SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
19 / 44
Spirometry test was
performed incorrectly
Refer to How to Perform a
Lung Function Test in user
manual or refer video tutorial
on app
Spiroway
®
mouthpiece is
installed incorrectly
Refer to the user manual for
proper installation of
Spiroway
®
mouthpiece
Test does not start - Cannot
set up baseline
Direct air current in
environment
Close the cap of the
Spirohome
®
to avoid effects
of environmental flow
Place device on a flat surface
Remove causes of direct air
current e.g. air conditioner,
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 performed
After a forced exhalation,
take a short breath through
the spirometer before
breaking the seal of your lips
around the mouthpiece. The
device ends the
measurement when it detects
a small amount of negative
volume
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
.io
19/44
