You are on page 1of 448

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 diagnostic use.

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


Multicap are trademarks of Siemens Healthcare Diagnostics.

Windows is a trademark of Microsoft Corporation.

IBM is a trademark of International Business Machines Corporation.

Origin: UK

The information in this operator’s guide was correct at the time of printing. However, Siemens continues to
improve products and reserves the right to change specifications, equipment, and maintenance procedures at
any time without notice.

If the system is used in a manner differently than specified by Siemens, the protection provided by the
equipment may be impaired. See warning and hazard statements.
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, Section 1:
learn about the hardware, System Features
learn about user interface components, Hardware Overview,
learn about principles of potentiometry, Software Overview,
Technology.
process samples, monitor status, or manage sample Section 2:
results, Operating the System.
calibrate the system, Section 3:
Calibration.
learn about QC options, Section 4:
analyze QC samples, Quality Control.
perform scheduled maintenance activities, Section 5:
record maintenance activities, Maintenance.
investigate and correct system problems, Section 6: Troubleshooting.
manage data files, Section 7:
Data Management.
modify test definition parameters, Section 8:
modify system parameters, System Configuration.
set up LIS parameters,
learn about biohazard precautions, Appendix A:
learn about laser precautions, 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, Appendix B:
find contact information, Warranty and Support
Information.
learn about fill volume and stability information about Appendix C:
system fluids, System Fluids.
find information about ordering supplies, Appendix D:
Ordering Supplies.
learn about system specifications, Appendix E:
System Specifications.
learn about system symbols, Appendix F:
Symbols.
learn about system terms, Appendix G:
Glossary.

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

Convention Description
BIOHAZARD: Biohazard statements alert you to potentially
biohazardous conditions.

LASER WARNING: Laser Warning statements alert you to the risk of


exposure to lasers.

WARNING: Warning statements alert you to conditions that


may cause personal injury.

CAUTION: 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.
NOTE: Note statements alert you to important information
that requires your attention.
Bold Bold type indicates commands on the user
interface, keys, or the exact text that an operator
needs to type.
For example, if the word save is displayed as Save,
it refers to the selecting the Save button on the 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.

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


Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-i
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii
Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iii

1 System Overview and Intended Use


Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
User Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
AutomaticQC Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
AutomaticQC Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Waste Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Reagent Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Reagent Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
Wash Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
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 (pO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38
Electrolytes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Concentration of Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
Concentration of Potassium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
Concentration of Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43
Concentration of Ionized Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . 1-44
Metabolites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45
Concentration of Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45
Concentration of Lactate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-46
Glucose and Lactate Biosensors . . . . . . . . . . . . . . . . . . . . . . . . . . 1-46
Hemoglobin and its Derivatives . . . . . . . . . . . . . . . . . . . . . . . . 1-48
Total Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
Oxyhemoglobin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
Deoxyhemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49
Methemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50
Carboxyhemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50
Sulfhemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50
Determination of Hemoglobin Derivatives . . . . . . . . . . . . . . . . . . . 1-51
CO-oximeter Measurement Technology . . . . . . . . . . . . . . . . . . 1-51
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-52
Bicarbonate Ion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54
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
pO2/FIO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59
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

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
Accessing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Printing or Sending Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Result Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Recalling QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

02087462 Rev. V
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+ K+ Ca++ Cl¯ . . . . . . . . . . . . . . . . . . . . . . . 6-49
D2 Excessive Drift: Glu Lac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50
D2 Excessive Drift: tHb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50
D3 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51
D3 Slope Error: pO2 pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51
D3 Slope Error: pH Na+ K+ Ca++ Cl¯ Ref . . . . . . . . . . . . . . . . . . . 6-51
D3 Slope Error: Glu Lac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-52
D3 Slope Error: tHb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-52
D4 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53
D4 Offset Error: pO2 pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53
D4 Offset Error: pH Na+ K+ Ca++ Cl¯ . . . . . . . . . . . . . . . . . . . . . . 6-53
D4 Offset Error: Glu Lac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54
D5 Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54
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¯. . . . . . . . . . . . . . . . . . . 6-57

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
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

02087462 Rev. V
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® or Rapidcomm® System . . . . . . . . . . .8-27
Connecting to a CompleNet® Network Connection . . . . . . . . . . . . .8-28
Entering IP Addresses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-29
Using DHCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-30
Selecting sO2 as a Measured or Calculated Value
for LIS Transmission (LIS only) . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-30
Connecting to a Laboratory Information System . . . . . . . . . . . 8-30
Setting up Auto Send Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-32
Setting Up Remote Viewing (Rapidcomm Only) . . . . . . . . . . . . . . .8-32
Setting up Secured Options . . . . . . . . . . . . . . . . . . . . . . 8-35
Setting up System Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-35
Setting up Operator Security Levels . . . . . . . . . . . . . . . . . . . . . 8-35
Defining Operator IDs and Passwords . . . . . . . . . . . . . . . . . . . . . .8-37

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, FO2Hb, FCOHb,
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
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, pCO2, pO2
1245 pH, pCO2, pO2, tHb, FO2Hb, FCOHb, FMetHb, FHHb
1260 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate
1265 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb,
FCOHb, FMetHb, FHHb

Features
The Rapidlab 1200 systems have the following features:
• Compact design
• Self-contained reagent and wash cartridges that you can replace easily
• Automatic calibrations of the sensors
• Automatic sample aspiration that eliminates variability in sampling technique
• Automatic sampling for QC at customized intervals using the optional
AutomaticQC® cartridge
• High resolution touchscreen that tilts for viewing information and 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 Setting up
AutomaticQC Schedule‚ page 8-5.

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 1200.
Level Volume Contents
1 75 mL Buffered bicarbonate solution with Na+, K+, Ca++, Cl-, carbon
dioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and
preservative.
2 115 mL Buffered bicarbonate solution with Na+, K+, Ca++, Cl-, carbon
dioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and
preservative.
3 155 mL Buffered bicarbonate solution with Na+, K+, Ca++, Cl-, carbon
dioxide, oxygen, nitrogen, dye, glucose, lactate, surfactant, and
preservative.

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

Figure 1-6 AutomaticQC Manifold

02087462 Rev. V
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 Ingredients
Slope 160 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali
halides), organic buffers, catalyst, and surfactant
200 460 mL gases (oxygen, carbon dioxide, nitrogen), salts (alkali
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
pCO2 35 mmHg 70 mmHg
pO2 154 mmHg 0 mmHg*
Na+ 116 mmol/L 159 mmol/L

K+ 4.0 mmol/L 8.0 mmol/L

Ca++ 1.25 mmol/L 0.62 mmol/L

Cl- 98 mmol/L 69 mmol/L


Glu 180 mg/dL 0 mg/dL
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 pO2 Oxygen 7 K+ Potassium


2 pCO2 Carbon dioxide 8 Ca ++ Calcium
3 Gnd Sample ground/temperature 9 Cl - Chloride
4 Glu Glucose 10 Na+ Sodium
5 Lac Lactate 11 Ref Reference
6 pH pH

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

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.

02087462 Rev. V
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

AutomaticQC cartridge 10 or fewer tests for Less than 24


any level of QC
material

02087462 Rev. V
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 Less than 72


volume

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 1200 systems sensors have the following
characteristics:
Molecular or ion-specific a membrane that is selective for a specific ion
recognition mechanism
Transducer mechanism converts the potential generated by the recognition
mechanism to an electrical signal using
potentiometry or amperometry
Signal processor system conditions the electronic signal from the sensor; the
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.
Ecell = Emeas - (Eref + Elj)

where
Ecell = electrochemical cell potential

Emeas = measuring electrode half-cell potential

Eref = reference electrode half-cell potential

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.
Ecell = (Eref elmt + Ememb) - (Eref + Elj)

where
Ecell = electrochemical cell potential

Eref elmt = potential of the ISE inner reference element

Ememb = potential of the ISE membrane

Eref = reference electrode half-cell potential

Elj = liquid junction potential

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.1
Ecell = K + (2.3 RT/ZF) log ai

where
Ecell = electrochemical cell potential

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 * z2
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.3
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+ 1260, 1265

K+ 1260, 1265

Cl- 1260, 1265

Ca++ 1260, 1265

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

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 electrodes, 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, hydrogen 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:

pH = − log10 cH +

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

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:

base
pH = pK + log
acid

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:

base
pHα
acid

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 means of determining acid-base disturbances. Acid-base
disorders can result in several pathologic conditions. Acidosis (low pH) stems from either
respiratory failure (high pCO2) or from metabolic causes (including ketoacidosis, lactic
acidosis, uremia, severe diarrhea, hypoaldosteronism, renal tubular disease, drug effects,
or poisoning from several specific agents). Alkalosis (high pH) stems from
hyperventilation (low pCO2) or from metabolic causes (including excessive vomiting,
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

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. CO2 is transported through the blood as bicarbonate (HCO3–),
dissolved CO2, and carbonic acid (H2CO3). CO2 exists in a dynamic state in the
blood as seen in the following equation:

CO2 + H 2O ↔ H 2CO3 ↔ HCO3− + H +

02087462 Rev. V
1-36 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

The levels of HCO3–, H2CO3, and dissolved CO2 play a major role in maintaining the pH
in blood. This relationship is best described through the Henderson-Hasselbalch equation:

base
pH = pK + log
acid

Substituting HCO3– as the base and dissolved CO2 and H2CO3 as the acid, the equation
reads as follows:

HCO 3−
pH = pK + log
CO 2 + H 2 CO 3

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

HCO 3−
pHα
H 2 CO3

Although other acids and bases are present in the blood, the H2CO3/HCO3– relationship is
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 HCO3– and ctCO2. Because the pCO2
value is proportional to the content of dissolved CO2/HCO3– , the value for pCO2 can be
used along with pH not only to calculate HCO3– but also to aid in the differentiation of
acid-base abnormalities.
This analyte reflects the overall respiratory status. Thus high pCO2 indicates respiratory
suppression or failure, whereas low pCO2 indicates hyperventilation (which in turn may
stem from hypoxia, anxiety, fever, cerebral disease, cirrhosis, or excessive mechanical
ventilation). Extreme abnormalities of pCO2 reflect a potentially life-threatening
pathophysiologic state that must be corrected promptly.6,7
Together, pH and pCO2 provide a more definitive diagnostic tool in assessing respiratory
function. An increase in the pCO2 value and a decrease in pH indicates respiratory
acidosis, a condition in which CO2 is retained by the lungs. A decrease in the pCO2 value
and an increase in pH indicates respiratory alkalosis, a condition in which the lungs are
expiring too much CO2 relative to the amount produced.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-37

pCO2 Sensor

The pCO2 sensor is based upon the electrode described by Severinghaus and
Bradley.8 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 CO2 separates this solution from the sample. The
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:

CO2 + H 2 O ↔ HCO3− + H +

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 CO2.

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 O2 from the lungs with hemoglobin in red blood cells, transportation of the
O2 through the arteries to the cell, and finally the release into the tissues and utilization of
O2 at the cellular level.

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
pO2(A), which indicates the oxygen tension in arterial blood, reflects the pressure or
driving force for moving oxygen from 1 location to the next due to pressure differential; it
is not a measurement of the O2 content, but it provides a measurement tool to evaluate the
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.9
This analyte reflects the ability of the lungs to deliver oxygen to the blood. Hypoxia (low
pO2) may occur despite adequate respiration due to parenchymal lung diseases
(pneumonia, asthma, pulmonary edema, and pulmonary fibrosis) due to pulmonary
shunting of blood. Extremely low pO2 is a potentially life-threatening pathophysiologic
state that must be corrected promptly.6,7
The measurement of pO2 is significant in evaluating the degree of hypoxemia (a
deficiency of O2 in arterial blood) present in a patient. The laboratory reference value for
pO2 is usually 95 mmHg (12.7 kPa) for a healthy young adult living near sea level.
However, as with pCO2 and pH, a wider range of values may occur before any therapeutic
action is indicated. Generally a pO2 of 80 mmHg (10.7 kPa) signals therapeutically
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 pO2 values of about
1 mmHg (0.13 kPa) per year.10

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-39

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:

O2 + 2 H 2O + 4e − → 4OH −

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

4 Ag → Ag + + 4e −

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
state that must be corrected promptly.6,12

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.7,13

Chloride Sensor

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++ is essential for the contractility of
smooth vascular muscle and plays a vital part in cardiovascular function. Ca++ is also
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.14

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++ may cause neuromuscular
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.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 mg/dL, which exceeds the span of the
normal range. Its effects, if not taken into account, are clearly significant.16

Calcium Sensor

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, IGF2-secreting tumor, factitious hypoglycemia, postprandial syndrome,
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 CO2 and H2O.

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

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.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-47

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:

GOX
C6 H12O6 + H 2O + O2 → C6 H12O7 + H 2O2
( glucose) ( gluconic acid )

where GOX is the glucose oxidase.


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

02087462 Rev. V
1-48 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

H 2O2 → 2 H + + O2 + 2e −

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:

LOD
C3 H 6O3 + H 2O + O2 → C3 H 4O3 + H 2O2
( lactic acid ) ( pyruvic acid )

where LOD is the lactate oxidase.


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

H 2O2 → 2 H + + O2 + 2e −

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,
pCO2, pO2, 2, 3-diphosphoglycerate concentration, and temperature.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.21

02087462 Rev. V
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 the following
equation:
tHb = FO2Hb + FHHb + FMetHb + FCOHb

In anemia, hemoglobin is low. Numerous specific 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

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:
FO2Hb = cO2Hb / ctHb x 100

Deoxyhemoglobin
Deoxyhemoglobin (HHb) refers to the hemoglobin capable of binding oxygen.
Deoxyhemoglobin is sometimes referred to as reduced hemoglobin.21 The
deoxyhemoglobin reference range for arterial blood for a normal population is 0.0
to 5.0%.

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 = cHHb / ctHb x 100
This is the fraction of hemoglobin that could deliver more oxygen to body tissues if
pulmonary oxygenation were improved.26

Methemoglobin
This is a fraction of hemoglobin that cannot deliver oxygen to body tissues and is elevated
in certain metabolic diseases.26 Methemoglobin (MetHb), which is sometimes known as
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.19,27 Infants
and other individuals with significant fetal hemoglobin concentrations show increased
susceptibility to methemoglobinemia because fetal hemoglobin converts to
methemoglobin more readily than adult hemoglobin.21 The methemoglobin reference
range for arterial or venous blood for a normal population is 0.0 to 1.5%.
The percent of methemoglobin is determined using the following equation:
FMetHb = cMetHb / ctHb x 100

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

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
infections.26 Sulfhemoglobin has an extremely low affinity for oxygen and may
often be accompanied by methemoglobinemia. The presence of sulfhemoglobin
affects oxyhemoglobin values and other quantities if its absorbance spectrum is
not accounted for.19 The sulfhemoglobin reference range for a normal population
is 0.0 to 2.2%.
The CO-oximeter (CO-ox) module detects and indicates 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 matrix equations.
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:
Ax = ε1C1 + ε2C2 +... εnCn

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


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 VanAssendelft28, 29 and Benesch,


Benesch, and Yung.29

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 pCO2 partial pressure of carbon dioxide
pO2 partial pressure of oxygen

pH or H+ hydrogen ion concentration (expressed as pH or


H+)
Electrolyte* Na+ sodium

K+ potassium

Ca++ calcium ion concentration

Cl- chloride

Ca++ (7.4) calcium adjusted for pH


AnGap estimated difference of unmeasured cations and
unmeasured anions
Metabolic HCO3¯act actual bicarbonate
HCO3¯std standard bicarbonate
BE(B) base excess of blood
BE(ecf) base excess of extracellular fluid

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-53

Parameters Results Description


ctCO2 total carbon dioxide
Oxygenation O2SAT(est) oxygen saturation (estimated)
O2CT(est) oxygen content (estimated)

Hct† hematocrit calculated from tHb


pO2/FIO2 arterial pO2 to fraction of inspired O2 ratio

Metabolites* Glu glucose


Lac lactate
Temperature pH(T), H+(T) temperature corrected pH
Corrected
pCO2(T) partial pressure of carbon dioxide
pO2(T) partial pressure of oxygen
RI(T) respiratory index
pO2(A-a)(T) alveolar-arterial oxygen tension diff
pO2(a/A)(T) alveolar-arterial oxygen tension ratio

Qsp/Qt(T)† physiologic shunt

Qsp/Qt(T)(est)† estimated physiologic shunt


a-v Study ctO2(a) arterial oxygen content
Parameters†
ctO2(v) venous oxygen content
ctO2( ) mixed venous oxygen content
ctO2(Hb) oxygen content of hemoglobin

O2 oxygen consumption rate

O2 oxygen delivery

ctO2([a- ]/a) a-v extraction index


ctO2(a- ) arterial-mixed venous oxygen content
difference
CO-oximetry tHb total hemoglobin
Parameters†
FO2Hb oxyhemoglobin
FCOHb carboxyhemoglobin
FMetHb methemoglobin
FHHb deoxyhemoglobin
sO2 hemoglobin oxygen saturation

02087462 Rev. V
1-54 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

Parameters Results Description


BO2 oxygen binding capacity
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.

Bicarbonate Ion
The majority of CO2 is transported through the body as the bicarbonate ion (HCO3–),
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 (HCO3–act), which is determined directly from the pH and pCO2
values, based on the recommendations from the Clinical and Laboratory Standards
Institute (CLSI) as follows:
HCO3–act = 0.0307 × pCO2 × 10(pH(37)–6.105)

• Standard bicarbonate (HCO3–std), which is a determination of the plasma HCO3–


concentration if the blood is equilibrated to a pCO2 of 40 mmHg9 using the equation
described by VanSlyke and Cullin30:

HCO3 − std = 24.5 + 0.9 × A +


[[( A − 2.9) ](2.65 + 0.31× tHB )]
2

1000

where

0.2 × tHB × (100 − O2 SAT (est ))


A = BE (B ) −
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.9

02087462 Rev. V
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) = HCO3–act–24.8 + (16.2 × (pH(37)–7.40))
• Base excess of blood (BE(B)), formerly known as in vitro base excess,
determined as follows:
BE(B) = (1–0.014 × tHb) × [(HCO3–act–24.8) + ((7.7 + 1.43 × tHb) ×
(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 pCO2, total carbon dioxide is
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) + HCO3–act

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

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
temperature value, which enables the system to provide temperature-corrected results for
pH, pCO2, and pO2.

The system determines temperature-corrected results using the following correction


factors:19
pH correction = ΔpH / ΔT = –0.0147 + 0.0065(7.4–pH)

Δ log pCO2
pCO2 correction = = 0.019
ΔT

Δ log pCO2 5.49 × 10 –11 × pO2 3.88 + 0.071


pCO2 correction = =
ΔT 9.72 × 10 – 9 × pO2 3.88 + 2.30

Hemoglobin Oxygen Saturation


Hemoglobin oxygen saturation (sO2) is a ratio of the amount of hemoglobin bound to
oxygen to the total amount of hemoglobin able to bind oxygen.19 Hemoglobin 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:
sO2 = (100 x FO2Hb) / (FO2Hb + FHHb)

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 situations. However, at very low
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 following
relationship:
ctO2 = (FO2Hb ×1.39 × ctHb + 0.00314 × pO2)

where ctHb is expressed in g/dL and FO2Hb is decimal.19

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Overview and Intended Use 1-57

If FO2Hb is unavailable, oxygen content is derived from estimated oxygen


saturation [O2SAT(est)] according to the following equation:

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 (Qsp/Qt), or by assuming that the value obtained [O2SAT(est)] is
equivalent to fractional oxyhemoglobin.19

Oxygen Content of Hemoglobin


The oxygen content of hemoglobin, ctO2(Hb), is the volume of oxygen actually
bound to hemoglobin.19 The oxygen content of hemoglobin, with 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.
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. FO2Hb is in decimal
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
be bound to the available hemoglobin.19 The oxygen capacity of 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. FO2Hb + FHHb are in
decimal format.

02087462 Rev. V
1-58 Rapidlab 1200 Operator’s Guide: System Overview and Intended Use

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
position of the oxygen-hemoglobin dissociation curve:21
• 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 p50 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, pCO2, and temperature.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

pO2c = pO2 × 10–[0.48 x (7.4–pH(37)) + 0.0013BE(B)]

and pO2s is calculated with an interactive program.31

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
the effectiveness of oxygen therapy.

The system estimates oxygen saturation using the relationship described by Kelman32 and
Thomas33 as follows:

N 4 − 15 N 3 + 2045N 2 + 2000 N
O2 SAT (est ) = *100
N 4 − 15 N 3 + 24000N 2 − 31100N + 2.4 × 106

where

N = pO2 × 10 [0.48(pH(37)–7.4)–0.0013 BE(B)]

02087462 Rev. V
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/FIO2
The pO2/FIO2 ratio is an index of the efficiency of pulmonary oxygen exchange
that relates the arterial pO2 to the fraction of inspired oxygen.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:35

Ca++ (7.4) = Ca++ × 10[–0.178 × (7.40–pH(37))]


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- + HCO3–act)

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 sp/ t shunt fraction, which is based on measurements of
pO2 and oxygen content.

The gas exchange indices are provided with 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-aDO2, is useful as an index of gas exchange within the lungs if the ctO2
measurements are not available. The following equation36 is used:
pO2(A-a)(T) = pO2(A)(T)–pO2(a)(T)

where pO2(A)(T) is the temperature corrected oxygen tension of alveolar gas and
pO2(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 FIO2 changes.
This ratio is useful in predicting oxygen tension in alveolar gas. The following equation is
used:37
pO2(a/A)(T) = pO2(a)(T) / pO2(A)(T) × 100

where pO2(a)(T) is the temperature corrected oxygen tension of arterial blood and
pO2(A)(T) is the temperature corrected oxygen tension of alveolar gas.

02087462 Rev. V
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 pO2, when both values are corrected
for patient temperature. This index is also a means of assessing the degree of
pulmonary shunting.19
The system determines respiratory index as follows:
RI(T) = pO2(A-a)(T) / pO2(a)(T) × 100

where pO2(A-a)(T) is the temperature-corrected alveolar-arterial oxygen tension


difference and pO2(a)(T) is the temperature-corrected oxygen tension of arterial
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 of arterial blood, based on CLSI
recommendations19 as follows:
ctO2(a) = (OBF × tHb × FO2Hb) + (0.00314 × pO2)

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. FO2Hb is in decimal
format.

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
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 of mixed venous blood, based on CLSI
recommendations19 as follows:
ctO2( ) = (OBF × ctHb × FO2Hb) + (0.00314 × pO2)

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. FO2Hb is in decimal
format.

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 determination of the amount of oxygen released
to the tissues per volume of blood.34
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:
ctO2(a- ) = ctO2(a)–ctO2( )

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 indicate inadequate oxygen content in arterial blood or
inadequate cardiac output to meet oxygen demands of the tissues.9 The value is most
properly determined using arterial blood and mixed venous blood.
The system determines the a-v extraction index as follows:
ctO2([a- ]/a) = [ctO2(a- ) / ctO2(a)] x 100

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


the volume of oxygen per minute that is transported to the tissues.34
The system determines oxygen delivery as follows:

O2 = ctO2(a) × Qt × 10

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 perfectly respire with the alveoli. The shunt
calculation represents the best available means of delineating the extent to which
the pulmonary system contributes to hypoxemia.9
The system determines the physiologic shunt using the following equation:

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

where
ctO2(c) = [OBF x tHb × (1–FCOHb–FMetHb)] + (0.00314 × A)

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

pH2O = 10[(0.0244 x temp) + 0.7655] + 0.4

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

NOTE: If the FIO2 value is not at least 40, the shunt cannot be calculated.

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.

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.9
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
where
ctO2(c) = [OBF × tHb × (1–FCOHb–FMetHb)] + (0.00314 × A)

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

pH2O = 10[(0.0244 x temp) + 0.7655] + 0.4

For ctO2(a- ) entered, the system uses the default value of 3.5 mL/dL, or
whatever value is entered as the default value 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 pO2 and pCO2
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, pO2, pCO2. Clin Chem News
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 Replacing Supplies‚ page 2-2. To configure your system
according to the needs of your facility, refer to System Configuration‚ page 8-1.

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 Keyboard to use the
alphanumeric keyboard.
To enter lower- or upper-case characters, select LOCK. The LOCK button
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.

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 recommended
precautions when working with biohazardous materials.

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 recommended
precautions when working with biohazardous materials.
1. Select Status > Wash Cartridge > Replace > Yes.
2. Follow the instructions in the video.

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 recommended
precautions when working with biohazardous materials.

1. Select Status > Reagent Cartridge > Replace > Yes.

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

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

02087462 Rev. V
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, O2, or nitrous oxide. The risk of explosion exists in a potentially
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 occurred 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 calcium, you can use a maximum of 15
units of lithium heparin for each 1.0 mL of sample. If you are not analyzing
samples 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 pCO2 values;
however, venous pO2 values may not be significant in routine
clinical studies without simultaneous study of arterial pO2.
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 Mixed venous (pulmonary artery) blood may be obtained from a
blood 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.

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 pO2, glucose, and lactate values, because the sample consumes
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 mM/hour at 4°C and
1.0 mM/hour at 37°C.1 The rate of oxygen consumption depends on several
factors:
• Storage temperature
• 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 O2 gradients, or shunt studies,
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 pCO2, however, this affects the K+
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 (ClO4¯), thiocyanate (SCN¯), iodide
(I¯), and nitrate (NO3¯), because they falsely elevate chloride levels.
• 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.

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 recommended
precautions when working with biohazardous materials.

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


7. If prompted, enter demographic information and select 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 Continue when you finish viewing the results.

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


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.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-13

NOTE: If you have a priority sample, but the system displays a message that
the system is busy, select Cancel to interrupt the system. If Cancel is not
available, wait until the system is not displaying the busy message to analyze
the patient sample.
2. At the Analysis screen, select the button for capillary sample type.
3. Scan the barcode for the patient sample, if required.
4. Hold the capillary tube at the end closest to the sample port and insert the tube
firmly in the sample port.

1 Inserting the capillary tube

Figure 2-3 Rapidlab 1200 Systems Sample Port

5. Select Analyze.
NOTE: If the system determines that insufficient sample is present or bubbles
are in the sample, you are prompted to position the sample as you would a
microsample. For information about analyzing microsamples, 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 Continue.
7. If prompted, enter demographic information and select Continue.

02087462 Rev. V
2-14 Rapidlab 1200 Operator’s Guide: Operating the System

NOTE: You can scan the patient ID and accession number in the appropriate field. For
information about entering patient sample 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 in printed reports,
refer to Viewing Patient Results‚ page 2-27.
9. Select Continue when you finish viewing the results.

CAUTION: If the wash that is performed after sample analysis does not
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 Microsamples
NOTE: Read this procedure completely before performing microsample analysis for the
first time.
Use this procedure to analyze patient samples when you know that you have insufficient
sample volume for routine analysis. The procedure allows the system to have time to
properly analyze a small volume sample.
The system analyzes the sample in 2 stages. First, the system analyzes pCO2 and pO2, and
then analyzes the remaining parameters. The system also measures pCO2 during the
second stage of the microsample if the pCO2 sensor still contains sample. Using the
following procedure, you position the sample at position 1 in the sample path to begin
analysis of pCO2 and pO2. For Rapidlab 1245 and 1265 systems, the microsample mode
does not analyze hemoglobin parameters.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
2. At the Analysis screen, select the button for the patient sample type (arterial, capillary,
venous, mixed venous).
3. Select Microsample.
4. Scan the barcode for the patient sample if required.
5. Insert the sample device into the sample port and select Analyze.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-15

For an illustration of the sample port, refer to Figure 2-3 Rapidlab 1200
Systems Sample Port.
6. When prompted, remove the sample device and select Continue.
7. To start the sample moving through the sample path, select Advance Sample.

CAUTION: Do not hesitate at any point during this procedure. The sample moves
a short distance through the sample path to position 1. If you do not select an
option for the next stage of the procedure within 30 seconds, the system starts a
wash sequence and the sample becomes unusable.

8. Watch the sample move into the sample path and when the sample reaches
position 1, select Stop Sample.

1 Sample position 1

Figure 2-4 Sample Position 1

9. Select Analyze.
Wait while the system analyzes pCO2 and pO2. After the system finishes the
analysis, it moves the sample to the remaining sensors.

02087462 Rev. V
2-16 Rapidlab 1200 Operator’s Guide: Operating the System

10. Watch the sample move through the sample path and inspect the sample path for
bubbles or gaps.
• Ensure that the trailing edge of the sample remains in contact with the sample/
ground temperature sensor.
• Ensure that the leading edge of the sample fills the reference sensor.

1 Sample/ground temperature sensor


2 Reference sensor

Figure 2-5 Measurement Module

If... Then...
bubbles or gaps are present, select Cancel.
no bubbles or gaps are present, select Analyze.
11. If prompted, enter demographic information and select Continue.
You can scan the patient ID and accession number in the appropriate field. For more
information about entering the data, refer to Entering Patient Sample Data‚ page 2-22.
12. View the results.
For information about how results are displayed on the screen and in printed reports,
refer to Viewing Patient Results‚ page 2-27.
13. When you finish viewing the results, select Continue.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-17

Analyzing pH and pH, Glu, and Lac Samples


Use this procedure to analyze patient samples for pH results only, or to report pH,
Glucose, and Lactate results.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
2. At the Analysis screen, select the button for the patient sample type (arterial,
capillary, venous, mixed venous).
3. Select pH or pH, Glu, Lac.
4. Scan the barcode for the patient sample, if required.
5. Insert the sample device into the sample port and select Analyze.

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 Continue.


7. Watch the sample move through the sample path and inspect the sample path
for bubbles or gaps.
If... Then...
bubbles or gaps are present, select Cancel.
no bubbles or gaps are present, select Analyze.
8. If prompted, enter demographic information and select Continue.
You can scan the patient ID and accession number in the appropriate field. For
more information about entering the data, refer to Entering Patient Sample
Data‚ page 2-22.
9. Select Continue.

02087462 Rev. V
2-18 Rapidlab 1200 Operator’s Guide: Operating the System

10. View the results.


For information about how results are displayed on the screen and in printed reports,
refer to Viewing Patient Results‚ page 2-27.
11. When you finish viewing the results, select Continue.

CAUTION: If the wash that is performed after sample analysis does not
completely clean the fluid path, you must 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 tHb Samples


Use this procedure to analyze samples for tHb, fractions, and oxygenation parameters on
Rapidlab 1245 and 1265 systems.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Observe all rules and guidelines in Collecting Patient Samples‚ page 2-7.
2. At the Analysis screen, select the button for the patient sample type (arterial, capillary,
venous, mixed venous).
3. Select tHb.
4. Scan the barcode for the patient sample if required.
5. Insert the sample device into the sample port and select Analyze.

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 Continue.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-19

7. If prompted, enter demographic information and select Continue.


You can scan the patient ID and accession number in the appropriate field. For
more information about entering the 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 in printed
reports, refer to Viewing Patient Results‚ page 2-27.
9. Select Continue when you finish viewing the results.

CAUTION: If the wash that is performed after sample analysis does not
completely clean the fluid path, you must 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.

02087462 Rev. V
2-20 Rapidlab 1200 Operator’s Guide: Operating the System

Using Custom Panels


When you define custom panels in Setup, the Analysis screen displays a set of custom
panels in the lower left of the screen. For procedures to define custom panels, refer to
Defining Custom Panels‚ page 8-11.

1 Custom panel buttons


2 Set buttons

Figure 2-6 Custom Panel Buttons

• Custom panels defined in Setup display at the Analysis screen.


• If at least 1 panel is defined in each of the 2 custom panel sets, buttons labeled 1 and 2
display at the Analysis screen. Use these buttons to select Set 1 or Set 2. Each set
contains 1-3 panels.
• You cannot view the custom panels in Set 1 and Set 2 at the same time. Selecting one
set at the Analysis screen deselects the other set.
• The Analysis screen only displays a custom button if you select parameters for that
panel. For example, if you only select parameters for 2 of the 3 panels in Set 1, only
those 2 panels display when you select Set 1.
• If you disable a parameter in Setup after selecting a custom panel that contains that
parameter, the system automatically removes that parameter from that panel.
• Only patient samples can be used with custom panels.
To use QC, AQC, or High G/L samples, deselect the custom panel.
• Only parameters for the selected custom panel display at the Analysis screen. To
display other parameters, you must deselect the custom panel.
NOTE: If a parameter on a selected custom panel is outside the defined QC range, that
parameter remains selectable so you can restore it. Refer to Restoring Parameters‚
page 4-12.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-21

Understanding System Behavior with Custom Panels


When you select a custom panel, the system responds as follows:
• The system disables any functions that you cannot use with custom panels.
• If you select a custom panel that contains the tHb parameter and then select
Microsample, the tHb parameter is removed from the custom panel while
performing that analysis.
• If you select a custom panel that does not contain the pO2 and pCO2
parameters and then select Microsample, the system does not perform the gas
measurement phase of the microsample measurement.
The Analysis screen does not display custom panels under some conditions:
• you did not define custom panels in Setup
• if you select a sample type other than a patient sample type, such as QC,
AQC, or High G/L
• if you select pH only, pH Glu Lac only, or tHb only modes

02087462 Rev. V
2-22 Rapidlab 1200 Operator’s Guide: Operating the System

Entering Patient Sample Data


The system displays the Data Entry screen during sample analysis. You enter data by
scanning the patient sample barcode and by entering patient information at the Data Entry
screen. You can scan the barcode before you begin analysis at the Analysis screen or at the
Data Entry screen.

Scanning Barcodes at the Analysis Screen


NOTE: You can restrict entry of the patient ID so only a barcode scanner can be used to
enter the patient ID. This minimizes errors that can occur if the patient ID is entered
manually. Refer to Selecting the Barcode Only Option for Patient ID Entry‚ page 8-25.
When you scan the patient ID barcode at the Analysis screen, the system does a search of
records on the system.
If the patient ID... Then the patient ID and...
is found, the last name is displayed on the Analysis screen.
The system enters the patient ID, name, sex, and date of
birth at the Data Entry screen.
is not found, the Not Found message is displayed on the Analysis screen.
The system enters only the patient ID at the Data Entry
screen.

Scanning Technique

LASER WARNING: Never look directly at the beam of a hand-held barcode


scanner or point the scanner at another person. Also, do not look at the
reflection of the beam from a shiny surface. For more information about laser
safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers.

Use the following technique to ensure that you operate the barcode scanner correctly:
1. Hold the scanner at an angle to the barcode without touching it, not directly over the
barcode.
2. Scan the entire barcode.
Move the scanner to the distance that allows the beam to scan every bar and space.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-23

Entering Patient Demographics


When the system displays the Data Entry screen, enter the demographic
information as required. When you select the button for a demographic, an
alphanumeric keyboard displays. When you select the field for a demographic, a
numeric keypad displays.

To display buttons in the standard keyboard format, select QWERTY.


To display buttons in alphabetic order, select ABCDEF.
To toggle between a lower- and upper-case keyboard, select LOCK.

NOTE: Select Clear to delete the data in the field or Clear All to delete the data in
all the fields.
NOTE: You can restrict entry of the patient ID so only a barcode scanner can be
used to enter the patient ID. This minimizes errors that can occur if the patient ID
is entered manually. Refer to Selecting the Barcode Only Option for Patient ID
Entry‚ page 8-25.
NOTE: You can deactivate the Patient List button so it is unavailable to select
patients at data entry screens. This eliminates the possibility of accidentally
selecting an incorrect patient from the patient list. To deactivate the patient list
button, at the Status screen select Secured Option > Analysis Options, and
deselect the Patient List button. The Patient List button is on by default.
1. Enter the Patient ID or enter the patient’s demographics.
• If a matching patient ID and patient data is available, the system
automatically displays the name, sex, and date of birth.
To enter the patient ID using the barcode scanner, select Patient ID and
then scan the patient ID barcode. The system enters the name, sex, and
date of birth if available.
• If entering the patient ID did not populate the other fields, select Patient
List to search for a patient ID.
Use Patient List to display the patient ID and name for the last 8 patients
entered. When you select a patient ID from the list and return to the Data
Entry screen, the system displays the patient ID, name, sex, and date of
birth, if available.
2. To manually enter the patient name, select Last Name.
3. Use the alphanumeric buttons to enter the patient name.
4. To enter the accession number using the barcode scanner, select Accession
No.
5. Scan the accession number barcode.

02087462 Rev. V
2-24 Rapidlab 1200 Operator’s Guide: Operating the System

The system enters only the accession number.


6. To enter data for additional demographics, select the down pointing arrow button.
7. After you finish entering all demographics, select Continue.

Early Demographics Data Entry


Selecting the Early Demographics option enables you to enter demographic data early in
the sample analysis process. For normal samples, you can enter data during sample
aspiration. For microsamples, you can enter data during microsample aspiration,
positioning, and verification.
NOTE: If you do not verify removal of the sample device before the system performs an
automatic wash following the completion of a sample measurement, an additional wash is
performed. Performance of an additional wash delays system availability and diminishes
sample throughput.

Enabling Early Demographics Data Entry


1. Select Setup > Secured Options > Analysis Options.
2. Select Early Demographics > Save.
Early Demographics is off by default.
When you select Early Demographics the Data Entry screen displays automatically when
the following actions are performed:
• You select a patient sample at the Analysis screen and insert a sample.
• You select Microsample mode at the Analysis screen and insert a microsample.

System Behavior During Normal Sample Analysis


• You must complete entering data before sample analysis proceeds.
• If you finish entering data but aspiration is not complete, the Wait screen displays until
aspiration completes. You are then prompted to remove the sample device and
analysis continues.
• If you finish entering data and aspiration is complete, you are prompted to remove the
sample device, and analysis continues.
NOTE: If the system detects insufficient sample to process a normal measurement,
data entry is interrupted and you are prompted to position the sample as a
microsample. If you do not complete entering data before analysis completes, data
entry may be interrupted and you may be prompted to verify the sample.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-25

System Behavior During Microsample Analysis


• If you finish entering data but aspiration is not complete, the Wait screen
displays. When aspiration completes you are prompted to remove the sample.
• If you do not finish entering data, and aspiration completes, the system may
prompt you to remove the sample.
• You may be prompted to verify the sample after the sample has been
positioned, if pO2 and pCO2 measurements are performed.
• When data entry is interrupted any data not saved or partially entered is lost.
• After an interruption to position or verify a microsample the following
behavior occurs:
• You are returned to the Data Entry screen.
• The field that was active when the interruption occurred is highlighted
when you are returned to the screen.
• If you were at a submenu of the Data Entry screen when data entry was
interrupted, such as the alphanumeric keypad, you are returned to the
Data Entry screen, and the last active field in the Data Entry screen is
highlighted.

Using the Save Demographics Option


Use the Save Demographics option when you are analyzing samples for the same
patient. This option allows you to re-enter the demographic information from the
previous sample when analyzing a sample from the same patient.
To use this option during patient analysis, perform the following steps:
1. At the Data Entry screen, select Last Patient.
This automatically re-enters the demographics from the previous sample.
2. If the demographics from the previous patient are not correct for the current
sample, select Clear All.
This deletes the information. For more information about the Save
Demographics option, refer to Selecting the Save Demographics Option‚
page 8-38.

Editing Demographics
NOTE: You can edit demographics if you turned on this option in Setup. For more
information about selecting this option, refer to Selecting Demographics Editing‚
page 8-39.
Use this procedure to edit patient or sample demographic data, such as the patient
name or temperature, for previously analyzed patient samples.
If you edit the name, sex, or date of birth, the system applies the changes to all
samples saved for the patient. You can also print a patient sample report with the
edited data and send the data to a data management system or an LIS.

02087462 Rev. V
2-26 Rapidlab 1200 Operator’s Guide: Operating the System

NOTE: If you change a Patient ID (1234) to another patient ID (5678) that already exists,
the system replaces the name, sex, and date of birth for the edited patient ID (1234) with
those of the new patient ID (5678).
NOTE: You cannot edit data after you combine samples for a-v study reports.
1. Select Recall > Patients.
2. Locate the sample you want to edit.
If you want to... Then...
view additional a. Select the up or down arrow buttons to move through
samples, the list.
b. Select the sample you want to edit and select Results.
search for a sample a. Select Search.
by patient ID, b. Select Clear to delete the current patient ID.
c. Enter the patient ID and select Continue.
To return to the complete list of samples, select
Previous.
d. Select the sample you want to edit and select Results.
3. To display the demographic fields, select Edit.
4. Edit the demographic data.
5. Select Continue.
This displays a dialog box asking if you want to save the changes.
6. Select Yes.
7. To print the patient sample report, select Print.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-27

Using Patient Results


This section provides information about viewing and recalling patient results.

Viewing Patient Results


After you complete the Data Entry screen, the Results screen displays.
• The screen displays result values in yellow while analysis is in progress.
Preliminary results are not displayed if the system is performing additional
calibrations during analysis.

CAUTION: Only use final results for diagnostic purposes. Never use preliminary
results because using preliminary results can lead to misdiagnosis.

• The Results screen displays a parameter as gray if a result cannot be reported


because of system problems, such as a parameter that failed QC.
• The Results screen does not display a parameter if you did not enter a required
value, such as the temperature for a temperature corrected value.
• The Results screen displays the following symbols in red.
These symbols display with the results on the screen and in the printed report:
This symbol... Indicates that...
↑ the result is above the patient expected range.
Ø the result is below the patient expected range.
-----↑ the result is above the reporting range.
-----↓ the result is below the reporting range.
# the system detects the presence of substances in the sample that
may interfere with measurement.
-----? the system has an atypical response when measuring this parameter
and cannot report the result.
< the result is less than the analytical range limit.
> the result is greater than the analytical range limit.

02087462 Rev. V
2-28 Rapidlab 1200 Operator’s Guide: Operating the System

Use buttons on the Results screen to perform functions:


To do this... Then select...
View results for more parameters, More Results.
Send the report to a data management system or an LIS, Send.
Print the report, the Print button.

If your system is set to Auto Print, the report prints automatically. Refer to Defining Send
System Data Option‚ page 8-26.

Performing a Patient Search


You can search for patient data using the following criteria:
• Patient ID
• Last Name
• Accession Number
• Operator ID
• Start Date
• End Date

Patient Search Guidelines


• Each criterion, except Start and End Date, must first be enabled in Setup.
If you want to enable... Then...
Patient ID or Last Name a. Select Setup > Sample > Patient
Demographics.
b. Select one or more criteria.
c. Select Save.
Accession Number or a. Select Setup > Sample > Sample
Operator ID Demographics.
b. Select one or more criteria.
c. Select Save.
• Multiple criteria can be selected simultaneously.
• Results are returned only if patient records meet all entered criteria.
• Results for multiple patients are returned if multiple patients meet the entered criteria.
• Start and end dates are always available as patient search criteria.
• If Exact Match is selected and the field associated with Exact Match is blank, results
are only returned for patients for whom that criterion field is blank.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-29

Performing a Patient Search


1. Select Recall > Patients > Search.
2. In the Search criteria fields, enter data matching one or more search criteria.
• To enter alphanumeric characters select the criterion button.
• To enter numeric characters, select the criterion field.
3. For an exact match, select the Exact Match checkbox that is adjacent to the
criterion.
Only matches containing the exact data entered in the search field are
returned. For example, if 123 is entered, only 123 is returned as a result. If
Exact Match is not selected, entering 123 can return results such as 123456 or
456123.
4. Select Continue.
At the Patient screen, a table displays patient results.
• A blank field indicates no results were returned for that field.
• If a search fails to find a patient, the table displays without results.
• Use the arrow keys to access results off-screen to the right in the table, if
needed.
5. To review detailed results or print results, select Results.
If results for more than one patient are returned, you must first select the
patient by selecting the patient row on the screen.
A results screen for the selected patient displays. In addition to the results
information that displays at the table on the previous page, this screen shows
units of measurement and displays negative results in red text.
6. Print results by selecting the Print icon at the Results screen.

02087462 Rev. V
2-30 Rapidlab 1200 Operator’s Guide: Operating the System

Recalling Patient Sample Results


Use the Recall screen to view and print results for previously analyzed patient samples.
You can also send the recalled results to a data management system or a laboratory
information system (LIS).
For more information about changing demographic data for previously analyzed patient
samples, refer to Editing Demographics‚ page 2-25.
1. At the Analysis or Status screen, select Recall > Patients.
The list of patient samples are displayed.
2. Select the sample or locate the patient sample results you want to view.
If you want to... Then...
view additional a. Select the up or down arrow buttons to move
samples, through the list.
b. Select the sample you want to view.
search for a sample by a. Select Search.
patient ID, b. Select Clear to delete the current patient ID.
c. Enter the patient ID and select Continue.
d. Select the sample you want to view.
3. View the results for the selected sample:
a. Select Results.
b. Select More Results to view results for other reported parameters.
c. Select Print to print the patient sample report.
d. Select Send to send results to a data management system or an LIS.

Interpreting the Patient Recall Screen Symbols


The following symbols may be displayed on the Patient Recall screen:
Symbol Definition
a arterial sample
v venous sample
c capillary sample
mixed venous sample
a- a-v study sample
µ microsample, pH or pH, Glu, Lac sample
D code or message exists for this sample

demographics were edited

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-31

Printing Reports
You can print reports using the internal printer and, when installed, an external
printer. You can use the Setup–Printer Options screen to determine which printer
to use, how many copies to print and if the report is printed automatically. Refer to
Selecting Printer Options‚ page 8-22.

Procedural Notes for Printing Reports


• Each report contains the report name and the system name you created in the
Setup–Other Options screen.
Refer to Setting up Other Options‚ page 8-21.
• You can print most reports on either printer or both printers.
The only exceptions are the Maintenance Schedule and the Levey-Jennings
reports. You must print these reports on the external printer.
• The system filters error messages so that it only prints messages that affect the
reported results.
• The system disables the Print button when no paper is available in the
printers.

Printing Reports on the Internal Printer


For reports printed on the internal printer, the system feeds sufficient paper at the
end of every report to provide a “tear-off margin.”

02087462 Rev. V
2-32 Rapidlab 1200 Operator’s Guide: Operating the System

Printing Reports on the External Printer


For reports printed on the external printer, the system formats the report with
approximately a 1-inch margin from each edge of the 8-1/2 X 11-inch page or A4 paper.
When a report runs to multiple pages, the following rules apply:
• The system identifiers are only on the first page.
• Page breaks occur when the printing reaches the end of the page.
• The report does not display any headers, footers, or page numbers.

Using Available Reports


The system offers the following reports:
Report Name Description
Arterial-Venous Study Report Provides an a-v study report.
Only available on Rapidlab 1245 and
1265 systems.
Refer to Combining Results for an a-v
Study Report‚ page 2-35.
QC Sample Report Provides a report of QC results performed
or recalled.
Refer to Recalling QC Results‚ page 4-7.
QC Report, High G/L Provides a report of the High G/L test.
Refer to Analyzing High G/L‚ page 5-3.
AutomaticQC Report Prints a report of an AutomaticQC sample,
performed or recalled.
Refer to Using the AutomaticQC Analysis
Option‚ page 4-3.
Calibration Report–Full Report Prints a report for calibrations if you
selected Full in Setup.
Full means with measurement results and
drifts.
Refer to Selecting Printer Options‚
page 8-22, and Generating Calibration
Reports‚ page 3-3.
Calibration Report–System Status Report Prints a report for calibrations if you
selected Status in Setup.
Status means a summary of parameter
calibration pass or fail states.
Refer to Selecting Printer Options‚
page 8-22 and Generating Calibration
Reports‚ page 3-3.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-33

Report Name Description


Sample Totals Prints a report of the total number of
patient and QC samples performed on the
system.
Refer to Viewing the Sample Totals‚
page 7-4.
Last Cal Reports Prints data for each sensor from the last
2-point or full calibration.
Refer to Using the Sensors Screen‚
page 6-44.
Printer Report Prints all of the printable characters in the
printer memory.
Refer to Performing Tests and Printing
Diagnostic Reports‚ page 6-34.
Temperature/pAtm Report Prints an index and one snapshot of the
heater readings.
Refer to Performing Tests and Printing
Diagnostic Reports‚ page 6-34.
Lamp Calibration Report Prints a Pass/Fail value for the CO-ox
lamp calibration. Only available on
Rapidlab 1245 and 1265 systems.
Refer to Performing the Lamp Calibration
Test‚ page 6-45.
Wavelength Calibration Report Prints the result of the Wavelength
Calibration test. Only available on
Rapidlab 1245 or 1265 systems.
Performing the Wavelength Cal Test‚
page 6-46.
Sample Chamber Report Prints a Pass/Fail value for the result of
the Sample Chamber test. Only available
on Rapidlab 1245 and 1265 systems.
Refer to Performing the CO-ox Sample
Chamber Test‚ page 6-46
Voltages and Temperature Report Prints the historical Pass/Fail condition of
all voltages and temperatures.
Refer to Performing Tests and Printing
Diagnostic Reports‚ page 6-34.
Leak Test Report Prints the result of the Leak Test.
Refer to Performing the Leak Test‚
page 6-37.
Measurement Test Report Prints measurement readings for all
sensors.
Refer to Performing Tests and Printing
Diagnostic Reports‚ page 6-34.

02087462 Rev. V
2-34 Rapidlab 1200 Operator’s Guide: Operating the System

Report Name Description


QC Material Setup Report Prints the setup information for the
selected lot of QC material.
Refer to Using the Recall QC Data Search
Screen‚ page 4-8.
QC Statistics Report Prints a summary of the QC statistics for
the selected lot of QC material.
Refer to Viewing the Recall–QC Statistics
Screen‚ page 4-9.
QC Levey-Jennings Report Prints the Levey-Jennings graph as
displayed on the QC screen.
Refer to Viewing the Recall–
Levey-Jennings Graph Screen‚ page 4-11.

Performing a Correlation Study


To correlate the results from the Rapidlab 1200 system to a reference analyzer, change the
slope and offset (intercept) values for each parameter. Before changing these values,
analyze a range of samples at the Rapidlab 1200 system and at the reference analyzer.
Perform regression analysis on this data to obtain the slope and offset values to enter at the
system.
This procedure requires the following materials:
• Reference analyzer
• Sample population of at least 100 samples
The sample population is to generate a random distribution of values throughout the
upper and lower limits of the analytical and reporting ranges.

CAUTION: Do not change correlation coefficients unnecessarily. Changing


correlation coefficients affects the reported results for patient samples.

1. Verify that the current coefficients are 1.0 for the slope value and 0.0 for the offset
value:
a. Select Status > Setup > Secured Options.
b. Select the down arrow button and then select Correlation Coefficients.
c. Ensure that the slope value is 1.0 and the offset value is 0.0 for each parameter
that you want to adjust.
NOTE: Analyze the samples in duplicate at each system, if possible. Perform analysis
over several days to include normal analytical variability for both systems.
2. Analyze each sample concurrently at the Rapidlab 1200 system and at the reference
analyzer.
Do not allow more than 3 minutes between analyses of the same sample at each
system.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-35

3. Remove statistical outliers from the data by eliminating values outside


of ±3 SD.
NOTE: Ensure that you include a significant number of results at the
extremes of the concentration ranges. If you do not, it could compromise the
quality of the correlation.
4. Perform a regression analysis.
Perform the analysis using a computer that can calculate the regression by the
Deming algorithm. This algorithm provides debiased slope and offset and is
the recommended method. A less acceptable alternative is to perform the
linear regression on a calculator or computer that does not use the Deming
algorithm.
The correction equation must be in the following form:
y = mx + b
where m is the slope and b is the offset
Use the results from the Rapidlab 1200 systems as the independent variable
(x). Use the results from the reference analyzer as the dependent variable (y).
NOTE: You must perform the calculations as described above. The
calculation of a correction equation is the mathematical inverse of the
traditional correlation equation. Failure to calculate the regression as
described above produces an inaccurate correlation with the reference
analyzer.
5. Enter the slope and offset values.
Refer to Setting up Values‚ page 8-19.

Combining Results for an a-v Study Report


Use this procedure to combine the results from an arterial and a mixed-venous
blood sample to create an a-v study report. You can combine results only for
Rapidlab 1245 or 1265 systems. Arterial blood sample results can only be
combined with mixed-venous blood sample results and not venous blood sample
results.

02087462 Rev. V
2-36 Rapidlab 1200 Operator’s Guide: Operating the System

Before You Begin


Analyze the arterial and mixed venous syringe samples on a Rapidlab 1245 or 1265
system. Ensure that the samples meet the following requirements:
• The difference between analysis times of the 2 samples on the Rapidlab 1245 or 1265
system is less than 60 minutes.
• The patient IDs are identical, or only 1 of the 2 samples has a patient ID, or neither
sample has a patient ID.
• The results must be within the reporting ranges for pO2, tHb, and FO2Hb; if any of
these results are beyond the reporting range, the sample results cannot be combined.
NOTE: After combining sample results, only the new combined results for the a-v
sample are available on the Recall screen. This sample contains the arterial sample
results and the a-v results.

Setting up the Data


1. Select Recall.
NOTE: If you want to edit the demographic data for samples you want to combine,
you must edit the data before you combine the samples. For information about editing
demographics, refer to Editing Demographics‚ page 2-25.
2. Select Patients.
3. Locate 1 of the sample results you want to combine:
If you want to... Then...
view additional samples, select the up or down arrow buttons to move through
the list.
search for a sample by a. Select Search.
patient ID, b. Enter the patient ID and select Continue.
4. Select the sample you want to combine.
5. Select Combine.
The list now shows only samples that can be combined with the first sample selected.
6. Select the sample you want to use to combine results and then select Combine.
The system prompts you to enter the value for the patient’s cardiac output (Qt).
7. Enter the cardiac output value, if available, and then select Continue.
8. View the results.
For information about how results are displayed on the screen and in printed reports,
refer to Viewing Patient Results‚ page 2-27.
9. Select Continue when you finish viewing the results.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Operating the System 2-37

Printing the Arterial-Venous Study Report


The printed a-v study report shows the following from the mixed-venous sample:
• a-v results
• arterial sample results
• pO2, tHb, and FO2Hb results from the mixed venous sample
• patient ranges, if you selected Ranges at the Setup–Printer Options screen
Depending on the options selected in Setup, the parameters you analyze, and the
values you enter, the report format may be different for your system.

02087462 Rev. V
2-38 Rapidlab 1200 Operator’s Guide: Operating the System

02087462 Rev. V
3 Calibration

Calibration is the process of testing and adjusting the electronic signal from a
sensor in response to a known concentration. Calibration establishes a relationship
between the electrical signal of a sensor and the concentration of the analyte
measured by the sensor. The relationship between the sensor signal and the
concentration (or the log of the concentration) of a measured analyte is linear.
The system determines a straight line calibration curve by measuring the sensor
signal from 2 different reagents of known concentration. Each measurement
defines 1 point on the calibration curve. The system calculates the calibration
offset (y-intercept) and slope using the measured signal and known concentration
as established on the calibration curve. The system determines the concentration
of an unknown patient sample or QC sample by comparing its generated signal
during measurement to the established calibration curve.

Understanding Automatic Calibrations


Calibration of the Rapidlab 1200 systems occurs automatically at prescribed
intervals and requires no operator action.
NOTE: The system can defer a calibration to analyze a sample. In this case, the
message informing you that the system is busy contains a Cancel button that lets
you interrupt the calibration. However, if the maximum time between automatic
calibrations has elapsed, the system must complete the calibration before allowing
sample analysis.
The system automatically calibrates the sensors as in the following table:
Calibration
Type Frequency Description
1-Point Maximum of 30 or 60 minutes Measures 1 reagent of known
between calibrations. concentration to adjust either the
The system determines the offset or the slope for the
interval by sensor drift. following parameters: pH, pCO2,
You can manually initiate this pO2, Na+, Ca++, K+, Cl¯, Glu,
calibration. and Lac.
Full Every 8 hours. Measures 2 reagents of known
You can manually initiate this concentration to adjust either the
calibration. offset or the slope drift for all*
parameters.
This calibration also calibrates
the fluid detectors.
* Includes the parameters listed in the 1-point calibration description plus tHb and CO-ox
fractions.

02087462 Rev. V
3-2 Rapidlab 1200 Operator’s Guide: Calibration

The system performs the following calibrations after some maintenance procedures:
Calibration
Type Frequency Description
2-Point During accelerated calibration Measures 2 reagents of known
intervals, which occur after you concentration to adjust either the
perform sensor maintenance. offset or the slope drift for the
You can manually initiate this following parameters: pH, pCO2,
calibration. pO2, Na+, Ca++, K+, Cl¯, Glu, and
Lac.
Rapidlab 1245 and 1265 systems:
measures 2 reagents of known
concentration to adjust the offset
and the slope for tHb and CO-ox
fractions.
1-Point Plus Rapidlab 1245 and 1265 systems: Measures 1 reagent of known
after you replace the CO-ox concentration to adjust either the
sample chamber. offset or the slope for the
following parameters: pH, pCO2,
pO2, Na+, Ca++, K+, Cl¯, Glu, and
Lac.
Measures 2 reagents of known
concentration to adjust the offset
and the slope for tHb and CO-ox
fractions.
Accelerated The system starts accelerated The system performs a 2-point
Calibration calibration intervals in 2 instances calibration every 2 hours for the
Intervals after you open and close the first 8 hours of the accelerated
measurement module door: calibration interval.
If you answer the question “Did
you remove or replace any
sensors?” with Yes, or if you
answer with No and the system
detects a drop in pressure in the
sample path. The system only
detects a drop in pressure if you
followed the procedure Replacing
the Sensors‚ page 5-29.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Calibration 3-3

Troubleshooting Failed Calibrations


If the system detects a problem for a parameter during calibration, the system
repeats the calibration up to 2 times. The maximum number of repeat calibrations
is 2.
The system displays the Additional Cal Required message in the printed report
and in the events log. If the calibrations are not successful, the system turns the
parameter off. You can continue to obtain results for the other parameters.
To perform a manual calibration, refer to Performing Manual Calibrations‚
page 3-4. If the parameter does not pass calibrations successfully, you may need to
perform troubleshooting tasks. Refer to Troubleshooting Failed Calibrations‚
page 6-4.

Generating Calibration Reports


The Rapidlab 1200 system offers 2 calibration report formats: full or status.
• The full report shows the measurement and drift values, and the D code that
explains the result symbols.
If the system cannot report a value during a calibration, the result is blank on
the full reports.
• The status report describes the calibration results as passed or failed and
identifies any failed parameters.
Depending on the system setup, if the system is connected to a Rapidlink or
Rapidcomm data management system or to an LIS, the system automatically
sends the calibration data to these computer systems. For more information about
Automatic Send, refer to Setting up Auto Send Options‚ page 8-32.

02087462 Rev. V
3-4 Rapidlab 1200 Operator’s Guide: Calibration

Performing Manual Calibrations


Use this procedure to manually start a 1-point, a 2-point, or a full calibration. Only
operators with the required security access can start a calibration. For more information
about levels of security access, refer to Setting up Operator Security Levels‚ page 8-35.
NOTE: When you access the Calibration screen, some calibration types may not be
available because an automatic calibration is scheduled to begin shortly. For example, a
1-point calibration is not available if a full 2-point calibration is scheduled to start within
10 minutes.
1. Select Status > Calibrate.
2. Select the calibration type.
3. Select Start.
The system displays a message indicating that the system is busy. The message box
displays the time remaining until the calibration finishes and a Cancel button so you
can interrupt the calibration to analyze a priority sample.
• If a parameter fails the calibration, the calibration repeats.
• If a parameter continues to fail calibration, refer to Troubleshooting Failed
Calibrations‚ page 6-4.

Recalling Calibration Results


1. Select Recall > Calibrations.
The screen displays the list of calibrations by date and time. The list indicates whether
the calibration was a 1-point, a 2-point, or a full calibration. The list also indicates
whether any diagnostic messages are associated with the calibration.
2. Use the up and down arrows to view all the calibrations.
To view the measurement and drift values, if available, ensure that you select the full
calibration report in the printing options. Refer to Selecting Printer Options‚
page 8-22.
3. To print the calibration report, select a calibration and then select Print.
4. To send results to a data management system or an LIS, select Send.

