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13
C Breath Test Device
HeliFANplus FANci2–var
Quick Reference
Disclaimer
The information contained in this paper may be changed by Fischer ANalysen Instrumente
GmbH ("FAN") without prior notice.
Utmost care was taken in the compilation of text and images. However, we cannot
absolutely exclude errors. FAN cannot accept any legal or other liabilities for incorrect data
and the consequences arising thereof.
Copyright
©Copyright 2012–2017 Fischer ANalysen Instrumente GmbH. All rights reserved.
Duplication, modification and translation not covered by copyright need prior consent of
Fischer ANalysen Instrumente GmbH.
Trademark
Microsoft, Windows and other Microsoft product names mentioned in this manual are
trademarks or registered trademarks of Microsoft Corporation. All rights reserved.
Edition 2017‐05‐16
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Table of Contents
Disclaimer ................................................................................................................................. 2
Copyright .................................................................................................................................. 2
Trademark ................................................................................................................................ 2
Preface ..................................................................................................................................... 4
Main parts to know .............................................................................................................. 4
Mains switch ..................................................................................................................... 4
CO2 – Absorber ................................................................................................................. 4
Bag connectors ................................................................................................................. 4
FANci software ................................................................................................................. 4
How to blow a breath bag ........................................................................................................ 5
Preparing the analyzer to run breath tests ............................................................................... 6
Daily use ............................................................................................................................... 6
Notes on work with Daily Tasks Wizard ............................................................................ 7
Failures during run of Daily Tasks Wizard ......................................................................... 7
Daily Tasks Wizard Setup ...................................................................................................... 8
Set up the 13C analyzer after transport or being switched OFF ............................................. 9
Quality management .............................................................................................................. 10
Maintenance ...................................................................................................................... 10
Gas dryer ........................................................................................................................ 10
Dust filter ........................................................................................................................ 10
Case ................................................................................................................................ 10
Verify the analyzer .............................................................................................................. 10
Documentation ................................................................................................................... 11
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C breath test device quick reference page 3 of 11
Preface
This quick reference is intended to support the operator in the daily use of the 13C breath
test analyzers HeliFANplus (FANci3) or FANci2–var with the 13C breath test software FANci
version 2.20 or higher.
This paper does not cover the basics, the specifications and the installation of the device.
Also for warnings and precautions as well as for advanced software use or the use of the
automatic sample feeder (FANas) please refer to the full manuals.
Mains switch
It is to switch the device ON and OFF. After switching ON the device you have to wait 3
minutes before starting the PC software.
The switch is located at the rear and equipped with two fuses 1A / 250V slow blow.
Due to the analyzer has to be temperature stabilized it stays switched ON overnight or at
weekend. Switch it OFF for longer periods of inactivity.
CO2 – Absorber
The U–shaped is made of glass – handle with care! The absorber tube is located at the rear
and covert by a guard (HeliFANplus) or behind the front panel (FANci2–var) respective.
The aim is to generate CO2–free air ("zerogas") used to purge the device, to dilute breath
samples and to adjust the baseline of the analyzer.
If the absorber tube is exhausted (in the FANci software, the indicator under the device's
picture shows 100% blue), it has to be exchanged. Always use the appropriate software
function (in the FANci software, open menu item Analyzer/Routine tasks… and start
Exchange of absorber) to do so.
Do not fill the absorber by yourself. Ask your local dealer for regeneration of your old
absorber tube.
Bag connectors
The bag connectors ("Ports") at the front are to plug on the breath test bags to be analyzed.
The ports are fitted with switches to monitor the connectors. The software can read these
switches and will light the port lamp when the bag attached is recognized.
FANci software
To operate the analyzer, the Windows™ software "FANci" is used. The software controls the
analyzer via the USB bus and watches all important parameter and system functions.
The software optionally can be connected to a hospital information system.
If you got questions when using the software, view the software help by pressing the F1 key.
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How to blow a breath bag
The most important thing for 13C breath tests is to take the breath samples in the right way!
