Specifications

Users Manual: MD-CP42AUPG-MED

Division Canvys

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 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 integrated medical power supply:

Alternation current input: 100 - 240V~, 50 - 60Hz, Power max. 350VA

This unit may only used in systems with connected protection earth