Bedfont NOBreath User manual

Aids in the diagnosis & management of asthma,
one breath at a me.
User Manual
Fraconal Exhaled Nitric Oxide (FeNO) Monitor
NObreath
®

1
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.
Important Information/Reminders
NOTE: Only technical data and no patient data is collected by Bedfont®
NOTE: The NObreath® should be charged for a minimum of 24 hours before first use.
NOTE: The default PIN for the NObreath® is 0000. Bedfont® strongly advises that this PIN is changed
upon installation and set-up of the device.
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 10 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 vent holes on the device at any time. Blocking the vent holes may cause
erroneous readings.
WARNING: Do not allow the use of the NObreath® within 60 minutes of the following:
•Exercising
•Smoking
•Eating
•Drinking including Alcohol

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WARNING: Ensure the patient does not inhale through the mouthpiece.
WARNING: Ensure the patient does not exhale beyond the limits of their physical ability.
WARNING: Ensure the patient uses a single use mouthpiece for performing a breath test.
WARNING: The USB port is to be used for charging the NObreath® device, this should be carried out
via the supplied USB lead and also can be used for transferring encrypted patient data to and from
FeNOchart™PC Software. The NObreath® is not intended to be connected to any wireless adaptors
or any other USB Host.
CAUTION: Ensure the monitor is used within the stated operating temperature and humidity ranges.
Operating temperature is 15-30oC. Operating humidity is 20-80% RH (non-condensing).
CAUTION: Portable and mobile RF communications equipment can affect the NObreath®.
CAUTION: A great way to keep the NObreath® charged when not in use is to use the docking station
included. This can be connected via the pre-approved mains adapter supplied, or plugged into a
working USB port, to ensure the NObreath® has charge for when it’s needed. When connecting the
pre-approved mains adapter from the docking station to the mains power, please make sure that it
is plugged in to a mains location that is safe and easily accessible.
CAUTION: The NO scrubber contains potassium permanganate and should not be tampered with or
exposed to skin.
CAUTION: The NO scrubber contains potassium permanganate and should be disposed of as
hazardous waste in accordance with local waste disposal regulations.
NOTE: Ensure the patient inhales through the mouth, before exhaling through the mouthpiece.
NOTE: Bedfont® advise the NObreath® is charged monthly to ensure calibration data is not lost.
NOTE: When selecting an accessory for the NObreath® monitor, please be advised that an accessory
not recommended by Bedfont® may result in loss of performance and damage to the NObreath®
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: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B
is normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or
re-orienting the equipment.

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NOTE: Bedfont® will make available on request service training to appropriately qualified
personnel.

4
Contents
Definitions...........................................................................................................................................1
Important Information/Reminders.....................................................................................................1
Introduction ........................................................................................................................................5
Compliance .........................................................................................................................................5
Intended Use.......................................................................................................................................5
Contraindications................................................................................................................................5
Parts and accessories..........................................................................................................................6
Instrument Layout...............................................................................................................................7
Installation and Set-up........................................................................................................................8
User Interface ...................................................................................................................................10
Demo mode ......................................................................................................................................12
Performing a Breath Test..................................................................................................................14
Patient profiles..................................................................................................................................17
Maintenance.....................................................................................................................................21
Settings..............................................................................................................................................25
Data Reset.........................................................................................................................................34
Cybersecurity ....................................................................................................................................36
Technical Specification......................................................................................................................37
Using the NObreath® with FeNOchart™...........................................................................................38
Buttons Explained .............................................................................................................................38
Troubleshooting................................................................................................................................39
Glossary of Symbols and Safety Information....................................................................................48
Wireless.............................................................................................................................................50
Emissions...........................................................................................................................................52
Immunity...........................................................................................................................................53
Warranty...........................................................................................................................................54
Returns..............................................................................................................................................55
Responsible Manufacturer and Contacts..........................................................................................55

5
Introduction
The User Manual provides instructions on how to operate NObreath® FeNO monitor and its
accessories. It contains relevant information about the monitor, its uses and its care, including step-
by-step instructions with screens and illustrations.
Compliance
NObreath® is CE marked according to the Medical Device Directive 93/42/EEC.
NObreath® is RoHS compliant.
Please refer to the ‘Safety Information’ section of this manual for more information on the
compliance of the NObreath®.
Intended Use
The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric
Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in
inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a method to
measure the decrease in FeNO concentration in asthma patients that often occurs after treatment
with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in
patients with elevated FeNO levels.
The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according
to guidelines for NO measurement established by the American Thoracic Society.
NObreath® is intended for children, 7-17 years, and adults 18 years and older. NObreath® 12 second
test mode is for age 7 and up.
NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second
test.
FeNO measurements provide the physician with means of evaluating an asthma patient's response
to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in
asthma. The NObreath® cannot be used with infants or by children under the age of 7 as
measurement requires patient cooperation.
NObreath® should not be used in critical care, emergency care or in anesthesiology.
Contraindications
There are no known contraindications.

