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spiro h ome
│Clinic
®
User Manual
Welcome to Spirohome
®
Before using your Spirohome
®
Clinic device and mobile application, please ensure
that you have read this user manual and labels and information on the product. This
user manual is for these models: Spirohome
®
Clinic 02000, Spirohome
®
Clinic
®
02010, Spirohome
Clinic 02020. Inofab can provide user manual physical print or
digital (from İnofab Apps and İnofab websites).
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Summary of Contents for inofab Spirohome Clinic 02000
- Page 1 This user manual is for these models: Spirohome ® Clinic 02000, Spirohome ® Clinic ® 02010, Spirohome Clinic 02020. Inofab can provide user manual physical print or digital (from İnofab Apps and İnofab websites).
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Page 2: Table Of Contents
® spiro h ome │Clinic User Manual 1 / 33 CONTENTS CONTENTS INTRODUCTION PRODUCT DESCRIPTION WHAT’S IN THE BOX INTENDED USE RESTRICTIONS ON USE AND CONTRAINDICATIONS PARAMETERS OPERATION OPERATING ENVIRONMENT SETTING UP YOUR DEVICE DEVICE INDICATORS PERFORMING A LUNG FUNCTION TEST General Method For Performing a Spirometry Test with The Spirohome®... -
Page 3: Introduction
® spiro h ome │Clinic User Manual 2 / 33 INTRODUCTION 2.1. PRODUCT DESCRIPTION The Spirohome ® Clinic is a portable spirometer that pairs (via Bluetooth ® ) and operates with smart devices running with iOS, Android, or Windows. The Spirohome ®... -
Page 4: Restrictions On Use And Contraindications
® spiro h ome │Clinic User Manual 3 / 33 pulmonary disease and cystic fibrosis. These measurements can be used for the detection, assessment and monitoring of diseases affecting the lung function. and should be used by: Healthcare professionals, test operators, physicians, clinicians, occupational health professionals, etc. -
Page 5: Parameters
® spiro h ome │Clinic User Manual 4 / 33 Relative Contraindications for Spirometry; Due to increases in myocardial demand or changes in blood pressure; ➢ Acute myocardial infarction within 1 wk ➢ Systemic hypotension or severe hypertension ➢ Significant atrial/ventricular arrhythmia ➢... - Page 6 ® spiro h ome │Clinic User Manual 5 / 33 FEV Forced Expiratory Volume within 1 second FEV Forced Expiratory Volume within 3 seconds FEV Forced Expiratory Volume within 6 seconds FEV /FVC The ratio of FEV to FVC 0.75 0.75...
- Page 7 ® spiro h ome │Clinic User Manual 6 / 33 Forced inspiratory flow at 25% of vital capacity — synonymous FIF 25-75 with MIF FIV /FIVC The ratio of FIV to FIVC 1 1 R The ratio of flow at 50% of expiration and flow at 50% of (FEF...
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Page 8: Operation
® spiro h ome │Clinic User Manual 7 / 33 OPERATION OPERATING ENVIRONMENT 3.1. The Spirohome ® Clinic is designed for use in a clinical setting, by more than one user. ® The operating conditions for the Spirohome Clinic are specified as: Temperature: +15°C to +35°C Relative Humidity: 10% to 85% ®... -
Page 9: Device Indicators
® spiro h ome │Clinic User Manual 8 / 33 3. Remove the battery cover by sliding it, place batteries correct orientation, slide the battery cover back to the closed position and press on the power button to switch the device on as shown. ®... -
Page 10: Performing A Lung Function Test
® spiro h ome │Clinic User Manual 9 / 33 LED Display Indication/s None of the LEDs is on. The device is switched off. LED indicators are consecutively flashing The device is switching on. green. LED number 3 is a constant green. The device is switched on. -
Page 11: General Method For Performing A Spirometry Test With The Spirohome® Clinic
® spiro h ome │Clinic User Manual 10 / 33 3.4.1. General Method For Performing a Spirometry Test with The ® Spirohome Clinic: ® 1. Open the cap of the Spirohome Clinic device. 2. Remove the Spiroway Disposable mouthpiece from its plastic packaging and insert it ®... - Page 12 ® spiro h ome │Clinic User Manual 11 / 33 5. Select the patient name from the patient list and tap the plus button on the screen to start the test procedure from the patient details page. 6. 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 adjust the zero flow level for the device.
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Page 13: Types Of Breathing Maneuvers
® spiro h ome │Clinic User Manual 12 / 33 3.4.2. Types of Breathing Maneuvers ➢ The Forced Vital Capacity (FVC) Test Breathing Maneuver: 1. Ensure that the device is connected. Select the FVC test mode and the test screen will appear. - Page 14 ® spiro h ome │Clinic User Manual 13 / 33 3. Ask the patient to place the mouthpiece in his/her mouth, past his/her teeth and ensure that his/her lips are tightly sealed around the mouthpiece. 4. To get ready, the patient should inhale and exhale normally at least 3 times, then take a fast and deep breath, filling your lungs as much as possible.
