Poct Abl800 Man

Contents
ABL800 FLEX
1. Potentiometric measuring principles
2. Amperometric measuring principles
3. Optical measuring principles
4. User-defined corrections
Reference
5. Performance specifications
manual
6. Parameters
7. Solutions and gas mixtures
Index
Date of Issue
System performance
The procedures described in this manual must be observed in order to ensure proper system
performance, and to avoid hazards.
Radiometer cannot provide or verify system performance characteristics if the system is not installed,
used and maintained in accordance with Radiometer procedures or if accessories not meeting the
specifications provided by Radiometer are used.
Radiometer warrants that the data media on which the software included in the system is furnished is
free from defects in material and workmanship under normal use for three (3) months from the date of
delivery as evidenced by a copy of invoice or receipt.
Third-party software and trademarks

The ABL800 FLEX analyzers comprise the Microsoft WindowsXP Embedded, VxWorks, Sybase,
SQL Anywhere, and Radiometer-developed software.
By using the system, you accept the terms of the Software License Agreement(s) of the provider(s) of
the above software as shown in the End User License Agreement(s) in the analyzer start up picture and
to the terms of the Microsoft WindowsXP Embedded End-User Agreement included in this manual. If
you cannot accept the terms of the Software License Agreement(s), you should not use the system, but
immediately contact your provider for a return of the system and a refund of the purchase price.
Microsoft and Windows are trademarks of Microsoft Corporation.
VxWorks is a registered trademark of WindRiver Systems Incorporated.
Sybase SQL Anywhere is a registered trademark of Sybase Incorporated.
Warranties and disclaimer

Radiometer makes no warranties, express or implied, other than expressly stated.
Any warranties expressly stated in this document are conditional upon the system being installed, used
and maintained in accordance with Radiometer procedures, including that only accessories meeting the
specifications provided by Radiometer are used.
Radiometer disclaims any liability for system performance if the system is not installed, used and
maintained in accordance with Radiometer procedures or if accessories not meeting the specifications
provided by Radiometer are used.
Further, Radiometer disclaims any liability for loss of data and direct, consequential or other damages,
including loss of profit or loss of business, whether such claim for damages is based upon contract,
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Confidentiality
The contents of this document shall not be reproduced or communicated to any third party without the
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Changes
This document is subject to change without notice and you are urged to contact Radiometer to verify
whether the document has been changed.
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changed from time to time, Radiometer disclaims any liability for errors and omissions.
Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of
Radiometer Medical ApS.
2008 Radiometer Medical ApS. All rights reserved.
Contents
Contents ................................................................................................................1
TU UT
1. Potentiometric measuring principles ............................................................. 1-1

Overview........................................................................................................... 1-1
General information .......................................................................................... 1-2
Reference electrode........................................................................................... 1-8
pH electrode ...................................................................................................... 1-9
pCO2 electrode ................................................................................................ 1-15
B B
Electrolyte electrodes...................................................................................... 1-23

References....................................................................................................... 1-37
2. Amperometric measuring principles ............................................................. 2-1
Overview........................................................................................................... 2-1
pO2 electrode..................................................................................................... 2-4
B B
Glucose and Lactate electrodes....................................................................... 2-13

Crea electrodes................................................................................................ 2-23
References....................................................................................................... 2-31
3. Optical measuring principles.......................................................................... 3-1
Overview........................................................................................................... 3-1
Optical system................................................................................................... 3-2
Correcting for interferences .............................................................................. 3-7
Measurement and corrections ........................................................................... 3-9
References....................................................................................................... 3-15
4. User-defined corrections ................................................................................. 4-1
Overview........................................................................................................... 4-1
Correction factors for oximetry parameters and bilirubin................................. 4-4
Electrolyte and metabolite parameters .............................................................. 4-7
5. Performance characteristics ........................................................................... 5-1
Overview........................................................................................................... 5-1
Definition of terms............................................................................................ 5-2
ABL8x0/8x5 Performance characteristics .................................................... 5-5
Overview........................................................................................................... 5-5
Test conditions .................................................................................................. 5-6
Performance test results chart description...................................................... 5-7
Performance test results pH ......................................................................... 5-10
Contents ABL800 FLEX Reference Manual
Performance test results pCO2 ..................................................................... 5-12

B B
Performance test results pO2 ........................................................................ 5-15

B B
+
Performance test results cK ........................................................................ 5-18
P P
Performance test results cNa+ ...................................................................... 5-20

P P
Performance test results cCl ....................................................................... 5-22

P P
2+
Performance test results cCa ..................................................................... 5-24
P P
Performance test results cGlu ...................................................................... 5-26

Performance test results cLac ...................................................................... 5-28
Performance test results ctHb ...................................................................... 5-30
Performance test results oximetry................................................................ 5-32
Performance test results bilirubin ................................................................ 5-42
Additional information about FLEXMODE ................................................... 5-48
ABL8x7 Performance characteristics ......................................................... 5-49
Overview......................................................................................................... 5-49
Test conditions ................................................................................................ 5-50
Performance test results pH, pCO2, pO2 ...................................................... 5-51
B B B B
Performance test results electrolytes............................................................ 5-54

Performance test results cGlu, cLac............................................................. 5-58
Performance test results ctHb ...................................................................... 5-60
Performance test results oximetry................................................................ 5-61
Performance test results bilirubin ................................................................ 5-70
Performance test conditions and results cCrea............................................. 5-72
Interference tests ............................................................................................. 5-92
References..................................................................................................... 5-103
6. Parameters ....................................................................................................... 6-1
Overview........................................................................................................... 6-1
Measured parameters ........................................................................................ 6-5
Input parameters.............................................................................................. 6-14
Derived parameters ......................................................................................... 6-17
Units of derived parameters ............................................................................ 6-22
List of equations.............................................................................................. 6-28
Oxyhemoglobin dissociation curve (ODC)..................................................... 6-44
Conversion of units ......................................................................................... 6-49
Default values ................................................................................................. 6-51
Altitude correction .......................................................................................... 6-52
References....................................................................................................... 6-53
ABL800 FLEX Reference Manual Contents
7. Solutions and gas mixtures ............................................................................. 7-1

Overview........................................................................................................... 7-1
Calibration solutions ......................................................................................... 7-3
Rinse and Cleaning solutions............................................................................ 7-6
Electrolyte solutions ......................................................................................... 7-8
S5362 Hypochlorite Solution.......................................................................... 7-10
Gas mixtures (Gas 1 and Gas 2)...................................................................... 7-11
Traceability certificates................................................................................... 7-12
Index
T
Date of Issue
T
Contents ABL800 FLEX Reference Manual
Warnings/Cautions
T
Definitions Throughout the manual, the descriptions may contain operational precautions and
warnings.
Notice Definition
WARNING
T T
Warning alerts users to potential serious outcomes to
themselves or the patient (such as death, injury, or serious
adverse events).
PRECAUTION
T T Precaution alerts users to exercise special care necessary for
the safe and effective use of the device. Precaution may
include actions to be taken to avoid effects on patients or
users that may not be potentially life threatening or result in
serious injury, but about which the user should be aware.
Precaution may also alert users to adverse effects on the
device by use or misuse, and the care necessary to avoid such
effects.
NOTE
T T Notes give practical information.
WARNING/
T
In this manual a distinction between a warning and a caution is not made. Any
CAUTION T
notice that alerts the user to possible dangers of any kind is given the title
WARNING/CAUTION.
T T
1. Potentiometric measuring principles
Overview
Introduction This chapter describes the potentiometric measuring principles and the pH, pCO2 B B
and electrolyte electrodes that are based on this principle.
Contents This chapter contains the following topics.

General information ......................................................................................... 1-2
X X
Reference electrode.......................................................................................... 1-8

X X
pH electrode ..................................................................................................... 1-9

X X
pCO2 electrode ................................................................................................. 1-15

B B X X
Electrolyte electrodes ....................................................................................... 1-23 X X
References ........................................................................................................ 1-37

X X
1. Potentiometric measuring principles ABL800 FLEX reference manual
General information
Potentiometric The potential of an electrode chain is recorded using a voltmeter, and related to the
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.
Voltmeter
Reference Electrolyte Electrolyte

electrode solution Sample solution Electrode
Membrane Membrane
Every element in the electrode chain contributes a voltage to the total potential
drop through the chain. Thus:
When immersed in the appropriate electrolyte solution, both electrodes have
separate potentials
The membrane junctions between the sample and electrolyte solutions also have
separate potentials
The potentiometric measuring principle is applied to pH, pCO2 and electrolyte T T B B
electrodes.
Nernst equation The complete electrode chain potential therefore is the sum of these separate
potentials and is the quantity measured by the voltmeter.
Etotal = Esample ERef
T B B B B B
where the final unknown potential (Esample) can be calculated knowing the total
T B TB
electrode chain potential (Etotal) and the reference potential (ERef is constant
T B TB T B TB
between two subsequent calibrations).

Having measured the unknown potential (Esample), the Nernst equation is then T B TB
applied to determine the activity (ax) of the species under study:

T TB B
2.3RT
E sample = E 0 + log a x
nF
where:
E0 = standard electrode potential
R = gas constant (8.3143 Joule K1 mol1) P P P P
T
T T = absolute temperature (310 K (37 oC )) P P
Continued on next page
1-2
ABL800 FLEX reference manual 1. Potentiometric measuring principles
General information, Continued T T
Nernst equation
(continued)
T
n
T T = charge on the ion
F = Faraday constant (96487 coulomb mol1) P P
ax = activity of x T T
The Nernst equation is rearranged to express the activity as a function of the

potential Esample. Having measured Esample the activity can be calculated since all
T B TB T B B T
other quantities are already known. Finally the analyzer converts activity to
concentration.
Strictly speaking, the potential of an electrode chain or the magnitude of current
flowing through an electrical chain is related to the activity of a substance, and not
its concentration.
Activity expresses the "effective concentration" of a species, taking non-ideality of
the medium into account.
Activity and concentration are related by the following equation:
ax = cx
T TB B T TB B
where:
ax = the activity of the species x
T TB B
= the activity coefficient of species x under the measurement conditions

(for ideal systems = 1)
cx
T TB B = the concentration of species (mmol/L)
NOTE: To be exact, activity is related to the molality of species x, i.e., the number
T T
of mmoles per kg of solvent. However, molality is converted to concentration

(molarity). T
The analyzer automatically converts activities into concentrations [1]. The term
concentration is therefore used in explanations of the measuring principles for each
of the electrodes further on in this chapter.
The potentiometric measuring principle is applied in the pH, pCO2 and electrolyte B B
electrodes. It is slightly different for the pCO2 electrode, however, since the Nernst T T B B
equation is not directly applied.
Calibration Calibration is an analytical process defining the functional relationship between the
obtained readings or analytical responses and the concentration or other quantities
present in the calibration material (liquid or gas). Thus, a calibrating solution or a
gas mixture (for pCO2 calibrations) is drawn into the measuring chamber and the
B B
analyzer adjusts itself to measure the known value of the liquid or gas.
1-3
Calibration The electrodes are active elements and must be calibrated regularly. Signals from
(continued) the electrodes change because of, e.g., protein build-up, worn-out membranes,
aging electrodes, etc.
T T
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. The relationship between the electrode
amplifiers output and the pH/pCO2 /electrolyte electrodes are simple mathematical
B B
functions. Calibration data can therefore be determined by relating the electrode

signals during the calibration process to the values of the calibrating solutions.
Calibration line The calibration line expresses the relationship between the potential measured at
an electrode, and the concentration of the species specific to the electrode. The
calibration line forms the basis of the scale used by the analyzer to convert
electrode chain potentials to concentrations. Each electrode has a different
calibration line.
The pH electrode is used as an example to illustrate how the calibration line is
derived from two calibration solutions with known pH.
The calibration solutions give the following two points: 64 mV at pH 6.802 (Cal T T
2) and 100 mV at pH 7.398 (Cal 1)

T T
Within the coverage range 6.300 to 8.000 the pH electrode is linear, and the
relationship between potential and pH is linear, so a line can be drawn between the
two points, as shown below:
Measured
potential This is a 2-point calibration.
(mV) 64 In 1-point calibration, only
the position of the calibration
Calibration line line is determined. The slope
97 of the calibration line is
100
maintained from the last 2-
point calibration.
pH
6.802 7.346 7.398
pH of Cal 2 sol. pH of sample pH of Cal 1 sol.
The calibration line is stored in the computer and is used during measurement to
convert the potential measured at the pH electrode during sample analysis to an
actual pH value.
1-4
Calibration line To describe the actual condition of the electrode, its calibration line is compared to
(continued)
T T the calibration line of the theoretical electrode.
Measured
potential The theoretical electrode is
(mV) 75.5
defined to measure the
following:
Theoretical calibration line
112.4 mV at pH 7.400,
112.4 75.5 mV at pH 6.800.
pH
6.8 7.4
The position and slope of the calibration line compared to the theoretical
calibration line are described by the status and sensitivity.
Sensitivity The electrode sensitivity illustrates the slope of the calibration line compared to the
slope of the theoretical electrode.
The sensitivity of the theoretical electrode is 100 % or 1.00.
Measured
potential
If an electrode
has a sensitivity
2-point calibration line
(mV) 75.5
Slope = 58.4 mV/pH
Sensitivity = 95 % of 95 % or 0.95,
its sensitivity is
Theoretical calibration line 5 % lower than
Slope= 61.5 mV/pH
112.4
Sensitivity = 100 % the theoretical
electrode.
pH
6.8 7.4
The sensitivity of an electrode is calculated as:

Potential at 6.802 Potential at 7.398
Sensitivity = (%)
61.5 (7.398 6.802)
where 61.5 = sensitivity of theoretical electrode.
Each electrode has its own sensitivity limits.
1-5
Status Status reflects the deviation from the theoretical electrode at pH 7.400 and,
therefore, indicates the position of the calibration line.
Measured Theoretical calibration line for the A calibration

potential theoretical pH electrode with known
potential of 112.4 mV at a pH =
line with the
(mV)
7.400. same slope as
pH Theoretical calibration
the theoretical
ECal 1 nom(theo)
E=112.4 mV
line drawn through the 1- calibration line
E point calibration point.
ECal 1 nom (61.5 mV/
ECal 1 pH) is drawn
through this
pH point.
pHStatus pHCal 1 nom pHCal 1
(7.400)
The calibration line for the actual electrode deviates from that of the theoretical
electrode. The status value describes this deviation.
Status of the actual pH electrode at pH 7.400 is calculated as:
Meas. potential at 7.400 Potential of theoretical electr. at 7.400
Status = 7.400
61.5 100
Each electrode has its own status limits.
Drift Drift of an electrode is a measure of stability obtained by comparing the last

accepted calibration with the previous calibration.
The following drift values are used:
Drift 1 obtained on Cal 1 and/or Gas 1
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. If the drift tolerances are made
wider, no warning will be given if the electrodes should become unstable.
Significant measurement errors could result.
1-6
Calibration The following calibration materials are used:

materials
Calibration material
T T T Used for... T
Calibration Solutions 1 and 2: the exact composition of Calibration of the pH,

the calibration solutions is given in the barcode on the and electrolyte
bottle label, which can be read into the analyzer using the electrodes
barcode reader, or entered manually via the keyboard.
Gas 1 and Gas 2: each gas has a precise composition Calibration of the
essential for determining the accuracy of the analyzer in pCO2 electrode
B B
each pCO2 measurement; the exact composition of the

B B
calibration solutions is given in the barcode on the bottle

label, which can be read into the analyzer using the
barcode reader, or entered manually via the keyboard.
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.
T T
Measuring time The measuring time of the electrode is independent of the electrode type. Electrode
signals are registered at 0.982-second intervals during both calibrations and
measurements. The registration of each electrode signal begins after the samples,
calibration solutions and calibration gases are in position in the measuring
modules. The duration of each calibration is predetermined, as is the number of
updatings of the electrodes signals.
Updatings In general, the updatings from an electrode response are numbered from 1 to upd. T
last, where updating number 1 is the first updating and upd.last is the last. The
T T T
diagram below schematically illustrates the electrode response that is calculated on

uncorrected electrode updating values.
Signal
Updatings
Upd. 1 Upd. last
1-7
Reference electrode
Description The reference electrode is used in the measurement of pH and electrolyte

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. The potential is not altered by sample
composition.
A fixed potential is maintained at the reference electrode by the following
equilibrium reactions:
AgCl Ag+ + Cl
T P P P TP
Ag+ + e Ag
T P P P P T
These reactions are possible because the electrode is made from a Ag rod coated
with AgCl to provide the Ag/Ag+ equilibrium and determine the reference
P P
potential.
Electrode contact The electrolyte solution acts as a salt-bridge

solution that maintains an electrical contact
between the coated Ag wire and the sample.
The solution is 4 M sodium formate
(HCOONa), adjusted to pH 5.5 with
hydrochloric acid.
Electrode jacket
The chloride concentration in the electrolyte
Electrolyte solution is adjusted in accordance with the
chloride concentration in the Rinse Solution,
Ag rod coated
to reduce Cl exchange across the
P P
with AgCl membrane, thereby obtaining a more stable

potential.
The electrode is encased in the electrode
jacket: The rubber ring seals the electrode in
3-layer membrane the jacket to prevent evaporation or leakage
of the electrolyte solution.
The membrane consists of three separate membranes:
Membrane Function
Inner To limit diffusion through the membrane and stabilize the whole
membrane system.
Middle To prevent protein interference.
Outer To reduce the interchange of sample or Rinse Solution and
HCOONa solution.
Packaging The E1001 reference electrode comes in a box with an insert explaining the
preparation of the electrode and its use.
1-8
pH electrode
Description The pH electrode (E777) is a pH-sensitive glass electrode. The pH-sensitive glass
membrane is located at the tip and seals the inner buffer solution with a constant
and known pH.
The air bubble allows for expansion
Electrode contact of the inner buffer solution when the
electrode is thermostatted to 37 oC.P P
Electrode The potential difference across the

glass membrane is due to a change
in the charge balance at the
membrane.
The glass membrane is sensitive to
H+ ions. The metal ions in the glass
P P
Inner buffer
are exchanged with protons on either
solution side of the membrane, from the inner
buffer solution on one side and the
sample on the other.
Glass membrane
A difference in the ion exchange on either side of the membrane occurs if the H+ P P
concentration (and therefore pH) is unequal on both sides. The number of positive
and negative ions is no longer equal, so the potential difference across the
membrane changes. If the H+ concentrations on either side of the membrane are
P P
equal, the potential difference will theoretically be 0 mV.
Nernst equation The theoretical sensitivity of the pH electrode at 37 oC being equal to 61.5 mV
P P
per pH unit, using pH = log [H+], and converting concentration to activity, the
P P
Nernst equation can be expressed as:

. pH
E sample = E 0 615 mV
Designation The following symbols are used:

61.5 mV/pH = Theoretical sensitivity of the pH electrode at 37 oC
P P
E(pH,Cal2) = Potential of the pH electrode chain from a calibration

measurement on Cal 2 solution
E(pH,Cal1) = Potential of the pH electrode chain from a calibration
measurement on Cal 1 solution
E0(pH,Cal1)
B B = Standard potential of the pH electrode chain with a nominal
pH = 7.4 (the approximate pH of Cal 1 solution)
1-9
pH electrode, Continued T T
Designation
pH(Cal1,nom) = Nominal pH of Cal 1 solution (pH = 7.4)
(continued)
T
pH(Cal1) = pH of Cal 1 solution

E(pH,Cal1prev) = Potential of the pH electrode chain from the previous
calibration measurement on Cal 1 solution
Sens(pH,prev) = Sensitivity of the pH electrode from the previous 2-point
fraction calibration
pH(Cal1,prev) = pH of Cal 1 solution in the previous calibration
measurement
pH(Cal2) = pH of Cal 2 solution
Sens(pH) = Relative sensitivity of the pH electrode chain.
Sensitivity The sensitivity of the pH electrode (SenspH) is obtained from the calibration line
B B
obtained from a 2-point calibration on Calibration Solutions 1 and 2 (Cal 1 and Cal
2), and is calculated from the following equation:
E(pH, Cal2) E(pH, Cal1)
Sens(pH) = (fraction)
61.5 [pH(Cal2) pH(Cal1)]
The sensitivity of the pH electrode should fall between 0.92-1.03 or 92-103 %.
Status The status of the pH electrode is calculated from the following equation:
E(pH, Cal1) E 0 (pH, Cal1)
Status(pH) = + 2 pH(Cal1, nom) pH(Cal1)
- 61.5
The status of the pH electrode should fall between a pH of 6.7 and 8.1.
Drift Drift 1 is calculated from the following equation:

E(pH, Cal1) E(pH, Cal1prev)
Drift 1(pH) = [pH(Cal1) pH(Cal1, prev)]
- 61.5 Sens(pH, prev)
NOTE: Under normal circumstances, pH(Cal1) pH(Cal1,prev) = 0. However, in

T T T T
instances where the Cal 1 solution container has been replaced between two
consecutive calibrations, pH(Cal1) pH(Cal1,prev) 0.
T T T
The default drift tolerances set by Radiometer for Drift 1 are 0.020.
Drift 2 is calculated from the following equation:

E(pH,Cal2) E(pH,Cal1prev)
Drift 2(pH) = [ pH(Cal2) pH(Cal1, prev)]
- 61.5 Sens(pH, prev)
The default drift tolerances set by Radiometer for Drift 2 are 0.020.
1-10
Measurement The sample pH is calculated as follows:

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
reference method using the following equation:
Equation A:
T T
pH(sample,corr.) = A0 pH(sample) + A1
B B B B
where:
pH(sample) = uncorrected pH value of the sample
pH(sample,corr.) = corrected pH value of the sample.
A0 B B = instrument-dependent correction factor
A1 B B = instrument-dependent cut-off
Equation A+:
T
When an additional correction is needed, equation A is first used together with the
constants for the macromode S250 and FLEXMODE (195 and 165 L, no
message) mode. Then the obtained results are put back into equation A as
pH(sample) and then treated again, using the constants for the specific sample
handling to obtain the corrected value.
Corrections are as follows:
ABL8xx
T Mode
T T T A0
B TB T A1
B TB Equation
T T
FLEX T
37/27/17 S250 1.000 0.009 A

C125 1.000 0.009 A
FLEXMODE (message 903) 1.000 0.009 A
1-11
pH electrode, ContinuedT T
Corrections
(continued)
T
ABL8xx Mode A0B B A1
B B Equation
FLEX
35/25/15 S195 0.9964 0.0150 A
S95 0.9964 0.0150 A
S85 0.9964 0.0150 A
C95 1.007 0.053 A+
C55 1.025 0.1880 A+
FLEXMODE (no message) 0,9964 0.0150 A
FLEXMODE (message 897) 1.007 0.0530 A+
30/20/10 S85 0,9964 0.0150 A
10 BG C55 1.025 0.1880 A+
only
FLEX FLEXMODE (no message) 1.0006 0.0035 A+
1-12
pH electrode, Continued
T T
Corrections
(continued)
T
ABL8xx Mode A0
B B A1B B Equation
FLEX
05 S165 0,9964 0.0150 A
S95 0,9964 0.0150 A
S85 0,9964 0.0150 A
C95 1.007 0.053 A+
C55 1.025 0.1880 A+
FLEXMODE (no message) 0,9964 0.0150 A
00 BASIC S195 0.9964 0.0150 A
S95 0.9964 0.0150 A
S85 0.9964 0.0150 A
C95 1.007 0.053 A+
C55 1.025 0.1880 A+
1-13
Stability criteria The following stability criterion must be met to obtain a stable electrode response
during 1- and 2-point calibrations:
T T
pH(sample, upd.last) pH(sample, upd.i) pH(limit)
The following stability criterion must be met to obtain a stable electrode response
during measurement:
T T
pH(sample, upd.last) pH(sample, upd.i) pH(limit)
where:
pH(sample,upd.last) = pH value from the last updating with a measurement

on calibration solution or sample. (The last updating
is number 30.)
pH(sample,upd.i) = pH value for a given updating with a measurement
on calibration solution or sample. (The relationship
must be fulfilled for at least one of the updating
numbers 20 or 21.)
pH(limit) = pH limiting value for the stability criterion (0.005).
1-14
pCO2 electrode
T T B B
Description The pCO2 electrode (E788) is a combined pH and Ag/AgCl reference electrode
B B
mounted in a plastic jacket, which is filled with a bicarbonate electrolyte.

Electrode contact The jacket is covered by a 20-
m silicone membrane
moulded on a 50-m nylon net.
The net both reinforces the
silicone membrane and serves
as a spacer in order to trap a
Electrode jacket layer of the electrolyte between
the membrane and the glass tip
of the electrode. The electrolyte
Electrolyte also contains glycerol to
prevent collection of air
Ag/AgCl reference band bubbles in the electrode jacket,
thus improving electrode
stability.
Membrane
The membrane allows any uncharged molecules of CO2, O2 and N2 to pass through B B B B B B
it. Charged ions such as H+ will not pass. Consequently, dissolved CO2 from the
P P B B
sample will diffuse into the thin layer of bicarbonate electrolyte until the
equilibrium is reached.
This produces carbonic acid:
H2O + CO2 H2CO3
B B B B B B B
Carbonic acid dissociates according to the following equilibrium reaction:

H 2 CO 3 H + + H 2 CO 3
The release of H+ ions changes the H+ concentration, and therefore the pH of the
P P P P
solution on one side of the pH-sensitive glass membrane.

The concentration gradient of H+ ions on the other side of the membrane affects
P P
the potential difference across the glass membrane. This change in potential across
the glass membrane is measured by the voltmeter.
Nernst equation The Nernst equation is used to convert the potential reading into a pH value:
E glass = E 0 61.5 pH (mV)
where:
Eglass
T TB B = potential difference across the glass membrane
E0
T TB B = standard electrode potential
61.5 mV/pH = theoretical sensitivity of the pH electrode at 37 oC P P
1-15
pCO2 electrode, Continued

T T B B T T
Nernst equation The pH value is related to the partial pressure of CO2 in the sample by the B B
(continued)
T following equation:
T
cHCO 3-
pH = pK a + log
pCO 2 CO 2
where:
pK a = log Ka, the equilibrium constant for the dissociation of carbonic acid in
B B
water
CO 2 = solubility coefficient for CO2 in water B B
The bicarbonate concentration HCO -3 is so large compared to H + that it can be [ ] [ ]

considered constant. At constant temperatures CO 2 is also constant. So the
equation can be simplified to:
pH = K'- log pCO 2
where:
K' is a constant incorporating the equilibrium constant for carbonic acid (Ka), the B B
bicarbonate concentration and the solubility coefficient CO 2 .
cH + cHCO 3
Ka = is the equilibrium constant for carbonic acid.
CO 2
pCO2 of the sample is then calculated from the equation above.
B B
Designation The following symbols are used:

pCO2(Gas1),
T T = Pressure of CO2 in Gas 1 or Gas 2, respectively
B B B B
pCO2(Gas2)
T T B B
FCO2(Gas1),
T T B B T =
T T Fraction of CO2 in Gas 1 or Gas 2, respectively
B B T
FCO2(Gas2)
T T B B T
BGas 1 or 2
T TB B
= Pressure inside the measuring chamber during a

measurement on Gas 1 or Gas 2, respectively
pH 2 O = Water vapor pressure (6.2751 kPa at 37 oC) P P
E(CO2,Gas1), B B
= Potential of the pCO2 electrode from a measurement on

E(CO2,Gas2)
B B
B B
Gas 1 or Gas 2, respectively

Sens(pCO2,theo) B B
= Theoretical (absolute) sensitivity of the pCO2 electrode B B
at 37 oCP P
Sens(pCO2,prev) B B
= Relative sensitivity of the pCO2 electrode from the B B
previous 2-point calibration
1-16

T T B B T T
Designation
E0(CO2,Gas1) = Standard potential of the pCO2 electrode with Gas 1
(continued)
B B B B
B B
E(CO2,Gas1,prev)
B B
= Potential of the pCO2 electrode from the previous

B B
measurement on Gas 1
= Difference between pCO2 (sample) from the first and
T T B B
last updatings
predict = Extrapolated value for pCO2 T T B B
Sensitivity The pCO2 electrode is calibrated on two gases with known CO2 contents:
B B B B
Gas 1: 5.61 % CO2 and Gas 2: 11.22 % CO2. B B B B
The exact composition of the calibration gases is contained in their barcodes.

The partial pressures of CO2 in Gas 1 and Gas 2 are calculated from the following B B
equations:
pCO 2 (Gas1) = FCO 2 (Gas1) ( BGas 1 pH 2 O) kPa
pCO 2 (Gas2) = FCO 2 (Gas2) ( BGas 2 pH 2 O) kPa
The relative sensitivity of the pCO2 electrode is calculated as follows: B B
E(CO 2 ,Gas2) E(CO 2 ,Gas1)

Sens( pCO 2 ) =
pCO 2 (Gas2)
Sens( pCO 2 , theo) log
pCO 2 (Gas1)
The sensitivity of the pCO2 electrode should fall between 0.85-1.00 B B
or 85-100 %.
Status The status of the pCO2 electrode is calculated as follows: B B
E(CO 2 ,Gas1) E 0 (CO 2 , Gas1)

Sens( pCO 2 , theo)
Status( pCO 2 ) = pCO 2 (Gas1) 10 kPa
The status of the pCO2 electrode should fall between 6.2-260 mmHg (0.83-34.66 kPa).
B B
Drift Drift 1 is calculated as follows:

E(CO 2 , Gas1) E(CO 2 , Gas1, prev)
Sens( pCO 2 , prev)Sens( pCO 2 , theo)
Drift 1( pCO 2 ) = pCO 2 (Gas1) 10 pCO 2 (Gas1, prev) kPa
Drift 2 is calculated as follows:

E(CO 2 ,Gas2) E(CO 2 , Gas1, prev)
Drift 2( pCO 2 ) = pCO 2 (Gas2) 10 pCO 2 (Gas2, prev) kPa
1-17

T T B B T T
Drift (continued) The default drift tolerances set by Radiometer are as follows:
T T
for Drift 1: 0.33 kPa (2.5 mmHg)

for Drift 2: 0.67 kPa (5.0 mmHg)
Measurement The pCO2 value for a sample is calculated from the following equations:
T T B B
E(CO 2sample,updi) E(CO 2 Gas1)

pCO 2 (sample, updi ) = pCO 2 (Gas1) 10
= pCO 2 (sample, upd30) pCO 2 (sample, upd1)
pCO 2 (sample, upd6) pCO 2 (sample, upd30) [ pCO 2 (sample, upd18)]

2
predict =
pCO 2 (sample, upd6) + pCO 2 (sample, upd30) 2 pCO 2 (sample, upd18)
For < 1.33 kPa, pCO2(sample) = pCO2(sample,upd30) T T B B T T B B
For 1.33 kPa < < 2.66 kPa

T T
predict ( 1.33) + pCO 2 (sample, upd30) (2.66 )

pCO 2 (sample) =
1.33
For 2.66 kPa, pCO2(sample) = predict.

T T T T B B
Corrections The pCO2 measured on a sample is then corrected for systematic deviations from
T T B B
blood samples the reference method using the following equations:

Equation A:
T
pCO2(sample,corr) = A3 pCO2(sample)3 + A2 pCO2(sample)2 +

T T B B B B T T B B P P B B T T B B P P
+ A0 pCO2(sample) + A1 (B pH2O) B B T T B B B B T T T T B B
where: pCO2(sample) B B = uncorrected value of pCO2 in the sample T T B B
pCO2(sample, corr) B B = corrected value of pCO2 in the sample T T B B
A0 B B = correction factor
pH2O
T T B B = partial pressure of saturated water vapor (6.2751
kPa)
and
1-18

T T B B T T
Corrections Equation B:
T T
blood samples pCO2(sample,corr) = B1 pCO2(sample) + B0

T T B B B B T T B B B B
(continued)
T T
where: B0 B B = correction cut-off

B1 B B = correction factor
ABL8xx
T T Mode T A0
T B TB T A1 B TB A2
T B TB A3
T B TB B0
T B TB T B1
B TB Eq.
T T
FLEX T
37/27/17 S250 1.1233 -0.003303 0.003 -0.00002 A

C125 1.1233 -0.003303 0.003 -0.00002 A
*FM (message 1.1233 -0.003303 0.003 -0.00002 1.05742 -0.158 A, B
903)
*FM (message 1.1233 -0.003303 0.003 -0.00002 1.05742 -0.158 A, B
902)
*FM (message 1.1233 -0.003303 0.003 -0.00002 1.05742 -0.158 A, B
901)
*FM (message 1.1233 -0.003303 0.003 -0.00002 1.05742 -0.158 A, B
900)
*FM (message 1.1233 -0.003303 0.003 -0.00002 1.05742 -0.158 A, B
899)
*FM (message 1.1233 -0.003303 0.003 -0.00002 1.05742 -0.158 A, B
898)
35/25/15 S195 1.1126 -0.003573 0.0051 -0.0000002 A
S95 1.1126 -0.003573 0.0051 -0.0000002 1.000 -0.016 A, B
S85 1.1126 -0.003573 0.0051 -0.0000002 A
C95 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
C55 1.1126 -0.003573 0.0051 -0.0000002 1.12 -0.28 A, B
*FM (no 1.1126 -0.003573 0.0051 -0.0000002 A
message)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
897)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
895)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
894)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
873)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.0884 -0.1619 A, B
872)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.090 -0.150 A, B
871)
1-19

T T B B T T
Corrections
blood samples
(continued)
T
ABL8xx
T T Mode T A0
T B TB A1
T B TB A2
T B TB A3
T B TB T B0
B TB B1
T B TB T Eq.
T
FLEXT
30/20/10 S85 1.1126 -0.003573 0.0051 -0.0000002 A

10 BG C 55 1.1126 -0.003573 0.0051 -0.0000002 1.12 -0.28 A, B
only
FLEX *FM (no 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.050 A, B
message)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.0819 -0.0495 A, B
872)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.090 -0.150 A, B
871)
05 S165 1.1126 -0.003573 0.0051 -0.0000002 A
S95 1.1126 -0.003573 0.0051 -0.0000002 1.000 -0.016 A, B
S85 1.1126 -0.003573 0.0051 -0.0000002 A
C95 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
C55 1.1126 -0.003573 0.0051 -0.0000002 1.12 -0.28 A, B
*FM (no 1.1126 -0.003573 0.0051 -0.0000002 A
message)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
897)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
895)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
894)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.013 0.010 A, B
873)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.0884 -0.1619 A, B
872)
*FM (message 1.1126 -0.003573 0.0051 -0.0000002 1.090 -0.150 A, B
871)
00 S195 -0.003573 1.1126 0.0051 -0.0000002 A
BASIC S95 -0.003573 1.1126 0.0051 -0.0000002 1.000 -0.016 A, B
S85 -0.003573 1.1126 0.0051 -0.0000002 A
C95 -0.003573 1.1126 0.0051 -0.0000002 1.013 0.010 A, B
C55 -0.003573 1.1126 0.0051 -0.0000002 1.12 -0.28 A, B
*FM = FLEXMODE.
1-20

T T B B T T
Corrections The pCO2 measured from the sample is then corrected for systematic deviations
B B
expired air from the reference method using the following equation:
samples pCO 2 (sample, corr) = A 0 pCO 2 (sample) + A 1 ( B pH 2 O) Equation A: T T
where:
pCO2(sample)
T T B B = uncorrected pCO2 value of an expired air sample
T T B B
pCO2(sample,corr) = corrected pCO2 value of an expired air sample

T T B B T T B B
A0 B B
= instrument-dependent correction factor
A1 B B
B
T T
= barometric pressure during the measurement
pH2O
T T B B
= partial pressure of saturated water vapour = 6.2751 kPa
ABL8xx
T T
Mode
T T T A0 B TB A1
T B TB T Equation T
All FLEX and Expired air 1.0196 0.00106 A

BASIC
during calibration:
pCO 2 (sample, upd.last) pCO 2 (sample, upd.i) pCO2 (limit) B B
This criterion is valid for calibrations using Gas 1 and Gas 2 where:
Parameter pCO2 value from the last updating number...