02087462 Rev. V
4 Quality Control

Your laboratory should have procedures for analyzing the number of QC samples
and levels of QC material for each day of testing. Use only RapidQC® Complete
controls or install the AutomaticQC cartridge.
In addition to daily QC monitoring, participation in interlaboratory QC survey
programs lets you compare your system performance with systems in other
laboratories. Participation in interlaboratory QC survey and proficiency testing
programs can identify systematic errors not detected by intralaboratory QC
testing alone.

Performing QC Sample Analysis


NOTE: Treat all QC materials as you do patient samples.

The Rapidlab 1200 system offers 3 options for quality control analysis. Refer to
Setting Up QC Options‚ page 8-2:

Required QC analysis The system schedules QC analysis and prompts you to


analyze the QC samples.
AutomaticQC analysis The system automatically analyzes the QC samples.
Unscheduled QC analysis You analyze the QC samples when you want.

Using the Required QC Analysis Option


Required QC Analysis helps ensure that operators analyze controls according to
the protocol established in your institution.
If you have Required QC analysis set to On, the system prompts operators to
analyze specific levels of controls at intervals that you define. You must use
RapidQC materials to perform Required QC analysis.

Performing Required QC Sample Analysis


If the system displays the Required QC Due 00:00 message on the banner, use
this procedure to analyze Required QC samples. The system displays the number
of hours and minutes during which you can analyze the samples next to the
message.
1. At the Analysis screen, select QC!.
2. When prompted, introduce the level of the control shown on the screen:
a. Scan the barcode on the QC ampule.
b. Carefully snap open the ampule.

02087462 Rev. V
4-2 Rapidlab 1200 Operator’s Guide: Quality Control

c. Attach a Quick® adapter to the ampule.


d. Insert the adapter with the attached ampule into the sample port as shown on the
screen.
e. Select Analyze.
The system aspirates the sample.
f. When prompted, remove the Quick adapter from the sample port and then select
Continue.
3. If prompted, enter your operator ID and then select Continue.
4. View the results on the screen and in the printed report.
If you turned on the Auto Print option in Setup, the system automatically prints the
QC sample report.
5. When you finish viewing the results, select Continue.
If... Then...
you are prompted to select Yes and repeat this procedure starting at step 2.
repeat analysis because You can select No if you do not want to repeat the analysis.
1 or more parameters is The system returns to the Analysis screen and turns off the
out of range, parameters that failed QC analysis. You cannot report results
for these parameters until an authorized operator restores the
parameters. Refer to Restoring Parameters‚ page 4-12.
1 or more parameters is the system returns to the Analysis screen and turns off the
out of range for the parameters that failed QC analysis.
second time You cannot report results for these parameters until an
authorized operator restores the parameters. Refer to
Restoring Parameters‚ page 4-12.

Procedural Notes for Required QC


When you perform a Required QC sample analysis, the system verifies that you scanned
the correct ampule for the scheduled control material. The system checks the results
against the ranges defined for each parameter for that level of the control. The system
identifies any results that are out of range.
The system allows you to analyze Unscheduled QC samples in addition to scheduled
Required QC analysis, but the results of the Unscheduled QC have no affect on parameter
status.
Depending on the options you selected in Setup, the system prints a QC sample report. If
the system is connected to a Rapidlink or Rapidcomm data management system or to an
LIS, the system automatically sends the QC results to these computer systems.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Quality Control 4-3

Using the AutomaticQC Analysis Option


To use the AutomaticQC analysis feature, you must select the AutomaticQC
option in Setup and have an AutomaticQC cartridge on your system. The
AutomaticQC cartridge contains all the levels of QC material needed to monitor
system performance without operator intervention. The target ranges for each
level of QC material automatically update when you replace the cartridge.
AutomaticQC analysis ensures that system automatically monitors performance
according to the protocol established in your institution.
NOTE: The target ranges from the AutomaticQC cartridge more closely represent
system performance than target ranges from QC material supplied in ampules.
The system allows you to edit ranges, if necessary, but it is not recommended.

Performing AutomaticQC Sample Analysis


The system performs AutomaticQC analysis without operator intervention. The
AQC Pending 00:15 message displays in the banner 15 minutes before the
system begins the AutomaticQC. Select QC! to begin the scheduled QC analysis
sooner.

Manually Performing AutomaticQC Analysis


The system allows you to manually initiate analysis of a QC sample from the
AutomaticQC cartridge. When you initiate analysis of an AutomaticQC sample,
the results can affect parameter status. The system turns on parameters that pass
QC analysis and turns off parameters that do not pass QC analysis. If you analyze
unscheduled QC samples from an ampule, the results do not affect parameter
status.
NOTE: You cannot change the level of AutomaticQC analysis that you want to
run when QC! displays on the screen. Select the QC! button and the system
performs the pending AutomaticQC samples. After the system performs all
pending QC samples, you can perform QC on any level.
1. Select the button for the AutomaticQC sample type.
2. Select Analyze.
3. Select the level that you want to analyze and then select Start.
4. If prompted, enter your operator ID and then select Continue.
5. View the results on the screen and on the printed report.
If you selected the Auto Print option in Setup, the system automatically prints
the QC sample report.
6. When you finish viewing the results, select Continue.

02087462 Rev. V
4-4 Rapidlab 1200 Operator’s Guide: Quality Control

Procedural Notes for AutomaticQC Sample Analysis


The system compares the QC results to the ranges for each parameter and identifies results
that are out of range. The system turns off parameters that fail QC. Depending on the
options defined in Setup, the system repeats the QC analysis if the first attempt fails and
the system turns on failed parameters that pass. The system turns off parameters that fail
the second QC analysis.
During AutomaticQC analysis, the system displays the levels of QC to analyze and
indicates the progress of analysis for scheduled levels.

Performing STAT Samples during AutomaticQC Analysis


You can interrupt AutomaticQC analysis between levels if you need to analyze a STAT
patient sample.
1. At the AutomaticQC Results screen, select STAT.
This delays analysis of the next level of QC material.
2. When the system is ready, analyze your patient sample.
The system analyzes any remaining levels of QC after you finish.

Using the Unscheduled QC Option


Unscheduled QC is the default option for QC analysis. Use this option if you do not want
to perform scheduled QC analysis using Required QC or AutomaticQC analysis. You can
still analyze QC material, but parameter status is not affected by QC results. Parameters
are not turned off if they fail or turned on if they pass QC analysis.

Performing Unscheduled QC Sample Analysis


Use this procedure to manually analyze routine QC samples from an ampule with a Quick
adapter or from a syringe. Barcoding is not necessary but is available if you use
Siemens Healthcare Diagnostics controls.
If you want to compare QC results to target ranges, you must define controls and target
ranges in Setup for Required QC, and use the barcode scanner and barcoded ampules of
QC material. Refer to Setting Up Required QC‚ page 8-3.
NOTE: When you perform Unscheduled QC, it does not affect the status of the
parameters. If parameters pass for a failed level, the system does not turn on a parameter
that was turned off. If the parameter fails, the system does not turn off those parameters.
1. Select the button for the QC sample type (ampule, syringe).

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Quality Control 4-5

2. Introduce the QC sample:


a. Scan the barcode on the QC ampule, if necessary.
b. Invert the QC ampule several times and then open the ampule.
c. Prepare the sample.
If the sample device is... Then...
an ampule attach a Quick adapter to the ampule.
a syringe draw the QC sample into the syringe.
d. Insert the sample device into the sample port.
e. Select Analyze.
f. When prompted, remove the sample device from the sample port and then
select Continue.
3. If prompted, enter your operator ID and then select Continue.
4. View the results on the screen and on the printed reports.
If the Auto Print option is turned on in Setup, the system automatically prints
the QC sample report.
5. When you finish viewing the results, select Continue.

Accessing QC Results
When the system completes QC analysis, the system displays the Results screen.
For a Required QC analysis and for Unscheduled QC analysis when you scan the
barcode on the ampule, the Results screen immediately under the banner contains
the following information:
• QC type
• Level
• Lot
For AutomaticQC samples, the system displays the level.

02087462 Rev. V
4-6 Rapidlab 1200 Operator’s Guide: Quality Control

Printing or Sending Results


At the Results screen, you can send the QC analysis results to your printer or to a data
management system or an LIS.
• To print a report, select the Print button.
• To send the report to a data management system or an LIS, select Send.
The report identifies the control and lists the target ranges as you defined them in Setup. A
legend at the bottom explains the results symbols used in the report.
If you select RiliBÄK range checking in Setup, the report contains an additional line with
the parameter target value and the percentage difference between the measured value and
target. The report also displays a “Failed” message if the measured value exceeds the
RiliBÄK range. Refer to Setting Up QC Options‚ page 8-2.

Result Flags
The system displays the following symbols in red on the results screen and in the printed
report:
This symbol... Indicates that...
¦ the result is above the target range.
Ø the result is below the target range.
-----↑ the result is above the reporting range.
-----↓ the result is below the reporting range.
-----? the system has an atypical response when measuring this
parameter.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Quality Control 4-7

Recalling QC Results
Use the Recall screen to view and print results for previously analyzed QC
samples. When you select the Recall button and then select QC, the Recall QC
screen displays the following options:
• QC List
• QC Statistics
• Levey-Jennings Graph

Using the QC List Screen


The QC List screen displays the QC results that are stored in the system. The list
box on the QC List screen displays Required QC, Unscheduled QC,
AutomaticQC, and High G/L results.
1. At Analysis screen, select Recall, and then select QC.
2. At the Recall QC Options screen, select QC List.
This displays the Recall QC Data screen.
• For AutomaticQC samples, the list uses AQC for the control name and
uses the last 6 digits of the cartridge serial number as the lot number.
• For Required QC samples, the system displays an arrow symbol next to
the date.
3. Locate the sample results you want to view:
NOTE: You can use the Search to find a specific result or to filter the results
according to criteria you select. Refer to Using the Recall QC Data Search
Screen‚ page 4-8.
a. Use the up or down arrow buttons to scroll through the screen of results.
b. Use the horizontal scroll arrows to view the Parameter values for the
selected sample result.
4. Select the sample and then select Results.
5. At the Results screen, you can perform the following tasks:
To do this... Select this...
reject results, You cannot undo this function. After you reject the
results, you cannot accept them again.
Reject Results.
The results are excluded from QC Statistics
calculations and plotted differently on
Levey-Jennings graphs.
print result, the Print button.
send results to a data Send.
management system or LIS,
6. Select Continue.

02087462 Rev. V
4-8 Rapidlab 1200 Operator’s Guide: Quality Control

Using the Recall QC Data Search Screen


The Recall QC Data Search screen allows you to search for a specific QC lot, QC sample
results performed between a defined date range, or a combination of criteria. The QC Data
Search screen acts as a filter to display only those results that meet the criteria you specify
on the Search screen.
1. At the QC List screen, select Search.
2. At the search screen, use the following search options to set your criteria:
NOTE: Use the number pad to enter your criteria where necessary.

Select this option... To do this...


Lot enter the lot number of the control you
want to view.
If you do not enter a lot number, the
system displays all lots that meet the other
criteria you define.
Start Date enter the earliest date for search on a range
dates.
The start date must be earlier than the End
Date.
End Date enter the latest date for a search on a range
of dates.
If you do not enter an end date, the system
uses the current day date.
Level 1, 2, 3 display QC results according to level.
You may use any combination of levels or
select all three.
Unknown to display samples when levels are not
identified.
High G/L to select only High G/L results.
You can use this in combination with the
other options.
3. When you are done selecting the criteria, select Continue.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Quality Control 4-9

Using the Recall–QC Statistics Screens


The Recall–QC Statistics screens allow you to select a particular lot of QC
material and then to view all the statistics for that lot.
To access the Recall–QC Statistics screens, perform the following steps:
1. At the Analysis or Status screens, select Recall.
2. At the Recall screen, select QC and then select QC Statistics.
3. At the Recall–QC Statistics screen, select the AQC Level or lot ID number for
the QC material.
Use the up and down scroll arrows to navigate the list. The list is in
alphanumeric order, with the AutomaticQC lots listed first as AQC1, AQC2,
and so on.
To narrow the date range for samples being analyzed, enter dates in the Start
and End date boxes, using the numeric keypad.
4. Select Continue.
A Wait screen displays during data analysis. When data analysis completes,
the QC Statistics screen displays QC Statistics.
The Recall–QC Statistics screen only displays accepted results. Any results
that are reported out of the range of the instrument or questionable are
excluded from these statistics.

Viewing the Recall–QC Statistics Screen


Under the banner, the Recall–QC Statistics screen displays the following lot
information for the currently displayed lot of QC material:
• QC material label, RapidQC Complete or AutomaticQC
• QC lot level
• QC lot number (does not display for Automatic QC)
• start date, the earliest date this lot was used according to these statistics
• end date, the most recent date this lot was used according to these statistics
In the QC Statistics list, the screen displays the following statistics for each
measured parameter:
• Mean Value

02087462 Rev. V
4-10 Rapidlab 1200 Operator’s Guide: Quality Control

The mean value is defined as the sum of all results divided by the number of results,
according to the following formula:

1 N x + x + L + xN
x= Σ xi = 1 2
N i =1 N
• SD(R), standard deviation with RiliBÄK range checking defined according to the
following formula:

1 n
RMSD= ∑(xi − xt arget )2
n i=1

• SD(R) as a percentage, standard deviation as a percentage with range checking


defined according to the following formula:

RMSD% = ( RMSD / xt arg et ) * 100

• SD( x ), standard deviation against the mean is defined according to the following
formula:

1 N
S= Σ ( xi − x ) 2
( N − 1) i =1
• CV, coefficient of variation is defined according to the following formula:

S
CV = ×100%
x
• N, number of samples included for these statistics.
NOTE: For RMSD and RMSD%, a minimum of 15 samples is required. If fewer than
15 samples are analyzed, the field is blank. For Standard Deviation and Coefficient of
Variation, a minimum of 5 samples is required. If fewer than 5 samples are analyzed,
the field is blank.
NOTE: If a sample is out of range it may skew QC Analysis results. To exclude a
sample you suspect is out of range, see Using the QC List Screen‚ page 4-7.
NOTE: Low and high AQC and RQC ranges are adjusted to adhere to the
RiliBÄK 2008 requirements that define deviation from target ranges.
NOTE: CO-ox fractions for FO2Hb, FCOHb, FMetHb, and FHHB are not adjusted.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Quality Control 4-11

To print the Recall–QC Statistics data, select the Print button. The printed report
contains the following additional information:
• parameter labels and statistics for all parameters
• measured and target values for each parameter
• the difference between the measured and target values, in percentage
• if a parameter exceeds the RiliBÄK range, text indicates the parameter has
failed

Using the Recall–Levey-Jennings Screens


The Recall–Levey-Jennings screens allow you to select a particular lot of QC
material and a parameter and then to view a month’s worth of data as a
Levey-Jennings graph.
NOTE: You must have defined range values for the system to generate a
Levey-Jennings graph.
1. At the user interface, select Recall.
2. At the Recall screen, select QC, and then select Levey-Jennings Graph.
3. At the Recall–Levey-Jennings Graph screen, select the lot number for the QC
material.
Use the up and down scroll arrows to navigate the list. The list is in
alphanumeric order, with the AutomaticQC lots listed first as AQC1, AQC2,
and so on.
4. Select a month.
The current month is uppermost of the three buttons. The 2 previous months
are next in order.
5. Select a parameter.
6. Select Continue.
This displays the Recall Levey-Jennings Graph screen.

Viewing the Recall–Levey-Jennings Graph Screen


The Levey-Jennings graph displays a visual representation of the performance of
the selected parameter relative to QC measurements for up to a 31-day period of a
single month.
Select the Print button to print the Levey-Jennings graph. You can only print the
Levey-Jennings graph to an external printer.
If you want more than one month of data, select and print one month and then
select and print another month.
Under the banner, the Recall–Levey-Jennings Graph screen displays the lot
information for the currently displayed lot of QC material:
• parameter label for the data displayed in the graph

02087462 Rev. V
4-12 Rapidlab 1200 Operator’s Guide: Quality Control

• QC material label, RapidQC Complete or AutomaticQC


• lot level
• lot number
• the month and year for the data displayed in the graph
The graph contains the following information:
• the X axis displays tick marks for 31 days of the month
• the Y axis displays the following
• the midpoint line represents the target value of the parameter
• the lines above and below the midpoint represent the 2SD levels labeled with the
values for 2SD
The low range limit is -2SD. The high range is +2SD. The system uses the
ranges for the most recent sample for these values.
• the 4SD levels are above and below the 2SD levels
• Data points are represented as follows:
• square, indicates an accepted data point within the range of +/- 4SD.
• diamond, indicates a rejected data point within the range of +/- 4SD.
• x, indicates a data point outside the range of +/- 4SD.

Restoring Parameters
Use this procedure to turn on parameters that the system turned off for either of the
following reasons:
• The parameter failed Required QC or AutomaticQC analysis, or was not available
when Required QC or AutomaticQC was performed.
• Required QC analysis was not performed when scheduled.
When you restore a parameter, the parameter remains selected and available for analysis
until the next scheduled QC analysis.
1. At the Analysis screen, select a parameter that is turned off.
NOTE: After you select a parameter, it remains selected and you cannot deselect it at
this screen.
2. At the Restore QC screen, select the parameters you want to restore and then select
Continue.

NOTE: For an AutomaticQC analysis, the screen displays parameters and levels that
failed analysis in the Failed QC list.
3. Analyze another QC sample for the failed level to ensure that the parameters are
within the target ranges.
If a restored parameter fails QC analysis, refer to Troubleshooting Failed or Missed QC
Analysis‚ page 6-1.

02087462 Rev. V
5 Maintenance

Preparing for Maintenance Procedures


Many of the procedures in this section require you to lift the door on the
measurement module.
1. Grasp both sides of the front cover and pull it toward you.
2. Lift the front cover.
3. Push up the latches on the measurement module door.
4. Lift the door.

1 Front cover
2 Latches–measurement module

Figure 5-1 Rapidlab 1200 System–Front Cover Open

02087462 Rev. V
5-2 Rapidlab 1200 Operator’s Guide: Maintenance

Performing Daily Maintenance


Daily maintenance includes the following tasks:
• Checking system status
• Cleaning and disinfecting the exterior surfaces

Checking System Status


1. At the system user interface, select Status.
2. View the percent volume for the waste bottle, and percent volume and expiration date
for each cartridge.
Replace the cartridges and the waste bottle, if necessary.
3. View the list of unresolved messages in the Events Log.
The system displays messages about current system conditions. Refer to Viewing
System Messages‚ page 6-74.
4. Check the barometer pressure.
Refer to Calibrating the Barometric Sensor‚ page 5-3.
5. Check the printer paper and replace it, if necessary.
Refer to Replacing the Printer Paper‚ page 5-42.

Cleaning and Disinfecting the Exterior Surfaces


You need the following materials for this task:
• Lint-free cloth
• 10% bleach solution

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Moisten the cloth with the bleach solution so that the cloth is wet but not dripping.

CAUTION: Do not allow bleach or other cleaners to contact the inside surface of
the sample port. The system could aspirate the cleaners and damage the sensors.
2. Wipe the exterior surfaces of the system using the wet cloth.
3. Allow the exterior surfaces to air dry.
4. Dispose of the bleach solution according to your institution’s protocol.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-3

Calibrating the Barometric Sensor


Use this procedure to calibrate the internal atmospheric pressure sensor to a
barometer in your laboratory. Check the barometer calibration every day.
1. At the user interface, select Status > Calibrate.
2. Measure the atmospheric pressure using a high-quality barometer that has
been calibrated to, or directly measures, actual atmospheric pressure.
3. Select pAtm.
4. Enter the correct atmospheric pressure and select Save.

Performing Twice Weekly Maintenance


The twice weekly maintenance schedule is based on analyzing 30 samples per
day, unless otherwise noted. If your laboratory analyzes more than 30 samples per
day, perform this maintenance more frequently.

Analyzing High G/L


Use this procedure to verify the performance of the Glucose and Lactate
biosensors on Rapidlab 1260 or 1265 systems. You analyze High G/L samples
using the Patient mode and no correlation coefficients, but the system recalls the
results as QC results.
The system measures Glucose and Lactate parameters for High G/L samples.
Because the system only displays parameters that you turned on in Setup, if you
turn off Glucose and Lactate in Setup, the system does not display the High G/L
option.
You need the following materials for this task:
• High G/L ampule
• Quick adapter
1. Perform a successful 2-point calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
2. Prepare the High G/L ampule.
3. Insert a Quick adapter into the sample port and onto the ampule.
4. Select the High G/L ampule type, and then select Analyze.
5. When prompted, remove the sample device from the sample port and select
Continue.
6. If prompted, enter demographic information and select Continue.
7. Review the results.

02087462 Rev. V
5-4 Rapidlab 1200 Operator’s Guide: Maintenance

8. If the Glucose or Lactate results are below the values recommended on the High G/L
package insert, replace the affected biosensor.
Refer to Replacing the Sensors‚ page 5-29.

Performing Weekly Maintenance


Except as stated in the procedures, the weekly maintenance schedule is based on analyzing
30 samples per day, unless otherwise noted. If your laboratory analyzes more than 30
samples per day, perform this maintenance more frequently.
Weekly maintenance includes the following tasks:
• Deproteinizing the sample path
• Conditioning the sensors
• Checking the fill solution levels in the sensors

Deproteinizing the Sample Path


If you are analyzing less than 200 samples per day, deproteinize and condition your
Rapidlab 1200 system weekly. If you are analyzing more than 200 samples per day, or if
your laboratory often processes certain types of blood, high hematocrit samples or blood
with high TPN, you may need to run this procedure more often. Monitor your system and
sensor performance, and adjust the frequency of this procedure as necessary.
You need the following materials for this task:
• Deproteinizer
• Syringe
• Glucose and Lactate test/blank sensors (TB4)

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not expose the glucose and lactate biosensors to bleach,


conditioner, or deproteinizer. Replace the biosensors with the test/blank sensors
(TB4) before conditioning the sensors or deproteinizing the sample path. Reinstall
the biosensors within 2 hours.

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-5

1. Prepare the deproteinizer as directed on the package.


2. Select Status > Maintenance > Deproteinizing the Sample Path.
3. Select Continue.
4. If you have a Rapidlab 1260 or 1265 system, replace the Glucose and Lactate
biosensors with the test/blank sensors:
a. Select the video button and follow the instructions in the video.
b. Select Continue.
5. Aspirate the deproteinizer:
a. Invert the deproteinizer vial several times to mix the contents.
b. Draw the deproteinizer into a syringe and insert the syringe into the
sample port.
c. Select Continue.
d. When prompted, remove the syringe and select Continue.
The deproteinizing cycle runs for 10 minutes. Any mechanical noise in
the area of the sample port is normal and dissipates after the system
analyzes a few blood samples.
6. At the prompt, select Yes to condition the sensors or No to skip this step.
Refer to Conditioning the Sensors‚ page 5-6.
7. If you are not conditioning the sensors and you have a Rapidlab 1260 or 1265
system, replace the test/blank sensors with the biosensors:
a. Select the video button and follow the instructions in the video.
b. Select Continue.
8. Select Return.
9. Select Analyze.
10. If you have a Rapidlab 1260 or 1265 system, select Yes.
11. Analyze a minimum of 2 levels of quality control material to verify sensor
performance.

02087462 Rev. V
5-6 Rapidlab 1200 Operator’s Guide: Maintenance

Conditioning the Sensors


Conditioning cleans and conditions the glass membranes of the pH and sodium sensors.
You need the following materials for this task:
• Conditioner
• Syringe
• Glucose and Lactate test/blank sensors (TB4)

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not expose the glucose and lactate biosensors to bleach,


conditioner, or deproteinizer. Replace the biosensors with the test/blank sensors
(TB4) before conditioning the sensors or deproteinizing the sample path. Reinstall
the biosensors within 2 hours.

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

1. At user interface, select Status > Maintenance.


2. Select Conditioning the Sensors.
3. Select Continue.
4. Select the video button and follow the instructions in the video.
5. If you have a Rapidlab 1260 or 1265 system, replace the Glucose and Lactate
biosensors with the test/blank sensors:
a. Select the video button and follow the instructions in the video.
b. Select Continue.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-7

6. Aspirate the conditioner:


a. Draw the conditioner solution into a syringe and insert the syringe into the
sample port.
b. Select Continue.
c. When prompted, remove the syringe and select Continue.
The conditioning cycle runs for 10 minutes.
7. If you have a Rapidlab 1260 or 1265 system, replace the test/blank sensors
with the biosensors.
8. Select Return.
9. Select Analyze.
10. If you have a Rapidlab 1260 or 1265 system, select Yes.
11. If you have a Rapidlab 1240 or 1245 system, perform a 2-point calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
12. Analyze a minimum of 2 levels of quality control material to verify sensor
performance.

Checking the Level of Fill Solution


Use this procedure to ensure that the sensors contain the correct level of fill
solution.
The pO2 and pCO2 sensors do not require maintenance. Slight discoloration of the
fill solution in the pO2 and pCO2 sensors is normal.

The Glucose and Lactate biosensors do not require fill solution.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

1. Select Status > Maintenance > Performing Sensor Maintenance.


2. Select Continue.
3. Lift the door to the measurement module.
Refer to Preparing for Maintenance Procedures‚ page 5-1.

02087462 Rev. V
5-8 Rapidlab 1200 Operator’s Guide: Maintenance

4. Check the level of fill solution in the reference sensor:


a. Verify that the reference sensor fill solution is above the fill line.
The fill line is on the right side of the KCl reservoir.
NOTE: The fill solution can become slightly pink as a result of analyzing QC and
AutomaticQC materials. A pink color that becomes very dark over a 12 hour
period indicates a pending failure of the reference sensor. When this occurs,
replace the reference sensor or the reference sensor cassette.
b. If the level of fill solution is low, fill the sensor.
Refer to Performing Reference Sensor Maintenance‚ page 5-34.

5. Check the level of fill solution in the K+, Cl¯, Ca++, Na+, and pH sensors:
a. Verify that the K+, Cl¯, and Ca++ sensors are almost full with a small (1 mm)
bubble at the top.
b. Verify that the pH and Na+ sensors are completely full.
c. If the level of fill solution is low, replace the fill solution.
Refer to Performing Measurement Sensor Maintenance‚ page 5-40.
6. Close the measurement module door and close the front cover.
7. Allow the system to warm up for 10 minutes.
8. Select Yes.
9. Select Continue > Return.
10. Select Analyze > Yes.
11. Analyze a minimum of 2 levels of quality control material to verify sensor
performance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-9

Performing Every 60 Days Maintenance


The every 60 days maintenance schedule is based on analyzing 30 samples per
day, unless otherwise noted. If your laboratory analyzes more than 30 samples per
day, perform this maintenance more frequently.

Replacing the CO-ox Sample Chamber


You need a new CO-ox sample chamber to perform this task.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Select Status > Maintenance > Replacing the CO-ox Sample Chamber.
2. To start the procedure, select Continue.
3. Follow the instructions in the video.
4. Allow the system to warm up for 5 minutes.
5. Perform a full calibration.
Refer to Recalling Calibration Results‚ page 3-4.
6. Analyze a minimum of 2 levels of quality control material.

Checking the Air Filters


1. Select Status > Maintenance > Replacing the Air Filter.
2. Select Continue.
3. To remove the filters, follow the instructions in the video.
4. Shake the filters to remove dust.
If the filters are torn or cannot be cleaned, replace the filters.
5. To reinstall the filters, follow the instructions in the video.

02087462 Rev. V
5-10 Rapidlab 1200 Operator’s Guide: Maintenance

Performing Quarterly Maintenance


The quarterly maintenance schedule is based on analyzing 30 samples per day, unless
otherwise noted. If your laboratory analyzes more than 30 samples per day, perform this
maintenance more frequently.

Replacing the Pinch Valve Tubing


You need a tubing kit for this task.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. At the user interface, select Status > Diagnostics > Cartridges.


2. Select Eject R Cartridge.
3. Lift the door on the measurement module.
Refer to Preparing for Maintenance Procedures‚ page 5-1.
4. Remove the old tubing:
a. Remove the tubing from the connector at the spring-loaded latch.

1 Connector at the spring-loaded latch


2 Pinch valve
3 Pinch valve tubing
4 Pressure sensor bubbler

Figure 5-2 Measurement Module–Rapidlab 1260 and 1265 Systems

b. Pull the tubing out of the pinch valve.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-11

c. Disconnect the tubing from the connector at the pressure sensor bubbler.
5. Connect the new tubing:
a. Connect the new tubing to the spring-loaded latch.
b. Push the new tubing into the pinch valve.
Center the tubing and ensure the tubing does not have any sharp bends.
c. Connect the new tubing to the pressure sensor bubbler.
6. Close the measurement module door.
7. Select No.
8. Reinstall the reagent cartridge and close the reagent cartridge door.
9. Close the front cover.
10. Dispose of the tubing according to your institution’s protocol.

Testing for Leaks


1. To ensure that the tubing has been properly reinstalled, perform the Leak Test.
Refer to Performing the Leak Test‚ page 6-37.
2. Select Return > Analyze > Yes.

Yearly Maintenance
Yearly maintenance includes the following tasks:
• Replacing the measurement module tubing and pressure sensor bubbler
• Replacing the CO-ox tubing
• Replacing the reagent manifold
• Replacing the AutomaticQC manifold
• Replacing the air filters

02087462 Rev. V
5-12 Rapidlab 1200 Operator’s Guide: Maintenance

Replacing the Measurement Module Tubing


You need a tubing kit for this task.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Select Status > Diagnostics > Cartridges.


2. Select Eject R Cartridge.
3. Lift the door on the measurement module.
Refer to Preparing for Maintenance Procedures‚ page 5-1.
4. Replace the pinch valve tubing.
Perform steps 4 and 5 of Replacing the Pinch Valve Tubing‚ page 5-10.
5. Replace the waste tubing between the pressure sensor bubbler and the reagent
manifold:
a. Disconnect the waste tubing from the pressure sensor bubbler and the reagent
manifold.

1 Pressure sensor bubbler


2 Waste tubing
3 Reagent manifold

Figure 5-3 Measurement Module–Rapidlab 1260 and 1265 systems

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-13

b. Connect the new tubing to the pressure sensor bubbler and to the reagent
manifold.
6. Dispose of the tubing according to your institution’s protocol.
7. Close the reagent cartridge door and then close the front cover.
8. If you have a Rapidlab 1245 or 1265 system and are replacing the CO-ox
tubing, continue with step 2 of Replacing the CO-ox Module Tubing‚
page 5-13.
9. Close the measurement module door.
10. Select No.
11. Select Return > Analyze > Yes.

Replacing the CO-ox Module Tubing


You need a CO-ox tubing kit for this task.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Select Status > Diagnostics > Cartridges.


2. Select Eject W Cartridge and remove the wash cartridge.
3. Lift the door to the measurement module.
Refer to Preparing for Maintenance Procedures‚ page 5-1.

02087462 Rev. V
5-14 Rapidlab 1200 Operator’s Guide: Maintenance

Replacing the CO-ox Sample Tubing


1. Disconnect the sample tubing from the connector on top of the sample chamber.

1 Sample chamber connector


2 Fluid detector
3 Measurement module connector

Figure 5-4 Measurement Module Sample Chamber

2. Rotate the gray wheel towards you, pull the tubing through the fluid detector, and
remove the tubing from the steel measurement module connector.
3. Push the new tubing through the fluid detector.
4. Connect the tubing to the steel measurement module connector and to the sample
chamber connector.
Use a clamp or tweezers to attach the tubing.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-15

Replacing the CO-ox Waste Tubing


1. Disconnect the CO-ox waste tubing from the pump tubing and the sample
chamber connector.

1 CO-ox pump tubing


2 CO-ox waste tubing
3 Sample chamber

Figure 5-5 CO-ox Module Tubing

2. Connect the CO-ox waste tubing to the CO-ox pump tubing and the sample
chamber connector.

02087462 Rev. V
5-16 Rapidlab 1200 Operator’s Guide: Maintenance

Replacing the CO-ox Pump Tubing


1. Disconnect the CO-ox pump tubing from the CO-ox waste tubing.

1 Roller cage
2 Platen
3 Lower tubing cuff
4 Reagent manifold tubing

Figure 5-6 CO-ox Module and Reagent Manifold

2. Disconnect the CO-ox pump tubing from the reagent manifold tubing at the fitting.
3. Do not disconnect the reagent manifold tubing from the reagent manifold.
4. Grasp the lower tubing cuff and pull the tubing away from the platen and the roller
cage.
5. Place the lower tubing cuff of the new tubing under the lower side of the platen, press
the tubing around the outside of the rollers, and turn the roller cage clockwise until the
tubing rests on the rollers.
6. Connect the tubing to the waste tubing and the reagent manifold tubing.

Completing CO-ox Maintenance


1. Close the front cover.
2. Reinstall the wash cartridge.
3. Dispose of the tubing according to your institution’s protocol.
4. Select Return.
5. Continue performing yearly maintenance or perform a full calibration.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-17

Replacing the Reagent Manifold


You need a reagent manifold for this task.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Select Status > Diagnostics > Cartridges.


2. Select Eject Both Cartridges, remove the cartridges, and set them aside.
3. Remove the reagent manifold:
a. Lift the front cover.
Refer to Preparing for Maintenance Procedures‚ page 5-1.
b. Disconnect the waste tubing from the reagent manifold.
c. For Rapidlab 1245 and 1265 systems, disconnect the reagent manifold
tubing from the CO-ox pump tubing at the fitting.
Do not disconnect the reagent manifold tubing from the reagent manifold.

1 Fitting
2 Reagent manifold tubing (Rapidlab 1245 and 1265 systems)
3 Waste tubing

Figure 5-7 Sample Chamber and Reagent Manifold

02087462 Rev. V
5-18 Rapidlab 1200 Operator’s Guide: Maintenance

d. Squeeze the finger snaps on the reagent manifold and then remove the manifold
by sliding it down and away from the sample connector.

1 Finger snaps

Figure 5-8 Reagent Manifold Finger Snaps

e. Dispose of the manifold according to your institution’s protocol.


4. Install the new reagent manifold:
a. Snap the new reagent manifold in place.
NOTE: When you are installing the tubing, avoid pinching or bending the tubing.
b. Connect the waste tubing.
c. For Rapidlab 1245 and 1265 systems, connect the reagent manifold tubing to the
CO-ox pump tubing at the fitting.

Completing Reagent Manifold Maintenance


1. Close the front cover.
2. Reinstall the reagent and wash cartridges.
3. Select Return.
4. Verify system performance:
a. Perform a 2-point calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
b. Analyze a minimum of 2 levels of quality control material.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-19

Replacing the AutomaticQC Manifold


You need an AutomaticQC manifold for this task.
1. Press down on the left side of the AutomaticQC cartridge connector and slide
the connector to the right.
2. Select Continue.
3. Select Diagnostics > Cartridges.
4. Select Eject R Cartridge, remove the reagent cartridge, and set it aside.
5. Lift the front cover.
Refer to Preparing for Maintenance Procedures‚ page 5-1.
6. Remove the AutomaticQC manifold:
a. Pull the connector port cover towards you.

1 Connector port cover


2 Cartridge connector
3 Pins

Figure 5-9 Connector Port and Cover

b. Push down on the pins on the manifold and pull the manifold and
connector port away.
7. Install the new AutomaticQC manifold:
a. Insert the bottom clip into the opening on the system.

02087462 Rev. V
5-20 Rapidlab 1200 Operator’s Guide: Maintenance

b. Align the tube loop that is on the back of the manifold with the groove in the
system.

1 Bottom clip

Figure 5-10 AutomaticQC Manifold–Back View

c. Insert the top clips into the holes and release the clips to lock them in place.
d. Insert the connector port into the indentation in the system wall and replace the
connector port cover.
8. Slide the cartridge connector to the left.

Completing AutomaticQC Manifold Maintenance


1. Close the front cover.
2. Reinstall the reagent cartridge.
3. Select Return.
4. Verify system performance:
a. Perform a 2-point calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
b. Analyze a minimum of 2 levels of quality control material.
5. Dispose of the manifold and connector port according to your institution’s protocol.

Replacing the Air Filters


You need 2 air filters for this task.
1. Select Status > Maintenance > Replacing the Air Filter.
2. Select Continue.
3. Follow the instructions in the video.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-21

Cleaning Procedures
This section provides procedures for performing as needed cleaning.

Cleaning and Disinfecting the Screen


Use a lint-free cloth to clean the screen. Do not use a spray bottle to spray the
bleach solution on the screen.
You need the following materials for this task:
• Lint-free cloth
• 5% bleach solution

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Moisten the cloth with the bleach solution so that the cloth is wet but not
dripping.
2. Select Status > Maintenance > Cleaning the Screen.
3. To start the procedure, select Continue.
The cleaning screen is displayed for 20 seconds and allows you to wipe the
screen without activating any buttons.
4. Wipe the screen with the wet cloth.
5. Allow the screen to air dry.
After 20 seconds, the system returns to the Maintenance screen.
6. Dispose of the bleach solution according to your institution’s protocol.

02087462 Rev. V
5-22 Rapidlab 1200 Operator’s Guide: Maintenance

Cleaning the Sample Path


Use this procedure to clean the sample path with bleach.
You need the following materials for this task:
• 10% bleach solution
• syringe
• lint-free tissue or swabs
• deproteinizer
• test/blank reference sensor (TB5)
• test/blank Glucose sensor (TB4)
• test/blank Lactate sensor (TB4)

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not expose the reference sensor to bleach. Replace the reference
sensor with the test/blank reference sensor (TB5) before cleaning.

CAUTION: Do not expose the glucose and lactate biosensors to bleach,


conditioner, or deproteinizer. Replace the biosensors with the test/blank sensors
(TB4) before conditioning the sensors or deproteinizing the sample path. Reinstall
the biosensors within 2 hours.

CAUTION: Do not use alcohol to perform this procedure. Alcohol can damage the
sensors.

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

1. Select Status > Maintenance > Deproteinizing the Sample Path.


2. To start the procedure, select Continue.
3. Replace the reference sensor and the biosensors with the test/blank sensors:
a. Lift the door to the measurement module.
Refer to Preparing for Maintenance Procedures‚ page 5-1.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-23

b. Push the spring-loaded latch to the right, grasp the tab on the reference
sensor, and pull the reference sensor up and out.

1 Reference sensor
2 Spring-loaded latch

Figure 5-11 Measurement Module

c. Align the top of the test/blank reference sensor (TB5) with the sensor
contact and snap the sensor into place.
4. If you have a Rapidlab 1260 or 1265 system, replace the Glucose and Lactate
biosensors with the test/blank Glucose Lactate (TB4) sensors.
Refer to step 3.
5. Close the measurement module door and then close the front cover.
6. Aspirate the deproteinizer:
a. Invert the deproteinizer vial several times to mix the deproteinizer
solution.
b. Draw the deproteinizer into a syringe and insert the syringe into the
sample port.
c. Select Continue.
d. When prompted, remove the syringe and select Continue.
The system displays a message prompting you to condition the sensors.

02087462 Rev. V
5-24 Rapidlab 1200 Operator’s Guide: Maintenance

7. Perform the cleaning cycle:


a. Select Yes.
b. Draw the 10% bleach solution into a syringe and insert the syringe into the sample
port.
c. Select Continue.
d. When prompted, remove the syringe and select Continue.
Do not replace the test/blank sensors at this time.
8. Select Continue.
9. Select Wash Cycle.

Reinstalling the Reference Sensor and Biosensors


1. Lift the front cover and then lift the measurement module door.
2. Push the spring-loaded latch to the right.
3. Grasp the tab on the test/blank reference sensor and pull the sensor up and out.
4. Align the top of the reference sensor with the sensor contact.
5. Snap the sensor into place.
6. If you have a Rapidlab 1260 or 1265 system, replace the test/blank sensors with the
Glucose and Lactate sensors.

Completing the Sample Path Maintenance


1. Use the sensor names on the contact assembly to verify that the sensors are installed in
the correct order.
2. Press the tab on the spring-loaded latch to release the latch.
3. Close the measurement module door and then close the front cover.
4. Wait 30 minutes for the sensors to warm up.
5. Select Return > Analyze > Yes.
6. Analyze a minimum of 2 levels of quality control material.
7. Dispose of the bleach solution according to your institution’s protocol.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-25

Cleaning the CO-ox Roller Cage


Use this procedure to clean the roller cages of the CO-ox pump.
You need the following materials for this task:
• Lint-free tissue and swabs
• 10% bleach solution
• Water

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Select Status > Maintenance.


2. Lift the front cover.
Refer to Preparing for Maintenance Procedures‚ page 5-1.
3. Disconnect the reagent manifold tubing from the CO-ox pump tubing at the
fitting.

1 Fitting
2 Reagent manifold tubing

Figure 5-12 CO-ox Pump Tubing to Reagent Manifold

4. Grasp the lower tubing cuff and gently pull it away from the platen.

02087462 Rev. V
5-26 Rapidlab 1200 Operator’s Guide: Maintenance

5. While holding the lower side of the tubing, turn the roller cage clockwise and gently
pull the tubing away from the platen and the roller cage.

1 Platen
2 Roller cage
3 Lower tubing cuff

Figure 5-13 CO-ox Module

6. Gently pull the roller cage straight off its shaft.

Cleaning the Roller Cage


1. Clean the rollers and the roller cage shaft using lint-free tissues moistened with the
bleach solution.
2. Clean the interior surface of the roller cage using a lint-free swab moistened with the
bleach solution.
3. Rinse the rollers, the cage, and the shaft with water.
4. Dry the roller cage thoroughly and ensure that the rollers turn freely.

Reinstalling the Roller Cage


1. Replace the roller cage onto the shaft.
2. Press the roller cage down and turn it clockwise until the cage snaps into place.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-27

Reconnecting the CO-ox Tubing


1. Place the lower tubing cuff under the lower side of the platen.
NOTE: Do not stretch the tubing.
2. Press the tubing around the outside of the rollers.
3. Place the upper tubing cuff onto the upper side of the platen.
4. Turn the roller cage clockwise to gently work the new tubing between the
platen and the roller cage.
5. Connect the CO-ox pump tubing to the reagent manifold tubing.
6. Select Return.
7. Perform a full calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
8. Dispose of the bleach solution according to your institution’s protocol.

Cleaning the Waste Assembly


Use this procedure to clean the waste assembly when you are replacing an expired
or depleted AutomaticQC cartridge. Removing the AutomaticQC cartridge
invalidates the cartridge.
You need the following materials for this task:
• New AutomaticQC cartridge
• Lint-free cloth
• 10% bleach solution
• Waste bottle

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Remove the expired or depleted AutomaticQC cartridge:


a. Select Status > AutomaticQC Cartridge > Replace > Yes.
b. Follow the instructions in the video.
2. Dispose of the AutomaticQC cartridge according to your institution’s
protocol.
3. Remove the waste bottle and dispose of it according to your institution’s
protocol.

02087462 Rev. V
5-28 Rapidlab 1200 Operator’s Guide: Maintenance

4. Remove the waste assembly:


a. Lift the orange lever up.

1 Orange lever

Figure 5-14 Waste Assembly

b. Slide the waste assembly to the right.


5. Clean the waste assembly with the 10% bleach solution.
6. Replace the waste assembly and push the orange lever down.
7. Place the new waste bottle in the waste assembly.
8. Install a new AutomaticQC cartridge.
9. Select Return.
10. Dispose of the bleach solution according to your institution’s protocol.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-29

Maintaining the Sensors


Performing regular maintenance on the sensors is important to the life of the
sensors. This section contains the following information:
• Replacing the sensors
• Performing reference sensor maintenance
• Refilling the sensors

Replacing the Sensors


You need the following materials for this task:
• Appropriate sensor
• Appropriate sensor fill solution
• Reference sensor replacement kit
• Hex tool
• Lint-free tissue

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

Preparing the Sensors


• Equilibrate new Glucose and Lactate biosensors at room temperature
(18° to 25°C) for at least 1 hour before installing.
• Keep the biosensors in their foil packages while they are equilibrating.

02087462 Rev. V
5-30 Rapidlab 1200 Operator’s Guide: Maintenance

Removing the Sensors


1. Select Status > Maintenance > Performing Sensor Maintenance.
2. To start the procedure, select Continue.
3. Remove the sensor:
a. Lift the door to the Measurement module.
Refer to Preparing for Maintenance Procedures‚ page 5-1.
b. Push the spring-loaded latch to the right.

1 Spring-loaded latch

Figure 5-15 Rapidlab 1260 or 1265 Measurement Module

c. Grasp the tab on the sensor and pull the sensor up and out.
d. Discard the sensor according to your institution’s policy.
4. If you are replacing a measurement sensor, refer to Performing Measurement Sensor
Maintenance‚ page 5-40
5. If you are replacing the reference sensor, fill the internal electrode compartment.
Refer to Filling the Reference Sensor Cassette‚ page 5-36.
6. If you are replacing the reference sensor or measurement sensors, install the internal
electrode into the internal electrode compartment and screw the electrode into place.
7. Clean and inspect the sensor:
a. Tap the front face of the sensor with your knuckle to remove any bubbles.
b. Wipe any excess fill solution from the exterior of the sensor using a lint-free
tissue.
c. Ensure that the O-ring is in place:
• Reference sensor has an O-ring on both sides of the sensor.
• All other sensors have an O-ring on the left side of the sensor.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-31

Installing the Sensor


1. Align the top of the sensor with the sensor contact.
2. Use the sensor names on the contact assembly to verify that the sensors are
installed in the correct order.
3. Snap the sensor into place.
4. Press the tab on the spring-loaded latch down to release the latch.
5. Close the measurement module door and then close the front cover.
6. Select Yes > Continue > Wash Cycle.

Verifying Sensor Performance


If you replaced... Then...
sample ground/temperature sensor, check the sample path temperature:
a. Select Status > Diagnostics >
Temperature.
b. Check the printout for the sample
temperature reading.
c. Select Return twice.
reference sensor or measurement sensors, wait 30 minutes for the sensors to warm
up.
Glucose or Lactate biosensors, a. Select Calibrate > 2-point.
The calibrations start hydrating the
biosensors.
b. Allow the biosensors to warm up for
at least 30 minutes.
1. Select Return > Analyze > Yes.
2. Inspect the sensor for bubbles.
As the temperature of the sensor rises to 37°C, gas driven from the solution
causes bubbles.
3. If bubbles are in the sensor, remove the bubbles:
a. Select Status > Maintenance > Performing Sensor Maintenance.
b. To start the procedure, select Continue.
c. Remove the sensor.
d. Tap the front face of the sensor with your knuckle to remove bubbles.
e. Reinstall the sensor.
f. Select Yes > Continue > Return.
g. Select Analyze > Yes.
h. Wait 15 to 30 minutes for the sensor to warm up.

02087462 Rev. V
5-32 Rapidlab 1200 Operator’s Guide: Maintenance

4. If you replaced the pH or Na+ sensors, condition the sensors.


Refer to Conditioning the Sensors‚ page 5-6.
5. Analyze a minimum of 2 levels of quality control material.

Filling the Sensor


You need the following materials for this task:
• pH or Na+, K+, Cl¯, and Ca++ sensor
• appropriate sensor fill solution kit containing a fill solution vial and a cylinder that
contains a needle
• lint-free tissue or cloth

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

NOTE: D2, D3, and D4 error codes may result when bubbles are detected in the fill
solution. This procedure is designed to minimize the occurence of bubbles in the fill
solution.
NOTE: Bubbles on the surface of the fill solution are acceptable. Only bubbles in the fill
solution result in D2, D3, and D4 error codes.
NOTE: Do not shake the vial containing the fill solution. This can create bubbles in the
fill solution.
1. Remove the sensor.
Refer to Replacing the Sensors‚ page 5-29.
If the sensor is new, go to step 4.
2. Unscrew the internal electrode and place the electrode and sensor assembly on a
lint-free tissue.
3. Empty the fill solution from the sensor.
Dispose of the fill solution according to your institution’s protocol.
4. Attach the needle to the fill solution vial.
a. Twist off the top of the vial that contains the fill solution.
b. Slide the smaller, open-end of the needle cylinder onto the fill solution vial.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-33

c. Remove the cylinder, so the needle remains attached to the vial.


5. Rinse the sensor.
a. Insert the needle, attached to the vial, into the sensor.
b. Gently squeeze the fill solution vial until the sensor is full of solution.
c. Eject the fill solution so the sensor is empty.
Dispose of the fill solution according to your institution’s protocol.
6. Fill the sensor.
a. Squeeze the fill solution vial until a drop is emitted or remains at the tip of
the needle.
This helps minimize the occurrence of bubbles once the needle is inserted
in the sensor.
b. Insert the needle, attached to the fill solution vial, until the needle is near
the bottom of the sensor.
For these sensors... Add...
pH until sensor is almost full but with a small space (1 mm) at
Na+, K+, Cl¯, and Ca++ the top

c. Slowly raise the needle as you gently squeeze the fill solution vial, until
the sensor is nearly full.

CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.
7. Install the internal reference electrode into the internal electrode compartment
and screw the electrode into place.
8. Inspect the sensor for bubbles.
As the temperature of the sensor rises to 37°C, gas driven from the solution
causes bubbles.
9. Clean and inspect the sensor:
a. Tap the front face of the sensor with your knuckle to remove any bubbles.
If bubbles reamain in the sensor, see Step 3 of Verifying Sensor
Performance‚ page 5-31.
b. Wipe any excess fill solution from the exterior of the sensor using a
lint-free tissue.
10. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
11. Verify sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.

02087462 Rev. V
5-34 Rapidlab 1200 Operator’s Guide: Maintenance

Performing Reference Sensor Maintenance


The Reference sensor requires regular cleaning to maintain performance.

Cleaning and Inspecting the Reference Sensor


You need the following materials for this task:
• Water
• Lint-free swab

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

1. Remove the Reference sensor.


Refer to Removing the Sensors‚ page 5-30.

1 Reference sensor
2 Spring-loaded latch

Figure 5-16 Measurement Module

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-35

2. Check the sensor for bubbles at the electrode tip and between the electrode
compartment and the KCl reservoir.

1 KCl reservoir
2 Electrode compartment join to the KCl reservoir
3 Electrode tip
4 O-rings

Figure 5-17 KCl Reservoir

NOTE: The fill solution can become slightly pink as a result of analyzing QC
and AutomaticQC materials. A pink color that becomes very dark over a
12-hour period indicates a pending failure of the reference sensor. Replace the
reference sensor or the reference sensor cassette.
3. Tap the front face of the sensor with your knuckle to remove any bubbles.
4. Remove any salt deposits on the reference sensor using a lint-free swab
moistened with water.
5. Dry the sensor thoroughly.
6. Ensure that the O-rings are in place on both sides of the sensor.
7. Replace any O-ring that is worn or damaged.
8. Clean the O-ring area on the spring-loaded latch using a lint-free swab
moistened with water.
9. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
10. Verify the sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.

02087462 Rev. V
5-36 Rapidlab 1200 Operator’s Guide: Maintenance

Filling the Reference Sensor Cassette


If you do not have a new reference sensor cassette, refill the reference sensor instead.
You need the following materials for this task:
• Reference electrode refill kit
• Reference electrode internal replacement kit
• Hex tool
• Lint-free tissue

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.
1. Remove the sensor.
Refer to Removing the Sensors‚ page 5-30.
2. Remove the internal reference electrode:
a. Remove the internal reference electrode using the hex tool.

1 Internal electrode
2 Cassette
3 Internal electrode compartment

Figure 5-18 Reference Sensor Cassette

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-37

b. Stand the internal electrode on its cap to drain it.


3. Fill the internal electrode compartment of the new sensor with KCl fill
solution:
a. Insert the tip of the KCl fill solution container into the internal electrode
compartment.

1 KCl fill solution


2 KCl reservoir
3 Internal electrode compartment

Figure 5-19 Reference Sensor Cassette and KCl Fill Solution

b. Fill the internal electrode compartment until the KCl fill solution enters
the KCl reservoir.

CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.

4. Install the internal electrode into the internal electrode compartment and
screw the electrode into place using the hex tool.

02087462 Rev. V
5-38 Rapidlab 1200 Operator’s Guide: Maintenance

5. Fill the KCl reservoir with KCl fill solution:


a. Remove the reservoir cap using the hex tool and set the cap aside.
b. Partially fill the KCl reservoir.
c. Tap the front face of the sensor with your knuckle to remove any bubbles.
d. Continue filling the reservoir with KCl fill solution to the fill line.

CAUTION: Do not overtighten the reservoir cap. Overtightening can deform the
gasket and cause leaks.

6. Hand tighten the reservoir cap.


7. Clean and inspect the sensor:
a. Tap the front face of the sensor with your knuckle to remove any bubbles.
b. Wipe any excess fill solution from the exterior of the sensor using a lint-free
tissue.
c. Ensure that the O-rings are in place.
8. Install the Reference sensor.
Refer to Installing the Sensor‚ page 5-31.
9. Verify sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-39

Maintaining the Internal Reference Electrode


1. Remove the internal reference electrode using the hex tool.

1 Internal electrode
2 Cassette
3 Internal electrode compartment

Figure 5-20 Reference Sensor Casette

2. If you are replacing the internal reference electrode, dispose of the electrode
according to your institution’s protocol.
3. If you are replacing the internal reference electrode, rinse the electrode
compartment with KCl fill solution:
a. Empty the fill solution from the sensor.
b. Rinse the internal electrode compartment with 3 drops of KCl fill
solution.
c. Empty those drops of fill solution from the sensor.
4. Fill the internal electrode compartment with KCl solution.
Refer to Filling the Reference Sensor Cassette‚ page 5-36.
5. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
6. Verify sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.

02087462 Rev. V
5-40 Rapidlab 1200 Operator’s Guide: Maintenance

Performing Measurement Sensor Maintenance


You need the following materials for this task:
• appropriate sensor fill solution kit
• lint-free tissue
The following table lists the fill solution to use for each sensor:
Sensor Fill Solution
pH pH
Na+, K+, Cl¯, Ca++ Na+, K+, Cl¯, Ca++

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.
1. Remove the sensor.
Refer to Replacing the Sensors‚ page 5-29.
2. Unscrew the internal electrode, and place the electrode and the sensor assembly on a
lint-free tissue.
3. Empty and rinse the sensor
a. Empty the fill solution from the sensor.
b. Rinse the sensor:
For this sensor... Rinse...
pH, the internal electrode compartment with 3 drops of pH fill
solution.
Na+, K+, Cl¯, and Ca++, the internal electrode compartment with 3 drops of the
Na+, K+, Cl¯, and Ca++ fill solution.
c. Empty the drops of fill solution from the sensor.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-41

4. Add fill solution:


For these sensors... Add...
pH K+, Cl¯, and Ca++ sensors almost full but with a small
+ + ++ space (1 mm)at the top
Na , K , Cl¯, and Ca

CAUTION: Do not touch the internal electrode wire. The wire is fragile and is
easily damaged.

5. Install the internal reference electrode into the internal electrode compartment
and screw the electrode into place.
6. Clean and inspect the sensor:
a. Tap the front face of the sensor with your knuckle to remove any bubbles.
b. Wipe any excess fill solution from the exterior of the sensor using a
lint-free tissue.
c. Verify that the O-ring is in place on the left side of the sensor.
Replace the O-ring if it is worn or damaged.
7. Reinstall the sensor.
Refer to Installing the Sensor‚ page 5-31.
8. Verify sensor performance.
Refer to Verifying Sensor Performance‚ page 5-31.

02087462 Rev. V
5-42 Rapidlab 1200 Operator’s Guide: Maintenance

Replacing System Components


This section contains procedures for replacing system components.

Replacing the Printer Paper


Replace the printer paper when a red stripe is displayed on the edge of the paper.
You need printer paper for this task.
1. Select Status > Maintenance > Replacing the Printer Paper.
2. To start the procedure, select Continue.

CAUTION: Do not pull the torn paper back through the printer. This can damage
the printing mechanism.
3. Follow the instructions in the video.

Replacing the Sample Port


Use this procedure to replace the sample port. Replace the sample port if you detect a
problem, or if the system prompts you as a result of obstructions such as fibrin clots.
You need a sample port for this task.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Select Status > Maintenance > Replace Sample Port.


2. To start the procedure, select Continue.
3. Follow the instructions in the video.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-43

Replacing the CO-ox Lamp

WARNING: Do not touch the lamp until it has been off for at least 5 minutes.
Waiting for at least 5 minutes allows sufficient time for the lamp to cool.

You need a CO-ox lamp for this task.


1. Ensure that the system is not performing any analysis.

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.

WARNING: To prevent damage to the hard drive and permanent loss of data, use
this procedure to shut down the system.

2. Shutdown the system:


a. Select Status > Shutdown > Yes.
b. When prompted, turn the power switch off.
The power switch is on the back panel of the system.
3. Move the system so that you are able to work directly behind the system.
4. For ease of access, prop the back of the system up by about 3/4 inch (1.9 cm).
When you prop up the back of the system, the back cover can lay flat when
you open it.

02087462 Rev. V
5-44 Rapidlab 1200 Operator’s Guide: Maintenance

5. Open the back cover.

1 Electrical connector
2 Lamp base
3 Back cover

Figure 5-21 Rapidlab 1200 System–back view

6. Remove the lamp:


a. Stand directly behind the system and grasp the base of the lamp.
b. Pull the lamp out straight toward you.
c. Grasp the electrical connector and pull it straight back to disconnect it.
Pull steadily with increasing force until it comes free.
7. Dispose of the lamp according to your institution’s protocol.

CAUTION: Avoid touching the new CO-ox lamp with your fingers. Touching the
glass may cause the lamp to prematurely deteriorate.
8. Install a new lamp:
a. Push the new lamp into the lamp receptacle area.
The lamp has a key that you must line up with the key hole in the side of the
receptacle area.
b. Push the electrical connector onto the electrical fitting.
9. Close the back cover.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-45

10. Start up the system:


a. Turn the power switch on.
b. At the interface screen, use the numeric buttons to enter your password.
c. Select Continue.

Replacing the CO-ox Roller Cage


Use this procedure to replace the roller cage of the CO-ox pump.
You need the following materials for this task:
• Lint-free tissue and swabs
• Roller cage
• Water

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

Removing the Roller Cage


1. Select Status > Maintenance.
2. Lift the front cover.
Refer to Preparing for Maintenance Procedures‚ page 5-1.
3. Disconnect the reagent manifold tubing from the CO-ox pump tubing at the
fitting.

1 Fitting
2 Reagent manifold tubing

Figure 5-22 CO-ox Module and Reagent Manifold

02087462 Rev. V
5-46 Rapidlab 1200 Operator’s Guide: Maintenance

4. Grasp the lower tubing cuff and gently pull it away from the platen.
5. While holding the lower side of the tubing, turn the roller cage clockwise and gently
pull the tubing away from the platen and the roller cage.

1 Platen
2 Roller cage
3 Lower tubing cuff

Figure 5-23 CO-ox Module

6. Gently pull the roller cage straight off its shaft.


7. Dispose of the roller cage according to your institution’s protocol.

Cleaning the Roller Cage Shaft


Clean the roller cage shaft using lint-free tissues moistened with water and then
thoroughly dry the shaft.

Installing the New Roller Cage


1. Place the new roller cage on the shaft.
2. Press the roller cage down and turn the cage clockwise until the cage snaps into place.
3. Place the lower tubing cuff under the lower side of the platen.
NOTE: Do not stretch the tubing.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-47

4. Press the tubing around the outside of the rollers.


5. Place the upper tubing cuff onto the upper side of the platen.
6. Turn the roller cage clockwise to gently work the new tubing between the
platen and the roller cage.
7. Connect the CO-ox pump tubing to the reagent manifold tubing.
8. Close the front cover.
9. Select Return.
10. Perform a full calibration.
For information about performing calibrations, refer to Recalling Calibration
Results‚ page 3-4.

