Spirosure FenomPro User manual

IFU-3264 Rev B Instructions for Use, Fenom Pro
Asthma Monitor
Instructions for Use

IFU-3264 Rev B Instructions for Use, Fenom Pro
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Table of Contents
Table of Contents 2
Denitions 4
Chapter 1: System Overview 5
System Description 5
Indications for Use 5
Clinical Limitations 5
Risks to Health 5
Fenom Pro Components 6
Table 1: Fenom Pro Device Components 6
Display Buttons 7
Table 2: Button and Indication Icons 7
Chapter 2: Safety and Warnings 8
Safety Instructions 8
Compliance 8
Warnings 8
Electromagnetic Emissions 9
Electromagnetic Immunity 9
Chapter 3: Fenom Pro Quick Start Guide 10
Chapter 4: FeNO Measurement Preparation 12
Wake up Device 12
Pre-test Check 12
Chapter 5: Perform FeNO Measurement 13
Perform an Adult FeNO Test 13
Perform a Child FeNO Test 14
View Results 15
Remove Mouthpiece 15
Chapter 6: Power O Device 16
Chapter 7: Practise Mode 16
Chapter 8: Device Set-up 17
Initial Set-up 17
Conguration Settings 18
Device Settings 18
Time/Date 18
Language 18
System Information 19
Test Incentive Sound 19
Add Tests 19

IFU-3264 Rev B Instructions for Use, Fenom Pro 3
Chapter 9: General Care 20
Operating Conditions 20
Cleaning 20
Handling 20
Storage 20
Preventive Inspections 21
Rechargeable Battery 21
Maintenance 21
Disposal of Used/Expired Equipment and Consumables 21
Limited Warranty 21
Chapter 10: Troubleshooting 22
Support 22
Add Tests 22
Errors and Codes 23
Table 4: Error Codes 23
Chapter 11: Technical Data 26
Dimensions and Weight 26
Electrical Data 26
Exhaled NO Performance 26
Linearity 26
Precision 26
Accuracy 26
Limit of Detection 26
Measurement Range 26
Exhalation Parameters 26
Chapter 12: Reference 27
Symbol Explanation 27
Chapter 13: Parts and Accessories 28
Parts 28
Accessories 28
Bibliography 29

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Denitions
FeNO Fractional exhaled Nitric Oxide – Amount of nitric oxide in the exhaled breath originating
from the bronchial passages, not the nasal passages or upper airway.
FEV1 Forced Expiratory Volume in One Second – Volume of air that can be forcibly exhaled from
the lungs in the rst second of a forced expiratory manoeuvre, measured in litres.
FEV6 Forced Expiratory Volume in Six Seconds – Volume of air that can be forcibly exhaled from
the lungs in the six seconds of a forced expiratory manoeuvre, measured in litres.
FVC
Forced Vital Capacity – After the patient has taken in the deepest possible breath, this is the
volume of air that can be forcibly and maximally exhaled out of the lungs until no more can
be expired, usually measured in litres.
NO Nitric oxide – Produced by the human lung and present in the exhaled breath. It has been
implicated in the pathophysiology of lung diseases, including asthma.
PEF Peak Expiratory Flow – Maximal ow (or speed) achieved during the maximally forced
expiration initiated at full inspiration, measured in litres per minute or in litres per second.
Spirometry Common oce test used to assess how well a patient’s lungs work by measuring how much
air is inhaled, how much is exhaled, and how quickly it is exhaled.
The following are the denitions for terms and abbreviations used in this manual

