ABL90 FLEX Instructions for Use sw ver 3.3

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... 10 Is the analyzer operating on battery power?... 11

Common tasks... 12 To log on... 12 To scan a barcode... 12 To enter text... 12 To select/deselect a check button...12 To save changes... 12

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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ABL90 FLEX: Instructions for use

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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... 21

Analyzing patient samples... 21 General information for obtaining successful patient sample analyses... 21 To analyze a sample from a syringe...22 To analyze a sample from a capillary tube... 23 To analyze a sample from a test tube... 25 To get calculated values for FShunt and ctO2(a-v̄)... 27

Entering and editing data in the Patient identification screen... 27 The Patient identification screen...27 To change the report layout in the Patient identification screen... 28 To request patient data automatically when connected to a LIS/HIS system...28 To request patient data using Patient lookup...28 To edit data in the Patient identification screen... 29

Patient results... 29 To find a patient result...29 Symbols on patient results... 29 About ranges and critical limits... 30 Status in the Patient results log... 30 To see messages on patient results... 31 To troubleshoot messages on results... 31 To see the acid-base chart for a result... 31

Reviewing and editing patient results... 31 To filter data from the Patient results log...31 To see trends in a patient's results... 32 To see the audit trail on a patient result... 32 To add a note to a patient result ... 32 To remove a parameter from a patient result... 32 To show a parameter in a patient result... 33 Approval and rejection of patient results... 33 To approve a patient result...33 To reject a patient result... 33

Critical limit notification... 34 About Critical limit notification... 34 To enable Critical limit notification... 34 To use Critical limit notification... 34 Pending results log...34 To access the Pending results log... 35 Input fields for the Patient report layout...35 References...35

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ABL90 FLEX: Instructions for use

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Contents

Replacements and maintenance General warnings and cautions... 37 To order products for use with your analyzer... 37 Replacement intervals for consumables and Inlet Connector Gasket...37

Replacements... 38 Solution Pack... 38 To see the Solution Pack status...38 To replace the Solution Pack... 38 To release the Solution Pack manually... 41 Can a Solution Pack be used again?...41 Status logs... 41 To print Solution Pack status logs... 41 To export Solution Pack status logs... 42

Sensor Cassette... 42 To see the Sensor Cassette status... 42 To replace the Sensor Cassette... 42 Calibration frequency after a Sensor Cassette SC90 replacement ...43 Can a Sensor Cassette be used again?...43 Status logs... 43 To print Sensor Cassette status logs... 44 To export Sensor Cassette status logs...44

Thermal printer paper... 44 To replace the thermal printer paper...44 Protection of printed data... 45

Inlet Gasket Holder... 45 To replace the Inlet Gasket Holder...45

Inlet Probe... 47 To replace the Inlet Probe... 47

Inlet Connector Gasket... 50 To replace the Inlet Connector Gasket... 50

Inlet Module... 52 To replace the Inlet Module... 52

Maintenance... 54 Cleaning... 54 Cleaning - when is it necessary?... 54 To clean the inlet gasket... 54 To clean the Inlet Module... 55 To clean the touch screen... 58 To clean the analyzer exterior...58 To clean the QUALICHECK Opener/Adapter...59

Disinfecting... 59 Disinfection - when is it necessary?... 59 To disinfect the touch screen ... 59 To disinfect the analyzer exterior... 60 To disinfect the fluid transport system... 60

Battery... 60 To recharge the analyzer battery...60 To install and service the battery...60

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Disposal... 61 To dispose of the analyzer...61

Inlet Clip... 61 Inlet Clip - when is it necessary to use one?... 61 To put an Inlet Clip on the Inlet Gasket Holder... 61 To remove the Inlet Clip from the Inlet Gasket Holder... 63

Connecting peripherals... 63 To connect a USB external keyboard / mouse... 63 To connect a non-USB (PS/2) external keyboard or mouse... 64 To connect an external barcode reader...64 To connect the analyzer to a network...64 Reference... 64

5.

