RADIOMETER ABL800 FLEX Reference Manual
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RADIOMETER ABL800 FLEX Reference Manual

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See also: Operator's Manual
ABL800 FLEX
Reference
manual
Contents
1.
Potentiometric measuring principles
2.
Amperometric measuring principles
3.
Optical measuring principles
4.
User-defined corrections
5.
Performance specifications
6.
Parameters
7.
Solutions and gas mixtures
Index
Date of Issue

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Summary of Contents for RADIOMETER ABL800 FLEX

  • Page 1 Contents ABL800 FLEX Potentiometric measuring principles Amperometric measuring principles Optical measuring principles User-defined corrections Reference Performance specifications manual Parameters Solutions and gas mixtures Index Date of Issue...
  • Page 2 Radiometer are used, or if instrument repairs are not carried out by authorized service representatives. The instructions given in the Operator’s Manual for the ABL800 FLEX must be observed in order to ensure proper instrument performance, and to avoid electrical hazards.

  • Page 3: Table Of Contents

    Contents Potentiometric measuring principles ............1-1 Overview ......................1-1 General information ..................1-2 Reference electrode ..................1-8 pH electrode ....................1-9 electrode ....................1-14 Electrolyte electrodes ..................1-22 References ..................... 1-34 Amperometric measuring principles ............2-1 Overview ......................2-1 General information ..................2-2 electrode ....................
  • Page 4 Contents ABL800 FLEX Operator's Manual Overview ......................6-1 General information ..................6-2 Measured parameters..................6-5 Input parameters .................... 6-14 Derived parameters..................6-17 Units and numerical format of derived parameters ........6-22 List of equations .................... 6-27 Oxyhemoglobin dissociation curve (ODC) ........... 6-43 Conversion of units ..................

  • Page 5: Manual

    ABL800 FLEX Operator's Manual Contents Warnings/Cautions Throughout the manual, the descriptions may contain operational precautions and Definitions warnings. Notice Definition WARNING Warning alerts users to potential serious outcomes to themselves or the patient (such as death, injury, or serious adverse events).

  • Page 6: Potentiometric Measuring Principles

    1. Potentiometric measuring principles Overview Introduction This chapter describes the potentiometric measuring principles and the pH, pCO and electrolyte electrodes that are based on this principle. Contents This chapter contains the following topics. General information ..................Reference electrode..................pH electrode ..................... electrode ....................

  • Page 7: General Information

    1. Potentiometric measuring principles ABL800 FLEX Reference Manual General information The potential of an electrode chain is recorded using a voltmeter, and related to the Potentiometric method concentration of the sample (the Nernst equation). An electrode chain describes an electrical circuit consisting of a sample, electrode, reference electrode, voltmeter, membranes, and electrolyte solutions.
  • Page 8 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles General information, Continued Nernst equation charge on the ion (continued) −1 Faraday constant (96487 coulomb × mol activity of x The Nernst equation is rearranged to express the activity as a function of the potential E .
  • Page 9 1. Potentiometric measuring principles ABL800 FLEX Reference Manual General information, Continued The electrodes are active elements and must be calibrated regularly. Signals from Calibration the electrodes change because of, e.g., protein build-up, worn-out membranes, (continued) aging electrodes, etc. The responses from the electrodes when measuring on the calibrating solutions are checked to ensure that the amplified signals from the electrodes are converted to accurate values for an unknown sample.
  • Page 10 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles General information, Continued To describe the actual condition of the electrode, its calibration line is compared to Calibration line (continued) the calibration line of the theoretical electrode. Measured The theoretical electrode is...
  • Page 11 • Drift 2 – obtained after a 2-point calibration. The obtained drift values should not exceed the calibration drift tolerances. The drift tolerances can be changed in the Setup program, but Radiometer recommends using the default drift tolerances. Too narrow drift tolerances will cause electrode drift errors even for normal electrode fluctuations.
  • Page 12 The Chemical Reference Laboratory at Radiometer is responsible for the accuracy of the calibrating solutions. Traceability certificates for the individual solutions are enclosed in Chapter 7: Solutions and Gas Mixtures.

  • Page 13: Reference Electrode

    1. Potentiometric measuring principles ABL800 FLEX Reference Manual Reference electrode The reference electrode is used in the measurement of pH and electrolyte Description parameters and is located in the pH/Blood Gas module. The reference electrode maintains a stable, fixed potential against which other potential differences can be measured.

  • Page 14: Ph Electrode

    ABL800 FLEX Reference Manual 1. Potentiometric measuring principles pH electrode The pH electrode (E777) is a pH-sensitive glass electrode. The pH-sensitive glass Description membrane is located at the tip and seals the inner buffer solution with a constant and known pH.
  • Page 15 NOTE: Under normal circumstances, pH(Cal1)−pH(Cal1,prev) = 0. However in instances where the Cal 1 solution container has been replaced between two consecutive calibrations, pH(Cal1)−pH(Cal1,prev) ≠ 0. The default drift tolerances set by Radiometer for Drift 1 are ± 0.020. Drift 2 is calculated from the following equation: −...
  • Page 16 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles pH electrode, Continued The sample pH is calculated as follows: Measurement − E(pH,sample) E(pH,Cal1) pH(sample) = pH(Cal1) − × 61.5 Sens(pH) Corrections The measured pH value is then corrected for systematic deviations from the...
  • Page 17 1. Potentiometric measuring principles ABL800 FLEX Reference Manual pH electrode, Continued Corrections ABL8XX Mode Equation (continued) FLEX −0.216 35/25/15 FLEXMODE (message 870) 1.030 −0.216 (cont.) FLEXMODE (message 869) 1.030 30/20/10 0,9964 0.0150 −0.1880 1.025 −0.0035 FLEXMODE (no message) 1.0006 −0.1575 FLEXMODE (message 872) 1.0209...
  • Page 18 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles pH electrode, Continued Stability criteria The following stability criterion must be met to obtain a stable electrode response during 1- and 2-point calibration : − ≤ pH(sample, last) pH(sample, i) . pH(limit)

  • Page 19: Pco 2 Electrode

    1. Potentiometric measuring principles ABL800 FLEX Reference Manual electrode The p CO electrode (E788) is a combined pH and Ag/AgCl reference electrode Description mounted in a plastic jacket, which is filled with a bicarbonate electrolyte. Electrode contact The jacket is covered by a 20 µm silicone membrane...
  • Page 20 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles electrode, Continued The pH value is related to the partial pressure of CO in the sample by the Nernst equation (continued) following equation: α × where: = − log K , the equilibrium constant for the dissociation of carbonic acid in water α...
  • Page 21 1. Potentiometric measuring principles ABL800 FLEX Reference Manual electrode, Continued ,Gas1) Designation Standard potential of the p CO electrode with Gas 1 (continued) E(CO ,Gas1,prev) Potential of the p CO electrode from the previous measurement on Gas 1 δ difference between p CO (sample) from the first and last updatings.
  • Page 22 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles electrode, Continued Drift (continued) The default drift tolerances set by Radiometer are as follows: • for Drift 1 are ± 0.33 kPa (2.5 mmHg) • for Drift 2 are ± 0.67 kPa (5.0 mmHg)
  • Page 23 1. Potentiometric measuring principles ABL800 FLEX Reference Manual electrode, Continued Corrections - = barometric pressure in kPa blood samples (continued) = partial pressure of saturated water vapor (6.2751 kPa) = correction cut-off = correction factor Mode BL8XX FLEX 35/25/15 S195 -0.003573...
  • Page 24 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles electrode, Continued Corrections - blood samples (continued) ABL8XX Mode FLEX S165 -0.003573 1.1126 0.0051 -0.0000002 -0.003573 1.1126 0.0051 -0.0000002 1.000 -0.016 A, B -0.003573 1.1126 0.0051 -0.0000002 -0.003573 1.1126 0.0051 -0.0000002 1.013 0.010...
  • Page 25 1. Potentiometric measuring principles ABL800 FLEX Reference Manual electrode, Continued Stability criteria The following stability criterion must be met to obtain a stable electrode response during calibration: − ≤ p CO (sample, upd.last) (sample, upd.i) (limit) This criterion is valid for calibrations using Gas 1 and Gas 2 where: Parameter value from the last updating number...
  • Page 26 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles electrode, Continued Expired air samples: Stability criteria (continued) Measurement on an expired air sample is accepted if the following criterion is fulfilled: ⏐p CO (sample,upd.30) − p CO (sample,upd.24) ⏐≤ 0.40 kPa (3.0 mmHg) ⏐p CO...