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Chapter 1: System Overview
System Description
The Fenom Pro™ Asthma Monitor (henceforth known as Fenom Pro) is a point-of-care breath analyser that uses
electrochemical technology to measure the fraction of exhaled nitric oxide (FeNO), a marker for airway inammation, in
human exhaled breath.
Measurement of FeNO by Fenom Pro is a quantitative, non-invasive, simple, and safe method to assess, monitor, and
determine the best treatment methods for airway inammation in patients. The Fenom Pro device is suitable for use in
hospitals and other healthcare settings. The mouthpiece is the applied part for patient use.
Fenom Pro is designed as a hand-held device for measuring FeNO in exhaled breath from humans. The level of
exhaled nitric oxide (NO) is frequently increased in some inammatory processes such as asthma. The fractional
NO concentration in expired breath can be measured by Fenom Pro according to guidelines for NO measurement
established by the American Thoracic Society (ATS) and European Respiratory Society (ERS) [1].
Fenom Pro provides direct sampling with delayed analysis (approximately 28 seconds) of sequentially collected and
analysed exhaled breath. No subsequent specic specimen collection, specimen preparation, or reagents are required.
The emissions characteristics of the Fenom Pro device make it suitable for use in hospitals and other healthcare
settings (CISPR 11 class A).
Indications for Use
Fenom Pro measures FeNO in human breath. FeNO is increased in some airway inammatory processes, such as
asthma, and decreases in response to anti-inammatory treatment [1]. FeNO measurements with Fenom Pro should
be used as part of regular assessment and monitoring of patients with these conditions [10]. Testing using the Fenom
Pro should only be done in a point-of-care healthcare setting under professional supervision. Fenom Pro is suitable for
children, approximately 7-17 years, and adults 18 years and older.
Clinical Limitations
Fenom Pro may not be used by children under the age of approximately 7 years, including infants, as measurement
requires patient cooperation. The determining factor for age limitation is based on a patient’s ability to understand
and execute the given instructions.
Fenom Pro should not be used in critical care, emergency care, or in anaesthesiology.
Elevated FeNO levels are also found in other inammatory conditions aside from asthma, such as allergic rhinitis [2],
systemic lupus erythematosus [3] and liver cirrhosis [4], and COPD including COPD overlap syndrome [5] [6].
Viral infections might lead to increased FeNO levels. The mechanism behind this increase is, however, separate from
the one causing the increased levels seen in allergic inammation. Virus related increases in FeNO may be resistant to
corticosteroid treatment [7].
Recent intake of nitrate rich food, including lettuce, spinach, beets, walnuts, peanuts, and animal organs, can lead to
increased FeNO levels [8].
Smoking reduces exhaled NO levels. However, FeNO can still dierentiate asthmatics from non-asthmatics among
smokers.
Risks to Health
There are no known direct risks to patient health posed by the use of Fenom Pro. However, failure to perform the test
as indicated or erroneous interpretation of results may lead to improper patient management.
Therefore, use of FeNO measurement results to adjust a treatment regimen without consideration of other clinical
factors could pose a risk.

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23
1
Fenom Pro Components
No. Description
1 Touch Screen
2 Handpiece
3Battery Indicator – Battery strength is below 25% if only one
bar is illuminated
4AC Power Indicator – Indicator is green when the device is
powered on and connected to an electrical outlet.
5 Power Button – Hold for one second to power on/o.
6 Single-Patient-Use Mouthpiece (accessory)
7 Carrying Handle
8 24 V Power Connection
Table 1: Fenom Pro Device Components
7
8
6
2

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Buttons Icon Name Description
Settings Button
Button used to open the Settings Menu. This menu allows for setting Time/
Date, selecting Language, viewing System Information, selecting Volume
Level, and Ordering Tests.
Test Licence
Status Button
(Tests available)
Button used to open Order Tests box. Green check mark indicates that the
device has tests available.
Test Licence
Status Button
(Few tests available)
Button used to open Order Tests box. Red exclamation point indicates a
few tests remain. Contact your distributor to order additional tests.
Display Buttons
There are several button icons that Fenom Pro utilises to help you easily navigate through the menu screens.
Table 2: Button and Indication Icons

