SCP System • Safety
8
CP_SEM_60-00-00.002
2.2.2
General safety instructions
◗
The SCP System has been designed according to current state-of-the art technology and accepted
safety standards. Although this may be the case, danger may arise for the patient, the user or for
other equipment during operation.
◗
The SCP System must be operated and maintained by trained and qualified personnel only.
!
◗
The SCP System must not be operated near explosive substances.
Usage in accord-
ance with regula-
tions: See page 7.
◗
The SCP System may only be used when in fully operational condition and according to regulations
and the operating instructions.
◗
The operating instructions must be available close to the SCP System at all times. Incomplete or
illegible operating instructions must be replaced immediately.
◗
According to the
European Directive 93/42 EEC
and the national standards based on this directive,
the SCP System must be subjected to
a regular maintenance checks
by an authorised service
representative. The maintenance check for the SCP System must be performed after every
1000 operating hours
or
at least once every 12 months
(whichever comes first).
◗
In addition to the operating instructions, the relevant legal, general and binding regulations
concerning the prevention of accidents must be observed.
◗
In order to take situations into account which are clinic-specific and outside of normal routines,
e.g. certain working procedures, the operating instructions must be supplemented with relevant
instructions (supervision and registration requirements, etc).
◗
Personnel operating the SCP System must have acquainted themselves thoroughly with the
operating instructions prior to working with the machine.
◗
If you discover any safety-relevant modifications to the SCP System or its operating behaviour
(outside of OP mode): Do not use the device and have it checked out by authorised service
personnel.
◗
Do not perform any modifications or extensions to the device, unless they have been tested and
approved by LIVANOVA DEUTSCHLAND GMBH. LIVANOVA DEUTSCHLAND GMBH cannot otherwise
give any guarantee or assume liability.
◗
Keep the device clean. Doing so will prevent possible contact errors and faults due to dirt.
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