Bedfont Gastro+ Gastrolyzer User manual

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

1
Important Information/Reminders
NOTE: Only technical data and no patient data is collected by Bedfont®.
WARNING: Please read the manual before 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.
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 and can be used for a maximum of 3 tests.
Further re-use could cause incorrect readings and could increase the risk of cross infection. The
mouthpiece should be disposed of after use, in accordance with local waste disposal guidance.
WARNING: Patients should exhale for the duration of time indicated by the monitor during a breath
test. Failure to do so may cause incorrect readings.
WARNING: To ensure a breath sample is taken at the correct flow rate, the monitor must be held
upright at all times during a breath test.
WARNING: Do not block the exhaust ports on the device at any time. Blocking the exhaust ports may
cause erroneous readings.
CAUTION: Ensure the monitor is used within the stated operating temperature and humidity ranges.
Operating temperature is 15-35oC. Operating humidity is 25-80% RH (non-condensing).
CAUTION: Portable and mobile RF communications equipment can affect the Gastro+™ Gastrolyzer®
monitors.
NOTE: When selecting an accessory for the Gastro+™ Gastrolyzer® monitor, please be advised that
an accessory not recommended by Bedfont® may result in loss of performance and damage to your
Gastro+™ Gastrolyzer® device. The product warranty does not cover product failure or damage
resulting from use with non-approved accessories.
NOTE: See Bedfont’s infection control and maintenance guidelines for further information on
infection control.
NOTE: 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 compromise the
safety of the device.
NOTE: Bedfont® will make available on request service training to appropriately qualified personnel.

2
Contents
Important Information/Reminders.....................................................................................................1
Introduction ........................................................................................................................................3
Definitions...........................................................................................................................................3
Compliance .........................................................................................................................................3
Intended Use....................................................................................................................................... 4
Contraindications................................................................................................................................4
Instrument Layout............................................................................................................................... 4
User Interface ..................................................................................................................................... 5
Taking a breath test ............................................................................................................................6
Taking a face mask test.....................................................................................................................10
Conducting multi-patient breath tests .............................................................................................13
Patient Profiles..................................................................................................................................18
Protocol pre-set timings....................................................................................................................21
Edit protocol timings.........................................................................................................................21
Edit protocol names.......................................................................................................................... 23
Protocol pre-set thresholds ..............................................................................................................26
Edit protocol pre-set positive thresholds .........................................................................................27
Reviewing history.............................................................................................................................. 29
Changing date and time ....................................................................................................................30
Technical Specification...................................................................................................................... 32
Safety Information ............................................................................................................................32
Environment .....................................................................................................................................33
Display symbols.................................................................................................................................35
Maintenance .....................................................................................................................................37
Calibration......................................................................................................................................... 38
Troubleshooting................................................................................................................................42
GastroCHART™ software – connecting to the PC .............................................................................42
Returns procedure ............................................................................................................................ 43
Spares................................................................................................................................................44
Warranty ...........................................................................................................................................45
References ........................................................................................................................................45
Responsible Manufacturer and Contacts..........................................................................................45

3
Introduction
H2is generated in the intestinal lumen by bacterial action on carbohydrates in the small or large
intestine. Once the resultant H2is diffused into the bloodstream it is transported to the alveoli and
then can be detected in expiratory air. Levitt1demonstrated the correlation between intestinal
lumen H2production and H2excretion in expiratory air. Accurate measurement of H2in parts per
million (ppm) in expiratory air reveals intolerance and/or malabsorption of carbohydrates; or
bacterial overgrowth.
Operation of the monitor is straightforward. A D-piece™ sampling system enables end-expired
breath to be sampled easily and hygienically, using single-use disposable SteriBreath™ mouthpieces
and disposable face masks.
The Gastro+™ can be used to aid in the diagnosis of the following disorders:
• Carbohydrate intolerance
• Carbohydrate malabsorption
• Intestinal bacterial overgrowth
• Investigation of intestinal transit time
Definitions
WARNING: indicates a potentially hazardous situation, which, if not avoided, may result 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.
Compliance
The Gastro+™ Gastrolyzer® monitor is CE marked according to the Medical Device Directive
93/42/EEC.
Please refer to the ‘Safety Information’ section of this manual for more information on the
compliance of the Gastro+™ Gastrolyzer® monitor.

4
Intended Use
The Gastro+™ Gastrolyzer® is a breath hydrogen (H2) monitor used to measure hydrogen levels in
expired breath. It is intended for multi-patient use by healthcare professionals in a clinical
environment.
Contraindications
There are no known contraindications.
Instrument Layout
1. Display
2. Power button
3. Breath sampling D-piece™
4. D-piece™ aperture
5. Exhaust port for breath sample
6. USB connector (for use with
GastroCHART™ software)
7. Single-use SteriBreath™
mouthpiece
8. Battery compartment
9. Battery compartment clip
10. Reset button
11. Programming switch
12. USB cable (1.0m)

5
User Interface
Home Screen
1. Battery status
2. Face mask breath test
3. Normal breath test
4. Multi-patient air test
5. Patient profiles
6. Settings
1
2
3
4
5
6

6
Taking a breath test
Attach a breath sampling D-piece™ and SteriBreath™
mouthpiece.
Turn on the monitor by pressing the power button once.
Press the breath test icon on screen.