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Chapter 2: Safety and Warnings
Safety Instructions
The following safety instructions apply in the handling and operation of Fenom Pro:
o Ensure the patient DOES NOT inhale through the device.
o Ensure the patient DOES NOT inhale through the mouthpiece.
o Ensure the patient DOES NOT exhale beyond the limits of their physical ability.
o Discontinue measurements if the breath manoeuvre is laborious for the patient.
o DO NOT allow use of Fenom Pro within 15 minutes after performing spirometry testing such as: FEV1, FEV6, FVC,
PEF, etc.
o DO NOT allow use of Fenom Pro within 60 minutes after exercising or smoking.
o Ensure the patient DOES NOT use the Fenom Pro without a new single-patient-use mouthpiece.
o Ensure the patient DOES NOT perform more than six breath attempts within one day.
o DO NOT allow use of Fenom Pro within 60 minutes after eating or drinking uids other than water.
Compliance
Fenom Pro is CE-marked according to the In Vitro Diagnostics Directive 98/79/EC.
Fenom Pro is RoHS compliant according to Directive 2011/65/EU Restriction of Hazardous Substances in Electrical and
Electronic Equipment.
Warnings
The following warnings apply in the handling and operation of Fenom Pro:
o Fenom Pro should only be operated by trained healthcare professionals.
o Operate Fenom Pro as stated in this manual. Spirosure accepts no responsibility for damaged equipment or faulty
results if the equipment is not handled according to this manual.
o DO NOT use a damaged Fenom Pro device, damaged components, or damaged accessories.
o Only use the provided power supply unit.
o Keep the device out of water. Ensure no liquid is spilled or dripped on the device.
o DO NOT use the Fenom Pro device adjacent to or stacked with other equipment because it may result in improper
operation.
o DO NOT block device vents and ports while in use or while charging.
o DO NOT drop the device or subject it to strong impact.
o DO NOT modify the Fenom Pro device, handpiece or mouthpiece.
o DO NOT use Fenom Pro in the proximity of areas where volatile substances such as organic uids or disinfectants
are being used. Special attention should be paid to aerosols and disinfection baths.
o DO NOT use Fenom Pro in the presence of ammable vapours or liquids.
o DO NOT use substances containing alcohol close to the Fenom Pro.
o The single-patient-use mouthpiece should be used immediately after opening.

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Electromagnetic Emissions
The emissions characteristics of this equipment make it suitable for use in hospitals and other healthcare settings
(CISPR 11 class A).
Electromagnetic Immunity
Fenom Pro has been tested to comply with the emission and immunity requirements described in IEC 60601-1-2:2007
General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests.
o DO NOT reuse the single-patient-use mouthpiece on other patients.
o DO NOT open, crush, incinerate, or heat the lithium-ion battery in the device above 140°F/60°C.
o DO NOT use the USB port to connect Fenom Pro to a computer.
o DO NOT touch the part of the mouthpiece that will go into the patient’s mouth. Either hold the mouthpiece using
the plastic packaging or wear latex gloves while attaching to the handpiece.
o A single-patient-use mouthpiece has a limit of three uses.

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Chapter 3: Fenom Pro Quick Start Guide
To perform a FeNO test, follow these three simple steps. For full test guidelines and instructions, see Chapters 4 and 5.
For set-up instructions, see Chapter 8.
NOTE: Check to make sure the device is powered on. If the device is on but the display is blank, touch the screen to
wake up the device. The device may take one minute to warm up.
2. Press the Begin Test button and instruct the patient
to inhale naturally to full capacity, place their mouth
on the mouthpiece ensuring a tight seal so that no air
escapes and exhale for the full breath test duration at a
steady ow.
1. Select the Adult or Child test on the screen display.
Remove a new single-patient-use mouthpiece from its
packaging and attach it to the hand-piece by pressing
the mouthpiece towards the top of the hand-piece and
twist clockwise to secure. Be careful to not touch the
part of the mouthpiece that will have patient contact.
Instruct the patient to keep the indicator over the star
at the top of the gauge.
Child test: Patients aged 11 and under.
Adult test: Patients aged 12 and up.
NOTE: See Chapter 7: Practise Mode if patient requires a
demonstration before taking the test.
NOTE: Having the indicator within the green range is
also acceptable.

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3. The Fenom Pro will display the Stop Now screen and
play an audible chime once the patient has successfully
completed the breath manoeuvre.
Results will display in 28 seconds.
If the patient has the Fenom Connect™ Asthma
Assistant installed on their mobile phone, allow the
patient to scan the QR Code displayed in the bottom
left corner.
(Contact your local representative for more information
regarding the Fenom Connect Asthma Assistant.)
Press the Done button and properly dispose of the
used mouthpiece.

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Chapter 4: FeNO Measurement Preparation
NOTE: See Chapter 2: Safety and Warnings for a list of safety instructions and warnings.
Pre-test Check
1. Check the battery indicator to ensure the unit has sucient battery power to perform a FeNO measurement.
If the battery indicator is below 25%, plug the device into the power supply before using.
2. Check that the device is on a at, stable surface while performing a FeNO measurement.
3. Conrm that the patient meets eligibility requirements:
o Age 7 and up.
o Has not consumed food or uids other than water in the preceding 60 minutes.
o Has not exercised or smoked in the preceding 60 minutes.
4. When the pre-test check is complete, proceed with Chapter 5: Perform FeNO Measurement.
Child test: Patients aged 11 and under.
Adult test: Patients aged 12 and up.
2. Fenom Pro provides two options at the warm-up
conclusion – begin Adult or Child test.
Wake up Device
1. If the device is powered o, press the Power button to
turn it on.
NOTE: If the device is powered on but the display is
blank, touch the screen to wake up the device.
Allow the device to warm-up for one minute.

