ABL90 FLEX PLUS Instructions for Use Sw Ver 3.5 Feb 2021

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...8 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 get quick access to the start screen...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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ABL90 FLEX PLUS: Instructions for use

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... 19 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)... 26

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... 27 To request patient data automatically when connected to a LIS/HIS system...27 To request patient data using Patient lookup...28 To edit data in the Patient identification screen... 28

Patient results... 28 To find a patient result...28 Symbols on patient results... 28 About ranges and critical limits... 29 Status in the Patient results log... 30 To see messages on patient results... 30 To troubleshoot messages on results... 30 To see the acid-base chart for a result... 30

Reviewing and editing patient results... 30 To filter data from the Patient results log...30 To see trends in a patient's results... 31 To see the audit trail on a patient result... 31 To add a note to a patient result ... 31 To remove a parameter from a patient result... 32 To show a parameter in a patient result... 32 Approval and rejection of patient results... 32 To approve a patient result...32 To reject a patient result... 33

Critical limit notification... 33 About Critical limit notification... 33 To enable Critical limit notification... 33 To use Critical limit notification... 33 Pending results log...34 To access the Pending results log... 34 Input fields for the Patient report layout...34 References...34

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4.

Replacements and maintenance General warnings and cautions... 37 Types of consumables...37 To order products for use with your analyzer... 38 Replacement intervals for consumables and Inlet Connector Gasket...38

Replacements... 38 Solution Pack... 38 To see the Solution Pack status...38 To replace the Solution Pack... 39 Can a Solution Pack be used again?...40 Status logs... 41 To print Solution Pack status logs... 41 To export Solution Pack status logs... 41

Sensor Cassette... 41 To see the Sensor Cassette status... 41 To replace the Sensor Cassette... 41 Calibration frequency after a Sensor Cassette SC90 replacement ...42 Can a Sensor Cassette be used again?...42 Status logs... 43 To print Sensor Cassette status logs... 43 To export Sensor Cassette status logs...43

Thermal printer paper... 43 To replace the thermal printer paper...43 Protection of printed data... 44

Inlet Module... 44 To replace the Inlet Module... 44

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

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

Inlet Connector Gasket... 49 To replace the Inlet Connector Gasket... 49

Maintenance... 51 Cleaning... 51 Cleaning - when is it necessary?... 51 To clean the inlet gasket... 52 To clean the touch screen... 52 To clean the analyzer exterior...52 To clean the QUALICHECK Opener/Adapter...53

Disinfecting... 53 Disinfection - when is it necessary?... 53 To disinfect the touch screen ... 53 To disinfect the analyzer exterior... 54 To disinfect the fluid transport system... 54

Battery... 54 To recharge the analyzer battery...54 To install and service the battery...54

Disposal... 55 To dispose of the analyzer...55

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Connecting peripherals... 55 To connect a USB external keyboard / mouse... 55 To connect a non-USB (PS/2) external keyboard or mouse... 55 To connect an external barcode reader...55 To connect the analyzer to a network...56 Reference... 56

5.

Quality control Overview of quality control management... 57 To find the status of QC measurements...57 Symbols that show the status of QCs...57

Automatic quality control management... 57 About automatic quality control management... 57 About system checks...58 Overview of automatic quality management... 58

Built-in QC... 59 About built-in QC measurements...59 Built-in QC measurement frequency... 60 To request an unscheduled built-in QC measurement... 60

Built-in QC results... 60 Status of built-in QC measurements... 60 To find a built-in QC result... 61 Symbols on built-in QC results...61 To see messages on built-in QC results... 61 To troubleshoot messages on built-in QC results...62

Quality control management done by operators... 62 Quality control management that can be done by operators...62

Ampoule-based QC measurements... 62 QC solutions for ampoule-based measurements... 62 How to get good ampoule-based QC measurement results... 63 To prepare a Radiometer QC ampoule for use... 63 To do a Radiometer ampoule-based QC measurement from the Analyzer status screen...65 To do an ampoule-based QC measurement from the start screen... 67 To edit QC identification data...68

