S5 System • Safety
SM-5811-0000.01 ENG
2.1
2
Safety
2.1
Approvals
Like development and manufacturing, service must also be conducted in conformance with the following
standards and statutes:
The S5 System is a medical product, class IIb (MDD 93/42). A Declaration of Conformity has been issued
for the S5 System.
2.2
Regulations and Safety Instructions
2.2.1
Use in Accordance with Regulations
!
◗
In accordance with the applicable regulations, the Stöckert S5 System is used to
perform, control
and monitor extracorporeal circulation
during an operation. Any use outside this specification is not
in accordance with the regulations and SORIN GROUP DEUTSCHLAND GMBH will not assume any
liability for damage in such a case. Use 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 regulations and employees’
health and safety regulations must be complied with. SORIN GROUP DEUTSCHLAND GMBH will not
accept any liability for damage due to non-compliance with these regulations.
◗
SORIN GROUP DEUTSCHLAND GMBH will not assume any liability for injuries and/or damage caused
by failure to observe the safety instructions or operating 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.
IEC 60601-1
– Medical Electrical Equipment: General Requirements
for Safety
IEC 60601-1-2:2001
– EMC (Electromagnetic Compatibility)
VBG
– Regulations for Accident Prevention
MDD
– Medical Device Directive
(EC Directive 93/42 EEC of 14 June 1993)
DIN EN ISO 13485
– Quality Assurance
– CE Label