ABL90 FLEX Instructions for Use Sw Ver 3.5 Sept 2020

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...13 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... 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-v)̄ ... 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... 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 Module... 45 To replace the Inlet Module... 45

Inlet Gasket Holder... 47 To replace the Inlet Gasket Holder...47

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

Inlet Connector Gasket... 52 To replace the Inlet Connector Gasket... 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... 59 To clean the analyzer exterior...59 To clean the QUALICHECK Opener/Adapter...59

Disinfecting... 60 Disinfection - when is it necessary?... 60 To disinfect the touch screen ... 60 To disinfect the analyzer exterior... 60 To disinfect the fluid transport system... 61

Battery... 61 To recharge the analyzer battery...61 To install and service the battery...61

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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... 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

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 Overview of calibrations...89 Frequency of automatic calibrations...89 To find the status of calibrations... 90 Symbols that show the calibration status... 90

Automatic calibrations...90 To request an unscheduled calibration from the Analyzer status screen... 90 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... 93 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... 94 Status in the Calibration log screen... 95

7.

Troubleshooting Troubleshooting - when is it necessary?... 97 About guided troubleshooting... 97 To get out of Operator Action Needed mode...97

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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 Automatic and manual flush ...102 To request an automatic flush of the analyzer ... 102 To perform a manual flush of the analyzer ... 102

Troubleshooting Analyzer messages... 103 To troubleshoot Analyzer messages... 103 Analyzer messages...103

Activity log... 139 About the Activity log... 139 To troubleshoot messages in the Activity log... 140 To see activities in the Activity log... 140 To add a message to the Activity log...140 To filter activities from the Activity log... 140

Analyzer service... 140 For service... 140 To find the installation number (serial number) of the analyzer...140 To find the version of software installed...141

8.

Shutting down, moving and restarting the analyzer Shutdown... 143

Temporary shutdown of the analyzer... 143 When to do a temporary shutdown... 143 To do a temporary shutdown... 143

Long-term shutdown of the analyzer... 143 When to do a long-term shutdown...143 To do a long-term shutdown ... 144

Storing the analyzer...146 To store the analyzer... 146

Moving the analyzer... 146 To move an analyzer that has a charged battery...146 To move an analyzer that does not have a battery... 146

Restarting the analyzer... 147 To restart the analyzer after a temporary shutdown... 147 To restart the analyzer after a long-term shutdown...147

9.

Setup Setup menu structure...149 To print setups...150

Managing operators... 150 To select the logon procedure... 150

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Access profiles...150 To edit an access profile... 150 Anonymous use... 151 To set up anonymous use...151 Default operators... 151 To add an operator... 151 To remove an operator...152 To set a logoff time for all operators... 153 Centralized user management...153 To set up centralized user management... 153

Managing patient profiles... 154 Patient profiles log... 154 To see the data saved in a patient profile...154 To find a patient profile... 154 To edit a patient profile... 154 To add a new patient profile... 154 To delete a patient profile...154

Analyzer operations... 155 To lock the analyzer... 155 To unlock the analyzer... 155 To lock/unlock parameters for measurement...155 To show a message on the analyzer screen...155

Sample counter... 156 To see an overview of measurements and tests done on the analyzer...156 Sample counter... 156 To reset the counters in the User column...156

Analyzer settings... 156 To set up corrective actions on system messages... 156 To enable data to be scanned from barcodes...157 To create a heading for printed data... 157 To enable the screen saver... 157 To set the time and date... 157 To set the acoustic signals... 158 To mute all acoustic signals... 158 To change the screen language... 158 To select a regional setting... 158 To set the barometric pressure...159 To log all measurement activities...159

Analysis setup... 159 Analysis modes... 159 Syringe modes... 159 To edit a syringe mode...159 To create a new syringe mode...160 To remove a measurement mode... 161 To select a default measurement mode... 161 To select a specific patient report layout for an analysis mode... 161 To set up a calibration-verification mode... 162 To set up an ampoule QC mode...162 Capillary modes... 162 To edit a capillary mode... 162

Ranges and critical limits... 163 About ranges and critical limits... 163

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About reference ranges...164 Reference range of measured parameters...164 About critical limits...164 To set the limits for patient age groups... 164 To set up reference ranges and critical limits...165 About reportable ranges...165 To set up reportable ranges... 165 About range of indication... 166

Sample pre-registration... 166 About sample pre-registration...166 To set up sample pre-registration... 166

Sample age evaluation... 166 About sample age evaluation... 166 Maximum sample age...166 To set a maximum sample age...167 Max sample age...167

Patient report layouts... 167 About patient report layouts... 167 To create a patient report layout... 167 To change a patient result layout...169 To create extra items for use in patient report layouts... 170 To select a patient report layout as default... 170 To automatically change the temperature units... 171 To edit a patient report layout...171 To create a patient report layout for FShunt and ctO2(a-v)̄ ... 172

