MIR SPIROBANK Oxi User Manual Download

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Spirobank Oxi

ENGLISH

Ver. 1.5

User Manual

Page 1 di 33

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

Summary of Contents for SPIROBANK Oxi

Page 1: ...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 RES...

Page 2: ...6 1 Results diary 15 2 7 Important safety warnings 15 2 8 Data security warnings 16 2 9 Warnings for use in electromagnetic environments 17 2 10 Notes on FCC certification 17 3 MAINTENANCE AND CLEANL...

Page 3: ...AAA batteries The User Manual After removing the device from its packaging check that there is no visible damage If it looks damaged do not use the device and send it straight back to the manufacturer...

Page 4: ...lysis of the test results alone will not be enough to diagnose your clinical condition you will need a medical examination which will take your clinical history into account as well as any other tests...

Page 5: ...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 ensure...

Page 6: ...ed Expiratory Volume in the initial 2 seconds of the test FEV3 Forced Expiratory Volume in the initial 3 seconds of the test FET Forced Expiratory Time PEF Time Time to achieve 90 of the PEF Also in t...

Page 7: ...inspired during the total inspiration FEF25 is the Forced Expiratory Flow at 25 of FVC FEF50 is the Forced Expiratory Flow at 50 of FVC FEF75 is the Forced Expiratory Flow at 75 of FVC EVol is the bac...

Page 8: ...ables tracing the possible variations of the parameters These variations might require suitable treatment according to the prescription of the physician As well as viewing the measurements of the resp...

Page 9: ...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 It is important to know that these predict...

Page 10: ...een the Spirobank Oxi and the smartphone is automatic To check whether there is a connection read the messages from the application 2 4 Performing the spirometry test To perform the test correctly fol...

Page 11: ...ure not to obstruct the turbine with your hand 5 Insert the mouthpiece in your mouth beyond your teeth and close your lips tightly over it so that the air you breathe has to pass only through the mout...

Page 12: ...ce from the mouth and check the data on the smartphone After taking the mouthpiece out of your mouth avoid sudden movements because this will push air into the turbine and a flow value will be measure...

Page 13: ...age 2 Tap the Start Test icon under OXIMETRY on the MIR SPIROBANK application 3 During the test the perfusion index is reported with a bar indicator Minimum duration of a test is 30 seconds The device...

Page 14: ...YOUR PHYSICIAN OR LICENSED HEALTHCARE 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 EX...

Page 15: ...ld 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...

Page 16: ...e 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 Ina...

Page 17: ...res If a use under lower distances is necessary Spirobank Oxi and the other devices should be kept under observation to verify that they are functioning normally 2 10 Notes on FCC certification This d...

Page 18: ...ent into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help 3 MAINTENANCE AND CLEANLINESS Spirobank Oxi is...

Page 19: ...etergents 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 moveme...

Page 20: ...each use To clean the mouthpiece simply pull it apart from the turbine Using the same method as for the turbine immerse the mouthpiece in warm soapy water and shake the mouthpiece for 2 3 minutes Rin...

Page 21: ...t air dry Never immerse the device in water or other fluids 3 5 Replacing batteries The device continuously monitors the battery level A message on the smartphone display alerts the user when the devi...

Page 22: ...i 33 3 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...

Page 23: ...2 Troubleshooting If you receive an unusually low reading it could mean that your FlowMir meter is broken or that the reading is accurate and your asthma is getting worse Check that the FlowMir is not...

Page 24: ...on the display and wait at least 30 seconds for the test to complete 5 ACCURACY AND RELIABILITY This device meets the requirements of the following standard ATS ERS TASK FORCE Standardization of lung...

Page 25: ...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 26: ...ctive 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 aut...

Page 27: ...afely exposed Humidity limitation indicates the range of humidity to which the medical device can be safely exposed Pressure limitation indicates the range of pressure to which the medical device can...

Page 28: ...um Flow at 25 of FVC FEF25 L s Maximum Flow at 50 of FVC FEF50 L s Maximum Flow at 75 of FVC FEF75 L s Extrapolated Volume EVol mL Forced Expiratory Time FET s Time to achieve 90 of the PEF PEF Time m...

Page 29: ...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 2015 EN IEC 6...

Page 30: ...d 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...

Page 31: ...nce 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 wer...

Page 32: ...ular 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 inter...

Page 33: ...ical or safety regulations in the Country where the device was purchased Use of the product for purposes other than those provided or failure to follow instructions Repair adaptation modification or t...

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