ABL80 FLEX operator's manual

ABL80 FLEX
operator's
manual
 What is new in this manual?
Update for This manual has been updated with information on the following:
ABL80 FLEX • Centralized User Management
and ABL80
FLEX CO-OX • Failure reporting
analyzers, all • Result Suppression
Software
versions • Support for the AQURE system
 Table of Contents

ABL80 FLEX 1. Introduction

analyzer
2. What is what

3. General software features

4. Sample measurements

5. Calibration

6. Quality Control

7. Data

Operator’s manual 8. Utilities

9. Settings

10. Troubleshooting

11. Sampling

12. Specifications

13. Order information

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,
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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
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Any warranties expressly stated in this document are conditional upon the system being installed,
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 CHANGES
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© 2013 Radiometer Medical ApS. All rights reserved.

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 FONT SOFTWARE END-USER LICENSE AGREEMENT

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 Table of contents

Introduction This manual describes how to operate all versions of the ABL80 FLEX analyzer.

Contents This manual contains the following topics.

1.  Introduction .................................................................................................... 1-1 

Intended use ........................................................................................................... 1-2 
Known interfering substances ............................................................................ 1-10 
Warnings and cautions ........................................................................................ 1-11 
Limitations of use................................................................................................. 1-12 

2.  What is what ................................................................................................... 2-1 

Analyzer front view – ABL80 FLEX analyzer .................................................... 2-2 
Analyzer front view – ABL80 FLEX CO-OX analyzer ...................................... 2-3 
Analyzer rear view................................................................................................. 2-4 
Solution pack .......................................................................................................... 2-5 
Sensor cassette front and rear views .................................................................... 2-8 
Analyzer power .................................................................................................... 2-13 
Installing consumables ........................................................................................ 2-15 

3.  General software features .............................................................................. 3-1 

Touch screen .......................................................................................................... 3-2 
Main menu ............................................................................................................. 3-3 
Analyzer status....................................................................................................... 3-5 
Tutorials ................................................................................................................. 3-8 
Failure report ....................................................................................................... 3-10 
Icons ...................................................................................................................... 3-13 

4.  Sample measurements .................................................................................... 4-1 

General information .............................................................................................. 4-2 
Introducing a blood sample .................................................................................. 4-3 
Sample information ............................................................................................. 4-15 
Patient report ....................................................................................................... 4-20 
Edit patient information...................................................................................... 4-21 
Patient edit log ..................................................................................................... 4-24 
Approval ............................................................................................................... 4-25 
FlexLink................................................................................................................ 4-27 

5.  Calibration ...................................................................................................... 5-1 

General information .............................................................................................. 5-2 
Table of contents ABL80 FLEX operator’s manual

Calibration reports ................................................................................................ 5-4 

tHb calibration ....................................................................................................... 5-6 
Standby mode......................................................................................................... 5-9 

6.  Quality management ...................................................................................... 6-1 

Automatic quality control ..................................................................................... 6-2 
System Checks ....................................................................................................... 6-6 
Analysis Check ....................................................................................................... 6-7 
Manual quality control .......................................................................................... 6-8 
Preparing manual QC solutions ........................................................................... 6-9 
Performing a manual QC measurement ............................................................ 6-10 
Manual QC results............................................................................................... 6-15 
Out of range manual QC results ........................................................................ 6-16 
Manual QC plot ................................................................................................... 6-17 
Reviewing manual QC statistics ......................................................................... 6-19 
Range+ QUALICHECK QC solution ................................................................ 6-20 
RiliBÄK ranges .................................................................................................... 6-22 

7.  Data logs .......................................................................................................... 7-1 

General information .............................................................................................. 7-2 
Logs ......................................................................................................................... 7-4 
Upload..................................................................................................................... 7-5 
Download ................................................................................................................ 7-8 
Data maintenance ................................................................................................ 7-11 
System information.............................................................................................. 7-13 

8.  Utilities............................................................................................................. 8-1 

Installation – sensor cassette ................................................................................. 8-2 
Installation – solution pack ................................................................................... 8-5 
Counter ................................................................................................................... 8-7 
Settings transfer ..................................................................................................... 8-9 
tHb calibration ..................................................................................................... 8-11 
Rinse ..................................................................................................................... 8-12 
Software upgrade................................................................................................. 8-13 
Eject CD ............................................................................................................... 8-14 

9.  Settings ............................................................................................................ 9-1 

Patient ranges......................................................................................................... 9-2 
Manual QC ............................................................................................................. 9-7 
Manual QC ranges................................................................................................. 9-8 
Manual QC lockout ............................................................................................. 9-11 
Manual QC statistical factor............................................................................... 9-13 
ABL80 FLEX operator’s manual Table of contents

Manual QC schedule ........................................................................................... 9-14 

Manual QC temperature..................................................................................... 9-17 
RiliBÄK ranges .................................................................................................... 9-19 
System Cycle schedule ......................................................................................... 9-21 
System Cycle drift ................................................................................................ 9-22 
Standby schedule ................................................................................................. 9-23 
tHb calibration schedule ..................................................................................... 9-25 
Date/time .............................................................................................................. 9-26 
Units ...................................................................................................................... 9-27 
Data communications .......................................................................................... 9-29 
FlexLink................................................................................................................ 9-39 
Analyzer message................................................................................................. 9-41 
System status ........................................................................................................ 9-42 
Correlation ........................................................................................................... 9-44 
Record deletion .................................................................................................... 9-48 
Main menu setup ................................................................................................. 9-49 
Reports ................................................................................................................. 9-52 
Reports – input fields .......................................................................................... 9-53 
Reports – printout ............................................................................................... 9-59 
Reports – report options ..................................................................................... 9-69 
Reports – patient download ................................................................................ 9-71 
System – active parameters................................................................................. 9-72 
System – air detection.......................................................................................... 9-75 
System – analyzer lockout ................................................................................... 9-77 
Security ................................................................................................................. 9-78 

10. Troubleshooting ............................................................................................ 10-1 

Warnings and cautions ........................................................................................ 10-3 
Guidelines ............................................................................................................. 10-4 
Normal fluidics – ABL80 FLEX analyzer ......................................................... 10-5 
Normal fluidics – ABL80 FLEX CO-OX analyzer ........................................... 10-8 
Analyzer cleaning and disinfection .................................................................. 10-10 
Disinfection procedure ...................................................................................... 10-12 
General information – sensor cassette ............................................................. 10-14 
Single versus multiple parameters ................................................................... 10-15 
Single parameter out of range – sensor cassette ............................................. 10-20 
Multiple parameters out of range – sensor cassette ........................................ 10-22 
Possible sources of air contamination .............................................................. 10-23 
CO-oximeter troubleshooting ........................................................................... 10-26 
General error messages ..................................................................................... 10-33 

iii
Table of contents ABL80 FLEX operator’s manual

CO-OX error codes ........................................................................................... 10-53 

Result messages .................................................................................................. 10-58 

11. Sampling ........................................................................................................ 11-1 

Causes of errors in the preanalytical phase ....................................................... 11-2 
Preparation prior to arterial/venous sampling ................................................. 11-5 
Preparation prior to capillary sampling ............................................................ 11-7 
Sampling devices .................................................................................................. 11-8 
CLINITUBES - ABL80 FLEX analyzer ............................................................ 11-9 
Storage and preparation prior to analysis ....................................................... 11-10 
Sampling procedures ......................................................................................... 11-12 
References .......................................................................................................... 11-13 

12. Specifications ................................................................................................ 12-1 

Measured parameters.......................................................................................... 12-2 
Calculated parameters ........................................................................................ 12-4 
Input parameters ................................................................................................. 12-7 
Physical and operating specifications ................................................................ 12-8 
Approvals and compliances .............................................................................. 12-11 
Symbols list......................................................................................................... 12-13 
Patents ................................................................................................................ 12-15 

13. Order information ........................................................................................ 13-1 

ABL80 FLEX analyzer ........................................................................................ 13-2 
ABL80 FLEX CO-OX analyzer.......................................................................... 13-5 
Accessories............................................................................................................ 13-7 
Documentation ..................................................................................................... 13-9 
Samplers ............................................................................................................. 13-10 

Index
Date of Issue
 1. Introduction

Introduction This chapter provides an introduction to all versions of the ABL80 FLEX analyzer.
It describes the usage of the analyzer, lists all possible measured and calculated
parameters, and lists substances known to interfere with the measurements. An
explanation of the use of warnings and cautions is also included.
This manual provides information for both the ABL80 FLEX and the ABL80
FLEX CO-OX analyzers. Features that apply to both analyzers are described only
once. Features that differ between the two analyzers are clearly noted within the
text of this manual.
The ABL80 FLEX analyzer is available in two software configurations: FLEX and
BASIC. Features that apply to both software configurations are described only
once. Features that differ between the two software configurations are clearly noted
within the text of this manual.
The ABL80 FLEX CO-OX analyzer is available in two software configurations:
CO-OX and OSM. Features that apply to both software configurations are
described only once. Features that differ between the two software configurations
are clearly noted within the text of this manual.

In this chapter This chapter covers the following topics:

Intended use ...........................................................................................1-2
Known interfering substances ..............................................................1-10
Warnings and cautions .........................................................................1-11
Limitations of use.................................................................................1-12
1. Introduction ABL80 FLEX Operator's Manual

Intended use
Intended use The ABL80 FLEX analyzer is a portable, automated analyzer that measures pH,
blood gases, electrolytes, glucose, lactate, hematocrit (ABL80 FLEX analyzer
only) and oximetry (ABL80 FLEX CO-OX analyzer only) in whole blood. The
ABL80 FLEX analyzer system is intended for use by trained technologists, nurses,
physicians and therapists. It is intended for use in a laboratory environment, near
patient or point-of-care setting.

WARNING: The user should review the analyzer performance data to assure that the
performance fulfills the user-specific analytical needs.

Human blood All ABL80 FLEX analyzer versions are designed for use with undiluted human
arterial, venous, and capillary whole blood. The ABL80 FLEX analyzer (both
software configurations) requires a minimum sample volume of 70 µL. The
ABL80 FLEX CO-OX analyzer with CO-OX software configuration requires a
minimum sample volume of 105 µL. The ABL80 FLEX CO-OX analyzer with
OSM software configuration requires a minimum sample volume of 65 µL.

Animal blood Animal blood has not been tested using the ABL80 FLEX analyzers. Some
components in animal blood differ from those in human blood. Variations in the
composition of blood from different animal species may also exist.

Measured The following parameters can be measured in blood:

parameters,
Parameter Description ABL80 FLEX
ABL80 FLEX Symbol
Configuration
analyzer
FLEX BASIC
pH Acidity or alkalinity X X
pCO2 Carbon dioxide tension X X
pO2 Oxygen tension X X
cCa2+ Calcium ion concentration X X
cK+ Potassium ion concentration X X
cNa+ Sodium ion concentration X X
cCl– Chloride ion concentration. X X
cGlu Glucose concentration (D- X
glucose)
cLac Lactate concentration (L-lactate) X
Hct Volume fraction of erythrocytes X X
in blood (hematocrit)

1-2
ABL80 FLEX Operator's Manual 1. Introduction

Measured The following parameters can be measured in blood:

parameters, Parameter Description ABL80 FLEX CO-OX
ABL80 FLEX Symbol
Configuration
CO-OX
analyzer CO-OX OSM
pH Acidity or alkalinity X
pCO2 Carbon dioxide tension X
pO2 Oxygen tension X
2+
cCa Calcium ion concentration X
+
cK Potassium ion concentration X
+
cNa Sodium ion concentration X
cCl– Chloride ion concentration. X
cGlu Glucose concentration (D- X
glucose)
ctHb Concentration of total X X
hemoglobin
sO2 Oxygen saturation X X
FO2Hb Fraction of oxygenated X X
hemoglobin in total hemoglobin
FCOHb Fraction of carboxyhemoglobin X X
in total hemoglobin
FMetHb Fraction of methemoglobin in X X
total hemoglobin
FHHb Fraction of deoxyhemoglobin in X X
total hemoglobin

1-3
1. Introduction ABL80 FLEX Operator's Manual

Derived The following parameters are derived:

parameters,
Parameter Description ABL80 FLEX
ABL80 FLEX Symbol
Configuration
analyzer
FLEX BASIC
–
cHCO3 (P) Concentration of hydrogen X X
carbonate ion (bicarbonate) in
plasma
cBase(B) Concentration of actual X X
titratable base in blood (actual
base excess)
cBase(Ecf) Concentration of standard X X
titratable base in blood (standard
base excess)
cBase(B,ox) Concentration of actual X X
titratable base in fully
oxygenated blood
cBase(Ecf,ox) Concentration of standard X X
titratable base in fully
oxygenated blood
ctCO2(B) Concentration of total carbon X X
dioxide in blood (CO2 content)
ctCO2(P) Concentration of total carbon X X
dioxide in plasma (CO2 content)
cHCO3–(P,st) Concentration of hydrogen X X
carbonate ion (bicarbonate) in
plasma of standardized blood
(standard bicarbonate)
ctHb Concentration of total X X
hemoglobin in blood
cCa2+(7.4) Concentration of ionized X X
calcium in plasma at a pH of
7.40
Anion Gap Concentration difference X X
(K+) between (K+ + Na+) and (Cl– +
HCO3–)
Anion Gap Concentration difference X X
between Na+ and (Cl– + HCO3–)

1-4
ABL80 FLEX Operator's Manual 1. Introduction

Parameter Description ABL80 FLEX

Symbol
Configuration
FLEX BASIC
ctO2 Concentration of total oxygen in X X
blood (O2 content)
sO2 Oxygen saturation of X X
hemoglobin in blood. It is the
ratio between the concentration
of O2Hb and HHb + O2Hb. The
sum does not include
dyshemoglobins like COHb and
MetHb. Sometimes named
“functional saturation”.
pO2(A) Oxygen tension in alveolar air X X
pO2(A-a) Alveolo-arterial oxygen tension X X
difference
pO2(a/A) Arterio-alveolar oxygen tension X X
ratio
R/I Respiratory index; the ratio X X
between the oxygen tension
difference of alveolar air and
arterial blood and the oxygen
tension of arterial blood
pH (T) pH at patient temperature X X
pCO2 (T) Carbon dioxide tension in blood X X
at patient temperature
pO2 (T) Oxygen tension in blood at X X
patient temperature
pO2(A, T) Oxygen tension in alveolar air at X X
patient temperature
pO2(A-a, T) Alveolo-arterial oxygen tension X X
difference at patient temperature
pO2(a/A, T) Arterio-alveolar oxygen tension X X
ratio at patient temperature
R/I (T) Respiratory index at patient X X
temperature
mOsm Osmolality X

1-5
1. Introduction ABL80 FLEX Operator's Manual

Derived The following parameters are derived:

parameters, Parameter Description ABL80 FLEX CO-OX
ABL80 FLEX Symbol
Configuration
CO-OX
analyzer CO-OX OSM
cHCO3–(P) Concentration of hydrogen X
carbonate ion (bicarbonate) in
plasma
cBase(B) Concentration of actual X
titratable base in blood (actual
base excess)
cBase(Ecf) Concentration of standard X
titratable base in blood
(standard base excess)
cBase(B,ox) Concentration of actual X
titratable base in fully
oxygenated blood
cBase(Ecf,ox) Concentration of standard X
titratable base in fully
oxygenated blood
ctCO2(B) Concentration of total carbon X
dioxide in blood (CO2 content)
ctCO2(P) Concentration of total carbon X
dioxide in plasma
(CO2 content)
cHCO3–(P,st) Concentration of hydrogen X
carbonate ion (bicarbonate) in
plasma of standardized blood
(standard bicarbonate)
cCa2+(7.4) Concentration of ionized X
calcium in plasma at a pH of
7.40
Anion Gap (K+) Concentration difference X
between (K+ + Na+) and (Cl– +
HCO3–)
Anion Gap Concentration difference X
between Na+ and (Cl– + HCO3–)

1-6
ABL80 FLEX Operator's Manual 1. Introduction

Parameter Description ABL80 FLEX CO-OX

Symbol
Configuration
CO-OX OSM
ctO2 Concentration of total oxygen X X
in blood (O2 content)
pO2(A) Oxygen tension in alveolar air X
pO2(A-a) Alveolo-arterial oxygen tension X
difference
pO2(a/A) Arterio-alveolar oxygen tension X
ratio
R/I Respiratory index; the ratio X
between the oxygen tension
difference of alveolar air and
arterial blood and the oxygen
tension of arterial blood
pH (T) pH at patient temperature X
pCO2 (T) Carbon dioxide tension in X
blood at patient temperature
pO2 (T) Oxygen tension in blood at X
patient temperature
pO2(A, T) Oxygen tension in alveolar air X
at patient temperature
pO2(A-a, T) Alveolo-arterial oxygen tension X
difference at patient
temperature
pO2(a/A, T) Arterio-alveolar oxygen tension X
ratio at patient temperature
R/I (T) Respiratory index at patient X
temperature
mOsm Osmolality X
Hct Volume fraction of X X
erythrocytes in blood
(hematocrit)

1-7
1. Introduction ABL80 FLEX Operator's Manual

Parameter Description ABL80 FLEX CO-OX

Symbol
Configuration
CO-OX OSM
P50 Partial pressure of oxygen at X
which the blood is 50%
saturated
P50(T) Partial pressure of oxygen, at X
patient temperature, at which
the blood is 50% saturated
p50(st) Partial pressure of oxygen at X
which the blood is 50%
saturated at standard conditions
pO2(a)/FO2(I) Partial pressure of oxygen as a X
ratio of the fraction of inspired
oxygen
pO2(a,T)/FO2(I) Partial pressure of oxygen, at X
patient temperature, as a ratio
of the fraction of inspired
oxygen
pO2(x) Partial pressure of the oxygen X
extraction of arterial blood
pO2(x,T) Partial pressure of the oxygen X
extraction of arterial blood, at
patient temperature
BO2 Hemoglobin oxygen capacity; X X
the maximum concentration of
oxygen bound to hemoglobin in
saturated blood, such that all
deoxyhemoglobin is converted
to oxyhemoglobin
· Oxygen delivery; the total X
D O2
amount of oxygen delivered to
the whole organism per unit of
time

1-8
ABL80 FLEX Operator's Manual 1. Introduction

Parameter Description ABL80 FLEX CO-OX

Symbol
Configuration
CO-OX OSM
· Cardiac output; the volume of X
Qt
blood delivered from the left
ventricle into the aorta per unit
of time
· Oxygen consumption; the total X
VO2
amount of oxygen utilized by
the whole organism per unit of
time
FShunt Physiological shunt; the ratio of X
the blood shunted from the
right side of the heart to the left
side of the heart without
increasing oxygen content to
the total cardiac output
FShunt(T) Physiological shunt, at patient X
temperature; the ratio of the
blood shunted from the right
side of the heart to the left side
of the heart without increasing
oxygen content to the total
cardiac output
Qx Cardiac oxygen compensation X
factor of arterial blood; 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)
V(B) Volume of blood calculated X X
when FCOHb and V(CO)
values are entered

1-9
1. Introduction ABL80 FLEX Operator's Manual

Known interfering substances

Introduction This topic outlines the substances that are known to interfere with measurements
on human blood on ABL80 FLEX analyzers. The possible sources of these
substances are also described in the table below.
Substance Source Interference
Anions: Br-, I-, S2- Chemotherapies Erroneously high cCl- results
and ClO4-
Anticoagulants Samples Anticoagulants / preservatives which
contain Na+ salts will give erroneously
high cNa+ results
Sodium fluoride (NaF) with or without
EDTA and oxalate (diNa) influence
cNa+, cCa2+ and cCl–
Heparin-benzalkonium, a clot-resistant
coating used on some catheters, may
give erroneously high values for cNa+,
cK+, and cCa2+ results
Radiometer recommends the exclusive
use of balanced heparin as anticoagulant
when performing electrolyte
measurements

NOTE: For a complete list of interfering substances, please see the ABL80 FLEX
reference manual, Chapter 6.

1-10
ABL80 FLEX Operator's Manual 1. Introduction

Warnings and cautions

Introduction For safe and efficient operation of your ABL80 FLEX analyzer the documentation
contains various WARNINGS or CAUTIONS that are important and should be
read carefully before performing the related procedures.
The manual also contains a number of NOTES.

Definition The following table indicates the type of information given in warnings, cautions
and notes ( ! ).
Notice Definition
WARNING Alerts the user to potential serious outcomes to themselves or the
patient such as
• Death
• Injury
• Serious adverse events.
CAUTION Alerts the user to exercise special care necessary for the safe and
effective use of the device.
• Cautions may include actions to be taken to avoid effects on
patients or users that may not be potentially life threatening or
result in serious injury, but about which the user should be
aware.
• Cautions may also alert the user to adverse effects on the
device of use or misuse and the care necessary to avoid such
effects.
NOTE Gives practical information.

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1. Introduction ABL80 FLEX Operator's Manual

Limitations of use
WARNING: The validity of the test results from this instrument must be carefully examined by a
clinician and related to the patient's clinical condition, before any clinical decision
is taken on the basis of the test results.

CAUTION: To prevent possible electric shock to a patient, the user should never touch
conductive connections and a patient at the same time.

CAUTION: Position the analyzer such that the ventilation fans at the rear of the analyzer are
not blocked. Ventilation fans are marked with the symbol. See diagram below.

CAUTION: Ensure the analyzer is positioned such that the power cord can be easily connected
or disconnected.

NOTE: To maintain EMC compliance, use shielded cables for the Ethernet and
Communications ports.

NOTE: No user serviceable parts. All maintenance and repair must be performed by
trained Radiometer personnel. Contact your Service Representative.

Figure 1 – Fan locations at rear of analyzer

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 2. What is what

Introduction All ABL80 FLEX analyzer versions consist of the analyzer, a multi-use,
disposable sensor cassette and a solution pack. Each component is described in
this chapter.

In this chapter This chapter covers the following topics:

Analyzer front view – ABL80 FLEX analyzer ......................................2-2
Analyzer front view – ABL80 FLEX CO-OX analyzer ........................2-3
Analyzer rear view .................................................................................2-4
Solution pack .........................................................................................2-5
Sensor cassette front and rear views ......................................................2-8
Analyzer power ....................................................................................2-13
Installing consumables .........................................................................2-15
2. What is what ABL80 FLEX Operator's Manual

Analyzer front view – ABL80 FLEX analyzer

Introduction This topic identifies the basic parts located on the front of the ABL80 FLEX
analyzer.

Front view

Parts and The table below describes the functions of each part indicated above.
functions
Item Part Function
1 Touch screen Communication interface between the operator and
the analyzer
2 CD drive Read/write CD drive
3 Cassette nest Recessed area to accommodate the sensor cassette
4 Solution pack Holds the solution pack securely in place and
door and latch provides a mechanism to assist in loading and
unloading the solution pack
5 Solution pack To accommodate the solution pack
cavity
6 Roller wheel A bi-directional pump that draws samples into the
cassette measuring chamber and flushes internal
solutions through the same cassette measuring
chamber
7 Barcode scanner Built-in scanner to read barcodes
8 Handle For carrying the analyzer

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ABL80 FLEX Operator's Manual 2. What is what

Analyzer front view – ABL80 FLEX CO-OX analyzer

Introduction This topic identifies the basic parts located on the front of the ABL80 FLEX CO-
OX analyzer.

Front view

Parts and The table below describes the functions of each part indicated above.
functions
Item Part Function
1 Touch screen Communication interface between the operator and
the analyzer
2 CD drive Read/write CD drive
3 Cassette nest Recessed area to accommodate the sensor cassette
4 Solution pack Holds the solution pack securely in place and
door and latch provides a mechanism to assist in loading and
unloading the solution pack
5 Solution pack To accommodate the solution pack
cavity
6 Barcode scanner Built-in scanner to read barcodes
7 Handle For carrying the analyzer

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2. What is what ABL80 FLEX Operator's Manual

Analyzer rear view

Introduction This topic identifies the basic parts located on the rear of all ABL80 FLEX
analyzer versions.

Rear view

Parts and The table below describes the functions of the parts indicated above.
functions Item Part Function
1 Printer Thermal printer with “clamshell” cover
2 PS2 connection For mouse connection
3 PS2 connection For external barcode scanner or
keyboard connection
4 Video connection Video output to an external monitor
5 Power switch For turning the analyzer on. Never use
this button to turn off the analyzer;
always use the Shutdown button on the
main menu. Using this switch to turn
off the analyzer may corrupt data files.
6 Power cord socket For connecting the power cord
7 RS232 serial COMM For unidirectional communication from
port the ABL80 FLEX analyzer
8 USB Two ports for connection to a variety
of external devices
9 RJ45 Ethernet network Ethernet interface connection
port

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ABL80 FLEX Operator's Manual 2. What is what

Solution pack
Introduction Quality management of the system is accomplished using a solution pack that
contains multiple levels of precision tonometered electrolyte solutions packaged in
gas tight disposable pouches. The solution pack provides the necessary fluids for
the calibration and quality control of all measured parameters.
Each solution pack contains a smart chip that provides information to the system
regarding the status of the solution pack. The analyzer automatically reads this
information when the solution pack is installed onto the analyzer and writes
additional information to the smart chip during use. This information includes the
following:
• Serial number of the pack
• Lot number for each of four solution pouches
• Install by date (the last day this solution pack can be installed onto an analyzer)
• Installation date (the date this solution pack was installed onto an analyzer)
• Analyzer serial number (the analyzer onto which this pack was installed)
• Number of allowable days in use
• True (calibration) values for each parameter
• Quality control assigned values and acceptable ranges for each parameter (not
included in solution packs for the ABL80 FLEX analyzer with BASIC software
configuration)
• Number of cycles for each pouch
• Version

SP types There are five solution pack designs, each with a unique part number:
• SP80 is for use in the ABL80 FLEX analyzer with the FLEX software
configuration (REF 944-174)
• A second configuration of the SP80 is for use in the ABL80 FLEX analyzer
with the BASIC software configuration (REF 944-309)
• A third configuration of the SP80 is for use in the ABL80 FLEX analyzer with
the BASIC software configuration, supporting lactate measurement
(REF 944-383)
• SP80 CO-OX is used in the ABL80 FLEX CO-OX analyzer (REF 944-252)
• A second configuration of the SP80 CO-OX is for use in the ABL80 FLEX CO-
OX analyzer with the OSM software configuration (REF 944-341)

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2. What is what ABL80 FLEX Operator's Manual

Pouches The solution pack contains five pouches:

• Four pouches contain NIST traceable solutions with various concentrations of
tonometered gases, electrolytes and metabolites
• Dyes are included in the SP80 CO-OX for use in the oximeter
• Only dyes are included in the SP80 CO-OX for use with the OSM software
configuration. There are no tonometered gases, electrolytes or metabolites
included.
• The fifth pouch collects all liquid waste, both from the internal solutions and all
external solutions including the biohazardous bodily fluids from patient
samples. The waste pouch contains an additive, which combines with the liquid
waste to form a gel. This gel limits spillage and provides an added level of
safety.

WARNING: After use, the solution pack may contain material that is a biohazard. Avoid
contact with the waste inlet port. Clean any spillage and dispose of cleaning
materials and the solution pack in the accepted manner per institutional
biohazardous waste disposal guidelines.

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ABL80 FLEX Operator's Manual 2. What is what

Figures Solution pack

Front view Rear view

Internal view

Parts and The solution pack contains the following components:

functions
Item Part Function
1 Install by date The last day the solution pack can be installed
2 Lot number The lot number of the solution pack
3 Smart chip Provides and records specific information
pertaining to the solution pack
4 Solution ports Access ports for the pouch solutions for use in
the analyzer
5 Waste port Entry point of waste fluids into waste pouch
6 Solution pouches Contain NIST traceable solutions; each pouch
contains a unique lot of solutions
7 Waste pouch Contains all waste fluids

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2. What is what ABL80 FLEX Operator's Manual

Sensor cassette front and rear views

Introduction The sensor cassette is designed for use with whole blood or quality control
solutions. The sensor cassette contains a low volume, flow-through cell. All the
measuring sensors for pH, blood gas, electrolytes and glucose are contained in a
multi-use disposable cassette assembly. The cassette flowcell also contains a
reference electrode for the potentiometric sensors and an integral temperature
sensor and heating element for precise temperature control.
Each sensor cassette contains a smart chip that provides information to the system
regarding the type and status of each sensor cassette. The analyzer automatically
reads this information when the cassette is installed onto the analyzer. While in-
use the analyzer also records additional information on the smart chip. Information
recorded in the smart chip includes:
• Lot number
• Serial number
• Parameter panel
• Number of tests allowed
• Number of tests remaining
• Compatible analyzer configuration (the type of analyzer that the sensor cassette
can be installed on)
• Install by date (the last day this sensor cassette can be installed onto an
analyzer)
• Installation date (the date this cassette was first installed onto an analyzer)
• Analyzer serial number (the analyzer onto which this cassette is currently
installed)
• Expiration date (date this sensor cassette will expire once installed)

SC types There are two sensor cassette designs, SC80 and SC80 CO-OX:
• One group of SC80 sensor cassettes is for use in the ABL80 FLEX analyzer
with the FLEX software configuration
• A second group of SC80 sensor cassettes is for use in the ABL80 FLEX
analyzer with the BASIC software configuration
• SC80 CO-OX sensor cassettes are for use in the ABL80 FLEX CO-OX analyzer
• A second type of SC80 CO-OX sensor cassette is specifically designed for use
in the ABL80 FLEX CO-OX analyzer with the OSM software configuration.
This version does not include a sensor window.

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ABL80 FLEX Operator's Manual 2. What is what

Front view –
SC80

Parts and The table below describes the function of the parts above.
functions –
SC80
Item Part Function
1 Sensor window Allows viewing of the measuring chamber. All
measuring sensors are located here.
2 Inlet flap For positioning the inlet probe. The lower (45°)
position is for syringe samples and QC ampoule
introduction. The upper (90°) position is for
capillary sample introduction.
3 Inlet probe For introducing all samples into the measuring
chamber
4 Release latch For disengaging and removing the cassette
5 Peristaltic pump Transport path for all solutions to and from the
tubing measuring chamber

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2. What is what ABL80 FLEX Operator's Manual

Top view –
SC80

Rear view –
SC80

Parts and The table below describes the functions of the parts indicated above.
functions –
SC80
Item Part Function
1 Serial number Provides sensor cassette serial number
label
2 Sensor Provides the electronic connection between
connection pins the sensor cassette and the analyzer
3 Connection For guiding the sensor cassette onto the
guide analyzer
4 Fluid port Transport path for fluids
5 Release latch For disengaging and removing the cassette
6 Lot number Displays the lot number of the sensor
cassette
7 Inlet flap For positioning the inlet probe
8 Install by date Displays the final day the sensor cassette
can be installed

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 ABL80 FLEX Operator's Manual 2. What is what

Front view –
SC80 CO-OX

Parts and The table below describes the function of the parts above.
functions –
SC80 CO-OX
Item Part Function
1 Sensor window Allows viewing of the measuring chamber. All
measuring sensors are located here. Cassettes
compatible with the OSM software do not include
a sensor window.
2 Inlet probe For introducing all samples into the measuring
chamber
3 Inlet handle For raising the inlet probe to either a 45° angle for
syringe and ampoule samples or to a 90° angle for
capillary tube samples. Also controls the
automatic wiping mechanism that cleans the outer
surface of the inlet probe.
4 Guide Guides the placement of the sample
5 Release latch For disengaging and removing the cassette

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2. What is what ABL80 FLEX Operator's Manual

Top view –
SC80 CO-OX

Rear view –
SC80 CO-OX

Parts and The table below describes the functions of the parts indicated above.
functions –
SC80 CO-OX
Item Part Function
1 Serial number Provides sensor cassette serial number
label
2 Sensor Provides the electronic connection between
connection pins the sensor cassette and the analyzer
3 Connection For guiding the sensor cassette onto the
guide analyzer
4 Fluid ports Transport path for fluids
5 Release latch For disengaging and removing the cassette
6 Lot number Displays the lot number of the sensor
cassette
7 Install by date Displays the final day the sensor cassette
can be installed
8 Inlet handle For raising and lowering the inlet probe
9 Guide Guides the placement of the sample

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ABL80 FLEX Operator's Manual 2. What is what

Analyzer power
Power up the Follow the steps below to turn on all versions of the analyzer.
analyzer
NOTE: The analyzer will not boot up properly if a USB memory stick is connected
to either USB port at the rear of the analyzer. Remove any USB memory stick
prior to powering up the analyzer.

Step Action
1. Insert the power cord into the
power cord socket, labeled

at the rear of the analyzer.

2. Connect the three-pronged power cord to an AC source.

3.
Press and hold the upper half of the power switch, labeled at
the rear of the analyzer for at least three seconds. An audible
click along with a flickering light from the analyzer display
signifies the power has been turned on.
4. Release the power switch and allow the analyzer operating
system and application software to load. This process will take
approximately three minutes.

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2. What is what ABL80 FLEX Operator's Manual

Powering down Follow the steps below to turn off all versions of the analyzer.
the analyzer
Step Action
1. From the main menu, press Menu then select Shutdown.

2. The system will bring up a question box to verify your intent to

power down the analyzer.
• Press Yes to continue with the shutdown procedure
• Press No to cancel and return to the main menu
CAUTION: It is very important that the analyzer always be
powered down through the software application. Pressing the
power on/off switch at the back of the analyzer while the
application is running can result in file corruption.

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ABL80 FLEX Operator's Manual 2. What is what

Installing consumables
Introduction All versions of the ABL80 FLEX analyzer system contain three consumable items.
They are printer paper, a solution pack and a sensor cassette.
Print queue The analyzer has a print queue that will store up to six print jobs. If the printer is
not able to print for any reason (e.g. out of paper) it will store only the last six
print jobs. Once able to print, the printer will automatically print all jobs in the
print queue.
Printer paper When the paper roll is near the end, a red stripe will appear on the paper edge.
Always replace the paper roll when the red stripe appears to ensure successful
printout of results.
Follow the steps below to load/replace the printer paper.
Step Action
1. Press the release latch (see arrow)
to disengage the printer cover.

2. Slide the clam-shell cover back to

expose the paper roll
compartment.

3. Remove any existing roll of paper, as necessary.

4. Lay a new roll of paper inside the
compartment, with the free end of
the paper coming forward off the
roll from the bottom. Ensure the
free end of the paper extends
beyond the lip of the printer cover.
5. Slide the clam-shell cover forward and press down on the cover over
the raised lines (see arrow). Installation is complete when the cover
snaps into place, securing the paper.

Solution pack Please refer to Chapter 8, Install for instructions on the installation of the ABL80
and sensor FLEX solution pack and sensor cassette.
cassette

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2. What is what ABL80 FLEX Operator's Manual

2-16
 3. General software features

Introduction Operation and management of all ABL80 FLEX analyzer versions is performed via
the touch screen user interface. This chapter describes the screen and menu
structure as well as the function of various buttons and icons.

In this chapter This chapter covers the following topics:

Touch screen ..........................................................................................3-2
Main menu .............................................................................................3-3
Analyzer status .......................................................................................3-5
Tutorials .................................................................................................3-8
Failure report ........................................................................................3-10
Icons .....................................................................................................3-13
3. General software features ABL80 FLEX Operator's Manual

Touch screen
Introduction The display screen for all ABL80 FLEX analyzer versions is an 800 × 600 color
LCD with a resistive touch panel overlay for menu and feature activation. Pressing
an icon, text or button will activate the requested option or provide sub-menu
selections.

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ABL80 FLEX Operator's Manual 3. General software features

Main menu
Description The main menu consists of several sections.
The top section of the screen consists of the title bar area. It displays the status of
the analyzer to the user and provides access to additional information, including:
• Status message
• System status traffic light
• Data Logs button
• Parameter bar
• The center section of the screen can display the following elements:
• User logged onto the system
• Quick keys (only appear when quick keys are enabled)
• Analyzer message (only appears when a message is entered)
• The bottom section of the screen can display the following elements:
• Menu button
• Logoff button (appears only when a user is logged onto the system)
• Tutorials button
• Enter Standby button (only on the ABL80 FLEX analyzer with BASIC software
configuration and the ABL80 FLEX CO-OX analyzer with OSM software
configuration)
• RADIANCE/AQURE communication status (only appears when
RADIANCE/AQURE communication is enabled)
• Power status (AC or battery)
• Time of day

Screen The following is an example of the main menu.

Title bar with system status

Center section

Menu bar

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3. General software features ABL80 FLEX Operator's Manual

Touch keys The table below describes the functions of touch keys in the main menu.
Touch key Function
System status traffic Provides a color-coded indicator and message to the user
light of the current status of the analyzer with regard to sample
analysis availability. Press the icon to display all related
system messages. Press Close or the Menu button to close
this window.
Data Logs Provides quick access to the data logs stored in the
analyzer. All patient samples, calibrations and quality
control results, as well as other stored information, can be
accessed by pressing this icon.
Menu Provides access to all available navigation menu options.
The options available depend on the security settings
established in the system.
Logoff Appears only when a user is logged onto the analyzer. It
provides the ability to manually log the user off the
system.
Tutorials Provides instructional video, text and audio for a variety
of basic user operations.
Enter Standby Allows the user to manually enter the Standby mode. This
feature is only available in the ABL80 FLEX analyzer
with BASIC software configuration and the ABL80
FLEX CO-OX analyzer with OSM software
configuration.

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ABL80 FLEX Operator's Manual 3. General software features

Analyzer status
Introduction Analyzer activity status is continuously displayed in the main menu using a system
status traffic light and a verbal description in the upper left corner of the screen.

System status The system status traffic light continuously communicates the readiness of the
analyzer to perform sample analysis. The number of tests remaining on the
currently installed sensor cassette is also displayed as part of the system status
information.
The system status traffic light icon displays one of three conditions:
(Green light): the analyzer is ready for sample analysis

(Yellow light): the analyzer is ready for sample analysis but there are
one or more conditions soon to occur which will cause the sample
analysis feature to be unavailable
(Red light): sample analysis is unavailable due to one or more analyzer
conditions

To view details of the analyzer status for sample analysis, the user can touch the
traffic light icon to bring up a System Status screen with detailed messages.
The conditions monitored by the analyzer in System Status include:
• Sensor cassette installation status
• Solution pack installation status
• The number of tests remaining and expiration date of the currently installed
sensor cassette
• The number of cycles remaining and expiration date of the currently installed
solution pack
• System Cycle (or 2-point Cal) status
• The time before manual QC is due to be performed
• Manual QC results (in combination with the QC Lockout feature)
• Manual QC lot expiration dates
• Analyzer lockout settings
• Number of open records remaining
• Time before data maintenance is due
• Time before tHb calibration is due (ABL80 FLEX CO-OX analyzer only)
The limiting value (threshold) for most conditions may be defined by the user.
These values will determine when the System Status condition changes from
Green to Yellow (warning). Red conditions are predefined as any condition that
disables analysis such as 0 tests remaining on a sensor cassette or a failed
calibration. See Chapter 9, Settings for information on setting the threshold values.

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3. General software features ABL80 FLEX Operator's Manual

Parameter bar The parameter bar, displayed on the main menu, lists the parameters available for
reporting by the analyzer. There is a separate display for each parameter. The
system displays each parameter in one of three colors to indicate its status.
• Green – the parameter is active, functioning properly and available for sample
analysis
• Yellow – the parameter is active, but at least one manual QC measurement
result fell outside the acceptable range and QC Warning is enabled (see
Chapter 9, Settings). Exercise caution when using results from this parameter
• Red – the parameter failed the last System Cycle (or 2-point cal), the parameter
was inactivated or locked out for the current cassette, or a manual QC lockout
condition exists.
A parameter that is not installed or inactivated for all cassettes will not appear in
the parameter bar.

Status bar The following table lists possible messages that the analyzer may display in the
messages status bar (upper left corner of the main menu screen) while performing various
functions.
Message Description
Ready: xxx of yyy tests The analyzer is ready for sample analysis. It also
remaining lists the number of tests that are remaining on the
currently installed sensor cassette.
Rinsing... The system is rinsing solution through the sensor
cassette
Analysis disabled The analyzer is not available for sample analysis
Shutting down... When Shutdown is selected from the Menu, the
analyzer will close the application through a
controlled shutdown procedure

System In addition to the information available on the main menu, the analyzer will display
information a number of system information tabs describing the status of the analyzer. This
information can be found under Data  System Information. The following
categories are included: General, Solution Pack, Sensor Cassette, Manual QC
Schedule and Data Communications.
• General: This general information will include the analyzer serial number,
analyzer name, software version, a list of active parameters, last and next system
cycle (or 2-point Cal), last system check (as applicable) and other software and
firmware information. A print icon is available to print this information.
• Solution Pack: Information about the currently installed solution pack will
include the installation and expiration dates, lot and serial number of the pack,
the lots of each individual solution pouch and remaining cycles, the calibration
values in each pouch, and the quality control values (assigned value and
acceptable range) for each pouch (quality control values are not included in
solution packs for use with the ABL80 FLEX analyzer with BASIC software
configuration). A print icon is available to print this information.
• Sensor Cassette: Information about the currently installed sensor cassette will
include the install and expiration dates, number of tests allowed, number of tests

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ABL80 FLEX Operator's Manual 3. General software features

remaining, the lot, serial number and model of the SC. A button is provided to
direct the user to the most current System Cycle or 2-point Cal record for this
sensor cassette. A print icon is available to print this information.
• Manual QC Schedule: When a schedule is defined under the Settings 
Manual QC  Schedule screen, the pending manual QC measurements will be
listed on this tab. If no schedule is defined, this tab will not appear.
• Data Communications: When a connection type is specified in the Data
Communications screen, the connection status and number of records left to
synchronize, is displayed. If no connection type is specified, this tab will not
appear.

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3. General software features ABL80 FLEX Operator's Manual

Tutorials
Introduction All ABL80 FLEX analyzer versions provide instructions to the user for a variety of
commonly performed procedures. The instructions are presented in a video tutorial
format which includes video clips with accompanying descriptive text and audio.

Tutorial topics The video tutorials include the following topics:

• Sample analysis using a syringe sample
• Sample analysis using a capillary sample
• Installation of a sensor cassette
• Installation of a solution pack
• Installation of a roll of paper

General use Perform the following general instructions when reviewing tutorial information.
Step Action
1. From the main menu select
Tutorials.

2. Select the desired tutorial from the playlist provided. The tutorial may
be highlighted by either touching the tutorial title directly or using the
up and down arrow buttons.
3. Press Play to begin the selected tutorial.

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ABL80 FLEX Operator's Manual 3. General software features

4. A divided screen will appear. Video information will be displayed on

the left and descriptive text will be displayed on the right.

5. The following buttons are used to control the play function of the
video tutorials:

Icon Function Icon Function

Play Pause

Stop

Audio on Muted

Increase volume Decrease volume

Go back to the previous Advance to the next section

section

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3. General software features ABL80 FLEX Operator's Manual

Failure report
Introduction The Failure Report screen allows the user to easily locate failed event records
(calibration or quality control) for consumables (sensor cassettes and solution
packs) replaced in the last three months. These records can then be downloaded to
a USB drive.
This downloaded file can be used to report to your Radiometer representative when
a consumable required premature replacement due to performance issues.
Description The Failure Report screen is divided into two tabs:
• Failure Events – provides a list of all unique combinations of sensor cassettes
and solution packs associated with failed events.
• Contact Information – information added to each failure event download file
identifying the customer. Users are encouraged to complete all fields to ensure
proper identification. These fields only need to be completed once; the contact
information will be retained for all subsequent failure events.

Downloading a Follow the steps below to download a failed event.

Failed event
Step Action
1. From the main menu, select Menu  Data  Failure report.

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ABL80 FLEX Operator's Manual 3. General software features

2. On the Failure Events tab scroll through the list of events and
highlight the event of interest. The most recent event is at the top of
the screen.
The information on this screen includes:
• Analysis Time – the time of the event
• SC Lot – the lot number of the sensor cassette in use at the time of
the failed event
• SC s/n – the serial number of the sensor cassette in use at the time
of the failed event
• SP s/n – the combination of the lot number (first six digits) and
unique identifying numbers (last three digits) which, when
combined, defines the serial number of the solution pack in use at
the time of the failed event
• Event – the type of event that failed such as “System Cycle”, “2
Point Cal” or “Manual QC”
• Status – the overall status of the failed event. This column will list
the parameter(s) that failed during the event or other failure status
types such as a temperature error.
3. Option Steps
To review the highlighted failed
Press the Preview button.
event.
To generate a printout of the
Press the Print button.
highlighted event.
Connect a USB drive to either
USB port at the rear of the
analyzer and then press Export.
To download the failed event NOTE: The system will display
record. the message, “File export
complete” when the failed event
is successfully exported to the
USB drive.
4. Press Close.

