ABL90 FLEX PLUS Instructions for Use sw ver 3.4 March 2018

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... 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... 24 To get calculated values for FShunt and ctO2(a-v̄)... 26

Entering and editing data in the Patient identification screen... 26 The Patient identification screen...26 To change the report layout in the Patient identification screen... 27 To request patient data automatically when connected to a LIS/HIS system...27 To request patient data using Patient lookup...27 To edit data in the Patient identification screen... 28

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

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

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

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4.

Replacements and maintenance General warnings and cautions... 35 Types of consumables...35 To order products for use with your analyzer... 36 Replacement intervals for consumables and Inlet Connector Gasket...36

Replacements... 36 Solution Pack... 36 To see the Solution Pack status...36 To replace the Solution Pack... 37 Can a Solution Pack be used again?...38 Status logs... 39 To print Solution Pack status logs... 39 To export Solution Pack status logs... 39

Sensor Cassette... 39 To see the Sensor Cassette status... 39 To replace the Sensor Cassette... 39 Calibration frequency after a Sensor Cassette SC90 replacement ...40 Can a Sensor Cassette be used again?...40 Status logs... 41 To print Sensor Cassette status logs... 41 To export Sensor Cassette status logs...41

Thermal printer paper... 41 To replace the thermal printer paper...41 Protection of printed data... 42

Inlet Module... 42 To replace the Inlet Module... 42

Inlet Gasket Holder... 44 To replace the Inlet Gasket Holder...44

Inlet Probe... 45 To replace the Inlet Probe... 45

Inlet Connector Gasket... 47 To replace the Inlet Connector Gasket... 47

Maintenance... 49 Cleaning... 49 Cleaning - when is it necessary?... 49 To clean the inlet gasket... 50 To clean the touch screen... 50 To clean the analyzer exterior...50 To clean the QUALICHECK Opener/Adapter...51

Disinfecting... 51 Disinfection - when is it necessary?... 51 To disinfect the touch screen ... 51 To disinfect the analyzer exterior... 52 To disinfect the fluid transport system... 52

Battery... 52 To recharge the analyzer battery...52 To install and service the battery...52

Disposal... 53 To dispose of the analyzer...53

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Connecting peripherals... 53 To connect a USB external keyboard / mouse... 53 To connect a non-USB (PS/2) external keyboard or mouse... 53 To connect an external barcode reader...53 To connect the analyzer to a network...54 Reference... 54

5.

Quality control Overview of quality control management... 55 To find the status of QC measurements...55 Symbols that show the status of QCs...55

Automatic quality control management... 55 About automatic quality control management... 55 About system checks...56 Overview of automatic quality management... 56

Built-in QC... 57 About built-in QC measurements...57 Built-in QC measurement frequency... 58 To request an unscheduled built-in QC measurement... 58

Built-in QC results... 58 Status of built-in QC measurements... 58 To find a built-in QC result... 59 Symbols on built-in QC results...59 To see messages on built-in QC results... 59 To troubleshoot messages on built-in QC results...60

Quality control management done by operators... 60 Quality control management that can be done by operators...60

Ampoule-based QC measurements... 60 QC solutions for ampoule-based measurements... 60 How to get good ampoule-based QC measurement results... 61 To prepare a Radiometer QC ampoule for use... 61 To do a Radiometer ampoule-based QC measurement from the Analyzer status screen...63 To do an ampoule-based QC measurement from the start screen... 65 To edit QC identification data...66

Ampoule-based QC results... 67 Status of ampoule-based QC measurements...67 To find an ampoule-based QC result... 67 Symbols on ampoule-based QC results... 67 To see messages on ampoule-based QC results...67 To troubleshoot messages on results... 68

Calibration verification...68 About calibration verification... 68 Frequency of calibration verification... 68

Stage 1 - Analyzing different levels of control solution... 69 To prepare a Radiometer calibration-verification ampoule for use...69 To do a calibration-verification measurement... 70

Stage 2 - Using results to verify reportable ranges... 71 To find a calibration-verification measurement result... 71 Symbols on calibration-verification measurement results...72

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To temperature correct calibration-verification results based on Range+ QUALICHECK measurements... 72 To use temperature-corrected calibration-verification results...73 To temperature correct QUALICHECK7+ pH, pO2 and pCO2 control ranges ... 73 To age correct QUALICHECK7+ control ranges for cCrea ...74 To use corrected QUALICHECK7+ control ranges... 75 To temperature correct pH, pCO2 and pO2 results based on QUALICHECK7+ material...75 To age correct cCrea results based on QUALICHECK7+ material ... 76

Stage 3 - Changing reportable ranges... 77 To change the reportable range of parameters... 77

Reviewing QC statistics... 77 To find and print QC statistics... 77 QC plots... 78 To find a QC plot...78 To filter data from the Quality control log... 79 To see trends in QC results...79

WDC file export...79 About WDC... 79 To export WDC files...79

Analyzing QC solutions in other modes... 80 About analyzing QC solutions in other modes...80 To temperature correct results based on QUALICHECK5+ solutions... 80

6.

