ABL90 Flex Instruction Manual

ABL90 FLEX
Instructions for use

From software version 3.1
Contents
1. Introduction
Intended use............................................................................................................ 1
Limitations of use............................................................................................ 2
About limitations of use..............................................................................................2
Measurement of FHbF................................................................................................ 2
Operator training requirements................................................................................... 2
About this document.................................................................................................. 2
Documentation..........................................................................................................3
About hazards...........................................................................................................3
General warning and cautions..................................................................................... 3
Reference................................................................................................................. 3
2. Getting to know the analyzer
Overview of the analyzer.................................................................................. 5

Front view................................................................................................................ 5
Side and back view.................................................................................................... 6
Consumables............................................................................................................ 6
To see details about installed consumables....................................................................7
Is the analyzer ready for use?........................................................................... 7
Three important conditions......................................................................................... 7
Parameter tab colors..................................................................................................8
To access the Analyzer status screen............................................................................8
The Analyzer status screen......................................................................................... 9
Analyzer status - Traffic light colors..............................................................................9
Messages................................................................................................................. 9
To find and troubleshoot messages in the Analyzer status screen................................... 11
Is the analyzer operating on battery power?................................................................ 11
Common tasks............................................................................................... 12
To log on................................................................................................................ 12
To scan a barcode.................................................................................................... 12
To enter text........................................................................................................... 13
To select/deselect a check button...............................................................................13
To save changes...................................................................................................... 13
Menu............................................................................................................ 14
Menu structure........................................................................................................ 14
Data logs...................................................................................................... 15
About data logs....................................................................................................... 15
Overview of data logs...............................................................................................15
To access data logs.................................................................................................. 15
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Contents ABL90 FLEX: Instructions for use
3. Patient sample analysis
General warnings and cautions.................................................................................. 17

Anticoagulants........................................................................................................ 17
Good results come from good samples.............................................................. 18
What is a good sample?............................................................................................18
To get a good sample............................................................................................... 18
To mix a sample on the analyzer................................................................................ 19
Storage recommendations........................................................................................ 19
Pre-registration of samples.............................................................................. 20
About sample pre-registration................................................................................... 20
To pre-register a sample........................................................................................... 20
Analyzing patient samples............................................................................... 20
General information for obtaining successful patient sample analyses............................. 20
To analyze a sample from a syringe............................................................................21
To analyze a sample from a capillary tube................................................................... 22
To analyze a sample from a test tube......................................................................... 24
To get calculated values for FShunt and ctO2(a-v̄)........................................................ 26
Entering and editing data in the Patient identification screen................................ 26
The Patient identification screen.................................................................................26
To change the report layout in the Patient identification screen...................................... 27
To request patient data automatically when connected to a LIS/HIS system.....................27
To request patient data using Patient lookup................................................................27
To edit data in the Patient identification screen............................................................ 28
Patient results............................................................................................... 28
To find a patient result..............................................................................................28
Symbols on patient results........................................................................................ 28
About ranges and critical limits.................................................................................. 29
Status in the Patient results log................................................................................. 29
To see messages on patient results............................................................................ 30
To troubleshoot messages on results.......................................................................... 30
To see the acid-base chart for a result........................................................................ 30
Reviewing and editing patient results................................................................ 30
To filter data from the Patient results log.....................................................................30
To see trends in a patient's results............................................................................. 31
To see the audit trail on a patient result...................................................................... 31
To add a note to a patient result ............................................................................... 31
To remove a parameter from a patient result............................................................... 31
To show a parameter in a patient result...................................................................... 32
Approval and rejection of patient results..................................................................... 32
To approve a patient result........................................................................................32
To reject a patient result........................................................................................... 32
Critical limit notification.................................................................................. 33
About Critical limit notification................................................................................... 33
To enable Critical limit notification.............................................................................. 33
To use Critical limit notification.................................................................................. 33
Pending results log...................................................................................................33
To access the Pending results log............................................................................... 34
Input fields for the Patient report layout......................................................................34
References..............................................................................................................34
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ABL90 FLEX: Instructions for use Contents
4. Replacements and maintenance
General warnings and cautions.................................................................................. 35

To order products for use with your analyzer............................................................... 35
Replacement intervals for consumables and Inlet Connector Gasket................................35
Replacements.................................................................................................... 36
Solution Pack................................................................................................. 36
To see the Solution Pack status..................................................................................36
To replace the Solution Pack...................................................................................... 36
To release the Solution Pack manually........................................................................ 38
Can a Solution Pack be used again?............................................................................38
Status logs............................................................................................................. 39
To print Solution Pack status logs............................................................................... 39
To export Solution Pack status logs............................................................................ 39
Sensor Cassette............................................................................................. 39
To see the Sensor Cassette status.............................................................................. 39
To replace the Sensor Cassette.................................................................................. 39
Calibration frequency after a Sensor Cassette replacement ........................................... 40
Can a Sensor Cassette be used again?........................................................................41
Status logs............................................................................................................. 41
To print Sensor Cassette status logs........................................................................... 41
To export Sensor Cassette status logs.........................................................................41
Thermal printer paper..................................................................................... 42
To replace the thermal printer paper...........................................................................42
Protection of printed data......................................................................................... 42
Inlet Gasket Holder........................................................................................ 43
To replace the Inlet Gasket Holder..............................................................................43
Inlet Probe.................................................................................................... 44
To replace the Inlet Probe......................................................................................... 44
Inlet Connector Gasket................................................................................... 48
To replace the Inlet Connector Gasket........................................................................ 48
Inlet Module.................................................................................................. 50
To replace the Inlet Module....................................................................................... 50
Maintenance...................................................................................................... 52
Cleaning....................................................................................................... 52
Cleaning - when is it necessary?................................................................................ 52
To clean the inlet gasket........................................................................................... 52
To clean the Inlet Module.......................................................................................... 53
To clean the touch screen......................................................................................... 56
To clean the analyzer exterior....................................................................................56
Disinfecting................................................................................................... 56
Disinfection - when is it necessary?............................................................................ 56
To disinfect the touch screen .................................................................................... 57
To disinfect the analyzer exterior............................................................................... 57
To disinfect the fluid transport system........................................................................ 57
Battery......................................................................................................... 57
To recharge the analyzer battery................................................................................57
To install and service the battery................................................................................57
Disposal........................................................................................................ 58
To dispose of the analyzer.........................................................................................58
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Inlet Clip....................................................................................................... 58
Inlet Clip - when is it necessary to use one?................................................................ 58
To put an Inlet Clip on the Inlet Gasket Holder............................................................. 58
To remove the Inlet Clip from the Inlet Gasket Holder................................................... 60
Connecting peripherals................................................................................... 60
To connect a USB external keyboard / mouse.............................................................. 60
To connect a non-USB (PS/2) external keyboard or mouse............................................ 60
To connect an external barcode reader........................................................................61
To connect the analyzer to a network..........................................................................61
Reference............................................................................................................... 61
5. Quality control
Overview of quality control management.................................................................... 63

To find the status of QC measurements.......................................................................63
Symbols that show the status of QCs..........................................................................63
Automatic quality control management.................................................................. 63
About automatic quality control management.............................................................. 63
About system checks................................................................................................64
Overview of automatic quality management................................................................ 64
Built-in QC.........................................................................................................65
About built-in QC measurements................................................................................65
Built-in QC measurement frequency........................................................................... 65
To request an unscheduled built-in QC measurement.................................................... 66
Built-in QC results.......................................................................................... 66
Quality control management done by operators...................................................... 67
Quality control management that can be done by operators...........................................67
Ampoule-based QC measurements........................................................................68
QC solutions for ampoule-based measurements........................................................... 68
How to get good ampoule-based QC measurement results............................................ 68
To prepare a Radiometer QC ampoule for use.............................................................. 69
To do an ampoule-based QC measurement..................................................................71
To edit QC identification data.....................................................................................72
Ampoule-based QC results.............................................................................. 72
Calibration verification.........................................................................................74
About calibration verification..................................................................................... 74
Frequency of calibration verification........................................................................... 74
Stage 1 - Analyzing different levels of control solution......................................... 75
To prepare a Radiometer calibration-verification ampoule for use....................................75
To do a calibration-verification measurement............................................................... 76
Stage 2 - Using results to verify reportable ranges.............................................. 77
To find a calibration-verification measurement result.................................................... 77
Symbols on calibration-verification measurement results...............................................78
To temperature correct calibration-verification results based on Range+ QUALICHECK
measurements........................................................................................................ 78
To use temperature-corrected calibration-verification results..........................................79
Stage 3 - Changing reportable ranges............................................................... 79
To change the reportable range of parameters............................................................. 79
Reviewing QC statistics....................................................................................... 79
To find and print QC statistics.................................................................................... 79
QC plots................................................................................................................. 80
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To find a QC plot......................................................................................................81
To filter data from the Quality control log.................................................................... 81
To see trends in QC results........................................................................................81
WDC file export..............................................................................................81
About WDC............................................................................................................. 81
To export WDC files..................................................................................................82
Analyzing QC solutions in other modes.............................................................. 82
About analyzing QC solutions in other modes...............................................................82
To temperature correct results based on QUALICHECK5+ solutions................................. 82
6. Calibration
Calibrations - automatic and manual.......................................................................... 85

Identification of calibrations in screens....................................................................... 85
Manual calibration of the oximetry parameters.............................................................85
Frequency of automatic calibrations............................................................................85
To find the status of calibrations................................................................................ 86
Symbols that show the calibration status.................................................................... 86
Automatic calibrations.....................................................................................87
To request an unscheduled calibration from the Analyzer status screen........................... 87
To request an unscheduled calibration from the menu................................................... 87
Manual tHb calibrations................................................................................... 87
To do a tHb calibration..............................................................................................87
Calibration results.......................................................................................... 89
To find a calibration result......................................................................................... 89
Identification of calibrations in the Calibration log screen...............................................89
Understanding calibration results............................................................................... 90
To see messages on a calibration result...................................................................... 90
To troubleshoot messages on results.......................................................................... 90
Reviewing calibration results............................................................................ 90
To filter data from the Calibration log..........................................................................90
To see trends in calibration results............................................................................. 91
Status in the Calibration log screen............................................................................ 91
7. Troubleshooting
Troubleshooting - when is it necessary?...................................................................... 93

About guided troubleshooting.................................................................................... 93
To get out of Operator Action Needed mode.................................................................93
To get out of Troubleshooting needed mode.................................................................93
To get out of Intervention Required mode................................................................... 93
Troubleshooting modes - causes................................................................................ 93
To find and troubleshoot messages in the Analyzer status screen................................... 94
To flush the fluid transport system............................................................................. 95
Operator actions requested in analyzer messages............................................... 98
To request a tubing refill........................................................................................... 98
To request a liquid sensor adjustment.........................................................................98
To request a pump calibration....................................................................................98
To request a rinse.................................................................................................... 98
Troubleshooting Analyzer messages.................................................................. 98
To troubleshoot Analyzer messages............................................................................ 98
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Analyzer messages.................................................................................................. 98
Activity log.................................................................................................. 134
About the Activity log............................................................................................. 134
To troubleshoot messages in the Activity log.............................................................. 134
To see activities in the Activity log............................................................................ 134
To add a message to the Activity log.........................................................................134
To filter activities from the Activity log...................................................................... 134
Analyzer service........................................................................................... 134
For service............................................................................................................ 134
To find the installation number (serial number) of the analyzer.....................................135
To find the version of software installed.....................................................................135
8. Shutting down, moving and restarting the analyzer
Shutdown............................................................................................................. 137
Temporary shutdown of the analyzer............................................................... 137
When to do a temporary shutdown........................................................................... 137
To do a temporary shutdown................................................................................... 137
Long-term shutdown of the analyzer............................................................... 137
When to do a long-term shutdown............................................................................137
To do a long-term shutdown ................................................................................... 138
Storing the analyzer......................................................................................140
To store the analyzer.............................................................................................. 140
Moving the analyzer...................................................................................... 140
To move an analyzer that has a charged battery.........................................................140
To move an analyzer that does not have a battery...................................................... 140
Restarting the analyzer................................................................................. 140
To restart the analyzer after a temporary shutdown.................................................... 140
To restart the analyzer after a long-term shutdown.....................................................141
9. Setup
Setup menu structure.............................................................................................143

To print setups.......................................................................................................144
Managing operators...................................................................................... 144
To select the logon procedure.................................................................................. 144
Access profiles.......................................................................................................144
To edit an access profile.......................................................................................... 144
Anonymous use..................................................................................................... 145
To set up anonymous use........................................................................................145
Default operators................................................................................................... 145
To add an operator................................................................................................. 145
To remove an operator............................................................................................146
To set a logoff time for all operators......................................................................... 147
Centralized user management..................................................................................147
To set up centralized user management.................................................................... 147
Managing patient profiles............................................................................... 148
Patient profiles log................................................................................................. 148
To see the data saved in a patient profile...................................................................148
To find a patient profile........................................................................................... 148
To edit a patient profile........................................................................................... 148
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To add a new patient profile.................................................................................... 148

To delete a patient profile........................................................................................148
Analyzer operations........................................................................................... 149
To lock the analyzer............................................................................................... 149
To unlock the analyzer............................................................................................ 149
To lock/unlock parameters for measurement..............................................................149
To show a message on the analyzer screen................................................................149
Sample counter............................................................................................ 150
To see an overview of measurements and tests done on the analyzer............................150
Sample counter..................................................................................................... 150
To reset the counters in the User column...................................................................150
Analyzer settings.......................................................................................... 150
To set up corrective actions on system messages....................................................... 150
To enable data to be scanned from barcodes..............................................................151
To create a heading for printed data......................................................................... 151
To enable the screen saver...................................................................................... 151
To set the time and date......................................................................................... 151
To set the acoustic signals....................................................................................... 152
To mute all acoustic signals..................................................................................... 152
To change the screen language................................................................................ 152
To select a regional setting...................................................................................... 152
To set the barometric pressure.................................................................................153
To log all measurement activities..............................................................................153
Analysis setup.................................................................................................. 153
Analysis modes............................................................................................ 153
Syringe modes...................................................................................................... 153
To edit a syringe mode............................................................................................153
To create a new syringe mode..................................................................................154
To remove a measurement mode............................................................................. 155
To select a default measurement mode..................................................................... 155
To select a specific patient report layout for an analysis mode...................................... 156
To set up a calibration-verification mode................................................................... 156
To set up an ampoule QC mode................................................................................156
Capillary modes..................................................................................................... 157
To edit a capillary mode.......................................................................................... 157
Proficiency test modes............................................................................................ 157
To set up a proficiency test mode............................................................................. 158
Ranges and critical limits............................................................................... 158
About ranges and critical limits................................................................................ 158
About reference ranges...........................................................................................159
Reference range of measured parameters..................................................................159
Reference ranges for neonatal ctBil...........................................................................159
About critical limits.................................................................................................160
To set the limits for patient age groups..................................................................... 160
To set up reference ranges and critical limits..............................................................160
About reportable ranges..........................................................................................161
To set up reportable ranges..................................................................................... 161
About range of indication........................................................................................ 161
Sample pre-registration................................................................................. 161
About sample pre-registration..................................................................................161
To set up sample pre-registration............................................................................. 162
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Sample age evaluation.................................................................................. 162

About sample age evaluation................................................................................... 162
Maximum sample age.............................................................................................162
To set a maximum sample age.................................................................................162
Max sample age.....................................................................................................163
Patient report layouts.................................................................................... 163
About patient report layouts.................................................................................... 163
To create a patient report layout.............................................................................. 163
To change a patient result layout..............................................................................165
To create extra items for use in patient report layouts................................................. 166
To select a patient report layout as default................................................................ 166
To automatically change the temperature units.......................................................... 167
To edit a patient report layout..................................................................................167
To create a patient report layout for FShunt and ctO2(a-v)̄ ........................................... 168
Patient result settings................................................................................... 168
To set up automatic printing of acid-base charts......................................................... 168
Approval and rejection of patient results................................................................... 169
To enable patient result approval/rejection................................................................ 169
Parameter settings............................................................................................ 169
To show the parameter bar......................................................................................169
To hide the parameter bar....................................................................................... 169
To enable/disable a parameter................................................................................. 169
To set up measuring units for parameters..................................................................170
To repress a parameter........................................................................................... 170
To suppress out-of-range results.............................................................................. 170
To fix the number of decimals used in blood-gas results.............................................. 170
To enable HbF corrections....................................................................................... 171
To enable the estimation of derived parameters......................................................... 171
Editing the slope and offset of a parameter...................................................... 172
Operator-defined corrections (offset and slope).......................................................... 172
Recommendations about samples to use................................................................... 173
Limits for slope and offset values............................................................................. 173
To edit the offset and slope for a parameter...............................................................174
Calibration settings....................................................................................... 175
Details about calibration frequency........................................................................... 175
To edit the calibration schedule................................................................................ 175
To link the built-in QC schedule to the calibration schedule.......................................... 176
To set up corrective actions for overdue scheduled calibrations.....................................177
Quality control.................................................................................................. 177
Glossary of quality control terms.............................................................................. 177
Registration of QC solutions........................................................................... 178
Why is it necessary to register QC solutions?............................................................. 178
About registration of QC solutions............................................................................ 178
To register a Radiometer QC solution for ampoule-based QC measurements...................178
Data saved during registration of Radiometer QC solutions.......................................... 178
To register a non-Radiometer QC solution..................................................................179
Data saved during registration of non-Radiometer QC solutions.................................... 180
Quality control solutions................................................................................ 180
To set up the temperature field for QC measurements................................................. 180
Scheduled QC measurements......................................................................... 181
To schedule ampoule-based QC measurements.......................................................... 181
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To edit the schedule for ampoule-based QC measurements.......................................... 181

Built-in QC measurement frequency......................................................................... 182
To edit the schedule for built-in QC measurements..................................................... 182
To request ampoule-based QC measurements after replacements................................. 184
Corrective actions on QC results..................................................................... 184
To set up corrective action for errors in QC results...................................................... 184
To set up corrective actions for overdue scheduled QC measurements........................... 185
To apply operator-defined corrections to QC results.................................................... 185
To set up corrective action for errors in built-in QC measurements................................ 185
QC statistics................................................................................................ 186
To set up automatic print of built-in QC statistics........................................................ 186
Statistical factor.....................................................................................................186
To set the statistical factor...................................................................................... 186
Westgard Rules............................................................................................ 186
About Westgard Rules.............................................................................................186
Types of Westgard Rule ..........................................................................................186
Description of the lines used in Westgard rule illustrations........................................... 186
Westgard rules and corrective actions....................................................................... 187
To set up and enable Westgard Rules........................................................................ 188
To disable/enable Westgard rules............................................................................. 189
RiLiBÄK rules............................................................................................... 189
About RiLiBÄK rules................................................................................................189
To add a new RiLiBÄK rule....................................................................................... 189
To apply all RiLiBÄK rules........................................................................................ 190
To edit a RiLiBÄK rule............................................................................................. 190
To remove a RiLiBÄK rule........................................................................................ 191
Analyzer-specific control ranges...................................................................... 191
About analyzer-specific control ranges...................................................................... 191
How to establish analyzer-specific control ranges....................................................... 191
Stage 1: To do 20 ampoule-based QC measurements..................................................192
Stage 2: To enable the use of fixed standard deviations.............................................. 192
Stage 3: To use the analyzer to change control ranges to analyzer-specific control
ranges..................................................................................................................192
To manually change control ranges to analyzer-specific control ranges.......................... 193
Maintenance setup............................................................................................ 194
About mandatory and operator-defined activities........................................................194
Mandatory maintenance activities................................................................... 194
Other activities...................................................................................................... 194
To schedule other activities......................................................................................195
To set up corrective action for overdue Other activities................................................195
Operator-defined activities............................................................................. 196
Operator activities..................................................................................................196
To set up an operator activity.................................................................................. 196
To set up corrective action for pending operator activities............................................ 196
To delete an operator activity...................................................................................196
Maintenance planning....................................................................................196
To plan maintenance activities................................................................................. 196
Replacement warnings.................................................................................. 197
To set up replacement warnings............................................................................... 197
Note fields................................................................................................... 197
To create standard texts for use in Note fields............................................................ 197
To edit standard texts for use in Note fields............................................................... 197
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To delete standard texts for use in Note fields............................................................ 198

Communications........................................................................................... 198
To set up a LIS/HIS connection................................................................................ 198
To set up a AQURE/RADIANCE connection................................................................. 198
Patient data from a LIS/HIS or AQURE/RADIANCE system........................................... 199
To set up automatic requests for patient data............................................................ 199
To set up automatic transmission of data to a system................................................. 199
To enable manual patient data requests using Patient lookup....................................... 199
To access the RADIANCE system from the analyzer.....................................................200
To set up a QA Portal connection.............................................................................. 200
Printers....................................................................................................... 200
To set up automatic printing.................................................................................... 200
To install an external printer for the analyzer............................................................. 201
To edit the name of a printer................................................................................... 201
Data logs and archives.................................................................................. 201
About data logs and archived data logs..................................................................... 201
To set up automatic archiving.................................................................................. 202
File format of exported data logs and archived data logs............................................. 202
To export data logs.................................................................................................202
To export data from Archived data logs..................................................................... 203
To create disc space by exporting and deleting archives.............................................. 203
To import archived data logs....................................................................................203
Data backup and restoration.......................................................................... 204
Backup................................................................................................................. 204
Destinations for backup data................................................................................... 204
To schedule automatic backups................................................................................ 204
To do a manual backup........................................................................................... 204
To restore data from a backup................................................................................. 204
Saving and loading setups............................................................................. 205
To save the setup...................................................................................................205
To load a setup...................................................................................................... 205
To restore Radiometer default settings...................................................................... 205
Radiometer default settings........................................................................... 206
Operators and profiles - default settings....................................................................206
Alarm sound (acoustic signal) settings for events - default settings...............................207
Language - default setting.......................................................................................207
Analysis setup – default settings.............................................................................. 207
Parameters - default settings................................................................................... 209
Measurement units - default settings........................................................................ 209
Calibration schedule - default settings.......................................................................211
Quality control setups - default settings.................................................................... 211
Replacement setups - default settings.......................................................................211
Communication setup - default settings.................................................................... 212
User-defined patient data items - default settings.......................................................212
Corrective actions – default settings......................................................................... 213
Miscellaneous setup - default settings....................................................................... 213
Printer setup - default settings.................................................................................214
Automatic printing - default settings......................................................................... 214
Automatic archiving - default settings....................................................................... 214
Automatic backup - default setting........................................................................... 214
Setups with no default settings................................................................................ 214
References............................................................................................................ 215
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10. Performance characteristics
Measured parameters - definitions............................................................................217

About performance characteristics.................................................................. 218
Overview of performance characteristics................................................................... 218
Uncertainty in performance characteristics................................................................ 218
To convert an uncertainty at a 68 % confidence level.................................................. 219
Bias..................................................................................................................... 219
Repeatability and reproducibility.............................................................................. 219
Coefficient of variation (CV %).................................................................................220
Confidence intervals............................................................................................... 220
Total analytical error...............................................................................................220
About performance tests................................................................................221
Test conditions.......................................................................................................221
Reference methods/materials.................................................................................. 222
Performance test results................................................................................ 223
Rounding rules...................................................................................................... 223
pH performance test results.................................................................................... 223
pCO2 performance test results................................................................................. 224
pO2 performance test results................................................................................... 224
cK+ performance test results................................................................................... 225
cNa+ performance test results................................................................................. 225
cCl– performance test results...................................................................................226
cCa2+ performance test results................................................................................ 226
cGlu performance test results.................................................................................. 227
pO2 levels - how they affect cGlu results................................................................... 229
cLac performance test results.................................................................................. 229
ctHb performance test results.................................................................................. 230
sO2 performance test results....................................................................................231
FO2Hb performance test results............................................................................... 232
FCOHb performance test results...............................................................................232
FMetHb performance test results..............................................................................233
FHHb performance test results.................................................................................234
FHbF performance test results................................................................................. 235
ctBil* performance test results.................................................................................235
Linearity study - study design........................................................................ 236
Linearity study.......................................................................................................236
Linearity study - results.......................................................................................... 236
Graphical presentation of test results and first order models........................................ 237
Interference test results................................................................................ 242
Interference tests.................................................................................................. 242
pH/blood gas.........................................................................................................242
Electrolytes........................................................................................................... 243
Metabolites........................................................................................................... 247
Oximetry parameters..............................................................................................251
ctBil sensitivity for MCHC variations.......................................................................... 257
Alternative presentation of interference results................................................. 259
pH/blood gas (alternative presentation).................................................................... 259
Electrolytes (alternative presentation).......................................................................259
Metabolites (alternative presentation)....................................................................... 261
Oximetry parameters (alternative presentation)......................................................... 264
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External test results...................................................................................... 269

Study design - precision/reproducibility.....................................................................269
ABL90 FLEX precision - syringe study - site 1.............................................................270
ABL90 FLEX precision - syringe study - pooled data.................................................... 276
ABL90 FLEX Precision - capillary study - site 1........................................................... 278
ABL90 FLEX precision - capillary study - site 3........................................................... 280
ABL90 FLEX precision - capillary study - site 5........................................................... 283
ABL90 FLEX precision - capillary study - pooled data...................................................285
Method comparison studies with predicate devices......................................................287
ABL90 FLEX method comparison study results - syringe mode - site 1...........................287
ABL90 FLEX method comparison study results - syringe mode - pooled data.................. 290
Graphical presentation of POC comparison test results - syringe mode.......................... 291
ABL90 FLEX method comparison study results - capillary mode - site 1......................... 297
ABL90 FLEX method comparison study results - capillary mode - pooled data.................300
Graphical presentation of POC comparison test results - capillary mode......................... 301
Traceability.................................................................................................. 307
Traceability to the primary standards at Radiometer....................................................307
pH traceability....................................................................................................... 307
pCO2 and pO2 traceability........................................................................................308
cK+ and cNa+ traceability........................................................................................ 308
cCa2+ traceability................................................................................................... 308
cCl– traceability..................................................................................................... 308
cGlu traceability.....................................................................................................309
cLac traceability.....................................................................................................309
ctHb traceability.....................................................................................................309
Saturation – sO2 = 100 % – traceability.................................................................... 309
Saturation – sO2 = 0 % – traceability....................................................................... 309
FCOHb – normal value - traceability..........................................................................309
FCOHb – 100 % - traceability.................................................................................. 310
FMetHb traceability................................................................................................ 310
FHbF traceability.................................................................................................... 310
Hct traceability...................................................................................................... 310
ctBil* traceability .................................................................................................. 310
References............................................................................................................ 311
11. Derived and input parameters
Parameter types.................................................................................................... 313

Parameter symbols.................................................................................................313
Input parameters – definitions and acceptable values................................................. 313
Derived parameters................................................................................................314
Default values of parameters................................................................................... 315
Definitions of derived parameters................................................................... 316
Acid-base derived parameters – definitions................................................................316
Oximetry derived parameters – definitions................................................................ 317
Oxygen derived parameters - definitions................................................................... 317
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Electrolyte derived parameters – definitions...............................................................319

Data necessary to derive electrolyte parameters........................................................ 319
Calculation of derived parameters................................................................... 319
Sample type..........................................................................................................319
Units and symbols used in equations........................................................................ 320
Equations........................................................................................................ 320
Equations for acid-base parameters................................................................ 320
pH(T) - equation 1................................................................................................. 320
cH+(T) - equation 2................................................................................................320
pCO2(T) - equation 3.............................................................................................. 321
cHCO3–(P) - equation 4...........................................................................................321
cBase(B) - equation 5.............................................................................................321
cBase(B,ox) - equation 6.........................................................................................321
cBase(Ecf) - equation 7.......................................................................................... 321
cBase(Ecf,ox) - equation 8...................................................................................... 321
cHCO3–(P,st) - equation 9........................................................................................ 322
ctCO2(P) - equation 10........................................................................................... 322
ctCO2(B) - equation 11........................................................................................... 322
pH(st) - equation 12...............................................................................................322
Equations for electrolyte parameters............................................................... 322
Anion Gap, K+ equation 43...................................................................................... 322
Anion Gap - equation 44......................................................................................... 323
cCa2+(7.4) - equation 45........................................................................................ 323
Equations 46 and 47...............................................................................................323
mOsm - equation 48.............................................................................................. 323
Equations for oxygen parameters.................................................................... 323
pO2(T) - equation 14.............................................................................................. 323
pO2(A) - equation 15.............................................................................................. 324
pO2(A,T) - equation 16........................................................................................... 324
pO2(a)/FO2(I) - equation 17.................................................................................... 324
pO2(a,T)/ FO2(I) - equation 18................................................................................ 324
p50 - equation 19.................................................................................................. 324
p50(T) - equation 20.............................................................................................. 325
p50(st) - equation 21............................................................................................. 325
pO2(A-a) - equation 22........................................................................................... 326
pO2(A-a,T) - equation 23........................................................................................ 326
pO2(a/A) - equation 24........................................................................................... 326
pO2(a/A,T) - equation 25........................................................................................ 326
pO2(x) or px - equation 26...................................................................................... 326
pO2(x,T) - equation 50........................................................................................... 327
ctO2 - equation 27................................................................................................. 327
ctO2(a-v̄) - equation 28.......................................................................................... 328
BO2 - equation 29.................................................................................................. 328
ctO2(x) or cx - equation 30...................................................................................... 328
̇ 2 - equation 31.................................................................................................. 328
DO
Q̇t - equation 32.................................................................................................... 329
̇ 2 - equation 33.................................................................................................. 329

VO
FShunt - equation 34..............................................................................................329
FShunt(T) - equation 35......................................................................................... 330
RI - equation 36.................................................................................................... 331
RI(T) - equation 37................................................................................................ 331
xiii
Qx - equation 38.................................................................................................... 331

V(B) - equation 42................................................................................................. 332
VCO2/V(dry air) - equation 51................................................................................. 332
VO2/V(dry air) - equation 52................................................................................... 332
Equations for oximetry parameters................................................................. 332
FHHb - equation 41................................................................................................ 332
FO2Hb - equation 40...............................................................................................332
sO2 - equation 39...................................................................................................332
Hct - equation 13................................................................................................... 333
FHbF - equation 49................................................................................................ 333
Converting results to other units.............................................................................. 334
Oxyhemoglobin dissociation curve...................................................................335
ODC equations...................................................................................................... 335
The ODC reference position..................................................................................... 336
The ODC displacement............................................................................................336
The actual ODC position..........................................................................................337
To determine the actual displacement....................................................................... 338
Coordinates on the ODC..........................................................................................339
References............................................................................................................ 340
12. Principles of operation
General construction..................................................................................... 341

Sensors................................................................................................................ 341
General measurement principles..................................................................... 341
Introduction.......................................................................................................... 341
Activity vs. concentration........................................................................................ 342
Fluid transport system............................................................................................ 342
Measurement process............................................................................................. 344
Rinse process........................................................................................................ 344
Calibration................................................................................................... 344
Definition.............................................................................................................. 344
Frequency.............................................................................................................344
Calibration solutions............................................................................................... 344
The calibration equation................................................................................ 345
About the calibration equation................................................................................. 345
Plotting a calibration line......................................................................................... 345
Sensitivity, status and drift............................................................................ 345
Sensitivity.............................................................................................................345
Status.................................................................................................................. 347
Drift..................................................................................................................... 347
Reference electrode...........................................................................................347
Background information - reference electrode...................................................347
Purpose................................................................................................................ 347
Fixed potential.......................................................................................................347
Use ..................................................................................................................... 348
Construction - reference electrode.................................................................. 348
Construction..........................................................................................................348
pH and electrolyte sensors................................................................................. 348
Construction - pH and electrolyte sensors........................................................ 348
Construction..........................................................................................................348
xiv
Measurement principles - pH and electrolyte sensors......................................... 349

Potentiometric measurement principle...................................................................... 349
Electrode chain...................................................................................................... 349
Electrode chain potential......................................................................................... 350
Unknown potential................................................................................................. 350
Ion-sensitive membrane......................................................................................... 350
Nernst equation..................................................................................................... 350
Activity and concentration....................................................................................... 351
Calibration - pH and electrolyte sensors........................................................... 351
Calibrations of pH and electrolyte sensors................................................................. 351
Calculation of pH and electrolytes sensitivity..............................................................351
Measurement - pH and electrolyte sensors....................................................... 351
Calculation of pH and electrolyte values.................................................................... 351
Sensor response stability........................................................................................ 352
pCO2 sensor..................................................................................................... 352
Construction - pCO2 sensor............................................................................ 352
Construction..........................................................................................................352
Measurement principle - pCO2 sensor.............................................................. 353
Electrode chain...................................................................................................... 353
Electrode chain potential......................................................................................... 353
Measurement process in the pCO2 sensor.................................................................. 353
Calibration - pCO2 sensor...............................................................................354
Calibrations of the pCO2 sensor ...............................................................................354
Calibration levels................................................................................................... 354
Calculation of pCO2 sensitivity................................................................................. 354
Measurement - pCO2 sensor...........................................................................355
Calculation of pCO2 values...................................................................................... 355
Sensor response stability........................................................................................ 355
pO2 sensor....................................................................................................... 355
Measurement principle - pO2 sensor................................................................ 355
Optical system for pO2............................................................................................355
Measurement sequence.......................................................................................... 356
Calculations.......................................................................................................... 356
Calibration - pO2 sensor................................................................................ 356
Overview of pO2 calibrations....................................................................................356
Sensitivity.............................................................................................................356
Status.................................................................................................................. 357
Measurement - pO2 sensor.............................................................................357
Calculation of pO2 values........................................................................................ 357
Metabolite sensors............................................................................................ 358
Construction - metabolite sensors................................................................... 358
Construction..........................................................................................................358
Zero current..........................................................................................................358
Calibration - metabolite sensors......................................................................359
Calculation of sensitivity......................................................................................... 359
Measurement - metabolite sensors.................................................................. 359
Calculation of metabolite values............................................................................... 359
Sensor response stability of the metabolite sensors.................................................... 359
Measurement principle - metabolite sensors..................................................... 360
Amperometric measurement principle....................................................................... 360
Electrode chain...................................................................................................... 360
xv
Measurement process............................................................................................. 360

ctHb and derivates............................................................................................ 361
Description of the optical system.................................................................... 361
Measured parameters............................................................................................. 361
Construction..........................................................................................................362
Measurement cycle.................................................................................................362
Lambert-Beer's law................................................................................................ 363
Absorbance........................................................................................................... 363
Total absorbance....................................................................................................363
Continuous spectrum..............................................................................................364
Spectrum example................................................................................................. 364
Determining concentrations..................................................................................... 364
Matrix of constants.................................................................................................364
Calibration of the optical system..................................................................... 365
Calibration materials.............................................................................................. 365
Zero point............................................................................................................. 365
Cuvette path length................................................................................................365
Correcting for interferences............................................................................365
HbF versus HbA..................................................................................................... 365
Deviation of results................................................................................................ 366
Detecting HbF........................................................................................................366
Correcting for HbF..................................................................................................366
Repressing spectra................................................................................................. 366
Residual spectrum..................................................................................................366
Measurement and corrections......................................................................... 367
Calculation of the values of the oximetry parameters.................................................. 367
Calculation of bilirubin* values.................................................................................367
Restrictions........................................................................................................... 368
Corrections for ctHb............................................................................................... 369
Corrections for ctBil*.............................................................................................. 369
References............................................................................................................ 369
13. Specifications
Analyzer specifications.................................................................................. 371

Ranges of indication and reportable ranges................................................................371
Measurement precision within specified ranges...........................................................372
Product specifications............................................................................................. 376
Environmental specifications....................................................................................378
Power-supply cords................................................................................................ 380
Analytical sensitivity – ctBil*....................................................................................380
Consumables specifications................................................................................ 380
Solution Pack............................................................................................... 380
Intended use of the Solution Pack............................................................................ 380
Solution Pack specifications..................................................................................... 380
Sensor Cassette........................................................................................... 382
Intended use of the Sensor Cassette.........................................................................382
Sensor Cassette specifications................................................................................. 382
xvi
14. Graphical symbols
Explanation of graphical symbols/icons..................................................................... 383
15. Ordering information
Solution Packs - code numbers................................................................................ 385

Sensor Cassettes - code numbers.............................................................................385
Spare parts and accessories - code numbers..............................................................385
Quality control products - code numbers................................................................... 386
Recommended Radiometer sampling devices - code numbers.......................................387
Power-supply cords - code numbers......................................................................... 388
16. Legal information
Patents and trademarks................................................................................. 389

Patents................................................................................................................. 389
Trademarks........................................................................................................... 389
Legal notices................................................................................................ 389
System performance.............................................................................................. 389
Third-party software and trademarks........................................................................ 389
Warranties and disclaimer....................................................................................... 389
Confidentiality....................................................................................................... 390
Changes............................................................................................................... 390
End-user license agreement with Microsoft................................................................ 390
Index 393
xvii
xviii
Introduction 1
Intended use
The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that
quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in
heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.
The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physi-
cians and therapists.
It is intended for use in a laboratory environment, near patient or point-of-care setting.
These tests are only performed under a physician's order.
Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing
the risk of kernicterus in neonates.
In the table below the measured parameters are shown:

Parameter group Parameter
pH/blood gas: pH (acidity)
pCO2 (carbon dioxide tension)
pO2 (oxygen tension)
Oximetry: ctHb (total hemoglobin concentration)
sO2 (oxygen saturation)
FO2Hb (fraction of oxyhemoglobin in total hemoglobin)
FCOHb (fraction of carboxyhemoglobin in total hemoglobin)
FHHb (fraction of deoxyhemoglobin in total hemoglobin)
FMetHb (fraction of methemoglobin in total hemoglobin)
FHbF (fraction of fetal hemoglobin)
Electrolytes: cK+ (potassium ion concentration)
cNa+ (sodium ion concentration)
cCa2+ (calcium ion concentration)
cCl– (chloride ion concentration)
Metabolites: cGlu (D-glucose concentration)
cLac (L(+)-lactate concentration)
ctBil* (concentration of total neonatal bilirubin in plasma)
*Bilirubin can only be measured on neonatal samples. This parameter is only available
in the Neonate blood analysis 65 μL mode.
1
Chapter 1: Introduction ABL90 FLEX: Instructions for use
Limitations of use
About limitations of use
CAUTION – ctBil results

ctBil results are only valid for neonatal bilirubin analysis.
Note: Only analyze heparinized and electrolyte-balanced human whole blood samples
or dedicated quality control material. If you analyze other sample types, you risk
damage to the analyzer and incorrect results on subsequent samples.
No tests on animal blood have been done. Animal blood is different from human blood
and the composition of the blood can be different within the same species.
Related information
Interference tests, page 242
Measurement of FHbF
The uncertainty in FHbF measurements exceeds the level that is necessary to measure
normal HbF levels in the adult reference range (0-1 %). The analyzer can measure
FHbF hemoglobin in all types of sample, but the analyzer must be set up to apply an
HbF correction to the results.
Related information
To enable HbF corrections, page 171
Operator training requirements
Operators must have received hands-on training in the procedures and functions that
are relevant for their field of work and that are described in this Instructions for use.
Operators must have been trained in the procedures and functions until they can do
them successfully.
WARNING – Risk of incorrect medical treatment

Failure to select the correct measurement mode can cause incorrect results and incor-
rect medical treatment. Operators must be trained to do the patient sample analysis
correctly.
WARNING – Risk of delayed medical treatment

Failure to analyze patient samples correctly may require a new sample to be analyzed,
which can delay medical treatment. Operators must be trained to do the patient
sample analysis correctly.
WARNING – Risk of infection

Failure to analyze patient samples correctly can expose operators to potentially infec-
tious blood. Operators must be trained to do the patient sample analysis correctly.
About this document
This document tells you what the analyzer can do and how to use it. The analyzer has
a default set up that can be customized. Some topics in this document may therefore
not be relevant to your analyzer.
2
ABL90 FLEX: Instructions for use Chapter 1: Introduction
Documentation
Note: The documents in the table give instructions for the safe and proper operation of
the analyzer. Radiometer does not accept warranty claims or product liability if opera-
tors do not follow these instructions.
Document Description
Instructions for use How to install and set up the analyzer, instructions for daily use and refer-
ence information
Inserts Instructions and information about consumables supplied for use with the
analyzer
About hazards
A hazard symbol shows which instructions an operator must obey to prevent risk to
persons or equipment. There are 2 types of hazard.
Hazard type Hazard Risk

symbol
WARNING Death or injury to persons
CAUTION Equipment damage
General warning and cautions

Only let authorized personnel collect and work with blood samples. Make sure to wear
gloves.
WARNING – Risk of electric shock
Make sure the analyzer is a minimum of 1.5 m from patient beds.
Dispose and handle all used sampling devices, quality control (QC) ampoules, Solution
Packs, Sensor Cassettes, Inlet Probes, Inlet Gasket Holders, Inlet Connector Gaskets
and Inlet Modules as biohazardous waste [1]. Follow your local regulations.
Reference
1. Clinical laboratory waste management. CLSI/NCCLS document GP5-A2, Clinical

Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Penn-
sylvania 19087-1898 USA.
3
Chapter 1: Introduction ABL90 FLEX: Instructions for use
4
Getting to know the analyzer 2
Overview of the analyzer
Front view
2
3
5
4
6
1 Touch screen 5 Inlet Gasket Holder
2 Barcode reader 6 Inlet handle
3 Sample mixer (for safePICO 7 Solution Pack

samplers)
4 Compartment for the Sensor 8 Battery indicator light

Cassette
5
Chapter 2: Getting to know the analyzer ABL90 FLEX: Instructions for use
Side and back view
1
3
2 7
4 8
5 9
10
6
11
12
13
14
15
16
1 Handle 9 Network cable port
2 Thermal printer 10 USB ports
3 USB port 11 Ventilator grid
4 Mouse port 12 Latch for manual release of a Solu-

tion Pack
5 Standby button 13 Power switch ON (|) and OFF (O)
6 External keyboard port 14 Mains power fuse
7 External monitor port 15 Mains power socket
8 COM port 16 Serial number
Consumables
Consumables are parts of the analyzer. The consumables have to be replaced at

different times. With the exception of the printer paper, the analyzer tells you when
consumables must be replaced.
Consumables Description
Sensor Cassette Contains sensors for the tests (except for the oximetry and bilir-
ubin tests)
6
ABL90 FLEX: Instructions for use Chapter 2: Getting to know the analyzer
Consumables Description
Solution Pack Contains pouches with QC and calibration material, rinse solution,
a gas mixture and closed containers to hold liquid and clot waste
Inlet Gasket Holder Holds the inlet gasket (1). This is where you put your sampling
device for sample aspiration.
Printer paper Paper for the thermal printer
To see details about installed consumables

1. Tap Menu > Analyzer status > Consumables.
An overview is shown.
2. Choose an option and follow the steps for it.
Option Steps
To see more data about the Solution Pack Tap Status > Solution Pack
To see more data about the Sensor Cassette Tap Status > Sensor Cassette
Is the analyzer ready for use?
Three important conditions
The analyzer is ready for use when three conditions are present.
1. Make sure that the analyzer is Ready.

2. The color of the tab of the parameters you want to get a result for is green or
yellow.
3. The color of the traffic light in the Analyzer status button is green or yellow.
7
Parameter tab colors
Parameter Indication
tab color
Green You will get a result for the parameter
Yellow with one A QC or calibration error was found for the parameter, but you will get a result
line crossing
Red with two No result will be reported for the parameter.

lines crossing
The conditions that may cause a parameter tab to be red are shown below.
• An operator has locked the parameter in the Parameter setup screen
• An operator has locked the analyzer (all parameter tabs will change to red)
• Parameter repression was enabled for the parameter and a QC and/or cali-
bration error is present
• Ampoule-based QC measurements are pending. The analyzer was set up to
lock after a Solution Pack and/or Sensor Cassette replacement until the QC
measurements are completed.
To access the Analyzer status screen

1. Tap Menu > Analyzer status or, if available on the screen, just the Analyzer
status button.
8
The Analyzer status screen
1 Analyzer status button – the 4 Sensor Cassette icon – the number

color of the traffic light on the adjacent to the icon shows the
button shows the overall status of number of tests that are left.
the analyzer.
2 Recommended action – if there 5 Solution Pack icon – the number

are any recommended actions, adjacent to the icon shows the
they are shown here when the number of activities that are left.
Analyzer status screen is opened.
3 Five buttons – the color of the

traffic lights adjacent to each
button shows the overall status of
various activities within the
analyzer. The buttons give access
to details and activities.
Analyzer status - Traffic light colors
Traffic light Indication Consequences

color
Green No condition exists that requires action. All operations are possible
Yellow One or more messages indicate a condition All operations are possible
that requires action, but not immediate
action.
Red One or more messages indicate a condition Only actions that are necessary
that requires immediate action. to remove the reported condi-
tions can be done.
Messages
The analyzer shows different types of message.
9
Message type Where messages are shown
Status In the Analyzer status screens
Feedback In the space above the parameter bar.

Note: Feedback messages tell operators something about an action that they
have just done or about measurements and calibrations in progress. Feedback
messages are shown for a short period of time.
Pop-up In pop-up windows
Result In result message screens
Activity In the Activity log screen
10
To find and troubleshoot messages in the Analyzer status screen
Prerequisite: The traffic light in the Analyzer status button is yellow or red.
1. Tap Menu > Analyzer status.

2. Tap the button adjacent to a yellow or red traffic light.
Option Steps
To troubleshoot a Follow the instructions on the screen

Recommended
action
To troubleshoot To troubleshoot errors in the Built-in QC and

Quality control Ampoule-based QC fields:
messages a) Select the quality control measurement marked by a ,
or symbol.
b) Tap the Result button.
c) Tap the Messages button.
d) Select the message.
e) Tap the Troubleshoot button.
f) Follow the instructions on the screen.
To troubleshoot messages in the QC Messages field:
a) Select the message.
b) Tap the Troubleshoot button.
c) Follow the instructions on the screen.
To troubleshoot To troubleshoot calibrations marked by a , or

Calibrations
symbol.
messages
a) Select the marked calibration.
To troubleshoot messages in the Message field:
To troubleshoot a) Select the message.

Consumables or b) Tap the Troubleshoot button.
System
messages c) Follow the instructions on the screen.
Related information
About guided troubleshooting, page 93
Is the analyzer operating on battery power?
If a battery is installed in the analyzer, the battery indicator light will be on and a
symbol in the lower right corner of the screen shows which power supply is in use.
11
Note: The analyzer can operate on battery power for a limited period of time. The age
and charge level of the battery and the number of activities that are done limit this
period.
Symbol Battery indicator Indication
Yellow light that Only battery power is in use

blinks slowly
Yellow light that Only battery power is in use.

blinks fast
The analyzer must be connected to the mains power supply to
prevent analyzer shutdown.
Note: The color of the battery in the symbol changes to red

when the level falls below 14 %. The analyzer shuts down when
the level falls below 11 %.
Green light Only the mains power supply is in use
Green light that Only the mains power supply is in use. It supplies power to the
blinks slowly analyzer and recharges the battery at the same time.
Note: The number indicates the charge level of the battery.
Common tasks
To log on
Dependent on how your analyzer is set up, you may have to log on to the analyzer to
get access to menus or buttons.
If it is necessary to log on to the analyzer, this is how to do it.
Note: It is not necessary to log on to an analyzer that is set up for anonymous use.
1. Tap Menu > Log on.

2. Enter or scan data into the fields.
Note: If that is not possible, tap the Extended logon or the Logon BC button
and enter or scan data into the fields.
To scan a barcode
1. Hold the barcode parallel to the barcode reader and no more than 7 cm from it.
12
To enter text
1. Tap where you want to enter text.
Option Steps
To use the keyboard on the screen a) Tap the button.

b) Enter the text.
c) Tap the button.
To use an external keyboard a) Enter the text.

b) Press the Enter key.
To select/deselect a check button

Option Steps
To select a check button Tap the check button.
To deselect a check button Tap the check button.
To save changes
Option Steps
To save changes and go to the previous Tap the Back button.

screen
To save changes and close the screen Tap the Close button.
13
Menu
Menu structure
Menu
Log off
Calibration programs Calibration

tHb calibration
Start programs
Rinse
Auxiliary programs Liquid sensor adjust
Pump calibration
Tubing refill
Setup (See Related information)
WDC report
Backup all data
Restore all data
Export data logs
Disk functions
Import / Export archives
Save setup
Utilities
Load setup
Sample counter Restore default setup
Temporary shutdown
Long term shutdown
RADIANCE browser
Service
Patient results log
Patient profiles log
Quality control log
Data logs Calibration log
Activity log
Replacement log
Patient results archive
Archived data logs Quality control archive
Calibration archive
Activity archive
Analyzer status
My results
Latest result
Related information
Setup menu structure, page 143
14
Data logs
About data logs
Data logs are where patient data and results of measurements and activities are saved.
Overview of data logs
Data logs Content
Patient results log • Results of patient sample analyses

• Results of calibration verification measurements
Patient profiles log Data that helps to identify patients whose blood has been analyzed
Calibration log Results of calibrations
Quality control log Results of QC measurements
Activity log Activities done on or by the analyzer
Replacement log Record of replacement activities
Archived data logs The oldest results/activities from the data logs.
Note: Automatic archiving must be set up.
To access data logs

1. Tap Menu > Data logs.
2. Tap the data log you want.
15
16
Patient sample analysis 3
General warnings and cautions

gloves.


Make sure you do not prick or scratch yourself on the Inlet Probe.
Anticoagulants
Most Radiometer sampling devices contain dry, electrolyte-balance heparin. In general,

this type of heparin gives good results, because it minimizes the bias on cNa+, cK+,
cCa2+ results.
Different types of anticoagulant may change the concentration of some parameters and
give false patient results.
Anticoagulant Possible effect on patient results
Heparin in liquid form Biased results on all parameters
Anticoagulants with sodium cations (Na+) Falsely high cNa+ results
Anticoagulants with sodium and potassium False cNa+ and cK+ results
cations (Na+ and K+)
Anticoagulants with Lithium/Zinc heparin False cCa2+ results
Anticoagulants with ammonium heparin False cCl– results
Disodium oxalate with sodium fluoride Falsely high cNa+, falsely low cCa2+ and false cGlu
and cLac results
Trisodium citrate False cNa+, cK+, cCa2+, pH, cGlu and cLac results
EDTA • False pH, pCO2, cNa+, cK+ and cCa2+ results

• False cCa2+ results in subsequent patient
samples
WARNING – Risk of incorrect results

Do not use EDTA as an anticoagulant, as it will cause incorrect pH, pCO 2, cNa+, cK+
and cCa2+ results and have an effect on subsequent cCa2+ measurements.
CAUTION – Risk of equipment damage

Do not use EDTA as anticoagulant as it will decrease the lifetime of the calcium sensor.
17
Chapter 3: Patient sample analysis ABL90 FLEX: Instructions for use
Good results come from good samples
What is a good sample?
Characteristics of a good Why are the characteristics important?

sample (in sequential order)
A recommended sampler is used To prevent incorrect results
The sample is clearly and To prevent a patient-sample mix-up

uniquely identified
The sample is collected from a To prevent incorrect results

suitable site
A sufficient sample volume is If there is no sufficient sample volume, the sample is lost
collected
Air bubbles are removed immedi- To prevent incorrect results

ately after collection
The sample is not exposed to To prevent incorrect ctBil results.

artificial light or sunlight
Bilirubin can only be measured on neonatal samples. This
parameter is only available in the Neonate blood analysis 65
μL mode.
The sample is gently mixed To prevent clots in the analyzer.

immediately after air bubbles
have been removed If there are clots in the analyzer, the analyzer cannot
analyze samples.
The sample is not shaken To prevent hemolysis of the sample.
Hemolysis can cause bias on electrolytes, especially cK+ and

Urea.
The sample is gently mixed again To have a homogeneous sample for the patient sample anal-
just before it is analyzed ysis.
Inhomogeneous samples may cause incorrect results.
The sample is analyzed immedi- To prevent that the sample gets too old.
ately after mixing
Note: For the best results, good samples must be analyzed
immediately. When this is not possible, samples must be
stored correctly, gently mixed immediately before analysis
and analyzed within the time period given in the storage
recommendations.
Note: The list includes most, but not all the characteristics of a good sample.
To get a good sample
Prerequisite: A recommended sampler is used.
Good results come from good samples [2,3,4]. Here are five points to remember.
1. Label the sample.

Use more than one patient identifier. For example, patient ID and sampler ID.
2. Collect the sample from a suitable site.
18
ABL90 FLEX: Instructions for use Chapter 3: Patient sample analysis
3. WARNING – Risk of incorrect results

Remove any air bubbles to prevent incorrect results.
Gently mix the sample immediately after air bubbles have been removed to
prevent clots.
To mix the sample, follow your local standard operating procedure and the instruc-
tions for use for the sampling device.
5. Analyze the sample immediately after mixing.
Note: When this is not possible, store the sample correctly, gently mix it just
before analysis and analyze it within the time period given in the storage recom-
mendations.
To mix a sample on the analyzer
Pre-requisite: A safePICO syringe with a safeTIPCAP
Note: If the sample is in a safePICO syringe with a safeTIPCAP cap, do not remove the
safeTIPCAP cap.
1. Put the syringe in the sample mixer.

2. Wait until the light starts blinking.
3. Remove the syringe.
Storage recommendations
These types of blood samples must be analyzed immediately after they are collected
[5,6]:
• Samples with increased leukocyte or platelet counts

• Samples with an atypical metabolism
• Fetal scalp samples
• Fast-clotting samples
• Samples with high pO2 values should be analyzed within 5 minutes after they are
collected [7].
WARNING – Risk of biased results especially pO2 results
Interpret with caution the results for samples in capillary tubes as the aerobic
sampling technique may cause bias.
Samples that cannot be analyzed immediately after they are collected must be handled
and stored correctly before they are analyzed [3,8]. The table provides an overview.
Sampling Type Handling and storage temperatures Analyze within

device this time
period
Syringe Plastic Keep at room temperature <30 minutes
[2,9,10,11,12,13]
Syringe Glass Keep at room temperature [2,3] <30 minutes
Keep in water at 0-4 °C. <60 minutes
Note: Do not keep the sample on ice as it can

cause hemolysis** [7,11,12,13].
Capillary tube Plastic* Keep at room temperature <10 minutes
Capillary tube Glass Keep at room temperature <10 minutes
19
Sampling Type Handling and storage temperatures Analyze within

device this time
period
Capillary tube Glass Keep the sample horizontal at 0-4 °C. <30 minutes
Note: Do not keep the sample on ice as it can

cause hemolysis** [7,11,12,13].
* Samples in safeCLINITUBES capillary tubes deteriorates with increased storage time

(greater variability of gasses and of tHb measurements).
** Hemolysis can cause bias on electrolytes, especially cK+.
Pre-registration of samples
About sample pre-registration
Sample pre-registration lets operators make sure that the patient data shown on the
screen belongs to the patient whose sample is to be analyzed. This reduces the risk of
patient/sample mix-up.
Note: The analyzer must be set up for sample pre-registration.
Related information
To set up sample pre-registration, page 162
To pre-register a sample
Prerequisites:
• The analyzer is set up for sample pre-registration

• A barcode that identifies the patient and/or the blood sample
1. Scan the barcode.

2. Make sure the data that is shown on the screen belongs to the patient whose
sample you want to analyze.
Option Steps
If the data is correct a) Analyze the sample.
If the data is not correct a) Tap the Cancel button.
Related information
To analyze a sample from a syringe, page 21
To analyze a sample from a capillary tube, page 22
To analyze a sample from a test tube, page 24
Analyzing patient samples
General information for obtaining successful patient sample analyses
The analyzer will guide you through the different steps of the patient sample analysis
process. Depending on the setup, the process will vary. Always look at the screen and
follow the instructions on the screen.
Depending on the setup:
20
• You may be able to select measurement mode during sample analysis. If so, you
must select a measurement mode, or the analyzer will automatically select the
measurement mode set up as default in the setup.
• In the Patient identification screen, it is mandatory to enter data in fields with
this icon:
The sample will be analyzed, but the results will not be available until data is
entered.
• In the Patient identification screen, it is possible to change the report layout
during sample analysis.
During patient sample analysis, make sure that the Inlet Probe does not touch the
plunger of or the fiber disk in the syringe as this may cause the sample to be aspirated
incorrectly.
If there is <1.1 mL in a PICO50 sampler or <0.7 mL in a PICO70/safePICO70 sampler,

you must be careful with this.
In order not to bend the Inlet Probe, hold the sampling device still during sample anal-
ysis. If the Inlet Probe is bent, do not use the analyzer for sample analysis.
To analyze a sample from a syringe
Prerequisites:
• A good sample (no air bubbles, no exposure to air, and no clots)

• Make sure that the analyzer is Ready
• An Inlet Clip is installed if a non-Radiometer syringe is used. Contact your
Radiometer representative for more information.
Note: If the sample is in a safePICO syringe with a safeTIPCAP cap, do not remove the
safeTIPCAP cap during sample analysis.
Note: Once the inlet is opened, you only have a short time to complete the actions
necessary.

Gently mix the sample to make sure that it is homogeneous.
2. Hold the syringe by its barrel.
3. Lift the inlet handle to the syringe position.
4. If measurement mode can be selected, select measurement mode.

WARNING – Risk of missing results
Make sure that you select the Neonate blood analysis mode to get neonatal ctBil
results on neonatal samples*
Note: If you selected the wrong mode, tap the Reselect button and select the
correct mode.
Note: If the Other modes button is available, tap it to get access to more modes.
5. Follow the instructions on the screen.
21
6. Place and hold the tip of the syringe in the center of the Inlet Gasket.
7. WARNING – Risk of incorrect tHb results
Push the syringe into the analyzer as far as it will go and hold it there.
8. Hold the syringe in the pushed-in position until the analyzer tells you to remove it.
9. When the analyzer tells you to, remove the syringe.

10. Close the inlet.
11. If necessary, select a different report layout as follows:
a) Tap the current Report layout shown on the screen.
b) Select a new layout from the list.
c) Tap the Select button.
12. Enter the necessary data in the Patient identification screen.
Note: It is mandatory to enter data in fields with this icon:
13. If the Patient result screen opens before you have entered the necessary data,
tap the ID button.
Related information
To pre-register a sample, page 20
To get a good sample, page 18
To analyze a sample from a capillary tube
Prerequisites:
To prevent clots, it is recommended that you use an ABL90 FLEX Clot Catcher.
22
necessary.

2. Move the mixing wire to the end opposite to that from which the sample is to be
aspirated.
Note: If petroleum jelly, such as Vaseline, is used at the puncture area, introduce
the capillary sample into the analyzer from the end without petroleum jelly.
3. Remove the end caps of the capillary tube.
4. Put the Clot Catcher on the end opposite to that with the mixing wire.
5. Hold the capillary tube and lift the inlet handle to the capillary tube position.

correct mode.
8. Place and hold the end with the Clot Catcher in the center of the Inlet Gasket.
Note: If you turn the capillary tube slightly when you place it in the center, it may
be easier to put it in the right place.
9. Carefully push the capillary tube into the analyzer as far as it will go and hold it
there.
23
10. Hold the capillary tube in the pushed-in position until the analyzer tells you to
remove it.
11. When the analyzer tells you to, remove the capillary tube.
tap the ID button.
Related information
To analyze a sample from a test tube
Prerequisites:
• No Inlet Clip is installed on the Inlet Gasket Holder
necessary.

2. Uncap the test tube.
3. Hold the test tube and lift the inlet handle to the syringe position.
24

correct mode.
6. Place and hold the lip of the test tube against the collar of the Inlet Gasket.
7. Push the test tube into the analyzer as far as it will go and hold it there.
Note: Make sure that the probe extends into the sample and stays there during
sample aspiration.
8. Hold the test tube in the pushed-in position until the analyzer tells you to remove
it.
9. When the analyzer tells you to, remove the test tube.
tap the ID button.
Related information
25
To get calculated values for FShunt and ctO2(a-v̄)
Prerequisites:
• A patient report layout for FShunt and ctO2(a-v̄) has been created
• A mixed-venous blood sample and an arterial blood sample, collected directly after
each other from the patient
1. Analyze the mixed-venous blood sample. Use the report layout created for FShunt
and ctO2(a-v̄).
2. Enter data in the Patient identification screen.
Note: If the Patient identification screen closes before you have entered the
necessary data, tap the ID button to get back to the Patient identification
screen.
3. Note the values for these parameters. You need them for steps 6 to 9 inclusive:
• pO2(v)̄
• sO2(v̄)
• FO2(I)
• RQ
• T
4. Analyze the arterial sample. Use the report layout created for FShunt and
ctO2(a-v̄).
5. Select “Arterial” for Sample type.
6. Enter the values for pO2(v)̄ and sO2(v)̄ that were noted in step 3.
7. If the FO2(I) value is not equal to the default value of 0.21, enter the value you
noted in step 3.
8. If the RQ value is not equal to the default value of 0.86, enter the value you noted
in step 3.
9. If the T value is not equal to the default value of 37 °C, enter the value you noted
in step 3.
10. Enter other data in the Patient identification screen.
Note: If the Patient identification screen closes before you have entered the
necessary data, tap the ID button to get back to the Patient identification
screen.
Note: If no value is entered for pO2(v)̄ , sO2(v̄), FO2(I), RQ or T, the FShunt value
will be estimated.
Note: If no value is entered for pO2(v)̄ and sO2(v̄), a default value will be used for
ctO2(a-v̄).
Related information
To create a patient report layout, page 163
Entering and editing data in the Patient identification

screen
The Patient identification screen
The content of the Patient identification screen shown below shows the items
included in the -R- Default report layout. Other layouts can be created.
26
To change the report layout in the Patient identification screen
When you change the report layout, data fields in the Patient identificatlon screen
can change.
1. Tap the current Report layout.

2. Select a new layout.
3. Tap the Select button.
To request patient data automatically when connected to a LIS/HIS

system
Prerequisites:
• The analyzer is connected to a LIS/HIS/data management system
• The analyzer is set up to enable automatic requests for patient data
1. In the Patient identification screen, enter data in the field that was set up to
enable data to be requested automatically.
Note: It will be one of these fields: Accession number or Patient ID or
Sampler ID.
Note: If no data is transmitted, tap the Request button.
To request patient data using Patient lookup
Prerequisites:
• The Patient report includes the Department (Pat.) field
• The analyzer is set up to enable patient lookup
1. In the Patient identification screen, enter data in the Department (Pat.) field.
2. Tap the Patient lookup button.
3. Select the patient from the list.
Based on the Patient ID of the patient you selected, data is requested and down-
loaded to the Patient identification screen.
27
To edit data in the Patient identification screen

1. Find the patient result.
2. Tap the ID button.
3. Edit the necessary data.
Patient results
To find a patient result

Option Steps
To find a result in the data a) Tap Menu > Data logs > Patient results
log log.
b) Select the measurement.
c) Tap the Result button.
To find a number of results in a) Filter the data from the Patient results log
the data log
To find the latest result a) Tap Menu > Latest result.
To find a result under My a) Tap Menu > My results.

results b) Select the measurement.
Symbols on patient results
Problems on patient results are marked with one or more of the symbols shown in the
table.
Symbol Description
An error occurred. A message attached to the result describes the error.
Result is above the reference range but below the upper critical limit
Result is below the reference range but above the lower critical limit
Result is above the upper critical limit but below the upper limit of the reportable
range
Result is below the lower critical limit but above the lower limit of the reportable
range
No result is shown because it is above the upper limit of the reportable range.
Note: The analyzer can be set up to show the result as greater than the value of
the upper limit of the reportable range. For example: All pH results above 7.850
(the upper limit of a pH reportable range) will be shown as >7.850.
28
Symbol Description
No result is shown because it is below the lower limit of the reportable range.
Note: The analyzer can be set up to show the result as less than the value of the
lower limit of the reportable range. For example, all pH results below 6.750 (the
lower limit of the pH reportable range) will be shown as <6.750.
..... No result could be calculated
(blank) No result is shown because it is outside the range of indication* of the analyzer.
* User-defined correction factors were used to calculate the result
c A subscript of the letter c shows that the value was calculated from measured
and/or keyed-in (input) values. Only shown on derived parameters.
e A subscript of the letter e shows that the value was estimated. Default values
were used to replace measured and/or keyed-in (input) values that were not
available. Only shown on derived parameters.
* The Range of indication is the range the analyzer is capable of measuring and
includes values outside the Reportable range. The performance of the analyzer outside
the Reportable range specified in the Specifications chapter has not been validated.
Only results within the Reportable range should be reported.
About ranges and critical limits
Measurement results are marked by symbols to show where they fall in relation to
reference ranges, critical limits and reportable ranges. The diagram illustrates these
relationships.
1 Reference range 4 Reportable range
2 Lower critical limit 5 Range of indication
3 Upper critical limit
The Range of indication is the range the analyzer is capable of measuring and includes
values outside the Reportable range. The performance of the analyzer outside the
Reportable range specified in the Specifications chapter has not been validated.
Status in the Patient results log
The Status column in the Patient results log screen shows the overall status of each
patient sample analysis.
29
Symbol Description
OK The sample analysis was successful
? An error was found on one or more parameter result.
Aborted The sample analysis was stopped by the analyzer because it found an error
To see messages on patient results
Prerequisite: There are messages on the patient result.
1. Tap Menu > Data logs > Patient results log.

2. Select the measurement.
3. Tap the Result button.
4. Tap the Messages button or tap the Log > Messages buttons.
To troubleshoot messages on results
Prerequisite: You can see the message you want to troubleshoot.
1. Select the message.

2. Tap the Troubleshoot button.
To see the acid-base chart for a result
Prerequisite: The sample type must be specified as “Arterial” and the results must
include pH and pCO2 values.

4. Tap the acid-base chart button.
Note: The chart must only be used as a guideline.
Reviewing and editing patient results
To filter data from the Patient results log

2. Tap the Filter button.
3. In the Criteria frame, choose an option and follow the steps for it.
Option Steps
To select a time period prior to Tap the number button for the number of
today's date days you want
To select a start and end date Enter data in the Start date: and End date:
fields
4. Select the next criterion. If necessary, enter or select a value for it.
30
5. If more criteria are necessary, tap the More button.

6. If necessary, do step 4 again.
7. Tap the Apply button.
To see trends in a patient's results
Prerequisite: You have filtered the patient's results from the Patient results log.
1. Tap the Trend button.

2. Select the parameters.
3. Tap the View trend button.
To see the audit trail on a patient result
Prerequisite: Changes were made to the patient result.
An audit trail shows the changes made to a patient result.

4. Tap the Log > Audit trail buttons.
Note: The Log button will only be available if changes were made to the patient
result.
To add a note to a patient result

4. Tap the Messages button.
5. Tap the Note button.
Option Steps
If a pop-up window is shown To use one of the listed notes:

• Select the note
• Tap the Enter button
To enter a new note:
• Tap the Edit Note button.
• Enter the note.
If no pop-up window is shown Enter a note.

