Barco Clinical review MDRC-2124 사용자 설명서

 

 

 

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This display has been tested 
and found to comply with 
IEC/UL/EN 60601-1 and IEC 
60601-1-2 standards, and is 
certified to meet medical 

standard UL 60601-1 and CAN/CSA C22.2 No 601.1(C US Mark) which 
are related to electrical shock, fire and mechanical hazards only as 
shown on right UL mark on this page. 

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. 

Barco NV 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.