Quality control Overview of quality control management... 65 To find the status of QC measurements...65 Symbols that show the status of QCs...65

Automatic quality control management... 65 About automatic quality control management... 65 About system checks...66 Overview of automatic quality management... 66

Built-in QC... 67 About built-in QC measurements...67 Built-in QC measurement frequency... 67 To request an unscheduled built-in QC measurement... 68

Built-in QC results... 68 Status of built-in QC measurements... 68 To find a built-in QC result... 68 Symbols on built-in QC results...68 To see messages on built-in QC results... 69 To troubleshoot messages on built-in QC results...69

Quality control management done by operators... 69 Quality control management that can be done by operators...69

Ampoule-based QC measurements... 70 QC solutions for ampoule-based measurements... 70 How to get good ampoule-based QC measurement results... 70 To prepare a Radiometer QC ampoule for use... 71 To do a Radiometer ampoule-based QC measurement from the Analyzer status screen...73 To do an ampoule-based QC measurement from the start screen... 75 To edit QC identification data...77

Ampoule-based QC results... 77 Status of ampoule-based QC measurements...77 To find an ampoule-based QC result... 77 Symbols on ampoule-based QC results... 77 To see messages on ampoule-based QC results...78 To troubleshoot messages on results... 78

Calibration verification...78 About calibration verification... 78 Frequency of calibration verification... 78

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Stage 1 - Analyzing different levels of control solution... 79 To prepare a Radiometer calibration-verification ampoule for use...79 To do a calibration-verification measurement... 80

Stage 2 - Using results to verify reportable ranges... 81 To find a calibration-verification measurement result... 81 Symbols on calibration-verification measurement results...82 To temperature correct calibration-verification results based on Range+ QUALICHECK measurements... 82 To use temperature-corrected calibration-verification results...83 To use corrected QUALICHECK7+ control ranges... 83

Stage 3 - Changing reportable ranges... 84 To change the reportable range of parameters... 84

Reviewing QC statistics... 84 To find and print QC statistics... 84 QC plots... 84 To find a QC plot...85 To filter data from the Quality control log... 85 To see trends in QC results...86

WDC file export...86 About WDC... 86 To export WDC files...86

Analyzing QC solutions in other modes... 86 About analyzing QC solutions in other modes...86 To temperature correct results based on QUALICHECK5+ solutions... 87

6.

Calibration Calibrations - automatic and manual... 89 Identification of calibrations in screens... 89 Manual calibration of the oximetry parameters...89 Frequency of automatic calibrations...89 To find the status of calibrations... 90 Symbols that show the calibration status... 90

Automatic calibrations...91 To request an unscheduled calibration from the Analyzer status screen... 91 To request an unscheduled calibration from the menu... 91

Manual tHb calibrations... 91 To do a tHb calibration...91

Calibration results... 93 To find a calibration result... 93 Identification of calibrations in the Calibration log screen...93 Understanding calibration results... 94 To see messages on a calibration result... 94 To troubleshoot messages on results... 94

Reviewing calibration results... 94 To filter data from the Calibration log...94 To see trends in calibration results... 95 Status in the Calibration log screen... 95

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ABL90 FLEX: Instructions for use

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Troubleshooting Troubleshooting - when is it necessary?... 97 About guided troubleshooting... 97 To get out of Operator Action Needed mode...97 To get out of Troubleshooting needed mode...97 To get out of Intervention Required mode... 97 Troubleshooting modes - causes... 97 To find and troubleshoot messages in the Analyzer status screen... 98 To flush the fluid transport system... 99

Operator actions requested in analyzer messages... 102 To request a tubing refill... 102 To request a liquid sensor adjustment... 102 To request a pump calibration... 102 To request a rinse... 102

Troubleshooting Analyzer messages... 102 To troubleshoot Analyzer messages... 102 Analyzer messages...102

Activity log... 138 About the Activity log... 138 To troubleshoot messages in the Activity log... 138 To see activities in the Activity log... 138 To add a message to the Activity log...138 To filter activities from the Activity log... 139

Analyzer service... 139 For service... 139 To find the installation number (serial number) of the analyzer...139 To find the version of software installed...139

8.

Shutting down, moving and restarting the analyzer Shutdown... 141

Temporary shutdown of the analyzer... 141 When to do a temporary shutdown... 141 To do a temporary shutdown... 141

Long-term shutdown of the analyzer... 141 When to do a long-term shutdown...141 To do a long-term shutdown ... 142

Storing the analyzer...144 To store the analyzer... 144

Moving the analyzer... 144 To move an analyzer that has a charged battery...144 To move an analyzer that does not have a battery... 144

Restarting the analyzer... 145 To restart the analyzer after a temporary shutdown... 145 To restart the analyzer after a long-term shutdown...145

9.