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3. General software features ABL80 FLEX Operator's Manual

Entering Follow the steps below to enter information in the Contact information fields.
Contact
information 1. Press the keyboard button next to each field and enter the appropriate
information.

NOTE: Please note that the field “Institution Name” is a mandatory field.

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ABL80 FLEX Operator's Manual 3. General software features

Icons
Navigation tree The structure of the navigation tree, along with the menu icons and a functional
with icons description, is presented below. All analyzer versions contain the icons below,
unless otherwise noted.
Icon Function Icon Function
Analysis
To perform a sample
analysis
Manual QC
To perform a manual QC
analysis
Manual System Cycle (or
Manual 2 Point Cal)
To initiate a System Cycle
or 2-point calibration

Data

Logs 
Patient logs
To review database records

Manual QC logs

System Cycle logs (not available

with the BASIC configuration of
the ABL80 FLEX analyzer)

2 Point Cal logs

tHb Calibration logs (ABL80

FLEX CO-OX analyzer only)
SC Check (ABL80 FLEX CO-
OX analyzer with OSM software
configuration only)

Event logs

Security logs

Upload 
To upload records to an Patient upload
external database

Manual QC upload

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3. General software features ABL80 FLEX Operator's Manual

Icon Function Icon Function

System Cycle upload (not
available with the BASIC
configuration of the ABL80
FLEX analyzer)

2 Point Cal upload

tHb Calibration upload

(ABL80 FLEX CO-OX
analyzer only)
WDC upload (QA Portal must
be enabled)
Download 
To export records to an Patient download
external storage device

Manual QC download

System Cycle download (not

available with the BASIC
configuration of the ABL80
FLEX analyzer)

2 Point Cal download

tHb Calibration download

(ABL80 FLEX CO-OX analyzer
only)
System Check download (not
available with the BASIC
configuration of the ABL80
FLEX analyzer)
SC Check download (ABL80
FLEX CO-OX analyzer with
OSM software configuration
only)

Events download

Security download

WDC download

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ABL80 FLEX Operator's Manual 3. General software features

Icon Function Icon Function

Maintenance 
To perform or schedule Initiate Data Maintenance
database maintenance

Schedule Data Maintenance

System Information
To review basic
information about the
analyzer
Failure Report
To locate and download a
system error report for a
sensor cassette or solution
pack

Utilities

Install 
Install SC80
To install consumables

Install Solution Pack

Counter
To monitor the number of
analyses and other events
Settings Transfer 
To transfer analyzer Transfer To Disk
settings from one analyzer
to another

Transfer From Disk

tHb Calibration
(ABL80 FLEX CO-OX
analyzer only)
Rinse
To initiate a manual rinse
Software Upgrade
To perform a Radiometer
software upgrade
Eject CD
To manually eject a CD
from the internal drive

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3. General software features ABL80 FLEX Operator's Manual

Icon Function Icon Function

Settings

Patient
To establish acceptable
ranges, critical limits and
reportable ranges
Manual QC 
To select various manual Manual QC Ranges
QC settings

Manual QC Lockout

Manual QC Statistical Factor

Manual QC Schedule

Manual QC Temperature

RiliBÄK Ranges (optional)

System Cycle (or 2 Point

Cal)  System Cycle Schedule (or 2
To establish the System Point Cal Schedule
Cycle frequency
System Cycle Drift (not available
with the BASIC configuration of
the ABL80 FLEX analyzer)
Standby Schedule (only with the
BASIC configuration of the
ABL80 FLEX analyzer and the
OSM configuration of the ABL80
FLEX CO-OX analyzer)
tHb Calibration  tHb Schedule
(ABL80 FLEX CO-OX (ABL80 FLEX CO-OX analyzer
analyzer only) only)

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ABL80 FLEX Operator's Manual 3. General software features

Icon Function Icon Function

Setup 
To select from a variety of Date and Time Setup
analyzer setup functions

Units Setup

Data Communications

FlexLink Setup

Analyzer Message

System Status Setup

Correlation Setup

Record Deletion Setup

Main Menu Setup

Reports 
To select from a variety of Input Fields Setup
input and printout options
Printout Setup (software versions
<3.00)

Report Options (software

versions ≥3.00)

Download Patient Setup

System 
To select from a variety of Active Parameters Setup
general analyzer settings
Air Detection Setup (not
available with the OSM
configuration of the ABL80
FLEX CO-OX analyzer)

Analyzer Lockout Setup

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3. General software features ABL80 FLEX Operator's Manual

Icon Function Icon Function

Security
To establish a security
system and manage users
Logon
To log onto the analyzer Logoff
prior to use
Shutdown
To perform a controlled
shutdown of the analyzer
hardware and software
Enter Standby Exit Standby
To manually enter the To manually exit the Standby
Standby mode (only with mode (only with the BASIC
the BASIC configuration of configuration of the ABL80
the ABL80 FLEX analyzer FLEX analyzer or the OSM
or the OSM configuration configuration of the ABL80
of the ABL80 FLEX CO- FLEX CO-OX analyzer)
OX analyzer)

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ABL80 FLEX Operator's Manual 3. General software features

Function icons The function icons are described below.

Icon Function Icon Function

Cancel/Close Upload Results

Back Patient Information

OK Patient Query

Aspirate New layout

Edit Delete layout

Print Add item to report

Print Preview Remove item from report

Set as default Edit Layout

Patient Record Screen preview

Manual QC Record Copy Layout

System Cycle Record (not

available with the BASIC
Add a User or Permission
configuration of the ABL80
FLEX analyzer)
Delete a User or
2 Point Cal Record
Permission

QC Plot results Reset User Expiration

QC Statistics Reset Counter

Parameter Panel Number Entry Key Pad

Scan Barcode Approval

Text Keyboard

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3. General software features ABL80 FLEX Operator's Manual

Navigation and The navigation and other icons are described below.
other icons
Icon Function Icon Function
System Check in
System status – communicates the
progress (not available
analysis status of the analyzer.
with the BASIC
Press this icon to view status
configuration of the
messages.
ABL80 FLEX analyzer)

Warning Instruction / Mandatory

Delete one character Delete all characters

AC power Battery power

RADIANCE/AQURE connection RADIANCE/AQURE

active connection not active

Air detection is not

available (not available
with the OSM
Enter
configuration of the
ABL80 FLEX CO-OX
analyzer)

Move cursor down Move cursor up

Move cursor right by

Move cursor left by one point
one point

Move cursor to the left of the Move cursor to the right

screen of the screen
Change viewing to the
Change viewing to the preceding
next window of data
window of data (QC plot screen)
(QC plot screen)

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 4. Sample measurements

Introduction This chapter describes how to analyze patient blood samples on all versions of the
ABL80 FLEX analyzer and how to manage related information.

In this chapter This chapter covers the following topics:

General information ...............................................................................4-2
Introducing a blood sample ....................................................................4-3
Sample information ..............................................................................4-15
Patient report ........................................................................................4-20
Edit patient information .......................................................................4-21
Patient edit log .....................................................................................4-24
Approval...............................................................................................4-25
FlexLink ...............................................................................................4-27
4. Sample measurement ABL80 FLEX Operator's Manual

General information

Sample size The ABL80 FLEX analyzer aspirates a sample volume of approximately 70 µL for
each measurement. The ABL80 FLEX CO-OX analyzer aspirates a sample volume
of approximately 105 µL for each measurement. The ABL80 FLEX CO-OX
analyzer with OSM software configuration aspirates a sample volume of
approximately 65 µL for each measurement. This volume is automatically
aspirated into the analyzer during the sample analysis procedure.

Sample types Both analyzer versions will accept syringe and capillary tube samples. Syringe
samples (including safePICO samplers with safeTIPCAP) are designed for
aspiration with the sensor cassette inlet probe in the first, lower position. Capillary
tubes are designed for aspiration with the sensor cassette inlet probe in the second,
horizontal position. See Chapter 11, Sampling for more information on sample
acquisition and sampling devices.

Sample mixing It is critical that a sample is thoroughly mixed prior to its introduction into the
with a syringe analyzer. Use of the safePICO sampler with the safePICO Mixer will provide
optimal mixing. When manually mixing the sample, the syringe should be inverted
several times then rolled between the palms of your hands repeatedly for at least
15 seconds just prior to sample aspiration.

Sample mixing Capillary samples can be mixed using a mixing wire and magnet. When using a
with a capillary safeCLINITUBE capillary tube, the mixing wire must be removed PRIOR to
tube sample aspiration.

CAUTION: In general, results obtained from capillary samples, particularly pO2 values,
should be interpreted with caution.
CAUTION: If there is an air bubble in a capillary sample that has been stored, pH and blood
gas values should not be measured.
CAUTION: During measurement observe the sample in the measuring chamber through the
sensor cassette window. If any air bubbles are seen, disregard the results and
repeat the measurement.
NOTE: With the OSM software configuration of the ABL80 FLEX CO-OX analyzer it is
not necessary to observe the sample for air bubbles in the sensor cassette because
sample measurement is not performed within its measuring chamber. For this
reason, a window is not included in the sensor cassette compatible with the OSM
software configuration.

Manual rinse If blood residue is noted inside the measuring chamber following sample
measurement, a manual rinse can be initiated. See Chapter 8, Utilities for
instruction on initiating a rinse.

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ABL80 FLEX Operator's Manual 4. Sample measurement

Introducing a blood sample

Sample analysis Follow the steps below to perform a sample analysis. There are several
procedure configuration options including Parameter Panel, Patient Type, Printouts,
hematocrit correlation and FHb correction. See Chapter 9, Settings for details on
the selection and function of these optional features.

Step Action
1. Ensure the analyzer is ready to accept a patient sample.
• Ready is displayed in the upper left corner of the main menu
• Traffic light is displaying a green or yellow light
• The desired parameters are available (appear in the parameter bar
and are either green or yellow)
2. Select Menu  Analysis
ABL80 FLEX analyzer aspiration screen:

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4. Sample measurement ABL80 FLEX Operator's Manual

2. ABL80 FLEX CO-OX analyzer aspiration screen:

(Cont.)

3. The selection of parameters can be presented in one of two ways on

the screen. The first way, as shown above, is with the Parameter
Panel feature disabled.
In this configuration, each parameter is represented by a single button.
Pressing the button will remove or add a check mark to activate it for
reporting.
• A green outlined button with green check mark indicates this
parameter is functioning properly and is available for reporting
measurement results
• A yellow outlined button with yellow check mark indicates this
parameter has a warning status for prior failed QC. It is, however,
available for reporting measurement results if desired.
• A red outlined button with red check mark indicates this parameter
is not functioning properly and is not available for reporting
measurement results.
• Any inactivated parameters will be displayed as a grayed out button
and non-functional

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ABL80 FLEX Operator's Manual 4. Sample measurement

4. When the Parameter Panel feature is enabled (see Chapter 9, Settings

to enable), the choices for parameters appear as shown here:

The user selects the desired parameter panel by using the drop-down
choices labeled Parameter Panel.
The individual parameters shown communicate which parameters are
available/reported for a given parameter panel.
• All parameters have a gray background, signifying they cannot be
individually selected or de-selected on this screen
• Parameters with a green check mark are active and will be reported
during this sample measurement
• Parameters with a yellow check mark will be reported for this
sample measurement but are in a “yellow” state (e.g. manual QC
warning state for this parameter)
• Parameters with a red border and red check mark have been pre-
defined as part of the selected parameter panel but are inactive and
unavailable for this sample measurement
NOTE: Parameter Panel always includes a Custom Panel selection
which functions in the same manner as the description above when
Parameter Panel is disabled.
NOTE: The user is not allowed to select a parameter panel when
FlexLink is enabled and in use.

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4. Sample measurement ABL80 FLEX Operator's Manual

5. Review the other selections in the Sample Aspiration screen. These

selections can include the following:
• Sample type – selections include arterial, venous, capillary, mixed
venous, proficiency and other
• Patient type – see Chapter 9, Settings to enable
• Printouts – see Chapter 9, Settings to enable
• Apply hemodilution correlation (Hct) – see Chapter 9, Settings to
enable (ABL80 FLEX analyzer only)
• Enable HbF correction – see Chapter 9, Settings to enable (ABL80
FLEX CO-OX analyzer only)
6. Thoroughly mix the blood sample. This step is especially critical for
accurate hematocrit and hemoglobin values.
7. a. For syringe samples: ABL80 FLEX analyzer:
• ABL80 FLEX analyzer -
Raise the inlet probe to the
first position

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ABL80 FLEX Operator's Manual 4. Sample measurement

• ABL80 FLEX CO-OX ABL80 FLEX CO-OX analyzer:

analyzer – slide the handle up
to the first position

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4. Sample measurement ABL80 FLEX Operator's Manual

7a. All analyzer versions: General syringe types:

(Cont.) • Guide the inlet probe into the
sample.
• Ensure the tip of the inlet
probe is fully immersed in the
sample.

safePICO sampler with

safeTIPCAP:

NOTE: Do not press the tip of the inlet probe against the syringe
plunger. This can produce an airtight seal and prevent sample
aspiration.

WARNING: Exercise caution when the inlet probe is raised to prevent inadvertent contact with
the tip.

7. b. For capillary samples in the

ABL80 FLEX analyzer:
(Cont.)
• Raise the inlet probe to the
second position (horizontal)

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ABL80 FLEX Operator's Manual 4. Sample measurement

• Slide the ABL80 FLEX

capillary adapter onto the inlet
probe, advancing it until it
stops at the top of the probe

• Ensure the blood column in

the capillary tube extends to
the end of the tube

7b. • Insert the capillary tube into

the adapter

• Press the tube into the adapter

until a small displacement of
blood is seen inside the
adapter. This displacement
indicates that the probe has
entered the capillary tube,
displacing a small amount of
the blood sample, and ensures
an air-free connection.

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4. Sample measurement ABL80 FLEX Operator's Manual

7. c. For capillary samples in the Step 1:

ABL80 FLEX CO-OX
(Cont.)
analyzer:
• Step 1: Slide the handle up to
the first position

Step 2:

• Step 2: Continue pulling the

handle up and forward to lock
it into the second position for
capillary sampling

• Insert the capillary tube into

the ABL80 FLEX CO-OX
adapter

• Place the capillary tube, with

adapter, onto the analyzer’s
inlet probe

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ABL80 FLEX Operator's Manual 4. Sample measurement

8. On all analyzer versions, press Aspirate.

NOTE: ABL80 FLEX CO-OX analyzer only - The Aspirate button

must be pressed within 20 seconds after raising the inlet probe. If not
pressed within 20 seconds, the analysis will be cancelled.
9. The analyzer will beep twice when aspiration is complete. The screen
will provide instructions on removing the sample and lowering the
inlet flap.

10. To lower the inlet probe, follow the analyzer-specific instruction.

• ABL80 FLEX analyzer – Press down on the inlet flap until the inlet
probe is fully lowered.

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4. Sample measurement ABL80 FLEX Operator's Manual

• ABL80 FLEX CO-OX analyzer: Step 1:

• Step 1: If the inlet probe was in
the capillary position, press
back and down on the handle to
release the inlet probe

Step 2:
• Step 2: Slide the handle down
until it clicks into the fully
lowered position

11. All analyzer versions will automatically display any input fields
enabled. Review these fields and enter any information desired using
the controls provided. See Sample information later in this chapter for
detailed instructions on using this input screen. See Chapter 9, Settings
to enable input fields.
12. When all information is entered, press OK.
13. A progress bar will be displayed until the analysis is complete. During
the second half of sample measurement, preliminary values will be
displayed. These values should be used or interpreted for trending
purposes only.

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ABL80 FLEX Operator's Manual 4. Sample measurement

14. Final results will be displayed on the screen and be available for
printouts.
ABL80 FLEX analyzer results screen:

ABL80 FLEX CO-OX analyzer results screen:

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4. Sample measurement ABL80 FLEX Operator's Manual

15. Final results from all analyzer versions can be flagged with any of the
following markings:
Marking Definition
The final result is outside the reference range but not
or beyond the critical limits. On the screen this result is
also highlighted in yellow.
The final result is beyond the critical limits. On the
or screen this result is also highlighted in red.
The final result is outside the test range of the analyzer.
or On the screen this result is also highlighted in red.
> cGlu or cLac exceeds the linearity range upper limit
based on the measured pO2
R/R or * The final result is outside the user-defined reportable
range. The final result can either be replaced by the
acronym R/R or flagged with an asterisk. See Chapter
9, Settings for details on setting this option.
R/S Results have been suppressed due to a system error
associated with this measurement.
*** The final result is outside the measuring range of the
analyzer.
### The final result is beyond the electrical range of the
analyzer.
!! Possible air was identified in either the sample or the
flush during analysis.
? One or more errors have been identified related to
oximetry results. All related results are flagged with a
question mark. Use results with caution.
¿ The last manual QC sample run on this parameter was
outside the acceptable range. This flag serves as a
warning. Use results with caution.
NOTE: Reference ranges, critical limits, and reportable ranges can be
defined by the user (see Chapter 9, Settings). The test range and
measuring range are defined by the analyzer.
16. To perform another analysis, press Analysis.

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ABL80 FLEX Operator's Manual 4. Sample measurement

Sample information
Patient Follow the steps below to query for patient identification information during
information sample analysis:
query
Step Action
1. Enter an Accession Number, Patient ID, or Department (Patient) in
the patient information input screen.

NOTE: Accession Number is not available for external queries using

an HL7 communications protocol.
2. Press the Query button at the bottom of the Patient Information
input screen. When a match is found, all available demographic data
will be filled in automatically. This data may include patient ID,
name, department (patient), gender, date of birth, age, height, weight,
gestational age and birth weight.
3. • When searching on Accession Number or Patient ID, the system
will query for the most recent matching sample result. When
located, all available patient identification information will
automatically be filled in and the system will return to the Patient
Information screen.
• When searching on Department (Patient), the system will query for
all patients matching that department and will display a list of these
patients. Highlight the desired patient then press Accept. The
system will return to the Patient Information screen.
4. • If an external query (query to a networked database not located in
the analyzer) is unsuccessful, the analyzer will bring up a question
box asking the user if they would like to perform an internal query
instead.
• To perform an internal query (query to the database resident in the
analyzer) press Yes at the prompt.

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4. Sample measurement ABL80 FLEX Operator's Manual

Patient input See Chapter 9, Settings to enable the desired input fields for display and use
fields during sample analysis. Each input field can be enabled, made a mandatory input,
and the input retained as desired.

The symbol will appear next to any input field designated as mandatory.
Enabling the retain feature for any field will cause the last information entered in
this field to remain in the field until a new entry is made.
Each type of input field has its own method of data input. The different types of
controls are listed here:
• Text: a keyboard button will provide a keypad to enter alphanumeric text
• Date control: the ability to select the day, month or year then adjust the value
using arrows
• List box: provides a list of available selections

Sample The following illustrates the Patient Information input screen:

information
input screen

• Pressing the input field label moves the cursor to that field
• Pressing the field opens a sub-screen to manually enter data
• An external keyboard can be used to input data if desired (see the reference
manual, Chapter 9, Interfacing for information on connecting an external
keyboard)
• The internal or optional external scanner can be used to input data if desired

Sub-screen The following describes the sub-screen for entering data manually, using the on-
input screen keyboard. This sub-screen is accessed by selecting the desired field (not the
field label) from the Patient Information screen.

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ABL80 FLEX Operator's Manual 4. Sample measurement

• Next – press this button to save the information entered for this field and move
to the next field in the list
• Previous – press this button to save the information entered for this field and
move to the previous field in the list
• View List – press this button to return to the sample information input screen
• Scan – press this button to activate the internal scanner

Barcode Text field information may be entered by scanning a barcode, if desired. To use
scanning this feature, highlight the desired field then press the Scan button. Position the
barcode in front of the barcode scanner at the front of the analyzer until the scan is
completed.

Input field list The following table lists the available patient analysis input fields for all analyzer
versions.
Input Field Characteristics
Accession number Up to 12 text characters
Patient ID Up to 20 text characters
Last name Up to 20 text characters
First name Up to 20 text characters
Department Up to 20 text characters
Department (Patient) Up to 20 text characters
Room number Up to 20 text characters

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4. Sample measurement ABL80 FLEX Operator's Manual

Input Field Characteristics

Gender List choice of male, female and unknown
Date of birth Two methods to input the data, either by entering
discrete numeric values or as a selection on a calendar
date control
Patient temperature 12.0-45.0 °C
53.6-113.0 °F
Weight 0-500 kg
0-1100 lbs
Birth weight 0.00-20.00 kg
0-20000 g
0.0-705.5 oz
Gestational age 0-99 weeks
Height 0-300 cm
0-3 meters
0-118 inches
FO2(I) 0-100%
Liter flow Select from values between 0.0-2.0, 3-15, and Flush
(maximal flow)
sO2(m) 0.0-100.0% Oxygen saturation value measured from
another analyzer
ctHb(m) 1.0-28.0 g/dL
10-280 g/L
1.0-17.4 mmol/L
This field is meant to be used for a total hemoglobin
value measured from another analyzer
Baro 540-800 mmHg
72.0-106.7 kPa
This field is for recording the barometric pressure

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ABL80 FLEX Operator's Manual 4. Sample measurement

Input Field Characteristics

Sample site List choice of R. radial, L. radial, R. brachial, L.
brachial, R. femoral, L. femoral, arterial line, PA
catheter, umbilical cord, L. finger, R. finger, L. heel,
R. heel, scalp, bypass pump, other
NOTE: An alternate list is available in the ABL80
FLEX CO-OX analyzer with OSM software
configuration. This alternate list is designed for use
in the cardiac catheterization lab. Contact your local
Radiometer representative for details.
Draw time Two methods to input data, either by entering discrete
numeric values or as a selection on a calendar date
control
Drawn by Up to 20 text characters. The system defaults to the
person logged into the analyzer but can be edited
Order date Two methods to input data, either by entering discrete
numeric values or as a selection on a calendar date
control. The system default is the current date
Physician Up to 20 text characters
Note Up to 100 text characters

Input field list The following table lists the additional input fields available only with the ABL80
ABL80 FLEX FLEX CO-OX analyzer.
CO-OX
Input Field Characteristics

pO2(v– ) 0-760 mmHg

0-101.3 kPa

sO2(v– ) 0.0-100.0%
0.000-1.000
· 0-xxxx mL/min
VO2
0.0-xxx.x mmol/min
· 0.0-1000.0 L/min
Qt
VCO 0.0-1000.0 mL
FCOHb(1) 0.0-100.0%
0.000-1.000
FCOHb(2) 0.0-100.0%
0.000-1.000

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4. Sample measurement ABL80 FLEX Operator's Manual

Patient report

Fetal The ABL80 FLEX CO-OX analyzer can be configured to correct the oximetry
hemoglobin sample results for the presence of fetal hemoglobin (HbF). This correction can be
correction applied to all samples or only those whose HbF value is greater than 20%. See
Chapter 9, Settings (Reports – input fields) for more information.

Out of range The ABL80 FLEX CO-OX analyzer can be configured to suppress the reporting of
suppression hemoglobin fractions that the system calculates to be less than zero or greater than
100%. See Chapter 9, Settings (Reports – input fields) for more information.

Print results All analyzer versions can be configured to automatically print results at the
conclusion of every measurement. The number of printouts can be adjusted from 1
to 4 on the sample aspiration screen.

Additional printouts can also be initiated manually using the print icon on the
results screen.
To enable or disable automatic sample result printing, see Chapter 9, Settings
(Reports/Printout) for more information.

Recall results See Chapter 7, Data logs for instructions on recalling and printing stored results.

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ABL80 FLEX Operator's Manual 4. Sample measurement

Edit patient information

Introduction The user may edit information in any input field immediately after analysis, while
in the results screen. The user may also edit information after completion of
sample analysis, through the data logs recall screen. Permission to edit sample
information can be limited to specified users only. See Chapter 9, Settings for
information on security settings.

Edit following To edit patient information immediately after sample analysis, perform the
sample analysis following steps:
Step Action
1. At the end of a sample analysis the results are automatically
displayed.

2.
Press the pencil icon.

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4. Sample measurement ABL80 FLEX Operator's Manual

3. The input field entry screen will be displayed. Select the desired input
field and perform the necessary edit. See Sample information earlier
in this chapter for instructions on how to use this screen.

4. Press OK when all entries are complete.

NOTE: The results screen will now include an Edit Log tab to view
all edits for this sample.

Edit from recall To edit patient information from the Patient Recall screen after a sample result is
screen completed, perform the following steps:

Step Action
1. Select Menu  Data  Logs  Patient.

2. The recall screen will list general information for each stored patient
sample record.

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ABL80 FLEX Operator's Manual 4. Sample measurement

3. Locate the desired sample and highlight it.

NOTE: The most recent record is always located at the top of the
screen when first accessed. To sort the records by Patient ID or
patient name press the desired column header.
4.
Press the Patient detail button to view the results of this sample
5.
Press the edit button to open the edit screen. All input fields are
available for editing.
6. Once all desired edits are performed, press OK to store these changes
NOTE: All changes will be recorded in the edit log.

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4. Sample measurement ABL80 FLEX Operator's Manual

Patient edit log

Introduction All versions of the ABL80 FLEX analyzer record every edit performed on a
sample result. Only input field information is available for editing. A record of
these edits can be viewed on the Edit Log tab on the results screen and at the
bottom of each result printout (see Chapter 9, Settings to enable this feature).

Edit Log To view any edits performed on a sample record, perform the following steps:
Step Action
1. Select Menu  Data  Logs  Patient.
2. Select the desired patient sample record.
3. Press the Edit Log tab.
NOTE: If the patient record has no associated edits, this tab will not
appear.
4. A list of every input field edit that has occurred will appear on the
screen. The list includes the following information:
• Edit date/time
• The user logged into the analyzer
• The input field that was edited, followed by the original value, an
arrow, and the new value

NOTE: When patient temperature is edited, only the temperature

value is listed in the edit log. All derived parameters affected by the
temperature edit will be flagged with the edit symbol (▲).

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ABL80 FLEX Operator's Manual 4. Sample measurement

Approval

Introduction All ABL80 FLEX analyzer versions provide the ability to approve a sample result
prior to uploading those results to an HIS/LIS system. When enabled, this feature
provides an Approval button on the patient results screen. See Chapter 9, Settings
/ Data Communications for instructions on enabling this feature.

Status types There are four approval status types. The approval status for each sample is
displayed in the upper right corner of the results screen.
• Pending – the initial status of a sample result
• Approved – the results are considered acceptable and are sent to the HIS/LIS
system
• Rejected – the results are considered not acceptable and are not sent to the
HIS/LIS system. This result is sent to the RADIANCE/AQURE system with an
approval status of “rejected”.
• Rerun – the results are considered questionable and are not sent to the HIS/LIS
system. This result is sent to the RADIANCE/AQURE system with an approval
status of “rerun”.

Approval note The system also allows the entry of a free-text note which can be entered while
selecting the approval status. This note, along with the status, is transmitted to the
RADIANCE/AQURE system.

Editing Once an approval status is selected, the patient record cannot be edited.

Screen example When the Approval button is pressed, the user is allowed to select one of the three
status types. The analyzer also allows the user to enter a specific approval note
which is transmitted to the RADIANCE/AQURE system.

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 4. Sample measurement ABL80 FLEX Operator's Manual

RADIANCE/ The initial patient result record is automatically uploaded to the

AQURE approval RADIANCE/AQURE system with an approval status of pending. The approval
status can be determined in the RADIANCE/AQURE system. This status would
then be transmitted back to the ABL80 FLEX analyzer and stored and displayed
on the analyzer.

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ABL80 FLEX Operator's Manual 4. Sample measurement

FlexLink

Introduction All ABL80 FLEX analyzer versions can be used with the Radiometer FlexLink
system to obtain information about each sample, including parameter panel,
patient information and any processing instructions. This information is linked to
the unique sampler ID on a safePICO blood gas sampler (or linked to a sample
accession number). The analyzer will query the RADIANCE/AQURE system for
information on the identified sample. Results are then transmitted back to the
RADIANCE/AQURE system. This system ensures the correct results are linked to
the correct patient.

Enabling To enable the FlexLink feature in the analyzer, please see Chapter 9, Settings /
FlexLink FlexLink for further information. A RADIANCE/AQURE connection is required
to utilize the FlexLink system.

Sample analysis When FlexLink is enabled and Analysis is selected on the main menu, a screen
will be displayed for the entry of a sampler ID (or accession number). This number
can be scanned or manually entered. Once entered, the ABL80 FLEX analyzer will
query the RADIANCE/AQURE system for all available information on this
sample. A sample pre-registration screen will then appear displaying patient
demographic information. The user must press OK to accept this data and continue
with sample analysis.

Special The ABL80 FLEX analyzer will alert the user to several different conditions such
conditions as:
• Parameters not supported – If the FlexLink transmission includes a request for
measured or derived parameters that are not supported by the analyzer, a
warning message will appear. The user has the option of continuing without
these parameters if desired.
• No data found – If the system was unable to locate information on the sampler
ID (or accession number) entered, a message will appear. The user has the
option of continuing with sample analysis if desired.
• Derived value requires measured parameter not selected – If the system requests
a derived value that requires a measured value for its calculation but that
measured value was not requested, the system will automatically report the
necessary measured value for this derived value calculation.

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4-28
 5. Calibration

Introduction This chapter describes the calibration concept and reporting format for all versions
of the ABL80 FLEX analyzer.

In this chapter This chapter covers the following topics:

General information ...............................................................................5-2
Calibration reports .................................................................................5-4
tHb calibration .......................................................................................5-6
Standby mode .........................................................................................5-9
5. Calibration ABL80 FLEX Operator's Manual

General information
Introduction Sensor calibration is the process of relating sensor electrical outputs to known
analyte values. Traditionally, the calibration line slope (sensitivity) of each sensor
is derived from the electrical values (end points) obtained by measuring two
solutions with different analyte concentrations.
With the ABL80 FLEX QC3 automatic quality control system, the calibration
process includes the measurement of three solutions with different analyte
concentrations. These three measured values are used in different combinations of
two points each to establish three two-point calibration lines for each analyte. One
calibration line is consistently used to report sample results. All three calibration
lines are used together to evaluate system linearity.

System Cycle Calibration is performed during a System Cycle.

Schedule Calibration is performed every 8 hours, with the ability to increase that frequency
up to every 2 or 4 hours, if desired by the user. In the OSM software version of the
ABL80 FLEX CO-OX analyzer a System Cycle is performed every 24 hours.
A System Cycle is also performed following power-up if the analyzer has been
turned off for more than 10 minutes or if turned off without following the
appropriate power down process as described in this manual.

Blank In the ABL80 FLEX CO-OX analyzer a blank (zero) calibration of the CO-
calibration oximeter is performed, using a clear solution, during every System Cycle and
sensor cassette installation. A blank calibration is also performed at system power-
up. In the OSM software version of the ABL80 FLEX CO-OX analyzer the blank
calibration is also performed independently at the 12 hour period between System
Cycle events.

Drift The system can be configured to display a drift value for any parameter whose
drift value falls outside the acceptable drift criteria between System Cycles. See
Chapter 9, System Cycle Drift for instructions on enabling this feature. When
enabled and at least one parameter drift value is outside the acceptable criteria, a
Drift tab will appear on the System Cycle results screen. This information will
also be included in the System Cycle download file when this feature is enabled.

Inactivation If the calibration fails, the system will not allow the user to perform sample
analysis unless the failed parameter is inactivated. The analyzer can be configured
to automatically inactivate and re-activate failed parameters. See Chapter 9,
Settings for more information on configuring the Active Parameters features.

Non-QC3 The ABL80 FLEX analyzer with the BASIC software configuration does not
systems support the QC3 system. The ABL80 FLEX analyzer with the FLEX software
provides the option to install sensor cassette versions that do not support the QC3
system. In both cases, the calibration process consists of a single two-point
calibration only.

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ABL80 FLEX Operator's Manual 5. Calibration

In these systems, the main menu provides a selection to initiate a manual two-point
calibration in place of a manual System Cycle.
When using BASIC software or non-QC3 cassettes, the Schedule controls the
frequency of two-point calibrations. The user can set the frequency to every 2, 4 or
8 hours as desired.
Two-point calibration records can be reviewed in the 2 Point Cal logs.

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5. Calibration ABL80 FLEX Operator's Manual

Calibration reports
Description The calibration element of each System Cycle (or two-point calibration in a non-
QC3 system) establishes a new calibration line. The calibration sensitivity values
are stored in the System Cycle (or 2 Point Cal) database log and can be reviewed
under the Calibration tab in the System Cycle Recall (or Two Point Calibration
Recall) screen.

Calibration The calibration results from each System Cycle can be viewed in the System Cycle
records Data logs. This System Cycle is also recorded in the Event log. See Chapter 7,
Data logs for more information.
Follow the steps below to review calibration records.
Step Action
1. Select Menu  Data  Logs  System Cycle.
2. Use the scroll bar if necessary to locate the System Cycle record
desired.
The most recent record is always located at the top of the screen
when first accessed.
3.
Highlight the desired record then press the System Cycle detail
button to view the results.
4. Press the Calibration tab to view the calibration results.

Results that are out of range will be identified with an arrow (up to
signify out of range high or down to signify out of range low). In
addition, if the linearity evaluation is not successful, the sensitivity
value will be replaced by the acronym L/E (linearity error).

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ABL80 FLEX Operator's Manual 5. Calibration

5. Press the General tab to view general information about this

calibration event.

6. • Press the print button to generate a printout of the results

• Press the keyboard button to enter a free-text note

Status The Status of a calibration result documents the overall pass/fail criteria for this
event. If the overall status of the event is successful, then the Status is OK. In
addition to sensitivity failures, there are other failures that can occur during this
event. When the results of an event are not acceptable, one of the following
statements will be displayed in the Status line:
• List of parameters outside the acceptable sensitivity range
• Temperature error
• Air detection system messages
• Question mark signifying excessive drift since the last System Cycle

2-point The analyzer performs single two-point calibrations during the first few hours
calibrations following a new sensor cassette installation to provide more frequent monitoring
of the sensitivity values.
When the glucose or lactate sensor is active and five samples are performed within
15 minutes or 10 samples are performed within one hour, the system will perform
a series of additional two-point calibrations.
Records of these single calibrations can be viewed by selecting Data  Logs  2
Point Cal. These records also appear in the Event log.

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5. Calibration ABL80 FLEX Operator's Manual

tHb calibration
Description The suggested calibration frequency of the ABL80 FLEX CO-OX analyzer’s
spectrometer is once every three months using the ctHb Calibration Solution
S7770. See Chapter 9, Settings for details on setting the tHb calibration schedule.

Warning The analyzer can be configured to warn the user (yellow traffic light status) when
the tHb calibration is due. See Chapter 9, Settings for details on setting this System
Status warning.

Preparation Ensure the analyzer is in the Ready mode

tHb calibration Follow the steps below to perform a tHb calibration.

procedure
Step Action
1. Select Menu  Utilities  tHb Calibration.
2. • Press the Scan button
• Scan the ctHb Calibration Solution barcode for the ABL80 FLEX
CO-OX analyzer, located on the S7770 package insert. If the
scanner is not available, the barcode values may be manually
entered using the numeric keypad provided.

3. Once the analyzer scans the barcode, the system will automatically
proceed to the next screen.
NOTE: If the barcode was manually entered, the user must press OK
to proceed.

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ABL80 FLEX Operator's Manual 5. Calibration

4. The system will complete a blank calibration then prompt the user to
aspirate the calibration solution.

5. • Carefully open an ampoule of S7770 tHb Calibration Solution

• Raise the sample inlet probe
• Guide the inlet probe fully into the calibration ampoule solution,
ensuring the tip of the inlet probe is fully immersed in the QC
solution

• Press Aspirate.

6. When sample aspiration is complete, the analyzer provides a message

and two short beeps.
• Remove the ampoule
• Lower the inlet probe

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7. The system will proceed to perform the tHb calibration. Once

complete, the analyzer will display the calibration results.

8. The result screen displays a value for the cuvette factor (Fcuv). The
cuvette factor expresses the ratio of the effective light path of the
analyzer cuvette to that of a reference cuvette determined by
Radiometer.
The Fcuv acceptable range is 0.80 – 1.20.
NOTE: If the calibration result is not acceptable, the system will
retain the prior Fcuv and inform the user of this calibration failure.
9. Following a successful tHb calibration, the system will automatically
initiate a System Cycle.

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Standby mode
Introduction The ABL80 FLEX analyzer with BASIC software configuration and the ABL80
FLEX CO-OX analyzer with OSM software configuration both include a Standby
feature. This feature minimizes the consumption of calibration solutions,
optimizing the in-use life of the solution pack.
When in the Standby mode, the ABL80 FLEX analyzer postpones all System
Cycles and/or two-point calibrations until the Standby mode is exited. In this way,
calibration solution is conserved.
To take advantage of this feature in the ABL80 FLEX analyzer with BASIC
software, the system should remain in the Standby mode for more than 8 hours.
This is important because two-point calibrations only occur every 8 hours and the
system performs abbreviated flushes periodically during Standby and upon exiting
Standby.
To take advantage of this feature in the ABL80 FLEX CO-OX analyzer with OSM
software, the system should remain in the Standby mode for more than 12 hours.
This is important because blank calibrations of the CO-oximeter occur every 12
hours and, though there are no flushes during Standby, flushing does occur upon
exiting Standby.
Exiting Standby in less than 8 hours using BASIC software or 12 hours using
OSM software will result in an increased consumption of calibration solutions.

Entering The Standby mode can be entered manually or scheduled using the Standby
Standby Schedule screen. See Chapter 9, Settings for more information on setting a
schedule.
To manually enter Standby, follow the steps below.
Step Action
1. From the main menu, press the Enter Standby button.

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2. The system will display a text message providing the last day the
analyzer can remain in the Standby mode, based on the volume of
calibration solution remaining in the installed solution pack.
• To enter Standby press Yes
• To cancel, press No

Main menu While in Standby, the main menu will display an Exit Standby button. The traffic
during Standby light will be yellow and the message displayed in the upper left corner will say
Standby.
Depending on the method of entering Standby and the status of the consumables
installed, several messages will appear below this Exit Standby button providing
useful information to the user regarding the length of time the system can support
the Standby mode.

Consumable While in Standby, the system will monitor the status of the consumables and
replacement update messages on the main menu as applicable. These messages are presented
with the earliest date at the top of the list.
While in Standby, an expired solution pack can be on the analyzer to allow the
abbreviated flushes to continue until Standby is exited, at which time a new
solution pack must be installed to proceed with sample analysis. The solution pack
cannot support the Standby mode, however, if there is an insufficient volume of
remaining solution. The system will allow the replacement of a solution pack
without exiting the Standby mode. A two-point calibration will be required upon
exiting Standby if the solution pack was replaced during this Standby period.
The sensor cassette status (tests remaining and expiration status) do not directly
affect the Standby mode. A sensor cassette must be in place on the analyzer,
however, to support the Standby mode. The status of the sensor cassette is
displayed, when applicable, to communicate the readiness of the analyzer to
perform sample analysis upon exiting Standby.

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Exiting Standby To manually exit the Standby mode, follow the steps below.
Step Action
1. From the main menu press the Exit Standby button.
2. The analyzer will ask whether the user is sure they want to exit
Standby.
• To exit Standby press Yes
• To cancel, press No
NOTE: Upon exiting Standby, the system will perform a series of
flushes to prepare the system for sample analysis. If overdue, a two-
point calibration will also be performed prior to allowing sample
analysis.

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 6. Quality management

Introduction There are two methods of performing quality control to evaluate the performance
of the system. One method is automatic and the other is a manual method. The
ABL80 FLEX analyzer, using non-QC3 cassettes, and the ABL80 FLEX analyzer
with the BASIC software configuration are limited to the manual QC method only.
It is strongly recommended that all analyzers be monitored by at least one of these
two methods to ensure the system is functioning within specifications.
All ABL80 FLEX analyzers, if configured to support the QC3 feature, perform
periodic System Checks to provide further confidence that the analyzer is
performing to specification.
This chapter provides an overview of the automatic quality control and system
check features. It also describes how to perform a manual quality control
measurement and review the resulting QC data.

In this chapter This chapter covers the following topics:

Automatic quality control ......................................................................6-2
System Checks .......................................................................................6-6
Analysis Check ......................................................................................6-7
Manual quality control ...........................................................................6-8
Preparing manual QC solutions .............................................................6-9
Performing a manual QC measurement ...............................................6-10
Manual QC results ...............................................................................6-15
Out of range manual QC results...........................................................6-16
Manual QC plot....................................................................................6-17
Reviewing manual QC statistics ..........................................................6-19
Range+ QUALICHECK QC solution ..................................................6-20
RiliBÄK ranges ....................................................................................6-22
6. Quality management ABL80 FLEX Operator's Manual

Automatic quality control

Introduction This section describes the automatic method of the on-board quality control
system. With this method, all versions of the ABL80 FLEX analyzer provide
automatic quality control analysis for each parameter, measuring at least three
levels of quality control material for blood gases, electrolytes and glucose at user-
defined intervals. The ABL80 FLEX analyzer also measures two levels of quality
control for Hct. The ABL80 FLEX CO-OX analyzer measures three levels of
quality control for all oximetry parameters (two levels for the OSM software
configuration in the ABL80 FLEX CO-OX analyzer). The automatic quality
control system on all ABL80 FLEX analyzers is referred to as QC 3.

Schedule These automatic quality control measurements are performed during each System
Cycle. The interval of these events can be determined by the user. The default
interval is every 8 hours for most analyzer configurations. See Chapter 9, Settings
for more information on setting the System Cycle schedule.

Control ranges The assigned value and control range for each parameter and level are entered
automatically into the analyzer each time a new solution pack is installed. These
values can be viewed and printed from the System Information / Solution Pack
tab. See Chapter 7, Data logs for more information on the System Information
screen.

Acceptance The analyzer automatically assesses all automatic QC results and flags any result
criteria that is outside the control range. The user can choose, among several options, how
the system should react when a result falls outside the control range for a
parameter. These options include inactivating the individual parameter involved or
disabling patient analysis. To re-enable patient analysis or to re-activate the
individual parameter, a subsequent QC analysis must be successful for the subject
parameter(s) and level(s). The analyzer can be configured to automatically
inactivate and re-activate failed parameters. See Chapter 9, Settings for more
information on configuring the Active Parameters features.

QC records All automatic quality control results are stored in the analyzer’s database. See QC
result records further in this section for an example of a QC record. Also see
Chapter 7, Data logs for more information on downloading and printing these
records.

Description of The table of QC results provided with each System Cycle includes the following
results information:
• Solution ID: the Radiometer ID number of each solution
• Lot: the unique lot number for each of the solutions
• Cycles: the number of cycles remaining in each of the solution pouches at the
end of the System Cycle
• Parameter values: the measured QC results for each parameter, each level
• QC#: a unique sequential number assigned to each QC event

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ABL80 FLEX Operator's Manual 6. Quality management

QC result The quality control results from each System Cycle can be viewed in the System
records Cycle Data logs.
Follow the steps below to review quality control records.
Step Action
1. Select Menu  Data  Logs  System Cycle.
2. Use the scroll bar if necessary to locate the System Cycle record
desired.
NOTE: The most recent record is always located at the top of the
screen when first accessed.
3.
Highlight the desired record then press the System Cycle detail
button to view the results. The Quality Control tab will
automatically appear.

4.
Press the icon to print a copy of the current record.
5.
Press the icon to view a bias trend plot of the QC results.
6. Press the icon to view statistics of the QC results.

Automatic QC The QC plot displays results of all automatic quality control measurements for
plot each parameter and each solution level. All QC results are displayed in a bias plot.
This bias plot charts the difference between the measured value and the assigned
value for each parameter and each level (bias = measured – assigned). This
plotting method allows for continual analysis and trending of analyte performance
while eliminating variations due to solution lot changes.

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6. Quality management ABL80 FLEX Operator's Manual

The screen provides the following information and controls:

• Parameter: This selection box includes right and left arrows to move
sequentially through the list of possible parameters. It also provides a dropdown
list to directly select one parameter.
• Solution ID: This selection box includes right and left arrows to move
sequentially through the list of possible solutions. It also provides a dropdown
list to directly select one solution ID.
• QC Result: This box contains detailed information regarding the highlighted
data point on the graph. This data includes the analysis time, measured value,
control range (in brackets), bias value (the actual value plotted), lot number and
sensor cassette serial number.
• Plot area: The plot area provides data over an 11-day period. The upper and
lower control limits are represented by the upper and lower lines on the graph.
The middle line represents zero bias from the assigned value. The date span is
recorded at the bottom of the plot with the most recent date at the far right.
– Circular data points on the graph represent measured values that fell
within the control range
– Single arrows on the graph represent values that fell outside the control
range but are within the statistical range
– Double arrows on the graph represent values that fell outside both the
control range and the statistical range (outlier)
– A triangle at the bottom of the graph represents a measurement that did
not result in a numeric value, such as I/A (inactive) or N/C (not
calculated)
• Print icon: This button allows the user to print a copy of the plot displayed
• Group of arrows: This group of arrows moves the cursor to the right or left by
one data point, to the first or last point displayed, or adjusts the viewing window
to the next or previous set of data points.

