MIR Smart One Oxi User Manual
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MIR Smart One Oxi User Manual

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Smart One Oxi
English
Oxi ®
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),
mirusa@spirometry.com
or contact us at
, or write to us at MIR USA, 5462 S. Westridge Drive, New Berlin,
.
WI 53151 – USA
EUROPE and WORLDWIDE:
mir@spirometry.com
Call MIR +39 06 22754777, Monday to Friday 8 AM to 5 PM (GMT+1), or contact us at
,
or write to us at MIR Via del Maggiolino 125, 00155 Rome, Italy.
User Manual Rev 1.8
Issue Date February 04
th
, 2022
0476
is registered trademark of MIR S.r.l. MEDICAL INTERNATIONAL RESEARCH
Oxi
User Manual
Page 1 of 35
Rev.1.8

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  • Page 1 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), mirusa@spirometry.com or contact us at , or write to us at MIR USA, 5462 S.
  • Page 2 Smart One Oxi English Measurements Date Recommendation Doctor FEV1 Reserved for the physician or other licensed healthcare professional to write your positive flow rates and to provide specific interventions he/she recommends for ranges of decreased flow rates. User Manual Page 2 of 35...

  • Page 3: Table Of Contents

    ......... 5 DETERMINING YOUR PEF BASELINE VALUES..............6 WARNINGS AND PRECAUTIONS ................... 8 HOW TO START TO USE THE MIR SMART ONE APP ............. 9 HOW SMART ONE OXI WORKS .................. 10 Control of registrations ..................12 Self-measurement of PEF and FEV1 values ............13 Performing the oximetry test ................
  • Page 4 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.

  • Page 5: Indications For Use

    English 1. INDICATIONS FOR 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.

  • Page 6: Determining Your Pef Baseline Values

    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.
  • Page 7 Smart One Oxi English PEF table Male (L/min) Height (cm) Female PEF values (l/min) Height (cm) User Manual Page 7 of 35 Rev.1.8...

  • Page 8: Warnings And Precautions

    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.

  • Page 9: 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).

  • Page 10: How Smart One Oxi Works

    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.
  • Page 11 Smart One Oxi English 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.

  • Page 12: Control Of Registrations

    SMART ONE OXI spirometer and pulse oximeter. 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.

  • Page 13: Self-Measurement Of Pef And Fev1 Values

    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.
  • Page 14 Insert the mouthpiece at a depth of at least The SMART ONE is ready to use. 0.5 cm in the turbine socket. 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.
  • Page 15 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. User Manual Page 15 of 35 Rev.1.8...

  • Page 16: 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 During the test the perfusion index is reported with a bar indicator.

  • Page 17: How To Interpret The Results

    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.
  • Page 18 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.

  • Page 19: Important Safety Warnings

    Smart One Oxi English 7. 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 differently- able persons, the supervision of an adult is required.

  • Page 20: Data Security Warnings

    SMART ONE OXI complies with EN 60601-1-2:2015 on electromagnetic compatibility (EMC for electro-medical devices) for both immunity and emissions. User Manual Page 20 of 35 Rev.1.8...

  • Page 21: Notes On Fcc Certification

    English 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.

  • Page 22: Maintenance And Cleanliness

    Smart One Oxi English 8. MAINTENANCE AND CLEANLINESS SMART ONE OXI is a device that requires little maintenance. The following operations must be carried out regularly: • cleaning and disinfection of the turbine • cleaning and disinfection of the mouthpiece •...

  • Page 23: Cleaning And Disinfection Of The Mouthpiece

    Smart One Oxi English To clean the turbine, pull it out of the SMART ONE OXI socket by turning it counterclockwise and simply pulling it out. To make it easier to pull out, push the base of the turbine gently with a finger.

  • Page 24: Error Messages

    Reposition the battery cover. 9. 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. User Manual Page 24 of 35...
  • Page 25 To perform measurements with the device, you must activate Bluetooth on the smartphone. Exit the app and activate the Bluetooth from the smartphone settings menu. Battery low When the SMART ONE OXI Replace SMART ONE batteries are below 15% batteries It appears that no...

  • Page 26: Troubleshooting

    English 10. 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.

  • Page 27: Accuracy And Reliability

    Smart One Oxi English MALFUNCTIONING Storage conditions SOLUTION The turbine has not been Insert the turbine from the front part inserted properly of the device by pushing it downwards until it stops, and then rotating it in a clockwise direction...
  • Page 28 Smart One Oxi English Time zero = t - (V /PEF) Where PEF is the peak expiratory flow; is the elapsed time at PEF; is the expired volume at PEF For the oximetry measurements, the device conforms to the requisites of the following standard: ISO 80601-2-61:2017 Medical electrical equipment –...

  • Page 29: Labels & Symbols

    Smart One Oxi English 12. LABELS & SYMBOLS The symbols are described in the table below SYMBOL DESCRIPTION Model: Description of product Series number of the device Manufacturer’s name and address This product is a certified Class IIa medical device, and complies with the requirements of Directive 93/42/EEC.

  • Page 30: Technical Specifications

    Pressure limitation: indicates the range of pressure to which the medical device can be safely exposed SMART ONE OXI complies with the Essential Requirements of Directive 93/42/EEC on Medical Devices. This is based on CE Certificate no. MED 9826 issued by Kiwa Cermet, notified Organism no.
  • Page 31 Smart One Oxi English 1.9% SpO2 accuracy Cardiac frequency measurement 30-200 BPM range 3% BPM accuracy Communication interface Bluetooth SMART (4.0 or higher) Electrical power supply 2 x 1.5V AAA alkaline batteries Measurements Main body 109x49x21 mm Weight 60.7 g (including batteries)
  • Page 32 Smart One Oxi English 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.

  • Page 33: Information On Bluetooth Wireless Technology

    Smart One Oxi English 14. 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:...

  • Page 34: Communication At Radiofrequency (Rf)

    Smart One Oxi English 14.1 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.

  • Page 35: Warranty Terms

    English 15. 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.

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