GA_Portio-Koagulator_E_150914.docx
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12 T
ECHNICAL
S
ERVICE AND MAINTENANCE
12.1 FREQUENCY OF MAINTENANCE
In order to avoid accidents due to aging or normal wear-and-tear, the unit including
accessories need to pass a regular function and safety test according to IEC 60601-1.
Annual maintenance is therefore required.
CAUTION!
Opening of the housing, any repairs, modifications and calibrations may
only be performed by the manufacturer or by personnel explicitly
authorized by the manufacturer!
12.2 INSPECTION BEFORE STARTING, AFTER CHANGES AND
AFTER REPAIRS
Testing prior to the first intended use, any modification and after maintenance is carried
out in accordance with DIN EN 62353 ("Medical electrical equipment
– Iteration-test and
test after repair of medical electrical equipment").
Following tests must be conducted in a regular interval:
Change Fuses when appropriate
Check mechanical condition of the unit including the accessories
Check the tight fit of all electrical equipment including the protective conductor
connection
Check the readability of all functionally important inscriptions and the nameplate
Check the availability of all necessary documentation (instructions for use)
Check the function of all controls, sockets and lights on the device
Check the protective conductor resistance according to DIN EN 62353:2008-08,
Section 5.3.2
Check the leakage according to DIN EN 62353:2008-08, Section 5.3.3.
12.3 SAFETY INSPECTION (REPEATED TESTS)
The safety checks are carried out according to DIN EN 62353 ("Medical electrical
equipment - Loop test and test after repair of medical electrical equipment"). The safety
test is the responsibility of the operator, but should regularly (12 month interval) be
carried out by the manufacturer or a person authorized by him.
The individual test points can be found in chapter 12.2.
