ABL80 Reference Manual - V3.11

ABL80 FLEX reference manual
ABL80 FLEX
reference
manual
What is new in this manual?
Update for This manual has been updated with information on the following:
ABL80 FLEX • Lactate sensor - the BASIC software configuration supports lactate measurement.
with BASIC Specifications for the lactate sensor have been added to this manual. This information
software includes:
configuration
• Performance characteristics of the lactate sensor
version: 3.00
• Dependency of the lactate measurement on the oxygen level in the sample
• Interference substances relevant to the lactate sensor
• Solution pack solutions for use with the lactate sensor
Table of contents
1. Introduction
ABL80 FLEX
analyzer 2. Wet section
3. Electronics
4. Sensors
5. User-defined corrections
Reference manual
6. Performance characteristics
7. Parameters
8. Solutions
9. Interfacing facilities
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 ABL80 FLEX analyzer system comprises the Microsoft Windows XP Embedded Operating
System.
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) 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.
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,
negligence or tort (including strict liability), and even if Radiometer has knowledge of the possibility
of the potential damage or loss.
CONFIDENTIALITY
The contents of this document shall not be reproduced or communicated to any third party without the
prior written consent of Radiometer.
CHANGES
This document is subject to change without notice.

While every effort is made to ensure the correctness of the information provided in this document as
changed from time to time, Radiometer disclaims any liability for errors and omissions.
Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, AQURE, PICO, CLINITUBES and
QUALICHECK are trademarks of or used under license by Radiometer Medical, ApS.
2012 Radiometer Medical ApS, All rights reserved.

Table of contents
Introduction This manual refers to the function of all versions of the ABL80 FLEX analyzer. It
describes how it measures and calibrates, which parameters are reported, and how
the analyzer is tested.
Contents This manual contains the following topics.
ABL80 FLEX documentation.................................................................................. 1-2

Introduction ............................................................................................................. 2-2
Wet section diagram – ABL80 FLEX analyzer ....................................................... 2-3
Wet section diagram – ABL80 FLEX CO-OX analyzer ......................................... 2-5
Measuring processes .............................................................................................. 2-8

General information ................................................................................................. 2-9
Patient samples – ABL80 FLEX analyzer ............................................................. 2-10
Patient samples – ABL80 FLEX CO-OX analyzer ............................................... 2-11
Manual QC samples – ABL80 FLEX analyzer ..................................................... 2-13
Manual QC samples – ABL80 FLEX CO-OX analyzer ........................................ 2-14
Electronic boards and components .......................................................................... 3-3
Overview ................................................................................................................ 4-3

General construction ................................................................................................ 4-3
General measuring principles .................................................................................. 4-4
Potentiometric measuring principle ......................................................................... 4-5
Amperometric measuring principle ......................................................................... 4-7
Conductometric measuring principle ..................................................................... 4-10
Calibration............................................................................................................ 4-12
General information ............................................................................................... 4-13
The calibration equation ........................................................................................ 4-14
Sensor parameter limits ......................................................................................... 4-16
Sensitivity .............................................................................................................. 4-17
Stability – electrical ............................................................................................... 4-18
Stability – temperature........................................................................................... 4-19
Range – electrical .................................................................................................. 4-20
Reference electrode .............................................................................................. 4-21

Background information about the reference electrode ......................................... 4-22
Construction of the reference electrode ................................................................. 4-23
Table of contents ABL80 FLEX reference manual
pH sensor.............................................................................................................. 4-24
Construction of the pH sensor ............................................................................... 4-25
Measuring principle of the pH sensor .................................................................... 4-26
Calibration of the pH sensor .................................................................................. 4-29
Measurement – pH................................................................................................. 4-30
Corrections – pH.................................................................................................... 4-31
pCO2 Sensor ......................................................................................................... 4-32

Construction of the pCO2 sensor ........................................................................... 4-33
Measuring principle of the pCO2 sensor ................................................................ 4-34
Calibration of the pCO2 sensor .............................................................................. 4-38
Measurement – pCO2............................................................................................. 4-40
Corrections – pCO2 ................................................................................................ 4-41
pO2 sensor ............................................................................................................ 4-42

Construction of the pO2 sensor .............................................................................. 4-43
Measuring principle of the pO2 sensor .................................................................. 4-44
Calibration of the pO2 sensor ................................................................................. 4-47
Measurement – pO2 ............................................................................................... 4-48
Corrections – pO2 .................................................................................................. 4-49
The electrolyte sensors ......................................................................................... 4-50

Construction of the electrolyte sensors .................................................................. 4-51
Measuring principle of the electrolyte sensors ...................................................... 4-52
Calibration of the electrolyte sensors..................................................................... 4-54
Measurement – electrolytes ................................................................................... 4-55
Glucose and Lactate sensors ................................................................................ 4-56

Construction of the Glu sensor .............................................................................. 4-57
Measuring principle of the Glu sensor ................................................................... 4-58
Calibration of the Glu sensor ................................................................................. 4-60
Measurement – Glu ............................................................................................... 4-61
Construction of the Lac sensor .............................................................................. 4-62
Measuring principle of the Lac sensor ................................................................... 4-63
Calibration of the Lac sensor ................................................................................. 4-65
Measurement – Lac ............................................................................................... 4-66
Conductivity electrodes........................................................................................ 4-67

Construction of the conductivity electrode ............................................................ 4-68
Measuring principle of the conductivity electrode ................................................ 4-69
Calibration of the conductivity electrode............................................................... 4-71
Measurement – Hct ................................................................................................ 4-73
ABL80 FLEX reference manual Table of contents
Optical System ..................................................................................................... 4-74

Measuring principle ............................................................................................... 4-75
Calibration ............................................................................................................. 4-79
Correcting for HbF interference ............................................................................ 4-80
Correcting for other interferences .......................................................................... 4-82
Measurement and corrections ................................................................................ 4-83
References ............................................................................................................ 4-85

All parameters ......................................................................................................... 5-4
Reference methods ................................................................................................. 6-3

Testing against a reference method ......................................................................... 6-4
Reference methods for the ABL80 FLEX analyzers ............................................... 6-6
Performance tests ................................................................................................... 6-8

Definition of terms................................................................................................... 6-9
Performance test conditions – ABL80 FLEX analyzer ......................................... 6-11
ABL80 FLEX performance test results ................................................................. 6-12
Performance test conditions – ABL80 FLEX CO-OX analyzer ............................ 6-20
ABL80 FLEX CO-OX performance test results .................................................... 6-21
Interference tests .................................................................................................... 6-30
Definitions and symbols......................................................................................... 7-2

Acid-base parameters .............................................................................................. 7-5
Oxygen parameters .................................................................................................. 7-7
Oximetry parameters ............................................................................................. 7-10
Electrolyte/metabolite parameters ......................................................................... 7-11
Units and ranges ................................................................................................... 7-12

Introduction ........................................................................................................... 7-13
Measured parameters ............................................................................................. 7-14
Input Parameters .................................................................................................... 7-16
Derived parameters ................................................................................................ 7-17
Equations.............................................................................................................. 7-21
General information ............................................................................................... 7-22
List of equations .................................................................................................... 7-23
Oxyhemoglobin dissociation curve (ODC) ........................................................... 7-34
Conversion of units ................................................................................................ 7-39
Default values ........................................................................................................ 7-41
iii
Table of contents ABL80 FLEX reference manual
References ............................................................................................................. 7-42

Solutions .................................................................................................................. 8-3
Certificate of traceability ......................................................................................... 8-5
Connecting an alphanumeric keyboard.................................................................... 9-3
Connecting the external barcode scanner ................................................................ 9-4
Connecting to a network .......................................................................................... 9-5
Additional connections ............................................................................................ 9-6
Index
Date of Issue
1. Introduction
Overview This section gives an introduction to the documentation that accompanies all
versions of the ABL80 FLEX analyzer. It describes how this particular manual is
organized and explains the different notices that appear in it.
Contents This chapter contains the following topics.

ABL80 FLEX documentation ................................................................1-2
1. Introduction ABL80 FLEX reference manual
ABL80 FLEX documentation
ABL80 FLEX The documentation that accompanies all ABL80 FLEX analyzers includes
practical and theoretical information regarding the function and use of the
analyzer.
Documentation The table below describes documentation available for this analyzer.
Documentation Description
The operator’s • Contains all the information required for everyday
manual operation of the analyzer.
• Describes the functions of the analyzer and how to set it
up according to customer needs and requirements.
• Explains error messages and gives troubleshooting
procedures.
• Contains ordering information
The reference • Provides detailed information about the operating
manual principles of the analyzer.
• Describes the measuring and calibrating principles.
• Lists all the parameters.
• Provides the equations from which the derived
parameters are calculated.
• Provides information about how the performance of the
analyzer is tested.
1-2
2. Wet section
Introduction This chapter describes the wet section of the ABL80 FLEX and ABL80 FLEX
CO-OX analyzers.

Introduction ............................................................................................2-2
Wet section diagram – ABL80 FLEX analyzer .....................................2-3
Wet section diagram – ABL80 FLEX CO-OX analyzer .......................2-5
Measuring processes ........................................................................................ 2-8
General information ...............................................................................2-9
Patient samples – ABL80 FLEX analyzer ...........................................2-10
Patient samples – ABL80 FLEX CO-OX analyzer..............................2-11
Manual QC samples – ABL80 FLEX analyzer ...................................2-13
Manual QC samples – ABL80 FLEX CO-OX analyzer ......................2-14
2. Wet section ABL80 FLEX reference manual
Introduction
Definition The wet section of the analyzer is where all samples and solutions are transported
for measurement, calibration and rinse.
Contents of wet The main components of the wet section are:

section
• Sensor cassette
• Internal tubing
• Peristaltic pumps for sample aspiration, calibration and waste
• Valve / manifold assembly
• Solution pack
• Hemolyzer (ABL80 FLEX CO-OX analyzer only)
Solutions All solutions for the ABL80 FLEX analyzer (all versions) are contained in the
solution pack.
Gases Gas tanks are not necessary with the ABL80 FLEX analyzer (all versions). The
multiple levels of solutions are tonometered and sealed in gastight disposable
pouches, without a gas phase. This eliminates the need for gas tanks, and
temperature or barometric pressure corrections.
Window A window in the sensor cassette allows the user to view the sample path at the
location of the measuring sensors for pH, blood gas, electrolyte and glucose
measurements.
2-2
ABL80 FLEX reference manual 2. Wet section
Wet section diagram – ABL80 FLEX analyzer
Introduction The wet section of the ABL80 FLEX analyzer is comprised of the following
components:
• Sensor cassette
• Internal tubing, valves, and manifold interface
• Sample pump and waste pump
• Solution pack
Diagram The following is a schematic diagram of the wet section of the ABL80 FLEX
analyzer.
2-3
Parts table The table below describes the functions of the main parts of the ABL80 FLEX wet
section.
Item Part Function

1 Inlet probe The point of introduction for the sample into the
sensor cassette. It also provides a pathway for
calibration/QC solution to be flushed to the waste
drain.
2 Waste drain Receptacle which receives waste fluids from the
inlet probe during flush cycles.
3 Main waste line Internal tubing, which provides the pathway for
waste fluid transport to the waste pouch contained
in the solution pack.
4 Cassette The area of the cassette which contains the sensor
measuring array and where the actual measurements occur.
chamber
5 Roller pump Provides the pumping mechanism to transport fluids
across the cassette sensor array.
6 Cassette luer The fluid connection port between the analyzer and
the sensor cassette.
7 Side waste line Tubing connection that provides a pathway for
excess fluid to be transported to the waste pouch
contained in the solution pack.
8 Waste valve Internal valve that controls the flow of waste fluids
into the waste pouch contained in the solution pack.
9 Waste pump Pump that transports waste fluids to the waste
pouch contained in the solution pack.
10 Valves Internal valves that control the selection and flow of
solutions from the solution pack to the sensor
cassette.
11 Manifold Interface between the solution pack, valves and the
analyzer wet section.
12 Fluid port luer These luers penetrate the valves of the sealed
pouches in the solution pack to provide fluid flow.
13 Solution pack Contains five sealed pouches, four solution pouches
and a waste pouch.
14 Solution pouches Four pouches with precision-tonometered
electrolyte solutions.
15 Waste pouch Pouch to collect and contain all waste fluids in the
system.
2-4
Wet section diagram – ABL80 FLEX CO-OX analyzer
Introduction The wet section of the ABL80 FLEX CO-OX analyzer is comprised of the
following components:
• Sensor cassette
• Internal tubing, valves, and manifold interface
• Sample pump and waste pump
• Solution pack
• Hemolyzer and sample cuvette
Diagram The following is a schematic diagram of the wet section of the ABL80 FLEX
analyzer.
2-5
Parts table The table below describes the functions of the main parts of the ABL80 FLEX wet
section.
Item Part Function

1 Inlet probe The point of introduction for the sample into the
sensor cassette. It also provides a pathway for
calibration/QC solution to be flushed to the waste
drain.
2 Waste drain luer Luer which receives waste fluids from the inlet
probe during flush cycles.
3 Main waste line Internal tubing, which provides the pathway for
waste fluid transport to the waste pouch contained
in the solution pack.
4 Cassette The area of the cassette which contains the sensor
measuring array and where the actual measurements occur for
chamber pH, blood gases, electrolytes and glucose.
5 Cassette luer The fluid connection port between the analyzer and
the sensor cassette.
6 Pinch valve Valve used in the measurement of co-oximeter
parameters
7 Hemolyzer Ultrasonic hemolyzer which contains the hemolyzed
sample in a cuvette during measurement
8 Liquid sensor Senses the location of the sample in the pathway,
ensuring the sample has successfully been
transported through the hemolyzer
9 Spectrometer Uses a photodiode array to measure the wavelengths
of the sample and create an absorption spectrum
10 Sample pump Provides the pumping mechanism to transport fluids
through the hemolyzer and across the cassette
sensor array
11 Vent valve Internal valve that controls the flow of waste fluids
into the waste pouch contained in the solution pack.
12 Waste pump Pump that transports waste fluids to the waste
2-6
Item Part Function

13 Valves Internal valves that control the selection and flow of
solutions from the solution pack to the sensor
cassette
14 Manifold Interface between the solution pack, valves and the
analyzer wet section
15 Fluid port luer These luers penetrate the valves of the sealed
pouches in the solution pack to provide fluid flow.
16 Solution pack Contains five sealed pouches, four solution pouches
and a waste pouch.
17 Solution pouches Four pouches with precision-tonometered
electrolyte solutions and dyes.
18 Waste pouch Pouch to collect and contain all waste fluids in the
system.
2-7
Measuring processes
Introduction This section describes the process that occurs within the analyzer during sample
introduction. The various types of sampling modes are discussed separately.
All processes refer to the wet section diagram on page 2-3.
Contents This section contains the following topics.

General information ................................................................................. 2-9
Patient samples....................................................................................... 2-10
Manual QC samples ............................................................................... 2-13
Analyzer configuration .......................................................................... 2-13
2-8
General information
Prior to When the analyzer is in the Ready mode prior to a measurement, the sensor
measurement cassette contains Solution 1 from the solution pack.
Heating The analyzer temperature is maintained at ambient levels. The sensor cassette
measurement chamber is heated to 37 °C during calibration and sample
measurement only. The measuring chamber achieves 37 °C in approximately 10
seconds (from ambient).
Solutions All necessary solutions contained in the solution pack are introduced automatically
as required into the sensor cassette and hemolyzer via the valve / manifold
assembly.
Waste removal All waste liquids are transported to the waste pouch contained in the solution pack.
This includes blood sample waste. All used solution packs should be considered a
biohazard and handled in an appropriate manner, consistent with your institutional
guidelines.
2-9
Patient samples – ABL80 FLEX analyzer
Measuring The following table describes the analytical process of a blood sample
process measurement with the ABL80 FLEX analyzer.
Stage Description
1. The analyzer is ready to accept a patient sample.
• “Ready” message is displayed
• Traffic light is displaying a green or yellow light
• The desired parameters are available
2. Analysis is selected from the menu.
3. The pump roller wheel rotates counterclockwise approximately 1/20
of a rotation to clear any air at the tip of the inlet probe.
4. The Hct Hemodilution Correlation question box is answered as
necessary by the user (optional screen).
5. At the Aspiration screen, the user lifts the inlet probe. The sample
(syringe or capillary tube) is positioned at the inlet probe and the user
presses the Aspirate button.
6. The roller pump is activated and rotates clockwise to draw the sample
into the measuring chamber. At the same time, the waste pump and
valves are activated to transport residual liquids through the valves,
the side waste line, the main waste line, through the manifold waste
port to the waste pouch contained in the solution pack.
7. Once the roller pump stops, the analyzer beeps to indicate the first
aspiration phase is complete.
8. The user removes the sample, wipes the inlet probe, and lowers the
inlet flap.
9. The roller wheel is activated a second time to complete the
positioning of the sample over the measuring sensors.
10. Measurement of the sample is performed. Concurrent with sample
analysis, the user enters patient information as necessary.
11. When the measurement is completed, the system draws solution 1
from the solution pack, flushing the sample from the measurement
chamber and filling the measurement chamber with solution 1. The
waste pump is also activated to pump the flushed liquid to the waste
12. Sensor measurements are performed on solution 1.
13. Once sample and solution 1 measurements are completed, results are
compared to the Reference Ranges and Critical Limits, as input by the
user. Results are then displayed, stored, and printed (if requested).
2-10
Patient samples – ABL80 FLEX CO-OX analyzer
Measuring The following table describes the analytical process of a blood sample
process measurement with the ABL80 FLEX CO-OX analyzer.
Stage Description
1. The analyzer is ready to accept a patient sample.
• “Ready” message is displayed
• Traffic light is displaying a green or yellow light
• The desired parameters are available
2. Analysis is selected from the menu.
3. Glucose background current is zeroed, if this parameter is active.
4. The roller pump is activated to aspirate a small bolus of air into the
system.
5. At the Aspiration screen, the user raises the inlet probe. The sample
(syringe or capillary tube) is positioned at the inlet probe and the user
presses the Aspirate button.
6. The roller pump is activated, drawing the sample into the sensor
cassette and the hemolyzer. At the same time, the waste pump and
valves are activated to transport residual liquids through the valves,
the side waste line, the main waste line, through the manifold waste
port to the waste pouch contained in the solution pack.
7. Once the roller pump stops, the analyzer beeps to indicate the first
8. The user removes the sample and lowers the inlet probe.
9. A secondary aspiration phase occurs, properly positioning the sample.
This positioning is confirmed by the liquid sensor.
10. The pinch valve closes and the roller wheel turns slightly in the
opposite direction to produce a positive back pressure within the
hemolyzer. This positive pressure eliminates air bubbles and enhances
the hemolyzation process.
11. Measurement of the sample is performed. Concurrent with sample
analysis, the user enters patient information as necessary.
12. When the sample measurement is complete, the roller wheel turns
back again to relieve the back pressure. The pinch valve then opens.
13. The system draws solution 1 from the solution pack, flushing the
sample from the measurement chamber and filling the measurement
chamber with solution 1. The waste pump is also activated to pump
the flushed liquid to the waste pouch contained in the solution pack.
14. Sensor measurements are performed on solution 1 This step is only
performed in the CO-OX software version of the ABL80 FLEX CO-
OX analyzer.
2-11
15. Once sample and solution 1 measurements are completed, results are
compared to the Reference Ranges, Critical Limits and Reportable
Range, as input by the user. Results are then displayed, stored, and
printed (if requested).
2-12
Manual QC samples – ABL80 FLEX analyzer
Measuring The following table describes the analytical process of a manual QC measurement
process with the ABL80 FLEX analyzer using the manual QC option.
Stage Description
1. The analyzer must have a solution pack and sensor cassette installed.
The last calibration performed must have been successful.
2. Manual QC is selected from the menu.
3. The roller pump rotates counterclockwise approximately 1/20 of a
rotation to clear any air at the tip of the inlet probe.
4. • The type of quality control being analyzed is selected
• The QC Temperature question box is answered if necessary
(optional screen) or enter the desired temperature value of the
ampoule
5. At the Aspiration screen, the user lifts the inlet flap and the inlet
probe is immersed in the QC fluid. The user then presses the Aspirate
button.
6. The roller pump is activated and rotates clockwise to aspirate the QC
solution from the ampoule into the sample chamber. At the same
time, the waste pump and valves are activated to transport residual
liquids through the valves, the side waste line, the main waste line,
through the manifold waste port to the waste pouch contained in the
solution pack.
7. Once the roller pump stops, the analyzer will beep to indicate the first
8. The user removes the QC ampoule, wipes the inlet probe, and lowers
the inlet flap.
9. The roller pump is activated a second time to complete the
positioning of the sample over the measuring sensors.
10. Measurement of the sample is performed.
11. When the measurement is completed, the system draws solution 1
from the solution pack, flushing the sample and filling the
measurement chamber with solution 1. The waste pump is also
activated to pump the flushed liquid to the waste pouch contained in
the solution pack.
12. Sensor measurements are performed on solution 1.
13. Once QC sample and solution 1 measurements are completed, results
are compared to acceptable ranges, as input by the user. Results are
then displayed, stored, and printed (if requested).
2-13
Manual QC samples – ABL80 FLEX CO-OX analyzer
Measuring The following table describes the analytical process of a manual QC measurement
process with the ABL80 FLEX CO-OX analyzer using the manual QC option.
Stage Description
1. The analyzer must have a solution pack and sensor cassette installed.
The last calibration performed must have been successful.
2. Manual QC is selected from the menu.
3. The QC Temperature question box is answered if necessary (optional
screen) or enter the desired temperature value of the ampoule
4. Glucose background current is zeroed, if this parameter is active.
5. The roller pump is activated to aspirate a small bolus of air into the
system.
6. At the Aspiration screen, the user raises the inlet probe and the inlet
probe is immersed in the QC fluid. The user then presses the Aspirate
button.
7. The roller pump is activated and rotates clockwise to aspirate the QC
solution from the ampoule into the sensor cassette and hemolyzer. At the
same time, the waste pump and valves are activated to transport residual
liquids through the valves, the side waste line, the main waste line,
through the manifold waste port to the waste pouch contained in the
solution pack.
8. Once the roller pump stops, the analyzer will beep to indicate the first
9. The user removes the QC ampoule and lowers the inlet flap.
10. A secondary aspiration occurs, positioning the sample. Proper position
of the sample is confirmed by the liquid sensor.
11. The pinch valve closes and the roller wheel turns slightly in the opposite
direction to produce a positive back pressure within the hemolyzer.
12. Measurement of the sample is performed.
13. When the measurement is completed, the roller wheel turns back to
relieve the back pressure. The pinch valve then opens.
14. The system draws solution 1 from the solution pack, flushing the sample
and filling the measurement chamber with solution 1. The waste pump is
also activated to pump the flushed liquid to the waste pouch contained in
the solution pack.
15. Sensor measurements are performed on solution 1. This step is only
performed in the CO-OX software version of the ABL80 FLEX CO-OX
analyzer
16. Once QC sample and solution 1 measurements are completed, results are
compared to acceptable ranges, as input by the user. Results are then
displayed, stored, and printed (if requested).
2-14
3. Electronics
Introduction This chapter provides an overview of the electronic system in all versions of the
ABL80 FLEX analyzer.

Electronic boards and components.........................................................3-3
3. Electronics ABL80 FLEX reference manual
General information
General The electronics of all ABL80 FLEX analyzer versions can be subdivided into
information several modules:
• The user interface module which consists of the touch panel and LCD display, a
built-in barcode scanner, a CD-R/RW drive (in analyzers manufactured prior to
2011), and an embedded computer module
• An integrated thermal printer
• Analog electronics for control of the wet section pumps, valves, and sensor
cassette
Communication Communication between an external data management computer and the analyzer
may be achieved via two USB ports, a serial RS232 interface, or Ethernet
connection via the RJ45 interface port.
Electronic The main functions of the analyzer electronics are outlined in the next section.
components
3-2
ABL80 FLEX reference manual 3. Electronics
Electronic boards and components
Introduction The main functions of the analyzer electronics of all ABL80 FLEX analyzer
versions are outlined below.
Power supply Power requirements include a universal power supply with input from 100-240
VAC, 50-60 Hz with a max of 3.0 A. There are three internal DC output levels for
control of the analyzer electronics, which include 5 VDC, 8.0 A max, +12 VDC,
3.0 A max, and –12 VDC, 0.2 A max. The internal battery charger is +16.8 V, 1.8
A max.
Manifold / Valve The manifold with the integrated valves controls the flow of solutions from the
Assembly solution pack to the sensor cassette and the return of waste to the integrated waste
bag in the solution pack. The valves are controlled via commands from the
analyzer analog electronics.
Printer unit The printer unit consists of a micro-thermal printer mechanism along with printer
control electronics.
Analog board The analog board consists of high impedance amplifiers and an integrated analog
to digital converter to acquire sensor signals and transmit those signals to the
analyzer CPU and an integrated microprocessor to control basic analyzer wet
section functions.
CPU An embedded CPU microcontroller runs the software operating system and
software applications.
Compact flash The compact flash is a solid-state hard drive in which all operating system and
software files are stored along with system database files.
CD drive The CD drive is a CD/DVD R/RW combo drive for loading system software files
or downloading system data. Data may be written to CD-R discs only. The CD
drive is only available in analyzers manufactured prior to 2011.
Baseboard The baseboard is a PCB board that provides the electrical interface between the
CPU and the system electronics and peripheral port connections.
CO-OX board The CO-OX board, specific to the ABL80 FLEX CO-OX analyzer, controls all
functions within the CO-oximeter and transmits those signals to the analyzer CPU.
3-3
3. Electronics ABL80 FLEX reference manual
Hemolyzer An ultrasonic hemolyzer, specific to the ABL80 FLEX CO-OX analyzer,

hemolyzes the whole blood sample and provides a cuvette for measuring the
hemolyzed sample. An LED light shines through the sample in the cuvette. After
passing through the sample, this light is then guided to the spectrometer via an
optical fiber.
Spectrometer The spectrometer, specific to the ABL80 FLEX CO-OX analyzer, separates the
light into 138 wavelengths and converts the light signals to currents, creating an
absorption spectrum. This spectrum is sent to the CPU to determine oximetry
parameter values.
3-4
4. Sensors
Introduction This chapter describes the construction, measurement, and calibration principles
for each of the sensors in the ABL80 FLEX analyzer (all versions).
A separate section is included which describes the optical system in the ABL80
FLEX CO-OX analyzer.
General sections covering the background theory used for measurements and
calibrations are also presented here.
Contents This chapter includes the following topics.