Setup Setup menu structure...147

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To print setups...148

Managing operators... 148 To select the logon procedure... 148 Access profiles...148 To edit an access profile... 148 Anonymous use... 149 To set up anonymous use...149 Default operators... 149 To add an operator... 149 To remove an operator...150 To set a logoff time for all operators... 151 Centralized user management...151 To set up centralized user management... 151

Managing patient profiles... 152 Patient profiles log... 152 To see the data saved in a patient profile...152 To find a patient profile... 152 To edit a patient profile... 152 To add a new patient profile... 152 To delete a patient profile...152

Analyzer operations... 153 To lock the analyzer... 153 To unlock the analyzer... 153 To lock/unlock parameters for measurement...153 To show a message on the analyzer screen...153

Sample counter... 154 To see an overview of measurements and tests done on the analyzer...154 Sample counter... 154 To reset the counters in the User column...154

Analyzer settings... 154 To set up corrective actions on system messages... 154 To enable data to be scanned from barcodes...155 To create a heading for printed data... 155 To enable the screen saver... 155 To set the time and date... 155 To set the acoustic signals... 156 To mute all acoustic signals... 156 To change the screen language... 156 To select a regional setting... 156 To set the barometric pressure...157 To log all measurement activities...157

Analysis setup... 157 Analysis modes... 157 Syringe modes... 157 To edit a syringe mode...157 To create a new syringe mode...158 To remove a measurement mode... 159 To select a default measurement mode... 159 To select a specific patient report layout for an analysis mode... 159 To set up a calibration-verification mode... 160 To set up an ampoule QC mode...160 Capillary modes... 160

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To edit a capillary mode... 160

Ranges and critical limits... 161 About ranges and critical limits... 161 About reference ranges...162 Reference range of measured parameters...162 About critical limits...162 To set the limits for patient age groups... 162 To set up reference ranges and critical limits...163 About reportable ranges...163 To set up reportable ranges... 163 About range of indication... 164

Sample pre-registration... 164 About sample pre-registration...164 To set up sample pre-registration... 164

Sample age evaluation... 164 About sample age evaluation... 164 Maximum sample age...164 To set a maximum sample age...165 Max sample age...165

Patient report layouts... 165 About patient report layouts... 165 To create a patient report layout... 165 To change a patient result layout...167 To create extra items for use in patient report layouts... 168 To select a patient report layout as default... 168 To automatically change the temperature units... 169 To edit a patient report layout...169 To create a patient report layout for FShunt and ctO2(a-v̄)... 170

Patient result settings... 170 To set up automatic printing of acid-base charts... 170 Approval and rejection of patient results... 171 To enable patient result approval/rejection... 171

Parameter settings... 171 To show the parameter bar...171 To hide the parameter bar... 171 To enable/disable a parameter... 171 To set up measuring units for parameters...172 To repress a parameter... 172 To suppress out-of-range results... 172 To fix the number of decimals used in blood-gas results... 172 To enable HbF corrections... 173 To enable the estimation of derived parameters... 173

Editing the slope and offset of a parameter... 174 Operator-defined corrections (offset and slope)... 174 Recommendations about samples to use... 175 Limits for slope and offset values... 175 To edit the offset and slope for a parameter...176

Calibration settings... 177 Details about calibration frequency... 177 To edit the calibration schedule... 177 To link the built-in QC schedule to the calibration schedule... 178

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To set up corrective actions for overdue scheduled calibrations...179

Quality control... 179 Glossary of quality control terms... 179

Registration of QC solutions... 180 Why is it necessary to register QC solutions?... 180 About registration of QC solutions... 180 To register a Radiometer QC solution for ampoule-based QC measurements...180 Data saved during registration of Radiometer QC solutions... 180 To register a non-Radiometer QC solution...181 Data saved during registration of non-Radiometer QC solutions... 182

Quality control solutions... 182 To set up the temperature field for QC measurements... 182

Scheduled QC measurements... 183 To schedule ampoule-based QC measurements... 183 To edit the schedule for ampoule-based QC measurements... 183 Built-in QC measurement frequency... 184 To edit the schedule for built-in QC measurements... 184 To request ampoule-based QC measurements after replacements... 185

Corrective actions on QC results... 186 To set up corrective action for errors in QC results... 186 To set up corrective actions for overdue scheduled QC measurements... 186 To apply operator-defined corrections to QC results... 187 To set up corrective action for errors in built-in QC measurements... 187

QC statistics... 187 To set up automatic print of built-in QC statistics... 187 Statistical factor...187 To set the statistical factor... 188

Westgard Rules... 188 About Westgard Rules...188 Types of Westgard Rule ...188 Description of the lines used in Westgard rule illustrations... 188 Westgard rules and corrective actions... 188 To set up and enable Westgard Rules... 190 To disable/enable Westgard rules... 190

