o Whole blood, venous:(1) Cord blood 7.25 - 7.45
o Whole blood, arterial:(1) Newborn Premature, 48 h 7.35 - 7.50
Newborn Fullterm, birth 7.11 - 7.36
Newborn Fullterm, 5 - 10 min. 7.09 - 7.30
Newborn Fullterm, 30 min. 7.21 - 7.38
Newborn Fullterm, 1 h 7.26 - 7.49
Newborn Fullterm, 1 day 7.29 - 7.45
o Whole blood, arterial:(1) Adult, children 7.35 - 7.45
o Whole blood, venous:(1) Adult, children 7.32 - 7.43
o Whole blood, arterial:(1) Adult 60 - 90 years 7.31 - 7.42
Adult > 90 years 7.26 - 7.43
o Whole blood, mixed-venous:(2) 7.35 - 7.43
Table 5-3
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2289
(2) Labor und Diagnose: Indikation und Bewertung von Laborbefunden für die medizinische Diagnostik, Thomas Lothar, 7. Auflage, S. 470

Critical values: Lower Limit Upper Limit

Critical values: Lower Limit Upper Limit

o Plasma:(1) Adult 0.75 mmol/L or 3.01 mg/dL 1.6 mmol/L or 6.41 mg/dL
Table 5-16
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2317

Hematocrit

Reference values: % Packed Red Cell Volume fraction:

Volume:
o Whole blood:(1) Adult Caucasian, female 36 - 48 0.36 - 0.48
Adult Caucasian, male 40 - 53 0.40 - 0.53
Adult Afro, female 34 - 43 0.34 - 0.43
Adult Afro, male 34 - 48 0.34 - 0.48
Adult Athlete, female 37 - 45 0.37 - 0.45
Adult Athlete, male 40 - 50 0.40 - 0.50
Table 5-17

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Reference values: % Packed Red Cell Volume fraction:

Volume:
Fetus Week of gestation: 15 28 - 42 0.28 - 0.42
Fetus Week of gestation: 16 34 - 42 0.34 - 0.42
Fetus Week of gestation: 17 31 - 43 0.31 - 0.43
Fetus Week of gestation: 18 - 21 31 - 45 0.31 - 0.45
Fetus Week of gestation: 22 - 25 31 - 47 0.31 - 0.47
Fetus Week of gestation: 26 - 29 32 - 50 0.32 - 0.50
Fetus Week of gestation: > 30 30 - 58 0.30 - 0.58
Newborn Cord blood 48 - 56 0.48 - 0.56
Infant 2 - 6 days 40 - 70 0.40 - 0.70
Infant 1 - 2 weeks 38 - 70 0.38 - 0.70
Infant 2 - 3 weeks 38 - 60 0.38 - 0.60
Infant 3 - 7 weeks 36 - 46 0.36 - 0.46
Infant 7 - 12 weeks 30 - 38 0.30 - 0.38
Infant 10 - 12 months 35 - 43 0.35 - 0.43
Children 4 - 5 yrs 32 - 40 0.32 - 0.40
Children 6 - 8 yrs 32 - 41 0.32 - 0.41
Children 10 - 13 years 34 - 44 0.34 - 0.44
Children, female 14 - 16 years 35 - 43 0.35 - 0.43
Children, male 14 - 16 years 38 - 49 0.38 - 0.49
o Whole blood, venous Newborn 2 hours after birth 49 - 71 0.49 - 0.71
Newborn 6 hours after birth 44 - 68 0.44 - 0.68
Table 5-17
(1) Labor und Diagnose: Indikation und Bewertung von Laborbefunden für die medizinische Diagnostik, Thomas Lothar, 7. Auflage, S. 693

Critical values: Lower Limit Upper Limit

Adult(1) 20% 60%

Newborn(a) 33% 71%

Table 5-18
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2317

tHb (total hemoglobin concentration)

Reference values: [g/dL] [g/L]

o Whole blood, arterial Adult female 12.0 - 16.0 120 - 160
(heparin):(1)
Adult male 13.5 - 17.5 135 - 175
Fetus Week of gestation: 15 10.9 ± 0.7 109 ± 7
Fetus Week of gestation: 16 12.5 ± 0.8 125 ± 8
Fetus Week of gestation: 17 12.4 ± 0.9 124 ± 9
Fetus Week of gestation: 18 - 21 11.7 ± 1.3 117 ± 13
Fetus Week of gestation: 22 - 25 12.2 ± 1.6 122 ± 16
Fetus Week of gestation: 26 - 29 12.9 ± 1.4 129 ± 14
Table 5-19
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Reference values: [g/dL] [g/L]

Fetus Week of gestation: > 30 13.6 ± 2.2 136 ± 22
Cord blood 13.5 - 20.7 135 - 207
Newborn 1 day 15.2 - 23.5 152 - 235
Newborn 2 - 6 days 15.0 - 24.0 150 - 240
Infant 14 - 23 days 12.7 - 18.7 127 - 187
Infant 24 - 37 days 10.3 - 17.9 103 - 179
Infant 40 - 50 days 9.0 - 16.6 90 - 166
Infant 2.0 - 2.5 months 9.2 - 15.0 92 - 150
Infant 3.0 - 3.5 months 9.6 - 12.8 96 - 128
Infant 5 - 7 months 10.1 - 12.9 101 - 129
Infant 8 - 10 months 10.5 - 12.9 105 - 129
Children 11.0 - 13.5 months 10.7 - 13.1 107 - 131
Children 1.5 - 3 years 10.8 - 12.8 108 - 128
Children 5 years 11.1 - 14.3 111 - 143
Children 10 years 11.9 - 14.7 119 - 147
Children 12 years 11.8 - 15.0 118 - 150
Children 15 years 12.8 - 16.8 128 - 168
Table 5-19
(1) Labor und Diagnose: Indikation und Bewertung von Laborbefunden für die medizinische Diagnostik, Thomas Lothar, 7. Auflage, S. 682

Critical values: Lower Limit Upper Limit

Adult(1) 7 g/dL 20 g/dL

Newborn(a) 10 g/dL 22 g/dL

Table 5-20
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2317

Oxygen saturation (SO2)

Reference values: % Saturation Fraction Saturation

o Whole blood, arterial:(1) Newborn 40 - 90 0.40 - 0.90
Thereafter 94 - 98 0.94 - 0.98
o mixed-venous:(1) 70 - 80 0.70 - 0.80
Table 5-21
(1) Labor und Diagnose: Indikation und Bewertung von Laborbefunden für die medizinische Diagnostik, Thomas Lothar, 7. Auflage, S. 470

Oxyhemoglobin (O2Hb)

Reference values: % O2Hb Fraction O2Hb

o Whole blood:(1) Nonsmoker 94 - 98 0.94 - 0.98
Table 5-22
(1) American enviromental laboratory: The laboratory assessment of oxygenation: Robert F. Morgan: 1993, 5 (4), p. 147 - 153

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Reference and critical values

Desoxyhemoglobin (HHb)

Reference values: % HHb Fraction HHb

o Whole blood:(1) 1-5 0.01 - 0.05
Table 5-23
(1) American environmental laboratory: The laboratory assessment of oxygenation: Robert F. Morgan: 1993, 5 (4), p. 147 - 153

Carboxyhemoglobin (COHb)

Reference values: % COHb Fraction COHb

o Whole blood:(1) Nonsmoker 0.5 - 1.5 0.005 - 0.015
Smoker, 1 - 2 packs/day 4-5 0.04 - 0.05
Smoker, > 2 packs/day 8-9 0.08 - 0.09
Toxic > 20 > 0.20
Lethal > 50 > 0.50
Table 5-24
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2259

Methemoglobin (MetHb)

Reference values:
o Whole blood:(1) 0.06 - 0.24 g/dL 9.3 - 37.2 μmol/L
0.04 - 1.52% of total Hb 0.0004 - 0.0152 mass fraction
of total Hb
Toxic(2) > 15%

Lethal(2) > 70%

Table 5-25
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2259
(2) Labor und Diagnose: Indikation und Bewertung von Laborbefunden für die medizinische Diagnostik, Thomas Lothar, 7. Auflage, S. 698

Total bilirubin (=neonatal)

Reference values: [mg/dL] [μmol/L]

o Serum:(1) Cord, premature < 2.0 < 34.2
Cord, full term < 2.0 < 34.2
0 - 1. day (premature) 1.0 - 8.0 17 - 187
0 - 1. day (full term) 2.0 - 6.0 34 - 103
1. - 2. day (premature) 6.0 - 12.0 103 - 205
1. - 2. day (full term) 6.0 - 10.0 103 - 171
3. - 5. day (premature) 10.0 - 14.0 171 - 240
3. - 5. day (full term) 4.0 - 8.0 68 - 137
Table 5-26
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2258

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Reference and critical values

Critical values:(1) Lower Limit Upper Limit

o Serum or plasma Newborn --- 15 mg/dL
Table 5-27
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2317

Glucose

Reference values: [mg/dL] [mmol/L]

o Serum, fasting: (1)
Cord blood 45 - 96 2.5 - 5.3
Premature 20 - 60 1.1 - 3.3
Neonate 30 - 60 1.7 - 3.3
Newborn, 1 day 40 - 60 2.2 - 3.3
Newborn, > 1 day 50 - 80 2.8 - 4.5
Child 60 - 100 3.3 - 5.6
Adult 74 - 100 4.1 - 5.6
Adult, > 60 years 82 - 115 4.6 - 6.4
Adult, > 90 years 75 - 121 4.2 - 6.7
o Whole blood (heparin):(1) Adult 65 - 95 3.5 - 5.3
Table 5-28
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2270 f.

Critical values:(1) Lower Limit Upper Limit

o Serum or plasma Adult 40 mg/dL 450 mg/dL
Child 46 mg/dL 445 mg/dL
Newborn 30 mg/dL 325 mg/dL
Table 5-29
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2317

Lactate

Reference values: [mg/dL] [mmol/L]

o Whole blood:(1) venous (at bed rest) 5 - 15 0.56 - 1.39
arterial (at bed rest) 3-7 0.36 - 0.75
Table 5-30
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2282

Critical values:(1) Lower Limit Upper Limit

Adult --- 3.4
Child --- 4.1
Table 5-31
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2317

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Urea/BUN

Reference values (BUN): [mg/dL] [mmol/L]

o Serum(1) Cord blood 21 -40 7.5 - 14.3
Premature (1 week) 3 - 25 1.1 - 8.9
Newborn, 1 day 4- 12 1.4 - 4.3
Infant/child 5 - 18 1.8 - 6.4
Adult 6 - 20 2.1 - 7.1
Adult > 60 years 8 - 23 2.9 - 8.2
Table 5-32
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2301.

Critical values (BUN): (1) Lower Limit Upper Limit

Serum oder Plasma Adult --- 80 mg/dL
Children --- 55 mg/dL
Table 5-33
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2317

Conversion BUN > Urea Indication of BUN in mg/dL (mmol/L):

Urea = BUN x 2.14

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Operation

6 Measurement.................................................................................................................................. 143
7 Quality control ............................................................................................................................... 173
8 Calibration ..................................................................................................................................... 211
9 Software modes .............................................................................................................................. 217

February 2014
cobas b 221 system 6 Measurement
Table of contents

Measurement 6

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

In this chapter Chapter 6

Preanalytics ........................................................................................................................ 145
Sample collection ........................................................................................................ 145
Sample acquisition ................................................................................................ 145
Anticoagulants ...................................................................................................... 145
Sample collection especially for tHb, SO2 and Hct measurement ................. 145
Sample collection especially for glucose/lactate measurement
(cobas b 221<6> system, cobas b 221<5> system only)................................... 146
Sample collection especially for bilirubin measurement
(cobas b 221<2> system, cobas b 221<4> system, cobas b 221<6> system only)
146
Sample containers ....................................................................................................... 147
Syringes .................................................................................................................. 147
Capillary tubes....................................................................................................... 147
Roche MICROSAMPLER PROTECT................................................................ 148
Sample collection container accessories ............................................................ 148
Sample handling.......................................................................................................... 149
Whole blood .......................................................................................................... 149
Serum ..................................................................................................................... 149
Plasma .................................................................................................................... 149
Pleural fluid ........................................................................................................... 150
Interferences....................................................................................................................... 151
Substances with effect in whole blood samples for tHb/SO2................................ 151
Substances with effect in whole blood samples for pH, Hct, ISE ......................... 151
Substances with effect in whole blood samples for MSS........................................ 153
Substances with effect in whole blood samples for Hb derivatives and bilirubin .....
154
Limitations of clinical analysis......................................................................................... 157
General ......................................................................................................................... 157

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Table of contents

Electrolytes................................................................................................................... 157
Blood gas ...................................................................................................................... 157
tHb/SO2 ....................................................................................................................... 158
Metabolites................................................................................................................... 158
Hemoglobin derivatives and bilirubin ..................................................................... 158
pH measurements in pleural fluid ............................................................................ 159
Measuring procedure........................................................................................................ 160
Aspirate from syringe........................................................................................................ 163
Use as default setup ........................................................................................................... 165
Data input........................................................................................................................... 166
Mandatory input ......................................................................................................... 166
Sample distribution..................................................................................................... 167
Result ............................................................................................................................ 168
Last patients ................................................................................................................. 170
POC mode (Point-of-care mode).................................................................................... 171

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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.

U Guidelines and additional information about handling blood samples are provided in
CLSI document M29-A3, "Protection of LaboratoryWorkers 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.

