Siemens Rapidlab 1200 Operator's Manual

Rapidlab® 1200 Systems

Operator’s Guide

02087462 Rev. V, 2010–01

© 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

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.

02087462 Rev. V

iv Rapidlab 1200 Operator’s Guide: Using This Guide

02087462 Rev. V

Contents

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

02087462 Rev. V

vi Rapidlab 1200 Operator’s Guide: Contents

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

Oxygen Tension (pO

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38

2

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

pO

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

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: Contents vii

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

02087462 Rev. V

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

02087462 Rev. V

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

02087462 Rev. V

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

02087462 Rev. V

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

2

+ K+

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

+ K+

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

+ K+

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

02087462 Rev. V

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

02087462 Rev. V

xiv Rapidlab 1200 Operator’s Guide: Contents

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

02087462 Rev. V

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

02087462 Rev. V

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

Copyright 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

02087462 Rev. V

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,

2

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

02087462 Rev. V

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

2

2

Features

1260

1265

pH, pCO

pH, pCO
FCOHb, FMetHb, FHHb

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

2

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

2

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

02087462 Rev. V

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

02087462 Rev. V

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.

02087462 Rev. V

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.

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

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

+

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

+

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

+

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

1200.

02087462 Rev. V

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

02087462 Rev. V

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

02087462 Rev. V

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.

02087462 Rev. V

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

2

pO

2

+

Na

+

K

++

Ca

-

Cl

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

02087462 Rev. V

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

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-11

The cartridge interface frame also engages the fluid connectors on the cartridge
with 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.

1 Pierce probes
2 Fluid connector for AutomaticQC materials
3 Fluid connectors to the reagent manifold

Figure 1-11 Reagent Cartridge–Back View

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

1 Measurement module waste tubing
2 Sample tubing
3 CO-ox waste tubing
4 RCx reagent from wash cartridge tubing
5 Wash fluid from wash cartridge tubing

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

02087462 Rev. V

1-12 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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

1 Measurement module waste tubing
2 Sample tubing
3 CO-ox waste tubing
4 RCx reagent from wash cartridge tubing
5 Wash fluid from wash cartridge tubing

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

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-13

Wash Module

The wash module has the following components:

• wash cartridge

• wash door

Wash Cartridge

You load the wash cartridge in the wash door.

1 Wash cartridge
2 Wash door

Figure 1-14 Rapidlab 1200 System–Wash Module

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

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

02087462 Rev. V

1-14 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

When you load the wash cartridge into the system, the cartridge interface frame moves
forward and the pierce pins puncture the bags of calibrator and wash fluid. The cartridge
interface engages the fluid connectors on the cartridge with the connector on the reagent
manifold.

1 Fluid connectors

Figure 1-15 Wash Cartridge–back view

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

1 RCx reagent connector
2 Wash fluid connectors

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

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-15

Measurement Module

The system analyzes the sample in the measurement module.

1 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.

1 Measurement module sample path

Figure 1-18 Measurement Module–Sample Path

02087462 Rev. V

1-16 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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

1 Preheater
2 Fluid detector 1
3 Sample connector
4 Sensors

Figure 1-19 Measurement Module

The preheater warms the sample to 37°C and the measurement block ensures a constant
temperature of 37°C. The sample connector provides the fluidic path for the sample from
the 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.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-17

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

1 Fluid detector 2
2 Pinch valve tubing
3 Pressure detector bubbler

Figure 1-20 Measurement Module–Contact Assembly

The measurement module holds up to 11 sensors.

1 pO
2 pCO

Oxygen 7

2

Carbon dioxide 8

2

3 Gnd Sample ground/temperature 9
4 Glu Glucose 10
5 Lac Lactate 11 Ref Reference

6 pH pH

K
Ca
Cl
Na

+

++

-

+

Potassium
Calcium
Chloride
Sodium

Figure 1-21 Measurement Module–Sensors

02087462 Rev. V

1-18 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Sensors provide direct measurement of a specific substance of interest in a sample. For
more 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, refer

to

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 hemoglobin
and hemoglobin fractions. The CO-ox module contains the following components:

• sample chamber

• sample chamber interface

• polychromator

•pump

02087462 Rev. V

1 CO-ox pump
2 CO-ox sample chamber

Figure 1-22 CO-ox Module

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

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-19

The polychromator measures the intensities of light passed through the sample at
a number of different wavelengths and converts the electrical signal to a digital
value 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 the
system. CO-ox sample chamber use life is independent of the number of samples
analyzed on the system. The system prompts you when you need to replace the
sample 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 for
accessing the main system screens.

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

1 System status area 4 Status screen
2 Analysis screen 5 Help button
3 Recall screen 6 Current time and date

Figure 1-23 Screen Banner

02087462 Rev. V

1-20 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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 or
overdue)

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

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

1 System status area
2 Cartridge status

Figure 1-24 Banner–Status Information

Viewing Status Messages

The banner displays status messages as reminders for pending tasks. The system always
displays 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 but
the message remains as long as tasks are pending.

Status Symbols

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

Supply Symbol % Volume Number of hours

Wash cartridge 10% Less than 24

Reagent cartridge 10% Less than 24

02087462 Rev. V

AutomaticQC cartridge 10 or fewer tests for

any level of QC
material

Less than 24

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-21

Supply Symbol % Volume Number of hours

Waste bottle 70% Not limited by time

CO-ox sample chamber Not limited by

volume

Less than 72

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 cartridge
status and access to maintenance and diagnostics functions. The Help button
provides information about troubleshooting and maintaining the Rapidlab

1200

system.

Viewing the Display Area

Some functions are common to all the main screens.

Button Function

Continue button.
Displays the next screen for the task you are performing. The system

automatically saves selections and entries that you make.

Print button.
Prints a report. If the system is connected to a Rapidlink or

Rapidcomm system, an LIS, or an external printer, the Rapidlab 1200
system also sends the report to these computer systems or the printer.

Return button.
Displays the previous screen. The system does not save your

selections and entries when you select the Return button.

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

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.

02087462 Rev. V

1-22 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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

The group of buttons in the center of the display area define the parameters to be
measured. 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 4
analysis mode options. The parameters available depend on the type of system and Setup
options 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 and
cannot 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 Parameter
Selection at Analysis‚ page 8-11.

Parameter is not available for analysis because the sensor has
failed 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 action
is taken. Refer to Troubleshooting Unavailable Buttons‚
page 6-7.

Parameter is not available for analysis because the parameter
failed Required QC or AutomaticQC analysis (the button is
yellow). Refer to Troubleshooting the Yellow Parameter Error‚
page 6-1.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-23

Parameter Description

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

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 buttons
displays 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 Defining
Custom Panels‚ page 8-11.

1 Custom panel buttons
2 Panel set buttons

Figure 1-25 Custom Panel Buttons

Sampling Modes on the Analysis Screen

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

Mode Description

Microsample Use the Microsample mode when you have insufficient sample

for 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 (for
Rapidlab 1245 and 1265 systems).

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

only.

02087462 Rev. V

1-24 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Recall Screen

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

Button... Refer to...

Patient Recalling Patient Sample Results‚ page 2-30

QC Recalling QC Results‚ page 4-7, including QC Statistics

and 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

Status Screen

The system automatically displays the Status screen if an event occurs that needs your
attention before routine operation can continue. For example, the system displays the
Status screen with a Not Ready message when an error condition prevents sample analysis
or 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...

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 2-5

Shutdown Shutting Down the System‚ page 2-6

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-25

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 through
the sample tubing and reagent manifold into the sample connector and into the
measurement module.

1 Sample connector
2 Sample tubing and reagent manifold.
3 Sample port

Figure 1-26 Rapidlab 1200 Sample Path–Sample Port to Measurement
Module

02087462 Rev. V

1-26 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

CO-ox Sample Path

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

1 Preheater
2 Sample chamber
3 Tubing to the reagent manifold

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

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-27

Rapidlab 1200 Systems Technology

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

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

1200 systems sensors have the following

Molecular or ion-specific
recognition mechanism

Transducer mechanism converts the potential generated by the recognition

Signal processor system conditions the electronic signal from the sensor; the

a membrane that is selective for a specific ion

mechanism to an electrical signal using
potentiometry or amperometry

electronic signals are then converted into a
concentration expressed in units of measure

The molecular recognition mechanism gives a sensor its identity. Each sensor is
designed to selectively measure the activity of a specific substance. Although
many elements in a sample may interact with a sensor, the sensor is highly
selective for 1 substance over others. The common recognition mechanism used
in many Rapidlab

1200 sensors is a membrane designed to be selective for a

specific substance.

The transducer mechanism converts the potential generated by the molecular
recognition mechanism to an electrical signal. In the Rapidlab

1200 systems, this
is accomplished through potentiometry or amperometry. For information about
Potentiometry, continue reading at the next section. For information about
Amperometry, refer to

Amperometry‚ page 1-33.

Potentiometry

Potentiometry is the measurement of the voltage or potential generated between
2

electrodes in an electrochemical cell when no external current is applied and the
cell is in a state of equilibrium. The electrochemical cell consists of 2 electrodes (a
measuring or indicator electrode and a reference electrode), an electrolyte solution
(sample solution), and a measuring device such as a voltmeter. The
electrochemical cell is capable of measuring the concentration or activity of a
substance in a solution.

02087462 Rev. V

1-28 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Each electrode, which acts as a half-cell with a half-cell potential, contains an inner
reference element immersed in an internal electrolyte solution. The measuring electrode is
designed to respond to changes in the concentration of the specific analyte being measured
in the sample solution. The electrode develops a half-cell potential that is directly related
to the concentration or activity of the specific analyte. The reference electrode provides a
steady, unchanging potential to the cell. Both electrodes are connected to the measuring
device. With the current in the cell at zero, the potential developed by the electrochemical
cell is determined by calculating the difference in potential between the measuring
electrode and the reference electrode.

E

cell

= E

meas

- (E

ref

+ Elj)

where

E

= electrochemical cell potential

cell

E

= measuring electrode half-cell potential

meas

E

= reference electrode half-cell potential

ref

Elj = 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 potassium

chloride, and the sample solution. This potential occurs because of the different rates at
which chemical species diffuse across the boundary between 2 liquids. This difference in
rates 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 measure
specific analytes in solution. This ability is known as the recognition mechanism. For
example, an Ion Selective Electrode (ISE) contains a specifically designed membrane that
provides sensor selectivity. Selectivity is the ability of the sensor to interact with a specific
ion in solution. The membrane separates an inner, reference element, which is immersed
in a fixed electrolyte solution, from the sample.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-29

During analysis, a membrane potential develops as a result of the interaction of
the analyte (ion) at the membrane. The membrane potential is related to the
amount of substance being measured in the sample. The half-cell potential in the
sensor consists of the inner reference element potential plus the membrane
potential.

1 Voltmeter
2 Potassium chloride solution
3 Inner element of the reference electrode
4 Liquid junction potential develops
5 Ion-selective membrane
6 ISE inner reference element
7 A fixed electrolyte solution

Figure 1-28 Electrode Elements

The equation for calculating electrochemical cell potential can be expanded to
include the inner reference element and the membrane potential of the ISE.

E

cell

= (E

ref elmt

+ E

memb

) - (E

+ Elj)

ref

where

E

= electrochemical cell potential

cell

E

E

E

= potential of the ISE inner reference element

ref elmt

= potential of the ISE membrane

memb

= reference electrode half-cell potential

ref

E

= liquid junction potential

lj

02087462 Rev. V

1-30 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

In this equation, the reference electrode potential and the potential of ISE inner reference
element are constant; the liquid junction potential can be controlled. Therefore, the
potential remaining is the potential generated at the membrane. The membrane potential
corresponds to the ion activity and is related directly to the concentration of the ion in

solution. The cell potential is expressed quantitatively by the Nernst equation.

