FAN LactoFAN2 User manual

Instructions for Use
H2Breath Test Device
LactoFAN2
V. 1.16 –1.21

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The information contained in this manual may be changed by Fischer ANalysen
Instrumente GmbH without prior notice.
Utmost care was taken in the compilation of text and images. However, we cannot
absolutely exclude errors. Fischer ANalysen Instrumente GmbH cannot accept any legal
or other liabilities for incorrect data and the consequences arising thereof.
In case of doubt, the German version shall apply.
Copyright
Copyright 2010-2014 Fischer ANalysen Instrumente GmbH. All rights reserved.
Duplication, modification and translation not covered by copyright need prior consent of
Fischer ANalysen Instrumente GmbH.
Trademarks
All trademarks or registered trademarks are the property of their respective owners. All
rights reserved.
Credits
The firmware of this device was created using the IAR Systems’ Embedded Workbench®
software.
Edition
2015-09-07


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Table of contents
Intended use........................................................................................................................3
Basics..................................................................................................................................4
Limits of method ..................................................................................................................4
Literature..............................................................................................................................4
Unpacking, check for completeness ....................................................................................5
Environmental conditions.....................................................................................................6
Short description..................................................................................................................6
Commissioning....................................................................................................................7
Preparations for work...........................................................................................................8
Operation.............................................................................................................................8
PC connection ...................................................................................................................13
Functional tests..................................................................................................................13
Cleaning.............................................................................................................................13
Calibration..........................................................................................................................14
Maintenance......................................................................................................................16
Main battery.......................................................................................................................16
Sensor backup battery.......................................................................................................16
Sensor Expiry ....................................................................................................................16
Errors.................................................................................................................................17
Warnings............................................................................................................................19
Warnings and notes on safety ...........................................................................................19
Warranty............................................................................................................................19
Training..............................................................................................................................19
Symbols.............................................................................................................................20
Environment.......................................................................................................................20
Spare parts, consumables and service..............................................................................20
H2breath test protocols with LactoFAN2...........................................................................23
Specifications.....................................................................................................................24
Manufacturer declaration of electromagnetic compatibility of H2breath test device
“LactoFAN2”......................................................................................................................25
CE declaration...................................................................................................................28
Declaration of Quality.........................................................................................................29
Index..................................................................................................................................30
Important note
Do not expose this device to solvent or disinfectant agents!
This applies especially to alcohol in any way (liquids, vapors, aerosols).
Store this instrument in well aired rooms only, remove the adapter after every
measurement and allow the sensor to dehumidify.
In case the sensor got gas-blind by the influence of chemical substances, ventilate the
device 24 hours into fresh air.
Intended use

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The LactoFAN2is used in the malabsorption diagnosis of lactose or other sugars.
Additional the investigation of intestinal transit time and bacterial overgrowth of is possible.
Basics
In case of malabsorption, sugar (e.g. Lactose) undigested passes into the large intestine
where action by bacteria causes the release of hydrogen, which is absorbed through the
intestinal wall and dissolves into the blood stream.
The dissolved gas is released into the lungs through the capillary blood vessels
surrounding the alveoli and then expired.
An increased concentration of expired hydrogen following lactose ingestion therefore
reveals lactose malabsorption and can be easily and accurately measured by the
LactoFAN2.
This forms the basis of the lactose tolerance test whereby a subject ingests a measured
quantity of lactose, after an overnight fast, and has the concentration of expired hydrogen
measured. This is done prior to ingestion and at 30-minute intervals thereafter for three
hours in total. A rise of 20 ppm or more in expired hydrogen indicates lactose
malabsorption. If other symptoms such as abdominal pains are reported then lactose
intolerance may be diagnosed.
The LactoFAN is based on an electrochemical fuel cell which works through the reaction of
hydrogen with an electrolyte at one electrode and oxygen (from ambient air) at the other.
This reaction generates an electrical current proportional to H2concentration. Output from
the fuel cell is sensed by a microprocessor, which detects peak concentrations of expired
gas and displays the result in parts per million (ppm) on an OLED display.
Limits of method
Established diagnosis out of the readings of the H2monitor only is not possible. This will
reserved to the doctor’s valuation.
As described in detail by the literature addressing this topic, several influences as
symptoms appearing during the test, adhering to the time of fastening before the test,
possible interferences by other diseases, H2non-production, intolerances and other more
have to be taken into account.
Furthermore the properties of an electrochemical sensor regarding resolution and
reproducibility of the output signal are to be observed during evaluation.
This applies too in case of automatic generation of an external finding by the FANh2
software.
Literature
M. Ledochowski
H2–Atemteste
Verlag Ledochowski, Innsbruck 2008
Levitt MD,
Production and excretion of Hydrogen gas in man
New England Journal of Medicine 1969; 281, 122–127.