Warning
r The puncture site may never be squeezed. Mixing the blood sample with tissue fluid
WARNING 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.

U 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.
U Refer to CLSI document C46-A, "Blood gas and pH analysis related measurements;
Approved Guideline 2001".

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Preanalytics

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

cobas b 221<5> 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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Preanalytics

Sample containers

Q We recommend using the sample containers offered by Roche.

A BS2 Blood Sampler C Roche MICROSAMPLER PROTECT

B Capillary tubes

Figure 6-1

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.

Warning
r Use only heparinized syringes. Improper use of syringes with liquid heparin will affect
WARNING 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 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.

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Preanalytics

Roche MICROSAMPLER PROTECT

To make arterial sample collection technically easier, the
Roche MICROSAMPLER PROTECT was developed.
The Roche MICROSAMPLER PROTECT consists of one curved plastic capillary
tube (~220 μL) in a plastic container and is ideally suited to atraumatic 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.

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

Sample collection container accessories

The use of the Clot Catcher is recommended to prevent clogging of the sample path
during measurement of critical blood, for example, when sampling blood of
newborns from earlobes or heels.

Clot catcher The Clot Catcher, which is placed on top of the capillary, syringe or
Roche MICROSAMPLER PROTECT, prevents blood clots and tissue particles from
entering the cobas b 221 system.
Using the Clot Catcher is suitable for the capillary mode of the cobas b 221 system
only.

Warning
r The Clot catcher is not suitable for measurements in "Aspiration from syringe" mode.
WARNING
Option

Clot Catcher PRO The Clot Catcher PRO, which is placed on top of a syringe, prevents blood clots and
tissue particles from entering the cobas b 221 system.
Using the Clot Catcher PRO is suitable for the capillary mode of the
cobas b 221 system only.

Warning
r The Clot Catcher PRO is not suitable for measurements in syringe mode and in
WARNING "Aspiration from syringe" mode.

For additional information, refer to the accompanying package insert:

o Clot Catcher
o Clot Catcher PRO.

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Preanalytics

Sample handling

Whole blood
Withdraw whole blood samples using heparinized syringes, capillaries, or the
Roche MICROSAMPLER PROTECT 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.

Warning
r When using capillaries analyze samples for tHb, SO2, Hct, glucose and lactate
WARNING 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

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.

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Preanalytics

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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Interferences

Interferences

Interference study: (1)A study was carried out to evaluate the influence of substances that could possibly

interfere on the measurement of the following parameters:

BG/ISE/MSS and tHb/SO2 and COOX on the cobas b 221 system.
Find the updated list of potential interfering substances for the parameters
BG/ISE/MSS and tHb/SO2 and COOX, measured on the cobas b 221 system, in the
following sections:
U Substances with effect in whole blood samples for tHb/SO2 (p. 151)
U Substances with effect in whole blood samples for pH, Hct, ISE (p. 151)
U Substances with effect in whole blood samples for MSS (p. 153)
U Substances with effect in whole blood samples for Hb derivatives and bilirubin (p. 154)

Substances with effect in whole blood samples for tHb/SO2

Substance Concentration of the Parameter Parameter Effect of the substance

substance concentration
Indocyanin green 5 mg/L tHb 15.60 g/dL 3.83 ± 0.15
Intralipid 10 g/L tHb 15.00 g/dL 2.23 ± 0.17
Methylen blue 30 mg/L SO2 99.90% -25.20 ± 1.47
Lipofundin 10 g/L tHb 14.98 g/dL 1.33 ± 0.25
Table 6-1 Interferences tHb/SO2 module

Substances with effect in whole blood samples for pH, Hct, ISE

Substance Concentration of the Parameter Parameter Effect of the substance

substance concentration
Acetylsalicylic acid (Aspirin) 100 mg/100mL Ca2+ 1.06 mmol/L 0.16 ± 0.01
Bovine Albumin 6% Hct 47.75% 5.36 ± 0.42
4.5% Hct 44.86% 2.16 ± 0.86
Dobesilate 20 mg/100mL K + 5.09 mmol/L 1.06 ± 0.02
Glycolic acid 50 mg/dL Ca2+ 1.09 mmol/L 0.15 ± 0.00
100 mg/dL pH 7.87 -0.94 ± 0.02
Ca2+ 1.09 mmol/L 0.31 ± 0.02
200 mg/100mL pH 7.65 -1.08 ± 0.03
Ca2+ 1.08 mmol/L 0.20 ± 0.01
Potassium chloride 75 mg/100mL K+ 3.90 mmol/L 9.76 ± 0.07
Potassium thiocyanate 23.2 mg/100mL K+ 3.91 mmol/L 2.25 ± 0.02
6.8800 mmol/L Na+ 135.5 mmol/L -4.95 ± 0.33

Table 6-2 Interferences pH, ISE

(1) The study was designed in accordance with the CLSI: "Interference Testing in Clinical Chemistry;
Approved Guideline - Second Edition", EP7-A2, Appendix B and was performed with whole blood.

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Interferences

Substance Concentration of the Parameter Parameter Effect of the substance

substance concentration

Cl- 100.2 mmol/L 5.81 ± 0.54

5.1600 mmol/L Na+ 135.5 mmol/L -3.46 ± 0.29

Cl- 99.3 mmol/L 6.11 ± 0.33

3.4400 mmol/L Na+ 136.3 mmol/L -2.20 ± 0.35

Cl- 99.4 mmol/L 3.98

-0.22/-0.23
Magnesium acetate 15.000 mmol/L Na+ 132.8 mmol/L -3.12 ± 0.51

K+ 4.50 mmol/L -0.27 ± 0.02

Ca2+ 1.18 mmol/L 0.20 ± 0.01

11.250 mmol/L Na+ 134.5 mmol/L -1.5
+0.66/-0.62
K+ 4.56 mmol/L -0.33 ± 0.03

Ca2+ 1.15 mmol/L 0.20 ± 0.02

7.500 mmol/L K+ 4.46 mmol/L -0.11 ± 0.03

Ca2+ 1.17 mmol/L 0.16 ± 0.02

3.750 mmol/L Ca2+ 1.15 mmol/L 0.11 ± 0.02
Magnesium nitrate 128.2 mg/100mL Ca2+ 0.98 mmol/L 0.26 ± 0.01

Cl- 101.76 mmol/L 15.58 ± 1.95

Sodium bromide 37.5 mmol/L Cl- 99.6 mmol/L 73.09 ± 9.21
pH 7.405 -0.034
+0.008/-0.007
28.1 mmol/L Cl - 98.3 mmol/L 59.82 ± 15.2
pH 7.410 +0.040/-0.013
18.8 mmol/L Cl - 100.2 mmol/L 32.45 ±
+7.19/-7.2
pH 7.415 -0.03 ± 0.012
9.4 mmol/L Cl - 101.0 mmol/L 14.94 ± 2.24
7.0 mmol/L Cl- 100.8 mmol/L 3.90
+0.34/-0.35
Sodium citrate, diluted 1000 mg/100mL Ca2+ 1.04 mmol/L -1.05 ± 0.02

Na+ 143.80 mmol/L 60.79 ± 1.36

K+ 3.95 mmol/L -0.58 ± 0.04

Sodium chloride 140 mmol/L Na+ 142.40 mmol/L 37.23 ± 0.45

Cl- 104.13 mmol/L 28.46 ± 4.20

130 mmol/L Na+ 142.26 25.73 ± 0.44

Cl- 103.45 mmol/L 20.90 ± 2.75

120 mmol/L Na+ 142.14 16.29 ± 0.43

Cl- 106.14 mmol/L 13.72 ± 2.04

Substance Concentration of the Parameter Parameter Effect of the substance

substance concentration
67.50 mg/100mL tHb 12.93 g/dL 0.58
+0.03/-0.04
SO2 99.72% -6.68 ± 0.07
O2Hb 95.23% -6.21
+0.08/-0.07
HHb 0.27% 6.39 ± -0.07
Bilirubin 7.57 mg/dL -2.34
+0.11/-0.10
45.00 mg/100mL tHb 13.16 g/dL 0.37 ± 0.03
SO2 99.74% -4.87 ± 0.04
O2Hb 95.29% -4.53 ± 0.07
HHb 0.25% 4.66 ± -0.04
Bilirubin 7.90 mg/dL -1.51 ± 0.08
22.50 mg/100mL SO2 99.73% -2.72 ± 0.05
O2Hb 95.24% -2.49 ± 0.09
HHb 0.26% 2.60
+0.04/-0.05
Bilirubin 7.89 mg/dL -0.89
+0.09/-0.08
11.25 mg/100mL SO2 99.75% -0.11 ± 0.06
HHb 0.25% 0.10
+0.06/-0.05
Indocyanine 5 mg/L HHb 0.02% 0.01 ± 0.02
MetHb 0.63% -0.06 ± 0.06
Intralipid 10 mg/L HHb 0.03% 0.00 ± 0.02
Lipofundin 10 mg/L HHb 0.03% -0.01 ± 0.02
Methylen blue 7.5 mg/L HHb 0.02% 0.00 ± 0.02
MetHb 0.65% -1.09 ± 0.05
30 mg/L HHb 0.02% 0.01 ± 0.02
MetHb 0.77% -4.61 ± 0.20
Bilirubin 20.65 mg/dL -3.02 ± 0.14
4.0 mg/100mL tHb 11.46 g/dL -1.08
+0.07/-0.06
SO2 * *
O2Hb * *
COHb * *
MetHb * *
HHb * *
Bilirubin * *
3.0 mg/100mL tHb 11.40 g/dL -0.84 ± 0.09
SO2 * *
O2Hb * *
Table 6-4 Interferences Hb derivates and bilirubin

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Substance Concentration of the Parameter Parameter Effect of the substance

substance concentration
COHb * *
MetHb * *
HHb * *
Bilirubin * *
2.0 mg/100mL tHb 11.56 g/dL -0.42 ± 0.07
SO2 * *
O2Hb * *
COHb * *
MetHb * *
HHb * *
Bilirubin * *
1.0 mg/100mL SO2 99.70% 0.00 ± 0.01
O2Hb 96.69% 0.37 ± 0.06
COHb 2.57% -0.02
+0.06/-0.05
MetHb 0.45% -0.35
+0.03/-0.04
HHb 0.29% 0.00 ± 0.01
Bilirubin * *
Patent blue 1.0 mg/100mL MetHb 0.58% 2.65 ± 0.03
Bilirubin 15.98 mg/dL 3.81 ± 0.11
0.75 mg/100mL MetHb 0.57% 1.95 ± 0.03
Bilirubin 16.23 mg/dL 2.66
+0.13/-0.14
0.50 mg/100mL MetHb 0.47% 1.21
+0.04/-0.03
Bilirubin 15.95 mg/dL 1.89
+0.06/-0.07
0.25 mg/100mL MetHb 0.47% 0.61
+0.07/-0.06
Bilirubin 16.24 mg/dL 0.93
+0.10/-0.09
Propofol 2 μl/mL HHb 0.03% 0.00 ± 0.03
Table 6-4 Interferences Hb derivates and bilirubin

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Limitations of clinical analysis

The determined performance data can be influenced by known and unknown factors
as described below.
U For details, see section Interferences (p. 151), tHb/SO2 (p. 158) and Metabolites (p. 158).

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.

Warning
r Ensure that the selected sample type matches the sample to be measured. If the
WARNING 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 preferred 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.(1)
U see section Preanalytics (p. 145)

(1) 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).

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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.
U see section Preanalytics (p. 145)

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.
U Detailed information about the correct treatment of samples are listed in the
section Preanalytics (p. 145).

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.
U summarized in section Substances with effect in whole blood samples for MSS (p. 153).
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
U summarized in section Substances with effect in whole blood samples for Hb derivatives
and bilirubin (p. 154).

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Limitations of clinical analysis

pH measurements in pleural fluid

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

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Measuring procedure

Measuring procedure

Warning
r QC measurements must be performed in their entirety (i.e., all three QC levels must be
WARNING 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.
U see Reference Manual chapter Software modes, section Setup
It is possible to measure samples from syringes (without needles), ampoules and
capillaries.

P Syringe mode
Warning
r Improper heparinization of syringes with liquid heparin may cause erroneous results.
WARNING 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 6-2

Q 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.

U For details, see Figure 6-3 (p. 161)

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Figure 6-3

2 The following screen appears:

Figure 6-4

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.
S

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P Capillary measurement
Caution
r Only glass capillary tubes with heat-polished ends or the plastic capillary tubes offered
CAUTION by Roche may be used in order to prevent damage to the instrument.
U see Capillary tubes (p. 147) in the section Sample containers (p. 147)

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

Figure 6-5

2 Press the [Aspirate sample] button.

U see Figure 6-4 (p. 161)
3 Detach the capillaries or the Roche MICROSAMPLER PROTECT after the
message "Remove sample container" appears.
4 The measurement starts.
S

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Aspirate from syringe

Aspirate from syringe

This option is activated in the [Setup] mode.

Caution
r 1mL syringes cannot be used for the software mode "Aspirate from syringe".
CAUTION
Q A minimum fill height of 15 mm is required.

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.

Figure 6-6

P
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 6-7

3 Press the [Aspirate sample] button.

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Aspirate from syringe

4 The sample is aspirated from the syringe.

5 Detach the syringe after the message "Remove sample container" appears.
6 The measurement starts.
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Use as default setup

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

P
1 Press [Activate aspirate from syringe].
2 Activate [Use as default setup].

Figure 6-8

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.
S

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Data input

Data input

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

entered.