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Parts and accessories
1. NObreath® Dock
2. 1.8m USB cable
3. Mains plug and universal adaptors
4. NObreath® Forum information
5. Interpretation chart
6. NObreath® mouthpiece
7. Microfiber cloth
8. Quick Start Guide
9. Screwdriver
10. Infection Control Maintenance Guidelines
11. Patient Preparation
1
Quick Start
Guide
8
2
9
3
6
7
Infection Control Maintenance
Guidelines
NObreath® Forum
4
5
10
11

7
Instrument Layout
1. ON/OFF switch
2. Touchscreen
3. Mouthpiece aperture
4. Screw
5. Manufacturer label
6. Vent hole
7. Serial label
8. Vent hole
9. USB port
1
2
3
4
5
6
7
8
9
1

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Installation and Set-up
When setting up the NObreath®, please ensure the package contains all the parts as detailed in the
‘Parts and Accessories’ section of this manual. Please keep the screwdriver supplied for future
servicing requirements. The NObreath® should be charged for 24 hours prior to first use. Remove
the plastic film from the display and follow the next steps on how to charge the NObreath® below.
NOTE: The NObreath® should not be operated in an environment outside of the temperature or
humidity ranges stated in the technical specification.
The default PIN is 0000. It is strongly recommended to change this prior to first use –please refer to
the ‘Change PIN’ section of this manual for instructions.
When selecting an accessory for the NObreath® monitor, please be advised that an accessory not
recommended by Bedfont® may result in loss of performance and damage to the NObreath® device.
The product warranty does not cover product failure or damage resulting from use with non-
approved accessories.
WARNING: Please be advised that the NObreath® Mouthpiece is single-patient-use only. Re-use of
this mouthpiece can increase the risk of cross-infection and may result in decreased accuracy of
results.
How to charge the NObreath®
The NObreath® FeNO monitor comes with a Dock and charging cable to keep the monitor at hand
and fully charged.
NOTE: The NObreath® should be charged for a minimum of 24 hours before first use.
NOTE: It is best practice to not let the battery run flat. If the NObreath® does not switch on, or
displays the battery symbol on the last bar of charge, the NObreath® should be charged for 24 hours
prior to use.
To charge the NObreath®, first make sure the
micro USB cable provided is connected to the
docking station.

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Connect the other end of the micro USB cable
to the pre-approved mains adapter supplied,
using the appropriate universal adapter.
Plug the pre-approved mains plug into the
mains power.
CAUTION: When connecting the pre-approved
mains adapter from the docking station to the
mains power, please make sure that it is
plugged in to a mains location that is safe and
easily accessible.
When receiving power, the LED on the Dock will
light up green and the NObreath® can be placed
in the Dock to charge. If the LED light is red,
please see ‘Troubleshooting’.

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Place the NObreath® monitor into the Dock.
The screen will indicate that the monitor is
charging if powered off.
Alternatively, the NObreath® FeNO monitor can
be charged by plugging the micro USB cable
provided directly into the NObreath®. This can
then be connected either to the pre-approved
mains adapter or into a computer USB port.
User Interface
Home Screen
1. Information button
2. Battery status
3. Adult breath test
4. Child breath test
5. Demo mode
6. Patient profiles
7. Settings

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The information screen displays information about
the monitor and sensor.
Settings Menu Page 1
1. Date and time options
2. Test log
3. Change PIN number
4. Enable/disable PIN use
5. Change flow-meter style
6. Start ambient air test
7. Service Area
8. Home button
9. Go to Settings Menu Page 2
Settings Menu Page 2
1. Increase screen brightness
2. Decrease screen brightness
3. Enable/disable Bluetooth
4. Bluetooth pairing PIN
5. Go to Settings Menu Page 1

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Demo mode
The NObreath® has an in-built
demonstration video of the breath test
process. It is recommended to watch this
video prior to using the device for the first
time. This demo can also be used to explain
to patients how the test will run, prior to
performing one.
Press the demo icon to begin.
Select either the adult or child patient.
The zero screen will briefly display as in a
real test.

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A demonstration will run through the
breath test process.
The whole test will be shown, but at an
accelerated speed.
Only a successful test will be demonstrated.

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Once the result is displayed, the demo is
complete.
Press the home icon to return to the home
screen.
Performing a Breath Test
Open and insert a new mouthpiece into the
NObreath® monitor.
To start a breath test, select either the adult
or child patient.
As prompted onscreen, take a deep breath.
WARNING: Do not inhale through the
mouthpiece.
NOTE: Ensure the patient inhales through
the mouth, before exhaling through the
mouthpiece.
Press the home button at any time to
cancel the breath test.

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When the exhale icon displays, keep the
monitor upright and blow gently into the
mouthpiece.
NOTE: Make sure the vent holes are not
covered.
The exhalation time is approximately 12
seconds for an adult and 10 for a child.
The onscreen flow meter will guide the patient on the exhalation rate:
Keep the
car in the middle
of the road.
Keep the dial
in the green area.
Keep the
car in the middle
of the road.
Follow the bubbles.
A green tick onscreen indicates a successful
test.

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The results will then be shown onscreen in
ppb.
Return to the home screen by pressing the
home button or save the result to a patient
profile.
If the patient exhales outside of the
exhalation guidelines, the test will beep
before indicating a fail and a red cross will
appear.
Press the retry icon to retake the test or the
next arrow to view the result.

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Patient profiles
The NObreath® is designed to be capable of
storing up to 25 results in up to 50 patient
profiles.
Press the profiles icon to access patient profiles.
If the PIN has not been entered in the last 30
minutes, the 4-digit code will be required before
the patient profiles can be accessed.
NOTE: If the PIN has been forgotten, please
contact Bedfont® or its local distributor to reset it.
A list of patient profiles will show onscreen.

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Create a new patient profile
To create a new profile, choose an empty name
slot.
Use the keypad to enter a name or reference.
Click the save icon to create the profile.
To cancel, press the back arrow to return to the
list of profiles or the home icon to return to the
main screen.
Once the profile has been created the following
options will become available:
1. See a graph of results
2. Delete the patient profile
3. Take an adult breath test
4. Take a child breath test
5. Return to the profile list
6. Return to the main screen

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Once an adult or child breath test has been
selected, the profile will only offer that breath test
mode in future.
It is not possible for the user to save an adult
breath test to a child’s profile, or a child’s breath
test to an adult’s profile. Profiles not compatible
with the breath test will be shown in blue.
Edit a patient profile
To edit a patient’s profile, select their name/ID
from the list.