E

= K + (2.3 RT/ZF) log a

cell

i

1

where

E

= electrochemical cell potential

cell

K = a constant from various sources such as the liquid junction

R = gas constant

T = absolute temperature

Z = ionic charge

F = Faraday’s constant

ai = activity of the ion in the sample

This equation states that the cell potential is logarithmically related to the activity of the
analyte in the sample.

The potential that the sensor actually measures is the activity of the analyte in solution. In
clinical chemistry, it is typical that the results be expressed in the concentration of total
substance rather that the activity of the substance. For this reason, the measured results
must be expressed in units of concentration.

The activity equals the numerical value of the concentration of the ion (mol/L) times the
activity coefficient. The activity coefficient is a measure of the degree with which the ion
interacts with other ions in solution. The activity coefficient is dimensionless and depends
on the ionic strength of the solution:

I = 1/2 ∑ m * z

2

where

I = ionic strength of the solution

m = concentration of the ion (mol/L)

z = the charge number of the ions in solution

The activity coefficient generally decreases with increasing ionic strength.

2

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-31

Using an established convention, the activity of ions that are measured by sensors
can be expressed in terms of concentration. This convention contains the

assumption that the normal ionic strength of blood plasma water is 160 mmol/kg.
Because ionic strength is the primary variable affecting the activity coefficient of
ionic species in solution, controlling the ionic strength of calibrating solutions to
160 mmol/kg sets the activity coefficients of ionic species in the calibrating
solutions equal to those of blood plasma water at sample ionic strengths close to
normal. Both calibrations and the expression of measured quantities may then be

made in units of concentration instead of activity.

4

Reference Sensor

The reference sensor for the 1200 systems works with certain measuring sensors
in the measurement module to create an electrochemical cell. The reference
sensor provides a fixed potential, which is independent of analyte activity. The
system compares the fixed potential of the reference sensor to the measured
potential from the following sensors:

Sensor System

pH 1240, 1245, 1260, 1265

Na

K

Cl

Ca

+

+

-

++

1260, 1265

1260, 1265

1260, 1265

1260, 1265

3

02087462 Rev. V

1-32 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

The reference sensor contains a silver (Ag) wire, coated with a layer of silver chloride
(AgCl) and an ion permeable polymer, surrounded by a saturated potassium chloride

-

(KCl) solution. By ensuring that the concentration of Cl

remains unchanged in the
solution, the reference sensor maintains a constant electrical potential. A potassium
chloride (KCl) block is in the reference sensor solution chamber to ensure a saturation
solution of KCl at 37°C.

1 Solution chamber
2 Saturated potassium chloride solution
3 Silver/silver chloride electrode
4 Sample path

Figure 1-29 Reference Electrode

A permeable cellulose membrane separates the KCl solution from the sample and provides
the ionic conduction between the KCl solution and the sample. The membrane completes
the conductive path to the sample from the fixed half-cell potential that is required for the
measurement.

The Ag wire conducts the half-cell potential of the reference sensor to the measurement
device where it is compared to the potential of the measuring sensor. The potential
difference measured reflects the concentration of analyte in the sample. Although the
reference sensor provides a constant potential from sample to sample, the potential
difference measured between sensors varies with each sample.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-33

+

−= cHpH

10

log

Amperometry

Amperometry is an electrochemical technique used to determine the amount of a
specific substance in solution by applying a fixed voltage between 2 electrodes in
an electrochemical cell, and then measuring the current generated as a result of a
reaction which produces or consumes electrons (oxidation or reduction,
respectively).

The electrochemical cell contains 2 electrodes: the anode,

which is positively
charged and the cathode, which is negatively charged. The measuring electrode,
which is frequently composed of platinum (Pt) or another noble metal, can be
either the anode or the cathode. Each electrode is attached to an external voltage
source.

As the sample comes in contact with the 2 elec

trodes, a known voltage is applied
between the anode and the cathode. The analyte to be measured is either an
oxidizable or reducible species. If the analyte is an oxidizable species, it will
diffuse to the anode where it is oxidized. If the analyte is a reducible species, it
will diffuse to the cathode, where it is reduced. In either case, the electrochemical
reaction produces a current flow between the anode and cathode that can be
measured by a device, such as a milli/micro ammeter. The current measured is
directly proportional to the concentration of substance (oxidizable or reducible)
present in the sample solution.

pH and Blood Gases

The Rapidlab 1200 systems analyze blood samples for pH, pO2, and pCO2.

Hydrogen Ion Activity or pH

The notation of pH expresses the hydrogen ion activity in a solution as the
negative logarithm of the hydrogen ion concentration. The hydrogen ion is
actually the determinant of the acidity of blood or plasma. Normal cellular
metabolism requires an exacting environment where hydrogen ion concentration
must be maintained within narrow limits. Hydrogen ion activity reflects the
acid-base balance within blood. Acids are substances that donate hydrogen ions;
bases are substances that remove hydrogen ions from solution. The lungs, kidneys
and blood bases all work to maintain the acid-base status within the strict limits
for normal cell functioning.

Expressed in concentration units, hydroge

n ion concentrations are very small

numbers that are cumbersome to use. (For example, the common neutral pH of

7.00 is 0.0000001 mol/L.) In 1909 Sorenson converted the numbers
mathematically to simplify their use and described the notation pH:

where (H+) is the molar concentration of hydrogen ions.5

02087462 Rev. V

1-34 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

acid

base

pKpH log+=

acid

base

pH

α

Using this formula, a hydrogen ion concentration of 1 x 10-7 mol/L has a pH value of 7.
Because pH is the negative logarithm, its value is inversely proportional to the actual
hydrogen ion concentration in a sample. Therefore, as the hydrogen ion concentration
decreases, the pH value increases. As the hydrogen ion concentration increases, the pH
value decreases.

The normal pH range of human blood is 7.35–7.45.

The Henderson-Hasselbalch equation describes how pH expresses the interaction of acid
and base in

blood:

where K is the dissociation constant, which describes the ability to release hydrogen ions.

Because K, and thus pK, is a constant, this equation

can be used to demonstrate that pH is

proportional to the acid-base concentrations in blood:

Therefore, if base increases without a corresponding increase in acid, the pH rises, and if
acid increases without a corresponding increase in base, the pH decreases.

pH is clinically significant as a me

ans of determining acid-base disturbances. Acid-base
disorders can result in several pathologic conditions. Acidosis (low pH) stems from either
respiratory failure (high pCO

) or from metabolic causes (including ketoacidosis, lactic

2

acidosis, uremia, severe diarrhea, hypoaldosteronism, renal tubular disease, drug effects,
or poisoning from several specific agents). Alkalosis (high pH) stems from
hyperventilation (low pCO

) or from metabolic causes (including excessive vomiting,

2

gastric drainage, drug effects, hyperadrenocorticism, potassium depletion, or excessive
alkali intake). Extreme abnormalities of pH reflect a potentially life-threatening

pathophysiologic state that must be corrected promptly.

6,7

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-35

+−

+↔↔+ HHCOCOHOHCO

33222

pH Sensor

The pH sensor, which is based on ISE technology, is a half-cell that forms a
complete electrochemical cell when combined with the external reference sensor.
It contains a silver/silver chloride wire surrounded by a buffer solution. A glass
membrane that is highly sensitive and specific for hydrogen ions separates the
sample from the solution.

1 Buffer solution
2 Silver/silver chloride electrode
3 Sample path

Figure 1-30 pH Sensor

As the sample comes in contact with the membrane of the pH sensor, a membrane
potential develops due to the exchange of hydrogen ions in the membrane. The
silver/silver chloride inner conductor transmits the potential to a voltmeter where
it is compared to the constant potential of the reference sensor. The final measured
potential reflects the hydrogen ion concentration of the sample and is used to
report the pH value of the sample.

Carbon Dioxide Tension (pCO2)

Carbon dioxide (CO2) is produced during normal cell metabolism and is released
into the blood stream where it is transported to the kidneys and lungs for
excretion. CO
dissolved CO

is transported through the blood as bicarbonate (HCO

2

, and carbonic acid (H2CO3). CO2 exists in a dynamic state in the

2

blood as seen in the following equation:

–

),

3

02087462 Rev. V

1-36 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

acid

base

pKpH log+=

322

3

log

COHCO

HCO

pKpH

+

+=

−

32

3

COH

HCO

pH

−

α

The levels of HCO

–

, H2CO3, and dissolved CO2 play a major role in maintaining the pH

3

in blood. This relationship is best described through the Henderson-Hasselbalch equation:

Substituting HCO

–

as the base and dissolved CO2 and H2CO3 as the acid, the equation

3

reads as follows:

Taking the equation further, pH is seen as being proportional to the acid-base relationship:

Although other acids and bases are present in the blood, the H2CO3/HCO

–

relationship is

3

sensitive and dynamic and typically reflects other acid-base changes.

When the measurement of the partial

pressure of carbon dioxide (pCO2) in the blood is

combined with the measured pH, the values can be incorporated into the

–

Henderson-Hasselbalch equation to determine HCO
value is proportional to the content of dissolved CO
used along with pH not only to calculate HCO

3

and ctCO2. Because the pCO2

3

/HCO

2

–

but also to aid in the differentiation of

–

, the value for pCO2 can be

3

acid-base abnormalities.

This analyte reflects the overall respiratory status. Thus high pCO
suppression or failure, whereas low pCO

indicates hyperventilation (which in turn may

2

indicates respiratory

2

stem from hypoxia, anxiety, fever, cerebral disease, cirrhosis, or excessive mechanical
ventilation). Extreme abnormalities of pCO

pathophysiologic state that must be corrected promptly.

reflect a potentially life-threatening

2

6,7

Together, pH and pCO2 provide a more definitive diagnostic tool in assessing respiratory
function. An increase in the pCO
acidosis, a condition in which CO

value and a decrease in pH indicates respiratory

2

is retained by the lungs. A decrease in the pCO2 value

2

and an increase in pH indicates respiratory alkalosis, a condition in which the lungs are
expiring too much CO

relative to the amount produced.

2

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-37

+−

+↔+ HHCOOHCO

322

pCO2 Sensor

The pCO2 sensor is based upon the electrode described by Severinghaus and

8

Bradley.

The pCO2 sensor is a complete electrochemical cell that consists of a

measuring electrode and an internal reference electrode. The measuring electrode,
which is a pH electrode, is surrounded by a chloride bicarbonate solution. A
membrane permeable to gaseous CO

separates this solution from the sample. The

2

internal reference electrode, which contains a silver/silver chloride electrode
surrounded by the chloride-bicarbonate solution, provides a fixed potential.

1 Measuring electrode contact
2 Internal reference electrode contact (Ag/AgCl)
3 Sample path

Figure 1-31 pCO2 Sensor

As the sample comes in contact with the membrane, CO2 diffuses into the
chloride-bicarbonate solution, which causes a change in the hydrogen ion activity:

The internal pH electrode detects the change in hydrogen concentration occurring
in the chloride bicarbonate solution and generates a half-cell potential. This
potential, when compared to the fixed potential of the reference electrode, results
in a measurement that reflects pH change in the chloride bicarbonate solution. The
change in pH is related to the log of the partial pressure of CO

.

2

02087462 Rev. V

1-38 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Oxygen Tension (pO2)

Oxygen (O2) is essential for cell and tissue metabolism in the body. The cardiopulmonary
system is responsible for transporting oxygen to the cells. Oxygen transport involves 4

major steps: convection and diffusion from the air into the pulmonary circulation,
combination of O

O

through the arteries to the cell, and finally the release into the tissues and utilization of

2

at the cellular level.

O

2

Because it is not possible to measure intra-cellular oxygen tension (pO2), arterial pO2 has
become a standard for clinical evaluation of arterial oxygenation status. Measurement of

pO

(A), which indicates the oxygen tension in arterial blood, reflects the pressure or

2

driving force for moving oxygen from 1 location to the next due to pressure differential; it
is not a measurement of the O

pulmonary gas exchange efficiency from an arterial blood sample.

