Disposal Information, Regulatory Compliance

•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 TÜ V 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.

Operations Manual (OM705-00)