B B
ABL8x5/8x7 FLEX
T T ABL8x0 FLEX
T T
pCO2(sample,upd.last) B B 92 62
pCO2(sample,upd.i) B B 86 or 87 56 or 57
(the relationship must be fulfilled for at least one of
the updating numbers)
pCO2(limit) value for the stability criterion is 0.40 kPa (3.0 mmHg).
T T B B
1-21

T T B B T T
Stability criteria The following stability criteria must be met to obtain a stable electrode response
(continued)
T T during measurement:
= pCO 2 (sample, upd.30) pCO 2 (sample, upd.i)
For Criterion
1.33 kPa pCO 2 (sample, upd.30) pCO 2 (sample, upd.16) 0.40
>1.33 kPa 0.1
pCO 2 (sample, upd.30) pCO 2 (sample, upd.16 )
< 0.5
pCO 2 (sample, upd.16 ) pCO 2 (sample, upd.1)
For >1.33 kPa: T
if the following criteria are fulfilled, then no result is reported:
pCO 2 (sample, upd.30) pCO 2 (sample, upd.16)

< 1.0
or
0.5
Expired air samples:

TU UT
Measurement on an expired air sample is accepted if the following criterion is

fulfilled:
pCO2 (sample,upd.30) pCO2 (sample,upd.24)0.40 kPa (3.0 mmHg)
B B B B
or
pCO2 (sample,upd.30) pCO2 (sample,upd.24)0.04 pCO2 (sample,upd.30).
B B B B B B
Error message "Measurement unstable" (= pCO2 response fault during electrode

B B
monitoring in Expired air mode) is displayed if the stability criterion is not

fulfilled.
1-22
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.
Electrode jacket
The electrolyte has a constant and
known concentration of potassium ions.
When a sample is brought in contact
with the electrode, a potential develops
across the PVC and cellophane
membranes. The potential depends on
the difference between the potassium
(more precisely, activity) in the
Cellophane membrane electrolyte and the sample. If the cK+ inP P
both solutions is the same, the potential

across the electrode tip will be 0 V.
Electrode contact The Na electrode (E755) is an ion-

element is a Na+-sensitive ceramic pin
P P
contained in the tip of the jacket.

known concentration of sodium ions.
Electrode jacket When a sample is brought in contact
across the ceramic pin. The potential
depends on the difference between the
sodium (more precisely, activity) in the
electrolyte and the sample. If the cNa+ P P
in both solutions is the same, the

potential across the electrode tip will be
0 V.
1-23
Electrolyte electrodes, Continued T T
Description T
Electrode contact The Ca electrode (E733) is an ion-
(continued) T selective electrode whose sensing
a calcium-neutral ion carrier. The ion-
sensitive membrane is covered with a
cellophane membrane in order to
Electrode jacket protect it from the samples.
known concentration of calcium ions.
the difference between the calcium
Cellophane membrane
electrolyte and the sample. If the cCa2+ P P
in both solutions is the same, the

potential across the electrode tip will be
0 V.
Electrode contact The Cl electrode (E744) is an ion-
a chloride ion carrier. The ion-sensitive
membrane is covered with a cellophane
membrane in order to protect it from the
Electrode jacket samples.
known concentration of chloride ions.
the difference between the chloride
Cellophane membrane electrolyte and the sample. If the cCl in
P P
both solutions is the same, the potential

across the electrode tip will be 0 V.
1-24
Electrode chain The total potential across the electrode chain is a sum of the potential differences at
potential each of the elements in the chain, all but one of which is known and constant.
Element Potential Symbol

Ag/AgCl electrode Known and constant when the Eref
T TB B
/electrolyte solution. Ag/AgCl wire is immersed in the

(Reference electrode) electrolyte solution.
Membrane junction between Known and constant, independent EMJ
T TB B
the electrolyte solution in the of sample composition.

reference electrode and the
sample.
Ion-sensitive membrane (or Unknown, dependent on sample
T T ESample
T TB B
pin) junction separating the composition.

sample and the electrode.
Ag/AgCl electrode/inner Known and constant when the EE
T TB B
buffer solution. Ag/AgCl wire is immersed in the

(Electrolyte electrode) electrolyte solution.
Total potential. Measured by the voltmeter. Etot
T TB B
The unknown potential difference across the ion-sensitive membrane or pin is then
the difference between the measured total potential and the sum of the known
potentials:
ESample = E tot ( E ref + EMJ + E E ) mV
Nernst equation The potential difference at the membrane (or pin) in the electrolyte electrodes can
be expressed by the Nernst equation:
2.3RT
E Sample = E 0 + log a ion mV
nF
where:
E0 = standard electrode potential
R = gas constant (8.3143 J K1mol1) P P P P
T
T T = absolute temperature (310.15 K at 37 oC) P P
n
T T = charge on the ion (n = 1 for K and Na , n = 1 for Cl, n = 2 for Ca2+)
+
P P
+
P P P P P P
F = Faraday constant (96487 coulomb mol1) P P
aion = activity of the specific ion
1-25
Calibration Calibration solutions for the ABL835/30/25/20/15/10/05 FLEX analyzers have the
solution values following nominal electrolyte concentrations:
Parameter S1820 Cal 1 S1830 Cal 2
+
cK
T T P P 4.0 mmol/L 40.0 mmol/L
+
cNa
T T P P 145 mmol/L 20.0 mmol/L
cCa2+
cCl
T T P P 102 mmol/L 50 mmol/L
Calibration solutions for the ABL837/27/17 FLEX analyzers have the following
nominal electrolyte concentrations:
Parameter S1827 Cal 1 S1837 Cal 2
cK+
+
cNa
T T P P 145 mmol/L 50.0 mmol/L
2+
cCa

cCl
T T P P 102 mmol/L 50 mmol/L
The precise concentration of each electrolyte ion is contained in the solutions

barcodes.
Designations The following designations are used (X = K/Na/Ca/Cl):
E(X,Cal1) = Potential of the respective electrolyte electrode

chain from a calibration on Cal 1 solution
E(X,Cal2) = Potential of the respective electrolyte electrode
chain from a calibrration on Cal 2 solution
61.5 = Theoretical sensitivity of the K and Na electrodes at
37 oC
P P
30.75 = Theoretical sensitivity of the Ca electrode at 37 oC P P
61.5 = Theoretical sensitivity of the Cl electrode at 37 oCP P
cX(Cal1)
T T = Concentration of the respective electrolyte ion in
Cal 1 solution
cX(Cal2)
T T = Concentration of the respective electrolyte ion in
Cal 2 solution
E0(X,Cal1)
B B = Standard potential of the respective electrolyte
electrode chain
1-26
Designations
cX(Cal1,nom) = Nominal concentration of the respective electrolyte
(continued)
T T
ion in Cal 1 solution

T
E(X,Cal1,prev) = Potential of the respective electrolyte electrode chain

from the previous calibration on Cal 1 solution
Sens(X,Cal2,prev) = Sensitivity of the respective electrolyte electrode
from the last 2-point calibration
cX(Cal1,prev) Concentration of the respective electrolyte ion in
Cal 1 solution in the previous calibration
Sensitivity The sensitivity of the electrolyte electrodes is calculated from the following
equations:
K electrode
E(K, Cal1) E(K, Cal2)
Sens(K)= (fraction)
cK + (Cal1)
61.5 log
cK + (Cal2)
Na electrode
E(Na, Cal1) E(Na, Cal2)
Sens(Na)= (fraction)
cNa + (Cal1)
61.5 log
cNa + (Cal2)
Ca electrode
E(Ca, Cal1) E(Ca, Cal2)
Sens(Ca)= (fraction)
cCa 2 + (Cal1)
30.75 log
cCa 2 + (Cal2)
Cl electrode
E(Cl, Cal1) E(Cl, Cal2)
Sens(Cl)= (fraction)
cCl (Cal1)
- 61.5 log
cCl (Cal2)
The sensitivity limits of the electrolyte electrodes are as follows:

Electrode Sensitivity limits
K 92-105 %
Na 90-105 %
Ca 90-105 %
Cl 85-105 %
1-27
Status The status of each of the electrolyte electrodes is calculated from the following
equations:
K electrode
E(K,Cal1) E 0 (K,Cal1)
10 61.5 cK + (Cal1, nom) 2
Status(K) = mmol/L
cK + (Cal1)
Na electrode
E(Na,Cal1) E 0 (Na,Cal1)
10 61.5 cNa + (Cal1, nom) 2
Status(Na) = mmol/L
cNa + (Cal1)
Ca electrode
E(Ca,Cal1) E 0 (Ca,Cal1)
10 30.75 cCa 2 + (Cal1, nom) 2
Status(Ca) = mmol/L
cCa 2 + (Cal1)
Cl electrode
E(Cl,Cal1) E 0 (Cl,Cal1)
10 -61.5 cCl (Cal1, nom) 2
Status(Cl) = mmol/L
cCl (Cal1)
The status limits of the electrolyte electrodes are as follows:

Electrode Status Limits
K 0.5-12 mmol/L
Na 10-250 mmol/L
Ca 0.1-20 mmol/L
Cl 30-900 mmol/L
Drift Drift equations are given below.

K electrode
E(K,Cal1) E(K,Cal1,prev)
Drift 1(K) = 10 61.5Sens(K,prev)

cK + (Cal1, prev) cK + (Cal1) mmol/L
E(K,Cal2)- E(K,Cal1,prev)
Drift 2(K) = 10 61.5Sens(K,prev)

cK + (Cal1, prev) cK + (Cal2) mmol/L
1-28
Drift (continued) Na electrode

T T
E(Na,Cal1) E(Na,Cal1,prev)
Drift 1(Na) = 10 61.5Sens(Na,prev)

cNa + (Cal1, prev) cNa + (Cal1) mmol/L
E(Na,Cal2)- E(Na,Cal1,prev)
Drift 2(Na) = 10 61.5Sens(Na,prev)

cNa + (Cal1, prev) cNa + (Cal2) mmol/L
Ca electrode
E(Ca,Cal1) E(Ca,Cal1,prev)
Drift 1(Ca) = 10 30.75Sens(Ca, prev)

cCa 2 + (Cal1, prev) cCa 2+ (Cal1) mmol/L
E(Ca,Cal2)- E(Ca,Cal1,prev)
Drift 2(Ca) = 10 30.75Sens(Ca, prev)

cCa 2+ (Cal1, prev) cCa 2 + (Cal2) mmol/L
Cl electrode
E(Cl,Cal1) E(Cl,Cal1,prev)
Drift 1(Cl) = 10 -61.5Sens(Cl,prev)

cCl (Cal1, prev) cCl (Cal1) mmol/L
E(Cl,Cal2)- E(Cl,Cal1,prev)
Drift 2(Cl) = 10 -61.5Sens(Cl,prev)

cCl (Cal1, prev) cCl (Cal2) mmol/L
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
T T T T
electrolyte ion. T T
The default drift tolerances set by Radiometer are as follows:

Electrode Drift 1 tolerances Drift 2 tolerances
K 0.2 mmol/L 1.5 mmol/L
Na 3 mmol/L 1 mmol/L
Ca 0.05 mmol/L 0.2 mmol/L
Cl 2 mmol/L 3 mmol/L
Measurement The electrolyte concentration in a sample is calculated from the following

equation:
E(X,sample)- E(X,Cal, prev)
Sens(theo)Sens(X, prev )
cX(sample)=cX(Cal 1) 10
where:
E(X,sample) = potential of the electrolyte electrode chain from a
measurement on the sample.
E(X,Cal,prev) = potential of the electrolyte electrode chain from the
previous calibration on Cal 1 solution.
cX(Cal 1) =
T T B B
specific (true) concentration of the electrolyte ion in Cal 1
solution.
1-29
Measurement
Sens(theo) = theoretical sensitivity of the electrolyte electrode.
(continued)
Sens(X,prev) = relative sensitivity of the electrolyte electrode chain from
T
the last 2-point calibration
Corrections The measured electrolyte concentration is then corrected for systematic deviations
from the reference method by the following equations:
Equation A:
T
cX(sample, corr)macromode = A0,macromode cX(sample) macromode + A1,macromode

T T B B B B B B B B
and
Equation B:
T T
T cX(sample,corr)micromode = A0,micromode cX(sample,corr) macromode + A1,micromode

T B B B B B B T T B B B B
where
cX(sample)
T T = uncorrected value of the electrolyte ion in the sample
cX(sample,corr) = corrected value of the electrolyte ion in the sample
T T
A0 B B = instrument-dependent correction factor

A1 B B = instrument-dependent correction cut-off
Chloride is corrected for cHCO 3 interference. The default value cHCO 3 = 24.5
mmol/L is used in
Equation C:
T
cCl(sample,corr)macromode = A0,macromode (cCl(sample) 0.0956 cHCO3) +

P P B B B B P P B PB P
+A1,macromode B B
Note that subscript "macromode" in the equations above is used for the sake of
convenience and stands for S250, "FLEXMODE (no message)".
1-30
Corrections Corrections for cNa+:

T T T P P
(continued)
T T
ABL8xx
T Mode
T T T A0
B TB T A1
B TB Equation
T T
FLEX T
37/27/17 S250 1.0307 -8.104 A

C125 1.0307 -8.104 A
*FM (message 903) 1.0123 1.3284 A, B
*FM (message 902) 1.0123 1.3284 A, B
*FM (message 901) 1.0123 1.3284 A, B
*FM (message 900) 1.0123 1.3284 A, B
*FM (message 899) 1.0123 1.3284 A, B
*FM (message 898) 1.0123 1.3284 A, B
35/25/15 S195 0.995 -3.00 A
S95 1.01 1.80 A, B
C95 1.03 -1.09 A, B
*FM (no message) 0.995 -3.00 A
*FM (message 897) 1.030 -1.00 A, B
*FM (message 895) 1.030 -1.00 A, B
05 S165 0.995 -3.00 A
S95 1.01 1.80 A, B
C95 1.03 -1.09 A, B
*FM (message 895) 1.03 -1.00 A, B
*FM (message 897) 1.03 -1.00 A, B
00 BASIC S195 0.995 -3.00 A
S95 1.01 1.80 A, B
C95 1.03 -1.09 A, B
1-31
Corrections Corrections for cK+:

T T T P P
(continued)
T T
ABL8xx
T T Mode T T A0
B TB A1
T B TB T Equation T
FLEX T
37/27/17 S250 0.9784 -0.1163 A

C125 0.9784 -0.1163 A
*FM (message 903) 1.0462 -0.1101 A, B
*FM (message 902) 1.0462 -0.1101 A, B
*FM (message 901) 1.0462 -0.1101 A, B
*FM (message 900) 1.0462 -0.1101 A, B
*FM (message 899) 1.0462 -0.1101 A, B
*FM (message 898) 1.0462 -0.1101 A, B
35/25/15 S195 0.985 -0.065 A
S95 1.05 -0.13 A, B
C95 1.11 -0.37 A, B
*FM (no message) 0.985 -0.065 A
*FM (message 897) 1.11 -0.37 A, B
*FM (message 895) 1.11 -0.37 A, B
05 S165 0.985 -0.065 A
S95 1.05 -0.13 A, B
C95 1.11 -0.37 A, B
*FM (no message) 0.985 -0.065 A
*FM (message 897) 1.11 -0.37 A, B
*FM (message 895) 1.11 -0.37 A, B
00 BASIC S195 0.985 -0.065 A
S95 1.05 -0.13 A, B
C95 1.11 -0.37 A, B
*FM = FLEXMODE

T
1-32
Corrections Corrections for cCa2+:

T T T P P
(continued)
T T
ABL8xx
T T Mode T A0
T B TB A1
T B TB T Equation T
FLEX T
37/27/17 S250 1.0108 -0.0396 A

C125 1.0108 -0.0396 A
*FM (message 903) 1.0584 -0.001 A, B
*FM (message 902) 1.0584 -0.001 A, B
*FM (message 901) 1.0584 -0.001 A, B
*FM (message 900) 1.0584 -0.001 A, B
*FM (message 899) 1.0584 -0.001 A, B
*FM (message 898) 1.0584 -0.001 A, B
35/25/15 S195 1.004 -0.022 A
S95 1.05 -0.004 A, B
C95 1.08 -0.04 A, B
*FM (no message) 1.004 -0.022 A
*FM (message 897) 1.08 -0.04 A, B
*FM (message 895) 1.08 -0.04 A, B
05 S165 1.004 -0.022 A
S95 1.05 -0.004 A, B
C95 1.08 -0.04 A, B
*FM (no message) 1.004 -0.022 A
*FM (message 897) 1.08 -0.04 A, B
*FM (message 895) 1.08 -0.04 A, B
00 BASIC S195 1.004 -0.022 A
S95 1.05 -0.004 A, B
C95 1.08 -0.04 A, B
1-33
T Corrections for cCl-:

T T P P
ABL8xx
T T Mode T A0
T B TB A1
T B TB T Equation T
FLEX T
37/27/17 S250 1.2715 -36.048 C

C125 1.2715 -36.048 C
*FM (message 903) 0.9682 3.4529 C, B
*FM (message 902) 0.9682 3.4529 C, B
*FM (message 901) 0.9682 3.4529 C, B
*FM (message 900) 0.9682 3.4529 C, B
*FM (message 899) 0.9682 3.4529 C, B
*FM (message 898) 0.9682 3.4529 C, B
35/25/15 S195 1.225 -30.7 C
S95 1.000 0.0 C, B
C95 1.01 -1.7 C, B
*FM (no message) 1.225 -30.7 C
*FM (message 897) 1.01 -1.7 C, B
*FM (message 895) 1.01 -1.7 C, B
05 S165 1.225 -30.7 C
S95 1.000 0.0 C, B
C95 1.01 -1.7 C, B
*FM (no message) 1.225 -30.7 C
*FM (message 897) 1.01 -1.7 C, B
*FM (message 895) 1.01 -1.7 C, B
00 BASIC S195 1.225 -30.7 C
S95 1.000 0.0 C, B
C95 1.01 -1.7 C, B
*FM = FLEXMODE
1-34
during calibration:
cX(Cal, upd.last) cX(Cal, upd.i) K cX(Cal, upd.last)
This criterion is valid for calibrations using Cal 1 and Cal 2 solutions where:
cX(Cal,upd.last) =
T T Concentration of the electrolyte ion from the last updating
when measuring on calibration solution. (The last
updating is number 30.)
cX(Cal,upd.i) =
T T Concentration of the electrolyte ion for a given updating
when measuring on calibration solution. (The relationship
must be fulfilled for at least one of the updating numbers
18 or 19.)
K= Constant for the stability criterion.
Electrolyte ion
T T Cal 1 solution
T T T Cal 2 solution T
K+ P P 0.01 0.01
Na+ P P 0.01 0.02
2+
Ca P P 0.02 0.02

Cl P P 0.022 0.022
during measurement:
cX(sample, upd.last) cX(sample, upd.i)

K ( cX(sample, upd.last ) cX ( Rinse) + cX ( Rinse) )
where:
cX(sample,upd.last) =
T T Concentration of the electrolyte ion from the median
of the last five updatings (for Ca2+: Three last P P
updatings) when measuring on a sample. The last

updating number is 30 (or 10 for some micromodes).
cX(sample,upd.i)
T T = Concentration of the electrolyte ion for a given
updating when measuring on a sample. (The
relationship must be fulfilled for at least one of the
updating numbers shown below.)
K+P P Na+ P P Ca2+
P P
Cl P P
22 22 26 22
23 23 27 23
In some micromodes, substract 20 from number
above.
1-35
Stability criteria
K Constant for the stability criterion; it equals to:
(continued)
T
K+ = 0.012; Na+ = 0.012; Ca2+ = 0.022; Cl = 0.012

P P P P P P P P
cX Rinse Constant used indicates the concentration of the

electrolyte ion level in the Rinse Solution:
K+ = 4.0; Na+ = 130.0; Ca2+ = 1.25; Cl = 137.7
P P P P P P P P
1-36
References
List of Linnet N. pH measurements in theory and practice. 1st ed. Copenhagen:

references Radiometer Medical A/S, 1970.
1-37
1-38
2. Amperometric measuring principles
Overview
Introduction This chapter describes the amperometric measuring principles and the pO2, B B
Glucose, Lactate and Crea electrodes that are based on this principle.

X X
pO2 electrode....................................................................................................
B B 2-4
X X
Glucose and Lactate electrodes ........................................................................ 2-13 X X
Crea electrodes ................................................................................................. 2-23

X X
References ........................................................................................................ 2-31

X X
2. Amperometric measuring principles ABL800 FLEX reference manual
General information
Amperometric The magnitude of an electrical current flowing through an electrode chain, which
method is in turn proportional to the concentration of the substance being oxidized or
reduced at an electrode in the chain
The electrode chain in amperometric measurements consists of the sample, the two
electrodes (anode and cathode), an ammeter, a voltage source, the membranes and
the electrolyte solutions.
Ammeter
Applied voltage
Anode Cathode
Electrolyte solution
Membrane
Sample
Part Function
Cathode Negative electrode where a reduction reaction occurs and
electrons are consumed.
Anode Positive electrode where an oxidation reaction occurs and
electrons are released.
Electrolyte Provides electrical contact between the anode and cathode.
solution
Membrane Allows the appropriate molecules to pass through from the
sample.
Sample Contacts the membrane.
Applied voltage Applies the necessary potential for the reduction or oxidation
reaction under study.
Ammeter Measures the current flowing through the circuit.
To simplify the description of the measuring process in an amperometric electrode,

we make the following assumptions:
there is a species A in the sample which is reduced at the cathode to A.
T T T P TP
there is a species X in the electrolyte which is oxidized at the anode to X+.

T T T P TP
2-2
ABL800 FLEX reference manual 2. Amperometric measuring principles
General information, Continued T
Amperometric The membrane is selective to the species A, allowing no other species but it to pass
T T
method through from the sample into the electrolyte solution.

(continued)
As an appropriate potential is applied across the electrodes, the species A is
T T
T T
reduced at the cathode according to the following reaction:

A + e A
P P P
The reduction of A produces a flow of electrons, i.e. an electrical current.

T T
To complete the electrical circuit an oxidation reaction where electrons are

released is necessary. Therefore species X is oxidized according to the following
T T
reaction:
X X+ + e P P P
The magnitude of the current flowing through the circuit is proportional to the
concentration of the species being reduced, in this case species A. The analyzer T T
thereby automatically calculates the concentration of A in the sample. T T
The amperometric measuring principle is applied in the pO2, Glucose, Lactate, B B
Crea A and Crea B electrodes.
Calibration The electrodes are active elements and must be calibrated regularly as the signals
from the electrodes change with, e.g. age or deposits on the membrane.
Calibration relates the electrode signals during the calibration sequence to the
values of the calibrating solutions and must be performed at regular intervals so
that the accuracy can be constantly refined after inevitable minor changes in the
electrodes behavior.
Actual electrode condition is described by zero point and sensitivity and compared
with theoretical conditions for an "ideal" electrode. In addition to zero point and
sensitivity, an electrode condition is described by drift.
Calibration The following calibration materials are used:

material
Gas 1 and Gas 2: each gas has a precise composition Calibration of the pO2 B B
essential for determining the accuracy of the analyzer in electrode

each pO2 measurement.
B B
Calibration Solution 1 Calibration of the

Glucose, Lactate and
Crea B electrodes
Calibration Solution 2 Calibration of the
Crea A and Crea B
electrodes
2-3
pO2 electrode
T T B B
Description The pO2 electrode is an amperometric electrode which consists of a silver anode,
B B
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.
Electrode contact
The electrode chain is polarized
with a constant voltage of -630
mV.
Oxygen from the sample diffuses
across the membrane into the
electrolyte and is reduced on the
Electrode jacket cathode (electrons are consumed)
according to the following
equation:
Electrolyte O2 + 4H+ + 4e 2H2O B B P P P P B B
AgCl reference band The H+ ions come from the P P
electrolyte solution.
This represents the complete
reduction of O2. Some of the O2, B B B B
however, is only partially reduced

Membrane
according to the following
equation:
O2 + 2H+ + 2e H2O2
B B P P P P B B B B
In the presence of Pt-black, H2O2 produced by the incomplete reduction of O2 at

B B B B B B
the cathode is immediately decomposed:

2H2O2 2H2O + O2 B B B B B B B B
This oxygen is then also reduced at the cathode. The reduction of oxygen produces
a flow of electrons (an electrical current) the size of this current, I, proportional to
the amount of oxygen and measured by the ammeter:
I = Sens(pO2) pO2 + Io pA T T B B B B T TB B
where:
Sens(pO2) = B B sensitivity of the pO2 electrode B B
pO2 B B = partial pressure of O2 in the sample B B
Io
T TB B = zero current, i.e. the current flowing through the circuit when
pO2 = 0 kPa (mmHg)
B B
To complete the electrical circuit, an oxidation reaction where electrons are

released is necessary. The reaction at the silver anode is the conversion of Ag to
Ag+: P P
Ag Ag+ + e P P P P
In order to maintain a charge balance between the anode and cathode, four atoms
of Ag need to be oxidized for one molecule of O2 to be reduced. B B
2-4
pO2 electrode, Continued

T T B B T T
Description The Ag+ ions are released into the electrolyte solution where they react with the
P P
(continued)
T
Cl ions present, producing AgCl which is insoluble and forms a layer on the silver
P P
rod:
Ag+ + Cl AgCl
P P P P
Not all Ag+ ions can be removed from the solution. Some reach the cathode where
they are converted back to Ag and form a deposit of silver. This deposit must be
periodically removed with the brush provided in the electrode box.
Designations The following designations are used to describe sensitivity, zero point and drift:
I(O2,Gas1) B B
= Current recorded at the pO2 electrode from a measurement on

B B
Gas 1
I(O2,Gas2) B B
= Current recorded at the pO2 electrode from a measurement on

B B
Gas 2
pO2(Gas1)B B
= Partial pressure of O2 in Gas 1

B B
pO2(Gas2)B B
= Partial pressure of O2 in Gas 2

B B
FO2 (Gas1)
T T B B = Fraction of O2 in Gas 1
B B
FO2 (Gas2)
T T B B = Fraction of O2 in Gas 2
B B
B
T T
= Ambient pressure
pH 2 O = Water vapor pressure = 6.2571 kPa at 37 oC. P P
Sens(pO2, B B
= Sensitivity of the pO2 electrode measured at the previous 2-

prev)
B B
point calibration
I(O2,Gas2, B B
= Current recorded at the pO2 electrode from the previous

prev)
B B
Sensitivity The pO2 electrode is calibrated on two gases with known O2 content.
B B B B
Gas 1 contains 19.76 % O2 and Gas 2 contains 0.0 % O2. B B B B
The exact composition of the calibration gases is contained in their barcodes.

The sensitivity of the pO2 electrode, Sens(pO2), is calculated as follows: B B B B
I(O 2 , gas1) I(O 2 , Gas2)

Sens( pO 2 ) = pA/kPa
pO 2 (gas1) pO 2 (Gas2)
2-5

T T B B T T
Sensitivity The partial pressures of O2 in the gas mixtures Gas 1 and Gas 2 are calculated from
B B
(continued)
T T the following equation:
pO 2 (gas1) = FO 2 (Gas1) [B pH 2 O] kPa
pO 2 (gas2) = FO 2 (Gas2) [B pH 2 O] kPa
The sensitivity of the pO2 electrode should fall between 5-40 pA/mmHg or 37.5-
B B
300 pA/kPa.
Zero point The zero point of the pO2 electrode is the electrode current at pO2 = 0. It is
B B B B
calculated from the current measured at the electrode with Gas 2 (0 % O2), and the B B
sensitivity:
I(O 2 , Gas2)
Zero point(pO 2 )= kPa
Sens( pO 2 , prev)
The zero point value of the pO2 electrode should be less than 6.0 mmHg or 0.80 kPa.
B B
The zero point current is the current measured at the pO2 electrode with Gas 2 in B B
the measuring chamber. When the measurement on Gas 2 begins, a relatively high
current is recorded due to residual O2 from the Rinse Solution in the measuring
B B
chamber. This current falls exponentially with time while Gas 2 is present in the
measuring chamber.
Forty seconds into the measurement the Current (pA)
current reaches a steady state which is

then considered as the zero point
current.
Time (secs)
Drift Drift 1 is a measurement of the difference between two consecutive measurements

on Gas 1, and is calculated from the following equation:
I(O 2 , Gas1) I(O 2 , Gas1, prev) )
Drift 1( pO 2 ) = pO 2 (Gas1) kPa
Sens( pO 2 , prev)
Drift 2 reflects the change in sensitivity between 2-point calibrations and is
calculated from the following equation:
I(O 2 , Gas2) I(O 2 , Gas2, prev) )
Drift 2( pO 2 )= pO 2 (Gas2) kPa
Sens( pO 2 , 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.
2-6

T T B B T T
Measurement The pO2 value for a sample is calculated from the following equations:
T T B B
I(O 2 , sample, upd.i) I(O 2 , Gas2, prev)

pO 2 (sample, upd.i) = K1
Sens( pO 2 )
Constant K1 describes the gas/liquid relationship for the electrode.
B B
This constant is defined as:

Sens( pO 2 )
K 1 = 1+ 0.01 58370
. + 21712
. +
3.66294
= pO 2 (sample, upd.30) pO 2 (sample, upd.1)
pO 2 (sample, upd.6) pO 2 (sample, upd.30) ( pO 2 (sample, upd.18) )

2
predict =
pO 2 (sample, upd.6) + pO 2 (sample, upd.30) 2 pO 2 (sample, upd.18)
where:
I(O2,sample,updi) = B B current recorded at the pO2 electrode from updating
T T B B
number i with a measurement on the sample

T T
I(O2,Gas2,prev) = B B current recorded at the pO2 electrode from the previous

T T B B
Sens(pO2) = B B relative sensitivity of the pO2 electrode determined T T B B
from the last calibration on Gas 1 and Gas 2

= difference between pO2(sample) from the first and last
T T B B
updatings
predict = extrapolated value for pO2 T T B B
For < 2.66 kPa,

T T
pO2(sample) = pO2(sample, upd.30)

T T B B T T B B
For 2.66 kPa < < 5.32 kPa

T T
predict ( 2.66) + pO 2 (sample, upd.30) (5.32 )

pO 2 (sample) =
2.66
For 5.32 kPa
T T
pO2(sample) = predict T T B B
2-7

T T B B T T
Corrections Gas/liquid relationship:

T T
blood samples
K1 is a constant that describes the gas/liquid relationship for the electrode. The
B B
constant is defined as follows:
1 Sens( pO 2 )
K1 = 1 + 5.8370 + 21.712 +
100 3.66294
The pO2 measured from the sample is then corrected for systematic deviations
T T B B
from the reference method using the following equation:

Equation A:
T
pO 2 (sample,corr) =
(
d 1 + d 12 4 e2 + e3 pO 2 (sample, v1) + e4 pO 2 (sample, v1) 2 )
2
where:
pO2 value of the sample after the first part of correction is as follows:
T T B B
4
pO 2 (sample, v1) = pO 2 (sample) + (k1 k 2 e k3 pO 2 (sample) ) (100.398 B)
and:
d1 B B
= e0 pO2(sample, v1) + e1
B B T T B B B B
k1
T TB B
= correction constant = 0.02614
k2
T TB B
= correction constant = 0.02107
k3
T TB B = correction constant = 0.00281
e0, e1, e2, e3, e4
B B B B B B B B B B
= correction constants
B = barometric pressure in kPa
Equation A+:
T
constants for the macoromodes S250 and FLEXMODE (C195 and 165) with no
message. Then the obtained results are put back into equation A as pO2(sample) B B
and then treated again, using the constants for the specific mode.
Or
Equation B:
T
constants for the macoromodes S250 and FLEXMODE (C195 and 165) with no
message. Then the obtained results are put back into equation B as pO2(sample) B B
and then treated again, using the constants for the specific mode.
cX(sample,corr) = A0 cX(sample) + A1
T T B B T T B B
2-8

T T B B T T
Corrections
blood samples
(continued)
T T
TABL Mode
T T e0
B B e1
B B e2
B B e3
B B e4
B B A0B B A1B B Eq.
8xx
FLEX T
37/27/ S250 -2.3618 7.05686 0.92629 -7.16718 1.36413 A

17 C125 -2.3618 7.05686 0.92629 -7.16718 1.36413 A
*FM (message 903) 1.0102 0.0431 A, B
*FM (message 902) 1.0102 0.0431 A, B
*FM (message 901) 1.0102 0.0431 A, B
*FM (message 900) 1.0102 0.0431 A, B
*FM (message 899) 1.0102 0.0431 A, B
*FM (message 898) 1.0102 0.0431 A, B
35/25/ S195 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
15 S95 1.020 -0.200 A, B
S85 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
C95 0.9965 -0.0254 A, B
C55 -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
*FM (no message) -2.30300 5.96942 0.83281 -6.07310 1.30565 A
*FM (message 897) 0.9965 -0.0254 A, B
*FM (message 895) 0.9965 -0.0254 A, B
*FM (message 894) 0.9965 -0.0254 A, B
*FM (message 873) 0.9965 -0.0254 A, B
*FM (message 872) -2.20159 5.70807 -0.41342 -5.42718 1.19023 A, A+
*FM (message 871) -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
30/20/ S85 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
10/10 C55 -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
BG *FM (no message) -2.30300 5.96942 0.83281 -6.07310 1.30565 A
only *FM (message 872) -2.19314 5.81012 -0.96320 -5.46921 1.18037 A, A+
*FM (message 871) -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
2-9

T T B B T T
Corrections
blood samples
T(continued)T
(continued)
T
ABL Mode e0
B B e1
B B e2
B B e3
B B e4
B B A0
B B A1B B Eq.
8xx
FLEX
05 S165 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
S95 1.020 -0.200 A, B
S85 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
C95 0.9965 -0.0254 A, B
C55 -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
*FM (no message) -2.30300 5.96942 0.83281 -6.07310 1.30565 A
*FM (message 897) 0.9965 -0.0254 A, B
*FM (message 895) 0.9965 -0.0254 A, B
*FM (message 894) 0.9965 -0.0254 A, B
*FM (message 873) 0.9965 -0.0254 A, B
*FM (message 872) -2.20159 5.70807 -0.41342 -5.42718 1.19023 A, A+
*FM (message 871) -2.1199 4.7210 -1.0156 -4.2974 1.1035 A, A+
00 S195 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
BASIC S95 1.020 -0.200 B
S85 -2.30300 5.96942 0.83281 -6.07310 1.30565 A
C95 0.9965 -0.0254 B
C55 -2.1199 4.7210 -1.0156 -4.2974 1.1035 A+
*FM = FLEXMODE
2-10

T T B B T T
Corrections The pO2 measured from the sample is then corrected for systematic deviations
T T B B
expired air from the reference method using the following equation:
samples
pO 2 (sample, corr) = A 0 pO 2 (sample) + A 1 ( B pH 2 O)
where:
pO2(sample)
T T B B = uncorrected pO2 value of an expired air sample
T T B B
pO2(sample,corr)
T T B B = corrected pO2 value of an expired air sample
T T B B
A0 B B
A1 B B
B
T T
= barometric pressure during the measurement
pH2O
T T B B
= partial pressure of saturated water vapour = 6.2571 kPa
ABL8xx FLEX
T T Mode
T T A0
T B TB A1
T B TB T Equation
T
All FLEX and BASIC Expired air 1.016 -0.004 A
When measuring on gas samples, the constant K1 (describes the gas/liquid B B
relationship for the electrode) is equal to 1.
during calibration: T T
pO 2 (sample, upd.last) pO 2 (sample, upd.i) pO2 (limit) B B
This criterion is valid for 1-point calibrations (Gas 2 contains no oxygen) where:
2-11

B B T T
Stability criteria
(continued)
T T
Parameter pO2 value from the last updating number...
B B
ABL8x5/8x7 FLEX/00 BASIC

T T ABL8x0 FLEX
T T
pO2(Gas1,upd.last)
B B 92 62
pO2(Gas1,upd.i)
B B 86 or 87 56 or 57
(the relationship must be fulfilled for at least one of
the updating numbers)
pO2(limit) value for the stability criterion is 0.80 kPa/6.0 mmHg.

T T B B
The following stability criteria must be met in order to obtain a stable electrode
response during measurement: T T
=|pO2(sample,upd.30) pO2(sample,upd.1)|
B B B B
For Criterion
2.66 kPa pO 2 (sample) pO 2 (sample, upd.16) 0.80
> 2.66 kPa pO 2 (sample, upd.30) pO 2 (sample, upd.18)

0. 2 < 0. 6
pO 2 (sample, upd.18) pO 2 (sample, upd.6)
For > 2.66 kPa: T
if the following criteria are fulfilled, then no result is reported:

< 1.0
or

0 .6
Expired air samples:

TU UT
Measurement on an expired air sample is accepted if the following criterion is

fulfilled:
pO2 (sample,upd.30) pO2 (sample,upd.24)0.80 kPa/6.0 mmHg,
B B B B
or
pO2 (sample,upd30) pO2 (sample,upd.24)0.05 pO2 (sample,upd.30).
B B B B B B
Error message "Measurement unstable" (= pO2 response fault during electrode B B
monitoring in Expired air mode) is displayed if the stability criterion is not

fulfilled.
2-12
Glucose and Lactate electrodes

Description
The Glucose electrode (E7066) and the
Electrode contact Lactate electrode (E7077) have a
similar construction described below.
The electrode consists of a silver
cathode and a platinum anode. The
electrode is protected by an electrode
jacket filled with electrolyte solution
Electrode jacket and a multilayer membrane mounted at
the tip.
The membrane consisting of three
Electrolyte layers:
AgCl reference band 1. outer membrane layer permeable to
glucose/lactate.
2. middle enzyme layer.
Multilayer membrane 3. inner membrane layer permeable to
H2O2. B B B B
A polarization voltage of 675 mV is

applied to the electrode chain and the
current through the chain is measured
by an ammeter.
Glucose or lactate molecules are
Electrode contact
transported across the outer membrane
of the multilayer membrane.
The enzyme glucose oxidase or lactate
oxidase immobilized between the inner
and outer membrane layers converts the
glucose or lactate according to the
Electrode jacket following reactions:
glucose + O2 gluconic acid + H2O2 B B B B B B
lactate + O2 pyruvate + H2O2 B B B B B B
Electrolyte
O2 for this reaction is supplied by the
B B
AgCl reference band

outer membrane layer and also by the
oxidation of H2O2 at the Pt anode. B B B B
The H2O2 produced by the enzyme

B B B B
Multilayer membrane reaction is transported across the inner

membrane to the Pt anode.
2-13
Glucose and Lactate electrodes, Continued T T
Description
(continued)
T T
H2O2 2H+ + O2 + 2e
B B B B P P B B P P
When a potential is applied to the electrode

chain, the oxidation of H2O2 produces an B B B B
electrical current proportional to the

amount of H2O2, which in turn is directly B B B B
related to the amount of glucose or lactate.

To complete the electrical circuit a
reduction reaction (where electrons are
consumed) at the cathode converts Ag+ P P
(from AgCl) to Ag:

Ag+ + e Ag
P P P P
In order to maintain a charge balance between the anode and the cathode, two Ag+ P P
ions need to be reduced for one molecule of H2O2 to be oxidized. B B B B
Zero current The zero current is a small background current measured at the electrode when no
glucose or lactate is present in a solution. As the Rinse Solution contains no
glucose or lactate, a baseline representing the zero current, I0 as a function of time B B
(I0 = f(t)), is obtained from continuous measurements on the rinse solution.

