Planar D6015TM manual EU Declaration of Conformity for Medical Applications

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”.

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