MIR SMARTONE User manual

Smart One
Page 1 of 33
User Manual
Rev.2.9
®
PEAK FLOW AND FEV1 METER
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 FLOW AND FEV1 METER
AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
User Manual Rev 2.9 Issue Date October 03, 2017
0476
is registered trademark of MIR S.r.l. MEDICAL INTERNATIONAL RESEARCH

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Date
Measurements
Recommendation
Physician
PEF
FEV1
Reserved for the physician or other licensed health care professional to write your good
flow rates and to provide specific interventions he/she recommends for ranges of
decreased flow rates.

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CONTENTS
1. IMPORTANT INFORMATION CONCERNING INTENDED USE ............................................5
2. DETERMINING YOUR PEF OR FEV1 BASELINE VALUE......................................................6
3. WARNINGS AND PRECAUTIONS......................................................................................8
4. HOW TO START USING THE MIR SMART ONE APP..........................................................9
5. HOW SMART ONE WORKS............................................................................................10
5.1 Diary record........................................................................................................12
5.2 Self–measuring of PEF or FEV1 value..................................................................13
5.3 Interpreting results.............................................................................................16
6. IMPORTANT SAFETY WARNINGS ..................................................................................17
6.1 Data security warnings .......................................................................................18
6.2 Warnings for use in electromagnetic environments...........................................18
6.3 Notes on fcc certification....................................................................................19
7. CARE AND CLEANING....................................................................................................19
7.1 Cleaning and disinfection of the turbine.............................................................20
7.2 Cleaning and disinfection of the mouthpiece .....................................................21
7.3 Cleaning of the device ........................................................................................21
7.4 Replacing batteries.............................................................................................21
8. ERROR MESSAGES ........................................................................................................22
9. TROUBLESHOOTING .....................................................................................................23
10. Accuracy and Reliability................................................................................................24
11. LABELS & SYMBOLS ......................................................................................................24
12. TECHNICAL SPECIFICATIONS.........................................................................................26
13. Bluetooth Wireless Technology Information ................................................................27
13.1 Radio frequency (rf) communication..................................................................28
13.2 Radio frequency (rf) interference from other wireless devices...........................28
14. INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT............29
15. WARRANTY TERMS.......................................................................................................32

Smart One
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User Manual
Rev.2.9
Before connecting SMART ONE to a smartphone, install the MIR SMART ONE free app,
which you can download from the App Store (for iPhone and iPad) or 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 below.
Keep the original packaging! If your product has a problem, use the original packaging to
ship it back to your local distributor
The manufacturer cannot be held responsible for any damage caused by users failing
to follow the instructions contained in this manual.

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1. IMPORTANT INFORMATION CONCERNING INTENDED USE
Smart One 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,
adolescent and adult subjects. Smart One is indicated for monitoring asthma, COPD and
other respiratory diseases.
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 SMART ONE 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 or
FEV1 with a physician or other licensed healthcare professional, have proved to be
excellent methods that allows individuals with asthma, COPD (chronic obstructive
pulmonary disease) and other lung disease to better manage their conditions.
It is important to watch for changes in your PEF or FEV1 from one measuring to the next,
and to 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 or FEV1 to watch your disease and
discover if there are changes in your airflow. When you blow into the mouthpiece of the
flow 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 SMART ONE regularly, you will be able to detect changes in your PEF or FEV1, 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 SMART ONE meter. They also will explain how your PEF

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or FEV1 measurements help them monitor your lung function and how well treatments are
working.
2. DETERMINING YOUR PEF OR FEV1 BASELINE VALUE
A PEF or FEV1 measure with a high value usually means that your airflow is good.
The best way to determine what is a healthy PEF or FEV1 for you is to discuss this with
your physician or other licensed healthcare professional. In fact the importance of any
changes in airflow from one measuring to the next depends upon how much they are
different from your baseline value you should reach 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 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 reach when you are in the healthiest physical condition.
The MIR SMART ONE app can calculate the PEF or FEV1 predicted value, i.e. the expected
value for healthy people, depending on age, height, sex, and origin. MIR SMART ONE app
calculate the PEF or FEV1 predicted value that has been endorsed by ATS (American
Thoracic Society): for PEF the 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 Effects of Age, AM REV RESPIR DIS, 1976 113;587-600;
for FEV1 the predicted values are calculated according to GLI-2012 All-Age Multi-Ethnic
Reference Values by Philip H. Quanjer, Sanja Stanojevic, Janet Stocks, Tim J. Cole.
In this case, the predicted value becomes the baseline value for your treatment plan. If
your physician or other licensed healthcare professional prefers this method, MIR SMART
ONE app provides the calculation of the predicted PEF or FEV1 value.
It is important to know that these predicted values are average numbers for large groups
of people. You may have a higher PEF or FEV1 measures than the predicted value and you
may not be healthy. Or you may have a lower PEF or FEV1 than the average and be
healthy.

