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Maintenance and safety related inspection
HICO-VARIOTHERM 550
57
8.2 Safety related inspection
In order to maintain legal conformity and operational reliability as
per Medical Product Directive 93/42/EEC (appendix I,
point13.6.d) and MPBetreibV (§ 6(1)) the unit needs to be
subjected to a safety related inspection every 12 months. The
operator is solely responsible for the performance of this safety
related inspection. Based on the MPBetreibV (§ 6 (4) 1.+3.) this
safety related inspection must only be performed by Hirtz & Co.
KG or a qualified person. The safety related inspection covers at
least the following points:
•
Inspection of the device and application components for
external damage, wear, aging and legibility of displays and
inscriptions
•
Measurement of the PE resistance and the earth leakage
current according to the testing facility and manufacturer's
data
•
Inspection of all functions by following the operating
instructions
•
Inspection of all safety functions according to manufacturer's
data
•
Inspection of all sensors according to manufacturer's data (for
this purpose Hirtz & Co. KG provides a Service Manual for
authorised persons).