  • Page 27: Electrolyte Electrodes

    1. Potentiometric measuring principles ABL800 FLEX Reference Manual Electrolyte electrodes Description Electrode contact The K electrode (E722) is an ion- selective electrode whose sensing element is a PVC membrane containing a potassium-neutral ion carrier. The ion- sensitive membrane is covered with a cellophane membrane in order to protect it from the samples.
  • Page 28 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles Electrolyte electrodes, Continued The Ca electrode (E733) is an ion- Description Electrode contact selective electrode whose sensing (continued) element is a PVC membrane containing a calcium-neutral ion carrier. The ion- sensitive membrane is covered with a cellophane membrane in order to protect it from the samples.
  • Page 29 1. Potentiometric measuring principles ABL800 FLEX Reference Manual Electrolyte electrodes, Continued The total potential across the electrode chain is a sum of the potential differences at Electrode chain potential each of the elements in the chain, all but one of which is known and constant.
  • Page 30 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles Electrolyte electrodes, Continued Cal 1 solution S1720 has the following nominal electrolyte concentrations: Calibration solution values 4.0 mmol/L c Na 145 mmol/L c Ca 1.25 mmol/L − 102 mmol/L c Cl Cal 2 solution S1730 has the following nominal electrolyte concentrations: 40.0 mmol/L...
  • Page 31 1. Potentiometric measuring principles ABL800 FLEX Reference Manual Electrolyte electrodes, Continued The sensitivity of the electrolyte electrodes is calculated from the following Sensitivity equations: K electrode − E(K,Cal1) E(K,Cal2) Sens(K) (fraction) K (Cal1) × 61.5 log K (Cal2 Na electrode −...
  • Page 32 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles Electrolyte electrodes, Continued Status Ca electrode − (continued) E(Ca, Cal1) (Ca, Cal1) × 30.75 (Cal1, nom) Status(Ca) mmol/L (Cal1) Cl electrode − E(Cl, Cal1) (Cl, Cal1) − × 61.5 (Cal1, nom) Status(Cl) mmol/L −...
  • Page 33 NOTE: If Cal 1 solution bottle has not been changed between two consecutive − calibrations, the cX(Cal1,prev) cX(Cal1) = 0, where X is the respective electrolyte ion. The default drift tolerances set by Radiometer are as follows: Electrode Drift 1 Tolerances Drift 2 Tolerances ± 0.2 mmol/L ±...
  • Page 34 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles Electrolyte electrodes, Continued The measured electrolyte concentration is then corrected for systematic deviations Corrections from the reference method by the following equations: Equation A: × X(sample,corr) X(sample) µ µ µ 195 L...
  • Page 35 1. Potentiometric measuring principles ABL800 FLEX Reference Manual Electrolyte electrodes, Continued Corrections Corrections for cNa (cont): (continued) ABL8XX Mode Equation FLEX S165 0.995 -3.00 1.01 1.80 A, B 1.03 -1.09 A, B *FM (no message) 0.995 -3.00 *FM (message 874) 1.030...
  • Page 36 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles Electrolyte electrodes, Continued Corrections Corrections for cCa (continued) ABL8XX Mode Equation FLEX 35/25/15 S195 1.004 -0.022 1.05 -0.004 A, B 1.08 -0.04 A, B *FM (no message) 1.004 -0.022 *FM (message 874) 1.08...
  • Page 37 1. Potentiometric measuring principles ABL800 FLEX Reference Manual Electrolyte electrodes, Continued Stability criteria The following stability criterion must be met to obtain a stable electrode response during calibration: − ≤ × X(Cal, upd.last) X(Cal, upd.i X(Cal, upd.last) This criterion is valid for calibrations using Cal 1 and Cal 2 solutions where: cX(Cal,upd.last) =...
  • Page 38 ABL800 FLEX Reference Manual 1. Potentiometric measuring principles Electrolyte electrodes, Continued Stability criteria Constant for the stability criterion; it equals to: (continued) − = 0.012; Na = 0.012; Ca = 0.022; Cl = 0.012 Constant used indicates the concentration of the...

  • Page 39: References

    1. Potentiometric measuring principles ABL800 FLEX Reference Manual References Linnet N. pH measurements in theory and practice. 1 ed. Copenhagen: List of references Radiometer Medical A/S, 1970. 1-34...

  • Page 40: Amperometric Measuring Principles

    2. Amperometric measuring principles Overview Introduction This chapter describes the amperometric measuring principles and the pO metabolite electrodes that are based on this principle. Contents This chapter contains the following topics. General information ..................electrode....................Metabolite electrodes ..................2-12...

  • Page 41: General Information

    2. Amperometric measuring principles ABL800 FLEX Reference Manual General information The magnitude of an electrical current flowing through an electrode chain, which Amperometric method is in turn proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain...
  • Page 42 ABL800 FLEX Reference Manual 2. Amperometric measuring principles General information, Continued The membrane is selective to the species A, allowing no other species but it to pass Amperometric method through from the sample into the electrolyte solution. (continued) As an appropriate potential is applied across the electrodes, the species A is reduced at the cathode according to the following reaction: −...

  • Page 43: Po 2 Electrode

    2. Amperometric measuring principles ABL800 FLEX Reference Manual electrode The pO electrode is an amperometric electrode which consists of a silver anode, Description platinum cathode and Ag/AgCl reference band, all protected by an electrode jacket which is filled with electrolyte solution. At the tip of the electrode jacket an oxygen-permeable membrane protects the Pt cathode from protein contamination and is covered on the inner side with Pt-black.
  • Page 44 ABL800 FLEX Reference Manual 2. Amperometric measuring principles electrode, Continued The Ag ions are released into the electrolyte solution where they react with the Description − (continued) ions present, producing AgCl which is insoluble and forms a layer on the silver rod: −...
  • Page 45 Drift 2( O O gas2 Sens( O prev The default drift tolerances set by Radiometer are ± 0.80 kPa (6.0 mmHg) for Drift 1 and Drift 2. The Drift tolerances can, however, be user-defined in the Setup program. Continued on next page...
  • Page 46 ABL800 FLEX Reference Manual 2. Amperometric measuring principles electrode, Continued The pO value for a sample is calculated from the following equations: Measurement − sample, upd.i) gas2, prev × (sample, upd.i) Sens( Constant K describes the gas/liquid relationship for the electrode.
  • Page 47 2. Amperometric measuring principles ABL800 FLEX Reference Manual electrode, Continued Gas/liquid relationship : Corrections - blood samples is a constant that describes the gas/liquid relationship for the electrode. The constant is defined as follows: ⎛ ⎞ Sens ⎜ ⎟ −...
  • Page 48 ABL800 FLEX Reference Manual 2. Amperometric measuring principles electrode, Continued Corrections – blood samples (continued) Mode FLEX 35/25/ S195 -2.30300 5.96942 0.83281 -6.07310 1.30565 1.020 -0.200 -2.30300 5.96942 0.83281 -6.07310 1.30565 0.9965 -0.0254 -2.1199 4.7210 -1.0156 -4.2974 1.1035 *FM (no message) -2.30300...
  • Page 49 2. Amperometric measuring principles ABL800 FLEX Reference Manual electrode, Continued The pO measured from the sample is then corrected for systematic deviations Corrections - expired air from the reference method using the following equation: samples × × − (sample, corr)
  • Page 50 ABL800 FLEX Reference Manual 2. Amperometric measuring principles electrode, Continued The following stability criteria must be met in order to obtain a stable electrode Stability criteria (continued) response during measurement : δ=|pO (sample,upd.30) − pO (sample,upd.1)| For δ Criterion ≤ 2.66 kPa −...

