MIR Oxi Smart One Wireless Spirometer and Oximeter User Guide

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:

1. 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).

2. 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.

3. 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.

4. 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.

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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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Smart One Oxi
English
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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Smart One Oxi
English
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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Smart One Oxi
English
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

Smart One Oxi
English

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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English
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:

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 CloroxTM 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.

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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.

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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.

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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.

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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References

• Advanced Encryption Standard - Wikipedia
• CCM mode - Wikipedia

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