- Page 15 ® spiro h ome │Clinic User Manual 14 / 33 inhale and exhale only through his/her mouth during this breathing maneuver. 6. The patient may remove the mouthpiece from his/her mouth and resume normal breathing once the breathing maneuver has been completed. 7.
- Page 16 ® spiro h ome │Clinic User Manual 15 / 33 ➢ End of Forced Expiration (EOFE) Some standards stress the importance of a maximal inspiration after the forced expiration. As such, the e nd of forced expiration (EOFE) is not the end of the maneuver, and hence the term EOFE is used.
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Page 17: End Of The Tests
® spiro h ome │Clinic User Manual 16 / 33 7. The test results will be displayed on the app screen. If the test fails, give feedback and guide the patient for another trial. Encourage them to breathe deep and fast and try to reach at least 12 seconds. -
Page 18: Understanding The Test Quality
® spiro h ome │Clinic User Manual 17 / 33 UNDERSTANDING THE TEST QUALITY 3.5. 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. - Page 19 ® spiro h ome │Clinic User Manual 18 / 33 If the maximal inspiration after EOFE is greater than FVC, then (FIVC — FVC) must be ≤ 0 .100 L or 5% of FVC, whichever is greater * * Repeatability criteria ...
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Page 20: Signs And Symbols
® spiro h ome │Clinic User Manual 19 / 33 SIGNS AND SYMBOLS 3.6. Please note the following label, signs and symbols provided for the safe use and storage of the Spirohome® Clinic. Markings Descriptions Markings Descriptions “Manufacturer” This symbol accompanied by the name Single-use only and the address of the manufacturer adjacent to the symbol... -
Page 21: Technical Features
® spiro h ome │Clinic User Manual 20 / 33 TECHNICAL FEATURES 3.7. Flow / Volume measurement method Ultrasonic transducer measurement Power Supply 2 x 1.5V AAA alkaline batteries Dimensions 110 x 63 x 41 mm Weight (With batteries) 90 g Weight (Without batteries) 67 g Flow range... - Page 22 ® spiro h ome │Clinic User Manual 21 / 33 If any damage is present on the device or its components upon removal from packaging, do not use the device and return it to the supplier. ® ® Do not use Spirohome for any other purpose than its intended use.
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Page 23: Maintenance
® spiro h ome │Clinic User Manual 22 / 33 ® The Spirohome Clinic should never be used with a charging smart device. Make sure the smart device is unplugged from its charger before conducting a spirometry test. Store and use the device as specified in this user manual as alternative methods or conditions of storage may affect device function and/or accuracy. -
Page 24: Calibration-Check
® spiro h ome │Clinic User Manual 23 / 33 CALIBRATION-CHECK 4.1. Due to the ultrasound-based technology for airflow analysis, routine calibration of the ® Spirohome Clinic is not necessary and technically there is no mechanism provided to the user to calibrate the device. The device is factory calibrated and a re-calibration can only be done by the manufacturer. -
Page 25: Cleaning And Disinfection
® spiro h ome │Clinic User Manual 24 / 33 CLEANING AND DISINFECTION 4.2. ® Important! : The Spirohome Clinic must be cleaned and then disinfected between each new patient. 1. Wash Hands Before beginning the cleaning procedure, wash hands thoroughly with soap and water. 2. -
Page 26: The Spiroway Disposable
To purchase a new mouthpiece, you can contact your local distributors, if there is no local distributor or you can not reach them, you can reach İnofab at https://www.inofab.health/. For more information, you can visit https://www.inofab.health/. -
Page 27: Disposal Of Spirohome
® spiro h ome │Clinic User Manual 26 / 33 Instructions for battery replacement ® 1. Open the cap of Spirohome Clinic. 2. Remove the battery cover by sliding it as shown. 3. Remove the empty batteries. 4. Place the new batteries in the correct orientation. -
Page 28: Troubleshooting
® spiro h ome │Clinic User Manual 27 / 33 TROUBLESHOOTING Problem Cause Solution Check battery orientation and correct polarities Remove the AAA batteries, wait 30 seconds and reinstall AAA batteries Device Not Multiple possible causes turning on Replace AAA batteries Check that battery cap is in the lock position, or if itis has broken, contact manufacturer The smart device is out... - Page 29 Remove the batteries, wait 30 seconds and responding to Device error reinstall batteries button For any other technical queries please call our customer service on +90 312 988 03 08 or e-mail support@inofab.health First Pub. Date: 24.09.2018 R.9-1 / 10.03.2020...
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Page 30: Orderable Accessories
Clinic Cap (Reference number: 01104) To purchase these accessories, you can contact your local distributors, if there is no local distributor or you can not reach them, you can reach İnofab at h ttps://www.inofab.health/ For more information, you can visit h ttps://www.inofab.health/... -
Page 31: 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 32 ® spiro h ome │Clinic User Manual 31 / 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 33 ® spiro h ome │Clinic User Manual 32 / 33 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.
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Page 34: Manufacturer Information
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. First Pub. Date: 24.09.2018 R.9-1 / 10.03.2020...
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