Complete laboratory evaluation of oxygenation often requires much more than simple
blood gas measurements. Assessment of ventilatory system and acid-base status is
essential to properly interpret clinical significance of arterial oxygenation status. However,
many patients can be evaluated and treated successfully using blood gases alone if clinical

observations and patient history are taken into account.

from the lungs with hemoglobin in red blood cells, transportation of the

2

content, but it provides a measurement tool to evaluate the

2

9

This analyte reflects the ability of the lungs to deliver oxygen to the blood. Hypoxia (low

) may occur despite adequate respiration due to parenchymal lung diseases

pO

2

(pneumonia, asthma, pulmonary edema, and pulmonary fibrosis) due to pulmonary
shunting of blood. Extremely low pO

state that must be corrected promptly.

is a potentially life-threatening pathophysiologic

2

6,7

The measurement of pO2 is significant in evaluating the degree of hypoxemia (a
deficiency of O
pO

is usually 95 mmHg (12.7 kPa) for a healthy young adult living near sea level.

2

However, as with pCO
action is indicated. Generally a pO

in arterial blood) present in a patient. The laboratory reference value for

2

and pH, a wider range of values may occur before any therapeutic

2

of 80 mmHg (10.7 kPa) signals therapeutically

2

significant hypoxemia. Above this value is very little change in oxygen saturation or
oxygen content with changes in oxygen tension, but below this value changes in saturation
can occur rapidly. Exceptions to this limit are newborns, who have an acceptable range of
40

to 70 mmHg (5.3 to 9.3 kPa) and adults over 50 years old, who have a normal

deterioration of lung function that causes a decrease in expected pO
1 mmHg (0.13 kPa) per year.

10

values of about

2

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-39

−−

→++ OHeOHO 442

22

−+

+→ eAgAg 44

pO2 Sensor

The pO2 sensor is based upon the electrode described by Clark.11 It is a complete
electrochemical cell that incorporates amperometric technology. The sensor

consists of a platinum (Pt) cathode, and silver (Ag) anode, an electrolyte solution,
and a gas-permeable membrane.

1 Cathode contact
2 Anode contact
3 Sample path

Figure 1-32 pO2 Sensor

A constant voltage, called a polarizing voltage, is maintained between the anode
and the cathode. As dissolved oxygen from the sample passes through the
membrane into the electrolyte solution, it is reduced at the cathode:

The circuit is completed at the anode, when the Ag is oxidized:

The amount of reduced oxygen is directly proportional to the number of electrons
gained at the cathode. Therefore, by measuring the change in current (electron
flow) between the anode and the cathode, the amount of oxygen in the electrolyte

solution is determined.

9

02087462 Rev. V

1-40 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Electrolytes

The Rapidlab 1260 and 1265 systems analyze blood samples for Na+, K+, Cl-, and Ca++ in
addition to pH and the blood gases. These systems also report the anion gap and a value
for calcium adjusted to pH of 7.40.

The sensors used for electrolytes are based on ion-selective electrode (ISE) technology.
Each sensor has a membrane that is highly selective for a specific ion.

1 Electrical contact
2 Electrolyte solution
3 Silver/silver chloride electrode

Figure 1-33 Electrolyte Sensor

The recognition mechanism in the ISE is the membrane. Each sensor has a membrane
selective for the specific substance that it measures.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-41

The potassium sensor membrane is designed as a charge separator. The positively
charged potassium ions selectively interact with the membrane when the sample
interfaces with the membrane. The negatively charged chloride ions do not
interact with the membrane. The charge separation causes the membrane potential
measured by the electrochemical cell.

1 Internal electrolyte solution
2 Membrane
3 Electrolyte solution
4 Randomly oriented ions

Figure 1-34 Illustrated Electrolyte Sensor

02087462 Rev. V

1-42 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Concentration of Sodium

Sodium (Na+) is the most abundant cation in the extracellular space in the body. Na+ is the
major determinant of extracellular osmotic regulation and plays a central role in
determining body fluid volume. The kidneys are the primary regulator of sodium and
consequently water volume; only minimal amounts of sodium are lost through the skin
and other insensible sites. Two regulatory hormones, aldosterone and the antidiuretic
hormone (ADH), affect kidney function and hence sodium balance. Aldosterone
stimulates the kidneys to reabsorb sodium; ADH stimulates the kidneys to reabsorb water.
Maintaining sodium homeostasis is essential in order to regulate body fluids, maintain
electrical potential in muscle cells, and control cellular membrane permeability.

Abnormal concentrations of Na+ stem from deficit or overload of total body water or of
sodium itself. These abnormal concentrations arise from diverse clinical conditions, such
as congestive heart failure, liver disease (cirrhosis), renal disease, neuropsychiatric
disorders (causing abnormal fluid intake), intravenous fluid therapy, excessive fluid loss
(vomiting, diarrhea, heat stroke), drug therapy (diuretics), diabetes mellitus (causing
osmotic diuresis), and imbalances of hormones (ADH, mineralcorticoid, glucocorticoid)
that regulate sodium and water excretion. An extremely abnormal plasma sodium
concentration may itself directly cause altered mental status, stupor, coma, seizures, brain
swelling, brain dehydration leading to cerebral hemorrhage or, ultimately, death. Thus
extreme abnormalities of sodium reflect a potentially life-threatening pathophysiologic

6,12

state that must be corrected promptly.

Sodium Sensor

The sodium sensor is a half-cell that combines with the external reference sensor to form a
complete electrochemical cell. The sensor contains a silver/silver chloride wire
surrounded by an electrolyte solution that has a fixed concentration of sodium and
chloride ions. The membrane, a specially formulated glass capillary that is highly selective
for sodium ions over other clinically encountered cations, separates the electrolyte
solution from the sample.

As the sample comes in contact with the membrane of the sensor, a potential develops due
to the exchange of sodium ions in the membrane. The potential developing across the
membrane is compared to the constant potential of the external reference sensor. The final
measured potential is proportional to the sodium ion concentration in the sample. The
potential developed by the electrochemical cell varies with the ion activity in each sample.

Concentration of Potassium

Potassium (K+) is the major intracellular cation. K+ plays an important role in maintaining
cell membrane potential in neuromuscular tissue. The normal level within cells is
150 mmol/L, while the normal extracellular potassium level is only 4 mmol/L. A depletion
of extracellular potassium causes an increase in the transmembrane electrical potential
gradient, which impedes the impulse formation and propagation involved in muscle
contraction.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-43

Most potassium is excreted by the kidney, which is the major regulator of
potassium output in the body. Actually, the kidney is better at conserving sodium
and excreting potassium so in cases where potassium intake stops, the kidney
requires time to adjust and stop excreting potassium. Two hormones, insulin and
aldosterone, can affect the extracellular level of potassium. Both insulin and
aldosterone influence intercellular uptake of potassium, while aldosterone causes
increased potassium excretion through the kidney.

High concentrations of K+ commonly stem from renal insufficiency (or failure),
excessive potassium replacement, drug effects (including some diuretics),
hemolytic disease, or crush injury. Low concentrations stem from gastrointestinal
loss, dietary insufficiency, or drug effects (most diuretics). Other metabolic
imbalances (acid-base, mineralcorticoid, glucocorticoid, insulin effects) also
cause abnormal potassium concentrations. An extremely abnormal plasma
potassium concentration may itself directly cause neuromuscular paralysis,
respiratory failure, cardiac arrhythmia, or cardiac arrest. Thus extreme
abnormalities of potassium reflect a potentially life-threatening pathophysiologic

state that must be corrected promptly.

6,12

Potassium Sensor

The potassium sensor is a half-cell that combines with the external reference
sensor to form a complete electrochemical cell. The sensor contains a silver/silver
chloride wire surrounded by an electrolyte solution that has a fixed concentration
of potassium ions. The membrane, which consists of the ionophore valinomycin
immobilized in a plasticized PVC (polyvinyl chloride) matrix, separates the
electrolyte solution from the sample. Valinomycin is a neutral ion carrier that is
highly selective for potassium ions over other clinically encountered cations.

As the sample comes in contact with the membrane of the potassium sensor, a
membrane potential is created by the interaction of potassium ions with the
membrane. The potential developing in the potassium sensor is compared to the
constant potential of the external reference sensor. The final measured potential is
directly proportional to the potassium ion concentration in the sample. The
potential developed by the electrochemical cell varies with the ion activity in each
sample.

Concentration of Chloride

Chloride (Cl-) is the major extracellular anion in the body. Cl- plays a large role in
maintaining electrical neutrality and normal osmolality, and it participates in the
regulation of acid-base balance. The kidneys are the main regulator of chloride in
the body. Serum levels of chloride usually correspond to increases and decreases
of sodium. Clinically, the serum chloride level alone is rather meaningless. A
change in chloride level does not reveal much about a patient’s condition; it must
be viewed as part of the overall fluid and electrolyte status.

02087462 Rev. V

1-44 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

This assay is used most commonly to distinguish high-anion-gap acidoses (ketoacidosis,
lactic acidosis, uremia, poisoning from several specific agents) from hyperchloremic
acidoses (loss of alkali as in severe diarrhea, hypoaldosteronism, potassium-sparing
diuretics, renal tubular acidosis). In the absence of acidosis, changes in plasma chloride
concentration tend to parallel those of sodium. Thus chloride is high in dehydration and

low in overhydrated states.

Chloride Sensor

7,13

The chloride sensor is a half-cell that combines with the external reference sensor to form
a complete electrochemical cell capable of measuring chloride concentration in a sample.
The sensor contains a silver/silver chloride wire surrounded by an electrolyte solution that
has a fixed concentration of chloride ions. The membrane is a derivitized quaternary
ammonium compound that is immobilized in a polymer matrix. It acts as an ion exchanger
with a high selectivity for chloride ions over other ions present in the sample, and
separates the electrolyte solution from the sample.

As the sample comes in contact with the membrane of the chloride sensor, chloride ion
exchange occurs at the membrane and creates a membrane potential. The potential that
develops in the chloride sensor is compared to the constant potential of the external
reference sensor. The final measured potential is directly proportional to the chloride ion
concentration in the sample. The potential developed by the electrochemical cell varies
with the ion activity in the sample.

Concentration of Ionized Calcium

Ionized calcium (Ca++) is the physiologically active form of calcium, which comprises
approximately 45% of the total calcium in plasma. Ca
smooth vascular muscle and plays a vital part in cardiovascular function. Ca

important in muscle function, nerve function, and bone formation, and it is a cofactor in
many cellular hormone and enzyme reactions.

The action of the parathyroid hormone (PTH) — 1,25 dihydroxyvitamin D (1,25D) — and
calcitonin closely controls the concentration of calcium in extracellular fluid, and
regulates the transport of calcium across the gastrointestinal tract, kidney, and bone.
Calcium is one of the most tightly controlled analytes in the body with fluctuations of less

than 5% occurring about the mean during a 24-hour period.

Ca++ abnormalities typically stem from parathyroid disease, vitamin D imbalance, renal
disease, pancreatitis, drug effects, abnormalities of magnesium or phosphorus,

malignancy, or sarcoidosis. An extreme abnormality of Ca
symptoms, tetany, altered mental status, seizures, heart failure, or arrhythmias. Thus
extreme abnormalities of ionized calcium reflect a potentially life-threatening

pathophysiologic state that must be corrected promptly.

++

is essential for the contractility of

++

is also

14

++

may cause neuromuscular

6,15

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-45

When measuring ionized calcium, pH should also be measured. Because
hydrogen ions compete with calcium for calcium binding sites, a change in
sample pH can have a direct effect on calcium levels. For example, a change in pH
of 0.1 can cause a change in calcium of 0.2

normal range. Its effects, if not taken into account, are clearly significant.

