MIR SPIROBANK Oxi User Manual
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MIR SPIROBANK Oxi User Manual

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Spirobank Oxi
ENGLISH
Oxi
Before you use your Spirobank Oxi, please read this user manual, the
labels and all the information provided with the product.
User Manual Rev 1.5
Publication date
04.02.2022
0476
WARNING: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR BY REQUEST OF A PHYSICIAN
Ver. 1.5
User Manual
Page 1 di 33

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  • Page 1 Spirobank Oxi ENGLISH Before you use your Spirobank Oxi, please read this user manual, the labels and all the information provided with the product. User Manual Rev 1.5 Publication date 04.02.2022 0476 WARNING: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR BY REQUEST OF A PHYSICIAN Ver.

  • Page 2: Table Of Contents

    Intended use ......................... 4 1.1.1 Restrictions on Use ....................4 Description of product ....................5 Information on the parameters measured by Spirobank Oxi ........7 Determining your baseline values ................. 9 USE OF Spirobank Oxi ......................9 Inserting the batteries ....................9 Installing the MIR SPIROBANK application ..............
  • Page 3 ENGLISH Thank you for choosing a MIR MEDICAL INTERNATIONAL RESEARCH product. Before you use your Spirobank Oxi, please read this user manual, the labels and all the information provided with the product. Before connecting Spirobank Oxi to a smartphone, install the MIR SPIROBANK application, available by smartphone in both iOS and Android operating systems.

  • Page 4: Introduction

    Spirobank Oxi ENGLISH MIR cannot be held responsible for any damage caused by users failing to follow these instructions and/or the warnings contained in this manual. 1. INTRODUCTION Intended use , spirometer and pulse oximeter, is intended to be used by a physician or Spirobank Oxi by a subject under the instruction of a physician or the patient to assess lung function.

  • Page 5: Description Of Product

    • BPM (heart rate) The device connects to a smartphone via Bluetooth SMART technology. Connection is automatic once the MIR SPIROBANK application has been installed on the smartphone. Measurement is performed by a turbine sensor, and is based on the infrared interruption principle. This principle ensures that the measurement is accurate and reproducible.
  • Page 6 Spirobank Oxi ENGLISH • FEV05 - Forced Expiratory Volume in the initial 0,5 seconds of the test • FEV075 - Forced Expiratory Volume in the initial 0,75 seconds of the test • FEV2 - Forced Expiratory Volume in the initial 2 seconds of the test •...

  • Page 7: Information On The Parameters Measured By Spirobank Oxi

    Spirobank Oxi ENGLISH Information on the parameters measured by Spirobank Oxi Spirometry tests PEF is the maximum speed of the air when you exhale as hard as possible after filling your lungs completely. FEV1 is the volume of air expelled during the first second of the same exhalation.
  • Page 8 Spirobank Oxi ENGLISH Spirobank Oxi is a valid help in identifying whether there is an obstruction at a determined time and of what type of obstruction it is. Regular use of the device enables tracing the possible variations of the parameters. These variations might require suitable treatment, according to the prescription of the physician.

  • Page 9: Determining Your Baseline Values

    First you need to install application on your remote device (smartphone or tablet). The application is available for smartphone/tablet in both iOS and Android environments. Once the application is available, enter the patient's data; MIR SPIROBANK application will automatically calculate the baseline reference values.

  • Page 10: Connection Between Spirobank Oxi And Smartphone

    Spirobank Oxi ENGLISH Connection between Spirobank Oxi and smartphone The connection between the Spirobank Oxi and the smartphone is automatic. To check whether there is a connection, read the messages from the application. Performing the spirometry test To perform the test correctly, follow the instructions below.
  • Page 11 Spirobank Oxi ENGLISH Insert the mouthpiece at least 0.5 cm into Pick up the Spirobank Oxi with your hands the turbine socket as if it were a mobile phone. Make sure not to obstruct the turbine with your hand. Insert the mouthpiece in your mouth “Start...
  • Page 12 Repeat the test three times. The MIR SPIROBANK will save the highest value. The device shows an error message if the exhalation start-up was not satisfactory and if the exhalation did not finish satisfactorily.

  • Page 13: 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 Spirobank Oxi on the sensor as in the image on the MIR SPIROBANK application. During the test the perfusion index is reported with a bar indicator.

