Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 70
Version: 8 | Release date: 16. August 2021
8
Servicing / Maintenance
For the Diffustik variant resp. when the "CO Diffusion" option is
added to the PFTstik variant, the work steps in the separate
IFU Add-on CO Diffusion also apply.
8.1
Duties of the Responsible Organisation
Responsible organisations of medical devices are obligated, in
accordance with the corresponding, applicable regulations, to
preserve the properties of this medical device assured by the
manufacturer over its whole service life. This also includes
carrying out regular and proper servicing as well as safety
checks at intervals recommended by the manufacturer carried
out by specialist personnel who have been authorised by the
manufacturer for the respective tasks.
The expected service life of Diffustik resp. the variant PFTstik is
8 years.
In its development, a great deal of value was placed on making
the servicing of all device components as simple as possible.
Only a little work is necessary to guarantee a fault-free operation
of the device.
However, to maintain a high quality of measurement results and
the safe operation, the manufacturer recommends having the
device safety and measurement precision checked by an
authorised specialist retail partner every 24 months.
These checks include:
• Visual check
• Electrical measurement
• Functional Check
