SpiroClinic Compact User Manual
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SpiroClinic Compact User Manual

Ultrasonic spirometer
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Ultrasonic Spirometer
User Manual
Welcome to SpiroClinic Compact
Before using your SpiroClinic Compact device and mobile application, please ensure that you have read
this user manual, all labelling and information provided the product. This user manual is for SpiroClinic
Compact 02000. The user manual can be downloaded and/or printed from Inofab Health's websites and
SpiroClinic Apps.
17502.03
SUS-TD-073 R03
2/73

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  • Page 1 User Manual Welcome to SpiroClinic Compact Before using your SpiroClinic Compact device and mobile application, please ensure that you have read this user manual, all labelling and information provided the product. This user manual is for SpiroClinic Compact 02000. The user manual can be downloaded and/or printed from Inofab Health’s websites and SpiroClinic Apps.
  • Page 2 NA: Not Applicable SIGNS AND SYMBOLS TECHNICAL FEATURES SAFETY WARNINGS AND PRECAUTIONS MAINTENANCE CALIBRATION-CHECK Preparation of Calibration Check CLEANING AND DISINFECTION THE SPIROWAY DISPOSABLE BATTERIES DISPOSAL OF SPIROCLINIC COMPACT TROUBLESHOOTING ORDERABLE ACCESSORIES TERMS OF WARRANTY ELECTROMAGNETIC COMPATIBILITY MANUFACTURER INFORMATION SUS-TD-073 R03 3/73...

  • Page 3: Intended Use

    SpiroClinic Compact Cap (b) Caution: Please check to ensure that there is no visible damage on any of the components of the SpiroClinic Compact. If the damage is present, do not use or attempt to repair the device, please contact the manufacturer directly.
  • Page 4 SpiroClinic Compact 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 Please ask the patient if they have or suspect having any of the conditions above before use of the SpiroClinic Compact. 1.5. PARAMETERS The SpiroClinic Compact records and displays the following spirometry data: Parameters Definition Unit SUS-TD-073 R03...
  • Page 6 Forced Vital Capacity — The volume of air that can forcibly be blown out after full inspiration 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...
  • Page 7 Forced Expiratory Time Back extrapolated volume 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...

  • Page 8: Setting Up Your Device

    2.2. SETTING UP YOUR DEVICE 1. Download the SpiroClinic App from the App Store, Google Play Store, or Microsoft Store into a smart device or PC. SUS-TD-073 R03...
  • Page 9 4. Enable Bluetooth on the smart device or PC and pair the SpiroClinic Compact with the SUS-TD-073 R03 11/73...

  • Page 10: Device Indicators

    smart device or PC, following the instructions on the app. 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.
  • Page 11 SpiroClinic Compact: 1. Open the cap of the SpiroClinic Compact device. 2. Remove the Spiroway Disposable mouthpiece from its plastic packaging and insert it all the way into the SpiroClinic Compact in the correct orientation (as shown). SUS-TD-073 R03 13/73...
  • Page 12 Hold the mouthpiece with the upper part of the plastic package. Insert the mouthpiece all into SpiroClinic Compact device correct orientation 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.
  • 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 1. Ensure that the device is connected. Select the Ex-Only test mode and the test screen will appear. 2. Read and follow the steps on the SpiroClinic application. 3. Then adjust the zero flow level for the device. 4. Patient will need to perform a forced expiratory maneuver.
  • Page 15 maneuver. 8. The patient may remove the mouthpiece from his/her mouth and resume normal 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 breathing once the breathing maneuver has been completed. 7. 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 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 the patient feels that all the air in his/her lungs feels completely empty without breaking 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.
  • Page 19 2.5. UNDERSTANDING THE TEST QUALITY After each test session, quality grading will be displayed on the app to provide information about how well the breathing maneuver was performed. Note that the acceptability of the test is purely 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.

  • Page 20: Signs And Symbols

    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 SpiroClinic Compact. Markings Descriptions “Manufacturer” This symbol accompanied by the name and the address of the...
  • Page 21 manufacturer adjacent to the symbol Sign of Conformity Disposal in Compliance with WEEE Temperature Limit Humidity Limit Atmospheric pressure limitation Do not use if the package is damaged Keep away from sunlight Keep dry Single-use only SUS-TD-073 R03 23/73...

  • Page 22: Technical Features

    Type BF of Medical Electrical Equipment Serial Number Lot Number Ref Number IP Number Antenna symbol for devices that include RF transmitters The instruction manual/booklet must be read. 2.7. TECHNICAL FEATURES Flow / Volume measurement method Ultrasonic transducer measurement Power Supply 2 x 1.5V AAA alkaline batteries Dimensions 110 x 63 x 41 mm...

  • Page 23: Safety Warnings And Precautions

    Medical device class Class IIA Wireless connection BLE 4.2 *Tested according to ISO26782 Annex B 2.8. SAFETY WARNINGS AND PRECAUTIONS Important! Please adhere to the recommendations, warnings and guidelines set out in this user manual as failure to comply may result in measurement errors, display of incorrect results or harm to the user.
  • Page 24 The user should also report such incidents to the manufacturer. The SpiroClinic Compact should never be used with a charging smart device. Make sure the smart device is unplugged from its charger before conducting a spirometry test.

  • Page 25: Maintenance

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

  • Page 26: Cleaning And Disinfection

    3.2. CLEANING AND DISINFECTION Important!: The SpiroClinic Compact must be cleaned and then disinfected between each new patient. 1. Before beginning the cleaning procedure, wash hands thoroughly with soap and water.
  • Page 27 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 SpiroClinic Compact. Never immerse the product in water or any other liquid solution.
  • Page 28 1.5V AAA Alkaline batteries. The battery life of the SpiroClinic Compact 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 Instructions for battery replacement 1. Open the cap of SpiroClinic Compact. 2. Remove the battery cover by sliding it as shown. 3. Remove the dead batteries. 4. Place the new batteries in the correct orientation. 5. Slide the battery cover back to the closed position.

  • Page 30: Troubleshooting

    Bluetooth Bluetooth connection not 4.0 or higher. Find and select SpiroClinic working properly Compact from the list of detected devices. With the condition that it is to be used by the Spiroway mouthpiece is same patient clean the Spiroway Disposable...
  • Page 31 Close the cap of the SpiroHome to avoid The test does not effects of environmental flow start - Cannot Direct air current in the Place device on a flat surface perform zero flow environment Remove causes of direct air current e.g. air level adjustment conditioner, opened window, fan, etc.

  • Page 32: Orderable Accessories

    TERMS OF WARRANTY SpiroClinic Compact, 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 33: Electromagnetic Compatibility

    Electromagnetic environment Emission Test Compliance guidance SpiroClinic uses RF energy for its internal function. Its Radio Bluetooth, BLE and WLAN module also complies with the national regulations. Therefore, its RF RF emissions CISPR 11 Group 1 emissions are very low and are not likely...
  • Page 34 environment specified below. Users of these devices should assure that it is used in such an environment. Immunity Test IEC 60601 Recommended separation Compliance level Standard test level distance ±2 kV ±8 kV contact Floor should be wood, concrete, Electrostatic ±4 kV ±2 kV air or ceramic tile.
  • Page 35 transmitter. Recommend separation distance d = 1.2 √P d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according transmitter manufacturer...

  • Page 36: Manufacturer Information

    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 equipment (transmitters) and the SpiroHome device as recommended below, according to the maximum output power of the communications equipment.
  • Page 37 The SpiroHome Ultrasonic Spirometer and Accessories are CE certified (NB1984) products. SUS-TD-073 R03 39/73...

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