RADIOMETER FLEX ABL90 Setup guide

Operator Training Guide
ABL90 FLEX analyzer
1 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

2
Operator training
Even a simple process or task can become erroneous and complicated without proper and
relevant training. To ensure satisfaction and efficient use of this Radiometer product we
offer a range of training materials.
ABL90 FLEX analyzer Operator Training Guide
The operator training guide is a supporting tool for the person training the operators
of the device. The guide includes information on how to handle various processes and
tasks related to the device. The information is given in short bullet point statements,
illustrations and photos serving as trigger points for the trainer. In addition, there are
suggestions as to when a task should be demonstrated by the trainer and when it should
be performed hands-on by the operator.
Training materials offered for operator training:
• Online training courses suitable for self-study by the operator as preparation for face-to-
face training or refresher training
• Competency tests to assess operator competency (offered both offline and online)
Other training material:
• Blood Gas Handbook
• Blood Gas – Preanalytics
Handbooks can be downloaded from www.MyRadiometer.com, from the customer
portal or via www.Radiometer.com as mobile applications for smart phones and tablets.
2 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

Index
1. What is what 4
2. Syringe samples – preanalytical errors 5-6
3. Syringe samples – how to measure a patient sample 7-9
4. Capillary samples – preanalytical errors 10-11
5. Capillary samples – how to measure a patient sample 12-14
6. Consumables 15
7. Changing consumables 16-18
8. Troubleshooting 19
9. General information 20
10. Key Operator Training 21
11. Replacements 22-23
12. Clean the analyzer 24
13. Troubleshooting and guide 25
14. Quality control and calibrations 26-28
15. Theoretical aspects of the blood gas analyzer 29-30
16 Parameters 31
17. Limitations of the measuring system 32-34
18. Analyzer setup 35
3
3 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

4
What is what
Touch screen
Solution pack with waste pouch, reagents
and QC. The QC is built-in and automatic
for accuracy and full regulatory compliance.
Sensor cassette compartment behind the door
Self-cleaning inlet aspirates the sample in 5 seconds
Automatic sample mixing for safePICO syringes
(mixing takes 7 seconds)
Integrated barcode reader
Fully operational on battery and optional rolling
stand for added flexibility
Identify the main parts of the analyzer
Printer and handle
4 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

5
Syringe samples – preanalytical errors
Sample collection and handling
1. Stable respiratory condition
To get a true picture of the patient’s respiratory condition the
patient should ideally be in a steady state of ventilation:
• Patients should be at rest for 5 minutes before sampling
• Ventilatory settings should be unchanged for 20 minutes
before sampling
• Pain and anxiety can influence the state of respiration so this
should be minimized wherever possible
2. Appropriate patient and sample identification
• Prevent mix-up or loss of samples
• Avoid re-sampling of patients
• Prevent misdiagnosis and wrong treatment
• Facilitate cross-charging
• Avoid litigation and lost billing opportunities
3. Appropriate preheparinized sampler with dry
electrolyte-balanced heparin
• Heparin is the only anticoagulant recommended by
Radiometer
• Slows the clotting process
• If applicable, explain about the different types of heparin:
Dry/liquid/balanced/non-balanced
• Dry electrolyte-balanced heparin (Na+, K+, Ca2+) is preferred
Stress that mixing with anticoagulant should be done as soon
as possible after sampling – but first visually inspect the sample
for air bubbles, expel all air bubbles, then mix.
Training method
Take the trainee through the possible preanalytical errors and explain how "quality in" equals "quality
out": better sample quality will provide more accurate results.
Emphasize the importance of the following points and adjust your messaging according to local
procedures. Demonstrate the steps whenever it seems helpful.
5 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

6
Syringe samples – preanalytical errors, continued
Sample collection and handling
5. Visually inspect sampler and expel all air bubbles
• Air bubbles can affect O2and CO2values
safePICO syringes: Expel air bubbles through the vented safeTIPCAP
• Cap syringe to avoid contact with room air
6. Manual mixing or mixing using the integrated
mixing device
Stress that mixing makes the sample more homogeneous:
• Mixing reduces sedimentation
• Hemolysis may cause K+
↑, Na+↓and Ca2+↓
• When mixing manually, invert the syringe according to local guidelines
• Discuss how to mix a sedimented sample, follow local guidelines.
• There is no real consensus as to how to invert a syringe –
an easy way to mix manually is by rolling the syringe between
your palms
• Stress that the integrated sample mixer is for safePICO
syringes only


