SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -1 / 45 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® Clinic User Manual Rev.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -2 / 45 Spirohome® Clinic User Manual Spirohome® Clinic 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 - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -3 / 45 1.Preface 1.1 Spirohome® Clinic user manual version history Version Number Publication Date Description Rev.00 24.02.2019 Initial version for market launch This revision of the Spirohome® Clinic user manual applies to Spirohome® Clinic devices with a serial number between S011900001-S011900150.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -4 / 45 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 - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -5 / 45 Table of Contents 1. 2. 3. 4. 5. 6. 7. 8. Preface 1.1 Intended use of the Spirohome® Clinic 1.2 About this user manual 1.3 Legal Information 1.4 Electromagnetic interference 1.5 Product disposal 1.6 Manufacturer Information Safety Information 2.1 Safety warnings and precautions 2.2 Restrictions on use and contraindications 2.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -6 / 45 8.3 Replacing batteries 9. Terms of warranty 10. Appendix 8.1 Electromagnetic compatibility 2. Safety Information 2.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -7 / 45 Data: Only a qualified healthcare professional can make a diagnosis with, in addition to other medical testing and the patient’S clinical history, the data presented by the Spirohome® C linic.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -8 / 45 Pulmonary function tests require maximum effort on the part of the patient and may lead to sensations of dizziness or giddiness. Do not ask the patient to perform more than 8 spirometry tests in one spirometry session. If the patient senses dizziness while performing a test, stop the test immediately and allow the patient to rest.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -9 / 45 The spirometry tests should only be performed by patients 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 - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -10 / 45 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® Clinic User Manual Rev.00 Feb 2019 İnofab Sağlık Teknolojileri A.Ş.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® IP Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -11 / 45 IP Number Device includes RF transmitters The instruction manual/booklet must be read. 3. About the Spirohome® Clinic 3.1 Product description The Spirohome® C linic is a portable spirometer that pairs (via Bluetooth®) to smart devices running with iOS or Android.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -12 / 45 Caution!: Please check to ensure that there is no visible damage on any of the components of the Spirohome® C linic. If damage is present, do not use or attempt to repair the device, please contact the manufacturer directly. Connected smart device requirements: Spirohome® C linic with iOS device: Requires İOS 11.0 or later.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -13 / 45 4.Cybersecurity To protect your device and data, please read and apply the following guidance. 4.1 About cybersecurity and your Spirohome® C linic The Spirohome® C linic platform involves the connection of the Spirohome® Clinic device to the ® Spirohome C linic app.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -14 / 45 regularly backed-up on Spirohome® s ervers. It is the responsibility of the institution to back-up any data that is stored on the servers of the healthcare institution or on the smart device itself. 5. Spirohome® Clinic and smart device connectivity 5.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -15 / 45 The device should not be used in direct air currents (e.g. wind), sources of heat or cold, direct sun rays or other sources of light or energy, dust, sand or any other chemical substances.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -16 / 45 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. The LED lights indicate the current status of the device.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -17 / 45 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. During a test, LED number 1 is constantly yellow. The test has timed-out (there has been no inhalation/exhalation over a period of time) During baseline setup LED umber 1 is constantly yellow.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Problem Document No Publication Date Revision Number Revision Date Page Cause SUS-FDAD2 08.03.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -19 / 45 Close the cap of the Spirohome® Clinic to avoid effects of environmental flow Test does not start - Cannot set up baseline Direct air current in environment Place device on a flat surface Remove causes of direct air current e.g. air conditioner, opened window, fan, etc.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -20 / 45 Sensors are obstructed. Ensure that the components are clean and clear of foreign body materials. Test was not performed correctly. Repeat the test following the rules and conditions specified in the Performing a Lung Function Test section of this user manual.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -21 / 45 mouthpiece is inserted correctly all the way into the device. A click will be heard when the Spiroway® disposable mouthpiece is inserted correctly and fully into the Spirohome® Clinic. 2. Load the Spirohome® Clinic App on the smart device and sign in to the patient’s account. 3.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -22 / 45 5. 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. 6. The app will prompt the operator to start a spirometry test.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page Spirohome® Clinic 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.io SUS-FDAD2 08.03.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -24 / 45 7. Perform the breathing maneuver related to the particular spirometry test. Please see the Breathing Maneuvers section of this user manual for more information. 7.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® FVL 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 - CLINIC SPIROHOME® SVC MVV 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-FDAD2 08.03.2019 00 -26 / 45 *Primary parameters are displayed as default on the results screen of the app after each spirometry session.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page 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% of vital capacity FEF50/FVC Ratio of FEV50 to FVC F
