Smart One Oxi
English
Rev.2.0.1
User Manual
Page 1 of 40
Oxi ®
English (EN)
BEFORE USING THIS DEVICE READ A LL INFORMATION CONTAINED IN THIS USER MANUAL. IF YOU DO NOT
UNDERSTAND THESE INSTRUCTIONS OR IF YOU H AVE QUESTIONS ABOUT YOUR SP IROMETER AND ITS USE
CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
IF THE INSTRUCTIONS ARE NOT CLEAR:
USA:
Call MIR USA Tel + 1 (262) 565 - 6797 ; Fax + 1 (262) 364 - 2030, Monday to Friday 8 AM to 5 PM (central time),
or contact us at mirusa@spirometry.com, or write to us at MIR USA, 5462 S. Westridge Drive, New Berlin,
WI 53151 – USA.
EUROPE and WORLDWIDE:
Call MIR +39 06 22754777, Monday to Friday 8 AM to 5 PM (GMT+1), or contact us at mir@spirometry.com,
or write to us at MIR Via del Maggiolino 125, 00155 Rome, Italy.
User Manual Rev 2.0.1
Issue Date 14.03.2023
0476
Oxi
is registered trademark of MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.
Smart One Oxi
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Date
Measurements
Recommendation
Doctor
PEF
FEV1
Reserved for the physician or other licensed healthcare professional to write your positive
flow rates and to provide specific interventions he/she recommends for ranges of decreased
flow rates.
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CONTENTS
1. INTENDED USE ............................................................................................................. 5
2. IMPORTANT INFORMATION CONCERNING INTENDED USE ......................................... 5
3. DETERMINING YOUR PEF BASELINE VALUES................................................................ 6
4. WARNINGS AND PRECAUTIONS ................................................................................... 8
5. CONTRAINDICATIONS .................................................................................................. 9
6. HOW TO START TO USE THE MIR SMART ONE APP ................................................... 10
7. HOW SMART ONE OXI WORKS .................................................................................. 11
7.1 Control of registrations .................................................................................... 13
7.2 Self-measurement of PEF and FEV1 values ...................................................... 14
7.3 Performing the oximetry test .......................................................................... 17
7.4 How to interpret the results ............................................................................ 18
8. IMPORTANT SAFETY WARNINGS ............................................................................... 20
8.1 Data security warnings .................................................................................... 21
8.2 Warnings for use in electromagnetic environments ........................................ 21
8.3 Notes on FCC certification ............................................................................... 22
9. MAINTENANCE AND CLEANLINESS ............................................................................ 23
9.1 Cleaning of the reusable turbine ..................................................................... 23
9.2 Cleaning of the mouthpiece............................................................................. 27
9.3 Cleaning of the device ..................................................................................... 28
9.4 Replacing batteries .......................................................................................... 29
10. ERROR MESSAGES ..................................................................................................... 30
11. TROUBLESHOOTING .................................................................................................. 31
12. ACCURACY and reliability ........................................................................................... 32
13. LABELS & SYMBOLS ................................................................................................... 34
14. TECHNICAL SPECIFICATIONS ...................................................................................... 35
15. Information on Bluetooth Wireless technology ......................................................... 38
15.1 Communication at radiofrequency (RF) ........................................................... 39
15.2 Interference in radiofrequency (RF) caused by other wireless devices ............ 39
16. WARRANTY TERMS .................................................................................................... 40
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Before connecting SMART ONE OXI 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 it
looks damaged, do not use the device and return it directly to request replacement.
If there is, do not use the device and send it straight back for replacement.
Keep the original packaging! In the event of a problem with your product, use the original
packaging to ship it back to your local distributor.
MIR USA, INC.
5462 S. Westridge Drive
New Berlin, WI 53151 - USA
Tel + 1 (262) 565 – 6797 Fax + 1 (262) 364 – 2030
Website: www.spirometry.com Email: mirusa@spirometry.com
EUROPE and WORLDWIDE:
Call MIR +39 06 22754777, Monday to Friday 8 AM to 5 PM (GMT+1), or contact us at
mir@spirometry.com, or write us at MIR Via del Maggiolino 125, 00155 Roma, Italy.
The manufacturer cannot be held responsible for any damage caused by users failing to
follow the instructions contained in this manual.
Spirometer for
peak flow
and FEV1
Plastic mouthpiece
2 AAA batteries
User Manual
INCLUDES
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1. INTENDED USE
Smart One Oxi spirometer and pulse oximeter is intended to be used by a physician or by a
subject under the instructions of a physician or paramedic to assess lung function. The
device is designed for children of over five years of age, adolescents and adults, and can be
used at home, in a factory, pharmacy, hospital or medical surgery.
2. IMPORTANT INFORMATION CONCERNING INTENDED USE
PEF is the maximum speed a person can blow air out of the lungs after taking a very deep
breath.
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.
SpO2 is the percentage of oxygen saturation in the blood.
BPM is the heart rate.
WARNING: WHEN SMART ONE OXI 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 very important to watch for changes from one measurement to the next, and to follow
the actions you have to take according to the plan of action provided to you by your
physician or other licensed healthcare professional.
If you have respiratory 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 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 OXI 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.