4. Correct volume of blood
• Too much blood = increased risk of clotting
• Too little blood = possible heparin binding effect
(may cause lower Ca2+ value)
• Flush solutions used in A-lines must be removed from the
sample site to avoid dilution of blood samples
• It is recommended to withdraw a volume equal to three to
six times the “dead space” of the catheter system (CLSI)
Be aware of possible mixtures of venous and arterial blood: If
a self-filling syringe does not fill quickly, it may be because the
needle punctured the back of the arterial wall and continued
into a vein (with a lower pressure). In that case, a new sample
should be taken.
7. Analyze quickly
• If not analyzed quickly, the sample will continue to metabolize, causing the following:
pO2↓since O2will still be consumed
pCO2↑since CO2will still be produced
pH ↓due to change in CO2
cCa2+ ↑ the change in pH will influence the binding of Ca2+ to protein
cGlu ↓since glucose will be metabolized
cLac ↑due to metabolism
6 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

7
Syringe samples – how to measure a patient sample
1. Operator identification
• Sharing barcodes
• Accountability and traceability
• Patient records are kept according to local rules (usually records
are kept for many years)
2. "Ready" mode
Point to the analyzer status field and explain how the analyzer
will display current activity. The analyzer can only measure
samples when the screen shows “Ready”.
Training method
First, demonstrate how a sample is measured in real-time speed before doing a slow step-by-step
demonstration. Let the trainee try the process – both with and without trainer guidance.
Emphasize how the analyzer provides feedback (sound and light indications) and provides on-screen
guidance throughout the process.
7 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

8
Syringe samples – how to measure a patient
sample, continued
3. Introducing the sample
Present the following steps on how to introduce the sample.
Then the trainee:
1. Should repeat the steps as a practical exercise.
2. Should be informed that the analyzer will guide with on-screen video, sound and
instructions during the process.
Key words:
LIFT – ALIGN – PUSH – HOLD – REMOVE – CLOSE
LIFT
• Lift the inlet to the "syringe" position until the
green light appears
ALIGN
• Align sampler with inlet gasket
• If available, select mode
PUSH
• Push the sampler onto the inlet, applying
pressure to depress the inlet gasket
HOLD
• Hold the sampler in place while the sample is
automatically aspirated
REMOVE
• Gently remove the sampler from the inlet
when prompted
CLOSE
• Close the inlet
No safe TIPCAP With
safe TIPCAP
8 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

9
4. Appropriate patient information
If applicable, explain how to recognize a mandatory field by the
pointing hand. A mandatory field needs an entry before the results
can be shown. Results will be recorded but will not be visible or
retrievable without advanced user access.
• Other patient information for calculations or of clinical value.
Follow local guidelines.
5. View results (on-screen, printout or local information
system)
Discuss actions according to local guidelines.
• Critical limits
• Error messages and symbols
• ? = Error
• Reference ranges
• Review printout
6. Documentation and reporting of results –
Patient results log
• Result retrieval
• Filtering results (if required)
• Trend facility (if required)
• Acid-base chart
7. About ranges and critical limits
Measurement results are marked by symbols to show where
they fall in relation to reference ranges, critical limits, and
reportable ranges. The diagram illustrates these relationships.
8. Log off the analyzer
• Demonstrate how to log off the analyzer, and discuss the
consequences of not logging off
1 Reference range 4 Reportable range
2 Lower critical limit 5 Range of indication
3 Upper critical limit
Syringe samples – how to measure a patient
sample, continued
9 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

10
Capillary tube samples – preanalytical errors
Sample collection and handling
1. Stable respiratory condition
To get a true picture of the patient’s respiratory condition, the
patient should ideally be in a steady state of ventilation:
• Patients should be at rest for 5 minutes before sampling
• Ventilatory settings should be unchanged for 20 minutes before sampling
• Pain and anxiety can influence the state of respiration so this should be minimized
wherever possible.
2. Appropriate patient and sample identification
• Prevent mix-up or loss of samples
• Avoid resampling of patients
• Prevent misdiagnosis and wrong treatment
• Facilitate cross-charging
• Avoid litigation and lost billing opportunities
3. Appropriate preheparinized 70 µLcapillary tubes
(
safe CLINITUBES, plastic) or 100 µL capillary tubes
(CLINITUBES, glass)
• Heparin is the only anticoagulant recommended by Radiometer
• Slows the clotting process
• If applicable, explain about the different types of heparin:
Dry/balanced/non-balanced. Dry electrolyte-balanced heparin
(Na+, K+, Ca2+) is preferable
• If using capillary tubes coated with high-concentration sodium
heparin, do not report electrolyte values
• Always gather everything you need before you start (70 µL
capillary tube, two end caps, magnetic wire, magnetic mixer and an
ABL90 FLEX clot catcher).
4. Correct volume of blood
• Completely fill the capillary tube with blood
• Minimum size capillary tube is 70 µL
• Do not “milk” the tissue to avoid contamination of the sample with tissue liquid
Training method
Take the trainee through the possible preanalytical errors and explain how "quality in"
equals "quality out": better sample quality will provide more accurate results.
Emphasize the importance of the following points and adjust your messaging according
to local procedures. Demonstrate the steps whenever it seems helpful.
10 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