Disdain this you will experience failures leading to have to repeat the breath test procedure.
The subject shall blow every sample in the same way. If in doubt, repeat the sampling.
use always a new breath bag and a plastic straw
smooth down the bag, insert the plastic straw deeply (bevel cut inside)
hold the bag at the welded tube with one hand; hold the straw with the other one
sit down, breath normally (not deeply)
when inhaled, hold breath (as long as possible; at least 10 seconds)
blow all breath completely through the straw, slowly pull it out when reaching the
end of breath (still blowing)
attach the bag at the device or plug it
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Preparing the analyzer to run breath tests
Daily use
Start FANci – the software establishes the connection to analyzer and when ready
the Daily Tasks Wizard appears on screen with the Welcome page
o When a routine task is planned for today the wizard displays an appropriate
task button (e.g. System test),
o Start the task by clicking this button
o When the task is finished, an appropriate message is displayed and after
confirmation the Daily Tasks Wizard is back on screen
Click on Next button to switch to page Preparing Analyzer for Measurements
o When a linearization or validation of linearization is requested, fill a bag with
your breath and put it at the specified port
o Check Print linearization data on completion if desired
Click on Next button to switch to page QC test if planned for today
o enter the target DOB value of your control samples
Click on Next button to switch to page Tests to measure
o Click on Add breath test button to add breath tests to the list of tasks
o In the input mask Breath Test Data enter the data of patient and test and
press ENTER for taking over, repeat the last steps for the next breath tests
o When ready press ESC to leave the input mask (refer to the notes on test
creation in next paragraph)
o Check the data, click on Edit or Delete to edit or delete the selected test
Click on Next button to switch to page Summary
o The wizard displays the list of tasks to do – arranged in charges – with the
ports and the time period probably needed for carrying out the tasks up to
this
o Check Print out findings for each patient and/or Print out the list of test
results if desired
Click on Start button to start the run of tasks
o The wizard checks if the ports are occupied with a bag and displays a
corresponding message if not
o Put the bags at the ports as required
o If all ports are occupied with a bag the wizard disappears and starts to run the
tasks of first charge
When ready with a charge the Daily Tasks Wizard comes back on screen
o When there are more tests to measure, you will be asked to remove the
processed bags and to install the bags for next measurements that are
displayed in the list. When all bags are attached to the specified ports the
wizard disappears and starts to run the next charge
o When no more tests are to measure, the wizard displays the page
Tasks finished showing the list of all tasks processed.
Click on Close button to leave the wizard.
To start a new run of wizard choose the menu item Analyzer/Daily Tasks Wizard…
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Notes on work with Daily Tasks Wizard
Tests already contained in Current List (e.g. by a request from HIS) can be included in
a run of the Daily Tasks Wizard by activating the option Include tests already
contained in Current List on page Tests to measure.
Tests that are created after the run of tasks has been started are included in the list
of tasks automatically by the wizard. You can exploit this feature to create tests while
tasks (e.g. a linearization) are run in background. The wizard assist you in doing so by
providing the button The first charge is complete – click here to start in case the first
charge is complete (all available ports are occupied):
o After click on this button the wizard switches to page Summary and you can
start the run of first charge as described above.
o Then the wizard switches back to page Tests to measure and you can
continue to create tests.
If you want to add tests after the wizard is already closed but tasks are still
processed, you can do so by calling the Daily Tasks Wizard again with the command
Analyzer/Daily Tasks Wizard…
In this context, the wizard shows the page Tests to measure.
Also, tests created without using the wizard are added to the list of tasks as long as
there are tasks in process.
When working with auto sampler the Daily Tasks Wizard shows the input dialog for
charging a batch instead of the page Tests to measure. When ready with charging
the batch press ESC that brings you back to the wizard, displaying the tests inserted
in the batch. On page Summery the wizard includes the sampler batch as a whole as
one task.
