Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 13
2
Conditions of Use
Any other use of Diffustik resp. the variant PFTstik which is
not described in this IFU is deemed improper use. The
responsible organisation of Diffustik resp. the variant PFTstik
alone is liable for any direct or indirect damage resulting from
not adhering to these conditions. They are then solely
responsible for the fulfillment of the basic requirements of the
medical device and assumes complete product liability for the
whole system.
2.1
Intended Purpose
For the Diffustik variant, the separate IFU
Add-on CO Diffusion is additionally intended for the following
purposes.
The Diffustik resp. the variant PFTstik is a medical electrical
device. As a PC-linked PFT system, it is mainly intended to
determine lung volumes and airway resistances (Rint) in lung
function diagnostics in the clinical sector and by general
practitioners.
Diffustik resp. the variant PFTstik is designed for use in the
mouth, nose, upper throat area, trachea and lungs of the patient
(definition see chap 2.1.3 “Definition of the Groups of People”).
The Diffustik resp. the variant PFTstik and the Flow sensor may
only come into contact with intact skin and mucous membrane.
The standard version of the associated software enables the
Measurement of Spirometry, Flow / Volume, Airway Resistance
(Rint) as well as Pre / Post Examinations and Trend Analysis.
Using Diffustik resp. the variant PFTstik, you can also carry out
the examination stated below.