Figure 6-9

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".

Q 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.

Warning
r The user must carry out a plausibility check for all barcode data read in and displayed
WARNING 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.

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

necessary.

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Data input

Sample distribution

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

Figure 6-10

Figure 6-11

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Data input

Result

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

Figure 6-12

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

Q If a connection to an ASTM host and the function "Send immediately" ([Setup] >
[Interfaces] > [ASTM]) is activated, the input values must not be changed anymore after
the measurement is finished. If changed after sent to the LIS system an inconsistency
(worst case data - patient mismatch) between measurement database and LIS database
will occur.

U 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.

[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.

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Data input

Figure 6-13

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.

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

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Data input

Figure 6-14

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

Last patients

QC warning) if MSS sensor cannot be wetted (using standby solution):
o For over 25 minutes during the first 24 hours of the sensor’s lifetime
o For over 80 minutes during the remaining sensor lifetime
This is necessary due to uncertain drift of the sensor signal in such cases.
U see No. 30006, Undefined sensor status, System warnings (p. 304) ,
Caution
r If the MSS sensor wetting is not applied for the above defined period of time, the
CAUTION parameters Glu and Lac might be sensitive to the other enzyme. Therefore, a full
QC measurement (level 1, level 2, level 3) will become necessary to ensure sensor
accuracy.
The system will automatically lock AUTO-TROL materials, if no AUTO-TROL materials
are installed, the system will lock COMBITROL.

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General QC concept

General QC concept

Roche always strives to ensure the highest quality standards for its products. This
quality awareness is the result of a sense of responsibility toward the customer and
the well-being of the patient.
The quality control is an important element of this claim. Aqueous blood
gas/electrolyte QC materials, such as COMBITROL TS+, AUTO-TROL TS+, etc., are
offered to ensure that the cobas b 221 system provides measurements of high quality
to protect customers or its patients.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (1 = low, 2 = normal, 3 = high) after each electrode exchange, after
each exchange of solutions and packs and after startup of the instrument (switched
off more than 24 hours).
Additionally complete a quality control test on one level between two automatic 2P
calibrations. The levels have to be alternated (1 = low, 2 = normal, 3 = high).
For example (2P calibration interval: 12 hours):

24 hours

2P-Cal. Level 1 2P-Cal. Level 2 2P-Cal. Level 3 2P-Cal. Level 1

Figure 7-1

Q The automatic system calibration includes a complete 2P calibration.

Complete at least two quality control tests on different levels once daily or more often
in accordance with local regulations.

Q Run quality control tests ideally prior to sample measurements.

A quality control program includes the analysis of sample materials with known
ranges of expected values and the comparison of these values with analyzer results.
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)

Color 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).

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General QC concept

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
U see section Important information concerning the analysis of QC measurement results
(p. 178).

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.
U see section Important information concerning the analysis of QC measurement results
(p. 178).

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Important information concerning the analysis of QC measurement results

Important information concerning the analysis of QC

measurement results

Warning
r Ensure, that "Multirules" rule 1 and 2 are activated and the QC consequence "QC lock"
WARNING was assigned to the parameters.

U see section Multirules (p. 199)

U see section QC consequences (p. 201)
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.
U see section Remove the QC lock (p. 202)
o Measured value is larger than target value ± 2SD, but smaller than target value
± 3 SD
Consequence: The parameter is flagged with the information “warning” on the
printout. However, the parameter will not be marked as QC warned in the
“Ready” screen.
U see Quality control - general (p. 175)
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.
U see section QC measurements (p. 232)
The analysis can be automated by activating additional multirules.
U see section Multirules (p. 199)
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.

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

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Material setup

Material setup

Q 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.

Q 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 7-2

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.

Figure 7-3

Press [Ranges] and read in the additional barcodes for the target values.

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Material setup

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 assignment – AutoQC materials

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 7-4

Figure 7-5

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

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

P Inserting the AutoQC mats

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

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Material assignment – AutoQC materials

Figure 7-6

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 7-7 AutoQC-Mat

4 Place the mat in the defined position of the ampoule block so that the ampoules
are no longer visible.
5 Press [Refill].
The following question appears:

Figure 7-8

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Material assignment – AutoQC materials

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 7-9

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).

Figure 7-10

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.
S

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QC timing

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 7-11

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
the defined calibration intervals. Small red-colored point - System calibration, small
green-colored triangle - 2P calibration.

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Setting start time(s)

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.

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Change lot (applies only to AutoQC measurements)

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.

P Material setting/Material assignment – Follow-up material

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

1 Press the following buttons:

h Setup > QC Material > QC Material
2 Read in the material code from the package insert using the barcode scanner or
press the [New] button and manually enter the information.
3 Press the [Ranges] button.
4 Read in the other barcodes for the target values.
5 Select the material/level combination and press [Mat].
6 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]).
7 Press [Set] and the selected material/level combination will be assigned to a mat
(A-F).

Press this button to store the assignment.

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

9 Pull out the AutoQC drawer.
10 Take a full mat of the follow-up material from the package.
11 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.
12 Place the mat in the previously defined position (A-F) of the ampoule block.
13 Press [Refill].
14 Close the AutoQC drawer.

Q 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.

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Change lot (applies only to AutoQC measurements)

15 Next, press the following button:

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

Q 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.

17 In the "New lot number" window, select the lot of the replacement material.
18 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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Control - on board time

Control - on board time

h Setup > QC material > Control - on board time

Activating this function allows you to monitor the on board time of new QC material
or QC material already in use.
When installing expired QC material, a warning is output during the installation
process. With each QC measurement a message is displayed on the QC report and in
the QC database.
Depending on the material status, the following notes are displayed on the QC report
and in the QC database:

Material status Displayed message

QC material expired "Material expired"
On board time exceeded "On board time exceeded"
Table 7-1

Q Expired QC material is not locked. QC measurements continue to be possible.

P QC setup wizard
1 Starting with the top level of the analyzer mode:
This chapter describes the software supported setup of QC material step by step.

Q 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"

U see Reference Manual chapter 3 Setup, section Security.

2 Open the AQC drawer.

Figure 7-12

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Control - on board time

3 Press [Yes]. Following screen appears:

Figure 7-13

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

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Scanning the material code

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
U see Change lot (applies only to AutoQC measurements) (p. 186)
o Do not carry out lot change

Allows you to review or discard your entries.

Exits the QC setup wizard.

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Scanning ranges

Scanning ranges

New QC material

The following screen appears:

Figure 7-14

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.

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

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Checking for AutoQC compatibility

Checking for AutoQC compatibility

After all ranges are set, the QC material is checked for AutoQC compatibility.
AutoQC compatible materials:
o AUTO-TROL TS+ (only for system 1,3 and 5)
o AUTO-TROL PLUS B
The following QC materials do not meet these requirements:
o COMBITROL TS
o COMBITROL TS+ (only for system 1,3 and 5)
o COMBITROL PLUS
o COMBITROL PLUS B

Figure 7-15

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.

U See Figure 7-14 (p. 191)
Table 7-2

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

AutoQC module is installed.

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Checking for AutoQC compatibility

P Assigning the mats

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

Figure 7-16

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

Figure 7-17

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

Q You cannot change the number of ampoules in the QC setup wizard.

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Checking for AutoQC compatibility

P AQC timing
1 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.

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

Figure 7-18

All previously defined AQC times are shown in the list.

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

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

Figure 7-19

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

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Checking for AutoQC compatibility

Figure 7-20

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

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.
U see section Checking for AutoQC compatibility (p. 192)

Q Other options for starting the QC setup wizard are:

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

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QC measurement

QC measurement

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

Figure 7-21

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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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 7-22 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.
U For details about the "Database" see section Data manager (p. 229) and/or Reference
Manual, chapter Softwaremodi.
S

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AutoQC measurement

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(1) and their

interpretation for blood gas analysis(2). 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.

Q 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 7-23

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".

Q The activation of range 2SD automatically deactivates all other rules (rules 1-6).
If only Rule 1 is activated, in case of violation, this results in a warning only; the parameter
is not locked in the rest of the sequence.

(1) James O.Westgard, et al: A Multi-Rule Shewhart Chart for Quality Control in Clinical Chemistry.
Clinical Chemistry, Vol. 27, No.3, 1981
(2) 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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Overview of the Multirules

Overview of the Multirules

Serie time between two 2-point calibrations

NT number of individual measurements of all levels (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
 standard deviation

Rule Description
1. 12 QC measurement value (m) is outside
x ± 2
2. 13s QC measurement value (m) is outside
x ± 3
3. (2 von 3)2s Two of three QC measurement values are outside x ± 2
Observation time period: 1 series (repeatability)
NT = 3
4. 22s 2 QC measurement values (m) are outside x ± 2
Observation time period: 2 series
NL  2
5. 61s 6 QC measurement values (m) are outside x ± 1
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 7-3 Multirules

Q 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 7-24

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 parameter is in the "QC Warning" status.
QC lock: the parameter will be blocked if one of the adjusted rules is broken.
The parameter will be identified accordingly in the Ready screen.
A status report appears after pressing the parameter button.

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Remove the QC lock

Remove the QC lock

QC warning

Proper execution of a QC measurement using the same material/level combination

removes the warning.

QC lock

Automatic correction
Using the "QC for ready" function, the required AutoQC measurements are carried
out with the corresponding material/level combination, which can remove this lock.
Proper execution of a QC measurement using the same material/level combination
removes the block.

Manual correction

Warning
r A manual correction is only allowed if the same material/level combination is no longer
WARNING available.
r In this case, repeat the QC measurement with a new material/level combination of a
different lot and analyze it as described under "Important information concerning the
analysis of QC measurement results".

Press the following buttons to unlock the QC lock:

h Setup > Parameter > Miscellaneous settings > Remove QC lock
To remove a QC lock, the correct parameter must be selected.

Q A calibration, changing electrodes and/or changing an MSS cassette do not remove a QC

lock.

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Exchange the electrode

Exchange the electrode

U see section Replacement of the electrodes (p. 270)

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QC for Ready (with AutoQC module)

QC for Ready (with AutoQC module)

Parameters will be blocked if one of the adjusted rules is broken and identified
accordingly in the Ready screen.
The function "QC for Ready" generates a list of the required manual QC
measurements (material/level combination) that can remove this lock again.
Proceeding from the uppermost level of the analyzer mode, press the following
buttons:
QC measurement

Figure 7-25

P
1 Press [QC for Ready]. When all parameters are ready for measurement, the
AutoQC measurement is started automatically.
2 If the parameters are not all ready for measuring, the following screen appears:

Figure 7-26

3 Here, a list is given of all the parameters for which a measurement "QC for Ready"
is not possible, and the reason why. If required, print the list [Print], remedy the
cause and repeat the procedure.

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QC for Ready (with AutoQC module)

4 Press [Perform QC for Ready]. The AutoQC measurement is started for all
parameters ready for measurement.
5 With the [Interrupt QC for Ready] key, the procedure can be interrupted.
6 The measurement results are printed out and stored automatically in the QC
database.
S

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QC for Ready (without AutoQC module)

QC for Ready (without AutoQC module)

P
1 Proceeding from the uppermost level of the analyzer mode, press the following
buttons:
h QC measurement

Figure 7-27

2 Press [QC measurement for Ready].

3 If the parameters are not all ready for measurement, the following screen appears:

Figure 7-28

4 Here, all the parameters are listed for which a measurement "QC measurement
for Ready" is not possible, and the reason why. If required, print the list [Print],
remedy the cause and repeat the procedure.

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QC for Ready (without AutoQC module)

5 Press the button [Perform QC for Ready]. The following screen appears:

Figure 7-29

6 Here, the respective material/level combinations are listed that can remove this
lock again.
7 Print the list [Print] and perform a manual QC measurement with the listed QC
materials.
U see section QC measurement (p. 196)
S

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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.

P 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.
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.

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5 Repeat the QC measurement (with same material/level combination)

If the error persists, contact customer service.
S

P 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.
5 If the problem cannot be solved successfully, the Customer Service must be
notified.

Q Note:
For optimal display of the QC results on the screen and the printout, the QC values are
rounded. However, unrounded values are used for evaluating the individual QC results.
This can cause a "nOK" evaluation of a QC result, even if the QC result shown lies
within the target range.
This procedure is necessitated by the software and does not result in an increased
patient risk.

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Table of contents

Calibration 8

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

In this chapter Chapter 8

Calibration - general ......................................................................................................... 213
Automatic calibrations...................................................................................................... 213
System calibration ....................................................................................................... 213
2P calibration (2P cal) ................................................................................................ 213
1P calibration (1P cal) including O2 ........................................................................ 213
Recalibration - without O2 ........................................................................................ 214
User-activated calibrations............................................................................................... 214
Display of parameters during calibration....................................................................... 216

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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 and
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

Q 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.

U see Reference Manual, chapter Software modes, section Setup.

2P calibration (2P cal)

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

1P calibration (1P cal) including O2

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

Warning
r USA: 30 min only
WARNING (adjustable: [Setup] > [Protected setup] - this area is password protected and is
accessible only to authorized personnel or customer service representative).

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User-activated calibrations

Recalibration - without O2

After every measurement.

