Technical information
Users Manual: DFM19HBV
2007 Richardson Electronics GmbH
Division A.C.T. Kern
6
General Notes on Electrical Safety
Connecting medical electrical equipment to other medical electrical devices and/or other non medical
electrical devices, be it for diagnostic or therapeutic purposes or for monitoring, creates a medical
electrical system. The standard EN 60601-1-1 and cUL 60601 describes the requirements for these
systems.
These systems must be composed of devices that comply either with the standard EN 60601-1 and or
cUL 60601 or with the applicable IEC / ISO standard (PCs, for instance, must meet the requirements of
the standard IEC 60950) or that are equipped with additional safety features, such as a protective earth
conductor, isolating transformer or electrically isolated interface (e.g. optocoupler). This applies to
devices of protection class I or II. It is not permitted to integrate protection class 0 devices in medical
electrical systems.
In the patient environment, the following maximum enclosure leakage currents (current flowing
between two device enclosures or between the enclosure of a device and the protective earth
conductor) are permitted for medical devices:
normal condition: 0.1 mA
single fault condition: 0.5 mA (e.g. protective earth conductor interrupted)
Before putting the system into service for the first time, a specialist is required to check that these
values are not exceeded.
If the enclosure leakage current of a device or of the system exceeds the limit values stated above,
additional protective measures, such as connection to protective earth conductor, isolating
transformers or conductive castors, must be implemented to correct this problem.
Safety Information
DANGER:
Explosion Hazard – The display including the power supply is not designed for use in areas
of medical locations where an explosion hazard may occur.
In appropriate usage of flammable anesthetics, skin cleansing agents and disinfectants the
medical Displays of the DFM series can be used risk less in surgical rooms and intensive
care units.
It is not permitted to operate the devices in the presence of flammable substances (e.g. gas).
WARNING:
Shock Hazard — Use only following medical power supply:
Medical Power Supply Model Lien LE-0312B130W AC-Input: 100 – 240V~, 50 – 60Hz ,
DC-Output: +24V= / 5.41A
or Medical Power Supply Model Medi Power AD-2480MB, AC-Input: 100 – 240V~, 50 – 60Hz ,
DC-Output: +24V= / 3.33A