  • Page 51: Metabolite Electrodes

    2. Amperometric measuring principles ABL800 FLEX Reference Manual Metabolite electrodes Description The glucose electrode (E7066) and the lactate electrode (E7077) have similar Electrode contact construction described below. The electrode consists of a silver cathode and a platinum anode. The electrode is protected by an electrode...
  • Page 52 ABL800 FLEX Reference Manual 2. Amperometric measuring principles Metabolite electrodes, Continued Description − → 2H + 2e (continued) When a potential is applied to the electrode chain, the oxidation of H produces an electrical current proportional to the amount of H , which in turn is directly related to the amount of glucose or lactate.
  • Page 53 2. Amperometric measuring principles ABL800 FLEX Reference Manual Metabolite electrodes, Continued • The baseline is extrapolated thoughout the whole electrode calibration or sample Zero current (continued) measurement period, and represents the zero current time function. • The I baseline is used to determine the sensitivity of the metabolite electrode.
  • Page 54 ABL800 FLEX Reference Manual 2. Amperometric measuring principles Metabolite electrodes, Continued The sensitivities of the metabolite electrodes are calculated by measuring the Sensitivity current on Calibration Solution 1 (Cal 1) and then correcting for the zero current using the extrapolated I baseline.
  • Page 55 = Extrapolated final zero current value of the metabolite electrode measured at the time of the last updating. The default drift tolerances set by Radiometer for the metabolite electrodes are: ± 0.5 mM for the glucose electrode ± 0.2 mM for the lactate electrode.
  • Page 56 ABL800 FLEX Reference Manual 2. Amperometric measuring principles Metabolite electrodes, Continued The glucose/lactate concentration in a sample is calculated from the following Measurement equation: − I(sample) (final) X(sample) Sens where: I(sample) = Current of the metabolite electrode measured on the sample.
  • Page 57 2. Amperometric measuring principles ABL800 FLEX Reference Manual Metabolite electrodes, Continued Corrections Corrections for cGlu : (continued) ABL8XX Mode Equation FLEX 35/25/15 S195 0.94 1.00 A, B 1.06 A, B 1.16 A, B *FM (no message) 0.94 *FM (message 874) 1.06...
  • Page 58 ABL800 FLEX Reference Manual 2. Amperometric measuring principles Metabolite electrodes, Continued Corrections ABL8XX Mode Equation (continued) FLEX S165 0.97 -0.04 1.03 0.03 A, B 1.03 0.18 A, B 1.13 0.05 A, B *FM (no message) 0.97 -0.04 *FM (message 874) 1.03...
  • Page 59 2. Amperometric measuring principles ABL800 FLEX Reference Manual Metabolite electrodes, Continued Stability criteria τ = Should be less than or equal to 50, (continued) − I(Cal upd.1) I(Cal upd.11) − I(Cal upd.11) I(Cal upd.21) should be negative or equal zero.
  • Page 60 ABL800 FLEX Reference Manual 2. Amperometric measuring principles Metabolite electrodes, Continued If all the criteria below are fulfilled, then the result of the measurement will be Stability criteria (continued) marked with an interference error. I(sample, upd.30) I(sample, upd.23) ≥ I(sample, upd.16...
  • Page 61 3. Optical measuring principles Overview Introduction This chapter describes the optical system, its construction, and the measuring method used. Contents This chapter contains the following topics. Optical system....................Correcting for interferences ................Measurement and corrections ................References ......................3-14...

  • Page 62: Optical Measuring Principles

    3. Optical measuring principles ABL800 FLEX Reference Manual Optical system The optical system of the ABL800 FLEX analyzer is designed to measure the Measured parameters following parameters: Parameter Description ctHb concentration of total hemoglobin oxygen saturation fraction of oxyhemoglobin FCOHb...

  • Page 63: Optical System

    ABL800 FLEX Reference Manual 3. Optical measuring principles Optical system, Continued The method used in the analyzer's optical system is visible absorption Construction (continued) spectroscopy. Step Description The blood sample is transported to the cuvette positioned in the hemolyzer unit. The temperature of the cuvette is regulated to 37 1 µL of the sample is ultrasonically hemolyzed in the cuvette at a...
  • Page 64 3. Optical measuring principles ABL800 FLEX Reference Manual Optical system, Continued Absorption spectroscopy is based on Lambert-Beer's law which states that the Lambert-Beer’s measured absorbance for a single compound is directly proportional to the concentration of the compound and the length of the light path through the sample [1]: ε...
  • Page 65 ABL800 FLEX Reference Manual 3. Optical measuring principles Optical system, Continued λ Continuous can be depicted graphically as a function of wavelength, and if the total spectrum differences between the wavelengths are small enough, a continuous spectrum is produced. EXAMPLES: The figure below shows three spectra;...
  • Page 66 3. Optical measuring principles ABL800 FLEX Reference Manual Optical system, Continued In the spectrum taken of a sample, the absorption recorded at each wavelength Determining concentrations contains contributions from each of the compounds in the sample. The task then is to determine the magnitude of that contribution and thereby the concentration of each compound in the sample.

  • Page 67: Correcting For Interferences

    0 to 3 months, as well as adults suffering from thalassemia, to take into account this difference [ 3 ] . The ABL800 FLEX analyzers automatically correct for HbF. The diagram below shows the transition from fetal hemoglobin to adult hemoglobin [ 4 ] .
  • Page 68 The optical system in the ABL800 FLEX analyzers compensates for the most likely interfering substances by repressing their spectra. The interference from following substances the analyzer compensates for when...

  • Page 69: Measurement And Corrections

    ABL800 FLEX Reference Manual 3. Optical measuring principles Measurement and corrections The oximetry parameters are calculated as follows: Oximetry parameters Parameter Equation = c O c tHb(meas) Hb + c COHb + c HHb + c MetHb O Hb ceHb = cHHb + cO...
  • Page 70 3. Optical measuring principles ABL800 FLEX Reference Manual Measurement and corrections, Continued Bilirubin 0 0301 × Hct(calc) (continued) g / dL For further details on Hct(calc) please refer to Interference Tests and the explanation of MCHC (Mean Corpuscular Hemoglobin Concentration) in chapter 5 in this manual.
  • Page 71 ABL800 FLEX Reference Manual 3. Optical measuring principles Measurement and corrections, Continued The uncorrected hemoglobin concentration, ctHb(sample), measured on capillary Corrections for or syringe samples is corrected as follows: ctHb Equation A: tHb(sample tHb(sample corr) where: ctHb(sample,corr) corrected ctHb Analyzer-dependent constant determined at tHb...
  • Page 72 3. Optical measuring principles ABL800 FLEX Reference Manual Measurement and corrections, Continued Corrections for ABL8XX Mode Equation ctHb (continued) FLEX 30/20/10 1.0050 0.9220 C35 OXI 0.9570 *FM (no message) 0.9570 *FM (message 872) 0.9490 *FM (message 871) 0.9440 *FM (message 870) 0.9230...
  • Page 73 ABL800 FLEX Reference Manual 3. Optical measuring principles Measurement and corrections, Continued Corrections for ABL8XX Mode Equation ctBil (continued) 1.0050 S195 0.9320 1.0000 0.9320 0.8640 C35oxi 0.9160 *FM (no message) 0.9900 *FM (message 874) *FM (message 873) *FM (message 872)

  • Page 74: References

    3. Optical measuring principles ABL800 FLEX Reference Manual References The list of the references for Chapter 3, The Optical Measuring Principles: List of references 1. Ewing GW. Instrumental methods of chemical analysis. 5 ed. McGraw-Hill, 1985. 2. Martens H. Multivariate calibration: quantitative interpretation of non-selective chemical data.