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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 OXI meter. They also will explain how your PEF and
FEV1 measurements help them monitor your lung function and how well treatments are
working.
3. DETERMINING YOUR PEF BASELINE VALUES
A PEF measure with a high value usually means that your airflow 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. The importance of any changes in airflow from
one measuring to the next depends upon how much they are different from the 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, gender 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 predicted value, i.e. the expected value for
healthy people, depending on age, height, gender, and origin. MIR SMART ONE app
calculate the predicted value endorsed by 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 Effects of
Age, AM REV RESPIR DIS, 1976 113;587-600.
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 value.
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.
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PEF table Male (L/min)
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
Female PEF values (l/min)
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
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90
174
203
233
262
291
321
350
380
409
WARNING: INDEPENDENTLY OF THE METHOD CHOSEN BY YOUR DOCTOR OR OTHER
LICENSED HEALTH PROFESSIONAL, THE PATIENT MUST CLEARLY UNDERSTAND THE
MEANING OF THE BASELINE VALUE AND HOW IT INFLUENCES THE TREATMENT PLAN. IF
IN DIFFICULTY REGARDING ESTABLISHING YOUR OWN BASELINE VALUE, ASK FOR HELP
FROM YOUR PHYSICIAN OR ANOTHER LICENSED HEALTH PROFESSIONAL.
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 FLOWMETER FOR MEASURING PEF AND FEV1 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.
TO INTERPRET THE MEANING AND SIGNIFICANCE OF A MEASUREMENT TAKEN USING
SMART ONE OXI AND TO DECIDE ON AN APPROPRIATE PLAN OF ACTION, BE SURE TO
CONSULT A HEALTHCARE PROFESSIONAL, ALSO IN VIEW OF THE FACT THAT THE DEVICE IS
NOT EQUIPPED WITH ALARMS.
APPROPRIATE DIAGNOSIS AND TREATMENT CAN ONLY BE PROVIDED BY A PHYSICIAN
OR OTHER LICENSED HEALTHCARE PROFESSIONAL. THE PLAN OF ACTION WILL INDICATE
WHICH ACTION IS TO BE TAKEN WHEN THERE ARE CHANGING MEASUREMENTS.
SELF-MEASUREMENT MEANS CHECKING, NOT DIAGNOSING OR CHOOSING A
TREATMENT. IF ANY EVENT OCCURS SHOW YOUR MEASUREMENTS TO YOUR PHYSICIAN
OR OTHER LICENSED HEALTHCARE PROFESSIONAL. THEY WILL ALSO EXPLAIN WHICH ARE
THE NORMAL VALUES FOR YOU.
INDEPENDENTLY OF YOUR VALUES, IF YOU ARE SHOWING SIGNS AND SYMPTOMS
SUCH AS THORACIC CONSTRICTION, SHORT BREATH, COUGH OR DYSPNOEA, CONTACT
YOUR PHYSICIAN OR A LICENSED HEALTHCARE PROFESSIONAL.
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TO OBTAIN ACCURATE MEASUREMENTS, CAREFULLY FOLLOW THE INSTRUCTIONS. IF
YOU CANNOT OBTAIN A VALUE, CONTACT YOUR HEALTHCARE PROFESSIONAL.
ASK YOUR PHYSICIAN OR LICENSED HEALTHCARE PROFESSIONAL TO WATCH YOU
USING THE SMART ONE BEFORE RELYING ON ANY MEASUREMENT.
MODIFYING THE PLAN OF ACTION OR THE BASELINE VALUES MUST BE CARRIED OUT
ONLY FOLLOWING INDICATIONS OF YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE
PROFESSIONAL. SPEAK WITH YOUR PHYSICIAN BEFORE PROCEEDING.
NEVER CHANGE DRUG DOSES WITHOUT FIRST AGREEING THEM WITH YOUR
PHYSICIAN.
THE DEVICE SHOULD NOT BE USED BY MORE THAN ONE PERSON. IF MORE THAN ONE
PERSON WISHES TO USE IT, THE MEASUREMENT OF EACH PERSON SHOULD BE
ATTRIBUTED CORRECTLY AND BOTH THE TURBINE AND THE MOUTHPIECE MUST BE
CLEANED CAREFULLY FOLLOWING EACH USE UNLESS MORE THAN ONE
MOUTHPIECE/TURBINE IS AVAILABLE.
IF ANOTHER PERSON INTENDS TO USE THE DEVICE EXCLUSIVELY, THE PREVIOUSLY
SAVED DATA ON THE MIR SMART ONE APP MUST BE DELETEDAND A NEW BASELINE
MEASUREMENT WILL HAVE TO BE ESTABLISHED ACCORDING TO WHAT IS ESTABLISHED BY
THE PHYSICIAN OR THE LICENSED HEALTHCARE PROFESSIONAL.
5. CONTRAINDICATIONS
The ATS/ERS guideline updated 2019 sets out the relative contraindications of spirometry
as follows.
Due to increased myocardial demand or changes in blood pressure: Acute myocardial
infarction within 1 week; Systemic hypotension or severe hypertension; Significant
atrial/ventricular arrhythmia; Uncompensated heart failure; Uncontrolled pulmonary
hypertension; Acute pulmonary heart; Clinically unstable pulmonary embolism; History of
syncope related to forced expiration/cough.