7
If the timer is shown, the sensor is stabilising.
Inhale and hold breath for the pre-set 15 second countdown as
shown on screen. If unable to hold breath for full 15 seconds,
the timer can be adjusted in the settings.
Press the home button at any time to cancel the breath test.

8
A beep will sound during the last three seconds of the
countdown.
Blow slowly into mouthpiece, aiming to empty lungs
completely.

9
The ppm will rise and hold onscreen.
When the test is finished, the breath test, home and save icons
will appear at the bottom of the screen.
To repeat breath test, press the breath test icon and repeat
steps.
To return to the home screen, press the home icon.

10
To save the reading, press the save icon and select the relevant
patient profile.
Remove the D-piece™ between tests to purge sensor with fresh air.
To switch off, press and hold the power button for 3 seconds, unit will also power off after 45 minutes of
inactivity to save power.
Taking a face mask test
Attach a new face mask sampling system.
Turn on the monitor by pressing the power
button once.
Press the face mask breath test option.

11
If the timer is shown, the sensor is
stabilising.
Inhale and exhale into the face mask, the
device will take the reading in real-time.

12
The ppm levels will rise and hold at the
peak level, when this has stopped rising for
a period of 5 consecutive seconds the test
result can be recorded and the test
stopped.
When the test is finished, the face mask
breath test, home and save icons will
appear at the bottom of the screen.
To repeat breath test, press the face mask
breath test icon and repeat steps.
To return to the home screen, press the
home icon.
Remove the face mask sampling system between tests to purge sensor with fresh air.
To switch off, press and hold the power button for 3 seconds, unit will also power off after 45 minutes of
inactivity to save power.

13
Conducting multi-patient breath tests
WARNING: Ensure batteries are full or device is connected to computer USB port (it will be powered by the
USB). If the device loses power during the automatic testing mode only saved results will remain on the
device and the protocol timings will be lost.
The Gastro+™ Gastrolyzer® allows automatic testing for up to 10 patients in one session to be set up, which
can be very time-saving in a busy clinic. This can be done by following these steps:
Press the multi-patient icon on the main
screen; this will go to the patient database
screen, where patients can be selected that
have been previously added. To add
patients follows instructions in ‘adding a
patient profile’ section of this manual.
Up to 10 patients can be selected for testing
simply by pressing their name slot. Selected
patients will change from pink to green
when selected, to deselect them press the
name slot again and it will return to pink.
Once the desired patients have been
selected, press the right arrow at the
bottom of the screen to progress to the
protocol screen.

14
Select the protocol for each patient; their
name will be shown at the top of the screen.
Select the protocol by pressing the protocol
name, for example ‘lactose’, when selected
the protocol will change to green. To edit
the protocol timings please see ‘edit testing
Protocols’ section of this manual.
Press the right arrow at the bottom of the
screen to progress to the next patient.
When the final protocol has been selected
and when selecting a patient during testing,
three options will appear for the first
patient. Their name will be shown at the top
of the screen.
To perform a breath test (please note: if this
is the base sample no substrate/sugar
should be given to patient before this point)
press and follow steps 4-8 of the ‘taking a
breath test’ section of this manual.
To perform a face mask test (please note: if
this is the base sample no substrate/sugar
should be given to patient before this point)
press and follow steps 3-6 of the ‘taking a
face mask test’ section of this manual.

15
If the test is unsuccessful in any way, take
the test again by pressing the back arrow on
the result screen, this will overwrite the
previous result.
To save this reading to the patient profile,
press the save icon.
This is the base sample; once the result has
been saved, a prompt will appear to give the
patient the relevant substrate/sugar.
Once the patient has done this, press the
right arrow to continue with the next
patient, this will also start the next breath
test timer for the previous patient.
The device will prompt the next patient,
tested in the same way.

16
When the final patient has provided a
sample and taken the substrate/sugar, a
screen will show all the patients in the
testing session with countdown timings for
each patient until their next test.
When the timer for a patient reaches zero,
an alarm will sound indicating the next test
is ready to be taken and the patient name
will turn green.
Take the next reading for that patient by
pressing their name and following above
instructions.
Once each patient has finished their testing
protocol, their name slot will turn green and
the readings will be saved in the profile.
The amount of tests performed and how
many are left for any given patient can be
viewed by selecting the profile in the session
screen.
If the results are satisfactory before the
protocol session has finished, the session
can be ended early by selecting the profile
in the session screen and pressing the
number of tests icon.

17
Confirm the action by pressing the same
icon on the next screen.
Once the complete patient session has
finished, all name slots will show as green.

18
Return to the home screen in order to view
results by pressing the profile icon.
Results can be downloaded to GastroCHART™ for future reference or printing, follow instructions in
‘GastroCHART™ software’ section of this manual.
Patient Profiles
The Gastro+™ Gastrolyzer® allows up to 10 patient profiles to be set-up on the device in order to record
readings to a specific patient profile and then downloaded later using GastroCHART™. This can be done by
following the steps below:

19
Press the patient profile icon on the home
screen.
Press a patient profile to go to the edit
screen.