Replacing the System Fuses


Replace both fuses if 1 or both of the fuses are blown.
Before replacing the fuses, verify that power is being supplied to the system:
• The power switch on the back panel is turned on.
• The power cord is firmly connected to the system and to the electrical outlet.
• The electrical outlet is working.
You need the following materials for this task:
• Two fuses of the appropriate rating
• Screwdriver
The Rapidlab 1200 systems use the following fuses for the voltages shown:
Voltage Fuse Rating Fuse Type
100–240V 1.6A Slo Blo 5 x 20 mm

WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.

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.

02087462 Rev. V
5-48 Rapidlab 1200 Operator’s Guide: Maintenance

1. Select Status > Shutdown > Yes.


The system displays the Shutdown screen and stops all fluidic sequences so that no
damage to the cartridges can occur.
2. Turn the power off and disconnect the power cord from the electrical outlet.
3. Open the fuse holder:
a. Insert a small flat-head screwdriver in the tabs on each side of the fuse holder.
b. Pull the fuse holder out from the compartment as far as possible.

1 Fuse holder

Figure 5-24 Fuse Holder

4. Remove the old fuses and dispose of them according to your institution’s protocol.
5. Install new fuses.
6. Slide the fuse holder into the fuse compartment.
7. Restore power:
a. Reconnect the power cord to the system.
b. Reconnect the power cord to the electrical outlet.
c. Turn the power on.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-49

Relocating the System


Use this procedure to move the system for use in another area.

WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.

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.

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


mixture with air, O2, or nitrous oxide. The risk of explosion exists in a potentially
explosive environment. Refer to Protecting Yourself from Electrical Hazards‚
page A-3 for recommended precautions when working around electricity.

1. Select Status > Shutdown.


2. When the system displays the Shutdown screen, turn the power off and
disconnect the power cord from the electrical outlet.
3. Disinfect the exterior surfaces of the system.
Refer to Cleaning and Disinfecting the Exterior Surfaces‚ page 5-2.
4. Move the system to its new location.
5. To restore power to the system, connect the power cord to the electrical outlet.
6. Turn the power on.

02087462 Rev. V
5-50 Rapidlab 1200 Operator’s Guide: Maintenance

Shipping or Storing the System

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.

Shipping or storing the system involves 5 basic steps:


1. Clean the sample path with bleach.
2. Remove the cartridges.
3. Clean and dry the tubing.
4. Remove and store the sensors.
5. Remove peripherals and disinfect the exterior surfaces.
When you are ready to dispose of the system, observe federal, state, and local codes or
requirements for disposal or recycling. Use the following procedures to prepare the system
for long term storage, shipping to another location for repair, or for disposal.

Cleaning the Sample Path


Refer to Cleaning the Sample Path‚ page 5-22.

Removing the Cartridges


1. Select Status > Diagnostics > Cartridges.
2. If an AutomaticQC cartridge is installed, remove and dispose of it according to your
institution’s protocol:
a. Slide the connector on the AutomaticQC cartridge to the right.
b. Select Eject AQC Cartridge.
3. Select Eject Both Cartridges, remove the reagent and wash cartridges, and dispose of
them according to your institution’s protocol.
4. In Setup, turn the AutomaticQC option off:
a. Select Setup > QC Options > Unscheduled QC.
b. Select Save.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-51

Cleaning and Drying the Tubing


Ensure that you follow these instructions using at least the minimum volumes of
fluid and air described in these procedures.

Flushing the Tubing for the RCx Reagent


1. Connect a piece of tubing to a syringe.
2. Connect the syringe tubing to the connector for the RCx reagent.

1 Water collection area


2 RCx reagent Connector

Figure 5-25 Reagent Manifold

3. Flush with a minimum of 3 mL water.


4. Flush with a minimum of 12 mL air.
5. Collect the water in an absorbent swab or equivalent.

02087462 Rev. V
5-52 Rapidlab 1200 Operator’s Guide: Maintenance

Flushing the Upper Connector


1. Connect the syringe tubing to the upper connector for the wash reagent.

1 Water collection area


2 Upper connector

Figure 5-26 Reagent Manifold

2. Flush with a minimum of 3 mL water.


3. Flush with a minimum of 12 mL air.
4. Collect the water in an absorbent swab or equivalent.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-53

Flushing the Lower Connector


1. Connect the syringe tubing to the lower connector for the wash reagent.
2. Flush with a minimum of 3 mL water.
3. Flush with a minimum of 12 mL air.
4. Capture the water in an absorbent swab or equivalent.

1 Water collection area


2 Lower connector

Figure 5-27 Reagent Manifold Lower Connector

02087462 Rev. V
5-54 Rapidlab 1200 Operator’s Guide: Maintenance

Flushing the Tubing for the Samples


1. Connect the syringe tubing to the connector for samples.
2. Flush the sample tubing with a minimum of 3 mL water.
3. Flush the sample tubing with a minimum of 12 mL air.
4. Collect the water in an absorbent swab or equivalent.

1 Water collection area


2 Sample connector

Figure 5-28 Sample Tubing

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-55

Flushing the Tubing for the Measurement Module


1. Disconnect the tubing from the left side of the pressure sensor bubbler.
2. Connect the syringe tubing to the pressure sensor bubbler.
3. Flush the measurement module tubing with a minimum of 3 mL water.
4. Flush the measurement module tubing with a minimum of 12 mL air.
5. Collect the water in an absorbent swab or equivalent.
6. Reconnect the tubing to the pressure sensor bubbler.

1 Pressure sensor bubbler


2 Disconnected tubing
3 Water collection area

Figure 5-29 Measurement Module Pressure Sensor Bubbler

02087462 Rev. V
5-56 Rapidlab 1200 Operator’s Guide: Maintenance

Flushing the Tubing for the Measurement Module Waste


1. Disconnect the tubing on the reagent manifold coming from the pressure sensor
bubbler.
2. Connect the syringe tubing to the connector on the reagent manifold.

1 Connector
2 Pressure sensor bubbler
3 Water collection area

Figure 5-30 Reagent Manifold Connector

3. Flush the tubing with a minimum of 3 mL of water.


4. Flush the tubing with a minimum of 12 mL air.
5. Collect the water in an absorbent swab or equivalent.
6. Reconnect the tubing to the reagent manifold.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-57

Flushing the Tubing for the AutomaticQC Module


1. Connect the syringe tubing to the AutomaticQC manifold.
2. Flush with a minimum of 3 mL water.

1 Water collection area


2 AutomaticQC manifold

Figure 5-31 AutomaticQC Tubing

3. Flush with a minimum of 12 mL air.


4. Collect the water in an absorbent swab or equivalent.
5. Disconnect the syringe tubing.

02087462 Rev. V
5-58 Rapidlab 1200 Operator’s Guide: Maintenance

Flushing the Reagent Manifold Tubing


This section applies to the Rapidlab 1245 and 1265 systems.
1. Disconnect the reagent manifold tubing from the CO-ox pump tubing.
2. Connect the syringe to the waste tubing.

1 Connector
2 Waste tubing
3 Water collection area

Figure 5-32 Reagent Manifold–Rapidlab 1245 and 1265 Systems

3. Flush the waste tubing with a minimum of 3 mL water.


4. Flush the waste tubing with a minimum of 12 mL air.
5. Collect the water in an absorbent swab or equivalent.
6. Reconnect the reagent manifold tubing from the CO-ox pump tubing.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-59

Flushing the CO-ox Pump Tubing


This section applies to the Rapidlab 1245 and 1265 systems.
1. Remove the CO-ox roller cage.
2. Disconnect the CO-ox sample tubing from the connector on the measurement
module.

1 Sample chamber connector


2 Fluid detector
3 Measurement module connector, collect the water here

Figure 5-33 CO-ox Sample Chamber Tubing

3. Flush the tubing with a minimum of 3 mL water.


4. Flush the tubing with a minimum of 12 mL air.
5. Collect the water in an absorbent swab or equivalent.
6. Reinstall the CO-ox roller cage.
7. Reconnect the CO-ox pump tubing and the CO-ox sample tubing.
8. Remove the CO-ox sample chamber and discard it according to your
institution’s protocol.
9. To exit Diagnostics, close the cartridge doors.
10. Select Return.

02087462 Rev. V
5-60 Rapidlab 1200 Operator’s Guide: Maintenance

Removing and Storing the Sensors


1. Select Status > Maintenance > Performing Sensor Maintenance.
2. To start the procedure, select Continue.
3. Remove the sensor:
a. Lift the front cover, push up the latches on the measurement module door, and
then lift the door.
b. Push the spring-loaded latch to the right.
c. Grasp the tab on the sensor and pull the sensor up and out.
4. Store each sensor in the original packaging.

Removing Peripherals and Disinfecting the Exterior


Surfaces
1. Remove the waste bottle and dispose of it according to your institution’s protocol.
2. Clean and disinfect the exterior surfaces.
Refer to Cleaning and Disinfecting the Exterior Surfaces‚ page 5-2.
3. Remove the roll of printer paper and remove any remaining paper from the printer by
turning the paper-advance knob clockwise.

Shutting Down and Packing the System


1. Select Status > Shutdown > Yes.
2. After the system displays the Shutdown screen, turn the power off and disconnect the
power cord from the electrical outlet and from the system.
3. If the optional barcode scanner is installed, disconnect the barcode scanner.
4. Pack the system in the original shipping carton.
If the original carton is no longer available, contact your local technical support
provider or distributor for a replacement shipping carton.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-61

Scheduling Maintenance Activities


The maintenance schedule displays the maintenance tasks that are currently
scheduled. The schedule displays a calendar week with the day and date at the top
of the schedule and the state of each task in the grid.
Task state Background Indicator
Overdue red [blank]
Due yellow solid circle
Not Due green [blank]
As Required green [blank]
Completed checkmark

You can navigate from week to week by using the right and left pointing arrows at
the top of the right panel. You can navigate within the schedule grid, moving
down the task list or back and forth through the days of the week by using the four
directional arrows at the middle of the right panel. The currently selected cell has
a white background.

Performing Scheduled Maintenance Tasks


After performing a maintenance task, you must mark it Complete on the schedule.
Some tasks, like Deproteinizing the Sample Path, automatically mark the schedule
as Complete but you should check for the Complete mark after completing each
Maintenance task.
If you complete the task within the grace period, the task is automatically
scheduled for its next due date.
• If you complete a task before the grace period, the system does not change the
schedule and you are prompted to perform that task again during its regularly
scheduled time.
• If you complete a task after the grace period, the next task is scheduled for the
scheduled time period after you actually perform the task.
To record a maintenance task, perform the following steps:
1. Select Status > Maintenance > Schedule.
2. Select the maintenance task you want to record as completed.
3. Select Completed.

02087462 Rev. V
5-62 Rapidlab 1200 Operator’s Guide: Maintenance

Maintenance Task Grace Period


The Grace Period is a defined amount time before or after the scheduled due date. When
you perform a maintenance task within this grace period and mark the task as complete,
the system automatically sets the next date for the task. The grace periods supported for
the maintenance tasks are shown in the following table:
Frequency of Task Grace Period
Daily None
Twice Weekly + 1 day
Weekly + 1 day
Every Two Weeks + 1 day
Monthly + 1 day
Every Two Months + 3 days
Quarterly + 3 days
Twice Yearly + 3 days
Yearly + 3 days
As Required None

Marking Maintenance Tasks Complete


NOTE: You can only mark tasks Completed on the current date for either of the previous
two days. When you select any other day in the calendar grid, the system disables the
Completed button.
1. Select Status > Maintenance > Schedule.
2. Select the maintenance task you completed.
3. Select Completed.

Undoing the Completed Marker


When you select the Completed button to mark a task as completed, it becomes an Undo
button. If you marked the task incorrectly, you can now undo the mark.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Maintenance 5-63

Viewing Maintenance Task Details


The following information is available on the Details screen:
• Description
• Next Due
• Last Performed
This area is blank if the selected task is “As required.”
• Frequency
To view maintenance task details, perform the following steps.
1. Select Status > Maintenance > Schedule.
2. Select the maintenance task you want to view.
3. Select Details.

Change System Time for Daylight Saving Time


NOTE: Setting the date on the system clock back (as for daylight saving time)
eliminates all maintenance completions performed within that hour.
For instructions on setting system time, refer to Setting up the Date and Time‚
page 8-20.

02087462 Rev. V
5-64 Rapidlab 1200 Operator’s Guide: Maintenance

02087462 Rev. V
6 Troubleshooting

This section contains procedural information for system issues:


• troubleshooting system problems
• removing obstructions
• understanding and resolving D codes
• understanding and resolving system messages

Troubleshooting Failed or Missed QC Analysis


Use this section to help determine causes and corrective actions for failed QC
analysis and for QC analysis not performed as scheduled. Perform the steps in the
solution, in the order listed, until the problem is resolved.

Troubleshooting the Yellow Parameter Error


Probable
Error Cause Corrective Action
The parameter The parameter • Repeat QC Analysis.
is yellow with has failed QC • If the parameter fails analysis again (check the
a line through because the Results screen), perform a successful 2-point
it and QC is sensor has calibration.
displayed in drifted since • Repeat QC analysis.
the lower left the last • If the parameter fails analysis again, view the
corner. automatic events log for D codes and messages.
calibration.
Errors • Follow the storage and handling requirements
occurred provided with the control material.
during storage For AutomaticQC cartridges, ensure that the
or handling of cartridge was stored at a temperature between
the control 2° to 8°C. For recommendations to resolve
material. failed QC performed from an ampule, refer to
Troubleshooting the Ampule QC‚ page 6-3.
• If the parameter fails analysis again,
troubleshoot the affected sensor.

02087462 Rev. V
6-2 Rapidlab 1200 Operator’s Guide: Troubleshooting

Probable
Error Cause Corrective Action
Parameter Perform the following steps until the system is
failed ready for use:
AutomaticQC • Perform up to two 2-point calibrations.
analysis • If the parameter fails the 2-point calibrations,
because the view the events log for D codes and messages.
sensor or the
• Replace the sensor if necessary.
cartridge is not
working • If the parameter passed the 2-point
correctly. calibrations, perform AutomaticQC analysis
for the failed level of control.
• If the parameter fails AutomaticQC analysis,
analyze a QC sample for the failed level using
QC material from an ampule.
• If the parameter fails the ampule QC analysis,
review the events log for D codes and
messages.
• If the parameter passes the ampule QC
analysis, replace the AutomaticQC cartridge.
The target • Verify that the target ranges entered for the
ranges for one control are correct.
or more If you specify target ranges that are narrower
parameters are than those provided with the control,
too narrow. parameters may fail QC analysis.
• Analyze QC for the failed level.
Refer to Performing Unscheduled QC Sample
Analysis‚ page 4-4.
• If the results are within range, restore the
parameter.
Refer to Restoring Parameters‚ page 4-12.
• For AutomaticQC samples, analyze the failed
level.
Refer to Performing Unscheduled QC Sample
Analysis‚ page 4-4.
If the results are within range, the system
restores the parameter.
• If analysis fails again, review the events log for
D codes and messages.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-3

Troubleshooting the Purple Parameter Error


Probable
Error Cause Corrective Action
The parameter Required QC • Analyze all the currently scheduled controls.
is purple with a analysis was Refer to Performing Required QC Sample
line through it not performed Analysis‚ page 4-1.
and QC! is when • If the scheduled controls do not contain the
displayed in scheduled. necessary levels, analyze QC for the
the lower left appropriate levels.
corner. Refer to Performing Unscheduled QC Sample
Analysis‚ page 4-4.
• If the results are within range, turn the
parameter on.
Refer to Restoring Parameters‚ page 4-12.

Troubleshooting the Ampule QC


Use the following recommendations to help resolve issues with failed QC
performed from an ampule:
• Perform only one QC analysis for each ampule.
Performance claims are based on one QC analysis per ampule.
• Always use the Quick adapter when analyzing QC samples.
• Analyze the QC material immediately after opening the ampule.
Prolonged contact with the atmosphere affects pH, pCO2, and pO2 results.
• Ensure that the correct target ranges are defined in Setup.
• Store QC material at a constant temperature.
• Do not handle ampules excessively.
Variation in results may occur due to changes in temperature.
• Do not use expired QC materials.
• Do not analyze QC materials that contain bubbles.
• Use the correct level of QC material that is scheduled for analysis.

02087462 Rev. V
6-4 Rapidlab 1200 Operator’s Guide: Troubleshooting

Troubleshooting Failed Calibrations


Use this section to help determine causes and corrective actions for failed calibrations.
Probable
Error Cause Corrective Action
The parameter The parameter For recommendations to resolve failed calibrations,
has a single failed refer to Troubleshooting Checklist for Failed
line through it. calibration. Calibration‚ page 6-4.
View the events log to determine the event causing
the parameter to fail and follow the appropriate
corrective action for that event.
The parameter Perform a 2-point calibration to make the
was turned off parameter available again.
in Setup and
then turned on
again
The parameter The parameter View the events log to determine the event causing
has 2 crossed failed the parameter to fail and follow the appropriate
lines through calibration and corrective action for that event.
it. is unlikely to
become
available with
further
calibrations.

Troubleshooting Checklist for Failed Calibration


Perform the solutions in this checklist to help clear problems with failed calibrations:
• If D codes also exist for reagent problems such as D23, correct these problems first.
• Deproteinize the sample path if not done within the last week.
• If the sensor was newly installed or if maintenance was recently performed, allow
sufficient time for the sensor to equilibrate.
Perform additional calibrations.
• For pH, Na+, K+, Ca++, and Cl¯ sensors, if more than 2 sensors have excessive drift,
check the solution level in the reference sensor and look for salt in the vent hole,
bubbles in the sensor, or leaks.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-5

• Check the solution level in the affected sensor and remove bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The pH and Na+ sensors
should be completely full without any bubbles.
• Check the sensor contacts and measurement block for salt buildup.
• Check behind the sensors for fluid leaks that can come from the reference
sensor.
• Check that the sensors are installed in the correct order and are aligned, the
O-rings are in place, and the spring-loaded latch is closed.
• If the pH or Na+ sensor have a D2 or D3, condition the sensors.
• Check for cracks or leaks in the sample tubing, and replace the tubing if
necessary.
• Replace the affected sensor, if necessary.

Using the Calibration Report to Identify Problems


The full calibration report shows the measurement and drift values. Rapidlab 1200
systems use a 2-point calibration curve. The two points on the curve are the Cal
Point and Slope Point.
• The values in the Meas column represent the actual measured value of the
current calibration.
• The values in the Drift column represent the difference between the measured
value from the current calibration and the value assigned to the analyte during
the manufacture of the cartridge.
• If the system cannot report a value during a calibration, the result is blank on
the report and the D code and explanation prints at the bottom of the report
The following symbols can display with the results on the printed report.

Table 6-1 Symbols ↑ or ↓


This symbol... Indicates that...
↑ or ↓ the result is above or below the drift limit.

02087462 Rev. V
6-6 Rapidlab 1200 Operator’s Guide: Troubleshooting

Troubleshooting Patient Results


Use this section to identify the symbols that are displayed with results or instead of results
for a parameter.

Table 6-2 Symbols -----↑ or -----↓


Probable Cause Corrective Action
The result for the parameter is 1. Analyze the sample again, ensuring that the
above (-----↑) or below (-----↓) sample has no bubbles.
the reporting range for the Checking for bubbles is especially important
parameter. for samples introduced from capillary tubes.
NOTE: The system displays 2. Analyze QC samples and verify that the QC
these symbols in place of a result. results are within the target ranges.

Table 6-3 Symbol -----?


Probable Cause Corrective Action
The system detected an atypical Analyze the sample again to verify the result.
response when measuring the
parameter.
The sensor does not reach a For information about D5 No Endpoint, refer to D
stable reading within the Codes‚ page 6-47.
predefined time limit.
The sensor signal has excess For information about D6 Excessive Noise, refer to
noise. D Codes‚ page 6-47.

This symbol is displayed next to results on the screen and printed reports, and the system
displays the Interfering Substance message in the event log and on printed reports.

Table 6-4 Symbol #


Probable Cause Corrective Action
The sample contains substances Check the sample source and result, and ascertain
that may interfere with glucose or whether the presence of an interfering substance is
lactate measurement. likely.
For more information about interfering substances,
refer to Interference Testing‚ page E-6.
Repeated, unexpected occurrences of this message
may indicate sensor failure. Replace the sensor.

Table 6-5 Missing Results


Probable Cause Corrective Action
The parameter was turned off at Analyze the sample again, ensuring that the
the Analysis screen. parameter is turned on at the Analysis screen.
The parameter was turned off in Ensure that the parameter is turned on in System
Setup. Setup. Refer to Editing Demographics‚ page 2-25.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-7

Table 6-5 Missing Results


Probable Cause Corrective Action
The Rapidlink or Rapidcomm Contact your system supervisor for assistance if
data management system or the you need to analyze samples and obtain results for
LIS connected to the this parameter.
Rapidlab 1200 system turned the
parameter off.
The system could not report a Verify that the system reported valid results for all
result because a parameter used necessary parameters.
to determine the result was not To identify parameters that depend on other
reported, not available, or sample parameters for results, refer to Required
demographics were not entered. Parameters and Sample Demographics‚ page 8-17.
If demographics editing is turned on in Setup, recall
the sample results and enter the values for the
sample demographics. Refer to Editing
Demographics‚ page 2-25.
Ensure that the parameters and sample
demographics are turned on in Setup. Refer to
Setting up Parameters‚ page 8-13.

Troubleshooting Unavailable Buttons


Use this section when buttons at the Analysis screen are not available.
Problem Probable Cause Corrective Action
The QC! The lot is expired for the If the lot is expired, define a new lot of
button on the control that is currently control.
Analysis scheduled, or no lot is If no lot is defined for the current control,
screen is not entered for the control. enter the lot.
available.
All parameters are out Perform a 2-point calibration to make the
of calibration because parameter available again.
they were turned off in
Setup and then turned
on again.
The Analyze If all parameters are Contact your system supervisor for
button has a available, the Rapidlink assistance if you need to analyze samples.
line through it. or Rapidcomm data
management system or
the LIS connected to the
Rapidlab 1200 system
has turned analysis
functions off for the
Rapidlab 1200 system.

02087462 Rev. V
6-8 Rapidlab 1200 Operator’s Guide: Troubleshooting

Problem Probable Cause Corrective Action


All parameters are not View the events log to determine the event
available because they causing the parameter to fail, and follow
have failed scheduled the appropriate solutions for that event.
QC analysis or Analyze all the currently scheduled
scheduled QC analysis controls for required QC.
was not performed. Analyze QC for the failed level. Refer to
Performing Unscheduled QC Sample
Analysis‚ page 4-4. If the results are
within range, turn the parameter on. Refer
to Restoring Parameters‚ page 4-12.
All parameters are out Perform a 2-point calibration to make the
of calibration because parameter available again.
they were turned off in
Setup and then turned
on again.

Troubleshooting Measurement Module Lights


Problem Probable Cause Corrective Action
The lights in The ambient operating temperature is at No operator action is
the the upper end of the acceptable range. required. You can
measurement The measurement module lights are analyze samples and
module are turned off to help the system gain thermal report results.
turned off. control. However, to aid visibility of the When the ambient
sample path in the measurement module temperature cools and
during critical operations, the lights are the system gains
briefly turned on. For example, the lights thermal control, the
are turned on during sample and QC lights turn on and
analysis. remain on at all times.

Troubleshooting Barcode Problems


Barcode Quality
Ensure that the quality of the barcode label is acceptable. The ideal barcode label has
clean, clear, straight, fine lines with high contrast between light and dark areas. A white
background with black print provides the highest contrast.
Label quality can interfere with correct scanning. Avoid using labels with a highly
laminated surface or with poorly printed barcodes, such as those with broken areas,
smudges, or other irregularities. Environmental factors, such as exposure to dampness and
ultraviolet light, can also damage the barcodes during storage or use.
Ensure you are using an appropriate scanning technique. Refer to Scanning Technique‚
page 2-22.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-9

Resetting the Barcode Scanner


Reset the barcode scanner if the scanner no longer scans barcodes.
1. Scan the barcode shown below.

2. Shut the system down and then restart it.


Refer to Shutting Down the System‚ page 2-6.
Use the following table to identify the cause of problems with barcodes or the
barcode scanner.
Problem Probable Cause Corrective Action
Nothing is The system does Refer to Setting up Barcode Options‚
displayed when not recognize the page 8-23.
scanning the barcode, the The barcode scanner was not connected to
barcodes. barcode is turned the system correctly. For information
off in Setup, the about connecting the barcode scanner,
wrong symbology refer to Connecting the Barcode Scanner‚
was selected, or the page 8-26.
format was not
specified.
Scanning the The wrong field Select the button for the appropriate field
patient ID or the was selected when or select the field, and then scan the
accession number, you scanned the corresponding barcode. For example,
the barcode is barcode. select Patient ID and then scan the patient
displayed in the ID barcode.
wrong field on the
screen.
Scanning the The patient ID was 1. Ensure that the field is empty before
patient ID or the entered or scanned scanning the barcode.
accession number, incorrectly. 2. If the field is not empty, select the
the data entered on field and then select Clear to delete
the screen does not the data in the field.
match the barcode. If the problem persists, ensure that the
barcode format is correctly defined for
patient and accession number barcodes.
Refer to Setting up Barcode Options‚
page 8-23.

02087462 Rev. V
6-10 Rapidlab 1200 Operator’s Guide: Troubleshooting

Problem Probable Cause Corrective Action


The barcode Faulty scanning • Use the correct scanning technique.
scanner works technique, poor Refer to Scanning Technique‚
intermittently, or quality of the page 2-22.
data is not barcode print, or • Evaluate the print quality of the
displayed on the loose cable barcode and barcode label.
screen when you connection to the Refer to Barcode Quality‚ page 6-8.
scan. port on the • Ensure that the barcode scanner is
Rapidlab 1200 correctly connected to the
system can cause Rapidlab 1200 system.
poor scanner
• Ensure that the barcode scanner is
performance.
turned on and that the correct
symbology and format for patient
barcodes are selected.
Refer to Setting up Barcode Options‚
page 8-23.
• If you use Interleaved 2 of 5
barcodes, ensure that you entered the
correct barcode lengths for the
barcodes that you use.
• Ensure that you are scanning the
correct barcode for the sample or the
control.
The barcode Faulty scanning • Use the correct scanning technique.
scanner no longer technique, poor Refer to Scanning Technique‚
scans barcodes that quality of the page 2-22.
it scanned before. barcode print, or • Evaluate the print quality of the
loose cable barcode and barcode label.
connection to the Refer to Barcode Quality‚ page 6-8.
port on the • Ensure that the barcode scanner is
Rapidlab 1200 correctly connected to the
system can cause Rapidlab 1200 system.
poor scanner
• Ensure that the barcode scanner is
performance. The
turned on and that the correct
scanner may also
symbology and format for patient
need to be reset.
barcodes are selected.
Refer to Setting up Barcode Options‚
page 8-23.
• If you use Interleaved 2 of 5
barcodes, ensure that you entered the
correct barcode lengths for the
barcodes that you use.
• Ensure that you are scanning the
correct barcode for the sample or the
control.
• Reset the barcode scanner.
Refer to Resetting the Barcode
Scanner‚ page 6-9.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-11

Troubleshooting Internal Printer Problems


Problem Probable Cause Corrective Action
The internal printer The internal printer • If the printer is out of paper, install a
does not print at all. is out of paper, the new roll of paper.
paper is reversed or Refer to Replacing the Printer Paper‚
jammed in the page 5-42.
printer, or the • Ensure that the thermal paper is not
printer is not turned reversed and that it is feeding
on. correctly.
• Refer to Replacing the Printer Paper‚
page 5-42.
• Check to see of the paper is jammed
and clear the jam if necessary.
If you are unable to clear the paper
jam, call for technical assistance.
• Ensure that the printer is turned on.
The internal printer Replace the printer paper. Refer to
is not printing Replacing the Printer Paper‚ page 5-42.
correctly.

Troubleshooting Touchscreen Problems


Problem Corrective Action
The screen is blank. • Ensure that the screen is adjusted to the correct
viewing angle.
Grasp and squeeze the latch on top of the
screen and tilt the screen to the correct viewing
angle.
• Ensure that the power is on.
• Ensure that the power cord is connected to the
system and to the electrical outlet.
• Ensure that the fuses are not blown.
Refer to Replacing the System Fuses‚
page 5-47.
The touchscreen responds The touchscreen requires calibration. Refer to
inconsistently. For example, you Calibrating the Touchscreen‚ page 6-35.
must touch to the right or the left
of an item to select it.
The touchscreen does not The touchscreen was incorrectly calibrated. Call for
respond or it responds erratically technical assistance.
after calibrating the screen.

02087462 Rev. V
6-12 Rapidlab 1200 Operator’s Guide: Troubleshooting

Solving Communication Problems


The communications error symbol is displayed on the Analysis and the Results screen.
Probable Cause Corrective Action
An interfaced Rapidlink or • Ensure that the cable connecting the systems is
Rapidcomm system or tightly connected to each system.
laboratory information • Ensure that the cable is not damaged and that it is
system (LIS) does not the correct cable for connecting the systems.
communicate with the • Ensure that the Rapidlink or Rapidcomm data
Rapidlab 1200 system. management system or the LIS is correctly
configured to communicate with the
Rapidlab 1200 system.
• Ensure that the Rapidlab 1200 system is correctly
configured to communicate with the Rapidlink or
Rapidcomm system or the LIS and that the
connection is turned on.
Refer to Setting up Communications‚ page 8-26.
• Send the sample results or calibration data again
from the Rapidlab 1200 system by recalling the
results and selecting Send.
• If communication is not successful, record the
system message from the events log and call for
technical assistance.

Removing Obstructions from the Sample Path


The clot clearing procedure checks the components in the fluid path in the sequence in
which a clot or other obstruction is most likely to occur, first attempting to clear the
reagent manifold, then the preheater and reagent cartridge. If these attempts to clear the
obstruction fail, a procedure to clear the fluid path using a clot-removal line is provided.
Use the clot clearing procedure if an event code, such as D-39, directs you to ensure there
are no obstructions in the sample path by performing a clot clearing procedure. You should
also perform this procedure if you observe an obstruction in the sample path. To check if
the problem that prompted the event code is resolved, check the events log.
Required parts and supplies are shown in the 2 tables below.
Kit Part Number Description
Clot Clearing Kit 10378229 Includes clot clearing tool and clot-removal line.

Supplies Description
Plastic syringe Use to clear clots from the reagent manifold.
5cc Luer Lock syringe Use to clear clots from the preheater and reagent cartridge.
Gauze Use to catch excess liquid after insertion of water.
Water Use to fill syringe.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-13

The parts listed in the table below are optional, as explained in the Clearing the
Clot from the Reagent Manifold procedure below.
Optional Parts
Reagent Manifold Description
06646415 For Rapidlab 1240 and 1260 systems, if needed.
06643971 For Rapidlab 1245 and 1265 systems, if needed.

Clearing the Clot from the Reagent Manifold

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: A security access of level 1 or 2 is required to access Diagnostics features.


1. Pull out and lift the front cover of the system.
Enter your password, if necessary.
2. Select Status > Diagnostics.
Enter your password, if necessary.
3. At the Diagnostics screen, select Cartridges > Eject Both Cartridges.
Remove the reagent and wash cartridges.
4. Detach the reagent manifold.
a. Disconnect the waste tubing from the port on the top, right-side of the
reagent manifold (item 4, Figure 6-1).
b. Disconnect the reagent manifold tubing from the fitting that connects the
reagent manifold tubing to the CO-ox pump tubing (item 1, Figure 6-1).
This step only applies to Rapidlab 1245 and 1265 systems.

CAUTION: Do not disconnect the reagent manifold tubing from the port on the
top, left-side of the reagent manifold.

c. Push down the two latches that secure the reagent manifold to the system
(item 5, Figure 6-1).

02087462 Rev. V
6-14 Rapidlab 1200 Operator’s Guide: Troubleshooting

d. Carefully pull the reagent manifold out slightly, then straight down, to avoid the
sample connector (item 3, Figure 6-1).

1 Fitting to which the reagent manifold tubing and CO-ox pump tubing are connected
(Rapidlab 1245 and 1265 systems)
2 Reagent manifold tubing that connects the fitting to the port on the top, left-side of the
reagent manifold (Rapidlab 1245 and 1265 systems)
3 Sample connector
4 Waste tubing connected to port on top, right-side of the reagent manifold
5 Two latches that secure the reagent manifold to the system

Figure 6-1 Reagent Manifold and Tubing Connections

5. Place the reagent manifold on a stable, flat surface.


6. Fill the plastic syringe with water and place it against the sensor waste port (item 4,
Figure 6-2).
7. Press the syringe plunger gently to insert water into the CO-ox waste port, while
holding gauze against the end of the tubing that is connected to the
CO-ox waste exit port (item 2, Figure 6-2), to catch the obstruction and any excess
liquid.

BIOHAZARD: Discard the gauze according to the established biohazard disposal


practices of your workplace.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-15

8. Discard the gauze.

1 CO-ox waste exit port (this illustration shows ports only and does not show
the reagent manifold tubing that remains connected to this port when you
perform this procedure)
2 Sample exit port
3 Sensor waste exit port
4 Sensor waste port
5 Sample port
6 CO-ox waste port

Figure 6-2 Location of Reagent Manifold Ports and Exit Ports

9. Repeat the procedure on the sample port.


a. Fill the plastic syringe with water, and place it against the sample port
(item 5, Figure 6-2).
b. Press the syringe plunger gently to insert water into the CO-ox waste port,
while holding gauze against the end of the tubing that is connected
to the CO-ox waste exit port (item 2, Figure 6-2), to catch the obstruction
and any excess liquid.

CAUTION: Do not disconnect the reagent manifold tubing from the port on the
top, left-side of the reagent manifold.
c. Discard the gauze.

02087462 Rev. V
6-16 Rapidlab 1200 Operator’s Guide: Troubleshooting

10. Repeat the procedure on the CO-ox waste port (Rapidlab 1245 and 1265 systems).
a. Fill the plastic syringe with water and place it against the CO-ox waste port
(item 6, Figure 6-2).
b. Press the syringe plunger gently to insert water into the CO-ox waste port, while
holding gauze against the end of the tubing that is connected
to the CO-ox waste exit port (item 2, Figure 6-2), to catch the obstruction and any
excess liquid.
c. Discard the gauze.
11. If there is no obstruction in the reagent manifold, proceed to Clearing the Clot from
the Preheater on page 17.
There is no obstruction if water inserted into a port flushes cleanly through the
corresponding exit port.
If you cleared an obstruction from the reagent manifold, go to step 13 to reinstall the
reagent manifold.
12. If you detect an obstruction in the reagent manifold, but are unable to clear it, you
have 2 options, as described below.
• Perform a clot clearing procedure using a clot-removal line, as described in
Removing Clots Using the Clot-Removal Line‚ page 6-24. Then repeat this
procedure to ensure an obstruction has been removed. If this does not work, go to
step 13 to replace the reagent manifold with a new reagent manifold. See page
page 13 for reagent manifold part numbers.
• Replace the reagent manifold with a new reagent manifold, by following the
procedure in step 13 (for reagent manifold part numbers, see page 13).
There is an obstruction that has not been cleared in the reagent manifold if you insert
water into a port and the water does not flush cleanly through the corresponding exit
port.
13. Reinstall or replace the reagent manifold.
a. Insert the reagent manifold until it latches into place, using the 2 latches
(item 5, Figure 6-1) that secure the manifold to the system.
b. Reinsert the reagent manifold tubing (item 2, Figure 1) into the fitting
(item 1, Figure 6-1) that connects to the CO-ox pump tubing
(Rapidlab 1245 and 1265 systems).
c. Reinsert the waste tubing into the port on the top, right-side of the reagent
manifold (item 4, Figure 6-1).
14. Close the system.
a. Reinstall the reagent and wash cartridges.
b. Close the reagent and wash module doors.
c. Close the front cover of the system.
15. Select the Return button twice to exit Diagnostics mode.
You are prompted to calibrate the system.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-17

16. Select Yes to calibrate the system.


The clot clearing procedure is complete.

Clearing the Clot from the Preheater

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

Use this procedure only if the Clearing the Clot from the Reagent Manifold
procedure fails to clear the clot. The Clearing the Clot from the Preheater
procedure continues from step 11 on page 16.
1. Open the measurement module cover, by lifting the 2 latch buttons located at
the bottom left and right of the module. See Figure 6-3.

1 Measurement module latch buttons

Figure 6-3 Measurement Module Compartment Cover

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the module
frame to discharge static buildup.

02087462 Rev. V
6-18 Rapidlab 1200 Operator’s Guide: Troubleshooting

2. Replace the pO2 sensor with the clot clearing tool.


a. Push the black spring-loaded latch assembly (item 1, Figure 6-4), located at the
right of the 1200 Reference sensor, to the right, until the mechanism clicks in
place.

1 spring-loaded latch assembly


2 top of the pO2 sensor
3 lip of pO2 sensor

Figure 6-4 Measurement Module Compartment

b. Remove the pO2 sensor by lifting the sensor lip (item 2, Figure 6-4) up at the
bottom while pressing the top of the sensor (item 3, Figure 6-4) inward.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-19

c. Insert the clot clearing tool in the place of the pO2 sensor.

1 clot clearing tool


2 black lever

Figure 6-5 Clot Clearing Tool inserted in pO2 Sensor Slot

d. Press the black lever (item 2, Figure 6-5), located below the black
spring-loaded latch assembly, to reapply pressure to the sensor assembly.
3. Fill the syringe with water.
4. Insert the syringe in clot clearing tool (item 1, Figure 6-6).

1 Clot clearing tool


2 Syringe

Figure 6-6 Syringe inserted in Clot Clearing Tool

a. If using a Luer Lock syringe, thread the syringe into the clot clearing tool
to ensure the syringe is secured firmly to the clot clearing tool.

02087462 Rev. V
6-20 Rapidlab 1200 Operator’s Guide: Troubleshooting

b. If using a standard syringe, hold the syringe firmly.

CAUTION: If the path is totally obstructed, liquid may be expelled suddenly and
with great force through the port at the back of the sample connector.

5. Press the syringe plunger gently while holding gauze against the port at the back of the
sample connector (item 1, Figure 6-7), to catch the obstruction and any excess liquid.
6. Remove the syringe.

BIOHAZARD: Discard the gauze according to the established biohazard disposal


practices of your workplace.

7. Discard the gauze.

1 Fitting to which the reagent manifold tubing and CO-ox pump tubing are connected
(Rapidlab 1245 and 1265 systems)
2 Reagent manifold tubing that connects the fitting to the port on the top, left-side of the
reagent manifold (Rapidlab 1245 and 1265 systems)
3 Sample connector
4 Waste tubing connected to port on top, right-side of the reagent manifold
5 Two latches that secure the reagent manifold to the system

Figure 6-7 Reagent Manifold and Tubing Connections

8. Reinstall the reagent manifold.


a. Insert the reagent manifold until it latches into place, using the 2 latches (item 5,
Figure 6-7) that secure the manifold to the system.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-21

b. Reinsert the reagent manifold tubing (item 2, Figure 6-7) into the fitting
(item 1, Figure 6-7) that connects to the CO-ox pump tubing
(Rapidlab 1245 and 1265 systems).
c. Reinsert the waste tubing into the port on the top, right-side of the reagent
manifold (item 4, Figure 6-7).
If an obstruction has been cleared, go to step 9.
If an obstruction has not been cleared, go to Clearing the Clot from
the Reagent Cartridge‚ page 6-22.
9. Reinstall the pO2 sensor.
a. Push the black spring enclosure assembly to the right, until the
mechanism clicks in place.
b. Remove the syringe.
c. Remove the clot clearing tool, by lifting the clot clearing tool lip up at the
bottom while pressing the top of the tool inward.
d. Reinstall the pO2 sensor.
e. Press the black spring enclosure assembly lever to reapply pressure to the
sensor assembly.
10. Close the system.
a. Reinstall the reagent and wash cartridges.
b. Close the reagent and wash module doors.
c. Close the front cover of the system.
11. Select the Return button twice to exit Diagnostics mode.
You are prompted to calibrate the system.
12. Select Yes to calibrate the system.
The clot clearing procedure is complete.

02087462 Rev. V
6-22 Rapidlab 1200 Operator’s Guide: Troubleshooting

Clearing the Clot from the Reagent Cartridge

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

Use this procedure only if the Clearing the Clot from the Preheater procedure fails to clear
the obstruction. The Clearing the Clot from the Reagent Cartridge procedure continues
from step 8 of the Clearing the Clot from the Preheater procedure, that begins on page 20.
1. Reinstall the reagent and wash cartridges.
2. Close the reagent and wash module doors.
3. Select the Return button.
4. Ensure the Reagent sample port is in position 2 by following these steps:
a. Select Pumps and Valves.
b. Select R Valve > Start > Change.
The character 2 displays on the screen.
5. Fill the syringe with water.
6. Insert the syringe into the clot clearing tool.
a. If using a Luer Lock syringe, thread the syringe into the clot clearing tool to
ensure the syringe is secured firmly to the clot clearing tool.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-23

b. If using a standard syringe, hold the syringe firmly.


7. Press the syringe plunger gently into the clot clearing tool, while holding
gauze against the sample port of the reagent cartridge, to catch the obstruction
and any excess liquid. The sample port location is shown in Figure 6-8.

1 Sample port of reagent cartridge in position 2

Figure 6-8 Sample Port of Reagent Cartridge

BIOHAZARD: Discard the gauze according to the established biohazard disposal


practices of your workplace.

8. Remove the syringe, and discard the gauze.


If an obstruction is cleared, it is expelled, along with any excess liquid,
through the sample port on the reagent cartridge.
9. Reinstall the pO2 sensor.
a. Push the black spring enclosure assembly to the right, until the
mechanism clicks in place.
b. Remove the syringe.
c. Remove the clot clearing tool, by lifting the clot clearing tool lip up at the
bottom while pressing the top of the tool inward.
d. Reinstall the pO2 sensor.

02087462 Rev. V
6-24 Rapidlab 1200 Operator’s Guide: Troubleshooting

e. Press the black spring enclosure assembly lever to reapply pressure to the sensor
assembly.
10. Close the measurement module cover.
11. Close the front cover of the system.
12. Select Stop.
13. Select the Return button twice to exit Diagnostics mode.
You are prompted to calibrate the system.
14. Select Yes to calibrate the system.
15. Replace the reagent sample port by following this procedure:
a. Select Status > Maintenance > Replace Sample Port.
b. Select the Continue.
Follow the instructions in the video to replace the sample port.
16. If the reagent manifold, preheater, and reagent cartridge clot clearing procedures fail
to locate the obstruction, see Removing Clots Using the Clot-Removal Line‚
page 6-24.

Removing Clots Using the Clot-Removal Line


Use the following procedure if the clot clearing procedures in the preceding section fail to
remove the obstruction.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.

Inspecting the Sample Path


1. Remove the reagent cartridge and the wash cartridge:
a. Select Status > Diagnostics > Cartridges > Eject Both Cartridges.
b. Remove both the cartridges.
c. Leave the doors open.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-25

NOTE: Use gauze to catch waste material cleared by the clot-removal


line.
2. To remove obstructions from the sample tubing in the reagent manifold, push
the clot-removal line through the fluid connector on the reagent manifold.

1 Sample connector
2 Fluid connector

Figure 6-9 Sample Tubing in the Reagent Manifold

3. Remove obstructions from the preheater:


a. Remove the pO2 and pCO2 (gas) sensors.

02087462 Rev. V
6-26 Rapidlab 1200 Operator’s Guide: Troubleshooting

b. Push a clot-removal line through the preheater from right to left, opposite to the
direction of sample flow, until you see the clot-removal line at the sample
connector.

1 Preheater
2 Sample connector

Figure 6-10 Rapidlab 1200 Systems Sample Path

CAUTION: Do not push the clot-removal line through the gas sensors. To avoid
damaging the gas sensors, do not exert excessive pressure to the gas sensor
membranes.
4. Inspect the pO2 and pCO2 (gas), sample ground/temperature, pH, and the reference
sensors for obstructions:
a. Remove the gas sensors one at a time and inspect each one for obstructions.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-27

b. If you detect an obstruction, fill a syringe with water, place the syringe
against the sample path and inject water through the sample path.

1 Sensor
2 Syringe

Figure 6-11 Injecting Water into the Gas Sensor Sample Path

CAUTION: Use the clot-removal line carefully to avoid damage to the sample
ground/temperature, pH, and reference sensors.

c. For the sample ground/temperature sensor, pH sensor, and reference


sensor, push the clot-removal line through the sample path to remove
obstructions.

1 Sensor cartridge
2 Clot-removal line

Figure 6-12 Clot-Removal Line in Sensor Sample Path

02087462 Rev. V
6-28 Rapidlab 1200 Operator’s Guide: Troubleshooting

d. If the obstruction is not removed, use a syringe filled with water and inject the
water through the sample path.
5. For Rapidlab 1260 and 1265 systems, inspect the Na+, Ca++, Cl¯, K+, Glu, and Lac
sensors for obstructions:
a. Remove the sensors one at a time and inspect each one for obstructions.

CAUTION: Do not push the clot-removal line through the Ca++, Cl¯, K+, Glu, and
Lac sensors. Pushing the clot-removal line through these sensors could cause
damage to the sensors.

CAUTION: Do not exert excessive pressure on the glucose or lactate sensor


membrane.

b. Fill a syringe with water, place the syringe against the sample path, and inject
water through the sample path.
c. If the obstruction is not removed from the Na+ sensor, push the clot-removal line
through the sample path to remove obstructions.
6. Remove obstructions from the path through the latch:
a. Grasp the tab on the reference sensor and pull it up and out of the measurement
module.
b. Disconnect the pinch valve tubing from the spring-loaded latch.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-29

c. Push a clot-removal line through the latch.

1 Pinch valve tubing


2 Spring-loaded latch

Figure 6-13 Rapidlab 1200 Systems Sample Path

7. Remove obstructions from the sample waste path in the reagent manifold:
a. Disconnect the tubing from the reagent manifold.

02087462 Rev. V
6-30 Rapidlab 1200 Operator’s Guide: Troubleshooting

b. Push the clot-removal line through the fluid connector on the reagent manifold
until the clot-removal line appears again.

1 Fluid connector

Figure 6-14 Rapidlab 1200 Systems Sample Path

Reinstalling the Sensors


1. Dry each sensor, ensure that the O-rings are in place, and then reinstall each sensor.
2. Connect the pinch valve tubing to the latch and the reagent manifold.
3. Press the tab on the spring-loaded latch to release the latch.
4. Close the measurement module door.

Completing the Inspection Procedure


1. Reinstall the cartridges and close the reagent and wash doors.
2. Perform the RCx reagent flow test:
a. Select Return.
b. Select Fluidic Functions > RCx.
c. Look at the sample path for obstructions and flow problems.
3. Select Wash Cycle.
4. Select Return.
5. Select Analyze > Yes.
6. Verify sensor performance by analyzing a minimum of 2 levels of quality control
material.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-31

Removing Obstructions from the CO-ox Sample Path


Use the following procedure to remove obstructions from the CO-ox sample path
where you see fluid restrictions and obstructions, or suspect problems based on
D code messages.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

CAUTION: Do not remove or return the sensors to the measurement module


without first discharging static buildup. Touch the inner surface of the
measurement module frame to discharge static buildup.
1. Remove the reagent cartridge and the wash cartridge:
a. Select Status > Diagnostics > Cartridges > Eject Both Cartridges.
b. Remove both the cartridges.
c. Leave the doors open.
2. If the obstruction is between the sample chamber and the measurement
module connector, replace the CO-ox sample tubing:
a. Disconnect the sample tubing from the connector on top of the sample
chamber.

1 Sample chamber connector


2 Fluid detector
3 Measurement module connector

Figure 6-15 CO-ox Sample Path

02087462 Rev. V
6-32 Rapidlab 1200 Operator’s Guide: Troubleshooting

b. Rotate the gray wheel towards you, pull the tubing through the fluid detector, and
remove the tubing from the steel measurement module connector.
c. Push the new tubing through the fluid detector.
d. Connect the tubing to the steel measurement module connector and to the sample
chamber connector.
Use a clamp or tweezers to help you attach the tubing.
3. Remove obstructions from the CO-ox waste tubing:
a. Disconnect the tubing from the steel fluid connector and the connector in the
pump tubing.

1 Steel fluid connector

Figure 6-16 CO-ox Sample Path

b. Push a clot-removal line through the tubing, opposite the direction of sample flow.
c. Reconnect the CO-ox waste tubing.
4. Remove obstructions from the waste path in the reagent manifold:
a. Disconnect the CO-ox pump tubing from the reagent manifold tubing at the
fitting.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-33

b. Push the clot-removal line through the fluid connector on the reagent
manifold.

1 Pump tubing at the fitting.


2 Fluid connector.

Figure 6-17 CO-ox Sample Path to Waste

c. Re-connect the CO-ox pump tubing.


5. Reinstall the cartridges and close both the reagent and wash doors.
6. Perform the RCx reagent flow test:
a. Select Back > Fluidic Functions > RCx.
b. Look at the sample path for obstructions and flow problems.
7. Return to the Status screen to view the events log.
8. Verify sensor performance:
a. Perform a 2-point calibration.
b. Analyze a minimum of 2 levels of quality control material.

Using Diagnostics
NOTE: Operators with level 1 or level 2 security access can access the diagnostic
tests.
NOTE: The system cannot perform routine fluidic activities while the Diagnostics
screen or subscreens are displayed. When you exit from the Diagnostics screen,
the system may perform an extended calibration before you can use the system.

02087462 Rev. V
6-34 Rapidlab 1200 Operator’s Guide: Troubleshooting

Copying Diagnostic Data


Refer to Copying Diagnostic Data‚ page 7-3.

Using the Diagnostics Screen


The Diagnostic screen has options to perform the following functions:
• print diagnostic reports
• perform the Waste Detector Calibration
• perform the Screen Calibration
• access other diagnostic screens

Performing Tests and Printing Diagnostic Reports


Use this procedure to print diagnostic reports:
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Print the appropriate report:
To print the... Select...
Temperature report, Temperature.
Prints the temperature for various system components and
the current pAtm providing the system ID, the date and time
of the report, and temperature information.
Last Cal report, Sensors > Last Cal.
Prints data for each sensor from the last 2-point or full
calibration. Refer to Using the Sensors Screen‚ page 6-44.
Measurement report, Sensors > Measurement.
Prints an index and one snapshot of measurement readings
for all sensors.
Voltage and Voltage and Temperatures.
Temperatures report, Prints the voltage and temperatures.
Printer report, Printer.
Prints all printable characters providing the system ID, the
date and time of the report, and the printer data.
Wavelength Cal report CO-ox > Wavelength Cal.
(Rapidlab 1245 and
1265 systems),

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-35

Performing the Waste Detector Calibration


Use this procedure to calibrate the waste detector for the waste bottle.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Waste Detector.
4. Remove the waste bottle, empty it, and set it aside.
5. Select Continue and wait while the system calibrates without the bottle.
6. Fill the waste bottle with tap water to the Max line.
7. Reinstall the bottle, and wait while the system calibrates with the full bottle.
8. Remove the waste bottle, empty it, and reinstall the empty bottle.
The system returns to the Diagnostics screen when finished.
9. To return to the Status screen, select Return.
The systems perform a wash.

Calibrating the Touchscreen


Use this procedure to calibrate the touchscreen when the screen responds
inconsistently to selects. For example, if you must select to the left or the right
of an item to select it, the touchscreen needs calibration.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Screen Calibration.
The screen displays a button.
NOTE: If you do not want to calibrate the touchscreen, do not touch the
screen. The system automatically returns to the Diagnostics menu after 30
seconds.

CAUTION: Do not select any other part of the screen and do not select the button
more than once each time it appears. Touching any other part of the screen or
touching the button more than once causes the screen to become inoperable. If this
occurs, call for technical assistance.
4. Select the button.
The button changes position on the screen.
5. Continue selecting the button again until the system returns to the Diagnostics
screen.
6. To return to the Status screen, select Return.

02087462 Rev. V
6-36 Rapidlab 1200 Operator’s Guide: Troubleshooting

Using the Fluidic Functions Screen


The Diagnostics > Fluidic Functions screen displays buttons for performing the following
actions:
• perform Reagent Flow test for Wash, 200 Cal, Slope Cal, RCx, or Wash Cycle
• prime the AQC Cartridge
• perform the Leak Test
The Fluidic Function screen also displays a graphic of the Rapidlab system fluidics to
enable you to localize the site of any leak. The graphic is only displayed when the system
detects a leak after you perform the leak test.

Performing the Reagent Flow Tests


The system highlights one or more of the Fluidic Function buttons to indicate that you
should perform that test to clear a current error. The system removes the highlighting
when you perform the test successfully.
Use this procedure to test the flow of reagents from the reagent and wash cartridges.
Test Description
Wash (wash cartridge) performs the wash section of a calibration
200 cal (reagent cartridge) performs the 200 cal section of a calibration
Slope cal (reagent cartridge) performs the Slope cal section of a calibration
RCx (wash cartridge) performs the RCx section of a calibration
Wash Cycle (wash cartridge) perform a wash sequence
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Fluidic Functions.
4. Select the test to perform.
The system moves the reagent through the sample path.
5. Look for obstructions or uneven flow that may indicate a problem.
6. To test another reagent, repeat this procedure from step 4.
7. Select Return.
8. To return to the Status screen, select Return.
The system performs a wash.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-37

Priming the AQC Cartridge


Use this procedure to test the flow of each level of QC material from the
AutomaticQC cartridge.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Fluidic Functions > Prime AQC Cartridge.
4. Wait while the system moves each level of QC material through the sample
path.
5. Select Return.
6. To return to the Status screen, select Return.
The system performs a wash.

Performing the Leak Test


This test evaluates the pressure in the sample path. Use this procedure to test if the
sample path has any leaks. If an illustration of the Rapidlab fluid paths displays on
the screen, a leak is present. The illustration highlights the probable area of the
leak. Pass status is indicated by a gray button and Fail status by a yellow button.
You can also print a leak test report. The printed leak test report contains
information identifying the area of the leak. The leak test localizes the leak to 1 of
3 areas and 2 levels of severity.
In some cases, a leak test may be unable to run because of causes related to but not
originating in the leak test, such as D73, D33, and D23:14 events. When this
occurs the printed leak test report displays a message that says Unable to run. If
this occurs, use the event log to identify and address the issues that cause the leak
test to cancel. This message does not display on the screen.
The printed report displays the information as Leak Test Passed or Stage xx
Failed. The xx could be 1a, 2a, 3a, 1b, 2b, 3b.
• The number indicates how much of the system was tested before the failure
was detected, as explained in the table below.
• The letter indicates the severity of the leak, as explained in the table below.
Area Completed
1 from the pump through the pressure sensor
2 all of area 1, the measurement module to the wash and CO-ox slide cell in the
closed position
3 all of area 2 but with the CO-ox slide cell in the open position

Severity of Leak
a indicates a failure to create any pressure, a big leak
b indicates a failure to maintain pressure, a small leak

02087462 Rev. V
6-38 Rapidlab 1200 Operator’s Guide: Troubleshooting

Use the following steps to perform the leak test.


1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Fluidic Functions > Leak Test.
4. Wait while the system performs the test.
a. When the screen displays a Rapidlab illustration, use it to determine the probable
area of the leak.
b. If the test fails, do the following:
• look for highlighted Fluidic Function buttons
These are tests you can perform to clear the leak.
• check the tubing for leaks
• ensure that you installed the tubing correctly in the pinch valve
• ensure that the O-rings are in place
• ensure that you closed the spring-loaded latch
• For Rapidlab 1245 and 1265 systems, verify that the CO-ox sample chamber
is installed correctly.
5. Select Return.
6. To return to the Status screen, select Return.
The system performs a wash.

Using the Pumps and Valves Screen


The Diagnostics > Pumps and Valves screen displays buttons for performing the following
actions:
• Perform the Sample Pump and Wash Pump Tests
• Perform the R Cartridge Valve Test
• Perform the AQC Valve Test
• Perform the Measurement Module Pinch Valve Test
• Perform the CO-ox Pump Test

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-39

Performing the Sample Pump and Wash Pump Tests


Use this procedure to test the sample pump or the wash pump located on the
system behind the reagent cartridge.
The pump test moves the pump at 4 speeds numbered 1 through 4. When you
select Change, the system displays the number of the current speed on the screen.
The test is complete when the system displays speed 4 on the screen.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.


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

1. Select Status > Diagnostics.


2. Enter your password, if necessary.

CAUTION: Do not remove the wash or reagent cartridges for longer than 6 hours.
If the wash or reagent cartridge is removed from the system for longer than 6
hours, the cartridges are no longer valid.
3. Remove the reagent cartridge:
a. Select Cartridges > Eject R Cartridge.
b. Remove the reagent cartridge from the system and close the door.
c. Select Return.
4. Select Pumps and Valves.
To test the... Select...
sample pump, which is located on the Sample Pump > Start.
right as you face the system, The pump rotates toward you at the first
speed.
wash pump, which is located on the left as Wash Pump > Start.
you face the system, The pump rotates away from you at the
first speed.

02087462 Rev. V
6-40 Rapidlab 1200 Operator’s Guide: Troubleshooting

5. Look for obstructions and listen for any unusual noises that may indicate a problem
with the pump.
a. Select Change to advance the pump to the next speed.
b. Continue selecting Change and listening and looking for problems until you have
tested all 4 speeds.
6. Select Stop.
7. If you want to test the other pump, repeat this procedure from step 4.
8. Select Return to return to the Diagnostics screen.
9. Reinstall the reagent cartridge:
a. Select Cartridges > Eject R Cartridge.
b. Install the reagent cartridge and close the door.
10. Select the Return.
11. To return to the Status screen, select Return.
The system performs a prime and a full calibration.

Performing the R Cartridge Valve Test


Use this procedure to test the components that operate the valve located inside the reagent
cartridge. The test moves the valve to 3 positions. When you select the Change button, the
system displays the number of the current position on the screen. The test is complete
when the system displays position 3 on the screen.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Pumps and Valves > R Valve > Start.
The reagent valve moves to the first position. If the valve is already in this position, no
movement occurs.
4. Listen for any unusual noises that may indicate a problem with the valve.
5. Select Change to move the valve to the next position.
If the valve cannot reach the position, the Change button is not available.
6. Continue selecting Change and listening for problems until you have tested all 3
positions.
7. Select Stop and wait while the system moves the valve.
8. Select Return.
9. To return to the Status screen, select Return.
The system performs a wash.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-41

Performing the AQC Valve Test


Use this procedure to test the components that operate the valve located inside the
AutomaticQC cartridge. The test moves the valve from the home position to each
fluid position. During the procedure, select Change to move the valve to the next
position. The system displays the number of the position on the screen.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Pumps and Valves > AQC Valve > Start.
The system moves the valve to the first position.
4. Listen for any unusual noises that may indicate a problem with the valve.
5. Select Change to move the valve to the next position and then listen for
problems.
If the valve cannot reach the position, the Change button is not available.
6. Continue selecting Change and listening for problems until you have tested
all 5 positions.
7. Select Stop and wait while the system moves the valve.
8. Select Return.
9. To return to the Status screen, select Return.
The system performs a wash.

Performing the Measurement Module Pinch Valve Test


Use this procedure to test the components that operate the valve located on the
waste side of the measurement module. The test opens and closes the pinch valve.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Pumps and Valves > Pinch Valve > Start.
4. Select Change to close the pinch valve.
Ensure that the pinch valve is closed.
5. Select Change to open the pinch valve.
Ensure that the pinch valve is open.
6. Select Stop > Return.
7. To return to the Status screen, select Return.
The system performs a wash.

