Bedfont GastroCH4ECK Gastrolyzer User manual

Helping to detect gastrointesnal disorders, one breath at a me.
USER MANUAL
GastroCH4ECK Gastrolyzer®®

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Important Information/Reminders
WARNING: Please read the manual before use.
WARNING: Breath tests must only be carried out with Bedfont® accessories. Failure to do so may
cause incorrect readings.
WARNING: The mouthpieces are single patient use only. Further re-use could cause incorrect
readings and could increase the risk of cross infection which may result in decreased accuracy of
results. The mouthpiece should be disposed of after use, in accordance with local waste disposal
guidance.
WARNING: Do not open the GastroCH4ECK® Gastrolyzer®, this could result in bodily harm.
WARNING:Never use alcohol, substances containing alcohol, or other organic solvents as these
vapours will damage the sensors.
WARNING: Under no circumstances should the instrument be immersed or splashed with liquid.
WARNING: To reduce the risk of electrical shock, this equipment uses a three-wire electrical cord
and plug to connect the GastroCH4ECK® Gastrolyzer® to earth-ground.
WARNING: Fuses protect certain electrical circuits within the GastroCH4ECK® Gastrolyzer® against
overcurrent conditions.
WARNING: For continued protection against the risk of fire, replace only with the same type and
rating specified.
WARNING: Only fuses with the following ratings should be applied: 250Vac, 3.15AH T, 1500A
breaking capacity.
WARNING: The GastroCH4ECK® Gastrolyzer® is not designed for use with materials capable of
developing flammable or explosive vapours.
WARNING: If the GastroCH4ECK® Gastrolyzer® is used in a manner other than that specified in this
manual, the safety and performance of this equipment could be impaired. Further, the use of any
equipment other than that recommended by Bedfont® has not been evaluated for safety. Use of any
equipment not specifically recommended in this manual is the sole responsibility of the user.
WARNING: When selecting an accessory for the GastroCH₄ECK® Gastrolyzer® monitor, please be
advised that an accessory not recommended by Bedfont® may result in loss of performance and may
compromise the safety of the device.
CAUTION: Do not use hand sanitising products containing alcohol as this may damage the sensors.
CAUTION: The GastroCH4ECK® should not be operated in an environment outside of the
temperature or humidity ranges stated in the technical specification.
CAUTION: The GastroCH4ECK® should be switched off once every 24 hours.

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CAUTION: Portable and mobile RF communications equipment can affect the GastroCH4ECK®
Gastrolyzer®.
CAUTION: Sensor use beyond the specified component lifetime without servicing may compromise
result accuracy.
CAUTION: Use only accessories designed for use with the GastroCH4ECK® Gastrolyzer®.
CAUTION: Please do not attempt to modify the equipment in any way or use accessories not
specified by the manufacturer. Any attempt to do so, will invalidate the warranty and may cause
product failure or damage to your GastroCH₄ECK® Gastrolyzer® monitor. The product warranty does
not cover product failure or damage resulting from use with non-approved accessories.
NOTE: The instrument should be calibrated prior to first use, after transportation, and every 4
weeks.
NOTE: Please allow the GastroCH4ECK® to be switched on for at least 5 minutes prior to calibration.
NOTE: The GastroCH4ECK® device temperature needs to be at 21°C ± 4°C (69.8°F ± 39.2°F) to be able
to perform a calibration.
NOTE: Bedfont® recommends an annual service in order to check sensor and component parts
performance.
NOTE: Servicing should only be carried out by a Bedfont® trained representative
NOTE: Bedfont® will make available on request service training to appropriately qualified personnel.
NOTE: Please refer to Bedfont’s infection control and maintenance guidelines for further
information on infection control.

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Contents
Important Information/Reminders.........................................................................................................1
Definitions...............................................................................................................................................4
Introduction ............................................................................................................................................ 4
Intended Use........................................................................................................................................... 4
Contraindications....................................................................................................................................5
Compliance .............................................................................................................................................5
Instrument Layout................................................................................................................................... 5
Parts and accessories.............................................................................................................................. 6
Installation and Set-up............................................................................................................................ 7
User Interface ......................................................................................................................................... 8
Breath Testing......................................................................................................................................... 9
Analysing a Breath Bag Test..................................................................................................................11
Maintenance .........................................................................................................................................13
Calibration............................................................................................................................................. 14
Technical Specification.......................................................................................................................... 18
Using the GastroCH4ECK® Gastrolyzer® with GastroCHART™ ..............................................................19
Buttons.................................................................................................................................................. 19
Troubleshooting....................................................................................................................................20
Glossary of Symbols and Safety Information........................................................................................24
Warranty ...............................................................................................................................................31
Returns..................................................................................................................................................31
Responsible Manufacturer and Contacts..............................................................................................31