Overview ........................................................................................................... 4-3
General construction ..............................................................................4-3
General measuring principles ................................................................4-4
Potentiometric measuring principle .......................................................4-5
Amperometric measuring principle .......................................................4-7
Conductometric measuring principle ...................................................4-10
Calibration ...................................................................................................... 4-12
General information .............................................................................4-13
The calibration equation ......................................................................4-14
Sensor parameter limits........................................................................4-16
Sensitivity ............................................................................................4-17
Stability – electrical .............................................................................4-18
Stability – temperature .........................................................................4-19
Range – electrical .................................................................................4-20
Reference electrode ........................................................................................ 4-21
Background information about the reference electrode .......................4-22
Construction of the reference electrode ...............................................4-23
pH sensor ........................................................................................................ 4-24
Construction of the pH sensor .............................................................4-25
Measuring principle of the pH sensor ..................................................4-26
Calibration of the pH sensor ................................................................4-29
Measurement – pH ...............................................................................4-30
Corrections – pH ..................................................................................4-31
pCO2 Sensor .................................................................................................... 4-32
Construction of the pCO2 sensor..........................................................4-33
Measuring principle of the pCO2 sensor ..............................................4-34
Calibration of the pCO2 sensor ............................................................4-38
Measurement – pCO2 ...........................................................................4-40
4. Sensors ABL80 FLEX reference manual
Corrections – pCO2 ..............................................................................4-41

pO2 sensor ....................................................................................................... 4-42
Construction of the pO2 sensor ............................................................4-43
Measuring principle of the pO2 sensor.................................................4-44
Calibration of the pO2 sensor ...............................................................4-47
Measurement – pO2 ..............................................................................4-48
Corrections – pO2 .................................................................................4-49
The electrolyte sensors ................................................................................... 4-50
Construction of the electrolyte sensors ................................................4-51
Measuring principle of the electrolyte sensors ....................................4-52
Calibration of the electrolyte sensors ..................................................4-54
Measurement – electrolytes .................................................................4-55
Glucose and Lactate sensors ......................................................................... 4-56
Construction of the Glu sensor ............................................................4-57
Measuring principle of the Glu sensor .................................................4-58
Calibration of the Glu sensor ...............................................................4-60
Measurement – Glu ..............................................................................4-61
Construction of the Lac sensor ............................................................4-62
Measuring principle of the Lac sensor .................................................4-63
Calibration of the Lac sensor ...............................................................4-65
Measurement – Lac ..............................................................................4-66
Conductivity electrodes ................................................................................. 4-67
Construction of the conductivity electrode ..........................................4-68
Measuring principle of the conductivity electrode ..............................4-69
Calibration of the conductivity electrode.............................................4-71
Measurement – Hct ..............................................................................4-73
Optical System ................................................................................................ 4-74
Measuring principle .............................................................................4-75
Calibration............................................................................................4-79
Correcting for HbF interference ..........................................................4-80
Correcting for other interferences ........................................................4-82
Measurement and corrections ..............................................................4-83
References ....................................................................................................... 4-85
4-2
ABL80 FLEX reference manual 4. Sensors
Overview
General construction
Sensors In this manual, the term sensor refers to an individual sensor as part of the sensing
array within a sensor cassette. The electrical signal from each sensor is measured
by proprietary analog electronics contained within the analyzer unit.
Diagram The diagram below is a generalized diagram of a sensor from any ABL80 FLEX
analyzer version. More detailed descriptions of the individual sensors are found
under the appropriate sensor titles in this chapter.
1 22
3 44
5
Parts and The following table describes the parts of the diagram shown above.
description
Item Part Description
1 Membrane A thin polymeric film separating the sample from
the sensor
2 Electrolyte A conducting material that provides an electrical
contact between the electrode and the sample.
3 Electrode The point of electrical contact to the electrolyte.
4 Electrical contact The point of electrical contact between the
electrode and the analyzer
5 Electrode base The structural platform on which the electrode is
formed.
4-3
General measuring principles
Introduction There are four different measuring principles employed in sensors in all ABL80
FLEX analyzers.
• Potentiometry: The potential of a sensor chain is recorded using a voltmeter,
and related to the concentration of the sample (the Nernst equation).
• Amperometry: The magnitude of an electrical current flowing through a sensor
chain is proportional to the concentration of the substance being oxidized or
reduced at an electrode in the chain.
• Conductometry: Specific impedance of a sample as measured by two
conducting electrodes held at a constant voltage is directly proportional to the
conductive properties of that sample.
• Spectrophotometry: Light passes through a cuvette containing a hemolyzed
blood sample. The specific wavelengths absorbed and their intensity generates
an absorption spectrum used to calculate oximetry parameters. This measuring
principle is used in the ABL80 FLEX CO-OX analyzer only.
The first three measuring principles are described in detail on the following pages.
Spectrophotometry is described in the section titled Optical System.
Activity vs. Strictly speaking, in potentiometry the potential of a sensor chain is related to the
concentration activity of a substance, and not its concentration.
The activity of a substance can be considered as the ‘effective concentration’ of a
species, taking non-ideality of the medium into account.
Activity and concentration are related by the following equation:
a x = γ cx
where:
ax = the activity of the species x
γ = the activity coefficient of species x under the measurement conditions
(for ideal systems γ = 1)
cx = the concentration of species x (mol/L)
NOTE: To be exact, activity is related to the molality of species x, i.e., the
number of mol/kg of solvent. However molality is converted to
concentration (molarity).
Conversion of All ABL80 FLEX analyzers automatically convert activities into concentrations.
activity to The term concentration is therefore used in explanations of the measuring
concentration principles for each of the sensors further on in this chapter.
4-4
Potentiometric measuring principle
Introduction This section describes the principle behind potentiometric measurements, where
the potential of an electrode chain recorded at a voltmeter is related to the
concentration of a substance via the Nernst equation.
Electrode chain An electrode chain describes an electrical circuit consisting of a sample, electrode,
reference electrode, voltmeter, membranes, and electrolyte solutions.
Diagram The diagram below is a general representation of an electrode chain:
Parts and The following table labels the parts of the diagram shown above.
description
Item Part
1 Voltmeter
2 Reference electrode
3 Electrolyte
4 Liquid junction
5 Sample
6 Membrane
7 Measuring electrode
Electrode chain Every element in the electrode chain contributes a voltage to the total potential
potential drop through the chain. Thus:
• When immersed in the appropriate electrolyte solution, both electrodes exhibit
separate potentials.
4-5
• The membrane junctions between the sample and electrolyte solutions also
exhibit separate potentials.
The complete electrode chain potential therefore, is the sum of these separate
potentials and is the quantity measured by the voltmeter.
Determining the By setting up the electrode chain such that all but one of the potentials are constant
potentials and known, the final unknown potential (Esample) can be calculated knowing the
total electrode chain potential (Etotal) and the standard potential (E0).
Etotal = E0 + Esample
Nernst equation Having measured the unknown potential (Esample), the Nernst equation is then
applied to determine the activity (ax) of the species under study:
RT
E sample = E 0 + ln a x
nF
where:
E0 = standard potential of the electrode chain
R = gas constant (8.3143 J/°K-mole)
T = absolute temperature (°K)
n = charge on the species x
F = Faraday constant (96487 C/mole)
ax = activity of the species x
Activity Activity expresses the ‘effective concentration’ of a species and is explained in

more detail in the section General Measuring Principles on page 4-4.
Concentration 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
other quantities on the right hand side of the equation are already known. Finally
the analyzer converts activity to concentration, as explained previously.
Application The potentiometric measuring principle is applied in the pH, pCO2, and electrolyte
sensors. It is slightly different for the pCO2 sensor; however, since the Nernst
equation is not directly applied.
4-6
Amperometric measuring principle
Introduction This section describes the principle behind amperometric measurements in which
the magnitude of an electrical current flowing through an electrode chain is related
to the concentration of a substance being oxidized or reduced at an electrode in the
chain.
Electrode chain The electrode chain in amperometric measurements describes the electrical circuit
that consists of the sample, the two electrodes (anode and cathode), an ammeter, a
voltage source, the membranes, and the electrolyte solutions.
4-7
Diagram The diagram below is a general representation of an amperometric electrode chain

employed in all ABL80 FLEX analyzer versions.
Parts and The following table describes the functions of the parts of the diagram above.
functions
A full account of the measuring process is given after the table.

1 Ammeter Measures the current flowing through the circuit in
nano-amperes.
2 Cathode Negative electrode where a reduction reaction occurs
and electrons are consumed
3 Membrane Allows the appropriate molecules to pass through
from the sample
4 Sample Contacts the membrane
5 Electrolyte Provides electrical contact between the anode and
cathode.
6 Anode Positive electrode where an oxidation reaction occurs
and electrons are released.
7 Applied voltage Applies the necessary potential for the reduction or
oxidation reaction under study.
4-8
Measuring The following is an account of the measuring process in an amperometric

process electrode.
Assumptions
To simplify the explanation it is assumed that:
• There is a species A in the sample, which is reduced at the cathode to A−.
• There is a species X in the electrolyte, which is oxidized at the anode to X+.
Step Action
Transport of A The membrane allows access of species A while
through the restricting access of large polar molecules present in the
membrane sample.
Application of An appropriate potential is applied across the electrodes.
potential
Reduction of A At this applied potential the species A is reduced at the
cathode according to the following reaction:
A + e− → A−
Measurement of The reduction of A produces a flow of electrons and
current therefore an electrical current. The magnitude of this
current is measured.
Oxidation of X To complete the electrical circuit an oxidation reaction
where electrons are released is necessary. Therefore
species X is oxidized according to the following reaction:
X → X + + e−
Calculation of cA 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 thereby automatically calculates the
concentration of A in the sample.
Application The amperometric measuring principle is applied in the pO2, Glu and Lac sensors.
4-9
Conductometric measuring principle
Introduction This section describes the principle behind conductometric measurements, where
the specific impedance between two conducting electrodes is proportional to the
conductive properties of that sample.
Electrical The electrical circuitry includes dual conductivity electrodes, a sample positioned
chain between these sensors, and a source of current.
Vin
I
where
Vin (voltage in) = alternating current at 10 kHz
4-10
Diagram The diagram below is a general representation of a conductometric electrode

chain employed in all ABL80 FLEX analyzer versions.
description
1 RF Fixed resistance in the electrode chain
2 Vin Applied voltage
3 Rs Variable impedance of the sample
4 Vout Output voltage
6 Sample Substance being measured
When RF = RS then:
RF
Vout = ½ Vin or Vout = ∗ Vin
R F + RS
Description The system applies an alternating voltage between the two electrodes at a
frequency of 10 kHz. The current measured through the sample is converted into
an analog-to-digital (A/D) signal.
Application The conductometric measuring principle is applied in the Hct electrodes and the
air-in-sample detection (SC) electrodes.
4-11
Calibration
Introduction This section describes the theory behind the calibration process and the method
used to monitor the calibration.

General information ............................................................................... 4-13
The calibration equation ........................................................................ 4-14
Sensor parameter limits.......................................................................... 4-16
Sensitivity .............................................................................................. 4-17
Stability – electrical ............................................................................... 4-18
Stability – temperature ........................................................................... 4-19
4-12
General information
Definition Calibration is the process that relates the electrode signals during the calibration
sequence to the values of the calibrating solutions. Calibration enables the
electrode signals to be converted to the accurate values for an unknown sample.
Frequency Calibration must be performed at regular intervals so that normal variations in

sensor output can be compensated for after inevitable minor changes in the
sensor’s behavior.
Calibration Calibration of all sensors is performed using calibration solutions 1 through 4 (see
solutions Chapter 8 - Solutions for more information about these solutions).
The calibration solutions contain known concentrations of the substrates to be
measured. These concentrations are vital in determining the measurement accuracy
of the analyzer.
The concentration of each substance in the calibration solutions is programmed
into the integrated smart chip of the solution pack. The information is
automatically read by the analyzer when a solution pack is installed onto the
analyzer.
Traceability of The traceability certificate for these calibration solutions are presented in
calibration Chapter 8 of this manual.
solutions
4-13
The calibration equation
Definition The calibration equation expresses the relationship between the electrical
measurement at a sensor, and the concentration of the substrate specific to the
sensor.
Use The calibration line forms the basis of the scale used by the analyzer to convert
electrical measurements to concentrations.
Deriving the Each sensor has a unique calibration equation.

calibration line In the following example of a potentiometric sensor, the pH sensor is used to
illustrate how this equation is derived from two solutions of known pH. The pH
value as graphed is a linear scale. All other electrolyte values, if graphed, would be
expressed as log10(aion).
• Solution 1 (s1) has a pH of 7.40, which gives a potential reading of 2.3 mV.
• Solution 2 (s2) has a pH of 7.03, which gives a potential reading of 20.4 mV.
These two values are plotted on a graph.
The relationship between potential and pH is linear so a line can be drawn
between the two points, as shown in the diagram below:
Scale The calibration line now forms the scale used to convert the potential measured at
the pH sensor during sample analysis to an actual pH value.
Sample A blood sample gives a potential reading of 4.8 mV at the pH sensor. Reading off
measurements from the calibration line shown below, this potential corresponds to a pH of 7.35.
4-14
Updating The calibration line slope is re-established with every calibration.
Drift Drift describes the variation in location of the calibration line between consecutive
calibrations. Any drift (offset) that occurs in the system is corrected at the time of
analysis by measurement of solution 1.
Sensitivity The slope of the calibration line is described by the sensitivity value.
4-15
Sensor parameter limits
Sensor All parameters are calibrated via a two-point calibration measurement. The
parameter limits electrical response and resulting sensitivity value for each sensor are compared to
the acceptance criteria for that sensor. Any resulting error for a particular sensor
will only affect the sensor in question.
In all ABL80 FLEX analyzer versions the following parameters are checked:
• Sensitivity
• Stability – Electrical
• Stability – Temperature
• Range – Electrical
The equations that are used to calculate these sensor parameters are described in
the following sections under each sensor type.
4-16
Sensitivity
Definition Sensor sensitivity describes the slope of the calibration line derived from a 2-point
calibration.
Limits The sensitivity limits for the calibration are set for each sensor.
The following table lists the sensitivity limits for each sensor:
Parameter Sensitivity Range Unit

pH 40.0 – 65.0 mV/pH unit
CO2 30.0 – 75.0 mV/decade pCO2
O2 0.002 – 0.052 nA/mmHg
Na+ 40.0 – 85.0 mV/decade [Na+]
Ca2+ 20.0 – 45.0 mV/decade [Ca2+]
K+ 40.0 – 70.0 mV/decade [K+]
Cl– 30.0 – 65.0 mV/decade [Cl–]
Hct 50.0 – 300.0 mV/mS
Glu 0.20 – 1.40 nA/mmol/L
Lac 0.25 – 1.59 nA/mmol/L
NOTE: One decade is a 10 fold change in the activity level.
System If the sensitivity of any sensor falls outside the allowed range, an error message
messages appears on the screen, listing the failed sensor. The printout will also reference the
out of range sensor with an up or down arrow adjacent to a sensor sensitivity result
to signify it is out of range. A complete list of sensors whose calibration
sensitivities are out of range for a particular calibration, are also listed on the
calibration printout. Sample analysis will be disabled until a subsequent
calibration is successful or the failed parameter is inactivated.
4-17
Stability – electrical
Definition The electrical stability of each measurement channel is monitored during sample
analysis, calibration/QC event, and manual QC.
Limits After a specified time period, stability criterion is applied for each parameter. The
average of the delta value between n electrical data points is compared to the
stability criterion and is considered satisfactory when the average value is less than
or equal to the criterion for each parameter.
System If any parameter channel fails to satisfy the stability criterion, a “No End Point”
messages error message (N/E) will be displayed on the screen. Results for that parameter
will not be reported.
4-18
Stability – temperature
Definition The temperature of the sensor cassette measuring chamber is maintained at

37.0 °C during sample analysis, System Cycles and manual QC.
Limits The temperature stability limit during measurement and calibration is

37.0 ± 0.2 °C.
System If the temperature of the sensor cassette measuring chamber falls outside the
messages allowed limits during analysis or calibration, the error message “Temp Not Stable”
will be displayed on the screen and printout. Results will not be reported.
4-19
Range – electrical
Definition There is a fixed response range for each sensor electrical circuit.
Limits The response range limit for each sensor circuit is defined in the following table:
Sensor Response Range

pH -150 to +350 mV
CO2 -150 to +350 mV
O2 0 to 20 nA
+
Na -150 to +350 mV
+
K -150 to +350 mV
Ca2+ -150 to +350 mV
Cl– -150 to +350 mV
Hct 0 to 4096 AD
Glu 0 to 100 nA
Lac 0 to 100 nA
System If a sensor measurement signal is outside the electrical response range, the system
messages displays ### for that sensor result.
4-20
Reference electrode
Introduction This section provides information on the construction and operation of the
reference electrode.

Background information about the reference electrode ......................... 4-22
Construction of the reference electrode ................................................. 4-23
4-21
Background information about the reference electrode
Purpose The purpose of the reference electrode is to provide a stable, fixed potential
against which other potential differences can be measured.
The potential at the reference electrode is not altered by sample composition.
Fixed potential A fixed potential is maintained at the reference electrode by the following
equilibrium reactions:
AgCl ⇔ Ag+ + Cl−
Ag+ + e− ⇔ Ag
These reactions are possible because the electrode is constructed of silver / silver
chloride.
Use The reference electrode is used in the measurement of pH, pCO2, and electrolyte
concentrations.
Location The reference electrode is located at the top of the sensor cassette flowcell.
Contact with the sample is made via a small liquid junction between the reference
electrode channel and the measurement chamber.
description
1 Reference Provides the electrical connection to the
electrode voltmeter
2 Hydrogel Reference sensor electrolyte, which provides a
constant internal potential
3 Liquid junction Point of contact between the reference sensor
and the sample
4-22
Construction of the reference electrode
Diagram The following is a schematic diagram of the reference electrode used in all ABL80
FLEX analyzer versions.
11 22
3
3 44
5
Parts and The table below describes the parts of the reference electrode.
functions
1 Liquid junction The physical point of contact between the
hydrogel and the sample.
2 Hydrogel The electrolyte solution. It provides an
electrical contact between the electrode and
the sample.
3 Electrode Ag/AgCl material, which provides the contact
between the hydrogel and the electrical
contact.
electrode and the analyzer.
5 Electrode base The structural platform on which the electrode
is formed.
4-23
pH sensor
Introduction This section describes the construction of the pH sensor, how pH is measured, and
how the sensor is calibrated.

Construction of the pH sensor ............................................................... 4-25
Measuring principle of the pH sensor .................................................... 4-26
Calibration of the pH sensor .................................................................. 4-29
Measurement – pH ................................................................................. 4-30
Corrections – pH .................................................................................... 4-31
4-24
Construction of the pH sensor
Description The pH sensor is of solid-state design with a pH sensitive PVC membrane and an
electrode.
Diagram The following is a diagram of the pH sensor.
1 22
3 44
5
Parts and The table below describes parts of the pH sensor.

description
1 Membrane Ion-selective membrane separating the sample
from the sensor. It is sensitive to H+ ions.
2 Electrolyte A solid-state material, which provides a
constant internal potential and an electrical
connection between the membrane and the
electrode.
3 Electrode The point of electrical contact with the
electrolyte.
5 Electrode base The structural platform on which the electrode
is formed.
Location within The diagram below illustrates the location of the pH sensor within the cassette
sensor array sensor array.
4-25
Measuring principle of the pH sensor
Introduction This section describes the theory behind the measuring principle of the pH sensor.
Electrode chain
The electrode chain (or electrical circuit) set up to measure pH is illustrated in the
following diagram:
Parts and The table below describes the functions of the parts of the diagram above parts.
description
Item Part Function
1 Voltmeter Measures the voltage potential in the circuit
2 Reference electrode Provides electrical connection to the voltmeter
3 Electrolyte Provides a constant internal potential
4 Liquid junction Point of contact between the Reference sensor
and the sample
5 Sample The unknown liquid being measured
6 Membrane An ion-sensitive membrane, which is sensitive
to H+ ions.
7 Electrode Provides electrical connection to the voltmeter
4-26
Electrode chain The total potential across the electrode chain is the sum of the potential
potential differences at each of the elements in the chain, all but one of which is known and
constant, as outlined in the following table.
Element Potential Symbol

Reference electrode Known and constant when the Eref
Ag/AgCl is immersed in the
electrolyte solution
Liquid junction between the Known and constant. Independent ELJ
electrolyte solution in the of sample composition
reference electrode and the
sample
pH-sensitive membrane Unknown. Dependent on sample ESample
separating the sample and the composition
pH sensor
pH electrode Known and constant EE
Total potential Measured by the voltmeter Etot
Unknown The unknown potential difference across the pH-sensitive PVC membrane is the
potential difference between the measured total potential and the sum of the known
potentials:
E sample = E total −(E ref + E LJ + E E )
pH-sensitive The potential difference across the membrane arises as a consequence of a change
membrane in the charge balance at the membrane.
The membrane is sensitive to H+ ions in that it has a H+ ion exchange ability. Since
the internal solid-state reference electrode fixes the internal potential, changes in
the external charging of the membrane produce measurable changes in the overall
potential.
Nernst equation The potential difference across the membrane in the pH sensor can be expressed
by the Nernst equation:
RT
E sample =E 0 + × ln a H +
nF
where:
E0 = Standard electrode potential
R = Gas constant (8.3143 J/°K-mole)
T = Absolute temperature (°K)
n = Charge on the ion
F = Faraday constant (96487 C/mole)
4-27
aH +
= Activity of H+
The theoretical sensitivity of the pH electrode at 37 °C being equal to −61.5 mV

per pH unit, using pH = −log a H the Nernst equation can be expressed as:
+
E sample = E 0 − 615
. × pH mV
Activity and As shown in the equation above for H+, measuring the potential of each of the
concentration electrode chains gives a reading of the activity of the ions in the sample.
The activity of the ions is automatically converted to a concentration value by the
analyzer.
The relationship between activity and concentration is explained in the section
General Measuring Principles at the beginning of this chapter.
4-28
Calibration of the pH sensor
Introduction The pH sensor is calibrated by determining the E0 and sensitivity from 2-point
calibrations. Slight variations in sensor performance between calibrations are
addressed by performing a measurement of the Cal1 solution within every sample
measurement process.
2-Point A 2-point calibration is performed at preset intervals using two solutions from the
calibration solution pack. The precise values for these solutions are contained in the smart
chip located on the solution pack.
Calibration The pH values for all solutions used in calibration are as follows:
levels
• Solution 1 has an approximate pH value of 7.40
The solution pH values are known and contained in the solution pack smart chip.
Sensitivity The sensitivity of the pH electrode (SpH) is obtained from the calibration equation
arising from a 2-point calibration using two solutions, and is calculated from the
following equation:
Sol 2
(mVpH − mVpH
Sol 1
)
SpH = −
(pH Sol 2 − pH Sol 1 )
where:
mV Sol 2 = Potential of the pH electrode chain from a cal measurement on
pH
solution 2
mV Sol 1 = Potential of the pH electrode chain from a cal measurement on
pH
solution 1.
pHSol 1 = Specific pH of solution 1
Sensitivity limits The sensitivity of the pH electrode is between 40 – 65.0 mV/pH units.
4-29
Measurement – pH
Measurement The pH value measured from the sample is calculated as follows:

(mVSol 1 − mVSample )
pH sample = pH Sol 1 +
SpH
mVSol 1 = Potential of the pH electrode chain from a calibration
measurement on solution 1
mVSample = Potential of the pH electrode chain from a cal measurement on
the sample
4-30
Corrections – pH
Temperature The measured pH value can be corrected to reflect the patient’s body temperature
using the following relationship:
pH(T) = pH – (0.0146 + 0.0065x(pH – 7.40))x(T – 37) [1]

where:
pH = Measured pH value of the sample
pH(T) = Temperature-corrected pH value of the sample.
T = Patient’s temperature in °C
4-31
pCO2 Sensor
Introduction This section describes the construction of the pCO2 sensor, how pCO2 is measured,
and how the sensor is calibrated.

