MIR SMARTONE User Manual
  1. Manuals
  2. Brands
  3. MIR Manuals
  4. Measuring Instruments
  5. SMARTONE
  6. User manual

MIR SMARTONE User Manual

Peak flow and fev1 meter
Hide thumbs Also See for SMARTONE:

Advertisement

Table of Contents

Smart One
®
PEAK FLOW AND FEV1 METER
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 PEAK FLOW AND FEV1 METER
AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
User Manual Rev 2.9
Issue Date October 03, 2017
0476
is registered trademark of MIR S.r.l. MEDICAL INTERNATIONAL RESEARCH
Rev.2.9
User Manual
Page 1 of 33

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the SMARTONE and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for MIR SMARTONE

Summary of Contents for MIR SMARTONE

  • Page 1 UNDERSTAND THESE INSTRUCTIONS OR IF YOU HAVE QUESTIONS ABOUT YOUR PEAK FLOW AND FEV1 METER AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. User Manual Rev 2.9 Issue Date October 03, 2017 0476 is registered trademark of MIR S.r.l. MEDICAL INTERNATIONAL RESEARCH Rev.2.9 User Manual Page 1 of 33...
  • Page 2 Smart One Measurements Date Recommendation Physician FEV1 Reserved for the physician or other licensed health care professional to write your good flow rates and to provide specific interventions he/she recommends for ranges of decreased flow rates. Rev.2.9 User Manual Page 2 of 33...
  • Page 3 ..........5 DETERMINING YOUR PEF OR FEV1 BASELINE VALUE ............6 WARNINGS AND PRECAUTIONS ..................8 HOW TO START USING THE MIR SMART ONE APP ............9 HOW SMART ONE WORKS .................... 10 Diary record ......................12 Self–measuring of PEF or FEV1 value ..............13 Interpreting results .....................
  • Page 4 Smart One Before connecting SMART ONE 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 there is, do not use the device and send it straight back for replacement.
  • Page 5 Smart One 1. IMPORTANT INFORMATION CONCERNING INTENDED USE Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second). The device is designed for children, adolescent and adult subjects. Smart One is indicated for monitoring asthma, COPD and other respiratory diseases.
  • Page 6 The MIR SMART ONE app can calculate the PEF or FEV1 predicted value, i.e. the expected value for healthy people, depending on age, height, sex, and origin. MIR SMART ONE app calculate the PEF or FEV1 predicted value that has been endorsed by ATS (American Thoracic Society): for PEF the predicted values are calculated according to Knudson, R.
  • Page 7 Smart One PEF table Male (L/m) Height (cm) PEF table female (L/m) Height (cm) Rev.2.9 User Manual Page 7 of 33...

  • Page 8: Warnings And Precautions

    Smart One CAUTION: NO MATTER WHICH METHOD YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL PREFERS TO USE, IT IS IMPORTANT THAT YOU CLEARLY UNDERSTAND THE MEANING OF YOUR BASELINE VALUE AND HOW IT RELATES TO YOUR TREATMENT PLAN. IF YOU HAVE TROUBLE DETERMINING YOUR BASELINE VALUE, ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL FOR ASSISTANCE.
  • Page 9 AVAILABLE. IF ANOTHER PERSON INTENDS TO USE THE DEVICE PERMANENTLY, THE PREVIOUS DATA STORED BY THE MIR SMART ONE APP MUST BE REMOVED AND THE NEW BASELINE VALUE FOR PEF OR FEV1 MUST BE DEFINED ACCORDING TO A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
  • Page 10 Enter your personal details: date of birth, origin, weight, height, sex. The MIR SMART ONE APP will use these data to calculate PEF or FEV1 baseline value, and will use it to assign a colored marker to your test (green, yellow, red). Please refer to the section DETERMINING YOUR PEF OR FEV1 BASELINE VALUE for a clear understanding of the baseline value.
  • Page 11 SMART ONE connects to a smartphone via Bluetooth SMART technology. Connection is automatic once the MIR SMART ONE APP has been installed on your smartphone. Each measure of PEF or FEV1 is transferred from the device to the smartphone to be displayed.

  • Page 12: Diary Record

    SMART ONE meter. Diary record The MIR SMART ONE APP keeps a record of your highest reading of PEF or FEV1 for both morning and evening session, complete with date and time. Dots between consecutively recorded readings are connected in order to form a trend graph. This on–going record is an important part of your asthma action plan.

  • Page 13: Self–Measuring Of Pef Or Fev1 Value

    SMART ONE must be cleaned as shown in CARE AND CEANING section before your initial trial and periodically thereafter. To carry out a measurement:  Run the MIR SMART ONE APP on your smartphone Press the START icon  ...
  • Page 14 Smart One Push the turbine into the slot until it stops Turn the turbine clockwise until it stops Insert mouthpiece at least 0.5 cm into the Your SMART ONE is now ready. turbine socket. Hold SMART ONE with your hand as if it were a cell phone and make sure not to obstruct the turbine with your hand.
  • Page 15 Smart One Insert the mouthpiece end into your mouth beyond your teeth, and close lips around the mouthpiece. Make sure your lips form a tight seal around the mouthpiece. To prevent turbulence that might otherwise affect the results do not put your tongue in the mouthpiece.