02087462 Rev. V
6-42 Rapidlab 1200 Operator’s Guide: Troubleshooting

Performing the CO-ox Pump Test


NOTE: This test only applies to the Rapidlab 1245 and 1265 systems.

Use this procedure to test the CO-ox pump. The pump test moves the pump at 4 speeds
numbered 1 through 4. When you select the Change button, the system displays the
number of the current speed on the screen. The test is complete when speed 4 is displayed
on the screen.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select Pumps and Valves > CO-ox Pump > Start.
The CO-ox pump rotates at the first speed.
4. Look for obstructions and listen for any unusual noises that may indicate a problem
with the pump.
5. Select Change to advance the pump to the next speed.
6. Continue selecting Change and listening and looking for problems until you have
tested all 4 speeds.
7. Select Stop and wait while the system returns the pump to the correct position.
8. Select Return.
9. To return to the Status screen, select Return.
The system performs a wash.

Using the Cartridges Screen


The Diagnostics > Cartridges screen displays buttons for performing the following
actions:
• ejecting the wash cartridge
• ejecting the reagent cartridge
• ejecting both the wash and reagent cartridges
• ejecting the AQC Cartridge

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-43

Ejecting the Wash or Reagent Cartridge


Use the Eject Cartridges buttons to eject cartridges when you need to access
components behind the cartridges.
1. Select Status > Diagnostics.

CAUTION: Do not remove the wash or reagent cartridges for longer than 6 hours.
If the wash or reagent cartridge is removed from the system for longer than 6
hours, the cartridges are no longer valid.
2. Enter your password, if necessary.
3. Select Cartridges.
To eject the... Select...
wash cartridge, Eject W Cartridge.
reagent cartridge, Eject R Cartridge.
both cartridges, Eject Both Cartridges.

The eject mechanism moves to eject the specific cartridge or cartridges.


4. When you complete the necessary task, reinstall the cartridge and push the
door closed.
5. Select Return.
6. To return to the Status screen, select Return.
If you eject any combination of reagent and wash cartridge, the system performs a
prime. The system defers the prime until you leave the Diagnostics screen.

Ejecting the AutomaticQC Cartridge


Use this procedure to eject the AutomaticQC (AQC) cartridge.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Open the cartridge connector.
4. Select Cartridges > Eject AQC Cartridge.
5. Dispose of the cartridge.
During normal operation, the AutomaticQC cartridge does not come in
contact with biohazardous materials from the system. However, you should
dispose of the cartridge according to your institution’s protocol for
biohazardous materials.
6. Select Return.
7. To return to the Status screen, select Return.

02087462 Rev. V
6-44 Rapidlab 1200 Operator’s Guide: Troubleshooting

Using the Sensors Screen


The Sensors screen has two print buttons:
• Last Cal
• Measurement
The Last Cal report contains data for each sensor from the last 2-point or full calibration.
The report provides the system ID, the date and time of the report, and sensor data in the
order represented in Table 6-6.
The Measurement report contains a measurement of readings for all the sensors.
For information about printing the Last Cal or Measurement report, refer to Performing
Tests and Printing Diagnostic Reports‚ page 6-34.

Table 6-6 Last Cal Report Values


Row number Sensor
1 pH
2 pCO2
3 pO2
4 Na+
5 K+
6 Ca++
7 Cl¯
8 Glu
9 Lac

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-45

Using the CO-ox Screen


Only Rapidlab 1245 and 1265 systems use the functions on the CO-ox screen.
The Diagnostics–CO-ox screen displays buttons for performing the following
actions:
• testing the lamp calibration
• testing wavelength calibration
• testing the CO-ox Sample Chamber
• turns the CO-ox lamp off or on

Performing the Lamp Calibration Test


This test is only performed on Rapidlab 1245 and 1265 Systems.
Perform this test whenever you change the CO-ox lamp or whenever you remove
and reinstall the lamp. You can also use this test to perform a lamp calibration.
The system displays the pass or fail results on a printed report.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select CO-ox > Lamp Cal.
4. Wait while the system performs the test.
The system prints test results as Passed or Failed.
5. Select Return.
6. To return to the Status screen, select Return.
The system performs a full calibration.

02087462 Rev. V
6-46 Rapidlab 1200 Operator’s Guide: Troubleshooting

Performing the Wavelength Cal Test


The Wavelength Cal test verifies the proper operation of the CO-ox neon lamp and prints
the results providing the system ID, the date and time of the report, and as represented in
Table 6-7.
To perform the Wavelength Cal Report, select CO-ox > Wavelength Cal.

Table 6-7 Wavelength Cal Report


Row number Data
1 Mean
2 Standard deviation
3 Measured position
4 Baseline position
5 Shift
6 Integration time from last zero
7 Serial number

Performing the CO-ox Sample Chamber Test


This test is only performed on Rapidlab 1245 and 1265 Systems.
Use this procedure to test the ability of the CO-ox sample chamber to move to the open
and close positions. The systems displays the pass or fail results on a printed report.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select CO-ox > Start.
The sample chamber moves to the open position.
4. Select Change to move the sample chamber to the closed position.
5. Select Stop.
The system prints the test results Passed or Failed.
6. Wait while the system returns the sample chamber to the correct position.
7. Select Return.
8. To return to the Status screen, select Return.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-47

Performing the Lamp On/Off Test


Use this procedure for Rapidlab 1245 and 1265 systems to test the CO-ox lamp.
1. Select Status > Diagnostics.
2. Enter your password, if necessary.
3. Select CO-ox > Lamp On/Off.
The CO-ox lamp turns on.
4. Open the door at the back of the system and look to see if the lamp is turned
on.
5. Select Lamp On/Off a second time.
The CO-ox lamp turns off.
6. Close the door at the back of the system.
7. Select Return.
8. To return to the Status screen, select Return.
The system automatically turns the lamp off when you exit the Diagnostics
screen.

D Codes
The Rapidlab 1200 diagnostics system assists operators in identifying and
resolving hardware problems. This section describes the Rapidlab 1200 system
diagnostic codes (D codes) and messages, the conditions that cause them, and
possible solutions. D codes identify changes in the system operation that require
corrective action.
Some D codes contain a qualifier after the message. The qualifier indicates a
specific condition related to the D code. For example, D2 indicates excessive drift
for a sensor. D2 Excessive Drift pO2 indicates that the pO2 sensor has excessive
drift. A qualifier that is a number, such as the number 7 in D35 Electronics Error:
7, is important information for the Service Representative.
Work through the corrective actions step by step until the problem is resolved.
When performing recommended corrective actions, refer to procedures described
in this manual and follow the manufacturer’s recommendations. To determine if
your action cleared the D code, view the events log.
For quick access to D code information, select Help.

02087462 Rev. V
6-48 Rapidlab 1200 Operator’s Guide: Troubleshooting

D2 Codes
D2 Excessive Drift: pO2 pCO2
Problem Corrective Action
Sensor drift is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • If the sensor was newly installed or if maintenance was
calibration recently performed, allow sufficient time for the sensor to
operations. equilibrate.
• Perform additional calibrations.
• If a D2 for pCO2, with a drift greater than 4.0 mmHg,
occurs twice in a 4-hour period and no drift occurs for pO2,
perform QC analysis.
If the pCO2 result is out of range, replace the sensor.
• Deproteinize the sample path.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-49

D2 Excessive Drift: Na+ K+ Ca++ Cl¯


Problem Corrective Action
Sensor drift is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • If the sensor was newly installed or if maintenance was
calibration recently performed, allow sufficient time for the sensor to
operations. equilibrate.
• Perform additional calibrations.
• If more than one sensor has excessive drift, check the
reference sensor for KCl leaks.
• Deproteinize the sample path.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• If both the pH and Na+ sensors have drift, condition the
sensors.
Refer to Conditioning the Sensors‚ page 5-6.
• Check the solution level in the affected sensor and look for
bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The
pH and Na+ sensors should be full. If the solution level is
low, refill the sensor.
• If more than one sensor has drift, check the solution level in
the reference sensor and look for salt in the vent hole and
bubbles in the sensor.
• Clean and refill the reference sensor as needed, or replace
it.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• Check the sensor contacts and measurement block for salt
buildup.
Check behind the sensors for fluid leaks that can come from
the reference sensor. If salt or leaks are present, clean the
sensor with water, dry, reinstall and perform a 2-point
calibration. Refer to Performing Manual Calibrations‚
page 3-4.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

02087462 Rev. V
6-50 Rapidlab 1200 Operator’s Guide: Troubleshooting

D2 Excessive Drift: Glu Lac


Problem Corrective Action
Sensor drift is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • If the sensor was newly installed or if maintenance was
calibration recently performed, allow sufficient time for the sensor to
operations. equilibrate.
• Perform additional calibrations.
• If the glucose sensor is > 30 days old or the lactate sensor is
> 5 days old, replace the sensor.
• Check that the biosensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
• Check the biosensor contacts and measurement block for
salt buildup.
• Check behind the biosensor for fluid leaks that can come
from the reference sensor.
If salt or leaks are present, clean the sensors with water, dry,
reinstall, and perform a 2-point calibration. Refer to
Recalling Calibration Results‚ page 3-4.
• If the biosensor has been installed less than 1 day, perform
2-point calibrations as necessary.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

D2 Excessive Drift: tHb


Problem Solution
The tHb slope drift Correct any reagent problems such as D23 codes before you
is beyond attempt to correct this D code.
predefined limits • Perform a full calibration.
during the
Refer to Performing Manual Calibrations‚ page 3-4.
calibration.
• If the problem persists, replace the CO-ox sample chamber.
• If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-51

D3 Codes
D3 Slope Error: pO2 pCO2
Problem Solution
Sensor slope is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • Perform a 2-point calibration.
calibration Refer to Performing Manual Calibrations‚ page 3-4.
operations.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

D3 Slope Error: pH Na+ K+ Ca++ Cl¯ Ref


Problem Corrective Action
Sensor slope is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • Perform a 2-point calibration.
calibration
Refer to Performing Manual Calibrations‚ page 3-4.
operations.
• Deproteinize the sample path and condition the sensors.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• Check the solution level in the affected sensor and look for
bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The pH
and Na+ sensors should be full. If the solution level is low,
refill the sensor.
• If more than one sensor or the reference sensor has the slope
error, look for salt in the vent hole and bubbles in the sensor.
• Clean and remove bubbles from the reference sensor as
needed.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• Check the sensor contacts and measurement block for salt
buildup.
• Check behind the sensor for fluid leaks that can come from
the reference sensor.
If salt or leaks are present, clean the sensor with water, dry,
reinstall, and perform a 2-point calibration. Refer to
Performing Manual Calibrations‚ page 3-4.

02087462 Rev. V
6-52 Rapidlab 1200 Operator’s Guide: Troubleshooting

Problem Corrective Action


• If the problem persists, replace the sensor.
If the reference sensor has the slope error, the K+, Ca++, Cl¯,
pH, and Na+ sensors will also have slope errors.
Replace the reference sensor before replacing the other
sensors.
• If the problem persists, call for technical assistance.

D3 Slope Error: Glu Lac


Problem Corrective Action
Sensor slope is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during • Perform a 2-point calibration.
calibration
Refer to Performing Manual Calibrations‚ page 3-4.
operations.
• If the glucose sensor is > 30 days old or the lactate sensor is
> 5 days old, replace the sensor.
• Check that the biosensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• Check the biosensor contacts and measurement block for
salt buildup.
• Check behind the biosensor for fluid leaks that can come
from the reference sensor.
If salt or leaks are present, clean the sensors with water, dry,
reinstall, and perform a 2-point calibration. Refer to
Performing Manual Calibrations‚ page 3-4.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

D3 Slope Error: tHb


Problem Corrective Action
The tHb slope is • Perform a full calibration.
beyond predefined Refer to Performing Manual Calibrations‚ page 3-4.
limits during the • Push on the sample chamber to ensure that it is installed
calibration. correctly and is locked in place.
• If the problem persists, replace the CO-ox sample chamber.
• If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-53

D4 Codes
D4 Offset Error: pO2 pCO2
Problem Corrective Action
Sensor offset is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during a • Perform a 2-point calibration.
1-point or a 2-point Refer to Performing Manual Calibrations‚ page 3-4.
calibration.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

D4 Offset Error: pH Na+ K+ Ca++ Cl¯


Problem Corrective Action
Sensor offset is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during a • Perform a 2-point calibration.
1-point or a 2-point
Refer to Performing Manual Calibrations‚ page 3-4.
calibration.
• Check the solution level in the affected measurement sensor
and look for bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The pH
and Na+ sensors should be full. If the solution level is low,
refill the sensor.
• If K+ or Ca++ have an offset error, replace the fill solution
even if the fluid levels are sufficient.
• If more than one sensor has the offset error, check the
solution level in the reference sensor and look for salt in the
vent hole and bubbles in the sensor.
• Clean and refill the reference sensor as needed.
• Check that the sensors are installed in the correct location
and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

02087462 Rev. V
6-54 Rapidlab 1200 Operator’s Guide: Troubleshooting

D4 Offset Error: Glu Lac


Problem Corrective Action
Sensor offset is Correct any reagent problems such as D23 codes before you
beyond predefined attempt to correct this D code.
limits during a • Check that the biosensors are installed in the correct location
2-point calibration. and are aligned, the O-rings are in place, and the
spring-loaded latch is closed.
If necessary, remove and install the sensors correctly.
• Check the biosensor contacts and measurement block for
salt buildup.
• Check behind the biosensor for fluid leaks that can come
from the reference sensor.
If salt or leaks are present, clean the sensors with water, dry,
reinstall, and perform a 2-point calibration. Refer to
Performing Manual Calibrations‚ page 3-4.
• If the problem persists, replace the biosensor.
• If the problem persists, call for technical assistance.

D5 Codes

D5 No Endpoint: Ca++
Problem Corrective Action
Sensor does not Correct any reagent problems such as D23 codes before you
reach stable reading attempt to correct this D code.
during predefined • Ensure that the measurement module door was not opened
time limit. during analysis.
The patient sample If door was opened, repeat the sample analysis.
result for the
• Perform a 2-point calibration.
affected sensor is
reported as question Refer to Performing Manual Calibrations‚ page 3-4.
result (-----?). • If a D5 occurs during sample analysis, repeat the sample.
• Deproteinize the sample path and condition the sensors.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• Check the solution level in the affected measurement sensor
and look for bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The pH
and Na+ sensors should be full. If the solution level is low,
refill the sensor.
• If a D5 occurs for more than one sensor, check the solution
level in the reference sensor and look for salt in the vent
hole, and bubbles in the sensor.
• Clean and refill the reference sensor as needed.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-55

Problem Corrective Action


• Check the sensor contacts and measurement block for salt
buildup.
• Check behind the sensors for fluid leaks.
If salt or leaks are present, clean the sensor with water, dry,
reinstall, and perform a 2-point calibration. Refer to
Performing Manual Calibrations‚ page 3-4.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

D5 No Endpoint: Glu Lac


Problem Corrective Action
Sensor does not Correct any reagent problems such as D23 codes before you
reach stable reading attempt to correct this D code.
during predefined • Perform a 2-point calibration.
time limit. Refer to Performing Manual Calibrations‚ page 3-4.
The patient sample
• If a D5 occurs during sample analysis, repeat the sample.
result for the
• If the problem persists, replace the sensor.
affected sensor is
reported as question • If the problem persists, call for technical assistance.
result (-----?).

02087462 Rev. V
6-56 Rapidlab 1200 Operator’s Guide: Troubleshooting

D6 Codes
D6 Excessive Noise: pO2 pCO2
Problem Corrective Action
The sensor signal Correct any reagent problems such as D23 codes before you
has excessive noise. attempt to correct this D code.
The patient sample • Ensure that you did not open or apply pressure to the
result for the measurement module door during analysis.
affected sensor is If you opened or applied pressure to the door during
reported as question analysis, repeat the sample analysis.
result (-----?). • Ensure that you did not apply pressure to the top cover
during analysis.
If you applied pressure to the cover during analysis, repeat
the sample analysis.
• Perform a successful calibration (1-point or 2-point).
• If a D6 for pCO2, with a drift greater than 4.0 mmHg, occurs
twice in a 4-hour period and no drift occurs for pO2,
perform QC analysis.
If the pCO2 result is out of range, replace the sensor.
• If a D6 occurs during sample analysis, repeat the sample.
• Deproteinize the sample path.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-57

D6 Excessive Noise: pH Na+ K+ Ca++ Cl¯


Problem Corrective Action
The sensor signal Correct any reagent problems such as D23 codes before you
has excess noise. attempt to correct this D code.
The patient sample • Ensure that the measurement module door was not opened
result for the during analysis.
affected parameter If door was opened, repeat the sample analysis.
is reported as • Perform a successful calibration (1-point or 2-point).
question result
(-----?). Refer to Performing Manual Calibrations‚ page 3-4.
• If a D6 occurs during sample analysis, repeat the sample.
• Deproteinize the sample path and condition the sensors.
• Refer to Deproteinizing the Sample Path‚ page 5-4.
• Check the solution level in the affected measurement sensor
and look for bubbles.
The K+, Ca++, and Cl¯ sensors should be nearly full. The pH
and Na+ sensors should be full. If the solution level is low,
refill the sensor.
• If a D6 occurs for more than one sensor, check the solution
level in the reference sensor and look for salt in the vent hole
and bubbles in the sensor.
• Clean and refill the reference sensor as needed.
• Check the sensor contacts and measurement block for salt
buildup.
• Check behind the sensors for fluid leaks.
• If salt or leaks are present, clean the sensor with water, dry,
reinstall, and perform a 2-point calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
• If the problem persists, replace the sensor.
• If the problem persists, call for technical assistance.

D6 Excessive Noise: Glu Lac


Problem Corrective Action
The sensor signal Correct any reagent problems such as D23 codes before you
has excess noise. attempt to correct this D code.
The patient sample • Perform a successful 1-point or 2-point calibration.
result for the Refer to Performing Manual Calibrations‚ page 3-4.
affected parameter
• If a D6 occurs during sample analysis, repeat the sample.
is question result
• If the problem persists, replace the sensor.
(-----?).
• If the problem persists, call for technical assistance.

02087462 Rev. V
6-58 Rapidlab 1200 Operator’s Guide: Troubleshooting

D8–D22 Codes
D8 pO2 R Cartridge Error
Problem Corrective Action
The pO2 value • Calibrate the Barometric Sensor. Refer to Calibrating the
during a calibration Barometric Sensor‚ page 5-3
is different than the Perform a full calibration. Refer to Performing Manual
assigned value. Calibrations‚ page 3-4.
• If the pO2 sensor is greater than 6 months old, replace the
sensor.
Perform a full calibration. Refer to Performing Manual
Calibrations‚ page 3-4.
• If the problem persists, replace the reagent cartridge.
Perform a full calibration. Refer to Performing Manual
Calibrations‚ page 3-4.
• If the problem persists, call for technical assistance.

D14 No Sample Detected at FD2


Problem Corrective Action
Fluid detector 2 (FD2) does • Perform a full calibration.
not detect the sample during Refer to Performing Manual Calibrations‚
the predefined time limit. page 3-4.
The sample is discarded and • Repeat sample analysis.
no results are reported. • If the problem persists, call for technical assistance.

D19 Fluid Detector Error: 1, 2, 3


Problem Corrective Action
Fluid detector millivolt • Perform a full calibration.
(mV) reading is beyond Refer to Performing Manual Calibrations‚
predefined limits. page 3-4.
1 FD1 • If the problem persists, call for technical assistance.
2 FD2
3 FD3

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-59

D20 Pressure Signal Out of Range


Problem Corrective Action
The millivolt (mV) 1. Push the spring-loaded latch to the right to relieve excess
reading from the pressure and then press the tab on the latch to release the
pressure sensor is latch.
beyond predefined 2. Select Status > Diagnostics > Fluidic Functions > Wash
limits. Cycle.
3. Check the reference sensor for leaks.
4. If the fill solution is unusually low, replace the reference
sensor cassette.
5. If the problem persists, call for technical assistance.

D21 Processing Error


Problem Corrective Action
An internal 1. Shut the system down.
communication Select Status > Shutdown.
problem between 2. Wait 10 seconds, and then turn the system on.
the system
3. If the problem persists, call for technical assistance.
processors has
occurred.

D22 Barometric Pressure Error


Problem Corrective Action
The barometer 1. Select Status > Calibrate > pAtm.
detects atmospheric 2. Ensure that the reading is stable, within acceptable range,
pressure beyond and is accurate compared to your institution’s barometer.
predefined limits. 3. Calibrate the barometer.
4. If the problem persists, call for technical assistance.

02087462 Rev. V
6-60 Rapidlab 1200 Operator’s Guide: Troubleshooting

D23 Codes
D23 Reagent Flow Error: 2, 10
Problem Corrective Action
Wash reagent was 1. Perform the highlighted test(s) in Diagnostics > Fluidic
not detected during Functions.
calibration. 2. Perform a leak test.
2 FD1 Refer to Performing the Leak Test‚ page 6-37. If the test
10 FD2 fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed.
For Rapidlab 1245 and 1265 systems, verify that the CO-ox
sample chamber is installed correctly.
3. If the problem persists, replace the wash cartridge.
4. If the problem persists, call for technical assistance.

D23 Reagent Flow Error: 3, 11


Problem Corrective Action
200 Cal reagent 1. Perform the highlighted test(s) in Diagnostics > Fluidic
was not detected Functions.
during calibration. 2. Perform a leak test.
3 FD1 Refer to Performing the Leak Test‚ page 6-37. If the test
11 FD2 fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
3. If the problem persists, replace the reagent cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
4. If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-61

D23 Reagent Flow Error: 4, 12


Problem Corrective Action
Slope Cal reagent 1. Perform the highlighted test(s) in Diagnostics > Fluidic
was not detected Functions.
during calibration. 2. Perform a leak test.
4 FD1 Refer to Performing the Leak Test‚ page 6-37. If the test
12 FD2 fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
3. If the problem persists, replace the reagent cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
4. If the problem persists, call for technical assistance.

D23 Reagent Flow Error: 5, 13


Problem Corrective Action
RCx reagent was 1. Perform the highlighted test(s) in Diagnostics > Fluidic
not detected during Functions.
calibration. 2. Perform a leak test.
5 FD1 Refer to Performing the Leak Test‚ page 6-37. If the test
13 FD2 fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
3. If the problem persists, replace the wash cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
4. If the problem persists, call for technical assistance.

02087462 Rev. V
6-62 Rapidlab 1200 Operator’s Guide: Troubleshooting

D23 Reagent Flow Error: 6


Problem Corrective Action
The system detects 1. Perform the highlighted test(s) in Diagnostics > Fluidic
an air leak in the Functions.
fluidic path during 2. Perform a leak test.
a calibration.
Refer to Performing the Leak Test‚ page 6-37. If the test
fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
3. If the problem persists, replace the reagent cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
4. If the problem persists, replace the wash cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
5. If the problem persists, call for technical assistance.

D23 Reagent Flow Error: 7, 8


Problem Corrective Action
Wash fluid was not 1. Perform the highlighted test(s) in Diagnostics > Fluidic
detected during Functions.
wash after a 2. Perform a leak test.
calibration or
Refer to Performing the Leak Test‚ page 6-37. If the test
sample analysis. fails, check the tubing for leaks, and that the tubing is
7 calibration correctly installed in the pinch valve, the O-rings are in
8 sample analysis. place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
3. If the problem persists, replace the wash cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
4. If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-63

D23 Reagent Flow Error: 14


Problem Corrective Action
The system detects 1. Select Diagnostics > Fluidic Functions > RCx and look for
a possible obstructions.
obstruction during 2. Remove obstructions from reagent manifold, measurement
calibration or module, and sample tubing.
during the wash 3. Resolve any other D codes.
cycle after sample
4. Perform the RCx test again.
analysis.
5. Select Diagnostics > Fluidic Functions > Wash Cycle.
6. If the problem persists, replace the wash cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
7. If the problem persists, replace the reagent cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
8. If the problem persists, call for technical assistance.

D24 Codes
D24 AQC Material Error: 1, 2, 3
Problem Corrective Action
An error was 1. Check that the AutomaticQC connector is completely closed
detected during and that the sensors are aligned correctly.
delivery of AQC 2. Select Diagnostics > Fluidic Functions > Prime AQC
material. Cartridge.
1 level 1 The correct button is highlighted.
2 level 2
3. Check if there is an obstruction in the reagent probe
3 level 3
cartridge.
Refer to Flushing the Tubing for the AutomaticQC Module‚
page 5-57.
4. If the problem persists, replace the AutomaticQC cartridge.
NOTE: If you are not able to replace the cartridge, turn off the
AutomaticQC option in Setup to continue analyzing patient
samples.
5. If the problem persists, call for technical assistance.

D32 Codes
D32 AQC Cartridge Valve Error: 1
Problem Corrective Action
A valve does not 1. Select Diagnostics > Pumps and Valves > AQC Valve.
move to the correct 2. If the problem persists, replace the AutomaticQC cartridge.
position. 3. If the problem persists, call for technical assistance.

02087462 Rev. V
6-64 Rapidlab 1200 Operator’s Guide: Troubleshooting

D32 AQC Cartridge Valve Error: 2


Problem Corrective Action
The AutomaticQC 1. Check that the connector is completely open and then select
cartridge fails to Replace to eject the cartridge.
eject. 2. Select Diagnostics > Cartridges > Eject AQC Cartridge.
NOTE: If you are not able to replace the cartridge, in Setup,
turn the AutomaticQC option off to continue analyzing patient
samples.
3. If the problem persists, call for technical assistance.

D33 Codes
D33 R Cartridge Valve Error
Problem Corrective Action
The valve in the 1. Select Diagnostics > Pumps and Valves > R Valve.
reagent cartridge 2. Select Diagnostics > Cartridges > Eject Reagent
fails to move to the Cartridge.
correct position. 3. If the problem persists, replace the reagent cartridge.
4. If the problem persists, call for technical assistance.

D34 Codes
D34 Waste Detector Cal Error: 1
Problem Corrective Action
The waste detector 1. Select Diagnostics > Waste Detector.
is out of range 2. Select Status > Shutdown to shut down the system.
during a system 3. Wait 10 seconds, and then turn the system on.
calibration.
4. If the problem persists, call for technical assistance.

D34 Waste Detector Cal Error: 2, 3


Problem Corrective Action
A full or empty • Select Diagnostics > Waste Detector.
waste bottle was Be sure to insert the waste bottle either full or empty at the
inserted at the appropriate times during the calibration.
wrong time during • If the problem persists, call for technical assistance.
waste bottle
calibration.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-65

D35 Codes
D35 Electronics Error: 1-3, 7-12
Problem Corrective Action
An error has 1. Select Status > Shutdown.
occurred in the 2. Wait 10 seconds, and then turn the system on.
electronic 3. If the problem persists, call for technical assistance.
components.

D35 Electronics Error: 4


Problem Corrective Action
An error has 1. Ensure that the fans are working and nothing is blocking the
occurred in the flow of air.
electronic 2. Inspect the air filters and replace them if required.
components of the 3. Select Status > Shutdown.
heater.
4. Wait 10 seconds, and then turn the system on.
5. Select Diagnostics > Voltage and Temperatures.
6. If the problem persists, call for technical assistance.

D35 Electronics Error: 13


Problem Corrective Action
An error has 1. Select Diagnostics > Pumps and Valves > Sample Pump.
occurred in the 2. Select Status > Shutdown.
electronic 3. Wait 10 seconds, and then turn the system on.
components of the
4. If the problem persists, call for technical assistance.
pump motors.

D36 Codes
D36 Cartridge Loading Error
Problem Corrective Action
The cartridge 1. Ensure that the cartridge is correctly positioned in the door
loader fails to move and nothing is blocking the cartridge from loading.
to the correct NOTE: Use the Eject Reagent Cartridge or Eject Wash
position during Cartridge test depending on the affected cartridge.
reagent or wash 2. Select Diagnostics > Cartridge > Eject W Cartridge or
cartridge removal Eject R Cartridge.
or installation.
3. If the problem persists, replace the cartridge.
4. If the problem persists, call for technical assistance.

02087462 Rev. V
6-66 Rapidlab 1200 Operator’s Guide: Troubleshooting

D37 Codes
D37 Cartridge Eject Error: 1
Problem Corrective Action
The eject 1. Select Diagnostics > Cartridge > Eject W Cartridge and
mechanism fails to Eject R Cartridge.
move to the correct 2. Select Status > Shutdown.
position. 3. Wait 10 seconds, and then turn the system on.
4. If the problem persists, call for technical assistance.

D37 Cartridge Eject Error: 2, 3


Problem Corrective Action
The system fails to 1. Ensure that nothing is blocking the door.
open the cartridge 2. Select Diagnostics > Cartridge > Eject W Cartridge and
door during Eject R Cartridge.
cartridge 3. If the problem persists, call for technical assistance.
replacement.
2 reagent cartridge
3 wash cartridge

D38–D60 Codes
D38 Temp Error: 1-12
Problem Corrective Action
A component in the Check the Gnd sensor and ensure that it is aligned with the
temperature control contacts.
system failed or the If the problem persists, continue with the following:
ambient The system attempts to re-enable the temperature control every
temperature is 15 minutes and re-evaluates the error condition a maximum of 3
beyond the times. This temperature control process can take up to 3.5 hours.
acceptable • To determine the temperatures in the instrument, select
operating Diagnostics > Temperature/pAtm.
conditions.
• Ensure the ambient temperature is within 15° to 32°C.
• Ensure that the front cover is closed.
Wait while the system attempts to correct the problem.
• If the problem persists, select Status > Shutdown.
Wait 10 seconds, and then turn the system on.
• If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-67

D39 Obstruction
Problem Corrective Action
The system detects Correct any reagent problems such as D23 codes before you
an obstruction attempt to correct this D code.
while moving the • Select Diagnostics > Fluidic Functions > RCx.
sample for analysis. • Correct any new D23 problems if they occur.
• Remove obstructions from reagent manifold, measurement
module, CO-ox sample chamber, and sample tubing where
you suspect obstructions.
Refer to Removing Obstructions from the Sample Path‚
page 6-12 and Removing Obstructions from the CO-ox
Sample Path‚ page 6-31.
• Repeat the RCx test to see if obstructions are cleared.
• Select Diagnostics > Fluidic Functions > Wash Cycle.
• If the problem persists, replace the reagent cartridge.
• If the problem persists, call for technical assistance.

D40 W Cartridge Prime Error: 1, 2


Problem Corrective Action
Wash or RCx • Perform the highlighted test(s) in Diagnostics > Fluidic
reagent failed to Functions.
flow from a new • Remove and reinstall the wash cartridge.
wash cartridge. Refer to Ejecting the Wash or Reagent Cartridge‚ page 6-43.
1 wash reagent • Perform a leak test.
2 RCx reagent
Refer to Performing the Leak Test‚ page 6-37. If the test
fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
• If the problem persists, replace the wash cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
• If the problem persists, call for technical assistance.

02087462 Rev. V
6-68 Rapidlab 1200 Operator’s Guide: Troubleshooting

D41 AQC Cartridge Prime Error: 1, 2, 3


Problem Corrective Action
QC material failed 1. Check that the AutomaticQC connector is completely
to flow from a new closed.
AutomaticQC 2. Prime the AutomaticQC cartridge.
cartridge. Refer to Priming the AQC Cartridge‚ page 6-37.
1 level 1
3. Perform a leak test.
2 level 2
3 level 3 Refer to Performing the Leak Test‚ page 6-37.
4. Check if there is an obstruction in the reagent probe
cartridge.
Refer to Flushing the Tubing for the AutomaticQC Module‚
page 5-57.
5. If the problem persists, replace the AutomaticQC cartridge.
NOTE: If you are not able to replace the cartridge, in Setup,
turn the AutomaticQC option off to continue analyzing patient
samples.
6. If the problem persists, call for technical assistance.

D42 R Cartridge Prime Error: 1, 2


Problem Corrective Action
200 cal or slope cal • Perform the highlighted test(s) in Diagnostics > Fluidic
reagent failed to Functions.
flow from a new • Remove and reinstall the reagent cartridge.
reagent cartridge. Refer to Ejecting the Wash or Reagent Cartridge‚ page 6-43.
1 200 cal reagent • Perform a leak test.
2 slope cal reagent
Refer to Performing the Leak Test‚ page 6-37. If the test
fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
• If the problem persists, replace the reagent cartridge.
Perform the highlighted test(s) in Diagnostics > Fluidic
Functions.
• If the problem persists, perform a 2-point calibration.
• If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-69

D50 Glucose Sensor Error


Problem Corrective Action
The system detects 1. Check that the biosensor is correctly installed, the contacts
an open connection are aligned, and the spring-loaded latch is closed.
in the glucose 2. If the biosensor has been on the system less than one day,
biosensor. perform three 2-point calibrations.
Refer to Performing Manual Calibrations‚ page 3-4.
3. If the problem persists, replace the biosensor.
4. If the problem persists, call for technical assistance.

02087462 Rev. V
6-70 Rapidlab 1200 Operator’s Guide: Troubleshooting

D51 Lactate Sensor Error


Problem Corrective Action
The system detects 1. Check that the biosensor is correctly installed, the contacts
an open connection are aligned, and the spring-loaded latch is closed.
in the lactate 2. If the biosensor has been on the system less than one day,
biosensor. perform three 2-point calibrations.
Refer to Performing Manual Calibrations‚ page 3-4.
3. If the problem persists, replace the biosensor.
4. If the problem persists, call for technical assistance.

D60 Communications Error: 1, 2


Problem Corrective Action
The system • Ensure that the cable is firmly connected to the
detects a data Rapidlab 1200 system and to all external devices.
communication • Ensure that the cable is not damaged and that it is the correct
error when trying to cable for connecting the systems.
communicate with • Inspect the cables for wear or crimps.
the Rapidlink or • Ensure that the Rapidlink or Rapidcomm data management
Rapidcomm data system or the LIS is correctly configured to communicate
management with the Rapidlab 1200 system.
system or the LIS.
• Ensure that the Rapidlab 1200 system is correctly
configured to communicate with the Rapidlink or
Rapidcomm system or the LIS and that the connection is
turned on.
• Select Status > Shutdown.
• Wait 10 seconds, and then turn the system on.
• If the problem persists, call for technical assistance.

D70 Codes
D70 Optics Error: 2
Problem Corrective Action
The system fails a 1. Perform a 1-point calibration.
CO-ox optical Refer to Performing Manual Calibrations‚ page 3-4.
clarity test. 2. If the problem persists, replace the CO-ox sample chamber.
3. If the problem persists, call for technical assistance.

D70 Optics Error: 3, 4, 7


Problem Corrective Action
The system detects • Perform a 2-point calibration.
a failure in the Refer to Performing Manual Calibrations‚ page 3-4.
CO-ox optical • Select Diagnostics > CO-ox > Lamp Cal.
components. • If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-71

D70 Optics Error: 9


Problem Corrective Action
The system detects 1. Select Status > Shutdown.
a failure in the 2. Wait 10 seconds, and then turn the system on.
CO-ox optical 3. If the problem persists, call for technical assistance.
components.

D70 Optics Error: 11, 12


Problem Corrective Action
The system detects 1. Perform a full calibration.
a failure in the Refer to Performing Manual Calibrations‚ page 3-4.
CO-ox optical 2. Select Diagnostics > CO-ox > Wavelength Cal.
components.
3. Select Status > Shutdown.
4. Wait 10 seconds, and then turn the system on.
5. If the problem persists, call for technical assistance.

D71–D77 Codes
D71 No Sample Detected at FD3
Problem Corrective Action
Fluid detector 3 • Ensure the sample volume is sufficient for the sample type.
(FD3) does not • Select Diagnostics > Fluidic Functions > RCx.
detect the sample • Look for obstructions or poor flow in the CO-ox sample
during the path.
predefined time • Remove obstructions from the CO-ox sample path:
limit.
If the obstruction is in the CO-ox sample tubing, replace the
CO-ox results are tubing.
not reported. Blood
If the obstruction is in the CO-ox pump tubing or waste
gas, pH, electrolyte,
tubing, remove the obstruction.
and metabolite
• Repeat RCx test to check flow through the sample path.
results are reported.
• Deproteinize the sample path.
Refer to Deproteinizing the Sample Path‚ page 5-4.
• Perform a full calibration.
Refer to Performing Manual Calibrations‚ page 3-4.
• If the problem persists, call for technical assistance.

02087462 Rev. V
6-72 Rapidlab 1200 Operator’s Guide: Troubleshooting

D73 CO-ox Chamber Position Error


Problem Corrective Action
The system detects 1. Ensure that the CO-ox sample chamber is properly installed.
that the CO-ox 2. Select Diagnostics > CO-ox > Sample Chamber Start.
sample chamber is 3. If the problem persists, replace the CO-ox sample chamber.
unable to open or
4. Perform a full calibration.
close correctly.
Refer to Performing Manual Calibrations‚ page 3-4.
5. If the problem persists, call for technical assistance

D75 Lamp Failure


Problem Corrective Action
The system detects 1. Select Diagnostics > CO-ox > Lamp On/Off.
a failure of the 2. If test fails, replace the lamp.
CO-ox lamp. The 3. If the problem persists, call for technical assistance.
lamp has probably
burned out.

D76 CO-ox Electronics Error: 1-10


Problem Corrective Action
The system detects 1. Select Diagnostics > CO-ox > Lamp Cal.
an error in the 2. Select Status > Shutdown.
CO-ox electronics 3. Wait 10 seconds, and then turn the system on.
system.
4. If the problem persists, call for technical assistance.

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


Problem Corrective Action
A component in the The system attempts to re-enable the temperature control every
temperature control 15 minutes and re-evaluates the error condition a maximum of 3
system failed or the times. This temperature control process can take up to 3.5 hours.
ambient • To determine the temperatures in the instrument, select
temperature is Diagnostics > Temperature/pAtm.
beyond the • Ensure the ambient temperature is within 15° to 32°C.
acceptable
• Ensure that the front cover is closed.
operating
conditions. Wait while the system attempts to correct the problem.
• If the problem persists, select Status > Shutdown.
Wait 10 seconds, and then turn the system on.
• If the problem persists, call for technical assistance.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-73

D78 Codes
D78 No Reagent Detected at CO-ox: 1
Problem Corrective Action
Fluid detector 3 • Perform the highlighted test(s) in Diagnostics > Fluidic
(FD3), the CO-ox Functions.
sample chamber, or • If the problem persists, select Diagnostics > Fluidic
both do not detect Functions > RCx and look for obstructions in the CO-ox
wash reagent sample path.
during a Remove obstructions.
calibration. • Repeat the RCx test to check flow through the CO-ox
sample path.
• Perform a leak test.
Refer to Performing the Leak Test‚ page 6-37. If the test
fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For
Rapidlab 1245 and 1265 systems, verify that the CO-ox
sample chamber is installed correctly.
• If no other D codes occur, replace the CO-ox sample
chamber.
• If the problem persists, call for technical assistance.

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


Problem Corrective Action
Fluid detector 3 • Perform the highlighted test(s) in Diagnostics > Fluidic
(FD3), the CO-ox Functions.
sample chamber, or • If the problem persists, select Diagnostics > Fluidic
both do not detect Functions > RCx and look for obstructions in the CO-ox
wash reagent sample path.
during a wash Remove obstructions.
cycle. • Repeat the RCx test to check flow through the CO-ox
2 after calibration sample path.
3 after sample • Perform a leak test.
Refer to Performing the Leak Test‚ page 6-37. If the test
fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
• If no other D codes occur, replace the CO-ox sample
chamber.
• If the problem persists, call for technical assistance.

02087462 Rev. V
6-74 Rapidlab 1200 Operator’s Guide: Troubleshooting

D78 No Reagent Detected at CO-ox: 4


Problem Corrective Action
Fluid detector 3 • Perform the highlighted test(s) in Diagnostics > Fluidic
(FD3), the CO-ox Functions.
sample chamber, or • Remove obstructions.
both do not detect • Repeat the RCx test to check flow through the sample path.
RCx reagent during • Perform a leak test.
a calibration.
Refer to Performing the Leak Test‚ page 6-37. If the test
fails, check the tubing for leaks, and that the tubing is
correctly installed in the pinch valve, the O-rings are in
place, and the spring-loaded latch is closed. For Rapidlab
1245 and 1265 systems, verify that the CO-ox sample
chamber is installed correctly.
• If no other D codes occur, replace the CO-ox sample
chamber.
• If the problem persists, call for technical assistance.

Viewing System Messages


The system displays messages in the events log at the Status screen or in the Recall menu.
For example, after you replace an expired wash cartridge, the message about the cartridge
no longer displays at the Status screen. It does remain in the events log and you can access
it from the Recall menu. For quick access to information about system messages, select
Help.

The following table lists the messages in alphabetical order.


Message Probable Cause Corrective Action
AQC Cartridge The AutomaticQC cartridge has Replace the cartridge. Refer to
Expired exceeded its operating life or is Replacing the AutomaticQC
depleted. Cartridge‚ page 2-3.
To continue analyzing patient
samples if you are not able to
replace the cartridge, turn off the
AutomaticQC option in Setup.
For information about setting up
the AutomaticQC options, refer
to Setting up AutomaticQC
Schedule‚ page 8-5.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-75

Message Probable Cause Corrective Action


AQC Cartridge The system detects that the newly Replace the cartridge. Refer to
Not Valid installed AutomaticQC cartridge Replacing the AutomaticQC
has exceeded its expiration date, Cartridge‚ page 2-3.
that a used cartridge was To continue analyzing patient
reinstalled, or that the cartridge samples if you are not able to
was installed without starting replace the cartridge, turn off the
from the Status screen. AutomaticQC option in Setup.
For information about setting up
the AutomaticQC options, refer
to Setting up AutomaticQC
Schedule‚ page 8-5.
AQC The system detects that the Slide the connector to the left to
Connector is connector on the AutomaticQC close it.
Open cartridge is open.
Additional Cal A sensor experienced a This message is displayed in the
Required calibration error and the system printed report.
repeated the calibration to correct
the error.
Additional 1. Wash reagent fails Optical A change in transmittance was
Wash Required Clarity Test. detected after a CO-ox sample
2. Operator Error: sample analysis. The system repeated the
device is not removed before wash to attempt to correct the
sample endpoints. error.
If the repeated wash fails again,
the system displays a D70
Optical Error: 2 message.
The sample device was not
removed before the sample
endpoints.
Bubbles in Bubbles in the sample can occur If the system detects bubbles
Sample if the sample contained bubbles before measurement begins, it
or if you introduce the jagged end prompts you to analyze the
of capillary tubes into the sample sample as a microsample.
port. The message displays on If the system detects bubbles
the printed report. during sample measurement, it
prompts you to inspect the
sample for bubbles and
determine whether to complete
the analysis and report results, or
cancel analysis.

02087462 Rev. V
6-76 Rapidlab 1200 Operator’s Guide: Troubleshooting

Message Probable Cause Corrective Action


To avoid bubbles in patient
samples, ensure that you use the
recommended collection,
storage, handling, and mixing
techniques. Refer to Collecting
Samples‚ page 2-7.
For QC samples, ensure that you
use the storage and handling
techniques recommended by the
manufacturer.
1. Analyze the sample again,
ensuring that the sample has
no bubbles before
introducing it into the
sample port.
Checking for bubbles is
especially important for
samples introduced from
capillary tubes.
2. If you are analyzing a
capillary sample, ensure that
you insert the (smooth) end
of the capillary tube into the
sample port.
Cal Not Done The system was unable to This occurs if the system is left
perform a calibration. idle in a state where it cannot
perform calibrations, such as the
following times:
• the waste is full
• cartridges are expired
• while in Maintenance and
Diagnostics
• when the system is not ready
Cal Overdue Calibration was delayed beyond The system must perform a
the maximum calibration calibration before you can
interval. analyze samples.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-77

Message Probable Cause Corrective Action


CO-ox The system detects that the Ensure that you installed the
Chamber Temp temperature of the CO-ox sample CO-ox sample chamber properly.
Error chamber is beyond the acceptable Ensure that you tightly close the
range. front cover.
This message occurs when a new The system clears the message
sample chamber is warming up when the system reaches normal
or when the system is warming operating temperature.
up after being shut down.
Results for tHb are reported
while this message appears. The
system also displays the message
on the printed report.
CO-ox Sample The CO-ox sample chamber has Replace the CO-ox sample
Chamber exceeded its shelf life or chamber.
Expired operating life.
CO-ox Sample The system does not detect the This usually indicates that the
Chamber Not CO-ox sample chamber. sample chamber was removed
Detected without using the correct
Maintenance procedure.
If you are replacing the sample
chamber, install the new sample
chamber. Refer to Replacing the
CO-ox Sample Chamber‚
page 5-9.
Ensure the tabs on each side are
locked in place.
CO-ox Sample The system detects that the This usually indicates that the
Temp Out of temperature of the CO-ox sample sample was analyzed before the
Range chamber is beyond the acceptable acceptable sample range was
range at the end of analysis. reached.
The system does not report tHb
results. The message displays on
the printed report.
Ensure that you installed the
CO-ox sample chamber properly.
Ensure that you tightly close the
front cover.
Wait until the system removes
the message from the events log
before analyzing samples.

02087462 Rev. V
6-78 Rapidlab 1200 Operator’s Guide: Troubleshooting

Message Probable Cause Corrective Action


Excessive The system detects bubbles in the This occurs if the sample
Bubbles in CO-ox sample chamber. contained bubbles, if air leaks are
CO-ox Sample present in the CO-ox sample
tubing, or if you inserted the
jagged end of capillary tubes into
the sample port.
CO-ox results are not reported.
Results for other enabled
parameters are reported.
1. Ensure that you use the
recommended storage,
handling, and mixing
techniques.
Refer to Collecting Samples‚
page 2-7. For QC samples,
use the storage and handling
techniques recommended by
the manufacturer.
2. Analyze the sample again,
ensuring that the sample has
no bubbles before
introducing it into the
sample port. Checking for
bubbles is especially
important for samples
introduced from capillary
tubes.
3. Check the CO-ox sample
tubing for cracks or leaks.
4. When analyzing a capillary
sample, ensure that you
introduce the smooth end of
the capillary tube into the
sample port.
Insufficient The system detects that not For patient samples, the system
Sample enough sample volume exists to prompts you to analyze the
complete routine analysis. sample as a microsample. When
This is caused when you remove this happens, CO-ox results are
the sample device from the not reported and QC samples are
sample port before aspiration discarded and no results are
completes or by low volume reported.
samples.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-79

Message Probable Cause Corrective Action


Ensure that the sample device
you use contains sufficient
sample. To identify the minimum
sample volume for the sample
device that you are using, refer to
Recommended Fill Volumes‚
page C-1.
Interfering The system detects the presence The symbol # displays next to the
Substance of substances in the sample that results.
may interfere with measurement. Check the sample source and
result, and ascertain the source of
an interfering substance.
Repeated, unexpected
occurrences of this message may
indicate sensor failure. Replace
the sensor.
Measurement The system detects that the 1. Close the measurement
Module Door measurement module door was module door firmly and
Opened opened without first accessing ensure both latches are
the Diagnostics or Maintenance locked in place.
screen. 2. Respond to the prompt, “Did
If this occurred during sample you remove or replace any
analysis, the message is printed sensors?”
with the report. The system starts
accelerated calibration
intervals in either of 2
instances:
• You select Yes.
• You select No but the
system detects a drop in
pressure in the sample
path, which indicates a
sensor was removed.
Microsample The system detects that the Confirm sample results.
Question Value sample is a microsample because
of bubbles or insufficient sample.
The message is printed with the
sample analysis report, and
transmitted to the LIS, or
Rapidlink or Rapidcomm Data
Management systems. This
message occurs only if Flag
Microsamples is enabled in
Setup.

02087462 Rev. V
6-80 Rapidlab 1200 Operator’s Guide: Troubleshooting

Message Probable Cause Corrective Action


No AQC The system does not detect the If the AutomaticQC cartridge
Cartridge AutomaticQC cartridge after was just installed, the cartridge
replacing the cartridge or at may not be installed correctly or
power up. it could be a system problem.
Replace the AutomaticQC
cartridge as described Replacing
the AutomaticQC Cartridge‚
page 2-3.
If you are not able to replace the
cartridge, continue running
patient samples with the
AutomaticQC turned off. For
information about AutomaticQC
Options, refer to Setting up
AutomaticQC Schedule‚
page 8-5.
No Paper in The printer is out of paper. Install a new roll of paper.
Printer Refer to Replacing the Printer
Paper‚ page 5-42.
If necessary, use the Recall menu
to locate and print results or data
that were not printed while the
printer was out of paper.
No Printer You selected the external printer Configure Windows with a
Configured for a printout but you have not default printer.
configured Microsoft Windows
with a default external printer.
No R Cartridge The system does not detect the The cartridge may not be
reagent cartridge. installed correctly.
Reinstall the cartridge.
Replace the reagent cartridge.
Refer to Replacing the Reagent
Cartridge‚ page 2-3.
No Sample The system is unable to detect a This may be caused if you do not
Detected sample at FD1. insert a sample device before
starting sample analysis, by air
leaks in tubing, or if tubing is
disconnected.
Check tubing connections and
check for leaks in the sample
tubing.
No Waste The system does not detect the Place the waste bottle on the
Bottle waste bottle. system.
Detected Refer to Emptying the Waste
Bottle‚ page 2-2

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-81

Message Probable Cause Corrective Action


No W The system does not detect the Reinstall the cartridge.
Cartridge wash cartridge. The cartridge Replace the cartridge. Refer to
may not be installed correctly. Replacing the Wash Cartridge‚
page 2-2.
Out of The parameter shown in the The appropriate symbol, -----↑ or
Reporting message is above or below the -----↓, displays on the results
Range valid measurement range for screen and on the report.
calibrations, QC, or patient
samples.
Parameter The system has turned on N/A
Restored parameters that were turned off
because they failed QC analysis
or because the scheduled analysis
was not performed.
QC Failed The specified parameters failed Perform a 2-point or full
QC. The sensor may have drifted calibration. Refer to Performing
since the last automatic Manual Calibrations‚ page 3-4.
calibration. Follow the storage and handling
The control may not have been requirements provided by the
stored or handled correctly. manufacturer for the control.
Perform QC analysis again.
QC Lot Not Controls are currently scheduled Define a new lot of the controls.
Defined for Required QC analysis, but no Refer to Setting up Required QC
lot information is entered for the Ranges‚ page 8-4 and then
controls. analyze the scheduled controls.
QC Material Controls are currently scheduled Define a new lot of the controls.
Expired for Required QC analysis, but the Refer to Setting up Required QC
lot has expired for the controls. Ranges‚ page 8-4 and then
analyze the scheduled controls.
QC Missed The grace period expired and Perform the Required QC. Refer
Required QC has not been run. to Performing Required QC
Sample Analysis‚ page 4-1.
Question The system detected an atypical Analyze the sample again to
Result response when measuring the verify the result.
parameter identified in the
message.
The system does not report
results. The symbol, -----? is
displayed next to the parameter
name on the Results screen and
on the report.
R Cartridge The reagent cartridge has Replace the cartridge. Refer to
Expired exceeded its shelf life or its Replacing the Reagent
operating life, or is depleted. Cartridge‚ page 2-3.

02087462 Rev. V
6-82 Rapidlab 1200 Operator’s Guide: Troubleshooting

Message Probable Cause Corrective Action


R Cartridge The system detects that an Replace the cartridge. Refer to
Not Valid expired reagent cartridge was Replacing the Reagent
installed or the cartridge was Cartridge‚ page 2-3.
installed after being removed for
more than 6 hours.
The system is unable to use the
cartridge.
Sample Temp The system detects that the Check that the front cover is
Out of Range temperature of the patient or QC closed tightly.
sample is beyond the acceptable Analyze the sample again.
measurement range at the end of
sample analysis.
The system reports the sample
results. The message displays on
the printed report.
Scheduled QC AutomaticQC or Required QC The system performs
Not Done was not performed when AutomaticQC analysis for
(Level 1, 2, or scheduled. missed QC when the system
3) becomes available.
Perform Required QC analysis,
or restore parameters.
SulfHb > 1.5% The system detects a The message displays on the
sulfhemoglobin concentration printed report.
greater than 1.5% in the sample.

Temp Not The temperature of the This message can occur when the
Ready measurement module is beyond system is warming up after being
the acceptable measurement shut down or when the door
range. remains open for too long.
Ensure that you closed the front
cover securely.
Wait until the system removes
the message from the events log
before analyzing samples.
Temp Warning The system detects that the This message can occur when the
temperature of the measurement system is warming up after being
module is beyond the specified shut down or when the door
range for sample analysis. remains open for too long.
Ensure that you closed the front
cover securely.
Wait until the system removes
the message from the events log
before analyzing samples.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Troubleshooting 6-83

Message Probable Cause Corrective Action


User Canceled The operator interrupted a No action necessary.
Calibration calibration to perform another
action, for example to load a
STAT test.
W Cartridge The wash cartridge has exceeded Replace the cartridge. Refer to
Expired its operating life or is depleted. Replacing the Wash Cartridge‚
page 2-2.
W Cartridge An expired wash cartridge was The system is unable to use the
Not Valid installed or the cartridge was cartridge.
installed after being removed for Replace the cartridge. Refer to
more than 6 hours. Replacing the Wash Cartridge‚
page 2-2.
Waste Full The waste bottle is full and can Replace the waste bottle. Refer to
no longer accept waste. Emptying the Waste Bottle‚
page 2-2.
Waste is The waste bottle is Replace the waste bottle. Refer to
Almost Full approximately 70% full. Emptying the Waste Bottle‚
page 2-2.
You can replace the waste bottle
now or wait until the system
prompts you.

02087462 Rev. V
6-84 Rapidlab 1200 Operator’s Guide: Troubleshooting

02087462 Rev. V
7 File Management

This section contains information about the following file management topics:
• File names and formats
• Copying data files
• Viewing the sample totals

File Names and Formats


When you copy files to a storage medium, CD or diskette, the file name indicates
the type of data the file contains (P for patient, Q for QC, and C for calibration)
and the day of the year that the file was created. For example, file P15.CSV
contains patient data and was created on January 15 and file Q46.CSV contains
QC data and was created on February 15, the 46th day of the year.
The diskette data files are in CSV format and the CD data files are in CSF format.
Both of these formats use a comma-delimited record structure. The files contain
ASCII characters without any character formatting. For example, the system uses
the following means of displaying the results:
• pCO2 is displayed as pCO2
• the letter H in the column next to a result instead of ↑ to indicate that the
result is above the patient range
• the letter L instead of ↓ to indicate that the result is below the patient range
When a result is above or below the reporting range, the system does not display a
value. The system displays only the letter H or L to indicate that the result is
above or below the reporting range.
In each patient and QC file, the data is organized in rows:
Row Contents
1 The first row contains column headings. The files containing
patient data include columns for demographic fields, parameter
names, and patient ranges.
The files containing QC data include columns for lot information
and target ranges as well as parameter names.
The system displays columns for parameters, ranges, and
demographics even if you do not enable them in Setup.
2 The second row contains units of measure for the demographics
and parameters.

02087462 Rev. V
7-2 Rapidlab 1200 Operator’s Guide: File Management

Row Contents
3 through the end The remaining rows contain the values for each record in the file.
of the file Each record contains results for a single sample analysis. The
records are sorted by date, beginning with the most recently
saved data.
In each calibration file, the data is organized in rows:
Row Contents
1 and 2 The first 2 rows contain column headings. The data includes
columns for 1-point and 2-point calibrations. The system
reserves the last columns for system messages associated with
results.
3 The third row contains units of measure.
4 through the end The remaining rows contain the values for each record in the file.
of the file Each record contains results for 1 calibration. The system sorts
records by date, beginning with the most recently saved data.

Copying Data Files


Use this procedure to copy the following types of data to a diskette or CD:
• patient, QC, or Calibration data
• diagnostic data
Copying the data to a diskette or CD allows you to import the data into other programs
that accept the CSV or CSF file format. Such programs can include spreadsheet or
database programs that you use for data analysis or management. For more information
about how the data is stored in the files, refer to File Names and Formats‚ page 7-1.
The system copies all records to a diskette or CD. If you analyze up to 30 samples per day
and want to maintain copies of all the data, perform this procedure at least once a week.
Copy the data more frequently if you analyze more than 30 patient samples per day.
The system maintains 5000 records of patient and QC samples, and 2000 records of
calibrations on its internal hard disk. When the system is at the maximum number of
records, the system deletes the oldest records to accommodate the new data.
You need either blank 1.44 MB 3.5-inch diskettes, IBM format or a CD-RW.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: File Management 7-3

Copying Patient, QC, or Calibration Data Files


1. Select Recall > Copy Stored Results.
NOTE: The system displays the date for the last time you copied data to the
left of the buttons.
2. Select the type of data you want to copy, Patient, QC, or Calibrations.
3. Select the type of data storage you are using, CD or diskette.
4. Insert the diskette or CD into the appropriate drive:
If you selected... Then...
Diskette, The number of diskettes required is displayed on the screen.
a. When prompted, remove the diskette from the drive and
insert the next diskette in the sequence.
b. Select Continue.
c. Continue removing and inserting diskettes, as prompted.
d. When prompted, remove the last diskette from the drive and
select Continue.
CD, a. When prompted, insert the CD into the drive and select
Continue.
b. When prompted, remove the CD from the drive and select
Continue.

5. Store the diskettes or CD in a safe place, away from heat and strong magnetic
sources such as centrifuges.

Copying Diagnostic Data


Use this procedure to copy diagnostic data to a diskette, CD, or to a remote site
using a network connection. To copy data through a network connection you must
configure your system for a network, and connect it to a device that provides
access to the remote site.
The system stores data for each day including the current day and the previous 29
days.
1. Select Recall > Copy Stored Results > System Data.
2. Select the data or log information to copy.
To copy... Then...
wash cartridge information, select Wash.
reagent cartridge information, select Reagent.
AutomaticQC cartridge information, select AQC.
summary data for the database, select Summary.
data for a single day, select the date.
log information for a single day, select the date and then select Logs Only.

02087462 Rev. V
7-4 Rapidlab 1200 Operator’s Guide: File Management

3. Copy the data:


If you are
copying data... Then...
to CD, a. Select CD.
b. When prompted, insert the CD into the drive and select
Continue.
c. When prompted, remove the CD from the drive and select
Continue.
d. Select Return.
to email, a. Select Email.
When the system finishes copying data, the system displays
the System Data screen.
b. Select Return.
to diskettes, a. Select Diskettes.
b. When prompted, insert the first diskette into the drive and
select Continue.
The system displays the number of diskettes required on the
screen.
c. When prompted, remove the diskette from the drive, insert
the next diskette in the sequence, and select Continue.
d. Continue removing and inserting diskettes as prompted.
e. Select Return.

Viewing the Sample Totals


Sample totals include the following information:
• Total number of patient analyses and QC analyses (from QC samples that are not
barcoded) for the system
• Number of patient analyses for each parameter
The system does not include Required QC samples, AutomaticQC samples, and any other
QC samples that are barcoded in the sample totals.
Use the following steps to view the sample totals:
1. Select Recall > Sample Totals.
2. You can select Print to print the sample totals.
3. Select Return.

02087462 Rev. V
8 System Configuration

Use this section to modify the system configuration options on the Setup menu.
The Setup menu contains the options for customizing the analysis and reporting
characteristics of your Rapidlab 1200 system.
After you customize any of these settings you can select another Setup option or
save the setup data. Refer to Saving and Restoring System Setup Data‚ page 8-41.
To access the Setup screen, perform the following steps:
1. At the user interface, select Status > Setup.
You can select a setup button on the left of the screen to display the setup
options to configure that system function.
2. Select the function type on the left of the screen.
3. Select the function option on the right side of the screen.
4. Enter your password, if necessary.
Refer to Using Basic System Functions‚ page 2-1.
5. Perform the task according to the instructions in this section.
6. Save the Setup data to a diskette or CD each time you change system
configuration.
Refer to Saving and Restoring System Setup Data‚ page 8-41.

