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inofab SpiroHome Personal User Manual

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Personal
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User Manual
Before using your SpiroHome
Personal device and mobile application, please ensure that you
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have read this user manual and all product labelling. This user manual is available digitally or
for print through the Inofab Health Apps and Inofab Health websites.

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Summary of Contents for inofab SpiroHome Personal

  • Page 1 Before using your SpiroHome Personal device and mobile application, please ensure that you ® have read this user manual and all product labelling. This user manual is available digitally or for print through the Inofab Health Apps and Inofab Health websites.
  • Page 2 First Pub. Date: 05.03.2018 R.11-1 / 14.10.2020...

  • Page 3: Table Of Contents

    CONTENTS 1. INTRODUCTION ..........................................4 1.1.PRODUCT DESCRIPTION..........................................4 1.2.WHAT’S IN THE BOX............................................4 1.3.INTENDED USE..............................................4 1.4.RESTRICTIONS ON USE AND CONTRAINDICATIONS................................4 1.5.PARAMETERS..............................................5 2. OPERATION ............................................6 2.1.STORAGE AND OPERATING ENVIRONMENT....................................6 2.2.SETTING UP YOUR DEVICE..........................................6 2.3.DEVICE INDICATORS............................................7 2.4.SPIROMETRY MEASUREMENT........................................8 2.5.UNDERSTANDING THE TEST QUALITY.......................................10 2.6.SIGNS AND SYMBOLS..........................................13 2.7.TECHNICAL FEATURES..........................................13 2.8.SAFETY WARNINGS AND PRECAUTIONS....................................14 3.MAINTENANCE...

  • Page 4: Introduction

    1.INTRODUCTION previous user is erased from the device memory, their account is removed from the app and a new user account is created for the new user. The device 1.1. PRODUCT DESCRIPTION must also be cleaned and disinfected according to The SpiroHome Personal is a portable ®...

  • Page 5: Parameters

    risks associated with testing should always abdominal pressure; /FVC The ratio of FEV to FVC be weighed against the benefit of obtaining • Presence of pneumothorax 0.75 0.75 information about lung function. Spirometry /FVC The ratio of FEV to FVC •...

  • Page 6: Operation

    2. OPERATION 2.2. SETTING UP YOUR DEVICE 2.1. STORAGE AND OPERATING ENVIRONMENT The SpiroHome Personal is intended to ® be used in home settings. It is not intended for use in clinical settings such as hospitals or private clinics. The operating conditions for the SpiroHome Personal are: ®...

  • Page 7: Device Indicators

    2.3. DEVICE INDICATORS There are 3 LED lights located on the front of Table 2: Device Led Indicators the device. The LED lights may be turned on or flashing various colors in various patterns. The LED lights indicate the current status of the LED Display Indication/s device.

  • Page 8: Spirometry Measurement

    2.4. SPIROMETRY MEASUREMENT Setting Up Your Device Sit upright with your back straight and your feet flat on the ground. Remove the SpiroWay ® Reusable Open the SpiroHome ® Follow the instructions that Place the mouthpiece in your mouthpiece from its plastic on your smart device and appear on the screen.
  • Page 9 You will now need to perform Without hesitation and with your lips Repeat these steps for After completing your a forced expiratory maneuver. sealed tightly around the mouthpiece each successive trial, spirometry session, switch To ready yourself, inhale and blow out the air in your lungs as hard ensuring that you rest off the device by pressing exhale normally a couple of...

  • Page 10: Understanding The Test Quality

    IMPORTANT: This procedure describes how into the mouthpiece at the beginning of the before following three cases will indicate an EOFE: to perform the forced expiratory maneuver when a forceful expiration, and the test begins with a 1.Expiratory plateau (≤0.025 L in the last 1 s of ‘Tidal Mode’...
  • Page 11 Must achieve one of these three EOFE indicators: 1. Expiratory plateau (≤0.025 L in the last 1 s of expiration) 2. Expiratory time ≥15 s 3. FVC is within the repeatability tolerance of or is greater than the largest prior observed FVC * Must have no evidence of obstructed mouthpiece or spiromete Must have no evidence of a leak If the maximal inspiration after EOFE is greater than FVC, then...
  • Page 12 Table 4: Grading System for FEV and FVC (Graded Separately) Repeatability: Repeatability: Grade Number of Measurements Age >6 yr Age ≤6 yr * ≥ 3 acceptable Within 0.150 L Within 0.100 L * 2 acceptable Within 0.150 L Within 0.100 L * ≥...