Calcium Sensor

mg/dL, which exceeds the span of the

16

The calcium sensor is a half-cell that combines with the external reference sensor
to form a complete electrochemical cell capable of measuring calcium levels in a
blood sample. The sensor contains a silver and silver chloride wire surrounded by
an electrolyte solution that has a fixed concentration of calcium ions. A
membrane, consisting of an ionophore imbedded in a polyvinyl chloride
membrane, separates the electrolyte solution from the sample. The ionophore is a
compound that is highly selective for calcium ions over other ions.

When the sample comes in contact with the membrane of the measuring sensor, a
membrane potential develops as calcium ions interact with the membrane. This
membrane potential is compared to the constant potential of the external reference
sensor. The final measured potential is proportional to the calcium ion
concentration in the sample. The potential developed by the electrochemical cell
varies with the ion activity in each sample.

Metabolites

The Rapidlab 1260 and 1265 systems analyze blood samples for glucose and
lactate in addition to pH, blood gases, and electrolytes.

Concentration of Glucose

Glucose is the fundamental molecule in carbohydrate metabolism. Carbohydrates,
which provide a major food supply and energy source for the body, are broken
down into simple sugars such as glucose. Glucose is then absorbed through the
intestine, passes through the liver, and eventually enters the vascular system
where it reaches the cell level to be used as fuel.

A number of factors influence the level of blood glucose. Dietary intake has a
direct effect on glucose concentration. Blood levels of glucose will fluctuate
depending on nutritional condition and the time of day when a sample is taken.
Insulin, a hormone produced by specialized cells in the pancreas, plays an
important role in regulating the blood level of glucose. By promoting
glycogenesis (conversion of glucose to glycogen) and by increasing the
permeability of cells to glucose, insulin can decrease blood glucose levels.

02087462 Rev. V

1-46 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Determining the blood glucose level is helpful in diagnosing many metabolic diseases.
Glucose is elevated in any of the forms of diabetes mellitus, including Type 1, Type 2,
Gestational, or any of the 50 other specific types. More moderate elevations occur in
pre-diabetic conditions known as impaired glucose levels. Diabetics sometimes suffer
acute, life-threatening metabolic crises, such as diabetic ketoacidosis that is typical in
Type 1 or hyperglycemic hyperosmolar nonketotic state that is typical in Type 2. Low
glucose levels most commonly stem from insulin overdose, but also from a number of
disorders collectively known as hypoglycemic disorders. Examples of the latter include
insulinoma, IGF

-secreting tumor, factitious hypoglycemia, postprandial syndrome,

2

severe hepatic disorders, endocrine disorders characterized by deficiencies in
gluconeogenic hormones, and some post-surgical gastric states. Extreme abnormalities of
glucose reflect a potentially life-threatening pathophysiologic state that must be corrected

promptly.

6,17,18

Concentration of Lactate

Lactate acid is an intermediary product of the anaerobic metabolism of glucose.
Glycolysis is the term commonly used to describe the conversion of glucose to lactic acid.
Under normal circumstances, glycolysis occurs during muscle contraction where the rate
of metabolism outpaces the oxygen supply in the cells. During strenuous exercise, the
level of lactic acid increases significantly and passes to the blood where it is transported to
and metabolized by the liver. In normal aerobic conditions, the lactic acid is readily
oxidized in the cell to pyruvic acid, which is eventually degraded to CO

and H2O.

2

The concentration of lactate in the blood is affected by the rate of production, the rate of
metabolism, and the availability of oxygen at the cell level.

Determining the blood lactate level is helpful in assessing the supply of oxygen at the
tissue level. Increased oxygen deprivation causes the normal oxidation of pyruvic acid to
lactate and can cause severe acidosis called lactic acidosis. This condition is characterized
by increased lactate levels and an increased lactate:pyruvic ratio in the blood due to the
lack of cellular oxidative process. Elevations of lactate are a sign of inadequate delivery of
oxygen to the peripheral tissues as occurs in respiratory failure, circulatory failure, and

clinical shock.

7

Glucose and Lactate Biosensors

The glucose and lactate biosensors are complete electrochemical cells that incorporate
amperometric technology to measure glucose or lactate concentration in samples. The

biosensors consist of 4 electrodes.

1 Platinized activated carbon electrode technology license from Cambridge Life Sciences plc. under U.S. Patent Nos 4,970,145

and 5,160,418 and foreign counterparts.

1

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-47

22

)(

712622

)(

6126

OHOHCOOHOHC

acidgluconic

GOX

glucose

+++

→

The measuring electrode contains platinum and glucose oxidase or lactate oxidase
in a binder, while the reference electrode is composed of Ag/AgCl. Two other
electrodes are also present. The counter electrode is a Pt (platinum) conductor that
ensures a constant applied potential. Another measuring electrode, without the
enzyme, determines interfering substances in the sample. The potential from
interfering substances is removed from the total differential measurement. A
microporous cover membrane separates the electrodes from the sample.

1 Glucose or lactate measuring electrode
2 Reference electrode
3 Interference measuring electrode
4 Counter electrode
5 Sample path

Figure 1-35 Glucose and Lactate Biosensor

A constant voltage, called a polarizing voltage, is maintained during analysis. In
the glucose sensor, glucose from the sample interacts with the glucose oxidase on
the surface of the measuring electrode to form hydrogen peroxide and gluconic
acid:

where GOX is the glucose oxidase.

The polarizing voltage is sufficient to cause ox

idation of the hydrogen peroxide to

oxygen:

02087462 Rev. V

−+

++→ eOHOH 22

222

1-48 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

22

)(

34322

)(

363

OHOHCOOHOHC

acidpyruvic

LOD

acidlactic

+++

→

−+

++→ eOHOH 22

222

The loss of electrons in the oxidation of H2O2 creates a current flow that is directly
proportional to the glucose concentration in the sample.

In the lactate sensor, lactic acid from the sample

interacts with the lactate oxidase on the

surface of the measuring electrode to form pyruvic acid and hydrogen peroxide:

where LOD is the lactate oxidase.

The polarizing voltage is sufficient to cause oxidation of the hydrogen peroxide to oxygen:

The loss of electrons in the oxidation of H2O2 creates a current flow that is directly
proportional to the lactate concentration in the sample.

Hemoglobin and its Derivatives

Hemoglobin analysis yields important information necessary to assess the function of the
oxygen transport system. The need for hemoglobin determinations led to the development
of a number of methods to determine the concentration of total hemoglobin, hemoglobin
derivatives, and dyshemoglobins in human whole blood. The presence of dyshemoglobins
and toxins changes the oxygen binding capacity of hemoglobin and therefore its ability to

transport oxygen.

19

Hemoglobin is a tetrameric protein consisting of 2 pairs of polypeptide chains, each chain
having a heme group containing 1 atom of iron. Each molecule of hemoglobin can bind up
to 4 molecules of oxygen, 1 at each heme group. Hemoglobin has a key role in the
transport of oxygen from the lungs to the tissues and the transport of carbon dioxide from
the tissues to the lungs.

The ability of hemoglobin to bind and release oxygen depends on several factors: pH,

, pO2, 2, 3-diphosphoglycerate concentration, and temperature.

pCO

2

20

The presence of dyshemoglobins (hemoglobins not available for reversible binding with
oxygen), such as carboxyhemoglobin, methemoglobin, and sulfhemoglobin, may also

affect the normal oxygen transport mechanism.

02087462 Rev. V

21

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-49

Hyperlipemia can result in artificially increased methemoglobin values.

22,23

High
bilirubin concentrations can falsely increase oxyhemoglobin values. Hyperlipemia
and administration of fat emulsions can increase total hemoglobin values.
Samples frozen with liquid nitrogen can have decreased total hemoglobin

levels.23 Samples from patients receiving blood substitutes yield unreliable results
for oxygen content because of the different oxygen solubility of the blood
substitutes.

Total Hemoglobin

Total hemoglobin (tHb) is the total of all measured hemoglobin fractions.21 Total
hemoglobin determination is important in the assessment of oxygen transport and
in the evaluation of anemia. The total hemoglobin reference range for a normal
adult population is 12.0 to 18.0 g/dL.

Total hemoglobin in the CO-ox module is determined using
equation:

tHb = FO

In anemia, hemoglobin is low. Numerous spec

Hb + FHHb + FMetHb + FCOHb

2

ific types of anemia exist but each
stems from 1 of 3 basic causes: Blood loss, destruction of red blood cells, or
failure to produce new red blood cells. In polycythemia, hemoglobin is high.
Polycythemia may be primary, secondary to hypoxia, secondary to dehydration, or
a complication of over-transfusion. Polycythemia may lead to circulatory
complications as a result of increased blood viscosity. Extreme abnormalities of
hemoglobin reflect a potentially life-threatening pathophysiologic state that must

be corrected promptly.

6,24,25

the following

Oxyhemoglobin

Oxyhemoglobin (O2Hb) is the fraction of hemoglobin that is actually delivering
oxygen to body tissues.

26

Oxyhemoglobin is reversibly bound to oxygen.21 The
oxyhemoglobin reference range for arterial blood for a normal population is 94.0
to 97.0%.

The percent of oxyhemoglobin is determined using the following equation:

Hb = cO2Hb / ctHb x 100

FO

2

Deoxyhemoglobin

Deoxyhemoglobin (HHb) refers to the hemoglobin capable of binding oxygen.

21

Deoxyhemoglobin is sometimes referred to as reduced hemoglobin.
deoxyhemoglobin reference range for arterial blood for a normal population is 0.0
to 5.0%.

The

02087462 Rev. V

1-50 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

The percent of deoxyhemoglobin is determined using the following equation:

FHHb =

This is the fraction of hemoglobin that could
pulmonary oxygenation were improved.

cHHb / ctHb x 100

deliver more oxygen to body tissues if

26

Methemoglobin

This is a fraction of hemoglobin that cannot deliver oxygen to body tissues and is elevated
in certain metabolic diseases.

hemoglobin Hi, is hemoglobin whose iron is oxidized to its ferric state [FE(III)] and is
unable to bind oxygen. High methemoglobin concentrations, a condition called
methemoglobinemia, can produce hypoxia and cyanosis. Methemoglobinemia can be the
result of hereditary conditions or of exposure to toxic substances such as nitrates, nitrites,

aniline dyes and their derivatives, and topical anesthetics such as benzocaine.
and other individuals with significant fetal hemoglobin concentrations show increased
susceptibility to methemoglobinemia because fetal hemoglobin converts to

methemoglobin more readily than adult hemoglobin.
range for arterial or venous blood for a normal population is 0.0 to 1.5%.

The percent of methemoglobin is determined using the

FMetHb = cMetHb / ctHb

26

Methemoglobin (MetHb), which is sometimes known as

21

The methemoglobin reference

following equation:

x 100

19,27

Infants

Carboxyhemoglobin

Carboxyhemoglobin (COHb) is hemoglobin covalently bound to carbon monoxide.
Hemoglobin has over 200 times greater affinity for carbon monoxide than for oxygen.
Hemoglobin bound to carbon monoxide is unavailable for oxygen transport, and high
levels of carboxyhemoglobin result in hypoxia and cyanosis, which can be fatal.

The carboxyhemoglobin reference ran
the amount of carboxyhemoglobin in the blood of healthy nonsmokers is very small
(between 0.1% and 0.4%), smoking, air pollution, and occupational exposure to carbon

monoxide affect COHb levels.

19

The percent of carboxyhemoglobin is determined using the following equation:

FCOHb = cOHb / ctHb

x 100

ge for a normal population is 0.0 to 1.5% . While

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-51

Sulfhemoglobin

Sulfhemoglobin (SulfHb) is a stable compound of hemoglobin and sulfur. This is
a fraction of hemoglobin that cannot deliver oxygen to body tissues and may be
elevated in some patients taking sulfur-containing drugs or with certain

26

infections.
often be accompanied by methemoglobinemia. The presence of sulfhemoglobin
affects oxyhemoglobin values and other quantities if its absorbance spectrum is

not accounted for.
is 0.0 to 2.2%.

