Planar CM17.4SXAD, VS17.4SXAD manual Regulatory Compliance, VitalScreen CSR

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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.

VS17.4SXAD / CM17.4SXAD (020-0168-00B)