  • Page 75: User-Defined Corrections

    4. User-defined corrections Overview Introduction This chapter describes the basis of the user-defined corrections available for all the measured parameters. Contents This chapter contains the following topics. General information ..................Correction factors for oximetry parameters and bilirubin........ Electrolyte and metabolite parameters .............

  • Page 76: General Information

    4. User-defined corrections ABL800 FLEX Reference Manual General information User-defined corrections are most commonly implemented in situations where the Purpose of use values measured for a particular parameter by two or more analyzers, deviate consistently from each other. NOTE: Since the performance of all analyzers is tested as described in Chapter...
  • Page 77 ABL800 FLEX Reference Manual 4. User-defined corrections General information, Continued The slope/offset for each parameter are configured in the Parameters Setup under Entering user-defined General Setup. User-corrected values are marked with a “*” after the result. corrections NOTE: The user-defined corrections will be applied to measurements on QC solution unless the "Apply parameter corrections to QC"...

  • Page 78: Correction Factors For Oximetry Parameters And Bilirubin

    NOTE: In order to define the corrections accurately, the measurements of the oximetry parameters and bilirubin on the ABL800 FLEX analyzers should be made without any entered corrections. To avoid truncation errors from an enabled “Out of range suppression” function it is important to disable the function.
  • Page 79 Description Units Fraction Sample Radiometer recommends that ctHb in the adult samples (with FHbF = 0) and fetal samples (with high FHbF) is set to ≈ 15 ≈ 100 %, and pH ≈ 7.4. g/dL (9.3 mmol/L), sO The “Correction for HbF levels less than 20 %” function should be enabled in order to have the FHbF value displayed for the adult sample.
  • Page 80 µmol/L Units Sample Radiometer recommends that human plasma or serum is used with pH ≈ 7.4 (the analyzer reading). Zero point sample could be adult sample (ctBil ≈ 0 µmol/L) and maximum point could be an unconjugated bilirubin sample with ctBil ≈ 300 - 400 µmol/L.

  • Page 81: Electrolyte And Metabolite Parameters

    • A series of measurements that cover the entire measuring range should be performed. • The measurements should be made simultaneously on the ABL800 FLEX and reference analyzers, and samples must be handled correctly. • The slope and the offset must be calculated. The user may, for example, make a linear correlation between the values measured on the ABL800 FLEX and the reference analyzers, using the ABL800 FLEX as an independent variable.
  • Page 82 4. User-defined corrections ABL800 FLEX Reference Manual Electrolyte and metabolite parameters, Continued The Radiometer default values for the electrolyte and metabolite parameters must Resetting corrections to be reset manually by the user to 1.000 for each parameter via the Parameters default values Setup screen.

  • Page 83: Performance Characteristics

    ABL800 FLEX Reference Manual 5. Performance characteristics 5. Performance characteristics Overview Introduction This chapter describes performance characteristics for each measured parameter and test conditions to obtain them. Contents This chapter contains the following topics. Definition of terms and test conditions ............

  • Page 84: Definition Of Terms And Test Conditions

    Performance specifications of the ABL800 FLEX analyzers are described, using the following: • Bias = the mean difference between the ABL800 FLEX and the primary reference methods. • Bias = the mean difference between the ABL800 FLEX and the ABL735.
  • Page 85 ABL800 FLEX Reference Manual 5. Performance characteristics Definition of terms and test conditions, Continued Reproducibility Reproducibility is obtained from repeated measurements within several days using: • Random instrument • Random sample • Random operators. Reproducibility for each level is pooled for all test instruments and test days.
  • Page 86 Relative humidity: 30 – 50 %. • The solutions used in the performance tests are those recommended by NOTES: Radiometer. Performances using other solutions cannot be guaranteed. • The performance tests are performed under conditions where the analyzers are not influenced by electromagnetic fields.

  • Page 87: Performance Test Results - Chart Description

    ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – chart description Tests were performed in the following modes: Modes Mode Syringe Capillary Macro S195, S165 FLEXMODE ABL835 (no message) FLEXMODE ABL805 (no message) Micro S95, S85 C95, C85, C55, C35 OXI, C35 MET;...
  • Page 88 Chart Description x - axis The ABL800 FLEX mean value. y - axis Repeatability in %; repeatability for pH in pH units. Repeatability in macromodes. Repeatability in micromodes.
  • Page 89 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – chart description, Continued The number of measurements in macro- and micromodes, and the total number of Number of measurements measurements during the test is listed below: Parameter Total macro...

  • Page 90: Performance Test Results - Ph

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - pH Capillary-type glass pH electrode with a saturated calomel reference electrode and Primary a liquid junction saturated with KCl (BMS™ Mk2) [1,2]. reference method The calibration standards are traceable to the Primary Reference Standards for pH.
  • Page 91 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - pH, Continued Repeatability is presented by the following chart: Repeatability Repeatability (pH) ABL800 FLEX Total variation is presented by the following chart: Total variation Total variation (pH) ABL735...

  • Page 92: Performance Test Results - Pco

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results – pCO Tonometry [3]. Primary reference The gases used for tonometry are traceable to NIST certified Standard Reference method Materials. Bias The FLEXMODE on the ABL805/30/35 analyzers was tested: (mmHg) Bias -0.11...
  • Page 93 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – pCO Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmHg) Total variation is presented by the following chart: Total variation Total variation (%) ABL735 (mmHg)
  • Page 94 0.50 0.35 0.79 1.00 0.70 0.40 1.10 1.44 1.00 1.10 3.07 3.41 * The Expired air mode is unchanged in the ABL800 FLEX analyzers compared to the ABL700 Series and, consequently was not re-tested for the ABL800 FLEX analyzers. 5-12...

  • Page 95: Performance Test Results – Po 2

    ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – pO Tonometry [3]. Primary reference The gases used for tonometry are traceable to NIST certified Standard Reference method Materials. Bias The FLEXMODE on the ABL805/30/35 analyzers was tested: (mmHg) Bias 0.47...

  • Page 96: Performance Test Results - Po

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results – pO Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL835 (mmHg) Total variation Total variation is presented by the following chart: Total variation (%) ABL735 (mmHg)
  • Page 97 Bias and imprecision – expired air samples , mmHg Bias ABL835/30/25/20/15/10/05 −0.4 −0.9 Imprecision: mmHg 15 ABL700 Series and ABL800 FLEX analyzers are tested over three days for all levels. Bias is determined against certified gases at sea level. 5-15...

  • Page 98: Performance Test Results - Ck

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results – cK NIST certified Standard Reference Material SRM 909b (human serum). Primary reference methods Bias The FLEXMODE on the ABL805/35 analyzers was tested using SRM 909b: (mmol/L) Bias 3.424 -0.03 6.278...
  • Page 99 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – cK Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmol)L) Total variation Total variation is presented by the following chart: Total variation (%) ABL735 (mmol/L)

  • Page 100: Performance Test Results - Cna

    ABL800 FLEX Reference Manual Performance test results – cNa NIST certified Standard Reference Material SRM 909b (human serum) and Primary reference Radiometer specified standard serum material (specified using flame photometry). method Bias The FLEXMODE on the ABL805/35 analyzers was tested: (mmol/L) Bias 120.76*...
  • Page 101 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – cNa Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmol/L) Total variation Total variation is presented by the following chart: Total variation (%) ABL735 (mmol/L)

  • Page 102: Performance Test Results - Ccl

    5. Performance characteristics ABL800 FLEX Reference Manual – Performance test results – cCl NIST certified Standard Reference Material SRM 909b (human serum). Primary reference method Bias The FLEXMODE on the ABL805/35 analyzers was tested using SRM 909b: – (mmol/L) Bias 89.11...
  • Page 103 ABL800 FLEX Reference Manual 5. Performance characteristics – Performance test results – cCl Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmol/L) Total variation Total variation is presented by the following chart: Total variation (%)