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ABL80 FLEX Operator's Manual 6. Quality management

Automatic QC The analyzer provides a series of statistical tables to aid the user when reviewing
statistics automatic QC results.

Each tab on the screen provides information for one of the four solutions analyzed.
The tabs are labeled with the solution ID numbers. The following information is
provided for the currently installed solution pack:
• Lot: The solution pouch lot number
• n: The number of data points included in the statistical calculations
• Mean: The mean measured value of all data points for this parameter
• Mean Bias: The mean of the bias values (measured value – assigned value) for
all data points for this parameter
• SD: The standard deviation of all measured data points for this parameter
• CV%: The coefficient of variation of all measured data points for this parameter

Each tab on the screen also provides the following historical information, which
includes data for the current and last nine solution packs:
• n: The number of data points included in the statistical calculations
• Mean Bias: The mean of the bias values (measured value – assigned value) for
all data points for this parameter
• SD Bias: The standard deviation of the bias values for all data points for this
parameter

Printout This statistical information may be printed by pressing the print icon at the
bottom of the screen. Only the information on the currently displayed tab will be
printed.

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6. Quality management ABL80 FLEX Operator's Manual

System Checks

Description Every 30 minutes the analyzer will perform a System Check to verify the stability
and proper function of the analyzer. System Checks only occur in systems that
support the QC3 system. During System Checks, the analyzer will activate the
heater circuitry and air detection system. Measurements will be taken on all sensor
cassette sensors and a drift evaluation will be performed. In ABL80 FLEX CO-OX
analyzers, proper communication with the CO-oximeter will also be confirmed.

User While the analyzer is performing a System Check, the System Check icon
notification will be displayed at the top of the main menu to the left of the traffic light.

Interrupting a If the Analysis button is pressed during a system check, the analyzer will notify the
System Check user that a System Check is in progress and provide the opportunity to interrupt
the check. Other activities that may interrupt a System Check include manual QC,
manual initiation of a System Cycle, installing a sensor cassette or solution pack
and initiating a manual rinse.

Corrective The analyzer will automatically perform corrective actions when the results of a
action System Check are not acceptable. The first phase of this corrective action is to
flush the sensor cassette and repeat the measurements.
If repeat measurements are not acceptable, the system will automatically initiate a
System Cycle to fully evaluate the measurement system.
The event log records these corrective actions by recording the event along with
the acronym C/A (corrective action).

System Check Each System Check is recorded in the Event log. The status reflects whether the
records event was successful. System Check information can be downloaded if desired.
See Chapter 7, Data logs for more information.

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ABL80 FLEX Operator's Manual 6. Quality management

Analysis Check

Description With every blood sample analysis, a System Check with one-point calibration is
performed. This specialized System Check is termed an Analysis Check.
During analysis, the blood sample is aspirated into the analyzer and sensor
measurements are recorded. The sample is then flushed with solution 1 (from the
solution pack) and measurements of this solution are recorded. The measurement
results from both the sample and the flush (the one-point calibration) are used to
determine the final blood sample results. This method ensures compensation for
any sensor drift with each sample analysis.

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6. Quality management ABL80 FLEX Operator's Manual

Manual quality control

Introduction As a second method of quality control, the user has the option to analyze manual
quality control samples, if desired. Radiometer provides several types of quality
control material for use with the different analyzer versions.

QUALICHECK In the ABL80 FLEX analyzer (using both FLEX and BASIC software
4+ Control configurations) it is recommended to use the Radiometer brand quality control
Solution material QUALICHECK4+ for optimal performance and to take full advantage of
the analyzer’s design features such as temperature correction and automatic level
detection. See Chapter 13, Ordering information for more information.

QUALICHECK In the ABL80 FLEX CO-OX analyzer (using both CO-OX and OSM software
5+ Control configurations) it is recommended to use the Radiometer brand quality control
Solution material QUALICHECK5+ for optimal performance and to take full advantage of
the analyzer’s design features such as temperature correction and automatic level
detection. See Chapter 13, Ordering information for more information.

Range+ Radiometer provides an additional manual QC type for calibration verification.

QUALICHECK Instructions for use differ between the ABL80 FLEX analyzer and the ABL80
Control Solution FLEX CO-OX analyzer. Please see the section titled Range+ QUALICHECK
QC solutions further in this chapter for analyzer-specific instructions.

Manual Quality Quality control solutions are solutions with predetermined values that cover the
control clinically relevant ranges for the measured parameters, the objective being to
frequency simulate a patient sample. Manual quality control from Radiometer includes four
levels of solutions to cover the entire clinically significant range: low, normal and
high.
Quality control should be run to comply with special country, state and local
regulations. Additional quality control should be run after any troubleshooting or
preventive maintenance which might alter performance and whenever the
technician has questions about the performance of the analyzer.
An example of daily routine with the 4-level quality control system is given below:
Shifts per Day Quality Control Routine
3 One level tested at the beginning of each shift. The 4th level is
tested in the 8-hour shift with the highest volume of patient
samples.
2 Two levels at the beginning of each shift.
1 All levels are tested at the beginning of each shift.

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ABL80 FLEX Operator's Manual 6. Quality management

Preparing manual QC solutions

Introduction Proper handling and preparation of QC solutions are imperative to successful
quality control performance. Thoroughly read and follow the instructions for using
QC solutions, which accompany each box of quality control solutions.

Handling of Avoid warming the QC ampoule in your hands

ampoules before use. Excessive handling can alter the
expected results. When handling the ampoules
before opening, they should be held between two
fingers, as shown.

Storage Radiometer quality control material (QUALICHECK4+ and QUALICHECK5+)

temperature should be stored between 2 °C and 25 °C (35.6 °F to 77.0 °F), including up to a
total of 15 days at 32 °C (89.6 °F). Range+ QUALICHECK ampoules should be
stored between 2 °C and 8 °C (35.6 °F to 46.4 °F). If using other brands of QC
material, follow the manufacturer’s recommended storage guidelines.

Conditioning The quality control ampoule should be conditioned for at least five hours at a
prior to use constant temperature between 18 °C and 32 °C (64.4 °F to 89.6 °F) prior to use.
Deviation from this temperature can cause value changes resulting in out of range
QC results for oxygen, carbon dioxide and pH. Solutions are light and heat
sensitive.

Temperature The ABL80 FLEX analyzer supports temperature correction of Radiometer QC

correction ampoules. See Chapter 9, Settings for detailed instructions. For more information
on temperature correction please refer to the Radiometer publication Quality
Control Systems Reference Manual.

Open ampoule In order to ensure the reliability of the measurement, each QC ampoule must be
stability used immediately after opening, for one measurement on one analyzer only. Do
not open QC ampoules until the ABL80 FLEX analyzer displays the QC
Aspiration screen.

NOTES • Use only recommended QC solutions in the ABL80 FLEX analyzer.

• QC solutions must be aqueous based.

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Performing a manual QC measurement

Introduction This topic describes the procedure for performing manual quality control
measurements on all ABL80 FLEX analyzer versions.

Required • QUALICHECK4+ Blood Gas/Electrolyte Control Solutions (recommended for

materials the ABL80 FLEX analyzer)
• QUALICHECK5+ Blood Gas/Electrolyte Control Solutions (recommended for
the ABL80 FLEX CO-OX analyzer)
• Ampoule opener
• Protective gloves

NOTES • The reference ampoule temperature at which the package insert control ranges
are defined is 25°C. If the quality control solutions are equilibrated
(conditioned) at a temperature other than 25°C prior to measurement, entering
the exact temperature into the analyzer will ensure reliable blood gas and pH
results.
• To ensure accurate results, it is important that the quality control solutions are
conditioned properly before use. This includes verifying that the quality control
ampoule analyzed was kept at a known temperature for at least five hours for
complete temperature equilibration to occur.
• Ideally the quality control solution should be stored in the same location as the
analyzer. If the quality control solution and analyzer are kept in different
locations and at different temperatures, there is a risk that the temperature
correction entered into the analyzer will not match the equilibration
temperature of the solution when it is introduced into the analyzer. This
discrepancy would result in inaccurate and unreliable blood gas and pH results.
This possibility exists especially for analyzers that are used in operating rooms
or other point-of-care locations with different environmental conditions than
other locations in the institution.
• QUALICHECK+ solutions are light and heat sensitive. Avoid storage in direct
sunlight.
• Do not open QC ampoules until the analyzer displays the QC Aspiration screen.
• In order to ensure the reliability of the measurement, each QC ampoule must be
used immediately after opening, for one measurement on one analyzer only.

CAUTION Do not use perfluorocarbon-based quality control solutions.

Performing a Follow the steps below to perform a manual QC measurement:

QC
Step Action
measurement
1. Select Menu  Manual QC.

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ABL80 FLEX Operator's Manual 6. Quality management

2. In the ABL80 FLEX analyzer, if Radiometer QUALICHECK4+

control solutions have been set up in the analyzer (see Chapter 9,
Settings), two choices are displayed. Select one of the following two
control types:
• BG/Lytes – used to analyze aqueous QC ampoules containing pH,
blood gas, electrolyte, and glucose values
• Hct – used to analyze aqueous QC ampoules for conductivity-
based hematocrit measurements
3. In the ABL80 FLEX CO-OX analyzer, if Radiometer
QUALICHECK5+ control solutions have been set up in the analyzer
(see Chapter 9, Settings), selecting Manual QC will take the user
directly to the aspiration screen.
4. In all analyzer versions, if Other control solutions have been set up in
the analyzer, the drop-down menu will display all control levels.
Select the desired level.
5. The temperature of the QC ampoule may be reviewed and changed in
the QC Aspiration screen. The acceptable temperature input range is
15.0 °C to 32.0 °C (60.0-89.6 °F). If the ampoule temperature is
equilibrated to a temperature other than 25 °C, enter the actual
ampoule temperature.
NOTE: Temperature-correction of QC results is not applicable in the
OSM software configuration of the ABL80 FLEX CO-OX analyzer.
6. There are several options regarding the entry of the QC ampoule
temperature. See Chapter 9, Settings for detailed instructions. These
temperature options include:
• Ask before each analysis – activation of this feature causes a
dialog box to appear immediately prior to the QC Aspiration
screen. It requires the user to review the temperature value,
modify the temperature if desired, and press OK before
proceeding with analysis.
• Retain entry for 30 minutes – activation of this feature causes the
system to retain the last entered QC temperature for 30 minutes.
• Default QC Temperature – the default QC temperature value can
be left blank, effectively making entry mandatory. The default
temperature can also be set to any numeric value between 15.0 °C
and 32.0 °C.
7. To enter a different temperature value, use the numeric keypad next to
the temperature field.
8. If one or more QC lots are about to expire, or have expired, the screen
will display a warning message.

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9. Holding the ampoule between the

two fingers as shown, shake it
vigorously for at least 15
seconds.

10. Once the analyzer prompts, raise

the inlet probe to the first
position (45°).

11. Tap the top of the ampoule until all of the solution collects at the
bottom.
12. • Place the ampoule in the ampoule opener (1)
• Break off the ampoule neck (2).

13. • Guide the inlet probe into the

ampoule.
• Ensure the tip of the inlet
probe is fully immersed in the
QC solution.

14. Press Aspirate.

CAUTION: Place the ABL80 FLEX inlet probe in the QC ampoule
and immediately press Aspirate. Use great care to avoid aspiration of
air into the sample.
15. When sample aspiration is complete, the analyzer provides a message
and two short beeps. Remove the QC ampoule.

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16. Lower the inlet probe.

NOTE: The user can cancel the analysis by pressing the Cancel
button. The system will display a question box to verify the
termination of the QC analysis.
17. When a Radiometer solution ID is selected from the QC Ranges
screen (see Chapter 9), the analyzer will automatically recognize the
QC level of the measured sample.
18. Final results will appear on the screen in approximately 90 seconds
and print the results, if the Auto Print option is enabled (see Chapter
9, Settings for information on enabling the auto-print feature).

Level detection If the analyzer cannot determine the level of the sample measured, the system will
failure provide the opportunity for the user to select the level or discard the sample.
Step Action
1. If at the end of a manual QC sample measurement the QC level
cannot be determined automatically, the analyzer will display a
message box with two choices:
• Discard the sample
• Select a level manually
a. Press Discard Sample to discard the results. There will be no
record entry in the manual QC log but the measurement will be
recorded as an event in the Event log.
• Press Accept
• The analyzer will ask whether the user would like to perform
another manual QC measurement
• Press Yes or No as desired

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b. Press Select Level for access to a selection box to save the results
in the manual QC log.
• Press the selection box down arrow to display the choice of QC
levels
• Press the desired level. This result will be entered into the
manual QC log and will also be recorded in the Event file.
• Press OK

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Manual QC results
Copy of results Press the print icon to obtain a copy of the results. A copy will be
automatically printed if configured in Settings Reports  Printout.

QC plot Press the plot icon to view a plot of the QC results. Press the icon to
print a copy of the plot.

Upload of Press the upload icon to manually upload this record to a host computer.
results

Review previous Follow the steps below to review previous QC results.

QC results
Step Action
1. Select Menu  Data  Logs  Manual QC.
2. Use the scroll bar if necessary to locate the QC record desired.
NOTE: The most recent record is always located at the top of the
screen when first accessed. To sort the records by level, press the
column header "Level".
3.
Highlight the desired record then press the detail button to view
the results
4.
Press the print icon to print a copy of the current record.
5.
Press the upload icon to manually upload the current record to a
host computer. This icon is disabled if automatic data synchronization
is activated and/or there is no specified connection type.
6. Press the left and right arrow keys to scroll through other QC records
There is a window of information on the QC Results screen
displaying the current record number and the total number of results
stored in the record log. This can be a useful reference when scrolling
through records in the QC Results screen.

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Out of range manual QC results

Introduction An out of range QC result is indicated by marking the result with a () or () to
the left of the value. A down arrow indicates the results are below the control
range and an up arrow indicates values above the control range. In addition, results
on the screen are highlighted in red when they fall out of range.
An out of range QC result that falls outside the statistical range is indicated by a
red highlight (on the screen only) and a double arrow up or down to indicate above
or below the range. For a definition of the statistical range and to set the statistical
range, see Chapter 9, Settings.

Example The following screen provides an example of a QC result outside the control range
(and outside the statistical range).

Troubleshooting If the manual QC result is outside of the control range, perform the following:
procedure
Step Action
1. Ensure that all storage and handling criteria from the manufacturer's
package insert have been followed for the quality control solutions.
2. Ensure the correct QC ampoule temperature was entered into the QC
Aspiration screen.
3. Initiate a manual System Cycle (or two-point calibration) from the
main menu.
4. Re-analyze the failed QC level (using a new ampoule). Repeat a
second time if necessary.
• If the failed QC level remains out of range, replace the sensor
cassette
• If the situation persists after replacing the sensor cassette, replace
the solution pack
• If the situation persists after both consumables have been replaced,
contact your local Radiometer representative for assistance

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Manual QC plot
Introduction All ABL80 FLEX analyzer versions will plot all QC results stored in the current
QC file for each parameter and level. The plots are in a Levey-Jennings format.

Access to QC There are two areas of the software that provide access to the manual QC plot
plot feature:
• The QC Results screen immediately after QC sample analysis
• The QC Results screen under Data  Logs  Manual QC

Pressing the icon will open the Manual QC Plot screen.

Press Close to return to the previous screen.

QC plot • Parameter: This selection box includes right and left arrows to move
description sequentially through the list of possible parameters. It also provides a dropdown
list to directly select one parameter.
• Solution ID: This selection box includes right and left arrows to move
sequentially through the list of possible solutions. It also provides a dropdown
list to directly select one solution ID.
• QC Result: This box contains detailed information regarding the highlighted
data point on the graph. This data includes the analysis time, measured value
and the QC ampoule lot.
• Plot area: The plot area provides data over an 11-day period. The upper and
lower control limits are represented by the upper and lower lines on the graph.
The middle line represents zero bias from the assigned value. The date span is
recorded at the bottom of the plot with the most recent date at the far right.
– Single arrows indicate a value that fell outside the control range but are
within the statistical range.
– Double arrows indicate a value that fell outside both the control range
and the statistical range.

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– A triangle at the bottom of the graph represents a measurement that did

not result in a numeric value, such as I/A, N/E, *** or ###.
• Group of arrows: This group of arrows moves the cursor to the right or left by
one data point, to the first or last point displayed, or adjusts the viewing window
to the next or previous set of data points

Print the QC Print the currently displayed QC graph by pressing the print icon. It will print
plot the prior 31 days worth of QC results, starting with the highlighted value on the
screen.

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Reviewing manual QC statistics

Introduction The analyzer will maintain a current mean, standard deviation (SD) and coefficient
of variation (CV%) for each parameter of each manual QC level analyzed.
NOTE: A minimum of two QC runs of a level are necessary to report statistics
which update with each run of QC.

Procedure Step Action

1. Select Data Logs  Manual QC
2.
Press the statistics icon.

3. The QC Statistics screen displays a tab for each level of QC. To

review a level's statistics, press the Level tab at the top of the screen.
The number (n), mean, standard deviation (SD), and percent
coefficient of variation (CV%) for each analyte will be available for
each level. At least two data points are required before statistical
information is reported.

Printout of
statistics Press the print icon to obtain a printout of the reported statistics.

QC plotting Press the plot icon to view a plot of the QC results.

Reset The manual QC statistics will automatically be reset when a new lot number is
entered for a manual QC level. The lot number is entered in the Settings  Manual
QC  Ranges screen.

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Range+ QUALICHECK QC solution

Introduction For all analyzer versions, Range+ QUALICHECK samples should be analyzed in
the Manual QC mode. It is important that steps be taken to ensure any statistical
data (e.g. mean, SD and CV%) for active manual QC lots (from QUALICHECK4+
and QUALICHECK5+ solutions) are not affected by these additional Range+
QUALICHECK samples. This can be accomplished by modifying the solution ID
or QC lot number in the Manual QC Ranges setup screen. See the analyzer-
specific instructions below for setting up and using Range+ QUALICHECK
material.

ABL80 FLEX Follow the steps below to analyzer a Range+ manual QC sample in the ABL80
analyzer FLEX analyzer.
Step Action
1. Proceed to the manual QC Ranges setup screen to modify the settings
in preparation for the Range + measurement by selecting Menu 
Settings  Manual QC  Ranges.
2. Under Solution ID for Level 1, Level 2 and Level 3, select Other
from the drop-down list.
3. Press OK.
4. From the main menu select Menu  Manual QC.
5. Select the level of Range+ QUALICHECK solution to be analyzed.
6. Thoroughly mix the Range+ QUALICHECK solution.
7. When prompted by the analyzer, lift the sample inlet flap.
8. Open the ampoule.
9. Guide the inlet probe into the ampoule solution. Ensure the tip of the
inlet probe is fully immersed in the QC solution.
10. Press Aspirate.
11. When sample aspiration is complete and the system prompts, remove
the QC ampoule.
12. Lower the sample inlet flap.
13. Final results will appear on the screen in approximately 90 seconds
and print results if the Auto Print option is enabled.
14. Repeat steps 4 through 13 until all Range+ QUALICHECK samples
have been measured.
15. Return to the manual QC Ranges setup screen and return the Solution
ID field to its original setting.

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ABL80 FLEX Follow the steps below to analyze a Range+ QUALICHECK manual QC sample
CO-OX in the ABL80 FLEX CO-OX analyzer.
analyzer
Step Action
1. Proceed to the manual QC Ranges setup screen to modify the settings
in preparation for the Range + measurement by selecting Menu 
Settings  Manual QC  Ranges.
2. Ensure the Solution ID fields for all levels are set to the Radiometer
solution ID’s (i.e. S7730, S7740, S7750 and S7760).
3. Remove (and leave blank) or modify the current QC solution lot
numbers entered in the Ranges setup screen for levels 1, 2 and 3.
NOTE: Performing this step ensures that these Range+
QUALICHECK results are not included in the daily QC statistics.
4. Press OK.
5. From the main menu select Menu  Manual QC.
6. Thoroughly mix the Range+ QUALICHECK solution.
7. When prompted by the analyzer, lift the sample inlet flap.
8. Open the ampoule.
9. Guide the inlet probe into the ampoule solution. Ensure the tip of the
inlet probe is fully immersed in the QC solution.
10. Press Aspirate.
11. When sample aspiration is complete and the system prompts, remove
the QC ampoule.
12. Lower the inlet probe.
13. Final results will appear on the screen in approximately 90 seconds
and print results if the Auto Print option is enabled.
14. Repeat steps 5 through 13 until all Range+ QUALICHECK samples
have been measured.
15. Return to the manual QC Ranges setup screen and return the lot
number fields to their original values.

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RiliBÄK ranges
Introduction An additional set of ranges can be defined in all ABL80 FLEX analyzer versions
for use with automatic QC results during a System Cycle as well as manual QC
results during manual QC testing. This feature must be enabled by your
Radiometer service representative.
When this feature is enabled, an additional selection will be present under Settings
/ Manual QC titled RiliBÄK Ranges. This new screen contains one tab for each
measured parameter. A QC control range for each of these parameters can be
defined by using the settings on this screen to establish a span. This span will be
used in conjunction with the mean (assigned) value from the existing System
Cycle or manual QC control range to define a second QC control range.
These RiliBÄK ranges can be applied to either or both manual QC and System
Cycle automatic QC results.
When enabled, the system will automatically compare the manual QC control
range (as entered in the Settings / Manual QC / Ranges screen) and the RiliBÄK
QC control range. It will then reference the more narrow (tighter) of the two
ranges to determine whether QC results are successful or flagged as out of range
for that manual QC result.
When enabled, the system will also automatically compare the automatic QC
control range (from a System Cycle) and the RiliBÄK QC control range. It will
then reference the more narrow (tighter) of the two ranges to determine whether
QC results are successful or flagged as out of range for that System Cycle
automatic QC result.
To document which type of range is being applied, the system will display one of
three letters with the QC result for each parameter:
• M – Manufacturer range, either the Manual QC package insert range scanned in
the QC Ranges setup screen or the System Cycle automatic QC range as
programmed in the solution pack iButton
• L – Laboratory range, a Manual QC range that was manually entered in the QC
Ranges setup screen
• R – RiliBÄK range, as defined in the setup screen, is being applied to this
manual QC or System Cycle QC result

Setup screen See Chapter 9, Settings / RiliBÄK ranges for information on setting up RiliBÄK
range requirements.

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 7. Data logs

Introduction Data logs are historical files containing all patient, calibration and quality control
measurements as well as a listing of pertinent system events. All data obtained is
automatically stored in these logs from which the data can be viewed on the
analyzer or downloaded to an external storage device.

In this chapter This chapter covers the following topics:

General information ...............................................................................7-2
Logs ........................................................................................................7-4
Upload ....................................................................................................7-5
Download ...............................................................................................7-8
Data maintenance .................................................................................7-11
System information ..............................................................................7-13
7. Data logs ABL80 FLEX Operator's Manual

General information
Introduction All ABL80 FLEX analyzer versions contain the following data logs:
• Patient
• Manual QC
• System Cycle (not supported in the BASIC software configuration)
• 2-point cal
• System Check (not supported in the BASIC software configuration)
• Events
• Security
Patient, Manual QC, System Cycle and 2 Point Cal logs hold 500 records in each
file. The System Check, Event and Security logs hold 1500 records each.
In addition, the ABL80 FLEX CO-OX analyzer contains a tHb Calibration log
which holds 500 records. In the OSM software version of the ABL80 FLEX CO-
OX analyzer, a SC Check log is also included and holds 500 records.

Patient log The patient log stores the chronological record of all sample results run in the
Analysis mode. Each record contains the measured and derived parameters,
reference ranges and critical limits, and all input field information. It also records
the temperature corrected values, sample type, sensor cassette lot and serial
number, user, sequence number, analyzer name, whether any correlation values
were applied, edit information, whether any air detection message occurred or the
sample was run following a failed QC measurement, and the status of each record.

Manual QC log The manual QC log stores the chronological record of all manual quality control
samples and acceptable QC ranges. It also records the user, sequence number,
record number, QC lot, QC temperature, sensor cassette lot and serial number, and
the status of each record. Both the QC download file and the WDC download file
can be created using data from the manual QC log.

System Cycle The System Cycle log stores the chronological record of all automatic and manual
log System Cycles, including successful installations, re-installations, and failed
installations for both sensor cassettes and solution packs. Each record contains the
sensor calibration (sensitivities) and quality control results, along with date and
time, solution pack serial number and sensor cassette lot and serial number. It also
records the user, sequence number, record numbers and status of each record.

2 Point Cal log The 2 Point Cal log stores those single two-point calibrations performed during and
just following a sensor cassette initialization. This log also stores all two-point
calibrations that occur while using non-QC3 systems. Each record contains the
sensor sensitivities, along with date and time, solution pack serial number and
sensor cassette lot and serial number. It also records the user, sequence number,
record number, and status of each record.

System Check The System Check log includes all data from each System Check event. This data
log is not available for review on the analyzer but can be downloaded and reviewed in

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ABL80 FLEX Operator's Manual 7. Data logs

a spreadsheet format. A record of each System Check is also recorded in the event
log with an overall status of that event.

Event log The event log stores the chronological record of all events including installations,
System Cycles, System Checks, manual QC results, parameter inactivation/re-
activation, and out of range patient sample results. It also records the user and
status of each record.

Security log The security log records every logon and logoff attempt with the analyzer. It
records the time, user name, action (logon or logoff) and the status of the activity.
The security log is only activated when the system security is configured to require
a password. See Chapter 9, Settings to configure password requirements.

tHb calibration The ABL80 FLEX CO-OX analyzer has an additional log named the tHb
log Calibration log. This log contains all hemoglobin calibration event results. It
records the analysis time, cuvette factor and status of each calibration event.

SC Check log The ABL80 FLEX CO-OX analyzer with OSM software configuration has an
additional log named the SC Check log. This log contains the record of every SC
Check performed. It records the solution conductivity values recorded during this
check. This check is performed when a new cassette is installed and when exiting
Standby to ensure there is no blockage in the cassette fluid pathway.

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7. Data logs ABL80 FLEX Operator's Manual

Logs
Accessing logs Follow the steps below to view records from the data logs.
Step Action
1. Select Menu  Data  Logs.
2. Select the desired log type from the list of choices.
3. Each log will contain columns of data to identify the individual
record.

4. Each column can be sorted by pressing the column header. This will
cause the list of records to be sorted in A to Z order for the column
selected.
5. Highlight the desired record then press the detail button to view the
detailed information of that record.

Edit patient Follow the steps below to edit a patient record.

record
Step Action
1. Select Menu  Data  Logs  Patient.
2.
Locate the desired record and press the detail button
3. In the results screen, press the edit button. A screen will open
listing all input fields.
4. Edit all fields as desired.
5. Press OK to store these changes.
NOTE: All changes will be recorded in the patient edit log and can be
viewed in the patient results screen, printout, and in the edit log.
NOTE: The Patient Results screen will have an additional tab
labeled Edit Log when there is at least one edit stored for that
particular record. If there are no edits in the system then this tab does
not appear.

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ABL80 FLEX Operator's Manual 7. Data logs

Upload
Introduction Individual records can be manually uploaded from the analyzer to an external
network. The available record types are patient, manual QC, System Cycle, 2 Point
Cal and WDC. In the ABL80 FLEX CO-OX analyzer the tHb calibration records
are also available for upload.
To upload data records a communication channel must be established under
Settings  Setup  Data Communications.

Upload a record Follow the steps below to upload a patient record. Other record types can be
uploaded in a similar manner.
Step Action
1. Select Menu  Data  Upload  Patient.

2. Locate and highlight the desired records for upload.

NOTE: Records already uploaded will be marked with an asterisk in
the Uploaded column.
3. Select the desired communication channel at the bottom of the screen.
4. Press Upload.
5. Once the upload process is complete, the system will display a
completion message.

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WDC upload A WDC report can be manually uploaded to the Radiometer QA Portal using this
upload feature. Ensure a TCP/IP address is defined in the QA Portal setup screen.
See Chapter 9, Settings to enter this address.
Follow the steps below to manually upload a WDC report.
Step Action
1. Select Menu  Data  Upload  WDC.

2. On the Initiate tab select the desired year and month from the drop-
down list of choices.
3. Press OK to begin the upload. A progress bar will communicate the
upload progress and notify the user when the upload is complete.

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ABL80 FLEX Operator's Manual 7. Data logs

Schedule WDC A WDC report can be scheduled to automatically upload to the Radiometer QA
upload Portal using this upload feature. Ensure a TCP/IP address is defined in the QA
Portal setup screen. See Chapter 9, Settings to enter this address.
Follow the steps below to establish an upload schedule for a WDC report.
Step Action
1. Select Menu  Data  Upload  WDC. Select the Schedule tab.

2. Press the Enable check box to enable this feature.

3. Select whether to upload the QC results in one of four time schedules:
• Each record – the system will upload each QC result at the time of
each measurement
• Daily – the system will upload all QC results, not previously
uploaded, once per day at the time specified
• Weekly – the system will upload all QC results, not previously
uploaded, once per week on the day of week and time specified
• Monthly – the system will upload all QC results, not previously
uploaded, once per month on the date and time specified
4. Once all selections have been made, press OK.

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Download
Introduction This topic describes the download procedure and how to view the downloaded
files.
The analyzer will download the following data to an external storage device:
• Patient data – patient sample result information, including all edit information
• Manual QC data – manual QC results for all levels
• System Cycle data – calibration sensitivity values and QC results from all
System Cycles (not available with the BASIC software configuration)
• tHb Calibration data (ABL80 FLEX CO-OX analyzer only) – the cuvette factor
from each tHb calibration
• 2 Point Cal data – sensitivity values calculated during the two-point calibrations.
In QC3 systems two-point calibrations are performed during and within the two
hours following sensor cassette initialization. In non-QC3 systems all calibration
records are two-point calibrations.
• System Check data – measured endpoint data from all System Checks (not
available with the BASIC software configuration)
• SC Check data (ABL80 FLEX CO-OX analyzer with OSM software
configuration only) – the solution conductivity values recorded during a SC
Check
• Event data – all activities considered analyzer events
• Security data – all logon and logoff activity
• WDC – QC results from System Cycles and manual QC in the proper format for
use in the Radiometer Worldwide Datacheck (WDC) program
This information can be stored on a storage device and reviewed on a personal
computer using Microsoft Excel.
NOTE: The WDC download does not include the option to delete records.
All fields are automatically downloaded for Manual QC, System Cycle, 2 Point
Cal, System Check, Event, Security and WDC logs.

Patient The user can select which data fields to download from the patient data log using
download the Download Patient Setup screen. Refer to Chapter 9, Settings to select and
options verify the fields for download.
NOTE: When the user chooses to Delete records after download during the
patient download process, all patient information fields will be deleted, whether or
not these fields were selected to be downloaded.

Downloading Follow the steps below to download files from the data log to an external storage
files device. These files are stored in a tab-delimited format.
Step Action
1. Select Menu  Data  Download.

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ABL80 FLEX Operator's Manual 7. Data logs

2. Select the file to download (Patient, Manual QC, System Cycle, tHb
Calibration, 2 Point Cal, System Check, SC Check, Events or
Security). See Downloading WDC Files further in this section for
creating a WDC download.
3. Connect a storage device into one of the USB ports at the rear of the
analyzer or insert a CD into the CD drive.
NOTE: Use of a CD-R is recommended for optimal CD drive
reliability.
4. On the Download screen, select either CD or USB drive depending on
which type of storage device is being used.
5. Select Delete records after download if desired.
NOTE: The Events and Security download screens do not include this
option. Once maximum capacity is reached, these logs automatically
delete the oldest record when a new record is stored.
NOTE: For patient download records, the user can select which fields
of data to download (see Chapter 9, Settings). All patient data fields
will be deleted, whether or not they were selected for download when
Delete records after download is selected.
6. Select Download end points if desired. This option will download
both the standard information and the electronic end point values from
each parameter measurement. This data is meant for detailed
troubleshooting. It is not recommended for routine record-keeping
purposes.
NOTE: This option is not available for Events and Security logs nor
is it available for tHb Calibration logs or SC Check logs in the ABL80
FLEX CO-OX analyzer.
7. Press Download.
RESULT: The system will proceed to download the selected file. The
status messages on the screen will update as it progresses through the
various processes.

Viewing Follow the steps below to view files from the data log.
downloaded files
Step Action
1. Connect the storage device containing the downloaded information to
a personal computer with a Microsoft Windows operating system
(Windows 98 or later versions).
2. Open My Computer
3. • Right click on the icon of the storage device.
• Select Open.

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7. Data logs ABL80 FLEX Operator's Manual

4. Patient, manual QC, System Cycle, 2 Point Cal, System Check, Event,
and Security logs appear named as the date and time of the
downloaded procedure along with the serial number of the analyzer.
The extension defines the file as Patient (pat), QC (MQC), System
Cycle (SysCyc), tHb Cal (tHb), 2 Point Cal (TPCal), System Check
(Chk), SC Check (SCChk), Event (EVT) or Security (Sec).
EXAMPLE: 0603040955_300045.pat
060304is the date, March 4, 2006
0955 is the time, 9:55 am
300045 is the serial number of the analyzer
pat is the file extension (Patient)
5. Data files from the WDC download are designed for use with the
Radiometer WDC program. These files cannot be viewed through
Microsoft Excel or any other text based spreadsheet program. Data
files from the WDC download have the following naming convention:
EXAMPLE: 2006_03_300045.csv
2006_03 is the date, March 2006
300045 is the serial number of the analyzer
csv is the file extension
See the next section Downloading WDC files for instructions on
downloading this log file.
6. Right click the file icon and select Open with.
7. Select Microsoft Excel or any other text based spreadsheet program.
RESULT: The data appears in spreadsheet format and is available for
reviewing, sorting, editing and printing.

Downloading Follow the steps below to download WDC files from the data log to an external
WDC files storage device.
Step Action
1. Select Menu  Data  Download.
2. Select WDC.
3. Connect a storage device to one of the USB ports at the rear of the
analyzer.
4. Select the desired month and year from the list box selections.
5. Press Download.
RESULT: The system will proceed to download the selected file.
6. Use this downloaded file to send your monthly QC data to
Radiometer.

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ABL80 FLEX Operator's Manual 7. Data logs

Data maintenance
Introduction The data maintenance selection provides a means to initiate a compression of the
database and to set a schedule to automatically initiate a compression of the
database.
Database compression must be performed periodically in order to maintain optimal
performance of the database. It is recommended to schedule this maintenance once
a day. The minimum default setting is once a week on Sunday mornings at 2 a.m.

Initiate data Follow the steps below to initiate a compression routine for the database.
maintenance
NOTE: The compression process may take up to 15 minutes to complete. The
length of time is dependent on how often the process is performed.
Step Action
1. Select Menu  Data Maintenance Initiate.

2. Press Compress Database.

3. The system will display the warning message, "This process may take
several minutes to complete. Are you sure you want to continue?"
• Press Yes to continue with the compression process
• Press No to cancel this action

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7. Data logs ABL80 FLEX Operator's Manual

Schedule data Follow the steps below to schedule a specific time for automatic data maintenance.
maintenance
Step Action
1. Select Menu  Data  Maintenance  Schedule.

2. Select the day(s) of the week to perform database compression by

pressing the corresponding check boxes. A Select All button is
provided to conveniently check all days of the week, if desired.
3. Set the Time of Day.
• Press the input box for the hour of the day then use the up and down
arrow buttons to adjust the value
• Press the input box for the minutes of the day then use the up and
down arrow buttons to adjust the value
• Press the AM/PM input box then use the up and down arrow buttons
to adjust the value
4. When all entries are completed, press OK.

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ABL80 FLEX Operator's Manual 7. Data logs

System information
Introduction The System Information screen provides information regarding the basic
configuration and status of the various analyzer components. There are up to five
tabs of information, depending on what features are enabled.

System Follow the steps below to view and print the information provided in the System
information Information screen.
Step Action
1. Select Menu  Data  System Information.
2. The first tab is labeled General and includes the following
information:
• Analyzer serial number and name
• List of active parameters
• Time of last and next System Cycle (or 2 Point Cal) and System
Check
• Software and database versions and operating system information
3. The second tab is labeled Solution Pack and includes the following
information:
• Install and expiration dates
• Lot number and serial number
• Number of cycles remaining in each solution pouch
• Calibration target values for all solutions, all parameters
• QC assigned values (during System Cycles) and acceptable ranges
for all solutions, all parameters (not available with the BASIC
software configuration)
NOTE: If RiliBÄK Ranges is enabled for System Cycles, this tab will
display both the manufacturer ranges and the RiliBÄK ranges.
4. The third tab is labeled Sensor Cassette and includes the following
information:
• Install and expiration dates
• Number of tests
• Number of tests remaining
• Lot and serial number
• Configuration
• A button to navigate directly to the most recent System Cycle or 2
Point Cal results
5. The fourth tab will only appear if a manual QC schedule has been
established under Setting  Manual QC  Schedule. This tab includes
a list of the times due for the next manual QC sample for each level

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6. The fifth tab will only appear if a network connection has been
setup under Settings  Setup  Data Communications. This tab
includes the connection status and number of records for each
defined connection.

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 8. Utilities

Introduction The Utilities section provides a means of performing a variety of actions, from
installing disposables to upgrading software.

In this chapter This chapter covers the following topics:

Installation – sensor cassette ..................................................................8-2
Installation – solution pack ....................................................................8-5
Counter ...................................................................................................8-7
Settings transfer......................................................................................8-9
tHb calibration......................................................................................8-11
Rinse.....................................................................................................8-12
Software upgrade .................................................................................8-13
Eject CD ...............................................................................................8-14
8. Utilities ABL80 FLEX Operator's Manual

Installation – sensor cassette

Introduction All ABL80 FLEX analyzer versions provide step-by-step screen instructions for
installing or replacing the sensor cassette. The allowable tests remaining for each
cassette is automatically monitored and the user notified when replacement is
necessary. The user can also set up a warning period prior to exhaustion of all
allowable tests. See Chapter 9, Settings / System status for information on setting
up this warning period.

Sensor cassette Follow the steps below to replace the sensor cassette in the ABL80 FLEX analyzer.
replacement –
Step Action
ABL80 FLEX
analyzer 1. Select Menu  Utilities  Install  SC80.
2. If a sensor cassette is not currently installed on the analyzer, proceed
to step 4.
If a sensor cassette is currently installed on the analyzer, the system
will first remove all fluid from the current cassette. On the screen the
status message will state:
Please wait, removing excess fluid from sensor cassette...
The screen will then prompt the user to remove the old sensor cassette.
3. To remove a sensor cassette, perform
the following steps:
• Unwrap the pump tubing from the
roller wheel
• Press up on the cassette latch at the
bottom of the cassette, grasp the
cassette body, and pull the cassette
straight off the analyzer
4. Clean the sensor cassette nest and waste drain area with a clean, lint-
free cloth moistened with water. Cleaning the waste drain area with
each sensor cassette installation will help prevent debris from entering
the internal waste tubing. This debris can accumulate and result in
internal tubing blockages.
NOTE: Never wipe the sensor cassette pins or analyzer pin
connection port with a damp cloth
5. To install a new sensor cassette perform the following steps:
• Tear open the foil pouch containing the new cassette and remove the
cassette
• Open the plastic casing surrounding the cassette and lift the cassette
out
• Align the cassette to the front of the analyzer and push the cassette
straight onto the analyzer

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ABL80 FLEX Operator's Manual 8. Utilities

• Press on the raised circle at the

center of the cassette body (see
diagram) until a snap is heard.
This signifies a complete
connection has been made.
• Wrap the pump tubing around the roller wheel
6. Press OK on the screen to proceed to the sensor initialization phase.
7. As the fluid enters the sensor flow cell,
repeatedly pull down and release the
pump tubing to dislodge any air
bubbles that may be present in the
tubing.

8. When the installation is complete, the system will display a message

on the screen, and then return to the main menu.

Sensor cassette Follow the steps below to replace the sensor cassette in the ABL80 FLEX CO-OX
replacement – analyzer.
ABL80 FLEX
Step Action
CO-OX
analyzer 1. Select Menu  Utilities  Install  SC80 CO-OX.
2. If a sensor cassette is not currently installed on the analyzer, proceed
to step 4.
If a sensor cassette is currently installed on the analyzer, the system
will first remove all fluid from the current cassette. On the screen the
status message will state:
Please wait, removing excess fluid...
The screen will then prompt the user to remove the old sensor cassette.
3. To remove a sensor cassette press up
on the cassette latch at the bottom of
the cassette, grasp the cassette body,
and pull the cassette straight off the
analyzer

4. Clean the sensor cassette nest and waste port with a clean, lint-free
cloth moistened with water.
NOTE: Never wipe the sensor cassette pins or analyzer pin
connection port with a damp cloth
5. To install a new sensor cassette perform the following steps:
• Tear open the foil pouch containing the new cassette and remove the
cassette
• Lift the cassette from the shipping tray
• Press Continue

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8. Utilities ABL80 FLEX Operator's Manual

6. Align the cassette to the front of the analyzer and push the cassette
straight onto the analyzer
• Press firmly over the indented
circle at the center of the
cassette body (see diagram)
until a snap is heard.
• Ensure the inlet probe is
completely lowered.
7. Press OK to proceed to the sensor initialization phase.

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ABL80 FLEX Operator's Manual 8. Utilities

Installation – solution pack

Introduction All ABL80 FLEX analyzer versions provide step-by-step instructions for installing
or replacing the solution pack. The fluid levels in each pouch are automatically
monitored. The user is notified when replacement is necessary. The user can also
set up a warning period prior to exhaustion of fluids. See Chapter 9, Settings /
System status for information on setting up this warning period.

CAUTION: The solution pack contains four solution pouches and a waste pouch. With use, the
waste pouch will contain blood and other biohazardous fluids. Avoid contact with
the waste inlet port and clean any spillage. Handling and disposal of a used
solution pack should comply with all required biohazardous regulations per your
institutional guidelines.

NOTE: Never open the solution pack door unless instructed to do so by the system.
Opening the door at inappropriate times may corrupt the information stored on the
smart chip of the solution pack, causing the pack to be unusable.

Solution pack Follow the steps below to replace the solution pack.
replacement
Step Action
1. • Select Menu  Utilities  Install  Solution Pack
• If a solution pack is not currently installed on the analyzer, proceed
to Step 4
2. Follow the instructions on the screen to
remove the old solution pack.
• Press down on the solution pack door
latch

• Lower the door completely. This will

release the solution pack.
• Remove the old solution pack and
discard per your institution’s
biohazardous guidelines

3. Press Continue.
4. Remove the foil tape from the new
solution pack.

5. Slide the new solution pack fully into the solution pack cavity.

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8. Utilities ABL80 FLEX Operator's Manual

6. Raise the door and press near the top of

the latch (see diagram) until a snap is
heard. This signifies the door is
completely latched closed.

7. Press OK on the screen to complete the installation.

NOTE: The analyzer will automatically initiate a solution pack
verification check following solution pack replacement when there is a
sensor cassette installed. This check verifies the integrity of the new
solution pack.
NOTE: A verification check is available in the ABL80 FLEX analyzer
with BASIC SW and in all systems that support the QC3 feature.

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ABL80 FLEX Operator's Manual 8. Utilities

Counter

Introduction The analyzer maintains a count of the number of patient sample analyses, System
Cycles, 2-point calibrations and manual QC measurements performed. This feature
allows the user to track usage by user-defined time periods.
A printout of the current counts for each activity can be created and the counter
reset to begin a new time period.

Printout Follow the steps below to create a printout of the sample counter status.
Step Action
1. Select Menu  Utilities  Counter.
2. The following screen will appear:

3. Press Print to generate a copy of the current counts.

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8. Utilities ABL80 FLEX Operator's Manual

Reset the Follow the steps below to reset the counter in all categories to zero.
counter
Step Action
1. From the Counter screen, press the Reset button.

2. The analyzer will display a confirmation box. Select Yes to continue

with the reset.
3. The Counter screen will now display zeroes in each "Count Since
Last Reset" column. The screen will continue to display the "Total
Count" for this analyzer.

