Instructions for Use
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 15
2.2
Intended Use
Ambistik PFT / Ambistik CPET can be operated independently
as a non-stationary device or in combination with all other
Geratherm® Respiratory GmbH products via the universal
software BLUE CHERRY®. (See chap. 4.1.3 “System
Construction and Electrical Safety”)
In all cases, the Ambistik PFT / Ambistik CPET is only intended
for use in closed, pleasantly temperature-controlled
(19 °C - 25 °C) rooms in a clinical area.
In the respective room, there must be neither flammable or
explosive gases, nor magnetic fields (e.g. MRI).
The following applies in general: The installation of Ambistik PFT
/ Ambistik CPET is only deemed safe and in line with intended
use when this is carried out in accordance with the details in
chap. 12.2 “Installation and Operating Conditions”.
The responsible organisation must ensuring that only medically
trained specialist personnel (see chap. 2.1.1 “Definition of the
Groups of People”) operates Ambistik PFT / Ambistik CPET.
These personnel must demonstrably have been given training in
the function of Ambistik PFT / Ambistik CPET. This also includes
a complete study of this IFU.
The manufacturer has determined the expected service life (see
chap. 11.1 "Expected Service Life") and the maintenance work
required for this (see chap. 8 "Servicing / Maintenance").
The Ambistik PFT / Ambistik CPET may only be used for the
duration of its service life if the specifications are observed.
Any changes to Ambistik PFT / Ambistik CPET, in particular
unauthorised modifications, are prohibited.
Any other than the described use is deemed improper use.
The responsible organisation of Ambistik PFT / Ambistik CPET
alone is liable for any damage resulting from not adhering to
these conditions.
Intended use also includes complying with all further information
and instructions in this IFU, without exception.
