Rapid Lab 1200 Operators Guide

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Rapidlab® 1200 Systems

Operator’s Guide

02087462 Rev. V, 2010–01


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© 2010 Siemens Healthcare Diagnostics Inc. All rights reserved.

No part of this manual or the products it describes may be reproduced by any means or in any form without

prior consent in writing from Siemens Healthcare Diagnostics.

The Rapidlab 1200 systems are for in vitro diagnostic use.

AutomaticQC, Rapidlab, Rapidlink, Rapidcomm, RapidQC, Quick, CompleNet, RapidSystems, and

Multicap are trademarks of Siemens Healthcare Diagnostics.

Windows is a trademark of Microsoft Corporation.

IBM is a trademark of International Business Machines Corporation.

Origin: UK

The information in this operator’s guide was correct at the time of printing. However, Siemens continues to

improve products and reserves the right to change specifications, equipment, and maintenance procedures at

any time without notice.

If the system is used in a manner differently than specified by Siemens, the protection provided by the

equipment may be impaired. See warning and hazard statements.


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Using This Guide

The Rapidlab® 1200 Systems Operator’s Guide provides information for thefollowing clinical laboratory professionals who use the Rapidlab1200 system:

• Routine operators

These are medical or laboratory personnel who use the Rapidlab 1200systems to analyze patient and QC samples, to view and print results, and to perform routine maintenance.

• System supervisors

These are laboratory supervisors or designated key operators who performSetup functions, monitor the use of the Rapidlab 1200 systems, and assistwith troubleshooting and maintenance when necessary.

Organization

The following table describes how this operator’s guide is organized.

If you want to... Then refer to...

learn about system features,learn about the hardware,learn about user interface components,learn about principles of potentiometry,

Section 1:System Features

Hardware Overview,

Software Overview,

Technology.

process samples, monitor status, or manage sampleresults, Section 2:Operating the System.

calibrate the system, Section 3:Calibration.

learn about QC options,analyze QC samples,

Section 4:Quality Control.

perform scheduled maintenance activities,record maintenance activities,

Section 5: Maintenance.

investigate and correct system problems, Section 6: Troubleshooting.

manage data files, Section 7: Data Management.

modify test definition parameters,modify system parameters,set up LIS parameters,

Section 8:System Configuration.

learn about biohazard precautions,learn about laser precautions,

Appendix A:Safety.


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Conventions

The Rapidlab® 1200 Operator’s Guide uses the following text and symbol conventions:

find warranty, legal, and support information,find contact information,

Appendix B:Warranty and Support

Information.

learn about fill volume and stability information aboutsystem fluids,

Appendix C:System Fluids.

find information about ordering supplies, Appendix D:Ordering Supplies.

learn about system specifications, Appendix E:System Specifications.

learn about system symbols, Appendix F:Symbols.

learn about system terms, Appendix G:Glossary.

Convention Description

BIOHAZARD: Biohazard statements alert you to potentially biohazardous conditions.

LASER WARNING: Laser Warning statements alert you to the risk ofexposure to lasers.

WARNING: Warning statements alert you to conditions thatmay cause personal injury.

CAUTION: Caution statements alert you to conditions that maycause product damage or loss of data.On the system, this symbol indicates that youshould refer to the operator’s guide for moreinformation.

NOTE: Note statements alert you to important informationthat requires your attention.

Bold Bold type indicates commands on the userinterface, keys, or the exact text that an operator

needs to type.For example, if the word save is displayed as Save,it refers to the selecting the Save button on the userinterface.Another example is typing a specific entry into atext box. If the word welcome is displayed aswelcome, it means that you should type that wordinto the specified field.

If you want to... Then refer to...


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Terminology

The following table explains some of the special terminology used in thisoperator’s guide and the specific actions that you need to take when you see theterminology:

Italic Italic type refers to the title of a document or asection title in this operator’s guide. For example,Operating the System‚ page 2-1 refers to Section 2

of this operator’s guide.

Term Description

Select To select an item, use your finger to select the item on the touchscreenmonitor.

Enter Use the numeric or alphanumeric sections of the touchscreen to enter thespecified information.

Scan Move the hand-held barcode scanner over the specified barcode to enterthe information.

Convention Description


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Contents

Using This Guide

Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-i

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii

Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iii

1 System Overview and Intended Use

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

User Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 AutomaticQC Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

AutomaticQC Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Waste Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Reagent Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Reagent Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

Wash Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13Wash Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13

Measurement Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 CO-ox Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19Rapidlab® User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Viewing the Banner Information. . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20

Viewing the Display Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Rapidlab Main System Screens . . . . . . . . . . . . . . . . . . . . . . . . 1-21 Analysis Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Recall Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Rapidlab 1200 Systems Sample Path . . . . . . . . . . . . . . 1-25

System Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25 CO-ox Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Rapidlab 1200 Systems Technology . . . . . . . . . . . . . . . 1-27

Potentiometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27 Reference Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-31

Amperometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 pH and Blood Gases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

Hydrogen Ion Activity or pH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33


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Carbon Dioxide Tension ( pCO2 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35

Oxygen Tension (pO2 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38

Electrolytes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40 Concentration of Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42

Concentration of Potassium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42 Concentration of Chloride. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43

Concentration of Ionized Calcium. . . . . . . . . . . . . . . . . . . . . . . . . . 1-44

Metabolites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45 Concentration of Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45

Concentration of Lactate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-46

Glucose and Lactate Biosensors . . . . . . . . . . . . . . . . . . . . . . . . . . 1-46

Hemoglobin and its Derivatives . . . . . . . . . . . . . . . . . . . . . . . . 1-48 Total Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49

Oxyhemoglobin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49

Deoxyhemoglobin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49

Methemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50 Carboxyhemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50

Sulfhemoglobin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50

Determination of Hemoglobin Derivatives . . . . . . . . . . . . . . . . . . . 1-51

CO-oximeter Measurement Technology. . . . . . . . . . . . . . . . . . 1-51

Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-52

Bicarbonate Ion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54Base Excess. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54Total Carbon Dioxide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 Hematocrit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 Patient Temperature Correction . . . . . . . . . . . . . . . . . . . . . . . . 1-56

Hemoglobin Oxygen Saturation . . . . . . . . . . . . . . . . . . . . . . . . 1-56 Oxygen Content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-56

Oxygen Content of Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-57

Oxygen Capacity of Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . 1-57

p50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-58

Oxygen Saturation (Estimated). . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-58

pO2 /F I O2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59

Calcium Adjustment for pH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59 Anion Gap. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59Gas Exchange Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 Alveolar-Arterial Oxygen Tension Difference . . . . . . . . . . . . . . 1-60 Arterial-Alveolar Oxygen Tension Ratio . . . . . . . . . . . . . . . . . . 1-60 Respiratory Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61 Arterial-Venous (a-v) Study . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61

Arterial Oxygen Content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61

Mixed Venous Oxygen Content . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61

Arterial-Venous Oxygen Content Difference. . . . . . . . . . . . . . . . . . 1-62

a-v Extraction Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-62


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Oxygen Consumption Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-62

