Roche Cobas B221 User manual
cobas b 221 system
Instructions for Use
COBAS, COBAS B and LIFE NEEDS ANSWERS
are trademarks of Roche.
Roche Diagnostics GmbH
D-68298 Mannheim
Germany
www.roche-diagnostics.com
©2009 Roche Diagnostics
cobas b 221 system
Revision History
Manual Version Software Version Revision date Changes
2.0 1.0 May 2003 Launch
3.0 1.0 June 2003 not delivered
3.1 1.02 July 2003
4.0 2.0 March 2004
5.0 4.0 December 2004
6.0 5.0 November 2005
7.0 5.0 March 2006 cobas Branding
8.0 6.0 December 2006
9.0 7.0 February 2008
10.0 >7.0 April 2009
Edition notice
Copyright
cobas b 221 system
In the course of 2006 the Roche OMNI S system was relaunched under the
Roche Diagnostics professional IVD user brand cobas®.
Systems with a serial number of 5001 or above are cobas b 221 systems.
Systems with a serial number up to 5000 are Roche OMNI S systems.
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves
the right to make any changes necessary without notice as part of ongoing product
development.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Software updates are done by Roche Service representatives.
© 2009, Roche Diagnostics GmbH, all rights reserved
The contents of this document may not be reproduced in any form or communicated
to any third party without the prior written consent of Roche Diagnostics.
While every effort is made to ensure its correctness, Roche Diagnostics assumes no
responsibility for errors or omissions which may appear in this document.
Subject to change without notice.
Roche Diagnostics April 2009
Instructions for Use · Revision 10.0 1
Brands
Contact addresses
cobas b 221 system
COBAS, COBAS B, LIFE NEEDS ANSWERS, ROCHE OMNI, AUTOQC,
ROCHE MICROSAMPLER, COMBITROL and AUTO-TROL are trademarks of
Roche.
Edition
Manufacturer
Roche Diagnostics GmbH
D-68298 Mannheim / Germany
www.roche.com
Revision 10.0, April 2009
First edition: May 2003
REF/No. 03261395001
Roche Diagnostics April 2009
2 Instructions for Use · Revision 10.0
cobas b 221 system
Table of contents
Revision History 1
Edition notice 1
Copyright 1
Brands 2
Contact addresses 2
Edition 2
Tab l e o f co n ten t s 3
Preface 5
How to use this manual 5
Where to find information 5
Conventions used in this manual 5
Introduction and specifications Part A
1 Safety information
Important information A-5
Operating safety information A-6
2 General descriptions
Introduction A-9
General notes A-11
Measurement and calibration procedure A-13
Measurement evaluation A-14
Safety instructions for specific dangers A-14
Handling solutions A-15
Handling electrodes A-15
General notes on the use of the MSS cassette A-16
System description A-18
Operation Part B
6 Measurement
Preanalytics B-5
Interferences B-10
Limitations of clinical analysis B-17
Measuring procedure B-19
7 Quality control
Quality control - general B-33
General QC concept B-33
Important information concerning the analysis of QC
measurement results B-35
Material setup B-36
QC setup wizard B-44
QC measurement B-51
Multirules B-53
QC consequences B-55
Remove the QC lock B-56
QC for Ready (with AutoQC module) B-57
QC for Ready (without AutoQC module) B-59
QC troubleshooting B-61
8Calibration
Calibration - general B-65
Automatic calibrations B-65
User-activated calibrations B-66
Display of parameters during calibration B-68
3 Installation and shutdown
Installation A-27
Shutdown A-48
9 Software modes
Software modes - general B-71
User interface B-71
Analyzer mode B-78
4 Specifications
Performance data A-59
Sample throughput A-86
Setup B-80
Data manager B-81
Info B-87
Measurement times of the samples A-86
Sample volumes A-87
Sample types A-87
Maintenance Part C
Calibrations A-88
Environmental parameters A-89
Product data A-91
AutoQC A-92
Printer A-92
Touch screen-PC unit A-93
Barcode scanner A-94
10 Maintenance
Maintenance - general C-5
Decontamination C-5
Daily C-7
Weekly C-8
Quarterly C-9
Sample-dependent maintenance procedures C-13
5 Theoretical foundations
Parameters and calculations A-97
Unscheduled C-22
Additional maintenance procedures C-38
Clinical significance A-109
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Troubleshooting Part D
11 Troubleshooting
Troubleshooting - general D-5
System stops D-5
Module stops D-12
System warnings D-16
Status messages of measuring and calibration values
D-20
Status messages on the measurement report D-39
Barcode D-40
Appendix Part E
12 List of consumables
Order information E-5
Glossary E-9
cobas b 221 system
Index Part F
Index F-3
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cobas b 221 system
Preface
The cobas b 221 system is an analyzer with integrated AutoQC drawer option.
