Roche Diagnostics Limited

Blood Gas Testing

cobas b 221 system Instructions for Use Ver 10.0 April 2009

Instruction for Use

330 Pages

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  April 2009 3
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