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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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ABL80 FLEX Operator's Manual 4. Sample measurement
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
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
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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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.
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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4. Sample measurement ABL80 FLEX Operator's Manual
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
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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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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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5. Calibration
Introduction This chapter describes the calibration concept and reporting format for all versions
of the ABL80 FLEX analyzer.
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.
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 FLEX software provides the option to install
systems sensor cassette versions that do not support the QC3 system. The calibration
process consists of a single two-point calibration only.
In these systems, the main menu provides a selection to initiate a manual two-point
calibration in place of a manual System Cycle.
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ABL80 FLEX Operator's Manual 5. Calibration
When using 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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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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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 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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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.
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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4. The system will complete a blank calibration then prompt the user to
aspirate the calibration solution.
• Press Aspirate.
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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 CO-OX analyzer with OSM software configuration includes 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 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 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.
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.
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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 is 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.
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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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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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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System Checks
Description Every 30 minutes the analyzer will perform a System Check to verify the stability
and proper function of the analyzer. 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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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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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 it is recommended to use the Radiometer brand
4+ Control quality control material QUALICHECK4+ for optimal performance and to take
Solution 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.
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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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.
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.
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Introduction This topic describes the procedure for performing manual quality control
measurements on all ABL80 FLEX analyzer versions.
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.
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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).
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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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ABL80 FLEX Operator's Manual 6. Quality management
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
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6. Quality management ABL80 FLEX Operator's Manual
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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ABL80 FLEX Operator's Manual 6. Quality management
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
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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6. Quality management ABL80 FLEX Operator's Manual
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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ABL80 FLEX Operator's Manual 6. Quality management
Printout of
statistics Press the print icon to obtain a printout of the reported statistics.
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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6. Quality management ABL80 FLEX Operator's Manual
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 Operator's Manual 6. Quality management
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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6. Quality management ABL80 FLEX Operator's Manual
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.
General information
Introduction All ABL80 FLEX analyzer versions contain the following data logs:
• Patient
• Manual QC
• System Cycle
• 2-point cal
• System Check
• 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.
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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.
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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.
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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
• 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
• 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.
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.
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ABL80 FLEX Operator's Manual 7. Data logs
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.
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)
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7. Data logs ABL80 FLEX Operator's Manual
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.
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Schedule data Follow the steps below to schedule a specific time for automatic data maintenance.
maintenance
Step Action
1. Select Menu Data Maintenance Schedule.
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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
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
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.
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
• If the cassette version to be installed has an inlet cap, the cap must
be removed before installing the cassette on the analyzer
• 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
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
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
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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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:
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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.
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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 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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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.
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ABL80 FLEX Operator's Manual 8. Utilities
Software upgrade
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 or connect a USB drive containing the software
upgrade file from Radiometer.
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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Eject CD
Introduction Some analyzers contain 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
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.
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).
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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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.
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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.
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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
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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
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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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.
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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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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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9. Settings ABL80 FLEX Operator's Manual
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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ABL80 FLEX Operator's Manual 9. Settings
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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ABL80 FLEX Operator's Manual 9. Settings
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 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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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 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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ABL80 FLEX Operator's Manual 9. Settings
Standby schedule
Introduction The Standby Schedule screen is available only on 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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9. Settings ABL80 FLEX Operator's Manual
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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ABL80 FLEX Operator's Manual 9. Settings
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.
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9. Settings ABL80 FLEX Operator's Manual
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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ABL80 FLEX Operator's Manual 9. Settings
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
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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9. Settings ABL80 FLEX Operator's Manual
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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ABL80 FLEX Operator's Manual 9. Settings
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
• Approval – to enable the approval of results prior to transmission to an HIS/LIS
system
• LIVE Connect – to provide a network connection to send analyzer data to
Radiometer (Data Acquisition) and/or to enable Remote Support which allows
external control of the analyzer, for use by Radiometer service personnel
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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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.
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ABL80 FLEX Operator's Manual 9. Settings
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
• 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.
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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.
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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.
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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LIVE Connect The LIVE Connect tab allows the user to enable two features
• Data Acquisition – sends analyzer data to Radiometer for pro-active
monitoring and support of the analyzer. For patient privacy, patient
information is not transmitted.
• Remote Support – provides the ability for a Radiometer service
representative to manage and service the analyzer remotely. For patient
privacy, patient logs are not accessible by the remote user.
Follow the steps below to enable these features and configure settings.
Step Action
1. Select the LIVE Connect tab on the Data Communications screen.
2. Press the Enable check box within the Data Acquisition group box to
enable this feature.
3. Press the Enable check box within the Remote Support group box to
enable this feature.
4. Press Select Country to select the country within which this analyzer
is located then press OK.
5. Press the Disconnect remote operator when Analysis or Manual
QC is initiated check box to disconnect an external user from the
analyzer when either Analysis or Manual QC is selected from the
main menu.
6. Press OK to store all settings.
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ABL80 FLEX Operator's Manual 9. Settings
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).
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.
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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.
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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
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.
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.
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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.
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.
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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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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.
3. When enabled, the main menu will appear as shown here:
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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.
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
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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
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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
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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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.
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.
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• 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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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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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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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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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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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.
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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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9. Settings ABL80 FLEX Operator's Manual
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.
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ABL80 FLEX Operator's Manual 9. Settings
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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ABL80 FLEX Operator's Manual 9. Settings
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.
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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.
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
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: 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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10. Troubleshooting ABL80 FLEX Operator’s Manual
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
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
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).
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10. Troubleshooting ABL80 FLEX Operator’s Manual
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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10. Troubleshooting ABL80 FLEX Operator’s Manual
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.
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.
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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.
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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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10. Troubleshooting ABL80 FLEX Operator’s Manual
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.
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
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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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
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
MESSAGES
Status: pCO2
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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
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
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
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
MESSAGES
Status: pH, pCO2, cCa2+
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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
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
MESSAGES
Status: pH, pCO2, pO2
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10. Troubleshooting ABL80 FLEX Operator’s Manual
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)
Replace SC80
Sensitivity
out-of-range
pO2 Replace SP Replace SC80
QC out-of-
range
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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
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
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
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.
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
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
MESSAGES
Status: ? ctHb
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10. Troubleshooting ABL80 FLEX Operator’s Manual
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) 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.
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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.
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
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
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10. Troubleshooting ABL80 FLEX Operator’s Manual
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 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.
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ABL80 FLEX Operator’s Manual 10. Troubleshooting
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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10. Troubleshooting ABL80 FLEX Operator’s Manual
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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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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