Instructions for Use
Spirostik Blue
Serial no.: 2111xxxxx
Version: 7 | Release date: 02. August 2021
Page 13
2
Conditions of Use
Any other use of Spirostik Blue which is not described in this
IFU is deemed improper use. The responsible organisation of
Spirostik Blue 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 Blue 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 Blue is designed for use in the mouth, nose, upper
throat area, trachea and lungs of the patient (definition see
chapter 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 Blue, you can also carry out the examination
stated below.
Examination
Required option
Broncoprovocation
Provocation
(Bronchial Provocation Software
403680)