SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
32 / 44
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.
12. Once all tests have been satisfactorily completed, you will be able to view your session
results on the results page of the app.
13. 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.
7.4 Understanding test quality
After each 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, whichever is greater
B
≥ 2 acceptable tests with repeatability within 0.150 L
For age 2-6, 0.100 L, or 10% of the highest value, whichever is greater
C
≥ 2 acceptable tests with repeatability within 0.200 L
For age 2-6, 0.150 L, or 10% of the highest value, whichever is greater
D
≥ 2 acceptable tests with repeatability within 0.250 L
For age 2-6, 0.200 L, or 10% of the highest value, whichever is greater
E
One acceptable test
F
No acceptable tests
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
.io
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