26 | Dome Ex Display
We offer state-of-the-art displays suitable to the European market, CE-marked
displays based on compliance with counsel directive 93/42/EEC—commonly
referred to as the Medical Device Directive (MDD). The following summarizes
our qualification of these displays as it relates to compliance with the MDD.
The European Medical Device Directive requires that the intended use of
the device be defined. Dome Ex line, model Dome E2cHB is intended for use
in the displaying and viewing of medical images for review, analysis, and
diagnosis by trained medical practitioners. Dome Ex line, model Dome E3 is
intended for use in the displaying and viewing of radiography images for
review, analysis, and diagnosis by trained medical practitioners. Dome Ex line,
model Dome E3cHB is intended for use in the displaying and viewing of
medical images for review and analysis by trained medical practitioners.
Dome Ex line, model Dome E5 is intended for use in the displaying and
viewing of medical images, including radiographs of the breast, for review
and analysis by trained medical practitioners. These displays do not
provide a measurement function in any way, and it is the device and
systems manufacturer’s responsibility to verify its function in the
integrated device or system.
For Dome E2cHB, Dome E3cHB, and Dome E5 each, the display was classified
as required by the MDD according to Annex IX of the directive and the
medical device (MEDDEV) guidance available at the time of classification.
Because the display uses electrical energy and has no direct patient
connections and—by itself—no medical utility, the display is classified
according to Rule 12 as an MDD Class I device, component, or accessory. The
MDD states that manufacturers of Class I medical devices or accessories shall
satisfy the requirements in regard to design and manufacturing controls, that
is, the applicable assessment route to be used for CE-marking under the
MDD, and it shall carry the CE mark according to Annex XII of the directive,
with no Notified Body annotation.
Furthermore, the applicable safety standards for an MDD Class I display are
EN 60601-1:2006 and IEC 60601-1:2005. To help the medical device designer
evaluate the suitability of these displays, NDSsi 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, NDSsi
configured a minimal operating system to exercise the display. The resulting
data are made available to interested parties.
For Dome E3, the display was classified as required by the MDD 93/42/EEC,
according to Annex IX Classification Criteria rule 10, dash three. The above
intended use for review, analysis, and diagnosis is a Class IIa medical device.
Thus, we believe the Dome E3 is a Class IIa medical device, and subject to
Notified Body’s approval.
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