S5 System • Safety
2.2
SM-5811-0000.01
ENG
2.2.2
General Instructions
◗
The S5 System has been designed according to current state-of-the art technology and accepted
safety standards. However, danger may arise to the patient, the user or other equipment during
operation.
!
◗
The S5 System must not be used in the presence of explosive substances.
Use in accordance
with regulations:
See Chapter 2.2.1
on Page 2.1.
◗
The S5 System may only be used when the equipment is in perfect technical running order and when
it is used in accordance with the applicable regulations and the operating instructions. Be sure to
take note of cautions and warnings.
◗
The operating instructions must be available close to the S5 System at all times. Incomplete or
illegible operating instructions must be replaced immediately.
◗
According to the European Directive 93/42 EEC and the national standards based on this directive,
the S5 System must be subjected to a
regular maintenance check
by an authorised service
technician. The S5 System must be subjected to this maintenance check every
1000
operating hours
or at least every
12 months
, whichever comes first.
◗
In addition to the operating instructions, the relevant legal, general and binding regulations
concerning the prevention of accidents must be followed.
◗
In order to take into account situations which are clinic-specific and outside of normal routines, e. g.
certain working procedures, the operating instructions must be supplemented with relevant
instructions (supervision and registration requirements, etc).
◗
Persons operating the S5 System must familiarise themselves thoroughly with the operating
instructions before working on the machine!
Firmware informa-
tion:See Operating
Instructions
◗
The firmware installed in the device must correspond to the version numbers listed in the Operating
Instructions.
◗
Always switch off the S5 System using the main switch. Otherwise, the batteries may totally
discharge.
◗
If modifications affecting safety or performance are noticed when the S5 System is not in use, shut
down the machine immediately and have it checked by an authorised service technician.
◗
Do not execute any modifications or extensions to the machine unless they have been tested and
approved by SORIN GROUP DEUTSCHLAND GMBH, otherwise SORIN GROUP DEUTSCHLAND GMBH
cannot assume any liability or responsibility.
Routine Mainte-
nance: See
Operating
Instructions
◗
Keep the S5 System clean! This will prevent incorrect contact and faults due to dirt etc.