  • Page 13: Signs And Symbols

    2.6. SIGNS AND SYMBOLS The following signs and symbols are provided for the safe use and storage of your SpiroHome Personal. ® 2.7. TECHNICAL FEATURES Table 5: Markings & Descriptions Table 6: Technical Features Markings Descriptions Markings Descriptions Flow / Volume measurement Ultrasonic transducer method measurement...

  • Page 14: Safety Warnings And Precautions

    2.8. SAFETY WARNINGS AND uncomfortable. If you feel sensations of dizziness remove batteries and let the device dry thoroughly PRECAUTIONS or giddiness during pulmonary function sessions, before use. then cease device use and inform your healthcare IMPORTANT: Please adhere to all safety •...

  • Page 15: Maintenance

    • Follow all data security warnings and 3.1. CLEANING AND DISINFECTION recommendations for your personal smart You should clean the SpiroHome Personal body and cap at least once a week or whenever the device ® device as per it’s manufacturer’s instructions to is visibly contaminated.

  • Page 16: Cleaning The Spiroway ® Reusable

    To purchase new mouthpieces, contact ® REUSABLE authorized local distributors or, if there is no Remove the empty batteries. local distributor, contact Inofab Health at To clean the SpiroWay Reusable mouthpiece ® www.inofab.health once a week and whenever visibly soiled;...

  • Page 17: Disposal Of Spirohome

    3.4. DISPOSAL OF SPIROHOME ® This product is not to be discarded as regular household waste and should be discarded as electronic waste in accordance with local regulations and returned to a collection point of recycling for electric and electronic devices. Used batteries should be disposed of in designated battery recycling containers in accordance with local laws and regulations.

  • Page 18: Orderable Accessories

    ® mouthpiece is damaged Replace SpiroWay ® For any other technical queries please call customer service on +90 312 988 03 08 or e-mail at support@inofab.health 5.ORDERABLE ACCESSORIES 6. TERMS OF WARRANTY The customer must return goods for replacement or repair at the customer’s expense to the authorized...

  • Page 19: Electromagnetic Compatibility

    Meeting the requirements for EMC (electromagnetic compatibility) and preventing the unsafe use of the device, medical devices including SpiroHome ® manufactured by Inofab Health Technologies conform to the EN60601-1-2 standard which defines the levels of immunity to electromagnetic interference as well as maximum levels of electromagnetic emissions for medical devices.
  • Page 20 Table 9: Immunity (Stimulation mode) table according to IEC 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic immunity SpiroHome battery-operated spirometer devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure ® that it is used in such an environment. Immunity Test Standard IEC 60601 test level Compliance level Recommended separation distance...
  • Page 21 Guidance and manufacturer’s declaration – electromagnetic immunity SpiroHome ® battery-operated spirometer devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure that it is used in such an environment. Immunity test standard IEC 60601 test level Compliance level Recommended separation distance Portable and mobile RF communications equipment must remain at the recom-...
  • Page 22 Recommended separation distances between portable and mobile RF communications equipment. SpiroHome devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of ® these SpiroHome devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications ®...

  • Page 23: Manufacturer Information

    8. MANUFACTURER INFORMATION Name İnofab Sağlık Teknolojileri A.Ş. Address Üniversiteler Mah. İhsan Doğramacı Blv. No:17/115 Çankaya/Ankara/Turkey E-mail info@inofab.health www.inofab.health The SpiroHome Ultrasonic Spirometer and Accessories are ® CE certified (NB1984) products.

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