Calibration Overview of calibrations...81 Frequency of automatic calibrations...81 To find the status of calibrations... 82 Symbols that show the calibration status... 82

Automatic calibrations...83 To request an unscheduled calibration from the Analyzer status screen... 83 To request an unscheduled calibration from the menu... 83

Manual tHb calibrations... 83 To do a tHb calibration...83

Calibration results... 85 To find a calibration result... 85 Identification of calibrations in the Calibration log screen...85 Understanding calibration results... 86 To see messages on a calibration result... 86 To troubleshoot messages on results... 86

Reviewing calibration results... 86 To filter data from the Calibration log...86 To see trends in calibration results... 87 Status in the Calibration log screen... 87

7.

Troubleshooting Troubleshooting - when is it necessary?... 89 About guided troubleshooting... 89 To get out of Operator Action Needed mode...89 To get out of Troubleshooting needed mode...89

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To get out of Intervention Required mode... 89 Troubleshooting modes - causes... 89 To find and troubleshoot messages in the Analyzer status screen... 90 To flush the fluid transport system... 91

Operator actions requested in analyzer messages... 94 To request a tubing refill... 94 To request a liquid sensor adjustment...94 To request a pump calibration...94 To request a rinse... 94

Troubleshooting Analyzer messages... 94 To troubleshoot Analyzer messages... 94 Analyzer messages... 94

Activity log... 133 About the Activity log... 133 To troubleshoot messages in the Activity log... 133 To see activities in the Activity log... 133 To add a message to the Activity log...134 To filter activities from the Activity log... 134

Analyzer service... 134 For service... 134 To find the installation number (serial number) of the analyzer...134 To find the version of software installed...134

8.

Shutting down, moving and restarting the analyzer Shutdown... 135

Temporary shutdown of the analyzer... 135 When to do a temporary shutdown... 135 To do a temporary shutdown... 135

Long-term shutdown of the analyzer... 135 When to do a long-term shutdown...135 To do a long-term shutdown ... 136

Storing the analyzer...137 To store the analyzer... 137

Moving the analyzer... 138 To move an analyzer that has a charged battery...138 To move an analyzer that does not have a battery... 138

Restarting the analyzer... 138 To restart the analyzer after a temporary shutdown... 138 To restart the analyzer after a long-term shutdown...138

9.

Setup Setup menu structure...141 To print setups...142

Analyzer configuration... 142 Analyzer configuration... 142 To change the analyzer configuration... 142

Managing operators... 142 To select the logon procedure... 142 Access profiles...143

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To edit an access profile... 143 Anonymous use... 143 To set up anonymous use...144 Default operators... 144 To add an operator... 144 To remove an operator...145 To set a logoff time for all operators... 146 Centralized user management...146 To set up centralized user management... 146

Managing patient profiles... 147 Patient profiles log... 147 To see the data saved in a patient profile...147 To find a patient profile... 147 To edit a patient profile... 147 To add a new patient profile... 147 To delete a patient profile...147

Analyzer operations... 148 To lock the analyzer... 148 To unlock the analyzer... 148 To lock/unlock parameters for measurement...148 To show a message on the analyzer screen...148

Sample counter... 149 To see an overview of measurements and tests done on the analyzer...149 Sample counter... 149 To reset the counters in the User column...149

Analyzer settings... 149 To set up corrective actions on system messages... 149 To enable data to be scanned from barcodes...150 To create a heading for printed data... 150 To enable the screen saver... 150 To set the time and date... 150 To set the acoustic signals... 151 To mute all acoustic signals... 151 To change the screen language... 151 To select a regional setting... 151 To set the barometric pressure...151 To log all measurement activities...152

Analysis setup... 152 Analysis modes... 152 Syringe modes... 152 To edit a syringe mode...152 To create a new syringe mode...153 To remove a measurement mode... 154 To select a default measurement mode... 154 To select a specific patient report layout for an analysis mode... 154 To set up a calibration-verification mode... 155 To set up an ampoule QC mode...155 Capillary modes... 155 To edit a capillary mode... 155