Sulfhemoglobin has an extremely low affinity for oxygen and may

19

The sulfhemoglobin reference range for a normal population

The CO-oximeter (CO-ox) module detects and indica

tes concentrations of

sulfhemoglobin greater than 1.5%.

Determination of Hemoglobin Derivatives

Hemoglobin derivatives have characteristic absorbance spectra. Each derivative
absorbs light differently at different wavelengths. Similarly, interfering substances
also absorb light at known wavelengths.

The spectral absorption method determines concentration using
For each substance or fraction, the absorbance at a specific wavelength is equal to
the product of the path length, concentration of the fraction or substance, and the
molar absorptivity or the extinction coefficient for that substance, as shown in the
following equation:

= ε1C1 + ε2C2 +... εnCn

A

x

where A

is the absorbance at a specific wavelength, ε is the major extinction

x

coefficient for that fraction or substance at a specific wavelength, and C is the
concentration of the substance.

These equations are based on the work of
Benesch, and Yung.

29

VanAssendelft

28, 29

matrix equations.

and Benesch,

02087462 Rev. V

1-52 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Before reaching the sample chamber, a portion of the light is diverted to a photodiode
feedback sensor located on the main circuit board. The photodiode sensor provides
electrical feedback to the lamp’s control circuit to control the lamp’s output intensity. The
cable that connects the components of the measurement module is a multi-fiber bundle
containing hundreds of fibers designed to deliver light that is uniformly distributed over
the fiber face.

The sample chamber has a sliding cell design that opens and closes to allow for
measurement. The sample chamber also contains a thermistor to control the temperature
of the sample during measurement and a detector mechanism to sense the position of the
chamber cell.

The polychromater separates the sample into its component wavelengths. The
polychromater measures the intensity of light at the different wavelengths and converts the
electrical signal to a digital value for further processing.

The wavelength calibrator consists of a neon lamp, lenses, and a filter. The neon lamp
emits a stable emission spectrum that is used to test the alignment of the polychromater.
The system makes adjustments to maintain alignment of the polychromator.

Parameters

NOTE: The parameters that your system reports depend on the sensors available on the

system and the parameters selected in Setup.

The Rapidlab 1200 systems provide results for the following parameters:

Parameters Results Description

Blood Gases pCO

Electrolyte

Metabolic HCO

2

pO

2

+

-

+

++

++

+

(7.4)

pH or H

*

Na

K

Ca

Cl

Ca

partial pressure of carbon dioxide

partial pressure of oxygen

hydrogen ion concentration (expressed as pH or

+

H

)

sodium

potassium

calcium ion concentration

chloride

calcium adjusted for pH

AnGap estimated difference of unmeasured cations and

unmeasured anions

¯act actual bicarbonate

3

¯std standard bicarbonate

HCO

3

BE(B) base excess of blood

02087462 Rev. V

BE(ecf) base excess of extracellular fluid

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-53

Parameters Results Description

Oxygenation O

ctCO

2

SAT(est) oxygen saturation (estimated)

2

CT(est) oxygen content (estimated)

O

2

†

Hct

total carbon dioxide

hematocrit calculated from tHb

Metabolites

*

Temperature
Corrected

a-v Study
Parameters

†

CO-oximetry
Parameters

†

pO

2/FIO2

arterial pO2 to fraction of inspired O2 ratio

Glu glucose

Lac lactate

pH(T), H

pCO

pO

+

(T)

(T) partial pressure of carbon dioxide

2

(T) partial pressure of oxygen

2

temperature corrected pH

RI(T) respiratory index

(A-a)(T) alveolar-arterial oxygen tension diff

pO

2

(a/A)(T) alveolar-arterial oxygen tension ratio

pO

2

Qsp/Qt(T)

†

Qsp/Qt(T)(est)

physiologic shunt

†

estimated physiologic shunt

ctO2(a) arterial oxygen content

(v) venous oxygen content

ctO

2

( ) mixed venous oxygen content

ctO

2

(Hb) oxygen content of hemoglobin

ctO

2

O

2

O

2

([a- ]/a) a-v extraction index

ctO

2

(a- ) arterial-mixed venous oxygen content

ctO

2

oxygen consumption rate

oxygen delivery

difference

tHb total hemoglobin

FO

Hb oxyhemoglobin

2

FCOHb carboxyhemoglobin

FMetHb methemoglobin

FHHb deoxyhemoglobin

sO

2

hemoglobin oxygen saturation

02087462 Rev. V

1-54 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

(

[

]

(

[

]

31.065.29.2

9.05.24

2

3

tHBA

AstdHCO

×+−

+×+=

−

()

()(

1002.0

2

estSATOtHB

BBEA

−

×

−=

Parameters Results Description

BO

2

p50 oxygen tension at 50% saturation

* Indicates parameters available only on Rapidlab 1260 and Rapidlab 1265 systems.
† Indicates parameters available only on Rapidlab 1245 and Rapidlab 1265 systems.

The sections that follow briefly describe the clinical significance of each of these
parameters.

oxygen binding capacity

Bicarbonate Ion

The majority of CO2 is transported through the body as the bicarbonate ion (HCO
which is the major buffer substance present in the body. Bicarbonate plays a central role in

maintaining the pH level in blood.

Bicarbonate levels are clinically significant in helping to determine the nonrespiratory,
renal (metabolic) component in acid-base blood disorders.

Two versions of bicarbonate exist:

• Actual bicarbonate (HCO
values, based on the recommendations from the Clinical and Laboratory Standards

Institute (CLSI) as follows:

–

HCO

• Standard bicarbonate (HCO
concentration if the blood is equilibrated to a pCO
described by VanSlyke and Cullin

act = 0.0307 × pCO2 × 10

3

–

act), which is determined directly from the pH and pCO2

3

(pH(37)–6.105)

–

std), which is a determination of the plasma HCO

3

of 40 mmHg9 using the equation

2

30

:

)

)

–

),

3

–

3

1000

where

×

)

100

and if sO2 is available, it is used in place of O2SAT(est).

NOTE: If ctHb is not available as an entered value or a measured value, the system uses

15 g/dL as a default value.

Base Excess

Base excess is an empirical expression that approximates the amount of acid or base
required to titrate 1 liter of blood to a normal pH of 7.40. Base excess is a clinically useful

way of assessing the metabolic portion of the acid-base balance.

02087462 Rev. V

9

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-55

Base excess permits the estimation of the number of equivalents of sodium
bicarbonate or of ammonium chloride required to correct the blood pH to normal.
A negative value for base excess indicates a base deficit.

Two versions of base excess exist:

• Base excess of extracellular fluid [BE(ecf)], formerly known as in vivo base
excess, determined as follows:

BE(ecf) = HCO

–

act–24.8 + (16.2 × (pH(37)–7.40))

3

• Base excess of blood (BE(B)), formerly known as in vitro base excess,
determined as follows:

BE(B) = (1–0.014 × tHb) × [(HCO

–

act–24.8) + ((7.7 + 1.43 × tHb) ×

3

(pH(37)–7.40))]

NOTE: If ctHb is not available as an entered value or a measured value, the

system uses 15 g/dL as a default value.

The equations for base excess are derived from CLSI recommendations.

19

Total Carbon Dioxide

Total carbon dioxide (ctCO2) is the sum of the dissolved carbon dioxide and the
plasma bicarbonate. When evaluated with pH and pCO

, total carbon dioxide is

2

useful in distinguishing between metabolic and respiratory acid-base disorders.

The system determines total carbon dioxide according to the following equation:

ctCO2 = (0.0307 × pCO2) + HCO

–

act

3

Hematocrit

Hematocrit (Hct) is the ratio of the volume of packed red blood cells to the
volume of human whole blood. Hematocrit, with other parameters such as total
hemoglobin, is useful in the evaluation of anemia.

The estimated hematocrit value is determined using the following equation:

Hct = ctHb × 2.941

where 2.941 is a factor calculated by dividing 100 g/dL by a normal MCHC
(mean corpuscular hemoglobin concentration) of 34%.

Estimated hematocrits should not be used as the sole consideration in the
diagnosis of hematological disorders.

02087462 Rev. V

1-56 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

0.019

CO log

correction CO

2

2

=

Δ

=

p

p

2.30 O 10 9.72

0.071 O 10 5.49

T

CO log

correction CO

3.88

2

9–

3.88

2

–11

2

2

+××

+××

=

Δ

Δ

=

p

pp

p

Patient Temperature Correction

The Rapidlab 1200 systems measurements and determinations are based on a standard
temperature of 37.0°C. During sample analysis, you can enter the actual patient
tempera
pH, pCO

ture value, which enables the system to provide temperature-corrected results for

, and pO2.

2

The system determines temperature-corrected result
factors:

19

s using the following correction

pH correction = ΔpH / ΔT = –0.0147 + 0.0065(7.4–pH)

Δ

T

Hemoglobin Oxygen Saturation

Hemoglobin oxygen saturation (sO2) is a ratio of the amount of hemoglobin bound to

19

oxygen to the total amount of hemoglobin able to bind oxygen.
saturation, with oxygen content and oxygen capacity, is a useful parameter for determining
the amount of oxygen in the blood that is actually available to the tissues and for
determining the effectiveness of oxygen therapy.

Hemoglobin oxygen saturation, expressed as a percent,

is determined using the following

equation:

Hemoglobin oxygen

= (100 x FO2Hb) / (FO2Hb + FHHb)

sO

2

Oxygen Content

Oxygen content is the concentration of the total oxygen carried by the blood, including
oxygen bound to hemoglobin as well as oxygen dissolved in plasma and in the fluid within
red cells.

Clinically, dissolved oxygen is unimportant for most
levels of hemoglobin or in patients receiving hyperbaric oxygen therapy, dissolved oxygen
may be a very significant contributor to oxygen content and thus to oxygen transport.

Oxygen content is determined, using CLSI recommendations, from the
relationship:

= (FO2Hb ×1.39 × ctHb + 0.00314 × pO2)

ctO

2

where ctHb is ex

02087462 Rev. V

pressed in g/dL and FO2Hb is decimal.

situations. However, at very low

following

19

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-57

If FO2Hb is unavailable, oxygen content is derived from estimated oxygen
saturation [O

SAT(est)] according to the following equation:

2

O2CT = (1.39 × ctHb × O2SAT(est)/100)+ (0.00314 × pO2)

If ctHb is not measured or entered, O2CT is not displayed or printed.

NOTE: Clinically significant errors can result from incorporating an estimated

value for oxygen saturation in further calculations, such as oxygen content and
shunt fraction (Q

equivalent to fractional oxyhemoglobin.

), or by assuming that the value obtained [O2SAT(est)] is

sp/Qt

19

Oxygen Content of Hemoglobin

The oxygen content of hemoglobin, ctO2(Hb), is the volume of oxygen actually
bound to hemoglobin.

oxygen saturation and oxygen capacity, is a useful parameter for determining the
amount of oxygen in the blood that is actually available to the tissues and for
determining the effectiveness of oxygen therapy.

19

The oxygen content of hemoglobin, with hemoglobin

The oxygen content of hemoglobin for a sample when pO2 is not available is
determined using the following equation:

ctO2(Hb) = (OBF × tHb × FO2Hb)

where OBF is the O2 binding factor. The system uses the default value of 1.39, or
whatever value is entered as the default value in Setup. FO

Hb is in decimal

2

format.

Oxygen Capacity of Hemoglobin

The oxygen capacity of hemoglobin (BO2) is the maximum amount of oxygen
that the hemoglobin in a given quantity of blood can carry. This value represents

the potential of hemoglobin to bind to oxygen and includes all the oxygen that can

19

be bound to the available hemoglobin.
with hemoglobin oxygen saturation and oxygen content, is a useful parameter for
determining the amount of oxygen in the blood that is actually available to the
tissues and for determining the effectiveness of oxygen therapy.

The oxygen capacity of hemoglobin is determined using the following equation:

BO2 = OBF x tHb x (FO2Hb + FHHb)

where OBF is the O2 binding factor. The system uses the default value of 1.39, or
whatever value is entered as the default value in Setup. FO
decimal format.

