Instructions for Use
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
Version: 7 | Release date: 02. August 2021
Page 21
Patient
is a person undergoing medical treatment (check-up, initial
diagnosis as well as progress / treatment monitoring) to assess
their pulmonary exercise tolerance. The persons can be adults
without an age limitation as well as children form 4 years of age.
A requirement for carrying out the examination is the ability to
follow the instructions of the user.
2.2
Intended Use
Ergostik 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 Ergostik 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 Ergostik 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 ensure that only medically
trained specialist personnel (see chap. 2.1.3 “Definition of the
Groups of People”) operates Ergostik. Personnel must
demonstrably have been given training in the function of
Ergostik. 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 Ergostik may only be used for the duration of its service life if
the specifications are observed.
Any changes to Ergostik, in particular unauthorised
modifications, are prohibited.
