CARDIO LINE 4000 S/S MED/MED/SP/S SP
CARDIO LINE 4100 S/S MED/MED
Technical and visual modifications as well as misprints reserved -
© 2018
by ERGO-FIT GmbH & Co. KG
11 9
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 ERGO-FIT devices of the CARDIO LINE 4000/4100, 4000/4100 S, 4000/4100 S MED
and 4000/4100 MED series are classified as protection class I devices. The ERGO-FIT
devices of the CARDIO LINE 4000 SP and 4000 S SP series are classified as protection
class II 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 supply voltage must be generated by a separate power source as described in IEC
601-1. In this case such a part and the user must not be touched an the same time.
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.