  • Page 104: Performance Test Results - Cca

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results – cCa The calcium transfer standards were used. These are traceable to NIST SRM915 Primary and have an ionic strength of 160.0 mmol per kg of water and pH 7.40 at 37 °C, reference using 1 mmol/L (37 °C) HEPES buffer.
  • Page 105 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – cCa Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmol/L) Total variation Total variation is presented by the following chart: Total variation (%) ABL735 (mmol/L)

  • Page 106: Performance Test Results - Cglu

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results – cGlu Spectrophotometry, using the hexokinase (HK) method recommended by NCCLS Primary [5], measured on serum. reference method Bias The FLEXMODE on the ABL805/35 analyzers was tested: cGlu(mmol/L) Bias 0.08 0.03...
  • Page 107 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – cGlu, Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmol/L) Total variation Total variation is presented by the following chart: Total variation (%) ABL735 (mmol/L)

  • Page 108: Performance Test Results - Clac

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results – cLac Spectrophotometry using a lactate dehydrogenase (LDH) method, measured on Primary serum [10]. reference methods Bias The FLEXMODE on the ABL805/35 analyzers was tested: cLac (mmol/L) Bias 0.36 -0.08 2.06...
  • Page 109 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – cLac, Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmol/L) Total variation is presented by the following chart: Total variation Total variation (%) ABL735 (mmol/L)

  • Page 110: Performance Test Results - Cthb

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results – ctHb HiCN method recommended by NCCLS [6]. Primary reference method Bias The FLEXMODE on the ABL830/35 analyzers was tested: ctHb (mmol/L) Bias 15 (SAT0) 0.32 7 (SAT100) 0.04 15 (SAT100) 0.37...
  • Page 111 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results – ctHb, Continued Repeatability is presented by the following chart: Repeatability Repeatability (%) ABL800 FLEX (mmol/L) Total variation Total variation is presented by the following chart: Total variation (%) ABL735 (mmol/L)

  • Page 112: Performance Test Results - Oximetry

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - oximetry The optical system is unchanged in the ABL800 FLEX analyzers compared to the Explanation ABL700 Series. Test of ctHb on the ABL800 FLEX analyzers has been conducted (results given on pages 5-29 to 5-30). As the other oximetry parameters (sO Hb, FCOHb, FMetHb, FHHb, FHbF) are derived from ctHb, these parameters have not been re-tested;...
  • Page 113 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - oximetry, Continued Test conditions Test Description for oximetry parameters Verification 6-10 ABL700 Series analyzers are tested over at least (continued) 2 days for all levels. Bias for the given mode is calculated as difference compared to the C195 µL...
  • Page 114 5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - oximetry, Continued Bias: macromodes ABL835/25/15 ABL830/20/10 ctHb (g/dL) S195 −0.02 0.00 0.05 0.01 0.22 −0.08 0.01 0.00 −0.29 0.00 * FM = FLEXMODE (no message) corresponding to C195 mode on the ABL735/25/15.
  • Page 115 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - oximetry, Continued Bias: Hb - macromodes ABL835/25 ABL830/20 ctHb (g/dL) Hb (%) S195 −0.04 −0.02 0.00 −0.07 −0.03 −0.15 −0.05 * FM = FLEXMODE (no message) Imprecision: ctHb (g/dL) 0.05...
  • Page 116 5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - oximetry, Continued Imprecision: Hb - micromodes ctHb (g/dL) Hb (%) (continued) 0.05 0.05 0.25 0.30 0.25 0.20 0.50 0.60 0.15 0.15 0.45 0.50 0.10 0.10 0.40 0.45 FCOHb -...
  • Page 117 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - oximetry, Continued FCOHb – Bias: micromodes FCOHb ABL830/20 (continued) ctHb (g/dL) FCOHb (%) −0.02 0.08 0.08 * FM = FLEXMODE (no message) Imprecision: ctHb (g/dL) FCOHb (%) 0.05 0.10 0.35...
  • Page 118 5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - oximetry, Continued Bias: FMetHb micromodes FMetHb ABL835/25 ctHb FMetHb (g/dL) 0.13 0.14 0.06 0.16 0.14 FMetHb ABL830/20 ctHb (g/dL) FMetHb (%) 0.13 0.16 0.14 * FM = FLEXMODE (no message)
  • Page 119 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - oximetry, Continued Bias: FHHb - micromodes FHHb ABL835/25 ABL830/20 ctHb FHHb (g/dL) 0.09 0.15 0.10 0.10 * FM = FLEXMODE (no message) Imprecision: ctHb (g/dL) FHHb (%) 0.05 0.10 0.30...
  • Page 120 5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - oximetry, Continued Bias (micromodes): FHbF – adult blood FHbF ABL835 ABL830 (continued) ctHb FHbF (g/dL) * FM = FLEXMODE (no message) Imprecision (micromodes): ctHb (g/dL) FHbF (%) NOTES: a, b.
  • Page 121 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - oximetry, Continued FHbF – fetal Bias (micromodes): blood FHbF ABL835 ABL830 (continued) ctHb FHbF (g/dL) * FM = FLEXMODE (no message) Imprecision (macromodes): FHbF (%) ctHb (g/dL) NOTES: a, b.

  • Page 122: Performance Test Results - Bilirubin

    5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - bilirubin As the optical system is unchanged in the ABL800 FLEX analyzers compared to Explanation the ABL700 Series, the specifications for bilirubin have not been re-established. Field test results The ABL735/30 performance specifications for bilirubin were made as a field test the purpose of which was to optimize bilirubin algorithm for neonatal blood samples.
  • Page 123 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - bilirubin, Continued The field test results are given below. Field test results (continued) Pos. Field test Type Slope Inter- Range place µmol/L µmol/L cept µmol/L Plasma, 1.026 0.9914 18 – 258 neonatal 0.986...
  • Page 124 5. Performance characteristics ABL800 FLEX Reference Manual Performance test results - bilirubin, Continued Data set position 9 from regression table. Regression and Bland-Altman plot y = 1.0572x - 1.6119 = 0.9819 Syx=12.0 Hitachi, NIST Actual field test from a neonatal critical care hospital using whole blood. Values are in µmol/L.
  • Page 125 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - bilirubin, Continued The following parameters are used to describe performance of the ABL835/30 Imprecision parameters analyzers for bilirubin measurements. Repeatability. Measurement short time interval variation on the same sample.
  • Page 126 200 µmol/L is interpolated from the measured specifications at 0 and 400 µmol/L. The performance specifications apply to measurements performed using CLINITUBES with clot catchers and mixing wire from Radiometer. References 1. Fraser CG. The application of theoretical goals based on biological variation data in proficiency testing.
  • Page 127 ABL800 FLEX Reference Manual 5. Performance characteristics Performance test results - bilirubin, Continued 3. Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications References (continued) for the imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J CLin Chem Clin Biochem 1992; 30: 311-17.

  • Page 128: Additional Information About Flexmode

    • Two different parameter profiles can be reported for the same sample volume as the sample volume intervals overlap one another. See the ABL800 FLEX Operator’s Manual, chapter 4, page 4-3, for an overview of sample volume intervals and parameter profiles.