Ampoule-based QC results... 69 Status of ampoule-based QC measurements...69 To find an ampoule-based QC result... 69 Symbols on ampoule-based QC results... 69 To see messages on ampoule-based QC results...69 To troubleshoot messages on results... 70

Calibration verification...70 About calibration verification... 70 Frequency of calibration verification... 70

Stage 1 - Analyzing different levels of control solution... 71 To prepare a Radiometer calibration-verification ampoule for use...71 To do a calibration-verification measurement... 72

Stage 2 - Using results to verify reportable ranges... 73 To find a calibration-verification measurement result... 73 Symbols on calibration-verification measurement results...74

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To temperature correct calibration-verification results based on Range+ QUALICHECK measurements... 74 To use temperature-corrected calibration-verification results...75 To temperature correct QUALICHECK7+ pH, pO2 and pCO2 control ranges ... 75 To age correct QUALICHECK7+ control ranges for cCrea ...76 To use corrected QUALICHECK7+ control ranges... 77 To temperature correct pH, pCO2 and pO2 results based on QUALICHECK7+ material...78 To age correct cCrea results based on QUALICHECK7+ material ... 78

Stage 3 - Changing reportable ranges... 79 To change the reportable range of parameters... 79

Reviewing QC statistics... 79 To find and print QC statistics... 79 QC plots... 80 To find a QC plot...80 To filter data from the Quality control log... 81 To see trends in QC results...81

WDC file export...81 About WDC... 81 To export WDC files...81

Analyzing QC solutions in other modes... 82 About analyzing QC solutions in other modes...82 To temperature correct results based on QUALICHECK5+ solutions... 82

6.

Calibration Overview of calibrations...83 Frequency of automatic calibrations...83 To find the status of calibrations... 84 Symbols that show the calibration status... 84

Automatic calibrations...85 To request an unscheduled calibration from the Analyzer status screen... 85 To request an unscheduled calibration from the menu... 85

Manual tHb calibrations... 85 To do a tHb calibration...85

Calibration results... 87 To find a calibration result... 87 Identification of calibrations in the Calibration log screen...87 Understanding calibration results... 88 To see messages on a calibration result... 88 To troubleshoot messages on results... 88

Reviewing calibration results... 88 To filter data from the Calibration log...88 To see trends in calibration results... 89 Status in the Calibration log screen... 89

7.

Troubleshooting Troubleshooting - when is it necessary?... 91 About guided troubleshooting... 91 To get out of Operator Action Needed mode...91 To get out of Troubleshooting needed mode...91

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To get out of Intervention Required mode... 91 Troubleshooting modes - causes... 91 To find and troubleshoot messages in the Analyzer status screen... 92 To flush the fluid transport system... 93

Operator actions requested in analyzer messages... 96 To request a tubing refill... 96 To request a liquid sensor adjustment...96 To request a pump calibration...96 To request a rinse... 96 Automatic and manual flush ... 96 To request an automatic flush of the analyzer ... 96 To perform a manual flush of the analyzer ...96

Troubleshooting Analyzer messages... 96 To troubleshoot Analyzer messages... 96 Analyzer messages... 97

Activity log... 135 About the Activity log... 135 To troubleshoot messages in the Activity log... 135 To see activities in the Activity log... 135 To add a message to the Activity log...135 To filter activities from the Activity log... 136

Analyzer service... 136 For service... 136 To find the installation number (serial number) of the analyzer...136 To find the version of software installed...136

8.

Shutting down, moving and restarting the analyzer Shutdown... 137

Temporary shutdown of the analyzer... 137 When to do a temporary shutdown... 137 To do a temporary shutdown... 137

Long-term shutdown of the analyzer... 137 When to do a long-term shutdown...137 To do a long-term shutdown ... 138

Storing the analyzer...139 To store the analyzer... 139

Moving the analyzer... 140 To move an analyzer that has a charged battery...140 To move an analyzer that does not have a battery... 140

Restarting the analyzer... 140 To restart the analyzer after a temporary shutdown... 140 To restart the analyzer after a long-term shutdown...140

9.

