inofab SPIROHOME User manual

SPIROHOME® FDA DOSSIER
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SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME®
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SPIROHOME®
ULTRASONIC SPIROMETER
The document will be signed after revision.
FUNCTION
DATED
SIGNED
Prepared by
Regulatory Affairs
Deniz SARP
Reviewed by
Quality Assurance
Ahmet Gökdere
Approved by
CEO
Merthan Öztürk
REVISION RECORD
REVISION
NUMBER
DATE
COMMENTS
SIGNED
00
24.02.2019
Initial Issue
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SPIROHOME® FDA DOSSIER
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USER MANUAL - PERSONAL
SPIROHOME®
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Spirohome® Personal
User Manual
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1.Preface
1.1 Spirohome® Personal user manual version history
Version Number
Publication Date
Description
Rev.00
24.02.2019
Initial version for market launch
This revision of the Spirohome®Personal user manual applies to Spirohome®Personal devices
with a serial number between S011900001-S011900150.
Version histories of all Spirohome®user manuals can be found on the Spirohome®website
www.spirohome.io.
For any queries relating to the revision history of the user manual or product, please contact
your Spirohome® dealer or manufacturer.
1.2 Intended use of the Spirohome® Personal
The Spirohome®Personal is a prescription device for diagnostic spirometry testing of adult and
pediatric patients over the age of 5 who have been diagnosed with a chronic pulmonary disease
including, but not limited to, asthma, chronic obstructive pulmonary disease and cystic fibrosis. It
is to be operated in the home setting by competent adult patients or caregivers of
patients.
1.3 About this user manual
This user manual should be read by users of the device prior to operating the Spirohome®
Personal. Store this user manual in a clean and easily accessible place for future reference.
1.4 Legal Information
Contents of the user manual may be subject to change. Please refer to the Spirohome®website
for the latest version of user manuals. No part of this manual may be reproduced without the
written permission from Inofab.
© İnofab Sağlık Teknolojileri A.Ş, Ankara, Turkey. All rights reserved.
Spirohome® is a registered trademarks of İnofab Sağlık Teknolojileri A.Ş.
Spiroway® s a registered trademarks of İnofab Sağlık Teknolojileri A.Ş.
Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
1.5 Electromagnetic Compatibility
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SPIROHOME® FDA DOSSIER
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USER MANUAL - PERSONAL
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This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Changes or modifications made to this equipment not expressly approved by Inofab Sağlık
Teknolojileri A.Ş. may void the FCC authorization to operate this equipment.
1.6 Product Disposal
This product should not be discarded as regular household waste but as electronic waste
according to in accordance with local regulations and returned to a collection point of recycling
electric and electronic devices.
Used batteries should be disposed of in designated battery recycling containers in accordance
with local laws and regulations
1.7 Manufacturer Information
İnofab Sağlık Teknolojileri A.Ş
ODTÜ Teknokent Silikon Blok
K:1 NO:15-A Ankara/Turkey
Tel: +90 312 988 0308
www.spirohome.io
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SPIROHOME® FDA DOSSIER
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Table of Contents
1. Preface
1.1 Spirohome® Personal user manual version history
1.2 Intended use of the Spirohome® Personal
1.3 About this user manual
1.4 Legal Information
1.5 Electromagnetic interference
1.6 Product disposal
1.7 Manufacturer Information
2. Safety Information
2.1 Safety warnings and precautions
2.2 Restrictions on use and contraindications
2.2 Signs and symbols
3. About the Spirohome® Personal
3.1 Product description
3.2 The Spirohome® Personal System
3.3 Orderable accessories
4. Cybersecurity
4.1 About cybersecurity and your Spirohome® Personal
4.2 Passwords on the Spirohome® Personal platform
4.3 Software Updates
4.4 Data back-ups
4.5 Security breaches
4.6 Lost or stolen devices
5. Spirohome® Personal and smart device connectivity
5.1 Connectivity of the Spirohome® Personal platform
6. Operating the device
6.1 How to use the Spirohome® Personal: An overview
6.1 Operating environment
6.2 Setting up your Spirohome® Personal
6.3 Device indicators
6.4 Technical features of the Spirohome® Personal
6.5 Troubleshooting and error messages
7. Spirometry with your Spirohome® Personal
7.1 How to perform a spirometry test
7.2 Spirometry parameters
7.3 Types of breathing maneuvers
7.4 Understanding test quality
8. Maintenance and Cleaning of your Spirohome® Personal
8.1 Cleaning and disinfection of the device
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8.2 Cleaning of the Spiroway® mouthpiece
8.3 Replacing batteries
9. Terms of warranty
9.1 Terms of warranty for the Spirohome® Personal
10. Appendix
8.1 Electromagnetic compatibility
2. Safety Information
2.1 Safety warnings and precautions
Important! Please adhere to the recommendations, warnings and guidelines set out in
this user manual as failure to comply may result in measurement errors, display of
incorrect results or harm to the user.
