SpiroHome Clinic User Manual
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SpiroHome Clinic User Manual

Ultrasonic spirometer
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Ultrasonic Spirometer
Before using your SpiroHome Clinic device and mobile application, please ensure that
you have read this user manual, all labeling and information provided the product. This
user manual is for SpiroHome Clinic (Ref No: 02000). The user manual can be
downloaded and/or printed from SpiroHome websites and SpiroHome Apps.
SUS-TD-031 R12
User Manual
Welcome to SpiroHome
02504.12
2/75

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  • Page 1 Before using your SpiroHome Clinic device and mobile application, please ensure that you have read this user manual, all labeling and information provided the product. This user manual is for SpiroHome Clinic (Ref No: 02000). The user manual can be downloaded and/or printed from SpiroHome websites and SpiroHome Apps.

  • Page 2: Table Of Contents

    OPERATION OPERATING ENVIRONMENT SETTING UP YOUR DEVICE DEVICE INDICATORS PERFORMING A LUNG FUNCTION TEST General Method For Performing a Spirometry Test with The SpiroHome Clinic: Types of Breathing Maneuvers End of the Tests Understanding the test quality SIGNS AND SYMBOLS...

  • Page 3: Introduction

    SpiroHome Clinic Cap (b) Caution: Please check to ensure that there is no visible damage on any of the components of the SpiroHome Clinic. If the damage is present, do not use or attempt to repair the device, please contact the manufacturer directly.

  • Page 4: Restrictions On Use And Contraindications

    SpiroHome Clinic is a multi-user device. The device can log the information and test results that belong to each specific patient. For each new patient, a new patient account must be created on the SpiroClinic app, so that each user's personal information and test results can be stored and logged.

  • Page 5: Parameters

    Please ask the patient if they have or suspect having any of the conditions above before use of the SpiroHome Clinic. 1.5. PARAMETERS The SpiroHome Clinic records and displays the following spirometry data: Parameters Definition Unit Forced Vital Capacity — The volume of air that can forcibly be...
  • Page 6 Forced Expiratory Volume within 0.75 seconds: The volume of air that can forcibly be blown out within 0.75 seconds, after full 0.75 inspiration. Forced Expiratory Volume within 1 second Forced Expiratory Volume within 3 seconds Forced Expiratory Volume within 6 seconds /FVC The ratio of FEV to FVC...
  • Page 7 The forced inspiratory volume within 1 second FIVC Forced inspiratory vital capacity Peak inspiratory flow Forced inspiratory flow at 25% of vital capacity — synonymous 25-75 with MIF /FIVC The ratio of FIV to FIVC The ratio of flow at 50% of expiration and flow at 50% of (FEF /FIF inspiration —...

  • Page 8: Operation

    OPERATION 2.1. OPERATING ENVIRONMENT The SpiroHome ® Clinic is designed for use in a clinical setting, by more than one user. The required operation conditions for the SpiroHome ® Clinic are: Temperature: +15°C to +35°C Relative Humidity: 10% to 85% Pressure: 700 hPa to 1060 hPa ®...
  • Page 9 4. Enable Bluetooth on the smart device or PC and pair the SpiroHome Clinic with the smart device or PC, following the instructions on the app.

  • Page 10: Device Indicators

    2.3. DEVICE INDICATORS There are 3 LED lights located on the front of the device. The LED lights may be turned on or flashing various colors and/or in various patterns. The LED lights indicate the current status of the device. Please see the following information for guidance on LED light indications.

  • Page 11: Performing A Lung Function Test

    SpiroHome Clinic: 1. Open the cap of the SpiroHome Clinic device. 2. Remove the Spiroway Disposable mouthpiece from its plastic packaging and insert it all the way into the SpiroHome Clinic in the correct orientation (as shown). SUS-TD-031 R12 12/75...
  • Page 12 3. A ‘click’ will be heard when the mouthpiece is inserted correctly all the way into the device. 4. Open the Spirohome App on a smart device. If you are not registered, register to the Spirohome app by creating a new user account and then log in. If the patient is not registered, enter the patient information from the new patient section and register the patient.
  • Page 13 The first steps will be to select test mode and enter the ambient conditions like temperature and relative humidity (in some test modes) and then adjustment zero flow level for the device. To perform zero flow level adjustment stabilize the device during the zero flow level adjustment.

  • Page 14: Types Of Breathing Maneuvers

    spirometry test. Please continue to the Type of Breathing Maneuvers section for more information. 2.4.2. Types of Breathing Maneuvers ➢ Expiration-Only (Ex-Only) Test Breathing Maneuver: 1. Ensure that the device is connected. Select the Ex-Only test mode and the test screen will appear.
  • Page 15 breathing once the breathing maneuver has been completed. 9. The test results will be displayed on the app screen. Give feedback to the patient on his/her effort by looking at the test results. The patient will need to perform 2 more tests by repeating this breathing maneuver.
  • Page 16 by repeating this breathing maneuver. However, please make sure that the patient has time to rest between tests and feels well enough to continue. NOTE: The difference between Tidal FVL and FVL is that the patient should breathe normally in the beginning of the test, in Tidal FVL test mode.
  • Page 17 ➢ The Maximum Voluntary Ventilation (MVV) Test Breathing Maneuver: 1. Ensure that the device is connected. Select the MVV test mode and the test screen will appear. 2. Enter the required ambient conditions (makes sure you entered the correct values as the measurement may be significantly affected by a wrong value) like temperature and relative humidity and then adjust zero flow level for the device.