  • Page 129: Interference Tests

    ABL800 FLEX Reference Manual 5. Performance characteristics Interference tests The following interference results are found for the pH and blood gas electrodes: pH/blood gas Substance Test Conc. Interference on pO Electrode Halothane 5 % increased sensitivity Intralipid (20 % solution) in a concentration greater than 4 % (the final Intralipid level being 0.8 %) will give interference on pH measurements.
  • Page 130 5. Performance characteristics ABL800 FLEX Reference Manual Interference tests, Continued Electrolytes Interference on… (continued) − Substance Test Conc. (4 mmol/L (150 mmol/L (1.25 mmol/L (110 mmol/L level) level) level) level) Ascorbic acid mmol/L pH ≤ 7.2 −1 0.01 pH ≥ 7.6 −0.01...
  • Page 131 ABL800 FLEX Reference Manual 5. Performance characteristics Interference tests, Continued Metabolites Interference on … (continued) cGlucose cLactate Substance Test Conc. (4.0 mmol/L level) (1.5 mmol/L level) (mmol/L) Glycolic acid Interference <⎜0.1⎜ Heparin 8000 IU/dL <⎜0.1⎜ <⎜0.1⎜ Ibuprofen <⎜0.1⎜ <⎜0.1⎜ Intralipid <⎜0.1⎜...
  • Page 132 5. Performance characteristics ABL800 FLEX Reference Manual Interference tests, Continued The substances against which the oximetry parameters (ctHb, sO , FO Oximetry parameters FCOHb, FMetHb, FHHb, FHbF) and ctBil were tested for interference are given in the table below: (SAT100 blood reference test sample: ctHb=15 g/dL, sO =100 %, FCOHb=0.7 %,...
  • Page 133 ABL800 FLEX Reference Manual 5. Performance characteristics Interference tests, Continued The process of HbF correction introduces additional noise compared to measure- Contribution to imprecision ment on adult samples. The following tables list the extra contribution which must specifications be added geometrically to the imprecision specifications for adult samples in order...
  • Page 134 5. Performance characteristics ABL800 FLEX Reference Manual Interference tests, Continued FHbF sensitivity F HbF is sensitive to pH deviations from the nominal value of pH = 7.4. If pH is for pH changes converted into c H (hydrogen ion concentration), the relationship between the...
  • Page 135 ABL800 FLEX Reference Manual 5. Performance characteristics Interference tests, Continued ctBil sensitivity Subjects MCHC MCHC mean, g/L 95 % range, for MCHC mean 95 % range variations (continued) Adults 0.47 0.39 - 0.55 310 - 370 Women Adults 0.42 0.36 - 0.48...
  • Page 136 5. Performance characteristics ABL800 FLEX Reference Manual Interference tests, Continued ∆c − ctBil sensitivity tBil 0.58 = − × And ∆ctBil = 0.071 x 400 = 28 µmol/L. 0 071 for MCHC − tBil variations If the reference value for Hct is known, it is possible to correct the displayed ctBil...

  • Page 137: References

    ABL800 FLEX Reference Manual 5. Performance characteristics References Kristensen HB, Salomon A, Kokholm G. International pH scales and List of references certification of pH. Definition of pH scales, standard reference values, measurement of pH and related terminology (Recommendations 1994). Pure and Appl Chem 1985;...

  • Page 138: Parameters

    6. Parameters Overview The measured, input, and derived parameters are described in this chapter. Introduction This chapter contains the following topics. Contents General information ..................Measured parameters ..................Input parameters....................6-14 Derived parameters ..................6-17 Units and numerical format of derived parameters .......... 6-22 List of equations....................

  • Page 139: General Information

    6. Parameters ABL800 FLEX Reference Manual General information The Deep Picture developed by Radiometer [1], (visit our website www.deep- The Deep picture.com) expands traditional pH and blood gas analysis by evaluating the Picture capability of arterial blood to carry sufficient oxygen to tissues and to release it. It...
  • Page 140 ABL800 FLEX Reference Manual 6. Parameters General information, Continued Symbols 3. (System) Specification of the system B for blood (continued) P for plasma a for arterial blood – for mixed venous blood A for alveolar air T for patient temperature...
  • Page 141 6. Parameters ABL800 FLEX Reference Manual General information, Continued Derived parameters are calculated according to the equations stated. Derived parameters If… Then… the required measured or input default values are used, unless a measured values are unknown parameter does not have a value or is outside the measuring range.

  • Page 142: Measured Parameters

    ABL800 FLEX Reference Manual 6. Parameters Measured parameters The following is the used: General information male female Reference for adult's arterial blood range Reference: [10] Tietz NW, Logan NM. Reference ranges. In: Tietz NW, ed. Fundamentals of clinical chemistry. 3 ed.
  • Page 143 6. Parameters ABL800 FLEX Reference Manual Measured parameters, Continued Measuring range mmHg; torr: 5.0-250 (continued) kPa: 0.67-33.3 Reference range mmHg: 35– 48 (m); 32-45 (f) kPa: 4.67-6.40 (m); 4.27-6.00 (f) × × p (torr) Conversion of units 133322 (mmHg) p (kPa) = = 0133322 ×...
  • Page 144 ABL800 FLEX Reference Manual 6. Parameters Measured parameters, Continued Definition Concentration of total hemoglobin in blood. ctHb Total hemoglobin includes all types of hemoglobin: deoxy-, oxy-, carboxy-, met-. Unit g/dL; g/L; mmol/L Measuring range g/dL: 0.00- 27.7 g/L: 0.0-277 mmol/L: 0.00-17.2 Reference range g/dL: 13.5-17.5 (m);...
  • Page 145 6. Parameters ABL800 FLEX Reference Manual Measured parameters, Continued (continued) Reference: Siggaard-Andersen O, Wimberley PD, Fogh-Andersen N, Gøthgen IH. Arterial oxygen status determined with routine pH/blood gas equipment and multi-wavelength hemoximetry: reference values, precision and accuracy. Scand J Clin Lab Invest 1990; 50, Suppl 203: 57-66.
  • Page 146 ABL800 FLEX Reference Manual 6. Parameters Measured parameters, Continued Definition Fraction of carboxyhemoglobin in total hemo-globin in FCOHb blood. Unit %; fraction Measuring range %: 0.0-100.0 Fraction: 0.000-1.000 Reference range %: 0.5-1.5 (m, f) Fraction: 0.005-0.015 (m, f) Default value 0.004 (0.4 %)
  • Page 147 6. Parameters ABL800 FLEX Reference Manual Measured parameters, Continued FHHb × (1−FCOHb−FMetHb)−FCOHb− Equation FHHb = 1- sO (continued) −FMetHb If sO is not measured, it will be calculated from equation 39. If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default values.
  • Page 148 In: Siggaard-Andersen O, ed. Proceedings of the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980, Copenhagen: Radiometer Medical A/S, 1981: 163-90. Available as AS79. Definition Concentration of chloride ions in plasma.
  • Page 149 6. Parameters ABL800 FLEX Reference Manual Measured parameters, Continued Definition Concentration of lactate in plasma. cLac Unit mmol/L; meq/L; mg/dL Measuring range mmol/L: 0.0-30 meq/L: 0.0-30 mg/dL: 0-270 Reference range m, f: 0.5 - 1.6 mmol/L; 4.5 - 14.4 mg/dL Conversion of units cLactate (mg/dL) = 9.008 ×...
  • Page 150 ABL800 FLEX Reference Manual 6. Parameters Measured parameters, Continued ctBil (continued) The reference ranges are as follows: ctBil ≤24 hrs, premature 103 – 205 µmol/L 1.0 – 8.0 mg/dL 10 – 80 mg/L ≤24 hrs, full-term 34 – 103 µmol/L 2.0 –...

  • Page 151: Input Parameters

    6. Parameters ABL800 FLEX Reference Manual Input parameters Input parameters are the parameters keyed in by the operator on the Patient Definition Identification screen or transferred from an interfaced database. All input parameters are given in this section. Definition Patient temperature...
  • Page 152 ABL800 FLEX Reference Manual 6. Parameters Input parameters, Continued (v – ) Definition Oxygen tension of mixed venous blood. Input range/Unit mmHg; torr: 0.0-750.0 kPa: 0.00-100 Conversion p(kPa) =0.133322 × p(mmHg) × p(mmHg) = 500638 (kPa) (v – ) Definition Oxygen saturation of mixed venous blood.
  • Page 153 6. Parameters ABL800 FLEX Reference Manual Input parameters, Continued Can also be a derived parameter. p50(st) Definition Partial pressure (or tension) of oxygen at half saturation (50 %) in blood at standard conditions: temperature = 37 pH = 7.40 = 5.33 kPa...