Oxygen Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-62

Physiologic Shunt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-63

Estimated Shunt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-63

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-65

2 Operating the System

Using Basic System Functions . . . . . . . . . . . . . . . . . . . . 2-1

Starting up the Rapidlab 1200 System . . . . . . . . . . . . . . . . . . . . 2-1Entering Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Replacing Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Emptying the Waste Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Replacing the Wash Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Replacing the Reagent Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Replacing the AutomaticQC Cartridge. . . . . . . . . . . . . . . . . . . . . . . .2-3Reinstalling the AutomaticQC Cartridge . . . . . . . . . . . . . . . . . . . . . .2-4

Accessing System Information . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Accessing Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Collecting Patient Samples. . . . . . . . . . . . . . . . . . . . . . . . 2-7

Collecting Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Using Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Using Different Sample Sources. . . . . . . . . . . . . . . . . . . . . . . . . 2-8 Handling and Storing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9Understanding System Limitations . . . . . . . . . . . . . . . . . . . . . . 2-10

Analyzing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Analyzing Syringe Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11 Analyzing Capillary Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Analyzing Microsamples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Analyzing pH and pH, Glu, and Lac Samples. . . . . . . . . . . . . . 2-17 Analyzing tHb Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 Using Custom Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

Understanding System Behavior with Custom Panels. . . . . . . . . . .2-21

Entering Patient Sample Data. . . . . . . . . . . . . . . . . . . . . 2-22

Scanning Barcodes at the Analysis Screen . . . . . . . . . . . . . . .2-22

Scanning Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22 Entering Patient Demographics . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Early Demographics Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . .2-24

Using the Save Demographics Option. . . . . . . . . . . . . . . . . . . . . . .2-25

Editing Demographics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Using Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27


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Viewing Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27 Performing a Patient Search . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Patient Search Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Performing a Patient Search. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Recalling Patient Sample Results . . . . . . . . . . . . . . . . . . . . . . 2-30 Interpreting the Patient Recall Screen Symbols . . . . . . . . . . . . . . . 2-30

Printing Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

Procedural Notes for Printing Reports . . . . . . . . . . . . . . . . . . . 2-31Printing Reports on the Internal Printer . . . . . . . . . . . . . . . . . . . . . 2-31

Printing Reports on the External Printer . . . . . . . . . . . . . . . . . . . . . 2-32

Using Available Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32

Performing a Correlation Study . . . . . . . . . . . . . . . . . . . 2-34

Combining Results for an a-v Study Report . . . . . . . . . 2-35

Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36

Setting up the Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36 Printing the Arterial-Venous Study Report . . . . . . . . . . . . . . . . . . . 2-37

3 Calibration

Understanding Automatic Calibrations . . . . . . . . . . . . . . 3-1

Troubleshooting Failed Calibrations . . . . . . . . . . . . . . . . . . . . . . 3-3Generating Calibration Reports . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Performing Manual Calibrations . . . . . . . . . . . . . . . . . . . . 3-4

Recalling Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

4 Quality Control

Performing QC Sample Analysis. . . . . . . . . . . . . . . . . . . . 4-1

Using the Required QC Analysis Option . . . . . . . . . . . . . . . . . . 4-1Performing Required QC Sample Analysis. . . . . . . . . . . . . . . . . . . . 4-1

Procedural Notes for Required QC. . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Using the AutomaticQC Analysis Option . . . . . . . . . . . . . . . . . . 4-3Performing AutomaticQC Sample Analysis . . . . . . . . . . . . . . . . . . . 4-3

Manually Performing AutomaticQC Analysis . . . . . . . . . . . . . . . . . . 4-3

Procedural Notes for AutomaticQC Sample Analysis . . . . . . . . . . . . 4-4

Performing STAT Samples during AutomaticQC Analysis . . . . . . . . 4-4Using the Unscheduled QC Option . . . . . . . . . . . . . . . . . . . . . . 4-4Performing Unscheduled QC Sample Analysis . . . . . . . . . . . . . . . . 4-4

Accessing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Printing or Sending Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Result Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Recalling QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7


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Using the QC List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Using the Recall QC Data Search Screen. . . . . . . . . . . . . . . . . . . . .4-8

Using the Recall–QC Statistics Screens. . . . . . . . . . . . . . . . . . . 4-9Viewing the Recall–QC Statistics Screen . . . . . . . . . . . . . . . . . . . . .4-9

Using the Recall–Levey-Jennings Screens . . . . . . . . . . . . . . . 4-11Viewing the Recall–Levey-Jennings Graph Screen. . . . . . . . . . . . .4-11

Restoring Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

5 Maintenance

Preparing for Maintenance Procedures. . . . . . . . . . . . . . 5-1

Performing Daily Maintenance . . . . . . . . . . . . . . . . . . . . . 5-2

Checking System Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Cleaning and Disinfecting the Exterior Surfaces . . . . . . . . . . . . 5-2

Calibrating the Barometric Sensor . . . . . . . . . . . . . . . . . . . . . . . 5-3Performing Twice Weekly Maintenance. . . . . . . . . . . . . . 5-3

Analyzing High G/L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Performing Weekly Maintenance . . . . . . . . . . . . . . . . . . . 5-4

Deproteinizing the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . 5-4Conditioning the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Checking the Level of Fill Solution . . . . . . . . . . . . . . . . . . . . . . . 5-7

Performing Every 60 Days Maintenance . . . . . . . . . . . . . 5-9

Replacing the CO-ox Sample Chamber . . . . . . . . . . . . . . . . . . . 5-9Checking the Air Filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Performing Quarterly Maintenance . . . . . . . . . . . . . . . . 5-10 Replacing the Pinch Valve Tubing . . . . . . . . . . . . . . . . . . . . . . 5-10

Testing for Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11

Yearly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Replacing the Measurement Module Tubing . . . . . . . . . . . . . . 5-12 Replacing the CO-ox Module Tubing . . . . . . . . . . . . . . . . . . . . 5-13

Replacing the CO-ox Sample Tubing . . . . . . . . . . . . . . . . . . . . . . .5-14

Replacing the CO-ox Waste Tubing . . . . . . . . . . . . . . . . . . . . . . . .5-15

Replacing the CO-ox Pump Tubing. . . . . . . . . . . . . . . . . . . . . . . . .5-16

Completing CO-ox Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16

Replacing the Reagent Manifold. . . . . . . . . . . . . . . . . . . . . . . . 5-17 Completing Reagent Manifold Maintenance . . . . . . . . . . . . . . . . . .5-18

Replacing the AutomaticQC Manifold. . . . . . . . . . . . . . . . . . . . 5-19Completing AutomaticQC Manifold Maintenance . . . . . . . . . . . . . .5-20

Replacing the Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

Cleaning Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

Cleaning and Disinfecting the Screen. . . . . . . . . . . . . . . . . . . . 5-21


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Cleaning the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22 Reinstalling the Reference Sensor and Biosensors . . . . . . . . . . . . 5-24

Completing the Sample Path Maintenance . . . . . . . . . . . . . . . . . . 5-24

Cleaning the CO-ox Roller Cage . . . . . . . . . . . . . . . . . . . . . . . 5-25

Cleaning the Roller Cage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26 Reinstalling the Roller Cage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26

Reconnecting the CO-ox Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27

Cleaning the Waste Assembly . . . . . . . . . . . . . . . . . . . . . . . . . 5-27

Maintaining the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

Replacing the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29Preparing the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

