RAPIDLab 348EX

System

Operator's Guide

10698292 Rev. E, 2022-02

 © 2013–2022 Siemens Healthcare Diagnostics. All rights reserved.
No part of this operator’s guide or the products it describes may be
reproduced by any means or in any form without prior consent in
writing from Siemens Healthcare Diagnostics.
MULTICAP, RAPIDLab, RAPIDComm, and RAPIDQC are trademarks of
Siemens Healthcare Diagnostics.
All other trademarks are the property of their respective owners.

Origin GB Siemens Healthineers

Siemens Healthcare Diagnostics Inc. Headquarters
511 Benedict Avenue Siemens Healthcare GmbH
Tarrytown, NY 10591-5097 USA Henkestr. 127
91052 Erlangen
Siemens Healthcare Diagnostics Germany
Manufacturing Ltd. Phone: +49 9131 84-0
Chapel Lane siemens-healthineers.com
Swords, Co. Dublin, Ireland
siemens-healthineers.com/poc

The information in this operator’s guide was correct at the time of

printing. However, Siemens Healthcare Diagnostics 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 from that specified by
Siemens Healthcare Diagnostics, the protection provided by the
equipment may be impaired. See warning and hazard statements.

RAPIDLab 348EX Operator’s Guide Part #10698292 Rev. E, 2022-02

Contents

Contents

Using This Guide

Who Should Use This Guide . . . . . . . . . . . . . . . . . . . . . . . . . 15
Conventions Used in this Manual . . . . . . . . . . . . . . . . . . . . 15
Understanding the Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1 Safety Information
Read This First . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
General Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . 17
Agency Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Safety Certifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . 18
Protecting Yourself from Biohazards. . . . . . . . . . . . . . . . . . 18
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Using and Replacing Reagents and Supplies . . . . . . . . . . . 21
Handling Compressed Gas Cartridges. . . . . . . . . . . . . . . . . 22
Protecting Yourself from the Barcode Reader Beam . . . . . 22
Protecting Yourself from Electrical Hazards . . . . . . . . . . . . 22

2 Introduction
Intended Use of the RAPIDLab 348EX System . . . . . . . . . . 23
Summary and Explanation . . . . . . . . . . . . . . . . . . . . . . . . . . 24

3 Handling Samples and Reagents

Collecting Blood Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Sample Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Sample Collection Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Capillary Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Vacuum Tube Collection Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

RAPIDLab 348EX Operator’s Guide page 3

 Handling and Storing Samples . . . . . . . . . . . . . . . . . . . . . . 28
Dialysis Fluid Sample Handling . . . . . . . . . . . . . . . . . . . . . . 30
Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Active Ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Intended Use of Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Shelf Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Handling and Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

4 System Operation
Materials Provided . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Special Materials Required (Not Provided) . . . . . . . . . . . . 33
Powering Up the RAPIDLab 348EX System . . . . . . . . . . . . 33
What You Can Do during Warmup. . . . . . . . . . . . . . . . . . . . . . . . . 34
When the System Reaches Operating Temperature . . . . . . . . . . . 34
Selecting Options and Entering Data . . . . . . . . . . . . . . . . . 34
Entering Your Operator ID and Password . . . . . . . . . . . . . 35
Entering Your Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Entering Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Menu Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Analyzing Syringe Samples . . . . . . . . . . . . . . . . . . . . . . . . . 36
Entering Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Analyzing Capillary Samples . . . . . . . . . . . . . . . . . . . . . . . . 38
Interpreting Results, Syringe and Capillary Samples . . . . 40
Analyzing Dialysis Fluid Samples . . . . . . . . . . . . . . . . . . . . 41
Measuring a Micro Sample . . . . . . . . . . . . . . . . . . . . . . . . . 42
Measuring a Short Sample or a Sample with a Bubble. . . 43
Continuing with the Short or Bubble Sample Analysis . . . . . . . . . 43
Cancelling the Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Recalling Sample Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Viewing Recalled Sample Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Entering Patient Data for a Recalled Sample . . . . . . . . . . . . . . . . . 46
Printing Recalled Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Entering Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

page 4 RAPIDLab 348EX Operator’s Guide

 Restarting from Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

5 Calibrating Your System

Selecting Calibration Method and Entering Gas Values . . 49
Choosing the Calibration Timing Mode. . . . . . . . . . . . . . . . . . . . . 49
Automatic Calibrations, Independent of Timing Mode . . . . . . . . . . . . 50
Selecting Calibration Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Calibrating Gas Values for the pCO₂ and pO₂ Sensors . . . . . . . . . 51
Calibrating the Barometer . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Recalling and Printing Calibration Data . . . . . . . . . . . . . . . 52
Automatically Printing a Calibration Summary . . . . . . . . . . . . . . . 52
Manually Printing a Calibration Summary. . . . . . . . . . . . . . . . . . . 52
Requesting Additional Calibrations. . . . . . . . . . . . . . . . . . . 52
Checking Hct Slope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Diagnosing and Fixing Causes of Calibration Failures . . . 53
Calibrating the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . 54

6 Quality Control
Handling QC Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Default QC Operating Setup. . . . . . . . . . . . . . . . . . . . . . . . . 56
Changing the Default QC Operating Setup . . . . . . . . . . . . 56
Analyzing QC Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Recalling and Printing QC Data . . . . . . . . . . . . . . . . . . . . . . 57
Recalling, Viewing, and Printing a QC Result . . . . . . . . . . . . . . . . 57
Printing a QC Statistical Report . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

7 Maintenance
Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Accessing Maintenance Functions . . . . . . . . . . . . . . . . . . . 60
Daily Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Weekly Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Every-Other-Week Maintenance (or as Prompted via the
Action List) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Quarterly Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

RAPIDLab 348EX Operator’s Guide page 5

 Six-month Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Using the Action List to Prompt for Maintenance. . . . . . . 63
Emptying the Waste Bottle . . . . . . . . . . . . . . . . . . . . . . . . . 64
Checking the Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Changing the Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Deproteinizing the Sensors . . . . . . . . . . . . . . . . . . . . . . . . . 67
Conditioning the Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Disinfectants to Use with the Disinfect Routine . . . . . . . . 69
Using the Disinfect Routine . . . . . . . . . . . . . . . . . . . . . . . . . 69
Stopping the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Using the Prime Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Draining the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Priming the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Changing the Gas Cartridges. . . . . . . . . . . . . . . . . . . . . . . . 72
Checking the Gas Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . 74
Changing the Pump Tubing and Cleaning and Lubricating
the Rollers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Changing the Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Changing the Sample Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Changing the Reagent Pump Tubing. . . . . . . . . . . . . . . . . . . . . . . . . . .76
Cleaning the Rollers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Lubricating the Rollers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Installing New Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Installing New Sample Pump Tubing. . . . . . . . . . . . . . . . . . . . . . . . . . .79
Installing New Reagent Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . .79
Refilling or Replacing the Measurement Sensors . . . . . . . 80
Refilling the pH, Na⁺, K⁺, Ca⁺⁺, or Cl⁻ Sensor . . . . . . . . . . . . . . . . . 81
Reinstalling the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Replacing the Reference Sensor Cassette or Inner
Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Replacing the Bottle Tubing . . . . . . . . . . . . . . . . . . . . . . . . 87
Cleaning or Replacing the Drip Tray . . . . . . . . . . . . . . . . . . 88
Replacing the Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . 90
Replacing the Probe and Tubing and Probe Housing . . . . 92
Removing the Current Probe, Tubing, and Housing . . . . . . . . . . . 92

page 6 RAPIDLab 348EX Operator’s Guide

 Reassembling the Probe and Housing . . . . . . . . . . . . . . . . . . . . . . 95
Replacing the Reference Sensor while Replacing Probe . . . . . . . . 96
Replacing the Pre-heater Tube. . . . . . . . . . . . . . . . . . . . . . . 98
Clearing Blockages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Clearing a Blockage in the Probe . . . . . . . . . . . . . . . . . . . . . . . . . 101
Clearing a Blockage in the Pre-heater . . . . . . . . . . . . . . . . . . . . . 101
Clearing a Blockage in the Sensors . . . . . . . . . . . . . . . . . . . . . . . 102
Clearing a Blockage in the Drip Tray Connector Drain Hole . . . . 102
Clearing a Blockage in the Manifold . . . . . . . . . . . . . . . . . . . . . . 104
Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

8 Troubleshooting
System Setup or Power Faults . . . . . . . . . . . . . . . . . . . . . . 111
General Troubleshooting Procedures . . . . . . . . . . . . . . . . 111
System Not Ready . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Calibration Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Viewing the Calibration Summary on the Screen . . . . . . . . . . . . 112
Printing the Calibration Summary . . . . . . . . . . . . . . . . . . . . . . . . 113
Calibration or Slope Drift . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Calibration or Slope No Endpoint . . . . . . . . . . . . . . . . . . . . . . . . 117
Calibration or Slope Outside Range. . . . . . . . . . . . . . . . . . . . . . . 120
Fluidics Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Suspect Patient Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
General Procedure When Suspect Patient Results Occur . . . . . . 125
Suspect Results, Possible Causes and Corrective Actions . . . . . . 126
Sample Not Detected or Sampling Faults . . . . . . . . . . . . . 127
Printer Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Heater Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Using the Troubleshooting Routines. . . . . . . . . . . . . . . . . 129
Measurement Block Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Run Test Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Sample Flow Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Heater Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Electronics Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Roll Printer Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

RAPIDLab 348EX Operator’s Guide page 7

 Sensors Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Other Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

9 Data Management
Managing Sample Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Managing QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Managing Calibration Summary Data . . . . . . . . . . . . . . . 139

10 System Installation and Configuration

Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . 142
Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Installing the Measurement Sensors . . . . . . . . . . . . . . . . . . . . . . 143
Installing the Reference Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Connecting the Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Installing the Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Installing the Gas Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Installing the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . 147
Physical Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Setting the Barcode Reading Mode . . . . . . . . . . . . . . . . . . . . . . . 147
Installing a USB Memory Stick. . . . . . . . . . . . . . . . . . . . . . 149
Powering-Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Configuring Operating Setup . . . . . . . . . . . . . . . . . . . . . . 149
QC Ranges Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
QC Prompts Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Setting Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Configuring Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Setting Printer Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Adjusting Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Configuring System Setup . . . . . . . . . . . . . . . . . . . . . . . . . 154
Changing Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Setting the Maintenance Prompts . . . . . . . . . . . . . . . . . . . . . . . . 154
Selecting Measurement Parameters . . . . . . . . . . . . . . . . . . . . . . 155
Selecting Calculated Parameters . . . . . . . . . . . . . . . . . . . . . . . . . 155
Turning the Beeper Off or On . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Changing Communication Options . . . . . . . . . . . . . . . . . . . . . . . 156

page 8 RAPIDLab 348EX Operator’s Guide

 Setting Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Printing the Setup Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Service Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Entering System Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Changing Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Appendix A: Concepts and Reference Information

RAPIDLab 348EX System Overview . . . . . . . . . . . . . . . . . . 159
The Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Back Panel Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Using the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Menu Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Main Menu Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Action List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Sensor Deselection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Calibration Setup Options and Values. . . . . . . . . . . . . . . . 165
Default Calibration Setup Options and Values . . . . . . . . . . . . . . 165
Calibration Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Selecting Calibration Method and Entering Gas Values . . . . . . . 165
Recalling and Printing Calibration Data . . . . . . . . . . . . . . 165
Requesting Additional Calibrations. . . . . . . . . . . . . . . . . . 166
Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Setting Reference Ranges (All Measured Parameters) . . 167
Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Reference Ranges Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Configuring the System . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Setting Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Requiring an Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Requiring a Menu Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Appendix B: Warranty and Support Information

Standard Instrument Warranty and Service Delivery
Policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Warranty Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

RAPIDLab 348EX Operator’s Guide page 9

 Warranty Service During Normal Business Hours . . . . . . . . . . . . 171
Extent of a Warranty Service Call. . . . . . . . . . . . . . . . . . . . . . . . . 171
Warranty Service Outside Normal Hours . . . . . . . . . . . . . . . . . . . 172
Replacement of Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Design Changes and Retrofitting of Instruments . . . . . . . . . . . . 172
Key Operator Designation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
OSHA Requirements (US only). . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Warranty Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Warranty Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Limitations of Siemens Original Warranty . . . . . . . . . . . . . . . . . . 174
IT Security. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Disposal of the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Appendix C: Orderable Supplies

Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Orderable Spares . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Appendix D: Interfacing to External Devices

LIS 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
LIS 1 Data Format (default) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
LIS 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
LIS 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

Appendix E: References

Appendix F: Specifications
Measurement Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Measured Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Calculated Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Limit of Quantitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
RAPIDLab 348EX Parameter Linearity . . . . . . . . . . . . . . . . . . . . . . . . 192
RAPIDLab 348EX Interfering Substances . . . . . . . . . . . . . . . . . . . 193
Irenat Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Method Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

page 10 RAPIDLab 348EX Operator’s Guide

 pH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
pCO₂ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
pO₂ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Na⁺ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
K⁺. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Ca⁺⁺ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Cl⁻ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Hct. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Micro Sample Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
pH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
pCO₂ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
pO₂ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Na⁺ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
K⁺. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Ca⁺⁺ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Cl⁻ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Hct. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Method Comparison - RL348EX Blood Gas . . . . . . . . . . . . . . . . . 198
Method Comparison - RL348EX Dialysis Fluid. . . . . . . . . . . . . . . 198
Precision and Recovery on Whole Blood . . . . . . . . . . . . . . 199
Level 1 ............................................. 199
Level 2 ............................................. 199
Level 3 ............................................. 200
Level 4 ............................................. 200
Level 5 ............................................. 201
Level 6 ............................................. 201
Precision on Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
pH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
H⁺ (nmol/L). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
pCO₂ (mmHg) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
pCO₂ (kPa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
pO₂ (mmHg). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
pO₂ (kPa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Na⁺ (mmol/L) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
K⁺ (mmol/L) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Ca⁺⁺ (mmol/L). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Cl⁻ (mmol/L) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Hct (%) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

RAPIDLab 348EX Operator’s Guide page 11

 Measurement Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Sample Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Display and Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . 205
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Measurement Range - Dialysis Fluid Mode . . . . . . . . . . . 206
Measured Parameters - Dialysis Fluid Mode . . . . . . . . . . . . . . . . 206
Calculated Parameters - Dialysis Fluid Mode . . . . . . . . . . . . . . . . 207
Accuracy on Measured Parameters - Dialysis Fluid
Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Within-run Precision - Dialysis Fluid Mode . . . . . . . . . . . 207
Sample Size - Dialysis Fluid Mode . . . . . . . . . . . . . . . . . . . 207

Appendix G: Symbols
System and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

Appendix H: Operating Principles

Potentiometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Amperometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
Conductivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
Reference Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
pH Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Na⁺ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

page 12 RAPIDLab 348EX Operator’s Guide

 K⁺ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Ca⁺⁺ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Cl⁻ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
pCO₂ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
pO₂ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Hct Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
Measuring pH, Blood Gases, Electrolytes, and Hct . . . . . 224
pH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
pCO₂ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
pO₂ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
Hct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
Na⁺ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
K⁺ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Ca⁺⁺ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Cl⁻. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Calculated Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Bicarbonate Ion (HCO₃⁻) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Actual Bicarbonate (HCO₃⁻act) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
Standard Bicarbonate (HCO₃⁻std) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
Base Excess . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
Base Excess of Extracellular Fluid (BE(ecf)) . . . . . . . . . . . . . . . . . . . . 230
Base Excess of Blood (BE(B)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Oxygen Content (O₂CT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Oxygen Saturation (Estimated) . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Total Carbon Dioxide (ctCO₂). . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
Patient Temperature Correction . . . . . . . . . . . . . . . . . . . . . . . . . 232
ctHb(est) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
Gas Exchange Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Alveolar O₂ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Arterial-Alveolar Oxygen Tension Difference. . . . . . . . . . . . . . . . . . . 233
Arterial-Alveolar Oxygen Tension Ratio . . . . . . . . . . . . . . . . . . . . . . . 233
Calcium Adjustment for pH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
Anion Gap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
pO₂/FIO₂ Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
Actual Bicarbonate (HCO₃⁻act) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Standard Bicarbonate (HCO₃⁻std) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Base Excess of Extracellular Fluid (BE(ecf)) . . . . . . . . . . . . . . . . . . . . 235
Base Excess of Blood (BE(B)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Oxygen Content (O₂CT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235

RAPIDLab 348EX Operator’s Guide page 13

 Oxygen Saturation (Estimated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Total Carbon Dioxide (ctCO₂). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Patient Temperature Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Arterial-Alveolar Oxygen Tension Difference . . . . . . . . . . . . . . . . . . 236
Arterial-Alveolar Oxygen Tension Ratio. . . . . . . . . . . . . . . . . . . . . . . 236

Index

page 14 RAPIDLab 348EX Operator’s Guide

Using This Guide

Who Should Use This Guide

The RAPIDLab® 348EX System Operator’s Guide provides information for
clinical laboratory professionals who use the system, specifically, for:
• Routine operators
Medical or laboratory personnel who use the system to analyze patient
and QC samples, to view and print results, and to perform routine
maintenance.
• System supervisors
Laboratory supervisors or designated key operators who perform Setup
functions, monitor the use of the system, and assist with
troubleshooting and maintenance when necessary.

Conventions Used in this Manual

This manual uses the following text and symbol conventions.

Convention Description
Warning statements provide information about
conditions that may cause injury to personnel.
Caution statements provide information about
conditions that may cause product damage.
Biohazard statements alert you to potentially
biohazardous conditions.
Note Note statements alert you to important information
that requires your attention.
Bold Bold type within text indicates a user selection, such
as the path to a particular screen or the name of a
button on the touch screen; for example, Calibration.
> A separator in the navigational path leading to a
particular screen; for example, Ready > Settings >
System Setup > Print Setup Report.

RAPIDLab 348EX Operator’s Guide page 15

 Understanding the Symbols
Certain symbols appear on the exterior of the system or on the packaging.
The symbols on the system show you the location of certain components
and may contain warnings for proper operation. The symbols on the
system or packaging provide you with other important information. For a
complete list of the symbols used in this guide, see Appendix G, Symbols.

page 16 RAPIDLab 348EX Operator’s Guide

1 Safety Information

Read This First

Your personal safety is of paramount importance, therefore please read
this section before operating the RAPIDLab 348EX system. This section
summarizes the following procedures for protecting yourself from
biohazards, laser hazards, and electrical hazards:
• General Safety Information, page 17
• Protecting Yourself from Biohazards, page 18
• Operating Precautions, page 20
• Using and Replacing Reagents and Supplies, page 21
• Handling Compressed Gas Cartridges, page 22
• Protecting Yourself from the Barcode Reader Beam, page 22
• Protecting Yourself from Electrical Hazards, page 22

General Safety Information

WARNING
Do not use an ungrounded outlet with this equipment. The system is
designed to be grounded through the power supply lead (line cord) for
safe operation. For the safety of operating personnel and optimum
performance make sure that the instrument is connected only to a
grounded power outlet that has an effective earth connection. If you use
an adapter, ensure that the grounding wire is properly connected to a
permanent ground.

The system has no internal user-replaceable parts. Do not remove the back
cover from the system.
Siemens Healthcare Diagnostics and its authorized representatives are
responsible for the safety, reliability and performance of the
RAPIDLab 348EX system only if:
• Assembly operations, extensions, re-adjustments, modifications or
repairs are carried out only by persons authorized by them.
• The electrical installation of the relevant room complies with IEC
requirements or the local regulatory code.

RAPIDLab 348EX Operator’s Guide page 17

Safety Information

• The equipment is used in accordance with the instructions for use, and
by persons knowledgeable in safe laboratory practices.

The RAPIDLab 348EX system is classed as IEC Type B equipment (Class 1

equipment providing an adequate degree of protection against electric
shocks particularly regarding allowable leakage currents and reliability of
the protective earth connection).

Agency Standards
The system is not designed for use in an environment containing a
flammable anaesthetic mixture with air, oxygen or nitrous oxide and is not
designed to give protection against the ingress of liquids.

The system has been tested for safety by TUV, a national certification
body, for conformity to global safety standards, including those of
Canada, US, and EU.

Safety Certifications
For information on safety certifications, see the Declaration of Conformity
(DoC). For a DoC, contact your local technical provider or distributor.

Electromagnetic Compatibility (EMC)

For information on electromagnetic compatibility, see the Declaration of
Conformity (DoC). For a DoC, contact your local technical provider or
distributor.

WARNING
Protection is impaired if used in a manner not specified by the
manufacturer.

Protecting Yourself from Biohazards

This section summarizes the established guidelines for handling laboratory
biohazards. The summary is based on the guidelines developed by the
National Institute of Health (NIH) and Centers for Disease Control (CDC),
the guidelines in CLSI Document M29-A3, Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline -
Third Edition. Wayne, PA: Clinical and Laboratory Standards Institute.
Use this summary for general information only. It is not intended to replace
or supplement your laboratory or hospital biohazard control procedures.

page 18 RAPIDLab 348EX Operator’s Guide

Safety Information

By definition, a biohazardous condition is a situation involving infectious

agents that are biological in nature, such as the hepatitis B virus (HBV), the
human immunodeficiency virus (HIV), 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
To prevent accidental contamination in a clinical laboratory, strictly adhere
to the following procedures:
• Wear gloves while servicing parts of the system that have contact with
body fluids such as 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
system 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.

RAPIDLab 348EX Operator’s Guide page 19

Safety Information

• Do not recap, purposely bend, cut, break, remove from disposable

syringes, or otherwise manipulate needles by hand. Needlestick
injuries may result.

References
1. Centers for Disease Control. Update: Universal precautions for
prevention of transmission of human immunodeficiency virus,
hepatitis B virus and other bloodborne pathogens in healthcare
settings. 1988. 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. Wayne, PA: Clinical and
Laboratory Standards Institute; 2005. CLSI Document M29-A3. [ISBN 1-
56238-567-4].
3. Federal Occupational Safety and Health Administration. Bloodborne
Pathogens Standard. 29 CFR 1910. 1030.

Operating Precautions
• The system is designed to be left connected to an AC power supply. To
prevent damage to the instrument, before powering off the system,
whether by the power switch or by disconnecting the power cord,
perform the procedures in Shutting Down the System, page 107. Do
not leave it switched off for long periods.
• Never turn the pump rotors counterclockwise. If the system detects a
bubble, move the sample forward until it is underneath all the sensors
and no air bubbles are beneath the sensors.
• Use Siemens collection devices, if available, as the heparin coating has
been specially formulated.
• Use only Siemens approved QC materials.
• When sampling from syringes, position the probe to obtain the most
representative sample. Do not allow the probe tip to touch the syringe
plunger. Obstructing the probe tip can cause sampling faults, and, in
extreme cases, calibration instability.
If you suspect the probe tip was obstructed during sampling, we
recommend cancelling the sample analysis and calibrating the system.
See Calibrating Your System, page 49.
• Do not release the measurement block catch unless the instrument has
been stopped using the STOP SYSTEM routine. See Stopping the
System, page 70.

page 20 RAPIDLab 348EX Operator’s Guide

Safety Information

• Carry out routine maintenance at the intervals stated in Section 7,

Maintenance.
• Ensure that the drip tray is always in place and is correctly connected.
• When working with dialysis fluid, do not measure the acidic
component of bicarbonate-based dialysis fluid.
• Handle all samples as if they contain pathogenic organisms. Always
wear gloves when handling samples and waste materials.
• Take care when opening ampules. Use ampule breakers to protect your
fingers.
• Make sure that before handling the component parts of the system
(such as the probe, sensors, measurement block, pump tubing and
waste bottle) you have used the Disinfect routine, see Section 7,
Maintenance. Always wear gloves when carrying out any maintenance
to the system.
• Siemens Conditioner contains 0.1M ammonium bifluoride (ammonium
hydrogen difluoride) which is toxic if swallowed and will cause burns if
it comes into contact with the skin. In case of contact with eyes rinse
immediately with plenty of water and seek expert medical advice.
Clean spillages immediately and wash with plenty of water.
• Ensure that the manufacturer's directions for use are followed when
using disinfectant.
• The system weighs approximately 10 kg (22 lb). Observe safe lifting
procedures.
• Do not move the system with the reagent and waste bottles in place.

Using and Replacing Reagents and Supplies

• Use only Siemens reagents and supplies with the system.
• Do not use reagents after the expiry date shown on the label. Do not
use 7.382 and 6.838 buffer for longer than 21 days after opening.
• Do not decant solutions from one bottle to another, as this can cause
contamination.
• Agitate the Buffer Pack daily, to incorporate any solution that may have
condensed on the inside surface of the bottles.
• It is advisable to dispose of the waste daily and add approximately
10 mL of disinfectant or sodium hypochlorite to the bottle.

RAPIDLab 348EX Operator’s Guide page 21

Safety Information

• When replacing the Buffer Pack or Wash bottle, always remove the
waste bottle and put the empty 7.3 Buffer or Wash bottle in its place.
Siemens recommends that you put approximately 10 mL of
disinfectant or sodium hypochlorite into the empty bottle before
placing it in position as the new waste bottle.

Handling Compressed Gas Cartridges

Compressed gas cartridges require careful handling. To prevent damage
and possible personal injury, observe the following precautions:
• Never drop cartridges, allow them to strike each other or subject them
to other strong shocks.
• Never tamper with the cartridge valves.
• Use these gases for the calibration of clinical and research
instrumentation only. (US Law prohibits dispensing these gases for
drug use).
• The contents are under pressure. Do not puncture cartridges.
• Do not use or store near heat or open flame.
• Do not expose cartridges to temperatures above 54°C (130°F) as this
may cause the contents to vent or explode.
• Never throw cartridges into fire or incinerators. Dispose of the
cartridges according to your laboratory protocol.

Protecting Yourself from the Barcode Reader Beam

• Never look directly at the beam of a hand-held barcode reader.
• 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

• Do not operate the system in the presence of flammable anesthetic
mixture with air, O2, or nitrous oxide because of the risk of explosion in
such an environment.
• The system uses a grounded external power cord for connection to a
grounded electrical outlet.The system has no internal user-replaceable
parts. Do not remove the back cover from the system.

page 22 RAPIDLab 348EX Operator’s Guide

2 Introduction

The RAPIDLab 348EX system is a benchtop system that analyzes whole

blood and dialysis fluids. It is intended for use by laboratory staff and
clinicians processing a low to moderate volume of samples (20–30) each
day.

Intended Use of the RAPIDLab 348EX System

The system is designed for the determination of pH, pCO2, pO2, Na+, K+,
Ca++ or Cl– and Hct in heparinized human whole blood samples. The
minimum sample volume is 50 μL.
The results appear on the touch screen display in pH or H+, mmHg or kPa
for pCO2 and pO2, mmol/L for Na+, K+, Ca++ or Cl–, and % for Hct.
The system also calculates the following parameters:
• Standard and actual bicarbonate (HCO3–std and HCO3–act)
• Total carbon dioxide content (ctCO2)
• Blood and extra-cellular fluid base excess (BE(B) and BE(ecf))
• Estimated oxygen saturation (O2SAT)
• Estimated oxygen content (O2CT)
• Arterial-alveolar oxygen tension difference (pO2(A–a)) and arterial-
alveolar oxygen tension ratio (pO2(a/A))
• Anion gap (AnGap)
• Estimated total hemoglobin (ctHb(est))
• Calcium ion concentration adjusted to pH 7.4 (Ca++(7.4))
• Arterial oxygen tension-inspired oxygen fraction ratio (pO2/FIO2)
The system is also designed for routine determination of pH, pCO2, Na+,
K+, and Ca++ in acetate- and bicarbonate-based dialysis fluids. When used
in dialysis fluid mode, the results are displayed on the touch screen in pH or
H+, mmHg or kPa for pCO2, and mmol/L for Na+, K+, and Ca++. In dialysis
fluid mode, the system calculates the following parameters: actual
bicarbonate (HCO3–act) and total carbon dioxide content (ctCO2).

RAPIDLab 348EX Operator’s Guide page 23

Introduction

Summary and Explanation

The RAPIDLab 348EX analyzer and reagents are semi-automated in vitro
diagnostic ( ) devices intended for professional use in Near Patient/
Point of Care or centralized laboratory locations. Information for
quantitative measurement of each analyte measured on the RAPIDLab
348EX Blood Gas System are described below.
Measurements of blood gases (pCO2, pO2) and blood pH are used to aid in
the diagnosis and treatment of acid-base disturbances.
Sodium, Potassium and Chloride measurements are used to aid in the
diagnosis and treatment of electrolyte imbalances.
Ionized Calcium measurements are used to aid in the diagnosis and
treatment of parathyroid disease, a variety of bone diseases, chronic renal
disease, and tetany.
Hematocrit measurements are used to aid in the diagnosis of anemia and
polycythemia.
The RAPIDLab 348EX Blood Gas System includes the following primary
components:
Buffer Pack contains two buffers. The 7.382 buffer provides the
calibration point for pH, electrolyte and hematocrit calibrations. The 6.838
buffer provides the slope point for 2-point pH and electrolyte calibrations.
Hct Slope reagent provides the slope point for 2-point Hct calibration.
Sensors available on the system are pH, Na+, K+, Ca++ or Cl-, pCO2, pO2,
reference, and Hct. The following sensors require fill solutions - pH, Na+,
K+, Ca++, Cl- and the reference sensor.
Wash reagent contains wash fluid which cleans the probe and sample
path after analysis.
After sample analysis is complete, the waste bottle collects reagents,
samples, and waste into the waste bottle.
Gas Cartridges are used for calibration. Gas 1 (cal) provides the calibration
point for 1- and 2-point pCO2 and pO2 calibrations. Gas 2 (slope) provides
the slope point for 2-point pCO2 and pO2 calibrations.

page 24 RAPIDLab 348EX Operator’s Guide

3 Handling Samples and Reagents

The requirements and procedures described here are based on techniques

appropriate for pH, blood gas, dialysis fluid analysis, and electrolyte
analysis.1
• Collecting Blood Samples, page 25
• Handling and Storing Samples, page 28
• Dialysis Fluid Sample Handling, page 30
• Reagents, page 30

Collecting Blood Samples

Use proper medical supervision when selecting a site from which to collect
blood samples, performing collection procedures, and documenting
sample handling. Use sterile technique at all times to avoid infecting the
puncture site.1 The medical person responsible must approve the specific
details of any collection.

BIOHAZARD
Handle all samples as if they contain pathogenic organisms. See Chapter 1,
Safety Information, for recommended precautions when working with
biohazardous materials.

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
might alter sample values and damage the system.

Note To prevent hemolysis and maintain sample integrity, use capillary

tubes that do not contain mixing beads.

RAPIDLab 348EX Operator’s Guide page 25

Handling Samples and Reagents

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—Second Edition; CLSI
Document C46-A2; (Vol. 29, No. 8); 2009.

CAUTION
• Interpret results from patients anesthetized with halothane or nitrous
oxide with care, as the pO2 values may be unreliable due to the
reduction of halothane or nitrous oxide by the pO2 sensor.2
• Avoid using sample collection devices containing EDTA, citrate,
oxalate and fluoride anticoagulants, as these anticoagulants have a
significant effect on blood pH, Na+, K+, Ca++, Cl– and Hct.
• Avoid hemolyzed samples, as hemolysis causes elevated K+ readings.
• Samples with elevated levels of salicylates, salicylate derivatives such
as ibuprofen, and bromide (Br–), can increase chloride readings, as
can samples contaminated with perchlorate (ClO4–), thiocyanate
(SCN–), iodide (I–) and nitrate (NO3–).
• Avoid using excessive levels of heparin anticoagulants, as they cause
calcium-heparin chelation and decrease Ca++ levels.
• Interpret Hct results from patients on cardiopulmonary support or
receiving autologous transfusion with care, as the Hct value can be
lowered in these cases.
• Large changes in protein can affect reported Hct values by 1–1.35%
per g/dL. High leukocyte counts in blood samples can also increase
reported Hct values.

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Handling Samples and Reagents

Sample Sources
The system 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 of the patient.
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 samples are routinely obtained from an
antecubital vein using vacuum tube collection
systems. Other sites can be used as necessary.
Reported venous oxygen saturation values must be
labeled as such to ensure correct interpretation of the
results.
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. Avoid
hemolysing the sample, because potassium levels are
falsely elevated in hemolyzed blood.

When correctly collected, arterial, venous, and capillary blood samples are
also suitable for electrolyte determinations.

Sample Collection Devices

Note Collect dialysis fluid samples, either acetate or bicarbonate based, in
sterile tubes or glass bottles.

RAPIDLab 348EX Operator’s Guide page 27

Handling Samples and Reagents

Syringes
• Use Siemens heparinized syringes or equivalent when collecting blood
samples.
• Ensure that the syringe is completely filled, as incomplete filling raises
the level of heparin with respect to the sample.
• To minimize room air contamination, a concern in pO2 determinations,
avoid drawing air into the sample.
• Immediately after drawing the sample, expel all air from the syringe,
cap it securely, and thoroughly mix the sample to minimize the
possibility of clot formation.

Capillary Tubes
• Use Siemens capillary tubes to collect capillary blood.
• The nominal volume is 95 μL, but a minimum of 50 μL can be
measured in micro sample mode.
• Ensure that the capillary tube is completely filled and the ends securely
capped.
• Mix the sample thoroughly to minimize the possibility of clot
formation.

CAUTION
If you use mixing beads, remove the beads prior to sampling to prevent
damaging the system.

Vacuum Tube Collection Systems

Vacuum tube systems containing lithium heparin can be used for venous
samples. Fill the tube completely and mix the samples by gentle inversion
to minimize the possibility of clot formation.

Handling and Storing Samples

The following conditions 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

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Handling Samples and Reagents

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, because the sample consumes oxygen
during storage. 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:
• Analyze the sample as soon as possible to minimize oxygen
consumption.
• Analyze blood collected for special studies, such as A-a O2 gradients, or
shunt studies, within 5 minutes of collection.
• Do not ice plastic syringes. Keep them at room temperature, so long as
the blood is analyzed within 30 minutes of collection.
• Oxygen and carbon dioxide 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.
• For blood gas measurements, if you anticipate a prolonged time delay
of more than 30 minutes before analysis, use glass syringes and store
them in ice water.
Note Do not use syringes stored in ice water for electrolyte
determinations, as ice water effects on diffusion in and out of the red
blood cells can cause unreliable potassium results. Storage in ice water
applies only to blood gas measurements.
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+ values. Analyze samples with elevated
white blood cell or reticulocyte counts immediately, because they
deteriorate more rapidly.
• 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, until it is homogeneous.
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.

