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SPIROHOME

FDA DOSSIER

Document No

SUS-FDAD

Publication Date

24.02.2019

USER MANUAL - PERSONAL

SPIROHOME

Revision Number

Revision Date

Page

5 / 44

Table of Contents

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

2. Safety Information

2.1 Safety warnings and precautions
2.2 Restrictions on use and contraindications
2.2 Signs and symbols

3. About the Spirohome

Personal

3.1 Product description
3.2 The Spirohome

Personal System

3.3 Orderable accessories

4. Cybersecurity

4.1 About cybersecurity and your Spirohome

Personal

4.2 Passwords on the Spirohome

Personal platform

4.3 Software Updates
4.4 Data back-ups
4.5 Security breaches
4.6 Lost or stolen devices

5. Spirohome

Personal and smart device connectivity

5.1 Connectivity of the Spirohome

Personal platform

6. Operating the device

6.1 How to use the Spirohome

Personal: An overview

6.1 Operating environment
6.2 Setting up your Spirohome

Personal

6.3 Device indicators
6.4 Technical features of the Spirohome

Personal

6.5 Troubleshooting and error messages

7. Spirometry with your Spirohome

Personal

7.1 How to perform a spirometry test
7.2 Spirometry parameters
7.3 Types of breathing maneuvers
7.4 Understanding test quality

8. Maintenance and Cleaning of your Spirohome

Personal

8.1 Cleaning and disinfection of the device

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

.io

5/44

Summary of Contents for SPIROHOME

Page 1: ...ned after revision FUNCTION DATED SIGNED Prepared by Regulatory Affairs Deniz SARP Reviewed by Quality Assurance Ahmet Gökdere Approved by CEO Merthan Öztürk REVISION RECORD REVISION NUMBER DATE COMMENTS SIGNED 00 24 02 2019 Initial Issue 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 io 1 ...

Page 2: ...9 USER MANUAL PERSONAL SPIROHOME Revision Number 00 Revision Date Page 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 io 2 44 ...

Page 3: ... disease including but not limited to asthma chronic obstructive pulmonary disease and cystic fibrosis It is to be operated in the home setting by competent adult patients or caregivers of patients 1 3 About this user manual This user manual should be read by users of the device prior to operating the Spirohome Personal Store this user manual in a clean and easily accessible place for future refer...

Page 4: ...the FCC authorization to operate this equipment 1 6 Product Disposal This product should not be discarded as regular household waste but as electronic waste according to in accordance with local regulations and returned to a collection point of recycling electric and electronic devices Used batteries should be disposed of in designated battery recycling containers in accordance with local laws and...

Page 5: ...asswords on the Spirohome Personal platform 4 3 Software Updates 4 4 Data back ups 4 5 Security breaches 4 6 Lost or stolen devices 5 Spirohome Personal and smart device connectivity 5 1 Connectivity of the Spirohome Personal platform 6 Operating the device 6 1 How to use the Spirohome Personal An overview 6 1 Operating environment 6 2 Setting up your Spirohome Personal 6 3 Device indicators 6 4 T...

Page 6: ...required by local legislation The user must also report such incidents to the manufacturer Product and components Do not use the device if there is any damage is present on the device or its components upon removal from packaging and return the product to the supplier The Spirohome Personal must only be used with the original accessories specified and provided by the manufacturer Use of unspecifie...

Page 7: ...bers as the Spirohome Personal and Spiroway reusable mouthpiece is to be used by a single user only If a new user is to use the device ensure that the device is cleaned and disinfected see Maintenance section of this manual a new mouthpiece is used and a new account is created for the user on the app For patients who require assistance by competent caregivers special warnings regarding the Spiroho...

Page 8: ...eries if the Spirometry module is not to be used or is to be stored for a long period of time The Spirohome Personal should never be used with a charging smart device Make sure the smart device is unplugged from its charger before conducting a spirometry test Maintenance The user should periodically check to ensure that foreign bodies or impurities are not present on visible and accessible areas o...

Page 9: ...secting unstable aortic aneurysm recent current pneumothorax recent surgery including ophthalmic thoracic abdominal or cerebral aneurysms unstable angina recent myocardial infarction within one month recent pulmonary embolism undiagnosed chest conditions e g haemoptysis of unknown origin nausea vomiting severe respiratory distress physical limitations or cognitive impairment or dementia If you hav...

Page 10: ...imit 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 ODTÜ Teknokent Silikon Blok K 1 No 15 A Çankaya Ankara Turkiye www spirohome io 10 44 ...

Page 11: ... internal ultrasonic sensors detect the volume and speed of the expired air the device converts this information into spirometric data and displays it via the Spirohome application on a connected smart device The Spirohome app prompts and guides the user throughout the test for accurate data collection and display The Spirohome app can be downloaded on GooglePlay or on Apple s App Store The device...