7. Tap the Back > Close buttons.
To remove a parameter from a patient result
Prerequisite: The result is not approved or rejected.

3. Tap the Result > ID > Parameters buttons.
31
4. Deselect the check buttons for the parameter you want to remove.
5. Tap the Back > Back > Close buttons.
Note: The result of the parameter is removed from the Patient results screen
and from printed results.
To show a parameter in a patient result
Prerequisites:
• The parameter was removed from the patient result
• The patient result is not approved or rejected
This procedure allows you to see the parameter on the screen and in printed results.

3. Tap the Result > ID > Parameters buttons.
4. Select the check button for the parameter you want to see.
5. Tap the Back > Back > Close buttons.
Approval and rejection of patient results
Approval/rejection of patient results is not set up by default. If it is set up, it can be

used to filter patient results that are transmitted to a LIS/HIS system. Approved
results are transmitted, rejected results are not.
Note: An approved patient result does not indicate that the result can be used in a
clinical evaluation of the patient.
Approval can for example be used to make sure that necessary data was correctly
entered, for example, that the Sample type was “Venous”, not “Arterial” and the
patient temperature was 42 °C, not 38 °C.
Note: Approved/rejected results cannot be edited.
To approve a patient result

4. Tap the Approval > Approve buttons.
5. Tap the Accept button.
To reject a patient result

4. Tap the Approval > Reject buttons.
32
Critical limit notification
About Critical limit notification
In some countries physicians must be notified when a patient result lies outside the
critical limit.
When Critical limit notification is enabled, a notification procedure is necessary

before results with values outside the critical limit can be transmitted to external
systems and printed automatically. The results are pending until a notification proce-
dure is done. The results can be seen in Pending results log.
To enable Critical limit notification

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Tap Enable critical limit notification.
3. Tap the check button.
4. Tap the Close button.
Note: If a print of the result is needed, you can make a print from the Notifica-
tion screen. The printout will tell you that the notification is pending.
To use Critical limit notification

1. Choose an option and follow the steps.
Option Steps
If a pop-up window notifies you a) Go to step 2.

that the result has values that lie
outside critical limits.
If an exclamation mark is shown a) Tap Data logs > Pending results log.
on the Data logs button. b) Highlight a result.
Note: A pop-up window notifies you that the
result has values that lie outside critical limits.
2. Tap inside the message to close the pop-up window.

3. Tap Notification.
4. See the values that are outside critical limits.
Note: If it is not necessary to notify about the values, tap Not needed and go to
step 6.
5. Call the physician or person responsible for the treatment and notify them about
the values.
6. Fill in the data fields on the screen.
Pending results log
The Pending results log contains the following results:

• Results that someone needs to be notified about
• Results that need to be approved
• Results that need mandatory input
Results in the Pending results log are filtered from the Patient results log and
remain pending until they have been dealt with. If results are pending, an exclamation
mark is shown on the Data logs button.
33
To access the Pending results log

1. Tap Data logs > Pending results log.
Input fields for the Patient report layout
The following notification-related input fields can be added to the patient report layout:
• Notified whom
• Notified time
• Notified by
• Notification status
• Notification
Note: To include these items in a patient report layout, see Reviewing and editing
patient results.
References

2. CLSI. Procedures for the collection of arterial blood specimens; approved
standard - Fourth Edition. CLSI/NCCLS document H11-A4, Clinical Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2004.
3. CLSI. Blood gas preanalytical considerations: specimen collection, calibration and
controls; Approved guideline. CLSI/NCCLS document C27-A, Clinical Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087- 1898 USA, 1993.
4. CLSI. Procedures and devices for the collection of diagnostic capillary blood speci-
mens; approved standard - Fifth Edition. CLSI/NCCLS document H4-A5, Clinical
sylvania 19087-1898 USA, 2004.
5. Woolley A, Hickling K. Errors in measuring blood gases in the intensive care unit:
Effect of delay in estimation. J Crit Care 2003; 18: 31-37. 12. Blonshine S. To ice
or not to ice. AARC Times 2000: 37-39.
6. Nickelsen CN. Fetal capillary blood pH. www.bloodgas.org, 2002.
7. Burnett RW, Covington AK, Fogh-Andersen N et al. Approved IFCC recommenda-
tions on whole blood sampling, transport and storage for simultaneous determina-
tion of pH, blood gases and electrolytes. Eur J Clin Chem Clin Biochem 1995; 33:
247-53.
8. Skurup A. Storage recommendations for blood gas samples. Radiometer Publica-
tion bulletin no. 31-2006. Copenhagen: Radiometer Medical A/S. Code no.
918-686.
9. Mahoney JJ, Van Kessel A. Arterial blood gas analysis. Respir Care 1997: 249-79.
10. Smeenk F, Janssen J, Arends B, Harff G, Bosch J, Schönberger J, Postmus P.
Effects of four different methods of sampling arterial blood and storage time on
gas tensions and shunt calculation in the 100% oxygen test. Eur Respir J 1996;
10: 910-13.
11. Mahoney JJ, Harvey JA, Wong RJ, Kessel VLA. Changes in oxygen measurements
when whole blood is stored in iced plastic or glass syringes. Clin Chem 1991; 37:
1244-48.
12. Blonshine S. To ice or not to ice. AARC Times 2000: 37-39.
13. Liss P, Payne P. Stability of blood gases in ice and at room temperature. Chest
1993; 103: 1120-21.
34
Replacements and maintenance 4
General warnings and cautions

gloves.



Make sure that you wear gloves during replacement and maintenance procedures.
To order products for use with your analyzer

1. Find the code number for the product.
2. Contact your local Radiometer representative.
Related information
Solution Packs - code numbers, page 385
Sensor Cassettes - code numbers, page 385
Spare parts and accessories - code numbers, page 385
Quality control products - code numbers, page 386
Replacement intervals for consumables and Inlet Connector Gasket
The recommended replacement intervals shown in the table are only a guideline. They
are based on a default of 10 sample analyses per day. For analyzers with a higher
sample throughput, the number of Expected measurements per day can be
changed in the setup, so the analyzer can calculate the most probable replacement
date and send a message about it.
Consumables Default tests or Recommended replacement interval after

activities per day installation
Solution Pack 10 Maximum 30 days or when the number of activ-

ities is zero
Sensor Cassette 10 Maximum 30 days or when the number of tests

is zero
Inlet Gasket Holder 10 12 months
Inlet Connector Gasket 10 12 months
Related information
To set up replacement warnings, page 197
35
Chapter 4: Replacements and maintenance ABL90 FLEX: Instructions for use
Replacements
Solution Pack
To see the Solution Pack status

2. For more information, tap the Status > Solution Pack buttons.
To replace the Solution Pack
Prerequisite:
A new Solution Pack

2. Tap the Consumables > Replace > Solution Pack buttons.
3. Tap the Press to start video guidance button.
4. Lift the inlet handle to the capillary position.
5. Wait until the Solution Pack is released.

Note: If the Solution Pack is not released, you can release it manually.
6. Remove the Solution Pack and dispose of it as biohazardous waste.
36
ABL90 FLEX: Instructions for use Chapter 4: Replacements and maintenance
7. Lift the new Solution Pack out of its box as shown.
8. Pull the red pin out of the new Solution Pack.
9. Put the palms of your hands over the edges of the lid as shown.
10. Press down firmly and evenly with both hands until the tabs click into the 2 holes.
Note: For the Solution Pack to be activated correctly, both tabs must click in place.
11. Tap the Action Completed button.
37
12. Put your thumbs on the white part of the Solution Pack and push the Solution Pack
into its compartment until it clicks in place.
13. When the analyzer tells you to, close the inlet.
14. Enter necessary data.
15. Tap the OK button.
To release the Solution Pack manually
Note: Use this procedure to release the Solution Pack from its compartment if it is not
automatically released during a replacement or maintenance procedure.
1. Press the Solution Pack into the analyzer while you press down the latch on the
back of the analyzer.
2. Remove the Solution Pack.
Can a Solution Pack be used again?
A Solution Pack removed from one analyzer can be used on another if these 3 condi-
tions are met:
• the Solution Pack is installed before its Scheduled to replace: date
• the Solution Pack is installed before its Expiration date:
• the Solution Pack has some remaining activities
This data can be seen in the Solution Pack Status screen.

Related information
To see the Solution Pack status, page 36
38
Status logs
Status logs include all the data that tells something about the performance of a
consumable that has been removed from the analyzer. The data can be printed or
exported to a USB flash drive.
To print Solution Pack status logs

1. Tap Menu > Data logs > Replacement log.
2. Select the “Solution pack removed” activity.
3. Tap the Send status to printer button.
To export Solution Pack status logs
Prerequisites:
• A USB flash drive
1. Plug in the USB flash drive.

3. Select the “Solution pack removed” activity.
4. Tap the Export status logs button.
Sensor Cassette
To see the Sensor Cassette status

2. For more information, tap the Status > Sensor Cassette buttons.
To replace the Sensor Cassette
Prerequisite:
A new Sensor Cassette
Note: The analyzer has to condition a new Sensor Cassette after it is installed. This
process can take up to 4 hours.

2. Tap the Consumables > Replace > Sensor Cassette buttons.
3. Tap the Press to start video guidance button
4. Wait until the Sensor Cassette compartment opens.
39
5. Remove the Sensor Cassette and dispose of it as biohazardous waste.

7. Pull the foil off the new Sensor Cassette Pack, unscrew the lid and lift out the
Sensor Cassette.
9. Press the new Sensor Cassette in place.

Note: If you tap the Exit conditioning button, the more frequent calibrations
that normally follow in the 24 hours after a Sensor Cassette replacement will not
be done. This may have an effect on the accuracy and precision of patient results
in this period of time.
Related information
Can a Sensor Cassette be used again?, page 41
Calibration frequency after a Sensor Cassette replacement
Calibrations are done more frequently in the 24-hour period that follows a Sensor
Cassette replacement. This has an effect on the number of analyses that can be done
per hour during this time period.
Note: A calibration takes up to 2½ minutes.
Time period after a replacement Calibration frequency
0-4 hours In connection with every measurement
4-6 hours Every 15 minutes
6-8 hours Every 30 minutes
8-12 hours Every hour
40
Time period after a replacement Calibration frequency
12-24 hours Every 2 hours
Related information
Frequency of automatic calibrations, page 85
Can a Sensor Cassette be used again?
A Sensor Cassette removed from one analyzer can be used on the same or on another
ABL90 FLEX analyzer if these 6 conditions are met.
• The Sensor Cassette is kept right side up after its removal. This prevents damage to
the sensors.
• The Sensor Cassette is installed within 2 hours of its removal
• The Sensor Cassette is installed before its Scheduled to replace date
• The Sensor Cassette is installed before its Expiration date
• The Sensor Cassette has some remaining activities
• The Sensor Cassette was not removed from an analyzer during a long-term shut-
down procedure
This data can be seen in the Sensor Cassette Status screen.

Related information
To see the Sensor Cassette status, page 39
Status logs
Status logs include all the data that tells something about the performance of a
consumable that has been removed from the analyzer. The data can be printed or
exported to a USB flash drive.
To print Sensor Cassette status logs

2. Select the “Sensor Cassette removed” activity.
3. Tap the Send status to printer button.
To export Sensor Cassette status logs
Prerequisites:
1. Plug in the USB flash drive.

3. Select the “Sensor cassette removed” activity.
4. Tap the Export status logs button.
41
Thermal printer paper
To replace the thermal printer paper
Prerequisite:
A new roll of thermal printer paper

2. Tap the Consumables > Replace > Paper buttons.
3. Press the release button.
4. Open the cover and remove the used paper roll.

5. Put in the new paper roll. Make sure the paper unwinds from below.
6. Make sure some paper extends out of the printer.
7. Close the cover. The cover must click in place.
8. Tap the Replaced button.
Protection of printed data
Note: Do not expose data printed on the thermal printer paper of the analyzer to high
temperatures, high humidity, direct sunlight, water, alcoholic or organic solvents,
freshly-developed diazo copy sheets or materials that contain polyvinylchloride (PVC),
and do not scratch them. Keep the printed data in polyethylene, polypropylene or poly-
ester folders or boxes.
These precautions will help you to protect your printed data.
42
Inlet Gasket Holder
To replace the Inlet Gasket Holder
Prerequisite:
A new Inlet Gasket Holder

The used Inlet Gasket Holder has been in contact with blood and must be handled as
potentially infectious.

2. Tap the Other activities > Inlet check > Repl. Inlet Gasket Holder buttons.
4. Pull off the inlet cover.
5. Tap the Action completed button.

6. Lift the inlet handle to its highest position.
43
7. Pull out the Inlet Gasket Holder.

9. Insert the new Inlet Gasket Holder. Make sure that the Inlet Probe is in the center
of the gasket.
Note: Make sure the Inlet Gasket Holder clicks in place.

12. Put on the inlet cover.
Inlet Probe
To replace the Inlet Probe
Prerequisite:
A new Inlet Probe

The used Inlet Probe has been in contact with blood and must be handled as poten-
tially infectious.

2. Tap the Other activities > Inlet check > Repl．inlet probe buttons.
44

7. Hold the Inlet Module as shown, press your fingers together and pull to the right.
45
10. Lift up the Inlet Probe as far as it will go and pull it to the right to remove it.

12. Hold the new Inlet Probe in a vertical position and put it in place.
46
13. Lower the Inlet Probe.
14. Insert the Inlet Gasket Holder. Make sure that the Inlet Probe is in the center of
the gasket.

16. Hold the Inlet Module as shown, press your fingers together and push the end into
the inlet connector until it clicks in place.

47
Inlet Connector Gasket
To replace the Inlet Connector Gasket
Prerequisites:
A new Inlet Connector Gasket A pair of tweezers

The used Inlet Connector Gasket has been in contact with blood and must be handled
as potentially infectious.

2. Tap the Other activities > Inlet check > Repl．inlet connector gasket
buttons.

48

9. Pull out the Inlet Connector Gasket with a pair of tweezers.

11. Put tap water on the new Inlet Connector Gasket.
13. Push the new Inlet Connector Gasket in place as shown.
49

Inlet Module
To replace the Inlet Module
Prerequisite:
A new Inlet Module

The used Inlet Module has been in contact with blood and must be handled as poten-
tially infectious.

2. Tap the Other activities > Inlet check > Repl．inlet connector gasket
buttons.
Note: Only a new Inlet Module is necessary.
50

8. Tap the Action completed button four times.

9. When the analyzer tells you to, hold the new Inlet Module as shown, press your
fingers together and push the end into the inlet connector until it clicks in place.
51

Maintenance
Cleaning
Cleaning - when is it necessary?
The analyzer must always be kept clean. Exterior surfaces, the Inlet Gasket and other
parts of the analyzer must be cleaned when they are contaminated with blood and/or
other liquids.
To clean the inlet gasket
Prerequisite: A lint-free cloth


2. Tap the Other activities > Inlet check > Clean inlet gasket buttons.
5. Make sure the Inlet Probe is not bent. If it is bent, replace it.
6. Dampen a lint-free cloth with water.
8. Gently wipe the inlet gasket and the area around it until it is clean.
52
To clean the Inlet Module
Prerequisites:
• A mild detergent
• Demineralized water
• A lint-free cloth
Note: Do not put cleaning agents into the analyzer.


The used Inlet Gasket Holder has been in contact with blood and must be handled as
potentially infectious.

2. Tap the Other activities > Inlet check > Repl．inlet probe buttons.
Note: A new Inlet Probe is not necessary.

53

10. Lift up the Inlet Probe as far as it will go and pull it to the right to remove it.
11. Soak the Inlet Gasket Holder and Inlet Probe in the mild detergent solution.
Note: This step is not shown on the screen.
12. Flush the Inlet Gasket Holder and Inlet Probe with demineralized water.
Note: This step is not shown on the screen.
54
14. Hold the Inlet Probe in a vertical position and put it in place.
15. Lower the Inlet Probe.
16. Insert the Inlet Gasket Holder. Make sure that the Inlet Probe is in the center of
the gasket.

55

To clean the touch screen
Prerequisite: A lint-free cloth
1. Lightly dampen a lint-free cloth with tap water.

2. Put your finger on a part of the screen that is not active and hold it there.
3. Gently wipe the screen.
To clean the analyzer exterior
Prerequisites:
• A mild soap or detergent
Note: Radiometer has not tested whether cleaning wet wipes can be used for this
purpose.
Note: The Sensor Cassette compartment and the top surface of the Solution Pack
compartment must be cleaned by a Radiometer representatives.
1. Lightly dampen a lint-free cloth with soapy water or a mild detergent.

2. Wipe the analyzer exterior.
Disinfecting
Disinfection - when is it necessary?
Follow your local, state and federal guidelines.
56
To disinfect the touch screen
Prerequisites:
• The analyzer is clean
• A solution of 70 % iso-propyl alcohol (2-propanol) or 70 % ethanol
1. Lightly dampen a lint-free cloth with a recommended disinfection solution.

2. Put your finger on a part of the screen that is not active and hold it there.
3. Gently wipe the screen.
To disinfect the analyzer exterior
Prerequisites:
• The analyzer is clean
• A solution of 70 % iso-propyl alcohol (2-propanol), 70 % ethanol or 5 % sodium
hypochlorite
Note: Radiometer has tested that these solutions can be used once a week for 10
years.
Note: Radiometer has not tested whether disinfection wet wipes can be used for this
purpose.
Note: The Sensor Cassette compartment and the top surface of the Solution Pack
compartment must be disinfected by a Radiometer representatives.
1. Lightly dampen a lint-free cloth with a recommended disinfection solution.

2. Wipe the analyzer exterior.
To disinfect the fluid transport system

1. Do the long-term shutdown procedure.
Battery
To recharge the analyzer battery

1. Connect the analyzer to the mains power supply.
To install and service the battery

57
Disposal
To dispose of the analyzer
Contact your local Radiometer representative for instructions.
Inlet Clip
Inlet Clip - when is it necessary to use one?
If a non-Radiometer syringe is used, it may be necessary to install an Inlet Clip.

Contact your Radiometer representative for more information.
To put an Inlet Clip on the Inlet Gasket Holder
Prerequisite:
An Inlet Clip
This procedure is only necessary if a non-Radiometer syringe is used. Contact your

Radiometer representative for more information.
58
Note: The Inlet Clip must be removed before ampoule-based QC measurements and
when samples are analyzed from sample tubes.
2. Put the open end of the Inlet Clip over the back of the Inlet Gasket Holder as
shown and pull it in place.
59
To remove the Inlet Clip from the Inlet Gasket Holder
Note: The Inlet Clip must be removed before ampoule-based QC measurements and
when samples are analyzed from sample tubes.
2. Pull off the Inlet Clip from the back of the Inlet Gasket Holder.
Connecting peripherals
To connect a USB external keyboard / mouse
Prerequisite: A USB external keyboard/mouse
1. Connect the external keyboard/mouse cable to the external keyboard/mouse port

of the analyzer.
Note: The analyzer will find the connection to the external keyboard/mouse imme-
diately.
To connect a non-USB (PS/2) external keyboard or mouse
Prerequisite: A non-USB (PS/2) external keyboard or mouse.
1. Do a temporary shutdown.
2. Connect the external keyboard/mouse cable to the external keyboard/mouse port
of the analyzer.
3. Restart the analyzer.
60
To connect an external barcode reader

To connect the analyzer to a network
Prerequisite: RJ45 connector.
1. Connect the network cable to the network connector and the network cable port of
the analyzer.
Note: If the analyzer is set up for connection to a LIS/HIS or AQURE/RADIANCE
system, the analyzer will find the network connection immediately.
Reference

61
62
Quality control 5
Overview of quality control management
Quality control management is important as it evaluates the performance of the

analyzer to make sure that the patient results are accurate and precise.
The analyzer manages quality control automatically, but if local, federal or state regula-
tions require additional quality control procedures, operators can do them.
To find the status of QC measurements

2. Tap the Quality control button.
Note: A symbol in the Solution column shows the status of a QC measurement.
Symbols that show the status of QCs
Symbol Indication
The QC measurement was completed successfully
An error was found on one or more QC result
A scheduled QC measurement is pending. The last QC was completed successfully.
A scheduled QC measurement is pending. The last QC was not completed successfully.
Automatic quality control management

About automatic quality control management
Automatic quality control management (AQM) is the name given to quality control
procedures that the analyzer is programmed to do automatically.
Name of the proce- Description

dure
System checks Automatic test sequences done with each measurement and at other
times to make sure that all parts of the analyzer operate within specifi-
cations.
63
Chapter 5: Quality control ABL90 FLEX: Instructions for use
Name of the proce- Description

dure
Built-in QC These are liquid QC measurements that are automatically done by the
analyzer.
The 3 QC solutions in the Solution Pack are used for these measure-
ments.
Apply statistical rules Helps operators to find errors, shifts, and trends. Symbols on results
to QC results. show when rules are violated.
For example: Westgard Rules and RiLiBÄK rules (used in Germany).
Note: The analyzer must be set up to do this.
Apply corrective action The default corrective action for QC errors:

for QC errors • The color of the traffic light adjacent to the Quality control button
in the Analyzer status screen changes to yellow
• The parameter tab changes to yellow
• The ? symbol will be shown on the parameter in patient results
Note: The default settings can be changed.
Repress a parameter if Note: The analyzer must be set up to do this.

there are any problems
• Patient results will not include results for parameters with QC errors
• The parameter tab changes to red
Lock the analyzer until Note: The analyzer must be set up to do this.
requested
ampoule-based QC
measurements are Note: Patient samples cannot be analyzed while the analyzer is locked.
done after a Solution
Pack and/or Sensor
Cassette replacement
Related information
To set up and enable Westgard Rules, page 188
To add a new RiLiBÄK rule, page 189
To repress a parameter, page 170
To set up corrective action for errors in QC results, page 184
To request ampoule-based QC measurements after replacements, page 184
About system checks
Automatic test sequences done with each measurement and at other times to make
sure that all parts of the analyzer operate within specifications.
The analyzer automatically takes action to correct a problem it finds. If the action fails,
a message is shown and the analyzer goes into the Operator Action Needed, Trou-
bleshooting needed or Intervention Required mode. In these modes operators are
given instructions about what to do.
Results of failed system checks are recorded in the Activity log.
Overview of automatic quality management
Here is an overview of the default schedule for system checks, QC and calibration
measurements that the analyzer does to make sure that patient results are accurate,
precise and reliable.
64
ABL90 FLEX: Instructions for use Chapter 5: Quality control
Start of the system-check cycle
System checks
Built-in QC measurements
Sensitivity calibration of pCO2, cGlu, cLac and status calibration of the oximetry parameters
Sensitivity calibration of pH and the electrolytes (cK+, cNa+,cCa2+, cCl–)
Sensitivity calibration of pO2
A status calibration of all parameters (except the oximetry parameters) is done before
every patient, QC and sensitivity calibration measurement.
Related information
Details about calibration frequency, page 175
Built-in QC
About built-in QC measurements
The analyzer uses the three levels of QC solution contained in the Solution Pack to do
built-in QC measurements. These QC solutions are automatically registered in slots A,
B and C when a Solution Pack is installed.
Note: The solution in slot A is S9030, the solution in slot B is S9040 and the solution in
slot C is S9050.
Built-in QC measurement frequency
A built-in QC measurement is scheduled by default to be done every 8 hours. One

measurement a day is done with each QC solution. Built-in QC measurements are also
scheduled by default to be done in connection with these activities:
65
• Replacement of the Solution Pack

• Replacement of the Sensor Cassette
• Startup
You can edit the schedule for built-in QC measurements.
To request an unscheduled built-in QC measurement
Prerequisite: Make sure that the analyzer is Ready.
1. Tap Menu > Analyzer status > Quality control.

2. Select a QC solution in the Built-in QC field.
3. Tap the Start QC button.
The result of the QC measurement is saved in the Quality control log.
Built-in QC results
Status of built-in QC measurements
The symbols in the Solution column of the Quality control part of the Analyzer
status screen shows the overall status of each QC measurement.
Symbol Description
The QC measurement was successful
An error was found on one or more parameter result.
To find a built-in QC result

Option Steps
To find a result in the a) Tap Menu > Data logs > Quality control log.
data log b) Select the measurement.
Note: Built-in QC measurements are done with solu-
tions in slots A, B and C.
To find a number of a) Filter the data from the Quality control log.
results in the data log
To find the latest a) Tap Menu > Analyzer status > Quality control.
result b) In the Built-in QC field, select the measurement.
Related information
To filter data from the Quality control log, page 81
Symbols on built-in QC results
Problems on built-in QC results are marked with one or more of the symbols shown in
the table.
66
Symbol Description
An error was found. A message attached to the result describes the error.
The result is outside the control range, but inside the statistical range. Results inside
the statistical range are included in statistics.
The result is outside the statistical range. The result is not included in statistics
The result is outside the range of indication*. The result is not included in statistics
..... The result could not be calculated. When possible, an interpretation of the message is
attached.
* Operator-defined slope/offset corrections were used to calculate the result
W The result violates a Westgard rule
R The result violates a RiliBÄK rule
To see messages on built-in QC results

1. Tap Menu > Data logs > Quality control log.
Note: QC solutions used for built-in QC measurements are automatically regis-
tered in slots A, B and C.
To troubleshoot messages on built-in QC results

Quality control management done by

operators
Quality control management that can be done by operators
The analyzer manages quality control automatically, but if local, federal or state regula-
tions require additional quality control (QC) procedures, they can be done. These
procedures are called ampoule-based QC measurements.
67
QC procedures Description
Ampoule-based QC measure- Manual QC measurements done with QC ampoules

ments
Note: If local, federal or state regulations require that
analyzer-specific control ranges be established for the QC solu-
tions used for ampoule-based QC measurements, it can be
done.
Ampoule-based QC measure- The analyzer is locked until requested ampoule-based QC

ments after Solution Pack measurements are done.
and/or Sensor Cassette
replacements Note: The analyzer must be set up to do this.
Calibration verification meas- Measurements that let you verify the calibration and reportable
urements (for example in the range of measured parameters
USA).
Note: This procedure requires control material to be analyzed
as patient samples.
Related information
To do an ampoule-based QC measurement, page 71
About calibration verification, page 74
To request ampoule-based QC measurements after replacements, page 184
Ampoule-based QC measurements
QC solutions for ampoule-based measurements
Radiometer recommends that Radiometer QUALICHECK5+ solutions are used for

ampoule-based QC measurements. Four levels of QUALICHECK5+ solutions are avail-
able.
Note: If non-Radiometer QC solutions are used, Radiometer cannot guarantee accu-
rate, valid QC results.
How to get good ampoule-based QC measurement results
To get good ampoule-based QC measurement results, follow the listed advice.
• For Radiometer solutions only:

◦ Check that there are no calibration errors before you do an ampoule-based QC
measurement.
◦ Keep the QC solution under the correct storage conditions. See the product
insert.
◦ Hold the ampoule between the thumb and first finger when you shake it.
◦ Shake the ampoule vigorously for 15 seconds before it is opened.
◦ Use the Radiometer QUALICHECK adapter to hold the ampoule during the QC
measurement.
◦ Use the prepared QC solution immediately after the ampoule is opened.
◦ Use the ampoule for one QC measurement only.
◦ Enter the correct ampoule temperature in the Quality control identification
screen during the QC measurement.
• For non-Radiometer QC solutions:
68
◦ Check that there are no calibration errors before you do an ampoule-based QC

measurement.
◦ Keep the QC solution under the correct storage conditions. See the product
insert.
◦ Prepare the QC solution for use correctly. Follow the manufacturer's instructions.
To prepare a Radiometer QC ampoule for use
Prerequisites:
A QUALICHECK5+ ampoule An Ampoule Opener A QUALICHECK Adapter
Note: The Radiometer QUALICHECK5+ box that contains the QC ampoules has been
stored at a constant temperature (18-32 °C) for 5 hours.
Note: If there are errors on calibration results, they will be shown on the
ampoule-based QC results.
1. Remove a QC ampoule from its box.

2. Put the lid back on the box.
The ampoules are sensitive to light.
3. Hold the ampoule between your thumb and first finger and shake it vigorously for
a minimum of 15 seconds.
4. Hold the ampoule neck-side up and tap the top until all the solution collects in the
lower part of the ampoule.
5. Put the ampoule in the Ampoule Opener.
69
6. Use your fingers to apply pressure in the directions shown, to break off the neck of
the ampoule.
7. Gently pull the ampoule out of the Ampoule Opener.

8. Put the QUALICHECK Adapter over the open end of the ampoule.
9. Do an ampoule-based QC measurement immediately.
Related information
70
To do an ampoule-based QC measurement
Prerequisites:
• The QC solution is registered for use on the analyzer
• The QC ampoule is prepared for use
Note: If there are errors on calibration results, they will be shown on the
Note: The insert control ranges of Radiometer QC solutions are determined at a refer-
ence temperature of 25 °C. It is therefore important to enter the correct ampoule
temperature during QC measurements so the analyzer can temperature correct QC
results.
If the correct temperature is not entered, this will have an effect on pH, pCO2 and pO2
results. At temperatures above 25 °C, pH results will be too high and pCO2 and pO2
will be too low. At temperatures below 25 °C, pH will be too low and pCO2 and pO2
results will be too high.
Note: Radiometer QC ampoules are for single use only.
1. Hold the QC adapter with the QC ampoule and lift the inlet handle to the syringe
position.
2. Tap the Ampoule - QC button.

3. Turn the QUALICHECK Adapter with the ampoule so the Radiometer logo faces
upwards.
4. Put the QUALICHECK Adapter with the ampoule over the inlet gasket.
5. Push the adapter with the ampoule into the analyzer as far as it will go and hold it
there.
71
6. Hold the adapter with the ampoule in the pushed-in position until the analyzer tells
you to remove it.
7. When the analyzer tells you to, remove the QUALICHECK adapter with the
ampoule.
8. Close the inlet.
9. Make sure the Solution: field is selected.
10. Make sure that there is only one lot of the QC solution.
Note: QC solutions are identified by a Solution name (for example S7730) and a
Lot number.
11. If there is only one lot, go to step 13.
12. If there is more than one lot, select the correct lot of QC solution.
13. Enter the ampoule temperature.
Note: It is important to enter the correct temperature. See the note above.
14. Enter other necessary data in the Quality control identification screen.
16. Remove the ampoule from the adapter and discard the ampoule as biohazardous
waste.
Related information
To register a Radiometer QC solution for ampoule-based QC measurements, page 178
To request an unscheduled calibration from the Analyzer status screen, page 87
To request an unscheduled calibration from the Analyzer status screen, page 87
To edit QC identification data
Note: You can only edit the Department, Operator and Note fields.

2. Select a measurement done with the QC solution you want to edit.
Note: QC solutions are identified by a Solution name (for example, S7730) and
Lot number.
4. Tap the QC ID button.
5. Edit the necessary data.
Ampoule-based QC results
Status of ampoule-based QC measurements
The symbols in the Solution column of the Quality control part of the Analyzer
status screen shows the overall status of each QC measurement.
72
Symbol Description
The QC measurement was successful
An error was found on one or more parameter result.
To find an ampoule-based QC result

2. Select the solution.
Symbols on ampoule-based QC results
Problems on ampoule-based QC results are marked with one or more of the symbols
shown in the table.
Symbol Description
An error was found. A message attached to the result describes the error.
The result is outside the control range, but inside the statistical range. Results inside
the statistical range are included in statistics.
The result is outside the statistical range. The result is not included in statistics.
The result is outside the range of indication*. The result is not included in statistics.
..... The result could not be calculated. When possible, an interpretation of the message is
attached.
* Operator-defined slope/offset corrections were used to calculate the result
W The result violates a Westgard rule
R The result violates a RiliBÄK rule
To see messages on ampoule-based QC results

2. Select the solution.
3. Tap Result button.
73

Calibration verification
About calibration verification
Some local, state or federal regulations require calibration verification to be done (for
example, in the USA). Calibration verification is a process that lets you verify the cali-
bration and reportable range of the parameters measured by the analyzer.
Calibration verification is a 3-stage process:
• Stage 1: Analyze as patient samples a minimum of three different levels of QC

solution.
Note: On the analyzer, these measurements are referred to as calibration verifica-
tion measurements.
• Stage 2: Use the calibration-verification measurement results to verify the calibra-
tion and reportable range of the measured parameters. Follow your local, state and
federal guidelines.
• Stage 3: If necessary, change the reportable range of parameters.
Related information
To set up reportable ranges, page 161
Frequency of calibration verification
Follow your local, state or federal regulations.
74
Stage 1 - Analyzing different levels of control solution
To prepare a Radiometer calibration-verification ampoule for use
Prerequisites:
A calibration-verification An Ampoule Opener A QUALICHECK Adapter

ampoule
Note: The Radiometer box that contains the QC ampoules for calibration verification
has been stored at a constant temperature (18-32 °C) for 5 hours.
Note: If there are errors on calibration results, they will be shown on the calibra-
tion-verification results.
1. Remove a calibration-verification ampoule from its box.

3. Hold the ampoule between your thumb and first finger and shake it for a minimum
of 15 seconds.
4. Hold the ampoule neck-side up and tap the top until all the solution collects in the
lower part of the ampoule.
6. Use your fingers to apply pressure in the directions shown, to break off the neck of
the ampoule.
7. Gently pull the ampoule out of the Ampoule Opener.
75
9. Do a calibration-verification measurement immediately.
Related information
To do a calibration-verification measurement
Prerequisites:
• A calibration-verification mode has been set up
• The calibration-verification control solution is prepared for use
Note: Radiometer calibration-verification ampoules are for single use only.
2. Tap the Cal．Verification button.

upwards.
4. Put the QUALICHECK Adapter with the ampoule over the inlet gasket.
there.
76
you to remove it.
7. When the analyzer tells you to, remove the adapter with the ampoule.
8. Close the inlet.
9. Enter enough information to identify the calibration-verification control solution in
the Patient ID field.
Note: Enter a maximum of 20 characters. If more are entered they will not be
sent to LIS/HIS and/or AQURE/RADIANCE systems.
10. If necessary, enter a note.
Note: Results are not temperature-corrected. If the ampoule temperature was not
25 °C, you must temperature-correct the results manually. Results are saved in
the Patient results log.
12. Remove the ampoule from the adapter and dispose of it as biohazardous waste.
Post-requisite: Do calibration-verification measurements with a minimum of 3 levels of

calibration-verification control solution.
Related information
To set up a calibration-verification mode, page 156
To temperature correct calibration-verification results based on Range+ QUALICHECK
measurements, page 78
Stage 2 - Using results to verify reportable ranges
To find a calibration-verification measurement result
Calibration-verification results are saved in the Patient result log. The results are
identified as “Cal．Verification” in the Sample type column.
Note: Results for pH, pCO2 and pO2 must be corrected if the temperature of the
ampoule during the measurement was above or below 25 °C.

Option Steps
fields
4. For Sample type, select “Cal．Verification”.
77

Note: The result must be temperature corrected.
Symbols on calibration-verification measurement results
Problems on calibration-verification results are marked with one or more of the

symbols shown in the table.
Symbol Description
An error occurred. A message attached to the result describes the error
The result is above the upper limit of the reportable range
The result is below the lower limit of the reportable range
..... No result could be calculated or the result is outside the range of indication* of the
analyzer
* Operator-defined correction factors were used to calculate the result
To temperature correct calibration-verification results based on

Range+ QUALICHECK measurements
ampoule during measurements was above or below 25 °C.
1. Find the temperature constant (A) in the table.
Radiometer calibration-verification control solutions (Range+ QUALICHECK prod-

ucts)
Parameter Temperature constants (A)
Level 1 Level 2
pH 0.0013 0.0026
pCO2 –0.0056 –0.0071
pO2 –0.0098 –0.0107
Note: It is not necessary to temperature correct the results for Range+

QUALICHECK solution level 3.
2. Use the equations in the table to correct results for parameters that were meas-
ured at temperatures above or below 25 °C.
Parameter Equation for temperature correction
pH pHcorrected to 25 °C = pHmeasured – A (t – 25)
pCO2 (pCO2)corrected to 25 °C = (pCO2)measured × [1 – A (t – 25)]
78
pO2 (pO2)corrected to 25 °C = (pO2)measured × [1 – A (t – 25)]
Example:
The pH calibration-verification measurement result was 7.100 for a level 1 solution.

The temperature of the ampoule during the measurement was 32 °C not 25 °C. The
result must therefore be corrected.
The temperature constant for a level 1 solution for pH is 0.0013.
The equation for temperature correction of pH values is:
pHcorrected to 25 °C = pHmeasured – A (t – 25) = 7.100 – 0.0013 (32 – 25) = 7.091
To use temperature-corrected calibration-verification results
Prerequisites: Temperature corrected calibration-verification results
1. Use the results to verify the reportable range of all measured parameters. Follow
your local, state or federal guidelines.
Stage 3 - Changing reportable ranges
To change the reportable range of parameters
Prerequisites: New reportable ranges established during calibration verification.
1. Tap Menu > Utilities > Setup > Analysis setup > Reportable ranges.
2. Select the parameter in the Parameters field.
3. Enter new values for the upper and lower limits of the reportable range.
4. If necessary, do steps 2 and 3 again for each parameter.
Reviewing QC statistics
To find and print QC statistics
Only QC results that are within the statistical range are included in the QC statistics.
Note: You can only print QC statistics for one month at a time.

2. Tap the Statistics button.
3. Tap the Next param．or Prev．param．button to see statistics for other parame-
ters.
79
4. Tap the Print button.

Option Steps
To print statistics for • Select the Print lot-to-date check button.

the lot to date • Tap the Print button.
Note: This option is only available when a minimum
number of QC measurements have been done.
To print statistics for • Select the Print for period check button.
a period • Select the calendar month period in the Print for
period frame.
• Tap the Print button.
Note: QC statistics are printed for all parameters.
Related information
Glossary of quality control terms, page 177
QC plots
QC plots are Levey-Jennings plots that show QC results done with registered QC solu-
tions. The results are shown on a horizontal time axis.
5
Slot A:S9030
1 7.194
6
2 8/12/2009
05:59 PM 7
3 7.170
8
4
7.154
10
1 Line to show the upper limit of the 6 Date that the highlighted QC meas-
control range of the solution urement was done
2 Line to show when the current 7 Time that the highlighted QC

control range of the solution was measurement was done
changed, or a new lot of the QC
solution was registered
3 Mean value of the control range of 8 QC result for the selected QC

the solution measurement
4 Line to show the lower limit of the 9 The absolute value of the lower
control range of the solution limit of the control range of the
solution
5 The absolute value of the upper 10 A previous QC measurement done

limit of the control range of the with the solution
solution
80
To find a QC plot
2. Tap the Plot button.
3. Select a parameter.
4. Tap the Ampoule QC <number...> button to see plots for ampoule-based QC
measurements.
5. Tap within the plot for a specific QC solution.
6. Use the scroll buttons to select and see details about specific QC measurements.
To filter data from the Quality control log

Option Action
today's date days you want.
fields.
4. Select the Solution.
5. Select the Lot.
6. If necessary, select other criteria.
To see trends in QC results
Prerequisite: You have filtered the QC results from the Quality control log.

2. Select check buttons for the parameters you want to see trends of.
WDC file export
About WDC
WDC is the abbreviation for Worldwide DATACHECK system. You can send a WDC file to
Radiometer's QA Portal, where you can compare the performance of your analyzer with
the performance of the same type of analyzer in various peer groups.
For more information on Worldwide Data Check, see QA Portal Operator’s manual.
81
To export WDC files
Prerequisites:
• A storage device (for example, a USB flash drive or an external network)
• A folder for the monthly statistics has been created on the device
This procedure lets you export monthly quality control data to the QA Portal. The data
is saved as a comma-separated file (a .csv file).
1. Connect the storage device to the analyzer.

2. Tap Menu > Utilities > Disk functions > WDC report.
3. Tap the button in the Destination frame.
4. Select the folder where the QC statistics are to be exported.
5. Tap the Back button.
6. Select the monthly period.
7. Give the file a name.
Note: All files names start with WDC_. You can only change the 4 characters that
follow.
8. Tap the Export data button.
If it is not possible to export the selected data, a pop-up message will be shown.
Analyzing QC solutions in other modes
About analyzing QC solutions in other modes
QC solutions may be analyzed in other modes than the Ampoule - QC mode. However,
when this is done, the results must be temperature-corrected manually.
To temperature correct results based on QUALICHECK5+ solutions
ampoule during measurements was above or below 25 °C.
1. Find the temperature constant (A) in the table.
Radiometer QUALICHECK5+ quality control solutions
Parameter Temperature constants (A)
Level 1 – S7730 Level 2 – S7740 Level 3 – S7750 Level 4 – S7760
pH 0.0018 0.00113 0.000703 0.00163
pCO2 0.00482 0.00231 0.000676 0.00657
pO2 0.00982 0.00986 0.00915 0.0107
2. Find the temperature constant (B) in the table.
Parameter Temperature constants (B)
pH 0.0000220 0.0000180 –0.0000260 0.0000209
pCO2 0.0000617 0.0000394 0.0000195 0.000117
82
Parameter Temperature constants (B)
pO2 –0.0000327 –0.000115 0.0000177 –0.00000876
3. Use the equations in the table to correct results for parameters that were meas-
ured at temperatures above or below 25 °C.
pH pHcorrected to 25 °C = pHmeasured – A (t – 25) – B(t – 25)2
pCO2 (pCO2)corrected to 25 °C = (pCO2)measured × [1 +A (t – 25) + B(t –25)2 ]
pO2 (pO2)corrected to 25 °C = (pO2)measured × [1 +A (t – 25) + B(t –25)2]
83
84
Calibration 6
Calibrations - automatic and manual
A calibration makes sure that measurement results are accurate and reliable.
The analyzer calibrates most parameters automatically. Only, the sensitivity calibration
of the oximetry parameters must be done manually. On the analyzer, this calibration is
known as a tHb calibration.
If necessary, an extra calibration can be requested. The calibration materials in the

Solution Pack are used for this calibration as well as for the calibrations done automati-
cally.
Identification of calibrations in screens
Calibration type Location Calibration identifiers
Automatic calibrations The Analyzer status Calibration

screen
The Calibration log BG pO2

screen
BG, Met pCO2, cGlu, cLac
Elec, pH pH, cK+, cNa+, cCa2+,

cCl–
Oxi Oximetry parameters
Manual calibration of the The Analyzer status tHb Cal

oximetry parameters screen
The Calibration log tHb calibra- Sensitivity calibration

screen tion of the oximetry
parameters
Manual calibration of the oximetry parameters
On the analyzer a manual calibration of the oximetry parameters is known as a tHb

calibration. The calibration adjusts the optical system of the analyzer to make sure that
the results of the oximetry parameters are accurate and reliable.
Frequency of automatic calibrations
Automatic calibrations are scheduled by default to be done at regular intervals. Auto-

matic calibrations are also done in connection with replacements, troubleshooting and
startup.
85
Chapter 6: Calibration ABL90 FLEX: Instructions for use
Start of the system-check cycle
System checks
Built-in QC measurements
Sensitivity calibration of pCO2, cGlu, cLac and status calibration of the oximetry parameters
Sensitivity calibration of pH and the electrolytes (cK+, cNa+,cCa2+, cCl–)
Sensitivity calibration of pO2
Related information
Calibration frequency after a Sensor Cassette replacement, page 40
To find the status of calibrations

2. Tap the Calibrations button.
Note: A symbol in the Calibration Type column shows the status of a calibration.
Symbols that show the calibration status
Symbol Indication
The calibration was completed successfully
An error was found on one or more calibration result
A scheduled calibration is pending. The last calibration was completed successfully.
A scheduled calibration is pending. The last calibration was not completed successfully.
86
ABL90 FLEX: Instructions for use Chapter 6: Calibration
Automatic calibrations
To request an unscheduled calibration from the Analyzer status

screen
2. Tap the Calibrations button.
3. Select Calibration as the Calibration Type.
4. Tap the Calibration button.
To request an unscheduled calibration from the menu
Prerequisite: Make sure that the analyzer is Ready.
1. Tap Menu > Start programs > Calibration programs > Calibration.
Manual tHb calibrations
To do a tHb calibration
Prerequisites:
A S7770 ctHb calibration ampoule An Ampoule Opener A QUALICHECK Adapter
• The box that contains the S7770 ctHb calibration ampoule has been stored at a
constant temperature (18-32 °C) for 5 hours
• Make sure that there are no calibration errors on the tHb parameter

1. Remove an ampoule from its box.

3. Hold the ampoule between your thumb and first finger and shake it vigorously for
a minimum of 15 seconds.
4. Hold the ampoule neck-side up between your fingers and tap the top until all solu-
tion collects in the lower part of the ampoule.
87
6. Use your fingers to apply pressure in the directions shown to break off the neck of
the ampoule.
7. Remove the ampoule from the Ampoule Opener.

9. Tap Menu > Start programs > Calibration programs > tHb calibration.
10. Scan the barcode on the insert for the S7770 ctHb Calibration Solution.
11. Lift the inlet handle of the analyzer to the syringe position.
upwards.
13. Put the QUALICHECK Adapter with the ampoule over the Inlet Gasket.
88
there.
you to remove it.
16. When the analyzer tells you to, remove the adapter with the ampoule.
Note: Sensitivity results between 80 % and 120 % without errors are acceptable.
Calibration results
To find a calibration result

1. Tap Menu > Data logs > Calibration log.
2. Select the calibration.
Note: BG = pO2 calibrations; BG, Met = pCO2, cGlu, cLac calibrations; Elec, pH
= pH, cK+, cNa+, cCa2+, cCl– calibrations and Oxi = oximetry parameter calibra-
tions.
Identification of calibrations in the Calibration log screen
Calibration identifiers Parameters
BG pO2
BG, Met pCO2, cGlu, cLac
Elec, pH pH, cK+, cNa+, cCa2+, cCl–
Oxi Oximetry parameters
89
Understanding calibration results
Font style Description
Bold black A result from the current calibration
Dark grey A result from a previous calibration. The result is still valid.
Red and Bold red An error occurred. A message attached to the result describes the error.
Symbol Description
? An error occurred or the result is outside a recommended range:

• Drift value is outside the drift tolerance range
• Status value is outside the default range
• Sensitivity value is outside the default range
..... The analyzer could not calculate the value
To see messages on a calibration result

2. Select the calibration.

Reviewing calibration results
To filter data from the Calibration log

3. In the Criteria frame, choose an option and follow the steps for it:
Option Steps
today days you want
fields
5. Do step 4 again for each criterion.
90
To see trends in calibration results
Prerequisite: You have filtered the calibration results from the Calibration log.

2. Select the parameter.
Status in the Calibration log screen
The symbols in the Status column of the Calibration log screen shows the overall
status of each calibration.
Symbol Description
The calibration was successful
An error was found on one or more parameters
91
92
Troubleshooting 7
Troubleshooting - when is it necessary?
Troubleshooting is necessary when the analyzer goes into a Operator Action Needed,
Troubleshooting needed or Intervention Required mode. It may also be neces-
sary to troubleshoot messages in the Analyzer status screen.
About guided troubleshooting
In the troubleshooting modes, Troubleshooting needed and Operator Action

Needed modes, text and video instructions guide you through each troubleshooting
procedure and show you what to do to get out of the troubleshooting mode.
After each troubleshooting procedure, the analyzer makes checks to find out if the
issue has been resolved. If not, a new troubleshooting procedure is shown on the
screen. If the guided troubleshooting procedures do not resolve the issue, the analyzer
will go into the Intervention Required.
To get out of Operator Action Needed mode

1. Follow the text and video instructions on the screen.
To get out of Troubleshooting needed mode

1. Follow the text and video instructions on the screen.
To get out of Intervention Required mode

1. Do the first action shown in the Suggested actions frame.
2. Tap the Test again button.
3. If the analyzer does not go out of Intervention Required mode, do the next
action.
5. If the analyzer does not go out of Intervention Required mode, do steps 3 and 4
again.
6. If none of the actions cause the analyzer to go out of Intervention Required
mode, contact your local Radiometer representative.
Troubleshooting modes - causes
Troubleshooting mode Possible causes
Operator Action Needed • The inlet was opened when the analyzer was not in Ready
mode
• The inlet was not closed after a measurement
• A consumable must be replaced
93
Chapter 7: Troubleshooting ABL90 FLEX: Instructions for use
Troubleshooting mode Possible causes
Troubleshooting needed • Fluid transport errors were found
Intervention Required • If the troubleshooting procedures in the Troubleshooting

needed mode did not resolve the issue
• All other possible errors
To find and troubleshoot messages in the Analyzer status screen
Prerequisite: The traffic light in the Analyzer status button is yellow or red.

2. Tap the button adjacent to a yellow or red traffic light.
Option Steps
To troubleshoot a Follow the instructions on the screen

Recommended
action
To troubleshoot To troubleshoot errors in the Built-in QC and

Quality control Ampoule-based QC fields:
messages a) Select the quality control measurement marked by a ,
or symbol.
To troubleshoot messages in the QC Messages field:
To troubleshoot To troubleshoot calibrations marked by a , or

Calibrations
symbol.
messages
a) Select the marked calibration.
To troubleshoot messages in the Message field:
To troubleshoot a) Select the message.

Consumables or b) Tap the Troubleshoot button.
System
messages c) Follow the instructions on the screen.
Related information
About guided troubleshooting, page 93
94
ABL90 FLEX: Instructions for use Chapter 7: Troubleshooting
To flush the fluid transport system
Prerequisites:
An ABL90 FLEX Flush Device A paper tissue or a cloth

Make sure that you wear gloves during replacement and maintenance procedures.
Note: The analyzer will automatically start the workflow for the flush of the fluid trans-
port system when necessary.
1. Draw tap water into the Flush Device up to the 2.5 mL mark.
2. Pull the plunger of the Flush Device up to the 5 mL mark to draw air into it.
4. When the analyzer tells you to, lift the inlet handle to the capillary position.
5. Wait until the Solution Pack is ejected.

6. Remove the Solution Pack.
7. Close the inlet handle.

8. Put a tissue or a cloth under the Inlet Gasket Holder.
95
10. Connect the tip of the Flush Device to the waste connector in the Solution Pack
compartment.

12. Hold the Flush Device as shown.
13. Inject a very small quantity of air to fill approximately 1 cm of the tube.
14. Hold the Flush Device as shown.
15. Inject a very small quantity of water to fill approximately 1 cm of the tube.
16. Do steps 12 to 15 again several times until the tube is full of water and air
bubbles.
96
18. Hold the Flush Device as shown and push the Inlet Gasket Holder up as far as it
will go (approximately 1 cm) and hold it there.
19. Inject water until an unbroken stream of water comes out of the Inlet Probe.
Note: The fluid path is flushed, when this is possible.
Note: If it is not possible, do steps 12 to 15 and step 19 again.
21. Disconnect the Flush Device.
22. Remove the tissue or a cloth.
25. Put your thumbs on the white part of the Solution Pack and push the Solution Pack
into its compartment until it clicks in place.
26. When the analyzer tells you to, close the inlet.
97
Operator actions requested in analyzer messages
To request a tubing refill

1. Tap Menu > Start programs > Auxiliary programs > Tubing refill.
To request a liquid sensor adjustment
Note: This procedure measures and adjusts the settings of the liquid sensors.
1. Tap Menu > Start programs > Auxiliary programs > Liquid sensor adjust.
To request a pump calibration
Note: This procedure makes sure that the pumps in the analyzer operate correctly.
1. Tap Menu > Start programs > Auxiliary programs > Pump calibration.
To request a rinse
Note: This procedure starts a rinse process. A rinse is also done after all measurement
activities.
1. Tap Menu > Start programs > Auxiliary programs > Rinse.
Troubleshooting Analyzer messages
To troubleshoot Analyzer messages
This procedure can be used to find out what operator actions are necessary to trouble-
shoot messages.
1. Note the message number (on the left of the message).

2. Find the message and operator actions in the Analyzer messages table.
Note: The messages in the table are sorted by number.
Note: If more operator actions are available, start with the first action listed and
see if this resolves the issue. If not, continue with the next action listed.
Analyzer messages
No. Message Interpretation Action
1 Inconsistent soft- Inconsistent software versions for - Contact Radiometer service represen-
ware versions. different modules. May appear after tative.
Please contact replacing a complete module or as a
service result of an incomplete software
upgrade.
83 Value above refer- The parameter value is above the No action required.
ence range user-defined reference range. This is
only a message, not an error.
98
84 Value below refer- The parameter value is below the No action required.
ence range user-defined reference range. This is
only a message, not an error.
85 Value below critical The parameter value is below the No action required.
limit user-defined critical limit. This is only a
message, not an error
86 Value above critical The parameter value is above the No action required.
limit user-defined critical limit. This is only a
message, not an error.
89 Measured QC value The measured parameter value is above - Verify the procedure and repeat the
above control the control range. measurement.
range
- See the "Instructions for use".
90 Measured QC value The measured parameter value is below - Verify the procedure and repeat the
below control range the control range. measurement.
- See the "Instructions for use".
93 Value above report- The parameter value is above the report- - Check for and remedy other errors
able range able range. related to the result, system messages
or calibration status.
- Perform QC. If the QC result is

accepted, the blood sample may be
suspected.
- Perform measurement on new blood

sample.
94 Value below report- The parameter value is below the report- - Check for and remedy other errors
able range able range. related to the result, system messages
or calibration status.
- Perform QC. If the QC result is

accepted, the blood sample may be
suspected.
- Perform a measurement on new blood

sample.
117 LIS/HIS: Invalid The communication configuration or the Check the communication parameters
connection configu- protocol definition was invalid. specified in Communications Setup.
ration
128 LIS/HIS: Failed to The communication hardware was busy - Check that the remote system is
open connection or the remote system did not respond. running, correctly configured and
responding.
- Check communication parameters, e.g.

baud rate, parity, IP address, etc., as
defined in Communication Setup.
- Reboot the analyzer.
129 LIS/HIS: Failed to Messages were queued when the If the problem persists, check the
close connection communication channel was closed. communication hardware. The remote
Results and other messages sent by the system may lack buffer capacity.
analyzer to a remote system may be
lost.
99
131 LIS/HIS: Failed to A communication error occurred while - Check that the remote system is
send packet sending a message. The message was running and responding.
not sent.
- Check the communication hardware,
including cables.
- Repeat sending.
132 LIS/HIS: Failed to An error occurred while receiving a - Check that protocol types are correctly
receive packet message. The analyzer was not able to configured on both the analyzer and the
recognize the received massage. remote system.
- Contact Radiometer service represen-

tative.
133 LIS/HIS: Connec- A previously established LIS/HIS - Check that the remote system is
tion lost connection has been lost. running and responding.
- Check cables.
134 LIS/HIS: Connec- The connection was successfully estab- No action required. For information only.
tion established lished.
165 LIS/HIS: High-level An error occurred while formatting a Check protocol configurations. Contact
protocol could not message. Radiometer service representative.
generate high-level
packet
166 LIS/HIS: General An internal error occurred in the LIS/HIS Contact Radiometer service representa-
communication communication module. tive if the problem persists.
error
167 LIS/HIS: High-level An error occurred while parsing (inter- Check protocol configurations. Contact
protocol received preting) a message. Radiometer service representative.
packet in wrong
format
200 Operator msg: This is only a message. An operator has No action required.
entered a note in the log.
201 Westgard Rule Measured parameter value is outside the - Verify procedure and repeat measure-
(1.2s) violation mean +/- 2 SD range. ment.
- Check Replacement Status for pending

replacements.
- See the "Instructions for use" for

detailed evaluation procedure.
202 Westgard Rule Measured parameter value is outside the - Verify procedure and repeat measure-
(1.3s) violation mean +/- 3 SD range. ment.
- Check Replacement Status for pending

replacements including elctrodes.

203 Westgard Rule Two consecutive measurements are - Verify procedure and repeat measure-
(2.2s) violation outside the mean +/- 2 SD range on the ment.
same side of the mean. This may indi-
cate a shift. - Check Replacement Status for pending
replacements including electrodes.

100
204 Westgard Rule (R. The difference between two consecutive - Verify procedure and repeat measure-
4s) violation measurements exceeds 4 SD. This may ment.
indicate an inconsistency in your proce-
dure or an unstable analyzer. - Check Replacement Status for pending
electrode replacements.

205 Westgard Rule Four consecutive measurements are - Check for excessive electrode sensor
(4.1s) violation outside the mean +/- 1 SD range on the calibration drift.
same side of the mean. A trend or shift
is indicated. Patient results should be - Check Replacement Status for pending
considered unreliable until the problem electrode replacements.
is remedied.
- See the "Instructions for use" for eval-
uation procedure.
206 Westgard Rule Ten consecutive measurements are on - Check the electrode drift during last
(10.x) violation the same side of the mean. A trend or calibration.
shift is indicated. Patient results should
be considered unreliable until the - Check Replacement Status for pending
problem is remedied. electrode replacements.
- See the "Instructions for use" for eval-

uation procedure.
207 Calibration One or more scheduled calibrations are Check the Calibration Status and
schedule overdue. perform any pending calibrations.
reminder(s)
present
208 Quality control One or more scheduled QC measure- Check the Quality Control Status and
schedule ments are overdue. perform the pending quality control.
reminder(s)
present
209 Replacement One or more scheduled replacements Check the Replacement Status and
schedule are overdue. perform any pending replacement
reminder(s) actions.
present
210 Calibration error(s) An error registered on one or more Check Calibration Status for errors in
present parameters during the last calibration. latest calibration results for the given
parameter. View calibration error
messages and take required corrective
action.
211 Quality control One or more errors were registered Check Quality Control Status for errors.
error(s) present during last QC measurement on one of View QC error messages and take
the installed QC levels. required corrective action.
212 System One or more systems errors are present. Check the System Messages Status for
message(s) errors. Take corrective required action.
present
213 Automatic backup An error occurred during the scheduled - Check Automatic Backup Setup.
failed data backup.
- Check network and servers used for
the backup.
- Contact your IT engineer.
214 Automatic backup The scheduled automatic backup was No action required.
succeeded completed successfully.
101
216 General printer A printer problem has occurred, e.g. the - Check printer paper. Clear any jam.
error paper is jammed
- Power down and restart the analyzer.

tative.
217 Replacement: The message is used in the Activity Log No action required.
to indicate a performed replacement.
290 Warning: SHb FSHb detected in the range of 1-10 %. No action required. For information only.
detected
291 SHb too high Detected FSHb is greater than 10%. - Repeat the measurement.
Measurement accuracy is affected.
292 Turbidity too high Turbidity is greater than 5 %: too high - Hyperlipemic sample; decrease the
for reliable measurements. lipemic content by e.g. centrifuge or
extraction.
- Perform the measurement on a blood

sample from a healthy donor.

tative.
293 Oxi compensated OXI parameters have been HbF compen- No action required. For information only.
for HbF sated. Parameter FHbF may be shown or
not shown.
329 QC expiration date The quality control measurement was - Discontinue the use of the lot and set
exceeded performed on an expired control solu- up a valid lot for the control solution.
tion.
331 No sample No sample detected in sensor. Measure- - Ensure that adequate sample volume is
detected during ment is aborted. used.
sample aspiration
- Check the sample for clots.
357 Temp. error: Temperature in the barometer on the - Ensure that the ambient temperature is
Barometer Analyzer Control is outside 37 +/- 1.0 between 15 and 32 °C.
°C.
- If the system has just performed a cold
start, wait for the error to disappear.
- Shield the analyzer from direct sunlight

and other heat sources.

tative.
375 Calibration status The status value is outside the range for - Check for and remedy any system
out of limits the given parameter. messages.
- Repeat the calibration.
- Check solution pack status and

replace, if necessary.
- Check sensor cassette status and

102
376 Calibration Drift 1 The Drift 1 value exceeds the tolerance. - Check for and remedy any system
out of range messages.


377 Calibration Drift 2 The Drift 2 value exceeds the tolerance. - Check for and remedy any system
out of range messages.


378 Calibration sensi- The sensitivity value is out of range for - Check for and remedy any system
tivity out of range the given parameter. messages.


379 Calibration An electrode response fault occurred - Check for and remedy any system
unstable (response during calibration. messages.
fault)


443 Ca(7.4) not usable cCa2+ at a pH of 7.4 is not usable as the No action required.
actual pH is outside the 7.2-7.6 range.
452 Interference during Interference was detected during meas- Check the patient record for medication
measurement urement. containing possible interfering
substances.
484 Today is last day in After the current day, quality control Print the QC statistics if a copy is
stat. month - statistics obtained over the month will required.
remember to print be deleted and new statistics started.
QC statistics
487 A new statistical A new statistical month has begun. Make a WDC report disk.
month has begun -
remember to
export WDC data
494 Bilirubin too high Detected bilirubin concentration, No action required.

ctBil(blood), is greater than 2000
µmol/L. The corresponding plasma bilir-
ubin concentration can be calculated as
follows: ctBil(blood) = (1-Hct) ×
ctBil(plasma).
103
508 Liquid transport Liquid transport of Rinse failed - Check solution pack or sensor cassette
error during rinse status and replace, if necessary.
512 Temperature error The temperature was outside the - Ensure that the ambient temperature is
required range during measurement or between 15 and 32 °C.
calibration. All results are marked with
"?". - If the analyzer has recently performed
a cold start, wait for the temperature
error to disappear.
- If the solution pack or sensor cassette

has recently been replaced, wait for the
temperature error to disappear.
- Shield analyzer from direct sunlight or

heat sources.

tative.
521 Inhomogeneous Air bubbles were detected in the sample. - Repeat the measurement.
sample Results may have "?".
522 Calibration error One or more calibration values are erro- - Check for and remedy any system
neous. messages.


523 Calibration drift out Calibration drift exceeds defined limits. - Check for and remedy any System
of range Messages.
- Perform any pending replacements

including electrodes.
- Check that electrodes are properly

installed.
- Verify that proper solutions and gases

are used.
- Perform the Electrode Troubleshooting

procedure.
529 Inlet LS failed to Inlet liquid sensor failed to calibrate. - Repeat the liquid sensor calibration.
calibrate
tative.
531 Sensors LS failed Liquid sensor near the sensor cassette - Repeat the liquid sensor calibration.
to calibrate failed to calibrate.
- Check solution pack status and replace
if necessary.

tative.
537 OXI LS failed to OXI module liquid sensor failed to cali- - Repeat the liquid sensor calibration.
calibrate brate.

tative.
104
581 OXI spectrum Spectrum deviates from the expected - Check the patient record for medica-
mismatch blood or QC spectrum. Measurement tion containing possible interfering
may be unrealiable. substances.
- Start a calibration.

tative.
582 tHb calibration tHb calibration failed. - Perform a calibration.

cuvette factor
outside limits - Repeat the tHb calibration.

tative.
584 tHb calibration tHb calibration failed. - Perform a calibration.

wavelength outside
limits - Repeat the tHb calibration.

tative.
588 Measured QC value The parameter value is below the lower - Verify the procedure and repeat the
lower than statis- limit of the operator-defined statistical measurement.
tical range range. Measurement is not included in
statistics. - See the "Instructions for use" for
details on the evaluation of the results.
589 Measured QC value The parameter value is above the upper - Verify the procedure and repeat the
higher than statis- limit of the operator-defined statistical measurement.
tical range range. Measurement not included into
statistics. - See the "Instructions for use" for
details on the evaluation of the results.
593 Insufficient sample Sample volume is too small for the - Repeat the measurement, ensuring
selected measuring mode. Affected sufficient sample volume.
parameters will be marked with "?".
tative.
595 Liquid sensor cali- One or more of the liquid sensors failed - Repeat the liquid sensor calibration.
bration error calibration.

tative.
606 Cal expired (pH) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".
608 Cal expired (pCO2) Too long time passed since the last Perform a calibration.
609 Cal expired (pO2) Too long time passed since the last Perform a calibration.
610 Cal expired (K) Too long time passed since the last Perform a calibration.
105
611 Cal expired (Na) Too long time passed since the last Perform a calibration.
612 Cal expired (Ca) Too long time passed since the last Perform a calibration.
613 Cal expired (Cl) Too long time passed since the last Perform a calibration.
614 Cal expired (Glu) Too long time passed since the last Perform a calibration.
615 Cal expired (Lac) Too long time passed since the last Perform a calibration.
616 Cal expired (OXI) Too long time elapsed since the last Perform a calibration.
641 ABL/DMS PC The analyzer was restarted from power No action required. For information only.
restarted off.
642 ABL/DMS PC Added by DMS PC when connection to - No action required.

connected to wet the wet section is obtained.
section
643 ABL/DMS PC The connection from the DMS PC to the - Shut down and restart the analyzer.
disconnected from wet section is lost.
wet section - Contact Radiometer service represen-
tative.
648 Calibration failed or The last calibration was aborted or not - Check solution pack status and
not accepted accepted. replace, if necessary.

- Check for and remedy system

messages.
662 Barometer out of Measured barometer value is outside the - Contact Radiometer service represen-
range measuring range: 60-106.7 kPa. tative.
669 QC value outside Measured parameter value is outside - Verify the procedure and repeat meas-
control range control range. urement.
- Refer to Quality Control Systems Refer-

ence Manual.
679 Barometer error The measured parameter may be unreli- Contact Radiometer service representa-
able due to barometer error. tive.
106
682 OXI module not The OXI module is not responding due to - Shut down the analyzer, using the
active an internal communication problem, or Temporary Shutdown function; then
the software configuration does not restart it.
match the analyzer type.
tative.
688 ctHb/ceHb too low ctHb < 1 mmol/L, or ceHb < 0.75 If Oxi derivates are wanted, elevate tHb
for OXI calculation mmol/L. If ctHb is too low, FHHb, and/or sO2.
FO2Hb, FCOHb and FMetHb are not
calculated. If ceHb = cHHb + cO2Hb is
too low, sO2 is not calculated.
692 ABL not connected The analyzer is not connected to - Contact your RADIANCE/IT engineer.
to RADIANCE RADIANCE.
- Check RADIANCE Communication
Setup including TCP/IP address, port no.
and password.
- Check that RADIANCE is responding.
- Check network connections.
693 ABL not connected The analyzer was refused connection to Enter the correct password in the
to RADIANCE - RADIANCE due to incorrect password. analyzer's RADIANCE Communication
incorrect password Setup.
694 ABL connected to The analyzer is connected to RADIANCE. No action required.

