Planar VitalScreen D6015TM, Руководство по эксплуатации

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Operations Manual (OM700-02) 5
classified according to Rule 12 as an MDD Class I device – component or accessory. The MDD
sets out that manufacturers of Class I medical devices or accessories shall satisfy the
requirements in regards to design and manufacturing controls, i.e. the applicable assessment
route to be used for CE-marking under the MDD and shall carry the CE-mark according to Annex
XII of the directive, with no notified body annotation.
The applicable safety standards for a MDD Class I display are IEC/EN 60601-1: 1990 along with
Amendments 1 & 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 do not represent a functional medical device. Hence, Planar
has configured a minimal operating system that exercised the display. The resulting data is made
available to interested parties.
This data 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 Planar’s EC 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 EEA, has a European Representative, Planar Systems, Inc. – Espoo, Finland.
It is the opinion of Planar Systems, Inc. that registration of putting into commerce is the
responsibility of the medical device/system manufacturer and Planar supports this requirement by
providing an EC declaration of conformity. If Planar supplies a display to an end user, rather than
a device manufacturer, it is the end users responsibility to assure continued compliance of the
system in which the display is being integrated with the MDD.
For Vigilance reporting as required under Article 10 of the MDD, Planar Systems, Inc. will
provide any information requested by a competent authority to support any reported incident
investigation by such an authority.
EU Declaration of Conformity for Medical Applications
A Declaration of Conformity has been filed for this product. A sample of this
document may be found in the addendum which accompanied this manual. For a copy
of the Declaration of Conformity document, please contact Planar Systems, Inc. and
request document number 001-0014-00 “Declaration of Conformity”.