RAPIDLab 348EX Operator’s Guide page 29

Handling Samples and Reagents

• 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.
Note Clot formation can block sample pathways.

Dialysis Fluid Sample Handling

Observe the following practices when handling dialysis fluid samples:
• Store dialysis fluid samples at 2–8°C prior to analysis.
• Do not measure dialysis fluid samples if they are outside the range
6.5–8.0 pH, as this affects the performance of the Na+ sensor.
• Measure dialysis fluid samples within 30 minutes of collection if pH and
pCO2 results are required.

CAUTION
Do not measure the acidic component of bicarbonate-based dialysis fluid.

Reagents
WARNING
Wear protective glasses, gloves, and coat when handling the reagents.

The reagents described in this section are for in vitro diagnostic use only.
Siemens cannot guarantee the performance of the system in any of the
following situations:
• Reagents other than those recommended are used.
• Expiry dates of reagents have been exceeded.
• Reagent change-by date has been exceeded.
• Reagents are not used or stored according to Siemens
recommendations.
• Standard laboratory practices are not followed.
• The procedures in this manual are not followed.

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Handling Samples and Reagents

Active Ingredients
Material Safety Data Sheets for the RAPIDLab 348EX system reagents are
supplied by your local distributor.

Intended Use of Reagents

Reagent Use
7.382 buffer Provides the calibration point for pH, electrolyte and
hematocrit calibrations. The 7.382 buffer is buffered
to a pH of 7.382 at 37°C and is NIST traceable.
6.838 buffer Provides the slope point for 2-point pH and electrolyte
calibrations. The 6.838 buffer is buffered to a pH of
6.838 at 37°C and is NIST traceable.
Wash Washes the probe and sample path.
Deproteinizer Removes protein buildup from the sample path.
Deproteinizing is part of regular preventive
maintenance for the system.
Conditioner Cleans and conditions the pH and sodium sensors.
Conditioning is part of regular preventive maintenance
for the system.
Hct slope Provides the slope point for 2-point Hct calibrations.
Hct slope solution uses NIST traceable salts.

Storage
• Store all reagents away from direct sunlight at 4–25°C.
• Discard 7.382 and 6.838 buffers 21 days after opening.
• Do not use reagents after the expiry date.
• Discard Deproteinizer, Conditioner, and Hct slope solution after a single
use.

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Handling Samples and Reagents

Shelf Life

RAPIDLab 348EX Component Shelf Life Guidelines

RAPIDLab Component: Shelf Life Temperature Acceptable light
in Months range conditions for storage
RAPIDLab Deproteinizer
Solution UDC 24 4°C–25°C away from light
Conditioner
Solution UDC 24 4°C–25°C away from light
RAPIDLab 348EX
Hematocrit Slope 18 4°C–25°C away from light
RAPIDLab 348EX
Cal Buffer 12 4°C–25°C away from light
RAPIDLab 348EX
Slope Buffer 12 4°C–25°C away from light
RAPIDLab 348EX
Wash 18 4°C–25°C away from light

Handling and Preparation

The following reagents require no preparation before use:
• 7.382 buffer
• 6.838 buffer
• Hct slope
• Wash
• Conditioner
Prepare Deproteinizer as directed by the instructions on the package.

page 32 RAPIDLab 348EX Operator’s Guide

4 System Operation

• Powering Up the RAPIDLab 348EX System, page 33

• Selecting Options and Entering Data, page 34
• Entering Your Operator ID and Password, page 35
• Menu Map, page 35
• Analyzing Syringe Samples, page 36
• Analyzing Capillary Samples, page 38
• Interpreting Results, Syringe and Capillary Samples, page 40
• Analyzing Dialysis Fluid Samples, page 41
• Measuring a Micro Sample, page 42
• Measuring a Short Sample or a Sample with a Bubble, page 43
• Recalling Sample Data, page 45
• Standby Mode, page 47

Materials Provided
RAPIDLab 348EX Analyzer

Special Materials Required (Not Provided)

• Sensors
• Reagents
• Gas Cartridges

Powering Up the RAPIDLab 348EX System

Perform these steps if the system is not already turned on.
1. Connect the power cord to an appropriate power outlet.
2. Press the Power switch to turn on the system.
The system begins the power-up sequence and displays Not Ready until
it is ready to function.
The system performs a number of internal tests, then displays a
Warming Up message.

RAPIDLab 348EX Operator’s Guide page 33

System Operation

Note Pressing the touch screen for 5 seconds while the first Warming
Up screen displays causes the screen calibration feature to appear. This
lets you recover the screen if it requires calibration before use. See
Calibrating the Touch Screen, page 54.

What You Can Do during Warmup

While the system is warming up, you can perform the following steps.
1. Prime the system to remove bubbles from the calibrant lines by
selecting Settings > Maintenance > Prime.
If necessary, repeat the routine to thoroughly prime the system.
2. Condition the sensors by selecting Settings > Maintenance >
Condition.
3. Initiate a 2-point calibration by selecting Settings > Maintenance >
Calibration > Full 2 Point.
The data from this calibration is not used.

When the System Reaches Operating Temperature

When the system reaches operating temperature, it automatically carries
out 2 full 2-point calibrations, 10 minutes apart.
1. Wait for the calibrations to complete
2. When the system displays the Ready screen, select Ready > QC.
3. Perform the appropriate quality control procedures.
See Section 6, Quality Control.

Selecting Options and Entering Data

Tap the screen lightly in a selection area or button to select an option or to
navigate in a list of items:
• To choose an option from a list, select the corresponding button on the
screen.
• To enter data, use the onscreen keypad or the barcode reader.
• Select Enter to save that data.
• To return to the Ready screen, select Back to step back through the
screens.

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System Operation

• To delete the last character in the currently highlighted line, select C on

the onscreen numeric keypad.

CAUTION
Do not use a stylus or other hard object to select items on the touch
screen. Doing so might damage the screen.

Entering Your Operator ID and Password

Entering Your Operator ID
If you configure the system to require an Operator ID, the system prompts
you to enter your operator ID when you lift the probe and does not allow
sample or QC analysis to continue until you have entered your ID. See
Section 10, System Installation and Configuration, for details on
configuring this requirement.
1. Enter from 1–16 digits for an operator ID.
Use the hyphen to insert dashes.
2. To continue with sample analysis, select Enter.
You can also use the barcode reader to enter the operator ID.
Your operator ID is printed on the sample or QC report.

Entering Your Password

Depending on the security options selected in Setup, the system might
prompt you to enter your password before performing some tasks. If
prompted for your password, perform the following steps:
1. At the prompt, enter your password.
If you have an alphanumeric password, use the barcode scanner.
2. Select Enter.

Menu Map
The touch screen displays a series of menus and display screens that let
you navigate through the system functions, select and perform specific
actions, and display results. See Appendix A, Menu Map for a list of the
principal menus. Each of these menus leads to a series of submenus
relevant to your selections.

RAPIDLab 348EX Operator’s Guide page 35

System Operation

Analyzing Syringe Samples

BIOHAZARD
Wear personal protective equipment. Use universal precautions. See
Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

1. Observe all rules and guidelines in Collecting Blood Samples‚ page 25.
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. Select Ready > Syringe.
3. Lift the probe lever to the second position (labeled 3, in Figure 1.)

Figure 1: Probe Lever Positions

1. Closed position
2. Sampling position for ampules and other open-top containers
3. Sampling position for syringes and capillaries

Note If you have pushed the probe cover up to the first position, which
is normally used for sampling from ampules and open-top containers,
the system displays a message asking you to confirm the sample type.
4. If required, enter your Operator ID (1–16 digits).
5. Wait for the screen to direct you to present the sample.
To cancel this operation, simply close the probe.
6. Slide the syringe sample onto the probe and gently push the probe
sleeve back.

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System Operation

7. Wait for the system to beep, indicating that the probe sleeve is in the
correct position, then select Measure.
Try to position the probe to obtain the most representative sample.
8. Hold the sample in place until the system beeps a second time, and a
Sample Complete message displays.
9. Remove the syringe and close the probe.
The system processes the sample, displays a Moving Sample - Please
wait message, then displays test results on 1 or 2 Measuring screens.
All measured analytes are displayed. Any sensors unavailable for
testing appear without numeric values.

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.

10. View the results.

Entering Patient Data

1. To enter patient data, on the Measuring screen (which you can reach in
a variety of ways), select Enter Patient Data.
Note The Enter Patient Data screen times out and returns to the
Measuring screen after 45 seconds of inactivity.
2. Navigate to the field you want to change.
3. Using the onscreen keypad or the barcode reader, enter the data in the
highlighted field:
• Operator ID and Patient ID: 1–16 digits. Use the hyphen key to
insert dashes.
• Patient temperature: 10.0–43.9°C
• ctHb: 2.0–25.0 g/dL (20–250 g/L or 1.2–15.5 mmol/L)
• FIO2: 15.0–100.0%
The system uses the values entered for patient temperature, ctHb, and
FIO2 when calculating the results.
4. Select Enter to save the data.

RAPIDLab 348EX Operator’s Guide page 37

System Operation

Note If you do not enter patient data, the system uses normal (default)
temperature (37°C) and FIO2 (20.9%) values in the calculations. If Hct
was measured, the calculated ctHb value is used; otherwise, the system
uses 15 g/dL (150 g/L, 9.3 mmol/L). However, the system reports:
• O2CT only if ctHb is entered or ctHb(est) is available.
• pO2(A-a), pO2(a/A), and pO2/FIO2 only if FIO2 is entered.
You can correct results for patient temperature, ctHb, and FIO2 after
measurement. See Recalling Sample Data, page 45.
Depending on the number of parameters you selected to be measured,
the results are on 1 or 2 screens. Measurement is complete when the
equals sign on the display stops flashing.
The screen displays all measured parameters and up to 8 calculated
parameters. If you select more than 8 calculated parameters, only the
first 8 appear on the screen, but all selected parameters are printed
and, if an LIS connection is configured, sent to the LIS.
While displaying and printing the results, the system washes the probe
and sample path. When the wash has finished, the measurement block
light goes off.
The system automatically returns to the Ready screen if it is inactive for
30 seconds.

Analyzing Capillary Samples

BIOHAZARD
Use universal precautions. See Section 1, Safety Information, for
recommended precautions when working with biohazardous materials.

1. Select Ready > Capillary.

2. Lift the probe lever to the second position.
This is the same position as for syringe samples.
3. If required, enter from 1–16 digits for your Operator ID.
4. The measurement block light comes on and the Probe Open screen
displays.
5. Remove the caps from the end of the capillary and carefully fit a
capillary adaptor.
6. Slide the adapter onto the probe, then select Measure.
The system beeps and, when sampling is complete, displays the
Sampling screen.

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System Operation

Note If you have pushed the probe cover up to the first position, which
is normally used for sampling from ampules and open-top containers,
the system displays a message asking you to confirm the sample type.
7. Hold the capillary in place.
The system beeps and, when sampling is complete, displays the
Sampling complete screen.
8. Remove the capillary and adapter and close the probe.
The Moving sample screen displays while the sample is moving, then
the Measuring screen displays.
If a bubble or short sample is detected, the system alerts you to this
condition. See Measuring a Short Sample or a Sample with a Bubble,
page 43, for details.
The Measuring screen dynamically updates the numeric data as the test
proceeds. Any sensors unavailable for testing appear without numeric
values. The equals sign flashes until the result for that parameter is
complete.
9. To enter patient data, select Enter Patient Data on the Measuring
screen.
The Enter Patient Data screen appears, along with the onscreen
keypad.
Note The Enter Patient Data screen times out and returns to the
Measuring screen after 45 seconds of inactivity.
10. On the Enter Patient Data screen, enter the data in the highlighted
fields:
• Operator ID and Patient ID: 1–16 digits. Use the hyphen key to
insert dashes.
• Patient temperature: 10.0–43.9°C
• ctHb: 2.0–25.0 g/dL (20–250 g/L or 1.2–15.5 mmol/L)
• FIO2: 15.0–100.0%.
Note ctHb and FIO2 do not apply in dialysis fluid analysis.
The system uses the values entered for patient temperature, ctHb, and
FIO2 when calculating the results.

RAPIDLab 348EX Operator’s Guide page 39

System Operation

Note If you do not enter patient data, the system uses normal (default)
temperature (37°C) and FIO2 (20.9%) values in the calculations. If Hct
was measured, the calculated ctHb value is used; otherwise, the system
uses 15 g/dL (150 g/L, 9.3 mmol/L). However, the system reports:
• O2CT only if ctHb is entered or ctHb(est) is available, and
• pO2(A-a), pO2(a/A), and pO2/FIO2 only if FIO2 is entered.
You can correct results for patient temperature, ctHb, and FIO2 after
measurement. See Recalling Sample Data, page 45.
11. Select Enter when you are done.
• If the system is still measuring, the Measuring screen appears.
• If measuring is completed, the Results screen appears.
Note If the system is inactive for about 30 seconds, it returns to the
Ready screen.
12. To see the calculated parameters, select the down arrow to display the
second Results screen.
Up to 8 parameters appear on this screen, but all the selected
parameters are printed.

Interpreting Results, Syringe and Capillary Samples

If the measured values are outside the reference ranges, an arrow indicates
whether they are above or below the range. Results display on two
consecutive screens. Calculated parameters, if selected, appear on the
second Results screen. See Section 10, System Installation and
Configuration, for details on reference ranges and calculated parameters.
To see this second screen, select the down arrow.
Note Hct determinations depend on electrolyte concentrations (that is,
conductivity). The system corrects for high/low levels of the electrolytes
Na+ and K+ that would alter conductivity, and hence affect Hct
measurement. The system flags the Hct value with u (uncorrected) during
measurement. The Hct value is updated when the electrolyte values are
known.
If the Na+ value is not available at measurement endpoint, the Hct result is
flagged as uncorrected on the display and on the printout.
While displaying and printing the results, the system washes the probe and
sample path. When the wash has finished, the measurement block light
goes off.

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System Operation

Analyzing Dialysis Fluid Samples

1. On the Ready screen, select Dialysis Fluid (DF).
2. Lift the probe to the first position.
3. If required, enter from 1–16 digits for your Operator ID.
4. The Probe Open screen displays and the measurement block light
comes on.
The screen displays the instruction Present Sample.
5. Using the edge of the sample container, gently push the probe sleeve
back, immersing the probe in the sample.
The system beeps and starts sampling when the probe sleeve is in the
correct position.

CAUTION
Do not allow the probe tip to touch the bottom of the sample container.

6. Hold the sample in place.

The system displays a Sampling message, then beeps when sampling is
complete.
7. Remove the sample and close the probe.
The Moving sample screen displays while the sample is moving, then
the Measuring screen displays.
If it detects a bubble or short sample, the system alerts you to this
condition. See Measuring a Short Sample or a Sample with a Bubble,
page 43.
The Measuring screen dynamically updates the numeric data as the test
proceeds. Any sensors unavailable for testing appear without numeric
values. The equals sign flashes until the result for that electrolyte is
complete.
8. To enter patient data, select Enter Patient Data on the Measuring
screen.
9. On the Enter Patient Data screen, enter the data in the highlighted
fields:
• Operator ID and Patient ID: 1–16 digits. Use the hyphen key to
insert dashes.
• Patient temperature: 10.0–43.9°C
After 45 seconds of inactivity, the Enter Patient Data screen times out
and returns to the Measuring screen.

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System Operation

Note If you do not enter patient data, the system uses normal (default)
temperature (37°C) value in the calculations.
If necessary, you can correct results for patient temperature after
measurement. See Recalling Sample Data, page 45.
10. When you are done, select Enter to save the results.
11. One of the following screens appears:
• If the system is still measuring, the Measuring screen appears.
• If measuring is completed, the Results screen appears.
Note If the system is inactive for about 30 seconds, it returns to the
Ready screen.
12. To see the calculated parameters, select the down arrow to display the
second Results screen.
Up to 8 parameters appear on this screen, but all the selected
parameters are printed. Calculated parameters do not apply for dialysis
fluid analysis.

Measuring a Micro Sample

If the system detects a sample that is less than 95 μL, it first determines
whether it has sufficient sample (minimum 50 μL) to perform the test in
micro sample mode.
If the system could not gather sufficient sample material, the message
Bubble in Sample or Short Sample displays. See Measuring a Short Sample
or a Sample with a Bubble, page 43 for details.
If the system detects enough sample material for a micro sample, it
displays the Micro Sample screen with the message Micro Sample in
Progress for about 8 seconds.
To cancel the test, select Cancel during this interval. The system then
enters the wash cycle to flush the sample out of the measurement block.
When the wash cycle completes, the display returns to the Ready screen.
If you do not select Cancel, the system positions the sample under the first
three sensors and measures it. The Measuring screen displays, and the
system automatically measures the sample in micro sample mode.
After the first three sensors process the sample, the system displays Please
wait, and the sample then moves on to the remaining sensors and is
measured.
When the measurement is complete the system displays the results as
usual, and the printout shows Micro Sample.

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System Operation

If the system cannot position the sample for the second part of the
measurement, the sample is flushed out of the measurement block and the
display returns to the Ready screen. The successfully measured parameters
are reported.
Note If you select Enter Patient Data to enter patient data when the
Cancel message is displayed, you can no longer cancel the measurement.

Measuring a Short Sample or a Sample with a Bubble

If the system detects a short sample or a bubbles in a sample, it offers you
the following choices:
• Manually reposition the sample so no air bubbles are under the
sensors, then continue with the analysis.
• Flush the sample out of the measurement block and repeat the
analysis.
The system beeps and displays either the Short sample screen or the
Bubble in sample screen, as appropriate.
This message displays for 1 minute. If you take no action, the system
flushes the sample out of the measurement block.

Continuing with the Short or Bubble Sample Analysis

When the Short Sample or Bubble in Sample screen displays the message
Reposition the sample and select Measure to measure, perform the
following steps:
1. To measure the sample, lift the front cover and look at the
measurement block.

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System Operation

2. Turn the sample pump rotor (the sample pump is the left pump) in the
direction indicated (Figure 2), so that the sample is repositioned
directly beneath the sensors for which results are required.

Figure 2: Repositioning the Samples

CAUTION
Do not move sample pump rotor counterclockwise, as KCl from the
reference sensor might contaminate the sample.

CAUTION Ensure that the sample is repositioned directly beneath the

sensors for which results are required. For example, for pO2 and pCO2
results, the sample must be positioned under the pO2 and pCO2 sensor
with no air bubbles present. For electrolyte results, the sample must be
positioned under the electrolyte and reference sensors with no air
bubbles present. Air bubbles present under one of the sensors as a result
of incorrect sample repositioning may lead to erroneous results.

3. When you are satisfied that the sample is correctly repositioned select
Measure.
The sample analysis continues. No further Short sample or Bubble in
sample messages display, although the sample is flagged on the
printout.
Note The system beeps twice, every 3 seconds, until you take some
action.

Cancelling the Sample Analysis

Select Cancel to end the sample analysis before it finishes.

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System Operation

The system flushes the sample out of the measurement block and the
display returns to the Ready screen.

Recalling Sample Data

The system retains the data for the last 250 samples measured. The Data
Recall menu lets you perform the following functions:
• Recall data for each sample.
• Enter or change patient data for each sample.
• Print results for each sample.
1. Select Ready > Settings > Data Recall > Sample Data.
2. Select one of the user actions or Back, or scroll through the list of
results.
In the initial display, the first result is highlighted on the screen.
3. Select an item that you want to print or for which you want to view all
the results.
4. Select Back to return to the Data Recall screen.

Viewing Recalled Sample Data

The results list shows the data stored in the system’s memory for the last
sample measured. It includes the Sample identification data: analysis time
and date, sample number, patient ID, and operator ID (if entered).
1. To view the recalled data, select the result that you want to view by
performing one of the following actions:
• Use the scroll bar on the results list to locate a particular result.
• Select the up and down arrows at the top and bottom of the scroll
bar to move the results up or down.
2. Highlight a particular result in the list by selecting it.
3. Select View Result to display the full set of results for the highlighted
item.
Note The system reports O2CT only when ctHb was entered or
ctHb(est) is available, reports and pO2(A-a), pO2(a/A), and pO2/FIO2
only when FIO2 was entered.
The results appear on 1 or 2 screens, depending on the number of
parameters included for that sample. The first results screen shows up
to 8 numeric values.

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System Operation

4. To navigate between the first and second screens, select the up or

down arrows.
If no screen 2 parameters exist for this sample, pressing the down
arrow on the first results screen displays the message No parameters
selected.
5. Select Back to return to the Sample Data screen or select the up arrow
to return to the first results screen.

Entering Patient Data for a Recalled Sample

1. To enter or change the patient data for the highlighted result, select
Enter Patient Data on the Data Recall .... Sample Data screen.
Note The Enter Patient Data screen times out and returns to the
Measuring screen after 45 seconds of inactivity.
2. Select a field for which you want to enter or change the data.
The data entry area for the selected field is highlighted. No fields are
selected by default.
3. Enter the data in the highlighted fields on the Enter Patient Data
screen.
On the onscreen keypad, select C to delete the last character in the
currently highlighted line. Use the up and down arrow keys to navigate
between screens.
You can correct results for patient temperature, ctHb, and FIO2 after
measurement, within the following ranges:
• Operator ID and Patient ID: 1–16 digits. Use the hyphen key to
insert dashes.
• Patient temperature: 10.0–43.9°C
• ctHb: 2.0–25.0 g/dL (20–250 g/L or 1.2–15.5 mmol/L)
• FIO2: 15.0–100.0%
Note If you attempt to enter data outside the reasonable ranges, the
system rejects the entered value. Selecting another data entry line or
selecting Enter causes the system to beep 3 times and either blank the
field with the unacceptable data or revert to the previous reasonable
data.
If you do not enter patient data, the system retains the values from the
recalled record.
4. When you are done, select Enter to save the results.

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System Operation

Note If the system is inactive for about 30 seconds, it returns to the

Data Recall screen without saving your entries.

Printing Recalled Results

To print the highlighted result, on the Data Recall .... Sample Data screen,
select Print Result.
The Print Result screen displays, with a Please wait message.
If a printer error occurs, such as the printer being out of paper, an error
message screen appears briefly before the Print Result screen.
The printout shows the date and time the sample was analyzed, not the
time of recall.
Note The system prints only 1 copy, regardless of copy number selected in
Printer Options.
After printing the results, the system returns to the Data Recall .... Sample
Data screen.

Standby Mode
Standby mode conserves reagents. The sensors are kept wet and the pump
tubes are moved from time to time to keep them in good condition. The
system does not calibrate while in standby mode, but it automatically
calibrates as required when restarted, before allowing sample
measurements.

Entering Standby Mode

1. Select Ready > Settings > Standby.

Restarting from Standby Mode

1. To immediately restart the system, on the Standby screen, select
Restart.
The system returns to the Main Menu screen.
2. To set a time when the system automatically restarts, select Set auto
restart time.
The system displays the Set auto restart time screen.
3. In the Auto restart at field, specify a restart time in 24-hour, hh:mm
format.
The system checks your entry for validity and automatically restarts at
that time.

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System Operation

page 48 RAPIDLab 348EX Operator’s Guide

5 Calibrating Your System

• Selecting Calibration Method and Entering Gas Values, page 49

• Calibrating the Barometer, page 51
• Recalling and Printing Calibration Data, page 52
• Requesting Additional Calibrations, page 52
• Checking Hct Slope, page 53
• Diagnosing and Fixing Causes of Calibration Failures, page 53

Selecting Calibration Method and Entering Gas Values

1. Select Ready > Settings > Operating Setup > Calibration.
2. Select Timing or Gas Values and proceed to the next sections to set up
the calibration, as follows:
Note The system calibrates automatically, as necessary, based on the
methods and timing mode that you configure.

Choosing the Calibration Timing Mode

Select fixed or flexible calibration timing, as described in the following
table:

Fixed Time Flexible Time

Interval between 30 or 60 minutes Maximum interval: 30 or
calibrations 60 minutes

Description The system calibrates The system calibrates

automatically at the automatically as
interval you specify: 30 required and calculates
or 60 minutes. the time between
calibrations to optimize
performance.

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Calibrating Your System

Fixed Time Flexible Time

Result • A 1-point • The time between
calibration is carried 1-point calibrations
out at every is between 10
interval. minutes and the
• A full 2-point maximum time
calibration (not Hct) interval selected.
is carried out at • A full 2-point
every fourth calibration (not Hct)
interval. is carried out at
• Hct slope check is every fourth
prompted at least interval.
every 25 days. • Hct slope check is
prompted at least
every 25 days.
Example If interval = 30 minutes, If interval = 60 minutes,
the system automatically the system automatically
carries out a 1-point carries out a 1-point
calibration every 30 calibration at least once
minutes, and a 2-point every 60 minutes and a
calibration every 2 2-point calibration at
hours. least every 4 hours.

Automatic Calibrations, Independent of Timing Mode

In both fixed and flexible time methods, the system automatically
calibrates after certain maintenance routines; for example, the Disinfect,
Deproteinize, and Condition routines. It also calibrates if the measurement
block door has been opened and closed or if a sampling fault occurs; for
example, Sample not detected.

Selecting Calibration Timing

1. Select Calibration > Timing.
2. On the Timing screen, select the calibration timing method, Fixed or
Flexible (default).
For an explanation of fixed and flexible time modes, see Calibration
Overview, page 163.
3. On the same screen, select the calibration interval, 30 minutes
(default, recommended) or 60 minutes.
4. Select Back to return to the Calibration screen.

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Calibrating Your System

Calibrating Gas Values for the pCO₂ and pO₂ Sensors

Gas 1 provides the calibration point for 1- and 2-point pCO2 and pO2
calibrations. Gas 2 provides the slope point for 2-point pCO2 and pO2
calibrations.

CAUTION
When handling compressed gas cylinders, be sure to observe the safety
precautions described in Handling Compressed Gas Cartridges, page 22.

1. Select Calibration > Gas Values.

2. Select the field for which you want to enter a gas value.

CAUTION
Do not change the default settings for gas values when using the
Siemens gas pack.

3. Enter the appropriate value into the highlighted field.

The maximum ranges available for gas values are:

Cal Slope
CO2 4.00–6.00% 8.00–12.00%
O2 10.00–14.00% 0.00–2.00%

Default settings:

Method:
time flexible
interval 30 minutes

Gas values:
cal 5% CO2 12% O2
slope 10% CO2 0% O2

Calibrating the Barometer

1. Select Ready > Settings > Calibration > Barometer.
2. Read the atmospheric pressure from an external barometer in the lab.
3. Enter the atmospheric pressure reading in mmHg.
The adjustment range for the barometer is the displayed value
±20 mmHg.

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Calibrating Your System

Recalling and Printing Calibration Data

The system maintains a calibration summary for all calibrations within a
24-hour period. You can print a calibration summary either automatically
or manually.

Automatically Printing a Calibration Summary

Configure the printer setup options to print the summary every day at the
end of the first calibration after 6 AM. See Setting Printer Options,
page 151.

Manually Printing a Calibration Summary

1. Select Ready > Settings > Data Recall > Print Cal Summary.
2. Wait for the printing to complete.
3. Select Back to return to the Main Menu screen.

Requesting Additional Calibrations

1. Select Ready > Settings > Calibration.
2. On the Calibration screen, select the type of calibration you want to
perform.
Note The system does not allow a partial calibration if a full calibration
is due. For example, if you select Full 1 Point when a 2-point calibration
is due, the system displays Full 2 point required.
The header text updates dynamically to inform you which part of the
calibration cycle is being carried out, and the parameters updating in
real time.
If the calibration passes, the system returns to the previous screen. A
successful, user-requested calibration resets the automatic calibration
timer.
3. If you select Cancel to end or interrupt a running calibration, or if the
calibration fails, the system displays the Calibration Failed/Cancelled
screen. The system enters a wash cycle and then returns to the
previous screen.
You can cancel a calibration to run an urgent sample. However, you
can postpone the same calibration only twice, after which that
calibration has priority. If you chose to interrupt a calibration, it is ready
to run a sample in less than 40 seconds.

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Calibrating Your System

Note Raising the probe during the 1-minute countdown to calibration

delays the calibration indefinitely.
See Diagnosing and Fixing Causes of Calibration Failures, page 53.

Checking Hct Slope

Note The system automatically carries out 1-point calibrations on the Hct
sensor and prompts you for a slope measurement via the Action List (see
Using the Action List to Prompt for Maintenance, page 63).
1. Select Ready > Settings > Calibration > Hct Slope.
2. Following the instructions on the screen, lift the probe to the first
position.

WARNING
Open ampules carefully. Use ampule breakers to protect your fingers.

3. When the measurement block light comes on, present the Hct slope
solution to the probe and gently push the probe sleeve back.
The system beeps when the probe sleeve is in the correct position and
starts sampling.
4. Hold the Hct slope solution in place until prompted to remove it.
5. Close the probe.
The system positions the Hct slope solution.
The system shows the Hct slope result and the confirms the slope
measurement is successful.
Note If Hct slope is not measured within 24 hours of the Action List
prompt, all printouts are flagged as Hct slope overdue.

Diagnosing and Fixing Causes of Calibration Failures

1. To print the calibration summary to see possible further details of the
problem, select Ready > Settings > Data Recall > Print Cal Summary.
2. Review the calibration summary for the following indicators:

Indicator Calibration or Slope Condition

↑,↓ Drift
* No endpoint
! Outside range

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Calibrating Your System

Note Calibration problems might also be caused by fluidics failures or

by hydraulic problems. These conditions do not appear on the
calibration summary.
See Calibration Failures, page 112 for detailed descriptions of possible
causes and corrective actions.

Calibrating the Touch Screen

1. Select Ready > Settings > Maintenance> Screen Calibration.
2. Select the Touch Button icon in the top, left corner of the screen.
That icon and label disappear, and a new icon Touch Button appears.
3. Select the Touch Button icon in the lower, right corner of the screen.
The touch screen calibrates and returns to the Operating Setup screen.

page 54 RAPIDLab 348EX Operator’s Guide

6 Quality Control

• Handling QC Samples, page 55

• Default QC Operating Setup, page 56
• Changing the Default QC Operating Setup, page 56
• Analyzing QC Samples, page 56
• Recalling and Printing QC Data, page 57
Siemens recommends that you set up a Quality Control (QC) program to
monitor system and operator performance.4, 5 Because the needs of each
laboratory are different, because of patient sample volume, the number of
hours worked, and statutory regulations, this guide makes no attempt to
formulate a rigid program. Follow your local regulatory guidelines to
establish a QC program.
Siemens recommends the use of Siemens-approved QC materials. If you
report your results to a quality control statistical program, be sure to
include the name of the instrument: Siemens RAPIDLab 348EX system.

Handling QC Samples
1. Follow proper QC sample handling procedures to avoid significant
errors in QC measurements.
Such errors might be caused by any of the following issues:
• Improper storage and temperature equilibration of the QC sample
• Improper mixing of the QC sample
• Contamination of the QC sample by room air
2. Always carefully follow the manufacturer's instructions for use,
especially regarding the temperature of the QC material before
sampling.
3. Mix the QC material thoroughly, and once the ampule is opened,
sample the QC material immediately.
4. Do not re-use an opened ampule.
5. Position the probe near the bottom of the ampule to obtain a
representative sample.

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Quality Control

Default QC Operating Setup

The default (factory set) QC options and values are as follows:

Element Value
pH 6.001–8.000 (10.0–997.7 nmol/L H+)
pCO2 5.0–250.0 mmHg (0.67–33.33 kPa)
pO2 0.0–749.0 mmHg (0.00–99.86 kPa)
Na+ 80–200 mmol/L
+
K 0.50–9.99 mmol/L
Ca++ 0.20–5.00 mmol/L
Cl– 40–160 mmol/L
Hct 12–75%
QC prompts not set

Changing the Default QC Operating Setup

For information about changing the default QC setup, including setting QC
prompts, see QC Ranges Setup, page 149.
Note Changing the QC setup clears existing results.

Analyzing QC Samples
If QC Prompts have been set, the system prompts you via the Action List to
analyze a QC sample. You can also run QC samples at any time from the
Ready screen.
1. Select Ready > QC.
2. Lift the probe lever to the first position.
The measurement block light comes on and the touch screen displays
the Probe open screen.

CAUTION
Open ampules carefully.
Use ampule breakers to protect your fingers.

3. Present the QC sample to the probe and gently push the probe sleeve
back.
The system beeps and the screen displays the Sampling message when
the probe sleeve is in the correct position and starts sampling.

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Quality Control

4. Hold the sample in place.

The system beeps and the screen displays the Sampling complete
message when sampling is complete.
5. Remove the sample and close the probe.
The touch screen displays the Measuring screen, overlaid with the
Select QC Level dialog box.
6. On the Select QC Level screen, select Level 1, Level 2, Level 3, Hct
Level A, Hct Level B, or Level X.
This ensures that the result is compared to the appropriate QC
reference range, assigned to the appropriate QC file, and reported
correctly on the printer and DMS systems. If you do not select a QC
level, the system assumes Level X, which has no range checking.
7. When the measurement is complete, the system displays the results for
the appropriate QC Level on 2 successive screens.
Note If the measured values are outside the configured QC ranges, an
arrow indicates whether they are above ( ↑ ) or below ( ↓ ) the range.
While the results are displayed and printed, the system washes the probe
and sample path.
When the wash has finished, the measurement block light goes off and the
system returns to the Ready screen.
Note If you have set QC Prompts (see QC Prompts Setup, page 150),
analyzing a QC sample clears the Action List prompt. If more than one QC
prompt has become due, all printouts are flagged as QC overdue.

