safety, warnings, precautions, prohibitions
file: n:\article\cos14310m5-v1_06hpc-en\20120215_cos14310m5-v1.06hpc-en_manual_h-p-cosmos_running_machine.doc
© 2012 h/p/cosmos sports & medical gmbh [email protected] created 15.02.2012 printed 15.02.2012 page: 22 of 213
[4.E]
Instructions for safety and operation
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
[4.E1]
Electric safety / safety classes / degree of protection
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
M
(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
M
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. h/p/cosmos running machines have:
degree of protection against electrical shock: class I
M
degrees of protection provided by enclosures: IP 20
[4.E2]
Patient security according to VDE 0750 (IEC 60601-1) type B
R
applied part
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 device. At your h/p/cosmos medical device 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 60601-1 applied
part type B
R
. 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 and if the connected equipment is explicitly declared as compatible
by all relevant manufacturers.
[4.E3]
Potential equalization
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 medical h/p/cosmos running machines 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
2
cross-section [cos10223]