User-activated calibrations

Activation in analyzer mode:

System > Calibration

A Example: Instrument with COOX and MSS module

Figure 8-1 User-activated calibrations

Q 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.
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

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User-activated calibrations

o Mixing system:
Calibration of the conductivity system
o COOX calibration (for instruments with COOX module only)
U For a detailed description of how to do this, see COOX calibration (for instrument
versions with COOX module only) (p. 253).
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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Display of parameters during calibration

Display of parameters during calibration

Figure 8-2 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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Table of contents

Software modes 9

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 ................................................................................................. 219
User interface ..................................................................................................................... 219
Parameters/icons ............................................................................................................... 221
Display on the Ready screen (analyzer mode) ........................................................ 221
Notation of the measurement, input, and calculation values................................ 221
Buttons.......................................................................................................................... 224
Analyzer mode................................................................................................................... 226
"Ready" screen ............................................................................................................. 226
System........................................................................................................................... 227
Quick access................................................................................................................. 227
QC measurement ........................................................................................................ 227
Setup.................................................................................................................................... 228
Data manager..................................................................................................................... 229
General data manager functions ............................................................................... 229
Patients ......................................................................................................................... 231
Measurements.............................................................................................................. 231
Calibrations.................................................................................................................. 232
QC measurements....................................................................................................... 232
Instrument ................................................................................................................... 233
Utilities ......................................................................................................................... 233
Backup/Restore ..................................................................................................... 233
Protected DB functions........................................................................................ 234
Info ...................................................................................................................................... 235
Help............................................................................................................................... 235
Fill level......................................................................................................................... 235
QC status ...................................................................................................................... 236
Video sequences .......................................................................................................... 236
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Table of contents

List of all activities....................................................................................................... 236

List of all warnings ...................................................................................................... 238
AQC status ................................................................................................................... 238
Versions ........................................................................................................................ 239
Miscellaneous reports................................................................................................. 239
Parameter report ................................................................................................... 239
Sensor report ......................................................................................................... 240
Status report........................................................................................................... 240
Messages ....................................................................................................................... 240
Protected information ................................................................................................ 241

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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 H Current time

B Status line I Direct call-up of the video sequences
offered
C AutoQC act./deact. J Required sample volume (display varies
according to activated/deactivated modules)
D Network connection act./deact. K Software modes (Info, setup, analyzer,
database)
E Pending maintenance L Error/instruction window
F Type and time of next calibration M "active"
G Current date

Figure 9-1 "Ready" screen

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User interface

For example: "Screen sharing" (a remote monitoring and remote maintenance software is active)

A "Screen sharing" (a remote monitoring and

remote maintenance software is active)

Figure 9-2

For example: User-defined parameter groups

Setup > Parameter > User-defined parameter groups
This function helps to define three parameter groups.
U For a detailed description, see the Reference Manual, chapter 3 Setup, section User defined
parameter groups.

Figure 9-3

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Parameters/icons

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)(1)

Parameter not ready (due to QC lock)(1)

Parameter not ready due to remote lock

Parameter permanently deactivated (under "Setup")

(1) A status report appears after pressing the parameter button.

Notation of the measurement, input, and calculation values

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

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Parameters/icons

tHb Total hemoglobin concentration

O2Hb Oxyhemoglobin
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
Hct(c) Hct calculated from tHb

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Parameters/icons

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

RIt Respiratory index at patient's temperature

AaDO2t Alveolar-arterial oxygen partial pressure at patient's temperature

a/AO2t Alveolar-arterial oxygen partial pressure ratio at patient's temperature

pHt pH at patient's temperature

PCO2t PCO2 at patient's temperature

PO2t PO2 at patient's temperature

H+t 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
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
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Parameters/icons

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

Move left to start/right to end

Move one entry up/down

Move one page down/up

Move to bottom/top

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Parameters/icons

Example for switch button - ON/OFF

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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 9-4

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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Analyzer mode

System

The following main menus are available:

Figure 9-5

U 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 9-6

U For a detailed description, see the Reference Manual, Chapter Software modes, section
Analyzer > Quick access

QC measurement

This function helps start a quality control measurement.

U For more detailed information, see Quality control (p. 173).

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Setup

Setup

Use this function to make the following settings:

Figure 9-7

U For a detailed description, see the Reference Manual, chapter Software modes, section
Analyzer > Setup

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Data manager

Data manager

Use this function to retrieve the following data:

Figure 9-8

U 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 data records using defined search criteria.

Sort - this function allows to sort the recordings.

Marker - the current data record is permanently marked and now has a yellow background to
make it more easily visible.

Mark range - use this function to mark a range.

The marking criterion corresponds to the current sort criterion of the data records.
All data sets are marked only if the "From" input field is empty and "zz" is specified in the "To"
field.

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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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.

Q 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.

Copy from disk - the archive(s) saved on disk are copied directly back to the archive
overview.

Restore archive - the marked dataset(s) are reinserted into the current database.

Backup now - a full databank backup is started.

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Patients

Patient data that were entered are listed depending on the definition of the display
([Setup] > [Display & reports] > [Patient database] > [Patient database overview]).
Use the buttons "Page up/down" or "Up/down" to select an entry and press the
[Details] button. All available information about the selected entry are displayed.
U For a detailed description, see the Reference Manual, chapter Software modes, section
Data manager.

Measurements

Figure 9-9

Measurements that were carried out are listed depending on the definition of the
display ([Setup] > [Display & reports] > [Measurement] > [Sample database
overview]).
Use the buttons "Page up/down" or "Up/down" to select an entry and press the
[Details] button. All available information about the selected entry are displayed.

Q An edit of the specimen ID in the measurement database causes to an automatic delete of

all patient relevant information. There is no specimen query started in case of a change of
the specimen ID in the database.
In case the patient relevant data is known and needed for patient trending, it is necessary
to enter additionally the corresponding patient ID. After the entry of the patient ID the
patient demographic query is started automatically.
Because of editing the specimen ID or patient ID, the changed dataset have to be resent to
the LIS/HIS manually.
Important:
If the specimen ID is not unique in the LIS, a mismatch of patient related data in the LIS is
very likely and it could happen that a measurement is assigned to the wrong patient in the
LIS.
Ensure a unique ID in the hospital environment.

U For a detailed description, see the Reference Manual, chapter Software modes, section
Data manager.

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Calibrations

Figure 9-10

Calibrations that were carried out are listed depending on the definition of the
display ([Setup] > [Display & reports] > [Calibration] > [Calibration database
overview]).
Use the buttons "Page up/down" or "Up/down" to select an entry and press the
[Details] button. All available information about the selected entries are displayed.

QC measurements

Figure 9-11

QC measurements that were carried out are listed depending on the definition of the
display ([Setup] > [Display & reports] > [QC measurement] > [QC database
overview]).
Use the buttons "Page up/down" or "Up/down" to select an entry and press the
[Details] button. All available information about the selected entry are displayed.

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Instrument

Figure 9-12

Stored instrument data are listed depending on the definition of the display
([Setup] > [Display & reports] > [Instrument database] > [Instrument database
overview]).
Use the buttons "Page up/down" or "Up/down" to select an entry and press the
[Details] button. All information about the selected entry are displayed.

Utilities

Backup/Restore
Use this function to perform a data backup.

Figure 9-13

U For a detailed description, see the Reference Manual, chapter Software modes, section
Data manager.

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Protected DB functions
This area is password-protected and only accessible to authorized personnel or
customer service.

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Info

Info

The following information can be displayed:

Figure 9-14

Help

Use this function to retrieve online help information.

Fill level

Figure 9-15

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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Info

QC status

Figure 9-16

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

Q If this function is not available, contact customer service.

U see Figure 9-14 (p. 235)

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.

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Info

A Warning window for pending maintenance, rotating display

Figure 9-17

Q All pending maintenance tasks are shown in a rotating display.

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.

U See Figure 9-17 (p. 237).

Q 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.

Q 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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Info

List of all warnings

Figure 9-18

Here, all the module stops and warnings are listed with their code, or it can be found
in Troubleshooting (p. 291), using the respective error code (ID)

[Action info] Further information is displayed on the errors indicated.

AQC status

Figure 9-19

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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Versions

Figure 9-20

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 9-21

Displays the status of the electrodes.

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Sensor report

Figure 9-22

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.

Messages

All messages sent by cobas bge link software are displayed here.
The "Message" note is displayed in the error/instruction window of the screen (upper
right). This message continues to be displayed as long as there are messages in the
message buffer.
Press the [Show message] button to view the entire message.
Press the [Delete message] button to delete the selected message.

Figure 9-23

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Protected information

This area is password-protected and only accessible to authorized personnel or

customer service.

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10 Maintenance................................................................................................................................... 245

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Table of contents

Maintenance 10

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 ...................................................................................................... 247
Decontamination............................................................................................................... 247
Input unit ..................................................................................................................... 247
Touch Screen................................................................................................................ 248
Surfaces of the instrument ......................................................................................... 248
Tubing paths ................................................................................................................ 248
Recommended disinfectants ..................................................................................... 248
Daily .................................................................................................................................... 249
Checking fill level........................................................................................................ 249
Checking printer paper .............................................................................................. 249
Weekly................................................................................................................................. 250
Cleaning fill port and sample drip tray .................................................................... 250
Cleaning the touch screen.......................................................................................... 250
Quarterly ............................................................................................................................ 252
Cleaning the T&D disk............................................................................................... 252
Changing the air filter ................................................................................................ 253
COOX calibration (for instrument versions with COOX module only)............. 253
Sample-dependent maintenance procedures................................................................. 256
Exchange of solutions and packs............................................................................... 256
S1 Rinse Solution/S2 Fluid Pack/S3 Fluid Pack ................................................ 256
Waste water .................................................................................................................. 259
1. Empty the W Waste Container ....................................................................... 259
2. Using the empty S1 rinse solution bottle as W waste container ................. 261
Installing the waste water container ................................................................... 261
Cleaning the modules and tubing paths................................................................... 262
Module cleaning.................................................................................................... 262
Tubing paths .......................................................................................................... 263
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Unscheduled ...................................................................................................................... 265

Exchanging the fill port.............................................................................................. 265
Exchanging the peristaltic pump tubes .................................................................... 266
Cleaning the bottle compartment ............................................................................. 268
Replacing printer paper.............................................................................................. 268
Replacement of the electrodes................................................................................... 270
Setting up the Maintenance schedule....................................................................... 272
Changing the reference electrode ............................................................................. 278
Changing the MSS cassette (cobas b 221<5> system and cobas b 221<6> system
only) .............................................................................................................................. 280
Cleaning the measuring chambers ........................................................................... 282
Surfaces......................................................................................................................... 283
Changing of AutoQC mats ........................................................................................ 283
Additional maintenance procedures............................................................................... 286
Yearly service ............................................................................................................... 286
Replacement every three years .................................................................................. 286

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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.

Caution
r Use only liquid disinfectant such as protein remover (Roche deproteinizer) or an
CAUTION alcohol-based (about 70%) surface disinfectant.
r Do not spray disinfectant directly onto the instrument because this could cause
malfunctions in the electronics.
r Do not use any type of bleaching agent. Exception: Roche Deproteinizer

Warning
r Do not attempt to decontaminate any part of the instrument before shutting it down
WARNING and unplugging it from the power source.
r 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.
r 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 (including fill port) and the sample drip
tray
o Touch screen
o Surfaces of the instrument
o Tubing paths

Input unit

U see Cleaning fill port and sample drip tray (p. 250)
U see Quarterly (p. 252)
U see Exchanging the fill port (p. 265)

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Touch Screen

U see Cleaning the touch screen (p. 250)

Surfaces of the instrument

U see Surfaces (p. 283)

Tubing paths

U see Cleaning the modules and tubing paths (p. 262)

Recommended disinfectants

Caution
r Do not use any type of bleaching agent. Exception: Roche Deproteinizer
CAUTION
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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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.
U see section Exchange of solutions and packs (p. 256) or section Waste water (p. 259).

Checking printer paper

Check daily to be sure that sufficient paper is available and exchange it, if necessary.

Q The printer paper is heat sensitive on one side only. Please make sure that you insert the
paper roll correctly.

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Weekly

Weekly

Cleaning fill port and sample drip tray

Handle these parts with care — danger of injury. Always wear gloves.
Danger of infection.

P Cleaning fill port and sample drip tray

1 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 10-1 Input unit

2 Pull out the sample drip tray and clean it with a cloth moistened with disinfectant.
3 Reinsert the sample drip tray.
4 Clean the fill port with a soft cotton swab moistened with disinfectant.
S

Cleaning the touch screen

P Cleaning the touch screen

1 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.

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Caution
r Clean only with a moist cloth (for example, one that is soaked with disinfectant). Do
CAUTION not use water and sprays.

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Quarterly

Quarterly

Cleaning the T&D disk

P Cleaning the T&D disk

1 Activate the following function, starting with the top level of the analyzer mode:
h System > Wash & cleaning > Clean input unit
2 Pull out the sample drip tray and clean it with a cloth moistened with disinfectant.
U see Figure 10-1 Input unit (p. 250)
3 Remove the T&D cover.
4 Clean the fill port with a soft cotton swab moistened with disinfectant.
5 Rotate the fill port 90° downward and remove it.

A Needle

Figure 10-2 T&D disk

6 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.
7 Remove the T&D disk.
8 Clean and decontaminate the front and back of the T&D disk.

Caution
r Do not use alcohol for cleaning the T&D disk.
CAUTION
9 Re-install the disk in reverse order.
10 Re-insert the fill port.
11 Close the T&D cover.
12 Insert the sample drip tray.
S

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Changing the air filter

P Changing the air filter

1 Pull out the air filter using the box tongue (see below).

Figure 10-3 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.
U see Figure 10-3 Air filter (p. 253)

Q 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)

Q 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.