General:
The manufacturer is not responsible for any damage/harm to either the device or user which
has resulted from nonadherence to the warnings, precautions and instructions given in the
official device user manual, labeling and other informational material.
In the occurrence of any adverse events, report immediately to your doctor and/or authorities as
required by local legislation. The user must also report such incidents to the manufacturer.
Product and components:
Do not use the device if there is any damage is present on the device or its components upon
removal from packaging, and return the product to the supplier.
The Spirohome®Personal must only be used with the original accessories specified and
provided by the manufacturer. Use of unspecified mouthpieces may cause inaccurate test
readings, or damage/harm to the user and/or device. Do cause damage to or use the
mouthpieces with physically compromised filters.
Do not expose the device to liquids, prevent any liquids from entering the device. In the event of
a liquid spill on or around your Spirohome®Personal, immediately remove the batteries and let
the device dry thoroughly before use.
Data:
Only a qualified healthcare professional can make a diagnosis with, in addition to other medical
testing and your clinical history, the data presented by the Spirohome® Personal.
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Please ensure that your personal data such as height, weight, age, sex and ethnicity are
entered according to your current state and that the values are entered correctly.
Regardless of the data presented on the Spirohome®Personal, if you feel unwell or have
respiratory illness symptoms please contact your healthcare provider immediately.
Please follow all data security warnings and recommendations for your personal smart device
as per its manufacturer’s instructions as your personal data, which will include that recorded and
stored on the Spirohome®App, may otherwise be at risk. The user is encouraged to not share
their Spirohome® app account information with unauthorized parties.
If your Spirohome®Personal is damaged or malfunctioning or you encounter data that you
cannot make sense of, contact the manufacturer directly and cease use.
Users:
Do not use your Spirohome®Personal for any other purpose than its intended use. Spirohome®
Personal is not recommended for children under the age of 5.
Do not share your Spirohome®Personal with any other users, including family members, as the
Spirohome®Personal and Spiroway®reusable mouthpiece is to be used by a single user only. If
a new user is to use the device, ensure that the device is cleaned and disinfected (see
Maintenance section of this manual), a new mouthpiece is used and a new account is created
for the user on the app.
For patients who require assistance by competent caregivers, special warnings regarding the
Spirohome®Personal should be provided by the caregiver to the patient prior to using the
device.
Testing:
One ‘use’ of the spirometer is defined as one complete spirometric testing session (can include
up to 8 individual successive spirometry tests). The mouthpiece should be fully inserted before
and during a test. Start test again if mouthpiece dislodges during testing.
You MUST use a mouthpiece during testing. Blowing into the device directly will cause incorrect
measurements and potential harm to both the user and device.
Make sure the base of the device lumen is clear of fingers or any other materials that may be
blocking this exit as measurement by the device may be affected.
