user manual

Operations Manual (OM705-00)
3
•
Use only the power adapter that has been tested and approved for use with
this monitor product. See “Ordering Information” on
page
22 for part
numbers.
Caution: The power adapter must be plugged into a GROUNDED
power outlet.
•
To clean the power adapter, use a cloth dampened with liquid cleaner on the
outside of the enclosure and cable only. Do not immerse the product in liquid,
or a safety hazard could arise during use.
•
Do not use the power adapter near flammable anesthetics.
Disposal Information
This monitor contains cold cathode fluorescent lamps, which contain a maximum
of 12 milligram (3 milligram per lamp) of mercury. Please follow local
ordinances or regulations for its disposal.
Regulatory Compliance
This monitor has been tested and found to comply with IEC/EN 60601-1 and
IEC/EN 60601-1-2 standards by TÜV Rheinland and is certified by CSA
International to meet medical standard C22.2 No. 601.1-M1990 (C US Mark).
Because many medical offices are located in residential areas, the medical
monitor, in addition to meeting medical requirements, has also been tested and
found to comply with the limits for Federal Communications Commission FCC)
Class B computing devices in a typically configured system. It is the system
integrator or configurer’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 manufacturers 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, i.e., 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.