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inofab SPIROHOME User Manual
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inofab SPIROHOME User Manual

Ultrasonic personal spirometer
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Prepared by
Reviewed by
Approved by
REVISION
DATE
NUMBER
00
24.02.2019
®​
Spirohome​
Personal User Manual
ODTÜ Teknokent / Silikon Blok K:1 No:15-A Çankaya / Ankara / Turkiye ​ ​ ​ w ww.spirohome​ . io
®​
SPIROHOME​
FDA DOSSIER
USER MANUAL - PERSONAL
SPIROHOME​
SPIROHOME​
ULTRASONIC SPIROMETER
The document will be signed after revision.
FUNCTION
Regulatory Affairs
Deniz SARP
Quality Assurance
Ahmet Gökdere
CEO
Merthan Öztürk
REVISION RECORD
COMMENTS
Initial Issue
Rev.00 Feb 2019
İnofab Sağlık Teknolojileri A.Ş.
Document No
Publication Date
Revision Number
Revision Date
®
Page
®
DATED
SUS-FDAD
24.02.2019
00
--
1 / 44
SIGNED
SIGNED
​ 1/44

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Summary of Contents for inofab SPIROHOME

  • Page 1 DATE COMMENTS SIGNED NUMBER 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 ​ ​ ​ w ww.spirohome​ . io ​ 1/44...
  • Page 2 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 ​ ​ ​ w ww.spirohome​ . io ​ 2/44...
  • Page 3 Bluetooth SIG, Inc. 1.5 Electromagnetic Compatibility ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 3/44...
  • Page 4 Tel: +90 ​ 3 12 988 0308 www.spirohome.io ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 4/44...
  • Page 5 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 ​ ​ ​ w ww.spirohome​ . io ​ 5/44...
  • Page 6 Spirohome​ Personal. ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 6/44...
  • Page 7 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 7/44...
  • Page 8 Spiroway​ reusable mouthpiece. ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 8/44...
  • Page 9 Disposal in compliance with Waste Electrical and Electronic Equipment Directive Temperature limit ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 9/44...
  • Page 10 Type BF of Medical Electrical Equipment 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 ​ ​ ​ w ww.spirohome​ . io ​ 10/44...
  • Page 11 · Quick start guide · Carrying pouch(d) ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 11/44...
  • Page 12 Personal Cap 01104 ®​ Spirohome​ Pouch 01509 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 12/44...
  • Page 13 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 13/44...
  • Page 14 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 14/44...
  • Page 15 (2) for one second to switch and select your Spirohome​ Personal from ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 15/44...
  • Page 16 LED indicators are consecutively flashing The device is switching on green ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 16/44...
  • Page 17 Dynamic resistance at 14 L/s Volume resolution 1 mL ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 17/44...
  • Page 18 Spiroway​ mouthpiece is Replace Spiroway​ damaged mouthpiece ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 18/44...
  • Page 19 Error Messages Message Possible Cause Solution ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 19/44...
  • Page 20 The best values obtained from the spirometry tests performed in one session is displayed ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 20/44...
  • Page 21 (shown) to start a new test. ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 21/44...
  • Page 22 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 22/44...
  • Page 23 /FEV​ .75​ 6​ FEV​ /FEV​ 1​ 6​ ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 23/44...
  • Page 24 1​ 6​ FIF​ 25-75​ FIVC* FIV​ 1​ ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 24/44...
  • Page 25 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 Teknolojileri A.Ş. ODTÜ Teknokent / Silikon Blok K:1 No:15-A Çankaya / Ankara / Turkiye ​ ​ ​ w ww.spirohome​ . io ​ 25/44...
  • Page 26 FIV​ Forced inspiratory volume after 1 second ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 26/44...
  • Page 27 FIF​ 50​ Respiratory frequency Vital capacity ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 27/44...
  • Page 28 ​ f or at least 6 seconds (follow animated ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 28/44...
  • Page 29 4. To ready yourself, place the mouthpiece in your mouth (past your teeth and with ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 29/44...
  • Page 30 2. You must enter the environmental temperature as prompted by the app. ​ T he ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 30/44...
  • Page 31 11. Feedback about the test will be displayed on the app screen. You may need to repeat ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 31/44...
  • Page 32 Grading of the SVC test. Grade Criteria ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 32/44...
  • Page 33 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 33/44...
  • Page 34 You should disinfect the Spirohome​ ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 34/44...
  • Page 35 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 35/44...
  • Page 36 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 36/44...
  • Page 37 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 ​ ​ ​ w ww.spirohome​ . io ​ 37/44...
  • Page 38 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 ​ ​ ​ w ww.spirohome​ . io ​ 38/44...
  • Page 39 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 39/44...
  • Page 40 For details, please see the following tables: ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 40/44...
  • Page 41 Voltage fluctuations / flicker Not applicable purposes. emissions IEC 61000-3-3 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 41/44...
  • Page 42 IEC 61000-4-8 commercial or hospital environment. ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 42/44...
  • Page 43 Interference may occur in the vicinity of equipment marked with the following symbol: ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 43/44...
  • Page 44 ®​ 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 ​ ​ ​ w ww.spirohome​ . io ​ 44/44...