B B
I
(current)
Extrapolated
Rinse x x xx x x x x x baseline
x x x x
I0(t)
I0(t)
tmean Time
tfinal
N measurements of I0
on the Rinse Solution
This I0 baseline is obtained as follows:

B B
At the end of a rinse, with the Rinse Solution in the measuring chamber, zero
current of the metabolite electrodes is measured periodically (the intervals
between these measurements become longer if the analyzer is idle)
The previous N (N = 8) measurements on the Rinse Solution before a calibration
or a sample measurement starts are used to obtain a baseline representing the time
function of I0 B B
2-14
Zero current The baseline is extrapolated thoughout the whole electrode calibration or sample
(continued)
T T
measurement period, and represents the zero current time function
The I0 baseline is used to determine the sensitivity of the metabolite electrode
B B
The extrapolated final zero current value at the metabolite electrodes at the last
updating (illustrated by the I0 baseline) is determined as follows: B B
I 0 (final)=A1 I slope (t final t mean )+ I 0 (mean) pA

where:
A1
T TB B = empirical constant dependent on electrode and determined from
tests against the reference method
tfinal
B B = time of the last measurement updating on the calibration solution
or sample
tmean
B B = the mean time of the N zero current measurements on the rinse
solution:
N
t n =1
n
t mean = sec
N
where tn is the time of the nth measurement on the rinse solution.
B B P P
I0(mean)
B B = the zero current at the mean time (tmean): B B
I
n =1
0, n
I 0 (mean) = pA
N
where I0,n is the zero current at the nth measurement on the rinse
B B P P
solution
Islope
B B = the slope or gradient of the I0 baseline B B
(t n t mean ) (I 0,n I 0 (mean))

I slope = n =1
2
pA/second
N
(t
n =1
n t mean )
If Islope > 0.0, it is set to 0.0

B B
The zero current of the metabolite electrodes should be less than 10,000 pA.
2-15
Sensitivity The sensitivities of the metabolite electrodes are calculated by measuring the
current on Calibration Solution 1 (Cal 1) and then correcting for the zero current
using the extrapolated I0 baseline. B B
Cal 1 has a nominal glucose concentration of 10 mmol/L and a nominal lactate

concentration of 4 mmol/L. The precise values are batch-individual and contained
in the barcodes of the Cal 1 bottles.
The diagram below describes in principle how the sensitivities for the metabolite
electrodes are obtained.
I
I(Cal 1,upd.N)
Electrode updatings
I(Cal 1)
Extrapolated
baseline
I(Cal 1,upd.2)
x x xx x x x x I(Cal 1,upd.1
x x x x x

I0(final)
t
N measurements of I0 Start of End of
on rinse solution Calibration Calibration
The current at the metabolite electrodes with Cal 1 in the measuring chamber,
I(Cal 1), is measured 30 times at regular intervals. The current at the 15th updating
B B
is used to determine sensitivity of the glucose electrode, and the current at the 30th
updating is used to determine sensitivity of the Lactate electrode.
The current due to the glucose or lactate presence in the sample is then calculated
as the difference between the current at the final updating (the 15th for the glucose
and the30th for the Lactate electrode) and the zero current at that time point:
I(Cal 1) = I(Cal 1,final) I0(final) B B T
The sensitivities of the electrodes are calculated as follows:

I(Cal 1)
Sens =
cX(Cal 1)
T T
2-16
Sensitivity where:
(continued)
cX(Cal 1) = actual concentration of glucose/lactate in the Cal 1 solution
I0(final)
B B = extrapolated final zero current value of the metabolite
electrode at the time of the last updating
I(Cal 1)
T T =
T T T electrode current due to presence of glucose/lactateT
The sensitivity limits of the metabolite electrodes are as follows:
Electrode Sensitivity limits

Glucose 100-1800 pA/mM
Lactate 150-2000 pA/mM
Drift The drift in the sensitivity of the metabolite electrodes is calculated from the
following equations:
I(Cal 1, final) I 0 (final)

Drift = cX(Cal 1)
Sens
where:
I(Cal 1,final) = current at the final measurement on Cal 1 solution.
Sens = sensitivity of the glucose/lactate electrode from the previous
calibration.
cX(Cal 1) = actual concentration of glucose/lactate in the Cal 1 solution.
I0(final)
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.
2-17
Measurement The glucose/lactate concentration in a sample is calculated from the following

equation:
I(sample) I 0 (final)
cX(sample) =
Sens
where:
I(sample) = current of the metabolite electrode measured on the sample

I0(final)
electrode at the time of the last sample updating
Sens = relative sensitivity of the metabolite electrode
Corrections The measured metabolite concentration is corrected for systematic deviations from
the reference method by the following equations:
Equation A:
T
cX(sample, corr)macromode = A0,macromode cX(sample) + A macromode

B B B B B B
and
Equation B:
T T
cX(sample,corr)micromode = A0,micromode cX(sample,corr) macromode + A1,micromode

B B B B B B B B B
where:
cX(sample) = uncorrected measured metabolite concentration from a sample

cX(sample, = corrected measured metabolite concentration from a sample
corr)
A0 B B
A1 B B
= instrument-dependent cut-off
constants for the macromode. Then the obtained results are put back into equation
B as cX(sample) and then treated again, using the constants for the specific mode.
Note that subscript "macromode" in the equations above is used for the sake of
convenience and stands for S250, "FLEXMODE (no message)".
2-18
Glucose and Lactate electrodes, Continued T
Corrections Corrections for cGlu:

T T T T
(continued) ABL8xx Mode A0

B B A1
B B Equation
FLEX
37/27/17 S250 0.937 -0.029 A
C125 0.937 -0.029 A
C35 1.175 -0.05 A, B
*FM (message 903) 1.00 0.00 A, B
*FM (message 902) 1.00 0.00 A, B
*FM (message 901) 1.00 0.00 A, B
*FM (message 900) 1.00 0.00 A, B
*FM (message 899) 1.00 0.00 A, B
*FM (message 898) 1.00 0.00 A, B
35/25/15 S195 0.94 0.1 A
S95 1.00 0.0 A, B
C95 1.06 0.0 A, B
C35 1.16 0.0 A, B
*FM (no message) 0.94 0.1 A
*FM (message 897) 1.06 0.0 A, B
*FM (message 895) 1.06 0.0 A, B
*FM (message 894) 1.06 0.0 A, B
*FM (message 873) 1.06 0.0 A, B
05 S165 0.94 0.1 A
S95 1.00 0.0 A, B
C95 1.06 0.0 A, B
C35 1.16 0.0 A, B
*FM (no message) 0.94 0.1 A
*FM (message 897) 1.06 0.0 A, B
*FM (message 895) 1.06 0.0 A, B
*FM (message 894) 1.06 0.0 A, B
*FM (message 873) 1.06 0.0 A, B
00 BASIC S195 0.94 0.1 A
S95 1.00 0.0 A, B
C95 1.06 0.0 A, B
C35 1.16 0.0 A, B
2-19
Corrections Corrections for cLac:

T T
(continued)
ABL8xx Mode A0
B B A1
B B Equation
FLEX
37/27/17 S250 0.97 -0.04 A
C125 0.97 -0.04 A
C35 1.202 -0.01 A, B
*FM (message 903) 0.99 0.07 A, B
*FM (message 902) 0.99 0.07 A, B
*FM (message 901) 0.99 0.07 A, B
*FM (message 900) 0.99 0.07 A, B
*FM (message 899) 0.99 0.07 A, B
*FM (message 898) 0.99 0.07 A, B
35/25/15 S195 0.97 -0.04 A
S95 1.03 0.03 A, B
C95 1.03 0.18 A, B
C35 1.13 0.05 A, B
*FM (message 897) 1.03 0.18 A, B
*FM (message 895) 1.03 0.18 A, B
*FM (message 894) 1.03 0.18 A, B
*FM (message 873) 1.03 0.18 A, B
05 S165 0.97 -0.04 A
S95 1.03 0.03 A, B
C95 1.03 0.18 A, B
C35 1.13 0.05 A, B
*FM (message 897) 1.03 0.18 A, B
*FM (message 895) 1.03 0.18 A, B
*FM (message 894) 1.03 0.18 A, B
*FM (message 873) 1.03 0.18 A, B
00 BASIC S195 0.97 -0.04 A
S95 1.03 0.03 A, B
C95 1.03 0.18 A, B
C35 1.13 0.05 A, B
*FM = FLEXMODE
2-20
Stability criteria The following stability criteria must be met to obtain a stable electrode response
during calibration:
I(Cal 1,upd.30) I(Cal 1, upd.21) 9 Islope 0 B B
Sd,zero < Sd,max

B B B B
9.5
= 50
I(Cal 1, upd.1) I(Cal 1, upd.11)
log
All of the three criteria must be fulfilled for a calibration using Cal 1 solution
where:
I(Cal 1,upd.30) = electrode current at the 30th/21st/11th/1st updating during

P P P P P P P P
measurement on Cal 1 solution, respectively

I(Cal 1,upd.21)
I(Cal 1,upd.11)
I(Cal 1,upd.1)
Sd,zero
B B = spreading of the zero point current updatings around the
regression line
Sd,max
B B = if Sens > 400 pA/mM, then S d, max = 0.025 Sens,
otherwise S d, max = 10.0
= Should be less than or equal to 50,

and
log
should be negative or equal zero.
during measurement:
Sd,zero < Sd,max

B B B B
where:
Sd,zero
B B = spreading of the zero point current updatings around the
regression line
Sd,max
B B = if Sens > 400 pA/mM, then Sd,max = 0.025 Sens, B B B
otherwise Sd,max = 10.0

B B B
2-21
Stability criteria The (glucose or lactate) in the sample is cX(sample,corr).

(continued)
If the corrected concentration of the metabolite, cX(sample,corr) > 1, the following
criteria must be fulfilled:
I(sample, upd.30) I(sample, upd.21) 9 I slope

0 0.20
I(sample, upd.30) I 0 ( zero)
otherwise
I(sample, upd.30) I(sample, upd.21) 9 I slope

0.14
Sens
where:
I(sample,upd.30) = electrode current at the 30th/21st updating during

measurement on sample, respectively
I(sample,upd.21)
I0(zero)
B B = zero current extrapolated to the time of the measurement
If all the criteria below are fulfilled, then the result of the measurement will be
marked with an interference error.
I(sample, upd.30) - I(sample, upd.23)
1
I(sample, upd.16 - I(sample, upd.9)
I(sample,upd.16) > I(sample,upd.12)
I(sample,upd.12) > I(sample,upd.9)
cX(sample,corr)> 1.5 mmol/L
where:
I(sample,upd.30) = electrode current at the 30th/23rd/16th/12th/9th

I(sample,upd.23) B updating during measurement on sample,
I(sample,upd.16)
B B respectively
I(sample,upd.12)
B
I(sample,upd.9)
cX(sample,corr) = corrected concentration of glucose or lactate in
the sample
2-22
Crea electrodes
Introduction Blood contains both creatinine and creatine. In order to measure creatinine, a two-
electrode system is used where one electrode (E8089) measures both substances,
and the other electrode (E8088) measures creatine only.
The measurement of creatinine is done by subtracting the signals from the two
electrodes and by compensating for any interferences in the blood sample. The
compensation requires that the electrode jackets have equal properties. To ensure
this, the electrode jackets are packed in pairs in the membrane boxes and the
electrodes may only be remembraned, using a pair of electrode jackets from the
same membrane box.
Description Both electrodes: Crea A, E8088 (brown with text in ivory), and Crea B, E8089
(ivory with text in brown), have a similar construction: each consists of a silver
cathode and a platinum anode. The electrode is protected by an electrode jacket
filled with electrolyte solution and a multilayer membrane mounted at the tip.
Electrode contact
Electrode jacket
Electrolyte
AgCl reference band
Multilayer membrane
The membrane consists of three layers:

1. Outer membrane layer permeable to creatinine and creatine.
2. Middle enzyme layer.
3. Inner membrane layer permeable to H2O2. B B B B
A polarization voltage of 675 mV is applied to the electrode chain; the current

through the chain is measured by an ammeter.
2-23
Crea electrodes, Continued T T
Description Creatinine and creatine molecules are transported across the outer layer of the
(continued) multilayer membranes.
The enzymes creatininase (Crea B, E8089 electrode), creatinase and sarcosine
oxidase (Crea A, E8088 electrode) immobilized between the inner and outer
membrane layers change creatinine/creatine as follows:
Creatinine + H2O creatine (creatinine

amidohydrolase [1])
B B
creatine + H2O sarcosine + urea (creatine

amidohydrolase)
B B
Sarcosine + H2O + O2 glycine + formaldehyde + H2O2

B B B B B B B B
(Sarcosin oxidase)
The Crea B electrode (E8089) contains all three enzymes and detects both
creatinine and creatine (solid line). The Crea A electrode (E8088) contains only the
last two enzymes in the cascade and detects only creatine (dotted line).
O2 for these reactions is supplied through the outer membrane layer and also by the
B B
oxidation of H2O2 at the Pt anode.

B B B B
The H2O2 produced by the enzyme reaction is transported across the inner
B B B B
membrane to the Pt anode.
H2O2 2H+ + O2 + 2e
B B B B P P B B P P
When a potential is applied to the electrode

chain, the oxidation of H2O2 produces an B B B B
electrical current proportional to the

amount of H2O2, which in turn is directly B B B B
related to the amount of creatinine and

creatine for the Crea B and the amount of
creatine for the Crea A electrodes.
To complete the electrical circuit a
reduction reaction (where electrons are
consumed) at the cathode converts Ag+ P P
(from AgCl) to Ag:

Ag+ + e Ag P P P P
In order to maintain a charge balance between the anode and the cathode, two Ag+ P P
ions are reduced for each molecule of H2O2, which is oxidized. B B B B
2-24
Calibration S1827 Calibration Solution 1 contains creatinine and is used for calibration of the
material Crea B electrode.
S1837 Calibration Solution 2 contains creatine and is used for calibration of the
Crea A and Crea B electrodes.
The precise start concentrations are contained in the barcodes of the S1827 and
S1837 Calibration Solutions that are scanned before the calibrating solutions are
installed on the analyzer.
Zero current The zero current (I0) is a small background current measured without presence of
B B
creatinine and creatine (i.e. Rinse Solution). Immediately before the electrode
calibration or sample measurement, the measuring chamber is flushed with Rinse
solution. The zero current is therefore obtained from continuous updatings during
this period. The baseline is then extrapolated (Slope 0) throughout the
measurement period for the calibration of the signal, originating from creatinine
and/or creatine in the calibration solution or sample.
Zero current Measurement
Slope 1
Slope 0
Slope 2
Electrode updatings
The following areas of the baseline (before measurement) are used:

Slope 1 = the slope of the baseline between updatings 33 to 57
Slope 2 = the slope of the baseline between updatings 21 to 45
Slope 0 is calculated, using Slope 1 and Slope 2.
Slope 0 depends on the calculated Slope 1 as follows:
For Slope 1 > 0.5, Slope 0 = (1+koh) Slope 1 koh Slope 2 B B B B
For 0.5 Slope 1 -0.5, Slope 0 = 0

For Slope 1 < -0.5, Slope 0 = (1+koh) Slope 1 koh Slope 2 B B B B
koh is an experimentally determined constant that equals 0.5

B B
Zero current for data point n, I0(n), is then determined, using the following
B B
equation:
I0(n) = I0(47;57)median + Slope 0 (38 - n)
B B B B B B
where
I0 (47;57)median = median of the zero current between updatings 47 to 57
B B B B
The zero current of the creatinine electrodes should be less than 10.000 pA.
2-25
Sensitivity During calibration the sensitivities of Crea A and Crea B electrodes are calculated.
For creatinine and creatine the following spontaneous reaction occurs in aqueous
solution:
creatinine + H2O creatine. B B
It means that the nominal concentrations of creatinine and creatine in the

calibration solutions vary with time and temperature. The analyzer automatically
calculates the actual concentrations from the time the calibration solutions are
installed and from the ambient temperature (can be specified by the user). Before
the calibration solutions are installed on the analyzer, the substrates are added to
ensure that the nominal start concentrations are known.
During a 2-point calibration the sensitivities are calculated as follows:
The Crea B electrode is calibrated, using both calibration solutions.
IB(Cal1) I0,B(Cal1) = SensB,Creatinine cCreatinine(Cal1) +SensB,creatine
B B B B B B B B
cCreatine(Cal1)
IB(Cal2) I0,B(Cal2) = SensB,Creatinine cCreatinine(Cal2) + SensB,Creatine
B B B B B B B B
cCreatine(Cal2)
where
IB(Cal1)
B B = the Crea B electrode signal obtained on
Calibration Solution 1
I0,B(Cal1)
B B = zero current of Crea B for measurement on
Calibration solution 1
IB(Cal2)
B B the Crea B electrode signal obtained on
I0,B(Cal2)
B B = zero current of Crea B for measurement on
cCreatine (Cal1) = actual concentration of creatine (mol/L) in
cCreatinine (Cal1) = actual concentration of creatinine (mol/L) in
cCreatine(Cal2) = actual concentration of creatine (mol/L) in
cCreatinine(Cal2) = actual concentration of creatinine (mol/L) in
SensB,Creatinine B B = sensitivity of the Crea B electrode to creatinine
(pA(mM))
SensB,Creatine B B = sensitivity of the Crea B electrode to creatine
(pA(mM))
2-26
Sensitivity For the Crea A electrode (calibrated on Calibration Solution 2):

(continued)
IA(Cal2) I0,A(Cal2) = SensA,Creatine cCreatine(Cal2)
B B B B B B
where
IA(Cal2)
B B = the Crea A electrode signal obtained on
I0,A(Cal2)
B B = zero current of the Crea A for measurement on
cCreatine (Cal2) = actual concentration of creatine (mol/L) in
SensA,Creatine B B = sensitivity of the Crea A electrode to creatine
(pA(mM))
Sensitivity of the electrodes is determined from their signals corrected for their
zero currents as follows:
(1):
[I (Cal1) I 0, B (Cal1)] cCreatine(Cal2) [I B (Cal2) I 0, B (Cal2)] cCreatine(Cal1)
Sens B, Creatinine =
B
cCreatinine(Cal 1) cCreatine(Cal 2) cCreatinine(Cal 2) cCreatine(Cal 1)
(2):
[I (Cal2) I 0, B (Cal2)] cCreatinine(Cal1) [I B (Cal1) - I 0, B (Cal1)] cCreatinine(Cal2)
Sens B, Creatine =
B
cCreatinine(Cal 1) cCreatine(Cal 2) cCreatinine(Cal 2) cCreatine(Cal 1)
(3):
I A (Cal2) I 0, A (Cal2)
Sens A, Creatine =
cCreatine(Cal 2)
During the 1-point calibration only SensB,creatinine is determined. The sensitivity

B B
cannot be determined directly from equation (1). The following equation, which
uses the sensitivities determined during the previous 2-point calibration (Cal2,
prev), is then used:
(4):
[I (Cal1) I 0, B (Cal1)]
Sens B, Creatinine =
B
Sens B, Creatine (Cal2, prev)

cCreatinine(Cal 1) + cCreatine(Cal 1)
Sens B, Creatinine (Cal2, prev)
2-27
Sensitivity limits The following sensitivity limits are used:
Electrode Sensitivity Definition Limits

Crea B Sens 1 SensB,Creatinine
B B
5-15 pA/M
Sens 2 Sens B,Creatine 65-85 %
100%
Sens B,Creatinine
Crea A Sens 3 Sens A,Creatine 50-200 %
100%
Sens B,Creatinine
Sens A SensA,Creatinine
B B
3,5-20 pA/M
Additional S1827 Calibration Solution 1 does not contain creatine. So if the Crea A electrode
checks during measures creatine during calibration on the Calibration Solution 1, the reason may
calibration be that:
electrodes were placed in the wrong chambers in the Met II module
calibration solutions were interchanged
calibration solutions were not stored as instructed, and some creatinine in the
Calibration Solution 1 has been converted to creatine
During each calibration, the performance of the Crea A and Crea B electrodes are
tested. If performance of either of the electrodes is not satisfactory it will be
indicated.
Drift The drift in the sensitivity of the Crea A and Crea B electrodes are calculated from
the following equations:
(5):
[I B
(Cal1, t) I 0, B (Cal1, t)] Sens B, Creatine (t 1) cCreatine(Cal1, t)
Drift B, Creatine =
Sens B, Creatinine (t 1)
cCreatinine(Cal1, t)
The nominal creatine concentration in the Calibration Solution 1 is used in
equation (5).
Drift in the creatine sensitivity of the Crea B electrode is determined only during
the 2-point calibration:
(6):
[I B
(Cal2, t) I 0, B (Cal2, t)] Sens B, Creatinine (t 1) cCreatinine(Cal2, t)
Drift B, Creatine =
Sens B, Creatine (t 1)
cCreatine(Cal2, t)
The nominal creatinine concentration in the Calibration Solution 2 is used in
equation (6).
2-28
Drift (continued) Drift in the creatine sensitivity of the Crea A electrode is determined only during
the 2-point calibration:
(7):
[I A
(Cal2, t) I 0, A (Cal2, t)] Sens A,Creatinine (t 1) cCreatinine(Cal2, t)
Drift A,Creatine =
Sens A,Creatine (t 1)
cCreatine(Cal2, t)
The default drift tolerances set by Radiometer are:
Electrode Drift tolerances
Crea B 15 M creatinine in Calibration Solution 1
15 M creatine in Calibration Solution 2
Crea A 15 M creatine in Calibration Solution 2
Measurements The concentration of creatine in the sample is determined from the electrode
and corrections response on the Crea A electrode as follows:
I A (sample) I 0, A
(8): cCreatine (sample) =
Sens A, Creatine
uncorr
Since the carry-over from the Rinse Solution for creatine is the same for the Crea
A and Crea B electrodes, the uncorrected creatine concentration from equation 8 is
then used to obtain the creatinine concentration in the sample:
(9): cCreatinineuncorr (sample) = (IB (sample) I0, B ) Sens B,Creatine cCreatineuncorr (sample)
Sens B,Creatinine
2-29
Measurements Then the measured creatinine concentration is corrected for carry-over from the
and corrections Rinse Solution as follows:
(continued)
Equation A:
cCrea(sample,corr) macromode = A0,macromode cCreatinineuncorr(sample) + A1,macromode
B B B B B B B B
Equation B:
cCrea(sample,corr)micromode = A0,micromode cCrea(sample)macromode + A1,micromode
B B B B B B B B
where:
cCrea(sample,corr) = corrected measured creatinine concentration from a sample
cCreatinineuncorr(sample) = uncorrected measured creatinine concentration from a
B B
sample
A0 = instrument-dependent correction factor
B B
A1 = instrument-dependent cut-off
B B
Analyzer Mode A0B B A1

B B Equation
37/27/17 S250 1.0262 0.4211 A
C125 1.0262 0.4211 A
*FM (message 903) 1.0819 -3.8515 A, B
*FM (message 902) 1.0819 -3.8515 A, B
*FM (message 901) 1.0819 -3.8515 A, B
*FM (message 900) 1.0819 -3.8515 A, B
*FM (message 899) 1.0819 -3.8515 A, B
*FM (message 898) 1.0819 -3.8515 A, B
*FM = FLEXMODE
Whole blood The ABL8x7 FLEX analyzers are designed to measure cCrea on whole blood. If
correction plasma, serum or NIST SRM is to be measured on the ABL8x7 FLEX analyzers,
cCrea must be corrected as follows:
cCrea(sample,corr) (ABL8x7,plasma/serum) mol/L = 0.950 cCrea(ABL8x7,whole blood) 0.4

cCrea(sample,corr) (ABL8x7,plasma/serum) mg/dL = 0.950 cCrea(ABL8x7,whole blood) 0.005
where
cCrea(ABL8x7,whole blood) is the result obtained on the analyzer.
2-30
References
List of 1. Yamamoto K, Oka M, Kikuchi T, Emi S. Cloning of the creatinine

references amidohydrolase gene from Pseudomonas sp. PS-7; Biosci Biotechnol
Biochem 1995;59:1331-32
2-31
2-32
3. Optical measuring principles
Overview
Introduction This chapter describes the optical system, its construction and the measuring
method used.

Optical system.................................................................................................. 3-2
X X
Correcting for interferences ............................................................................. 3-7

X X
Measurement and corrections .......................................................................... 3-9

X X
References ........................................................................................................ 3-15

X X
3. Optical measuring principles ABL800 FLEX reference manual
Optical system
Measured The optical system of the ABL800 FLEX analyzer is designed to measure the
parameters following parameters:
Parameter Description
ctHb
T T Concentration of total hemoglobin
sO2 B B Oxygen saturation
FO2Hb B B Fraction of oxyhemoglobin
FCOHb Fraction of carboxyhemoglobin
FHHb Fraction of deoxyhemoglobin
FMetHb Fraction of methemoglobin
FHbF Fraction of fetal hemoglobin
ctBil
T T Concentration of total bilirubin (the sum of unconjugated
and conjugated bilirubin) in plasma
NOTE: ctBil can be measured on a whole-blood or plasma sample. Plasma

T T T T
samples provide the optimal measurement performance. To obtain optimal

accuracy when following a patient trend in ctBil, use the same aspiration mode T T
and the same analyzer.

Hematocrit (Hct) is also available as a derived parameter.
T T T T
Construction The optical system is based on a 128-wavelength spectrophotometer with a

measuring range of 478-672 nm. The spectrophotometer is connected via an
optical fiber to a combined hemolyzer and measuring chamber.
Spectrophotometer
Photodiode array
Concave grating
Slit
Optical fiber
Sample out
Hemolyzer Cuvette
Lamp unit
Infrared filter
Lens
Sample in
3-2
ABL800 FLEX reference manual 3. Optical measuring principles
Optical system, Continued T T
Construction The method used in the analyzer's optical system is visible absorption
(continued)
T spectroscopy.
Step Description
1
T T The blood sample is transported to the cuvette positioned in the
hemolyzer unit. The temperature of the cuvette is regulated to 37 oC.
P P
2
T T
1 L of the sample is ultrasonically hemolyzed in the cuvette at a
frequency of about 30 kHz in order to rupture the walls of the red
blood cells so that their content is mixed with the blood plasma,
giving an optically clear solution. There is no bilirubin in the red
blood cells, so after hemolyzation the red blood cell intracellular fluid
dilutes the plasma bilirubin. The calculation discussed in
Measurement and Corrections corrects for this dilution.
T T
To eliminate air bubbles in the sample and to enhance hemolyzation, an

overpressure of one atmosphere is maintained throughout hemolyzation
and measurement.
3
T T Light from a 4-Watt halogen lamp is sent to the cuvette via an infra-
red filter and a biconvex lens.
The voltage across the halogen lamp is regulated by a thermostatted
photodiode so that the amount of light sent to the cuvette has a constant
intensity.
4
T T The light transmitted through the cuvette is guided to the
spectrophotometer via an optical fiber.
5
T T The light passes through a slit that directs it towards a combined
mirror and concave grating.
6
T T The grating separates the light into 128 single wavelengths and the
mirror focuses the 128 light signals on a photodiode array.
7
T T The photodiode array has 128 diodes or pixels, one for each
wavelength, which convert the monochromatic light signals to
currents.
8
T T The currents and therefore the intensity of the light signals are
measured at each of the 128 diodes, which form the basis for the
absorption spectrum for a particular sample.
9
T T The spectrum is sent to the analyzers computer, where the
calculations of the oximetry parameter values are made.
3-3
Lambert-Beers Absorption spectroscopy is based on Lambert-Beer's law which states that the
law 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]:
Ay = y cy l
where:
Ay = absorbance of compound y at wavelength
y = extinction coefficient of compound y at wavelength (a constant,

characteristic of the compound)
cy = concentration of compound y in sample
T l T = length of the light path
Absorbance The absorbance (A) of a compound is defined as the logarithm of the ratio of the
light intensity before and after transmission through the compound.
In practice it is the logarithm of the ratio of the light intensity transmitted through
water to the light intensity transmitted through the compound.
I0
A = log
I
where:
I0 = intensity of light transmitted through water (I0 is measured as the T B TB
intensity of light transmitted through the Cal 1 or Cal 2 solutions)

I = intensity of light transmitted through the compound
Total For samples containing more than one optically active compound, the total
absorbance absorbance (Atotal) is the sum of the individual compounds absorbance, since
B B
absorbance is an additive quantity.

For example, if a sample contains six compounds y1, y2, .y6, the total absorbance B B B B B B
measured for that sample at wavelength 1 is: B B

Atotal
1
= Ay + Ay + Ay + Ay + Ay + Ay 1
1
1
1
2
1
3 4
1 1
5 6
(
= l y c y + y c y + y c y + y c y + y c y + y c y
1
1 1
1
2 2 3
1
3
1
4 4
1
5 5
1
6 6
)
If there are Y compounds and measurements are taken at n wavelengths, a general T T
expression can be written for Atotal at the wavelength n: T TB B B B
Y

Atotal = y cy l
n n
y =1
where:
n = the individual wavelengths.
B B
3-4
n
Continuous Atotal can be depicted graphically as a function of wavelength, and if the
spectrum
differences between the wavelengths are small enough, a continuous spectrum is
produced.
EXAMPLES:
T
The figure below shows three spectra; pure O2Hb, pure HHb in a low B B
concentration, a spectrum of 92 % oxygenated hemoglobin obtained by adding the

spectra of O2Hb and HHb. The additivity of absorption and the continuity of the
B B
spectra can clearly be seen.
Absorption
480 500 520 540 560 580 600 620 640 660 680
Wavelength/nm
O2Hb (9.2 mmol/L)
HHb (0.8 mmol/L)
92 % oxygenated hemoglobin (i.e., 92 % O2Hb + 8 % HHb)
Example of the spectrum obtained from unconjugated bilirubin at concentration of

200 mol/L.
200um o l/L U ncon jugated B ilirubin in P lasm a
0.1
0.08
Absorba nce
0.06
0.04
0.02
0
470 520 570 620 670
nm
The spectrum of conjugated bilirubin is slightly different.
3-5
Determining In the spectrum taken of a sample, the absorption recorded at each wavelength
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.
The concentrations are determined using the following equation:
128
cy = K y Atotal
n n
n =1
where:
K y
n
= a constant specific to compound y at wavelength n. B B
Matrix of The constants ( K y n ) are determined using Multivariate Data Analysis [2] where
constants
the spectra of the calibration compounds were considered together with the
reference values of the calibration compounds. The essential interfering substances
were also taken into account.
3-6
Correcting for interferences
HbF versus Fetal hemoglobin (HbF) does not have the same spectrum as adult hemoglobin
HbA (HbA) due to a slight variation in molecular structure. The presence of HbF in a
sample will interfere with the result if it is not corrected for.
It is thus important when measuring hemoglobin levels in premature neonates and
neonates aged 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.
NOTE: Hb types other than HbA and HbF interfere with haemoglobin
T T
measurements and are not compensated for in the ABL800 FLEX analyzers.
The diagram below shows the transition from fetal hemoglobin to adult
hemoglobin [4].
This graph is only schematic and cannot be used to determine FHbF. T T
Deviation of If the difference between the two types of hemoglobin is not accounted for in
results measurements on samples containing HbF, e.g. from premature neonates and
neonates aged 0 to 3 months, then a deviation in the measurement will arise.
The deviation is most important for measurements of oxygen saturation (sO2) and B B
the fraction of carboxyhemoglobin (FCOHb), since inaccurate measurements of

these parameters can lead to incorrect diagnostic interpretation of the results, and
consequent risk of inappropriate treatment.
Detecting HbF The presence of HbF in a sample is detected from the difference spectrum between
fetal and adult oxyhemoglobin. From the size of the difference spectrum the
concentration of fetal oxyhemoglobin, cO2HbF, can be measured.
T T B B
Correcting for The amount of cO2HbF exceeding a certain level indicates HbF interference. The
T T B B
HbF analyzer automatically corrects for this interference by subtracting the difference
spectrum of fetal oxyhemoglobin from the measured spectrum. It then makes
further calculations, using cO2HbF to measure FHbF.
T T B B T T
3-7
Correcting for interferences, Continued T T
Most likely Fetal hemoglobin and non-hemoglobin substances present in blood that absorb
interfering light within the same wavelength range used to measure the oximetry parameters
substances and bilirubin, will interfere with the true spectra of the blood samples.
The optical system in the ABL800 FLEX analyzers compensates for the most
likely interfering substances by repressing their spectra.
The interference from the following substances the analyzer compensates for when
measuring the oximetry parameters:
Intralipids (turbidity)
Sulfhemoglobin, SHb
Repressing Repressing the spectra of the likely interfering substances is done in two ways
spectra depending on the substance:
Either the substance is taken account of in the calculation of the matrix of
T T
constants, K (see the section Measuring Principle in this chapter). This applies
T T
to Intralipids and Sulfhemoglobin,

Or the substance is detected, and the measured spectrum is corrected
T T
accordingly. This applies to HbF.
Residual A measured spectrum is compared to a model spectrum calculated from the

spectrum determined concentrations. The difference between the two spectra is then called
the residual spectrum. If the difference is too high, a warning (Oxi spectrum
mismatch) is issued on all the oximetry module parameters ctHb, sO2, FO2Hb, B B B B
FCOHb, FMetHb, FHHb, FHbF and ctBil. T T
The same action is taken if one of the following conditions exists and FHbderiv is B B
defined as one of the parameters sO2, FO2Hb, FCOHb, FMetHb, FHHb:

B B
ctHb<0.1 mmol/L or ctHb>25 mmol/L.

FHb(deriv)<2% or FHb(deriv)>102%.
Negative fraction of SHb<2% is detected.
Value of Turbidity<0.5%.
3-8
Measurement and corrections
Oximetry The oximetry parameters are calculated as follows:

parameters
Parameter Equation
ctHb(meas) = cO2Hb + cCOHb + cHHb + cMetHb
B B
cO 2 Hb
sO2 =
B B
ceHb
ceHb = cHHb + cO2Hb (effective hemoglobin)
T T T T T T B B
cO 2 Hb
FO2Hb =
B B
ctHb
cCOHb
FCOHb =
ctHb
cHHb
FHHb =
ctHb
cMetHb
FMetHb =
ctHb
FHbF cHbF
=
ctHb
where:
cO2Hb B B = concentration of oxyhemoglobin in the sample
cCOHb = concentration of carboxyhemoglobin in the sample
cHHb = concentration of deoxyhemoglobin in the sample
cMetHb = concentration of methemoglobin in the sample
cHbF
T T = concentration of fetal hemoglobin in the sample
Bilirubin Bilirubin is calculated as follows:

ctBil(B)
ctBil(P) =
1 Hct(calc)
where:
ctBil(P) = concentration of total bilirubin in plasma
ctBil(B) = concentration of diluted plasma bilirubin after sample
hemolyzation
Hct(calc) = calculated hematocrit (a fraction).
3-9
Measurement and corrections, Continued T T
Bilirubin 0.0301
Hct(calc) = ctHb
T
(continued) T
g / dL
For further details on Hct(calc) please refer to Interference Tests and the
T T
explanation of MCHC (Mean Corpuscular Hemoglobin Concentration) in chapter

5 in this manual.
T T
Restrictions The following parameters will not be calculated:

Parameter Is not calculated if
sO2, FCOHb, FMetHb, ceHb = cHHb + cO2Hb < 0.75 mmol/L;
B B T T B B
FHHb
ctHb < 1 mmol/L
ctBil
T T ctHb > 15.5 mmol/L
The following conditions are required to exclude HbF interference:
Parameter or Feature Requirement

ceHb
T T > 3 mmol/L
FCOHb < 15 %
FMetHb < 10 %
"HbF correction" has not If ctHb < 5 mmol/L, cO2HbF should be more than 1 T T B B
been activated mmol/L.

If ctHb > 5 mmol/L, cO2HbF/ctHb should be more
T T B B
than 0.2.
"HbF correction" has No lower limit value for cO2HbF is required, i.e. T T B B
been activated even adult blood samples will be corrected for HbF.
It may be of value when analyzing blood samples
from newborns who received adult blood transfusion.
In these cases FHbF can be lower than 20 % and
significant deviations of oximetry parameters and
bilirubin can occur.
HbF suppression has The FHbF value is displayed by the ABL835/30
been activated FLEX analyzers.
Message HbF detected is displayed on the other
analyzer versions with the oximetry module
installed.
sO2 < 50 % or B B Message FHbF measurement is not possible is
displayed by the ABL835/30 FLEX analyzers if a
ctHb < 5 mmol/L
HbF suppression has been activated.
3-10
Corrections for The uncorrected hemoglobin concentration, ctHb(sample), measured on capillary

ctHb or syringe samples is corrected as follows:
Equation A:
T
ctHb(sample)
ctHb(sample, corr) =
Fcuv Fdil
where:
ctHb(sample,corr) = corrected ctHb
FcuvB B = analyzer-dependent constant determined at tHb
calibrations and automatically stored by the analyzer
FdilB B = analyzer-dependent constant determined during tests
against the reference method, which corrects for Hb
dilution in the different aspiration modes.
ABL8xx
T T Mode T Fdil
T B TB T EquationT
FLEX T
37/27/17 S250 1.0000 A

C125 1.0110 A
*FM (message 903) 0.9714 A
*FM (message 902) 0.9714 A
*FM (message 901) 0.9714 A
*FM (message 900) 0.9714 A
*FM (message 899) 0.9714 A
*FM (message 898) 0.9714 A
*FM = FLEXMODE
3-11
Corrections for
ctHb (continued)
T T T
ABL8xx Mode Fdil Equation
FLEX
35/25/15 S195 1.0000 A
S95 0.9630 A
S85 1.0050 A
C95 0.9630 A
C55 0.9220 A
C35OXI 0.9570 A
*FM (no message) 1.0110 A
*FM (message 897) 0.9630 A
*FM (message 895) 0.9630 A
*FM (message 894) 0.9630 A
*FM (message 873) 0.9630 A
*FM (message 872) 0.9490 A
*FM (message 871) 0.9440 A
*FM (message 870) 0.9230 A
*FM (message 869) 0.9230 A
30/20/10 S85 1.0050 A
10 BG only C55 0.9220 A
FLEX C35 OXI 0.9570 A
*FM (message 872) 0.9490 A
*FM (message 871) 0.9440 A
*FM (message 870) 0.9230 A
*FM (message 869) 0.9230 A
00 BASIC S195 1.0000 A
S95 0.9630 A
S85 1.0050 A
C95 0.9630 A
C35OXI 0.9570 A
*FM = FLEXMODE
3-12
Corrections for The uncorrected total bilirubin concentration, ctBil(sample), measured on capillary
ctBil
T T
or syringe samples is corrected as follows:
Equation A:
T
ctBil(sample)
ctBil(sample, corr) =
Fcuv Fdil
where:
ctBil(sample,corr) = corrected ctBil
Fcuv
B B = analyzer-dependent constant determined at tHb
calibrations and automatically stored by the analyzer
Fdil B B = analyzer-dependent constant determined during tests
against the reference method, which corrects for ctBil T T
dilution in the different aspiration modes.
ABL8xx
T T Mode
T T T Fdil
B TB Equation
T T
37 S250 1.0050 A
C125 0.9900 A
*FM (message 903) 0.9432 A
*FM (message 902) 0.9432 A
*FM (message 901) 0.9432 A
*FM (message 900) 0.9432 A
*FM (message 899) 0.9432 A
*FM (message 898) 0.9432 A
*FM = FLEXMODE
3-13
Corrections for
ctBil (continued)
T T T
ABL8xx Mode Fdil Equation
35 S195 1.0050 A
S95 0.9320 A
S85 1.0000 A
C95 0.9320 A
C55 0.8640 A
C35 OXI 0.9160 A
*FM (message 897) N/A
30 S85 1.0000 A
C55 0.8640 A
C35 OXI 0.9160 A
*FM = FLEXMODE
3-14
References
List of The list of the references for chapter 3, The Optical Measuring Principles:
T T
references
1. Ewing GW. Instrumental methods of chemical analysis. 5th ed. McGraw-Hill,
1985.
2. Martens H. Multivariate calibration: quantitative interpretation of non-selective
chemical data. Dr. Techn. Thesis, NTH Univ. of Trondheim, 1986.
3. Krzeminski A. Why correct for fetal hemoglobin in blood oximetry
measurements? Radiometer Publication Info. No. 1992-3. Copenhagen:
Radiometer Medical A/S, 1992.
4. Huehns ER, Beaven GH. Developmental changes in human hemoglobins. Clin
Dev Med 1971; 37: 175-203.
3-15
3-16
4. User-defined corrections
Overview
Introduction This chapter describes the basis of the user-defined corrections available for all the
measured parameters.

X X
Correction factors for oximetry parameters and bilirubin................................ 4-4

X X
Electrolyte and metabolite parameters ............................................................. 4-7

X X
4-1
4. User-defined corrections ABL800 FLEX reference manual
General information
Purpose of use User-defined corrections are most commonly implemented in situations where the
values measured for a particular parameter by two or more analyzers, deviate
consistently from each other.
NOTE:
T T Since the performance of all analyzers is tested as described in chapter
5, Performance Characteristics, and each instrument is assumed to
operate accurately and optimally, the unnecessary correction of
parameter values by the user can lead to inaccurate measurements
being reported.
User-defined User-defined corrections are based on a linear correlation between the measured
corrections values (without user-defined corrections) and the displayed values (with user-
defined corrections).
The correction factors for each measured parameter are the slope and the offset of
the correction line. With user-defined corrections it is possible to change the values
of either one or both of these correction factors, depending on the parameter type.
Corrected value = Slope Uncorrected value + Offset

The diagram below is a schematic representation of the relationship between
correction lines without and with user-defined correction.
Correction line without

user correction
Displayed (corrected)
parameter value
Correction line with
user correction
Slope = 1
Offset
Measured
(uncorrected)
0.0 parameter value
4-2
ABL800 FLEX reference manual 4. User-defined corrections
Entering The slope/offset for each parameter are configured in the General Setup >
user-defined Parameters 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" option was
deactivated in Miscellaneous Setup.
For detailed instructions on how to enter user-defined corrections, refer to the
section Parameter Setup in chapter 3 of the Operators Manual.
T T T T T T
4-3
Correction factors for oximetry parameters and bilirubin
Allowed The following corrections can be user-defined for the oximetry parameters and
corrections bilirubin:
Parameter Allowed user-defined corrections

Slope
T T Offset
T T
ctHb
T T T Yes No
sO2
T T B TB Yes Yes
FCOHb
T T T No Yes
FMetHb
T T T No Yes
FO2Hb
T T B B T No No
FHHb
T T T No No
FHbF
T T Yes Yes
ctBil
T T T Yes Yes
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.
ctHb The following recommendations apply to ctHb:
Item Description
Units g/dL; g/L; mmol/L
Sample Set ctHb of a SAT100 sample to 15 g/dL (9.3 mmol/L) and
T T
pH 7.4
ctHb, maximum Uncorrected or corrected: 15 g/dL or 9.3 mmol/L
point
Slope 0.950-1.050
sO2
B B The following recommendations apply to sO2 : B B
Item Description
Units Fraction
Sample Set ctHb of gas equilibrated SAT0 and SAT100 samples to
T T
15 g/dL (9.3 mmol/L) and pH 7.4

Slope 0.900-1.100
Offset 0.050
4-4
Correction factors for oximetry parameters and bilirubin,

Continued
T T
FCOHb The following recommendations apply to FCOHb:

Item Description
Units Fraction
Sample The zero point (FCOHb 0) is saturated to approximately
T T
SAT100, and ctHb is set to 15 g/dL (9.3 mmol/L) and pH

T T
7.4.
Offset 0.050
FMetHb The following recommendations apply to FMetHb:

Item Description
Units Fraction
Sample The zero point (FMetHb 0) is saturated to approximately
T T
SAT100, and ctHb is set to 15 g/dL (9.3 mmol/L) and pH

T T
7.4.
Offset 0.050
FHbF The following recommendations apply to FHbF:

Item Description
Units Fraction
Sample Radiometer recommends that ctHb in the adult samples (with
T T
FHbF = 0) and fetal samples (with high FHbF) is set to 15

g/dL (9.3 mmol/L), sO2 100 % and pH 7.4.
B B
The Correction for HbF levels less than 20 % function

should be enabled in order to have the FHbF value displayed
for the adult sample.
Averaging repeated measurements on blood from different
donors gives an optimized accuracy of the correction.
Averaging repeated measurements on blood from the same
donor also improves the accuracy.
Slope 0.800-1.200
Offset 0.20
4-5
Correction factors for oximetry parameters and bilirubin,

Continued
T
ctBil
T T The following recommendations apply to ctBil:
Item Description
Units mol/L
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 mol/L) and maximum point could
be an unconjugated bilirubin sample with ctBil 300-400 T T
mol/L.
Averaging repeated measurements on samples from different
donors gives an optimized accuracy of the correction.
Averaging repeated measurements on samples from the same
donor also improves the accuracy.
Commercial bilirubin standards can interfere with bilirubin
measurement because they may have an absorbance spectrum
different from that of human plasma.
Slope 0.5-1.5
Offset 100
FO2Hb and
B B
The units for FO2Hb and FHHb are [Fraction]. T T B B T T
FHHb
After the user-defined corrections of the parameters sO2, FCOHb and FMetHb T T B B T T T T
have been carried out, FO2Hb and FHHb are automatically calculated using the B B T T
formulae stated below, since the sum of the fractions FCOHb, FMetHb, FO2Hb T T T T B B
and FHHb as defined must be equal to 1.0:

T T
FO2Hb:
T B B T
FO2Hb = (1 FCOHb FMetHb) sO2

B B T T T T T T B B
FHHb:
T T T
T FHHb = (1 FCOHb FMetHb) (1 sO2)

T T T T T T T B B
4-6
Electrolyte and metabolite parameters
Preparatory Prior to entering corrections for the electrolyte and metabolite parameters, the user
actions must obtain the reference values for the chosen parameters using the method
accepted in his/her laboratory.
It should be noted that in order to define corrections:

Measurements should be taken on the analyzer without user-defined corrections,
and on the reference analyzer
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 analyzer as an independent
variable
If the measurements are carried out on samples with values within the normal
reference range, then the user may change the offset and leave the slope
unchanged
The user must verify the corrections that are entered
Details of these procedures may be found in the section Definitions and Test T
Conditions in chapter 5.
T T T
Correcting the The following corrections to the slope are possible within the stated limits:
slope
Parameter
T T T Slope (mmol/L) T
cK+
T T P P 0.750-1.250
+
cNa
T T P P 0.850-1.150
2+
cCa
T T P P 0.800-1.200

cCl
T T P P 0.850-1.150
cGlu
T T 0.750-1.250
cLac
T T 0.750-1.250
cCrea
T T 0.75-1.250
Correcting the The following corrections to the offset are possible within the stated limits:
offset
Parameter:
T T T cK+
T P P T cNa+T P P cCa2+
T T P P
T cCl
T P P cGlu
T T cLac
T T cCrea
T T
Offset
T 0.3 5 0.05 5 0.5 0.5 100 mol/L
(mmol/L): T
4-7
Electrolyte and metabolite parameters, Continued T T
Resetting The Radiometer default values for the electrolyte and metabolite parameters must
corrections to be reset manually by the user to 1.000 for each parameter on the Parameters
T
default values Setup screen.