Recalling and Printing QC Data

The system retains the data for the last 90 QC samples measured for each
QC level. The system calculates statistics for QC levels 1, 2, and 3, and for
Hct levels A and B.
QC Level X has no statistical data, as that level has no range checking. If no
data is available for a selected level, the system briefly displays the No Data
Available screen, then returns to the QC Data screen.

Recalling, Viewing, and Printing a QC Result

1. Select Ready > Settings > Data Recall > QC Data.

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Quality Control

2. Select a QC or Hct level to view the statistics for that level.

The system displays a screen with a scrolling list of the QC
identification data, analysis time and date, QC number, and QC lot for
the last QC sample measured.
3. Scroll through the displayed stored results for that level until the
identification data for the QC sample you want to recall is visible.
• Use the scroll bar to scroll through the entire list.
• Use the up and down arrows at each end of the scroll bar to move
the list.
4. Select the result that you want to highlight for further action.
5. Select View Result to display the full results QC record for the
highlighted result.
6. Select Move Result to move the highlighted result to another QC level.
For example, you might do this if the result was wrongly assigned to a
level during measurement. Moving a result to Level X excludes the data
from any statistics.
7. On the Select QC Level screen, select the QC level memory location to
which to move the result, or select Cancel to exit without moving the
result.
After the move, or after timing out, the system returns to the previous
screen. If no further results remain in the QC levels memory from
which this screen was accessed, then selecting any of the QC level
buttons returns the system to the QC Data screen.
8. To print the results, select Print Result.
The printout shows the date and time the QC sample was analyzed, not
the time of recall.
When printing is done, the system returns to the previous screen.
9. Select Back to return to the QC Data screen.

Printing a QC Statistical Report

To print all the statistics for all QC levels, select Ready > Settings > Data
Recall > QC Data > Print Statistics.
The printed statistics are number, mean, SD, and CV% for QC level 1, 2,
and 3, and Hct levels A and B.
The system displays Please wait while it calculates the statistics before
printing. After printing, the system returns to the QC Data screen.

page 58 RAPIDLab 348EX Operator’s Guide

7 Maintenance

To ensure reliable, trouble-free performance, diligently perform these

required regular preventive maintenance routines.
• Preparations, page 60
• Accessing Maintenance Functions, page 60
• Daily Maintenance, page 60
• Weekly Maintenance, page 61
• Every-Other-Week Maintenance (or as Prompted via the Action List),
page 62
• Quarterly Maintenance, page 63
• Six-month Maintenance, page 63
• Using the Action List to Prompt for Maintenance, page 63
• Emptying the Waste Bottle, page 64
• Checking the Reagents, page 65
• Deproteinizing the Sensors, page 67
• Conditioning the Sensors, page 68
• Disinfectants to Use with the Disinfect Routine, page 69
• Using the Disinfect Routine, page 69
• Stopping the System, page 70
• Using the Prime Routine, page 71
• Changing the Gas Cartridges, page 72
• Checking the Gas Flow Rate, page 74
• Changing the Pump Tubing and Cleaning and Lubricating the Rollers,
page 75
• Refilling or Replacing the Measurement Sensors, page 80
• Replacing the Reference Sensor Cassette or Inner Electrode, page 83
• Replacing the Bottle Tubing, page 87
• Cleaning or Replacing the Drip Tray, page 88
• Replacing the Printer Paper, page 90
• Replacing the Probe and Tubing and Probe Housing, page 92
• Replacing the Pre-heater Tube, page 98
• Clearing Blockages, page 101
• Replacing Fuses, page 105

RAPIDLab 348EX Operator’s Guide page 59

Maintenance

Note The maintenance frequency is based on analyzing 20–30 samples

per day. Increase the maintenance frequency if your laboratory analyzes
more than 30 samples per day.

Preparations
1. Use the Disinfect routine before carrying out the following
maintenance routines. See Disinfectants to Use with the Disinfect
Routine, page 69:
• Replacing the pump tubing, cleaning and lubricating the rollers.
• Replacing the reference sensor cassette.
• Filling/replacing the pH, Na+, K+, Ca++, or Cl– sensor.
• Replacing the pCO2 and pO2 sensors.
• Replacing the Hct sensor.
• Replacing the probe and tubing, probe housing, and probe
protector.
• Replacing the pre-heater tube.
2. Before performing maintenance procedures, suspend the instrument
functions using the Stop System routine, page 70.
If you are carrying out maintenance via the Action List (see Using the
Action List to Prompt for Maintenance, page 63), the RAPIDLab 348EX
system automatically suspends instrument functions.
3. When replacing the pump tubing and bottle tubing, drain the system.
See Using the Prime Routine, page 71.
The system logs maintenance tasks, including the Deproteinize, Condition,
Prime, Disinfect, and Stop System routines on the printout. The printout
also shows if the electrode block door was opened during a calibration or
during sample or QC measurements, or if the power was turned off and on.

Accessing Maintenance Functions

1. Select Ready > Settings > Maintenance.
2. Select the function you want to perform.

Daily Maintenance
Equipment:
• Buffer Pack, as required
• Wash Pack, as required

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Maintenance

• 10% v/v bleach

• Clean tissues
1. Check levels of reagents and replace if necessary. See Checking the
Reagents, page 65.
With typical use, the reagents need replacing every 10 to 14 days.
Replace the reagents after 21 days of use.
2. Agitate the buffer pack daily to incorporate any solution that may have
condensed on the inside of the bottles.
3. Check the waste bottle and empty if necessary. See page 64.
4. Wipe the probe sleeve, sample area, reagent compartment, and
external surfaces with clean tissues moistened with 10% v/v bleach.
Do not spray into the measurement block.
Note Do not use any cleaning material containing alcohol, as this
could cause certain components to crack.
5. Clean the drip tray.
Verify that it is located properly and that the connector is fitted,
Cleaning or Replacing the Drip Tray, page 88.
6. Verify that the printer has enough paper.
If the red stripe is showing, replace the paper, page 88.

Weekly Maintenance
Equipment:
• Same as for daily maintenance, plus disinfectant, as required
• pH fill solution
• Na+/K+/Ca++/Cl– fill solution
• Reference fill solution, as required
1. Carry out daily maintenance and use the Disinfect routine (page 69).
2. Check the level of fill solution in the sensors:
• The reference sensor should be filled to the line.
• The pH, K+, Ca++ (or Cl–) sensors should be almost full, with only a
small bubble at the top
• The Na+ sensor should be full.
3. Refill the sensors if necessary. See Refilling or Replacing the
Measurement Sensors, page 80.

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Note The Hct sensor does not have fill solution. The pCO2 and pO2
sensors contain fill solution, but cannot be refilled. Slight discoloration
of the fill solution in these sensors is normal.
4. Check the sensors for air bubbles in the fill solution.
If necessary, remove the sensors and tap to dislodge air bubbles. See
Refilling or Replacing the Measurement Sensors, page 80.
5. Check the reference sensor for bubbles in the fill solution and for
crystal growth.
a. If air bubbles are present, remove the sensor and tap it to dislodge
air bubbles.
b. If crystal growth is present, remove the sensor, empty the fill
solution, and rinse with deionized water, then refill the sensor with
reference sensor fill solution.
c. Clean off excess fill solution using lint-free tissue and deionized
water.
d. Push a clot removal line into the vent hole to clear any fill solution
crystals.
See Replacing the Reference Sensor Cassette or Inner Electrode, page
83, for details.

Every-Other-Week Maintenance (or as Prompted via the

Action List)
Equipment:
• Same as for daily and weekly maintenance
• User Action Pack, or Deproteinizer, Conditioner, and Hct Slope
1. Carry out daily and weekly maintenance.
2. Deproteinize and condition the sensors. See Deproteinizing the
Sensors, page 67 and Conditioning the Sensors, page 68.
Note Depending on the way the system is configured, deproteinizing
and conditioning might be prompted more frequently than once every
two weeks - see Setting the Maintenance Prompts, page 154.
3. Carry out an Hct slope check. See Checking Hct Slope, page 53.
The instrument prompts for an Hct slope check after every Deproteinize
routine.

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Quarterly Maintenance
Equipment:
• Same as for daily, weekly, and every-other-week maintenance
• Pump tubing kits
• Screwdriver
• Mild detergent
• Dip tray, as required
1. Carry out daily, weekly, and every-other-week maintenance.
2. Replace the pump tubing and the pump rotor mouldings. See page 75.
3. Clean and lubricate the pump roller assembly. See page 77.
4. Date the pump tubing labels a maximum of 3 months ahead.
Note Under heavier workload conditions, replace the pump tubing
more frequently.
5. Replace the drip tray if it is becoming difficult to clean. See Cleaning or
Replacing the Drip Tray, page 88.

Six-month Maintenance
Equipment:
• Same as for daily, weekly, every-other-week, and quarterly
maintenance
• Bottle tubing kit
1. Carry out daily, weekly, every-other-week, and quarterly maintenance.
2. Replace the bottle tubing. See page 87.

Using the Action List to Prompt for Maintenance

You can choose how often some Action List prompts appear for
Deproteinize, Condition, QC, and Waste Bottle. See Setting the
Maintenance Prompts, page 154.
Other prompts—those for Sensors, Hct Slope, Gas, and Printer—appear
when the system detects that user action is required.
Note When the Action List prompts you to replace the gas cartridges or
empty the waste bottle, the system temporarily suspends its functions, so
that you can perform those actions without using the Stop System routine.

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Emptying the Waste Bottle

BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

1. Select Action List > Waste Bottle.

2. Remove the waste bottle:
a. Lift the front cover.
b. Carefully pull the waste bottle forwards, tilting the top slightly
away from you.
3. Cap the waste bottle and dispose of it in accordance with your
laboratory guidelines.
4. Prepare an empty wash bottle or an empty 7.3 buffer bottle from the
Buffer Pack for use as the new waste bottle:
a. Peel off the top label from the top, right corner to expose the waste
label.
b. To use the 7.3 buffer bottle, separate the label at the perforation.
c. Slide the 6.8 buffer bottle off and discard (Figure 3).

Figure 3: Separating Buffer Bottles

Note Siemens recommends that you put approximately 10 mL of

disinfectant or sodium hypochlorite into the waste bottle before placing it
in position.
5. Replace the waste bottle:
a. Tilt the top of the bottle away from you and slide the bottle into
position.

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b. Verify that the neck of the waste bottle is positioned underneath

the rubber cap.
The waste cap spout should be inside the neck of the waste bottle.

Figure 4: Replacing the Waste Bottle

1. Waste cap spout

6. Lower the cover.

7. Clear the Waste Bottle prompt by selecting Waste bottle.
8. Continue with further actions or select Back to exit to the Ready
screen.
9. Discard the waste bottle and its contents according to your laboratory
protocol. CLSI Publication GP05-A3 (Electronic Document) Clinical
Laboratory Waste Management gives detailed guidelines.3

Checking the Reagents

1. Check the reagent levels and change-by date regularly.
2. If either of the Buffer pack bottles or if the Wash bottle is empty, or if
the Buffer pack is past the change-by date, replace it as follows.

Changing the Reagents

Equipment:
• 6.8/7.3 Buffer pack
• Wash pack
1. Stop the system by selecting Ready > Settings > Maintenance > Stop
System.

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2. Wait for the System Stopped message.

3. Raise the front cover and remove and save the empty bottles for use as
new waste bottles.
See Emptying the Waste Bottle, page 64, for details about reusing
these bottles.
4. Remove the cap from the replacement bottle.
Retain the cap for use when replacing the waste bottle.
5. Feed the bottle tubing into the neck of the bottle and into the solution.
6. Tilt the top of the bottle slightly away from you and slide it into
position.

Figure 5: Positioning the Reagents

7. Press the cap firmly onto the neck of the bottle.

8. If you are changing the buffer bottles, date the label 21 days ahead.

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Figure 6: Dating the Buffer Label

9. Lower the front cover and select Restart to restart the system.
10. Select Ready > Settings > Maintenance > Prime.
11. When the Prime routine has finished pumping the new reagents
through the system, select Back twice to exit.
The system calibrates on return to the Ready screen.

Deproteinizing the Sensors

Equipment: User Action Pack or Deproteinizer
You can deproteinize the system when you get an Action List prompt or at
any time via the Maintenance menu.
1. Activate the Deproteinizer by mixing D1a and D1b:
a. Tap the vial (D1b) before opening to return all the pepsin powder
to the bottom of the vial.
b. Gently add solution D1a.
c. Cap and shake the vial until the powder has dissolved.
This takes a few seconds. The powder must be completely dissolved
before using the solution.

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Figure 7: Activating the Deproteinizer

2. Select Action List > Deproteinze, or Ready > Settings >

Maintenance > Deproteinize.
3. Following the instructions on the screen, lift the probe to the first
position and present the deproteinizing solution.
4. Hold the solution in place until prompted to remove it, then close the
probe.
5. Wait while the system performs the deproteinizing routine.
The deproteinizer remains in contact with the sensors for 5 minutes,
and the screen shows the time remaining. When deproteinizing is
finished, the system washes and calibrates on return to the Ready
screen. The system prompts for an Hct slope after a deproteinizing
routine.
6. To cancel the Deproteinize routine to measure a sample, select Cancel.
The system washes and calibrates on return to the Ready screen.

Conditioning the Sensors

Equipment: User Action Pack or Conditioner
Note Only the glass sensors (pH and Na+ sensors) require conditioning.
You can condition the sensors when you get an Action List prompt or at
any time via the Maintenance menu.
1. Select Action List > Condition, or select Ready > Settings >
Maintenance > Condition.
2. Following the instructions on the screen, lift the probe and present the
conditioning solution.
3. Hold the solution in place until prompted to remove it, then close the
probe.
The Conditioner remains in contact with the sensors for 5 minutes, and
the screen shows the time remaining. When conditioning is finished,
the system washes and calibrates on return to the Ready screen.

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4. To cancel the Condition routine to measure a sample, select Cancel.

The system washes and calibrates on return to the Ready screen.

Disinfectants to Use with the Disinfect Routine

BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

CAUTION
Use disinfectant in accordance with the manufacturer’s instructions.
Siemens cannot accept responsibility for the effectiveness of the
disinfectant used with the Disinfect routine.

We have tested the following disinfectants for compatibility with our

sensors:
• 1% or 2% Virkon
• 10% v/v bleach

CAUTION
Both Virkon and 10% v/v bleach affect the reference sensor. To prevent
damaging the reference sensor, if you use either of these two
disinfectants, you must remove the reference sensor and replace it with
an old sensor. Alternatively, use a Test blank sensor - ref (TB5).

Using the Disinfect Routine

The Disinfect routine pumps disinfectant through the probe and sample
path and leaves it in place for 10 minutes.

CAUTION
Perform the Disinfect routine before replacing the pump tubing, sensors
or the probe and tubing, and after analyzing a sample known or
suspected to contain dangerous pathogens.

Note To prevent protein fixation, we recommend deproteinizing the

system (page 67) before using the Disinfect routine.
Equipment:
• Bleach or Virkon solution

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Maintenance

• Test blank sensor, as required

CAUTION
Always observe good laboratory practices when handling any component
of the system under biohazardous conditions.

1. Select Ready > Settings > Maintenance > Disinfect.

2. Following the instructions on the screen, lift the probe to the first
position and present the disinfectant.
3. Hold the solution in place until prompted to remove it, then close the
probe.
The disinfectant remains in the measurement block for 10 minutes,
and the screen shows the time remaining. When the routine is finished,
the system washes and calibrates on return to the Ready screen.
4. To cancel the Disinfect routine to measure a sample, select Cancel.
The system washes and calibrates on return to the Ready screen.
5. Preferably, remove the probe and tubing, page 92, measurement block
tubing, page 92, and sample pump tubing, page 75, and replace them
with new tubing.
Note Alternatively, you can soak these tubes for 10 minutes in 10%
v/v bleach and replace them, but replacing them with new tubing is
preferable.

Stopping the System

The Stop System routine suspends instrument functions, such as
calibrations, while you are carrying out routine maintenance such as
changing the reagents, sensors, pump tubing, and bottle tubing, or
clearing blockages.

CAUTION
Do not leave the system stopped for longer than necessary, as this might
damage the sensors and pump tubing.

1. From Ready select Menu.

2. Select Maintenance.
3. Select Stop System.
If the beeper is enabled, the system beeps once per second after 30
minutes in Stop System.

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4. Perform the maintenance task.

5. To quiet the beeper, if necessary, select Cancel Beeper when that
option appears.
6. Select Restart to restart the system.

Using the Prime Routine

The Prime routine drains and pumps solution and gases through the
system. Use the Prime routine when replacing the pump tubing, changing
reagents, or pumping disinfectant through the manifold.
Note If you are changing the gas cartridges, it is not necessary to drain the
system.

Draining the System

1. Raise the front cover and remove the Buffer pack and Wash bottle.
Do not remove the Waste bottle.
2. Place tissues under the bottle tubes to catch any spillage.
3. Select Ready > Settings > Maintenance > Prime.
The system pumps and drains the system.

Priming the System

1. Perform the appropriate maintenance procedure.
2. Select Ready > Settings > Maintenance > Prime.
The system primes.
3. After the system primes, select Back twice to return to the Ready
screen.

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Changing the Gas Cartridges

CAUTION
• Use only Siemens gas cartridges supplied for use with the system, as
they have been designed for ease of use and optimum performance.
• Siemens assumes no liability for performance if cartridges other
than those specified for use with the system are used.

WARNING
Compressed gas cartridges require careful handling. To prevent damage
and possible personal injury, observe the following precautions:
• Never install other gases, for example, propane cartridges.
• Never drop cartridges, allow them to strike each other or subject
them to other strong shocks.
• Never tamper with the cartridge valves.
• Use these gases only for the calibration of clinical and research
instrumentation. (US Law prohibits dispensing these gases for drug
use.)
• Do not puncture the cartridges. The contents are under pressure.
• Do not use or store near heat or open flame.
• Do not expose cartridges to temperatures above 54°C (130°F) as this
may cause the contents to vent or explode.
• Never throw cartridges into fire or incinerators. Dispose of the empty
cartridges following your laboratory protocol.

Equipment:
• Gas cartridge pack
• Gas cartridge removal tool and Gas cartridge venting tool
The system detects when the gas pressure is low and prompts you to
change the gas cartridges via the Action List.
Note When the gas low prompt appears, less than 5% of the gas
remains, and you can safely dispose of the cartridges.
1. Select Ready > Action List > Gas.
Note Always replace both gas cartridges.
2. Unscrew the gas cartridges by turning them in a counterclockwise
direction, using the removal tool if necessary.

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3. Slide both cartridges out of the gas cartridge compartment.

4. If required, vent any remaining gas using the venting tool:
a. Remove the cartridge to a well ventilated area.
b. Point the cartridge away from yourself, and from other people.
c. Insert the venting tool as shown.
You might hear a slight hiss as the gas vents.

Figure 8: Venting the Gas Cartridges

5. Dispose of the empty gas cartridges according to your laboratory

protocol.
6. Install the new cartridges:

CAUTION
The cartridges and cartridge compartment are clearly marked and color
coded: gas 1 (blue) and gas 2 (black). See Figure 9. Make sure the
cartridges are installed in the correct position.

a. Remove the plastic protective cap from the cartridge valve.

b. Slide the cartridge into the compartment, and then gently push and
turn the cartridge clockwise to engage it with the regulator.
c. Screw the cartridge in until finger tight.
Note The gas regulator assembly is designed to make a good seal by
finger tightening only. Do not overtighten the cartridges, either by
using tools or by applying excessive force.

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Figure 9: Changing the Gas Cartridges

7. Prime the system. See Priming the System, page 71.

Checking the Gas Flow Rate

1. Initiate a full 2-point calibration by selecting Ready > Settings >
Calibration > Full 2 Point.
The system checks the gas flow rate while measuring the gas.
2. When the calibration gas values appear on the display, lift the probe
lever to the first position.
3. Fit a capillary adaptor to the end of the probe.
This makes the bubbles easier to count.
4. Present a small beaker of deionized water to the probe and count the
bubbles for at least 15 seconds.
The bubble rate should be greater than 5 bubbles/15 seconds
(20 bubbles/minute)
5. Remove the capillary adaptor and close the probe.
6. When the slope gas values appear on the display, lift the probe and
repeat steps 2 through 5 for the slope gas.
7. If either of the gas flow rates is incorrect, contact your local technical
provider or distributor.

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Changing the Pump Tubing and Cleaning and Lubricating

the Rollers
BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Equipment:
• Pump tubing kits
• Screwdriver
• Mild detergent
• Disinfectant
The system has 2 sets of pump tubes: the sample pump tubing (2 tubes),
on the left, and the reagent tubing (3 tubes), on the right. For optimum
performance, change both pump tubing kits together, on or before the
dates shown on the label.

Changing the Pump Tubing

1. Use the Disinfect routine, then drain the system. See Using the
Disinfect Routine, page 69 and Draining the System, page 71.
2. Stop the system. See Stopping the System, page 70.

Changing the Sample Pump Tubing

1. Remove the waste bottle.
2. Disconnect the waste cap connector from the manifold.
3. Disconnect the sample tube from the measurement block tube, and the
waste tube from the manifold.
4. Release the tension on the tubes by pulling each tube down and to the
side until the lug is clear of the tensioner.
5. Remove the pump tubing.

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Figure 10: Removing the Sample Pump Tubing

1. Tensioner
2. Measurement Block Tube
3. Waste Tube
4. Lug
5. Waste Cap Connector

Changing the Reagent Pump Tubing

1. Disconnect the rubber connector from the manifold.
2. Release the tension on the tubes by pulling each tube down and to the
side until the lug is clear of the tensioner.
3. Remove the reagent pump tubing, Figure 11.

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Figure 11: Removing the Reagent Pump Tubing

1. Rubber Connector

Cleaning the Rollers

1. Remove the finger screw holding the pump rotor in place and slide the
rotor off the moulding.
Note The drive pin, Figure 12, might drop out.

Figure 12: Removing the Pump Rotor

1. Drive Pin

2. Remove the pump rotor mouldings by pulling the pump rotor ends
apart. See Figure 13.

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Figure 13: Removing the Pump Rotor Mouldings

3. Wash the rollers in mild detergent solution, rinse, and dry with tissues.

Lubricating the Rollers

1. With the grease supplied, lightly lubricate each roller at the points
shown in Figure 14.

Figure 14: Lubricating the Rollers

1. Lubrication Points

2. Re-assemble the rotor using the new pump rotor mouldings.

3. Replace the pump rotor.
4. Make sure the drive pin is located correctly.

Installing New Pump Tubing

Date the label a maximum of 3 months ahead. See Figure 15.

Figure 15: Dating the Pump Tubing Label

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Installing New Sample Pump Tubing

1. Install the new sample pump tubing:
a. Connect the waste cap connector to the manifold.
b. Push firmly into position.
2. Place the pump tubes over the rotor.
The tube with the grey connector goes in the back position.
3. Connect the back tube to the manifold.
4. Connect the front tube to the measurement block tube.
5. Pull the tube lugs underneath the tensioners.
6. Replace the waste bottle.

Installing New Reagent Pump Tubing

1. Install the new reagent pump tubing:
a. Loop the pump tubes over the rotor.
The thick tube goes in the back position.
b. Pull the tube lugs underneath the tensioners.
c. Connect the rubber connector to the manifold.
d. Push the connector firmly into position.
e. See Figure 16 to make sure the tubes are fitted correctly.

Figure 16: Reagent Pump Tubing Correctly Installed

2. Ensure that no pump tubes are pinched or twisted. See Figure 17.

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Figure 17: Example of Twisted Tube

3. Replace the reagent bottles, lower the front cover, and restart the
system.
4. Prime the system. See Priming the System, page 71.

Refilling or Replacing the Measurement Sensors

BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Equipment:
• pH fill solution, as required
• Na+/K+/Ca++/Cl–fill solution, as required
• Replacement sensors, as required
• Disinfectant
Note Although the pCO2 and pO2 sensors contain fill solution, they cannot
be refilled. To replace the pCO2 and pO2 sensors, or the Hct sensor, follow
the instructions in steps 1–5 and 8–10.
1. Use the Disinfect routine. See Using the Disinfect Routine, page 69.
2. Stop the system. See Stopping the System, page 70.
3. Raise the front cover.
4. Slide the measurement block catch down and raise the block door. See
Figure 18.

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Figure 18: Opening the Measurement Block Door

5. Swing the tensioner to the right and press the tensioner lock button to
hold the tensioner in the open position.
6. Remove the appropriate sensor. See Figure 19.

Figure 19: Removing a Sensor

Refilling the pH, Na⁺, K⁺, Ca⁺⁺, or Cl⁻ Sensor

CAUTION
• Make sure you use the correct fill solution - pH fill solution for the pH
sensor, and Na+/K+/Ca++/Cl–fill solution for the Na+, K+, Ca++, or Cl–
sensor. Do not use reference sensor fill solution.
• Do not touch the inner electrode as it is fragile and easily damaged.

1. Referring to Figure 20, Refilling the pH/Na+/K+/Ca++/Cl– Sensor ,

unscrew the inner electrode and set it aside on lint-free tissue.

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2. Empty the fill solution out of the sensor.

3. Fit a needle to the fill solution container, rinse out the sensor body with
a few drops of fill solution and refill the sensors almost full, leaving a
small bubble at the top.
4. Tap the sensor during filling to dislodge air bubbles.
Note If you are refilling the Na+ sensor, fill to the top. Do not leave an
air bubble.
5. Replace the inner electrode.
Screw the electrode down tightly. Be careful not to cross-thread the
electrode.
6. Shake the sensor down by holding it in your hand and flicking your
wrist several times to dislodge air bubbles at the sensor capillary.

Figure 20: Refilling the pH/Na+/K+/Ca++/Cl– Sensor

7. Wipe the sensor with dry, lint-free tissue and verify that the O-ring is in
position on the left side, and is in good condition.
8. Tap the sensor to release any trapped air bubbles.

Reinstalling the Sensor

1. Install the sensor top first, aligning the sensor contacts.
2. Press the bottom of the sensor into position.
3. Hold the tensioner and press the tensioner lock button.
4. Gently release the tensioner and push it firmly home to make a good
seal.
5. Lower the block door, snapping it into place.
6. Lower the front cover.

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7. Select Restart to restart the system.

The system calibrates on return to the Ready screen.
Note Siemens recommends that you use the condition routine after
refilling or replacing a pH or Na+ sensor.
A new sensor might take up to 90 minutes to stabilize. The system
deselects a sensor if it fails calibration, but monitors it and automatically
reselects it when it meets calibration specifications.

Replacing the Reference Sensor Cassette or Inner

Electrode
BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Equipment:
• Reference sensor cassette, as required
• Reference inner electrode, as required
• Disinfectant
• Clot removal line
1. Use the Disinfect routine. See page 69.
2. Stop the system. See page 70.
3. Raise the front cover.
4. Slide the measurement block catch down and raise the block door.

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Figure 21: Opening the Measurement Block Door

5. Swing the tensioner to the right and press the tensioner lock button to
hold the tensioner in the open position.
6. Remove the reference sensor (Figure 22).

Figure 22: Removing the Reference Sensor

CAUTION
Make sure you use reference fill solution. Do not use pH or Na+/K+/Ca++/
Cl–sensor fill solution.

CAUTION
Do not touch the reference inner electrode, as it is fragile and easily
damaged.

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7. Replace the reference sensor cassette:

a. Break the top off the reference fill solution container, and fit the
needle.
b. Slowly inject solution into the internal reference compartment of
the new cassette.
c. Continue filling until the liquid level is flush with the sensor
reservoir (Figure 23).

Figure 23: Filling the Internal Reference Compartment

1. New Cassette

d. Use the hex tool supplied to remove the reference inner electrode
and reservoir cap.
e. Remove the inner electrode from the old cassette, or, if you are
installing a new reference inner electrode, remove it from its
container, and screw it into the new internal reference
compartment.
Do not cross-thread the inner electrode (Figure 24).

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Figure 24: Changing the Reference Inner Electrode

1. Old Cassette
2. New Cassette

f. Inject the remaining fill solution into the reservoir up to the fill line
and replace the reservoir cap until finger tight (Figure 25).

Figure 25: Filling the Reference Reservoir and Replacing the Cap

g. Tilt the reference cassette and tap the front with your knuckle to
remove air bubbles.
h. Carefully clean off any excess fill solution using clean lint-free
tissue and deionized water.
i. Push the clot removal line through the vent hole to clear any fill
solution crystals.
8. Verify that O-rings are fitted to each side of the sensor and are in good
condition.
9. Refit the reference sensor top first, aligning the sensor contacts.

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10. Press the bottom of the sensor into position.

11. Make sure all the sensors are seated correctly.
12. Hold the tensioner and press the tensioner lock button.
13. Gently release the tensioner and push it firmly home to make a good
seal.
14. Lower the block door, snapping it into place.
15. Lower the front cover.
16. Select Restart to restart the system.
The system calibrates on return to the Ready screen.
Note Following a change of reference sensor cassette or inner electrode, it
is normal for the system to require a stabilization period of 30 minutes
before attaining optimum performance. If an over- or under-range
condition is present on the pH and electrolyte channels, an air bubble is
probably trapped in the reference sensor (Figure 26). Remove the sensor
and tap it until the air bubble is dislodged. Re-install the sensor.

Figure 26: Trapped Air Bubble in Reference Sensor

1. Vent Hole
2. Trapped Air Bubble

Replacing the Bottle Tubing

Equipment: Bottle tubing kit
1. Drain the system. See Draining the System, page 71.
2. Stop the system. See Stopping the System, page 70.

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3. Disconnect the three sets of bottle tubing from the manifold. See
Figure 27.
4. Install the new bottle tubing, making sure that the 6.8 bottle tubing is
fitted in the correct position.

Figure 27: Changing the Bottle Tubing

1. 6.8 Bottle Tubing

5. Replace the Buffer Pack and Wash bottle:

a. Feed the bottle tubing into the neck of the bottles and into the
solution.
b. Tilt the top of the bottle slightly away from you and slide it into
position.
6. Lower the front cover and select Restart.
7. Prime the system, page 71.

Cleaning or Replacing the Drip Tray

BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Equipment:
• Drip tray
• Disinfectant
1. Stop the system. See page 70.
2. Raise the front cover.
3. Lift the probe lever to the second position.

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4. Disconnect the drip tray connector from the manifold.

The drip tray is held in place by a magnet, and you will feel some
resistance as you remove it.
5. Hold the drip tray at the bottom and pull upwards and out
(Figure 28).

Figure 28: Removing the Drip Tray

1. Drip Tray Connector

CAUTION
The drip tray is not designed to be autoclaved and reused.

6. Clean the drip tray with disinfectant.

Replacement drip trays are available (see Appendix C, Orderable
Supplies) if it becomes difficult to clean.
7. Refit the drip tray, making sure the connector is reconnected to the
manifold.

WARNING
Do not operate the system without the drip tray in place. The drip tray is
designed to contain any blood drips, and to keep the probe clean. Failure
to install it could result in a build up of blood deposits, and a potentially
biohazardous situation.

8. Lower the front cover and restart the system.

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Maintenance

Replacing the Printer Paper

Equipment: Printer paper

CAUTION
Use only Siemens printer paper. Other paper might affect print quality or
damage the printer.

Note Replace the printer paper when the red stripe appears or when
prompted by the system via the Action List.
1. Press the printer cover release button to open the printer cover
(Figure 29).

Figure 29: Opening the Printer Cover

1. Printer cover release button

2. Printer cover

2. Tilt the paper compartment cover backwards.

3. Tear off any remaining paper, and remove the old paper roll.
4. Hold the new paper roll in one hand with the paper coming from the
bottom of the roll and towards you.

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5. Bend the end of the paper back slightly.

CAUTION
Make sure you feed the paper correctly. If the paper is fed in incorrectly,
the printer will not print, and it might cause paper jams.

6. Insert the new paper roll into the compartment, making sure that the
paper is square to the printer and that at least 5 cm (2 inches) of the
paper protrudes from the roll (Figure 30).

Figure 30: Loading the Printer Paper

1. Printer cover
2. Thermal paper roll

7. Firmly close the paper cover.

8. Test the printer, to check that the printout is clear.
Do not forcefully pull the thermal paper, as severe damage might
occur. If a problem exists, see Printer Issues, page 129 for
troubleshooting information.

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Maintenance

Replacing the Probe and Tubing and Probe Housing

BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Removing the Current Probe, Tubing, and Housing

Equipment:
• Probe and tubing kit or Probe and housing kit, as required
• Disinfectant
1. Use the Disinfect routine and then stop the system, page 69 and
page 70.
2. Raise the front cover.
3. Lift the probe lever to the second position (Figure 31).

Figure 31: Probe Lever Positions

1. Closed Position
2. First Position
3. Second Position
4. Holding past the second position

4. Push the probe connector to the left and pull it out of the reagent inlet
connector (Figure 32).

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Figure 32: Disconnecting the Probe Connector

1. Probe Connector

5. Lift the probe lever past the second position and hold in place
(Figure 31).
6. Carefully hold the probe sleeve and pull firmly to remove the probe
housing.
7. Release the probe lever and remove the probe housing (Figure 33).

Figure 33: Removing the Probe Housing

8. If you are replacing both the probe and the housing, lower the probe
lever and go to Replacing the Reference Sensor while Replacing Probe,
page 96, step 8. Otherwise, continue with the next step in the current
procedure.
9. To clean the probe and housing, perform the following steps:
a. Soak the assembly for 10 minutes in 10% v/v bleach.

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Maintenance

b. Rinse with deionized water and gently dry with tissues.

c. Lightly grease the probe shaft mechanism (use the grease supplied
with the pump tubing kit) (Figure 34).

Figure 34: Greasing the Probe Shaft Mechanism

1. Probe Shaft Mechanism

10. Disconnect the probe tubing from the housing (Figure 35).

Figure 35: Disconnecting the Probe Tubing from the Probe Housing.

11. Pull the probe out of the housing (Figure 36).

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Figure 36: Removing the Probe from the Probe Housing

12. Discard the old part.

WARNING
Make sure the old probe is disposed of safely, in accordance with your
laboratory guidelines.