Do not walk or run while taking a lung function measurement using Spirohome®spirometer. Do
not perform a spirometry test with food or objects in oral cavity to avoid risk of choking.
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Pulmonary function tests require maximum effort on the part of the patient and may lead to
sensations of dizziness or giddiness. Do not perform more than 8 spirometry tests in one
spirometry session. If you sense dizziness while performing a test, stop the test immediately and
rest.
Environment and storage:
Store and use the device as specified in this user manual as alternative methods or conditions
of storage may affect device function and/or accuracy. Use only in specified
environments/conditions (see Operating Environment section of this user manual) to avoid
malfunction and/or display of incorrect results.
Store the Spirohome®Personal in dust/dirt and moisture free conditions. You may utilize the
pouch provided with the device to keep the device protected. Before each use, always check
that the device is free from contaminants and does not have any visible damage.
To prevent damage to the Spirohome®Personal due to battery leakage or oxidation, remove all
batteries if the Spirometry module is not to be used or is to be stored for a long period of time.
The Spirohome®Personal should never be used with a charging smart device. Make sure the
smart device is unplugged from its charger before conducting a spirometry test.
Maintenance:
The user should periodically check to ensure that foreign bodies or impurities are not present on
visible and accessible areas of the device as this could lead to inaccuracies in test
measurements. Coughing or spitting into the device may cause incorrect readings.
All repairs, modifications or reconfigurations must be performed only by the manufacturer, an
opened device casing will terminate product warranty.
2.2 Restrictions on use and contraindications
Spirohome®Personal must only be used by a single user  . If the device will be passed on to a
new user, ensure that the personal data of the previous user is erased from device memory and
the personal data of the new user is entered into the system prior to conducting any tests.
Do NOT share the Spiroway®reusable mouthpiece, including with family members. Any new
user of the device must use a new Spiroway® reusable mouthpiece.
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The spirometry tests should only be performed by users who do not experience any shortness
of breath and are in good health for performing a lung function test. Test results of patients who
do not meet these conditions may not be reliable.
Failure to perform the specific breathing maneuver of a particular spirometry test correctly may
lead to inaccurate and/or unacceptable results. Refer to the Breathing Maneuvers section of this
user manual for more information.
Some medical conditions may pose a danger to you or affect the validity of spirometry
performance and results. These conditions include, but are not limited to, the following: acute
disorders (e.g. active lung infection), illness or condition that may cause serious consequences
if aggravated by forced expiration (e.g. dissecting / unstable aortic aneurysm, recent/current
pneumothorax, recent surgery including ophthalmic, thoracic, abdominal or cerebral aneurysms,
unstable angina), recent myocardial infarction (within one month), recent pulmonary embolism,
undiagnosed chest conditions (e.g. haemoptysis of unknown origin), nausea, vomiting, severe
respiratory distress, physical limitations or cognitive impairment or dementia. If you have or
suspect having any of the conditions above, consult your healthcare professional before
using the  Spirohome® Personal.
2.2 Signs and symbols
Please note the following signs and symbols provided for the safe use and storage of your
Spirohome® Personal.
Markings
Descriptions
“Manufacturer”
The name and the address of the manufacturer is adjacent to the symbol.
‘FCC ID’
Unique identifier given by the Federal Communications Commission
‘Rx Only’
Prescription-only device
Disposal in compliance with Waste Electrical and Electronic Equipment Directive
Temperature limit
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Humidity limit
Atmospheric pressure limit
Do not use if package is damaged
Keep away from sunlight
Keep dry
Single use only
Type BF of Medical Electrical Equipment
SN
Serial Number
Lot Number
Ref Number
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IP
IP Number
Device includes RF transmitters
The instruction manual/booklet must be read.
