[3.D] Instructions For Safety And Operation; [3.D1] Electric Safety / Safety Classes; [3.D2] Patient Security According To Vde 0750 (Iec 601-1) Type B; [3.D3] Potential Equalization - h/p/cosmos 150/50 locomotion de med Operating Instructions And Service Manual

Instructions for safety and operation
[3.D]
The regulations mentioned in this chapter refer to the Federal Republic of Germany. For all other states take into
account the national legislation. If the running machine is a sports device (only c mark without 4-digit number), it must
not be connected with a medical product and must not be used for medical purposes. Due to higher safety requirements
medical instruments and devices are not allowed to be connected via extension cable and/or multiple plug socket with
the power supply, and a medical product must not be connected with a sports device either.
Disregard of warnings, disregard of intended and forbidden use, safety precautions and also
unauthorized or lack of maintenance and/or regular safety checks may lead to injuries or even
death and/or can damage the device and will result in loss of any liability and warranty
Electric safety / Safety classes
[3.D1]
In order to protect the subject (athlete and/or patient) and the personnel, the association of German electro-
technicians Inc, (VDE) has published special directives for medical used rooms and electro-medical devices.
Devices with a power supply therefore have to, in order to prevent the passing on of the mains voltage over to
touchable metal pieces, be equipped with not only a reliable isolation of the parts being under voltage but also
additional safety precautions. The VDE-association divides it into so called safety classes.
Of the, for electro-medical devices, licensed safety classes are mainly used the safety class I (i.e. safety
precautions with protective wiring), and the safety class II, (i.e. safety measures without protective wiring but with
double isolation): Devices of the safety class I are devices, where the metallic casing-parts are connected with the
protective wire of the line net via the safety contact. In the case of an isolation error the inserted fuse element
switches off.
Patient security according to VDE 0750 (IEC 601-1) type B
[3.D2]
If your h/p/cosmos device has a c mark with a 4-digit number (e.g. n) at the identification plate, it is a
medical product. At your h/p/cosmos medical product the patient is protected/isolated from the mains in
accordance with the safety standard referring to the requirements for leakage current values according to IEC 601-
1 type B. The connection of further mains-operated units to your h/p/cosmos-unit may cause that all the leakage
currents add and the safety of the patient is reduced. Due to this the connection of further units may only be
carried out on consultation with h/p/cosmos.
Potential equalization
[3.D3]
The connection of e.g. EDP units to the V24 / RS 232 / USB / LAN / FireWire interface of the computer or of other
independent measuring stations can only be carried out in medically utilized locations according to VDE 0107 / EN
ISO 60601-1-1. Parallel connection of the potential equalization ensures, that in case of insulation failure none of
the connected units exceeds a voltage of 10mV and thus endangers the patient.
For this purpose all of the h/p/cosmos units are equipped with a connection fixture with which the equipotent
conductor, being part of the standard equipment, is connected to the equipotent bus bar of the room.
Standard potential equalization cable (length 5m) with 4mm
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safety, warnings, precautions, prohibitions
2 cross-section [cos10223]
created 01.09.2008 printed 08.10.2008 page: 12 of 176