Planar VS17.4SXAD, CM17.4SXAD manual VitalScreen CR, Manufacturer Declaration

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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.Espoo, Finland.

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. and request document number 001-0014-05 “Declaration of Conformity.”

VitalScreen CR

Manufacturer Declaration

This certifies that this product is in compliance with the EU Directive 89/336/EEC, using the EMC standards EN55022 (class B), EN50081-1 and EN50082-1. This product meets or exceeds EN60950, UL1950, and CSA 22.2 No. 950 safety requirements. This product has been tested and verified to meet CISPR 22 Class B requirements.

VS17.4SXAD / CM17.4SXAD (020-0168-00B)