Bedfont NOBreath User manual

Our family, innovang health, for yours.
est. 1976
User manual

1
NObreath®user manual
English
www.bedfont.com
Contents
1 Intended use 2
2 Introduction 2
3Product description 2
4 Warnings 3
Contraindications 3
Caution 3
5 Pack contents list 4
6 Specification 5
7 Instrument layout 6
8 Display symbols 7
9 Maintenance 8
Cleaning 8
10 Operation 8
Performing a breath test 9
Ambient NO test 9
11 Settings 10
Sounder 10
Date and time 10
System information 10
Servicing 10
Further information 10
12 Troubleshooting 11
13 Returns procedure 12
14 Spares 13
14 References 13
15 Warranty 13

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NObreath®user manual
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Intended use
Introduction
The NObreath®is a breath nitric oxide (NO)
test system intended to measure fractional
exhaled nitric oxide (FeNO) in parts per
billion (ppb) in exhaled breath. For use
by healthcare professionals, it is intended
for use in a healthcare environment and
should be used in conjunction with other
clinical and laboratory evaluation where
appropriate.
The production of nitric oxide is often found
to be higher in inammatory conditions
such as asthma and can therefore be used
for the detection and management of such
conditions1. Nitric oxide measurement is
not intended as a stand alone method
for diagnosis and should be used in
conjunction with other evaluation methods
and tests2.
Product Description
The NObreath®is a hand-held breath nitric
oxide monitor.
The measurement system is based on
electrochemical sensor technology, which
has been specically designed for this
application. The sensor reacts to the
presence of nitric oxide producing an
electrical output. The sensor has nitric
oxide free air owing into the sensor
chamber while the unit is on but not in the
breath test mode.
The NObreathFlo has been specically
designed in order to meet the breath
test guidelines described in the ATS/
ERS Recommendations. The ATS/ERS
Recommendations are standardized
procedures for the online and ofine
measurement of exhaled upper respiratory
nitric oxide and nasal nitric oxide.
The patient shall exhale at 50ml/sec, into
the mouthpiece (applied part) using the
NObreathFlo sample system connected the
instrument, until a reading is displayed.
The NObreath®is also capable of
performing an ambient air test as required.

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NObreath®user manual
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Warnings
●Please read the manual before use.
●Never use alcohol or cleaning agents
containing alcohol or other organic
solvents as these vapours will damage
the electrochemical sensor inside.
●Under no circumstances should the
instrument be immersed or splashed
with liquid.
●The battery life is indicated by the green
icon. When the amber icon
is displayed the batteries should be
changed.
●Check for battery leakage before use,
after extended periods of storage.
●Breath tests must only be carried out
with Bedfont accessories. Failure to do
so may cause incorrect readings.
●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.
●Patients should exhale for the duration
of time indicated by the monitor during a
breath test. Failure to do so may cause
incorrect readings.
●To ensure a breath sample is taken
at the correct ow rate, the monitor
must be held upright at all times
during a breath test. The ball in the
NObreathFloTM should be kept within
the white band in the centre of the tube
during a test.
●The mouthpiece may become warm to
the touch after use.
●The NObreathFloTM should be used for
50 patients only, then disposed. A new
NObreathFloTM is provided with each
pack of 50 mouthpieces.
●Do not block the exhaust port on
the device at any time. Blocking the
exhaust port may cause erroneous
readings.
●See Bedfont’s infection control and
maintenance guidelines for further
information on infection control.
●Please do not attempt to modify
the equipment in any way or use
accessories not specied by the
manufacturer. Any attempt to do so,
will invalidate the warranty and may
compromise the safety of the device.
●Bedfont®will make available on request
service training to appropriately qualied
personnel
Contraindications
●The sensor has some cross-sensitivities
to breath gases. These are low and
should not affect readings. Please
contact Bedfont®for more information.
Caution
●Ensure the monitor is used within the
temperature and relative humidity (Rh)
range as stated in the specication on
page 5.
●Portable and mobile RF communications
equipment can affect the NObreath®.
●Federal law restricts this device to sale
by or on the order of a physician (USA
only).

