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


Manual LactoFAN23 of 30
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
4
5
6
6
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.
5
6
4
9
7
8
2
1
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.

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Hold breath
While the countdown, hold the breath.
If the patient is able no more to hold the breath before the countdown is over, press the OK-button to
continue.
Blow into the device
Put the mouthpiece to the lips tightly and exhale slowly and as long as
possible (20 s).
The system got a big flow resistance and supports the subject in achieving a long expiration time.
It is important that the patient exhales completely, because the relevant part of breath for determining the H2
concentration comes from the tip of the lung.
Press the OK-button to continue.
Wait for maximum reading
There may be a delay of some seconds before any reading appears. Do
not turn off the unit during this time.
Because of there is a certain delay in the chemical sensor’s output, the reading is monitored for further
increasing.
After a decay of 2ppm but not later than after 30 seconds the device switches to the next screen.
Confirm measurement
Press the OK button to store the reading.
If you press the cancel button this measurement is discarded. You can try again after the recovery time is
over.
Take out the mouthpiece
Pull the filter mouthpiece out of the device. Instruct the subject to keep
the mouthpiece for the following measurements of the breath test.
Was the mouthpiece detection disabled in the settings, the OK-button is shown.
Press it when finished.

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Take in the substrate
Press the OK-button when the patient has taken the substrate for the H2
breath test.
After the first measurements of a breath test (= basal sample) the subject has to take in the substrate.
According to your working instructions, prepare the particular test substance already before the start of the
breath test.
All times listed in the protocol are related to the administration time. Therefore, press the OK-button not
before the substrate was taken.
Set timer
Using the up- and down-buttons set the ringing time. Press OK to
confirm.
Afterwards, the device switches back to the main screen. If you do not intend to examine another patient, you
may switch off the device.
Setting the timer take into account not only the next measurement time according to your breath test protocol
but the time needed to call the patient too.
Press the cancel button if you finished the measurements for the current patient. The device will
not ring for this patient again. Timers for other patients are not affected.
Recovery time runs
Wait until the sensor is ready for the next measurement.
During the recovery time must be no mouthpiece or adapter plugged on.
Wake-up screen
The next measurement for the patient number shown is waiting.
Press OK to start the measurement procedure.
In the settings, you can enable or disable the wake-up function.
Before a new measurement the mouthpiece has to be removed for at least
2 minutes.
This is necessary to allow the sensor surface to dry and to enable a zero point
adjustment using ambient air. Previously the next use you have to convince
yourself of all condensed humidity has vaporized off the sensor surface.

Manual LactoFAN213 of 30
PC connection
The LactoFAN2can be connected to a USB port of a PC
to transfer measurement data of completed breath tests to
the computer.
First, install the LactoFAN2Windows software from the CD
delivered.
Do not connect the device to the PC prior to software
setup, because in this case the installation of drivers
necessary for communication may fail.
If you encounter problems, please ask the FAN service for
help (see page 20).
After software setup, connect the device to the PC. Follow
the driver installation process of your Windows system.
When finished, the display will show the USB connection
symbol at the right.
After this you can start the software to transfer data from your breath test device to the PC.
There are some different file formats available. So you can save, print and process your
data easily.
Functional tests
In daily operation it is not necessary to submit the LactoFAN2any functional tests. This
does not affect the requirements for calibration and maintenance.
If you suspect results to be incorrect, (e.g. if you get zero readings despite of
malabsorption symptoms incidence during the breath test), please ask the FAN service for
help (see page 20).
The device monitors all important parameter automatically:
base line drift
sensor recovery time
calibration range and period
temperature
main and backup battery charge
Cleaning
The surfaces of the instrument, excepting the sensor surface, may be wiped using a clean
cloth damped with a mild detergent solution.
If the application of a disinfectant is advisable, FAN recommends the use of PeraSafe™
sterilant (see page 5).
The sensor surface must not be wiped with any aqueous solutions and must
not be exposed to any solvents, e.g. alcohol, or permanent damage may
result.

