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.
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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 ........................................................................................................
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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The maintenance operations set out in the User Manual must be carried out with the utmost care.
Failure to follow the instructions may lead to measurement errors or misinterpretation of the
measured values.
Do not modify the device without authorization from the manufacturer.
All modifications, adjustments, repairs and reconfigurations must be performed by the manufacturer
or by authorized personnel.
In case of problems, do not try to repair the device yourself.
2.6 Data security warnings
Your smartphone stores your personal data. Potential risks of use include:
• Malware installation
• Physical access to the smartphone
• Interception of communications
• Physical damage to the smartphone
• Theft of the smartphone
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These events could have an impact on the integrity or confidentiality of the data, such as:
• Access to data by unauthorized persons
• Loss of data in memory
• Inability to use smartphone for communications
The following actions help reduce the risk of such events:
• Do not open or install files from suspicious sources
• Use antivirus software
• Back up your data periodically
• Do not leave your smartphone unattended
• Use a password to access the data
• Verify the correct email address to which the test results should be sent
• Call your healthcare provider to ask for confirmation of receipt when data is transmitted
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• Make sure that the mSpirometer sensor and the smartphone on which the BreatheSmart
application is installed are no more than 2 meters apart.
• Do not use mSpirometer sensor near other devices (computers, cordless phones, cell phones, etc.)
that generate strong electromagnetic fields. Keep such equipment at a minimum distance of 7 meters.
2.7 Warnings for use in electromagnetic environments
Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.),
medical devices may be susceptible to electromagnetic interference from other equipment.
Such electromagnetic interference could cause the medical device to malfunction and create a potentially
unsafe situation.
mSpirometer sensor complies with EN 60601-1-2:2007 on electromagnetic compatibility
(EMC for medical devices) for both immunity and emissions.
For the device to function properly, however, the following precautions must be taken:
2.8 Notes on FCC certification
mSpirometer sensor complies with Part 15 of the FCC Rules. Operation is subject to the following conditions:
(1) this device may not cause harmful interference
(2) this device must accept any interference received, including interference that may cause undesired
operation
Any modifications not expressly approved by this company could compromise use of the device by the user.
N.B.: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference when the equipment is operated in a residential installation. This equipment generates,
uses, and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However there is no guarantee that interference will not occur.
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If this device does cause interference to radio or television reception, which can be determined by turning
the device off and on, the user is encouraged to correct the interference by taking one of the following
measures:
• Reorient or relocate the antenna
• Increase the distance between the equipment and receiver
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/television technician for help.
3. CARE AND CLEANING
mSpirometer sensor is a device that requires little maintenance. The following operations are to be
performed regularly:
3.1 Cleaning and disinfecting of the turbine
Correct operation of the turbine is guaranteed only if it is "clean" and free of foreign objects that affect its
movement. The presence of dust or foreign bodies (such as hair, sputum, etc.) may slow or block the
moving parts of the turbine and make the result less accurate, or damage the turbine itself.
After each use, check the cleanliness of the turbine.
To clean the turbine, pull it out of the mSpirometer sensor socket, turn it counterclockwise and simply pull
it out. Pushing the base of the turbine gently with a finger may make removal easier.
Weekly cleaning is recommended. Immerse the turbine flowmeter in warmy soapy water and agitate the
turbine for 2-3 minutes.
The hand dishwashing detergent that was tested includes these ingredients: Aqua, coco glucoside, myristyl
glucoside, lauryl glucoside, sodium chloride, sodium gluconate, sodium citrate, allyl caproate, ethylene
brassylate, methyldihydrojasmonate.
Rinse in clean water and shake gently to remove any excess water. Allow to air dry on a towel. Store in a
clean, dry place in your home.
• cleaning and disinfecting of the turbine
• cleaning and disinfecting of the mouthpiece
• cleaning of the device
• replacing batteries
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Once dry, insert the turbine into the socket in the direction indicated by the screen-printed closed padlock
symbol on the mSpirometer sensor. To insert the turbine, push it down and turn clockwise until it stops.
Make sure it is fully inserted into the plastic container.
To avoid irreparable damage to the turbine, do not use any alcoholic or oily cleaning solutions,
and do not immerse in hot water or liquids.
Do not try to sterilize the turbine in boiling water.
Never try to clean the turbine under a direct jet of water or other liquids. If liquid detergent is
unavailable, the turbine must at minimum be washed in clean water.
3.2 Cleaning and disinfecting of the mouthpiece
Clean the mouthpiece after each use. To clean the mouthpiece, simply pull it apart from the turbine.
As with the turbine, immerse the mouthpiece in warm soapy water and agitate the mouthpiece for 2-3
minutes. Rinse in clean water and shake gently to remove any excess water. Allow to air dry on a towel.
Store in a clean, dry place in your home.
Once dry, press lightly to reattach the mouthpiece to the turbine.
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3.3 Cleaning the device
Clean the device once a day. To clean, wipe the device’s surfaces with a soft damp cloth. Dry with a soft
cloth, or allow to air dry. Ensure that all surfaces are completely dry. Never put the device into water or
other fluids.
3.4 Replacing batteries
The battery charge is continuously monitored by the device.
Remove the battery cover on the
back of the mSpirometer sensor
Remove the two batteries and replace
them with two new ones, making sure
that they are inserted as pictured.
Reattach the battery cover
Used mSpirometer sensor batteries should only be disposed of in special containers or preferably
returned to the dealer of the device or to a special collection center. Local regulations apply.
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4. ERROR MESSAGES & TROUBLESHOOTING
4.1 Error messages
If you encounter any problems when using the mSpirometer sensor a message will appear on the
smartphone display to warn of the malfunction.