Ranges and critical limits... 156 About ranges and critical limits... 156 About reference ranges...157

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Reference range of measured parameters...157 About critical limits...157 To set the limits for patient age groups... 157 To set up reference ranges and critical limits...158 About reportable ranges...158 To set up reportable ranges... 158 About range of indication... 159

Sample pre-registration... 159 About sample pre-registration...159 To set up sample pre-registration... 159

Sample age evaluation... 159 About sample age evaluation... 159 Maximum sample age... 160 To set a maximum sample age...160 Max sample age...160

Patient report layouts... 160 About patient report layouts... 160 To create a patient report layout... 161 To change a patient result layout...162 To create extra items for use in patient report layouts... 163 To select a patient report layout as default... 163 To automatically change the temperature units... 164 To edit a patient report layout...164 To create a patient report layout for FShunt and ctO2(a-v̄)... 165

Patient result settings... 165 To set up automatic printing of acid-base charts... 165 Approval and rejection of patient results... 166 To enable patient result approval/rejection... 166

Parameter settings... 166 To show the parameter bar...166 To hide the parameter bar... 166 To enable/disable a parameter... 166 To set up measuring units for parameters...167 To repress a parameter... 167 To suppress out-of-range results... 167 To fix the number of decimals used in blood-gas results... 167 To enable HbF corrections... 168 To enable the estimation of derived parameters... 168

Editing the slope and offset of a parameter... 168 Operator-defined corrections (offset and slope)... 168 Recommendations about samples to use... 169 Limits for slope and offset values... 170 To edit the offset and slope for a parameter...171

Calibration settings... 172 Details about calibration frequency... 172 To edit the calibration schedule... 173 To link the built-in QC schedule to the calibration schedule... 174 To set up corrective actions for overdue scheduled calibrations...174

Quality control... 174 Glossary of quality control terms... 174

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Registration of QC solutions... 175 Why is it necessary to register QC solutions?... 175 About registration of QC solutions... 175 To register a Radiometer QC solution for ampoule-based QC measurements...175 Data saved during registration of Radiometer QC solutions... 176 To register a non-Radiometer QC solution...177 Data saved during registration of non-Radiometer QC solutions... 177

Quality control solutions... 177 To set up the temperature field for QC measurements... 177

Scheduled QC measurements... 178 To schedule ampoule-based QC measurements... 178 To edit the schedule for ampoule-based QC measurements... 178 Built-in QC measurement frequency... 179 To edit the schedule for built-in QC measurements... 179 To request ampoule-based QC measurements after replacements... 181

Corrective actions on QC results... 181 To set up corrective action for errors in QC results... 181 To set up corrective actions for overdue scheduled QC measurements... 182 To apply operator-defined corrections to QC results... 182 To set up corrective action for errors in built-in QC measurements... 182

QC statistics... 183 To set up automatic print of built-in QC statistics... 183 Statistical factor...183 To set the statistical factor... 183

Westgard Rules... 183 About Westgard Rules...183 Types of Westgard Rule ...183 Description of the lines used in Westgard rule illustrations... 183 Westgard rules and corrective actions... 184 To set up and enable Westgard Rules... 185 To disable/enable Westgard rules... 186

RiLiBÄK rules... 186 About RiLiBÄK rules...186 To add a new RiLiBÄK rule... 186 To apply all RiLiBÄK rules... 187 To edit a RiLiBÄK rule... 187 To remove a RiLiBÄK rule... 188

Analyzer-specific control ranges... 188 About analyzer-specific control ranges... 188 How to establish analyzer-specific control ranges... 188 Stage 1: To do 20 ampoule-based QC measurements...189 Stage 2: To enable the use of fixed standard deviations... 189 Stage 3: To use the analyzer to change control ranges to analyzer-specific control ranges...189 To manually change control ranges to analyzer-specific control ranges... 190

Maintenance setup... 191 About mandatory and operator-defined activities...191

Mandatory maintenance activities... 191 Other activities... 191 To schedule other activities...191 To set up corrective action for overdue Other activities...192

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Operator-defined activities... 192 Operator activities...192 To set up an operator activity... 193 To set up corrective action for pending operator activities... 193 To delete an operator activity...193

Maintenance planning...193 To plan maintenance activities... 193

Replacement warnings... 194 To set up replacement warnings... 194

Note fields... 194 To create standard texts for use in Note fields... 194 To edit standard texts for use in Note fields... 194 To delete standard texts for use in Note fields... 194