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Calibration
FAN delivers the LactoFAN2already calibrated.
To achieve measurements of the greatest accuracy we recommend the unit be calibrated
after always one month.
FAN can supply calibration gas (100 ppm H2in Nitrogen) complete with a control valve for
simple and economic user calibration (see page 22).
The gas is supplied in convenient, disposable, aluminum aerosol cans containing 10 liters
of gas.
With this approximately 14 calibrations of the instrument can be readily achieved.
Please proceed as following:
Press the settings button (see page 7), to display the settings screen.
Press the button “start calibration”.
The screen will guide you through all steps necessary.
Screw the control valve firmly onto the cylinder and assemble the gas supply as shown
on the next page.
When requested, turn the control knob anti-clockwise until the ball in the flow indicator is
between the two marks. This will then supply a gas flow of approximately 0.3 l/min.
Now slowly turn the Apply this flow for 50 seconds and then turn off the supply. Do not
remove the reducing connector.
Wait until the reading has stabilized and then confirm the reading with the OK button.
The device adjusts the amplification in relation to the reference gas value set.
If you use calibration gas with a concentration different to the default (100 ppm H2), you
have to change this reference value according to the concentration indicated on the gas
cylinder label.
In order to stop any gas leak from the can after calibration, ensure that the control knob
is tightened firmly.
Only certified calibration gas from a reputable source should be used.
Ensure that no H2is present on the sensor before starting the calibration
procedure.
Ensure that the instrument and gas cylinder have stabilized at room
temperature before calibrating.
Do not immerse the unit in the calibration gas.

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100 ppm
hydrogen
in nitrogen
Flow
indicator
Control
valve
Reducing connector
for calibration
Plastic tubing

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Maintenance
FAN recommends an annual inspection of the device.
During this inspection performed by the FAN service –as well as after any repair –the
device is revised regarding proper functioning, adherence to specifications and technical
limit guidelines, stability and operational safety. Besides this, worn parts are replaced as
necessary.
In case such inspection is omitted the output values are still valid either, but there may
arise measurement difficulties or hardware failures after an indefinite time.
Main battery
The main battery is built up by 4 AA size batteries or accumulators. Its charge level is
indicated in the top left corner of the display.
If the battery is run down a warning is shown when the device is switched on or you are
going to start a measurement. The batteries have to be exchanged then.
For day-to-day use FAN recommends to get two sets of accumulators with an electronic
accumulator charger to ensure the constant availability of the device.
Please take the batteries out of the device in case you intend not to use it for a
longer period of time.
You have to set the internal clock when the device is returned to operation.
Sensor backup battery
The LactoFAN2is equipped with a 2-years life backup battery that keeps the sensor
prepared for instant response without any warm-up delay.
If the battery is run-down, the alert icon “backup battery low” is displayed (see page 7).
When this symbol is displayed, the H2meter must be returned for battery
replacement immediately to FAN GmbH, or an authorized agent. An
exhausted or removed battery may cause damages to the sensor.
Sensor Expiry
Sensor life ranges from 2 to 5 years and depends upon both the amount of exposure to H2
and other gases, particularly solvents such as alcohol and cleaning fluids. When the
sensor has expired it will become impossible calibrating the meter successfully.
When this occurs, the H2 meter must be returned to FAN GmbH, or an authorized agent,
for sensor replacement.
If during calibration (see page14) an error occurs (see page 17), the H2 meter
must be returned to FAN GmbH, or an authorized agent, for sensor
replacement.