  • Page 14: Evaluating The Test

    PROFESSIONAL TO WATCH YOU USING THE Spirobank Oxi BEFORE RELYING ON ANY MEASUREMENT. WARNING: WHEN Spirobank Oxi IS USED TO MONITOR A LUNG CONDITION SUCH AS FOR EXAMPLE ASTHMA YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.

  • Page 15: Results Diary

    Spirobank Oxi ENGLISH 2.6.1 Results diary The test results are automatically stored on the smartphone and can be displayed later. 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.

  • Page 16: Data Security Warnings

    Spirobank Oxi ENGLISH 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. Data security warnings The smartphone stores the user’s personal data.

  • Page 17: Warnings For Use In Electromagnetic Environments

    For the device to function properly, however, the following precautions must be taken: • Make sure that the Spirobank Oxi and the smartphone on which the MIR SPIROBANK application is installed are no more than 2 metres apart.

  • Page 18: Maintenance And Cleanliness

    − Consult the dealer or an experienced radio/TV technician for help. 3. MAINTENANCE AND CLEANLINESS Spirobank Oxi is a device requiring little maintenance. The following operations must be carried out regularly: • Cleaning the reusable turbine • Replacing the FlowMir® turbine •...

  • Page 19: Cleaning The Reusable Turbine

    Spirobank Oxi ENGLISH Cleaning of the reusable turbine The following instruction should be applied in a case of reusable turbine. 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.

  • Page 20: Cleaning Of The Mouthpiece

    After each session, then every time you change patients, replace the FlowMir® turbine with a new one. Then detach the one applied to Spirobank Oxi, operating in reverse order to the one described in point 2.4; then apply a new FlowMir® before performing a new test session. The FLowMir®...

  • Page 21: Replacing Batteries

    1000 tests, whichever comes first. Remove the battery cover on the back of Remove the two batteries and replace the Spirobank Oxi. them with two new ones, following the polarity as indicated by the symbols in the battery compartment.
  • Page 22 Spirobank Oxi ENGLISH Reposition the battery cover. Used Spirobank Oxi batteries should only be disposed of in special containers or preferably returned to the dealer or to a special collection centre. In any case, all applicable local regulations must be complied with.

  • Page 23: Error Messages & Troubleshooting

    Spirobank Oxi ENGLISH 4. ERROR MESSAGES & TROUBLESHOOTING Error messages If you encounter any problems when using the Spirobank Oxi, a message will appear on the smartphone display to warn of the malfunction. MESSAGE POSSIBLE CAUSE SOLUTION Bluetooth Bluetooth is deactivated To perform measurements with the device, you must activate Bluetooth on the smartphone.

  • Page 24: Accuracy And Reliability

    Spirobank Oxi ENGLISH PROBLEM POSSIBLE CAUSE SOLUTION test performed Repeat the test, following the directions wrongly displayed on the screen. Avoid sudden movements when you finish exhaling The turbine has not been Insert the turbine from the front of the...
  • Page 25 Spirobank 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 26: Labels & Symbols

    Symbol Description Model: Product Name Series number of the device Manufacturer’s name and address: MIR s.r.l. Medical International Research, via del Maggiolino 125, 00155 Rome, Italy This product is a certified Class IIa medical device, and complies with the requirements...

  • Page 27: Technical Specifications

    Spirobank Oxi ENGLISH Symbol Description The symbol is used to indicate that the product contains 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...
  • Page 28 Spirobank Oxi ENGLISH Additional measured spirometry parameters in the F/V version only: Peak Inspiratory Flow PIF (L/min) Inspiratory Volume in one second of the inspiration FIV1 (L) Forced Inspiratory Vital Capacity FIVC (L) Expiratory Volume in the initial 0,5 seconds of the test FEV05 (L)
  • Page 29 Spirobank Oxi ENGLISH Cardiac frequency measurement 30-200 BPM range 3% BPM accuracy Communication interface Bluetooth SMART ( 5-Ready Electrical power supply 2 x 1.5V AAA alkaline batteries Measurements Main body 109x49x21 mm Weight 60.7 g (including batteries) Type of electrical protection...

  • Page 30: Bluetooth Wireless Technology Information

    Spirobank 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 31: Communication At Radiofrequency (Rf)

    The majority of consumer electronic devices on the same frequency band as used by Spirobank Oxi 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.
  • Page 32 Spirobank Oxi ENGLISH 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.

  • Page 33: Warranty Terms

    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. MIR Medical International Research reserves the right to replace the product or bring modifications deemed necessary to it. Ver. 1.5...

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