Instructions for Use
Safestik
Serial no.: 2011xxxxx
Version: 4 | Release date: 14. July 2021
Page 13
2.2
Intended Use
Safestik can be operated in combination with dedicated
products of the manufacturer via the universal software platform
BLUE CHERRY®. (See chap. 4.1.3
“System Construction and Electrical Safety”)
In all cases, the Safestik 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 Safestik 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. 2.1.1 “Definition of the
Groups of People”) operates Safestik. Personnel must
demonstrably have been given training in the function of Safestik.
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 Safestik may only be used for the duration of its service life if
the specifications are observed.
Any changes to Safestik, in particular unauthorised
modifications, are prohibited.
Any other than the described use is deemed improper use.
The responsible organisation of Safestik 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.