Communications... 195 Data security...195 Live Connect... 195 To set up a LIS/HIS connection... 196 To set up a AQURE/RADIANCE connection... 196 Patient data from a LIS/HIS or AQURE/RADIANCE system... 196 To set up automatic requests for patient data... 197 To set up automatic transmission of data to a system... 197 To enable manual patient data requests using Patient lookup... 197 To access the RADIANCE system from the analyzer...198 To set up a QA Portal connection... 198

Printers... 198 To set up automatic printing... 198 To install an external printer for the analyzer... 198 To edit the name of a printer... 199

Data logs and archives... 199 About data logs and archived data logs... 199 To set up automatic archiving... 199 File format of exported data logs and archived data logs... 200 To export data logs...200 To export data from Archived data logs... 200 To create disc space by exporting and deleting archives... 200 To import archived data logs...201

Data backup and restoration... 201 Backup... 201 Destinations for backup data... 201 To schedule automatic backups... 201 To do a manual backup... 202 To restore data from a backup... 202

Saving and loading setups... 202 To save the setup...202 To load a setup... 202 To restore Radiometer default settings... 203

Radiometer default settings... 203 Operators and profiles - default settings...203 Alarm sound (acoustic signal) settings for events - default settings...204 Language - default setting...204 Analysis setup – default settings... 205

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Parameters - default settings... 206 Measurement units - default settings... 207 Calibration schedule - default settings...208 Quality control setups - default settings... 208 Replacement setups - default settings...209 Communication setup - default settings... 209 User-defined patient data items - default settings...210 Corrective actions – default settings... 210 Miscellaneous setup - default settings... 211 Printer setup - default settings...211 Automatic printing - default settings... 212 Automatic archiving - default settings... 212 Automatic backup - default setting... 212 Setups with no default settings... 212 References... 212

10.

Performance characteristics Measured parameters – definitions... 213

About performance characteristics... 214 Overview of performance characteristics... 214 Uncertainty in performance characteristics... 214 To convert an uncertainty at a 68 % confidence level... 215 Bias... 215 Repeatability and reproducibility... 216 Coefficient of variation (CV %)...216 Confidence intervals... 217 Total analytical error...217

About performance tests...217 Test conditions...217 Reference methods/materials... 218

Performance test results... 220 Rounding rules... 220 pH performance test results... 220 pCO2 performance test results... 221 pO2 performance test results... 222 cK+ performance test results... 224 cNa+ performance test results... 225 cCl– performance test results...225 cCa2+ performance test results... 227 cGlu performance test results... 228 pO2 levels - how they affect cGlu results... 233 cLac performance test results... 234 ctHb performance test results... 237 sO2 performance test results...238 FO2Hb performance test results... 239 FCOHb performance test results...240 FMetHb performance test results...242 FHHb performance test results...243 FHbF performance test results... 244 ctBil performance test results ... 245 ctBil external test results... 246

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cUrea performance test results... 248 cBUN performance test results... 249 cCrea performance test results... 249 Precision and bias of aqueous QC system – QUALICHECK7+... 250

Interference test results... 254 Interference tests... 254 pH/blood gas...255 Electrolytes... 255 Metabolites... 258 Oximetry parameters...272 ctBil sensitivity for MCHC variations... 281

Traceability... 282 Traceability to the primary standards at Radiometer...282 pH traceability... 282 pCO2 and pO2 traceability...282 cK+ and cNa+ traceability... 283 cCa2+ traceability... 283 cCl– traceability... 283 cGlu traceability...283 cLac traceability...283 ctHb traceability...284 Saturation – sO2 = 100 % – traceability... 284 Saturation – sO2 = 0 % – traceability... 284 FCOHb – normal value - traceability...284 FCOHb – 100 % - traceability... 284 FMetHb traceability... 285 FHbF traceability... 285 ctBil traceability... 285 cUrea/BUN traceability...285 cCrea traceability... 285 References... 285

11.