Setup Setup menu structure...143 To print setups...144

Analyzer configuration... 144 Analyzer configuration... 144 To change the analyzer configuration... 144

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Managing operators... 144 To select the logon procedure... 144 Access profiles...145 To edit an access profile... 145 Anonymous use... 145 To set up anonymous use...146 Default operators... 146 To add an operator... 146 To remove an operator...147 To set a logoff time for all operators... 148 Centralized user management...148 To set up centralized user management... 148

Managing patient profiles... 149 Patient profiles log... 149 To see the data saved in a patient profile...149 To find a patient profile... 149 To edit a patient profile... 149 To add a new patient profile... 149 To delete a patient profile...149

Analyzer operations... 150 To lock the analyzer... 150 To unlock the analyzer... 150 To lock/unlock parameters for measurement...150 To show a message on the analyzer screen...150

Sample counter... 151 To see an overview of measurements and tests done on the analyzer...151 Sample counter... 151 To reset the counters in the User column...151

Analyzer settings... 151 To set up corrective actions on system messages... 151 To enable data to be scanned from barcodes...152 To create a heading for printed data... 152 To enable the screen saver... 152 To set the time and date... 152 To set the acoustic signals... 153 To mute all acoustic signals... 153 To change the screen language... 153 To select a regional setting... 153 To set the barometric pressure...154 To log all measurement activities...154

Analysis setup... 154 Analysis modes... 154 Syringe modes... 154 To edit a syringe mode...154 To create a new syringe mode...155 To remove a measurement mode... 156 To select a default measurement mode... 156 To select a specific patient report layout for an analysis mode... 156 To set up a calibration-verification mode... 157 To set up an ampoule QC mode...157 Capillary modes... 157 To edit a capillary mode... 157

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Ranges and critical limits... 158 About ranges and critical limits... 158 About reference ranges...159 Reference range of measured parameters...159 About critical limits...159 To set the limits for patient age groups... 159 To set up reference ranges and critical limits...160 About reportable ranges...160 To set up reportable ranges... 160 About range of indication... 161

Sample pre-registration... 161 About sample pre-registration...161 To set up sample pre-registration... 161

Sample age evaluation... 161 About sample age evaluation... 161 Maximum sample age... 162 To set a maximum sample age...162 Max sample age...162

Patient report layouts... 162 About patient report layouts... 162 To create a patient report layout... 163 To change a patient result layout...164 To create extra items for use in patient report layouts... 165 To select a patient report layout as default... 165 To automatically change the temperature units... 166 To edit a patient report layout...166 To create a patient report layout for FShunt and ctO2(a-v̄)... 167

Patient result settings... 167 To set up automatic printing of acid-base charts... 167 Approval and rejection of patient results... 168 To enable patient result approval/rejection... 168

Parameter settings... 168 To show the parameter bar...168 To hide the parameter bar... 168 To enable/disable a parameter... 168 To set up measuring units for parameters...169 To repress a parameter... 169 To suppress out-of-range results... 169 To fix the number of decimals used in blood-gas results... 169 To enable HbF corrections... 170 To enable the estimation of derived parameters... 170

Editing the slope and offset of a parameter... 170 Operator-defined corrections (offset and slope)... 170 Recommendations about samples to use... 171 Limits for slope and offset values... 172 To edit the offset and slope for a parameter...173

Calibration settings... 174 Details about calibration frequency... 174 To edit the calibration schedule... 175 To link the built-in QC schedule to the calibration schedule... 176 To set up corrective actions for overdue scheduled calibrations...176

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Quality control... 176 Glossary of quality control terms... 176

