Siemens Rapidlab 1200 Operator's Manual

Rapidlab® 1200 Systems

Operator’s Guide

02087462 Rev. V, 2010–01

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

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 B

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 sp equipment may be impaired. See warning and hazard statements.

diagnostic use.

usiness Machines Corporation.

ecified by Siemens, the

protection provided by the

Using This Guide

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

• Routine operators These are medical or laboratory personnel who use the Rapidlab 1200

systems 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 perform

Setup functions, monitor the use of the Rapidlab 1200 systems, and assist with 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,

process samples, monitor status, or manage sample results,

calibrate the system, Section 3:

learn about QC options, analyze QC samples,

perform scheduled maintenance activities, record maintenance activities,

investigate and correct system problems, Section 6: Troubleshooting.

manage data files, Section 7:

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

learn about biohazard precautions, learn about laser precautions,

Section 1:

System Features Hardware Overview, Software Overview, Technology.

Section 2:

Operating the System.

Calibration.

Section 4:

Quality Control.

Section 5:

Maintenance.

Data Management.

Section 8:

System Configuration.

Appendix A:

Safety.

02087462 Rev. V

ii Rapidlab 1200 Operator’s Guide: Using This Guide

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

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

learn about fill volume and stability information about system fluids,

find information about ordering supplies, Appendix D:

learn about system specifications, Appendix E:

learn about system symbols, Appendix F:

learn about system terms, Appendix G:

Conventions

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

Convention Description

BIOHAZARD:

Appendix B:

Warranty and Support Information.

Appendix C:

System Fluids.

Ordering Supplies.

System Specifications.

Symbols.

Glossary.

Biohazard statements alert you to potentially biohazardous conditions.

Laser Warning statements alert you to the risk of

LASER WARNING:

WARNING:

CAUTION:

NOTE: Note statements alert you to important information

Bold Bold type indicates commands on the user

exposure to lasers.

Warning statements alert you to conditions that may cause personal injury.

Caution statements alert you to conditions that may cause product damage or loss of data.

On the system, this symbol indicates that you should refer to the operator’s guide for more information.

that requires your attention.

interface, keys, or the exact text that an operator needs to type.

For example, if the word save is displayed as it refers to the selecting the Save button on the user interface.

Another example is typing a specific entry into a text box. If the word welcome is displayed as

welcome, it means that you should type that word

into the specified field.

Save,

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: Using This Guide iii

Convention Description

Italic Italic type refers to the title of a document or a

section title in this operator’s guide. For example, Operating the System‚ page 2-1 refers to Section 2 of this operator’s guide.

Terminology

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

Term Description

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

monitor.

Enter Use the numeric or alphanumeric sections of the touchscreen to enter the

specified information.

Scan Move the hand-held barcode scanner over the specified barcode to enter

the information.

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iv Rapidlab 1200 Operator’s Guide: Using This Guide

02087462 Rev. V

Using This Guide

1 System Overview and Intended Use

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

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

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

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13

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

Measurement Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

CO-ox Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Rapidlab® 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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vi Rapidlab 1200 Operator’s Guide: Contents

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

Oxygen Tension (pO

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54

Base Excess. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54

Total 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

Calcium Adjustment for pH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59

Anion Gap. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59

Gas 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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59

2/FIO2

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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 . . . . . . . . . . . . . . . . . . . . 2-1

Entering Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Replacing 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. . . . . . . . . . . . . . . . . . . . . . . .2-3

Reinstalling 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 . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Understanding 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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viii Rapidlab 1200 Operator’s Guide: Contents

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 . . . . . . . . . . . . . . . . . . . 2-31

Printing 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 . . . . . . . . . . . . . . . . . . . . . . 3-3

Generating 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 . . . . . . . . . . . . . . . . . . 4-1

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

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

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

Performing 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 . . . . . . . . 4-4

Using the Unscheduled QC Option . . . . . . . . . . . . . . . . . . . . . . 4-4

Performing Unscheduled QC Sample Analysis . . . . . . . . . . . . . . . . 4-4

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

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

Result Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

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

Rapidlab 1200 Operator’s Guide: Contents ix

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

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

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

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

Using the Recall–Levey-Jennings Screens . . . . . . . . . . . . . . . 4-11

Viewing 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 . . . . . . . . . . . . . . . . . . . . . . .5-3

Performing Twice Weekly Maintenance. . . . . . . . . . . . . . 5-3

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

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

Deproteinizing the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Conditioning 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 . . . . . . . . . . . . . . . . . . .5-9