Removing the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30

Installing the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Verifying Sensor Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Filling the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Performing Reference Sensor Maintenance . . . . . . . . . . . . . . 5-34Cleaning and Inspecting the Reference Sensor . . . . . . . . . . . . . . . 5-34

Filling the Reference Sensor Cassette . . . . . . . . . . . . . . . . . . . . . . 5-36

Maintaining the Internal Reference Electrode. . . . . . . . . . . . . . . . . 5-39

Performing Measurement Sensor Maintenance. . . . . . . . . . . . 5-40

Replacing System Components . . . . . . . . . . . . . . . . . . . 5-42

Replacing the Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42 Replacing the Sample Port . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42 Replacing the CO-ox Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43Replacing the CO-ox Roller Cage . . . . . . . . . . . . . . . . . . . . . . 5-45

Removing the Roller Cage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45 Cleaning the Roller Cage Shaft . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46

Installing the New Roller Cage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46

Replacing the System Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . 5-47

Relocating the System . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49

Shipping or Storing the System . . . . . . . . . . . . . . . . . . . 5-50

Cleaning the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50 Removing the Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50 Cleaning and Drying the Tubing . . . . . . . . . . . . . . . . . . . . . . . . 5-51

Flushing the Tubing for the RCx Reagent . . . . . . . . . . . . . . . . . . . 5-51

Flushing the Upper Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52

Flushing the Lower Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53

Flushing the Tubing for the Samples . . . . . . . . . . . . . . . . . . . . . . . 5-54

Flushing the Tubing for the Measurement Module . . . . . . . . . . . . . 5-55

Flushing the Tubing for the Measurement Module Waste . . . . . . . 5-56

Flushing the Tubing for the AutomaticQC Module . . . . . . . . . . . . . 5-57

Flushing the Reagent Manifold Tubing . . . . . . . . . . . . . . . . . . . . . 5-58


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Flushing the CO-ox Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . .5-59

Removing and Storing the Sensors . . . . . . . . . . . . . . . . . . . . . 5-60 Removing Peripherals and Disinfecting the Exterior Surfaces . 5-60 Shutting Down and Packing the System. . . . . . . . . . . . . . . . . . 5-60

Scheduling Maintenance Activities . . . . . . . . . . . . . . . . 5-61Performing Scheduled Maintenance Tasks . . . . . . . . . . . . . . . 5-61

Maintenance Task Grace Period . . . . . . . . . . . . . . . . . . . . . . . . . . .5-62

Marking Maintenance Tasks Complete . . . . . . . . . . . . . . . . . . . . . .5-62

Undoing the Completed Marker. . . . . . . . . . . . . . . . . . . . . . . . . . . .5-62

Viewing Maintenance Task Details . . . . . . . . . . . . . . . . . . . . . . 5-63Change System Time for Daylight Saving Time. . . . . . . . . . . . 5-63

6 Troubleshooting

Troubleshooting Failed or Missed QC Analysis . . . . . . . 6-1

Troubleshooting the Yellow Parameter Error . . . . . . . . . . . . . . . 6-1Troubleshooting the Purple Parameter Error . . . . . . . . . . . . . . . 6-3Troubleshooting the Ampule QC. . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Troubleshooting Failed Calibrations . . . . . . . . . . . . . . . . 6-4

Troubleshooting Checklist for Failed Calibration . . . . . . . . . . . . 6-4Using the Calibration Report to Identify Problems . . . . . . . . . . . 6-5

Troubleshooting Patient Results . . . . . . . . . . . . . . . . . . . 6-6

Troubleshooting Unavailable Buttons. . . . . . . . . . . . . . . 6-7

Troubleshooting Measurement Module Lights . . . . . . . . 6-8

Troubleshooting Barcode Problems . . . . . . . . . . . . . . . . 6-8 Barcode Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 Resetting the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Troubleshooting Internal Printer Problems. . . . . . . . . . 6-11

Troubleshooting Touchscreen Problems . . . . . . . . . . . 6-11

Solving Communication Problems . . . . . . . . . . . . . . . . 6-12

Clearing the Clot from the Reagent Manifold . . . . . . . . . . . . . . 6-13Clearing the Clot from the Preheater . . . . . . . . . . . . . . . . . . . . 6-17 Clearing the Clot from the Reagent Cartridge . . . . . . . . . . . . . 6-22

Removing Clots Using the Clot-Removal Line . . . . . . . . . . . . . 6-24Inspecting the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24Reinstalling the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30 Completing the Inspection Procedure. . . . . . . . . . . . . . . . . . . . 6-30

Removing Obstructions from the CO-ox Sample Path 6-31

Using Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33

Copying Diagnostic Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34


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Using the Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . . . 6-34Performing Tests and Printing Diagnostic Reports. . . . . . . . . . . . . 6-34

Performing the Waste Detector Calibration . . . . . . . . . . . . . . . . . . 6-35

Calibrating the Touchscreen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35

Using the Fluidic Functions Screen . . . . . . . . . . . . . . . . . . . . . 6-36 Performing the Reagent Flow Tests . . . . . . . . . . . . . . . . . . . . . . . . 6-36 Priming the AQC Cartridge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37

Performing the Leak Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37

Using the Pumps and Valves Screen . . . . . . . . . . . . . . . . . . . . 6-38 Performing the Sample Pump and Wash Pump Tests . . . . . . . . . . 6-39

Performing the R Cartridge Valve Test. . . . . . . . . . . . . . . . . . . . . . 6-40

Performing the AQC Valve Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41

Performing the Measurement Module Pinch Valve Test . . . . . . . . 6-41

Performing the CO-ox Pump Test . . . . . . . . . . . . . . . . . . . . . . . . . 6-42

Using the Cartridges Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42

Ejecting the Wash or Reagent Cartridge . . . . . . . . . . . . . . . . . . . . 6-43Ejecting the AutomaticQC Cartridge. . . . . . . . . . . . . . . . . . . . . . . . 6-43

Using the Sensors Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44Using the CO-ox Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45

Performing the Lamp Calibration Test . . . . . . . . . . . . . . . . . . . . . . 6-45

Performing the Wavelength Cal Test . . . . . . . . . . . . . . . . . . . . . . . 6-46

Performing the CO-ox Sample Chamber Test . . . . . . . . . . . . . . . . 6-46

Performing the Lamp On/Off Test. . . . . . . . . . . . . . . . . . . . . . . . . . 6-47

D Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47

D2 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48 D2 Excessive Drift: pO2 pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48

D2 Excessive Drift: Na+ K + Ca++ Cl¯ . . . . . . . . . . . . . . . . . . . . . . . 6-49

D2 Excessive Drift: Glu Lac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50

D2 Excessive Drift: tHb. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50

D3 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51D3 Slope Error: pO2 pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51

D3 Slope Error: pH Na+ K + Ca++ Cl¯ Ref . . . . . . . . . . . . . . . . . . . 6-51

D3 Slope Error: Glu Lac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-52

D3 Slope Error: tHb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-52

D4 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53D4 Offset Error: pO2 pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53

D4 Offset Error: pH Na+ K + Ca++ Cl¯ . . . . . . . . . . . . . . . . . . . . . . 6-53

D4 Offset Error: Glu Lac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54

D5 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54D5 No Endpoint: Ca++ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54