P Performing a COOX calibration

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

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Quarterly

6 To start the calibration, press [Start].

The following screen appears:

Figure 10-4

7 "tHb (target value) [g/dL]": enter the desired target value using the keyboard.

Q Take the target value for the tHb calibrator from the label of the tHb calibrator
recommended by Roche.

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 set point.
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 10-5 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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Quarterly

Warning
r If the cuvette has been replaced, no calibration value appears, just the comment
WARNING "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 set point 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.
S

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Sample-dependent maintenance procedures

Exchange of solutions and packs

Warning
r In order to ensure the quality of the measurement results, complete a quality control
WARNING test on 3 levels (1 = low, 2 = normal, 3 = 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 10-6 Solutions and packs

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.

Warning
r The use of an expired fluid pack can lead to calibration errors.
WARNING r Insert a new pack which has not expired.
r Never use expired bottles/packs.

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P 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 10-7

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).

Warning
r Remove packs’ rubber sealings.
WARNING
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 (1 = low, 2 = normal, 3 = high) must
be performed after every exchange of solutions and packs.
8 Make sure that the results are in line with the target values.
U see Quality control (p. 173)

Q 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.
S

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P Procedure
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 10-8 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 10-9 Deaerate bottle S1

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Waste water

P Exchange the waste water container (W Waste Container)

1 Open the bottle compartment cover.
The bottle exchange image appears on the display.

Figure 10-10

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).

1. Empty the W Waste Container

Always wear gloves. Danger of infection.

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P Emptying the W Waste Container

1 Place the bottle tool on the screw cap.

A Bottle tool B Screw cap with placed bottle tool

Figure 10-11 Bottle tool

2 Open the screw cap by pressing the two grips together and rotate them counter-
clockwise.

Figure 10-12 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 10-13 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.

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 approximately 5 uses.
Dispose of the waste water container according to applicable local codes and regulations
(hazardous waste).

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2. Using the empty S1 rinse solution bottle as W waste container

o Remove the sticker from the empty bottle of S1 rinse solution.

Q This sticker may not be reused – discard immediately.

D
B C
A

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 10-14 Sticker

Installing the waste water container

P 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.
S

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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 10-1

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.
U 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 10-15

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P BG-/ISE-/ COOX- or tHb/SO2 module:

Q 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.
S

P MSS module (cobas b 221<5> system and cobas b 221<6> system

only):
1 This cleaning should be performed with every exchange of the cassette, but not
more than once per month (e.g. obstruction).
2 Activate the MSS module and press [Start external cleaning].
3 The external cleaning agent is inserted like a sample (syringe or capillary) via the
fill port.
4 Insert a new MSS cassette using the correct procedure.
U see Changing the MSS cassette (cobas b 221<5> system and cobas b 221<6> system
only) (p. 280)

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.

Warning
r In order to ensure the quality of the measurement results, complete a quality control
WARNING test on 3 levels (1 = low, 2 = normal, 3 = 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.

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Q The decontamination procedure must be carried out completely and may not be
interrupted.
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].

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

symbol is displayed.

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Unscheduled

Unscheduled

Exchanging the fill port

Dispose of the used fill port in accordance with local regulations (hazardous waste).

P Exchanging the fill port

1 Activate the following function, starting with the top level of the analyzer mode:
h System > Wash & cleaning > Clean input unit
2 Pull out the sample drip tray and clean it with a cloth moistened with disinfectant.
3 Open the T&D cover.
4 Rotate fill port 90° downward and carefully remove it from the needle.

A Needle

Figure 10-16

5 Insert new fill port.

Caution
r Do not bend the needle.
CAUTION
6 Close the T&D cover.
7 Reinsert the sample drip tray.
8 Close the bottle compartment cover.
S

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Exchanging the peristaltic pump tubes

P Exchanging the peristaltic pump tubes

1 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

A B C
A Main pump C MSS input pump
B MSS output pump

Figure 10-17 Peristaltic pump

2 Select the appropriate pump tube to be changed from the list and press [Perform].
3 Remove the top cover.
4 Open the peristaltic pump's clear plastic cover (tension lever) (see below/A).

A Tension lever
B Pump head
C Linear bracket

Figure 10-18 Peristaltic pump

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

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6 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 10-19 Peristaltic pump

7 Check if the five rollers are easily moveable.

In case of malfunction contact customer service.
8 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).
9 Close the clear plastic cover (tension lever). The tubing holder is then pressed into
the sealer.
10 Close the top cover.

The tubes may drip a little after being disconnected.

Remove excess fluids with a clean, absorbent cloth.

Q The peristaltic pump tubes are also replaced during the annual service.

U see section Additional maintenance procedures (p. 286)

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Cleaning the bottle compartment

P Cleaning the bottle compartment

1 Open the bottle compartment cover.
The bottle exchange image appears on the display.

Figure 10-20

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.
U see Exchange of solutions and packs (p. 256)
5 Close the docking mechanism and the bottle compartment cover.
S

Replacing printer paper

P Replacing the printer paper

1 Open the printer cover.

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

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 10-21 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 10-22 Place printer paper- without take-up unit

Figure 10-23 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.
S

P 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.
U see Figure 10-23 Place printer paper - with take-up unit (optional) (p. 269)

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3 Close printer cover.

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

Replacement of the electrodes

P Replacing of the electrodes

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).

Warning
r The electrode must be installed in the instrument no later than the imprinted
WARNING "Install before" date.
U see Conventions used in this manual (p. 7) > Other symbols (p. 10)
r In order to ensure the quality of the measurement results, complete a quality
control test on 3 levels (1 = low, 2 = normal, 3 = high) after each electrode
exchange.

Q In each case, open only the relevant measuring chamber. Keep the bottle compartment
cover closed.

The following screen appears:

Figure 10-24

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).

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4 If necessary, clean the measuring chamber with a cloth moistened with

disinfectant (e.g. disinfectant containing 70% alcohol).

Q 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.

Caution
r If an electrode is replaced by a dummy electrode, it must be immediately
CAUTION 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 10-25 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.

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12 Read the next actions, their duration and the sensor data.

Figure 10-26

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 (1 = low, 2 = normal, 3 = high).
16 Make sure that the results are in line with the target values.
U see Quality control (p. 173)
S

Setting up the Maintenance schedule

The Maintenance schedule is used to alert users when the reference electrode or other
electrodes, e.g. ISE, and MSS (Urea) must be replaced.

Warning
r The reference electrode must be replaced after 52 weeks of in-use time.
WARNING

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P Set up a new Maintenance schedule

1 Press the following buttons:
h Setup > Times & interval > Maintenance schedule

Figure 10-27 Maintenance schedule

2 Choose the New button.

Figure 10-28 New schedule

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3 Fill out the schedule fields using the button. The reference electrode has
an in-use time of 52 weeks. For the Interval field, select one year.

Figure 10-29 Fill out the schedule fields

4 Choose the button to save the setup.

5 Confirm schedule setup.

Figure 10-30 Confirm schedule setup

Q Note
Use the Maintenance schedule to set up an alert for the ISE and MSS (Urea) reference
electrodes.

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P Edit an existing Maintenance schedule

1 Press the following buttons:
h Setup > Times & interval > Maintenance schedule

Figure 10-31 Maintenance schedule

2 Select the schedule for editing and choose the Edit button.

Figure 10-32 Select schedule

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3 Edit the schedule fields using the button. The reference electrode has an
in-use time of 52 weeks. For the Interval field, select one year.

Figure 10-33 Edit schedule fields

4 Choose the button to save the setup.

5 Confirm the schedule setup.

Figure 10-34 Confirm schedule setup

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P Delete a Maintenance schedule

1 Press the following buttons:
h Setup > Times & interval > Maintenance schedule

Figure 10-35 Maintenance schedule

2 Select the schedule for deletion and choose the Delete button.

Figure 10-36 Select schedule

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3 Confirm the schedule has been deleted.

Figure 10-37 Confirm schedule deletion

Changing the reference electrode

P Changing the reference electrode

1 Remove the top cover and open the measuring chamber cover.

Warning
r The reference electrode must be installed in the instrument no later than the
WARNING imprinted "Install before" date. The reference electrode must be replaced after 52
weeks of in-use time. Therefore, set up an alert in the Maintenance schedule.
U see Setting up the Maintenance schedule (p. 272)
U see Conventions used in this manual (p. 7) > Other symbols (p. 10)
r In order to ensure the quality of the measurement results, complete a quality
control test on 3 levels (1 = low, 2 = normal, 3 = high) after each electrode
exchange.

Figure 10-38 Reference electrode

Q In each case, open only the relevant measuring chamber.

Keep the bottle compartment cover closed.

The following screen appears:

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Figure 10-39

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 10-40 Insert the reference electrode

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

A Connector B Measuring chamber cassette

Figure 10-41 Insert the reference electrode 2

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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 levels (1 = low, 2 = normal, 3 = high) must
be performed after every exchange of a reference electrode.
Make sure that the results are in line with the target values.
U see Quality control (p. 173)
S

Changing the MSS cassette (cobas b 221<5> system and

cobas b 221<6> system only)

P Changing the MSS cassette

1 Remove the top cover.

Warning
r The MSS cassette must be installed in the instrument no later than the imprinted
WARNING "Install before" date.
U see Conventions used in this manual (p. 7) > Other symbols (p. 10)
r Replace the MSS cassette within 28 days of installation.
r In order to ensure the quality of the measurement results, complete a quality
control test on 3 levels (1 = low, 2 = normal, 3 = 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.

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

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).

Q Keep the bottle compartment cover closed.

The following screen appears:

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Figure 10-42

3 Open the contact clip and the locking lever.

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 10-43 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
U see Measurement (p. 143)
9 The MSS cassette is subsequently exposed to liquid, polarized, heated and
calibrated.

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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:
h System > Utilities > MSS polarization

Figure 10-44

12 Follow the instructions on the screen.

13 A new QC measurement must be performed with all three level (1 = low, 2 =
normal, 3 = high) after every exchange of the MSS cassette.
Make sure that the results are in line with the target values.
U see Quality control (p. 173)
S

Cleaning the measuring chambers

P Cleaning the measuring chambers

1 Remove the top cover and open the measuring chamber cover.
2 Remove all electrodes.
U see Replacement of the electrodes (p. 270)
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.

Q Do not scan a barcode. Instead, perform the following calibrations:

BG, ISE: calibrating the mixing system, 2P calibration
MSS: system calibration

U see section User-activated calibrations (p. 214)

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Surfaces

Warning
r Do not attempt to decontaminate any part of the instrument before shutting it down
WARNING and unplugging it from the power source.
r 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.
r 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.

Warning
r Never spray parts that cannot be removed or that are inside the instrument.
WARNING
U see section Decontamination (p. 247)

Changing of AutoQC mats

P Changing of AutoQC mats

1 Starting with the top level of the analyzer mode.
2 Pull out the AutoQC drawer.
The following screen appears:

Figure 10-45

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3 Remove the empty mat from the ampoule holder.

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.
If ampoules have expired as specified in the insert sheet, dispose of mats in accordance with
local regulations.
Caution: danger of spilling.

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

5 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 10-46 AutoQC mat

6 Place the mat in the defined position (A-F) of the ampoule block so that the
ampoules are no longer visible.
7 Press [Refill].
The following question appears:

Figure 10-47

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

Q Press [No] - if the new mat was not inserted from the same batch.
In this case the material has to be newly defined.
U See section Material setup (p. 179)

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9 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 10-48

10 Close the AutoQC drawer.

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Additional maintenance procedures

Additional maintenance procedures

Caution
r The listed maintenance procedures may only be performed by the Technical Support or
CAUTION by Roche authorized personnel.
r 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 the 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
Warning
r The tubing paths must also be disinfected annually and the baro value must be
WARNING checked.

Replacement every three years

Every three years the 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

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11 Troubleshooting cobas b 221 system
System stops

System stops

This error creates a window outlined in red halting the analyzer. An error message in
red is also displayed in the error window (upper right hand corner) on the display
screen. The error window will remain until corrective action is taken.
Follow the instructions on the screen.

Emergency routine

No. Message Cause Action

1000 Sample pos. error (1) The conductivity is not constant. o If discoloration can be detected by sample material
Possible causes: in the internal electrolyte of the electrode, it must be
replaced.
o Blockage or leak
o Separation of electrode membrane U see section Replacement of the electrodes (p. 270)
o Leaking electrodes o If the error persists perform General fluidics test to
isolate the error:
h System > Diagnostics > General fluidics test
and afterwards contact Technical Support
1001 Sample pos. error (2) The conductivity is too low. o If the error persists replace S2 Fluid Pack.
Possible causes: U see section Exchange of solutions and packs (p. 256)
o Blockage o Perform General fluidics test to isolate the error:
o No fluid in measuring chamber h System > Diagnostics > General fluidics test
Depending on the result, check the device for leaks or
clogs or contact Technical Support.
1002 Sample sep. error (1) No air packet was detected between Contact Technical Support.
calibration solution and sample. The
sample was not aspirated or aspirated
too late.
Possible causes:
o Deposits or blockage in measuring
chamber.
1003 Ref. sol. asp. error No reference solution was detected. o Perform Fill Reference Electrode:
Possible causes: h System > Utilities> Fluid actions > Fill
routines
o Blockage or leaks in reference
o If the error persists replace S2 Fluid Pack.
system
U see section Exchange of solutions and packs (p. 256)
If this error cannot be corrected, contact Technical
Support.
1004 Ref. sol. pos. error Conductivity level could not be o Check the electrode seating.
maintained. o Perform Calibration for Ready:
Possible causes: h Quick access > Calibration for Ready
o Detachment of electrode membrane If this error cannot be corrected, contact Technical
o Leaking electrodes Support.