4. Press Print to generate a copy of the counts.

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ABL80 FLEX Operator's Manual 8. Utilities

Settings transfer

Introduction This procedure provides a simple and rapid method for setting up multiple
analyzers with the same settings.
The analyzer can copy the settings for a particular analyzer to an external storage
device. The storage device can then be used to copy this setting information to any
other ABL80 FLEX analyzer of the same version.
The same version is defined here as two (or more) ABL80 FLEX analyzers with
FLEX software configuration, two (or more) ABL80 FLEX analyzers with BASIC
software configuration, two (or more) ABL80 FLEX CO-OX analyzers with CO-
OX software configuration, or two (or more) ABL80 FLEX CO-OX analyzers with
OSM software configuration.
The transfer of settings between analyzer versions is limited to the Data
Communications and Security settings.

Transfer to disk Follow the steps below to transfer analyzer settings to an external storage device.
Step Action
1. Select Menu  Utilities  Settings Transfer  To Disk.
2. Connect a storage device to one of the two USB ports at the rear of the
analyzer.
3. Press OK to store all settings onto the storage device.

Transfer from Once a settings transfer file has been created, follow the steps below to transfer
disk analyzer settings into an analyzer.
Step Action
1. Select Menu  Utilities  Settings Transfer  From Disk.

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8. Utilities ABL80 FLEX Operator's Manual

2. Select the settings to transfer into this analyzer.

The available settings on the Settings/Setup tab are:
• Settings
– Patient
– Manual QC
– System Cycle (2 Point Cal in the BASIC configuration)
– Security
– tHb Cal (ABL80 FLEX CO-OX analyzer only)
• Setup
– Date/Time
– Units
– Data Communications
– System Status
– Correlation
– Record Deletion
– Main Menu Setup
The available settings on the Reports/System tab are:
• Reports
– Input Fields
– Printout
– Download Patient Setup
• System
– Active Parameters
– Air Detection
– QA Portal
– Database Maintenance
3. Once all settings have been selected on the first two tabs, press the
Transfer tab.
4. Connect the storage device, containing the desired settings, to either of
the analyzer USB ports.
5. Press OK. The requested settings will be copied into this analyzer.

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ABL80 FLEX Operator's Manual 8. Utilities

tHb calibration
Introduction The ABL80 FLEX CO-OX analyzer requires a manual calibration of the
spectrometer on a periodic basis. Please refer to Chapter 5, Calibration for
instructions on the calibration of the ABL80 FLEX CO-OX spectrometer.

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8. Utilities ABL80 FLEX Operator's Manual

Rinse

Introduction The rinse function allows the user to initiate an additional flush of solution through
the sensor cassette. A rinse may be performed at any time and as frequently as
desired.

Rinse procedure Follow the steps below to initiate a rinse.

Step Action
1. Select Menu  Utilities  Rinse.
2. Press the Rinse button to initiate a single flush of solution 1.
3. ABL80 FLEX analyzer only: To
aid in removal of blood residue or
air bubbles, pull and release the
sensor cassette pump tubing
repeatedly while the analyzer is
flushing.

4. Repeat steps 2 and 3 as necessary.

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ABL80 FLEX Operator's Manual 8. Utilities

Software upgrade

Introduction Radiometer releases software upgrades periodically. To install this software

upgrade, complete the following steps.

Upgrade Follow the steps below to upgrade the analyzer’s application software.
procedure
Step Action
1. Select Menu  Utilities  Software Upgrade.
2. Insert the upgrade CD, provided by Radiometer, into the CD drive at
the front of the analyzer.
3. At the prompt, press OK to begin the upgrade process.
4. Follow all instructions on the screen to complete the upgrade process.

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8. Utilities ABL80 FLEX Operator's Manual

Eject CD

Introduction The analyzer contains an internal CD drive. This drive will automatically load a
CD that is introduced into the CD slot. To remove a CD, use this Eject CD feature.

Eject procedure Follow the steps below to remove a CD from the CD drive.
Step Action
1. Select Menu  Utilities  Eject CD.
2. The CD will be ejected from the drive. Grasp the CD and remove it
from the analyzer.

Manual eject If for any reason the eject procedure does not respond or is not available, a CD can
also be ejected manually. At the front of the CD drive there is a small hole in the
housing near the CD label. Inserting a small object, such as a paperclip, into this
hole will mechanically eject the CD.

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 9. Settings

Introduction The Settings section provides a means of customizing a variety of software

options.

In this chapter This chapter covers the following topics:

Patient ranges .........................................................................................9-2
Manual QC .............................................................................................9-7
Manual QC ranges..................................................................................9-8
Manual QC lockout ..............................................................................9-11
Manual QC statistical factor.................................................................9-13
Manual QC schedule ............................................................................9-14
Manual QC temperature .......................................................................9-17
RiliBÄK ranges ....................................................................................9-19
System Cycle schedule.........................................................................9-21
System Cycle drift ................................................................................9-22
Standby schedule..................................................................................9-23
tHb calibration schedule.......................................................................9-25
Date/time ..............................................................................................9-26
Units .....................................................................................................9-27
Data communications ...........................................................................9-29
FlexLink ...............................................................................................9-39
Analyzer message.................................................................................9-41
System status ........................................................................................9-42
Correlation ...........................................................................................9-44
Record deletion ....................................................................................9-48
Main menu setup ..................................................................................9-49
Reports .................................................................................................9-52
Reports – input fields ...........................................................................9-53
Reports – printout.................................................................................9-59
Reports – report options .......................................................................9-69
Reports – patient download..................................................................9-71
System – active parameters ..................................................................9-72
System – air detection ..........................................................................9-75
System – analyzer lockout ...................................................................9-77
Security ................................................................................................9-78
9. Settings ABL80 FLEX Operator's Manual

Patient ranges

Introduction All ABL80 FLEX analyzer versions allow the user to define up to six patient types,
each type with its own set of reference ranges and critical limits. In addition, the
user can define a reportable range for the analyzer, specific to their laboratory.
Patient analysis results within the defined reference range are considered “normal”
and are represented on reports without any additional symbols.
Patient analysis results that fall outside the defined reference range (but not yet
beyond the critical limits) are accompanied by a single up or down arrow. In
downloaded data, these values are marked with the letter H (high) or L (low).
Patient analysis results that fall beyond defined critical limits are accompanied by a
double up or down arrow. In downloaded data, these values are marked with the
letters HH (high) or LL (low).
A value beyond the test range of the analyzer is represented by a triple up or down
arrow. In downloaded data, these values are marked with the letters HHH (high) or
LLL) low. It is possible to set a critical limit beyond the test range. A value beyond
both the test range and the critical limit will only display a triple arrow.

Low Critical High Critical

Limit Limit

Reference Range

(Normal)

Test Range

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ABL80 FLEX Operator's Manual 9. Settings

Patient types Establishing patient types allows the user to define specific Reference Ranges and
Critical Limits for each patient type. Enabling Patient Types causes a selection
box to appear on the Sample Aspiration screen during analysis to select the
desired patient type for each analysis.
Follow the steps below to establish patient types.
Step Action
1. Select Menu  Settings  Patient.
2. The first tab is Patient Types.

3. Enable this feature by pressing the check box labeled Define Patient
Types.
4.
Enter up to six different patient types by pressing the icon and
using the keyboard provided.
5. When complete, press OK or select another tab to store these new
entries.

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9. Settings ABL80 FLEX Operator's Manual

Reference Follow the steps below to enter reference ranges for each sample type and patient
ranges type. Only sample types of arterial, venous, mixed venous and capillary are
available for establishing ranges. Sample types of "other" and "proficiency" are not
included in the available list of sample types.
Reference range values must fall within the test range of the analyzer and must be
within the critical limit boundaries established on the Critical Limits tab.
Step Action
1. Select Menu  Settings  Patient.
2. Select the Reference Ranges tab.

3. Select the desired Sample Type and Patient Type from the list boxes
provided.
4. Use the keypad provided to edit all desired upper and lower reference
range values.
5. When entries are complete, press OK or select another tab to store the
new values.

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ABL80 FLEX Operator's Manual 9. Settings

Critical limits Follow the steps below to enter critical limits for each sample type and patient
type. Only sample types of arterial, venous, mixed venous and capillary are
available for establishing ranges. Sample types of "other" and "proficiency" are not
included in the available list of sample types.
Critical limit values must fall within the measuring range of the analyzer and must
be outside the reference range limits established on the Reference Ranges tab.

Step Action
1. Select Menu  Settings  Patient.
2. Select the Critical Limits tab.

3. Select the desired Sample Type and Patient Type from the list boxes
provided.
4. Use the keypad provided to edit all desired upper and lower critical
limit values.
5. When entries are complete, press OK or select another tab to store the
new values.

Reportable The measuring range for a parameter is the range within which the analyzer is
range capable of measuring. The measuring range corresponds to the “range of indication”
as defined in the “International vocabulary of basic and general terms in metrology
(VIM)”. In all versions of the ABL80 FLEX analyzer, any measured result that falls
outside the measuring range is replaced with a triple asterisk sign (* * *).
The test range for a parameter is the range within which performance of the analyte
has been verified. The test range corresponds to the “measuring range” as defined
in the “International vocabulary of basic and general terms in metrology (VIM)”.
In all versions of the ABL80 FLEX analyzer, any value that falls outside the test
range (but not yet beyond the measuring range) is flagged with a triple arrow next
to the result.
All ABL80 FLEX analyzer versions have a predefined measuring range and test
range. The Reportable Range feature allows the user to establish a user-defined
reportable range, which can further limit the span of values reported. The user-

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9. Settings ABL80 FLEX Operator's Manual

defined reportable range must fall within the analyzer’s predefined measuring
range. When the user-defined reportable range is enabled and established, any
analysis result that falls outside the range is either flagged with an asterisk (*) or
replaced by the acronym R/R (reportable range).

Entering Follow the steps below to enter user-defined reportable ranges.

reportable
Step Action
ranges
1. Select Menu  Settings  Patient.
2. Select the tab labeled Reportable Ranges.

3. To enable this feature, press the Options list box and select either Flag
Results or Suppress Results.
• Flag Results: when selected, any patient sample result outside the
defined reportable range will be marked with an asterisk (*) next to
the value
• Suppress Results: when selected, any patient sample result outside
the defined reportable range will be replaced by the acronym R/R
4. Use the keypad provided to edit the upper and lower reportable range
values as desired.
5. Press OK when complete or select another tab to store these settings.

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ABL80 FLEX Operator's Manual 9. Settings

Manual QC

Introduction All ABL80 FLEX analyzer versions have the capability to perform manual quality
control measurements as an additional check of the system function if desired. The
Manual QC section of Settings provides a means to set up the following features:
• Enter range information, including lot number, expiration date, solution ID and
range limits for daily QC measurements
• Enable the QC lockout feature
• Adjust the statistical factor
• Establish a mandatory QC schedule
• Establish entry criteria for QC ampoule temperature
• Establish RiliBÄK range limits (optional feature)

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9. Settings ABL80 FLEX Operator's Manual

Manual QC ranges

Introduction The user can enter or view the lot number, solution ID, expiration date and QC
control range (acceptable range) for individual levels. During manual QC analysis,
the analyzer will compare the measured results with these defined ranges.
A result outside the control range is marked by a single up or down arrow.
A result beyond the statistical range limit (as defined by the statistical factor
described further in this chapter) is marked by a double up or down arrow.
In the QC download, the up or down arrows are replaced by the letters H (high)
and L (low). See Chapter 7, Data logs for more information on QC Download
files.

Statistically Acceptable Range Statistically

Unacceptable Unacceptable

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ABL80 FLEX Operator's Manual 9. Settings

QC ranges Follow the steps below to enter or view the QC range information.
Step Action
1. Select Menu  Settings  Manual QC  Ranges.

NOTE: The ABL80 FLEX CO-OX analyzer screen contains two

selections under Range. One is to view and enter range limits for all
blood gas, electrolyte and glucose parameters (labeled pH...). The
second is to view and enter range limits for all oximetry parameters
(labeled ctHb...). The ABL80 FLEX CO-OX analyzer screen does not
contain selections for Hct Level 1 and Hct Level 2.100011
2. Radiometer QUALICHECK4+, QUALICHECK5+ and
QUALICHECK Hematocrit/Metabolite control solution information
can be entered by scanning the barcode provided in the package insert.
Use the Scan button on this screen (or the optional external scanner) to
automatically enter the solution ID, Lot, Expiration date and Ranges
for each parameter.
All fields on this screen can also be manually modified by performing
the remainder of the steps in this procedure.
3. Verify the lot number for each level. Lot numbers can be edited by
selecting the keypad icon next to the desired lot field.
4. Select the appropriate solution ID from the list provided. The list
consists of the following choices:
• ABL80 FLEX analyzer: Solution IDs for QUALICHECK4+ (Level
1 - 4) and QUALICHECK Hematocrit/Metabolite (Hct Levels 1 and
2) control solutions
• ABL80 FLEX CO-OX analyzer: Solution IDs for
QUALICHECK5+ (Level 1 - 4) control solutions
• Other (for Range+ QUALICHECK or non-Radiometer solutions)
NOTE: Automatic level detection and temperature correction are not
available for non-Radiometer solutions

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9. Settings ABL80 FLEX Operator's Manual

5. • The expiration date field is enabled when a check mark appears in

the check box
• Once the expiration date field is enabled, verify or change the
expiration date using the date control.
6.
Press the Range button to review the upper and lower limits of
the acceptable ranges. To adjust these ranges, place the cursor in the
desired field then use the keypad provided to edit the value.
NOTE: In the ABL80 FLEX CO-OX analyzer there are two range
buttons. One provides input fields for all blood gas, electrolyte and
glucose parameters. The second provides input fields for all oximetry
parameters.

7. Press OK to store the range limits entered.

8. When all entries are complete, press OK.

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ABL80 FLEX Operator's Manual 9. Settings

Manual QC lockout

Introduction The QC lockout function automatically flags or suppresses any sample parameter
result that fails to meet acceptable QC criteria.
There are three levels of manager control for the lockout feature:
• Lockout – This selection activates the lockout feature. When activated, the
acronym “L/O” replaces the reported value for each selected parameter when
manual QC measurements for this parameter fall outside the control range.
• Warning – This selection works in conjunction with the System Status feature.
When activated, any parameter that falls outside the control range will prompt a
warning message and will cause the main menu status light and the affected
parameter in the parameter bar to turn yellow. In addition, a question mark will
appear next to a failed QC parameter on subsequent sample analysis results. This
feature can be used alone or in combination with the L/O feature. When used in
combination with L/O, the acronym “L/O” replaces the parameter result. The
question mark will not appear but the status light will be yellow.
• Disable Analysis – This selection works in conjunction with the System Status
feature. When activated, sample analysis is disabled when the corresponding
parameter fails to meet QC criteria. The main menu status light will display red.
This feature overrides the L/O and Warning features.
Once a parameter is locked out, this feature can only be cancelled by either of the
following two actions:
• Perform a successful QC analysis of the failed parameter and level
• Disable the QC lockout feature for that parameter

QC lockout Follow the steps below to activate the QC lockout feature.

ABL80 FLEX
Step Action
analyzer
1. Select Menu  Settings  Manual QC  Lockout.
2. Press the check box for each parameter to enable the warning, lockout,
or disable analysis choices as desired.
NOTE: A parameter can be chosen for both warning and lockout.
When disable analysis is selected, the warning and lockout selections
are disabled.
3. Press OK when complete to store the new settings.

QC lockout Follow the steps below to activate the QC lockout feature.

ABL80 FLEX
Step Action
CO-OX
analyzer 1. Select Menu  Settings  Manual QC  Lockout.
2. Select the desired tab. There is one tab each for Warning, Lockout
and Disable Analysis. Each tab contains a check box for every
parameter.

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9. Settings ABL80 FLEX Operator's Manual

3. Press the check box for each parameter to enable the warning, lockout,
or disable analysis choices as desired.
NOTE: A parameter can be chosen for both warning and lockout.
When disable analysis is selected, the warning and lockout selections
are disabled.
4. Press OK when complete to store the new settings.

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ABL80 FLEX Operator's Manual 9. Settings

Manual QC statistical factor

Introduction The user can define the statistical limit, beyond which QC results are excluded
from statistical calculations. This statistical factor applies only to manually run QC
samples.
A traditional laboratory control range is the mean ± 2SD (two standard deviations)
of the data points. This range should include 95.5 % of all measurement values.
A common laboratory statistical range is the mean ± 3SD. This range should
include 99.7 % of all measurement values.
The statistical factor in the analyzer is used to modify the acceptable QC control
range to determine the statistical range beyond which results will not be included
in statistical calculations. For instance, if the control range is 38-42, then
multiplying the span of 4 by 1.5 would result in a statistical range of 37-43.
The default statistical factor is 1.5 and expands a 2SD range to a 3SD range for the
purpose of identifying those values for inclusion in statistical calculations.

Statistical factor Follow the steps below to enter the desired statistical factor.
Step Action
1. Select Menu  Settings  Manual QC  Statistical Factor.
2. Use the keypad provided to modify the statistical factor as desired.
Valid input values are from 1.0 to 9.9.
3. Press OK when complete to store the new entry.

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9. Settings ABL80 FLEX Operator's Manual

Manual QC schedule

Introduction The QC schedule feature allows the user to establish a mandatory frequency of
manual quality control measurements. Once a QC schedule has been established,
the system will disable sample analysis if manual QC is past the time due. See
Settings  Setup  System status further in this chapter to establish a warning
period prior to the time of a required manual QC measurement.
The day of the week, time of day for the first measurement of the day, and interval
of time between measurements each day can be set for each level of quality
control. A manual QC measurement can also be required immediately following
the replacement of a sensor cassette or solution pack or following a parameter re-
activation.

QC schedule Follow the steps below to establish a manual QC schedule.

Step Action
1. Select Menu  Settings  / Manual QC  Schedule.
NOTE: The ABL80 FLEX CO-OX analyzer does not include
selections for Hct Level 1 and Hct Level 2.

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ABL80 FLEX Operator's Manual 9. Settings

2.
Press the edit button for the level desired.

3. Enter a Daily Start Time from the drop-down list. The available
choices are the top of each hour throughout a 24-hour period. The
time selected will be the first time of each day that QC will be
required. Subsequent required times during that same day depend on
the interval set.
4. Enter an Interval from the drop-down list. The available choices are
Never, 8, 12 and 24 hours. As an example, if the Daily Start Time is
set to 08:00 and the Interval is set to 8 hours then QC would be
required at 08:00, 16:00 and 24:00.
NOTE: An Interval of Never will inactivate the schedule feature for
that level.
5. Press the check box next to each day of the week desired (or Select
All).
NOTE: A Daily Start Time, Interval and Day of Week must all be
selected to set manual QC to mandatory for that level.
6. Press the check box next to the selections for mandatory QC following
sensor cassette or solution pack replacements and parameter re-
activation as desired.
7. Press OK to store the new entries.
8. Repeat for each level desired.

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9. Settings ABL80 FLEX Operator's Manual

9. The Manual QC Schedule screen will display a summary of all

settings for all levels.

10. Once all levels have been defined, press Close to exit the Manual QC
Schedule screen.

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ABL80 FLEX Operator's Manual 9. Settings

Manual QC temperature

Introduction Radiometer brand quality control materials have defined corrections for
temperature variations. The QC temperature feature allows the user to enter the
temperature to which the QC ampoule was equilibrated into the analyzer. The
analyzer will then correct the resulting measured value to a standard 25 °C value.
It is very important that the temperature entered be an accurate reflection of the
temperature of the ampoule. Ensure adequate temperature equilibration time has
occurred to ensure the quality control material has fully equilibrated to the storage
temperature.
This feature provides several options:
• A pop-up question box prior to each manual QC measurement prompting the
user for a QC ampoule temperature. This reminds the user to enter a value for
each measurement.
• A retain feature so any temperature value entered is retained for 30 minutes. This
allows for multiple measurements within a single run without the need to input
the temperature for each measurement.
• A default temperature value. If no default value is established then the entry
becomes mandatory. The analyzer must have a temperature value entered to
complete the measurement.
NOTE: The ABL80 FLEX CO-OX analyzer with OSM software configuration does
not require a manual QC temperature correction feature.

QC temperature Follow the steps below to activate the QC temperature feature and define the
desired settings.
Step Action
1. Select Menu  Settings  Manual QC  Temperature.

2. Press the check box labeled Ask before each analysis to enable a
question box to appear each time a manual QC is run. This will
prompt the user to enter a temperature value.

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3. Press the check box labeled Retain for 30 minutes to retain the last
temperature value entered for 30 minutes.
4. Using the radio button selection, press either
• None (Mandatory entry) to blank out the temperature value,
effectively making entry mandatory
• Temperature input field to enter a default temperature using the
keypad provided
5. Press OK when all entries are completed.

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RiliBÄK ranges

Enter RiliBÄK Follow the steps below to establish RiliBÄK ranges. For more information on
range limits using these ranges, see Chapter 6, Quality Management / RiliBÄK ranges.
NOTE: This feature must be enabled by your Radiometer service representative.
Step Action
1. Select Menu  Settings  Manual QC  RiliBÄK Ranges.

2. On the first tab of the RiliBÄK Ranges screen, place a check mark in
the check box to apply the established RiliBÄK ranges to manual QC
or to the automatic QC results from System Cycle results, as desired.
3. Select each of the remaining tabs to establish the desired span for each
parameter.
NOTE: The ABL80 FLEX CO-OX analyzer does not include a tab for
Hct; it does include tabs for the oximetry parameters.

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4. For each parameter the following selections are available:

• Type of factor – a drop-down box that provides either a “relative”
or an “absolute” factor. A relative factor means the Factor entered
is considered a percentage of the assigned QC value. An absolute
factor means the Factor entered is an actual value in that parameter
unit.
• Factor – the value used by the system to calculate the RiliBÄK
range span. For instance, if the factor is defined as “relative” and is
a value of 10 then the system will multiply 10% times the QC
assigned value then add and subtract that value from the assigned
value to determine the RiliBÄK range. As an example, if the QC
assigned value is 40 then the range would be:
Span: 40 x 10% = 4
Upper limit: 40 + 4 = 44
Lower limit: 40 – 4 = 36
The new RiliBÄK range would be 36 – 44
• Valid Range – each parameter reportable range can be divided into
segments. Each segment can then have a unique factor applied.
• Add – a button at the bottom of the screen allows the user to add
multiple lines to a single parameter. This allows the creation of
multiple segments for one parameter across the reportable range.
Once there are at least two lines, a button with a negative sign (-)
will appear at the end of each line to delete each line as desired.
5. When all selections are complete, press OK.

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System Cycle schedule

Introduction The System Cycle schedule allows the user to select the frequency of automatic
System Cycles. The available selections are every 2, 4 or 8 hours. The
recommended frequency is every 8 hours.
The ABL80 FLEX CO-OX analyzer with OSM software configuration offers
System Cycle frequencies of 2, 4, 8, 12 and 24 hours. The recommended frequency
is every 24 hours.
When a non-QC3 sensor cassette is installed or when using an ABL80 FLEX
analyzer with the BASIC software configuration, this selection controls the
frequency of two-point calibrations.

Schedule Follow the steps below to set the System Cycle schedule.
Step Action
1. Select Menu  Settings  System Cycle  Schedule.
2. Press the drop-down box to view the possible selections (2, 4 or 8
hours).
3. Highlight the desired selection.
4. Press OK.

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System Cycle drift

Introduction The System Cycle drift setup screen allows the user to enable the reporting of drift
values for those values that are outside acceptance criteria for each parameter.
These values are displayed on the System Cycle results screen.
When the System Cycle drift feature is enabled, the System Cycle download file
will include columns to report these out of range drift values.
When a non-QC3 sensor cassette is installed or when using an ABL80 FLEX
analyzer with the BASIC software configuration, this option is not available.

Schedule Follow the steps below to enable System Cycle drift reporting.
Step Action
1. Select Menu  Settings  System Cycle  Drift.
2. Press the check box to Enable System Cycle drift values.
3. Press OK to store this selection.

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Standby schedule

Introduction The Standby Schedule screen is available only on ABL80 FLEX analyzers with
the BASIC software configuration or ABL80 FLEX CO-OX analyzers with the
OSM software configuration. This screen allows the user to pre-schedule standby
events. The screen contains two tabs. One tab allows a standby event to be
scheduled for a specific date and time. The second tab allows a standby event to be
scheduled on a recurring basis for a particular day of the week and time of day.
See a further description of this feature in Chapter 5, Calibration.

Schedule by Follow the steps below to define a standby schedule for a particular date and time.
date
Step Action
1. Select Menu  Settings  Two Point Calibration  Standby.

2. On the Date/Time tab, enable this feature by pressing the check box
labeled Enable.
3. Highlight each day, month and year field under Enter Standby then
use the up and down arrows to adjust accordingly until the desired
date is displayed. Adjust the time in the same manner.
4. Repeat for the Exit Standby date and time.
5. When all entries have been made, press OK to store this schedule.

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Schedule by day Follow the steps below to define a standby schedule for specific days of the week.
of week
Step Action
1. Select Menu  Settings  Two Point Calibration  Standby.
2. Select the Day of Week tab.

3. On the Day of Week tab, enable this feature by pressing the check
box labeled Enable.
4. Using the drop-down box provided, select the desired day of the week.
There is also a choice for All Days which will activate the standby
feature every day at the time designated.
5. Highlight the hour and, using the up and down arrows, adjust the hour
as desired. Repeat this process for the minutes.
6. Highlight the Duration field then use the up and down arrows to
adjust as desired. The system will automatically calculate and display
the scheduled exit time based on the information entered.
• The maximum duration entry is 167 hours (one hour less than 7
days) for any one day of the week
• The maximum duration entry is 23 hours when the All Days
selection is chosen for Start Day
7. Use the Add button to add additional lines. Each line is numbered for
easy identification. The system will allow up to seven lines.
8.
Use the button to remove a line as desired. The first line cannot
be removed.
9. When all entries have been made, press OK to store this schedule.

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tHb calibration schedule

Introduction The tHb calibration schedule setup screen is available on the ABL80 FLEX CO-
OX analyzer only. This screen allows the user to establish the date of the next tHb
calibration and establish an interval between mandatory calibrations.
An interval of zero will disable mandatory tHb calibrations.

Schedule Follow the steps below to establish a tHb calibration schedule.

Step Action
1. Select Menu  Settings  tHb Calibration  Schedule.
2. To adjust the Next scheduled calibration, highlight the day, month
and year fields then use the up and down arrows to adjust the values to
the desired date.

3. To modify the Interval, use the on-screen keypad. The allowable

input values are 0 – 180 days.
The recommended interval is 90 days. A selection of 0 effectively
disables this feature.
4. When all selections are complete, press OK.

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Date/time

Introduction The analyzer provides a screen for the user to modify the date and time in the
analyzer.

WARNING Ensure both the date and the time is correct in the analyzer prior to installation of
the solution pack. An inaccurate date and time will affect calibration values,
leading to potentially inaccurate sample results.

CAUTION: Resetting the analyzer date back by at least one full day will cause the system to set
the installation status of both consumables to un-installed. The sensor cassette will
need to be re-installed. The solution pack will no longer be able to be used.

Set date/time Follow the steps below to modify the current date and time.
Step Action
1. Select Menu  Settings  Setup  Date/Time.
2. There are two tabs, one for the date and a second tab for the time.
3. Select the Date tab to make the following selection:
• Highlight the day, month or year, then use the up or down arrow to
adjust the value. Holding down the arrow will cause the values to
change rapidly.
• Press the drop-down list labeled Format to select the desired format
to display the date. Available formats include:
– M/d/yyyy
– M/d/yy
– MM/dd/yy
– MM/dd/yyyy
– yy/MM/dd
– yyyy-MM-dd
– dd-MMM-yy
• An example of each selection is displayed in the upper left corner of
the tab.
4. Select the Time tab to make the following selections:
• Highlight the desired hour, minute, second, or am/pm field then use
the up or down arrow to adjust the value. Holding down the arrow
will cause the values to change rapidly.
• Press the drop-down list labeled Format to select the desired format
to display the time
• An example of each selection is displayed in the upper left corner of
the tab.
5. Press OK.

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Units

Introduction The analyzer provides a variety of unit choices for measured, derived, and input
parameters.
The following table lists the available unit choices in all ABL80 FLEX analyzer
versions. The first column under Available units is the default setting.
Parameter Available units
pCO2 mmHg kPa
pO2 mmHg kPa
+
cNa mmol/L meq/L
+
cK mmol/L meq/L
cCa2+ mmol/L meq/L mg/dL
cCl- mmol/L meq/L
cGlu mmol/L mg/dL
cLac mmol/L meq/L mg/dL
ctHb mmol/L g/dL g/L
ctO2 Vol% mmol/L mL/dL
ctCO2 mmol/L Vol% mL/dL
Temperature Centigrade Fahrenheit
Derived Parameters mmol/L meq/L
Barometric Pressure mmHg kPa
Weight lbs kg
Height inches cm m
Birth Weight g kg oz

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ABL80 FLEX The ABL80 FLEX CO-OX analyzer provides the following additional unit
CO-OX selections. The first column under Available units is the default setting.
analyzer
Parameter Available units
Oximetry % Fraction
Hct % Fraction
BO2 Vol% mmol/L mL/dL
· mL/min mmol/min
D O2
· mL/min mmol/min
VO2
FShunt % Fraction
RI % Fraction
pO2(a/A) % Fraction
FO2(I) % Fraction

Select units Follow the steps below to select the desired units for each parameter.
Step Action
1. Select Menu  Settings  Setup  Units.
2. Select the desired units for each category from the drop-down lists. In
the ABL80 FLEX CO-OX analyzer, navigate through the various tabs
to locate all desired fields.
3. Press OK when all entries are complete.

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Data communications

Introduction All ABL80 FLEX analyzer versions are capable of communicating to external
network systems using a variety of data transfer protocols. The Data
Communications screen provides a means to configure these settings. The screen
contains the following tabs:
• Network Settings – to enter settings information such as the computer name and
network address
• RADIANCE/AQURE – to enable communication with the Radiometer
RADIANCE/AQURE data management system
• HIS/LIS – to enable communication with a hospital or laboratory information
system. This screen provides the necessary connection specifications
• Data Request – to set up the features desired for patient data query to a network
• QA Portal – to enable a connection with the Radiometer QA Portal
• Remote Support – to enable a connection allowing external control of the
analyzer, for use by Radiometer service personnel
• Approval – to enable the approval of results prior to transmission to an HIS/LIS
system

Network settings Follow the steps below to enter the specific names and network address for the
analyzer.
Step Action
1. Select Menu  Settings  Setup  Data Communications.
2. The screen will open to the Network Settings tab.

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3. The first two fields can be edited using the keyboard button to the
right of the fields. These fields include:
• Analyzer Name – a user-defined name for this analyzer up to 20
characters. This name will be sent when communicating within the
network. This name also appears on analysis printouts. The default
name is the serial number of the analyzer. The purpose of this field
is to provide a more user-friendly name for the analyzer that can be
readily identified.
• Computer Name – the network identified name for the analyzer’s
computer
4. The next two options include radio buttons and three text fields. These
fields include:
• Radio buttons to select between two selections – Obtain an IP
address via DHCP and Specify an IP address
• Three text fields that are enabled only when the radio button is set
to Specify an IP address. Each field has its own numeric keypad to
enter data. These fields include
 IP address
 Subnet mask
 Default gateway
5. The final fields include radio buttons and two text fields. These fields
include:
• Radio buttons to select between two selections – Obtain DNS server
IP automatically and Use the following DNS server IPs
• Two text fields used to manually enter DNS server IPs. These fields
include
 Primary DNS
 Secondary DNS
6. Proceed to another tab as desired or press OK to store all entries.
7. When any selections, other than Analyzer Name, are changed on this
tab and OK is pressed, the analyzer will require current connections be
closed and the analyzer be re-booted for these changes to take effect.

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RADIANCE/ The RADIANCE/AQURE tab can be used to enable a connection to the

AQURE RADIANCE/AQURE data management system.
Follow the steps below to enter the necessary connection specification information.
Step Action
1. Select the Radiance tab on the Data Communications screen.

2. Press the check box to Enable the RADIANCE/AQURE

communication option.
3. To enter a unique password for RADIANCE/AQURE
communication:
• Press the keyboard button next to the Password field
• Enter the desired password
• Press OK
4. To enter the TCP/IP address:
• Press the keyboard button next to the TCP/IP Address or Host field
• Enter the desired information
• Press OK
5. To enter the port number:
• Press the keyboard button next to the TCP/IP Port Number field
• Enter the desired information
• Press OK

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6. Select the desired time, in seconds, to wait between attempts to

reconnect when the network connection is lost. The available choices
are:
• 15
• 30
• 60
• 120
• 180
• 240
• 300
7. Select the amount of time, in minutes, to allow the system to wait
prior to timing out.
• ABL80 FLEX analyzer: The available choices are 15, 30 and 60
seconds and 3 - 15 minutes.
• ABL80 FLEX CO-OX analyzer: The available choices are 0.25, 0.5
and 1-15 minutes.
8. Select the maximum number of times the system will try to retransmit
a packet of information that was previously unsuccessful. The
available choices are 0 - 3 tries.
9. The encoding for the RADIANCE/AQURE system is displayed on
this tab and is ISO-8859-1.
10. When all desired selections have been made, press OK to close the
screen and store the information.
• A message box will appear that states:
Changing communications settings will close all current
connections and may take several seconds. Are you sure you
want to continue?
• Press Yes to continue or No to return to the Data Communications
screen.

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HIS/LIS The HIS/LIS tab can be used to enable and establish an unlimited number of
connection types. Follow the steps below to enter the necessary connection
specification information.
Step Action
1. Select the HIS/LIS tab on the Data Communications screen.

2. To enable a connection, press the check box labeled Enable in the

upper left corner.
3. Each connection can be assigned a user-defined name. This name can
be entered in the text field labeled Connection Name located in the
upper right corner. The default name is HIS/LIS. The name entered
will become the label on the tab.
4. Select the high level protocol and low level protocol using the drop-
down lists.
5. Select the desired encoding from the list provided. This list is country
specific, based on the language selected.
6. Press Settings to select the various settings for the low-level protocol
selected. When all settings have been made, press OK.

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7. The specifications available will depend on the low level protocol

selected.
a. The selections for a Serial low-level protocol include:
• Baud Rate – selections include 300, 1200, 2400, 4800, 9600,
14400, 19200 and 38400
• Data Bits – selections include 5, 6, 7 and 8
• Stop Bits – selections include 1, 1.5 and 2
• Parity – selections include None, Odd, Even, Mark and
Space
• Radio buttons to select between two different transmission
formats which include:
 Use ETX in all records (ASTM Standard)
 Use ETB in all records except the last (Radiometer
Classic)
b. The selections for a TCP/IP low-level protocol include:
• Address or host name – alphanumeric entry
• Port number – a numeric entry
• Reconnect interval – selections of 15, 30, 60, 120, 180, 240
and 300 seconds. It specifies how often to attempt to
reconnect to a network when the connection is lost.
• Timeout – the amount of time the analyzer will wait for an
acknowledgement from the network. Selections include 15,
30 and 60 seconds and 3-15 minutes for the ABL80 FLEX
analyzer and 0.25, 0.5, and 1-15 minutes for the ABL80
FLEX CO-OX analyzer.
• Max. retransmissions – the maximum number of times the
analyzer will attempt to retransmit the same packet of
information to the network
• Msg start character – a list of possible start characters for
each message
• Msg end character – a list of possible end characters for
each message
8. Within the group box for Transmissions is a check box to enable the
transmission of edit information. Press the check box to enable this
feature if desired.

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9. Also within the group box for Transmissions is a set of check boxes to
set specific types of records for automatic transmission. The different
record types are:
• Patient
• Manual QC
• System Cycle (not available with BASIC software configuration)
• 2 Pt. Cal
• tHb cal (ABL80 FLEX CO-OX analyzer only)
NOTE: If data transmission is temporarily lost, the system will
automatically synchronize all data once the transmission is re-
established.
10. There is a button labeled Add Channel at the bottom left of the screen
to add additional HIS/LIS channels as desired. When pressed the
system will add an additional tab to establish another HIS/LIS
connection.
Once a second HIS/LIS tab is created, there will also be a button
labeled Remove Channel to delete the additional tab as desired.
11. When all settings are entered, press OK or select another tab.

Data request The Data Request tab allows the user to configure the query options. Follow the
steps below to select the desired settings.
Step Action
1. Select the Data Request tab on the Data Communications screen.

2. Using the drop-down box, select the desired communication

connection for information queries. The selections will depend on the
connection types defined by the user on the RADIANCE/AQURE
and HIS/LIS tabs.
3. Patient information can be queried based on the Patient ID, Accession
Number and Department (Patient). Press the associated check boxes to
enable this feature.

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4. When all settings are entered, press OK or select another tab.

QA Portal The QA Portal tab allows the user to enable and configure a connection to the
Radiometer QA Portal. Follow the steps below to select the desired settings.
Step Action
1. Select the QA Portal tab on the Data Communications screen.

2. To enable automatic uploading of WDC data to the QA Portal, check

the Enable check box.
3. To establish a connection to the QA Portal, use the keyboard button to
enter the TCP/IP Address or host. Manual upload of WDC data to the
QA Portal only requires entry of the TCP/IP address. It is not
necessary to check Enable.
4. Modify the following selections as desired:
• Port number – a numeric entry
• Reconnect interval – selections of 15, 30, 60, 120, 180, 240 and
300 seconds. It specifies how often to attempt to reconnect to a
network when the connection is lost.
• Timeout – the amount of time the analyzer will wait for an
acknowledgement from the network. Selections include 15, 30
and 60 seconds and 3-15 minutes for the ABL80 FLEX analyzer
and 0.25, 0.5 and 1-15 minutes for the ABL80 FLEX CO-OX
analyzer.
• Max. retransmissions – the maximum number of times the
analyzer will attempt to retransmit the same packet of information
to the network
5. When all selections are complete, press OK or select another tab.

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Remote support The Remote Support tab allows the user to log onto the analyzer from a remote
location. This is an optional feature that must be installed separately. Please contact
your Radiometer representative to have this feature installed.
Remote support can assist the user by allowing Radiometer service representatives
to troubleshoot analyzer issues remotely. It utilizes NetOp® (Danware Data A/S)
to provide external access and control of the analyzer screens.
Follow the steps below to open a communication portal and enable this feature.
Step Action
1. Select the Remote Support tab on the Data Communications screen.

2. Press the check box labeled Enable Remote Support to enable this
feature.
3. Press OK or select another tab.

Approval The Approval tab allows the user to enable the approval of patient results prior to
uploading those results to an HIS/LIS system. Follow the steps below to enable the
approval feature.
When enabled, an approval button will appear on the patient results screen. This
button allows the user to set a status for each sample of either approved, rejected or
rerun. Only approved samples are uploaded to HIS/LIS systems.
It is also possible to approve or reject a sample from the RADIANCE/AQURE data
management screen.
NOTE: Once a status has been selected, the sample result can no longer be edited.

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Step Action
1. Select the Approval tab on the Data Communications screen.

2. Press the check box labeled Enable Result Approval to enable this
feature.
3. Press OK or select another tab.

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FlexLink

Introduction The FlexLink setup screen contains two tabs, allowing the user to enable the
FlexLink feature, define any optional sample age limitations and define the
contents of the sample pre-registration screen.

Logistics The Logistics tab allows the user to enable the FlexLink feature and define sample
age limitations.
NOTE: A RADIANCE/AQURE connection must be configured prior to enabling
FlexLink.
NOTE: Sample age information received from the RADIANCE/AQURE FlexLink
transmission will override the age settings entered into the analyzer.
Follow the steps below to enable FlexLink.
Step Action
1. Select Menu  Settings  Setup  FlexLink.

2. Press the check box labeled Enable FlexLink to enable this feature.
3. Press the check box labeled Enable calculation of sample age to
enable this feature. Once enabled, use the keypad button next to each
parameter to enter the desired sample age. The allowable input range
is 1-100 minutes.
NOTE: The ABL80 FLEX CO-OX analyzer will include selections for
all oximetry parameters in addition to the ones listed above
(excluding Hct).
NOTE: The ABL80 FLEX analyzer with BASIC software
configuration does not include cGlu as shown above.
4. Press OK or select another tab.

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Pre-registration The Pre-registration tab allows the user to select the field on which to base the
query for patient information. It also allows the user to define the contents of the
sample pre-registration screen as seen during sample analysis.
Follow the steps below to configure the pre-registration screen.
Step Action
1. Select the Pre-registration tab on the FlexLink screen.

2. Select the field (Sampler ID or Accession number) on which to base

the FlexLink query to the RADIANCE/AQURE system by pressing
the desired radio button.
3. Press the various check boxes to enable or disable the desired fields to
be included in the sample pre-registration screen.
4. Press OK or select another tab.

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Analyzer message

Introduction Analyzer Message allows the user to enter a message that will then appear on the
main menu.
When connected to the RADIANCE/AQURE system, this message will also
appear on the RADIANCE/AQURE system. A message can also be entered in the
RADIANCE/AQURE system which will then display on the analyzer’s main
menu.
Follow the steps below to enter an analyzer message.
Step Action
1. Select Menu  Settings  Setup  Analyzer Message.

2. Using the keyboard provided, enter any message up to 100 characters.

3. Press OK.
4. The message will now display on the main menu.

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System status

Introduction This setup screen allows the user to set the threshold value that turns the main
menu traffic light from green to yellow. A yellow light signifies that the analyzer is
currently ready for sample analysis but warns the user that some impending action
must be taken soon to continue this analyzer’s availability for sample analysis.
NOTE: A selection of 0 (zero) effectively disables this warning feature. A selection
of zero is only available under Manual QC, Data Files, Data Maintenance and
CO-OX as listed below.
The possible selections are:
• Sensor cassette
Time before cassette expires (hours): 1-96 hours
Tests remaining on the cassette: 1-150 tests
• Solution pack
Time before pack expires (hours): 1-96 hours
Cycles remaining for solution 1: 1-100 cycles
Cycles remaining for solution 2: 1-100 cycles
Cycles remaining for solution 3: 1-100 cycles
Cycles remaining for solution 4: 1-100 cycles
• Manual QC
Time before QC lot expires (days): 0-60 days
Time before QC is required (minutes): 1-480 minutes
• Data Files
Number of patient records remaining: 0-100
Number of System Cycle records remaining: 0-100
Number of 2 Point Cal records remaining: 0-100
Number of manual QC records remaining: 0-100
Number of event records remaining: 0-500
Number of security records remaining: 0-500
• Data Maintenance
Time before data maintenance is performed: 0-96 hours
• CO-OX (ABL80 FLEX CO-OX analyzer only)
Time before tHb calibration is due: 0-7 days

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System status Follow the steps below to enter the desired traffic light threshold values.
Step Action
1. Select Menu  Settings  Setup  System Status.
2. Press the desired tab to enter the necessary threshold values, using the
keypad provided.
3. Press OK when all entries are complete.
NOTE: A manual QC measurement performed during the “Time
before QC is required” (warning period) will satisfy the upcoming
required QC event. If performed prior to the warning period, a QC
measurement will still be required at the previously scheduled time.

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Correlation

Introduction This setup screen allows the user to mathematically adjust the analytical results of
the analyzer based on results from a reference analyzer or reference material. The
correlation coefficients can be specified for slope and offset (y-intercept) for each
measured parameter.
Establishing correlation values requires a carefully performed comparison study
between the ABL80 FLEX analyzer (any version) and the reference analyzer. A
significant number of samples (at least 30) spanning the entire reportable range is
necessary to provide reliable statistical results. The data from the ABL80 FLEX
analyzer should be treated as the independent variable (x) and the data from the
reference analyzer should be treated as the dependent variable (y).
The basic formula for this relationship is:
y = mx + b
Where
y = reference analyzer
m = slope
x = ABL80 FLEX result
b = offset

Correlation The software provides three different modes for applying correlation values
modes
The Blood mode applies any entered correlation values to patient samples
identified as arterial, venous, mixed venous or capillary.
The Hemodilution mode applies a correlation value to the Hct result only and
overrides any Hct correction entered in the Blood mode. It is meant to correct the
measured value for variations seen during high hemodilution states, such as during
cardiopulmonary bypass.
The Other Fluids mode applies any entered correlation values to any patient
samples identified as “other fluids”.

Default values The default values for slope and offset in all modes are 1.00 and 0.0 respectively.
Only by entering values other than 1.00 and 0.0 is the correlation feature enabled
for each parameter.
These correlation values do not affect manual QC measurements.

Units of The values entered for the offset value should be entered in the unit of measure for
measure each parameter as selected under the Units setup screen.