Reassembling the Probe and Housing

1. Using replacement parts as required, feed the probe down through the
hole in the probe sleeve, making sure it is seated correctly (Figure 37).

Figure 37: Probe Sleeve Hole

1. Probe Sleeve Hole

2. Connect the probe tubing to the housing.

3. Lift the probe lever past the second position and hold in place.
4. Hold the probe sleeve and slide the probe housing up the lever guides
into position in the lever.

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Maintenance

5. Release the probe lever (Figure 38).

Figure 38: Replacing the Probe Housing

6. If necessary, fit O-rings to the probe connector.

7. Slide the probe connector back into the reagent inlet connector.
8. Lower the probe lever.

Replacing the Reference Sensor while Replacing Probe

1. Remove the reference sensor.
See Replacing the Reference Sensor Cassette or Inner Electrode, page
83, steps 1–5.
2. Disconnect the measurement block tube from the sample pump
tubing. See Figure 39.

Figure 39: Disconnecting the Measurement Block Tube

3. Remove the measurement block tube and discard (Figure 40).

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Figure 40: Removing the Measurement Block Tube

CAUTION
Take care when handling the measurement block tube as the residue
from some protective gloves can adhere to the tube and therefore affect
the fluid detector (FD2).

4. Fit the new measurement block tube and reconnect the sample pump
tubing.
5. Replace the reference sensor, page 83, step 7.
6. Lower the front cover and restart the system.
7. To promote good flushing characteristics:
a. Raise the probe lever to the first position.
b. Immerse the tip of the probe in a small beaker of strong soap
solution for 10 to 15 seconds.
c. Lower the probe lever and Prime the system, page 71.
Replacing the Probe Protector
BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Equipment:
• Probe protector
• Probe and tubing kit
• Probe and housing kit
1. Remove the probe housing and probe. See page 92, steps 1–7.
Do not discard the probe or housing.

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Maintenance

2. Remove the probe protector from the probe housing (Figure 41).

Figure 41: Removing the Probe Protector

3. Fit a new probe protector.

4. Reassemble the probe and housing. See Reassembling the Probe and
Housing, page 95.
5. Lower the front cover and restart the system.

Replacing the Pre-heater Tube

BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Equipment:
• Pre-heater tube kit
• Phillips screwdriver
• Disinfectant
1. Use the Disinfect routine and then stop the system. See Using the
Disinfect Routine and Stopping the System, page 70.
2. Remove the probe and probe housing. See Page Removing the Current
Probe, Tubing, and Housing, page 92.
3. Remove the pO2 and pCO2 sensors. See Refilling or Replacing the
Measurement Sensors, page 80.
4. Disconnect the reagent manifold connector (Figure 42).

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Figure 42: Pre-heater Components

1. Pre-heater Cover
2. Sample Detector Cover
3. Reagent Manifold Connector

5. Remove the sample detector cover.

6. Remove the screw from the pre-heater cover and remove the cover.
See Figure 43.

Figure 43: Removing the Sample Detector Cover

CAUTION
Handle the pre-heater tube carefully, as it is fragile and can easily be
pinched.

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Maintenance

7. Slide the reagent inlet connector towards you.

8. Ease the pre-heater tube from the groove in the pre-heater.
9. Carefully push the tube towards the measurement block to free the
block connector (Figure 44).

Figure 44: Removing the Pre-heater Tube

1. Reagent Inlet Connector

2. Pre-heater Tube
3. Plastic Moulding
4. Block Connector

10. Ease the pre-heater tube under the plastic moulding.

11. Re-assemble using the new pre-heater tube assembly, making sure that
the following conditions are met:
• The pre-heater tube is in the pre-heater groove, and the block
connector is in place.
• The reagent inlet connector is in place.
• The pre-heater cover and sample detector cover are replaced.
• The reagent manifold connector is connected.
• The pO2 and pCO2 sensors are replaced and seated correctly, and
the block door is closed.
12. Replace the probe and probe housing. See Replacing the Probe and
Tubing and Probe Housing, page 92.

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13. Lower the front cover and restart the system.

Clearing Blockages
BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

Always wear protective gloves when carrying out this procedure, and avoid
spray contamination when clearing blockages with water.
Equipment:
• Clot removal line
• 1-mL syringe, as required

CAUTION
Use only Siemens clot removal line, as other materials might damage the
system.

1. Stop the system, page 70.

Clearing a Blockage in the Probe

1. Remove the probe and housing. See Replacing the Probe and Tubing
and Probe Housing, page 92.
2. Carefully thread the clot removal line up the probe until it appears
through the probe connector, then pull the line through (Figure 45).

Figure 45: Clearing a Blockage in the Probe

Clearing a Blockage in the Pre-heater

1. Remove the pre-heater tube assembly. See Replacing the Pre-heater
Tube, page 98.

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Maintenance

2. Pass the clot removal line through the pre-heater tube then pull the
line through the reagent inlet connector (Figure 46).

Figure 46: Clearing a Blockage in the Pre-Heater

Clearing a Blockage in the Sensors

1. Remove the sensors. See Replacing the Reference Sensor Cassette or
Inner Electrode, page 83.
2. Use the syringe filled with deionized water to carefully inject water
through the sensors but apply only very gentle pressure (Figure 47).

Figure 47: Clearing a Blockage in the Sensors

Clearing a Blockage in the Drip Tray Connector Drain

Hole
1. Remove the drip tray. See Cleaning or Replacing the Drip Tray, page
88.

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2. Carefully inject water into the ports in the back of the drip tray
connector (Figure 48).

WARNING
Point the drip tray away from you while you inject water into the ports.

Figure 48: Clearing a Blockage in the Drip Tray Connector Drain Hole

3. Disconnect the measurement block tube from the sample pump tubing
connector (Figure 49).

Figure 49: Disconnecting the Measurement Block Tube

4. Thread the clot removal line up the measurement block tube until it
appears in the measurement block.
Pull the line through (Figure 50).

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Maintenance

Figure 50: Clearing a Blockage in the Measurement Block Tube

5. Carefully inject water into the sample pump tubing, until water appears
at the waste cap (Figure 51).

Figure 51: Clearing a Blockage in the Sample Pump Tubing

6. Reconnect the sample pump tubing to the measurement block tube.

Clearing a Blockage in the Manifold

1. Disconnect the waste tube from the manifold (Figure 52).

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Figure 52: Clearing a Blockage in the Manifold

1. Drip Tray Drain Hole

2. Gently inject water into the waste tube port until it appears at the drip
tray drain hole.
3. Hold tissues against the drain hole to catch the drips.
4. Re-assemble the system, restart the system and deproteinize the
sensors, page 67.

Replacing Fuses
Equipment:
• Fuses: 250 V, T-1.25 A
• Flat-head screwdriver

WARNING
For continued protection against fire hazard, replace fuses only with the
same type and rating of fuse that was originally in the system.

1. Contact your local technical provider or distributor to order

replacement fuses.
2. Turn the system so that the back panel is facing you.
The fuse holder is located in the back panel between the power cord
and the power switch. It contains 2 fuses. Both fuses are required.
3. Turn the system off using the power switch.
4. Disconnect the power supply cord.

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5. Locate the 2 grooves on the sides of the fuse holder.

The fuse cover has 2 grooves to the left and 2 grooves to the right of it.

CAUTION
Ensure you place the screwdriver blade in the smaller groove. You can
damage the fuse block by placing the blade in the larger groove.

6. Insert the blade of a small flat-head screwdriver into the smallest

groove on the left of the fuse holder.
7. Exert pressure to unsnap the left side of the fuse holder.

Figure 53: Opening the Fuse Cover

1. Small Grooves

8. Repeat steps 6–7 for the right groove.

9. Remove the fuse holder from the system.
10. Remove and dispose of the blown fuse or fuses (Figure 54).

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Figure 54: Replacing Fuses

1. Fuse
2. Fuse Block

11. Insert the spare fuse onto the fuse block.

12. Insert the fuse holder securely into the system.
13. Reconnect the power supply cord.

Shutting Down the System

BIOHAZARD
See Section 1, Safety Information, for recommended precautions when
working with biohazardous materials.

1. Wear gloves while carrying out the following procedures.

CAUTION
Siemens recommends that the system remain connected to the AC power
supply at all times, so it is always ready for immediate use. When used as
recommended will not require a warm-up period. However, if you must
turn off the system, either by using the power switch or by disconnecting
it from the AC supply, follow this shutdown procedure to prevent
damage to the system.

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Equipment:
• Disinfectant; bleach
• Tissues
1. Print the setup report and retain so that you have a record of all the
settings. See Printing the Setup Report, page 157.
2. Use the Disinfect routine, Using the Disinfect Routine, page 69.
3. Disinfect the manifold and bottle tubing, and drain the system:

CAUTION
To prevent damaging the reference sensor if you use Virkon or 10% v/v
bleach, you must remove the sensor and replace it with an old sensor, or
a Test blank sensor - ref (TB5)

a. Remove the buffer pack and wash bottle and replace with a beaker
of disinfectant.
Do not remove the waste bottle.
b. Select Ready > Settings > Maintenance > Prime.
c. When the Prime routine finishes, remove the disinfectant and
replace with a beaker of deionized water.
d. Select Ready > Settings > Maintenance > Prime again to flush the
system with water.
e. When the Prime routine finishes, remove the beaker of water.
f. Place tissues under the bottle tubes to catch any drips.
g. Select Ready > Settings > Maintenance > Prime again to drain the
system.
h. Remove the waste bottle and cap it.
4. Unscrew and remove the gas cartridges.
5. Power off the system using the power switch.
6. Disconnect the line cord from the power supply socket if necessary.
7. Remove the probe and housing and immerse in 10% v/v bleach for 10
minutes. See page 92.
8. Rinse the probe and housing with deionized water, then gently wipe
dry.
If necessary, grease the probe shaft lightly with the grease supplied
with the pump tubing kit.
9. Remove the measurement sensors. See page 80.

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10. Remove the reference sensor. See page 83.

If you are removing the reference sensor from the system for more
than 12 hours, follow this procedure to prevent damage to the Nafion
inner electrode :
a. Remove the inner electrode and store it in its container in saturated
KCl.

CAUTION
Do not leave the inner electrode out of solution for longer than 10
minutes.

b. Shake out the remaining KCl solution from the sensor cassette and
rinse with deionized water.
c. Flush the reference sensor sample path with deionized water, and
allow the cassette to dry.
d. To reactivate the reference sensor follow the procedure for
installing a new sensor cassette.
11. Wipe the measurement block to remove any reference fill solution.
12. De-tension the pump tubes.
13. Clean the drip tray.
14. Wipe the external surfaces with tissues and 10% v/v bleach.

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8 Troubleshooting

• System Setup or Power Faults, page 111

• General Troubleshooting Procedures, page 111
• System Not Ready, page 112
• Calibration Failures, page 112
• Suspect Patient Results, page 125
• Sample Not Detected or Sampling Faults, page 127
• Printer Issues, page 129
• Heater Failure, page 129
• Using the Troubleshooting Routines, page 129
• Other Problems, page 137

System Setup or Power Faults

The system continually performs self-diagnostic tests to maintain integrity
of results. If the system detects a possible system setup fault, or if the
system battery has failed or is failing, the system displays the Check Setup
screen and resets the setup options to default values.
Note You can still use the system in this situation, but the data relating to
the result is set to default (factory set) values.
1. Check the setup options in Configuring Operating Setup, page 149,
and Configuring System Setup, page 154.
2. Check the barometer calibration setting, See Calibrating the
Barometer, page 51.
3. When you have checked all the setup options, select OK to clear the
Check Setup message and exit to the Ready screen.

General Troubleshooting Procedures

1. Ensure that the system is turned on and that all connections are secure.
2. Read the on-screen messages for indications of what is causing the
problem.
3. Following a calibration, print the results and check the printout for
further indications.
4. Consult the troubleshooting tables in this section.

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Troubleshooting

System Not Ready

A Not Ready message indicates that the system is powered on but not yet
ready for use.
1. Read the Not Ready message to determine what is causing the
condition.
If you have just powered on the system, the Not Ready message
indicates that the system is warming up. See What You Can Do during
Warmup, page 34.
2. If the Not Ready condition indicates that the system is in Standby
mode, select Standby > Restart or Standby > Select Auto Restart
Time.
3. If an error exists, follow the directions on the screen to clear the error
condition.
4. If you have raised the probe, close the probe before proceeding.
Note If more than one error condition exists at startup, clearing the
current error condition allows any lower-priority errors to display.

Calibration Failures
• Calibration or Slope Drift, page 114
• Calibration or Slope No Endpoint, page 117
• Calibration or Slope Outside Range, page 120
• Fluidics Failure, page 123

Viewing the Calibration Summary on the Screen

1. To view the troubleshooting indicators on the touch screen display,
select Ready > Settings > Troubleshooting > Sensors.
The same indicators appear on the display as on the printed summary.
2. Select the element you want to troubleshoot.
Calibration problems might also be caused by fluidics failures or by
hydraulic problems. These conditions do not appear on the calibration
summary. See the fluidics issues listed in the troubleshooting table in
Fluidics Failure, page 123 for information. If hydraulic problems occur,
contact your Siemens service representative.

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Troubleshooting

Printing the Calibration Summary

1. To print the calibration summary to see possible further details of the
problem, select Ready > Settings > Data Recall > Print Cal Summary.
2. Review the display or the printed calibration summary for the following
indicators next to individual sensors:

Indicator Calibration or slope condition

↑ or ↓ Drift
* No endpoint
! Outside range

These same indicators appear on the Measuring Calibration screen.

Select Ready > Settings > Calibration, then select the type of
calibration you want to perform, next to the appropriate
measurements.

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Troubleshooting

Calibration or Slope Drift

Possible Cause Action/Reference
New Sensor
Instability in newly installed sensor. Wait for sensor to stabilize. New sensors might
take up to 90 minutes to stabilize. The system
deselects a sensor if it fails calibration, but
monitors the failed sensor and automatically
reselects it when it meets calibration
specifications.
Reference Sensor (pH/Electrolyte Drift)
Bubble in reference sensor. Debubble the sensor.
Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
Nafion inner electrode is dry due to Replace Nafion inner electrode if it is dry, or refit it
a large bubble, or is not screwed correctly.
down properly, or fits poorly. Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
Sensor is clogged with crystals Empty the sensor cassette and refill carefully with
caused by poor filling, or bubbles reference sensor fill solution.
creating crystal growth. Replacing the Reference Sensor Cassette or Inner
Note This applies only to the Electrode, page 83.
reference sensor.
Vent hole is blocked. Unblock the vent hole in the reservoir cap.
Clearing Blockages, page 101.
Failed or leaking membrane. Replace the sensor cassette.
Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
pH/Na+/K+/Ca++ or Cl– Sensor
Sensor needs deproteinizing and/or • Deproteinize the sensor.
conditioning. Deproteinizing the Sensors, page 67.
Note Any sensor might require • Condition the sensor.
deproteinizing, but only the glass
Conditioning the Sensors, page 68.
sensors (pH and Na+ sensors)
require conditioning.
Bubbles in fill solution, or Debubble the sensor, or empty and refill.
insufficient or concentrated fill Refilling or Replacing the Measurement Sensors,
solution. page 80.
The problem might also be caused
by the reference sensor.

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Troubleshooting

Possible Cause Action/Reference

pCO2/pO2 Sensor
Sensor needs deproteinizing. Deproteinize the sensor.
Deproteinizing the Sensors, page 67.
Sensor failure. • Confirm failure by Measurement Block
routine.
Measurement Block Routine, page 130.
• Replace the sensor.
Refilling or Replacing the Measurement
Sensors, page 80.
Hct Sensor
Dampness around the sensor • Dry off measurement block, contacts, and
sensor.
• Check sensor O-ring seal and replace if
necessary.
• Ensure that sensors are seated properly, and
the tensioner is pushed firmly home.
Refilling or Replacing the Measurement
Sensors, page 80.
Insufficient reagent/wash delivery. Ensure that the reagents/wash bottles contain
sufficient solution.
Checking the Reagents, page 65.
Bubbles in sensor or sample path. • Ensure that the reagent pump tubing is
tensioned.
• Ensure that the measurement block tube is
connected to the pump tubing.
• Replace the pump tubing.
Changing the Pump Tubing, page 75.
• Check pre-heater assembly tubing. Replace
pre-heater assembly.
Replacing the Pre-heater Tube, page 98.
Poor measurement block washout, • Ensure that pump tubing is tensioned.
no or insufficient "pull" on sample • Ensure that measurement block tube is
line. connected to the pump tubing.
• Replace the pump tubing.
Changing the Pump Tubing, page 75.
Sensor needs deproteinizing. Deproteinize the sensor.
Deproteinizing the Sensors, page 67.

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Troubleshooting

Possible Cause Action/Reference

Unsuccessful slope. • Carry out calibration routine and slope, using
a fresh slope ampule.
• Repeat calibration routine and slope at least
twice more, using a fresh slope ampule on
each occasion.
Sensor failure. • Confirm failure by Measurement Block
routine.
Measurement Block Routine, page 130.
• Replace the sensor.
Refilling or Replacing the Measurement
Sensors, page 80.
System
Dampness around the sensor. • Dry off measurement block, contacts, and
sensor.
• Check sensor O-ring seal and replace if
necessary.
• Ensure that sensors are seated properly, and
the tensioner is pushed firmly home.
Refilling or Replacing the Measurement
Sensors, page 80.
Partial blockage in sensors. Clear the blockage.
Clearing Blockages, page 101.
Gas cartridges connected incorrectly • Ensure that cartridges are connected
or gas flow rate incorrect. correctly and installed in correct position.
Changing the Gas Cartridges, page 72.
• Check gas flow rate.
Checking the Gas Flow Rate, page 74.
Barometric pressure incorrect or Enter correct barometric pressure.
changed. Calibrating the Barometer, page 51.

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Troubleshooting

Calibration or Slope No Endpoint

Possible Cause Action/Reference
Reference Sensor (pH/Electrolyte Drift)
Bubble in reference sensor. Debubble the sensor.
Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
Nafion inner electrode is dry due to Replace Nafion inner electrode if dry, or refit it
a large bubble, or is not screwed correctly.
down properly, or fits poorly. Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
Sensor is clogged with crystals Empty the sensor cassette and refill carefully with
caused by poor filling, or bubbles reference sensor fill solution.
creating crystal growth. Replacing the Reference Sensor Cassette or Inner
Note This applies only to the Electrode, page 83.
reference sensor.
Vent hole is blocked. Unblock the vent hole in the reservoir cap.
Clearing Blockages, page 101
Failed or leaking membrane. Replace the sensor cassette.
Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
pH/Na+/K+/Ca++ or Cl– Sensor
Sensor needs deproteinizing and/or • Deproteinize the sensor.
conditioning. Deproteinizing the Sensors, page 67.
Note Any sensor might require • Condition the sensor.
deproteinizing, but only the glass
Conditioning the Sensors, page 68.
sensors (pH and Na+ sensors)
might require conditioning.

Bubbles in fill solution, or Debubble the sensor, or empty and refill.

insufficient or concentrated fill Refilling or Replacing the Measurement Sensors,
solution. page 80.
The problem might also be caused
by the reference sensor.
pCO2/pO2 Sensor
Sensor needs deproteinizing. Deproteinize the sensor.
Deproteinizing the Sensors, page 67.

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Troubleshooting

Possible Cause Action/Reference

Sensor failure. • Confirm failure by Measurement Block
routine.
Measurement Block Routine, page 130.
• Replace the sensor.
Refilling or Replacing the Measurement
Sensors, page 80.
Hct Sensor
Note The Hct sensor has no active layers/membranes, therefore it is very reliable.
Check for the following problems and carry out the actions shown. If these are
unsuccessful, replace the sensor.
Dampness around the sensor • Dry off measurement block, contacts, and
sensor.
• Check sensor O-ring seal and replace if
necessary.
• Ensure that sensors are seated properly, and
the tensioner is pushed firmly home.
Refilling or Replacing the Measurement
Sensors, page 80.
Insufficient reagent/wash delivery. Ensure that the reagents/wash bottles contain
sufficient solution.
Checking the Reagents, page 65.
Bubbles in sensor or sample path. • Ensure that the reagent pump tubing is
tensioned.
• Ensure that the measurement block tube is
connected to the pump tubing.
• Replace the pump tubing.
Changing the Pump Tubing, page 75.
• Check pre-heater assembly tubing. Replace
pre-heater assembly.
Replacing the Pre-heater Tube, page 98.
Poor measurement block washout, • Ensure that pump tubing is tensioned.
no or insufficient "pull" on sample • Ensure that measurement block tube is
line. connected to the pump tubing.
• Replace the pump tubing.
Changing the Pump Tubing, page 75.
Sensor needs deproteinizing. Deproteinize the sensor.
Deproteinizing the Sensors, page 67.

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Troubleshooting

Possible Cause Action/Reference

Unsuccessful slope. • Carry out calibration routine and slope, using
a fresh slope ampule.
• Repeat calibration routine and slope at least
twice more, using a fresh slope ampule on
each occasion.
Sensor failure. • Confirm failure by Measurement Block
routine.
Measurement Block Routine, page 130.
• Replace the sensor.
Refilling or Replacing the Measurement
Sensors, page 80.
System
Dampness around the sensor. • Dry off measurement block, contacts, and
sensor.
• Check sensor O-ring seal and replace if
necessary.
• Ensure that sensors are seated properly, and
the tensioner is pushed firmly home.
Refilling or Replacing the Measurement
Sensors, page 80.
Partial blockage in sensors. Clear the blockage.
Clearing Blockages, page 101.
Gas cartridges connected incorrectly • Ensure that cartridges are connected
or gas flow rate incorrect. correctly and installed in correct position.
Changing the Gas Cartridges, page 72.
• Check gas flow rate.
Checking the Gas Flow Rate, page 74.
Bubble in sample path - specifically • Repeat the measurement.
under the reference sensor. • Watch the solution being aspirated to
determine the cause of the bubble.
Very occasionally, worn pump Replace the pump tubing.
tubing may cause instability on one Changing the Pump Tubing, page 75.
or more channels.
Very occasionally, dampness around Carefully clean and dry the affected areas.
the pre-heater, or at the insulating
bushes at either end of the sample
path may cause instability.

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Calibration or Slope Outside Range

Possible Cause Action/Reference
Reference Sensor (pH/Electrolyte Drift)
Bubble in the reference sensor. Debubble the sensor.
Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
Nafion inner electrode is dry due to Replace Nafion inner electrode if dry, or refit it
a large bubble, or is not screwed correctly.
down properly, or fits poorly. Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
Sensor is clogged with crystals Empty the sensor cassette and refill carefully with
caused by poor filling, or bubbles reference sensor fill solution.
creating crystal growth. Replacing the Reference Sensor Cassette or Inner
Note This applies only to the Electrode, page 83.
reference sensor.
Vent hole is blocked. Unblock the vent hole in the reservoir cap.
Clearing Blockages, page 101.
Failed or leaking membrane. Replace the sensor cassette.
Replacing the Reference Sensor Cassette or Inner
Electrode, page 83.
pH/Na+/K+/Ca++ or Cl– Sensor
Sensors fitted incorrectly. Verify that sensors are in the correct position.
Bubbles in fill solution, or Debubble the sensor, or empty and refill.
insufficient or concentrated fill Refilling or Replacing the Measurement Sensors,
solution. page 80.
The problem might also be caused
by the reference sensor.
Sensor failure. • Confirm failure by Measurement Block
routine.
Measurement Block Routine, page 130.
• Replace the sensor.
Refilling or Replacing the Measurement
Sensors, page 80.
Sensor needs conditioning (pH and Condition the sensor.
Na+ sensors only). Conditioning the Sensors, page 68.
Sensor needs deproteinizing. Deproteinize the sensor.
Deproteinizing the Sensors, page 67.

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Possible Cause Action/Reference

pCO2 /pO2 Sensor
Sensor needs deproteinizing. Deproteinize the sensor.
Deproteinizing the Sensors, page 67.
Sensor failure. • Confirm failure by Measurement Block
routine.
Measurement Block Routine, page 130.
• Replace the sensor.
Refilling or Replacing the Measurement
Sensors, page 80.
Hct Sensor
Note The Hct sensor has no active layers/membranes, therefore it is very reliable.
Check for the following problems and carry out the actions shown. If these are
unsuccessful, replace the sensor.
Dampness around the sensor • Dry off measurement block, contacts, and
sensor.
• Check sensor O-ring seal and replace if
necessary.
• Ensure that sensors are seated properly, and
the tensioner is pushed firmly home.
Refilling or Replacing the Measurement
Sensors, page 80.
Insufficient reagent/wash delivery. Ensure that the reagents/wash bottles contain
sufficient solution.
Checking the Reagents, page 65.
Bubbles in sensor or sample path. • Ensure that the reagent pump tubing is
tensioned.
• Ensure that the measurement block tube is
connected to the pump tubing.
• Replace the pump tubing.
Changing the Pump Tubing, page 75.
• Check pre-heater assembly tubing. Replace
pre-heater assembly.
Replacing the Pre-heater Tube, page 98.

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Troubleshooting

Possible Cause Action/Reference

Poor measurement block washout, • Ensure that pump tubing is tensioned.
no or insufficient "pull" on sample • Ensure that measurement block tube is
line. connected to the pump tubing.
• Replace the pump tubing.
Changing the Pump Tubing, page 75.
Sensor needs deproteinizing. Deproteinize the sensor.
Deproteinizing the Sensors, page 67.
Unsuccessful slope. • Carry out calibration routine and slope using
a fresh slope ampule.
• Repeat calibration routine and slope at least
twice more, using a fresh slope ampule on
each occasion.
Sensor failure. • Confirm the failure by using the
Measurement Block routine.
Measurement Block Routine, page 130.
• Replace the sensor.
Refilling or Replacing the Measurement
Sensors, page 80.
System
Dampness around the sensor • Dry off measurement block, contacts, and
sensor.
–OR– • Check sensor O-ring seal and replace if
necessary.
• Ensure that sensors are seated properly, and
Measurement block assembly and
the tensioner is pushed firmly home.
sensors are wet.
Refilling or Replacing the Measurement
Sensors, page 80.
Worn pump tubing. Replace the pump tubing.
Changing the Pump Tubing, page 75.
Gas cartridges are connected • Ensure that cartridges are connected
incorrectly or gas flow rate is correctly and installed in correct position.
incorrect. Changing the Gas Cartridges, page 72.
• Check gas flow rate.
Checking the Gas Flow Rate, page 74

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Fluidics Failure
Possible Cause Action/Reference
Reagents
Buffer or wash bottles are empty. Replace buffers or wash bottles.
Emptying the Waste Bottle, page 64 also
describes how to handle and reuse the empty
wash bottle.
Bottle tubes do not reach the solution. Feed the tubes through the connector caps into
the solutions.
Checking the Reagents, page 65.
System
Blockage in the sample path. Clear the blockage.
Clearing Blockages, page 101.
Leaks in sample path. • Fix all leaks.
• Check sensor O-ring seals and make sure
sensors are seated correctly and the
sensor tensioner is pushed firmly home.
Check probe connector O-rings and
replace if necessary.
Refilling or Replacing the Measurement
Sensors, page 80.
Replacing the Reference Sensor Cassette
or Inner Electrode, page 83 .
Replacing the Probe and Tubing and
Probe Housing, page 92.
Aspirating air on calibrant or sample Fix the leak.
line.
New/greasy probe. 1. Raise probe lever and immerse tip of probe
in a strong soap solution for 10 to 15
seconds.
2. Lower the probe lever and prime the
system.
Using the Prime Routine, page 71.
Damaged seal in probe sleeve caused by Replace probe and housing.
bent probe Replacing the Probe and Tubing and Probe
Housing, page 92.

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Troubleshooting

Possible Cause Action/Reference

Pump Tubing
Insufficient “pull” on calibrant line. 1. Check that the reagent pump tubing is
tensioned.
2. Check that the rubber connector is pushed
firmly onto manifold.
3. Replace the tubing.
Changing the Pump Tubing, page 75.
Tubing is blocked. • Clear the blockage.
Clearing Blockages, page 101.
• If fault persists replace the tubing.
Changing the Pump Tubing, page 75.
Mechanical
Pump rollers are dirty. Remove pump rollers, clean, grease and re-
assemble.
Cleaning the Rollers, page 77.
Probe is misaligned. Realign or replace probe.
Replacing the Probe and Tubing and Probe
Housing, page 92.
Solenoid(s) inoperative. Contact your local technical provider or
distributor. See Appendix B, Warranty and
Support Information.
Fluid Detector
Sample detector cover not fitted. • Fit the cover properly.
Replacing the Pre-heater Tube, page 98.
Ambient light affecting fluid detector. • Position system out of direct sunlight.
Dirty tubing. • Replace probe tubing and measurement
block tube.
Changing the Pump Tubing, page 75.
Detector failure. • Confirm failure using the Sample Flow
routine, page 134.
• Replace detector.
See replacement instructions on the
detector packaging.

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Suspect Patient Results

Note Suspect results: Results that in your professional judgment seem
unlikely. These can be caused by a poorly maintained reference sensor (for
example, protein build up on the reference sensor membrane), bubbles in
the fill solution, or crystal growth. Under these conditions aqueous
solutions (for example, QC material) diffuse across the reference sensor
membrane at a different rate from non-aqueous solutions (for example,
patient samples), and therefore QC results might not be affected.

General Procedure When Suspect Patient Results Occur

If the system reports patient results that seem suspect, perform the
following procedures:
1. Deproteinize the sample path.
2. Debubble the reference sensor and remove the bubbles.
3. Remove any crystals in the reference sensor.
4. Empty the sensor cassette.
5. Refill carefully with reference sensor fill solution.
6. If the problem still exists, replace the reference sensor cassette.
See Replacing the Reference Sensor Cassette or Inner Electrode, page
83.

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Troubleshooting

Suspect Results, Possible Causes and Corrective Actions

Possible Cause Action/Reference
Reference Sensor
Bubble in the reference sensor. Debubble the sensor.
Replacing the Reference Sensor Cassette or
Inner Electrode, page 83.
Crystals in the bottom of the reference 1. Remove any crystals in the reference sensor.
sensor. 2. Empty the sensor cassette.
Note Crystal growth occurs only in the 3. Refill carefully with reference sensor fill
reference sensor. solution.
4. If the problem still exists, replace the
reference sensor cassette.
Replacing the Reference Sensor Cassette or
Inner Electrode, page 83.
Possible Cause Action/Reference
Failed or leaking membrane. Replace the reference sensor cassette.
Replacing the Reference Sensor Cassette or
Inner Electrode, page 83.
System
Ca++ or Cl– sensor installed, incorrect Select correct measured parameters.
sensor selected. Selecting Measurement Parameters, page 155.
Correlation factors changed. Reset to the correct factors
Adjusting Correlation, page 152.
Calibrants used for longer than 21 days. Replace the Buffer Pack
Checking the Reagents, page 65.
Sample creep caused by a blockage Clear the blockage
(for example, a fibrin clot in the sample Clearing Blockages, page 101.
path).
Bubbles in the sensor fill solution. Debubble the sensors.
Deproteinizing the Sensors, page 67.
Sample
Sample improperly collected or stored. • Obtain a fresh sample.
• Analyze sample as soon as possible after
collection. See Handling and Storing
Samples, page 28.
• Store unused sample properly.

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Troubleshooting

Possible Cause Action/Reference

QC
Problem could be caused by: • Use only recommended QC materials.
• abnormal pH • Handle QC materials properly.
• interfering ions Handling QC Samples, page 55.
• wrong matrix • Verify that the settings and solutions you
• wrong assigned values are using are correct.
• use of other aqueous standards • If the problem is interfering ions, run the
deproteinizing routine. Deproteinizing the
• improper handling
Sensors, page 67.
Note If you encounter any of these issues while using Siemens QC samples, make sure
that the operating and system settings are correct. If a QC sample results are within the
measurement range, you should not encounter a problem with an abnormal pH.
Capillary Samples
Small bubbles that are not detected. Take care when aspirating capillary samples.
No sample in measurement block • Reposition sample.
• Sample not detected, or sampling • Repeat sample measurement.
fault (system)
• Fluid detector issues
False “sampling complete” or “micro Clear blockages in drip tray/manifold/pump
sample” indications. tubing.
Segments of Wash solution in sample Clearing Blockages, page 101.
path causing false 'sampling complete' or
'micro sample' indications
• Sample not detected, or sampling
fault

Sample Not Detected or Sampling Faults

Possible Cause Action/Reference
Pump Tubing
No or insufficient “pull” on the 1. Verify that the pump tubing is tensioned.
sample line. 2. Verify that the measurement block tube is
connected to the pump tubing.
3. Replace the pump tubing.
Changing the Pump Tubing and Cleaning
and Lubricating the Rollers, page 75.

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Troubleshooting

Possible Cause Action/Reference

System
No sample in the measurement Repeat the sample measurement.
block.
Blockage in the sample path. Clear the blockage.
Clearing Blockages, page 101.
Segments of wash solution in the • Check for blockages in the drip tray,
sample path are causing false manifold, or pump tubing.
sampling complete or micro sample • Clear any existing blockage.
indications.
Clearing Blockages, page 101.
Leaks in the sample path. • Fix all leaks.
• Check sensor O-ring seals.
• Make sure sensors are seated correctly and
the sensor tensioner is pushed firmly home.
• Check the probe connector
O-rings and replace if necessary.
Refilling or Replacing the Measurement
Sensors, page 80.
Replacing the Reference Sensor Cassette or
Inner Electrode, page 83 .
Replacing the Probe and Tubing and Probe
Housing, page 92.
Aspirating air on the sample line. Fix the leak.
Fluid Detector
Sample detector cover not fitted. Fit the cover properly.
Replacing the Pre-heater Tube, page 98.
Ambient light affecting fluid Position system out of direct sunlight.
detector.
Dirty tubing. Replace the probe tubing and the measurement
block tube.
Replacing the Probe and Tubing and Probe
Housing, page 92.
Changing the Pump Tubing, page 75.
Detector failure. • Confirm failure by using the Sample Flow
routine, page 134.
• Replace the failed detector.
See replacement instructions on detector
packaging.