3. About the Spirohome® Personal
3.1 Product description
The Spirohome®Personal is a portable spirometer that pairs (via Bluetooth®) to smart devices
running with iOS or Android. The Spirohome®Personal measures and displays certain
parameters of lung function of the user. The user performs a spirometry test as described in the
How to perform a lung function test section of this user manual. Briefly, as the user exhales into
the device through its mouthpiece, internal ultrasonic sensors detect the volume and speed of
the expired air, the device converts this information into spirometric data and displays it via the
Spirohome®application on a connected smart device. The Spirohome®app prompts and guides
the user throughout the test for accurate data collection and display. The Spirohome®app can
be downloaded on GooglePlay or on Apple’s App Store. The device is powered by 2 x AAA
Alkaline batteries. Spirohome® Personal works with the Spiroway® reusable mouthpiece.
3.2 The Spirohome® Personal System
Your Spirohome® Personal System consists of:
· Spirohome® Personal (b)
· Spiroway® reusable mouthpiece(a)
·Spirohome® Personal cap(c)
· 2 x AAA Batteries
· User manual
· Quick start guide
· Carrying pouch(d)
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Caution!: Please check to ensure that there is no visible damage on any of the components of
the Spirohome®Personal. If damage is present, do not use or attempt to repair the device,
please contact the manufacturer directly.
Connected smart device requirements:
Spirohome®Personal with iOS device: Requires İOS 11.0 or later. Compatible with Iphone 5s or
later, iPad Air Wifi or later, and Ipod touch.
Spirohome® Personal with Android device: Requires Android API level 21 (Lollipop 5.0) or later.
3.3 Orderable accessories
You can order new or replacement Spirohome® Personal accessories from www.spirohome.io.
When placing your order, please be sure to note the accessory reference number.
Accessory Name
Reference Number
Spiroway® Reusable Mouthpiece
03000
Spiroway® Disposable Mouthpiece
04000
Spirohome® Personal Cap
01104
Spirohome® Pouch
01509
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4. Cybersecurity
To protect your device and data, please read and apply the following guidance.
4.1 About cybersecurity and your Spirohome® Personal
The Spirohome®Personal platform involves the connection of your Spirohome®Personal device
to the Spirohome®Personal app. The data you enter and record with your Spirohome®Personal
device via the Spirohome® Personal app is stored on a SQL-server database.
Spirohome®Personal automatically connects to the network. It will still work off-line, and transfer
data to the network as soon as a connection is established. Both the local database (connected
smart device) and server-based database (Spirohome® database on the network) is encrypted.
4.2 Passwords on the Spirohome® Personal platform
Access to your Spirohome®Personal device is granted through the entry of a username and
password which you will create at first set-up of the device and app. It is the responsibility of the
user to change or update password information at regular intervals (every 3 months) for
ensuring security. Please choose a password that is strong and difficult to be copied by
unauthorized users. The minimum requirements for a Spirohome®password is using at least 8
characters, at least one uppercase and one lower case alphabetic characters and at least one
number.
4.3 Software Updates
In order to improve the Spirohome®app features or incorporate new security features,
Spirohome®software updates may be sent to your smart device. Your device will be sent
notifications about installing the latest update to the app. If warning notifications for software
updates are ignored, access to testing on the app may be barred until the update has been
installed. This is to ensure that important improvements to app features and security have been
updated for your safety.
4.4 Data back-ups
Any data that is stored on Spirohome®servers are periodically backed-up. Spirohome®devices
must be connected to a network to allow for data on the device to be transferred, stored and
regularly backed-up on Spirohome®servers. For any data that is stored on personal servers or
smart devices, it is the responsibility of the user to back this data up.
4.5 Security breaches
1. Change password, password is checked every time you log in. Changing password on
one connected device will log you out of all connected devices.
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2. If your password has been breached, try resetting your password through your
registered email address by clicking ‘Forgot Password’.
3. Contact manufacturer
4.6 Lost or stolen devices
If your Spirohome® Personal device is lost or stolen, please report the issue immediately and
directly to you Spirohome® Personal provider. Your provider will ensure that your device is
locked for use by any unauthorized users.