Checking 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. . . . . . . . . . . . . . . . . . . . 5-19

Completing 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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x Rapidlab 1200 Operator’s Guide: Contents

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

Preparing 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 . . . . . . . . . . . . . . 5-34

Cleaning 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

Replacing 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

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: Contents xi

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 . . . . . . . . . . . . . . . . 5-61

Performing 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 . . . . . . . . . . . . . . . . . . . . . . 5-63

Change System Time for Daylight Saving Time. . . . . . . . . . . . 5-63

6 Troubleshooting

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

Troubleshooting the Yellow Parameter Error . . . . . . . . . . . . . . . 6-1

Troubleshooting the Purple Parameter Error . . . . . . . . . . . . . . . 6-3

Troubleshooting the Ampule QC. . . . . . . . . . . . . . . . . . . . . . . . . 6-3

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

Troubleshooting Checklist for Failed Calibration . . . . . . . . . . . .6-4

Using 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 . . . . . . . . . . . . . . 6-13

Clearing the Clot from the Preheater . . . . . . . . . . . . . . . . . . . . 6-17

Clearing the Clot from the Reagent Cartridge . . . . . . . . . . . . . 6-22

Removing Clots Using the Clot-Removal Line . . . . . . . . . . . . . 6-24

Inspecting the Sample Path . . . . . . . . . . . . . . . . . . . . . . . . . . .6-24

Reinstalling 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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xii Rapidlab 1200 Operator’s Guide: Contents

Using the Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . . . 6-34

Performing 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 . . . . . . . . . . . . . . . . . . . . 6-43

Ejecting the AutomaticQC Cartridge. . . . . . . . . . . . . . . . . . . . . . . . 6-43

Using the Sensors Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44

Using 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

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

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

D3 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51

D3 Slope Error: pO D3 Slope Error: pH Na

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

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

D4 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53

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

D4 Offset Error: pH Na

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

D5 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54

D5 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¯ . . . . . . . . . . . . . . . . . . . . . . . 6-49

pCO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51

+ K+

Ca++ Cl¯ Ref . . . . . . . . . . . . . . . . . . . 6-51

+ K+

Ca++ Cl¯ . . . . . . . . . . . . . . . . . . . . . . 6-53

+ K+

Ca++ Cl¯. . . . . . . . . . . . . . . . . . . 6-57

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Rapidlab 1200 Operator’s Guide: Contents xiii

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: 4, 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-61

D23 Reagent Flow Error: 5, 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-61

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

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

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

D24 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-63

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

D32 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-63

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

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

D33 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-64

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

D34 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-64

D34 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71

D71–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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-73

D78 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 . . . . . . . . . . . . . 7-3

Copying 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Setting 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

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

Defining Patient Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Using Default Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

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

Using Patient and Sample Demographics . . . . . . . . . . . . . . . . . . . . 8-9

Rapidlab 1200 Operator’s Guide: Contents xv

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

Setting up Sample Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13

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

Using the Parameters On/Off Screen. . . . . . . . . . . . . . . . . . . . 8-13

Specific 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19

Selecting a Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20

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

Setting up the Date and Time. . . . . . . . . . . . . . . . . . . . . . . . . . 8-20

Setting up the Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21

Setting 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 Connecting to a CompleNet

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

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

Selecting sO2 as a Measured or Calculated Value

for LIS Transmission (LIS only) . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-30

or Rapidcomm® System . . . . . . . . . . .8-27

Network Connection . . . . . . . . . . . . .8-28

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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xvi Rapidlab 1200 Operator’s Guide: Contents

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-41

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

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

Saving and Restoring System Setup Data . . . . . . . . . . . . . . . . 8-41

Installing New System Software . . . . . . . . . . . . . . . . . . . . . . . . 8-42

Setting up Correlation Coefficients. . . . . . . . . . . . . . . . . . . . . . 8-44

Setting 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-1

Limited Instrument Warranty and

Service 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-3

Design Changes and Retrofitting of Instruments . . . . . . . . . . . .B-3

Key Operator Designation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3

OSHA Requirements (US only) . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Warranty and Service Exclusions. . . . . . . . . . . . . . . . . . . . . . . .B-4

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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Rapidlab 1200 Operator’s Guide: Contents xvii