Using the Setup Menu


The following table lists the Setup options and identifies the buttons on the Setup
menu that you select to access each option.
If you want to... Select...
setup QC ranges, schedule, AutomaticQC, and High G/L, QC
enter ranges, patient or sample demographic information, allow Sample
parameter selection at the Analysis screen, select sample type,
enable or disable parameters, set up units of measure, demographic Parameters
units,
select the language and the date format, adjust the sound, and enter a System
system name, Options

setup the printer settings, configure the barcode information, or turn Printer and
on communications to a data management system or LIS, Devices

set security, setup system analysis functions, backup and restore setup Secured
configuration, and install software upgrades, Options

02087462 Rev. V
8-2 Rapidlab 1200 Operator’s Guide: System Configuration

Setting up QC
When you select QC at the Setup screen, the following options are available:
• QC Options
• Required QC Schedule
• Required QC Ranges
• AutomaticQC Schedule
• AutomaticQC Ranges
• High G/L

Setting Up QC Options
Use the QC Options screen to enable or disable a QC option, enable or disable syringe QC,
require Operator identification, and select a method for QC range checking.
1. At the Setup screen, select QC Options.
2. At the QC options screen, select a performance option:
If you want... Select...
to perform QC sample analysis on an as needed basis, Unscheduled QC.
to require operators to perform QC sample analysis Required QC.
according to a schedule,
the system to perform QC samples as scheduled in QC AutomaticQC.
Setup,
3. If you select AutomaticQC and you want all failed AutomaticQC samples to repeat,
select Repeat.
4. Select the syringe QC button to enable syringe QC samples.
5. At the area labeled Required Field, select Operator ID to display the operator
identification screen when an operator is analyzing QC samples.
6. To make the Operator ID a requirement, select the Required button.
7. Select a QC Range Checking Methodology:
If you want to... Select...
use the manufacturer’s low and high ranges for QC range Low, High.
checking,
to perform RiliBÄK analysis (does not apply to CO-ox RiliBÄK
fractions),
If you want to customize ranges, follow the procedure in the next section, Entering
Customized QC Range Limits‚ page 8-3.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-3

Entering Customized QC Range Limits


1. At the Setup screen, select QC.
2. If performing AQC, select AutomaticQC Ranges.
If performing RQC, select Required QC Ranges.
3. Select the QC range to view.
The screen for the QC range you selected displays.
4. Select a parameter.
5. Enter a low limit, a high limit, or both, in the Low and High boxes, for the
selected parameter.
If in RiliBÄK mode, use the following equations to determine low and high
values:
• Range Offset from Manufacturing Target =
Manufacturing Target + (Manufacturing Target * Desired Deviation from
Target)
• QC Low Value =
(Manufacturing Target – Range Offset from Manufacturing Target)
• QC High Value =
(Manufacturing Target + Range Offset from Manufacturing Target)
6. Repeat steps 4-5 as needed, for additional parameters.
7. Select Continue.

Setting Up Required QC
Use the Required QC screen to set up a required QC sample schedule. Use the
barcode scanner and RapidQC controls to perform Required QC analysis.
NOTE: Ensure that you enter information for each lot of the controls you
schedule. Refer to Setting up Required QC Ranges‚ page 8-4. You cannot analyze
the scheduled controls until you enter the lot information.
1. At the Setup screen, select QC > Required QC Schedule.
The screen displays the Required QC Schedule with the current schedule for
Required QC analysis, if defined.
NOTE: When you change intervals, the system clears any times and levels
that were previously scheduled.
2. Select Intervals.
The system displays the Intervals screen.
3. Select the number of hours for the interval of the Required QC analysis.
For example, select 8 to have an 8-hour window for performing scheduled
controls.

02087462 Rev. V
8-4 Rapidlab 1200 Operator’s Guide: System Configuration

4. Select Save.
The Intervals screen closes.
5. Schedule levels for each time and day, as necessary:
a. Use the arrow keys to navigate to a place in the grid indicating the day of the week
and time period for the level or levels.
b. Select one or more buttons for the level or levels to schedule.
A check mark on the button means that you scheduled that level. Select the button
again to remove the check mark.

Setting up Required QC Ranges


Use this screen to enter the following information for the controls you use for Required
QC analysis:
• Control name
• Lot number
• Expiration date
• Target ranges for each level
Required QC ranges support both an active and trial lot. Only the active lot is used to
satisfy the Required QC schedule. The trial lot is used to evaluate new materials.
To define the schedule your system uses for automatically analyzing controls, refer to
Setting up AutomaticQC Schedule‚ page 8-5.
1. At the Setup screen, select QC > Required QC Ranges.
NOTE: When you scan a lot for a level, it becomes the active lot. If you already have
an active lot for a level and scan in new lot information for the same level, it becomes
the trial lot.
When you scan the barcode, the system makes the button corresponding to that level
available. If a level button is available, that barcode is already scanned.
2. Scan the catalog number barcode on the QC Expected Values chart.
When you scan the barcode for a new lot of controls, the system displays a message
prompting you to keep the existing target ranges.
3. Scan the lot number barcode for a level of the control on the QC Expected Values
chart.
This displays the Range Entry screen. This screen displays the control name, level, lot
number, and expiration date under the banner portion of the screen. It also displays the
parameters and their ranges and allows you to edit the ranges. Refer to Editing
Required QC Ranges‚ page 8-5.
4. At the Range Entry screen, scan the barcode for each parameter to enter the target
ranges for this level.
5. Select Save.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-5

6. At the Required QC Ranges screen, select Save to return to the Setup menu.

Editing Required QC Ranges


You can change the range values of each parameter in the selected level. You can
also convert a trial lot to an active lot.
1. At the Setup screen, select QC > Required QC Ranges.
2. Select an available level button to view or edit the ranges for that level:
Selecting the level button displays the Range Entry screen displaying the
ranges defined for each parameter for that level.
3. Select the parameter you want to edit and then select Low or High.
4. To clear the field, select Clear.
5. Use the numeric buttons to enter new range values.
6. Repeat steps 3 through 5 for each parameter you need to edit.
7. If the parameter is a trial lot and it should be an active lot, select Set Active.
The Set Active button is only displayed when the lot is a trial lot.
8. Use the print button to print the values selected for this level.
9. Select Save.

Setting up AutomaticQC Schedule


Use this screen to select the days and times for AutomaticQC analysis and select
the controls to analyze at the scheduled times.
1. At the Setup screen, select QC > AutomaticQC Schedule.
If a schedule is already defined, the AutomaticQC Schedule screen displays
the currently defined schedule.
2. Select each button for the level you want to schedule.
a. Use the arrow keys to navigate to a place in the grid indicating the day of
the week and time period for the level or levels.
b. Select one or more buttons for the level or levels to schedule.
A check mark on the button means that you scheduled that level. Select
the button again to remove the check mark.
3. Turn AutomaticQC analysis on:
a. Select QC > QC Options > AutomaticQC.
b. Select Repeat if you want the system to repeat QC analysis when a
parameter fails the first analysis.
c. Select Save.

02087462 Rev. V
8-6 Rapidlab 1200 Operator’s Guide: System Configuration

Setting up AutomaticQC Ranges


Use the AutomaticQC ranges screen to view lot information and target ranges for controls
used for AutomaticQC analysis.
When you replace the AutomaticQC cartridge, the system replaces the current target
ranges with its own target ranges. If you want to retain the ranges that you defined,
perform the following steps. You can also use this procedure to change target ranges back
to the recommended default ranges.
1. At the Setup screen, select QC > AutomaticQC Ranges.
If your system is connected to a data management system or an LIS and you select an
option that changes target ranges, be sure to change target ranges at the data
management system or LIS.
2. Keep or change the target ranges.
If you want to... then...
keep the target ranges you defined select Retain Ranges.
for AutomaticQC,
change the target ranges back to the a. Deselect Retain Ranges to turn the option
recommended default ranges, off.
b. Select Reset Defaults.
3. Select Save.

Setting up High G/L QC Options


Use this screen to configure demographic data entry fields for High G/L samples. During
analysis, the system can require the operator to enter selected demographic information
for High G/L samples.
NOTE: If both Glucose and Lactate are turned off in Setup, the Analysis screen does not
display the High G/L option.
1. At the Setup screen, select QC > High G/L.
2. Select either or both of the demographics you want entered when performing
High G/L samples.
• If you want the operator to enter their identification when performing a High G/L
test, select Operator ID.
• If you want the operator to enter the lot number of the control when performing a
High G/L Test, select Lot Number.
3. Select the Required button to make the selected demographic required.
When you select Required next to either or both of the test demographic buttons, the
operator must enter the corresponding demographic before leaving the screen.
4. Select Save.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-7

Setting up Sample Information


Select the Sample button to display options for the following setup screens:
• Patient Ranges
• Patient Demographics
• Sample Demographics
• Parameter Selection
• Sample Type

Defining Patient Ranges


Use this procedure to define the high and low limits of the patient range for each
parameter. The system identifies patient results that are above or below the range
that you define. If you do not define a patient range, the system identifies results
outside the reporting range.
1. At the Setup screen, select Sample > Patient Ranges.
2. Use the arrows at the left of the screen to select a parameter.
3. Use the Low button or High button to enter the low limit and the high limit for
each parameter, as needed.
a. Select Low.
b. Use the keypad to enter the value in the Low field.
c. Select High.
d. Use the keypad to enter the value in the High field.
4. Select Save.

Using Default Ranges


The following table lists the default range for each parameter and the default unit
of measure. The default ranges are the valid reporting ranges for the parameters. If
you select alternate units, the system automatically converts the ranges to the
corresponding values for the selected units.
Parameter Default Range Default Units
pH 6.000–8.000 (pH units)
pCO2 5.0–250.0 mmHg
pO2 0.0–800.0 mmHg

Na+* 70.0–200.0 mmol/L

K+* 0.50–20.00 mmol/L

Ca++* 0.25–5.00 mmol/L

Cl¯* 40–160 mmol/L

02087462 Rev. V
8-8 Rapidlab 1200 Operator’s Guide: System Configuration

Parameter Default Range Default Units


Glu * 10–998 mg/dL

Lac* 0.00–30.00 mmol/L

tHb† 2.0–25.0 g/dL

FO2Hb† 0.0 ± 200.0 (QC ranges) %

FO2Hb† 0.0 ± 100.0 (patient ranges) %

FCOHb† 0.0 ± 200.0 %

FMetHb† 0.0 ± 200.0 %

FHHb† 0.0 ± 200.0 %

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

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-9

Setting up Patient Demographics or Sample


Demographics
At the Patient Demographics or Sample Demographics screen you can select the
following options:
• Required entries
Use this option to set up the demographic fields to use at the Data Entry
screen.
• Rapid Sample Identification
Select this option to allow the system to use the patient ID to search for
matching patient information in remote databases such as Rapidlink,
Rapidcomm, or an LIS.
• Default value for the century entered for the date of birth
• Allow alphanumeric characters for use in the Patient ID field

Using Patient and Sample Demographics


The following table lists the patient and sample demographics that you can select.
When you enter a patient ID for an existing patient, the system populates the
patient data from stored patient information. When you modify patient
information, the system updates this information in all samples that use this
patient ID.
Patient Demographics Sample Demographics
Patient ID Location
Last Name Physician ID
First Name Draw Date
Sex Draw Time
Date of Birth Accession No.
Operator ID
Temperature
tHb
F I O2
Flow
Resp. Rate

NOTE: If you turn off a sample demographic that is necessary to determine


results, the system also turns off any parameters that require that sample
demographic. To identify the demographics needed to report results, refer to
Setting up Parameters‚ page 8-13.

02087462 Rev. V
8-10 Rapidlab 1200 Operator’s Guide: System Configuration

Defining Patient Demographics


1. At the Setup screen, select Sample > Patient Demographics.
2. Select each demographic to turn it on or off.
3. Select the Required button to make the selected demographic required.
When you select the Required next to either or both of the test demographic buttons,
the operator must enter the corresponding demographic before leaving the screen.
4. To use the patient ID to search for matching patient information in a connected data
management system or LIS, select Rapid Sample Identification.
5. To change the century that is entered in the Date of Birth field, select 20XX.
6. To use alphanumeric characters for the Patient ID field, select Keyboard.
The default option for patient ID is numeric entry only.
7. Select Save.

Defining Sample Demographics


1. At the Setup screen, select Sample > Sample Demographics.
2. Select each demographic button, as necessary, to turn it on or off.
Buttons that have a white background and a check mark are turned on.
3. Select the Required button to make the selected demographic required.
When you select the Required next to either or both of the test demographic buttons,
the operator must enter the corresponding demographic before leaving the screen.
4. Select Save.

Setting up Parameter Selection at Analysis


Use the Parameter Selection at Analysis screen to perform the following functions:
• enable parameter selection when you are at the Analysis screen
• define up to two sets of three custom panels

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-11

Enabling Parameter Selection at Analysis


The Parameter Selection option allows you to turn selected parameters off at the
Analysis screen. For example, if blood gas and electrolyte parameters are selected
and you want to measure only blood gas parameters, you can turn all the
electrolytes off. The system then analyzes only the blood gas parameters for the
current sample.
By default, the Parameter Selection option is off. When the Parameter Selection
option is off, the system displays the parameter as available but it does not display
the parameter as a button and you cannot select it. This means you cannot turn
parameters off at the Analysis screen.
When you turn on the Parameter Selection option, the names of the parameters
display as buttons on the Analysis screen. You select the parameters to turn them
off or back on before analyzing a patient sample. After analysis, all available
parameters are turned on.
1. At the Setup screen, select Sample > Parameter Selection.
2. At the Parameter Selection at Analysis screen, select Parameter Selection to
turn it on or off and then select Save.

Defining Custom Panels


A custom panel contains a set of parameters that you define to meet your testing
needs. A custom panel allows you to select all the parameters you select for a test
with one touch. You can create up to 6 custom panels on the Rapidlab 1200
system. You can also select a default custom panel.
You can set up 6 custom panels for 6 different panels of tests.
You can select custom panels and a default custom panel for both normal samples
and microsamples.
NOTE: The Analysis screen only displays custom panels after you define panels
in the Parameter Selection screens.
The Analysis screen displays the custom panels in the left lower corner of the
screen. Since the Analysis screen can display only 3 custom panels at a time, the
system divides the panels into 2 sets of 3 each. At the Analysis screen, you can
select and display set 1 or set 2 but not both sets. Consequently, if you define
custom panels that could be used together, ensure you define them within the
same set.
NOTE: If you do not configure any panels for a set, the system does not display
the set selection buttons at the Analysis screen. If you do not select any
parameters for a panel button, the system does not display the panel button at the
Analysis screen

02087462 Rev. V
8-12 Rapidlab 1200 Operator’s Guide: System Configuration

Define a Custom Panel

To define a custom panel, perform the following steps.


NOTE: Custom panels can only be defined for patient samples.
1. At the Setup screen, select Sample > Parameter Selection.
Three columns display. The first column displays a Default button. The second and
third columns each display 3 sets of custom buttons.
2. Select a panel button from the second or third column.
You may select any of the panel buttons in any order.
A screen displays available parameters.
3. Select parameters.
The Microsample button displays at the top-right of the screen.
4. To select a custom panel for microsample analysis, select Microsample.
To select a normal panel, go to 5.
NOTE: If Microsample is selected, parameters not available for microsample analysis
such as tHb and nBili do not display.
5. Select Save.
6. At the Parameter Selection at Analysis screen, verify that the panel button contains all
the parameters you selected.
Microsample panels display a µ character at the top-left of the panel.
Repeat steps 2 through 6 for all panels and sets you want to configure.
7. Select Save.

Select a Default Custom Panel


1. At the Setup screen, select Sample > Parameter Selection.
2. Select the first panel in the first column.
3. Select parameters.
The Microsample button displays at the top-right of the screen.
4. To select a custom panel for microsample analysis, select Microsample.
To select a normal panel, go to 5.
NOTE: If Microsample is selected, parameters not available for microsample analysis
such as tHb and nBili do not display.
5. Select Save.
6. Select Default.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-13

NOTE: Only the first panel in the first set can be selected as a default panel.
7. Select Save > Return > Analysis.
The default panel is selected automatically. Parameters that are not in the
default panel do not display. You can deselect the default panel at the Analysis
screen, then select a different custom panel or select other parameters.
Microsample panels display a µ character at the top-left of the panel.

Setting up Sample Types


You can select the default patient sample type that is selected at the Analysis
screen. The default sample type, which is either arterial syringe or capillary tube,
is displayed with a check mark at the Analysis screen. Operators can select
Continue to begin analysis of the default patient sample type, or they can select
another sample type.
1. At the Setup screen, select Sample > Sample Type.
2. Select the sample type button that you want as the default selection.
3. Select Save.

Setting up Parameters
When you select Parameters at the Setup Window, the following options are
available:
• Parameter On/Off
• Parameter Units
• Demographic Units
• Values

Using the Parameters On/Off Screen


At the Setup screen, select Parameters > Parameters On/Off to select the
parameters you want the system to report. Use the following guidelines when
using the Parameters On/Off screen:
• The system displays certain parameters as gray on the Parameters On/Off
screen and you cannot select them.
These parameters are either not available on the system or other required
parameters were not selected in Setup. For example on Rapidlab1240 and
1260 systems, tHb is not available, and on Rapidlab 1245 and 1265 systems,
if tHb is not selected other parameters that require tHb are not available.

02087462 Rev. V
8-14 Rapidlab 1200 Operator’s Guide: System Configuration

• If you turn a parameter off, leave Setup, and then turn the parameter on again in Setup,
you may need to calibrate and QC the parameter.
The sensor for that parameter is out of calibration until it passes a successful
calibration. The sensor may also have failed QC if Required QC or AutomaticQC was
scheduled while the parameter was turned off.
• When you select a parameter that uses a sample demographic to report results, the
system automatically turns the demographic on.
For a list of parameters that are dependent on sample demographics and other
parameters for results, refer to Required Parameters and Sample Demographics‚
page 8-17.

Specific Parameter Guidelines

Using Hct
• On Rapidlab 1245 and 1265 systems, Hct is a calculated value determined from the
tHb result.
• To report Hct, ensure that tHb is selected at the first Parameters On/Off screen and Hct
is selected at the second screen.

Using O2SAT and O2CT


• You can select both O2SAT(est) and sO2.
If parameters that are required to report sO2 are not available, the system reports
O2SAT(est).
• You can select both O2CT(est) and ctO2.
If parameters that are required to report ctO2 are not available, the system reports
O2CT(est).

Using tHb
• When tHb is on, the CO-ox fractions are also on.
• If tHb is off, the CO-ox fractions are off.
NOTE: CO-ox fractions may be turned off independently, but if tHb is selected again,
the fractions are turned on.
• When tHb is selected at the Sample Demographic screen, tHb is not available on the
Parameters On/Off screen.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-15

Setting Parameters On or Off


1. At the Setup screen, select Parameters > Parameter On/Off.
At the Parameters On/Off screen, selected parameters have a check mark.
2. Select the parameters to turn them on or off.
Use the arrows at the bottom of the screen to scroll through the list of
parameters.
3. Select Save.

Setting up Parameter Units


Use this screen to select the units of measure for parameters:
1. At the Setup screen, select Parameters > Parameter Units.
The screen shows parameters for which you can select alternate units of
measure.
2. Select the parameter you want to change.
3. Select the units that you want to use for that parameter.
4. Select Save.
5. Repeat Steps 2 through 4 to select the units for other parameters.
6. Select Save.
NOTE: If you change units of measure and then print results for samples
saved earlier, the data may display differently on the reports. To see which
parameters have alternate units of measure, refer to Default and Alternate
Units of Measure‚ page 8-16.

Setting up Demographic Units


Use this screen to select the units of measure for sample demographics that have
units, such as temperature and FIO2.
1. At the Setup screen, select Parameters > Demographic Units.
2. Select the demographic you want to change.
3. Select the units that you want to use for that demographic.
4. Select Save.
5. Repeat steps 2 through 4 to select the units for other demographics.
6. Select Save.

02087462 Rev. V
8-16 Rapidlab 1200 Operator’s Guide: System Configuration

Default and Alternate Units of Measure


This table lists the parameters the system can report and the default and alternate units of
measure for each parameter.
Parameter Default Units Alternate Units
pH (pH units) nmol/L
When selecting alternate units, the parameter name
changes to H+.
pCO2 mmHg kPa
pO2 mmHg kPa

Na+* mmol/L

K+* mmol/L

Ca++* mmol/L mg/dL

Cl¯* mmol/L

Glu* mg/dL mmol/L

Lac* mmol/L mg/dL

tHb† g/dL g/L, mmol/L

FO2Hb† % (decimal)

FCOHb† % (decimal)

FMetHb† % (decimal)

FHHb† % (decimal)
pH(T) (pH units) nmol/L
When selecting alternate units, the parameter name
changes to H+(T).
pCO2(T) mmHg kPa
pO2(T) mmHg kPa
HCO3¯act mmol/L
HCO3¯std mmol/L
BE(B) mmol/L
BE(ecf) mmol/L
ctCO2 mmol/L

Ca++ (7.4) mmol/L mg/dL

sO2† % (decimal)

O2SAT(est) % (decimal)
O2CT mL/dL mL/L, mmol/L

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-17

Parameter Default Units Alternate Units


AnGap mmol/L
Hct† % (decimal)
A calculated value determined from the total
hemoglobin value.
BO2† mL/dL mL/L, mmol/L

pO2(A-a)(T) mmHg kPa


pO2(a/A)(T) % (decimal)

p50† mmHg kPa


% (decimal)
sp/ t(T)†
% (decimal)
sp/
t(T)(est)†
RI(T) % (decimal)
pO2/FIO2 mmHg/% kPa/%

ctO2(Hb)† mL/dL mL/L, mmol/L


ctO2(Hb) is reported in place of ctO2(a), ctO2(v),
ctO2( ), if pO2 is not available.

ctO2(a)† mL/dL mL/L, mmol/L

ctO2( )† mL/dL mL/L, mmol/L

ctO2(v)† mL/dL mL/L, mmol/L

ctO2(a- )† mL/dL mL/L, mmol/L

ctO2([a- ]/a)† % (decimal)

O2† mL/min L/min, mmol/min

O2† mL/min L/min, mmol/min

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

Required Parameters and Sample Demographics


The following table lists the parameters and sample demographics you must select
to obtain results for the parameters listed in the table.
Parameter Required Parameters and Sample Demographics
H+(T) H+, temperature
pH(T) pH, temperature
pCO2(T) pCO2, temperature

02087462 Rev. V
8-18 Rapidlab 1200 Operator’s Guide: System Configuration

Parameter Required Parameters and Sample Demographics


pO2(T) pO2, temperature
HCO3¯act pCO2, pH
HCO3¯std tHb*, BE(B), sO2, or O2SAT(est)
BE(B) tHb*, pH, HCO3-act
BE(ecf) pH, HCO3¯act
ctCO2 pCO2, HCO3¯act
Ca++ (7.4) Ca++, pH
sO2 (FHHb and FO2Hb) or (FO2Hb, FCOHb and FMetHb)
O2CT tHb (measured or entered), pO2, O2SAT(est), O2 binding factor†
O2SAT(est) pH, pO2, BE(B)
AnGap Na+, K+, Cl¯, HCO3¯act

Hct‡ tHb
BO2 tHb, (FHHb and FO2Hb) or (FCOHb and FMetHb)
pO2(A-a)(T) pO2(T), FIO2, temperature, pCO2, pAtm
pO2(a/A)(T) pO2(T), FIO2, temperature, pCO2, pAtm
p50 pO2, pH, BE(B), sO2
tHb, ctO2(a), ctO2(a- ), FIO2, temperature, pCO2, pAtm, O2
sp/ t(T)
binding factor‡, (FHHb and FO2Hb) or (FO2Hb, FCOHb, and
FMetHb)

sp/ t(est)(T) tHb, ctO2(a), ctO2(a- )(entered)‡, FIO2, temperature, pCO2,


pAtm, O2 binding factor‡, (FHHb and FO2Hb) or (FO2Hb,
FCOHb, and FMetHb)
RI(T) pO2(T), pO2(A-a)(T)
pO2/FIO2 pO2, FIO2
ctO2(Hb) tHb, FO2Hb, O2 binding factor‡
ctO2(a) tHb, FO2Hb, pO2, O2 binding factor‡
ctO2( ) tHb, FO2Hb, pO2, O2 binding factor‡
ctO2(v) tHb, FO2Hb, pO2, O2 binding factor‡
ctO2(a- ) ctO2(a), ctO2( )
ctO2([a- ]/a) ctO2(a), ctO2(a- )

O2 ctO2(a), t

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-19

Parameter Required Parameters and Sample Demographics

O2 ctO2(a- ), t
* If ctHb is not available as an entered value and tHb is not available, the system uses 15 g/dL as a
default value.
† The system uses a default value for these parameters.
‡ A calculated value determined from the total hemoglobin value.

Setting up Values
Use this screen to enter the default values for the O2 Binding Factor (OBF) and
ctO2(a- ):
1. At the Setup screen, select Parameters > Values.
The screen shows the current values.
2. Select the demographic you want to change.
3. Enter a value and then select Save.
4. Select Save.

Setting up System Options


When you select System Options at the Setup Window, the following options are
available:
• Country Options
• Date and Time
• Sound
• Other

Setting up Country Options


The Country Options screen allows you to perform the following tasks:
• Select a language for the system screens and videos
• Select a date format for your laboratory

02087462 Rev. V
8-20 Rapidlab 1200 Operator’s Guide: System Configuration

Selecting a Language
You can select the language for the text on the system screens and messages and the
language used in the videos. English is the default language. You may access other
languages on the drop-down list.
1. At the Setup screen, select System Options > Country Options.
2. Select the language.
3. Select Save.
The Wait screen displays while the system converts the screens to the new language.
If you select the wrong language, you can return to the language selection screen and
select the correct language.

Selecting the Date Format


You can change the format of the system date.
Format Example
mm/dd/yyyy October 14, 2004 displays as 10/14/2004
This is the default format.
dd.mm.yyyy October 14, 2004 displays as 14.10.2004
yyyy.mm.dd October 14, 2004 displays as 2004.10.14
1. At the Setup screen, select System Options > Country Options.
2. Select the date format that you want and then select Save.

Setting up the Date and Time


NOTE: The system time does not change automatically for Daylight Saving Time. If your
location is affected by a time change, refer to Change System Time for Daylight Saving
Time‚ page 5-63.
You can change the date and time that displays on the banner. The system uses the date
and time to determine the analysis date and time, to determine when Required QC and
AutomaticQC analysis are due, and to determine when cartridge replacement is necessary.
1. At the Setup screen, select System Options > Date and Time.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-21

2. Change the date and time.


If you want to... Then...
change the date, a. Select Date.
b. Enter the date in the format shown on the screen.
Enter a leading zero before numbers less than 10. For
example, if the date format is mm/dd/yyyy, enter
February 4, 2007 as 02042007.
change the time, a. Select Time.
b. Enter the time in 24-hour format.
Enter a leading zero before numbers less than 10. For
example, enter 10:07 PM as 2207.
3. Select Save.

Setting up the Sound


You can adjust the volume for system sounds and videos, and turn off the sound
that occurs when you select buttons.
NOTE: Other sounds, such as beeps that alert you to system events that require
your attention, are always on.
1. At the Setup screen, select System Options > Sound.
2. Adjust the volume or turn the sound off.
If you want to... Then...
adjust the volume for the system a. Select a number for the system volume level.
sound, b. Select Preview to hear the volume at that level.
adjust the volume for the video a. Select a number for the video volume level.
sound, b. Select Preview to hear the volume at that level.
turn off the sound that occurs select Touch Sound.
when you touch buttons,
3. Select Save.

Setting up Other Options


Use this procedure to enter a name that identifies the system and the phone
number for technical support. The system displays the name and phone number on
the System Information screen, but the system prints only the system name on
printed reports.
1. At the Setup screen, select System Options > Other Options.
2. Enter the telephone number.
3. Select System Name and then enter a name for the system.
4. Select Save.

02087462 Rev. V
8-22 Rapidlab 1200 Operator’s Guide: System Configuration

Setting up Printer and Devices Options


When you select Printer and Devices at the Setup Window, the following options are
available:
• Printer Options
• Barcode Setup
• Communications

Selecting Printer Options


The Setup–Printer Options screens allow you to perform the following functions:
• enable or disable the internal and external printer
• select the number of copies for patient and QC sample reports
• select printer settings for each type of reports
The Setup–Printer Options screen displays options based on the selected report. Select
several different reports to view the available options.
To set up printer options, perform the following steps:
1. At the Setup screen, select Printer and Devices > Printer Options.
2. At the Printer Options screen, select the report type from the scrollable list.
The system displays only those options that are available for that report.
3. Select the printer that you want to print this report, Internal Printer or External
Printer.
To print this report on both printers, complete these steps for one printer then select
the other printer.
4. Select Use.
5. Select Auto Print, if it is available.
When you select Auto Print, the system automatically generates the report when it
completes the analysis.
6. Select the number of copies to print: 1, 2, or 3.
The default number of copies is 1. If this selection is not available, the system prints
only one copy.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-23

7. If you select a Calibration Report, select either Status or Full.


Refer to Generating Calibration Reports‚ page 3-3.
8. If you are selecting a Sample or QC report, select Ranges to include ranges
on the report.
The default for including ranges is off.
9. If you want to print the report to the other printer, select it and make the
selections you want for the report on that printer.
10. Select another report, as needed.
When you select another report, the system displays the options for that
report. You must repeat the above procedure to set up printing for each report
that you want to print.
11. When you are done selecting reports, select Save.

Setting up Barcode Options


Use this screen to turn the barcode scanner on or off, and to specify the symbology
and format for patient ID, accession number, and password barcodes.
This screen can also be used to select the barcode only option for Patient ID data
entry. Refer to Selecting the Barcode Only Option for Patient ID Entry‚
page 8-25.
• The patient ID can be up to 20 alphanumeric characters in length. The
accession number and password barcodes can be up to 13 alphanumeric
characters in length.
• Within each barcode, you can turn any characters off that you do not want the
system to include as part of the patient ID or the accession number.
• The system automatically turns off any non alphanumeric characters, such as
hyphens, that are displayed in the barcode.
• You can specify 1 or 2 fixed lengths for Interleaved 2 of 5 barcodes.
NOTE: If the barcode scanner was not connected during installation of the
system, connect the barcode scanner to the system. Refer to Connecting the
Barcode Scanner‚ page 8-26, before completing this procedure.
1. At the Setup screen, select Printer and Devices > Bar Code Setup.
NOTE: If you have selected the Required QC analysis option, you must leave
the barcode scanner on.
2. You can select barcode to turn the barcode scanner on or off.

02087462 Rev. V
8-24 Rapidlab 1200 Operator’s Guide: System Configuration

3. Select the barcode symbology that your institution uses.


• 128, the default
• Code 39
• Code 39 with check digit
• Codabar
• Interleaved 2 of 5 (I/2 of 5)
• Interleaved 2 of 5 (I/2 of 5) with check digit
4. If the symbology is Interleaved 2 of 5, enter the number of characters:
a. Select I/2 of 5 Length.
b. Enter the physical number of characters, including check digit if present.
The physical length of the barcode may be up to 32 characters. The system can
read the first 20 characters and accepts up to 20 characters for the patient ID, and
up to 13 of these 20 characters for the accession number.
c. Enter 0 in a field or enter the same value in both fields if all barcodes are the same
length.
d. Select Save.
5. Define the characters for the patient ID, accession number, or password barcodes:
a. Select the appropriate barcode button.
If you want to set up... Select...
patient ID barcodes, Patient ID barcode.
accession number barcodes, Accession No. barcode.
password barcodes, Password barcode.

b. Scan the appropriate barcode.


The barcode you scan can be up to 20 characters in length. The system can accept
up to 20 characters for the patient ID, but accepts a maximum of 13 characters for
the accession number and password. If your barcode for these settings is longer
than 13 characters, you must indicate the characters the system can ignore.
c. Select any characters you want to exclude from the barcode.
For example, if the barcode you scanned is 12345 and you turn positions 1 and 2
off, the system ignores characters in those positions. The patient ID from the
barcode is then 345.
d. Select Save.
e. Repeat Steps a through d for each type of barcode.
6. At the Bar Code Setup screen, select Save.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-25

Selecting the Barcode Only Option for Patient ID Entry


Restricting patient ID entry to barcode only entry minimizes errors that can occur
when the patient ID is entered manually.
NOTE: When the barcode only patient ID data entry option is active, the patient
ID becomes a required Demographic field and data entry using the numeric
keypad or alphanumeric keyboard is disallowed.
1. At the Setup screen, select Printer and Devices > Bar Code Setup.
2. Select Patient ID Bar Code.
3. Select Input Via Barcode Only.
4. Select Save.

Setting up the Barcode Scanner


1. At the Setup screen, select Printer and Devices > Bar Code Setup.
2. You can select barcode to turn the barcode scanner on or off.
3. Select the barcode symbology that your institution uses for the patient ID,
accession number, and password barcodes.
For information about setting up the barcode symbology, refer to Setting up
Barcode Options‚ page 8-23.
For information about connecting the barcode scanner, refer to Connecting the
Barcode Scanner‚ page 8-26.

LASER WARNING: Never look directly at the beam of a hand-held barcode


scanner or point the scanner at another person. Also, do not look at the
reflection of the beam from a shiny surface. For more information about laser
safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers.
4. Test the scanner:
a. Aim the scanner away from you.
b. Press the trigger.
The red laser beam lights when the barcode scanner is on.

02087462 Rev. V
8-26 Rapidlab 1200 Operator’s Guide: System Configuration

Connecting the Barcode Scanner


You need the a barcode scanner kit, including the barcode scanner, cable, and holder for
this activity.
NOTE: Use only the barcode scanner kit provided by the manufacturer. For the part
number of the barcode scanner kit, refer to Supplies‚ page D-1.

WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.

Attaching the Barcode Scanner


1. Remove power from the system:
a. Select Status > Shutdown.

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.

b. At the Shutdown screen, turn the power switch off.


2. Connect the barcode cable to the barcode scanner connector.
The barcode scanner connector is located on the back panel of the system and is
labeled with a barcode symbol.
3. Tighten the hold-down screws on the connector.
4. Attach the holder for the barcode scanner to the left side of the system.
5. Turn the on power switch.

Setting up Communications
Use the Communications screen to setup a time for sending system data, and setup
connections to external devices. For systems connected to an LIS, this screen can also be
used to select cSO2

Defining Send System Data Option


Use this procedure to define the time to automatically send system data to the e-mail
address defined by your local technical service provider.
1. At the Setup screen, select Printer and Devices > Communications.
2. Select Send System Data.
3. Enter the time to send the data.
4. Select Save.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-27

Connecting to a Rapidlink® or Rapidcomm® System


You can connect the Rapidlab 1200 systems to a Rapidlink or Rapidcomm data
management system using either of the following methods:
• Serial (RS-232) connection
• Ethernet network that uses a 10Base-T connection
Both methods allow you to connect the Rapidlab 1200 systems to a single
Rapidlink or Rapidcomm server, or to a Rapidlink or Rapidcomm workstation.
NOTE: External devices connected to the digital interfaces must be certified to
IEC standards, for example IEC 950 for data processing equipment and IEC
60601-1 for medical equipment. All configurations should comply with system
standard IEC 60601-1. When you connect additional equipment to the signal input
or output port, the system must comply with the requirements of IEC 60601-1.
Consult your local technical support provider or distributor if necessary.

Setting up a Serial (RS-232) Connection

You need the following materials for this activity:


• Rapidlab 1200 system to Rapidlink or Rapidcomm interface cable
• Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide

WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.

1. Select Status > Shutdown.


2. When the Shutdown screen is displayed, turn the power off.

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.

3. Connect the interface cable to the system and to the Rapidlink or Rapidcomm
server or workstation:
a. Connect the 9-pin connector on the cable to the serial (RS-232) port
located on the back panel of the Rapidlab 1200 system.
b. Connect the other connector on the cable to a serial port on the Rapidlink
or Rapidcomm server or workstation.
4. Turn the power on.
5. Select the communication settings at the Rapidlab 1200 system:
a. Select Status > Setup.
b. If required, enter your password.

02087462 Rev. V
8-28 Rapidlab 1200 Operator’s Guide: System Configuration

c. Select Printer and Devices > Communications.


d. Select RS-232 > Configure.
e. Select the following options for the communication settings:
Setting Default Selection
Baud 9600
Parity Even
Data Bits 8
f. Select Save.
6. At the Communications screen, select Save.
7. When prompted that the connection was unsuccessful, select Continue.
8. At the Rapidlink or Rapidcomm server or workstation, enter the communication
settings given above.
Refer to the Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide.
9. At the Rapidlab 1200 system, select Save.
10. Select Return.
11. To complete any additional setup that may be necessary to operate the Rapidlab 1200
system with the Rapidlink or Rapidcomm program, refer to the Rapidlink Supervisor’s
Manual or Rapidcomm User’s Guide.

Connecting to a CompleNet® Network Connection


CompleNet network connection is a proprietary protocol that allows real-time
communication between a Rapidlab 1200 system and a Rapidlink or Rapidcomm
workstation. Use this protocol to connect your system to a Rapidlink or Rapidcomm
workstation if your Rapidlink or Rapidcomm system is part of an Ethernet network that
uses a 10Base-T connection.
You need the following materials for this activity:
• Twisted-pair cable with RJ-45 connector
• Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide
Select 1 of the following methods to configure the network connection:
• Enter IP addresses
• Use DHCP (dynamic host configuration protocol)

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-29

Entering IP Addresses
Use this procedure to enter network IP addresses.
1. Obtain the following network information from your institution’s network
administrator:
• IP address for the Rapidlab 1200 system
• IP address for the Rapidlink or Rapidcomm server or workstation where
you want to connect the Rapidlab 1200 system
• IP address for the default router port assigned to the network segment on
which the Rapidlab 1200 system is located
• Network mask for the institution’s network
2. Select the communication settings at the Rapidlab 1200 system:
a. At the Setup screen, select Printer and Devices > Communications.
b. Select CompleNet > Configure.
c. Select Save.
d. Select Enter IP Address.
e. Enter the IP addresses for the Rapidlab 1200 system, the default router
port, and the network mask.
Ensure that you enter the IP addresses and the network mask in the correct
fields.
f. Select Save.
3. At the Communications screen, select Save.
4. When prompted that the connection was unsuccessful, select Continue.
5. Connect the network cable to the RJ-45 connector on the back panel of the
Rapidlab 1200 system.
6. Connect the network cable to the site network connection.
7. At the Rapidlink or Rapidcomm workstation, enter the communication
settings.
Refer to the Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide.
8. At the Rapidlab 1200 system, select Save.
9. Select Return when finished.
10. To complete any additional setup that may be necessary to operate the
Rapidlab 1200 system with the Rapidlink or Rapidcomm program, refer to the
Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide.

02087462 Rev. V
8-30 Rapidlab 1200 Operator’s Guide: System Configuration

Using DHCP
Use this procedure to use dynamic host configuration protocol.
1. Select the communication settings at the Rapidlab 1200 system:
a. At the Setup screen, select Printer and Devices > Communications.
b. Select CompleNet > Configure.
c. If you want to change the name for the Rapidlab 1200 system, select
Rapidlab 1200 and enter the name for the Rapidlab 1200 system.
d. Select Continue.
e. Select Use DHCP > Save.
f. At the Communications screen, select Save.
2. When prompted that the connection was unsuccessful, select Continue.
3. Connect the network cable to the RJ-45 connector on the back panel of the
Rapidlab 1200 system.
4. At the Rapidlink or Rapidcomm workstation, enter the communication settings.
Refer to the Rapidlink Supervisor’s Manual or Rapidcomm User’s Guide.
5. At the Rapidlab 1200 system, select Save.
6. Select Return.
7. To complete any additional setup that may be necessary to operate the Rapidlab 1200
system with the Rapidlink or Rapidcomm program, refer to the Rapidlink Supervisor’s
Manual or Rapidcomm User’s Guide.

Selecting sO2 as a Measured or Calculated Value for LIS


Transmission (LIS only)
You can report sO2 values to the LIS as a measured or calculated value. The cSO2 and
msO2 buttons are grayed out if the system is not connected to an LIS.
1. At the Setup screen, select Printer and Devices > Communications.
2. Select cSO2 or msO2.
3. Select Save.

Connecting to a Laboratory Information System


Use this procedure to connect the Rapidlab 1200 system to a hospital or laboratory
information system (LIS) using a serial (RS-232) connection. Refer to the Rapidlab 1200
Interface Specification Manual to configure a hospital or laboratory information system
for the Rapidlab 1200 system.
You need an interface cable for this activity.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-31

NOTE: External devices connected to the digital interfaces must be certified to


IEC standards (i.e. IEC 950 for data processing equipment and IEC 60601-1 for
medical equipment). All configurations should comply with system standard IEC
60601-1. When you connect additional equipment to the signal input or output
port, the system must comply with the requirements of IEC 60601-1. Consult your
local technical support provider or distributor if necessary.

WARNING: Do not proceed while the power is on. To prevent electrical shock or
damage to the system, remove power from the system as described in this
procedure.

1. Select Status > Shutdown.

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.

2. At the Shutdown screen, turn the power switch off.


3. Connect the interface cable to the Rapidlab 1200 system and to the LIS:
a. Connect the 9-pin connector on the cable to the serial (RS-232) port on
the back panel of the Rapidlab 1200 system.
b. Connect the other connector on the cable to the LIS.
4. Turn the power switch on.
5. Select the communication settings at the Rapidlab 1200 system:
a. Select Status > Setup.
b. If required, enter your password.
c. Select Printer and Devices > Communications.
d. Select RS-232 > Configure.
e. Select the communication settings that the LIS requires:
Setting Default Options
Baud 9600 1200, 2400, 4800, 9600, 19200
Parity Even None, Odd, Even
Data Bits 8 7, 8

f. Select Save.
6. At the Communications screen, select Save.
If an error message displays, refer to Viewing System Messages‚ page 6-74.
7. Select Return.
8. Complete any setup at the LIS that may be required to communicate with the
Rapidlab 1200 system.

02087462 Rev. V
8-32 Rapidlab 1200 Operator’s Guide: System Configuration

Setting up Auto Send Options


You can select the type of results to automatically send to a connected LIS, Rapidlink, or
Rapidcomm data management system at the end of analysis.
• Patient results
• Calibration and QC results
Both types of results have a default value of On. Results are also sent when you select the
Print or the Send button.
1. At the Setup screen, select Printer and Devices > Communications.
NOTE: You must select either RS-232 or CompleNet to make the Auto Send options
available.
2. Select Patients or Calibrations and QC to turn the option on or off.
3. Select Save.

Setting Up Remote Viewing (Rapidcomm Only)


NOTE: Remote viewing and control require the cooperation of the Rapidcomm
administrator and operators at local systems. We recommend you establish a policy for the
remote viewing and control feature.
The display at local systems can be viewed and controlled remotely using the Rapidcomm
software. The Rapidcomm software enables the user at an LIS to monitor and troubleshoot
the local system remotely.
• Before a remote user can view and control the local system, the local system operator
must enable the remote viewing feature and allow a remote user to connect to the local
system. This ensures that no conflict occurs between local and remote users who want
to view and control the system at the same time.
• If a local system operator allows a remote viewer to view the local system, the remote
user can either view and take control of the local system or allow the operator to retain
control while the remote user only views the system display.

Enabling Remote Viewing


1. At the Setup screen, select Printer and Devices.
Select the down arrow and then select Remote Viewer.
At the Remote Viewer screen a Services column and a Configure column display.
2. To enable remote viewing, select Start in the Service column.
To disable remote viewing, select Stop in the Service column.
Stop is the default setting.
3. Select Continue.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-33

Enabling Remote Viewing Automatically or Manually

Automatic remote viewing allows the remote user to connect to the local system
any time the local system is operational. Remote viewing is available to remote
users when the local system is restarted.
Manual remote viewing requires the local operator to decide when to allow
remote viewing. Remote viewing is unavailable to remote users when the local
system is restarted.
1. At the Setup screen, select Printer and Devices.
Select the down arrow and then select Remote Viewer.
At the Remote Viewer screen a Services column and a Configure column
display.
2. To enable remote viewing automatically, select Automatic in the Configure
column.
To disable remote viewing, select Manual in the Configure column.
Manual is the default setting.
3. Select Continue.

02087462 Rev. V
8-34 Rapidlab 1200 Operator’s Guide: System Configuration

Enabling Remote Viewing Using the Remote Viewing Buttons in the Banner
1. Enable remote viewing by following the procedure in Enabling Remote Viewing‚
page 8-32.
The message Disconnect Remote User displays when remote viewing is enabled and a
remote user connects to the local system. The message displays in the top-left corner
of the banner and alternates, at 5second intervals, with the current system status text.
When Disconnect Remote User displays, a remote viewer is connected to the system
and can view and control the system.
The Disconnect Remote User button also functions as a touch screen button.
2. To disconnect the remote viewer, select Disconnect Remote User.
The Disconnect Remote User message changes into Enable Remote Viewer message.
When the Enable Remote Viewer message displays, the remote user is disconnected
and cannot view or control the local system.
The Enable Remote Viewer message also functions as a touch screen button.
3. To enable remote viewing, select Enable Remote Viewer.
When selected, the Enable Remote Viewer button ceases to display.
When a remote user connects to the local system after the Enable Remote Viewer
button is selected, the Disconnect Remote Viewer button displays.
As explained in step 2, selecting the Disconnect Remote Viewer button disconnects
the remote user and the Enable Remote Viewer button displays, and can be used to
enable a remote viewer.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-35

Setting up Secured Options


The secured options screen allows you to determine the level of access to the
system and set up the level of access for individual operators.
The security access for the system and the level of access assigned to individual
operators together determine which functions an operator can access and which
functions an operator can access only with a password. When you select
Restricted access, the system displays the Sign In screen instead of the Analysis
screen when the system is idle. Operators must enter a password to display the
Analysis screen. If an operator is given a level that cannot access a function, a
message appears indicating that the operator cannot access the feature.

Setting up System Access


You can select the security access you want for the system:
• Restricted access
Operators must enter a password to use the system.
• Limited access
Operators can perform routine tasks, such as analyzing samples, without
entering a password.
• Unrestricted access
Operators can perform routine tasks without entering a password and
Operators can access the Setup options.
Use this screen to select the level of system access:
1. At the Setup window, select Secured Options > System Access.
2. Select the level of system access: Restricted, Limited, or Unrestricted.
3. Select Save.

Setting up Operator Security Levels


The security access for the system and the level of access assigned to individual
operators together determine which functions an operator can access and which
functions an operator can access only with a password.
The following table contains the level and password status for each function. To
set up Operator IDs and Security Levels, refer to Defining Operator IDs and
Passwords‚ page 8-37.

02087462 Rev. V
8-36 Rapidlab 1200 Operator’s Guide: System Configuration

When access is Restricted, the system requires a password for every level of operator for
all functions.
Table 8-1 Restricted Access Setting
Level/Pass Level/Pass Level/Pass Level/Pass
Function 1 2 3 4
analyzing samples Yes/Yes Yes/Yes Yes/Yes Yes/Yes
recalling data Yes/Yes Yes/Yes Yes/Yes Yes/Yes
replacing cartridges Yes/Yes Yes/Yes Yes/Yes No
initiating calibrations Yes/Yes Yes/Yes Yes/Yes No
accessing Setup Yes/Yes Yes/Yes No No
options
accessing Diagnostics Yes/Yes Yes/Yes No No
accessing the Restore Yes/Yes Yes/Yes Yes/Yes No
QC screen
accessing secured Yes/Yes No No No
options

When access is Limited, some functions do not require a password.


Table 8-2 Limited Access Setting
Level/Pass Level/Pass Level/Pass Level/Pass
Function 1 2 3 4
analyzing samples Yes/No Yes/No Yes/No Yes/No
recalling data Yes/No Yes/No Yes/No Yes/No
replacing cartridges Yes/Yes Yes/Yes Yes/Yes No
initiating calibrations Yes/Yes Yes/Yes Yes/Yes No
accessing Setup Yes/Yes Yes/Yes No No
options
accessing Diagnostics Yes/Yes Yes/Yes No No
accessing the Restore Yes/Yes Yes/Yes Yes/Yes No
QC screen
accessing secured Yes/Yes No No No
options

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-37

The Unrestricted access setting allows for more access with fewer password
requirements on every level.
Table 8-3 Unrestricted Access Setting
Level/Pass Level/Pass Level/Pass Level/Pass
Function 1 2 3 4
analyzing samples Yes/No Yes/No Yes/No Yes/No
recalling data Yes/No Yes/No Yes/No Yes/No
replacing cartridges Yes/No Yes/No Yes/No Yes/No
initiating calibrations Yes/No Yes/No Yes/Yes Yes/Yes
accessing Setup Yes/No Yes/No Yes/No Yes/No
options
accessing Diagnostics Yes/Yes Yes/Yes No No
accessing the Restore Yes/Yes Yes/Yes Yes/Yes No
QC screen
accessing secured Yes/Yes No No No
options

Defining Operator IDs and Passwords


You can enter, edit, or delete operator IDs and passwords and specify the level of
access for each operator. Refer to the tables in Setting up Operator Security
Levels‚ page 8-35.
If your Rapidlab 1200 system is connected to a data management system, you can
turn on the option to notify operators when their password is about to expire. The
message is displayed 14 days before the password expires.
The default operator ID and password is 12345, with Level 1 access. Define at
least 1 operator with Level 1 access and then delete the default operator ID. You
can enter information for up to 5000 operators. Ensure at least one Level 1
operator is entered in the operator list when you download operators to the system
NOTE: Instrument screen transition time into and out of instrument Setup may be
slow while the analyzer is processing the new list, if the operator list downloaded
to the system is large or a large preexisting operator list is modified in instrument
setup.
1. At the Setup screen, select Secured Options > Operator Security.
Each operator ID and password combination must be unique.

02087462 Rev. V
8-38 Rapidlab 1200 Operator’s Guide: System Configuration

2. Complete the appropriate tasks:


If you want to... Then...
add an operator, a. Select Add.
b. Enter the operator ID.
c. Select Password and enter the password for the
operator.
d. To enter an alphanumeric operator ID or password,
select the label for the entry field to access the keyboard
screen.
e. Enter the alphanumeric value and then select Save.
f. Select the security level for the operator and then select
Save.
edit information for an a. Select the operator.
operator, b. Select Edit.
c. Edit the operator ID, password, or security level.
delete an operator, a. Select the operator.
b. Select Delete.
notify operators of select Expiration Pending.
expiring password,
3. Select Save.

Setting Up Analysis Options


The Analysis Options screen allows you to make changes to the demographic information,
to display question results, to enable microsample flagging, and to define Analytical
Ranges.

Selecting the Save Demographics Option


The save demographics option allows you to re-enter the demographic information from
the previous sample when analyzing a sample from the same patient. Use this option if
you routinely analyze many consecutive samples for the same patient.
1. At the Setup screen, select Secured Options > Analysis Options.
2. Select Save Demographics.
3. Select Save.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-39

Selecting Demographics Editing


The edit demographics option allows you to edit patient and sample demographics
for patient samples that are already saved. When you use this option, you can edit
demographics for individual patient samples when you recall the sample results.
If you edit a patient’s demographics and then print the patient sample report, a
message on the report indicates that the data was edited. If your system is
connected to a Rapidlink or Rapidcomm data management system, or an LIS, the
Rapidlab 1200 system also sends the edited sample data to the computer system.
1. At the Setup screen, select Secured Options > Analysis Options.
2. Select Edit Demographics and then select Save.

Displaying Question Result


Use this option to show results that are flagged as question results. Calibration
verification material sometimes produces results that are displayed as question
results (-----?).
When you turn on this option, the system shows these results, for tHb and the
fractions, with a question mark (?) instead of displaying no results (-----?).

CAUTION: Do not perform analysis during proficiency testing. When this option
is turned on, results for patient samples are not reliable. Turn the option off when
testing is completed.

Use the Display Question Results option with Rapidlab 1245 and 1265 systems to
display the results for tHb and fractions when performing proficiency testing.
To set up Display Question Result, perform the following steps:
1. At the Setup screen, select Secured Options > Analysis Options.
2. Select Display Question Result and then select Save.
3. Select Return.
4. Perform proficiency testing.
5. After proficiency testing, repeat Steps 1 and 2 to turn the Display Question
Results option off.

02087462 Rev. V
8-40 Rapidlab 1200 Operator’s Guide: System Configuration

Flagging Microsample Results


Some samples start as normal samples but the system analyzes them as microsamples
because the system detects insufficient sample material or bubbles in the sample. Selecting
Flag Microsamples allows the system to identify samples as microsamples and to flag
these results.
1. On the Setup screen, select Secured Options > Analysis Options.
2. Select Flag Microsamples.
3. If you want to flag these results as questionable, select Display Question Result.
4. Select Save.

Defining Analytical Range Limits


Analytical Range limits enable you to enter high and low range limits for parameters so
you can qualify the patient reportable range. To derive parameter range limit values, you
must first run Calibration Verification Material (CVM), following the procedure that is
described in the insert for the CVM (Cat: 116189). When enabled, the default values are
the high and low instrument ranges for the selected parameter.
Enable Analytical Range functionality by following these steps:
1. At the Setup screen, select Secured Options.
2. Select Analysis Options > Analytical Ranges.
Define Analytical Range limits for each parameter by following these steps:
1. At the Setup screen, select Sample > Analytical Ranges.
At the Analytical Ranges screen a list of parameters displays. The default low and
high instrument range values for each parameter display.
2. Select a parameter in the List box (use the arrow key to scroll down, if needed).
3. Enter limit values for the parameter in the Low and High limit boxes.
Repeat steps 2–3, as needed, for each additional parameter.
NOTE: Analytical Range limits are not supported for CO-ox fractions.
4. Select Continue.
At the Setup screen, results out of Analytical Range limits are flagged with a red < or
> sign.
To view Analytical Range results, select Patients at the Recall screen.
At the Recall screen, any result exceeding Analytical Range limits displays a red < or >
sign, but a limit value does not display next to the < or > sign.
Printed results display a red < or > sign next to the limit value.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-41

Setting up Calibrations
The Calibrations screen allows you to select the interval when you want a 1-point
calibration run and if you want the system to issue a warning for the pending
calibration.

Setting up the Calibration Interval


You can select a maximum 1-point calibration interval of either 30 or 60 minutes.
The size of the calibration drift may cause a calibration interval that is less than
the chosen maximum.
NOTE: Ensure that your procedures adhere to federal, state, and local regulatory
agency requirements for performing calibrations.
1. At the Setup screen, select Secured Options > Calibrations.
2. Select 60 minute or 30 minute to set the calibration interval.
3. Select Save.

Selecting the Calibration Pending Message


You can turn the Cal Pending message on or off. The Cal Pending message
displays 2 minutes before a scheduled calibration.
1. At the Setup screen, select Secured Options > Calibrations.
2. Select Cal Pending to turn the message on or off.
3. Select Save.

Saving and Restoring System Setup Data


Saving the data to a diskette or CD allows you to create a record of the Setup
options for your system. Use this diskette or CD later to restore the setup options.
If are defining setup options for more than 1 Rapidlab 1200 system with the same
model number, you can use the diskette or CD from the first system to copy the
setup options to your other systems using the Restore option. You can only restore
data to systems with the same model number.
This procedure does not save total cycles, serial number, model number, sample
totals, or any QC, patient, calibration, and cartridge information. The procedure
does save the Rapidlab 1200 system name and IP address defined for a network
connection to a data management system or an LIS. When you restore setup data,
the system copies the name and IP address to the original system but not to other
systems.

02087462 Rev. V
8-42 Rapidlab 1200 Operator’s Guide: System Configuration

You need a formatted 1.44 MB 3.5-inch diskette or 1 CD to complete this activity.


1. At the Setup screen, select Secured Options.
If you want to... select...
save Setup data, Save Setup.
restore Setup data or copy Setup data from another system, Restore Setup.

2. Select the appropriate drive (disk or CD).


3. When prompted, insert a disk or CD into the appropriate drive and select Continue.
4. When prompted, remove the diskette or CD from the drive and select Continue.
5. Store the diskette or CD in a safe place, away from heat and strong magnetic sources
such as centrifuges.

Installing New System Software


You can install new system software from a CD-ROM, disks, or from a network
connection. To install software from a network connection, your system must be
configured for a network and be connected to a device that provides access to the new
system software.
You need the following materials to perform this task:
• Disks containing the Rapidlab 1200 system software
• CD-ROM containing the Rapidlab 1200 system software
You can copy patient, QC, and calibration data to a disk or CD. Refer to Copying Data
Files‚ page 7-2.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-43

1. At the Setup screen, select Secured Options > Software Installation.


2. Install the software:
NOTE: Select Return at any time to exit from the installation without
installing the new software.
If you are
installing from... Then...
CD-ROM, a. Select CD-ROM.
b. When prompted, install the CD.
c. Wait a few seconds until the system reads the data on the
CD.
d. Select Continue.
The system displays the current version number and the new
version number of the software.
e. Select Continue to begin the installation.
f. When prompted, remove the CD from the drive and select
Continue.
Disks, a. Select Disk.
b. When prompted, insert the first disk into the disk drive and
select Continue.
The system displays the current version number and the new
version number of the software.
c. Select Continue to begin the installation.
d. When prompted, remove the disk from the drive, insert the
next disk in the sequence, and then select Continue.
e. Continue removing and inserting disks as prompted.
f. When prompted, remove the last disk from the drive and
select Continue.
Network a. Select Network.
connection, Depending on the type of network configuration, enter either
the name or IP address of the computer that contains the new
system software.
Select Save.
The system displays the current version number and the new
version number of the software.
b. Select Continue to begin the installation.
The system shuts down and restarts to install the new software, moving the
database, as necessary. The system shuts down again and restarts using the
newly installed version of the software.
Depending on the size of your database, this installation can take some time.
A message displays indicating the installation was successful. The system
restarts, which takes several minutes.
3. Store the disks or CDs in a safe place, away from heat and strong magnetic
sources such as centrifuges.

02087462 Rev. V
8-44 Rapidlab 1200 Operator’s Guide: System Configuration

Setting up Correlation Coefficients

CAUTION: Do not change the correlation coefficients until you collect the
appropriate data. Changing correlation coefficients affects the reported results for
patient samples. Before changing correlation coefficients, determine the slope and
offset values, as described in Performing a Correlation Study‚ page 2-34.

Use this procedure to enter slope and offset (intercept) values to correlate the patient
sample results from the Rapidlab 1200 system to those obtained using another
measurement system. The following table lists the valid ranges for slope and offset:
Default Slope Default Offset
Parameter Slope Range Offset Range
pH 1.0 0.8–1.2 0.0 +/- 9.9
pCO2, pO2, Na+, K+, Ca++, Cl¯, Glu, 1.0 0.8–1.2 0.0 +/- 99
Lac, tHb

1. Select Status > Setup > Secured Options.


2. Select the down arrow button and then select Correlation Coefficients.
3. Enter the slope and offset values for each parameter that you want to correlate to
another measurement system.
4. Select Save.

