SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
33 / 44
A
At least 3 acceptable trials AND the
difference between the best VC values is
equal to or less than 150 mL.
B
At least 2 acceptable trials AND the
difference between the best VC values is
equal to or less than 150 mL.
C
At least 2 acceptable trials but the results are
not reproducible according to 'B'.
D
One acceptable test.
F
No acceptable test.
8. Maintenance of your Spirohome
®
Personal
8.1 Calibration-check
Due to the ultrasound-based technology for air flow analysis, routine calibration of your
Spirohome
®
Personal is not necessary. However, it is advised by the American Thoracic Society
(ATS) that periodic calibration-checks of spirometers are performed. To check the calibration of
your Spirohome
®
Personal, you may compare the results from your device with spirometry test
results you obtain from a clinic or spirometry laboratory.
If you believe that there is a problem with the calibration of the device, contact the manufacturer
immediately and do not perform tests with the device.
8.2 Cleaning and disinfection of the device
Proper cleaning and disinfection of your Spirohome
®
Personal is important for safety and
hygiene purposes. With regular cleaning, you can prevent the physical buildup of contaminants
on your device. A cleaning process must always precede a disinfection process. Disinfection
destroys any pathogens such as bacteria, viruses or other microorganisms that might still be
present on device surfaces after an initial cleaning process. Regular, thorough cleaning and
disinfection of your device protects both you and others from the potential transmission of
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
33/44
