Planar C3 Reference Manual page 4

QUICK LINKS
Contents
Index
Regulatory Compliance
Product Information
Warranty
GETTING STARTED
About the Display
Package Contents
Identify Components
Position Display
Desk Stand Features
INSTALLING THE DISPLAY
Set DIP Switch
Install Display Controller
Connect Video and Power
Install Display Driver
Change Display Properties
Dome CXtra Software
APPENDIXES
Troubleshooting
Specifications
LED Status Lights
Single Desktop
USB Connection
Component Removal
Power Management
Palette Options
Regulatory Compliance
United States/European Union/Canada
These displays have 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 displays, 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 displays were 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
mode of operation is continuous. 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.
The applicable safety standards for an MDD Class I display are IEC/EN 60601-1:1990 along with
Amendments 1 and 2. To help the medical device designer evaluate the suitability of these displays,
Planar has also conducted EMC testing to IEC 60601-1-2 as it can be applied. The display with its
Dome C3i Display
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