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Chapter 5: Perform FeNO Measurement
The FeNO measurement is performed by the patient blowing into a single-patient-use mouthpiece that is attached to
a handpiece. The patient must blow into the mouthpiece at a controlled rate, which is monitored through an animated
graphic on the display. Once a sucient amount of the patient’s breath is captured, the sensor analyses the breath and
reports a FeNO score in parts per billion (ppb).
Perform an Adult FeNO Test
NOTE: Complete the steps in Chapter 4: FeNO Measurement Preparation before continuing with the steps below.
1. Lift the handpiece out of the cradle on top of the Fenom Pro.
2. Remove the new, single-patient-use mouthpiece from its packaging without touching the part that will go into the
patient’s mouth.
3. Attach the mouthpiece to the handpiece by rmly grasping the outer diameter of the mouthpiece and pushing
towards the top of the handpiece while twisting clockwise until secure.
4. Pass the handpiece to the patient with the mouthpiece attached.
5. Press the Adult button on the test selection screen.
6. Provide the patient with a brief overview on how to use the Fenom Pro device.
o Instruct the patient to inhale naturally to full capacity before placing their
mouth on the mouthpiece.
o Instruct the patient to place mouth on the mouthpiece and exhale for a full
10 seconds at a steady ow.
o Instruct the patient to keep their lips sealed around the mouthpiece so no
breath escapes from the patient’s lips.
NOTE: See Chapter 7: Practise Mode if patient requires a demonstration before
taking the test.
7. Press the Begin Test button when the patient understands the instructions and is ready to begin.
8. The visual incentive gauge is displayed.
9. Instruct the patient to begin exhaling into the mouthpiece whenever ready.
10. Ensure that the patient stops exhaling once the Stop Now screen is displayed.
11. If the patient was unsuccessful in performing a breath manoeuvre, review the reason for the failure. If necessary,
the patient can attempt a test in Practise Mode (Chapter 7) before repeating.
12. Proceed to instructions in the View Results section of this Chapter.

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Perform a Child FeNO Test
NOTE: Complete the steps in Chapter 4: FeNO Measurement Preparation before continuing with the steps below.
1. Lift the handpiece out of the cradle on top of the Fenom Pro.
2. Remove the new, single-patient-use mouthpiece from its packaging without touching the part that will go into the
patient’s mouth.
3. Attach the mouthpiece to the handpiece by rmly grasping the outer diameter of the mouthpiece and pushing
towards the top of the handpiece while twisting clockwise until secure.
4. Pass the handpiece to the patient with the mouthpiece attached.
5. Press the Child button on the test selection screen after powering the Fenom
Pro device on.
6. Provide the patient with a brief overview on how to use the Fenom Pro device.
o Instruct the patient to inhale naturally to full capacity before placing their
mouth on the mouthpiece.
o Instruct the patient to place mouth on the mouthpiece and exhale for a full
6 seconds at a steady ow.
o Instruct the patient to keep their lips sealed around the mouthpiece so no
breath escapes from the patient’s lips.
NOTE: See Chapter 7: Practise Mode if patient requires a demonstration before
taking the test.
7. Press the Begin Test button when the patient understands the instructions and is ready to begin.
8. The visual incentive gauge is displayed.
9. Instruct the patient to begin exhaling into the mouthpiece whenever ready.
10. Ensure that the patient stops exhaling once the Stop Now screen is displayed.
11. If the patient was unsuccessful in performing a breath manoeuvre, review the reason for the failure. If necessary,
the patient can attempt a test in Practise Mode (Chapter 7) before repeating.
12. After successful completion of the test, proceed to the View Results section of this Chapter.

