inofab SPIROHOME, User Manual

Page: 31 / 44

SPIROHOME
​ ® ​
FDA DOSSIER
Document No SUS-FDAD
Publication Date 24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
​ ®
Revision Number 00
Revision Date --
Page 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. I ​ nhale and exhale ​ completely filling and emptying your lungs, ​ repeatedly ​ ,
uninterrupted
​
, without breaking the seal of your lips
​
for at least 12 seconds (follow
animated guide on app screen).
6. You may remove the mouthpiece from your mouth and resume normal breathing once
the breathing maneuver has been completed.
7. Feedback about the test will be displayed on the app screen.
8. Once the test has been satisfactorily completed, you will be able to view your session
results on the results page of the app.
9. 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 ​
®
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 app. ​ The
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 your ​ lips are tightly sealed
around the mouthpiece
​
and
​
inhale and exhale normally
​
, for 3-5 breaths.
5. When prompted by the app, ​ fully inhale and then fully exhale.
10. You may remove the mouthpiece from your mouth and resume normal breathing once
the breathing maneuver has been completed.
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 ​ ​ ​ www.spirohome ​ .io ​ 31/44