Safety; Approvals; 2.2 Regulations And Safety Instructions; Use In Accordance With Regulations - SORIN GROUP S5 System Service Instructions Manual

2

Safety

2.1

Approvals

Like development and manufacturing, service must also be conducted in conformance with the following
standards and statutes:
IEC 60601-1
IEC 60601-1-2:2001
VBG
MDD
DIN EN ISO 13485
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.
SM-5811-0000.01 ENG
– Medical Electrical Equipment: General Requirements
for Safety
– EMC (Electromagnetic Compatibility)
– Regulations for Accident Prevention
– Medical Device Directive
(EC Directive 93/42 EEC of 14 June 1993)
– Quality Assurance
– CE Label
S5 System • Safety
!
2.1