Patient result settings... 172 To set up automatic printing of acid-base charts... 172 Approval and rejection of patient results... 173 To enable patient result approval/rejection... 173

Parameter settings... 173 To show the parameter bar...173 To hide the parameter bar... 173 To enable/disable a parameter... 173 To set up measuring units for parameters...174 To repress a parameter... 174 To suppress out-of-range results... 174 To fix the number of decimals used in blood-gas results... 174 To enable HbF corrections... 175 To enable the estimation of derived parameters... 175

Editing the slope and offset of a parameter... 176 Operator-defined corrections (offset and slope)... 176 Recommendations about samples to use... 177 Limits for slope and offset values... 177 To edit the offset and slope for a parameter...178

Calibration settings... 179 Details about calibration frequency... 179 To edit the calibration schedule... 179 To link the built-in QC schedule to the calibration schedule... 180 To set up corrective actions for overdue scheduled calibrations...181

Quality control... 181 Glossary of quality control terms... 181

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Registration of QC solutions... 182 Why is it necessary to register QC solutions?... 182 About registration of QC solutions... 182 To register a Radiometer QC solution for ampoule-based QC measurements...182 Data saved during registration of Radiometer QC solutions... 182 To register a non-Radiometer QC solution...183 Data saved during registration of non-Radiometer QC solutions... 184

Quality control solutions... 184 To set up the temperature field for QC measurements... 184

Scheduled QC measurements... 185 To schedule ampoule-based QC measurements... 185 To edit the schedule for ampoule-based QC measurements... 185 Built-in QC measurement frequency... 186 To edit the schedule for built-in QC measurements... 186 To request ampoule-based QC measurements after replacements... 187

Corrective actions on QC results... 188 To set up corrective action for errors in QC results... 188 To set up corrective actions for overdue scheduled QC measurements... 188 To apply operator-defined corrections to QC results... 189 To set up corrective action for errors in built-in QC measurements... 189

QC statistics... 189 To set up automatic print of built-in QC statistics... 189 Statistical factor...189 To set the statistical factor... 190

Westgard Rules... 190 About Westgard Rules...190 Types of Westgard Rule ...190 Description of the lines used in Westgard rule illustrations... 190 Westgard rules and corrective actions... 190 To set up and enable Westgard Rules... 192 To disable/enable Westgard rules... 192

RiLiBÄK rules... 193 About RiLiBÄK rules...193 To add a new RiLiBÄK rule... 193 To apply all RiLiBÄK rules... 194 To edit a RiLiBÄK rule... 194 To remove a RiLiBÄK rule... 194

Analyzer-specific control ranges... 194 About analyzer-specific control ranges... 194 How to establish analyzer-specific control ranges... 195 Stage 1: To do 20 ampoule-based QC measurements...195 Stage 2: To enable the use of fixed standard deviations... 195 Stage 3: To use the analyzer to change control ranges to analyzer-specific control ranges...196 To manually change control ranges to analyzer-specific control ranges... 197

Maintenance setup... 198 About mandatory and operator-defined activities...198

Mandatory maintenance activities... 198 Other activities... 198 To schedule other activities...198 To set up corrective action for overdue Other activities...199

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Operator-defined activities... 199 Operator activities...199 To set up an operator activity... 199 To set up corrective action for pending operator activities... 200 To delete an operator activity...200

Maintenance planning...200 To plan maintenance activities... 200

Replacement warnings... 200 To set up replacement warnings... 200

Note fields... 201 To create standard texts for use in Note fields... 201 To edit standard texts for use in Note fields... 201 To delete standard texts for use in Note fields... 201

Communications... 201 Data security...201 LIVE Connect...202 To set up a LIS/HIS connection... 202 To set up a AQURE/RADIANCE connection... 203 Patient data from a LIS/HIS or AQURE/RADIANCE system... 203 To set up automatic requests for patient data... 204 To set up automatic transmission of data to a system... 204 To enable manual patient data requests using Patient lookup... 204

Printers... 205 To set up automatic printing... 205 To install an external printer for the analyzer... 205 To edit the name of a printer... 205

Data logs and archives... 205 About data logs and archived data logs... 205 To set up automatic archiving... 206 File format of exported data logs and archived data logs... 206 To export data logs...206 To export data from Archived data logs... 207 To create disc space by exporting and deleting archives... 207 To import archived data logs...207

Data backup and restoration... 208 Backup... 208 Destinations for backup data... 208 To schedule automatic backups... 208 To do a manual backup... 208 To restore data from a backup... 208

Saving and loading setups... 209 To save the setup...209 To load a setup... 209 To restore Radiometer default settings... 209

Radiometer default settings... 210 Operators and profiles - default settings...210 Alarm sound (acoustic signal) settings for events - default settings...211 Language - default setting...211 Analysis setup – default settings... 211 Parameters - default settings... 213 Measurement units - default settings... 214

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

10.

