cobas b 221 system - Frank's Hospital Workshop

1 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 cobas b 221 system Revision History Manual Version Software Version Revision date Changes May 2003 Launch June 2003 not delivered July 2003. March 2004. December 2004. November 2005. March 2006 cobas Branding December 2006. February 2008. > April 2009. Edition notice cobas b 221 system In the course of 2006 the Roche OMNI S system was relaunched under the Roche Diagnostics professional IVD user brand cobas . Systems with a serial number of 5001 or above are cobas b 221 systems.

2 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.

3 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 1. cobas b 221 system Brands cobas , cobas B, LIFE NEEDS ANSWERS, ROCHE OMNI, AUTOQC, ROCHE MICROSAMPLER, COMBITROL and AUTO-TROL are trademarks of Roche. Contact addresses Manufacturer Roche Diagnostics GmbH. D-68298 Mannheim / Germany Edition Revision , April 2009. First edition: May 2003. REF/No. 03261395001. Roche Diagnostics April 2009. 2 Instructions for Use Revision cobas b 221 system Table of contents Revision History 1.

4 Edition notice 1. Operation Part B. Copyright 1. Brands 2 6 Measurement Contact addresses 2 Preanalytics B-5. Edition 2 Interferences B-10. Table of contents 3 Limitations of clinical analysis B-17. Preface 5 Measuring procedure B-19. How to use this manual 5. Where to find information 5 7 Quality control Conventions used in this manual 5 Quality control - general B-33. General QC concept B-33. Important information concerning the analysis of QC. Introduction and specifications Part A measurement results B-35. Material setup B-36. 1 Safety information QC setup wizard B-44. Important information A-5 QC measurement B-51. Operating safety information A-6 Multirules B-53.

5 QC consequences B-55. 2 General descriptions Remove the QC lock B-56. Introduction A-9 QC for Ready (with AutoQC module) B-57. General notes A-11 QC for Ready (without AutoQC module) B-59. Measurement and calibration procedure A-13 QC troubleshooting B-61. Measurement evaluation A-14. Safety instructions for specific dangers A-14 8 Calibration Handling solutions A-15 Calibration - general B-65. Handling electrodes A-15 Automatic calibrations B-65. General notes on the use of the MSS cassette A-16 User-activated calibrations B-66. system description A-18 Display of parameters during calibration B-68. 3 Installation and shutdown 9 Software modes Installation A-27 Software modes - general B-71.

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

7 Clinical significance A-109. Roche Diagnostics April 2009. Instructions for Use Revision 3. cobas b 221 system Troubleshooting Part D. 11 Troubleshooting Troubleshooting - general D-5. system stops D-5. Module stops D-12. system warnings D-16. Status messages of measuring and calibration values D-20. Status messages on the measurement report D-39. Barcode D-40. Appendix Part E. 12 List of consumables Order information E-5. Glossary E-9. Index Part F. Index F-3. Roche Diagnostics April 2009. 4 Instructions for Use Revision 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.

8 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.

9 This section explains formatting conventions used in this manual. Symbols Helping to locate and interpret information in this manual the following symbols are used: Symbol Used for a Procedural step o List item e Cross-reference h Call up of screen Note Roche Diagnostics April 2009. Instructions for Use Revision 5. cobas b 221 system Symbol Used for Caution All sections / passages that are marked with this symbol describe procedures and/or indicate conditions or dangers that could damage or lead to a malfunction in the cobas b 221 system , and which therefore should never be attempted and contain information that must be observed to avoid potential injuries (to patients, users and third parties).

10 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 Conformit Europ enne: This product complies with the requirements in the guideline for In Vitro Diagnostic 98/79/EC. Lot designation Use 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).