D5 No Endpoint: Glu Lac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-55

D6 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-56 D6 Excessive Noise: pO2 pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . 6-56

D6 Excessive Noise: pH Na+ K + Ca++ Cl¯. . . . . . . . . . . . . . . . . . . 6-57


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D6 Excessive Noise: Glu Lac . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-57

D8–D22 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-58 D8 pO2 R Cartridge Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-58

D14 No Sample Detected at FD2 . . . . . . . . . . . . . . . . . . . . . . . . . .6-58

D19 Fluid Detector Error: 1, 2, 3 . . . . . . . . . . . . . . . . . . . . . . . . . . .6-58 D20 Pressure Signal Out of Range . . . . . . . . . . . . . . . . . . . . . . . . .6-59

D21 Processing Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-59

D22 Barometric Pressure Error . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-59

D23 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-60 D23 Reagent Flow Error: 2, 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-60

D23 Reagent Flow Error: 3, 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-60



D23 Reagent Flow Error: 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-62

D23 Reagent Flow Error: 7, 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-62

D23 Reagent Flow Error: 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-63D24 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-63

D24 AQC Material Error: 1, 2, 3. . . . . . . . . . . . . . . . . . . . . . . . . . . .6-63

D32 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-63D32 AQC Cartridge Valve Error: 1. . . . . . . . . . . . . . . . . . . . . . . . . .6-63

D32 AQC Cartridge Valve Error: 2. . . . . . . . . . . . . . . . . . . . . . . . . .6-64

D33 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-64D33 R Cartridge Valve Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-64

D34 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-64D34 Waste Detector Cal Error: 1 . . . . . . . . . . . . . . . . . . . . . . . . . . .6-64

D34 Waste Detector Cal Error: 2, 3 . . . . . . . . . . . . . . . . . . . . . . . . .6-64

D35 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-65 D35 Electronics Error: 1-3, 7-12 . . . . . . . . . . . . . . . . . . . . . . . . . . .6-65

D35 Electronics Error: 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-65

D35 Electronics Error: 13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-65

D36 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-65 D36 Cartridge Loading Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-65

D37 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-66 D37 Cartridge Eject Error: 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-66

D37 Cartridge Eject Error: 2, 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-66

D38–D60 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-66 D38 Temp Error: 1-12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-66

D39 Obstruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-67 D40 W Cartridge Prime Error: 1, 2. . . . . . . . . . . . . . . . . . . . . . . . . .6-67

D41 AQC Cartridge Prime Error: 1, 2, 3 . . . . . . . . . . . . . . . . . . . . .6-68

D42 R Cartridge Prime Error: 1, 2 . . . . . . . . . . . . . . . . . . . . . . . . . .6-68

D50 Glucose Sensor Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-69

D51 Lactate Sensor Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-70

D60 Communications Error: 1, 2 . . . . . . . . . . . . . . . . . . . . . . . . . . .6-70


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D70 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70 D70 Optics Error: 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70

D70 Optics Error: 3, 4, 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70

D70 Optics Error: 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71

D70 Optics Error: 11, 12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71D71–D77 Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71

D71 No Sample Detected at FD3 . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71

D73 CO-ox Chamber Position Error . . . . . . . . . . . . . . . . . . . . . . . . 6-72

D75 Lamp Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-72

D76 CO-ox Electronics Error: 1-10 . . . . . . . . . . . . . . . . . . . . . . . . . 6-72

D77 CO-ox Temp Error: 1, 2, 3, 4. . . . . . . . . . . . . . . . . . . . . . . . . . 6-72

D78 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-73D78 No Reagent Detected at CO-ox: 1 . . . . . . . . . . . . . . . . . . . . . 6-73

D78 No Reagent Detected at CO-ox: 2, 3 . . . . . . . . . . . . . . . . . . . 6-73

D78 No Reagent Detected at CO-ox: 4 . . . . . . . . . . . . . . . . . . . . . 6-74

Viewing System Messages . . . . . . . . . . . . . . . . . . . . . . . 6-74

7 File Management

File Names and Formats . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Copying Data Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Copying Patient, QC, or Calibration Data Files . . . . . . . . . . . . . 7-3Copying Diagnostic Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Viewing the Sample Totals . . . . . . . . . . . . . . . . . . . . . . . . 7-4

8 System Configuration

Using the Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Setting up QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Setting Up QC Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Entering Customized QC Range Limits . . . . . . . . . . . . . . . . . . . . . . 8-3

Setting Up Required QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Setting up Required QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . 8-4

Editing Required QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Setting up AutomaticQC Schedule. . . . . . . . . . . . . . . . . . . . . . . 8-5

Setting up AutomaticQC Ranges . . . . . . . . . . . . . . . . . . . . . . . . 8-6 Setting up High G/L QC Options . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Setting up Sample Information . . . . . . . . . . . . . . . . . . . . . 8-7

Defining Patient Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Using Default Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Setting up Patient Demographics or Sample Demographics . . . 8-9Using Patient and Sample Demographics . . . . . . . . . . . . . . . . . . . . 8-9


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Defining Patient Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

Defining Sample Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

Setting up Parameter Selection at Analysis . . . . . . . . . . . . . . . 8-10 Enabling Parameter Selection at Analysis. . . . . . . . . . . . . . . . . . . .8-11

Defining Custom Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11Setting up Sample Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13

Setting up Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13

Using the Parameters On/Off Screen. . . . . . . . . . . . . . . . . . . . 8-13Specific Parameter Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-14

Setting Parameters On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-15

Setting up Parameter Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15 Setting up Demographic Units . . . . . . . . . . . . . . . . . . . . . . . . . 8-15

Default and Alternate Units of Measure. . . . . . . . . . . . . . . . . . . . . .8-16

Required Parameters and Sample Demographics . . . . . . . . . . . . .8-17

Setting up Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19

Setting up System Options . . . . . . . . . . . . . . . . . . . . . . . 8-19

Setting up Country Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19Selecting a Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20

Selecting the Date Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20

Setting up the Date and Time. . . . . . . . . . . . . . . . . . . . . . . . . . 8-20 Setting up the Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21Setting up Other Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21

Setting up Printer and Devices Options . . . . . . . . . . . . 8-22

Selecting Printer Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22 Setting up Barcode Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23

Selecting the Barcode Only Option for Patient ID Entry . . . . . . . . .8-25 Setting up the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . .8-25

Connecting the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . .8-26

Setting up Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26 Defining Send System Data Option . . . . . . . . . . . . . . . . . . . . . . . . .8-26

Connecting to a Rapidlink ® or Rapidcomm® System . . . . . . . . . . .8-27

Connecting to a CompleNet ® Network Connection . . . . . . . . . . . . .8-28

Entering IP Addresses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-29

Using DHCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-30

Selecting sO2 as a Measured or Calculated Value for LIS Transmission (LIS only) . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-30

Connecting to a Laboratory Information System . . . . . . . . . . . 8-30 Setting up Auto Send Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-32

Setting Up Remote Viewing (Rapidcomm Only) . . . . . . . . . . . . . . .8-32

Setting up Secured Options . . . . . . . . . . . . . . . . . . . . . . 8-35

Setting up System Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-35 Setting up Operator Security Levels . . . . . . . . . . . . . . . . . . . . . 8-35