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Input range The following table lists the range of acceptable input values for the blood mode.
blood mode
Parameter Slope (m) Offset (b)
pH 0.80–1.20 ±0.05
pCO2 0.80–1.20 ±10 mmHg
pO2 0.80–1.20 ±20 mmHg
cNa+ 0.80–1.20 ±10 mmol/L
cK+ 0.80–1.20 ±1.0 mmol/L
cCa2+ 0.80–1.20 ±1.00 mmol/L
cCl- 0.80–1.20 ±10 mmol/L
cGlu 0.75–1.25 ±5 mmol/L
cLac 0.75–1.25 ±5 mmol/L
Hct 0.50–1.50 ±15%
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%

Input range The hemodilution correlation mode is applied to patient samples that are
hemodilution hemodiluted, as during heart surgery when a patient is placed on cardiopulmonary
mode bypass.
During periods of high hemodilution, the protein levels in the blood are reduced,
and hematocrit measurements based on conductivity methods may be biased when
compared to results from a non-conductivity based reference method. The use of
the hemodilution correlation mode allows the ABL80 FLEX hematocrit
measurement to be adjusted to correlate with another reference method.
The following table lists the range of acceptable input values for the Hemodilution
mode for the ABL80 FLEX analyzer only.
Parameter Slope (m) Offset (b)
Hct 0.10–10.00 ±10%

Input range The other fluids correlation mode is for use with samples other than human whole
other fluids blood.
mode
CAUTION: The testing of other fluids (urine, pleural fluid, dialysate, etc.) has not
been characterized or validated with the ABL80 FLEX analyzer (all versions).
Therefore, validation and performance characteristics for fluids other than
heparinized human whole blood are the responsibility of the operator. Data used
for establishing the operator-defined correction must cover the desired measuring
range and include evaluation of the linearity.

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The following table lists the range of acceptable input values for the other fluids
mode. The sample is assumed to be something other than whole blood and
therefore hematocrit and oximetry parameters are omitted.
Parameter Slope (m) Offset (b)
pH 0.10–10.00 ±1.00
pCO2 0.10–10.00 ±30 mmHg
pO2 0.10–10.00 ±50 mmHg
cNa+ 0.10– 10.00 ±100 mmol/L
cK+ 0.10–10.00 ±10.0 mmol/L
cCa2+ 0.10–10.00 ±10.00 mmol/L
cCl- 0.10–10.00 ±100 mmol/L
cGlu 0.10–10.00 ±30 mmol/L
cLac 0.10–10.00 ±30 mmol/L

Enter blood Follow the steps below to enter the desired correlation values.
correlation
Step Action
values
1. Select Menu  Settings  Setup  Correlation.
2. On the Blood tab, place the cursor in the desired field. Using the
keypad provided, enter the desired value.
3. Press OK when complete, or select another tab.

Enter Follow the steps below to enter the desired correlation values. This tab is available
hemodilution only in the ABL80 FLEX analyzer.
correlation
Step Action
values
1. Select Menu  Settings  Setup  Correlation.
2. Press the Hemodilution tab.

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3. Place the cursor in the desired field. Using the keypad provided, enter
the desired slope and offset values. When a value other than 1.00 and
0 is entered, a check box will appear on the sample aspiration screen
to enable/disable this feature for each sample analysis.
4. Press the desired radio button selection to choose from the three
options available:
• Apply correlation factor –the hemodilution correlation factor will be
enabled by default for sample analysis. This setting can be disabled
on the aspiration screen as desired
• Do not apply factor –the hemodilution correlation factor will be
disabled by default for sample analysis. This setting can be enabled
on the aspiration screen as desired.
• Ask before each analysis – selecting this option will cause a
question box to appear each time Analysis is selected. The user
must answer the question "Do you want to apply the hemodilution
correlation factor (Hct)?" before proceeding to the aspiration screen.
5. Press OK when complete, or select another tab.

Enter other Follow the steps below to enter the desired correlation values.
fluids
Step Action
correlation
values 1. Select Menu  Settings  Setup  Correlation.
2. Press the Other Fluids tab.
3. Place the cursor in the desired field. Using the keypad provided, enter
the desired slope and offset values.
NOTE: These values will only be applied to sample results that are
identified as a sample type of Other.
4. Press OK when complete, or select another tab.

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Record deletion

Introduction The user can select the deletion method for patient and manual QC records when
the number of records reaches maximum capacity. The two choices are to
automatically delete the oldest record or to disable patient analysis or manual QC
analysis, as applicable, when the maximum record number is reached. The
maximum allowable quantity for each log is 500 records.
All other record types (i.e. System Cycle, Two-point Cal, tHb Calibration, SC
Check, Events, System Checks and Security) are automatically deleted once the
maximum number of records is saved. Prior to these records reaching maximum
capacity, they must be manually downloaded and deleted to prevent losing the
oldest records. See Chapter 7, Data logs / Download for more information on
downloading and deleting records.

Record deletion Follow the steps below to enter the desired record deletion selections.
setup
Step Action
1. Select Menu  Settings  Setup  Record Deletion.
2. Select the desired setting for patient results from the radio button
choices:
• Auto delete the oldest record – when the database log file is at
maximum capacity, the analyzer will automatically delete the oldest
patient record in order to store a new record. The user is not notified
of this deletion.
• Disable Analysis until patient records are deleted – when the
database log file is at maximum capacity, the analyzer will disable
the Analysis feature until the log file is deleted. See the Download
feature in Chapter 7 to delete records.
NOTE: The user can choose to be warned with a yellow traffic light
that records are reaching maximum capacity. See System status
earlier in this chapter.
3. Select the desired setting for Manual QC results from the radio button
choices:
• Auto delete the oldest record – when the database log file is at
maximum capacity, the analyzer will automatically delete the oldest
manual QC record in order to store a new record. The user is not
notified of this deletion.
• Disable Manual QC until QC records are deleted - when the
database log file is at maximum capacity, the analyzer will disable
the Manual QC feature until the log file is deleted. See the
Download feature in Chapter 7 to delete records.
NOTE: The user can choose to be warned with a yellow traffic light
that records are reaching maximum capacity. See System status
earlier in this chapter.
4. Press OK when all selections are completed.

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Main menu setup

Introduction The Main Menu Setup screen provides the user with two options to customize the
main menu. One option activates a simplified main menu which provides a single,
large Analysis button on the main menu screen. The second option activates a user-
defined list of icons (Quick Keys) to navigate directly to the associated screen.

Simplified main Follow the steps below to enable a simplified main menu.
menu
Step Action
1. Select Menu  Settings  Setup  Main Menu Setup.

2. On the Simplified Main Menu tab press the check box next to
Enable a simplified main menu to activate this feature.

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3. When enabled, the main menu will appear as shown here:

NOTE: In the ABL80 FLEX analyzer with FLEX software and the
ABL80 FLEX CO-OX analyzer with CO-OX software, enabling a
simplified main menu will automatically disable any quick keys that
have been selected.

Quick Keys Follow the steps below to select and activate quick keys.
Step Action
1. Select Menu  Settings  Setup  Main Menu Setup.
2. Select the Quick Keys tab.

3. Select all desired quick keys from the list of Available Quick Keys
on the left of the screen. When selected, the small check box next to
each icon will contain a check mark.
4. Press the right arrow button to add these selections to the list of Quick
Keys.

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5. To rearrange the order of the chosen quick keys:

• Press the quick key to be moved; the icon will darken to identify it
as selected
• Use the up or down arrow buttons to the right of the list to move the
selected quick key up or down in the list
6. To remove a quick key from the chosen list:
• Press all quick keys to be removed; the small check box next to
each icon will contain a check mark to show it has been selected
• Use the left arrow (between the Quick Keys list and the Available
Quick Keys) to remove the marked selections from the list
7. Once all desired selections have been made, press OK. The main
menu will now contain a column of quick key selections. When
pressed, the software will navigate directly to the desired quick key
screen.

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Reports

Introduction The reports section includes the following screens.

Input Fields allows the user to configure which fields to report. It also allows the
user to configure each field as mandatory if desired and allows the input to be
retained.
Printout allows the user to configure the printout for sample analysis and manual
QC. This screen is only available in software versions < v3.00.
Report Options allows the user to configure the patient report layout both on the
screen and printout as well as configure other printout options. This screen is only
available in software versions ≥ v3.00.
Download Patient Setup allows the user to limit which input and derived values
to include in a patient download file.

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Reports – input fields

Introduction The setup screen includes several tabs. These tabs allow the user to select which
patient and sample information fields to enable during sample analysis. Another
tab includes default settings for sample type (all analyzer versions), a default
hemoglobin (ctHb(d)) value (all analyzer versions), and a setting to enable
oximetry range suppression and to apply a fetal hemoglobin correction (the ABL80
FLEX CO-OX analyzer only). The last tab provides the option to define parameter
panels for use during sample measurement.
All possible input fields for sample analysis can be enabled, marked as a
mandatory input and retained.

The analyzer will display a mandatory symbol next to any field designated as
mandatory. The user will not be allowed to complete sample analysis and view
results until data is entered in this field.
Enabling the retain feature for any field will cause the last entry to be retained.
Accession number and draw time do not have a retain option.

Input fields – The available input fields for sample analysis on the Patient Information tab for
Patient all analyzer versions include:
information tab
Input Parameter Description
Accession number 12 character text
Patient ID 20 character text
Last name 15 character text
First name 15 character text
Date of birth Date control field
Gender Male, female and unknown
Room number 10 character text
Department (patient) 20 character text
Department 20 character text
Weight 0-500 kg (0- 1100 lbs)
Height 0-3 meters (0-300 cm) (0-118 inches)
Gestational age 0-99 weeks
Birth weight 0.00-20.00 kg (0-20000 g) (0.0-705.5 oz)

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Input fields – The available input fields for sample analysis on the Sample Information tab for
Sample all analyzer versions include:
information tab
Input Parameter Description
Sample site List selection of right/left radial, right/left brachial,
right/left femoral, arterial line, PA catheter, umbilical
cord, right/left finger, right/left heel, scalp, bypass pump
and other
NOTE: An alternate list is available for the ABL80 FLEX
CO-OX analyzer with OSM software configuration. This
alternate list is designed for use in the cardiac
catheterization lab. Contact your local Radiometer
representative for details.
Draw time Date/time control field
Drawn by 20 character text; defaults to the user logged into the
analyzer
Order date Date control field
Physician 20 character text
Patient temperature 12.0-45.0 °C (53.6-113.0 °F)
FO2(I) Fraction of inspired oxygen; 0-100 %
Liter flow Select from values between 0.0-2.0, 3-15, and Flush
Baro Barometric pressure; 540-800 mmHg (72.0-106.7 kPa)
sO2(m) Measured oxygen saturation result from another analyzer;
0.0-100.0 %
ctHb(m) Measured hemoglobin result from another analyzer; 1.0-
28.0 g/dL (10-280 g/L)
Note 100 character text

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The Measured Information tab only appears on the ABL80 FLEX CO-OX
analyzer. The available input fields for sample analysis on the Measured
Information tab include:
Input Parameter Description

pO2(v– ) Mixed venous pO2 value

0-760 mmHg
0.0-101.3 kPa

sO2(v– ) Mixed venous oxygen saturation value

0.0 - 100.0 %
FCOHb(1) The fraction of carboxyhemoglobin measured before the
carbon monoxide injection (used in V(B) calculation)
0.0-100.0%
FCOHb(2) The fraction of carboxyhemoglobin measured after the
carbon monoxide injection (used in V(B) calculation)
0.0-100.0%
· Oxygen consumption
VO2
0-xxxx mL/min
0.0-xxx.x mmol/min
· Cardiac output
Qt
0.0 – 1000.0 L/min
VCO Volume of carbon monoxide (used in V(B) calculation)
0.0-1000.0 mL

Input fields Follow the steps below to enable the desired input fields. Enabled fields will be
setup available for entry each time a sample analysis is performed.
Any enabled field can be designated as mandatory. A mandatory field will require
a valid entry prior to the display of results for that analysis.
Most enabled fields can be designated as a retained field. This causes the last entry
to be retained on subsequent samples, until that information is modified.
NOTE: It is possible to designate a field as both mandatory and retained. This
selection may negate the intended purpose in some cases.

Step Action
1. Select Menu  Settings  Reports  Input Fields.
2. On the Patient Information tab, select the desired Enable,
Mandatory and Retain features for each field.
3. Press the Sample Information tab. Select the desired Enable,
Mandatory and Retain features for each field.

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4. ABL80 FLEX CO-OX analyzer only: Press the Measured

Information tab. Select the desired Enable, Mandatory and Retain
features for each field.
5. Press the Defaults tab.
6. Select the default sample type using the drop-down list. The available
choices are Arterial, Venous, Capillary, Mixed Venous, Other fluids
and Proficiency.
7. Enter a default hemoglobin value by placing the cursor in the numeric
field. Then use the keypad provided to enter the desired value.
NOTE: The default hemoglobin value is used for some calculated
parameters only when a measured hemoglobin value is not available,
a calculated hemoglobin value from the measured hematocrit is not
available and there was no measured value entered manually.
8. Select the fetal hemoglobin (HbF) correction type (ABL80 FLEX CO-
OX analyzer only) as desired. The three choices are
• None – no correction will be applied
• Enable for all levels – a correction will be applied for all samples
• Enable for >20% - a correction will be applied for all samples with
a FHbF value greater than 20%
9. Press the check box to add or remove a check enabling Oximetry out
of range suppression. This selection is only available on the ABL80
FLEX CO-OX analyzer. When enabled, a negative oximetry value
will be truncated to 0.0% and a value above 100.0% will be truncated
to 100.0%.
10. Press the Parameter Panel tab.

11. A check mark next to Enable Parameter Panels enables this feature. If
at least one parameter panel is then defined, the sample aspiration
screen will display the parameter panel choices entered on this screen.

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12. A check mark next to Retain Last Parameter Panel causes the
parameter panel used during the last sample measurement to be the
parameter panel chosen automatically for the next sample
measurement. The user then has the option of changing this selection
in the sample aspiration screen.
13.
• To add a new parameter panel, press the button.

• To remove an existing parameter panel, press the button.

• To edit an existing parameter panel, press the button.

• The up and down arrows rearrange the order of the parameter
panels. The order listed here is the order the parameter panels will
appear in the drop-down box on the sample aspiration screen.
14. Adding or editing a parameter panel opens an input window to enter
the desired information.

15.
Press the button to input the desired Panel Name and Order
Code.

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16.
Press the button to select the desired parameters for this panel.

• Parameters that are available for reporting have a green border.

Selecting one of these parameters causes a green check mark to
appear in the box.
• Parameters that are inactive for all cassettes have a gray border.
These parameters can be selected but will have a red check mark in
the box. This parameter will not be reported unless the user
modifies the status of this parameter on the Active Parameters
screen.
17. Select the desired Sample Type from the drop-down list of choices.
18. When all selections on all tabs are complete, press OK.

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Reports – printout

Printout setup
The Printout setup screen allows the user to customize the printout to include only
the information fields desired. This screen is only available in software versions
< v3.00.

The Printout screen includes several different tabs of data.

• Patient Information – input fields specific to the patient
• Sample Information – input fields specific to the sample
• Measured Information – input fields specific to derived parameters for the
ABL80 FLEX CO-OX analyzer only
• Derived Parameters – all available derived parameters
• Oximetry Derived Parameters – all available derived parameters unique to the
ABL80 FLEX CO-OX oximetry parameters
• Options – automatic printing and format options for various printouts
• Header – five lines of text to customize the header of the report printout
• Labels – to select between two sets of derived parameter labels

Screen access To access the Printout screen select Menu  Settings  Reports  Printout.

Patient The fields available to print on the Patient Information tab can be reviewed in the
information tab following screen:

Continued on next page

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Reports – printout, Continued

Sample The fields available to print on the Sample Information tab can be reviewed in the
information tab following screen:

Measured The fields available to print on the Measured Information tab can be reviewed in
information tab the following screen. This tab is only available in the ABL80 FLEX CO-OX
analyzer.

Continued on next page

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Reports – printout, Continued

Derived values The fields available to print on the Derived Parameters tab can be reviewed in the
tab following screen:

NOTE: In the ABL80 FLEX CO-OX analyzer the derived parameter sO2 displayed
here is replaced by pO2(a)/FO2(I).
NOTE: In the ABL80 FLEX CO-OX analyzer with OSM software configuration the
ctO2 derived parameter reflects only the oxygen bound to hemoglobin. The
calculation contains no contribution from the oxygen dissolved in plasma.
NOTE: In ABL80 FLEX analyzers with BASIC software configuration the derived
parameter mOsm is not available.
NOTE: Some measured and derived values have related temperature corrected
values. When “Temp corrected” is enabled and a patient temperature is entered,
temperature-corrected values will also be reported. Temperature corrected values
are denoted by an italicized letter "T".

Continued on next page

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Reports – printout, Continued

Oximetry The fields available to print on the Oximetry Derived Parameters tab can be
derived values reviewed in the following screen (ABL80 FLEX CO-OX analyzer only):
tab

Oximetry Several of the derived parameters for oximetry require input parameters to
derived values complete the calculation. The following table lists the required input parameters
required input

Derived Parameter Required input field

DO2 ·
Qt
· ·
Qt VO2
· ·
VO2 Qt
V(B) VCO, FCOHb(1), FCOHb(2)

Continued on next page

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Reports – printout, Continued

Derived values The following table describes the available derived parameters:
table Derived parameter Description
ctHb Total hemoglobin; 1.0-28.0 g/dL
cHCO3-(P) Plasma bicarbonate concentration; 0.0–
99.0 mmol/L
cHCO3-(P,st) Plasma bicarbonate in standardized
(can also be labeled SBC) blood; 0.0–99.0 mmol/L
cBase(B) Base excess in blood; ±50.0 mmol/L
(can also be labeled ABE)
cBase(Ecf) Base excess in extracellular fluid; ±30.0
(can also be labeled SBE) mmol/L
cBase(B,ox) Base excess in fully oxygenated blood;
±50.0 mmol/L
cBase(Ecf,ox) Base excess in extracellular fluid of
fully oxygenated blood; ±30.0 mmol/L
ctCO2(B) Carbon dioxide concentration in blood;
0.0–99.0 mmol/L
ctCO2(P) Carbon dioxide concentration in
plasma; 0.0–99.0 mmol/L
cCa2+(7.4) Ionized calcium concentration in
plasma corrected to a pH of 7.40; 0.20–
8.10 mmol/L
Anion Gap(K+) Concentration difference of major blood
anions and cations; 0.0–99.0 mmol/L
Anion Gap Concentration difference of major blood
anions and cations, excluding K+; 0.0–
99.0 mmol/L
sO2 Measured oxygen saturation; 0.0–100.0
%
ctO2 Total oxygen content; 0.0–45.0 vol %
pO2(A) Partial pressure of oxygen in alveolar
air; 0-800 mmHg
pO2(A-a) Partial pressure difference of oxygen
between the alveolar air and arterial
blood; 0-800 mmHg
pO2(a/A) Ratio of oxygen tension between the
arterial blood and the alveolar air; 0.00-
1.00
RI Respiratory index pO2(A-a)/ pO2(a/A);
0.0-35.0 %

Continued on next page

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Reports – printout, Continued

Derived values Derived parameter Description

table pO2(A,T) Temperature corrected partial pressure
of oxygen in alveolar air
(continued)
pO2(A-a,T) Temperature corrected partial pressure
difference of oxygen between the
alveolar air and arterial blood
pO2(a/A,T) Temperature corrected ratio of oxygen
tension between the arterial blood and
the alveolar air
RI(T) Temperature corrected respiratory index
mOsm Osmolality; 0–495 mmol/kg
(not available with the BASIC
software configuration of the ABL80
FLEX analyzer or with the OSM
software configuration of the ABL80
FLEX CO-OX analyzer)

Continued on next page

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Reports – printout, Continued

Derived values The following table described the additional derived parameters available in the
table – ABL80 ABL80 FLEX CO-OX analyzer:
FLEX CO-OX Derived parameter Description
p50 Partial pressure of oxygen at 50%
saturation
0-760 mmHg (0.0-103.3 kPa)
p50(T) Partial pressure of oxygen at 50%
saturation corrected to the patient’s
temperature
0-760 mmHg (0.0-103.3kPa)
p50(st) Partial pressure of oxygen at 50%
saturation in blood at standard
conditions of:
pH = 7.40
pCO2 =5.33 kPa
FCOHb and FMetHb set to 0
0-760 mmHg (0.0-103.3 kPa)
FShunt Relative physiological shunt
0.0-100.0%
FShunt Relative physiological shunt corrected
to the patient’s temperature
0.0-100.0%
pO2(a)/FO2(I) Ratio of arterial oxygen tension to
inspired oxygen level
pO2(x) Oxygen extraction tension of arterial
blood. Reflects the integrated effects of
changes in the arterial partial pressure,
content and p50 on the ability of arterial
blood to release O2 to the tissues
0-760 mmHg (0.0-103.3 kPa)
BO2 Hemoglobin oxygen capacity
· Oxygen delivery
D O2
· Cardiac output
Qt 0.0-1000.0 L/min
V·O2
Oxygen consumption
0-xxxx mL/min (0.0-xxx.x mmol/min)
Qx Cardiac oxygen compensation factor of
arterial blood defined as the factor by
which the cardiac output should
increase to allow release of 2.3 mmol/L
(5.1 mL/dL) oxygen at a mixed venous
pO2 of 5.0 kPa (38 mmHg)
V(B) Volume of blood
0.0-1000.0 L
Hct Hematocrit; this value is calculated in
the ABL80 FLEX CO-OX analyzer
from the measured ctHb
0-85%

Continued on next page

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Reports – printout, continued

Options tab Additional printout settings available on the Options tab can be reviewed in the
following screen:

NOTE: When Patient reports are enabled for Auto Print, a list box will display on
the Analysis aspiration screen to select the number of copies to print. If not
enabled, the list box on the aspiration screen will not appear.

Header tab The Header tab can be reviewed in the following screen. Each line allows for up to
25 characters.

Continued on next page

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Reports – printout, Continued

Labels tab The Labels tab allows the user to select between two different sets of parameter
labels for standard bicarbonate, actual base excess and standard base excess.

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Printout setup Follow the steps below to select the desired input and derived values to include in
the analyzer printout.
NOTE: Input fields that are enabled for printing but are left blank during an
individual sample analysis will not be printed.

Step Action
1. Select Menu  Settings  Reports  Printout.
2. On the Patient Information tab enable the desired fields to report.
3. Press the Sample Information tab then enable the desired fields to
report.
4. Press the Derived Parameters tab then enable the desired parameters
to report. In ABL80 FLEX CO-OX analyzers, also press the
Oximetry Derived Parameters tab to enable the desired parameters
to report.
NOTE: When Temp. corr. values is enabled and a patient
temperature is entered, any parameter selected for reporting will also
be reported with temperature correction as applicable.
5. Press the Options tab. Enable the desired selections as listed:
• Auto Print – Patient, System Cycle and Manual QC results can be
set individually to automatically print at the end of the event
• Reference ranges – will print reference ranges next to all measured
results on the patient results printout
• Manual QC ranges with each run – will print the acceptable QC
ranges with every manual QC result
• QC ranges with each System Cycle – will print the acceptable
ranges for the System Cycle quality control measured results
• Edit log – will print all edits performed on a particular patient
sample result will print at the bottom of the report printout
6. Press the Header tab. Use the keyboard button to the right of each line
to enter up to 25 characters per line. This information will appear at
the top of the printout.
7. Press the Labels tab. Select the desired derived values label option
from the two radio button selections. The two selections are:
• cHCO3-(P,st), cBase(B) and cBase(Ecf)
• SBC, ABE and SBE
8. When all selections are complete, press OK.

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Reports – report options

Introduction The report options screen allows users to customize the report layout for patient
sample results. The Report Options screen is only available in software versions
≥ v3.00.
The Report Options screen is organized into four different tabs
• Patient Layout – modify existing patient report layouts and create new
layouts
• Options – automatic printing and format options for various printouts
• Header – five lines of text to customize the header of the report printout
• Labels – to select between two sets of derived parameter labels
Patient Layout The following concepts apply to the list of layouts:
tab - Layouts • The Radiometer default patient report layout is listed as the first Layout
option and is labeled “-R- Default”. This default layout cannot be
modified.
• A copy of the –R- Default layout can be made by highlighting the –R-
Default layout then using the Copy Layout button to create a second copy.
This second copy can then be modified as desired.
• The name of each layout can be customized using the available keypad to
the right of the selected layout name.
• To create a new layout, use the New button
• To delete an existing layout, use the Delete button
• Select a layout then press the Set As Default button to set the selected
layout as the default for this analyzer
• Select a layout then press Print Preview at any time to generate an
example printout
• Select a layout then press Screen Preview at any time to generate an
example sample result as it would appear on the screen
Patient layout All items that are available for inclusion in the layout are listed on the left side of
tab – Edit the Edit screen. Because it is a long list, the user can use the drop-down list to limit
layout the displayed choices to just one of the pre-defined groups. Each group is color
coded as follows:

Group Color Description

Format gray For adding blank lines and defining a 2-column section
Header black • For adding section header names.
• “Headers” are centered on the report
• “Sub-headers” are left-justified
• Header text can be modified as desired using the
keyboard provided
Measured green For adding all available measured parameters
Group blue For adding pre-defined groups of measured parameters. As an
example, the Blood Gas group will provide pH, pCO2 and
pO2 to the report layout. This option is meant to minimize the
work in defining a layout
Derived red For adding all available derived parameters
Input orange For adding all available input parameters

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The following concepts apply when creating or modifying a layout:

• Select an item on the left then press the button to move it to the list of
report items on the right. The new item will always be added just above the
highlighted item currently on the right.
• Use the button to remove an item from the Items in Report list
• The label for any item in the Items in Report list can be modified by selecting
the item then using the keypad to edit the text.
• Items in the Items in Report list can be re-ordered using the up and down
arrow buttons
• Most items can be applied to the printout and screen separately, using the small
check boxes

Patient layout It is possible to design sections of a report layout using two columns. This two
tab – Edit column section is only available for displaying results on the screen, not on the
Layout - 2 printout.
column feature To design a two column section
• Select 2-Column Section Begin from the list of Available Items and
move it to the Items in Report
• This action will create three items
 2-Column Section Begin
 Column Break
 2-Column Section End
• Add all desired items into this section, before and after the column break to
define this two-column report section
• Select Screen Preview at any time to see an example of how this layout
will appear on the screen

Options tab See the section Reports – printout above for detailed information regarding the
Options tab function.
Header tab See the section Reports – printout above for detailed information regarding the
Header tab function.
See the section Reports – printout above for detailed information regarding the
Labels tab
Labels tab function.

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Reports – patient download

Introduction The user can select which input and derived parameters to include in the patient log
download file (see Chapter 7). This tab-delimited file will include, by default, a
column for every possible field. This can create a very large spreadsheet, with a
large number of blank columns. Selecting only those fields desired can make this
file easier to review and manipulate.
NOTE: During the download process, if the user chooses to delete all data after
the download, all data will be deleted, including fields of data not selected for
download.

Download setup Follow the steps below to select the desired fields to include in the patient log
download file.
Step Action
1. Select Menu  Settings  Reports  Download Patient Setup.
2. Review the information on each screen tab and enable those fields
desired.
3. Press OK when all selections are complete.

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System – active parameters

Introduction The user is allowed to enable or disable the measured parameters that are reported
during analysis.
The Active Parameters screen allows the user to inactivate a measured parameter
for the current sensor cassette only or for all cassettes (in-use now and into the
future). An inactivated parameter is not calibrated, quality control is not evaluated,
and it is not available for sample analysis. A parameter inactivated for all cassettes
will not appear on the main menu parameter bar
Once a parameter is inactivated, the user must manually re-activate it. The system
will require a successful System Cycle to complete the re-activation. When
inactivation of a parameter is selected for the current sensor cassette only, this
parameter will automatically be re-activated when a new sensor cassette is installed.

Auto-inactivate An option is also available on the Active Parameters screen that allows the user to
and re-activate inactivate a parameter at the time of a parameter failure, without navigating to this
screen. This is accomplished by asking the user whether or not they want to
inactivate parameter(s) at the time of failure. If this auto-inactivate feature is
enabled, it can be further configured with a timeout default answer to this question.
Setting the default to “Inactivate failed parameters” will cause the system to
automatically inactivate failed parameters but allow sample measurement to
continue (a green traffic light condition). It is also possible to configure the
analyzer to automatically re-activate a failed parameter if a subsequent System
Cycle is successful for that parameter. The default settings for these features are
the automatic inactivation and automatic re-activation of failed parameters.

Active Follow the steps below to activate/inactivate parameters in the ABL80 FLEX
parameters analyzer and select the default settings.
setup – ABL80
Step Action
FLEX analyzer
1. Select Menu  Settings  System  Active Parameters.

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2. In the "Current SC Only" section, ensure there is a check mark for

each desired parameter to activate that parameter for the currently
installed cassette only.
3. In the "All Cassettes" section, ensure there is a check mark for each
desired parameter to activate those parameters on all sensor cassettes
installed.
4. To change a setting, press the check box button. It will toggle from
checked to unchecked.
NOTE: pCO2 requires a pH value. When pH is inactivated, pCO2 will
be automatically inactivated as well.
NOTE: Hct requires a cNa+ value. When cNa+ is inactivated, Hct will
be automatically inactivated as well.
5. Select the Defaults tab.

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6. • To allow users to inactivate failed parameters during System

Cycles, calibrations or installations, ensure there is a check mark in
the box next to this selection.
– Select “Inactivate failed parameters” to set the default
response to the system question of inactivating a failed
parameter to “inactivate”. This will cause the System
Cycle, calibration or installation to be accepted by the
system and will allow for sample measurements without
reporting the inactivated parameter.
– Select “Do not inactivate...” to cause the System Cycle,
calibration or installation to fail thereby disabling sample
analysis.
• To allow the system to automatically re-activate an inactive
parameter, ensure there is a check mark in the box next to this
selection.
• To suppress patient results when the measurement is associated with
a system error, ensure there is a check mark in the box next to this
selection.
NOTE: Depending on security settings the system may require the
entry of a valid password to allow inactivation of a parameter at the
time of failure. See Security further in this chapter.
7. Press OK to store all entries.

Active The Active Parameters screen in the ABL80 FLEX CO-OX analyzer contains three
parameters tabs. The first tab includes a check box for each parameter in the sensor cassette
setup - ABL80 (SC80). (This first tab is not present in the OSM software configuration of the
FLEX CO-OX analyzer.)
analyzer
The second tab provides a check box for each oximetry parameter.
The third tab is identical to the Defaults tab in the ABL80 FLEX analyzer and is
used to configure the inactivation and reactivation default settings. On all tabs
there are check boxes to activate and inactive the various parameters.

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System – air detection

Introduction The user may disable air detection if desired. The user may also choose to discard
any patient sample results that the system identifies as having possible air in the
sample.

Auto-inactivate An option is also available on the Air Detection screen that allows the user to
inactivate the air detection feature at the time of an air detection system failure and
continue with the current measurement, without navigating to this setup screen.
This is accomplished by asking the user whether or not they want to inactivate air
detection at the time of failure. If this option is enabled then it can be further
configured with a timeout default answer to this question. Setting the default to
“Continue without Air Detection” will cause the system to automatically inactivate
air detection but allow sample measurement to continue (a green traffic light
condition).

Inactivate icon When the air detection system has been inactivated, an icon appears on the main
menu in the upper right corner alerting the user that the analyzer’s air detection
system is currently inactive.

Re-activate air Re-activation of the air detection system requires re-initialization of the sensor
detection cassette.

OSM software Air Detection is not available in the OSM software configuration of the ABL80
configuration FLEX CO-OX analyzer.

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Air Detection Follow the steps below to activate/inactivate air detection and select default
setup settings.
Step Action
1. Select Menu  Settings  System  Air Detection.
2. The factory default setting is to enable air detection. To disable air
detection, press the radio button labeled Inactivate Air Detection.
3. Press the check box labeled Allow users to continue without... to add
or remove the check mark, as desired. When enabled and air detection
fails, the user will be asked whether to continue sample measurements
without air detection. The factory default setting is to enable this
option.
When this question is not answered and the system times out, the
default response from the system can be selected using one of the two
radio buttons.
• Continue without Air Detection causes the system to continue to
allow sample analysis but without the air detection feature. The
disabled air detection icon will appear on the main menu.
• Do not continue without Air Detection... causes the system to
disable sample analysis.
4. When all selections have been made, press OK.

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System – analyzer lockout

Analyzer This screen allows the user to manually disable sample analysis or lockout
lockout individual parameters from being reported in patient sample measurement results.
In these situations, the locked parameter(s) continues to be calibrated and quality
control results analyzed.
When analysis is locked out, the main menu status light display is red and
accompanied by a message informing the user of the analysis lockout condition.
When one or more individual parameters are locked out, the main menu status light
display is yellow and accompanied by a message informing the user of the
parameter lockout condition. The parameter bar will display red for those
parameters that are locked out.
Follow the steps below to select the desired lockout settings.
Step Action
1. Select Menu  Settings  System  Analyzer Lockout.

2. Press the check box to enable the Analyzer Lockout feature. This will
disable sample analysis for all samples.
3. To disable single parameters only, press the check box to enable the
Parameter Lockout feature. Then press the desired parameter check
boxes to lock individual parameters. This will suppress results from
the checked parameters only.
NOTE: The ABL80 FLEX CO-OX analyzer’s Analyzer Lockout
screen includes all oximetry parameters as well as the parameters
shown above (excluding Hct).
4. Press OK when all entries are completed.

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Security
Introduction The security features allow a user to define access levels, establish a list of
authorized users, and control the method of analyzer logon.
Up to seven access levels can be defined by the user. Each access level can be
assigned a unique name. Each access level may include any combination of
permitted activities.
The system also pre-defines an eighth access level, labeled Administrator,
providing access to all areas of the software.
An authorized list of users can be established by the manager/administrator. Each
user can be assigned to one or more user-defined access levels. This option also
includes the ability to set an expiration date for each user.
The screen is divided into four tabs:
• Logon
• Users
• Groups
• Expirations

Automatic log Once a user is logged onto the analyzer, the system will automatically log this user
off off after two minutes of inactivity. The user also has the option to manually log off
the system using the Logoff button on the main menu.

Logon tab The Logon tab has four sections. The "Access Control Options" determines
whether or not passwords and usernames are entered. The "Password Control
Options" controls the period of time a password is valid and determines the
warning period prior to password expiration. The "Logon Policy Options" controls
whether or not logging onto the analyzer is mandatory. It also controls whether to
allow the username to be retained. The “Centralized User Management” feature
allows a RADIANCE/AQURE system to provide all user information and
permissions for users of the analyzer.

The Access Control Options to log on include:

• None – This selection provides unlimited access to all areas of the
software. A username and/or password are never requested. The Logon
button does not appear in the Menu list on the main menu.
• Logon Barcode only – This selection provides the option to log on using a
barcode only. When logged on, users have access only to those areas of the
software that their access allows.
• Password and Username – This selection provides the option of entering
a username and a password prior to navigating to select screens. The
username and password are entered by pressing the Logon selection from
the Menu list on the main menu. When logged on, users have access only
to those areas of the software that their access allows. Their username is
recorded in database logs for all events performed.

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The Password Control Options include:

• Validity (months) – This numeric value defines the time period that a password
is valid. Valid entries include 1-99 months.
Warning (days) – This numeric value defines the time period prior to password
expiration that the system will warn the users of their impending password
expiration. Valid entries include 1-99 days.
The Logon Policy Options include:
• Mandatory logon – when enabled, a user must enter a password or username
and password to be allowed access to any sections of the software
• Retain username – when enabled, the last username entered is retained in the
system. This can be useful when a single operator uses the analyzer repeatedly.
• Manual QC logon – when enabled, a user must enter a password prior to
performing a manual QC measurement
The Centralized User Management feature:
• Centralized user management allows a connected RADIANCE/AQURE system
to perform some of the management procedures usually performed on the
analyzer. The table shows which procedures will have to be performed on the
connected RADIANCE/AQURE system when this feature is enabled.

Procedures Performed on the Performed on the

RADIANCE/AQURE analyzer
system
Add new operator X
Select an access X
profile for a new
operator
Remove operators X
Select the logon X
procedure
Set up anonymous use X
of the analyzer
Edit an access profile X

NOTE: When centralized user management is enabled, all operator information in

the analyzer is overwritten by information received from the RADIANCE/AQURE
system. Conflicting information between the analyzer and the RADIANCE/AQURE
system can be seen in the Event log of the analyzer.

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Follow the steps below to select the desired Logon settings.

Step Action
1. Select Menu  Settings  Security.

2. On the Logon tab, press one of the three radio button selections for
Access Control Options.
NOTE: When “None” is selected, the Anonymous user must have
access to all areas of the software. See Users tab further in this
section for more information on the Anonymous user.
3. Press the keypad button next to the Password Control Options for
Validity to enter the desired number of months for a valid password.
Valid entries are from 1 to 99 months.
4. Press the keypad button next to the Password Control Options for
Warning to enter the desired number of days to warn prior to
password expiration. Valid entries are from 1 to 99 days.
5. Press any of the three check boxes to enable the Logon Policy
Options.
• Mandatory logon – when enabled a user must enter a Logon
Barcode or username and password to be allowed access to any
sections of the software
• Retain username – when enabled the last username entered is
retained in the system. This can be useful when a single operator
uses the analyzer repeatedly.
• Manual QC – when enabled a user must enter a password prior to
performing a manual QC measurement
6. Press the Centralized User Management check box as desired to
activate this feature.
7. Press OK or select another tab.

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Users tab The Users tab allows the manager to add or delete users as well as edit existing
users.
The username and password are mandatory. Each username must be unique.
Multiple users are allowed to have the same password. Any combination of letters
and numbers may be entered.
The Logon Barcode is an optional feature. When this feature is enabled, every
Logon Barcode must be unique for each user. The Logon Barcode and the
password may be the same if desired.
The system automatically defines two users, Administrator and Anonymous. The
default access permission for both users is full access.
The permitted activities of the Administrator user cannot be modified. The
username is "ADMIN" and cannot be edited. The default password is "admin". This
password can be edited by the manager/administrator.
NOTE: It is strongly encouraged that the manager selects a unique Administrator
password to fully utilize the security features.
The Anonymous user access can be modified. The Anonymous user is
automatically logged on whenever there is no other user logged onto the analyzer.
To limit general access under this condition, modify the permissions for the
Anonymous user. See the Groups tab in the next section to edit this user.
NOTE: If the system is configured with an Access Control Option of "None" then
the system forces the Anonymous user to have Administrator access. This is
necessary because the setting "None" does not provide a means to log onto the
analyzer.
NOTE: When Centralized User Management is enabled, the Add, Delete and Edit
buttons on the Users tab are disabled. The analyzer will continue to allow the
default users “Admin” and “Anonymous” to be edited.

Add a user Follow the steps below to add a new user and assign them to user groups.
Step Action
1. Select Menu  Settings  Security.
2. Press the Users tab.

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3.
Press the button to open the New User window.
4. Using the keyboard to the right of each field, enter the following
information:
• Username
• First name
• Last name
• Password
• Logon Barcode
• Department
5. Press the check box next to the desired Group Membership. The
access permissions for this group membership are defined on the
Groups tab. One user can belong to more than one group.
6. Press OK.

Remove a user Follow the steps below to remove a user.

Step Action
1. Select Menu  Settings  Security.
2. Press the Users tab.

3. Highlight the user to be deleted.

4.
Press the button to remove the selected user.
5. The system will ask if you are sure you want to delete this user.
• Press Yes to delete the user
• Press No to retain this user
6. When all entries are completed, select another tab or press OK to exit
this screen.

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Groups tab The Groups tab allows the manager to assign unique names to the eight
permission groups. The group access permissions can be chosen for each group.
This tab also allows a view of all members of a particular group.

Group names Follow the steps below to assign names to the various access groups.
Step Action
1. Select Menu  Settings  Security.
2. Press the Groups tab.

3. Select the desired group from the drop-down list in the Group Name
field.
4.
Press the keyboard button next to the Group Name field.
5. Enter the desired name and press OK.
6. Repeat for all group names desired.
NOTE: When Centralized User Management is enabled, group names cannot be
edited on the analyzer.

Group Follow the steps below to assign permissions to each defined group.
permissions
Step Action
1. Select Menu  Settings  Security.
2. Press the Groups tab.
3. Ensure the Group View field displays Permissions. If it does not,
select this choice from the drop-down list.
4. Highlight all Activities desired for the group displayed.
5.
Press the button to add these selections. When selected, a check
mark will appear next to the name.
6. Repeat for all group names desired.

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7. To delete a permission from a group, highlight that permission then

press the button. This will remove the check mark.
8. Press OK.
NOTE: When Centralized User Management is enabled, group permissions can
continue to be edited on the analyzer.
Group members To view a list of all users that belong to a particular group, perform the following
steps:
Step Action
1. Select Menu  Settings  Security.
2. Press the Groups tab.
3. Select Membership from the Group View drop-down list.

4. Select the desired Group Name.

5. All members of the group displayed will be listed on the screen.

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Expirations tab The Expirations tab allows the manager to reset either an individual user or all
user password expiration dates. The time period is controlled by the Validity
setting on the Logon tab.
Follow the steps below to reset user expiration dates.
Step Action
1. Select Menu  Settings  Security.
2. Press the Expirations tab.

3. From the Selection field select one of two choices:

• Any User – This selection allows one or more users to be
highlighted individually
• All Users – This selection automatically highlights all users
4. The date displayed next to the reset button is the new expiration
date that will take effect on all highlighted users once the reset button
is pressed. To change this date, select the Logon tab and modify the
Validity setting.
5. Press the button to reset the expiration date for the highlighted
users.
6. Press OK or select another tab.

NOTE: When Centralized User Management is enabled, all functionality on the

Expiration tab is disabled.

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 10. Troubleshooting
Overview

Introduction This chapter provides troubleshooting information for errors or messages that may
occur during the operation of all versions of the ABL80 FLEX analyzer.
Information that is unique to one analyzer version is clearly identified.

Contents This chapter contains the following topics.

General information........................................................................................10-2
Warnings and cautions .........................................................................10-3
Guidelines ............................................................................................10-4
Normal fluidics – ABL80 FLEX analyzer ...........................................10-5
Normal fluidics – ABL80 FLEX CO-OX analyzer .............................10-8
Analyzer cleaning and disinfection ....................................................10-10
Disinfection procedure .......................................................................10-12
System Cycle unsuccessful ............................................................................10-13
General information – sensor cassette................................................10-14
Single versus multiple parameters .....................................................10-15
Single parameter out of range – sensor cassette .................................10-20
Multiple parameters out of range – sensor cassette............................10-22
Possible sources of air contamination ................................................10-23
CO-oximeter troubleshooting.............................................................10-26
Manual QC results out of range...................................................................10-28
System messages ............................................................................................10-30
General error messages ......................................................................10-33
CO-OX error codes ............................................................................10-53
Result messages .................................................................................10-58
Battery management .....................................................................................10-62
10. Troubleshooting ABL80 FLEX Operator’s Manual

General information

Introduction This section provides information regarding cautions and warnings as well as
information on normal operation that can be fundamental to understanding error
conditions.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Warnings and cautions

Introduction This topic emphasizes important safety issues. Please review before proceeding
with any troubleshooting steps.

WARNING: Always shut down the analyzer and disconnect from AC power when cleaning and
disinfecting the analyzer.

WARNING: Always remember to exercise Universal Precautions when handling contaminants

and biohazardous materials (OSHA standard 1910.1030)

WARNING: Never use an analyzer that has a blocked waste drain. Using an analyzer with a
blocked waste drain may result in contact with biohazardous fluids.

WARNING: Follow legal requirements and local rules for safe work practices with chemicals.

CAUTION: Do not inject solution or air into the solution pack ports. Injecting solution or air
into the solution pack will alter the parameter values and may cause erroneous
measurements and/or failure messages.

CAUTION: Do not manually withdraw solutions from the solution pack ports. This action can
contaminate the solutions, altering the parameter values and may cause erroneous
measurements and/or failure messages.

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Guidelines

Introduction This topic describes guidelines pertinent to the use of the analyzers.

Guidelines The following guidelines are recommended for the ABL80 FLEX analyzer only
(the analyzer version without CO-oximetry):
• When installing a sensor cassette, ensure the cassette snaps onto the analyzer.
This will provide the proper electronic and fluidic connections.
• When installing a sensor cassette onto the analyzer, turn the roller wheel to
ensure free range of motion of the pump tubing

• During solution pump cycles,

while the roller wheel is
spinning, the cassette pump
tubing can be "snapped"
repeatedly to help dislodge any
air bubbles that might reside in
the cassette tubing and
measuring chamber.

