QUICK LINKS
GETTING STARTED
USING THE BATTERY
MAINTAINING THE BATTERY
APPENDIXES
25
Invitium Battery System BAT-24CM
Regulatory Compliance
This system has been tested and found to comply with IEC/CSA 601-1, UL 60601-1 and
CAN/CSA C22.2 No. 601.1 medical standards by CSA.
Because many medical offices are located in residential areas, the Invitium battery system, 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 responsibility of the system integrator or configurer 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 systems that are compliant with worldwide accepted medical device safety
standards, and for the European market, EC-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 MDD requires that the intended use of the device be defined. The intended use
of the Invitium workstation is “to display alphanumeric, graphic, and image data as inputted
from any type of medical device.” This system does 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 workstation 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 workstation uses electrical energy and has no direct patient connections and —
by itself — no medical utility, the workstation 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; in other words, the applicable
assessment route to be used for CD-marking under the MDD, and it shall carry the CD-mark
according to Annex XII for the directive, with no notified body annotation.