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NObreath®user manual
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1
2
54
3
Pack contents list
Instrument
Operation instructions
AA batteries
Mouthpieces
NObreathFloTM
Infection control and maintenance
guidelines
1
2
5
4
3
Instrument cleansing wipes
BreathGAS CD
Cleaning cloth
Stylus
A5 chart
Quick start guide
6
7
8
11
10
9
12
10
9
8
6
7
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User manual
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11
12

5
NObreath®user manual
English
www.bedfont.com
Specication*
Exhaled ow during FeNO measurement at 50mls/sec ±10% at 10cm H2O.
*Bedfont® reserve the right to update this specication without notication. ** Subject to servicing.
:The NObreath®complies with the directive EN60601-1-2 electromagnetic compatability but can be affected by
celular phones and by electromagnetic interference exceeding levels specied in EN50082:1. This equipment should be moved if
necessary to avoid interference.
Please refer to the warnings and safety notes in this
manual
CE mark Manufacture by and date
Dipose of according to WEEE
Symbols Direct current
Internally powered equipment
NObreath®
Concentration range 5-300ppb
Display Colour LCD with touchscreen
Detection principle Electrochemical sensor
Repeatability ± 5ppb of measured value ≤50ppb
± 10% of measured value >50ppb
Accuracy ± 5ppb of measured value ≤50ppb
± 10% of measured value >50ppb
Power 3 x AA (LR6 or equivalent) up to 120 tests
2 x CR2032 lithium coil cell
T90 response time <10 seconds
Operating temperature 10-30ºC
Storage/transport temperature 10-30ºC
Storage/transport/transport pressure Atmospheric ±10%
Operating humidity 10-80% (non-condensing)
Storage/transport humidity 25-75%
Sensor operating life 5 years**
Sensor sensitivity 5ppb
Sensor drift <5% per annum
Dimensions Approx. 152 x 87 x 47mm
Weight Approx. 400g (including batteries)
Materials Case: polycarbonate/ABS blend with elastomeric
overmould
NObreathFloTM: polycarbonate/ABS blend
Mouthpiece: polypropylene
Breath test time Adult 12 seconds/child 10 seconds
Warm-up time <60 seconds
Ambient air test 30 seconds
Maximum ambient operating level 350 ppb NO
Consult instructions
for use.

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NObreath®user manual
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Instrument layout
Display
On/off button
Aperture for NObreathFloTM
NObreathFloTM
NObreath®mouthpiece (applied part)
Exhaust port for breath sample
Sounder outlet
Battery compartment
8
4
3
2
7
1
1
2
5
4
3
6
7
8
5
6

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NObreath®user manual
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www.bedfont.com
1. Start-up screen:
2. Battery condition
red, amber, green
3. Sounder: on off
4. Start breath test: Adult Child
5. Start ambient air test:
6. Settings:
7. Return to main menu:
8. Return to previous menu:
9. Inhale:
10. Exhale for breath test:
11. Progress bar
12. Final reading:
13. Calibration menu:
Display symbols
14. Perform zero check:
15. Calibration (unavailable):
16. Pump Speed (unavailable)
17. Acknowledge
zero/calibration: pass fail
18. Set date/time:
19. System info screen:
20. Contact Bedfont®or distributor
for help:
21. Service reminder:
v2.2
S/N NBR000000

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NObreath®user manual
English
Maintenance
Cleaning
●Wipe the instrument and external
NObreathFloTM surfaces with a product
specically developed for this purpose.
Bedfont®provides instrument cleansing
wipes.
●Never use alcohol or cleaning agents
containing alcohol or other organic
solvents as these vapours will damage
the electrochemical sensor inside.
●The NObreath®should be calibrated
annually.
●The NO sensor and pump should be
replaced every 5 years.
●The mouthpieces are single patient use
only and should be replaced between
tests.
●Replace batteries when indicated.
●Replace the NObreathFloTM every 50
patients.
●It is recommended that batteries are
left in the monitor at all times, even
when not in use to prevent loss of
bias voltage to the sensor.
1
Check for battery leakage before
use, after extended periods of
storage.
●Never open the unit or attempt to
service the unit without prior training
from Bedfont®. Doing so will invalidate
the warranty and performance cannot
be guaranteed.
●Additional technical information can
be made available on request; please
contact Bedfont®or its distributor.
The main menu displays four symbols:
Child breath test
Adult breath test
Ambient air test
Setting menu
Operation
1
2
3
Ensure 3 good quality AA alkaline batteries
are correctly located in the battery
compartment.
The touchscreen controls all functions once
the instrument is switched on.
Press the on/off button until the display
becomes active. Release the button.
The device start-up takes 60 seconds,
during which time the start-up screens
are displayed. During this time the unit
is performing a zero measurement by
pumping NO free air into the sensor
chamber. Ensure the exhaust port is not
blocked.
4
Bedfont®will make available
upon request service training to
appropriately qualied persons.
●Under no circumstances should the
instrument be immersed in liquid or
splashed with liquid.