Due to increased intracranial/intraocular pressure: Cerebral aneurysm; Brain surgery within
4 weeks; Recent concussion with persistent symptoms; Eye surgery within 1 week.
Due to increased sinus and middle ear pressure: Sinus or middle ear surgery or infection
within 1 week.
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Due to increased intrathoracic and intraabdominal pressure: Presence of pneumothorax;
Thoracic surgery within 4 weeks; Abdominal surgery within 4 weeks; Over term pregnancy.
Due to infection control problems: Active or suspected transmissible respiratory or systemic
infection, including tuberculosis; Physical conditions predisposing to transmission of
infection, such as haemoptysis, significant discharge or oral injury or oral bleeding.
The medical professional is obliged to assess the patient's health condition before he
or she performs spirometry.
6. HOW TO START TO USE THE MIR SMART ONE APP
Follow the instructions in the Maintenance section for correct battery insertion.
Before connecting SMART ONE OXI to a smartphone, install the MIR SMART ONE free app,
which you can download from the Apple Store (for iPhone and iPad) or Play Store (for
Android devices).
Launch the MIR SMART ONE OXI app and proceed with the following steps.
These are one-off steps that do not need to be repeated each time the app is accessed.
a) authorisation for data exchange with the Health app, already installed in the smartphone.
The user can decide whether or not to allow
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• the following data to be written to the Health application: height, weight, PEF and FEV1
• the following data to be read from the Health application: height, weight, date of birth,
gender.
Authorisation for each parameter can be given or denied.
b) entering your own personal data: date of birth, origins, weight, height, gender.
The MIR SMART ONE OXI will use this data to calculate the baseline values of the PEF and
to assign a colour indicator to your test (green, yellow or red). Consult the CALCULATION OF
BASELINE VALUES section for a full detailed explanation of the baseline value. If the data is
not entered a warning message appears.
The connection between SMART ONE OXI and your smartphone is automatic. To check
whether there is a connection, read the messages from the application.
7. HOW SMART ONE OXI WORKS
SMART ONE OXI is an electronic device for domestic use which precisely measures your PEF
(Peak Expiratory Flow) and the FEV1 (maximal expiratory volume in the 1st second, VEMS).
The device also measures the parameters related to the oximetry test in particular the SpO2
and the BPM.
The PEF is the maximal expiratory volume with which the air can be expelled from the lungs
after having drawn breath in deeply, while the FEV1 is the maximal expiratory 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 MEASUREMENT OF PEF AND FEV1 AT HOME?
The first portable mechanical measuring instrument for calculating PEF was introduced by
B. Wright in 1959. The wide use made of this device for monitoring children above five years
of age and adults made this instrument popular for tracing the respiratory conditions of
patients with asthma and other pulmonary dysfunctions.
Electronic measuring instruments, economical, small, portable and easy to use for assessing
respiratory dysfunction are now widely available. These offer numerous advantages,
including the possibility of recording the PEF and FEV1, and recording and transferring the
data to a physician or another licensed healthcare professional.
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SMART ONE OXI emits a warning signal if the test is not correctly carried out, for example if
instead of blowing as much as possible exhalation is too slow. This is a further objective
advantage with respect to a mechanical spirometer which does not provide any such
signalling.
The PEF and FEV1 are measured during the same exhalation. When the test is correctly
carried out, the PEF is measured for 0.10-0.15 seconds from the start of exhalation, while
the FEV1 is measured for 1 second exactly from the start of the exhalation.
According to the best tests of effectiveness, taken from among numerous scientific studies,
research documents and expert clinicians, both the PEF and FEV1 are good indicators of the
respiratory mechanics in conditions of health and illness and can indicate how the breathing
functions and can help to verify whether there have been alterations to the respiratory flow.
The constant measurement of PEF and FEV1 provides a proof of progression of an illness.
The GUIDE FOR MANAGEMENT AND PREVENTION OF ASTHMA, published in 2016 by GINA
Global Strategy for Asthma Management and Prevention) states:
To obtain training for effective self-management of asthma the following is necessary:
• Self-monitoring of the symptoms and/or the lung function
• A written plan of action for asthma
• Periodic medical checks
The above indicates that when self-managing asthma the conditions of your lungs can
effectively be monitored on the basis of the plan of action written out by a physician or a
licensed healthcare professional.
WARNING: TO INTERPRET THE MEANING AND IMPORTANCE OF A MEASUREMENT
OBTAINED USING SMART ONE OXI AND DECIDING AN APPROPRIATE PLAN OF ACTION IT IS
NECESSARY TO CONSULT A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL.
The SMART ONE OXI connects to a smartphone via Bluetooth SMART technology.
Connection is automatic once the MIR SMART ONE OXI application has been installed on the
smartphone.
Each PEF and FEV1 measurement is transferred by the device to the smartphone so as to be
displayed. The use of the coloured PEF indicator (green, yellow or red) is recommended as
indicated by your physician or another licensed healthcare professional. These are the
professionals who will help you to accurately run the test and advise you as to the actions
to undertake when measuring decreasing values.