T
4-8
5. Performance characteristics
Overview
Introduction This chapter describes performance characteristics of the ABL8x0/8x5 and

ABL8x7 FLEX analyzers for each measured parameter and test conditions to
obtain them.

Definition of terms ........................................................................................... 5-2
X X
ABL8x0/8x5 Performance characteristics ................................................... 5-5

X X
Test conditions ........................................................................................... 5-6

X X
Performance test results chart description............................................... 5-7

X X
Performance test results - pH ................................................................... 5-10 X X
Performance test results pCO2 ................................................................ 5-12

B B X X
Performance test results pO2 .................................................................. 5-15

B B X X
+
Performance test results cK ................................................................... 5-18
P P X X
+
Performance test results cNa .................................................................. 5-20
P P X X
Performance test results cCl................................................................... 5-22

P P X X
2+
Performance test results cCa ................................................................ 5-28
P P X X
Performance test results cGlu.................................................................. 5-26 X X
Performance test results cLac.................................................................. 5-28 X X
Performance test results ctHb.................................................................. 5-30 X X
Performance test results oximetry ........................................................... 5-32 X X
Performance test results bilirubin............................................................ 5-42 X X
Additional information about FLEXMODE .............................................. 5-48 X X
ABL8x7 Performance characteristics........................................................... 5-49 X X
Test conditions ........................................................................................... 5-50 X X
Performance test results pH, pCO2, pO2 ................................................. 5-51

B B B B X X
Performance test results electrolytes ....................................................... 5-54 X X
Performance test results cGlu, cLac........................................................ 5-58 X X
Performance test results ctHb.................................................................. 5-60 X X
Performance test results oximetry ........................................................... 5-61 X X
Performance test results bilirubin............................................................ 5-70 X X
Performance test conditions and results cCrea........................................ 5-72 X X
Interference tests .............................................................................................. 5-92 X X
References ........................................................................................................ 5-103

X X
5-1
5. Performance characteristics ABL800 FLEX reference manual
Definition of terms
General Performance specifications are achieved by comparison between the ABL8x0/8x5

information FLEX analyzers and the primary reference methods, and by comparison between
these analyzers and the ABL735.
Performance specifications of the ABL8x0/8x5 FLEX analyzers are described,
using the following:
BiasRef = the mean difference between the ABL8x0/8x5 FLEX analyzer and the
B B
primary reference methods.

BiasABL = the mean difference between the ABL8x0/8x5 FLEX analyzer and the
B B
ABL735 analyzer.
Repeatability
Reproducibility
Total variation range
Imprecision
Bias The bias of a quantity is defined as the mean difference between the measured
value on a group of test instruments and the estimated true value (as assayed by the
reference method). BiasRef is determined as follows:
B B
BiasRef = X ABL8x0/8x5 FLEX X Reference method

B B B B B B
BiasABL is a relative bias between the ABL835 FLEX analyzer in FLEXMODE and
B B
the ABL735 analyzer in macromode (C195 L mode), and is determined as

follows:
BiasABL = X ABL8x0/8x5 FLEX X ABL735
B B B B B
Bias given in the tables in this chapter have been obtained experimentally.
Repeatability Samples, assumed to be identical, repeatedly measured on one analyzer will not
necessarily yield identical results. The degree of variation in the results is a
measure of the repeatability of the analyzer.
The repeatability is obtained from repeated measurements within a short interval of
time using:
The same instrument and location
The same measurement procedure
Identical portions of the same sample
One operator per instrument
The repeatability for each level is pooled for all test instruments and test days.
5-2
ABL800 FLEX reference manual 5. Performance characteristics
Definition of terms, Continued T T
Reproducibility Reproducibility is obtained from repeated measurements over several days using:
Random instrument
Random sample
Random operators
Reproducibility for each level is pooled for all test instruments and test days.
Total analytical TEA, total analytical error is a quality specification that sets a limit for both the
TB TB
error random error (imprecision) and systematic error (inaccuracy) in a single

measurement or single test result. In Radiometer reference manual the following
expression for total analytical error is either expressed in an absolute number (TEA B B
= (Bias+1,65Sx)) or in % (TEA = (Bias+1,65CVx )). The formula we

B B B B B B
are using for total error allowable works at 95% probability to allow for 5% error.
Imprecision Repeated measurements using one analyzer on samples assumed to be identical

will not necessarily yield identical results. The degree of variation in the results is
a measure of the precision of the analyzer.
The following table describes the parameters used to characterize precision
obtained via the performance tests on the ABL8x0/8x5/8x7 FLEX analyzers.
Parameter Description
S0 B B Repeatability
T
This is a standard deviation obtained from repeated

measurements within a short interval of time using:
The same instrument and location
The same measurement procedure
Identical portions of the same sample
One operator per instrument
S0 for each level is pooled for all test instruments and test days.
B B
SD B B Day-to-day variation
T
This is a standard deviation obtained from repeated

measurements over all test days.
Includes contributions from differences in calibration states of the
analyzers throughout the test days.
SABL
B B Uncertainty of bias on a random instrument
T
SABL is used for repeated determinations on one sample. This

B B
standard deviation includes the inter-instrument variations,

sample variations, and uncertainties from standard solutions and
reference methods.
5-3
Definition of terms, Continued T T
Imprecision Parameter Description

(continued)
Sx
T T
B B Uncertainty of bias on a random instrument for a single

measurement
Sx is a standard deviation, which includes SABL, SD and S0.
B B B B B B B B B B
S0, SD and SABL given in the tables are Radiometer requirements. Experimental data
B B B B B B
are always lower.
Confidence Confidence interval provides a range of values estimated from a study group that is
intervalsT highly likely to include the true, but unknown, value ("confidence interval" applies
to the results of a statistical analysis). A 95 % confidence interval means that there
is only a 5 % chance that the true value is not included in the interval.
Prediction The 95 % prediction interval is much wider than the 95 % confidence interval
interval about, for example, the mean regression line response. For any given value of the
independent variable, this interval represents the 95 % probability for the values of
the dependent variable.
5-4
ABL8x0/8x5 Performance characteristics
Overview
Introduction This chapter describes performance characteristics of the ABL8x0/8x5 FLEX

analyzers for each measured parameter and test conditions to obtain them.
Contents This section contains the following topics.

Test conditions ................................................................................................. 5-6
X X
Performance test results chart description..................................................... 5-7

X X
Performance test results - pH ......................................................................... 5-10 X X
Performance test results pCO2 ...................................................................... 5-12

B B X X
Performance test results pO2 ........................................................................ 5-15

B B X X
Performance test results cK+ ......................................................................... 5-18

P P X X
+
Performance test results cNa ....................................................................... 5-20
P P X X

Performance test results cCl ......................................................................... 5-22
P P X X
Performance test results cCa2+ ...................................................................... 5-28

P P X X
Performance test results cGlu........................................................................ 5-26 X X
Performance test results cLac........................................................................ 5-28 X X
Performance test results ctHb........................................................................ 5-30 X X
Performance test results oximetry ................................................................. 5-32 X X
Performance test results bilirubin.................................................................. 5-42 X X
Additional information about FLEXMODE .................................................... 5-48 X X
5-5
Test conditions
ABL8x0/8x5 Test conditions to determine biasABL, repeatability and total variation for pH,
B B
pCO2, pO2, cCa2+, cCl, cK+, cNa+, cGlu, cLac, ctHb were as follows:
B B B B P P P P P P P P
Item Description
Reference analyzers Five ABL735 with AutoCheck module were used as a
reference. The C195 mode was used as a reference for
all measured parameters.
Primary reference As specified for each parameter further in this chapter.
methods
Analyzers and test Five ABL835, three ABL830 and three ABL805 were
modes tested over 11 days in the following modes:
Syringe: S195, S165, S95, S85
Capillary: FLEXMODE, C95, C85, C55, C35
OXI, C35 MET
Blood samples Heparinized blood samples from healthy, voluntary
donors.
Eleven blood pools were prepared to cover test ranges
for all measured parameters.
Blood measurements The measurements were performed by different
operators.
Calibration solution and All calibration solutions and gases used for the tests
gases are traceable to Primary Reference Standards.
Traceability certificates for the ABL800 FLEX
calibration solutions and gases are found at the end of
chapter 7: Solutions. T T
Experimental Ambient temperature: 22-25 C

conditions
Relative humidity: 30-50 %.
NOTES:
T
The solutions used in the performance tests are those recommended by
T
Radiometer. Performances using other solutions cannot be guaranteed.

The performance tests are performed under conditions where the analyzers are
T
not influenced by electromagnetic fields. T
5-6
Performance test results chart description
Modes Tests were performed in the following 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;
FLEXMODE ABL830 (no message)
FLEXMODE (message 869)
BiasABL chart
B B The legend of the BiasABL chart is given below:
B B
description
Chart Description
"x" axis The ABL735 mean values obtained as follows:
To determine the best possible ABL735 reference value for each
parameter of a specific sample, the measurements on five
ABL735 analyzers are plotted as a function of time. A regression
line is made to represent the best possible mean ABL735
measurement at a given time thus compensating the metabolism
of the sample during repeated measurements on it.
"y" axis Bias in %; bias for pH in pH units.
95 % statistical confidence range for bias in macromodes.
95 % statistical confidence range for bias in micromodes.
Nmacro
B B Number of measurements in macromodes.
Nmicro
B B Number of measurements in micromodes.
5-7
Performance test results chart description, Continued T T
Repeatability Repeatability is presented as a plot of the coefficient of variation (CV %).

chart Contribution to variation, such as sample matrix and environmental conditions, are
not directly included, but compensated for by extending the repeatability values
shown in the chart.
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.
Nmacro
B B Number of measurements in macromodes.
Nmicro
B B Number of measurements in micromodes.
Total variation Total variation chart is presented as a difference plot against the regression line at
chart 5 ABL735 analyzers. The individual measurements are plotted directly.
Chart Description
"x" axis The ABL735 mean values obtained as follows:
To determine the best possible ABL735 reference value for each
parameter of a specific sample, the measurements on five
ABL735 analyzers are plotted as a function of time. A regression
line is made to represent the best possible mean ABL735
measurement at a given time thus compensating the metabolism
of the sample during repeated measurements on it.
"y" axis Total variation in %; total variation for pH in pH units.
At least 95 % statistical confidence range for total variation in
macromodes.
At least 95 % statistical confidence range for total variation in
micromodes.
o Observations in macromode.
x Observation in micromode.
Nmacro
B B
Number of measurements in macromode see the next page.
Nmicro B B
Number of measurements in micromode see the next page.
5-8
Performance test results chart description, Continued T T
Number of The number of measurements in macro- and micromodes, and the total number of
measurements measurements during the test is listed below:
Parameter Nmacro
B B Nmicro
B B Total
pH 3334 421 3755
pCO2 B B 2768 397 3165
pO2 B B 282 2912 3194
+
cKP P 422 1364 1786
+
cNa P P 423 1362 1785
2+
cCa P P 407 1148 1555
cCl P P 426 1360 1786
cGlu 423 1825 2248
cLac 412 1829 2241
ctHb 415 3032 3447
5-9
Performance test results pH
Reference Capillary-type glass pH electrode with a saturated calomel reference electrode and
method a liquid junction saturated with KCl (BMS Mk2) [1,2].
The calibration standards are traceable to the Primary Reference Standards for pH.
BiasREF
B B The FLEXMODE on the ABL805/30/35 FLEX analyzers was tested:
pH Bias REF
B B N
7.0 0.002 90
7.4 0.002 90
7.7 0.002 90
N = number of measurements on several analyzers used for the test.
BiasABL blood
B B This bias is presented by the following chart:
samples
Bias (pH)
ABL735 (pH)
5-10
Performance test results pH, Continued T T
Repeatability Repeatability is presented by the following chart:
Repeatability (pH)
ABL800 FLEX
Total variation Total variation is presented by the following chart:
Total variation (pH)
ABL735
5-11
Performance test results pCO2 T T B B
Reference Tonometry [3].

method
The gases used for tonometry are traceable to NIST-certified Standard Reference
Materials.
BiasREF
pCO2 (mmHg)
B B Bias REFB B N
15 0.11 60
40 0.38 60
60 0.29 60
80 0.20 60
150 0.21 60
BiasABL blood
samples
Bias (%)
ABL735 (mmHg)
5-12
Performance test results pCO2, Continued T T B B T T
Repeatability (%)
ABL800 FLEX (mmHg)
Total variation (%)
ABL735 (mmHg)
5-13
Performance test results pCO2, Continued T T B B T T
Bias and The bias and imprecision for expired air samples are as follows*:
imprecision
expired air
samples pCO2 (mmHg)
T B B T Bias T
ABL835/30/25/20/15/10/05 T
15 0.2
40 0.2
60 0.4
80 0.2
150 1.6
pCO2
T B B S0
T B TB T SD B TB T SABLB TB T SX
B TB
(mmHg) T
15 0.25 0.35 0.59 0.73

40 0.40 0.30 0.43 0.66
60 0.50 0.35 0.79 1.00
80 0.70 0.40 1.10 1.44
150 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 retested for the ABL800 FLEX
analyzers.
5-14
Performance test results pO2 T T B B
Reference Tonometry [3].

method
The gases used for tonometry are traceable to NIST-certified Standard Reference
Materials.
BiasREF
pO2 (mmHg)
B B Bias REF B B N
15 0.47 60
50 0.24 60
150 0.45 60
250 2.17 60
530 1.01 60
BiasABL blood
samples
Bias (%)
ABL735 (mmHg)
5-15
Performance test results pO2, Continued T T B B T T
Repeatability (%)
ABL835 (mmHg)

Total variation (%)
ABL735 (mmHg)
5-16
Performance test results pO2, Continued T T B B T T
Bias and The bias and imprecision for expired air samples are as follows:
imprecision
expired air
samples pO2 (mmHg)
T B B T Bias T
ABL835/30/25/20/15/10/05 T
15 0.8
40 0.4
130 0.4
230 0.9
570 4.2
Imprecision:
pO2 (mmHg)
T B B T S0
T B TB T SD B TB T SABLB TB T SX
B TB
15 0.3 0.3 1.2 1.3

40 0.3 0.3 1.0 1.1
130 0.3 0.3 0.7 0.8
230 2 2 3 4
570 5 5 13 15
Fifteen ABL700 Series and ABL800 FLEX analyzers are tested over three days for
all levels. Bias is determined against certified gases at sea level.
5-17
Performance test results cK+ P P
Reference NIST-certified Standard Reference Material SRM 909b (human serum).

method
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested using SRM
909b:
cK+ (mmol/L)
P P Bias REF B B N
3.424 0.03 20
6.278 0.23 20
BiasABL blood
samples
Bias (%)
ABL735 (mmol/L)
5-18
Performance test results cK+, Continued T T P P T T
Repeatability (%)
ABL800 FLEX (mmol)L)
Total variation (%)
ABL735 (mmol/L)
5-19
Performance test results cNa+ T T P P
Reference NIST-certified Standard Reference Material SRM 909b (human serum) and
method Radiometer specified standard serum material (specified using flame photometry).
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested:
cNa+ (mmol/L)
P P Bias REF B B N
120.76* 0.25 20
138.5** 0.28 30
N = number of measurements on several analysers used for the test.
(*NIST-certified Standard Reference Material
** Serum (Radiometer-specified).
BiasABL blood
samples
Bias (%)
ABL735 (mmol/L)
5-20
Performance test results cNa+, Continued P P T T
Repeatability (%)
ABL800 FLEX (mmol/L)
Total variation (%)
ABL735 (mmol/L)
5-21
Performance test results cCl T T P P
Reference NIST-certified Standard Reference Material SRM 909b (human serum).

method
BiasREF
B B The FLEXMODE on the ABL805/35 FLEX analyzers was tested using SRM
909b:
cCl (mmol/L)
P P Bias REF B B N
89.11 0.6 20
119.43 2.4 20
BiasABL blood
samples
Bias (%)
ABL735 (mmol/L)
5-22
Performance test results cCl, Continued P P T T
Repeatability (%)
Total variation (%)
ABL735 (mmol/L)
5-23
Performance test results cCa2+ P P
Reference The calcium transfer standards were used. These are traceable to NIST SRM915
method and have an ionic strength of 160.0 mmol per kg of water and pH 7.40 at 37 C,
using 1 mmol/L (37 C) HEPES buffer.
The standards were produced as indicated in [4].
BiasREF
cCa2+ (mmol/L)
P P BiasREFB B N
0.4879 0.038 150
1.2700 0.025 150
2.5657 0.052 150
BiasABL blood
samples
Bias (%)
ABL735 (mmol/L)
5-24
Performance test results cCa2+, Continued T T P P T T

Repeatability (%)

Total variation (%)
ABL735 (mmol/L)
5-25
Performance test results cGlu
Reference Spectrophotometry, using the hexokinase (HK) method recommended by NCCLS

method [5], measured on serum.
BiasREF
cGlu(mmol/L) BiasREF
B B N
0.08 0.03 30
2.09 0.06 30
5.08 0.12 30
14.73 0.02 30
BiasABL blood
samples
Bias (%)
ABL735 (mmol/L)
5-26
Performance test results cGlu, Continued T T T T
Repeatability (%)
Total variation (%)
ABL735 (mmol/L)
5-27
Performance test results cLac
Reference Spectrophotometry using a lactate dehydrogenase (LDH) method, measured on

method serum [10].
BiasREF
cLac (mmol/L) BiasREF

B B N
0.36 -0.08 30
2.06 0.12 30
8.3 0.81 30
11.3 0.62 30
BiasABL blood
samples
Bias (%)
ABL735 (mmol/L)
5-28
Performance test results cLac, Continued T T T T

Repeatability (%)

Total variation (%)
ABL735 (mmol/L)
5-29
Performance test results ctHb T T
Reference HiCN method recommended by NCCLS [6].

method
BiasREF
ctHb (mmol/L) BiasREF

B B N
15 (SAT0) 0.32 145
7 (SAT100) 0.04 145
15 (SAT100) 0.37 145
25 (SAT100) 0.97 145
BiasABL
Bias (%)
ABL735 (g/dL)
5-30
Performance test results ctHb, Continued T T
Repeatability (%)
ABL800 FLEX (g/dL)
Total variation (%)
ABL735 (g/dL)
5-31
Performance test results oximetry
Explanation The optical system is unchanged in the ABL800 FLEX analyzers compared to the
ABL700 Series. Test of ctHb on the ABL800 FLEX analyzers has been conducted
T T
(results given on pages 5-31 to 5-32). The other oximetry parameters have not been
retested; the information and results below are from the ABL700 Series.
Reference The reference method established for the oximetry parameters uses modified
methods ABL520 analyzers as the reference instruments. The ABL520 analyzers have been
validated and their performance specifications determined according to primary
reference methods.
The modified ABL520 analyzers are used in accordance with IFCCs
recommendations for traceability of reference methods.
The reference methods used for the oximetry parameters on the ABL520 analyzers
are those presented below.
Parameter Primary reference method

sO2B B Tonometry: whole blood is tonometered with a gas
mixture containing 94.4 % O2 and 5.6 % CO2.
B B B B
FHHb The standard is blood (ctHb = 13-15 g/dL) treated

T T
with dithionite.
FCOHb Gas chromatography. The standards are carbon
monoxide mixtures with atmospheric air, whose
purity is validated in accordance with NIST SRM
1678 (50 ppm CO in N2). B B
FMetHb Spectrometry, modified Evelyn-Malloy method [7].

FHbF Alkali denaturation method [8]. Corresponds to
NCCLS guideline [9].
Test conditions
for oximetry Test Description
parameters Reference To verify that the correction constants have been
accurately determined, 10 analyzers with all
parameters available are tested in C195 mode against
the reference methods.
Each parameter is tested on 3-6 levels over at least
three days, with five repetitions each day.
(Five new analyzers with all parameters available
were tested against the reference methods for FHbF).
Bias for each parameter in the C195 measuring mode
against the reference method is determined.
5-32
Performance test results oximetry, Continued T T
Test conditions
parameters Verification 6-10 ABL700 Series analyzers are tested over at least
(continued)
T
two days for all levels. Bias for the given mode is
calculated as difference compared to the C195 mode.
Bias against the reference method is determined as
follows:
Bias = bias against C195 + C195 bias against
reference method.
The following parameters: sO2, FCOHb, FMetHb and
B B
FO2Hb are measured directly against the reference

B B
built into the analyzer, and these parameters are

independent of the reference method.
Reduced verification 6-10 new analyzers are used over at least one day for
selected levels.
Bias for the tested mode is calculated as follows:
Bias = bias against C195 + C195 bias against
reference method.
Modes which are not tested are described as "N/A".
Simple verification 6-10 analyzers are tested at one extreme level over
one day. Bias is not determined; bias values for the
modes with similar wet section programs are used.
The measuring modes were tested as follows:
Test Analyzer Mode

Reference ABL735/25/15 C195
Verification ABL735/25/15 S195, S95, S85, C95, C55, C35 OXI
5-33
sO2
B B
Bias:
macromodes
sO2 (%)
T T B B T ABL835/25/15
T T ABL830/20/10
T T
ctHb (g/dL)
T T T T sO2 (%) T B B T T S195 T FM*
T T T S85 T
15 0 0.00 0.05 0.02

7 100 0.01 0.22 N/A
15 100 0.01 0.08 0.00
25 100 0.00 0.29 N/A
* FM = FLEXMODE (no message) corresponding to C195 mode on the
ABL735/25/15.
Imprecision:
ctHb (g/dL)
T T T T sO2 (%) B B T T S0 B TB T SD B TB SABL
T B TB SX
T B TB
15 0 0.05 0.05 0.25 0.30

7 100 0.10 0.10 0.25 0.30
15 100 0.05 0.10 0.25 0.30
25 100 0.05 0.10 0.30 0.35
sO2
B B Bias:
micromodes
sO2
T B TB T ABL835/25/15 T T ABL830/20/10 T
ctHb T T sO2
T B B T S95 T T C95 T T S85 T C55
T T C35
T T FM*
T T T C55 T T C35 T
(g/dL) T (%) T
15 0 -0.04 -0.02 -0.02 -0.03 -0.03 N/A -0.03 -0.03

7 100 -0.10 -0.19 N/A -0.22 -0.10 N/A -0.22 -0.10
15 100 -0.10 -0.16 0.00 -0.16 -0.10 -0.05 -0.16 -0.10
25 100 -0.10 -0.17 N/A -0.14 -0.09 N/A -0.14 -0.09
* FM = FLEXMODE (no message) corresponding to C195 mode on the
ABL735/25/15.
Imprecision: T
T ctHb (g/dL) T sO2 (%) B B S0 B B SD B B SABL B B SX B B
15 0 0.05 0.05 0.25 0.30

7 100 0.10 0.10 0.25 0.30
15 100 0.05 0.10 0.25 0.30
25 100 0.05 0.10 0.30 0.35
5-34
FO2Hb
B B Bias:
macromodes
FO2Hb B B ABL835/25 ABL830/20
ctHb (g/dL)
T T FO2Hb (%)
T T B B S195 FM* S85
15 0 0.00 0.04 0.02
7 100 0.07 N/A N/A
15 100 0.03 N/A 0.15
25 100 0.05 N/A N/A
* FM = FLEXMODE (no message)
Imprecision:
ctHb (g/dL)
T T FO2Hb B B S0
B B SDB B SABL
B B SX
B B
(%)
15 0 0.05 0.05 0.25 0.30
7 100 0.25 0.20 0.50 0.60
15 100 0.15 0.15 0.45 0.50
25 100 0.10 0.10 0.40 0.45
FO2Hb
B B Bias:
micromodes
FO2Hb (%)
B B ABL835/25
ctHb (g/dL)
T T FO2Hb (%)
T T B B S95 C95 S85 C55 C35
15 0 0.04 0.02 0.02 0.03 0.03
7 100 0.47 0.39 N/A 0.48 0.18
15 100 0.33 0.40 0.15 0.39 0.31
25 100 0.29 0.46 N/A 0.36 0.33
FO2Hb B B ABL830/20
ctHb (g/dL)
T T FO2Hb (%)
T T B B C85 C55 C35
15 0 N/A 0.03 0.03
7 100 N/A 0.48 0.18
15 100 0.16 0.39 0.31
25 100 N/A 0.36 0.33
5-35
FO2Hb
T T B B Imprecision:
micromodes
ctHb (g/dL) FO2Hb (%) S0 SD SABL SX
(continued)
T T B B B B B B B B B B
T T
15 0 0.05 0.05 0.25 0.30

7 100 0.25 0.20 0.50 0.60
15 100 0.15 0.15 0.45 0.50
25 100 0.10 0.10 0.40 0.45
FCOHb Bias:
macromodes
FCOHb ABL835/25 ABL830/20
ctHb (g/dL)
T T sO2 (%)
B B FCOHb
T T S195 FM* S85
(%)
15 100 0 0.03 0.08 0.12
7 100 20 N/A 0.47 N/A
15 100 20 N/A 0.10 N/A
25 100 20 N/A 0.47 N/A
Imprecision:
ctHb (g/dL)
T T sO2 (%)
B B FCOHb (%) S0
B B SD B B SABL
B B SX
B B
15 100 0 0.05 0.10 0.35 0.40

7 100 20 0.10 0.10 0.75 0.80
15 100 20 0.05 0.10 0.70 0.75
25 100 20 0.05 0.10 0.70 0.75
Imprecision (ABL837/27):
ctHb (g/dL)
T T sO2 (%)
B B FCOHb (%) S0
B B SD B B SABL
B B SX
B B
15 100 0 0.05 0.10 0.35 0.40

7 100 20 0.10 0.10 0.75 0.80
15 100 20 0.05 0.10 0.70 0.75
25 100 20 0.05 0.10 0.70 0.75
5-36
FCOHb Bias:
micromodes
FCOHb ABL835/25
ctHb T T sO2
B B FCOHb
T T S95 C95 S85 C55 C35
(g/dL) (%) (%)
15 100 0 0.10 0.10 0.12 0.08 0.08
7 100 20 N/A N/A N/A N/A N/A
15 100 20 N/A N/A N/A N/A N/A
25 100 20 N/A N/A N/A N/A N/A
FCOHb ABL830/20
ctHb (g/dL)
T T sO2 (%) B B FCOHb (%)
T T FM* C55 C35
15 100 0 0.02 0.08 0.08
7 100 20 N/A N/A N/A
15 100 20 N/A N/A N/A
25 100 20 N/A N/A N/A
Imprecision:
ctHb (g/dL)
T T sO2 (%)
T T B B FCOHb (%) S0 B B SD
B B SABL
B B SXB B
15 100 0 0.05 0.10 0.35 0.40

7 100 20 0.10 0.10 0.75 0.80
15 100 20 0.05 0.10 0.70 0.75
25 100 20 0.05 0.10 0.70 0.75
FMetHb Bias:
macromodes
FMetHb ABL835/25 ABL830/20
ctHb (g/dL)
T T sO2 (%) B B FMetHb (%)
T T S195 FM* S85
15 100 0 0.01 0.03 0.06
15 100 20 N/A 0.10 N/A
5-37
FMetHb
T T Imprecision:
macromodes
ctHb (g/dL) sO2 (%) FMetHb (%) S0 SD SABL SX
(continued)
T T B B T T B B B B B B B B
T T
15 100 0 0.10 0.10 0.25 0.30

15 100 20 0.05 0.10 0.35 0.40
FMetHb
T T Bias:
micromodes
FMetHb ABL835/25
TctHb T sO2 (%)
B B FMetHb
T T S95 C95 S85 C55 C35
(g/dL) (%)
15 100 0 0.13 0.14 0.06 0.16 0.14
7 100 20 N/A N/A N/A N/A N/A
15 100 20 N/A N/A N/A N/A N/A
25 100 20 N/A N/A N/A N/A N/A
FMetHb ABL830/20
ctHb (g/dL)
T T sO2 (%) B B FMetHb (%)
T T FM* C55 C35
15 100 0 0.13 0.16 0.14
7 100 20 N/A N/A N/A
15 100 20 N/A N/A N/A
25 100 20 N/A N/A N/A
Imprecision:
ctHb (g/dL)
T T sO2 (%)
T T B B FMetHb(%) S0
B B SD B B SABL
B B SXB B
15 100 0 0.10 0.10 0.25 0.30

15 100 20 0.05 0.10 0.35 0.40
5-38
FHHb Bias:
macromodes
FHHb ABL835/25 ABL830/20
FHHb (%)
T T ctHb (g/dL)
T T S195 FM* S85
0 15 0.01 0.08 0.05
Imprecision:
FHHb (%) ctHb (g/dL)
T T S0
B B SD B B SABL
B B SXB B
0 15 0.05 0.10 0.30 0.35
FHHb Bias:
micromodes
FHHb ABL835/25 ABL830/20
TctHb T FHHb S95 C95 S85 C55 C35 FM* C55 C35
(g/dL) (%)
15 0 0.09 N/A N/A 0.15 0.10 N/A N/A 0.10
Imprecision:
ctHb (g/dL)
T T FHHb (%) S0
B B SD B B SABL B B SX B B
15 0 0.05 0.10 0.30 0.35
FHbF adult Bias (macromodes):

blood
FHbF ABL835 ABL830
FHbF (%) ctHb (g/dL)
T T S195 FM* S85
0 10 3.3 3.3 3.3
0 15 5.5 5.5 5.5
0 20 5.6 5.6 5.6
Imprecision (macromodes):
T T sO2 (%)
B B S0
B B SD
B B SABL B B SX B B
0 10 100 4 4 5 8
0 15 100 2 3 7 8
0 20 100 2 2 10 11
5-39
FHbF adult Bias (micromodes):

blood
FHbF ABL835 ABL830
(continued)
T T
ctHb
T T FHbF
T T S95 C95 S85 C55 C35 FM* C55 C35
(g/dL) (%)
1 0 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3
0
1 0 5.5 5.5 5.5 5.5 5.5 5.5 5.5 5.5
5
2 0 5.6 5.6 5.6 5.6 5.6 5.6 5.6 5.6
0
Imprecision (micromodes):
ctHb (g/dL)
T T FHbF (%)
T T sO2 (%)
B B S0
B B SD
B B SABLB B SX B B
10 0 100 4 4 5 8
15 2 3 5 7
20 2 2 10 11
NOTES: a, b.
FHbF fetal Bias (macromodes):

blood
FHbF ABL835 ABL830
T T S195 FM*
80 10 5.9 5.9 5.9
80 15 3.3 3.3 3.3
80 20 2.6 2.6 2.6
Imprecision (macromodes):
T T sO2 (%)
T T B B S0
B B SD
B B SABL
B B SX
B B
80 10 100 4 5 5 9
80 15 100 3 3 6 8
80 20 100 2 3 6 7
NOTES: a, b.
5-40
FHbF fetal Bias (micromodes):

blood
FHbF ABL835 ABL830
(continued)
T T
TctHb
T FHbF S95 C95 S85 C55 C35 FM* C55 C35
(g/dL) (%)
10 80 5.9 5.9 5.9 5.9 5.9 5.9 5.9 5.9
15 80 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3
20 80 2.6 2.6 2.6 2.6 2.6 2.6 2.6 2.6
Imprecision (micromodes):
T T sO2 (%)
B B S0B B SD
B B SABL
B B SX
B B
80 10 100 4 5 6 9
15 3 3 6 8
20 2 3 6 7
NOTES: a, b.
Contribution to The following corrections should be geometrically added to SInst and SX for the B B B B
Imprecision analyzer's wavelength calibrated with the S7770:

Specifications
Parameter Mode Level Correction
from S7770
(percentage
point)
ctHb
T T Macromode All 0
Micromode All 0
sO2 B B All sO2 (100 %)
B B 0.23
FO2Hb B B All FO2Hb (100 %)
B B 0.15
FCOHb All FCOHb (20 % and 0 %) 0.40
FHHb All FHHb (0 %) 0.23
NOTES:
a. pH = 7.4 0.1. FHbF is adjusted with the pH sensitivity to a nominal

pH = 7.4. For further details please refer to the Interference Tests section T T
for oximetry parameters.

b. Specifications for imprecision are derived from worst-case values found
during internal laboratory tests. 40 % relative is then added as a safety
factor.
5-41
Performance test results bilirubin
Explanation As the optical system is unchanged in the ABL800 FLEX analyzers compared to
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 the bilirubin algorithm for neonatal blood
samples.
For neonatal use: The bilirubin method has been evaluated on whole blood
and plasma. The allowed analytical error is 10 % to
satisfy average clinical requirements for bilirubin
measurement [1,2,3,4,5]. This requirement is fulfilled for
plasma. For whole blood the analytical error is slightly
higher. The clinicians and clinical chemists have evaluated
bilirubin measurement on whole blood, the conclusion
being that the ABL735/30 analyzers have satisfactory
performance and can substitute other bilirubin measuring
methods.
For adult use: Adult samples within reference range:
The uncertainty in the bilirubin measurement on whole
blood can, in some cases, exceed the level required to
measure normal bilirubin levels for children older than 3
months and adults (bilirubin reference range 4-22 mol/L).
In these cases it is recommended to measure bilirubin on
plasma or serum.
Adult samples with an increased bilirubin level:

Adult field tests were typically performed on samples with
80 % of the total bilirubin in the conjugated form. For these
highly conjugated samples the field tests showed a negative
bias of 7 % on both plasma and whole blood samples.
The patient samples represented typical variations in ctBil, ctHb, sO2, pH and
T T T T B B
MCHC values.
A Hitachi analyzer calibrated with NIST SRM 916a standards was used as a
reference. ctBil was measured in mol/L. Each field test place had its own
T T
ABL735 analyzer.
5-42
Performance test results bilirubin, Continued T T
Field test results The field test results are given below.
(continued)
T
Pos. Field test Type N Slope Inter- R2 Syx Range

place
cept mol/L mol/L
mol/L
1 A Plasma, 46 1.026 0.0 0.9914 5.1 18-258
2 B neonatal 56 0.986 1.3 0.9939 5.8 10-334
3 D 4 1.014 1.4 0.9984 4.5 22-236
4 E 47 0.945 1.2 0.9937 5.1 4-253
5 D Plasma, 16 0.950 0.5 0.9977 5.2 18-313

6 B adult 59 0.924 1.4 0.9981 3.8 2-366
7 F 52 0.904 5.6 0.9932 12.0 4-635
45 (a) 0.942 2.6 0.9941 5.3 4-300
8 A Blood, 46 1.075 9.6 0.9661 10.7 18-258

9 B neonatal 100 1.057 1.6 0.9819 12.0 3-297
10 D 32 1.000 5.6 0.9715 14.4 3-254
11 C 52 0.993 5.0 0.9790 11.3 6-309
12 E 47 1.019 10.2 0.9827 9.5 4-253
13 D Blood, 18 0.950 6.8 0.9974 5.6 18-313

14 B adult 55 0.909 3.2 0.9974 4.6 2-366
15 F 25 0.939 4.9 0.9967 10.0 21-635
Regression table: Regression results from field tests. N = #samples, Sy/x is standard
B B
deviation about regression line.
NOTE: (a) Datasubset excluding samples above 300 mol/L.
5-43
Regression and Data set position 9 from regression table.

Bland-Altman
plot 350
y = 1.0572x - 1.6119
2
R = 0.9819
300
250
200
ABL735
Syx=12.0
150
100
50
0
0 50 100 150 200 250 300
Hitachi, NIST
Actual field test from a neonatal critical care hospital using whole blood. Values
are in mol/L.
The same data as above but depicted in a Bland-Altman plot below.
50
40
30
Difference
20
10
0
0 50 100 150 200 250 300
-10
-20
ctBil
Lines indicate Mean, Mean+2SD and Mean2SD. Values are in mol/L.

Difference = ABL835 Hitachi, NIST.
5-44
Imprecision The following parameters are used to describe performance of the ABL835/30
parameters FLEX analyzers for bilirubin measurements.
S0:
B B Repeatability. Measurement short time interval variation on the same
sample
SD:
B B Day-to-day variation
ST:
B B Patient-to-patient variation
S I:
B B ABL-to-ABL instrumental variation
SABL:
B B ABL uncertainty. Variation including ST, SI and reference uncertainty
B B B B
SX:
B B Reproducibility. Total variation including S0, SD and SABL B B B B B B
The above field test regression statistics Syx include variations from S0, SD and ST.
B B B B B B B
Performance Macromodes: 195 L and 85 L from syringe and capillary:

test results for
bilirubin
ctBil T T ctHb
T T sO2 (%)
T T B B S0
B B SD
B B ST
B B SI B B SABLB B SX B B
(mol/L) (g/dL)
0 Plasma 1.1 1.4 2.2 0.4 2.3 2.9
0 10 100 1.9 3.1 4.0 3.2 5.1 6.3
0 15 100 2.3 2.9 7.4 5.5 9.2 9.9
0 20 100 3.4 2.6 10.9 13.0 17.0 17.5
200 Plasma 1.3 1.7 3.1 4.7 7.4 7.7
200 10 100 2.4 4.4 5.8 6.6 10.1 11.3
200 15 100 2.6 3.7 8.5 9.3 13.6 14.4
200 20 100 4.2 5.0 12.1 15.4 20.4 21.4
400 Plasma 1.7 2.5 4.8 9.3 12.0 12.3
400 10 100 3.5 6.8 9.3 12.0 16.5 18.2
400 15 100 3.4 5.3 11.4 15.9 20.8 21.7
400 20 100 6.0 8.8 15.0 21.0 27.1 29.2
Notes: a, b, c
5-45
Performance Micromodes: 95 L syringe and capillary, 55 L and 35 L capillary:

test results for
bilirubin
(continued)
T T
ctBil
T T ctHb
T T sO2
T T B B S0
B B SDB B STB B SI
B B SABL
B B SXB B
(mol/L) (g/dL) (%)

0 Plasma 1.1 1.4 2.2 0.4 2.3 2.9
0 10 100 1.9 3.1 4.0 3.2 5.1 6.3
0 15 100 2.3 2.9 7.4 5.5 9.2 9.9
0 20 100 3.4 2.6 10.9 13.0 17.0 17.5
200 Plasma 2.0 1.7 2.9 3.9 6.8 7.3
200 10 100 3.7 3.9 6.0 5.6 9.6 11.0
200 15 100 4.4 4.2 9.3 7.9 13.2 14.6
200 20 100 5.6 5.9 13.0 16.3 21.6 23.1
400 Plasma 3.5 2.5 4.3 7.8 10.6 11.4
400 10 100 6.7 5.7 9.9 9.6 15.2 17.6
400 15 100 7.9 6.7 13.5 12.5 19.7 22.3
400 20 100 9.5 10.9 17.8 23.6 30.7 33.9
Notes: a, b, c
NOTES:
a. Adult/fetal blood, pH = 7.4 0.1, normal MCHC and albumin variation.

