iii
VS17.4SXAD / CM17.4SXAD
(
020-0168-00B
)
Regulatory Compliance
VitalScreen CSR
This display has been tested and found to comply with IEC/EN 60601-1
and IEC/EN 60601-1-2 standards, and is certified to meet medical
standard C22.2 No. 601.1-M1990 (C US Mark).
The medical display, in addition to meeting medical requirements,
has been tested and found to comply with the limits for Federal
Communications Commission (FCC) Class B computing devices in
a typically configured system since many medical offices are located in
residential areas. It is the system integrator’s responsibility to test and
ensure that the entire system complies with applicable electromagnetic
compatibility (EMC) laws.
Planar Systems, Inc. has made great efforts to support the medical
device industry, in particular, medical device manufacturers and medical
device system integrators. We offer state-of-the-art color displays that are
compliant with worldwide accepted medical device safety standards, and
for 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.” 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
IEC/EN 60601-1:1900 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 are
made available to interested parties.
The data are 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.
