LivaNova 60-00-00, Service Manual

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SCP System • Safety
CP_SEM_60-00-00.002 7
2 Safety
2.1 Approvals
Just as for development and production, the system must also be serviced in accordance with the
following standards and legal regulations.
2.2 Regulations and safety instructions
2.2.1 Usage in accordance with regulations
!
◗
The SCP System is solely intended for use with the Revolution
®
on and/or with a Stöckert/
Sorin HLM (S3/SC/S5/C5) or the SCPC System as a centrifugal pump during cardiopulmonary
bypass. Any use beyond this specification is not in accordance with the regulations and
LIVANOVA DEUTSCHLAND GMBH will not assume any liability for damage in such a case. Usage in
accordance with regulations also includes compliance with the operating instructions, as well as
repair and maintenance according to the maintenance instructions.
◗
Relevant accident prevention measures according to existing local policy and employees’ health
and safety regulations must be complied with. LIVANOVA DEUTSCHLAND GMBH will not assume
any liability for damage due to non-compliance with these regulations.
◗
LIVANOVA DEUTSCHLAND GMBH will not assume any liability for injuries and/or damage caused by
failure to observe the safety instructions or by the operator not taking due care. This applies even if
the operator’s duty to take due care has not been specifically expressed to the user.
IEC 62353 – Recurrent test and test after repair of
medical electrical equipment
IEC 60601-1-2 – EMC (Electromagnetic Compatibility)
MDD – Medical Device Directive 93/42 EEC
DIN EN ISO 13485 – Quality Management System
UVV – Regulations for Accident Prevention
UL 2601-1 – Standard for Medical and Dental
Equipment
GMP – Good Manufacturing Practice