11
Capillary tube samples – preanalytical errors, continued
Sample collection and handling
5. Sample should be free of air bubbles
• Air bubbles can affect O2and CO2values
• Ensure the end caps match the type of capillary tube
• Cap both ends of the sample to avoid contact with room air
6. Mixing
• Mix GENTLY with the mixing wire and magnet to avoid hemolysis
of the sample
• Hemolysis may cause K+
↑, Na+↓and Ca2+↓
• Mix 20 times along the full length of the capillary tube or mix
manually by inverting the capillary tube 20 times
7. Analyze quickly
• If not analyzed quickly, the sample will continue to metabolize, causing
the following:
pO2↓since O2will still be consumed
pCO2↑since CO2will still be produced
pH ↓due to change in CO2
cCa2+ ↑the change in pH will influence the binding of Ca2+ to protein
cGlu ↓since glucose will be metabolized
cLac ↑due to metabolism
If not analyzed <30 minutes, store plastic capillary tubes at room temperature. Glass capillary tubes
can be stored in ice slurry.
11 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

12
Capillary samples – how to measure
a patient sample
1. Operator identification
• Sharing barcodes
• Accountability and traceability
• Patient records are kept according to local rules (traditionally kept
for many years)
2. "Ready" mode
• The analyzer will always display current activity, e.g. QC
measurement
• Ready = Green light at the sample port
• Not Ready = Yellow (amber) light at the sample port
3. Remove end caps and attach the ABL90 FLEX Clot Catcher
• Hold the capillary tube by the clot catcher for better control
• Ensure that the clot catcher is placed at the opposite the end
compared to the mixing wire
Training method
First, demonstrate how a capillary sample is measured in real-time speed before doing a slow step-by-
step demonstration. Let the trainee try the process – both with and without trainer guidance.
Emphasize how the analyzer provides feedback (sound and light indications) and provides on-screen
guidance throughout the process.
12 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

13
4. Introducing the sample
Present the following steps on how to introduce the sample.
Then the trainee should repeat the steps as a practical exercise.
Inform the trainee that the analyzer will guide with on-screen video,
sound and instructions during the process.
Key words:
LIFT – PUSH – HOLD – REMOVE – CLOSE
LIFT
• Lift the inlet to the “Capillary” position until the green light appears.
PUSH
• Push the capillary tube onto the inlet, applying pressure to depress
the inlet gasket
HOLD
• Hold the capillary tube in place while the sample is automatically
aspirated
REMOVE
• Gently remove the capillary tube from the inlet when prompted
CLOSE
• Close the inlet
Capillary samples – how to measure
a patient sample, continued
13 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

14
5. Appropriate patient information
If applicable, explain how to recognize a mandatory field by the
pointing hand. A mandatory field needs an entry before the
results can be shown. Results will be recorded but will not be
visible or retrievable without advanced user access.
• Other patient information for calculations or clinical value.
Follow local guidelines.
6. View results (on-screen, printout or local information
system)
Discuss actions according to local guidelines
• Critical limits
• Error messages and symbols
• ? = Error
• Reference ranges
• Review printout
7. Documentation and reporting of results –
Patient results log
• Result retrieval
• Filtering results (if required)
• Trend facility (if required)
• Acid-base chart
8. About ranges and critical limits
Measurement results are marked by symbols to show where
they fall in relation to reference ranges, critical limits and
reportable ranges. The diagram illustrates these relationships.
9. Log off the analyzer
• Demonstrate how to log off the analyzer and discuss the
consequences of not logging off
Capillary samples – how to measure
a patient sample, continued
1 Reference range 4 Reportable range
2 Lower critical limit 5 Range of indication
3 Upper critical limit
14 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