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page 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 instantaneous forced expiratory flow where 50 % of the FVC remains to be expired MEF
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® VT Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -29 / 45 Tidal volume The device also provides a reference value (obtained from large epidemiological studies) based on the patient’s height, weight, age, sex and ethnicity. The patient’s spirometry test results compared to the reference value and displayed as a percent predictive value indicator of the patient’s respiratory health.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -30 / 45 5. The patient may remove the mouthpiece from their mouth and resume normal breathing once the breathing maneuver has been completed. 6. Feedback about the test will be displayed on the app screen. The patient will need to perform 2 more tests by repeating this breathing maneuver.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -31 / 45 their lungs by blowing as hard and fast as they can into the mouthpiece for at least 6 seconds without breaking the seal of their lips. The patient may use a nose clip to help them exhale through only their mouth during this maneuver. 7. Ask the patient, without breaking the seal of their lips, to now inhale completely filling their lungs. 8.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -32 / 45 6. Feedback about the test will be displayed on the app screen. 7. Once all tests have been satisfactorily completed, you will be able to view the session results on the results page of the app. 8. To end the spirometry session, remove and immediately dispose of the mouthpiece, turn off device, clean the device body (please refer to section 8.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -33 / 45 After each test session,a quality grading will be displayed on the app to provide information about how well the breathing maneuver was performed, and if the results are acceptable or not. Grading of the FVC and FVL tests in children and adults, according to the American Thoracic Society guidelines.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -34 / 45 8. Maintenance of the Spirohome® Clinic 8.1 Calibration-check Due to the ultrasound-based technology for air flow analysis, routine calibration of the Spirohome® Clinic is not necessary. However, it is advised by the American Thoracic Society (ATS) that periodic calibration-checks of spirometers are performed.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -35 / 45 2. Insert a Spiroway® disposable mouthpiece into the Spirohome® Clinic device, and attach a Spirohome® adaptor for connection to the calibration syringe. 3. Check that the piston of the calibration syringe is fully inserted. 4. Attach the Spirohome® Clinic device to the nozzle of the calibration syringe. 5.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -36 / 45 2. Cleaning the Spirohome® Clinic Remove and dispose of the Spiroway® disposable mouthpiece from the Spirohome® C linic body if it is inserted. Use a high-level disinfectant (chlorine-based) and wipe for 30 seconds all accessible surfaces of both the device and device cap to remove all visible contaminants as shown below.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -37 / 45 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. Wash hands thoroughly after performing a cleaning procedure, and before handling the cleaned components again for packing and storage.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -38 / 45 device will not turn on and a ‘beeping’ sound will notify the operator. The batteries of the device should be removed if the device is not going to be used for more than a month. Instructions for battery replacement 1. Remove the Spiroway® d isposable mouthpiece from the device. 2. Remove the battery cover by sliding it as shown. 3.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -39 / 45 4. Place the new batteries in the correct orientation. 5. Slide the battery cover back to the closed position. 6. Insert the Spiroway® d isposable mouthpiece in the right orientation. The device is now ready to use. Spirohome® Clinic User Manual Rev.00 Feb 2019 İnofab Sağlık Teknolojileri A.Ş.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -40 / 45 9. 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.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -41 / 45 10. Appendix 10.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -42 / 45 Table 1: Emission table for IEC 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic emissions Spirohome® b attery-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 - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -43 / 45 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 environments.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -44 / 45 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 environments.
SPIROHOME® FDA DOSSIER USER MANUAL - CLINIC SPIROHOME® Document No Publication Date Revision Number Revision Date Page SUS-FDAD2 08.03.2019 00 -45 / 45 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.
