ABL90 FLEX Instructions for Use sw ver 3.4

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... 7 To see details about installed consumables...8

Is the analyzer ready for use?... 8 Three important conditions... 8 Parameter tab colors...9 To access the Analyzer status screen...9 The Analyzer status screen... 10 Analyzer status - Traffic light colors... 10 Messages...10 To find and troubleshoot messages in the Analyzer status screen... 11 Is the analyzer operating on battery power?... 12

Common tasks... 13 To log on... 13 To scan a barcode... 13 To enter text... 13 To select/deselect a check button...14 To save changes... 14

Menu... 15 Menu structure... 15

Data logs... 16 About data logs... 16 Overview of data logs...16 To access data logs... 16

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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... 20

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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4.

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... 43 To export Sensor Cassette status logs...44

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

Inlet Module... 45 To replace the Inlet Module... 45

Inlet Gasket Holder... 46 To replace the Inlet Gasket Holder...46

Inlet Probe... 48 To replace the Inlet Probe... 48

Inlet Connector Gasket... 51 To replace the Inlet Connector Gasket... 51

Maintenance... 53 Cleaning... 53 Cleaning - when is it necessary?... 53 To clean the inlet gasket... 53 To clean the Inlet Module... 54 To clean the touch screen... 58 To clean the analyzer exterior...58 To clean the QUALICHECK Opener/Adapter...58

Disinfecting... 59 Disinfection - when is it necessary?... 59 To disinfect the touch screen ... 59 To disinfect the analyzer exterior... 59 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... 60 To dispose of the analyzer...60

Inlet Clip... 60 Inlet Clip - when is it necessary to use one?... 60 To put an Inlet Clip on the Inlet Gasket Holder... 60 To remove the Inlet Clip from the Inlet Gasket Holder... 61

Connecting peripherals... 62 To connect a USB external keyboard / mouse... 62 To connect a non-USB (PS/2) external keyboard or mouse... 62 To connect an external barcode reader...62 To connect the analyzer to a network...63 Reference... 63

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...72 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... 82 To find a calibration-verification measurement result... 82 Symbols on calibration-verification measurement results...82 To temperature correct calibration-verification results based on Range+ QUALICHECK measurements... 83 To use temperature-corrected calibration-verification results...83 To temperature correct QUALICHECK7+ pH, pO2 and pCO2 control ranges ... 83 To use corrected QUALICHECK7+ control ranges... 85 To temperature correct pH, pCO2 and pO2 results based on QUALICHECK7+ material...85

Stage 3 - Changing reportable ranges... 86 To change the reportable range of parameters... 86

Reviewing QC statistics... 86 To find and print QC statistics... 86 QC plots... 86 To find a QC plot...87 To filter data from the Quality control log... 87 To see trends in QC results...88

WDC file export...88 About WDC... 88 To export WDC files...88

Analyzing QC solutions in other modes... 88 About analyzing QC solutions in other modes...88 To temperature correct results based on QUALICHECK5+ solutions... 89

6.

Calibration Overview of calibrations...91 Frequency of automatic calibrations...91 To find the status of calibrations... 92 Symbols that show the calibration status... 92

Automatic calibrations...92 To request an unscheduled calibration from the Analyzer status screen... 92 To request an unscheduled calibration from the menu... 92

Manual tHb calibrations... 93 To do a tHb calibration...93

Calibration results... 95 To find a calibration result... 95 Identification of calibrations in the Calibration log screen...95 Understanding calibration results... 95 To see messages on a calibration result... 96 To troubleshoot messages on results... 96

Reviewing calibration results... 96 To filter data from the Calibration log...96 To see trends in calibration results... 96 Status in the Calibration log screen... 97

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Troubleshooting Troubleshooting - when is it necessary?... 99 About guided troubleshooting... 99 To get out of Operator Action Needed mode...99 To get out of Troubleshooting needed mode...99 To get out of Intervention Required mode... 99 Troubleshooting modes - causes... 99 To find and troubleshoot messages in the Analyzer status screen...100 To flush the fluid transport system...101