Your device is paired to your user account. A device cannot be designated to two different user
accounts.
5. Spirohome® Personal and smart device connectivity
5.1 Connectivity of the Spirohome® Personal platform
The Spirohome®platform allows a range of devices to connect to a central network. Several
smart devices with the Spirohome®Personal app can connect to and share information on a
central database. Access to a patient’s information from different devices requires that the same
user account information is entered on all devices.
6. Operating the device
6.1 How to use the Spirohome® Personal: An overview
6.2 Operating environment
The Spirohome®Personal is designed for use in a home setting. It should not be used in a
clinical setting such as a hospital or private clinic.
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.
The operating conditions  for the Spirohome® Personal is specified as:
Temperature: 15°C to +40°C
Relative Humidity: 5% to 95%
The storage conditions  for the Spirohome® Personal is specified as:
Temperature: -20°C to +50°C
Relative Humidity: 5% to 95%
Pressure: 500 hPa to 1060 hPa
The Spirohome®Personal should not be used in the presence of inflammable liquids or
detergents, nor in the presence of inflammable anaesthetic gases (oxygen or nitrogen).
The device should not be used in direct air currents (e.g. wind), sources of heat or cold, direct
sun rays or other sources of light or energy, dust, sand or any other chemical substances.
The instrument may give inaccurate readings if operated in the presence of strong
electromagnetic sources, such as electrosurgical equipment, or in the presence of computed
tomography (CT) equipment.
The Spirohome®Personal conforms to EN 60601-1, EN 60601-1-11, EN 60601-1-2 and EN 300
328. As this device operates with RF technology, it must be only as specified by the
manufacturer, it may to avoid interference to radio communications.
6.3 Setting up your Spirohome® Personal
1.Download the Spirohome® Personal app
from the App Store or Google Play Store onto
your smart device.
2. Follow the steps given on the app screen
to create a new user account or log in to your
existing account.
3. Pull out the battery protector (1) and press
the power button (2) for one second to switch
4. Enable Bluetooth® on your smart device,
and select your Spirohome® Personal from
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on the device.
available devices. Your device should now be
paired.
6.4 Device indicators
There are 3 LED lights located on the front of the device. The following picture shows the
assigned numbers to each LED.
The LED lights may be turned on or flashing various colors and/or in various patterns. The LED
lights indicate the current status of the device. Please see the following information for guidance
on LED light indications.
LED Display
Indication/s
None of the LEDs are on
The device is switched off
LED indicators are consecutively flashing
green
The device is switching on
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LED number 3 is constantly flashing green
The device is switched on
LED number 2 is fading blue
The device is connected to the app. Bluetooth®
connection has been established.
LED number 2 and LEDs 1 and 3 together
are flashing in turn.
The baseline is setting up.
LED number 1 is constantly blue.
The device is ready for a test.
During a test, LED number 1 is constantly
yellow.
The test has timed-out (there has been no
inhalation/exhalation over a period of time)
During baseline setup LED umber 1 is
constantly yellow.
The baseline setup has been unsuccessful.
All LEDs are flashing red.
There is a foreign object between the sensors.
(TOF out of range error)
LEDs are consecutively flashing yellow.
Over-the-air connection is being established.
LED number 3 flashes red three times.
Battery low warning.
LEDs flash in reverse order and remain
switched off.
The device is switching off.
6.5 Technical features of the Spirohome® Personal
Flow / Volume measurement method
Ultrasonic Transducer Measurement
Power Supply
2 x 1.5V AAA batteries
Dimensions
110 x 63 x 41 mm
Weight (With batteries)
90 g
Weight (Without batteries)
67 g
Flow range
0 - 14 L/s
Maximum volume measured
10 L
FVC accuracy (Average)
± 2 %
FEV1 accuracy (Average)
± 2 %
PEF accuracy (Average)
± 1.9 %
Dynamic resistance at 14 L/s
68.2 Pa*s/L
Volume resolution
1 mL
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Flow resolution
1 mL/s
Medical device class
Class IIA
Wireless connection
BLE 4.2
6.6 Troubleshooting and error messages
Problem
Cause
Solution
Device Not turning on
Multiple possible causes
Check battery orientation and
correct polarities!