RADIANCE
695 ABL disconnected The analyzer was disconnected from No action required.
from RADIANCE RADIANCE.
696 ABL<>RADIANCE Communication error between the Contact Radiometer service representa-
communication analyzer and RADIANCE. tive.
error
699 Built-in QC meas- The analyzer was set up to perform Check Calibration Status and remedy
urement started built-in QC measurements in case of any reported calibration errors.
due to calibration calibration errors.
error
700 Scheduled built-in Last calibration contained an error, and Check Calibration Status and remedy
QC not run due to the analyzer was set up to suspend calibration errors.
errors in last cali- built-in QC measurements in case of
bration calibration errors.
703 QC expired QC measurement is overdue (corrective Perform a quality control measurement.

action "Lock analyzer" has been selected
in the Setup program: Corrective
Actions).
704 Built-in QC meas- The scheduled QC measurement was not No action required.
urement is accepted; the measurement was
repeated repeated as requested in the Setup
program: Corrective Actions.
705 Built-in QC meas- The scheduled QC measurement was not No action required.
urement is accepted; the measurement was
repeated twice repeated twice as requested in the Setup
program: Corrective Actions.
107
707 Replacement(s) Replacement is overdue by 10 % - Check Replacement Status and replace

overdue by 10 %. (corrective action "Lock analyzer" was as required.
Analyzer locked. selected in the Setup program: Correc-
tive Actions). When the analyzer is - Unlock analyzer in the Miscellaneous
locked, scheduled calibrations are Setup program.
performed, but no patient samples or QC
measurements are allowed.
708 Corrective action Scheduled built-in QC measurement was Insert a new solution pack.
not possible due to requested, but the solution pack was
empty solution empty.
pack
712 FHbF measurement Composition of the blood sample makes If FHbF is wanted change sample
not possible FHbF measurement too inaccurate, but composition. For example, elevate sO2
OXI parameters are compensated for and tHb.
HbF. See explanation in the "Instructions
for use".
713 ctBil measurement Blood sample ctHb is so high that hardly If ctBil is wanted, lower the ctHb value.
not possible any plasma is left to measure plasma
biliribin on. ctHb > 14.56mmol/L.
734 General WSM The data management system estab- - Wait a few minutes for the connection
exception lishes connection to the analyzing unit, to establish.
or the connection is lost.
- Restart the analyzer.
- If the error persists, contact

Radiometer service representative.
745 Low disk space Free disk space is low. Move archive files to another storage
device.
766 ABL not connected The analyzer has been refused connec- Contact RADIANCE/IT engineer or
to RADIANCE - no tion to RADIANCE because there is no Radiometer service representative.
RADIANCE connec- connection license available on
tion license RADIANCE.
to RADIANCE - ABL tion to RADIANCE because the ABL Stat- Radiometer service representative.
StatLink version Link version is higher than the
too high RADIANCE StatLink version.
to RADIANCE - ABL tion to RADIANCE because the ABL Stat- Radiometer service representative.
StatLink version Link version is lower than the RADIANCE
too low StatLink version.
769 ABL<>RADIANCE Communication error between the Contact RADIANCE/IT engineer or

communication analyzer and RADIANCE. Radiometer service representative.
error - XML packet
could not be
parsed
770 Failed to restore The setup could not be restored. - Download the setup data from another
Custom Setup floppy disk, hard disk or network drive.

tative if the error persists.
771 Succeeded to Restoring of setup is completed. No action required.

restore Custom
Setup
772 Operator Activity: Operator activity logged by operator. No action required.
108
773 Remote operator A remote operator has logged on the No action required.
logged on with analyzer via NetOp.
operator:
774 Remote operator An operator, remotely logged on via No action required.

logged off with NetOp, has logged off, or has been
operator: logged off by a local operator.
775 Failed to restore Restoring analyzer setup to default Contact Radiometer service representa-
Default Setup values has failed. tive.
776 Succeeded to Restoring setup to default values is No action required.

restore Default completed.
Setup
780 RADIANCE commu- RADIANCE communication has been No action required. For information only.
nication enabled enabled as part of the RADIANCE
Connection Setup.
781 RADIANCE commu- RADIANCE communication has been No action required. For information only.
nication disabled disabled as part of the RADIANCE
Connection Setup.
782 RADIANCE output The output queue was cleared in the No action required. For information only.
queue cleared RADIANCE Connection Setup.
783 Automatic backup Automatic backup (selected in Disk No action required. For information only.
started Functions Setup) has started.
785 Automatic Automatic archiving (selected in Disk No action required. For information only.
archiving started Functions Setup) has started.
786 Automatic Automatic archiving (selected in Disk No action required. For information only.
archiving Functions Setup) completed successfully.
completed
787 Export of data logs Export of data logs was started by the No action required. For information only.
started operator.
798 Operator logged on Operator logged on successfully. No action required. For information only.
799 Operator logged off Operator logged off. No action required. For information only.
800 Logon attempt Operator tried to log on but did not Provide a valid password to log on.
failed provide a valid password.
810 pH locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.
811 pCO2 locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
109
812 pO2 locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
813 K locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
814 Na locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
815 Cl locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
816 Ca locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
818 Glu locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
819 Lac locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
820 tHb locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
821 MetHb locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
110
822 COHb locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
823 HHb locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
824 O2Hb locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
825 sO2 locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
826 HbF locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
827 tBil locked The parameter has been locked by a Await corrective actions initiated by the
patient results.
831 pH unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.
832 pCO2 unlocked The message is used in the Activity Log No action required. For information only.
833 pO2 unlocked The message is used in the Activity Log No action required. For information only.
834 K unlocked The message is used in the Activity Log No action required. For information only.
835 Na unlocked The message is used in the Activity Log No action required. For information only.
836 Cl unlocked The message is used in the Activity Log No action required. For information only.
111
837 Ca unlocked The message is used in the Activity Log No action required. For information only.
839 Glu unlocked The message is used in the Activity Log No action required. For information only.
840 Lac unlocked The message is used in the Activity Log No action required. For information only.
841 tHb unlocked The message is used in the Activity Log No action required. For information only.
842 MetHb unlocked The message is used in the Activity Log No action required. For information only.
843 COHb unlocked The message is used in the Activity Log No action required. For information only.
844 HHb unlocked The message is used in the Activity Log No action required. For information only.
845 O2Hb unlocked The message is used in the Activity Log No action required. For information only.
846 sO2 unlocked The message is used in the Activity Log No action required. For information only.
847 HbF unlocked The message is used in the Activity Log No action required. For information only.
848 tBil unlocked The message is used in the Activity Log No action required. For information only.
852 RADIANCE: Message from RADIANCE. No action required. For information only.
855 Base Excess out of Base Excess exceeds the +/- 30 mmol/L For information only. No analyzer error
range range. was detected.
875 Sample aged The specified limit for sample age has Draw and analyze new sample.
been exceeded.
885 Cyclic QC schedule The cyclic QC schedule has been reset No action required. For information only.
reset from and all related reminders have been
RADIANCE removed as a result of a RADIANCE
command.
886 LIS/HIS: No valid A file with a valid Device ID does not Contact Radiometer service representa-
POCT1A DML exist. A valid Device ID is needed in tive to obtain a Device ID file.
Device ID file order to use the POCT1A DML protocol.
963 Leak current in Leak currents were detected during - Replace inlet connector gasket, sensor
analyzer detected system calibration and may distort cassette or solution pack.
measuring results.
tative.
112
964 Leak current in Leak currents were detected during - Replace solution pack.
relation to solution system calibration and may distort
pack detected measuring results. - Contact Radiometer service represen-
tative.
970 Replace solution This message is shown when the solu- - Replace solution pack.
pack tion pack needs to be replaced. The
analyzer will enter "Operator-interven-
tion required".
971 Replace sensor This message is shown when the sensor - Replace sensor cassette.
cassette cassette needs to be replaced. The
analyzer will enter "Operator-interven-
tion required".
973 Printer paper must No more paper in printer. Insert new printer paper.
be replaced
978 Flow selector cali- Shown in the Activity Log when "Oper- The analyzer will automatically enter
bration error ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.
979 Inhomogeneous Shown in the Activity Log when "Oper- The analyzer will automatically enter
rinse solution ator-intervention required" has been "Operator-intervention required". Follow
983 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
3 solution ator-intervention required" has been "Operator-intervention required". Follow
984 The analyzer could Shown in the Activity Log when "Oper- The analyzer will automatically enter
not aspirate homo- ator-intervention required" has been "Operator-intervention required". Follow
geneous calibration entered due to this reason. the instructions shown on the screen.
solution
1000 Number of pO2 Can be shown on a result if unable to - Restart the analyzer.
hardware data fail calculate oxygen due to an unexpected
system error. - Perform a calibration.

tative.
1001 Timeout while Can be shown on a result if unable to - Restart the analyzer.
waiting for pO2 calculate oxygen due to an unexpected
hardware data system error. - Perform a calibration.

tative.
1002 pO2 dark data is Can be shown on a result if unable to - Restart the analyzer.
out of range calculate oxygen due to an unexpected

tative.
1004 Unable to calculate Can be shown on a result if unable to - Restart the analyzer.
oxygen parameter calculate oxygen due to an unexpected

tative.

tative.
113

tative.
1007 Missing oxygen No calibration data exists for oxygen. Perform a calibration.
calibration

tative.

tative.
1010 Oxi data collection Oxi hardware problem - Restart the analyzer.
error
- Perform a calibration.

tative.
1011 Oxi has no Blank Missing Blank Cal. Not necessarily a - Perform a calibration.
Cal hardware error.

tative.
1012 Oxi has no sample The system has not made a sample - Repeat the measurement.
spectrum measurement yet, or there is a hardware
problem. - Restart the analyzer.

tative.
1013 Oxi data collection Oxi hardware error - Restart the analyzer.
error

tative.
1014 Oxi Blank Cal. The spectrometer received too high light - Check solution pack. During Oxi Blank
intensity too high intensity during Blank Cal. calibration, the cuvette must be filled
with liquid.

tative.
1015 Oxi sample inten- The spectrometer received too high light - Check solution pack. During Oxi Blank
sity too high intensity during sample measurement. calibration, the cuvette must be filled
with liquid.
- Repeat the sample measurement.
114
1016 Oxi Blank Cal. The spectrometer received too low light - Perform a calibration.
intensity too low intensity during Blank Cal.

tative.
1017 Oxi sample inten- The spectrometer received too low light - Restart the analyzer.
sity too low intensity during sample measurement.

tative.
1018 Oxi electronic Oxi hardware problem. - Restart the analyzer.

adjustment error

tative.
1019 Oxi Blank Cal. Peak value of Blank Cal. spectrum inten- - Check solution pack. The cuvette must
outside limits sity is outside acceptance limits. be filled with liquid during Blank calibra-
tion.

tative.
1020 Oxi neon intensity Oxi hardware problem. - Restart the analyzer.
outside limits

tative.
1021 Oxi neon correction Oxi hardware problem. - Restart the analyzer.
outside limits
tative.
1022 Oxi background Oxi hardware problem. - Restart the analyzer.

correction outside
limits - Contact Radiometer service represen-
tative.
1023 Oxi spectrometer Oxi hardware problem. - Restart the analyzer.

memory read
problem - Contact Radiometer service represen-
tative.
1024 Oxi spectrometer Oxi hardware problem. - Restart the analyzer.

memory write
problem - Contact Radiometer service represen-
tative.
1025 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer

tuning problem
tative.
1026 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer.

frequency problem
tative.
115

temperature devia-
tion too high - Contact Radiometer service represen-
tative.
1028 Oxi neon voltage Oxi hardware problem. - Restart the analyzer.
outside limits
tative.
1029 Oxi light source Oxi hardware problem. - Restart the analyzer.
voltage outside
tative.

voltage outside
tative.
1031 Oxi initialization in Oxi initialization in progress. - Please wait up to 50 minutes before
progress restarting the analyzer.

tative.
1032 Oxi data collection Oxi hardware problem. - Restart the analyzer.
problem
tative.
1033 Oxi task was not Internal software problem. - Restart the analyzer.
finished
tative.
1034 Oxi hardware An Oxi hardware problem has occurred. - Restart the analyzer.
problem

tative.
1045 Unable to read Unable to read information stored on - Reinstall the solution pack and sensor
consumable infor- either sensor cassette or solution pack. cassette.
mation

tative.
1061 Pressure test flow The sample transport through the The analyzer will automatically enter
error analyzer is hindered. "Operator-intervention required". Follow
the instructions shown on the screen.
1062 Pressure test pres- A leak has been found in the solution The analyzer will automatically enter
sure error transport. "Operator-intervention required". Follow
1063 Pressure test A leak has been found in the solution The analyzer will automatically enter
vacuum error transport. "Operator-intervention required". Follow
116
1064 Temperature in Hardware temperature error. - Ensure that the ambient temperature is
sensor cassette top between 15 and 32 °C.
out of range


tative.
sensor cassette between 15 and 32 °C.
bottom out of
range - If the system has just performed a cold


tative.
sensor cassette between 15 and 32 °C.
substrate out of
range - If the system has just performed a cold


tative.
1069 Temperature in Oxi Hardware temperature error. - Ensure that the ambient temperature is
cuvette out of between 15 and 32 °C.
range


tative.
1070 Sensor response Unstable signal from sensor. Repeat measurement

error
1071 Temperature in Oxi Hardware temperature error. - Ensure that the ambient temperature is
spectrometer out between 15 and 32 °C.
of range


tative.
1079 Sensor impedance Sensor impedance error - Perform calibration

error
- Replace sensor casette
rinse solution ator-intervention required" has been "Operator-intervention required". Follow
117
1085 Inhomogeneous Bubbles were detected in the QC1 solu- - Perform a refill from the auxiliary
QC1 solution tion. program.
- Replace the solution pack.
gas ator-intervention required" has been "Operator-intervention required". Follow
1090 No rinse solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
1092 No cal 2 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
1093 No cal 3 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
1094 No QC1 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
1098 No gas Shown in the Activity Log when "Oper- The analyzer will automatically enter
1099 Pump calibration Shown in the Activity Log when "Oper- The analyzer will automatically enter
error ator-intervention required" has been "Operator-intervention required". Follow
1100 Outlet LS not Shown in the Activity Log when "Oper- The analyzer will automatically enter
empty during pump ator-intervention required" has been "Operator-intervention required". Follow
calibration entered due to this reason. the instructions shown on the screen.
1101 Outlet LS not full Shown in the Activity Log when "Oper- The analyzer will automatically enter
during pump cali- ator-intervention required" has been "Operator-intervention required". Follow
bration entered due to this reason. the instructions shown on the screen.
118
1111 Inhomogeneous air Shown in the Activity Log when "Oper- The analyzer will automatically enter
1112 LS inlet not empty Shown in the Activity Log when "Oper- The analyzer will automatically enter
1113 LS sensors not Shown in the Activity Log when "Oper- The analyzer will automatically enter
empty ator-intervention required" has been "Operator-intervention required". Follow
1114 LS outlet not Shown in the Activity Log when "Oper- The analyzer will automatically enter
1115 Ws communication Internal communication error. - Restart the analyzer.

error: wrong
message format - Contact Radiometer service represen-
tative.
1116 Ws communication Internal communication error. - Restart the analyzer.

error: keep alive
timeout - Contact Radiometer service represen-
tative.
1117 Oxi spectrometer A large deviation in temperature has - Perform a calibration

temperature drift been observed. This is probably due to a
change in the ambient environment.
1120 Sensor replace- This message is shown in the Activity No action required. For information only.
ment successful Log following a successful replacement
of the sensor cassette.
1121 The port did not This message is shown in the Activity - Reinstall the sensor cassette.
open during sensor Log after a failed sensor cassette
replacement replacement. - Restart the analyzer.

tative.
1123 The sensor chip This message is shown in the Activity - Reinstall the sensor cassette.
data could not be Log after a failed sensor cassette
read or written replacement. - Restart the analyzer.
during replacement
tative.
1124 An unregistered This message is shown in the Activity No action required. For information only.
sensor was Log after a sensor cassette replacement,
installed during that did not identify a previously condi-
replacement tioned cassette.
1125 An unregistered This message is shown in the Activity No action required. For information only.
and used sensor Log after a sensor cassette replacement.
was installed It informs that the sensor cassette
during replacement installed is already used and no informa-
tion exists about the conditioning hereof.
1126 A registered sensor This message is shown in the Activity No action required. For information only.
had been used Log after a sensor cassette replacement.
before installation It informs that the sensor cassette
installed has been used before.
119
1134 The chip informa- This message is shown in the Activity - Reinstall the solution pack.
tion for the solution Log after a failed solution pack replace-
pack cannot be ment. - Restart the analyzer.
read or written
tative.
1135 The solution pack This message is shown in the Activity - Reinstall the solution pack.
has been used Log after a failed solution pack replace-
before ment.
1140 The solution pack This message is shown in the Activity - Reinstall the solution pack.
has used the Log after a failed solution pack replace-
maximum number ment.
of measurements
at installation
1142 The printer door is Printer door open. - Ensure that the printer paper is prop-
open. Printing not erly installed.
possible
- Close the printer door.
1143 Internal printer is Printer hardware error. - Ensure that the printer paper is prop-
offline. Printing not erly installed.
possible
1144 Check that printer Printer hardware error. - Ensure that the printer paper is prop-
door is closed and erly installed.
that paper is
present - Close the printer door.
1145 A printer error has Printer hardware error. - Ensure that the printer paper is prop-
occurred. Call erly installed.
service technician
1146 Printer paper This message is shown in the Activity No action required. For information only.
replaced Log after replacement of printer paper.
1147 Inlet opened during Shown in the Activity Log when "Oper- The analyzer will automatically enter
rinse ator-intervention required" has been "Operator-intervention required". Follow
1148 Inlet open during Shown in the Activity Log when "Oper- The analyzer will automatically enter
calibration ator-intervention required" has been "Operator-intervention required". Follow
1149 Inlet open during Shown in the Activity Log when "Oper- The analyzer will automatically enter
wet section activity ator-intervention required" has been "Operator-intervention required". Follow
1150 Inlet closed without This message is shown in the Activity No action required. For information only.
aspirating sample Log when a measurement has been
cancelled due to inlet being closed
before aspiration could be completed.
1151 Inlet not closed: no This message is shown in the Activity No action required. For information only.
sample aspirated Log when a measurement has been
cancelled due to inlet being closed too
late.
120
1152 The solution pack This message is shown in the Activity Repeat replacement operation.
chip data could not Log when a replacement of the sensor
be read or written cassette or solution pack has failed. The
during replacement reason was that it was impossible to
communicate with the chip on the
consumable.
1157 No valid FTC System error. Contact Radiometer service representa-

programs detected tive.
1160 The top termistor is The top termistor is not connected Restart the analyzer
not connected
- If still present replace top termistor
1161 The top termistor The top termistor short circuited Restart the analyzer
short circuited
- If still present replace top termistor
1163 The sensor The sensor cassette termistor is not Restart the analyzer
cassette termistor connected
is not connected - If still present replace sensor cassette
1164 The sensor Sensor cassette termistor is short Restart the analyzer
cassette termistor circuited
is short circuited - If still present replace sensor cassette
1165 Solution pack not Shown in the Activity Log when "Oper- The analyzer will automatically enter
properly installed ator-intervention required" has been "Operator-intervention required". Follow
1166 Solution pack Shown in the Activity Log when "Oper- The analyzer will automatically enter
expired ator-intervention required" has been "Operator-intervention required". Follow
1167 Sensor cassette not Shown in the Activity Log when "Oper- The analyzer will automatically enter
properly installed ator-intervention required" has been "Operator-intervention required". Follow
1168 Sensor cassette Shown in the Activity Log when "Oper- The analyzer will automatically enter
expired ator-intervention required" has been "Operator-intervention required". Follow
1169 Unable to pump Shown in the Activity Log when "Oper- The analyzer will automatically enter
solutions ator-intervention required" has been "Operator-intervention required". Follow
1170 Inlet has been Shown in the Activity Log when "Oper- The analyzer will automatically enter
open for too long ator-intervention required" has been "Operator-intervention required". Follow
1171 Inlet is missing or Shown in the Activity Log when "Oper- The analyzer will automatically enter
in unknown state ator-intervention required" has been "Operator-intervention required". Follow
1172 Sensor cassette Shown in the Activity Log when "Oper- The analyzer will automatically enter
damaged ator-intervention required" has been "Operator-intervention required". Follow
damaged ator-intervention required" has been "Operator-intervention required". Follow
1174 Inlet opened while Shown in the Activity Log when "Oper- The analyzer will automatically enter
the analyzer was ator-intervention required" has been "Operator-intervention required". Follow
busy entered due to this reason. the instructions shown on the screen.
121
1175 Sensor tempera- Hardware temperature error (Termistor). - Ensure that the ambient temperature is
ture error between 15 and 32 °C.



tative.
1176 A liquid sensor Shown in the Activity Log when "Oper- The analyzer will automatically enter
error was detected ator-intervention required" has been "Operator-intervention required". Follow
1177 A flow selector Shown in the Activity Log when "Oper- The analyzer will automatically enter
error was detected ator-intervention required" has been "Operator-intervention required". Follow
1178 A pump calibration Shown on screen when "Operator-inter- The analyzer will automatically enter
error was detected vention required" has been entered due "Operator-intervention required". Follow
to this reason. the instructions shown on the screen.
1180 An error occurred Shown in the Activity Log when "Oper- The analyzer will automatically enter
when trying to ator-intervention required" has been "Operator-intervention required". Follow
communicate with entered due to this reason. the instructions shown on the screen.
wet section
1181 A software or hard- Shown in the Activity Log when "Oper- The analyzer will automatically enter
ware error exists in ator-intervention required" has been "Operator-intervention required". Follow
wet section entered due to this reason. the instructions shown on the screen.
1183 Valve malfunc- Shown in the Activity Log when "Oper- The analyzer will automatically enter
tioning ator-intervention required" has been "Operator-intervention required". Follow
1184 Leak detected Shown in the Activity Log when "Oper- The analyzer will automatically enter
1185 Warning: Free The internal memory is low. - Restart the analyzer
memory is low
1186 Free system The internal memory is critically low. - Restart the analyzer
memory is critically
low
1187 Disk shows signs of The permanent memory is showing - Contact Radiometer service represen-
wear exhaustion signs and should probably be tative.
replaced soon.
1188 Disk shows serious The permanent memory is showing - Contact Radiometer service represen-
signs of wear exhaustion signs and should be replaced tative.
soon.
1189 FTC aborted, LS Shown in the Activity Log when "Oper- The analyzer will automatically enter
state change error ator-intervention required" has been "Operator-intervention required". Follow
1190 Inlet open Shown in the Activity Log when "Oper- The analyzer will automatically enter
1191 QA Portal commu- Shown in the Activity Log after enabling No action required. For information only.
nication enabled QA Portal communication
122
1192 QA Portal commu- Shown in the Activity Log after disabling No action required. For information only.
nication disabled QA Portal communication
1193 QA Portal output Shown in the Activity Log when the QA No action required. For information only.
queue cleared Portal has been reset.
1194 ABL not connected The analyzer is not connected to the QA - Contact your IT engineer.
to QA Portal Portal.
- Check QA Portal Communication Setup,
including TCP/IP address, port no. and
password.
- Check that QA Portal is responding.
- Check network connections.
1195 ABL not connected The analyzer was refused connection to Enter the correct password in the
to QA Portal - the QA Portal due to incorrect password. analyzer's QA Portal Communication
incorrect password Setup.
1196 ABL connected to The analyzer is connected to the QA No action required. For information only.
QA Portal Portal.
1197 ABL disconnected The analyzer is disconnected from the No action required. For information only.
form QA Portal QA Portal.
1198 ABL<>QA Portal Communication error between the Contact IT engineer or Radiometer
communication analyzer and the QA Portal. service representative.
error - XML packet
could not be
parsed
1199 FTC program has This message is found in the Activity Log No action required. For information only.
been retried when a measurement or calibration
activity has been retried due to error.
1201 Solution pack life- Shown in the Activity Log when "Oper- The analyzer will automatically enter
time expired ator-intervention required" has been "Operator-intervention required". Follow
1202 Expiration date Shown in the Activity Log when "Oper- The analyzer will automatically enter
reached ator-intervention required" has been "Operator-intervention required". Follow
1203 Lifetime in analyzer Shown in the Activity Log when "Oper- The analyzer will automatically enter
exceeded ator-intervention required" has been "Operator-intervention required". Follow
1204 No more activities Shown in the Activity Log when "Oper- The analyzer will automatically enter
left ator-intervention required" has been "Operator-intervention required". Follow
1216 Lifetime in analyzer Shown in the Activity Log when "Oper- The analyzer will automatically enter
exceeded ator-intervention required" has been "Operator-intervention required". Follow
1217 No more tests left Shown in the Activity Log when "Oper- The analyzer will automatically enter
123
1218 Expiration date Shown in the Activity Log when "Oper- The analyzer will automatically enter
reached ator-intervention required" has been "Operator-intervention required". Follow
1219 RiLiBÄK Violation: The measured value lies above the No action required.
Value above upper upper RiliBÄK range.
limit
1220 RiLiBÄK Violation: The measured value lies below the lower No action required.
Value below lower RiliBÄK range.
limit
1221 System tempera- Hardware temperature error (all). - Ensure that the ambient temperature is
ture out of range between 15 and 32 °C.



tative.
1222 Temperature Hardware temperature error - Ensure that the ambient temperature is
system error (Top/bottom termistor). between 15 and 32 °C.



tative.
1223 Analyzer did not The analyzer DMS has not been able to - Restart the analyzer.
connect at start-up establish contact to the WS(M) at
start-up. - Contact Radiometer service represen-
tative.
1224 Analyzer is tempo- Shown in the Activity Log after tempo- No action required.
rarily shut down rary shutdown of the analyzer.
1225 The sample is older The time between sampler draw time Either sampler draw time has been
than a day and aspiration is larger than 1 day. entered incorrectly or time of the
analyzer is incorrect. Change either to
correct the error.
1226 The sample age is The time between sampler draw time Either sampler draw time has been
negative and aspiration is less than zero. entered incorrectly or time of the
analyzer is incorrect. Change either to
correct the error.
1227 Correction for Chloride is corrected for bicarbonate, No action required.

bicarbonate calculated from pH and pCO2. Errors
contains errors from pH, pCO2 results in this error on
from pH, pCO2 chloride.
1228 Correction for Lactate is corrected for ion strength, No action required.
lactate contains calculated from K+, Na+, Ca2+. Errors
errors from K+, from K+, Na+, Ca2+ results in this error
Na+, Ca2+ on lactate.
1230 Inlet Gasket Holder Shown in the activity log at the time of a No action required.
replaced replacement.
124
1231 Inlet probe Shown in the activity log at the time of a No action required.
replaced replacement.
1232 Inlet Connector Shown in the activity log at the time of a No action required.
Gasket replaced replacement.
1233 Inlet cleaned Shown in the activity log at the time No action required.
when an inlet cleaning was performed.
1234 Demonstration Demonstration software - not for clinical No action required.

software - not for purposes
clinical purposes
1235 Failed to aspirate Aspiration failed Remove sampler. Retry aspiration

sample
1236 Failed to aspirate Aspiration failed, due to blocked inlet Remove sampler. Retry aspiration
sample
1240 Liquid transport Unstable aspiration from solution pack No action required
failed
failed
failed
failed
failed
failed
failed
failed
failed
failed
1253 Failed to aspirate Aspiration failed sample not detected Retry aspiration
sample
sample
failed
failed
failed
125
failed
failed
failed
failed
failed
failed
failed
failed
failed
sample
sample
failed
failed
failed
failed
failed
failed
failed
failed
failed
failed
failed
126
failed
failed
1295 Activity has been This message is shown in the activity log No action required.
repeated due to when an activity is repeated automati-
the following cally. It lists the error and parameter id
reason: that was the cause of the repeat.
1296 Printer out of paper The printer is out of paper. A new paper - Insert a new paper roll
roll must be inserted
1297 Printer is offline The printer is offline due to either a bad - Check the power connection
or missing power / USB connection
- Check the USB connection

tative.
1298 Printer lid open The printer lid is open - Close the printer lid
1299 Rinse activity A rinse activity has been repeated. The No action required.
repeated: following entries in the log explains the
reason for the repeat.
1300 Calibration activity A calibration activity has been repeated. No action required.
repeated: The following entries in the log explains
the reason for the repeat.
1301 QC activity A QC activity has been repeated. The No action required.

repeated: following entries in the log explains the
1302 Startup actvity A startup activity has been repeated. No action required.
repeated: The following entries in the log explains
1303 Actvity repeated: An activity has been repeated. The No action required.
following entries in the log explains the
1304 Calibration activity A calibration activity has been repeated. No action required.
repeated The following entries in the log explains
1305 End of repeat This message indicates the end of repeat No action required.
reason list reasons. See errors 1299-1304.
manualy removed ator-intervention required" has been "Operator-intervention required". Follow
1307 Disk space less The disk space on the analyzer is low. Delete some archives to free up space
than fifteen percent on the drive.
1308 Disk space less The disk space on the analyzer is less Contact service technician
than one percent than 1 %
1309 Unable to start FTC Unable to start FTC activity Contact service technician
activity - FTC
activity in progress
1310 Response error Sensor (Metabolit) does not work prop- Replace sensor
erly
127
1311 The analyzer chip It's not possible to read or write data to Contact Radiometer service representa-
data could not be the analyzer chip tive.
read or written
1312 Export data logs The export data log operation has failed. - Make sure the selected export path
failed exists.
- Make sure enough space is available.
1313 Export data logs The export data log operation has No action required.
done completed succesfully.
1314 Sensor tempera- Sensor temperature error (substrate) - Check sensor status and replace, if
ture error during during rinse necessary.
rinse
1315 Cal backlog error Cal backlog error (pH), leaping signals Perform rinse
(pH) on rinse
1316 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(pCO2) rinse
(pO2) rinse
(K) rinse
(Na) rinse
(Ca) rinse
(Cl) rinse
(Glu) rinse
(Lac) rinse
rinse solution (LS ator-intervention required" has been "Operator-intervention required". Follow
sensors) entered due to this reason. the instructions shown on the screen.
1325 Sensor thermistor Show in activity log when a recalibration Information only
recalibrated of the sensor thermistor has been
performed
1326 Sensor thermistor Shown in the Activity Log when "Oper- The analyzer will automatically enter
recalibration ator-intervention required" has been "Operator-intervention required". Follow
failed - thermistor entered due to this reason. the instructions shown on the screen.
mal-functioning
1327 Analyzer locked by Operator has locked the analyzer No action required.
operator
1328 Analyzer locked on The analyzer was locked on request from No action required.
request from LIS LIS
1329 Analyzer locked on The analyzer was locked on request from No action required.
request from Radiance
Radiance
128
1330 pO2 substrate The tickness of the pO2 sunstrate is -Perform calibration -Replace sensor
thickness outside the ranges cassette
1331 Intervention The analyzer enters UIR No action required.

required entered
1332 Intervention The analyzer exits UIR No action required.

required exited
1335 Solution pack This message is used in the Activity log No action required
replaced to indicate replacement of solution pack
1336 Sensor cassette This message is used in the Activity log No action required
replaced to indicate replacement of sensor
cassette
1337 Printer paper This message is used in the Activity log No action required
replaced to indicate replacement of printer paper
1338 Demo mode This message is used in the Activity log No action required
enabled to indicate that ABL 90 demo mode has
been enabled
1339 Demo mode disa- This message is used in the Activity log No action required
bled to indicate that ABL 90 demo mode has
been disabled
maintenance by to indicate startup using a sensor
Analyzer has been cassette which has been left without an
interrupted FTC activity for more than 2 hour.
1343 Unable to pump Shown in the Activity Log when "Oper- The analyzer will automatically enter
solutions ator-intervention required" has been "Operator-intervention required". Follow
removed to indicate replacement of solution pack
inserted to indicate replacement of solution pack
removed to indicate replacement of sensor
cassette
inserted to indicate replacement of sensor
cassette
1348 Warning - Battery This message is used in the Activity log Plug analyzer into mains
low to indicate low battery level
1349 Analyzer shutdown Analyzer shutdown due to low battery No action required
due to low battery
129
1350 Clot suspected in Clot suspected in Inlet No action required

Inlet
1351 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette
1352 Clot suspected in Clot suspected in OXI module No action required

OXI module
1353 Operator Action The analyzer has entered Operator Operator should perform action shown
Needed entered Action Needed on screen
1354 Operator Action The analyzer has exited Operator Action No action required
Needed exited Needed
1355 Conditioned Sensor Conditiones for performing a conditioned No action required

Startup sensor startup was fullfilled. The
analyzer does not initially perform cali-
bration with every measurement.
1356 Non-Conditioned Conditiones for performing a conditioned No action required

Sensor Startup sensor startup was fullfilled. The
analyzer does not initially perform cali-
bration with every measurement.
1357 Software upgrade This message is shown in the activity log No action required
initiated when a software upgrade has been initi-
ated
1358 Upgraded from This message is shown in the activity log No action required
when a software upgrade has been
performed
1359 Upgrade option: This message is shown in the activity log No action required
when a software upgrade has been
performed
1360 No clots detected This message is shown in the activity log No actions
in Analyzer when the clot detection program did not
detect any clots
1361 Internal reference The reference electrode is malfunc- Replace sensor cassette
electrode error in tioning.
sensor cassette
1362 Inlet gasket Guided troubleshooting step has been No action required
cleaning has been started by operator
started
1363 Inlet gasket Guided troubleshooting step has been No action required
cleaning has been skipped by operator
skipped
1364 Inlet gasket Test after action by operator is ok No action required

cleaning test ok
1365 Inlet gasket Test after action by operator has failed No action required
cleaning test failed
1366 Inlet gasket holder Guided troubleshooting step has been No action required
replacement has started by operator
been started
130
1367 Inlet gasket holder Guided troubleshooting step has been No action required
replacement has skipped by operator
been skipped
1369 Inlet gasket holder Test after action by operator has failed No action required
replacement test
failed
1371 Solution pack Guided troubleshooting step has been No action required
replacement skipped by operator
skipped
1372 Solution pack Test after action by operator is ok No action required

replacement test
ok
1373 Solution pack Test after action by operator has failed No action required
replacement test
failed
1374 Inlet connector Guided troubleshooting step has been No action required
gasket replacement started by operator
started
1375 Inlet connector Guided troubleshooting step has been No action required
gasket replacement skipped by operator
skipped
1376 Inlet connector Test after action by operator is ok No action required

gasket replacement
test ok
1377 Inlet connector Test after action by operator has failed No action required
gasket replacement
test failed
1378 Inlet gasket holder Test after action by operator is ok No action required
replacement test
ok
1379 Solution pack Guided troubleshooting step has been No action required
replacement started by operator
started
1380 Manual flush Guided troubleshooting step has been No action required
started started by operator
1381 Manual flush Guided troubleshooting step has been No action required
skipped skipped by operator
1382 Manual flush test Test after manual flush is ok No action required
ok
1383 Manual flush test Test after manual flush has failed No action required
failed
1384 Replace inlet The inlet gasket holder needs to be Replace inlet gasket holder
gasket holder replaced.
1386 System time No action No action

adjusted more than
2 hours
1387 Glu not usable pO2 too low for reliable cGlucose meas- N/A
urement
131
1388 Low Wi-Fi signal Low Wi-Fi signal quality detected No action required.
quality
1389 Unsupported Wi-Fi Wi-Fi USB adapter and/or configuration No action required.
configuration not supported
1390 Inlet cannot be The inlet cannot be closed - Remove any blocking items
closed
tative
1391 Inlet is not in the The inlet is not in the correct position - Contact Radiometer service represen-
correct position tative
1392 Remove sampling The inlet cannot be closed before the - Remove sampling device
device sampling device is removed
tative
1393 Inlet is not The analyzer has no inlet module - Install the inlet module
mounted installed
tative
1394 Calibration of the The analyzer could not calibrate the inlet - Contact Radiometer service represen-
inlet failed tative
1396 Sensor cassette Sensor cassette replacement is recom- Replace sensor cassette
replacement is mended
recommended
1397 Solution pack Solution pack replacement recom- Replace solution pack
replacement mended
recommended
1398 Recommended Recommended action removed. Just info No action needed

action removed
1399 Inlet Cover is Inlet Cover attached No action just info

attached
1400 Inlet Cover is Inlet Cover removed No action just info

removed
1401 Inlet Gasket Holder Inlet Gasket Holder did not return to Remove/replace the Inlet Gasket Holder
error expexted position after aspiration
1402 pO2 too low. cGlu- At pO2 levels <25 mmHg, glucose line- When a sample has low pO2 levels and
cose Linearity out arity is out of range at high glucose cGlu is required, repeat the measure-
of range. concentrations ment with an arterial sample
1403 Run Ampoule-based QC measurements must Do ampoule-based QC measurements

ampoule-based QC be done after Solution Pack replace-
measurements ments
1404 Run Ampoule-based QC measurements must Do ampoule-based QC measurements

ampoule-based QC be done after Sensor Cassette replace-
measurements ments
1405 Inconsistent data- QC lot numbers in the database do not Do the Solution Pack replacement proce-
base match those read from the smart chip in dure again with the same Solution Pack.
the Solution Pack Restart the analyzer.
1406 The analyzer is not The analyzer is not on a horizontal Put the analyzer on a horizontal surface
horizontal surface
132

sensor cassette

sensor cassette

sensor cassette

sensor cassette

sensor cassette

sensor cassette

sensor cassette

sensor cassette

sensor cassette

sensor cassette
- Replace the Solution Pack.
gas ator-intervention required" has been "Operator-intervention required". Follow
1544 Inhomogeneous air Shown in the Activity Log when "Oper- The analyzer will automatically enter
133
Activity log
About the Activity log
The Activity log is where activities done on or by the analyzer are saved.
To troubleshoot messages in the Activity log

1. Tap Menu > Data logs > Activity log.
To see activities in the Activity log

To add a message to the Activity log

2. Tap the Add message button.
3. Enter the message.
To filter activities from the Activity log

Option Steps
fields
5. If necessary, do step 4 again.
Analyzer service
For service
For service, contact your local Radiometer representative. You may have to supply the
installation number (serial number) of the analyzer and the version number of the
installed software.
134
To find the installation number (serial number) of the analyzer

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Analyzer ID.
2. Read the installation number (serial number) on the screen.
Note: The installation number can also be found on printouts of QC, Calibration
and Patient results and on printouts from data logs.
To find the version of software installed

2. Read the software version in the lower left corner of the screen.
135
136
Shutting down, moving and
restarting the analyzer 8
Shutdown
Shutdown is a safe procedure for you to close down the analyzer. There are 2 proce-
dures a Temporary shutdown and a Long term shutdown.
Note: Do not use the power switch to shut down the analyzer.
Temporary shutdown of the analyzer
When to do a temporary shutdown
Usually, the analyzer is kept switched on so that it is ready to use at any time.
However, in some situations, it is necessary to do a temporary shutdown:
• When an analyzer without a battery must be moved to a new location
• When an analyzer with a low-charge level battery must be moved to a new location
• When the analyzer tells you to do a shutdown (for example, during a trouble-
shooting procedure)
• After a non-USB keyboard or mouse is connected to an analyzer that is switched on.
Note: If the analyzer is shut down for more than 2 hours, the Sensor Cassette must be
replaced.
To do a temporary shutdown
1. Tap Menu > Utilities > Temporary shutdown.

2. Tap the Confirm shutdown button.
3. Wait until the Windows program tells you that it is shutting down.
4. When Windows program has shut down, push the analyzer power switch to the Off
position (O).
Long-term shutdown of the analyzer
When to do a long-term shutdown
It is usually only necessary to do a long-term shutdown when the analyzer is stored.
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Chapter 8: Shutting down, moving and restarting the ABL90 FLEX: Instructions for use
analyzer
To do a long-term shutdown
Prerequisites:
• The Inlet Module has been cleaned
• A syringe filled with S5362 Hypochlorite Solution
• A syringe filled with distilled water
Note: Approximately 15 minutes are necessary for this procedure.
Note: The Sensor Cassette used during this procedure must not be used again.
1. Tap Menu > Utilities > Long term shutdown.

3. Hold the syringe with the S5362 Hypochlorite Solution by its barrel.

6. Place and hold the tip of the syringe in the center of the inlet gasket.
7. Push the syringe into the analyzer as far as it will go and hold it there.
Note: Be careful not to bend the Inlet Probe.
8. Hold the syringe in the pushed-in position until the analyzer tells you that the aspi-
ration is completed.
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ABL90 FLEX: Instructions for use Chapter 8: Shutting down, moving and restarting the
analyzer
9. When the analyzer tells you that the aspiration is completed, remove the syringe.
11. Hold the syringe with distilled water by its barrel.
12. When the analyzer tells you to, do steps 6 to 10 again.
13. Wait until the Sensor Cassette compartment opens.
14. Remove the Sensor Cassette and dispose of it as biohazardous waste.
15. Tap the Confirm removal button.

16. When the analyzer tells you to, lift the inlet handle to the capillary position.
17. Wait until the Solution Pack is ejected.

18. Remove the Solution Pack and dispose of it as biohazardous waste.

20. Wait until the Windows program tells you that it is shutting down.
21. When the Windows program has shut down, push the analyzer power switch to the
Off position (O).
Related information
Can a Solution Pack be used again?, page 38
139
analyzer
Storing the analyzer
To store the analyzer

1. Do a long-term shutdown.
2. Put a dustcover on the analyzer.
3. Store the analyzer between -20 °C and 60 °C.
Moving the analyzer
To move an analyzer that has a charged battery
Note: The charge level of the battery must be high enough to be able to move the
analyzer and connect it to the mains power supply before the charge level drops below
11 %.
1. Disconnect the power cable and peripheral devices.

2. Lift the analyzer by its handle, keep it vertical and move it to its new location.
3. Connect the power cable and peripheral devices to the analyzer.
4. Connect the analyzer to the mains power supply before the analyzer battery
charge-level falls below 10 %.
To move an analyzer that does not have a battery

1. Do a temporary shutdown.
2. Disconnect the power cable and peripheral devices.
3. Lift the analyzer by its handle, keep it vertical and move it to its new location.
4. Connect the power cable and peripheral devices.
5. Switch on the mains power supply.
6. Push the power switch to the On position (I).
7. If the analyzer does not restart, press the standby button on the back of the
analyzer.
Restarting the analyzer
To restart the analyzer after a temporary shutdown

1. Push the power switch to the On position (I).
analyzer
Note: The analyzer is ready for use when it is Ready.
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ABL90 FLEX: Instructions for use Chapter 8: Shutting down, moving and restarting the
analyzer
To restart the analyzer after a long-term shutdown
Prerequisites:
A Solution Pack A Sensor Cassette
1. Use the power cable to connect the analyzer to the mains power supply.
2. Push the power switch to the On position (I) and wait until the Operator-inter-
vention required screen is shown.
analyzer.
4. Install a Solution Pack.
5. Install a Sensor Cassette.
The analyzer is ready for use when it is Ready.
141
analyzer
142
Setup 9
Setup menu structure
Menu
Utilities
Setup Syringe modes

Capillary modes
Patient reports
Analysis setup Reference ranges
Sample age evaluation setup
Reportable ranges
Sample pre-registration
QC solutions
QC schedule
QC ranges
QC setup QC input setup
QC statistics
Westgard Rules
RiLiBÄK ranges
Calibration schedule
Replacement schedule
Operator activities
Replacement setup
Maintenance planning
Replacement warnings
Analyzer ID
Time / Date
Analyzer settings Acoustic signal
Barometer
Language
Parameters
Units
Parameters and input
User-defined data items
User-defined notes
RADIANCE / AQURE connection
LIS/HIS connection
Automatic data transmission
General setup Communications Automatic data request
Patient lookup setup
Remote support
QA Portal connection
Automatic archiving
Disk functions setup
Automatic backup
Printer setup
Printers
Automatic printing
Corrective actions
Miscellaneous setup
General security
Analyzer security Operators and passwords
Access profiles
Print analyzer setup
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Chapter 9: Setup ABL90 FLEX: Instructions for use
To print setups
1. Tap Menu > Utilities > Setup > Print analyzer setup.
2. Deselect the check buttons for the setups you do not want to print.
3. Tap the Print button.
4. If necessary, select the printer and tap the Select printer button.
Managing operators
To select the logon procedure

1. Tap Menu > Utilities > Setup > Analyzer security > General security.
2. In the Authenticate operator by field, select the option you want.
Option Action
To let most operators log on with an Operator Select “Operator ID / pass-

name: and Password:, but let some operators word as primary”
log on with a logon barcode
To let most operators log on with a logon barcode, Select “Logon-barcode as

but let some operators log on with an Operator primary”
name: and Password:
To only let operators log on with an Operator Select “Operator ID / pass-

name: and Password: word only”
To only let operators log on with a logon barcode Select “Logon-barcode only”
Access profiles
An access profile specifies what an operator with the given profile can do on the
analyzer.
• The operations that can be done
• The menus and screens that can be opened
• The shortcut buttons that are available to operators
Eight access profiles are available. Access profiles may be edited, but their names
cannot be changed. No new access profiles can be created. An access profile must be
selected for each operator.
To edit an access profile
Note: All access profiles may be edited, but some only in part.
1. Tap Menu > Utilities > Setup > Analyzer security > Access profiles.
2. Select the access profile.
3. Select the check buttons in the Permitted actions for selected profile field.
4. Tap the Menu and buttons for selected profile button.
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ABL90 FLEX: Instructions for use Chapter 9: Setup
5. To create a shortcut button.

Note: You can create a shortcut button to six menus.
a) In the Available menu items: field, select the menu you want a shortcut
button for.
b) In the Button shortcuts field, select a button position for the shortcut.
c) Do these steps again for each shortcut button you want to create.
6. To create access to menus.
a) In the Available menu items: field, select the menu that you want to
create access to.
b) Tap the Select / Deselect button.
Note: Make sure a checkmark is shown in the selected check box.
c) Do these steps again for each menu you want to create access to.
Anonymous use
Operators do not have to log on to an analyzer that is set up for anonymous use. The
access profile selected for anonymous use specifies the shortcut buttons and menus
that anonymous operators can use.
To set up anonymous use

2. Select the Allow anonymous use check button.
3. Select an access profile for anonymous operators.
Default operators
Some operators are set up by default.
Operator Default access to menus Can the oper-

ator be
deleted?
Manager See the default “Manager” access profile. Yes

Note: The password 123456 lets you log on to the analyzer
the first time the analyzer is used.
Radiometer All operator and service menus. No
Remote operator All operator and service menus. No
Note: A remote operator cannot by default view patient

data.
Note: This operator is only shown when you have the

“Remote support” option. Contact your local Radiometer
representative for details.
To add an operator
1. Tap Menu > Utilities > Setup > Analyzer security > Operators and pass-
words.
2. Tap the Add operator button.
145

Option Steps
To let the oper- a) Enter a unique ID for the operator.

ator log on with
an Operator Note: Only enter 35 characters, so that the complete ID is
name: and a seen in the Logon screen.
Password:
Note: Do not include characters such as apostrophes (')
and slashes (/).
b) Enter the password for the operator.
Note: The password must contain a minimum of 4 charac-
ters.
c) Enter the password again in the Confirm: field below the
Password: field.
To let the oper- a) Enter or scan in the logon barcode for the operator.
ator log on with
a logon barcode Note: The logon barcode must be unique and contain a
minimum of 4 characters.
b) Enter or scan in the logon barcode again in the Confirm
field below the Logon - barcode: field.
To let the oper- a) Enter a unique ID for the operator.

ator log on with
an Operator Note: Do not include characters such as apostrophes (')
name: and a and slashes (/).
Password: or
with a logon Note: Only enter 35 characters, so that the complete ID is
barcode seen in the Logon screen.
b) Enter the password for the operator.
Note: The password must contain a minimum of 4 charac-
ters.
c) Enter or scan in the password again in the Confirm: field
below the Password: field.
d) Enter or scan in the logon barcode for the operator.
Note: The logon barcode must be unique and contain a
minimum of 4 characters.
e) Enter or scan in the logon barcode again in the Confirm
field below the Logon - barcode field.
Note: If data is not valid, a pop-up message is shown and an acoustic signal is
sent.
5. Make sure that the operator is selected.
6. Select an access profile for the selected operator.
To remove an operator
1. Tap Menu > Setup > Analyzer security > Operators and passwords.
2. Select the operator.
3. Tap the Remove operator button.
146
To set a logoff time for all operators
Note: If no time is set, operators will be automatically logged off after 3 minutes. The
maximum logoff time that can be set is 60 minutes and 50 seconds.
1. Tap Menu > Utilities > Setup > Analyzer security > General Security.
2. Tap the Log off time button.
3. Set a logoff time in minutes and seconds.
Centralized user management
Centralized user management lets a connected AQURE/RADIANCE system do some of

the management procedures usually done on the analyzer. The table shows which
procedures will have to be done on the connected AQURE/RADIANCE system if central-
ized user management is set up.
Procedures Done on the Done on the analyzer*

AQURE/RADIANCE system
Add new operator X
Select an access profile for a X

new operator
Remove operators X
Select the logon procedure X
Set up anonymous use of the X

analyzer
Edit an access profile X
Set the logoff time for all oper- X

ators
* These procedures can also be done remotely from a connected AQURE/RADIANCE

system.
To set up centralized user management
Note: We recommend that you use the same set of rules to add analyzer operators to
the AQURE/RADIANCE system as you use to add operators to the analyzer. If central-
ized user management is then disabled, operators can continue to log on.
1. In the connected AQURE/RADIANCE system, add present operators of the analyzer

as present operators in the AQURE/RADIANCE system.
Note: This is important because when centralized user management is set up, all
operator data in the analyzer is overwritten by data received from the
AQURE/RADIANCE system. Only present operators in the AQURE/RADIANCE
system can log on to the analyzer.
3. Select the Enable centralized user management check button.
4. Select the Close button.
Note: This will have no effect on the activities in progress.
147
Managing patient profiles
Patient profiles log
A patient profile contains data that helps to identify a patient. This data is automati-
cally saved in the Patient profiles log during sample analysis.
If a Patient ID is included in a profile, the analyzer will download all the other patient
profile data to the Patient identification screen, when the Patient ID field is filled
in. If the analyzer is set up to automatically request patient data from a LIS/HIS
system, data received from the LIS/HIS system updates data in the screen and in the
log.
To see the data saved in a patient profile

1. Tap Menu > Data logs > Patient profiles log
2. Select the patient.
3. Tap the Edit button.
To find a patient profile

1. Tap Menu > Data logs > Patient profiles log.
2. Tap the Find button.
3. Select the field of the criterion you want to use to find the patient profile. For
example Patient ID.
4. Enter data in the field.
5. Tap the Find button.
To edit a patient profile

2. Select the patient profile.
4. Edit the values you want to edit.
To add a new patient profile

2. Tap the Add button.
3. Enter data in the Patient ID field.
4. Enter data in other fields that help to identify the patient.
To delete a patient profile

2. Select the patient profile.
3. Tap the Delete button.
148
Analyzer operations
To lock the analyzer
No samples can be analyzed when the analyzer is locked. However, the analyzer will
continue to do automatic calibrations.
2. Select the Analyzer locked check button.
To unlock the analyzer
This procedure lets you unlock the analyzer when an operator has locked it.
Note: To unlock an analyzer that is set up to lock automatically after a Solution Pack
and/or Sensor Cassette replacement: Operators must do the requested ampoule-based
QC measurements.
2. Deselect the Analyzer locked check button.
To lock/unlock parameters for measurement
A locked parameter cannot be measured. When a parameter is locked, the parameter

tab changes to red and no values are given for the parameter in result screens or in
printouts. However, locked parameters continue to be calibrated.
1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
Parameters.
3. Tap the Lock/ Unlock button.
Note: The last value in the Enabled/locked column must be “Yes” to lock the
parameter, and “No” to unlock it.
To show a message on the analyzer screen
The message is shown in the start screen.
2. Enter a message in the Analyzer message frame.
149
Sample counter
To see an overview of measurements and tests done on the analyzer

1. Menu > Utilities > Sample counter.
Sample counter
The Sample counter screen gives an overview of the measurements and tests done
on the analyzer.
Data Description
Parameter, Count Shows the number of tests done for each parameter on patient samples
and QC solutions
Total column Shows the number of completed patient sample analyses, calibrations and
QC measurements.
Note: Because a parameter can be removed from a measurement, the
total number of completed measurements may not be equal to the total
number of tests.
Aborted column Shows the number of measurements stopped by the analyzer because it
found an error
User column The number of measurements done since the user counters were last set
to zero
User counters last Shows the date when the counters in the User column were last reset to
reset zero
To reset the counters in the User column
Note: The counter in the User column is the only counter that can be reset (set to
zero).
1. Tap the Menu > Utilities > Sample counter.

2. Tap the Reset counters button.
Analyzer settings
To set up corrective actions on system messages
Two corrective actions are available for system messages.
150
• Select the color of traffic light shown on the left side of the System messages
button in the Analyzer status screen
• Attach a message about the system message to the next patient result
1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select the condition “System message(s) present”.
Option Steps
To change the traffic light color a) Tap the traffic light until it shows the color
you want.
To attach a message to the a) Select the Message on next patient result

next patient result check button.
To enable data to be scanned from barcodes
This procedure lets operators scan barcodes to enter data into more text fields than
the Patient ID, Accession no. and Sampler ID text fields.
2. Select the Enable general barcode support check button.
To create a heading for printed data
Note: The text you enter in this procedure will be part of the heading that will be
shown on all printed data and data sent to LIS/HIS and AQURE/RADIANCE systems.
The Analyzer type: will also be included.
Analyzer ID.
2. Enter the text for the heading (up to 25 characters). For example, a hospital or
department name.
To enable the screen saver

2. Select the Enable screen saver check button.
3. In the Screen saver frame, select the number of minutes the analyzer must not
be in use before the screen saver is shown.
To set the time and date
This procedure sets the time and date on the analyzer clock. The time at which meas-
urements and activities are done are read from this clock. If there is more than 2 hours
151
difference between the time you set and the system time, the activity is recorded in
the Activity log.
1. Tap Menu > Utilities > Setup > General setup > Analyzer settings > Time /
Date.
2. Enter the time.
Note: The Current button cancels entered values.
3. Enter the date.
Note: The Current button cancels entered values.
To set the acoustic signals

Acoustic signal.
2. Select when you want an acoustic signal to be given.
3. Use the scroll buttons to select the volume level.
To mute all acoustic signals

Acoustic signal.
2. Select the Mute all acoustic signals check button.
To change the screen language

Language.
2. In the Select a language from the list frame, select a language.
3. Tap the Set language button.
4. Tap the Continue button.
5. Choose an option and follow the steps for it:
Option Steps
To change the language immediately Tap the Continue button.

Note: This will restart the analyzer.
To change the language later. For a) Tap the Cancel button.

example, if you also want to change b) Restart the analyzer later.
regional settings.
To select a regional setting
A regional setting includes default values for time and date formats, the separator used
for thousands and decimals in numerical values and the layout of the keyboard shown
on the analyzer screen.
Language.
2. In the Regional settings frame, select a regional setting.
152
3. Tap the Set regional settings button.

Note: This will restart the analyzer.
To set the barometric pressure
Prerequisite: The value of the barometric pressure in your laboratory.
This procedure makes sure that the analyzer barometer values are adjusted to the
room in which the analyzer is used.
Barometer.
2. In the Adjust to: field, enter the value of the barometric pressure in your labora-
tory.
Note: The maximum difference between the Measured unadjusted: and Adjust
to: values that the analyzer will accept is ±19 mmHg.
Related information
Environmental specifications, page 378
To log all measurement activities
By default not all measurement activities are recorded in the Activity log. This proce-
dure sets up the analyzer to record all measurement activities.
1. Tap Menu > Utilities > Setup > General setup > Miscelleneous setup.
2. Select the Log all measurement activities check button.
Analysis setup
Analysis modes
Syringe modes
Syringe modes refer to the types of analysis that can be done when the inlet is in the
syringe position. The syringe mode, Syringe - S 65µL is setup by default for the anal-
ysis of patient samples in syringes. This mode can be edited and new syringe modes
created.
Bilirubin can only be measured on neonatal samples. This parameter is only available in
the Neonate blood analysis 65 μL mode.
To edit a syringe mode

1. Tap Menu > Utilities > Setup > Analysis setup > Syringe modes.
2. Tap the button for the mode you want to edit in the Primary modes or Secon-
dary modes field.
Note: The set of modes that holds the default mode is the one first shown during
a measurement.
153
3. Tap the Edit name button.

4. If necessary, edit the name.
Note: The text – S 65µL cannot be changed.
5. Tap the Parameters button.
6. If necessary, choose another option and follow the steps for it.
Option Steps
To set up a default parameter profile for Select the parameters to measure in

the mode the mode.
To let operators select the parameters Select the Select parameter profile
they want to show in patient results during measurement check button.
To set up a default parameter profile for • Select the parameters to measure in

the mode, but also let operators select the mode.
the parameters they want to show in
• Select the Select parameter
patient results
profile during measurement
check button.
7. Make sure the check buttons for parameters you want to measure in this mode are
selected.
9. Tap the Layout button.
10. If necessary, select another patient report layout to be shown when you measure
in this mode.
12. Tap the button for the mode you want to be the default mode.
Note: The default mode is the mode the analyzer will use if no other measurement
mode is selected.
To create a new syringe mode

2. Tap a button with no text in the Primary modes or Secondary modes field.
a measurement.
3. Select the Button is enabled: check button.
4. Tap the button until the Measuring program: field shows the mode you want.
6. Enter a name for the mode.
Note: The text – S 65µL cannot be changed.
154

Option Steps

the mode the mode.

patient results
check button.
selected.
in this mode.
A small black mark in the top right-hand corner of the button shows that the mode
has been selected as the default.
mode is selected.
To remove a measurement mode

2. Tap the button for the mode you want to remove.
3. Deselect the Button is enabled: check button.
To select a default measurement mode
The default measurement mode is the mode the analyzer will use if no other measure-
ment mode is selected.
155
To select a specific patient report layout for an analysis mode
Prerequisite: There is more than one patient report layout.
This procedure lets you select the patient report layout that the analyzer shows during
an analysis.

Option Steps
For analyses done with the inlet in the Tap Menu > Utilities > Setup > Anal-
syringe position ysis setup > Syringe modes.
For analyses done with the inlet in the Tap Menu > Utilities > Setup > Anal-
capillary position ysis setup > Capillary modes.
2. Tap the button for the mode in the Primary modes or Secondary modes field.
3. Make sure the Button is enabled: check button is selected.
5. Select the patient report layout to be automatically shown.
To set up a calibration-verification mode
It is necessary to set up a calibration-verification mode before calibration-verification

measurements can be done.
4. Tap the button until the button you selected in step 2 is given the name Cal．
Verification.
mode is selected.
To set up an ampoule QC mode
This is an optional procedure. It lets you start ampoule-based QC measurements from

the same screen as you start patient sample analyses.
4. Tap the button until the button you selected in step 2 is given the name
Ampoule - QC.
mode is selected.
156
Capillary modes
Capillary modes refer to the types of analysis that can be done when the inlet is in the
capillary position.
The capillary mode Capillary - C 65µL is set up by default for the analysis of patient
samples in capillary tubes. The mode can be edited.
To edit a capillary mode

1. Tap Menu > Utilities > Setup > Analysis setup > Capillary modes.
2. Tap the button for the mode you want to edit in the Primary modes or Secon-
dary modes field.
a measurement.
4. If necessary, edit the name.
Note: The text - C 65µL cannot be changed.
6. If necessary, choose another option and follow the steps for it.
Option Steps

the mode the mode.

patient results
check button.
selected.
in this mode.
mode is selected.
Proficiency test modes
Proficiency test is a process that lets you verify the performance of your analyzer with
accredited test solutions. Some local, state or federal regulations require proficiency
tests to be done.
To get the proficiency test mode shown in the measuring screen, you have to set up a
proficiency test mode.
157
To set up a proficiency test mode
It is necessary to set up a proficiency test mode before proficiency tests can be done.
4. Tap the button until the button you selected in step 2 is given the name Prof.
Test.
Note: Make sure a small black mark is shown in the top right-hand corner of the
button, as the mode is then set to be default.
10. Tap the button until the button you selected in step 2 is given the name Prof.
Test.
Note: Make sure a small black mark is shown in the top right-hand corner of the
button, as the mode is then set to be default.
Ranges and critical limits
About ranges and critical limits
Measurement results are marked by symbols to show where they fall in relation to
reference ranges, critical limits and reportable ranges. The diagram illustrates these
relationships.
1 Reference range 4 Reportable range
2 Lower critical limit 5 Range of indication
3 Upper critical limit
158
About reference ranges
A reference range is the range of test values expected for a healthy population of indi-
viduals or some other defined group. Patient results that lie outside the limits will be
marked with the symbols:
Reference ranges are valuable guidelines for the clinician, but they should not be
regarded as absolute indicators of health and disease. Reference ranges should be
used with caution since values for 'healthy individuals often overlap significantly with
values for persons afflicted with disease. In addition, laboratory values may vary
significantly due to methodological differences and mode of standardization [1].
Reference ranges are not set up by default. Laboratories must establish their own
ranges. If reference ranges are set up, patient results that lie outside the limits will be
marked with symbols.
Related information
Symbols on patient results, page 28
Reference range of measured parameters
The Radiometer publication Bulletin No: 44, Compendium of reference intervals

(product code 918-714) is available on request. Contact your local Radiometer repre-
sentative. Other documents about reference ranges/intervals can be accessed on the
www.acutecaretesting.org website.
Reference ranges for neonatal ctBil
the Neonate blood analysis 65 μL mode.
Age ctBil
≤24 hrs, premature 103-205 µmol/L
1.0-8.0 mg/dL
10-80 mg/L
≤24 hrs, full-term 34-103 µmol/L
2.0-6.0 mg/dL
20-60 mg/L
≤48 hrs, premature 103-205 µmol/L
6-12 mg/dL
60-120 mg/L
≤48 hrs, full-term 103-171 µmol/L
6-10 mg/dL
60-100 mg/L
3-5 days, premature 171-239 µmol/L
10-14 mg/dL
100-140 mg/L
159
3-5 days, full-term 68-137 µmol/L
4-8 mg/dL
40-80 mg/L
About critical limits
Critical limits are not set up be default. Laboratories must establish their own critical
limits. If critical limits are set up, patient results that lie outside the limits will be
marked with the symbols:
The symbols may be used to indicate when a value is dangerously high or low.
Related information
To set the limits for patient age groups
This procedure is necessary if the reference ranges are not the same for all age
groups.
Note: The age groups you set are for all parameters, they are not parameter-specific.
1. Tap Menu > Utilities > Setup > Analysis setup > Reference ranges.
2. Tap the Age groups button.
3. Use the left or right arrow buttons to select an age-limit field.
4. Select an age limit for the selected field.
5. Do steps 3 and 4 again to set the limits for each age group.
Note: The youngest age group always starts at zero years. The oldest age group
always starts at the highest selected age limit. For example, if the highest selected
age limit is 70 years, the oldest age group is from 70 to 70+ years.
To set up reference ranges and critical limits
Prerequisite: Patient age groups have been set
Laboratories should establish their own reference ranges.
1. Tap Menu > Utilities > Setup > Analysis setup > Reference ranges.
2. Select a parameter in the Parameter: field.
3. If the reference ranges of the selected parameter are dependent on a specific type
of patient sample, select the Sample type check button.
4. If the reference ranges of the selected parameter are dependent on the age of
patients, select the Age group check button.
5. If the reference ranges of the selected parameter are dependent on the sex of
patients, select the Sex check button.
6. Select a setting for each of the buttons selected in steps 3, 4 and 5.
8. Enter values for the reference range and the critical limits.
If an entered value is not accepted, it will be removed and a message will be
shown for a short period of time in a window on top of the screen.
10. Do steps 6 to 9 again for each of the combinations of sample type, age and/or sex.
160
11. Do steps 2 to 10 again for each parameter.