This manual has detailed descriptions of cobas b 221 system features and general
operational concepts, specification functions and use of controls, operating
techniques, emergency procedures, product labeling and maintenance procedures.
How to use this manual
o
Keep this manual in a safe place to ensure that it is not damaged and remains available for use.
o
This Instructions for Use should be easily accessible at all times.
To help you find information quickly, there is a table of contents at the beginning of
the book and each chapter. In addition, a complete index can be found at the end.
Where to find information
In addition to the Instructions for Use, the following documents are also provided to
assist in finding desired information quickly:
o cobas b 221 system Reference Manual
o cobas b 221 system Short Instruction
Conventions used in this manual
Visual cues are used to help locate and interpret information in this manual quickly.
This section explains formatting conventions used in this manual.
Symbols Helping to locate and interpret information in this manual the following symbols are
used:
Symbol Used for
a Procedural step
o List item
e
h Call up of screen
Cross-reference
Note
Roche Diagnostics April 2009
Instructions for Use · Revision 10.0 5
Symbol Used for
Caution
All sections / passages that are marked with this symbol describe procedures
and/or indicate conditions or dangers that could damage or lead to a
malfunction in the cobas b 221 system, and which therefore should never be
attempted and contain information that must be observed to avoid potential
injuries (to patients, users and third parties).
Risk of infection
All sections and parts of texts that are marked with this symbol describe
procedures that may involve risk of infection.
cobas b 221 system
IVD symbols The symbols are used in accordance with DIN EN 980
Symbol Description
Conformité Européenne:
This product complies with the requirements in the guideline for
In Vitro Diagnostic 98/79/EC.
Lot designation
Use by...
The product should not be used after expiry of the specified date.
If a day is not indicated, apply the last day of the respective month.
Temperature limitation
The conditions necessary to preserve the product's shelf life before
opening.
In Vitro Diagnostic Medical Device
Manufacturer
(according to In Vitro Diagnostic guidelines 98/79/EG)
Catalogue number
(a)
and DIN EN ISO 780
(b)
.
Serial number (model plate)
Caution, consult accompanying documents
Please consult instructions for use
(a) DIN EN 980: Medical devices - Symbols to be used with medica l device labels, labelling and information
to be supplied (Part 1: General requirements)
(b) DIN EN ISO 780: Packaging - Pictorial marking for the handling of goods
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cobas b 221 system
Symbol Description
Biological risk!
(according to the standard IEC/EN 61010-2-101)
Biological risk!
(according to the standard DIN EN ISO 980)
Do not use if package damaged
Do not reuse
Fragile. Handle with care
Handle with care
(a)
(Instrument)
(b)
(Consumables)
Valid only for Roche MICROSAMPLER:
Method of sterilization using ethylene oxide
Valid only for BS2 Blood Sampler:
Method of sterilization using irradiation
(a) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control, and
laboratory use - (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment).
(b) DIN EN ISO 980: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied (Part 1: General requirements).
Other symbols The following symbols are listed as additional information:
Symbol Description
Electrodes:
This date indicates the limit of the maximum storage time of
an electrode. The electrode must be installed in the instrument
no later than the imprinted date.
If the installation takes place on the imprinted date, it still falls
within the specifications. The calculation of the “Install
before” date is based on the production date of the elctrode.
Danger symbol: "Irritant" (on the label and the packaging of
S2 Fluid Pack)
Rating: Although not corrosive, momentary, longer-lasting, or
repeated contact with skin or mucous membrane may result in
inflammation. Danger of sensitization during contact with
skin (when classified with R 43).
Caution: Avoid contact with eyes and skin, do not inhale
vapors.
Roche Diagnostics April 2009
Instructions for Use · Revision 10.0 7
Symbol Description
Invisible Laser Radiation
Avoid direct radiation to eyes!