Spiked with unconjugated bilirubin.
b. ctBil specification at level 200 mol/L is interpolated from the measured
T T
specifications at 0 and 400 mol/L.

c. 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. Arch Pathol Lab Med 1988; 112: 402-15.
2. Ehrmeyer SS, Laessig RH, Leinweber JE, Oryall JJ. 1990 Medicare/CLIA
final rules for proficiency testing: minimum intralaboratory performance
characteristics (CV and bias) needed to pass. Clin Chem 1990; 36, 10: 1736-
40.
5-46
References 3. Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications
(continued)
T T for the imprecision and inaccuracy of analytical systems for clinical chemistry.
Eur J CLin Chem Clin Biochem 1992; 30: 311-17.
4. Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory test
based on clinical and analytical test outcome criteria. Clin Chem 1994; 40, 10:
1909-14.
5. Vanderline RE, Goodwine J, Koch D, Scheer D, Steindel S, Cembrowski G.
Guidelines for providing quality stat laboratory services. 1987 Laboratory
Quality Assurance Commitee.
5-47
Additional information about FLEXMODE
Introduction With the FLEXMODE

Varying sample volumes can be introduced to obtain a given parameter profile,
and
Two different parameter profiles can be reported for the same sample volume as
the sample volume intervals overlap one another.
See the ABL800 FLEX Operators Manual, chapter 4, page 4-3, for an overview of
T T
sample volume intervals and parameter profiles.
Most of the variation contributed by the difference in sample volume and

parameter profile is included in the performance test results (bias, repeatability and
imprecision) given in this chapter. Special tests with emphasis on extreme
scenarios were conducted. The following scenarios were studied:
Bias and repeatability for minimum and maximum sample volumes
Bias and repeatability for parameter profiles with same sample volume
These special studies were conducted for each of the individual parameter profiles.
The parameters with the variation exceeding the Performance Characteristics are
listed below.
Worst-case Sample volume < 55 L:

observations
Parameter Values Bias Repeatability
pH 7.15 0.015 0.005
7.40 0.013 0.005
pCO2 (mmHg)
B B 29 1.0 0.9
80 -2.9 2.6
pO2 (mmHg)
B B 130 3.0 3.9
230 -3.7 3.6
5-48
ABL8x7 Performance characteristics
Overview
Introduction This chapter describes performance characteristics of the ABL8x7 FLEX analyzers
for each measured parameter and test conditions to obtain them.
Contents This section contains the following topics.

Test conditions ................................................................................................. 5-50
X X
Performance test results pH, pCO2, pO2 ....................................................... 5-51

B B B B X X
Performance test results electrolytes ............................................................. 5-54 X X
Performance test results cGlu, cLac.............................................................. 5-58 X X
Performance test results ctHb........................................................................ 5-60 X X
Performance test results oximetry ................................................................. 5-61 X X
Performance test results bilirubin.................................................................. 5-70 X X
Performance test conditions and results cCrea.............................................. 5-72 X X
Interference tests .............................................................................................. 5-92

X X
References ........................................................................................................ 5-103

X X
5-49
Test conditions
ABL8x7 Test conditions to determine biasABL and imprecision for pH, pCO2, pO2, cCa2+,
B B B B B B P P
cCl, cK+, cNa+, cGlu, cLac, ctHb were as follows:

P P P P P P
Item Description
Reference analyzers Five ABL735 with AutoCheck module were used as a
reference. The C195 mode was used as a reference for
all measured parameters.
Primary reference As specified for each parameter further in this chapter.
methods
Analyzers and test Ten ABL837 were tested over 30 days in the
modes following modes:
Syringe: S250
Capillary: C125, C35 MET
Blood samples Heparinized blood samples from healthy, voluntary
donors.
The blood is prepared to obtain the different
concentration levels of each measured parameter.
Blood measurements The measurements were performed by different
operators.
Calibration solution and All calibration solutions and gases used for the tests
gases are traceable to Primary Reference Standards.
Traceability certificates for the ABL8x7 FLEX
calibration solutions and gases are found at the end of
chapter 7: Solutions.
T T

conditions
Test conditions for cCrea see pages 5-73 to 5-86 in this chapter.
T T
NOTES:
T
The solutions used in the performance tests are those recommended by
T
Radiometer. Performances using other solutions cannot be guaranteed.

The performance tests are performed under conditions where the analyzers are
T
not influenced by electromagnetic fields. T
5-50
Performance test results pH, pCO2, pO2 T T B B T T B B
Reference
methods Parameter Reference method
pH Capillary-type glass pH electrode with a saturated
calomel reference electrode and a liquid junction
saturated with KCl (BMS Mk2) [1,2].
pCO2 and pO2
B B B B
Tonometry [3].
The gases used for tonometry are traceable to NIST-
certified Standard Reference Material SRM 1701a,
1702a, 1703a.
pH S250 mode bias:
pH Bias
7.0 0.003
7.4 0.002
7.7 0.005
S250 mode imprecision:

pH S0
B B SDB B SABL
B B SXB B
7.0 0.0035 0.0024 0.0061 0.0080

7.4 0.0020 0.0019 0.0070 0.0080
7.7 0.0030 0.0024 0.0100 0.0110
C125 mode bias:
pH Bias
7.0 0.004
7.4 0.001
7.7 0.001
C125 mode imprecision:

pH S0
B B SDB B SABL
B B SXB B
7.0 0.0053 0.0036 0.0070 0.0120

7.4 0.0030 0.0029 0.0079 0.0120
7.7 0.0050 0.0036 0.0108 0.0150
5-51
Performance test results pH, pCO2, pO2, Continued T T B B T T B B T T
pCO2 B B S250 mode bias:

pCO2 (mmHg)
B B Bias
10 0.26
28 0.01
40 0.26
60 0.03
80 0.12
150 1.37

pCO2 B B S0
B B SDB B SABL
B B SX
B B
(mmHg)
10 0.25 0.35 0.51 0.90
40 0.40 0.30 0.59 0.70
60 0.60 0.50 1.10 1.80
80 0.80 0.80 1.40 2.40
150 1.50 2.00 3.76 6.10
C125 mode bias:

pCO2 (mmHg)
B B Bias
10 0.56
40 0.07
60 0.19
80 0.01
150 2.93

pCO2 B B S0
B B SDB B SABL
B B SX
B B
(mmHg)
10 0.38 0.40 0.80 1.40
40 0.60 0.45 0.85 1.80
60 0.90 0.75 1.60 2.70
80 1.20 1.20 2.01 3.60
150 2.70 1.20 4.83 7.40
5-52
Performance test results pH, pCO2, pO2, ContinuedT T B B T T B B T T
pO2
B B S250 mode bias:
pO2 (mmHg)B B Bias
15 0.42
50 0.33
150 0.11
230 3.82
550 23.4

pO2 (mmHg)
B B S0
B B SDB B SABL
B B SX
B B
15 0.40 0.28 0.58 1.00

50 0.45 0.38 0.62 1.10
150 0.90 1.00 1.64 2.80
230 3.00 2.00 3.15 6.00
550 7.00 6.60 9.69 18.00
C125 mode bias:

pO2 (mmHg)B B Bias
15 0.50
50 0.47
150 1.29
230 7.17
550 18.66

pO2 (mmHg)
B B S0
B B SDB B SABL
B B SX
B B
15 0.70 0.42 0.86 1.50

50 0.68 0.57 0.88 2.00
150 1.40 1.50 2.34 5.00
230 4.50 3.00 4.52 9.00
550 10.50 9.90 14.25 27.00
5-53
Performance test results electrolytes
Reference
cK+, cNa+, cCl
T T P P T T P P T T P P The standard sodium and potassium solutions are
traceable to NIST-certified Standard Reference Material
SRM 909b (human serum)
cCa2+
T T P P Radiometer method used.
The standard calcium solutions used are validated
against corresponding NIST standard SRM 915 [4].
cK+
P P S250 mode bias:
cK+ (mmol/L) P P Bias

2 0.08
4 0.06
8 0.04

cK+ (mmol/L) P P S0
B B SD
B B SABL
B B SX
B B
2 0.020 0.010 0.078 0.090

4 0.040 0.020 0.080 0.100
8 0.030 0.038 0.122 0.160
C125 mode bias:
cK+ (mmol/L) P P Bias

2 0.04
4 0.01
8 0.03

cK+ (mmol/L) P P S0
B B SD
B B SABL
B B SX
B B
2 0.060 0.025 0.093 0.140

4 0.060 0.048 0.106 0.170
8 0.080 0.070 0.144 0.230
5-54
Performance test results electrolytes, Continued T T
cNa+
P P S250 mode bias:
cNa+ (mmol/L)
P P Bias
120 0.58
140 0.69
180 0.57

cNa+ (mmol/L)
P P S0
B B SDB B SABL
B B SX
B B
120 0.40 0.30 0.97 1.30

140 0.40 0.30 1.05 1.30
180 0.50 0.30 1.41 1.65
C125 mode bias:
cNa+ (mmol/L)
P P Bias
120 0.43
140 0.03
180 0.41

cNa+ (mmol/L)
P P S0
B B SDB B SABL
B B SX
B B
120 0.60 0.65 1.28 1.95

140 0.60 0.68 1.28 1.95
180 0.60 0.60 1.55 2.10
5-55
cCl
P P S250 mode bias:
cCl (mmol/L) P P Bias

85 0.62
105 0.57
140 0.63

cCl (mmol/L)
P P S0
B B SDB B SABL
B B SX
B B
85 0.50 0.40 1.07 1.50

105 0.45 0.40 1.24 1.60
140 0.50 0.45 1.86 2.20
C125 mode bias:
cCl (mmol/L) P P Bias

85 1.22
105 0.38
140 1.23

cCl (mmol/L)
P P
S0
B B SDB B SABL
B B SX
B B
85 0.75 0.72 1.28 2.25

105 0.75 0.75 1.40 2.40
140 0.75 1.10 2.11 3.30
5-56
cCa2+
P P S250 mode bias:
cCa2+ (mmol/L)
P P Bias
0.5 0.012
1.25 0.010
2.5 0.008

cCa2+ (mmol/L)
P P S0
B B SD
B B SABL
B B SXB B
0.5 0.008 0.003 0.013 0.019

1.25 0.008 0.005 0.016 0.021
2.5 0.010 0.012 0.030 0.040
C125 mode bias:
cCa2+ (mmol/L)
P P Bias
0.5 0.003
1.25 0.023
2.5 0.046

cCa2+ (mmol/L)
P P S0
B B SD
B B SABL
B B SXB B
0.5 0.013 0.020 0.027 0.050

1.25 0.013 0.020 0.028 0.050
2.5 0.015 0.018 0.039 0.059
5-57
Performance test results cGlu, cLac T T T T
Reference
cGlu
T T Spectrophotometry, using the hexokinase (HK) method
recommended by NCCLS [5], measured on serum
cLac
T T Spectrophotometry using a lactate dehydrogenase (LDH) method,
measured on serum.
cGlu S250 mode bias:
cGlu (mmol/L) Bias

2 0.02
5 0.12
15 0.21

cGlu (mmol/L) S0 B B SDB B SABLB B SX
B B
2 0.10 0.06 0.12 0.20

5 0.10 0.05 0.23 0.30
15 0.35 0.14 0.50 0.70
C125 mode bias:
cGlu (mmol/L) Bias

C125 C35
2 0.03 0.07
5 0.06 0.04
15 0.12 0.25

cGlu (mmol/L) S0 B B SDB B SABLB B SX
B B
2 0.15 0.08 0.17 0.30

5 0.15 0.13 0.29 0.50
15 0.60 0.30 0.60 1.10
5-58
Performance test results cGlu, cLac, Continued

T T T T T T
cLac S250 mode bias:
cLac (mmol/L) Bias

0.3 0.08
2 0.01
10 0.42

cLac (mmol/L) S0 B B SDB B SABL
B B SXB B
0.3 0.10 0.06 0.13 0.23

2 0.10 0.06 0.15 0.23
10 0.20 0.20 0.61 0.85
C125 mode bias:
cLac (mmol/L) Bias

C125 C35
0.3 0.09 0.03
2 0.15 0.04
10 0.20 0.15

cLac (mmol/L) S0 B B SDB B SABL
B B SXB B
0.3 0.15 0.12 0.19 0.35

2 0.15 0.10 0.21 0.35
10 0.45 0.30 0.73 1.30
5-59
Performance test results ctHb T T
Reference
method Parameter Reference method
ctHb
T T
HiCN method recommended by NCCLS [6].
ctHb S250 bias:

ctHb (g/dL) sO2 (%)
B B Bias
15 0 0.06
7 100 0.03
15 100 0.06
25 100 0.48

ctHb sO2 (%)
B B S0
B B SD
B B SABL
B B SXB B
(g/dL)
15 0 0.30 0.09 0.27 0.40
7 100 0.30 0.13 0.22 0.40
15 100 0.30 0.10 0.27 0.40
25 100 0.50 0.10 0.48 0.70
C125 bias:
ctHb (g/dL) sO2 (%)
B B Bias
15 0 0.19
7 100 0.08
15 100 0.12
25 100 0.11

ctHb sO2 (%)
B B S0
B B SD
B B SABL
B B SXB B
(g/dL)
15 0 0.50 0.15 0.36 0.80
7 100 0.50 0.20 0.352 0.80
15 100 0.50 0.17 0.35 0.80
25 100 0.70 0.15 0.66 1.00
5-60
Performance test results oximetry
Explanation The optical system is unchanged in the ABL800 FLEX analyzers compared to the
ABL700 Series. Test of ctHb on the ABL800 FLEX analyzers has been conducted
T T
(results given on the previous page). The other oximetry parameters have not been
retested; the information and results below are from the ABL700 Series.
Reference
Oximetry The reference method established for the oximetry
parameters uses modified ABL520 analyzers as the field
reference instruments. The ABL520 analyzers have been
validated and their performance specifications
determined according to primary reference methods.
The modified ABL520 analyzers are used in accordance
with IFCCs recommendations for traceability of
reference methods.
The reference methods used for the oximetry parameters
on the ABL520 analyzers are those presented below.
sO2
B B Tonometry: whole blood is tonometered with a gas
mixture containing 94.4 % O2 and 5.6 % CO2.
B B B B
FHHb The standard is blood (ctHb = 13-15 g/dL) treated with

T T
dithionite.
FCOHb Gas chromatography. The standards are carbon
monoxide mixtures with atmospheric air, whose purity is
validated in accordance with NIST SRM 1678 (50 ppm
CO in N2).
B B
FMetHb Spectrometry, modified Evelyn-Malloy method [7].

FHbF Alkali denaturation method [9]. Corresponds to NCCLS
guideline [10].
Test conditions
parameters Reference To verify that the correction constants have been
accurately determined, 10 analyzers with all parameters
available are tested in C195 mode against the reference
methods.
Each parameter is tested on 3-6 levels over at least three
days, with five repetitions each day.
(Five new analyzers with all parameters available were
tested against the reference methods for FHbF.)
Bias for each parameter in the C195 measuring mode
against the reference method is determined.
5-61
Test conditions
parameters Verification 6-10 ABL700 Series analyzers are tested over at least 2
(continued)
T
days for all levels. Bias for the given mode is calculated
as difference compared to the C195 mode.
Bias against the reference method is determined as
follows:
Bias = bias against C195 + C195 bias against reference
method.
The following parameters: sO2, FCOHb, FMetHb and
B B
FO2Hb are measured directly against the reference built

B B
into the analyzer, and these parameters are independent

of the reference method.
Reduced verification 6-10 new analyzers are used over at least 1 day for
selected levels.
Bias for the tested mode is calculated as follows:
Bias = bias against C195 + C195 bias against reference
method.
Untested modes are described as "N/A".
Simple verification 6-10 analyzers are tested at one extreme level over one
day. Bias is not determined; bias values for the modes
with similar wet section programs are used.
sO2 B B S250 mode bias:

ctHb (g/dL) sO2 (%)
B B Bias
15 0 0.01
7 100 0.12
15 100 0.00
25 100 0.03

ctHb sO2 (%)
B B S0
B B SD
B B SABL
B B SXB B
(g/dL)
15 0 0.50 0.12 0.60 1.00
7 100 0.30 0.15 0.42 0.60
15 100 0.30 0.15 0.45 0.60
25 100 0.50 0.16 0.67 1.00
5-62
sO2 (continued)
T T B B T T C125 bias:
ctHb (g/dL) sO2 (%)
B B Bias
15 0 0.04
7 100 0.14
15 100 0.12
25 100 0.13

ctHb sO2 (%)
B B S0
B B SD
B B SABL
B B SXB B
(g/dL)
15 0 0.50 0.15 0.36 1.00
7 100 0.30 0.20 0.41 0.60
15 100 0.30 0.15 0.42 0.60
25 100 0.50 0.12 0.65 1.00
FO2Hb B B S250 mode bias:

FO2Hb (%)
B B Bias
ctHb (g/dL) sO2 (%)
B B
15 0 0.12
7 100 0.03
15 100 0.02
25 100 0.01

ctHb FO2Hb(%)
B B S0 B B SD B B SABL B B SX B B
(g/dL)
15 0 0.05 0.05 0.25 0.30
7 100 0.25 0.20 0.50 0.60
15 100 0.15 0.15 0.45 0.50
25 100 0.10 0.10 0.40 0.45
5-63
FO2Hb
T T B B C125 mode bias:
(continued)
FO2Hb (%) Bias
T
B B
ctHb (g/dL) sO2 (%)

B B
15 0 0.02
7 100 0.39
15 100 0.40
25 100 0.46

ctHb FO2Hb(%) B B S0
B B SDB B SABL
B B SX B B
(g/dL)
15 0 0.05 0.05 0.25 0.30
7 100 0.25 0.20 0.50 0.60
15 100 0.15 0.15 0.45 0.50
25 100 0.10 0.10 0.40 0.45
FCOHb S250 mode bias:
FCOHb (%) Bias

ctHb (g/dL)
T T sO2 (%)
B B FCOHb (%)
15 100 0 0.03
7 100 20 N/A
15 100 20 N/A
25 100 20 N/A

ctHb sO2 (%)
B B FCOHb S0 B B SD
B B SABL
B B SX B B
g/dL) (%)
15 100 0 0.05 0.10 0.35 0.40
7 100 20 0.10 0.10 0.75 0.80
15 100 20 0.05 0.10 0.70 0.75
25 100 20 0.05 0.10 0.70 0.75
5-64
FCOHb
T T C125 mode bias:
(continued)
T
FCOHb (%) Bias

ctHb (g/dL) sO2 (%)
B B FCOHb (%)
15 100 0 0.10
7 100 20 N/A
15 100 20 N/A
25 100 20 N/A

ctHb sO2 (%)
B B FCOHb S0
B B SD
B B SABL
B B SXB B
g/dL) (%)
15 100 0 0.05 0.10 0.35 0.40
7 100 20 0.10 0.10 0.75 0.80
15 100 20 0.05 0.10 0.70 0.75
25 100 20 0.05 0.10 0.70 0.75
FMetHb S250 mode bias:

FMetHb (%) Bias
ctHb (g/dL)
T T sO2 (%)
B B FMetHb (%)
15 100 0 0.01
7 100 20 N/A

ctHb sO2 (%)
B B FMetHb S0
B B SD
B B SABL
B B SXB B
g/dL) (%)
15 100 0 0.10 0.10 0.25 0.30
7 100 20 0.05 0.10 0.35 0.40
5-65
FMetHb
T T C125 mode bias:
(continued)
FMetHb (%) Bias
T
ctHb (g/dL)
T T sO2 (%)
B B FMetHb (%)
15 100 0 0.14
7 100 20 N/A
15 100 20 N/A
25 100 20 N/A

ctHb sO2 (%)
B B FMetHb S0
B B SD
B B SABL B B SXB B
g/dL) (%)
15 100 0 0.10 0.10 0.25 0.30
7 100 20 0.05 0. 10 0.35 0.40
FHHb S250 mode bias:

FHHb (%) Bias
FHHb (%)
T T ctHb (g/dL)
0 15 0.01

FHHb (%) tHb (g/dL) S0 B B SD
B B SABL
B B SX B B
0 15 0.05 0.10 0.30 0.35
C125 mode bias:

FHHb (%) Bias
FHHb (%)
T T ctHb (g/dL)
0 15 N/A

FHHb (%) ctHb (g/dL)
T T S0 B B SD
B B SABL
B B SX B B
0 15 0.05 0.10 0.30 0.35
5-66
FHbF adult S250 mode bias:

blood
FHbF (%) Bias
FHbF (%)
T T ctHb (g/dL)
0 10 3.3
0 15 5.5
0 20 5.6

FHbF TctHb
T sO2 (%)
T T B B S0
B B SD B B SABL
B B SX
B B
(%) (g/dL)
0 10 100 4 4 5 8
0 15 100 2 3 7 8
0 20 100 2 2 10 11
NOTES: a, b.
C125 mode bias:

FHbF (%) Bias
FHbF (%)
T T ctHb (g/dL)
0 10 3.3
0 15 5.5
0 20 5.6

FHbF TctHb
T sO2 (%)
T T B B S0
B B SD B B SABL
B B SX
B B
(%) (g/dL)
0 10 100 4 4 5 8
0 15 100 2 3 5 7
0 20 100 2 2 10 11
NOTES: a, b.
5-67
FHbF fetal S250 mode bias:

blood
FHbF (%) Bias
FHbF (%)
T T ctHb (g/dL)
0 10 5.9
0 15 3.3
0 20 2.6

FHbF TctHb
T sO2 (%)
T T B B S0
B B SD B B SABL
B B SX
B B
(%) (g/dL)
0 10 100 4 5 5 9
0 15 100 3 3 6 8
0 20 100 2 3 6 7
NOTES: a, b.
C125 mode bias:

FHbF (%) Bias
FHbF (%)
T T ctHb (g/dL)
0 10 5.9
0 15 3.3
0 20 2.6

FHbF TctHb
T sO2 (%)
T T B B S0
B B SD B B SABL
B B SX
B B
(%) (g/dL)
0 10 100 4 5 6 9
0 15 100 3 3 6 8
0 20 100 2 3 6 7
NOTES: a, b.
5-68
Contribution to The following corrections should be geometrically added to SInst and SX for the B B B B
Imprecision analyzer's wavelength calibrated with the S7770:

Specifications
Parameter Mode Level Correction
from S7770
(percentage
point)
ctHb
T T Macromode All 0
Micromode All 0
sO2 B B All sO2 (100 %)
B B 0.23
FO2Hb B B All FO2Hb (100 %)
B B 0.15
FCOHb All FCOHb (20 % and 0 %) 0.40
FHHb All FHHb (0 %) 0.23
NOTES:
a. pH = 7.4 0.1. FHbF is adjusted with the pH sensitivity to a nominal

pH = 7.4. For further details please refer to the Interference Tests section
T T
for oximetry parameters.

b. Specifications for imprecision are derived from worst-case values found
during internal laboratory tests. 40 % relative is then added as a safety
factor.
5-69
Performance test results bilirubin
Reference The standard bilirubin solution is traceable to Bechman C20 Standard Reference
method Material.
As the optical system is unchanged in the ABL8x7 FLEX analyzers compared to
the ABL700 Series, the specifications for bilirubin have not been re-established
see the description of bilirubin in section ABL8x0/8x5 Performance characteristics
T T
earlier in this chapter.
ctBil
T T S250 mode bias:
ctBil (mol/L) ctHb (g/dL) Bias
0 Plasma 0.7
0 15 6.6
0 20 9.9
400 Plasma 5.0
400 15 7.0
400 20 8.1

ctBil ctHb S0
B B SD
B B SABL
B B SXB B
(mol/L) (g/dL)
0 Plasma 1.1 2.3 3.4 6.0
0 15 3.0 2.9 5.7 9.9
0 20 4.0 5.5 9.4 17.5
400 Plasma 2.5 2.5 11.6 16.0
400 15 6.0 5.0 14.6 21.7
400 20 9.0 10.0 17.7 29.2
Notes a, b, c.
5-70
ctBil (continued) C125 mode bias:

T T T T
ctBil (mol/L) ctHb (g/dL) Bias

0 Plasma 0.1
0 15 1.6
0 20 2.7
400 Plasma 10.2
400 15 0.4
400 20 2.2

ctBil ctHb S0
B B SD
B B SABL
B B SXB B
(mol/L) (g/dL)
0 Plasma 1.1 2.3 3.4 6.0
0 15 3.0 2.9 5.8 9.9
0 20 4.0 3.0 11.3 17.5
400 Plasma 5.0 2.5 11.6 19.0
400 15 9.0 5.0 14.6 22.3
400 20 11.0 6.5 19.6 33.9
Notes a, b, c.
NOTES:
a. Adult/fetal blood, pH = 7.4 0.1, normal MCHC and albumin variation.

Spiked with unconjugated bilirubin.
b. ctBil specification at level 200 mol/L is interpolated from the measured
T T
specifications at 0 and 400 mol/L.

c. The performance specifications apply to measurements performed using
CLINITUBES capillary tubes with clot catchers and mixing wire from
Radiometer.
5-71
Performance test conditions and results cCrea T T
Introduction This section describes performance characteristics for the cCrea parameter and
T T
includes the following topics:

Definitions
Samples
Test conditions
Performance whole blood samples
Performance plasma samples
Performance quality control
Performance NIST909b standards
Effect of Hct concentration
Linearity ABL837 FLEX analyzer versus HPLC reference method
Detection limit
Comparison study (serum) enzymatic method
Comparison study (serum) Jaff method
Comparison study whole blood
Imprecisions for the macro- and micromodes
Definitions The following terms are used to describe the performance specifications of the
ABL8x7 FLEX analyzers:
Term Definition
Repeatability The term "within-run imprecision" is identical to the ISO term
(within-run "repeatability", i.e. the closeness of the agreement between
precision) results of successive measurements of the same measurand
carried out under the same conditions of measurement [11].
Reproducibili- The ISO term "reproducibility" describes the closeness of
ty (total agreement of results of measurements under changed
imprecision) conditions. Reproducibility may include the following:
within-run imprecision, run-to-run imprecision, day-to-
day imprecision or/and "Instrument-to-instrument
imprecision" [11].
Sy/x
B B Standard Deviation about regression line
X Mean value
R Correlation coefficient (used in the second power: R2) P P
N number of measurements on several analyzers used for the test
5-72
Performance test conditions and results cCrea, Continued T T T T
Samples
Preparation: Different experiments were made in order to investigate the
cCrea performance on the ABL837 FLEX analyzer under
different conditions.
The concentration of creatinine in the samples was reached by
spiking with a stock solution.
The samples used in these experiments were serum/plasma,
whole-blood or aqueous samples. Aqueous and serum/plasma
samples were spiked directly. Whole-blood samples were
prepared by separating the erythrocyte and plasma/serum layer.
The plasma/serum layer was then spiked and afterwards mixed
with erythrocyte layer. In order to reach different hematocrit
concentrations in the samples, different volumes of
plasma/serum and erythrocyte layer were mixed. Equilibrium
in the whole-blood samples was reached by gently mixing the
samples for 2 hours at room temperature.
The whole blood samples were prepared the day of the analysis
and not stored.
Storage of In order to prevent creatinine creatine equilibrium in the
serum/plasma serum/plasma samples, they were stored in the freezer at either
samples: 20 C or 80 C.
Performance Materials and methods:

TU UT
whole blood
The performance on whole-blood samples was tested during three days. Five
samples
whole-blood samples with different creatinine concentrations were prepared every
day. Each sample was measured five times in succession on nine ABL837 FLEX
analyzers see the table below.
Day cCrea(ABL837)
T T Repeatability Reproducibility* N
(mol/L) (CV%) (CV%)
1 87 1.3 3.6 45
1 320 1.4 2.5 45
1 566 1.2 2.5 45
1 1090 1.1 2.9 45
1 1575 1.0 3.3 45
2 55 1.1 4.6 45
2 252 1.0 2.5 45
2 538 1.1 2.7 45
2 1059 1.4 2.8 45
2 1575 1.4 3.4 45
3 59 1.5 3.7 45
5-73
Performance test conditions and results cCrea, Continued T T
Performance
whole blood Day cCrea(ABL837)
samples (mol/L) (CV%) (CV%)
(continued)
T
3 267 1.5 2.8 45
3 543 1.4 3.0 45
3 1046 1.1 3.0 45
3 1548 1.4 3.1 45
* Reproducibility includes within-run and instrument-to-instrument imprecisions.

TU
plasma samples
The precision performance on plasma samples was tested following the guidelines
described in CLSI EP5-A [13]. The performance was evaluated during 20 test days
where two separate runs (run = double determination) were performed each day on
three different plasma samples with normal, medium and high concentration of
creatinine, respectively. The study was performed on two ABL837 FLEX
Analyzer cCrea(ABL837)
(mol/L) (CV%) (CV%)
1 63 0.8 2.2 80
1 241 0.9 1.9 80
1 568 0.6 2.2 80
2 64 0.9 1.9 80
2 244 1.1 1.9 80
2 574 0.8 2.2 80
* Reproducibility includes within-run, run-to-run and day-to-day imprecisions.

TU
quality control
The precision performance on S7835, S7845 and S7855 AutoCheck6+ solutions
was tested during a period of 24 days see the table below.
cCrea(ABL837)
T T Repeatability (CV%) Reproducibility* (CV%) N
(mol/L)
238 1.4 2.5 490
30 1.8 3.1 494
460 1.1 2.3 486
* Reproducibility includes within-run, run-to-run, day-to-day and instrument-to-
instrument imprecisions.
5-74

TU
NIST 909b
Bias against the NIST 909b was determined as follows: two levels of NIST 909b
standards
were tested during one day in order to check the bias of the creatinine parameter.
The two levels of NIST 909b were prepared according to the recommended
procedure; each level was measured twice on 10 ABL837 FLEX analyzers see
the table below.
NIST 909b cCrea(ABL8x7)
T T Bias Repeatability Reproducibility* N
(mol/L) (mol/L) (%) (CV%) (CV%)
56.18 0.55 57.3 2.1 0.3 1.4 20
467.4 5.3 470.7 0.7 0.8 1.3 20
* Reproducibility includes within-run and instrument-to-instrument imprecisions.
Linearity The creatinine measurement on the ABL837 FLEX analyzer in whole blood has
been standardized towards serum/plasma creatinine because it is an established
international point of reference for predicate laboratory measurements of creatinine
in the clinical setting.
This has been done in two steps:
The relation between the used reference method, HPLC, and the ABL837 FLEX
analyzer has been established on both serum and plasma samples.
The relation between plasma and whole blood samples has been established on
the ABL837 FLEX analyzer.
Traceability between whole-blood measurements on the ABL837 FLEX analyzer
and serum/plasma measurements on the HPLC reference method has thereby been
established.
Linearity The primary working standards are prepared from NIST SRM 914a (creatinine)
reference and used to determine the creatinine concentration of seven serum pool standards
method and seven plasma standards. The measurements are performed using Reversed
Phase HPLC (High Performance Liquid Chromatography). The method has been
validated, using NIST SRM 909b (human serum).
Linearity Materials and methods:

TU UT
serum samples
A serum pool was dialyzed in order to remove all creatinine and creatine, and
seven serum pool levels with different creatinine concentrations (25 to 1900
mol/L) and zero creatine were prepared. The seven serum pools were measured
on an HPLC reference method [12] and the mean values of the HPLC method were
used to assign reference values to seven serum pool levels. The linear response of
the cCrea(ABL8x7) was studied by performing measurements on the seven serum
T T
pool levels during three days. Three measurements were made on each level every
day on nine ABL837 FLEX analyzers. A total of 535 measurements were made.
5-75
Linearity The cCrea results from the HPLC reference method and the ABL837 FLEX
T T
serum samples analyzer show linear relationship.

(continued)
T
Regression Plot
cCrea(ABL837)
T T
(mol/L)
cCrea(HPLC) (mol/L)
T T
The equation is as follows:

cCrea(ABL8x7) = 0.993 cCrea(HPLC) 0.5
T T T T
2
where Sy/x = 22.4 mol/L, R = 0.999, N = 535
B B P P
The Bias % Plot shows comparison of ABL837 and HPLC cCrea measurements. T T
cCrea(ABL8x7) cCrea(HPLC)
Bias = 100 (%)
cCrea(HPLC)
5-76
Linearity Bias % Plot

serum samples
(continued)
T T
Bias (%)
95 %
prediction
limits
cCrea(HPLC) (mol/L)
T T

TU UT
plasma samples
A plasma pool was dialyzed in order to remove all creatinine and creatine, and
seven plasma pool levels with different creatinine concentrations (25 to 2000
mol/L) and zero creatine were prepared. The seven plasma pools were measured
on an HPLC reference method [12] and the mean values of the HPLC method were
used to assign reference values to seven plasma pool levels. The linear response of
the cCrea(ABL8x7) was studied by performing measurements on the seven plasma
T T
pool levels. Three measurements were made on each level on nine ABL837 FLEX
analyzers. A total of 184 measurements were made.
The cCrea results from the HPLC reference method and the ABL837 FLEX
T T
analyzer (see regression plot on the next page) show linear relationship.
5-77
Linearity Regression Plot

plasma samples
(continued)
T
cCrea(ABL837)
T T
(mol/L)
cCrea(HPLC) (mol/L)
T T

cCrea(ABL8x7) = 0.977 cCrea(HPLC) + 1.7
T T T T
2
where Sy/x = 16.6 mol/L, R = 0.999, N = 184
B B P P
The Bias % Plot shows comparison of ABL837 and HPLC cCrea measurements.T T
cCrea(ABL8x7) cCrea(HPLC)
Bias = 100 (%)
cCrea(HPLC)

TU
5-78
Linearity Bias % Plot

T
plasma samples
(continued)
T T
Bias (%)
95 %
prediction
limits
cCrea(HPLC) (mol/L)
T T

U
whole blood
Whole-blood samples with different creatinine concentrations in the range of 41 to
versus plasma
1852mol/L were used. Each sample was measured as duplicate or triplicate on
ABL837 FLEX analyzers. The samples were then centrifuged. The plasma samples
thus obtained were also measured as duplicates or triplicates on the same ABL837
FLEX analyzers. This experiment was performed both internally at Radiometer
and externally at a hospital on patient samples.
Correlation between whole blood and plasma measurements on the ABL837 FLEX
analyzer is shown on the regression plot.
5-79
Linearity Regression Plot

whole blood
versus plasma
cCrea(ABL837,
(continued)
T T
T T
plasma), mol/L
cCrea(ABL837, whole blood), mol/L

T T
The plot shows a small difference between results on whole blood and plasma
(linear relationship).
The ABL8x7 FLEX analyzers are designed to measure cCrea on whole blood. If
plasma, serum or NIST SRM is to be measured on the ABL8x7 FLEX analyzers,
cCrea can be corrected as follows:
cCrea(ABL8x7,plasma/serum) mol/L = 0.950 cCrea(ABL8x7,whole
T T T T
blood) 0.4
cCrea(ABL8x7,plasma/serum) mg/dL = 0.950 cCrea(ABL8x7,whole
T T T T
blood) 0.005
where cCrea(ABL8x7,whole blood) are the results obtained on the analyzer.
T T
Creatinine Materials and methods:

U U
linearity at
Seven levels of creatinine serum pool were prepared in order to test the effect of
various creatine
creatine concentrations on the linearity of the cCrea(ABL8x7).
concentrations
T T
For each creatinine level three samples with 0, 100 and 250 mol/L creatine,
respectively, were prepared by spiking. The samples without creatine were
prepared in order to obtain reference values (the same volume was added to these
samples as for the 100 and 250 mol/L creatine samples).
Each sample (three creatine levels and seven creatinine levels; 21 samples in total)
was measured three times on eight ABL837 FLEX analyzers every day over three
days. A total of 72 measurements were made on each sample.
5-80
Creatinine The cCrea (ABL837) results on samples with 100 mol/L creatine show linear
linearity at relationship.
various creatine
Regression Plot
concentrations
(continued)
T T
Assigned mean value for cCrea(ABL837) (mol/L)

T T

cCrea(100 mol/L creatine) = 1.000 cCrea(0 mol/L creatine) 3.2
T T T T
2
where Sy/x = 35.6 mol/L, R = 0.999, N = 492
B B P P
The cCrea(ABL837) results on samples with 250 mol/L creatine show linear
relationship (see the next page):
5-81
Creatinine Regression Plot

linearity at
various creatine
concentrations
(continued)
T T
Assigned mean value for cCrea(ABL837) (mol/L)

T T

cCrea(250 mol/L creatine) = 0.993 cCrea(0 mol/L creatine) + 0.9
T T T T
2
where Sy/x = 35.6 mol/L, R = 0.999, N = 492
B B P P
Effect of Hct Materials and methods:

U U
concentration
Five samples with different hematocrit concentrations in the range of 20 to 70 %
were prepared. Each sample was measured three times on 10 ABL837 FLEX
Hct (%) cCrea(ABL837)

T T
cCrea
T T
N
(mol/L) (mol/L)*
24 66 3 30
31 65 2 30
46 63 0 30
57 62 1 30
69 59 4 30
* cCrea = cCrea (Hct) cCrea (Hct = 46 %)

T T T T T T
5-82
Detection limit Materials and methods:

U
The detection limit of the cCrea(ABL8x7) parameter was determined following the
T T
guidelines in CLSI EP17-A [14].