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-9

Interference Testing Results for tHb, FO

FMetHb, and FHHb. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-10

Irenat (Sodium Perchlorate) Interference when

Measuring Ionized Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . .E-10

Ethylene Glycol Interference when Measuring Lactate

and Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-11

Hb, FCOHb,

Performance Characteristics . . . . . . . . . . . . . . . . . . . . . E-11

Rapidlab 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 in

Human Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-25

Method Comparison with Human Whole Blood Samples . . . . . . . E-28

Rapidlab 1260 System Performance Characteristics . . . . . . . .E-30

Precision on Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-30

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

Method Comparison with Human Whole Blood Samples . . . . . . . E-46

Rapidlab 1265 System Performance Characteristics . . . . . . . .E-49

Precision on Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-49

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xviii Rapidlab 1200 Operator’s Guide: Contents

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

02087462 Rev. V

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 can determine the following parameters:

System Parameters

1240 pH, pCO

1245 pH, pCO2, pO2, tHb, FO2Hb, FCOHb, FMetHb, FHHb

, pO

Features

1260

1265

pH, pCO

pH, pCO FCOHb, FMetHb, FHHb

, pO2, Na+, K+, Ca++, Cl-, glucose, lactate

, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb,

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 making selections quickly and easily

• Built-in removable storage media to copy patient, QC, and calibration data for storage, 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 1265 systems) that is easy to replace

• Optional external printer availability

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1-2 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Hardware Overview

The Rapidlab 1200 system consists of 6 modules.

1 User interface module 2 AutomaticQC module (optional) 3 Waste module 4 Reagent module 5 Wash module 6 Measurement and CO-ox modules

Figure 1-1 Rapidlab 1200 System

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Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-3

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 screen to make selections and enter data.

1 Printer 2 Touchscreen

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 Devices Options‚ page 8-22.

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1-4 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

AutomaticQC Module

The optional AutomaticQC module allows the system to automatically analyze QC materials. The system performs analysis of the AutomaticQC levels at pre-programmed intervals. For information about programming the intervals, refer to

AutomaticQC Schedule‚ page 8-5.

Setting up

1 AutomaticQC cartridge

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 used for verification of performance at several points in the clinical range of the Rapidlab

Level Volume Contents

175 mL

2115 mL

3155 mL

Buffered bicarbonate solution with Na dioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and preservative.

, K+, Ca++, Cl-, carbon

1200.

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Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-5

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

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

1 Connectors to the latch assembly 2 Connector to the reagent cartridge 3 Cartridge lever 4 Bracket

Figure 1-4 AutomaticQC Cartridge

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1-6 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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

1 Latch assembly 2 Support bracket 3 Connector

Figure 1-5 AutomaticQC Cartridge System Interface

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

1 AutomaticQC manifold

02087462 Rev. V

Figure 1-6 AutomaticQC Manifold

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-7

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

1 Waste bottle housing 2 Waste bottle latch 3 Waste bottle

Figure 1-7 Waste Module

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1-8 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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

1 Path from the measurement module to the reagent manifold 2 Path from the reagent manifold to the waste bottle

Figure 1-8 Waste Path

The waste bottle housing protects the waste bottle. The waste detector detects the presence of the waste bottle and also detects when the bottle is approaching its capacity. The system alerts 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 from starting.

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Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-9

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:

Calibrator Volume

Slope 160 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali

200 460 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali

Ingredients

halides), organic buffers, catalyst, and surfactant

halides), organic buffers, glucose, lactate, surfactant, and preservative

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

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

Analyte Cal Point Slope Point

pH 6.8 7.4

pCO

Glu 180 mg/dL 0 mg/dL

35 mmHg 70 mmHg

154 mmHg

116 mmol/L 159 mmol/L

4.0 mmol/L 8.0 mmol/L

1.25 mmol/L 0.62 mmol/L

98 mmol/L 69 mmol/L

0 mmHg

Lac 2 mmol/L 0 mmol/L

tHb 0 g/dL 15 g/dL

* fixed point via electronic zero

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1-10 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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 aspiration adapters.

1 Sample port

Figure 1-9 Reagent Cartridge–Front View

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

• Aspirate patient samples and QC samples

• Select and aspirate reagents and AutomaticQC (AQC) material

1 Sliding valve 2 Sample and wash pump tubing

Figure 1-10 Reagent Cartridge–Back View

The pumps compress the tubing on the cartridge to generate flow. Adjacent rollers on the roller 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 moves forward and the pierce pins puncture the bags of calibrators in the cartridge to create a fluid path.

02087462 Rev. V

+ 418 hidden pages

Siemens Rapidlab 1200 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Using This Guide

Organization

Conventions

Terminology

Contents

1 System Overview and Intended Use

Intended Use

Features

Hardware Overview

User Interface Module

AutomaticQC Module

AutomaticQC Cartridge

Waste Module

Reagent Module

Reagent Cartridge