Cohero Health mSpirometer User manual

LBL-IFU-000091 Rev.B
Issue Date: 7.2018
mSpirometer™
Lung Function
Sensor
User Manual
Before you use your mSpirometer sensor,
please read this user manual, the labels and
all the information with the product.
0476

© Cohero Health, Inc 2018
TABLE OF CONTENTS
1. INTRODUCTION..................................................................................................................
1.1 Intended use..........................................................................................................................................
1.1.1 Usage environment......................................................................................................................
1.1.2 Restrictions on Use......................................................................................................................
1.2 Description of product........................................................................................................................
1.3 Parameters measured by mSpirometer sensor...........................................................................
1.4 Determining your baseline values....................................................................................................
2. OPERATING THE mSPIROMETER SENSOR.........................................................................
2.1 Inserting the batteries.........................................................................................................................
2.2 Installing the BreatheSmart®application........................................................................................
2.3 Connection between mSpirometer sensor and smartphone....................................................
2.4 Performing the test..............................................................................................................................
2.4.1 Evaluating the test........................................................................................................................
2.4.2 Results diary...................................................................................................................................
2.5 Important safety warnings..................................................................................................................
2.6 Data security warnings.......................................................................................................................
2.7 Warning for use in electromagnetic environment.......................................................................
2.8 Notes on FCC certification.................................................................................................................
3. CARE AND CLEANING .......................................................................................................
3.1 Cleaning and disinfecting of the turbine.......................................................................................
3.2 Cleaning and disinfecting of the mouthpiece..............................................................................
3.3 Cleaning of the device........................................................................................................................
3.4 Replacing batteries..............................................................................................................................
4. ERROR MESSAGES & TROUBLESHOOTING.......................................................................
4.1 Error messages.....................................................................................................................................
4.2 Troubleshooting...................................................................................................................................
5. ACCURACY AND RELIABILITY............................................................................................
6. LABELS & SYMBOLS...........................................................................................................
7. TECHNICAL SPECIFICATIONS............................................................................................
8. BLUETOOTH WIRELESS TECHNOLOGY INFORMATION..................................................
9. INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT.........
10. WARRANTY TERMS ........................................................................................................
2
mSpirometer™ sensor
4
4
4
4
5
5
6
7
7
7
7
8
10
10
10
11
12
12
13
13
14
15
15
16
16
17
18
19
20
21
24
28

© Cohero Health, Inc 2018
3
Thank you for choosing a Cohero Health product.
Before you use your mSpirometer sensor, please read this user manual, the labels and all the
information provided with the product.
Before connecting mSpirometer sensor to a smartphone, install the BreatheSmart application developed
to show data measured by the device.
The package includes:
• The mSpirometer sensor
• The turbine sensor
• The plastic mouthpiece
• 2 AAA batteries
• The User Manual
• The Quickstart Guide with BS installation instructions
After removing the device from its packaging, check that there is no visible damage. If there is, do not use
the device and send it back to Cohero Health for replacement.
Keep the original packaging!
If your product has a problem, use the original packaging to ship it back to Cohero Health.
If you have any problems, contact:
Cohero Health
12 E. 49th St.
New York, NY 10017
Website: www.coherohealth.com
Email: [email protected]
Cohero Health cannot be held responsible for any damage caused by users failing to
follow these instructions and/or the warnings contained in this manual.
mSpirometer™ sensor

© Cohero Health, Inc 2018
4
1. INTRODUCTION
1.1 Intended use
mSpirometer sensor is intended to be used either by a physician or by a patient under the instruction
of a healthcare provider. The device is intended to test lung function and can perform spirometry testing
in people of all ages, excluding infants and neonates.
mSpirometer sensor is indicated for monitoring asthma, COPD and other respiratory diseases.
1.1.1 Usage environment
mSpirometer sensor can be used in a factory, hospital, doctor's office, workplace, or home.
1.1.2 Restrictions on Use
Analysis of the test results alone are not sufficient to diagnose your clinical condition.
Diagnosis requires a medical examination or evaluation, including clinical history, and possibly
other tests recommended by a healthcare professional.
Diagnosis and appropriate treatments are to be given only by a qualified healthcare professional.
If you wish to use the device when it has already been used by another person, be sure to disinfect
the mouthpiece and turbine, as explained in the Maintenance section.
mSpirometer™ sensor

© Cohero Health, Inc 2018
5
1.2 Description of product
mSpirometer sensor is a pocket-sized system for measuring the following respiratory parameters:
•PEF (Peak Expiratory Flow)
•FEV1(Forced Expiratory Volume in 1 sec)
The following parameters are only available with a full spirometry test:
• FVC (Forced Vital Capacity)
• FEV1/FVC ratio
Certain configurations of the BreatheSmart application may only calculate PEF and FEV1.
The device connects to a smartphone via Bluetooth SMART technology. Connection is
automatic once the BreatheSmart application has been installed on the smartphone.
Measurement is performed by a turbine sensor, and using infrared technology to ensure
accuracy and reproducibility.
This type of sensor is:
•Unaffected by humidity and density of gas
•Shockproof
•Inexpensive to replace
•FEV6(Forced Expiratory Volume in 6 sec)
•FEF25-75 (Average Forced Expiratory Flow at 25%-75%)
mSpirometer™ sensor
1.3 Information on the parameters measured by mSpirometer sensor
PEF is the maximum flow rate of air exhaled forcefully from a position of full inspiration.
FEV1 is the volume of air expelled during the first second of the same exhalation. FVC is the volume of air
expelled during the total exhalation.
FEV1/FVC is a ratio that represents how much air you can blow out forcefully in one second over the total
amount of air you can exhale over 6 or more seconds.
FEV6 is the volume of air expelled during the first six seconds of exhalation.
FEF25-75 is the average of the flow at the middle portion (25%-75%) of a forced exhalation.
For each of these parameters, the result is a number shown on the smartphone screen.

