Instructions for Use
Spirostik Blue
Serial no.:
2111xxxxx
Page 18
Version: 7 | Release date: 02. August 2021
2.2
Intended Use
Spirostik Blue 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. 4.1.5 “System Construction and
Electrical Safety”).
In all cases, the Spirostik Blue 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 Blue
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 Blue. Personnel must
demonstrably have been given training in the function of
Spirostik Blue. 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 Blue may only be used for the duration of its
service life if the specifications are observed.
Any changes to Spirostik Blue, in particular unauthorised
modifications, are prohibited.
The Spirostik Blue 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 Blue 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.