The oxygen capacity of hemoglobin,

Hb + FHHb are in

2

02087462 Rev. V

1-58 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

()

100*

104.2311002400015

2000204515

6234

234

2

×+−+−

++−

=

NNNN

NNNN

estSATO

p50

Half saturation of hemoglobin by oxygen (p50) indicates the partial pressure of oxygen
when oxygen has saturated 50% of the available hemoglobin. The p50 value indicates the

21

position of the oxygen-hemoglobin dissociation curve:

•Low p50 shifts

the curve to the left and indicates increased oxygen-hemoglobin

affinity

•High p50 shifts the curve to the right and indicates decreased oxygen-hemoglobin
affinity

The p5

0 value is useful in indicating the presence of abnormal hemoglobin that affects the

oxygen transport mechanism, and as an indirect measure of the 2,3 DPG concentration.
The p50 can also indicate changes in pH, pCO

, and temperature.

2

19,21

The p50 value is reported for sO2 values between 20% and 90% and is determined using
the following equation:

p50 = 26

.6 x (pO2c / pO2s)

where

pO

c = pO2 × 10

2

and pO

s is calculated with an interactive program.31

2

–[0.48 x (7.4–pH(37)) + 0.0013BE(B)]

Oxygen Saturation (Estimated)

Oxygen saturation is a ratio, expressed as a percentage, of the volume of oxygen carried to
the maximum volume of oxygen that the hemoglobin can carry. When combined with
knowledge of oxygen content, oxygen saturation is useful for evaluating the amount of
oxygen actually available for the tissues. Oxygen saturation can also be used to evaluate

e effectiveness of oxygen therapy.

th

The system estimates oxygen saturation using t
Thomas

33

as follows:

he relationship described by Kelman32 and

02087462 Rev. V

where

N = pO

[0.48(pH(37)–7.4)–0.0013 BE(B)]

× 10

2

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-59

Estimated oxygen saturation [O2SAT(est)] does not account for variations in
2,3

DPG levels, carbon monoxide levels, or the presence of other
dyshemoglobins. Therefore, clinically significant errors can result from
incorporating an estimated value for oxygen saturation into further calculations,
such as oxygen content and pulmonary shunt, or by assuming that the value

obtained is equivalent to fractional oxyhemoglobin.

19

pO2/FIO

2

The pO2/FIO2 ratio is an index of the efficiency of pulmonary oxygen exchange
that relates the arterial pO

to the fraction of inspired oxygen.

2

34

Calcium Adjustment for pH

The ionized calcium concentration is dependent upon sample pH. The calcium

++

value adjusted to pH of 7.40 [Ca

(7.4)] reflects the true ionized calcium

concentration of blood normalized to pH 7.40.

The system adjusts the calcium value according to the following equation:

++

Ca

(7.4) = Ca++ × 10

[–0.178 × (7.40–pH(37))]

35

The calcium value is adjusted only when pH at 37°C is between 7.2 and 7.7,
because no reliable, published clinical data is available for correction at values

outside this

range.

35

Anion Gap

The anion gap (AnGap) is an approximation of the difference between
unmeasured cations and unmeasured anions in the sample and is useful in

determining the cause of metabolic acidosis.

35

An abnormal anion gap indicates electrolyte imbalance or other conditions where
electroneutrality is disrupted, such as diabetes, ingestion of toxins, lactic acidosis,
and dehydration.

The system determines the anion gap as follows:

AnGap = (Na+ + K+)–(Cl- + HCO

–

act)

3

02087462 Rev. V

1-60 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Gas Exchange Indices

Gas exchange indices are a quick way to estimate the relationship between pulmonary
dysfunction and hypoxia, and to quantitatively determine the degree of pulmonary
shunting. The primary benefit of using gas exchange indices is that they are easy to derive
at the bedside. However, they do not have a high level of correlation with the actual
measurement of arterial and mixed venous blood and should be used with discretion. A

more reliable method is the

and oxygen content.

pO

2

The gas exchange indices are provided with

sp/ t shunt fraction, which is based on measurements of

the Rapidlab 1200 systems for convenience.

Final judgment of their use is at the discretion of the physician.

All gas exchange indices require an arterial sample and

use measured values at patient

temperature.

Alveolar-Arterial Oxygen Tension Difference

The alveolar-arterial oxygen tension difference, pO2(A-a), which is sometimes
abbreviated as A-aDO

, is useful as an index of gas exchange within the lungs if the ctO

2

measurements are not available. The following equation36 is used:

(A-a)(T) = pO2(A)(T)–pO2(a)(T)

pO

2

where pO
pO

2

(A)(T) is the temperature corrected oxygen tension of alveolar gas and

2

(a)(T) is the temperature corrected oxygen tension of arterial blood.

Arterial-Alveolar Oxygen Tension Ratio

The arterial-alveolar oxygen tension ratio, pO2(a/A), which is also referred to as the a/A
ratio, provides an index of oxygenation that remains relatively stable when F
This ratio is useful in predicting oxygen tension in alveolar gas. The following equation is

37

used:

IO2

changes.

2

02087462 Rev. V

pO2(a/A)(T) = pO2(a)(T) / pO2(A)(T) × 100

where pO
pO

2

(a)(T) is the temperature corrected oxygen tension of arterial blood and

2

(A)(T) is the temperature corrected oxygen tension of alveolar gas.

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-61

Respiratory Index

The respiratory index (RI(T)) is the ratio of the alveolar-arterial blood
oxygen-pressure difference to arterial pO

for patient temperature. This index is also a means of as
pulmonary shunting.

19

The system determines respiratory index as follows:

, when both values are corrected

2

sessing the degree of

RI(T) = pO

where pO
difference and pO

(A-a)(T) / pO2(a)(T) × 100

2

(A-a)(T) is the temperature-corrected alveolar-arterial oxygen tension

2

(a)(T) is the temperature-corrected oxygen tension of arterial

2

blood.

Arterial-Venous (a-v) Study

This section describes the parameters associated with an a-v study.

Arterial Oxygen Content

The oxygen content of arterial blood [ctO2(a)] is a determination of the total
oxygen carried by the arterial blood, including the oxygen bound to hemoglobin

and the oxygen dissolved in plasma and in the fluid within the red blood cells.

The system determines the oxygen content

19

recommendations

(a) = (OBF × tHb × FO2Hb) + (0.00314 × pO2)

ctO

2

where OBF is the O

as follows:

binding factor. The system uses the default value of 1.39, or

2

whatever value is entered as the default value in Setup. FO
format.

of arterial blood, based on CLSI

Hb is in decimal

2

Mixed Venous Oxygen Content

The oxygen content of mixed venous blood [ctO2( )] is a determination of the
total oxygen carried by the mixed venous (pulmonary artery) blood, including the

xygen bound to hemoglobin and the oxygen dissolved in plasma and in the fluid

o
within the red blood cells.

The system determines the oxygen content of mixed venous

19

recommendations

( ) = (OBF × ctHb × FO2Hb) + (0.00314 × pO2)

ctO

2

where OBF is the O

as follows:

binding factor. The system uses the default value of 1.39, or

2

whatever value is entered as the default value in Setup. FO
format.

blood, based on CLSI

Hb is in decimal

2

02087462 Rev. V

1-62 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Arterial-Venous Oxygen Content Difference

The arterial-venous oxygen content difference (ctO2(a- )) refers to the oxygen difference
between arterial and venous blood. It is a determina
to the tissues per volume of blood.

34

tion of the amount of oxygen released

When this result is obtained using a mixed venous sample, it is useful as an indicator of
changes in cardiac output and helps to assess the cardiac and metabolic factors affecting

arterial

oxygenation.

9

The system determines the arterial-venous oxygen content difference as follows:

(a- ) = ctO2(a)–ctO2( )

ctO

2

a-v Extraction Index

The a-v extraction index [ctO2([a- ]/a)] aids in the interpretation of the arterial-venous
oxygen content difference and can in
inadequate cardiac output to meet oxygen demands of the tissues.

properly determined using arterial blood and mixed venous blood.

dicate inadequate oxygen content in arterial blood or

9

The value is most

The system determines the a-v extracti

ctO

([a- ]/a) = [ctO2(a- ) / ctO2(a)] x 100

2

on index as follows:

Oxygen Consumption Rate

The oxygen consumption rate ( O2) is a determination of the volume of
oxygen consumed by the body per minute.

9

The system determines the oxygen consumption rate as follows:

O2 = ctO2(a- ) × Qt × 10

Oxygen Delivery

Oxygen delivery ( O2), which is also referred to as oxygen transport, refers to

34

the volume of oxygen per minute that is transported to the t

The system determines oxygen delivery as follows:

O2 = ctO2(a) × Qt × 10

issues.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-63

Physiologic Shunt

The physiologic shunt [ sp/ t(T)] is that portion of the cardiac output entering
the left side of the heart that does not perfect
calculation represents the best available means of delineating the extent to which

the pulmonary system contributes to hypoxemia.

The system determines the physiologic shunt using the following equation:

sp/ t = [(ctO2(c)–ctO2(a)) / (ctO2(a- ) + ctO2(c)–ctO2(a))] × 100

where

(c) = [OBF x tHb × (1–FCOHb–FMetHb)] + (0.00314 × A)

ctO

2

ly respire with the alveoli. The shunt

9

A = [(F

O = 10

pH

2

and the (

NOTE: If the F

OBF is the oxygen binding factor. The sys

/100) × (pAtm–pH2O)]–{pCO2(T) × [1.25–(0.25 × FIO2/100)]}

IO2

[(0.0244 x temp) + 0.7655]

+ 0.4

) in ctO2(a- ) is for a mixed venous sample.

value is not at least 40, the shunt cannot be calculated.

IO2

tem uses the default value of 1.39, or

whatever value is entered as the default value in Setup.

Estimated Shunt

Pulmonary artery blood gases are not always readily available, but a need to
determine changes in the physiologic shunt may still exist. The best alternative
method for reflecting changes in the physiologic shunt is the estimated shunt

sp/ t(est,T)] value, which is applicable to most hypoxemic patients with

[
cardiovascular stability.

The system determines the estimated shunt using the following equation:

sp/ t(est) = [(ctO2(c)–ctO2(a)) / ((ctO2(a- ), entered) + ctO2(c)–ctO2(a))] ×

100

9

where

(c) = [OBF × tHb × (1–FCOHb–FMetHb)] + (0.00314 × A)

ctO

2

A = [(F

pH

O = 10

2

For ctO
whatever value is entered as the default value

/100) × (pAtm–pH2O)]–{pCO2(T) × [1.25–(0.25 × FIO2/100)]}

IO2

[(0.0244 x temp) + 0.7655]

(a- ) entered, the system uses the default value of 3.5 mL/dL, or

2

+ 0.4

in Setup.

02087462 Rev. V

1-64 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

OBF is the oxygen binding factor. The system uses the default value of 1.39, or whatever
value is entered as the default value in Setup.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-65

References

1. Kirchhoff JR, Wheeler JF, Lunte CE, Heineman WR. Electrochemistry:

principles and measurements. In: Kaplan LA, Pesce AJ., editors. Clinical
Chemistry: theory, analysis, and correlation. 2nd ed. St. Louis: CV Mosby,
1989:213-227.

2. Siggaard-Andersen O. Electrochemistry. In: Tietz NW, editor. Fundamentals

of clinical chemistry. 3rd ed. Philadelphia: WB Saunders, 1987:87-101.

3. Siggaard-Anderson O, Durst RA, Maas AHJ. Physicochemical quantities and

units in clinical chemistry with special emphasis on activities and activity
coefficients. Pure Appl Chem 1984;56:567-594.

4. Clinical and Laboratory Standards Institute (formerly NCCLS).

Standardization of Sodium and Potassium Ion-Selective Electrode Systems to
the Flame Photometric Reference Method; Approved Standard; CLSI
Document C29-A; (Vol. 15, No. 1); Mar1995.