Defining Operator IDs and Passwords . . . . . . . . . . . . . . . . . . . . . .8-37


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Setting Up Analysis Options. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-38 Selecting the Save Demographics Option . . . . . . . . . . . . . . . . . . . 8-38

Selecting Demographics Editing. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-39

Displaying Question Result. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-39

Flagging Microsample Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-40 Defining Analytical Range Limits . . . . . . . . . . . . . . . . . . . . . . . . . . 8-40

Setting up Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-41Setting up the Calibration Interval. . . . . . . . . . . . . . . . . . . . . . . . . . 8-41

Selecting the Calibration Pending Message . . . . . . . . . . . . . . . . . . 8-41

Saving and Restoring System Setup Data . . . . . . . . . . . . . . . . 8-41Installing New System Software . . . . . . . . . . . . . . . . . . . . . . . . 8-42 Setting up Correlation Coefficients . . . . . . . . . . . . . . . . . . . . . . 8-44Setting up Maintenance Functions . . . . . . . . . . . . . . . . . . . . . . 8-44

Setting up a Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . 8-44

Importing and Exporting Maintenance Activities. . . . . . . . . . . . . . . 8-46

Appendix A: Safety Instructions

Protecting Yourself from Biohazards . . . . . . . . . . . . . . . .A-1

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Protecting Yourself from Barcode Scanner Lasers . . . .A-3

Protecting Yourself from Electrical Hazards . . . . . . . . . .A-3

Appendix B: Service, Ordering, and Warranty

Authorized Representative . . . . . . . . . . . . . . . . . . . . . . . .B-1Limited Instrument Warranty andService Delivery Policy . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1

Warranty Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 Additional Service Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 Service During Normal Hours. . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 Extent of a Service Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 Service Outside Normal Hours . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Replacement of Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3Design Changes and Retrofitting of Instruments . . . . . . . . . . . . B-3Key Operator Designation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3

OSHA Requirements (US only) . . . . . . . . . . . . . . . . . . . . . . . . .B-3Warranty and Service Exclusions. . . . . . . . . . . . . . . . . . . . . . . .B-4Copyright Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

GNU General Public License v.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

Baptize V1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6

BDM Download. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

Zip and Unzip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8


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Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9

Authorized Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-9 Addresses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-9

Appendix C: System Fluids

Recommended Fill Volumes . . . . . . . . . . . . . . . . . . . . . . C-1

Rapidlab 1200 Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Appendix D: Supplies

Appendix E: System Specifications

Viewing Parameter Measurements. . . . . . . . . . . . . . . . . . E-1

Understanding System Limitations . . . . . . . . . . . . . . . . . E-5

Interference Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

Interference Testing for Rapidlab 1200 Sensors. . . . . . . . . . . . .E-6 Interference Testing for Rapidlab 1200 CO-oximetry . . . . . . . . .E-9Interference Testing Results for tHb, FO2 Hb, FCOHb, FMetHb, and FHHb. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-10 Irenat (Sodium Perchlorate) Interference whenMeasuring Ionized Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . .E-10 Ethylene Glycol Interference when Measuring Lactate and Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-11

Performance Characteristics . . . . . . . . . . . . . . . . . . . . . E-11Rapidlab 1240 System Performance Characteristics . . . . . . . . E-11

Precision on Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-11

Recovery and Precision of Blood Gases in Human Whole Blood . E-12

Method Comparison with Human Whole Blood Samples . . . . . . . E-17

Rapidlab 1245 System Performance Characteristics . . . . . . . .E-18 Precision on Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-18

Recovery and Precision of Blood Gases in Human Whole Blood . E-20

Recovery and Precision of Hemoglobin Fractions inHuman Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-25


Rapidlab 1260 System Performance Characteristics . . . . . . . .E-30 Precision on Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-30

Recovery and Precision in Human Whole Blood . . . . . . . . . . . . . . E-33


Rapidlab 1265 System Performance Characteristics . . . . . . . .E-49Precision on Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-49


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Recovery and Precision of Blood Gases, Electrolytes, and Metabolites in Human Whole Blood. . . . . . . . . . . . . . . . . . . . . E-52

Recovery and Precision of Hemoglobin Fractions in Human Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-66

Method Comparison with Human Whole Blood Samples. . . . . . . . E-68

Reference Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-72

Calibrator Traceability . . . . . . . . . . . . . . . . . . . . . . . . . . . E-73

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-73

Appendix F: Symbols

Appendix G: Glossary

Appendix H: Rapidlab 1200 System Maintenance Checklist

Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .H-1

Twice Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . .H-1

Weekly Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .H-1

Every 60 Days Maintenance. . . . . . . . . . . . . . . . . . . . . . . .H-2

Quarterly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . H-2

Yearly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .H-2

As Required Maintenance . . . . . . . . . . . . . . . . . . . . . . . . .H-2

Index


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1 System Overview and Intended Use

This section is an introduction to the Rapidlab 1200 system.

Intended Use

The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems candetermine the following parameters:

Features

The Rapidlab 1200 systems have the following features:

• Compact design

• Self-contained reagent and wash cartridges that you can replace easily

• Automatic calibrations of the sensors• Automatic sample aspiration that eliminates variability in sampling technique

• Automatic sampling for QC at customized intervals using the optional

AutomaticQC® cartridge

• High resolution touchscreen that tilts for viewing information and makingselections quickly and easily

• Built-in removable storage media to copy patient, QC, and calibration data forstorage, or for export to spreadsheet or database programs

• Communication ports for connecting to external data management systems,

such as the Rapidlink ® or Rapidcomm® Data Management systems, or an LIS(laboratory information system)

• Self-contained CO-oximetry sample chamber (Rapidlab 1245 and 1265systems) that is easy to replace

• Optional external printer availability

System Parameters

1240 pH, pCO2, pO2

1245 pH, pCO2, pO2, tHb, F O2Hb, F COHb, F MetHb, F HHb

1260 pH, pCO2, pO2, Na+, K +, Ca++, Cl-, glucose, lactate

1265 pH, pCO2, pO2, Na+, K +, Ca++, Cl-, glucose, lactate, tHb, F O2Hb,

F COHb, F MetHb, F HHb


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Hardware Overview

The Rapidlab 1200 system consists of 6 modules.

Figure 1-1 Rapidlab 1200 System

1 User interface module

2 AutomaticQC module (optional)

3 Waste module

4 Reagent module

5 Wash module

6 Measurement and CO-ox modules


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User Interface Module

You use the user interface to request sample analysis, to view and report results,and to edit demographics. The user interface consists of the touchscreen, the printer, the CD drive, and the optional barcode scanner.

The adjustable 10.4-inch monitor is easy to clean. You select items on the screento make selections and enter data.

Figure 1-2 Rapidlab 1200 System–User Interface Module

The thermal roll printer prints reports for samples, calibrations, and diagnostics.

You can also install an external printer. Refer to Setting up Printer and DevicesOptions‚ page 8-22.

1 Printer

2 Touchscreen


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AutomaticQC Module

The optional AutomaticQC module allows the system to automatically analyze QCmaterials. The system performs analysis of the AutomaticQC levels at pre-programmedintervals. For information about programming the intervals, refer to Setting up AutomaticQC Schedule‚ page 8-5.