About reportable ranges
Reportable range is the range of results from a testing system or method over which
analytical performance is claimed.
Patient results that lie outside the limits will be marked with the symbols:
Related information
Ranges of indication and reportable ranges, page 371
About range of indication, page 161
To set up reportable ranges
Note: Symbols are shown on test results that fall outside the reportable range of the
measured parameter.
1. Tap Menu > Utilities > Setup > Analysis setup > Reportable ranges.
Option Steps
To set the reportable range of a) Tap the Set all default button.
all parameters to the default b) Tap the Continue button.
values
To set the reportable range for a) Select a parameter in the Parameters field.
a parameter to the default b) Tap the Set default button.
value
To set the reportable range for a) Select the parameter in the Parameters
a parameter field.
b) Enter new values for the upper and lower
limits of the reportable range.
About range of indication
Only results within the Reportable range should be reported
Sample pre-registration
About sample pre-registration
Sample pre-registration lets operators make sure that the patient data shown on the
screen belongs to the patient whose sample is to be analyzed. This reduces the risk of
patient/sample mix-up.
161
Note: The analyzer must be set up for sample pre-registration.
Related information
To set up sample pre-registration, page 162
To set up sample pre-registration

1. Tap Menu > Utilities > Setup > Analysis setup > Sample pre-registration.
2. Select a value in the Interpret barcode input as field.
3. Make sure that check buttons are selected for the data fields you want included in
the Patient identification screen shown during pre-registration.
Note: A data field is automatically included for the value you selected in step 2.
Sample age evaluation
About sample age evaluation
Sample age evaluation lets the analyzer calculate the age of patient samples and
compare it to the value set in the Sample age rule in minutes value. Samples older
than this value will be analyzed but a message attached to the patient result will indi-
cate that the sample was old.
The calculation is based on the sample Draw time entered on the Patient identifica-
tion screen:
[Sample age] = [Time the sample aspiration starts] - [Time the sample was collected].
Maximum sample age
Maximum sample age is the maximum period of time that should elapse between when
a sample is collected and when it is analyzed. How the sample is stored and handled
after it is collected has an effect on the maximum sample age.
Note: Maximum sample age is not the same as the Max sample age.
Related information
Storage recommendations, page 19
To set a maximum sample age
The Sample age rule in minutes value is set by default to the same value for all
parameters. However, a value can be set for each individual parameter.
Note: You must include the Sample age item in your patient report layouts to see
calculated values.
1. Tap Menu > Utilities > Setup > Analysis setup > Sample age evaluation
setup.
2. Select the Enable sample age evaluation check button.
162

Option Steps
To select the same • Select a maximum sample age for the parameter
maximum sample age for in the Sample age rule in minutes field.
all parameters
• Select the Same rule for all the parameters
check button.
To select a maximum • Select a parameter.

sample age for a param- • Select a maximum sample age for the parameter
eter
in the Sample age rule in minutes field.
Max sample age
Max sample age is a read-only field in the Patient identification screen. The value
shown in the field is the value entered by the RADIANCE system, which overwrites the
Sample age rule in minutes value set up on the analyzer.
Patient report layouts
About patient report layouts
A patient report layout has 2 parts:
• A patient ID part – lets you create the content and layout of the Patient identifi-
cation screen
• A patient results part – lets you create a template for the content and layout of the
Patient results screen
You can select a default patient report layout. The default report layout is the Report
layout shown in the Patient identification screen when it opens.
To create a patient report layout

1. Tap Menu > Utilities > Setup > Analysis setup > Patient reports.
2. Tap the New button.
3. Enter a name for the report in the Name: field.
4. Tap the Edit patient ID layout button.
5. To add data items to the layout:
a) Select a data item In the Available items frame.
b) Tap the right arrow button.
Note: Data items are shown in the layout as you add them.
c) Do steps a) and b) again for each data item you want to add.
Option Steps
If patient data is to be automatically Add the data item that was selected in the
requested from a LIS/HIS or Interpret barcode input as field during
AQURE/RADIANCE system the sample pre-registration setup procedure.
163
Option Steps
If patient data is to be manually requested Add the data field selected in the Request
from a LIS/HIS or AQURE/RADIANCE system patient demographics frame during the
automatic requests for patient data proce-
dure.
It will be one of the items: Sampler ID,

Patient ID or Accession no．
Note: If more than one of these items are

added, it is the item closest to the top of the
Patient identification screen that must be
filled before you can manually request
patient data from the LIS/HIS or
AQURE/RADIANCE system.
If patient data is to be looked up, found and Add the “Department (Pat.)” data item.
requested manually
If the analyzer is connected to a RADIANCE Add the Max sample age item.
system.
The value shown in this field will show the
value set in the RADIANCE system.
6. To make a data item mandatory:

a) Select the data item in the Selected items frame.
b) Tap the Set as mandatory button.
Note: The mandatory icon is shown adjacent to the data item.
7. To set a default value for a data item, choose an option and follow the steps for it.
Option Steps
To enter a value a) Select the data item in the Selected items frame.
b) Tap the Keyboard button.
c) Enter a value.
To select a value from a a) Select the data item in the Selected items frame.
data item list b) Tap the List button.
c) Select a value in the Available values field.
d) Tap the Select button.
9. Tap the Edit patient results layout button.
10. To add a heading for a group of parameters:
a) In the Available items frame, select a heading. For example, “Blood gas
values”.
11. To add a parameter:
a) In the Available items frame, select a parameter.
Note: Parameters will be shown in the results as they are shown in the
Selected items field.
c) If necessary, do steps a) and b) again.
12. To change the position of an item in the Selected items frame:
a) Select the item.
b) Tap the left arrow button.
c) In the Selected items frame, select the item you want the selected item to
follow.
In the Available items frame, select the item you selected in step a).
d) Tap the right arrow button.
164
13. To show the reference range of a parameter with patient results:

a) In the Selected items frame, select a parameter.
b) Tap the Show ranges button.
c) If necessary, do steps a) and b) again for other parameters.
14. To change the selected data items to the data items in the Radiometer default
report layout, tap the -R- Default button.
Related information
To select a patient report layout as default, page 166
To change a patient result layout
This procedure tells you how to change the patient result layout for a selected layout.
2. Select the layout.
values”.
a) Select the item.
follow.
165
To create extra items for use in patient report layouts

User-defined data items.
Option Steps
To create a text a) Tap the Add button.

item. b) Enter the name of the item.
Note: Only enter 20 characters, so that the complete
name is seen in the Patient Identification screen.
c) Select “Text” in the field on the right of the screen.
e) Tap the Back button.
To create a a) Tap the Add button.

numerical item. b) Enter the name of the item.
Note: Only enter 20 characters, so that the complete
name is seen in the Patient Identification screen.
c) Select “Numerical” in the field on the right of the screen.
e) Enter the name of the unit.
f) If entered numbers must have a fixed number of decimals
to be accepted, select the number of decimals. Tap the
Select button.
g) If entered numbers must fall within a range to be
accepted, enter the maximum and minimum values of the
range.
h) Tap the Back button.
To create a selec- a) Select the item.

tion list for an b) Tap the Edit button.
existing text or
numerical item. c) Tap the Use selection list check button.
d) Tap the Add button.
Note: A
minimum of 2 e) Enter a value.
values must be f) Do steps d) to e) again for each item you want in the
added to create a selection list.
list. g) Tap the Use selection list check button.
h) Tap the Back button.
3. Tap the Close buttons.
To select a patient report layout as default
The patient report layout you select as default is the one shown in the Patient identi-
fication screen when it opens.
3. Tap the Make default button.
166
To automatically change the temperature units
The analyzer can be set up to let temperatures (for example, patient temperatures) be
entered in Celcius (°C) or Fahrenheit (°F) degrees. However, this procedure lets the
analyzer automatically change the set up temperature unit from °F to °C if an operator
enters °C values in a °F temperature field and vice versa.
Examples: If 41 is entered as the patient temperature in a °F temperature field, the

analyzer will automatically change the unit to °C. If 105 is entered as the patient
temperature in a °C temperature field, the analyzer will automatically change the unit
to °F.
2. Select the Auto temp unit conversion check button.
To edit a patient report layout

4. To add an item to the layout:
a) Select an item In the Available items frame.
Note: Items are shown in the layout as you add them.
5. To remove an item from the layout:
a) Select an item In the Selected items frame.
6. To make an item mandatory:
a) Select the item in the Selected items frame.
b) Tap the Set as mandatory button.
7. To set a default value for an item:
a) Select the item in the Selected items frame.
b) Tap the Keyboard button and enter a value, or: (1) Tap the List button. (2)
Select a value. (3) Tap the Select button.
values”.
a) Select the item.
follow.
In the Available items frame, select the item you selected in step a).
167

15. If necessary, enter a new name for the report in the Name: field.
16. To change the selected data items to the data items in the Radiometer default
report layout, tap the -R- Default button.
̄
To create a patient report layout for FShunt and ctO2(a-v)
2. Select the -R- Default layout.
3. Tap the Copy button.
4. Enter a name for the report in the Name: field.
6. Select pO2(v)̄ in the Available items frame.
7. Tap the right arrow button.
8. Do steps 5 and 6 again for these parameters:
• sO2(v̄)
• FO2(I)
• RQ
• T
9. If necessary, select another patient identifier in the Available items frame.
11. Do steps 8 and 9 again for each data item you want to add.
14. Select FShunt in the Available items frame.
16. Select ctO2(a-v̄) in the Available items frame.
Patient result settings
To set up automatic printing of acid-base charts
This procedure lets you set up the analyzer to automatically print acid-base charts
when a selected report layout is used during a measurement.
2. Select a report layout.
3. Select the Print Acid-Base chart check button.
Note: Acid-base charts are only printed when all necessary parameter values are
available.
168
Approval and rejection of patient results
Approval/rejection of patient results is not set up by default. If it is set up, it can be

used to filter patient results that are transmitted to a LIS/HIS system. Approved
results are transmitted, rejected results are not.
Note: An approved patient result does not indicate that the result can be used in a
clinical evaluation of the patient.
Approval can for example be used to make sure that necessary data was correctly
entered, for example, that the Sample type was “Venous”, not “Arterial” and the
patient temperature was 42 °C, not 38 °C.
Note: Approved/rejected results cannot be edited.
To enable patient result approval/rejection
2. Select the Enable patient result approval check button.
Parameter settings
To show the parameter bar
2. Select the Show parameter bar check button.
To hide the parameter bar

2. Deselect the Show parameter bar check button.
To enable/disable a parameter
When you disable a parameter, it will not be shown in the parameter bar. You cannot
measure the parameter, it will not be calibrated and no built-in QC measurements will
be done for it.
Note: You cannot disable the pH, pO2 or pCO2 parameters .
Parameters.
3. Tap the Enable/ Disable button.
Note: The first value in the Enabled/locked column must be “Yes” to enable the
parameter, and “No” to disable it.
169
To set up measuring units for parameters

Units.
2. Use the scroll buttons to select the field adjacent to the parameter.
3. In the Possible units frame, select the unit.
To repress a parameter
When you repress a parameter, no value will be given for the parameter in patient
results if an error occurred during the measurement.
If an QC or calibration problem exists repressing a parameter will change the param-

eter tab to red and repress that parameter in subsequent patient results.
Parameters.
4. Select the Repress parameter value in patient result in case of any prob-
lems check button.
To suppress out-of-range results
Only out-of-range oximetry parameters can be suppressed.

• Suppression causes oximetry results (excluding ctHb) that are within the range of
indication* and below zero to be shown as zero, and results that are within the
range of indication* and above 100 % to be shown as 100 %.
• Suppression of ctHb or ctBil** results that are within the range of indication* but
below zero will be shown as zero.
Parameters.
4. Select the Out of range suppression check button.
** Bilirubin can only be measured on neonatal samples. This parameter is only avail-
able in the Neonate blood analysis 65 μL mode.
To fix the number of decimals used in blood-gas results
The analyzer measures the blood gas parameters pO2 and pCO2 more precisely in the
lower part than in the upper part of ranges. By default, results are shown with a
different number of decimal points. For example, in the range 0-99.9 mmHg, pO2(T)
results are shown with one decimal point and in the range 100-750 mmHg, with no
decimal points (that is, in whole numbers).
170
This procedure can be used to make sure pO2 and pCO2 results are shown with the
same number of decimal points in the whole reportable range.
2. Select the Fixed pO2/pCO2 decimals check button.
Related information
Measurement precision within specified ranges, page 372
To enable HbF corrections
Prerequisite: You know if the analyzer is to be used to analyze neonatal samples only,
adult samples only, neonatal samples and adult samples or samples that contain
hemoglobins that deviate from HbA hemoglobins.
This procedure is necessary to make sure that ctBil*, sO2, FO2Hb, FMetHb, FCOHb and
FHHb results are corrected for the presence of HbF in the sample.
2. In the HbF correction frame, choose an option and follow the steps for it.
Option Steps
For neonatal samples Select “Enabled for all levels”
For adult samples Select “Enabled for levels > 20 %”
For neonatal and adult samples Select “Enabled for levels > 20 %”
For adult samples that contain hemo- Select “Disabled”

globins which deviate from HbA hemo-
globins
Note: The “Enabled for all levels” setting will correct ctBil*, sO2, FO2Hb, FMetHb,
FCOHb and FHHb results and show HbF values.
* Bilirubin can only be measured on neonatal samples. This parameter is only available
Related information
Restrictions, page 368
To enable the estimation of derived parameters
This procedure lets the analyzer replace missing measured values and/or keyed-in
values with default values in order to estimate values for derived parameters. Esti-
mated results are marked with the subscript e.
1. Tap Menu > Utilities > General setup > Miscellaneous setup.
2. Select the Enable estimated derived parameters check button.
Related information
Derived parameters, page 314
171
Editing the slope and offset of a parameter
Operator-defined corrections (offset and slope)
Operator-defined corrections refer to corrections made to the offset and/or slope of

parameters.
2 6
0.0
4
1 Offset 4 Measured values (x axis)
2 Shown values (y axis) 5 Correction line without oper-

ator-defined corrections
3 Slope = 1.0 6 Correction line with oper-

ator-defined corrections
The diagram shows the relation between correction lines with and without oper-
ator-defined corrections.
operator-defined corrections are most commonly applied when the values measured for
a parameter by two or more analyzers deviate consistently from each other.
operator-defined corrections are based on a linear correlation between the measured

values (without operator-defined corrections) and the shown values (with oper-
ator-defined corrections).
The correction factors for each measured parameter are the slope and the offset of the
correction line. With operator-defined corrections it is possible to change the values of
the slope and offset or only change the value of one of them. This depends on the
parameter.
Corrected value = Slope × Uncorrected value + Offset
Before you enter corrections for a parameter, you must have the reference value for
the parameter. Use a procedure accepted in your laboratory to get the reference value.
Here are the other prerequisites:
• Analyses must be done on the analyzer without the use of operator-defined correc-
tions and on one reference analyzer
• Analyses must be done over the full measuring range
• Analyses must be done on the analyzer and on the reference analyzer at the same
time, and the samples must be handled correctly
• The slope and the offset must be calculated. You may, for example, make a linear
correlation between the values measured on the analyzer and the reference
analyzer. The analyzer is then used as an independent variable.
• You must verify the corrections entered.
172
Recommendations about samples to use
Parameter Sample description
ctHb Use a SAT100 sample to approximately 15 g/dL (9.3 mmol/L) (which is the
maximum uncorrected or corrected point) and pH is approximately 7.4
sO2 Set ctHb of gas equilibrated SAT0 and SAT100 sample to approximately 15 g/dL
(9.3 mmol/L) and pH is approximately 7.4
FCOHb The zero point (FCOHb approximately zero) is saturated to approximately SAT100,
and ctHb is set to approximately 15 g/dL (9.3 mmol/L) and pH is approximately
7.4
FMetHb The zero point (FCOHb approximately zero) is saturated to approximately SAT100,
and ctHb is set to approximately 15 g/dL (9.3 mmol/L) and pH is approximately
7.4
FHbF Radiometer recommends that the ctHb in adult samples (with FHbF = 0) and fetal
samples (with high FHbF) is set to approximately 15 g/dL (9.3 mmol/L), sO2 is
approximately 100 % and pH is approximately 7.4
ctBil* Radiometer recommends that human plasma or serum is used with pH = 7.4 (the
analyzer reading). Zero point sample could be adult sample (ctBil*)
Limits for slope and offset values
The slope and offset value of some parameters can be changed to values that fall
within the limits stated in the tables.
• For arterial, venous and a-v̄ samples:
Limits for pH and blood gases
Parameter Limits for the slope Limits for the offset value
value
pH 0.95-1.05 (pH unit) ±0.1 (pH unit)
pCO2 0.95-1.05 kPa ±0.5 kPa
pO2 0.95-1.05 KPa ±0.5 kPa
Limits for electrolyte parameters
Parameter Limits for the slope value Limits for the offset value
(mmol/L) (mmol/L)
cK+ 0.75-1.25 ±0.3
cNa+ 0.85-1.15 ±5
cCa2+ 0.8-1.2 ±0.05
cCl - 0.85-1.15 ±5
Limits for metabolite parameters
(mmol/L) (mmol/L)
cGlu 0.75-1.25 ±0.5
173
Limits for metabolite parameters
(mmol/L) (mmol/L)
cLac 0.75-1.25 ±0.5
Limits for oximetry parameters
Parameter Limits for the slope Limits for the offset value
value
ctHb 0.95-1.05 mmol/L ±2 mmol/L
sO2 0.9-1.1 (fraction) ±0.05 (fraction)
FCOHb Cannot be changed ±0.05 (fraction)
FMetHb Cannot be changed ±0.05 (fraction)
FO2Hb Cannot be changed If measurements indicate that it is necessary

to change the offset value for sO2 and/or
FCOHb and/or FMetHb, change it. Use the
equation: sO2 × (1 – FCOHb – FMetHb) to
calculate FO2Hb concentrations.
FHHb Cannot be changed If measurements indicate that it is necessary

to change the offset value for sO2 and/or
FCOHb and/or FMetHb, change it. Use the
equation: (1 – sO2) × (1 – FCOHb – FMetHb)
to calculate FHHb concentrations.
FHbF 0.8-1.2 (fraction) ±0.2 (fraction)
Note: Before samples

are analyzed, “Enabled
for all levels” must be
selected for HbF
correction in the
Miscellaneous setup
screen.
ctBil* 0.5-1.5 (µmol/L) ±100 (µmol/L)
Related information
To enable HbF corrections, page 171
To edit the offset and slope for a parameter
WARNING – Risk of incorrect measurement results

Changes made to the offset and/or slope of parameters will have an effect on patient
results and change some performance characteristics. If you do not want the changes
to have an effect on QC results, too, make sure the Apply parameter corrections to
QC check button is deselected in the Miscellaneous setup screen.
Parameters.
4. If necessary, enter a new value for Correction offset.
174
5. If necessary, enter a new value for Correction slope.

Calibration settings
Details about calibration frequency
By default the analyzer is set up to do automatic calibrations and built-in QC measure-

ments at intervals that enable optimum use to be made of materials in the Solution
Pack. The table provides details.
Note: Automatic calibrations are also done when the Sensor Cassette or Solution Pack
are replaced, in connection with maintenance and troubleshooting procedures and
when the analyzer is restarted.
Calibration identi- Calibration Calibration mate- Default frequency Default

fier (parameters) rial start time
Elec, pH Sensitivity CAL 1 solution Once a day 08:00 hours
(cK+, cNa+, cCa2+, CAL 2 solution

cCl–, pH)
Status CAL 1 solution Every measurement N/A
BG, Met Sensitivity CAL 1 solution Every 4 hours 02:00 hours
(pCO2, cGlu, cLac) CAL 3 solution
BG Sensitivity CAL 1 solution Once a day 16:00 hours
(pO2) Ambient air
Oxi Sensitivity CAL 1 solution Every 3 months N/A

(recommended)
(Oximetry parame- ctHb calibration
ters) solution (S7770)
Status CAL 3 solution • Every 4 hours N/A

• When temperature
drift in the
oximetry optical
system is outside
specified limits
Note: The calibration identifier BG, Met , Oxi and BG, Elec, Met, pH are combina-
tions of those listed in the table.
Related information
Calibration frequency after a Sensor Cassette replacement, page 40
To edit the calibration schedule
Note: Changes made to the default schedule may prevent optimum use of solutions in
the Solution Pack. This is because the automatic calibrations and built-in QC measure-
ments are scheduled by default to be done at times that let the analyzer make
optimum use of the calibration and QC materials in the Solution Pack.
175
This procedure lets you change the default schedule for calibrations, (automatic cali-
brations) and tHb calibrations (sensitivity calibration of oximetry parameters, which is a
manual calibration).
1. Tap Menu > Utilities > Setup > Calibration schedule.

Option Steps
To change the • Select “Calibration” as the Calibration type.

start time for • Tap the Edit button.
automatic cali-
brations • Select a new Start time.
Note: The schedule above shows both the default calibra-

tion schedule as well as the default start time for a number
of specific system checks that are scheduled to start at
00:00 (24:00) hours. The change you make to the start
time in this step will change the start time for both auto-
matic calibrations and other system checks. For example, if
the start time is changed from 00:00 to 02:00 hours, auto-
matic calibrations will be delayed by 2 hours.
To change the • Select “tHb Cal” as the Calibration type.

start time for • Tap the Edit button.
the next sensi-
tivity calibration • Select a Start time.
of tHb • Select an Interval setting.
Note: The day the next calibration is scheduled = [current
date] + [Interval setting].
To link the built-in QC schedule to the calibration schedule
This procedure changes the current schedule for built-in QC measurements to the
default schedule. This lets the analyzer make optimum use of the solutions in the Solu-
tion Pack.
1. Tap Menu > Utilities > Setup > Calibration schedule.

2. Select “Calibration” in the Calibration type field.
3. Select the Link QC schedule with calibration schedule check button.
176
To set up corrective actions for overdue scheduled calibrations
This procedure lets you select what the analyzer must do when scheduled calibrations
are overdue.
2. Select “Calibration schedule reminder(s)”.
Option Steps
To select the color of the traffic light Tap the Traffic light signal check
signal on the Analyzer status button button until it shows the color you want
To attach a message about the overdue Make sure the check button in the
scheduled calibration to patient results Corrective action(s) frame is selected
Quality control
Glossary of quality control terms
Term Explanation
Accepted result A QC result that falls within the statistical range
Assigned value The assigned value is the center value of a control range.
Note: For Radiometer quality control solutions used for ampoule-based QC

measurements, control ranges are given in the insert.
Control range The range within which a QC result should fall. The control range is calculated
to be the mean value ± 2 SD.
Note: This range can be set to the lot-to-date range (2 SD) calculated by the
analyzer.
Insert range The upper and lower limits of a control range established for a Radiometer
quality control solution.
The ranges are calculated from the results of 30-50 QC measurements done
on each of 10 analyzers. Measurements are done 2-5 times a day over a
period of 1-4 weeks.
Lot-to-date A range calculated by the analyzer based on a minimum number of measure-

range ments done with a specific lot of a quality control solution. It is the mean
value ±2 SD.
Statistical factor The factor which a control range is multiplied by to determine the statistical
range. The recommended statistical factor is 1.5.
Statistical range The range within which a QC result must fall in order to be included in the QC
statistics. It is determined by multiplying the control range limits by the stat-
istical factor. When the recommended statistical factor of 1.5 is used, the stat-
istical range will be the mean ±3 SD.
177
Registration of QC solutions
Why is it necessary to register QC solutions?
When a QC solution is registered, data about the solution is saved on the analyzer. The
data is necessary to evaluate QC results. For example, to make sure that the result
falls within the specified control range and mark the results that do not. It is only
necessary to register a specific lot of a QC solution one time.
About registration of QC solutions
QC measurement About registration of the QC solutions used

type
Built-in QC measure- The QC solutions are automatically registered when the Solution Pack is
ments installed. A chip on the Solution Pack supplies data about the solutions.
Ampoule-based QC Each lot of each level of QC solution must be manually registered before
measurements use. This applies to Radiometer and non-Radiometer QC solutions.
The ABL90 FLEX barcode on the product insert for each level of
Radiometer QC solution supplies data about it. The data is saved on the
analyzer and used when ampoule-based QC measurements are done
with the solution.
To register a Radiometer QC solution for ampoule-based QC

measurements
Prerequisite: The product insert (the document supplied with the QC solution).
You must register each level of each lot of QC solution before you can use them.
1. Tap Menu > Utilities > Setup > QC setup > QC solutions.
2. WARNING – Risk of data loss
Select a Slot that contains no data. If you select a slot that contains data, all stat-
istical data related to the QC solution registered in the slot will be irreversibly
deleted.
Note: The number of the slot can be thought of as a registration number.
3. Scan or enter the barcode for the ABL90 FLEX analyzer from the product insert.
Post-requisite: If local, state or federal regulations require it, establish analyzer-specific

control ranges.
Data saved during registration of Radiometer QC solutions
During registration the barcode for the ABL90 FLEX analyzer is scanned from the
product insert. The screen shows the data that is read from the barcode and saved on
the analyzer.
178
1 Slot 1 – The slot number tells the 5 Insert range – The control range
analyzer where data for the specific given on the product insert for the
lot of the QC solution is stored analyzer
2 The generic name of the QC solu- 6 Assigned Value – The center

tion – The character S followed by value of the Insert range
a four digit number. For example,
S7750.
3 Lot: – The lot number of the QC 7 Control range – By default, the

solution control range is given the same
values as the Insert range.
4 Parameter – The parameters that
can be measured Note: If local, state or federal
regulations require it, control
ranges can be changed to
analyzer-specific control ranges
established by your laboratory.
Related information
How to establish analyzer-specific control ranges, page 191
To register a non-Radiometer QC solution
Prerequisite: Control ranges for the parameters to be measured with the QC solution.
Note: If non-Radiometer QC solutions are used, Radiometer cannot guarantee accu-

rate, valid QC results.
Note: Results of QC measurements done with non-Radiometer QC solutions are not
automatically temperature corrected.
2. Select a Slot that contains no data.
Note: The number of the slot can be thought of as a registration number.
3. Tap the Add non-R- button.
179
4. Write down the number of the Slot. The number is necessary in step 7 of this
procedure.
6. Tap Menu > Utilities > Setup > QC setup > QC ranges.
7. Tap the Next slot button to select the number of the slot you wrote down in step
4.
9. Enter values for the Current control range of the parameter shown on the
screen.
10. Tap the Next param．button to select the next parameter.
11. Enter values for the Current control range of the parameter shown on the
screen.
12. Do steps 10 and 11 again for all parameters.
Data saved during registration of non-Radiometer QC solutions
Here is the data that can be saved during registration of a non-Radiometer QC solu-
tion:
• Generic name Non-R-
• Control range for each parameter
Quality control solutions
To set up the temperature field for QC measurements
Note: QC results are temperature dependent. That is why there is a Temperature

field in the Quality control identification screen that is shown during ampoule-based
QC measurements.
This procedure lets you make it mandatory to enter the room temperature in Temper-
ature field, or set a default value in the field.
Note: If necessary, a set default temperature can be changed during an
ampoule-based QC measurement.
1. Tap Menu > Utilities > Setup > QC setup > QC input setup.
Option Steps
To make the Temperature field mandatory. Select the Mandatory

temperature: check button.
Note: When this option is chosen, operators
must enter the room temperature before QC
results are shown.
To set a default temperature Enter a temperature in the

Default temperature: field.
180
Scheduled QC measurements
To schedule ampoule-based QC measurements
Prerequisite: The QC solution is registered.
1. Tap Menu > Utilities > Setup > QC setup > QC schedule.
3. Select the registered QC solution, on the right of the screen.
5. Enter a start time.
6. Select a value for the Repeat: field, on the right of the screen.
7. If you selected a value less than 24 hours in step 6, select check buttons for the
days of the week QC measurements must be done.
To edit the schedule for ampoule-based QC measurements

2. Select the scheduled measurement you want to edit. Scheduled ampoule-based
measurements are marked by diamond-shaped icons.
Option Steps
To only delete the selected a) Tap the Delete button.

scheduled measurement b) Tap the Event for this day.
To delete all measurements a) Tap the Delete button.

with the selected solution that b) Tap the Event for all days.
are scheduled at this time of
the day
To delete all scheduled meas- a) Tap the Delete button.

urements with the selected b) Tap the All entries for QC slot <n>.
solution
Note: <n> is a number.
To change the days of the week a) Tap the Edit button.

measurements must be done b) Tap in the Weekdays: field.
c) Select the check buttons for the days of the
week measurements must be done.
d) Tap the OK button.
To change the start time for a) Tap the Edit button.

measurements b) Tap the Start time: field.
c) Enter a new start time.
To change how frequently a) Tap the Edit button.

measurements must be done b) Tap the Repeat: field.
c) Select a value from the field on the right of
the screen.
181
Built-in QC measurement frequency
A built-in QC measurement is scheduled by default to be done every 8 hours. One

measurement a day is done with each QC solution. Built-in QC measurements are also
scheduled by default to be done in connection with these activities:
• Replacement of the Solution Pack

• Replacement of the Sensor Cassette
• Startup
You can edit the schedule for built-in QC measurements.
To edit the schedule for built-in QC measurements
Prerequisite: The schedule for built-in QC measurements is not linked to the calibration
schedule.
2. Select the scheduled built-in QC measurement you want to edit. Scheduled built-in
QC measurements are marked by diamond-shaped icons and stars.
Note: Built-in QC measurements are done with QC solutions registered in slots A,
B and C.
182

Option Steps
To restore the default setup for Tap the Reset Built-in QC button.
scheduled built-in QC measure-
ments
To only delete the selected a) Tap the Delete button.

scheduled measurement b) Tap the Event for this day.
To delete all measurements a) Tap the Delete button.

with the selected solution that b) Tap the Event for all days.
are scheduled at this time of
the day
To delete all scheduled meas- a) Tap the Delete button.

urements with the selected b) Tap the All entries for QC slot <n>.
solution
To change the days of the week a) Tap the Edit button.

measurements must be done b) Tap in the Weekdays: field.
c) Select the check buttons for the days of the
week measurements must be done.
To change the start time for a) Tap the Edit button.

measurements b) Tap the Start time: field.
c) Enter a new start time.
To change how frequently a) Tap the Edit button.

measurements must be done b) Tap the Repeat: field.
c) Select a value from the field on the right of
the screen.
To schedule built-in QC meas- This is the default setting. Radiometer recom-

urements to be done after mends that you do not change this setting.
replacement and startup proce-
dures
To remove built-in QC meas- Radiometer recommends that you do not use

urements after replacement this option.
and startup from the schedule
Deselect the Run built-in QCs after replace-
ment and startup check button.
Note: If this option is selected, Radiometer
recommends that you do ampoule-based QC
measurements after replacement and startup
procedures.

5. If a pop-up screen is shown, choose an option and follow the steps for it.
Option Steps
To accept the new schedule Tap the Accept button.
To change the schedule • Tap the Back button.

• Do steps 3 to 5 again.
Related information
To link the built-in QC schedule to the calibration schedule, page 176
183
To request ampoule-based QC measurements after replacements
This procedure lets you set up the analyzer to request ampoule-based QC measure-
ments after Sensor Cassette and/or Solution Pack replacements. The analyzer will be
locked until the ampoule-based QC measurements are done.
2. Select the QC solution to be used for an ampoule-based QC measurement.
Option Steps
To request ampoule-based QC meas- a) Select the Request QC after Solu-

urements after Solution Pack replace- tion Pack replacement check
ments button.
To request ampoule-based QC meas- a) Select the Request QC after Sensor

urements after Sensor Cassette Cassette replacement check
replacements button.
4. Do steps 2 and 3 again for each QC solution to be used for an ampoule-based QC
measurement after a replacement.
Corrective actions on QC results
To set up corrective action for errors in QC results
Three corrective actions are available to show errors in QC results.

• Attach a question mark symbol to patient results until the QC error is removed
• Select the color of traffic light shown on the left side of the Quality control button
in the Analyzer status screen.
• Do not show patient results for parameters with QC or other errors. See Related
information.
Note: A successful QC measurement can remove the error.
2. Select the condition “QC error(s) present”.
Option Steps
To change the traffic light color a) Make sure the ? on specific parameters
check button is deselected.
b) Tap the traffic light symbol until it shows the
color you want.
To attach a question mark Select the ? on specific parameters check

symbol to patient results button.
Note: This option will also set the traffic light
color to yellow.
Related information
To repress a parameter, page 170
184
To set up corrective actions for overdue scheduled QC measurements
Three corrective actions are available to show that scheduled QC measurements are
overdue.
• Select the color of traffic light shown on the left side of the Quality control button
• Attach a message about overdue QC measurements to all patient results until the
measurements are successfully completed.
• Lock the analyzer
Note: When the analyzer is locked, no patient samples can be analyzed until
overdue scheduled QC measurements are successfully completed.
2. Select the condition “QC schedule reminder(s)”.
3. Choose the option you want and follow the steps for it.
Option Steps
To change the traffic light color Tap the traffic light symbol until it shows the
color you want.
To attach a message to subse- Select the Message on next patient result

quent patient results check button.
To lock the analyzer Select the Lock analyzer when QC overdue

check button.
To apply operator-defined corrections to QC results
Operator-defined corrections refer to corrections made to the offset and slope for
parameters.
2. Select the Apply parameter corrections to QC check button.
Related information
Limits for slope and offset values, page 173
To set up corrective action for errors in built-in QC measurements
This procedure lets you set up the analyzer to do built-in QC measurements again
when there are errors in the built-in QC results.
2. Select the condition “Built-in QC error(s) present”.
3. Select the Rerun same level once check button.
185
QC statistics
To set up automatic print of built-in QC statistics
This procedure lets you set up the analyzer to automatically print QC statistics for
built-in QC when you start to use a new lot of a QC solution.
1. Tap Menu > Utilities > Setup > QC setup > QC statistics.
2. Select the check button in the Built-in QC frame.
Statistical factor
The statistical factor expands the control range to the statistical range, which is the
range within which QC results must fall to be included in QC statistics.
Note: The statistical range = [Control range] × [Statistical factor]. Only QC results
that fall within the statistical range are included in QC statistics.
To set the statistical factor

1. Tap Menu > Utilities > Setup > QC setup > QC statistics.
2. If necessary, enter a new value In the Statistical factor used for value accept-
ance field.
Note: The default value is 1.5.
Westgard Rules
About Westgard Rules
Westgard Rules are a set of control rules that can be applied to QC results to help you
do two things:
• Find errors in QC results. The symbol “W” is used to show when QC results have
violated applied Westgard Rules.
• Find shifts or trends in QC results. This helps you assess the quality and validity of
patient sample analyses.
Types of Westgard Rule
There are two types of rule.
• Warning rules. Rule 12s is the only warning rule.

• Rejection rules. Rules 13s, 22s, R4s, 41S and 10x are rejection rules.
Description of the lines used in Westgard rule illustrations
Line type Description
.......... Shows ±3 SD ranges
___ Shows control ranges (±2 SD)
186
Line type Description
_____ Shows the mean value
Westgard rules and corrective actions
The 4 Westgard rules (1:3s, 2:2s, R:4s and 4:1s) can be applied to built-in and
ampoule-based QC results. Rule 41s and Rule 10x can only be applied to
Rule 1:2s (also written 12s) is a warning rule.
Westgard rule 12s Corrective action
The QC result Do a new measurement with QC material of

falls outside the same type, level and lot number.
the mean ±2 • If the new result does not fall outside the
SD range mean ±2 SD range, the original QC result
can be attributed to normal statistical
variation.
• If the new result falls outside the mean ±2
SD range, do what is necessary to be in
compliance with your local QC regulations.
Rule 1:3s (also written 13s) is a rejection rule.
The QC result Do a new measurement with QC material of

falls outside the same type, level and lot number.
the mean ±3 • If the new result does not falls outside the
SD range mean ±3 SD range, the original QC result
can be attributed to normal statistical
variation.
• If the new result falls outside the mean ±3
SD range, do what is necessary to be in
compliance with your local QC regulations.
Two consecu- Do what is necessary to be in compliance with

tive QC results your local QC regulations.
fall outside
and on the
same side of
the mean ±2
SD range
Rule R:4s (also written R4s) is a rejection rule.
187
Westgard rule R4s Corrective action
The difference Do what is necessary to be in compliance with

between two your local QC regulations.
consecutive
QC results is
greater than 4
SD
This indicates that there is

inconsistency in your QC
procedures or your analyzer is
not stable.
Four consecu- Do what is necessary to comply with your local

tive QC results QC regulations.
are on the
same side of Note: This rule can only be applied to
the mean ±1 ampoule-based QC results. Radiometer recom-
SD mends that this rule is only applied if the
parameter control ranges have been changed
This indicates a trend or shift. to analyzer-specific control ranges calculated
from a minimum of 20 ampoule-based QC
measurements.
Rule 10:x (also written 10x) is a rejection rule.
Westgard rule 10x Corrective action
Ten consecu- Do what is necessary to comply with your local

tive QC results QC regulations.
are on the
same side of Note: This rule can only be applied to
the mean ampoule-based QC results. Radiometer recom-
mends that this rule is only applied if the
parameter control ranges have been changed
This indicates a trend or shift. to analyzer-specific control ranges calculated
from a minimum of 20 ampoule-based QC
measurements.
To set up and enable Westgard Rules
This procedure lets you setup and enable Westgard Rules for selected QC solutions.
The rules can be set up for built-in QC solutions and ampoule-based QC solutions.
1. Tap Menu > Utilities > Setup > QC setup > Westgard Rules.
2. Make sure that there is a checkmark on the On/Off button. If there is no check-
mark, tap the button.
3. Tap the Next slot button to select the QC solution.
188

Option Steps
To apply all Westgard a) Tap the Select all button.

rules to QC results for
all parameters. Note: Rule 4-1S and 10-X cannot be applied to QC
solutions in slot A, slot B or slot C.
b) Tap the Continue button.
To apply some a) Select a parameter.

Westgard rules to QC b) Tap the Edit button.
results of some
parameters c) Select the check buttons of the rules you want to
apply.
d) If necessary, tap the Next param or Prev param
button to select a new parameter and do step c)
again.
To disable/enable Westgard rules
Prerequisite: Westgard rules are set up.
This procedure lets you disable/enable the Westgard rules that are set up on all QC
solutions.
1. Tap Menu > Utilities > Setup > QC setup > Westgard Rules.
Option Steps
To disable Westgard rules Deselect the On/Off check button.
To enable Westgard rules Select the On/Off check button.

RiLiBÄK rules
About RiLiBÄK rules
RiLiBÄK rules are guidelines of the German Federal Medical Council. The rules provide
minimum requirements for the quality of quantitative test results in medical laborato-
ries.
To add a new RiLiBÄK rule
This procedure lets you add a new rule.
1. Tap Menu > Utilities > Setup > QC setup > RiLiBÄK ranges.
3. Select the parameter you want.
4. Tap in the first Lower limit: field.
5. Enter the value of the lower limit.
6. Tap in the second Lower limit: field.
7. Tap < or <=.
8. Tap in the first Upper limit: field.
189
9. Tap < or <=.

10. Tap in the second Upper limit: field.
11. Enter the value of the upper limit.
Option Steps
To use a percentage to calculate the • Select the +/- Ranges [%] radio
acceptable deviation from the assigned button.
value. The assigned value is the center
• Enter the percentage value in the
value of the range you entered in step
5 and step 11. Ranges: field.
Note: This is the option most

frequently chosen.
To use an absolute value to calculate • Select the +/- Ranges radio

the acceptable deviation from the button.
assigned value
• Enter the absolute value in the
Ranges: field.
14. Do steps 2 to 13 again for each rule you want to add.
Note: More than one rule can be added for a parameter if the ranges for each rule
do not overlap.
To apply all RiLiBÄK rules
Prerequisite: RiLiBÄK rules are set up.
This procedure lets you apply all the RiLiBÄK rules that are set up. You cannot select
which rules to apply.
2. Make sure there is a check mark on the On/Off button. If there is no check mark,
tap the button.
To edit a RiLiBÄK rule

2. Select the rule you want to edit.
4. Edit the values.
5. If necessary, choose an option and follow the steps for it.
Option Steps
To use a percentage to calculate the • Select the +/- Ranges [%] radio
acceptable deviation from the assigned button.
value.
• Enter the percentage value in the
Note: This is most frequently used. Ranges: field.
To use an absolute value to calculate • Select the +/- Ranges button.

the acceptable deviation from the • Enter the absolute value in the
assigned value.
Ranges: field.
190
To remove a RiLiBÄK rule

2. Select the rule you want to delete.
Analyzer-specific control ranges
About analyzer-specific control ranges
If local, state or federal regulations require your laboratory to establish and use
analyzer-specific control ranges for the QC solutions used for ampoule-based QC meas-
urements, it can be done.
The analyzer-specific control ranges established in your laboratory must then be used
to replace the default Control range values given to parameters when QC solutions
are registered for use. The default values are the control ranges given on the product
insert. These values are shown in the Insert range column of the Quality control
ranges setup screen.
The control range values given in the insert are not analyzer-specific. They were estab-
lished as follows: QC measurements were done on a number of ABL90 FLEX analyzers.
Different lots of QC solution were used. Measurements were done by different opera-
tors, over several days. Different Solution Packs were also used to take lot-to-lot varia-
tions of calibration solutions into account.
How to establish analyzer-specific control ranges
Establishment of analyzer-specific control ranges is a 3-stage process:

• Stage 1: Do 20 ampoule-based QC measurements with each level of QC solution.
• Stage 2: Enable the use of Fixed SD values to parameters to make sure that the
lot-to-date ranges calculated in stage 3 are not made too narrow.
• Stage 3: Use the analyzer to change control ranges to lot-to-date ranges.
191
Stage 1: To do 20 ampoule-based QC measurements
Prerequisites:
• Radiometer QUALICHECK5+ quality control solutions are registered for use

• The QC ampoules are prepared for use
Note: This procedure is only necessary if local, state and federal regulations require
you to do ampoule-based QC measurements that are based on analyzer-specific
control ranges established by your laboratory.
Radiometer recommends that measurements done in this procedure are done by more
than one person over a period of 4-5 days. This will take into account
sample-to-sample, operator-to-operator and day-to-day variations.
1. Do a minimum of 20 ampoule-based QC measurements with each level of QC solu-

tion.
Related information
Data saved during registration of Radiometer QC solutions, page 178
To prepare a Radiometer QC ampoule for use, page 69
Stage 2: To enable the use of fixed standard deviations
You can use this procedure to make sure that the analyzer-specific control ranges
calculated in stage 3 of the process are not made too narrow. The Fixed SD values
enabled for use during this procedure are only used when they are found to be greater
than the calculated standard deviations of the measurements made in stage 1 of the
process.
2. Tap the Next slot button to find the QC solution you want to edit.
5. Select the check button in the Fixed SD field.
Note: The value shown is a Radiometer value.
6. Tap the Next param . or Prev param．button to select a new parameter.
7. Select the check button in the Fixed SD field.
8. Do steps 6 and 7 again for each parameter.
Stage 3: To use the analyzer to change control ranges to

analyzer-specific control ranges
Note: Radiometer recommends that you do Stage 1 and 2 of the process before you
do stage 3.
The analyzer uses all successful QC results to calculate the mean value and standard
deviation (SD) values of parameters. The lot-to-date range is calculated as follows:
Lot-to-date range = [Mean value] ± [2 × calculated SD value]
The analyzer then updates the Control range of parameters. It compares the calcu-
lated SD values with the Fixed SD values that were enabled for use in stage 2 of the
process.
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• If a [calculated SD value] > [Fixed SD value], the control range of the parameter is
changed to the lot-to-date range
• If a [calculated SD value] < [Fixed SD value], the control range of the parameter is
changed to the control range calculated as follows:
Control range = [Mean value] ± [2 × Fixed SD value].
This makes sure that the control ranges are not made too narrow.
Note: The number of successful QC measurements are shown in the N column.
2. Tap the Next slot button to find the QC solution you want to edit.
3. Tap the Update all button.
Note: The control ranges of all parameters are now analyzer-specific.
To manually change control ranges to analyzer-specific control

ranges
Prerequisite: Established analyzer-specific control ranges.
Note: This procedure is only necessary if local, state and federal regulations require
you to do ampoule-based QC measurements that are based on analyzer-specific
control ranges established by your laboratory. The procedure lets to change the control
ranges manually.
2. Tap the Next slot button to find the specific lot and level of QC solution you want
to edit.
3. Select a parameter.
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5. Enter the values of the analyzer-specific control range in the Current control
range frame.
6. To change the control range of the other parameters, do as follows for each
parameter:
a) Tap the Next param．button.
b) Do step 5 again.
Note: The entered values are shown in the Control range column of the Quality
control ranges setup screen.
Maintenance setup
About mandatory and operator-defined activities
There are 2 types of maintenance activity:
• Mandatory – activities that must be done

• Operator-defined – activities that can be set up by operators
Mandatory maintenance activities
Other activities
Other activities are mandatory replacement activities that are scheduled or can be
scheduled to be run at regular intervals of time. For example, to clean the screen.
Other activities are shown in the Other activities part of the Analyzer status screen.
When a scheduled activity is due, a reminder is shown in the Analyzer status screen.
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To schedule other activities

1. Tap Menu > Utilities > Setup > Replacement setup > Replacement
schedule.
2. Select the activity in the Replacements column.
4. Select the frequency for the activity in the Interval field.
Note: The first date for the scheduled activity is shown in the Next date field. The
time is equal to the current date plus the number of days selected in the Interval
field.
Option Steps
To change the first date for the sched- a) Tap in the Next date field.
uled activity b) Enter a new date.
To accept the first date for the sched- Go to the next step.
uled activity
To set up corrective action for overdue Other activities
Prerequisite: Other activities are scheduled.
Three corrective actions are available to show that scheduled Other activities are
overdue.
• Select the color of traffic light shown on the left side of the Other activities button
• Attach a message about overdue scheduled activities to all patient results until the
activities are successfully completed.
• Lock the analyzer when a scheduled activity is more than 10 % overdue.
Note: When the analyzer is locked, no patient samples can be analyzed until
overdue scheduled activities are successfully completed.
For example: If an activity is scheduled to be done every 10 days and the activity is
not done [10 days + (10 % of 10 = 1) day] = 11 days after the activity was last
done, the analyzer locks.
2. Select the condition “Replacement schedule reminder(s)”.
3. Choose the option you want and follow the steps for it.
Option Steps
To change the traffic light color Tap the traffic light symbol until it
shows the color you want.
To attach a message to subsequent Select the Message on next patient

patient results result check button.
To lock the analyzer when the activity is Select the Lock analyzer when 10 %
more than 10 % overdue overdue check button.
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Operator-defined activities
Operator activities
Operator activities are activities you can set up and schedule to be done at regular
intervals of time. For example, to clean the touch screen and analyzer exterior. When a
scheduled activity is due, a message is sent as a reminder to do the activity.
To set up an operator activity

1. Tap Menu > Utilities > Setup > Replacement setup > Operator activities.
3. Enter a name for the activity.
4. Select the frequency for the activity in the Interval field.
Note: The first date for the scheduled activity is shown in the Next date field. The
time is equal to the current date plus the number of days selected in the Interval
field.
Option Steps
To change the first date for the sched- a) Tap in the Next date field.
uled activity b) Enter a new date.
To accept the first date for the sched- Go to the next step.
uled activity
To set up corrective action for pending operator activities
This procedure lets you set up the analyzer to change the color of the traffic light
shown on the left side of the Other activities button in the Analyzer status screen
to remind operators about pending operator activities.
2. Select the condition “Operator activity reminder(s)”.
3. Tap the button with the traffic light symbol to select the color you want to show.
To delete an operator activity

1. Tap Menu > Utilities > Setup > Replacement setup > Operator activities.
2. Select the activity.
Maintenance planning
To plan maintenance activities
This procedure lets you enter the periods of time that people who maintain the
analyzer are available each day. The analyzer uses this information to send reminders
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about maintenance activities so they can be done when people who maintain the
analyzer are available. This procedure can be used to decrease analyzer down time.
1. Tap Menu > Utilities > Setup > Replacement setup > Maintenance plan-
ning.
2. Select the check button for the days that people who maintain the analyzer are
available.
3. Enter the start and end time that people who maintain the analyzer are available.
Replacement warnings
To set up replacement warnings
Replacement warnings are messages that can be set up to tell operators that installed
consumables (Solution Pack/Sensor Cassette) will soon have to be replaced. You can
set up two conditions to cause a message to be sent.
• the number of remaining activities/tests falls below a selected value
• the number of hours that remain before a consumable expires falls below a selected
value
1. Tap Menu > Utilities > Setup > Replacement setup > Replacement warn-
ings.
2. Select a number in the Expected measurements per day field, so the analyzer
can calculate the most probable replacement date.
3. Select a number in the Number of tests before replacement warning field.
4. Select a time period in the Time before replacement warning field.
Note fields
To create standard texts for use in Note fields

User-defined notes.
2. Select the check button for the screen where you want standard text to be avail-
able for use in the Note field.
4. Enter the standard text.
5. Do steps 3 and 4 again for each standard text you want to add.
To edit standard texts for use in Note fields

User-defined notes
2. Select the note you want to edit.
4. Edit the note.
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To delete standard texts for use in Note fields

1. Tap Menu > Utilities > Setup > General setup > Paramters and input >
User-defined notes.
2. Select the note you want to delete.
Communications
To set up a LIS/HIS connection
Prerequisite: Connection to a network.
1. Tap Menu > Utilities > Setup > General setup > Communications >
LIS/HIS connection.
3. Enter a name for the connection.
5. Select the high-level protocol used by the LIS/HIS system.
Option Steps
To set up a serial low-level protocol a) Select a serial setting.

b) Tap the Edit button.
c) Tap the Edit button again.
d) If necessary, change the settings.
e) Tap the Back > Back > Close buttons.
To set up a network low-level a) Select a network setting.

protocol b) Tap the Edit button.
c) If necessary, change the settings.
d) Tap the Back > Close buttons.
To set up a AQURE/RADIANCE connection
1. Tap Menu > Utilities > Setup > General setup > Communications >
AQURE/RADIANCE connection.
2. Enter the address of the AQURE/RADIANCE server the analyzer is connected to.
3. Enter the number of the AQURE/RADIANCE server port the analyzer is connected
to.
4. Enter the password the analyzer was given to access the AQURE/RADIANCE
system.
5. Select the Communicate with AQURE/RADIANCE checkbox.
Note: The status “Connected” is shown in the Connection status frame.
At the bottom of the analyzer screen the icon shows if there is a connection or not:
Icon Explanation
There is a connection between the system and the analyzer
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Icon Explanation
There is no connection between the system and the analyzer
Patient data from a LIS/HIS or AQURE/RADIANCE system
Patient data can be downloaded to the analyzer from a connected LIS/HIS or

You can set up the analyzer to request patient data automatically from the system, or
let operators request patient data manually. There are 2 options for manual requests:
• Fill in the Accession number, Patient ID or Sampler ID field in the Patient
identification screen and request the patient data.
• Fill in the Patient department field in the Patient identification screen, lookup,
find and request the patient data.
Note: To use this option, you must enable patient lookup.
To set up automatic requests for patient data
Prerequisite: A connection is set up to the LIS/HIS or AQURE/RADIANCE system that

patient data is to be requested from.
1. Tap Menu > Utilities > Setup > General setup > Communications > Auto-
matic data request.
2. Select the connection to the system that patient data is to be requested from.
3. In the Request patient demographics frame, select the check button for the
data field in the Patient identification screen that when filled in will automati-
cally request patient data from the system.
Note: It is possible to select more than one check button, but Radiometer recom-
mends that you only select one.
To set up automatic transmission of data to a system
Prerequisite: A connection is set up to the LIS/HIS and/or AQURE/RADIANCE system

that data is to be sent to.
1. Tap Menu > Utilities > Setup > General setup > Communications > Auto-
matic data transmission.
2. Select the name of the connection.
3. Select the check buttons for the data to be automatically sent.
4. Do steps 2 and 3 again for each system that you want to transmit data to.
To enable manual patient data requests using Patient lookup
Prerequisites:
• If data is to be requested from an LIS/HIS or AQURE/RADIANCE system, a connec-
tion must be set up to the system
• The selected Patient report contains the Department (Pat.) field
Patient data can be requested from the analyzer database, a connected LIS/HIS or
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This procedure lets operators request patient data manually, via a Patient lookup
button, after they have filled in the Department (Pat.) field of the Patient identifi-
cation screen.
1. Tap Menu > Utilities > Setup > General setup > Communications > Patient
lookup setup.
2. Select the name of the connection.
3. Select the number of days after patient data is saved in the Patient profiles log
that it must be available for use. The default is 7 days.
4. Tap the Close screen.
To access the RADIANCE system from the analyzer
Prerequisites:
• A connection to the RADIANCE system. This must be set up.
• Access to the RADIANCE system. Access is available on request. Contact your local
Radiometer representative.
1. Make sure the RADIANCE icon shows there is connection between the analyzer and
the RADIANCE system.
If there is a connection, this icon is shown:
2. Tap Menu > Utilities > RADIANCE browser.
Note: See the RADIANCE system, User's manual for instructions.
To set up a QA Portal connection

1. Tap Menu > Utilities > Setup > General setup > Communications > QA
Portal connection.
2. Enter the TCP/IP address of the QA Portal server the analyzer is connected to.
3. Enter the number of the QA Portal server port the analyzer is connected to.
4. Select the Communicate with QA Portal check button.
Note: The Connection status frame shows whether or not there is a connection.
Printers
To set up automatic printing

1. Tap Menu > Utilities > Setup > General setup > Printers > Automatic
printing.
2. Select the check buttons for the data you want to be printed automatically.
Note: If you select the QC results check button, built-in and ampoule-based QC
measurement results will be printed.
3. Select the number of copies of patient results that must be printed.
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To install an external printer for the analyzer
This procedure must be done by your local Radiometer representative.
1. Tap Menu > Utilities > Setup > General setup > Printers > Printer setup.
2. Tap the Install printer button and follow the instructions shown on the screen.
3. If necessary, tap the Edit name button and enter the new name.
4. Do step 2 and 3 again for each printer you want to install.
Note: Radiometer recommends that a maximum of 10 printers are installed.
Option Steps
To print data on the same a) Select the printer.

printers each time b) Tap the Select/deselect button.
c) Make sure a check mark is shown adjacent
to the printer name.
d) Do steps a) to c) again for each printer.
To get a list of the installed Select the check button in the Manual printing
printers before you print data frame.
To print data on all installed Make sure that the check button in the Manual
printers printing frame is deselected.
To edit the name of a printer

1. Tap Menu > Utilities > Setup > General setup > Printers > Printer setup.
2. Select the printer.
3. Tap the Edit name button, and enter the new name.
Data logs and archives
About data logs and archived data logs
The analyzer can be set up to automatically save data logs to archives on the analyzer
or on an external device. Data is moved to the archives when the data logs are full.
You can export data logs and archived data logs manually and save them on an
external device. You can also import archives from other ABL90 FLEX analyzers.
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To set up automatic archiving

1. Tap Menu > Utilities > Setup > General setup > Disk functions setup >
Automatic archiving.
2. Select the check buttons for the data logs that you want to be archived.
3. Choose an option and follow the steps for it:
Option Steps
To archive the data logs on the a) Select the Store archives on the analyzer
analyzer check button.
b) Tap the Close button.
Note: The data is saved on the D: drive.
To archive the data logs to a a) Deselect the Store archives on the

different destination analyzer check button.
b) Select an external drive.
c) Tap the button with the folder icon.
d) Select the folder where the data logs must
be archived.
e) Tap the Back > Close buttons.
File format of exported data logs and archived data logs
Data logs can be exported as compressed Comma Separated Value (CSV) files. The
CSV files can be read by database and spreadsheet programs. For example: Microsoft
Excel, Access and Lotus 1-2-3.
However, archived data logs can also be exported as .bin files. The .bin files are
encrypted. If you want to read them, you must import them to the analyzer.
To export data logs
This procedure lets you export one or more data log from the analyzer in .csv format.
Note: Data logs are not removed from the analyzer during this procedure. The
exported data logs are only copies.
1. Make sure that there is a connection between the analyzer and the device to which
the logs are to be exported.
2. Tap Menu > Utilities > Disk functions > Export data logs.
3. Deselect the check buttons for the data logs that you do not want to export.
4. Tap the button with the calendar icon in the Date interval frame.
5. Enter a date in the From: and To: fields.
7. Tap the check button on the right side of the Directory: field.
8. Select the folder on the external drive you want to export the data logs to.
10. Tap the Start button.
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To export data from Archived data logs
This procedure lets you export part of an archived data log from the analyzer in .csv
format.
the archive is to be exported.
2. Tap Menu > Data logs > Archived data logs.
3. Select the archive type.
4. Select a date interval.
5. Tap the Export archive button.
6. Select the folder on the external drive that you want to export the archived data
log to.
To create disc space by exporting and deleting archives
This procedure lets you export archives to an external system and then delete them
from the analyzer database to create space. The files are moved in .bin format. They
cannot be read by database or spreadsheet programs. They must be imported to the
analyzer to be read.
the archive parts are to be exported.
2. Tap Menu > Utilities > Disk functions > Import / Export archives.
4. Select an archive.
5. Tap the button with the folder icon in the Source/Destination: frame.
6. Select the folder to export the archive to.
8. Tap the Export button.
9. In the Archives stored on analyzer: frame:
a) Select the archive that you selected in step 4 and have just exported.
b) Tap the Delete button.
10. Do steps 3 to 9 again for each archive you want to export and delete.
To import archived data logs

1. Make sure that there is a connection between the analyzer and the device that
contains the archives.
2. Tap Menu > Utilities > Disk functions > Import / Export archives.
4. Tap the button with the folder icon in the Source/destination frame.
5. Select the folder that contains the archives you want to import.
7. Select one of the archives in the Source/destination frame.
8. Tap the Import button.
9. If necessary, do steps 7 and 8 again.
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Data backup and restoration
Backup
A backup includes all data logs and system files. Backup can be set up to be done
automatically. The backup can also be done manually.
If data is lost or damaged, the backup will restore most of the data and keep data loss
to a minimum.
Note: The customer must make sure that a backup is done regularly.
Destinations for backup data
A backup can be saved to these destinations.

• An external CD drive
• A folder on an external network drive
To schedule automatic backups

1. Create a folder for the backup on the device on which the backup is to be saved.
2. Make sure that there is a connection between the analyzer and the device.
3. Tap Menu > Utilities > Setup > General setup > Disk functions setup >
Automatic backup.
4. Select the Automatic backup of all data- and system files check button.
5. Enter the time.
6. Enter the number of days between subsequent backups.
7. Tap the button with the folder icon.
8. Select the folder where the backup is to be saved.
To do a manual backup
1. Create a folder for the backup on the device on which the backup is to be saved.
2. Make sure that there is a connection between the analyzer and the device.
3. Tap Menu > Utilities > Disk functions > Backup all data.
4. Tap the Change destination button.
5. Select the folder where the backup is to be saved.
8. Look at the screen. A message will tell you when the backup is done.
Note: A message is shown on the screen if the backup cannot be done.
To restore data from a backup
Prerequisite: The latest backup
1. Make sure that there is a connection between the analyzer and the device that
contains the backup.
2. Tap Menu > Utilities > Disk functions > Restore all data.
3. Tap the Change source button.
204
4. Select the folder that contains the backup.

Note: When data is restored, the analyzer shuts down and restarts.
Saving and loading setups
To save the setup

1. Create a folder for the setup on the device on which the setup is to be saved.
2. Make sure that there is a connection between the analyzer and the device on
which the setup is to be saved.
3. Tap Menu > Utilities > Disk functions > Save setup.
4. Tap the Edit location button.
5. Select the folder where the setup is to be saved.
8. Wait until a message tells you that the setup is saved.
To load a setup
1. Make sure that there is a connection between the analyzer and the device from
which the setup is to be loaded.
2. Tap Menu > Utilities > Disk functions > Load setup.
Option Steps
To load all parts of the setup Select the All check box.
To load one or more parts of a) Deselect the All check box.

the setup b) Select the check boxes of the setups you
want to load.
4. Tap the Change source button.
5. Select the folder from which the setup is to be loaded.
Note: The analyzer will shut down and restart with the new setup.
To restore Radiometer default settings

1. Tap Menu > Utilities > Disk functions > Restore default setup.
Option Steps
To restore all default settings Select the All check box.
To restore one or more default a) Deselect the All check box.

settings b) Select the check boxes of the default
settings you want to restore.
Note: The analyzer will shut down and restart with the new setup.
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Radiometer default settings
Operators and profiles - default settings
Item Default setting
Operators Radiometer, Remote operator, Manager
Access profiles Service technician, Remote operator, Manager
Logoff time 3 minutes
Anonymous access enabled Yes
Access profile for anonymous operator User
Authenticate operator by Logon-barcode as primary
Access profile Access to activities
A B C D E F G H I J K L M
Operator X X X X X X X X X X X X
Supervisor X X X X X X X X X X X X X
Manager X X X X X X X X X X X X X
Service technician X X X X X X X X X X X X X
Guest X X X X X X X
Custom 1 X X X X X
Custom 2 X X X X X
Custom 3 X X X X X
Remote operator X X X X X X X X X X X X
Activity Description
A Perform measurements
B Perform calibrations
C Perform operator Activities
D Edit data in logs
E Perform built-in QC
F Approve results
G Replace the Sensor Cassette
H Clean the Inlet Gasket
I Replace the Inlet Gasket Holder
J Replace the Solution Pack
K Replace the Inlet Connector Gasket
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Activity Description
L Flush the analyzer
M Replace the Inlet Probe
Alarm sound (acoustic signal) settings for events - default settings
Event Default setting
Value exceeds critical range No
Close inlet Yes
Result is ready Yes
Inlet is open too long Yes
Language - default setting
Screen language English
Analysis setup – default settings
Analysis setup Default setting
Syringe sample modes • Syringe - S 65µL
Note: All user-defined modes are removed.
Capillary sample modes C 65µL
Note: All user-defined modes are removed.
Parameter profiles All parameters are selected.
Use dynamic parameters is off.
Sample pre-registration • Interpret barcode input as: Sampler ID

setup
• Included fields: Sampler ID, Patient first name, Patient last
name, Birth date, Patient sex, Accession no．
Sample age evaluation Enable calculation of sample age: Yes (30 minutes for all parame-
setup ters)
Patient report setup • Layouts: -R- Default

• Patient ID layout settings included in the -R- Default layout:
• Patient ID
• Patient last name
• Patient first name
• Sample type (Not specified)
• Temperature (T ), 37.0 °C
• Patient result settings included in the -R- Default layout (bold
text = a new title; [xxx - xxx] = the reference range for a
parameter)
207
Patient report setup Blood gas values
pH [xxx - xxx]
pCO2 [xxx - xxx]
pO2 [xxx - xxx]
<New line>
Oximetry values
ctHb [xxx - xxx]
sO2 [xxx - xxx]
FO2Hb [xxx - xxx]
FCOHb [xxx - xxx]
FHHb [xxx - xxx]
FMetHb [xxx - xxx]
FHbF [xxx - xxx]
<New line>
Electrolyte values
cK+ [xxx - xxx]
cNa+ [xxx - xxx]
cCa2+ [xxx - xxx]
cCl– [xxx - xxx]
<New line>
Metabolite values
cGlu [xxx - xxx]
cLac [xxx - xxx]
ctBil* [xxx - xxx]
<New page>
Temperature-corrected values
pH(T)
pCO2(T)
pO2(T)
<New group>
Oxygen status
ctO2
p50
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Patient report setup <New line>
Acid-base status
cBase(Ecf)
cHCO3–(P,st)
Parameters - default settings
The user-defined settings for Enabled and Locked are saved as the default settings.
No parameter is repressed by default.
Measured Units Offset Slope Out-of-range suppression

parameters
pH N/A 0.000 1.000 N/A
pCO2 mmHg 0.0 1.000 N/A
pO2 mmHg 0.0 1.000 N/A
ctHb g/dL N/A 1.000 No
sO2 % 0.0 1.000 No
FO2Hb % N/A N/A No
FCOHb % 0.0 N/A No
FMetHb % 0.0 N/A No
FHHb % N/A N/A No
FHbF % 0 1.000 Yes
cK+ mmol/L 0.0 1.000 N/A
cNa+ mmol/L 0 1.000 N/A
cCa2+ mmol/L 0.00 1.000 N/A
cCl- mmol/L 0 1.000 N/A
cGlu mmol/L 0.0 1.000 N/A
cLac mmol/L 0.0 1.000 N/A
ctBil* µmol/L 0 1.000 N/A
Measurement units - default settings
Items Default setting
Pressure mmHg
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Items Default setting
ctBil* µmol/L
ctHb g/dL
FCOHb %
FHbF %
FHHb %
FMetHb %
FO2Hb %
sO2 %
Gas fractions %
FO2(I) %
Hct %
pO2(a,A) %
FShunt %
RI %
cK+/cNa+/ cCl– mmol/L
cCa2+ mmol/L
cGlu mmol/L
cLac mmol/L
Temperature °C
ctO2 Vol %
ctCO2 Vol %
̇ 2
DO mL/min
̇ 2
VO mL/min
Age years
Weight kg
Height m
Altitude m
Birth weight g
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Calibration schedule - default settings
Calibration schedule setup Default setting
tHb calibration Interval: 3 months
First calibration starts at: 00:00
Link QC schedule with calibration schedule: Yes
Quality control setups - default settings
Setups Item Default setting
QC statistics Statistical factor used for value acceptance: 1.5
Automatically print QC statistics when lot changes: Yes
QC input setup Mandatory temperature: No
Default temperature: 25 °C
QC schedule Built-in QC solutions (S9030, S9040, S9050) 04:00, 12:00, 20:00

(daily)
Run built-in QCs after replacement and startup Yes
Westgard rules Use Westgard Evaluation: No
RiLiBÄK rules Use RiLiBÄK rules No
Replacement setups - default settings
Menu Item Default setting - interval
Replacement schedule setup Inlet Gasket Never
Inlet Probe Never
Connection gasket Never
Clean inlet Never
Operator activity schedule None –
Maintenance planning setup None –
Replacement warning setup Number of activities before 5

replacement warning:
Time before replacement 4 hours

warning:
Expected measurements per 10

day:
Note: – = There is no default setting.
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Communication setup - default settings
Item Default settings
RADIANCE connection Not enabled
LIS/HIS connection -
QA portal Not enabled
Automatic data request -
Automatic data transmission -
Patient lookup setup On the D:\ drive of the analyzer (local database)
Remote support Enable remote access: Yes
Note: - = There is no default setting.
User-defined patient data items - default settings
Note: All items have numerical values.
Item Unit Number of decimals
Spontaneous RR b/min 1
Set RR b/min 2
Vt L 2
Ve L 2
Peak flow L/min 1
Liter flow L/min 2
Ti seconds 1
PEEP cmH2O 1
Pressure support cmH2O 1
CPAP cmH2O 1
CMV Rate 1
SIMV Rate 1
Flow-by L/min 1
HFV Rate 1
I:E ratio – 2
Wave – –
ICD9 code – –
Oxygen device 1 – –
Oxygen device 2 – –
Diagnostic code – –
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Corrective actions – default settings
Event Default setting Traffic light color
Calibration error(s) present Do not run scheduled built-in Yellow

QC
Calibration schedule – Yellow

reminder(s)
QC error(s) present ? on specific parameters Yellow
QC schedule reminder(s) – Yellow
Replacement schedule – Yellow

reminder(s)
System message(s) present – Yellow
Operator activity reminder(s) – Yellow
Built-in QC error(s) present – Yellow
Miscellaneous setup - default settings
Analyzer locked Not enabled
Enable estimated derived parameters Not enabled
Fixed pO2/pCO2 decimals Not enabled
Enable general barcode support Enabled
Enable patient result approval Not enabled
Apply parameter corrections to QC Enabled
Log all measurement activities Not enabled
Auto temp unit conversion Not enabled
Enable screen saver Enabled
Show parameter bar Enabled
HbF correction Enabled for levels > 20 %
Analyzer message –
Enable screen saver (the time period the 5 minutes

analyzer must not be in use before the screen
saver is shown)
213
Printer setup - default settings
Installed printers The analyzer printer
Manual printing (to see and select a printer Off

from a list of the installed printers)
Automatic printing - default settings
Item Default settings
Patient results On
QC results Off
Calibration results Off
Activity log messages Off
Message level User
Number of copies (to print) 1
Automatic archiving - default settings
Patient results log On
Calibration log On
Quality control log On
Activity log On
Store archives on the analyzer On
Automatic backup - default setting
Automatic backup Off
Setups with no default settings
• User-defined notes
• Barometer setup
• Time and date setup
• Analyzer identification setup
214
References
1. Tietz, NW, Logan NM. Reference ranges, In: Tietz NW, ed. Fundamentals of clinical
chemistry: 3rd ed. Philadelphia: WB Saunders Company, 1987: 944-75.
2. Westgard JO, Barry PLL. Cost effective quality control: managing the quality and
productivity of analytical processes. Washington: AACC Press, 1992.
215
216
Performance characteristics 10
Measured parameters - definitions
Measured parameters are parameters measured by the analyzer. Parameter definitions

are shown in the table.
Measured Definition
parameters
pH Is a measure of the acidity or alkalinity of a sample
cH+ Concentration of hydrogen ions in blood
pCO2 Partial pressure (or tension) of carbon dioxide in blood
pO2 Partial pressure (or tension) of oxygen in blood
ctHb Concentration of total hemoglobin in blood
sO2 Oxygen saturation, the ratio between the concentrations of oxyhemoglobin and
the hemoglobin minus the dyshemoglobins
FO2Hb Fraction of oxyhemoglobin in total hemoglobin in blood
FCOHb Fraction of carboxyhemoglobin in total hemoglobin in blood
FMetHb Fraction of methemoglobin in total hemoglobin in blood
FHHb Fraction of deoxyhemoglobin in total hemoglobin in blood
FHbF Fraction of fetal hemoglobin in total hemoglobin in blood
cK+ Concentration of potassium ions in plasma
cNa+ Concentration of sodium ions in plasma
cCa2+ Concentration of calcium ions in plasma
cCl- Concentration of chloride ions in plasma
cGlu Concentration of D-glucose in plasma
cLac Concentration of L-lactate in plasma
ctBil Concentration of total neonatal bilirubin in plasma.
Bilirubin can only be measured on neonatal samples. This parameter is only avail-
217
Chapter 10: Performance characteristics ABL90 FLEX: Instructions for use
About performance characteristics
Overview of performance characteristics
The performance characteristics for parameters measured on the analyzer are based
on the results of performance tests [1]. A comparison is made between the ABL90
FLEX analyzer and the primary reference methods, as well as between the ABL90 FLEX
analyzer and the reference analyzer (the ABL735 analyzer).
The performance characteristics shown in the table below were calculated from the
results.
Performance charac- Definitions

teristics
BiasPrim.ref The mean difference between results obtained on the ABL90 FLEX
analyzer and those obtained with primary reference methods
BiasSec.ref The mean difference between results obtained on the ABL90 FLEX
analyzer and the ABL735 analyzer
S0 Repeatability (precision estimate)
Sx Reproducibility (precision estimate)
CV % Coefficient of variation
TEA Total analytical error
Uncertainty in performance characteristics
Performance characteristics of the analyzer are calculated from the results of perform-
ance tests. The results are subject to an uncertainty due to test conditions during the
performance tests. Uncertainty values as well as exact values are therefore given for
bias, S0, SX and TEA characteristics.
Performance Assumptions made in the calculation of uncertainty

characteristics
Bias Bias values are described by a normal distribution.
S0 S02 and Sx2, calculated from S0 and Sx values, is described by a