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Troubleshooting

Printer Issues
Possible Cause Action/Reference
No printout
Printer is turned off or options not Verify that the printer is turned on and the
selected. appropriate options are selected in Ready >
Settings > Operating Setup > Printer Options.
Paper loaded incorrectly. Load paper correctly.
Replacing the Printer Paper, page 90.
Printer failure. • Confirm failure by running the Roll Printer
routine.
Roll Printer Routine, page 136.
• Contact your local technical provider or
distributor. See Appendix B, Warranty and
Support Information.
Paper jammed. Fix paper jam.
Replacing the Printer Paper, page 90.

Heater Failure
If the display shows Heater Failed, the system does not allow calibrations
or sample measurements. Perform the following procedures:
1. Use the Heater routine, page 135, to determine which heater has
failed.
The system has 2 heater systems: a Sensor Block Heater to maintain the
sensor block at 37°C, and a Pre-heater to preheat samples and reagents
to 37°C.
2. Contact your local technical provider or distributor.

Using the Troubleshooting Routines

1. Select Ready > Settings > Troubleshooting.
2. Select the troubleshooting routine that you want to perform.

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Troubleshooting

Measurement Block Routine

The Measurement Block routine measures and displays the sensor output
in mV or pA. By comparing the readings to the values given, you can see if
the sensors require maintenance, or if they should be replaced. You can
also use this routine (running 7.3 or 6.8 buffer) to help diagnose fluidics
failures.
Note Channels that have been auto deselected are still measured and
displayed in this routine.
1. Select Ready > Settings > Troubleshooting > Measurement Block.
2. Select the buffer or gas test you want to run.
The system displays the measurement in mV/pA.

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Troubleshooting

3. Compare the mV/pA readings with these values1 :

pH 7.3 Buffer pH (mV) 6.8 Buffer pH (mV)

Nominal mV +300.0 +330.0
Total pull in range 194.0 to 406.0 23.1 to 38.0 above
7.3 buffer mV value
Action limits < 270.0 or > 330.0 < 27 or > 35 above
Na+ 7.3 Buffer Na+ (mV) 6.8 Buffer Na+ (mV)
Nominal mV +80.0 +74.0
Total pull in range 29.0 to 126.0 -4.4 to -7.2 below
7.3 buffer mV value
Action limits < 50.0 or > 90.0 < 4.8 or > 6.8 below
7.3 buffer mV value
K+ 7.3 Buffer K+ (mV) 6.8 Buffer K+ (mV)
Nominal mV +80.0 +97.0
Total pull in range 29.0 to 126.0 12.8 to 21.0 above
7.3 buffer mV value
Action limits < 50.0 or > 90.0 < 16.0 or > 19.5 above
7.3 buffer mV value
Ca++ 7.3 Buffer Ca++ 6.8 Buffer Ca++ (mV)
Nominal mV +80.0 +89.3
Total pull in range 29.0 to 126.0 5.7 to 11.1 above
7.3 buffer mV value
Action limits < 55.0 or > 105.0 < 6.6 or > 10.2 above
7.3 buffer mV value
Cl– 7.3 Buffer Cl– (mV) 6.8 Buffer Cl– (mV)
Nominal mV +80.0 +89.5
Total pull in range 29.0 to 126.0 6.6 to 10.6 above
7.3 buffer mV value
Action limits < 70.0 or > 110.0 < 8.0 or > 9.5 above
7.3 buffer mV value
Hct 7.3 Buffer Hct (mV) Hct Slope (mV)
Nominal mV +3.50 +6.15
Total pull in range -1.05 to 7.35 4.96 to 7.07 above
7.3 buffer mV value
pCO2 Cal Gas pCO2 (mV) Slope Gas pCO2 (mV)
Nominal mV -170.0 -151.0

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Troubleshooting

Total pull in range -300.0 to +100.0 12.8 to 20.6 above cal

gas mV value
Action limits < -270.0 or > +80.0 < 13.5 or > 20.2 above
cal gas mV value
pO2 Cal Gas pO2, (pA) Slope Gas pO2, (pA)
Nominal pA +764.0 +10.0
Total pull in range 171 to 1711 above -100.0 to +200.0
slope gas pA value
Action limits < 300 or > 1400 above < -50 or > 150
slope gas pA value
Action pH/Na+/K+/Ca++/Cl–: this might be caused by the
reference sensor, see page 83 and following. If
problems persist, deproteinize, condition or
refill the sensor. If the problem is still apparent,
replace the sensor. See Deproteinizing the
Sensors, page 67 or Replacing the Reference
Sensor Cassette or Inner Electrode, page 83.
pCO2/pO2: Replace the sensor. See Replacing
the Reference Sensor Cassette or Inner
Electrode, page 83.

Stability: For 7.3 Buffer and Cal Gas, a typical sensor shows the
following performance:

pH Na+ K+
Noise: After 15 0.12 mV/10 sec 0.18 mV/10 sec 0.13 mV/10 sec
seconds, the display
does not change by
more than the
values shown in this
row.
Drift: After 15 0.13 mV 0.18 mV 0.13 mV
seconds the display
does not change
unidirectionally by
more than this value
during the
remainder of the
measurement.

1. at 760 mmHg atmospheric pressure.

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Troubleshooting

Ca++ Cl– Hct

Noise: After 15 0.1 mV/10 sec 0.25 mV/10 sec 00.95 mV/10 sec
seconds the display
does not change by
more than the
values shown in this
row.
Drift: After 15 0.1 mV 0.25 mV 0.05 mV
seconds the display
does not change
unidirectionally by
more than this value
during the
remainder of the
measurement.

pCO2 pO2
Noise: After 15 0.14 mV/10 sec 1.1 pA/10 sec
seconds the display
does not change by
more than the
values shown in this
row.
Drift: After 15 0.14 mV 3.4 pA
seconds the display
does not change
unidirectionally by
more than this value
during the
remainder of the
measurement.

Instability on the pH/Na+/K+/Ca++/Cl– channel might be caused by the

reference sensor. De-bubble the reference sensor and repeat the test.
4. Select Cancel to cancel the test.
Note If the error message: pO2 offset cal required is printed, contact
your local technical provider or distributor.

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Troubleshooting

Run Test Sample

Use the Run Test Sample routine to:
• Measure a sample with a known mV value (for example, run 7.3 or 6.8
buffer as a sample).
• Run Hct slope.
Note You cannot use capillary samples with the Run Test Sample routine.

Sample Flow Routine

The Sample Flow routine checks the sample pathway from probe to waste
bottle. It also checks the fluid detectors.
1. Select Ready (or Not Ready) > Settings > Troubleshooting > Sample
Flow.
2. Lift the probe to test sample flow.
3. Present a test sample (for example, a QC sample).
4. To start the sampling, select Start.
5. Watch the sample as it goes through the pre-heater.
6. When the sample reaches the first fluid detector, verify that the FD1
box on the display changes from white to black (Figure 55 ).
If the system detects no fluid, the boxes remain white.

Figure 55: Location of Fluid Detectors

1. Fluid Detector 1 (FD1)

2. Fluid Detector 2 (FD2)

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Troubleshooting

7. Watch the sample as it goes through the measurement block.

8. When the sample reaches the second fluid detector, verify that the FD2
box on the display changes from white to black.
9. After the sample reaches the detectors, remove the sample from the
probe.
10. Watch the trailing edge of the sample as it goes through the pre-
heater.
11. When the trailing edge of the sample reaches the first fluid detector,
verify that the FD1 box on the display changes from black to white.
12. Watch the trailing edge as it goes through the measurement block.
13. When the trailing edge reaches the second fluid detector, verify that
the FD2 box on the display changes from black to white.
14. To repeat the test, present the sample again and remove it.
15. Close the probe to cancel the test.
16. If either of the fluid detectors fails the test, replace it according to the
instructions on the packaging.
Note After 1 minute of system inactivity, the system beeps twice every
few seconds until you close the probe.
17. If no sample is in the measurement block at the time of the test, you
might see a fluid detector issue:
a. Reposition the sample.
b. Repeat the sample measurement.

Heater Routine
The Heater routine displays the system temperature, the temperature of
the pre-heater and the temperature of the sensors.
1. Select Ready (or Not Ready) > Settings > Troubleshooting > Heater.
If the temperature is outside specification, the system displays
Warming up or Heater failed.
2. If Warming up is constantly displayed, or if Heater failed is displayed,
contact your local technical provider or distributor.

Electronics Routine
The Electronics routine checks the system’s electronic functions:
• Electronics 1 (system RAM tests)

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Troubleshooting

• Electronics 2 (ADC, voltage reference buffer, voltage offset DAC, motor

DAC, comparitor port)
• Electronics 3 (display RAM) Heater
• BP sensor
• Probe
• Real time clock
• Fluid detectors
To run the Electronics routine, perform the following steps:
1. Select Ready (or Not Ready) > Settings > Troubleshooting >
Electronics.
• When the system completes this routine, it confirms that the
testing was successful.
• If a test fails three attempts, the system displays the test name and
a failed message.
2. Contact your local technical provider or distributor if any electronics
test fails.

Roll Printer Routine

The Roll Printer routine checks the internal printer.
1. Select Ready (or Not Ready) > Settings > Troubleshooting > Roll
Printer.
The printer prints the following test set:

12345678901234567890123456789012
34567890123456789012345678901234
56789012345678901234567890123456
78901234567890123456789012345678
90123456789012345678901234567890
--------------------------------
2. If the system does not print the test set, verify that the printer is on,
that you have loaded the paper correctly and that the paper is not
jammed. See page 90.
3. If the system still does not print, contact your local technical provider or
distributor.

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Troubleshooting

Sensors Routine
The Sensors routine reports up to 4 calibration faults, in the following
priority:

Sensors: pH
pCO2
pO2
Na+
K+
Ca++
Cl–
Hct
Faults: no endpoint, drift, outside range

1. Select Ready (or Not Ready) > Settings > Troubleshooting> Sensors.
Follow the appropriate troubleshooting routines. See page 111 and
following.

Other Problems
Indicator Possible Cause
Maintenance or • Prompts are not set. See Setting the Maintenance
QC prompts do Prompts, page 154 and QC Prompts Setup, page
not appear 150.
No data shown • Parameter is not selected. See Selecting
for measured Measurement Parameters, page 155.
parameters, on • Parameter is selected, but has failed calibration,
display or and is not available for sample/QC measurement.
printout
No data shown • The display shows a maximum of 8 parameters,
for calculated but all selected parameters are printed.
parameters, on • Parameter is not selected. See Selecting
display or Calculated Parameters, page 155
printout
• Parameter is selected, but appropriate
measurement channels are not selected, or are
not available; or ctHb and FIO2 are not available.
Automatic micro Insufficient sample (minimum 50 μL).
sample mode
not available

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Troubleshooting

Indicator Possible Cause

Hct Slope Hct slope prompt has been displayed for more than
Overdue is 24 hours.
printed
QC Overdue is More than one QC prompt has become due.
printed
Beeper sounds • Entry field is full, and number key pressed.
during data • Entry field is empty and Cancel key pressed.
entry
• Data entered is invalid.
Beeper sounds • At start of records and you select Back.
during sample or • At end of records and you select Next.
QC data recall
Atmospheric • Entered value differs from the displayed value by
pressure cannot more than ±20 mmHg.
be changed • BP sensor is faulty. Contact your local technical
provider or distributor.

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9 Data Management

• Managing Sample Data, page 139

• Managing QC Data, page 139
• Managing Calibration Summary Data, page 139

Managing Sample Data

The system retains the data for the last 250 samples measured. Using the
Data Recall menu, you can perform the following functions:
• Recall data for each of the last 250 samples.
• Enter or change patient data for each recalled sample.
• Print the results for each recalled sample.
See Recalling Sample Data, page 45 for a detailed process description.

Managing QC Data
The system retains the data for the last 90 QC samples measured for each
QC level.
Statistics are calculated for Levels 1–3, and Hct Level A and B. Level X has
no statistical data for Level X, because it has no range checking.
Use the Data Recall menu to perform the following functions:
• Print statistical data for Levels 1–3 and Hct Levels A and B.
• Recall data for each QC sample.
• Reassign QC data to another level.
• Print results for each QC sample to be printed.
See Recalling and Printing QC Data, page 57 for a detailed process
description.

Managing Calibration Summary Data

The system maintains a calibration summary for all calibrations within a
24-hour period.
If you select Cal Summary (see Setting Printer Options, page 151), the
system automatically prints the summary every day at the end of the first
calibration after 6 A.M.

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Data Management

Use the Data Recall menu to manually initiate a calibration summary

printout. See Recalling and Printing Calibration Data, page 52 for a
detailed process description.

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10 System Installation and Configuration

You can use the system with the default (factory set) options and values,
but there are several setup options available that let you customize the
system for your laboratory. Where applicable, we have recommended
settings.
• Installation, page 141
• Environmental Requirements, page 142
• Installation Procedure, page 142
• Installing the Barcode Reader, page 147
• Installing a USB Memory Stick, page 149
• Powering-Up the System, page 149
• Configuring Operating Setup, page 149
• Configuring System Setup, page 154
• Service Setup, page 158

Installation
Your system should be installed by an authorized Siemens representative.

CAUTION
The electromagnetic environment should be evaluated prior to operation
of the device. Do not use this device in close proximity to sources of
strong electromagnetic radiation (e.g., unshielded intentional RF
sources), as these can interfere with the proper operation. This
equipment complies with the emission and immunity requirements of
the IEC 61326 series.

CAUTION
Use the following procedure to install your system only if you are located
in a region where Siemens Field Service Representatives do not perform
installation.

After the system is installed, see Configuring Operating Setup, page 149
and the sections that follow for information about configuring the system.

RAPIDLab 348EX Operator’s Guide page 141

System Installation and Configuration

Environmental Requirements
1. Place the system on a level surface and do not expose it to direct
sunlight.
2. Ensure that the power connector and switch on the back panel are
accessible.
See Appendix F, Specifications, for information about the physical
dimensions, power requirements, and other physical and environmental
specifications for the system.

Installation Procedure
For detailed figures, refer to Section 7, Maintenance.
1. Inspect the packing case and report any damage to the shipper. If you
find any problems, notify your Siemens representative at installation.
2. Unpack the starter kit and check against the following list:
Description Qty SMNa Catalog Article
Number Number
Buffer pack 1 10309757 104227 01410308
Wash pack 1 10309756 104226 02490356
–OR–
Wash pack (Japan 1 10329872 106370 09349799
only)
pH sensor 1 10312556 476267 07173251
pCO2 sensor 1 10317498 476247 02671199
pO2 sensor 1 10324408 476246 06462640
Na+ sensor 1 10312557 476266 09463893
K+ sensor 1 10327404 476270 09792935
Hct sensor 1 10309783 106042 06553743
Reference Sensor 1 10323084 476273 05719400
Deproteinizer 1 10309775 105610 08915030
(10-pack)
Hct Slope 1 10309776 105670 06990590
(10-pack)
Ca++/Cl– sensor blank 1 10311665 673702 00768594
(TB3)

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Description Qty SMNa Catalog Article

Number Number
–OR– (if ordered)
one of the following
sensors:
Ca++ Sensor 1 10315922 476268 00061776
Cl– Sensor 1 10330133 476279 00183065
a. Siemens Materials Number

WARNING
The system weighs 9.4 kg (20.7 lb). Observe safe lifting precautions.

3. Remove the system from the carton and place it on the work surface,
with the back panel accessible.
4. If necessary, connect a suitable connector to the power supply cord.
5. Follow the connector manufacturer's instructions.
6. Insert the power supply cord into the power connector on the back
panel.

CAUTION
Do not connect the power supply cord to the power supply.

Installing the Measurement Sensors

1. Ensure that the level of fill solution in the pH and K+ (and Ca++ or Cl–, if
installing) sensors is full, with a small air space at the top.
Note The Hct sensor does not require filling.
2. Ensure that the Na+ sensor is completely full, with no air space.
a. If necessary, empty and refill the sensors, making sure you use the
correct fill solution.
b. Follow the instructions on the fill solution pack.
c. Make sure that no air bubbles are trapped in the bottom of the
sensor.
d. See Refilling or Replacing the Measurement Sensors, page 80.
Note The gas sensors are sealed and cannot be refilled.
3. Raise the front cover.
4. Slide the measurement block catch down and raise the block door.

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5. Insert the sensors in the following order:

a. pO2
b. pCO2
c. Hct
d. Na+
e. K+
f. Ca++ or Cl– or blank
g. pH

CAUTION
If you install a Ca++ or Cl– sensor, you must select the appropriate
measured parameter. See Selecting Measurement Parameters, page 155.

6. Slide the sensors into place, making sure that the sensor contacts align
with the contacts in the block.

Installing the Reference Sensor

1. Refer to the reference sensor package insert for filling instructions.

CAUTION
• Make sure no air bubbles are trapped in the left chamber of the
sensor cassette, immediately above the sample pathway.
• Do not overfill the right reservoir chamber.

2. Swing the block tensioner to the right and press the tensioner lock
button to hold the tensioner in the open position.
3. Insert the reference sensor and push the bottom of the sensor to click it
into place.
4. Make sure all the sensors are seated correctly, then hold the tensioner
and press the tensioner lock button.
5. Gently release the tensioner and push it firmly home to make a good
seal.
6. Lower the block door, snapping it into place.

Connecting the Pump Tubing

1. Tension the sample pump tubes (left pump) by pulling the tube lugs
under the tensioners.
2. Connect the sample tube to the measurement block tube, and the
waste tube to the manifold.

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3. Connect the rubber connector to the manifold.

4. Tension the reagent pump tubes (right pump) by pulling the tube lugs
under the tensioners.
5. Connect the rubber waste cap connector to the manifold.
6. Make sure that the pump tubing is not pinched.
7. Date the pump tubing labels a maximum of 3 months ahead.

Installing the Reagents

1. Remove the caps from the 6.8 and 7.3 buffer bottles.
2. Insert the tubing connectors into the bottles and push the caps onto
the bottles.
3. Place the bottle assembly in the left side of the reagent compartment
feeding the tubes through the caps into the solutions.
4. Date the buffer pack label a maximum of 21 days ahead.
5. Remove the User Action Pack from the neck of a Wash bottle and
remove the bottle cap.
6. Insert the tubing connectors into the bottle and push the cap onto the
bottle.
7. Place the bottle to the right of the buffer bottles feeding the tube
through the cap into the solution.
8. Verify that the waste bottle is in position.
9. Verify that the neck of the waste bottle is correctly positioned
underneath the rubber cap, with the waste cap spout inside the neck of
the waste bottle.

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Installing the Gas Cartridges

CAUTION
Use only Siemens gas cartridges supplied for use with the system, as they
have been designed for ease of use and optimum performance. Siemens
assumes no liability for performance if cartridges other than those
specified for use with the system are used.

WARNING
Compressed gas cartridges require careful handling. To prevent damage
and possible personal injury, observe the following precautions:
• Never install other gases, for example, propane cartridges.
• Never drop cartridges, allow them to strike each other or subject them
to other strong shocks.
• Never tamper with the cartridge valves.
• Use these gases for the calibration of clinical and research
instrumentation only. US Law prohibits dispensing these gases for
drug use.
• The contents are under pressure—do not puncture.
• Do not use or store near heat or open flame.
• Do not expose cartridges to temperatures above 54°C (130°F), as this
might cause the contents to vent or explode.
• Never throw cartridges into fire or incinerators. Dispose of the
cartridges according to your laboratory protocol.

CAUTION
The cartridges and cartridge compartment are clearly marked and color
coded:
• Gas 1 (blue)
• Gas 2 (black)
Ensure that the cartridges are installed in the correct position.

1. Remove the plastic protective cap from the cartridge valve.

2. Slide the cartridge into the compartment, and then gently push and
turn the cartridge clockwise to engage it with the regulator.
3. Screw the cartridge in until finger tight.

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Note The gas regulator assembly is designed to make a good seal by

finger tightening only. Do not overtighten the cartridges, either by
using tools or by applying excessive force.
4. Lower the front cover.

Installing the Barcode Reader

The barcode reader requires no configuration before use.

Physical Installation
1. Connect the external barcode reader to the system through the USB
port to enter patient ID data and Operator ID.
2. Attach the barcode reader bracket to the left or right side of the
system.
3. Position the bracket so that you can comfortably use the scanner in one
of the following ways:
• Hand-held operation: you bring the scanner to the sample.
• Fixed-position in the bracket: you bring the sample to the scanner.
4. When using the barcode reader, be sure to observe the safety
precautions described in Protecting Yourself from the Barcode Reader
Beam, page 22.

Setting the Barcode Reading Mode

In the default standard mode, you pull the trigger to read a barcode.
In presentation mode, the reader automatically reads any barcode in its
field of view. In this mode, you can leave the reader on its bracket and pass
the barcode in front of it.
To set the reader to presentation mode, scan the following barcode:

Figure 56: Presentation Mode Barcode

To reset the device to standard mode, scan the following barcode:

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Figure 57: Standard Mode Barcode

To enable or disable Interleaved 2 of 5, scan the appropriate barcode

below.

Figure 58: Enable Interleaved 2 of 5

Figure 59: Disable Interleaved 2 of 5

To enable or disable Codabar, scan the appropriate barcode below.

Figure 60: Enable Codabar

Figure 61: Disable Codabar

To enable or disable MicroPDF417, scan the appropriate barcode below.

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Figure 62: Enable MicroPDF417

Figure 63: Disable MicroPDF417

Installing a USB Memory Stick

You can insert a USB memory stick into a USB port; for example, to install
software.

Powering-Up the System

For information about powering up the system, see page 33. After the
system completes its warmup, continue with the following steps to
configure the system.

Configuring Operating Setup

Note When you have configured the system, print the setup report,
page 157, so you have a record of the selected options.
1. Select Ready > Settings > Operating Setup.
2. Select the function that you want to set up.
Note The setup for dialysis fluid mode is the same as for blood gas mode,
except that dialysis fluid mode has no reference ranges.

QC Ranges Setup
You can set QC ranges for 3 levels of QC and 2 levels of Hct QC. Level X has
no ranges. If a QC measurement is outside these ranges a result is flagged
on the display and on the printout.

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You can set the system to prompt you via the Action List to run QC
samples. The QC prompts appear at the times you select. Up to 3 prompts
can be set. If a QC sample is prompted and is not run before the next
prompt is due, subsequent sample results are flagged on the printout.
Default setting: instrument measurement range.
1. Select Ready > Settings > Operating Setup > QC Setup.
2. Select the QC level, then enter the lot number and ranges given in the
QC product insert.

CAUTION
Changing QC lot clears the data file for that QC level. We recommend that
you print the QC statistics (see page 57) before changing the lot.

The maximum QC range that can be entered is the instrument

measurement range.

QC Prompts Setup
Default setting: no QC prompts set.
1. Select Ready > Settings > Operating Setup > QC Setup >
QC Prompts.
2. Select the field and enter the time, in 24-hour, hh:mm format, at which
you want each QC prompt to appear.
You can set one, two, or three prompts.
3. To cancel the prompts and clear the value, select C.

Setting Reference Ranges

You can set reference ranges for all measured parameters. If a sample
measurement is outside these ranges, the result is flagged on the display
and on the printout.
Individual reference values can vary according to a number of factors such
as age, posture, diet, exercise, and site of blood collection. We have taken
these factors into account when establishing the default values for the
system.
Default settings:

pH 7.350–7.450 (35.5–44.7 H+ nmol/L)6, 9, 11

pCO2 32.0–45.0 mmHg (4.27– 6.00 kPa)6-10
pO2 75–100 mmHg (10.00–13.33 kPa)6-8, 10

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Na+ 134–146 mmol/L6, 7, 9-11

K+ 3.40–4.50 mmol/L6-7
Ca++ 1.15–1.32 mmol/L12, 13
Cl– 96–108 mmol/L6-11
Hct 34–52%6, 7, 11

Each laboratory should establish its own reference ranges.

1. Select Ready > Settings > Operating Setup > Reference Ranges.
2. Select the parameters for which you want to set the range.
If you do not want to use the reference range facility, set the range to
the maximum instrument measurement range.
3. Enter the reference range for each selected parameter.
The maximum range that can be entered is the instrument
measurement range. See Measurement Range, page 191.
4. Select Ready > Settings > Operating Setup > Units.
5. Select the units that you want to use:
• pH units (default) or H+ nmol/L
• mmHg (default) or kPa for gases
• g/dL (default), g/L, or mmol/L for ctHb (entered and estimated).

Configuring Calibration
For information about configuring calibration timing (method and interval)
and gas values, see Selecting Calibration Method and Entering Gas Values,
page 49.

Setting Printer Options

1. Select Ready > Settings > Operating Setup > Printer Options.
2. Select the printer options:
• Turn the roll printer on (default) or off.
• Print results (default), calibrations, or calibration summary, or any
combination of these options.
• If you select cal summary, the system prints the cal summary at
approximately 6 A.M. each day.
• Print 1 (default), 2, or 3 copies of the sample report.
Note The number of copies option refers only to results. The system
prints all other data only once.

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Adjusting Correlation
The system is set during manufacture to give results that correlate with the
following values:

pH high precision pH system (Model R)

pCO2 and pO2 tonometered blood
Na+ and K+ flame photometry (480)
Ca++ ISE (634)
Cl– coulometry (925)
Hct microcentrifuge

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CAUTION
To change the values to correlate with other analyzers, you must use the
following procedure:
1. Reset the correlation factors in the system to:
pH, pCO2, pO2, Na+, K+, Ca++, Cl–, and Hct slope = 1.000
pH, pCO2, pO2, Na+, K+, Ca++, Cl–, and Hct intercept = 0.000
2. Use a large sample population covering the physiological range—
minimum 50 samples, preferably 100—to generate a random
distribution of values (not just normal values).
3. Make sure that the system and the reference analyzers are calibrated
following the manufacturer's instructions and are operating within
specifications.
4. Store samples at room temperature and measure them within 30
minutes of collection. Samples should be analyzed in duplicate on
both analyzers, with no more than 5 minutes between analysis on the
system and analysis on the reference analyzers.
5. Remove outliers from the data (means of duplicates values outside
±3SD, or duplicates that differ).
6. Perform a linear regression analysis. We recommend the Deming
method, which accounts for errors on both axes. Perform the linear
regression using a regression program on a calculator or computer.
The system should be treated as the dependent variable (Y-axis), or
the variable on the left side of the equation.
Note The X variable should be the reference analyzer.
7. The intercept and slope values obtained can then be entered using the
Correlation routine.
Note Values can be entered into the Correlation routine only in pH units
and mmHg. If you use H+ nmol/L or kPa for measurement, you must
convert these values into pH units and mmHg before entering.
• To convert from H+ nmol/L to pH: pH = 9.0 - log10(H nmol/L)
To convert to mmHg from kPa: mmHg = kPa x 7.50062

1. Select Ready > Settings > Operating Setup > Correlation.

To change dialysis fluid mode parameters, first select Ready > DF, so
that you see the message: Lift probe to analyze dialysis fluid.

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2. Enter the value or values that you want to change:

Parameter Value Default value for pH, pCO2, pO2, Na+, K+,
Ca++, and Cl–
slope 0.5–1.5 1.000
intercept ±5.000 0.000

Note Although you can change the correlation of other parameters on

the Dialysis Fluid Correlation screen, those values are not used for
any measurement purposes.

Configuring System Setup

To configure system setup functions, select Ready > Settings > System
Setup.

Changing Date and Time

1. Select Ready > Settings > System Setup > Date and Time.
The date and time of calibrations and measurements appear on the
printout. Changing the date and time clears the data held in the
calibration summary.
2. To keep a record of all calibrations, print the calibration summary,
page 52, before changing the date and time.
Default setting: Date and time set.

Setting the Maintenance Prompts

The system prompts you via the Action List to empty the waste bottle and
to deproteinize and condition the sensors. The prompts appear at
approximately 6 A.M. at the intervals you select.
1. Select Ready > Settings > System Setup > Maintenance Prompt.
• Waste bottle prompt, range: 0–9 days. Default: empty the waste
bottle every day.
• Deproteinize/condition prompt, range: 0–21 days. Default: every
14 days.
2. To cancel the prompts, enter 0 or select Cancel to clear the value.

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Selecting Measurement Parameters

1. Select Ready > Settings > System Setup > Parameters.
2. For blood gas mode, select parameters to measure by selecting
Measured and choose from the following options:
• pH
• pCO2
• pO2
• Na+
• K+
• CA++
• Cl–
• Hct

CAUTION
Do not select Ca++ or Cl– unless you have the appropriate sensor
installed. If you install either a Ca++ or Cl– sensor, make sure you select
the correct measured parameter.

Note By default, the pH, pCO2, pO2, Na+, K+ and Hct measurement
channels are selected. Ca++ and Cl– are not selected. The system does
not allow you to turn off all channels.
3. For dialysis fluid mode, select parameters to measure by selecting
Measured and choose from the following options:
• pH
• pCO2
• Na+
• K+
• Ca++

Selecting Calculated Parameters

Calculated parameters are displayed only if the appropriate measurement
channels are selected. By default, no calculated parameters are selected.
1. To select the acid/base parameters to calculate, select Ready >
Settings > System Setup > Parameters > Calculated (Acid-Base) and
choose from the following options:
• HCO3-act
• BE(ecf)

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• ctCO2
• AnGap
• HCO3-std
• BE(B)
• Ca++(7.4)
Note BE(ecf) was formerly BE(vv), and BE(B) was formerly BE(vt).
2. To select the oxygenation status parameters to calculate, select
Calculated (Oxygenation) and select from the following options:
• O2SAT
• ctHb (est)
• pO2(A-a)
• O2CT
• pO2/FIO2
• pO2(a/A)
Note pO2(A-a) was formerly A-aDO2, and pO2(a/A) was formerly
a/A ratio.
O2CT is displayed only if ctHb is entered, or ctHb(est) is available.
Parameters pO2(A-a), pO2(a/A) and pO2/FIO2 are displayed only if FIO2
is entered.

Turning the Beeper Off or On

1. Select Ready > Settings > System Setup > Beeper.
2. Select Beeper On (default) or Beeper Off.

Changing Communication Options

The system has 2 data ports. You can configure both ports to your
requirements. Port 2 supports only the LIS 1 protocol. See Appendix D,
Interfacing to External Devices for detailed information.
1. Select Ready > Settings > System Setup > Communications.
2. To set the protocol to use for Port 1, select Port 1 Protocol, then select
1 of the following options:
• LIS 1 (default)
• LIS 2
• LIS 3

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Note Selecting a different protocol for a port overwrites previous

selections.
3. To set the options for Port 1, select Port 1 Options, then select the
appropriate parameters:

Parameter Default Value

Baud rate 9600 baud
Stop bits 1 start bit, 8 data bits, 1 stop bit
Parity Off

4. To set the protocol to use for Port 2, select Port 2 Protocol, then select
LIS 1 as the protocol.
Note LIS 1 is the only acceptable protocol for Port 2.

Setting Security
Requiring an operator ID protects the measurement sequence. Password
protection guards against unauthorized or accidental changing of setup
options.
Even without entering a required password, you can do sample and QC
measurement, and the system calibrates as required. You can return to the
Ready screen without entering the password.
1. Select Ready > Settings > System Setup > Security.
2. Select Menu Password.
3. Enter a menu password, up to 8 digits.
Use the hyphen to insert dashes.
Note If you forget the password, you can use the master password:
0066838.
4. To require that the user enter an operator ID, select Security >
Operator ID.
5. Select On or Off (default).

Printing the Setup Report

When you have finished configuring the system, print the setup report,
showing all the setup options:
1. Select Ready > Settings > System Setup > Print Setup Report.
2. Keep the setup report in a place where you can refer to it as needed.

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Service Setup
1. Select Ready > Settings > Service Setup.
2. Select System Information, Language Selection, or Software
Update.

Entering System Information

Use the system information parameters to keep a record of the system
serial number, software revision, and service contact telephone number.
The system automatically records the software revision.
1. Select Ready > Settings > Service Setup > System Information.
2. Enter the service telephone number (up to 12 digits).
By default, the service telephone number is blank.
3. Enter the system serial number (4 digits).

Changing Language
1. Select Ready > Settings > Service Setup > Language Selection.
2. Select the appropriate language.
English is the default language selection.
Note Changing the language clears the data held in the calibration
summary. If you want to keep a record of all calibrations, print the
calibration summary, page 52, before changing the language.

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Appendix A: Concepts and Reference

Information

This appendix contains conceptual and reference information

underpinning the procedural information earlier in this book.

RAPIDLab 348EX System Overview

Figure 64: RAPIDLab348EX System Front View

1. Probe lever (closed)

2. Measurement block window (front cover closed)
3. Touch screen
4. Printer cover
5. Barcode reader
6. Gas cylinders
7. Waste bottle
8. Wash reagent

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9. 6.8/7.3 Buffer
10. Drip tray

Figure 65: RAPIDLab 348EX System, Cover Raised

1. Measurement block door

2. Sensors
3. Probe
4. Probe lever (open)
5. Touch screen
6. Front cover (raised)
7. Reagent pump
8. Sample pump

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The Back Panel

Figure 66: The Back Panel

1. RS-232 Ports (9-way, D-line)

2. Ethernet port (reserved for Siemens use)
3. USB ports
4. Power module (on-off switch, power connector and fuses)

The system has no internal user-replaceable parts. Do not remove the back
cover from the system.

Back Panel Symbols

Appendix G, Symbols describes the symbols that appear on the back of the
system.

Using the Touch Screen

You interact with the system through an integrated touch screen display.
The touch screen displays messages, options, and requests for information.
You respond by selecting a button or an area on the touch screen.

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The information displayed on the touch screen leads you through the
necessary steps to analyze samples, or to use any of the other functions.
To extend the life of the screen, the system dims the display brightness
after 10 minutes of inactivity and whenever the system is in Standby
mode. You can adjust the display brightness to suit your needs.

