SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
36 / 44
8.2 Cleaning the Spiroway
®
reusable mouthpiece
The Spiroway
®
reusable mouthpiece should be cleaned weekly or whenever it is visibly
contaminated. Clean the Spiroway
®
reusable mouthpiece by gently agitating it in water
containing dishwashing liquid, rinsing under clean water, and leaving upright on a lint-free cloth
to air-dry completely.
Do not insert the Spiroway
®
reusable mouthpiece to Spirohome
®
Personal device until it is
completely dry.
Replace the Spiroway
®
reusable mouthpiece:
-
every 3 months
-
if the user used the mouthpiece whilst having a bacterial or viral infection
-
if the filters are damaged
-
whenever a risk of cross-contamination is suspected (such as possible use of the
mouthpiece by other users)
Caution!: Risk of Cross-Contamination
Spirohome
®
Personal is designed to be used with the Spiroway
®
reusable mouthpiece. The
mouthpiece is indicated for
single-patient-use
only. The mouthpiece must not be used by more
than one user to prevent the risk of cross-contamination. Thorough cleaning and disinfection of
the device must be performed prior to use by a new user.
A new mouthpiece should be used for
each user.
New mouthpieces can be purchased at
. See the Orderable Accessories
section of this user manual for more information.
8.4 Replacing batteries
The Spirohome
®
Personal should be powered by a standard 1.5V AAA battery. The battery life
such batteries will be approximately 6-9 months, assuming daily use of the device. The battery
charge level is continuously monitored by the device. When battery charge level is low, the
device will not turn on and a ‘beeping’ sound will notify the user. The batteries of the device
should be removed if the device is not going to be used for more than a month.
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
36/44