Operator actions requested in analyzer messages... 104 To request a tubing refill... 104 To request a liquid sensor adjustment... 104 To request a pump calibration... 104 To request a rinse... 104

Troubleshooting Analyzer messages... 104 To troubleshoot Analyzer messages... 104 Analyzer messages...104

Activity log... 141 About the Activity log... 141 To troubleshoot messages in the Activity log... 142 To see activities in the Activity log... 142 To add a message to the Activity log...142 To filter activities from the Activity log... 142

Analyzer service... 142 For service... 142 To find the installation number (serial number) of the analyzer...142 To find the version of software installed...142

8.

Shutting down, moving and restarting the analyzer Shutdown... 145

Temporary shutdown of the analyzer... 145 When to do a temporary shutdown... 145 To do a temporary shutdown... 145

Long-term shutdown of the analyzer... 145 When to do a long-term shutdown...145 To do a long-term shutdown ... 146

Storing the analyzer...148 To store the analyzer... 148

Moving the analyzer... 148 To move an analyzer that has a charged battery...148 To move an analyzer that does not have a battery... 148

Restarting the analyzer... 149 To restart the analyzer after a temporary shutdown... 149 To restart the analyzer after a long-term shutdown...149

9.

Setup Setup menu structure...151

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To print setups...152

Managing operators... 152 To select the logon procedure... 152 Access profiles...152 To edit an access profile... 152 Anonymous use... 153 To set up anonymous use...153 Default operators... 153 To add an operator... 153 To remove an operator...154 To set a logoff time for all operators... 155 Centralized user management...155 To set up centralized user management... 155

Managing patient profiles... 156 Patient profiles log... 156 To see the data saved in a patient profile...156 To find a patient profile... 156 To edit a patient profile... 156 To add a new patient profile... 156 To delete a patient profile...156

Analyzer operations... 157 To lock the analyzer... 157 To unlock the analyzer... 157 To lock/unlock parameters for measurement...157 To show a message on the analyzer screen...157

Sample counter... 158 To see an overview of measurements and tests done on the analyzer...158 Sample counter... 158 To reset the counters in the User column...158

Analyzer settings... 158 To set up corrective actions on system messages... 158 To enable data to be scanned from barcodes...159 To create a heading for printed data... 159 To enable the screen saver... 159 To set the time and date... 159 To set the acoustic signals... 160 To mute all acoustic signals... 160 To change the screen language... 160 To select a regional setting... 160 To set the barometric pressure...160 To log all measurement activities...161

Analysis setup... 161 Analysis modes... 161 Syringe modes... 161 To edit a syringe mode...161 To create a new syringe mode...162 To remove a measurement mode... 163 To select a default measurement mode... 163 To select a specific patient report layout for an analysis mode... 163 To set up a calibration-verification mode... 164 To set up an ampoule QC mode...164 Capillary modes... 164

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To edit a capillary mode... 164

Ranges and critical limits... 165 About ranges and critical limits... 165 About reference ranges...166 Reference range of measured parameters...166 About critical limits...166 To set the limits for patient age groups... 166 To set up reference ranges and critical limits...167 About reportable ranges...167 To set up reportable ranges... 167 About range of indication... 168

Sample pre-registration... 168 About sample pre-registration...168 To set up sample pre-registration... 168

Sample age evaluation... 168 About sample age evaluation... 168 Maximum sample age...169 To set a maximum sample age...169 Max sample age...169

Patient report layouts... 169 About patient report layouts... 169 To create a patient report layout... 170 To change a patient result layout...171 To create extra items for use in patient report layouts... 172 To select a patient report layout as default... 172 To automatically change the temperature units... 173 To edit a patient report layout...173 To create a patient report layout for FShunt and ctO2(a-v̄)... 174