Manual LactoFAN217 of 30
Errors
A) auto-zero error before
measurement
001 –zero point too low
Pollutants dissolved in the electrolyte of the sensor on
the counter-electrode generate a current opposing to
the measuring signal.
Cause: Long-tern contamination of the sensor by
pollutants (alcohol, disinfectants) from the ambient air.
002 –zero point too high
Pollutants in the ambient air generate a signal at the
measuring electrode of the sensor.
Cause: Acute exposure of the sensor to H2(e.g.
calibration gas) or pollutants from the ambient air.
128 –zero point instable
The signal of the sensor is not stable.
Cause: Same as for 002.
B) calibration error
004 –ADC resolution too low
The sensors' sensitivity is too low; it's not possible to
resolute the measurement signal sufficiently detailed.
Cause: Same as for 001 or working life of sensor is
over.
008 –overflow
The sensor's sensitivity is too high; the measurement
range of 300 ppm H2is not possible to be acquired.
Cause: Same as for 001.
016 –calibration range exceeded
The sensors' sensitivity alteration in respect to the last
calibration is out of the tolerance range.
Cause: Same as for 001 and 002 respectively or
working life of sensor is over.
Turn the unit off, remove the
mouthpiece or adapter, and
expose the sensor to ambient air
for 3 minutes.
If this warning appears again
then this indicates a possible
contamination of the sensor with
a solvent. In this case remove all
sources of solvents from the
vicinity of the sensor and expose
to ambient air for 24 hours before
switching on again.
If you got no success, send the
device to the FAN service
workshop (see page 20).
operator is going to pass over an
auto-zero error
FAN does not recommend
performing measurements in
case of zero point error.
The operator takes the
responsibility for highly incorrect
results if measurements are
continued.
Results will be marked with a "!".
ppm reading
stays 0 always
sensor contaminated
See top of page.
main battery run down
Replace the 4 AA size batteries.

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sensor backup battery exhausted
256 –sensor battery empty
Send the device to the FAN
service workshop (see page 20).
device temperature too high or low
032 –temperature too low
064 –temperature too high
Wait a sufficient time to let the
device reach room temperature.

Manual LactoFAN219 of 30
Warnings
sensor backup battery
low
Send the device to the FAN service workshop (see
page 20).
calibration has expired
Perform a calibration with calibration gas (see page
14).
Warnings and notes on safety
Please use the one-way filter mouthpiece with integrated bacteria and virus filter
intended to protect the device from being contaminated by infected persons.
Due to the sensor of the device is not disinfectable, otherwise there is the risk of
infection for other subjects.
Use every mouthpiece for one subject only.
Do not touch the inside of the mouthpiece flange, especially the surface of the sensor.
Do not exceed the maximum values for substrate dosage recommended in the literature
regarding and inform yourself how to act in case of emergency arising from
intolerances.
Adhere to the regulations, relevant in your country, concerning dealing with and
disposal of the batteries you use to run the device.
Keep the device out of reach of the patient while it is connected to a PC.
The LactoFAN should only be connected to a computer that is manufactured in
accordance with EN60950 –‘Safety of Information Technology Equipment including
Electrical Business Equipment’.
The FAN GmbH considers itself as responsible for basic safety, reliability and
performance of the LactoFAN2only in case the device is used in accordance with the
manual.
Only qualified personnel shall avail of the device.
Do not perform any maintenance procedures while using on the patient.
To open and repair the device is allowed for FAN or suitably trained persons only.
Warranty
The standard sales and delivery terms of Fischer ANalysen Instrumente GmbH apply.
The claim to guarantee is expelled, if repairs or changes in the device were carried out.
Training
You can receive hard–and software training (subject to a charge) by Fischer ANalysen
Instrumente GmbH (see page 20).

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Symbols

0197
CE conformity according to directive 93/42/EEC

manufacturer

adhere to the manual

do not put this device to your own dustbin; send it back to the manufacturer for
disposal
SN
serial number (contains date of production –placed inside the battery
compartment)
Environment
This instrument complies with directive EN60601-1-2 electromagnetic compatibility but can
be affected in the range from 470 MHz to 800 MHz by cellular phones and by
electromagnetic interferences (see declaration of conformity).
Spare parts, consumables and service
Orders for spare parts and consumables or general requests please send to the
manufacturer:
Fischer ANalysen Instrumente GmbH
Brahestraße 25–27
04347 Leipzig
Phone [phone]
Fax [phone]
E–Mail fan@fan–gmbh.de
Web www.fan–gmbh.de
Contact addresses for hard–and software support:
Phone [phone]
E–Mail service@fan–gmbh.de
Suggestions and proposals for improving this manual in hand or for correction of mistakes
are gladly welcome.