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WARNING: WHEN SMART ONE OXI 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 PEF and FEV1 value usually means that the air is easily accessing the lungs. When
there is an asthma attack the air can no longer easily circulate in the lungs and lower
measurements are the outcome. It is usually recommended to carry out the measurements
as indicated by the licensed healthcare professionals.
SMART ONE OXI should be used also when respiratory difficulty symptoms are manifested,
to help the person and the physician or licensed healthcare professional to determine the
severity of the respiratory symptoms and understand how the treatment is working. Consult
your physician or other licensed healthcare professional about the times and frequency of
use of the SMART ONE OXI spirometer and pulse oximeter.
7.1 Control of registrations
The MIR SMART ONE OXI app keeps a trace of the higher PEF and FEV1 values read both
for the morning and evening session, complete with date and time of reading. The points
between two readings are connected to one another to form a graph of the trend. This
recording is destined in future to become an important part of the plan of action for every
sufferer’s asthma.
The MIR SMART ONE can transfer the data measured to the family physician or another
licensed healthcare professional. If correctly used, SMART ONE OXI helps patients and
physicians or licensed health personnel to monitor asthma and other lung pathologies so as
to offer the best treatment.
The subsequent revision of the measured data enables patients and healthcare
professionals to more precisely check the respiratory complaint present in order to provide
the most suitable personalised treatment.
As the smartphone automatically memorises hundreds of readings, the device can be taken
along to a meeting with your physician or healthcare professional so that a large quantity of
readings can be viewed.
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7.2 Self-measurement of PEF and FEV1 values
BEFORE USING THIS DEVICE READ ALL INFORMATION CONTAINED IN THIS USER MANUAL. IF YOU
DO NOT UNDERSTAND THESE INSTRUCTIONS OR IF YOU HAVE QUESTIONS ABOUT YOUR
SPIROMETER AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE
PROFESSIONAL.
IF THE INSTRUCTIONS ARE NOT CLEAR:
USA:
Call MIR USA Tel + 1 (262) 565 - 6797 ; Fax + 1 (262) 364 - 2030, Monday to Friday 8 AM to 5 PM
(central time), or contact us at mirusa@spirometry.com, or write to us at MIR USA, 5462 S.
Westridge Drive, New Berlin, WI 53151 – USA.
Call MIR +39 06 22754777, Monday to Friday 8 AM to 5 PM (GMT+1), or contact us at
mir@spirometry.com, or write us at MIR Via del Maggiolino 125, 00155 Rome, Italy.
ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL TO WATCH YOU USING
THE SPIROMETER. THIS HELPS TO ENSURE CORRECT USE OF THE INSTRUMENT.
INDEPENDENTLY OF THE MEASUREMENT VALUES ON YOUR SPIROMETER, IF YOU ARE SHOWING
SIGNS AND SYMPTOMS SUCH AS THORACIC CONSTRICTION, SHORT BREATH, COUGH OR
DYSPNOEA, CONTACT AND FOLLOW THE INDICATIONS OF YOUR PHYSICIAN OR A LICENSED
HEALTHCARE PROFESSIONAL.
IF YOU CANNOT OBTAIN A VALUE, CONTACT YOUR PHYSICIAN IMMEDIATELY.
SMART ONE OXI must be cleaned as illustrated in the MAINTENANCE AND CLEANLINESS
section prior to starting to use it and then periodically.
To perform a measurement:
• Running the MIR SMART ONE app on a smartphone
• Press the START icon
• Wait for the 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 the mouthpiece at a depth of at least
0.5 cm in the turbine socket.
4
The SMART ONE is ready to use.
Hold SMART ONE OXI in your hand as
if it were a mobile telephone and
ensure that the turbine is not
obstructed by your hand.
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5
Insert the mouthpiece between your
teeth and close your lips about the
mouthpiece. Ensure that your lips grip
the mouthpiece forcefully.
To prevent turbulence that might
otherwise affect the results do not put
your tongue in the mouthpiece. Do not
bend your neck.
6
Tap the “Start Test” icon under
SPIROMETRY on the MIR SmartOne App.
6
It is best to do the test standing or sitting
upright. (it makes no difference to the
test results).
7
• Slowly inhale, taking in as much air as
possible.
• Blow with maximum force possible
until the result appears on the
smartphone screen.
• These are your PEF and FEV1 values.
N.B.: Avoid exhaling slowly and at
length
As each test must consist of three
individual tests, repeat steps from 4 to
7 twice more.
Each session lasts 5 minutes.
SMART ONE OXI will save the highest
value of the three individual tests only if
the highest in the session presently open.
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Warning: For monitoring elderly patients and children and differently-able persons, the
supervision of an adult is required.
The device shows an error message if the exhalation start-up was not satisfactory and if the
exhalation did not finish satisfactorily.
7.3 Performing the oximetry test
To perform the test correctly, follow the instructions below.
1
Place the thumb of the hand holding the
SMART ONE OXI on the sensor as in the
image
2
Tap the "Start Test" icon under OXIMETRY
on the SMART ONE application.
3
During the test the perfusion index is
reported with a bar indicator.
Minimum duration of a test is 30 seconds.
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The device displays an error message if the sensor is not functioning and if the finger is not
positioned on the sensor.