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PEF table Male (L/m)
Height (cm)
120
130
140
150
160
170
180
190
200
AGE
5
128
175
221
268
315
362
409
455
502
10
178
224
271
318
365
412
458
505
552
15
227
274
321
368
415
461
508
555
602
20
277
324
371
418
464
511
558
605
652
25
265
321
378
434
490
547
603
660
716
30
254
311
367
423
480
536
593
649
705
35
244
300
357
413
469
526
582
639
695
40
233
290
346
402
459
515
572
628
684
45
223
279
336
392
448
505
561
618
674
50
212
269
325
381
438
494
551
607
663
55
202
258
315
371
427
484
540
597
653
60
191
248
304
360
417
473
530
586
642
65
181
237
294
350
406
463
519
576
632
70
170
227
283
339
396
452
509
565
621
75
160
216
273
329
385
442
498
555
611
80
149
206
262
318
375
431
488
544
600
85
139
195
252
308
364
421
477
534
590
90
128
185
241
297
354
410
467
523
579
PEF table female (L/m)
Height (cm)
120
130
140
150
160
170
180
190
200
AGE
5
165
194
224
253
283
312
341
371
400
10
212
241
271
300
330
359
388
418
447
15
259
289
318
347
377
406
436
465
494
20
279
308
338
367
396
426
455
485
514
25
271
301
330
359
389
418
448
477
506
30
264
293
323
352
381
411
440
470
499
35
256
286
315
344
374
403
433
462
491
40
249
278
308
337
366
396
425
455
484
45
241
271
300
329
359
388
418
447
476
50
234
263
293
322
351
381
410
440
469
55
226
256
285
314
344
373
403
432
461
60
219
248
278
307
336
366
395
425
454
65
211
241
270
299
329
358
388
417
446
70
204
233
263
292
321
351
380
410
439
75
196
226
255
284
314
343
373
402
431
80
189
218
248
277
306
336
365
395
424
85
181
211
240
269
299
328
358
387
416
90
174
203
233
262
291
321
350
380
409

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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.
3. 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 SMART ONE 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 SMART ONE AND HOW TO
DECIDE ON AN APPROPRIATE ACTION PLAN INCLUDING WHICH PARAMETER TO USE, PEF
OR FEV1.
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 PEF OR FEV1
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 PEF OR FEV1 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.

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FOLLOW INSTRUCTIONS CAREFULLY IN ORDER TO GET AN ACCURATE READING OF
YOUR PEF OR FEV1 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 SMART ONE BEFORE YOU RELY ON ANY MEASUREMENTS.
MODIFYING YOUR ACTION PLAN OR MODIFYING YOUR BASELINE VALUE FOR YOUR
PEF OR FEV1 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.
THE DEVICE SHOULD NOT BE USED BY MORE THAN ONE PERSON. IF MORE THAN
ONE PERSON WISHES TO USE THE DEVICE, ONE USER’S MEASUREMENTS MUST NOT BE
ATTRIBUTED TO ANOTHER AND BOTH TURBINE AND MOUTHPIECE MUST BE CLEANED
THROUGHLY AFTER EACH USE UNLESS MULTIPLE TURBINE AND MOUTHPIECE ARE
AVAILABLE.
IF ANOTHER PERSON INTENDS TO USE THE DEVICE PERMANENTLY, THE PREVIOUS
DATA STORED BY THE MIR SMART ONE APP MUST BE REMOVED AND THE NEW
BASELINE VALUE FOR PEF OR FEV1 MUST BE DEFINED ACCORDING TO A PHYSICIAN OR
OTHER LICENSED HEALTHCARE PROFESSIONAL.
4. HOW TO START USING THE MIR SMART ONE APP
Follow the instructions in the Maintenance section for correct battery insertion.
Before connecting SMART ONE to a smartphone, install the MIR SMART ONE free app,
which you can download from Apple Store (for iPhone and iPad) or from Play Store (for
Android devices).
Launch the MIR SMART ONE APP and carry out the following steps.
These are one–off operations that do not need to be repeated next time you enter the
app.

