SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -1 / 44 SPIROHOME® ULTRASONIC SPIROMETER The document will be signed after revision. FUNCTION Prepared by Regulatory Affairs Deniz SARP Reviewed by Quality Assurance Ahmet Gökdere Approved by CEO Merthan Öztürk DATED SIGNED REVISION RECORD REVISION NUMBER DATE COMMENTS 00 24.02.2019 Initial Issue Spirohome® Personal User Manual Rev.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -2 / 44 Spirohome® Personal User Manual Spirohome® Personal User Manual Rev.00 Feb 2019 İnofab Sağlık Teknolojileri A.Ş. ODTÜ Teknokent / Silikon Blok K:1 No:15-A Çankaya / Ankara / Turkiye www.spirohome.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -3 / 44 1.Preface 1.1 Spirohome® Personal user manual version history Version Number Publication Date Description Rev.00 24.02.2019 Initial version for market launch This revision of the Spirohome® Personal user manual applies to Spirohome® Personal devices with a serial number between S011900001-S011900150.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -4 / 44 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -5 / 44 Table of Contents 1. 2. 3. 4. 5. 6. 7. 8. Preface 1.1 Spirohome® Personal user manual version history 1.2 Intended use of the Spirohome® Personal 1.3 About this user manual 1.4 Legal Information 1.5 Electromagnetic interference 1.6 Product disposal 1.7 Manufacturer Information Safety Information 2.1 Safety warnings and precautions 2.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -6 / 44 8.2 Cleaning of the Spiroway® mouthpiece 8.3 Replacing batteries 9. Terms of warranty 9.1 Terms of warranty for the Spirohome® Personal 10. Appendix 8.1 Electromagnetic compatibility 2. Safety Information 2.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -7 / 44 Please ensure that your personal data such as height, weight, age, sex and ethnicity are entered according to your current state and that the values are entered correctly. Regardless of the data presented on the Spirohome® Personal, if you feel unwell or have respiratory illness symptoms please contact your healthcare provider immediately.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -8 / 44 Pulmonary function tests require maximum effort on the part of the patient and may lead to sensations of dizziness or giddiness. Do not perform more than 8 spirometry tests in one spirometry session. If you sense dizziness while performing a test, stop the test immediately and rest.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -9 / 44 The spirometry tests should only be performed by users who do not experience any shortness of breath and are in good health for performing a lung function test. Test results of patients who do not meet these conditions may not be reliable.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -10 / 44 Humidity limit Atmospheric pressure limit Do not use if package is damaged Keep away from sunlight Keep dry Single use only Type BF of Medical Electrical Equipment SN Serial Number Lot Number Ref Number Spirohome® Personal User Manual Rev.00 Feb 2019 İnofab Sağlık Teknolojileri A.Ş.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® IP Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -11 / 44 IP Number Device includes RF transmitters The instruction manual/booklet must be read. 3. About the Spirohome® Personal 3.1 Product description The Spirohome® Personal is a portable spirometer that pairs (via Bluetooth®) to smart devices running with iOS or Android.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -12 / 44 Caution!: Please check to ensure that there is no visible damage on any of the components of the Spirohome® Personal. If damage is present, do not use or attempt to repair the device, please contact the manufacturer directly. Connected smart device requirements: Spirohome® Personal with iOS device: Requires İOS 11.0 or later.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -13 / 44 4. Cybersecurity To protect your device and data, please read and apply the following guidance. 4.1 About cybersecurity and your Spirohome® Personal The Spirohome® Personal platform involves the connection of your Spirohome® Personal device to the Spirohome® Personal app.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -14 / 44 2. If your password has been breached, try resetting your password through your registered email address by clicking ‘Forgot Password’. 3. Contact manufacturer 4.6 Lost or stolen devices If your Spirohome® Personal device is lost or stolen, please report the issue immediately and directly to you Spirohome® Personal provider.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -15 / 44 .