© Cohero Health, Inc 2018
A higher number usually means that the air is moving easily through your airways. If you have asthma
(or another respiratory disease) there may be obstruction to expiratory airflow, so your numbers may
be reduced.
mSpirometer sensor thus helps you assess the health of your lungs, at any particular time. By using the
device on a regular basis, you can track changes that may occur in the parameters. These changes, along
with changes in how you feel, may require treatment, as prescribed by your healthcare provider.
It is recommended that you use the device twice a day, in the morning on waking and at bedtime.
The device should also be used at the first sign of respiratory problems.
In addition to displaying the PEF, FEV1, FVC, FEV1/FVC ratio, FEV6or FEF25-75 measurement, the device also
provides a normal baseline value. The value is normally called the personal best value. Please refer
to the section DETERMINING YOUR BASELINE VALUE for a clear understanding of the baseline value.
1.4 Determining your baseline value
Your healthcare provider can help to determine what values to expect when your respiratory condition
is optimal.
Your healthcare provider may use one of two possible ways to identify your baseline value.
The first method adopts the predicted value calculated according to the results of epidemiological studies
of large groups of healthy subjects of your same age, height, sex, and origin. The second method adopts
the personal best value you can achieve when your breathing is best. Once your baseline values are
established, future measures are compared to these values. Your healthcare provider can then assess,
along with details about your symptoms, how well you are doing on your current treatments and whether
any changes in treatment regimen are recommended.
mSpirometer™ sensor
6

7
© Cohero Health, Inc 2018
2. OPERATING THE mSPIROMETER SENSOR
2.1 Inserting the batteries
Follow the instructions in the Maintenance section for correct battery insertion.
2.2 Installing the BreatheSmart application
Before measuring the PEF, FEV1, FVC, FEV1/FVC, FEV6or FEF25-75 you need to install application
on your smartphone.
The BreatheSmart app can be downloaded at the App Store or Google Play.
2.3 Connection between mSpirometer sensor and smartphone
Connection between the mSpirometer sensor and the smartphone is wireless. To check
whether there is a connection, read the messages from the application.
mSpirometer™ sensor

8
© Cohero Health, Inc 2018
2.4 Performing the test
In order to perform the test properly, please follow the instructions below.
Push the turbine into the
slot until it stops
Turn the turbine clockwise
until it stops
Insert the mouthpiece at
least 0.5 cm into the
turbine socket.
Pick up the mSpirometer sensor
with your hand as if it were
a cell phone.
Make sure not to
obstruct the turbine
with your hand.
1 2
34
mSpirometer™ sensor

9
© Cohero Health, Inc 2018
Insert the mouthpiece into your mouth past your teeth and close your lips tightly over it
so that the air you breathe will pass only through the mouthpiece.
To prevent turbulence that might otherwise affect the results, do not put your
tongue into the mouthpiece. Do not bend your neck.
Blow out as hard as you can.
It is best to do the test
standing or sitting upright.
After exhalation, slowly remove the
device from the mouth and check
the data on the smartphone.
When mSpirometer sensor
is out of your mouth, avoid
sudden movements. These
movements push air into
the turbine and affect the
test results.
Repeat the test three times.
mSpirometer sensor will save
the highest value.
5
6 7
mSpirometer™ sensor

10
1.3 Information on the parameters measured by mSpirometer sensor
PEF is the maximum flow rate of air exhaled forcefully from a position of full inspiration.
FEV1 is the volume of air expelled during the first second of the same exhalation. FVC is the volume of air
expelled during the total exhalation.
FEV1/FVC is a ratio that represents how much air you can blow out forcefully in one second over the total
amount of air you can exhale over 6 or more seconds.
FEV6 is the volume of air expelled during the first six seconds of exhalation.
FEF25-75 is the average of the flow at the middle portion (25%-75%) of a forced exhalation.
For each of these parameters, the result is a number shown on the smartphone screen.
© Cohero Health, Inc 2018
2.4.1 Evaluating the test
Three tests are performed per measurement session, after which the BreatheSmart application
automatically selects the highest value and compares it with the baseline value (predicted value or
personal best) set during configuration.
2.4.2 Results diary
The test results are automatically stored on the smartphone and can be displayed later. Medical studies
have shown that if your healthcare provider examines the test results on a regular basis, respiratory
disease can be managed much better.
2.5 Important safety warnings
Warning: indicates a potentially hazardous situation which, if not prevented, could result
in minor or moderate injury to the user or patient or damage the device.
Special WARNING should be given to testing elderly subjects, children and differently-able persons
The manufacturer cannot be held responsible for damage caused by the failure of the user to follow
these instructions correctly.
Only original accessories as specified by the manufacturer must be used with the device.
Check periodically that no impurities or foreign bodies, such as skin or hair have deposited inside the
turbine. Foreign matter may cause errors in measurement or compromise the correct functioning of
the device.
Use of an unsuitable mouthpiece could also damage the turbine or harm the patient. In the event of
an accident of any kind arising from use of the device, you are strongly recommended to inform your
healthcare provider so that he/she can notify the authorities as required by local legislation.
The device is not designed to be used in direct air currents (e.g. wind ceiling fan), sources of heat or
cold, direct sun rays or other sources of light or energy, or dust.
Use and store the device in compliance with the environmental conditions specified in the Technical
Specifications. If the device is subjected to environmental conditions other than those specified, it
may malfunction and/or display incorrect results.
!
!
!
!
!
!
!
mSpirometer™ sensor