Registration of QC solutions... 177 Why is it necessary to register QC solutions?... 177 About registration of QC solutions... 177 To register a Radiometer QC solution for ampoule-based QC measurements...177 Data saved during registration of Radiometer QC solutions... 178 To register a non-Radiometer QC solution...179 Data saved during registration of non-Radiometer QC solutions... 179

Quality control solutions... 179 To set up the temperature field for QC measurements... 179

Scheduled QC measurements... 180 To schedule ampoule-based QC measurements... 180 To edit the schedule for ampoule-based QC measurements... 180 Built-in QC measurement frequency... 181 To edit the schedule for built-in QC measurements... 181 To request ampoule-based QC measurements after replacements... 183

Corrective actions on QC results... 183 To set up corrective action for errors in QC results... 183 To set up corrective actions for overdue scheduled QC measurements... 184 To apply operator-defined corrections to QC results... 184 To set up corrective action for errors in built-in QC measurements... 184

QC statistics... 185 To set up automatic print of built-in QC statistics... 185 Statistical factor...185 To set the statistical factor... 185

Westgard Rules... 185 About Westgard Rules...185 Types of Westgard Rule ...185 Description of the lines used in Westgard rule illustrations... 185 Westgard rules and corrective actions... 186 To set up and enable Westgard Rules... 187 To disable/enable Westgard rules... 188

RiLiBÄK rules... 188 About RiLiBÄK rules...188 To add a new RiLiBÄK rule... 188 To apply all RiLiBÄK rules... 189 To edit a RiLiBÄK rule... 189 To remove a RiLiBÄK rule... 190

Analyzer-specific control ranges... 190 About analyzer-specific control ranges... 190 How to establish analyzer-specific control ranges... 190 Stage 1: To do 20 ampoule-based QC measurements...191 Stage 2: To enable the use of fixed standard deviations... 191 Stage 3: To use the analyzer to change control ranges to analyzer-specific control ranges...191 To manually change control ranges to analyzer-specific control ranges... 192

Maintenance setup... 193 About mandatory and operator-defined activities...193

Mandatory maintenance activities... 193 Other activities... 193 To schedule other activities...193

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To set up corrective action for overdue Other activities...194

Operator-defined activities... 194 Operator activities...194 To set up an operator activity... 195 To set up corrective action for pending operator activities... 195 To delete an operator activity...195

Maintenance planning...195 To plan maintenance activities... 195

Replacement warnings... 196 To set up replacement warnings... 196

Note fields... 196 To create standard texts for use in Note fields... 196 To edit standard texts for use in Note fields... 196 To delete standard texts for use in Note fields... 196

Communications... 197 Data security...197 LIVE Connect...197 To set up a LIS/HIS connection... 198 To set up a AQURE/RADIANCE connection... 198 Patient data from a LIS/HIS or AQURE/RADIANCE system... 198 To set up automatic requests for patient data... 199 To set up automatic transmission of data to a system... 199 To enable manual patient data requests using Patient lookup... 199

Printers... 200 To set up automatic printing... 200 To install an external printer for the analyzer... 200 To edit the name of a printer... 200

Data logs and archives... 200 About data logs and archived data logs... 200 To set up automatic archiving... 201 File format of exported data logs and archived data logs... 201 To export data logs...201 To export data from Archived data logs... 202 To create disc space by exporting and deleting archives... 202 To import archived data logs...202

Data backup and restoration... 203 Backup... 203 Destinations for backup data... 203 To schedule automatic backups... 203 To do a manual backup... 203 To restore data from a backup... 203

Saving and loading setups... 204 To save the setup...204 To load a setup... 204 To restore Radiometer default settings... 204

Radiometer default settings... 205 Operators and profiles - default settings...205 Alarm sound (acoustic signal) settings for events - default settings...206 Language - default setting...206 Analysis setup – default settings... 206 Parameters - default settings... 208

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Measurement units - default settings... 209 Calibration schedule - default settings...210 Quality control setups - default settings... 210 Replacement setups - default settings...211 Communication setup - default settings... 211 User-defined patient data items - default settings...211 Corrective actions – default settings... 212 Miscellaneous setup - default settings... 212 Printer setup - default settings...213 Automatic printing - default settings... 213 Automatic archiving - default settings... 213 Automatic backup - default setting... 214 Setups with no default settings... 214 References... 214

10.