Laser Class 3R according to EN 60825-1
P0 ≤ 5 mW
λ = 635 - 850 nm
Store upright
"Grüner Punkt" (in Germany)
Protective gloves, protective goggles and suitable protective
clothing must be worn.
Abbreviations The following abbreviations are used:
cobas b 221 system
Abbreviation Definition
A
ANSI American National Standards Institute
AQC Automatic Quality Control
B
BG Blood gas
BUN Abbr. for blood urea nitrogen
C
CLIA Clinical Laboratory Improvement Amendments
CLSI Clinical and Laboratory Standards Institute
cond Conductivity
CSA Canadian Standards Association
D
dBA Decibel weighted against the A-frequency response curve. This curve
approximates the audible range of the human ear.
DIL Diluent
DNS Domain Name Server
E
EC European community
e.g. exempli gratia – for example
EN European standard
F
FMS Fluid mixing system
H
Hct Hematrocrit
HIV Human immunodeficiency virus
HW Hardware
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8 Instructions for Use · Revision 10.0
cobas b 221 system
Abbreviation Definition
I
i.e. id est – that is to say
ISE Ion selective electrode
IVD In vitro Diagnostic Directive
L
LCD Liquid cristal display
LIS Laboratory Information System
LJ Levey Jennings
M
MAC Media Access Control
MC Measuring chamber
MSDS Material safety data sheet
MSS Metabolite sensitive sensor
MV Mean value
P
PP Peristaltic pump
Q
QC Quality control
R
RCon Reference contact
REF Reference solution
S
SIP Sample inlet path
SDC Sample distributor cartridge
S1 S1 Rinse Solution
S2 S2 Fluid Pack
S3 S3 Fluid Pack
SCon Sensor contact
SD Standard deviation
SO
T
2
Oxygen saturation
T&D Turn & dock
tHb Total hemoglobin
U
UL Underwriters Laboratories Inc.
V
VDE Association of German Electrical Engineers (Verband Deutscher
Elektrotechniker)
e
For writing the measuring, calculated and input values see Chapter 9 Softwaremodi >
Parameter on page B-75!
Roche Diagnostics April 2009
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cobas b 221 system
Roche Diagnostics April 2009
10 Instructions for Use · Revision 10.0
Introduction and specifications
1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
2 General descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
3 Installation and shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25
4 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-57
5 Theoretical foundations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-95
A
cobas b 221 system 1 Safety information
Contents
Safety information
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
Important information ...................................................................................................5
Operating safety information .........................................................................................6
Chapter
1
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1 Safety information cobas b 221 system
Contents
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cobas b 221 system 1 Safety information
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 (low, normal, high) after each electrode exchange, after each exchange
of solutions and packs and after startup of the instrument.
Additionally complete a quality control test on one level between two automatic 2P
calibrations. The level have to be alternated (low, normal, high).
Since the measurements of the instrument depend not only on the correct
characteristic function, but also on a series of marginal conditions (e.g. pre-analysis),
results obtained from the instrument should be submitted for an expert opinion
before taking additional measures based on the supplied measurements.
Caution (refer to accompanying documents)!
Please refer to safety-related notes in the manual accompanying this instrument.
Roche Diagnostics April 2009
Instructions for Use · Revision 10.0 A-5
1 Safety information cobas b 221 system
Operating safety information
Operating safety information
The instrument has been constructed and tested according to the following European
Standards:
o IEC/EN 61010-1
o IEC/EN 61010-2-101
o IEC/EN 61010-2-081 + A1
It was delivered from the factory in flawless condition with regards to safety features.
In order to preserve this condition and ensure safe operation, the user must respect
the notices and warnings that are contained in these Instructions for Use.
o This equipment is a Class I laser product, and it complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J (only valid for
cobas b 221<1> system, cobas b 221<3> system and cobas b 221<5> system with
tHb/SO
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.
module).
2
o
The power cord must be plugged into a grounded power receptacle. When using an extension
cord, make sure it is properly grounded.
o
Any rupture of the ground lead inside or outside the instrument or a loose ground connection
may result in hazardous operating conditions for the operating personnel. Intentional
disconnection of the grounding is not permitted.
o
The instrument is not suitable for operation with a direct current power supply. Use only the
original power plug delivered with the cobas b 221 system.
o
The use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
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cobas b 221 system 2 General descriptions
Contents
General descriptions
This chapter contains a general description of the instrument, as well as
precautionary measures against special dangers and the proper handling of sensors,
solutions and the MSS cassette.