Patient result settings... 174 To set up automatic printing of acid-base charts... 174 Approval and rejection of patient results... 175 To enable patient result approval/rejection... 175

Parameter settings... 175 To show the parameter bar...175 To hide the parameter bar... 175 To enable/disable a parameter... 175 To set up measuring units for parameters...176 To repress a parameter... 176 To suppress out-of-range results... 176 To fix the number of decimals used in blood-gas results... 176 To enable HbF corrections... 177 To enable the estimation of derived parameters... 177

Editing the slope and offset of a parameter... 177 Operator-defined corrections (offset and slope)... 177 Recommendations about samples to use... 178 Limits for slope and offset values... 179 To edit the offset and slope for a parameter...180

Calibration settings... 181 Details about calibration frequency... 181 To edit the calibration schedule... 181 To link the built-in QC schedule to the calibration schedule... 182

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To set up corrective actions for overdue scheduled calibrations...183

Quality control... 183 Glossary of quality control terms... 183

Registration of QC solutions... 184 Why is it necessary to register QC solutions?... 184 About registration of QC solutions... 184 To register a Radiometer QC solution for ampoule-based QC measurements...184 Data saved during registration of Radiometer QC solutions... 184 To register a non-Radiometer QC solution...185 Data saved during registration of non-Radiometer QC solutions... 186

Quality control solutions... 186 To set up the temperature field for QC measurements... 186

Scheduled QC measurements... 187 To schedule ampoule-based QC measurements... 187 To edit the schedule for ampoule-based QC measurements... 187 Built-in QC measurement frequency... 188 To edit the schedule for built-in QC measurements... 188 To request ampoule-based QC measurements after replacements... 190

Corrective actions on QC results... 190 To set up corrective action for errors in QC results... 190 To set up corrective actions for overdue scheduled QC measurements... 191 To apply operator-defined corrections to QC results... 191 To set up corrective action for errors in built-in QC measurements... 191

QC statistics... 192 To set up automatic print of built-in QC statistics... 192 Statistical factor...192 To set the statistical factor... 192

Westgard Rules... 192 About Westgard Rules...192 Types of Westgard Rule ...192 Description of the lines used in Westgard rule illustrations... 192 Westgard rules and corrective actions... 193 To set up and enable Westgard Rules... 194 To disable/enable Westgard rules... 195

RiLiBÄK rules... 195 About RiLiBÄK rules...195 To add a new RiLiBÄK rule... 195 To apply all RiLiBÄK rules... 196 To edit a RiLiBÄK rule... 196 To remove a RiLiBÄK rule... 197

Analyzer-specific control ranges... 197 About analyzer-specific control ranges... 197 How to establish analyzer-specific control ranges... 197 Stage 1: To do 20 ampoule-based QC measurements...198 Stage 2: To enable the use of fixed standard deviations... 198 Stage 3: To use the analyzer to change control ranges to analyzer-specific control ranges...198 To manually change control ranges to analyzer-specific control ranges... 199

Maintenance setup... 200 About mandatory and operator-defined activities...200

Mandatory maintenance activities... 200 Other activities... 200

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To schedule other activities...200 To set up corrective action for overdue Other activities...201

Operator-defined activities... 201 Operator activities...201 To set up an operator activity... 202 To set up corrective action for pending operator activities... 202 To delete an operator activity...202

Maintenance planning...202 To plan maintenance activities... 202

Replacement warnings... 203 To set up replacement warnings... 203

Note fields... 203 To create standard texts for use in Note fields... 203 To edit standard texts for use in Note fields... 203 To delete standard texts for use in Note fields... 203

Communications... 204 Data security...204 Live Connect... 204 To set up a LIS/HIS connection... 205 To set up a AQURE/RADIANCE connection... 205 Patient data from a LIS/HIS or AQURE/RADIANCE system... 205 To set up automatic requests for patient data... 206 To set up automatic transmission of data to a system... 206 To enable manual patient data requests using Patient lookup... 206 To access the RADIANCE system from the analyzer...207 To set up a QA Portal connection... 207