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a) Authorize data exchange with the Health app, which is already installed on your
smartphone. The user can decide whether or not to allow
the following data to be written to the Health app: height, weight, PEF and FEV1
the following data to be read from the Health app: height, weight, date of birth,
gender.
You can allow or deny authorization for each parameter.
b) Enter your personal details: date of birth, origin, weight, height, sex.
The MIR SMART ONE APP will use these data to calculate PEF or FEV1 baseline value, and
will use it to assign a colored marker to your test (green, yellow, red). Please refer to the
section DETERMINING YOUR PEF OR FEV1 BASELINE VALUE for a clear understanding of
the baseline value. If you don’t enter your data, a warning message will be issued.
Connection between SMART ONE and your smartphone is automatic. To check whether
there is a connection, read the messages from the app.
5. HOW SMART ONE WORKS
SMART ONE 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 SCIENTIFIC BASIS FOR PEF AND FEV1 HOME MEASUREMENT?
The first portable mechanical meter to measure PEF was introduced in 1959 by B. Wright.
The widespread use of this device to monitor children and adults has made it a popular
means of tracking the degree of respiratory conditions in patients with asthma and other
pulmonary conditions.
Inexpensive, small, portable, and easy to use electronic meters for evaluating respiratory
conditions are now widely available. They offer several advantages including the ability to
record PEF and FEV1, and to store and transfer data to a physician or other licensed
healthcare professional.

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SMART ONE provides a warning message if a test is not correctly performed, for example if
instead of blowing out as hard and fast as you can, you exhale too slowly. This is another
clear advantage compared to a mechanical peak flow meter that does not provide any
message.
PEF and FEV1 are measured during the same exhalation. When the test is correctly
performed, PEF is measured 0.10–0.15 seconds after the blow start, while FEV1 is
measured exactly 1.0 second after the blow start.
According to best current evidence from several scientific studies, research paper topics
and clinical expertise, both PEF and FEV1 have proven to be good indicators of airflow
function in health and illness that can indicate how well you are breathing, and can help
you determine if there are changes in your airflow. Regular measurements of PEF or 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:
Effective asthma self–management education requires:
•Self–monitoring of symptoms and/or lung function (PEF or FEV1)
•Written asthma action plan
•Regular medical review
The above indicates that when engaged in self–management of asthma, your lung
conditions can be effectively monitored according with the written action plan prepared
by a physician or a licensed healthcare professional.
CAUTION: A PHYSICIAN’S OR OTHER HEALTHCARE PROFESSIONAL’S ADVICE IS REQUIRED
TO INTERPRET THE MEANING AND IMPORTANCE OF THE MEASUREMENTS REPORTED BY
SMART ONE AND HOW TO DECIDE ON AN APPROPRIATE ACTION PLAN INCLUDING WHICH
PARAMETER TO USE, PEF OR FEV1.
SMART ONE connects to a smartphone via Bluetooth SMART technology. Connection is
automatic once the MIR SMART ONE APP has been installed on your smartphone.
Each measure of PEF or FEV1 is transferred from the device to the smartphone to be
displayed. Please use the colored indicator (green, yellow or red) following your physician’s

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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 SMART ONE 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 or FEV1 usually means air is moving easily through the lungs. When
asthma attacks occur air cannot move easily through the lungs and lower values of PEF or
FEV1 will be measured. It is generally recommended to take a measurement two or three
times a day, in the morning when you wake up and before you go to bed.
SMART ONE should also be used when you are feeling symptoms of breathing problems in
order to help you and your physician or other licensed 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 SMART ONE meter.
5.1 Diary record
The MIR SMART ONE APP keeps a record of your highest reading of PEF or FEV1 for both
morning and evening session, complete with date and time. Dots between consecutively
recorded readings are connected in order to form a trend graph. This on–going record is an
important part of your asthma action plan.
The MIR SMART ONE APP can transfer the measured data to your physician or other
licensed healthcare professional. When used properly, SMART ONE will help you and your
physician or licensed healthcare professional monitor your asthma or other lung disease to
provide the best treatment.
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 device with you the next time you visit your physician or other licensed healthcare
professional for a review of many readings.

