Planar Dome EX manual Regulatory Compliance, Canada, European Union, United States

Regulatory Compliance

Canada, European Union, United States

This display has been tested and found to comply with IEC/EN 60601-1 and IEC/EN 60601-1-2 standards, and is certified to meet medical standard C22.2 No. 601.1-M1990 (C US Mark).

The medical display, in addition to meeting medical requirements, has been tested and found to comply with the limits for Federal Communications Commission (FCC) Class B computing devices in a typically configured system since many medical offices are located in residential areas. It is the system integrator’s responsibility to test and ensure that the entire system complies with applicable electromagnetic compatibility (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 counsel directive 93/42/EEC—commonly referred to as the Medical Device Directive (MDD). The following summarizes our qualification of these displays as it relates to compliance with the MDD.

The European Medical Device Directive requires that the intended use of the device be defined. The intended use of these displays is “to display alphanumeric, 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 and systems manufacturer’s responsibility to verify its function in the integrated device or system.