CAUTION
Do not use anything hard or pointed on the touch screen. Doing so might
damage the screen.

Menu Map
The touch screen displays a series of menus and display screens that let
you navigate through the system functions, select and perform specific
actions, and display results. The following table summarizes the principal
menus.

Parent Screen Leads to

Ready • Syringe, Capillary, QC, and Dialysis Fluid
analyses
• Settings/Main Menu
• Action List
Main Menu • Calibration
• Maintenance
• Troubleshooting
• Data Recall
• Operating, System, and Service Setup
• Standby
Action List • Sensors
• Deproteinize
• Condition
• Hct Slope
• Gas
• Printer
• QC
• Waste Bottle

Each of these menus leads to a series of submenus relevant to your

selections.

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Main Menu Options

To navigate to the Main Menu, select the Settings icon on the Ready
screen. The Main Menu provides access to submenus that let you calibrate
the system, set up operational parameters such as units, printer options,
reference ranges, correlations, and QC levels and prompts, recall data,
perform troubleshooting, and set up system parameters.

Action List
To display the Action List screen, select from the Ready screen. The
system prompts you to carry out various tasks associated with the Action
List. On the Main Menu, you can configure how often some of these
prompts appear; for example, Deproteinize, Condition, QC and Waste
Bottle. Other prompts appear when the system detects that user action is
required: Sensors, Hct Slope, Gas and Printer.
Action Required prompts appear over the Ready screen. For example, If the
system deselects a sensor because it has not passed a calibration, the
display shows which sensor is unavailable. The Action List displays the user
action required for Sensors.
Note The system suspends the system’s functions while it is displaying the
Action List, so you can replace the gas cartridges and empty the waste
bottle without stopping the system.

Calibration Overview
The system automatically calibrates using one of the following user-
selectable methods.
• Calibration drift
• Slope drift
• Calibration endpoint
• Slope endpoint
• Calibration range
• Slope range

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Five minutes before a calibration is due, the Ready screen shows a

countdown message indicating the time until the next calibration. You can
still measure samples during this time.

For Information About Go Here

Calibration Setup Section 5, Calibrating Your System

Troubleshooting Section 8, Troubleshooting

Selecting Calibration Method “Selecting Calibration Method and

and Timing Entering Gas Values” on page 49

Sensor Deselection
If a sensor fails calibration, the system deselects it, and it is not available
for sample or QC measurement. The deselection is flagged on the Ready
screen and, when first deselected, on the calibration printout.
The system monitors deselected sensors, and automatically reselects them
if they subsequently meet the calibration specifications.
Note The system does not calibrate while in standby mode, but it
automatically calibrates as required when restarted, before allowing
sample measurements.

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Calibration Setup Options and Values

Default Calibration Setup Options and Values
method time flexible
interval 30 minutes
gas values cal 5% CO2 12% O2
slope 10% CO2 0% O2

Calibration Gases
Two gas standards are used to calibrate the pCO2 and pO2 sensors.

Gas 1 (cal) Provides the calibration point for 1- and 2-point pCO2
and pO2 calibrations. The Cal Gas cartridge contains
5.00 ± 0.05% carbon dioxide and 12.00 ± 0.05%
oxygen, balanced with nitrogen, and is NBS traceable.
Gas 2 (slope) Provides the slope point for 2-point pCO2 and pO2
calibrations. The Slope Gas cartridge contains
10.00 ± 0.05% carbon dioxide balanced with nitrogen,
and is NBS traceable.

For information about safely handling gas cartridges, see Changing the
Gas Cartridges, page 72.

Selecting Calibration Method and Entering Gas Values

The calibration options let you:
• Choose the timing method the system uses when it calibrates.
• Select the maximum time interval between calibrations.
Siemens recommends that you set the calibration interval to 30
minutes.
• Enter non-Siemens gas values.
To set the calibration options, perform the actions listed in Selecting
Calibration Method and Entering Gas Values, page 49.

Recalling and Printing Calibration Data

The system maintains a calibration summary for all calibrations within a
24-hour period. The data includes the following values:
• System ID, time and date

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• Calibration summary interval

• Number of calibrations (including manually initiated calibrations)
• Calibration status. Any failed calibrations are detailed.
• Time, date, calibration number, and calibration report for any failed
calibration
You can print a calibration summary in the following ways:
• Automatically, by configuring the printer setup options to print the
summary every day at the end of the first calibration after 6 am. See
Setting Printer Options, page 151 and Manually Printing a Calibration
Summary, page 52.
• Manually, by performing the actions described in Manually Printing a
Calibration Summary, page 52.

Requesting Additional Calibrations

The system automatically calibrates using one of the user-selectable
methods. See Calibration Setup Options and Values, page 165.
The Calibration menu lets you perform additional, user-requested
calibrations. See Selecting Calibration Method and Entering Gas Values,
page 49.
Each type of calibration has its own screen displaying type of calibration in
the header line and the calibration values for the currently running
calibration type. The text updates dynamically to inform you which part of
the calibration cycle is being carried out.

Quality Control
See Chapter 6, Quality Control, for a full description of quality control
procedures. You can use the Data Recall menu to perform the following
functions:
• Printing statistical data for Levels 1 - 3 and Hct Levels A and B
• Recalling data for each QC sample
• Reassigning QC data to another level
• Printing results for each QC sample

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Setting Reference Ranges (All Measured Parameters)

You can set reference ranges for all measured parameters.
If a sample measurement is outside these ranges, the result is flagged on
the display and on the printout.
Individual reference values can vary according to a number of factors such
as age, posture, diet, exercise and site of blood collection. We have taken
these factors into account when establishing the default values for the
system.
See the following section for more detail about values used for reference
ranges.

Reference Ranges
Reference Ranges, also known as Reference Intervals, are guidelines only
and should not be considered as the sole indicator of health and disease.
Reference ranges can be affected by a number of factors, such as age,
gender, diet, exercise, site of blood collection, and a patient’s normal
physiological condition. Each facility should define the reference ranges
that are applicable to their patient populations. Reference Intervals for the
assays are shown in the table below.
The values provided on the following pages are derived from the technical
literature. For a list of citations from the technical literature, see Appendix
E, References.46-53

RAPIDLab 348EX Operator’s Guide page 167

Concepts and Reference Information

Reference Ranges Table

Units/Alternate Units of
Analyte Reference Interval
Measurement
pH pH 7.350–7.450a
H+ nmol/L 44.7–35.5
pCO2 mmHg 32.0–48.0b
kPa 4.27–6.40
c
pO2 mmHg 83.0–108.0d
kPa 11.07–14.40
+
Na mmol/L 136.0–145.0
K+ mmol/L 3.40–4.50
Ca++ mmol/L 1.15–1.33
mg/dL 4.6–5.3
-
Cl mmol/L 98–107
Calculated Units/Alternate Units of
Reference Interval
Parameter Measurement
Hct % 36–52e
decimal 0.36–0.52
HCO3-(act) mmol/L 21.0–28.0f
HCO3-(std) mmol/L 21.0–28.0f
BE (ecf) mmol/L -2.0 - +3.0
BE (B) mmol/L -2.0 - + 3.0
sO2 % 94.0–98.0g
decimal 0.940v0.980
AnGap mmol/L 10.0–18.0
Using equation
(Na + K)–(Cl +
HCO3-)
ctCO2 mmol/L 22.0–29.0
a. Includes children and adults < 60 years; arterial at 37°C.
b. Gender specifics exist: Female 32.0–45.0 mmHg, Male 35.0–48.0 mmHg.
c. Important: pO2 results from an arterialized capillary may be unreliable.
d. Includes from 2 days to 60 years.
e. Gender specifics exist: Adult female 36–47%, Adult male 40–52%.
f. Plasma
g. This is the range for adults. The range for newborns is: 40–90%.

page 168 RAPIDLab 348EX Operator’s Guide

Concepts and Reference Information

Configuring the System

Use the setup options on the Main Menu to configure the way you want
your system to work. Chapter 10, System Installation and Configuration
describes the configuration process in detail.

Setting Security
To protect the measurement sequence, you can configure the system to
require the user to enter an operator ID, and you can select password
protection for the Main Menu.

Requiring an Operator ID
The operator ID requirement protects sample and QC analysis. If the
operator ID-required option is selected, every sample and QC analysis
prompts you to enter your ID number. The operator ID number is printed
on sample and QC reports. Analysis does not continue until an operator ID
number has been entered.

Requiring a Menu Password

The menu password protects the Main Menu and guards against
unauthorized or accidental changing of setup options. The system allows
sample and QC measurement, and calibrates as required. If the menu
security option is enabled, the system prompts you to enter the password.
Menu access is prevented until the password has been entered correctly.
You can return to the Ready screen without entering the password.

RAPIDLab 348EX Operator’s Guide page 169

Concepts and Reference Information

page 170 RAPIDLab 348EX Operator’s Guide

Appendix B: Warranty and Support
Information

Standard Instrument Warranty and Service Delivery Policy

Siemens and its authorized distributors provide customers who acquire
new Siemens instruments with a one-year comprehensive, but limited,
warranty. 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.

Warranty Period
The warranty period commences upon installation at the customer's
location and extends for a period of one year thereafter. The customer,
with some exceptions, may purchase additional service coverage beyond
the one year 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.

Warranty Service During Normal Business Hours

The customer may obtain warranty service for instruments during normal
business hours by contacting the Siemens location or authorized
distributor. Refer to the list of Siemens locations in this section.

Extent of a Warranty Service Call

During the warranty period, Siemens (or an authorized distributor) will
repair the instrument during normal business hours, at their expense,
subject to the exclusions listed below. Siemens or an authorized distributor
will initiate a warranty field service call when notified. The call will be
considered complete when the instrument is again operating to its
published specifications and the customer, or the customer's
representative, has agreed by signing the appropriate Field Service Report.
When service is complete, the customer will receive a copy of the Field
Service Report detailing all work performed by the Siemens representative.

RAPIDLab 348EX Operator’s Guide page 171

Warranty and Support Information

Warranty Service Outside Normal Hours

Customers, with some exceptions, may also request warranty service to be
delivered outside of normal business hours, including evenings, weekend
days, or nationally observed holidays by contacting the Siemens location or
authorized distributor. Warranty service performed at these times is subject
to a surcharge unless the customer has purchased a service product option
that provides warranty service outside normal hours.

Replacement of Parts
In performing warranty service under this agreement, Siemens or its
authorized distributors will provide appropriate parts to repair the
instrument 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), Siemens reagents and calibrators, controls, pump tubing kits,
paper and pens. Consult the appropriate operator's manual for a complete
list of maintenance items for any specific model of instrument.

Design Changes and Retrofitting of Instruments

During the warranty period, Siemens reserves the right to change the
design or construction of specific models of instruments without incurring
any obligation to make such changes available to an individual instrument.
If Siemens notifies customers of a change that improves the performance
or reliability of their instrument, and requests to retrofit that instrument,
customers must agree to allow Siemens or an authorized distributor, at
Siemens expense, to retrofit components or make design changes, which
will not adversely affect the instrument's performance characteristics.

Key Operator Designation

Customers will designate a key operator who will be 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 warranty 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.

page 172 RAPIDLab 348EX Operator’s Guide

Warranty and Support Information

Warranty Exclusions
Siemens or its authorized distributors will provide warranty service to
customers during the warranty period, which includes appropriate parts,
travel to the location of the instrument, and on-site labour during normal
business hours. In addition, Siemens or its authorized distributors will
provide warranty service during the warranty period only, and instrument
repairs, labour or replacement parts, as provided during the original
warranty period, will not extend the original warranty period.

Warranty Exclusions
This warranty does not apply if any of the following occurs:
1. Repairs or modifications have been made to the instrument by other
than an authorized Siemens representative.
2. The instrument has been operated using other than Siemens brand
accessories, or consumable supplies and/or reagents not having the
same grade, quality, and composition as defined by Siemens.
3. The instrument has not been installed within 90 days of shipment to
the customer's facility unless otherwise specified.
4. The customer has not performed appropriate customer maintenance
procedures, as outlined in the instrument operator's manual.
5. The instrument has been misused or used for a purpose for which it
was not intended.
6. 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.
7. Damage was caused by floods, earthquakes, tornadoes, hurricanes or
other natural or man-made disasters.
8. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil
commotion.
9. Damage was caused by electrical surges or voltages exceeding the
tolerances outlined in the instrument operator's manual.
10. Damage was caused by water from any source external to the
instrument.
11. The customer has purchased an alternative agreement whose terms of
warranty supersede this agreement.

RAPIDLab 348EX Operator’s Guide page 173

Warranty and Support Information

Siemens or its authorized distributors will invoice customers, at current

standard labour and parts rates, for instruments repaired to correct
damage or malfunctions due to any of the reasons listed above.

Limitations of Siemens Original Warranty

Siemens warrants to all customers that service will be performed in a
professional manner consistent with the industry. If the instrument is not
performing according to its specifications, Siemens will, at its option, repair
or replace the instrument. This is the customer's sole and exclusive remedy
for breach of warranty.
Other than as stated above, there are no other warranties, express or
implied, accompanying either the leasing of the equipment or its sale to
the customer at the expiration or termination of this agreement. In
addition, the warranties of merchantability and fitness for a particular
purpose are disclaimed. In addition, Siemens shall not be liable for any
damages caused by delay in providing repair service from any cause.
Siemens liability for breach of this warranty shall be limited to the repair or
replacement of defective equipment and shall not include any incidental,
contingent, or consequential damages.

IT Security
See the product’s Security White Paper and MDS2 for additional
information about specifications for software, hardware, network
characteristics, and security controls. This technical information is not part
of the operator guide, and is intended for the information technology or
security professional. Security White Paper and MDS2 can be found at
siemens-healthineers.com/poc or contact your local technical service
provider.

Disposal of the Analyzer

The instrument must be treated as biological contaminated hazardous
waste. Proper disposal of old instruments (including its plastic parts,
electrical components) prevents potential negative consequences for the
environment and human health. All electrical and electronic products and
other components of the analyzer should be disposed of separately from
the municipal waste system. Final disposal must be organized in a way that
does not endanger waste handlers. As a rule, such equipment must be
sterile before it is passed for final disposal. For more information about
disposal of such product, please contact your city office, waste disposal
service, or your local safety officer.

page 174 RAPIDLab 348EX Operator’s Guide

Warranty and Support Information

Technical Assistance
For technical assistance, customer service, or additional information,
contact your local technical provider or distributor.
siemens-healthineers.com/poc
The summary of safety and performance for this in vitro diagnostic medical
device is available to the public in the European database on medical
devices (EUDAMED) when this database is available and the information
has been uploaded by the Notified Body. The web address of the EUDAMED
public website is: https://ec.europa.eu/tools/eudamed.
According to EU regulation 2017/746, any serious incident that has
occurred in relation to the device shall be reported to the manufacturer
and the competent authority of the EU Member State in which the user
and/or patient is established.

Training
This guide describes the proper use and operation of the system. System
operators and administrators should familiarize themselves with the
applicable sections in the manual prior to conducting testing to assure safe
and effective use of the system. As training requirements for this device
vary by country and region, make sure you follow any training in
accordance with local, federal, or country laws and regulations. If you
require further information about training in the use of this product,
contact your local Siemens Healthineers representative.

RAPIDLab 348EX Operator’s Guide page 175

Warranty and Support Information

page 176 RAPIDLab 348EX Operator’s Guide

Appendix C: Orderable Supplies

• Ordering Information, page 177

• Orderable Spares, page 178
• Reagents, page 183

Ordering Information
When ordering supplies, please give the following information to your local
distributor:
• System serial number (To locate the serial number, see Entering
System Information, page 158.)
• Article number of part
• Description
• Quantity required
This ensures that your order is dealt with quickly and efficiently. The
number shown in the Quantity column is the number of items supplied
against that catalog number. If the quantity is more than 1, only multiples
of that number can be supplied. For a comprehensive list of service spares,
see the Service Manual.

RAPIDLab 348EX Operator’s Guide page 177

Orderable Supplies

Orderable Spares
Description Quantity SMN/REF Catalog Article/Part
Number Number Number
Reference 1 10329947 478509000 09388182
electrode inner,
with KCl fill
solution
Reference sensor 1 kit 10320458 478498 04273425
refill, contains
reference sensor
cassette, KCl fill
solution and
O-rings
Probe and tubing 1 kit 10309797 107275 01880878
kit
Probe and 1 kit 10311628 673253 06152072
housing kit
Probe 1 pack 10324749 673373 06565849
protectors, pack
of 10
Bottle tubing kit 1 kit 10309778 105672 06865362
Sample pump 1 10309780 105674 00782481
tubing kit
Reagent pump 1 10309781 105675 04376879
tubing kit
Sample and 1 10309779 105673 04814094
reagent pump
tubing kit
Clot removal 1 pack 10311063 478645 07110136
line, 0.5 m
(19 1/2 inches)
Drip tray 1 10311630 673255 03521867
pH sensor plus 1 10312556 476267 07173251
O-ring
pCO2 sensor plus 1 10317498 476247 02671199
O-ring
pO2 sensor plus 1 10324408 476246 06462640
O-ring

page 178 RAPIDLab 348EX Operator’s Guide

Orderable Supplies

Description Quantity SMN/REF Catalog Article/Part

Number Number Number
Na+ sensor plus 1 10312557 476266 09463893
O-ring
K+ sensor plus 1 10327404 476270 08001888
O-ring
Ca++ sensor plus 1 10315922 476268 01810225
O-ring
Cl– Sensor plus 1 10330133 476279 00183065
O-ring
Hct sensor 1 10309783 106042 06553743
Reference 1 kit 10323084 476273 05719400
sensor, contains
reference sensor
cassette,
reference
electrode inner,
KCl fill solution
and O-rings
Gas cartridge 1 pack 10309768 105070 00384192
pack, containing
gas 1 (cal) and
gas 2 (slope), 1
cartridge of each
Gas cartridge 1 10314899 107678 01255779
venting tool
Gas cartridge 1 10329532 107679 09171841
removal tool
Ca++/Cl– sensor 1 10311665 673702 00768594
blank (TB3)
Test blank 1 10327492 673396 08053446
sensor - ref (TB5)
Pre-heater tube 1 10309777 105671 01109527
kit
Fluid detector 1 1 10311637 673266 00659477
(serial numbers
below D001
only)

RAPIDLab 348EX Operator’s Guide page 179

Orderable Supplies

Description Quantity SMN/REF Catalog Article/Part

Number Number Number
Fluid detector 2 1 10311663 673359 06864900
(serial numbers
below D001
only)
Fluid detector 1 1 11046693 NA NA
(serial numbers
above D001
only)
Fluid detector 2 1 11046694 NA NA
(serial numbers
above D001
only)
Power supply 1 10336289 00142498X 05357096
cord, without
connector
Power supply 1 10319275 00142617F 03628246
cord, with USA
style connector
Power supply 1 10323672 00171415A 06048720
cord, with
European
connector
Power supply 1 10323838 001 71 06139440
cord, with UK 416X
connector
Printer paper 5 rolls 10314709 673252 01150195
Service manual 1 NA NA NA
Operator's 1 10698291 10698291 10698291
Guide, English
Operator's 1 10698295 10698295 10698295
Guide, Japanese
RAPIDLab 348EX 1 10698303 10698303 10698303
System Interface
Manual, English
RAPIDLab 348EX 1 10698306 10698306 10698306
System Interface
Manual,
Japanese

page 180 RAPIDLab 348EX Operator’s Guide

Orderable Supplies

Description Quantity SMN/REF Catalog Article/Part

Number Number Number
RAPIDLab 348EX 1 10698309 10698309 10698309
Quick Reference
Guide
RAPIDLab 348EX 1 10698311 10698311 10698311
Documentation
CD
MULTICAP® 1 pack 10314796 473193 01198961
capillary tubes,
50 x 140 μL
MULTICAP 1 pack 10311005 473646 06493996
capillary tubes,
500 x 140 μL
Caps for 140 μL 1 pack 10311054 478605 01158100
capillary tubes,
pack of 100
MULTICAP blood 1 kit 10314213 473823 00855578
collection kit,
containing 100 x
60 μL capillary
tubes and 200
caps
MULTICAP 1 pack 10323539 673394 05974729
capillary tubes,
50 x 100 μL
MULTICAP 1 pack 10322912 108758 05614986
capillary tubes,
500 x 100 μL
pH/blood gas 1 pack 10310090 471836 08851318
blood collection
capillary tubes,
100 x 100 μL
capillaries
Plastic capillary 1 pack 10313252 00335434 00335434
tube,
50 x 100 μL
Plastic capillary 1 pack 10322986 05656514 05656514
tube,
500 x100 μL

RAPIDLab 348EX Operator’s Guide page 181

Orderable Supplies

Description Quantity SMN/REF Catalog Article/Part

Number Number Number
Plastic capillary 1 pack 10320937 04549544 04549544
tube,
50 x 140 μL
Plastic capillary 1 pack 10313226 00325811 00325811
tube,
500 x 140 μL
Plastic capillary 1 pack 10324363 06440221 06440221
tube,
50 x 175 μL
Plastic capillary 1 pack 10316361 02043295 02043295
tube,
500 x 175 μL
Caps for 100 μL 1 pack 10311053 478601 01687040
capillary tubes,
pack of 200
Adaptors for 1 pack 10330785 478647 09851273
capillaries, pack
of 100
Interface cable, 1 10325225 116113 6818607
RAPIDLab 348EX
system to
RAPIDComm®
data
management
system

page 182 RAPIDLab 348EX Operator’s Guide

Orderable Supplies

Reagents
Description Quantity SMN Catalog Article
Number Number
6.8/7.3 Buffer Pack, 1 pack 10309757 104227 01410308
contains: 4 Buffer
Packs
Wash Pack, contains: 4 1 pack 10309756 104226 02490356
Wash bottles and 4
User Action Packs (not
Japan)
Wash Pack, contains: 4 1 pack 10329872 106370 09349799
Wash bottles (Japan
only)
Hct slope, 10 x 2 mL 1 pack 10309776 105670 06990590
ampules
Deproteinizer, pack of 1 pack 10309775 105610 08915030
10
Conditioner, pack of 5 1 pack 10301078 478701 02578644
pH sensor fill solution, 1 pack 10301046 478533 06386650
pack of 3, plus O-ring
Na+/K+/Ca++/Cl– sensor 1 pack 10311047 478535 08999595
fill solution, pack of 3,
plus O-ring
Reference sensor fill 1 pack 10311081 478822 02563698
solution,pack of 4,
plus O-ring
RAPIDQC® Plus, Level 1 pack 10323692 478941 06057533
1, 30 x 2.5 mL
ampules
RAPIDQC Plus, Level 2, 1 pack 10341140 478942 03867186
30 x 2.5 mL ampules
RAPIDQC Plus, Level 3, 1 pack 10325104 478943 06750158
30 x 2.5 mL ampules
Calibration 1 pack 10316535 116189 02147872
Verification Material
(CVM), 4 x 2.5 mL
ampules each level
RAPIDQC Hct QC Level 1 pack 10311392 570405 04116087
A, 30 x 2.5 mL
ampules

RAPIDLab 348EX Operator’s Guide page 183

Orderable Supplies

Description Quantity SMN Catalog Article

Number Number
RAPIDQC Hct QC Level 1 pack 10311393 570406 06081574
B, 30 x 2.5 mL
ampules
Hct Calibration 1 pack 10330034 570407 09445216
Verification Material
(CVM), 4 x 2.5 mL
ampules each level

page 184 RAPIDLab 348EX Operator’s Guide

Appendix D: Interfacing to External Devices

• LIS 1, page 185

• LIS 2, page 186
• LIS 3, page 186
The system has two data ports – Port 1 and Port 2 (Figure 67 ).

Figure 67: Left: Port 1 (Female), Right: Port 2 (Male)

Data Port 1 (Female) Data Port 2 (Male)

Pin 1 Not used Pin 1 Not used
Pin 2 Tx data (transmitted) Pin 2 Tx data (transmitted)
Pin 3 Rx data (received) Pin 3 Rx data (received)
Pin 4 DTR (data terminal ready) Pin 4 DTR (data terminal ready)
Pin 5 0V digital Pin 5 0V digital
Pin 6 Not used Pin 6 Not used
Pin 7 Not used Pin 7 Not used
Pin 8 CTS (clear to send) Pin 8 CTS (clear to send)
Pin 9 Not used Pin 9 +5V digital

For details on interfacing to external devices, refer to the RAPIDLab 348EX

Interface Manual.
The system supports 3 data communication protocols on Port 1. Port 2
supports only the LIS 1 protocol. For information about configuring the
data ports, see Changing Communication Options, page 156.

LIS 1
LIS 1 allows communication to external printers or to data collection
systems that accept asynchronous, unidirectional data transmission.

RAPIDLab 348EX Operator’s Guide page 185

Interfacing to External Devices

LIS 1 Data Format (default)

Baud rate 9600
Start bit 1
Stop bit 1
Data bits 8
Parity OFF

The transmitted data has the same format as the data sent to the internal
printer.

LIS 2
LIS 2 allows communication to external data collection systems which
accept asynchronous, unidirectional data in LIS 2 format.
LIS 2 Data Format (default)
Baud rate 9600
Start bit 1
Stop bit 1
Data bits 8
Parity OFF

The transmitted data has the format and protocol defined in the
RAPIDLab 348EX Interface Manual.

LIS 3
LIS 3 allows communication to HIS and LIS systems.
LIS 3 Data Format (default)
Baud rate 9600
Start bit 1
Stop bit 1
Data bits 8
Parity OFF

The transmitted data has the format and protocol defined in the
RAPIDLab 348EX Interface Manual.

page 186 RAPIDLab 348EX Operator’s Guide

Appendix E: References

This section lists the documents referred to in the rest of this guide.
1. Clinical and Laboratory Standards Institute. Blood Gas and pH Analysis
and Related Measurements; Approved Guideline-Second Edition
(includes CLSI/NCCLS C27-A). CLSI Document C46-A2. Wayne (PA):
CLSI; 2009.
2. Douglas IHS, McKenzie PJ, Leadingham I, Smith G. Effect of halothane
h. on pO2 electrode. Lancet 1978: (Dec. 23 and 30).
3. Clinical and Laboratory Standards Institute. GP05-A3 (Electronic
Document) Clinical Laboratory Waste Management. Wayne (PA): CLSI;
2011.
4. U.S. Dept. of Health and Human Services. Health Care Financing
Administration Public Health Service. 42 CFR Part 405, Subpart K, et al,
Federal Register: Clinical Improvement Amendments of 1988; Final
Rule. Washington, D.C.: GPO, 1992.
5. Clinical and Laboratory Standards Institute. Principles and Definitions;
Approved Guideline - Second Edition. CLSI Document C24-A2. Villanova
(PA): CLSI; 1999.
6. Tietz NW ed. Fundamentals of Clinical Chemistry. 3rd ed. Philadelphia:
WB Saunders, 1987; 864-891.
7. Eastham RD. Biochemical Values in Clinical Medicine. John Wright Ltd,
1985.
8. Richterich R, Colombo JP. Clinical Chemistry: Theory, Practice and
Interpretation. John Wiley and Sons, 1981.
9. Borow M, Fundamentals of Homeostasis. 2nd ed. Medical Examination
Publishing Co 1977.
10. Bold AM, Wilding P. Clinical Chemistry: SI units with Adult Normal
Reference Values. Blackwell Scientific Publications, 1975.
11. Lentner C ed. Geigy Scientific Tables, Vol. 3: Physical Chemistry
Composition of Blood, Hematology Somatometric Data. Vol 3, 8th ed.
Basle: Ciba- Geigy Ltd., 1984; 82-83.
12. Mayne PD et al. J Clin Pathol 1984; 37: 859-861.
13. Urban P et al. Clin Chem 1985; 31/2: 264-266.

RAPIDLab 348EX Operator’s Guide page 187

References

14. Clinical and Laboratory Standards Institute. Protection of laboratory

workers from occupationally acquired infections. 3rd ed. CLSI
Document M29-A3. Wayne (PA): CLSI; 2005.
15. Clinical and Laboratory Standards Institute. Protection of laboratory
workers from occupationally acquired infections. 3rd ed. CLSI
Document M29-A3. Wayne (PA): CLSI; 2005.
16. Siggaard-Anderson O. Electrochemistry. In: Tietz NW editor.
Fundamentals of Clinical Chemistry. 3rd ed Philadelphia: WB Saunders,
1987. 87-100.
17. 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.
18. Severinghaus JW, Bradley AF. Electrodes for blood pO2 and pCO2
determination. J Appl Physiol 1968; 13:515-520.
19. Clark LC Jr. Monitor and control of blood and tissue oxygen tensions.
Trans Am Soc Artif Intern Organs 1956; 2: 41-56.
20. Shapiro BA, Harrison RA, Cane RD, Templin R. Clinical application of
blood gases. 4th ed. Chicago: Year Book Medical Publishers, 1989.
270-272.
21. Fricke H. Phys Rev 1924; 24:575-587.
22. Barth E et al. Eur J Clin Chem Clin Biochem 1991; 29(4):281-292.
23. Moran R, Cormier A. The blood gases: pH, pO2, pCO2. Clin Chem News
1988; 14(4/5): 10-12.
24. Pagana KD, Pagana TJ. Diagnostic testing and nursing implications: A
Case Study Approach. 3rd ed. St. Louis: CV Mosby, 1990. 448-449.
25. 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.
26. 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.
27. Clinical Laboratory Standards Institute. Definitions of quantities and
conventions related to blood pH and gas analysis. CLSI Document
C12-A. Villanova (PA): CLSI; 1994.

page 188 RAPIDLab 348EX Operator’s Guide

References

28. VanSlyke DD, Cullen 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.
29. Clinical Laboratory Standards Institute. Fractional oxyhemoglobin,
oxygen content and saturation, and related quantities in blood:
terminology, measurement, and reporting; tentative standard. CLSI
Document C25-T. Villanova (PA): CLSI; 1992.
30. Martin L. Abbreviating the alveolar gas equation: an argument for
simplicity. Respir Care 1985; 30(11):964-967.
31. 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.
32. Burrit MF, Cormier AD, Maas AHJ, 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.
33. Lecky JH, Ominsky AJ. Postoperative respiratory management. Chest
1972; 62:50S-57S.
34. Horovitz JH et al. Pulmonary response to major injury. Arch Surg 1974;
108:349-355.
35. Cane R et al. The unreliability of oxygen tension based indices in
reflecting intrapulmonary shunting in the critically ill. Crit Care Med
1988; 12:1243-1245.
36. Ciba Corning CBA focus discussions with intensive care specialists.
37. Moran RF, Bradley F. Blood gas systems - major determinants of
performance. Laboratory Medicine 1981; 12 (6) 353-358.
38. Beetham R. A review of blood pH and blood gas analysis. Ann Clin
Biochem 1982; 19: 198-213.
39. Vedda GL, Holbeck CC. Properties of commercially available control
materials for pH, pCO2 and pO2. Clin Chem 1980; 26: 1366-7.
40. Weisberg HF. Acid-Base pathophysiology in the neonate and infant.
Annals of Clinical and Laboratory Science 1982; 12(4)249.
41. Kirchoff 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.

RAPIDLab 348EX Operator’s Guide page 189

References

42. Thomas LJ. Algorithms for selected blood acid-base and blood gas
calculations. J Appl Physiol 1972; 33:154-158.
43. Stott RAW et al. Clin Chem 1995; 41(2):306-311.
44. Bakerman S in ABCs of Interpretive Laboratory Data. 1984 2nd Ed; 225.
45. Davis RE. Laboratory Practice. 1983; 15(12): 1376-1378.
46. Burtis C. and Bruns D. Tietz Fundamentals of Clinical Chemistry and
Molecular Diagnostics. Seventh Edition. St. Louis, MO: Elsevier
Saunders; 2015.
47. Tietz NW. Clinical Guide To Laboratory Tests. Philadelphia,
PA: Saunders; 1983.
48. Tietz NW. Fundamentals of Clinical Chemistry. Third Edition.
Philadelphia, PA: Saunders; 1987.
49. Bakerman, S. Bakerman’s ABCs: ABC’s of Interpretive Laboratory Data.
Fourth Edition. Interpretive Laboratory Data, Inc.; 2002.
50. Malley W. Clinical blood gases: Application and Non-Invasive
Alternatives. Philadelphia, PA; Saunders; 1990.
51. Wu, A. Tietz Clinical Guide To Laboratory Tests. Fourth Edition.
Philadelphia, PA: Saunders; 2006.
52. Meites, S. Editor-in-Chief. Pediatrics Clinical Chemistry: Reference
(Normal) Values. Third Edition.AACC Press; Washington DC; 1989.
53. Tietz NW. Textbook of Clinical Chemistry. Third Edition. Philadelphia,
PA: Saunders; 1986.

page 190 RAPIDLab 348EX Operator’s Guide

Appendix F: Specifications

This appendix contains system specifications, including measurement

ranges, method comparisons, precision and recovery information,
precision on controls, measurement time, heater temperature ranges,
samples information, display and printer specifications, warm-up time,
environmental conditions, power requirements, size and weight, and a
reference to the reagents used.

Measurement Range
The measurement range specifies the range for the indicated measured
parameters.
Note See Measurement Range - Dialysis Fluid Mode, page 206 for
specifications for dialysis fluid mode.