MESSAGE SOLUTION
mSpirometer sensor needs you to turn
on Bluetooth
Don’t hesitate
To perform measurements with the device, you must activate
Bluetooth on the smartphone. Exit the application and
activate Bluetooth from the smartphone settings menu.
Blow out faster
Try again when ready.
Blow out longer Try again when ready.
Don’t start too early Try again when ready.
Try again when ready.
Abrupt end Try again when ready.
Avoid coughing Try again when ready.
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Low battery Replace the mSpirometer sensor batteries.
PROBLEM POSSIBLE CAUSE SOLUTION
mSpirometer
sensor can’t
connect with the
smartphone
The Bluetooth connection
is not working properly
Look for mSpirometer sensor on the list of recognized devices.
For correct use, the smartphone needs Bluetooth version 4.0
or higher.
The test results
are unreliable
The turbine may be dirty
The test was performed
incorrectly
Clean the turbine as described in the Maintenance section.
Repeat the test, following the directions on the screen. Avoid
sudden movements once you have finished exhaling.
The turbine has not been
inserted properly
The mSpirometer sensor
batteries are below 15%
Insert the turbine from the front of the device by pushing it all the way
down and turning it clockwise. See the Performing the test section.
4.2 Troubleshooting
An unusually low reading could mean that your respiratory condition is worse than usual.
Make sure that the sensor is not broken. You must follow directions exactly as instructed in order to
obtain accurate results. If your sensor is not broken, follow the instructions in your action plan for low
readings and contact your physician or other licensed healthcare professional.
Clean the turbine as described in the Maintenance Section.
If problems occur when using the device, the following points should be checked.
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This device meets the requirements of the following standard:
ATS/ERS TASK FORCE: Standardization of lung function testing (volume 26/numbers 1-5: 2005)
Volume max 10 L
Volume accuracy ± 3% or 0.05 L
Flow range 960 L/minute
Flow accuracy ± 5% or 10.2 L/minute
5. ACCURACY AND RELIABILITY
mSpirometer™ sensor
Time zero
At the point of peak expiratory flow (PEF), a tangent is
drawn with a slope equal to PEF and its intersection on
the abscissa defines the TIME ZERO. The back extrapolated
volume is the volume of gas that has already been exhaled
at the point of TIME ZERO as defined by back extrapolation.
The method to determine the time elapsed by TIME ZERO,
t0, is given by equation:
Time zero = tPEF - (VPEF/PEF)
Where
PEF is the the peak expiratory flow;
tPEF is the the elapsed time at PEF;
VPEF is the the expired volume at PEF
Time zero
Time (sec)
Volume (V)
Back extrapolation
Extrapolated volume
2.0
1.5
1.5
1.0
1.0
0,5
0,5
0,0
0,0
Image results for time zero spirometry

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6. LABELS & SYMBOLS
ID label
The label shows:
• Model
• Device serial number (SN)
• Manufacturer’s name and address
• Prescription only symbol
• Electrical safety symbol
In accordance with IEC 60601-1 the product and its applied parts are type BF and thus protected against
the risks of electrical leakage.
This symbol is required by European directive 2002/96/EEC on waste electrical and electronic equipment
(WEEE). At the end of its useful life this device must not be disposed of as normal domestic waste. Instead it
must be delivered to a WEEE authorised collection centre.
As an alternative, the device may be returned without charge to the dealer or distributor, when it is replaced by
another equivalent device.
Due to the construction materials used for the device, disposal as normal waste could cause harm to the
environment and/or health.
Failure to observe these regulations can lead to prosecution.
IP22 Indicates the degree of resistance to liquids. The device is protected against falling drops of water if
it is disposed up to 15° from vertical.
IP22
SYMBOL DESCRIPTION
• WEEE Symbol
• Antenna symbol for devices that include RF transmitters
• FCC ID number
• Degree of protection against penetration by external agents (IP22)
• CE Mark
This indicates that this device should be dispensed on the order of a licensed healthcare professional.
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mSpirometer™ sensor
This product is a certified Class IIa medical device, and complies with the requirements of Directive 93/42/EEC
This indicates the manufacturer. MIR Medical International Research, Via del Maggiolino 125, Rome Italy.
Instructions for use symbol. Read the manual carefully before using the medical device

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The symbol is used in accordance with IEC EN 60601-1-2: 2007 in section 5.1.1 for products including RF
transmitters.
Identification showing traceability to FCC compliance.
7. TECHNICAL SPECIFICATIONS
Parameters measured:
FEV1
PEF
FVC
FEV1/FVC
FEV6
FEF 25-75
Flow/volume measurement system
Measurement principle
Dynamic resistance at 12 L/s
Communication interface
Power supply
Size
Weight
Type of electrical protection
Electrical protection level
IP protection level Regulations
Applicable standards
Expiratory volume in one second of testing
Peak expiratory flow
Forced Vital Capacity
Ratio of FEV1over FVC
Expiratory volume in six seconds of testing
Average forced expiratory flow in the middle of a six second test
Bi-directional turbine
Infrared interruption
<0.5 cm H2O/L/s
Bluetooth SMART (4.0 or higher)
2 x 1.5V AAA alkaline batteries
main body 109x49x21 mm
60.7 g (including batteries)
L
L/minute
L
%
L
L/second
mSpirometer™ sensor
Class II
BF
IP22
Electrical Safety IEC 60601-1
Electromagnetic Compatibility IEC 60601-1-2
ATS/ERS Standardization of spirometry 2005
ISO 26782
ISO 23747