If the signal detected is not of sufficient quality to estimate the oximetry parameters; the
parameters are not displayed.
7.4 How to interpret the results
For the spirometry measurements, three individual
tests are made in each test, after which the MIR
SMART ONE app compares the values with all those
obtained in the preceding 5 minutes. For the session
PEF values it is therefore automatically selected,
saved and compared with the baseline value. The app
shows a graphic sign (green, yellow or red) which is
then displayed as a coloured circle about the PEF
value obtained.
The meaning of the traffic lights is displayed in the
following table.
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COLOUR
RESULT
MEANING
ACTION
Green
Above 80% of the
baseline
OK
Respiratory conditions seem to be
under control. The treatment is
working. Process with normal
activities.
Yellow
Above 50% and below
or identical to 80% of
the baseline
Warning
Caution in carrying out the
operations Refer to the plan of
action set out by your physician or
by a licensed healthcare
professional to establish which
action is to be undertaken.
Red
Below or identical to
50% of the baseline
Danger
Medical alert. Seek immediate
medical help. Act as agreed with
your physician or other licensed
healthcare professional.
For the oximetry measurements, each test saved in the memory appears in the
Results section, which contains the value of SpO2, the value of cardiac frequency, the
date and time of the test and any notes.
WARNING: ASK YOUR PHYSICIAN OR LICENSED HEALTHCARE PROFESSIONAL TO WATCH
YOU USING THE SMART ONE OXI BEFORE RELYING ON ANY MEASUREMENT.
WARNING: 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.
WARNING: THE PLAN OF ACTION PROVIDED BY YOUR PHYSICIAN OR OTHER LICENSED
HEALTHCARE PROFESSIONAL WILL INDICATE WHICH ACTION TO TAKE IN A CASE IN WHICH
THERE ARE RELEVANT VARIATIONS IN VALUES.
WARNING: INDEPENDENTLY OF YOUR VALUES, AND EVEN WHERE THE DEVICE IS NOT
INDICATING ALARMS, IF YOU ARE SHOWING SIGNS AND SYMPTOMS SUCH AS THORACIC
CONSTRICTION, SHORT BREATH, COUGH OR DYSPNOEA, CONTACT YOUR PHYSICIAN OR
LICENSED HEALTHCARE PROFESSIONAL.
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8. 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.
For monitoring elderly patients and children above 5 years of age, and differentlyable persons, the supervision of an adult is required.
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 that no impurities or foreign bodies, such as skin or hairs, have accumulated
inside the turbine. Any modifications not expressly approved by this Company could
compromise use of the device by the user.
Check that there are no elements obstructing the oximetry sensor. Any
modifications not expressly approved by this Company could compromise use of the
device by the user.
Do not let the device fall and do not treat it with lack of care. Avoid strong vibrations.
The device is not designed to be used in direct air currents (e.g. wind), sources of
heat or cold, direct sun rays or other sources of light or energy, dust, sand or
chemical substances.
Use and store the device in compliance with the environmental conditions specified
in the Technical Specifications. If the device is exposed to environmental conditions
other than those specified, it might 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. If problems arise, do not try to repair the
device yourself.
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8.1 Data security warnings
The smartphone stores the user’s 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 of 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
• Check that the email address you are to send your test results to is the correct one
• After transmitting the data call your physician to confirm that it has been received
8.2 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. This electromagnetic interference could cause the medical device to
malfunction, such as an accuracy of measurement that is lower than the declared one, and
create a potentially unsafe situation.
SMART ONE OXI complies with EN 60601-1-2:2015 on electromagnetic compatibility (EMC
for electro-medical devices) for both immunity and emissions.
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For the device to function properly, however, the following precautions must be taken:
• Make sure that the SMART ONE OXI and the smartphone on which the app is installed
are no more than 2 metres apart.
• Do not use SMART ONE OXI near other devices (computers, cordless phones, cell
phones, etc.) that generate strong electromagnetic fields. Keep the above-described
equipment at a distance of at least 30 centimetres. If a use under lower distances is
necessary, SMART ONE OXI and the other devices should be kept under observation to
verify that they are functioning normally.
8.3 Notes on FCC certification
SMART ONE OXI complies with Part 15 of the FCC Standards. Operation is subject to the
following conditions:
(1) this device cannot cause harmful interference
(2) this device must accept interference in reception, including the interference that might
cause an undesired functioning.
Any modifications not expressly authorised by this company might compromise the use of
the device by the user.
N.B.: This equipment has been tested and conforms to the limits for Class B digital devices
in accordance with Part 15 of the FCC Standards. These limits are conceived to provide
reasonable protection from damaging interferences when the equipment is used in a
residential context. 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. It is not however possible to guarantee that these
interferences will not occur. The device causes interference with the reception of radio or
tv signals, which can arise by switching the device on or off; the user is advised to try to
correct the interference by taking one of the following steps:
• Reorienting or relocating the antenna
• Increasing the distance between the equipment and the receiver
• Connecting the equipment to a socket on a different circuit from the one the receiver
is connected to
• Consulting the dealer and/or an radio/tv expert technician.