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
AUTO-TROL PLUS B, Level 2 O O O O O O O O O O
03321177001
AUTO-TROL PLUS B, Level 3 O O O O O O O O O O
03321185001
COMBITROL PLUS B, Level 1 O O O O O O O O O O
03321193001
COMBITROL PLUS B, Level 2 O O O O O O O O O O
03321207001
COMBITROL PLUS B, Level 3 O O O O O O O O O O
03321215001
COOX/MSS Verification Material O O O O O O O O O O
03354628001(1)
TS/MSS Verification Material O O O O O O O O O O
03354601001(a)
Table 12-5
(1) Only for USA available.

O Can be used
Table 12-6

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Order information

Accessories

Parameter
- + +
Cl Na K Ca2+ PCO2 PO2 pH tHb/SO2 COOX/Bili MSS
Deproteinizer O O O O O O O O O O
03110435180
Adapter for Capillaries O O O O O O O O O O
03069931001
Ampoule Adapter O O O O O O O O O O
03066762001
Clot Catcher (1) O O O O O O O O O O
03112012180
Clot Catcher PRO(2) O O O O O O O O O O
05689856001
Cleaning Kit for Cl- Electrode O - - - - - - - - -
03112098035
Adapters for Sample Container O O O O O O O O O O
03112101180
Caps for Roche MICROSAMPLER O O O O O O O O O O
03112152180
Thermo Printer Paper O O O O O O O O O O
03113361180 (HP0107)
Roche MICROSAMPLER PROTECT, O O O O O O O O O O
non sterile
05772494001 (200 pcs.)
Roche MICROSAMPLER PROTECT, O O O O O O O O O O
sterile
05772583001 (50 pcs.)
Roche MICROSAMPLER PROTECT, O O O O O O O O O O
with accessories
05772591001(3)
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
Table 12-7
(1) The Clot catcher is not suitable for measurements in syringe mode and in "Aspiration from syringe" mode.
(2) The Clot Catcher PRO is not suitable for measurements in syringe mode and in "Aspiration from syringe" mode.
(3) Only for USA available

O Can be used
- Do not use
Table 12-8

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Order information

Parameter
Cl- Na+ K+ Ca2+ PCO2 PO2 pH tHb/SO2 COOX/Bili MSS
Sterile Capillary Holder - - - - O O O - - -
05174830001
Caps for Capillary Tubes O O O O O O O O O O
03113647035 (RE0410)
Customer Accessory Kit, O O O O O O O O O O
for cobas b 221<2>/<4>/<6> system
04975626001
Table 12-9

O Can be used
- Do not use
Table 12-10

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Glossary 13
Bottle tool serves for emptying the W Waste Container
and for degassing the S1 Rinse Solution.
"Ready" screen Main window of the analyzer mode.
BUN abbr. for blood urea nitrogen
1P 1-point calibration: an automatic calibration of
Bypass nipple Connection between the sample inlet
sensor parameters using a CAL1 solution.
path and the transverse channel
2P 2-point calibration: an automatic calibration of all
Calibration for Ready A calibration is selected to
parameters using CAL1, CAL2, and standby solutions of
bring all the activated parameters into the "Ready"
different concentrations. Optionally, cuvette layer
condition.
thickness can also be calibrated.
Clip Plastic fastener on S2 Fluid Pack and
Acid Base Diagram The log PCO2/pH diagram serves
S3 Fluid Pack.
as a basis for showing the rearranged Henderson-
Hasselbalch equation. Clot catcher Coagulum catcher for use with syringes
and capillaries
Alkaline basic
COMBITROL PLUS B QC material for controlling BG,
Analyzer Software mode for measuring, QC ISE, Glu, Lac, Urea/BUN, COOX/Bilirubin
measurement, system functions, calibration, quick
access. COMBITROL TS+ QC material for controlling BG,
ISE, Glu, Lac, Hct, tHb/SO2
AQC abbr. for AutoQC
Contact clip The MSS cassette inserted in the
Arterial blood Blood taken from the artery
measuring chamber slit is pressed into position and
AUTO-TROL PLUS B AutoQC material for thereby firmly positioned.
controlling BG, ISE, Glu, Lac, Urea/BUN,
COOX module The oximeter module consists of the
COOX/Bilirubin
hemolyzer and the COOX measuring chamber. It is an
AUTO-TROL TS+ AutoQC material for controlling optical sensor module for determining bilirubin (Bili),
BG, ISE, Glu, Lac, Hct, tHb/SO2 total hemoglobin (tHb), and the hemoglobin derivatives
oxyhemoglobin (O2Hb), desoxyhemoglobin (HHb),
AutoQC module The AutoQC module is a unit that
carboxyhemoglobin (COHb) and methemoglobin
automatically takes quality control measurements
(MetHb).
programmed by the user.
Docking mechanism Serves as an interface between
Barcode scanner PS2 hand-held scanner with
the packs or bottles and the fluid channels in the system
integrated decoder for simple input of QC data, electrode
data, patient or user identity. Dummy electrode A flow-through electrode without
any measuring function serving as a placeholder.
BG abbr. for blood gas
Electrodes are flow-through electrodes with a visible
BG measuring chamber The BG measuring chamber
sample channel.
with its sensors serves for measuring the pH value and
blood gas values PO2 and PCO2 Filling port Enables a sample to be injected or aspirated
from syringes, Roche MICROSAMPLER, capillaries and
Bilirubin is a yellow decomposition product of the red ampule adapters.
blood pigment, hemoglobin, or more exactly, that of the
hemoglobin share. Fixation lever serves for fixing the sensors in the
measuring chamber
Bottle compartment The bottle compartment
contains the W Waste Container, the S1 Rinse Solution FMS Fluid mixing system. In combination with the
bottle, the S2 Fluid Pack (with the solutions for BG and main pump this system guarantees the correct mixture of
ISE) and the S3 Fluid Pack (with the solutions for Glu, the calibration solutions CAL A and CAL B from the S2
Lac and Urea/BUN - only cobas b 221<5> system and Fluid Pack for the next calibrations, with the aid of the
cobas b 221<6> system). The bottle compartment also valves VM and V19.
contains the necessary docking mechanisms for Glass tube see Sample inlet path (SIP) (p. 337)
transporting the fluids into or out of the system.

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Hematocrit - Sample drip tray

Hematocrit in short, Hct, is the ratio of the volume of NIST standards define precise sera with certified
blood cells (mainly the red blood corpuscles) to the total expected values.
volume of blood.
Patient Trend Diagram Using this diagram, the
Hemoglobin is the main component of the course of individual parameters (measuring and
erythrocytes and serves for transporting oxygen. calculated values) of a patient over an indefinite period of
time can be shown and printed out.
Hemolyzer The sample is exposed to a strong
ultrasound field whereby the cell membranes of the Peristaltic pump see Pumps (p. 336)
erythrocytes are destroyed and the hemoglobin released.
Plasma Plasma samples are obtained by centrifuging
Heparin salts are the only permissible anticoagulants heparinized whole blood, whereby cellular cell parts of
the blood are separated.
Input unit Consists of the T&D module and the sample
drip tray. Pleural fluid Pleural fluid is a serous fluid produced by
the pleurae.
ISE abbr. for ion-selective electrode
Pleural space The thin space between the two pleural
ISE measuring chamber The ISE measuring
layers is known as the pleural space.
chamber with its sensors serves for measuring the
hematocrit value and the electrolyte values Na+, K+, Ca2+ Plug monitoring Infrared light barrier for detecting
plugged or unplugged sample containers.
and Cl-.
Polychromator Light is refracted and focused on the
Levey-Jennings diagram QC statistical values chart
surface of a photosensitive receiver (CCD).
LF Conductivity
PP abbr. for peristaltic pump.
Linear bracket White plastic part of the peristaltic
Printer A low-noise thermoprinter with integrated
pump.
paper cutter and optional paper winder.
MC abbr. for "measuring chamber"
Pumps The transport of the sample and the operating
Measurement evaluation Before clinical decisions fluids is effected by means of up to three peristaltic
are made on the basis of the results, the plausibility of all pumps, depending on the design (main pump, MSS
the measuring results obtained must always be checked output pump, MSS input pump).
by medical specialists, thereby taking the clinical
QC abbr. for quality control
situation of the patient into account.
QC material see AUTO-TROL PLUS B (p. 335),
Measuring chamber cassette serves for
AUTO-TROL TS+ (p. 335), COMBITROL PLUS B
transporting the samples and calibration solutions to the
(p. 335), COMBITROL TS+ (p. 335)
waste system after a measurement and/or calibration and
for adding the reference and rinse solution S1. Quality control The known target areas of the QC
materials are compared with the QC results of the
Module stop A certain module is not ready for use.
instrument.
Nevertheless, the parameters of other modules can still
be measured. RCon abbr. for reference contact. This is used for the
Glu/Lac or Glu instrument type and replaces the
MSS abbr. for metabolite sensitive sensors
reference electrode and dummy electrode.
MSS cassette is a multi-parameter sensor and
Reference electrode The reference electrode serves
contains the spots for measuring Glu, Lac, Urea/Bun
as a counter electrode of the measuring electrodes. Due
MSS measuring chamber The MSS measuring to the reference solution, its signal remains constant,
chamber with its sensors serves for measuring glucose, irrespective of the composition of the sample.
lactate and urea/BUN.
S1 Rinse Solution Wash solution
MSS polarization serves for wetting and preparing the
S2 Fluid Pack Calibration solutions BG, ISE
MSS cassette.
S3 Fluid Pack Calibration solutions Glu, Lac,
Multirules The valuation of the QC results is based on
Urea/BUN
the Westgard rules and their interpretation for the blood
gas analysis. The multirule procedure was derived from Sample drip tray Prevents dirtying the bottle
this. It enables malfunctions of the instrument to be compartment
detected at an early stage.

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Sample inlet path (SIP) - W Waste Container

Sample inlet path (SIP) Glass tube. Serves for Urea Urea (diamide of carbonic acid, Lat. urea pura) is
transporting fluids from the T&D disc via the needle to an organic compound and is produced as an end product
the sample distribution block (transverse channel). of the metabolism of nitrogen compounds (e.g. amino
acids) produced in the so-called urea cycle and then
Sample throughput Number of samples per hour
excreted in the urin.
Sample volume limit is the maximum volume
Vacuum pump Responsible for washing and drying
aspirated from a sample container.
the tubing (with the exception of the measuring
SCon abbr. for sensor contact. By means of the chambers).
conductivity contact, this electrode supports the
Valve V19 Air mixing valve
monitoring for filling the measuring chambers with
fluid. In addition, it measures the temperature in the Valve VM Mixing valve for calibration solutions CAL
measuring chamber. A and CAL B from S2 Fluid Pack.
Screen/PC unit Serves as a graphic user interface. All W Waste Container Waste container
the information (results, operating instructions, 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").
SO2 Oxygen saturation
System calibration This is carried out every 8, 12 or
24 hours (standard) and consists of wave-length
calibration of the polychromator, internal cleaning,
automatic conditioning of the Na+ electrode, calibration
of the mixing system and the 2-point calibration of all the
parameters.
System stop When this error occurs a window is
displayed with a red outline; the instrument stops.
System warnings Warning or indication that does
not require any direct action.
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

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W Waste Container - W Waste Container

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Index ............................................................................................................................................... 341

February 2014
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Index

Numerics – User-activated calibrations, 214

Calibration procedure, 29
1P calibration (1P cal), 213 Calibrations
2P calibration (2P cal), 213 – Automatic calibrations
– 2P calibration (2P cal), 213
Capillary measurement, 162
A Capillary tubes, 147
Change lot (applies only to AutoQC measurements), 186
Abbreviations, 10
Change the keyboard layout language, 49
Accessories, 46
Changing of AutoQC mats, 283
Acid base map, 169
Changing the air filter, 253
Air filter
Changing the MSS cassette, 280
– Changing the air filter, 253
Changing the reference electrode, 278
Analyzer mode, 226
Checking fill levels, 249
– Data manager, 229
Checking printer paper, 249
– QC measurement, 227
Cleaning fill port and sample drip tray, 250
– Quick access, 227
Cleaning the bottle compartment, 268
– Ready screen, 226
Cleaning the measuring chambers, 282
– Setup, 228
Cleaning the modules and sample paths
– System, 227
– Module cleaning, 262
Application area, 27
Cleaning the modules and tubing paths, 262
AQC status, 238
– Tubing paths, 263
Aspirate from syringe, 163
Cleaning the T&D disk, 252
Auflistung - Verbrauchsmaterialien, 329
Cleaning the touch screen, 250
Automatic calibrations, 213
Contact addresses, 4
– 1P calibration (1P cal) incl. O2, 213
Control - on board time, 188
– 2P calibration (2P cal), 213
Conversion table for units, 117
– Recalibration - without O2, 214
COOX calibration (for instrument versions with COOX
– System calibration, 213
module only), 253
AutoQC
COOX module, 38
– Specifications, 112
Copyright, 4
AutoQC materials - Material assignment, 181
Correlation to other methods, 98
AutoQC measurement, 198