  • Page 154: Derived Parameters

    ABL800 FLEX Reference Manual 6. Parameters Derived parameters In the Type column the following symbols are used: General information • ms for measured parameters • dv for derived parameters Acid-Base Symbol Definition Type derived pH(T) pH of blood at patient temperature.
  • Page 155 6. Parameters ABL800 FLEX Reference Manual Derived parameters, Continued Acid-Base Symbol Definition Type derived Concentration of total carbon dioxide in whole parameters ctCO blood (also termed CO content). (continued) Calculated based on the total CO concentrations in the two phases: plasma and erythrocyte fluid [5].
  • Page 156 ABL800 FLEX Reference Manual 6. Parameters Derived parameters, Continued Oxygen derived Symbol Definition Type parameters Partial pressure (or tension) of oxygen at patient temperature. Partial pressure (or tension) of oxygen in alveolar air. (A,T) Partial pressure (or tension) of oxygen in alveolar air at patient temperature.
  • Page 157 6. Parameters ABL800 FLEX Reference Manual Derived parameters, Continued Oxygen derived Symbol Definition Type parameters (a/A) Ratio of the partial pressure (or tension) of (continued) oxygen in arterial blood and alveolar air. Indicates the efficacy of the oxygenation process in the lungs.
  • Page 158 ABL800 FLEX Reference Manual 6. Parameters Derived parameters, Continued Oxygen derived Symbol Definition Type parameters Relative physiological shunt or concentration- (continued) FShunt based shunt [5,8,9]. • Calculated from the pulmonary shunt equation: & − & tO (a v) − tO A...

  • Page 159: Units And Numerical Format Of Derived Parameters

    6. Parameters ABL800 FLEX Reference Manual Units and numerical format of derived parameters Derived parameters are calculated or estimated on the basis of measured and keyed Calculated in data. Calculations are made using equations programmed into the analyzer. The versus estimated...
  • Page 160 ABL800 FLEX Reference Manual 6. Parameters Units and numerical format of derived parameters, Continued (ABL83X FLEX corresponds to ABL82X FLEX, but it can measure ctBil and Acid-base parameters FHbF). (continued) Symbol Unit Numerical ABL820/ Input Sample 810/15/ 25/30/35 format of...
  • Page 161 6. Parameters ABL800 FLEX Reference Manual Units and numerical format of derived parameters, Continued The table below lists the oxygen derived parameters. Oxygen parameters (ABL83X corresponds to an ABL82X, but it can measure ctBil and FHbF). Symbol Unit Numerical Input...
  • Page 162 ABL800 FLEX Reference Manual 6. Parameters Units and numerical format of derived parameters, Continued (ABL83X FLEX corresponds to ABL82X FLEX, but it can measure ctBil and Oxygen parameters FHbF). (continued) Symbol Unit Numerical Input Sample 810/15 820/25/ format of parameter...
  • Page 163 ODC is greater than 0.97, the calculation of the parameter is not performed unless the p50(st) value is keyed in. If not measured, e.g. ctHb (or derived by analyzer, e.g. p50(st)). The table below lists the electrolyte derived parameters for the ABL800 FLEX Electrolyte analyzers.

  • Page 164: List Of Equations

    ABL800 FLEX Reference Manual 6. Parameters List of equations All definitions and equations are based on SI units. If 'T' for patient temperature is Units and not stated, the calculation is based on a temperature of 37.0 °C. symbols The following SI units are used: concentration in mmol/L temperature in °C...
  • Page 165 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued where cBase(B) (continued) Description − × × a'= 4.04 10 4 25 10 ⎡ − ⎤ pH(st) 6.161 ⎢ ⎥ 0.9524 × × ⎣ ⎦ ( . ) 5 33...
  • Page 166 ABL800 FLEX Reference Manual 6. Parameters List of equations, Continued Eq. 11 [5]: ctCO − − × × × × ⎛ ⎞ × − ⎜ ⎟ ⎝ ⎠ where Description × × − 7 19 0 77 pH - 7.40 0 035 −...
  • Page 167 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued Description See… (continued) − − α 14.4 − − × × × × 37.0 37.0 P is the variable during iteration. 14.5 ∂ 14.6 × × 1.04 37.0 ∂ T = patient temperature in C (keyed-in).
  • Page 168 ABL800 FLEX Reference Manual 6. Parameters List of equations, Continued Eq. 17 : (a)/FO The calculation cannot be performed on the basis of the default FO (I) value, and the calculation requires entering the sample as “Arterial” or “Capillary”. Eq. 18 :...
  • Page 169 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued p50(T) Description See… (continued) P = ODC(S,A,T) Eq. 47 × − Eq. 46.11 COHb - MetHb COHb 1- MetHb ∂ − × × − ∂ ∂ = − × −...
  • Page 170 ABL800 FLEX Reference Manual 6. Parameters List of equations, Continued Eq. 24 : (a/A) (a/A) The calculation requires entering the sample type as “Arterial” or “Capillary”. Eq. 25 : (a/A,T) (a/A, The calculation requires entering the sample type as “Arterial” or “Capillary”.
  • Page 171 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued Eq. 27 [5]: α × × − − × COHb MetHb αO is the concentrational solubility coefficient for O in blood (here set to −3 –1 –1 9.83 mmolL at 37 C [5,19].
  • Page 172 ABL800 FLEX Reference Manual 6. Parameters List of equations, Continued (a) is determined as described in equation 27. c tO (or c (x) cannot be calculated on the basis of a default ctHb value. (continued) (a) ≤ 0.97 (or if p50(st) is keyed (x) can only be calculated if the measured sO in).
  • Page 173 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued F Shunt Description (continued) − 34.2 ⎡ ⎤ − tO a tO v Shunt = ⎢ ⎥ − tO A tO a ⎣ ⎦ where (c): total oxygen in pulmonary capillary blood (a): total oxygen in arterial blood (A): total oxygen in alveolar blood.
  • Page 174 ABL800 FLEX Reference Manual 6. Parameters List of equations, Continued Eq. 35 [5,16]: F Shunt( T ) − ⎡ ⎤ tO (a, ) - tO (v, ) Shunt( ) = ⎢ ⎥ tO (A, ) - tO (a, ) ⎣...
  • Page 175 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued Eq. 36 : − RI = The calculation requires entering the sample type as “Arterial” or “Capillary”. Eq. 37 : RI( T ) − O (A O (a RI( ) = O (a The calculation requires entering the sample type as “Arterial”...
  • Page 176 ABL800 FLEX Reference Manual 6. Parameters List of equations, Continued Eq. 39 : The ODC is determined as described in equation 46 (points I and III). See the section Oxyhemoglobin Dissociation Curve. × − − MetHb COHb 1 - COHb - MetHb...
  • Page 177 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued V (B) Description (continued) (CO) 42.1 V B ( ) = × × − × 2.184 10 COHb(2) COHb(1) V(CO) = volume (in mL) of carbon monoxide injected according to the 42.2...
  • Page 178 ABL800 FLEX Reference Manual 6. Parameters List of equations, Continued F HbF Step Description See… (continued) (for fetal blood) = ODC (pO , A,T); Eq.47 where FHbF = 1 (fetal blood) × ceHb × FHbF = sO − O HbF O HbF ∆F...
  • Page 179 6. Parameters ABL800 FLEX Reference Manual List of equations, Continued (x, T ) Description (continued) 50.8 i 2, (37 °C) − 2.3 mmol/L when t (T) = ctO (x,T) is calculated in accordance with OSA V3.0. (a) ≤ 0.97 (or p50(st) keyed in).