Performance characteristics Measured parameters – definitions... 221

About performance characteristics... 222 Overview of performance characteristics... 222 Uncertainty in performance characteristics... 222 To convert an uncertainty at a 68 % confidence level... 223 Bias... 223 Repeatability and reproducibility... 223 Coefficient of variation (CV %)...224 Confidence intervals... 224 Total analytical error...225

About performance tests...225 Test conditions...225 Reference methods/materials... 226

Performance test results... 227 Rounding rules... 227 pH performance test results... 227 pCO2 performance test results... 228 pO2 performance test results... 228 cK+ performance test results... 229 cNa+ performance test results... 229 cCl– performance test results...230 cCa2+ performance test results... 231 cGlu performance test results... 231 pO2 levels - how they affect cGlu results... 233 cLac performance test results... 233 ctHb performance test results... 234 sO2 performance test results...235 FO2Hb performance test results... 236 FCOHb performance test results...237 FMetHb performance test results...237 FHHb performance test results...238 FHbF performance test results... 239 ctBil performance test results ... 239 ctBil external test results... 240

Interference test results... 242 Interference tests... 242

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pH/blood gas...242 Electrolytes... 243 Metabolites... 246 Oximetry parameters...249 ctBil sensitivity for MCHC variations... 257

Traceability... 259 Traceability to the primary standards at Radiometer...259 pH traceability... 259 pCO2 and pO2 traceability...259 cK+ and cNa+ traceability... 259 cCa2+ traceability... 260 cCl– traceability... 260 cGlu traceability...260 cLac traceability...260 ctHb traceability...260 Saturation – sO2 = 100 % – traceability... 261 Saturation – sO2 = 0 % – traceability... 261 FCOHb – normal value - traceability...261 FCOHb – 100 % - traceability... 261 FMetHb traceability... 261 FHbF traceability... 261 ctBil traceability... 262 References... 262

11.

Derived and input parameters Parameter types... 265 Parameter symbols...265 Input parameters – definitions and acceptable values... 265 Derived parameters...266 Default values of parameters... 267

Definitions of derived parameters... 268 Acid-base derived parameters – definitions...268 Oximetry derived parameters – definitions... 269 Oxygen derived parameters - definitions... 269 Electrolyte derived parameters – definitions...271 Data necessary to derive electrolyte parameters... 271

Calculation of derived parameters... 271 Sample type...271 Units and symbols used in equations... 272

Equations... 272 Equations for acid-base parameters... 272 pH(T) - equation 1... 272 cH+(T) - equation 2...272 pCO2(T) - equation 3... 272 cHCO3–(P) - equation 4...273 cBase(B) - equation 5...273 cBase(B,ox) - equation 6...273 cBase(Ecf) - equation 7... 273 cBase(Ecf,ox) - equation 8... 273 cHCO3–(P,st) - equation 9... 273 ctCO2(P) - equation 10... 274

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ctCO2(B) - equation 11... 274 pH(st) - equation 12...274

Equations for electrolyte parameters... 274 Anion Gap, K+ equation 43... 274 Anion Gap - equation 44... 274 cCa2+(7.4) - equation 45... 274 Equations 46 and 47...275 mOsm - equation 48... 275

Equations for oxygen parameters... 275 pO2(T) - equation 14... 275 pO2(A) - equation 15... 276 pO2(A,T) - equation 16... 276 pO2(a)/FO2(I) - equation 17... 276 pO2(a,T)/ FO2(I) - equation 18... 276 p50 - equation 19... 276 p50(T) - equation 20... 277 p50(st) - equation 21... 277 pO2(A-a) - equation 22... 277 pO2(A-a,T) - equation 23... 278 pO2(a/A) - equation 24... 278 pO2(a/A,T) - equation 25... 278 pO2(x) or px - equation 26... 278 pO2(x,T) - equation 50... 278 ctO2 - equation 27... 279 ctO2(a-v̄) - equation 28... 279 BO2 - equation 29... 280 ctO2(x) or cx - equation 30... 280 ḊO2 - equation 31... 280 Q̇t - equation 32... 280 V̇O2 - equation 33... 281 FShunt - equation 34...281 FShunt(T) - equation 35... 281 RI - equation 36... 282 RI(T) - equation 37... 282 Qx - equation 38... 283 V(B) - equation 42... 283 VCO2/V(dry air) - equation 51... 283 VO2/V(dry air) - equation 52... 284

Equations for oximetry parameters... 284 FHHb - equation 41... 284 FO2Hb - equation 40...284 sO2 - equation 39...284 Hct - equation 13... 284 FHbF - equation 49... 285 Converting results to other units ... 285

Oxyhemoglobin dissociation curve...286 ODC equations... 286 The ODC reference position... 287 The ODC displacement...287 The actual ODC position...288 To determine the actual displacement... 289

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Coordinates on the ODC...290 References... 291

12.