D
B
Data export to diskette or USB, 229
Barcode, 325
Data input, 166
Barcode scanner, 41, 48
Data manager, 229
– Specifications, 114
– Calibrations, 232
Bottle compartment, 39
– General data manager functions, 229
Brands, 4
– Instrument, 233
Buttons, 224
– Measurements, 231
– Patients, 231
C – QC measurements, 232
– Utilities, 233
Cal. intervals & timing, 50 – Backup / Restore, 233
Calibration, 107, 211, 213 – Protected DB functions, 234
– 1P calibration (1P cal) incl. O2, 213 Date and Time, 49
– Automatic calibrations, 213 Decontamination, 32, 247
– Display of parameters during calibration, 216 – Input unit, 247
– Recalibration - without O2, 214 – Recommended disinfectants, 248
– System calibration, 213 – Surfaces of the instrument, 248

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– Touch Screen, 248 – For calibrations and QC measurements only, 229

– Tubing paths, 248 – For QC measurements only, 229
Delete a Maintenance schedule, 277 – General data manager functions, 229
Disposal of – On buttons, 224
– Bottles, 32 Important information, 19
– Electrodes, 32 Info, 235
– Instrument, 32 – AQC status, 238
– Packs, 32 – Fill levels, 235
– Waste water, 32 – Help, 235
– Messages, 240
– Miscellaneous reports, 239
E – Parameter report, 239
– Protected information, 241
Edit an existing Maintenance schedule, 275
– Sensor report, 240
Edition, 4
– Status report, 240
Edition notice, 3
– QC status, 236
Electrodes
– Versions, 239
– Handling electrodes, 34
– Video sequences, 236
Environmental parameters, 108
Input unit, 39
– Temperature / humidity / stability, 108
Installation, 45, 48
Equations, 118
– Accessories, 46
Exchange of solutions and packs, 256
– Attach power cord and barcode scanner, 48
– S1 rinse solution / S2 fluid pack / S3 fluid pack, 256
– Cal. intervals & timing, 50
– Waste water, 259
– Checking the barometer value, 63
– Exchange the waste water container (W Waste
– Complete installation, 62
Container), 259
– Fix screws at V19 (bottle compartment), 50
Exchanging the fill port, 265
– Go to AutoQC home position, 57
Exchanging the peristaltic pump tubes, 266
– Go to AutoQC service position, 56
– Insert fill port and sample inlet path (glass tube), 52
F – Insert peristaltic pump tubes, 55
– Insert printer paper, 54
Fill levels, 235 – Insert right FMS tube at VM (bottle compartment), 51
– Checking fill levels, 249 – Instrument location, 45
– Open AutoQC drawer and insert ampoule holder, 57
– Open bottle compartment cover and insert Waste
G container & packs, 57
– Open the AutoQC drawer and remove the AutoQC
General notes, 27
valve clamp, 56
General QC concept, 176
– Open the measuring chamber cover and insert the
Glossary, 335
sensors, 59
– Perform MSS polarization, 63
H – Power supply, 47
– Quality control, 64
Handling electrodes, 34 – Screen/PC unit, 47
Handling samples, 32 – Select language, 48
Handling solutions, 33 – Set the date and time, 49
Hct – Switch on, 48
– Interferences, 151 Interfaces, 40
Help, 235 Interferences, 151
Hemoglobin derivatives and bilirubin, 158 – Hb derivatives and bilirubin, 154
How to use this manual, 7 – MSS, 153
– pH, Hct, ISE, 151
– tHb/SO2, 151
I ISE
– Interferences, 151
Icons, 221
– For Backup / Restore only, 230
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L Material setup, 179

Measurement, 143
Language, 48 Measurement evaluation, 31
Last patients, 170 Measurement parameters, 79
Limitations of clinical analysis, 157 Measurement procedure, 29
– Blood gas, 157 – Use as default setup, 165
– Electrolytes, 157 Measurement times of the samples, 104
– General, 157 Measuring chamber, 38
– Hemoglobin derivatives and bilirubin, 158 Measuring procedure, 160
– Metabolites, 158 – Aspirate from syringe, 163
– pH measurements on pleural fluid, 159 – Capillary measurement, 162
– tHb/SO2, 158 – Data input, 166
Linearity, 89 – Acid base map, 169
List of all activities, 236 – Last patients, 170
List of all warnings, 238 – Mandatory input, 166
Location, 45 – Patient trending map, 168
– Result, 168
– Sample distribution, 167
M – Syringe mode, 160
Messages, 240
Maintenance, 245
Metabolites, 158
– Additional maintenance procedures, 286
Miscellaneous reports, 239
– Daily, 249
Module stops, 300
– Checking fill levels, 249
MSS
– Checking printer paper, 249
– Interferences, 153
– Decontamination, 247
MSS cassette
– Input unit, 247
– General notes on the use of the MSS cassette, 35
– Recommended disinfectants, 248
– Inserting the MSS cassette, 36
– Surfaces of the instrument, 248
– MSS cassette removed from the measuring chamber, 35
– Touch Screen, 248
MSS measuring chamber
– Tubing paths, 248
– Incompatible substances, 35
– General, 247
Multirules, 199
– Quarterly, 252
– Overview of the Multirules, 200
– Changing the air filter, 253
– Cleaning the T&D disk, 252
– COOX calibration (for instrument versions with O
COOX module only), 253
– Sample-dependent maintenance procedures, 256 Operating instructions, 27
– Cleaning the modules and tubing paths, 262 Operating safety information, 20
– Exchange of solutions and packs, 256 Operator’s Manual
– Unscheduled, 265 – conventions used, 7
– Changing of AutoQC mats, 283 – find information, 7
– Changing the MSS cassette, 280 – version, 3
– Changing the reference electrode, 278 Order information
– Cleaning the bottle compartment, 268 – Accessories, 333
– Cleaning the measuring chambers, 282 – Electrodes, 331
– Exchanging the fill port, 265 – QC material, 332
– Exchanging the peristaltic pump tubes, 266 – Solutions, 332
– Replacement of the electrodes, 270
– Replacing printer paper, 268
– Surfaces, 283
P
– Weekly, 250
Parameter
– Cleaning fill port and sample drip tray, 250
– Calculation values, 221
– Cleaning the touch screen, 250
– Calculation values at the patient’s temperature, 221
Mandatory input, 166
– Display on the Ready screen (analyzer mode), 221
Manual QC measurement, 196
– Input parameters, 221
Material assignment - AutoQC materials, 181
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– Measurements (depending on configuration), 221 QC warning, 202

– Notation of the measurement, input, and calculation Quality control, 331
values, 221 – Control - on board time, 188
Parameter / icons, 221 – General, 175
Parameter report, 239 – General QC concept, 176
Patient trending map, 168 – Important information concerning the analysis of QC
Performance data, 79 measurement results, 178
– Correlation to other methods, 98 – Material setup, 179
– Linearity, 89 – Change lot (applies only to AutoQC
– Measurement parameters, 79 measurements), 186
– Reproducibility, 80 – Inserting the AutoQC mats, 181
pH – materials, 181
– Interferences, 151 – QC timing, 184
Pleural fluid, 150 – Multirules, 199
– pH measurements, 159 – Overview of the Multirules, 200
POC mode (Point-of-care mode), 171 – QC consequences, 201
Power cord, 48 – QC for Ready (with AutoQC module), 204
Power supply, 40, 47 – QC for Ready (without AutoQC module), 206
Preanalytics, 145 – QC measurement, 196
Precision, 80 – AutoQC measurement, 198
Printer, 38 – Manual QC measurement, 196
– Checking printer paper, 249 – QC troubleshooting, 208
– Insert printer paper, 54 – Remove the QC lock, 202
– Remove the printer paper, 69 – QC lock, 202
– Replacing printer paper, 268 – QC warning, 202
– Specifications, 112 Quick access, 227
Product data, 111
– Acoustic Noise Level, 111
– Classification, 111
R
– Dimensions, 111
Ready screen, 226
– Electrical data, 111
Recalibration - without O2, 214
– Holding points, 112
Reference and critical values, 132
– Weight, 111
– Carboxyhemoglobin (COHb), 138
Pumps, 39
– Chloride, 135
– Desoxyhemoglobin (HHb), 138
Q – Glucose, 139
– Hematocrit, 135
QC consequences, 201 – Ionized calcium, 135
QC for Ready (with AutoQC module), 204 – Lactate, 139
QC for Ready (without AutoQC module), 206 – Methemoglobin (MetHb), 138
QC lock, 202 – Oxygen saturation (SO2), 137
– Automatic correction, 202 – Oxyhemoglobin (O2Hb), 137
– Exchange correction, 203 – PCO2, 133
– Manual correction, 202 – pH, 132
QC measurement, 196, 227 – PO2, 133
– AutoQC measurement, 198 – Potassium, 134
– Manual QC measurement, 196 – Sodium, 134
QC status, 236 – tHb (total hemoglobin concentration), 136
QC timing, 184 – Total bilirubin (=neonatal), 138
QC troubleshooting, 208 – Urea/BUN, 140
– Classification of QC problems, 208 Remove the QC lock, 202
– Description of the current problem, 208 – QC lock, 202
– Troubleshooting - Group A (aspirating or positioning – Automatic correction, 202
problem), 208 – Exchange correction, 203
– Troubleshooting - Group B (QC result exceeds the – Manual correction, 202
target value range), 209 – QC warning, 202
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Replacement of the electrodes, 270 – Open AutoQC drawer and insert the AutoQC valve
Result, 168 clamp, 72
Reverse side, 39 – Open bottle compartment cover and only remove bottle
Revision History, 3 S1 and packs (depending on the configuration S2 and
Revisions, 349 S3), 66
Roche MICROSAMPLER PROTECT, 148 – Open T&D, 69
– Open the AutoQC drawer and remove the ampoule
holder, 72
S – Open the measuring chamber cover and remove the
sensors, 67
S1 rinse solution, 256
– Release screws at V19 (bottle compartment), 71
S2 fluid pack, 256
– Remove fill port and sample inlet path (glass tube), 69
S3 fluid pack, 256
– Remove right FMS tube at VM (bottle compartment),
Safety information, 17
71
Safety instructions for specific dangers, 32
– Remove shutdown kit from space S2, 66
Sample collection, 145
– Remove shutdown kit from space S3, 67
– Anticoagulants, 145
– Remove the peristaltic pump tubes, 68
– Sample acquisition, 145
– Remove the printer paper, 69
– Sample collection especially for bilirubin measurement,
– Remove Waste container, 67
146
– Set valves for FMS tubing exchange, 71
– Sample collection especially for glucose / lactate
Software
measurement, 146
– version, 3
– Sample collection especially for tHb, SO2 and Hct
Software modes, 217
measurement, 145
– Analyzer mode, 226
Sample collection container
– Ready screen, 226
– Accessories, 148
– General, 219
Sample collection container accessories
– Info, 235
– Clot catcher, 148
– User interface, 219
– Clot Catcher PRO, 148
Solutions
Sample containers, 147
– Handling solutions, 33
– Capillary tubes, 147
Specifications
– Roche MICROSAMPLER PROTECT, 148
– Touch screen-PC unit, 113
– Syringes, 147
– SN, 113
Sample distribution, 167
– SN > 1500, 113
Sample handling, 149
– SN > 5000, 113
– Plasma, 149
Standard values and ranges, 117
– Pleural fluid, 150
Status messages of measuring and calibration values, 308
– Serum, 149
Status messages on the measurement report, 324
Sample throughput, 103
Symbols, 7
Sample types, 106
Syringe mode, 160
Sample volumes, 105
Syringes, 147
Sampling handling
System, 227
– Whole blood, 149
System calibration, 213
Screen/PC unit, 37, 47
System description, 37
Sensor report, 240
– Barcode scanner, 41
Set up a New Maintenance schedule, 273
– Bottle compartment, 39
Setting up the Maintenance schedule, 272
– COOX module, 38
Setup, 228
– Input unit, 39
Shutdown, 65
– Interfaces, 40
– Complete shutdown, 73
– Measuring chamber, 38
– Fill the shutdown kit with distilled water, 66
– Power supply, 40
– Go to AutoQC home position, 72, 73
– Printer, 38
– Go to AutoQC service position, 72
– Pumps, 39
– Insert shutdown kit into space S2, 66
– Reverse side, 39
– Insert shutdown kit into space S3, 67
– Screen/PC unit, 37
– Less than 24 hours, 65
– tHb/SO2 module, 38
– Longer than 24 hours, 65
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– Visual identification, 37
– Warning and identification labels (incl. nameplate), 42
System stops, 294
– Emergency routine, 294
System warnings, 304

T&D disk
– Cleaning, 252
Temperature / humidity / stability, 108
tHb/SO2
– Interferences, 151
tHb/SO2 module, 38
Touch screen
– Cleaning, 250
Troubleshooting, 291
– Barcode, 325
– Module stops, 300
– Status messages of measuring and calibration values,
308
– System stops, 294
– Emergency routine, 294
– System warnings, 304
– Troubleshooting - general, 293
Tubing paths, 263

Use as default setup, 165

User interface, 219
– Buttons, 224
User-activated calibrations, 214

Versions, 239
Video sequences, 236

Warning and identification labels (incl. nameplate), 42

Waste water, 259
– Exchange the waste water container (W Waste
Container), 259

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13 Revisions......................................................................................................................................... 349

February 2014
cobas b 221 system Revisions
Table of contents

Revisions

This chapter contains revisions to the cobas b 221 system Instructions for Use that
were necessary due to a new software update, which includes updated reference
ranges and new features for monitoring bacterial contamination.