In this chapter
Introduction ....................................................................................................................9
General notes .................................................................................................................11
Application area .......................................................................................................11
Operating instructions ............................................................................................ 11
Important buttons on the screen ............................................................................ 12
Measurement and calibration procedure ..................................................................... 13
Measurement procedure .........................................................................................13
Calibration procedure ............................................................................................. 13
Measurement evaluation ...............................................................................................14
Safety instructions for specific dangers ........................................................................ 14
Handling samples .................................................................................................... 14
Disposal of waste water, bottles, packs, electrodes and the instrument ...............14
Decontamination ....................................................................................................14
Handling solutions ........................................................................................................ 15
Handling electrodes ......................................................................................................15
General notes on the use of the MSS cassette ..............................................................16
MSS cassette removed from the measuring chamber ............................................ 16
Incompatible substances ......................................................................................... 16
Inserting the MSS cassette ......................................................................................17
System description ........................................................................................................ 18
Visual identification ................................................................................................ 18
Screen/PC unit ......................................................................................................... 19
Printer ......................................................................................................................19
Measuring chamber .................................................................................................19
tHb/SO
COOX module .........................................................................................................20
Pumps ......................................................................................................................20
Input unit ................................................................................................................. 20
module .....................................................................................................19
2
Chapter
2
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2 General descriptions cobas b 221 system
Contents
Bottle compartment ................................................................................................20
Reverse side .............................................................................................................. 21
Power supply ...................................................................................................... 21
Interfaces ............................................................................................................22
Barcode scanner ................................................................................................. 23
Warning and identification labels (incl. nameplate) .......................................24
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cobas b 221 system 2 General descriptions
Introduction
Introduction
Figure A-1 cobas b 221 system
The cobas b 221 system is an analyzer with integrated AutoQC drawer option.
Depending on combination and configuration, the following parameters can be
measured in whole blood, serum, plasma, acetate and bicarbonate containing dialysis
solutions and QC materials:
o pH
o Blood gas BG (PO
o Electrolyte ISE (Na
, PCO2)
2
+
, K+, Cl–, Ca2+)
o Hematocrit (Hct)
o Metabolite MSS
Urea/BUN - only cobas b 221<6> system
o To t al h em og lo b in ( tH b)
o Oxygen saturation (SO
o Hemoglobin derivative COOX (O
)
2
Hb, HHb, COHb, MetHb)
2
o Bilirubin (neonatal)
The following configurations are available:
o cobas b 221<1> system
(a)
BG, pH, tHb/SO
2
o cobas b 221<2> system BG, pH, COOX, Bili
o cobas b 221<3> system
(a)
BG, pH, ISE, Hct, tHb/SO2
o cobas b 221<4> system BG, pH, ISE, Hct, COOX, Bili
o cobas b 221<5> system
(a)
BG, pH, ISE, Hct, MSS, tHb/SO
2
o cobas b 221<6> system BG, pH, ISE, Hct, MSS, COOX, Bili
(a) are no longer manufactured or offered.
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2 General descriptions cobas b 221 system
Introduction
During the measurement or calibration or other processes, it is possible to conduct
database operations, perform certain settings or call up general information at the
same time.
e
For details see Chapter 9 Software modes
The individual, mutually independent software modes are defined as follows:
o Analyzer Measuring, QC measurement, system, calibration,
commonly used functions (quick access)
o Setup Instrument settings
o Database Data about patients, measurements, calibrations, QC, and
the instrument
o Info
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cobas b 221 system 2 General descriptions
General notes
General notes
Application area
The instrument has been tested for measuring parameters in whole blood, serum,
plasma and dialysis solutions (electrolytes only) and the validity of measurements was
tested accordingly.
In order to achieve accurate measurements of recommended aqueous control
solutions (with regards to deviations from biological samples), choose the proper
components and make the corresponding corrections in the QC measurement mode.
The accuracy of measurement values of undefined aqueous solutions cannot be
guaranteed (e.g. due to the possibility of interfering components and/or missing or
insufficient buffer systems, and/or differences in ionic strength and diffusion
potential when compared to biological samples).