Construction of the pCO2 sensor............................................................ 4-33
Measuring principle of the pCO2 sensor ................................................ 4-34
Calibration of the pCO2 sensor .............................................................. 4-38
Measurement – pCO2 ............................................................................ 4-40
Corrections – pCO2 ............................................................................... 4-41
4-32
Construction of the pCO2 sensor
Basic The pCO2 sensor consists of a pH sensitive membrane, electrolyte, and a silver /
description silver chloride electrode.
Diagram The following is a diagram of the pCO2 sensor.
Parts and The table below describes the parts of the pCO2 sensor.
description
1 Membrane A pH sensitive membrane separating the sample
from the sensor.
2 Electrolyte A solution that provides an electrical contact
between the sample and the electrode.
3 Electrode Ag/AgCl material, which provides the contact
between the electrolyte and the electrical contact.
formed.
Location within The diagram below illustrates the location of the CO2 sensor within the cassette
4-33
Measuring principle of the pCO2 sensor
Introduction This section describes the theory behind the measuring principle of the pCO2
sensor.
Electrode chain The electrode chain or (electrical circuit) set up to measure pCO2 is illustrated in
the following diagram:
Parts and The table below describes the functions of the parts of the diagram above.
description
1 Voltmeter Measures the voltage potential in the
circuit
2 Ag/AgCl (Reference) Provides electrical connection to the
electrode voltmeter
3 Hydrogel solution Provides a constant environment to
maintain a constant potential at the
reference sensor
4 Sample The unknown liquid being measured
5 pH sensitive membrane An ion sensitive membrane which is
sensitive to H+ ions and allows for the
exchange of pCO2
6 Electrolyte solution Medium for connection
7 Ag/AgCl electrode Provides the electrical connection to the
voltmeter
4-34
Electrode chain The potential differences at all the junctions in the electrode chain are known and
potential constant, except that at the pH-sensitive membrane. (See the section pH Sensor for
a full explanation.)
The potential difference at the pH-sensitive membrane depends on the pH of the
electrolyte solution, which in turn depends on the CO2 content of the sample. This
is explained in the measuring process below.
Measuring The following is an account of the measuring process in the pCO2 sensor.
process
Part Function
Transport of CO2 CO2 from the sample permeates the membrane.
Dissolution of The CO2 dissolves in the electrolyte solution.
CO2
This produces carbonic acid:
H2O + CO2 ⇔ H2CO3
Dissociation of Carbonic acid dissociates according to the following
carbonic acid equilibrium reaction:
H2CO3 ⇔ H+ + HCO3–
pH change The release of H+ ions changes the H+ concentration, and
therefore the pH of the inner buffer solution on one side of
the pH-sensitive membrane.
Measurement of The concentration gradient of H+ ions across the
potential membrane creates a potential difference across the
membrane.
This change in potential across the membrane is measured
by the voltmeter.
4-35
Part Function
Relation of pH to The pH value is related to the partial pressure of CO2 in
pCO2 the sample by the following equation:
pH = pK a + log
[
HCO 3- ]
α * pCO2
where:
pK a = −log Ka, the equilibrium constant for the
dissociation of carbonic acid in water
α = solubility coefficient for CO2 in water
The structure of the pCO2 sensor is similar to the pH
sensor including the presence of a pH sensitive membrane.
The major difference is in the internal electrolyte solution
present in the pCO2 sensor which allows for the
dissolution and ultimate dissociation of carbonic acid
mentioned above.
A general equation which describes the electrical potential
(E) of both the pH and pCO2 sensors is illustrated in the
following equation:
RT  a Hsample
+ 

E=k+ ln
F  a H+ 
 internal 
In the pH sensor, the only variable in the above equation is
the concentration of H+ in the sample  a H +  .
 sample 
In the pCO2 sensor, however, this one equation contains

two variables. Not only is the H+ concentration in the
sample unknown, but the H+ concentration in the internal
sensor is a variable. This variable is dependent on the
amount of CO2 dissolved into the electrolyte solution.
There is an equilibrium condition which occurs due to the
dissolution of CO2 into water which can be expressed
using the Henderson-Hasselbalch equation:
[HCO 3− ][H + ] [HCO 3− ][H + ]
K= =
[CO 2 ] α * pCO 2
Inserting the Henderson-Hasselbalch equation into the
general equation above results in the following:
E=k+
RT  a Hsample
ln
F  a H+
+ 
 F
(
 = k + RT ln a +
H
)−
RT  [HCO 3− ]
ln
F  α * pCO 2




sample
 internal 
4-36
Part Function
Determination of With cHCO3– held constant (which occurs due to the high
pCO2 concentration of bicarbonate in the internal electrolyte
solution) it can be seen that the electrical potential of the
pCO2 sensor is determined both by the pH of the sample
and the pCO2 of the sample.
The pH of the sample is determined during calibration and
analysis by the pH sensor. This value is measured
simultaneously along with the pCO2 sensor measurement
to result in a final pCO2 value.
4-37
Calibration of the pCO2 sensor
Introduction The pCO2 sensor is calibrated by determining the sensitivity from 2-point
calibrations. Calibration measurements are performed on two levels of
tonometered solution to known CO2 values. Performance of the sensor from
calibration to calibration is evaluated and any drift corrected for during sample or
quality control analysis.
Calibration All ABL80 FLEX analyzer versions are equipped with a solution pack. This pack
levels contains precision-tonometered fluids. The tonometry calibration gas mixture is of
a known composition.
Gas 1 has a composition of: O2 ≈ 25 %
CO2 ≈ 8%
N2 = Balance
Gas 2 has a composition of: O2 ≈ 24 %

CO2 ≈ 15.5 %
N2 = Balance
Gas 3 has a composition of: O2 ≈ 0%

CO2 ≈ 3%
N2 = Balance
As discussed in the previous section, the determination of pCO2 is also dependent

on the pH values.
The partial pressure of CO2 (pCO2) and the solution pH values are known and
contained in the solution pack smart chip.
4-38
Sensitivity The relative sensitivity of the pCO2 sensor (S pCO 2 ) is obtained from the
calibration line arising from a 2-point calibration using solution 1 and solution 2
from the solution pack. The value is calculated from the following equation:
61.0 × ∆mVpH − SpH × ∆mVpCO 2
S pCO 2 =
 pCO 2Cal2 
SpH × log10  
 p CO 2Cal1 
where
∆mVpH = mVpH
Cal2
− mVpH
Cal1
∆mVpCO 2 = mVpCal2
CO 2 − mV pCO 2
Cal1
SpH = sensitivity of pH sensor
Sensitivity limits The sensitivity limits of the pCO2 sensor are 30 – 75.0 mV/decade pCO2.
4-39
Measurement – pCO2
Measurement The pCO2 value for a sample is calculated from the following equation:
61.0×∆mVpH +SpH ×∆mVpCO 2

SpH ×S pCO 2
pCO 2 = pCO 2 Sol1 × 10 mmHg
4-40
Corrections – pCO2
Temperature The pCO2 measured on a sample can be corrected to reflect the patient’s body
temperature using the following equation:
pCO 2 (T ) = pCO 2 ×10 ( 0.021×(T −37 )) mmHg [1]
where:
pCO2(T) =Temperature-corrected value of the sample.

pCO2 = Measured pCO2 value of the sample
4-41
pO2 sensor
Introduction This section describes the construction of the pO2 sensor, how pO2 is measured,
and how the sensor is calibrated.

Construction of the pO2 sensor .............................................................. 4-43
Measuring principle of the pO2 sensor................................................... 4-44
Calibration of the pO2 sensor ................................................................. 4-47
Measurement – pO2 ............................................................................... 4-48
Corrections – pO2 .................................................................................. 4-49
4-42
Construction of the pO2 sensor
Basic The pO2 sensor consists of a silver anode and a gold cathode surrounded by an
description electrolyte solution and oxygen permeable membrane.
Diagram The following is a diagram of the pO2 sensor.
11 22
33 44
55
6
Parts and The table below describes the parts of the pO2 sensor.
description
1 Membrane A thin film, permeable to O2, which allows
diffusion of oxygen to the cathode.
2 Electrolyte A buffered phosphate solution. It provides an
electrical contact between the cathode and anode
as well as the necessary ions for the
electrochemical process.
3 Cathode A high purity gold electrode where oxygen is
reduced.
4 Anode A silver electrode where oxidation occurs.
5 Electrical contacts The point of electrical contact between the two
electrodes and the analyzer.
formed.
Location within The diagram below illustrates the location of the O2 sensor within the cassette
4-43
Measuring principle of the pO2 sensor
Introduction This section describes the theory behind the measuring principles of the pO2
sensor.
Electrode chain The electrode chain (or electrical circuit) set up to measure pO2 is illustrated in the
following diagram:
functions
A full account of the measuring process is given after the table.

1 Ammeter Measures the current flowing through the circuit in
amperes.
2 Cathode Gold cathode where O2 is reduced
3 Membrane Oxygen permeable membrane that allows O2 to be
transported from the sample to the cathode.
4 Sample Contacts the sensor’s membrane.
5 Electrolyte Provides electrical contact between the anode and
solution cathode.
Contains a buffer to maintain a constant pH.
Contains Cl– ions to remove Ag+ ions from solution.
6 Anode Silver anode where oxidation takes place
7 Applied voltage Applies the necessary potential for reducing O2.
4-44
Measuring The following is an account of the measuring process in the pO2 sensor.
process
Part Function
Transport of O2 O2 dissolved in the sample permeates the membrane.
Application of A potential of –700 mV is applied to the electrode chain.

potential
Reduction of O2 At this potential O2 is reduced at the cathode (electrons are
consumed) according to the following equation:
O2 + 4H+ + 4e− → 2H2O
The H+ ions come from the electrolyte solution.
This represents the complete reduction of O2. Some of the
O2 however is only partially reduced according to the
following equation:
O2 + 2H+ + 2e– → H2O2
Decomposition of The decomposition reaction of H2O2 produces water and

H 2O 2 oxygen:
2H2O2 → 2H2O + O2
This oxygen is then also reduced at the cathode. In this way
all the oxygen from the sample gets completely reduced.
Measurement of The reduction of oxygen produces a flow of electrons and

current therefore an electrical current. The size of this current, I, is
proportional to the amount of oxygen:
I = S pO 2 × p O 2 + I 0 nA
where:
S pO2 = Sensitivity of the pO2 sensor (see the section
Calibration of the pO2 for an explanation of this
parameter)
pO2 = Partial pressure of O2 in the sample
Io = Zero current i.e. the current flowing through the
circuit when pO2 = 0 mmHg
This current is measured by the ammeter.
4-45
Part Function
Oxidation of Ag To complete the electrical circuit an oxidation reaction
where electrons are released is necessary. This reaction
which occurs at the silver anode is the conversion of Ag to
Ag+:
Ag → Ag+ + e−
In order to maintain a charge balance between the anode
and cathode, 4 atoms of Ag need to be oxidized for one
molecule of O2 to be reduced.
Removal of Ag+ The Ag+ ions are released into the electrolyte solution
where they react with the Cl− ions present, producing AgCl
which is insoluble and forms a layer on the silver surface:
Ag+ + Cl− → AgCl
4-46
Calibration of the pO2 sensor
Introduction The pO2 sensor is calibrated to determine its sensitivity by measuring one
calibration point during a 2-point calibration process. Performance of the sensor
from calibration to calibration is evaluated and any drift corrected for during
sample or quality control analysis.
Calibration All ABL80 FLEX analyzer versions are equipped with a solution pack, which
levels contains precision-tonometered fluids. The tonometry calibration gas mixture is of
a known composition.
Gas 1 has a composition of:
O2 ≈ 25 %
The balance consists of carbon dioxide and nitrogen.
The partial pressure of O2 (pO2) is known and is contained in the solution pack
smart chip.
Sensitivity The sensitivity of the pO2 sensor, S pO2 , is obtained from the calibration equation
that arises during a 2-point calibration. Due to the design of the sensor, the zero
point is a constant and stable known value, therefore requiring only one measured
calibration point for a sensitivity calculation.
The sensitivity value is calculated from the following equation:
nAmp Cal1
S pO 2 =
pO2
pO 2Cal1
Sensitivity limits The sensitivity limits of the pO2 sensor are 0.002 – 0.052 nA/mmHg.
4-47
Measurement – pO2
Measurement The pO2 value for a sample is calculated from the following equation:
 pO 2Sol1 
pO 2 = nAmpSample ×  mmHg
pO2  nAmpSol1 
 pO2 
4-48
Corrections – pO2
Temperature The measured pO2 value can be corrected to reflect the patient’s body temperature
using the following relationship:
 
 
 1 
 0.0252× + 0.00564 ×(T −37)
   p O (37) 
3.88  
  0.243× 2
 +1  
   100   
 
pO 2 (T ) = pO 2 (37) × 10 mmHg [1]
where:
pO2(T) = Temperature-corrected pO2 value of sample.
pO2(37) = Measured pO2 value of the sample
4-49
The electrolyte sensors
Introduction This section describes the construction of the electrolyte sensors:

K+
Na+
Ca2+
Cl–
It also describes the measuring and calibration principles of these sensors.

Construction of the electrolyte sensors .................................................. 4-51
Measuring principle of the electrolyte sensors ...................................... 4-52
Calibration of the electrolyte sensors .................................................... 4-54
Measurement – electrolytes ................................................................... 4-55
4-50
Construction of the electrolyte sensors
Basic The K+, Na+, and Ca2+ sensors are of solid-state design. The membrane is of PVC
description with an ion-specific carrier.
1 22
3 44
5
The table below describes part of the electrolyte sensor.

1 Membrane An ion selective membrane sensitive to the subject
ion.
2 Electrolyte A solid-state material, which provides a constant
internal potential and an electrical connection
between the membrane and the electrode.
formed.
Location within The diagram below illustrates the location of the electrolyte sensors within the
sensor array cassette sensor array.
4-51
Measuring principle of the electrolyte sensors
Introduction All of the electrolyte sensors employ the same measuring principle. This section
describes the theory behind how these sensors measure the electrolyte
concentrations (cK+, cNa+, cCa2+, cCl–) in a sample.
Electrode chain The electrode chain (or electrical circuit) set up to measure the electrolytes is
illustrated in the following diagram:
Electrode chain The total potential across the electrode chain is a sum of the potential differences
potential at each of the elements in the chain, all but one of which is known and constant.
This is outlined in the following table.
Item Element Potential Symbol

1 Total potential. Measured by the Etot
voltmeter.
2 Reference electrode n/a
3 Electrolyte solution (Reference Known and constant when Eref
sensor) the Ag/AgCl is immersed
in the hydrogel solution.
4 Liquid junction between the Known and constant, ELJ
electrolyte solution in the independent of sample
reference sensor and the composition.
sample.
5 Sample n/a
6 Ion-sensitive membrane Unknown, dependent on ESample
junction separating the sample sample composition.
and the sensor.
7 Electrode/solid-state material. Known and constant. EE
(Electrolyte sensor)
4-52
Unknown The unknown potential difference across the ion-sensitive membrane is then the
potential difference between the measured total potential and the sum of the known
potentials:
E Sample = E tot −(E ref + E LJ + E E )
Ion-sensitive The potential difference across the ion-sensitive membranes arises as a

membranes consequence of a change in the charge balance at the membrane.
The membranes are made ion-sensitive by virtue of specific ion-carrying
molecules contained in the PVC. When the sample comes in contact with the
membrane, molecules pick up the specific electrolyte ions from the sample. This
creates a misbalance in charge. The number of positive and negative ions is no
longer exactly equal and the potential difference across the membrane changes.
Nernst equation The potential difference at the membrane in the electrolyte sensors can be
expressed by the Nernst equation:
RT
ESample = E0 + × ln aion
nF
where:
E0 = Standard electrode potential
R = Gas constant (8.3143 J/°K/mol)
T = Absolute temperature (°K)
n = Charge on the ion
F = Faraday constant (96487 C/mol)
aion = Activity of the specific ion
Activity and As shown in the Nernst equation above, measuring the potential of each of the
concentration electrode chains gives a reading of the activity of each of the ions in the sample.
The activity of each ion is automatically converted to a concentration value by the
analyzer.
The relationship between activity and concentration is explained in the section
General measuring principles at the beginning of this chapter.
4-53
Calibration of the electrolyte sensors
Introduction The electrolyte sensors are calibrated by determining the status and sensitivity
from 2-point calibrations. Performance of the sensor from calibration to
calibration is evaluated and any drift corrected during sample or quality control
analysis by measuring solution 1 during the sample analysis process.
2-point A series of 2-point calibrations is performed at preset intervals using solutions 1,

calibration 2, and 3 from the solution pack. The precise values for these solutions are recorded
in the smart chip on the solution pack.
The approximate electrolyte values for these solutions are shown in the following
table:
Electrolyte Solution 1 values Solution 2 values Solution 3 values
cK+ ∼3.4 mmol/L ∼8.8 mmol/L ∼2.5 mmol/L
cNa+ ∼149 mmol/L ∼104 mmol/L ∼160 mmol/L
cCa2+ ∼1.09 mmol/L ∼2.26 mmol/L ∼0.55 mmol/L
* cCl– ~110 mmol/L ~95 mmol/L ~130 mmol/L
* In addition, cCl– uses solution 4 during the calibration process, which
has an approximate chloride concentration in the ABL80 FLEX analyzer
of 16 mmol/L, and 74 mmol/L in the ABL80 FLEX CO-OX analyzer.
Sensitivity The sensitivity of the electrolyte sensors is obtained from the calibration line for
each sensor arising from a 2-point calibration, using solution 1 and solution 2.
The sensitivity values are calculated from the following equations:
E Cal2
Ca 2 +
− E Cal1
Ca 2 +
SCa 2 + =
 [Ca 2+ ]Cal2 
log10  2+ 
 [Ca ]Cal1 
E Cal2
K+
− E Cal1
K+
SK + =
 [K + ]Cal2 
log10  + 
 [K ]Cal1 
E Cal2
Na +
− E Cal1
Na +
S Na + =
 [Na + ]Cal2 
log10  + 
 [Na ]Cal1 
E Cal2
Cl −
− E Cal1
Cl −
SCl− =
 [Cl − ]Cal2 
log10  − 
 [Cl ] Cal1 
4-54
Measurement – electrolytes
Sensitivity limits The sensitivity limits of the electrolyte sensors are outlined in the following table:
Sensor Sensitivity limits

K+ 40 – 70.0 mV/Decade
Na+ 40 – 85.0 mV/Decade
2+
Ca 20 – 45.0 mV/Decade
–
Cl 30 – 65.0 mV/Decade
One decade is a 10 fold change in the activity level.
Measurement The electrolyte concentration in a sample is calculated from the following

equation:
cX sam = cX Cal1 *10

(E X sample − E X Cal1 ) mmol/L
Sx
4-55
Glucose and Lactate sensors
Introduction This section describes the construction of the glucose (Glu) and lactate (Lac)
sensors, how glucose and lactate are measured, and how the sensors are calibrated.

Construction of the Glu sensor .............................................................. 4-57
Measuring principle of the Glu sensor ................................................... 4-58
Calibration of the Glu sensor ................................................................. 4-60
Measurement – Glu ............................................................................... 4-61
Construction of the Lac sensor .............................................................. 4-62
Measuring principle of the Lac sensor ................................................... 4-63
Calibration of the Lac sensor ................................................................. 4-65
Measurement – Lac ............................................................................... 4-66
4-56
Construction of the Glu sensor
Basic The glucose sensor is a three-electrode sensor consisting of an internal silver/silver

description chloride reference electrode, a platinum auxiliary electrode, and a platinum anode.
The sensor is covered by a multi-layer membrane bound to the sensor board.
The membrane consists of three layers:
• Outer membrane – permeable to glucose
• Enzyme layer
• Inner membrane – permeable to H2O2
Diagram The following is a diagram of the glucose sensor.
Parts and The table below describes the parts of the glucose sensor.
description
1, 2 Outer membrane Biocompatible layer and membrane permeable to glucose
3 Enzyme layer Contains glucose oxidase
4 Inner membrane Cellulose acetate
5 Reference Ag/AgCl electrode
6 Anode Platinum electrode
7 Cathode Platinum electrode
8 Electrode base The structural platform on which the sensor is formed.
Location within The diagram below illustrates the location of the Glu sensor within the cassette
4-57
Measuring principle of the Glu sensor
Introduction This section describes the theory behind the measuring principle of the Glu sensor.
Description A constant polarization voltage of 650 mV is applied to the electrode chain. The
current through this chain is measured by an ampere meter.
Glucose molecules, in solution, are transported across the outer layer of a multi-
layer membrane. The enzyme glucose oxidase, immobilized between the outer and
inner layers, converts glucose according to the following reaction:
Glucose + H2O + O2 → Gluconic Acid + H2O2
The oxygen for this reaction is supplied by the outer membrane layer as well as by
the oxidation of H2O2 at the platinum anode.
The H2O2 produced by the enzyme reaction is transported across the inner
membrane to the platinum anode.
When a potential is applied to the electrode chain, the oxidation of H2O2 produces
an electrical current proportional to the amount of H2O2, which in turn is directly
related to the amount of glucose.
H2O2 → 2H+ + O2 + 2e–
To complete the electrical circuit, a reduction reaction (where electrons are
consumed) at the cathode converts Ag+ (from AgCl) to Ag.
Ag+ + e– → Ag
In maintaining a charge balance between the anode and cathode, two Ag+ ions
need to be reduced for one molecule of H2O2 to be oxidized. Also, some
combination of the following reduction processes occurs at the cathode:
H2O2 + 2e- → 2OH-
(This process consumes excess H2O2 not consumed in the reaction above.)
½O2 + 2H+ + 2e- → H2O
(This process consumes excess O2 not consumed in the reaction above.)
2H2O + 2e- → H2 + 2OH-
(This process can also occur at the cathode.)
Any of these three reactions at the cathode will serve to neutralize the protons
generated in the second reaction, so the total increase in acidity is caused by the
gluconic acid only.
Zero current The zero current is the current measured from the sensor when no glucose is
present in a solution. Because the rinse solution (Solution 1) contains no glucose, a
baseline representing the zero current, I0 as a function of time (I0 = f(t)), is
obtained from continuous measurements on the rinse solution during a time period
of up to 30 seconds.
4-58
This I0 baseline is obtained in the following manner:

• At the start of a new cassette installation, a period of constant polarization
lowers the baseline zero current value. Once the zero current value drops
below the threshold, the stability of the sensor is monitored and a stable zero
current endpoint value is determined.
• Directly prior to each calibration or sample analysis, with rinse solution in the
measuring chamber, the zero current and stability of the glucose sensor is also
determined.
• During the determination of the zero current value a moving average of six
concurrent measurements is calculated and continually updated, comparing
against the stability criterion.
• Once the stability criterion is met, the previous n (n=6) measurements on the
flush solution (before a calibration or sample measurement begins) are used to
obtain a baseline representing the stable value of I0.
The zero current is used to determine the sensitivity of the glucose sensor.
The zero current value is determined by averaging as follows:
6
∑I 0, n
I0 (mean) = n =1
nA
N
where:
I0(mean) = the zero current measurement in the flush solution.
I0,n = the n zero current measurements on the flush solution used to obtain I0
(mean)
4-59
Calibration of the Glu sensor
Sensitivity The sensitivity of the glucose sensor is calculated by measuring the current from
Solution 2 then subtracting the zero current as measured from solution 1. Solution
2 has a nominal glucose concentration of 15 mmol/L. The precise value is specific
to the individual lot of the solution pack and is contained in the solution pack
smart chip.
The current at the glucose sensor with Solution 2 in the measuring chamber is
measured at regular intervals after the chamber is filled with solution. The current,
when signal stability is reached, is used to determine the sensitivity of the glucose
sensor.
The signal stability is determined according to the following:
5
∑I n +1 − In
I∆ = n =0
nA
n
I ∆ = the average change of a string of data points
The signal stability criterion is:

I ∆ ≤ ±0.04 nA
The current due to the presence of glucose in Solution 2 (S2) is then calculated as
the difference between the current endpoint after stabilization criterion is met and
the zero current from Solution 1 (S1):
IS2(final) = IS2 – I0(mean)
where:
IS2(final) = sensor current due to the presence of glucose
The sensitivity of the sensor is calculated as follows:

I S 2 ( final )
SensGlu =
cGluS 2
where:
cGluS2 = actual concentration of glucose in Solution 2
Sensitivity limits The sensitivity limits of the glucose sensor are 0.20 – 1.40 nA/mmol/L
4-60
Measurement – Glu
Measurement The glucose concentration in a sample is calculated from the following equation:
I sample − I 0 (mean)
cGlusample = mmol/L
SensGlu
where:
Isample = current of the glucose sensor measured on the sample
SensGlu = relative sensitivity of the glucose sensor
4-61
Construction of the Lac sensor
Basic The lactate sensor is a three-electrode sensor consisting of an internal silver/silver

description chloride reference electrode, a platinum auxiliary electrode, and a platinum anode.
The sensor is covered by a multi-layer membrane bound to the sensor board.
The membrane consists of three layers:
• Outer membrane – permeable to lactate
• Enzyme layer
• Inner membrane – permeable to H2O2
Diagram The following is a diagram of the lactate sensor.
Parts and The table below describes the parts of the lactate sensor.
description
1, 2 Outer membrane Biocompatible layer and membrane permeable to
lactate
3 Enzyme layer Contains lactate oxidase
4 Inner membrane Cellulose acetate
5 Reference Ag/AgCl electrode
6 Anode Platinum electrode
7 Cathode Platinum electrode
8 Electrode base The structural platform on which the sensor is
formed.
Location within The diagram below illustrates the location of the Lac sensor within the cassette
4-62
Measuring principle of the Lac sensor
Introduction This section describes the theory behind the measuring principle of the Lac sensor.
Description
A constant polarization voltage of 650 mV versus Ag/AgCl is applied to the
electrode chain. The current through this chain is measured by an ampere meter.
Lactate molecules, in solution, are transported across the outer layer of a multi-
layer membrane. The enzyme lactate oxidase, immobilized between the outer and
inner layers in a cross-linked polymer matrix, converts lactate according to the
following reaction:
L-Lactate + H2O + O2 → Pyruvate + H2O2
The oxygen for this reaction is supplied by the outer membrane layer as well as by
the oxidation of H2O2 at the platinum anode.
The H2O2 produced by the enzyme reaction is transported across the inner
membrane to the platinum anode.
When a potential is applied to the electrode chain, the oxidation of H2O2 produces
an electrical current proportional to the amount of H2O2, which in turn is directly
related to the amount of lactate.
H2O2 → 2H+ + O2 + 2e–
To complete the electrical circuit, a reduction reaction (where electrons are
consumed) at the cathode converts Ag+ (from AgCl) to Ag.
Ag+ + e– → Ag
In maintaining a charge balance between the anode and cathode, two Ag+ ions
need to be reduced for one molecule of H2O2 to be oxidized. Also, some
combination of the following reduction processes occurs at the cathode:
H2O2 + 2e- → 2OH-
(This process consumes excess H2O2 not consumed in the reaction above.)
½O2 + 2H+ + 2e- → H2O
(This process consumes excess O2 not consumed in the reaction above.)
2H2O + 2e- → H2 + 2OH-
(This process can also occur at the cathode.)
Any of these three reactions at the cathode will serve to neutralize the protons
generated in the second reaction, so the total increase in acidity is caused by the
pyruvic acid only.
Zero current The zero current is the current measured from the sensor when no lactate is present
in a solution. Because the rinse solution (Solution 1) contains no lactate, a baseline
representing the zero current, I0 as a function of time (I0 = f(t)), is obtained from
continuous measurements on the rinse solution during a time period of up to 30
seconds.
4-63
Zero current, This I0 baseline is obtained in the following manner:

continued • At the start of a new cassette installation, a period of constant polarization
lowers the baseline zero current value. Once the zero current value drops
below the threshold, the stability of the sensor is monitored and a stable zero
current endpoint value is determined.
• Directly prior to each calibration or sample analysis, with rinse solution in the
measuring chamber, the zero current and stability of the lactate sensor is also
determined.
• During the determination of the zero current value a moving average of six
concurrent measurements is calculated and continually updated, comparing
against the stability criterion.
• Once the stability criterion is met, the previous n (n=6) measurements on the
flush solution (before a calibration or sample measurement begins) are used to
obtain a baseline representing the stable value of I0.
The zero current is used to determine the sensitivity of the lactate sensor.
The zero current value is determined by averaging as follows:
6
∑I 0, n
I0 (mean) = n =1
nA
N
where:
I0(mean) = the zero current measurement in the flush solution.
I0,n = the n zero current measurements on the flush solution used to obtain I0
(mean)
4-64
Calibration of the Lac sensor
Sensitivity The sensitivity of the lactate sensor is calculated by measuring the current from
Solution 2 then subtracting the zero current as measured from solution 1. Solution
2 has a nominal lactate concentration of 8.0 mmol/L. The precise value is specific
to the individual lot of the solution pack and is contained in the solution pack
smart chip.
The current at the lactate sensor with Solution 2 in the measuring chamber is
measured at regular intervals after the chamber is filled with solution. The current,
when signal stability is reached, is used to determine the sensitivity of the lactate
sensor.
The signal stability is determined according to the following:
5
∑I n +1 − In
I∆ = n =0
nA
n
I ∆ = the average change of a string of data points
The signal stability criterion is:

I ∆ ≤ ±0.023 nA
The current due to the presence of lactate in Solution 2 (S2) is then calculated as
the difference between the current endpoint after stabilization criterion is met and
the zero current from Solution 1 (S1):
IS2(final) = IS2 – I0(mean)
where:
IS2(final) = sensor current due to the presence of lactate
The sensitivity of the sensor is calculated as follows:

I S 2 ( final )
Sens Lac =
cLac S 2
where:
cLacS2 = actual concentration of lactate in Solution 2
Sensitivity limits The sensitivity limits of the lactate sensor are 0.25 – 1.59 nA/mmol/L
4-65
Measurement – Lac
Measurement The lactate concentration in a sample is calculated from the following equation:
I sample − I 0 (mean)
cLac sample = mmol/L
Sens Lac
where:
Isample = current of the lactate sensor measured on the sample
SensLac = relative sensitivity of the lactate sensor
4-66
Conductivity electrodes
Introduction This section describes the construction of the Hematocrit (Hct) and air-in-sample
detection electrodes (SC – solution conductivity), and their measurement and
calibration principles.

Construction of the conductivity electrode ............................................ 4-68
Measuring principle of the conductivity electrode ................................ 4-69
Calibration of the conductivity electrode............................................... 4-71
Measurement – Hct ............................................................................... 4-73
4-67
Construction of the conductivity electrode
Basic The conductivity sensor consists of a platinum electrode in direct contact with the
description sample.
Diagram The following is a diagram of the conductivity sensor.
22
3
Parts and The table below describes the parts of the conductivity sensor.
description
1 Electrode A platinum surface, which provides the electrical
contact to the sample.
formed.
Location within The following diagram below illustrates the location of the hematocrit and
sensor array solution conductivity (SC) electrodes within the cassette sensor array.
4-68
Measuring principle of the conductivity electrode
Introduction This section describes the theory behind the measuring principles of the
conductivity electrode.
Hct measuring Blood is a viscous fluid composed of plasma, cells, and proteins. More than 99%
principle of the cells are red blood cells (erythrocytes). Due to the presence of ions in the
plasma phase, blood is conductive. The cells present in blood are generally non-
conductive; therefore a measurement of the conductivity of blood is inversely
proportional to the number and size of erythrocytes present in the blood. This
measurement, therefore, can be related to the volume % of red cells or hematocrit
of a blood sample.
NOTE: The Hct measurement is only performed in the ABL80 FLEX analyzer, not
the ABL80 FLEX CO-OX analyzer.
Measurement The electrolyte, protein, and osmotic concentrations in a whole blood sample will
interference affect the hematocrit measurement.
Sodium is the primary electrolyte in plasma. The concentration of sodium has a
direct effect on the conductivity of the blood sample because it is a charged ion.
Measurement of the sodium concentration in each sample is performed and the
results used to correct the conductivity value for the effects of the sodium
concentration.
Plasma proteins are non-conducting structures that can occupy 1-7% of the plasma
volume. The protein concentration is assumed constant for all patients. This
assumption holds true in most cases. One important exception is a patient
undergoing cardiopulmonary bypass (or other circumstances where patients are
infused with plasma expanders or other blood diluents). The priming solution used
during cardiopulmonary bypass is a protein-free solution that significantly dilutes
the patient’s blood. This results in a measurement bias for Hct. A Hemodilution
Correlation Factor can be established and used to correct these diluted samples.
Hyperosmotic concentrations in whole blood will cause a decrease in the water
content within the red blood cell. This can result in a decreased hematocrit level as
the size of the red blood cell decreases.
4-69
Electrode chain The electrode chain (or electrical circuit) set up to measure Hct is illustrated in the
following diagram:
functions
1 RF Fixed resistor
2 Applied voltage Applies the necessary alternating current.
3 RS Variable impedance of the sample
4 Vout Is proportional to the conductivity measurement on
the unknown sample.
 RS 
Vout =   × Vin
 F
R + R S 
5 Electrode Platinum electrodes, which conduct the applied

voltage through the sample.
6 Sample Contacts the electrodes.
4-70
Calibration of the conductivity electrode
Introduction Conductivity of the calibration solutions and the sample is measured between the
Hematocrit 1 and Hematocrit 2 electrodes by means of the electrical chain
galvanically isolated from other circuits. The chain applies alternating voltage
between the electrodes at a frequency of 10 kHz.
The current measured through the sample is converted into the mV signal which is
then used for the calculation of Hct.
Calibration Performance of the Hct measuring circuit (conductivity meter) is described by the
sensitivity obtained during a calibration event.
The conductivity meter is calibrated using Solution 1 and Solution 2.
The following points describe how the conductivity is measured and a calibration
is performed.
• Solution 1, with a nominal conductivity of approximately 14.3 mS, fills the
measuring chamber. Once the stability criterion is satisfied, the system records
the resulting endpoint value. The saved value is the mean value in mV.
• Solution 2, with a nominal conductivity of approximately 11.3 mS, fills the
measuring chamber. Once the stability criterion is satisfied, the system records
the resulting endpoint value. The saved value is the mean value in mV.
• The conductivity of the empty measuring chamber is assumed to be 0 mS.
• Using these values, the sensitivities S1 and S2 are calculated, along with the
linearity.
• These calculated values are then used for measuring the hematocrit in blood and
quality control samples.
Sensitivity The following values are calculated:

• S1: The sensitivity between Solution 1 and Solution 2
• S2: The sensitivity between Solution 2 and the empty measuring chamber
• Linearity
mVS1 − mVS2
S1 = mV/mS
ConductivityS1 − ConductivityS2
mVS2 − mVempty
S2 = mV/mS
ConductivityS2 − Conductivity empty
S1
Linearity =
S2
where:
ConductivityS1 = nominal conductivity of Solution 1 (14.3 mS)
ConductivityS2 = nominal conductivity of Solution 2 (11.3 mS)
4-71
Conductivityempty = nominal conductivity of the empty measuring chamber (0 mS)
Sensitivity limits The calibration is considered successful if the following criteria are fulfilled:
S1
0.70 ≤ ≤ 1.25
S2
50 < S 2 < 300mV/mS
4-72
Measurement – Hct
Measurement Once the measuring chamber is filled with sample and the stability criteria are
met, the resulting endpoint is recorded and saved as the mVmeas.
The conductivity of the sample is then calculated as follows:
• If mVmeas > mVS2 then:
mVmeas − mVS1
Conductivity meas = ConductivityS1 +
S1
• If mVmeas < mVS2 then:
mVmeas − mVS2
Conductivity meas = ConductivityS2 +
S2
Hematocrit is then calculated from the Conductivitymeas value and the cNa+,
obtained from the measurement by the sodium sensor, as follows:
Hct = K 0 + K1 * lnConductivity meas + K 2 * (lnConductivity meas ) 2 +
Conductivity meas
+ K 3 * lncNa + + K 4 * (lncNa + ) 2 + K 5 * +
cNa +
2 3
 Conductivity meas   Conductivity meas 
+ K6 * +  + K7 * 
 cNa   cNa + 
where:
K0 = 4.30285
K1 = –0.05929
K2 = –0.01933
K3 = –1.47926
K4 = 0.16019
K5 = –8.95839
K6 = 56.32354
K7 = 244.21553
4-73
Optical System
Introduction This section describes the construction of the ABL80 FLEX CO-OX optical
system and the measurement and calibration principles.

Measuring principle ............................................................................... 4-75
Calibration.............................................................................................. 4-79
Correcting for interferences ................................................................... 4-80
Measurement and corrections ............................................................... 4-83
4-74
Measuring principle
Measured The optical system of the ABL80 FLEX CO-OX analyzer is designed to measure
parameters the following parameters:
Parameter Description
ctHb Concentration of total hemoglobin
sO2 Oxygen saturation
FO2Hb Fraction of oxyhemoglobin
FCOHb Fraction of carboxyhemoglobin
FHHb Fraction of deoxyhemoglobin
FMetHb Fraction of methemoglobin
Construction The optical system is based on a 138-wavelength spectrophotometer with a

measuring range of 467-672 nm. The spectrophotometer is connected via an
optical fiber to a combined hemolyzer and measuring chamber.
4-75
Measurement The measurement cycle consists of the following steps:

cycle
Step Description
1. The blood sample is transported to the cuvette positioned in the
hemolyzer unit. The temperature of the cuvette is regulated to 37 °C.
2. A back pressure is exerted on the sample. This one atmosphere over-
pressurization is maintained throughout the hemolyzation and
measurement to eliminate air bubbles in the sample and to enhance
the hemolyzation process.
3. The one µL sample in the cuvette is ultrasonically hemolyzed at a
frequency of about 30 kHz. This hemolyzation process ruptures the
walls of the red blood cells, evenly mixing the content of the red
blood cells with the plasma and producing an optically clear solution.
4. Light from a white LED is emitted to the cuvette and the light
transmitted through the cuvette is guided to the spectrophotometer via an
optical fiber.
5. The light passes through a slit that directs it towards an arrangement
of mirrors and a grating.
6. The grating separates the light into the colors of the rainbow and the
mirror focuses the light on a photodiode array.
7. The photodiode array has 256 diodes or pixels, one for each
wavelength, which convert the monochromatic light signals to
currents.
8. The currents and therefore the intensity of the light signals are
measured at each of the 256 diodes, which form the basis for the
absorption spectrum for a particular sample.
9. The spectrum is sent to the analyzer’s computer, where the
calculations of the oximetry parameter values are made.
The 256 channels are standardized into 138 selected wavelengths.
Lambert-Beer's 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
[2]:
Ayλ = ε yλ × cy × l
where:
Ayλ = absorbance of compound y at wavelength λ
ε yλ = extinction coefficient of compound y at wavelength λ (a constant,

characteristic of the compound)
cy = concentration of compound y in sample
l = length of the light path
4-76
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
intensity of light transmitted through the MetCal solution)
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
absorbance is an additive quantity.
For example, if a sample contains six compounds y1, y2, ….y6, the total absorbance
measured for that sample at wavelength λ1 is:
λ1
Atotal = Ayλ1 + Ayλ1 + Ayλ1 + Ayλ1 + Ayλ1 + Ayλ61
1 2 3 4 5
(
= l ε yλ1 cy1 + ε yλ1 cy2 + ε yλ1 cy3 + ε yλ1 cy4 + ε yλ1 cy5 + ε yλ1 cy6
1 2 3 4 5 6
)
If there are Y compounds and measurements are taken at n wavelengths, a general
expression can be written for Atotal at the wavelength λn:
Y
λn
Atotal
= ∑ ε yλ n
× cy × l
y =1
where:
λn = the individual wavelengths.
λn
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.
4-77
Spectrum The figure below shows three spectra: pure O2Hb, pure HHb in a low
example concentration, and the spectrum of 92 % oxygenated hemoglobin obtained by
adding the spectra of O2Hb and HHb. The additivity of absorption and the
continuity of the spectra can 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)
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:
138
cy = ∑ K yλn Atotal
λn
n =1
where:
K λyn = a constant specific to compound y at wavelength λn.
Matrix of The constants ( Kλyn ) are determined using Multivariate Data Analysis [2] where the
constants spectra of the calibration compounds are considered together with the reference
values of the calibration compounds. The essential interfering substances are also
taken into account.
4-78
Calibration
Calibration The optical system is calibrated at two points using the following:
materials
• The S7770 ctHb Calibration Solution with a known dye concentration to
determine the cuvette path length, l.
• A transparent solution from the solution pack in the analyzer to determine the
zero point, Io.
Zero point The zero point, Io, is the current (or intensity) measured by the photodiode array
on the transparent solution in the cuvette. During this “blank calibration” the ctHb
is calibrated to this zero point.
Io is measured automatically during system start up and during System Cycles.
Cuvette path The cuvette path length (i.e. the length of the light path) is determined from
length Lambert-Beer’s Law by measuring the absorbance of the colored dye present in
the tHb Calibration Solution (S7770), which has a known equivalent hemoglobin
concentration.
Beer’s Law: A = ε x Cdye x l

where:
A = absorbance
ε = extinction coefficient
Cdye = concentration of colored dye
l = length of light path
tHb calibration It is recommended that a tHb calibration is performed every three months.
frequency
4-79
Correcting for HbF interference
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 a correction is not performed.
It is thus important when measuring hemoglobin levels in premature neonates and
neonates aged 0-3 months, as well as adults suffering from thalassemia, to take into
account this difference [3].
The ABL80 FLEX CO-OX analyzer can automatically correct for HbF. See the
ABL80 FLEX operator’s manual, Chapter 9, Settings and Chapter 4, Sample
Measurements for information on enabling and using this correction feature.
NOTE: The ABL80 FLEX CO-OX analyzer performance is based on the
measurement of a normal human hemoglobin spectrum. Hemoglobin types other
than HbA and HbF interfere with hemoglobin measurements and are not
compensated for in the ABL80 FLEX CO-OX analyzer.
The diagram below shows the transition from fetal hemoglobin to adult
hemoglobin [4].
This graph is only a schematic and cannot be used to determine FHbF.
Deviation of If the difference between adult and fetal hemoglobin is not taken into account in
results measurements on samples containing HbF (e.g. from premature neonates and
neonates aged 0-3 months) then a deviation in the measurement will arise.
The deviation is most important for measurements of oxygen saturation (sO2 and
FO2Hb) and 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.
4-80
Correcting for The presence of HbF in a sample is detected from the difference spectrum between
HbF fetal and adult oxyhemoglobin. The amount of cO2HbF exceeding a certain level
indicates HbF interference. The analyzer automatically corrects for this
interference by subtracting the difference spectrum of fetal oxyhemoglobin from
the measured spectrum.
The ABL80 FLEX CO-OX analyzer can automatically correct for HbF thereby
eliminating any measurement interference. See the ABL80 FLEX operator’s
manual, Chapter 9, Settings and Chapter 4, Sample Measurements for information
on enabling and using this HbF correction feature.
4-81
Correcting for other interferences
Measurement The measured spectrum is compared to a model spectrum calculated from the
warnings determined concentrations. The difference between these two spectra is called the
residual spectrum. If this residual spectrum is too high, the oximetry results will be
flagged with a warning (error 581 - Oxi spectrum mismatch).
In addition, a warning will accompany oximetry results if any of the following
conditions exist:
• ctHb < −0.1 mmol/L or ctHb > 25 mmol/L
• FHb(deriv) < –2 % or FHb(deriv) > 102 %
where FHb(deriv) is defined as sO2, FO2Hb, FCOHb, FMetHb or FHHb
• SHb < −2 % or SHb > 10%
• Value of Turbidity < −0.5 % or > 5%
4-82
Measurement and corrections

Oximetry The oximetry parameters are calculated as follows:
parameter
calculations Parameter Equation
ctHb(meas) = cO2Hb + cCOHb + cHHb + cMetHb
cO2Hb
=
sO2 ceHb
ceHb = cHHb + cO2Hb (effective hemoglobin)
cO2Hb
=
FO2Hb ctHb
cCOHb
=
FCOHb ctHb
cHHb
=
FHHb ctHb
cMetHb
=
FMetHb ctHb
where:
cO2Hb = 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
Restrictions The following parameters will not be calculated:
Parameter Is not reported if…

sO2, FCOHb, FMetHb, ceHb = cHHb + cO2Hb < 0.75 mmol/L;
FHHb
ctHb < 1 mmol/L
The following conditions are the main requirements to exclude HbF suppression:
Parameter or Feature Requirement

ctHb > 5 mmol/L
FCOHb < 20 %
FMetHb < 10 %
4-83
Parameter or Feature Requirement

HbF correction – cO2HbF/ctHb should be more than 0.2
Enabled for levels >20%
HbF correction – No lower limit value for cO2HbF is required, i.e.
Enabled for all levels even adult blood samples will be corrected for HbF.
It may be of value when analyzing blood samples
from newborns who have received adult blood
transfusion. In these cases FHbF can be lower than
20 % and significant deviations of oximetry
parameters can occur.
HbF correction – No HbF corrections made.
Disabled
Corrections for The uncorrected hemoglobin concentration, ctHb(sample), measured on capillary

ctHb or syringe samples is corrected as follows:
Equation A:
ctHb(sample)
ctHb(sample,corr) =
Fcuv
where:
ctHb(sample,corr) = corrected ctHb

Fcuv = analyzer-dependent constant determined at tHb
calibrations and automatically stored by the analyzer
4-84
References
List of This section contains a list of the references for Chapter 4, Sensors.
References
1. CLSI document C12-A, Clinical and Laboratory Standards Institute, 940
West Valley Road, Suite 1400, Wayne, PA 19087.
2. Ewing GW. Instrumental methods of chemical analysis. 5th ed.
McGraw.Hill, 1985.
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, Beanen GH. Developmental changes in human hemoglobins.
Clin Dev Med 1971; 37: 175-203.
4-85
5. User-defined corrections
Introduction This chapter describes the basis of the user-defined corrections available for the
parameters measured in all versions of the ABL80 FLEX analyzer.

All parameters ........................................................................................5-4
5. User-defined corrections ABL80 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: The performance of all ABL80 FLEX analyzer versions are tested as described in
Chapter 6, Performance Characteristics, and each instrument is assumed to
operate accurately and optimally user-defined corrections should not generally be
applied. 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.
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.
Item Function
1 Displayed (corrected) parameter value (y axis)
2 Measured (uncorrected) parameter value (x axis)
3 Offset between the two correction lines
4 Correction line with a user correction
5 Correction line without a user correction (Slope = 1.0, Offset = 0)
5-2
ABL80 FLEX reference manual 5. User-defined corrections
Entering In all versions of the ABL80 FLEX analyzer the slope and the offset for each
user-defined parameter are configured via the Correlation setup screen. User corrected values
corrections are identified by displaying a list of those parameters with applied correlation
values on the results screen and printout.
NOTE: The user-defined corrections are not applied to measurements using the
Quality Control measurement mode.
For more information specific to the measurement interference of hematocrit on
hemodiluted samples, see Chapter 4, Sensors.
5-3
All parameters
Introduction This topic describes the process for establishing user-defined corrections for all
parameters. This process applies to all versions of the ABL80 FLEX analyzer.
Preparatory Prior to entering corrections for any parameter, the user must obtain the reference
action 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 ABL80 FLEX analyzer without user-
defined corrections, and on a single reference analyzer.
• A series of measurements that cover the entire measuring range should be
performed.
• The measurements should be made simultaneously on the ABL80 FLEX
analyzer and reference analyzers, and samples must be handled correctly.
Correct handling includes sufficient sample size to allow for adequate mixing in
a strict manner of each sample prior to each analyzer introduction. The samples
should be in a syringe no smaller than 2 mL.
• The slope and the offset must be calculated. The user may, for example, make a
linear correlation between the values measured on the ABL80 FLEX analyzer
and the reference analyzer, using the ABL80 FLEX analyzer as an independent
variable.
• The user must verify the corrections that are entered.
Correcting the The following corrections to the slope and offset are possible within the stated
slope and offset limits for arterial, capillary and venous samples:
Parameter Slope Offset

pH 0.80 – 1.20 ±0.05
pCO2 0.80 – 1.20 ±10 mmHg
pO2 0.80 – 1.20 ±20 mmHg
cK+ 0.80 – 1.20 ±1.0 mmol/L
±10 mmol/L
+
cNa 0.80 – 1.20
±1.00 mmol/L
2+
cCa 0.80 – 1.20
±10 mmol/L
–
cCl 0.80 – 1.20
cGlu 0.75 – 1.25 ±5.0 mmol/L
cLac 0.75 – 1.25 ±5.0 mmol/L
Hct 0.50 – 1.50 ±15%
5-4
ABL80 FLEX reference manual 5. User-defined corrections
The following corrections to the slope and offset are possible within the stated
limits for “other fluid” type of samples:

pH 0.10 – 10.0 ±1.00
pCO2 0.10 – 10.0 ±30 mmHg
pO2 0.10 – 10.0 ±50 mmHg
cK+ 0.10 – 10.0 ±10.0 mmol/L
cNa+ 0.10 – 10.0 ±100 mmol/L
cCa2+ 0.10 – 10.0 ±10.00 mmol/L
cCl– 0.10 – 10.0 ±100 mmol/L
cGlu 0.10 – 10.0 ±30 mmol/L
cLac 0.10 – 10.0 ±30 mmol/L
The following corrections to the slope and offset are possible within the stated
limits for “hemodilution” type sample corrections for hematocrit:

Hct 0.10 – 10.0 ±10.0
NOTE: The hemodilution correlation feature is not applicable to the ABL80 FLEX
CO-OX analyzer.
Correcting the The following corrections to the slope and offset are possible within the stated
slope and offset limits for arterial, capillary and venous samples unique to the ABL80 FLEX CO-
OX analyzer:
ABL80 FLEX
CO-OX
analyzer Parameter Slope Offset
ctHb 0.962–1.038 N/A
sO2 0.900–1.100 ±5.0%
FO2Hb N/A N/A
FCOHb N/A ±5.0%
FMetHb N/A ±5.1%
NOTE: The application of a correction to the sO2 will be reflected in the FO2Hb
and FHHb values.
5-5
Calculating The correction constants are determined according to:

correction
constants y=m×x+b
where:
x = Measured (uncorrected) parameter value (ABL80 FLEX
analyzer)
y = Displayed (corrected) parameter value (Reference analyzer)
m = Slope
b = Offset
5-6
6. Performance characteristics
Introduction This chapter describes the reference methods used to verify the performance of the
ABL80 FLEX and ABL80 FLEX CO-OX analyzers and how the correction
constants for each parameter are determined.
It describes the performance tests carried out to determine the accuracy and
precision of the analyzers under normal use.

Reference methods ........................................................................................... 6-3
Testing against a reference method........................................................6-4
Reference methods for the ABL80 FLEX analyzers .............................6-6
Performance tests ............................................................................................. 6-8
Definition of terms .................................................................................6-9
Performance test conditions – ABL80 FLEX analyzer .......................6-11
ABL80 FLEX performance test results ...............................................6-12
Performance test conditions – ABL80 FLEX CO-OX analyzer ..........6-20
ABL80 FLEX CO-OX performance test results ..................................6-21
Interference tests ..................................................................................6-30
6. Performance characteristics ABL80 FLEX reference manual
General information
Reference A reference method is an established procedure for measuring a particular

methods parameter, to which the ABL80 FLEX analyzer (all versions) can be compared.
The reference method comparisons lead to the determination of correction
constants for each parameter in the ABL80 FLEX analyzer.
Radiometer The reference methods Radiometer uses for each of the measured parameters in
reference the analyzer are outlined on the following pages.
methods
In cases where no recommended reference method exists, Radiometer has devised
its own method, the details of which are also found on the following pages.
Correcting for Measurements from all versions of the ABL80 FLEX analyzer are corrected for
systematic systematic deviations as explained in the section Testing against a reference
deviations method, bringing them in line with the reference method measurements.
Performance Performance tests are performed to determine the precision of all versions of the
tests ABL80 FLEX analyzer under normal use. Bias, day-to-day variation and
reproducibility are also determined.
The test conditions and definitions of the criteria used for the performance tests
are given in the section Performance Tests.
6-2
ABL80 FLEX reference manual 6. Performance characteristics
Reference methods
Introduction This section describes the reference methods used to verify the performance of all
ABL80 FLEX analyzer versions.