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Unpacking, check for completeness
Take all parts contained out of the transport box and check the consignment regarding
completeness. In case of transit damages immediately inform the sender. Do not use
damaged parts.
The LactoFAN2is shipped in a carry case, containing the items below:
LactoFAN2(Order No. LF2)
nose clip (Order No. HZ–NK)
4 pcs. AA size batteries
1 pcs. one-way Filter Mouthpiece (yellow plastic, Order No. LF2-AC-01-xxx)
1 pcs. mouthpiece adapter with one way valve (translucent plastic, Order No. HZ-ADV)*
1 pcs. one-way cardboard Mouthpiece (Order No. HV-MU150)*
Additional included in delivery:
mini USB cord
software CD
quick start manual
this full manual
Optionally available are:
calibration gas 100ppm H2(Order No. HV–Lacto–CG)
calibration set (Order No. HZ–CV + HZ–RedC)
FANh2 software usable for evaluating and managing breath tests, automatically report
generation and printing as well as able to connect to practice–or hospital–information
systems (Order No. H–soft)
gas sampling system (Order No. HZ–GAMU)
disinfectant/sterilant PeraSafe™ (HC–Des–Pera)

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Environmental conditions
To avoid “Gas blindness” of the sensor and to achieve reliable results when working with
your H2breath test device, please do not store the device in the neighborhood of places
where you:
disinfect surfaces
use cleaning sprays (applies to pump sprays, e.g. for ECG electrodes cleansing, too)
use disinfectant or sterilization agents (e.g. Alcohol)
A short-time use of the device in polluted function rooms for the purpose of performing a
single measurement is feasible, but after that the device have to be stored in a well-aired
room again. Do not touch the device with hands just disinfected.
1. display with touch screen
2. flange with mouthpiece detection
3. H2sensor
4. battery cover
5. battery compartment
6. battery cover lock
7. mini USB socket
8. on/off switch
Short description
The H2breath test device LactoFAN2is designed as handheld device powered by
batteries or accumulators. You can switch it on/off with (8).
Operation, user guide and measuring data output is done via (1) completely. For sampling,
a special mouthpiece (see page 5) is inserted in (2) and breath blown onto (3). The
mouthpiece has to be removed after every measurement.
1
2
3
4
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5
6
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7
8

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Commissioning
To get precise results the instrument shall be operated at room temperature only. Was it
exposed to heat or cold before use, you have to wait a sufficient time to let the device
reach room temperature.
Insert the batteries according to the marks inside the battery compartment. For this, open
the battery cover by pressing its lock and lift it simultaneously. Do not forget to close and
to secure the cover again.
Switch on the device by pressing the top right knob shortly.
After the splash screen the main screen shall be displayed (see left):
1. main battery charge indicator (shown: low –change main battery soon)
2. sensor back-up battery charge indicator (shown: low –device service needed)
3. remaining days until next calibration (press to start calibration)
4. start measurement
5. change settings
6. view saved measurement data
7. measurement values dimension
8. H2instantaneous value
9. H2measurement value (= maximum)
Press the “change settings” button and after it the clock button to check date and time. If
you need to change some value, touch it. Then you can adjust it using the up and down
buttons. Pressing the green OK button you’ll take over the settings and leave the screen.
If the screen “set clock” is displayed from the start, proceed accordingly.
The device will switch off after some minutes of inactivity if you didn’t turned it off before by
long-pressing the on/off knob.
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2
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3

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Preparations for work
Before a breath test, please inform yourself in time about the substrates needed and how
to act in case of emergency arising from intolerances.
Make sure, the subject kept the fasting period specified for the breath test regarding.
To measure breath samples you need:
the nose clip
a one-way filter mouthpiece
the H2monitor LactoFAN2
a protocol suitable for the test performed to record the H2concentration in breath
chronologically, created by your responsible doctor
(example protocols you can find at the software CD delivered or in the FANh2 software)
the substrate specific for the test to be performed
When you are going to perform a breath test, please switch on the device to ensure its
readiness for operation.
If there are any warnings displayed (e.g. battery low), please follow the instructions in
the regarding chapter of this manual.
Check whether the device is in a calibrated state (see page 7). If not, perform a
calibration (see page 14).
Operation
The H2monitor is provided with varied configuration options to adapt its functions to the
requirements of your daily work. The descriptions following, however, refer to the default
delivery state.
In case questions arise concerning to extended configuration settings or to display
screens, please refer to the list of all graphics delivered on CD.
Remark:
You may demonstrate the whole measurement cycle to the subject. In this case, after
the sampling press the cancel button to drop the value displayed.
If the subject is unable to comply with the above procedure, especially with regard to
expiration time, then the expired gas may be collected into a bag and expelled over the
sensor using a gas sampling system (see page 5).

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Explain to the subject the right usage of the mouthpiece:
Correct:
The mouthpiece fits closely to the subject’s lips; no breath escapes.
Wrong:
The rim indents the subject’s lips; the respiratory air may escape sideways.

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Now switch on the device as described above. The display now shows a step-by-step
graphic guide:
Main screen
Press the right button to start a measurement.
First start:
Press the center button to switch to the settings screen and check the time and date settings.
In case a red exclamation mark is shown at the calibration gas bottle in the upper right corner,
touch the icon to start the calibration of the device. Follow the graphic guide on the screen.
Please read the regarding chapter of this manual before (see page 14).
Patient selection
Press one of the six buttons to set the table into which the measurement
data of the current patient will be stored.
This button will abort the measurement always.
Data table
Verify to have selected the right (patient-) table, then press the OK-
button.
For the first measurement the table will be empty; later here you will see the data already collected.
If you want to start a new table, press the center button.
Make sure the data were saved before (see page 13).
Plug on the mouthpiece
Push the filter mouthpiece firmly into the flange.
Was the mouthpiece detection disabled in the settings, the OK-button is shown.
Press it when finished.
Take breath
Breath normally (do not inhale more deep than usual) and stop after
inhaling.
The patient should sit down during the whole procedure; also ask the subject to use the nose clip delivered.