SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
34 / 44
infections resulting from contact with the device. Be sure to wash your hands with soap before
and after each use of the device.
The cleaning procedure and disinfection process is described below:
1.Before beginning the procedure wash hands thoroughly with soap and water.
2. Cleaning the Spirohome
®
Personal
Remove the Spiroway
®
reusable mouthpiece from the Spirohome
®
Personal body if it is
inserted. Use a high-level disinfectant (chlorine-based) and wipe for 30 seconds all accessible
surfaces of both the device and device cap to remove all visible contaminants as shown below.
Please be extra careful and gentle when cleaning the sensors to avoid any damage to
them.
Perform cleaning at least once a week or whenever the device is visibly contaminated.
Wipe all accessible surfaces of the device and cap, using moderate pressure, as shown.
Caution!:
Care must be taken to prevent any excess liquids contained within the wipes from
entering the components of the Spirohome
®
Personal. Never immerse the product in water or
any other liquid solution.
3. Disinfecting the Spirohome
®
Personal
After cleaning accessible surfaces of the device with a high-level disinfectant (chlorine-based)
wipe, use a second fresh wipe to wipe over all surfaces again with moderate pressure and
contact time as recommended by the wipe manufacturer. You should disinfect the Spirohome
®
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
34/44