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9. MAINTENANCE AND CLEANLINESS
SMART ONE OXI is a device that requires little maintenance. The following operations must
be carried out regularly:
• cleaning of the reusable turbine
• cleaning of the mouthpiece
• Replacing the FlowMir® turbine
• cleaning of the device
• replacing batteries
At each patient change, the reusable turbine must be cleaned if it is used instead of the
FlowMir® turbine.
9.1 Cleaning of the reusable turbine
The following instructions only apply if the reusable single-patient turbine is used. If the
FlowMir® is used, replace it after each session.
To avoid irreparable damage to the turbine, do not use detergents including alcohol or
oily substances and do not immerse the turbine in water or solutions at high
temperatures. Never try to sterilise the turbine in boiling water. Never try to clean the
turbine under a direct jet of water or other liquids. If you do not have liquid detergents
available, the turbine must be washed at least with clean water.
Correct functioning of the turbine is guaranteed only if it is “clean” and free of foreign bodies
which interfere with its movement. The presence of dust or foreign bodies (such as hairs,
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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, follow the steps below:
1) Remove the turbine from its housing by
turning anti-clockwise and apply light
pressure with your fingers from the bottom
of the turbine to lift it out of its housing.
2) Mix ¾ cup of Clorox™ bleach (7.5%) in a
quart of water. Place the orange turbine in
the solution.
3) Shake the turbine to remove all impurities
for at least 1 minute.
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4) Let the turbine soak for 15 minutes.
5) Clean the turbine by immersing it in clean
(not hot) water for at least 1 minute.
6) Remove excess water from the turbine by
shaking it and let it dry by placing it
vertically on a dry surface
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7) Check that it is clean and free of any foreign
bodies.
8) Dry it with a cloth.
After cleaning, insert the turbine into the
socket in the direction indicated by the
closed padlock symbol screen-printed on
the SMART ONE OXI device. To insert the
turbine correctly, push it down and turn it
clockwise until it stops, to make sure it is
fully inserted into the plastic housing.
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9.2 Cleaning of the mouthpiece
Be sure to clean the mouthpiece after each use, as outlined in the instructions below.
1) To clean the nozzle, simply remove it from
the turbine.
2) Immerse the mouthpiece in warm water.
3) Shake the mouthpiece for 2-3 minutes.
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4) Rinse it in clean water.
5) Shake it gently to remove any excess water.
6) Let it dry on a cloth.
Afterwards, insert the mouthpiece into the
turbine with gentle pressure.
9.3 Cleaning of the device
Clean the device once a day using a clean damp cloth. 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
Do not use alcoholic solutions.
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9.4 Replacing batteries
The device continuously monitors the battery level. A message on the smartphone display
alerts the user when the device battery is low. When the batteries are completely charged
the device has an operational span of five years or 1000 tests, whichever comes first.
Used SMART ONE OXI batteries should only be disposed of in special containers or
preferably returned to the distributor dealer of the device or to a special collection
centre. In any case, all applicable local regulations must be complied with.
1
Remove the battery cover on the back
of the SMART ONE OXI.
2
Remove the two batteries and replace
them with two new ones, following the
polarity as indicated by the symbols in
the compartment.
3
Reposition the battery cover.
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10. ERROR MESSAGES
If you encounter any problems when using the SMART ONE OXI, a message will appear on
the smartphone display to warn of the malfunction.
MESSAGE
Storage conditions
SOLUTION
Bluetooth
Bluetooth is deactivated
To perform measurements with the
device, you must activate Bluetooth
on the smartphone. Exit the app and
activate the Bluetooth from the
smartphone settings menu.
Battery low
When the SMART ONE OXI
batteries are below 15%
Replace the SMART ONE OXI
batteries
It appears that no
email account has
been configured.
The user wants to share
the results of the tests, but
has not configured an email account on their
smartphone.
Set an email account from the
smartphone settings menu.
The oximetry test
has not been stored
The test lasted less than 30
seconds or the average
value of the finger
pressure was unsatisfactory
Repeat the test following the
instructions given on the display and
wait at least 30 seconds for the test
to complete. The test lasts a
maximum of 60 seconds after which
it is automatically interrupted
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11. TROUBLESHOOTING
If you have an unusually low reading, it could mean that your SMART ONE OXI flowmeter is
broken, or it could mean that the reading is accurate and your asthma is getting worse.
Check that the flowmeter is not broken. Scrupulously follow the instructions to obtain
accurate results. If the flowmeter is not broken, follow the instructions in your plan of action
relating to low readings and consult your physician or another licensed healthcare
professional.
For any question relating to the use of the device, contact your physician or other licensed
healthcare professional, or contact MIR USA, Inc.
Freephone no: 844–464–7872.
USA:
Call MIR USA 1-844-464-7872, Monday to Friday 8 AM to 5 PM (central time), or contact us
at mirusa@spirometry.com, or write us at MIR USA, 5462 S. Westridge Drive New Berlin, WI
53151 - USA
EUROPE and WORLDWIDE:
Call MIR +39 06 22754777, from Monday to Friday, from 8 am to 5 pm (GMT+1), or contact
us at mir@spirometry.com, or write TO us at MIR Via del Maggiolino 125, 00155 Roma, Italy.
If problems occur when using the device, the following points should be checked.
