Planar VS15XAD Manuel D’Utilisation
Operations Manual (OM705-00)
4
The applicable safety standards for an MDD Class I display are IEC/EN 60601-
1: 1990 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 is made
available to interested parties.
1: 1990 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 is made
available to interested parties.
The 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.
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
International Electrotechnical Commission (IEC) declaration of conformity.
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
International Electrotechnical Commission (IEC) declaration of conformity.
Planar Systems, Inc. located in Beaverton, OR, 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
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.
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.
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
Applications
A Declaration of Conformity has been filed for this product. For additional
copies of the Declaration of Conformity document, please contact Planar
Systems, Inc. and request document number 001-0014-03 “Declaration of
Conformity.”
copies of the Declaration of Conformity document, please contact Planar
Systems, Inc. and request document number 001-0014-03 “Declaration of
Conformity.”