Planar VitalScreen D6015TM, Руководство по эксплуатации

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4 Operations Manual (OM700-02)
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