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Smart One Oxi

English

Rev.1.8

User Manual

Page 1 of 35

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),
or contact us at

[email protected]

, 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

[email protected]

,

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

Oxi

is registered trademark of MIR S.r.l. MEDICAL INTERNATIONAL RESEARCH

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Summary of Contents for Smart One Oxi

Page 1: ...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...

Page 2: ...of 35 Date Measurements Recommendation Doctor PEF FEV1 Reserved for the physician or other licensed healthcare professional to write your positive flow rates and to provide specific interventions he s...

Page 3: ...T SAFETY WARNINGS 19 7 1 Data security warnings 20 7 2 Warnings for use in electromagnetic environments 20 7 3 Notes on FCC certification 21 8 MAINTENANCE AND CLEANLINESS 22 8 1 Cleaning and disinfect...

Page 4: ...he 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...

Page 5: ...LTHCARE 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 lun...

Page 6: ...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...

Page 7: ...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...

Page 8: ...NS 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 DECI...

Page 9: ...THPIECE 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 S...

Page 10: ...ow 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 expirato...

Page 11: ...A 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 sym...

Page 12: ...ometer and pulse oximeter 6 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 ti...

Page 13: ...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 SPIROM...

Page 14: ...ntil it stops 2 Turn the turbine clockwise until it stops 3 Insert the mouthpiece at a depth of at least 0 5 cm in the turbine socket 4 The SMART ONE is ready to use Hold SMART ONE OXI in your hand as...

Page 15: ...n the MIR SmartOne App 6 It is best to do the test standing or sitting upright it makes no difference to the test results 7 Slowly inhale taking in as much air as possible Blow with maximum force poss...

Page 16: ...up was not satisfactory and if the exhalation did not finish satisfactorily 6 3 Performing the oximetry test To perform the test correctly follow the instructions below 1 Place the thumb of the hand h...

Page 17: ...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 min...

Page 18: ...ed 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 HEALT...

Page 19: ...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...

Page 20: ...ents 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...

Page 21: ...proved by the party responsible for compliance could void the user s authority to operate the equipment NOTE This equipment has been tested and found to comply with the limits for a Class B digital de...

Page 22: ...nts 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 un...

Page 23: ...until it stops to make sure it is fully inserted into the plastic housing 8 2 Cleaning and disinfection of the mouthpiece Make sure to clean the mouthpiece after each use To clean the mouthpiece simp...

Page 24: ...y case all applicable local regulations must be complied with 1 Remove the battery cover on the back of the SMART ONE OXI 2 Remove the two batteries and replace them with two new ones following the po...

Page 25: ...I batteries It appears that no email account has been configured The user wants to share the results of the tests but has not configured an e mail account on their smartphone Set an email account from...

Page 26: ...ry 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...

Page 27: ...LIABILITY 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...

Page 28: ...y and essential performance of pulse oximeter equipment Range SpO2 Arms 70 100 1 90 70 80 2 32 80 90 1 71 90 100 1 43 The Arms Accuracy Root Mean Square as mentioned in the above cited standard repres...

Page 29: ...tic 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 char...

Page 30: ...Kiwa Cermet notified Organism no 0476 13 TECHNICAL SPECIFICATIONS Peak Expiratory Flow PEF l min Maximum Expiratory Volume in 1st second FEV1 l Mean saturation percentage of oxygen in the blood durin...

Page 31: ...Applicable standard ATS ERS Guidelines 2005 2019 update ISO 26782 2009 ISO 23747 2015 EN ISO 14971 2019 ISO 10993 1 2018 2011 65 UE Directive EN ISO 15223 2016 IEC 60601 1 2005 A1 2012 EN 60601 1 2 2...

Page 32: ...User Manual Page 32 of 35 Mean maximum optical power in output 1 2 mW This information can be useful for the physician Warning Life time the expected life time or service life of the device if proper...

Page 33: ...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...

Page 34: ...caused by undesired electromagnetic interference 14 2 Interference in radiofrequency RF caused by other wireless devices The majority of consumer electronic devices on the same frequency band as used...

Page 35: ...t 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 par...

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