Instructions for Use
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cobas b 221 system
Instructions for Use
COBAS, COBAS B and LIFE NEEDS ANSWERS are trademarks of Roche. ©2014 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 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
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
cobas Branding
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.
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Copyright
© 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 4
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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
3 3 4 4 4 4 5 7 7 7 7
Introduction and specifications
19 20 21
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
25 27 29 31 32 33 34 35 37
3 Installation and shutdown
Installation Shutdown
45 65
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
79 103 104 105 106 107 108 111 112 112 113 114
5 Theoretical foundations
Parameters and calculations Reference and critical values Roche Instructions for Use · Version 14.0
6 Measurement
Preanalytics Interferences Limitations of clinical analysis Measuring procedure Aspirate from syringe Use as default setup Data input POC mode (Point-of-care mode)
145 151 157 160 163 165 166 171
7 Quality control
1 Safety information
Important information Operating safety information IT Security Advisory
Operation
117 132
Quality control - general General QC concept Important information concerning the analysis of QC measurement results Material setup Material assignment – AutoQC materials QC timing Setting start time(s) Change lot (applies only to AutoQC measurements) Control - on board time Scanning the material code Scanning ranges Checking for AutoQC compatibility QC measurement AutoQC measurement Multirules Overview of the Multirules QC consequences Remove the QC lock Exchange the electrode QC for Ready (with AutoQC module) QC for Ready (without AutoQC module) QC troubleshooting
175 176 178 179 181 184 185 186 188 190 191 192 196 198 199 200 201 202 203 204 206 208
8 Calibration
Calibration - general Automatic calibrations User-activated calibrations Display of parameters during calibration
213 213 214 216
9 Software modes
Software modes - general User interface Parameters/icons Analyzer mode Setup Data manager Info
219 219 221 226 228 229 235 February 2014 5
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Maintenance 10 Maintenance
Maintenance - general Decontamination Daily Weekly Quarterly Sample-dependent maintenance procedures Unscheduled Additional maintenance procedures
247 247 249 250 252 256 265 286
Troubleshooting 11 Troubleshooting
Troubleshooting - general System stops Module stops System warnings Status messages of measuring and calibration values Status messages on the measurement report Barcode
293 294 300 304 308 324 325
Appendix 12 List of consumables
Order information
331
13 Glossary
Index Index
341
Revisions 13 Revisions
Revision
Roche 6
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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 o
cobas b 221 system Reference Manual 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
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Symbols
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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 8
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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).
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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 clothing must be worn. Table 4
Other symbols
Abbreviations The following abbreviations are used: Abbreviation
Definition
A ANSI
American National Standards Institute
AQC, AutoQC
Automatic Quality Control
Table 5 Roche 10
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Abbreviation
ASTM
Definition
American Society for Testing and Material
B BG
Blood gas
BUN
Blood urea nitrogen
C CE
Conformité Européenne
CLIA
Clinical Laboratory Improvement Amendments
CLSI
Clinical and Laboratory Standards Institute
COHb
Carboxyhemoglobin
cond
Conductivity
COOX
CO-Oximetry
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
DIN
German Institute for Standardization
DNS
Domain Name Server
E EC
European community
e.g.
for example
EN
European standard
F FMS
Fluid mixing system
G GB
Gigabyte
Glu
Glucose
H Hct
Hematrocrit
HHb
Desoxyhemoglobin
HIV
Human immunodeficiency virus
HW
Hardware
Hz
Hertz
I i.e.
that is to say
IEC
International Electrotechnical Commission
ISE
Ion selective electrode
ISO
International Organization of Standardization
IVDD
In vitro Diagnostic Directive
K KCl
Potassium chloride
kg
kilogram
L Table 5 Roche Instructions for Use · Version 14.0
Abbreviations February 2014 11
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Abbreviation
Definition
Lac
Lactate
LCD
Liquid crystal display
LED
Light emitting diode
LIS
Laboratory Information System
LJ
Levey Jennings
LoD
Limit of Detection
M MAC
Media Access Control
MB
Megabyte
MC
Measuring chamber
MetHb
Methemoglobin
MHz
Megahertz
MSDS
Material safety data sheet
MSS
Metabolite sensitive sensor
MV
Mean value
N NIST
National Institute of Standards and Technology
NRTL
Nationally Recognized Testing Laboratory
O O2Hb
Oxyhemoglobin
P PCO2
Partial pressure of carbon dioxide
PO2
Partial pressure of oxygen
PP
Peristaltic pump
Q QC
Quality control
R RCon
Reference contact
REF
Reference solution
S SCon
Sensor contact
SD
Standard deviation
SDC
Sample distributor cartridge
SIP
Sample inlet path
SO2
Oxygen saturation
S1
S1 Rinse Solution
S2
S2 Fluid Pack
S3
S3 Fluid Pack
T T&D
Turn & dock
tHb
Total hemoglobin
U USB Table 5 Roche 12
Universal Serial Bus Abbreviations February 2014 Instructions for Use · Version 14.0
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Abbreviation
Definition
V VDE
Association of German Electrical Engineers
W W
Watt
Table 5
Abbreviations
U For writing the measuring, calculated and input values see Software modes (p. 217) > Parameters/icons (p. 221)
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Introduction and specifications
1 2 3 4 5
Safety information ... 17 General descriptions... 23 Installation and shutdown... 43 Specifications ... 75 Theoretical foundations ... 115
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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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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 (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
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1 Safety information
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Operating safety information
Operating safety information The instrument has been constructed and tested according to the following European Standards: o o o
IEC/EN 61010-1(1) IEC/EN 61010-2-101(2) 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
o o o o o
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). This instrument is classified under the protection class I according to IEC/EN 61010-1. The instrument meets the conditions for overvoltage category II. The instrument meets the conditions for contamination level 2. Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide. 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. 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. Roche 20
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1 Safety information IT Security Advisory
IT Security Advisory
Description All devices based on common off-the-shelf operating systems (Microsoft Windows, Linux, etc.) with the capability to connect external storage devices (USB memory drives/sticks, hard disks, floppy disks, CD-ROM, DVS, cameras, PDA, wireless communication devices, etc.) are concerned. This usually applies but is not limited to all products which come with a PC or notebook. External storage media can be infected with and transmit computer malware (e.g. Virus, Trojan Horse, Spyware, etc.) cobas b 221 system does not contain anti-virus protection software. Therefore, it is essential to follow the necessary precautions listed below to prevent the transmission of malware.
Security precautions Warning
r Failure to observe the following recommendations may result in data loss, loss of integrity of patient results or unavailability of the system, which may put patients at risk.
WARNING
o o o
o o o o o o o o
Roche Instructions for Use · Version 14.0
Check all external storage devices with an anti-virus program (on another PC) to ensure that they are malware free before using them on the system. Recheck the external storage device between use on different systems in order to avoid cross-interference. At no time should portable storage media, particularly USB memory drives/sticks, be used at home or at public computer systems and then be used to connect to a work or customer system. Do not use the USB ports to connect other external storage devices unless stated in cobas b 221 system-specific documentation. Keep all external storage devices in a secure place so that they can be accessed only by authorized personnel. Do not add, move or delete any files or software unless stated in cobas b 221 system-specific documentation. Never copy and install any non-Roche software on the system. If a system requires additional software please contact the appropriate system hot line. Use any remote services capability (e.g. cobas® e-support) only to connect to the Roche Service Network. Do not connect to the Internet unless stated in cobas b 221 system-specific documentation. Make sure only validated computers are connected to the instrument system network.
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