The following guidelines are recommended for both the ABL80 FLEX and ABL80
FLEX CO-OX analyzers:
• Always shut down the analyzer using the Shutdown button on the main menu.
Turning the analyzer off directly by using the power switch at the rear of the
analyzer may cause file corruption.
• Ensure there is no storage device connected to either of the analyzer’s USB ports
whenever the analyzer is powered up. The connection of a storage device to a
USB port when the analyzer is powered up may prevent proper boot-up of the
system.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Normal fluidics – ABL80 FLEX analyzer

Introduction This topic describes aspects of the fluid transport system to help in understanding
and troubleshooting fluidic problems. The figure below identifies the components
of the fluidics system in the ABL80 FLEX analyzer (the version without CO-
oximetry).

Item Part Function

1 Inlet probe Pathway to introduce samples and flush system
solutions
2 Waste drain Collects fluids as they exit the inlet probe
3 Waste line Pathway for waste fluids
4 Flowcell Measurement chamber for samples

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Item Part Function

5 Roller wheel Activation of this wheel causes a peristaltic action
that transports samples into the flowcell and flushes
system solutions through the flowcell
6 Fluid port Point of entry of system solutions into the sensor
cassette flowcell
7 Side waste line Pathway for excess fluids during sample aspiration
8 Valve (V5) Allows or blocks passage of fluids to the side waste
line; maintains sample position during
measurement
9 Waste pump Transports waste fluids to the waste pouch in the
solution pack
10 V1-V4 Four valves that control which system solution is
drawn from the solution pack
11 Manifold Provides various fluid pathways to transport the
necessary solutions to the flowcell
12 Manifold luers These luers connect with the solution pack ports,
opening the solution pack pouch valves and
providing access to the pouch solutions
13 Solution pack Contains four solution pouches and one waste
pouch.
14 Solution pouch One of the four solution pouches (S1, S2, S3, S4)
15 Waste pouch The waste pouch within the solution pack. It
collects all waste, including calibration, QC and
sample solutions.

Sample When a sample is aspirated, the following steps occur:

introduction • The roller wheel actively pulls the sample through the inlet probe and into the
sensor cassette measuring chamber
• The system signals the user to remove the device from which the sample was
drawn and lower the inlet probe
• The roller wheel actively pulls the sample a second time, positioning it in place
for measurement. The leading edge of the blood sample should rest part way into
the pump tubing. The trailing edge of the blood sample should rest just outside
the view of the user to the left of the measuring chamber window.
• The system collects sensor readings, assesses stability criteria and records the
final readings on the blood sample

Sample flush Following measurement on the blood sample, the system performs the following
steps to flush the sample and complete the sample measurement process:

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

• The roller wheel flushes the blood sample down into the waste drain using
Solution 1 from the solution pack
• The system collects sensor readings, assesses stability criteria and records the
final readings on the flush solution

Final results Final results of the blood sample are calculated and reported, based on the results
of the blood sample readings and the flush readings.

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Normal fluidics – ABL80 FLEX CO-OX analyzer

Introduction This topic describes aspects of the fluid transport system to help in understanding
and troubleshooting fluidic problems. The figure below identifies the components
of the fluidics system in the ABL80 FLEX CO-OX analyzer.

Item Part Function

1 Inlet probe Pathway to introduce samples and flush system
solutions
2 Waste luer Connects to the waste port of the sensor cassette to
the analyzer’s waste line
3 Waste line Pathway for waste fluids
4 Flowcell Measurement chamber for blood gas, electrolyte
and glucose measurements

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Item Part Function

5 Fluid port Connection port between the sensor cassette
flowcell and the CO-oximeter
6 Pinch valve Closes the sample inlet line during oximetry
measurements
7 Hemolyzer Ultrasonically hemolyzes the sample in preparation
for oximetry measurements. The sample cuvette is
contained within the hemolyzer.
8 Liquid sensor Detects the presence of liquid at a specific point in
the fluidic pathway
9 Spectrometer Measures the absorbance spectra of hemoglobin
concentrations of the light transmitted through the
sample in the cuvette in the hemolyzer
10 Sample pump Activation of this wheel causes a peristaltic action
that transports samples into the flowcell and
hemolyzer and flushes system solutions through the
flowcell and hemolyzer
11 Valve (V5) Allows or blocks passage of fluids to the side waste
line; maintains sample position during
measurement
12 Waste pump Transports waste fluids to the waste pouch in the
solution pack
13 Valves (V1-V4) Four valves that control which system solution is
drawn from the solution pack
14 Manifold Provides various fluid pathways to transport the
necessary solutions to the flowcell and hemolyzer
15 Manifold luers These luers connect with the solution pack ports,
opening the solution pack pouch valves and
providing access to the pouch solutions
16 Solution pack Contains four solution pouches and one waste
pouch
17 Solution pouch One of four solution pouches (S1, S2, S3, S4)
18 Waste pouch The waste pouch within the solution pack. It
collects all waste, including calibration, QC and
sample solutions

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Analyzer cleaning and disinfection

Introduction Periodic cleaning and disinfection of the touch screen, inlet probe, waste drain and
the analyzer casing is recommended. Performing preventative maintenance during
solution pack and sensor cassette replacement is also recommended.

Disinfection Disinfection of outer surfaces is performed when appropriate. Disinfection

frequency depends on local requirements and the use of the instrument. Prior to
disinfection ensure that the analyzer surfaces are clean and without residue from
blood and/or liquids.
WARNING: Follow legal requirements and local rules for safe work practices
with chemicals.
WARNING: Always remember to exercise Universal Precautions when handling
contaminants and biohazardous materials (OSHA standard 1910.1030)

Cleaning the ABL80 FLEX analyzer only (the version without CO-oximetry): After each
inlet probe analysis, wipe the outside of the inlet probe with a tissue or gauze.
The outer surface of the ABL80 FLEX CO-OX analyzer’s inlet probe is wiped
automatically each time the inlet probe is lowered.
NOTE: In all analyzer versions, the internal pathway of the inlet probe is flushed
automatically after each analysis.

Cleaning the The analyzer casing can be cleaned, as needed, with a damp cloth.
analyzer casing WARNING: Always shut down the analyzer and disconnect from AC power when
cleaning and disinfecting the analyzer.

Disinfecting the The analyzer casing can be disinfected periodically using a dilute bleach solution
analyzer casing (1:9 ratio of sodium hypochlorite to deionized water) or other disinfecting agents
such as 70 % isopropyl alcohol, 70 % ethanol or 4 % Diversol BX solution. These
disinfecting agents may also be used in the analyzer areas noted below under
Cleaning during solution pack installation and Cleaning during sensor cassette
installation.

Cleaning the Use a clean, damp, non-abrasive cloth to clean the touch screen. Never allow
touch screen moisture to settle at the bottom of the screen. Any commercially available window
cleaner may also be used. All liquids should be first applied to a cloth. Never apply
liquids directly to the screen.
Long-term contact with abrasive materials will scratch the front surface, degrading
the image quality.
NOTE: Do not use bleach (sodium hypochlorite) products on the touch screen.

Disinfecting the An alcohol-based cleaner (e.g. 70 % isopropyl alcohol), followed by a water-

touch screen dampened cloth can be used periodically to disinfect the screen.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Cleaning during During the installation of a new solution pack, clean and dry the manifold in the
solution pack analyzer’s solution pack cavity. The luers can be cleaned with a damp, lint-free
installation cloth.

Cleaning during During the installation of a new sensor cassette, clean and dry the cassette nest and
sensor cassette waste drain area on the analyzer to remove any residue. The cassette nest and
installation opening to the waste drain can be cleaned with a lint-free cloth dampened with
water.

Disinfection of Blood and other biohazardous substances contact only limited areas of the analyzer
the waste drain system during normal use. These areas include the sensor cassette, waste drain,
waste tubing and the solution pack. The sensor cassette and solution pack can be
discarded in appropriate contaminated waste receptacles. The waste drain and
waste tubing can be disinfected by performing the following procedure.

WARNING: Never use an analyzer that has a blocked waste drain. Using an
analyzer with a blocked waste drain may result in contact with biohazardous
fluids.

WARNING: Always remember to exercise Universal Precautions when handling

contaminants and biohazardous materials (OSHA standard 1910.1030).

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Disinfection procedure

Disinfection Follow these steps to disinfect the waste drain and tubing of the ABL80 FLEX
procedure - analyzer (the version without a CO-oximeter).
ABL80 FLEX
analyzer only Step Action
1. At the main menu, remove the sensor cassette (if present) from the
analyzer.
2. Wipe any visible debris from in and around the waste drain using a
soft lint-free cloth moistened with cleaning solution (REF 943-906).
3. Ensure a solution pack is present in the analyzer. All waste solutions
will be collected in the waste pouch of this pack.
4. Draw up 1 mL of cleaning solution (REF 943-906) into a syringe.
5. Introduce this 1 mL of cleaning solution into the waste drain.
6. Allow the cleaning solution to remain in the waste drain for
approximately 1 minute.
7. Reconnect the sensor cassette to the analyzer, and wrap the pump
tubing around the roller wheel.
8. Select Menu  Utilities  Rinse. The rinse cycle will flush the
cleaning solution through the waste lines to the waste pouch inside the
solution pack.
9. Repeat steps 4-8 as desired.

NOTE: Never introduce any large cleaning implement down the ABL80 FLEX
waste drain. This may compact blood and protein deposits, producing
obstructions.
NOTE: Never wipe the sensor cassette pins or analyzer pin connection port with a
damp cloth.

Disinfection To clean and disinfect the ABL80 FLEX CO-OX analyzer as well as prepare it for
procedure - long-term storage, contact your Radiometer service representative.
ABL80 FLEX
CO-OX
analyzer only

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

System Cycle unsuccessful

Introduction This section provides detailed troubleshooting procedures in response to
unsuccessful System Cycle results. It includes information related to single
parameter failures and multiple parameter failures for sensor cassettes, including a
method for investigating possible air contamination. Where appropriate, it also
includes information specifically related to the ABL80 FLEX CO-OX analyzer.

ABL80 FLEX analyzers with the BASIC software configuration do not perform
System Cycles. However, the general troubleshooting concepts provided here are
applicable. Reproducible, single parameter failures during a two-point calibration
may indicate a sensor failure. Multiple parameter failures during a two-point
calibration usually indicate a system issue such as air contamination.
NOTE: Please see the section titled Failure Report in chapter 3 for information on
generating a failure report.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

General information – sensor cassette

Introduction The System Cycle and the installation process of a new sensor cassette are
fundamentally equivalent. The sensor cassette is exposed to all levels of solutions
and measurements are performed. When these measurements and resulting
calculations are performed, any parameter that is found outside acceptable limits is
flagged and the System Cycle or installation is considered unsuccessful.

As with any blood gas analyzer, unsuccessful calibration or QC can be due to

either a sensor function that is outside specifications or insufficient calibration
material in contact with sensors. It is unlikely to have more than one sensor
functioning outside specifications at the same time. Multiple parameter failures
typically indicate air in the sensor cassette measuring chamber.

Identification of Follow these steps to determine the parameters that are out of range.
failure
Step Action
1. Select Menu  Data  Logs  System Cycle.
2. Review the Status column of the last System Cycle (or two-point
calibration). This column will list all parameters that fell outside the
acceptable range.
• If all parameter results were successful, the Status will be "OK"
• If any parameter fell outside the acceptable range, it will be listed
here
• If the system identified the possibility that air is in one or more
solutions, the symbol "!!" will also be listed here
NOTE: This information is also available on the "Status" line of the
printout and on the General tab of the System Cycle Recall screen.
3. • If only one parameter is listed, proceed to Single parameter out of
range
• If more than one parameter is listed, and/or the air symbol is
present, proceed to Multiple parameters out of range

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Single versus multiple parameters

Introduction The first step in troubleshooting is to determine whether the failure is of one
parameter or whether there are two or more parameters that are out of range.
A secondary step is to determine whether the System Cycle results demonstrate the
failure to be during the calibration phase (sensitivity out of range) or the automatic
QC phase.

The System Cycle result printout, as well as the information on the analyzer
screen, will provide the necessary information to determine single versus multiple
parameters as well as whether the failure was during calibration or quality control.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

System Cycle The following is an example of a System Cycle printout with a single parameter
printout – single failure for calibration. Note that quality control results for the parameter with out-
parameter of-range calibration results are not calculated (N/C).
failure for
calibration
RADIOMETER ABL80 FLEX
SYSTEM CYCLE RESULTS

Analysis time: 6/16/2008 08:16:16

Type: Auto
SENSITIVITY VALUES

pH 51.6
CO2  24.3
O2 0.009
+
Na 61.5
+
K 56.8
2+
Ca 26.6
-
Cl 47.4
Glu 0.658
Hct 97.760

QUALITY CONTROL VALUES

Solution ID: C8001 C8002 C8003 C8004

Lot: 25048 24812 24551 24880
Cycles: 141 46 53 56

pH 7.36 7.04 7.67

pCO2 N/C N/C N/C
pO 2 150 67 233
cNa+ 152 103 167
cK+ 4.2 8.7 2.2
cCa2+ 1.16 2.30 0.48
cCl- 110 66 126
cGlu -0.2 16.3 4.1
Hct 3 70

MESSAGES
Status: pCO2

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

System Cycle The following is an example of a System Cycle printout with a single parameter
printout – single failure for a quality control result.
parameter
failure for
quality control RADIOMETER ABL80 FLEX
SYSTEM CYCLE RESULTS

Analysis time: 6/16/2008 08:16:16

Type: Auto
SENSITIVITY VALUES

pH 51.6
CO2 54.3
O2 0.009
Na+ 61.5
K+ 56.8
Ca2+ 26.6
Cl- 47.4
Glu 0.658
Hct 97.760

QUALITY CONTROL VALUES

Solution ID: C8001 C8002 C8003 C8004

Lot: 25048 24812 24551 24880
Cycles: 141 46 53 56

pH 7.36  7.04 7.67

pCO2 35 79 14
pO2 150 67 233
cNa+ 152 103 167
cK+ 4.2 8.7 2.2
cCa2+ 1.16 2.30 0.48
cCl- 110 66 126
cGlu -0.2 16.3 4.1
Hct 3 70

MESSAGES
Status: pH

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10. Troubleshooting ABL80 FLEX Operator’s Manual

System Cycle The following is an example of a System Cycle printout with multiple parameter
printout – failures for calibration. Note that quality control values for parameters with out-of-
multiple range calibration results are not calculated (N/C).
parameter
failure for
calibration RADIOMETER ABL80 FLEX
SYSTEM CYCLE RESULTS

Analysis time: 6/16/2008 08:16:16

Type: Auto
SENSITIVITY VALUES

pH  18.6
CO2  24.3
O2 0.009
Na+ 61.5
K+ 56.8
Ca2+  16.6
Cl- 47.4
Glu 0.658
Hct 98.070

QUALITY CONTROL VALUES

Solution ID: C8001 C8002 C8003 C8004

Lot: 25048 24812 24551 24880
Cycles: 141 46 53 56

pH N/C N/C N/C

pCO2 N/C N/C N/C
pO2 150 67 233
cNa+ 152 103 167
cK+ 4.2 8.7 2.2
cCa2+ N/C N/C N/C
cCl- 110 66 126
cGlu -0.2 16.3 4.1
Hct 3 70

MESSAGES
Status: pH, pCO2, cCa2+

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

System Cycle The following is an example of a System Cycle printout with multiple parameter
printout – failures for quality control results.
multiple
parameter
failure for RADIOMETER ABL80 FLEX
quality control
SYSTEM CYCLE RESULTS

Analysis time: 6/16/2008 08:16:16

Type: Auto
SENSITIVITY VALUES

pH 58.6
CO2 54.3
O2 0.009
Na+ 61.5
K+ 56.8
Ca2+ 26.6
Cl- 47.4
Glu 0.658
Hct 98.070

QUALITY CONTROL VALUES

Solution ID: C8001 C8002 C8003 C8004

Lot: 25048 24812 24551 24880
Cycles: 141 46 53 56

pH 7.36 7.04 7.67

pCO2 35  79 14
pO2 150  47 233
+
cNa 152 103 167
cK+ 4.2 8.7 2.2
cCa2+ 1.15 2.30 0.49
cCl- 110 66 126
cGlu -0.2 16.3 4.1
Hct 3 70

MESSAGES
Status: pH, pCO2, pO2

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Single parameter out of range – sensor cassette

Procedure If a single parameter is out of range following a System Cycle, perform the
following steps:
Step Action
1. Select Menu  Manual System Cycle to initiate a repeat System
Cycle.
2. ABL80 FLEX analyzer only (the
version without CO-oximetry):
During solution pump cycles,
while the roller wheel is spinning,
the cassette pump tubing can be
snapped repeatedly to help
dislodge any air bubbles that
might reside in the cassette tubing
and measuring chamber.

3. Review the Status of this repeat System Cycle. This information can
be found on the System Cycle printout or on the recall screen.
• If the same, single parameter continues to be out of range for
calibration or QC, use the System Cycle Troubleshooting table
below to determine the most appropriate troubleshooting steps. If
unsuccessful, it is also possible to inactivate the failed parameter
(see Chapter 9, Settings – Active parameters)
• If more than one parameter is out of range, especially for calibration
results (sensitivity), or a different single parameter is out of range,
proceed to Multiple parameters out of range

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Troubleshooting Refer to the following table when troubleshooting single parameter failures during
table a System Cycle. SC80 refers to the sensor cassette; SP refers to the solution pack.
This table applies to all versions of the ABL80 FLEX analyzer.
ABL80 FLEX Troubleshooting Guidance
Failure
Mode Step 1 Evaluate Step 2
Parameter (Same readings on
consecutive Step 1
System Cycles)
Replace SC80 Replace SP
Any type
pH (Sensitivity or QC
out-of-range)

Allow sensor Replace SC80

Sensitivity to re-hydrate
low (if time allows)
Replace SC80 Replace SP
Sensitivity
pCO2 high

Replace SC80 Replace SP

If Step 1 did not resolve issue, move to Step 2

QC out-of-
range

Replace SC80
Sensitivity
out-of-range
pO2 Replace SP Replace SC80
QC out-of-
range

Replace SC80 Replace SP

Electrolytes Any type
(Sensitivity or QC
cK+, cNa+, cCa++, cCl-
out-of-range)

1. Sensitivity Allow sensor Replace SC80

low to re-hydrate
(if time allows)
2. QC out-of-
range at
installation
Metabolites Replace SC80 Replace SP
cGlu, cLac Sensitivity
high

Replace SC80 Replace SP

QC out-of-
range during
use

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Multiple parameters out of range – sensor cassette

Procedure If more than one parameter is out of range following a System Cycle, perform the
following steps:
Step Action
1. Select Menu  Manual System Cycle to initiate a repeat System
Cycle.
2. ABL80 FLEX analyzer only (the
version without CO-oximetry):
During solution pump cycles,
while the roller wheel is spinning,
the cassette pump tubing can be
snapped repeatedly to help
dislodge any air bubbles that
might reside in the cassette tubing
and measuring chamber.
The system will display a picture
and instructional text reminding
the user to perform this step.
3. Review the Status of this repeat System Cycle. This information can
be found on the System Cycle printout or on the recall screen. If this
repeat event was unsuccessful, proceed to Possible sources of air
contamination.
NOTE: Air contamination is the most likely cause of multiple
parameter failures.
NOTE: Multiple parameter failures may also be due to reference gel
that has migrated into the cassette flowcell. If all attempts to identify
air contamination are unsuccessful, this may suggest the presence of
gel in the flowcell. In this instance, replacement of the sensor cassette
may be the proper corrective action.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Possible sources of air contamination

Introduction Investigation of the possible sources of air contamination includes examination of

all areas where the fluidic system can be opened such as the connection between
the analyzer and sensor cassette and the analyzer and the solution pack.

The possible sources of air contamination in the ABL80 FLEX analyzer are
illustrated in the following diagram. The possible sources of air in an ABL80
FLEX CO-OX analyzer are very similar. The sources, from top to bottom in the
diagram include:
1. Flowcell of the sensor cassette – This air can be introduced from a past
sample or be lodged in this area from a prior solution flush
2. Cassette fluid port – An incomplete seal between the fluid port and the
analyzer luer can introduce air into the fluidic system
3. Internal lines and valves – Internal tubing lines and valves can become
disconnected or blocked
4. Solution pack – The connection between the solution pack and the
analyzer can be a source of air contamination. Insufficient solution volume
in any of the solution pack pouches can also result in air contamination.

Sensor cassette Follow these steps to ensure proper connection of the sensor cassette to the
connection – analyzer in the ABL80 FLEX analyzer only:
ABL80 FLEX
Step Action
analyzer
1. Ensure the sensor cassette is fully snapped onto the front of the
analyzer.
• Remove the cassette from the analyzer
• While the cassette is off, examine the pins on the back of the
cassette. There should be no corrosion. The pins should not be bent
or wet.
• Replace the same cassette back onto the analyzer

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10. Troubleshooting ABL80 FLEX Operator’s Manual

• Press firmly in the middle of

the cassette at the raised circle
(just under the measuring
chamber window) until an
audible snap is heard

2. If a blockage is suspected, fill a

syringe with normal saline (Do
NOT use water or solutions from
the solution pack.). Attach this
syringe to the fluid port of the
sensor cassette and flush it with
the saline.
NOTE: Do NOT allow fluids to
contact sensor pins on the back of
the cassette.
3. • If unable to flush the sensor cassette, replace the sensor cassette
• If flushing was successful,
place the sensor cassette back
on the analyzer. Ensure the
silicone port at the rear of the
cassette is not caught under the
cassette casing. When placing
the cassette back on the
analyzer, be sure to snap
securely into place. This will
ensure proper connection of the
cassette to the analyzer.
4. Initiate a System Cycle by selecting Menu  Manual System Cycle.

Sensor cassette Follow these steps to ensure proper connection of the sensor cassette to the
connection – analyzer in the ABL80 FLEX CO-OX analyzer only:
ABL80 FLEX
Step Action
CO-OX
analyzer 1. Ensure the sensor cassette is securely connected to the front of the
analyzer.
• Remove the cassette from the analyzer
• While the cassette is off, examine the pins on the back of the
cassette. There should be no corrosion. The pins should not be bent
or wet.
2. • Ensure the fluid port (1) at the
rear of the cassette is not
caught under the cassette
casing
• Place the same cassette back
onto the analyzer

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

3. Press firmly in the middle of the

cassette at the indented circle
(just under the measuring
chamber window). It should snap
into place.

4. Initiate a System Cycle by selecting Menu  Manual System Cycle.

Solution pack Follow these steps to ensure proper connection of the solution pack to the analyzer:
connection
Step Action
1. Remove the solution pack from the analyzer:
• Press down on the door latch
• Lower the door completely
• Pull out the solution pack from the analyzer cavity
2. Examine the solution pack ports. Ensure they are clean. Any dried
solution can be carefully wiped with a soft, damp cloth.
3. Examine the luers inside the analyzer cavity. Ensure they are clean
and dry. Use a soft, damp cloth as necessary to clean this area.

4. Re-insert the solution pack

• Slide the solution pack into the cavity
• Raise the door
• Press on the door, near the latch until the latch clicks into place
5. Initiate a System Cycle by selecting Menu  Manual System Cycle.

Internal tubing If the sensor cassette and solution pack connections are verified to be secure but air
and valves contamination is still suspected, the source may be the internal tubing and valves.
Contact your local Radiometer representative for assistance.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

CO-oximeter troubleshooting

Introduction In the ABL80 FLEX CO-OX analyzer, the function of the CO-oximeter is
generally independent of the sensor cassette. The purpose of the sensor cassette is
simply to act as a fluidic pathway between the sample and the CO-oximeter.

All CO-oximeter errors are displayed on the results screen and printout with an up
or down arrow next to the out-of-range oximetry parameter.

There are a variety of additional error codes unique to the CO-oximeter. These
error messages are meant to assist Radiometer field service when troubleshooting
issues with the oximetry system. These CO-OX error codes are listed in the
“messages” section of the report.
See the Table of CO-OX error codes later in this chapter for a list of all errors.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

System Cycle The following is an example of a System Cycle printout with an error for quality
printout – control level 3 (C8303) total hemoglobin value. Note that additional CO-oximeter
system error codes are listed under the “Messages” section.
CO-oximeter
failure RADIOMETER ABL80 FLEX
SYSTEM CYCLE RESULTS

Analysis time: 6/16/2008 08:16:16

Type: Auto
SENSITIVITY VALUES

pH 51.6
CO2 54.3
O2 0.009
Na+ 61.5
K+ 56.8
Ca2+ 26.6
Cl- 47.4
Glu 0.658
tHb 282.30

QUALITY CONTROL VALUES

Solution ID: C8301 C8302 C8303 C8304

Lot: 25048 24812 24551 24880
Cycles: 141 46 53 56

pH 7.36 7.04 7.67

pCO2 35 80 14
pO2 150 67 233
cNa+ 152 103 167
cK+ 4.2 8.7 2.2
cCa2+ 1.16 2.30 0.48
cCl- 110 66 126
cGlu -0.2 16.3 4.1
ctHb 18.1  3.0 12.5

MESSAGES
Status: ? ctHb

CO-OX error(s): 581 (ctHb)

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Manual QC results out of range

Introduction This section describes the steps to perform when manual quality control results fall
outside acceptable ranges.

QC results out When manual quality control values for any level fall outside acceptable ranges:
of range
Step Action
1. Initiate a manual System Cycle (or Manual 2 Point Cal when using a
non-QC3 cassette or an ABL80 FLEX analyzer with BASIC software
configuration) by selecting Menu  Manual System Cycle.
2. Repeat the manual quality control measurement.
• If the value is in range, proceed to use the analyzer for analysis as
desired
• If the value falls outside the acceptable range a second time,
continue with step three
3. Verify the proper QC material is being analyzed. Verify the proper lot
and corresponding ranges have been correctly entered into the QC
Ranges screen.
4. Verify that the manufacturer’s recommendations regarding QC sample
handling have been followed carefully.
• For best results, it is recommended that quality control ampoules be
equilibrated to 25 °C for a minimum of five hours
• QC ampoules should be equilibrated for a minimum of five hours at
a known, stable temperature between 15 °C and 32 °C
• The exact equilibrated temperature value for the QC ampoule
should be entered into the QC Aspiration screen
• Do not handle the ampoule excessively. This can warm the ampoule
5. Thoroughly mix the ampoule liquids
by shaking for 15 seconds.

NOTE: Once opened, an ampoule must be analyzed immediately.

6. If manual QC results continue to fall outside acceptable ranges:
• Inactivate the failed parameter(s)
• Activate the QC lockout feature for this parameter or
• Replace the sensor cassette
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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Reference Chronic difficulties with QC results may indicate the need to re-evaluate your
acceptable ranges. Refer to the Radiometer “Quality Control Systems Reference
Manual” for more information regarding the establishment of user ranges.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

System messages
Introduction This section presents the various types of system messages communicated by the
analyzer. Message unique to only one analyzer version are clearly identified.
Details of the interpretation of the messages and related suggested corrective
actions are provided in this section.

The three main types of system messages include:

• General error messages - displayed in an on-screen error message box
• CO-OX error codes - reported with results
• Result messages – included in various types of result reports

System message These different types of system messages are communicated by the system in three
examples different ways.

General error messages appear in an on-screen error message box such as the one
below.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

CO-OX error codes appear in the Message section of a sample, calibration or QC

report when a CO-OX error condition occurs. The error code is listed followed by
a list of all CO-OX parameters affected. A question mark (?) will appear next to all
oximetry parameters when a CO-OX error condition is identified. The following
example shows a CO-OX error condition on a patient result.

RADIOMETER ABL80 FLEX

PATIENT RESULTS

Analysis time: 6/16/2008 08:16:16

Sample type: Arterial
MEASURED VALUES
Blood Gas (37.0 °C)
pH 7.41
pCO2 38 mmHg
pO2 81 mmHg

Oximetry
ctHb ? 14.6 g/dL
FO2Hb ? 93.6 %
FCOHb ? 1.1 %
FMetHb ? 0.3 %

Electrolytes/Metabolites
+
Na 139 mmol/L
+
K 4.2 mmol/L
2+
Ca 1.12 mmol/L
-
Cl 101 mmol/L
Glu 4.9 mmol/L

MESSAGES
Status: ? ctHb

CO-OX error(s): 581 (ctHb)

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Result messages appear as symbols or abbreviations on the results of a patient

sample, calibration or QC result. They either display next to the parameter
involved or in place of the result value. The following example shows several
result messages as they appear in a patient result.

RADIOMETER ABL80 FLEX

PATIENT RESULTS

Analysis time: 6/16/2008 08:16:16

Sample type: Arterial
MEASURED VALUES
Blood Gas (37.0 °C)
pH 7.41
pCO2  32 mmHg
pO2 81 mmHg

Oximetry
ctHb 14.6 g/dL
FO2Hb 93.6 %
FCOHb 1.1 %
FMetHb 0.3 %

Electrolytes/Metabolites
Na+ L/O mmol/L
+
K 4.2 mmol/L
2+
Ca 1.12 mmol/L
-
Cl 101 mmol/L
Glu 4.9 mmol/L

MESSAGES
Status: OK

L/O - Lockout

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

General error messages

General error This section lists the general error messages, provides interpretations and
messages recommends corrective actions. Refer to each message using its unique error
number.
The general error messages are grouped in the following categories:
1000 – System errors
1100 – Solution pack
1200 – Sensor cassette
1300 – Temperature and air detection
1400 – Manual QC
1500 – Input requirements
2000 – Communications
2100 – Oximeter
2300 – ABL80 FLEX CO-OX analyzer with OSM software configuration

General error The following table provides an interpretation of every general error message and
messages table suggested corrective actions.

Error Message Interpretation Corrective Action

1000 – System errors
1000 Invalid input The input field entry is not Enter an acceptable value
an acceptable value. in the input field.
1001 Value x not in range (y-z) The value entered (x) is not Enter a value that falls
for <parameter> within the acceptable range within the acceptable input
(y-z) for this parameter. range.
1002 Latch is open Solution pack door latch is Press on the solution pack
not fully connected. door, near the top of the
latch, until it snaps into
place.
1004 Cannot access analyzer The system experienced a Contact your local
smart chip general read / write failure of Radiometer representative.
the analyzer smart chip.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1005 Analyzer not connected The system cannot read the Contact your local
analyzer’s iButton Radiometer representative.
1006 These fields are mandatory: Certain input fields have Enter information into all
been configured for mandatory input fields.
mandatory input and no
information has been
entered.
1007 Initializing database timed The analyzer is unable to • Shutdown the analyzer
out read and/or write to the then power it up again
analyzer’s database. (re-boot)
• If the problem persists,
contact your Radiometer
representative
1008 You must enter a username Username has been Enter a valid username
configured for mandatory from the list of users on the
input. Security screen.
1009 You must enter a password Password has been Enter a valid password
configured for mandatory from the list of users on the
input. Security screen.
1010 Invalid username A username has been entered Enter a valid username
that is not present in the list from the list of users on the
of users. Security screen.
1011 Invalid password A password has been entered Enter a valid password
that is not present in the list from the user list, taking
of users. Note that the special note of the proper
password field is case case for each letter.
sensitive.
1012 Password expired The user password is Reset the user password in
expired. the Security screen.
1013 This user cannot be deleted The Administrator and None
Anonymous users cannot be
deleted.
1014 This user cannot be edited The user selected is a No action required
mandatory, default user.
Editing is not allowed

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1015 Query failed The query was unable to • Retry the query
locate the requested • If query fails, investigate
information due to some the network
type of system error. communication status
1016 Query timed out No query results were • Retry the query
received within the • If query fails, investigate
allowable time period. the network
communication status
and speed
1017 No query connection The network connection is Ensure the correct
not active. connection is selected on
the Data Request tab of the
Data Communications
screen and it is active
1018 Internal query error The internal query was • Verify the data upon
unable to find any matching which the query was
information. based is accurate
• Retry the query
• If query fails, enter data
manually
1019 No query results The query was unable to find • Verify the data upon
any matching information. which the query was
based is accurate
• Retry the query
• If query fails, enter data
manually
1020 Printer error The printer is unable to print Verify the correct paper is
successfully being used and that the
paper is properly loaded
into the printer. If the
printer error persists,
contact your Radiometer
representative

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1021 Battery is low The charge state of the Connect the analyzer to
battery is not sufficient to AC power.
complete the requested
action.
1022 No parameters were The custom parameter panel Select at least one active
selected. At least one active chosen does not include any parameter in the custom
parameter must be selected active parameters. parameter panel. (Only
active parameters are
available for selection.)
1023 Sensor cassette installation The system will not allow Connect the analyzer to
cannot be performed while sensor cassette installation AC power
on battery power on battery power
1024 Software upgrade cannot be The analyzer is currently on Connect the analyzer to
performed while on battery battery. The system requires AC power
power. AC power during an
upgrade.
1026 Analyzer locked The user is attempting to Unlock the analyzer by
perform analysis while the proceeding to the Analyzer
analyzer has been manually Lockout screen. (Menu >
locked Settings > System >
Analyzer Lockout)
1028 Analyzer iButton not The analyzer smart chip is Contact your Radiometer
programmed not properly programmed representative
1029 Unknown iButton error code The analyzer has Contact your Radiometer
experienced an unidentified representative
error in reading or writing to
the analyzer smart chip
1030 The Quick Key you pressed The Quick Key selection is Use the main menu Menu
is not operating. Please use not responding button to select the desired
the Menus instead. function.
1031 Hardware failure: unable to The analyzer has Retry: if not successful
detect CD drive experienced an error contact your Radiometer
accessing the CD drive representative

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1032 Video Tutorial file not found The analyzer is unable to Contact your Radiometer
locate the necessary files in representative
the database to run video
tutorials
1033 Unable to run Video The system is unable to run Contact your Radiometer
Tutorials the Video Tutorial feature representative
1034 Smart chip system error. The analyzer is unable to Contact your Radiometer
Remove cassette and read the smart chips in the representative
solution pack prior to consumables. The analyzer can be booted
rebooting up if desired with no
consumables attached
1035 Smart chip system error. The analyzer is unable to Contact your Radiometer
Contact Service. Replace read the smart chips in the representative.
solution pack. If error consumables. Replacement of the
persists, replace cassette. solution pack or sensor
cassette may clear the
immediate problem.
1036 Manufacture date is beyond The date in the analyzer is Verify the analyzer date
the current date before the date the and correct as necessary
consumable was
manufactured
1037 Security access denied The current user does not Modify Security settings
have permission to access for current user or have
the security screen another user log onto the
analyzer to perform the
desired action
1041 Analog board failure. The analyzer’s analog board Contact your Radiometer
Contact your Radiometer does not meet required service representative
service representative. specifications.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1100 – Solution pack
1100 Solution pack is not The solution pack smart chip • Insert the solution pack
connected was not identified by the fully into the analyzer
analyzer, indicating to the cavity. Fully close the
system that the solution pack door until the latch snaps
is not present in the analyzer closed.
cavity. • If problem persists,
replace the solution pack
• If the problem persists
with another solution
pack, contact your
Radiometer
representative
1101 Solution pack is not installed The solution pack present in Install the solution pack.
the analyzer has never been Select Menu  Utilities
successfully installed. Install  Solution Pack
and follow the instructions.
1102 The solution pack was A solution pack cannot be Install a new solution pack
installed on another installed into more than one
analyzer. It cannot be used analyzer.
on this analyzer.
1103 Solution pack previously The solution pack has No action necessary; this
installed already been installed onto pack will function with this
this analyzer. analyzer
1104 Solution pack has expired The current date is beyond Replace the solution pack
the in-use life expiration date
of the installed solution
pack.
1105 Current date is beyond the The solution pack is expired. Install a new solution pack
“install by” date of the The analyzer will not allow
solution pack an expired solution pack to
be installed.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1106 Data on solution pack is The analyzer cannot • Re-seat the solution
invalid accurately read and interpret pack. Ensure the latch is
the solution pack smart chip closed.
information. • If problem persists,
replace the solution pack
• If problem persists after
replacing the solution
pack, contact your
Radiometer
representative
The manufacture date of the Check the current date in
solution pack is prior to the the analyzer and adjust as
current analyzer date necessary
1107 Solution 1 is empty The action requested by the Replace the solution pack
user requires a certain
1108 Solution 2 is empty
quantity of solution pack
1109 Solution 3 is empty cycles that is not available in
the currently installed
1110 Solution 4 is empty
solution pack.
1111 Solution 1 is low
1112 Solution 2 is low
1113 Solution 3 is low
1114 Solution 4 is low
1115 Cannot access solution pack The system cannot read the • Re-seat the solution
smart chip information on the solution pack. Ensure the latch is
pack smart chip. closed.
• If problem persists,
replace the solution pack
• If problem persists after
replacing the solution
pack, contact your
Radiometer
representative
1116 Unable to write to solution The analyzer cannot write • Replace the solution
pack smart chip necessary information to the pack
smart chip on the solution • If problem persists,
pack. contact your Radiometer
representative

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1117 Verification check (V/C) not The verification check failed Replace the sensor
performed – Replace SC. If to meet acceptance criteria cassette. If the verification
problem persists, replace SP check failure persists,
replace the solution pack.
1118 Solution pack verification The results of the solution Replace solution pack
failed pack verification did not
meet acceptance criteria.
1119 Verification check (V/C) not The verification check could Activate the pO2 parameter
performed pO2 activation not be performed because a
required pO2 measurement is required
to complete the check.
1120 Solution pack is not installed The solution pack present in Proceed to the Solution
the analyzer was not Pack Installation screen to
installed install this pack (Menu 
Utilities  Install 
Solution Pack
1121 Insufficient solution pack The solution levels in the Replace the solution pack
cycles remaining solution pack are too low to
perform the desired function
1122 Solution pack model is not The solution pack being Replace the solution pack
compatible with this installed is not for use with with the appropriate model
analyzer this analyzer
1123 The analyzer date is prior The analyzer’s system date Correct the analyzer date
to the manufacture date of precedes the date the (Menu  Settings  Setup
the solution pack solution pack was  Date/Time)
manufactured
1124 Pouch 1 is empty Pouch 1 in the solution pack Replace the solution pack
is empty
1125 Pouch 2 is empty Pouch 2 in the solution pack Replace the solution pack
is empty
1126 Pouch 3 is empty Pouch 3 in the solution pack Replace the solution pack
is empty
1127 Pouch 4 is empty Pouch 4 in the solution pack Replace the solution pack
is empty

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1200 – Sensor cassette
1200 Sensor cassette is not The sensor cassette smart • Ensure the cassette is
connected chip was not identified by fully seated onto the
the analyzer, indicating the analyzer. Press in the
sensor cassette is not center of the cassette
connected to the analyzer. until a snap is heard.
• If problem persists,
replace the sensor
cassette
• If problem persists after
replacing the sensor
cassette, contact your
Radiometer
representative
1201 Error reading sensor cassette The analyzer cannot • Re-seat the sensor
accurately read and interpret cassette
the sensor cassette smart • If problem persists,
chip information. replace the sensor
cassette
• If problem persists after
replacing the sensor
cassette, contact your
Radiometer
representative
1202 Sample inlet flap is open The sample inlet flap is not • Lower the inlet
(ABL80 FLEX analyzer) completely lowered. completely
• If problem persists
replace the sensor
cassette
• If problem persists after
replacing the sensor
cassette, contact your
Radiometer
representative

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1203 Sensor cassette has expired The current date is beyond Replace the sensor cassette
the in-use life expiration date
of the installed sensor
cassette.
1204 Sensor cassette is not The attached sensor cassette Install the sensor cassette.
initialized has not successfully Select Menu  Utilities 
completed an installation Install  SC80 and follow
procedure. the instructions.
1205 This sensor cassette has not The attached sensor cassette Install the sensor cassette.
been installed onto this was installed onto another Select Menu  Utilities 
analyzer. Re-initialization is analyzer but has never been Install  SC80 and follow
required. successfully installed onto the instructions.
this analyzer.
1206 Sensor cassette previously This sensor cassette has No action necessary; this
installed already been successfully cassette will function with
installed onto this analyzer. this analyzer
1207 Sensor cassette requires The current calibration status Select Menu  Manual
calibration is not acceptable, either System Cycle to initiate a
because the System Cycle is System Cycle (for non-
overdue or because the last QC3 systems select Manual
System Cycle status was not 2Point Calibration)
acceptable.
1208 No more tests remaining All allowable tests have Replace the sensor cassette
been performed on the
currently installed sensor
cassette.
1209 Sensor cassette is not at The sensor cassette Place the analyzer, with
ambient temperature temperature is outside the consumables, in a location
operating temperature limit. that is within the specified
operating temperature (12-
28 °C) and allow time to
equilibrate to this
temperature.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1210 Cannot access sensor The analyzer is unable to • Re-seat the sensor
cassette smart chip read the sensor cassette cassette
smart chip. • If problem persists,
replace the sensor
cassette
• If problem persists after
replacing the sensor
cassette, contact your
Radiometer
representative
1211 Sensor cassette is not ready The glucose channel was not • Select Menu  Manual
able to meet acceptable System Cycle to initiate a
stability criteria. System Cycle (for non-
QC3 systems select
Manual 2Point
Calibration)
• If problem persists, Glu
can be inactivated, if
desired
1212 Sensor cassette install by The sensor cassette is Install a new sensor
date has passed expired. The analyzer will cassette
not allow an expired sensor
cassette to be installed.
1213 Sensor cassette must be The desired action requires a Connect a sensor cassette
connected and inlet flap sensor cassette be connected and ensure the inlet is fully
must be closed to the analyzer with the inlet lowered.
(ABL80 FLEX analyzer) lowered completely.

1214 Aspiration timed out because During the aspiration of a Lower the inlet. Re-
it did not complete within sample the inlet probe was analyze the sample,
required time period. Sample never lowered to allow ensuring the inlet is
will be discarded. sample analysis to proceed. lowered at the appropriate
time.