Measured Parameters
Parameter Range
pH 6.001–8.000 (10.0–997.7 nmol/L H+)
pCO2 5.0–250.0 mmHg (0.67–33.33 kPa)
pO2 0.0–749.0 mmHg (0.00–99.86 kPa)
Na+ 80–200 mmol/L
K+ 0.50–9.99 mmol/L
Ca++ 0.20–5.00 mmol/L
–
Cl 40–160 mmol/L
Hct 12–75%
pAtm 400–825 mmHg (53.3–110.0 kPa)

RAPIDLab 348EX Operator’s Guide page 191

Specifications

Calculated Parameters
Parameter Range
HCO3(act and std) 0.0–60.0 mmol/L
BE (ecf and B) ±29.9 mmol/L
ctCO2 0.0–60.0 mmol/L
O2SAT 0.0–100.0%
O2CT 0.0–40.0 mL/dL
pO2(A-a) 0.0–749.0 mmHg (00–99.86 kPa)
pO2(a/A) 0.00–1.00
AnGap ±60.0 mmol/L
ctHb(est) 2.0–25.0 g/dL (20–250 g/L,
1.2–15.5 mmol/L)
Ca++(7.4) 0.20–5.00 mmol/L
pO2/FIO2 0.00–5.00

Limit of Quantitation
Altered low level whole blood samples were run across three lots,
minimum of 3 replicates, on three RAPIDLab 348EXs. Each Analyzer was
dedicated to a specific lot of reagent. Samples that overlapped the low end
of the measuring interval were used for analysis of Limit of Quantitation
for every analyte.

Parameter Limit of Quantitation

pO2 0.6 mmHg
pCO2 6.7 mmHg
pH 6.061 units
Na+ 84 mmol/L
K+ 0.83 mmol/L
Cl- 49 mmol/L
++
Ca 0.23 mmol/L
Hct 15%

RAPIDLab 348EX Parameter Linearity

All parameters on RAPIDLab 348EX systems are linear within the tested
range as determined by following EP06-A:2003.

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Specifications

RAPIDLab 348EX Interfering Substances

The following table illustrates whether substances listed interfere with the
specified analyte measurements at the concentrations indicated in the
substance column.

Substance Analyte Effect

Acetaminophen (at 20 mg/dL) pH No
Acetaminophen (at 20 mg/dL) Ca++ No
Salicylic Acid (at 50 mg/dL) Ca++, Cl- No
-
Acetylsalicylic acid (at 50 mg/dL) Cl No
Ibuprofen (at 40 mg/dL) pH, Ca++ No
Sodium Pentothal Ca++, Cl-, pH and K+ No

Irenat Interference
Irenat (Sodium Percholorate) can falsely lower ionized calcium results.
We recommend the following preventive actions:
• 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.

Method Comparison
A comparison of whole blood samples run on 6 RAPIDLab 348 systems was
performed. The comparison was run against the RAPIDLab 248 analyzer for
pH, tonometered blood for pCO2 and pO2, the 480 flame photometer for
Na+ and K+, the 634 ISE analyzer for Ca++, the 925 chloride meter for Cl–
and the Hawksley Microcentrifuge for Hct.
The comparison was repeated for micro sample mode.
In the following tables, the linear regression analysis equation is
y = mx + b, and C of C is the coefficient of correlation. The letter M
precedes instrument model numbers.
Note All performance data presented in this section was generated using
RAPIDLab 348 systems. In respect to performance characteristics, the
RAPIDLab 348EX system is statistically equivalent to the RAPIDLab 348
system. The data below represents the performance of both the
RAPIDLab 348 system and the RAPIDLab 348EX system.

RAPIDLab 348EX Operator’s Guide page 193

Specifications

pH
n 180
Range 7.000–7.680 (H+ 15.8–100.0 nmol/L)
Equation M348 = M248 x 0.999 + 0.007
C of C 1.000

pCO₂
n 180
Range 14.2–149.3 mmHg (1.89–19.91 kPa)
Equation M348 = tonometry x 0.999 - 0.356
C of C 0.999

pO₂
n 180
Range 28.3–372.6 mmHg (3.77–49.68 kPa)
Equation M348 = tonometry x 0.986 +1.731
C of C 0.999

Na⁺
n 180
Range 85–172 mmol/L
Equation M348 = M480 x 0.996 - 1.070
C of C 0.998

K⁺
n 180
Range 2.42–7.05 mmol/L
Equation M348 = M480 x 1.013 - 0.086
C of C 0.999

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Specifications

Ca⁺⁺
n 90
Range 0.69–3.10 mmol/L
Equation M348 = M634 x 0.982 - 0.001
C of C 0.999

Cl⁻
n 90
Range 57–130 mmol/L
Equation M348 = M925 x 1.045 - 4.602
C of C 0.998

Hct
n 136
Range 12–60%
Equation M348 = microcentrifuge x 1.008 - 0.331
C of C 0.994

RAPIDLab 348EX Operator’s Guide page 195

Specifications

Micro Sample Mode

pH
n 270
Range 6.986–7.707 (H+ 19.6–103.3 nmol/L)
Equation M348 = M248 x 1.021 - 0.129
C of C 0.998

pCO₂
n 270
Range 14.1–150.4 mmHg (1.88–20.05 kPa)
Equation M348 = tonometry x 1.014 - 2.564
C of C 0.998

pO₂
n 270
Range 28.3–493.5 mmHg (3.77–65.79 kPa)
Equation M348 = tonometry x 1.022 - 8.451
C of C 0.998

Na⁺
n 360
Range 122–172 mmol/L
Equation M348 = M480 x 1.044 - 7.485
C of C 0.991

K⁺
n 360
Range 2.31–7.64 mmol/L
Equation M348 = M480 x 0.997 - 0.026
C of C 0.995

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Specifications

Ca⁺⁺
n 180
Range 0.24–4.04 mmol/L
Equation M348 = M634 x 0.978 - 0.017
C of C 0.993

Cl⁻
n 180
Range 83–131 mmol/L
Equation M348 = M925 x 1.037 - 3.749
C of C 0.978

Hct
n 156
Range 12–60%
Equation M348 = microcentrifuge x 1.036 - 1.672
C of C 0.999

RAPIDLab 348EX Operator’s Guide page 197

Specifications

Method Comparison - RL348EX Blood Gas

A total of n=475 whole blood samples were presented to all n=4 M348 and
n=4 348EX.
This testing showed, for all analytes, no instances where the mean 348EX
analyzer results exhibited non-equivalency, in terms of Deming regression,
to the existing mean M348 Blood Gas Analyzer results with slope values
obtained all being within the specification of 0.90 < m < 1.10 and R²
criteria of > 0.95.
Analyte n Range Units Equation R2
pH 475 6.720–7.607 348EX = 348 x 0.997 + 0.018 0.999
pCO2 475 6.225–230.3 mmHg 348EX = 348 x 0.964 - 0.058 0.999
pO2 475 28.0–688.6 mmHg 348EX = 348 x 1.012 + 1.138 0.999
+
Na 475 89–183 mmol/L 348EX = 348 x 1.001 - 0.524 0.997
+
K 475 1.78–8.61 mmol/L 348EX = 348 x 1.012 - 0.066 0.998
Ca++ 475 0.52–4.69 mmol/L 348EX = 348 x 0.995 - 0.014 0.998
Cl– 475 60–144 mmol/L 348EX = 348 x 1.038 - 3.737 0.986
Hct 475 12–75 % 348EX = 348 x 1.019 - 0.829 0.997

Method Comparison - RL348EX Dialysis Fluid

Analyte n Range Units Equation R2
Na+ 38 100 –185 mmol/L 348EX = 348 x 0.981 + 2.144 0.999
K+ 38 0.7–8.0 mmol/L 348EX = 348 x 1.001 - 0.004 1.000
Ca++ 38 0.25–4.1 mmol/L 348EX = 348 x 1.009 - 0.048 0.999

page 198 RAPIDLab 348EX Operator’s Guide

Specifications

Precision and Recovery on Whole Blood

Whole blood was tonometered at 37°C for pH, pCO2 and pO2 analysis for 6
levels, and spiked/diluted for Na+, K+, Ca++, Cl– and Hct analysis for 6 levels,
and run on 4 RAPIDLab 348EX systems. In the tables that follow, WRSD
means within-run standard deviation.

Level 1
Analyte n WRSD Expected Observed %Recovery %CV
pH 10 0.004 7.026 7.023 100.0 0.06
H+ nmol/L 10 0.966 94.2 94.9 100.7 1.02
pCO2 mmHg 10 0.146 20.5 20.9 102.0 0.70
pCO2 kPa 10 0.020 2.73 2.78 102.0 0.70
pO2 mmHg 10 0.258 48.6 49.3 101.5 0.52
pO2 kPa 10 0.034 6.48 6.58 101.5 0.52
Na+ mmol/L 10 0.734 109 108 99.0 0.68
K+ mmol/L 10 0.023 3.22 3.19 98.9 0.72
++
Ca mmol/L 10 0.006 1.08 1.04 96.0 0.58
–
Cl mmol/L 10 0.550 68 67 98.9 0.82
Hct % 10 0.392 28 30 105.2 1.32

Level 2
Analyte n WRSD Expected Observed %Recovery %CV
pH 10 0.003 7.112 7.111 100.0 0.04
H+ nmol/L 10 0.489 77.2 77.5 100.3 0.63
pCO2 mmHg 10 1.938 33.6 34.3 102.1 5.66
pCO2 kPa 10 0.258 4.48 4.57 102.1 5.66
pO2 mmHg 10 0.447 84.7 85.3 100.7 0.52
pO2 kPa 10 0.060 11.30 11.38 100.7 0.52
+
Na mmol/L 10 0.584 126 124 99.1 0.47
K+ mmol/L 10 0.026 3.64 3.62 99.3 0.71
Ca++ mmol/L 10 0.013 1.27 1.23 97.0 1.08
Cl– mmol/L 10 0.753 90 90 99.9 0.84
Hct % 10 0.329 32 33 103.3 0.99

RAPIDLab 348EX Operator’s Guide page 199

Specifications

Level 3
Analyte n WRSD Expected Observed %Recovery %CV
pH 10 0.010 7.234 7.231 100.0 0.13
H+ nmol/L 10 1.295 58.4 58.7 100.5 2.21
pCO2 mmHg 10 0.485 46.0 47.0 102.1 1.03
pCO2 kPa 10 0.065 6.14 6.26 102.1 1.03
pO2 mmHg 10 0.688 106.7 107.3 100.6 0.64
pO2 kPa 10 0.092 14.23 14.31 100.6 0.64
+
Na mmol/L 10 0.240 134 133 99.9 0.18
K+ mmol/L 10 0.030 4.18 4.14 99.1 0.72
Ca++ mmol/L 10 0.007 1.29 1.28 98.7 0.56
–
Cl mmol/L 10 1.156 96 97 100.9 1.19
Hct % 10 0.460 39 39 100.9 1.18

Level 4
Analyte n WRSD Expected Observed %Recovery %CV
pH 10 0.013 7.372 7.370 100.0 0.17
H+ nmol/L 10 1.255 42.5 42.7 100.6 2.94
pCO2 mmHg 10 0.769 68.3 69.8 102.3 1.10
pCO2 kPa 10 0.102 9.10 9.31 102.3 1.10
pO2 mmHg 10 1.349 152.7 153.7 100.6 0.88
pO2 kPa 10 0.180 20.36 20.49 100.6 0.88
Na+ mmol/L 10 0.316 140 141 100.3 0.22
K+ mmol/L 10 0.036 5.94 5.95 100.1 0.61
++
Ca mmol/L 10 0.014 1.44 1.44 100.1 0.97
Cl– mmol/L 10 0.943 100 101 100.9 0.94
Hct % 10 0.627 52 53 100.7 1.19

page 200 RAPIDLab 348EX Operator’s Guide

Specifications

Level 5
Analyte n WRSD Expected Observed %Recovery %CV
pH 10 0.004 7.446 7.447 100.0 0.06
H+ nmol/L 10 0.353 35.8 35.7 99.7 0.99
pCO2 mmHg 10 0.763 99.9 100.7 100.8 0.76
pCO2 kPa 10 0.102 13.32 13.43 100.8 0.76
pO2 mmHg 10 1.762 198.6 199.7 100.6 0.88
pO2 kPa 10 0.235 26.48 26.63 100.6 0.88
+
Na mmol/L 10 0.409 150 149 99.4 0.28
K+ mmol/L 10 0.053 6.98 7.03 100.8 0.75
Ca++ mmol/L 10 0.012 1.71 1.69 98.9 0.68
–
Cl mmol/L 10 0.516 110 110 100.0 0.47
Hct % 10 0.418 61 62 100.6 0.68

Level 6
Analyte n WRSD Expected Observed %Recovery %CV
pH 10 0.009 7.568 7.565 100.0 0.12
H+ nmol/L 10 0.573 27.0 27.2 100.7 2.11
pCO2 mmHg 10 1.314 135.1 136.4 101.0 0.96
pCO2 kPa 10 0.175 18.01 18.18 101.0 0.96
pO2 mmHg 10 5.237 385.0 389.3 101.1 1.35
pO2 kPa 10 0.698 51.34 51.90 101.1 1.35
Na+ mmol/L 10 0.654 169 168 99.4 0.39
K+ mmol/L 10 0.042 7.61 7.62 100.1 0.55
++
Ca mmol/L 10 0.027 2.20 2.17 98.3 1.23
Cl– mmol/L 10 1.719 135 137 101.4 1.26
Hct % 10 0.303 73 73 101.0 0.41

Precision on Controls
Data was collected across 4 RAPIDLab 348EX systems over 20 days. In the
following tables, Total SD means total standard deviation.

RAPIDLab 348EX Operator’s Guide page 201

Specifications

pH
Level n Mean Total SD %CV
1 160 7.125 0.003 0.05
2 160 7.386 0.003 0.04
3 160 7.581 0.003 0.04

H⁺ (nmol/L)
Level n Mean Total SD %CV
1 160 74.9 0.6 0.78
2 160 41.1 0.3 0.75
3 160 26.3 0.2 0.67

pCO₂ (mmHg)
Level n Mean Total SD %CV
1 160 73.9 0.7 0.97
2 160 44.5 0.4 0.84
3 160 23.6 1.4 6.00

pCO₂ (kPa)
Level n Mean Total SD %CV
1 160 9.9 0.1 0.97
2 160 5.9 0.0 0.84
3 160 3.2 0.2 6.00

pO₂ (mmHg)
Level n Mean Total SD %CV
1 160 55.3 0.7 1.36
2 160 93.3 0.7 0.71
3 160 144.0 1.5 1.01

pO₂ (kPa)
Level n Mean Total SD %CV
1 160 7.4 0.1 1.36
2 160 12.4 0.1 0.71
3 160 19.2 0.2 1.01

page 202 RAPIDLab 348EX Operator’s Guide

Specifications

Na⁺ (mmol/L)
Level n Mean Total SD %CV
1 160 119.2 1.1 0.92
2 160 140.9 0.7 0.48
3 160 159.7 0.7 0.42

K⁺ (mmol/L)
Level n Mean Total SD %CV
1 160 3.05 0.01 0.30
2 160 4.97 0.02 0.47
3 160 7.06 0.05 0.72

Ca⁺⁺ (mmol/L)
Level n Mean Total SD %CV
1 80 1.66 0.03 1.74
2 80 1.25 0.01 0.89
3 80 0.76 0.02 2.06

Cl⁻ (mmol/L)
Level n Mean Total SD %CV
1 80 86.4 1.0 1.19
2 80 109.3 1.3 1.19
3 80 127.7 1.6 1.22

Hct (%)
For Hct, data was collected from 5 runs across 4 RAPIDLab348EX systems
over 20 days.
Level n Mean Total SD %CV
1 64 14.0 1.0 6.9
2 160 26.5 0.6 2.4
3 160 48.6 0.7 1.4
4 64 65.0 0.8 1.2

Note Hct levels 1 and 4 analyzed in syringe mode as CVM.

RAPIDLab 348EX Operator’s Guide page 203

Specifications

Measurement Time
Results are displayed within 45 to 90 seconds of returning the probe
(typically less than 60 seconds).

Heater
The sensor operating temperature is 37.0°C ± 0.15°C.
The pre-heater temperature is 37°C ± 1°C.

Samples
For information about collecting, storing, and handling of samples, see
Section 3, Handling Samples and Reagents. In addition, observe the
following precautions:
• Use whole blood, properly collected.
• Ensure that the sample is free from hemolysis
• Store any samples that are not analyzed immediately according to the
procedures in Section 3, Handling Samples and Reagents.
• You can analyze fresh samples at a temperature of up to 40°C.
• We recommend using Siemens QC material and Siemens Calibration
verification material.

Sample Volume
95 μL (syringe/capillary) nominal, 50 μL (micro capillary sample).

Display and Printer

Display
VGA 640 x 480 color touch screen display.

Printer
32-character thermal printer.

page 204 RAPIDLab 348EX Operator’s Guide

Specifications

Environmental Conditions
Operation
Temperature range 15–32°C
Ambient operating relative 5–85%, non-condensing
humidity
Maximum relative humidity 85% at 32°C, non-condensing
Barometric pressure range 400–825 mmHg
Maximum ambient light 8000 lux

Transportation
Temperature range 4°C–37°C
Maximum relative humidity 95% at 37°C

Storage
Temperature range 4°C–25°C
Maximum relative humidity 95% at 25°C

Power Requirements
Power rating 80VA
Voltage 100–240 VAC, 50/60 Hz
Leakage current < 0.5 mA

Size
With Barcode Reader
Width 50.0 cm (19.6 inches)
Depth 35.3 cm (13.9 inches)
Height 38.2 cm (15.0 inches)
Weight 9.8 kg (21.6 lb) system only
12.2 kg (26.9 lb) system + reagents and gas

RAPIDLab 348EX Operator’s Guide page 205

Specifications

Without Barcode Reader

Width 38.5 cm (15.2 inches)
Depth 35.3 cm (13.9 inches)
Height 38.2 cm (15.0 inches)
Weight 9.4 kg (20.7 lb) system only
11.8 kg (26.0 lb) system + reagents and gas

Reagents
See Appendix C, Orderable Supplies for a complete list of reagents for use
with the system. Store solutions at 4–25°C, away from direct sunlight.

Measurement Range - Dialysis Fluid Mode

Measured Parameters - Dialysis Fluid Mode
In dialysis fluid mode, the system directly measures the following
parameters on acetate or bicarbonate-based renal fluid dialysates; that is,
after dilution from the associated dialysis fluid concentrate.
Note All performance data on dialysis fluid for sodium and potassium
presented in this section was generated using RAPIDLab 348 systems. In
respect to the performance characteristics, the RAPIDLab 348EX system is
statistically equivalent to the RAPIDLab 348 system, therefore the
performance data is representative of the RAPIDLab 348EX system. The
performance data generated for ionized calcium on dialysis fluid was
performed on the RAPIDLab 348EX system only.
Parameter Units Measurement Range Resolution
pH pH 6.001–8.000 0.001
H+ nmol/L 10.0–997.7 0.1
pCO2 mmHg 5.0–250.0 0.1
kPa 0.67–33.33 0.01
+
Na mmol/L 80–200 1
K+ mmol/L 0.50–9.99 0.01
Ca++ mmol/L 0.20–5.00 0.01

page 206 RAPIDLab 348EX Operator’s Guide

Specifications

Calculated Parameters - Dialysis Fluid Mode

The following parameters are calculated, not directly measured.
Parameter Units Measurement Range Resolution
Actual bicarbonate mmol/L 0.0–60.0 0.1
ctCO2 mmol/L 0.0–60.0 0.1

Accuracy on Measured Parameters - Dialysis Fluid Mode

Na+ Mean difference from reference method ±2 mmol/L
(flame photometry)
K+ Mean difference from reference method ±0.1 mmol/L
(flame photometry)
pH This value is provided only for indication
pCO2 This value is provided only for indication
++
Ca This value is provided only for indication

Within-run Precision - Dialysis Fluid Mode

Na+ CV is 1% typical (1.5% at 95% confidence interval)
K+ CV is 1% typical (1.5% at 95% confidence interval)

Sample Size - Dialysis Fluid Mode

Dialysis fluid sample size is nominally 240 μL.

RAPIDLab 348EX Operator’s Guide page 207

Specifications

page 208 RAPIDLab 348EX Operator’s Guide

Appendix G: Symbols

This appendix lists the symbols displayed on the system and system
packaging and the meaning of each symbol.

System and Packaging

Symbol Description
Shows the probe lever position for sampling from
syringes and capillaries.

Shows the probe lever position for sampling from

ampules and other open top containers.

Cautions you not to spray this area with cleaning

solutions or other fluids that may damage
sensitive parts of the system.

Shows the direction of rotation of the pump.

Cautions you about the risk of exposure to

potential electrical hazards.

Alerts you to important information about the

fuses.

Indicates that the input electricity is alternating

current.

Alerts you to important information about gas

bottle pressure.

Indicates the instrument ground test point (earth

terminal).

RAPIDLab 348EX Operator’s Guide page 209

Symbols

Symbol Description
• In this manual, this symbol is used for both
Warnings and Cautions.
A WARNING indicates the risk of personal
injury or loss of life if operating procedures
and practices are not correctly followed.
A CAUTION indicates the possibility of loss of
data or damage to or destruction of
equipment if operating procedures and
practices are not strictly observed.
• On the touch screen, this symbol indicates
that action is required.

Indicates that this equipment is classified as Waste

Electrical and Electronic Equipment under the
European WEEE Directive. It must be recycled or
disposed of in accordance with applicable local
requirements.

Indicates that the analyzer is classed as IEC Type B

equipment (Class 1 equipment providing an
adequate degree of protection against electric
shocks particularly regarding allowable leakage
currents and reliability of the protective earth
connection).

Indicates that the instrument has been tested for

safety by TÜV SÜD, a national certification body,
for conformity to global markets, including
Canada, US, and Europe.

CE Mark.

Indicates an in vitro diagnostic medical device.

Manufacturer.

Date of manufacture.

page 210 RAPIDLab 348EX Operator’s Guide

Symbols

Symbol Description
Authorized Representative.

Catalog Number.

Cautions you about the risk of exposure to

biohazards.

Identifies the location of the USB ports.

Advises you to consult the operating instructions

to obtain information needed for the proper use of
the instrument.

Shows the area in which the date can be written in

pencil.

Fragile, handle with care.

Temperature limitation (4°–25°C).

Keep dry.

Keep away from sunlight and heat.

Sterile.

Batch code.

Serial number.

Use by date.

RAPIDLab 348EX Operator’s Guide page 211

Symbols

Symbol Description
Control.

Indicates maximum fill level.

Do not re-use.

Cautions you that this is a heavy object that

requires assistance to lift.

Do not stack.

Do not use if package is damaged.

Keep this way up.

Please recycle this packaging.

Printed on recycled materials.

Device for near patient testing.

Indicates compliance with Green Dot packaging

standards.

Indicates compliance with RESY packaging

standards.

This system contains certain toxic or hazardous

substances or elements. The environmental
protection use period for this system is 50 years.
The system can be used safely during its
environmental protection use period. The system
should be recycled immediately after its
environmental protection use period has expired.

page 212 RAPIDLab 348EX Operator’s Guide

Symbols

Symbol Description
This symbol identifies a hazardous area on the
equipment.

This symbol identifies the location of a power

connector (power cord).

This symbol identifies the location of a serial port.

This symbol identifies the location of the USB port.

This symbol identifies the Laboratory Information

System.

This symbol identifies that this electronic

information product does not contain any toxic or
hazardous substances or elements, and is green
and environmental. This system can be recycled
after being discarded, and should not be casually
discarded.
This symbol identifies the system power button

User Interface
This section describes the symbols that display on the system user
interface.

Symbol Action Description

Back Select this button to exit the current screen
without saving and change the display back to
the previous screen in the series.
Next Select this button to display the next screen in
the series.

Up Select this button to display the previous

result or entry.

RAPIDLab 348EX Operator’s Guide page 213

Symbols

Symbol Action Description

Down Select this button to display the next result or
entry.
System This symbol indicates that the system is busy
Busy or that a timer is counting down.

Select Select this button to perform a syringe sample

syringe test.
sample
Select Select this button to perform a capillary
capillary sample test.
sample
Quality Select this button to perform a Quality Control
Control (QC) test.
Select DF Select this button to perform a Dialysis Fluid
sample (DF) sample test.
Settings Select this button to configure system
settings.
Beep On Toggles the audible beep signal on.

Beep Off Toggles the audible beep signal off.

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Appendix H: Operating Principles

The system measurement technology is based on electrochemistry.

Electrochemistry is the measurement of current, or voltage, occurring in an
electrochemical cell, between a chemical and an electrical system.
Each electrode, or sensor, is designed to selectively measure the
concentration of a specific substance. Many elements in a sample may
interact with a sensor, but the sensor is highly selective for one substance
over others. The hematocrit sensor measures the conductance of the
sample, and the Hct % is calculated from this value.
The potential generated at the sensor is converted into an electronic signal
by a transducer mechanism. The system uses potentiometry, amperometry
and conductivity. Potentiometry measures the potential that develops at
the sensor. Amperometry and conductivity involve applying a voltage to
the sensor and then measuring the current generated.
The electronic signal is filtered and smoothed, and converted into a
concentration measurement expressed in standard units.

Potentiometry
During sample analysis, a potential develops at the sensor as a result of the
interaction with the analyte (ion). The potential is related to the amount of
analyte in the sample.
The reference sensor provides a fixed potential, which is independent of
analyte activity, and is used to compare the measured potential.
The sensor potential corresponds to the analyte activity, and is directly
related of the concentration of the analyte in solution. The potential is
expressed by the Nernst equation:
Ecell = K + (2.3RT/ZF) log ai
where:

Ecell = electrochemical cell potential

K = a constant (produced by various sources such as
the liquid junction)
R = gas constant
T = absolute temperature
Z = ionic charge

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F = Faraday’s constant
ai = activity of the ion in the sample

This equation shows that the potential is logarithmically related to the

activity of the analyte in the sample.
However, the sensor actually measures the activity of the analyte in
solution. In clinical chemistry results are typically expressed as
concentration rather than activity. The activity of an ion is equivalent to the
concentration (mol/L) multiplied by the activity coefficient (the degree
with which the ion interacts with other ions in solution). The activity
coefficient depends on the ionic strength of the solution, and generally
decreases with increasing ionic strength.16
Using an established convention, the activity of ions as measured by the
sensors can be expressed as concentration. Ionic strength is the primary
variable affecting the activity coefficient of ions in solution. The normal
ionic strength of blood plasma water is 160 mmol/kg.17
Controlling the ionic strength of calibrating solutions to 160 mmol/kg sets
the activity coefficients of ionic species in the calibrations equal to those of
blood plasma water at ionic strengths close to normal. Both calibrations
and measurements may then be expressed in units of concentration rather
than activity.

Amperometry
Amperometry is an electrochemical technique used to determine the
amount of analyte in solution by applying a fixed voltage between two
electrodes in an electrochemical cell, then measuring the current flowing.
The measuring electrode is negatively charged and serves as a cathode in
the electrical system. The reference electrode is positively charged, and
serves as the anode. Both electrodes are attached to an external voltage
source.
As the sample comes into contact with the two electrodes, a known
voltage is applied to the cathode. This voltage attracts molecules from the
analyte in solution to the cathode causing a chemical reaction (reduction)
that uses electrons. The electrons are replaced immediately in the sample
solution by a separate reaction (oxidation) that takes place at the anode.
The two reactions result in a current flow that can be measured. The
current measured is directly proportional to the concentration of analyte
(reacting at the cathode) present in the sample.

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Conductivity
Conductivity is a non specific measurement of a solution's ability to pass
current. A fixed alternating voltage is applied via a known resistance to the
outer terminals of a 4 pole sensor. The voltage difference between the two
inner terminals and the outer terminals is measured.
Conductance is the reciprocal of resistance, and Ohm’s Law states that:
resistance = applied voltage / current flowing
therefore:
conductance = current flowing / applied voltage
The conductivity (C) in a cell is given by the equation:
C = A / GL
where:
A = the cross-sectional area of the cell
L = the distance between the terminals of the cell, and
G = the conductance measured

Sensors
Reference Sensor
The reference sensor contains a silver (Ag) wire, coated with a layer of
silver chloride (AgCl) surrounded by a saturated potassium chloride (KCl)
solution. By making sure that the concentration of chloride ions (Cl–)
remains unchanged in the solution, the reference sensor maintains a
constant electrical potential. KCl is added to the reference sensor solution
chamber to maintain a saturated solution of KCl at 37°C.
A permeable cellulose membrane separates the KCl solution from the
sample. During analysis a diffusion potential, created between the sample
and KCl solution, provides the fixed half-cell potential required for
measurement.
The Ag wire conducts the potential 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.

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Figure 68: Reference Sensor (cutaway view)

1. Fill Cap
2. Fill Solution
3. Sensor Contact
4. Inner electrode (Ag/AgCl wire)
5. O-rings
6. Sample path

pH Sensor
The pH sensor is based on ISE technology and is a half-cell that forms a
complete cell with the external reference sensor. It contains a silver/silver
chloride wire (Ag/AgCl) surrounded by a buffer solution of fixed hydrogen
ion concentration. A glass membrane, highly sensitive and specific for
hydrogen ions, separates the sample from the solution.
As the sample comes into contact with the membrane of the pH sensor, a
potential develops due to the exchange of hydrogen ions in the
membrane. The silver/silver chloride wire conducts 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 calculate the pH value.

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Figure 69: pH Sensor (cutaway view)

1. Sensor Contact
2. Inner electrode (Ag/AgCl wire)
3. Fill solution
4. Sample path
5. O-rings

Na⁺ Sensor
The Na+ sensor is based on ISE technology and is a half-cell that forms a
complete cell with the external reference sensor. It contains a silver/silver
chloride wire (Ag/AgCl) surrounded by an electrolyte solution of fixed
sodium and chloride ion concentration. A glass membrane, highly sensitive
and specific for sodium ions, separates the sample from the solution.
As the sample comes into contact with the membrane of the Na+ sensor, a
potential develops due to the exchange of sodium ions in the membrane.
The silver/silver chloride wire conducts the potential to a voltmeter where
it is compared to the constant potential of the reference sensor. The final
measured potential is proportional to the sodium ion concentration of the
sample.
The Na+ sensor components are very similar to the pH sensor, shown in
Figure 69.

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K⁺ Sensor
The K+ sensor is based on ISE technology and is a half-cell that forms a
complete cell with the external reference sensor. It contains a silver/silver
chloride wire (Ag/AgCl) surrounded by an electrolyte solution of fixed
potassium ion concentration. The membrane consists of valinomycin (an
ionophore) in a plasticized PVC (polyvinylchloride) matrix and separates
the sample from the solution. Valinomycin is a neutral ion carrier that is
highly sensitive and specific for potassium ions.
As the sample comes into contact with the membrane of the potassium
sensor, a potential develops due to the interaction of potassium ions with
the membrane. The silver/silver chloride wire conducts the potential to a
voltmeter where it is compared to the constant potential of the reference
sensor. The final measured potential is proportional to the potassium ion
concentration of the sample.
The K+ sensor components are very similar to the pH sensor, shown in
Figure 69.

Ca⁺⁺ Sensor
The Ca++ sensor is based on ISE technology and is a half-cell that forms a
complete cell with the external reference sensor. It contains a silver/silver
chloride wire (Ag/AgCl) surrounded by an electrolyte solution of fixed
calcium ion concentration. An ionophore in a plasticized PVC (polyvinyl-
chloride) matrix forms the membrane and separates the sample from the
solution. The ionophore is a compound that is highly sensitive and specific
for calcium ions.
As the sample comes into contact with the membrane of the Ca++ sensor, a
potential develops due to the interaction of calcium ions with the
membrane. The silver/silver chloride wire conducts the potential to a
voltmeter where it is compared to the constant potential of the reference
sensor. The final measured potential is proportional to the calcium ion
concentration of the sample.
The Ca++ sensor components are very similar to the pH sensor, shown in
Figure 69.

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Cl⁻ Sensor
The Cl– sensor is based on ISE technology and is a half-cell that forms a
complete cell with the external reference sensor. It contains a silver/silver
chloride wire (Ag/AgCl) surrounded by an electrolyte solution of fixed
chloride ion concentration. The membrane consists of a derivitized
quaternary ammonium compound immobilized in a polymer matrix, and
separates the sample from the solution. The membrane acts as an ion
exchanger which is highly sensitive and specific for chloride ions.
As the sample comes into contact with the membrane of the chloride
sensor, a potential develops due to the exchange of chloride ions at the
membrane. The silver/silver chloride wire conducts the potential to a
voltmeter where it is compared to the constant potential of the reference
sensor. The final measured potential is proportional to the chloride ion
concentration of the sample.
The Cl– sensor components are very similar to the pH sensor, shown in
Figure 69.

pCO ₂ Sensor
The pCO2 sensor is based on the electrode described by Severinghaus and
Bradley18 and 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 contains a silver/silver chloride electrode surrounded by the
chloride-bicarbonate solution, and provides a fixed potential.
As the sample comes into contact with the membrane, CO2 diffuses into
the chloride-bicarbonate solution causing a change in the hydrogen ion
concentration.
The internal pH electrode generates a potential that is compared to the
fixed potential of the internal reference electrode. This results in a
measurement that reflects pH change in the chloride-bicarbonate solution.
The change in pH is proportional to the log of the partial pressure of pCO2.

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Figure 70: pCO2 Sensor (cutaway view)

1. Sensor Contacts
2. Sample path
3. O-rings

pO₂ Sensor
The pO2 sensor is based on the electrode described by Clark19 and uses
amperometric technology. The sensor consists of a platinum (Pt) cathode,
a silver (Ag) anode, an electrolyte solution and a gas permeable
membrane.
A constant voltage, called a polarizing voltage, is maintained between the
anode and the cathode. As dissolved oxygen from the sample passes
through the membrane into the electrolyte solution, it is reduced at the
cathode. The circuit is completed at the anode, where the Ag is oxidized.
The amount of oxygen reduced 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 sample can be determined.20

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Figure 71: pO2 Sensor (cutaway view)

1. Sensor Contacts
2. Sample path
3. O-rings

Hct Sensor
The Hct sensor consists of two 4-pole cells connected in parallel. The drive
terminal is common to both cells. The Hct sensor also acts as the
grounding block for the measurement path.
Conductivity based measurements depend upon the observation that, for
relatively low frequency currents, red blood cells act as perfect insulators.
The conductivity of these red blood cells is a function of the conductivity of
the suspending medium, the volume of suspending cells, and the shape of
the cells. A mathematical equation describing the conductivity of a
suspension of homogenous spheroids was developed by Fricke.21
Conductivity based hematocrit measurements are now used in a number
of multi-analyte blood gas systems.22
As the system also measures the concentration of Na+ and K+ ions, which
contribute towards the conductivity of the sample, the % Hct can be
accurately determined.