Performance characteristics Measured parameters – definitions... 215

About performance characteristics... 216 Overview of performance characteristics... 216 Uncertainty in performance characteristics... 216 To convert an uncertainty at a 68 % confidence level... 217 Bias... 217 Repeatability and reproducibility... 218 Coefficient of variation (CV %)...218 Confidence intervals... 219 Total analytical error...219

About performance tests...219 Test conditions...219 Reference methods/materials... 220

Performance test results... 222 Rounding rules... 222 pH performance test results... 222 pCO2 performance test results... 223 pO2 performance test results... 224 cK+ performance test results... 226 cNa+ performance test results... 227 cCl– performance test results...227 cCa2+ performance test results... 229 cGlu performance test results... 230 pO2 levels - how they affect cGlu results... 235 cLac performance test results... 236 ctHb performance test results... 239 sO2 performance test results...240 FO2Hb performance test results... 241 FCOHb performance test results...242 FMetHb performance test results...243 FHHb performance test results...244 FHbF performance test results... 245 ctBil performance test results ... 246 ctBil external test results... 248 cUrea performance test results... 250

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cBUN performance test results... 251 cCrea performance test results... 251 Precision and bias of aqueous QC system – QUALICHECK7+... 252

Interference test results... 256 Interference tests... 256 pH/blood gas...257 Electrolytes... 257 Metabolites... 260 Oximetry parameters...275 ctBil sensitivity for MCHC variations... 283

Traceability... 285 Traceability to the primary standards at Radiometer...285 pH traceability... 285 pCO2 and pO2 traceability...285 cK+ and cNa+ traceability... 285 cCa2+ traceability... 286 cCl– traceability... 286 cGlu traceability...286 cLac traceability...286 ctHb traceability...286 Saturation – sO2 = 100 % – traceability... 287 Saturation – sO2 = 0 % – traceability... 287 FCOHb – normal value - traceability...287 FCOHb – 100 % - traceability... 287 FMetHb traceability... 287 FHbF traceability... 287 ctBil traceability... 288 cUrea/BUN traceability...288 cCrea traceability... 288 References... 288

11.

Derived and input parameters Parameter types... 291 Parameter symbols...291 Input parameters – definitions and acceptable values... 291 Derived parameters...292 Default values of parameters... 293

Definitions of derived parameters... 294 Acid-base derived parameters – definitions...294 Oximetry derived parameters – definitions... 295 Oxygen derived parameters - definitions... 295 Electrolyte derived parameters – definitions...297 Data necessary to derive electrolyte parameters... 297 Metabolite derived parameters – definitions... 297

Calculation of derived parameters... 298 Sample type...298 Units and symbols used in equations... 298 Units of derived parameters – metabolite parameters... 299

Equations... 299 Equations for acid-base parameters... 299 pH(T) - equation 1... 299

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cH+(T) - equation 2...299 pCO2(T) - equation 3... 299 cHCO3–(P) - equation 4...300 cBase(B) - equation 5...300 cBase(B,ox) - equation 6...300 cBase(Ecf) - equation 7... 300 cBase(Ecf,ox) - equation 8... 300 cHCO3–(P,st) - equation 9... 300 ctCO2(P) - equation 10... 301 ctCO2(B) - equation 11... 301 pH(st) - equation 12...301

Equations for electrolyte parameters... 301 Anion Gap, K+ equation 43... 301 Anion Gap - equation 44... 301 cCa2+(7.4) - equation 45... 301 Equations 46 and 47...302 mOsm - equation 48... 302

