MIR Oxi Smart One Wireless Spirometer and Oximeter User Guide
- June 13, 2024
- MIR
Table of Contents
Oxi Smart One Wireless Spirometer and Oximeter
Product Information:
Product Name: Smart One Oxi
Manufacturer: MIR – MEDICAL INTERNATIONAL
RESEARCH S.P.A.
Model: Oxi
Trademark: Registered trademark of MIR –
MEDICAL INTERNATIONAL RESEARCH S.P.A.
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.
Product Usage Instructions:
-
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. -
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. -
When using SMART ONE OXI to monitor lung conditions such as
asthma, you should be under the care of a physician or other
licensed healthcare professional.
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.
Contact Information:
-
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. -
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.
Note: The manufacturer cannot be held
responsible for any damage caused by users failing to follow the
instructions contained in this manual.
Smart One Oxi
English
Oxi ®
English (EN)
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.
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.
Rev.2.0.1
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Date
Measurements
PEF
FEV1
Smart One Oxi
English
Recommendation
Doctor
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.
INCLUDES
Spirometer for peak flow and FEV1
Plastic mouthpiece
2 AAA batteries
User Manual
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 Website: www.spirometry.com
Fax + 1 (262) 364 2030 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.
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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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AG E
AG E
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PEF table Male (L/min) Height (cm)
120 130 140 150 160 170 180 190 200 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 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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Push the turbine into the slot until it stops
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Turn the turbine clockwise until it stops
1
2
Insert the mouthpiece at a depth of at least 0.5 cm in the turbine socket.
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.
3
4
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Insert the mouthpiece between your teeth and close your lips about the mouthpiece. Ensure that your lips grip the mouthpiece forcefully.
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Tap the “Start Test” icon under SPIROMETRY on the MIR SmartOne App.
5
6
To prevent turbulence that might otherwise affect the results do not put your tongue in the mouthpiece. Do not bend your neck.
It is best to do the test standing or sitting upright. (it makes no difference to the test results).
· 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
6
7 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.
Place the thumb of the hand holding the Tap the “Start Test” icon under
OXIMETRY SMART ONE OXI on the sensor as in the on the SMART ONE application.
image
1
2
During the test the perfusion index is reported with a bar indicator. Minimum
duration of a test is 30 seconds.
3
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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 Green
RESULT
MEANING
Above 80% of the OK
baseline
Yellow
Above 50% and below Warning or identical to 80% of the baseline
Red
Below or identical to Danger
50% of the baseline
ACTION Respiratory conditions seem to be under control. The treatment is working. Process with normal activities. 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. 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:
-
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.
-
Mix ¾ cup of CloroxTM bleach (7.5%) in a quart of water. Place the orange turbine in
the solution. -
Shake the turbine to remove all impurities for at least 1 minute.
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- Let the turbine soak for 15 minutes.
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- Clean the turbine by immersing it in clean (not hot) water for at least 1 minute.
- 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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- Check that it is clean and free of any foreign bodies.
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- 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.
- To clean the nozzle, simply remove it from the turbine.
- Immerse the mouthpiece in warm water.
- Shake the mouthpiece for 2-3 minutes.
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- Rinse it in clean water.
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-
Shake it gently to remove any excess water.
-
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.
Remove the battery cover on the back of the SMART ONE OXI.
Remove the two batteries and replace them with two new ones, following the polarity as indicated by the symbols in the compartment.
1
2
Reposition the battery cover. 3
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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 Bluetooth
Battery low It appears that no email account has been configured.
The oximetry test has not been stored
Storage conditions Bluetooth is deactivated
When the SMART ONE OXI batteries are below 15% The user wants to share the
results of the tests, but has not configured an email account on their
smartphone. The test lasted less than 30 seconds or the average value of the
finger pressure was unsatisfactory
SOLUTION 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. Replace the SMART ONE OXI batteries Set an email account from
the smartphone settings menu.
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:
8444647872. 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 SMART ONE OXI cannot connect with the smartphone
The test results are unreliable
Storage conditions The Bluetooth connection is not working properly
The turbine may be dirty
The test was performed wrongly
SOLUTION Look for SMART ONE OXI on the list of recognized devices. For correct use, the smartphone needs Bluetooth version 4.0 or higher Clean the turbine as described in the Maintenance section. If necessary, replace the turbine with a new one. If necessary contact the manufacturer. 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
The oximetry test has not been stored
Storage conditions The turbine has not been inserted properly
The test lasted less than 30 seconds or the average value of the finger
pressure was unsatisfactory
SOLUTION 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 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 Volume accuracy: the higher value between Max. peak flow Peak flow accuracy: highest value between
10 I 2.5% and 0.05 l (ATS 2019) 960 l/min (16 l/s) 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 = tPEF – (VPEF/PEF) Where PEF is the peak expiratory flow; tPEF is
the elapsed time at PEF; VPEF 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)
70-100 % 70-80 % 80-90 % 90-100 %
Arms (%)
± 1.90 ± 2.32
± 1.71
± 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
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The symbols are described in the table below
SYMBOL Model: SN 0476
IP22
DESCRIPTION Description of product Series number of the device
Manufacturer’s name and address 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 606011 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. 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 Maximum Expiratory Volume in 1st second Mean saturation
percentage of oxygen in the blood during the test Average heart rate during
the test Measuring system Spirometry principle of measurement Oximetry
principle of measurement Max. peak flow Volume max Volume accuracy (ATS 2019)
Peak flow accuracy
Dynamic resistance at 12 L/s SpO2 measurement range
PEF (l/min) FEV1 (l)
SpO2 (%)
BPM (heartbeats per minute) Bi-directional turbine (rotary blade) Infrared
interruption
Reflective LED sensor, with double wavelength
PEF 960 l/min (16 l/s) FEV1 10l The greater value between 2.5% and 0.05 l The
greater value between 10% and 20 l/min ( 0.33 l/s) <0.5 cm H2O/L/s 70%-100%
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SpO2 accuracy Cardiac frequency measurement range BPM accuracy Communication
interface Electrical power supply Measurements Weight Type of electrical
protection Level of electrical protection IP protection level Applicable
standard
Conditions of use Conservation conditions Transport conditions Operating
conditions LED sensor wavelengths
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1.9% 30-200 BPM
3% Bluetooth SMART (4.0 or higher) 2 x 1.5V AAA alkaline batteries Main body 109x49x21 mm 60.7 g (including batteries) Internal power supply BF type part applied IP22 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 Device for continuous use Temperature: MIN -25°C, MAX +70°C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN -25°C, MAX +70°C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN +5 °C, MAX +40 °C Humidity: MIN 15% UR; MAX 93% UR Red light: 660 nm Infrared light: 880 nm
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Mean maximum optical power in 1.2 mW output ** 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
Profile based on GATT
supported:
Authentication and
Supported
Encryption:
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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