SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
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.
5. 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,
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.
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
®
reusable
mouthpiece.
The Flow Volume Loop 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. 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
.io
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