Limit of Blank (LoB): In order to determine LoB, three samples with cCrea = 0 T T
mol/L and creatine concentrations of 0, 50 and 125 mol/L were prepared. The
samples were then measured on seven ABL837 FLEX analyzers over two days.
Limit of Blank (LoB) was determined, using the following equation:
LoB = mean + 1.645 Standard Deviation at cCrea = 0 mol/L T T
Limit of Detection (LoD): The same procedure was followed to determine LoD
on samples with cCrea = 10 mol/L at 0, 50 and 125 mol/L creatine
T T
concentrations. Limit of Detection (LoD) was determined, using the following

equation:
LoD = LoB + 1.645 Standard Deviation at cCrea = 10 mol/L. T T
LoB N LoD N
(mol/L creatinine) (mol/L creatinine)
3.2 70 5.3 70
The LoD of the cCrea was found to be 5.3 mol/L on the ABL837 FLEX analyzer.
Limit of Quantitation (LoQ): To determine LoQ, samples with cCrea = T T
25mol/L and creatine concentrations at 0, 50 and 125 mol/L were measured in

order to compare the total error of cCreaABL837 at 10 and 25 mol/L creatinine.
T T B B
The LoQ (Limit of Quantitation) is the lowest actual amount of creatinine that can
be reliably detected (the LoD) and at which the total error meets the requirements
(acceptable for clinical use). So if the total error of the measurement used in the
LoD study is acceptable, then LoQ = LoD.
The total analytical error is determined using the following equation:
Total Error = (|Bias| + 2 Standard Deviation)
The table below shows the cCrea(ABL8x7) results for samples with creatinine at
T T
10 and 25 mol/L:
Level Bias SD Total Error N
(mol/L) (mol/L) (mol/L) (mol/L)
10 1.7 1.3 4.4 70
25 1.7 1.5 4.7 67
5-83
Detection limit The total Error of cCrea measurements on the ABL837 FLEX analyzer for the
(continued)
T T
LoD study (cCrea = 10 mol/L) is acceptable for clinical use and the limit of
T T
Quantitation therefore equals the Limit of Detection:

LoQ (cCrea(ABL8x7)) = LoD (cCrea(ABL8x7)) = 5.3 mol/L creatinine
T T T T
The lower detection limit of the ABL8x7 FLEX analyzer was set at 10 mol/L
creatinine; the values lower than 10mol/L will not be reported by the analyzer.
Comparison Materials and methods:

U U
study (serum) In order to compare repeatability and bias of the cCrea(ABL8x7) parameter with
T T
enzymatic an enzymatic laboratory routine method, the guideline CLSI EP9-A [15] was
method followed.
In the study performed at a university hospital in Denmark, the enzymatic method
of COBAS Integra 700 from Roche (called Integra for short) was used as the
comparative method. 104 patient (serum) samples (CLSI recommends a minimum
of 40 samples) in a clinically significant range of 15-1263 mol/L were collected.
The samples were measured twice by both methods.
From duplicate 104 patient samples covering the range 15-1263 mol/L creatinine,
statistical calculation of repeatability was made for the Integra and the ABL837
FLEX analyzer:
Method Repeatability (CV%) N (number of duplicates)
Integra 1.5 104
ABL837 2.8 104
Standard Deviation 100

CV % =
X
where
N
(meas1 - meas2) 2
Standard Deviation = 1
2N
where meas1 and meas2 are two measurements on the same sample, i.e. duplicates.
The regression plot (see the next page) describes the relationship between
cCrea(ABL8x7) and cCrea(Integra).
T T T T
5-84
Comparison Regression Plot

study (serum)
enzymatic cCrea(ABL837)
T T
method (mol/L)
(continued)
T T
cCrea(Integra) (mol/L)
T T
The relationship between cCrea(ABL8x7) and cCrea(Integra) is as follows:

T T T T
cCrea(ABL8x7) = 1.014 cCrea(Integra) + 1.8

T T T T
where Sy/x = 13.4 mol/L, R2 = 0.999, N = 208

B B P P
The Bias % Plot (see the next page) shows comparison of the cCrea(ABL8x7) and T T
cCrea(Integra).
T T
cCrea(ABL8x7) cCrea(Integra)
Bias = 100 (%)
Mean (cCrea(ABL8x7) + cCrea(Integra) )
5-85
Comparison Bias % Plot

study (serum)
enzymatic Bias (%)
method
(continued)
T T
95 %
prediction
limits
Mean (cCrea(ABL8x7) + cCrea(Integra)) (mol/L)

T T T T
Note that the results outside the prediction limits in the low concentration range
correspond to cCrea values of 20-30 mol/L.
T T

U
study (serum) In order to compare repeatability and bias of the cCrea (ABL8x7) parameter with a
T T
Jaff method Jaff laboratory routine method, the guideline CLSI EP9-A [15] was followed.
In the study performed at a university hospital in Denmark, the Jaff-rate blank
method of Modular from Roche (Hitachi instrument with Boehringer Manheim kit)
called Modular for short was used as the comparative method. 54 patient
(serum) samples (CLSI recommends a minimum of 40 samples) in a clinically
significant range of 21-1263 mol/L creatinine were collected. The samples were
measured twice by both methods.
From duplicate 54 patient samples covering the range 21-1263 mol/L creatinine,
statistical calculation of repeatability was calculated for the Modular and the
ABL837 FLEX analyzer:
Modular 1.4 54
ABL837 2.5 54
5-86
Comparison Standard Deviation 100

study (serum) CV % =
X
Jaff method
(continued)
T T
where
N
(meas1 - meas2) 2
2N
where meas1 and meas2 are measurements on the same sample, i.e. duplicates.
The Regression Plot below describes the relationship between cCrea(ABL8x7) and
T T
cCrea(Modular).
T T
Regression Plot
T cCrea(ABL837)
T
(mol/L)
cCrea(Modular) (mol/L)
T T
5-87
Comparison The relationship between cCrea(ABL8x7) and cCrea(Modular) is as follows:

T T T T B B
study (serum)
cCrea(ABL8x7) = 1.154 cCrea(Modular) 33.2
Jaff method
T T T T
(continued)
T T where Sy/x = 15.8 mol/L, R2 = 0.999, N = 108
B B P P
The Bias % Plot below shows comparison of the cCrea(ABL8x7) and T T
cCrea(Modular).
T T
cCrea(ABL8x7) cCrea(Modular)
Bias = 100 (%)
Mean (cCrea(ABL8x7) + cCrea(Modular))
Bias % Plot
Bias (%)
95 %
prediction
limits
Mean (cCrea(ABL8x7) + cCrea(Modular)) (mol/L)

T T T T

U U
study whole In order to compare repeatability and bias of the cCrea(ABL8x7) parameter with a T T
blood whole blood creatinine method, the guideline CLSI EP9-A [15] was followed.
In the study performed at a hospital in the USA, the i-STAT creatinine cartridges
were used as the comparative method. 55 patient (heparinized whole blood)
samples (CLSI recommends a minimum of 40 samples) in a clinically significant
range of 44-1743 mol/L were collected. The samples were measured twice by
both methods.
5-88
Comparison From duplicate 55 patient samples covering the range 44-1743 mol/L creatinine,
study whole statistical calculation of repeatability was calculated for the i-STAT and the
blood ABL837 FLEX analyzer:
(continued)
T

i-STAT 3.3 55
ABL837 2.1 55
Standard Deviation 100

CV % =
X
where
N
(meas1 - meas2) 2
2N
where meas1 and meas2 are measurements on the same sample, i.e. duplicates.
The Regression Plot below describes the relationship between cCrea(ABL8x7) and
T T
cCrea(i-STAT).
T T
Regression Plot
cCrea(ABL837)
T T
(mol/L)
cCrea(i-STAT) (mol/L)
T T
5-89
Comparison The relationship between cCrea(ABL8x7) and cCrea(i-STAT) is as follows:

T T T T B B
study whole
cCrea(ABL8x7) = 0.990 cCrea(i-STAT) 18.5
blood
T T T T
(continued)
T T where Sy/x = 38.2 mol/L, R2 = 0.997, N = 110
B B P P
The Bias % Plot below shows comparison of the cCrea(ABL8x7) and cCrea(i- T T T T
STAT).
cCrea(ABL8x7) cCrea(i - STAT)
Bias = 100 (%)
Mean (cCrea(ABL8x7) + cCrea(i - STAT) )
Bias % Plot
Bias (%)
95 %
prediction
limits
Mean (cCrea(ABL8x7) + cCrea(i-STAT)) (mol/L)

T T T T
Imprecision Test conditions were as follows:
Item Description
Primary reference Reverse Phase HPLC
method
Analyzers and test 10 ABL837 were tested over three days in the following
modes modes:
syringe S250
capillary C125
5-90
Imprecision
(continued)
T
Item Description
Blood samples Heparinized blood from healthy voluntary donors.
Five blood pools were prepared to cover the test range.
Blood The measurements were performed by different operators
measurements
Calibration All calibration solutions and gases used for the tests are
solution and gases traceable to Primary Reference Standards.
Traceability certificates for the ABL800 FLEX calibration
solutions and gases are found at the end of chapter 7:
Solutions.
T T

conditions
S250 mode:
cCrea (mol/L) S0B B SDB B SABL
B B SX
B B
60 1.0 0.9 2.8 3.9

250 3.6 3.8 11 15
500 7.1 7.5 21 29
1000 14 15 43 59
1500 21 23 64 88
C125 mode:
cCrea (mol/L) S0B B SDB B SABL
B B SX
B B
60 1.7 1.5 3.0 4.7

250 7.0 6.2 11 18
500 14 13 23 36
1000 28 25 45 73
1500 42 38 68 109
5-91
Interference tests
pH/blood gas The following interference results are found for the pH and blood gas electrodes:
Substance Test conc. Interference on pO2 electrode B B
Halothane 3% 5 % increased sensitivity
Intralipid* (20 % solution) in a concentration less than 4 % (the final Intralipid

level being 0.8 %) will not interfere on pH measurements.
If intralipid is found in higher concentrations it will interfere on the measurements,
see table below:
*Intralipid (Kabivitrum Inc., California and Stockholm) is a brand name for an aqueous suspension of lipid
droplets that is sterile and suitable for intravenous feeding of patients
Final level of intralipid Interference on pH measurements

0.8 % 0%
1.2 % 1.4 %
1.6 % 2.6 %
Electrolytes The following interference results are found for the electrolyte electrodes:
Interference on
Substance Test conc. cK+
T T P P cNa+
T T P P cCa2+
T T P P
cCl
T T P P
(4 mmol/L (150 mmol/L (1.25 mmol/L (110 mmol/L

level) level) level) level)
Li+ P P 4 mmol/L 0 0 0
K+ P P 12 mmol/L 1 0.01
Na+ P P 100-180 0.1 to 0.1
mmol/L
NH4+ B PB P 1 mmol/L 0 0
Ca2+ P P 5 mmol/L 0
Mg2+ P P 5 mmol/L 0 0 0.05
Br P P 10 mmol/L 41
F P P 1 mmol/L 0
I
P P 3.0 mmol/L 30-90
ClO4 B PB P 1.5 mmol/L 8-30
HCO3 B PB P 25-50 mmol/L 0.1 mmol/L Cl P P
per mmol/L
HCO3 B PB P
Lactate 10 mmol/L 0
5-92
Interference tests, Continued T T
Electrolytes T
(continued)T
Interference on
Substance Test conc. cK+
T T P P cNa+
T T P P cCa2+
T T P P
cCl
T T P P
(4 mmol/L (150 mmol/L (1.25 mmol/L (110 mmol/L

level) level) level) level)
Acetyl- 3.0 2
salicylic mmol/L
acid
Salicylic 4.0 7
acid mmol/L
Ascorbic 1.0 0
acid mmol/L
pH 7.2 7.2 0 0 0.01 1
pH 7.6 7.6 0 0 0.01 1
Sulphide will give erroneously high cCl results. T T P P
Glucose and The following interference results are found for the Glucose and Lactate
Lactate electrodes:
Interference on
Substance Test conc. cGlucose
T T TcLactate
T
(mmol/L) (4.0 mmol/L level) (1.5 mmol/L level)
Acetoacetic acid 2 <0.1 <0.1

Acetylsalicylic acid 3 <0.1 <0.1
Ascorbic acid 2 <0.1 <0.1
Bilirubin (conjugated) 0.46 <0.1 <0.1
Bilirubin (unconjugated) 0.34 <0.1 <0.1
Chlorpromazine HCl 0.2 <0.1 <0.1
Citrate 50 0.37 0.19
Creatinine 3 <0.1 <0.1
D-glucose 67 <0.1
Dopamine HCl 1.0 <0.1 <0.1
EDTA 3 <0.1 <0.1
Ethanol 79 <0.1 <0.1
Fluoride 50 0.36 <0.1
5-93
Glucose and
LactateT
Interference on
(continued)T
Substance Test conc. cGlucose T T cLactate
T T
(mmol/L) (4.0 mmol/L level) (1.5 mmol/L level)
Galactose 3.3 up to 1.88*

Glucosamine 2 up to 1.06*
Glycolic acid 1 <0.1 Interference
Heparin 8000 IU/dL <0.1 <0.1
Ibuprofen 2 <0.1 <0.1
Lactic acid 12 <0.1
Maltose 5 up to 0.4*
Mannose 1 up to 0.4*
Oxalate 90 0.47 0.14
Paracetamol-4- 2 <0.1 <0.1
acetamidophenol
Pralidoxime 0.045 <0.1 <0.1
Pyruvate 2 <0.1 <0.1
Salicylic acid 4 <0.1 <0.1
Thiocyanic acid 24 Interference Interference
Urea 84 <0.1 <0.1
Uric acid 1.5 <0.1 <0.1
Xylose 1 up to 0.34*
* Values determined at cGlu = 0 mmol/L. Interference at cGlu 4.0 mmol/L is

expected to be the same.
cLactate % at :
T T
Hematocrit % 5 mmol/L level 15 mmol/L level

0 0.7 % 0.7 %
45 0.0 % 0.0 %
60 0.5 % 2.0 %
75 2.2 % 5.0 %
5-94
Oximetry The substances against which the oximetry parameters (ctHb, sO2, FO2Hb, T T B B B B
parameters FCOHb, FMetHb, FHHb, FHbF) and ctBil were tested for interference are given T T
in the table below:

(SAT100 blood reference test sample: ctHb = 15 g/dL, sO2 = 100 %, FCOHb = 0.7 B B
%, FMetHb = 0.5 %, ctBil = 0, pH = 7.4. Parameter sensitivity from the influence

on the absorbance spectrum from various substances.)
Change on
Substance Test conc. TctHb
T sO2
T T B B FO2Hb
T T B B FCOHb
T T FMetHb
T T FHHb
T T FHbF
T T T TctBil T T
(g/dL) (%) (%) (%) (%) (%) (%) T

(mol/L)
T T T
Intralipid 4 Vol % e) P P
0.5 0.1 1.3 0.5 0.9 0.1 11 0
b)
4 P P
f)
Intralipid 2 Vol % P P
0.4 0.1 0.3 0.3 0.1 0.1 11 7
2 b) P P
HbF a), c)
P P 20 % P P
0.02 1.17 0.04 0.73 0.37 1.14 0 14
SHb
T T 10 % 0 1.0 0.9 0.1 0.1 0.9 Not tested
pH 7.1 0.5 0.5 0.2 0.4 0.1 0.5 19 0
7.9 0.6 0.6 0.5 1.0 0.1 0.6 13 5
Cardio Green c) P P 5 mg/L 0.16 0.29 1.14 0.07 0.93 0.29 5 20
Evans Blue c) P P 5 mg/L 0.04 0.14 0.28 0.20 0.20 0.14 5 5
Betacarotene in 3.7 mol/L 0.0 0.02 0.03 0.01 0.04 0.02 0.1 0.2
c)
plasma P P
Patent Blue V c) P P 10 mg/L 0.16 0.39 0.86 0.47 0.00 0.38 21 38

c)
Methylene Blue P P 30 mg/L 0.7 3.4 5.6 3.0 6.2 3.6 37 25
HiCN c) P P
0.11 0.26 1.5 3.0 0.5 0.5 1.5 24 47
mmol/L
MCHC c), d) P P 320 g/L No interference 12
newborn range 350 g/L 17
Sedimentation rate 100 arb. 0.5 No interference Not
Units tested
Notes: a) If function "Correction for HbF" is not activated, the change is 0 for all parameters.
b) Plasma sample.
c) Calculated value from mathematical superposition of measured pure interference
spectrum on measured reference spectrum.
d) ctBil = 400 mol/L.
T T
e) Intralipid (20 % solution) at 4 Vol % gives final test level of 0.8 %.

f) Intralipid (20 % solution) at 2 Vol % gives final test level of 0.4 %.
There is no interference from fetal hemoglobin (HbF) when the analyzer applies HbF
correction. There is no interference from bilirubin (conjugated/unconjugated) up to
1000 mol/L.
5-95
Interference tests, Continued T
Contribution to The process of HbF correction introduces additional noise compared to measure-
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
from HbF to obtain the imprecision specifications for fetal samples (also for adult samples if
correction function Correction for HbF levels less than 20 % is activated).
S fetal = S adult
2
+ S HbF
2
; geometrical addition of imprecision
where Sfetal is the calculated fetal imprecision; Sadult is the corresponding adult
B B B B
imprecision; SHbF is the extra contribution from HbF correction which is listed in
B B
the following tables.

HbF correction contribution to 10 g/dL SAT100 fetal sample:
S0 B B SD
B B SABL
B B SX
B B
sO2 %
B B 0.15 0.20 0.19 0.31
FHHb % 0.14 0.19 0.19 0.30
FO2Hb %B B 0.01 0.01 0.01 0.01
FCOHb % 0.09 0.13 0.12 0.20
FMetHb % 0.05 0.06 0.06 0.10

S0 B B SD
B B SABL
B B SX
B B
sO2 %
B B 0.09 0.12 0.29 0.33
FHHb % 0.09 0.11 0.28 0.32
FO2Hb %B B 0.00 0.00 0.01 0.01
FCOHb % 0.06 0.07 0.18 0.21
FMetHb % 0.03 0.04 0.09 0.11

S0 B B SD
B B SABL
B B SX
B B
sO2 %
B B 0.09 0.12 0.20 0.25
FHHb % 0.09 0.11 0.19 0.25
FO2Hb %B B 0.00 0.00 0.01 0.01
FCOHb % 0.06 0.07 0.13 0.16
FMetHb % 0.03 0.04 0.06 0.08
5-96
FHbF sensitivity FHbF is sensitive to pH deviations from the nominal value of pH = 7.4. If pH is
for pH changes T T
converted into cH+ (hydrogen ion concentration), the relationship between the
T T P P
changes in cH+ and FHbF is linear as seen from the following equation:
T T P P
FHbF = 0.48 %/(nmol/L) (cH+ 40 nmol/L) T T P P
where pH = 7.4 corresponds to cH+ = 40 nmol/L. T T P P
EXAMPLE: pH = 7.25 corresponds to cH+ = 56 nmol/L. Then: T T P P
FHbF = 0.48 (56 40) = 7.7 %.
ctBil sensitivity
T T
MCHC (Mean Corpuscular Hemoglobin Concentration) is used to estimate
for MCHC hematocrit, Hct, which is used in the ctBil measurement. MCHC is an average Hb
T T
variations concentration in the red blood cell (RBC). If the RBC volume decreases, MCHC
increases. If an RBC has iron deficit, MCHC decreases.
Hct is determined from ctHb as follows:
ctHb
Hct =
MCHC
A standard value of 332 g/L is assumed for MCHC which gives
Hct = ctHb 0.0301 if the unit for ctHb is g/dL.
MCHC can, however, deviate from this standard value as illustrated in the
following table (see the next page).
Erythrocytometric values given for apparently healthy white and black subjects
of different ages are taken from: Geigy Scientific Tables, Physical Chemistry,
Composition of Blood, Hematology, Somametric Data, CIBA-GEIGY, 1984; 3,
207.
5-97
ctBil sensitivity
T T Subjects Age Hct Hct MCHC MCHC
for MCHC mean 95 % range mean, g/L 95 % range,
variations T
g/L
(continued) T
Men Adults 0.47 0.39-0.55 340 310-370

Women Adults 0.42 0.36-0.48 330 300-360
Boys Newborn 0.59 0.53-0.65 330 320-340
1 month 0.50 0.44-0.56 320 310-330
3 months 0.45 0.39-0.52 330 320-340
6 months 0.46 0.39-0.51 300 290-310
9 months 0.45 0.39-0.52 280 270-300
1 year 0.41 0.37-0.45 290 280-300
2 years 0.40 0.36-0.47 300 280-310
4 years 0.37 0.30-0.44 280 270-290
8 years 0.41 0.37-0.45 290 280-300
14 years 0.41 0.36-0.46 300 290-310
Girls Newborn 0.58 0.51-0.65 340 330-350
1 month 0.49 0.42-0.56 320 310-330
3 months 0.44 0.39-0.51 330 320-340
6 months 0.44 0.39-0.50 320 310-330
9 months 0.43 0.37-0.50 300 290-310
1 year 0.43 0.37-0.49 300 290-310
2 years 0.43 0.36-0.50 300 290-310
4 years 0.43 0.36-0.51 280 270-290
8 years 0.40 0.36-0.46 280 270-290
14 years 0.40 0.36-0.47 290 280-300
If MCHC is defined as MCHC = 332 g/L MCHC, then the contribution to the
relative error on the ctBil measurement is as follows:
T T
ctBil Hct MCHC

=
ctBil 1 Hct MCHC
A worst-case example, using 95 % confidence values:
A newborn girl with Hct = 0.58, MCHC = 350 g/L and ctBil = 400 mol/L. ctHb
may be derived as Hct MCHC = 0.58 x 350 g/L = 20.3 g/dL (reference range is
18.0 21.0 g/dL).
5-98
ctBil sensitivity ctBil 0.58 18

= = +0.071 And ctBil = 0.071 x 400 = 28 mol/L.
T T
for MCHC ctBil 1 0.58 350

T T
variations T
(continued) T
If the reference value for Hct is known, it is possible to correct the displayed ctBil T T
value, using the following equation:

1 ctHb(displayed) 0.0301
ctBil(corrected) = ctBil(displayed )
1 Hct(reference)
ctHb is measured in g/dL.
ctBil sensitivity
T T ctBil is slightly sensitive to pH deviations from the nominal value of pH = 7.4.
T T
for pH changes
The following table shows the changes in ctBil compared to the value at pH = T T
7.4.
Sample Type ctHb
T T
Nominal ctBil
T T ctBil
T T
g/dL ctBil
T T
(7.47.1) (7.47.9)
mol/L mol/L mol/L
Adult/fetal plasma 0 0 3 0
Adult blood, sO2 = 100 % B B 15 0 0 5
Fetal blood, sO2 = 100 % B B 15 0 13 4
Adult/fetal plasma spiked with 0 400 2 1
unconjugated bilirubin
Adult/fetal plasma spiked with 0 400 9 11
conjugated bilirubin
Adult blood spiked with un- 15 400 10 26
conjugated bilirubin, sO2 = 100 % B B
Fetal blood spiked with un- 15 400 4 16

conjugated bilirubin, sO2 = 100 % B B
Adult blood spiked with conjugated 15 400 14 35

bilirubin, sO2 = 100 %
B B
Fetal blood spiked with conjugated 15 400 0 26

bilirubin, sO2 = 100 %
B B
Creatinine Materials and methods:

U U
The interference testing of the cCrea(ABL8x7) parameter follows the guidelines

T T
described in CLSI EP7-A[16].

The interference test was performed on serum with normal creatinine concentration
in the range of 50 to 92 mol/L. A large serum pool was collected from a healthy
person not undergoing any medical treatment.
5-99
Creatinine Stock solutions of the tested interference were prepared in concentrations 20 times
(continued)
T T the test concentration on the day of the analysis.
Prior to measurement, one serum sample was spiked with the interference stock
solution (sample T) and another serum sample was spiked with the same volume of
the diluent used to prepare the stock solution (sample C).
The test of interferences was then performed as relative measurements. The sample
with the tested interference (T) was compared to the control sample (C) measured
at the same time: C1T1C2T2C3T3. Each sample was measured three times. The aim
B B B B B B B B B B B B
of the test has been to show interference above 8 mol/L.

The test was performed at a university hospital in Sweden.
The following substances have been tested on samples with cCrea in the range 50 T T
to 92 mol/L.
Substance Test concentration Interference (mol/L)

Ascorbic acid 227 mol/L < |8|
Acetoacetate 10 mmol/L < |8|
Acetone 10 mmol/L < |8|
Acetylsalicylic acid 3.3 mmol/L < |8|
Ammonia 1 mmol/L < |8|
Ampicillin 152 mol/L < |8|
Beta-hydroxybutyrate 10 mmol/L < |8|
Bilirubin 400 mol/L < |8|
Bleomycin sulfate 45 mg/L < |8|
Calcium chloride 3 mmol/L < |8|
Cephalexin 337 mol/L < |8|
Cephalothin 759 mol/L < |8|
Cephotaxime 671 mol/L < |8|
Cefoxitin 1.6 mmol/L < |8|
Chlorpromazine 6.3 mol/L < |8|
Creatine 200 mol/L < |8|
Citrate 50 mmol/L < |8|
Cyclosporin 12 mol/L < |8|
D(+)-Glucose 60 mmol/L < |8|
Dipyrone 50 mg/L < |8|
5-100
Creatinine
(continued)
T
Dobutamine 10 g/L < |8|
Dopamin 5.9 mol/L < |8|
Doxycycline 67.5 mol/L < |8|
Ethanol 86.8 mmol/L < |8|
Fluoride 50 mmol/L < |8|
Gentisic acid 117 mol/L < |8|
Glutamate sodium salt 2 g/L < |8|
Gluthation oxidized 10 mg/L < |8|
Gluthation reduced 10 mg/L < |8|
HCO3B PB P 40 mmol/L < |8|
Heparin (Li-salt) 80000 U/L < |8|
Hepes 20 mmol/L < |8|
Hemoglobin 10 % hemolysis < |8|
Hemoglobin 3.5 % hemolysis < |8|
Hydroxyurea 100 mol/L < |8|
Ibuprofen 2.4 mmol/L < |8|
Intralipid 5% < |8|
Intralipid 2.5 % < |8|
L-DOPA 20 mol/L < |8|
L(+)-Glucose 60 mmol/L < |8|
Lithium nitrate 3.2 mmol/L < |8|
L-Lactic acid 30 mmol/L < |8|
L-Prolin 250 mol/L < |8|
Lidocaine hydrochloride 100 mol/L < |8|
Lidocaine powder 98 % 100 mol/L < |8|
6-Mercaptopurine (13.1 mmol/L)* < |8|
Magnesium nitrate 3 mmol/L < |8|
Methotrexate 2.0 mmol/L < |8|
*Saturated stock solution
5-101
Creatinine
(continued)
T
Methyldopa 71 mol/L < |8|
Oxo-(2)-butyric acid 5 mmol/L < |8|
Paracetamol (acetaminophen) 1.7 mmol/L < |8|
pH 8.0 < |8|
pH 6.0 < |8|
Phenylbutazone 325 mol/L < |8|
Pyruvate 3 mmol/L < |8|
Rifampicin 78.1 mol/L < |8|
Sarcosine 1 mol/L < |8|
Sodium hydrogen carbonate 40 mmol/L < |8|
Sodium hydrogen phosphate 2 mmol/L < |8|
Theopyllin 222 mol/L < |8|
Theophyllin acetic acid 200 mol/L < |8|
Thiocyanate 24 mmol/L < |8|
Urea 50 mmol/L < |8|
Uric acid 3 mmol/L < |8|
5-102
References
List of 1. Kristensen HB, Salomon A, Kokholm G. International pH scales and

references certification of pH.
2. Definition of pH scales, standard reference values, measurement of pH and
related terminology (Recommendations 1994). Pure and Appl Chem 1985;
57, 3: 531-42.
3. Burnett RW, Covington AK, Maas AHJ, Mller-Plathe O et al. J Clin
T T
Chem Clin Biochem 1989; 27: 403-08.

4. IFCC reference methods and materials for measurement pH, gases and
electrolytes in blood. Scand J Clin Lab Invest 1993; 53, Suppl 214: 84-94.
5. Glucose. CLSI/NCCLS Publication RS1-A. Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087,
1989.
6. Reference and selected procedures for the quantitative determination of
hemoglobin in blood. Approved Standard (3rd edition), CLSI/NCCLS
Publication H15-2A. Clinical and Laboratory Standards Institute, 940
West Valley Road, Suite 1400, Wayne, PA 19087, 2000.
7. Evelyn K, Malloy H. Microdetermination of oxyhemoglobin,
methemoglobin and sulfhemoglobin in a single sample of blood.
Biological Chem 1938; 126: 655-62.
8. Kristoffersen K. An improved method for the estimation of small
quantities of alkali-resistant hemoglobin in blood. Scand J Clin Lab Invest
1961; 13: 402.
9. Quantitative measurement of fetal hemoglobin using the alkali
denaturation method. Approved Guideline. CLSI/NCCLS Publication
H13-A. Clinical and Laboratory Standards Institute, 940 West Valley
Road, Suite 1400, Wayne, PA 19087, 1989; 9, 18.
10. Begmeyer. Methods of enzymatic analysis. 3rd ed., Verlag Chemie
Deerfield Beach 1984; 6: 582-88.
11. VIM93: ISO, International Vocabulary of Basic and General Terms in
Metrology, Geneva: International Organization for Standardization; 1993.
12. Kristensen H.B. Traceability to the primary reference standards at
Radiometer. Copenhagen: Radiometer Medical ApS, 2004. Code 918-541.
13. CLSI Evaluation of Precision Performance of Clinical Chemistry Devices;
Approved Guidelines, EP5-A, Vol. 19, No. 2.
14. CLSI Protocols for Determination of Limits of Detection and Limits of
Quantitation; Approved Guidelines, EP17-A, Vol. 24, No. 34.
15. CLSI Method Comparison and Bias Estimation Using Patient Samples;
Approved Guideline Second Edition, EP9-A2, Vol. 22, No. 17.
16. CLSI approved guideline for interference testing in clinical chemistry,
EP7-A, Vol. 22, No. 27.
5-103
5-104
6. 6. Parameters
Overview
Introduction The measured, input and derived parameters are described in this chapter.

X X
Measured parameters ....................................................................................... 6-5

X X
Input parameters............................................................................................... 6-14

X X
Derived parameters .......................................................................................... 6-17

X X
Units of derived parameters ............................................................................. 6-22 X X
List of equations............................................................................................... 6-28

X X
Oxyhemoglobin dissociation curve (ODC)...................................................... 6-44 X X
Conversion of units .......................................................................................... 6-49

X X
Default values .................................................................................................. 6-51

X X
Altitude correction ........................................................................................... 6-52

X X
References ........................................................................................................ 6-53

X X
6-1
6. Parameters ABL800 FLEX reference manual
General information
The Deep The Deep Picture developed by Radiometer [1], (visit our website www.deep- H
Picture picture.com), expands traditional pH and blood gas analysis by evaluating the
H
capability of arterial blood to carry sufficient oxygen to tissues and to release it. It
simplifies interpretation by dividing the process into three stages:
Stage Description
Oxygen Oxygen uptake in the lungs indicates whether the pulmonary gas
uptake exchange is efficient enough to oxygenate arterial blood.
The uptake of oxygen in the lungs can be described by parameters
in combination, primarily the arterial oxygen tension (pO2(a)), B B
fraction of O2 in dry inspired air (FO2(I)) and shunt fraction of

B B B B

perfused blood (Qs/Qt) B B B B
However, other parameters may also be used, such as the

difference in alveolar air and arterial blood oxygen tension
(pO2(A-a)).
B B
Oxygen Oxygen transport reveals whether arterial blood contains sufficient

transport oxygen.
The oxygen concentration of arterial blood (ctO2(a)) also termed T T B B
oxygen content is determined by the concentration of total

hemoglobin (ctHb(a)), the fraction of oxygenated hemoglobin
(FO2Hb(a)) and the arterial oxygen tension (pO2(a)).
B B B B
Other parameters which should be known are the oxygen saturation

(sO2 (a)) and the fractions of dyshemoglobins (FCOHb(a) and
B B
FMetHb(a)).
Oxygen Oxygen release describes the ability of arterial blood to release
release oxygen to the tissues.
The release of oxygen from capillaries to tissues is determined by
the oxygen tension gradient between the two. This release of
oxygen is also influenced by the hemoglobin-oxygen affinity,
which is indicated by the oxygen tension at 50 % saturation, p50.
Symbols The symbols for the parameters are based on the principles described by Wandrup [2].
Each symbol consists of three parts, described below: T
1. Property
T T A symbol in italics p for pressure
T T
describing the quantity c for concentration

T T
F for fraction
T T
V for volume
T T
etc.
2. Component An abbreviation of the O2 for oxygen B B
component name CO2 for carbon dioxide B B
COHb for carboxyhemoglobin,

etc.
6-2
ABL800 FLEX reference manual 6. Parameters
Symbols
(continued) 3. (System) Specification of the system B for blood
P for plasma
T
a for arterial blood

v for mixed venous blood
A for alveolar air
T for patient temperature
T T
component
Example:
T
T pO2(a)
T B B
property system
The parameters are listed by symbol in three groups: measured, input and derived.
Ranges and The following ranges are used:

limits
Range
T T T Description T
Measuring The measuring range for a parameter is the range within which the
analyzer is physically capable of measuring. The measuring range
corresponds to the "range of indication" as defined in the
"International vocabulary of basic and general terms in metrology"
(VIM).
Reportable Is user-defined; is equal to or narrower than the measuring range.
Can be selected for all measured and derived parameters.
Reference "Reference ranges are valuable guidelines for the clinician, but they
should not be regarded as absolute indicators of health and disease.
Reference ranges should be used with caution since values for
healthy individuals often overlap significantly with values for
persons afflicted with disease. In addition, laboratory values may
vary significantly due to methodological differences and mode of
standardization" [10].
Ref. 10 has been the source for the reference ranges given in this
section. In some cases the values are taken from other sources
marked by their reference number.
When possible, the reference ranges for arterial blood have been
listed. Reference ranges must be used with caution as they depend on
a number of factors, such as sex, age and normal physiological
condition.
Critical limits are user-defined and can be entered into the analyzer software see
chapter 3: Setup Programs (section Analysis Setup) in the Operators Manual.
T T T T
6-3
Derived Derived parameters are calculated according to the equations stated.

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.
all values are known the derived parameter is designated calculated
T T
and a c is added to the result.

a default value is used the derived parameter is designated estimated
T T
and an e is added to the result.
If one or more default values have been used in the calculation, the result may
deviate significantly from the true value. The deviation on estimated oxygen status
parameters may become particularly significant if default values are used instead of
measured blood oximetry data.
In some cases, however, the default value is not accepted as the input for the
calculation. This is because the actual values of the missing parameter may deviate
significantly from the default value, thus making the estimation clinically
inappropriate. If sO2 cannot be measured due to severe errors, it will be calculated.
B B
Measured Some of the listed parameters are measured, depending on the analyzer
parameters configuration. In these cases the equation given only applies if that parameter is
not directly measured by the analyzer.
T T
Sample type Unless otherwise stated, a parameter will be calculated or estimated irrespective of
the choice on the Patient Identification screen: "Arterial", "Capillary", "Venous",
T T
"Mixed venous", or "Not specified". Some parameters, however, are defined for
arterial samples only; they will be calculated only for sample types entered as
"Arterial" or "Capillary".
The symbol for system (blood (B) or plasma (P)) is not stated in the equations
unless it is important for the calculation.
Units The units given for each parameter refer to the units available on the analyzer for that
parameter.
Default values The default values are listed in Default Values at the end of this chapter.
T T
6-4
Measured parameters
General The following is the used:

information
m= male
f= female
Reference for adult arterial blood
range
Reference [10] Tietz NW, Logan NM. Reference ranges. In: Tietz NW, ed.
Fundamentals of clinical chemistry. 3rd ed. Philadelphia: WB
Saunders Company 1987: 944-75.
(unless otherwise specified)
pH
Definition Indicates the acidity or alkalinity of the sample
Unit -
Measuring range 6.300-8.000
Reference range 7.35-7.45 (m, f)
cH+
Definition Concentration of hydrogen ions in blood
T T P P
Unit nmol/L
Measuring range 10.0-501
pCO2 B B Is used both for blood and expired air samples.

Definition Partial pressure (or tension) of carbon dioxide in
blood.
High and low pCO2 values of arterial blood
B B
indicate blood hypercapnia and hypocapnia,

respectively.
Unit mmHg; kPa; torr
6-5
Measured parameters, Continued T T
pCO2
Measuring range mmHg; torr: 5.0-250
T T B B
(continued)
T
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)
Conversion of units p (kPa) = 0.133322 p(mmHg) = 0133322
. p (torr)
p (mmHg) = p (torr) = 7.500638 p (kPa)
pO2 B B Is used for both blood and expired air samples.

Definition Partial pressure (or tension) of oxygen in blood.
High and low pO2 values of arterial blood indicate
B B
blood hyperoxia and hypoxia, respectively.

Measuring range mmHg; torr: 0.0-800
kPa: 0.00-107
Reference range mmHg: 83-108 (m, f)
kPa: 11.07-14.40 (m, f)
. p (torr)
p (mmHg) = p (torr) = 7.500638 p (kPa)
Baro
T Definition Ambient barometric pressure (p(amb))
T T

Measuring range mmHg; torr: 450-800
kPa: 60.0-106.7
Reference range -
. p (torr)
p (mmHg) = p (torr) = 7.500638 p (kPa)
6-6
ctHb Definition Concentration of total hemoglobin in blood.

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); 12.0-16.0 (f)
g/L: 135-175 (m); 120-160 (f)
mmol/L: 8.4-10.9 (m); 7.4-9.9 (f)
Conversion of units ctHb (g/dL) = 1.61140 ctHb (mmol/L);
T T
ctHb (g/L) = 16.1140 ctHb (mmol/L);

ctHb (mmol/L) = 0.62058 ctHb (g/dL) =
0.062058 ctHb (g/L)
Default value 9.3087 mmol/L, (15.0 g/dL or 150 g/L)
sO2
B B Can also be calculated.
Definition Oxygen saturation, the ratio between the concentrations
of oxyhemoglobin and the hemoglobin minus the
dyshemoglobins
Unit %; fraction
Measuring range %: 0.0-100.0
Fraction: 0.000-1.000
Reference range %: 95-99 (m, f)
Fraction: 0.95-0.99 (m, f)
6-7
sO2 (continued)
Reference Siggaard-Andersen O, Wimberley PD, Fogh-Andersen
T T B B T
N, Gthgen 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.
Available as AS106.
Equation The ODC is determined as described in equation for
Oxyhemoglobin Dissociation Curve (points I and III).
T T
S (1 FMetHb) FCOHb
sO 2 =
1 - FCOHb - FMetHb
where
S = ODC(P,A,T) T T
pO 2 FCOHb
P = pO 2 +
sO 2 (1 FCOHb FMetHb)
A=a
T = 37.0 oC
T T P P
FO2Hb B B Can also be calculated.

Definition Fraction of oxyhemoglobin in total hemoglobin in
blood
Unit %; fraction
Fraction: 0.000-1.000
Reference range %: 94-98 (m, f)
Fraction: 0.94-0.98 (m, f)
Equation FO 2 Hb = sO 2 (1 FCOHb FMetHb)
If sO2 is not measured, it will be calculated.
T T B B
If dyshemoglobins (FCOHb, FMetHb) are not known,

they are set to the default values.
6-8
FCOHb Definition Fraction of carboxyhemoglobin in total hemoglobin in

blood
Unit %; fraction
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 %)
FMetHb Definition Fraction of methemoglobin in total hemoglobin in

blood
Unit %; fraction
Fraction: 0.000-1.000
Reference range %: 0.0-1.5 (m, f)
Fraction: 0.000-0.015 (m, f)
Default value 0.004 (0.4 %)
FHHb Can also be calculated.