Derived and input parameters Parameter types... 289 Parameter symbols...289 Input parameters – definitions and acceptable values... 289 Derived parameters...290 Default values of parameters... 291

Definitions of derived parameters... 292 Acid-base derived parameters – definitions...292 Oximetry derived parameters – definitions... 293 Oxygen derived parameters - definitions... 293 Electrolyte derived parameters – definitions...295 Data necessary to derive electrolyte parameters... 295 Metabolite derived parameters – definitions... 295

Calculation of derived parameters... 296 Sample type...296 Units and symbols used in equations... 296 Units of derived parameters – metabolite parameters... 297

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Equations... 297 Equations for acid-base parameters... 297 pH(T) - equation 1... 297 cH+(T) - equation 2...297 pCO2(T) - equation 3... 297 cHCO3–(P) - equation 4...298 cBase(B) - equation 5...298 cBase(B,ox) - equation 6...298 cBase(Ecf) - equation 7... 298 cBase(Ecf,ox) - equation 8... 298 cHCO3–(P,st) - equation 9... 298 ctCO2(P) - equation 10... 299 ctCO2(B) - equation 11... 299 pH(st) - equation 12...299

Equations for electrolyte parameters... 299 Anion Gap, K+ equation 43... 299 Anion Gap - equation 44... 299 cCa2+(7.4) - equation 45... 299 Equations 46 and 47...300 mOsm - equation 48... 300

Equations for oxygen parameters... 300 pO2(T) - equation 14... 300 pO2(A) - equation 15... 301 pO2(A,T) - equation 16... 301 pO2(a)/FO2(I) - equation 17... 301 pO2(a,T)/ FO2(I) - equation 18... 301 p50 - equation 19... 301 p50(T) - equation 20... 302 p50(st) - equation 21... 302 pO2(A-a) - equation 22... 302 pO2(A-a,T) - equation 23... 303 pO2(a/A) - equation 24... 303 pO2(a/A,T) - equation 25... 303 pO2(x) or px - equation 26... 303 pO2(x,T) - equation 50... 303 ctO2 - equation 27... 304 ctO2(a-v̄) - equation 28... 304 BO2 - equation 29... 305 ctO2(x) or cx - equation 30... 305 ḊO2 - equation 31... 305 Q̇t - equation 32... 305 V̇O2 - equation 33... 306 FShunt - equation 34...306 FShunt(T) - equation 35... 306 RI - equation 36... 307 RI(T) - equation 37... 307 Qx - equation 38... 308 V(B) - equation 42... 308 VCO2/V(dry air) - equation 51... 308 VO2/V(dry air) - equation 52... 309

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Equations for oximetry parameters... 309 FHHb - equation 41... 309 FO2Hb - equation 40...309 sO2 - equation 39...309 Hct - equation 13... 309 FHbF - equation 49... 310

Equations for metabolite parameters... 310 GFR if AA - equation 53... 310 GFR if non AA - equation 54... 310 GFR if JP - equation 55... 310 GFR Schwartz - equation 56... 310 GFRmdrd AA - equation 57...311 GFRmdrd nonAA - equation 58...311 GFRckd AA - equation 59... 311 GFRckd nonAA - equation 60... 311 Urea/BUN-to-creatinine ratio - equation 61...311 Converting results to other units ... 311

Oxyhemoglobin dissociation curve...312 ODC equations... 312 The ODC reference position... 313 The ODC displacement...313 The actual ODC position...314 To determine the actual displacement... 315 Coordinates on the ODC...317 References... 317

12.

Principles of operation General construction... 319 Sensors... 319

General measurement principles... 319 Introduction... 319 Activity vs. concentration... 320 Fluid transport system... 320 Measurement process... 322 Rinse process... 322

Calibration... 322 Definition... 322 Frequency...322 Calibration solutions... 322

The calibration equation... 323 About the calibration equation... 323 Plotting a calibration line... 323

Sensitivity, status and drift... 323 Sensitivity...323 Status... 325 Drift... 325

Reference electrode...325 Background information - reference electrode...325 Purpose... 325 Fixed potential...325

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Use ... 326

Construction - reference electrode... 326 Construction...326

pH and electrolyte sensors... 326 Construction - pH and electrolyte sensors... 326 Construction...326

Measurement principles - pH and electrolyte sensors... 327 Potentiometric measurement principle... 327 Electrode chain... 327 Electrode chain potential... 328 Derived potential... 328 Ion-sensitive membrane... 328 Nernst equation... 328 Activity and concentration... 329

Calibration - pH and electrolyte sensors... 329 Calibrations of pH and electrolyte sensors... 329 Calculation of pH and electrolytes sensitivity...329

Measurement - pH and electrolyte sensors... 329 Calculation of pH and electrolyte values... 329 Sensor response stability... 330

pCO2 sensor... 330 Construction - pCO2 sensor... 330 Construction...330

Measurement principle - pCO2 sensor... 331 Electrode chain... 331 Electrode chain potential... 331 Measurement process in the pCO2 sensor... 331

