QUICK LINKS
GETTING STARTED
USING THE BATTERY
MAINTAINING THE BATTERY
APPENDIXES
26
Invitium Battery System BAT-24CM
The applicable safety standards for an MDD Class I device are IEC/EN60601-1: 1990 along with
Amendments 1 and 2. To help the medical device designer evaluate the suitability of these
workstations, 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.
In summary, Planar Systems, Inc. is CE-marking these workstations 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, and essential requirements checklist, and Planar’s International
Electrotechnical Commission (IEC) declaration of conformity.
Planar Systems, Inc., located in Beaverton, Oregon, USA, is the manufacturer of these
workstations 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 its 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 workstation 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
workstation 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.