RiLiBÄK rules... 191 About RiLiBÄK rules...191 To add a new RiLiBÄK rule... 191 To apply all RiLiBÄK rules... 192 To edit a RiLiBÄK rule... 192 To remove a RiLiBÄK rule... 192

Analyzer-specific control ranges... 192 About analyzer-specific control ranges... 192 How to establish analyzer-specific control ranges... 193 Stage 1: To do 20 ampoule-based QC measurements...193 Stage 2: To enable the use of fixed standard deviations... 193 Stage 3: To use the analyzer to change control ranges to analyzer-specific control ranges...194 To manually change control ranges to analyzer-specific control ranges... 194

Maintenance setup... 196 About mandatory and operator-defined activities...196

Mandatory maintenance activities... 196 Other activities... 196

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To schedule other activities...196 To set up corrective action for overdue Other activities...196

Operator-defined activities... 197 Operator activities...197 To set up an operator activity... 197 To set up corrective action for pending operator activities... 198 To delete an operator activity...198

Maintenance planning...198 To plan maintenance activities... 198

Replacement warnings... 198 To set up replacement warnings... 198

Note fields... 199 To create standard texts for use in Note fields... 199 To edit standard texts for use in Note fields... 199 To delete standard texts for use in Note fields... 199

Communications... 199 Data security...199 Live Connect... 200 To set up a LIS/HIS connection... 200 To set up a AQURE/RADIANCE connection... 201 Patient data from a LIS/HIS or AQURE/RADIANCE system... 201 To set up automatic requests for patient data... 201 To set up automatic transmission of data to a system... 202 To enable manual patient data requests using Patient lookup... 202 To access the RADIANCE system from the analyzer...202 To set up a QA Portal connection... 202

Printers... 203 To set up automatic printing... 203 To install an external printer for the analyzer... 203 To edit the name of a printer... 203

Data logs and archives... 204 About data logs and archived data logs... 204 To set up automatic archiving... 204 File format of exported data logs and archived data logs... 204 To export data logs...204 To export data from Archived data logs... 205 To create disc space by exporting and deleting archives... 205 To import archived data logs...205

Data backup and restoration... 206 Backup... 206 Destinations for backup data... 206 To schedule automatic backups... 206 To do a manual backup... 206 To restore data from a backup... 207

Saving and loading setups... 207 To save the setup...207 To load a setup... 207 To restore Radiometer default settings... 208

Radiometer default settings... 208 Operators and profiles - default settings...208 Alarm sound (acoustic signal) settings for events - default settings...209

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Language - default setting...209 Analysis setup – default settings... 209 Parameters - default settings... 211 Measurement units - default settings... 212 Calibration schedule - default settings...213 Quality control setups - default settings... 213 Replacement setups - default settings...213 Communication setup - default settings... 214 User-defined patient data items - default settings...214 Corrective actions – default settings... 215 Miscellaneous setup - default settings... 215 Printer setup - default settings...216 Automatic printing - default settings... 216 Automatic archiving - default settings... 216 Automatic backup - default setting... 216 Setups with no default settings... 217 References... 217

10.

Performance characteristics Measured parameters – definitions... 219

About performance characteristics... 219 Overview of performance characteristics... 219 Uncertainty in performance characteristics... 220 To convert an uncertainty at a 68 % confidence level... 220 Bias... 221 Repeatability and reproducibility... 221 Coefficient of variation (CV %)...222 Confidence intervals... 222 Total analytical error...222

About performance tests...223 Test conditions...223 Reference methods/materials... 224

Performance test results... 225 Rounding rules... 225 pH performance test results... 225 pCO2 performance test results... 226 pO2 performance test results... 226 cK+ performance test results... 227 cNa+ performance test results... 227 cCl– performance test results...228 cCa2+ performance test results... 229 cGlu performance test results... 229 pO2 levels - how they affect cGlu results... 231 cLac performance test results... 231 ctHb performance test results... 232 sO2 performance test results...233 FO2Hb performance test results... 234 FCOHb performance test results...235 FMetHb performance test results...235 FHHb performance test results...236 FHbF performance test results... 237

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ctBil performance test results ... 238 ctBil external test results... 238

Interference test results... 240 Interference tests... 240 pH/blood gas...240 Electrolytes... 241 Metabolites... 243 Oximetry parameters...246 ctBil sensitivity for MCHC variations... 253

Traceability... 254 Traceability to the primary standards at Radiometer...254 pH traceability... 254 pCO2 and pO2 traceability...255 cK+ and cNa+ traceability... 255 cCa2+ traceability... 255 cCl– traceability... 256 cGlu traceability...256 cLac traceability...256 ctHb traceability...256 Saturation – sO2 = 100 % – traceability... 256 Saturation – sO2 = 0 % – traceability... 256 FCOHb – normal value - traceability...257 FCOHb – 100 % - traceability... 257 FMetHb traceability... 257 FHbF traceability... 257 Hct traceability... 257 ctBil traceability... 258 References... 258

11.