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Definitions
WARNING: indicates a potentially hazardous situation, which, if not avoided, may result in minor or
moderate injury.
CAUTION: indicates a potentially hazardous situation, which, if not avoided, may result in damage to
the device.
NOTE: used to call attention to notable information that should be followed during use.
Introduction
The User Manual provides instructions on how to operate GastroCH₄ECK® Gastrolyzer® and its
accessories. It contains relevant information about the monitor, its uses and its care, including step-
by-step instructions with screens and illustrations.
Intended Use
The GastroCH4ECK® Gastrolyzer® is a portable desktop monitor used to measure Hydrogen (H2),
Methane (CH4) and Oxygen (O2) levels in expired breath samples as an aid to screening and diagnosis
of gastrointestinal sugar and nutrient malabsorption.
The GastroCH4ECK® Gastrolyzer® is intended for multi-patient use by children and adults, measuring
expired breath samples acquired via a breath-bag for remote testing or using the mouthpiece and
sample line.
The GastroCH4ECK® Gastrolyzer® analyses a single patient sample at a time, interfacing with a PC to
allow a multi-patient sampling protocol to be performed and allowing further analysis of multiple
results by an appropriately qualified healthcare professional.
The GastroCH4ECK® Gastrolyzer® can be used as an aid in the screening and diagnosis of the
following disorders:
•Carbohydrate Breakdown Deficiency
•Carbohydrate Malabsorption
•Lactose Intolerance
•Bacterial Overgrowth
•Determination of time of passage through gut
The GastroCH4ECK® Gastrolyzer® diagnostic measurements obtained are intended to be reviewed by
an appropriately qualified healthcare professional and interpreted in conjunction with relevant
medical factors applicable to the sample provider, as an aid in assessment of appropriate treatment
or an aid to diagnosis of a condition. Specific diagnosis is not possible directly or instantly with this
device; further specific testing and symptom analysis would need to be carried out by a healthcare

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professional to diagnose a patient’s condition.
Contraindications
There are no known contraindications.
Compliance
Please refer to the following sections of this manual for more information on the compliance of the
GastroCH4ECK® Gastrolyzer® monitor
•Glossary of Symbols and Safety Information
•Environment
Instrument Layout
1. Sample line port
2. Breath bag port
3. Full-colour touchscreen
4. Mains power inlet
5. ON/OFF switch
6. Cooling fan
7. Exhaust
8. Outlet
9. USB port
10. Zero
11. Serial Number
12. Manufacturer label

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Parts and accessories
1. Sampling line
2. Mouthpiece
3. USB with GastroCHART™ software
4. Hydrogen Breath Tests book by Ledochowski
5. Breath bag
6. Face mask sampling system
7. Quick Start Guide
8. Blue plugs
9. Breath bag clips
10. Face mask
11. Patient Preparation guide
12. Moisture removal filter
13. Power cable
14. USB cable
15. Interpretation wheel
16. User manual

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Installation and Set-up
NOTE: The instrument should be calibrated prior to first use, after transportation, and every 4 weeks.
CAUTION: The GastroCH4ECK® should not be operated in an environment outside of the
temperature or humidity ranges stated in the technical specification.
1. Place the GastroCH4ECK® on a level surface with a 30cm (1ft) clearance envelope for
ventilation.
2. Connect the power cable to the GastroCH4ECK® via the socket on the rear of the monitor
and plug the other end into the mains.
3. Switch the monitor on using the ON/OFF switch at the back of the unit. The screen will light
up and if any warning screens are displayed, these should be checked in the Troubleshooting
section of the manual.
WARNING: When selecting an accessory for the GastroCH₄ECK® Gastrolyzer® monitor, please be
advised that an accessory not recommended by Bedfont® may result in loss of performance and may
compromise the safety of the device.
WARNING: The mouthpieces are single patient use only. Further re-use could cause incorrect
readings and could increase the risk of cross infection which may result in decreased accuracy of
results. The mouthpiece should be disposed of after use, in accordance with local waste disposal
guidance.

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User Interface
Home Screen
1. Start Breath Test button
2. Start Bag Test
3. Go to Settings Menu
Settings Menu
1. Go to Diagnostic Page
2. Start Calibration procedure
3. Go to Service Area
4. Home Button
NOTE: The Service Area is PIN protected and must
only be accessed by trained personnel:

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Breath Testing
Attach the sample line to the GastroCH4ECK® via the sample
connecter.
Then attach a new mouthpiece to the other end of the
sample line.
Press the breath test icon to begin.
A timer will be shown onscreen whilst the sensors are
zeroing. This may take up to 75 seconds if a test has just
been carried out.
NOTE: If GastroCHART™ is being used to record the readings,
on the patient’s profile click ‘capture reading’ now.
The inhale symbol will be shown onscreen for 3 seconds, to
prompt the user to take a deep breath.
The timer screen will be shown to prompt the user to hold
their breath for the 15 second countdown.