Chi-square distribution
Sx
TEA TEA is calculated from the bias and Sx
The given uncertainty values are calculated at a confidence interval of 68 %.
An uncertainty at a 68 % confidence interval, which corresponds to 1 SD, can be

converted into an uncertainty at other confidence intervals.
For bias, the uncertainty value at a 68 % confidence interval is given as a plus-minus

value (for example ±x.xxx). For S0 , SX and TEA the upper limit of the uncertainty
values at a 68 % confidence interval are given as plus values (for example +x.xxx).
Related information
To convert an uncertainty at a 68 % confidence level, page 219
218
ABL90 FLEX: Instructions for use Chapter 10: Performance characteristics
To convert an uncertainty at a 68 % confidence level
The table shows the factor you need to multiply uncertainties at a 68 % confidence
level with to convert them to uncertainties at a new confidence level.
New confidence level Multiplication factor
90 % 1.64
95 % 1.96
97.5 % 2.24
99 % 2.58
99.5 % 2.81
99.9 % 3.29
Example:
Uncertaintyat a 95 % confidence interval = Uncertaintyat a 68 % confidence interval × 1.96
Bias
The bias of a quantity is defined as the mean difference between the measured value
on a group of test instruments and the estimated true value (as assayed by the refer-
ence method or certified standard reference material). BiasPrim.ref was determined as
follows:
̄ BL90 FLEX - xP̄ rimary reference method/material

BiasPrim.ref = xA
BiasSec.ref is a relative bias between the ABL90 FLEX analyzer and the ABL735 analyzer
in macromode (C 195µL mode), and was determined as follows:
BiasSec.ref = x̄ABL90 FLEX - x̄ABL735
Bias values given in the performance test results were calculated from performance
test results. The uncertainty given with bias test results was calculated a 68 % confi-
dence level.
Note: The assumption was made that bias values are normally distributed.
BiasPrim.ref.
Prim.Ref. Sec.Ref. (ABL735) ABL90 FLEX

65 μL
BiasPrim.ref. BiasSec.ref.
Repeatability and reproducibility
Repeated measurements on one analyzer of samples that are assumed to be identical

will not necessarily give identical results. The degree of variation in the results is a
measure of the imprecision (under repeatability conditions) of the analyzer [2].
S0 and Sx values given in the performance test results were calculated from perform-
ance test results. The uncertainty given with bias test results was calculated a 68 %
confidence level.
219
Note: The assumption was made that S02 and Sx2, calculated from S0 and Sx values, is
described by a Chi-square distribution.
Performance Abbrevi- Description

characteristic ation
Repeatability S0 This is the standard deviation obtained from repeated measure-

ments within a short interval of time with:
• The same instrument and location
• The same measurement procedure
• Identical portions of the same sample
• One operator per analyzer
S0 for each level is pooled for all test analyzers and test days.
The repeatability is equal to S0.
Reproducibility Sx This is the standard deviation obtained from repeated measure-

ments over several days with:
• Random analyzer
• Random sample
• Random operators
The reproducibility for each level is calculated on the basis of all

test analyzers and test days.
The reproducibility is equal to Sx.
Coefficient of variation (CV %)
The coefficient of variation is reported as a percentage and calculated from the mean
(or measuring level) and standard deviation as follows:
S tan dard deviation

CV% = ´ 100
Measuring level
Confidence intervals
Confidence interval provides a range of values estimated from a study group that is
highly likely to include the true, but unknown, value. A confidence interval applies to
the results of a statistical analysis. A 95 % confidence interval means that there is only
a 5 % chance that the true value is not included in the interval.
Uncertainty values were calculated at a confidence level of 68 % for the bias, S0, SX
and TEA values given in the performance test results.
To calculate the uncertainty values at a confidence level of 95 %, multiply the uncer-

tainty values at a confidence level of 68 % by the factor 1.96.
At a pH level of 6.800, the uncertainty in the bias value at a 68 % confidence level =

±0.0050.
At a pH level of 6.800, the uncertainty in the bias value at a 95 % confidence level =

±0.0050 × 1.96 = ±0.0098.
Total analytical error
TEA , total analytical error is a quality specification that sets a limit for both the random
error (reproducibility) and systematic error (bias) in a single measurement or single
test result.
220
Total analytical error values given in the performance test results were calculated as
absolute numbers and percentages.
• The equation: TEA = (|Bias|+1.96×Sx), was used to calculate the absolute values
• The equation: TEA = (|Bias %|+1.96×CVx) %, was used to calculate the percentage
values
The uncertainty given with the TEA values is calculated from the uncertainty of the bias
and Sx values at a 68 % confidence level.
The equation used to calculate TEA defines a 95 % confidence interval (0 ±TEA) for the
total analytical error, when the TEA value is corrected with 2 times the uncertainty
given with the TEA value.
About performance tests
Test conditions
Test conditions to determine the performance characteristics for the measured parame-
ters were as follows:
Item Description
Reference analyzers Five ABL735 analyzers with AutoCheck module were used as a refer-
ence. The capillary mode was used for pCO2 and pO2, and the syringe
mode for all the other parameters.
Primary/secondary As specified for each parameter in this chapter

reference methods
Analyzers and test 8-10 analyzers were tested in 65 µL syringe and capillary modes.
modes
Blood samples Heparinized blood samples from healthy, voluntary donors. The blood
was prepared to obtain different concentration levels of each meas-
ured parameter.
Blood measurements Measurements on every parameter were done on all analyzers, with 5
measurements on every sample of each run, repeated for 3 days. The
measurements were done by different operators.
Solution Pack All calibration solutions and gases used for the tests are traceable to
Primary Reference Standards. Contact your local Radiometer repre-
sentative for traceability certificates for the ABL90 FLEX calibration
solutions and gases.
Experimental conditions Ambient temperature: 22-25 °C. Relative humidity: 30-50 %. Baro-
metric pressure: 730-780 mmHg
Note: The solutions used in performance tests are those recommended by Radiometer.
Performances using other solutions cannot be guaranteed. The performance tests are
done under conditions where the analyzers are not influenced by electromagnetic
fields.
221
Reference methods/materials
Param- Primary reference method/material Secondary refer- Reference

eter ence method
pH Capillary-type glass pH electrode with a satu- ABL735 analyzer [3,4]

rated calomel reference electrode and a liquid
junction saturated with KCl (BMS Mk2).
The calibration standards are traceable to the

Primary Reference Standards for pH.
pCO2 Tonometry. N/A [5]
The gases used for tonometry are traceable to

NIST-certified Standard Reference Materials.
pO2 Tonometry. N/A [5]
The gases used for tonometry are traceable to

NIST-certified Standard Reference Materials.
cCa2+ Calcium transfer standards were used. These are ABL735 analyzer The stand-
traceable to NIST SRM 915b and SRM 956b and ards were
have an ionic strength of 160.0 mmol per kg of produced
water and pH 7.40 at 37 °C, where 1 mmol/L as indi-
(37 °C) HEPES buffer was used. cated in
[6]
cCl– NIST-certified Standard Reference Material SRM ABL735 analyzer

909b human serum) and SRM 956b
cK+ NIST-certified Standard Reference Material SRM ABL735 analyzer

909b human serum) and SRM 956b
cNa+ NIST-certified Standard Reference Material SRM ABL735 analyzer

909b human serum), NIST 956b and
Radiometer-specified standard serum material
(specified using flame photometry)
cGlu Spectrophotometry which uses the hexokinase N/A [7]

(HK) method recommended by CLSI (formerly
NCCLS), measured on serum
cLac Spectrophotometry which uses a lactate dehy- N/A [8]

drogenase (LDH) method, measured on serum
ctHb HiCN method recommended by CLSI (formerly ABL735 analyzer [9]

NCCLS)
sO2 Tonometry: ABL735 analyzer
100%: blood is tonometered with a gas mixture

which contains 94.4% O2 and 5.6% CO2. 0%:
blood is tonometered with a gas mixture which
contains 94.4% N2 and 5.6% CO2 + dithionite.
FO2Hb Measured in accordance with the following rela- ABL735 analyzer

tion: FO2Hb = 1 - (FHHb + FCOHb + FMetHb)
FHHb 0%: blood is tonometered with a gas mixture ABL735 analyzer

which contains 94.4 % N2 and 5.6 % CO2 +
dithionite
FCOHb Gas chromatography: The Standards are carbon ABL735 analyzer

monoxide mixtures with atmospheric air, whose
purity is validated in accordance with NIST SRM
1678c (50 ppm CO in N2)
222
Param- Primary reference method/material Secondary refer- Reference

eter ence method
FMetHb Spectrometry, modified Evelyn-Malloy method ABL735 analyzer [10]
FHbF The reference method is based on Cation ABL735 analyzer [11]

Exchange HPLC
ctBil* The reference method for total bilirubin is a ABL735analyzer

spectrophotometric method (wet chemistry
based on a method from Bayer Healthcare,
Tarrytown USA).
The method is traceable to NIST SRM916a Bilir-

ubin.
General reference: [25].
Performance test results
Rounding rules
Normal rounding rules are used to round off all the values given in the performance
test results tables.
pH performance test results
BiasPrim‧ref for pH
pH BiasPrim‧ref N (number of samples analyzed)
7.0 –0.0030 45
7.4 0.0020 45
7.6 0.0010 45
BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref
65 µL: Performance characteristics for pH – blood samples
pH Value and uncertainty BiasSec.ref S0 Sx TEA
6.800 Value –0.0300 0.0014 0.0067 0.0431
Uncertainty ±0.0046 +0.0001 +0.0004 +0.0053
7.000 Value –0.0120 0.0012 0.0057 0.0232
Uncertainty ±0.0046 +0.0001 +0.0001 +0.0049
7.200 Value –0.0090 0.0025 0.0061 0.0210
Uncertainty ±0.0046 +0.0002 +0.0001 +0.0049
7.400 Value –0.0030 0.0015 0.0067 0.0162
Uncertainty ±0.0046 +0.0001 +0.0003 +0.0052
7.800 Value –0.0040 0.0021 0.0122 0.0278
223
65 µL: Performance characteristics for pH – blood samples
pH Value and uncertainty BiasSec.ref S0 Sx TEA
7.800 Uncertainty ±0.0065 +0.0002 +0.0013 +0.0091
pCO2 performance test results
65 µL: Performance characteristics for pCO2 – blood samples
pCO2 Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty
15.0 Value 0.14 0.16 0.70 4.7 1.52 10.1
Uncertainty ±0.14 +0.01 +0.06 - +0.27 -
40.0 Value 0.18 0.25 0.56 1.4 1.27 3.2
Uncertainty ±0.12 +0.02 +0.03 - +0.18 -
60.0 Value –0.21 0.29 0.87 1.5 1.92 3.2
Uncertainty ±0.22 +0.02 +0.10 - +0.41 -
80.0 Value –0.38 0.23 1.45 1.8 3.22 4.0
Uncertainty ±0.29 +0.02 +0.18 - +0.64 -
100 Value –0.91 0.90 2.38 2.4 5.58 5.6
Uncertainty ±0.44 +0.06 +0.22 - +0.86 -
- = not applicable
pO2 performance test results
65 µL: Performance characteristics for pO2 - blood samples
pO2 Value and BiasPrim‧ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty
30.0 Value –0.39 0.35 0.73 2.4 1.8 6.1
Uncertainty ±0.15 +0.02 +0.10 - +0.4 -
75.0 Value 0.47 0.25 0.67 0.9 1.8 2.4
Uncertainty ±0.22 +0.02 +0.05 - +0.3 -
125 Value 0.8 0.5 1.2 1.0 3.2 2.5
Uncertainty ±0.4 +0.0 +0.1 - +0.6 -
250 Value 0.4 1.8 2.9 1.2 6.1 2.5
Uncertainty ±0.7 +0.1 +0.2 - +1.0 -
500 Value 4.9 3.8 6.0 1.2 16.6 3.3
Uncertainty ±1.4 +0.2 +0.3 - +2.0 -
- = not applicable
224
cK+ performance test results
Bias Prim‧ref for cK+
cK+ (mmol/L / mEq/L) BiasPrim‧ref N (number of samples analyzed)
2.0 –0.04 45
4.0 0.00 45
6.0 0.01 45
65 µL: Performance characteristics for cK+ - blood samples
cK+ Value and BiasSec‧ref S0 Sx CVX % TEA TEA(%)

(mmol/L / mEq/L) uncertainty
2.0 Value –0.10 0.04 0.09 4.3 0.27 13.4
Uncertainty ±0.07 +0.00 +0.00 - +0.08 -
4.0 Value –0.01 0.03 0.08 2.0 0.17 4.2
Uncertainty ±0.07 +0.00 +0.00 - +0.07 -
6.0 Value 0.04 0.03 0.10 1.7 0.24 4.0
Uncertainty ±0.08 +0.00 +0.01 - +0.10 -
8.0 Value 0.07 0.03 0.12 1.5 0.30 3.7
Uncertainty ±0.09 +0.00 +0.01 - +0.11 -
10.0 Value 0.10 0.04 0.12 1.2 0.34 3.4
Uncertainty ±0.09 +0.00 +0.01 - +0.11 -
- = not applicable
cNa+ performance test results
65 µL: Performance characteristics for cNa+ - blood samples
cNa+ Value and BiasPrim.ref* S0 Sx CVX % TEA TEA(%)

120 Value 0.5 0.3 1.0 0.8 2.4 2.0
Uncertainty ±0.8 +0.0 +0.1 - +0.9 -
130 Value 0.8 0.3 1.1 0.8 2.9 2.2
Uncertainty ±0.8 +0.0 +0.1 - +1.0 -
140 Value 0.6 0.3 1.1 0.8 2.7 1.9
Uncertainty ±0.8 +0.0 +0.1 - +1.0 -
160 Value 1.0 0.4 1.2 0.7 3.3 2.0
Uncertainty ±0.9 +0.0 +0.0 - +1.0 -
180 Value 0.7 0.4 1.4 0.8 3.5 1.9
225
65 µL: Performance characteristics for cNa+ - blood samples
cNa+ Value and BiasPrim.ref* S0 Sx CVX % TEA TEA(%)

180 Uncertainty ±1.0 +0.0 +0.1 - +1.2 -
* The ABL735 measurements are corrected to the primary reference method through
this equation: NaABL735, corrected = 1.055 × NaABL735, measured – 6.8966 (mmol/L)
- = not applicable
Related information
Reference methods/materials, page 222
cCl– performance test results
BiasPrim.ref for cCl–
cCl– (mmol/L / mEq/L) BiasPrim.ref N (number of samples analyzed)
89 –1.5 45
119 2.1 45
65 µL: Performance characteristics for cCl– - blood samples
cCl– Value and BiasSec.ref S0 Sx CVX % TEA TEA(%)

80 Value –1.1 0.3 1.0 1.2 3.1 3.8
Uncertainty ±0.7 +0.0 +0.1 - +0.8 -
100 Value –1.1 0.3 1.2 1.2 3.5 3.4
Uncertainty ±0.8 +0.0 +0.0 - +0.9 -
120 Value –1.4 0.3 1.4 1.2 4.2 3.5
Uncertainty ±0.9 +0.0 +0.0 - +1.0 -
140 Value –1.4 0.3 2.2 1.6 5.7 4.1
Uncertainty ±1.0 +0.0 +0.2 - +1.4 -
150 Value –1.4 0.4 2.1 1.4 5.5 3.7
Uncertainty ±1.1 +0.0 +0.0 - +1.2 -
- = not applicable
cCa2+ performance test results
BiasPrim.ref for cCa2+
cCa2+ (mg/dL) BiasPrim.ref N (number of samples analyzed)
1.98 0.060 45
4.93 0.144 45
226
BiasPrim.ref for cCa2+
cCa2+ (mg/dL) BiasPrim.ref N (number of samples analyzed)
10.02 -0.100 45
65 µL: Performance characteristics for cCa2+ - blood samples
cCa2+ Value and BiasSec.ref S0 Sx CVX % TEA TEA(%)

(mg/dL) uncertainty
2.00 Value -0.184 0.006 0.073 3.6 0.327 16.3
Uncertainty ±0.032 +0.000 +0.008 - +0.048 -
3.00 Value -0.080 0.007 0.082 2.7 0.241 8.0
Uncertainty ±0.032 +0.000 +0.010 - +0.052 -
5.00 Value 0.004 0.012 0.073 1.5 0.148 3.0
Uncertainty ±0.032 +0.001 +0.005 - +0.043 -
7.00 Value 0.048 0.019 0.101 1.4 0.246 3.5
Uncertainty ±0.064 +0.001 +0.002 - +0.068 -
10.00 Value -0.152 0.034 0.187 1.9 0.519 5.2
Uncertainty ±0.140 +0.002 +0.002 - +0.143 -
- = not applicable
cGlu performance test results
65 µL: Performance characteristics for cGlu in blood with a pO2 ≥90 mmHg
cGlu Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mg/dL) uncertainty
5 Value 0.6 0.4 1.5 30.5 3.5 70.8
Uncertainty ±1.1 +0.4 +0.2 - +1.4 -
36 Value –1.6 0.5 1.7 4.6 4.9 13.6
Uncertainty ±1.1 +0.6 +0.1 - +1.4 -
108 Value –1.3 1.1 2.9 2.7 7.0 6.5
Uncertainty ±1.1 +1.4 +0.3 - +1.7 -
180 Value 4.1 1.6 4.2 2.4 12.5 6.9
Uncertainty ±1.1 +2.0 +0.5 - +2.2 -
450 Value –15.7 3.3 14.9 3.3 44.9 10.0
Uncertainty ±3.3 +3.9 +2.2 - +7.6 -
720 Value –28.5 9.4 41.9 5.8 110.6 15.4
Uncertainty ±9.2 +11.3 +8.7 - +26.2 -
227
- = not applicable
65 µL: Performance characteristics for cGlu in blood with 25 mmHg ≤ pO2 <90 mmHg
cGlu Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mg/dL) uncertainty
5 Value –0.08 0.4 2.0 39.5 4.6 92.4
Uncertainty ±1.1 +0.4 +0.4 - +1.9 -
36 Value 2.5 0.4 1.7 4.8 5.9 16.3
Uncertainty ±1.1 +0.5 +0.1 - +1.4 -
108 Value 3.9 0.9 4.0 3.7 11.7 10.8
Uncertainty ±1.5 +1.1 +0.2 - +1.8 -
180 Value 4.8 1.8 7.4 4.1 19.3 10.7
Uncertainty ±2.1 +2.2 +0.6 - +3.3 -
450 Value –6.4 4.5 24.8 5.5 55.0 12.2
Uncertainty ±6.7 +5.4 +2.4 - +11.5 -
720 Value –47.5 13.3 56.8 7.9 158.8 22.1
Uncertainty ±14.5 +16.1 +8.1 - +30.3 -
- = not applicable
65 µL: Performance characteristics for cGlu in blood with 10 mmHg < pO2 <25 mmHg
cGlu Value and uncertainty BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mg/dL)
9 Value –1.1 0.3 1.3 14.0 3.5 39.4
Uncertainty ±1.1 +0.4 +0.0 - +1.2 -
36 Value –1.4 0.5 2.1 5.8 5.5 15.4
Uncertainty ±1.1 +0.6 +0.2 - +1.6 -
108 Value 2.9 1.5 5.0 4.6 12.7 11.7
Uncertainty ±1.2 +1.8 +1.0 - +3.1 -
180 Value 2.2 2.5 7.4 4.1 16.6 9.2
Uncertainty ±1.8 +3.0 +0.8 - +3.4 -
270 Value –17.7 3.6 15.9 5.9 48.9 18.1
Uncertainty ±3.2 +4.3 +3.0 - +9.2 -
- = not applicable
228
pO2 levels - how they affect cGlu results
WARNING – Risk of incorrect results

Low pO2 levels can have an effect on the linearity of glucose measurements. This can
lead to incorrect low glucose results. Please note that cGlu linearity is not specified
when the pO2 level is less than 10 mmHg (1.3 kPa).
pO2 levels in a sample cGlu linearity is specified in the range
mmHg kPa
<10 <1.3 Linearity not specified. The cGlu value is not usable.
If pO2 <10 mmHg (<1.3 kPa), the cGlu value is not usable and no
value is shown.
Analyzer message no. 1387 “Glu not usable” tells you that the
cGlu value is not usable.
10 ≤pO2 <25 1.3 ≤pO2 The cGlu value is shown if the cGlu value is <15 mmol/L (<270
<3.3 mg/dL).
If the cGlu value is >15 mmol/L (>270 mg/dL), the cGlu value is
shown as “>15” and analyzer message no. 1402 tells you that the
cGlu linearity is out of range.
≥25 ≥3.3 The entire reportable range.
cLac performance test results
65 µL: Performance characteristics for cLac in blood with a pO2 ≥90 mmHg
cLac Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mg/dL) uncertainty
3 Value 0.3 0.3 0.8 25.7 1.8 59.3
Uncertainty ±0.5 +0.0 +0.1 - +0.7 -
9 Value 0.3 0.5 1.2 12.9 2.5 28.3
Uncertainty ±0.6 +0.0 +0.2 - +0.9 -
45 Value 0.8 0.7 2.0 5.8 4.8 13.8
Uncertainty ±0.6 +0.1 +0.4 - +1.4 -
90 Value 1.7 1.0 6.9 7.7 15.3 17.0
Uncertainty ±1.1 +0.1 +2.0 - +4.9 -
135 Value 2.6 1.0 8.3 6.1 18.8 13.9
Uncertainty ±3.1 +0.1 +1.6 - +6.2 -
225 Value 0.5 2.2 20.9 9.3 41.5 18.4
Uncertainty ±5.8 +0.2 +4.5 - +14.7 -
- = not applicable
229
65 µL: Performance characteristics for cLac in blood with a pO2 <90 mmHg
cLac Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mg/dL) uncertainty
3 Value 0.3 0.3 0.8 25.7 1.8 59.3
Uncertainty ±0.5 +0.0 +0.1 - +0.7 -
9 Value 0.3 0.4 0.9 9.5 2.0 21.7
Uncertainty ±0.6 +0.0 +0.1 - +0.7 -
45 Value 0.8 0.9 3.0 8.5 6.7 19.0
Uncertainty ±0.6 +0.1 +0.7 - +2.0 -
90 Value –0.5 0.8 7.1 7.9 14.3 15.9
Uncertainty ±1.5 +0.1 +1.7 - +4.8 -
135 Value –0.1 0.9 10.5 8.0 20.7 15.3
Uncertainty ±3.3 +0.1 +2.1 - +7.5 -
225 Value –11.4 1.9 24.3 10.8 59.1 26.3
Uncertainty ±7.3 +0.2 +4.0 - +15.2 -
- = not applicable
ctHb performance test results
Setup: Adult blood samples. HbF correction is not enabled.
65 µL: Performance characteristics for ctHb – blood samples
ctHb sO2 (%) Value and BiasPrim.ref* S0 SX CVX % TEA TEA

(g/dL) uncertainty (%)
0.00 Undefined Value –0.020 0.010 0.020 - 0.060 -
Uncertainty ±0.003 +0.001 +0.004 - +0.010 -
3.5 100 Value 0.02 0.05 0.08 2.4 0.19 5.3
Uncertainty ±0.04 +0.00 +0.00 - +0.05 -
7.0 100 Value 0.05 0.09 0.17 2.4 0.37 5.3
Uncertainty ±0.07 +0.01 +0.01 - +0.09 -
10.0 100 Value 0.06 0.08 0.20 2.0 0.45 4.5
Uncertainty ±0.09 +0.01 +0.01 - +0.12 -
15.0 100 Value 0.06 0.08 0.25 1.6 0.54 3.6
Uncertainty ±0.12 +0.01 +0.02 - +0.16 -
20.0 100 Value 0.00 0.09 0.30 1.5 0.58 2.9
Uncertainty ±0.14 +0.01 +0.02 - +0.19 -
25.0 100 Value 0.08 0.11 0.37 1.5 0.80 3.2
230
65 µL: Performance characteristics for ctHb – blood samples
ctHb sO2 (%) Value and BiasPrim.ref* S0 SX CVX % TEA TEA

25.0 100 Uncertainty ±0.18 +0.01 +0.04 - +0.25 -
* The ABL735 measurements are corrected to the primary reference method through
this equation:
ABL735 HICNcorrected: ctHbABL735, corrected = -0.000707 × (ctHbABL735, measured)2 +

0.9977 × ctHbABL735, measured (g/dL)
- = not applicable
Related information
sO2 performance test results
Setup: Adult blood samples. HbF correction not enabled.
BiasPrim.ref for sO2
sO2 (%) ctHb BiasPrim.ref N (number of

(g/dL) samples analyzed)
0.0 15 0.07 150
100.0 15 0.23 150
100.0 7 0.46 150
100.0 25 0.00 148
65 µL: Performance characteristics for sO2 – blood samples
sO2 (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

0.0 15 Value 0.09 0.08 0.26 - 0.59 -
Uncertainty ±0.20 +0.01 +0.01 - +0.23 -
50.0 15 Value –0.26 0.24 0.40 0.8 1.05 2.1
Uncertainty ±0.30 +0.02 +0.01 - +0.32 -
65.0 15 Value –0.20 0.27 0.46 0.7 1.11 1.7
Uncertainty ±0.30 +0.02 +0.03 - +0.37 -
75.0 15 Value –0.10 0.30 0.48 0.6 1.05 1.4
Uncertainty ±0.30 +0.02 +0.03 - +0.35 -
90.0 15 Value –0.10 0.19 0.36 0.4 0.80 0.9
Uncertainty ±0.21 +0.01 +0.05 - +0.30 -
100.0 15 Value –0.07 0.09 0.29 0.3 0.64 0.6
Uncertainty ±0.17 +0.01 +0.06 - +0.28 -
231
65 µL: Performance characteristics for sO2 – blood samples
sO2 (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

100.0 7 Value 0.45 0.11 0.37 0.4 1.17 1.2
Uncertainty ±0.16 +0.01 +0.09 - +0.33 -
100.0 25 Value –0.53 0.09 0.28 0.3 1.08 1.1
Uncertainty ±0.16 +0.01 +0.06 - +0.27 -
- = not applicable
FO2Hb performance test results
65 µL: Performance characteristics for FO2Hb – blood samples
FO2Hb ctHb (g/dL) Value and BiasSec.ref So SX CVX % TEA TEA

(%) uncertainty (%)
0.0 15 Value 0.07 0.08 0.26 - 0.57 -
Uncertainty ±0.20 +0.01 +0.01 - +0.23 -
50.0 15 Value –0.25 0.27 0.58 1.2 1.38 2.8
Uncertainty ±0.31 +0.02 +0.06 - +0.42 -
65.0 15 Value –0.43 0.30 0.48 0.7 1.37 2.1
Uncertainty ±0.32 +0.02 +0.01 - +0.35 -
75.0 15 Value –0.27 0.35 0.55 0.7 1.35 1.8
Uncertainty ±0.33 +0.02 +0.03 - +0.40 -
90.0 15 Value –0.23 0.23 0.40 0.4 1.02 1.1
Uncertainty ±0.27 +0.02 +0.04 - +0.33 -
100.0 15 Value –0.10 0.16 0.38 0.4 0.85 0.9
Uncertainty ±0.24 +0.01 +0.06 - +0.35 -
100.0 7 Value –0.09 0.19 0.48 0.5 1.03 1.0
Uncertainty ±0.25 +0.01 +0.09 - +0.43 -
100.0 25 Value –0.45 0.18 0.53 0.5 1.50 1.5
Uncertainty ±0.26 +0.01 +0.13 - +0.52 -
- = not applicable
FCOHb performance test results
Setup: Adult arterial blood samples. HbF correction is not enabled.
232
BiasPrim.ref for FCOHb
FCOHb (%) ctHb (g/dL) BiasPrim.ref N (number of samples analyzed)
0.0 15 0.41 45
20.0 15 –0.01 45
65 µL: Performance characteristics for FCOHb – blood samples
FCOHb (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

0.0 15 Value 0.00 0.08 0.24 - 0.46 -
Uncertainty ±0.16 +0.01 +0.04 - +0.23 -
5.0 15 Value 0.08 0.08 0.26 5.1 0.58 11.7
Uncertainty ±0.20 +0.01 +0.03 - +0.26 -
10.0 15 Value 0.04 0.07 0.34 3.4 0.71 7.1
Uncertainty ±0.30 +0.00 +0.02 - +0.35 -
20.0 15 Value 0.11 0.08 0.67 3.4 1.43 7.1
Uncertainty ±0.65 +0.01 +0.01 - +0.67 -
30.0 15 Value 0.17 0.08 0.68 2.3 1.50 5.0
Uncertainty ±0.65 +0.01 +0.02 - +0.69 -
50.0 15 Value 0.30 0.09 0.68 1.4 1.63 3.3
Uncertainty ±0.65 +0.01 +0.01 - +0.68 -
99.0 15 Value 0.54 0.12 0.72 0.7 1.96 2.0
Uncertainty ±0.66 +0.01 +0.04 - +0.74 -
- = not applicable
FMetHb performance test results
BiasPrim.ref for FMetHb
FMetHb (%) ctHb (g/dL) BiasPrim.ref N (number of samples analyzed)
0.0 15 0.23 45
20.0 15 –0.13 45
65 µL: Performance characteristics for FMetHb – blood samples
FMetHb (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

0.0 15 Value -0.04 0.10 0.23 - 0.50 -
233
65 µL: Performance characteristics for FMetHb – blood samples
FMetHb (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

0.0 15 Uncertainty ±0.11 +0.01 +0.05 - +0.20 -
5.0 15 Value 0.02 0.09 0.26 5.1 0.52 10.4
Uncertainty ±0.16 +0.01 +0.04 - +0.23 -
10.0 15 Value –0.04 0.12 0.34 3.4 0.70 7.0
Uncertainty ±0.15 +0.01 +0.07 - +0.29 -
20.0 15 Value –0.18 0.09 0.27 1.4 0.72 3.6
Uncertainty ±0.20 +0.01 +0.03 - +0.26 -
30.0 15 Value –0.26 0.09 0.34 1.1 0.92 3.1
Uncertainty ±0.30 +0.01 +0.01 - +0.33 -
50.0 15 Value –0.21 0.09 0.43 0.9 1.05 2.1
Uncertainty ±0.40 +0.01 +0.01 - +0.42 -
99.0 15 Value 0.11 0.06 0.62 0.6 1.32 1.3
Uncertainty ±0.60 +0.00 +0.01 - +0.62 -
- = not applicable
FHHb performance test results
65 µL: Performance characteristics for FHHb – blood samples
FHHb ctHb (g/dL) Value and BiasSec.ref S0 Sx CVX % TEA TEA

(%) uncertainty (%)
0.0 15 Value 0.07 0.10 0.28 - 0.61 -
Uncertainty ±0.17 +0.01 +0.05 - +0.27 -
10.0 15 Value 0.08 0.18 0.36 3.6 0.78 7.8
Uncertainty ±0.21 +0.01 +0.05 - +0.31 -
25.0 15 Value 0.05 0.30 0.48 1.9 1.00 4.0
Uncertainty ±0.30 +0.02 +0.03 - +0.35 -
35.0 15 Value 0.08 0.27 0.50 1.4 1.06 3.0
Uncertainty ±0.31 +0.02 +0.05 - +0.40 -
50.0 15 Value 0.11 0.26 0.57 1.1 1.23 2.5
Uncertainty ±0.31 +0.02 +0.05 - +0.42 -
100.0 15 Value -0.14 0.16 0.40 0.4 0.92 0.9
Uncertainty ±0.27 +0.01 +0.03 - +0.34 -
234
65 µL: Performance characteristics for FHHb – blood samples
FHHb ctHb (g/dL) Value and BiasSec.ref S0 Sx CVX % TEA TEA

(%) uncertainty (%)
0.0 7 Value -0.45 0.13 0.36 - 1.16 -
Uncertainty ±0.16 +0.01 +0.08 - +0.32 -
0.0 25 Value 0.53 0.09 0.26 - 1.04 -
Uncertainty ±0.16 +0.01 +0.05 - +0.25 -
- = not applicable
FHbF performance test results
Setup: Mixed adult and fetal blood samples. HbF correction enabled for all levels.
65 µL: Performance characteristics for FHbF - blood samples
FHbF ctHb (g/dL) Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)
(%) uncertainty
20 15 Value 1.1 1.8 3.6 18.0 8.2 40.8
Uncertainty ±0.8 +0.1 +0.6 - +2.0 -
30 15 Value –1.7 1.8 4.3 14.2 10.0 33.5
Uncertainty ±1.2 +0.1 +1.0 - +3.1 -
50 15 Value –3.1 1.6 3.9 7.8 10.7 21.5
Uncertainty ±1.8 +0.1 +0.6 - +2.7 -
80 15 Value –4.2 1.8 4.1 5.1 12.2 15.2
Uncertainty ±2.8 +0.1 +0.3 - +3.3 -
The ABL735 measurements are corrected to the primary reference method through this
equation:
FHbFABL735, corrected = FHbFABL735, measured - 0.9 × ctHb + 11.7 (%)
- = not applicable
Related information
ctBil* performance test results
Setup: HbF correction is enabled for all levels.
ctBil* ctHb Value and BiasSec.ref S0 SX CVX% TE A TE A

(mg/dL) (g/dL) uncertainty (%)
2.0 18 Value –0.44 0.16 0.55 27.0 1.51 75.0
Uncertainty ±0.16 0.01 0.16 - 0.47 -
5.8 18 Value –0.39 0.19 0.59 10.2 1.54 26.4
Uncertainty ±0.23 0.01 0.15 - 0.52 -
235
ctBil* ctHb Value and BiasSec.ref S0 SX CVX% TE A TE A

(mg/dL) (g/dL) uncertainty (%)
11.7 18 Value – 0.57 0.20 0.69 5.9 1.93 16.5
Uncertainty ±0.36 0.01 0.16 - 0.68 -
23.4 18 Value – 0.89 0.30 0.95 4.1 2.75 11.7
Uncertainty ±0.50 0.02 0.18 - 0.86 -
35.1 18 Value – 0.84 0.36 1.23 3.5 3.26 9.3
Uncertainty ±0.73 0.02 0.23 - 1.19 -
in the Neonate blood analysis 65 µL mode.
NOTES: a. Umbilical cord blood, pH = 7.4 ± 0.1. Spiked with unconjugated bilirubin.
Linearity study - study design
Linearity study
The linearity study was done according to NCCLS "Evaluation of the Linearity of Quanti-
tative Measurement Procedures: A Statistical Approach; Approved Guideline. NCCLS
document EP6, 2003".
Tests on each parameter were done with one analyzer, for one day, on a minimum of 7
levels (except for calcium, where only 6 levels were available) and 2 replicates per
level were done.
The study was an in-house study. Test material was:

• whole blood for pH, blood gases, electrolytes except calcium and co-oximetry
parameters
• cord blood, adjusted to mimic neonatal blood for ctBil* (ctHb~18 g/dL;~100 %
sO2).
• standards for calcium
• serum pools for glucose and lactate
Where whole blood was used as test material, the true values of the test material were
established according to the reference methods shown in this manual.
Linearity study - results
For each parameter the ABL90 FLEX results were analyzed for linearity.
For all parameters first, second and third order behaviour was investigated. Where
significant, second and/or third order behaviour was seen, linearity was verified to be
within pre-established limits for permitted error because of non-linearity.
236
Graphical presentation of test results and first order models
237
238
239
240
241
Interference test results
Interference tests
Interfering substances were selected for the interference tests. The selection was
based on previous knowledge and where interference was thought to be possible.
Interference can be caused by these factors:
• chemical structure
• decomposition
• optical properties
• other properties that are relevant to take into account as given in [21].
Interference limits were selected for all parameters. The interference limit is the
concentration of the interfering substance that was used for the interference tests. The
tests used parameters at their normal physiological levels.
To determine the degree of interference, test results for a sample with and without an
added interferent were compared. The results from the interference tests are given as
the deviation from the correct result [22].
pH/blood gas
These interference results are found for pH and blood gases:
242
Substance Test concen- Interference on ... Test matrix

tration
pH (at pH pCO2 mmHg pO2 mmHg
~ 7.4) (at 30-60 (at <100
mmHg) mmHg)
Ca2+ 5.5 mmol/L <|0.010| N/A N/A Blood
11 mEq/L
22 mg/dL
Fluorescein 400 mg/L N/A N/A <|1| Blood
Hemolysis 2% <|0.010| <|0.5| <|1| Blood
5% <|0.010| <|0.5| <|1| Blood
10 % <|0.010| <|0.5| <|1| Blood
20 % <|0.010| <|0.5| -1.50 Blood
Intralipid 2 % (400 <|0.010| <|0.5| <|1| Blood/aqueous

mg/dL)
5 % (1000 <|0.010| <|0.5| <|1| Blood/aqueous

mg/dL)
K+ 17 mmol/L / <|0.010| N/A N/A Blood

mEq/L
Na+ 190 mmol/L / <|0.010| N/A N/A Blood

mEq/L
Bilirubin (conj) 400 µmol/L <|0.010| <|0.5| <|1| Blood
23.4 mg/dL
Bilirubin 500 µmol/L <|0.010| <|0.5| <|1| Blood

(unconj)
29.2 mg/dL
N/A: Interference has not been measured on the respective parameter.
Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.
Electrolytes
These interference results are found for the electrolytes:
Substance Test Interference on ... Test matrix

concentra-
tion cK+ (at 4 cNa+ (at cCa2+ (at cCl– (at
mEq/L) 140 5 105
mEq/L) mg/dL) mEq/L)
Acetylsalicylic 0.91 N/A N/A N/A <|1| Plasma

acid mmol/L
0.16 g/L
1.21 N/A N/A N/A <|1| Plasma

mmol/L
0.22 g/L
243

concentra-
mEq/L) 140 5 105
Acetylsalicylic 1.81 N/A N/A N/A 1.1 Plasma

acid mmol/L
0.33 g/L
3.62 N/A N/A N/A 3.0 Plasma

mmol/L
0.65 g/L
Acetyl-trypto- 0.12 N/A N/A N/A <|1| Plasma

phane mmol/L
0.03 g/L
Ammonium 1 mmol/L <|0.1| <|1| N/A 1.1 Plasma

(NH4+) (1.7 mg/dL)
107 µmol/L <|0.1| <|1| N/A <|1| Plasma

(0.18
mg/dL)
Ascorbic acid 170 µmol/L N/A N/A N/A <|1| Plasma
0.03 g/L
850 µmol/L N/A N/A N/A <|1| Plasma
0.15 g/L
Benzalkonium 7.5 µg/mL 0.27 8.7 0.552 <|1| Plasma

chloride
10 µg/mL 0.39 12.1 0.728 <|1| Plasma
15 µg/mL 0.60 18.8 1.076 <|1| Plasma
30 µg/mL 1.28 40.4 2.488 <|1| Plasma
Bilirubin (conj) 400 µmol/L <|0.1| 1.31 <|0.08| <|1| Blood
23.4 mg/dL
Bilirubin 500 µmol/L <|0.1| <|1| <|0.08| 1.01 Blood

(unconj)
29.2 mg/dL
Bromide (Br–) 37.5 N/A N/A N/A 76.6 Plasma

mmol/L /
mEq/L

mmol/L /
mEq/L
10 N/A N/A N/A 19.5 Plasma

mmol/L /
mEq/L
5 mmol/L / N/A N/A N/A 10.1 Plasma

mEq/L
244

concentra-
mEq/L) 140 5 105
Bromide (Br–) 1 mmol/L / N/A N/A N/A 1.8 Plasma

mEq/L
Calcium (Ca2+) 3.4 mmol/L <|0.1| 1.2 N/A N/A Plasma
6.8 mEq/L
13.6 mg/dL
2.2 mmol/L N/A <|1| N/A N/A Plasma
4.4 mEq/L
8.8 mg/dL
3.6 mEq/L
7.2 mg/dL
3.2 mEq/L
6.4 mg/dL
Caprylic acid 0.12 N/A N/A N/A <|1| Plasma

mmol/L
0.017 g/L
Citrate 1 mmol/L N/A N/A N/A <|1| Plasma
0.19 g/L
40 mmol/L N/A N/A N/A –4.9 Plasma
7.7 g/L
Fluoride (F–) 107 N/A N/A N/A <|1| Plasma

µmol/L /
mEq/L
1 mmol/L / N/A N/A N/A <|1| Plasma

mEq/L
Hemolysis 2% 1.32 -2.35 -0.340 1.57 Blood
5% 3.63 -5.16 -0.636 2.27 Blood
10 % 6.77 -8.56 -0.928 1.20 Blood
20 % 12.68 -15.14 -1.488 <|1| Blood
Intralipid 2 % (400 <|0.1| <|1| <|0.08| <|1| Plasma

mg/dL)
5 % (1000 <|0.1| 2.4 <|0.08| 1.7 Plasma

mg/dL)
245

concentra-
mEq/L) 140 5 105
Iodide (I–) 2.99 N/A N/A N/A 12.4 Plasma

mmol/L /
mEq/L

mmol/L /
mEq/L
1 mmol/L / N/A N/A N/A 3.5 Plasma

mEq/L

mmol/L /
mEq/L
Lactate 25 mmol/L N/A N/A N/A <|1| Plasma
225 mg/dL
Lithium (Li+) 3.2 <|0.1| <|1| <|0.08| N/A Plasma

mmol/L /
mEq/L
Magnesium 15 mmol/L N/A <|1| –0.092 N/A Aqueous

(Mg2+)
30 mEq/L
<14 N/A <|1| <|0.08| N/A Aqueous

mmol/L
<28 mEq/L
Oxalate 1 mmol/L N/A N/A N/A <|1| Plasma
0.09 g/L
10 mmol/L N/A N/A N/A <|1| Plasma
0.9 g/L
Perchlorate 0.375 N/A N/A N/A 2.1 Plasma

(ClO4–) mmol/L /
mEq/L

mmol/L /
mEq/L

mmol/L /
mEq/L
1.5 N/A N/A <|0.08| 7.3 Plasma

mmol/L /
mEq/L
pH 6.8-8 N/A N/A –0.148 N/A Aqueous/plasma

mg/dL /
pH
N/A N/A N/A <|1| Plasma
246

concentra-
mEq/L) 140 5 105
Potassium 12 N/A <|1| <|0.08| N/A Plasma

mmol/L /
(K+) mEq/L
Salicylic acid 1.09 N/A N/A N/A <|1| Plasma

mmol/L
0.15 g/L
1.45 N/A N/A N/A <|1| Plasma

mmol/L
0.2 g/L

mmol/L
0.3 g/L

mmol/L
0.6 g/L
Sodium (Na+) 180 N/A N/A 0.116 N/A Plasma

mmol/L /
mEq/L
Strontium 150 µmol/L N/A N/A <|0.08| N/A Plasma

(Sr2+)
300 μEq/L
Thiocyanic acid 0.43 N/A N/A N/A 4.8 Plasma

mmol/L
0.025 g/L

mmol/L
0.033 g/L

mmol/L
0.05 g/L

mmol/L
0.1 g/L
Zinc (Zn2+) 170 µmol/L <|0.1| <|1| 0.096 N/A Plasma
1111 μg/d
Metabolites
These interference results are found for the metabolites:
247
Substance Test concentration Interference on ... Test matrix
cGlu cLac
(at 72 (at 14
mg/dL) mg/dL)
Acetamino- 2 mmol/L <|1.8| <|0.9| Blood

phen = para-
cetamol 0.3 g/L
Acetoacetate 2 mmol/L <|1.8| 1.0 Blood

(lithium
acetoacetate) 20 mg/dL
Acetylsalicylic 3.62 mmol/L <|1.8| <|0.9| Blood

acid
0.65 g/L
Ascorbic acid 170 µmol/L <|1.8| <|0.9| Blood
30 mg/L
Bilirubin 0.2 g/L <|1.8| <|0.9| Blood

(conj)
Bilirubin 0.2 g/L <|1.8| <|0.9| Blood

(unconj)
Chlorproma- 0.2 mmol/L <|1.8| <|0.9| Blood

zine HCl
0.06 g/L
Citrate 1 mmol/L <|1.8| <|0.9| Blood

(sodium
citrate 2H2O) 0.19 g/L
Citrate (triso- 2.5 mmol/L <|1.8| <|0.9| Blood

dium citrate
2H2O) 5 mmol/L <|1.8| <|0.9| Blood
7.5 mmol/L -1.8 <|0.9| Blood
10 mmol/L -2.0 -1.0 Blood
Creatinine 3 mmol/L <|1.8| <|0.9| Blood
0.34 g/L
2-deoxy 2.5 mmol/L 41 N/A Blood

Glucose
0.41 g/L
3.33 mmol/L 52 N/A Blood
0.55 g/L
5 mmol/L 82 N/A Blood
0.82 g/L
10 mmol/L 172 <|0.9| Blood
1.64 g/L
Dopamine HCl 1 mmol/L <|1.8| <|0.9| Blood
248
cGlu cLac
(at 72 (at 14
mg/dL) mg/dL)
Dopamine HCl 0.15 g/L <|1.8| <|0.9| Blood
D-Glucose 67 mmol/L N/A -1.9 Blood
1206 mg/dL
EDTA (edetate 3 mmol/L <|1.8| <|0.9| Blood

disodium
2H2O) 1 g/L
Ethanol 87 mmol/L <|1.8| <|0.9| Blood
400 mg/dL
Fluoride 50 mmol/L –2.2 -1.2 Blood

(sodium fluo-
ride) 0.95 g/L
Formaldehyde 10 mmol/L <|1.8| <|0.9| Blood
Formic acid 25 mmol/L <|1.8| <|0.9| Blood
Galactose 3.3 mmol/L 2.5 <|0.9| Blood
0.6 g/L
Glucosamine 2 mmol/L 2.2 <|0.9| Blood

HCl
0.36 g/L
Glycolic acid 0.25 mmol/L N/A 2.8 Blood
19 mg/L
0.33 mmol/L N/A 3.5 Blood
25 mg/L
0.5 mmol/L N/A 4.3 Blood
38 mg/L
1 mmol/L <|1.8| 4.7 Blood
76 mg/L
Hemolysis 2% 5.0 <|0.9| Blood
5% 3.1 1.4 Blood
10 % 3.8 <|0.9| Blood
20 % 4.3 <|0.9| Blood
Heparin 8000 iu/dL <|1.8| <|0.9| Blood
Ibuprofen 2.5 mmol/L <|1.8| <|0.9| Blood

(sodium)
0.52 g/L
Intralipid 2 % (400 mg/dL) <|1.8| <|0.9| Blood
249
cGlu cLac
(at 72 (at 14
mg/dL) mg/dL)
Intralipid 5 % (1000 mg/dL) <|1.8| <|0.9| Blood
Lactic acid 12 mmol/L <|1.8| N/A Blood
108 mg/dL
Maltose 5 mmol/L <|1.8| <|0.9| Blood

(monohy-
drate) 1.71 g/L
Mannose 1 mmol/L 2.0 <|0.9| Blood
0.18 g/L
Methanol 75 mmol/L <|1.8| <|0.9| Blood
Oxalate 1 mmol/L <|1.8| <|0.9| Blood

(sodium
oxalate) 0.09 g/L
Pralidoxime 0.045 mmol/L <|1.8| <|0.9| Blood

chloride
8 mg/L
Pyruvate 2 mmol/L <|1.8| <|0.9| Blood

(pyruvic acid
sodium salt) 0.18 g/L
Salicylic acid 4.34 mmol/L <|1.8| <|0.9| Blood
0.6 g/L
Sodium thio- 6 mmol/L 259 99 Blood

cyanate
350 mg/L
8 mmol/L 348 131 Blood
466 mg/L
700 mg/L
1400 mg/L
Urea 84 mmol/L <|1.8| <|0.9| Blood
5 g/L
Uric acid 1.5 mmol/L <|1.8| <|0.9| Blood
0.25 g/L
Xylose 1 mmol/L <|1.8| <|0.9| Blood
0.15 g/L
N/A: Interference has not been measured on the respective parameter
250
The following interference results are found for ctBil. Bilirubin can only be measured on
neonatal samples. This parameter is only available in the Neonate blood analysis 65 μL
mode
Limit for Interference on ctBil

clinical rele-
vance Test level(s) 5 mg/dL 15 mg/dL
0.5 mg/dL % Bias 1.5 mg/dL % Bias
Fluorescein 40 mg/L –15.4 –309 –16.6 –111
Patent Blue V 10 mg/L –4.7 –94 –6.5 –44

= Sulphan
blue*
Methylene –60 mg/L –22.5 –449 –18.0 –120

Blue*
Cardio Green 30 mg/L –4.1 –82 –5.4 –36

= Indocyanine
Green*
Evans Blue 5 mg/L <|0.5| <|10 %| <|1.5| <|10 %|
Intralipid 5 % (1000 <|0.5| <|10 %| <|1.5| <|10 %|

mg/dL)
SHb** 10 % 7.5 150 5.2 35
HbF 82 % <|0.5| <|10 %| <|1.5| <|10 %|
Hydroxocoba- 2 g/L –15.8 –317 –12.8 –85

lamin hydro-
chloride*
Cyanocoba- 2 g/L –9.0 –180 –10.9 –73

lamin*
Hemolysis 20 % (3000 <|0.5| <|10 %| <|1.5| <|10 %|

mg/dL)
Triglyceride ~500 mg/dL <|0.5| <|10 %| <|1.5| <|10 %|
* The result is marked with error message "OXI spectrum mismatch".
** The result is marked with error message "SHb too high" if SHb >10%". The result is
marked with message "Warning: SHb detected" if SHb >1 %.
pH was tested in the range from 6.8-7.9 and significant interference relative to physio-
logical pH was not observed.
Additional known interferences: As the spectra for HiCN and Beta-carotene overlap
with the spectrum of bilirubin, these are known interfering substances. Results from
samples that contain these substances should not be used.
Results outside the reportable range will not be displayed.
Oximetry parameters
These interference results were found for the oximetry parameters:
251
ctHb Interference on ctHb
Test levels 10 g/dL 20 g/dL
pH 6.8-8 <|0.5| <|0.5|
Fluorescein** 250 mg/L 0.7 0.6
Beta-carotene* 3.7 µmol/L <|0.5| <|0.5|
Patent Blue V 10 mg/L <|0.5| <|0.5|
Methylene Blue** 45 mg/L -0.8 -3.8
60 mg/L ND -4.9
Cardio Green 30 mg/L <|0.5| <|0.5|
Evans Blue 5 mg/L <|0.5| <|0.5|
Intralipid 5 % (1000 mg/dL) <|0.5| <|0.5|
HiCN*/** 30 % 1.3 2.4
SHb*** 10 % <|0.5| <|0.5|
Hydroxocobalamin 2 g/L 2.1 1.6

hydrochloride**
Cyanocobalamin** 2 g/L 0.6 <|0.5|
Bilirubin (conj) 342 µmol/L <|0.5| <|0.5|
Bilirubin (unconj) 342 µmol/L <|0.5| <|0.5|
Hemolysis 20 % <|0.5| <|0.5|
Triglyceride 587 mg/dL <|0.5| <|0.5|
* Interference calculated from the spectrum
** Analyzer message “OXI spectrum mismatch” is attached to the result
*** Analyzer message “SHb too high” is attached to the result
ND: Not determined
sO2 Interference on sO2
Test levels 0% 100 %
pH 6.8-8 <|1 %| <|1 %|
Fluorescein** 250 mg/L <|1 %| -3.0
Beta-carotene* 3.7 µmol/L <|1 %| <|1 %|
Patent Blue V 10 mg/L <|1 %| <|1 %|
Methylene Blue** 60 mg/L <|1 %| 3.9
Cardio Green 30 mg/L <|1 %| 1.0
252
sO2 Interference on sO2
Evans Blue 5 mg/L <|1 %| <|1 %|
Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|
HiCN*/** 30 % -3.1 -14.3
SHb*** 10 % 1.6 <|1 %|
HbF 50-80 % <|1 %| <|1 %|
Hydroxocobalamin hydrochloride** 2 g/L -3.7 -1.1
Cyanocobalamin** 2 g/L -2.0 -2.0
Bilirubin (conj) 342 µmol/L <|1 %| <|1 %|
Bilirubin (unconj) 342 µmol/L <|1 %| <|1 %|
Hemolysis 20 % <|1 %| <|1 %|
Triglyceride 587 mg/dL <|1 %| <|1 %|
COHb Interference on COHb
Test levels 0% 10 %
pH 6.8-8 <|1 %| <|1 %|
Fluorescein** 250 mg/L -4.1 -3.7
Methylene Blue** 60 mg/L -1.8 1.2
Cardio Green 30 mg/L <|1 %| <|1 %|
Evans Blue 5 mg/L <|1 %| <|1 %|
Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|
HiCN*/** 30 % 6.5 2.8
SHb*** 10 % <|1 %| <|1 %|
HbF 50-80 % <|1 %| ND
Hydroxocobalamin hydrochloride** 2 g/L 2.1 <|1 %|
Cyanocobalamin** 2 g/L 1.6 <|1 %|
253
COHb Interference on COHb
Test levels 0% 10 %
Hemolysis 20 % <|1 %| <|1 %|
ND: Not determined
MetHb Interference on MetHb
Test levels 0% 10 %
pH 6.8-8 <|1 %| -1.1 %/pH
Fluorescein** 250 mg/L 10.1 9.7
Patent Blue V 10 mg/L -1.0 <|1 %|
60 mg/L -24.0 ND
Cardio Green 30 mg/L -2.0 -1.2
Evans Blue 5 mg/L <|1 %| <|1 %|
Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|
HiCN*/** 30 % 23.9 20.6
SHb*** 10 % 1.0 -4.9
HbF 50-80 % <|1 %| ND
Hydroxocobalamin hydrochloride** 2 g/L 14.2 12.9
Cyanocobalamin** 2 g/L 5.7 4.7
Hemolysis 20 % <|1 %| <|1 %|
254
ND: Not determined
O2Hb Interference on O2Hb
pH 6.8-8 <|1 %| <|1 %|
Fluorescein** 250 mg/L <|1 %| -8.8
Patent Blue V 10 mg/L <|1 %| 2.0
Methylene Blue** 60 mg/L <|1 %| 32.0
Cardio Green 30 mg/L <|1 %| 2.7
Evans Blue 5 mg/L <|1 %| <|1 %|
Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|
HiCN*/** 30 % -2.1 -40.2
SHb*** 10 % 1.6 -2.1
HbF 50-80 % <|1 %| <|1 %|
Hydroxocobalamin hydrochloride** 2 g/L -2.8 -17.2
Cyanocobalamin** 2 g/L -1.8 -8.8
Hemolysis 20 % <|1 %| <|1 %|
HHb Interference on RHb
pH 6.8-8 <|1 %| <|1 %|
Fluorescein** 250 mg/L 2.8 –2.9
255
HHb Interference on RHb
Methylene Blue** 60 mg/L –4.4 ND
Cardio Green 30 mg/L <|1 %| <|1 %|
Evans Blue 5 mg/L <|1 %| <|1 %|
Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|
HiCN*/** 30 % 9.8 –28.3
SHb*** 10 % <|1 %| 1.2
HbF 50-80 % <|1 %| <|1 %|
Hydroxocobalamin hydrochloride** 2 g/L <|1 %| -19.8
Cyanocobalamin** 2 g/L 1.8 –5.0
Hemolysis 20 % <|1 %| <|1 %|
ND: Not determined
HbF Interference on HbF
Test levels 80 %
pH 6.8-8 40 %/pH
Fluorescein** 25 mg/L**** <|20 %|
Beta-carotene* 3.7 µmol/L <|20 %|
Patent Blue V 10 mg/L –37
Methylene Blue** 7.5 mg/L**** <|20 %|
Cardio Green 30 mg/L –30
Evans Blue 5 mg/L <|20 %|
Intralipid 5 % (1000 mg/dL) <|20 %|
HiCN* / ** 30 % HbF not reported
SHb*** 10 % HbF not reported
Hydroxocobalamin hydrochloride** 2 g/L <|20 %|
256
HbF Interference on HbF
Test levels 80 %
Cyanocobalamin** 2 g/L <|20 %|
Bilirubin (conj) 342 µmol/L <|20 %|
Bilirubin (unconj) 342 µmol/L <|20 %|
Hemolysis 20 % <|20 %|
Triglyceride 587 mg/dL <|20 %|
**** HbF is not reported for higher levels
ctBil sensitivity for MCHC variations
MCHC (Mean Corpuscular Hemoglobin Concentration) is used to estimate hematocrit,

Hct, which is used in the ctBil measurement (Bilirubin can only be measured on
neonatal samples. This parameter is only available in the Neonate blood analysis 65 μL
mode.). MCHC is an average Hb concentration in the red blood cell (RBC). If the RBC
volume decreases, MCHC increases. If an RBC has iron deficit, MCHC decreases.
Hct is determined from ctHb as follows:
Hct = ctHb/MCHC
A standard value of 332 g/L is used for MCHC which gives Hct = ctHb × 0.0301 if the
unit for ctHb is g/dL.
MCHC can, however, deviate from this standard value as shown in the table.
Metric values that use the erythrocytes Hct and MCHC to be determined are given for
apparently healthy white and black people of different ages [23].
Group of Age Hct mean Hct 95 % range MCHC mean, g/L MCHC 95 % range,
people g/L
Men Adults 0.47 0.39-0.55 340 310-370
Women Adults 0.42 0.36-0.48 330 300-360
257
Group of Age Hct mean Hct 95 % range MCHC mean, g/L MCHC 95 % range,
people g/L
Boys Newborn 0.59 0.53-0.65 330 320-340
1 month 0.50 0.44-0.56 320 310-330
3 months 0.45 0.39-0.52 330 320-340
6 months 0.46 0.39-0.51 300 290-310
9 months 0.45 0.39-0.52 280 270-300
1 year 0.41 0.37-0.45 290 280-300
2 years 0.40 0.36-0.47 300 280-310
4 years 0.37 0.30-0.44 280 270-290
8 years 0.41 0.37-0.45 290 280-300
14 years 0.41 0.36-0.46 300 290-310
Girls Newborn 0.58 0.51-0.65 340 330-350
1 month 0.49 0.42-0.56 320 310-330
3 months 0.44 0.39-0.51 330 320-340
6 months 0.44 0.39-0.50 320 310-330
9 months 0.43 0.37-0.50 300 290-310
1 year 0.43 0.37-0.49 300 290-310
2 years 0.43 0.36-0.50 300 290-310
4 years 0.43 0.36-0.51 280 270-290
8 years 0.40 0.36-0.46 280 270-290
14 years 0.40 0.36-0.47 290 280-300
If ΔMCHC is defined as ΔMCHC = 332 g/L - MCHC, then the contribution to the relative
error on the ctBil* measurement is as follows:
ΔctBil* / ctBil* = –(Hct / 1–Hct) × (ΔMCHC / MCHC)
A worst-case example, where 95 % confidence values are used:
A newborn girl with Hct = 0.58, MCHC = 350 g/L and ctBil* = 400 µmol/L. ctHb may
be derived as Hct × MCHC = 0.58 × 350 g/L = 20.3 g/dL (reference range is 18.0-21.0
g/dL).
ΔctBil* / ctBil* = -(0.58/1 - 0.58) × (-18/350) = +0.071 and ΔctBil* = 0.071 × 400 =
28 µmol/L.
If the reference value for Hct is known, it is possible to correct the shown ctBil* value
with this equation:
ctBil*corrected = ctBil*displayed ×(1-ctHbdisplayed × 0.0301/1-Hctreference)
ctHb is measured in g/dL.
ctBil* is sensitive to pH deviations from the nominal value of pH = 7.4.
258
Alternative presentation of interference results
pH/blood gas (alternative presentation)
Substance Max. Conc. Highest interferent level free from interference Test matrix
tested
pH pCO2 pO2
Interference limit
10 mpH 0.5 mmHg / 1 mmHg /

0.067 kPa 0.13 kPa
Intralipid 5% (1000 * * * Blood /

mg/dL) aqueous
Fluorescein 400 mg/L * * * Blood
K+ 17 mmol/L / * - - Blood
mEq/L
Na+ 190 mmol/L / * - - Blood

mEq/L
Ca2+ 5.5 mmol/L * - - Blood
11 mEq/L
22 mg/dL
Hemolysis 20 % * * 13.3 % Blood
Unconj. Bilir- 500 µmol/L * * * Blood

ubin
29.2 mg/dL
Conj. Bilirubin 400 µmol/L * * * Blood
23.4 mg/dL
* = No interference within the tested concentration range.
- = Not tested.
Electrolytes (alternative presentation)
Substance Test Highest interferent level free from interference Test matrix
concentra-
tion cK+ cNa+ cCa2+ cCl—
Interference limit
0.1 1 mmol/L / 0.2 1 mmol/L /

mmol/L / 1 mEq/L mmol/L / 1 mEq/L
0.1 mEq/L 0.04
mEq/L /
0.08 mg/dL
Lithium 3.2 * * * - Plasma

mmol/L /
(Li+) mEq/L
259
Potassium 12 - * * - Plasma
mmol/L /
(K+) mEq/L
Calcium 3.4 mmol/L * 2.8 mmol/L - - Plasma
(Ca2+) 6.8 mEq/L 5.6 mEq/L
13.6 mg/dL 11.2 mg/dL
Sodium 180 - - 124 - Plasma

mmol/L / mmol/L /
(Na+) mEq/L mEq/L
Ammonium 1 mmol/L * * - 0.9 mmol/L Plasma
(NH4+) 1.7 mg/dL 1.5 mg/dL
Magnesium 15 mmol/L - * 13.0 - Aqueous

mmol/L
(Mg2+)
30 mEq/L 26.0 mEq/L
Zinc 170 µmol/L * * 142 µmol/L - Plasma
(Zn2+) 1111 µg/dL 928 µg/dL
Strontium 150 µmol/L - - * - Plasma
(Sr2+) 300 µEq/L
pH 6.8-8 - - 0.54 * Aqueous/
pH-units plasma
Bromide 37.5 - - - 0.5 Plasma

mmol/L / mmol/L /
(Br-) mEq/L mEq/L
Iodode 2.99 - - - 0.3 Plasma

mmol/L / mmol/L /
(I-) mEq/L mEq/L
Fluoride 1 mmol/L / - - - * Plasma

mEq/L
(F-)
Perchlorate 1.5 - - * 0.2 Plasma

mmol/L / mmol/L /
(ClO4-) mEq/L mEq/L
Benzalko- 30 µg/mL 2.4 µg/mL 0.75 µg/mL 1 µg/mL * Plasma

nium
chloride
Acetylsali- 3.62 - - - 1.7 mmol/L Plasma

cylic acid mmol/L
0.65 g/L 0.31 g/L
Salicylic 4.34 - - - 1.5 mmol/L Plasma

acid mmol/L
0.6 g/L 0.2 g/L
Thiocyanic 1.72 - - - 0.1 mmol/L Plasma

acid mmol/L
260
Thiocyanic 0.1 g/L - - - 6 mg/L Plasma

acid
Ascorbic 850 µmol/L - - - * Plasma

acid
0.15 g/L
Citrate 40 mmol/L - - - 8 mmol/L Plasma
7.7 g/L 1.5 g/L
Oxalate 10 mmol/L - - - * Plasma
0.9 g/L
Lactate 25 mmol/L - - - * Plasma
225 mg/dL
Caprylic 0.12 - - - * Plasma

acid mmol/L
0.017 g/L
Acetyl-tryp- 0.12 - - - * Plasma

tophane mmol/L
0.03 g/L
Hemolysis 20% 0.15 % 0.85 % 0.47 % 1.27 % Blood
Intralipid 5% * 2% * 3% Plasma
Unconj. 500 µmol/L * * * 500 µmol/L Blood

Bilirubin
29.2 mg/dL 29.2 mg/dL
Conj. Bilir- 400 µmol/L * 305 µmol/L * * Blood

ubin
23.4 mg/dL 17.9 mg/dL
- = Not tested.
Metabolites (alternative presentation)
Substance Max. Conc. tested Highest interferent level free from Test matrix
interference
Glu Lac
Interference limit
0.1 mmol/L / 0.1 mmol/L /
1.8 mg/dL 0.9 mg/dL
Acetominophen = 2 mmol/L * * Blood

paracetamol
0.3 g/L
Acetylsalicylic 3.62 mmol/L * * Blood

acid
0.65 g/L
261
Ibuprofen 2.5 mmol/L * * Blood

(sodium)
0.52 g/L
Dopamine HCl 1 mmol/L * * Blood
0.15 g/L
Chlorpromazine 0.2 mmol/L * * Blood

HCl
0.06 g/L
Ethanol 87 mmol/L * * Blood
400 mg/dL
Glucosamine HCl 2 mmol/L 1.67 mmol/L * Blood
0.36 g/L 0.3 g/L
Glycolic acid 1 mmol/L * 0.08 mmol/L Blood
76 mg/L 6 mg/L
Lactic acid 12 mmol/L * Blood
108 mg/dL
Maltose (mono- 5 mmol/L * * Blood

hydrate)
1.71 g/L
Mannose 1 mmol/L 0.9 mmol/L * Blood
0.18 g/L 0.16 g/L
Salicylic acid 4.34 mmol/L * * Blood
0.6 g/L
Sodium thiocya- 24 mmol/L 0.065 mmol/L 0.07 mmol/L Blood

nate
1400 mg/L 3.8 mg/L 4.1 g/L
Xylose 1 mmol/L * * Blood
0.15 g/L
Acetoacetate 2 mmol/L * 1.8 mmol/L Blood