In this chapter Chapter

Revisions to the cobas b 221 system Instructions for Use ........................................... 351
Structure of a changed entry...................................................................................... 351
Revision 1: Reference and critical ranges updated........................................................ 352
Reference and critical ranges ..................................................................................... 352
Reference/normal ranges ..................................................................................... 353
Critical ranges........................................................................................................ 354
Revision 2: New maintenance procedure added ........................................................... 355
Monitoring MSS contamination ............................................................................... 355
Revision 3: New module stop message........................................................................... 358
Revision 4: New system warning message ..................................................................... 359

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Table of contents

Roche Diagnostics September 2015

350 Instructions for Use · Version 14.1
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Revisions to the cobas b 221 system Instructions for Use

Revisions to the cobas b 221 system Instructions for Use

Manual Version Software Version Revision Date Changes

14.1 ≥8.01 September 2015 Software update
Table 13-1 Revision History

In order to ensure that readers of the cobas b 221 system Instructions for Use use the
most up-to-date content, Roche recommends to manually mark the affected
passage(s) in the original manual.
To update the cobas b 221 system Instructions for Use:
1. In the current chapter Revisions, go to the first revision.
2. Familiarize yourself with the items that have been revised.
3. Identify the page number affected in the original document.
4. Go to the appropriate page in the original document and manually mark the
revisions. For example, cross out text that is no longer applicable or add a
reference where to find new and revised content.

q If you print these pages, Roche recommends printing them single-sided. In this way, you
can easily insert them in the existing document

Structure of a changed entry

The following illustration explains how revisions are presented in this document.

C
D

A Change ID C Page(s) affected

B Change summary D Changed element

Figure 13-1 Structure of a changed entry

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Revision 1: Reference and critical ranges updated

Revision 1: Reference and critical ranges updated

Revised page numbers This section should replace pages 132 to 140, inclusive, of the cobas b 221 system
Instructions for Use, Version 14.0.

Reference and critical ranges

The results of laboratory tests have little practical utility until clinical studies have
ascribed various states of health and disease to intervals of values.(1)

q Reference values are default values. If required, you can adjust the default values.

Reference intervals are useful because they attempt to describe the typical results
found in a defined population of apparently healthy people. Different methods may
yield different values, depending on calibration and other technical considerations.
Hence, different reference intervals and results may be obtained in different
laboratories.
Reference intervals, although useful as guideline for clinicians, should not be used as
absolute indicators of health and disease.(2)

Warning
r The reference intervals presented in this chapter are for general information purposes
WARNING only. The proposed default reference ranges refer in general to adults and unspecified
gender. They can be adjusted and specifically defined by gender, age, and sample type.
Please refer to the reference manual for information on how to adjust reference values.
r Individual laboratories should generate their own set of reference intervals.

(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th Edition 2006, p. 2252
(2) see Chapter 16 of "Tietz Textbook of Clinical Chemistry and Molecular Diagnostics", 4th Edition 2006

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Reference/normal ranges

Parameter Normal range Sample matrix Unit Reference values (Default Source
values, also seen on
printouts)
COHb ≤3 nonsmoker Whole blood heparin % 0.0 - 3.0(1) Lothar Thomas, Labor und
(%) Diagnose, 8. Auflage, p. 848

MetHb 0.04 - 1.52 Whole blood heparin % 0.0 - 1.5(2) Tietz Textbook of Clinical
(% of total Hb) Chemistry and Molecular
Diagnostics, 5th edition
2012, p. 2160
O2Hb 94.0 - 98.0 Arterial blood % 94.0 - 98.0 Lothar Thomas, Labor und
(%) Diagnose, 8. Auflage, p. 535
SO2/O2 94.0 - 98.0 Whole blood arterial % 94.0 - 98.0 Tietz Textbook of Clinical
saturation (%) Chemistry and Molecular
Diagnostics, 5th edition
2012, p. 2162
HHb <3 % 0.0 - 2.9 Kenneth A. Wyka, Paul J.
(%) Mathews, John Rutkowski:
Foundations of respiratory
care, p. 153
tHb 11.5-16.0 (female Capillary blood g/dL 11.5 - 17.8 unknown(3) Lothar Thomas, Labor und
(g/dL) adult), 13.5-17.8 Diagnose, 8. Auflage, p. 827
(male adult)
Bilirubin 2.0 - 6.0 (0-1 d full Serum mg/dL 2.0 - 10.0 (fetal/new born)(4) Tietz Textbook of Clinical
Bili term) 4.0 - 8.0 (2nd day/1 year) Chemistry and Molecular
(mg/dL) 6.0 -10.0 (1-2 d full 0.0 - 2.0 (> 1 year) Diagnostics, 5th edition
term) 0.0 - 2.0 (unknown) 2012, p. 2136
4.0 - 8.0 (3- 5 d full
term)
0.0 - 2.0 (adult)
pH 7.35 - 7.45 Whole blood arterial 7.350 - 7.450 Tietz Textbook of Clinical
Chemistry and Molecular
Diagnostics, 5th edition
2012, p. 2162
pCO2 32 - 45 (female Whole blood, arterial mmHg 32.0 - 48.0 unknown(c) Tietz Textbook of Clinical
(mmHg) adult) heparin Chemistry and Molecular
35 - 48 (male Diagnostics, 5th edition
adult) 2012, p. 2137
pO2 83 - 108 Whole blood arterial mmHg 83.0 - 108.0 Tietz Textbook of Clinical
(mmHg) Chemistry and Molecular
Diagnostics, 5th edition
2012, p. 2162
Sodium 136 - 145 Serum, plasma mmol/L 136.0 - 145.0 Tietz Textbook of Clinical
Na+ Chemistry and Molecular
(mmol/L) Diagnostics, 5th edition
2012, p. 2168
Potassium 3.5 - 5.1 Serum mmol/L 3.50 - 5.10 Tietz Textbook of Clinical
K+ Chemistry and Molecular
(mmol/L) Diagnostics, 5th edition
2012, p. 2164
Ionized 1.15 - 1.33 Serum, plasma mmol/L 1.150 - 1.330 Tietz Textbook of Clinical
Calcium Ca2+ heparin Chemistry and Molecular
(mmol/L) Diagnostics, 5th edition
2012, p. 2137
Table 5-4 Reference/normal ranges

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Revision 1: Reference and critical ranges updated

Parameter Normal range Sample matrix Unit Reference values (Default Source
values, also seen on
printouts)
Chloride 98 - 107 Serum, plasma mmol/L 98.0 - 107.0 Tietz Textbook of Clinical
Cl- Chemistry and Molecular
(mmol/L) Diagnostics, 5th edition
2012, p. 2139
Hematocrit 36 - 48 (Caucasian Whole blood, % 36.0 - 53.0 unknown(5) Lothar Thomas, Labor und
HCT (%) female) Capillary blood Diagnose, 8. Auflage, p. 840
40 - 53 (Caucasian
male)
Glucose 3.5 - 5.3 Whole blood heparin mmol/L 3.5 - 5.3 Tietz Textbook of Clinical
Glu Chemistry and Molecular
(mmol/L) Diagnostics, 5th edition
2012, p. 2149
Lactate 0.56 - 1.39 Venous whole blood mmol/L 0.6 - 1.4 Tietz Textbook of Clinical
Lac heparin, bed rest Chemistry and Molecular
(mmol/L) Diagnostics, 5th edition
2012, p. 2156
Urea/BUN 2.1 - 7.1 Serum mmol/L 2.1 - 7.1 Tietz Textbook of Clinical
(mmol/L) Chemistry and Molecular
Diagnostics, 5th edition
2012, p. 2173
Table 5-4 Reference/normal ranges
(1) Upper limit refer to nonsmoker.
(2) Default value rounded to one tenth place value.
(3) Proposed reference range refers to lower limit for females to upper limit of males if the gender is unknown.
(4) For "fetal/new born", the proposed reference range refers to lower level of 0·1 day old full-term to upper level of 1·2 days full-term. For "2nd day /1
year", the proposed reference range refers to the reference value for 3-5 days full-term. For "> 1 year'' and "unknown", the proposed value refers to
the one of adults. Because of the lower end of the measuring range for Bilirubin (3.0 mg/dL; 51μmol/L), it cannot be edited by the user. The user can
only edit values within the measuring range. However, it is possible to set the new reference values using the button "Set default ranges" for the age
specific reference range.
(5) Proposed reference range refers to lower limit for Caucasian females to upper limit of Caucasian males.

The availability of parameters depends on the configuration:

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

o cobas b 221<2> system BG, pH, COOX, Bili
o cobas b 221<3> system(1) BG, pH, ISE, Hct, tHb/SO2
o cobas b 221<4> system BG, pH, ISE, Hct, COOX, Bili
o cobas b 221<5> system(1) BG, pH, ISE, Hct, MSS, tHb/SO2
o cobas b 221<6> system BG, pH, ISE, Hct, MSS, COOX, Bili
(1) are no longer manufactured or offered.

Critical ranges
Normal values depend, amongst other factors, on the patient, age, gender, lifestyle
habits (e.g. smoking), underlying disease (e.g. asthma), and therapy (e.g. state after an
infusion). This especially applies to critical ranges, as these are based on the normal
values. Therefore, critical ranges can only be approximately defined and need special
attention if used for therapy decision. By default, critical values are not contained in
the default setting. Laboratories must adjust the critical ranges to fulfill their own
requirements.

Roche Diagnostics September 2015

354 Instructions for Use · Version 14.1
cobas b 221 system Revisions
Revision 2: New maintenance procedure added

Revision 2: New maintenance procedure added

Revised page numbers This section should be placed in front of page 265 of the cobas b 221 system
Instructions for Use, Version 14.0.

Monitoring MSS contamination

Automatic and manual monitoring of MSS contamination allows you to detect

bacterial contamination in the S3-fluidic pathways before it has any effect on the MSS
calibration, and consequently cobas b 221 system measurements.
You must select a day of the week when the system automatically monitors MSS
contamination. In addition, you can perform a test manually if you find signs of
bacterial contamination in the system.
If bacterial contamination has been detected, the system activates a warning period.
This warning period can last up to 10 days. If the system reaches the end of the
warning period, the MSS module stops. However, if MSS measurements no longer
follow specifications, the MSS module stops immediately.
A system warning or an MSS module stop is only deactivated once Technical Support
has performed the MSS maintenance procedure on the system.

Incorrect patient results due to bacterial contamination

Bacterial contamination in the S3-fluidic pathway reduces the quality and integrity of the
WARNING S3 calibration solution for GLU/LAC/UREA parameters and the MSS cassette. This leads to
incorrect QC measurements and/or incorrect patient results, which may endanger patient
lives.
r Do not attempt to deactivate weekly MSS contamination monitoring.
r Perform the MSS contamination test immediately if you find signs of bacterial
contamination in the system.

p To set up automatic MSS contamination monitoring

1 To choose an MSS contamination monitoring day, press the following buttons:
Setup > Times & intervals > MSS contamination monitoring day

Figure 10-A Times & intervals screen in Setup mode

Roche Diagnostics September 2015

Instructions for Use · Version 14.1 355
Revisions cobas b 221 system
Revision 2: New maintenance procedure added

2 To scroll through the days of the week and choose an MSS contamination
monitoring day, press the and buttons.

Figure 10-B MSS contamination monitoring setup screen

3 To save your settings, press the button.

4 To confirm your schedule setup, press the MSS contamination monitoring day
button.

q Monitoring dates are automatically rescheduled to the next day if one of the following
circumstances occurs to the system:
o It is not switched on
o It is on standby mode for more than 24 hours
o It cannot perform PO2 measurements
If monitoring dates are repeatedly rescheduled, you will receive a system warning and
you will require a Technical Support visit.

Roche Diagnostics September 2015

356 Instructions for Use · Version 14.1
cobas b 221 system Revisions
Revision 2: New maintenance procedure added

p To test for MSS contamination manually

q MSS contamination tests can only be performed if all of these conditions are true:
o 25 minutes have elapsed since the last 1P calibration of the MSS module
o 3 hours have elapsed since the last 2P calibration of the MSS module
o PO2 is calibrated and QC lock is not applied
o There are no active system warnings or module stops related to MSS contamination
u To check when previous calibrations have occurred, refer to the Software modes chapter
in the Instructions for Use, under Calibrations in the Data Manager section.

1 To test for MSS contamination, press the following buttons:

System > Diagnostics > MSS contamination test

Figure 10-C Diagnostics screen in System mode

Roche Diagnostics September 2015

Instructions for Use · Version 14.1 357
Revisions cobas b 221 system
Revision 3: New module stop message

Revision 3: New module stop message

Revised page numbers This section should be placed in front of page 303 of the cobas b 221 system
Instructions for Use, Version 14.0.

No. Message Cause Action

20090 MSS contaminated Bacterial contamination detected. MSS maintenance procedure is required. Contact
Technical Support.
Table 11-2 Module stops

Roche Diagnostics September 2015

358 Instructions for Use · Version 14.1
cobas b 221 system Revisions
Revision 4: New system warning message

Revision 4: New system warning message

Revised page numbers This section should be placed in front of page 305 of the cobas b 221 system
Instructions for Use, Version 14.0.

No. Message Cause Action

30007 MSS contaminated Bacterial contamination detected. MSS maintenance procedure is required. Contact
Technical Support.
Table 11-3 System warnings

Roche Diagnostics September 2015

Instructions for Use · Version 14.1 359
Revisions cobas b 221 system
Revision 4: New system warning message

Roche Diagnostics September 2015

360 Instructions for Use · Version 14.1

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