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A beep will sound during the last three seconds of the
countdown.
Exhale slowly into mouthpiece when prompted onscreen.
An on-screen dial will help to guide the exhalation rate; keep
the arrow pointing in the green section of this indicator
throughout the test.
The arrow will change colour as the O2level in the breath
sample reduces to the target 15%, at which point it will turn
green and the test will automatically stop after 3 seconds.
NOTE: If the patient is unable to exhale for any longer, the
test can be ended early by pressing END.
The results will be shown onscreen.
Once the test is complete, the final O2concentration can be
observed by pressing the question mark.

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This will show the O2concentration in % and the correction
factor applied to the reading if it was required. A visual
indicator will help to interpret the result:
a. Good test, little or no correction factor applied
b. Satisfactory test, correction factor applied
c. Poor test, high correction factor applied and
another test is recommended
Press the back arrow to return to the results screen.
When finished, press ‘HOME’ to return to the home screen.
NOTE: This will lose the reading; please ensure the results have been downloaded to GastroCHART™ or have been
recorded manually.
Remove the mouthpiece and sample line between tests to purge sensors with fresh air.
Analysing a Breath Bag Test
Attach the moisture filter to the device via the bag sample
connector.
Press the breath bag icon to start the bag test procedure.
The device will then illustrate to attach the breath bag.
Carefully remove the blue plug on one end only and attach
the bag to the moisture filter, then open the clamp on that
end only to preserve the sample.
Press the arrow to continue.

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A timer will be shown onscreen, whilst the sensors are
zeroing. This may take up to 75 seconds if a test has just
been carried out.
NOTE: If GastroCHART™ is being used to record the readings,
on the patient’s profile click ‘capture reading’ now.
Once zeroed, breath bag sampling will begin automatically –
make sure that the clamp is open. At this point, the device
needs no further intervention until a reading is recorded.
The device will draw the breath sample for analysis; this will
take 45 seconds, as indicated on the screen.
The results will be shown onscreen.
Once the test is complete, the final O2concentration can be
observed by pressing the question mark.
This will show the O2concentration in % and the correction
factor applied to the reading if it was required. A visual
indicator will help to interpret the result:
a. Good test, little or no correction factor applied
b. Satisfactory test, correction factor applied
c. Poor test, high correction factor applied and
another test is recommended
When finished, press ‘HOME’ to return to the home screen.

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NOTE: This will lose the reading; please ensure the results have been downloaded to GastroCHART™ or have been
recorded manually.
Remove the mouthpiece and sample line between tests to purge sensors with fresh air.
Maintenance
Routine maintenance
WARNING: Do not open the GastroCH4ECK® Gastrolyzer®, this could result in bodily harm.
NOTE: Servicing should only be carried out by a Bedfont® trained representative.
1. Mouthpieces should be replaced after every patient.
2. Hands should be washed regularly in accordance with infection control practice.
CAUTION: Do not use hand sanitising products containing alcohol as this may damage the
sensors.
3. The GastroCH4ECK® should be switched off once every 24 hours.
4. Only use accessories approved by Bedfont®.
CAUTION: Please do not attempt to modify the equipment in any way or use accessories
not specified by the manufacturer. Any attempt to do so, will invalidate the warranty and
may cause product failure or damage to your GastroCH₄ECK® Gastrolyzer® monitor. The
product warranty does not cover product failure or damage resulting from use with non-
approved accessories.
5. The device must be calibrated once every 4 weeks. See the ‘Calibration’ section of this
manual for instructions.
6. The monitor will provide daily reminders via the reminder screen after turning on the
GastroCH₄ECK® Gastrolyzer® for 1 month leading up to the sensor change due date. Once
this date has elapsed the date will turn red to indicate that sensor replacement is overdue:
a. The H2sensor should be replaced every 2 years.
b. The O2sensor should be replaced every 2 years.
c. The CH4 sensor should be replaced every 5 years.
CAUTION: Sensor use beyond the specified component lifetime without servicing may
compromise result accuracy.
NOTE: Bedfont® recommends an annual service in order to check sensor and component
parts performance.

