Roche Diagnostics Limited
cobas b 221 Instructions for Use Ver 10.0 April 2009
Instructions for Use
330 Pages
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cobas b 221 system Instructions for Use
COBAS, COBAS B and LIFE NEEDS ANSWERS are trademarks of Roche. ©2009 Roche Diagnostics Roche Diagnostics GmbH D-68298 Mannheim Germany www.roche-diagnostics.com
cobas b 221 system
Revision History Manual Version
Software Version
Revision date
Changes
2.0
1.0
May 2003
Launch not delivered
3.0
1.0
June 2003
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
8.0
6.0
December 2006
9.0
7.0
February 2008
10.0
>7.0
April 2009
cobas Branding
Edition notice cobas b 221 system In the course of 2006 the Roche OMNI S system was relaunched under the Roche Diagnostics professional IVD user brand cobas®. Systems with a serial number of 5001 or above are cobas b 221 systems. Systems with a serial number up to 5000 are Roche OMNI S systems. Every effort has been made to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development. Any customer modification to the instrument will render the warranty or service agreement null and void. Software updates are done by Roche Service representatives.
Copyright © 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 Instructions for Use · Revision 10.0
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cobas b 221 system
Brands COBAS, COBAS B, LIFE NEEDS ANSWERS, ROCHE OMNI, AUTOQC, ROCHE MICROSAMPLER, COMBITROL and AUTO-TROL are trademarks of Roche.
Contact addresses Manufacturer
Roche Diagnostics GmbH D-68298 Mannheim / Germany www.roche.com
Edition Revision 10.0, April 2009 First edition: May 2003 REF/No. 03261395001
Roche Diagnostics 2
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cobas b 221 system
Table of contents Revision History Edition notice Copyright Brands Contact addresses Edition Table of contents Preface How to use this manual Where to find information Conventions used in this manual
Introduction and specifications
1 1 1 2 2 2 3 5 5 5 5
Part A
1 Safety information
Important information Operating safety information
A-5 A-6
2 General descriptions
Introduction General notes Measurement and calibration procedure Measurement evaluation Safety instructions for specific dangers Handling solutions Handling electrodes General notes on the use of the MSS cassette System description
A-9 A-11 A-13 A-14 A-14 A-15 A-15 A-16 A-18
3 Installation and shutdown
Installation Shutdown
A-59 A-86 A-86 A-87 A-87 A-88 A-89 A-91 A-92 A-92 A-93 A-94
5 Theoretical foundations
Parameters and calculations Clinical significance
Roche Diagnostics Instructions for Use · Revision 10.0
Part B
6 Measurement
Preanalytics Interferences Limitations of clinical analysis Measuring procedure
B-5 B-10 B-17 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 8 Calibration
Calibration - general Automatic calibrations User-activated calibrations Display of parameters during calibration
B-65 B-65 B-66 B-68
9 Software modes
A-27 A-48
4 Specifications
Performance data Sample throughput Measurement times of the samples Sample volumes Sample types Calibrations Environmental parameters Product data AutoQC Printer Touch screen-PC unit Barcode scanner
Operation
A-97 A-109
Software modes - general User interface Analyzer mode Setup Data manager Info
Maintenance
B-71 B-71 B-78 B-80 B-81 B-87
Part C
10 Maintenance
Maintenance - general Decontamination Daily Weekly Quarterly Sample-dependent maintenance procedures Unscheduled Additional maintenance procedures
C-5 C-5 C-7 C-8 C-9 C-13 C-22 C-38
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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 Glossary
Index Index
Roche Diagnostics 4
E-5 E-9
Part F 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
Cross-reference
h
Call up of screen Note
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Symbol
Used for Caution
All sections / passages that are marked with this symbol describe procedures and/or indicate conditions or dangers that could damage or lead to a malfunction in the cobas b 221 system, and which therefore should never be attempted and contain information that must be observed to avoid potential injuries (to patients, users and third parties). Risk of infection
All sections and parts of texts that are marked with this symbol describe procedures that may involve risk of infection.
IVD symbols
The symbols are used in accordance with DIN EN 980(a) and DIN EN ISO 780(b). Symbol
Description
Conformité Européenne: This product complies with the requirements in the guideline for In Vitro Diagnostic 98/79/EC. Lot designation Use by... The product should not be used after expiry of the specified date. If a day is not indicated, apply the last day of the respective month. Temperature limitation The conditions necessary to preserve the product's shelf life before opening. In Vitro Diagnostic Medical Device Manufacturer (according to In Vitro Diagnostic guidelines 98/79/EG) Catalogue number
Serial number (model plate)
Caution, consult accompanying documents
Please consult instructions for use
(a) DIN EN 980: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (Part 1: General requirements) (b) DIN EN ISO 780: Packaging - Pictorial marking for the handling of goods
Roche Diagnostics 6
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Symbol
Description
Biological risk! (according to the standard IEC/EN 61010-2-101)(a) (Instrument) Biological risk! (according to the standard DIN EN ISO 980)(b) (Consumables)
Do not use if package damaged
Do not reuse
Fragile. Handle with care
Handle with care
Valid only for Roche MICROSAMPLER:
Method of sterilization using ethylene oxide Valid only for BS2 Blood Sampler:
Method of sterilization using irradiation (a) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control, and laboratory use - (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment). (b) DIN EN ISO 980: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (Part 1: General requirements).