Figure 1-3 Rapidlab 1200 System with AutomaticQC Module

The AutomaticQC module consists of the following components:

• AutomaticQC cartridge• AutomaticQC interface

AutomaticQC Cartridge

The AutomaticQC cartridge has bags containing 3 levels of quality control material usedfor verification of performance at several points in the clinical range of the Rapidlab 1200.

1 AutomaticQC cartridge

Level Volume Contents

1 75 mL Buffered bicarbonate solution with Na+, K +, Ca++, Cl-, carbondioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and

preservative.


preservative.


preservative.


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The bracket on the AutomaticQC cartridge connects to the support bracket on theside of the system. When the cartridge lever closes, it punctures the bags of QCmaterial. The connection to the reagent cartridge allows QC material to flow fromthe AutomaticQC cartridge to the reagent cartridge.

Refer to Figure 1-5 for the system interface connections.

Figure 1-4 AutomaticQC Cartridge

1 Connectors to the latch assembly

2 Connector to the reagent cartridge

3 Cartridge lever

4 Bracket

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The latch assembly has 4 connections that secure the cartridge to the system. Theconnector connects the AutomaticQC manifold and AutomaticQC cartridge. The support bracket connects to the bracket on the cartridge.

Figure 1-5 AutomaticQC Cartridge System Interface

The AutomaticQC manifold creates the fluid path for AutomaticQC materials to flow tothe sample entry components in the reagent cartridge.

Figure 1-6 AutomaticQC Manifold

1 Latch assembly

2 Support bracket

3 Connector

1 AutomaticQC manifold


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Waste Module

After sample analysis is complete, the waste module collects reagents, samples,and waste. The waste module consists of the following components:

• waste bottle• waste bottle housing

• waste bottle latch

• waste detector

Figure 1-7 Waste Module

1 Waste bottle housing

2 Waste bottle latch

3 Waste bottle


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Waste moves from the measurement module through the pressure detector bubbler, andinto the reagent manifold. Waste moves through the reagent manifold and into the waste bottle.

Figure 1-8 Waste Path

The waste bottle housing protects the waste bottle. The waste detector detects the presenceof the waste bottle and also detects when the bottle is approaching its capacity. The systemalerts you when the waste bottle is between 70 and 100% full. To reduce exposure to biohazards when you remove the waste bottle, the system prevents fluidic operations fromstarting.

1 Path from the measurement module to the reagent manifold

2 Path from the reagent manifold to the waste bottle


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Reagent Module

The reagent module holds the reagents and creates the fluid path for samples,calibrators, and wash fluid.

The reagent module consists of the following components:• reagent cartridge

• cartridge interface frame

• reagent manifold

• reagent door

Reagent Cartridge

The reagent cartridge contains the following 2 calibrators, each in foil bags:

You use these calibrators, as well as the RCx and wash in the wash cartridge, tocalibrate the system. The electrolytes, pH, glucose, lactate, and gases in thereagents are NIST traceable.

The following table lists the targeted calibration points for each analyte in thereagents:

Calibrator Volume Ingredients

Slope 160 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkalihalides), organic buffers, catalyst, and surfactant

200 460 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkalihalides), organic buffers, glucose, lactate, surfactant, and

preservative

Analyte Cal Point Slope Point

pH 6.8 7.4

pCO2 35 mmHg 70 mmHg

pO2 154 mmHg 0 mmHg*

* fixed point via electronic zero

Na+ 116 mmol/L 159 mmol/L

K + 4.0 mmol/L 8.0 mmol/L

Ca++ 1.25 mmol/L 0.62 mmol/L

Cl- 98 mmol/L 69 mmol/L

Glu 180 mg/dL 0 mg/dLLac 2 mmol/L 0 mmol/L

tHb 0 g/dL 15 g/dL


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You introduce samples into the system at the sample port, part of the reagent cartridge.During sample aspiration, the sample port can hold syringes, capillary tubes, or aspirationadapters.

Figure 1-9 Reagent Cartridge–Front View

The sample port attaches to the sliding valve. The sliding valve changes positionsdependent on the function:

• Aspirate patient samples and QC samples

• Select and aspirate reagents and AutomaticQC (AQC) material

Figure 1-10 Reagent Cartridge–Back View

The pumps compress the tubing on the cartridge to generate flow. Adjacent rollers on theroller cage pinch a segment of the tubing in 2 places. The peristaltic action of the moving

rollers pulls the fluid through the tubing.

The cartridge interface frame attaches the reagent and wash cartridges to the system.When you load the reagent cartridge into the system and close the door, the frame movesforward and the pierce pins puncture the bags of calibrators in the cartridge to create afluid path.

1 Sample port

1 Sliding valve

2 Sample and wash pump tubing


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The cartridge interface frame also engages the fluid connectors on the cartridgewith the connectors on the reagent manifold to create the fluid path for calibrators,samples, and waste. The pierce probes engage the pierce pins on the interface plate and the fittings on the bags of calibrators.

Figure 1-11 Reagent Cartridge–Back View

The fluid connectors on the reagent manifold engage with the fluid connectors onthe reagent and wash cartridges to create the fluid path for reagents, samples, andwaste.

Figure 1-12 Reagent Manifold for the Rapidlab 1245 and 1265Systems–front view

1 Pierce probes

2 Fluid connector for AutomaticQC materials3 Fluid connectors to the reagent manifold

1 Measurement module waste tubing

2 Sample tubing3 CO-ox waste tubing

4 RCx reagent from wash cartridge tubing

5 Wash fluid from wash cartridge tubing


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The reagent manifold contains the tubing for samples, waste, AQC material, wash, andcalibrators.

Figure 1-13 Reagent Manifold for the Rapidlab 1245 and 1265 Systems–backview

1 Measurement module waste tubing2 Sample tubing

3 CO-ox waste tubing

4 RCx reagent from wash cartridge tubing

5 Wash fluid from wash cartridge tubing


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Wash Module

The wash module has the following components:

• wash cartridge

• wash door

Wash Cartridge

You load the wash cartridge in the wash door.

Figure 1-14 Rapidlab 1200 System–Wash Module

The wash cartridge contains RCx (a calibrator) and wash reagent (a calibrator andwash fluid) as described in the following table.

1 Wash cartridge

2 Wash door

Reagent Volume Ingredients

RCx 60 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali halides),organic buffers, surfactant, dye, and preservative

Wash 550 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali halides),surfactant, and preservative


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When you load the wash cartridge into the system, the cartridge interface frame movesforward and the pierce pins puncture the bags of calibrator and wash fluid. The cartridgeinterface engages the fluid connectors on the cartridge with the connector on the reagentmanifold.

Figure 1-15 Wash Cartridge–back view

The fluid connectors on the reagent manifold engage with the wash cartridge to create thefluid path for RCx and wash fluid from the wash cartridge to the sample path.

Figure 1-16 Reagent Manifold for Rapidlab 1240 and 1260–front view

1 Fluid connectors

1 RCx reagent connector

2 Wash fluid connectors


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Measurement Module

The system analyzes the sample in the measurement module.

Figure 1-17 Rapidlab 1200 Measurement Module Location

The sample moves through and is analyzed in the sensors, which form the sample path.

