Instructions for Use
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 13
2
Conditions of Use
Any other use of Ambistik PFT / Ambistik CPET which is not
described in this IFU is deemed improper use. The
responsible organisation of Ambistik PFT / Ambistik CPET
alone is liable for any direct or indirect damage resulting from
not adhering to these conditions (see chap. 2.1.1 “Definition
of the Groups of People”). 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
The medical device Ambistik PFT / Ambistik CPET is a PC-
based measuring device used to determine environmental
conditions: temperature, air humidity and pressure. From these
measured values the so-called BTPS factor (Body Temperature
Pressure Saturated) is calculated, which ensures standardised
measurement results by multiplication with the inhaled volume.
As an accessory for all products that measure air volumes, the
Ambistik PFT / Ambistik CPET is intended to enable the
automatic recording of ambient conditions.
The Ambistik CPET also contains a CO
2
sensor to correctly take
into account the CO
2
content of the ambient air in CPET
applications.
You can find more information in:
•
BLUE CHERRY® IFU for the general operation of the
software and carrying out the examination