MALFUNCTIONING
Storage conditions
SOLUTION
SMART ONE OXI cannot
connect with the
smartphone
The Bluetooth connection
is not working properly
Look for SMART ONE OXI 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
Clean the turbine as described in the
Maintenance section. If necessary,
replace the turbine with a new one. If
necessary contact the manufacturer.
The test was performed
wrongly
Repeat the test, following the
directions on the screen. Avoid sudden
movements when you finish
exhalation. Speak to your physician
about the measured values
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MALFUNCTIONING
Storage conditions
SOLUTION
The turbine has not been
inserted properly
Insert the turbine from the front part
of the device by pushing it downwards
until it stops, and then rotating it in a
clockwise direction
The oximetry test has
not been stored
The test lasted less than
30 seconds or the
average value of the
finger pressure was
unsatisfactory
Repeat the test following the
instructions given on the display and
wait at least 30 seconds for the test to
complete.
12. ACCURACY AND RELIABILITY
For the spirometry measurements, the device complies with the requisites of the following
standards:
Standardisation of the spirometry (ATS 2005, 2019 update)
ISO 23747: 2015
ISO 26782: 2009
Volume max 10 I
Volume accuracy: the higher value between 2.5% and 0.05 l (ATS 2019)
Max. peak flow 960 l/min (16 l/s)
Peak flow accuracy: highest value between 10% and 20 l/min (0.33 l/s)
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 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 the following equation:
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Time zero = t
PEF
- (V
PEF
/PEF)
Where
PEF is the peak expiratory flow;
t
PEF
is the elapsed time at PEF;
V
PEF
is the expired volume at PEF
For the oximetry measurements, the device conforms to the requisites of the following
standard:
ISO 80601-2-61:2017 Medical electrical equipment – particular requirements for basic safety
and essential performance of pulse oximeter equipment
Range (SpO2)
Arms (%)
70-100 %
± 1.90
70-80 %
± 2.32
80-90 %
± 1.71
90-100 %
± 1.43
The Arms (Accuracy Root Mean Square), as mentioned in the above-cited standard,
represents the accuracy of the device in terms of mean quadratic error of each SpO2
measurement, obtained by pulse oximetry, in relation to the respective reference value of
SaO2, obtained by co-oximetry.
The listed ranges show the different saturation intervals of oxygen for which the accuracy
has been calculated.
The accuracy of the device cannot be assessed with a tester.
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13. LABELS & SYMBOLS
The symbols are described in the table below
SYMBOL
DESCRIPTION
Model:
Description of product
SN
Series number of the device
Manufacturer’s name and address
0476
The product is a certified Class IIa medical device and meets the requirements of
Regulation (EU) 2017/745 for medical devices.
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 2012/19/EU 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 for collection of waste from electrical and electronic
equipment. 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 arranged at up to 15° from the vertical.
The symbol is used to identify products containing RF transmitters.
FCC ID
Identification showing traceability in compliance with FCC Standards
Instructions for use symbol. Read this manual carefully before using the medical
device
Production date
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SYMBOL
DESCRIPTION
Temperature limits: indicates the temperature limits to which the medical device
can be safely exposed
Humidity limitation: indicates the range of humidity to which the medical device
can be safely exposed
The symbol indicates that the product is a medical device
The symbol indicates the Unique Device Identification
SMART ONE OXI complies with the Basic Requirements of Regulation (EU) 2017/745 for
medical devices.
14. TECHNICAL SPECIFICATIONS
Peak Expiratory Flow
PEF (l/min)
Maximum Expiratory Volume in 1st
second
FEV1 (l)
Mean saturation percentage of
oxygen in the blood during the test
SpO2 (%)
Average heart rate during the test
BPM (heartbeats per minute)
Measuring system
Bi-directional turbine (rotary blade)
Spirometry principle of
measurement
Infrared interruption
Oximetry principle of
measurement
Reflective LED sensor, with double wavelength
Max. peak flow
PEF 960 l/min (16 l/s)
Volume max
FEV1 10l
Volume accuracy (ATS 2019)
The greater value between 2.5% and 0.05 l
Peak flow accuracy
The greater value between 10% and 20 l/min
( 0.33 l/s)
Dynamic resistance at 12 L/s
<0.5 cm H2O/L/s
SpO2 measurement range
70%-100%
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SpO2 accuracy
1.9%
Cardiac frequency measurement
range
30-200 BPM
BPM accuracy
3%
Communication interface
Bluetooth SMART (4.0 or higher)
Electrical power supply
2 x 1.5V AAA alkaline batteries
Measurements
Main body 109x49x21 mm
Weight
60.7 g (including batteries)
Type of electrical protection
Internal power supply
Level of electrical protection
BF type part applied
IP protection level
IP22
Applicable standard
ATS/ERS Guidelines: 2005, 2019 update
ISO 26782: 2009
ISO 23747: 2015
EN ISO 14971: 2019
ISO 10993-1: 2018
2011/65/UE Directive
EN ISO 15223-1:2021
IEC 60601-1:2005 + A1: 2012
EN 60601-1-2: 2015
EN IEC 60601-1-6: 2010+Amd2013
EN 60601-1-11: 2015
ISO 80601-2-61: 2017
IEC 62304:2006/A1:2015
Directive 2014-53-EU-RED
Conditions of use
Device for continuous use
Conservation conditions
Temperature: MIN -25°C, MAX +70°C
Humidity: MIN 10% UR; MAX 93% UR
Transport conditions
Temperature: MIN -25°C, MAX +70°C
Humidity: MIN 10% UR; MAX 93% UR
Operating conditions
Temperature: MIN +5 °C, MAX +40 °C
Humidity: MIN 15% UR; MAX 93% UR
LED sensor wavelengths
Red light: 660 nm**
Infrared light: 880 nm**
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Mean maximum optical power in
output
1.2 mW
** This information can be useful for the physician.
Warning: Life time - the expected life time (or service life) of the device if properly used
and stored is 5 years.