Operating instructions
The cobas b 221 system should be switched on at all times!
If the instrument is switched off for an extended period of time (more than 24 hours),
a shutdown must be performed.
e
For additional information, see Chapter 3 Installation and shutdown, section Installation
on page A-27 and Shutdown on page A-48.
Prevent any other liquids from entering the instrument except samples and
QC material at the fill port.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each exchange
of solutions and packs and after startup of the instrument.
Additionally complete a quality control test on one level between two automatic
2P calibrations. The level have to be alternated (low, normal, high).
e
For additional information, see Chapter 7 Quality control.
With Software V 6.0 onwards, using cobas bge link, the instrument can be monitored
from one location, any disturbances can be remedied and the analytical quality
monitored.
cobas bge link is a remote monitoring and remote maintenance software for Roche
Point-of-Care analyzers.
e
see Figure A-2 on page A-12!
Roche Diagnostics April 2009
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2 General descriptions cobas b 221 system
General notes
B
A
A "Screen sharing" Symbol B "Screen sharing" active
Figure A-2
Confirm the message with [OK] either on the instrument or on the PC. The "screen
sharing" symbol is added in the status line.
To avoid multiple operation of the instrument, the message "Screen sharing active" is
displayed with a yellow background in the error and message window of the
instrument.
As long as the "screen sharing" symbol is displayed in the status line, the service connection is
active. In order to prevent multiple operation of the instrument, no buttons on the screen should be
pressed!
Important buttons on the screen
Buttons Description
"Analyzer" active / inactive
"Database" active / inactive
"Setup" active / inactive
"Info" active / inactive
e
For additional information, see Chapter 9 Software modes, section Buttons on page B-76.
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cobas b 221 system 2 General descriptions
Measurement and calibration procedure
Measurement and calibration procedure
Measurement procedure
PO2: Use of the Clark measurement principle: measurement of current generated by
the reduction of oxygen.
PCO
: Use of the Severinghouse principle: potentiometric measurement of the pH
2
change in the electrode caused by CO
pH- , Na
+
-,K+-, Ca2+- und Cl- electrodes are potentiometric electrodes. Special
glasses are used as the sensitive element for pH and Na
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 H
is determined amperometrically by using manganese dioxide/
2O2
carbon electrode at 350 mV.
.
2
+
. The potassium and calcium
Calibration procedure
Oxygen (O
PCO
, pH, ISE: are calibrated using two solutions mixed under different conditions, thereby avoiding
2
): Ambient air and a zero point solution are used to calibrate oxygen.
2
MSS: The calibration is carried out with four (Glu, Lac) or five solutions (Urea/BUN)
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/SO
: Light absorption in whole blood is measured at four different wavelengths,
2
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.
tHb and SO2 was calibrated when the instrument was manufactured.
the gas supply which is required by other instruments.
whose weighing concentrations form the basis for measured value determination.
COOX: Determining the hemoglobin derivatives and the total bilirubin (= neonatal) are
carried out spectral-photometrically using a cuvette.
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2 General descriptions cobas b 221 system
Measurement evaluation
Measurement evaluation
The validity of the test results from the cobas b 221 system must be carefully
examined by a clinical-medical specialist who will take the patient's clinical condition
into consideration before any clinical decisions are reached based on the test results.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each exchange
of solutions and packs and after startup of the instrument.
Additionally complete a quality control test on one level between two automatic 2P
calibrations. The level have to be alternated (low, normal, high).
e
For detailed information, see Chapter 7 Quality control.
Safety instructions for specific dangers
Handling samples
While handling samples, all necessary regulations concerning hygiene must be
observed. Dangerous pathogenic agents could be present.
e
For more detailed information, see Chapter 6 Measurement
Disposal of waste water, bottles, packs, electrodes and the instrument
Dispose of waste water, bottles, packs, electrodes and the instrument according to local and/or labor
regulations (biologically contaminated—hazardous waste!).
Decontamination
The purpose of this decontamination is to minimize risk when handling items that
were in contact with biological samples.
Roche recommends following a decontamination procedure in addition to
regulations specific to the laboratory.
These decontamination procedures should be performed periodically to minimize the
risk of infections.
Always wear gloves!
e
For more detailed information about decontamination, see Chapter 10 Maintenance
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cobas b 221 system 2 General descriptions
Handling solutions
Handling solutions
Store the cobas b 221 system wash/calibrating solutions according to the specified
packaging requirements. The temperature of the solutions should be adapted to the
ambient temperature before use.
