Planar Dome E4c - Manual (Page 28)

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 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-02201 Espoo, 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.
The supplier will make available on request, circuit diagrams, component
part lists, etc.
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.
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