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