The shelf life of the solutions is limited.
Please read the bottle label and the packaging for the correct storage temperature and
the maximum shelf life.
DO NOT FREEZE!
If frozen, the solution's concentration may change and cause calibration errors!
Do not use damaged fluid packs (S2 and S3)! Do not mix the individual components!
e
For "Storage specifications", see Chapter 4 Specifications.
Handling electrodes
Store the electrodes according to the packaging specifications.
The shelf life of the electrodes is limited.
Please read the label and the packaging for the correct storage temperature and the
maximum shelf life.
CAUTION! Installation note for the PCO2 electrode
Insert the electrode into the measuring chamber within 5 minutes of opening the ALU-PE
packaging.
A special protective gas atmosphere designed to condition the PCO2 electrode during storage is
found inside the ALU-PE packaging.
This gas atmosphere ensures immediate potential stability during insertion of the electrode into the
measuring chamber and immediate readiness for measuring the first 2 point calibration.
If more than 5 minutes elapse after opening the ALU-PE packaging, the level of gas conditioning
could be lost and the time required for the first-time calibration could be increased.
e
For "Storage specifications", see Chapter 4 Specifications.
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2 General descriptions cobas b 221 system
General notes on the use of the MSS cassette
General notes on the use of the MSS cassette
For instrument versions with MSS module only!
Attention:
MSS cassette may only be brought into contact with liquids in the cobas b 221 system while
electrodes are changed!
Replace the MSS cassette within 28 days of installation!
After initial contact with liquids, the MSS cassette may no longer be removed from the instrument.
It may lead to the destruction of the enzyme sensors.
Storage:
At 2 – 8 °C, maximum of 2 weeks at room temperature.
MSS cassette removed from the measuring chamber
Once an MSS cassette is exposed to liquid, it must not be allowed to dry out under
any circumstances since this would destroy the enzymes. The enzymes are equipped
with a special protectant prior to shipping for transportation purposes. This
protectant is washed out inside the instrument during the warm-up phase and MSS
polarization.
Incompatible substances
The following substances may not be introduced into the MSS measuring chamber
under any circumstances since they would immediately destroy the MSS sensors or
severely impact their functionality.
o Deproteinizer (NaOCl)
o O
o Cleaning solution
o Na electrode conditioning solution
o Rinse additive
o Solutions containing heavy metals (Ag, Hg, Au, etc., e.g. Thiomersal)
o Cleaning solutions containing detergent (e.g. washing material or liquid
o All solutions for disinfections (e.g. high-percentage alcohol, glutaric dialdehyde,
o Solutions with pH values that deviate greatly from neutral
zero point solution
2
detergents)
cresol, etc.)
(e.g. pH value of < 6.0 and > 9.0)
The use of anticoagulants other than those approved by Roche Diagnostics
(approved: heparin salts), such as EDTA, citrate, NH4 heparin and glycolysis
inhibitor such as NaF and oxalate can lead to erroneous results.
Roche Diagnostics April 2009
A-16 Instructions for Use · Revision 10.0
cobas b 221 system 2 General descriptions
General notes on the use of the MSS cassette
Inserting the MSS cassette
Hold the MSS cassette only at the designated handle and avoid touching the contacts.
e
For a detailed description see Chapter 10 Maintenance, section Changing the MSS cassette
(cobas b 221<5> system and cobas b 221<6> system only) on page C-32.
Roche Diagnostics April 2009
Instructions for Use · Revision 10.0 A-17
2 General descriptions cobas b 221 system
System description
System description
Visual identification
For example: cobas b 221<6> system
P
A
O
N
B
C
D
D
E
A Screen/PC unit
B Reverse side
C Docking mechanism
D AutoQC drawer
E Barcode scanner
F W Waste container
Figure A-3 cobas b 221<6> system
G S1 Rinse Solution
H S2 Fluid Pack
I S3 Fluid Pack
J Bottle compartement cover
K Bottle compartement
L COOX module (tHb/SO
F G H I
module)
2
M
L
K
J
M Input unit
N Measuring chambers
O Printer
P Pumps
Roche Diagnostics April 2009
A-18 Instructions for Use · Revision 10.0
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