Planar VS15XAD-TR Quick Links, Contents Index Ordering Parts Product Information, Getting Started

QUICK LINKS

Contents

Index

Ordering Parts

Product Information

Regulatory Compliance

Warranty

GETTING STARTED

About the Display

Unpack Display

Identify Components

INSTALLING THE DISPLAY

Connect Power

Connect Video

Connect Audio

Connect Touch Screen

Power Management System

USING THE CONTROLS

Display Controls

OSD Menu

Function Menus

OSD Lockout

DDC Change

APPENDIXES

Technical Information

Troubleshooting

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.

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