CP5 • Safety
10 CP_SEM_60-00-60.001
2.2.2 General safety instructions
◗ The CP5 has been designed in accordance with the accepted safety standards using state-of-the-
art technology. Nevertheless, the patient, the user or property may be put at risk during operation.
!
◗ The CP5 may only be used and maintained by trained and qualified personnel.
◗ The CP5 may not be used near explosive materials.
Use in accordance
with regulations:
See chapter 2.2.1
on page 9
◗ The CP5 should only be used when in perfect working order. The device must be used in accordance
with its intended purpose, and the relevant safety and operating instructions must be observed.
◗ The operating instructions for the CP5 should be kept close to the device at all times. Incomplete or
illegible operating instructions must be replaced immediately.
◗ The following also applies to the CP5 when used in combination with the S5 or C5 (overall system):
In accordance with the European Medical Device Directive (MDD) 93/42 EEC and the national
standards based on this directive, the CP5 must be subjected to a regular maintenance inspection
by an authorised service technician. The inspection must be carried out on the overall system after
every 1000 operating hours or at least every 12 months, whichever comes first. The regular
maintenance inspection of the CP5 is carried out together with the regular maintenance inspection
of the overall system based on the operating hours of the overall system.
◗ In addition to the operating instructions, the relevant legal, general and any other binding
regulations concerning the prevention of accidents must be observed.
◗ In order to cover situations 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).
◗ An S5 or C5 (or a compatible system) is required in order to use the CP5. For firmware information,
see inside front cover and the separate operating instructions for the S5 or C5. Only authorised
service technicians are permitted to upgrade the relevant firmware.
◗ If you detect modifications affecting the safety or performance of the CP5 (when the system is not
being used in the OT): do not use the device and have it checked by an authorised service
technician immediately.
◗ Do not modify, alter or extend the CP5 unless the changes have been tested and approved by
LIVANOVA DEUTSCHLAND GMBH. LIVANOVA DEUTSCHLAND GMBH cannot assume liability or
responsibility for unauthorised modifications or changes.
◗ Keep the device clean! This will prevent malfunction caused by contamination..
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