SYNCHRO : Service & maintenance manual - rev. 7.1
Pagina 11.1
11.
FUNCTIONAL TEST MD MODELS
Every time maintenance and/or repairs are performed on a machine, it is necessary to carry out a
series of
mechanical
and
electrical tests
to ensure:
That the medical device is working properly;
That the medical device is working safely;
That the exercises are performed according to the biomedical specifications for which the
medical device was designed.
Technogym® ensures its own safety standards by means of the following tools and activities:
ISO 9001/2000 certification of the company;
Certification of the device in compliance with medical regulations 60601-1 and 60601-1-2;
Electrical testing of each device manufactured, according to the provisions of the
aforementioned standards;
Training of technical staff who perform technical service;
Use of checked and tested original Technogym® spare parts for all service operations;
CE Declaration of Conformity.
.
11.1.
ELECTRICAL SAFETY TEST
Based on the risk analysis carried out by the After Sale department regarding installation and
technical service, it is still necessary to use a tester to perform a safety test on the grounding ring.
This test must ensure a continuous earth connection
(resistance less than 4
Ω (Ohm))
between the
grounding pole of the mains lead
(connected to the machine)
and the points listed below:
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