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Cleaning
Bedfont® recommends wiping the instrument external surfaces with a product specifically
developed for this purpose. An EPA registered alcohol free disinfectant should be used, such
as Sani-Cloth AF3 Germicidal Disposable Wipe. Cleaning should be performed following the
instructions for use specified by the manufacturer of the EPA registered disinfectant. The
device or consumables cannot be sterilized. It is recommended that wipes are used once and
for one surface only. The GastroCH4ECK® Gastrolyzer® device should be cleaned for initial
use and after each patient use.
WARNING: Never use alcohol or cleaning agents containing alcohol or other organic solvents
as these vapours will damage the electrochemical sensor inside.
WARNING: Under no circumstances should the instrument be immersed or splashed with
liquid.
Calibration
The GastroCH4ECK® Gastrolyzer® should be calibrated every 4 weeks and will give a reminder during
start-up when calibration is due. The calibration gas required is 100ppm H2, 100ppm CH4and 20.9%
O2.
NOTE: Please allow the GastroCH4ECK® to be switched on for at least 5 minutes prior to calibration
NOTE: The GastroCH4ECK® device temperature needs to be at 21°C ± 4°C (69°F ± 39°F) to be able to
perform a calibration.
Open the settings menu and start the calibration process by
choosing the calibrate icon.

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First the monitor must be zeroed and this will happen
automatically.
NOTE: Do not connect the gas at this stage.
The temperature of the GastroCH4ECK® is above 25°C (77°F) and
is too hot to be calibrated. Please move the device to a cooler
area and try again later.
The temperature of the GastroCH4ECK® is below 17°C (62°F) and
is too cold to be calibrated. Please move the device to a warmer
area and try again later.
Once the zero is complete, follow the calibration process as
shown onscreen.
Verify calibration gas is the correct gas concentration.

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Screw the gas canister into the regulator.
Attach the CaliAdaptor to monitor via the sample line and open
the gas canister. Press the arrow to begin the calibration.
NOTE: Gas flow should be set to 1 litre per minute.
A successful calibration will be indicated by the green tick;
return to the home screen.

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A failed calibration will be indicated by the red cross; press the
retry icon to attempt calibration again. If the problem persists,
see ‘Troubleshooting’. Alternatively, return to the home screen.

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Technical Specification
GastroCH
4
ECK® Gastrolyzer®
Concentration range
CH
4
0-200 ppm
H
2
0-200 ppm
O
2
14-23%
Power input
230V/100V, 50Hz – 60 Hz, 0.5 – 1.0 A
Fuse
T 3.15 AH
Start-up time
≤2 minutes
Calibration frequency
Every 4 weeks
Display
Full colour touchscreen
Detection principle
Electrochemical sensor (O
2
& H
2
)
Laser (CH4)
Accuracy
CH4
Resolution
1 ppm
Accuracy
± 10% of reading
Repeatability
<5% difference on consecutive readings
H2
Resolution
1 ppm
Accuracy
± 10% of reading
Repeatability
<5% difference on consecutive readings
O2
Resolution
0.1%
Accuracy
± 10% of reading
Repeatability
<5% difference on consecutive readings
Carbon monoxide cross-sensitivity (H
2
only)
<4%
Temperature range
Operating
15-35°C (59°-95°F)
Storage
0-40°C (32°-104°F)
Pressure range
Operating
912-1114mbar (Atmospheric ±10%)
Storage
912-1114mbar (Atmospheric ±10%)
Humidity range
Operating
30-75% RH (non-condensing)
Storage
15-90% RH (non-condensing)
Expected sensor operating
life
CH
4
5 years
H
2
2 years
O
2
2 years
Dimensions
Approx. 474 x 310 x 135 mm
Weight
Approx. 8.5kg
Monitor construction and Materials
Case: aluminium
Mouthpiece: polypropylene
Face Mask Sampling System: polypropylene,
Styrenebutadieneplastic & silicone
Face Masks: polyvinyl chloride and polyethylene

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Classification and Regulatory Information
Class I ME equipment: (externally powered)
Type BF applied part
Method of sterilization (not suitable for sterilization)
Not suitable for use in an oxygen rich environment
Intended for continuous use
Response time
≤45 seconds
Warranty
2 years*
*Subject to maintenance and service.
NOTE: At 25°C (77°F) ambient temperature the expected lifetime of the unit is at least 30,000 hrs. For
every 10°C (50°F) rise in temperature, the lifetime is reduced by half.
Using the GastroCH4ECK® Gastrolyzer® with GastroCHART™
The GastroCH4ECK® Gastrolyzer® can be used with the GastroCHART™ software, which is a free
patient management software. GastroCHART™ software can be downloaded and installed from the
USB that comes with the GastroCH4ECK® Gastrolyzer®. Place one end of the USB cable into the USB
port at the rear of the GastroCH4ECK® and the other end to the USB port on the PC. Before starting
the software, ensure that the GastroCH4ECK® Gastrolyzer® is connected to the PC and switched on.
Double click the GastroCHART™ icon on the PC to start the programme. Refer to the GastroCHART™
manual for instructions on how to use the software.
Buttons
Breath
test
Home
Breath bag test
Settings
Next step
Log
Previous step
Calibration
Test
quality
Service area
(PIN protected)