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15. INFORMATION ON BLUETOOTH WIRELESS TECHNOLOGY
Bluetooth compliance:
Bluetooth 5-Ready
Operating Frequency:
from 2.4 GHz to 2.4835 GHz
Max Output Power:
TX: 0 dBm; 1 mW
Operating Range:
radius of 10 metres (range of vision)
Network Topology:
Star - bus
Operation:
Server
Antenna type:
Antenna integrated in the module
Modulation Technology:
FHSS
Modulation Type:
GFSK
Data Rate:
1 Mbit/second
Data latency:
7 – 40 ms
Data Integrity:
Adaptive frequency hop, Lazy Acknowledgement, CRC at 24
bit, message integrity check at 32-bit
Format:
Sending data packages every 60 ms. It includes 3 control
bytes to enable the host to detect any missing packages and
the device to re-transmit them.
Quality of Service:
This device uses Bluetooth Smart technology for wireless
communications, so as to provide reliable communication in
electrically noisy environments and transmit data packages
every 60 ms.
It includes 3 control bytes to enable the host to detect any
missing packages and the device to re-transmit them. In the
event of the connection being interrupted, the app changes
status, from connected to not-connected, and becomes
immediately available for a connection.
Bluetooth Profiles
supported:
Profile based on GATT
Authentication and
Encryption:
Supported
Encryption Key Size:
AES 128 bit with Counter Mode CBC-MAC and application
level defined by the user
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
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15.1 Communication at radiofrequency (RF)
This device conforms to the FCC standards (United States Federal Communications
Commission) and to the international standards on electromagnetic compatibility. The
following information is provided in accordance with the FCC (Federal Communications
Commission) rules.
The device complies to Part 15 of the FCC Standards. Operation is subject to the following
conditions: (1) This device must not cause damaging interference and (2) this device must
accept any interference received, including the interference which might cause an undesired
functioning.
The device does not interfere with the radiofrequency signals transmitted from external
sources. The FCC standards were conceived to provide reasonable protection against
excessive radiofrequency interference and to prevent malfunctioning of the device caused
by undesired electromagnetic interference.
15.2 Interference in radiofrequency (RF) caused by other wireless devices
The majority of consumer electronic devices on the same frequency band as used by
SmartOne can prevent the uploader or the mobile device from receiving the data.
This equipment has been tested and conforms to the limits for Class B digital devices in
accordance with Part 15 of the FCC Standards. These limits are conceived to provide
reasonable protection from damaging interferences in a residential context. 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.
It is not however possible to guarantee that these interferences will not occur in a particular
installation. The device causes damaging interference with the reception of radio or tv
signals, which can arise by switching the equipment on or off; the user is advised to try to
correct the interference by increasing the distance separating the equipment from the
receiver.
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16. WARRANTY TERMS
SMART ONE OXI is guaranteed for a period of 12 months in the case of professional use
(physician, hospital, etc.) or 24 months for other use. The warranty period is effective from
the date of purchase, which must be proven by an invoice or sales receipt. The device must
be checked at the time of purchase, or upon delivery, and any claims must be made
immediately in writing to the manufacturer.
This warranty covers the repair or the replacement (at the discretion of the manufacturer)
of the product or of the defective parts without charge for the parts or for the labour. All
batteries and other consumable parts, including the turbine flow meter, are specifically
excluded from the terms of this guarantee.
The product warranty shall not apply, at the discretion of the manufacturer, in the following cases:
• Improper handling, improper installation, improper operation of the device, or if the
installation does not comply with local technical or safety regulations
• Use of the product for purposes other than those provided or failure to follow
instructions
• Repair, adaptation, modification or tampering by third party
• Damage caused by lack of or incorrect maintenance
• Damage caused by abnormal physical or electrical stress, or by leaking batteries
• Serial number altered, deleted, removed or rendered illegible
The repair or replacement described in this warranty is provided for goods returned at the
customers' expense to certified service centres authorized by manufacturer. For details of
these centres please contact either your local supplier or the manufacturer. Any
unauthorized opening of the device invalidates all guarantee claims.
Customer shall be responsible for all transport, customs and delivery charges regarding the
goods. Each product, or accessory, sent in for repair must be accompanied by a clear and
detailed explanation of the fault. Forwarding to the manufacturer requires the written
permission of the manufacturer himself.
The manufacturer (MIR - MEDICAL INTERNATIONAL RESEARCH S.p.A.) reserves the right
to replace the product or make any changes deemed necessary.
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