Figure 1-18 Measurement Module–Sample Path

1 Measurement module

1 Measurement module sample path


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The sample enters the measurement module at the sample connector and moves throughthe preheater, fluid detector 1, and into the sensors for measurement.

Figure 1-19 Measurement Module

The preheater warms the sample to 37°C and the measurement block ensures a constanttemperature of 37°C. The sample connector provides the fluidic path for the sample fromthe sample entry components in the reagent cartridge to the measurement module.

The sensors detect analytes present in the sample and form the sample path. The system

moves the sample through the sensors and the fluid detector 2, into the pinch valve tubing,and through the pressure detector bubbler.

1 Preheater

2 Fluid detector 1

3 Sample connector

4 Sensors


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The contact assembly provides electrical contact between the sensors and thesystem. The pressure detector bubbler detects clots in the measurement module.

Figure 1-20 Measurement Module–Contact Assembly

The measurement module holds up to 11 sensors.

Figure 1-21 Measurement Module–Sensors

1 Fluid detector 2

2 Pinch valve tubing

3 Pressure detector bubbler

1 pO2 Oxygen 7 K+ Potassium

2 pCO2 Carbon dioxide 8 Ca++ Calcium

3 Gnd Sample ground/temperature 9 Cl- Chloride

4 Glu Glucose 10 Na+ Sodium

5 Lac Lactate 11 Ref Reference

6 pH pH


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Sensors provide direct measurement of a specific substance of interest in a sample. Formore information about sensors, refer to Rapidlab 1200 Systems Technology‚ page 1-27.

The electrolyte sensors, Na+, K +, Ca++, Cl-, pH sensor, and pCO2 sensor work with a

reference sensor and use potentiometry. For more information about potentiometry, referto Potentiometry‚ page 1-27.

The biosensors (glucose, lactate) and the pO2 sensor use amperometry. For more

information about amperometry, refer to Amperometry‚ page 1-33.

CO-ox Module

This section applies to the Rapidlab 1245 and 1265 systems.

The Rapidlab 1200 system CO-oximeter measures the concentration of total hemoglobinand hemoglobin fractions. The CO-ox module contains the following components:

• sample chamber

• sample chamber interface

• polychromator

• pump

Figure 1-22 CO-ox Module

The system measures as the sample flows through the sample chamber. The optics headdirects light through the sample in the sample chamber. The system collects the light at theother side of the optics head and then the polychromator measures it.

1 CO-ox pump

2 CO-ox sample chamber


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The polychromator measures the intensities of light passed through the sample ata number of different wavelengths and converts the electrical signal to a digitalvalue for further processing.

The sample chamber has a sliding cell design that opens and closes to allow for

measurement.

The CO-ox sample chamber is stable for up to 60 days after installation on thesystem. CO-ox sample chamber use life is independent of the number of samplesanalyzed on the system. The system prompts you when you need to replace thesample chamber.

Software Overview

Rapidlab® User Interface

Screens consist of the banner area and a display area.• The banner is at the top of all screens and remains visible when you move

from screen to screen.

The banner contains information about system status and has buttons foraccessing the main system screens.

• The display area contains options and information for the task you are performing.

Figure 1-23 Screen Banner

1 System status area 4 Status screen

2 Analysis screen 5 Help button

3 Recall screen 6 Current time and date


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Viewing the Banner Information

The screen banner area displays the following information:• the current system status (Ready, Not Ready, Calibrating, Analyzing)• the time and type of the next calibration

• status messages (Cal Pending, Required QC Due, AQC Pending, maintenance due oroverdue)

• temperature of patient sample in banner at Results screens, if temperaturedemographic is selected in Setup

• remote viewing status for systems connected to an LIS (refer to Setting Up RemoteViewing (Rapidcomm Only)‚ page 8-32)

Figure 1-24 Banner–Status Information

Viewing Status Messages

The banner displays status messages as reminders for pending tasks. The system alwaysdisplays a message for a pending Required QC regardless of other pending tasks.

The system displays a message when maintenance tasks are due and how many are due.When you perform a maintenance task, the number of tasks on the banner decrements butthe message remains as long as tasks are pending.

Status Symbols

When a cartridge, the CO-ox sample chamber, or the waste bottle approaches itsexpiration date or number of tests available, the system displays the appropriate symbol inthe banner:

1 System status area

2 Cartridge status

Supply Symbol % Volume Number of hours

Wash cartridge 10% Less than 24

Reagent cartridge 10% Less than 24

AutomaticQC cartridge 10 or fewer tests forany level of QCmaterial

Less than 24


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The system tracks the number of hours from the install-by-date or expiration date,which ever date is shorter.

The Analysis symbol accesses the Analysis screen where you analyze samples.The Recall button accesses stored results. The Status button displays cartridgestatus and access to maintenance and diagnostics functions. The Help button provides information about troubleshooting and maintaining the Rapidlab 1200system.

Viewing the Display AreaSome functions are common to all the main screens.

Rapidlab Main System Screens

You access the main system screens by selecting the appropriate button on the banner.

• Analysis screen

• Recall screen

• Status screen

Analysis Screen

The Analysis screen is the main screen for the Rapidlab 1200 systems.

Waste bottle 70% Not limited by time

CO-ox sample chamber Not limited byvolume Less than 72

Button Function

Continue button.Displays the next screen for the task you are performing. The systemautomatically saves selections and entries that you make.

Print button.Prints a report. If the system is connected to a Rapidlink orRapidcomm system, an LIS, or an external printer, the Rapidlab 1200system also sends the report to these computer systems or the printer.

Return button.Displays the previous screen. The system does not save yourselections and entries when you select the Return button.

Video button.Displays a video demonstration of the steps for a procedure.

Supply Symbol % Volume Number of hours


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The group of buttons on the left side of the display area define the type of sample to beanalyzed, patient or QC.

The group of buttons in the center of the display area define the parameters to bemeasured. Available parameters are determined by the sample device, sample mode

selected, and system configuration.

Analysis Screen Sample Options

Before analyzing a sample, you need to select a sample type, sample mode, and parameters. The Rapidlab 1200 systems provide 4 patient sample type options and 4analysis mode options. The parameters available depend on the type of system and Setupoptions you selected.

When analysis is requested, you must also enter patient information. Refer to Entering Patient Sample Data‚ page 2-22.

The top 4 buttons on the left of the screen represent the patient sample types: arterial

syringe, capillary, venous, and mixed venous.

Analysis Screen Parameter Status

The system displays available parameters in the center of the screen. Each parameter can be in a different state, indicated by its appearance, depending on operator selections,definitions in Setup, and current parameter condition.

Parameter Description

Parameter is available but does not display as a button andcannot be selected. Refer to Enabling Parameter Selection at Analysis‚ page 8-11.

Parameter is not selected and results will not be reported for this parameter. Refer to Enabling Parameter Selection at Analysis‚ page 8-11.

Parameter is selected for analysis. Refer to Enabling ParameterSelection at Analysis‚ page 8-11.

Parameter is not available for analysis because the sensor hasfailed calibration. Refer to Troubleshooting Unavailable Buttons‚

page 6-7.