Calibration - pCO2 sensor...332 Calibrations of the pCO2 sensor ...332 Calibration levels... 332 Calculation of pCO2 sensitivity... 332

Measurement - pCO2 sensor...333 Calculation of pCO2 values... 333 Sensor response stability... 333

pO2 sensor... 333 Measurement principle - pO2 sensor... 333 Optical system for pO2...333 Measurement sequence... 334 Calculations... 334

Calibration - pO2 sensor... 334 Overview of pO2 calibrations...334 Sensitivity...334 Status... 335

Measurement - pO2 sensor...335 Calculation of pO2 values... 335

Glu and Lac sensors... 336 Construction - Glu and Lac sensors... 336 Construction - Glu and Lac sensors...336 Zero current - Glu and Lac sensors... 336

Calibration - Glu and Lac sensors... 337 Calculation of sensitivity – Glu and Lac sensors... 337

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Measurement - Glu and Lac sensors... 337 Calculation of Glu and Lac values... 337 Sensor response stability of the glucose and lactate sensors... 337

Measurement principle - Glu and Lac sensors... 338 Amperometric measurement principle for Glu and Lac sensors... 338 Electrode chain – Glu and Lac sensors...338 Measurement process – Glu and Lac... 338

Creatinine sensors... 339 2-sensor configuration... 339 Construction - Creatinine sensors... 339 Zero current - cCrea... 340 Determination of analyte levels in the calibrators...340 Calculation of sensitivity – Creatinine...340 Calculation of cCrea values...341 Measurement process – creatinine...341 Electrode chain – creatinine...342 Sensor response stability of the creatinine sensors... 342

Urea/BUN sensors...342 Construction...342 Potentiometric measurement principle... 343 Electrode chain potential... 343 Derived potential... 343 Enzyme layer... 344 Ion-sensitive membrane... 344 Nernst equation... 344 Calibration of the urea/BUN sensor...344 Calculation of cUrea/BUN values... 344 Sensor response stability of the urea/BUN sensor... 345

ctHb and derivates... 345 Description of the optical system... 345 Measured parameters... 345 Construction...345 Measurement cycle...346 Lambert-Beer's law... 346 Absorbance... 347 Total absorbance...347 Continuous spectrum...347 Spectrum examples...348 Determining concentrations... 348 Matrix of constants...349

Calibration of the optical system... 349 Calibration materials... 349 Zero point... 349 Cuvette path length...349

Correcting for interferences...349 HbF versus HbA... 349 Deviation of results... 350 Detecting HbF...350 Correcting for HbF...350 Repressing spectra... 350 Residual spectrum...351

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Measurement and corrections... 351 Calculation of the values of the oximetry parameters... 351 Bilirubin...351 Restrictions ... 352 Corrections for ctHb... 352 Corrections for ctBil...353 References... 353

13.

Specifications Analyzer specifications... 355 Ranges of indication and reportable ranges...355 Measurement precision within specified ranges...357 Product specifications... 361 Environmental specifications...364 Power-supply cords... 365

Consumables specifications... 366 Solution Pack... 366 Function of the Solution Pack...366 Solution Pack specifications... 366

Sensor Cassette... 368 Function of the Sensor Cassette... 368 Sensor Cassette specifications... 368

14.

Graphical symbols Explanation of graphical symbols/icons... 371

15.

Ordering information Solution Packs – code numbers... 375 Sensor Cassettes – code numbers... 375 Spare parts and accessories - code numbers...376 Quality control products – code numbers...376 Recommended Radiometer sampling devices - code numbers...377 Power-supply cords - code numbers... 379

16.

Dialysis fluids - for non-clinical purposes About dialysis fluids...381 Purpose of the dialysis fluids measurement mode... 381 Warnings about analyzing dialysis fluid samples ... 381 To make sure dialysis fluid analyses do not affect analyzer performance... 382 To calculate the offset and slope corrections for dialysis fluid parameters... 382 To enter new offset and slope corrections for dialysis fluid parameters...383 To create a dialysis fluid mode... 383 To analyze a dialysis fluid sample... 384 To find a dialysis fluid analysis result... 385

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ABL90 FLEX PLUS: Instructions for use

Legal information Patents and trademarks... 387 Patents... 387 Trademarks... 387

Legal notices... 387 System performance... 387 Third-party software and trademarks... 387 Warranties and disclaimer... 387 Confidentiality... 388 Changes... 388 End-user license agreement with Microsoft... 388

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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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