Other symbols
The following symbols are listed as additional information: Symbol
Description
Electrodes: This date indicates the limit of the maximum storage time of an electrode. The electrode must be installed in the instrument no later than the imprinted date. If the installation takes place on the imprinted date, it still falls within the specifications. The calculation of the “Install before” date is based on the production date of the elctrode. Danger symbol: "Irritant" (on the label and the packaging of S2 Fluid Pack) Rating: Although not corrosive, momentary, longer-lasting, or repeated contact with skin or mucous membrane may result in inflammation. Danger of sensitization during contact with skin (when classified with R 43). Caution: Avoid contact with eyes and skin, do not inhale vapors.
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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: 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
Roche Diagnostics 8
Hct
Hematrocrit
HIV
Human immunodeficiency virus
HW
Hardware
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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
SO2
Oxygen saturation
T
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!
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Roche Diagnostics 10
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Introduction and specifications
A
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
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
Chapter
1
Important information ... 5 Operating safety information ... 6
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cobas b 221 system
Contents
Roche Diagnostics A-4
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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.
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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.
Roche Diagnostics A-6
o
This equipment is a Class I laser product, and it complies with FDA Radiation Performance Standards, 21 CFR Subchapter J (only valid for cobas b 221<1> system, cobas b 221<3> system and cobas b 221<5> system with tHb/SO2 module).
o
This instrument is classified under the protection class I according to IEC /EN 61010-1.
o
The instrument meets the conditions for overvoltage category II.
o
The instrument meets the conditions for contamination level 2.
o
Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide.
o
If objects or liquids enter the internal areas of the instrument, remove the instrument from its power supply and allow an expert to check it thoroughly before using it again.
o
The instrument is suitable for long-term operation indoors.
o
The power cord must be plugged into a grounded power receptacle. When using an extension cord, make sure it is properly grounded.
o
Any rupture of the ground lead inside or outside the instrument or a loose ground connection may result in hazardous operating conditions for the operating personnel. Intentional disconnection of the grounding is not permitted.
o
The instrument is not suitable for operation with a direct current power supply. Use only the original power plug delivered with the cobas b 221 system.
o
The use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
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cobas b 221 system
2 General descriptions Contents
General descriptions
This chapter contains a general description of the instrument, as well as precautionary measures against special dangers and the proper handling of sensors, solutions and the MSS cassette.
In this chapter
Chapter
2
Introduction ... 9 General notes ... 11 Application area ... 11 Operating instructions ... 11 Important buttons on the screen ... 12 Measurement and calibration procedure ... 13 Measurement procedure ... 13 Calibration procedure ... 13 Measurement evaluation ... 14 Safety instructions for specific dangers ... 14 Handling samples ... 14 Disposal of waste water, bottles, packs, electrodes and the instrument ... 14 Decontamination ... 14 Handling solutions ... 15 Handling electrodes ... 15 General notes on the use of the MSS cassette ... 16 MSS cassette removed from the measuring chamber ... 16 Incompatible substances ... 16 Inserting the MSS cassette ... 17 System description ... 18 Visual identification ... 18 Screen/PC unit ... 19 Printer ... 19 Measuring chamber ... 19 tHb/SO2 module ... 19 COOX module ... 20 Pumps ... 20 Input unit ... 20
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Contents
Bottle compartment ... 20 Reverse side ... 21 Power supply ... 21 Interfaces ... 22 Barcode scanner ... 23 Warning and identification labels (incl. nameplate) ... 24
Roche Diagnostics A-8
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2 General descriptions Introduction
Introduction
Figure A-1
cobas b 221 system
The cobas b 221 system is an analyzer with integrated AutoQC drawer option. Depending on combination and configuration, the following parameters can be measured in whole blood, serum, plasma, acetate and bicarbonate containing dialysis solutions and QC materials: o
pH
o
Blood gas BG (PO2, PCO2)
o
Electrolyte ISE (Na+, K+, Cl–, Ca2+)
o
Hematocrit (Hct)
o
Metabolite MSS
Urea/BUN - only cobas b 221<6> system
o
Total hemoglobin (tHb)
o
Oxygen saturation (SO2)
o
Hemoglobin derivative COOX (O2Hb, HHb, COHb, MetHb)
o
Bilirubin (neonatal)
The following configurations are available: o
cobas b 221<1> system(a)
BG, pH, tHb/SO2
o
cobas b 221<2> system
BG, pH, COOX, Bili (a)
o
cobas b 221<3> system
o
cobas b 221<4> system
BG, pH, ISE, Hct, COOX, Bili
o
cobas b 221<5> system(a)
BG, pH, ISE, Hct, MSS, tHb/SO2
o
cobas b 221<6> system
BG, pH, ISE, Hct, MSS, COOX, Bili
BG, pH, ISE, Hct, tHb/SO2
(a) are no longer manufactured or offered.
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