Setting up Maintenance Functions


The following functions are available on the Secured Options > Maintenance screens:
• Setup Schedule
• Export Schedule
• Import Schedule

Setting up a Maintenance Schedule


At the Maintenance–Schedule screen, you can perform the following tasks:
• view maintenance task details
• add up to ten user-defined maintenance tasks
• edit predefined and user-defined maintenance tasks
• delete user-defined maintenance tasks
• enable or disable some predefined and user-defined maintenance tasks

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: System Configuration 8-45

To set up maintenance tasks on your system, perform the following steps:


1. At the Setup screen, select Secured Options.
2. Select the down arrow button and then select Maintenance.
3. Select Setup Schedule.
4. At the Setup Maintenance screen, select and perform the following tasks as
necessary:
For this task... Then...
Add a maintenance task, a. Select Add.
b. Enter a Description.
c. Edit the Frequency.
d. Edit the Task Due On.
e. Select Save.
Edit the frequency of a a. Select a task.
predefined or user b. Select Edit.
defined maintenance NOTE: You cannot decrease the frequency of a predefined
task, task. You can only increase it. You cannot edit the name of a
predefined task.
c. Select Frequency.
d. Select the frequency.
The system displays screens for selecting a time period
or set of times appropriate to your selection.
e. Select Save.
The Save button is not available until you make all the
necessary selections.
Delete a user defined a. Select a task.
maintenance task, b. Select Delete.
NOTE: User defined maintenance tasks are the only tasks
you may delete. When you select a predefined maintenance
task, the Delete button is disabled.
c. Select Yes.
Enable and disable a. Select a task.
maintenance tasks, b. Select Edit.
c. Select Enable.
View maintenance task select Details.
details,

02087462 Rev. V
8-46 Rapidlab 1200 Operator’s Guide: System Configuration

Importing and Exporting Maintenance Activities


1. At the Setup screen, select Secured Options.
2. Select the down arrow button and then select Maintenance.
If you want to... Then...
Import maintenance a. Select Import Schedule.
Data from a disk or CD b. Insert a disk or CD in to the drive.
c. Select Disk or CD.
Schedule information is copied from the disk or CD.
d. When prompted, remove the disk or CD from the drive.
Export maintenance a. Select Export Schedule
Data to a disk or CD b. Insert a disk or CD in to the drive.
c. Select Disk or CD.
Schedule information is copied to the disk or CD.
d. When prompted, remove the disk or CD from the drive.

02087462 Rev. V
Appendix A: Safety Instructions

This information summarizes the established guidelines for handling biohazards.


This summary is based on the guidelines developed by the Centers for Disease
Control, the Clinical and Laboratory Standards Institute Document M29-A3,
Protection of Laboratory Workers from Occupationally Acquired Infections, and
the Occupational Safety and Health Administration’s Bloodborne Pathogens
Standard.1–3

Protecting Yourself from Biohazards


Use this summary for general information only. It is not intended to replace or
supplement your laboratory or hospital biohazard control procedures.
By definition, a biohazardous condition is a situation involving infectious agents
biological in nature, such as the hepatitis B virus, the human immunodeficiency
virus, and the tuberculosis bacterium. These infectious agents may be present in
human blood and blood products and in other body fluids.
The following are the major sources of contamination when handling potentially
infectious agents:
• needlesticks
• hand-to-mouth contact
• hand-to-eye contact
• direct contact with superficial cuts, open wounds, and other skin conditions
that may permit absorption into subcutaneous skin layers
• splashes or aerosol contact with skin and eyes

02087462 Rev. V
A-2 Rapidlab 1200 Operator’s Guide: Safety Instructions

To prevent accidental contamination in a clinical laboratory, strictly adhere to the


following procedures:
• Wear gloves while servicing parts of the instrument that have contact with body fluids
such as serum, plasma, urine, or whole blood.
• Wash your hands before going from a contaminated area to a noncontaminated area,
or when you remove or change gloves.
• Perform procedures carefully to minimize aerosol formation.
• Wear facial protection when splatter or aerosol formation are possible.
• Wear personal protective equipment such as safety glasses, gloves, lab coats or aprons
when working with possible biohazard contaminants.
• Keep your hands away from your face.
• Cover all superficial cuts and wounds before starting any work.
• Dispose of contaminated materials according to your laboratory’s biohazard control
procedures.
• Keep your work area disinfected.
• Disinfect tools and other items that have been near any part of the instrument sample
path or waste area with 10% v/v bleach.
• Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the laboratory.
• Do not mouth pipet any liquid, including water.
• Do not place tools or any other items in your mouth.
• Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or
washing hands.
To prevent needlestick injuries, needles should not be recapped, purposely bent, cut,
broken, removed from disposable syringes, or otherwise manipulated by hand.

References
1. Centers for Disease Control. 1988. Update: Universal precautions for prevention of
transmission of human immunodeficiency virus, hepatitis B virus and other blood
borne pathogens in healthcare settings. MMWR, 37:377–382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved Guideline -
Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4]. Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2005).
3. Federal Occupational Safety and Health Administration. Bloodborne Pathogens
Standard. 29 CFR 1910. 1030.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Safety Instructions A-3

Protecting Yourself from Barcode Scanner Lasers


When using a hand-held barcode scanner, always observe the following
precautions:
• Never look directly at the beam of a hand-held barcode scanner.
• Never point the scanner at another person.
• Do not look at the reflection of the beam from a shiny surface.

Protecting Yourself from Electrical Hazards


When using Rapidlab 1200 system, always observe the following precautions:
• Do not operate the system in the presence of flammable anesthetic mixture
with air, O2, or nitrous oxide.
The risk of explosion exists in a potentially explosive environment.
• If you use an adapter, ensure the grounding wire is properly connected to a
permanent ground.
The system uses a grounded external power cord for connection to a grounded
electrical outlet.

02087462 Rev. V
A-4 Rapidlab 1200 Operator’s Guide: Safety Instructions

02087462 Rev. V
Appendix B: Service, Ordering, and Warranty

This section provides the following information:


• the address of the Siemens authorized representative, which is the Siemens
contact within the European community
• system warranty and service delivery policy information

Authorized Representative
Siemens Healthcare Diagnostics Ltd.
Sir William Siemens Sq.
Frimley, Camberley, UK GU16 8QD

Limited Instrument Warranty and Service Delivery Policy


Siemens and its authorized distributors may provide customers who acquire new
Siemens instruments with a limited warranty either in a specific agreement or in
standard language on their invoices. This limited warranty is designed to protect
customers from the cost associated with repairing instruments that exhibit
malfunctions due to defects in materials and/or workmanship during the warranty
period.
Siemens, at its election, provides warranty service either by providing repair
service of the instrument on site, or by exchanging the defective instrument or
component, subject to the limitations and exclusions set forth in Replacement of
Parts‚ page B-3 and Warranty and Service Exclusions‚ page B-4. Repairs,
replacements or exchanges of instruments or components provided during the
warranty or any additional service period, does not extend the warranty or service
period beyond the initially agreed upon period.
When the customer calls for service, the Siemens representative or authorized
distributor informs the customer of the type of service available for the customer’s
instrument, and instructs the customer as to how to obtain that service.

Warranty Period
The limited warranty period generally commences upon installation of the
original instrument at the customer’s location and extends for a period of
1 year thereafter, unless otherwise specifically agreed to by and between Siemens
(or its authorized distributors) and customer in a writing signed by duly authorized
representatives of both parties (sales representatives are generally not authorized
representatives of Siemens for these purposes).

02087462 Rev. V
B-2 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty

Additional Service Period


Customers, with some exceptions, may purchase additional service coverage beyond any
initial warranty period as part of the original instrument acquisition for second or
subsequent years beyond the original installation date. The customer’s original Purchase
Invoice or appropriate Agreement Addendum must indicate the term in months for
additional service coverage.

Service During Normal Hours


The customer may obtain service for instruments during normal business hours by
contacting the nearest Siemens location or authorized distributor. Refer to the list of
Siemens locations in this section.

Extent of a Service Call


Warranty or service calls generally include onsite repair or exchange of instruments or
components, travel to the location of the instrument, and onsite labor during normal
business hours. A warranty or service call is initiated by the customer by following the
instructions on how to obtain service for the customer’s instrument. The service call is
considered complete when any defects in material or workmanship have been corrected by
repair or replacement and the instrument conforms to the applicable specifications. When
service is complete, the customer receives a copy of the documentation detailing all work
performed by the Siemens representative or authorized distributor.

Service Outside Normal Hours


Customers, with some exceptions, may also request service to be delivered or an exchange
to be initiated outside normal business hours, including evenings, weekend days, or
nationally observed holidays, by contacting the nearest Siemens location or authorized
distributor. Service performed outside normal hours is subject to a surcharge unless the
customer has in place a service product option that provides service at the time requested.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-3

Replacement of Parts
In performing service, Siemens or its authorized distributors provide appropriate
parts to repair the instrument, or arrange for the exchange of the instrument or
affected parts, at no charge with the exception of certain parts or subassemblies
that are considered Customer Maintenance Items. Customer Maintenance Items
include, but are not limited to, the following items: lamps, electrodes or sensors
(which are covered by a separate warranty), reagents, calibrators, controls, paper,
and pens. Consult the appropriate system operator’s manuals for a complete list of
Customer Maintenance Items for any specific model of instrument.

Design Changes and Retrofitting of Instruments


Siemens reserves the right to change the design or construction of specific models
of instruments at any time without incurring any obligation to make such changes
available to individual customers or instruments. If Siemens notifies customers of
a change that improves the performance or reliability of their instrument, and
requests to retrofit that instrument, the customer must agree to allow Siemens or
an authorized distributor, at Siemens’s expense, to retrofit components or make
design changes, which does not adversely affect the instrument’s performance
characteristics.

Key Operator Designation


Each customer designates a key operator who is available to Siemens
representatives to describe instrument malfunctions by telephone and/or to
perform simple adjustments and corrections as requested. If a key operator is not
designated or is unavailable when the customer requests service, the delivery of
service may be delayed.

OSHA Requirements (US only)


When service is required at a customer location, the customer must provide the
Siemens representative with adequate facilities that comply with the regulations
of the Secretary of Labor under the Occupational Safety and Health Act (OSHA)
of 1970, as amended.

02087462 Rev. V
B-4 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty

Warranty and Service Exclusions


The following exclusions are in addition to any exclusions provided for in any written
warranty or service agreement.
IF ANY OF THE FOLLOWING EVENTS OCCUR, THE WARRANTY OR SERVICE
PROVISIONS DO NOT APPLY:
1. Repairs or modifications have been made to the instrument by someone other than an
authorized Siemens representative.
2. The instrument has been operated using accessories and supplies other than Siemens
brand accessories, or consumable supplies and/or reagents not having the same grade,
quality, and composition as defined in the system operator’s manuals.
3. Siemens has notified customers of a change that improves the performance or
reliability of their instrument and customer has not agreed to retrofit or make design
changes to the instrument.
4. Customer did not purchase the instrument from Siemens or one of its authorized
distributors.
5. The instrument has not been installed within 90 days of shipment to the customer’s
facility unless otherwise specified.
6. The customer has not performed appropriate customer maintenance procedures, as
outlined in the system operator’s manuals.
7. The instrument has been misused or used for a purpose for which it was not intended.
8. The instrument has been damaged in transit to the customer or damaged by the
customer while moving or relocating it without supervision by a Siemens
representative.
9. Damage was caused by floods, earthquakes, tornados, hurricanes, or other natural or
man-made disasters.
10. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil commotion.
11. Damage was caused by electrical surges or voltages exceeding the tolerances outlined
in the system operator’s manuals.
12. Damage was caused by water from any source external to the instrument.
13. The customer has purchased an alternative agreement whose terms of warranty or
service supersede these provisions.
Siemens or its authorized distributors can invoice customers, at current standard labor and
parts rates, for instruments repaired to correct damage or malfunctions due to any of the
reasons listed above.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-5

OTHER THAN AS STATED ABOVE, THERE ARE NO OTHER


WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE
INSTRUMENT, ITS SALE TO THE CUSTOMER, ITS LEASE TO THE
CUSTOMER, OR THE SALE OF THE INSTRUMENT TO THE CUSTOMER
AT THE EXPIRATION OR TERMINATION OF THE LEASE AGREEMENT.
SIEMENS SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR USE OR PURPOSE. SIEMENS LIABILITY FOR BREACH OF
ANY WARRANTY OR SERVICE AGREEMENT SHALL BE LIMITED ONLY
TO THE REPAIR OR REPLACEMENT OF DEFECTIVE EQUIPMENT AND
SHALL NOT INCLUDE ANY DAMAGES OF ANY KIND, WHETHER
DIRECT, INDIRECT, INCIDENTAL, CONTINGENT, OR CONSEQUENTIAL.
SIEMENS SHALL NOT BE LIABLE FOR DELAY FROM ANY CAUSE IN
PROVIDING REPAIR OR EXCHANGE SERVICE.
ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH
APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC
WRITTEN AGREEMENT DO NOT APPLY TO CUSTOMERS IN THOSE
JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS.

Copyright Information
The Rapidlab 1200 systems software incorporates a number of third-party
software applications under license to Siemens Healthcare Diagnostics, Inc. or
one of its affiliates. For those applications that request that certain information,
such as software headers, copyright notices, or software headers and copyright
notices, be distributed with the application, see the information listed below,
which is organized by application. The text in these sections is reproduced
verbatim.

GNU General Public License v.2


This product includes open source software. Such software is provided by
Siemens under the terms of the open source software licenses applicable to such
software, and is distributed WITHOUT ANY WARRANTY as set forth in the
corresponding licenses. Those terms require that Siemens provide the following
notices and information to the purchaser of this device. Versions of the GNU
General Public License (GPL) and Lesser General Public License (LGPL) are
available at www.gnu.org. Siemens will make the source code for such open
source software available upon request at cost from Siemens in accordance with
the terms of the relevant open source license.
For the VNC System distributed under GNU General Public License v.2:
Copyright (C) 1999 AT&T Laboratories Cambridge. All Rights Reserved.
For the JWSMTP Email Utility, jwSMTP library version 1.32 distributed under
GNU General Public License v.2 :

02087462 Rev. V
B-6 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty

Copyright (C) 2004 John Wiggins


Copyright (C) 2007 Siemens Healthcare Diagnostics

Baptize V1.0
Baptize
BAPTIZE V1.0
This tool sets the computername to the specified value without the need to reboot the
machine.
Usage:BAPTIZE new_name
After the program finished your computer is visible to others on the network under its new
name. BAPTIZE is tested to work with NetBEUI and TCP/IP.
NOTE:
Depending on the configuration of your computer this program may run for up to 1
minute. Don't get panic! During some amount of this time your computer may not be
visible on the network.
You may freely distribute this tool as long as you include this textfile and don't change
neither this textfile nor the code.
You can reach me at:
e-Mail:bec@advge.magwien.gv.at
CIS: 100112,3051
Jo.Berlakovich

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-7

BDM Download
A Background Debug Mode Driver Package for Motorola's 16- and 32-Bit
Microcontrollers
Scott Howard
February, 1993
The files in this archive are a PRELIMINARY RELEASE of a set of driver
functions, which allow control of the Background Debug Mode interface port of
any Motorola CPU16 or CPU32 microcontroller from the parallel printer port of
an IBM compatible computer. Source code in 'C', as well as object code and
example programs, are all included.
They accompany the forthcoming Motorola applications note of the same name.
You should have this app note in order to use these routines; the app note
documents the use of these functions, and documents the hardware interface
required by these routines.
All routines are Copyright (C) 1992 by Scott Howard, all rights reserved. Any
person or company is entitled to use this software and to make copies for others,
provided no charge is made for doing so. This software is distributed freely and
without warranty of any kind, not even implied warranty of suitability for any
particular use. The user of the software is solely responsible for determining
suitability for a particular purpose.
The user of this software agrees to hold Scott Howard, and Motorola Inc., its
employees, subsidiaries, agents, and distributors, blameless and free from
responsibility for any damages resulting from the use and/or malfunction of this
software, including direct and consequential damages and loss of income.
This is a preliminary release of these routines. You should have received with this
archive a printed preliminary copy of the applications note. If you did not, please
contact me and I will forward a copy.
This is free software, and it was written as a spare-time project. As such, it is
given away freely including source code, but there is no facility for Motorola or
myself to be able to provide support to users. If you need help, I will try to do my
best to support you, but please understand that the amount of time for this work is
limited and may only be available at irregular intervals.
Scott Howard
Motorola Semiconductor Products, Canada
Vancouver, B.C., Canada
POST: SCN088
Internet: Scott_Howard-SCN088@email.mot.com
Fax: +1-604-241-6290
February 1993

02087462 Rev. V
B-8 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty

Zip and Unzip


This is version 2005-Feb-10 of the Info-ZIP copyright and license.
The definitive version of this document should be available at
ftp://ftp.info-zip.org/pub/infozip/license.html indefinitely.
Copyright (c) 1990-2005 Info-ZIP. All rights reserved.
For the purposes of this copyright and license, "Info-ZIP" is defined as the following set of
individuals:
Mark Adler, John Bush, Karl Davis, Harald Denker, Jean-Michel Dubois,
Jean-loup Gailly, Hunter Goatley, Ed Gordon, Ian Gorman, Chris Herborth, Dirk
Haase, Greg Hartwig, Robert Heath, Jonathan Hudson, Paul Kienitz, David
Kirschbaum, Johnny Lee, Onno van der Linden, Igor Mandrichenko, Steve P. Miller,
Sergio Monesi, Keith Owens, George Petrov, Greg Roelofs, Kai Uwe Rommel, Steve
Salisbury, Dave Smith, Steven M. Schweda, Christian Spieler, Cosmin Truta, Antoine
Verheijen, Paul von Behren, Rich Wales, Mike White
This software is provided "as is," without warranty of any kind, express or implied. In no
event shall Info-ZIP or its contributors be held liable for any direct, indirect, incidental,
special or consequential damages arising out of the use of or inability to use this software.
Permission is granted to anyone to use this software for any purpose, including
commercial applications, and to alter it and redistribute it freely, subject to the following
restrictions:
1. Redistributions of source code must retain the above copyright notice, definition,
disclaimer, and this list of conditions.
2. Redistributions in binary form (compiled executables) must reproduce the above
copyright notice, definition, disclaimer, and this list of conditions in documentation
and/or other materials provided with the distribution. The sole exception to this
condition is redistribution of a standard UnZipSFX binary (including SFXWiz) as part
of a self-extracting archive; that is permitted without inclusion of this license, as long
as the normal SFX banner has not been removed from the binary or disabled.
3. Altered versions – including, but not limited to, ports to new operating systems,
existing ports with new graphical interfaces, and dynamic, shared, or static library
versions--must be plainly marked as such and must not be misrepresented as being the
original source. Such altered versions also must not be misrepresented as being
Info-ZIP releases – including, but not limited to, labeling of the altered versions with
the names "Info-ZIP" (or any variation thereof, including, but not limited to, different
capitalizations), "Pocket UnZip," "WiZ" or "MacZip" without the explicit permission
of Info-ZIP. Such altered versions are further prohibited from misrepresentative use
of the Zip-Bugs or Info-ZIP e-mail addresses or of the Info-ZIP URL(s).
4. Info-ZIP retains the right to use the names "Info-ZIP," "Zip," "UnZip," "UnZipSFX,"
"WiZ," "Pocket UnZip," "Pocket Zip," and "MacZip" for its own source and binary
releases.

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty B-9

Contacts
This section provides the following information:
• the address of the Siemens authorized representative, which is the Siemens
contact within the European community
• addresses for obtaining service and technical information and for ordering
supplies

Authorized Representative
Siemens Healthcare Diagnostics Ltd.
Sir William Siemens Sq.
Frimley, Camberley, UK GU16 8QD

Addresses
For technical assistance contact your local technical support provider. For
customer service or additional information contact your local technical support
distributor. www.siemens.com/diagnostics

Siemens Healthcare
Diagnostics Pty Ltd
885 Mountain Highway
Bayswater Victoria 3153
Australia

02087462 Rev. V
B-10 Rapidlab 1200 Operator’s Guide: Service, Ordering, and Warranty

02087462 Rev. V
Appendix C: System Fluids

Recommended Fill Volumes


You can analyze samples with the Rapidlab 1200 systems using the sample
collection devices listed in the following table. Always use the recommended
minimum fill volumes for the sample devices. This ensures that the systems can
aspirate sufficient sample for analysis.
Sample Device Sampling Mode Minimum Fill Volume
1-mL syringe All parameters (default) 100 µL (1240 systems)
Microsample 150 µL (1245, 1260 systems)
pH and pH, Glu, Lac 200 µL (1265 systems)
tHb
3-mL syringe All parameters (default) 200 µL for all systems in all
Microsample modes
pH and pH, Glu, Lac
tHb
5-mL syringe All parameters (default) 500 µL for all systems in all
Microsample modes
pH and pH, Glu, Lac
tHb
Capillary tube All parameters (default) 90 µL (1240 systems)
140 µL (1245 systems)
125 µL (1260 systems)
175 µL (1265 systems)
Microsample 55 µL (1240, 1245 systems)
95 µL (1260, 1265 systems)
pH and pH, Glu, Lac 35 µL (1240, 1245 systems)
95 µL (1260, 1265 systems)
tHb 100 µL (1245, 1265 systems)

02087462 Rev. V
C-2 Rapidlab 1200 Operator’s Guide: System Fluids

Rapidlab 1200 Cartridges


Each of the cartridges has an install-by date on the label.
Cartridge Stability Use life Storage temperature
Reagent 30 days Calibration dependent 2° to 8°C
cartridge Room temperature not to
exceed 25°C, up to 7 days
Wash Cartridge 18 days Sample dependent Room temperature at
Rapidlab 1245 30 samples per day = 12 approximately 25°C
and 1265 days of use
Wash Cartridge 18 days Sample dependent Room temperature at
Rapidlab 1240 30 samples per day = 17 approximately 25°C
and 1260 days of use
AutomaticQC 28 days sample dependent 2° to 8°C
cartridge at least 1 sample analysis
of each level, 3 times per
day

02087462 Rev. V
Appendix D: Supplies

Use this table to locate the supplies you need to order.


Item REF
Wash cartridge kit (2) 03913056
Reagent cartridge kit 03909458
AutomaticQC cartridge kit 05293926
Waste bottle kit (4) 06641057
Printer paper 01719376
Paper roll spindle 00792177
Printer paper cover 09340910
Sample port/capillary kit (20 pack) 04142460
Conditioner kit (5 pack) 02578644
Deproteinizer kit (10 pack) 08915030
Clot removal kit 13078229
Aspiration adapter (30) 04889515
Tubing kit (common) 06645048
Tubing kit, CO-ox 06645648
CO-ox sample chamber 06324604
Air filter (2) 03168350
Reagent manifold (1240 1260) 06646415
Reagent manifold (1245, 1265) 06643971
AQC manifold 06647195
Quick adapter (100) 09320618
Barcode scanner kit 10379796
Cable, Rapidlab 1200 to Rapidlink or Rapidcomm 03480125
Fuses (2) 07167332
Reference sensor 06449458
Reference sensor refill (cassette, fill solution, O-rings) 06451843
Reference inner 09388182
pH Ready sensor 10376877
pCO2 Ready sensor 05065729
pO2 Ready sensor 05065575

Na+ Ready sensor 10376878

02087462 Rev. V
D-2 Rapidlab 1200 Operator’s Guide: Supplies

Item REF
K+ Ready sensor 10376879

Ca++ Ready sensor 01428622


Cl¯ Ready sensor 10376880
Glu sensor 04442537
Lac sensor 01664482
Sample Ground/Temperature sensor 06195871
Test/Blank sensor pO2/pCO2 (TB1) 02195443

Test/Blank sensor pH/Na+ (TB2) 05147202

Test/Blank sensor K+/Ca++/Cl¯ (TB3) 00768594


Test/Blank sensor ref (TB5) 08053446
Test/Blank sensor glucose and lactate (TB4) 02274653
Electrode Fill Solution, pH 10376881
Electrode Fill Solution, Na+, K+, Ca++, Cl¯ 10376882
Electrode Fill Solution, Reference 02563698
High G/L 09733092
RapidQC Complete, level 1 02017464
RapidQC Complete, level 2 07519905
RapidQC Complete, level 3 07182730
Lamp assembly, CO-ox 06650153
Power cord, US 03628246
Power cord, UK 06139440
Power cord, Europe 06048720
Multicap® 100 μL (50) 05974729
Multicap 100 μL (500) 05614986
Multicap 140 μL (50) 01198961
Multicap 140 μL (500) 06493996
Multicap 175 μL (50) 07162853
Multicap 175 μL (500) 01519512
Multicap-S Plastic Capillaries μL (50 x 100) 00335434
Multicap-S Plastic Capillaries μL (500 x 100) 05656514
Multicap-S Plastic Capillaries μL (50 x 140) 04549544
Multicap-S Plastic Capillaries μL (500 x 140) 00325811
Multicap-S Plastic Capillaries μL (50 x 175) 06440221
Multicap-S Plastic Capillaries μL (500 x 175) 02043295

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Supplies D-3

Item REF
Caps (100) 01558100
Caps (200) 08685906
CD, Rapidlab 1200 Interface Specification 06621307
Guide, Rapidlab 1200 Operator’s, English 06621382
Guide, Rapidlab 1200 Operator’s, French 06622214
Guide, Rapidlab 1200 Operator’s, German 06624454
Guide, Rapidlab 1200 Operator’s, Italian 06626058
Guide, Rapidlab 1200 Operator’s, Spanish 06625361
Guide, Rapidlab 1200 Operator’s, Portuguese 06628093
Guide, Rapidlab 1200 Operator’s, Swedish 06629243
Guide, Rapidlab 1200 Operator’s, Japanese 06630926
Guide, Rapidlab 1200 Operator’s, Finnish 02002904
Guide, Rapidlab 1200 Operator’s, Danish 03322392
Guide, Rapidlab 1200 Operator’s, Greek 06856925
Guide, Rapidlab 1200 Operator’s, Polish 06856933
CD, Rapidlab 1200 Operator’s Guide 06631302

02087462 Rev. V
D-4 Rapidlab 1200 Operator’s Guide: Supplies

02087462 Rev. V
Appendix E: System Specifications

The following table lists the specifications for the Rapidlab 1200 systems.
Table E-1 Rapidlab 1200 System Specifications
Property Specification
Ambient operating temperature 15–32°C
Ambient temperature change less than 4°C per hour
Ambient operating relative humidity 5–90%, non-condensing
Ambient shipping temperature -25–45°C
Ambient storage temperature 4–45°C
Power rating 150VA
Voltage requirements 100V/240V (85V to 264V autoranging)
50/60Hz
Ambient operating barometric 523–800 mmHg (69.7–106.7 kPa)
pressure
System dimensions, base model height 61.0 cm (24 inches)*
width 53.5 cm (21 inches)
depth 58.5 cm (23 inches)
weight 29.5 kg (65 lbs)
* Height with screen fully upright

Viewing Parameter Measurements


The following table lists the units, reporting ranges, and display resolutions for the
pH and blood gas parameters measured by the Rapidlab 1200 system.
Table E-2 pH and Blood Gas Parameters
Parameter Units Reporting Range Resolution
pH pH 6.000–8.000 0.001
H+ nmol/L 10.0–1000.0 0.1
pCO2 mmHg 5.0–250.0 0.1
kPa 0.67–33.33 0.01
pO2 mmHg 0–800 0.1
kPa 0.0–106.67 0.01
pAtm mmHg 523–800 1
kPa 69.7–106.6 0.1

02087462 Rev.V
E-2 Rapidlab 1200 Operator’s Guide: System Specifications

The following table lists the units, reporting ranges, and display resolutions for the
electrolyte parameters measured or calculated by the Rapidlab 1200 systems.
Table E-3 Electrolyte and Metabolite Parameters
Parameter Units Reporting Range Resolution
Na+ mmol/L 70.0–200.0 0.1

K+ mmol/L 0.50–20.00 0.01

Ca++ mmol/L 0.25–5.00 0.01


mg/dL 1.0–20.0 0.1
Ca++(7.4) mmol/L 0.10–5.70 0.01
mg/dL 0.4–22.8 0.1
Cl- mmol/L 40–160 1
Glucose mg/dL 10–998 1
mmol/L 0.6–55.4 0.1
Lactate mmol/L 0.00–30.00 0.01
mg/dL 0.0–270.2 0.1
AnGap mmol/L -5.0–50.0 0.1

The following table lists the units, reporting ranges, and display resolutions for the
oxygenation parameters calculated by the Rapidlab 1200 systems.
Table E-4 Oxygenation Parameters
Parameter Units Reporting Range Resolution
p50 mmHg 15.0–75.0 0.1
kPa 2.00–10.00 0.01
ctO2(a) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.9 0.1
ctO2(v) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.9 0.1
ctO2( ) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.9 0.1
O2SAT(est) % 15.0–100.0 0.1
decimal fraction 0.15–1.000 0.001
pO2/FIO2 mmHg/% 0.25–7.00 0.01
kPa/% 0.033–0.933 0.001
O2CT(est) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.8 0.1
ctO2(a- ) mL/dL 0.0–20.0 0.1
mL/L 0–200 1
mmol/L 0.0–8.9 0.1

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-3

Table E-4 Oxygenation Parameters


Parameter Units Reporting Range Resolution
ctO2([a- ]/a) % 0–100 1
decimal fraction 0.00–1.00 0.01

O2 mL/min 0–3500 1
L/min 0.00–3.50 0.01
mmol/min 0–156.2 0.1
mL/min 0–3500 1
O2
L/min 0.00–3.50 0.01
mmol/min 0–156.2 0.1
The following table lists the units, reporting ranges, and display resolutions for
parameters measured by the Rapidlab 1200 systems CO-ox module.
Table E-5 CO-ox Module Parameters
Parameter Units Reporting Range Resolution
tHb g/dL 2.0–25.0 0.1
g/L 20–250 1
mmol/L 1.2–15.5 0.1
FO2Hb % (blood) 0.0 100.0 0.1
% (QC) 0.0 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
FCOHb % (blood) 0.0−100.0 0.1
% (QC) 0.0 ± 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
FMetHb % (blood) 0.0−100.0 0.1
% (QC) 0.0 ± 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
FHHb % (blood) 0.0−100.0 0.1
% (QC) 0.0 ± 200.0 0.1
fraction (blood) 0.000−1.000 0.001
fraction (QC) 0.000 ± 2.000 0.001
sO2 % 15.0–100 0.1
fraction 0.15–1.000 0.001
Hct % 6–74 1
fraction 0.06–0.74 0.01
BO2 (O2CAP) mL/dL 0.0–40.0 0.1
mL/L 0–400 1
mmol/L 0.0–17.9 0.1

02087462 Rev.V
E-4 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-5 CO-ox Module Parameters


Parameter Units Reporting Range Resolution
ctO2(Hb) mL/dL 0–40.0 0.1
mL/L 0–400 1
mmol/L 0–17.9 0.1
The following table lists the units, reporting ranges, and display resolutions for the
temperature corrected and respiratory parameters calculated by the Rapidlab 1200
systems.
Table E-6 Temperature Corrected and Respiratory Parameters
Parameter Units Reporting Range Resolution
pH(T) pH 6.000–8.000 0.001
H+(T) nmol/L 10.0–1000.0 0.1
pCO2(T) mmHg 5.0–250.0 0.1
kPa 0.67–33.33 0.01
pO2(T) mmHg 0.0–800.0 0.1
kPa 0.00–106.66 0.01
pO2(A-a)(T) mmHg 0–999.9 0.1
kPa 0.00–133.31 0.01
pO2(a/A)(T) % 0–100 1
decimal fraction 0.00–1.00 0.01
RI(T) % 0–2000 1
decimal fraction 0.00–20.00 0.01

sp/ t(T) % 0–100 1


decimal fraction 0.00–1.00 0.01

sp/ t(est, T) % 0–100 1


decimal fraction 0.00–1.00 0.01

The following table lists the units, reporting ranges, and display resolutions for the
metabolic parameters calculated by the Rapidlab 1200 systems.
Table E-7 Metabolic Parameters
Parameter Units Reporting Range Resolution
HCO3-act mmol/L 0.0–99.9 0.1

HCO3-std mmol/L 0.0–99.9 0.1

ctCO2 mmol/L 0.0–99.9 0.1


BE(B) mmol/L -99.9–99.9 0.1
BE(ecf) mmol/L -99.9–99.9 0.1

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-5

The following table lists the units, reporting ranges, and display resolutions for the
parameters that can be entered into the Rapidlab 1200 systems.
Table E-8 Entered Parameters
Parameter Units Reporting Range Resolution
Temperature °C 10.0–43.9 0.1
°F 50.0–111.0 0.1
FIO2 % 15.0–100.0 0.1
decimal fraction 0.150–1.000 0.001
ctHb g/dL 2.0–25.0 0.1
g/L 20–250 1
mmol/L 1.2–15.5 0.1
Qt L/min 0.00–30.00 0.01
OBF 1.35–1.40 0.01
Flow L/min 0.00–99.99 0.01
Resp Rate b/min 0.0–100.0 0.1

Understanding System Limitations


The manufacturer cannot guarantee system performance when any of the
following situations occur. Specific terms of warranty, service, and contract
agreements may be invalidated if any of these situations occur.
• you exceed the expiration dates of cartridges
• you do not use cartridges according to the manufacturer’s recommendations
• you do not follow standard laboratory practices
• you do not follow the procedures described in this guide
• you do not follow the environmental operating conditions and location
recommendations

02087462 Rev.V
E-6 Rapidlab 1200 Operator’s Guide: System Specifications

Interference Testing
Interference Testing for Rapidlab 1200 Sensors
Siemens performed interference testing to demonstrate the specificity of the system
sensors.
The results from each of the studies were tabulated and the simple average effect was
determined for each interfering compound. The Effect of Interference column
demonstrates the apparent change in result as a function of introducing the interfering
compound. In several instances multiple tests were performed on an interfering substance
as well as several levels of interfering substance.
The effect of the potential interfering substance on results is summarized in the following
table. The table shows the interference level tested along with the average change in blood
results (test result spiked - control result unspiked) for each of the sensors.
Effect of
Interference Interference
Analyte (units) Interference Level Tested (Test - control)
pH (pH units) Acetaminophen 20 mg/dL 0.000
Sodium Pentothal 300 mg/dL -0.009
Salicylic Acid 20 mg/dL 0.000
pO2 (mm Hg) Isoflurane 3% 0.15
Halothane 3% 0.05
Nitrous Oxide 84% 2.8
pCO2 (mm Hg) Ibuprofen 40 mg/dL 0.35
Sodium Pentothal 300 mg/dL 1.34
Na+ (mmol/L) Acetaminophen 2 mg/dL 0.00
Dobutamine 20 mg/dL 0.37
Dobutamine 10 mg/dL 0.15
Dobutamine 5 mg/dL 0.20
Na+ (mmol/L) Vancomycin 63 µg/dL -0.23
Ofloxacin 6 µg/dL -0.14
Perphenazine 1.25 µg/mL 0.05
Sodium Pentothal 300 mg/dL -0.88
K+ (mmol/L) Sodium Pentothal 300 mg/dL -0.016

Cl- (mmol/L) Heparin 90 units/mL 0.5


Salicylic Acid 30 mg/dL 1.0
Salicylic Acid 20 mg/dL 0.7

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-7

Effect of
Interference Interference
Analyte (units) Interference Level Tested (Test - control)
Acetylsalicylic 50 mg/dL 0.5
Acid
Acetaminophen 2 mg/dL 0.0
Sodium Pentothal 300 mg/dL -1.0
Ca++ (mmol/L) Acetaminophen 2 mg/dL -0.03
Ibuprofen 40 mg/dL -0.03
Salicylic Acid 20 mg/dL -0.04
Salicylic Acid 30 mg/dL -0.40
Sodium Pentothal 300 mg/dL -0.01
Ca++ (mmol/L) Acetylsalicylic 50 mg/dL 0.04
Acid
Acetylsalicylic 30 mg/dL 0.01
Acid
Acetylsalicylic 15 mg/dL 0.01
Acid
Glucose (mg/dL) Acetaminophen 2 mg/dL -11.8
Heparin 90 units/mL 7.8
Salicylic Acid 30 mg/dL -0.5
Salicylic Acid 20 mg/dL -0.3
Ethanol 350 mg/dL -1.5
Dopamine 10 mg/dL -12.6
Dopamine 5 mg/dL 12.5
Dobutamine 20 mg/dL -9.5
Dobutamine 10 mg/dL -5.5
Dobutamine 5 mg/dL -2.0
Acetylsalicylic 50 mg/dL -1.5
Acid
Sodium Pentothal 300 mg/dL -0.9
pO2 25–85 mm Hg -1.0
Pralidoxime Iodide 16 µg/mL *

Lactate (mmol/L) Chlorpromazine 17 mg/dL < +/-0.3


Dopamine 1 mg/dL < +/-0.3
Ethanol 350 mg/dL < +/-0.3
Salicylate 50 mg/dL < +/-0.3

02087462 Rev.V
E-8 Rapidlab 1200 Operator’s Guide: System Specifications

Effect of
Interference Interference
Analyte (units) Interference Level Tested (Test - control)
Sodium 70 mg/dL < +/-0.3
Nitroprusside
Thiocyanate 80 mg/dL < +/-0.3
Heparin 20,000 U/dL < +/-0.3
Epinephrine 2 mg/dL < +/-0.3
Norepinephrine 2 mg/dL < +/-0.3
Phenobarbital 15 mg/dL < +/-0.3
Glutamate 16 mg/dL < +/-0.3
Hetastarch 30% < +/-0.3
Acetoacetate 40 mg/dL < +/-0.3
Ascorbate 8 mg/dL < +/-0.3
Dilantin 14 mg/dL < +/-0.3
Bilirubin (Direct) 30 mg/dL < +/-0.3
Bilirubin (Total) 35 mg/dL < +/-0.3
Pralidoxime Iodide 64 µg/mL †

Creatinine 30 mg/dL < +/-0.3


Hydroxybutyrate 200 mg/dL < +/-0.3
Urea 500 mg/dL < +/-0.3
Guaiacol 5 mg/dL < +/-0.3
Pyruvate 9 mg/dL < +/-0.3
Theophylline 9 mg/dL < +/-0.3
Penicillamine 25 mg/dL < +/-0.3
Isoniazid 2 mg/dL < +/-0.3
Uric Acid 10 mg/dL < +/-0.3
Citrate 1000 mg/dL < +/-0.3
Potassium Oxalate 1000 mg/dL < +/-0.3
EDTA 800 mg/dL < +/-0.3
Sodium Fluoride 1000 mg/dL 1.0
Sodium Fluoride/ 1000 mg/dL 1.0
Potassium Oxalate
Acetominophen 2 mg/dL 0.35
* Glucose system performance will be out of specification when PAM levels exceed
16 µg/mL.
† Lactate system performance will be out of specification when PAM levels exceed
64 µg/mL.

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-9

Interference Testing for Rapidlab 1200 CO-oximetry


Siemens performed interference testing to demonstrate the specificity of the
Rapidlab 1200 systems CO-oximetry module.
The table shows the interference level tested along with the average change in
blood results (test result spiked - control result unspiked) for each of the sensors.
The probability of the mean effect being zero was calculated, and those with less
than a 5% chance (p < 0.05) were considered statistically significant. For those
effects which were statistically significant, a mean effect > 0.5 g/dL for tHb or >
1.0% for the CO-ox fractions was considered clinically significant.
The reported effects for methylene blue at 25 and 40 mg/L are the simple mean
effect (spiked mean–control mean). For sulfhemoglobin, the mean effect was
corrected using the difference observed between the spike and control from an
additional reference method (gas chromatography or mass spectrophotometry
depending on analyte) which was not subject to interference. Sample preparation
differences alone, between the spiked and control samples, accounted for some of
the observed differences and by subtracting out that contribution using the
reference method, the true interference can be estimated.

02087462 Rev.V
E-10 Rapidlab 1200 Operator’s Guide: System Specifications

Interference Testing Results for tHb, FO2Hb, FCOHb,


FMetHb, and FHHb
Potential Interferent Level Tested Effect of Interference
Lipid 5% Intralipid in serum No effect
Bilirubin 40 mg/dL No effect
Fetal Hemoglobin 20, 40, 85% No effect
CyanMethemoglobin 10% No effect
Beta-carotene 40 mg/dL No effect
Hemolysis 10% volume No effect
Evans Blue 5 mg/L No effect
Indocyanine Green 5 mg/dL No effect
Methylene Blue 25 mg/dL FO2Hb -1.2%
FCOHb +1.3%
Methylene Blue 40 mg/dL FO2Hb -2.0%
FCOHb +2.0%
Sulfhemoglobin 10% tHb -0.8 g/dL
FO2Hb -6.1%
FCOHb +3.6%
FMetHb +1.4%
FHHb +1.7%

Irenat (Sodium Perchlorate) Interference when Measuring


Ionized Calcium
Samples containing Irenat (sodium perchlorate) can cause interference when measuring
ionized calcium because Irenat can falsely lower ionized calcium results. The results for
patients treated with Irenat to prevent Hyperthyroidism when using X-ray contrast
medications show discrepancies when compared with typical ionized calcium results.
Irenat blocks the anionic iodide transporter in the thyroid.
Low PTH and hypocalcemia are possible outcomes after thyroid surgery. Therefore
ionized calcium can not be tested to detect hypocalcemia while Irenat is still in the system.
The following guidelines should be followed if a patient is on Irenat when ionized calcium
is measured:
• Measure Ca++ before administering Irenat.
• Do not measure Ca++ while the patient is on Irenat.
• Ca++ may be measured 96 hours after the last dose of Irenat.

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-11

NOTE: This interferent is patient- and sample-specific and does not result in
interference to subsequent measurements of other samples on the calcium sensor.
There is no impact to sensor calibration or sensitivity, and other samples that are
run immediately after the Irenat patient sample can be run without impact.

Ethylene Glycol Interference when Measuring Lactate


and Glucose
Falsely elevated lactate results may be reported as a result of non-specificity of the
lactate oxidase enzyme towards ethylene glycol metabolites. Falsely decreased
glucose results may also be reported.

Performance Characteristics
This section contains performance characteristics for each Rapidlab 1200 system
in the series. Each system contains performance data within the following criteria:
• precision on Controls
• recovery and Precision Values–as appropriate to the system
• method Comparison with Human Whole Blood Samples

Rapidlab 1240 System Performance Characteristics


All performance data presented in this section was generated using the
Rapidlab 1240 system. The system performed calibrations using the default
settings recommended by Siemens for optimum performance. All reported values
were corrected to 760 mmHg. All data was collected at room temperature (about
23°C). You should determine your own performance characteristics in your
laboratory with your Rapidlab 1240 system.

Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC)
were analyzed on the Rapidlab 1240 system. Manual QC is performed by the
operator while AutomaticQC is performed automatically by the system based on
the QC frequency defined in the system software. The results are presented here.
Precision on manual aqueous quality control materials was estimated using a
minimum of 3 Rapidlab 1240 systems. Controls were measured over a minimum
of 10 days.
Precision on the aqueous quality control materials in the AutomaticQC module
was estimated using a minimum of 3 Rapidlab 1240 systems over a minimum of
10 days. AutomaticQC is automatically scheduled to run (single sample)
independently 3 times per day.

02087462 Rev.V
E-12 Rapidlab 1200 Operator’s Guide: System Specifications

The following tables summarize the results of the Rapidlab 1240 system precision for
manual QC and AutomaticQC.
Table E-9 Rapidlab 1240 Manual QC Precision Results

Analyte Level n Mean WRSD* Total SD†


pH 1 162 7.121 0.001 0.001
pH 2 161 7.331 0.001 0.002
pH 3 160 7.534 0.001 0.002
pCO2 1 162 70.8 0.49 0.97
pCO2 2 161 40.3 0.30 0.48
pCO2 3 160 23.0 0.21 0.31
pO2 1 162 147.4 0.71 1.72
pO2 2 161 97.6 0.73 1.21
pO2 3 160 23.8 0.94 1.10
* WRSD = within-run standard deviation
† Total SD = total standard deviation

Table E-10 Rapidlab 1240 AutomaticQC Precision Results

Analyte Level n Mean WRSD* Total SD†


pH 1 161 7.156 0.001 0.001
pH 2 163 7.358 0.001 0.001
pH 3 158 7.559 0.001 0.002
pCO2 1 162 66.5 1.02 1.20
pCO2 2 163 38.6 0.37 0.58
pCO2 3 159 21.7 0.45 0.52
pO2 1 163 153.5 0.74 0.92
pO2 2 163 104.0 0.93 0.95
pO2 3 160 68.2 1.19 1.32
* WRSD = within-run standard deviation
† Total SD = total standard deviation

Recovery and Precision of Blood Gases in Human Whole Blood


To prepare samples for analysis, blood was collected in heparinized vacuum tubes and
tonometered at 37ºC for each of 6 levels for pH and 9 levels for pCO2/ pO2. Multiple runs
were performed using these samples on a minimum of 3 Rapidlab 1240 systems.

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-13

The following tables summarize the results of the Rapidlab 1240 system recovery
and precision testing:
Table E-11 Rapidlab 1240 Recovery and Precision Testing—pH

Level Mode n WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.004 7.042 7.032 100.15 0.05
2 Capillary 24 0.002 7.204 7.202 100.02 0.03
3 Capillary 20 0.006 7.349 7.354 99.94 0.09
4 Capillary 24 0.004 7.409 7.41 99.99 0.05
5 Capillary 24 0.002 7.516 7.534 99.76 0.03
6 Capillary 24 0.004 7.662 7.63 100.42 0.05
1 Syringe 48 0.004 7.034 7.032 100.04 0.06
2 Syringe 48 0.005 7.209 7.202 100.09 0.07
3 Syringe 47 0.003 7.353 7.354 99.99 0.05
4 Syringe 48 0.003 7.418 7.41 100.11 0.04
5 Syringe 48 0.004 7.545 7.534 100.15 0.05
6 Syringe 47 0.003 7.621 7.63 99.88 0.04
1 Micro- 24 0.01 7.03 7.032 99.97 0.14
capillary
2 Micro- 24 0.013 7.204 7.202 100.02 0.18
capillary
3 Micro- 24 0.011 7.359 7.354 100.07 0.15
capillary
4 Micro- 24 0.012 7.403 7.41 99.91 0.16
capillary
5 Micro- 24 0.007 7.538 7.534 100.05 0.09
capillary
6 Micro- 24 0.006 7.629 7.63 99.98 0.08
capillary
1 Micro- 24 0.004 7.031 7.032 99.98 0.05
syringe
2 Micro- 24 0.002 7.197 7.202 99.92 0.03
syringe
3 Micro- 24 0.006 7.356 7.354 100.03 0.08
syringe
4 Micro- 24 0.003 7.418 7.41 100.1 0.05
syringe
5 Micro- 24 0.005 7.556 7.534 100.28 0.06
syringe
6 Micro- 24 0.003 7.628 7.63 99.97 0.04
syringe

02087462 Rev.V
E-14 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-11 Rapidlab 1240 Recovery and Precision Testing—pH

Level Mode n WRSD* Observed Expected Recovery WRCV


1 pH Only 24 0.014 7.031 7.032 99.99 0.2
Capillary
2 pH Only 21 0.007 7.221 7.202 100.27 0.1
Capillary
3 pH Only 24 0.005 7.371 7.354 100.24 0.06
Capillary
4 pH Only 21 0.006 7.434 7.41 100.32 0.08
Capillary
5 pH Only 24 0.006 7.551 7.534 100.22 0.08
Capillary
6 pH Only 21 0.004 7.657 7.63 100.35 0.05
Capillary
1 pH Only 42 0.004 7.008 7.032 99.65 0.05
Syringe
2 pH Only 48 0.003 7.181 7.202 99.7 0.04
Syringe
3 pH Only 46 0.005 7.336 7.354 99.76 0.07
Syringe
4 pH Only 48 0.003 7.388 7.41 99.7 0.03
Syringe
5 pH Only 42 0.004 7.506 7.534 99.62 0.06
Syringe
6 pH Only 45 0.004 7.621 7.63 99.88 0.06
Syringe
* WRSD = within-run standard deviation

Table E-12 Rapidlab 1240 Recovery and Precision Testing—pCO2

Level Mode n WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.17 7.1 7.1 99.1 2.4
2 Capillary 24 0.42 22.6 21.4 105.6 1.9
3 Capillary 24 0.8 27.1 28.6 94.7 3
4 Capillary 24 0.55 34.8 35.6 97.8 1.6
5 Capillary 24 0.78 50.5 50 101.1 1.5
6 Capillary 24 1.71 68.4 71.4 95.8 2.5
7 Capillary 24 1.25 97 99.8 97.2 1.3
8 Capillary 24 3.64 128.1 135.7 94.4 2.8
9 Capillary 24 6.27 212.5 228 93.2 3
1 Syringe 48 0.23 7 7.2 97.8 3.2

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-15

Table E-12 Rapidlab 1240 Recovery and Precision Testing—pCO2

Level Mode n WRSD* Observed Expected Recovery WRCV


2 Syringe 48 0.39 22.7 21.5 105.7 1.7
3 Syringe 45 0.59 26.7 28.6 93.3 2.2
4 Syringe 48 0.81 36.3 35.4 102.5 2.2
5 Syringe 48 1.08 50.8 50.1 101.4 2.1
6 Syringe 45 1.79 70.7 71.5 98.8 2.5
7 Syringe 48 1.97 99.8 99.1 100.7 2
8 Syringe 48 4.35 130.3 135.9 95.9 3.3
9 Syringe 47 5.59 222.7 226.5 98.3 2.5
1 Micro- 12 0.42 7.2 7.1 100.7 5.8
capillary
2 Micro- 12 0.74 21.3 21.4 99.5 3.5
capillary
3 Micro- 12 0.42 24.5 28.5 85.9 1.7
capillary
4 Micro- 12 0.33 33.3 35.7 93.4 1
capillary
5 Micro- 12 0.85 49.5 49.9 99 1.7
capillary
6 Micro- 12 1.12 67.6 71.3 94.9 1.7
capillary
7 Micro- 12 1.23 100.1 99.9 100.2 1.2
capillary
8 Micro- 12 2.22 134.2 135.6 99 1.7
capillary
9 Micro- 12 6.69 228.9 228.3 100.2 2.9
capillary
1 Micro- 24 0.36 6.9 7.2 96.3 5.3
syringe
2 Micro- 24 0.38 21.4 21.2 100.7 1.8
syringe
3 Micro- 24 1.26 26.2 28.3 92.7 4.8
syringe
4 Micro- 24 0.82 34.1 35.8 95.2 2.4
syringe
5 Micro- 24 1.09 50.5 50.1 100.8 2.2
syringe
6 Micro- 24 2.02 69.8 70.8 98.7 2.9
syringe

02087462 Rev.V
E-16 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-12 Rapidlab 1240 Recovery and Precision Testing—pCO2

Level Mode n WRSD* Observed Expected Recovery WRCV


7 Micro- 24 1.91 101.7 100.2 101.5 1.9
syringe
8 Micro- 24 2.97 138.3 136 101.7 2.1
syringe
9 Micro- 24 6.74 241.4 229 105.4 2.8
syringe
* WRSD = within-run standard deviation

Table E-13 Rapidlab 1240 Recovery and Precision Testing—pO2

Level Mode n WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.34 27.9 28.6 97.7 1.2
2 Capillary 24 0.35 52 50 104 0.7
3 Capillary 24 0.89 87.7 85.5 102.5 1
4 Capillary 24 1.47 101.4 107.1 94.7 1.5
5 Capillary 24 0.79 153.7 149.6 102.7 0.5
6 Capillary 24 4.02 198 199.9 99 2
7 Capillary 24 1.53 254.1 249.4 101.9 0.6
8 Capillary 24 4.87 374.8 378.4 99 1.3
9 Capillary 24 10.28 630 649.7 97 1.6
1 Syringe 45 0.36 28.1 28.6 98 1.3
2 Syringe 48 0.42 52.5 50.1 104.9 0.8
3 Syringe 48 0.6 88.2 84.9 103.9 0.7
4 Syringe 48 1.15 103.2 107.3 96.2 1.1
5 Syringe 48 1.13 153.7 148.6 103.4 0.7
6 Syringe 45 2.26 196.2 200.3 98 1.2
7 Syringe 47 3.81 253.9 247.7 102.5 1.5
8 Syringe 48 4.69 379.5 379.2 100.1 1.2
9 Syringe 48 9.97 636.6 651.1 97.8 1.6
1 Micro- 12 0.21 30.7 28.5 107.5 0.7
capillary
2 Micro- 12 0.35 54 49.9 108 0.6
capillary
3 Micro- 12 0.7 95.1 85.6 111 0.7
capillary
4 Micro- 12 0.64 106.7 107 99.7 0.6
capillary

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-17

Table E-13 Rapidlab 1240 Recovery and Precision Testing—pO2

Level Mode n WRSD* Observed Expected Recovery WRCV


5 Micro- 12 0.66 159.9 149.8 106.7 0.4
capillary
6 Micro- 12 1.72 199.9 199.5 100.2 0.9
capillary
7 Micro- 12 2.09 265 249.7 106.1 0.8
capillary
8 Micro- 12 2.71 371 377.6 98.2 0.7
capillary
9 Micro- 12 6.27 632.5 649.3 97.4 1
capillary
1 Micro- 24 0.17 30.4 28.3 107.2 0.6
syringe
2 Micro- 24 0.33 54 50.1 107.8 0.6
syringe
3 Micro- 24 0.48 90.2 85.9 105 0.5
syringe
4 Micro- 24 0.85 104.6 107.4 97.4 0.8
syringe
5 Micro- 24 5.95 155.4 150.3 103.4 3.8
syringe
6 Micro- 24 3.7 201.9 198.2 101.9 1.8
syringe
7 Micro- 24 3.47 261.6 250.5 104.4 1.3
syringe
8 Micro- 24 6.07 374.5 375.1 99.8 1.6
syringe
9 Micro- 24 7.59 642.1 651.3 98.6 1.2
syringe
* WRSD = within-run standard deviation

Method Comparison with Human Whole Blood Samples


For testing syringe and capillary modes, blood was collected in heparinized
vacuum tubes. It was tonometered at 37°C and/or adjusted chemically. Several
levels of tHb were prepared by separating the red cells from the plasma and
recombining appropriately. Specimens were assayed on Rapidlab 1240 and
Rapidlab 865 systems.

02087462 Rev.V
E-18 Rapidlab 1200 Operator’s Guide: System Specifications

Method comparison was quantified by obtaining estimates of proportional (slope), and


constant (intercept) bias, root mean square error (RMSE), and method correlation (R
square for r2 coefficient of determination) by performing an ordinary least squares
analysis of the Rapidlab 1240 (dependent variable) versus the Rapidlab 865 (independent
variable). Results are summarized in the table below.
Table E-14 Rapidlab 1240 Human Whole Blood Method Comparison—pH

Mode n Slope Intercept RMSE r2 Min Max


Capillary 140 0.989 0.078 0.007 0.999 7.031 7.680
Syringe 286 1.007 -0.050 0.008 0.999 7.020 7.676
Micro- 144 0.984 0.133 0.013 0.995 7.038 7.671
capillary
Micro- 144 1.021 -0.155 0.007 0.999 7.013 7.651
syringe
pH Only 135 1.010 -0.064 0.010 0.998 7.015 7.678
Capillary
pH Only 271 1.011 -0.087 0.007 0.999 6.987 7.676
Syringe
Table E-15 Rapidlab 1240 Human Whole Blood Method Comparison—pCO2

Mode n Slope Intercept RMSE r2 Min Max


Capillary 216 0.942 2.097 7.661 0.985 5.7 257.3
Syringe 425 0.971 1.436 7.058 0.988 5.8 256.7
Micro- 108 1.038 -2.566 5.829 0.993 6.1 256.5
capillary
Micro- 216 1.075 -3.538 6.520 0.992 6.0 266.9
syringe

Rapidlab 1245 System Performance Characteristics


All performance data presented in this section was generated using the Rapidlab 1245
system. The system performed calibrations using the default settings recommended by
Siemens for optimum performance. All reported values were corrected to 760 mmHg. All
data was collected at room temperature (about 23°C). You should determine your own
performance characteristics in your laboratory with your Rapidlab 1245 system.

Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC) were
analyzed on the Rapidlab 1245 system. Manual QC is performed by the operator while
AutomaticQC is performed automatically by the system based on the QC frequency
defined in the system software. The results are presented here.

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-19

Precision on manual aqueous quality control materials was estimated using a


minimum of 3 Rapidlab 1245 systems. Controls were measured over a minimum
of 10 days.
Precision on the aqueous quality control materials in the AutomaticQC module
was estimated using a minimum of 3 Rapidlab 1245 systems over a minimum of
10 days. AutomaticQC is automatically scheduled to run (single sample)
independently 3 times per day.
The following tables summarize the results of the Rapidlab 1245 system precision
for manual QC and AutomaticQC:
Table E-16 Rapidlab 1245 Manual QC Precision Results

Parameter Level n Mean WRSD* Total SD†


pH 1 161 7.119 0.001 0.002
pH 2 161 7.328 0.001 0.002
pH 3 160 7.529 0.001 0.003
pCO2 1 161 72.6 0.42 1.14
pCO2 2 162 40.7 0.29 0.56
pCO2 3 160 22.9 0.21 0.36
pO2 1 161 147.3 0.69 1.85
pO2 2 162 97.7 0.85 1.56
pO2 3 160 24.8 0.73 1.07
tHb 1 132 17.8 0.05 0.14
tHb 2 132 14.2 0.05 0.11
tHb 3 132 7.8 0.03 0.06
FO2Hb 1 132 80.0 0.15 0.21
FO2Hb 2 132 93.3 0.14 0.29
FO2Hb 3 132 60.1 0.22 0.32
FCOHb 1 132 1.0 0.14 0.19
FCOHb 2 132 1.8 0.11 0.22
FCOHb 3 132 16.4 0.18 0.26
FMetHb 1 132 15.9 0.11 0.15
FMetHb 2 132 2.0 0.10 0.21
FMetHb 3 132 7.1 0.18 0.41
FHHb 1 132 3.2 0.05 0.08
FHHb 2 132 2.9 0.05 0.11
FHHb 3 132 16.4 0.08 0.14
* WRSD = within-run standard deviation

02087462 Rev.V
E-20 Rapidlab 1200 Operator’s Guide: System Specifications

† Total SD = total standard deviation

Table E-17 Rapidlab 1245 AutomaticQC Precision Results

Parameter Level n Mean WRSD* Total SD†


pH 1 170 7.15 0.002 0.002
pH 2 172 7.352 0.001 0.002
pH 3 168 7.553 0.002 0.003
pCO2 1 169 68.8 1.18 1.38
pCO2 2 172 39.1 0.59 0.95
pCO2 3 167 21.7 0.53 0.55
pO2 1 170 153.2 0.84 0.87
pO2 2 172 102.5 0.76 1.02
pO2 3 168 67.3 1.40 1.54
tHb 1 171 18.0 0.26 0.27
tHb 2 162 14.0 0.08 0.10
tHb 3 170 8.0 0.08 0.08
FO2Hb 1 171 78.3 2.44 2.52
FO2Hb 2 162 92.0 0.36 0.39
FO2Hb 3 170 60.2 0.31 0.31
FCOHb 1 171 3.2 2.18 2.27
FCOHb 2 162 3.7 0.38 0.38
FCOHb 3 170 18.2 0.23 0.27
FMetHb 1 171 15.9 0.59 0.60
FMetHb 2 162 1.8 0.25 0.25
FMetHb 3 170 5.8 0.44 0.45
FHHb 1 171 2.6 0.32 0.37
FHHb 2 162 2.4 0.17 0.20
FHHb 3 170 15.8 0.11 0.15
* WRSD = within-run standard deviation
† Total SD = total standard deviation

Recovery and Precision of Blood Gases in Human Whole Blood


To prepare samples for analysis, blood was collected in heparinized vacuum tubes and
tonometered at 37ºC for each of 6 levels for pH and 9 levels for pCO2/pO2. Multiple runs
were performed using these samples on a minimum of 3 Rapidlab 1245 systems.