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Error Message Interpretation Corrective Action

1215 Analysis timed out because At least one input field was Re-analyze the sample
it did not complete within designated as a mandatory ensuring all mandatory
required time period. Sample entry and no entry was input fields are completed.
will be discarded. made. The system timed out
and discarded the sample.
1216 Unable to read sensor The analyzer is unable to • Re-seat the sensor
cassette smart chip read the sensor cassette cassette
smart chip. • If problem persists,
replace the sensor
cassette
• If problem persists after
replacing the sensor
cassette, contact your
Radiometer
representative
1217 No reportable parameters All measured parameters are • If there are active
either inactivated or have parameters, select Menu
failed the last System Cycle.  Manual System Cycle
to initiate a System
Cycle (for non-QC3
systems select Manual
2Point Calibration)
• If there are no active
parameters, proceed to
the Active Parameters
screen and activate the
desired parameters.
Otherwise replace the
sensor cassette.
1218 System Cycle failed The System Cycle results Repeat the System Cycle
did not meet acceptance Refer to the operator’s
criteria manual, chapter 10,
Troubleshooting, as
necessary

1219 Sample inlet flap opened. The sample inlet probe was Repeat the sample analysis,
Analysis will be cancelled. raised up during analysis. ensuring the inlet probe
(ABL80 FLEX analyzer) The system requires this remains down throughout
probe to remain down the analysis
throughout the sample
analysis

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1220 Sensor cassette model is not The sensor cassette being Install the correct model
compatible with this installed is not for use with sensor cassette for this
analyzer this analyzer for this analyzer and application.
application.
1221 Sample inlet probe is raised The sample inlet probe is not • Lower the inlet
(ABL80 FLEX CO-OX completely lowered completely
analyzer) • If problem persists
replace the sensor
cassette
If problem persists after
replacing the sensor
cassette, contact your
Radiometer representative
1222 Sensor cassette must be The desired action requires a Connect a sensor cassette
connected and inlet probe sensor cassette be connected and ensure the inlet is fully
must be lowered to the analyzer with the inlet lowered.
(ABL80 FLEX CO-OX lowered completely.
analyzer)
1223 Sample inlet probe is raised. The sample inlet probe was Repeat the sample analysis,
Analysis will be cancelled. raised up during analysis. ensuring the inlet probe
(ABL80 FLEX CO-OX The system requires this remains down throughout
analyzer) probe to remain down the analysis
throughout the sample
analysis
1224 Verification check (V/C) The verification check failed Replace the solution pack.
failed – replace SP. If to meet acceptance criteria If the verification check
problem persists, replace SC failure persists, replace the
sensor cassette.
1225 Two Point calibration failed The two point calibration Repeat the two point
results did not meet calibration.
acceptance criteria Refer to the operator’s
manual, chapter 10,
Troubleshooting, as
necessary

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1300 – Temperature and air detection
1301 Temperature not stable The analyzer has recognized • Re-seat the sensor
[Temp-A] an improper state of the cassette
heater / thermistor unit. • If the problem persists,
1302 Temperature not stable
(high) replace the sensor
cassette
[Temp-B]
• If the problem persists,
1303 Temperature not stable (low) contact your Radiometer
[Temp-C] representative
1304 Temperature not stable
(open circuit)
[Temp-D]

1305 Temperature malfunction The sensor cassette • Replace the sensor

(sensor overheat) temperature is well beyond cassette
[Temp-E] the desired 37 °C • If the problem persists,
temperature due to a contact your Radiometer
temperature system representative
malfunction. The analyzer
automatically shuts down the
analyzer as a safety
precaution.
1306 Sensor circuit error The heater protection circuit • Select Menu  Manual
[Temp-F] has been triggered, possibly System Cycle to initiate a
in response to low manual System Cycle (or
environmental temperature 2 Point Cal)
• Ensure the room
temperature is within the
specified operating
temperature
• Replace the SC

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1350 Air detection is unavailable The air detection system • Select Menu  Manual
check did not meet System Cycle to initiate a
acceptance criteria during manual System Cycle. If
the last System Cycle and the air detection system
the air detection system was fails again, re-install the
subsequently inactivated by sensor cassette. If the air
the user. detection calibration fails
during re-installation,
replace the sensor
cassette.
• Choose to analyze
samples without the air
detection system, if
desired
1351 Air detection calibration The air detection system • Re-install the sensor
failed calibration, during SC80 cassette. If the air
initialization, did not meet detection calibration fails
acceptance criteria. again, replace the sensor
cassette
• Choose to analyze
samples without the air
detection system, if
desired
1352 Air detection is unavailable The air detection system was • Repeat the sample
for this analysis unable to provide the measurement
necessary data to determine • Choose to accept the
the air status of the last results of the prior
measured sample. sample measurement
without the assurance of
the air detection system,
if desired
1353 Possible air in sample The air detection system has Carefully assess sample
identified the possibility that results for integrity and
air is present in the acceptable clinical
measuring chamber at the correlation. Repeat
time of the sample analysis. analysis suggested.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1354 Possible air in flush solution The air detection system has Carefully assess sample
identified the possibility that results for integrity and
air is present in the acceptable clinical
measuring chamber at the correlation. Repeat
time of the flush solution analysis suggested.
analysis.
1355 Possible air in solution 1 The air detection system has Investigate possible
identified the possibility that sources of air
air is in the measuring contamination including:
chamber during a System • Residual air in sensor
Cycle. cassette tubing. To clear,
1356 Possible air in solution 2 repeatedly pull and
release tubing during
solution flush cycles
• Solution pack empty
• Solution pack not fully
1357 Possible air in solution 3 seated into analyzer
• Sensor cassette not fully
connected to analyzer
If the source of air
1358 Possible air in solution 4 contamination cannot be
identified, contact your
Radiometer representative.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

1400 – Manual QC
1400 QC Level 1 out of range The results of the manual • Verify the proper type
<parameter> QC sample analyzed do not and lot of QC material is
fall within the acceptable being analyzed
1401 QC Level 2 out of range
ranges for the specified • Verify the temperature
<parameter>
parameter as established in of the ampoule being
1402 QC Level 3 out of range the Settings Manual QC analyzed. Ensure the
<parameter>  Ranges screen. correct temperature is
1403 QC Level 4 out of range entered during sample
<parameter> analysis
1404 QC Hct Level 1 out of range • Verify the acceptable
ranges are correct
1405 QC Hct Level 2 out of range • Repeat the QC sample
measurement
1425 QC Level 1 lot has expired The lot of manual QC Select Settings  Manual
entered in the Settings  QC  Ranges and
1426 QC Level 2 lot has expired
Manual QC  Ranges establish a new lot of QC
1427 QC Level 3 lot has expired screen is expired, according material in the Manual QC
to the Expiration field on Ranges screen.
1428 QC Level 4 lot has expired
this screen.
1429 QC Hct Level 1 lot has The analyzer will not allow
expired the use of expired QC
1430 QC Hct Level 2 lot has material.
expired
1431 All BG/Lytes QC lots have All established BG/Lytes Establish new lots of QC
expired QC lots in the Manual QC material, entering the
Ranges screen are expired associated lot numbers,
expiration dates and range
limits
1432 All Hct QC lots have expired All established Hct QC lots Establish new lots of QC
in the Manual QC Ranges material, entering the
screen are expired associated lot numbers,
expiration dates and range
limits

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Message Interpretation Corrective Action

1433 All QC lots have expired All established QC lots in Establish new lots of QC
the Manual QC Ranges material, entering the
screen are expired associated lot numbers,
expiration dates and range
limits
1450 Manual QC required Manual QC is overdue as Perform the necessary QC
specified in the QC Schedule samples or modify the QC
screen Schedule requirements
1475 Invalid barcode The barcode scanned is not Scan the correct barcode
an ABL80 FLEX QC located on the package
barcode insert
1476 The QC lot has expired The QC barcode scanned is Use only QC material that
of an expired lot of QC has not expired
material
1477 Invalid solution ID The QC barcode scanned Scan the correct barcode
does not contain a solution on the package insert
ID that is supported by the
ABL80 FLEX analyzer
1500 – Input requirements
1500 Entry is limited to x The input field has a limited Enter up to the maximum
characters number of characters. This allowable number of
number has been exceeded. characters only.
1501 Entry is limited to The input field does not Enter only letters or
alphanumeric characters allow characters other than numbers in this field.
letters or numbers.
1502 Entry is limited to numeric Text is being entered into a Enter only numbers in this
characters field that requires the entry field
of only numbers
1503 Invalid sampler ID barcode While using the FlexLink Scan or enter the correct
feature, a barcode was sampler ID barcode
entered for sampler ID that
does not meet the criteria
2000 - Communications
2000 No channel selected At least one communications Select a channel from a list
channel must be selected. of those available.
2001 Unable to activate Remote Remote connection to the Contact Radiometer
Support analyzer failed representative
2002 Unable to connect to QA The analyzer is unable to Check the IP address and
Portal successfully connect to the port number under Data
Radiometer QA Portal Communications / QA
Portal

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Message Interpretation Corrective Action

2100 – Oximeter
2100 CO-OX board failure The system has experienced Contact Radiometer
a hardware failure of a representative
circuit board associated with
the CO-oximeter
2101 CO-OX calibration required The blank calibration and/or The system will
the liquid sensor calibration automatically initiate these
for the CO-oximeter are calibrations when all
overdue. consumables have been
installed
2102 Failed CO-OX FTC version There is an incompatible Contact Radiometer
check software version on the CO- representative
oximeter hardware
2103 Invalid CO-OX firmware There is an incompatible Contact Radiometer
version software version on the CO- representative
oximeter hardware
2104 CO-OX blank calibration The CO-oximeter blank Initiate a manual System
failure calibration did not meet Cycle. If the problem
specifications persists contact Radiometer
representative.
2106 Possible fluid pathway A possible blockage has Contact Radiometer
blockage been identified in the fluidic representative
system during a System
Cycle or installation
procedure
2107 Liquid sensor failure The liquid sensor calibration Contact Radiometer
did not meet specifications representative
2108 Possible fluid pathway A possible blockage has Contact Radiometer
blockage been identified in the fluidic representative
system during a sample
analysis, manual QC
measurement or tHb
calibration
2110 tHb calibration cannot be The analyzer does not allow Connect the analyzer to
performed while on battery tHb calibration to be AC power
power performed while on battery
power
2111 Liquid sensor cal required, The liquid sensor calibration No action required
please wait is being performed at this
time. Other activities are
currently not allowed

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10. Troubleshooting ABL80 FLEX Operator’s Manual

2112 Fluid blockage test required, A fluid blockage test is No action required
please wait being performed at this time.
Other activities are currently
not allowed
2115 CO-OX temp out of range The CO-oximeter Allow time for the analyzer
temperature is currently not to bring the CO-oximeter
at the required temperature temperature into the
acceptable range. If the
temperature does not reach
an acceptable value,
contact your Radiometer
service representative.
2300 – ABL80 FLEX CO-OX analyzer with OSM software configuration
2301 SC Check required The scheduled SC Check is Initiate a manual System
overdue Cycle
2302 SC Check failed. Replace The SC Check result Replace the sensor
sensor cassette. indicates possible blockage cassette. If error recurs,
in the sensor cassette. contact Radiometer
representative.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

CO-OX error codes

Table of CO-OX The following table provides a list of CO-OX error codes that can appear in
error codes sample, calibration and QC reports under the Messages section when an error
condition occurs during the use of the ABL80 FLEX CO-OX analyzer’s CO-
oximeter.
See CO-oximeter troubleshooting earlier in this chapter for an example of where
these error codes appear.
NOTE: Each step in the User Action column is meant to be performed only if the
prior step was not successful in resolving the initial issue.

Error Code Message Description User Action

Low level messages:

1010 Oximeter data The system has not had time 1. Reboot the analyzer
collection error to make a background (dark) 2. Initiate a manual System
measurement or there is a Cycle
hardware problem.
3. Contact Service
1011 Oximeter blank The system has not performed 1. Initiate a manual System
cal required a blank calibration yet or Cycle
there is a hardware problem. 2. Reboot the analyzer
3. Contact Service
1012 Oximeter The system has not made a 1. Repeat the sample
sample spectrum sample measurement yet or measurement
not available there is a hardware problem. 2. Reboot the analyzer
3. Contact Service
1013 Oximeter data During data collection from 1. Reboot analyzer
collection error the spectrometer no trigger 2. Contact Service
signal was received or there
was a hardware problem.
1014 Oximeter blank The light received by the 1. Verify proper flow of
cal intensity too spectrometer was of too high solutions through the
high an intensity during the blank analyzer
calibration. 2. Initiate a manual System
Cycle
3. Reboot the analyzer
4. Contact Service

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Code Message Description User Action

1015 Oximeter The light received by the 1. Verify proper flow of
sample intensity spectrometer was of too high solutions through the
too high an intensity during the sample analyzer
analysis. 2. Initiate a manual System
Cycle
3. Repeat the sample
measurement
1016 Oximeter blank The light received by the 1. Initiate a manual System
cal intensity too spectrometer was of too low Cycle
low an intensity during the blank 2. Reboot analyzer
calibration.
3. Contact Service
1017 Oximeter The light received by the 1. Reboot analyzer
sample intensity spectrometer was of too low 2. Contact Service
too low an intensity during the sample
analysis.
1018 Oximeter Spectrometer offset voltage is 1. Reboot analyzer
electronic outside acceptance limits. 2. Contact Service
adjustment error
1019 Oximeter blank Peak value of blank 1. Verify proper flow of
cal outside calibration spectrum intensity solutions through the
limits is outside acceptance limits. analyzer
2. Initiate a manual System
Cycle
3. Reboot analyzer
4. Contact Service
1020 Oximeter neon Neon spectral line intensity is 1. Initiate a manual System
intensity outside outside the acceptance limits. Cycle
limits 2. Reboot analyzer
3. Contact Service
1021 Oximeter neon The Fneon value is outside 1. Initiate a manual System
correction acceptance limits. Cycle
outside limits 2. Reboot analyzer
3. Contact Service

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Code Message Description User Action

1022 Oximeter Background (dark) 1. Reboot analyzer
background measurement is outside 2. Contact Service
correction acceptance limits.
outside limits
1023 Oximeter Error reading the 1. Reboot analyzer
spectrometer spectrometer memory. 2. Contact Service
memory read
error
1024 Oximeter Error writing to the 1. Reboot analyzer
spectrometer spectrometer memory. 2. Contact Service
memory write
error
1025 Oximeter Hemolyzer resonance 1. Initiate a manual System
hemolyzer frequency auto tuning error Cycle
tuning error has occurred. 2. Contact Service
1026 Oximeter Hemolyzer frequency 1. Initiate a manual System
hemolyzer regulation error has occurred. Cycle
frequency 2. Contact Service
problem
1027 Oximeter Hemolyzer temperature 1. Verify the room
hemolyzer variation is outside temperature is within the
temperature acceptance limits at the high acceptable operating
deviation too end range for the analyzer
high 2. Reboot analyzer
3. Contact Service
1028 Oximeter neon Neon driver voltage is outside 1. Initiate a manual System
voltage outside acceptance limits. Cycle
limits 2. Contact Service
1029 Oximeter light Hemolyzer’s white LED 1. Initiate a manual System
source voltage voltage is outside acceptance Cycle
outside limits limits. 2. Contact Service

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Error Code Message Description User Action

1030 Oximeter Hemolyzer piezo voltage is 1. Initiate a manual System
hemolyzer outside acceptance limits. Cycle
voltage outside 2. Contact Service
limits
1031 Oximeter Correction matrix, necessary 1. Wait 30-50 minutes for
initialization in for absorbance calculation, is the completion of the
progress not yet complete. correction matrix
calculation
2. Initiate a manual System
Cycle
3. Contact Service
1032 Oximeter data Error occurred during data 1. Reboot analyzer
collection error collection with the DMA 2. Contact Service
controller.
1033 Oximeter task Oximetry software has not yet 1. Reboot analyzer
was not finished finished its task(s). 2. Contact Service
High level messages:
290 SHb detected FSHb has been detected in 1. No action; informational
the sample. The range is 1- message only
10%
291 SHb too high FSHb has been detected in 1. Interpret measurement
the sample. The value is results with caution
>10% which may affect
measurement accuracy
292 Turbidity too Sample has a turbidity level 1. Suggests that the sample
high of >5% measured contains a high
lipid content. As a check,
perform a measurement
on a sample with known
normal lipid content.
2. Contact Service
581 Oximeter Spectrum is not consistent 1. Verify the blood sample
spectrum with the expected blood or does not contain an
mismatch QC spectrum. Measurement interfering substance. See
may be unreliable. the reference manual for a
list of known interfering
substances.
2. Re-analyze blood sample
or manual QC sample
3. Initiate a manual System
Cycle to re-analyze a
failed automatic QC
result.
4. Contact Service

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Error Code Message Description User Action

582 tHb calibration tHb calibration Fcuv outside 1. Initiate a manual
cuvette factor acceptance limits System Cycle
outside limits 2. Repeat the tHb
calibration procedure
3. Contact Service
584 tHb calibration tHb calibration wavelength 1. Initiate a manual
wavelength outside limits System Cycle
outside limits 2. Repeat the tHb
calibration procedure
3. Contact Service
688 ctHb/ceHb too tHb < 1mmol/L or ceHb < 1. Verify the sample type
low for oximeter 0.75 mmol/L. If ctHb is too is appropriate for this
calculation low FHHb, FO2Hb, FCOHb analyzer.
and FMetHb are not
calculated. If ceHb (ceHb =
cHHb+cO2Hb) is too low,
sO2 is not calculated.
1034 Oximeter A general oximetry hardware This error will always be
hardware problem has occurred associated with additional low
problem level messages. Refer to the
low level error messages for
appropriate actions.
1037 Oximeter tHb tHb calibration error caused This error will always be
cal hardware by oximetry hardware associated with additional low
error problem level messages. Refer to the
low level error messages for
appropriate actions.
1038 Oximeter blank Blank calibration error caused This error will always be
cal hardware by oximetry hardware associated with additional low
error problem level messages. Refer to the
low level error messages for
appropriate actions.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Result messages
Table of result This table provides an interpretation of result messages that can appear while using
messages all version of the ABL80 FLEX analyzer.

Message Interpretation Corrective Action

I/A Inactive No action required.
This parameter was inactivated by the user.
L/O Parameter lock out Perform a successful QC measurement or
Sample results are not reported for this deactivate the QC lockout feature.
parameter due to manual QC results
outside acceptable limits.
P/L Parameter lockout Reactivate this parameter in the Analyzer
This parameter was manually locked out Lockout screen (Menu > Settings > System
by the user. > Analyzer Lockout).

N/A Not applicable If Hct results are desired, repeat the

Appears in the Hct field when Other Fluids analysis selecting any sample type other
is selected for sample type. than Other Fluids.

N/D Not derived Activate necessary measured parameters or

The parameter was not derived because select necessary measured parameters for
measurement parameters necessary for this reporting.
calculation are not available.
N/E No endpoint Refer to Troubleshooting: System Cycle
Stabilization criteria not met for one or Unsuccessful.
more parameters during sample
measurement, QC measurement or
calibration.
N/I Not installed If all parameters are desired, install a full
This parameter is not supported by the panel sensor cassette.
sensor cassette type installed.
R/S Results have been suppressed due to a 1. Manually initiate a System Cycle
system error associated with this or 2 Point Cal.
measurement. 2. Evaluate the integrity of the
sample and repeat the analysis if
appropriate.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Message Interpretation Corrective Action

N/R Not reported Select all desired parameters from the
This parameter was not chosen for parameter profile and repeat the analysis.
reporting by the user.
cGlu and cLac results are not reported
when Repeat sample measurement using an arterial
• The pO2 is <20 mmHg (2.7 kPa) sample with a pO2 level of ≥20 mmHg (2.7
or kPa)
• The pO2 is not measured Activate the pO2 parameter then repeat the
sample measurement. If the allowable
sample age is exceeded, consider collecting a
new blood sample for the repeat sample
measurement.
N/C Not calculated Repeat the System Cycle, replace the sensor
• QC results during a System Cycle cassette or replace the solution pack as
cannot be calculated because the necessary.
System Cycle did not result in an
acceptable sensitivity value for that
parameter.
Hct cannot be calculated due to one of the Repeat a failed calibration. If the Na+ failure
following two reasons: persists, either continue testing without Hct
or replace the sensor cassette
1. A failed Na+ calibration
Repeat the sample measurement, ensuring
2. A sample result for cNa+ that
there is no air contamination
is outside the display range

Glucose sensitivity cannot be calculated Repeat the System Cycle. If the failure
because the background zero current does persists, replace the sensor cassette.
not meet specifications
C/E Calculation error Repeat the calibration or sample
The system was unable to provide a measurement. Ensure there is no air
mathematically meaningful calculation. contamination in the sample or flush
solution.
L/E Linearity error Repeat the System Cycle. Ensure there is no
The sensitivity values from a System Cycle air contamination in the calibration solution.
do not meet linearity check criteria.
R/R Reportable range Repeat the sample measurement or modify
The parameter result is outside the user- the reportable range in the Patient Ranges
defined reportable range. screen.

I/F Initialization Failure Repeat the two-point calibration. Ensure

A sensor cassette without QC3 failed there is no air contamination in the
initialization for criteria other than measuring flowcell.
sensitivity out of range.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Message Interpretation Corrective Action

D/E Drift Error Repeat the calibration. If the problem
The difference between the calibration persists replace the sensor cassette.
value from the prior calibration to this
calibration does not meet the acceptability
criterion.
▲ Edited value No action necessary.
This value was previously edited. Review
the edit log for prior values in this field.
!! Possible air in sample Repeat the sample measurement. Expel any
The air detection system has identified air in the sample then carefully aspirate the
possible air in the sample during sample such that the measuring chamber is
measurement. free of air.

!! Possible air in flush solution Repeat the sample measurement. Ensure the
The air detection system has identified flush solution is free of air. Pulling and
possible air in the flush solution during a releasing the pump tubing during the flush
sample measurement. cycle can help dislodge any stubborn air
bubbles.
!! Possible air in solution Repeat the System Cycle. Ensure the
The air detection system has identified solutions are free of air. Pulling and
possible air in one of the solution pack releasing the pump tubing during the flush
solutions during a System Cycle. cycle can help dislodge any stubborn air
bubbles.
!! Possible fluid pathway obstruction Interpret results with caution. Contact your
A possible blockage has been identified in Radiometer representative
the ABL80 FLEX CO-OX hemolyzer.
^^ Allowable sample age exceeded Interpret the results with caution. Analyze a
The FlexLink system has calculated the new sample if desired.
age of the sample to be beyond the user-
defined allowable limit
*** Parameter value is beyond the analyzer Evaluate the integrity of the sample. Perform
measuring range. a manual System Cycle and repeat the
sample analysis.
### Sensor response is beyond the sensor Initiate a manual System Cycle. Ensure the
response range. system is free of air bubbles. Repeat the
sample analysis.

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Message Interpretation Corrective Action

¿ Manual QC out of range Repeat manual QC measurement until results
Sample results for this parameter are in meet acceptability criteria then repeat the
question due to a failed manual QC sample measurement.
measurement.
? Drift Evaluate the magnitude of the drift in the
The analyzer has identified excessive drift System Cycle log. Monitor the drift values as
for a parameter from the last System Cycle desired.
to the current one.
ABL80 FLEX CO-OX error Interpret results with caution. Repeat the
The analyzer’s CO-oximeter experienced calibration or measurement if desired. If
one or more error conditions problem persists, contact your Radiometer
representative
The sample analysis result is above or No action required for sample analysis.
below the user-defined reference value.
The quality control result (either manual or Perform a manual System Cycle. Then, if
from a System Cycle) is above or below necessary, repeat manual QC analysis (see
the acceptable QC range. Manual QC Results Out of Range).
The sample analysis result has fallen No action required. Results should be
beyond the user-defined critical limit. correlated to the clinical condition of the
patient to verify appropriateness.
The sample analysis result has fallen Repeat the analysis if appropriate.
outside the test range.

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Battery management
Introduction All versions of the ABL80 FLEX analyzer can be used on battery power. The
analyzer contains four lithium-ion cells within a battery pack that provides a power
output capable of supporting analyzer functions.

Battery life All versions of the ABL80 FLEX analyzer can remain in an idle state with a fully
charged battery pack for approximately one hour.

Charge time A depleted battery pack will require approximately 1 hour and 20 minutes to fully
charge.

Battery The analyzer main menu displays several icons related to power and the battery
indicators status. These icons are in the bottom right corner of the screen to the left of the
time of day.
Main menu on AC power:

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Main menu on battery power:

Icon Description
The analyzer is plugged into a wall socket and is running on AC
power.
The analyzer is running on battery power. The battery pack is fully
charged. At this power level, SC80 installation and tHb calibration
is not permitted.
The analyzer is running on battery power. The battery pack is ¾
charged. At this power level, SC80 installation and tHb calibration
is not permitted.
The analyzer is running on battery power. The battery pack is ½
charged. At this power level SC80 installation, tHb calibration, SP
installation, System Cycles and 2-point calibrations are not
permitted.
The analyzer is running on battery power. The battery pack is ¼
charged. At this power level shutdown of the analyzer is imminent.

Analyzer Once the analyzer battery power falls below the minimum threshold, the analyzer
shutdown will shut itself down. A warning message will appear on the screen while the
analyzer software and hardware is closed down in a controlled manner. To power
the analyzer back on, connect the analyzer to an AC source.

Battery Over time, the battery pack will lose capacity and require replacement. Please
replacement contact your Radiometer representative for battery pack replacement.

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10. Troubleshooting ABL80 FLEX Operator’s Manual

Sleep mode When the analyzer has been disconnected from an AC source and turned off for
more than eight hours the system will automatically go into a sleep mode (“low
power storage mode”) to conserve battery power. Once in sleep mode the analyzer
must be connected to AC power prior to powering up the analyzer.

Battery life It is recommended to periodically (biannually) cycle the battery to maintain

optimal performance. To cycle the battery, allow the analyzer to run on battery
power until it shuts down. Then reconnect the analyzer to an AC source and allow
the battery to fully recharge.

LED indicators There are three LED lights at the rear of the analyzer that communicate the
power/charge status of the analyzer.
When the analyzer is connected to an AC power source, the power supply will
continue to charge the battery, even when the analyzer has been shut down.
When the analyzer is fully shut down and disconnected from AC power, all LEDs
will be OFF.
The following picture and table describes the location and meaning of the power
supply indicators.

Part Function
Top LED Power status
• Green – connected to AC power, analyzer is OFF
• Orange – running on AC power, analyzer is ON
• Red – running on battery power, analyzer is ON
Middle LED Internal power status
• Green – internal power is operating properly
• Red – internal power problem; contact your Radiometer
representative

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ABL80 FLEX Operator’s Manual 10. Troubleshooting

Bottom LED Charger status

• Slow green flash – charging battery pack
• Fast green flash – battery pack is in discharge state
• Green – battery pack is fully charged
• Red – battery pack is not connected; contact your
Radiometer representative
• Off – running on battery power, analyzer is ON

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 11. Sampling

Introduction This chapter provides guidelines and recommendations for blood sample
collection prior to analysis, i.e. the preanalytical phase, in order to avoid errors and
obtain the most accurate results.

For more comprehensive information regarding blood sampling, see the references
at the end of this chapter.

In this chapter This chapter covers the following topics:

Causes of errors in the preanalytical phase..........................................11-2
Preparation prior to arterial/venous sampling......................................11-5
Preparation prior to capillary sampling ...............................................11-7
Sampling devices .................................................................................11-8
Storage and preparation prior to analysis ..........................................11-10
Sampling procedures ..........................................................................11-12
References ..........................................................................................11-13
11. Sampling ABL80 FLEX Operator's Manual

Causes of errors in the preanalytical phase

Introduction The major source of errors in blood sample analysis is the preanalytical phase, i.e.
sample collection and handling prior to transfer into the analyzer. In order to avoid
errors, it is necessary to observe certain guidelines during:
• Preparation prior to sampling
• Sampling
• Transport
• Storage
• Preparation prior to transfer of the sample into the analyzer

WARNING Blood sampling should be performed by authorized personnel only. Always handle
blood and the collection devices with care. Avoid direct contact with the sample
by using certified protective gloves. Sterile techniques are required at all times to
avoid infection.

Causes of error Some possible causes of error during the preanalytical phase of sample analysis,
along with preventative measures are listed below:
Cause of Error Parameters Most Affected Preventative Measure
Air bubbles in sample pO2 Expel all air bubbles from
the sample immediately
Cell sedimentation ctHb, Hct, pO2, pCO2 Mix the sample thoroughly
prior to sample aspiration
Hemolysis cNa+, cK+, cCa2+, cCl-, Hct • Avoid using sampling
needles with a narrow
inner diameter
• Avoid squeezing the tissue
surrounding the patient
sampling site during
capillary sample collection
• Avoid mixing the sample
too vigorously
• See section Storage and
preparation prior to
analysis further in this
chapter

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ABL80 FLEX Operator's Manual 11. Sampling

Cause of Error Parameters Most Affected Preventative Measure

+ + 2+ -
Liquid heparin dilution cNa , cK , cCa , cCl , cGlu, Use only pre-heparinized
pCO2, cHCO-3, pO 2, ctHb blood gas syringes with dry
heparin
Heparin interference cNa+, cK+, cCa2+, cCl-, Hct Use only electrolyte-
balanced heparin
Arterial blood mixed pO2, sO2, pCO2, pH Use proper sampling
with venous blood technique (an unexpectedly
low pO2 can often be
verified using pulse
oximetry).
Instability of the patient pH, pO2, pCO2 • Collect sample at least 20
minutes after ventilatory
adjustments
• Inform and explain the
procedure to the patient to
minimize anxiety
Red blood cell leakage cK+ Store glass (not plastic)
capillary samples for no
more than 30 minutes in
cold (0-4 ºC) conditions
Dilution of sample with cNa+, cK+, cCa2+, cCl-, cGlu, Discard a sufficient volume
flush solution from cLac of flush from the catheter
catheter prior to blood sampling
Infusion solution being cNa+, cK+, cCa2+, cCl-, cGlu, Stop the infusion during
introduced in the same cLac sampling or use another
arm sample site

See also Recommended literature at the end of this chapter.

Selection of To avoid introduction of clotted blood samples into the analyzer, which may give
anticoagulant inaccurate measurement results and interfere with analyzer function, Radiometer
recommends the following:
• Exclusive use of pre-heparinized sampling devices
• Exclusive use of dry heparin, preferably of sodium or lithium
• Do not use liquid heparin, as this causes dilution of the sample [1]
• Use heparin in sufficient concentration. The recommended concentration
depends on the sampling device and specific blood sample. Please refer to
documentation for specific sampling devices.
• Use electrolyte-balanced heparin to minimize bias from heparin on electrolyte
values
WARNING/CAUTION: Do not add sodium fluoride to the blood samples, as it
gives erroneously high cNa+, and low cCa2+ and cGlucose results. Sodium fluoride
also damages the glucose electrode.

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11. Sampling ABL80 FLEX Operator's Manual

The respiratory condition of the patient should be stable.

• The patient should preferably be in a steady state of ventilation before and
during the collection of the blood sample.
• The patient should be informed about the procedure in order to avoid
unnecessary anxiety. If the patient hyperventilates due to anxiety, for example,
pH and blood gases may be affected.

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ABL80 FLEX Operator's Manual 11. Sampling

Preparation prior to arterial/venous sampling

Sample types The recommendations and considerations for the sample type are as follows:
Sample Type Recommendations and considerations
Arterial The most preferred and recommended type of blood for pH/blood
gas analysis.
• Gives the best information about oxygen uptake in the lungs and
oxygen transport
• Information is basically the same regardless of the sampling site
Venous Not generally recommended for blood gas analysis
• Affected by peripheral circulatory efficiency and cellular
metabolic needs
• Should not be used to evaluate oxygen status
• Can be used to reflect acid-base status (pH, pCO2, cBase(Ecf),
ctHb, FCOHb and FMetHb

Arterial and The recommendations and considerations for selecting a sampling site are as
venous sampling follows:
sites
Sample Site Advantages/disadvantages
Arterial Radial • Good collateral circulation
artery
• Easy access
• Prior to sampling from the radial artery, perform a
Modified Allen’s Test to confirm adequate
collateral circulation.
Brachial • Difficult to puncture due to location
artery
• Greater risk of damage to surrounding structures
Femoral • Large and easy to puncture
artery
• Poor collateral circulation
• Should be avoided on newborns and elderly
Arterial line • Remove the flush solutions used in A-lines
completely from the system to avoid dilution of the
blood sample. It is recommended to withdraw a
volume equal to three to six times the "dead space"
of the catheter.
Venous Brachial • Convenient site
vein
• For sampling on venous blood, use the standard
procedure of your institution

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11. Sampling ABL80 FLEX Operator's Manual

Arterial The following are guidelines for sampling by arterial puncture:

sampling
Sampling method Guidelines
guidelines
Puncture • Be careful not to mix venous blood with the arterial
sample. This can occur if a vein is punctured before
locating the artery. Arterial blood (due to the higher
pressure) will generally fill faster than venous blood, and
is lighter in color.
• It is important to expel any air bubbles immediately
without prior agitation. An air bubble with a relative
volume of 0.5% or more of the blood volume in the
syringe is a potential source of significant error [2, 3 ,4].
The effect of such an air bubble increases with the storage
time and agitation of the sample.
• Mix sample thoroughly with heparin immediately after
sampling by inverting the sampler several times and then
rolling the sample between your palms.
A-line • If aspirating the sample, do so slowly in order to avoid
hemolysis of the sample
• Expel any air bubbles immediately (see above)
• Mix the sample thoroughly with heparin immediately after
sampling by inverting the sampler several times and then
rolling the sample between your palms.

Disposal of used WARNING/CAUTION: Discard the waste as infectious waste [4].

sampling
devices

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ABL80 FLEX Operator's Manual 11. Sampling

Preparation prior to capillary sampling

Capillary The following are recommended capillary sampling sites:

sampling sites
• Earlobe
• Finger tip
• Fetal scalp
• Big toe*
• Heel*
*The big toe and heel should not be used on patients older than six months

WARNING/CAUTION: In general, results obtained from capillary samples,

particularly pO2 values, should be interpreted with caution.

Capillary The guidelines for capillary sampling are as follows:

sampling
• Arterialize the puncture site by warming it up to approximately 42 °C (108 °F)
guidelines
for five to ten minutes prior to actual sampling. Failure to do so will make the
blood sample only representative of the local tissue, and not the general status of
the patient.
• Make a puncture using a lancet or the like, so that blood flows freely. Do not
squeeze the area.
• Remove the first drop of blood, since it may be diluted with tissue fluid. Take
the sample from the center of the second blood drop. To prevent air from
entering the capillary, take the sample from the center of the drop.
• Squeezing or milking the puncture site is to be avoided as this will result in an
admixture of blood and tissue fluid, resulting in faulty measurements. It can also
cause hemolysis of the blood sample (or part of the sample), resulting in cK+
readings being too high.
• Mix the sample with heparin immediately after collection to prevent blood from
clotting. Clots can block the analyzer and cause unnecessary downtime. Use a
mixing wire and magnet when mixing a capillary sample.

Disposal of used WARNING/CAUTION: Discard the waste as infectious waste [4].

sampling
devices

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11. Sampling ABL80 FLEX Operator's Manual

Sampling devices

Introduction Radiometer has an assortment of specialized blood gas sampling devices. The
PICO sampler product line is used for puncture and A-line sampling, and
CLINITUBES capillary tubes are used for capillary sampling.
For ordering information on sampling devices, see Chapter 13, Ordering
information or contact your local distributor of Radiometer products.

Arterial blood The following arterial blood samplers, available from Radiometer, are
samplers recommended:
• PICO70: Self-filling arterial blood sampler for arterial puncture or A-line
sampling (for use with the ABL80 FLEX analyzer only)
• PICO50 (2 mL): Arterial blood sampler for other aspiration of arterial blood
from A-lines (all ABL80 FLEX analyzer versions)
• safePICO: Self-filling arterial blood sampler for arterial puncture or A-line
sampling (contains a steel ball for automatic sample mixing in a hand-held
automatic sample mixer)

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ABL80 FLEX Operator's Manual 11. Sampling

CLINITUBES - ABL80 FLEX analyzer

The following CLINITUBES capillary tubes (for capillary blood sampling) are
available from Radiometer and are recommended for the ABL80 FLEX analyzer:
• D957P-70-70
• D941G-240-85
• D941P-NA-240-85
• D941G-NA-240-85
• D941P-NA-240-85
• D957P-70-100
• D956G-70-100
• D957G-70-100
• D956G-70-125
• D957G-70-125
• D956G-70-210
• D957G-70-210
(G = glass; P = plastic; the last figure designates volume in µL)

CLINITUBES - The following CLINITUBES capillary tubes (for capillary blood sampling) are
ABL80 FLEX available from Radiometer and are recommended for the ABL80 FLEX CO-OX
CO-OX analyzer:
analyzer
• D957P-70-125
• D956G-70-125
• D957G-70-125
• D956G-70-210
• D957G-70-210
(G = glass; P = plastic; the last figure designates volume in µL)

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11. Sampling ABL80 FLEX Operator's Manual

Storage and preparation prior to analysis

Storage recom- Radiometer recommends the following for samples obtained in plastic and glass
mendation syringes:
Sampler material Storage recommendation
Plastic syringe • Storage should be avoided whenever possible or, at
least, kept to a minimum
• If it is not possible to analyze the sample immediately,
analyze it within 30 minutes after collection [5, 6, 7, 8,
9, 10, 11]
• The recommended storage temperature is room
temperature [5, 6, 8]
• Samples with expected high pO2 values or samples used
in special studies (e.g. shunt studies) should be analyzed
immediately or within five minutes. The use of glass
syringes should be considered [5, 7, 8]
Glass syringe • Storage should be avoided whenever possible or, at
least, kept to a minimum
• If it is not possible to analyze the sample immediately,
analyze it within 30 minutes after collection when
stored at room temperature [5, 12]
• Alternatively, the sample can be stored in ice water
(0–4 ºC, 32-39 °F). The storage time should not exceed
one hour. [13]
• Samples with expected high pO2 values or samples used
in special studies (e.g. shunt studies) should be analyzed
immediately or within five minutes. [13]

Radiometer recommends the following for samples obtained in plastic and glass
capillaries:
Material Storage recommendation
Plastic capillary Analyze the sample within 10 minutes. Note that for samples
with pO2 > 80 mmHg (10.7 kPa) a positive bias from 1-9% is
observed. The bias depends on the pO2, pH and time.
Glass capillary Analyze the sample within 10 minutes. If storage is
unavoidable, store the sample horizontally at 0-4 °C (32-39 °F)
for a maximum of 30 minutes.

Special For some samples, the recommendations above do no apply and individual
considerations guidelines should be used or developed. This may include samples with an
increased leukocyte or platelet count, fetal scalp samples, samples with atypical
metabolism, fast-clotting samples, etc. [9, 14]
Typical metabolic activity in blood samples causes a decrease in the glucose
concentration. For samples within the typical reference range, this corresponds to

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ABL80 FLEX Operator's Manual 11. Sampling

an average glucose change of -0.2 mmol/L over 30 minutes at room temperature.

[15]

Preparation Arterial puncture and A-line samples:

prior to analysis
• If there is an air bubble in a sample that has been stored, pH and blood gas
values should not be reported
• Thoroughly mix the sample by inverting the sampler several times and rolling it
between the palms of your hands

Capillary samples:
• Thoroughly mix the sample with heparin using a mixing wire and magnet.
Remove the mixing wire prior to aspiration into the analyzer when plastic
capillary tubes are used.

Capillary blood To ensure performance in accordance with the analyzer performance

sample specifications, Radiometer recommends the following:
measurements

Capillary blood sample • When performing capillary blood sample

measurements measurements, use the mixing wire in order to ensure
appropriate mixing of the sample and thereby prevent
clots from being introduced into the analyzer. The
sample should be mixed immediately after collection,
moving the mixing wire with a magnet 20 times along
the full length of the capillary. This procedure should
be repeated immediately before analyzing the sample.
• When using a glass capillary tube, the mixing wire
may be left in the tube during sample aspiration. Slide
the mixing wire to the end of the capillary opposite to
that from which the blood is to be aspirated.
Capillary blood sample • When performing capillary blood sample
measurements on fetal measurements on fetal scalp blood, insert the mixing
scalp blood wire into the capillary tube after the sample has been
collected
• When performing measurements on fetal scalp blood,
introduce the capillary sample into the analyzer from
the end free from Vaseline smear. In case both
capillary ends are smeared, dry one of the ends with a
lint-free tissue before measurement.
• Due to their inherent characteristics, fetal scalp blood
samples are generally regarded as potentially difficult
to work with. An important prerequisite for
successfully analyzing fetal scalp blood samples is
the sample quality. Ensure that the preanalytical
precautions listed above are followed very closely.

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11. Sampling ABL80 FLEX Operator's Manual

Sampling procedures

NOTE: This section describes non-Radiometer sampling devices. For information on

proper use and handling of Radiometer sampling devices, please refer to the
inserts supplied with the sampling devices.

Sampling with a Prepare the following together with a standard syringe (dead space 2-6%):
standard
• Anticoagulant: lithium or sodium heparin (1000 IU/mL whole blood or plasma
syringe
samples)
• Two needles 20-25 gauge
• Tourniquet (for venous samples)
• Skin antiseptic, e.g. 70% alcohol
• Sterile gauze sponge or cotton wool
• Rubber stopper or syringe end cap (stainless steel)
• Adhesive tape and pressure dressing

To obtain a blood sample using a standard syringe, perform the following steps:
Step Action
1. Mount a needle on the syringe and draw the heparin into the syringe.
2. Change the needle and flush the barrel walls, then expel air and
heparin through the needle.
3. Extend the patient’s arm. Apply the tourniquet for a venous puncture.
4. Locate the blood vessel using a fingertip and clean the skin area with
antiseptic and a sterile gauze sponge or cotton wool.
5. Insert the needle in the vessel with the bevel facing up. Withdraw the
syringe plunger gently to collect blood.
6. Release the tourniquet (if used), remove the needle, and immediately
apply dry gauze or cotton wool over the puncture site. Maintain
pressure on an arterial puncture site for at least five minutes.
7. Apply a pressure dressing over the puncture site and elevate the site
for at least two to three minutes, if possible.
8. Expel any air bubbles from the syringe and remove the needle
according to your standard procedure.
9. Mix the sample by inverting the syringe several times then rolling it
between your palms.
10. Mix the sample again immediately before analysis. Analyze the
sample immediately.

11-12
ABL80 FLEX Operator's Manual 11. Sampling

References

List of This section lists the references applicable to blood sampling and blood gas
references analysis associated with this chapter.

1. Avoid errors in arterial blood sampling. Copenhagen: Radiometer

Medical A/S, 1992. REF 919-467.
2. Biswas CK, Ramos JM, Agroyannis B, Kerr DNS, Blood gas
analysis: effect of air bubbles in the syringe and delay estimation. B
Med J 1982; 284: 923-27.
3. Mueller RG, Lang GE, Beam JM. Bubbles in samples for blood gas
determinations – a potential source of error. Am J Clin Pathol 1976;
65: 242-49.
4. Clinical laboratory waste management. 2nd ed. NCCLS publication
GP5-A2. Wayne, PA: NCCLS, 2002: 22, 3.
5. Blonshine S, Alberti R, Olesinski RL. Procedures for the collection of
arterial blood specimens. 4th ed. CLSI publication H11-A4. Wayne,
PA: CLSI, 2002: 24, 28.
6. Mahoney JJ, Van Kessel A. Arterial blood gas analysis. Respiratory
Care 1997: 249-79.
7. Smeenk F, Janssen J, Arends B, Harff G, Bosch J, Schönberger J,
Postmus P. Effects of four different methods sampling arterial blood
and storage time on gas tensions and shunt calculation in the 100%
oxygen test. Eur Respir J 1996; 10: 910-13.
8. Mahoney JJ, Harvey JA, Wong RJ, Kessel VLA. Changes in oxygen
measurements when whole blood is stored in iced plastic or glass
syringes. Clin Chem 1991; 37: 1244-48.
9. Wooley A, Hickling K. Errors in measuring blood gases in the
intensive care unit: Effect of delay in estimation. Journal of Critical
Care 2003; 18: 31-37.
10. Blonshine S. To ice or not to ice. AARC Times 2000: 37-39.
11. Liss P, Payne P. Stability of blood gases in ice and at room
temperature. Chest 1993; 103:1120-21.
12. Burnett RW, Chatburn RL, Christiansen TF et al. Blood gas
preanalytical considerations: specimen collection, calibration and
controls. NCCLS publication C27-A. Villanova, PA: 1993; 13, 6.
13. Burnett RW, Covington AK, Fogh-Andersen N et al. Approved IFCC
recommendations on whole blood sampling, transport and storage for
simultaneous determination of pH, blood gases and electrolytes. Eur J
Clin Chem Clin Biochem 1995; 33: 247-53.
14. Nickelsen CN. Fetal capillary blood pH. http://www.bloodgas.org /
2002.
15. Wennecke G. Useful tips to avoid preanalytical errors in blood gas
testing: metabolites. http://www.bloodgas.org / 2004.

11-13
11. Sampling ABL80 FLEX Operator's Manual

Recommended 1. Capillary sampling. In: The whole-blood sampling handbook.

literature Copenhagen: Radiometer Medical ApS, 2003. REF 989-466.
2. Christiansen TF. Heparin and blood sampling for pH, blood gases and
direct potentiometric electrolyte analysis. Radiometer Publication
AS96. Copenhagen: Radiometer Medical A/S, 1986.
3. The blood gas handbook. Copenhagen: Radiometer Medical ApS,
2004. REF 989-318.
4. Bower LK, Barnhart SL, Betit P, Hendon B, Masi-Lynch J, Wilson
BG. AARC Clinical practice guideline. Capillary blood gas sampling
for neonatal and pediatric patients. Respir Care 1994; 39, 12: 1180-
83.
5. Christiansen TF. Measurement of potassium in whole blood.
Radiometer Publication AS92. Copenhagen: Radiometer Medical
A/S, 1983. REF 918-231.
6. Wandrup JH. Clinical and analytical requirements and needs of
glucose measurements on whole blood. Radiometer Publication
AS122. Copenhagen: Radiometer Medical A/S, 1996. REF 918-549.
7. Wu E, Barazanji K, Johnson R. Sources of error in A-aDO2 calculated
from blood stored in plastic and glass syringes. J Appl Physiol 1997;
82: 196-202.

11-14
 12. Specifications

Introduction This chapter provides the physical and operational specifications for all ABL80
FLEX analyzer versions.

Contents This chapter contains the following topics.

Measured parameters ...........................................................................12-2
Calculated parameters ..........................................................................12-4
Input parameters ...................................................................................12-7
Physical and operating specifications ..................................................12-8
Approvals and compliances ...............................................................12-11
Symbols list ........................................................................................12-13
Patents ................................................................................................12-15
12. Specifications ABL80 FLEX Operator’s Manual

Measured parameters
Test range The test range for a parameter is the range within which accuracy and precision of
a measured parameter was specified by the manufacturer. Any value outside this
test range will have or printed next to the value.

Measuring The measuring range is defined as the limits within which the analyzer is capable
range of displaying parameter values. Any value calculated to be outside the measuring
range is displayed as three asterisks (* * *).