5. Sørensen, SPL. Enzymstudien. ii, Über die Messung und die Bedeutung der

Wasserstoffionenkonzentration bei enzymatischen Prozessen. Biochem Z
1909;12:131.

6. Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol

1997;108:247-253.

7. Levinsky NG. Acidosis and alkalosis. Ch 46 in Isselbacher KJ et al.

Harrison’s Principles of Internal Medicine, 13th Ed. New York:
McGraw-Hill, 1994:253-262.

8. Severinghaus JW, Bradley AF. Electrodes for blood pO

and pCO2

2

determination. J Appl Physiol 1968;13:515-520.

9. Shapiro BA, Harrison RA, Cane RD, Templin R. Clinical application of blood

gases. 4th ed. Chicago: Year Book Medical Publishers, 1989.

10. Moran R, Cormier A. The blood gases: pH, pO

, pCO2. Clin Chem News

2

1988;14(4/5):10-12.

11. Clark LC Jr. Monitor and control of blood and tissue oxygen tensions. Trans

Am Soc Artif Intern Organs 1956:2:41-56.

12. Levinsky NG. Fluids and electrolytes. Ch 45 in Isselbacher KJ et al.

Harrison’s Principles of Internal Medicine, 13th Ed. New York:
McGraw-Hill, 1994:242-253.

13. Tietz NW. Clinical Guide to Laboratory Tests, 3rd Ed. Philadelphia:

Saunders, 1995:124-127.

14. Mundy GR. Calcium homeostasis - the new horizons. In: Moran RF, editor.

Ionized calcium: its determination and clinical usefulness. Proceedings of an
international symposium. Galveston (TX): The Electrolyte Blood Gas
Division of the American Association for Clinical Chemistry, 1986:1-4.

02087462 Rev. V

1-66 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

15. Toffaletti JG. Calcium, magnesium, and phosphate. Ch 47 in Lewandrowski K.
Clinical Chemistry. Laboratory Management & Clinical Correlations. Philadelphia:
Lippincott Williams & Wilkins, 2002:710-724.

16. Ladenson JH. Clinical utility of ionized calcium. In: Moran RF, editor. Ionized
calcium: its determination and clinical usefulness. Proceedings of an international
symposium. Galveston (TX): The Electrolyte Blood Gas Division of the American
Association for Clinical Chemistry, 1986:5-11.

17. Emancipator K. Glucose and carbohydrates. Ch 38 in Lewandrowski K. Clinical
Chemistry. Laboratory Management & Clinical Correlations. Philadelphia:
Lippincott Williams & Wilkins, 2002:561-574.

18. Tietz NW. Clinical Guide to Laboratory Tests, 3rd Ed. Philadelphia: Saunders,
1995:268-273.

19. Clinical and Laboratory Standards Institute (formerly NCCLS). Blood Gas and pH
Analysis and Related Measurements; Approved Standard; CLSI Document C46-A;
(Vol. 21); 2001.

20. Benesch RE, Benesch R, Yung S. Equations for the spectrophotometric analysis of
hemoglobin mixtures. Anal Biochem 1973;55:245-248.

21. Miale JB. Laboratory medicine hematology. 6th ed. St. Louis: CV Mosby, 1982.

22. Clinical and Laboratory Standards Institute (formerly NCCLS). Clinical Laboratory
Waste Management; Approved Guideline; CLSI Document GP5-A; (Vol. 13, No. 22);
Dec 1993.

23. Spurzem JR, Bonekat HW, Shigeoka JW. Factitious methemoglobinemia caused by
hyperlipemia. Chest 1984;86(7):84-86.

24. Bunn HF. Anemia. Ch 56 in Isselbacher KJ et al. Harrison’s Principles of Internal
Medicine, 13th Ed. New York: McGraw-Hill, 1994:313-317.

25. Braunwald E. Hypoxia, polycythemia, and cyanosis. Ch 32 in Isselbacher KJ et al.
Harrison’s Principles of Internal Medicine, 13th Ed. New York: McGraw-Hill,
1994:178-183.

26. Morris MW, Davey FR. Basic examination of blood. Ch 24 in Henry JB. Clinical
Diagnosis and Management by Laboratory Methods, 19th Ed. Philadelphia: Saunders,
1996:549-593.

27. Cooper HA, Hoagland JC. Fetal hemoglobin. Mayo Clin Proc 1972;47(6):402-414.

28. Selby, Samuel M., editor. CRC standard mathematical tables. Cleveland (OH): The
Chemical Rubber Co., 1971.

29. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of
Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted
by Blood, Body Fluids and Tissue; Approved Guideline; CLSI Document M29-A;
(Vol 17, No. 20); Dec 1997.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-67

30. VanSlyke DD, Cullin GE. Studies of acidosis 1. The bicarbonate
concentration of blood plasma, its significance and its determination as a
measure of acidosis. J Biol Chem 1917; 30: 289-346.

31. Aberman A, Cavanille JM, Trotter J, Erbeck D, Weil MH, Shubin H. An
equation for the oxygen hemoglobin dissociation curve. J Appl Physiol 1973;
35(4): 570-571.

32. Kelman GR. Digital computer subroutine for the conversion of oxygen
tension into saturation. J Appl Physiol 1966;21:1375-1376.

33. Thomas LJ. Algorithms for selected blood acid-base and blood gas
calculations. J Appl Physiol 1972; 33:154-158.

34. Malley W. Clinical blood gases: application and noninvasive alternatives.
Philadelphia: WB Saunders, 1990.

35. Burritt MF, Cormier AD, Maas AH, Moran RF, O’Connell KM. Methodology
and clinical applications of ion-selective electrodes. Proceedings of an
international symposium. Danvers (MA): The Electrolyte/Blood Gas
Division of the American Association of Clinical Chemistry, 1987.

36. Martin L. Abbreviating the alveolar gas equation: an argument for simplicity.
Respir Care 1985;30(11):964-967.

37. Peris LV, Boix JH, Salom JV, Valentin V, et al. Clinical use of the arterial/
alveolar oxygen tension ratio. Crit Care Med 1983;11(11):888-891.

02087462 Rev. V

1-68 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

02087462 Rev. V

2 Operating the System

This section provides procedural information about operating the Rapidlab 1200
system.

Using Basic System Functions

This section contains information about the following system functions:

• starting up the system

• entering your password

• accessing system information

• accessing online help

• shutting down the system

Starting up the Rapidlab 1200 System

To start up the Rapidlab 1200 system, plug the power cord into an appropriate
power receptacle and turn on the power switch. If this is the first time the system
is being used, refer to
according to the needs of your facility, refer to System Configuration‚ page 8-1.

Replacing Supplies‚ page 2-2. To configure your system

Entering Your Password

Depending on the security options selected in Setup, the system may prompt you
to enter your password before performing some tasks. If prompted for your
password, perform the following steps:

NOTE: For systems connected to the Rapidlink or Rapidcomm system, your

password may expire if you exceed your certification date. You cannot access the
Rapidlab 1200 system until you renew your password.

1. At the interface screen, use the numeric buttons to enter your password.
If you have an alphanumeric password, select

alphanumeric keyboard.
To enter lower- or upper-case characters, select

toggles the keyboard between lower- and upper-case character sets.

NOTE: If your system includes the optional barcode scanner, you may use the

scanner to scan your password barcode. Contact your system supervisor for
assistance.

2. Select

Continue.

After you enter your password, your operator ID displays on screens where
you need to use an operator ID.

Keyboard to use the

LOCK. The LOCK button

02087462 Rev. V

2-2 Rapidlab 1200 Operator’s Guide: Operating the System

Replacing Supplies

Before you replace supplies, you can view a video of the following procedures:

• Emptying the waste bottle

•

Replacing the wash cartridge

• Replacing the reagent cartridge

• Replacing the AutomaticQC cartridge

Emptying the Waste Bottle

The system displays the Waste symbol on the banner when the waste bottle is 70% full.
This enables you to empty the bottle at a time when the system is not busy. If you must
replace the bottle before you can perform any other tasks, the system displays a message.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.

Refer to Appendix A, Protecting Yourself from Biohazards for
precautions when working with biohazardous materials.

recommended

1. Select

Status > Waste > Replace.

2. Follow the instructions in the video.

Replacing the Wash Cartridge

The system displays the Wash Cartridge symbol on the banner when less than 10% of the
volume remains or when less than 24 hours remain before the cartridge expires. This
enables you to replace the cartridge at a time when the system is not busy. If you must
replace the cartridge before you can perform any other tasks, the system automatically
displays a message.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.

Refer to Appendix A, Protecting Yourself from Biohazards for
precautions when working with biohazardous materials.

1. Select

Status > Wash Cartridge > Replace > Yes.

2. Follow the instructions in the video.

recommended

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: Operating the System 2-3

Replacing the Reagent Cartridge

The system displays the Reagent Cartridge symbol on the banner when less than
10% of the volume remains or when less than 24 hours remain before the cartridge
expires. This enables you to replace the reagent cartridge at a time when the
system is not busy. If you must replace the cartridge before you can perform any
other tasks, the system automatically displays a message.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.

Refer to Appendix A, Protecting Yourself from Biohazards for
precautions when working with biohazardous materials.

recommended

1. Select

CAUTION: Do not move the reagent cartridge valve or the sample port on the

Status > Reagent Cartridge > Replace > Yes.

replacement cartridge prior to installation. Moving the valve or the sample port
may invalidate the reagent cartridge.

2. Follow the instructions in the video.

Replacing the AutomaticQC Cartridge

The system displays the AutomaticQC cartridge symbol on the banner when 10 or
fewer samples remain for any level of QC material, or when less than 24 hours
remain before the cartridge expires. This enables you to replace the AutomaticQC
cartridge at a time when the system is not busy. If you must replace the cartridge
before you can perform any other tasks, the system automatically displays a
message.

When you are replacing the AutomaticQC Cartridge, clean the waste assembly.
Refer to Cleaning the Waste Assembly‚ page 5-27.

NOTE: If you install the new AutomaticQC cartridge incorrectly, the system

displays the Cartridge Reinstall screen. You can view the video again and reinstall
the cartridge correctly.

1. Select

Status > AutomaticQC Cartridge > Replace > Yes.

2. Follow the instructions in the video.

02087462 Rev. V

2-4 Rapidlab 1200 Operator’s Guide: Operating the System

Reinstalling the AutomaticQC Cartridge

If you have a problem the first time you install an AQC cartridge, or you remove an AQC
cartridge when in Diagnostics mode, you can reinstall it. You can also reinstall an AQC
cartridge after removing it to clean the waste housing.

NOTE: An AQC cartridge can be reinstalled more than once if it satisfies the AQC

cartridge reinstallation criteria.

AQC Cartridge Reinstallation Criteria

• The cartridge must display arrows on the back of the AQC cartridge interface
assembly. Cartridges without arrows cannot be reinstalled.

• The cartridge must be reinstalled on the system from which it was removed.

• The cartridge must be reinstalled within 6 hours of removal.

• The cartridge must have at least 1 sample left for all levels of AQC.

• The cartridge must have at least 1 day of use-life before expiration.

The system automatically evaluates the cartridge upon installation. If a cartridge fails to
meet the AQC cartridge reinstallation criteria, a message indicates that the AQC cartridge
is invalid. If this message displays you must install a new cartridge.

1. Examine the rear of the cartridge you removed to determine if there are arrows on the
back of the AQC cartridge interface assembly, as shown in Figure 2-1.

If there are no arrows, you cannot replace this AQC cartridge, but must use a new
cartridge.

Figure 2-1 Back of AQC Cartridge Interface Assembly Showing 2 Arrows Used
to Align Valve

02087462 Rev. V

The valve may not be correctly aligned after the cartridge is ejected.

Rapidlab 1200 Operator’s Guide: Operating the System 2-5

To check, go to step 2.

