Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Page 18
Version: 7 | Release date: 14. July 2021
2.2
Intended Use
Spirostik Complete 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. 4.1.4 “System Construction and
Electrical Safety”)
In all cases, the Spirostik Complete 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
Complete 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 Complete. Personnel
must demonstrably have been given training in the function of
Spirostik Complete. 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 Complete may only be used for the duration of its
service life if the specifications are observed.
Any changes to Spirostik Complete, in particular unauthorised
modifications, are prohibited.
The Spirostik Complete 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 Complete 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.