Equations for oxygen parameters... 302 pO2(T) - equation 14... 302 pO2(A) - equation 15... 303 pO2(A,T) - equation 16... 303 pO2(a)/FO2(I) - equation 17... 303 pO2(a,T)/ FO2(I) - equation 18... 303 p50 - equation 19... 303 p50(T) - equation 20... 304 p50(st) - equation 21... 304 pO2(A-a) - equation 22... 304 pO2(A-a,T) - equation 23... 305 pO2(a/A) - equation 24... 305 pO2(a/A,T) - equation 25... 305 pO2(x) or px - equation 26... 305 pO2(x,T) - equation 50... 305 ctO2 - equation 27... 306 ctO2(a-v̄) - equation 28... 306 BO2 - equation 29... 307 ctO2(x) or cx - equation 30... 307 ḊO2 - equation 31... 307 Q̇t - equation 32... 307 V̇O2 - equation 33... 308 FShunt - equation 34...308 FShunt(T) - equation 35... 308 RI - equation 36... 309 RI(T) - equation 37... 309 Qx - equation 38... 310 V(B) - equation 42... 310 VCO2/V(dry air) - equation 51... 310 VO2/V(dry air) - equation 52... 311

Equations for oximetry parameters... 311 FHHb - equation 41... 311 FO2Hb - equation 40...311 sO2 - equation 39...311

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Hct - equation 13... 311 FHbF - equation 49... 312

Equations for metabolite parameters... 312 GFR if AA - equation 53... 312 GFR if non AA - equation 54... 312 GFR if JP - equation 55... 312 GFR Schwartz - equation 56... 312 GFRmdrd AA - equation 57...313 GFRmdrd nonAA - equation 58...313 GFRckd AA - equation 59... 313 GFRckd nonAA - equation 60... 313 Urea/BUN-to-creatinine ratio - equation 61...313 Converting results to other units ... 313

Oxyhemoglobin dissociation curve...314 ODC equations... 314 The ODC reference position... 315 The ODC displacement...315 The actual ODC position...316 To determine the actual displacement... 317 Coordinates on the ODC...319 References... 319

12.

Principles of operation General construction... 321 Sensors... 321

General measurement principles... 321 Introduction... 321 Activity vs. concentration... 322 Fluid transport system... 322 Measurement process... 323 Rinse process... 324

Calibration... 324 Definition... 324 Frequency...324 Calibration solutions... 324

The calibration equation... 324 About the calibration equation... 324 Plotting a calibration line... 325

Sensitivity, status and drift... 325 Sensitivity...325 Status... 327 Drift... 327

Reference electrode...327 Background information - reference electrode...327 Purpose... 327 Fixed potential...327 Use ... 328

Construction - reference electrode... 328 Construction...328

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pH and electrolyte sensors... 328 Construction - pH and electrolyte sensors... 328 Construction...328

Measurement principles - pH and electrolyte sensors... 329 Potentiometric measurement principle... 329 Electrode chain... 329 Electrode chain potential... 330 Derived potential... 330 Ion-sensitive membrane ... 330 Nernst equation... 330 Activity and concentration... 331

Calibration - pH and electrolyte sensors... 331 Calibrations of pH and electrolyte sensors... 331 Calculation of pH and electrolytes sensitivity...331

Measurement - pH and electrolyte sensors... 331 Calculation of pH and electrolyte values... 331 Sensor response stability... 332

pCO2 sensor... 332 Construction - pCO2 sensor... 332 Construction...332

Measurement principle - pCO2 sensor... 333 Electrode chain... 333 Electrode chain potential... 333 Measurement process in the pCO2 sensor... 333

Calibration - pCO2 sensor...334 Calibrations of the pCO2 sensor ...334 Calibration levels... 334 Calculation of pCO2 sensitivity... 334

Measurement - pCO2 sensor...335 Calculation of pCO2 values... 335 Sensor response stability... 335

pO2 sensor... 335 Measurement principle - pO2 sensor... 335 Optical system for pO2...335 Measurement sequence... 336 Calculations... 336

