More – Planar VS15XAD-TR User Manual
Page 5
VS15 Display
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QUICK LINKS
GETTING STARTED
INSTALLING THE DISPLAY
USING THE CONTROLS
APPENDIXES
The applicable safety standards for an MDD Class I display are IEC/EN 60601-1:1900 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
power supply alone does not represent a functional medical device. Hence, Planar configured a
minimal operating system to exercise the display. The resulting data are made available to
interested parties.
This is informative data, not certification data. Certification data must be obtained by the device or
system integrator according to Article 12 of the MDD titled “Particular procedure for systems and
procedure packs.” Paragraph 2 clearly outlines the device or system integrator’s responsibility in
this matter.
In summary, Planar Systems, Inc. is CE-marking these displays under the Medical Device Directive,
which establishes compliance to the basic medical safety standards. However, EMC compliance can
only be accomplished in the configured medical device or system and is the responsibility of the
device or system manufacturer. Planar has the necessary documentation such as IEC 60601-1
notified body and other third-party test reports and certifications, a risk/hazard analysis, an
essential requirements checklist, and the Planar International Electrotechnical Commission (IEC)
declaration of conformity.
Planar Systems, Inc., located in Beaverton, Oregon, USA, is the manufacturer of these displays in
the meaning of the directive. As required by the MDD in Article 14, Planar Systems, Inc., not residing
in the European Economic Area (EEA), has a European representative, Planar Systems, Inc.—
Olarinluoma 9, P.O. Box 46, FIN-02201Espoo, Finland (phone + 358 9 420 01; fax +358 9 420 0200).
In the opinion of Planar Systems, Inc. registration required to put this device into commerce is the
responsibility of the medical device/system manufacturer, and Planar supports this requirement by
providing a European commission (EC) declaration of conformity. If Planar supplies a display to an
end user, rather than a device manufacturer, it is the end user’s responsibility to ensure continued
compliance with the MDD of the system in which the display is integrated.
For vigilance reporting as required under Article 10 of the MDD, Planar Systems, Inc. will provide
any information requested by competent authority to support any reported incident investigation
by such an authority.
European Union Declaration of Conformity for Medical Applications
A Declaration of Conformity has been filed for this product. For additional copies of the Declaration
of Conformity document, contact Planar Systems, Inc.