Regulatory compliance – Planar VS15XAD-TR User Manual
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VS15 Display
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QUICK LINKS
GETTING STARTED
INSTALLING THE DISPLAY
USING THE CONTROLS
APPENDIXES
Regulatory Compliance
This display has been tested and certified to international medical safety standards IEC/EN 60601-1
and IEC/EN 60601-1-2, and is certified to meet C22.2 No. 601.1-M90 (C US Mark).
Because many medical offices are located in residential areas, the medical display, in addition to
meeting medical requirements, has also been tested and found to comply with the limits for
Federal Communications Commission (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 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.
The display was classified as required by the MDD according to Annex IX of the directive and the
medical device (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 classified according to Rule 12 as an MDD Class I device-component or accessory. The
MDD states that manufacturers of Class I medical devices or accessories shall satisfy the
requirements in regard to design and manufacturing controls, that is, the applicable assessment
route to be used for CE-marking under the MDD, and it shall carry the CE mark according to Annex
XII of the directive, with no notified body annotation.