Calibration - pO2 sensor... 336 Overview of pO2 calibrations...336 Sensitivity...336 Status... 337

Measurement - pO2 sensor...337 Calculation of pO2 values... 337

Glu and Lac sensors... 338 Construction - Glu and Lac sensors... 338 Construction - Glu and Lac sensors...338 Zero current - Glu and Lac sensors... 338

Calibration - Glu and Lac sensors... 339 Calculation of sensitivity – Glu and Lac sensors... 339

Measurement - Glu and Lac sensors... 339 Calculation of Glu and Lac values... 339 Sensor response stability of the glucose and lactate sensors... 339

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Measurement principle - Glu and Lac sensors... 340 Amperometric measurement principle for Glu and Lac sensors... 340 Electrode chain – Glu and Lac sensors...340 Measurement process – Glu and Lac... 340

Creatinine sensors... 341 2-sensor configuration... 341 Construction - Creatinine sensors... 341 Zero current - cCrea... 342 Determination of analyte levels in the calibrators...342 Calculation of sensitivity – Creatinine...342 Calculation of cCrea values...343 Measurement process – creatinine...343 Electrode chain – creatinine...344 Sensor response stability of the creatinine sensors... 344

Urea/BUN sensors...344 Construction...344 Potentiometric measurement principle... 345 Electrode chain potential... 345 Derived potential... 345 Enzyme layer... 346 Ion-sensitive membrane... 346 Nernst equation... 346 Calibration of the urea/BUN sensor...346 Calculation of cUrea/BUN values... 346 Sensor response stability of the urea/BUN sensor... 347

ctHb and derivates... 347 Description of the optical system... 347 Measured parameters... 347 Construction...347 Measurement cycle...348 Lambert-Beer's law... 348 Absorbance... 349 Total absorbance...349 Continuous spectrum...349 Spectrum examples...350 Determining concentrations... 350 Matrix of constants...351

Calibration of the optical system... 351 Calibration materials... 351 Zero point... 351 Cuvette path length...351

Correcting for interferences...351 HbF versus HbA... 351 Deviation of results... 352 Detecting HbF...352 Correcting for HbF...352 Repressing spectra... 352 Residual spectrum...353

Measurement and corrections... 353 Calculation of the values of the oximetry parameters... 353 Bilirubin...353 Restrictions ... 354

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Corrections for ctHb... 354 Corrections for ctBil...355 References... 355

13.

Specifications Analyzer specifications... 357 Ranges of indication and reportable ranges...357 Measurement precision within specified ranges...359 Product specifications... 363 Environmental specifications...366 Power-supply cords... 367

Consumables specifications... 368 Solution Pack... 368 Function of the Solution Pack...368 Solution Pack specifications... 368

Sensor Cassette... 370 Function of the Sensor Cassette... 370 Sensor Cassette specifications... 370

14.

Graphical symbols Explanation of graphical symbols/icons... 373

15.

Ordering information Solution Packs – code numbers... 377 Sensor Cassettes – code numbers... 377 Spare parts and accessories - code numbers...378 Quality control products – code numbers...378 Recommended Radiometer sampling devices - code numbers...379 Power-supply cords - code numbers... 381

16.

Legal information Patents and trademarks... 383 Patents... 383 Trademarks... 383

Legal notices... 383 System performance... 383 Third-party software and trademarks... 383 Warranties and disclaimer... 383 Confidentiality... 384 Changes... 384 End-user license agreement with Microsoft... 384

Index

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Introduction Intended use

The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, creatinine, urea/BUN and oximetry in whole blood. The ABL90 FLEX PLUS 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 PLUS analyzer can be connected to the RADIANCE system. The RADIANCE system enables communication between the RADIANCE server and the ABL90 FLEX PLUS 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) cCrea (Creatinine Concentration)* cUrea/BUN (Urea/BUN concentration)*

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