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® on the device. Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -16 / 44 available devices. Your device should now be paired. 6.4 Device indicators There are 3 LED lights located on the front of the device. The following picture shows the assigned numbers to each LED. The LED lights may be turned on or flashing various colors and/or in various patterns.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -17 / 44 LED number 3 is constantly flashing green The device is switched on LED number 2 is fading blue The device is connected to the app. Bluetooth® connection has been established. LED number 2 and LEDs 1 and 3 together are flashing in turn. The baseline is setting up. LED number 1 is constantly blue. The device is ready for a test.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Flow resolution 1 mL/s Medical device class Class IIA Wireless connection BLE 4.2 Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -18 / 44 6.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -20 / 44 Error 01 Bluetooth® is disabled Enable Bluetooth® on your smart device from its settings menu Error 02 Batteries of the Spirohome® Personal need to be replaced Replace batteries as described in the Maintenance section of this user manual Components not attached correctly.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -21 / 44 on the app interface.You also have the option to view the results of each spirometry test performed in a spirometry session separately. General method for performing a spirometry test with the Spirohome® Personal: 1. Remove the Spiroway® reusable mouthpiece from its plastic packaging and insert it all the way into the Spirohome® Personal as shown.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -22 / 44 3. The first step will be to record a baseline for the device. To perform the baseline setup, place the device cap on and stabilize the device during the baseline setup. Alternatively, place the device on a flat surface and allow the baseline setup to be completed. 4. You will then be prompted to perform a spirometry test.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -23 / 44 5. Perform the breathing maneuver related to the specific test you wish to perform. Please see the Breathing Maneuvers section of this user manual for more information. 7.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® FVL FVC* L PEF* L/s MET25-75** s MMEF/FVC** 1/s BEV* L FEF25 (MEF75)** L/s FEF50 (MEF50)** L/s FEF75 (MEF25)** L/s FEF25-75 (MMEF25-75)* L/s FEF50/FVC** - FET* s FEV.75** L FEV1* L FEV3** L FEV6** L FEV.75/FVC** - FEV1/FVC* - FEV3/FVC** - FEV6/FVC** - FEV0.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® SVC MVV FIV1/FIVC (FIR)** - FVC* L MET25-75** s MMEF/FVC** - PEF* L/s PIF* L/s R50(FEF50/FIF50)** - VC* L VCin* L VCex* L ERV* L IC** L IRV* L VT* L MVV* L/min MVV6* L/min VT* L RF* 1/min MVVtime* s Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page Abbreviations Definition BEV Back extrapolated volume ERV Expiratory reserve volume - maximal volume of air that can be exhaled from the end-expiratory position FEF25 Forced expiratory flow at 25% of vital capacity FEF25-75 Forced expiratory flow from 25% to 75% of vital capacity FEF50 Forced expiratory flow at 50% of vital capacity FEF75 Forced expiratory flow at 75
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page FIV1/FIVC Ratio of FIV1 to FIVC FIVC Forced inspiratory vital capacity FVC Forced vital capacity IC Inspiratory capacity - the sum of IRV and TV IRV Inspiratory reserve volume - maximal volume of air that can be inhaled from the end-expiratory position MEF25 Maximal instantaneous forced expiratory flow where 25 % of the FVC remains to be expired MEF50 Maximal i
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® VCex Expiratory vital capacity VCin Inspiratory vital capacity VT Tidal volume Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -28 / 44 The device also provides a reference value (obtained from large epidemiological studies) based on the patient’s height, weight, age, sex and ethnicity.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -29 / 44 guide on app screen) without breaking the seal of your lips, and then inhale a small amount of air to signal the end of your exhalation. You may use a nose clip to help you exhale through only your mouth during this maneuver. 4. You may remove the mouthpiece from your mouth and resume normal breathing once the breathing maneuver has been completed.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -30 / 44 your lips sealed tightly around it), inhale and exhale normally a couple of times, and then take a slow and deep breath, filling your lungs completely.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -31 / 44 temperature entered must be within 1°C or 1.8°F accuracy. 3. After confirming the temperature you have entered, you are ready to perform the breathing maneuver. 4. Place the mouthpiece in your mouth past your teeth and ensure your lips are tightly sealed around the mouthpiece. 5.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -32 / 44 this breathing maneuver until you have acceptable test results. However, ensure that you have rested between tests and feel well enough to continue. For more information about test quality grading refer to the Understanding test quality section of this user manual. 12.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -33 / 44 A At least 3 acceptable trials AND the difference between the best VC values is equal to or less than 150 mL. B At least 2 acceptable trials AND the difference between the best VC values is equal to or less than 150 mL. C At least 2 acceptable trials but the results are not reproducible according to 'B'. D One acceptable test.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -34 / 44 infections resulting from contact with the device. Be sure to wash your hands with soap before and after each use of the device. The cleaning procedure and disinfection process is described below: 1.Before beginning the procedure wash hands thoroughly with soap and water. 2.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -35 / 44 Personal once a week, always performing the cleaning procedure before the disinfection procedure. CaviWipes1TM Disinfectant wipes (Metrex Research LLC) is a high-level disinfectant wipes for this purpose and available at https://www.metrex.com/en-us/products/surface-disinfectants/caviwipes. 4.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -36 / 44 8.2 Cleaning the Spiroway® reusable mouthpiece The Spiroway® reusable mouthpiece should be cleaned weekly or whenever it is visibly contaminated. Clean the Spiroway® reusable mouthpiece by gently agitating it in water containing dishwashing liquid, rinsing under clean water, and leaving upright on a lint-free cloth to air-dry completely.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -37 / 44 Instructions for battery replacement 1. Remove the Spiroway® reusable mouthpiece from the device. 2. Remove the battery cover by sliding it as shown. 3. Remove the dead batteries. Spirohome® Personal User Manual Rev.00 Feb 2019 İnofab Sağlık Teknolojileri A.Ş. ODTÜ Teknokent / Silikon Blok K:1 No:15-A Çankaya / Ankara / Turkiye www.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -38 / 44 4. Place the new batteries in the correct orientation. 5. Slide the battery cover back to the closed position. 6. Insert the Spiroway® reusable mouthpiece in the right orientation. Your device is now ready to use. Spirohome® Personal User Manual Rev.00 Feb 2019 İnofab Sağlık Teknolojileri A.Ş.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -39 / 44 9. Terms of warranty 9.1 Terms of warranty for the Spirohome® Personal Spirohome® Personal, 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.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® ● Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -40 / 44 If the serial number is altered, deleted, removed or rendered illegible 9. Appendix 9.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -41 / 44 Table 1: Emission table for IEC 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic emissions 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 environments.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -42 / 44 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 environment.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -43 / 44 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 environment.
SPIROHOME® FDA DOSSIER USER MANUAL - PERSONAL SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD 24.02.2019 00 -44 / 44 Note1: At 80 MHz and 800 MHz, the higher frequency range applies. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.