CP5 • Safety
CP_SEM_60-00-60.001 9
2Safety
2.1 Approvals
Like development and manufacturing, service must also be conducted in conformance with the
following standards and statutes:
The CP5 is a class IIb medical device under the Medical Products Law (MDD 93/42). A Declaration of
Conformity has been issued for the CP5.
2.2 Regulations and safety instructions
2.2.1 Use in accordance with regulations
!
◗ The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for
use exclusively with the Sorin Revolution
®
, for speed-controlled pumping through the
cardiopulmonary bypass circuit.
Any use outside this specification is not in accordance with the regulations.
LIVANOVA DEUTSCHLAND GMBH will not assume any liability for any damage resulting from such
use. Usage in accordance with regulations also includes compliance with the operating
instructions and routine maintenance.
◗ The national regulations for accident prevention and all other internationally accepted health and
safety regulations must be complied with. LIVANOVA DEUTSCHLAND GMBH will not accept any
liability for any damage resulting from non-compliance with these regulations.
◗ LIVANOVA DEUTSCHLAND GMBH will not assume any liability for any injuries and/or damage
to property caused by failure to observe the safety or operating instructions or by the user not
exercising due care. This also applies if the user’s duty to exercise due care has not been stated
expressly.
– Declaration of Conformity
IEC 60601-1 – Medical Electrical Equipment-Part 1: General
Requirements for Safety
IEC 60601-1-2 – EMC (electromagnetic compatibility)
MDD – Medical Device Directive 93/42 EEC
DIN EN ISO 13485 – Quality Management System
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