Blood The following table lists all the measured parameters available on all versions of the
ABL80 FLEX analyzer.
Parameter Unit Test range Measuring range
pH 7.00–7.70 6.00–8.00
pCO2 mmHg 15.0–125.0 0.0–150.0
kPa 2.00–16.70 0.00–20.00
pO2 mmHg 14–420 0–760
kPa 1.9–56.0 0.0–101.3
cNa+ mmol/L 120–180 0–210
mEq/L
cK+ mmol/L 2.00–8.00 0.00–20.00
mEq/L
cCa2+ mmol/L 0.50–2.50 0.00–5.00
mEq/L 1.00–5.00 0.00–10.00
Mg/dL 2.00–10.00 0.00–20.00
cCl- mmol/L 85–140 0–250
mEq/L

cGlu mmol/L 2.0–40.0 0.0–75.0

(not available in the
ABL80 FLEX analyzer
with BASIC software
configuration) mg/dL 36–720 0–1351

cLac mmol/L 0.3–20.0 –1.0–40.0

(only available in the meq/L
ABL80 FLEX analyzer
mg/dL 3–180 –9–360
with BASIC software
configuration)
Hct % 10–75 0–85
(ABL80 FLEX analyzer
only)

12-2
ABL80 FLEX Operator’s Manual 12. Specifications

Blood – ABL80 The following table lists the additional measured parameters available only on the
FLEX CO-OX ABL80 FLEX CO-OX analyzer.
analyzer
Parameter Unit Test range Measuring range*
ctHb g/dL 7.0–25.0 0.0–27.7
g/L 70.0–250.0 0.0–270.7
mmol/L 4.3–15.5 0.0–17.2
sO2 % 0.0–100.0 0.0–100.0
fraction 0.000–1.000 0.000–1.000
FO2Hb % 0.0–100.0 0.0–100.0
fraction 0.000–1.000 0.000–1.000
FCOHb % 0.0–20.0 0.0–100.0
fraction 0.000–0.200 0.000–1.000
FMetHb % 0.0–20.0 0.0–100.0
fraction 0.000–0.200 0.000–1.000
FHHb % 0.0–100.0 0.0–100.0
fraction 0.000–1.000 0.000–1.000
* The values are for the analyzer with the activated “Out-of-range suppression”
function. In case this function has not been activated, the default measuring ranges
will be as follows:

Parameter Unit Measuring range

ctHb g/dL -1.0–27.7
g/L -10.0–270.7
mmol/L -0.6–17.2
sO2, FO2Hb, FCOHb, FMetHb, % -2.0–102.0
FHHb fraction -0.020–1.020

12-3
12. Specifications ABL80 FLEX Operator’s Manual

Calculated parameters
Derived The following table lists all the derived parameters available on all versions of the
parameters ABL80 FLEX analyzer.
Parameter Unit Display range Input value
required
cHCO3–(P) mmol/L mEq/L 0.0–99.0
cBase(B) mmol/L mEq/L +50.0
cBase(Ecf) mmol/L mEq/L +30.0
cBase(B,ox) mmol/L mEq/L +50.0
cBase(Ecf,ox) mmol/L mEq/L +30.0
–
cHCO3 (P, st) mmol/L mEq/L 0.0–99.0
cCa2+(7.40) mmol/L 0.20–8.10
mEq/L 0.40–16.20
mg/dL 0.80–32.40
ctCO2(B) mmol/L 0.0–99.0
ctCO2(P) mmol/L 0.0–99.0
sO2 % 0.0–100.0
ctHb G/dL 1.0–28.0
g/L 10.0–280.0
mmol/L 0.6–17.4
Anion Gap (K+) mmol/L 0.0–99.0
Anion Gap mmol/L 0.0–99.0
ctO2 vol% 0.0–45.0
mmol/L 0.0–20.1
pO2(A) mmHg 0–800 Baro, FO2(I)
kPa 0.0–106.7
pO2(A-a) mmHg 0–800 Baro, FO2(I)
kPa 0.0–106.7
pO2(a/A) 0.00–1.00 Baro, FO2(I)

12-4
ABL80 FLEX Operator’s Manual 12. Specifications

Parameter Unit Display range Input value

required
RI % 0.0–35.0 Baro, FO2(I)
pH(T) 6.00-8.00 Patient temperature
pCO2(T) mmHg 0-150 Patient temperature
kPa 0.0-20.0
pO2(T) mmHg 0-760 Patient temperature
kPa 0.0-101.0
pO2(A, T) mmHg 0–800 Baro, FO2(I), Patient
temperature
kPa 0.0–106.7
pO2(A-a, T) mmHg 0–800 Baro, FO2(I), Patient
temperature
kPa 0.0–106.7
pO2(a/A, T) 0.00–1.00 Baro, FO2(I), Patient
temperature
RI(T) % 0.0–35.0 Baro, FO2(I), Patient
temperature
mOsm mmol/kg 0–495

Derived The following table lists additional derived parameters available only on the ABL80
parameters – FLEX CO-OX analyzer.
ABL80 FLEX
Parameter Unit Display range Input value
CO-OX
required
analyzer
Hct % 0–85
p50 mmHg 0-760
kPa 0-101.0
p50(T) mmHg 0-760 Patient temperature
kPa 0-101.0
p50(st) mmHg 0-760
kPa 0-101.0

12-5
12. Specifications ABL80 FLEX Operator’s Manual

Parameter Unit Display range Input value

required
FShunt % 0.0-100.0 Baro, FO2(I),

pO2(v– ), sO2(v– )
fraction 0.000-1.000
FShunt(T) % 0.0-100.0 Baro, FO2(I), pO2(v–
), sO (v– )
2

Patient temperature
fraction 0.000-1.000
pO2(a)/FO2(I) mmHg 0-7600 FO2(I)
kPa 0-1013.3
pO2(x) mmHg 0-760
kPa 0-101.0
BO2 mmolL 0.0-100.0
Vol% mL/dL 0.0-224.1
· mL/min 0-22414 ·
D O2 Qt
mmol/min 0.0-1000.0
· L/min 0.0-100.0 ·
Qt VO2
· mL/min 0-22414 ·
VO2 Qt
Qx --- ---
V(B) L 0.0-20.0 VCO, FCOHb(1),
FCOHb(2)

12-6
ABL80 FLEX Operator’s Manual 12. Specifications

Input parameters
Input See Chapter 4, Sample measurements for a complete list of all input parameters.
parameters

12-7
12. Specifications ABL80 FLEX Operator’s Manual

Physical and operating specifications

Sample volume – ABL80 FLEX Approximately 70 µL
analyzer (both software
configurations)
Sample volume – ABL80 FLEX Approximately 105 µL
CO-OX analyzer with CO-OX
software configuration
Sample volume – ABL80 FLEX Approximately 65 µL
CO-OX analyzer with OSM
software configuration
Sample type Heparinized whole blood
Analysis / Cycle time – ABL80 Approximately 100 - 115 seconds
FLEX analyzer (both software
configurations)
Analysis / Cycle time – ABL80 Approximately 140 seconds
FLEX CO-OX analyzer with CO-
OX software configuration
Analysis / Cycle time – ABL80 Approximately 60 seconds
FLEX CO-OX analyzer with OSM
software configuration
System Cycle Approximately 4 minutes in ABL80 FLEX analyzer
Approximately 7 minutes in ABL80 FLEX CO-OX analyzer
with CO-OX software configuration
Approximately 4 minutes in ABL80 FLEX CO-OX analyzer
with OSM software configuration
2 Point Calibration Approximately 2 minutes in an ABL80 FLEX analyzer with
BASIC software configuration
Measurement methodology – Amperometric, potentiometric and conductometric
ABL80 FLEX analyzer microelectrode technology
Measurement methodology – Amperometric and potentiometric microelectrode
ABL80 FLEX CO-OX analyzer technology; spectrophotometry
SC80 storage and transportation SC80 REF 945-806 and 2–25 °C (36–77 °F) with an
temperature 945-843 allowable excursion up to 32
°C for a two week maximum
SC80 versions with lactate 2–8 °C (36–46 °F) with an
allowable excursion up to 25
°C for a 10 day maximum
All other SC80 versions 5–25 °C (41–77 °F) with an
allowable excursion up to 32
°C for a two week maximum

12-8
ABL80 FLEX Operator’s Manual 12. Specifications

Solution pack storage and All SP80 versions except 5–25 °C (41–77 °F)
transportation environment REF 944-341
SP80 REF 944-341 2–25 °C (36–77 °F)
All versions have an allowable excursion up to 32 °C for a
two week maximum
All versions have an altitude range of sea level to 2290
meters (7513 feet) (Sea level to 575 mmHg or 76.7 kPa)
Analyzer operating environment (all 12-28 °C (54–82 °F)
versions)
Sea level to 2290 meters (7513 feet)
(Sea level to 575 mmHg or 76.7 kPa)
Relative humidity 100% non-condensing
Sample measurement temperature 37.0 °C (36.7-37.1 °C)
Records Up to 500 patient tests, 500 System Cycle results, 500 2-Pt
Cal results, 500 manual QC results, 1500 events and 1500
security records
Dimensions Height: 40 cm (16 in.)
Width: 22 cm (9 in.)
Depth: 28 cm (11 in.)
Weight 8.5 kg (19 lbs)
CD drive R/RW drive. CD drive not available in analyzers
manufactured in 2011 and onwards.
Computer specifications Microsoft Windows XP Embedded operating system
System memory: 1 GB
600 mHz ETX form factor embedded CPU
EDO-RAM 1.0 GB
Display Full visual graphic array (VGA)
Full active Thin Film Transistor (TFT)
800 × 600 resolution
Resistive touch screen
Interface 2 each USB 1.1
RAM RJ45 Ethernet port
Serial line RS232
PS2 keyboard
PS2 mouse
Internal barcode scanner
Optional external barcode scanner

12-9
12. Specifications ABL80 FLEX Operator’s Manual

Protocol High-level protocol:

RADIANCE/AQURE Data Management System
ASTM E1394-91
HL7 (versions 2.2 and 2.5)
Low-level serial protocol:
ASTM E1381-91
Low-level network protocol:
TCP/IP
Printer Thermal sensitive; Paper width: 80mm ±1.0
Power requirements 100–240 VAC, 50-60 Hz, 3 amps
Power supply fuse rating is 3.15 amps
CAUTION: Replace fuse only as marked to prevent fire
hazard.
Battery operation Approximately 1 hour of battery power when analyzer is in
standby mode
Battery pack charge time Approximately 1 hour, 20 minutes to fully charge a depleted
battery pack
Battery pack 4 lithium-ion cells
CAUTION: Use only Radiometer supplied battery pack.
Line cord For use with all ABL80 FLEX analyzer versions

12-10
ABL80 FLEX Operator’s Manual 12. Specifications

Approvals and compliances

Approvals UL, CSA. In compliance with IEC 61010-1 / EN 61010-1
CE mark

Indicates compliance with IVD Directive 98/79/EC when provided

with this manual.
ETL, Inc. The ABL80 FLEX and ABL80 FLEX CO-OX analyzers are Class I, Type
A, IPX0, continuous operating systems when connected to AC power and
internally powered when running off the batteries. The following symbol
represents ETL listing.

ABL80 FLEX, ABL80 FLEX CO-OX CONFORMS TO

UL STD 60601-1; CERTIFIED TO CAN/CSA C22.2 NO. 601.1 3081553
EMC Compliance To maintain EMC compliance use shielded cables for the Ethernet and
Communications ports. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to other devices in the
vicinity. However, there is no guarantee that interference will not occur in
a particular installation. If this equipment does cause harmful interference
to other devices, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving device. Increase the separation
between the equipment.
• Connect the equipment into an outlet on a circuit different from that
which the other device(s) are connected.
Consult your Service Representative for assistance.
EMI and EMC European Standards CISPR11/EN60601-1-2 Medical electrical equipment
Part 2: Collateral standard: Electromagnetic compatibility – requirements
and tests
IEC IEC 60601-1 Medical electrical equipment Part 1: General requirements
for safety
Accessories equipment connected to the analog and digital interfaces must
be certified to the respective IEC standards (i.e. IEC 60950 for data
processing equipment and IEC 60601-1 for medical equipment).
Furthermore all configurations shall comply with the system standard IEC
60601-1-1. Everybody who connects additional equipment to the signal
input part or signal output part configures a medical system, and is
therefore, responsible that the system complies with the requirements of
the system standard IEC 60601-1-1. If in doubt, consult your Service
Representative.
IEC/EN 61010-1 IEC 61010-1 1993+A2:1995 Safety requirements for electrical equipment
for measurement, control and laboratory use Part 1: General requirements

12-11
12. Specifications ABL80 FLEX Operator’s Manual

IEC Compliance The IEC 529 standard is not applicable to the ABL80 FLEX analyzer.
Therefore, the product classification for ingress of liquid protection is
IPX0.
IEC/EN 61010-2-010 Safety requirements for electrical equipment for measurement, control,
and laboratory use Part 2-010: Particular requirements for laboratory
equipment for the heating of materials
IEC/EN 61010-2-081 IEC 61010-2-081:2001/EN 61010-2-81 Safety requirements for electrical
equipment for measurement, control, and laboratory use Part 2-081:
Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes
IEC/EN 61010-2-101 IEC 61010-2-101:2002/ EN 61010-2-101 Part 2: Particular requirements
for in vitro diagnostic (IVD) medical equipment
IEC 61010-1:2001 ed.2
Waste of Electrical and
Electronic Equipment
(WEEE)
The symbol shows that:
• Radiometer Medical ApS and its distributors within the European Union
(EU) and associated states have taken the necessary steps to comply with
the directive, 2002/96/EC on waste electrical and electronic equipment
(WEEE).
• The instrument, when reaching its end of life, must be collected and
recycled separately from other waste according to national requirements.
Please contact your local Radiometer distributor for instructions.
Environmental implications:
WEEE contains materials that are potentially hazardous to the
environment and to human health.

12-12
ABL80 FLEX Operator’s Manual 12. Specifications

Symbols list
Symbols The symbols appearing on the analyzer and/or its consumables are identified
below.
SYMBOL FUNCTION
See operator’s manual for instructions

• ATTENTION: Consult operator’s manual

! • CAUTION: Electrical shock hazard do not remove panels
refer servicing to qualified service personnel
• DANGER: Possible explosion hazard if used in the presence
of flammable anesthetics
• Battery replacement by factory trained personnel only
In-Vitro Diagnostic device
IVD
CD drive access

Internal barcode reader

System reset button

System power on/off button

Mouse connection

Barcode scanner / keyboard port

Video in connection

COM 1 port
Ethernet interface connection to network. Not for phone
connection.

Marks compliance with SJ/T 11363-2006 (China RoHS). The

number in the symbol shows the environmentally friendly use
period in years.

Marks compliance with SJ/T 11363-2006 (China RoHS). The

number in the symbol shows the environmentally friendly use
period in years.

12-13
12. Specifications ABL80 FLEX Operator’s Manual

SYMBOL FUNCTION
USB connection

Cooling fan

Power switch — On

Power switch — Standby

Alternating current
Main power specifications including fuse information

Electrical power connection.

Bi-directional rotation

Trim edge of paper roll before inserting into analyzer

SN Serial number

REF Reference number (Reorder number)

LOT Lot number

~n~ tests per device

n
Temperature range

Install by date

Use by date (Expiration date)

Fragile, handle with care

Refrigeration required

12-14
ABL80 FLEX Operator’s Manual 12. Specifications

Patents
Patents Radiometer products may be covered by one or more patents and patent
applications. See http://www.radiometer.com/en/legal/patents.

12-15
12. Specifications ABL80 FLEX Operator’s Manual

12-16
 13. Order information

Introduction This chapter provides the part numbers and ordering information for accessories
used on all versions of the ABL80 FLEX analyzer.
The following accessories can be ordered through your local Radiometer
representative.

Contents This chapter contains the following topics.

ABL80 FLEX analyzer ........................................................................13-2
ABL80 FLEX CO-OX analyzer...........................................................13-5
Accessories...........................................................................................13-7
Documentation .....................................................................................13-9
Samplers .............................................................................................13-10
13. Order information ABL80 FLEX Operator’s Manual

ABL80 FLEX analyzer

Accessories – Item REF
ABL80 FLEX
ABL80 FLEX analyzer 393-839
analyzer
Solution pack 944-174
Sensor cassette 25 tests / 30 days Full panel QC3 945-768
3
Sensor cassette 50 tests / 30 days Full panel QC 945-665
3
Sensor cassette 100 tests / 30 days Full panel QC 945-666
Sensor cassette 200 tests / 30 days Full panel QC3 945-667
3
Sensor cassette 300 tests / 30 days Full panel QC 945-668
Sensor cassette 300 tests / 15 days Full panel QC3 945-669
3
Sensor cassette 25 tests / 30 days Full panel, no Glu QC 945-769
Sensor cassette 50 tests / 30 days Full panel, no Glu QC3 945-670
3
Sensor cassette 100 tests / 30 days Full panel, no Glu QC 945-671
3
Sensor cassette 200 tests / 30 days Full panel, no Glu QC 945-672
3
Sensor cassette 300 tests / 30 days Full panel, no Glu QC 945-673
3
Sensor cassette 300 tests / 15 days Full panel, no Glu QC 945-674
Sensor cassette 25 tests / 30 days BG/Hct QC3 945-770
3
Sensor cassette 50 tests / 30 days BG/Hct QC 945-675
Sensor cassette 100 tests / 30 days BG/Hct QC3 945-676
3
Sensor cassette 200 tests / 30 days BG/Hct QC 945-677
Sensor cassette 300 tests / 30 days BG/Hct QC3 945-678
3
Sensor cassette 300 tests / 15 days BG/Hct QC 945-679

13-2
ABL80 FLEX Operator’s Manual 13. Order information

Item REF
3
Sensor cassette 25 tests / 30 days Full panel no QC 945-771
Sensor cassette 50 tests / 30 days Full panel no QC3 945-680
3
Sensor cassette 100 tests / 30 days Full panel no QC 945-681
Sensor cassette 200 tests / 30 days Full panel no QC3 945-682
3
Sensor cassette 300 tests / 30 days Full panel no QC 945-683
Sensor cassette 300 tests / 15 days Full panel no QC3 945-684
3
Sensor cassette 25 tests / 30 days Full panel, no Glu no QC 945-772
3
Sensor cassette 50 tests / 30 days Full panel, no Glu no QC 945-685
Sensor cassette 100 tests / 30 days Full panel, no Glu no QC3 945-686
3
Sensor cassette 200 tests / 30 days Full panel, no Glu no QC 945-687
Sensor cassette 300 tests / 30 days Full panel, no Glu no QC3 945-688
3
Sensor cassette 300 tests / 15 days Full panel, no Glu no QC 945-689
Sensor cassette 25 tests / 30 days BG/Hct no QC3 945-773
3
Sensor cassette 50 tests / 30 days BG/Hct no QC 945-690
Sensor cassette 100 tests / 30 days BG/Hct no QC3 945-691
3
Sensor cassette 200 tests / 30 days BG/Hct no QC 945-692
3
Sensor cassette 300 tests / 30 days BG/Hct no QC 945-693
Sensor cassette 300 tests / 15 days BG/Hct no QC3 945-694

13-3
13. Order information ABL80 FLEX Operator’s Manual

Accessories – Item REF

ABL80 FLEX
Solution pack 944-309
analyzer with
BASIC software Solution pack with lactate 944-383
configuration Sensor cassette 25 tests / 60 days Full panel 945-774
Sensor cassette 50 tests / 60 days Full panel 945-775
Sensor cassette 100 tests / 60 days Full panel 945-776
Sensor cassette 200 tests / 60 days Full panel 945-777
Sensor cassette 300 tests / 60 days Full panel 945-778
Sensor cassette 300 tests / 30 days Full panel 945-779
Sensor cassette 300 tests / 15 days Full panel 945-780
Sensor cassette 600 tests / 15 days Full panel 945-783
Sensor cassette 25 Tests /30 Days Full Panel with Lac 945-808
Sensor cassette 50 Tests / 30 Days Full Panel with Lac 945-809
Sensor cassette 100 Tests / 30 Days Full Panel with Lac 945-810
Sensor cassette 200 Tests / 30 Days Full Panel with Lac 945-811
Sensor cassette 300 Tests / 30 Days Full Panel with Lac 945-812
Sensor cassette 300 Tests / 15 Days Full Panel with Lac 945-813
Sensor cassette 600 Tests / 15 Days Full Panel with Lac 945-814
Sensor cassette 25 tests / 60 days BG/Hct 945-784
Sensor cassette 50 tests / 60 days BG/Hct 945-785
Sensor cassette 100 tests / 60 days BG/Hct 945-786
Sensor cassette 200 tests / 60 days BG/Hct 945-787
Sensor cassette 300 tests / 60 days BG/Hct 945-788
Sensor cassette 300 tests / 30 days BG/Hct 945-789
Sensor cassette 300 tests / 15 days BG/Hct 945-790
Sensor cassette 600 tests / 15 days BG/Hct 945-793

13-4
ABL80 FLEX Operator’s Manual 13. Order information

ABL80 FLEX CO-OX analyzer

Accessories – Item REF
ABL80 FLEX
ABL80 FLEX CO-OX analyzer 393-841
CO-OX
analyzer Solution pack CO-OX 944-252
Sensor cassette 25 tests / 30 days Full panel CO-OX QC3 945-700
3
Sensor cassette 50 tests / 30 days Full panel CO-OX QC 945-701
3
Sensor cassette 100 tests / 30 days Full panel CO-OX QC 945-702
Sensor cassette 200 tests / 30 days Full panel CO-OX QC3 945-703
3
Sensor cassette 300 tests / 30 days Full panel CO-OX QC 945-704
Sensor cassette 300 tests / 15 days Full panel CO-OX QC3 945-705
3
Sensor cassette 25 tests / 30 days Full panel CO-OX, no Glu QC 945-706
Sensor cassette 50 tests / 30 days Full panel CO-OX, no Glu QC3 945-707
3
Sensor cassette 100 tests / 30 days Full panel, CO-OX no Glu QC 945-708
3
Sensor cassette 200 tests / 30 days Full panel, CO-OX no Glu QC 945-709
3
Sensor cassette 300 tests / 30 days Full panel, CO-OX no Glu QC 945-710
3
Sensor cassette 300 tests / 15 days Full panel, CO-OX no Glu QC 945-711
Sensor cassette 25 tests / 30 days BG/CO-OX QC3 945-712
3
Sensor cassette 50 tests / 30 days BG/CO-OX QC 945-713
Sensor cassette 100 tests / 30 days BG/CO-OX QC3 945-714
3
Sensor cassette 200 tests / 30 days BG/CO-OX QC 945-715
Sensor cassette 300 tests / 30 days BG/CO-OX QC3 945-716
3
Sensor cassette 300 tests / 15 days BG/CO-OX QC 945-717

13-5
13. Order information ABL80 FLEX Operator’s Manual

Item REF
3
Sensor cassette 25 tests / 30 days Full panel CO-OX no QC 945-718
Sensor cassette 50 tests / 30 days Full panel CO-OX no QC3 945-719
3
Sensor cassette 100 tests / 30 days Full panel CO-OX no QC 945-720
Sensor cassette 200 tests / 30 days Full panel CO-OX no QC3 945-721
3
Sensor cassette 300 tests / 30 days Full panel CO-OX no QC 945-722
Sensor cassette 300 tests / 15 days Full panel CO-OX no QC3 945-723
3
Sensor cassette 25 tests / 30 days Full panel CO-OX, no Glu no QC 945-724
3
Sensor cassette 50 tests / 30 days Full panel CO-OX, no Glu no QC 945-725
Sensor cassette 100 tests / 30 days Full panel, CO-OX no Glu no QC3 945-726
3
Sensor cassette 200 tests / 30 days Full panel, CO-OX no Glu no QC 945-727
Sensor cassette 300 tests / 30 days Full panel, CO-OX no Glu no QC3 945-728
3
Sensor cassette 300 tests / 15 days Full panel, CO-OX no Glu no QC 945-729
Sensor cassette 25 tests / 30 days BG/CO-OX no QC3 945-730
3
Sensor cassette 50 tests / 30 days BG/CO-OX no QC 945-731
Sensor cassette 100 tests / 30 days BG/CO-OX no QC3 945-732
3
Sensor cassette 200 tests / 30 days BG/CO-OX no QC 945-733
3
Sensor cassette 300 tests / 30 days BG/CO-OX no QC 945-734
Sensor cassette 300 tests / 15 days BG/CO-OX no QC3 945-735

Accessories – Item REF

ABL80 FLEX
Solution pack 944-341
CO-OX
analyzer with Sensor cassette 200 tests / 60 days 945-843
OSM software 600 tests / 60 days 945-806
configuration

13-6
ABL80 FLEX Operator’s Manual 13. Order information

Accessories
General Item REF
accessories
Thermal printer paper, 6 rolls 984-077
Barcode scanner, external 902-994
Barcode scanner holder 924-572
Touch screen stylet pen 902-667
Cleaning solution (sodium hypochlorite) 943-906
ABL80 FLEX fluid path obstruction kit 905-674
ABL80 FLEX CO-OX fluidics kit 905-889
Remote Support key 902-583

Line cords Item REF

Line cord 240 V European 615-319
Line cord 240 V United Kingdom 615-320
Line cord 240 V Italy 615-321
Line cord 240 V Denmark 615-322
Line cord 240 V Israel 615-323
Line cord 240 V Switzerland 615-324
Line cord 240 V Australia / New Zealand 615-325
Line cord 240 V South Africa / India 615-326
Line cord 120 V USA / Japan 615-406

13-7
13. Order information ABL80 FLEX Operator’s Manual

Quality Control Item REF

S7430 QUALICHECK4+ level 1 (box of 30 ampoules) 944-053
S7440 QUALICHECK4+ level 2 (box of 30 ampoules) 944-054
S7450 QUALICHECK4+ level 3 (box of 30 ampoules) 944-055
S7460 QUALICHECK4+ level 4 (box of 30 ampoules) 944-056
S7170 HEMATOCRIT AND METABOLITE level 1 944-039
S7180 HEMATOCRIT AND METABOLITE level 2 944-040
S7730 QUALICHECK5+ level 1 (box of 30 ampoules) 944-017
S7740 QUALICHECK5+ level 2 (box of 30 ampoules) 944-018
S7750 QUALICHECK5+ level 3 (box of 30 ampoules) 944-019
S7760 QUALICHECK5+ level 4 (box of 30 ampoules) 944-020
S7930 Range+ QUALICHECK, Level 1 944-151
S7940 Range+ QUALICHECK, Level 2 944-152
S7950 Range+ QUALICHECK, Level 3 944-153
S7770 ctHb Calibration Solution 944-021
QUALICHECK+ tray (Celsius) 887-860
Ampoule opener 920-712
QC reference manual, English 989-046
QC short-form instructions, English 989-313
Logbook binder for control charts 984-129
Control charts - blood gas 989-417
Control charts - electrolytes and metabolites 989-418

13-8
ABL80 FLEX Operator’s Manual 13. Order information

Documentation
Manuals Item REF
Operator’s manual, ABL80 FLEX analyzer, English 996-075
Reference manual, ABL80 FLEX analyzer, English 996-074

13-9
13. Order information ABL80 FLEX Operator’s Manual

Samplers
Syringe Item REF
samplers
PICO70 syringe without needle 956-518
PICO70 syringe without needle, without needle cube 956-519
PICO70 22G x 1” 956-522
PICO70 22G x 1¼” 956-525
PICO70 23G x 5/8” 956-529
PICO70 23G x 1” 956-533
PICO70 23G x 1¼” 956-534
PICO70 23G x 5/8” without needle cube 956-546
PICO70 25G x 5/8” 956-547
PICO70 22G x 1” without needle cube 956-563
PICO50 (2ml) aspiration syringe 956-552
* safePICO Self-fill without needle with safeTIPCAP, 0.7-1.5 mL 956-610
(100 units)
safePICO Self-fill with safeTIPCAP, without needle shield device, 956-611
22G x 1 ¼“, 0.7-1.5 mL (100 units)
safePICO Self-fill with safeTIPCAP, without needle shield device, 956-612
23G x 5/8”, 0.7-1.5 mL (100 units)
safePICO Self-fill with safeTIPCAP, without needle shield device, 956-613
22G x 1”, 0.7-1.5 mL (100 units)
* safePICO Self-fill with needle shield device and safeTIPCAP, 956-614
22G x 1 ¼“, 0.7-1.5 mL (100 units)
* safePICO Self-fill with needle shield device and safeTIPCAP, 956-615
23G x 5/8”, 0.7-1.5 mL (100 units)
* safePICO Self-fill with needle shield device and safeTIPCAP, 956-616
23G x 1”, 0.7-1.5 mL (100 units)
* safePICO Self-fill with needle shield device and safeTIPCAP, 956-620
22G x 1”,, 0.7-1.5 mL (100 units)
* safePICO Self-fill with needle shield device and safeTIPCAP, 956-623
25G x 5/8”, 0.7-1.5 mL (100 units)
* safePICO Aspirator, aspiration syringe, 0.7-1.5 mL (100 units) 956-622
*Without a needle cube

13-10
ABL80 FLEX Operator’s Manual 13. Order information

Capillary tube Item REF

samplers
safeCLINITUBES (plastic):
D957P-70-70x1 70 µL 70 IU balanced heparin 250 each 942-898
D941P-NA-240-85 × 1 85 µL 240 IU sodium heparin 250 each 942-890
D941P-NA-240-85 × 3 85 µL 240 IU sodium heparin 750 each 942-891
D957P-70-100 × 1 100 µL 70 IU balanced heparin 250 each 942-892
D957P-70-125 × 1 125 µL 70 IU balanced heparin 250 each 942-893
CLINITUBES (glass):
D941G-240-85 × 5 85 µL 240 IU sodium heparin 375 each 942-875
D941G-NA-240-85×10 85 µL 240 IU sodium heparin 750 each 942-876
D956G-70-100 × 1 100 µL 70 IU balanced heparin 75 each 905-663
D957G-70-100 × 5 100 µL 70 IU balanced heparin 375 each 942-878
D956G-70-125× 1 125 µL 70 IU balanced heparin 50 each 905-664
D957G-70-125 × 5 125 µL 70 IU balanced heparin 250 each 942-680
D956G-70-210 × 1 210 µL 70 IU balanced heparin 50 each 905-666
D957G-70-210 × 5 210 µL 70 IU balanced heparin 250 each 942-884
Accessories:
Capillary sampling adapters (ABL80 FLEX analyzer) 906-022
Capillary sampling adapters (ABL80 FLEX CO-OX analyzer) 906-025

NOTE: Balanced heparin should always be used when measuring electrolyte

values. Sodium heparin use should be restricted to blood gas measurements only.

safePICO mixer Item REF

safePICO mixer with power adapter UK 903-046
safePICO mixer with power adapter US 903-047
safePICO mixer with power adapter EU 903-048
safePICO mixer with power adapter AUS/JP 903-049

13-11
13. Order information ABL80 FLEX Operator’s Manual

13-12
 Index

A
Acceptance criteria ............................................................................................................ 6-2
Accessories....................................................................................................................... 13-7
Active parameters ............................................................................................................ 9-72
Add a user ........................................................................................................................ 9-81
Air contamination .......................................................................................................... 10-23
Air detection .................................................................................................................... 9-75
Analysis Check .................................................................................................................... 6-7
Analyzer front view ............................................................................................................ 2-2
Analyzer lockout .............................................................................................................. 9-77
Analyzer message ..................................................................................................... 3-3, 9-41
Analyzer power ................................................................................................................ 2-13
Power down the analyzer ............................................................................................ 2-14
Power up the analyzer ................................................................................................. 2-13
Analyzer rear view ............................................................................................................. 2-4
Analyzer Status .................................................................................................................. 3-5
Animal blood ...................................................................................................................... 1-2
Anticoagulant ................................................................................................................... 11-3
Approval .................................................................................................................. 4-25, 9-37
Approvals and compliances ........................................................................................... 12-11
Automatic QC plot ............................................................................................................. 6-3
Automatic QC statistics ...................................................................................................... 6-5
Automatic quality control .................................................................................................. 6-2
B
Barcode scanning ............................................................................................................. 4-17
Battery indicators .......................................................................................................... 10-62
Battery life ..................................................................................................................... 10-62
Battery management ..................................................................................................... 10-62
Battery replacement ...................................................................................................... 10-63
Charge time ............................................................................................................... 10-62
LED indicators ............................................................................................................ 10-64
Sleep mode ................................................................................................................ 10-64
C
Calculated parameters ..................................................................................................... 12-4
Calibration.......................................................................................................................... 5-1
Calibration reports ............................................................................................................. 5-4
Capillary sampling guidelines ........................................................................................... 11-7
Capillary sampling sites .................................................................................................... 11-7
Causes of errors in the preanalytical phase ..................................................................... 11-2
Cell sedimentation ........................................................................................................... 11-2
Centralized User Management ........................................................................................ 9-79
Cleaning and disinfection ............................................................................................... 10-10
CLINITUBES ...................................................................................................................... 11-9
Control ranges.................................................................................................................... 6-2
CO-OX error codes ......................................................................................................... 10-53
CO-oximeter troubleshooting ........................................................................................ 10-26
Corrective action ................................................................................................................ 6-6
Correlation ....................................................................................................................... 9-44

1
Index ABL80 Operator's Manual

Correlation modes ....................................................................................................... 9-44

Enter correlation values .............................................................................................. 9-46
Input ranges................................................................................................................. 9-45
Counter .............................................................................................................................. 8-7
Critical limits ............................................................................................................. 4-14, 9-5
Cuvette factor .................................................................................................................... 5-8
Cycle time ........................................................................................................................ 12-8
D
Data communications ...................................................................................................... 9-29
Data logs ............................................................................................................................ 7-1
Download ...................................................................................................................... 7-8
Logs ................................................................................................................................ 7-4
Upload ........................................................................................................................... 7-5
Data maintenance ............................................................................................................ 7-11
Data request .................................................................................................................... 9-35
Date/time ......................................................................................................................... 9-26
Derived parameters .................................................................................................. 1-4, 12-4
Dilution of sample ............................................................................................................ 11-3
Disable Analysis................................................................................................................ 9-11
Disinfection procedure .................................................................................................. 10-12
Documentation ................................................................................................................ 13-9
Download ........................................................................................................................... 7-8
Download setup ............................................................................................................... 9-71
Drift ........................................................................................................................... 5-2, 9-22
E
Edit log ........................................................................................................... 4-21, 4-22, 4-24
Edit patient information ........................................................................................... 4-21, 7-4
Eject CD ............................................................................................................................ 8-14
Error messages............................................................................................................... 10-33
Air detection .............................................................................................................. 10-46
Manual QC ................................................................................................................. 10-49
Oximeter .................................................................................................................... 10-51
Sensor cassette .......................................................................................................... 10-41
Solution pack ............................................................................................................. 10-38
System errors ............................................................................................................ 10-33
Temperature .............................................................................................................. 10-46
F
Failure report ................................................................................................................... 3-10
Fetal hemoglobin correction............................................................................................ 4-20
FlexLink ................................................................................................................... 4-27, 9-39
Fluidics ............................................................................................................................. 10-5
G
General error messages ................................................................................................. 10-33
Groups - security .............................................................................................................. 9-83
Guide ....................................................................................................................... 2-11, 2-12
Guidelines ........................................................................................................................ 10-4
H
Header ............................................................................................................................. 9-70
Hemolysis ......................................................................................................................... 11-2
Heparin interference........................................................................................................ 11-3
HIS/LIS .............................................................................................................................. 9-33
Human blood ..................................................................................................................... 1-2

2
ABL80 FLEX operator's manual Index

I
Icons ................................................................................................................................. 3-13
Inlet flap .................................................................................................................... 2-9, 2-10
Inlet handle ............................................................................................................. 2-11, 2-12
Inlet probe ................................................................................................................ 2-9, 2-11
Input fields ..................................................................................................... 4-16, 4-19, 9-53
Input parameters ............................................................................................................. 12-7
Install by date................................................................................................... 2-5, 2-10, 2-12
Installation
Sensor cassette .............................................................................................................. 8-2
Solution pack ................................................................................................................. 8-5
Intended use ...................................................................................................................... 1-2
interfering substances ..................................................................................................... 1-10
Introducing a blood sample ............................................................................................... 4-3
L
Labels ............................................................................................................................... 9-70
Limitations of use ............................................................................................................. 1-12
Lockout ............................................................................................................................ 9-11
Logistics ............................................................................................................................ 9-39
Logs .................................................................................................................................... 7-4
Lot number ............................................................................................................... 2-7, 2-10
M
Main menu ......................................................................................................................... 3-3
Main menu setup .................................................................................................... 3-17, 9-49
Mandatory ....................................................................................................................... 9-79
Manual eject .................................................................................................................... 8-14
Manual quality control................................................................................................ 6-8, 9-7
Level detection failure ................................................................................................. 6-13
Lockout ........................................................................................................................ 9-11
Out of range manual QC results .................................................................................. 6-16
Performing a manual QC measurement ...................................................................... 6-10
Plot .............................................................................................................................. 6-17
Preparing manual QC solutions ..................................................................................... 6-9
QC ranges ...................................................................................................................... 9-8
Ranges ........................................................................................................................... 9-8
Results ......................................................................................................................... 6-15
Results out of range................................................................................................... 10-28
Reviewing manual QC statistics ................................................................................... 6-19
Schedule ...................................................................................................................... 9-14
Statistical factor ........................................................................................................... 9-13
Temperature ......................................................................................................... 6-9, 9-17
Measured parameters .............................................................................................. 1-2, 12-2
Measuring range .............................................................................................................. 12-2
Multiple parameters out of range ................................................................................. 10-22
N
Network settings .............................................................................................................. 9-29
NIST traceable ............................................................................................................. 2-6, 2-7
3
Non-QC sensor cassette ................................................................................................. 9-21
3
Non-QC systems ................................................................................................. 5-2, 7-2, 7-8
O
Operating specifications .................................................................................................. 12-8
Options............................................................................................................................. 9-70

3
Index ABL80 Operator's Manual

Order information ............................................................................................................ 13-1

Out of range suppression ................................................................................................. 4-20
P
Parameter bar ............................................................................................................. 3-3, 3-6
Parameter Panel ................................................................................................ 4-4, 4-5, 9-56
Patents ........................................................................................................................... 12-15
Patient edit log ................................................................................................................. 4-24
Patient information query ............................................................................................... 4-15
Patient input fields ........................................................................................................... 4-16
Patient ranges .................................................................................................................... 9-2
Patient report .................................................................................................................. 4-20
Patient types ...................................................................................................................... 9-3
Critical limits .................................................................................................................. 9-5
Reference ranges ........................................................................................................... 9-4
Reportable range ........................................................................................................... 9-5
Physical specifications...................................................................................................... 12-8
PICO50 ............................................................................................................................. 11-8
PICO70 ............................................................................................................................. 11-8
Plot ................................................................................................................... 6-3, 6-15, 6-17
Possible sources of air contamination ........................................................................... 10-23
Preanalytical phase .......................................................................................................... 11-2
Preparation prior to arterial/venous sampling ................................................................ 11-5
Preparation prior to capillary sampling ........................................................................... 11-7
Pre-registration ................................................................................................................ 9-40
Print queue ...................................................................................................................... 2-15
Printer paper installation ................................................................................................. 2-15
Q
QA Portal .......................................................................................................................... 9-36
QC results out of range .................................................................................................. 10-28
QUALICHECK 4+ Control Solution ...................................................................................... 6-8
QUALICHECK 5+ Control Solution ...................................................................................... 6-8
Quality management ......................................................................................................... 6-1
Query ............................................................................................................................... 4-15
Quick keys ................................................................................................................. 3-3, 9-50
R
RADIANCE/AQURE connection active .............................................................................. 3-20
RADIANCE/AQURE connection not active ....................................................................... 3-20
RADIANCE/AQURE system ........................................................................................ 3-3, 9-31
Range+ QUALICHECK Control Solution ............................................................................ 6-20
Record deletion................................................................................................................ 9-48
Reference ranges ............................................................................................... 4-14, 9-2, 9-4
References ..................................................................................................................... 11-13
Release latch ............................................................................................................. 2-9, 2-11
Remote support ............................................................................................................... 9-37
Remove a user ................................................................................................................. 9-82
Replacements
Sensor cassette replacement ........................................................................................ 8-2
Solution pack replacement ............................................................................................ 8-5
Reportable ranges ..................................................................................................... 4-14, 9-6
Reports ............................................................................................................................. 9-52
Input fields ................................................................................................................... 9-53
Patient download ........................................................................................................ 9-71
Printout........................................................................................................................ 9-69
Report options ............................................................................................................. 9-69

4
ABL80 FLEX operator's manual Index

Result messages ............................................................................................................. 10-58

Retain ............................................................................................................................... 9-79
RiliBÄK ranges ......................................................................................................... 6-22, 9-19
Rinse................................................................................................................................. 8-12
S
safePICO ........................................................................................................................... 11-8
safePICO mixer ............................................................................................................... 13-11
Sample Analysis ................................................................................................................. 4-3
Sample information ......................................................................................................... 4-15
Sample measurements ...................................................................................................... 4-1
Sample mixing .................................................................................................................... 4-2
Sample size ........................................................................................................................ 4-2
Sample type ..................................................................................................................... 12-8
Sample types ............................................................................................................. 4-2, 11-5
Sample volume ................................................................................................................ 12-8
Samplers ............................................................................................................... 11-8, 13-10
Sampling devices.............................................................................................................. 11-8
Sampling guidelines ................................................................................................ 11-6, 11-7
Sampling procedures ..................................................................................................... 11-12
Sampling sites .................................................................................................................. 11-7
SC80 ................................................................................................................................... 2-8
SC80 CO-OX ........................................................................................................................ 2-8
Schedule
Manual QC ................................................................................................................... 9-14
System Cycle ................................................................................................................ 9-21
Security
Add a user .................................................................................................................... 9-81
Expirations ................................................................................................................... 9-85
Groups ......................................................................................................................... 9-83
Remove a user ............................................................................................................. 9-82
Users tab...................................................................................................................... 9-81
Security ............................................................................................................................ 9-78
Logon tab ..................................................................................................................... 9-78
Sensor cassette front and rear views ................................................................................. 2-8
Sensor window.......................................................................................................... 2-9, 2-11
Settings transfer ................................................................................................................. 8-9
Transfer from disk ......................................................................................................... 8-9
Transfer to disk .............................................................................................................. 8-9
Simplified main menu ...................................................................................................... 9-49
Single parameter out of range ....................................................................................... 10-20
Software upgrade ............................................................................................................ 8-13
Solution pack ..................................................................................................................... 2-5
SP80 ................................................................................................................................... 2-5
SP80 CO-OX ........................................................................................................................ 2-5
Standby mode .................................................................................................................... 5-9
Standby schedule ............................................................................................................. 9-23
Storage ........................................................................................................................... 11-10
Symbols list .................................................................................................................... 12-13
System
Active parameters ....................................................................................................... 9-72
Air detection ................................................................................................................ 9-75
Analyzer lockout .......................................................................................................... 9-77
System Checks ................................................................................................................... 6-6
System Cycle drift ............................................................................................................ 9-22
System Cycle schedule ..................................................................................................... 9-21
System Cycle unsuccessful ............................................................................................. 10-13

5
Index ABL80 Operator's Manual

System information .................................................................................................. 3-6, 7-13

System messages ........................................................................................................... 10-30
System status ..................................................................................................... 3-4, 3-5, 9-42
T
Test range ........................................................................................................ 4-14, 9-2, 12-2
tHb calibration .......................................................................................................... 5-6, 8-11
tHb calibration schedule .................................................................................................. 9-25
Touch screen ...................................................................................................................... 3-2
Troubleshooting table .................................................................................................... 10-21
Tutorials ............................................................................................................... 3-3, 3-4, 3-8
Two-Point Calibration ........................................................................................................ 5-5
U
Units ................................................................................................................................. 9-27
Upload................................................................................................................................ 7-5
Utilities ............................................................................................................................... 8-1
W
Warnings and cautions ........................................................................................... 1-11, 10-3
WDC upload ....................................................................................................................... 7-6

6
ABL80 FLEX operator’s manual Date of issue

Date of issue

Radiometer representative: Manufacturer:

Radiometer Medical ApS

Åkandevej 21
2700 Brønshøj
If you have any questions or need assistance, please
Denmark
contact your local Radiometer representative.
www.radiometer.com

ABL80 FLEX
operator's manual
from ABL80 FLEX software
version: 3.10

Publication 201305
Edition C
Code number 996-075
ABL80 FLEX operator’s manual Date of issue