Cohero Health cSpirometer User manual

1© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
cSpirometer™Sensor
Peak Flow and FEV1 Meter
Instructions for Use

2© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
IMPORTANT: Please read all the information in this user
manual before using this device. If you do not understand
these instructions or if you have questions about your peak
ow and FEV1 meter and its use consult your physician
or other licensed healthcare professional. If you do not
understand the instructions, contact Cohero Health, Inc.
at the below address or through the “Help” module in the
BreatheSmart®app.
Cohero Health, Inc.
12 E 49th Street
New York, NY 10017
www.coherohealth.com
[email protected]
Para instrucciones en español ir a:
coherohealth.com/manuals/es

3© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
Date
Measurements
Recommendation Physician
PEF FEV1
Reserved for the physician or other licensed health care professional to
write your good ow rates and to provide specic interventions he/she
recommends for ranges of decreased ow rates.

4© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
Table of Contents
1. Indications for Use.............................................................................................................. 2
2. Important Information Concerning Intended Use.................................................. 2
3. Determining Your PEF Baseline Value.......................................................................... 4
4. Warnings and Precautions................................................................................................ 6
5. How To Start Using the BreatheSmart®App.............................................................. 8
6. How cSpirometer™Sensor Works.................................................................................. 9
6.1. Peak Flow Results.................................................................................................................. 11
6.2. Self-Measuring of PEF and FEV1 Value........................................................................ 11
6.3. Interpreting Results.............................................................................................................. 14
7. Important Safety Warnings............................................................................................... 15
7.1. Data Security Warnings....................................................................................................... 17
7.2. Warnings for Use in Electromagnetic Environments............................................. 18
7.3. Notes on FCC Certification............................................................................................... 19
8. Care and Cleaning............................................................................................................... 20
8.1. Cleaning and Disinfection of the Turbine................................................................... 21
8.2. Cleaning and Disinfection of the Mouthpiece........................................................ 22
8.3. Cleaning of the Device...................................................................................................... 22
8.4. Replacing Batteries.............................................................................................................. 23
9. Error Messages...................................................................................................................... 24
10.Troubleshooting................................................................................................................. 25
11. Accuracy and Reliability................................................................................................... 26
12. Labels & Symbols............................................................................................................... 26
13. Technical Specifications.................................................................................................. 28
14. Bluetooth Wireless Technology Information........................................................... 30
14.1. Radio Frequency (RF) Communication..................................................................... 31
15. Warranty Items.................................................................................................................... 32

1© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
Before connecting cSpirometer™sensor to a smartphone, install the BreatheSmart
app, which you can download from the App Store (for iPhone) or Google Play Store
(for Android devices).
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 straight back for replacement.
Check if the packaging contains all the
items shown.
Keep the original packaging! If your product
has a problem, use the original packaging
to ship it back to your local distributor:
If you have any problems, contact Cohero
Health, Inc. at the below address or through
the “Help” module in the BreatheSmart app.
Cohero Health, Inc.
12 E 49th Street
New York, NY 10017
www.coherohealth.com
[email protected]
INCLUDES
Peak Flow and
FEV1 Meter
Plastic
Mouthpiece
2 AAA Batteries
Instructions for Use

2© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
Cohero Health, Inc. cannot be held responsible for any damage caused
by users failing to follow the instructions contained in this manual.
1. Indications for Use
cSpirometer sensor is intended for home use by patients to monitor PEF
(Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second).
The device is designed for children greater than ve years of age, adolescent
and adult subjects.
2. Important Information Concerning Intended Use
PEF is the maximum speed a person can blow air out of the lungs after taking
as big a breath as possible.
FEV1 is the maximum volume of air a person can exhale from the lungs in
one second after taking as big a breath as possible.
CAUTION: WHEN CSPIROMETER SENSOR IS USED TO MONITOR LUNG
CONDITIONS SUCH AS ASTHMA YOU SHOULD BE UNDER THE CARE OF A
PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
Medical studies have shown that regularly reviewing accurate measurements
of PEF and FEV1 with a physician or other licensed healthcare professional
may allow individuals with lung disease to better manage their conditions.
It is important to watch for changes from one measuring to the next, and to

3© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
follow the actions you have to take according to the action plan provided to
you by your physician or other licensed healthcare professional.
If you have breathing conditions such as asthma your physician or licensed
healthcare professional may recommend that you measure PEF/FEV1 to
watch your disease and discover if there are changes in your airow. When
you blow into the mouthpiece of the ow meter, the device will display a
number. The faster you blow, the higher the reading.
This number tells you how well air is moving through the airways in your
lungs. When you use cSpirometer sensor regularly, you will be able to detect
changes in your measurements, which will tell you and your physician or
other licensed healthcare professional what is happening with your lungs.
These changes may require special treatment of your condition according
to the action plan given to you by your physician or licensed healthcare
professional which will tell you when and how often to use your cSpirometer
sensor. They also will explain how your PEF and FEV1 measurements help
them monitor your lung function and how well treatments are working.

4© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
3. Determining Your PEF Baseline Value
A PEF measure with a high value usually means that your airow is good.
The best way to determine what is a healthy PEF for you is to discuss this
with your physician or other licensed healthcare professional. In fact the
importance of any changes in airow from one measurement to the next
depends upon how dierent they are from your baseline value when you are
in healthy physical condition.
Your physician or other licensed healthcare professional will use one of two
possible ways to identify your baseline value. The rst 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 reach when you
are in the healthiest physical condition.
The ATS (American Thoracic Society): PEF predicted values are calculated
according to Knudson, R. J., Slatin R. C., Lebowitz, M. D., Burrows, B., The Maximal
Expiratory Flow-Volume Curve – Normal Standards, Variability, and Eects of Age,
AM REV RESPIR DIS, 1976 113;587-600.
It is important to know that these predicted values are average numbers
for large groups of people. You may have a higher PEF measure than the
predicted value and you may not be healthy. Or you may have a lower PEF
than the average and be healthy.

5© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
PEF Table MALE (L/min)
Height (cm)
PEF Table FEMALE (L/min)
Height (cm)
120 130 140 150 160 170 180 190 200 120 130 140 150 160 170 180 190 200
5128 175 221 268 315 362 409 455 502 5165 194 224 253 283 312 341 371 400
10 178 224 271 318 365 412 458 505 552 10 212 241 271 300 330 359 388 418 447
15 227 274 321 368 415 461 508 555 602 15 259 289 318 347 377 406 436 465 494
20 277 324 371 418 464 511 558 605 652 20 279 308 338 367 396 426 455 485 514
25 265 321 378 434 490 547 603 660 716 25 271 301 330 359 389 418 448 477 506
30 254 311 367 423 480 536 593 649 705 30 264 293 323 352 381 411 440 470 499
A
G
E
35 244 300 357 413 469 526 582 639 695
A
G
E
35 256 286 315 344 374 403 433 462 491
40 233 290 346 402 459 515 572 628 684 40 249 278 308 337 366 396 425 455 484
45 223 279 336 392 448 505 561 618 674 45 241 271 300 329 359 388 418 447 476
50 212 269 325 381 438 494 551 607 663 50 234 263 293 322 351 381 410 440 469
55 202 258 315 371 427 484 540 597 653 55 226 256 285 314 344 373 403 432 461
60 191 248 304 360 417 473 530 586 642 60 219 248 278 307 336 366 395 425 454
65 181 237 294 350 406 463 519 576 632 65 211 241 270 299 329 358 388 417 446
70 170 227 283 339 396 452 509 565 621 70 204 233 263 292 321 351 380 410 439
75 160 216 273 329 385 442 498 555 611 75 196 226 255 284 314 343 373 402 431
80 149 206 262 318 375 431 488 544 600 80 189 218 248 277 306 336 365 395 424
85 139 195 252 308 364 421 477 534 590 85 181 211 240 269 299 328 358 387 416
90 128 185 241 297 354 410 467 523 579 90 174 203 233 262 291 321 350 380 409
CAUTION: no matter which method your physician or other licensed
healthcare professional prefers to use, it is important that you clearly
understand the meaning of your baseline value and how it relates to
your treatment plan. if you have trouble determining your baseline
value, ask your physician or other licensed healthcare professional for
assistance.

6© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
4. Warnings and Precautions
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Please read all the information in this user manual before using this
device. If you do not understand these instructions or if you have
questions about your PEF and FEV1 meter and its use consult your
physician or other licensed healthcare professional.
When cSpirometer sensor is used to monitor lung conditions such as
asthma you should be under the care of a physician or other licensed
healthcare professional.
A healthcare professional’s advice is required to interpret the meaning
and importance of the measurements reported by cSpirometer sensor
and how to decide on an appropriate action plan.
Diagnosis and appropriate treatments are to be given only by a physician
or other licensed healthcare professional. The action plan will tell you
what action to take when there are changes in your measures.
Self–measurement means control, not diagnosis or treatment. In
any event please be sure to discuss your measured values with your
physician or other licensed healthcare professional. They will also
explain which values are normal for you.
No matter what your measures are, if you have signs and symptoms
such as chest tightness, shortness of breath, coughing or wheezing you

7© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
should contact your physician or licensed health care professional.
Follow instructions carefully in order to get an accurate reading of your
measures. If you are unable to obtain a reading, contact your healthcare
professional.
Ask your physician or other licensed health care professional to
watch you use your cSpirometer sensor before you rely on any
measurements.
Modifying your action plan or modifying your baseline value for your PEF
measurement should only be done with direction from your physician
or other licensed healthcare professional. Discuss with your physician
before proceeding.
You should never alter the dosage of any medication without talking to
your physician.
If the device is used by another person, the mouthpiece and turbine
must be disinfected, as explained in the Maintenance section, or a
new turbine and mouthpiece should be used. Make sure one person’s
measurements are not being attributed to another.
If another person intends to use the device permanently, the new user
must create a new BreatheSmart app account. A new PEF baseline value
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8© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
can be dened according to a physician or other licensed healthcare
professional.
5. How To Start Using the BreatheSmart®App
Follow the instructions in the Maintenance section for correct battery
insertion.
Before connecting the cSpirometer sensor to a smartphone, install the
BreatheSmart app.
DOWNLOAD AND INSTALLATION
BreatheSmart app may be downloaded from the App Store for iPhones or
Play Store for Android.
SIGN UP OR LOG IN
Once you have installed the BreatheSmart app on your phone, tap the
BreatheSmart app icon on your phone’s home screen. Create your account
and follow the in-app prompts.
MEASURING PEAK FLOW
yNavigate to the menu
ySelect the Peak Flow menu item
yFollow the onscreen prompts

9© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
6. How cSpirometer™Sensor Works
cSpirometer sensor is an electronic device for home use that accurately
measures your PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory
Volume in 1 sec).
PEF is the maximum speed a person can blow air out of the lungs after
taking as big a breath as possible while FEV1 is the maximum volume of air a
person can exhale from the lungs in one second after taking as big a breath
as possible.
What is the Scientic Basis for PEF and FEV1 Home Measurement?
According to best current evidence from several scientic studies, research paper topics
and clinical expertise, both PEF and FEV1 have proven to be good indicators of airow
function in health and illness that can indicate how well you are breathing and can help
you determine if there are changes in your airow. Regular measurements of PEF and
FEV1 provide evidence of disease progression.
The GUIDE FOR ASTHMA MANAGEMENT AND PREVENTION published in 2016 by
GINA (Global Strategy for Asthma Management and Prevention) states:
Eective asthma self–management education requires:
ySelf–monitoring of symptoms and/or lung function
yWritten asthma action plan
yRegular medical review
The above indicates that when engaged in self–management of asthma, your lung
conditions can be eectively monitored according with the written action plan
prepared by a physician or a licensed healthcare professional.

10© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
CAUTION: A physician’s or other healthcare professional’s advice is required
to interpret the meaning and importance of the measurements reported by
cSpirometer sensor and how to decide on an appropriate action plan.
cSpirometer sensor connects to a smartphone via Bluetooth SMART
technology. Connection is automatic once the BreatheSmart app has been
installed on your smartphone.
Each measure of PEF and FEV1 is transferred from the device to the
smartphone to be displayed. Please use the PEF colored indicator (green,
yellow or red) following your physician’s or other licensed health care
professional’s advice. They will help you determine how to perform the test
accurately and recommend actions when decreased values are measured.
CAUTION: when cSpirometer sensor is used to monitor lung conditions
such as asthma you should be under the care of a physician or other licensed
healthcare professional.
A higher value of PEF and FEV1 usually means air is moving easily through
the lungs. When asthma attacks occur air cannot move easily through the
lungs and lower values will be measured. It is generally recommended to take
measurements as directed by licensed healthcare professionals.
cSpirometer sensor should also be used when you are feeling symptoms of
breathing problems in order to help you and your physician or other licensed

11© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
healthcare professional determine how serious the breathing problem is
and how well your treatment is working. Discuss with your physician or
other licensed healthcare professional when and how often to use your
cSpirometer sensor.
6.1 Peak Flow Results
The test results are automatically stored on the smartphone and can be
displayed later.
Reviewing the measured data can help you and your physician or other
licensed healthcare professional check closely on your respiratory disease to
provide the best treatment for you.
Because your smartphone has an automatic memory of hundreds of
readings, you can take the phone with you the next time you visit your
physician or other licensed healthcare professional for a review of many
readings.
6.2. Self-Measuring of PEF and FEV1 Value
Ask your physician or other licensed health care professional to watch you use the
peak ow meter. This will help assure that you are using it correctly.
cSpirometer sensor must be cleaned as shown in the Care and Cleaning
section before your initial trial and periodically thereafter.

12© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
To carry out a measurement:
yRun the BreatheSmart app on your smartphone
yOpen the Peak Flow Module from the menu
yPress the Take Measurement button
yFollow in-app instructions to complete a measurement
1Push the turbine into the slot
until it stops 2Turn the turbine clockwise until it stops
3Insert mouthpiece at least 0.5 cm
into the turbine socket. 4Your cSpirometer sensor is now
ready.
Hold cSpirometer sensor with your hand as if it
were a cell phone and make sure not to obstruct
the turbine with your hand.

13© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
5
Insert the mouthpiece end into your mouth beyond your teeth, and close
lips around the mouthpiece. Make sure your lips form a tight seal around the
mouthpiece.
To prevent turbulence that might otherwise aect the results do not put your tongue in the
mouthpiece. Do not bend your neck.
6
It is best to do the test standing or
sitting upright (makes no dierence
to test results).
7
• Take a slow deep breath as deep
as you can.
• Blow out as hard and fast as you
can until you can read the results on
the screen of your smartphone.
• This is your PEF and FEV1 measure.
NOTE: Avoid long slow exhalation.
Since each test session should consist
of three trials, repeat steps 4-7 twice
more.
cSpirometer sensor will save the
highest value.
Warning: Supervision of an adult is required for testing elderly subjects, children greater than ve
years of age and dierently-able persons.

14© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
6.3. Interpreting Results
BreatheSmart app requires you to complete three successful exhalations
before displaying nal results. This is a standard clinical practice to ensure
reproducibility and best results. The best result of the session is saved as
your nal score.
Color Result Meaning Action
Green
80% and
above of the
baseline
OK
Your breathing condition appears under
control. Your medication is working. Go ahead
with your normal activities.
Yellow
Between
50% and
80% of the
baseline
Warning
Use caution in your activity. Refer to your
action plan made by your physician or other
licensed healthcare professional for action to
be taken.
Red
Below
50% of the
baseline
Danger
Medical alert. You should get immediate
medical attention. Act as discussed with
your physician or other licensed healthcare
professional.
CAUTION: Ask your physician or other licensed healthcare professional
to watch you use your cSpirometer sensor before you rely on any
measurements.
CAUTION: When cSpirometer sensor is used to monitor lung conditions
such as asthma you should be under the care of a physician or other licensed
healthcare professional.

15© 2019 Cohero Health, Inc.
cSpirometer™Sensor Instructions for Use
®
CAUTION: The action plan given to you by your physician or other licensed
health care professional will tell you what action to take when there are
changes in your measurements.
CAUTION: No matter what your measures are, if you have signs and
symptoms such as chest tightness, shortness of breath, coughing or
wheezing you should contact your physician or licensed health care
professional.
7. 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.
Supervision of an adult is required for testing elderly subjects, children
greater than ve years of age and dierently-abled persons.
Cohero Health, Inc. cannot be held responsible for damage caused by
the failure of the user to follow these instructions correctly.
Only original accessories as specied by the manufacturer must be used
with the device.
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16© 2019 Cohero Health, Inc.
®
cSpirometer™Sensor Instructions for Use
Periodically check that no impurities or foreign bodies, such as skin
or hair, have deposited inside the turbine. This may cause errors in
measurement or compromise the correct functioning of the device.
Do not drop the device or treat it roughly in any way. Avoid strong
vibration. Do not expose the device to extreme temperature, humidity,
dust, sand, or chemical substances, or direct air currents (e.g. wind),
sources of heat or cold, direct sunrays or other sources of light or
energy.
Use and store the device in compliance with the environmental
conditions specied in the Technical Specications. If the device is
subjected to environmental conditions other than those specied, it may
malfunction and/or display incorrect results.
The maintenance operations set out in the Instructions for Use 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 Cohero Health,
Inc. All modications, adjustments, repairs, recongurations must be
performed by Cohero Health, Inc. or by authorized personnel. In case of
problems, do not try to repair the device yourself.
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