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
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 specic 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
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 airow. 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 airow 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 airow from one measurement to the next
depends upon how dierent 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 Eects 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
!
!
!
!
!
!
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
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