1 Cobas c111 system Operator's Manual Version cobas c 111. Document information Revision history Manual version Software version Revision date Changes July 2006 First publication. December 2007 Full mode added. Improved calibration concept. Additional maintenance and troubleshooting information. Additions, improvements, and corrections. June 2009 Inventory, processing sequence, and ratio functions added. Improvements and corrections. Layout upgraded. Edition notice The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (HbA1c).
2 It is optimized for small throughput workloads of approximately samples per day, utilizing photometric analysis and an optional unit for ion selective electrodes (ISE). This manual is for users of the cobas c111 instrument. 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 service representatives.
3 Intended use The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (HbA1c). It is important that the operators read this manual thoroughly before using the system . Copyrights 2009, Roche Diagnostics GmbH. All rights reserved. Trademarks The following trademarks are acknowledged: COBAS, COBAS C and LIFE NEEDS ANSWERS are trademarks of Roche. All other trademarks are the property of their respective owners. Roche Diagnostics 2 Operator's Manual Version cobas c111. Instrument approvals The cobas c111 instrument meets the protection requirements laid down in IVD.
4 Directive 98/79/EC and the European Standard EN 591. Furthermore, our instruments are manufactured and tested according to the following international standards: o EN/IEC 61010-1 2nd Edition o EN/IEC 61010-2-101 1st Edition The Operator's manual meets the European Standard EN 591. Regulatory compliance is demonstrated by the following marks: Complies with European Union (EU) Directive 98/79/EC. Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US. C US. Contact addresses Manufacturer Roche Diagnostics Ltd. Forrenstrasse CH-6343 Rotkreuz Switzerland Distributor Roche Diagnostics GmbH. Sandhofer Strasse 116.
5 D-68305 Mannheim Germany Roche Diagnostics Operator's Manual Version 3. cobas c 111. Roche Diagnostics 4 Operator's Manual Version cobas c111. Table of contents Document information 2. Contact addresses 3. Operation Part B. Table of contents 5. Preface 7 6 Daily operation How to use this manual 7 Introduction B 5. Online Help system 7 Starting the shift B 10. Conventions used in this manual 8 Preparing the system B 12. Analyzing samples B 34. Validating sample results B 51. system Description Part A Performing calibrations B 59. Performing QC B 68. 1 Safety Finishing the shift B 77. Safety classification A 5 Logging off B 88.
6 Safety information A 5 Switching off the system B 88. Data security A 10 Using the barcode scanner B 89. License notices A 11. Legal liability A 11 6 Special operations Disposal recommendation A 12 Deleting sample orders B 93. Safety labels A 13 Deleting sample results B 94. Calibration B 95. 2 Introduction to the instrument Deleting QC results B 96. Overview A 17 Lot handling B 98. User interface A 20 Exporting data B 104. Wizards A 21 Importing data B 111. Daily operation A 22 Preparing a new disk B 116. Maintenance A 34 Assigning tests to test tabs B 119. system status A 35 Deleting bottle sets from the Inventory list B 120.
7 Refilling printer paper B 122. 3 Hardware Removing condensation water Covers and panels A 39 from the reagent cooler B 124. LEDs A 41 Replacing the probe B 125. Main components A 43 Connecting and disconnecting the Hardware overview A 44 external fluid containers B 127. Technical specifications A 66 Adjusting the touchscreen B 130. Cleaning the touchscreen B 131. 5 Software Introduction A 71 7 Configuration Screen layout A 72 Introduction B 135. Display items A 73 Applications B 137. Workflows and wizards A 74 Configuration B 157. Working with the user interface A 75. Key screens A 84. Color interpretation for LEDs A 122.
8 Maintenance Part C. Buttons A 124. 8 General maintenance Overview C 5. Maintenance actions C 8. Roche Diagnostics Operator's Manual Version 5. cobas c 111. Troubleshooting Part D Glossary and Index Part F. 9 Messages and alarms Glossary F 3. About messages D 5 Index F 11. Message screen D 5. Acoustic signals D 6. Alarm monitor D 6. Revisions Part G. List of alarm messages D 10. 18 Revisions 10 Result flags About flags D 25. Safety D 27. List of flags D 28. 11 Troubleshooting Introduction D 41. Dealing with exceptional situations D 42. Reacting to messages D 44. Detailed procedures D 46. ISE Part E. 12 ISE description Overview E 5.
9 Hardware E 9. Basic operation E 12. Technical specifications E 13. 13 ISE operation Daily operation E 17. Replacing ISE fluid bottles E 30. Replacing electrodes E 32. Cleaning the ISE tower off the instrument E 36. 14 ISE maintenance Introduction E 41. ISE maintenance actions E 42. 15 ISE troubleshooting Introduction E 69. Safety E 70. List of ISE flags E 71. Reacting to error messages E 80. Roche Diagnostics 6 Operator's Manual Version cobas c111. Preface The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (HbA1c).
10 It is optimized for small throughput workloads of approximately samples per day, utilizing photometric analysis and an optional unit for ion selective electrodes (ISE). This manual describes the cobas c111 features and general operational concepts, and it provides operating, maintenance, and emergency procedures. How to use this manual o Keep this Operator's Manual in a safe place to ensure that it is not damaged and remains available for use. o This Operator's Manual should be easily accessible at all times. To help you find information quickly, there is a table of contents at the beginning of the manual and each chapter.