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Daily Tasks Wizard Setup
The Daily Tasks Wizard reminds the user on carrying out
the gas dryer test – every 12 weeks
the system test – every 4 weeks
the exchange of absorber – if exhausted (accessed 1000 times)
the linearization – once a week
the calibration or validation of linearization – at start of the day
the quality control (QC test)
In addition, commonly used settings are implemented for
creation of breath tests (fields of input mask)
measuring breath tests (fast measuring mode, error treatment)
documentation of results (report format, default printer)
archiving results (archiving at end of program)
To carry out the default setup, perform the following steps:
Choose the menu item Options/Setup Wizard.
In Setup Wizard click the button Default Settings and follow the instructions given on
the next pages that may be different depending on pre–settings made before.
On page Start Options the options Establish communication with analyzer and Start
the wizard for carrying out daily tasks(…) should be checked.
Click on button Setup conditions for carrying out routine tasks.
In Routine Tasks click the button Default1 top right
Click on OK button
Back in Setup Wizard click on button Next and OK
These settings cause the program to start the communication with analyzer at start of
program and when established to start the Daily Tasks Wizard.
If you want to change the settings call the Setup Wizard again and navigate to the
corresponding page by pressing Next.
In the Program Settings, accessible with command Options/Program Settings... you may
make further adjustments.
1)
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Set up the 13C analyzer after it has been moved
Start device and software
o connect the device to the mains and switch it on
o connect the device with the computer using the USB cable
o wait some minutes
o start FANci software
o if not already done, start communication with analyzer by choosing the menu
item Analyzer/Communication.
o if the Daily Tasks Wizard is displayed cancel it
Carry out a system test
o choose the menu item Analyzer/Routine Tasks.
o in dialog Routine Tasks under System test click on Start now ..
o in System test click the Default1 button top right
o IMPORTANT! uncheck Adjust offset and amplification before
o press OK button to start the system test. Since the working temperature is
not reached at this time this check provides a preliminary but usable
evaluation of function of system components.
Let the device warm–up for at least 4 hours
Carry out a calibration and a system test:
o choose the menu item Analyzer/Routine Tasks.
o in dialog Routine Tasks under System test click on Start now ..
o in System test click the Default1 button top right
o press OK button to start the calibration and system test
Perform a linearization
o choose the menu item Analyzer/Routine Tasks.
o in dialog Routine Tasks under Linearization click on Start now ..
o in Linearization click the Default1 button top right
o uncheck Adjust offset and amplification before
o fill a bag with your breath and put it at the port specified for linearization
o press OK button to start the linearization of analyzer
o After completion, you get a corresponding message with the results of
linearization.
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Quality management
Maintenance
There two parts inside the device subject to annual maintenance. Maintenance shall be
performed by qualified staff only.
We recommends to send the analyzer once a year for inspection to FAN.
Gas dryer
Applies to HeliFANplus and FANci2–var single beam devices only.
The NAFION tube is to be exchanged after one year or when the NAFION drift check result is
out of the limits.
Part no.: F301‐GW‐07k
Dust filter
The dust filter insert is to be exchanged after one year.
Part no.: F306‐GW‐03k
Case
Use a lightly dampened warm cloth to clean the analyzer housing. You may use some
dishwashing liquid but no solvents.
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Documentation
All relevant information on analyzer system is archived in the system folder of breath test
device and may be called–up at any time. The comprehensive information on state of
analyzer system includes evaluation on basis of assessment criteria that may be used for
documenting the quality of analyzer over time.
To open the archive of the breath test analyzer
Choose the menu item Analyzer/Reports/Archive…
In the Report Archive select one of the items in Type list
o Linearization – parameters of linearization
o System – status of system components
o QC test – results of quality control test
o Gas dryer test – results of gas dryer test
o Stability – stability of detector signals
o Temperature – temperature control parameters
o Calibration – history of calibration data
To display the available data arranged in the list with the newest on top select an
item and click on Preview or Print to preview/print the data (not available for
calibration data).
Click on Print last of each to print the report of each data type (except calibration
data) together with a Summary Report that lists the results, the evaluation and
evaluation criteria for each data.
Click on Print Summary Report to print out the Summary Report only.
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