  • Page 180: Oxyhemoglobin Dissociation Curve (Odc)

    ABL800 FLEX Reference Manual 6. Parameters Oxyhemoglobin dissociation curve (ODC) These equations account for the effect of FCOHb on the shape of the ODC equations Oxyhemoglobin Dissociation Curve (ODC) in accordance with the Haldane equation. Eq. 46 [16,18]: − −...
  • Page 181 6. Parameters ABL800 FLEX Reference Manual Oxyhemoglobin dissociation curve (ODC), Continued The ODC displacement which is described by 'a' and 'b' in the coordinate system The ODC (ln(s/(1–s))vsln(p)), is given by the change in p50 from the default to its actual value...
  • Page 182 ABL800 FLEX Reference Manual 6. Parameters Oxyhemoglobin dissociation curve (ODC), Continued The actual position of the ODC at 37 °C for a given sample is, in principle, The actual ODC determined in two steps: position 1. The calculation of the combined effect on the ODC position at 37 °C of all known causes for displacement (= ac in equation 46.13), and based on this...
  • Page 183 6. Parameters ABL800 FLEX Reference Manual Oxyhemoglobin dissociation curve (ODC), Continued Determining the Step Description actual > 0.97 (or erroneous) and p50(st) is keyed in. displacement (II): (continued) Coordinates (P ) are calculated from (p50(st), 0.5) using equations 46.9 and 46.11.
  • Page 184 ABL800 FLEX Reference Manual 6. Parameters Oxyhemoglobin dissociation curve (ODC), Continued Calculation of a set of coordinates on the ODC is symbolized by: Coordinates on the ODC Eq. 47: S = ODC(P, A, T) or P = ODC(S, A, T) These equations are symbolic representations of the relationship between saturation (S), tension (P), displacement (A), and temperature (T).

  • Page 185: Conversion Of Units

    6. Parameters ABL800 FLEX Reference Manual Conversion of units The equations stated above are based on the SI-unit-system. If parameters are known SI units in other units, they must be converted into a SI-unit before entering the equations. The result will be in a SI-unit.

  • Page 186: Conversion Of Units

    ABL800 FLEX Reference Manual 6. Parameters Conversion of units, Continued · · · (mmol/L)/min = V /22.41 (mL/dL)/min [22] c Glucose = 18.016 × cGlucose (mmol/L) or cGlucose (mg/dL) = 0.055506 × cGlucose (mg/dL) cGlucose (mmol/L) [22] c Lactate = 9.008 × cLactate (mmol/L) or cLactate (mg/dL) = 0.11101 ×...

  • Page 187: Default Values

    6. Parameters ABL800 FLEX Reference Manual Default values The following default values are used in the ABL800 FLEX analyzers, if other Values values are not keyed-in. = 37.0 °C (99 °F) 0.21 (21.0 %) 0.86 9.3087 mmol/L, (15.00 g/dL or 150 g/L) ctHb 0.004 (0.4 %)

  • Page 188: Altitude Correction

    ABL800 FLEX Reference Manual 6. Parameters Altitude correction The barometric pressure is measured by the analyzer's built-in barometer, and the Equation for effect of barometric pressure on blood samples is compensated by the analyzer’s altitude software. correction Quality control result for pO...

  • Page 189: References

    In: Siggaard-Andersen O, ed. Proceedings of the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980. Copenhagen: Radiometer Medical A/S, 1981: 163-90. Available as AS79. 13. Severinghaus JW. Blood gas calculator. J Appl Physiol 1966; 21,3: 1108-16.
  • Page 190 22. Olesen H. et al. A proposal for an IUPAC/IFCC recommendation, quantities and units in clinical laboratory sciences. IUPAC/IFCC Stage 1, Draft 1, 1990: 1-361. 23. Kokholm G, Larsen E, Jensen ST, ChristiansenTF. 3 ed. Blood gas measurements at high altitudes. Copenhagen: Radiometer Medical A/S, 1991. Available as AS109. 6-53...
  • Page 191 Overview Introduction This chapter gives information about all the solutions and gases used with the ABL800 FLEX analyzer, their composition, use, and consumption. The Certificates of Traceability for the calibrating solutions are found at the end of the chapter. Contents This chapter contains the following topics.

  • Page 192: General Information

    Do not use a product after its expiration date. Safety Data Safety Data Sheets for all solutions are available from your Radiometer distributor. Sheets Information for re-ordering solutions from Radiometer can be found in the Re-ordering ABL800 FLEX Operator’s Manual, Chapter 14.

  • Page 193: Calibration Solutions

    ABL800 FLEX Reference Manual 7. Solutions and gas mixtures Calibration solutions Use: For calibration of the pH, electrolyte and metabolite S1820 and S1830 electrodes. Quantity: 200 mL Composition: Contains the following substances with the stated nominal concentrations: Solution Substance Concentration (mmol/L) S1820 1.25...

  • Page 194: Rinse And Cleaning Solutions

    Rinse and Cleaning solutions S4980 Rinse Use: For rinsing the liquid transport system after each measurement Solution or calibration. Quantity: 600 mL Composition: Contains salts, buffer, anticoagulant, preservative, and surfactants. Storage: At 2-32 C (36-90 Stability: Expiration date and Lot No. are printed on a separate label. When stored between 2-32 C (36-90 F), S4970 is stable for 25...

  • Page 195: Electrolyte Solutions

    ABL800 FLEX Reference Manual 7. Solutions and gas mixtures Electrolyte solutions List of solutions The following electrolyte solutions contained in the electrode jackets of the Radiometer electrodes are used: Electrolyte for… Quantity Composition E1001 reference 0.6 mL in 4 pre-filled...

  • Page 196: S5362 Hypochlorite Solution

    S5362 Hypochlorite solution S5362 Use: For protein removal and decontamination according to the Hypochlorite procedures described in the Operator's Manual, chapter 4: Solution Analyzer Menus and Programs. Quantity: 100 mL. Delivered with a 1 mL syringe. Contains sodium hypochlorite (pH ≈12). Composition: Storage: Keep in a dark place at 2-8...

  • Page 197: Gas Mixtures (Gas 1 And Gas 2)

    ABL800 FLEX Reference Manual 7. Solutions and gas mixtures Gas mixtures (Gas 1 and Gas 2) For calibration of the pCO and pO electrodes. Cylinder types The following types of Gas 1 cylinders are used depending on the geographical location of the analyser:...

  • Page 198: Traceability Certificates

    Traceability certificates...
  • Page 199 ABL800 FLEX Reference Manual 7. Solutions and gas mixtures...
  • Page 201 ABL800 FLEX Reference Manual 7. Solutions and gas mixtures 7-11...

  • Page 203: Index

    Index Absorbance ........................3-4 Additional information about FLEXMODE ..............5-46 Altitude Correction ......................6-51 Amperometric method ....................... 2-2 Bias ............................ 5-2 BiasABL chart description....................5-5 Calibration ........................1-3, 2-3 Calibration line ........................1-4 Calibration material ......................2-3 Calibration materials......................1-7 Continuous spectrum ......................3-5 Contribution to imprecision specifications from HbF correction ........
  • Page 204 Index ABL800 FLEX Reference Manual Oximetry parameters ....................5-50 pH/blood gas........................ 5-47 Lambert-Beer’s law ......................3-4 List of Equations......................6-27 Matrix of constants ......................3-6 Mean Corpuscular Hemoglobin Concentration MCHC ......................... 5-52 Measured parameters ......................3-2 Measured Parameters ......................6-5 Measuring time ........................
  • Page 205 ABL800 FLEX Reference Manual Index Status ........................... 1-10 pH electrode........................1-9 electrode Corrections - blood samples ..................2-8 Corrections - expired air samples ................2-10 Drift ..........................2-6 Sensitivity........................2-5 Stability criteria ......................2-10 Zero point ........................2-6 electrode........................2-4 Potentiometric method.......................

  • Page 206: Date Of Issue

    Date of Issue Manufacturer: Radiometer Representative: ABL800 FLEX Reference Manual from software identification version 4.12 Publication: December 2004 Edition: 200412B Code Number: 989-963 Specifications are based on 33694-A4.

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