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View Results
Upon completion of the FeNO test, the patient’s breath
is analysed, and the results are displayed in ppb. It takes
approximately 28 seconds for the results to be displayed.
1. View the FeNO result.
2. If the patient has the Fenom Connect Asthma Assistant
installed on their device, instruct the patient to open
their app and scan the present QR Code for their test
results.
3. Touch the Done button.
Remove Mouthpiece
When the patient has completed performing a FeNO measurement:
1. Remove the mouthpiece by rmly grasping around the outer diameter and twist counter-clockwise while pulling
away from the handpiece.
2. Properly dispose of the used mouthpiece.
3. Replace the handpiece in its cradle on top of the device.

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Chapter 6: Power O Device
It is OK to leave the device powered-on at all times. Your device will automatically go into sleep mode when not being
used. Only power o if you don’t intend to use for extended periods of time.
To power o the device:
1. Hold the POWER button down for at least 1 second.
2. Press OK on the conrmation window.
NOTE: It is recommended to keep the Fenom Pro device connected to a power supply whenever possible.
Chapter 7: Practise Mode
The Practise mode is used for a new patient in order to demonstrate the steps for performing a FeNO test. Results are
not recorded in this mode.
IMPORTANT!
Using the Practise mode counts as one exhalation toward the maximum six exhalations
per patient per day and toward the maximum three exhalations per mouthpiece.
To access the Practise mode:
1. On the main selection screen, select the appropriate test for the patient based on their age.
o Patients aged 11 and under will proceed with the Child option.
o Patients aged 12 and up will proceed with the Adult option.
2. Press the Practise button.
3. Attach a new, single-patient-use mouthpiece to the handpiece and review how to use the Fenom Pro device with
the patient. (See Chapter 5: Perform FeNO Measurement for detailed instructions.)
4. The patient inhales then begins exhaling into the mouthpiece when ready.
o Child tests require the patient to exhale for 6 seconds.
o Adult tests require the patient to exhale for 10 seconds.
5. The patient stops exhaling once the countdown reaches 0 (zero).
6. If training was successful, Good job! is displayed.
7. If training was unsuccessful, Try again is displayed.
8. Press the Repeat arrow to perform training again and go back to Step 4, or press Done if nished to go back to the
main login screen.

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Chapter 8: Device Set-up
Initial Set-up
To set up the Fenom Pro device:
1. Remove the device and power cable from the shipping package.
NOTE: Retain all packaging for future transportation of the device.
2. Connect the breath tube to the orange port at the bottom of the handpiece. Ensure the breath tube is fully seated
against the rear surface, as shown in the gure. The second gure shows an improper breath tube connection.
3. Once the breath tube is connected, place the handpiece in the cradle on top of the device.
4. Connect the power cable from the rear panel of the device to an outlet.
(See Table 1 for power connection location.)
The AC Power Indicator displays green when the device is plugged in and powered on.
NOTE: The device should be allowed to charge for at least 4 hours before operating on battery power. The device
can operate normally while charging.
5. Press the Power button to turn on the device.
6. The Device Set-up screen will be displayed after powering on. From this screen, set the following device settings:
o Select Language
o Set Time/Date
o Add Tests
These settings can be accessed and changed at any time.
7. The Fenom Pro is now ready to begin a test.
Correct Incorrect

IFU-3264 Rev B Instructions for Use, Fenom Pro
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Language
1. Press Language on the Settings screen.
2. Select the desired language.
3. A check mark next to the language indicates the
selected language.
Conguration Settings
There are device settings that require conguring based on location and requirements. These settings are accessed
through the Settings icon. (See Table 2: Indicators and Icons.)
Time/Date
1. Press Time/Date on the Settings screen to set the date
and time on the device.
2. Use the + and - buttons to set the date and time.
3. Press the AM/PM button to toggle between values.
4. Press the Time Zone drop-down list and select the
correct time zone.
Device Settings
1. The Settings button provides access to set the Time
and Date, select Language, view System Info, select Test
Incentive Sound level, and Add Tests.

IFU-3264 Rev B Instructions for Use, Fenom Pro 19
Add Tests
1. Contact your distributor representative and ask for
additional licensed tests for the Fenom Pro.
2. Enter the code provided by the distributor
representative and press Add Tests.
Test Incentive Sound
1. Press Test Incentive Sound on the Settings screen to set
the desired volume level, High, Low, or O.
2. A check mark indicates the current selection.
System Information
1. Press System Info on the Settings screen to view Device
Serial Number, Licensed Tests (number of licensed tests
remaining), Service Due Date, Software Version, and
Firmware Version.