Testing against a reference method.......................................................... 6-4
Reference methods for the ABL80 FLEX analyzers ............................... 6-6
6-3
Testing against a reference method
Introduction Reference methods are established procedures used to measure particular

parameters, against which the ABL80 FLEX analyzer (all versions) can be
compared.
The general description of how Radiometer tests against reference methods is
given below.
Details of the reference methods used by Radiometer for each of the measured
parameters in the analyzer are outlined in the next section, Reference methods for
the ABL80 FLEX analyzers.
Testing against The following procedure is a general description of how the analyzers are tested
a reference against a reference method.
method
Step Action
1. A blood sample from a normal healthy adult is taken.
2. The blood sample is treated to give high and low level concentrations of
the parameter under study.
3. Simultaneous measurements of the specific parameter are taken on the
blood sample, using the reference method and the uncorrected
analyzer.
The two sets of measurements are plotted on the same axis, as shown
in the following example:
This example shows how measurements at 3-6 different levels of a
parameter may systematically differ using the uncorrected ABL80
FLEX analyzer and the reference method.
Item Function
1 Measured concentration (y axis)
2 True concentration (x axis)
3 Measurements taken by the Reference Method
4 Uncorrected measurements taken on ABL80 FLEX analyzer
6-4
Step Action
4. A comparison of the plots from the two sets of measurements is made.
The systematic deviations of the ABL80 FLEX measurements from
the reference method are corrected by the following equation:
cX Sample (corr.) =k n cX Sample +k m
where:
cXSample(corr) = Parameter value measured on analyzer
corrected for systematic deviations from
the reference method
kn and km = Correction constants determined by
comparison with the parameter value
measured using the reference method
cXSample = Parameter value measured on the
analyzer (uncorrected)
5. The correction constants in the above equation are determined,
bringing the results from the ABL80 FLEX measurements in line with
the reference method results.
Measuring For the test measurements against the reference method the syringe measurement
mode mode on the analyzer is used, with all the parameters enabled.
Test apparatus Five new ABL80 FLEX analyzers with all parameters available are used in the
and frequency tests against the reference methods.
Three to five levels of each parameter are tested over at least 3 days, with 5
repetitions on each day. This leads to 250 - 500 measurements per parameter.
Calibration The true compositions of the calibration solutions used for the ABL80 FLEX
solutions and analyzers and those used for the reference methods are determined, by measuring
gases them against solutions and gases traceable to Certified Reference Materials.
Verification To verify that the correction constants have been accurately determined, tests
against the reference method are repeated for each parameter.
6-5
Reference methods for the ABL80 FLEX analyzers
Overview of The following gives an overview of the reference methods used for each of the
reference parameters measured by the analyzer. Reference method comparison results are
methods documented in the following section titled Performance tests.
Parameters: pCO2 and pO2

Reference Method: These parameters are tested against tonometry. Blood gas
target values were calculated from certified gas mixtures traceable to NIST.
Parameters: pH, cK+, cNa+, cCa2+ and cCl-
Reference Method: These parameters are tested against the Radiometer
ABL725/735 analyzer whose performance specifications (including the
corrections) have been determined and validated according to the reference
methods outlined in the ABL700 Series Reference Manual.
Parameter: cGlu
Reference Method: This parameter was tested using whole blood samples against
two Radiometer ABL715 reference analyzers whose performance specifications
(including the corrections) have been determined and validated according to the
reference methods outlined in the ABL700 Series Reference Manual. In addition,
serum standard testing was performed to provide a comparison against a primary
reference method. The serum standard true values are determined by
spectrophotometry, using the hexokinase (HK) method recommended by CLSI [1].
A comparison against SRM 965a provides a third primary reference method. SRM
965a is a standard reference material that is certified against ID/GC/MS methods
recommended by CLSI [1].
Parameter: cLac
Reference Method: This parameter was tested using a serum standard as the
primary reference method. The serum standard true values are determined by
spectrophotometry, using a lactate dehydrogenase (LDH) method [2]. A secondary
method, using whole blood samples, was performed against two Radiometer
ABL835 reference analyzers whose performance specifications (including the
corrections) have been determined and validated according to the reference
methods outlined in the ABL800 Series Reference Manual.
Parameter: Hct
Reference Method: This parameter is tested against micro centrifugation using an
Adams MHCT II. This method is considered the standard for determination of
hematocrit (RBC’s) in a blood sample per CLSI standard H7-A3.
Parameter: ctHb
Reference Method: This parameter is tested using the HiCN method
recommended by CLSI [3] as well as tested against the Radiometer ABL735
analyzer whose performance specifications have been determined and validated
according to the reference methods outlined in the ABL700 Series Reference
Manual.
Parameters: sO2, FO2Hb, FCOHb, FMetHb, FHHb
Reference Method: All oximetry fractions are tested against the Radiometer
ABL735 analyzer whose performance specifications have been determined and
6-6
validated according to the reference methods outlined in the ABL700 Series

Reference Manual.
[1] Development of Definitive Methods for the National Reference System for the Clinical Laboratory. Approved
Guideline, NCCLS Publication NRSCL 1-A, 1991.
[2] Begmeyer. Methods of enzymatic analysis. 3rd ed., Verlag Chemie Deerfield Beach 1984; 6: 582-88.
[3] Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood. Approved
Standard – Third Edition. CLSI/NCCLS Publication H15-A3, 2000.
6-7
Performance tests
Introduction This section describes the performance tests that determine the precision of the
corrected ABL80 FLEX analyzers.
Definitions of the criteria used for the performance tests and the results of the tests
are also given in this section.

Definition of terms ................................................................................... 6-9
Performance test conditions – ABL80 FLEX analyzer ........................... 6-8
ABL80 FLEX performance test results ................................................. 6-12
Performance test conditions – ABL80 FLEX CO-OX analyzer .............. 6-8
ABL80 FLEX CO-OX performance test results .................................... 6-12
Interference tests .................................................................................... 6-30
6-8
Definition of terms
Introduction This section lists the terms used in the performance tests and their definitions.
Repeatability 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.
Imprecision The following table describes the parameters used to characterize precision during
parameters the performance tests on the ABL80 FLEX analyzers (all versions).
Parameter Description
S0 Repeatability
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.
SD Day-to-day variation
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.
SX Reproducibility
A measure of the standard deviation of results from
measurements of the same parameter under changed
conditions of measurement. The following contributing factors
are used:
• S0
• SD
• Instrument to instrument variations
• Sample variations under measurement
• Variation in calibration solution concentrations
• Variation in reference method measurements both on blood
and calibration solutions
6-9
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):
Bias = Xanalyzer - XREF.
Bias specifications are based on the following conditions:

• ambient temperature 25 °C
• relative humidity 50 %
• barometric pressure 760 mmHg
• 0.06 % CO2 in atmospheric air.
The measured value of the sample will deviate from the true value by a maximum
of:
Bias ± 2 × SX
6-10
Performance test conditions – ABL80 FLEX analyzer
Introduction The performance tests on the ABL80 FLEX analyzer was carried out under the
conditions outlined below.
Test equipment Five ABL80 FLEX analyzers with all parameters enabled.
Blood samples The blood samples used for testing are heparinized blood samples from healthy,
voluntary donors.
The blood is prepared to obtain the different concentration levels of each
measured parameter.
Test frequency Measurements of every parameter are taken on all analyzers with 5 measurements
for blood on every sample in each run, repeated for 3 days.
measurements
Measurements are performed by different operators.
The Radiometer default calibration schedule is used.
QC samples QUALICHECK4+ control solution is measured each day.
Experimental The following conditions are maintained throughout testing:

conditions
• Ambient temperature 22 - 25 oC
• Relative humidity 30 - 50 %
• Average CO2 content in atmospheric air
• Barometric pressure ~755 mmHg
6-11
ABL80 FLEX performance test results
Introduction This section lists the performance test results for each parameter measured by the
ABL80 FLEX analyzer.
The tests were conducted using syringe samples with a sample size of 70 µL.
For a definition of the terms used see the previous section Definition of Terms.
NOTE: The solutions used in the performance tests are those recommended by
Radiometer. Performances using other solutions cannot be verified.
The performance tests are performed under conditions where the analyzers are
not influenced by electromagnetic fields.
Whole blood
performance pH Bias S0 SD SX
test results for 7.0 0.005 0.004 0.003 0.022
pH/blood gases
7.4 0.003 0.004 0.003 0.011
7.7 -0.002 0.005 0.004 0.021
pCO2 (mmHg) Bias S0 SD SX

14 -0.18 0.39 0.38 1.23
42 0.04 0.39 0.35 1.41
49 0.64 0.40 0.21 1.49
70 0.57 0.65 0.61 3.37
126 -1.99 2.07 2.10 8.43
pO2 (mmHg) Bias S0 SD SX

14 -0.42 0.48 0.25 1.49
42 -0.33 0.59 0.54 1.12
84 -0.80 0.80 0.85 2.00
210 2.10 1.43 3.22 5.63
420 -5.30 4.89 4.38 15.18
NOTE: pO2 performance results are valid for analyzers with software version
1.23 or higher.
6-12
Whole blood cCa2+ (mmol/L) Bias S0 SD SX

performance
0.53 -0.04 0.01 0.00 0.02
test results for
electrolytes and 1.19 0.02 0.00 0.01 0.03
hematocrit
2.47 0.18 0.03 0.02 0.08
cK+ (mmol/L) Bias S0 SD SX

2.0 0.05 0.04 0.02 0.11
4.0 0.09 0.04 0.03 0.11
8.0 0.22 0.07 0.04 0.16
cNa+ (mmol/L) Bias S0 SD SX

120 -2.16 0.45 0.41 1.33
140 -0.18 0.40 0.38 1.17
180 -0.28 0.59 0.33 1.83
cCl– (mmol/L) Bias S0 SD SX

85 0.34 0.49 0.52 2.49
105 -0.48 0.47 0.60 1.91
140 0.10 0.88 0.87 2.85
Hct (vol%) Bias S0 SD SX

10 0.04 0.43 0.31 1.27
25 0.31 0.44 0.43 1.54
40 0.31 0.63 0.50 1.96
60 -0.21 0.62 0.69 2.33
75 -0.25 0.74 0.56 2.55
6-13
cGlu results Repeatability and reproducibility, S0 and Sx, are presented as the coefficient of
variation for cGlu in the following tables.
Whole blood cGlu Bias Repeatability Reproducibility N

performance (mmol/L) (CV0%) (CVx%)
test results for
5.3 -0.11 1.3% 6.0% 75
glucose against
an ABL715 15.3 0.10 1.0% 5.1% 75
31.6 0.81 1.0% 5.6% 75
42.3 -0.83 1.0% 8.0% 75
Primary cGlu Bias Repeatability Reproducibility N

reference (mmol/L) (CV0%) (CVx%)
method
2.07 0.27 2.3% 4.9% 75
performance
test results for 6.40 0.03 1.7% 3.6% 75
glucose
15.74 -0.20 1.3% 3.3% 75
24.86 -1.51 1.0% 2.7% 75
40.00 -0.83 0.8% 2.9% 75
NIST SRM 965a cGlu Bias Repeatability Reproducibility N

performance (mmol/L) (CV0%) (CVx%)
test results for
1.918 ±
glucose
0.020 0.12 3.0% 4.3% 15
4.357 ±
0.048 -0.07 1.5% 4.1% 15
6.777 ±
0.073 -0.48 1.4% 2.6% 15
16.240 ±
0.19 -0.7 1.5% 3.3% 15
NOTE: NIST SRM 965a was tested over one day. Four levels with different
glucose concentrations were tested. Each level was measured three times in
succession on five ABL80 FLEX analyzers.
6-14
cGlu linearity Linearity of the glucose sensor was evaluated using whole blood samples prepared
with five levels of glucose. The samples were tested on two ABL715 analyzers
and five ABL80 FLEX analyzers. The linear response of the ABL80 FLEX
glucose sensor was studied by performing measurements on the five blood glucose
levels over a three day period. Five measurements were performed on each level,
each day. A total of 450 measurements were performed.
The cGlu results from the ABL715 reference analyzer and the ABL80 FLEX
analyzer, as seen in the regression plot below, demonstrate a linear relationship.
50.0
40.0
cGlu ABL80 (mmol/L)
30.0
20.0
10.0
0.0
0.0 10.0 20.0 30.0 40.0 50.0
cGlu ABL715 (mmol/L)
cGlu linearity The linearity of the glucose sensor is dependent on the oxygen tension of the
versus pO2 sample. This dependence is due to the co-reaction of glucose and oxygen by the
enzyme glucose oxidase. Low pO2 levels can influence the linearity of the glucose
sensor. The following table outlines the glucose linearity as a function of the pO2 .
6-15
CAUTION: Low pO2 levels can influence the linearity of glucose measurements,
and can therefore result in falsely low glucose results. Please note that glucose
performance is not specified when the pO2 is less than 20 mmHg (2.7 kPa).
Impact of the pO2 level on Glucose linearity

If the pO2 level in a sample is: Then cGlu linearity specifications only
apply to cGlu values between:
<20 mmHg Linearity not specified. Interpret all

results with caution.
20-40 mmHg 0-10 mmol/L
≥90 mmHg 0-40 mmol/L
cGlu – total The total variation of the glucose sensor was tested by using whole blood samples
variation prepared with five levels of glucose. The samples were tested on two ABL715
reference analyzers and five ABL80 FLEX analyzers.
The percent bias from the reference analyzers is shown in the plot below. The
boundaries shown in this plot represent the total variation as determined by the
comparison of the ABL80 FLEX and ABL715 cGlu measurements. The total
variation is plotted on the y-axis.
Total variation (%) = ±2 * Reproducibility (as a percent of test level)
50%
40%
30%
20%
10%
%
0%
-10%
-20%
-30%
-40%
-50%
0 10 20 30 40 50 60 70
ABL715 (m m ol/L)
6-16
BASIC software The following tables list the performance test results for each parameter measured
configuration by the ABL80 FLEX analyzer with BASIC software configuration.
Whole blood
test results for 7.0 0.007 0.004 0.002 0.009
pH/blood gases -
BASIC software 7.4 0.000 0.004 0.002 0.009
configuration 7.7 -0.017 0.006 0.004 0.013

14 -0.52 0.39 0.30 0.84
42 0.68 0.39 0.24 0.92
49 0.91 0.50 0.18 1.10
70 1.68 0.81 0.40 1.62
126 4.36 1.37 1.95 4.04

14 -0.07 0.68 0.51 1.33
42 -0.58 0.56 0.35 1.29
84 0.06 1.09 0.50 2.52
210 1.49 2.26 1.37 5.11
420 -0.66 9.19 5.60 18.39
6-17

performance
0.50 0.02 0.01 0.01 0.02
test results for
electrolytes and 1.25 -0.01 0.01 0.00 0.02
hematocrit –
2.50 -0.09 0.01 0.03 0.06
BASIC software
configuration
2.0 0.09 0.06 0.04 0.11
4.0 0.00 0.03 0.03 0.10
8.0 0.09 0.06 0.03 0.14

120 1.15 0.48 0.29 1.71
140 0.29 0.40 0.25 1.58
180 1.05 0.56 0.72 2.19

91 -1.78 0.65 0.43 2.20
104 0.26 0.66 0.28 1.75
147 1.49 0.84 0.72 3.09
Hct (vol%) Bias S0 SD SX

10 0.92 0.20 0.39 0.68
25 0.40 0.34 0.35 0.71
40 0.25 0.43 0.35 1.01
60 -1.00 0.38 0.36 1.24
75 -0.45 0.44 0.61 1.48
6-18
cLac (mmol/L) Bias S0 SD SX

0.3 0.06 0.04 0.02 0.08
1 -0.03 0.05 0.04 0.13
5 0.14 0.07 0.10 0.20
10 0.30 0.10 0.22 0.63
15 0.43 0.22 0.52 1.37
20 -0.55 0.23 0.85 2.18
Note: Bias values based on serum standards. Imprecision based on whole blood
measurements.
CAUTION: Low pO2 levels can influence the linearity of lactate measurements,
and can therefore result in falsely low lactate results. Please note that lactate
Impact of the pO2 level on Lactate linearity

If the pO2 level in a sample is: Then cLac linearity specifications only
apply to cLac values between:

6-19
Performance test conditions – ABL80 FLEX CO-OX

analyzer
Introduction The performance tests on the ABL80 FLEX CO-OX analyzer was carried out
under the conditions outlined below.
Test equipment Five ABL80 FLEX CO-OX analyzers with all parameters enabled.
Blood samples The blood samples used for testing are heparinized blood samples from healthy,
voluntary donors.
The blood is prepared to obtain the different concentration levels of each
measured parameter.
Test frequency Measurements of every parameter are taken on all analyzers with 5 measurements
for blood on every sample in each run, repeated for 3 days.
measurements
Measurements are performed by different operators.
The Radiometer default calibration schedule is used.
QC samples QUALICHECK5+ control solution is measured each day.
Experimental The following conditions are maintained throughout testing:

conditions
• Ambient temperature 22 - 25 oC
• Relative humidity 30 - 50 %
• Average CO2 content in atmospheric air
• Barometric pressure ~755 mmHg
6-20
ABL80 FLEX CO-OX performance test results
ABL80 FLEX CO-OX analyzer.
Whole blood
test results for 7.0 0.008 0.004 0.002 0.017
pH/blood gases
7.4 0.003 0.004 0.003 0.010
7.7 0.006 0.005 0.004 0.018

14 0.38 0.49 0.59 1.26
42 1.31 0.53 0.50 1.50
49 1.14 0.61 0.46 1.51
70 -0.48 0.75 0.46 2.02
126 -6.37 1.06 1.11 3.81

14 -0.40 0.52 0.69 1.11
42 -0.65 0.59 0.85 1.42
84 -1.30 0.90 0.68 1.80
210 1.30 2.30 1.38 5.54
420 3.66 9.07 13.34 22.06
6-21

performance
0.50 -0.03 0.01 0.01 0.02
test results for
electrolytes and 1.25 -0.03 0.01 0.00 0.02
glucose
2.50 0.01 0.01 0.03 0.08

2.0 -0.01 0.04 0.01 0.11
4.0 -0.01 0.03 0.02 0.11
8.0 -0.05 0.03 0.04 0.13

120 0.57 0.31 0.16 1.26
140 -0.48 0.39 0.11 1.25
180 -0.04 0.48 0.36 1.64

91 -0.56 0.89 0.61 2.30
104 -0.06 0.61 0.34 2.19
147 0.31 0.55 0.30 2.30
cGlu (mmol/L) Bias S0 SD SX

1.0 -0.21 0.11 0.09 0.21
5.0 -0.09 0.11 0.17 0.30
15.0 0.40 0.31 0.19 0.77
25.0 0.49 0.34 0.56 1.74
40.0 -0.37 0.61 1.40 3.52
6-22
cGlu linearity Linearity of the glucose sensor was evaluated using whole blood samples prepared
with five levels of glucose. The samples were tested on two ABL735 analyzers
and five ABL80 FLEX CO-OX analyzers. The linear response of the ABL80
FLEX CO-OX glucose sensor was studied by performing measurements on the
five blood glucose levels over a three day period. Five measurements were
performed on each level, each day. A total of 224 measurements were performed.
The cGlu results from the ABL735 reference analyzer and the ABL80 FLEX CO-
OX analyzer, as seen in the regression plot below, demonstrate a linear
relationship.
50.0
40.0
cGlu ABL80 (mmol/L)
30.0
20.0
10.0
0.0
0.0 10.0 20.0 30.0 40.0 50.0
cGlu ABL735 (m m ol/L)
cGlu linearity The linearity of the glucose sensor is dependent on the oxygen tension of the
versus pO2 sample. This dependence is due to the co-reaction of glucose and oxygen by the
enzyme glucose oxidase. Low pO2 levels can influence the linearity of the glucose
sensor. The following table outlines the glucose linearity as a function of the pO2 .
CAUTION: Low pO2 levels can influence the linearity of glucose measurements,
and can therefore result in falsely low glucose results. Please note that glucose
Impact of the pO2 level on Glucose linearity

If the pO2 level in a sample is: Then cGlu linearity specifications only
apply to cGlu values between:

6-23
cGlu – total The total variation of the glucose sensor was tested by using whole blood samples
variation prepared with five levels of glucose. The samples were tested on two ABL735
reference analyzers and five ABL80 FLEX CO-OX analyzers.
The percent bias from the reference analyzers is shown in the plot below. The
boundaries shown in this plot represent the total variation as determined by the
comparison of the ABL80 FLEX CO-OX and ABL735 cGlu measurements. The
total variation is plotted on the y-axis.
Total variation (%) = ±2 * Reproducibility (as a percent of test level)
50%
40%
30%
20%
Total variation (%)
10%
0%
-10%
-20%
-30%
-40%
-50%
0 10 20 30 40 50
cGlu ABL735 (m m ol/L)
6-24
NOTE: Samples used to determine performance results for ctHb, sO2, FO2Hb
and FHHb contained only normal dyshemoglobin levels.
NOTE: Samples used to determine performance results for FCOHb and FMetHb
were oxygenated.
Whole blood ctHb (g/dL) sO2 (%) Bias S0 SD SX

performance
7.0 100.0 -0.03 0.07 0.05 0.17
test results for
oximetry, CO- 15.0 100.0 -0.09 0.15 0.11 0.29
OX software
25.0 100.0 -0.42 0.37 0.12 0.51
configuration
15.0 0.0 0.16 0.12 0.07 0.26
sO2 (%) ctHb Bias S0 SD SX

(g/dL)
100.0 7.0 0.10 0.05 0.09 0.47
100.0 15.0 0.02 0.04 0.03 0.26
100.0 25.0 -0.11 0.31 0.12 0.53
0.0 15.0 -0.04 0.04 0.03 0.29
FO2Hb (%) ctHb Bias S0 SD SX

(g/dL)
100.0 7.0 -0.35 0.10 0.36 0.48
100.0 15.0 -0.25 0.06 0.21 0.35
100.0 25.0 0.01 0.07 0.15 0.50
0.0 15.0 0.07 0.04 0.03 0.21
FCOHb (%) ctHb Bias S0 SD SX

(g/dL)
20.0 15.0 -0.14 0.05 0.05 0.54
0.0 15.0 0.02 0.04 0.04 0.47
FMetHb (%) ctHb Bias S0 SD SX

(g/dL)
20.0 15.0 -0.25 0.18 0.13 0.43
0.0 15.0 0.23 0.19 0.18 0.48
6-25
FHHb (%) ctHb Bias S0 SD SX

(g/dL)
0.0 15.0 -0.24 0.07 0.06 0.57
100.0 15.0 -0.42 0.11 0.12 0.29
Limit of The limit of quantitation (LOQ) is defined as the lowest actual amount of analyte
quantitation that can be reliably detected and at which the total error meets the laboratory’s
requirements for accuracy.
The optical system in the oximetry module is a spectrophotometer with a linear
output as a function of specific analyte concentrations. For some measured
quantities, the raw instrument output at low levels can result in negative
concentrations and at high levels can result in concentrations greater than 100%.
Because these values are not physiologically possible, the ABL80 FLEX CO-OX
analyzer includes a software feature to suppress values less than zero and above
100%.
See the operator’s manual, Chapter 9, Settings / Reports – Input fields for
information on enabling this feature.
Test conditions An LOQ study was performed on five ABL80 FLEX CO-OX analyzers using
methods described in CLSI Doc. EP17. Samples were whole human blood
prepared at specific test levels. A total of 75 samples per level were tested. Each
sample was split between two ABL735 reference analyzers. The mean bias from
reference and the pooled precision estimate (reproducibility, Sx) was calculated for
each level. These values were combined to provide an estimate of total error (TE)
at each level, using the following equation:
TE = |Bias| + 2 × Sx
The 95% confidence interval indicates the range in which a sample with a true
value equal to the LOQ will be measured.
6-26
LOQ reference The following table provides the limits of quantitation for the oximetry parameters
table when value suppression (< 0.0% and >100.0%) is not enabled.
Limits of Quantitation
95% Confidence
Reproducibility
Interval
Parameter Unit Level LOQ Bias Sx TE Lower Upper
ctHb g/dL 7 x 0.09 0.17 0.43 6.75 7.43

sO2 % 0 x 0.07 0.18 0.43 -0.29 0.43
100 0.38 0.42 1.22 99.54 101.22
FO2Hb % 0 x 0.07 0.21 0.49 -0.35 0.49
100 -0.25 0.35 0.45 99.05 100.45
FCOHb % 0 x 0.45 0.33 1.11 -0.21 1.11
FMetHb % 0 x -0.23 0.48 0.73 -1.19 0.73
FHHb % 0 x -0.24 0.57 0.90 -1.38 0.90
100 -0.42 0.29 0.16 99.00 100.16
= not physiologically possible
LOQ reference The following table provides the limits of quantitation for the oximetry parameters
table – when value suppression (< 0.0% and >100.0%) is enabled.
suppression
Limits of Quantitation - value suppression enabled
enabled
Reproducibility 95% Confidence Interval
Sx TE Lower Upper
Parameter Unit Level LOQ Bias
ctHb g/dL 7 x 0.09 0.17 0.43 6.75 7.43
sO2 % 0 x 0.07 0.18 0.43 0 0.43
100 0.38 0.42 1.22 99.54 100
FO2Hb % 0 x 0.07 0.21 0.49 0 0.49
100 -0.25 0.35 0.45 99.05 100
FCOHb % 0 x 0.45 0.33 1.11 0 1.11
FMetHb % 0 x -0.23 0.48 0.73 0 0.73
FHHb % 0 x -0.24 0.57 0.90 0 0.90
100 -0.42 0.29 0.16 99.00 100
6-27
ABL80 FLEX CO-OX analyzer with OSM software configuration.
NOTE: The performance tests are performed under conditions where the analyzers are
not influenced by electromagnetic fields
NOTE: Samples used to determine performance results for FCOHb and FMetHb were
oxygenated.
NOTE: Samples used used to determine performance results for ctHb, sO2, FO2Hb and
FHHb contained only normal dyshemoglobin levels
Whole blood ctHb (g/dL) sO2 (%) Bias S0 SD SX

performance
7.0 100.0 0.06 0.06 0.04 0.16
test results for
oximetry, OSM 15.0 100.0 -0.12 0.11 0.05 0.30
software
25.0 100.0 -0.22 0.18 0.22 0.44
configuration
15.0 0.0 0.10 0.10 0.06 0.27
sO2 (%) ctHb Bias S0 SD SX