Derived and input parameters Parameter types... 261 Parameter symbols...261 Input parameters – definitions and acceptable values... 261 Derived parameters...262 Default values of parameters... 263

Definitions of derived parameters... 264 Acid-base derived parameters – definitions...264 Oximetry derived parameters – definitions... 265 Oxygen derived parameters - definitions... 265 Electrolyte derived parameters – definitions...267 Data necessary to derive electrolyte parameters... 267

Calculation of derived parameters... 267 Sample type...267 Units and symbols used in equations... 268

Equations... 268 Equations for acid-base parameters... 268 pH(T) - equation 1... 268 cH+(T) - equation 2...268 pCO2(T) - equation 3... 268 cHCO3–(P) - equation 4...269 cBase(B) - equation 5...269

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cBase(B,ox) - equation 6...269 cBase(Ecf) - equation 7... 269 cBase(Ecf,ox) - equation 8... 269 cHCO3–(P,st) - equation 9... 269 ctCO2(P) - equation 10... 270 ctCO2(B) - equation 11... 270 pH(st) - equation 12...270

Equations for electrolyte parameters... 270 Anion Gap, K+ equation 43... 270 Anion Gap - equation 44... 270 cCa2+(7.4) - equation 45... 270 Equations 46 and 47...271 mOsm - equation 48... 271

Equations for oxygen parameters... 271 pO2(T) - equation 14... 271 pO2(A) - equation 15... 272 pO2(A,T) - equation 16... 272 pO2(a)/FO2(I) - equation 17... 272 pO2(a,T)/ FO2(I) - equation 18... 272 p50 - equation 19... 272 p50(T) - equation 20... 273 p50(st) - equation 21... 273 pO2(A-a) - equation 22... 273 pO2(A-a,T) - equation 23... 274 pO2(a/A) - equation 24... 274 pO2(a/A,T) - equation 25... 274 pO2(x) or px - equation 26... 274 pO2(x,T) - equation 50... 274 ctO2 - equation 27... 275 ctO2(a-v̄) - equation 28... 275 BO2 - equation 29... 276 ctO2(x) or cx - equation 30... 276 ḊO2 - equation 31... 276 Q̇t - equation 32... 276 VO ̇ 2 - equation 33... 277 FShunt - equation 34...277 FShunt(T) - equation 35... 277 RI - equation 36... 278 RI(T) - equation 37... 278 Qx - equation 38... 279 V(B) - equation 42... 279 VCO2/V(dry air) - equation 51... 279 VO2/V(dry air) - equation 52... 280

Equations for oximetry parameters... 280 FHHb - equation 41... 280 FO2Hb - equation 40...280 sO2 - equation 39...280 Hct - equation 13... 280 FHbF - equation 49... 281 Converting results to other units ... 281

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Oxyhemoglobin dissociation curve...282 ODC equations... 282 The ODC reference position... 283 The ODC displacement...283 The actual ODC position...284 To determine the actual displacement... 285 Coordinates on the ODC...286 References... 287

12.

Principles of operation General construction... 289 Sensors... 289

General measurement principles... 289 Introduction... 289 Activity vs. concentration... 290 Fluid transport system... 290 Measurement process... 292 Rinse process... 292

Calibration... 292 Definition... 292 Frequency...292 Calibration solutions... 292

The calibration equation... 293 About the calibration equation... 293 Plotting a calibration line... 293

Sensitivity, status and drift... 293 Sensitivity...293 Status... 295 Drift... 295

Reference electrode...295 Background information - reference electrode...295 Purpose... 295 Fixed potential...295 Use ... 296

Construction - reference electrode... 296 Construction...296

pH and electrolyte sensors... 296 Construction - pH and electrolyte sensors... 296 Construction...296

Measurement principles - pH and electrolyte sensors... 297 Potentiometric measurement principle... 297 Electrode chain... 297 Electrode chain potential... 298 Derived potential... 298 Ion-sensitive membrane... 298 Nernst equation... 298 Activity and concentration... 299