  • Page 18: End Of The Tests

    the seal of his/her lips. 6. When performing this breathing maneuver, the patient must make sure to keep blowing until the patient feels like the patient has completely emptied his/her lungs. 7. The test can also be performed by performing the breath maneuver in the opposite direction.
  • Page 19 decided by the doctor/operator etc. This grade refers to the consistency of the patient's maneuvers, not the health of the patient's lungs. Grading of the FVC and FEV parameters in children and adults, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines; Summary of Acceptability, Usability, and Repeatability Criteria for FEV and FVC Required for...

  • Page 20: Signs And Symbols

    * Or 10% of the highest value, whichever is greater; applies for age 6 years or younger only. NA: Not Applicable 2.6. SIGNS AND SYMBOLS Please note the following label, signs and symbols provided for the safe use and storage of the SpiroHome Clinic. Markings Descriptions Markings Descriptions “Manufacturer”...

  • Page 21: Technical Features

    Type BF of Medical Sign of Conformity Electrical Equipment Disposal in Compliance with Serial Number WEEE Temperature Limit Lot Number Humidity Limit Ref Number Atmospheric pressure limitation IP Number Do not use if the package is The device includes RF damaged transmitters The instruction...

  • Page 22: Safety Warnings And Precautions

    6. Do not expose the device to liquids, prevent any liquids from entering the device. In the event of a liquid spill on or around SpiroHome, immediately remove the batteries and let the device dry thoroughly before use.
  • Page 23 To prevent damage to the Spirometry Module due to battery leakage or oxidation, remove all batteries if the SpiroHome device is not to be used or is to be stored for a long period of time. Dispose of the device and/or device batteries responsibly as required by local legislation.

  • Page 24: Maintenance

    SpiroHome Clinic as per its manufacturer’s instructions as the patients’ personal data recorded and stored on the SpiroHome Clinic App, may otherwise be at risk. The user is encouraged to not share SpiroHome app account information with unauthorised parties.

  • Page 25: Preparation Of Calibration Check

    3.1.1. Preparation of Calibration Check 1. To check the calibration of the SpiroHome Clinic, a standard 3L calibration syringe and a Spiroway Calibration-Check Adaptor must be used in the following calibration-check procedures. 2. Ensure that the temperature inside the syringe and the room are the same. This is necessary to prevent failed calibration-check due to temperature differences.
  • Page 26 Wipe all accessible surfaces of the device, using moderate pressure, as shown. CAUTION: Care must be taken to prevent any excess liquids contained within the wipes from entering the components of the SpiroHome Clinic. Never immerse the product in water or any other liquid solution.

  • Page 27: The Spiroway Disposable

    MUST use a new mouthpiece CAUTION: Risk of Cross-Contamination! SpiroHome Clinic may be used by multiple users, however, the cleaning and disinfection procedure described for the device must be performed between each new user AND a new Spiroway Disposable mouthpiece must be used for each new user.

  • Page 28: Batteries

    1.5V AAA Alkaline batteries. The battery life of the SpiroHome Clinic is approximately 12-18 months for one session (2 tests) by a day. The battery charge level is continuously monitored by the device. When the device battery charge level is low, the device will not turn on and the device will make a beeping sound to notify the user.

  • Page 29: Disposal Of Spirohome

    Bluetooth Your smart device will need Bluetooth version Bluetooth connection not 4.0 or higher. Find and select SpiroHome Clinic working properly from the list of detected devices. With the condition that it is to be used by the...
  • Page 30 The device has lost its Perform the Calibration-Check and contact the calibration. manufacturer if you have any calibration error. Close the cap of the SpiroHome to avoid The test does not effects of environmental flow start - Cannot Direct air current in the...

  • Page 31: Orderable Accessories

    TERMS OF WARRANTY SpiroHome Clinic, together with any accessories provided, is guaranteed for a period of 24 months, effective from the date of purchase, upon the provision of an invoice or sales receipt. The service life of the product is 5 years, effective from the date of purchase.

  • Page 32: Electromagnetic Compatibility

    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 33 Table 2: 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.
  • Page 34 Recommended separation distance standard level level Portable mobile communications equipment should be used no closer to any part of the SpiroHome devices including cables, than recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommend separation distance d = 1.2 √P...

  • Page 35: Manufacturer Information

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SpiroHome devices are used exceeds the applicable RF compliance level above, the SpiroHome device should be observed to verify normal operation.
  • Page 36 Address: Üniversiteler Mah. İhsan Doğramacı Blv. No: 19 Çankaya / Ankara / Turkey Tel: +90 312 988 03 08 Web: https://www.inofab.health/ The SpiroHome Ultrasonic Spirometer and Accessories are CE certified (NB1984) products. SUS-TD-031 R12 37/75...

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