Printers... 207 To set up automatic printing... 207 To install an external printer for the analyzer... 207 To edit the name of a printer... 208

Data logs and archives... 208 About data logs and archived data logs... 208 To set up automatic archiving... 208 File format of exported data logs and archived data logs... 209 To export data logs...209 To export data from Archived data logs... 209 To create disc space by exporting and deleting archives... 209 To import archived data logs...210

Data backup and restoration... 210 Backup... 210 Destinations for backup data... 210 To schedule automatic backups... 210 To do a manual backup... 211 To restore data from a backup... 211

Saving and loading setups... 211 To save the setup...211 To load a setup... 211 To restore Radiometer default settings... 212

Radiometer default settings... 212 Operators and profiles - default settings...212 Alarm sound (acoustic signal) settings for events - default settings...213

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Language - default setting...213 Analysis setup – default settings... 214 Parameters - default settings... 215 Measurement units - default settings... 216 Calibration schedule - default settings...217 Quality control setups - default settings... 217 Replacement setups - default settings...217 Communication setup - default settings... 218 User-defined patient data items - default settings...218 Corrective actions – default settings... 219 Miscellaneous setup - default settings... 219 Printer setup - default settings...220 Automatic printing - default settings... 220 Automatic archiving - default settings... 220 Automatic backup - default setting... 221 Setups with no default settings... 221 References... 221

10.

Performance characteristics Measured parameters – definitions... 223

About performance characteristics... 224 Overview of performance characteristics... 224 Uncertainty in performance characteristics... 224 To convert an uncertainty at a 68 % confidence level... 225 Bias... 225 Repeatability and reproducibility... 225 Coefficient of variation (CV %)...226 Confidence intervals... 226 Total analytical error...227

About performance tests...227 Test conditions...227 Reference methods/materials... 228

Performance test results... 229 Rounding rules... 229 pH performance test results... 229 pCO2 performance test results... 230 pO2 performance test results... 230 cK+ performance test results... 231 cNa+ performance test results... 231 cCl– performance test results...232 cCa2+ performance test results... 233 cGlu performance test results... 233 pO2 levels - how they affect cGlu results... 235 cLac performance test results... 235 ctHb performance test results... 236 sO2 performance test results...237 FO2Hb performance test results... 238 FCOHb performance test results...239 FMetHb performance test results...239 FHHb performance test results...240 FHbF performance test results... 241

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ctBil performance test results ... 242 ctBil external test results... 242 Precision and bias of aqueous QC system – QUALICHECK7+... 244

Interference test results... 248 Interference tests... 248 pH/blood gas...248 Electrolytes... 248 Metabolites... 251 Oximetry parameters...254 ctBil sensitivity for MCHC variations... 262

Traceability... 264 Traceability to the primary standards at Radiometer...264 pH traceability... 264 pCO2 and pO2 traceability...264 cK+ and cNa+ traceability... 264 cCa2+ traceability... 265 cCl– traceability... 265 cGlu traceability...265 cLac traceability...265 ctHb traceability...265 Saturation – sO2 = 100 % – traceability... 266 Saturation – sO2 = 0 % – traceability... 266 FCOHb – normal value - traceability...266 FCOHb – 100 % - traceability... 266 FMetHb traceability... 266 FHbF traceability... 266 ctBil traceability... 267 References... 267

11.

