Symbol Explanations, Regulatory Compliance

Symbol Explanations

Following are explanations of the symbols found on the monitor or power supply.

Indicates proof of conformity to applicable European Economic Community Council directives and to harmonized standards published in the official journal of the European Communities.

Tested and certified by CSA to C22.2 N0. 601.1-M1990. If this mark appears with the indicators “C” and “US” the product is certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.

Tested to comply with FCC Class B standards.

Indicates that the monitor has been designed to meet low radiation standards.

Consult accompanying documents.

Tested and certified by TÜV Rheinland in accordance with

EN60601-1.

Indicates protective earth ground.

For indoor use only.

Identifies the socket for headphones.

Regulatory Compliance

This monitor has been tested to comply with IEC/EN 60601-1 and IEC/EN 60601-1-2 by TÜV Rheinland and is certified by CSA International to medical standards C22.2 No. 601.1-M1990 (C US Mark).

Because many medical offices are located in residential areas, this monitor, in addition to the medical requirements, has also been tested and found to comply with the limits for FCC Class B computing devices in a typically configured system. It is the system integrator or configurer’s responsibility to test and ensure that the entire system complies with applicable EMC laws.

Planar Systems, Inc. has made great efforts to support the medical device industry, in particular medical device manufacturers and medical device system integrators. We offer state of the art color displays that are compliant with worldwide accepted medical device safety standards, and for the European market, CE-marked displays based on compliance with council directive 93/42/EEC – commonly referred to as the Medical Device Directive (MDD). The following is a summary of our qualification of these displays as it relates to compliance with the MDD.

The European Medical Device Directive requires that the intended use of a device be defined. The intended use of these displays is “to display alpha numeric, graphic and image data as inputted from any type of medical device.” These displays do not provide a measurement function in any way and it is the device/systems manufacturer’s responsibility to verify its function in the integrated device or system.

The display was classified as required by the MDD according to Annex IX of the directive and the MEDDEV guidance available at the time of classification. Because the display uses electrical energy and has no direct patient connections and – by itself – no medical utility, the display is

4	Operations Manual (OM700-02)