Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 13
2
Conditions of Use
Any other use of Spirostik which is not described in this IFU is
deemed improper use. The responsible organisation of
Spirostik 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
Spirostik is an electric medical device. It is a PC-connected
spirometer, intended to identify the static and dynamic lung
volume in pulmonary function testing in a clinical setting and by
established physicians.
Spirostik 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 standard version of the accompanying software permits
measurements for spirometry, flow / volume and MVV as well as
pre / post examinations and trend analysis.
Using Spirostik, you can also carry out the examination stated
below.
Examination
Required option
Bronchoprovocation
Provocation
(Bronchial Provocation Software
403680)