Derived and input parameters Parameter types... 269 Parameter symbols...269 Input parameters – definitions and acceptable values... 269 Derived parameters...270 Default values of parameters... 271

Definitions of derived parameters... 272 Acid-base derived parameters – definitions...272 Oximetry derived parameters – definitions... 273 Oxygen derived parameters - definitions... 273 Electrolyte derived parameters – definitions...275 Data necessary to derive electrolyte parameters... 275

Calculation of derived parameters... 275 Sample type...275 Units and symbols used in equations... 276

Equations... 276 Equations for acid-base parameters... 276 pH(T) - equation 1... 276 cH+(T) - equation 2...276 pCO2(T) - equation 3... 276 cHCO3–(P) - equation 4...277 cBase(B) - equation 5...277

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cBase(B,ox) - equation 6...277 cBase(Ecf) - equation 7... 277 cBase(Ecf,ox) - equation 8... 277 cHCO3–(P,st) - equation 9... 277 ctCO2(P) - equation 10... 278 ctCO2(B) - equation 11... 278 pH(st) - equation 12...278

Equations for electrolyte parameters... 278 Anion Gap, K+ equation 43... 278 Anion Gap - equation 44... 278 cCa2+(7.4) - equation 45... 278 Equations 46 and 47...279 mOsm - equation 48... 279

Equations for oxygen parameters... 279 pO2(T) - equation 14... 279 pO2(A) - equation 15... 280 pO2(A,T) - equation 16... 280 pO2(a)/FO2(I) - equation 17... 280 pO2(a,T)/ FO2(I) - equation 18... 280 p50 - equation 19... 280 p50(T) - equation 20... 281 p50(st) - equation 21... 281 pO2(A-a) - equation 22... 281 pO2(A-a,T) - equation 23... 282 pO2(a/A) - equation 24... 282 pO2(a/A,T) - equation 25... 282 pO2(x) or px - equation 26... 282 pO2(x,T) - equation 50... 282 ctO2 - equation 27... 283 ctO2(a-v̄) - equation 28... 283 BO2 - equation 29... 284 ctO2(x) or cx - equation 30... 284 ḊO2 - equation 31... 284 Q̇t - equation 32... 284 VO ̇ 2 - equation 33... 285 FShunt - equation 34...285 FShunt(T) - equation 35... 285 RI - equation 36... 286 RI(T) - equation 37... 286 Qx - equation 38... 287 V(B) - equation 42... 287 VCO2/V(dry air) - equation 51... 287 VO2/V(dry air) - equation 52... 288

Equations for oximetry parameters... 288 FHHb - equation 41... 288 FO2Hb - equation 40...288 sO2 - equation 39...288 Hct - equation 13... 288 FHbF - equation 49... 289 Converting results to other units ... 289

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Oxyhemoglobin dissociation curve...290 ODC equations... 290 The ODC reference position... 291 The ODC displacement...291 The actual ODC position...292 To determine the actual displacement... 293 Coordinates on the ODC...295 References... 295

12.

Principles of operation General construction... 297 Sensors... 297

General measurement principles... 297 Introduction... 297 Activity vs. concentration... 298 Fluid transport system... 298 Measurement process... 300 Rinse process... 300

Calibration... 300 Definition... 300 Frequency...300 Calibration solutions... 300

The calibration equation... 301 About the calibration equation... 301 Plotting a calibration line... 301

Sensitivity, status and drift... 301 Sensitivity...301 Status... 303 Drift... 303

Reference electrode...303 Background information - reference electrode...303 Purpose... 303 Fixed potential...303 Use ... 304

Construction - reference electrode... 304 Construction...304

pH and electrolyte sensors... 304 Construction - pH and electrolyte sensors... 304 Construction...304

Measurement principles - pH and electrolyte sensors... 305 Potentiometric measurement principle... 305 Electrode chain... 305 Electrode chain potential... 306 Derived potential... 306 Ion-sensitive membrane... 306 Nernst equation... 306 Activity and concentration... 307

Calibration - pH and electrolyte sensors... 307 Calibrations of pH and electrolyte sensors... 307 Calculation of pH and electrolytes sensitivity...307