Page 12: ...atible with Iphone 5s or later iPad Air Wifi or later and Ipod touch Spirohome Personal with Android device Requires Android API level 21 Lollipop 5 0 or later 3 3 Orderable accessories You can order new or replacement Spirohome Personal accessories from www spirohome io When placing your order please be sure to note the accessory reference number Accessory Name Reference Number Spiroway Reusable ...

Page 13: ...d difficult to be copied by unauthorized users The minimum requirements for a Spirohome password is using at least 8 characters at least one uppercase and one lower case alphabetic characters and at least one number 4 3 Software Updates In order to improve the Spirohome app features or incorporate new security features Spirohome software updates may be sent to your smart device Your device will be...

Page 14: ...r accounts 5 Spirohome Personal and smart device connectivity 5 1 Connectivity of the Spirohome Personal platform The Spirohome platform allows a range of devices to connect to a central network Several smart devices with the Spirohome Personal app can connect to and share information on a central database Access to a patient s information from different devices requires that the same user account...

Page 15: ...inaccurate readings if operated in the presence of strong electromagnetic sources such as electrosurgical equipment or in the presence of computed tomography CT equipment The Spirohome Personal conforms to EN 60601 1 EN 60601 1 11 EN 60601 1 2 and EN 300 328 As this device operates with RF technology it must be only as specified by the manufacturer it may to avoid interference to radio communicati...

Page 16: ... 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 Please see the following information for guidance on LED light indications LED Display Indication s None of the LEDs are on The device is switched off LED indicators are consecutively flashing green The device is switching on Spirohome Personal Us...

Page 17: ...All LEDs are flashing red There is a foreign object between the sensors TOF out of range error LEDs are consecutively flashing yellow Over the air connection is being established LED number 3 flashes red three times Battery low warning LEDs flash in reverse order and remain switched off The device is switching off 6 5 Technical features of the Spirohome Personal Flow Volume measurement method Ultr...

Page 18: ...urer Spirohome cannot connect to a smart device via Bluetooth Smart device is out of range Bring your smart device closer to the Spirohome device Smart device Bluetooth is disabled Enable Bluetooth of your smart device Bluetooth connection not working properly Your smart device will need Bluetooth version 4 0 or higher Find and select Spirohome Personal from list of detected devices Test results a...

Page 19: ... opened window fan etc Test does not start animated balloon is not moving Multiple possible causes Quit test and start new test Quit application and start a new test Switch device on and off again to reset Test Starts before you start blowing Vigorous handling of the device Keep device as stable as possible after starting a test Test does not end and keeps going Inhalation at the end of test not p...

Page 20: ...s are not obstructed Contact Manufacturer Error 08 Poor or no internet connection Check to ensure that smart device is connected to the internet For any other technical queries please call our customer service on 90 312 988 03 08 7 Spirometry with your Spirohome Personal 7 1 How to perform a spirometry test There are several types of tests and different parameter relating to lung function that can...

Page 21: ... 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 A click will be heard when the mouthpiece is inserted correctly all the way into the device 2 Load the Spirohome Personal App on your smart device and sign in Tap the plus button shown to start a new test Spirohome Personal User Manual Rev...

Page 22: ...bilize 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 Place the mouthpiece in your mouth past your teeth and form a tight seal around the mouthpiece with your lips Spirohome Personal User Manual Rev 00 Feb 2019 İnofab Sağlık Teknolojileri A Ş ODTÜ Teknokent S...

Page 23: ...of parameters actually displayed on the app will depend on the level of access to your test results that your Spirohome user account has been granted The Spirohome Personal records and displays the following spirometry test data Test Primary Parameters Unit FVC BEV L FEF 25 MEF 75 L s FEF 50 MEF 75 L s FEF 75 MEF 25 L s FEF 25 75 MMEF 25 75 L s FEF 50 FVC 1 s FET s FEV 75 L FEV 1 L FEV 3 L FEV 6 L...

Page 24: ... L FEF 25 MEF 75 L s FEF 50 MEF 50 L s FEF 75 MEF 25 L s FEF 25 75 MMEF 25 75 L s FEF 50 FVC FET s FEV 75 L FEV 1 L FEV 3 L FEV 6 L FEV 75 FVC FEV 1 FVC FEV 3 FVC FEV 6 FVC FEV 0 75 FEV 6 FEV 1 FEV 6 FIF 25 75 L s FIVC L FIV 1 L 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 io 24 44 ...

Page 25: ... RF 1 min MVVtime s Primary parameters are displayed as default on the results screen of the app after each spirometry session Secondary parameters are available in the See more parameters section of the app after each spirometry session The definition of the parameters detected and displayed by the Spirohome Personal is given below Spirohome Personal User Manual Rev 00 Feb 2019 İnofab Sağlık Tekn...

