A.5
Safety regulations
A.5.1
Safety instructions
To protect the user, the Verband Deutscher Elektrotechniker e.V. (VDE, German
electrical engineering technician association) published special instructions for
electromedical devices and rooms used for medical purposes.
According to these instructions, devices connected to the grid must be equipped not
only with a reliable insulation of live parts but also with an additional protective measure
to protect the user against the transfer of the supply voltage to touchable metal parts.
For this purpose, VDE subdivides so-called protection classes.
Of the protection classes allowed for electromedical devices, in most cases protection
class I (protective measures with protective earth conductor) as well as protection
class II (protective measures without protective earth conductor but double insulation)
are used:
In protection class I devices, metal casing parts are connected with the protective
earth conductor of the grid through its earthing contact. In case of insulation failure,
the upstream circuit breaker will close the circuit.
The CYCLE models of the CARDIO LINE 400 are classified as protection class II
devices. The CYCLE models of the CARDIO LINE 400 MED are classified as protection
class I devices.
In the user's environment, parts of non-medical electric devices, which are touchable
after removing covers, connection devices etc. during routine maintenance, must
operate with a tension not exceeding 25 Volts of alternating current or 60 Volts of
direct current. In addition, the tension of the power supply must be produced by a
separate power source as described in IEC 601-1.
In this case, such a part of the device and the user must not be touched
simultaneously.
The use of electromedical devices is restricted to safety-relevant innocuousness
taking account of the state of the art, health and safety regulations and accident
prevention. Protective measures must be taken to avoid both direct and indirect
contact. Covers, coatings, insulation of energized parts in combination with protective
measures using protective earth conductors (in compliance with protection class I),
melting fuses as well as the observation of distances between devices are all part of
this.
Appendix
Technical and optical modifications as well as misprints reserved -
© 2011
by ERGO-FIT GmbH & Co. KG
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