Figure 2-2 Valve Aligned so Top of the Valve is Between 2 Arrows

2. Verify the valve is correctly aligned as shown in Figure 2-2, with the top of
the valve between the 2 arrows.

If the valve is not correctly aligned, manually move the valve so the top of the
valve is aligned between the two arrows.

3. Select the Status screen.
Enter your password if necessary.

4. Select the AutomaticQC icon

5. Select Replace > Yes.

6. Follow the instructions in the video to reinstall the cartridge.

Accessing System Information

You may need to access system information for assistance or when ordering
supplies. To access system information, select

Status > System Information.

Accessing Online Help

The system has online Help that provides troubleshooting and maintenance
procedures, and general information about using the system. Select the help
button, which appears as a question mark in the banner section of the main
screens.

The system initiates some online help automatically when you select certain
functions.

02087462 Rev. V

2-6 Rapidlab 1200 Operator’s Guide: Operating the System

Shutting Down the System

Use this procedure to remove power from the system for 24 hours or less.

CAUTION: Do not remove power from the system for more than 6 hours if

cartridges are installed. Cartridges installed in the system remain stable for 6
hours without power.

CAUTION: To prevent damage to the hard drive and permanent loss of data, use

this procedure to shut down the system.

1. Select

Status > Shutdown > Yes.

2. When prompted, turn the power switch off.
The power switch is on the back panel of the system.

WARNING: Do not operate the system in the presence of flammable anesthetic

mixture with air, O

, or nitrous oxide. The risk of explosion exists in a potentially

2

explosive environment. Refer to Protecting Yourself from Electrical Hazards‚
page A-3 for recommended precautions when working around electricity.

3. To restore power to the system, turn the power switch on.

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: Operating the System 2-7

Collecting Patient Samples

This section describes sample requirements, collection procedures, and handling
techniques for pH and blood gas. The sample collection and handling guidelines

described here are also suitable for CO-ox analysis.

1

Collecting Samples

Collect blood samples under proper medical supervision when selecting a site and
performing the collection procedure. Use sterile technique at all times to avoid
infecting the sample site.

Immediately expel any bubbles that occurre

d during the sample collection. Cap
the sample device immediately after you collect the sample to avoid room air
contamination. When you collect samples with a capillary tube, fill the capillary
tube completely, cap it securely, and mix the sample thoroughly.

CAUTION: Never use mineral oil or mercury in syringes because these substances

may alter sample values and damage the system.

Collect blood in heparinized syringes that

satisfy requirements for blood gas

analysis. Use capillary tubes that contain the appropriate balanced heparin.

NOTE: To prevent hemolysis and maintain sample integrity, use capillary tubes

that do not contain mixing beads.

Using Anticoagulants

For human whole blood samples, use sample devices containing only
calcium-titrated (balanced) heparin or lithium heparin as the anticoagulant.

NOTE: Other anticoagulants, such as EDTA, citrate, oxalate, and fluoride

significantly affect blood pH, sodium, potassium, chloride, ionized calcium
results, and CO-ox results. For more information about substances that interfere
with analyte measurement, refer to Performance Characteristics‚ page E-11.

If you are analyzing samples for ionized calciu

m, you can use a maximum of 15
units of lithium heparin for each 1.0 mL of sample. If you are not analyzing
samp

les for ionized calcium, you can use up to 50 units of lithium heparin for

each 1.0 mL of sample.

1 For more information about collecting and handling patient samples, refer to Clinical and Laboratory Standards

Institute. Blood Gas and pH analysis and Related Measurements: Approved Guideline; CLSI Document C46-A;
(Vol. 21, No. 14); 2001.

02087462 Rev. V

2-8 Rapidlab 1200 Operator’s Guide: Operating the System

Using Different Sample Sources

The Rapidlab 1200 systems can analyze samples obtained from the following sources:

Sample Source Description

Arterial blood Arterial blood is commonly recommended for use in blood gas

studies because it accurately reflects acid-base physiology and
oxygenation status.
Arterial blood is routinely obtained from the radial, femoral, or
brachial arteries. Other sites can be used following
catheterization or surgical procedures.

Venous blood Venous blood can provide satisfactory pH and pCO

however, venous pO

values may not be significant in routine

2

values;

2

clinical studies without simultaneous study of arterial pO
Venous blood is routinely obtained from an antecubital vein

using vacuum tube collection systems. Other sites can be used as
necessary. Venous oxygen saturation values reported must be so
labeled to ensure correct interpretation of the results.

Mixed venous
blood

Mixed venous (pulmonary artery) blood may be obtained from a
pulmonary artery catheter after carefully clearing the catheter of
infusion fluid. Take appropriate precautions to prevent mixing of
pulmonary capillary blood with the pulmonary artery blood.

Capillary blood Capillary blood, when carefully collected under the proper

conditions, resembles arterial blood and can be used for blood
gas studies if the sample limitations are understood.

*

Only small

quantities of blood are required for capillary blood analysis.
Capillary blood can be obtained from the heel, finger, or earlobe.

The area chosen should be prewarmed or stimulated before the
puncture to promote arterial circulation. The puncture should be
deep enough to ensure that blood flow is free and rapid. Take
appropriate precautions to minimize hemolysis, because
potassium levels are falsely elevated in hemolyzed blood.

* Clinical and Laboratory Standards Institute. Blood Gas and pH Analysis and Related

Measurements: Approved Guideline; CLSI Document C46-A; (Vol. 21, No. 14); 2001.

.

2

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: Operating the System 2-9

Handling and Storing Samples

The following condition can cause erroneous results even when samples are
collected correctly:

• Metabolic activity in the sample that occurs between sampling and

completion of analyses

• Contamination of the sample by room air

• Incorrect mixing of the sample before analysis

To minimize the errors these conditions can cause, use correct storage and
handling techniques. You can minimize errors caused by metabolic changes by
analyzing samples as soon as possible after collection. This is particularly
important for pO

oxygen and glucose, and lactate is rapidly formed during storage. Lactate is
produced by glycolysis and increases while the sample is stored. Glycolysis is
temperature dependent. Lactate increases approximately 0.1

1.0 mM/hour at 37°C.
factors:

• Storage temperature

, glucose, and lactate values, because the sample consumes

2

mM/hour at 4°C and

1

The rate of oxygen consumption depends on several

• White blood cell count

• Reticulocyte count

Observe the following sample-handling and storage steps when you obtain human
whole blood samples:

2

• Analyze the sample as soon as possible to minimize oxygen consumption.

• Blood collected for special studies, such as A-a O

gradients, or shunt studies,

2

should be analyzed within 5 minutes of collection.

• Plastic syringes should not be iced, but kept at room temperature as long as

the blood is analyzed within 30 minutes of collection.

• Oxygen and carbon diaoxide levels in blood kept at room temperature for

30 minutes or less are minimally affected except in the presence of an
elevated leukocyte or platelet count.

• If a prolonged time delay of more than 30 minutes before analysis is

anticipated, the use of glass syringes and storage in ice water are
recommended.

Syringes stored in ice water should not be used for electrolyte determinations
as room temperature effects on diffusion in and out of the red blood cells can
cause unreliable potassium results. Store in ice water is applicable to blood
gas measurements.

1 Wandrup, Clinical Chemistry, 35/8, 1741, (1989)
2 Blood Gas and pH analysis and Related Measurements: Approved Guideline; CLSI Document C46-A;

(Vol. 21, No. 14); 2001.

02087462 Rev. V

2-10 Rapidlab 1200 Operator’s Guide: Operating the System

You can store a sample collected in a glass syringe in the ice slurry for up to 2 hours
without significant change in values for pH and pCO

, however, this affects the K+

2

and lactate values. Samples with elevated white blood cell or reticulocyte counts
deteriorate more rapidly, and you should analyze them immediately.

• Before you analyze the sample, roll the syringe or the capillary tube between your
palms and gently invert it several times to mix the sample thoroughly.

Blood cells settle during storage, and if you do not mix the sample well before
analysis, the total hemoglobin results obtained can be falsely decreased or increased.
Mix all samples using a consistent technique.

• If the sample is chilled or has been stored for more than 10 minutes, increase the
mixing time to ensure that the sample is thoroughly mixed.

• Position any labels toward the back of the syringe barrel near the plunger so the label
does not block your ability to insert the syringe into the system or cause it to fall off
after it is inserted.

• Dispose of used sample devices according to your institution’s infection control
policy.

Understanding System Limitations

The following procedural limitations apply to Rapidlab 1260 and 1265 systems:

• Avoid hemolyzed samples because they falsely elevate potassium levels due to
intra-erythrocyte potassium levels.

• Avoid samples with elevated levels of salicylates, salicylate derivatives such as
ibuprofen, and bromide (Br¯), because they falsely elevate chloride levels.

• Avoid samples contaminated with perchlorate (ClO
(I¯), and nitrate (NO

¯), because they falsely elevate chloride levels.

3

• Avoid using excessive levels of heparin anticoagulants.
Excessive levels of heparin anticoagulants cause calcium-heparin chelation and

falsely decrease calcium levels.

• Avoid using sample collection devices containing fluoride/oxalate anticoagulants
(gray-top tubes).

These anticoagulants have a significant effect on glucose and lactate.

¯), thiocyanate (SCN¯), iodide

4

02087462 Rev. V

Rapidlab 1200 Operator’s Guide: Operating the System 2-11

Analyzing Samples

This section contains information about analyzing the following samples:

• Syringe samples

•

Capillary samples

• Microsamples

• pH and pH, Glu, and Lac samples

•tHb samples

Analyzing Syringe Samples

Use this procedure to analyze patient blood samples using a syringe.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.

Refer to Appendix A, Protecting Yourself from Biohazards for
precautions when working with biohazardous materials.

recommended

1. Observe all rules and guidelines in Collect

NOTE: If you have a priority sample, but a message is displayed indicating

that the system is busy, select

Cancel to interrupt the system. If Cancel is not

ing Patient Samples‚ page 2-7.

available, wait until the message is not displayed to analyze the patient
sample.

2. At the Analysis screen, select the patient sample type (arterial, venous, mixed
venous).

The default type is a syringe of arterial blood.

3. Scan the barcode for the patient sample, if required.

4. Insert the syringe into the sample port.

5. Select

Analyze.

02087462 Rev. V

2-12 Rapidlab 1200 Operator’s Guide: Operating the System

If the system determines that insufficient sample is present or bubbles are in the
sample, you are prompted to position the sample like a microsample. For information
about microsample analysis, refer to Analyzing Microsamples‚ page 2-14.

CAUTION: Do not leave the sample device in the sample port after the system

prompts you to remove it. The system performs a wash after each sample analysis.
Leaving the sample device in place while the system performs a wash could
contaminate that wash with blood and adversely affect the next sample or system
operation.

6. When prompted, remove the sample device and select

7. If prompted, enter demographic information and select

Continue.

Continue.

You can scan the patient ID and accession number in the appropriate field. For more
information about entering data, refer to Entering Patient Sample Data‚ page 2-22.

8. View the results.
For information about how results are displayed on the screen and printed reports,

refer to Viewing Patient Results‚ page 2-27.

9. Select

CAUTION: If the wash that is performed after sample analysis does not

Continue when you finish viewing the results.

completely clean the fluid path, you should perform an additional wash. To
determine if the path is clean, observe if any colored fluid remains in the fluid
path after analysis. To perform a wash at the Analysis screen, select Wash.

The Wash button is grayed out if the system is busy. The Wash button is not
available if the lamp failure or LIS communications error indicators, which
occupy the same space on the screen, are active.

Analyzing Capillary Samples

02087462 Rev. V

Use this procedure to analyze patient blood samples using a capillary tube.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.

Refer to Appendix A, Protecting Yourself from Biohazards for

recommended

precautions when working with biohazardous materials.

NOTE: Always fill the capillary tube completely. Be sure to use the recommended

volume for the sampling mode and system model. For more information about Fill
Volumes, refer to Recommended Fill Volumes‚ page C-1.

1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.