Principles of operation General construction... 293 Sensors... 293

General measurement principles... 293 Introduction... 293 Activity vs. concentration... 294 Fluid transport system... 294 Measurement process... 295 Rinse process... 296

Calibration... 296 Definition... 296 Frequency...296 Calibration solutions... 296

The calibration equation... 296 About the calibration equation... 296 Plotting a calibration line... 296

Sensitivity, status and drift... 297 Sensitivity...297 Status... 299 Drift... 299

Reference electrode...299 Background information - reference electrode...299 Purpose... 299 Fixed potential...299 Use ... 300

Construction - reference electrode... 300 Construction...300

pH and electrolyte sensors... 300 Construction - pH and electrolyte sensors... 300 Construction...300

Measurement principles - pH and electrolyte sensors... 301 Potentiometric measurement principle... 301 Electrode chain... 301 Electrode chain potential... 302 Derived potential... 302 Ion-sensitive membrane ... 302 Nernst equation... 302 Activity and concentration... 303

Calibration - pH and electrolyte sensors... 303 Calibrations of pH and electrolyte sensors... 303 Calculation of pH and electrolytes sensitivity...303

Measurement - pH and electrolyte sensors... 303 Calculation of pH and electrolyte values... 303 Sensor response stability... 304

pCO2 sensor... 304 Construction - pCO2 sensor... 304 Construction...304

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Measurement principle - pCO2 sensor... 305 Electrode chain... 305 Electrode chain potential... 305 Measurement process in the pCO2 sensor... 305

Calibration - pCO2 sensor...306 Calibrations of the pCO2 sensor ...306 Calibration levels... 306 Calculation of pCO2 sensitivity... 306

Measurement - pCO2 sensor...307 Calculation of pCO2 values... 307 Sensor response stability... 307

pO2 sensor... 307 Measurement principle - pO2 sensor... 307 Optical system for pO2...307 Measurement sequence... 308 Calculations... 308

Calibration - pO2 sensor... 308 Overview of pO2 calibrations...308 Sensitivity...308 Status... 309

Measurement - pO2 sensor...309 Calculation of pO2 values... 309

Glu and Lac sensors... 310 Construction - Glu and Lac sensors... 310 Construction - Glu and Lac sensors...310 Zero current - Glu and Lac sensors... 310

Calibration - Glu and Lac sensors... 311 Calculation of sensitivity – Glu and Lac sensors... 311

Measurement - Glu and Lac sensors... 311 Calculation of Glu and Lac values... 311 Sensor response stability of the glucose and lactate sensors... 311

Measurement principle - Glu and Lac sensors... 312 Amperometric measurement principle for Glu and Lac sensors... 312 Electrode chain – Glu and Lac sensors...312 Measurement process – Glu and Lac... 312

ctHb and derivates... 313 Description of the optical system... 313 Measured parameters... 313 Construction...314 Measurement cycle...314 Lambert-Beer's law... 315 Absorbance... 315 Total absorbance...315 Continuous spectrum...316 Spectrum examples...316 Determining concentrations... 316 Matrix of constants...317

Calibration of the optical system... 317 Calibration materials... 317 Zero point... 317 Cuvette path length...317

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Correcting for interferences...318 HbF versus HbA... 318 Deviation of results... 318 Detecting HbF...318 Correcting for HbF...319 Repressing spectra... 319 Residual spectrum...319

Measurement and corrections... 319 Calculation of the values of the oximetry parameters... 319 Bilirubin...320 Restrictions ... 320 Corrections for ctHb... 321 Corrections for ctBil...321 References... 321

13.

Specifications Analyzer specifications... 323 Ranges of indication and reportable ranges...323 Measurement precision within specified ranges...324 Product specifications... 329 Environmental specifications...331 Power-supply cords... 332

Consumables specifications... 333 Solution Pack... 333 Function of the Solution Pack...333 Solution Pack specifications... 333

Sensor Cassette... 334 Function of the Sensor Cassette... 334 Sensor Cassette specifications... 335

14.

Graphical symbols Explanation of graphical symbols/icons... 337

15.

Ordering information Solution Packs – code numbers... 341 Sensor Cassettes – code numbers... 341 Spare parts and accessories - code numbers...341 Quality control products – code numbers...342 Recommended Radiometer sampling devices - code numbers...343 Power-supply cords - code numbers... 344

16.

Legal information Patents and trademarks... 345 Patents... 345 Trademarks... 345

Legal notices... 345 System performance... 345

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Third-party software and trademarks... 345 Warranties and disclaimer... 345 Confidentiality... 346 Changes... 346 End-user license agreement with Microsoft... 346

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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