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Operating Principles

Figure 72: Hct sensor (cutaway view)

1. Sensor Contacts
2. Sample path
3. O-rings

Measuring pH, Blood Gases, Electrolytes, and Hct

pH
pH expresses the hydrogen ion activity in a solution as the negative
logarithm of the hydrogen ion concentration:
pH = –logcH+
where cH+ is the molar concentration of hydrogen ions.
The hydrogen ion is 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
donate hydrogen ions; bases remove hydrogen ions. The lungs, kidneys
and blood all work to maintain the acid-base status within the strict limits
necessary.
The Henderson-Hasselbalch equation describes how pH expresses the
interaction of acid and base in blood:
pH = pK + log base / acid

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where K is the dissociation constant, which describes the ability of a

solution to release hydrogen ions. Since K, and therefore pK, is a constant,
this equation can be used to demonstrate that pH is proportional to the
acid-base concentrations in blood.
pH is clinically significant as a means to determine acid-base disturbances.
Acid-base disorders can result in several pathological conditions. An acid-
base disorder resulting initially from ventilatory dysfunction is called a
primary respiratory acidosis or alkalosis, while one due to renal or
gastrointestinal inadequacy is referred to as metabolic acidosis or alkalosis.
Using acceptable therapeutic ranges, a pH less than 7.3 indicates acidosis,
and a pH greater than 7.5 indicates alkalosis.23

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).
The levels of HCO3–, H2CO3, and dissolved CO2 play a major role in
maintaining the pH in blood. pH is proportional to the acid-base
relationship.
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 the
HCO3– in addition to the ctCO2. Since the pCO2 value is proportional to the
content of dissolved CO2/HCO3–, the value for pCO2 can be used with pH
not only to calculate HCO3–, but also to aid in the differentiation of acid-
base abnormalities.
The measurement of pCO2 is essential in determining ventilatory status.
Because the lungs are primarily responsible for controlling pCO2 levels,
changes in pCO2 reflect respiratory status. For example, an increase in CO2
indicates decreased ventilation as CO2 is retained, and a decrease in CO2
indicates increased ventilation (hyperventilation) as CO2 is expired from
the lungs.

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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 where CO2 is
retained by the lungs. A decrease in the pCO2 value, and an increase in pH
indicates respiratory alkalosis—a condition where the lungs are expiring
too much CO2 relative to the amount produced.

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 four major steps: convection and diffusion from
the air into the pulmonary circulation, combination of O2 from the lungs
with haemoglobin 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 cellular level.
Since it is not possible to measure intra-cellular oxygen tension, arterial
pO2 has become a standard for clinical evaluation of arterial oxygenation
status. pO2(A) measurement, which indicates the oxygen tension in
arterial blood, reflects the pressure or driving force for moving oxygen
from one location to the next due to pressure differential. Although not a
measurement of the O2 content, this provides a measurement tool to
evaluate the pulmonary gas exchange efficiency from an arterial blood
sample.
Complete laboratory evaluation of oxygenation 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.20
The measurement of pO2 is significant in evaluating the degree of
hypoxemia (a deficiency of O2 in arterial blood) present in a patient.

Hct
Hematocrit (Hct) is defined as the volume occupied by red blood cells in a
given volume of whole blood and is represented by:
Hct% = (volume occupied by red blood cells/volume of sample) x 100

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The major role of hematocrit determinations in critical care is to assess

blood loss, and to monitor the recovery after blood loss. Hct values are
often used as a criterion for transfusion therapy. Serial hematocrit
measurements are recommended when upper GI hemorrhage presents as
a clinical emergency, or for rupture of the spleen in children. Following
cardiopulmonary bypass surgery, the resultant significant hemodilution
causes a fall in hematocrit, and this correlates with hypotension frequently
encountered in such surgery.
Hematocrit is of great value in the management of burns patients and in
monitoring patients with hemoconcentration associated with trauma and
surgery. Hematocrit determinations help evaluate the blood volume status
of the infant in the Neonatal Intensive Care Unit. Typically, Hct and Hb in
conjunction with blood pressure and maternal history help evaluate
whether a transfusion should be given. Hct and Hb are monitored for a
sudden decrease which may indicate intracranial hemorrhage.

Na⁺
Sodium (Na+) is the most abundant cation in the extracellular space in the
body. It 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.
Clinically, plasma sodium levels are significant in diagnosing and treating
conditions related to sodium imbalance, such as gastroenteritis, vomiting,
diarrhea, Addison’s disease, and acute renal failure.

K⁺
Potassium (K+) is the major intracellular cation. It 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.

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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.
Because the serum level of potassium is so small, minor changes can have
significant consequences. Therefore, monitoring potassium levels is
important especially in patients who are undergoing surgery, or who are
experiencing cardiac arrhythmias or acute renal failure, and who are being
treated with diuretics. Additionally, regulating serum potassium is
significant in cardiac patients who are receiving digitalis therapy, since
hypokalemia can increase cardiac sensitivity to digoxin.24

Ca⁺⁺
Ionized calcium (Ca++) is the physiologically active form of calcium, which
comprises approximately 45% of the total calcium in plasma. It is essential
for the contractility of smooth vascular muscle, and, it plays a vital part in
cardiovascular function. It is also important in muscle function, nerve
function, 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.25
Clinically, hypocalcemia can result from a deficiency of PTH or 1,25 D,
which can be caused by malabsorption of vitamin D, hypoparathyroidism,
or chronic renal failure. Hypercalcemia, which occurs more frequently than
hypocalcemia, is commonly caused by primary hyperparathyroidism and
malignant disease. The elevated calcium resulting from both of these
conditions can produce abnormal cardiovascular rhythms.
In critical care situations, especially where large amounts of blood are
being transferred, ionized calcium levels should be monitored closely.
Transfused blood typically contains citrate as an anticoagulant that can
bind ionized calcium and affect its level in the blood. Although total
calcium levels may increase, ionized calcium may decrease and lead to
cardiac and neuromuscular malfunction.

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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.26

Cl⁻
Chloride (Cl–) is the major extracellular anion in the body. It 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.
Hypochloremia is usually seen in states of hyponatremia. However in
pyloric stenosis, chloride levels are usually proportionally lower than
sodium levels. Hyperchloremia is seen in cases of excessive administration
of chloride and in renal failure. Additionally, because the chloride level
remains fairly constant, it is valuable in the calculation of the anion gap.

Calculated Parameters
The system calculates other parameters of interest to clinicians and uses
several different equations to provide these parameters. Unless otherwise
noted, all measured values used in equations are at 37°C.

Bicarbonate Ion (HCO₃⁻)

Bicarbonate (HCO3–) is the major buffer substance present in the body,
and plays a major role in maintaining the pH level in blood. It is present in
large amounts in the blood as a result of the dynamic state of CO2 in the
blood. The majority of CO2 is transported as HCO3–.
The kidneys are the major controller of bicarbonate ion. Bicarbonate levels
are clinically significant in helping to determine the non-respiratory, renal
(metabolic) component in acid-base disorders.

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Changes in HCO3– levels, along with pH values, can help determine if

acidosis or alkalosis disorders are of metabolic origin. In metabolic acidosis,
HCO3– levels decrease, causing an increase in H+, which leads to a decrease
in pH. Conversely, in metabolic alkalosis, HCO3– levels increase, causing a
decrease in H+ which leads to an increase in pH.
There are 2 versions of bicarbonate, the actual value and the standard
value, available in the System Set Up menu.

Actual Bicarbonate (HCO₃⁻act)

Based on the Clinical Laboratory Standards Institute (CLSI)
recommendations27:
cHCO3–act = 0.0307 x pCO2 x 10(pH – 6.105)

Standard Bicarbonate (HCO₃⁻std)

The equation described by VanSlyke and Cullin28 is used for calculating
standard bicarbonate:
cHCO3–std = 24.5 + 0.9A + (A – 2.9)2 (2.65 + 0.31ctHb)/1000
where A = BE(B) – (0.2ctHb(100 – O2SAT)/100)

Base Excess
Base excess is an empirical expression that approximates the amount of
acid or base required to titrate one litre of blood back to a normal pH of
7.4. The base excess in blood with a pH of 7.4, pCO2 of 40 mmHg
(5.33 kPa), total haemoglobin of 15 g/dL and a temperature of 37°C is zero.
Base excess is useful in the management of patients with acid-base
disorders, as it allows the estimation of the number of equivalents of
sodium bicarbonate or ammonium chloride required to correct the
patient’s pH to normal.
There are 2 versions of base excess, available in the System Set Up menu.

Base Excess of Extracellular Fluid (BE(ecf))

The base excess of extracellular fluid, formerly known as in vivo base
excess, reflects only the non-respiratory component of pH disturbances:
BE(ecf) = cHCO3–act – 24.8 + 16.2 (pH – 7.4)

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Base Excess of Blood (BE(B))

The base excess of blood, formerly known as in vitro base excess, is
calculated from the following equation:
BE(B) = (1 – 0.014ctHb) (cHCO3–act – 24.8 + (1.43ctHb + 7.7) (pH – 7.4))
If no ctHb value has been entered, a value of 15 g/dL is assumed.

Oxygen Content (O₂CT)

Oxygen content is the concentration of the total oxygen carried by the
blood, including oxygen bound to haemoglobin as well as oxygen
dissolved in plasma and in the fluid within red cells.
Oxygen content is calculated, using CLSI recommendations29, as follows:
O2CT = (1.39ctHb x O2SAT/100) + (0.00314pO2)
where ctHb is expressed in g/dL.
If no ctHb value has been entered, or if ctHb(est) is not available, O2CT is
not calculated.
Clinically, dissolved oxygen is for most situations analytically unimportant.
However, at very low levels of haemoglobin or in patients receiving
hyperbaric oxygen therapy, dissolved oxygen may be a very significant
contributor to oxygen transport.

Oxygen Saturation (Estimated)

Oxygen saturation (O2SAT) is a ratio, expressed as a percentage of the
volume of oxygen carried to the maximum volume that can be carried.
Knowledge of oxygen saturation is useful for predicting the amount of
oxygen actually available for the tissues and can be used to determine the
effectiveness of oxygen therapy.
Note Clinically significant errors can result from incorporating an
estimated O2SAT value in further calculations, such as shunt fraction
(Qsp/Qt), or by assuming that the value obtained is equivalent to fractional
oxyhaemoglobin.29
O2SAT = N4 – 15N3 + 2045N2 + 2000N/N4 – 15N3 + 2400N2 – 31,100N +
(2.4 x 106) x 100
where N = pO2 x 10[0.48(pH–7.4) – 0.0013 BE(B)]

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Because oxygen saturation also depends on the level of carbon monoxide

and 2, 3 diphosphoglycerate (2, 3 DPG) in the blood, the calculated value
for oxygen saturation may not be equal to that actually measured for
patients showing abnormal levels of 2, 3 DPG or carbon monoxide. The
equation does not account for these variations, therefore the oxygen
saturation that is reported should be used only as an estimate of the actual
value.

Total Carbon Dioxide (ctCO₂)

Total carbon dioxide (ctCO2), in combination with pH and pCO2, is useful in
distinguishing between metabolic and respiratory acid-base disorders.
Carbon dioxide exists in several forms in blood plasma, but only 2 forms,
dissolved CO2 and HCO3– are quantitatively significant. Based on CLSI
recommendations27, the following equation is used:
ctCO2 = cHCO3–act + (0.0307 x pCO2)

Patient Temperature Correction

All measurements and calculations are based on a standard temperature of
37°C. Actual patient temperature values can be entered during sample
analysis, which allows the RAPIDLab 348EX system to provide temperature-
corrected results. The following equations, based on CLSI
recommendations27, are used:
pH(T) = pH – (0.0147 – 0.0065 x (7.4 – pH)) x (T – 37)
pCO2(T) = pCO2 x 10(0.019 x (T – 37))
pO2(T) = pO2 x 10(A x (T – 37))
where A = 5.49 x 10–11 x pO23.88 + 0.071 / 9.72 x 10–9 x pO23.88 + 2.3
and where T = 37°C if not entered.

ctHb(est)
ctHb is used in calculated parameters. The system uses ctHb values in the
following precedence: entered (obtained from a direct measuring
method), estimated from the system Hct value, or the default setting of
15 g/dL.
Note The system does not calculate O2CT if entered ctHb or ctHb(est) is
not available.
The system estimates ctHb using the following equation:
ctHb(est) = Hct (%) / 2.941

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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. 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. The gas exchange indices are
provided for convenience. Final judgment of their use is in the hands of the
physician. The gas exchange indices require an arterial sample and use
measured values at patient temperature.

Alveolar O₂
Alveolar O2, referred to as pO2(A) or pAO2, is the partial pressure of oxygen
in alveolar gas. It is a primary component in the detection of gas exchange
indices. The following equation20, 30 is used to estimate the alveolar O2:
pO2(A)(T) = FIO2/100 x (pAtm – pH2O) – pCO2(T) x (1.25 – 0.25 x FIO2 /
100)
pH2O = 10(0.0244 x T + 0.7655) + 0.4

Arterial-Alveolar Oxygen Tension Difference

The arterial-alveolar oxygen tension difference (pO2(A–a)), (or A–aDO2) is
useful as an index of gas exchange within the lungs if ctO2 measurements
are not available. The following equation20, 30 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)), (or a/A ratio) provides
an index of oxygenation that remains relatively stable when FIO2 changes.
It is useful in predicting oxygen tension in alveolar gas.
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.
Note If FIO2 value is not entered, the gas exchange indices are not
calculated.

RAPIDLab 348EX Operator’s Guide page 233

Operating Principles

Calcium Adjustment for pH

Ionized calcium values are dependent on sample pH. The calcium value
adjusted to pH 7.40 reflects the true ionized calcium concentration of
blood normalized to pH 7.40. The calcium value is adjusted according to
the following equation32;
adjusted Ca++ = Ca++ measured x 10 –0.178[7.40 pH – measured pH]
The calcium value is adjusted only when the measured pH is between 7.2
and 7.7 at 37°C, as no reliable, published clinical data is available outside
that range.

Anion Gap
The anion gap (AnGap) is an approximation of the difference between
unmeasured cations and unmeasured anions. Historically, several formulas
have been used to mathematically approximate the balance of these
unmeasured ions.
An anion gap result is of twofold value in a clinical laboratory. Primarily,
abnormal anion gap results indicate electrolyte imbalance or other
conditions where electroneutrality is disrupted, such as seen with diabetes,
toxin ingestion, lactic acidosis, or dehydration. Secondly, the anion gap
result is useful for quality assurance of laboratory results. If an increased or
decreased anion gap result is calculated from a non-diseased individual this
indicates the possibility of one or more erroneous electrolyte results.
The system calculates anion gap using the following equation:
AnGap = (Na+ + K+) – (Cl– + HCO3–act)

pO₂/FIO₂ Ratio
The arterial oxygen tension (pO2) to inspired oxygen concentration (FIO2)
ratio was introduced in the 1970s to avoid calculation of alveolar pO2.33, 34
The ratio has achieved some utility as an oxygenation index if shunt
parameters are not available. The accuracy with which the ratio reflects
shunt varies in the literature.35 In a heterogenous group of critically ill
patients Cane et al found the ratio, in terms of affecting shunt, to be
somewhat comparable to the Respiratory Index and the arterial to alveolar
ratio.35 However, a number of intensive care physicians favor the use of
the pO2/FIO2 ratio as an oxygenation index.
The system calculates the pO2/FIO2 ratio using the following equation:
pO2 / FIO2 = pO2 (mmHg) / FIO2(%)

page 234 RAPIDLab 348EX Operator’s Guide

Operating Principles

Note If FIO2 value is not entered, the gas exchange indices are not
calculated.
The algorithms used for Calculated Parameters are those currently
recommended by CLSI. Algorithms used in our earlier instruments are
given here for reference:

Actual Bicarbonate (HCO₃⁻act)

HCO3–act = 0.031 x pCO2 x 10(pH – 6.1)

Standard Bicarbonate (HCO₃⁻std)

Same as for earlier instruments.

Base Excess of Extracellular Fluid (BE(ecf))

In earlier instruments, this was (vv)
BE(ecf) = (1 – 0.004ctHb) x (HCO3–act – 24) + (9 + 0.3ctHb) x (pH - 7.4) –
0.3ctHb x (100 – O2SAT)/100

Base Excess of Blood (BE(B))

In earlier instruments, this was BE(vt)
BE(B) = (1 – 0.014ctHb) x (HCO3–act – 24) + (9.5 +1.63ctHb) x (pH – 7.4)

Oxygen Content (O₂CT)

O2CT = 1.39ctHb x O2SAT/100 + 0.003 pO2

Oxygen Saturation (Estimated)

Same as for earlier instruments.

Total Carbon Dioxide (ctCO₂)

ctCO2 = 0.031pCO2 + HCO3–act

Patient Temperature Correction

pH(T) = pH – 0.015 x (T – 37)
pCO2 same as for earlier instruments.
pO2(T) = pO2 x 10(A x (T – 37))
where A = 0.0052 + 0.027 x (1 – 10(–0.13 x (100 – O2SAT)))

RAPIDLab 348EX Operator’s Guide page 235

Operating Principles

Arterial-Alveolar Oxygen Tension Difference

Same as for earlier instruments.

Arterial-Alveolar Oxygen Tension Ratio

Same as for earlier instruments.

page 236 RAPIDLab 348EX Operator’s Guide

Revision History
10698292 Rev. E

Chapter/Appendix Description of Change

Table of contents Added headings “Summary and Explanation”,
“Shelf Life”, “Materials Provided”, “Special
Materials Required (Not Provided)”, “Reference
Ranges”, “IT Security”, “Disposal of the Analyzer”,
“Technical Assistance”, “Training”, “Limit of
Quantitation”, “RAPIDLab 348EX Parameter
Linearity”, “RAPIDLab 348EX Interfering
Substances”, “Irenat Interference”, "Method
Comparison – RL348EX Blood Gas", and "Method
Comparison – RL348EX Dialysis Fluid".

Introduction Added section “Summary and Explanation”.

Updated section “Intended Use of the RAPIDLab
348EX System” with testing population.

Handling Samples and Added section “Shelf Life”.

Reagents

System Operation Added section "Materials Provided" and "Special

Materials Required (Not Provided)”.

System Installation and Added electromagnetic caution statement in

Configuration section “Installation”.

Appendix A: Concepts and Updated section “Setting Reference Ranges” with

Reference Information information about values used for reference
ranges.
Added section “Reference Ranges”.
Added section “IT Security”, “Disposal of the
Appendix B: Warranty and
Analyzer”, and "Training".
Support Information
Updated section heading "Technical Assistance"
and added “EUDAMED” statement and
information about adverse incident to the user in
that section.

RAPIDLab 348EX Operator’s Guide page 237

 Chapter/Appendix Description of Change
Appendix E: References Updated section “References” with additional
literature references.

Appendix F: Specifications Added section “Limit of Quantitation”, “RAPIDLab

348EX Parameter Linearity”, “RAPIDLab 348EX
Interfering Substances", "Irenat Interference",
"Method Comparison – RL348EX Blood Gas", and
"Method Comparison – RL348EX Dialysis Fluid".

Appendix G: Symbols Updated “Serial Number” symbol.

Added “Device for near patient testing” symbol
with the description.

Updated web address to

* “siemens-healthineers.com/poc” in EC-REP.

* Indicates the changes are common and not included in any particular sections of this Operator’s Guide.

page 238 RAPIDLab 348EX Operator’s Guide

Index 239

Index
Numerics definition 19
guidelines for avoiding 18
1-point calibration 50 biweekly maintenance 62
2-point calibration 50 blockage
6-month maintenance 63 clearing 101
A clot 30
in drip tray connector drain hole,
accuracy on measured parameters in dialysis clearing 102
fluid mode 207 in pre-heater, clearing 101
Action List in probe, clearing 101
in sensor, clearing 102
displaying 163 in sensors, clearing 101
prompting for maintenance 62, 63 manifold, clearing 104
additional calibration, requesting 52 blood gases, measuring 224
addresses, Siemens 175 blood sample, collecting 25
agency standards 18 bottle tubing, replacing 87
air bubble bubble
under sensor 44 sample, analyzing 43
air bubble in reference sensor 87 sample, measuring 43
amperometry 216 under sensor 44
anion gap (AnGap) 234 bubble in reference sensor 87
arterial blood source 27 buffer bottles, separating 64
automatic calibration 50 buffer label, dating 67
buffer pack
B
agitating 21
bar-code reader replacing 22
standard mode 147 C
barcode reader
Ca++ sensor 220
cautions 22
installing 147 calcium adjustment for pH 234
presentation mode 147 calculated parameters
barometer, calibrating 51 blood gas mode, specifications 192
base excess, principles of operation 230 dialysis fluid mode 207
principles of operation 229
beeper
selecting 155
sounding during data entry 138 calculations, default values used 38
sounding during data recall 138
turning on or off 156 calibration
bicarbonate ion 229 1-point 50
2-point 50
biohazard

RAPIDLab 348EX Operator’s Guide

240 Index

automatic 50 Clinical and Laboratory Standards Institute

barometer 51 (CLSI) 18
configuring 151 clot blockage 30
default setup options and values 165
drift 114 collecting patient samples 36, 38
failure 112 collection device
failure, diagnosing and fixing 53 capillary tube 28
gases 165 heparinized syringe 28
no endpoint 117 sample 27
options 165 vacuum tube system 28
outside range 120
communication
overview 163
recalling and printing summary data 165 configuring options 156
requesting additional 52, 166 protocols 185
screen 34 compatibility, electromagnetic 18
selecting the method 49 compressed gas cartridges, handling 22
summary data 52, 165
system 49 conditioner, Siemens 21
calibration data, recalling and printing 52 conditioning sensors 68
calibration summary conductivity 217
daily automatic printing 139 configuring the system 141
data management 139 controls, precision 201
printing 113 correlation, adjusting 152
recalling and printing 52
viewing 112 ctHb(est) 232
calibration timing D
fixed or flexible 49
daily maintenance 60
selecting 49, 50
data
cancel sample analysis 44
entering 34
capillary blood, sample source 27
entering patient data for recalled sample 46
capillary sample, analyzing 38 ports 185
capillary tube, blood collection device 28 printing recalled results 47
carbon dioxide, total 232 recalling 45
viewing recalled data 45
cartridges, handling gas cartridges 22
data communication
Caution
protocol 185
electromagnetic 141
data communication format
Centers for Disease Control (CDC) 18
LIS 1 (default) 186
certification LIS 2 (default) 186
safety 18 LIS 3 (default) 186
TUV 18 data management 139
Cl– sensor 221 data ports 185
dating the buffer label 67

RAPIDLab 348EX Operator’s Guide

Index 241

Declaration of Conformity 18 exclusions, warranty 173

deproteinizer, preparing 32 external device, interfacing 185
deproteinizing sensors 67 F
deselection, sensor 164
Field Service Report 171
dialysis fluid mode
fixed calibration timing 49
calculated parameters 207
measured parameters 206 flea, mixing 28
measured parameters, accuracy 207 flexible calibration timing 49
measurement range 206 fluid detectors, location 134
sample size 207
within-run precision 207 fluidics failure 123
dialysis fluid sample fuse, replacing 105
analyzing 41 G
collecting 27
sample size 207 gas cartridge
dimensions, system 205 changing 72
direct parameters, dialysis fluid mode 206 handling 22
installing 146
Disinfect routine venting 73
disinfectants to use 69 gas exchange indices 233
using 69
gas flow rate, checking 74
disinfectants 69
gas regulator assembly 73
display specifications 204
gas values
Disposal of the Analyzer 174
calibrating for pCO2 and pO2 sensors 51
draining the system 71 entering 49
drip tray grounding the system 22
blockage, clearing 102
cleaning or replacing 88 H
E halothane, caution 26
Hct
electrical hazard, protections 22
measuring 224
electrolytes sensor 223
measuring, principles of operation 224 sensor, cutaway view 224
electromagnetic compatibility (EMC) 18 Hct slope check, in calibration timing
Electronics routine 135 modes 50
emptying the waste bottle 64 Hct slope, checking 53
environmental conditions 205 heater
environmental requirements 142 failure 129
specifications 204
erroneous result, possible causes 28
Heater routine 135
every other week maintenance 62
hemolysis, preventing 25

RAPIDLab 348EX Operator’s Guide

242 Index

Henderson-Hasselbalch equation 224 accessing functions 60

biweekly 62
I daily 60
inner electrode, replacing 83 frequency 60
overview 59
installation preparations 60
caution 141 prompted by Action List 62, 63
procedure 142 quarterly 63
installing the system 141 semiannual 63
setting prompts 154
intended use
weekly 61
reagents 31 managing 139
system 23
manifold
interfacing to external devices 185
clearing a blockage 104
IT Security
master password 157
Security White Paper 174
Material Safety Data Sheet, reagents 31
K measured parameters
K+ sensor 220 blood gas mode 191
key operator 172 dialysis fluid mode 206
dialysis fluid mode, accuracy 207
L measurement block door, opening 81
language, changing 158 Measurement Block routine 130
leukocyte counts, effect on Hct values 26 measurement parameters, selecting 155
limitations of Siemens warranty 174 measurement range
LIS 1 blood gas 191
dialysis fluid mode 206
data format, default 186
description 185 measurement sensors
LIS 2 installing 143
refilling 81
data format, default 186
refilling or replacing 80
description 186
reinstalling 82
LIS 3 removing 81
data format, default 186 measurement time 204
description 186
measuring 43
loading printer paper 90
menu map 35, 162
lubricating the rollers 78
menu password 169
M Method 198
main menu options 163 Method Comparison
maintaining the system 59 RL348EX Dialysis Fluid 198
maintenance method comparison 193
micro sample mode, reference tables 201

RAPIDLab 348EX Operator’s Guide

Index 243

micro sample, measuring 42 calculated, dialysis fluid mode

mixing flea, using 28 specifications 207
calculated, principles of operation 229
MSDS, reagent 31 calculated, specifications, blood gas
mode 192
N measured, dialysis fluid mode
Na+ sensor 219 specifications 206
measured, specifications, blood gas
National Committee for Clinical Laboratory mode 191
Standards (NCCLS), see Clinical and
Laboratory Standards Institute (CLSI) parts replacement 172

National Institute of Health (NIH) 18 password

NCCLS 18 entering 35
master 157
Nernst equation 215 menu 169
nitrous oxide, caution 26 patient data for recalled sample
Not Ready message, responses 112 entering 46
O patient samples
collecting samples 36, 38
operating handling techniques for whole blood 29
precautions 20 sample devices 27
principles 215 patient temperature correction 232
system 33
pCO2 and pO2 sensors
operating setup
calibrating gas values 51
changing the QC default 56
configuring 149 pCO2 sensor 221
QC default 56 pCO2 sensor, cutaway view 222
operator ID pH
entering 35 calcium adjustment 234
field length 35 measuring 224
requiring 169 pH Sensor
operator, key 172 cutaway view 219
options,selecting 34 pH sensor
orderable spare parts 178 description 218
orderable supplies 177 pO2 sensor 222
ordering information 177 pO2 sensor, cutaway view 223
OSHA requirements 172 pO2/FIO2 Ratio 234
oxygen content 231 port, data 185
oxygen saturation (estimated) 231 potentiometry 215
P power
cord, grounding 22
paper, replacing in printer 90 faultsystem
parameters

RAPIDLab 348EX Operator’s Guide

244 Index

setup fault 111 protocol, data communication

requirements 205 LIS 1 186
powering up the system 149 LIS 2 186
precautions, operating 20 LIS 3 186
pump rotor mouldings, removing 77
precision on controls 201
pump rotor, removing 77
precision, whole blood 199
pump tubing
pre-heater
changing 75
blockage, clearing 101
dating the label 78
replacing the tube 98
installing new 78
presentation mode, barcode reader 147 sample and reagent, connecting 144
Prime routine 71 twisted 79
priming the system 71 pump tubing, sample pump 75
principles of operation 215 Q
printer
QC data
configuring options 151
specifications 204 managing 139
troubleshooting 129 QC operating setup
printer cover, opening 90 changing the default 56
printer paper default 56
loading 91 QC prompts setup 150
replacing 90 QC ranges setup 149
probe QC samples
and housing, reassembling 95 analyzing 56
and tubing, replacing 92 handling 55
blockage, clearing 101 quality control (QC)
probe connector procedures 55
disconnecting 93 quarterly maintenance 63
probe cover 36
R
probe housing
reassembling 95 Ready screen 163
removing 93 reagent pump tubing
replacing 92, 96 changing 76
probe lever position 36, 92 installing new 79
probe protector, replacing 97 removing 77
probe shaft mechanism, greasing 94 reagents
probe sleeve 36 active ingredients 31
changing 65
protection from biohazards 18
checking 65
protocol handling and preparation 32
data communication 185 installing 145

RAPIDLab 348EX Operator’s Guide

Index 245

intended use 31 Run Test Sample routine 134

orderable 183
overview 30 S
positioning 66 safety certification 18
storage 31
storage requirements 206 safety information 17
using and replacing 21 sample
recalled result, printing 47 analyzing dialysis fluid 41
recalled sample data cancel analysis 44
collection devices 27
entering patient data 46
handling 28
viewing 45
handling and storing human whole blood
recovery, whole blood 199 samples 29
red stripe on printer paper 90 handling specifications and precautions 204
possible causes of erroneous results 28
reference inner electrode, replacing 83
storing 28
reference ranges syringe, analyzing 36
default 150 volume 204
setting 150 sample data 139
setting, all measured parameters 167
entering patient data for recalled sample 46
reference reservoir, refilling 86 recalling 45
reference reservoir, replacing the cap 86 viewing recalled data 45
reference sensor sample devices, patient samples 27
installing 144 Sample Flow routine 134
principles of operation 217 sample not detected 127
removing 84
sample pump tubing
replacing 83
replacing while replacing probe 96 changing 75
trapped air bubble 87 installing new 79
removing 76
reference sensor (cutaway view) 218
sample size, dialysis fluid mode 207
references 187
sample source
replacing parts 172
arterial blood 27
requirements
capillary blood 27
environmental 142 venous blood 27
OSHA 172 sample with a bubble 43
power 205
sampling fault 127
result
screen calibration 34, 54
printing recalled results 47
syringe sample, interpreting 40 screen, overview 161
Roll Printer routine 136 security, configuring 157
rollers semiannual maintenance 63
cleaning 77 sensor
lubricating 78 air bubble 44

RAPIDLab 348EX Operator’s Guide

246 Index

blockage, clearing 101, 102 starting up the system 149

Ca++ 220 STAT, analyzing priority sample 36
Cl- 221
conditioning 68 Stop System routine 70
deproteinizing 67 stopping (shutting down) the system 107
deselection 164 stopping the system (Stop System
Hct 223 routine) 70
Hct (cutaway view) 224
storage, reagents 31
K+ 220
Na+ 219 Summary and Explanation
pCO2 (cutaway view) 222 semi-automated 24
pH 218 summary data
pH (cutaway view) 219
pO2 222 calibration, printing 165
pO2 (cutaway view) 223 managing calibration summaries 139
reference, (cutaway view) 218 supplies
reference, principles of operation 217 orderable 177
removing 81 using and replacing 21
Sensors routine 137 support information 171
service delivery policy 171 suspect patient results 125
service setup, configuring 158 symbols 209
settings icon 163 comprehensive list 209
setup report, printing 157 user interface 213
setup, system 141 syringe sample, analyzing 36
short sample syringe, 28
analyzing 43 system
measuring 43 back panel 161
shutting down the system 107 calibration 49
Siemens Conditioner 21 configuration 141
configuring 168
Siemens contacts and addresses 175 data management 139
six-month maintenance 63 front view 159
slope installing and configuring 141
maintenance 59
drift 114 operation 33
outside range 120 overview 159
slope check, Hct 50 QC 55
slope no endpoint 117 quality control 55
safety 17
spares 178
setup 141
specifications, system 191 shutdown 107
standard mode, bar-code reader 147 size and weight 205
standards, agency 18 specifications 191
start-up 149
standby mode 47 symbols 209

RAPIDLab 348EX Operator’s Guide

Index 247

troubleshooting 111 troubleshooting routines 129

warranty and support 171 turning on the system 149
system information parameters, TUV certification 18
entering 158
twisted tubing 79
system setup fault 111
system setup, configuring 154 U
T USB memory stick, installing 149

Technical Assistance V
EU Member State 175 vacuum tube blood collection system 28
EUDAMED 175
venous blood source 27
technical support 171
venting the gas cartridges 73
temperature
Virkon 69
correction, patient 232
default in calculations 38 W
operating specifications 204
warm up specifications 108
theory of operation 215
warmup, what you can do 34
timing, calibration 49, 50
warranty
total carbon dioxide 232
and support 171
touch screen design changes and retrofitting 172
calibrating 54 exclusions 173
using 161 limitations 174
touch screen, calibration 34 parts replacement 172
period 171
Training
service call extent 171
country laws and regulations 175 service outside normal business hours 172
troubleshooting service, business hours 171
calibration or slope drift 114 standard instrument warranty 171
calibration or slope no endpoint 117 wash bottle, replacing 22
calibration or slope outside range 120 waste bottle
Electronics routine 135
emptying 64
fluidics failure 123
replacing 64
general procedures 111
heater failure 129 weekly maintenance 61
heater routine 135 whole blood, precision and recovery 199
Measurement Block routine 130 within-run precision, dialysis fluid mode 207
printer 129
Roll Printer routine 136
Run Test Sample routine 134
Sample Flow routine 134
sample not detected or sampling fault 127
Sensors routine 137
suspect patient results 125

RAPIDLab 348EX Operator’s Guide

248 Index

RAPIDLab 348EX Operator’s Guide