User`s guide

34 | Dome Sx Display User’s Guide, 020-0931-00 Rev. F
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 Sx line, models Dome S3, Dome S3c, and Dome
S6c are intended for use in displaying and viewing radiography images for
review, analysis, and diagnosis by trained medical practitioners. Dome Sx line,
model Dome S10 is intended for use in displaying and viewing radiography
images for review and analysis by trained medical practitioners, for use in
displaying and viewing radiographs of the breast for review and analysis by
trained medical practitioners, or for use in diagnostic and mammography
display systems. 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 S3, 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.
For Dome S6c, the display was classified as Class I medical device required by
MDD 93/42/EEC, according to Annex IX Classification Criteria rule 12.
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 S3c and Dome S10 each, 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 S3c and the Dome S10 are
Class IIa medical devices, and subject to Notified Body’s approval.