Parameter has failed successive calibrations and is unlikely to become available with further calibrations until corrective actionis taken. Refer to Troubleshooting Unavailable Buttons‚

page 6-7.

Parameter is not available for analysis because the parameterfailed Required QC or AutomaticQC analysis (the button isyellow). Refer to Troubleshooting the Yellow Parameter Error ‚

page 6-1.


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Custom Panels

If you define custom panels for your system, the system displays the custom panels in the lower-left corner of the Analysis screen. Each of the panel buttonsdisplays the parameters that are in that panel. The number buttons, 1 and 2,represent the 2 sets of panels currently available on the system.

The system displays the buttons only when panels are defined. Refer to DefiningCustom Panels‚ page 8-11.

Figure 1-25 Custom Panel Buttons

Sampling Modes on the Analysis Screen

To simplify patient analysis tasks, the Rapidlab 1200 systems have 4 modes ofoperation:

Parameter is not available for analysis because Required QC wasnot performed when scheduled (the button is purple). Refer toTroubleshooting the Yellow Parameter Error ‚ page 6-1.

1 Custom panel buttons

2 Panel set buttons

Mode Description

Microsample Use the Microsample mode when you have insufficient samplefor patient analysis in the default sampling mode.

pH Use the pH mode when you analyze samples for a pH result only.

tHb Use the tHb mode when you analyze samples for tHb,hemoglobin fractions, and oxygenation parameters only (forRapidlab 1245 and 1265 systems).

pH, Glu, Lac Use the pH, Glu, Lac mode to test for pH, Glucose, and Lactateonly.

Parameter Description


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Recall Screen

Select the Recall button to access stored results. For information about the Recall buttonmenu options, refer to the following topics:

Status Screen

The system automatically displays the Status screen if an event occurs that needs yourattention before routine operation can continue. For example, the system displays theStatus screen with a Not Ready message when an error condition prevents sample analysisor when you need to replace a cartridge because it is empty or expired.

You can also manually display the Status screen by selecting the Status button on the banner.

The display area of the Status screen displays the current status of each cartridge:• the cartridge symbol• percent volume• time remaining until the cartridges must be replaced

• buttons to access Status area functions

Buttons on the Status screen display area access several system functions:

Button... Refer to...Patient Recalling Patient Sample Results‚ page 2-30

QC Recalling QC Results‚ page 4-7, including QC Statisticsand Levey-Jennings Graphs

Calibrations Recalling Calibration Results‚ page 3-4

Events Log Viewing System Messages‚ page 6-74

Copy Stored Results Copying Data Files‚ page 7-2

Sample Totals Viewing the Sample Totals‚ page 7-4

Button... Refer to...

Replace Replacing Supplies‚ page 2-2

Maintenance Maintenance‚ page 5-1

Diagnostics Using Diagnostics‚ page 6-33

Calibrate Calibration‚ page 3-1

Setup System Configuration‚ page 8-1

System Info Accessing System Information‚ page 2-5Shutdown Shutting Down the System‚ page 2-6


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Rapidlab 1200 Systems Sample Path

This section describes the path of a sample through the system from sample entry,to measurement, and then to the waste bottle.

System Sample Path

The system aspirates the sample at the sample port. The sample moves throughthe sample tubing and reagent manifold into the sample connector and into themeasurement module.

Figure 1-26 Rapidlab 1200 Sample Path–Sample Port to MeasurementModule

1 Sample connector

2 Sample tubing and reagent manifold.

3 Sample port


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CO-ox Sample Path

The system splits the sample in the preheater and moves part of the sample through theCO-ox module. The CO-ox sample moves through the CO-ox sample tubing to the samplechamber for analysis and exits as waste through the waste tubing. The system analyzes thesample in the CO-ox sample chamber. After analysis, the system moves the waste to thereagent manifold, passing through the reagent cartridge, and on to the waste bottle.

Figure 1-27 Rapidlab 1200 Sample Path–To CO-ox Module to Waste

1 Preheater

2 Sample chamber

3 Tubing to the reagent manifold


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Rapidlab 1200 Systems Technology

The measurement technology used for the Rapidlab 1200 systems is based onelectrochemical, biochemical, and optical physics. Electrochemistry is themeasurement of current or voltage in an electrochemical cell. The cell has 2 ormore electrodes that interact with a chemical in solution and are connected to anelectrical system.

Electrodes used for measurement in the Rapidlab 1200 systems are called sensors.Sensors are responsible for direct measurement of a specific substance of interestin a sample. The Rapidlab 1200 systems sensors have the followingcharacteristics:

The molecular recognition mechanism gives a sensor its identity. Each sensor isdesigned to selectively measure the activity of a specific substance. Althoughmany elements in a sample may interact with a sensor, the sensor is highlyselective for 1 substance over others. The common recognition mechanism usedin many Rapidlab 1200 sensors is a membrane designed to be selective for aspecific substance.

The transducer mechanism converts the potential generated by the molecularrecognition mechanism to an electrical signal. In the Rapidlab 1200 systems, thisis accomplished through potentiometry or amperometry. For information aboutPotentiometry, continue reading at the next section. For information aboutAmperometry, refer to Amperometry‚ page 1-33.

Potentiometry

Potentiometry is the measurement of the voltage or potential generated between2 electrodes in an electrochemical cell when no external current is applied and thecell is in a state of equilibrium. The electrochemical cell consists of 2 electrodes (ameasuring or indicator electrode and a reference electrode), an electrolyte solution

(sample solution), and a measuring device such as a voltmeter. Theelectrochemical cell is capable of measuring the concentration or activity of asubstance in a solution.

Molecular or ion-specificrecognition mechanism

a membrane that is selective for a specific ion

Transducer mechanism converts the potential generated by the recognitionmechanism to an electrical signal using

potentiometry or amperometry

Signal processor system conditions the electronic signal from the sensor; theelectronic signals are then converted into aconcentration expressed in units of measure


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Each electrode, which acts as a half-cell with a half-cell potential, contains an innerreference element immersed in an internal electrolyte solution. The measuring electrode isdesigned to respond to changes in the concentration of the specific analyte being measuredin the sample solution. The electrode develops a half-cell potential that is directly relatedto the concentration or activity of the specific analyte. The reference electrode provides asteady, unchanging potential to the cell. Both electrodes are connected to the measuringdevice. With the current in the cell at zero, the potential developed by the electrochemicalcell is determined by calculating the difference in potential between the measuringelectrode and the reference electrode.

Ecell = Emeas - (Eref + Elj)

where

Ecell = electrochemical cell potential

Emeas = measuring electrode half-cell potential

Eref = reference electrode half-cell potential

El j = liquid junction potential

The liquid junction potential (Elj), a small but significant voltage, develops at the liquid

junction between the reference electrode, which contains a solution of saturated potassiumchloride, and the sample solution. This potential occurs because of the different rates atwhich chemical species diffuse across the boundary between 2 liquids. This difference inrates results in a charge separation that gives rise to the liquid junction potential. Although

the potential formed is small, it must be considered when measuring cell potential.1

System sensors are designed to measure a specific substance in a sample. For the purpose

of measuring a variety of analytes in solution, sensors must have the ability to measurespecific analytes in solution. This ability is kno

Rapid Lab 1200 Operators Guide

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