LivaNova 60-03-00, Руководство по обслуживанию

Страница: 7 / 82

SCPC System • Safety
CP_SEM_60-03-00.002 7
2 Safety
2.1 Approvals
Like development and manufacturing, service must also be conducted in accordance with the following
standards and legal regulations:
The SCPC System is a medical device, class IIb (MDD 93/42/EEC). A Declaration of Conformity has been
issued for the SCPC System.
2.2 Regulations and safety instructions
2.2.1 Intended use
!
◗
In accordance with the applicable regulations, the SCPC System is used for operating the Stöckert
Centrifugal Pump System (SCP System).
Instructions for use
◗
Any use beyond this specification is not as intended. LIVANOVA DEUTSCHLAND GMBH will not
assume any liability for any damage resulting from such use. The intended use 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 accept 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 also applies if
the operator’s duty to take due care has not been specifically expressed to the user.
2.2.2 Contraindications
◗
There are no known contraindications for the SCPC System. The attending physician is solely
responsible for the use of the system.
– This device complies with the requirements of
EU Directive 93/42/EEC of the European Council for
Medical Devices.
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