(g/dL)
100.0 7.0 -0.07 0.07 0.30 0.41
100.0 15.0 -0.10 0.04 0.15 0.25
100.0 25.0 -0.01 0.04 0.08 0.27
0.0 15.0 -0.03 0.05 0.12 0.22
FO2Hb (%) ctHb Bias S0 SD SX

(g/dL)
100.0 7.0 -0.85 0.09 0.11 0.46
100.0 15.0 -0.80 0.05 0.07 0.45
100.0 25.0 -0.48 0.06 0.07 0.82
0.0 15.0 -0.03 0.04 0.11 0.25
6-28
FCOHb (%) ctHb Bias S0 SD SX

(g/dL)
20.0 15.0 -0.12 0.06 0.28 0.41
0.0 15.0 -0.11 0.06 0.24 0.35
FMetHb (%) ctHb Bias S0 SD SX

(g/dL)
20.0 15.0 0.30 0.07 0.36 0.59
0.0 15.0 0.83 0.06 0.40 0.64
FHHb (%) ctHb Bias S0 SD SX

(g/dL)
0.0 15.0 0.09 0.05 0.14 0.27
100.0 15.0 -0.66 0.06 0.23 0.53
6-29
Interference tests
Introduction This section gives an outline of the interfering substances and the results of
interference tests on all versions of the ABL80 FLEX analyzer.
Interference A test of analytical specificity was performed using multiple potential interfering
testing protocol substances found in the clinical setting per CLSI document EP7-P. Either aqueous
or whole blood samples were prepared with known parameter concentrations at
normal levels. The samples were split and spiked with either the interferent (test)
or an equal amount of diluent without interferent (control). Three replicates each
of control (C) and test (T) samples were run for each substance as follows: C, C1,
T1, C, C2, T2, C, C3, T3. The difference between the mean of C1, C2, C3 and T1,
T2, T3 was calculated as the amount of interference.
6-30
pH and blood Intralipid (20 % solution) in a concentration greater than 4 % (the final Intralipid
gases content being 0.8 %) will give interference on pH measurements.
Electrolytes The following interference results are found on the electrolyte electrodes:
Interference on…
+
Substance Test Conc. cK cNa+ cCa2+ cCl–
(mmol/L ) ( mmol/L) (mmol/L ) (mmol/L)
Limit for 0.1 1 0.01 1

clinical
relevance
Li+ 4 mmol/L 0.0 0 0.04
K+ 12 mmol/L 0 0.01
Na+ 175 mmol/L 0.0 0.10
NH4+ 1 mmol/L 0.1 0
2+
Ca 5 mmol/L 3
2+
Mg 5 mmol/L 0.1 3 0.17
−
Br 10 mmol/L 27
–
F 1 mmol/L 0
-
F 50 mmol/L
–
I 3.0 mmol/L 26
–
ClO4 1.5 mmol/L 18
HCO3– 40 mmol/L 4
Lactic acid 10 mmol/L -3
Acetyl-salicylic 3 mmol/L 3
acid
Ascorbic acid 1 mmol/L -1
Ascorbic acid 2 mmol/L
Acetaminophen 2 mmol/L
pH ≤ 7.2 7.2 0.0 0 0.01 -1
pH ≥ 7.6 7.6 0.0 0 -0.01 2
Benzalkonium- 10 mg/dL 0.6 20 0.39 -1
heparin
6-31
Glucose and The following interference results are found on the glucose and lactate sensors:
lactate
Substance Test Interference on Interference on
Concentration cGlu cLac
(mmol/L unless (5.0 mmol/L level) (1.0 mmol/L
stated otherwise) level)
Limit for
clinical <|0.35| <|0.30|
relevance
Acetylsalicylic 1.68 <|0.1|
<|0.1|
acid
Chlorpromazine 0.05 <|0.1| <|0.1|
Dopamine 0.85 Up to 2.28* Up to 0.72*
Ethanol 76 Up to 0.22* <|0.1|
Salicylic acid 6.51 <|0.1| <|0.1|
Acetaminophen
(also known as 0.4 Up to 0.33* <|0.1|
paracetamol)
Creatinine 0.39 <|0.1| <|0.1|
Urea 19 <|0.1| <|0.1|
D-Glucose 67 N/A <|0.1|
Lactic acid 6.66 <|0.1| N/A
Heparin 8000 IU/dL <|0.1| <|0.1|
Thiocyanate 7.11 Interference Interference
Fluoride 0.78 <|0.1| <|0.1|
Maltose 5** <|0.1|
Galactose 3.3** Up to 0.41*
Glucosamine 2** Up to 0.50*
Xylose 1** Up to 0.21*
Icodextrin 5 g/L** <|0.1|
Icodextrin 10 g/L** <|0.1|
Icodextrin 20 g/L** Up to 0.20*
* Based on the upper limit of the 95% confidence interval
** Interference values determined at cGlu = 0.0 mmol/L
6-32
Substance Test Interference on Interference on

Concentration cGlu cLac
(mmol/L unless (5.0 mmol/L level) (1.0 mmol/L
stated otherwise) level)
2-PAM Iodide 12 µg/mL <|0.1|
2-PAM Iodide 125 µg/mL Up to 0.30*
Ascorbic acid 2 Up to 0.26* <|0.1|
Uric acid 1.5 <|0.1| <|0.1|
Ibuprofen 0.4 <|0.1|
* Based on the upper limit of the 95% confidence interval
6-33
Oximetry Interference results for all reported oximetry parameters are included in the table
below.
Substance Level ctHb sO2 FO2Hb FCOHb FMetHb FHHb

g/dL % % % % %
Limit for >|0.5| >|1.0| >|1.0| >|1.0| >|1.0| >|1.0|
clinical
relevance
pH 6.85 <|0.5| -1.1 -2.5 <|1.0| 1.4 1.1
7.15 <|0.5| <|1.0| -1.0 <|1.0| <|1.0| <|1.0|
8.00 <|0.5| <|1.0| -1.1 <|1.0| 1.3 <|1.0|
Fluorescein 250 mg/L 1.3 -3.2 -9.5 -4.1 10.7 2.9
Beta- 3.7 µmol/L <|0.5| <|1.0| <|1.0| <|1.0| <|1.0| <|1.0|

carotene
Patent 10 mg/L <|0.5| <|1.0| 1.5 <|1.0| <|1.0| <|1.0|
Blue V
Methylene 10 mg/L <|0.5| <|1.0| 3.7 <|1.0| -3.2 <|1.0|
Blue 30 mg/L -1.6 2.7 13.7 <|1.0| -11.2 -2.8
60 mg/L -3.0 4.2 27.8 -1.2 -21.5 -5.1
Cardio 7 mg/L <|0.5| <|1.0| <|1.0| <|1.0| <|1.0| <|1.0|
Green 30 mg/L <|0.5| <|1.0| 1.6 <|1.0| -1.2 <|1.0|
Evans Blue 5 mg/L <|0.5| <|1.0| <|1.0| <|1.0| <|1.0| <|1.0|
Intralipid 2% <|0.5| <|1.0| <|1.0| <|1.0| <|1.0| <|1.0|

5% <|0.5| <|1.0| -1.4 <|1.0| <|1.0| <|1.0|
HiCN 30% 1.74 -13.9 -40.1 6.6 23.8 9.7
SHb 20% -2.1 <|1.0| <|1.0| <|1.0| <|1.0| <|1.0|

50% -4.5 1.7 -5.7 <|1.0| 7.3 -1.6
Bilirubin 342 µmol/L <|0.5| <|1.0| <|1.0| <|1.0| <|1.0| <|1.0|
(unconju-
gated)
Bilirubin 342 µmol/L <|0.5| <|1.0| <|1.0| <|1.0| <|1.0| <|1.0|
(conju-
gated)
6-34
Fetal Interference results for samples containing fetal hemoglobin (HbF) are listed in the
hemoglobin table below
NOTE: There is no interference for HbF when the fetal hemoglobin correction
feature is applied.
Substance Level ctHb sO2 FO2Hb FCOHb FMetHb FHHb
g/dL % % % % %
Limit for >|0.5| >|1.0| >|1.0| >|1.0| >|1.0| >|1.0|
clinical
relevance
FHbF* 80% <|0.5| 4.4 1.4 2.1 <|1.0| -4.1
20% <|0.5| 1.1 <|1.0| <|1.0| <|1.0| -1.0
Hydroxo- 0.2 g/L <|0.5| <|1.0| -2.33 <|1.0| 1.83 <|1.0|

cobalamin <|1.0| <|1.0| <|1.0|
0.4 g/L 0.52 -4.00 3.37
(synthetic
0.8 g/L 1.07 <|1.0| -7.40 1.02 5.87 <|1.0|
vitamin
B12) 2 g/L 2.37 <|1.0| -15.85 2.48 12.73 <|1.0|
Cyano- 0.2 g/L <|0.5| <|1.0| -2.23 <|1.0| 1.35 <|1.0|

cobalamin <|1.0|
0.4 g/L 0.69 -1.27 -5.23 3.18 1.17
(synthetic
0.8 g/L 1.15 -2.02 -8.68 1.53 5.33 1.82
vitamin
B12) 2 g/L 2.29 -4.12 -16.23 2.85 9.87 3.52
With ctHb value of 15 g/dL
6-35
7. Parameters
Introduction This chapter defines all the measured, input, and derived parameters available with
the ABL80 FLEX analyzer (all versions). It gives the symbols, units and suggested
reference ranges for each of the parameters, together with the equations used in
deriving the parameters.
Definitions and symbols ....................................................................................7-2
Acid-base parameters .............................................................................7-5
Oxygen parameters.................................................................................7-7
Oximetry parameters ............................................................................7-10
Electrolyte/metabolite parameters ........................................................7-11
Units and ranges ..............................................................................................7-12
Introduction ..........................................................................................7-13
Measured parameters ...........................................................................7-14
Input Parameters ..................................................................................7-16
Derived parameters ..............................................................................7-17
Equations .........................................................................................................7-21
General information .............................................................................7-22
List of equations ...................................................................................7-23
Oxyhemoglobin dissociation curve (ODC) ..........................................7-34
Conversion of units ..............................................................................7-39
Default values ......................................................................................7-41
References ............................................................................................7-42
7. Parameters ABL80 FLEX reference manual
Definitions and symbols
Introduction This section divides all the ABL80 FLEX parameters into groups according to
type, giving the symbol and a definition of each parameter.
General information ............................................................................ 7-3
Acid-base parameters .......................................................................... 7-5
Oxygen parameters.............................................................................. 7-7
Electrolyte/metabolite parameters ....................................................... 7-11
7-2
ABL80 FLEX reference manual 7. Parameters
General information
pH and blood Traditional pH and blood gas analysis establishes the acid-base status of blood by
gas analysis measuring pH, pCO2 and occasionally ctHb, and gives partial information
concerning the oxygen status of blood by measuring pO2.
Electrolyte Electrolyte analysis establishes the patient's electrolyte status by measuring plasma
+ +
analysis concentrations of K , Na , Ca2+ and Cl– ions by means of ion-selective electrodes.
Metabolite Metabolite analysis consists of the measurement of the patient's glucose or lactate
analysis concentration by means of an enzyme electrode.
The Deep The Deep Picture developed by Radiometer [1], expands traditional pH and blood
Picture™ gas analysis by evaluating the capability of arterial blood to carry sufficient oxygen
to tissues and to release it. It simplifies interpretation by dividing the process into
steps:
Part Function
Oxygen uptake Oxygen uptake in the lungs indicates whether the
pulmonary gas 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)), fraction of O2 in dry inspired air (FO2(I)),
and the difference in alveolar air and arterial blood oxygen
tension (pO2(A-a)).
Oxygen transport Oxygen transport reveals whether arterial blood contains
sufficient oxygen.
The oxygen concentration of arterial blood (ctO2(a)) also
termed 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)).
Oxygen release Oxygen release describes the ability of arterial blood to
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.
7-3
Definitions The definition for each parameter is given in the tables on the following pages.
Symbols The symbols for the parameters are based on the principles described by Wandrup
[2].
When temperature symbols are not stated, the temperature is assumed to be 37 °C.
Each symbol consists of three parts, described using the following example and
table:
EXAMPLE:
pO2(a) - partial pressure (tension) of oxygen in arterial blood
Part Description Examples

p Quantity - A symbol in italics describing the p for pressure
quantity
c for concentration
F for fraction
V for volume
O2 Component - An abbreviation of the O2 for oxygen
component name
CO2 for carbon dioxide
(a) System - Specification of the system B for blood
P for plasma
a for arterial blood
v– for mixed venous blood

A for alveolar air
T for patient temperature
7-4
Acid-base parameters
Introduction Below is a list of symbols and definitions for all the acid-base parameters
measured, derived or used by the analyzer.
In the column headed Type the following symbols are used:
• ms for measured parameters
• dv for derived parameters
• in for input parameters
The column headed Eq. gives the number of the equation used to derive the
parameter. These equations are found in the section Equations in this chapter.
Table of acid- The following table lists all the acid-base parameters:
base parameters
Symbol Definition Type Eq.
Baro Ambient barometric pressure (p(amb)). in
pH Indicates the acidity or alkalinity of the sample. ms
pH(T) pH of blood at patient temperature. dv 1
pCO2 Partial pressure (or tension) of carbon dioxide in ms
blood.
High and low pCO2 values of arterial blood
indicate blood hypercapnia and hypocapnia
respectively.
pCO2(T) Partial pressure (or tension) of carbon dioxide at dv 2
patient temperature.
cHCO3–(P) Concentration of hydrogen carbonate in plasma dv 3
(also termed actual bicarbonate).
cBase(B) Actual Base Excess, the concentration of titrable dv 4
base when the blood is titrated with a strong base or
or ABE
acid to a plasma pH of 7.40, at pCO2 of 40 mmHg
(5.33 kPa) and 37 (C, at the actual oxygen
saturation [4,5].
Positive values (base excess) indicate a relative
deficit of noncarbonic acids; negative values (base
deficit) indicate a relative excess of noncarbonic
acids.
7-5

cBase(B,ox) cBase(B) of fully oxygenated blood. dv 5
cBase(Ecf) Standard Base Excess, an in vivo expression of dv 6
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) cBase(Ecf) of fully oxygenated blood. dv 7
cHCO3– (P,st) Standard Bicarbonate, the concentration of dv 8
hydrogen carbonate in the plasma from blood
which is equilibrated with a gas mixture with
pCO2 = 40 mmHg (5.33 kPa) and
pO2 ≥ 100 mmHg (13.33 kPa) at 37 °C [4,5].
ctCO2(B) Concentration of total carbon dioxide in whole dv 9
blood (also termed CO2 content).
Calculated based on the total CO2 concentrations
in the two phases: plasma and erythrocyte fluid
[5].
ctCO2(P) Concentration of total carbon dioxide in plasma dv 10
7-6
Oxygen parameters
Introduction Below is a list of symbols and definitions for all the oxygen parameters measured,
derived or used by the analyzer.
• * ABL80 FLEX CO-OX analyzer only
Table of oxygen The following table lists all the oxygen parameters:
parameters
pO2 Partial pressure (or tension) of oxygen in blood. ms
High and low pO2 values of arterial blood indicate
blood hyperoxia and hypoxia respectively.
pO2(T) Partial pressure (or tension) of oxygen at patient dv 11,
temperature. 12
pO2(A) Partial pressure (or tension) of oxygen in alveolar air. dv 13
pO2(A-a) Difference in the partial pressure (or tension) of dv 14
oxygen in alveolar air and arterial blood.
Indicates the efficacy of the oxygenation process in
the lungs.
pO2(a/A) Ratio of the partial pressure (or tension) of oxygen in dv 15
arterial blood and alveolar air.
Indicates the efficacy of the oxygenation process in
the lungs.
ctO2 Total oxygen concentration of blood. dv 16,
17,
Also termed O2 content.
18
7-7

FO2(I) Fraction of oxygen in dry inspired air in
Liter Flow Rate of oxygen flow delivered to the patient in
RI Respiratory Index; ratio between the oxygen tension dv 19
difference of alveolar air and arterial blood and the
oxygen tension of arterial blood.
sO2 Oxygen saturation dv 20,
21
(Available as a derived parameter in the ABL80
FLEX analyzer only)
sO2(m) Oxygen saturation as measured by a CO-oximeter in
ctHb(m) Concentration of hemoglobin in the blood as in
measured by a CO-oximeter
ctHb Concentration of hemoglobin in the blood dv 22
(Available as a derived parameter in the ABL80
FLEX analyzer only)
ctHb(d) Default value for the concentration of hemoglobin in in
the blood
pO2(a)/ Oxygen tension ratio of arterial blood and the fraction dv* 28
of oxygen in dry inspired air
FO2(I)
p50 Partial pressure (or tension) of oxygen at half dv* 29
saturation (50%) in blood.
High and low values indicate decreased and increased
affinity of oxygen to hemoglobin, respectively.
p50(st) Partial pressure (or tension) of oxygen at half dv* 30
saturation (50%) in blood at standard conditions:
Temperature = 37 °C
pH = 7.40
pCO2 = 5.33 kPa
FCOHb, FMetHb and FHbF set to 0
p50(st) may however vary due to variations in 2,3
DPG concentration or to the presence of abnormal
hemoglobins.
7-8

pO2(x) Oxygen extraction tension of arterial blood. dv* 31
Reflects the integrated effects of changes in the
arterial pO2(a), ctO2 and p50 on the ability of arterial
blood to release O2 to the tissues [8]
BO2 Hemoglobin oxygen capacity; the maximum dv* 32
concentration of oxygen bound to hemoglobin in
blood saturated, so that all deoxyhemoglobin is
converted to oxyhemoglobin
· Oxygen delivery; the total amount of oxygen dv* 33
D O2
delivered to the whole organism per unit of time.
· Cardiac output; volume of blood delivered from the dv*/in 34
Qt
left ventricle into the aorta per unit of time.
Also termed CO or C.O.
· Oxygen consumption; total amount of oxygen utilized dv*/in 35
VO2
by the whole organism per unit of time.
FShunt Relative physiological shunt or concentration-based dv* 36
shunt [5,8,9].
• Calculated from the pulmonary shunt equation:

Q 1
s
=

Q ctO 2 (a − v)
t 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)
Qx Cardiac oxygen compensation factor of arterial blood dv* 37
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].
V(B) Volume of blood, calculated when FCOHb and dv* 38
V(CO) values are keyed in [5].
7-9
Oximetry parameters
Introduction Below is a list of symbols and definitions for all the oximetry parameters
measured, derived or used by the ABL80 FLEX CO-OX analyzer.
Table of The following table lists all the oximetry parameters:
oximetry
parameters Symbol Definition Type Eq.
ctHb Concentration of total hemoglobin in blood. ms
Total hemoglobin includes all types of hemoglobin:
deoxy-, oxy-, carboxy-, met-
FHHb Fraction of deoxyhemoglobin in total hemoglobin in ms/dv
blood.
Deoxyhemoglobin is the part of total hemoglobin
which can bind oxygen forming oxyhemoglobin. It is
also termed reduced hemoglobin, RHb.
FO2Hb Fraction of oxyhemoglobin in total hemoglobin in ms/dv
blood.
FCOHb Fraction of carboxyhemoglobin in total hemoglobin ms
in blood.
FMetHb Fraction of methemoglobin in total hemoglobin in ms
blood
sO2 Oxygen saturation, the ratio between the ms/dv 21
concentrations of oxyhemoglobin and the hemoglobin
minus the dyshemoglobins.
Hct Hematocrit, the ratio between the volume of dv 23
erythrocytes and the volume of whole blood.
7-10
Electrolyte/metabolite parameters
Introduction Below is a list of symbols and definitions for all the electrolyte/metabolite
parameters measured, derived or used by the analyzer.
Table of The following table lists all the electrolyte parameters:

electrolyte/
metabolite Symbol Definition Type Eq.
parameters cK+ Concentration of potassium ions in plasma ms
cNa+ Concentration of sodium ions in plasma ms
cCa2+ Concentration of calcium ions in plasma ms
cCa2+(7.4) Concentration of calcium ions in plasma at pH dv 24
of 7.40
cCl– Concentration of chloride ions in plasma ms
Anion Gap (K+) The concentration difference between the dv 25
cations (cNa+ and cK+) and the measured
anions (cHCO-3 and cCl-)
Anion Gap Concentration difference between cNa+ and dv 26
cCl- + cHCO-3
cGlu Concentration of glucose in plasma ms
(not available in the ABL80 FLEX analyzer
with BASIC software configuration)
cLac Concentration of lactate in plasma ms
(only available in the ABL80 FLEX analyzer
with BASIC software configuration)
mOsm Plasma osmolality dv 27
(not available in the ABL80 FLEX analyzer
with BASIC software configuration or the
ABL80 FLEX CO-OX analyzer with OSM
software configuration)
7-11
Units and ranges

Introduction This section lists all the parameters by symbol, giving the choice of units and
measuring range for each.
The suggested reference ranges, as given in the appropriate reference are also
given for each parameter.
Introduction ......................................................................................... 7-13
Measured parameters .......................................................................... 7-14
Input parameters .................................................................................. 7-16
Derived parameters ............................................................................. 7-17
7-12
Introduction
Symbols The ABL80 FLEX parameters are listed by symbol in three groups: measured,
input, and derived parameters.
Units The units given for each parameter refer to the units available on the analyzer for
that parameter.
Measuring The measuring range for each parameter refers to the range of values which the
ranges analyzer is capable of reporting.
Reference "Reference ranges are valuable guidelines for the clinician, but they should not be
ranges 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].
The reference ranges given in this section are mainly taken from Ref. 10. 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 User-defined critical limits can also be entered into the analyzer software. Refer to
the ABL80 FLEX Operator's Manual, Chapter 9.
7-13
Measured parameters
Table The following table lists all the measured parameters available on all ABL80
FLEX analyzers, independent of configuration.
Symbol Unit Measuring range Numerical format For adults’ arterial blood at 37 °C
of result
Ref. 10 unless otherwise stated
Reference range Sex
pH – 6.00 – 8.00 x.xx 7.35 – 7.45 m, f
pCO2 mmHg 0 – 150 xx 35 – 48 m
32 – 45 f
kPa 0.0 – 20.0 xx.x 4.67 – 6.40 m
4.27 – 6.00 f
pO2 mmHg 0 – 760 xxx 83 – 108 m, f
kPa 0.0 – 101.3 xxx.x 11.07 – 14.40 m, f
cK+ mmol/L 0.0 – 20.0 xx.x 3.4 – 4.5 m, f
meq/L
cNa+ mmol/L 0 – 210 xxx 135 – 146 m, f
meq/L
cCa2+ mmol/L 0.00 – 5.00 x.xx 1.15 – 1.29 m, f [12]
meq/L 0.00 – 10.00 xx.xx 2.30 – 2.58 m, f
mg/dL 0.00 – 20.00 xx.xx 4.61 – 5.17 m, f
cCl– mmol/L 0 – 250 xxx 98 – 106 m, f
meq/L
cGlu mmol/L 0.0 – 75.0 xx.x 3.89 – 5.83 m, f
mg/dL 0 – 1351 xxxx
cLac mmol/L -1.0 – 40.0 xx.x 0.5 – 1.6 m, f
meq/L -1.0 – 40.0 xx.x 0.5 – 1.6 m, f
mg/dL -9 – 360 xxx 4.5 – 14.4 m, f
Hct % 0 – 85 xx 41 – 53 m [24]
36 – 46 f [24]
7-14
The following table lists all the measured parameters available on the ABL80
FLEX CO-OX analyzer.
Symbol Unit Measuring range Numerical format For adults’ arterial blood at 37 °C
of result
Ref. 10 unless otherwise stated
Reference range Sex
ctHb g/dL -1.0 – 27.7 xx.x 13.5 – 17.5 m
12.0 – 16.0 f
g/L -10 – 277 xxx 135 – 175 m
120 – 160 f
mmol/L -1.6 – 44.6 xx.x 8.4 – 10.9 m
7.4 – 9.9 f
sO2 % -2.0 – 102.0 xxx.x 95.0 – 99.0 m,f [11]
Fraction -0.020 – 1.020 x.xxx 0.95 – 0.99 m,f [11]
FO2Hb % -2.0 – 102.0 xxx.x 94.0 – 98.0 m,f
Fraction -0.020 – 1.020 x.xxx 0.940 – 0.980 m,f
FCOHb % -2.0 – 102.0 xxx.x 0.5 – 1.5 m,f
Fraction -0.020 – 1.020 x.xxx 0.005 – 0.015 m,f
FMetHb % -2.0 – 102.0 xxx.x 0.0 – 1.5 m,f
Fraction -0.020 – 1.020 x.xxx 0.000 – 0.015 m,f
FHHb % -2.0 – 102.0 xxx.x ---
Fraction -0.020 – 1.020 x.xxx ---
7-15
Input Parameters
Definition Input parameters are the parameters keyed in by the operator in the patient
information screen.
Table – ABL80 The table below lists all the input parameters available on all versions of the
FLEX analyzers ABL80 FLEX analyzer.
Symbol Unit Input Range