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NObreath®user manual
English
www.bedfont.com
Performing a breath test
To perform a new breath test attach a
new mouthpiece to the NObreathFloTM.
Once secured, attach the NObreathFloTM.
and mouthpiece to the device. Ensure all
connections are pushed rmly together.
The monitor must be held upright at all
times during a test.
The screen will guide the patient through a
breath test from the icons on the screen.
To start a breath test, touch the or
icon. The unit will beep once.
The or icon will appear, during
which the patient should take a comfortable
inhalation of air (not through the
mouthpiece).
After 3 seconds, the icon shall change
to or and the unit shall give a
double beep to signal that the patient
should start to exhale. The patient should
then exhale through the mouthpiece and
NObreathFloTM, ensuring that the ball in the
ow indicator is held in the middle of the
band on the NObreathFloTM.
The exhalation time is approximately 12
seconds for an adult and 10 seconds for a
child, a progress bar is shown at the bottom
of the screen. Patients should continue to
exhale until the progress bar has reached
its limit, double beep sounds, and then the
reading is displayed in ppb (see warnings,
page 3).
After a patient test has been completed,
remove the NObreathFloTM and mouthpiece
from the NObreath®and then remove and
dispose of the mouthpiece safely. This
should be done in accordance with local
waste disposal guidance.
The icon shall appear at the end of
the test, 60 seconds after the reading is
displayed. This allows time for the sensor
to settle to zero before the next test. Touch
to return to the main menu.
To start another patient breath test, t a new
mouthpiece and touch the or icon.
If no further tests are required, press and
hold the on/off button for 3 seconds then
release to turn off. If left on, the NObreath®
will automatically turn off after 5 minutes of
inactivity.
To view the last reading taken on the
instrument, go to the System Information
screen. See page 10 for details.
Ambient NO test
The NObreath®can measure the level of
nitric oxide in the surrounding ambient air.
This is important as the NObreath®has
been designed to function in environments
containing less than 350ppb NO.
Ensure the NObreathFloTM is not
connected.
Touch the icon to start a test.
The ambient air reading shall be displayed
after 30 seconds.
The icon shall appear at the end of
the test, 60 seconds after the reading is
displayed. This allows time for the sensor
to settle to zero before the next test. Touch
to return to the main menu.
If no further tests are required, press and
hold the on/off button for 3 seconds then
release to turn off. If left on, the NObreath®
will automatically turn off after 5 minutes of

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NObreath®user manual
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Settings
Touch the icon to access the following
functions.
●Sounder
●Set date/time
●System information
●Zero/calibration
Sounder
The status of the sounder is indicated by
the small symbol on the top line of the
display.
To change from sounder-on to sounder-off
(or back again), touch the large icon
in the settings menu. The large sounder
symbol and the small symbol on the top line
of the display will change to show whether
the sounder is on or off.
Even if the sounder has been turned off, it
will continue to operate during the breath
test process.
Date and time
To change the date and time, touch in
the Settings menu.
Touch the required eld and use or
to change.
Press to save or to cancel. Return
to main menu.
System information
Touch to access system information.
This screen provides information on: the
software version number; the last reading
taken ; the date the unit was last
calibrated at Bedfont®, the number of breath
tests taken and the serial number. Touch
to return to the main menu.
Servicing
●Calibration should only be undertaken
by Bedfont®. Any third party attempt
to calibrate the unit could result in
inaccurate readings and invalidate
warranty.
●Batteries should always be replaced
with good quality AA batteries when the
amber icon is displayed.
●The icon will show when this
service is required.
●Press to continue to the main
menu.
●Any consumables will be replaced, if
necessary, during the yearly service.
This may include replacing the sensor.
Further information
●The NObreathFloTM is replaceable after
50 patients have been tested. A new
NObreathFloTM is supplied with every
pack of 50 mouthpieces.
●The minimum time between breath tests
for a single patient is two minutes.

