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Appendix
Technical and visual modifications as well as misprints reserved - © 2019 by ERGO-FIT GmbH & Co. KG
A.5 Safety Regulations
A.5.1 Safety Instructions
For user safety the VDE (Verband der Elektrotechnik e.V.) has issued special instructions
for medical premises and electro-medical devices.
According to these instructions, devices with mains connection 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 electro-medical 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 cardiowise devices of the XRCISE LINE MED are classified as protection class I
devices.
The use of electro-medical 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.
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