15
Component consumables
1 Reference range 4 Reportable range
2 Lower critical limit 5 Range of indication
3 Upper critical limit
Smart chip containing various information, no further
scanning of product barcodes necessary
Contains pouches with QC and calibration material, a
gas mixture and closed containers to hold liquid waste
Security pin for activation of the solution pack
Training method
To enhance the trainee's understanding of how to change consumables, point out and explain the
following details on the consumables.
Reference sensor. Do not shake the sensor cassette!
There is no need to mix the solution in the reference sensor.
Smart chip containing various information, no further
scanning of product barcodes necessary
Board with sensors. Hemoglobin and bilirubin are measured
by the oximetry module built into the analyzer.
15 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

Changing consumables, continued
Changing the thermal printer paper
• Show how to enter Analyzer Status on the analyzer screen and find
> Consumables > Replace > Paper
• Show where to find and press the release button to open the cover and
remove the used paper roll
• Let the trainee place the new paper roll, tell or show that the paper
must unwind from below
• Let some paper extend out of the printer
• Close the cover and tell that the cover must “click” to be correctly in
place
• Point to the analyzer screen and complete the procedure
Training method
Demonstrate with participation of the trainee how to replace a consumable in a slow step-by-step
guidance. Emphasize how the analyzer provides feedback (sound and light indications) and provides
on-screen guidance throughout the process.
16
16 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

Changing consumables – solution pack
• Show how to enter Analyzer Status on the analyzer screen and find
> Consumables > Replace > Replace Solutions.
• Lift the inlet handle to the capillary position and wait until the solution
pack is released
• Let the trainee remove the solution pack and dispose of it as
biohazardous waste according to local guidelines
• Take a new solution pack and demonstrate how get it out of the box
without pulling or lifting in the pump tube
• Lift the new solution pack out of its box as shown and place it on an
even surface
• Now let the trainee try to get the solution pack out of the box
• Let the trainee pull the red pin out of the new solution pack
• Show how to place the palms of your hands over the edges of the
lid as shown
• Now let the trainee place their palms and tell them to press down
firmly and evenly with both hands until the tabs click into the two holes
• Stress that both taps must click into place for the solution pack to be
activated correctly
17
Changing consumables, continued
17 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

Changing consumables continued
Changing consumables – sensor cassette
Note: The analyzer has to condition a new sensor cassette after it is
installed. This process can take up to 4 hours.
• Show on the analyzer screen how to enter Analyzer Status
and find > Consumables > Replace > Replace sensor cassette
• Show how to start the video guidance and wait until the sensor
cassette compartment opens
• Let the trainee try to remove the sensor cassette and dispose of it
as biohazardous waste according to local guidelines
• Tell that actions have to be confirmed at the analyzer to advance
the video guidance, so press > Action Completed
Let the trainee do all of the following steps:
• Pull the foil off the new sensor cassette pack
• Unscrew the lid and lift out the sensor cassette
• Observe that the trainee tap > Action Completed before putting
the new sensor cassette in place
• Follow the on-screen guidance for completing the procedure
Note: If you tap the “Exit conditioning” button, the analyzer will not
perform the more frequent calibrations that normally follow in the 24
hours after a sensor cassette replacement. This may have a negative
effect on the accuracy and precision of patient results during this
time.
18
18 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

19
Troubleshooting
Explain how the trainee can see when the analyzer is ready for use:
The analyzer is ready for use when all three conditions are present.
1. The analyzer is in Ready mode.
2. The color of the tab of the parameters you want to get a result for is green or yellow.
3. The color of the traffic light in the Analyzer status button is green or yellow.
If applicable, explain about the following points:
Remaining test cycles:
• Sensor cassette icon –
the number adjacent to the icon shows
the number of tests that are left.
• Solution pack icon –
the number adjacent to the icon shows the
number of activities that are left.
Access to the data logs such as Patient Results Log
Analyzer status button – the color of the traffic
light on the button shows the overall status of
the analyzer. Press the button to access detailed
status information.
19 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019

General information
Training method
Take the trainee through the following general information, demonstrating the processes when it
seems necessary.
Cleaning the analyzer
• Remember to clean the inlet and the integrated mixing device according to local guidelines
Compliance
Infection control
• Always comply with hospital guidelines regarding collection, handling, and disposal of blood
• Password expiration – if applicable, discuss why it is necessary
On-going competency testing
• If applicable, discuss training and assessment
Who is your first point of contact?
• Laboratory/POC
……………………………………………….....................................................................................................
• Other
………………………………………………......................................................................................................
20
20 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019