Regulatory Compliance - Planar Dome E2 User Manual

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.
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.