Page 26: ...EV 75 Forced expiratory volume after 0 75 seconds FEV 1 Forced expiratory volume after 1 second FEV 3 Forced expiratory volume after 3 seconds FEV 6 Forced expiratory volume after 6 seconds FEV 75 FVC Ratio of FEV 75 to FVC FEV 1 FVC Ratio of FEV 1 to FVC FEV 3 FVC Ratio of FEV 3 to FVC FEV 6 FVC Ratio of FEV 6 to FVC FEV 75 FEV 6 Ratio of FEV 75 to FEV 6 FEV 1 FEV 6 Ratio of FEV 1 to FEV 6 FET Fo...

Page 27: ...where 75 of the FVC remains to be expired MET 25 75 Time between 25 and 75 of the forced expired volume MIF 25 Maximal instantaneous forced inspiratory flow where 25 of the FVC remains to be expired MIF 75 Maximal instantaneous forced expiratory flow where 75 of the FVC remains to be expired MMEF 25 75 Mean mid expiratory flow from 25 to 75 of vital capacity MMEF FVC Ratio of mean mid expiratory f...

Page 28: ... Types of breathing maneuvers The breathing maneuvers involved in spirometry tests are physically demanding for most patients Please read the information below for the breathing maneuver you want to perform and continue with testing only if you feel well enough to do so Please cease testing if you feel dizzy or unwell The Forced Vital Capacity Test Breathing Maneuver 1 Ensure that your device is c...

Page 29: ...uality section of this user manual 6 Once all tests have been satisfactorily completed you will be able to view your session results on the results page of the app 7 To end the spirometry session remove mouthpiece turn off device and store you may use product pouch according to storage requirements until next use If the mouthpiece requires cleaning please refer to section 8 2 Cleaning the Spiroway...

Page 30: ...emove the mouthpiece from your mouth and resume normal breathing once the breathing maneuver has been completed 8 Feedback about the test will be displayed on the app screen You may need to repeat this breathing maneuver until you have acceptable test results However e nsure that you have rested between tests and feel well enough to continue For more information about test quality grading refer to...

Page 31: ...ve mouthpiece turn off device and store you may use product pouch according to storage requirements until next use If the mouthpiece requires cleaning please refer to section 8 2 Cleaning the Spiroway reusable mouthpiece The Slow Vital Capacity Test Breathing Maneuver 1 Ensure that your device is connected the test screen is ready 2 You must enter the environmental temperature as prompted by the a...

Page 32: ...ach test session a quality grading will be displayed on the app to inform you 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 Grade Criteria A 3 acceptable tests with repeatability within 0 150 L For age 2 6 0 100 L or 10 of the highest value wh...

Page 33: ...me Personal you may compare the results from your device with spirometry test results you obtain from a clinic or spirometry laboratory If you believe that there is a problem with the calibration of the device contact the manufacturer immediately and do not perform tests with the device 8 2 Cleaning and disinfection of the device Proper cleaning and disinfection of your Spirohome Personal is impor...

Page 34: ...e extra careful and gentle when cleaning the sensors to avoid any damage to them Perform cleaning at least once a week or whenever the device is visibly contaminated Wipe all accessible surfaces of the device and cap 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 Personal Never immer...

Page 35: ...ant 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 Personal User Manual Rev 00 Feb 2019 İnofab Sağlık Teknolojileri A Ş ODTÜ Teknokent Sili...

Page 36: ...igned to be used with the Spiroway reusable mouthpiece The mouthpiece is indicated for single patient use only The mouthpiece must not be used by more than one user to prevent the risk of cross contamination Thorough cleaning and disinfection of the device must be performed prior to use by a new user A new mouthpiece should be used for each user New mouthpieces can be purchased at www spirohome io...

Page 37: ...7 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 io 37 44 ...

Page 38: ... 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 ODTÜ Teknokent Silikon Blok K 1 No 15 A Çankaya Ankara Turkiye www spirohome io 38 44 ...

Page 39: ...nt or repair at the customer s expense to the authorized supplier or manufacturer Please provide with the returned product a clear written explanation of the fault or problem This warranty does not apply at the discretion of the manufacturer in the following cases Improper installation or operation of the device Use of the product for purposes other than those specified in this user manual Damage ...

Page 40: ...bility 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 For details please see the following tables Spirohome Personal User Manual Rev 00 Feb 2019...

Page 41: ... The Spirohome battery operated devices use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Spirohome devices are suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply ne...

Page 42: ...SD IEC 61000 4 2 2 kV 4 kV 6 kV 8 kV 15 kV 8 kV contact 2 kV air 4 kV air 8 kV air 15 kV air Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrostatic fast transient burst IEC 61000 4 4 N A NA Surge IEC 61000 4 5 NA NA Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4...

Page 43: ...loser to any part of the Spirohome devices including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the 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 to the transmitter manufacturer and d is the rec...

Page 44: ...ohome 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 p...

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