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-21

The following tables summarize the results of the Rapidlab 1245 system human
whole blood recovery precision testing.
Table E-18 Rapidlab 1245 Recovery and Precision Testing—pH

Level Mode n WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.004 7.032 7.032 100.00 0.06
2 Capillary 24 0.003 7.205 7.202 100.04 0.04
3 Capillary 21 0.004 7.347 7.354 99.90 0.06
4 Capillary 24 0.003 7.409 7.410 99.99 0.04
5 Capillary 21 0.002 7.513 7.534 99.72 0.03
6 Capillary 24 0.002 7.664 7.630 100.45 0.02
1 Syringe 48 0.006 7.037 7.032 100.07 0.09
2 Syringe 48 0.005 7.213 7.202 100.15 0.07
3 Syringe 48 0.004 7.347 7.354 99.92 0.05
4 Syringe 48 0.003 7.422 7.410 100.16 0.03
5 Syringe 48 0.002 7.546 7.534 100.15 0.03
6 Syringe 48 0.002 7.626 7.630 99.95 0.03
1 Micro- 24 0.011 7.046 7.032 100.20 0.16
capillary
2 Micro- 24 0.011 7.197 7.202 99.92 0.15
capillary
3 Micro- 24 0.006 7.366 7.354 100.17 0.08
capillary
4 Micro- 24 0.009 7.413 7.410 100.03 0.13
capillary
5 Micro- 24 0.008 7.540 7.534 100.08 0.10
capillary
6 Micro- 24 0.021 7.624 7.630 99.92 0.27
capillary
1 Micro- 24 0.007 7.033 7.032 100.01 0.11
syringe
2 Micro- 24 0.004 7.193 7.202 99.86 0.06
syringe
3 Micro- 24 0.003 7.355 7.354 100.01 0.05
syringe
4 Micro- 24 0.003 7.413 7.410 100.03 0.04
syringe
5 Micro- 24 0.004 7.548 7.534 100.18 0.05
syringe
6 Micro- 24 0.003 7.619 7.630 99.85 0.05
syringe

02087462 Rev.V
E-22 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-18 Rapidlab 1245 Recovery and Precision Testing—pH

Level Mode n WRSD* Observed Expected Recovery WRCV


1 pH Only 24 0.007 7.024 7.032 99.88 0.10
Capillary
2 pH Only 24 0.004 7.198 7.202 99.94 0.05
Capillary
3 pH Only 24 0.008 7.362 7.354 100.11 0.10
Capillary
4 pH Only 24 0.003 7.414 7.410 100.05 0.04
Capillary
5 pH Only 24 0.005 7.542 7.534 100.11 0.07
Capillary
6 pH Only 24 0.004 7.653 7.630 100.30 0.05
Capillary
1 pH Only 48 0.004 7.016 7.032 99.77 0.06
Syringe
2 pH Only 48 0.003 7.189 7.202 99.82 0.05
Syringe
3 pH Only 48 0.002 7.350 7.354 99.95 0.03
Syringe
4 pH Only 48 0.003 7.389 7.410 99.72 0.04
Syringe
5 pH Only 48 0.002 7.517 7.534 99.78 0.03
Syringe
6 pH Only 48 0.003 7.631 7.630 100.01 0.04
Syringe
* WRSD = within-run standard deviation

Table E-19 Rapidlab 1245 Recovery and Precision Testing—pCO2

Level Mode n WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.16 7.5 7.1 104.7 2.1
2 Capillary 24 0.29 22.4 21.4 104.5 1.3
3 Capillary 24 0.56 27.3 28.6 95.4 2.1
4 Capillary 24 0.63 35.3 35.6 99.2 1.8
5 Capillary 24 0.94 49.6 50.0 99.2 1.9
6 Capillary 24 1.39 69.5 71.4 97.4 2.0
7 Capillary 23 3.58 95.4 99.7 95.6 3.8
8 Capillary 24 2.98 133.3 135.7 98.3 2.2
9 Capillary 24 3.27 215.7 228.0 94.6 1.5
1 Syringe 48 0.22 7.4 7.2 104.0 3.0

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-23

Table E-19 Rapidlab 1245 Recovery and Precision Testing—pCO2

Level Mode n WRSD* Observed Expected Recovery WRCV


2 Syringe 48 0.32 22.3 21.5 104.0 1.4
3 Syringe 48 0.47 27.4 28.6 95.6 1.7
4 Syringe 48 1.26 35.5 35.4 100.2 3.6
5 Syringe 48 1.47 50.9 50.1 101.6 2.9
6 Syringe 48 1.60 69.4 71.5 97.0 2.3
7 Syringe 48 3.69 98.7 99.1 99.7 3.7
8 Syringe 48 7.85 130.3 135.9 95.9 6.0
9 Syringe 45 4.22 220.7 226.4 97.5 1.9
1 Micro- 12 0.30 7.4 7.1 103.5 4.1
capillary
2 Micro- 12 0.37 22.8 21.4 106.4 1.6
capillary
3 Micro- 12 0.58 27.2 28.5 95.3 2.1
capillary
4 Micro- 12 0.52 36.7 35.7 103.0 1.4
capillary
5 Micro- 12 1.25 52.3 49.9 104.6 2.4
capillary
6 Micro- 12 2.41 69.3 71.3 97.2 3.5
capillary
7 Micro- 12 2.35 102.9 99.9 103.0 2.3
capillary
8 Micro- 12 3.29 135.8 135.6 100.1 2.4
capillary
9 Micro- 12 6.71 222.4 228.3 97.4 3.0
capillary
1 Micro- 24 0.26 7.2 7.2 101.2 3.6
syringe
2 Micro- 24 0.41 21.1 21.2 99.2 2.0
syringe
3 Micro- 24 0.62 25.6 28.3 90.5 2.4
syringe
4 Micro- 24 0.63 34.5 35.8 96.5 1.8
syringe
5 Micro- 24 0.92 49.1 50.1 97.9 1.9
syringe
6 Micro- 24 1.88 64.6 70.8 91.2 2.9
syringe

02087462 Rev.V
E-24 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-19 Rapidlab 1245 Recovery and Precision Testing—pCO2

Level Mode n WRSD* Observed Expected Recovery WRCV


7 Micro- 24 1.80 98.0 100.2 97.8 1.8
syringe
8 Micro- 24 2.55 127.8 136.0 94.0 2.0
syringe
9 Micro- 24 5.59 224.7 229.0 98.1 2.5
syringe
* WRSD = within-run standard deviation

Table E-20 Rapidlab 1245 Recovery and Precision Testing—pO2

Level Mode n WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.26 28.8 28.6 100.9 0.9
2 Capillary 24 0.37 51.7 50.0 103.5 0.7
3 Capillary 24 1.55 88.9 85.5 104.0 1.7
4 Capillary 24 1.32 103.5 107.1 96.7 1.3
5 Capillary 23 1.33 152.2 149.6 101.8 0.9
6 Capillary 24 2.49 199.0 199.9 99.5 1.2
7 Capillary 24 10.54 259.4 249.4 104.0 4.1
8 Capillary 24 3.90 378.5 378.4 100.0 1.0
9 Capillary 24 4.60 656.6 649.7 101.1 0.7
1 Syringe 48 0.29 27.6 28.6 96.5 1.0
2 Syringe 48 0.39 51.5 50.1 102.9 0.8
3 Syringe 48 0.88 87.1 84.9 102.5 1.0
4 Syringe 48 0.94 104.8 107.3 97.7 0.9
5 Syringe 48 0.97 153.0 148.6 103.0 0.6
6 Syringe 48 2.79 200.1 200.3 99.9 1.4
7 Syringe 45 3.07 258.0 247.6 104.2 1.2
8 Syringe 48 4.53 382.1 379.2 100.8 1.2
9 Syringe 48 5.67 657.9 651.1 101.0 0.9
1 Micro- 12 0.58 28.0 28.5 98.3 2.1
capillary
2 Micro- 12 0.81 51.3 49.9 102.7 1.6
capillary
3 Micro- 12 1.10 95.6 85.6 111.7 1.2
capillary
4 Micro- 12 0.67 106.0 107.0 99.0 0.6
capillary

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-25

Table E-20 Rapidlab 1245 Recovery and Precision Testing—pO2

Level Mode n WRSD* Observed Expected Recovery WRCV


5 Micro- 12 1.86 150.3 149.8 100.3 1.2
capillary
6 Micro- 12 2.21 186.7 199.5 93.6 1.2
capillary
7 Micro- 12 3.70 239.9 249.7 96.1 1.5
capillary
8 Micro- 12 9.31 332.2 377.6 88.0 2.8
capillary
9 Micro- 12 10.50 556.7 649.3 85.7 1.9
capillary
1 Micro- 24 0.33 27.5 28.3 97.0 1.2
syringe
2 Micro- 24 0.59 51.7 50.1 103.3 1.1
syringe
3 Micro- 24 0.79 91.3 85.9 106.3 0.9
syringe
4 Micro- 24 0.74 106.0 107.4 98.7 0.7
syringe
5 Micro- 24 1.06 150.6 150.3 100.2 0.7
syringe
6 Micro- 24 13.25 190.7 198.2 96.3 6.9
syringe
7 Micro- 24 3.57 247.5 250.5 98.8 1.4
syringe
8 Micro- 24 6.96 341.4 375.1 91.0 2.0
syringe
9 Micro- 24 8.38 583.6 651.3 89.6 1.4
syringe
* WRSD = within-run standard deviation

Recovery and Precision of Hemoglobin Fractions in Human


Whole Blood
For testing capillary, tHb, and syringe modes, blood is collected in heparinized
vacuum tubes. It is tonometered at 37°C and/or adjusted chemically. Three target
levels of tHb were prepared by separating the red cells from the plasma and
recombining appropriately. For each run, separated by mode, 3 replicates of each
level were run on a minimum of 3 Rapidlab 1245 systems. The mean bias was
determined by taking the difference between the Rapidlab 1245 system mean and
the reference methods mean. The mean bias and the pooled within run standard
deviation were determined for each blood preparation and sampling mode.

02087462 Rev.V
E-26 Rapidlab 1200 Operator’s Guide: System Specifications

The following tables summarize the results of the Rapidlab 1245 CO-ox module recovery
and precision testing.
Table E-21 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~6 g/dL and Oxyhemoglobin > 75%

Mean Mean Pooled


Analyte Mode* n Reference Bias RSD†
tHb Capillary 60 6.18 0.30 0.09
tHb tHb 54 6.18 0.19 0.13
tHb Syringe 53 6.14 0.25 0.05
FO2Hb Capillary 60 87.99 -1.37 0.26
FO2Hb tHb 55 87.34 -0.80 0.22
FO2Hb Syringe 54 88.15 -0.85 0.22
FCOHb Capillary 60 5.17 0.50 0.20
FCOHb tHb 55 4.86 0.63 0.19
FCOHb Syringe 54 5.34 0.70 0.25
FMetHb Capillary 60 4.99 0.22 0.10
FMetHb tHb 55 5.50 -0.05 0.11
FMetHb Syringe 54 5.84 -0.03 0.10
FHHb tHb 55 2.30 0.02 0.13
FHHb Capillary 60 1.86 0.16 0.19
FHHb Syringe 54 0.67 -0.06 0.12
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation

Table E-22 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%

Mean Mean Pooled


Analyte Mode* n Reference Bias RSD†
tHb Capillary 60 14.12 0.38 0.10
tHb tHb 58 14.17 0.05 0.20
tHb Syringe 51 14.07 0.29 0.09
FO2Hb Capillary 60 87.32 -0.65 0.17
FO2Hb tHb 58 86.86 -0.20 0.24
FO2Hb Syringe 53 87.73 0.05 0.17
FCOHb Capillary 60 5.45 0.04 0.13
FCOHb tHb 58 5.09 0.24 0.22
FCOHb Syringe 53 5.19 0.41 0.14

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-27

Table E-22 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%

Mean Mean Pooled


*
Analyte Mode n Reference Bias RSD†
FMetHb Capillary 60 5.22 -0.02 0.06
FMetHb tHb 58 5.22 -0.13 0.08
FMetHb Syringe 53 6.27 -0.41 0.06
FHHb tHb 58 2.83 -0.09 0.19
FHHb Capillary 60 2.01 0.16 0.12
FHHb Syringe 52 0.82 -0.29 0.11
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation

Table E-23 Rapidlab 1245 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~20 g/dL and Oxyhemoglobin > 75%

Mean Mean Pooled


*
Analyte Mode n Reference Bias RSD†
tHb Capillary 59 20.14 0.05 0.16
tHb tHb 52 20.10 -0.07 0.22
tHb Syringe 52 20.23 -0.08 0.15
FO2Hb Capillary 61 86.04 0.61 0.27
FO2Hb tHb 53 86.73 1.63 0.35
FO2Hb Syringe 53 87.01 1.41 0.21
FCOHb Capillary 60 5.45 0.04 0.13
FCOHb tHb 58 5.09 0.24 0.22
FCOHb Syringe 53 5.19 0.41 0.14
FMetHb Capillary 60 5.10 -0.19 0.09
FMetHb tHb 52 5.80 -0.36 0.12
FMetHb Syringe 53 6.23 -0.38 0.15
FHHb tHb 54 1.01 -0.70 0.08
FHHb Capillary 61 2.98 -0.18 0.10
FHHb Syringe 53 0.84 -0.45 0.08
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation

02087462 Rev.V
E-28 Rapidlab 1200 Operator’s Guide: System Specifications

Method Comparison with Human Whole Blood Samples


For testing syringe and capillary modes, blood was collected in heparinized vacuum tubes.
It was tonometered at 37°C or adjusted chemically. Several levels of tHb were prepared by
separating the red cells from the plasma and recombining appropriately. Specimens were
assayed on Rapidlab 1245 and Rapidlab 865 systems.
Method comparison was quantified by obtaining estimates of proportional (slope), and
constant (intercept) bias, root mean square error (RMSE), and method correlation (R
square for r2 coefficient of determination) by performing an ordinary least squares
analysis of the Rapidlab 1245 (dependent variable) versus the Rapidlab 865 (independent
variable). Results are summarized in the table below.
Table E-24 Rapidlab 1245 System Human Whole Blood Method Comparison—pH

Mode N Slope Intercept RMSE r2 Min Max


Capillary 135 1.002 -0.013 0.006 0.999 7.0 7.7
Syringe 288 1.008 -0.059 0.007 0.999 7.0 7.7
Micro- 144 0.988 0.089 0.015 0.994 7.0 7.7
capillary
Micro- 144 1.003 -0.029 0.007 0.999 7.0 7.6
syringe
pH Only 144 1.018 -0.123 0.009 0.998 7.0 7.7
Capillary
pH Only 288 1.014 -0.096 0.007 0.999 7.0 7.7
Syringe
Table E-25 Rapidlab 1245 System Human Whole Blood Method Comparison—
pCO2

Mode N Slope Intercept RMSE r2 Min Max


Capillary 215 0.961 1.609 5.348 0.993 6.7 231.4
Syringe 429 0.962 1.618 5.087 0.994 6.7 241.8
Micro- 108 1.004 1.044 3.225 0.998 6.9 237.3
capillary
Micro- 216 0.991 -1.479 4.363 0.996 6.7 242.0
syringe
Table E-26 Rapidlab 1245 System Human Whole Blood Method Comparison—pO2

Mode N Slope Intercept RMSE r2 Min Max


Capillary 215 0.974 4.195 12.240 0.996 27.6 677.3
Syringe 429 0.984 2.932 11.912 0.996 25.4 687.4
Micro- 84 0.922 8.530 5.706 0.993 26.7 254.3
capillary

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-29

Table E-26 Rapidlab 1245 System Human Whole Blood Method Comparison—pO2

Mode N Slope Intercept RMSE r2 Min Max


Micro- 168 0.941 5.553 7.223 0.990 26.2 259.5
syringe
Table E-27 Rapidlab 1245 System Human Whole Blood Method
Comparison—tHb

Mode N Slope Intercept RMSE r2


tHb 296 0.963 0.542 0.513 0.991
Capillary 330 0.957 0.849 0.478 0.993
Syringe 296 0.960 0.671 0.471 0.993
Table E-28 Rapidlab 1245 System Human Whole Blood Method
Comparison—FO2Hb

Mode N Slope Intercept RMSE r2


tHb 274 0.998 -0.123 2.292 0.994
Capillary 289 1.005 -0.892 1.701 0.997
Syringe 277 0.991 0.657 1.906 0.996
Table E-29 Rapidlab 1245 System Human Whole Blood Method
Comparison—FCOHb

Mode N Slope Intercept RMSE r2


tHb 188 0.979 0.013 1.119 0.998
Capillary 209 0.996 -0.128 0.959 0.999
Syringe 211 0.988 0.174 0.972 0.999
Table E-30 Rapidlab 1245 System Human Whole Blood Method
Comparison—FMetHb

Mode N Slope Intercept RMSE r2


tHb 202 0.990 0.055 1.055 0.999
Capillary 206 1.017 0.077 0.991 0.999
Syringe 210 0.970 0.054 0.951 0.999
Table E-31 Rapidlab 1245 System Human Whole Blood Method
Comparison—FHHb

Mode N Slope Intercept RMSE r2


tHb 139 1.005 0.676 1.797 0.998
Capillary 146 0.994 0.808 1.634 0.998
Syringe 117 0.989 0.348 1.657 0.998

02087462 Rev.V
E-30 Rapidlab 1200 Operator’s Guide: System Specifications

Rapidlab 1260 System Performance Characteristics


All performance data presented in this section was generated using the Rapidlab 1260
system. The system performed calibrations using the default settings recommended by
Siemens for optimum performance. All reported values were corrected to 760 mmHg. All
data was collected at room temperature (about 23°C). You should determine your own
performance characteristics in your laboratory with your Rapidlab 1260 system.

Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC) were
analyzed on the Rapidlab 1260 system. Manual QC is performed by the operator while
AutomaticQC is performed automatically by the system based on the QC frequency
defined in the system software. The results are presented here.

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-31

Precision on manual aqueous quality control materials was estimated using a


minimum of 3 Rapidlab 1260 systems. Controls were measured over a minimum
of 10 days.
Precision on the aqueous quality control materials in the AutomaticQC module
was estimated using a minimum of 3 Rapidlab 1260 systems over a minimum of
10 days. AutomaticQC is automatically scheduled to run (single sample)
independently 3 times per day.
The following tables summarize the results of the Rapidlab 1260 system precision
for manual QC and AutomaticQC.
Table E-32 Rapidlab 1260 Manual QC Precision Results

Parameter Level n Mean WRSD* Total SD†


Ca++ 1 154 1.68 0.007 0.011

Ca++ 2 155 1.31 0.004 0.008

Ca++ 3 152 0.83 0.006 0.008

Cl- 1 152 78 0.42 0.67

Cl- 2 153 98 0.34 0.74

Cl- 3 150 117 0.44 1.15


Glu 1 156 195 1.33 3.01
Glu 2 157 95 0.92 1.51
Glu 3 154 50 0.54 1.02
K+ 1 156 3.24 0.005 0.013

K+ 2 157 5.34 0.011 0.027

K+ 3 154 7.24 0.012 0.042


Lac 1 114 11.1 0.13 0.97
Lac 2 116 1.0 0.05 0.05
Lac 3 114 3.0 0.05 0.22
Na+ 1 156 119.2 0.15 0.31

Na+ 2 157 143.8 0.21 0.42

Na+ 3 154 168.7 0.24 0.49


pCO2 1 156 71.2 0.29 0.91
pCO2 2 157 40.3 0.32 0.45
pCO2 3 154 22.9 0.17 0.33
pH 1 155 7.118 0.001 0.003
pH 2 155 7.327 0.001 0.003
pH 3 153 7.527 0.001 0.003

02087462 Rev.V
E-32 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-32 Rapidlab 1260 Manual QC Precision Results

Parameter Level n Mean WRSD* Total SD†


pO2 1 144 148.9 0.79 2.81
pO2 2 145 97.9 0.89 1.74
pO2 3 142 23.7 1.22 1.85
* WRSD = within-run standard deviation
† Total SD = total standard deviation

Table E-33 Rapidlab 1260 AutomaticQC Precision Results

Analyte Level N Mean WRSD* Total SD†


Ca++ 1 234 1.62 0.006 0.006

Ca++ 2 234 1.22 0.004 0.004

Ca++ 3 234 0.80 0.004 0.005

Cl- 1 235 80 0.49 0.50


Cl- 2 235 100 0.61 0.63
Cl- 3 235 120 0.84 0.85
Glu 1 235 202 1.29 1.61
Glu 2 235 101 0.73 1.38
Glu 3 235 51 0.61 0.94
K+ 1 235 2.98 0.009 0.009

K+ 2 235 4.99 0.013 0.013

K+ 3 235 7.02 0.023 0.025


Lac 1 189 11.7 0.16 0.45
Lac 2 189 1.0 0.03 0.03
Lac 3 189 3.1 0.06 0.11
Na+ 1 235 114.9 0.31 0.31

Na+ 2 235 134.6 0.31 0.31

Na+ 3 235 155.0 0.37 0.38


pCO2 1 235 68.6 0.46 0.56
pCO2 2 235 39.5 0.36 0.49
pCO2 3 235 21.8 0.22 0.31
pH 1 234 7.15 0.001 0.002
pH 2 234 7.35 0.002 0.002
pH 3 234 7.551 0.002 0.003

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-33

Table E-33 Rapidlab 1260 AutomaticQC Precision Results

Analyte Level N Mean WRSD* Total SD†


pO2 1 213 154.1 0.86 1.34
pO2 2 213 103.3 1.19 1.27
pO2 3 213 67.3 1.80 2.14
* WRSD = within-run standard deviation
† Total SD = total standard deviation

Recovery and Precision in Human Whole Blood


To prepare samples for analysis, blood was collected in heparinized vacuum tubes
and tonometered at 37°C to each of 6 levels to prepare samples for pH, Na+, K+,
Cl-, and Ca++, 5 levels to prepare samples for glucose and lactate analysis, and 9
levels to prepare samples for pCO2 and pO2 analysis. Multiple runs were
performed using these samples on a minimum of 3 Rapidlab 1260 systems
The following tables summarize the results of the Rapidlab 1260 system human
whole blood recovery precision testing.
Table E-34 Rapidlab 1260 Recovery and Precision Testing—pH

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.003 7.056 7.048 100.11 0.04
2 Capillary 24 0.001 7.228 7.231 99.96 0.02
3 Capillary 24 0.005 7.317 7.311 100.09 0.07
4 Capillary 25 0.001 7.433 7.423 100.14 0.02
5 Capillary 24 0.002 7.539 7.526 100.17 0.02
6 Capillary 24 0.002 7.650 7.637 100.16 0.03
1 Syringe 46 0.008 7.038 7.048 99.87 0.11
2 Syringe 48 0.003 7.232 7.231 100.02 0.05
3 Syringe 48 0.005 7.310 7.311 99.99 0.07
4 Syringe 46 0.003 7.424 7.423 100.02 0.04
5 Syringe 51 0.002 7.525 7.526 99.98 0.03
6 Syringe 45 0.003 7.633 7.637 99.95 0.03
1 Micro- 12 0.002 7.040 7.048 99.88 0.03
capillary
2 Micro- 12 0.002 7.138 7.175 99.48 0.02
capillary
3 Micro- 12 0.003 7.343 7.338 100.06 0.04
capillary
4 Micro- 12 0.001 7.430 7.420 100.13 0.01
capillary

02087462 Rev.V
E-34 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-34 Rapidlab 1260 Recovery and Precision Testing—pH

Level Mode N WRSD* Observed Expected Recovery WRCV


5 Micro- 12 0.003 7.532 7.541 99.87 0.05
capillary
6 Micro- 12 0.002 7.645 7.635 100.13 0.02
capillary
1 Micro- 24 0.011 7.062 7.048 100.20 0.15
syringe
2 Micro- 23 0.003 7.205 7.175 100.42 0.05
syringe
3 Micro- 24 0.006 7.335 7.338 99.95 0.08
syringe
4 Micro- 24 0.001 7.413 7.420 99.90 0.02
syringe
5 Micro- 21 0.005 7.544 7.541 100.04 0.07
syringe
6 Micro- 24 0.003 7.630 7.635 99.93 0.04
syringe
1 pH Only 24 0.004 7.028 7.045 99.75 0.05
Cap
2 pH Only 24 0.002 7.218 7.227 99.87 0.03
Cap
3 pH Only 24 0.006 7.341 7.329 100.16 0.08
Cap
4 pH Only 23 0.002 7.412 7.419 99.90 0.02
Cap
5 pH Only 24 0.002 7.515 7.529 99.81 0.02
Cap
6 pH Only 24 0.003 7.616 7.608 100.11 0.03
Cap
1 pH Only 46 0.005 7.047 7.045 100.02 0.07
Syr
2 pH Only 45 0.005 7.233 7.227 100.09 0.07
Syr
3 pH Only 47 0.002 7.315 7.329 99.81 0.03
Syr
4 pH Only 45 0.003 7.419 7.419 100.00 0.04
Syr
5 pH Only 45 0.002 7.537 7.529 100.10 0.02
Syr
6 pH Only 44 0.002 7.600 7.608 99.90 0.03
Syr

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-35

Table E-34 Rapidlab 1260 Recovery and Precision Testing—pH

Level Mode N WRSD* Observed Expected Recovery WRCV


1 pH, Glu, 24 0.008 7.064 7.063 100.01 0.12
Lac
Capillary
2 pH, Glu, 24 0.005 7.235 7.228 100.09 0.06
Lac
Capillary
3 pH, Glu, 24 0.004 7.325 7.321 100.05 0.05
Lac
Capillary
4 pH, Glu, 24 0.002 7.431 7.427 100.06 0.03
Lac
Capillary
5 pH, Glu, 24 0.002 7.560 7.551 100.12 0.03
Lac
Capillary
6 pH, Glu, 24 0.004 7.648 7.649 99.98 0.05
Lac
Capillary
1 pH, Glu, 37 0.005 7.068 7.072 99.95 0.07
Lac
Syringe
2 pH, Glu, 48 0.004 7.237 7.234 100.03 0.06
Lac
Syringe
3 pH, Glu, 37 0.005 7.303 7.309 99.91 0.07
Lac
Syringe
4 pH, Glu, 47 0.002 7.438 7.439 99.99 0.02
Lac
Syringe
5 pH, Glu, 36 0.002 7.563 7.561 100.02 0.03
Lac
Syringe
6 pH, Glu, 48 0.002 7.651 7.650 100.01 0.02
Lac
Syringe
* WRSD = within-run standard deviation

Table E-35 Rapidlab 1260 Recovery and Precision Testing—pCO2

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 23 0.24 7.4 7.1 104.2 3.3

02087462 Rev.V
E-36 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-35 Rapidlab 1260 Recovery and Precision Testing—pCO2

Level Mode N WRSD* Observed Expected Recovery WRCV


2 Capillary 24 0.50 22.6 21.3 105.9 2.2
3 Capillary 24 0.34 29.0 28.4 101.9 1.2
4 Capillary 24 0.45 36.9 35.4 104.2 1.2
5 Capillary 24 0.83 48.3 49.9 96.8 1.7
6 Capillary 24 0.90 72.0 71.1 101.3 1.3
7 Capillary 24 1.16 99.3 99.1 100.2 1.2
8 Capillary 24 1.53 129.9 135.4 95.9 1.2
9 Capillary 24 3.41 216.3 226.4 95.6 1.6
1 Syringe 45 0.28 7.5 7.1 105.8 3.7
2 Syringe 48 0.35 21.6 21.4 100.6 1.6
3 Syringe 48 0.37 28.9 28.6 101.2 1.3
4 Syringe 48 0.81 36.6 35.5 103.1 2.2
5 Syringe 45 0.60 49.6 49.9 99.4 1.2
6 Syringe 48 0.86 72.7 71.4 101.7 1.2
7 Syringe 48 1.27 95.5 99.3 96.2 1.3
8 Syringe 45 2.16 130.6 135.4 96.5 1.7
9 Syringe 47 5.09 213.4 227.0 94.0 2.4
1 Micro- 12 0.25 6.9 7.1 96.9 3.7
capillary
2 Micro- 12 0.28 21.0 21.3 98.4 1.3
capillary
3 Micro- 12 0.28 27.9 28.4 98.2 1.0
capillary
4 Micro- 12 1.03 35.3 35.8 98.7 2.9
capillary
5 Micro- 12 0.62 48.5 49.8 97.4 1.3
capillary
6 Micro- 12 1.24 70.5 71.1 99.2 1.8
capillary
7 Micro- 12 1.66 100.2 100.2 100.0 1.7
capillary
8 Micro- 12 1.71 137.7 135.1 101.9 1.2
capillary
9 Micro- 12 4.66 230.2 229.1 100.5 2.0
capillary
1 Micro- 24 0.29 6.7 7.1 94.6 4.3
syringe

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-37

Table E-35 Rapidlab 1260 Recovery and Precision Testing—pCO2

Level Mode N WRSD* Observed Expected Recovery WRCV


2 Micro- 24 0.56 20.7 21.4 96.7 2.7
syringe
3 Micro- 24 0.50 28.2 28.6 98.6 1.8
syringe
4 Micro- 24 1.00 34.7 35.7 97.4 2.9
syringe
5 Micro- 24 1.31 48.2 49.5 97.4 2.7
syringe
6 Micro- 24 1.49 72.2 71.4 101.1 2.1
syringe
7 Micro- 24 2.67 97.1 99.8 97.3 2.8
syringe
8 Micro- 23 2.02 131.4 134.4 97.8 1.5
syringe
9 Micro- 24 4.15 229.7 228.2 100.7 1.8
syringe
* WRSD = within-run standard deviation

Table E-36 Rapidlab 1260 Recovery and Precision Testing—pO2

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.31 30.4 28.4 106.9 1.0
2 Capillary 21 0.36 49.6 49.9 99.5 0.7
3 Capillary 24 0.66 89.7 84.9 105.6 0.7
4 Capillary 21 0.51 105.2 106.8 98.5 0.5
5 Capillary 24 1.52 150.8 148.6 101.5 1.0
6 Capillary 21 0.60 204.7 198.9 102.9 0.3
7 Capillary 24 1.16 255.4 247.6 103.1 0.5
8 Capillary 21 1.74 379.5 376.5 100.8 0.5
9 Capillary 20 6.79 654.4 648.1 101.0 1.0
1 Syringe 45 0.52 29.8 28.6 104.3 1.8
2 Syringe 42 0.35 49.2 49.9 98.7 0.7
3 Syringe 48 0.75 87.6 85.1 102.9 0.9
4 Syringe 42 0.67 106.4 106.9 99.5 0.6
5 Syringe 48 2.18 148.5 148.9 99.7 1.5
6 Syringe 45 2.21 200.3 200.0 100.1 1.1
7 Syringe 47 11.16 256.6 248.3 103.3 4.3
8 Syringe 45 7.47 371.0 378.6 98.0 2.0

02087462 Rev.V
E-38 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-36 Rapidlab 1260 Recovery and Precision Testing—pO2

Level Mode N WRSD* Observed Expected Recovery WRCV


9 Syringe 42 13.76 652.3 648.5 100.6 2.1
1 Micro- 12 0.20 26.2 28.4 92.3 0.8
capillary
2 Micro- 12 0.57 46.6 49.8 93.5 1.2
capillary
3 Micro- 12 0.61 83.1 85.9 96.7 0.7
capillary
4 Micro- 12 0.89 105.0 106.7 98.5 0.9
capillary
5 Micro- 12 0.75 149.3 150.4 99.3 0.5
capillary
6 Micro- 12 5.00 201.5 198.9 101.3 2.5
capillary
7 Micro- 12 2.22 263.9 250.6 105.3 0.8
capillary
8 Micro- 12 3.91 380.4 376.6 101.0 1.0
capillary
9 Micro- 12 8.65 656.9 647.0 101.5 1.3
capillary
1 Micro- 24 0.26 26.5 28.6 92.8 1.0
syringe
2 Micro- 24 0.37 46.6 49.5 94.2 0.8
syringe
3 Micro- 24 0.73 81.3 85.6 95.1 0.9
syringe
4 Micro- 23 0.88 104.1 106.1 98.1 0.8
syringe
5 Micro- 24 1.33 147.8 149.7 98.7 0.9
syringe
6 Micro- 24 3.36 201.4 199.9 100.7 1.7
syringe
7 Micro- 24 2.75 267.9 249.6 107.4 1.0
syringe
8 Micro- 24 4.02 386.6 378.4 102.2 1.0
syringe
9 Micro- 24 12.58 670.7 643.4 104.2 1.9
syringe
* WRSD = within-run standard deviation

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-39

Table E-37 Rapidlab 1260 Recovery and Precision Testing—Na+

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.26 113.8 111.2 102.3 0.2
2 Capillary 24 0.21 130.6 129.4 100.9 0.2
3 Capillary 24 0.30 135.0 134.4 100.4 0.2
4 Capillary 24 0.55 142.8 141.5 100.9 0.4
5 Capillary 24 0.43 147.9 148.6 99.5 0.3
6 Capillary 24 0.85 175.7 179.8 97.7 0.5
1 Syringe 47 0.27 114.3 111.2 102.7 0.2
2 Syringe 48 0.29 129.7 129.4 100.2 0.2
3 Syringe 48 0.34 134.8 134.4 100.3 0.3
4 Syringe 48 0.71 141.2 141.5 99.8 0.5
5 Syringe 48 0.34 148.9 148.6 100.2 0.2
6 Syringe 48 0.78 174.6 179.8 97.1 0.4
1 Micro- 12 0.62 110.2 109.9 100.3 0.6
capillary
2 Micro- 12 0.18 129.5 130.1 99.6 0.1
capillary
3 Micro- 12 0.60 131.7 132.0 99.8 0.5
capillary
4 Micro- 12 1.11 143.1 143.8 99.5 0.8
capillary
5 Micro- 12 0.29 149.6 150.8 99.2 0.2
capillary
6 Micro- 12 1.29 175.4 178.1 98.5 0.7
capillary
1 Micro- 24 0.41 109.6 109.9 99.8 0.4
syringe
2 Micro- 24 0.15 130.6 130.1 100.4 0.1
syringe
3 Micro- 23 0.21 132.1 132.0 100.1 0.2
syringe
4 Micro- 24 0.62 143.5 143.8 99.8 0.4
syringe
5 Micro- 24 0.47 150.1 150.8 99.5 0.3
syringe
6 Micro- 22 0.99 178.7 178.1 100.3 0.6
syringe
* WRSD = within-run standard deviation

02087462 Rev.V
E-40 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-38 Rapidlab 1260 Recovery and Precision Testing—K+

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.096 1.21 1.18 102.2 8.0
2 Capillary 24 0.046 2.56 2.63 97.3 1.8
3 Capillary 24 0.034 4.19 4.12 101.7 0.8
4 Capillary 23 0.107 6.05 5.74 105.2 1.8
5 Capillary 21 0.084 7.88 7.99 98.6 1.1
6 Capillary 23 0.163 11.55 11.31 102.1 1.4
1 Syringe 45 0.078 1.19 1.18 100.5 6.5
2 Syringe 45 0.024 2.64 2.63 100.1 0.9
3 Syringe 45 0.026 4.12 4.12 100.1 0.6
4 Syringe 45 0.052 5.70 5.74 99.2 0.9
5 Syringe 45 0.116 8.18 7.99 102.3 1.4
6 Syringe 45 0.118 11.69 11.31 103.4 1.0
1 Micro- 12 0.078 1.45 1.15 126.1 5.3
capillary
2 Micro- 13 0.027 2.84 2.82 100.8 1.0
capillary
3 Micro- 12 0.024 3.72 3.77 98.4 0.7
capillary
4 Micro- 12 0.042 5.57 5.71 97.6 0.7
capillary
5 Micro- 11 0.073 7.58 8.05 94.1 1.0
capillary
6 Micro- 12 0.190 11.86 11.97 99.1 1.6
capillary
1 Micro- 22 0.088 1.29 1.15 112.5 6.8
syringe
2 Micro- 24 0.031 2.89 2.82 102.6 1.1
syringe
3 Micro- 24 0.019 3.73 3.77 98.7 0.5
syringe
4 Micro- 24 0.044 5.61 5.71 98.2 0.8
syringe
5 Micro- 20 0.159 7.97 8.05 99.0 2.0
syringe
6 Micro- 18 0.269 11.90 11.97 99.4 2.3
syringe
* WRSD = within-run standard deviation

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-41

Table E-39 1260 Recovery and Precision Testing—Cl-

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.58 72 73 99.2 0.8
2 Capillary 24 0.29 90 91 99.3 0.3
3 Capillary 24 0.58 97 98 98.8 0.6
4 Capillary 24 0.58 104 106 97.8 0.6
5 Capillary 24 0.50 110 111 99.1 0.5
6 Capillary 24 1.08 146 148 98.8 0.7
1 Syringe 47 0.57 70 71 98.2 0.8
2 Syringe 48 0.41 90 91 99.1 0.5
3 Syringe 48 0.79 98 99 99.0 0.8
4 Syringe 48 0.80 104 105 99.0 0.8
5 Syringe 48 0.56 110 110 99.3 0.5
6 Syringe 43 1.39 145 146 99.1 1.0
1 Micro- 12 0.81 81 80 100.7 1.0
capillary
2 Micro- 12 0.31 98 98 100.1 0.3
capillary
3 Micro- 12 0.61 99 100 99.3 0.6
capillary
4 Micro- 12 1.14 104 105 99.1 1.1
capillary
5 Micro- 12 0.53 115 116 99.2 0.5
capillary
6 Micro- 12 3.04 142 141 100.5 2.1
capillary
1 Micro- 24 0.48 81 81 100.6 0.6
syringe
2 Micro- 24 0.31 95 96 99.8 0.3
syringe
3 Micro- 23 0.22 98 99 98.8 0.2
syringe
4 Micro- 24 0.75 105 106 99.6 0.7
syringe
5 Micro- 24 0.84 116 116 100.2 0.7
syringe
6 Micro- 22 1.30 144 143 100.4 0.9
syringe
* WRSD = within-run standard deviation

02087462 Rev.V
E-42 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-40 Rapidlab 1260 Recovery and Precision Testing—Ca++

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.015 0.58 0.58 98.5 2.5
2 Capillary 24 0.015 1.27 1.26 100.6 1.2
3 Capillary 25 0.006 1.35 1.36 99.5 0.4
4 Capillary 24 0.017 1.90 1.93 98.8 0.9
5 Capillary 24 0.047 2.30 2.36 97.8 2.0
6 Capillary 24 0.089 4.06 4.09 99.2 2.2
1 Syringe 48 0.017 0.57 0.58 97.8 2.9
2 Syringe 48 0.012 1.26 1.26 100.4 1.0
3 Syringe 46 0.009 1.34 1.36 98.5 0.6
4 Syringe 51 0.027 1.87 1.93 97.2 1.4
5 Syringe 45 0.046 2.30 2.36 97.6 2.0
6 Syringe 45 0.099 4.22 4.09 103.1 2.4
1 Micro- 12 0.034 0.57 0.56 101.6 5.9
capillary
2 Micro- 12 0.018 1.24 1.24 100.0 1.4
capillary
3 Micro- 12 0.005 1.30 1.30 100.0 0.4
capillary
4 Micro- 12 0.024 1.96 1.98 99.0 1.2
capillary
5 Micro- 12 0.050 2.39 2.38 100.5 2.1
capillary
6 Micro- 12 0.055 3.89 3.98 97.8 1.4
capillary
1 Micro- 23 0.011 0.54 0.56 94.8 2.0
syringe
2 Micro- 24 0.015 1.23 1.24 99.4 1.2
syringe
3 Micro- 24 0.006 1.30 1.30 100.3 0.5
syringe
4 Micro- 22 0.074 1.99 1.98 100.4 3.7
syringe
5 Micro- 24 0.032 2.41 2.38 101.4 1.4
syringe
6 Micro- 24 0.092 4.02 3.98 101.0 2.3
syringe
* WRSD = within-run standard deviation

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-43

Table E-41 Rapidlab 1260 Recovery and Precision Testing—Glucose

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.76 50.2 46 109.1 1.5
2 Capillary 24 1.29 89 88 101.6 1.4
3 Capillary 24 3.93 216 211 102.4 1.8
4 Capillary 24 6.25 330 350 94.3 1.9
5 Capillary 24 5.75 454 466 97.4 1.3
1 Syringe 48 0.99 44 40 109.4 2.3
2 Syringe 48 1.83 86 82 105.2 2.1
3 Syringe 48 2.87 214 212 101.4 1.3
4 Syringe 48 3.52 338 357 94.6 1.0
5 Syringe 47 5.45 469 467 100.4 1.2
1 Micro- 12 1.32 46 44 103.6 2.9
capillary
2 Micro- 12 0.71 88 88 100.6 0.8
capillary
3 Micro- 12 1.55 221 219 100.6 0.7
capillary
4 Micro- 12 4.44 331 343 96.5 1.3
capillary
5 Micro- 12 7.98 448 452 99.1 1.8
capillary
1 Micro- 24 0.84 49 48 94.3 1.3
syringe
2 Micro- 24 2.10 99 98 100.3 1.0
syringe
3 Micro- 24 1.61 224 222 97.8 2.1
syringe
4 Micro- 22 4.72 350 371 93.5 1.3
syringe
5 Micro- 24 4.73 453 452 98.9 1.4
syringe
1 pH, Glu, 21 1.50 50 46 109.4 3.0
Lac
Capillary
2 pH, Glu, 24 1.07 96 93 104.1 1.1
Lac
Capillary
3 pH, Glu, 22 3.98 205 205 100.0 1.9
Lac
Capillary

02087462 Rev.V
E-44 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-41 Rapidlab 1260 Recovery and Precision Testing—Glucose

Level Mode N WRSD* Observed Expected Recovery WRCV


4 pH, Glu, 24 4.75 353 365 97.0 1.3
Lac
Capillary
5 pH, Glu, 23 14.82 500 525 95.2 3.0
Lac
Capillary
1 pH, Glu, 48 1.18 48 43 112.8 2.5
Lac
Syringe
2 pH, Glu, 48 2.01 93 87 107.0 2.2
Lac
Syringe
3 pH, Glu, 43 2.91 216 213 101.6 1.3
Lac
Syringe
4 pH, Glu, 48 4.93 377 382 98.6 1.3
Lac
Syringe
5 pH, Glu, 48 6.15 500 520 96.1 1.2
Lac
Syringe
* WRSD = within-run standard deviation

Table E-42 Rapidlab 1260 Recovery and Precision Testing—Lactate

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.09 1.5 1.5 97.5 6.2
2 Capillary 24 0.06 2.1 2.2 96.8 3.0
3 Capillary 21 0.08 4.7 5.1 91.4 1.7
4 Capillary 24 0.16 9.1 11.0 83.2 1.8
5 Capillary 21 0.17 11.7 14.2 82.4 1.5
1 Syringe 45 0.03 1.1 1.3 89.8 3.0
2 Syringe 48 0.05 2.1 2.2 94.6 2.4
3 Syringe 45 0.15 5.1 5.6 90.5 3.1
4 Syringe 48 0.20 9.3 10.9 85.4 2.2
5 Syringe 45 0.21 12.1 14.3 84.3 1.7
1 Micro- 12 0.09 1.1 1.0 104.4 8.1
capillary
2 Micro- 9 0.09 4.3 4.4 98.4 2.2
capillary

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-45

Table E-42 Rapidlab 1260 Recovery and Precision Testing—Lactate

Level Mode N WRSD* Observed Expected Recovery WRCV


3 Micro- 12 0.08 5.7 6.7 85.6 1.3
capillary
4 Micro- 9 0.14 9.9 11.8 83.3 1.4
capillary
5 Micro- 12 0.52 13.1 16.2 80.7 4.0
capillary
1 Micro- 24 0.08 1.2 1.2 101.0 6.2
syringe
2 Micro- 24 0.08 3.2 3.6 86.9 2.6
syringe
3 Micro- 23 0.17 5.8 6.4 91.8 2.9
syringe
4 Micro- 23 0.36 9.3 10.9 85.7 3.8
syringe
5 Micro- 24 0.15 11.7 13.9 84.1 1.3
syringe
1 pH, Glu, 24 0.05 0.9 0.9 109.1 5.4
Lac
Capillary
2 pH, Glu, 24 0.04 2.8 2.8 99.0 1.6
Lac
Capillary
3 pH, Glu, 24 0.12 4.9 5.2 93.8 2.4
Lac
Capillary
4 pH, Glu, 24 0.20 11.2 12.3 91.4 1.7
Lac
Capillary
5 pH, Glu, 24 0.41 14.9 17.6 84.8 2.7
Lac
Capillary
1 pH, Glu, 45 0.02 0.9 0.8 105.0 2.4
Lac
Syringe
2 pH, Glu, 44 0.07 2.6 2.7 95.3 2.5
Lac
Syringe
3 pH, Glu, 48 0.09 5.7 6.0 94.5 1.6
Lac
Syringe

02087462 Rev.V
E-46 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-42 Rapidlab 1260 Recovery and Precision Testing—Lactate

Level Mode N WRSD* Observed Expected Recovery WRCV


4 pH, Glu, 46 0.15 11.3 12.6 89.8 1.3
Lac
Syringe
5 pH, Glu, 47 0.36 15.6 18.0 86.6 2.3
Lac
Syringe
* WRSD = within-run standard deviation

Method Comparison with Human Whole Blood Samples


For testing syringe and capillary modes, blood was collected in heparinized vacuum tubes.
It was tonometered at 37°C and/or adjusted chemically. Several levels of tHb were
prepared by separating the red cells from the plasma and recombining appropriately.
Specimens were assayed on Rapidlab 1260 and Rapidlab 865 systems.
Method comparison was quantified by obtaining estimates of proportional (slope), and
constant (intercept) bias, root mean square error (RMSE), and method correlation (R
square for r2 coefficient of determination) by performing an ordinary least squares
analysis of the Rapidlab 1260 (dependent variable) versus the Rapidlab 865 (independent
variable). Results are summarized in the table below.
Table E-43 Rapidlab 1260 Human Whole Blood Method Comparison—pH

Mode N Slope Intercept RMSE r2 Min Max


Capillary 145 1.001 -0.003 0.009 0.998 7.042 7.684
Syringe 284 1.015 -0.108 0.008 0.998 6.991 7.676
Micro- 72 0.989 0.080 0.006 0.999 7.030 7.651
capillary
Micro- 143 0.950 0.361 0.059 0.911 7.030 7.651
syringe
pH Only 143 1.001 -0.003 0.007 0.999 7.015 7.639
Capillary
pH Only 273 1.004 -0.035 0.009 0.998 7.004 7.642
Syringe
pH, Glu, 144 1.001 -0.000 0.007 0.999 7.046 7.657
Lac
Capillary
pH, Glu, 253 1.006 -0.045 0.006 0.999 7.045 7.660
Lac
Syringe

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-47

Table E-44 Rapidlab 1260 Human Whole Blood Method Comparison—pCO2

Mode N Slope Intercept RMSE r2 Min Max


Capillary 215 0.960 2.066 3.430 0.997 6.9 226.2
Syringe 422 0.922 3.229 5.437 0.992 6.9 229.0
Micro- 108 1.056 -2.100 2.851 0.998 6.5 238.7
capillary
Micro- 215 1.017 -1.734 2.905 0.998 5.8 242.4
syringe
Table E-45 Rapidlab 1260 Human Whole Blood Method Comparison—pO2

Mode N Slope Intercept RMSE r2 Min Max


Capillary 197 0.996 2.965 6.092 0.999 28.5 681.6
Syringe 404 0.982 2.718 10.291 0.997 26.0 723.9
Micro- 108 0.987 1.114 6.417 0.999 24.9 684.7
capillary
Micro- 215 1.013 -3.218 7.534 0.999 24.9 714.8
syringe

Table E-46 Rapidlab 1260 Human Whole Blood Method Comparison—Na+

Mode N Slope Intercept RMSE r2 Min Max


Capillary 144 0.964 5.366 1.596 0.994 107.8 186.1
Syringe 287 0.987 2.153 1.352 0.996 107.6 184.3
Micro- 72 0.942 8.008 1.366 0.995 110.5 178.7
capillary
Micro- 141 0.979 3.552 0.806 0.998 109.8 182.6
syringe

Table E-47 Rapidlab 1260 Human Whole Blood Method Comparison—K+

Mode N Slope Intercept RMSE r2 Min Max


Capillary 137 1.066 -0.139 0.202 0.997 0.81 12.90
Syringe 270 1.095 -0.272 0.215 0.997 0.72 13.08
Micro- 72 0.962 0.165 0.132 0.999 1.26 12.35
capillary
Micro- 136 0.971 0.122 0.347 0.990 0.93 13.19
syringe

02087462 Rev.V
E-48 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-48 Rapidlab 1260 Human Whole Blood Method Comparison—Ca++

Mode N Slope Intercept RMSE r2 Min Max


Capillary 145 1.085 -0.090 0.097 0.993 0.50 4.81
Syringe 283 1.101 -0.112 0.087 0.995 0.47 4.89
Micro- 72 0.987 0.015 0.053 0.998 0.50 4.29
capillary
Micro- 143 1.013 0.012 0.271 0.945 0.48 4.49
syringe

Table E-49 Rapidlab 1260 Human Whole Blood Method Comparison—Cl-

Mode N Slope Intercept RMSE r2 Min Max


Capillary 144 1.033 -2.930 1.655 0.995 69 152
Syringe 287 1.068 -6.834 2.083 0.992 64 154
Micro- 72 0.922 14.282 1.626 0.992 86 150
capillary
Micro- 141 0.915 14.724 1.615 0.992 85 153
syringe
Table E-50 Rapidlab 1260 Human Whole Blood Method Comparison—Glucose

Mode N Slope Intercept RMSE r2 Min Max


Capillary 120 0.881 8.096 17.253 0.987 43 528
Syringe 239 0.908 6.686 16.179 0.990 32 521
Micro- 60 0.936 3.403 6.436 0.998 43 488
capillary
Micro- 118 0.964 2.091 4.890 0.999 41 502
syringe
pH, Glu, 114 0.936 10.196 10.755 0.996 45 541
Lac
Capillary
pH, Glu, 235 0.948 10.865 9.758 0.997 38 530
Lac
Syringe
Table E-51 Rapidlab 1260 Human Whole Blood Method Comparison—Lactate

Mode N Slope Intercept RMSE r2 Min Max


Capillary 111 0.812 0.521 0.422 0.989 1.0 13.4
Syringe 231 0.826 0.286 0.558 0.983 0.8 14.1
Micro- 54 0.781 0.590 0.555 0.985 0.9 14.7
capillary
Micro- 118 0.777 0.517 0.541 0.983 0.9 14.3
syringe

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-49

Table E-51 Rapidlab 1260 Human Whole Blood Method Comparison—Lactate

Mode N Slope Intercept RMSE r2 Min Max


pH, Glu, 120 0.842 0.423 0.527 0.990 0.8 16.6
Lac
Capillary
pH, Glu, 230 0.857 0.326 0.545 0.990 0.7 17.8
Lac
Syringe

Rapidlab 1265 System Performance Characteristics


All performance data presented in this section was generated using the
Rapidlab 1265 system. The system performed calibrations using the default
settings recommended by Siemens for optimum performance. All reported values
were corrected to 760 mmHg. All data was collected at room temperature (about
23°C). You should determine your own performance characteristics in your
laboratory with your Rapidlab 1265 system.