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5.2 Self–measuring of PEF or FEV1 value
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 FLOW AND FEV1 METER AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED
HEALTHCARE PROFESSIONAL.
( )
ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTH CARE PROFESSIONAL TO WATCH YOU USE
THE PEAK FLOW METER. THIS WILL HELP ASSURE YOU ARE USING IT CORRECTLY.
NO MATTER WHAT YOUR PEAK FLOW MEASURES ARE, IF YOU HAVE SIGNS AND
SYMPTOMS SUCH AS CHEST TIGHTNESS, SHORTNESS OF BREATH, COUGHING OR
WHEEZING YOU SHOULD FOLLOW YOUR LICENSED HEALTH CARE PROFESSIONAL'S
ADVICE FOR CONTACTING HIM OR HER.
IF YOU ARE UNABLE TO OBTAIN A READING YOU SHOULD CONTACT YOUR PHYSICIAN
IMMEDIATELY.
SMART ONE must be cleaned as shown in CARE AND CEANING section before your initial
trial and periodically thereafter.
To carry out a measurement:
Run the MIR SMART ONE APP on your smartphone
Press the START icon
Wait for Bluetooth connection

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1
Push the turbine into the slot until it stops
2
Turn the turbine clockwise until it stops
3
Insert mouthpiece at least 0.5 cm into the
turbine socket.
4
Your SMART ONE is now ready.
Hold SMART ONE with your hand as if
it were a cell phone and make sure
not to obstruct the turbine with your
hand.

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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 affect 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 difference 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 result on the
screen of your smartphone.
This is your PEF (or FEV1) measure.
NOTE: Avoid long slow exhalation
Since each test session should consist
of three trials, repeat steps 4–7 twice
more.
SMART ONE will save the highest
value.
Warning: Supervision of an adult is required for testing elderly subjects, children and
differently-able persons

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5.3 Interpreting results
Three tests are performed per each session, after
which the MIR SMART ONE APP automatically
selects and save the highest PEF or FEV1 value and
compares it with the baseline value. The app shows
a graphic marker (green, yellow or red), which is
then displayed as a colored circle around the test
result.
If you use SMART ONE to watch asthma, a reduction
of your PEF or FEV1 from one measuring time to the
next may mean that your asthma is getting worse.
The meaning of the graphic marker is displayed in
the following table.
COLOR
RESULT
MEANING
ACTION
Green
Above 80% of the baseline
OK
Your breathing condition appears
under control. Your medication is
working. Go ahead with your normal
activities.
Yellow
Above 50% and below or
equal to 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 or equal to 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 SMART ONE BEFORE YOU RELY ON ANY MEASUREMENTS.
CAUTION: WHEN SMART ONE IS USED TO MONITOR LUNG CONDITIONS SUCH AS ASTHMA
YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE
PROFESSIONAL.

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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 PEF OR FEV1 MEASURES.
CAUTION: NO MATTER WHAT YOUR PEF OR FEV1 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.
6. 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 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.
Periodically check that no impurities or foreign bodies, such as skin, hairs 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 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.
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, reconfigurations must be performed by the
manufacturer or by authorized personnel. In case of problems, do not try to repair the
device yourself.

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6.1 Data security warnings
Your smartphone stores your personal data.
Potential threats such as the following:
Malware installation
Physical access to the smartphone
Interception of communications
Physical damage to the smartphone
Theft of the smartphone
could have an impact on the integrity or confidentiality of such data, such as:
Accessing data in memory by unauthorized persons
Loss of data in memory
Inability to use smartphone for communications
The integrity check of the data is made automatically and in case of transmission error
it will create a corruption of the data and the file will be illegible
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 where to send the test results
When data are transmitted call the physician to ask for confirmation of receipt
6.2 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.
SMART ONE 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:

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Make sure that the SMART ONE and the smartphone on which the MIR SMART ONE
APP is installed are no more than 2 metres apart.
Do not use SMART ONE near other devices (computers, cordless phones, cell phones,
etc.) that generate strong electromagnetic fields. Keep such equipment at a minimum
distance of 7 metres.
6.3 Notes on fcc certification
SMART ONE 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. 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.
7. CARE AND CLEANING
SMART ONE is a device that requires little maintenance. The following operations are to
be performed regularly:

Smart One
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User Manual
Rev.2.9
Cleaning and disinfection of the turbine
Cleaning and disinfection of the mouthpiece
Cleaning of the device
Replacing batteries
7.1 Cleaning and disinfection of the turbine
To avoid irreparable damage to the turbine, do not use any alcoholic or oily cleaning
solutions, and do not immerse in hot water or solutions. 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 there are no liquid detergents, the turbine must at least be washed in
clean water.
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 hairs,
sputum etc.) could 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 SMART ONE socket by turning it counterclockwise
and simply pulling it out. To make it easier to pull out, push the base of the turbine gently
with a finger. 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.