Remove the AAA batteries
and wait 30 seconds and
reinstall AAA batteries
Replace AAA batteries
Check that the battery cap is
in the lock position, or if cap
is broken, contact
manufacturer
Spirohome® cannot connect
to a smart device via
Bluetooth®
Smart device is out of range
Bring your smart device
closer to the Spirohome®
device
Smart device Bluetooth® is
disabled
Enable Bluetooth® of your
smart device
Bluetooth® connection not
working properly
Your smart device will need
Bluetooth® version 4.0 or
higher. Find and select
Spirohome® Personal from
list of detected devices.
Test results are inconsistent
Spiroway® mouthpiece is dirty
Clean Spiroway® mouthpiece
to ensure that the lumen is
not obstructed or replace
with a new mouthpiece
Spiroway® mouthpiece is
damaged
Replace Spiroway®
mouthpiece
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Spirometry test was
performed incorrectly
Refer to How to Perform a
Lung Function Test in user
manual or refer video tutorial
on app
Spiroway® mouthpiece is
installed incorrectly
Refer to the user manual for
proper installation of
Spiroway® mouthpiece
Test does not start - Cannot
set up baseline
Direct air current in
environment
Close the cap of the
Spirohome® to avoid effects
of environmental flow
Place device on a flat surface
Remove causes of direct air
current e.g. air conditioner,
opened window, fan, etc.
Test does not start -
animated balloon is not
moving
Multiple possible causes
Quit test and start new test
Quit application and start a
new test
Switch device on and off
again to reset
Test Starts before you start
blowing
Vigorous handling of the
device
Keep device as stable as
possible after starting a test
Test does not end and keeps
going
Inhalation at the end of test
not performed
After a forced exhalation,
take a short breath through
the spirometer before
breaking the seal of your lips
around the mouthpiece. The
device ends the
measurement when it detects
a small amount of negative
volume
Error Messages
Message
Possible Cause
Solution
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Error 01
Bluetooth® is disabled
Enable Bluetooth® on your smart device from its
settings menu
Error 02
Batteries of the Spirohome®
Personal need to be
replaced
Replace batteries as described in the
Maintenance section of this user manual
Error 03
Components not attached
correctly.
Ensure that the mouthpiece is attached to your
Spirohome® Personal device correctly
Sensors are obstructed.
Ensure that the components are clean and clear
of foreign body materials.
Test was not performed
correctly.
Repeat the test following the rules and
conditions specified in the Performing a Lung
Function Test section of this user manual.
Error 04
Flow measurement limit is
exceeded
Consult the manufacturer or healthcare provider
Error 05
Sensor Error
Consult Manufacturer
Error 06
Device disconnected during
test
Relaunch app and start test again
Error 07
Self sensors test failed
Check lumen of device to ensure that sensors
are not obstructed
Contact Manufacturer
Error 08
Poor or no internet
connection
Check to ensure that smart device is connected
to the internet
For any other technical queries please call our customer service on [phone]
7. Spirometry with your Spirohome® Personal
7.1 How to perform a spirometry test
There are several types of tests and different parameter relating to lung function that can be
involved in a spirometry test. Each type of spirometry test requires a specific breathing
maneuver in order to detect the parameters related to that particular test type. However, the
general method of performing a spirometry test remains the same for all test types. Please keep
reading for more information about test types, test parameters, breathing maneuvers and
understanding the quality of test results.
Note: One spirometry session refers to a full set of spirometry tests performed in one sitting. The
recommended number of tests per spirometry session is 3, however, you may perform up to 8
tests. The best values obtained from the spirometry tests performed in one session is displayed
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