(Lithium acetace-
toacetate) 20 mg/dL 18 mg/dL
Creatinine 3 mmol/L * * Blood
0.34 g/L
Galactose 3.3 mmol/L 2.3 mmol/L * Blood
0.6 g/L 0.4 g/L
D-Glucose 67 mmol/L 32 mmol/L Blood
1206 mg/dL 576 mg/dL
Pyruvate (pyruvic 2 mmol/L * * Blood

acid sodium salt)
0.18 g/L
262
Urea 84 mmol/L * * Blood
5 g/L
Uric acid 1.5 mmol/L * * Blood
0.25 g/L
Heparin 8000 iu/dL * * Blood
EDTA (Edetate 3 mmol/L * * Blood

disodium 2H2O)
1 g/L
Citrate (sodium 1 mmol/L * * Blood

citrate 2H2O)
0.19 g/L
Oxalate (sodium 1 mmol/L * * Blood

oxalate)
0.09 g/L
Fluoride (Sodium 50 mmol/L 41 mmol/L 38 mM Blood

fluoride)
0.95 g/L 0.8 g/L 0.72 g/L
Pralidoxime 0.045 mmol/L * * Blood

chloride
8 mg/L
2-deoxy Glucose 10 mmol/L 0.1 mmol/L - Blood
1.64 g/L 16 mg/L
Unconjugated 0.2 g/L * * Blood

Bilirubin
Conjugated Bilir- 0.2 g/L * * Blood

ubin
Ascorbic acid 170 µmol/L * * Blood
30 mg/L
Intralipid 5 % (1000 * * Blood

mg /dL)
Hemolysis 20 % 8.3% * Blood
Methanol 75 mmol/L * * Blood
Formaldehyde 10 mmol/L * * Blood
Formic Acid 25 mmol/L * * Blood
- = Not tested.
ctBil (Bilirubin can only be measured on neonatal samples. This parameter is only
available in the Neonate blood analysis 65 µL mode.
263
Interference dose response test results
Potential Interferent Concentration of interfering substances above which

significant interference (≥±10 %) occurs
85 µmol/L ctBil** or 5 260 µmol/L ctBil** or 15

mg/dL ctBil** mg/dL ctBil**
Fluorescein 1.5 mg/L 4 mg/L
Patent Blue V = Sulphan blue 1.5 mg/L 2.5 mg/L
Methylene Blue 0.75 mg/L 2 mg/L
Cardio Green = Indocyanine 3 mg/L 10 mg/L

Green
Evans Blue * *
Intralipid * *
SHb 1.1 % 1.6 %
HbF * *
Hydroxocobalamin hydro- 0.19 g/L 0.5 g/L

chloride
Cyanocobalamin 0.2 g/L 0.7 g/L
Hemolysis * *
Triglyceride * *
* No interference within the tested concentration range.
** ctBil (Bilirubin can only be measured on neonatal samples. This parameter is only
available in the Neonate blood analysis 65 µL mode.
pH was tested in the range from 6.8-7.9 and significant interference relative to physio-
logical pH was not observed.
Additional known interferences: As the spectra for HiCN and Beta-carotene overlap
with the spectrum of bilirubin, these are known interfering substances. Results from
samples that contain these substances should not be used.
Oximetry parameters (alternative presentation)
ctHb Highest interferent level free from inter-

ference
Interference limit 0.5 g/dL 0.5 g/dL
pH 6.8-8 * *
Fluorescein 250 mg/L 172 mg/L 140 mg/L
Beta-carotene 3.7 µmol/L * *
Patent Blue V 10 mg/L * *
Methylene Blue 45 mg/L 29.1 mg/L 6.0 mg/L
264
ctHb Highest interferent level free from inter-

ference
Interference limit 0.5 g/dL 0.5 g/dL
Methylene Blue 60 mg/L ND 6.0 mg/L
Cardio Green 30 mg/L * *
Evans Blue 5 mg/L * *
Intralipid 5 % (1000 mg/dL) * *
HiCN 30 % 11.4 % 6.2 %
SHb 10 % * *
Hydroxocobalamin 2 g/L 0.8 g/L 0.6 g/L

hydrochloride
Cyanocobalamin 2 g/L 1.8 g/L *
Bilirubin (conj) 342 µmol/L * *
Bilirubin (unconj) 342 µmol/L * *
Hemolysis 20 % * *
Triglyceride 587 mg/dL * *
* = No interference within the tested concentration range
sO2 Highest interferent level free from inter-

ference
Interference limit 1% 1%
pH 6.8-8 * *
Fluorescein 250 mg/L * 83 mg/L
Methylene Blue 60 mg/L * 17 mg/L
Cardio Green 30 mg/L * 30 mg/L
HiCN 30 % 10 % 2%
SHb 10 % 6% *
HbF 50-80 % * *
Hydroxocobalamin hydro- 2 g/L 0.6 g/L 1.9 g/L

chloride
Cyanocobalamin 2 g/L 1.0 g/L 1.4 g/L
265
sO2 Highest interferent level free from inter-

ference
Bilirubin (conj) 342 µmol/L * '
Hemolysis 20 % * *
COHb Highest interferent level free from

interference
Test levels 0% 10 %
pH 6.8-8 * *
Methylene Blue 60 mg/L 45 mg/L 48 mg/L
HiCN 30 % 4.5 % 10.4 %
SHb 10 % * *
HbF 50-80 % * ND
Hydroxocobalamin hydro- 2 g/L 1 g/L *

chloride
Cyanocobalamin 2 g/L 1.3 g/L *
Hemolysis 20 % * *
ND: Not determined
266
MetHb Highest interferent level free from inter-

ference
Test levels 0% 10 %
pH 6.8-8 * 0.9 pH-unit
Patent Blue V 10 mg/L 11 mg/L *
Methylene Blue 30 mg/L 2.5 mg/L 1.6 mg/L
60 mg/L 2.5 mg/L ND
Cardio Green 30 mg/L 16 mg/L 28 mg/L
HiCN 30 % 1.3 % 1.5 %
SHb 10 % 10 % 1.2 %
HbF 50-80 % * ND

chloride
Hemolysis 20 % * *
ND: Not determined
O2Hb Highest interferent level free from inter-

ference
pH 6.8-8 * *
Fluorescein 250 mg/L * 26 mg/L
Patent Blue V 10 mg/L * 5 mg/L
Methylene Blue 60 mg/L * 2 mg/L
Cardio Green 30 mg/L * 10 mg/L
267
O2Hb Highest interferent level free from inter-

ference
HiCN 30 % 14 % 0.7 %
SHb 10 % 6% 5%
HbF 50-80 % * *

chloride
Hemolysis 20 % * *
HHb Highest interferent level free from inter-

ference
pH 6.8-8 * *
Methylene Blue 45 mg/L 14 mg/L 16 mg/L
60 mg/L 14 mg/L ND
HiCN 30 % 3% 1%
SHb 10 % * 8%
HbF 82 % * *
Hydroxocobalamin hydro- 2 g/L * 0.1 g/L

chloride
268
HHb Highest interferent level free from inter-

ference
Hemolysis 20 % * *
ND: Not determined
HbF Highest interferent level free from

interference
Test levels 80 %
Interference limit 20 %
pH 6.8-8 0.5 pH-unit
Fluorescein 25 mg/L *
Beta-carotene 3.7 µmol/L *
Patent Blue V 10 mg/L 5 mg/L
Methylene Blue 7.5 mg/L *
Cardio Green 30 mg/L 20 mg/L
Evans Blue 5 mg/L *
Intralipid 5 % (1000 mg/dL) *
HiCN 30 % HbF not reported
SHb 10 % HbF not reported
Hydroxocobalamin hydrochloride 2 g/L *
Cyanocobalamin 2 g/L *
Bilirubin (conj) 342 µmol/L *
Bilirubin (unconj) 342 µmol/L *
Hemolysis 20 % *
Triglyceride 587 mg/dL *
External test results
Study design - precision/reproducibility
A point-of-care (POC) precision study was done with the use of NCCLS “Evaluation of
Precision Performance of Quantitative Measurement Methods; Approved Guideline –
Second Edition”, NCCLS EP5-A2, 2004 as guidance [1].
269
The study was done at three different POC sites. The sites were not the same for all
the parameters and the measurements were not performed at the same time. Some of
the results derive from measurements started at different times and at different sites.
Each site used one ABL90 FLEX analyzer for precision evaluation of syringe mode, one
ABL90 FLEX analyzer for precision evaluation of capillary mode and one ABL735
analyzer for reference purposes.
The test material was prepared samples of heparinized whole blood, except for ctBil*
where aqueous solutions were used. Samples for all parameters, preparations simu-
lating high, medium and low physiological levels.
In each study multiple POC staff members performed sample handling and transfer.
Each study was done over 20 test days. On each test day, tests were done on each
parameter and level in duplicate per run, two runs per day. The testing was done in
both syringe and capillary modes. Sr is an estimate of repeatability and ST is an esti-
mate of precision as defined in NCCLS EP5-A2 [1].
ABL90 FLEX precision - syringe study - site 1
Low level pH pCO2 pO2 Ca Cl K
Unit mmHg mmHg mg/dL mEq/L mEq/L
Mean 7.267 28.1 44.8 2.28 93 -
Sr 0.0016 0.42 0.20 0.01 0.25 -
ST 0.0031 0.59 0.84 0.07 0.94 -
% CV - 2.1 1.9 3.1 1.0 -
n 80 80 80 80 80 -
Low level Na Glu Lac tHb sO2 COHb
Unit mEq/L mg/dL mg/dL g/dL % %
Mean 119 11.8 - 3.8 76.2 -
Sr 0.2 0.49 - 0.06 0.32 -
ST 0.6 0.93 - 0.07 0.45 -
% CV 0.5 7.9 - 1.9 0.6 -
n 80 80 - 80 80 -
Low level MetHb HHb O2Hb HbF ctBil*
Unit % % % % mg/dL
Mean - - 74.1 - 2.1
Sr - - 0.30 - 0.057
ST - - 0.34 - 0.099
% CV - - 0.5 - 4.8
n - - 80 - 80
270
Medium pH pCO2 pO2 Ca Cl K

level
Mean 7.363 42.0 78.0 4.83 108 4.87
Sr 0.0016 0.52 0.37 0.02 0.25 0.049
ST 0.0036 0.80 1.19 0.07 1.22 0.083
% CV - 1.9 1.5 1.5 1.1 1.7
n 80 80 80 80 80 80
Medium Na Glu Lac tHb sO2 COHb

level
Mean 141 95.4 19.2 14.8 92.9 3.4
Sr 0.4 0.70 0.45 0.09 0.17 0.04
ST 0.7 2.77 1.07 0.14 0.39 0.18
% CV 0.5 2.9 5.6 0.9 0.4 5.2
n 80 80 80 80 80 80
Medium MetHb HHb O2Hb HbF ctBil*

level
Unit % % % % mg/dL
Mean 3.1 6.9 90.6 46.6 7.3
Sr 0.08 0.17 0.21 1.70 0.063
ST 0.15 0.29 0.27 5.02 0.110
% CV 4.8 4.2 0.3 10.8 1.5
n 80 80 80 80 80
High level pH pCO2 pO2 Ca Cl K
Mean 7.471 61.0 206.3 7.62 122 6.58
Sr 0.0010 0.88 2.21 0.04 0.22 0.022
ST 0.0029 1.81 3.55 0.11 0.81 0.053
% CV - 3.0 1.7 1.5 0.7 0.8
n 80 80 80 80 80 80
High level Na Glu Lac tHb sO2 COHb
Mean 151 252.5 146.3 21.4 99.9 42.1
Sr 0.3 2.16 4.04 0.08 0.09 0.09
271
ST 0.8 8.03 8.56 0.15 0.22 0.21
% CV 0.5 3.2 5.9 0.7 0.2 0.5
n 80 80 80 80 80 80
High level MetHb HHb O2Hb HbF ctBil*
Unit % % % % mg/dL
Mean 9.6 23.5 97.5 69.6 30.4
Sr 0.07 0.23 0.16 5.70 0.204
ST 0.21 0.39 0.19 8.25 0.274
% CV 2.2 1.7 0.2 11.9 0.9
n 80 80 80 80 80
Mean 7.277 28.2 45.0 2.39 94 -
Sr 0.0022 0.59 0.17 0.02 0.11 -
ST 0.0036 0.75 0.60 0.09 1.12 -
% CV - 2.7 1.3 3.8 1.2 -
n 80 80 80 80 80 -
Mean 119 13.8 - 3.8 75.5 -
Sr 0.3 0.57 - 0.05 0.17 -
ST 0.7 1.50 - 0.07 0.27 -
% CV 0.6 10.8 - 1.8 0.4 -
n 80 80 - 80 80 -
Unit % % % % mg/dL
Mean - - 71.1 - 2.1
Sr - - 0.22 - 0.050
ST - - 0.37 - 0.084
272
% CV - - 0.5 - 4.1
n - - 80 - 80

level
Mean 7.372 42.0 73.6 4.87 108 4.68
Sr 0.0010 0.63 0.92 0.02 0.25 0.025
ST 0.0029 0.83 1.17 0.09 1.23 0.059
% CV - 2.0 1.6 1.9 1.1 1.3
n 80 80 80 80 80 80

level
Mean 141 96.9 19.0 15.1 93.0 3.3
Sr 0.4 0.57 0.45 0.10 0.09 0.07
ST 0.7 3.69 1.20 0.11 0.29 0.22
% CV 0.5 3.8 6.3 0.7 0.3 6.7
n 80 80 80 80 80 80

level
Unit % % % % mg/dL
Mean 3.7 6.8 89.9 39.1 7.3
Sr 0.07 0.09 0.16 2.12 0.049
ST 0.17 0.30 0.24 5.57 0.094
% CV 4.6 4.4 0.3 14.3 1.3
n 80 80 80 80 80
Mean 7.470 59.8 201.6 7.52 123 6.69
Sr 0.0012 0.94 0.96 0.04 0.19 0.025
ST 0.0033 1.25 2.05 0.17 1.24 0.063
% CV - 2.1 1.0 2.3 1.0 0.9
n 80 80 80 80 80 80
273
Mean 150 263.1 139.1 21.9 99.8 32.2
Sr 0.3 3.39 3.39 0.13 0.09 0.05
ST 0.7 11.66 11.98 0.16 0.13 0.29
% CV 0.5 4.4 8.6 0.7 0.1 0.9
n 80 80 80 80 80 80
Unit % % % % mg/dL
Mean 10.0 23.7 96.5 60.2 30.3
Sr 0.06 0.17 0.12 2.78 0.086
ST 0.23 0.29 0.20 6.39 0.497
% CV 2.3 1.2 0.2 10.6 1.6
n 80 80 80 80 80
Mean 7.273 27.7 43.9 2.23 94 -
Sr 0.0020 0.62 0.26 0.01 0.25 -
ST 0.0044 0.65 0.56 0.05 1.17 -
% CV - 2.4 1.3 2.0 1.2 -
n 80 80 80 80 80 -
Mean 120 14.1 - 3.8 73.5 -
Sr 0.3 0.49 - 0.07 0.21 -
ST 0.6 0.97 - 0.11 0.41 -
% CV 0.5 6.8 - 2.9 0.6 -
n 80 80 - 80 80 -
Unit % % % % mg/dL
274
Mean - - 71.9 - 2.2
Sr - - 0.16 - 0.065
ST - - 0.62 - 0.107
% CV - - 0.9 - 4.9
n - - 80 - 80

level
Mean 7.375 40.8 76.7 4.83 109 4.69
Sr 0.0011 0.74 0.70 0.04 0.50 0.022
ST 0.0035 0.94 0.98 0.09 1.74 0.049
% CV - 2.3 1.3 1.8 1.6 1.0
n 80 80 80 80 80 80

level
Mean 141 102.6 19.2 15.1 93.4 3.0
Sr 0.4 0.85 0.61 0.07 0.15 0.00
ST 0.8 3.00 1.33 0.14 0.34 0.24
% CV 0.6 2.9 6.9 0.9 0.4 8.0
n 80 80 80 80 80 80

level
Unit % % % % mg/dL
Mean 3.4 6.4 90.9 36.6 7.6
Sr 0.07 0.14 0.39 1.95 0.072
ST 0.19 0.33 0.50 4.25 0.125
% CV 5.5 5.2 0.5 11.6 1.6
n 80 80 76 76 80
Mean 7.475 60.1 205.0 7.57 122 6.62
Sr 0.0012 1.05 0.54 0.03 0.19 0.019
ST 0.0068 1.14 2.12 0.11 0.99 0.059
275
% CV - 1.9 1.0 1.4 0.8 0.9
n 80 80 80 80 80 80
Mean 151 277.2 147.5 21.9 99.6 39.7
Sr 0.3 1.88 3.34 0.11 0.10 0.00
ST 0.7 5.51 17.34 0.13 0.13 0.22
% CV 0.5 2.0 11.8 0.6 0.1 0.5
n 80 80 80 80 80 80
Unit % % % % mg/dL
Mean 10.6 25.8 97.7 61.7 31.6
Sr 0.06 0.22 0.17 1.79 0.277
ST 0.24 0.25 0.21 5.60 0.409
% CV 2.2 1.0 0.2 9.1 1.3
n 80 80 80 80 80
ABL90 FLEX precision - syringe study - pooled data
Pooled data from site 1, 3 and 5.
Mean 7.272 28.0 44.5 2.30 94 -
Sr 0.0019 0.55 0.21 0.01 0.21 -
ST 0.0037 0.67 0.68 0.07 1.08 -
% CV - 2.4 1.5 3.1 1.2 -
n 240 240 240 240 240 -
Mean 119 13.2 - 3.8 75.1 -
Sr 0.3 0.52 - 0.06 0.24 -
ST 0.6 1.16 - 0.09 0.38 -
276
% CV 0.5 8.8 - 2.2 0.5 -
n 240 240 - 240 240 -
Unit % % % % mg/dL
Mean - - 72.4 - 2.1
Sr - - 0.23 - 0.058
ST - - 0.46 - 0.097
% CV - - 0.6 - 4.6
n - - 240 - 240

level
Mean 7.370 41.6 76.1 4.84 108 4.75
Sr 0.0012 0.64 0.70 0.03 0.35 0.034
ST 0.0034 0.86 1.12 0.08 1.42 0.065
% CV - 2.1 1.5 1.7 1.3 1.4
n 240 240 240 240 240 240

level
Mean 141 98.3 19.1 15.0 93.1 3.2
Sr 0.4 0.72 0.51 0.09 0.14 0.05
ST 0.7 3.18 1.20 0.13 0.34 0.21
% CV 0.5 3.2 6.3 0.9 0.4 6.6
n 240 240 240 240 240 240

level
Unit % % % % mg/dL
Mean 3.4 6.7 90.5 40.7 7.4
Sr 0.07 0.14 0.27 1.93 0.062
ST 0.17 0.31 0.35 4.98 0.110
% CV 5.0 4.6 0.4 12.2 1.5
n 240 240 236 236 240
277
Mean 7.472 60.3 204.3 7.57 122 6.63
Sr 0.0011 0.96 1.43 0.03 0.20 0.022
ST 0.0047 1.43 2.66 0.13 1.03 0.059
% CV - 2.4 1.3 1.8 0.8 0.9
n 240 240 240 240 240 240
Mean 151 264.3 144.3 21.7 99.7 38.0
Sr 0.3 2.56 3.60 0.11 0.09 0.06
ST 0.7 8.77 13.13 0.15 0.17 0.24
% CV 0.5 3.3 9.1 0.7 0.2 0.6
n 240 240 240 240 240 240
Unit % % % % mg/dL
Mean 10.1 24.3 97.2 63.8 30.7
Sr 0.06 0.21 0.15 3.80 0.205
ST 0.23 0.32 0.20 6.84 0.404
% CV 2.3 1.3 0.2 10.7 1.3
n 240 240 240 240 240
ABL90 FLEX Precision - capillary study - site 1
Mean 7.265 28.0 45.3 2.27 93 -
Sr 0.0021 0.44 0.35 0.10 0.30 -
ST 0.0044 0.65 0.89 0.13 0.91 -
% CV - 2.3 2.0 5.6 1.0 -
n 80 80 80 80 80 -
278
Mean 121 14 - 3.7 77.3 -
Sr 0.4 0.53 - 0.04 0.24 -
ST 0.7 1.54 - 0.07 0.59 -
% CV 0.6 10.9 - 2.0 0.8 -
n 80 80 - 80 80 -
Unit % % % % mg/dL
Mean - - 75.4 - 2.1
Sr - - 0.31 - 0.047
ST - - 0.44 - 0.087
% CV - - 0.6 - 4.2
n - - 80 - 80

level
Mean 7.372 42.2 77.6 4.83 108 4.86
Sr 0.0018 0.49 0.99 0.03 0.42 0.043
ST 0.0064 0.81 1.46 0.07 1.45 0.114
% CV - 1.9 1.9 1.5 1.3 2.4
n 80 80 80 80 80 80

level
Mean 141 96 19 14.9 93.2 3.4
Sr 0.4 1.60 0.62 0.10 0.18 0.00
ST 0.9 3.33 1.05 0.23 0.36 0.19
% CV 0.7 3.4 5.5 1.5 0.4 5.7
n 80 80 80 80 80 80

level
Unit % % % % mg/dL
Mean 3.0 6.6 90.8 46.0 7.3
Sr 0.08 0.24 0.20 2.59 0.087
ST 0.18 0.44 0.31 5.74 0.109
279

level
% CV 6.0 6.7 0.3 12.5 1.5
n 80 80 80 80 80
Mean 7.470 61.5 206.3 7.61 121 6.57
Sr 0.0027 0.75 2.38 0.12 0.39 0.034
ST 0.0044 1.13 4.72 0.20 1.01 0.070
% CV - 1.8 2.3 2.6 0.8 1.1
n 80 80 80 80 80 80
Mean 151 277 144 21.3 99.9 38.1
Sr 0.4 3.09 2.67 0.14 0.10 0.00
ST 1.0 11.0 9.3 0.21 0.20 0.16
% CV 0.7 4.0 6.5 1.0 0.2 0.4
n 80 80 80 80 80 80
Unit % % % % mg/dL
Mean 9.6 23.2 97.5 68.9 30.3
Sr 0.13 0.24 0.20 2.48 0.367
ST 0.22 0.41 0.24 5.90 0.343
% CV 2.3 1.8 0.2 8.6 1.1
n 80 80 80 80 80
ABL90 FLEX precision - capillary study - site 3
Mean 7.280 28.2 45.3 2.40 94 -
Sr 0.0025 0.64 0.58 0.05 0.39 -
ST 0.0034 0.69 1.00 0.11 1.24 -
280
% CV - 2.4 2.2 4.5 1.3 -
n 80 80 80 80 80 -
Mean 119 14 - 3.8 75.5 -
Sr 0.3 0.60 - 0.08 0.25 -
ST 0.7 1.58 - 0.08 0.38 -
% CV 0.6 11.4 - 2.1 0.5 -
n 80 80 - 80 80 -
Unit % % % % mg/dL
Mean - - 72.6 - 2.1
Sr - - 0.25 - 0.037
ST - - 0.40 - 0.076
% CV - - 0.6 - 3.7
n - - 80 - 80

level
Mean 7.375 41.7 75.4 4.88 108 4.68
Sr 0.0020 0.73 0.78 0.03 0.37 0.035
ST 0.0036 0.83 1.32 0.10 1.51 0.070
% CV - 2.0 1.8 2.1 1.4 1.5
n 80 80 80 80 80 80

level
Mean 141 99 19 15.2 93.5 3.3
Sr 0.4 1.05 0.67 0.15 0.16 0.04
ST 1.1 2.77 1.18 0.15 0.35 0.21
% CV 0.8 2.8 6.1 1.0 0.4 6.4
n 80 80 80 80 80 80
281

level
Unit % % % % mg/dL
Mean 3.7 6.5 85.7 42.1 7.3
Sr 0.09 0.24 0.29 2.06 0.059
ST 0.36 0.39 0.37 6.16 0.095
% CV 9.8 6.1 0.4 14.6 1.3
n 80 80 80 80 80
Mean 7.471 59.9 201.6 7.53 124 6.74
Sr 0.0020 1.11 1.23 0.13 0.22 0.039
ST 0.0024 1.38 2.53 0.27 1.78 0.073
% CV - 2.3 1.3 3.6 1.4 1.1
n 80 80 80 80 80 80
Mean 151 263 139 21.9 99.8 32.2
Sr 0.3 3.73 3.54 0.19 0.08 0.06
ST 0.9 10.7 11.9 0.22 0.11 0.30
% CV 0.6 4.1 8.5 1.0 0.1 0.9
n 80 80 80 80 80 80
Unit % % % % mg/dL
Mean 9.9 24.1 96.5 60.6 30.2
Sr 0.10 0.24 0.18 1.94 0.186
ST 0.23 0.38 0.24 5.67 0.492
% CV 2.3 1.6 0.3 9.4 1.6
n 80 80 80 80 80
282
ABL90 FLEX precision - capillary study - site 5
Mean 7.267 27.6 43.8 2.22 94 -
Sr 0.0028 0.68 0.36 0.06 0.25 -
ST 0.0051 0.65 0.83 0.07 1.12 -
% CV - 2.4 1.9 3.2 1.2 -
n 80 80 80 80 80 -
Mean 120 14 - 3.7 75.0 -
Sr 0.2 0.53 - 0.04 0.26 -
ST 0.6 1.48 - 0.06 0.46 -
% CV 0.5 10.4 - 1.6 0.6 -
n 80 80 - 80 80 -
Unit % % % % mg/dL
Mean - - 74.4 - 2.2
Sr - - 0.19 - 0.050
ST - - 0.66 - 0.080
% CV - - 0.9 - 3.6
n - - 80 - 80

level
Mean 7.377 40.8 76.9 4.83 109 4.72
Sr 0.0027 0.65 0.48 0.04 0.27 0.039
ST 0.0042 0.98 1.58 0.09 1.32 0.082
% CV - 2.4 2.1 1.8 1.2 1.7
n 80 80 80 80 80 80

level
Mean 141 101 19 15.0 93.4 3.1
283

level
Sr 0.5 0.99 0.56 0.11 0.16 0.00
ST 0.8 3.07 1.24 0.33 0.35 0.24
% CV 0.5 3.0 6.5 2.2 0.4 7.9
n 80 80 80 80 80 80

level
Unit % % % % mg/dL
Mean 3.4 6.7 90.9 37.0 7.5
Sr 0.10 0.16 0.18 2.45 0.104
ST 0.16 0.33 0.35 4.54 0.131
% CV 4.5 5.0 0.4 12.3 1.7
n 80 80 80 80 80
Mean 7.477 60.1 207.6 7.57 122 6.62
Sr 0.0034 0.71 1.97 0.10 0.30 0.034
ST 0.0074 0.99 3.37 0.20 1.01 0.068
% CV - 1.6 1.6 2.6 0.8 1.0
n 80 80 80 80 80 80
Mean 151 276 147 21.7 99.7 41.7
Sr 0.4 2.95 3.04 0.14 0.09 0.00
ST 0.7 9.5 10.4 0.20 0.16 0.25
% CV 0.5 3.4 7.1 0.9 0.2 0.6
n 80 80 80 80 80 80
Unit % % % % mg/dL
Mean 10.5 24.1 97.5 62.4 31.3
Sr 0.06 0.19 0.11 2.74 0.384
ST 0.21 0.60 0.21 4.98 0.404
% CV 2.0 2.5 0.2 8.0 1.3
284
n 80 80 80 80 80
in the Neonate blood analysis 65 μL mode
ABL90 FLEX precision - capillary study - pooled data
Pooled data for site 1, 3 and 5.
Mean 7.271 27.9 44.8 2.30 94 -
Sr 0.0025 0.59 0.44 0.07 0.32 -
ST 0.0044 0.67 0.91 0.10 1.10 -
% CV - 2.4 2.0 4.6 1.2 -
n 240 240 240 240 240 -
Mean 120 14 - 3.7 75.9 -
Sr 0.3 0.56 - 0.06 0.25 -
ST 0.7 1.53 - 0.07 0.48 -
% CV 0.6 10.9 - 1.9 0.6 -
n 240 240 - 240 240 -
Unit % % % % mg/dL
Mean - - 74.1 - 2.1
Sr - - 0.25 - 0.045
ST - - 0.52 - 0.081
% CV - - 0.7 - 3.8
n - - 240 - 240

level
Mean 7.375 41.5 76.6 4.85 108 4.75
Sr 0.0022 0.63 0.78 0.03 0.36 0.039
ST 0.0049 0.88 1.45 0.09 1.43 0.091
285

level
% CV - 2.1 1.9 1.9 1.3 1.9
n 240 240 240 240 240 240

level
Mean 141 99 19 15.0 93.4 3.2
Sr 0.4 1.24 0.6 0.12 0.17 0.03
ST 0.9 3.06 1.16 0.25 0.35 0.22
% CV 0.7 3.1 6.1 1.6 0.4 6.7
n 240 240 240 240 240 240

level
Unit % % % % mg/dL
Mean 3.4 6.6 89.1 41.7 7.4
Sr 0.09 0.22 0.23 2.38 0.085
ST 0.25 0.39 0.34 5.52 0.113
% CV 7.4 6.0 0.4 13.2 1.5
n 240 240 240 240 240
Mean 7.473 60.5 205.2 7.57 122 6.64
Sr 0.0027 0.87 1.92 0.12 0.31 0.035
ST 0.0052 1.18 3.65 0.22 1.32 0.070
% CV - 1.9 1.8 2.9 1.1 1.1
n 240 240 240 240 240 240
Mean 151 272 143 21.6 99.8 37.3
Sr 0.4 3.27 3.1 0.16 0.09 0.03
ST 0.9 10.4 10.6 0.21 0.16 0.24
% CV 0.6 3.8 7.4 1.0 0.2 0.7
n 240 240 240 240 240 240
286
Unit % % % % mg/dL
Mean 10.0 23.8 97.1 64.0 30.6
Sr 0.10 0.22 0.17 2.41 0.325
ST 0.22 0.47 0.23 5.53 0.417
% CV 2.2 2.0 0.2 8.6 1.4
n 240 240 240 240 240
Method comparison studies with predicate devices
Study design
Method comparison studies were performed at six user sites. The sites were not the
same for all the parameters and the measurements were not performed at the same
time. Some of the results derive from measurements started at different times and at
different sites The purpose was to evaluate whether the ABL90 FLEX analyzer is a suit-
able replacement for a current test method for each of the parameters measured by
the analyzer (pH, pCO2, pO2, cCa2+, cCl–, cK+, cNa+, cGlu, cLac, ctBil*, ctHb, sO2,
FO2Hb, FHHb, FCOHb, FMetHb, FHbF).
time.
The studies were conducted in a point-of-care setting and methods described in NCCLS
were used. "Method Comparison and Bias Estimation Using Patient Samples; Approved
Guideline – Second Edition", NCCLS EP9-A2. [12]
The material used was random patient samples and spiked blood samples. Spiked
samples were needed to support the full reportable range. In each study sample
handling and sample transfer was done by multiple POC staff members. The studies
were done in both syringe mode and capillary mode of the ABL90 FLEX analyzer.
ABL90 FLEX method comparison study results - syringe mode - site 1
Predicate device: Radiometer ABL735 analyzer.
A spiked sample is a sample that has been prepared by Radiometer. That means that
the sample may or may not have been spiked with the specific parameter.
Para Units Range Range Total n Spiked Slope Inter- R2 Sy.x

m-eter Low High n cept
pH N/A 6.859 7.692 244 114 1.02 -0.17 0.9926 0.009
pCO2 kPa 2.11 12.3 231 101 0.99 0.02 0.9942 0.13
mmHg 15.8 92.3 231 101 0.99 0.18 0.9942 0.96
pO2 kPa 4.1 63.7 208 95 1.06 -0.40 0.9978 0.48
mmHg 30.8 477.8 208 95 1.06 -3.02 0.9978 3.59
287

cCa2+ mg/dL 2.00 9.80 247 121 1.08 -0.24 0.9940 0.08
mEq/L 1.00 4.90 247 121 1.08 -0.12 0.9940 0.04
mmol/L 0.50 2.45 247 121 1.08 -0.06 0.9940 0.02
cCl– mEq/L 86 149 225 96 1.02 -2.35 0.9862 1.01
mmol/L 86 149 225 96 1.02 -2.35 0.9862 1.01
cK+ mEq/L 2.7 10.5 253 123 1.00 0.13 0.9971 0.06
mmol/L 2.7 10.5 253 123 1.00 0.13 0.9971 0.06
cNa+ mEq/L 116 176 255 125 1.07 -8.06 0.9941 0.69
mmol/L 116 176 255 125 1.07 -8.06 0.9941 0.69
cGlu mg/dL 11 648 245 117 0.91 2.62 0.9912 7.75
mmol/L 0.6 36.0 245 117 0.91 0.15 0.9912 0.43
cLac mg/dL 5 171 251 123 0.75 4.60 0.9667 4.87
mmol/L 0.5 19.0 251 123 0.75 0.51 0.9667 0.54
ctBil* mg/dL 2.8 36.9 85 9 0.992 0.36 0.989 0.651
μmol/L 48 631 85 9 0.992 6.2 0.989 11.1
ctHb g/dL 1.0 23.8 249 119 0.95 0.35 0.9929 0.29
sO2 % 6.1 99.9 233 103 1.02 -2.09 0.9984 0.65
FHHb % 2.4 98.5 157 77 1.01 0.78 0.9988 0.70
FO2Hb % 6.0 98.0 232 103 1.01 -1.44 0.9980 0.77
FCOHb % 1.0 80.3 218 95 1.00 0.07 0.9986 0.32
FMetHb % 1.0 76.3 163 39 1.00 -0.01 0.9985 0.34
FHbF % 33 62 7 7 1.05 -7.18 0.6885 6.23
in the Neonate blood analysis 65 μL mode. Predicate device: ABL835 FLEX analyzer.

pH N/A 6.840 7.774 199 95 1.04 -0.28 0.9925 0.011
pCO2 kPa 2.2 12.0 193 89 1.04 -0.15 0.9938 0.12
mmHg 16.2 90.0 193 89 1.04 -1.12 0.9938 0.89
288

pO2 kPa 4.0 59.9 178 80 1.03 -0.53 0.9988 0.28
mmHg 30.1 449.3 178 80 1.03 -3.97 0.9988 2.07
cCa2+ mg/dL 2.20 9.88 195 93 1.12 -0.44 0.9950 0.08
mEq/L 1.10 4.94 195 93 1.12 -0.22 0.9950 0.04
mmol/L 0.55 2.47 195 93 1.12 -0.11 0.9950 0.02
cCl– mEq/L 86 146 190 87 1.02 -3.75 0.9765 1.20
mmol/L 86 146 190 87 1.02 -3.75 0.9765 1.20
cK+ mEq/L 2.3 10.3 193 90 0.99 0.25 0.9938 0.09
mmol/L 2.3 10.3 193 90 0.99 0.25 0.9938 0.09
cNa+ mEq/L 119 180 195 93 1.05 -4.13 0.9878 1.01
mmol/L 119 180 195 93 1.05 -4.13 0.9878 1.01
cGlu mg/dL 18 630 194 95 0.98 -4.97 0.9986 3.44
mmol/L 1.0 35.0 194 95 0.98 -0.28 0.9986 0.19
cLac mg/dL 4 216 203 100 0.91 -0.55 0.9966 1.77
mmol/L 0.4 24.0 203 100 0.91 -0.06 0.9966 0.20
ctBil* mg/dL 0.8 35.9 51 8 1.005 0.37 0.992 0.784
μmol/L 14 614 51 8 1.005 6.4 0.992 13.4
ctHb g/dL 4.8 23.8 200 96 0.96 0.32 0.9968 0.16
sO2 % 12.1 99.6 196 92 0.99 0.59 0.9982 0.72
FHHb % 2.4 98.5 143 77 0.99 -0.04 0.9981 0.82
FO2Hb % 10.9 97.9 197 93 0.99 0.51 0.9986 0.72
FCOHb % 1.0 88.5 190 91 1.00 0.21 0.9995 0.26
FMetHb % 1.0 66.7 10 6 0.99 0.18 0.9999 0.25
FHbF % 21 78 15 15 1.02 -3.83 0.9553 4.30

pH N/A 6.840 7.712 209 82 1.01 -0.10 0.9907 0.012
289

pCO2 kPa 2.1 13.1 212 85 0.98 0.06 0.9947 0.14
mmHg 15.5 98.3 212 85 0.98 0.46 0.9947 1.02
pO2 kPa 4.1 65.0 202 76 1.02 -0.22 0.9992 0.28
mmHg 30.6 487.5 202 76 1.02 -1.63 0.9992 2.10
cCa2+ mg/dL 2.48 9.92 207 80 1.07 -0.18 0.9927 0.08
mEq/L 1.24 4.96 207 80 1.07 -0.09 0.9927 0.04
mmol/L 0.62 2.48 207 80 1.07 -0.05 0.9927 0.02
cCl– mEq/L 89 143 203 76 0.98 1.44 0.9776 1.18
mmol/L 89 143 203 76 0.98 1.44 0.9776 1.18
cK+ mEq/L 2.2 10.4 208 81 1.00 0.13 0.9972 0.06
mmol/L 2.2 10.4 208 81 1.00 0.13 0.9972 0.06
cNa+ mEq/L 119 179 207 80 1.03 -3.18 0.9923 0.70
mmol/L 119 179 207 80 1.03 -3.18 0.9923 0.70
cGlu mg/dL 16 702 216 89 0.98 -2.36 0.9987 3.00
mmol/L 0.9 39.0 216 89 0.98 -0.13 0.9987 0.17
cLac mg/dL 4 207 216 90 0.97 -0.47 0.9965 1.86
mmol/L 0.4 23.0 216 90 0.97 -0.05 0.9965 0.21
ctBil* mg/dL 1.2 35.7 74 8 0.992 1.021 0.986 0.864
μmol/L 20 611 74 8 0.992 17.4 0.986 14.8
ctHb g/dL 2.9 23.8 205 80 0.92 0.40 0.9921 0.31
sO2 % 6.6 100 197 75 1.00 -0.20 0.9992 0.50
FHHb % 2.4 92.1 168 61 1.00 -0.04 0.9991 0.53
FO2Hb % 5.5 98.5 200 77 1.00 0.00 0.9991 0.57
FCOHb % 1.0 89.3 188 66 1.00 0.35 0.9989 0.28
FMetHb % 1.0 83.3 29 11 1.00 -0.09 0.9997 0.42
FHbF % 40 76 8 8 0.99 7.61 0.8328 5.62
ABL90 FLEX method comparison study results - syringe mode -

pooled data
POC comparison test.
290

pH N/A 6.840 7.774 652 291 1.02 -0.18 0.9915 0.011
pCO2 kPa 2.1 13.1 636 275 0.99 0.04 0.9927 0.15
mmHg 15.5 98.3 636 275 0.99 0.27 0.9927 1.09
pO2 kPa 4.0 65.0 588 251 1.04 -0.39 0.9979 0.43
mmHg 30.1 487.5 588 251 1.04 -2.94 0.9979 3.25
cCa2+ mg/dL 1.00 4.96 649 294 1.10 -0.15 0.9937 0.04
mEq/L 0.50 2.48 649 294 1.10 -0.07 0.9937

0.02
mmol/L 2.00 9.94 649 294 1.10 -0.30 0.9937 0.08
cCl– mEq/L 86 149 618 259 1.00 -0.86 0.9790 1.19

-0.86
mmol/L 86 149 618 259 1.00 0.9790 1.19
cK+ mEq/L 2.2 10.5 654 294 1.00 0.17 0.9949 0.08
mmol/L 2.2 10.5 654 294 1.00 0.17 0.9949 0.08
cNa+ mEq/L 116 180 657 298 1.05 -5.91 0.9906 0.85
1.05
mmol/L 116 180 657 298 -5.91 0.9906 0.85
cGlu mg/dL 11 702 655 301 0.96 -1.16 0.9943 6.48
mmol/L 0.6 39.0 655 301 0.96 -0.06 0.9943

0.36
cLac mg/dL 4 216 670 313 0.87 1.56 0.9748 4.66
mmol/L 0.4 24.0 670 313 0.87 0.17 0.9748 0.52
ctBil* mg/dL 0.8 36.9 210 26 0.990 0.657 0.988 0.814
μmol/L 14 631 210 26 0.990 11.2 0.988 13.9
ctHb g/dL 1.0 23.8 654 295 0.95 0.34 0.9914 0.31
sO2 % 6.1 100.0 626 270 1.00 -0.45 0.9981 0.75
FHHb % 2.4 98.5 468 215 1.00 0.23 0.9980 0.84
FO2Hb % 5.5 98.5 629 273 1.00 -0.23 0.9983 0.75
FCOHb % 1.0 89.3 596 252 1.00 0.20 0.9989 0.31
FMetHb % 1.0 83.3 202 56 1.00 -0.01 0.9993 0.35
FHbF % 21 78 30 30 1.10 -5.28 0.8747 6.70
Graphical presentation of POC comparison test results - syringe mode
Pooled data from the POC comparison test.
291
292
293
294
the Neonate blood analysis 65 µL mode.
295
296
ABL90 FLEX method comparison study results - capillary mode - site

1

pH N/A 6.967 7.751 146 67 1.02 -0.14 0.9927 0.010
pCO2 kPa 2.11 12.80 152 73 1.01 -0.04 0.9970 0.11
mmHg 15.8 96.0 152 73 1.01 -0.33 0.9970 0.84
pO2 kPa 4.07 62.10 147 69 1.00 0.02 0.9987 0.34
mmHg 30.53 465.8 147 69 1.00 0.17 0.9987 2.58
cCa2+ mg/dL 2.12 9.40 132 57 0.94 0.26 0.9691 0.13
mEq/L 1.06 4.70 132 57 0.94 0.13 0.9691 0.06
mmol/L 0.53 2.35 132 57 0.94 0.07 0.9691 0.03
cCl– mEq/L 86 150 147 69 1.00 -0.85 0.9829 1.29
mmol/L 86 150 147 69 1.00 -0.85 0.9829 1.29
297

cK+ mEq/L 2.1 9.9 148 71 0.99 -0.05 0.9984 0.05
mmol/L 2.1 9.9 148 71 0.99 -0.05 0.9984 0.05
cNa+ mEq/L 118 176 150 73 1.06 -7.66 0.9933 0.67
mmol/L 118 176 150 73 1.06 -7.66 0.9933 0.67
cGlu mg/dL 13 738 154 77 1.01 -2.42 0.9969 5.99
mmol/L 0.7 41.0 154 77 1.01 -0.13 0.9969 0.33
cLac mg/dL 4 180 148 75 1.02 -0.97 0.9795 4.13
mmol/L 0.4 20.0 148 75 1.02 -0.11 0.9795 0.46
ctBil* mg/dL 2.8 36.9 91 9 0.974 0.49 0.984 0.760
μmol/L 48 631 91 9 0.974 8.3 0.984 13.0
ctHb g/dL 0.6 24.0 153 76 1.00 0.25 0.9972 0.20
sO2 % 11.8 100 145 70 1.02 -2.75 0.9979 0.74
FHHb % 2.5 97.1 102 54 1.01 0.95 0.9985 0.71
FO2Hb % 3.7 98.5 147 72 1.01 -0.59 0.9981 0.93
FCOHb % 1.0 92.2 78 39 1.01 -0.54 0.9992 0.46
FMetHb % 1.0 89.4 69 16 1.01 -0.39 0.9993 0.44
FHbF % 21 74 10 7 1.54 -17.2 0.9480 4.98
in the Neonate blood analysis 65 μL mode. Predicate device: ABL835 FLEX analyzer.

2

pH N/A 6.824 7.763 150 74 0.98 0.18 0.9908 0.012
pCO2 kPa 2.12 12.8 147 70 0.93 0.19 0.9900 0.18
mmHg 15.9 96.0 147 70 0.93 1.42 0.9900 1.32
pO2 kPa 4.25 62.2 135 58 0.97 0.48 0.9947 0.68
mmHg 31.9 466.5 135 58 0.97 3.63 0.9947 5.09
cCa2+ mg/dL 2.04 9.12 142 66 0.91 0.38 0.9892 0.08
mEq/L 1.02 4.56 142 66 0.91 0.19 0.9892 0.04
mmol/L 0.51 2.28 142 66 0.91 0.10 0.9892 0.02
298

cCl– mEq/L 87 150 140 63 0.96 5.05 0.9516 1.80
mmol/L 87 150 140 63 0.96 5.05 0.9516 1.80
cK+ mEq/L 2.1 10.5 149 72 1.01 -0.10 0.9982 0.07
mmol/L 2.1 10.5 149 72 1.01 -0.10 0.9982 0.07
cNa+ mEq/L 121 174 147 70 1.06 -7.88 0.9873 0.91
mmol/L 121 174 147 70 1.06 -7.88 0.9873 0.91
cGlu mg/dL 9 702 147 70 1.01 -1.05 0.9963 5.54
mmol/L 0.5 39.0 147 70 1.01 -0.06 0.9963 0.31
cLac mg/dL 5 198 138 63 1.05 -0.83 0.9965 1.81
mmol/L 0.5 22.0 138 63 1.05 -0.09 0.9965 0.20
ctBil* mg/dL 0.8 35.9 56 9 0.998 0.54 0.993 0.744
μmol/L 14 614 56 9 0.998 9.2 0.993 12.7
ctHb g/dL 2.6 24.0 149 73 0.99 0.11 0.9919 0.30
sO2 % 13.9 100 145 69 1.00 -0.11 0.9975 0.79
FHHb % 2.5 96.8 110 51 1.00 0.17 0.9978 0.83
FO2Hb % 7.5 98.5 140 66 0.99 0.49 0.9986 0.76
FCOHb % 1.0 91.7 67 34 1.01 -0.47 0.9995 0.38
FMetHb % 1.0 91.0 76 17 0.99 0.55 0.9989 0.54
FHbF % 23 73 7 7 0.80 15.8 0.9584 4.63
in the Neonate blood analysis 65 μL mode. Predicate device: Radiometer ABL835 FLEX
analyzer.

3

pH N/A 6.898 7.797 169 81 0.98 0.16 0.9884 0.014
pCO2 kPa 2.06 12.9 166 78 0.92 0.25 0.9923 0.18
mmHg 15.5 96.8 166 78 0.92 1.90 0.9923 1.34
pO2 kPa 4.12 57.2 159 72 1.01 -0.04 0.9986 0.32
mmHg 30.9 429.0 159 72 1.01 -0.31 0.9986 2.39
299

cCa2+ mg/dL 2.48 9.48 164 77 1.03 -0.16 0.9864 0.08
mEq/L 1.24 4.74 164 77 1.03 -0.08 0.9864 0.04
mmol/L 0.62 2.37 164 77 1.03 -0.04 0.9864 0.02
cCl– mEq/L 86 150 159 71 1.01 -1.76 0.9766 1.46
mmol/L 86 150 159 71 1.01 -1.76 0.9766 1.46
cK+ mEq/L 3.2 10.0 161 74 1.04 -0.10 0.9960 0.08
mmol/L 3.2 10.0 161 74 1.04 -0.10 0.9960 0.08
cNa+ mEq/L 117 176 165 78 1.08 -9.46 0.9885 0.89
mmol/L 117 176 165 78 1.08 -9.46 0.9885 0.89
cGlu mg/dL 9 684 165 78 0.97 -0.57 0.9969 5.13
mmol/L 0.5 38.0 165 78 0.97 -0.03 0.9969 0.28
cLac mg/dL 4 198 161 77 1.08 -2.96 0.9708 5.52
mmol/L 0.4 22.0 161 77 1.08 -0.33 0.9708 0.61
ctBil* mg/dL 1.1 35.7 77 8 0.977 1.12 0.985 0.866
μmol/L 18 611 77 8 0.977 19.1 0.985 14.8
ctHb g/dL 0.6 23.5 166 79 0.98 0.16 0.9973 0.20
sO2 % 12.1 99.9 160 73 0.98 1.33 0.9986 0.53
FHHb % 2.4 98.5 119 57 0.99 0.20 0.9990 0.62
FO2Hb % 7.2 98.5 159 72 0.99 1.13 0.9988 0.65
FCOHb % 1.0 91.7 53 37 1.00 -0.39 0.9995 0.45
FMetHb % 1.0 90.2 101 30 0.99 0.54 0.9988 0.49
FHbF % 35 83 8 8 1.04 -3.48 0.7901 7.96
ABL90 FLEX method comparison study results - capillary mode -

pooled data
POC comparison test.

pH N/A 6.824 7.797 465 222 0.99 0.09 0.9898 0.012
pCO2 kPa 2.1 12.9 465 221 0.95 0.14 0.9895 0.20
mmHg 15.5 96.8 465 221 0.95 1.04 0.9895 1.51
300

pO2 kPa 4.1 62.2 441 199 0.99 0.17 0.9969 0.50
mmHg 30.5 466.5 441 199 0.99 1.26 0.9969 3.75
cCa2+ mg/dL 1.02 4.74 438 200 0.96 0.09 0.9795 0.05
mEq/L 0.51 2.37 438 200 0.96 0.04 0.9795 0.03
mmol/L 2.04 9.50 438 200 0.96 0.18 0.9795 0.11
cCl– mEq/L 86 150 446 203 1.00 -0.12 0.9663 1.71
mmol/L 86 150 446 203 1.00 -0.12 0.9663 1.71
cK+ mEq/L 2.1 10.5 458 217 1.01 -0.06 0.9952 0.09
mmol/L 2.1 10.5 458 217 1.01 -0.06 0.9952 0.09
cNa+ mEq/L 117 176 462 221 1.07 -8.49 0.9870 0.93
mmol/L 117 176 462 221 1.07 -8.49 0.9870 0.93
cGlu mg/dL 9 738 466 225 1.00 -1.43 0.9962 6.02
mmol/L 0.5 41.0 466 225 1.00 -0.08 0.9962 0.33
cLac mg/dL 4 198 447 215 1.05 -1.71 0.9805 4.28
mmol/L 0.4 22.0 447 215 1.05 -0.19 0.9805 0.48
ctBil* mg/dL 0.8 36.9 224 26 0.976 0.77 0.986 0.846
μmol/L 14 631 224 26 0.976 13.2 0.986 14.5
ctHb g/dL 0.6 24.0 468 228 0.99 0.20 0.9947 0.27
sO2 % 11.8 100.0 450 212 1.00 -0.55 0.9973 0.78
FHHb % 2.4 98.5 331 162 1.00 0.43 0.9978 0.87
FO2Hb % 3.7 98.5 446 210 1.00 0.30 0.9984 0.81
FCOHb % 1.0 92.2 198 110 1.01 -0.48 0.9994 0.43
FMetHb % 1.0 91.0 246 63 1.00 0.29 0.9984 0.63
FHbF % 21 83 25 22 0.95 5.62 0.8298 8.17
Graphical presentation of POC comparison test results - capillary

mode
Pooled data from the POC comparison test.
301
302
303
304
the Neonate blood analysis 65 µL mode.
305
306
Traceability
Traceability to the primary standards at Radiometer
The Metrology Department at Radiometer is responsible for establishing metrological

traceability for the measured parameters [25].
pH traceability
The primary pH standards are traceable to the definitive method for pH. The definitive
method is based on a Hydrogen Electrode System. The primary pH standards are
obtained from the Danish primary laboratory for Electrochemistry (DPLEC) at the
Danish Institute of Fundamental Metrology (DFM). This primary laboratory is accredited
by Danish Accreditation (DANAK accreditation no. 255). Certification is done in accord-
ance with the method recommended by the International Union of Pure and Applied
Chemistry (IUPAC). The Hydrogen Electrode System of DLPEC is validated by compar-
ison with Standard Reference Materials (SRMs) produced by the National Institute of
Standards and Technology (NIST). The primary standards are therefore also traceable
to NIST.
The IUPAC-recommended method is described in [26].
The NIST SRMs used are: 186I/II-g, 185g, 187e, 191-I-d and 191_II-d.
Using the primary pH standards, the secondary pH standards are certified in the
Metrology Section. These are normally of the same composition as the primary buffers,
tapped into 2-mL glass ampoules and heat sterilized. The secondary buffers are stored
307
at 5 °C. Measurements of the secondary buffers are done using a glass electrode with
a saturated calomel reference electrode and a liquid junction of saturated KCl. The
liquid junction is a vertical, cylindrical and open liquid junction. Measurement of a
secondary buffer is done using a primary buffer together with a certified secondary
buffer as standards for making a 2-point calibration of the glass electrode arrange-
ment.
pCO2 and pO2 traceability
The primary gases used are Standard Reference Materials (SRMs) produced by NIST.
The NIST SRMs used are: 1674b and 2658a. The NIST SRM gases are used to validate
primary gravimetric working gas standards, certified by Air Products. The primary
gravimetric working gas standards are validated using a computer-controlled gas chro-
matography system, introducing the NIST SRM gases as samples and comparing the
obtained results with the certified values.
The primary gravimetric working gas standards are used as standards in the gas chro-
matography system, so that the composition of secondary working gas standards can
be determined.
By using the secondary working gas standards in a tonometer together with an

aqueous buffer solution, a solution with a known pCO2 and pO2 is produced. This
aqueous buffer solution is then used to determine the pCO2 and pO2 of secondary
working standards. These secondary working standards are aqueous buffer solutions
kept in 2-mL ampoules.
cK+ and cNa+ traceability
The primary working standards used are gravimetric standards produced from KCl and
NaCl Suprapur, produced by Merck. These primary working standards are validated
using Standard Reference Materials (SRMs) produced by NIST, so that traceability to
NIST is achieved. The NIST SRMs used are: 919b (NaCl) and 999b (KCl). Validation of
the primary working standards is done using a flame photometer together with the
NIST SRMs.
The flame photometer method of validating the primary working standards is described
in [27].
The primary working standards are used to determine the sodium and potassium
concentrations of the secondary working standards. The concentrations of the secon-
dary working standards are measured using a flame photometer.
cCa2+ traceability
The primary standards used are the so-called Ca2+ transfer standards, produced from
NIST SRM 915b. The transfer standards are pH-stabilized to pH = 7.4, with 1 mmol/L
HEPES and an ionic strength of 160.0 mmol per kg. Validation of the Ca2+ transfer
standards is done using similar standards produced from NIST SRM 915b.
The transfer standards are used to determine the calcium concentrations of secondary
standards. These measurements take place using ion-selective Ca electrodes on the
ABL735 analyzer.
cCl– traceability
The primary working standards are gravimetric standards, prepared from KCl Suprapur,
produced by Merck. The primary working standards are validated by making compara-
tive titrations using similar standards prepared from NIST SRM 999b (KCl). The titra-
tions are done using an AgNO3 solution as the titrant, and potentiometric titration
equipment.
308
The standardized AgNO3 solution is used as the titrant for the determination of the
chloride concentration of the secondary standards, using the potentiometric titrator
(Titrando 900 from Metrohm, Switzerland).
cGlu traceability
The primary working standards are prepared from NIST SRM 917c (D-glucose). These
primary standards are used to determine the glucose concentration of secondary
standards. The measurements take place using the glucose reference method, which is
the hexokinase/glucose-6-phosphate dehydrogenase method recommended by CLSI.
This method is described in [7].
cLac traceability
No certified standard reference material for lactate is available at present. The primary
working standards are therefore prepared from a pure commercially available material,
namely the Lithium salt of L(+) Lactic Acid (Cat. No. L-2250) supplied by the Sigma
Chemical Company.
These primary standards are used to determine the lactate concentration of secondary
standards.
The measurements take place using a spectrophotometric method. The method is

based on a reaction of lactate, catalyzed by L-Lactate Dehydrogenase (LDH). The reac-
tion produces dihydronicotinamide (NADH), which is measured at 339 nm. The method
is described in [8].
ctHb traceability
The primary standard used is an oxygenated blood sample. The ctHb value of this
sample is determined by the use of the HiCN reference method. This method is
described in [28]. The HiCN reference method is a spectrophotometric method. The
spectrophotometer used is calibrated using a NIST SRM 930D filter. This method is
further validated using the certified reference material Hemoglobin-cyanide standard
(BCR - 522, Institute for Reference Materials and Measurements, Belgium).
The primary standard is used to calibrate the ABL735 reference instruments.
Saturation – sO2 = 100 % – traceability
The primary working standard used is a blood sample, with the ctHb value adjusted to
between 13 and 15 g/dL The blood sample is tonometered with 5.6 % CO2 – 94.4 %
O2, traceable to NIST SRM gases.
The primary standard is used to calibrate the ABL735 reference instruments.
Saturation – sO2 = 0 % – traceability
The primary working standard used is a blood sample. The blood sample is deoxygen-
ated by the use of Argon and treated with a dithionite solution.
The primary working standard is used to calibrate the ABL735 reference instruments.
FCOHb – normal value - traceability
The primary standards used are CO with atmospheric air mixtures, produced in a
container of known volume. The CO used for making these gas mixtures has a certified
purity of 99.997 %. Validation of the mixing method is done by comparison with NIST
SRM 1678 (50 ppm CO in N2).
309
The produced mixtures are used as calibration standards in connection with a gas chro-
matography method. The gas sample, injected into the gas chromatograph, is the gas
phase of a blood sample from a closed test tube, in which the blood sample has been
treated so that all the bound CO is released from the hemoglobin. The analyzed result
is measured in % CO, and from this the FHbCO is calculated. The method is described
in [29].
The measured blood sample is used as secondary standard and is used to calibrate the
ABL735 reference instruments.
FCOHb – 100 % - traceability
The primary working standard used is a blood sample. The blood sample is tonome-
tered with 100 % CO, with a certified purity of 99.997 % CO. The primary working
standard is used to calibrate the ABL735 reference instruments.
FMetHb traceability
The primary working standard is a blood sample. The FMetHb is determined using the
KCN addition method according to Evelyn and Malloy [10]. This method is a spectro-
photometric method, where the absorbance measurements are done at 630 nm (local
peak for MetHb) on two sets of solutions, prepared from the blood sample. The first set
allows determination of the relative MetHb content, whereas ctHb is determined from
the second set. From these measurements, the FMetHb of the blood sample can be
calculated.
FHbF traceability
The primary working standard is a blood sample. The FHbF of this sample is deter-
mined using the Cation Exchange HPLC reference method. The method is described in
[11]. The method is performed by the Hematology Laboratory at Herlev Hospital,
Denmark.
Hct traceability
Reference method: Radiometer uses a reference method based on the

packed-cell-volume procedure described by the Clinical and Laboratory Standards Insti-
tute [30]. The packed-cell volume is the measure of the ratio of the volume occupied
by the red cells to the volume of blood in a sample of capillary or venous blood. The
ratio is measured after appropriate centrifugation.
Radiometer measurements: The Hct measurement is based on conductivity meas-

ured in a sample and then corrected for the presence of sodium ions. A Sigma 201
Micro hematocrit centrifuge with RCF of 12620*g, which meets most of the CLSI
requirements, has been used for the test together with 75 mm Microhematocrit capil-
lary tubes with an inner diameter between 1.1 and 1.2 mm. The centrifugation time
has been 5 minutes.
The conductivity and sodium concentration have been measured on approximately

1000 blood samples with a sodium concentration varying from 80 mmol/L to 180
mmol/L. Hct measurements have then been correlated to the Hct measured by the
reference method.
ctBil* traceability
The primary working standard is a blood sample. The total neonatal bilirubin* is deter-
mined on a serum sample prepared from this. The determination is performed using a
Hitachi 717 wet-chemistry analyzer, which uses the Boehringer Mannheim reagency kit,
DPD method, given in [18]. The reference instrument is calibrated using four levels of
NIST SRM916a unconjugated bilirubin standard material.
310
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17. Vanderline RE, Goodwine J, Koch D, Scheer D, Steindel S, Cembrowski G. Guide-
lines for providing quality stat laboratory services. 1987 Laboratory Quality Assur-
ance Commitee.
18. Wahlefeld AW, Herz G, Bernt E. Modification of the Malloy-Evelyn method for a
simple, reliable determination of total bilirubin in serum. Scand J Clin Lab Invest
1972;29 Supplement 126: Abstract 11:12.
19. Burtis CA, Ashwood ER, Bruns DE. Tietz textbook of clinical chemistry and molec-
ular diagnostics. 5th ed. St. Louis: Saunders Elsevier, 2012.
20. Siggaard-Andersen O, Thode J, Wandrup JH. The concentration of free calcium ions
in the blood plasma ionized calcium. In: Siggaard-Andersen O, ed. Proceedings of
the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980. Copen-
hagen: Radiometer Medical A/S, 1981: 163-90. Available as AS79.
21. NCCLS Interference testing in Clinical Chemistry Approved Guideline - Second
Edition, EP7-A2, 2005. Chapter 5.4 Potential Interfering Substances.
22. CLSI approved guideline for interference testing in clinical chemistry, EP7-A, Vol.
22, No. 27.
311
23. Giegy Scientific Tables, Physical Chemistry, Composition of Blood, Hematology,

Somametric Data, Ciba-GEIGY, 1984; 3, 207.
24. CLSI Protocols for Determination of Limits of Detection and Limits of Quantitation;
Approved Guidelines, EP17-A, Vol. 24, No. 34.
25. Kristensen H.B. Traceability to the primary reference standards at Radiometer.
Copenhagen: Radiometer Medical ApS, 2004. Code 918-541.
26. Measurement of pH. Definition, standards, and procedures. (IUPAC Recommenda-
tions 2002). Pure and Appl Chem 2002; 74, 11: 2169-2200.
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312
Derived and input parameters 11
Parameter types
Some parameters are measured by the analyzer, others are calculated from equations
that use measured / keyed-in / default values of other parameters.
Parameter type Description
Measured parameters Parameters that are measured by the analyzer
Input parameters Parameters that are keyed-in (entered) by an operator
Derived parameters Parameters that are calculated from measured, input and default values
Parameter symbols
The symbols for the parameters are based on the principles described by Wandrup [1].
Each symbol has three parts:
1 A character in italics that is an abbreviation of the property Examples:

(quantity) • p for pressure
• c for concentration
• F for fraction
• V for volume
2 An abbreviation of the parameter Examples:

• O2 for oxygen
• CO2 for carbon dioxide
• COHb for carboxyhemoglobin
3 A character that is an abbreviation of the system • B for blood

• P for plasma
• a for arterial blood
• v̄ for mixed venous blood
• A for alveolar air
• T for patient temperature
Example:
pO2(a), where p = pressure, O2 = oxygen, (a) = arterial blood.
Input parameters – definitions and acceptable values
Input parameters are parameter values that can be entered by operators, or trans-
ferred to the analyzer from an interfaced database. Only values that fall within a given
range are accepted.
313
Chapter 11: Derived and input parameters ABL90 FLEX: Instructions for use
Parameter Definition Unit Input range

symbol
T Patient temperature °C 15.0-45.0
°F 59.0-113.0
N/A Temperature °C 18.0-32.0

Note: This is a data field in the Quality control
°F 64.4-89.6
identification screen. To get the correct QC
results, it is necessary that the ampoule tempera-
ture is entered in this field.
FO2(I) Fraction of oxygen in dry inspired air % 0-100
Fraction 0.000-1.000
ctHb Concentration of total hemoglobin in blood. g/dL 0.0-33.0

Note: Is used if the analyzer version does not
g/L 0-330
include the oximetry measuring system.
mmol/L 0.0-20.5
RQ Respiratory quotient, ratio between the CO2 Fraction 0.00-2.00

production and the O2 consumption
pO2(v)̄ Oxygen tension of mixed venous blood mmHg; Torr 0.0-750.0
kPa 0.00-100
sO2(v)̄ Oxygen saturation of mixed venous blood % 0.0-100.0
Q̇t Cardiac output; volume of blood delivered from the L/min 0.0-100.0
left ventricle into the aorta per unit of time.
Note: Also termed CO or C.O.
V̇O2 Oxygen consumption; total amount of oxygen used mL/min 0-21000

by the whole organism per unit of time
mmol/min 0.0-937.1
VCO Volume of carbon monoxide added to the patient mL 0.0-1000.0

for measurement and calculation of V(B) [5]
FCOHb(1) The fraction of COHb measured before a CO injec- % 0.0-100.0

tion
FCOHb(2) The fraction of COHb measured after a CO injection % 0.0-100.0
Derived parameters
Derived parameters are calculated from equations that can include the measured
and/or input (keyed-in) values of other parameters. The accuracy of derived parame-
ters depends on the accuracy and availability of these values.
There are two types of derived parameter:
314
ABL90 FLEX: Instructions for use Chapter 11: Derived and input parameters
Derived Explanation Symbols on derived

parameter parameter results
type
Calculated Necessary measured and keyed-in values are avail- Subscript c.

able
For example: x.xxxc
mmol/L
Estimated Necessary keyed-in and/or measured values are not Subscript e.

available. Default values are used.
For example: x.xxxe
mmol/L
Note: Default values are only used for missing
measured values, when they are clinically appro-
priate.
Note: Estimated oxygen status parameter values

may deviate significantly from the true values.
Note: When a necessary measured value is outside the range of indication*, no default
value is used. No result is given for the derived parameter.
Default values of parameters
Parameter values that are necessary in order to calculate derived parameters are given
a default value when no other value is available.
Parameter Parameter Description Default value When is the

symbol /name type default used?
T Input Patient temperature 37.0 °C When no value is

entered
(98.6 °F)
Temperature Input Ambient temperature 25.0 °C When no value is

entered
(77 °F)
Note: This is a data field in the
Quality control identification
screen. To get the correct QC results,
it is necessary that the room tempera-
ture is entered in this field.
FO2(I) Input Fraction/(%) of oxygen in dry inspired 0.21 When no value is

air entered
(21.0 %)
RQ Input Respiratory quotient, ratio between 0.86 When no value is

the CO2 production and the O2 entered
consumption
ctHb Measured Concentration of total hemoglobin in 9.3087 When the param-

blood mmol/L, (15.00 eter cannot be
g/dL or 150 measured
g/L)
315
Parameter Parameter Description Default value When is the

symbol /name type default used?
FCOHb Measured Fraction/(%) of carboxyhemoglobin in 0.004/ When the param-

total hemoglobin in blood eter cannot be
(0.4 %) measured
FMetHb Measured Fraction/(%) of methemoglobin in 0.004/ When the param-

total hemoglobin in blood eter cannot be
(0.4 %) measured
p50(st) Derived Partial pressure (or tension) of oxygen 3.578 kPa When the param-
at half saturation (50%) in blood (26.84 mmHg) eter cannot be
under standard conditions: derived
• T= 37 °C
• pH = 7.40
• pCO2 = 5.33 kPa
• FCOHb, FMetHb, FHbF are set to
zero
Definitions of derived parameters
Acid-base derived parameters – definitions
Symbol Definition
pH(T) pH of blood at patient temperature
cH+(T) Concentration of hydrogen ions in blood at patient temperature
pCO2(T) Partial pressure (or tension) of carbon dioxide at patient temperature
cHCO3–(P) Concentration of hydrogen carbonate in plasma (also termed actual bicar-

bonate)
cBase(B) Actual Base Excess, the concentration of titrable base when the blood is
titrated with a strong base or acid to a plasma pH of 7.40, at pCO2 of 5.33 kPa
or ABE (40 mmHg) and 37 °C, at the actual oxygen saturation [2,3,4]. Positive values
(base excess) indicate a relative deficit of noncarbonic acids; negative values
(base deficit) indicate a relative excess of noncarbonic acids.
cBase(B,ox) cBase(B) of fully oxygenated blood
cBase(Ecf) Standard Base Excess, an in vivo expression of base excess [3,4,5]. It refers
to a model of the extracellular fluid (one part of blood is diluted by two parts of
or SBE its own plasma) and is calculated using a standard value for the hemoglobin
concentration of the total extracellular fluid.
cBase(Ecf,ox) cBase(Ecf) of fully oxygenated blood
cHCO3–(P,st) Standard Bicarbonate, the concentration of hydrogen carbonate in the plasma

from blood that is equilibrated with a gas mixture with pCO2 = 5.33 kPa (40
mmHg) and pO2 ≥13.33 kPa (100 mmHg) at 37 °C [2,3]
ctCO2(P) Concentration of total carbon dioxide, (free CO2 + bound CO2) in plasma
ctCO2(B) Concentration of total carbon dioxide in blood (also termed CO2 content).
Calculated based on the total CO2 concentrations in the two phases: plasma
and erythrocyte fluid [3].
316
Symbol Definition
pH(st) Standard pH (or eucapnic pH), defined as the pH of plasma of blood equili-
brated to pCO2 = 5.33 kPa (40 mmHg). By ensuring the normal value of pCO2,
the respiratory influence from pH is removed, and pH(P,st) therefore reflects
the metabolic status of the blood plasma.
VCO2/V(dry air) The volume fraction of carbon dioxide in dry air
Oximetry derived parameters – definitions
The oximetry parameters are only derived if the analyzer cannot measure them.
Parameter Definition
FHHb Fraction of deoxyhemoglobin in total hemoglobin in blood. Deoxyhemoglobin is the

part of total hemoglobin which can bind oxygen, and thus forms oxyhemoglobin. It
is also termed reduced hemoglobin, RHb.
FO2Hb Fraction of oxyhemoglobin in total hemoglobin in blood
sO2 Oxygen saturation, the ratio between the concentrations of oxyhemoglobin and the
hemoglobin minus the dyshemoglobins
Hct Hematocrit, the ratio between the volume of erythrocytes and the volume of blood
Oxygen derived parameters - definitions
Symbol Definition
pO2(T) Partial pressure (or tension) of oxygen at patient temperature
pO2(A) Partial pressure (or tension) of oxygen in alveolar air
pO2(A,T) Partial pressure (or tension) of oxygen in alveolar air at patient temperature
pO2(a)/FO2(I) Oxygen tension ratio of arterial blood and the fraction of oxygen in dry
inspired air
pO2(a,T)/ FO2(I) Oxygen tension ratio of arterial blood at patient temperature and the fraction
of oxygen in dry inspired air
p50 Partial pressure (or tension) of oxygen at half saturation (50%) in blood.
High and low values indicate decreased and increased affinity of oxygen to
hemoglobin, respectively.
p50(T) Partial pressure (or tension) of oxygen at half saturation (50%) in blood at
patient temperature
p50(st) Partial pressure (or tension) of oxygen at half saturation (50%) in blood at
standard conditions:
T = 37 °C
pH = 7.40
pCO2 = 5.33 kPa
FCOHb, FMetHb, FHbF are set to zero.
p50(st) may, however, vary due to variations in 2,3-DPG concentration or to

the presence of abnormal hemoglobins.
317
Symbol Definition
pO2(A-a) Difference in the partial pressure (or tension) of oxygen in alveolar air and
arterial blood.
Indicates the efficacy of the oxygenation process in the lungs.
pO2(A-a,T) Difference in the partial pressure (or tension) of oxygen in alveolar air and
arterial blood at patient temperature
pO2(a/A) Ratio of the partial pressure (or tension) of oxygen in arterial blood and
alveolar air.
Indicates the efficacy of the oxygenation process in the lungs.
pO2(a/A,T) Ratio of the partial pressure (or tension) of oxygen in arterial blood and
alveolar air at patient temperature
pO2(x) or px Oxygen extraction tension of arterial blood.
Reflects the integrated effects of changes in the arterial pO2(a), ctO2 and p50
on the ability of arterial blood to release O2 to the tissues [6].
pO2(x,T) or px(T) Oxygen extraction tension of arterial blood at patient temperature
ctO2(B) Total oxygen concentration of blood.
Also termed O2 content.
ctO2(a-v)̄ Oxygen concentration difference between arterial and mixed venous blood
BO2 Hemoglobin oxygen capacity; the maximum concentration of oxygen bound

to hemoglobin in blood saturated, so that all deoxyhemoglobin is converted
to oxyhemoglobin.
ctO2(x) Extractable oxygen concentration of arterial blood.
Defined as the amount of O2 that can be extracted per liter of arterial blood
at an oxygen tension of 5.0 kPa (38 mmHg), which maintains a constant pH
and pCO2 [6].
ḊO2 Oxygen delivery; the total amount of oxygen delivered to the whole organism
per unit of time
Q̇t Cardiac output; volume of blood delivered from the left ventricle into the
aorta per unit of time.
Also termed CO or C.O.
̇ 2
VO Oxygen consumption; total amount of oxygen utilized by the whole organism
per unit of time
FO2(I) Fraction of oxygen in dry inspired air
FShunt Relative physiological shunt or concentration-based shunt [3,6,7].