Definition Fraction of deoxyhemoglobin in total hemoglobin in
blood
Deoxyhemoglobin is the part of total hemoglobin which
can bind oxygen forming oxyhemoglobin. It is also
termed reduced hemoglobin, RHb.
Unit %; fraction
Fraction: 0.000-1.000
6-9
FHHb
Equation FHHb = 1 sO2 (1FCOHbFMetHb)FCOHb
T T
(continued) B B
FMetHb
T
If sO2 is not measured, it will be calculated from

T T B B
equation 39.
If dyshemoglobins (FCOHb, FMetHb) are not known,
they are set to the default values.
FHbF Definition Fraction of fetal hemoglobin in total hemoglobin in

blood
Unit %; fraction
Measuring range %: 0-100
Fraction: 0.00-1.00
Reference range %: 80 (m, f)
(neonates)
Fraction: 0.80 (m, f)
cK+
T T P P Definition Concentration of potassium ions in plasma
Unit mmol/L; meq/L
Measuring range mmol/L; meq/L: 0.5-25.0
Reference range m, f: 3.4-4.5 mmol/L
Conversion of units mmol/L = meq/L
T cNa+T P P Definition Concentration of sodium ions in plasma

Unit mmol/L; meq/L
Measuring range mmol/L; meq/L: 7-350
Reference range m, f; 136-146 mmol/L
6-10
cCa2+
T T P P Definition Concentration of calcium ions in plasma
Unit mmol/L; meq/L; mg/dL
Measuring range mmol/L: 0.20-9.99
meq/L: 0.40-19.98
mg/dL: 0.80-40.04
Reference range m, f: 1.15-1.29 mmol/L; 2.30-2.58 meq/L
Conversion of units meq/L = 2 mmol/L
mg/dL = 4.008 mmol/L
Reference Siggaard-Andersen O, Thode J, Wandrup JH. The
concentration of free calcium ions in the blood plasma
ionized calcium. 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.
cCl-T T Definition Concentration of chloride ions in plasma

Unit mmol/L; meq/L
Measuring range mmol/L; meq/L: 7-350
Reference range 98-106 mmol/L (m, f)
cGlu
T T Definition Concentration of D-glucose in plasma
Unit mmol/L; mg/dL
Measuring range mmol/L: 0.0-60
mg/dL: 0-1081
Reference range m, f: 3.89-5.83 mmol/L; 70-105 mg/dL
Conversion of units cGlucose (mg/dL) = 18.016 cGlucose (mmol/L)
T T T T
cGlucose (mmol/L) = 0.055506 cGlucose (mg/dL)

T T
6-11
cLac
T T Definition Concentration of L-lactate in plasma
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 cLactate (mmol/L)
T T
cLactate (mmol/L) = 0.11101 cLactate (mg/dL)

T T
(conversion based on the molecular weight of lactic

acid)
ctBil
T T Definition Concentration of total bilirubin in plasma
Total bilirubin includes its two forms: conjugated and
unconjugated.
Unit mol/L; mg/dL; mg/L
Measuring range mol/L: 0-1000
mg/dL: 0.0-58.5
mg/L: 0-585
Reference range See the table on the next page.
Conversion of units ctBil (mol/L) = 17.1 ctBil (mg/dL)
T T
ctBil (mol/L) = 1.71 ctBil (mg/L)

ctBil (mg/dL) = 0.0585 ctBil (mol/L)
ctBil (mg/L) = 0.585 ctBil (mol/L)
6-12
ctBil (continued) The reference ranges are as follows:

T T T T
Age ctBil
T T
24 hrs, premature 17-137 mol/L

1.0-8.0 mg/dL
10-80 mg/L
24 hrs, full-term 34-103 mol/L
2.0-6.0 mg/dL
20-60 mg/L
48 hrs, premature 103-205 mol/L
6-12 mg/dL
60-120 mg/L
48 hrs 103-171 mol/L
6-10 mg/dL
60-100 mg/L
3-5 days, premature 171-239 mol/L
10-14 mg/dL
100-140 mg/L
3-5 days, full-term 68-137 mol/L
4-8 mg/dL
40-80 mg/L
>1 month 3.4-17 mol/L
0.2-1.0 mg/dL
2-10 mg/L
T cCrea
T Definition Concentration of creatinine in blood
Unit mol/L; mg/dL
Measuring range mol/L: 10-1800
mg/dL: 0.11-20.4
Reference range m: 53-106 mol/L, 0.6-1.2 mg/dL
f: 44-97 mol/L, 0.5-1.1 mg/dL
Conversion of units cCrea (mol/L) = 88.40 cCrea (mg/dL)
T T
6-13
Input parameters
Definition Input parameters are the parameters keyed in by the operator on the Patient T
Identification screen or transferred from an interfaced database.

T
All input parameters are given in this section.
T
Definition Patient temperature
T
o
Unit P C; oF
P P P
o
Measuring range P C: 15.0-45.0
P
o
P F: 59-113
P
Conversion 9 o 5
T F = T C + 32 ; T C = (T oF 32)
5 9
T T T T
FO2(I)
Definition Fraction of oxygen in dry inspired air
B B
Unit %; fraction
Input range %: 0-100
fraction: 0.000-1.000
ctHb Is used in the ABL800/05 FLEX analyzers.

Definition Concentration of total hemoglobin in blood
Input range /Unit g/dL: 0.0-33.0
g/L: 0-330
mmol/L: 0.0-20.5
Conversion ctHb (g/dL) = 1.61140 ctHb (mmol/L);
T T
ctHb (g/L) = 16.1140 ctHb (mmol/L);

ctHb (mmol/L) = 0.62058 ctHb (g/dL) =
0.062058 ctHb (g/L)
RQ Definition Respiratory quotient, ratio between the CO2 B B
production and the O2 consumption B B
Input range 0.00-2.00
6-14
Input parameters, Continued T T
pO2(v ) B B
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)
T T T T
p(mmHg) = 7.500638 p(kPa)

T T
sO2(v ) B B
Definition Oxygen saturation of mixed venous blood
Input range/Unit %: 0.0-100.0
fraction: 0.000-1.000
QtB B Definition Cardiac output; volume of blood delivered from

the left ventricle into the aorta per unit of time
Also termed CO or C.O.
Input range/Unit 0.0-1000.0 L/min

VO2 B B
Definition Oxygen consumption; total amount of oxygen
utilized by the whole organism per unit of time
Input range/Unit mL/min: 0-xxxx
mmol/min: 0.0-xxx.x
Conversion (mmol/L)min = (mL/dLmin)/22.41
VCO
Definition Volume of carbon monoxide added to the patient
for measurement and calculation of V(B) [5]
Input range/Unit 0.0-1000.0 mL
6-15
Input parameters, Continued T T
p50(st) Can also be a derived parameter.

Definition Partial pressure (or tension) of oxygen at half
saturation (50 %) in blood at standard conditions:
temperature = 37 oC P P
pH = 7.40
pCO2 = 5.33 kPa
B B
FCOHb, FMetHb, FHbF set to 0

p50(st) may, however, vary due to variations in
T T
2,3-DPG concentration or to the presence of

abnormal hemoglobins.
Input range/Unit mmHg; torr: 0.01-100.00
kPa: 0.001-13.332
Conversion p(kPa) =0.133322 p(mmHg; torr)
T T T T
p(mmHg; torr) = 7.500638 p(kPa)

T T
FCOHb(1)
Definition The fraction of COHb measured before the CO-
injection
Input range/Unit %: 0.0-100.0
fraction: 0.000-1.000
FCOHb(2)
Definition The fraction of COHb measured after the CO-
injection
Input range/Unit %: 0.0 - 100.0
fraction: 0.000 - 1.000
6-16
Derived parameters
General In the Type column the following symbols are used:

T T
information
ms for measured parameters
dv for derived parameters
Acid-base
derived Symbol Definition Type Eq.
parameters pH(T) T T pH of blood at patient temperature. dv 1
T T
cH+(T) P P T T Concentration of hydrogen ions in blood at dv 2

T T
patient temperature.
pCO2(T) B B T T Partial pressure (or tension) of carbon dioxide at dv 3
T T
cHCO3(P) B PB P Concentration of hydrogen carbonate in plasma dv 4
T T
(also termed actual bicarbonate).

cBase(B)
T T Actual Base Excess, the concentration of titrable dv 5
T T
base when the blood is titrated with a strong base

or ABE
or acid to a plasma pH of 7.40, at pCO2 of B B
5.33 kPa (40 mmHg) and 37 oC, at the actual

P P
oxygen saturation [4,5].

Positive values (base excess) indicate a relative
deficit of non-carbonic acids; negative values
(base deficit) indicate a relative excess of non-
carbonic acids.
cBase(B,ox)
T T cBase(B) of fully oxygenated blood.
T T dv 6
T T
cBase(Ecf)
T T Standard Base Excess, an in vivo expression of dv 7
T T
base excess [5, 6]. It refers to a model of the

or SBE
extracellular fluid (one part of blood is diluted by
two parts of its own plasma) and is calculated
using a standard value for the hemoglobin
concentration of the total extracellular fluid.
cBase(Ecf,ox)
T T cBase(Ecf) of fully oxygenated blood.
T T dv 8
T T
cHCO3(P,st) B PB P Standard Bicarbonate, the concentration of dv 9

T T
hydrogen carbonate in the plasma from blood

which is equilibrated with a gas mixture with
pCO2 = 5.33 kPa (40 mmHg) and
B B
pO2 13.33 kPa (100 mmHg) at 37 oC [4,5].

B B P P
ctCO2(P)
T T B B Concentration of total carbon dioxide, (free CO2 B B dv 10
T T
+ bound CO2) in plasma. B B
6-17
Derived parameters, Continued T T
Acid-base
parameters ctCO2(B)
T T B B Concentration of total carbon dioxide in whole dv 11
T T
(continued)
T
blood (also termed CO2 content).
B B
Calculated based on the total CO2 concentrations

B B
in the two phases: plasma and erythrocyte fluid

[5].
pH(st) Standard pH (or eucapnic pH), defined as the pH dv 12
T T
of plasma of blood equilibrated to

pCO2 = 5.33 kPa (40 mmHg).
B B
By ensuring the normal value of pCO2, the B B
respiratory influence from pH is removed, and

pH(P,st) therefore reflects the metabolic status of
the blood plasma.
VCO2/V(dry
T T B B T T The volume fraction of carbon dioxide in dry air. dv 51
T T
air)
Oximetry
parameters FHHb Fraction of deoxyhemoglobin in total hemoglobin ms/dv 41
T T
in blood.
Deoxyhemoglobin is the part of total hemoglobin
which can bind oxygen forming oxyhemoglobin.
It is also termed reduced hemoglobin, RHb.
FO2Hb B B Fraction of oxyhemoglobin in total hemoglobin in ms/dv 40
T T
blood.
sO2 B B Oxygen saturation, the ratio between the ms/dv 39
T T
concentrations of oxyhemoglobin and the

hemoglobin minus the dyshemoglobins.
Hct Hematocrit, the ratio between the volume of dv 13
T T
erythrocytes and the volume of whole blood.
6-18
Oxygen derived
parameters Symbol Definition Type Eq.
pO2(T) B B T T Partial pressure (or tension) of oxygen at patient dv 14
T T
temperature.
pO2(A) B B Partial pressure (or tension) of oxygen in dv 15
T T
alveolar air.
pO2 (A,T) B B T T Partial pressure (or tension) of oxygen in dv 16
T T
alveolar air at patient temperature.

pO2(a)/ B B Oxygen tension ratio of arterial blood and the dv 17
T T
FO2(I)
T T B B fraction of oxygen in dry inspired air
pO2(a,T)/ B B T T Oxygen tension ratio of arterial blood at patient dv 18
T T
FO2(I)
T T B B temperature and the fraction of of oxygen in
dry inspired air
p 50
T T Partial pressure (or tension) of oxygen at half dv 19
T T
saturation (50 %) in blood.

High and low values indicate decreased and
increased affinity of oxygen to hemoglobin,
respectively.
p50(T)
T T T T Partial pressure (or tension) of oxygen at half dv 20
T T
saturation (50 %) in blood at patient

temperature.
p50(st)
T T Partial pressure (or tension) of oxygen at half dv/in 21
T T
saturation (50 %) in blood at standard

conditions: temperature = 37 oC P P
pH = 7.40
pCO2 = 5.33 kPa
B B
FCOHb, FMetHb, FHbF set to 0

p50(st) may however vary due to variations in
T T
2,3-DPG concentration or to the presence of

abnormal hemoglobins.
pO2(Aa)
T T B B
Difference in the partial pressure (or tension) of dv 22
T T
oxygen in alveolar air and arterial blood.

Indicates the efficacy of the oxygenation process
in the lungs.
pO2(Aa,T) Difference in the partial pressure (or tension) of
B B T T
dv 23
T T
oxygen in alveolar air and arterial blood at

6-19
Oxygen derived
(continued)
T
pO2(a/A) B B Ratio of the partial pressure (or tension) of dv 24
T T
oxygen in arterial blood and alveolar air.

Indicates the efficacy of the oxygenation process
in the lungs.
pO2(a/A,T) B B T T Ratio of the partial pressure (or tension) of dv 25
T T
oxygen in arterial blood and alveolar air at

pO2(x) or px Oxygen extraction tension of arterial blood.
B B T TB B dv 26
T T
Reflects the integrated effects of changes in the

arterial pO2(a), ctO2 and p50 on the ability of
B B B B T T
arterial blood to release O2 to the tissues [8]. B B
pO2(x,T) or B B T T Oxygen extraction tension of arterial blood at dv

px(T)
T TB B T T patient temperature.
ctO2(B) B B Total oxygen concentration of blood. dv 27
T T
Also termed O2 content.

B B
ctO2(av ) Oxygen concentration difference between dv 28

T T
arterial and mixed venous blood.

B B
BO2 B B Hemoglobin oxygen capacity; the maximum dv 29

T T
concentration of oxygen bound to hemoglobin in

blood saturated, so that all deoxyhemoglobin is
converted to oxyhemoglobin.
ctO2(x) B B Extractable oxygen concentration of arterial blood. dv 30
T T
Defined as the amount of O2 which can be B B
extracted per liter of arterial blood at an oxygen

tension of 5.0 kPa (38 mmHg), maintaining
constant pH and pCO2 [8]. B B
Oxygen delivery; the total amount of oxygen dv 31

DO2
T T
delivered to the whole organism per unit of time.

B B
Cardiac output; volume of blood delivered from dv/in 32

Qt
T T
the left ventricle into the aorta per unit of time.

B B
Also termed CO or C.O.

Oxygen consumption; total amount of oxygen dv/in 33
VO2
T T
utilized by the whole organism per unit of time.

B B
FO2(I)
T T B B Fraction of oxygen in dry inspired air. in
6-20
Oxygen derived
(continued)
T
FShunt
T T Relative physiological shunt or concentration- dv 34
T T
based shunt [5,8,9].

Calculated from the pulmonary shunt
equation:
&
Q 1
s
=
&
Qt ctO 2 (a v)
1+
ctO 2 (A ) ctO 2 (a)
if both arterial and mixed venous blood
samples are used.
May be estimated from one arterial sample
by assuming a constant difference in the
concentrations of total oxygen in arterial
and mixed venous blood:
ctO 2 (a v) = 2.3 mmol / L (5.1 mL / dL)
FShunt (T)
T T T T FShunt at patient temperature.
T T dv 35
T T
RI Respiratory Index; ratio between the oxygen dv 36

T T
tension difference of alveolar air and arterial

blood and the oxygen tension of arterial blood.
RI(T) T T Respiratory Index; ratio between the oxygen dv 37
T T
tension difference of alveolar air and arterial

blood and the oxygen tension of arterial blood at
VO2/V(dry
T T B B T T Volume fraction of oxygen in dry air. dv 52
T T
air)
Qx B B Cardiac oxygen compensation factor of arterial dv 38
T T
blood defined as the factor by which the cardiac

output should increase to allow release of 2.3
mmol/L (5.1 mL/dL) oxygen at a mixed venous
pO2 of 5.0 kPa (38 mmHg) [5,8].
B B
V(B)
T T Volume of blood, calculated when FCOHb and dv 42
T T
V(CO) values are keyed in [5].

GFR, if AA Glomerular filtration rate, if African American dv 53
T T
GFR, Glomerular filtration rate, if non African dv 54

T T
if non AA American
6-21
Units of derived parameters
Calculated Derived parameters are calculated or estimated on the basis of measured and
versus estimated keyed-in data. Calculations are made using equations programmed into the
parameters analyzer. The accuracy of the calculations depends on the input parameters keyed
into the analyzers computer.
If the calculation of a parameter requires input from the operator, but this input is
not forthcoming, the analyzer will use certain default values (refer to the section
Default Values in this chapter).
T T
Not all input parameters are stored as defaults. In these instances the dependent
derived parameter will not be reported if the relevant input parameter(s) is/are not T T
entered.
If the default values are used in the calculation of a parameter, then a parameter is
considered estimated ("e") rather than calculated ("c").
T T T T
Acid-base The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters measure ctBil and FHbF.
T T
Number of characters before "." is variable; number of decimals is constant.

Symbol Unit Num- ABL ABL 81x/ ABL825/82 Input Sample type
ber of 805 820 7/83x parameter
deci- FLEX FLEX FLEX
mals
pH(T) T T - .xxx c c c T
T T
+
cH (T)
T T P P T T nmol/L .x c c c T
T T
pCO2(T) B B T T mmHg; .x c c c T
T T
torr
kPa .xx
cHCO3(P) B PB P mmol/L .x c c c
cBase(B)
T T mmol/L Range c c c ctHb
30.0 e c c
cBase(B,ox)
T T mmol/L .x e c c ctHb
e c c
cBase(Ecf)
T T mmol/L Range c c c
30.0
cBase(Ecf,ox)
T T mmol/L .x e c c
cHCO3(P,st) B PB P mmol/L .x c c c ctHb
e c c
6-22
Units of derived parameters, Continued T T
Acid-base The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters measure ctBil and FHbF.
T T
(continued)
T
Symbol Unit Num- ABL ABL 81x/ ABL825/827/ Input Sample

ber of 805 820 83x parameter type
mals
Vol %, .x c c c
mL/dL,
ctCO2(P)
mmol/L
T T TB TB
ctCO2(B)
T T TB TB Vol %, .x c c c ctHb
mL/dL,
mmol/L
pH(st) - .xxx c c c
VCO2/V(dry
T T B B T T % .x c c c
air) fraction .xxx
Oximetry The ABL83X FLEX analyzer corresponds to ABL82X FLEX analyzer, but it can
parameters measure ctBil and FHbF).
T T

mals
Hct % ctHb
fraction .xxx c c c
sO2 B B % .x
fraction .xxx e
FO2Hb
T T B B % .x
fraction .xxx e e c
FHHb % .x
fraction .xxx e e c
6-23
Oxygen The ABL83X analyzer corresponds to ABL82X analyzer, but it can measure ctBil T T
parameters and FHbF). Number of characters before "." is variable; number of decimals is
constant.
mals
pO2(T) B B T T mmHg; .x e e c T
T T
torr
kPa .xx
pO2(A) B B mmHg; .x c c c FO2(I)+RQ
T T B B Arterial,
torr
kPa .xx e e e capillary
pO2(A,T)B B T T mmHg; .x c c c FO2(I)+RQ+T Arterial,
T T B B T T
torr capillary
kPa .xx e e e
p 50
T T mmHg; .xx e e e*
torr
kPa .xx
p50(T)
T T T T mmHg; .xx e e c* T
T T
torr
kPa .xx
p50(st)
T T mmHg; .xx e e c*
torr
kPa .xx
pO2(Aa)B B
mmHg; .x c c c FO2(I)+ RQ
T T B B Arterial,
torr
pO2(Aa,T)
B B T T
mmHg; .x e e c FO2(I)+RQ+T Arterial,
T T B B T T
torr
pO2(a/A)B B % .x c c c FO2(I)+RQ
T T B B Arterial,
fraction .xxx e e e capillary
pO2(a/A, T)
B B T T % .x c c c FO2(I)+RQ+T Arterial,
T T B B T T
fraction .xxx e e e capillary

pO2(a)/FO2(I)
B B T T B B mmHg; .x c c c FO2(I)
T T B B Arterial,
torr
kPa .xx capillary
6-24
Units of derived parameters, Continued T
Oxygen The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters T measure ctBil and FHbF.
T T
(continued)
T

mals
pO2(a,T)/ B B T T % .x c c c FO2(I)+T
T T B B T T
FO2(I)
T T B B fraction .xx
pO2(x) B B mmHg; torr .x e e* c* ctHb+p50(st) T T Arterial,
kPa .xx - e* c* capillary
pO2(x,T) B B T T mmHg; torr .x e e* c* ctHb+p50(st)+T T T T T Arterial,
kPa .xx - e* c* capillary
ctO2(B) B B Vol %, .x e e c ctHb
mL/dL,
mmol/L
ctO2(av ) Vol %, .x e e c ctHb Venous +

mL/dL,
B B
arterial
mmol/L
BO2 B B Vol %, .x e e c ctHb
mL/dL,
mmol/L
ctO2(x) B B Vol %, .x e e* c* ctHb +p50(st) P P T T P P Arterial,
mL/dL, capillary
mmol/L
mL/min e e c Arterial,
DO2 B B Qt B B
mmol/min .x capillary
L/min .x e e c Venous +
Qt V O2
arterial
B B
B B
mL/min e e c Venous +
V O2 B B
Qt B B
mmol/min .x arterial
FShunt
T T % .x e e c* ctHb Venous
fraction .xxx + arterial
FShunt(T)
T T T T % .x e e c* ctHb + T T T Venous +
fraction .xxx arterial
6-25
Oxygen The ABL83x FLEX analyzer corresponds to ABL82x FLEX analyzer, but it can
parameters T measure ctBil and FHbF.
T T
(continued)
T
Symbol Unit Num- ABL ABL ABL825/827 Input Sample

ber of 805 81x/ 820 /83x parameter type
mals
RI % c c c FO2(I)+RQ
T T B B Arterial,
fraction .xx e e e capillary
RI(T) T T % e e c FO2(I)+RQ+
T T B B T Arterial,
T T capillary
fraction .xx e e e T
T T
VO2/V (dry
T T B B T T % .x c c c
air) fraction .xxx
Qx B B - .x e e* c* ctHb1) P Arterial,
+p50(st) 1)
P T T P P capillary
e e* c*
V(B)
T T L .x c c c ctHb+VCO+ T T
FCOHb(1)+
FCOHb(2)
* If the sO2 value for establishing the ODC is greater than 0.97, the calculation of
B B
the parameter is not performed unless the p50(st) value is keyed in.
T T
1)
P If not measured, e.g. ctHb (or derived by analyzer, e.g. p50(st)).
P T T
Electrolyte Numerical format: number of characters before "." is variable; number of decimals
parameters is constant.
Symbol Unit Num- ABL8x5/8x7 Input Sample
ber of FLEX parameter type
deci-
mals
Anion Gap, K+ P P meq/L, mmol/L .x c2)P P
3)
Anion Gap meq/L, mmol/L .x c P P
cCa2+(7.4) P P meq/L, mg/dL, mmol/L .x c4)P P
mOsm
T T mmol/kg .x c5)P P
2) If the analyzer includes K, Na and Cl electrodes.

3) If the analyzer includes Na and Cl electrodes.
4) If the analyzer includes Ca electrode.
5) If the analyzer includes Na and Glucose electrodes.
6-26
Metabolite Numerical format: number of characters before "." is variable; number of decimals
parameters is constant.
Symbol Unit Num- ABL8x7 Input Sample
ber of FLEX parameter type
deci-
mals
GFR, if AA mol/L c6)
P P Crea, Sex, Arterial
Age
GFR, if non AA mol/L c6)
P P Crea, Sex, Arterial
Age
6) For patients >18 years [24].
6-27
List of equations
Units and All definitions and equations are based on SI units. If "T" for patient temperature is
symbols not stated, the calculation is based on a temperature of 37.0 C.
The following SI units are used:
concentration in mmol/L
temperature in C
pressure in kPa
fractions (not %)
The following symbols are used in the equations:

log(x) = log10(x) B B
ln(x) = loge(x) B B
If ctHb is not measured or keyed in, the default value will be used.
If sO2 is not measured, it will be calculated from equation 39.
B B
pH(T) T T Eq. 1
T [13]:
T T
pH(T ) = pH(37) 0.0146 + 0.0065 pH(37)- 7.40 [ ( )][T -37]

cH+(T)
T T P P T T Eq. 2:
T T
cH + (T )=10 (
9 pH ( T ) )
pCO2(T)
T T B B Eq. 3
T [4]:
T T
pCO 2 (T ) = pCO 2 (37) 10[ ]

0.021 ( T - 37 )
cHCO3(P)
T T B PB P Eq. 4
T [5]:
T T
cHCO -3 (P) = 0.23 pCO 2 10 ( )

pH - pK p
where
pK p =6.125log 1+10 (pH 8.7 ) [ ]
cHCO3(P) includes ions of hydrogen carbonate, carbonate and carbamate in the
B PB P
plasma.
6-28
List of equations, Continued T T
cBase(B)
T T Eq. 5
T [4,14]:
T
2
8a'-0.919 0.919 - 8a' 24.47 cHCO -3 (5.33)
cBase(B) = 0.5 + 0.5 4
a' a' a'
where
Eq. Description
5.1 a'= 4.04 10 -3 + 4.25 10 4 ctHb
5.2 ( pH(st) 6.161)

- 0.9524
cHCO 3 (5.33) = 0.23 5.33 10
5.3 5.33 pH(Hb) pH

pH(st) = pH + log
pCO 2 log pCO 2 ( Hb) log(7.5006 pCO 2 )
pH(Hb) = 4.06 10 2 ctHb +5.98- 1.92 10 (

5.4 0.16169 ctHb )
10 2 ctHb + 3.4046+ 2.12 10(

5.5 0.15158 ctHb )
log pCO 2 (Hb) = 17674
.
cBase(B,ox)
T T Eq. 6
T T [4]:
cBase(B,ox) = cBase(B) 0.3062 ctHb (1 sO 2 )
cBase(Ecf)
T T Eq. 7
T T [5]:
cBase(Ecf) = cBase(B) for ctHb = 3 mmol/L
cBase(Ecf,ox)
T T Eq. 8:
T T
cBase(Ecf,ox) = cBase(B,ox) for ctHb = 3 mmol/L
cHCO3(P,st)
T T B PB P Eq. 9
T [4,14]:
T
cHCO -3 ( P,st) = 24.47 + 0.919 Z + Z a'( Z -8)
where
Eq. Description
9.1 a'= 4.04 10 -3 + 4.25 10 4 ctHb
9.2 Z = cBase(B)- 0.3062 ctHb (1- sO 2 )
ctCO2(P)
T T B B Eq. 10 [4,5]:
T T
ctCO 2 ( P) = 0.23 pCO 2 + cHCO 3- ( P)

6-29
ctCO2(B)
T T B B Eq. 11 [5]:
T T
ctCO 2 (B)=9.286 10 3 pCO 2 ctHb 1 + 10 [ (pH Ery pK Ery )

]
ctHb
+ctCO 2 (P) 1
21.0
where
Eq. Description
11.1 pH Ery = 7.19 + 0.77 ( pH - 7.40) + 0.035 (1 sO 2 )
11.2 . log 1+10 (

pK Ery = 6125 [ pH Ery 7 .84 0.06 sO 2 )
]
pH(st) Eq. 12 [14]:
T T
pH(st): see equations 5.3-5.5.
Hct Eq. 13 [15]:

Hct = 0.0485ctHb + 8.310-3 T T P P
Hct cannot be calculated on the basis of a default ctHb value.
pO2(T)
T T B B T T Eq. 14 [16,17]:
T T
The standard Oxygen Dissociation Curve (ODC) is used (i.e. p50(st) = 3.578 kPa) at
actual values of pH, pCO2, FCOHb, FMetHb, FHbF (see equations 46-47 in the
B B
section Oxyhemoglobin Dissociation Curve further in this chapter).

T T
pO2(T) is calculated by a numerical method using:

B B T T
t i ( T ) = ctHb (1- FCOHb - FMetHb) sO 2,i (T ) + O 2 (T ) pO 2,i (T )
where
Eq. Description See

14.1 S = ODC(P,A,T) T T Eq. 47
14.2 S (1- FMetHb) FCOHb Eq. 46.12
sO 2,i ( T ) =
1- FCOHb - FMetHb
14.3 P Eq. 46.10
pO 2 ,i (T ) =
FCOHb
1+
sO 2,i (T ) (1 FCOHb FMetHb)
6-30
TpO2(T) T B B T T
Eq. Description See

(continued)
O 2 =9.8310 3 e [1.1510 (T -37.0 )+ 2.110 4 ( T -37.0 )2 ]
T T
2
14.4
14.5 P is the variable during iteration.

14.6 pH
A=ac-1.04 (T -37.0)
T
14.7 T= patient temperature in oC (keyed-in).
T T P P
pH
. 10 2 6.5 10 3 ( pH (37) 7.40)
14.8
= 146
(T )
When t i ( T ) = t i (37.0), then pO 2,i ( T ) = pO 2 ( T )
pO2(A)
T T B B Eq. 15 [5]: T T
pO 2 (A) = FO 2 (I) ( p(amb) - 6.275)
[
pCO 2 RQ 1 FO 2 (I) RQ 1 1 ( )]
If FO2(I) and RQ are not keyed in, they are set to the default values.
B B
The calculation requires entering the sample type as Arterial or Capillary.
pO2(A,T)
T T B B T T Eq. 16 [4,5,18]:
T T
pO 2 (A, T )= FO 2 (I) [ p (amb)- pH 2 O(T )]

[
pCO 2 (T ) RQ 1 FO 2 (I) RQ -1 1 ( )]
pH 2 O(T ) = 6.275 10
[ 2.3610 2
( T 37 .0 ) 9 .6 10 5 ( T 37 .0 )
2
]
If FO2(I) and RQ are not keyed in, they are set to the default values.
B B
6-31
pO2(a)/FO2(I)
B B T T B B Eq. 17:
T T
pO 2 (a)
pO 2 (a) / FO 2 (I) =
FO 2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and
T T B B
the calculation requires entering the sample as Arterial or Capillary.
pO2(a,T)/FO2(I)
B B T T T T B B Eq. 18:
T T
pO 2 (a , T )
pO 2 (a, T ) / FO 2 (I) =
FO 2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and
T T B B
the calculation requires entering the sample as Arterial or Capillary.
p50
T T Eq. 19 Refer to Eq. 46.10:
T T
The ODC is determined as described in equations 46-47 in the section

Oxyhemoglobin Dissociation Curve further in this chapter.
T T
P
p50 =
FCOHb
1+
0.5 (1- FCOHb - FMetHb )
where
Description See...
P = ODC(S,A,T) T T Eq. 47
0.5 (1 FCOHb - FMetHb) + FCOHb Eq. 46.11
S=
1- FMetHb
A=a
T = 37.0 oC
T T P P Eq. 46.13
p50(T)
T T T T Eq. 20:
T T
P
p50(T )=
FCOHb
1+
0.5 (1- FCOHb - FMetHb )
where
6-32
p50(T)
T T T T T
Description See
(continued) T
P = ODC(S,A,T) T T Eq. 47
0.5 (1 FCOHb - FMetHb) + FCOHb Eq. 46.11
S=
1- FMetHb
pH
A=a 1.04 (T 37.0)
(T )
pH
. 10 2 6.5 10 3 ( pH (37) 7.40)
= 146
(T )
T = patient temperature in oC (keyed-in)
T T P P
p50(st)
T T Eq. 21:
T T
p50 is calculated for pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF
B B
= 0.
Oxyhemoglobin Dissociation Curve, see equation 47 further in this chapter.
T T
p50(st) = ODC(S,A,T) T T
where
Description See
S = 0.5 Eq. 46.11
A = a6 corresponds to pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, B B Eq. 46.13
FMetHb = 0, FHbF = 0
T = 37.0 oC
T T P P
pO2(A-a)
T T B B Eq. 22:
T T T
pO 2 (A a) = pO 2 (A) - pO 2 (a)
pO2(A-a,T)
T T B B T T Eq. 23:
T T T
pO 2 (A a, T ) = pO 2 (A, T ) pO 2 (a, T )
6-33
pO2(a/A)
T T B B Eq. 24:
T T T
pO 2 (a)
pO 2 (a/A) =
pO 2 ( A )
pO2(a/A,T)
T T B B T T Eq. 25:
T T T
pO 2 (a, T )
pO 2 (a/A, T ) =
pO 2 (A, T )
pO2(x)
B B Eq. 26 [8]:
T T T
(or px) T TB B The ODC is determined as described in equations 46-47 in the section
T T
pO2(x) is calculated by a numerical method, using:

B B
Eq. Description See

26.1 S = ODC(P,A,T) T T Eq. 47
26.2 S (1 FMetHb) FCOHb Eq. 46.12
sO 2,i =
1 FCOHb FMetHb
26.3 P Eq. 46.10
pO 2,i =
FCOHb
1+
sO 2,i (1 FCOHb FMetHb)
26.4 t i = ctHb (1 FCOHb FMetHb) sO 2,i +

+ 9.83 10 3 pO 2,i
26.5 A=a
26.6 T = 37 oC
T T P P
When ti = ctO2 2.3 mmol/L, then pO2,i = pO2(x), where ctO2 is determined as
B B B B B B B B B B
described in equation 27.

pO2(x) cannot be calculated on the basis of a default ctHb value.
B B
pO2(x) can only be calculated if the measured sO2(a) 0.97 (or p50(st) keyed in).
B B B B
The calculation requires entering the sample type as "Arterial" or "Capillary".
6-34
ctO2
T T B B Eq. 27 [5]:
T T
ctO 2 = O 2 pO 2 + sO 2 (1 FCOHb FMetHb) ctHb

O2 is the concentrational solubility coefficient for O2 in blood (here set to
B B B B
9.83 x 103 mmolL1kPa1 at 37 oC [5,19]. P P P P P P P P
ctO2 cannot be calculated on the basis of a default ctHb value.

T T B B T T
ctO2(av )
T T B B
Eq. 28:
ctO2(a v ) = ctO2(a) ctO2(v )
B B B B B B
where ctO (a) and ctO (v ) are calculated from equation 27 for arterial and mixed
2
B B
2
B B
venous blood, respectively. The calculation requires two measurements.
BO2
T T B B Eq. 29 [7]:
T T T
BO2 = ctHb (1 FCOHb FMetHb)

BO2 cannot be calculated on the basis of a default ctHb value.
B B
ctO2(x)
T T B B Eq. 30 [8]:
T T
(or cx)
The ODC is determined, as described in equations 46-47 in the section
T TB B

T T
ctO 2 ( x) = ctO 2 ( a) t i
where
Eq. Description See

30.1 t i = ctHb (1 FCOHb - FMetHb) sO 2,i +
+ 9.83 10 3 pO 2 (5)
30.2 pO2(5) = 5.00 kPa
B B
30.3 S = ODC(P,A,T) T T Eq. 47

30.4 FCOHb Eq. 46.9
P = pO 2 (5) 1 +
sO 2,i (1 FCOHb FMetHb)
sO 2,i =
(1 FCOHb FMetHb)
30.6 A=a
30.7 T = 37.0 oC
T T P P
6-35
ctO2(x)
T T B B ctO2(a) is determined as described in equation 27.
B B
(or cx)
ctO2(x) cannot be calculated on the basis of a default ctHb value.
B B T
(continued)
B B
ctO2(x) can only be calculated if the measured sO2(a) 0.97 (or if p50(st) is keyed
B B B B
in).
Eq. 31:
D O2
. .
B B
D O 2 = ctO 2 Q t

Q t is the cardiac output and is an input parameter for calculation of DO2.
B B B B

If Q t is not keyed in, DO2 will not be calculated.
B B B B
Eq. 32:
Qt
.
B B
. V O2
Qt =
ctO 2 ( a v)

If V O2 is not keyed in, Q t will not be calculated.
B B B B
Eq. 33:
VO2
. .
B B
V O 2 = Q t ctO 2 (a v)

If Q t is not keyed in, VO2 will not be calculated.
B B B B
T FShunt T Eq. 34 [5]: T T
ctO 2 ( c) ctO 2 (a )
FShunt =
ctO 2 (c) ctO 2 ( v)
and
Eq. Description
34.1 ctO 2 (A ) ctO 2 ( a )
FShunt
ctO 2 ( A ) ctO 2 ( v)
6-36
List of equations, Continued

T T
FShunt
T T
Eq. Description
(continued)
T T
1
34.2 ctO 2 (a ) ctO 2 ( v )
FShunt = 1 +
ctO 2 (A ) ctO 2 (a )
where
ctO2(c): total oxygen in pulmonary capillary blood
B B
ctO2(a): total oxygen in arterial blood

B B
ctO2(A): total oxygen in alveolar air. Oxygen tension = pO2(A).

B B B B
ctO2(v ): total oxygen in mixed venous blood

B B
34.3 ctO 2 (a ) = 9.83 10 3 pO 2 (a) + ctHb (1 FCOHb FMetHb ) sO 2 (a)

34.4 ctO 2 (A) = 9.83 10 3 pO 2 (A) + ctHb
(1 FCOHb FMetHb ) sO 2 (A)
34.5 ctO 2 ( v) = 9.83 10 3 pO 2 ( v) + ctHb
(1 FCOHb FMetHb ) sO 2 ( v)
where:
pO2(a): oxygen tension in arterial blood; measured
B B
pO2(A): oxygen tension in alveolar blood. See equation 15.

B B
pO (v ): oxygen tension in mixed venous blood; measured and then

2
B B
entered
sO2(a): oxygen saturation in arterial blood; can be measured
B B
sO2(A): oxygen saturation in (alveolar) blood calculated from equation 39

B B
where P = pO2(A). If sO2(a) > 0.97, a keyed-in p50(st) will be used to

B B B B
determine the ODC. If sO2(a) > 0.97 and no p50(st) has been keyed in, the
B B
default value (3.578 kPa) will be used to determine the ODC.

sO (v ): oxygen saturation in mixed venous blood
2
B B
If not keyed in, it will be calculated from equation 39 where P = pO2(v ). B B
If sO2(a) > 0.97, a keyed-in p50(st) will be used to determine the ODC.
B B
The calculation requires entering the sample type as Arterial or

Capillary.
If sO2(a) > 0.97 and no p50(st) has been keyed in, the default value (3.578
B B
kPa) will be used to estimate the ODC.

If no venous sample is measured, FShunt is estimated assuming:
ctO2(a) ctO2(v ) = 2.3 mmol/L in equation 34.2

B B B B
6-37
FShunt(T)
T T T T Eq. 35 [5,16]:
T T
1
ctO 2 (a, T ) - ctO 2 (v, T )
FShunt(T ) = 1 +
ctO 2 (A, T ) - ctO 2 (a, T )
where
ctO2(a,T): total oxygen in arterial blood at patient temperature
B B T T
ctO2(A,T): total oxygen in alveolar blood at patient temperature ctO2(v ,T): total
B B T T B B T T
oxygen in mixed venous blood at patient temperature
Eq. Description See

35.1 ctO2(a,T) = ctO2 calculated from equation 25 for arterial pO2
B B T T B B B B
and sO2 values at 37 oC B B P P
35.2 ctO 2 (A , T ) = O 2 (T ) pO2 (A , T )

+ ctHb (1 - FCOHb - FMetHb) sO 2 (A, T )
O2 (T ) = 9.83 10 3 e [ ]
35.3 -1.1510 -2 ( T -37.0 ) + 2 .110 4 (T 37 .0 )
2
35.4 pO2(A,T) is calculated from equation 15

B B T T
35.5 sO2(A,T) = SB B T T
35.6 S = ODC(P,A,T) T T Eq. 47

35.7 P = pO2(A,T) B B T T
35.8 pH
A = a 104
. (T 37.0)
(T )
35.9 T = patient temperature (keyed-in)
T T
35.10 pH
. 10 2 6.5 10 3 ( pH (37) 7.40)
= 146
(T )
If sO2(a) > 0.97, a keyed-in p50(st) will be used to determine the
B B
ODC. If sO2(a) > 0.97 and no p50(st) has been keyed in, the B B
default value (3.578 kPa) will be used to determine the ODC.

35.11 ctO2(v ,T) = ctO2(v ) at 37 oC is calculated from equation 27 for
B B T T B B P P
mixed venous blood values of pO2 and sO2. If sO2(v ) > 0.97, a B B B B B B
keyed-in p50(st) will be used to determine the ODC.
If sO2(v )>0.97 and no p50(st) has been keyed in, the default
B B
value (3.578 kPa) will be used to estimate the ODC. If no mixed

venous sample is measured, the FShunt(T) is estimated T T
assuming ctO (a,T) ctO (v ,T) = 2.3 mmol/L in equation 35. B

2 B T T
2
B B T T
6-38
RI Eq. 36:
T T T
pO 2 (A ) pO 2 ( a)
RI =
pO 2 (a )
RI(T) T T Eq. 37:

T T T
pO 2 (A , T ) pO 2 (a, T )
RI(T ) =
pO 2 (a , T )
Qx
B B Eq. 38 [8]:
T T

T T
2.3
Qx =
ctO 2 (a ) t i
Eq. Description See

38.1 t i = ctHb (1 - FCOHb - FMetHb) sO 2, i + 9.83 10 3 pO 2 (5)
38.2 pO2(5) = 5.00 kPa

B B
38.3 S = ODC(P,A,T) T T
38.4 FCOHb Eq. 46.9

P = pO 2 (5) 1 +
sO 2,i (1 FCOHb FMetHb )
sO 2,i =
1 - FCOHb - FMetHb
38.6 A=a
38.7 T = 37.0 oC
T T P P
ctO2(a) is determined as described in equation 27.