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NObreath®user manual
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If the unit fails to turn on properly, or if the
low battery symbol is showing, replace the
3 x AA alkaline batteries. Ensure that the
batteries are inserted correctly, matching
the symbols moulded into the plastic.
If the display shows after zeroing, a
second attempt can be made. Check that
the unit is in fresh air and touch to
restart the zero process. If, after a third
zeroing attempt, the display shows
again, the unit will have to be returned to
Bedfont®or its distributor for investigation
and repair. In this case, the display shows
. The unit can be turned off by
holding the on/off button for three seconds
then releasing. It is possible to re-start the
unit and attempt the zeroing process again.
Troubleshooting

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NObreath®user manual
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The NObreath®requires servicing every 12 months. The servicing shall be carried out
by Bedfont®alone. Please contact bedfont’s customer service specialist before returning
any goods. If equipment was not purchased direct from Bedfont®, please contact the local
distributor.
●When the monitor serial number
(located on the information screen and
in the battery bay) and description of the
fault have been supplied, the customer
repairs department will issue a returns
number.
●State this number when returning the
monitor, ensuring full details, including
telephone and fax numbers, are clearly
provided.
●Bedfont®advise using a courier service
and not local postal services when
returning monitors.
●Conrmation will be sent when goods
are received.
●An engineer’s report and a quotation
for the repair will be sent following
investigation. This includes an
authorisation form.
●If the monitor is still within warranty,
Bedfont®will repair and return it with
an engineer’s report, free of charge. If,
after inspection, no fault is found, a fee
will be charged.
●If outside of warranty, complete the
authorisation form within the quotation
to proceed with the repair or calibration.
Ensure an ofcial purchase order
number is included, and return to
Bedfont®. Contact the customer repairs
department with any queries.
●If it is decided not to proceed with the
repair, a handling fee will be charged.
Ensure the completed authorisation
form is returned with an ofcial
purchase order number.
●The equipment will be returned as
soon as Bedfont®have received all the
relevant paperwork. A carriage fee will
be charged if the monitor is no longer in
warranty.
●Return the unit in the original packaging,
in the sealed container.
Returns procedure
A return ticket can also be opened at www.bedfont.com/support_ticket

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NObreath®user manual
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Spares
The above spares are available from Bedfont®UK. For spares availability in all other
countries, contact your local distributor. To ensure continued accuracy, only Bedfont®
spares should be used.
Bedfont® Scientic Limited warrants the
NObreath®(batteries excepted) to be free
of defects in materials and workmanship
for a period of two years from the date of
shipment. Bedfont’s sole obligation under
this warranty is limited to repairing or
replacing, at its choice, any item covered
under this warranty when such an item is
returned intact and prepaid, to Bedfont®or
the local representative.
Warranty
References
Note: Sensors are guaranteed for a period
of six months from the date of shipment from
Bedfont®.
The product warranty is automatically
invalidated if the security seal is broken
or if the products are repaired, altered or
otherwise tampered with by unauthorised
personnel, or have been subject to misuse,
neglect or accident.
Part number Description
NTK-50 NObreathFloTM and 50 mouthpieces
WIPES Non-alcoholic instrument cleansing wipes
BAT048 AA alkaline batteries x 3
Never dispose of any electronic instrument or batteries in domestic
waste. At the end of the product’s life, contact Bedfont®or its distributor
for disposal instructions.
Single use consumables and accessories should be disposed of in line
with local clinical waste guidelines.
1 14. Saito J, Gibeon D, Macedo P, Menzies-Gow A, Bhavsar P, Chung K. Domiciliary diurnal variaon of exhaled nitric oxide
fracon for asthma control. 2017.
2-13. Correlaon of Exhaled Nitric Oxide, Spirometry and Asthma Symptoms: Journal of Asthma: Vol 42, No 10 [Internet].
Tandfonline.com. 2017 [cited 15 March 2017]. Available from:
hp://www.tandfonline.com/doi/abs/10.1080/02770900500371344

est. 1976
Bedfont® Scientic Ltd.
Station Road, Harrietsham, Maidstone,
Kent, ME17 1JA England
Tel: [phone] Fax: [phone]
Email: [email protected]
Issue 14- December 2017, Part No: LAB350
Bedfont® Scientic Limited reserves the right to change or update this literature without prior notice.
Registered in: England and Wales. Registered No: 1289798
© Bedfont® Scientic Limited 2017
Our family, innovang health, for yours.