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Measurement - pH and electrolyte sensors... 307 Calculation of pH and electrolyte values... 307 Sensor response stability... 308

pCO2 sensor... 308 Construction - pCO2 sensor... 308 Construction...308

Measurement principle - pCO2 sensor... 309 Electrode chain... 309 Electrode chain potential... 309 Measurement process in the pCO2 sensor... 309

Calibration - pCO2 sensor...310 Calibrations of the pCO2 sensor ...310 Calibration levels... 310 Calculation of pCO2 sensitivity... 310

Measurement - pCO2 sensor...311 Calculation of pCO2 values... 311 Sensor response stability... 311

pO2 sensor... 311 Measurement principle - pO2 sensor... 311 Optical system for pO2...311 Measurement sequence... 312 Calculations... 312

Calibration - pO2 sensor... 312 Overview of pO2 calibrations...312 Sensitivity...312 Status... 313

Measurement - pO2 sensor...313 Calculation of pO2 values... 313

Glu and Lac sensors... 314 Construction - Glu and Lac sensors... 314 Construction - Glu and Lac sensors...314 Zero current - Glu and Lac sensors... 314

Calibration - Glu and Lac sensors... 315 Calculation of sensitivity – Glu and Lac sensors... 315

Measurement - Glu and Lac sensors... 315 Calculation of Glu and Lac values... 315 Sensor response stability of the glucose and lactate sensors... 315

Measurement principle - Glu and Lac sensors... 316 Amperometric measurement principle for Glu and Lac sensors... 316 Electrode chain – Glu and Lac sensors...316 Measurement process – Glu and Lac... 316

ctHb and derivates... 317 Description of the optical system... 317 Measured parameters... 317 Construction...318 Measurement cycle...318 Lambert-Beer's law... 319 Absorbance... 319 Total absorbance...319 Continuous spectrum...320 Spectrum examples...320

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Determining concentrations... 320 Matrix of constants...321

Calibration of the optical system... 321 Calibration materials... 321 Zero point... 321 Cuvette path length...321

Correcting for interferences...322 HbF versus HbA... 322 Deviation of results... 322 Detecting HbF...322 Correcting for HbF...323 Repressing spectra... 323 Residual spectrum...323

Measurement and corrections... 323 Calculation of the values of the oximetry parameters... 323 Bilirubin...324 Restrictions ... 324 Corrections for ctHb... 325 Corrections for ctBil...325 References... 325

13.

Specifications Analyzer specifications... 327 Ranges of indication and reportable ranges...327 Measurement precision within specified ranges...328 Product specifications... 333 Environmental specifications...335 Power-supply cords... 336

Consumables specifications... 337 Solution Pack... 337 Function of the Solution Pack...337 Solution Pack specifications... 337

Sensor Cassette... 338 Function of the Sensor Cassette... 338 Sensor Cassette specifications... 338

14.

Graphical symbols Explanation of graphical symbols/icons... 341

15.

Ordering information Solution Packs – code numbers... 345 Sensor Cassettes – code numbers... 345 Spare parts and accessories - code numbers...345 Quality control products – code numbers...346 Recommended Radiometer sampling devices - code numbers...347 Power-supply cords - code numbers... 348

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Dialysis fluids - for non-clinical purposes About dialysis fluids...351 Purpose of the dialysis fluids measurement mode... 351 Warnings about analyzing dialysis fluid samples ... 351 To make sure dialysis fluid analyses do not affect analyzer performance... 352 To calculate the offset and slope corrections for dialysis fluid parameters... 352 To enter new offset and slope corrections for dialysis fluid parameters...353 To create a dialysis fluid mode... 353 To analyze a dialysis fluid sample... 354 To find a dialysis fluid analysis result... 355

17.

Legal information Patents and trademarks... 357 Patents... 357 Trademarks... 357

Legal notices... 357 System performance... 357 Third-party software and trademarks... 357 Warranties and disclaimer... 357 Confidentiality... 358 Changes... 358 End-user license agreement with Microsoft... 358

Index

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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)

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