Calibration - pH and electrolyte sensors... 299 Calibrations of pH and electrolyte sensors... 299 Calculation of pH and electrolytes sensitivity...299

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Measurement - pH and electrolyte sensors... 299 Calculation of pH and electrolyte values... 299 Sensor response stability... 300

pCO2 sensor... 300 Construction - pCO2 sensor... 300 Construction...300

Measurement principle - pCO2 sensor... 301 Electrode chain... 301 Electrode chain potential... 301 Measurement process in the pCO2 sensor... 301

Calibration - pCO2 sensor...302 Calibrations of the pCO2 sensor ...302 Calibration levels... 302 Calculation of pCO2 sensitivity... 302

Measurement - pCO2 sensor...303 Calculation of pCO2 values... 303 Sensor response stability... 303

pO2 sensor... 303 Measurement principle - pO2 sensor... 303 Optical system for pO2...303 Measurement sequence... 304 Calculations... 304

Calibration - pO2 sensor... 304 Overview of pO2 calibrations...304 Sensitivity...304 Status... 305

Measurement - pO2 sensor...305 Calculation of pO2 values... 305

Glu and Lac sensors... 306 Construction - Glu and Lac sensors... 306 Construction - Glu and Lac sensors...306 Zero current - Glu and Lac sensors... 306

Calibration - Glu and Lac sensors... 307 Calculation of sensitivity – Glu and Lac sensors... 307

Measurement - Glu and Lac sensors... 307 Calculation of Glu and Lac values... 307 Sensor response stability of the glucose and lactate sensors... 307

Measurement principle - Glu and Lac sensors... 308 Amperometric measurement principle for Glu and Lac sensors... 308 Electrode chain – Glu and Lac sensors...308 Measurement process – Glu and Lac... 308

ctHb and derivates... 309 Description of the optical system... 309 Measured parameters... 309 Construction...310 Measurement cycle...310 Lambert-Beer's law... 311 Absorbance... 311 Total absorbance...311 Continuous spectrum...312 Spectrum examples...312

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Determining concentrations... 312 Matrix of constants...313

Calibration of the optical system... 313 Calibration materials... 313 Zero point... 313 Cuvette path length...313

Correcting for interferences...314 HbF versus HbA... 314 Deviation of results... 314 Detecting HbF...314 Correcting for HbF...315 Repressing spectra... 315 Residual spectrum...315

Measurement and corrections... 315 Calculation of the values of the oximetry parameters... 315 Bilirubin...316 Restrictions ... 316 Corrections for ctHb... 317 Corrections for ctBil...317 References... 317

13.

Specifications Analyzer specifications... 319 Ranges of indication and reportable ranges...319 Measurement precision within specified ranges...320 Product specifications... 325 Environmental specifications...327 Power-supply cords... 328

Consumables specifications... 329 Solution Pack... 329 Function of the Solution Pack...329 Solution Pack specifications... 329

Sensor Cassette... 330 Function of the Sensor Cassette... 330 Sensor Cassette specifications... 330

14.

Graphical symbols Explanation of graphical symbols/icons... 333

15.

Ordering information Solution Packs – code numbers... 337 Sensor Cassettes – code numbers... 337 Spare parts and accessories - code numbers...337 Quality control products – code numbers...338 Recommended Radiometer sampling devices - code numbers...339 Power-supply cords - code numbers... 340

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Contents

Dialysis fluids - for non-clinical purposes About dialysis fluids...341 Purpose of the dialysis fluids measurement mode... 341 Warnings about analyzing dialysis fluid samples ... 341 To make sure dialysis fluid analyses do not affect analyzer performance... 342 To calculate the offset and slope corrections for dialysis fluid parameters... 342 To enter new offset and slope corrections for dialysis fluid parameters...343 To create a dialysis fluid mode... 343 To analyze a dialysis fluid sample... 344 To find a dialysis fluid analysis result... 345

17.

Legal information Patents and trademarks... 347 Patents... 347 Trademarks... 347

Legal notices... 347 System performance... 347 Third-party software and trademarks... 347 Warranties and disclaimer... 347 Confidentiality... 348 Changes... 348 End-user license agreement with Microsoft... 348

Index

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1

Introduction Intended use

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. The ABL90 FLEX analyzer can be connected to the RADIANCE system. The RADIANCE system enables communication between the RADIANCE server and the ABL90 FLEX analyzer to allow remote data entry and analyzer access. These tests are only performed under a physician's order. 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) ctBil (concentration of total bilirubin in plasma)

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)

1