Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Page 18
Version: 6 | Release date: 14. July 2021
2.2
Intended Use
Spirostik 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 Spirostik 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 Spirostik 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 Spirostik. Personnel must
demonstrably have been given training in the function of
Spirostik. 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 Spirostik may only be used for the duration of its service life
if the specifications are observed.
Any changes to Spirostik, in particular unauthorised
modifications, are prohibited.
The Spirostik is not intended for the control of vital physiological
parameters where the nature of the change could lead to
immediate danger to the patient, e.g. changes in heart function,
respiration or central nervous system activity.
Any other than the described use is deemed improper use.
The responsible organisation of Spirostik 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.