B B
Qx cannot be calculated on the basis of a default ctHb value.

Qx can only be calculated if the measured sO2(a) 0.97 (or if p50(st) is keyed in).
B B B B
6-39
sO2
T T B B Eq. 39:
T T T
The ODC is determined as described in equation 46 (points I and III). See the section
T T
S (1 FMetHb) FCOHb
sO 2 =
1 - FCOHb - FMetHb
where
Description See
S = ODC(P,A,T) T T
pO 2 FCOHb Eq. 46.9

P = pO 2 +
sO 2 (1 FCOHb FMetHb)
A=a
T = 37.0 oC
T T P P
FO2Hb
T T B B Eq. 40:
FO 2 Hb = sO 2 (1 FCOHb FMetHb)
T T B B
If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default
values.
FHHb
T T Eq. 41:
FHHb = 1 sO 2 (1 FCOHb FMetHb) FCOHb FMetHb
T T B B
If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default
values.
V(B)
T T Eq. 42 [5]: T T
1 10 3 V (CO)
V ( B) =
24 ( FCOHb(2) FCOHb(1) ) 0.91 ctHb
6-40
V(B)
T T Eq. Description
(continued)
42.1 V (CO)
T T
V ( B) =
2.184 10 ( FCOHb(2) FCOHb(1) ) ctHb
-2
42.2 V(CO) = volume (in mL) of carbon monoxide injected according to the
procedure and the value keyed in
42.3 FCOHb(1) = fraction of COHb measured before the CO injection
42.4 FCOHb(2) = fraction of COHb measured after the CO injection
Anion Gap,K+ P P Eq. 43:

Anion Gap, K + = cNa + + cK + cCl cHCO 3 (P)
Anion Gap Eq. 44:

T T
AnionGap = cNa + cCl cHCO 3 (P)
cCa2+(7.4)
T T P P Eq. 45 Ref. [12]:
[
cCa 2 + (7.4) = cCa 2 + 1 0.53 (7.40 pH ) ]
Due to biological variations this equation can only be used for a pH value in the
range 7.2-7.6.
Eq. 46-47 See Oxyhemoglobin dissociation curve (ODC), page 6-44 in this chapter.
T T T T
mOsm
T T Eq. 48:
T
mOsm = 2cNa + + cGlu
FHbF Eq. 49:

T T
An iterative method is used to calculate FHbF. The input parameters are sO2, ceHb B B T T
(effective hemoglobin concentration) and cO2HbF (concentration of fetal oxyhe-

T T B B
moglobin).
In the calculations the following are assumed: pH = 7.4, pCO2 = 5.33 kPa, FCOHb B B
= 0, FMetHb = 0, cDPG = 5 mmol/L, and temp = 37 C.

T T
Step Description See

1. An estimate of FHbF is made: FHbFest = 0.8 B B
2. pO2,est = ODC (sO2,A,T);

B B B B B B T T Eq. 47
where the constant A depends on FHbF = FHbFest B B
6-41
FHbF
T T T
Step Description See

(continued) T
3. sO2 (for fetal blood) = ODC (pO2,est, A,T);

B B B B B B T T Eq.47
where FHbF = 1
4. cO2HbFest = sO2 (fetal blood) ceHb FHbFest
T T B B B B B B T T B B
5. cO 2 HbFmeas. cO 2 HbFest
FHbFest =
ceHb
6. If |FHbFest| 0.001, proceed to step 7.
T T B B T T
If |FHbFest| < 0.001, proceed to step 9.

T T B B T T
7. FHbFest, new = FHbFest, old + FHbFest B B B B T T B B
8. Return to step 2. T T
9. End of iteration. The value for FHbF has converged.
pO2(x,T)B B T T Eq. 50 [8]:

T T T
The ODC is determined as described in equations 46-47 in Oxyhemoglobin T
Dissociation Curve further in this chapter. T
pO2(x) is calculated by a numerical method, using:

B B
Eq. Description See

50.1 S = ODC(P,A,T) T T Eq. 47
50.2 S (1 FMetHb ) FCOHb Eq. 46.12

sO 2,i (T ) =
1 FCOHb FMetHb
50.3 P Eq. 46.10
pO 2,i (T ) =
FCOHb
1+
sO 2,i (T ) (1 FCOHb FMetHb )
50.4 t i (T ) = ctHb (1 FCOHb FMetHb ) sO 2,i (T ) +

+ O 2 (T ) pO 2,i (T )
50.5 A=a
50.6 T = patient temperature
T T
O 2 (T ) = 0.00983 e [0.115(T 37 )+ 2110 ]

5
50.7 (T 37 ) 2
6-42
pO2(x,T)
T T B B T T
Eq. Description
(continued)
T
50.8 pO 2,i = pO 2 (x, T )
when ti(T) = ctO2(37 C) 2.3 mmol/L

B B T T B B
pO2(x,T) is calculated in accordance with OSA V3.0.

B B T T
pO2(x,T) can only be calculated if the measured sO2(a) 0.97 (or p50(st) keyed in).
B B T T B B
pO2(x,T) is tagged with "?" if any of the following parameters: sO2, FMetHb,
B B T T B B
FCOHb, pO2, pCO2, pH or ctHb is tagged with "?". B B B B
VCO2/V(dry air) Eq. 51:

T T B B T T T T T
pCO 2
VCO 2 / V (dry air) =
p(amb) 6.275
VO2/V(dry air)
T T B B T T Eq. 52:
T T T
pO 2
VO 2 / V (dry air) =
p(amb) 6.275
GFR, if AA Eq. 53 [24, 25]:

T T T
GFR (mL/min/1.73 m 2 ) = 186 (S cr /88.4 ) (Age ) (0.742 if female)

1.154 -0.203
1.210
T
GFR, if non AA Eq. 54 [24, 25]: T T T
GFR (mL/min/1.73 m 2 ) = 186 (S cr /88.4 ) (Age) (0.742 if female)

1.154 -0.203
6-43
Oxyhemoglobin dissociation curve (ODC)
ODC equations These equations account for the effect of FCOHb on the shape of the
Oxyhemoglobin Dissociation Curve (ODC) in accordance with the Haldane
equation.
Eq. 46 [16,18]:
T T T
[ (
y y o = ( x x o ) + h tanh k o x x o )]
where ko = 0.5343
P P
Eq. Description
46.1 x = ln p
46.2 s
y = ln
1- s
46.3 so
y o = ln where so = 0.867
1 - so
T TP P
46.4 x o = x oo + a + b = ln( p oo ) + a + b where poo = 7 kPa

T TP P
The actual position of the ODC in the coordinate system (ln(s/(1s)) vs ln(p)) used in
the mathematical model, is expressed by equations 46.3 and 46.4.
The symbols "a" and "b" reflect the ODC displacement from the reference position
to its actual position in this coordinate system:
"a" describes the displacement at 37 C.
"b" the additional displacement due to the patient temperature difference from 37 C.
The ODC The reference position of the ODC was chosen to be the one that corresponds to the
reference default value for p50(st) = 3.578 kPa, which is traditionally considered the most
position likely value of p50 for adult humans under standard conditions, namely:
pH = 7.40
pCO2 = 5.33 kPa
B B
FCOHb, FMetHb, FHbF = 0

cDPG = 5 mmol/L
6-44
Oxyhemoglobin dissociation curve (ODC), Continued T T
The ODC The ODC displacement which is described by "a" and "b" in the coordinate system
displacement (ln(s/(1s))vsln(p)), is given by the change in p50 from the default to its actual value
in a more common coordinate system (sO2, pO2). B B B B
Eq. Description
46.5 p
x x o = ln ab
7
46.6 h = ho + a where ho = 3.5P P
46.7 b = 0.055 (T T o ) To = 37 oC
T TP P P P
46.8 p = pO 2 + M pCO
where M pCO is taken from the Haldane equation [20]:
pO 2 pCO
=M , to give eq. 46.9
cO 2 Hb cCOHb
46.9 pO 2 FCOHb
p = pO 2 + or equation 46.10
sO 2 1 - FCOHb - FMetHb
46.10
pO 2 =
[
p sO 2 (1 FCOHb FMetHb) ]
1 + FCOHb
The ordinate, s, may loosely be termed the combined

T T
oxygen/carbon monoxide saturation of hemoglobin and is

described by equation 46.11 below:
Eq. Description
46.11 cO 2 Hb + cCOHb
s=
cO 2 Hb + cCOHb + cHHb
or
sO 2 (1 - FCOHb - FMetHb) + FCOHb
=
1 FMetHb
46.12 s (1 - FMetHb) FCOHb
sO 2 =
1 FCOHb FMetHb
6-45
The actual ODC The actual position of the ODC at 37 C for a given sample is, in principle,
position determined in two steps:
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
position.
2. The computation by a numerical method of the actual position of the ODC curve
by shifting it to pass through the known set of coordinates (P0, S0). B B B B
Eq. Description
46.13 a = ac + a6
46.14 ac = a1 + a2 + a3 + a4 + a5
46.15 a1 = 0.88 (pH 7.40)
46.16 pCO 2
a2 = 0.048 ln
5.33
46.17 a3 = 0.7 FMetHb
46.18 a4 = (0.06 0.02 FHbF) (cDPG 5)
46.19 a5 = 0.25 FHbF
Determining the
actual Step Description
displacement I: pO2, sO2 can be used.
B B B B
If sO2 > 0.97, the calculation is based on II or III see

T T B B T
below. T
Coordinates (P0, S0) are calculated from equations (46.9)

B B B B
and (46.11).
If FCOHb and FMetHb are not known, the default values
are used.
The ODC is shifted from the reference position to a
position that corresponds to the effect of all measured
parameters according to step I.
The magnitude of the shift is ac.
The ODC is then further shifted to pass through the point
(P0, S0).
B B B B
The magnitude of the shift is "a6".
6-46
Determining the
actual Step Description
displacement T
II: sO2 > 0.97 (or erroneous) and p50(st) is keyed in.
B B
(continued)
Coordinates (P0, S0) are calculated from (p50(st), 0.5) using
T
B B B B
equations 46.9 and 46.11.

Reference position of the ODC.
The ODC is shifted from the reference position to pass

through the point (P0, S0). In this position, the ODC reflects
B B B B
the p50(st) of the patient, i.e., the particular patient but at

standard conditions.
The ODC is further shifted, as determined by the effect of

the measured parameters (ac), to its actual position. This
position reflects the p50(act) of the patient.
(III): sO2 > 0.97 (or erroneous) and no p50(st) has been keyed in.
B B
Reference position of the ODC.
The position of the actual ODC can now be approximated

from the reference position, using the actual values of pH,
pCO2, FCOHb, FMetHb and FHbF to determine the shift
B B
"ac".
NOTE:
T T The curves are used only to illustrate the principles of the ODC determination
6-47
Coordinates on Calculation of a set of coordinates on the ODC is symbolized by:

the ODC
Eq. 47:
T
S = ODC(P, A, T) or T T P = ODC(S, A, T)
T T
These equations are symbolic representations of the relationship between saturation

(S), tension (P), displacement (A) and temperature (T). T T
To calculate S or P and to further calculate sO2 and pO2, the other variables should
B B B B
be specified. S and P are calculated using numerical methods.

P is input to equation 46.1.
S is input to equation 46.2.
A is input to equation 46.5.
T is input to equation 46.7.
T T
6-48
Conversion of units
SI units The equations stated above are based on the SI-unit system. If parameters are known
in other units, they must be converted into a SI unit before entering the equations.
The result will be in an SI unit.
After the calculation the result may be converted to the desired unit. Conversion of
units may be performed, using the equations stated below:
Temperature 9
T F = (T o C ) + 32
5
T T
5
T C = (T oF 32)
9
T T
cK+, cNa+, cCl

P P P P P P cX (meq/L)
T T = cX (mmol/L)
T T where X is K+, Na+ or Cl.
P P P P P P
cCa2+ P P
cCa2+ (meq/L)
T T P P
2+
= 2 cCa (mmol/L) or
T T P P
2+
cCa2+ (mg/dL)
T T P P = 4.008 cCa (mmol/L) T T P P
2+
cCa2+ (mmol/L)
T T P P = 0.5 cCa (meq/L)or
T T P P
2+
cCa2+ (mmol/L)
T T P P = 0.2495 cCa (mg/dL) T T P P
Pressure p (mmHg) = p (torr) = 7.500638 p (kPa)
p (kPa) = 0.133322 p(mmHg) = 0133322

. p (torr)
ctHb [4]
ctHb (g/dL)
T T = 1.61140 ctHb (mmol/L)
ctHb (g/L) = 16.1140 ctHb (mmol/L) or
ctHb (mmol/L) = 0.62058 ctHb (g/dL)
ctHb (mmol/L) = 0.062058 ctHb (g/L)
ctCO2, ctO2,
T T B B B B
Vol % = 2.241 (mmol/L)

ctO (av ), BO
2 2
= mL/dL
T T B B T T B B
Vol %
mmol/L = 0.4462 (mL/dL)
6-49
Conversion of units, Continued T T

VO2 B B VO2 (mmol/L)/min = VO2/22.41 (mL/dL)/min
B B B B
T cGlucose
T
[22]
cGlucose (mg/dL) = 18.016 cGlucose (mmol/L) or

T T
cGlucose (mmol/L) = 0.055506 cGlucose (mg/dL) T T
cLactate
T T
[22]
cLactate (mg/dL) = 9.008 cLactate (mmol/L) or

T T
cLactate (mmol/L) = 0.11101 cLactate (mg/dL) T T
cLactate (meq/L) = cLactate (mmol/L)

(conversion based on the molecular weight of lactic acid)
ctBil
T T
ctBil (mol/L)
T T
= 17.1 ctBil (mg/dL)
ctBil (mol/L) = 1.71 ctBil (mg/L) or
ctBil (mg/dL) = 0.0585 ctBil (mol/L)
ctBil (mg/L) = 0.585 ctBil (mol/L)
cCrea
T T
cCrea (mol/L) = 88.40 cCrea (mg/dL)
T T
NOTE:
T T All conversions of units are made by the analyzer.
6-50
Default values
Values The following default values are used in the ABL800 FLEX analyzers, if other
values are not keyed in.
T
T T = 37.0 C (99 F)
FO2(I)
B B = 0.21 (21.0 %)
RQ = 0.86
ctHb = 9.3087 mmol/L, (15.00 g/dL or 150 g/L)
FCOHb = 0.004 (0.4 %)
FMetHb = 0.004 (0.4 %)
p50(st) = 3.578 kPa (26.84 mmHg)
In addition to the above default values, the ABL8x7 FLEX analyzers use the
following default:
Ambient temperature = 25.0 C (77 F).
6-51
Altitude correction
Equation for The barometric pressure is measured by the analyzer's built-in barometer, and the
altitude effect of barometric pressure on blood samples is compensated by the analyzers
correction software.
Quality control result for pO2 obtained on aqueous quality control solutions at low
B B
barometric pressure (at high altitudes) is affected as the properties of aqueous

solutions differ from those of blood. The deviation from the pO2 value obtained at
B B
sea level can be expressed by an altitude correction that can be added to the control
ranges.
The relationship between the altitude and barometric pressure can be expressed by
the following equation:
Bref Bact
A = 16000 (1 + 0.004T )
Bref + Bact
where:
A
T T = altitude in m
T
T T
= temperature in C
Bref
T B TB = standard barometric pressure at sea level = 760 mmHg
Bact
T B TB = actual barometric pressure in mmHg.
Reference [23].
6-52
References
List of 1. The Deep PictureTM, critical information from blood gas analysis. Copenhagen:
P P
references Radiometer Medical A/S, 1993: 1-14.

2. Wandrup JH. Physicochemical logic and simple symbol terminology of oxygen
status. Blood Gas News 1993; 2,1: 9-11.
3. Siggaard-Andersen O, Durst RA, Maas AHJ. Approved recommendation (1984)
on physicochemical quantities and units in clinical chemistry. J Clin Chem Clin
Biochem 1987; 25: 369-91.
4. Siggaard-Andersen O. The acid-base status of the blood. 4th revised ed.
Copenhagen: Munksgaard, 1976.
5. Siggaard-Andersen O, Wimberley PD, Fogh-Andersen N, Gthgen IH. Measured
and derived quantities with modern pH and blood gas equipment: calculation
algorithms with 54 equations. Scand J Clin Lab Invest 1988; 48, Suppl 189: 7-15.
6. Burnett RW, Noonan DC. Calculations and correction factors used in
determination of blood pH and blood gases. Clin Chem 1974; 20,12: 1499-1506.
7. Wimberley PD, Siggaard-Andersen O, Fogh-Andersen N, Zijlstra WG,
Severinghaus JW. Hemoglobin oxygen saturation and related quantities:
definitions, symbols and clinical use. Scand J Clin Lab Invest 1990; 50: 455-59.
Available as AS104.
8. Siggaard-Andersen O, Gthgen IH, Wimberley PD, Fogh-Andersen N. The
oxygen status of the arterial blood revised: relevant oxygen parameters for
monitoring the arterial oxygen availability. Scand J Clin Lab Invest 1990; 50,
Suppl 203: 17-28. Available as AS108.
9. Wandrup JH. Oxygen uptake in the lungs. Blood Gas News 1992; 1,1: 3-5.
10. Tietz NW, Logan NM. Reference ranges. In: Tietz NW, ed. Fundamentals of
clinical chemistry. 3rd ed. Philadelphia: WB Saunders Company, 1987: 944-75.
11. Siggaard-Andersen O, Wimberley PD, Fogh-Andersen N, Gthgen 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. Available as AS106.
12. Siggaard-Andersen O, Thode J, Wandrup JH. The concentration of free calcium
ions in the blood plasma ionized calcium. 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.
Available as ST36.
14. Christiansen TF. An algorithm for calculating the concentration of the base
excess of blood. 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: 77-81.
6-53
References, Continued
T T
List of 15. Kokholm G. Simultaneous measurements of blood pH, pCO2, pO2 and
B B B B
references concentrations of hemoglobin and its derivatives a multicenter study. Scand J

(continued)
T T Clin Lab Invest 1990; 50, Suppl 203: 75-86. Available as AS107.
16. Siggaard-Andersen O, Wimberley PD, Gthgen IH, Siggaard-Andersen M. A
mathematical model of the hemoglobin-oxygen dissociation curve of human
blood and of the oxygen partial pressure as a function of temperature. Clin Chem
1984; 30: 1646-51.
17. Siggaard-Andersen O, Wimberley PD, Gthgen IH, Fogh-Andersen N,
Rasmussen JP. Variability of the temperature coefficients for pH, pCO2 and pO2
B B B B
in blood. Scand J Clin Lab Invest 1988; 48, Suppl 189: 85-88.
18. Siggaard-Andersen O, Siggaard-Andersen M. The oxygen status algorithm: a
computer program for calculating and displaying pH and blood gas data. Scand J
Clin Lab Invest 1990; 50, Suppl 203: 29-45.
19. Bartels H, Christoforides C, Hedley-Whyte J, Laasberg L. Solubility coefficients
of gases. In: Altman PL, Dittmer DS, eds. Respiration and circulation. Bethesda,
Maryland: Fed Amer Soc Exper Biol, 1971: 16-18.
20. Roughton FJW, Darling RC. The effect of carbon monoxide on the
oxyhemoglobin dissociation curve. Am J Physiol 1944; 141: 17-31.
21. Engquist A.. Fluids electrolytes nutrition. Copenhagen: Munksgaard, 1985: 56-
68 and 118.
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. 3rd ed. Blood gas
measurements at high altitudes. Copenhagen: Radiometer Medical A/S, 1991.
Available as AS109.
24. U.S Department of Health and Human Services, National Institutes of Health,
National Institute of Diabetes and Digestive and Kidney Diseases: NKDEP
National Kidney Disease Education Program. Rationale for Use and Reporting of
Estimated GFR. NIH Publication No. 04-5509. Revised November 2005.
25. Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, Hostetter
T, Levey AS, Panteghini M, Welch M, and Eckfeldt JH for the National Kidney
Disease Education Program Laboratory Working Group. Clin Chem, 52:5-18,
2006; First published December 6, 2005, 10.1373/clinchem.2005.0525144.
6-54
7. Solutions and gas mixtures
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.

X X
Calibration solutions ........................................................................................ 7-3

X X
Rinse and Cleaning solutions ........................................................................... 7-6

X X
Electrolyte solutions......................................................................................... 7-8

X X
S5362 Hypochlorite Solution........................................................................... 7-10 X X
Gas mixtures (Gas 1 and Gas 2)....................................................................... 7-11 X X
Traceability certificates.................................................................................... 7-12

X X
7-1
7. Solutions and gas mixtures ABL800 FLEX reference manual
General information
In Vitro All the solutions described in this chapter are for in vitro diagnostic use.
T T
Diagnostic Use
Solution Each solution is identified with an "S" and is followed by 4 or 5 digits. The name
numbers of the solution comes after the number.
Gas names The two gas mixtures used by the analyzer are named Gas 1 and Gas 2.
Expiration date The expiration date of a solution found on the label or on a sticker on the side of
the container is stated as a year and month. Do not use a product after its expiration
date.
Safety Data Safety Data Sheets for all solutions are available from your Radiometer distributor.
Sheets
Reordering Information for reordering solutions from Radiometer can be found in the ABL800T
FLEX Operators Manual, Chapter 14. T
7-2
ABL800 FLEX reference manual 7. Solutions and gas mixtures
Calibration solutions
S1820 and Use: For calibration of the pH, electrolyte and metabolite
S1830 electrodes in the ABL835/30/25/20/15/10/05 FLEX
analyzers.
Quantity: 200 mL
Composition: Contains the following substances with the stated nominal
concentrations:
Solution Substance Concentration (mmol/L)
S1820 K+ P 4
+
Na P 145
Ca2+ P 1.25
Cl P
102
cGlu
T T
10
cLac 4
buffer Maintains a pH of 7.40
+
S1830 K P 40
+
Na P 20
Ca2+ P 5
Cl P
50
The exact values are included in the ba code.
T T
Additives: Preservatives and surfactants.

Storage: At 2-25 oC (36-77 oF).
P P P P
Stability: Expiration date and Lot No. are printed on a label.

Stability in use: 4 weeks for S1820
8 weeks for S1830
7-3
Calibration solutions, Continued T T
S1827 Use: For calibration of the pH, electrolyte and metabolite

Calibration electrodes in the ABL837/27/17 FLEX analyzers.
Solution 1
Quantity: 175 mL
concentrations:
cK+
T T P 4 mmol/L
cNa+
TP T P 145 mmol/L
cCa2+
TP T P 1.25 mmol/L
cCl
TP T P
102 mmol/L
cGlu
P 10 mmol/L
cLac 4 mmol/L
cCrea 200 mol/L
The exact values are included in the barcode.
T T

P P P P

Stability in use: 2 weeks
S1837 Use: For calibration of the pH, electrolyte and metabolite

Calibration electrodes in the ABL837/27/17 FLEX analyzers.
Solution 2
Quantity: 140 mL
concentrations:
cK+
T T P 10 mmol/L
cNa+
TP T P 50 mmol/L
cCa2+
TP T P 5 mmol/L
cCl
TP T P
50 mmol/L
cCreatine
TP T 190 mol/L
The exact values are included in the barcode.
T T

P P P P

Stability in use: 2 weeks
7-4
Calibration solutions, ContinuedT T
S7770 tHb Use: For calibration of the cuvette optical path length.
Calibration The calibrated value can be ctHb, ctHb and ctBil, or ctBil
T T T T
Solution depending on the analyzer version.

Quantity: 2 mL
Composition: Salts, a buffer, preservative and a coloring agent.
Storage: Keep in a dark place at 2-25 oC (36-77 oF).
P P P P
After opening the solution must be used at once.
7-5
Rinse and Cleaning solutions
S4980 Rinse Use: For rinsing the liquid transport system after each measurement
Solution or calibration in the ABL835/30/25/20/15/10/05 FLEX
analyzers.
Quantity: 600 mL
Composition: Contains salts, buffer, anticoagulant, preservatives, and
surfactants.
P P P P
Stability: Expiration date and Lot no. are printed on a separate label.
When stored between 2-32 oC (36-90 oF), S4980 is stable for 25
P P P P
months from the date of production, if unopened.
S4987 Rinse Use: For rinsing the liquid transport system after each measurement
Solution or calibration in the ABL837/27/17 FLEX analyzers.
Quantity: 600 mL
Composition: Contains salts, buffer, anticoagulants, preservatives and
surfactants.
P P P P
When stored between 2-32 oC (36-90 oF), S4987 is stable for 25
P P P P
months from the date of production, if unopened.
S8370 Cleaning
Use: For cleaning the liquid transport system automatically or called
Solution
by operator in the ABL835/30/25/20/15/10/05 FLEX analyzers.
Quantity: 200 mL
Composition: Contains salts, buffer, anticoagulant, preservatives and
surfactants.
P P P P
Stability Expiration date and Lot no. are printed on a separate label.
S5370 Cleaning
Use: For adding to the S8370 Cleaning solution.
Additive
Composition: Contains powdered streptokinase.
Storage: At 2-10 C (36-50 F).
The Cleaning Solution with the Cleaning Additive is stable for 2
months in use.
7-6
Rinse and Cleaning solutions, Continued T T
S5370 Cleaning May cause sensitization by inhalation and skin contact. Do not
WARNING/ T
Additive
T
CAUTION: breathe dust. Avoid contact with skin.. Wear suitable gloves. In
(continued)
T
T
case of accident or if you feel unwell, seek medical advice
immediately (show the label where possible). T
S8377 Cleaning Use: For cleaning the measuring system of the ABL837/27/17 FLEX
Met II Solution analyzers and for checking high creatinine level.
Quantity: 100 mL
Composition: Contains: cCrea = 1500 mol/L, salts, buffer, anticoagulants,
T T
preservatives, surfactants and enzyme.

P P P P
Stability Expiration date and Lot no. are printed on a separate label.
The Cleaning Met II Solution is stable for 14 days in use.
WARNING/ Contains streptokinase. May cause allergic reaction.
CAUTION
7-7
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 four prefilled Organic compounds and
electrode electrode jackets per D711 inorganic salts*.
Membrane Box
E788 pCO2 B B 0.6 mL in four prefilled Inorganic salts, buffer,
electrode electrode jackets per D788 hygroscopic compound,
Membrane Box preservative and surfactant.
E799 pO2 B B 0.6 mL in four prefilled Inorganic salts, organic
electrode electrode jackets per D799 compounds, buffer,
E722 K electrode 0.6 mL in four prefilled Organic compounds,
electrode jackets per D722 inorganic salts, buffer, acid
Membrane Box and preservative.
E755 Na electrode 0.6 mL in four prefilled Inorganic salts, organic
electrode jackets per D755 compounds, preservative
Membrane Box and surfactant.
E733 Ca electrode 0.6 mL in four prefilled Inorganic salts, organic
electrode jackets per D733 compounds, buffer,
E744 Cl electrode 0.6 mL in four prefilled Inorganic salts, organic
electrode jackets per D744 compounds, preservative,
Membrane Box surfactant and hygroscopic
products.
E7066 Glucose 0.6 mL in five plastic Buffer, inorganic salts,
electrode capsules to fill the electrode thickening agent,
jackets (four units) per preservative and surfactant.
D7066 Membrane Box
E7077 Lactate 0.6 mL in five plastic Buffer, inorganic salts,
electrode capsules to fill the electrode thickening agent,
jackets (four units) per preservative and surfactant.
D7077 Membrane Box
E8088 and E8089 0.6 mL in five plastic Buffer, inorganic salts,
Crea electrodes capsules to fill the electrode thickening agent,
jackets (four untis) per preservative and surfactant.
D8088 and D8089
Membrane Box
*WARNING/CAUTION: Irritating to eyes, respiratory system and skin. In case of

T T
contact with eyes, rinse immediately with plenty of water and seek medical advice. T
7-8
Electrolyte solutions, Continued T T
Storage
Temperature:
T T Electrolyte solution:
T T
2-25 oC (36-77 oF)

P P P P For glucose electrode
o o
2-10 C (36-50 F)
P P P P For lactate and crea
electrodes
2-32 oC (36-90 oF)
P P P P For all other electrodes
Stability Expiration date and Lot No. are printed on a label on the side of the membrane
box.
7-9
S5362 Hypochlorite Solution
S5362
Use: For protein removal and decontamination according to the
Hypochlorite
procedures described in the Operator's Manual, chapter 4:
Solution
T T
Analyzer Menus and Programs.

T T
Quantity: 100 mL. Delivered with a 1-mL syringe.

Composition: Contains sodium hypochlorite (pH 12).
Storage: Keep in a dark place at 2-8 oC (36-46 oF). After use, keep the
P P P P
bottle tightly capped to avoid contamination and

decomposition.
Stability: Expiration date and Lot No. are printed on a separate label on
the bottle.
7-10
Gas mixtures (Gas 1 and Gas 2)
Use For calibration of the pCO2 and pO2 electrodes.

B B B B
Cylinder types The following types of Gas 1 cylinders are used depending on the geographical
location of the analyzer:
T T
Gas 1 T Gas 2 T
EU USA Japan
Cylinder volume 1L 1L 1L 1L
Gas volume 10 L 33 L 25 L 10 L
Fill pressure 140 psi 500 psi 375 psi 140 psi
at 25 oC
P P (10 bar) (34 bar) (26 bar) (10 bar)
Composition 19.76 % O2, 5.60 % CO2
B B B B
< 0.04 % O2, 11.22 % CO2
B B B B
74.64 % N2 B B
88.78 % N2 B B
WARNING/ Pressurized container. Non-flammable compressed gas. Do not breathe gas. Gas
T
CAUTION: mixtures containing less than 19.5 % oxygen may cause suffocation. Protect from
sunlight and do not expose to temperatures exceeding 50 oC (122 oF). Store and P P P P
use with adequate ventilation. Keep away from oil and grease. Do not refill. T
NOTE:
T T The exact composition of each gas mixture is given in the barcode on the gas
T
cylinder label. The barcode is entered by the barcode reader or manually. T
Stability Gas 1 and Gas 2 are stable for 25 months from the date of filling.
Storage The gas cylinders should be stored between 2-32 oC (36-90 oF). P P P P
7-11
Traceability certificates
7-12
7-13
7-14
7-15
7-16
7-17
7-18
ABL800 FLEX Reference Manual Index
Index
A
ABL837/27/17 performance characteristics .................................................................... 5-72
Absorbance ........................................................................................................................ 3-4
Additional information about FLEXMODE .................................................................... 5-48
Altitude Correction .......................................................................................................... 6-52
Amperometric method ....................................................................................................... 2-2
B
Bias .................................................................................................................................... 5-2
BiasABL chart description ................................................................................................... 5-7
B B
C
Calibration ..................................................................................................................1-3, 2-3
Calibration line .................................................................................................................. 1-4
Calibration materials...................................................................................................1-7, 2-3
Calibration Solutions ......................................................................................................... 7-3
Continuous spectrum ......................................................................................................... 3-5
Contribution to imprecision specifications from HbF correction .................................... 5-96
Conversion of Units ......................................................................................................... 6-49
Correcting for Interferences............................................................................................... 3-7
Correction Factors for Oximetry Parameters and Bilirubin ............................................... 4-4
Corrrection Factors for Electrolyte and Metabolite Parameters......................................... 4-7
Crea electrodes................................................................................................................. 2-23
Calibration material ..................................................................................................... 2-25
Description .................................................................................................................. 2-23
Drift ............................................................................................................................. 2-28
Measurements and corrections .................................................................................... 2-29
Sensitivity.................................................................................................................... 2-26
Sensitivity limits.......................................................................................................... 2-28
Zero current ................................................................................................................. 2-25
ctBil sensitivity for pH changes ....................................................................................... 5-99
T T
D
Default Values ................................................................................................................. 6-51
Defintion of terms.............................................................................................................. 5-2
Derived Parameters.......................................................................................................... 6-17
Determining concentrations ............................................................................................... 3-6
Drift ................................................................................................................................... 1-6
E
Electrolyte electrodes
Calibration solution values .......................................................................................... 1-26
Corrections .................................................................................................................. 1-30
Drift ............................................................................................................................. 1-28
Sensitivity.................................................................................................................... 1-27
Stability criteria ........................................................................................................... 1-35
Status ........................................................................................................................... 1-28
Electrolyte Electrodes ...................................................................................................... 1-23
Electrolyte Solutions.......................................................................................................... 7-8
F
FHbF sensitivity for pH changes ..................................................................................... 5-97
T T
Index ABL800 FLEX Reference Manual
G
Gas Mixtures (Gas 1 and Gas 2) ...................................................................................... 7-11
Glucose and lactate electrodes ......................................................................................... 2-13
Corrections .................................................................................................................. 2-18
Drift ............................................................................................................................. 2-17
Sensitivity.................................................................................................................... 2-16
Zero current ................................................................................................................. 2-14
H
HbF versus HbA ................................................................................................................ 3-7
Hypochlorite Solution...................................................................................................... 7-10
I
Imprecision ........................................................................................................................ 5-3
Imprecision chart ............................................................................................................... 5-8
Input Parameters .............................................................................................................. 6-14
Interference tests
cCrea............................................................................................................................ 5-99
T T
Electrolytes.................................................................................................................. 5-92
Metabolites .................................................................................................................. 5-93
Oximetry parameters ................................................................................................... 5-95
pH/blood gas................................................................................................................ 5-92
L
Lambert-Beers law ........................................................................................................... 3-4
List of Equations.............................................................................................................. 6-28
M
Matrix of constants ............................................................................................................ 3-6
Mean Corpuscular Hemoglobin Concentration
MCHC ......................................................................................................................... 5-97
Measured parameters ..................................................................................................3-2 ,6-5
Measuring time .................................................................................................................. 1-7
N
Nernst equation .........................................................................................................1-2, 1-25
O
Optical System................................................................................................................... 3-2
Oximetry and bilirubin
Measurement and Corrections ....................................................................................... 3-9
Oxyhemoglobin Dissociation Curve (ODC).................................................................... 6-44
P
Parameters
Ranges and limits .......................................................................................................... 6-3
Symbols ......................................................................................................................... 6-2
pCO2 electrode
T T B B
Corrections - blood samples ........................................................................................ 1-18

Corrections - expired air samples ................................................................................ 1-21
Drift ............................................................................................................................. 1-17
Sensitivity.................................................................................................................... 1-17
Status ........................................................................................................................... 1-17
pCO2 Electrode ................................................................................................................ 1-15
T T B B
Performance test results - bilirubin .................................................................................. 5-42

Performance test results cCa2+ ...................................................................................... 5-24
T T P P
Performance test results cCl ........................................................................................ 5-22

T T P P
ABL800 FLEX Reference Manual Index
Performance test results - cCrea....................................................................................... 5-72

T T
Performance test results cGlu ....................................................................................... 5-26

T T
Performance test results cK .......................................................................................... 5-18

T T
Performance test results cLac ....................................................................................... 5-28

T T
Performance test results cNa+ ....................................................................................... 5-20

T T P P
Performance test results ctHb ....................................................................................... 5-30

T T
Performance test results - oximetry ................................................................................. 5-32

Performance test results pCO2 ...................................................................................... 5-12
T T B B
Performance test results - pH........................................................................................... 5-10

Performance test results pO2 ......................................................................................... 5-15
T T B B
pH electrode
Corrections .................................................................................................................. 1-11
Drift ............................................................................................................................. 1-10
Sensitivity.................................................................................................................... 1-10
Status ........................................................................................................................... 1-10
pH Electrode ...................................................................................................................... 1-9
pO2 electrode
T T B B
Corrections - blood samples .......................................................................................... 2-8

Corrections - expired air samples ................................................................................ 2-11
Drift ............................................................................................................................... 2-6
Sensitivity...................................................................................................................... 2-5
Zero point ...................................................................................................................... 2-6
pO2 Electrode..................................................................................................................... 2-4
T T B B
Potentiometric method....................................................................................................... 1-2

R
Reference Electrode........................................................................................................... 1-8
Repeatability ...................................................................................................................... 5-2
Repeatability chart ............................................................................................................. 5-8
Residual spectrum.............................................................................................................. 3-8
Rinse and Cleaning Solutions ............................................................................................ 7-6
S
Sensitivity .......................................................................................................................... 1-5
Status ................................................................................................................................. 1-6
T
Test conditions ABL8X5/8X0 ...............................................................................5-6, 5-50
The Deep Picture ............................................................................................................... 6-2
Total absorbance ................................................................................................................ 3-4
Traceability Certificates................................................................................................... 7-15
U
Units and Numerical Format of Derived Parameters ....................................................... 6-22
Updatings........................................................................................................................... 1-7
User-defined corrections.................................................................................................... 4-2
ABL800 FLEX Reference manual Date of issue
Date of issue
Radiometer representative: Manufacturer:
Radiometer Medical ApS

If you have any questions kandevej 21
or need assistance, 2700 Brnshj
please contact your local Denmark
Radiometer representative. www.radiometer.com
U U
ABL800 FLEX reference manual

- from software version 6.00
Publication: 200801
Edition: F
Code number: 989-963
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Contents

2. Amperometric measuring principles

3. Optical measuring principles

7. Solutions and gas mixtures

Third-party software and trademarks

Warranties and disclaimer

1. Potentiometric measuring principles ............................................................. 1-1

Electrolyte electrodes...................................................................................... 1-23

Glucose and Lactate electrodes....................................................................... 2-13

Performance test results pCO2 ..................................................................... 5-12

Performance test results pO2 ........................................................................ 5-15

Performance test results cNa+ ...................................................................... 5-20

Performance test results cCl ....................................................................... 5-22

Performance test results cGlu ...................................................................... 5-26

Performance test results electrolytes............................................................ 5-54

7. Solutions and gas mixtures ............................................................................. 7-1

and electrolyte electrodes that are based on this principle.

Contents This chapter contains the following topics.

Reference electrode.......................................................................................... 1-8

pH electrode ..................................................................................................... 1-9

pCO2 electrode ................................................................................................. 1-15

Electrolyte electrodes ....................................................................................... 1-23 X X

References ........................................................................................................ 1-37

Reference Electrolyte Electrolyte

between two subsequent calibrations).

applied to determine the activity (ax) of the species under study:

Continued on next page

General information, Continued T T

The Nernst equation is rearranged to express the activity as a function of the

= the activity coefficient of species x under the measurement conditions

of mmoles per kg of solvent. However, molality is converted to concentration

equation is not directly applied.

Continued on next page

General information, Continued T T

functions. Calibration data can therefore be determined by relating the electrode

2) and 100 mV at pH 7.398 (Cal 1)

Continued on next page

General information, Continued T T

The sensitivity of an electrode is calculated as:

where 61.5 = sensitivity of theoretical electrode.

Each electrode has its own sensitivity limits.

Continued on next page

General information, Continued T T

Measured Theoretical calibration line for the A calibration

Each electrode has its own status limits.

Drift Drift of an electrode is a measure of stability obtained by comparing the last

Continued on next page

General information, Continued T T

Calibration The following calibration materials are used:

Calibration Solutions 1 and 2: the exact composition of Calibration of the pH,

each pCO2 measurement; the exact composition of the

calibration solutions is given in the barcode on the bottle

The Chemical Reference Laboratory at Radiometer is responsible for the accuracy

diagram below schematically illustrates the electrode response that is calculated on

Upd. 1 Upd. last

Description The reference electrode is used in the measurement of pH and electrolyte

Electrode contact The electrolyte solution acts as a salt-bridge

with AgCl membrane, thereby obtaining a more stable

The membrane consists of three separate membranes:

Electrode The potential difference across the

equal, the potential difference will theoretically be 0 mV.

Nernst equation can be expressed as:

Designation The following symbols are used:

E(pH,Cal2) = Potential of the pH electrode chain from a calibration