22 | Dome Sx 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. The intended use of these displays is “to display
alphanumeric, graphic, and image data as inputted from any type of medical
device.” Specifically, the Dome S3 and Dome S3c displays are intended for
use in displaying and viewing medical images for review and analysis by
trained medical practitioners. The Dome S10 display is intended for use in
displaying and viewing medical images for review and analysis by trained
medical practitioners, or intended for use in displaying and viewing
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.
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.
The applicable safety standards for an MDD Class I display are EN 60601-
1:1990 along with A1:1993, A12:1993, A2:1995, and A13:1996, as well as
IEC 60601-1:1988 along with A1:1991 and A2:1995. 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.
This 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.