Precision on Controls
Quality control materials, including manual (QC) and automatic (AutomaticQC)
were analyzed on the Rapidlab 1265 system. Manual QC is performed by the
operator while AutomaticQC is performed automatically by the system based on
the QC frequency defined in the system software. The results are presented here.
Precision on manual aqueous quality control materials was estimated using a
minimum of 3 Rapidlab 1265 systems. Controls were measured over a minimum
of 10 days.
Precision on the aqueous quality control materials in the AutomaticQC module
was estimated using a minimum of 3 Rapidlab 1265 systems over a minimum of
10 days. AutomaticQC is automatically scheduled to run (single sample)
independently 3 times per day. The following tables summarize the results of the
Rapidlab 1265 system precision for manual QC and AutomaticQC.
Table E-52 Rapidlab 1265 Manual QC Precision Results

Parameter Level n Mean WRSD* Total SD†


Ca++ 1 145 1.67 0.005 0.017

Ca++ 2 146 1.31 0.005 0.013

Ca++ 3 146 0.84 0.007 0.010

Cl- 1 147 78 0.38 0.49

Cl- 2 148 98 0.26 0.48

Cl- 3 148 118 0.44 0.63


Glu 1 147 197 1.27 2.02

02087462 Rev.V
E-50 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-52 Rapidlab 1265 Manual QC Precision Results

Parameter Level n Mean WRSD* Total SD†


Glu 2 148 96 0.67 1.50
Glu 3 148 50 0.71 1.68
K+ 1 147 3.25 0.005 0.013

K+ 2 148 5.33 0.012 0.024

K+ 3 148 7.22 0.013 0.039


Lac 1 103 11.2 0.11 0.57
Lac 2 104 1.0 0.04 0.04
Lac 3 104 3.1 0.05 0.13
Na+ 1 147 119.2 0.29 0.32

Na+ 2 148 143.8 0.27 0.53

Na+ 3 148 168.6 0.27 0.81


pCO2 1 147 72.3 0.26 0.82
pCO2 2 148 40.7 0.24 0.33
pCO2 3 148 22.9 0.15 0.30
pH 1 147 7.118 0.001 0.002
pH 2 148 7.327 0.001 0.003
pH 3 148 7.527 0.001 0.003
pO2 1 147 148.2 1.06 1.99
pO2 2 148 97.8 0.81 1.66
pO2 3 148 24.4 1.34 1.86
tHb 1 153 17.4 0.19 0.25
tHb 2 169 13.6 0.14 0.18
tHb 3 164 7.7 0.09 0.12
FO2Hb 1 153 79.0 0.49 0.79
FO2Hb 2 169 94.4 0.70 1.07
FO2Hb 3 164 60.1 0.78 1.07
FCOHb 1 153 2.0 0.60 0.92
FCOHb 2 169 1.3 0.73 0.98
FCOHb 3 164 16.5 0.52 0.66
FMetHb 1 153 16.1 0.17 0.23
FMetHb 2 169 1.2 0.21 0.37
FMetHb 3 164 7.0 0.52 0.66

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-51

Table E-52 Rapidlab 1265 Manual QC Precision Results

Parameter Level n Mean WRSD* Total SD†


FHHb 1 153 2.9 0.26 0.33
FHHb 2 169 3.0 0.33 0.37
FHHb 3 164 16.4 0.22 0.28
* WRSD = within-run standard deviation
† Total SD = total standard deviation

Table E-53 Rapidlab 1265 AutomaticQC Precision Results

Parameter Level n Mean WRSD* Total SD†


Ca++ 1 217 1.62 0.014 0.014

Ca++ 2 217 1.21 0.009 0.009

Ca++ 3 217 0.81 0.007 0.007

Cl- 1 218 80 0.44 0.46

Cl- 2 218 99 0.45 0.49

Cl- 3 218 120 0.60 0.68


Glu 1 218 203 1.29 1.47
Glu 2 218 102 0.72 0.96
Glu 3 218 51 0.56 0.67
K+ 1 218 2.99 0.045 0.045

K+ 2 218 4.99 0.065 0.071

K+ 3 218 7.01 0.088 0.097


Lac 1 179 11.8 0.24 0.39
Lac 2 179 1.0 0.03 0.04
Lac 3 179 3.0 0.06 0.09
Na+ 1 218 114.8 0.30 0.32

Na+ 2 218 134.6 0.38 0.41

Na+ 3 218 155.0 0.51 0.56


pCO2 1 215 70.8 0.48 0.77
pCO2 2 215 40.8 0.22 0.37
pCO2 3 215 22.5 0.13 0.27
pH 1 218 7.148 0.001 0.002
pH 2 218 7.349 0.002 0.002
pH 3 218 7.549 0.002 0.003
pO2 1 218 153.7 0.60 0.86

02087462 Rev.V
E-52 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-53 Rapidlab 1265 AutomaticQC Precision Results

Parameter Level n Mean WRSD* Total SD†


pO2 2 218 103.4 1.22 1.34
pO2 3 218 67.2 1.66 1.95
tHb 1 97 17.1 0.12 0.13
tHb 2 94 13.8 0.20 0.20
tHb 3 95 7.6 0.07 0.08
FO2Hb 1 97 77.3 0.84 0.94
FO2Hb 2 94 91.3 0.77 1.02
FO2Hb 3 95 60.5 0.88 1.07
FCOHb 1 97 6.1 0.78 1.30
FCOHb 2 94 5.9 0.70 1.44
FCOHb 3 95 18.7 0.92 1.46
FMetHb 1 97 17.1 0.32 0.35
FMetHb 2 94 2.8 0.88 0.89
FMetHb 3 95 5.7 0.54 0.55
FHHb 1 97 0.2 0.31 0.41
FHHb 2 94 0.4 0.40 0.64
FHHb 3 9 15.1 0.52 0.84
* WRSD = within-run standard deviation
† Total SD = total standard deviation

Recovery and Precision of Blood Gases, Electrolytes, and


Metabolites in Human Whole Blood
To prepare samples for analysis, blood was collected in heparinized vacuum tubes and
tonometered at 37°C to each of 6 levels to prepare samples for pH, Na+, K+, Cl-, and Ca++,
5 levels to prepare samples for glucose and lactate analysis, and 9 levels to prepare
samples for pCO2 and pO2 analysis. Multiple runs were performed using these samples on
a minimum of 3 Rapidlab 1265 systems.
These tables summarize the results of the Rapidlab 1265 system human whole blood
recovery precision testing.
Table E-54 Rapidlab 1265 Recovery and Precision Testing—pH

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.001 7.061 7.048 100.19 0.02
2 Capillary 18 0.001 7.237 7.231 100.09 0.01
3 Capillary 21 0.001 7.326 7.311 100.21 0.02
4 Capillary 18 0.001 7.429 7.423 100.09 0.02

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-53

Table E-54 Rapidlab 1265 Recovery and Precision Testing—pH

Level Mode N WRSD* Observed Expected Recovery WRCV


5 Capillary 21 0.003 7.545 7.526 100.25 0.04
6 Capillary 18 0.001 7.657 7.637 100.26 0.02
1 Syringe 45 0.013 7.048 7.048 100.01 0.19
2 Syringe 40 0.009 7.248 7.231 100.23 0.12
3 Syringe 45 0.002 7.313 7.311 100.03 0.03
4 Syringe 42 0.006 7.422 7.423 100.00 0.08
5 Syringe 45 0.005 7.528 7.526 100.01 0.07
6 Syringe 42 0.004 7.637 7.637 99.99 0.05
1 Micro- 12 0.003 7.038 7.048 99.86 0.04
capillary
2 Micro- 11 0.002 7.143 7.175 99.56 0.03
capillary
3 Micro- 12 0.002 7.346 7.338 100.10 0.03
capillary
4 Micro- 12 0.002 7.429 7.420 100.12 0.03
capillary
5 Micro- 12 0.002 7.530 7.541 99.85 0.03
capillary
6 Micro- 12 0.002 7.641 7.635 100.07 0.02
capillary
1 Micro- 24 0.003 7.054 7.048 100.09 0.04
syringe
2 Micro- 25 0.003 7.197 7.175 100.31 0.04
syringe
3 Micro- 24 0.004 7.335 7.338 99.95 0.05
syringe
4 Micro- 24 0.002 7.411 7.420 99.88 0.03
syringe
5 Micro- 24 0.003 7.547 7.541 100.08 0.04
syringe
6 Micro- 24 0.003 7.627 7.635 99.89 0.04
syringe
1 pH Only 21 0.002 7.028 7.045 99.75 0.03
Capillary
2 pH Only 21 0.001 7.212 7.227 99.80 0.02
Capillary
3 pH Only 20 0.004 7.339 7.329 100.14 0.05
Capillary

02087462 Rev.V
E-54 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-54 Rapidlab 1265 Recovery and Precision Testing—pH

Level Mode N WRSD* Observed Expected Recovery WRCV


4 pH Only 21 0.002 7.407 7.419 99.84 0.03
Capillary
5 pH Only 18 0.002 7.506 7.529 99.69 0.03
Capillary
6 pH Only 21 0.004 7.618 7.608 100.13 0.05
Capillary
1 pH Only 45 0.012 7.053 7.045 100.11 0.16
Syringe
2 pH Only 36 0.006 7.220 7.227 99.91 0.09
Syringe
3 pH Only 45 0.006 7.316 7.329 99.83 0.08
Syringe
4 pH Only 36 0.006 7.419 7.419 99.99 0.08
Syringe
5 pH Only 45 0.003 7.537 7.529 100.10 0.03
Syringe
6 pH Only 36 0.002 7.601 7.608 99.92 0.03
Syringe
1 pH, Glu, 24 0.009 7.068 7.063 100.07 0.12
Lac
Capillary
2 pH, Glu, 24 0.005 7.237 7.228 100.11 0.07
Lac
Capillary
3 pH, Glu, 21 0.006 7.311 7.320 99.88 0.08
Lac
Capillary
4 pH, Glu, 24 0.004 7.433 7.427 100.09 0.05
Lac
Capillary
5 pH, Glu, 21 0.005 7.553 7.550 100.03 0.07
Lac
Capillary
6 pH, Glu, 24 0.003 7.643 7.649 99.92 0.04
Lac
Capillary
1 pH, Glu, 42 0.009 7.075 7.071 100.05 0.12
Lac
Syringe

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-55

Table E-54 Rapidlab 1265 Recovery and Precision Testing—pH

Level Mode N WRSD* Observed Expected Recovery WRCV


2 pH, Glu, 48 0.006 7.240 7.234 100.07 0.08
Lac
Syringe
3 pH, Glu, 44 0.006 7.304 7.310 99.93 0.08
Lac
Syringe
4 pH, Glu, 48 0.003 7.441 7.439 100.02 0.04
Lac
Syringe
5 pH, Glu, 44 0.003 7.559 7.558 100.01 0.04
Lac
Syringe
6 pH, Glu, 48 0.004 7.647 7.650 99.96 0.05
Lac
Syringe
* WRSD = within-run standard deviation

Table E-55 Rapidlab 1265 Recovery and Precision Testing—pCO2

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.21 7.4 7.1 103.4 2.9
2 Capillary 21 0.32 22.4 21.3 105.0 1.4
3 Capillary 21 0.39 28.7 28.4 101.1 1.3
4 Capillary 24 0.29 36.4 35.4 102.9 0.8
5 Capillary 21 0.54 49.8 49.9 99.9 1.1
6 Capillary 21 0.73 72.3 71.1 101.7 1.0
7 Capillary 24 1.49 102.4 99.1 103.4 1.5
8 Capillary 21 0.81 133.4 135.4 98.5 0.6
9 Capillary 24 2.95 227.9 226.4 100.7 1.3
1 Syringe 45 0.19 7.0 7.1 97.9 2.7
2 Syringe 45 0.94 22.6 21.4 105.2 4.2
3 Syringe 44 0.38 28.7 28.6 100.2 1.3
4 Syringe 48 0.47 36.7 35.5 103.5 1.3
5 Syringe 45 1.07 50.0 49.9 100.3 2.1
6 Syringe 42 0.70 73.3 71.4 102.6 1.0
7 Syringe 48 1.59 99.9 99.3 100.7 1.6
8 Syringe 45 1.82 129.7 135.4 95.8 1.4
9 Syringe 48 2.29 222.5 227.0 98.0 1.0

02087462 Rev.V
E-56 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-55 Rapidlab 1265 Recovery and Precision Testing—pCO2

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Micro- 12 0.22 6.8 7.1 95.2 3.2
capillary
2 Micro- 12 0.28 21.3 21.3 99.7 1.3
capillary
3 Micro- 12 0.24 28.1 28.4 99.0 0.9
capillary
4 Micro- 12 0.18 35.9 35.8 100.3 0.5
capillary
5 Micro- 11 0.36 48.9 49.8 98.3 0.7
capillary
6 Micro- 12 0.53 70.2 71.1 98.9 0.8
capillary
7 Micro- 12 1.69 96.4 100.2 96.2 1.7
capillary
8 Micro- 12 3.48 133.2 135.1 98.6 2.6
capillary
9 Micro- 12 3.73 221.7 229.1 96.8 1.7
capillary
1 Micro- 24 0.21 6.8 7.1 96.8 3.1
syringe
2 Micro- 24 0.64 21.5 21.4 100.4 3.0
syringe
3 Micro- 24 0.45 28.3 28.6 99.1 1.6
syringe
4 Micro- 24 1.11 34.3 35.7 96.2 3.2
syringe
5 Micro- 24 0.96 47.6 49.5 96.3 2.0
syringe
6 Micro- 24 1.84 71.1 71.4 99.5 2.6
syringe
7 Micro- 24 4.35 95.6 99.8 95.7 4.6
syringe
8 Micro- 24 1.42 130.9 134.3 97.4 1.1
syringe
9 Micro- 24 5.21 217.7 228.2 95.4 2.4
syringe
* WRSD = within-run standard deviation

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-57

Table E-56 Rapidlab 1265 Recovery and Precision Testing—pO2

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.16 29.9 28.4 105.3 0.5
2 Capillary 21 0.32 49.8 49.9 99.8 0.6
3 Capillary 24 0.42 85.3 84.9 100.5 0.5
4 Capillary 21 0.46 105.9 106.9 99.1 0.4
5 Capillary 24 1.12 151.4 148.6 101.9 0.7
6 Capillary 21 1.02 200.2 199.0 100.6 0.5
7 Capillary 24 1.22 259.6 247.6 104.8 0.5
8 Capillary 21 3.25 378.3 376.7 100.4 0.9
9 Capillary 21 3.76 655.9 648.6 101.1 0.6
1 Syringe 42 0.38 29.9 28.6 104.7 1.3
2 Syringe 45 0.77 49.9 49.9 100.1 1.5
3 Syringe 48 0.67 86.4 85.1 101.5 0.8
4 Syringe 45 0.47 104.8 106.9 98.0 0.4
5 Syringe 48 3.58 151.4 148.9 101.7 2.4
6 Syringe 44 1.29 200.2 200.1 100.1 0.6
7 Syringe 48 1.76 259.0 248.2 104.3 0.7
8 Syringe 45 1.35 381.9 378.7 100.8 0.4
9 Syringe 45 10.03 644.1 648.7 99.3 1.6
1 Micro- 12 0.40 27.8 28.4 97.6 1.4
capillary
2 Micro- 11 0.35 48.2 49.8 96.8 0.7
capillary
3 Micro- 12 0.32 85.7 85.9 99.8 0.4
capillary
4 Micro- 12 0.97 107.1 106.7 100.4 0.9
capillary
5 Micro- 12 1.68 149.6 150.4 99.5 1.1
capillary
6 Micro- 12 2.66 196.8 198.9 98.9 1.4
capillary
7 Micro- 12 2.79 262.1 250.6 104.6 1.1
capillary
8 Micro- 12 1.75 374.3 376.6 99.4 0.5
capillary
9 Micro- 12 8.03 646.6 647.0 99.9 1.2
capillary

02087462 Rev.V
E-58 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-56 Rapidlab 1265 Recovery and Precision Testing—pO2

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Micro- 24 0.41 28.0 28.6 98.0 1.5
syringe
2 Micro- 24 0.22 48.3 49.5 97.5 0.5
syringe
3 Micro- 24 0.97 84.1 85.6 98.3 1.1
syringe
4 Micro- 24 1.53 105.5 106.1 99.5 1.5
syringe
5 Micro- 24 1.17 149.9 149.7 100.1 0.8
syringe
6 Micro- 24 2.52 200.5 199.9 100.3 1.3
syringe
7 Micro- 24 2.74 263.0 249.6 105.4 1.0
syringe
8 Micro- 24 4.31 376.9 378.4 99.6 1.1
syringe
9 Micro- 24 8.16 640.8 643.4 99.6 1.3
syringe
* WRSD = within-run standard deviation

Table E-57 Rapidlab 1265 Recovery and Precision Testing—Na+

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.18 113.6 111.2 102.1 0.2
2 Capillary 21 0.19 129.6 129.4 100.1 0.1
3 Capillary 21 0.42 134.0 134.4 99.7 0.3
4 Capillary 21 0.84 142.1 141.5 100.4 0.6
5 Capillary 21 0.25 147.4 148.6 99.2 0.2
6 Capillary 21 1.06 175.3 179.8 97.5 0.6
1 Syringe 45 0.41 113.5 111.2 102.1 0.4
2 Syringe 45 0.40 129.0 129.4 99.6 0.3
3 Syringe 45 0.36 133.6 134.4 99.4 0.3
4 Syringe 43 0.33 140.1 141.5 99.0 0.2
5 Syringe 42 0.25 148.5 148.6 99.9 0.2
6 Syringe 45 0.65 173.7 179.8 96.6 0.4
1 Micro- 12 0.56 110.0 109.9 100.1 0.5
capillary
2 Micro- 12 0.27 129.9 130.1 99.9 0.2
capillary

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-59

Table E-57 Rapidlab 1265 Recovery and Precision Testing—Na+

Level Mode N WRSD* Observed Expected Recovery WRCV


3 Micro- 12 0.11 133.3 132.0 101.0 0.1
capillary
4 Micro- 12 0.60 144.0 143.8 100.1 0.4
capillary
5 Micro- 12 0.40 150.4 150.8 99.7 0.3
capillary
6 Micro- 12 0.83 177.6 178.1 99.7 0.5
capillary
1 Micro- 24 0.71 109.7 109.9 99.8 0.6
syringe
2 Micro- 24 0.30 130.4 130.1 100.2 0.2
syringe
3 Micro- 24 0.35 132.2 132.0 100.2 0.3
syringe
4 Micro- 24 0.44 144.1 143.8 100.2 0.3
syringe
5 Micro- 24 0.68 151.2 150.8 100.3 0.5
syringe
6 Micro- 24 1.09 179.5 178.1 100.8 0.6
syringe
* WRSD = within-run standard deviation

Table E-58 Rapidlab 1265 Recovery and Precision Testing—K+

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 24 0.043 1.10 1.18 92.8 3.9
2 Capillary 21 0.028 2.54 2.63 96.5 1.1
3 Capillary 21 0.046 4.16 4.12 101.0 1.1
4 Capillary 21 0.036 6.04 5.74 105.2 0.6
5 Capillary 24 0.120 7.99 7.99 100.0 1.5
6 Capillary 21 0.115 11.48 11.31 101.5 1.0
1 Syringe 45 0.113 1.10 1.18 92.7 10.3
2 Syringe 45 0.027 2.63 2.63 99.9 1.0
3 Syringe 45 0.010 4.08 4.12 98.9 0.3
4 Syringe 45 0.065 5.65 5.74 98.4 1.2
5 Syringe 45 0.108 8.24 7.99 103.0 1.3
6 Syringe 45 0.153 11.87 11.31 104.9 1.3

02087462 Rev.V
E-60 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-58 Rapidlab 1265 Recovery and Precision Testing—K+

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Micro- 11 0.063 1.27 1.15 110.4 4.9
capillary
2 Micro- 12 0.035 2.77 2.82 98.0 1.3
capillary
3 Micro- 12 0.066 3.85 3.77 101.9 1.7
capillary
4 Micro- 12 0.034 5.63 5.71 98.6 0.6
capillary
5 Micro- 12 0.085 7.72 8.05 95.9 1.1
capillary
6 Micro- 11 0.242 12.28 11.97 102.6 2.0
capillary
1 Micro- 25 0.091 1.15 1.15 99.6 7.9
syringe
2 Micro- 24 0.034 2.78 2.82 98.7 1.2
syringe
3 Micro- 24 0.016 3.77 3.77 99.8 0.4
syringe
4 Micro- 24 0.058 5.71 5.71 100.1 1.0
syringe
5 Micro- 24 0.134 8.22 8.05 102.1 1.6
syringe
6 Micro- 24 0.280 12.38 11.97 103.4 2.3
syringe
* WRSD = within-run standard deviation

Table E-59 Rapidlab 1265 Recovery and Precision Testing—Cl-

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.38 72 73 99.2 0.5
2 Capillary 21 0.38 90 91 99.6 0.5
3 Capillary 21 0.38 97 98 99.3 0.3
4 Capillary 21 0.38 105 106 98.5 0.6
5 Capillary 21 0.38 111 111 99.8 0.4
6 Capillary 20 0.38 148 148 100.0 1.4
1 Syringe 45 0.38 70 71 98.0 1.4
2 Syringe 45 0.38 90 91 99.7 0.5
3 Syringe 45 0.42 99 99 100.2 0.4
4 Syringe 43 0.69 106 105 100.3 0.7

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-61

Table E-59 Rapidlab 1265 Recovery and Precision Testing—Cl-

Level Mode N WRSD* Observed Expected Recovery WRCV


5 Syringe 42 0.38 110 111 99.7 0.3
6 Syringe 45 0.98 146 146 100.6 0.7
1 Micro- 12 0.68 80 80 100.1 0.9
capillary
2 Micro- 12 0.43 98 98 100.1 0.4
capillary
3 Micro- 12 0.43 98 100 98.8 0.4
capillary
4 Micro- 12 0.53 104 105 98.8 0.5
capillary
5 Micro- 11 0.31 116 117 99.5 0.3
capillary
6 Micro- 12 1.22 141 141 99.3 0.9
capillary
1 Micro- 24 0.53 81 81 100.1 0.7
syringe
2 Micro- 24 0.31 95 96 99.5 0.3
syringe
3 Micro- 24 0.37 98 99 98.8 0.4
syringe
4 Micro- 24 0.78 106 106 99.9 0.7
syringe
5 Micro- 24 0.65 117 116 101.0 0.6
syringe
6 Micro- 24 1.63 145 144 101.1 1.1
syringe
* WRSD = within-run standard deviation

Table E-60 Rapidlab 1265 Recovery and Precision Testing—Ca++

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 18 0.009 0.57 0.58 97.0 1.6
2 Capillary 21 0.015 1.26 1.26 100.2 1.2
3 Capillary 18 0.004 1.34 1.36 98.4 0.3
4 Capillary 21 0.023 1.90 1.93 98.7 1.2
5 Capillary 18 0.026 2.29 2.36 97.1 1.1
6 Capillary 21 0.039 4.08 4.09 99.6 1.0
1 Syringe 40 0.011 0.55 0.58 94.6 2.0
2 Syringe 45 0.009 1.25 1.26 99.3 0.7

02087462 Rev.V
E-62 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-60 Rapidlab 1265 Recovery and Precision Testing—Ca++

Level Mode N WRSD* Observed Expected Recovery WRCV


3 Syringe 42 0.012 1.33 1.36 97.7 0.9
4 Syringe 45 0.022 1.91 1.93 99.0 1.1
5 Syringe 42 0.043 2.30 2.36 97.8 1.9
6 Syringe 45 0.062 4.24 4.09 103.7 1.5
1 Micro- 11 0.015 0.57 0.56 100.5 2.6
capillary
2 Micro- 12 0.016 1.24 1.24 100.0 1.3
capillary
3 Micro- 12 0.005 1.29 1.30 99.8 0.4
capillary
4 Micro- 12 0.044 1.97 1.98 99.5 2.2
capillary
5 Micro- 12 0.046 2.36 2.38 99.4 1.9
capillary
6 Micro- 12 0.071 3.97 3.98 99.8 1.8
capillary
1 Micro- 25 0.023 0.51 0.56 91.1 4.5
syringe
2 Micro- 24 0.012 1.26 1.24 101.4 1.0
syringe
3 Micro- 24 0.016 1.30 1.30 100.4 1.3
syringe
4 Micro- 24 0.026 2.00 1.98 101.1 1.3
syringe
5 Micro- 24 0.044 2.43 2.38 102.2 1.8
syringe
6 Micro- 24 0.121 4.20 3.98 105.7 2.9
syringe
* WRSD = within-run standard deviation

Table E-61 Rapidlab 1265 Recovery and Precision Testing—Glucose

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 21 0.87 48 45 106.9 1.8
2 Capillary 21 2.55 90 89 101.0 2.8
3 Capillary 21 2.04 210 210 100.0 1.0
4 Capillary 21 3.56 326 349 93.4 1.1
5 Capillary 21 3.66 450 470 95.8 0.8
1 Syringe 39 1.37 42 38 110.8 3.3

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-63

Table E-61 Rapidlab 1265 Recovery and Precision Testing—Glucose

Level Mode N WRSD* Observed Expected Recovery WRCV


2 Syringe 40 1.57 87 82 105.5 1.8
3 Syringe 45 2.02 214 211 101.2 0.9
4 Syringe 45 2.24 339 358 94.9 0.7
5 Syringe 42 5.25 477 472 101.1 1.1
1 Micro- 12 2.02 43 44 96.8 4.7
capillary
2 Micro- 12 2.47 86 88 97.9 2.9
capillary
3 Micro- 12 1.41 224 219 102.4 0.6
capillary
4 Micro- 12 7.42 332 343 96.7 2.2
capillary
5 Micro- 12 4.21 447 452 98.8 0.9
capillary
1 Micro- 24 1.76 48 48 101.0 3.7
syringe
2 Micro- 24 2.05 99 98 101.1 2.1
syringe
3 Micro- 24 1.87 226 222 102.1 0.8
syringe
4 Micro- 24 18.80 367 374 98.1 5.1
syringe
5 Micro- 24 8.40 456 452 100.9 1.8
syringe
1 pH, Glu, 21 0.83 52 44 116.5 1.6
Lac
Capillary
2 pH, Glu, 24 1.80 98 93 106.3 1.8
Lac
Capillary
3 pH, Glu, 24 2.60 203 205 99.4 1.3
Lac
Capillary
4 pH, Glu, 24 3.93 355 365 97.3 1.1
Lac
Capillary
5 pH, Glu, 21 9.84 495 526 94.2 2.0
Lac
Capillary

02087462 Rev.V
E-64 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-61 Rapidlab 1265 Recovery and Precision Testing—Glucose

Level Mode N WRSD* Observed Expected Recovery WRCV


1 pH, Glu, 48 1.13 51 43 118.9 2.2
Lac
Syringe
2 pH, Glu, 48 2.57 96 87 110.0 2.7
Lac
Syringe
3 pH, Glu, 45 4.67 215 215 99.7 2.2
Lac
Syringe
4 pH, Glu, 46 5.21 371 384 96.4 1.4
Lac
Syringe
5 pH, Glu, 48 5.71 494 520 95.0 1.2
Lac
Syringe
* WRSD = within-run standard deviation

Table E-62 Rapidlab 1265 Recovery and Precision Testing—Lactate

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Capillary 18 0.06 1.6 1.6 102.9 3.5
2 Capillary 21 0.04 2.1 2.2 95.4 2.1
3 Capillary 18 0.10 5.1 5.2 96.3 1.9
4 Capillary 21 0.12 9.6 11.0 87.4 1.2
5 Capillary 18 0.17 12.7 14.4 88.1 1.3
1 Syringe 39 0.04 1.2 1.3 96.2 3.5
2 Syringe 42 0.05 2.3 2.2 101.5 2.1
3 Syringe 38 0.10 5.5 5.6 98.4 1.8
4 Syringe 45 0.15 9.9 10.9 90.8 1.5
5 Syringe 36 0.26 13.4 14.4 92.9 1.9
1 Micro- 12 0.05 1.1 1.0 104.4 4.7
capillary
2 Micro- 12 0.12 4.1 4.4 93.4 2.9
capillary
3 Micro- 12 0.07 5.8 6.7 87.1 1.2
capillary
4 Micro- 12 0.06 9.5 11.5 82.5 0.7
capillary
5 Micro- 12 0.51 13.1 16.2 80.9 3.9
capillary

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-65

Table E-62 Rapidlab 1265 Recovery and Precision Testing—Lactate

Level Mode N WRSD* Observed Expected Recovery WRCV


1 Micro- 24 0.06 1.2 1.2 98.6 5.1
syringe
2 Micro- 24 0.06 3.3 3.6 90.6 2.0
syringe
3 Micro- 24 0.14 5.9 6.4 93.0 2.3
syringe
4 Micro- 24 0.23 9.7 10.8 89.4 2.3
syringe
5 Micro- 24 0.23 11.9 13.9 85.9 2.0
syringe
1 pH, Glu, 21 0.05 0.9 0.9 109.7 5.1
Lac
Capillary
2 pH, Glu, 21 0.07 2.8 2.8 98.5 2.6
Lac
Capillary
3 pH, Glu, 15 0.06 4.9 5.3 92.9 1.3
Lac
Capillary
4 pH, Glu, 21 0.13 10.5 12.1 86.4 1.2
Lac
Capillary
5 pH, Glu, 15 0.25 14.2 17.4 81.5 1.7
Lac
Capillary
1 pH, Glu, 41 0.03 0.9 0.8 106.5 3.1
Lac
Syringe
2 pH, Glu, 45 0.08 2.5 2.7 93.5 3.2
Lac
Syringe
3 pH, Glu, 45 0.11 5.5 6.0 91.4 1.9
Lac
Syringe
4 pH, Glu, 42 0.33 10.8 12.5 86.9 3.1
Lac
Syringe
5 pH, Glu, 45 0.34 14.8 17.9 82.8 2.3
Lac
Syringe
* WRSD = within-run standard deviation

02087462 Rev.V
E-66 Rapidlab 1200 Operator’s Guide: System Specifications

Recovery and Precision of Hemoglobin Fractions in Human


Whole Blood
For testing capillary, tHb, and syringe modes, blood was collected in heparinized vacuum
tubes. It was tonometered at 37°C or adjusted chemically. Three target levels of tHb were
prepared by separating the red cells from the plasma and recombining appropriately. For
each run, 3 replicates of each level were run on a minimum of 3 Rapidlab 1265 systems.
The mean bias was determined by taking the difference between the Rapidlab 1265 system
mean and the reference methods mean. The mean bias and the pooled within run standard
deviation were determined for each blood preparation and sampling mode.
The following tables summarize the results of the Rapidlab 1265 CO-ox module recovery
and precision testing.
Table E-63 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~6 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
tHb Capillary 61 6.20 0.29 0.08
tHb tHb 55 6.19 0.29 0.15
tHb Syringe 58 6.16 0.23 0.05
FO2Hb Capillary 63 86.67 -1.65 0.21
FO2Hb tHb 56 87.21 -1.27 0.42
FO2Hb Syringe 60 86.46 -1.52 0.34
FCOHb Capillary 63 5.00 0.67 0.21
FCOHb tHb 57 4.82 0.86 0.41
FCOHb Syringe 60 4.80 0.87 0.27
FMetHb Capillary 63 4.80 0.22 0.08
FMetHb tHb 57 5.48 -0.16 0.09
FMetHb Syringe 61 4.89 -0.06 0.10
FHHb tHb 55 2.68 -0.05 0.32
FHHb Capillary 63 3.54 0.29 0.14
FHHb Syringe 61 3.77 0.03 0.21
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation

Table E-64 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
tHb Capillary 60 14.14 0.33 0.12
tHb tHb 62 14.17 0.18 0.14

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-67

Table E-64 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~14 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
tHb Syringe 63 14.06 0.27 0.08
FO2Hb Capillary 62 85.68 -0.55 0.17
FO2Hb tHb 63 86.21 -0.54 0.30
FO2Hb Syringe 63 85.57 -0.30 0.26
FCOHb Capillary 62 5.29 0.05 0.15
FCOHb tHb 63 4.98 0.28 0.22
FCOHb Syringe 63 4.69 0.34 0.21
FMetHb Capillary 62 5.08 -0.05 0.05
FMetHb tHb 63 4.86 -0.23 0.08
FMetHb Syringe 63 5.39 -0.37 0.07
FHHb tHb 63 3.94 -0.05 0.22
FHHb Capillary 62 3.96 0.07 0.11
FHHb Syringe 63 4.35 -0.38 0.24
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation

Table E-65 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~20 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
tHb Capillary 65 20.11 0.25 0.14
tHb tHb 53 20.11 0.08 0.11
tHb Syringe 62 20.27 0.06 0.10
FO2Hb Capillary 65 85.19 1.04 0.21
FO2Hb tHb 54 86.59 1.43 0.29
FO2Hb Syringe 62 84.89 1.17 0.26
FCOHb Capillary 65 5.13 -0.90 0.14
FCOHb tHb 54 6.29 -0.91 0.32
FCOHb Syringe 62 5.13 -0.89 0.16
FMetHb Capillary 65 5.41 -0.20 0.07
FMetHb tHb 54 6.10 -0.39 0.07
FMetHb Syringe 62 5.45 -0.36 0.06
FHHb tHb 54 1.01 -0.75 0.11
FHHb Capillary 65 4.27 -0.36 0.13

02087462 Rev.V
E-68 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-65 Rapidlab 1265 CO-ox Module Recovery and Precision with Total
Hemoglobin of ~20 g/dL and Oxyhemoglobin > 75%
Mean
Analyte Mode* n Reference Mean Bias WRSD†
FHHb Syringe 62 4.53 -0.52 0.22
* tHb mode performance is equivalent to sample device used
† WRSD: within-run standard deviation

Method Comparison with Human Whole Blood Samples


For testing syringe and capillary modes, blood was collected in heparinized vacuum tubes.
It was tonometered at 37°C and/or adjusted chemically. Several levels of tHb were
prepared by separating the red cells from the plasma and recombining appropriately.
Specimens were assayed on Rapidlab 1265 and Rapidlab 865 systems.
Method comparison was quantified by obtaining estimates of proportional (slope), and
constant (intercept) bias, root mean square error (RMSE), and method correlation (R
square for r2 coefficient of determination) by performing an ordinary least squares
analysis of the Rapidlab 1265 (dependent variable) versus the Rapidlab 865 (independent
variable). Results are summarized in the table below.
Table E-66 Rapidlab 1265 Human Whole Blood Method Comparison—pH

Mode N Slope Intercept RMSE r2 Min Max


Capillary 117 0.996 0.036 0.006 0.999 7.052 7.691
Syringe 259 1.005 -0.030 0.009 0.998 7.010 7.696
Micro- 71 0.986 0.104 0.006 0.999 7.020 7.643
capillary
Micro- 145 0.991 0.064 0.006 0.999 7.022 7.646
syringe
pH Only 122 1.003 -0.020 0.008 0.998 7.017 7.643
Capillary
pH Only 243 1.006 -0.051 0.008 0.998 7.012 7.645
Syringe
pH, Glu, 138 0.986 0.106 0.009 0.998 7.044 7.652
Lac
Capillary
pH, Glu, 274 0.991 0.070 0.008 0.998 7.054 7.661
Lac
Syringe
Table E-67 Rapidlab 1265 Human Whole Blood Method Comparison—pCO2

Mode N Slope Intercept RMSE r2 Min Max


Capillary 198 1.014 0.211 3.179 0.998 7.0 238.2
Syringe 410 0.958 2.020 4.038 0.996 6.1 233.9

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-69

Table E-67 Rapidlab 1265 Human Whole Blood Method Comparison—pCO2

Mode N Slope Intercept RMSE r2 Min Max


Micro- 107 1.011 -0.480 3.939 0.996 6.0 232.5
capillary
Micro- 216 0.991 -0.772 3.258 0.997 5.9 232.3
syringe
Table E-68 Rapidlab 1265 Human Whole Blood Method Comparison—pO2

Mode N Slope Intercept RMSE r2 Min Max


Capillary 198 0.999 1.888 5.745 0.999 29.2 676.3
Syringe 410 0.979 4.294 8.343 0.998 28.3 683.6
Micro- 107 0.967 3.922 7.086 0.999 26.3 674.4
capillary
Micro- 216 0.964 3.089 8.702 0.998 26.4 676.1
syringe

Table E-69 Rapidlab 1265 Human Whole Blood Method Comparison—Na+


Mode N Slope Intercept RMSE r2 Min Max
Capillary 193 0.991 1.159 1.506 0.994 107.6 180.2
Syringe 387 1.003 -0.417 1.528 0.995 105.4 182.8
Micro- 137 1.006 -0.603 1.532 0.995 108.1 189.5
capillary
Micro- 209 1.021 -2.613 1.521 0.995 104.2 187.5
syringe

Table E-70 Rapidlab 1265 Human Whole Blood Method Comparison—K+

Mode N Slope Intercept RMSE r2 Min Max


Capillary 215 0.987 0.082 0.183 0.997 1.35 12.27
Syringe 431 1.021 -0.084 0.179 0.997 1.02 12.27
Micro- 143 1.007 0.005 0.182 0.997 1.37 11.85
capillary
Micro- 278 1.015 -0.042 0.169 0.997 1.06 12.27
syringe

Table E-71 Rapidlab 1265 Human Whole Blood Method Comparison—Ca++

Mode N Slope Intercept RMSE r2 Min Max


Capillary 117 1.088 -0.103 0.092 0.994 0.52 4.59
Syringe 259 1.108 -0.133 0.090 0.995 0.49 4.86
Micro- 71 1.008 -0.016 0.050 0.998 0.52 4.35
capillary

02087462 Rev.V
E-70 Rapidlab 1200 Operator’s Guide: System Specifications

Table E-71 Rapidlab 1265 Human Whole Blood Method Comparison—Ca++

Mode N Slope Intercept RMSE r2 Min Max


Micro- 145 1.071 -0.093 0.068 0.997 0.44 4.67
syringe

Table E-72 Rapidlab 1265 Human Whole Blood Method Comparison—Cl-

Mode N Slope Intercept RMSE r2 Min Max


Capillary 126 1.055 -4.597 1.382 0.996 70 150
Syringe 265 1.084 -7.862 1.621 0.995 62 151
Micro- 72 0.907 15.580 1.647 0.992 86 145
capillary
Micro- 144 0.938 12.479 1.556 0.994 85 154
syringe
Table E-73 Rapidlab 1265 Human Whole Blood Method Comparison—Glucose

Mode N Slope Intercept RMSE r2 Min Max


Capillary 193 0.896 15.91 25.41 0.987 47 806
Syringe 387 0.899 19.57 31.62 0.981 45 774
Micro- 138 0.879 12.881 23.914 0.987 43 693
capillary
Micro- 214 0.874 16.078 29.439 0.979 43 736
syringe
pH, Glu, 114 0.922 13.641 9.440 0.997 48 520
Lac
Capillary
pH, Glu, 235 0.926 13.831 8.804 0.997 43 530
Lac
Syringe
Table E-74 Rapidlab 1265 Human Whole Blood Method Comparison—Lactate

Mode N Slope Intercept RMSE r2 Min Max


Capillary 96 0.874 0.410 0.423 0.991 1.1 14.6
Syringe 200 0.904 0.241 0.768 0.972 0.8 16.9
Micro- 60 0.783 0.564 0.382 0.992 1.0 14.8
capillary
Micro- 120 0.796 0.523 0.551 0.983 0.9 14.2
syringe
pH, Glu, 93 0.804 0.474 0.403 0.993 0.8 15.2
Lac
Capillary

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-71

Table E-74 Rapidlab 1265 Human Whole Blood Method Comparison—Lactate

Mode N Slope Intercept RMSE r2 Min Max


pH, Glu, 218 0.817 0.392 0.494 0.991 0.7 16.1
Lac
Syringe
Table E-75 Rapidlab 1265 Human Whole Blood Method Comparison—tHb

Mode N Slope Intercept RMSE r2


tHb 296 0.961 0.657 0.515 0.991
Capillary 326 0.963 0.789 0.490 0.992
Syringe 331 0.967 0.620 0.479 0.993
Table E-76 Rapidlab 1265 Human Whole Blood Method Comparison—
FO2Hb

Mode N Slope Intercept RMSE r2


tHb 276 0.999 -0.468 2.188 0.995
Capillary 308 1.002 -0.727 1.740 0.996
Syringe 310 0.995 0.072 1.837 0.996
Table E-77 Rapidlab 1265 Human Whole Blood Method Comparison—
FCOHb

Mode N Slope Intercept RMSE r2


tHb 193 0.978 0.078 1.095 0.999
Capillary 208 0.994 -0.130 0.921 0.999
Syringe 205 0.990 0.094 0.997 0.998
Table E-78 Rapidlab 1265 Human Whole Blood Method Comparison—
FMetHb

Mode N Slope Intercept RMSE r2


tHb 208 0.981 0.029 1.019 0.999
Capillary 212 1.025 0.015 0.914 0.999
Syringe 205 0.978 0.027 0.992 0.999
Table E-79 Rapidlab 1265 Human Whole Blood Method Comparison—
FHHb

Mode N Slope Intercept RMSE r2


tHb 136 1.001 0.535 1.514 0.998
Capillary 144 0.991 0.661 1.554 0.998
Syringe 152 0.954 0.442 1.282 0.999

02087462 Rev.V
E-72 Rapidlab 1200 Operator’s Guide: System Specifications

Reference Methods
The following reference or comparative methods were used to generate data for the
Rapidlab 1200 systems.
Analyte Reference Method
pH Internal ISE method used.
pCO2 and pO2 Tonometered whole blood. Refer to CLSI document C46-A.2 Gases
used are traceable to NIST Certified Reference Material SRM 1701.
Na+ and K+ Internal ISE method used.

Cl- Coulometric reference method.

Ca++ Internal ISE method used.


Glucose The hexokinase/glucose-6-phosphate dehydrogenase method
described in CLSI document RS1-A.4
Lactate Internal method using lactate oxidase assay.
tHb Cyanmethemoglobin Reference Method per Clinical and Laboratory
Standards Institute (CLSI), approved reference procedure5 using a
spectrophotometer.
FO2Hb Tonometry, where whole blood samples are tonometered with 95%
O2, and 5% CO2.
FHHb Tonometry, where whole blood samples are tonometered with 95%
N2, and 5% CO2.
FCOHb Reduced gas Chromatography.6
FMetHb Modified Evelyn-Malloy7 method utilizing a spectrophotometer.

02087462 Rev.V
Rapidlab 1200 Operator’s Guide: System Specifications E-73

Calibrator Traceability
Analyte Traceability
pH Traceable to NIST SRM 186 reference material via the IFCC
reference method.1
pCO2 and pO2 Traceable to tonometered aqueous standards prepared using NIST
traceable temperature and pressure standards and gravimetrically
prepared precision gas standards.
Na+ and K+ Traceable to NIST SRM 919 or 918 reference materials using flame
photometry3 or atomic absorption.
Cl- Traceable to NIST SRM 919 or 918 reference materials using a
coulometric reference method.
Ca++ Traceable to gravimetrically prepared internal standards using NIST
SRM 915 and ISE methods embodied in the Siemens systems.
Glucose Traceable to NIST standard reference materials using the hexokinase/
glucose-6-phosphate dehydrogenase method.4
Lactate Traceable to commercially available standards using a manual
spectrophotometric method.
tHb Traceable to internal standards calibrated against the CLSI
Cyanomethemoglobin Reference Method.5
FO2Hb, Spectral properties traceable to NIST gravimetric standards and
FHHb, verified by assessing tHb versus internal standard calibrated against
FCOHb, the CLSI Cyanomethemoglobin method.
FMetHb

References
1. International Federation of Clinical Chemistry. Reference method (1986) for
pH measurement in blood. IFCC 1987/3.
2. Clinical and Laboratory Standards Institute. Blood Gas and pH Analysis and
Related Measurements; Approved Guideline; CLSI Document C 46-A; (Vol.
21, No. 14); Sept 2001.
3. Clinical and Laboratory Standards Institute. Standardization of Sodium and
Potassium Ion-Selective Electrode Systems to the Flame Photometric
Reference Method; Approved Standard-Second Edition; CLSI Document
C29 A2; (Vol. 20, No. 17); Oct 2000.
4. Clinical and Laboratory Standards Institute. NRSCL Glucose. CLSI
Document RS1-A; Mar 1989.
5. Clinical and Laboratory Standards Institute. Reference and Selected
Procedures for the Quantitative Determination of Hemoglobin in Blood;
Approved Standard - Third Edition. CLSI Document H15-A3, (Vol. 20,
No. 28); Jan 2000.

02087462 Rev.V
E-74 Rapidlab 1200 Operator’s Guide: System Specifications

6. Vreman HJ, Kwong LK, Stevenson DK. Carbon Monoxide in Blood: an Improved
Microliter Blood-Sample Collection System, with Rapid Analysis by Gas
Chromatography, Clin. Chem. 30, 1984:1382-1386.
7. Evelyn KA, and Malloy HT. Microdetermination of Oxihemoglobin, Methemoglobin
and Sulfhemoglobin in a Single Sample of Blood. J Biol. Chem. 1938;126:655-662.

02087462 Rev.V
Appendix F: Symbols

This section describes the symbols that may be on the exterior of the system or on
packaging. The symbols on the system provide you with the location of certain
components and with warnings for proper operation. The symbols on the system
or packaging provide you with other important information.
Symbol Description
indicates where you insert the sample device (syringe,
capillary, or ampule) to perform analysis

indicates a risk of exposure to biohazards

indicates a hazard or danger is associated with the product

indicates a risk of exposure to potential electrical hazards

indicates that the input electricity is alternating current

indicates important information about the fuses

indicates that the main power supply is on

indicates that the main power supply is off

Class 1 indicates that the system is Class 1 type equipment having


basic insulation and additional safety grounding precautions
indicates a caution or warning.
Refer to Section 1, Using This Guide, Conventions.

indicates that the system is listed by UL as meeting safety


requirements for medical equipment with respect to electrical
shock, fire and mechanical hazards only in accordance with
UL 60601-1, Can/CSA C22.2 No.601-1
indicates that the system meets the requirements of the
European Union

indicates the area where you write the date you install the
cartridge on the system, if required

02087462 Rev. V
F-2 Rapidlab 1200 Operator’s Guide: Symbols

Symbol Description
indicates that you should not spray this area with cleaning
solutions or other fluids that may damage parts of the system

indicates in vitro diagnostic medical device

indicates you should avoid looking directly into the light beam
of the laser to prevent possible exposure to hazardous light

indicates you should consult instructions for use

indicates a temperature limitation, as in store between


2–8°C

indicates the system contains sufficient for (n) tests (250 tests)

indicates a use by date

catalog number

serial number

batch code

manufacturer

Authorized Representative in the European Community

02087462 Rev. V
Appendix G: Glossary

amperometry 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).
anion The ion in an electrolyzed solution that migrates to the
anode.
anode The electrode in an electrochemical cell at which
oxyidation occurs.
AQC AutomaticQC
AQC Valve test moves the valve for the AutomaticQC cartridge to
prescribed positions
banner The top portion of the touchscreen.
cathode The electrode in an electrochemical cell at which
reduction occurs.
cation The ion in an electrolyzed solution that migrates to the
cathode.
CO-ox Pump test moves the CO-ox pump at various speeds, Performing
the CO-ox Pump Test‚ page 6-42
Only on the Rapidlab 1245 and 1265 systems.
Eject AQC Cartridge ejects the AutomaticQC cartridge, Ejecting the
AutomaticQC Cartridge‚ page 6-43
Eject R Cartridge ejects the reagent cartridge, Ejecting the Wash or
Reagent Cartridge‚ page 6-43
Eject W Cartridge ejects the wash cartridge, Ejecting the Wash or Reagent
Cartridge‚ page 6-43
Lamp Cal test verifies the proper operation of the CO-ox lamp,
determines the optimum settings for the lamp, and
prints the results (passed or failed)
Only on the Rapidlab 1245 and 1265 systems.
Lamp On/Off test turns the CO-ox lamp on and off
Only on the Rapidlab 1245 and 1265 systems.
Last Cal test prints data for each sensor from the last 2-point or full
calibration, Using the Sensors Screen‚ page 6-44
Leak test tests the fluidic integrity of the sample path for leaks
and prints the results, Performing the Leak Test‚
page 6-37

02087462 Rev. V
G-2 Rapidlab 1200 Operator’s Guide: Glossary

LIS Laboratory Information System.


Potentiometry Measures 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
Prime AQC Cartridge test moves the individual levels of QC material while you
verify proper flow, Priming the AQC Cartridge‚
page 6-37
Printer test prints all printable characters providing the system ID,
the date and time of the report, and the printer data,
Performing Tests and Printing Diagnostic Reports‚
page 6-34
RCx A calibrator contained in the wash cartridge.
Reagent Flow test moves the individual reagents (200 cal and Slope cal
from the reagent cartridge and wash and RCx from the
wash cartridge) while you verify proper fluid flow,
Performing the Reagent Flow Tests‚ page 6-36
R Valve moves the valve for the reagent cartridge to prescribed
positions, Performing the R Cartridge Valve Test‚
page 6-40
Sample Chamber verifies the proper operation of the CO-ox sample
chamber and prints the results, Performing the CO-ox
Pump Test‚ page 6-42
Only on the Rapidlab 1245 and 1265 systems.
Sample Pump moves the sample pump at various speeds, Performing
the Sample Pump and Wash Pump Tests‚ page 6-39
Sensors outputs the raw sensor signals in mV or nA
For Field Service use only.
Temperature test prints the temperature for various system components
and the current pAtm providing the system ID, the date
and time of the report, and temperature information,
Performing Tests and Printing Diagnostic Reports‚
page 6-34
Voltage and Temperatures prints the voltage and temperatures, Performing Tests
test and Printing Diagnostic Reports‚ page 6-34
Wash Pump moves the wash pump at various speeds, Performing the
Sample Pump and Wash Pump Tests‚ page 6-39
Waste Detector Calibration calibrates the waste detector, Performing the Waste
Detector Calibration‚ page 6-35
Wavelength Cal verifies the proper operation of the CO-ox neon lamp
and prints the results providing the system ID, the date
and time of the report, Performing the Wavelength Cal
Test‚ page 6-46
Only on the Rapidlab 1245 and 1265 systems.

02087462 Rev. V
Appendix H: Rapidlab 1200 System Maintenance Checklist

Appendix H provides Maintenance Checklist charts for you to record maintenance activities performed on the Rapidlab 1200 series system.

Make photocopies of these charts as necessary and record your maintenance activities according to the maintenance protocol of your institution.

Month/Year:

System ID:

Daily Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check System Status
Clean the Exterior
Surfaces

Twice Weekly Maintenance


Week 1 Week 2 Week 3 Week 4
Analyze High G/L

Weekly Maintenance
Week 1 Week 2 Week 3 Week 4
Deproteinize the
Sample Path
Condition the Sensors
Check the Fill Solution
Levels

02087462 Rev. V
H-2 Rapidlab 1200 Operator’s Guide:

Every 60 Days Maintenance


2 Months 4 Months 6 Months 8 Months 10 Months 12 Months
Replace the CO-ox
Sample Chamber
Check the Air Filters

Quarterly Maintenance
3 Months 6 Months 9 Months 12 Months
Replace the Pinch
Valve Tubing

Yearly Maintenance
Replace the Measurement Module Tubing
Replace the CO-ox Module Tubing
Replace the Reagent Manifold
Replace the AutomaticQC Manifold
Replace the Air Filters

As Required Maintenance
Replace the Measurement Module Tubing
Replace the CO-ox Module Tubing
Replace the Reagent Manifold
Replace the AutomaticQC Manifold
Replace the Air Filters

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Index I-1

Index retaining 8-6


automaticQC samples 4-3
a-v extraction index
A description 1-62
accessing a-v study
setup menu 8-1 description 1-61
air filters report 2-37
checking 5-9 B
replacing 5-9, 5-20 bar code
alphanumeric characters problems 6-8
selecting to enter for patient ID field in setup 8-10 scanning patient ID 2-23
alveolar-arterial oxygen tension difference bar code scanner
description 1-60 bar code symbologies 8-24
analysis screen connecting the bar code scanner 8-26
custom panels 2-20 defining the patient ID, accession number, and pass-
sample options 1-22 word bar codes 8-23
selecting QC sample type in setup 8-13 entering fixed lengths for Interleaved 2 of 5 8-24
selecting the sample type in setup 8-13 resetting 6-9
analytical range limits 8-40 troubleshooting 6-8
analyzing patient samples barometric sensor
a-v study report 2-35 calibrating 5-3
capillary 2-12 base excess
CO-ox Only 2-18 description 1-54
entering patient sample data 2-22 bicarbonate ion
microsamples 2-14 description 1-54
pH Only 2-17 biosensor
analyzing QC samples 4-1 replacing sensor 5-29
AutomaticQC 4-3 buttons
high G/L 5-3 functions of buttons 1-21
required QC 4-4 C
analyzing samples calcium adjustment for pH
syringe 2-11 description 1-59
anion gap calcium sensor 1-45
description 1-59 calcium, ionized
AQC cartridge measuring 1-44
reinstallation 2-4 calibrating
AQC valve test 6-41 barometric sensor 5-3
arterial-alveolar oxygen tension ratio touch screen 6-35
description 1-60 waste detector 6-35
arterial-venous (a-v) Study calibration 3-1
description 1-61 calibration points for reagents 1-9
arterial-venous oxygen content difference defined 3-1
description 1-62 effect of turning parameters off and on 8-14
authorized representative B-1, B-9 features of system 3-3
automaticQC 4-3 recalling results 3-4
change target ranges to default 8-6 report 6-5
repeat analysis for failed parameter 8-5 report examples 3-3
retaining target ranges 8-6 troubleshooting failed 6-4
selecting setup options 8-3, 8-5 understanding automatic 3-1
automaticQC cartridge viewing and printing data 7-4
capacity 1-4, 1-5 calibration message
contents of levels 1-4 selecting in setup 8-41
eject cartridge 6-43 calibrations
automaticQC manifold troubleshooting failed 6-4
replacing 5-19 calibrator traceability E-73
automaticQC ranges capillary samples

02087462 Rev. V
I-2 Rapidlab 1200 Operator’s Guide: Index

analyzing 2-12 daily maintenance 5-2


carboxyhemoglobin (FCOHb) data entry
measurement principles 1-50 early demographics 2-24
checking date
air filters 5-9 changing 8-20
barometer 5-2 changing the century for date of birth 8-10
fill solution 5-7 changing the date format 8-20
system status 5-2 date of birth
chloride changing the century 8-10
measuring 1-43 default 8-11
sensor 1-44 default custom panel 8-11
cleaning defining
CO-ox roller cage 5-25 custom panels 8-11
exterior surfaces 5-2 demographics
reference sensor 5-34 allowing editing of demographics 8-39
sample path 5-22 demographics needed to determine results 8-17
screen 5-21 editing 2-25
waste assembly 5-27 entering 2-22
communication problems 6-12 sample demographics
CompleNet selecting units of measure 8-15
using the CompleNet network connection 8-28 selecting patient and sample demographics in setup
conditioning the sensors 5-6 8-9
CO-ox lamp selecting required demographics 8-9
replacing 5-43 deoxyhemoglobin (FHHb)
CO-ox module 1-18 measurement principles 1-49
components 1-18, 1-51 diagnostic data
CO-ox module tubing copying 7-3
replacing 5-13 diagnostic tests
CO-ox Only samples lamp calibration test 6-45
analyzing 2-18 leak tests 6-37
CO-ox pump test 6-42 measurement module pinch valve test 6-41
CO-ox roller cage prime AQC cartridge tests 6-37
cleaning 5-25 R cartridge valve test 6-40
replacing 5-45 reagent flow tests 6-36
CO-ox sample chamber sample pump test 6-39
replacing 5-9 wash pump test 6-39
CO-ox sample chamber test 6-46 waste detector calibration test 6-35
CO-ox sample path disinfecting
removing obstructions 6-31 exterior surfaces 5-2
copying data 2-34, 7-2 screen 5-21
file names and formats 7-1 disposing of the system 5-50
copying diagnostic data 7-3 E
copying stored results 7-2 early demographics data entry 2-24
correlation coefficients editing
entering 8-44 demographics 2-25
custom panels eject AQC cartridge 6-43
default 8-11 eject reagent cartridge test 6-43
defining 8-11 eject wash cartridge test 6-43
microsample 8-12 entering
using 2-20 patient sample data 2-22
customer service B-9 entering data 1-3
Customized QC Range Limits 8-3 estimated shunt
D description 1-63
D codes Ethylene Glycol interference E-11
overview 6-47 every 60 days maintenance 5-9
qualifiers 6-47

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Index I-3

F installing software 8-42


failed calibrations viewing number of samples analyzed 7-4
troubleshooting checklist 6-4 measurement cartridge
failed QC reagents 1-9
troubleshooting checklist 6-3 measurement module
fetal hemoglobin 1-50 components 1-16, 1-17
file names and formats measurement module pinch valve test 6-41
for copied data 7-1 measurement module tubing
fill solution levels replacing 5-12
checking 5-7 measurement sensors
fill volumes C-1 checking fill solution 5-8
full calibration 3-4 replacing fill solutions 5-32, 5-40
G replacing sensor 5-29
gas exchange indices measurement technology
description 1-60 CO-ox module 1-51
glucose and lactate biosensors references 1-65
measurement principles messages
lactate biosensor 1-46 selecting the language for screens and messages 8-20
H system 6-74
Hct methemoglobin (FMetHb)
using 8-14 measurement principles 1-50
high G/L 5-3 microsample custom panel 8-12
I microsamples
installation analyzing 2-14
installing new system software 8-42 fill volumes C-1
installing the system 5-49 moving the system 5-49
intended use 1-1 O
Interference Testing E-6 O2SAT and O2CT
ionselective electrode using 8-14
illustration 1-32 operating principles 1-27
Irenat interference E-10 amperometry 1-33
L measuring electrolytes 1-40
lamp calibration test 6-45 chloride 1-43
lamp on/off test 6-47 ionized calcium 1-44
language potassium 1-42
selecting the language 8-20 sodium 1-42
leak test 6-37 measuring metabolites 1-45
leak test results glucose 1-45
printed and onscreen 6-37 lactate 1-46
LIS measuring pCO2 1-35
communication problems 6-12 measuring pH 1-33
connecting the system to the LIS 8-30 measuring pO2 1-38
send calibration results 3-4 potentiometry 1-27
Logs Only button 7-3 oxygen capacity (hemoglobin)
M description 1-57
maintenance oxygen consumption
daily 5-2 description 1-62
every 90 days 5-36 oxygen content (hemoglobin)
quarterly 5-10 description 1-56, 1-57
twice weekly 5-3 oxygen content of arterial blood
weekly 5-4 description 1-61
yearly 5-11 oxygen content of mixed venous blood
maintenance checklist H-1 description 1-61
managing data oxygen delivery
copying data 2-34, 7-2 description 1-62
copying stored results 7-2 oxygen saturation (estimated)

02087462 Rev. V
I-4 Rapidlab 1200 Operator’s Guide: Index

description 1-58 description 1-55


oxygen saturation (hemoglobin) pCO2
description 1-56 measuring 1-35
oxyhemoglobin (FO2Hb) sensor 1-37
measurement principles 1-49 performance
P 1240 data E-11
p50 1245 data E-18
description 1-58 1260 data E-30
packing the system 5-50 1265 data E-49
parameter status 1-22 limitations E-5
parameters 1-1 performing sensor and electrode maintenance 5-34
correlation coefficients 8-44 pH
defining patient ranges 8-7 measuring 1-33
description 1-52 sensor 1-35
Hct 8-14 pH, and pH,Glu,Lac samples
O2SAT and O2CT 8-14 analyzing 2-17
parameters needed to determine other results 8-17 physiologic shunt
reported 1-52 description 1-63
restore failed QC 4-12 pinch valve tubing
restore missed QC 4-12 replacing 5-10
status 1-22 pO2
tHb 8-14 sensor 1-39
turning off 8-10 measuring 1-38
viewing number of samples analyzed for each parame- pO2/FIO2
ter 7-4 description 1-59
passwords potassium
adding, editing, or deleting operator IDs and passwords measuring 1-42
8-37 sensor 1-43
entering 2-1 prime AQC cartridge test 6-37
notify expiration pending 8-37 printed reports
selecting system security 8-35 full calibration 6-5
patient ID field last cal G-1
selecting to enter alphanumeric characteristics in setup wavelength cal 6-46, G-2
8-10 printer paper
patient results replacing 5-42
editing demographics 2-25 printer problems 6-11
printing 2-27 printing
recalling 2-30 calibration results 3-4
troubleshooting 6-6 diagnostic reports 6-34
viewing 2-27 patient results 2-27
patient sample data 2-22 printing reports automatically 8-32
patient sample types recalled patient results 2-30
arterial 1-22 turning the printer on or off 8-32
capillary 1-22 proficiency testing
mixed-venous 1-22 selecting to display question results for tHb 8-39
venous 1-22 Q
patient samples QC
allowing editing of demographics 8-39 analyzing automaticQC samples 4-3
anticoagulant requirements 2-7 analyzing unscheduled QC samples 4-4
defining patient ranges 8-7 failed QC 4-7
handling techniques for whole blood 2-9 missed QC 4-7
sample devices 2-7, 2-8 required QC samples 4-1
sample volume 2-7 restoring parameters 4-7
selecting the sample type in setup 8-13 selecting automaticQC analysis options 8-3, 8-5
patient search 2-28 troubleshooting 6-1
patient temperature correction QC analysis

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Index I-5

performing 4-1 CO-ox sample path 6-31


QC material sample path 6-24
contents of automaticQC cartidge 1-4 replacing
QC options 4-1 air filters 5-20
QC results automaticQC cartridge 2-3
recalling 4-7 automaticQC manifold 5-19
search 4-8 CO-ox lamp 5-43
QC samples CO-ox module tubing 5-13
about QC analysis 4-1 CO-ox roller cage 5-45
analyzing QC samples 4-1 CO-ox sample chamber 5-9
selecting QC syringe type in setup 8-13 measurement module tubing 5-12
QC syringe type pinch valve tubing 5-10
turn on or off at analysis screen 8-13 printer paper 5-42
quarterly maintenance 5-10 reagent cartridge 2-3
R reagent manifold 5-17
R cartridge valve test 6-41 sample port 5-42
rapid sample identification sensors 5-29
selecting in setup 8-9 system fuses 5-47
Rapidlink and Rapidcomm systems wash cartridge 2-2
communication problems 6-12 waste bottle 2-2
connecting the system to a Rapidlink or Rapidcomm reports
system 8-27 calibration(examples) 3-3
using a CompleNet network connection 8-28 effects of changing units of measure 8-15
using a serial connection 8-27 representative
send calibration results 3-4 authorized B-1, B-9
send patient results 2-27 required QC analysis 4-1
RCx cal test 6-36 benefits of using 4-1
reagent cartridge defined 4-1
replacing 2-3 effect of turning parameters off and on in setup 8-14
reagent flow tests 6-36 turning on the bar code scanner 8-23
reagent manifold respiratory index
replacing 5-17 description 1-61
reagents 1-9 restore system setup data 8-41
calibration points 1-9 restoring parameters 4-12
recalling result symbols
calibration results 3-4 calibration 6-5
patient results 2-30 patient 2-27
QC results 4-12 QC 4-6
reference electrode results screen 2-27
illustration 1-32 retaining automaticQC ranges 8-6
reference methods E-72 RiliBÄK 8-2
reference sensor S
checking fill solution 5-8 sample analysis 3-1
cleaning 5-34 viewing number of samples analyzed 7-4
replacing sensor 5-29 sample devices
reference sensor maintenance 5-36 anticoagulant requirements 2-7
refilling fill volumes C-1
measurement sensors 5-32, 5-40 patient samples 2-7, 2-8
reinstalling the automaticQC cartridge 2-4 sample ground/temperature sensor
relocating the system 5-49 replacing sensor 5-29
remote viewing sample path
enabling 8-32 cleaning 5-22
setup 8-32 deproteinizing 5-4
using buttons in banner 8-34 sample port
remote viewing status in banner 1-20 replacing 5-42
removing obstructions sample pump test 6-38

02087462 Rev. V
I-6 Rapidlab 1200 Operator’s Guide: Index

sample totals notify password expiration pending 8-38


viewing number of samples analyzed 7-4 operator IDs and passwords 8-37
save demographics parameter selection 8-10
selecting in setup 8-38 patient ranges 8-7
save system setup data 8-41 QC
scanning patient ID automaticQC analysis options 8-3, 8-5
data entry screen 2-23 rapid sample identification 8-9
screen elements 1-3 sample type 8-13
screens save and restore system setup data 8-41
Results 2-27 save demographics 8-38
search security access 8-35
performing a patient 2-29 system name 8-21
QC data 4-8 time 8-20
security touch sound 8-21
adding, editing, or deleting operator IDs and passwords setup menu 8-1
8-37 shipping the system 5-50
selecting system security 8-35 shutting down 2-6
selecting sO2 as a measured or calculated value 8-30 Slope Cal test 6-36
send sodium
calibration results 3-4 measuring 1-42
patient results 2-27 sensor 1-42
QC target ranges 8-4 software
restore parameters 4-12 installing new system software 8-42
sensors solving
checking fill solution 5-7 bar code problems 6-8
conditioning 5-6 communication problems 6-12
measurement principles printer problems 6-11
calcium sensor 1-45 touch screen problems 6-11
chloride sensor 1-44 sound
glucose and lactate biosensors 1-46 turning the touch sound off 8-21
lactate 1-46 STAT
pCO2 sensor 1-37 analyzing priority sample 2-11
pH sensor 1-35 stored results
pO2 sensor 1-39 copying 7-2
potassium sensor 1-43 storing the system 5-50
reference sensor 1-31 sulfhemoglobin (SulfHb)
sodium sensor 1-42 measurement principles 1-50
measurement technology supplies
references 1-65 ordering supplies D-1
refilling 5-32, 5-40 replacing 2-2
removing obstructions 6-26, 6-28 replacing the waste bottle 2-2
replacing 5-29 symbols
service B-1, B-9 calibration results 6-5
under warranty B-1 patient results 2-27
setup QC results 4-6
accessing setup options 8-1 recall patient results 2-30
adjusting system and video volume 8-21 system and packaging F-1
bar code options troubleshooting patient results 6-6
connecting the bar code scanner 8-26 syringe samples
calibration message 8-41 analyzing 2-11
correlation coefficients 8-44 system
date 8-20 shutting down 2-6
date format 8-20 starting up 2-1
demographics 8-9 system messages 6-74
demographics editing 8-39 system name
language 8-20 defining 8-21

02087462 Rev. V
Rapidlab 1200 Operator’s Guide: Index I-7

system status Y
checking 5-2 yearly maintenance 5-11
T
target ranges
change to default automaticQC ranges 8-6
retaining for automaticQC 8-6
temperature in banner 1-20
tHb
measurement principles 1-49
see CO-ox module 1-49
using 8-14
time
changing 8-20
total carbon dioxide
description 1-55
touch screen
calibrating 6-35
features 1-1
problems 6-11
selecting the language for screens and messages 8-20
turning the touch sound off 8-21
troubleshooting
bar code problems 6-8
communication problems 6-12
failed calibrations 6-4
failed QC 6-1
missed QC 6-1
patient results 6-6
printer problems 6-11
system messages 6-74
touch screen problems 6-11
unavailable buttons 6-7
twice weekly maintenance 5-3
U
unscheduled QC samples 4-4
V
viewing number of samples analyzed 7-4
volume
adjusting for system and video sound 8-21
W
warranty B-1
wash cartridge
replacing 2-2
wash cycle 6-36
wash functionality at Analysis screen 2-12
wash pump test 6-39
wash test 6-36
waste assembly
cleaning 5-27
waste bottle
replacing 2-2
waste components
illustration 1-13
waste detector
calibrating 6-35
weekly maintenance 5-4

02087462 Rev. V
I-8 Rapidlab 1200 Operator’s Guide: Index

02087462 Rev. V

You might also like