T °C 12.0 – 45.0
°F 54.0 – 113.0
FO2(I) % 0.0 – 100.0
ctHb(m) g/dL 0.0 – 25.0
g/L 0 – 250
mmol/L 0.0 – 15.5
sO2(m) % 0.0 – 100.0
Baro mmHg 0 – 800
Table – ABL80 The table below lists all additional input parameters available on the ABL80 FLEX
FLEX CO-OX CO-OX analyzer.
analyzer only
Symbol Unit Input Range
pO2(v– ) mmHg 0 - 760

kPa 0.0 – 103.3
sO2(v– ) % 0.0 – 100.0

Fraction 0.000 – 1.000
· L/min 0.0-1000.0
Qt
· L/min 0-xxxx
VO2
mmol/min 0.0-xxx.x
VCO mL 0.0-1000.0
FCOHb(1) % 0.0-100.0
Fraction 0.000 - 1.000
FCOHb(2) % 0.0-100.0
Fraction 0.000 - 1.000
7-16
Derived parameters
Definition Derived parameters are calculated or estimated on the basis of measured and keyed
in data. Calculations are made using equations programmed into the analyzer. The
accuracy of the calculations depends on the input parameters keyed into the
analyzer's computer.
Calculated The dependent derived parameter will not be reported if the relevant measured
parameters parameter(s) or input parameter(s) is/are not entered and a default value is not
available.
All ABL80 FLEX systems will preferentially use a measured value before an input
value, an input value before another calculated value, and an input or calculated
value before a default value.
ABL80 FLEX CO-OX systems will preferentially use a measured value before a
default value when calculating derived parameters that depend on CO-oximetry
results.
See Default Values further in this chapter.
7-17
Acid-base The table below lists the acid-base derived parameters.

parameters
Symbol Unit Range / Format Input Sample type
parameter
pH (T) – 6.00 – 8.00 / x.xx T
pCO2(T) mmHg 0 – 150 / xxx T
kPa 0.0 – 20.0 / xx.x
cHCO3–(P) mmol/L 0.0 – 99.0 / xx.x
meq/L
cBase(B) mmol/L ±50.0 / xx.x ctHb(m)
meq/L
cBase(B,ox) mmol/L ±50.0 / xx.x ctHb(m)
meq/L sO2(m)
cBase(Ecf) mmol/L ±30.0 / xx.x
meq/L
cBase(Ecf,ox) mmol/L ±30.0 / xx.x
meq/L
–
cHCO3 (P,st) mmol/L 0.0 – 99.0 / xx.x ctHb(m)
meq/L sO2(m)
ctCO2(B) mmol/L 0.0 – 99.0 / xx.x ctHb(m)
Vol %, 0.0 – 221.9 / xxx.x sO2(m)
mL/dL, 0.0 – 221.9 / xxx.x
ctCO2(P) mmol/L 0.0 – 99.0 / xx.x
Vol %, 0.0 – 221.9 / xxx.x
mL/dL, 0.0 – 221.9 / xxx.x
7-18
Oxygen The table below lists the derived oxygen parameters.

parameters
parameter
pO2(T) mmHg 0 – 760 / xxx T
kPa 0.0 – 101.3 / xxx.x
pO2(A) mmHg 0 – 800 / xxx FO2(I) Arterial
kPa 0.0 – 106.7 / xxx.x Baro Capillary
pO2(A-a) mmHg 0 – 800 / xxx FO2(I) Arterial
kPa 0.0 – 106.7 / xxx.x Baro Capillary
pO2(a/A) Decimal 0.00 – 1.00 / x.xx FO2(I) Arterial
Baro Capillary
pO2/ Decimal 0.00 – 1.00 / x.xx FO2(I) Arterial
FO2(I) Capillary
ctO2 Vol % 0.0 – 45.0 / xx.x ctHb(m)
mL/dL 0.0 – 100.9 / xxx.x
mmol/L 0.0 – 100.9 / xxx.x
RI % 0.0 – 35.0 / xx.x FO2(I) Arterial
Baro Capillary
sO2 % 0.0 – 100.0 / xxx.x
ctHb mmol/L 0.6 – 17.4 / xx.x
g/dL 1.0 – 28.0 / xx.x
g/L 10.0 – 280.0 /
xxx.x
pO2(x) mmHg 0 – 760 / xxx Arterial
kPa 0.0 – 101.3 / xxx.x Capillary
BO2 mmol/L 0.0 – 100.0 / xxx.x
Vol% 0.0 – 224.1 / xxx.x
mL/dL 0.0 – 224.1 / xxx.x
7-19

parameter
· mL/min 0 – 22414 / · Arterial
D O2 Qt
xxxxx
mmol/min Capillary
0.0 – 1000.0 /
xxxx.x
· L/min 0.0 – 100.0 / · Arterial and
Qt VO2
xxx.x
Venous
· mL/min 0 – 22414 / · Arterial and
VO2 Qt
xxxxx
mmol/min Venous
0.0 – 1000.0 /
xxxx.x
FShunt % 0.0 – 100.0 / Arterial and
xxx.x
Venous
0.000 – 1.000 /
Fraction
x.xxx
Qx --- xx.x
V(B) L 0.0 – 20.0 / xx.x VCO,
FCOHb(1),
FCOHb(2)
Electrolyte The table below lists the acid-base derived parameters.

parameters

parameter
cCa2+(7.4) mmol/L 0.20 – 8.10 / x.xx
meq/L, 0.40 – 16.20
mg/dL, 0.80 – 32.40
+
Anion Gap (K ) mmol/L 0.0 – 99.0 / xx.x
meq/L
Anion Gap mmol/L 0.0 – 99.0 / xx.x
meq/L
mOsm mmol/kg 0.0 – 495.0 / xxx.x
7-20
Equations
Introduction This section contains the equations used for all the derived parameters available in
the ABL80 FLEX analyzer versions.
General information ............................................................................ 7-22
List of equations .................................................................................. 7-23
Conversion of units ............................................................................. 7-39
Default values ..................................................................................... 7-41
7-21
General information
NOTE: If 'T' for patient temperature is not stated, the calculation is based on a
temperature of 37.0 °C.
Derived Derived parameters are calculated according to the equations stated.

parameters
If one or more default values have been used in the calculation, the result may
deviate significantly from the true value. The deviation on 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.
Sample type Unless otherwise stated, a parameter will be calculated or estimated irrespective of
the choice in the Sample Analysis screen: ‘Arterial’, ‘Capillary’, ‘Venous’ or
‘Other Fluids’. 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.
Mathematical The following symbols are used in the equations:

symbols
log(x) = log10(x)
ln(x) = loge(x)
7-22
List of equations
List The following is a list of the equations for the derived parameters.
pH(T) Eq. 1 [13]:

pH(T) = pH–[0.0146 + 0.0065 x (pH–7.40)][T-37]
pCO2(T) Eq. 2 [4]:

pCO2(T) = pCO2 x10[0.021x(T-37)] mmHg
cHCO3–(P) Eq. 3 [5]:

(pH − pK p )
cHCO3–(P) = 0.23 x pCO2 x 10 mmol/L
where:
[
pK p = 6.125 − log 1 + 10(pH −8.7 ) ]
pCO2 is expressed in kPa
cHCO3–(P) includes ions of hydrogen carbonate, carbonate and carbamate in the
plasma
cBase(B) Eq. 4 [4,14]:

2 −
 8a '−0.919   0.919 − 8a '  24.47 − cHCO 3 (5.33)
cBase(B) = 0.5 x   + 0.5x   − 4x
 a'   a'  a'
mmol/L
where:
ctHb is expressed in mmol/L
Eq. Description
4.1 a' = 4.04 x 10-3+4.25 x 10-4 ctHb
4.2  (pH (st ) − 6.161) 
cHCO3–(5.33) = 0.23 x 5.33 x 10  
 0.9524
4.3  5.33   pH(Hb) − pH 


pH(st) = pH+log  x
 pCO   log pCO ( Hb) − log(7.5006 pCO ) 
 2  2 2 
4.4 pH(Hb) = 4.06 x 10-2 ctHb + 5.98 – 1.92 x 10(-0.16169ctHb)

4.5 Log pCO2(Hb) = –1.7674 x 10-2 ctHb + 3.4046 + 2.12 x 10(-0.15158ctHb)
7-23
cBase(B,ox) Eq. 5 [4]:

cBase(B,ox) = cBase(B) – 0.3062 x ctHb x (1 – sO2)
If ctHb is not measured, derived or keyed in, the default value will be used.
If not measured, sO2 is calculated from equation 20 or 21.
cBase(Ecf) Eq. 6 [5]:

cBase(Ecf) = cBase(B) for ctHb = 3 mmol/L
cBase(Ecf,ox) Eq. 7:
cBase(Ecf,ox) = cBase(B,ox) for ctHb = 3 mmol/L
cHCO3–(P,st) Eq. 8 [4,14]:

–
cHCO3 (P,st) = 24.47 + 0.919 x Z + Z x a' x (Z–8) mmol/L
where:
sO2 is expressed as a decimal fraction
Eq. Description
8.1 a' = 4.04 x 10-3 + 4.25 x 10-4 x ctHb
8.2 Z = cBase(B) – 0.3062 x ctHb x (1 – sO2)
ctCO2(B) Eq. 9 [5]:
ctCO 2 (B) = 9.286 x10− 3 xpCO 2 xctHbx 1 + 10 [ (pH Ery − pK Ery )

]
 ctHb  mmol/L
+ ctCO 2 (P) x 1 − 
 21.0 
where:
Eq. Description
9.1 pHEry = 7.19 + 0.77 x (pH – 7.40) + 0.035 x (1 – sO2)
9.2 [
pK Ery = 6.125 − log 1 + 10
(pH Ery − 7.84 − 0.06 xsO 2 )
]
9.3 ctCO2(P) = 0.23 x pCO2 + cHCO3–(P)
7-24
ctCO2(P) Eq. 10 [4, 5]:

ctCO 2 (P) = 0.23 × pCO 2 + cHCO3 (P) mmol/L
pO2(T) Eq. 11 [25] Used in the ABL80 FLEX analyzer only:

 
 
 1 
 0.0252 x + 0.00564  x (T − 37 )
   pO 
3.88  
  0.243 x  2
 +1  
   100   
pO 2 (T ) = pO 2 x10  
mmHg
pO2(T) Eq. 12 [16, 17] Used in the ABL80 FLEX CO-OX analyzer only:
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 39 and 40 in
the section Oxyhemoglobin Dissociation Curve further in this chapter).
pO2(T) is calculated by a numerical method using:
t i (T ) = ctHb × (1- FCOHb - FMetHb) × sO 2,i (T ) + αO 2 (T ) × pO 2,i (T )
where
Eq. Description See…

12.1 S = ODC(P,A,T) Eq. 40
12.2 S × (1- FMetHb) − FCOHb Eq. 39.12
sO 2,i (T ) =
1- FCOHb - FMetHb
12.3 P Eq. 39.10
pO 2 ,i (T ) =
FCOHb
1+
sO 2,i (T ) × (1 − FCOHb − FMetHb)
αO 2 =9.83×10 −3 e [−1.15×10 (T -37.0 )+ 2.1×10 −4 ×( T -37.0 )2 ]

−2
12.4
12.5 P is the variable during iteration.

12.6 ∂pH
A=ac-1.04 × × (T -37.0 )
∂T
12.7 T= patient temperature in oC (keyed-in).
∂pH
. × 10 − 2 − 6.5 × 10 − 3 × ( pH (37) − 7.40)
12.8
= − 146
∂ (T )
When t i (T ) = t i (37.0), then pO 2,i (T ) = pO 2 (T )
7-25
pO2(A) pO 2 ( A) = FO 2 ( I ) x ( p (amb) − 47 )
Eq. 13 [25] mmHg
− pCO 2 x[1.25]
where:
FO2(I) is expressed as a decimal fraction
pCO2 is expressed in mmHg
If FO2(I) is not entered, it is set to the default value of 0.2095.
The calculation requires selecting the sample type “Arterial”.
pO2(A-a) Eq. 14
pO2(A-a) = pO2(A) – pO2(a) mmHg or kPa
pO2(a/A) Eq. 15
pO 2 ( a )
pO 2 ( a / A ) = decimal fraction
pO 2 (A)
The calculation requires selecting the sample type as “Arterial” or “Capillary”.
ctO2 Eq. 16 [5] Used in the ABL80 FLEX analyzer only:

ctO2 = (1.39 x ctHb) x sO2 + (0.0031 x pO2) Vol%
where:
ctHb is expressed in g/dL
pO2 is expressed in mmHg
ctO2 cannot be calculated on the basis of a default ctHb value. The result will be
reported as not derived (N/D).
ctO2 Eq. 17 [5] Used in the ABL80 FLEX CO-OX analyzer with CO-OX software
configuration:
ctO 2 = αO 2 × pO 2 + sO 2 × (1 − FCOHb − FMetHb) × ctHb mmol/L
αO2 is the concentrational solubility coefficient for O2 in blood (here set to
9.83 x 10−3 mmolL–1kPa–1 at 37 oC [5, 19].
7-26
ctO2 Eq. 18 [5] Used in the ABL80 FLEX CO-OX analyzer with OSM software
configuration and reflects the oxygen bound to hemoglobin only. The calculation
contains no contribution from the oxygen dissolved in plasma:
ctO 2= sO 2 × (1 − FCOHb − FMetHb) × ctHb mmol/L
RI Eq. 19
pO 2 (A) − pO 2 (a )
RI = x100 %
pO 2 (a )
sO2 Eq. 20 Used in the ABL80 FLEX analyzer only:
((pO ) + 150xpO ') ' 3

sO 2 =
((pO ) + 150xpO )
2 2
x100 %
' 3
+ 23400
'
2 2
where
Eq. Description
pO 2 = pO 2 x10(0.48 x (pH − 7.4 )− 0.0013 x (cHCO 3 − 25 ))

−
20.1 '
sO2 Eq. 21 Used in the ABL80 FLEX CO-OX analyzer only:

The ODC is determined as described in equation 39 (points I and III). See the section
Oxyhemoglobin Dissociation Curve further in this chapter.
S × (1 − FMetHb) − FCOHb
sO 2 =
1 - FCOHb - FMetHb
where
Description See…
S = ODC(P,A,T)
pO 2 × FCOHb Eq. 39.9
P = pO 2 +
sO 2 × (1 − FCOHb − FMetHb)
A=a
T = 37.0 oC
7-27
ctHb Eq. 22
ctHb = 
(
 Hct
100
)
− 0.0083 
 x1.6114 g/dL
 0.0485 
 
Hct Eq. 23 [15]

Hct = 0.0485 × ctHb + 8.3 × 10-3
Hct cannot be calculated on the basis of a default ctHb value. The result will be
cCa2+(7.4) Eq. 24 [12]

cCa2+(7.4) = cCa2+[1 – 0.53 x (7.40 – pH)] mmol/L
Due to biological variations this equation can only be used for a pH value in the
range 7.2 - 7.6.
+
Anion Gap (K ) Eq. 25
+ + + – –
Anion Gap (K ) = cNa + cK – cCl – cHCO3 mmol/L
Anion Gap Eq. 26

+ – –
Anion Gap = cNa – cCl – cHCO3
mOsm Eq. 27 [26]

+
mOsm = 2cNa + cGlu
pO2(a)/FO2(I) Eq. 28
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
the calculation requires entering the sample as “Arterial” or “Capillary”.
p50 Eq. 29 [Refer to ODC equation]
P
p50 =
FCOHb
1+
0.5 × (1- FCOHb - FMetHb)
7-28
where
Description See...
P = ODC(S,A,T) Eq. 40
0.5 × (1 − FCOHb - FMetHb) + FCOHb Eq. 39.11
S=
1- FMetHb
A=a
T = 37.0 oC Eq. 39.13
p50(st) Eq. 30:

p50 is calculated for pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF = 0.
The ODC is determined as described in equations 39-40 in the section
Oxyhemoglobin Dissociation Curve, see equation 40 further in this chapter.
p50(st) = ODC(S,A,T)
where
Description See…
S = 0.5 Eq. 39.11
A = a6 corresponds to pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, Eq. 39.13
FMetHb = 0, FHbF = 0
T = 37.0 oC
pO2(x) Eq. 31 [8]:

(or px) The ODC is determined as described in equations 39-40 in the section
pO2(x) is calculated by a numerical method, using:

30.1 S = ODC(P,A,T) Eq. 40
30.2 S × (1 − FMetHb) − FCOHb Eq. 39.12
sO 2,i =
1 − FCOHb − FMetHb
30.3 P Eq. 39.10
pO 2,i =
FCOHb
1+
sO 2,i × (1 − FCOHb − FMetHb)
30.4 t i = ctHb × (1 − FCOHb − FMetHb) × sO 2,i +

+ 9.83 × 10 − 3 × pO 2,i
30.5 A=a
30.6 T = 37 oC
7-29
When ti = ctO2 – 2.3 mmol/L, then pO2,i = pO2(x), where ctO2 is determined as
described in equation 27.
pO2(x) cannot be calculated on the basis of a default ctHb value. The result will be
pO2(x) can only be calculated if the measured sO2(a) ≤ 0.97 (or p50(st) keyed in).
The calculation requires entering the sample type as "Arterial" or "Capillary".
BO2 Eq. 32 [7]:

BO2 = ctHb × (1 − FCOHb − FMetHb)
BO2 cannot be calculated on the basis of a default ctHb value. The result will be
· Eq. 33:
D O2
. .
D O 2 = ctO 2 × Q t
· ·
Q t is the cardiac output and is an input parameter for calculation of D O2.
· ·
If Q t is not keyed in, D O2 will not be calculated.
The result will be reported as not derived (N/D).
The calculation requires entering the sample type as “Arterial” or “Capillary”.
· Eq. 34:
Qt
.
. V O2
Qt =
ctO 2 ( a − v)
· ·
If V O2 is not keyed in, Q t will not be calculated.
· Eq. 35:
VO2
. .
V O 2 = Q t × ctO 2 (a − v )
· ·
If Q t is not keyed in, VO2 will not be calculated.
7-30
FShunt Eq. 36 [5]:

ctO 2 (c) − ctO 2 (a )
FShunt =
ctO 2 (c) − ctO 2 ( v)
and
Eq. Description
36.1 ctO 2 (A ) − ctO 2 (a )
FShunt ≅
ctO 2 (A ) − ctO 2 ( v)
−1
36.2  ctO 2 (a ) − ctO 2 ( v ) 
FShunt = 1 + 
 ctO 2 (A ) − ctO 2 (a ) 
where
ctO2(c): total oxygen in pulmonary capillary blood
ctO2(a): total oxygen in arterial blood
ctO2(A): total oxygen in alveolar air. Oxygen tension = pO2(A).
ctO2(v– ): total oxygen in mixed venous blood

36.3 ctO 2 (a ) = 9.83 × 10 −3 pO 2 (a) + ctHb × (1 − FCOHb − FMetHb ) × sO 2 (a)
36.4 ctO 2 (A) = 9.83 × 10 −3 pO 2 (A) + ctHb ×

(1 − FCOHb − FMetHb ) × sO 2 (A)
7-31
36.5 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
pO2(A): oxygen tension in alveolar blood. See equation 13.
pO (v– ): oxygen tension in mixed venous blood; measured and then
2
entered
sO2(a): oxygen saturation in arterial blood; can be measured
sO2(A): oxygen saturation in (alveolar) blood calculated from equation
39 where P = pO2(A). If sO2(a) > 0.97, a keyed-in p50(st) will be used
to determine the ODC. If sO2(a) > 0.97 and no p50(st) has been keyed
in, the default value (3.578 kPa) will be used to determine the ODC.
sO (v– ): oxygen saturation in mixed venous blood
2
If not keyed in, it will be calculated from equation 21 where P = pO2(v– ).

If sO2(a) > 0.97, a keyed-in p50(st) will be used to determine the ODC.
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 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 36.2
Eq. 37 [8]:
Qx The ODC is determined as described in equations 39 and 40 in the section
2.3
Qx =
ctO 2 (a ) − t i
37.1 t i = ctHb × (1 - FCOHb - FMetHb) × sO 2, i + 9.83 × 10 −3 pO 2 (5)
37.2 pO2(5) = 5.00 kPa

37.3 S = ODC(P,A,T)
37.4  FCOHb  Eq. 39.9
P = pO 2 (5) × 1 + 
 sO 2,i × (1 − FCOHb − FMetHb ) 
37.5 S × (1 − FMetHb) − FCOHb Eq. 39.12
sO 2,i =
1 - FCOHb - FMetHb
37.6 A=a
37.7 T = 37.0 oC
7-32
ctO2(a) is determined as described in equation 18.

Qx cannot be calculated on the basis of a default ctHb value (result will be reported as
not derived (N/D).
Qx can only be calculated if the measured sO2(a) ≤ 0.97 (or if p50(st) is keyed in).
The calculation requires entering the sample type as “Arterial” or “Capillary”.
V(B) Eq. 38 [5]:

1 × 10 3 × V (CO)
V ( B) =
24 × ( FCOHb(2) − FCOHb(1)) × 0.91 × ctHb
Eq. Description
38.1 V (CO)
V ( B) =
2.184 × 10 × ( FCOHb(2) − FCOHb(1)) × ctHb
-2
38.2 V(CO) = volume (in mL) of carbon monoxide injected according to the
procedure and the value keyed in
38.3 FCOHb(1) = fraction of COHb measured before the CO injection
38.4 FCOHb(2) = fraction of COHb measured after the CO injection
7-33
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. 39 [16, 18]:
[ (
y − y o = ( x − x o ) + h × tanh k o x − x o )]
where ko = 0.5343
Eq. Description
39.1 x = ln p
39.2 s
y = ln
1- s
39.3 so
y o = ln where so = 0.867
1 - so
39.4 x o = x oo + a + b = ln( p oo ) + a + b where poo = 7 kPa
The actual position of the ODC in the coordinate system (ln(s/(1–s)) vs ln(p)) used
in the mathematical model, is expressed by equations 39.3 and 39.4.
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
reference the default value for p50(st) = 3.578 kPa, which is traditionally considered the
position most likely value of p50 for adult humans under standard conditions, namely:
pH = 7.40
pCO2 = 5.33 kPa
FCOHb, FMetHb, FHbF = 0
cDPG = 5 mmol/L
7-34
The ODC The ODC displacement which is described by "a" and "b" in the coordinate system
displacement (ln(s/(1–s))vs ln(p)), is given by the change in p50 from the default to its actual
value in a more common coordinate system (sO2, pO2).
Eq. Description
39.5 p
x − x o = ln −a−b
7
39.6 h = ho + a where ho = 3.5
39.7 b = 0.055 × (T − T o ) To = 37 oC
39.8 p = pO 2 + M × pCO
where M × pCO is taken from the Haldane equation [20]:
pO 2 pCO
=M× , to give eq. 39.9
cO 2 Hb cCOHb
39.9 pO 2  FCOHb 
p = pO 2 + × or equation 39.10
sO 2  1 - FCOHb - FMetHb 
39.10
pO 2 =
[
p × sO 2 × (1 − FCOHb − FMetHb) ]
1 + FCOHb
The ordinate, s, may loosely be termed the combined

oxygen/carbon monoxide saturation of hemoglobin and is
described by equation 39.11 below:
Eq. Description
39.11 cO 2 Hb + cCOHb
s=
cO 2 Hb + cCOHb + cHHb
or
sO 2 × (1 - FCOHb - FMetHb) + FCOHb
=
1 − FMetHb
39.12 s × (1 - FMetHb) − FCOHb
sO 2 =
1 − FCOHb − FMetHb
7-35
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 39.13), 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).
Eq. Description
39.13 a = ac + a6
39.14 ac = a1 + a2 + a3 + a4 + a5
39.15 a1 = −0.88 × (pH − 7.40)
39.16 pCO 2
a2 = 0.048 × ln
5.33
39.17 a3 = −0.7 × FMetHb
39.18 a4 = (0.06 − 0.02 FHbF) × (cDPG − 5)
39.19 a5 = −0.25 × FHbF
Determining the
actual Step Description
displacement I: pO2, sO2 can be used.
If sO2 > 0.97, the calculation is based on II or III – see
below.
Coordinates (P0, S0) are calculated from equations (39.9)
and (39.11).
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).
The magnitude of the shift is "a6".
7-36
Step Description
II: sO2 > 0.97 (or erroneous) and p50(st) is keyed in.
Coordinates (P0, S0) are calculated from (p50(st), 0.5)
using equations 39.9 and 39.11.
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 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.
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
"ac".
NOTE: The curves are used only to illustrate the principles of the ODC determination
7-37
Coordinates on Calculation of a set of coordinates on the ODC is symbolized by:

the ODC
Eq. 40:
S = ODC(P, A, T) or P = ODC(S, A, T)
These equations are symbolic representations of the relationship between
saturation (S), tension (P), displacement (A) and temperature (T).
To calculate S or P and to further calculate sO2 and pO2, the other variables should
be specified. S and P are calculated using numerical methods.
P is input to equation 39.1.
S is input to equation 39.2.
A is input to equation 39.5.
T is input to equation 39.7.
7-38
Conversion of units
SI-units Standard international units (SI units) are not always the most familiar unit in
certain geographical areas. The user can customize the reported unit for all
measured, derived, and input values.
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 (°C ) + 32 or
5
5
T(°C) = T (°F ) − 32
9
+ +
cK+, cNa+, cCl– cX (meq/L) = cX (mmol/L) where: X is K , Na or Cl–.
cCa2+ cCa2+ (meq/L) = 2 x cCa2+ (mmol/L) or

cCa2+ (mg/dL) = 4.008 x cCa2+ (mmol/L)
cCa2+ (mmol/L) = 0.5 x cCa2+ (meq/L) or
cCa2+ (mmol/L) = 0.2495 x cCa2+ (mg/dL)
Pressure p (mmHg) = p(torr) = 7.500638 x p(kPa)

p (kPa) = 0.133322 x p(mmHg) = 0.133322 x p(torr)
cGlu cGlu (mg/dL) = 18.016 x cGlu(mmol/L)

cGlu (mmol/L) = cGlu(mg/dL) / 18.016
cLac cLac (mg/dL) = 9.008 * cLac (mmol/L)

cLac (mmol/L) = 0.11101 * cLac (mg/dL)
cLac (meq/L) = cLac (mmol/L)
ctHb [4]
ctHb (g/dL) = 1.61140 x ctHb (mmol/L)
ctHb (g/L) = 16.1140 x ctHb (mmol/L) or
ctHb (mmol/L) = 0.62058 x ctHb (g/dL)
ctHb (mmol/L) = 0.062058 x ctHb (g/L)
7-39
ctO2 ctO2 (mmol/L) = 0.4462 x ctO2 (Vol%)

ctO2 (Vol%) = 2.241383 x ctO2 (mmol/L)
ctCO2, ctO2, Vol % = 2.241383 × (mmol/L)

ctO (a−v– ), BO
2 2
Vol % = mL/dL
mmol/L = 0.4462 × (mL/dL)
Weight pounds (lbs) = 2.2046 × kg
NOTE: All unit conversions are performed by the analyzer.
7-40
Default values
Values The following default values are used in the ABL80 FLEX analyzers, if other
values are not keyed-in and default values are allowed.
T = 37.0 °C (98.6 °F)
FO2(I) = 0.2095 (21.0 %)
QC Temperature = 25 °C
RQ = 0.86
ctHb = 9.3087 mmol/L (15.0 gdL or 150 gL)
FCOHb = 0.004 (0.4%)
FMetHb = 0.004 (0.4%)
p50(st) = 3.578 kPa (26.84 mmHg)
7-41
References
List of 1. The Deep PictureTM, critical information from blood gas analysis.
references Copenhagen: 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, Gøthgen 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, Gøthgen 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, Gøthgen IH.
Arterial oxygen status determined with routine pH/blood gas equipment
and multi-wavelength hemoximetry: reference values, precision and
accuracy. Scand J Clin Lab Invest 1990; 50, Suppl 203: 57-66. 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.
7-42
15. Kokholm G. Simultaneous measurements of blood pH, pCO2, pO2 and

concentrations of hemoglobin and its derivatives – a multicenter study.
Scand J Clin Lab Invest 1990; 50, Suppl 203: 75-86. Available as AS107.
16. Siggaard-Andersen O, Wimberley PD, Gøthgen 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, Gøthgen IH, Fogh-Andersen N,
Rasmussen JP. Variability of the temperature coefficients for pH, pCO2
and pO2 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. Brock A. Erythrocytter, volfr. In: Olesen H, ed. Kompendium i
laboratoriemedicin. Copenhagen: Amtrådsforeningen Danmark 1998; 109.
25. CLSI document C46-A Vol. 21 No. 14, Blood gas and pH analysis and
related measurements, Clinical and Laboratory Standards Institute, 940
West Valley Road, Suite 1400, Wayne, PA 19087.
26. Burton David Rose, Clinical physiology of acid-base and electrolyte
disorders, 4th ed. 1994: 224-225.
7-43
8. Solutions
Introduction This chapter gives information on all solutions used with all ABL80 FLEX
analyzer versions, their composition, use, and consumption.
The Certificate of Traceability for all solutions is found at the end of the chapter.

General information ............................................................................................8-2
Solutions .............................................................................................................8-3
Certificate of traceability ....................................................................................8-5
8. Solutions ABL80 FLEX reference manual
General information
Introduction All ABL80 FLEX analyzer versions utilize a solution pack for all calibrations,
QC, and flush procedures and for the collection of waste fluids.
Solution pack The solution pack contains four foil pouches each filled with calibration solution.
These pouches provide multiple solution levels for sensor calibration.
Additionally, solution 1 is used for sample flushing procedures. A fifth pouch
provides a receptacle for the collection of all waste fluids.
In vitro All the solutions described in this chapter are for in vitro diagnostic use.
diagnostic use
Expiration date The shelf-life expiration date for the solution pack is found on the pack label. The
expiration date is labeled with an "Install By" symbol ( ) followed by a date in
year-month-day format (e.g. 2006-04-23). A solution pack may be installed up to
this expiration date and be used on the analyzer for up to 30 days (or 60 days
depending on the in-use life of the pack installed) beyond this date or until one or
more calibration fluids are fully consumed, whichever occurs first.
Expiration Date
Storage The solution pack storage temperature range for all versions (except REF 944-341)
is 5 °C to 25 °C (41 to 77 °F). The solution pack storage temperature range for
REF 944-341 is 2 °C to 25 °C (36 to 77 °F). The storage and operating altitude
range is sea level to 2290 meters. When stored at this temperature and altitude, the
solution pack is stable throughout the shelf-life period, if the protective tape over
the fluid ports remains intact. Beyond this date, the solutions will remain stable
and may be used for up to the maximum allowed number of days, when properly
installed onto the analyzer.
Safety Data Material Safety Data Sheets (MSDS) for all calibration solutions are available
Sheets from your Radiometer distributor.
Re-ordering Information for re-ordering solution packs from Radiometer can be found in the
ABL80 FLEX Operator’s Manual, Chapter 13.
8-2
ABL80 FLEX reference manual 8. Solutions
Solutions
Use The four solutions contained in the pouches of the solution pack are used for
calibration and quality control of all analytes. During sample analysis and quality
control measurements this solution also acts as a flush, removing the sample from
the sensor cassette measuring chamber. This solution is also used to manually
flush the measuring chamber when using the Rinse function.
Pouch volume
Pouch 1 2 3 4
Volume 440 mL 220 mL 220 mL 220 mL
Cycles 230 110 110 110
Pouch volume,
OSM software Pouch 1 2 3 4
configuration Volume 440 mL 220 mL 220 mL 220 mL
only
Cycles 330 150 150 150
Composition The solution composition includes organic buffers and inorganic salts which
provide the following substances with approximate concentrations as given below:
Concentrations
Substance Units Solution 1 Solution 2 Solution 3 Solution 4
pH 7.40 6.90 7.60
pCO2 mmHg 35 75 15
pO2 mmHg 150 45 210
+
cNa mmol/L 145 104 160
+
cK mmol/L 4 8.5 2.5
cCa2+ mmol/L 1.09 2.26 0.55
cCl– mmol/L 114 79 130 16
cGlu mmol/L 0 15 5
Hct % 12 63
All solutions are buffered for stability.
8-3
Composition – The solution composition for the ABL80 FLEX CO-OX solution pack (with CO-
ABL80 FLEX OX software configuration) is comparable to the concentrations listed in the table
CO-OX above. One exception is cCl– in solution 4, which has a concentration of
analyzer with approximately 74 mmol/L. In addition, dye is present in solution 2 and solution 4
CO-OX for use in the oximetry system.
software
configuration
Composition – The solution composition of the solution pack for the ABL80 FLEX analyzer with
ABL80 FLEX BASIC software configuration is comparable to the concentrations listed for
analyzer with solution 1 and 2 in the table above, but without cGlu. Solution packs compatible
BASIC software with lactate measurement also contain lactate in Solution 2 with a concentration of
configuration approximately 8.0 mmol/L
Composition – The solutions in the solution pack for the ABL80 FLEX CO-OX analyzer with
ABL80 FLEX OSM software configuration include a clear solution for performing blank
CO-OX calibrations and rinsing the system. Pouches two and four also contain dyes which
analyzer with are used to perform quality control measurements in the oximetry system.
OSM software
configuration
NOTE: The analyte concentrations for each solution are included in the smart chip
contained on each solution pack. The values are read into the analyzer when the
solution pack is installed onto an analyzer.
Smart chip
Additives All solutions contain a preservative and a surfactant.
8-4
Certificate of traceability
8-5
8-6
8-7
8-8
8-9
9. Interfacing facilities
Introduction This chapter provides information about interfacing all ABL80 FLEX analyzer
versions with external devices.

Connecting an alphanumeric keyboard ..................................................9-3
Connecting the external barcode scanner ..............................................9-4
Connecting to a network ........................................................................9-5
Additional connections ..........................................................................9-6
9. Interfacing facilities ABL80 FLEX reference manual
General information
Introduction This chapter informs the user about the requirements and procedures for
interfacing all ABL80 FLEX analyzer versions with external devices. The scope of
use and data format (if applicable) will also be discussed.
The following may be connected to the analyzer via the ports at the rear of the
analyzer:
• An alphanumeric keyboard
• A barcode scanner
NOTE: To obtain specific information concerning the location and specifications of all
the communication ports on the analyzer, refer to Chapter 2 in the Operator's
Manual.
9-2
ABL80 FLEX reference manual 9. Interfacing facilities
Connecting an alphanumeric keyboard
Scope of use An external alphanumeric keyboard connected to the ABL80 FLEX analyzer (any
version) may be used to enter data into input fields during analyzer use or used for
certain service activities. However, to select individual touch-keys on the
analyzer’s screen, the operator must touch the analyzer’s screen.
Material An IBM enhanced personal computer keyboard (PS2) or a USB style is the sole
required item that is required for connection to the analyzer.
NOTE: The keyboard layout must correspond to the language version used by the
analyzer.
Procedure for Follow the instructions below to connect an IBM keyboard to the analyzer.
connecting an
IBM keyboard Step Action
1. Shut down the analyzer by performing the following:
• Select Menu > Shutdown
• At the prompt, press Yes
• Allow the analyzer to completely power down
2. If an external barcode scanner is already connected, disconnect it
from the analyzer.
3. Connect the keyboard to the barcode scanner / keyboard port (PS2
port) at the rear of the analyzer. The port is labeled with the
symbol.
4. Re-start the analyzer.
Procedure for Follow the instructions below to connect a USB keyboard to the analyzer.
connecting a
USB keyboard Step Action
1. Connect the USB keyboard to either of the USB ports at the rear of
the analyzer.
2. Wait a few seconds for the system to recognize the keyboard.
9-3
Connecting the external barcode scanner
Scope of use An external barcode scanner can be connected to the ABL80 FLEX analyzer (any
version) and may be used to scan a variety of information including patient
information and user information. Barcodes may be scanned into the analyzer
anytime the cursor is in an active input field or the analyzer screen prompts for a
barcode scan.
Material The only external barcode scanner approved for use on this device is the
required Radiometer barcode scanner (gun-style) that is supplied by the manufacturer.
Replacement scanners may be ordered from Radiometer.
NOTE: The barcode scanner, which has a PS2 interface, must be connected to the
analyzer in accordance with the EN50022/4.1987, EN50082-1/1992 standards.
Procedure for Follow the instructions below to connect the barcode scanner to the analyzer.
connecting the
barcode scanner Step Action
1. Connect the external barcode scanner to the barcode scanner /
keyboard port at the rear of the analyzer. The port is labeled with the
symbol.
2. Shut down the analyzer by performing the following:
• Select Menu > Shutdown
• At the prompt, press Yes
• Allow the analyzer to completely power down
3. Re-start the analyzer
9-4
ABL80 FLEX reference manual 9. Interfacing facilities
Connecting to a network
Scope of use All versions of the ABL80 FLEX analyzer are capable of bi-directional
communication with information systems such as the Hospital Information System
(HIS) or the Laboratory Information System (LIS). The connection of the analyzer
to such an information system by means of a network enables the user to exercise
greater control over the amount of patient data circulating within the hospital. Bi-
directional communication allows the analyzer to query a network database for
patient identification and order information. This provides added assurance of
proper patient identification.
Type of data The types of information that can be communicated via a network between the
transmitted central computer controlling the information system and the analyzer are:
• Patient results
• Quality control results
• Calibration data
• System messages
Material Connect the analyzer to a network using the RJ45 connector (10/100 Ethernet)
required
or utilizing one of two USB ports .
Connecting the Contact your Radiometer Representative for information regarding network
analyzer to a connections. Information on available communication protocols for connection to
network other network configurations can be found in the Communication Protocol
Specifications for Radiometer Products (REF: 989-329).
9-5
Additional connections
External An external monitor can be connected to the analyzer to display the user interface
monitor on a larger screen. This can be useful during user training. The monitor connector
is a VGA output labeled with the following symbol:
9-6
Index
A
Absorbance ........................................................................................................................................................ 4-77
Acid-base parameters .......................................................................................................................................... 7-5
Amperometric Measuring Principle..................................................................................................................... 4-7
Amperometry ...................................................................................................................................................... 4-4
B
Bias .................................................................................................................................................................... 6-10
C
Calibration
pO2 electrode ................................................................................................................................................ 4-65
Calibration equation .......................................................................................................................................... 4-14
Calibration of the conductivity electrode .......................................................................................................... 4-71
Sensitivity....................................................................................................................................................... 4-71
Sensitivity limits ............................................................................................................................................. 4-72
Calibration of the electrolyte sensors ............................................................................................................... 4-54
Measurement ................................................................................................................................................ 4-55
Sensitivity....................................................................................................................................................... 4-54
Calibration of the Glu sensor ............................................................................................................................. 4-60
Sensitivity....................................................................................................................................................... 4-60
Calibration of the Lac sensor
Measurement ................................................................................................................................................ 4-65
Sensitivity....................................................................................................................................................... 4-65
Calibration of the optical system ....................................................................................................................... 4-79
Measurement and corrections ...................................................................................................................... 4-83
Calibration of the pCO2 sensor .......................................................................................................................... 4-38
Calibration levels ........................................................................................................................................... 4-38
Sensitivity....................................................................................................................................................... 4-39
Calibration of the pH sensor .............................................................................................................................. 4-29
Sensitivity....................................................................................................................................................... 4-29
Calibration of the pO2 sensor ............................................................................................................................ 4-47
Sensitivity....................................................................................................................................................... 4-47
CD drive ............................................................................................................................................................... 3-3
Certificate of traceability ..................................................................................................................................... 8-5
Composition......................................................................................................................................................... 8-3
Conductivity electrodes ..................................................................................................................................... 4-67
Conductometry .................................................................................................................................................... 4-4
Construction of the conductivity electrode ....................................................................................................... 4-68
Diagram ......................................................................................................................................................... 4-68
Location within sensor array ......................................................................................................................... 4-68
Parts and description ..................................................................................................................................... 4-68
Construction of the electrolyte sensors ............................................................................................................ 4-51
Index ABL80 FLEX reference manual
Diagram ......................................................................................................................................................... 4-51

Construction of the Glu sensor .......................................................................................................................... 4-57
Diagram ................................................................................................................................................ 4-57, 4-58
Construction of the Lac sensor
Diagram ......................................................................................................................................................... 4-62
Location within the sensor array ................................................................................................................... 4-62
Construction of the pCO2 sensor ....................................................................................................................... 4-33
Diagram ......................................................................................................................................................... 4-33
Construction of the pO2 sensor ......................................................................................................................... 4-43
Diagram ......................................................................................................................................................... 4-43
Conversion of units ............................................................................................................................................ 7-39
Correcting for HbF interference ........................................................................................................................ 4-80
Correcting for other interferences .................................................................................................................... 4-82
Corrections
pCO2 ............................................................................................................................................................... 4-41
pH .................................................................................................................................................................. 4-31
pO2 ................................................................................................................................................................. 4-49
Critical limits ...................................................................................................................................................... 7-13
Cuvette path length ........................................................................................................................................... 4-79
D
Day-to-day variation ............................................................................................................................................ 6-9
Default values .................................................................................................................................................... 7-41
Derived parameters ........................................................................................................................................... 7-17
Documentation .................................................................................................................................................... 1-2
Drift .................................................................................................................................................................... 4-15
E
Electrical contact ................................................................................................................................................. 4-3
Electrode.............................................................................................................................................................. 4-3
Electrode base ..................................................................................................................................................... 4-3
Electrolyte ............................................................................................................................................................ 4-3
Electrolyte sensors............................................................................................................................................. 4-50
Electrolyte/metabolite parameters ................................................................................................................... 7-11
Entering user-defined corrections ....................................................................................................................... 5-3
Equations ........................................................................................................................................................... 7-21
Expiration date .................................................................................................................................................... 8-2
External barcode scanner .................................................................................................................................... 9-4
External monitor .................................................................................................................................................. 9-6
G
Gas tanks ............................................................................................................................................................. 2-2
General measuring principles .............................................................................................................................. 4-4
H
Hemolyzer ..................................................................................................................................................... 2-2, 3-3
I
IBM keyboard ...................................................................................................................................................... 9-3
2
ABL80 FLEX reference manual Index
Imprecision .......................................................................................................................................................... 6-9

Input Parameters ............................................................................................................................................... 7-16
Interfacing facilities ............................................................................................................................................. 9-1
Interference tests .............................................................................................................................................. 6-30
L
Lambert-Beer's law ............................................................................................................................................ 4-76
Limits ..................................................................................................................................... 4-17, 4-18, 4-19, 4-20
List of equations ................................................................................................................................................ 7-23
M
Manual QC samples ........................................................................................................................................... 2-13
Measured parameters ....................................................................................................................................... 7-14
Measurement
Electrolytes .................................................................................................................................................... 4-55
Hct.................................................................................................................................................................. 4-73
Lac .................................................................................................................................................................. 4-66
Oximetry parameters..................................................................................................................................... 4-83
pCO2 ................................................................................................................................................................. 4-40
pH .................................................................................................................................................................. 4-30
pO2 ................................................................................................................................................................... 4-48
pO2 electrode ................................................................................................................................................ 4-66
Measuring principle
Lac sensor ...................................................................................................................................................... 4-63
Measuring principles
Conductivity electrode .................................................................................................................................. 4-69
Electrolyte sensors......................................................................................................................................... 4-52
Glu sensor ...................................................................................................................................................... 4-58
Optical System ............................................................................................................................................... 4-75
pCO2 sensor ................................................................................................................................................... 4-34
pH sensor ....................................................................................................................................................... 4-26
pO2 sensor ..................................................................................................................................................... 4-44
Measuring Principles
Amperometric.................................................................................................................................................. 4-7
General ............................................................................................................................................................ 4-4
Potentiometric ................................................................................................................................................. 4-5
Measuring principles of the Lac sensor ............................................................................................................. 4-63
Measuring process
Manual QC samples ....................................................................................................................................... 2-13
Patient samples ............................................................................................................................................. 2-11
Measuring ranges .............................................................................................................................................. 7-13
Membrane ........................................................................................................................................................... 4-3
N
Nernst equation .......................................................................................................................................... 4-6, 4-53
Network ............................................................................................................................................................... 9-5
O
Optical System ................................................................................................................................................... 4-74
Overview of reference methods .......................................................................................................................... 6-3
Oximetry parameters ........................................................................................................................................ 7-10
Oxygen parameters ............................................................................................................................................. 7-7
Oxyhemoglobin Dissociation Curve (ODC) ........................................................................................................ 7-34
P
Parameters .......................................................................................................................................................... 7-1
Patient samples ................................................................................................................................................. 2-11
3
Index ABL80 FLEX reference manual
Measuring process ......................................................................................................................................... 2-11

pCO2 Sensor ....................................................................................................................................................... 4-32
Performance characteristics ................................................................................................................................ 6-1
Performance test results .......................................................................................................................... 6-12, 6-21
Performance tests ............................................................................................................................................... 6-8
pH sensor ........................................................................................................................................................... 4-24
Diagram ......................................................................................................................................................... 4-25
pO2 Electrode
calibration ...................................................................................................................................................... 4-65
measurement ................................................................................................................................................ 4-66
measuring principle ....................................................................................................................................... 4-63
pO2 sensor ......................................................................................................................................................... 4-43
Potentiometric measuring principle .................................................................................................................... 4-5
Potentiometry ..................................................................................................................................................... 4-4
Pouch volume ...................................................................................................................................................... 8-3
Power supply ....................................................................................................................................................... 3-3
Precision .............................................................................................................................................................. 6-9
Printer unit........................................................................................................................................................... 3-3
R
Range – electrical............................................................................................................................................... 4-20
Reference electrode .......................................................................................................................................... 4-21
Diagram ......................................................................................................................................................... 4-23
Location ......................................................................................................................................................... 4-22
Reference methods ...................................................................................................................................... 6-3, 6-6
Reference ranges ............................................................................................................................................... 7-13
References ................................................................................................................................................ 4-85, 7-42
Re-ordering .......................................................................................................................................................... 8-2
Repeatability ........................................................................................................................................................ 6-9
Reproducibility..................................................................................................................................................... 6-9
S
S0 - Precision ........................................................................................................................................................ 6-9
Safety Data Sheets ............................................................................................................................................... 8-2
SD – Day-to-day variation ..................................................................................................................................... 6-9
Sensitivity........................................................................................................................................................... 4-17
Limits ................................................................................................................................. 4-17, 4-18, 4-19, 4-20
Sensor parameter limits .................................................................................................................................... 4-16
Sensors ................................................................................................................................................................ 4-1
SI-units ............................................................................................................................................................... 7-39
Slope and offset ................................................................................................................................................... 5-4
Solutions ....................................................................................................................................................... 8-1, 8-3
Spectrometer ....................................................................................................................................................... 3-4
Spectrophotometry ............................................................................................................................................. 4-4
Spectrum example ............................................................................................................................................. 4-78
Stability
Electrical ........................................................................................................................................................ 4-18
Temperature .................................................................................................................................................. 4-19
Storage................................................................................................................................................................. 8-2
SX - Reproducibility .............................................................................................................................................. 6-9
Symbols................................................................................................................................................................ 7-4
T
Test apparatus and frequency ............................................................................................................................. 6-5
4
ABL80 FLEX reference manual Index
Testing against a reference method .................................................................................................................... 6-4

tHb calibration frequency .................................................................................................................................. 4-79
The Deep Picture™ .............................................................................................................................................. 7-3
U
USB keyboard ...................................................................................................................................................... 9-3
User-defined corrections ..................................................................................................................................... 5-1
W
Waste removal..................................................................................................................................................... 2-9
Wet section diagram .................................................................................................................................... 2-3, 2-5
Z
Zero point .......................................................................................................................................................... 4-79
5
ABL80 FLEX reference manual Date of issue
Date of issue
Radiometer representative: Manufacturer:
Radiometer Medical ApS

Åkandevej 21
2700 Brønshøj
If you have any questions or need
Denmark
assistance, please contact your local
www.radiometer.com
Radiometer representative.
ABL80 FLEX
reference manual
Publication 201211
Edition A
Code number 996-074

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THIRD-PARTY SOFTWARE AND TRADEMARKS

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Radiometer makes no warranties, express or implied, other than expressly stated.

This document is subject to change without notice.

2012 Radiometer Medical ApS, All rights reserved.

Contents This manual contains the following topics.

ABL80 FLEX documentation.................................................................................. 1-2

Measuring processes .............................................................................................. 2-8

Overview ................................................................................................................ 4-3

Reference electrode .............................................................................................. 4-21

pCO2 Sensor ......................................................................................................... 4-32

pO2 sensor ............................................................................................................ 4-42

The electrolyte sensors ......................................................................................... 4-50

Glucose and Lactate sensors ................................................................................ 4-56

Conductivity electrodes........................................................................................ 4-67

Optical System ..................................................................................................... 4-74

References ............................................................................................................ 4-85

Reference methods ................................................................................................. 6-3

Performance tests ................................................................................................... 6-8

Definitions and symbols......................................................................................... 7-2

Units and ranges ................................................................................................... 7-12

References ............................................................................................................. 7-42

Contents This chapter contains the following topics.

ABL80 FLEX documentation

Contents This chapter contains the following topics.

Contents of wet The main components of the wet section are:

Wet section diagram – ABL80 FLEX analyzer

Item Part Function

Wet section diagram – ABL80 FLEX CO-OX analyzer

Item Part Function

Item Part Function

Contents This section contains the following topics.

Patient samples – ABL80 FLEX analyzer

Patient samples – ABL80 FLEX CO-OX analyzer

Manual QC samples – ABL80 FLEX analyzer

Manual QC samples – ABL80 FLEX CO-OX analyzer

Contents This chapter contains the following topics.

Electronic boards and components

Hemolyzer An ultrasonic hemolyzer, specific to the ABL80 FLEX CO-OX analyzer,

Contents This chapter includes the following topics.

Corrections – pCO2 ..............................................................................4-41

General measuring principles

Potentiometric measuring principle

Diagram The diagram below is a general representation of an electrode chain:

Activity Activity expresses the ‘effective concentration’ of a species and is explained in

Amperometric measuring principle

Diagram The diagram below is a general representation of an amperometric electrode chain

Item Part Description

Measuring The following is an account of the measuring process in an amperometric

Conductometric measuring principle

Diagram The diagram below is a general representation of a conductometric electrode

Contents This section contains the following topics.

Frequency Calibration must be performed at regular intervals so that normal variations in

The calibration equation

Deriving the Each sensor has a unique calibration equation.

Updating The calibration line slope is re-established with every calibration.

Sensor parameter limits

Parameter Sensitivity Range Unit