  • Page 16: Interpreting Results

    Smart One Interpreting results Three tests are performed per each session, after which the MIR SMART ONE APP automatically selects and save the highest PEF or FEV1 value and compares it with the baseline value. The app shows a graphic marker (green, yellow or red), which is then displayed as a colored circle around the test result.
  • Page 17 Smart One CAUTION: THE ACTION PLAN GIVEN TO YOU BY YOUR PHYSICIAN OR OTHER LICENSED HEALTH CARE PROFESSIONAL WILL TELL YOU WHAT ACTION TO TAKE WHEN THERE ARE CHANGES IN YOUR PEF OR FEV1 MEASURES. CAUTION: NO MATTER WHAT YOUR PEF OR FEV1 MEASURES ARE, IF YOU HAVE SIGNS AND SYMPTOMS SUCH AS CHEST TIGHTNESS, SHORTNESS OF BREATH, COUGHING OR WHEEZING YOU SHOULD CONTACT YOUR PHYSICIAN OR LICENSED HEALTH CARE PROFESSIONAL.

  • Page 18: Warnings For Use In Electromagnetic Environments

    Smart One Data security warnings Your smartphone stores your 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: ...

  • Page 19: Notes On Fcc Certification

    Smart One  Make sure that the SMART ONE and the smartphone on which the MIR SMART ONE APP is installed are no more than 2 metres apart.  Do not use SMART ONE near other devices (computers, cordless phones, cell phones, etc.) that generate strong electromagnetic fields.

  • Page 20: Cleaning And Disinfection Of The Turbine

    Smart One  Cleaning and disinfection of the turbine  Cleaning and disinfection of the mouthpiece  Cleaning of the device  Replacing batteries Cleaning and disinfection of the turbine To avoid irreparable damage to the turbine, do not use any alcoholic or oily cleaning solutions, and do not immerse in hot water or solutions.

  • Page 21: Cleaning And Disinfection Of The Mouthpiece

    Smart One After cleaning, insert the turbine into the socket in the direction indicated by the screen– printed closed padlock symbol on the SMART ONE. To insert the turbine correctly, push it down and turn clockwise until it stops; to make sure it is fully inserted into the plastic container.

  • Page 22: Error Messages

    Smart One Remove the battery cover on the back Remove the two batteries and replace of the SMART ONE them with two new ones, following the polarity as indicated by the symbols in the compartment Reattach the battery cover 8. ERROR MESSAGES If you encounter any problems when using the SMART ONE, a message will appear on the smartphone display to warn of the malfunction.

  • Page 23: Troubleshooting

    Smart One MESSAGE POSSIBLE CAUSE REMEDY Bluetooth Bluetooth is off To perform measurements with the device, you must activate Bluetooth on the smartphone. Exit the app and activate Bluetooth from the smartphone settings menu Battery low When the SMART ONE Replace the SMART ONE batteries batteries are below 15% It seems that you...

  • Page 24: Accuracy And Reliability

    Smart One MALFUNCTION POSSIBLE CAUSE REMEDY SMART ONE The Bluetooth connection Look for SMART ONE on the list of can’t connect with is not working properly recognized devices. For correct use, smartphone the smartphone needs Bluetooth version 4.0 or higher The turbine may be dirty Clean the turbine as described in the Maintenance section.
  • Page 25 Smart One SYMBOL DESCRIPTION Product Name Device serial number Manufacturer’s name and address This product is a certified Class IIa medical device, and complies with the requirements of Directive 93/42/EEC. 0476 In accordance with IEC 60601–1 the product and its applied parts are type BF and thus protected against the risks of electrical leakage.

  • Page 26: 12. Technical Specifications

    Smart One 12. TECHNICAL SPECIFICATIONS Peak Expiratory Flow PEF (L/minute) Forced Expiratory Volume in 1 second FEV1 (L) Measurement system Bi–directional turbine (rotating blade) Measurement principle Infrared interruption Peak Flow max PEF 960 L/m (16 L/s) Volume max FEV1 10 L Volume accuracy ...
  • Page 27 Smart One 13. BLUETOOTH WIRELESS TECHNOLOGY INFORMATION Bluetooth Compliance: Version 4.0 single mode low energy Operating Frequency: 2.4 to 2.4835 GHz Max Output Power: TX: -5.99 dBm; 0.25 mW Operating Range: 10 meter radius (line of sight) Network Topology: Star - bus Operation: Server Antenna Type:...

  • Page 28: Radio Frequency (Rf) Interference From Other Wireless Devices

    Common consumer electronic devices that transmit in the same frequency bands used by the Smartone may prevent the uploader or mobile device from receiving data. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
  • Page 29 Smart One 14. INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer’s declaration – electromagnetic emissions The Smart One is intended for use in the electromagnetic environment specified below. The customer or the user of the Smart One should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 30 Smart One transient/burst input/output lines IEC 61000-4-4 Surge ±1 kV differential Not Applicable mode IEC 61000-4-5 ±2 kV common mode Voltage dips, short <5 % UT Not Applicable interruptions and (>95 % dip in UT) voltage variations for 0,5 cycle on power supply input lines 40 % UT...
  • Page 31 Smart One separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 Vrms d not applicable IEC 61000-4-6 150 kHz to 80 MHz d= 0,175 √P 80 MHz to 800 GHz Radiated RF 3 V/m 20 V/m...

  • Page 32: Rev.2.9

    Smart One Recommended separation distances between portable and mobile RF communications equipment and the Smart One The Smart One is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Smart One can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Smart One as recommended below, according to the maximum output power of the communications equipment.
  • Page 33 Forwarding to the manufacturer requires the written permission of the manufacturer himself. The manufacturer – MIR MEDICAL INTERNATIONAL RESEARCH S.r.l. – reserves the right to replace the product or make any changes deemed necessary. Rev.2.9...

Table of Contents