• Calculated from the pulmonary shunt equation:
·
Qs 1
=
·
ctO2 (a - v)
Qt 1+
ctO2 (A) - ctO2 (a) if both arterial and mixed venous blood
samples are used.

• May be estimated from one arterial sample by assuming a constant differ-
ence in the concentrations of total oxygen in arterial and mixed venous
blood: ctO2(a-v)̄ = 2.3 mmol/L (5.15 mL/dL)
FShunt(T) FShunt at patient temperature
318
Symbol Definition
RI Respiratory Index; ratio between the oxygen tension difference of alveolar air
and arterial blood and the oxygen tension of arterial blood.
RI(T) Respiratory Index; ratio between the oxygen tension difference of alveolar air
and arterial blood and the oxygen tension of arterial blood at patient temper-
ature.
VO2/V(dry air) Volume fraction of oxygen in dry air
Qx Cardiac oxygen compensation factor of arterial blood defined as the factor by

which the cardiac output should increase to allow release of 2.3 mmol/L (5.1
mL/dL) oxygen at a mixed venous pO2 of 5.0 kPa (38 mmHg) [3,6]
V(B) Volume of blood, calculated when FCOHb and V(CO) values are keyed in [3]
Electrolyte derived parameters – definitions
Parameter Definition
Anion Gap,K+ Difference between the concentration of the cations (sodium and potassium),
and the measured anions (chloride and bicarbonate)
Anion Gap Difference between the concentration of the cation (sodium), and the measured
anions (chloride and bicarbonate)
cCa2+(7.4) Concentration of calcium cations at pH = 7.40
mOsm [1/1000] × Number of moles of ions that contribute to the osmotic pressure of a
solution
Data necessary to derive electrolyte parameters
The table shows the measured parameters that are necessary to calculate the derived
electrolyte parameters.
Parameter Unit Necessary measured

parameters
Anion Gap, K+ mmol/L, meq/L cK+, cNa+, cCl-
Anion Gap mmol/L, meq/L cNa+, cCl-
cCa2+(7.4) mmol/L, meq/L, mg/dL pH, cCa2+

Note: pH must be between
7.2-7.6 to calculate this
parameter.
mOsm mmol/kg cNa+, cGlu
Calculation of derived parameters
Sample type
Unless otherwise stated, a derived parameter will be calculated or estimated irrespec-

tive of the sample type selected on the Patient identification screen:
319
• Arterial
• Capillary
• Venous
• Mixed venous
• Cord blood arterial
• Cord blood venous
• Fetal scalp
• Not specified
Some parameters, however, are defined for arterial or capillary samples only; they will
be calculated only for sample types entered as “Arterial” or “Capillary”.
The symbol for system (blood (B) or plasma (P)) is not stated in the equations unless it
is important for the calculation.
Units and symbols used in equations
All definitions and equations are based on SI units. If "T" for patient temperature is not
stated, the calculation is based on a temperature of 37.0 °C.
The following SI units are used:
Description Unit
Concentration mmol/L
Temperature °C
Pressure kPa
Fractions - (not %)
The following symbols are used in the equations:
log(x) = log10(x)
ln(x) = loge(x)
Equations
Equations for acid-base parameters
pH(T) - equation 1
Ref. [13]:
pH(T) = pH(37) - [0.0147 + 0.0065 × (pH(37) - 7.40)][T - 37]

Note: The equation is different from that of previous Radiometer analyzers. The
constant 0.0146 is now changed to 0.0147, to be in accordance with NCCLS
(CLSI)-approved guidelines [8].
The change corresponds to -0.1 mpH/°C.
cH+(T) - equation 2
cH+(T) = 10(9-pH (T))
320
pCO2(T) - equation 3
Ref. [4]:
pCO2(T) = pCO2(37) × 10[0.019 x (T-37)]
constant 0.021 is now changed to 0.019, to be in accordance with NCCLS
(CLSI)-approved guidelines [2].
The change corresponds to 2 %/5 °C.
cHCO3–(P) - equation 4
Ref. [19]:
cHCO3–(P) = 0.23 × pCO2 × 10[pH-pKp)
where pKp = 6.095
cHCO3–(P) includes ions of hydrogen carbonate, carbonate and carbamate in the

plasma.
Note: The equation is different from that of previous Radiometer analyzers. The pKp is
now constant, to be in accordance with NCCLS (CLSI)-approved guidelines [4].
The change corresponds to 5 % in the pH range 7-7.8.
cBase(B) - equation 5
Ref. [4]:
cBase(B) = (1 - 0.014ctHb)(cHCO3-(P) - 24.8 + (1.43 ctHb + 7.7)(pH - 7.4))

Note: The equation is different from that of previous Radiometer analyzers. The calcu-
lation is done in accordance with NCCLS (CLSI)-approved guidelines [5].
However, the previous method [9] is considered a better method. The change corre-
sponds to less than 0.6 mmol/L in the reference ranges for pH, pCO2 and ctHb. The
previous range checks are retained. Outside the ±50 mmol/L range, no values are
displayed. Outside the range ±30 mmol/L, values are tagged with ?.
cBase(B,ox) - equation 6
Ref. [2]:
cBase(B,ox) = cBase(B) - 0.3062 × ctHb × (1 - sO2)
If ctHb is not measured or keyed in, the default value will be used.
If sO2 is not measured, it will be calculated from equation 39.
cBase(Ecf) - equation 7
Ref. [5]:
cBase(Ecf) = cHCO3–(P) - 24.8 + 16.2 (pH - 7.4)
See the note in equation 5.
cBase(Ecf,ox) - equation 8
cBase(Ecf,ox) = cBase(Ecf) - 0.3062 × 3 × (1 - sO2)
321
cHCO3–(P,st) - equation 9
Refs. [2,9]:
cHCO3–(P,st) = 24.47 + 0.919 × Z + Z x a' × (Z - 8)
Where
Equation Description
9.1 a' = 4.04 × 10-3 + 4.25 × 10-4 × ctHb
9.2 Z = cBase(B) - 0.3062 × ctHb × (1 - sO2)
ctCO2(P) - equation 10
Refs. [4,5]:
ctCO2(P) = 0.23 x pCO2 + cHCO3-(P)
ctCO2(B) - equation 11
Ref. [3]:
(pH -pK ) æ ctHb ö
ctCO2 (B) = 9.286 ´ 10-3 ´ pCO2 ´ ctHb ´ é1 + 10 Ery Ery ù + ctCO2 (P ) ´ ç1 -
ëê ûú è 21.0 ÷ø
where
11.1 pHEry = 7.19 + 0.77 × (pH - 7.40) + 0.035 × (1 - sO2)
11.2 pKEry= 6.095 - log[1+10(pHEry - 7.84 - 0.06 × sO2)]
pH(st) - equation 12
Ref. [9]:
pH (st): see equations 5.3-5.5.
5.3
æ 5.33 ö æ pH(Hb) - pH ö
pH(st) = pH + log ç ÷´ç ÷
è p CO2 ø è log p CO2 (Hb) - log(7.5006 p CO )
2 ø
5.4 pH(Hb) = 4.06 × 10-2ctHb + 5.98 - 1.92 × 10(-0.16169ctHb)
5.5 log pCO2(Hb) = -1.7674 × 10-2ctHb + 3.4046 + 2.12 × 10(-0.15158ctHb)
Equations for electrolyte parameters
Anion Gap, K+ equation 43
Anion Gap, K+ = cNa+ + cK+ - cCl– - cHCO3–
322
Anion Gap - equation 44
Anion Gap = cNa+ – cCl– – cHCO3–
cCa2+(7.4) - equation 45
Ref. [10]:
cCa2+(7.4) = cCa2+ × 10-0.24(7.4-pH)
Due to biological variations, this equation can only be used for a pH value in the range
7.2-7.6.
previous equation was an approximation of the current equation.
The change corresponds to 1 % in the pH range 7.2-7-6.
Equations 46 and 47
See Oxyhemoglobin dissociation curve (ODC).
mOsm - equation 48
Ref. [11]
mOsm = 2cNa+ + cGlu
Equations for oxygen parameters
pO2(T) - equation 14
Refs. [12,13]:
The standard Oxygen Dissociation Curve (ODC) is used (i.e. p50(st) = 3.578 kPa) at
actual values of pH, pCO2, FCOHb, FMetHb, FHbF (see Equations 46 and 47).
pO2(T) is calculated by a numerical method using:
ti(T) = ctHb × (1 - FCOHb - FMetHb) × sO2,i(T) + αO2(T) × pO2,i(T)
where
Equation Description See…
14.1 S = ODC(P,A,T ) Eq. 47
14.2 Eq. 46.12

S × (1 - FMetHb ) - FCOHb
sO2,i (T ) =
1 - FCOHb - FMetHb
14.3 P Eq. 46.10

pO2,i (T ) =
FCOHb
sO2,i (T ) × (1 - FCOHb - FMetHb )
14.4
é-1.15´10-2(T -37.0)+2.1´10-4 x(T -37.0)2 ù
aO2 =0.015eëê ûú
323
14.5 P is the variable during iteration.
14.6 ¶pH
A = ac -1.04 × × (T - 37.0 )
¶T
14.7 T = patient temperature in °C (keyed-in).
14.8 ¶pH
= -1.47 ´ 10-2 - 6.5 ´ 10-3 ´ (pH (37 ) - 7.40)
¶T
When ti(T) = ti(37.0), then pO2,i(T) = pO2(T)
Changes in the equations for pH(T) and ctO2 correspond to less than 0.5 % of pO2(T)
in the reference range for pH, pCO2, pO2 and ctHb and T in the interval 32-42 °C,
using FHbF = 0.5 %.
pO2(A) - equation 15
Ref. [3]:
pO2(A) = FO2(I) × (p(amb) – 6.275) – pCO2 × [RQ–1 - FO2(I) × (RQ–1 – 1)]
If FO2(I) and RQ are not keyed in, they are set to the default values.
The calculation requires that the sample type is entered as “Arterial” or “Capillary”.
pO2(A,T) - equation 16
Refs. [2,3,14]:
pO2(A,T) = FO2(I) × [p(amb) – pH2O(T)] – pCO2(T) × [RQ–1 - FO2(I) × (RQ–1 – 1)]

-2 ×(T – 37.0) – 9.6 × 10-5 × (T – 37.0)2]
pH2O(T) = 6.275 × 10[2.36 ×10
If FO2(I) and RQ are not keyed in, they are set to the default values.
pO2(a)/FO2(I) - equation 17
pO2 (a)
pO2 (a) / FO2 (I) =
FO2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and the
calculation requires that the sample type is entered as “Arterial” or “Capillary”.
pO2(a,T)/ FO2(I) - equation 18
pO2 (a, T )
pO2 (a, T ) / FO2 (I) =
FO2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and the
calculation requires that the sample type is entered as “Arterial” or “Capillary”.
p50 - equation 19
Refer to equation 46.10.
The ODC is determined as described in Equations 46 and 47.
324
P
p50 =
FCOHb
1+
0.5 ´ (1 - FCOHb - FMetHb )
Where
Description See...
P = ODC(S,A,T) Eq. 47
Eq. 46.11
0.5 ´ (1 - FCOHb - FMetHb ) + FCOHb
S=
1 - FMetHb
A=a
T = 37.0 °C Eq. 46.13
p50(T) - equation 20
P
p50(T ) =
FCOHb
1+
0.5 ´ (1 - FCOHb - FMetHb )
where
Description See…
P = ODC(S,A,T) Eq. 47
Eq. 46.11
0.5 ´ (1 - FCOHb - FMetHb ) + FCOHb
S=
1 - FMetHb
¶pH
A = a - 1.04 ´ ´ (T - 37.0 )
¶T
¶pH
= -1.47 ´ 10-2 - 6.5 ´ 10-3 ´ (pH (37 ) - 7.40)
¶T
T = patient temperature in °C (keyed-in)
p50(st) - equation 21
p50 is calculated for pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF = 0.
p50(st) = ODC(S,A,T)
Where
Description See…
S = 0.5 Eq. 46.11
325
Description See…
A = a6 corresponds to pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF Eq. 46.13
=0
T = 37.0 °C
pO2(A-a) - equation 22
pO2(A–a) = pO2(A) – pO2(a)
pO2(A-a,T) - equation 23
pO2(A-a,T) = pO2(A,T) – pO2(a,T)
pO2(a/A) - equation 24
pO2(a)
pO2(a/A)=
pO2(A)
pO2(a/A,T) - equation 25
pO2(a,T )
pO2(a/A,T )=
pO2(A,T )
pO2(x) or px - equation 26
Ref. [6]:
pO2(x) is calculated by a numerical method, with the use of these equations:

26.1 S = ODC(P,A,T) Eq. 47
26.2 S ´ (1 - FMetHb ) - FCOHb Eq. 46.12

sO2,i =
1 - FCOHb - FMetHb
26.3 P Eq. 46.10

pO2,i =
FCOHb
1+
sO2,i × (1 - FCOHb - FMetHb )
26.4 ti = ctHb × (1 – FCOHb – FMetHb) × sO2,i + 0.0105 × pO2,i
26.5 A=a
26.6 T = 37 °C
When ti = ctO2 - 2.3 mmol/L, then pO2,i = pO2(x), where ctO2 is determined as
described in equation 27.
326
pO2(x) cannot be calculated on the basis of a default ctHb value.
pO2(x) can only be calculated if the measured sO2(a) ≤0.97.
pO2(x,T) - equation 50
Ref. [6,14]
pO2(x) is calculated by a numerical method, with the use of these equations:
50.1 S = ODC(P,A,T) Eq. 47
50.2 Eq. 46.12

S × (1 - FMetHb ) - FCOHb
sO2,i (T ) =
1 - FCOHb - FMetHb
50.3 P Eq. 46.10

pO2,i (T ) =
FCOHb
1+
sO2,i (T ) ´ (1 - FCOHb - FMetHb)
50.4 ti(T ) = ctHb × (1 - FCOHb - FMetHb) × sO2,i(T ) + αO2(T ) × pO2,i(T )
50.5 ¶pH Eq. 20

A = a - 1.04 ´ ´ (T - 37.0 )
¶T
50.6 T = patient temperature
50.7 αO2(T ) = 0.0105e [-0.115 × (T - 37) + 21 × 10-5 × (T - 37)2]
50.8 pO2,i = pO2(x,T)
when ti(T) = ctO2(37 ° C) - 2.3 mmol/L
pO2(x,T) is calculated in accordance with OSA V3.0.
pO2(x,T) can only be calculated if the measured sO2(a) ≤0.97.
pO2(x,T) is tagged with ? if any of the following parameters: sO2, FMetHb, FCOHb, pO2,
pCO2, pH or ctHb is tagged with ?.
ctO2 - equation 27
Ref [3]:
ctO2 = αO2 ×pO2 + sO2 × (1 - FCOHb - FMetHb) × ctHb
αO2 is the concentrational solubility coefficient for O2 in blood (here set to 0.0105
mmol/L/kPa at 37 °C [5].
ctO2 cannot be calculated on the basis of a default ctHb value.

oxygen solubility coefficient is now changed from 0.00983 to 0.0105 to be in accord-
ance with NCCLS (CLSI)-approved guidelines [5].
The change corresponds to 0.00067 mmol/L/kPa.
327
ctO2(a-v̄) - equation 28
ctO2(a-v̄) = ctO2(a) - ctO2(v̄)
where ctO2(a) and ctO2(v̄) are calculated from equation 27 for arterial and mixed
venous blood, respectively. The calculation requires two measurements and input of
both pO2(v)̄ and sO2(v̄).
BO2 - equation 29
Ref. [15]:
BO2 = ctHb × (1 – FCOHb – FMetHb)
BO2 cannot be calculated on the basis of a default ctHb value.
ctO2(x) or cx - equation 30
Ref. [6]:
The ODC is determined, as described in Equations 46 and 47.
ctO2(x) = ctO2(a) – ti
where
30.1 ti = ctHb × (1 – FCOHb – FMetHb) × sO2,i + 0.0105 × pO2(5)
30.2 pO2(5) = 5.00 kPa
30.3 S = ODC(P,A,T) Eq. 47
30.4 Eq. 46.9

é FCOHb ù
P = pO2(5) ´ ê1 + ú
êë sO2,i ´ (1 - FCOHb - FMetHb)úû
30.5 S ´ (1 - FMetHb ) - FCOHb Eq. 46.12

sO2,i =
1 - FCOHb - FMetHb
30.6 A=a
30.7 T = 37.0 °C
ctO2(a) is determined as described in equation 27.
ctO2(x) cannot be calculated on the basis of a default ctHb value.
ctO2(x) can only be calculated if the measured sO2(a) <0.97.
ḊO2 - equation 31
ḊO2 = ctO2 × Qṫ
Q̇t is the cardiac output and is an input parameter for the calculation of ḊO2.
If Qṫ is not keyed in, ḊO2 will not be calculated.
328
Q̇t - equation 32
·
· V O2
Qt =
ctO2 ( a - v )
If V̇O2 is not keyed in, Q̇t will not be calculated.
V̇O2 - equation 33
V̇O2 = Q̇t × ctO2(a-v̄)
If Q̇t is not keyed in, V̇O2 will not be calculated.
FShunt - equation 34
Ref. [3]:
c tO2 (c) - c tO2 (a)

FShunt =
c tO2 (c) - c tO2 (v)
34.1
ctO2 (A) - ctO2 (a)
FShunt @
ctO2 (A) - ctO2 (v)
34.2
ctO2 (a) - ctO2 (v) ù
-1
é
FShunt = ê1 + ú
ëê ctO2 (A) - ctO2 (a) ûú
where:
ctO2(c): total oxygen in pulmonary capillary blood

ctO2(a): total oxygen in arterial blood
ctO2(A): total oxygen in alveolar air. Oxygen tension = pO2(A).
ctO2(v)̄ : total oxygen in mixed venous blood
34.3 ctO2(a) = 0.0105pO2(a) + ctHb x (1 – FCOHb – FMetHb) x sO2(a)
34.4 ctO2(A) = 0.0105pO2(A) + ctHb x (1 – FCOHb – FMetHb) x sO2(A)
329
34.5 ctO2(v̄) = 0.0105pO2(v̄) + ctHb × (1 - FCOHb - FMetHb) × sO2(v)̄
where:
pO2(a): oxygen tension in arterial blood; measured
pO2(A): oxygen tension in alveolar blood. See equation 15.
pO2(v̄): oxygen tension in mixed venous blood; measured and then entered
sO2(a): oxygen saturation in arterial blood; can be measured
sO2(A): oxygen saturation in (alveolar) blood calculated from equation 39 where P =

pO2(A)
sO2(v)̄ : oxygen saturation in mixed venous blood; measured and then entered
The calculation requires that the sample type is entered as “Arterial” or “Capillary”
If sO2(a) >0.97, the default value (3.578 kPa) will be used to estimate the ODC.
If no venous sample is measured, FShunt is estimated assuming:
ctO2(a) - ctO2(v̄) = 2.3 mmol/L in equation 34.2
FShunt(T) - equation 35
Refs. [3, 12]:
ctO2 (a,T ) - ctO2 (v,T ) ù

-1
é
FShunt(T ) = ê1 + ú
ëê c tO2 ( A,T ) - ctO2 (a,T ) ûú
where:
ctO2(a,T): total oxygen in arterial blood at patient temperature
ctO2(A,T): total oxygen in alveolar blood at patient temperature
ctO2(v,̄ T): total oxygen in mixed venous blood at patient temperature
35.1 ctO2(a,T) = ctO2 calculated from equation 25 for arterial pO2 and sO2 values at
37 oC
35.2 ctO2(A,T) = αO2(T) × pO2(A,T) + ctHb × (1 - FCOHb - FMetHb) × sO2(A,T)

-2 × (T - 37.0) + 2.1 × 10-4 × (T - 37.0)2]
35.3 αO2(T) = 0.0105e[ -1.15 × 10
35.4 pO2(A,T) is calculated from equation 16
35.5 sO2(A,T) = S
35.6 S = ODC(P,A,T)
See equation 47
35.7 P = pO2(A,T)
35.8 ¶pH
A = a - 1.04 ´ ´ (T - 37.0 )
¶T
35.9 T = patient temperature (keyed-in)
330
35.10 ¶pH
= -1.47 ´ 10-2 - 6.5 ´ 10-3 ´ (pH (37 ) - 7.40)
¶T
If sO2(a)>0.97, the default p50(st) (3.578 kPa) will be used to determine the ODC.
35.11 ctO2(v,̄ T) = ctO2(v̄) at 37 oC is calculated from equation 27 for mixed venous blood
values of pO2 and sO2.
If no mixed venous sample is measured, the FShunt(T) is estimated assuming

ctO2(a,T) - ctO2(v̄,T) = 2.3 mmol/L in equation 35.
RI - equation 36
pO2 (A) - pO2 (a)

RI =
pO2 (a)
RI(T) - equation 37
pO2 (A,T ) - pO2 (a,T )

RI(T ) =
pO2 (a,T )
Qx - equation 38
Ref. [6]:
2.3
Qx =
ctO2 (a) - ti
38.1 ti = ctHb × (1-FCOHb-FMetHb) × sO2,i + 0.0105pO2(5)
38.2 pO2(5) = 5.00 kPa
38.3 S = ODC(P,A,T)
38.4 Eq. 46.9

é FCOHb ù
P = pO2(5) ´ ê1 + ú
ëê s O2,i ´ (1 - F COHb - F MetHb)ûú
38.5 Eq. 46.12

S ´ (1 - FMetHb ) - FCOHb
sO2,i =
1 - FCOHb - FMetHb
38.6 A=a
38.7 T = 37.0 °C
ctO2(a) is determined as described in equation 27
Qx cannot be calculated on the basis of a default ctHb value
331
Qx can only be calculated if the measured sO2(a) <0.97
The calculation requires that the sample type is entered as “Arterial” or “Capillary”
V(B) - equation 42
Ref. [3]:
V ( CO )
V (B ) =
24 ´ ( FCOHb (2 ) - FCOHb (1) ) ´ 0.91 ´ ctHb
42.1
V (CO )
V (B ) =
21.84 ´ ( FCOHb (2 ) - FCOHb (1) ) ´ ctHb
42.2 V(CO) = volume (in mL) of carbon monoxide injected according to the procedure
and the value keyed in
42.3 FCOHb(1) = fraction of COHb measured before the CO injection
42.4 FCOHb(2) = fraction of COHb measured after the CO injection
VCO2/V(dry air) - equation 51
pCO2
VCO2 / V (dry air) =
p ( amb ) - 6.275
VO2/V(dry air) - equation 52
pO2
VO2 / V (dry air) =
p ( amb ) - 6.275
Equations for oximetry parameters
FHHb - equation 41
FHHb = 1 - sO2 x (1 - FCOHb - FMetHb) - FCOHb - FMetHb
If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default values.
FO2Hb - equation 40
FO2Hb = sO2 x (1 - FCOHb - FMetHb)
If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default values.
sO2 - equation 39
The ODC is determined as described in Equations 46 and 47 (points I and III).
332
S ´ (1 - FMetHb ) - FCOHb
sO2 =
1 - FCOHb - FMetHb
Where
Description See…
S = ODC(P,A,T)
pO2 ´ FCOHb Eq. 46.9

P = pO2 +
sO2 ´ (1 - FCOHb - FMetHb )
A=a
T = 37.0 °C
Hct - equation 13
Ref. [15]:
Hct = 0.04939 × ctHb
Hct cannot be calculated on the basis of a default ctHb value.
previous equation Hct = 0.0485 × ctHb + 8.3 × 10-3 was changed to ensure that
Hct = 0 when ctHb = 0. The slope was adjusted to make Hct identical for the two
equations when ctHb = 9.3087 mmol/L.
The change corresponds to 1 % in the ctHb range 6.3-12.3.
FHbF - equation 49
An iterative method is used to calculate FHbF. The input parameters are sO2, ceHb
(effective hemoglobin concentration) and cO2HbF (concentration of fetal oxyhemo-
globin).
In the calculations the following are assumed: pH = 7.4, pCO2 = 5.33 kPa, FCOHb = 0,
FMetHb = 0, cDPG = 5 mmol/L, and temp = 37 °C.
49.1 An estimate of FHbF is made: FHbFest = 0.8
49.2 pO2,est = ODC (sO2,A,T); Eq. 47
where the constant A depends on FHbF = FHbFest
49.3 sO2 (for fetal blood) = ODC (pO2,est A,T); Eq. 47
where FHbF = 1
49.4 cO2HbFest = sO2 (fetal blood) × ceHb ×FHbFest
49.5 cO2HbFmeas. - cO2HbFest

DFHbFest =
ceHb
49.6 If |ΔFHbFest| ≥ 0.001, proceed to equation 49.7.
If |ΔFHbFest| < 0.001, proceed to equation 49.9.
333
49.7 FHbFest,new = FHbFest,old + ΔFHbFest
49.8 Return to equation 49.2.
49.9 End of iteration. The value for FHbF has converged.
Related information
Calculation of the values of the oximetry parameters, page 367
Converting results to other units
You can use the equations in the table to convert results to other units.
Parameter Unit Equation to convert
Temperature (T) T ºF = 9/5 (T ºC) + 32
T ºC = 5/9 (T ºF – 32)
cK+, cNa+, cCl– cX (meq/L) = cX (mmol/L) where X is K+, Na+ or Cl–
cCa2+ cCa2+ (meq/L) = 2 x cCa2+ (mmol/L)
cCa2+ (mg/dL) = 4.008 × cCa2+ (mmol/L)
cCa2+ (mmol/L) = 0.5 x cCa2+ (meq/L)
cCa2+ (mmol/L) = 0.2495 × cCa2+ (mg/dL)
Pressure p (mmHg) = p (Torr) = 7.500638 x p (kPa)
p (kPa) = 0.133322 × p (mmHg) = 0.133322 x p (Torr)
ctHb* ctHb (g/dL) = 1.61140 × ctHb (mmol/L)
ctHb (g/L) = 16.1140 × ctHb (mmol/L)
ctHb (mmol/L) = 0.62058 × ctHb (g/dL)
ctHb (mmol/L) = 0.062058 × ctHb (g/L)
ctCO2, ctO2, ctO2(a-v)̄ , BO2 Vol % = 2.241 × (mmol/L)
Vol % = mL/dL
mmol/L = 0.4462 × (mL/dL)
V̇O2 V̇O2 mmol/min = V̇O /22.41 mL/min

2
cGlu*** cGlu (mg/dL) = 18.016 × cGlu (mmol/L)
cGlu (mmol/L) 0.055506 × cGlu (mg/dL)
cLac**/*** cLac (mg/dL) = 9.008 × cLac (mmol/L)
cLac (mmol/L) = 0.11101 × cLac (mg/dL)
cLac (meq/L) = cLac (mmol/L)
cCrea***** cCrea (µmol/L) = 88.4 xcCrea (mg/dL)
cCrea (mg/dL) = 0.011312 xcCrea (µmol/L)
334
Parameter Unit Equation to convert
ctBil**** ctBil (μmol/L) = 17.1 × ctBil (mg/dL)
ctBil (μmol/L) = 1.71 × ctBil (mg/L)
ctBil (mg/dL) = 0.0585 × ctBil (μmol/L)
ctBil (mg/L) = 0.585 × ctBil (μmol/L)
* See [2].
** cLac conversion is based on the molecular weight of lactic acid.
*** See [16].
**** Bilirubin can only be measured on neonatal samples. This parameter is only avail-
***** Available with software featuring Creatinine and Urea.
Oxyhemoglobin dissociation curve
ODC equations
These equations account for the effect of FCOHb on the shape of the Oxyhemoglobin
Dissociation Curve (ODC) in accordance with the Haldane equation.
Equation 46 - Ref. [12,14]:
y - y0 = (x - x0) + h × tanh[k0(x - x0)]
where k0 = 0.5343
46.1 x = ln p
46.2 s
y = ln
1- s
46.3 so
yo = ln
1 - so
where s0 = 0.867
46.4 x0 = x00 + a + b = ln(p00) + a + b
where p00 = 7 kPa.
The actual position of the ODC in the coordinate system (ln(s/(1-s)) vs ln(p)) used in
the mathematical model, is expressed by equations 46.3 and 46.4.
The symbols a and b reflect the ODC displacement from the reference position to its
actual position in this coordinate system:
a describes the displacement at 37 °C.
b the additional displacement due to the patient temperature difference from 37 °C.
335
The ODC reference position
The reference position of the ODC was chosen to be the one that corresponds to the
default value for p50(st) = 3.578 kPa, which is traditionally considered the most likely
value of p50 for adult humans under standard conditions, namely:
pH = 7.40; pCO2 = 5.33 kPa; FCOHb, FMetHb, FHbF = 0; cDPG = 5 mmol/L.
The ODC displacement
The ODC displacement which is described by a and b in the coordinate system

(ln(s/(1-s)) vs ln(p)), is given by the change in p50 from the default to its actual value
in a more common coordinate system (sO2, pO2).
46.5 p
x - xo = ln -a-b
7
46.6 h = h0 + a, where h0 = 3.5
46.7 b = 0.055 × (T - To)
T o = 37 °C
46.8 p = pO2 + M × pCO where M × pCO is taken from the Haldane equation [17]:
pO2 pCO
=M´
cO2Hb cCOHb to give equation 46.9
46.9 pO2 é FCOHb ù

p = pO2 + ´
sO2 êë1 - FCOHb - FMetHb úû or equation 46.10
46.10 p
pO2 =
FCOHb
1+
sO2 ´ (1 - FCOHb - FMetHb )
s The ordinate, s, may loosely be termed the combined

oxygen/carbon monoxide saturation of hemoglobin and is
described by equation 46.11.
1
~a 1 = Reference position
2= Actual position
2
46.11 cO2Hb + cCOHb

s=
cO2Hb + cCOHb + cHHb
sO2 ´ (1 - FCOHb - FMetHb ) + FCOHb
s=
or 1 - FMetHb
46.12
s ´ (1 - FMetHb ) - FCOHb
sO2 =
1 - FCOHb - FMetHb
336
The actual ODC position
The actual position of the ODC at 37 °C for a given sample is, in principle, determined
in two steps:
1. The calculation of the combined effect on the ODC position at 37 °C of all known
causes for displacement (= ac in equation 46.13), and based on this position.
2. The computation by a numerical method of the actual position of the ODC curve by
shifting it to pass through the known set of coordinates (P0, S0).
46.13 a = ac + a6
46.14 ac = a1 + a2 + a3 + a4 + a5
46.15 a1 = -0.88 × (pH - 7.40)
46.16 pCO2
a2 = 0.048 ´ ln
5.33
46.17 a3 = -0.7 × FMetHb
46.18 a4 = (0.06 - 0.02FHbF) × (cDPG - 5)
46.19 a5 = -0.25 × FHbF
337
To determine the actual displacement

1. pO2, sO2 can be used. If sO 2>0.97, the calculation is based on the calculation in
steps 2 or 3.
s ~ ac
1
✳(P01 S0)
1 = Reference position
Coordinates (P0, S0) are calculated from equations 46.9 and 46.11. If FCOHb and
FMetHb are not known, the default values are used.
The ODC is shifted from the reference position to a position that corresponds to
the effect of all measured parameters according to step 1. The magnitude of the
shift is ac. The ODC is then further shifted to pass through the point P0, S0). The
magnitude of the shift is a6.
s ~ ac
1 ~ a6
✳(P01 S0)
2. sO2>0.97 (or erroneous) and p50(st) is known. Coordinates (P0, S0) are calculated
from (p50(st), 0.5) with the use of equations 46.9 and 46.11. Reference position
of the ODC.
The ODC is shifted from the reference position to pass through the point (P0, S0).
In this position, the ODC reflects the p50(st) of the patient, i.e., the particular
patient but at standard conditions.
1
✳(P01 S0)
338
The ODC is further shifted, as determined by the effect of the measured parame-
ters (ac), to its actual position. This position reflects the p50(act) of the patient.
1 ~ a6
✳ (P01 S0)
3. sO2> 0.97 (or erroneous). Reference position of the ODC.
The position of the actual ODC can now be approximated from the reference posi-
tion, using the actual values of pH, pCO2, FCOHb, FMetHb and FHbF to determine
the shift ac.
1
~ ac
Note: The curves are used only to illustrate the principles of the ODC determina-
tion.
Coordinates on the ODC
Calculation of a set of coordinates on the ODC is symbolized by:
Equation 47:
S = ODC(P,A,T) or P = ODC(S,A,T)
These equations are symbolic representations of the relationship between saturation

(S), tension (P), displacement (A) and temperature (T).
To calculate S or P and to further calculate sO2 and pO2, the other variables should be
specified. S and P are calculated using numerical methods.
P is input to equation 46.1.
339
S is input to equation 46.2.
A is input to equation 46.5.
T is input to equation 46.7.
References
1. Wandrup JH. Physicochemical logic and simple symbol terminology of oxygen

status. Blood Gas News 1993; 2,1: 9-11.
2. Siggaard-Andersen O. The acid-base status of the blood. 4th revised ed. Copen-
hagen: Munksgaard, 1976.
3. Siggaard-Andersen O, Wimberley PD, Fogh-Andersen N, Gøthgen IH. Measured
and derived quantities with modern pH and blood gas equipment: calculation algo-
rithms with 54 equations. Scand J Clin Lab Invest 1988; 48, Suppl 189: 7-15.
4. Burnett RW, Noonan DC. Calculations and correction factors used in determination
of blood pH and blood gases. Clin Chem 1974; 20,12: 1499-1506.
5. Blood gas and pH analysis and related measurements; approved guideline. NCCLS
(CLSI) document C46-A2, Vol. 29 No. 8, 2009.
6. Siggaard-Andersen O, Gøthgen IH, Wimberley PD, Fogh-Andersen N. The oxygen
status of the arterial blood revised: relevant oxygen parameters for monitoring the
arterial oxygen availability. Scand J Clin Lab Invest 1990; 50, Suppl 203: 17-28.
Available as AS108.
7. Wandrup JH. Oxygen uptake in the lungs. Blood Gas News 1992; 1,1: 3-5.
8. Severinghaus JW. Blood gas calculator. J Appl Physiol 1966; 21,3: 1108-16. Avail-
able as ST36.
9. Christiansen TF. An algorithm for calculating the concentration of the base excess
of blood. In: Siggaard-Andersen O, ed. Proceedings of the IFCC expert panel on pH
and blood gases held at Herlev Hospital 1980. Copenhagen: Radiometer Medical
A/S, 1981: 77-81.
10. Siggaard-Andersen O, Thode J, Wandrup JH. The concentration of free calcium ions
in the blood plasma ionized calcium. In: Siggaard-Andersen O, ed. Proceedings of
the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980. Copen-
hagen: Radiometer Medical A/S, 1981: 163-90. Available as AS79.
11. Burton DR. Clinical physiology of acid-base and electrolyte disorders. 4th ed. New
York: McGraw-Hill, 1994.
12. Siggaard-Andersen O, Wimberley PD, Gøthgen IH, Siggaard-Andersen M. A mathe-
matical model of the hemoglobin-oxygen dissociation curve of human blood and of
the oxygen partial pressure as a function of temperature. Clin Chem 1984; 30:
1646-51.
13. Siggaard-Andersen O, Wimberley PD, Gøthgen IH, Fogh-Andersen N, Rasmussen
JP. Variability of the temperature coefficients for pH, pCO2 and pO2 in blood.
Scand J Clin Lab Invest 1988; 48, Suppl 189: 85-88.
14. Siggaard-Andersen O, Siggaard-Andersen M. The oxygen status algorithm: a
computer program for calculating and displaying pH and blood gas data. Scand J
Clin Lab Invest 1990; 50, Suppl 203: 29-45.
15. Kokholm G. Simultaneous measurements of blood pH, pCO2, pO2 and concentra-
tions of hemoglobin and its derivatives - a multicenter study. Scand J Clin Lab
Invest 1990; 50, Suppl 203: 75-86. Available as AS107.
16. Olesen H et al. A proposal for an IUPAC/IFCC recommendation, quantities and
units in clinical laboratory sciences. IUPAC/IFCC Stage 1, Draft 1, 1990: 1-361.
17. Roughton FJW, Darling RC. The effect of carbon monoxide on the oxyhemoglobin
dissociation curve. Am J Physiol 1944; 141: 17-31.
340
Principles of operation 12
General construction
Sensors
In this manual, the term sensor refers to an individual sensor as part of the sensing
array within a Sensor Cassette. The electrical signal from each sensor is measured by
proprietary analog electronics contained within the analyzer unit.
The sensors are located on sensor boards in the Sensor Cassette.
Ref K Na P CO2 pH Cl Ca P O2
Lac Glu
General measurement principles
Introduction
There are four different measuring principles employed in the sensors in the ABL90
FLEX analyzer.
• Potentiometry: The potential of an electrode chain is measured by a voltmeter,

and related to the concentration of the sample (the Nernst equation). The potentio-
metric measuring principle is applied in the pH, pCO2, K+, Na+, Ca2+ and Cl-
sensors.
• Amperometry: The magnitude of an electrical current that flows through an elec-
trode chain is proportional to the concentration of the substance that is oxidized or
reduced at a electrode in the chain. The amperometric measuring principle is
applied in the cGlu and cLac sensors.
• Optical pO2: The optical system for pO2 is based on the ability of O2 to reduce the
intensity and time constant of the phosphorescence from a phosphorescent dye that
is in contact with the sample. This measuring principle is applied in the pO2 sensor.
• Spectrophotometry: Light passes through a cuvette that contains a hemolyzed
blood sample. The absorption spectrum is used to calculate oximetry parameters.
This measuring principle is used for ctHb, sO2, FO2Hb, FCOHb, FHHb, FMetHb and
FHbF and ctBil*.
341
Chapter 12: Principles of operation ABL90 FLEX: Instructions for use
Activity vs. concentration
Strictly speaking, in potentiometry the potential of an electrode chain is related to the

activity of a substance not its concentration.
The activity of a substance can be considered the effective concentration of a species

that takes non-ideality of the medium into account.
Activity and concentration are related by this equation:
ax = ɣcx
where:
ax = the activity of the species x
ɣ = the activity coefficient of species x under the measurement conditions (for ideal
systems ɣ = 1)
cx = the concentration of species x (mol/L)
Note: To be exact, activity is related to the molality of species x (the amount of

substance of the solute (in mol), divided by the mass of the solvent (in kg)). However,
molality is converted to concentration (molarity).
The analyzer automatically converts activities into concentrations. The term concentra-
tion is therefore used in explanations of the measuring principles for each of the
sensors.
Fluid transport system
Patient samples and solutions necessary for calibration, QC measurements and other
procedures are transported through the fluid transport system of the analyzer. The
diagram shows the fluid transport system. The sample is aspirated from the inlet,
transported through the Sensor Cassette and the oximetry module and into the waste
pouch of the Solution Pack.
After a patient sample analysis the system is rinsed. The CAL 1 solution from the Solu-
tion Pack is used.
342
ABL90 FLEX: Instructions for use Chapter 12: Principles of operation
1 Liquid sensor 3 15 Flow selector (to select a solu-

tion/gas)
2 Hemolyzer 16 Closed position (nothing selected)
3 Oximetry valve 17 Position to select air
4 Liquid sensor 2 18 Pouch not in use
5 Reference electrode 19 Pouch to hold waste
6 Sensor Cassette 20 Pouch with CAL 3 solution
7 Optical pO2 sensor 21 Pouch to hold clot waste
8 Liquid sensor 1 22 Pouch with CAL 1 solution
9 Sample inlet (position for capillary 23 Pouch with gas mixture

tubes)
10 Sample inlet (position for syringes 24 Pouch with QC 1 solution

and test tubes)
11 Peristaltic pump 25 Pouch with CAL 2 solution
12 Waste valve 26 Pouch with QC 3 solution
13 Smart chip 27 Pouch with QC 2 solution
14 Solution Pack 28 Electrical shield
343
Measurement process
The measurement process is similar for all types of measurement, patient sample anal-
ysis, built-in QC measurements, ampoule-based QC measurements, calibration-verifi-
cation measurements and calibration measurements.
1. The sample (patient sample, QC solution or calibration solution) is aspirated or

drawn into the sensor measurement chamber and the oximetry measurement
chamber.
2. Measurements are done as soon as the sample is in the chambers. Liquid sensors
control the process and can detect sample inhomogeneity and air bubbles in the
sample. If any problems are found or the sample volume is too low, the measure-
ment is aborted and the problem reported in a message attached to the result.
3. A rinse is done.
4. A status calibration is done for all parameters.
Rinse process
A rinse is done after a measurement is completed.
1. The sample is removed.

2. The system is rinsed with a mixture of solution and air/gas.
3. The system is filled with CAL1 to prepare for next sample.
During the rinse procedure, a check of the fluid transport system is done.
Calibration
Definition
Calibration is the process that relates the sensor signals during the calibration
sequence to the values of the calibrating solutions and air. Calibration enables the
sensor signals to be converted to the accurate values for an unknown sample.
Frequency
Automatic calibrations are scheduled by default to be done at regular intervals. This is

necessary to compensate for small changes in the behavior of the sensors in the
Sensor Cassette.
Calibration solutions
CAL 1, CAL 2 and CAL 3 solutions are used for the calibration of sensors. Air is used for
the calibration of the pO2 sensor.
The calibration solutions contain known concentrations of the parameters to be meas-

ured. These concentrations are necessary to determine the measurement results. The
concentrations are automatically read from a chip on the Solution Pack when the Solu-
tion Pack is installed.
344
The calibration equation
About the calibration equation
The calibration equation expresses the relationship between the electrical measure-
ment at a sensor and the concentration of the parameter specific to the sensor.
Plotting a calibration line
The calibration equation for each sensor is established during sensor calibration.
For the pH sensor, the relationship between potential and pH is linear. Thus, this type
of sensor can be calibrated from the measurement of two solutions of known concen-
tration. The measured potentials are plotted against the known concentrations and a
line is drawn between them.
The calibration of the pH sensor shows how this equation is established.
• Solution 1 (s1), which has a pH of 7.40, gives a measured potential of 2.3 mV.
• Solution 2 (s2), which has a pH of 7.03, gives a measured potential of 20.4 mV.
These points are plotted on a graph and a line is drawn between them.
mV
20.4
2.3
pH
7.03 7.40
s2 s1
The calibration line is used to convert the potential measured at the pH sensor during
sample analysis to an actual pH value.
For electrolyte sensors, ion concentrations are plotted on a log scale (log10(aion)).
Sensitivity, status and drift
Sensitivity
The sensitivity value shown in calibration results shows how much the sensitivity of a
sensor differs from the sensitivity of a theoretical sensor.
The sensitivity of a theoretical sensor is 100 %. If a sensor sensitivity is reported to be

95 %, its sensitivity is 5 % less than the theoretical sensor sensitivity.
The sensitivity of a sensor is the slope of its calibration line.
345
mV
96
65.25 2
pH
6.8 7.3
1 Calibration line for the sensor 2 Calibration line for a theoretical

sensor
Slope = –58.4 mV/pH
Slope= –61.5 mV/pH
Sensitivity = 95 %
Sensitivity = 100 %
The sensitivity of a sensor is calculated as:
Potential at 6.8 - Potential at 7.3

Sensitivity = (%)
61.5 ´ (7.3 - 6.8 )
Where 61.5 = sensitivity of theoretical sensor.
Each sensor has its own sensitivity limits.
The sensitivities are range checked:
pH pCO2 pO2 cK+ cNa+ cCa2+ cCl- cGlu cLac
% % % % % % % pA/mmol/L pA/mmol/L
Min. 85 60 85 85 85 85 75 100 100
Max. 105 105 110 105 105 105 105 2000 2000
The calibration line slope is re-established with every calibration.
A blood sample gives a measured potential of 4.8 mV at the pH sensor. This potential
corresponds to a pH of 7.35 (see the diagram).
346
mV
20.4
4.8
2.3
pH
7.03 7.35 7.40
s2 s1
To compensate for deviations from ideal conditions (for example, residual rinse solution
that dilutes a sample), a correction is applied to measurement results. Applied correc-
tions are usually linear corrections.
Status
The calibration status values are, in general, defined as the sensor signals of CAL 1
except for pO2, which is only calibrated in one point (pO2 status reflects the cal check).
Drift
Drift describes the variation in location of the calibration line between consecutive cali-
brations. A Status calibration is done with every measurement. This lets the analyzer
automatically compensate for status drifts. Sensitivity drift is usually insignificant in
comparison with status drift.
Reference electrode
Background information - reference electrode
Purpose
The purpose of the reference electrode is to provide a stable, fixed potential, against
which the potential differences can be measured.
The potential of the reference electrode is not changed by the sample composition.
Fixed potential
A fixed potential is maintained at the reference electrode by these equilibrium reac-

tions:
AgCl Û Ag+ + Cl-

Ag+ + e- Û Ag
347
These reactions are possible because the electrode is made of an Ag rod coated with
AgCl to provide the Ag/Ag+ equlibrium in a solution with constant Cl- concentration and
thus determining the reference potential.
Use
The reference electrode is used in the measurement of pH and electrolyte concentra-

tions. Contact with the sample is made via a membrane junction between the refer-
ence electrode liquid chamber and the measuring chamber.
Construction - reference electrode
Construction
3
5
2
1 Membrane – Interface to the 4 Electrical contact – The point of

sample electrical contact between the elec-
trode and the analyzer
2 Electrolyte solution – Acts as a 5 Housing – Sensor Cassette housing

salt-bridge solution that maintains with integrated reference electrode
an electrical contact between the
electrode and the sample
3 Electrode – Provides the contact

between the electrolyte solution
and the electrical contact
pH and electrolyte sensors
Construction - pH and electrolyte sensors
Construction
The pH and electrolyte sensors are of solid-state design with a H+, K+, Na+ and Ca2+
sensitive PVC membrane. The Cl– sensor is of solid-state design with a Cl– sensitive
epoxy membrane.
The pH sensor is used as an example:
348
1
2
3
4
1 Membrane – Ion-selective 3 Electrical contact – The point of

membrane that is in direct contact electrical contact between the
with the sample or calibration solu- sensor and the analyzer
tion and that is sensitive to a
specific ion, e.g. the H+ ions
2 Solid-state contact – The point of 4 Sensor base – The structural plat-

electrical and ionic contact with the form on which the sensor is formed
membrane
Measurement principles - pH and electrolyte sensors
Potentiometric measurement principle
The pH and electrolyte sensors are measured according to the potentiometric measure-
ment principle, where the potential of an electrode chain recorded at a voltmeter is
related to the concentration of a substance via the Nernst equation.
Electrode chain
The electrode chain (or electrical circuit) set up to measure pH/electrolytes is shown in
this diagram:
1
V
2 3 4 5 6
1 Voltmeter – measures the potential 4 Sample – the unknown liquid that

in the circuit. is measured.
2 Reference electrode – provides 5 Membrane – an ion-sensitive

electrical connection to the volt- membrane, which is sensitive to
meter. H+/electrolyte ions.
3 Liquid junction – point of contact 6 Solid-state contact – provides elec-

between the reference electrode trical connection to the voltmeter.
and the sample.
349
Electrode chain potential
Every element in the electrode chain contributes a voltage to the total potential drop
through the chain.
The total potential across the electrode chain, therefore, is the sum of these separate
potentials, all but one of which are known and constant, as outlined in the table:
Element Potential Symbol
Reference electrode Known and constant when the Ag/AgCl is Eref

immersed in the electrolyte solution
Liquid junction between the electrolyte Known and constant. Independent of ELJ
solution in the reference electrode and the sample composition .
sample
Ion-sensitive membrane that separates Unknown. Dependent on sample composi- ESample

the sample and the pH sensor tion.
Solid-state contact Known and constant EE
Total potential Measured by the voltmeter Etot
Unknown potential
The unknown potential difference across the ion-sensitive PVC membrane is the differ-
ence between the measured total potential and the sum of the known potentials:
Esample = Etotal - (Eref + ELJ + EE)
Ion-sensitive membrane
The potential difference across the membrane arises as a consequence of a change in

the charge balance at the membrane.
The membrane is sensitive to H+/electrolyte ions in that it has an ion-exchange ability.

The internal solid-state reference electrode maintains the internal potential at the same
level. Changes in the H+/electrolyte ions of the sample cause measurable changes in
the overall potential.
Nernst equation
The potential difference across the membrane in the sensor can be expressed by the
Nernst equation:
RT
Esample=E0 + ´ ln ax
nF
Where:
ESample = Potential between the reference electrode and the ion-sensitive membrane
E0 = Reference electrode potential
R = Gas constant (8.3143 J/°K-mole)
T = Absolute temperature (°K)
n = Charge on the ion
F = Faraday constant (96487 C/mole)
ax = Activity of the species x
350
Activity and concentration
The Nernst equation lets you calculate the activity of known concentrations of samples
(pH and electrolytes).
The measured activities are used to calculate the concentrations by the use of the cali-
bration results of the analyzer.
Calibration - pH and electrolyte sensors
Calibrations of pH and electrolyte sensors
The sensitivity calibration of the pH and electrolyte sensors gives the slopes of the cali-
bration lines. Status calibrations are done with every measurement to compensate for
small variations in sensor performance between calibrations.
Related information
Details about calibration frequency, page 175
Calculation of pH and electrolytes sensitivity
The sensitivity is calculated as follows:
pH sensor sensitivity:
mVcal2 -mVcal1
S=
-61.5mV× (pHcal2 -pHcal1 )
Electrolyte sensor sensitivity:
n (mVcal2 -mVcal1 )
S=
æc ö
61.5mV×log10 ç cal2 ÷
è c cal1 ø
Where:
• S is the sensitivity
• mVcal1 and mVcal2 are the signals measured by the sensor and when CAL1 and CAL2
solutions are used
• ccal1 and ccal2 are the concentrations of the electrolyte in the CAL1 and CAL2 solu-
tions
• n is the ionic charge
Status is defined as the sensor signal when CAL 1 solution is used.
Measurement - pH and electrolyte sensors
Calculation of pH and electrolyte values
The pH value measured from the sample is calculated as follows, from the sensor
signal of the sample mVsample:
351
mVsample -mVcal1
pH=pHcal1=
-61.5mV×S
The electrolyte concentration in a sample is calculated from this equation:
(
n Esample -Ecal1 )
c = c cal1×10 61.5mV×S
where n is the ionic charge. The measured value is applied a linear correction:
cdisplayed = k1 × c + k2
Note: cCl- is compensated for cHCO3- interference by the use of the measured pH and
pCO2, before the linear correction is applied.
Sensor response stability
The sensor response stability is the standard deviation of the last 5 calculated status
calibration values.
pCO2 sensor
Construction - pCO2 sensor
Construction
1 2
3
4
6 5
1 Silicone membrane – A membrane 5 Solid-state contact for the pH

that separates the sample and the system. The point of electrical
electrolyte solution. Is only perme- contact between the pH membrane
able to CO2 and H2O and the analyzer.
2 Electrolyte solution – A bicarbonate 6 Electrical contact between the

buffer that changes pH upon reference electrode and the
absorption/desorption of CO2 from analyzer
the sample
3 pH membrane – H+ sensitive 7 Sensor base – The structural plat-

membrane form on which the sensor is formed
4 Reference electrode – Ag/AgCl

electrode
352
Measurement principle - pCO2 sensor
Electrode chain
The electrode chain (or electrical circuit) set up to measure pCO2 is shown in the
diagram:
1
V
2 3 4
1 Voltmeter – Measures the voltage 3 Electrolyte solution – Medium for

potential in the circuit connection
2 pH electrode – Provides electrical 4 Internal reference electrode

connection to the voltmeter (Ag/AgCl) – Provides electrical
connection to the voltmeter
Electrode chain potential
The potential differences at all the junctions in the electrode chain are known and
constant, except that at the pH-sensitive membrane. (See the section pH and electro-
lyte sensors for a full explanation.)
The potential difference at the pH-sensitive membrane depends on the pH of the elec-
trolyte solution, which in turn depends on the CO2 content of the sample. This is
explained in the Measuring process topic.
Measurement process in the pCO2 sensor
This is an account of the measurement process in the pCO2 sensor.
Part Function
Transport of CO2 CO2 from the sample permeates the membrane
Dissolution of The CO2 dissolves in the electrolyte solution. This produces carbonic acid:
CO2
H2O + CO2 ⇔ H2CO3
Dissociation of Carbonic acid dissociates according to the this equilibrium reaction:

carbonic acid
H2CO3 ⇔ H+ + HCO3-
pH change The release of H+ ions changes the H+ concentration, and thus the pH of the
inner buffer solution on one side of the pH-sensitive membrane
Measurement of The concentration gradient of H+ ions across the membrane creates a poten-
potential tial difference across the membrane.
This change in potential across the membrane is measured by the voltmeter.
353
Part Function
Relation of pH The pH value is related to the partial pressure of CO2 in the sample by this
to pCO2 equation:
éHCO3- ùû
pH = pK a + log ë
a×pCO2
Where: pKa = -log Ka , the equilibrium constant for the dissociation of

carbonic acid in water
α = solubility coefficient for CO2 in water
The structure of the pCO2 sensor is similar to the pH sensor, including the
presence of a pH-sensitive membrane. The major difference is in the internal
electrolyte solution present in the pCO2 sensor which allows the dissolution of
CO2 and ultimate dissociation of carbonic acid mentioned above. If [cHCO3-]
and α in the electrolyte solution are constant, it results in this equation: pH =
K - log pCO2
Where K contains the equilibrium constant pKa , the solubility coefficient α and
the concentration of bicarbonate [cHCO3 -].
E = E'0 - 61.5 × pH = E0 + 61.5 × log pCO2.
Calibration - pCO2 sensor
Calibrations of the pCO2 sensor
The sensitivity calibration of the pCO2 sensor gives the slope of the calibration line.
Status calibrations are done with every measurement to compensate for small varia-
tions in sensor performance between calibrations.
Calibration levels
The ABL90 FLEX analyzer is equipped with a Solution Pack. This pack contains preci-
sion-tonometered fluids. The tonometry calibration gas mixture is of a known composi-
tion.
The partial pressure of CO2 (pCO2) and the solution pH values are known and
contained in the Solution Pack smart chip.
Calculation of pCO2 sensitivity
The sensitivity is calculated as follows:
mVcal2 -mVcal1
S=
æ pCO2 (cal2) ö
61.5mV×log10 ç ÷
è pCO2 (cal1) ø
Where
• S is the sensitivity
• mVcal1 and mVcal2 are the signals measured by the sensor when CAL1 and CAL2
solutions are used
• pCO2(cal1) and pCO2(cal2) are the concentrations of pCO2 in the CAL1 and CAL2
solutions
354
Status is defined as the sensor signal when CAL 1 solution is used.
Measurement - pCO2 sensor
Calculation of pCO2 values
The pCO2 value measured from the sample is calculated as follows, from the sensor
signal of the sample mVsample:
Esample -Ecal1
pCO2 = pCO2 (cal1)×10 61.5mV×S
The measured value is applied as a linear correction:
Sensor response stability
The sensor response stability is the standard deviation of the last 5 calculated status
calibration values.
pO2 sensor
Measurement principle - pO2 sensor
Optical system for pO2
The optical system for pO2 is based on the ability of O2 to reduce the intensity and
time constant of the phosphorescence from a phosphorescent dye that is in contact
with the sample.
The optical system for pO2 is shown in the diagram:
355
1
4
3 7
1 Dichroic mirror 5 Phosphorescence
2 Photodetector 6 Sample
3 Green LED 7 Excitation light
4 pO2 sensor
Measurement sequence
The green LED emits light, which is reflected by a dichroic mirror onto the pO2 sensor.
Due to the phosphorescence, red light is emitted back through the dichroic mirror and
onto a photo detector. The photo detector sends the electrical signals, proportional to
the light intensity, to the analog/digital converter and the data processing unit that
calculates the pO2 concentration.
Calculations
The pO2 is calculated on the basis of the Stern-Volmer equation, which describes the
relationship between the phosphorescence intensity/time constant (τ) and the pO2
value in a sample:
æt ö
pO2 (t ) =k× ç 0 -1 ÷
èt ø
Where k and τ0 are constants.
Calibration - pO2 sensor
Overview of pO2 calibrations
CAL 1 solution and ambient air are used to do a sensitivity calibration of the pO2
sensor. A status calibration is done before every measurement to check the perform-
ance of the sensor between sensitivity calibrations.
Sensitivity
The sensitivity is defined as the percentage of the measured pO2 on ambient air
compared to the reference value:
356
pO2 (meas )
S=
pO2 (ref )
Where pO2(ref) is the pO2 tension in ambient air saturated with water vapor:
pO2(ref) = FO2 · (p(amb) - pH2O)
where FO2 is the pO2 fraction in ambient air, and pH2O is the partial water vapor pres-
sure of saturated air at 37 °C, and p(amb) is the barometric pressure.
Status
In connection with the sensitivity calibration done on ambient air, also the CAL 1 solu-
tion is measured to obtain a status. This status aims to check the performed calibra-
tion. This is done by a compare the measured value of the CAL 1 solution to the refer-
ence value of CAL 1, given by the smart chip:
pO2(status,cal) = pO2(CAL 1, cal) - pO2(CAL 1, ref)
For every measurement, the pO2 calibration is checked by a compare of the measured
value of CAL 1 solution to the value obtained on the CAL 1 solution of the last calibra-
tion (CAL 1, cal):
pO2(status, meas) = pO2(CAL 1,meas) - pO2(CAL 1, cal)
The CAL 1 solution is used to do a status calibration of the pO2 sensor. The measured
value of the CAL 1 solution is compared to the reference value of the CAL 1 solution
that is read from the smart chip of the Solution Pack.
pO2(status,cal) = pO2(CAL 1,meas) - pO2(CAL 1, ref)
The status calibration of the pO2 sensor is done before every measurement. The meas-
ured value of the CAL 1 solution is compared with the value obtained during the
previous status calibration to determine the status drift:
pO2(status,drift) = pO2(CAL 1,meas) - pO2(CAL 1,prev cal).
Measurement - pO2 sensor
Calculation of pO2 values
On blood, pO2 is adjusted with the sensitivity value and the measured pO2 is therefore
determined as follows:
pO2 (meas )
pO2 ( sens,adjusted) =
S
The measured value is applied as a second-order blood correction, to compensate for

the varying buffer value of blood, as a function of pO2 tension. A second-order correc-
tion is applied:
pO2(display) = k1pO22 + k2pO2 + k3
Note: Air bubbles in samples may collect in front of the pO2 sensor and cause incorrect
results. However, the analyzer will detect them and attach a message to the results.
357
Metabolite sensors
Construction - metabolite sensors
Construction
The cGlu and cLac sensors are three-electrode sensors which consist of an internal
silver/silver chloride reference electrode, a platinum auxiliary electrode, and a platinum
anode. The sensors are covered by a multi-layer membrane bound to the sensor board.
1
2
5
3
6 4 6
7
1 Biocompatible layer – Biocompat- 5 Reference – Ag/AgCl electrode

ible layer
2 Outer membrane – Outer 6 Anode – Platinum electrode

membrane permeable to
glucose/lactate – diffusion control
3 Enzyme layer – Contains 7 Cathode – Platinum electrode

glucose/lactate oxidase
4 Inner membrane – Cellulose 8 Sensor base – The structural plat-

acetate form on which the sensor is formed
Zero current
The zero current is a small background current measured at the electrode when no
cGlu/cLac is present in a solution. As CAL 1 solutions contain no cGlu/cLac, a baseline
that represents the zero current, I0 as a function of time (I0 = f(t)), is obtained from
continuous measurements on CAL 1 solutions.
This I0 baseline is obtained as follows:

• At the end of a rinse, with CAL 1 solution in the measuring chamber, the zero
current of the metabolite electrodes is measured periodically.
• The previous N (N = 8) measurements on the CAL 1 solution - before a calibration
or a sample measurement starts - are used to obtain a baseline that represents the
time function of I0.
• The baseline is extrapolated throughout the whole electrode calibration or sample
measurement period, and represents the zero current time function.
• The I0 baseline is used in the determination of the sensitivity of the cGlu/cLac
sensor.
358
Calibration - metabolite sensors
Calculation of sensitivity
The sensitivity of the cGlu and cLac sensors is calculated by measuring the current
from CAL 3 solution, then subtracting the zero current as measured from CAL 1 solu-
tion. CAL 3 solution has a nominal glucose concentration of 10 mmol/L and a nominal
lactate concentration of 10 mmol/L. The precise values are specific to the individual lot
of the Solution Pack and are contained in the Solution Pack smart chip.
The current at the cGlu and cLac sensors with CAL 3 solution in the measuring
chamber is measured at regular intervals after the chamber is filled with solution. The
current, when signal stability is reached, is used to determine the sensitivity of the
cGlu or cLac sensor.
The sensitivity of the cGlu or cLac sensor is calculated as follows:
Ical3 -I0
S=
c cal
where I0 is the zero current extrapolated to the time of measurement from the 8
samples taken on CAL 1 solution.
Status is defined as I0.
Measurement - metabolite sensors
Calculation of metabolite values
The glucose or lactate concentration in a sample is calculated from the equation shown
below, where the difference between the current in the sample and the extrapolated
zero current from the rinse solution is used:
Isample -I0
c=
S
The measured value is found after this linear correction has been applied:
Note: cLac is compensated for the dependence of the ionic composition by the use of
the measured electrolyte values before the linear correction is applied. If the electro-
lytes are not measured, default values are used.
Sensor response stability of the metabolite sensors
For CAL 1 solution, the sensor response stability is defined as the standard deviation of
the last 5 calculated status calibration values.
For CAL 3 solution, the sensor response stability is defined as the standard deviation of
a linear regression for the last 5 calculated status calibration values, normalized with
the signal magnitude.
359
Measurement principle - metabolite sensors
Amperometric measurement principle
The cGlu and cLac sensors are measured according to the amperometric measurement
principle, in which the magnitude of an electrical current that flows through an elec-
trode chain is related to the concentration of a substance that is oxidized or reduced at
an electrode in the chain.
Electrode chain
The electrode chain set up to measure glucose/lactate is illustrated in the diagram:

1
7
6 2
5
3
4
1 Amperemeter – Measures the 5 Electrolyte – Provides electrical

current that flows through the contact between the anode and
circuit in nanoamperes cathode
2 Cathode – Negative electrode 6 Anode – Positive electrode where

where a reduction reaction occurs an oxidation reaction occurs and
and electrons are consumed electrons are released
3 Membrane – Lets the appropriate 7 Applied voltage – Applies the

molecules to pass through from the necessary potential for the reduc-
sample tion or oxidation reaction under
study
4 Sample – Contacts the membrane
Note: Note that polarization voltage is applied between the anode and the reference
electrode (not shown). The current runs through the anode and cathode chain.
Measurement process
A constant polarization voltage is applied to the electrode chain. The current through
this chain is measured by an amperemeter.
Glucose or lactate molecules, in solution, are transported across the outer layer of a
multilayer membrane system. The enzymes glucose oxidase or lactate oxidase, immo-
bilized between the outer and inner layers, converts glucose/lactate according to these
reactions:
Glucose: Glucose + H2O + O2 ® Gluconic Acid + H2O2
360
Lactate: Lactate + H2O + O2 ® Pyruvate + H2O2
The oxygen for this reaction is supplied by the membrane system as well as by the
oxidation of H2O2 at the platinum anode.
The H2O2 produced by the enzyme reaction is transported across the inner membrane
to the platinum anode.
When a potential is applied to the electrode chain, the oxidation of H2O2 produces an
electrical current proportional to the amount of H2O2, which in turn is directly related
to the amount of glucose/lactate.
H2O2 ® 2H+ + O2 + 2e-
At the counter electrode a reduction process that consumes electrons will occur:
1. H2O2 + 2e- ® 2OH- (This process consumes excess H2O2 not consumed in the
reaction above)
2. ½O2 + H2O + 2e- ® 2OH- (This process consumes excess O2 not consumed in the
reaction above)
3. 2H2O + 2e- ® H2 + 2OH- (This process can also occur at the cathode)
Any of these three reactions at the cathode will serve to neutralize the protons gener-
ated in the second reaction, so the total change in acidity is caused by the gluconic
acid/pyruvate only.
ctHb and derivates
Description of the optical system
Measured parameters
The optical system of the ABL90 FLEX analyzer is designed to measure these parame-
ters:
Parameter Description
ctHb Concentration of total hemoglobin
sO2 Oxygen saturation
FO2Hb Fraction of oxyhemoglobin
FCOHb Fraction of carboxyhemoglobin
FHHb Fraction of deoxyhemoglobin
FMetHb Fraction of methemoglobin
FHbF Fraction of fetal hemoglobin
ctBil* Concentration of total neonatal bilirubin (the sum of unconjugated and conjugated
bilirubin) in plasma
361
Note: ctBil* can be measured on blood or plasma samples. Plasma samples provide
the optimal measurement performance. To obtain optimal accuracy when following a
patient trend in ctBil*, use the same sample type and the same analyzer.
Construction
The optical system is based on a 256-wavelength spectrophotometer with a measuring

range of 467-672 nm. The spectrophotometer is connected via an optical fiber to a
combined hemolyzer and measuring chamber.
1
2
8
7
3
4 9
6 10
5 11
1 Spectrophotometer 7 Hemolyzer
2 Array of photodiodes 8 Hemolyzing unit
3 Grating 9 LED light source
4 Mirrors 10 Cuvette
5 Slit 11 Sample
6 Optical fiber cable
Measurement cycle
The method used in the analyzer's optical system is visible absorption spectroscopy.
The measurement cycle is as follows:
1. The blood sample is transported to the cuvette in the hemolyzer unit. The temper-
ature of the cuvette is adjusted to 37 °C.
2. A back pressure is exerted on the sample. This one atmosphere over-pressuriza-
tion is maintained during the hemolyzation and measurement to remove air
bubbles in the sample and to enhance the hemolyzation process.
3. The 1-µL sample in the cuvette is ultrasonically hemolyzed at a frequency of about
30 kHz. This hemolyzation process ruptures the walls of the red blood cells and the
content of the red blood cells is evenly mixed with the plasma and an optically
clear solution is produced.
4. Light from a white LED is sent into the cuvette and the light is transmitted through
the cuvette via an optical fiber to the spectrophotometer.
5. The light passes through a slit that points the light towards an arrangement of
mirrors and a grating.
6. The grating divides the light into the colors of the rainbow and the mirror focuses
the light on a photodiode array.
362
7. The photodiode array, which has 256 diodes or pixels, one for each wavelength,
converts the monochromatic light signals to currents.
8. The currents are measured at each of the 256 diodes. The currents form the basis
for the absorption spectrum for a particular sample.
9. The spectrum is sent to the analyzer, which calculates the oximetry parameter
values.
Lambert-Beer's law
Absorption spectroscopy is based on Lambert-Beer's law, which states that the meas-
ured absorbance for a single compound is directly proportional to the concentration of
the compound and the length of the light path through the sample [2]:
l l
Ay = e y ´ cy ´ l
Where:
l
Ay = absorbance of compound y at wavelength λ
l
e y
= extinction coefficient of compound y at wavelength λ (a constant, characteristic of
the compound)
cy = concentration of compound y in sample
l = length of the light path
Absorbance
The absorbance (A) of a compound is defined as the logarithm of the ratio of the light
intensity before and after transmission through the compound.
In practice it is the logarithm of the ratio of the light intensity transmitted through
water to the light intensity transmitted through the compound.
I0
A = log
I
Where:
Io = intensity of light transmitted through water (I0 is measured as the intensity of

light transmitted through CAL 3 solution)
I = intensity of light transmitted through the compound
Total absorbance
For samples that contain more than one optically active compound, the total absorb-
ance (Atotal) is the sum of the individual compounds' absorbance, since absorbance is
an additive quantity.
For example, if a sample contains six compounds y1, y2, ….y6, the total absorbance
measured for that sample at wavelength λ 1 is:
l l1 l1 l1 l1 l1 l1
A 1 = Ay + Ay + Ay + Ay + Ay + Ay
total 1 2 3 4 5 6
( l1 l1 l1 l1
= l e y cy1 + e y cy2 + e y cy3 + e y cy4 + e y cy5 + e y cy6
1 2 3 4
l1
5
l1
6
)
If there are Y compounds and measurements are made at n wavelengths, a general
expression can be written for Atotal at the wavelength λn:
363
Y
å e yl
l
A n
= n
´ cy ´ l
total
y =1
Where:
λn = the individual wavelengths.
Continuous spectrum
ln
Atotal can be depicted graphically as a function of wavelength, and if the differences
between the wavelengths are small enough, a continuous spectrum is produced.
Spectrum example
The figure below shows three spectra; pure O2Hb, pure HHb at a low concentration, a
spectrum of 92% oxygenated hemoglobin that is obtained by adding the spectra of
O2Hb and HHb. The additivity of absorption and the continuity of the spectra can be
seen.
1
3
5
2
480 500 520 540 560 580 600 620 640 660 680
1 Absorption 4 FO2Hb (9.2 mmol/L)
2 Wavelength (nm) 5 FHHb (0.8 mmol/L)
3 92% FO2Hb, 8 % FHHb
Determining concentrations
In the measured spectrum of a sample, the absorption recorded at each wavelength

contains contributions from each of the compounds in the sample. The task then is to
determine the magnitude of that contribution and thereby the concentration of each
compound in the sample.
The concentrations are determined as follows:

138
cy = å K l Al
n =1
y
n n
total
λ
Where K yn = a constant specific to compound y at wavelength λn.
Matrix of constants
λ
The constants ( K yn ) are determined by the use of the Multivariate Data Analysis [2]
where the spectra of the calibration compounds are considered together with the refer-
364
ence values of the calibration compounds. The essential interfering substances (intrali-
pids and sulfhemoglobin) were also taken into account.
Calibration of the optical system
Calibration materials
The optical system is calibrated at two points by the use of these solutions:
• The S7770 ctHb Calibration Solution with a known dye concentration to determine
the cuvette path length, l.
• A transparent solution from the Solution Pack in the analyzer to determine the zero
point, Io.
Zero point
The zero point, Io, is the current (or intensity) measured by the photodiode array on
the transparent solution in the cuvette. During this blank calibration the ctHb is cali-
brated to this zero point.
Io is measured automatically during system start up and during calibrations.
Cuvette path length
The cuvette path length (i.e. the length of the light path) is determined from
Lambert-Beer's Law by measuring the absorbance of the colored dye present in the tHb
Calibration Solution (S7770), which has a known equivalent hemoglobin concentration.
Beer's Law: A = ε x Cdye × l
Where
A = absorbance
ε = extinction coefficient
Cdye = concentration of colored dye
l = length of light path
Correcting for interferences
HbF versus HbA
Fetal hemoglobin (HbF) does not have the same spectrum as adult hemoglobin (HbA)
due to a slight variation in molecular structure. The presence of HbF in a sample will
interfere with the result if a correction is not made.
Therefore, when hemoglobin levels are measured in samples from premature neonates
and neonates aged 0-3 months, as well as from adults who suffer from e.g. thalas-
semia, it is important to take into account this difference [4], and to make sure that
the analyzer automatically corrects for HbF.
Note: The analyzer only compensates for interference caused by the presence of HbA
and HbF.
The diagram shows the transition from fetal hemoglobin to adult hemoglobin [5].
365
%
100
1 HbF HbA
80
60
40
20
0 2
-6 -3 0 3 6
1 Hemoglobin 2 Months
This graph is only schematic and cannot be used to determine FHbF.
Deviation of results
If the difference between the adult and fetal types of hemoglobin is not taken into
account in measurements on samples that contain HbF (e.g. from premature neonates
and neonates aged 0-3 months) then a deviation in the measurement will occur.
The deviation is most important for measurements of oxygen saturation (sO2 and
FO2Hb) and the fraction of carboxyhemoglobin (FCOHb), since inaccurate measure-
ments of these parameters can lead to incorrect diagnostic interpretation of the
results, and consequent risk of inappropriate treatment.
Detecting HbF
The presence of HbF in a sample is detected by measuring the difference between the
spectra of fetal and adult oxyhemoglobin. Fetal oxyhemoglobin, cO2HbF, is determined
by the difference.
Correcting for HbF
The amount of cO2HbF that exceeds a certain level indicates HbF interference. The
analyzer automatically corrects for this interference by subtracting the difference spec-
trum of fetal oxyhemoglobin from the measured spectrum.
Repressing spectra
Repressing the spectra of the likely interfering substances is done in two ways
depending on the substance:
• Either the substance is taken account of in the calculation of the matrix of
constants, K. This applies to Intralipids and Sulfhemoglobin.
• Or the substance is detected, and the measured spectrum is corrected accordingly.
This applies to HbF.
Residual spectrum
The measured spectrum is compared to a model spectrum calculated from the deter-
mined concentrations. The difference between these two spectra is called the residual
366
spectrum. If this residual spectrum is too high, the oximetry module parameters ctHb,
sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF and ctBil* will be flagged with a warning.
In addition, a warning will accompany the results if any of these conditions exist:
• ctHb <–0.1 mmol/L or ctHb >25 mmol/L
• FHb(deriv) <–2 % or FHb(deriv) >102 % where FHb(deriv) is defined as sO2,
FO2Hb, FCOHb, FMetHb, FHHb
• SHb <–2 % or SHb >10 %
• Value of turbidity <- 0.5 % or > 5 %
Measurement and corrections
Calculation of the values of the oximetry parameters
The oximetry parameters are calculated as follows:
Parameter Equation
ctHb(meas) = cO2Hb + cCOHb + cHHb + cMetHb
sO2 cO2Hb
=
ceHb
ceHb = cHHb + cO2Hb (effective hemoglobin)
FO2Hb cO2Hb
=
ctHb
FCOHb cCO2Hb
=
ctHb
FHHb cHHb
=
ctHb
FMetHb cMetHb
=
ctHb
FHbF cHbF
=
ctHb
Calculation of bilirubin* values
Bilirubin is calculated as follows:
ctBil(B)
ctBil(P)=
1 - Hct(calc)
Where:
ctBil*(P) = concentration of total neonatal bilirubin in plasma
ctBil*(B) = concentration of neonatal diluted plasma bilirubin after sample hemolyzation
367
Hct(calc) = calculated hematocrit (a fraction):
0.0301
Hct(calc)= ´ ctHb
g/dl
For further details on Hct(calc) please refer to Interference Tests and the explana-
tion of MCHC (Mean Corpuscular Hemoglobin Concentration) in this manual.
Restrictions
These parameters will not be calculated:
Parameter Is not calculated if…
sO2, FCOHb, FMetHb, FHHb, FO2Hb ctHb<1 mmol/L
sO2 ceHb = cHHb + cO2Hb <0.75 mmol/L
ctBil* ctHb > 14.27 mmol/L
To correct for the presence of HbF in a sample, these conditions are required:
Parameter or settings Conditions
ctHb Concentration >5 mmol/L
FCOHb Concentration <20 %
FMetHb Concentration <10 %
HbF correction setting - cO2HbF/ctHb should be more than 0.2

“Enabled for levels > 20
%”
HbF correction setting - No lower limit value for cO2HbF is required. Even adult blood
“Enabled for all levels” samples will be corrected for HbF. This setting may be of value
when you analyze blood samples from newborns who have
received adult blood transfusion. In these cases FHbF can be lower
than 20% and significant deviations of oximetry parameters and
bilirubin* can occur.
HbF correction setting - No HbF corrections are made

“Disabled”
HbF correction has been The message “Oxi compensated for HbF” is attached to the result
enabled
sO2<50% The message “FHbF measurement not possible” is shown by the

analyzer, if a HbF suppression has been activated, and the FHbF
estimation from cO2HbF is too uncertain
368
Corrections for ctHb
The uncorrected hemoglobin concentration, ctHb(sample), measured on capillary or

syringe samples is corrected as follows:
ctHb(sample)
ctHb(sample,corr)=
Fcuv
Where:
ctHb(sample,corr) = corrected ctHb
Fcuv = analyzer-dependent cuvette path length constant determined at tHb cali-

brations and automatically saved by the analyzer
Corrections for ctBil*
The uncorrected total bilirubin concentration, ctBil*(sample), measured on capillary or

syringe samples is corrected as follows:
ctBil(sample)
ctBil(sample,corr)=
Fcuv
Fcuv is the same as for tHb.
References
1. Ewing GW. Instrumental methods of chemical analysis. 5th ed. McGraw.Hill, 1985.
2. Martens H. Multivariate calibration: quatitative interpretation of non-selective
chemical data: Dr. Techn. Thesuis. NTH Univ. of Trondheim, 1986.
3. Krzeminski A. Why correct for fetal hemoglobin in blood oximetry measurements?
Radiometer Publication Info. No. 1992-3. Copenhagen: Radiometer Medical A/S,
1992.
4. Huehns ER, Beanen GH. Developmental changes in human hemoglobins. Clin Dev
Med 1971; 37: 175-203.
369
370
Specifications 13
Analyzer specifications
Ranges of indication and reportable ranges
Parameter Unit Range of indication* Reportable range
pH pH scale 6.3-8.0 6.818-7.797
pCO2 mmHg; Torr 5-250 15.4-98.3
kPa 0.67-33.3 2.05-13.1
pO2* mmHg; Torr 0-800 30.1-488
kPa 0-107 4.0-65.0
ctHb g/dL -0.48-27.7 0.1-24.0
g/L -4.8-277 0.8-240
mmol/L -0.30-17.2 0.05-14.9
sO2 % -2-102 3.3-100.0
Fraction -0.02-1.02 0.033-1.000
FO2Hb % -2-103 3.3-98.5
Fraction -0.02-1.03 0.033-0.985
FCOHb % -2-103 1.00-92.2
Fraction -0.02-1.03 0.010-0.922
FMetHb % -2-103 1.00-91.0
Fraction -0.02-1.03 0.010-0.910
FHHb % -2-102 2.4-98.5
Fraction -0.02-1.02 0.024-0.985
FHbF % -25-121 21-83
Fraction -0.25-1.21 0.21-0.83
cK+ mmol/L; meq/L 0.5-25 2.1-10.5
cNa+ mmol/L; meq/L 7-350 116-180
cCa2+ mmol/L 0.1-9.99 0.50-2.48
meq/L 0.4-19.98 1.00-4.96
371
Chapter 13: Specifications ABL90 FLEX: Instructions for use
Parameter Unit Range of indication* Reportable range
cCa2+ mg/dL 0.8-40.04 2.00-9.92
cCl- mmol/L; meq/L 7-350 86-151
cGlu** mmol/L 0-60 0.5-41
mg/dL 0-1081 9-738
cLac mmol/L; meq/L -0.1-31 0.4-24
mg/dL -1-279 4-216
ctBil*** µmol/L –20-1000 28-648
mg/dL –1.2-58.5 1.6-37.9
mg/L –12-585 16-379
the Reportable range specified in the table has not been validated. Only results within
the Reportable range should be reported.
** See Related information.
*** Bilirubin can only be measured on neonatal samples. This parameter is only avail-
Related information
pO2 levels - how they affect cGlu results, page 229
Measurement precision within specified ranges
The table shows the precision (number of decimals) of the parameters within the
ranges shown. The ranges should be taken into consideration when external systems
are interfaced to the analyzer.
Parameter symbol Unit Lower range Upper range
Lower limit Upper limit Lower limit Upper limit
pH - 4.000 11.000
pH(T) - 4.000 11.000
cH+ nmol/L -999999.0 199.9 200 9999999
cH+(T) nmol/L -999999.0 199.9 200 9999999
pCO2 mmHg 0.0 99.9 100 750
kPa 0.00 9.99 10.0 100.0
pCO2(T) mmHg 0.0 99.9 100 750
kPa 0.00 9.99 10.0 100.0
cHCO3–(P) mmol/L 0.0 100.0
cBase(B) mmol/L -50.0 50.0
cBase(B,ox) mmol/L -100.0 100.0
cBase(Ecf) mmol/L -50.0 50.0
372
ABL90 FLEX: Instructions for use Chapter 13: Specifications
cBase(Ecf,ox) mmol/L -100.0 100.0
cHCO3– (P,st) mmol/L 0.0 150.0
ctCO2(P) mmol/L 0.0 100.0
Vol % 0.0 224.1
mL/dL 0.0 224.1
ctCO2(B) mmol/L 0.0 100.0
Vol % 0.0 224.1
mL/dL 0.0 224.1
pH(st) - 4.000 11.000
VCO2/V(dry air) % -10.0 110.0
fraction -0.100 1.100
Hct % -10.0 110.0
fraction -0.100 1.100
pO2 mmHg 0.0 99.9 100 2500
kPa 0.00 9.99 10.0 99.9
100 300
pO2(T) mmHg 0.0 99.9 100 750
kPa 0.00 9.99 10.0 99.9
100 300
pO2(A) mmHg 0.0 750.1
kPa 0.00 100.00
pO2(A,T) mmHg 0.0 750.1
kPa 0.00 100.00
p50 mmHg 0.00 750.06
kPa 0.00 100.00
p50(T) mmHg 0.00 750.06
kPa 0.00 100.00
p50(st) mmHg 0.00 750.06
kPa 0.00 100.00
pO2(A-a) mmHg 0.0 750.1
kPa 0.00 100.00
pO2(A-a,T) mmHg 0.0 750.1
373
pO2(A-a,T) kPa 0.00 100.00
pO2(a/A) % 0.0 10000.0
fraction 0.000 100.000
pO2(a/A,T) % 0.0 10000.0
fraction 0.000 100.000
pO2(a)/FO2(I) mmHg 0.0 99.9 100 7501
kPa 0.00 9.99 10.0 1000.0
pO2(a,T)/FO2(I) mmHg 0.0 99.9 100 7501
kPa 0.00 9.99 10.0 1000.0
pO2(x) mmHg 0.0 750.1
kPa 0.00 100.00
pO2(x,T) mmHg 0.0 750.1
kPa 0.00 100.00
ctO2(B) mmol/L 0.0 100.0
Vol % 0.0 224.1
mL/dL 0.0 224.1
ctO2(a-v̄) mmol/L 0.0 100.0
Vol % 0.0 224.1
mL/dL 0.0 224.1
BO2 mmol/L 0.0 100.0
Vol % 0.0 224.1
mL/dL 0.0 224.1
ctO2(x) mmol/L 0.0 100.0
Vol % 0.0 224.1
mL/dL 0.0 224.1
ḊO2 mL/min 0 22414
mmol/min 0.0 1000.0
Q̇t L/min 0.0 100.0
V̇O2 mL/min 0 22414
mmol/min 0.0 1000.0
FShunt % -10.0 110.0
fraction -0.100 1.100
374
FShunt(T) % -10.0 110.0
fraction -0.100 1.100
RI % -10 999900
fraction -0.10 9999.00
RI(T) % -10 999900
fraction -0.10 9999.00
Qx fraction -0.10 10.0
V(B) L 0.0 20.0
Anion Gap, K+ mmol/L -500.0 500.0
meq/L -500.0 500.0
Anion Gap mmol/L -500.0 500.0
meq/L -500.0 500.0
cCa2+ (7.4) mmol/L 0.00 50.00
meq/L 0.00 100.00
mg/dL 0.00 200.40
mOsm mmol/kg -0.7 3150.0
Pressure (Baro.) mmHg 98 1500
kPa 13.0 200.0
ctHb g/dL -0.81 0.99 1.0 80.6
g/L -8.1 9.9 10 806
mmol/L -0.50 0.99 1.0 50.0
sO2 % -1000.0 1000.0
fraction -10.000 10.000
FO2Hb % -1000.0 1000.0
fraction -10.000 10.000
FCOHb % -1000.0 1000.0
fraction -10.000 10.000
FMetHb % -1000.0 1000.0
fraction -10.000 10.000
FHHb % -1000.0 1000.0
fraction -10.000 10.000
FHbF % -100 200
375
FHbF fraction -1.00 2.00
cK+ mmol/L 0.0 100.0
meq/L 0.0 100.0
cNa+ mmol/L 0 1500
meq/L 0 1500
cCl- mmol/L 0 1000
meq/L 0 1000
cCa2+ mmol/L 0.00 50.00
meq/L 0.00 100.00
mg/dL 0.00 200.40
cGlu mmol/L -1.0 24.9 25 150
mg/dL -18 2702
cLac mmol/L -1.0 14.9 15 100
meq/L -1.0 14.9 15 100
mg/dL -9 901
Product specifications
Specification Value
Height 17.7 inches with the screen in a vertical position
Width 9.8 inches
Depth 11.4 inches
Weight 24.4 lbs
Noise levels In front of the analyzer, when no activities are done: >27 dB.
During automatic activities: >36 dB.
During measurements and when data is printed: >55 dB.
Volume of sample 65 µL
necessary for
aspiration
Measuring time 35 seconds from the time the sample is aspirated until the results are shown
Measurement 60 seconds from the time the sample is aspirated until the analyzer is ready
cycle time to analyze the next sample.
The time may be different during Start Up.
Number of ≥44 samples per hour.

samples per hour
During Start up: ≥15 samples per hour.
376
Specification Value
Data storage Patient profiles Maximum 2000 patient profiles.

capacity log
Note: This number can be increased. Contact your local
Radiometer service representative to request this option.
Patient results log Maximum 2000 results
Activity log Maximum 5000 activities
Calibration log Maximum 1000 results
Quality control Maximum 2000 results

log
Replacements log This log is part of the Activity log
Archived data 500 results from each log and 2000 activities from the
logs Activity log
System messages This log is part of the Activity log
External serial 1 × RS-232 (9-pin) connector. Baud rate: 1200, 2400, 4800, 9600, 14400,
port 19200, 38400.
USB ports 3 (1 at the top and 2 in the back of the analyzer).
Note: Only the USB port at the top of the analyzer can be used for the WIFI
Adapter.
Ethernet 1 × RJ45 connector, 100Base-Tx Fast Ethernet
Keyboard/mouse PS/2
port
External VGA Connector for VGA screen (disabled in BIOS setting)

screen port
External commu- High-level protocols:

nication protocols • ASTM
• ASTM6xx
• HL7 ver. 2.2
• HL7 ver. 2.5
• POCTDML1A
Low-level protocols:
• Serial
• Serial(Raw)
• Network(TCP/IP)
• Network(TCP/IP)(RAW)
• Network(TCP/IP)(ASTM)
Display • 8" TFT-LCD, resolution 800 x 600 VGA

• Resistive touch screen
Built-in printer Thermal printer
Built-in barcode • Reading distance: 0-70 mm

reader (under the
• Bar code width: ≥127 µm
screen)
• Number of characters: <62
• Accepted codes: Code 128, Code 39, Code 93, Interleaved 2 of 5,
Codabar
377
Specification Value
Laser specifica- Contains 1 laser that is in compliance with international standard (IEC
tions 60825-1 Safety of laser products) and US requirements (21 CFR 1040.10 -
LASER PRODUCTS).
Thermostat Solid state, 37.0 ±0.15 °C (Oxi: ±0.3 °C)
Battery pack Operation time: Approximately 45 minutes including 10 measurements
Charge time: Approximately 90 minutes to fully charge a flat battery
Voltage: 24 V
Power consump- 49 W/hour

tion:
Fuses Main fuse has two protective fuses: 5 x 20 mm, 2.5A HRC (F) 250 VAC
WiFi Supported Belkin Surf N150 Micro WLAN USB Adapter, (code
connector number F7D1102)
Data transfer rate Up to 150 Mbit/s
Data link proto- • IEEE 802.11b

cols/standards
• IEEE 802.11g
• IEEE 802.11n
Supported • Open
authentication
• WPA/WPA2
Supported • None/WEP
encryption
• TKIP/AES
settings
Contact your local Radiometer representative to request this option.
Operating 15 °C to 32 °C
temperature
Environmental specifications
Specification Value
Location Intended for indoor use
Maximum altitude 3000 m
Ambient temperature 15-32 °C
Relative humidity 20-80 %
Barometric pressure At 15-30 °C: 525-800 mmHg
70.0-106.7 kPa
0.700-1.067 bar
378
Specification Value
Barometric pressure At 15-30 °C: 525-800 Torr
At 30-32 °C 600-800 mmHg
80.0-106.7 kPa
0.800-1.067 bar
600-800 Torr
Mains power supply Rated voltage: 100-240 V ±10 %; 50/60 Hz.
Average power consumption: <60 W
Maximum power consumption: 90 W (during Start Up <106 VA for

less than a second)
Maximum voltage fluctuations: ±10 %
Class 1 power supply
Pollution degree 2 (occasional/temporary conductivity caused by condensation)
Heat dissipation <60 W
Start Up Without the metabolite sensors: Up to 2 hours.
With the metabolite sensors: Up to 4 hours.
Start up is the period of time from when the Sensor Cassette was
installed and 3 levels of automatic QC are done. It includes the
conditioning of the Sensor Cassette, calibration and QC cycles.
Ventilation The analyzer must be in a well-ventilated room to ensure proper

functioning.
EMC immunity The equipment complies with the immunity requirements in EN

61326-2-6: Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 2-6 Particular require-
ments - In vitro diagnostic (IVD) medical equipment
EMC emission The equipment complies with the emission requirements for Class A
equipment in EN 61326-1: Electrical equipment for measurement,
control and laboratory use - EMC requirements part 1: General
requirements.
Space requirement Sufficient space in front and on the sides of the analyzer to prevent
it overheating.
Do not put the analyzer in an enclosure.
Easy access to the mains power switch that connects the analyzer to
the mains.
Storage temperature -20 °C to 60 °C
379
Power-supply cords
Country Power-supply cord specifications
For USA (125 UL listed and KAM cord, min. type SV, min. 18 AWG, 3 conductors. Rated min.
VAC) 60 C.
Provided with a molded grounding-type (NEMA 5-15P) attachment plug rated

125 VAC, min. 2.5 A.
Opposite end terminates in molded IEC 320 style connector rated 125 VAC,
min. 2.5 A.
The power-supply cord and plug of the analyzer must comply with national regulations.
If the regulations are not complied with, the equipment may be damaged.
External devices connected to the analyzer must be in compliance with the standard UL
60905 for US and IEC 60950 for Europe. If you do not do this, the equipment may be
damaged.
Analytical sensitivity – ctBil*
To establish reportable ranges for neonatal ctBil*, limit of quantitation (LoQ) was
determined.
Parameter Limit of blank (LoB) Limit of detection Limit of quantitation

(LoD) (LoQ)
ctBil* (mg/dL) 1.1 1.6 1.6
The study followed the guideline CLSI EP17-A2. Evaluation of Detection Capability for
Clinical Laboratory Measurement Procedures. Approved Guideline – 2nd Edition. CLSI
document EP17-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
Consumables specifications
Solution Pack
Intended use of the Solution Pack
For calibration of sensors, quality control, evaluation of accuracy and precision, rinse of
measuring system and collection of waste from the analyzer.
Solution Pack specifications
Specification Details
Number of activ- Depends on the Solution Pack version. An activity can be a patient or QC
ities measurement, a calibration or a rinse.
Storage temper- 2-25 °C

ature
380
Storage 20-80 %
humidity
Shelf life Stable until the expiration date printed on the Solution Pack label
On-board 30 days
stability
Expiration date See the date printed on the Solution Pack label
Contents • 3 pouches with quality control material

• 3 pouches with calibration material
• 1 pouch with gas mixture
• 2 pouches to hold waste
Chemical Reactive ingredients: See the table below

composition
Other ingredients: Biological buffers, salts, enzyme, heparin, surfactant, pres-
ervative
Certificates of Contact your local Radiometer representative

traceability
Material safety Contact your local Radiometer representative

data sheet
(MSDS)
Approximate levels of measurands in the solution pack
Solution pH pCO2 pO2 *cNa+ *cK+ *cCl– *cCa2+ *cGlu *cLac *ctHb
type mmHg mmHg
S9030 7.2 30 180 140 4 105 0.8 0 0 0
S9040 6.8 67 N/A 118 7 95 1.65 15 8 8
S9050 7.5 20 20 175 1.8 125 0.3 7 4 12
S1920 7.30 35 180 150 4 95 0.5 0 0 N/A
S1930 6.8 N/A N/A 70 10 50 2.3 N/A N/A N/A
S1940 N/A 80 N/A N/A N/A N/A N/A 10 10 0
* Measured in mmol/L
** Bilirubin can only be measured on neonatal samples. This parameter is only avail-
Volume of solutions in the Solution Pack
Solution name Solution type Volume (mL)
QC 1 S9030 200
QC 2 S9040 100
QC 3 S9050 100
CAL 1 S1920 200
CAL 2 S1930 100
CAL 3 S1940 100
381
Chemical composition of the gas mixture in the Solution Pack
Volume (mL) Reactive ingredients
O2 % CO2 % N2
150 (at sea level) 42.07 5.61 52.32
Sensor Cassette
Intended use of the Sensor Cassette
For the measurement of the parameters shown on the label of the box that contains
the Sensor Cassette Pack.
Sensor Cassette specifications
Number of tests Depends on the Sensor Cassette version
Storage tempera- 2-8 °C

ture
Storage humidity 20-80 %
Shelf life When kept in its sealed container, the Sensor Cassette is stable until the
expiration date printed on the label of the pack
On-board stability 30 days
Expiration date See the date printed on the label of the pack
Contents One Sensor Cassette in a sealed container
382
Graphical symbols 14
Explanation of graphical symbols/icons
These are the symbols and icons you may find on the analyzer and the consumable
products used with it.
Symbol/icon Explanation
Syringe position
Capillary position
Sample mixer
Do not open the inlet when this symbol is shown on the screen
Keep dry
Do not use if package is damaged
Do not re-use
Use by
Contains sufficient for <n> tests
Temperature limit
Lot no.
Catalog no. (product code)
Consult instructions for use
Manufacturer
in vitro diagnostic medical device
383
Chapter 14: Graphical symbols ABL90 FLEX: Instructions for use
Symbol/icon Explanation
Biohazard
Keyboard
CE marking of conformity
COM gate (scanner/barcode reader)
VGA (monitor)
Mouse
Network
Off
On
UL certification
USB
Warning or caution
This symbol indicates that Radiometer Medical ApS and its distributors within the
European Union (EU) and associated states have taken the necessary steps to
comply with the "DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 4 July 2012 on waste of electrical and electronic equipment
(WEEE)".
Equipment marked with this symbol must not be disposed of as household waste
but as electronic waste in accordance with local legislation.
Please note that equipment contaminated with potentially infectious substances,

such as body fluids, must be decontaminated before recycling. If this is not
possible, the equipment must be disposed of as biohazardous material.
Contact your local Radiometer representative for instructions.
Marks compliance with SJ/T 11363-2006 (China RoHS). The number in the
symbol shows the environmentally friendly use period in years.
Marks compliance with SJ/T 11363-2006 (China RoHS). The product contains no
restricted substances above the prescribed thresholds.
384
Ordering information 15
Solution Packs - code numbers
Item Volume Code number (REF)
ABL90 FLEX solution pack 680 activities 944-157
944-197 (Germany only)
ABL90 FLEX solution pack 980 activities 944-457
944-497 (Germany only)
Sensor Cassettes - code numbers
Sensor Cassettes are available in different versions.
Abbreviations identify the parameters that each Sensor Cassette can measure.
• BG = pH, pCO2, pO2
• LYT = cCa2+, cK+, cNa+, cCl-
• MET = cGlu, cLac, ctBil*
• OXI = ctHb, sO2, FO2Hb, FMetHb, FCOHb, FHHb, FHbF
For USA
Number of tests On-board stability Code numbers (REF) for Sensor Cassette
versions
SC90 BG, LYT, SC90 BG, LYT, MET,

OXI + QC OXI + QC
100 30 days N/A 946-010
300 30 days N/A 946-005
600 30 days 946-013 946-008
900 30 days N/A 946-009
1200 30 days N/A 946-060
Spare parts and accessories - code numbers
Product Code number (REF)
Printer paper (8 rolls) 984-070
Clot Catcher for the ABL90 FLEX analyzer 906-026
385
Chapter 15: Ordering information ABL90 FLEX: Instructions for use
Product Code number (REF)
ABL90 FLEX Inlet Clip 925-047
ctHb Calibration Solution S7770 944-021
Inlet Probe 924-455
Inlet Gasket with Holder 924-816
Inlet Connector Gasket 834-662
Inlet Module 903-139
ABL90 FLEX Flush Device 905-918
ABL90 FLEX sBOX (spare parts and/or accesso- 905-917

ries for the inlet). Contact your Radiometer
representative for details.
Hypochlorite Solution S5362 943-906
ABL90 FLEX Roller Stand Kit (trolley for the 905-907

analyzer)
ABL90 FLEX Demo Bag (bag to transport the 985-267

analyzer)
Tubing for valve 841-797
Quality control products - code numbers
QUALICHECK5+ Solutions Code number (REF)
S7730 Level 1 (marked with a red color code) 944-017
S7740 Level 2 (marked with a yellow color 944-018

code)
S7750 Level 3 (marked with a blue color code) 944-019
S7760 Level 4 (marked with a green color 944-020

code)
Range+ QUALICHECK Solutions (for cali- Code number (REF)

bration verification use)
S7930 Level 1 944-151
S7940 Level 2 944-152
S7950 Level 3 944-153
Other QC products Code number (REF)
Ampoule Opener 920-712
QUALICHECK Adapter 924-646
QUALICHECK+ Tray 887-860
386
ABL90 FLEX: Instructions for use Chapter 15: Ordering information
Recommended Radiometer sampling devices - code numbers
Arterial syringe packs (100 Needle gauge and Volume Code number
syringes/pack) length (REF)
PICO50, 2 mL aspirator N/A 0.5-2.0 mL 956-552
PICO70 without a needle N/A 0.3-1.5 mL 956-518
PICO70 without a needle and a needle N/A 0.3-1.5 mL 956-519

cube
PICO70 22G × 1" 0.3-1.5 mL 956-522
PICO70 22G × 1 1/4" 0.3-1.5 mL 956-525
PICO70 23G × 5/8" 0.3-1.5 mL 956-529
PICO70 23G × 1" 0.3-1.5 mL 956-533
PICO70 23G × 1 1/4" 0.3-1.5 mL 956-534
PICO70 without a needle cube 23G × 5/8" 0.3-1.5 mL 956-546
PICO70 25G × 5/8" 0.3-1.5 mL 956-547
PICO70 without a needle cube 22G × 1" 0.3-1.5 mL 956-563
safePICO70 with a needle shield 22G × 1¼" 0.3-1.5 mL 956-608

device
safePICO70 with a needle shield 23G × 5/8" 0.3-1.5 mL 956-609

device
safePICO70 with a needle shield 23G × 1" 0.3-1.5 mL 956-624

device
safePICO syringe packs (100 syringes/pack) Volume Dimensions Code number

(REF)
safePICO Self-fill with a safeTIPCAP, but without a 0.7-1.5 mL N/A 956-610

needle
safePICO Self-fill with a safeTIPCAP and a needle 0.7-1.5 mL 23G × 5/8" 956-612
cube, but without a needle shield device
safePICO Self-fill with a safeTIPCAP and a needle 0.7-1.5 mL 22G × 1" 956-613
cube, but without a needle shield device
safePICO Self-fill with a safeTIPCAP and a needle 0.7-1.5 mL 22G × 1 1/4" 956-614
shield device
safePICO Self-fill with a safeTIPCAP and a needle 0.7-1.5 mL 23G × 5/8" 956-615
shield device
shield device
shield device
safePICO aspirator 0.7-1.7 mL N/A 956-622
387
Chapter 15: Ordering information ABL90 FLEX: Instructions for use
Capillary tubes, Description Volume Number of Capillary Code

glass vials tubes/vial number
(REF)
D957G-70-100×5 Capillary tubes with 100 µL 5 75 942-878

CLINITUBES balanced heparin,
mixing wires and
end caps
D956G-70-100×1 Capillary tubes with 100 µL 1 75 905-663

CLINITUBES balanced heparin,
mixing wires and
end caps
Capillary tubes, Description Volume Number of Capillary Code

plastic vials tubes/vial number
(REF)
D957P-70-70×1 Capillary tubes 70 µL 1 250 942-898

safeCLINITUBES with balanced
heparin, mixing
wires and end
caps
Power-supply cords - code numbers
Country Mains voltage Code number (REF)
USA and Japan 120 V 615-403
UK 230 V 615-312
Italy 230 V 615-313
Danmark 230 V 615-314
Israel 230 V 615-315
Switzerland 230 V 615-316
Australia and New Zealand 230 V 615-317
South Africa and India 230 V 615-318
All other countries 230 V 615-303
388
Legal information 16
Patents and trademarks
Patents
Radiometer products may be covered by one or more patents and patent applications.
See http://www.radiometer.com/en/legal/patents.
Trademarks
Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, AQURE, PICO,
CLINITUBES and QUALICHECK are trademarks of or used under license by Radiometer
Medical ApS.
Legal notices
System performance
The procedures described in this manual must be observed in order to ensure proper
system performance, and to avoid hazards.
Radiometer cannot provide or verify system performance characteristics if the system

is not installed, used and maintained in accordance with Radiometer procedures or if
accessories not meeting the specifications provided by Radiometer are used.
Radiometer warrants that the data media on which the software included in the system
is furnished is free from defects in material and workmanship under normal use for
three (3) months from the date of delivery as evidenced by a copy of invoice or
receipt.
Third-party software and trademarks
The ABL90 FLEX analyzer comprises the Microsoft® Windows® Embedded and Sybase®
SQL Anywhere® software.
By using the system, you accept the terms of the Software License Agreement(s) of
the provider(s) of the above software as shown in the End User License Agreement(s)
included in this manual. If you cannot accept the terms of the Software License Agree-
ment(s), you should not use the system, but immediately contact your provider for a
return of the system and a refund of the purchase price.
Microsoft® and Windows® are trademarks of Microsoft Corporation.
Sybase® SQL Anywhere® software is a trademark of Sybase Incorporated.
Warranties and disclaimer
Radiometer makes no warranties, express or implied, other than expressly stated.
389
Chapter 16: Legal information ABL90 FLEX: Instructions for use
Any warranties expressly stated in this document are conditional upon the system
being installed, used and maintained in accordance with Radiometer procedures,
including that only accessories meeting the specifications provided by Radiometer are
used.
Radiometer disclaims any liability for system performance if the system is not installed,
used and maintained in accordance with Radiometer procedures or if accessories not
meeting the specifications provided by Radiometer are used.
Further, Radiometer disclaims any liability for loss of data and direct, consequential or
other damages, including loss of profit or loss of business, whether such claim for
damages is based upon contract, negligence or tort (including strict liability), and even
if Radiometer has knowledge of the possibility of the potential damage or loss.
Confidentiality
The contents of this document shall not be reproduced or communicated to any third
party without the prior written consent of Radiometer.
Changes
This document is subject to change without notice.
While every effort is made to ensure the correctness of the information provided in this
document as changed from time to time, Radiometer disclaims any liability for errors
and omissions.
End-user license agreement with Microsoft
You have acquired a device (ABL90 FLEX analyzer) that includes software licensed by
Radiometer Medical ApS from Microsoft Licensing Inc. or its affiliates (MS). Those
installed software products of MS origin, as well as associated media, printed materials,
and online or electronic documentation (SOFTWARE) are protected by international
intellectual property laws and treaties. The SOFTWARE is licensed, not sold. All rights
reserved.
• IF YOU DO NOT AGREE TO THIS END-USER LICENSE AGREEMENT (EULA), DO NOT

USE THE DEVICE OR COPY THE SOFTWARE. INSTEAD, PROMPTLY CONTACT
Radiometer Medical ApS FOR INSTRUCTIONS ON RETURN OF THE UNUSED
DEVICE(S) FOR A REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT
LIMITED TO USE ON THE DEVICE, WILL CONSTITUTE YOUR AGREEMENT TO THIS
EULA (OR RATIFICATION OF ANY PREVIOUS CONSENT).
• GRANT OF SOFTWARE LICENSE. This EULA grants you the following license:
• You may use the SOFTWARE only on the DEVICE.
• NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. Radiometer
Medical ApS HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN
THE DEVICE, AND MS HAS RELIED UPON Radiometer Medical ApS TO CONDUCT
SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR
SUCH USE.
• NO WARRANTIES FOR THE SOFTWARE. THE SOFTWARE is provided AS IS and with
all faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCU-
RACY AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO,
THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE
SOFTWARE OR AGAINST INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRAN-
TIES REGARDING THE DEVICE OR THE SOFTWARE, THOSE WARRANTIES DO NOT
ORIGINATE FROM, AND ARE NOT BINDING ON, MS.
• Note on Java Support. The SOFTWARE may contain support for programs written in
Java. Java technology is not fault tolerant and is not designed, manufactured or
intended for use or resale as online control equipment in hazardous environments
requiring fail-safe performance, such as in the operation of nuclear facilities, aircraft
390
ABL90 FLEX: Instructions for use Chapter 16: Legal information
navigation or communication systems, air traffic control, direct life-support

machines, or weapons systems, in which the failure of Java technology could lead
directly to death, personal injury, or severe physical or environmental damage. Sun
Microsystems, Inc. has contractually obligated MS to make this disclaimer.
• No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE
NO LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL
DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE
OF THE SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF
ITS ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN
EXCESS OF U.S. TWO HUNDRED AND FIFTY DOLLARS (USD 250.00).
• Limitations on Reverse Engineering, Decompilation and Disassembly. You may not
reverse engineer, decompile or disassemble the SOFTWARE, except and only to the
extent that such activity is expressly permitted by applicable law notwithstanding
this limitation.
• SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently
transfer rights under this EULA only as part of a permanent sale or transfer of the
Device, and only if the recipient agrees to this EULA. If the SOFTWARE is an
upgrade, any transfer must also include all prior versions of the SOFTWARE.
• EXPORT RESTRICTIONS. You acknowledge that the SOFTWARE is of U.S. origin. You
are to comply with all applicable international and national laws that apply to the
SOFTWARE, including the U.S. Export Administration Regulations, as well as
end-user, end-use and country destination restrictions issued by U.S. and other
governments. For additional information on exporting the SOFTWARE, see
http://www.microsoft.com/exporting/.
391
Chapter 16: Legal information ABL90 FLEX: Instructions for use
392
Index
A unlock.............................................. 149
access profiles analyzer exterior
edit access to menus.......................... 144 clean..................................................56
edit button shortcuts.......................... 144 disinfect............................................. 57
acid-base chart analyzer messages
automatic printing..............................168 troubleshoot....................................... 98
acoustic signals analyzer overview
mute................................................ 152 side and back view................................ 6
set................................................... 152 analyzer status
activity log access................................................. 8
about............................................... 134 screen................................................. 9
add message.....................................134 traffic light colors.................................. 9
filter activities................................... 134 analyzer-specific control ranges
see activities..................................... 134 ensure width of..................................192
troubleshoot messages....................... 134 how to establish................................ 191
activity vs. concentration..........................342 stage 1.............................................192
age groups stage 2.............................................192
set limits.......................................... 160 stage 3.............................................192
alarm sound settings for events anonymous use
default settings..................................207 set up.............................................. 145
alternative presentaion anticoagulants
pH/blood gas.....................................259 recommended and others..................... 17
alternative presentation AQM
electrolytes....................................... 259 automatic QC management................... 63
metabolites....................................... 261 archived data logs
oximetry parameters.......................... 264 create space by moving...................... 203
ampoule-based QC measurements export.............................................. 203
do..................................................... 71 archives
get good.............................................68 import.............................................. 203
set up mode......................................156 audit trail................................................. 31
solutions for........................................68 automatic archiving
status................................................ 72 default settings..................................214
ampoule-based QC results set up.............................................. 202
find....................................................73 automatic backup
messages........................................... 73 default setting................................... 214
symbols............................................. 73 automatic data request
analysis modes set up.............................................. 199
capillary........................................... 157 automatic data transmission
syringe............................................. 153 set up.............................................. 199
analysis setup automatic printing
default settings..................................207 default settings..................................214
analyzer set up.............................................. 200
dispose.............................................. 58 automatic quality management
flush.................................................. 95 overview............................................ 64
front view.............................................5
installation number............................ 135
lock..................................................149 B
move with charged battery..................140 back button
move without battery......................... 140 function..............................................13
recycle............................................... 58 backup
serial number.................................... 135 destinations...................................... 204
393
Index ABL90 FLEX: Instructions for use
manual.............................................204 trends................................................ 91
schedule automatic............................ 204 understanding..................................... 90
barcode calibration schedule
scan.................................................. 12 default settings..................................211
barcode reader calibration solutions................................. 344
connect.............................................. 61 calibration verification
barcodes about................................................. 74
scan data from.................................. 151 frequency........................................... 74
barometric pressure set up mode......................................156
set................................................... 153 using temperature corrected results....... 79
battery calibration-verification ampoule
installation..........................................57 prepare for use................................... 75
service of........................................... 57 calibration-verification measurement
to charge............................................57 do..................................................... 76
battery power........................................... 11 find result...........................................77
bias....................................................... 219 symbols on results............................... 78
bilirubin results calibration-verification results
calculation........................................ 367 temperature correct Range+ QUALICHECK
built-in QC measurement measurements.................................... 78
status................................................ 66 calibrations
built-in QC measurements automatic and manual..........................85
about................................................. 65 corrective actions for scheduled........... 177
frequency.................................... 65, 182 identification in Calibration log screen.....89
request unscheduled............................ 66 identification in screens........................ 85
built-in QC results capillary modes
find....................................................66 edit.................................................. 157
see messages..................................... 67 select a specific report layout.............. 156
symbols............................................. 66 cautions
troubleshoot messages......................... 67 definition..............................................3
general.............................................. 17
cCa2+
performance test results..................... 226
C
traceability........................................308
calculated...............................................314
cCl-
calibration
definition.......................................... 344
traceability........................................308
edit schedule.....................................175
centralized user management
find results......................................... 89
set up.............................................. 147
frequency.................................... 85, 344
cGlu
frequency (details)............................. 175
request an unscheduled from Analyzer
traceability........................................309
status screen...................................... 87
cGlu results
request an unscheduled from menu........87
effect of pO2 values........................... 229
status................................................ 86
check buttons
symbols that show the status................ 86
deselect............................................. 13
calibration equation
select.................................................13
about............................................... 345
cK+
derivation......................................... 345
calibration frequency
traceability........................................308
after sensor cassette replacement..........40
cLac
calibration log
status................................................ 91
traceability........................................309
calibration results
cleaning
filter data........................................... 90
analyzer exterior................................. 56
messages on.......................................90
touch screen....................................... 56
394
ABL90 FLEX: Instructions for use Index
when is it necessary?........................... 52 defaults............................................ 315

close button definitions of acid-base....................... 316
function..............................................13 definitions of electrolyte......................319
cNa+ definitions of oximetry........................ 317
performance test results..................... 225 definitions of oxygen.......................... 317
traceability........................................308 enable estimation.............................. 171
coefficient of variation (CV %)...................220 estimated......................................... 314
communication setup disinfecting
default settings..................................212 analyzer exterior................................. 57
concentration vs. activity..........................342 touch screen....................................... 57
confidence intervals................................. 220 when is it necessary?........................... 56
consumables document
order................................................. 35 about this.............................................2
replacement intervals........................... 35 documents................................................. 3
see an overview.................................... 7 drift
see details............................................7 definition.......................................... 347
control ranges
about analyzer-specific....................... 191
change to analyzer-specific control E
ranges..............................................192
electrolyte results
converting to other units.......................... 334
calculation........................................ 351
corrective actions
electrolyte sensors
for errors in built-in QC.......................185
calculation of sensitivity...................... 351
for errors in QC results....................... 184
construction...................................... 348
for overdue calibrations...................... 177
measuring principle............................ 349
for overdue scheduled QC measure-
ments.............................................. 185 status and sensitivity calibrations......... 351
for pending operator activities............. 196 environmental specifications..................... 378
system messages...............................150 equations
critical limit notification.............................. 33 derived oxygen parameters................. 323
critical limits Equations
about............................................... 160 derived acid-based parameters............ 320
set up.............................................. 160 derived electrolyte parameters.............322
ctBil derived oximetry parameters............... 332
performance test results..................... 235 ODC.................................................335
sensitivity for MCHC variations.............257 units and symbols used...................... 320
ctHb external systems
performance test results..................... 230 interfacing with..................................372
traceability........................................309 external test results
comparison studies............................ 287
D
data
F
backup destinations........................... 204 FCOHb
enter................................................. 13 performance test results..................... 232
restore............................................. 204 traceability - 100 %........................... 310
scan to enter.....................................151 traceability - normal value...................309
data logs feedback messages..................................... 9
about................................................. 15 FHbF
automatic archiving............................202 performance test results..................... 235
export.............................................. 202 limitation of use.................................... 2
format of exported............................. 202 traceability........................................310
overview............................................ 15 FHHb
decimal separator....................................152 performance test results..................... 234
derived parameters filtering
395
QC results.......................................... 81 analyzer............................................... 1
activities...........................................134 interference
calibration results................................ 90 electrolytes....................................... 243
patient results..................................... 30 HbF/HbA...........................................365
fluid transport system metabolites....................................... 247
disinfect............................................. 57 oximetry parameters.......................... 251
flush.................................................. 95 pH/blood gas.....................................242
overview...........................................342 tests................................................ 242
FMetHb intervention required mode
performance test results..................... 233 to get out of........................................93
traceability........................................310
FO2Hb
performance test results..................... 232 K
keyboard
connect non-USB external keyboard....... 60
G connect USB keyboard..........................60
glossary keyboard layout...................................... 152
QC terms.......................................... 177
guided troubleshooting
about................................................. 93 L
language
change............................................. 152
H default setting................................... 207
hazards..................................................... 3 latest patient result
HbF corrections find....................................................28
enable.............................................. 171 limitations of use........................................ 2
Hct linearity studies
traceability........................................310 graphical presentation of results.......... 237
linearity study
introduction...................................... 236
I liquid sensor adjustment
request.............................................. 98
icons
LIS/HIS connection
explanations......................................383
set up.............................................. 198
inlet clip
log
put on................................................ 58
all measurement activities...................153
remove.............................................. 60
log on......................................................12
when is it necessary?........................... 58
logoff time
inlet connector gasket
set................................................... 147
replace...............................................48
logon
inlet gasket
select logon procedure........................144
clean..................................................52
long-term shutdown
inlet gasket holder
to do................................................ 138
replace...............................................43
when to do........................................137
inlet module
clean..................................................53
replace...............................................50
inlet probe M
replace...............................................44 mandatory and operator-defined activities
input parameters about............................................... 194
acceptable values...............................313 manual calibration
defaults............................................ 315 tHb calibration.....................................85
definitions.........................................313 max sample age......................................163
intended use maximum sample age
396
set................................................... 162 operator action needed mode

measured parameters get out of........................................... 93
defaults............................................ 315 operator activities
definitions.........................................217 delete...............................................196
measurement activities operator activity
log all...............................................153 set up.............................................. 196
measurement mode operator requirements................................. 2
remove.............................................155 operators
select a default.................................. 155 add.................................................. 145
measurement principle.............................360 default............................................. 145
measurement principles remove.............................................146
potentiometric................................... 349 operators and profiles
measurement process.............................. 344 default settings..................................206
measurement units optical system
default settings..................................209 calibration.........................................365
measurements and tests construction...................................... 362
total number of..................................150 measuring principle............................ 362
measuring principles ordering information
general introduction........................... 341 power-supply cords............................ 388
menu structure......................................... 14 sensor cassette..................................385
messages solution pack.....................................385
ampoule-based QC results.................... 73 spare parts and accessories.................385
calibration results................................ 90 other activities
patient results..................................... 30 schedule........................................... 195
shown on the analyzer screen..............149 set up corrective action.......................195
types................................................... 9 out-of-range results
metabolite results suppress...........................................170
calculation........................................ 359 oximetry parameters
metabolite sensors sensitivity calibration............................85
calculation of sensitivity...................... 359 oximetry results
construction...................................... 358 calculation........................................ 367
measuring principle............................ 360
zero current...................................... 358
miscellaneous setup P
default settings..................................213
parameter
mode
enable/disable................................... 169
set up ampoule QC.............................156
remove from a patient result................. 31
set up calibration verification............... 156
symbols............................................313
set up proficiency test........................ 158
types................................................313
mouse
parameter bar
connect non-USB mouse.......................60
hide................................................. 169
connect USB mouse............................. 60
show................................................ 169
my results
parameter tab colors................................... 8
find....................................................28
parameters
N default settings..................................209
network edit offset/slope.................................174
connect analyzer to..............................61 input for derived electrolyte.................319
note fields lock/unlock....................................... 149
create standard texts......................... 197 repress.............................................170
delete standard texts..........................198 set up measurement units...................170
edit standard texts............................. 197 suppress out-of-range results.............. 170
patents.................................................. 389
O patient data
offset automatic requests............................ 199
limits for offset value..........................173
397
from LIS/HIS or AQURE/RADIANCE pCO2 sensor

systems............................................199 calculation of sensitivity...................... 354
request automatically from LIS/HIS calibration.........................................354
system............................................... 27 construction...................................... 352
request using patient lookup).............. 199 performance characteristics
request via patient lookup.....................27 bias................................................. 219
patient identification coefficient of variation........................ 220
change report layout in.........................27 confidence intervals............................220
edit data after measurement................. 28 overview...........................................218
screen................................................26 repeatability......................................219
patient lookup reproducibility................................... 219
enable.............................................. 199 test conditions................................... 221
patient profile total analytical error........................... 220
add.................................................. 148 uncertainty....................................... 218
delete...............................................148 performance test results
edit..................................................148 cCa2+.............................................. 226
find.................................................. 148 cCl–................................................. 226
see data saved.................................. 148 cGlu................................................. 227
patient profiles log...................................148 cK+................................................. 225
patient report layout cLac................................................. 229
edit.................................................. 167 cNa+................................................225
patient report layouts ctHb.................................................230
about............................................... 163 FCOHb..............................................232
create.............................................. 163 FHHb................................................234
create extra items for layouts.............. 166 FMetHb.............................................233
select default.....................................166 FO2Hb..............................................232
patient results pH................................................... 223
acid-base chart................................... 30 pO2................................................. 224
add a note.......................................... 31 rounding rules................................... 223
approval and rejection...................32, 169 sO2..................................................231
approve..............................................32 pH
audit trail........................................... 31 performance characteristics.................223
change a layout for............................ 165 traceability........................................307
enable approval/rejection....................169 pH results
filter data........................................... 30 calculation........................................ 351
find....................................................28 pH sensor
reject................................................. 32 calculation of sensitivity...................... 351
remove a parameter............................ 31 construction...................................... 348
see messages..................................... 30 measuring principle............................ 349
show a parameter................................32 status and sensitivity calibrations......... 351
symbols............................................. 28 pO2
trends................................................ 31 calibration overview........................... 356
patient results log measuring principle............................ 355
status................................................ 29 performance test results..................... 224
patient samples traceability........................................308
storage recommendations..................... 19 pO2 results
patient/sample mix-up calculation........................................ 357
reduce risk.................................. 20, 161 fix decimals in................................... 170
pCO2 power-supply cords
measuring principle............................ 353 product codes....................................388
performance test results 223–227, 229–234 precision
traceability........................................308 within ranges.................................... 372
pCO2 results printed data
calculation........................................ 355 create a heading................................ 151
fix decimals in................................... 170 printer
398
edit name......................................... 201 data saved for registered non-

install............................................... 201 Radiometer....................................... 180
printer paper data saved in registered Radiometer.....178
protection of printed data..................... 42 enable use of fixed standard deviations.192
replace...............................................42 why is registration necessary?............. 178
printer setup QC statistics
default settings..................................214 automatically print when lot numbers
product codes change............................................. 186
sampling devices............................... 387 find....................................................79
product specifications...............................376 print.................................................. 79
proficiency test set statistical factor............................ 186
set up mode......................................158 QC terms............................................... 177
proficiency test modes quality control
definition.......................................... 157 management.......................................63
pump calibration terms............................................... 177
request.............................................. 98
R
Q RADIANCE
QA portal access from analyzer.......................... 200
set up connection...............................200 RADIANCE connection
QC ID data set up.............................................. 198
edit....................................................72 Radiometer QC ampoule
QC management prepare for use................................... 69
automatic........................................... 63 range
by operators....................................... 67 of indication...................................... 161
QC measurement reference range for neo ctBil............... 159
edit schedule for ampoule-based.......... 181 ranges and critical limits
QC measurements about..........................................29, 158
after replacement.............................. 184 reference
edit schedule for built-in..................... 182 getting to know the analyzer............. 3, 61
schedule ampoule-based.....................181 reference electrode
set up the temperature field................ 180 construction...................................... 348
status................................................ 63 purpose............................................ 347
status symbols.................................... 63 reference methods/materials.................... 222
QC plot reference ranges
find....................................................81 about............................................... 159
QC plots...................................................80 set up.............................................. 160
QC products references
ordering information...........................386 introduction.................................... 3, 61
product codes....................................386 patient sample analysis chapter............. 34
QC results performance characteristics chapter..... 311
filter.................................................. 81 principles of operation chapter............. 369
QC schedule setup chapter.................................... 215
link to the calibration schedule.............176 regional settings
QC solution select............................................... 152
manually change control ranges...........193 repeatability........................................... 219
register a non-Radiometer...................179 replacement intervals
register a Radiometer......................... 178 recommended..................................... 35
QC solutions replacement setups
about registration.............................. 178 default settings..................................211
ampoule-based QC.............................. 68 replacement warnings
analyze in other modes........................ 82 set up.............................................. 197
report layout
edit.................................................. 167
399
reportable ranges can it be used again?........................... 41

about............................................... 161 effect of replacement on analysis time.... 40
set up.............................................. 161 export status logs................................ 41
reproducibility......................................... 219 intended use..................................... 382
restart print status logs.................................. 41
after a temporary shutdown................ 140 product codes....................................385
after long-term shutdown................... 141 replace...............................................39
restoring data specifications.....................................382
from backup......................................204 status of.............................................39
to Radiometer default settings............. 205 sensor response stability
result messages metabolite sensors............................. 359
troubleshoot............................ 30, 74, 90 pCO2 sensor.............................. 352, 355
RiLiBÄK rules pH and electrolytes sensor........... 352, 355
add.................................................. 189 service...................................................134
apply................................................190 setup
edit..................................................190 load................................................. 205
remove.............................................191 menu structure..................................143
rinse print setups.......................................144
process.............................................344 restore Radiometer default settings...... 205
request.............................................. 98 save.................................................205
setups
with no default setting........................ 214
S shutdown
do a long-term.................................. 138
sample
temporary.........................................137
mix on analyzer...................................19
slope
pre-register........................................ 20
limits for slope value.......................... 173
pre-registration............................ 20, 161
slope and offset
to get a good...................................... 18
apply corrections to QC results............ 185
what is a good sample..........................18
sO2
sample age evaluation
about............................................... 162
sO2 = 0%
sample analysis
traceability........................................309
capillary tube...................................... 22
sO2 = 100 %
syringes............................................. 21
traceablity........................................ 309
test tube............................................ 24
software version......................................135
sample counter
solution pack
reset................................................ 150
can it be used again?........................... 38
screen explanation............................. 150
export status logs................................ 39
see.................................................. 150
print status logs.................................. 39
sample pre-registration
product codes....................................385
interpret barcodes as..........................162
release manually................................. 38
set up.............................................. 162
replace...............................................36
sample type............................................319
specifications.....................................380
sampling device
status of.............................................36
ordering information...........................387
use of...............................................380
product codes....................................387
specifications
saving changes......................................... 13
environmental................................... 378
screen saver
measured blood parameters................ 371
enable.............................................. 151
power-supply cords............................ 380
sensitivity
product............................................ 376
definition.......................................... 345
start screen
sensor
about...................................................9
general construction........................... 341
quick access......................................... 9
sensor cassette
statistical factor...................................... 186
400
status messages in the Analyzer status

definition.......................................... 347 screen.......................................... 11, 94
storing the analyzer................................. 140 troubleshooting
symbols when is it necessary?........................... 93
ampoule-based QC results.................... 73 troubleshooting modes
built-in QC results................................66 causes............................................... 93
explanation....................................... 383 troubleshooting needed mode
on calibration-verification results........... 78 get out of........................................... 93
syringe modes tubing refill
create new........................................154 request.............................................. 98
edit.................................................. 153
select a specific report layout.............. 156
system checks.......................................... 64 U
system messages uncertainty
set up corrective actions..................... 150 convert to another confidence level...... 219
performance characteristics.................218
T units
temperature set up.............................................. 170
automatically change unit................... 167 user-defined corrections
temporary shutdown apply to QC results.............................185
to do................................................ 137 edit..................................................174
when to do........................................137 offset and slope................................. 172
test conditions........................................ 221 user-defined patient data items
text default settings..................................212
enter................................................. 13
tHb calibration
do..................................................... 87 W
thousands separator................................ 152 warnings
time and data formats..............................152 definition..............................................3
time and date general.............................................. 17
set................................................... 151 WDC
total analytical error................................ 220 about................................................. 81
touch screen export file...........................................82
clean..................................................56 Westgard rules
disinfect............................................. 57 description and corrective action.......... 187
trends disable/enable................................... 189
calibration results................................ 91 line descriptions.................................186
in patient results................................. 31 set up and enable.............................. 188
QC results.......................................... 81 types................................................186
troubleshoot
401
402
If you have any questions or need assistance, please contact your local Radiometer representa-
tive.
Radiometer representative:
Code number: 996-189

Version: 201602A
Radiometer Medical ApS

Åkandevej 21
2700 Brønshøj
Denmark
http://www.radiometer.com
© 2016 Radiometer Medical ApS. All rights reserved.

ABL90 Flex Instruction Manual

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ABL90 FLEX

Instructions for use

2. Getting to know the analyzer

Overview of the analyzer.................................................................................. 5

3. Patient sample analysis

General warnings and cautions.................................................................................. 17

4. Replacements and maintenance

General warnings and cautions.................................................................................. 35

Overview of quality control management.................................................................... 63

Calibrations - automatic and manual.......................................................................... 85

Troubleshooting - when is it necessary?...................................................................... 93

8. Shutting down, moving and restarting the analyzer

Setup menu structure.............................................................................................143

To add a new patient profile.................................................................................... 148

Sample age evaluation.................................................................................. 162

To edit the schedule for ampoule-based QC measurements.......................................... 181

To delete standard texts for use in Note fields............................................................ 198

10. Performance characteristics

Measured parameters - definitions............................................................................217

External test results...................................................................................... 269

11. Derived and input parameters

Parameter types.................................................................................................... 313

Electrolyte derived parameters – definitions...............................................................319

Q̇t - equation 32.................................................................................................... 329

̇ 2 - equation 33.................................................................................................. 329

Qx - equation 38.................................................................................................... 331

12. Principles of operation

General construction..................................................................................... 341

Measurement principles - pH and electrolyte sensors......................................... 349

Measurement process............................................................................................. 360

Analyzer specifications.................................................................................. 371

14. Graphical symbols

Explanation of graphical symbols/icons..................................................................... 383

15. Ordering information

Solution Packs - code numbers................................................................................ 385

16. Legal information

Patents and trademarks................................................................................. 389

It is intended for use in a laboratory environment, near patient or point-of-care setting.

These tests are only performed under a physician's order.

In the table below the measured parameters are shown:

pH/blood gas: pH (acidity)

pCO2 (carbon dioxide tension)

pO2 (oxygen tension)

Oximetry: ctHb (total hemoglobin concentration)

sO2 (oxygen saturation)

FO2Hb (fraction of oxyhemoglobin in total hemoglobin)

FCOHb (fraction of carboxyhemoglobin in total hemoglobin)

FHHb (fraction of deoxyhemoglobin in total hemoglobin)

FMetHb (fraction of methemoglobin in total hemoglobin)

FHbF (fraction of fetal hemoglobin)

Electrolytes: cK+ (potassium ion concentration)

cNa+ (sodium ion concentration)

cCa2+ (calcium ion concentration)

cCl– (chloride ion concentration)

Metabolites: cGlu (D-glucose concentration)

cLac (L(+)-lactate concentration)

ctBil* (concentration of total neonatal bilirubin in plasma)

About limitations of use

CAUTION – ctBil results

Operator training requirements