64
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment
–
guidance
Electrical fast
transient/burst
IEC 61000-4-4
+/-2 kV for power
supply lines
+/-1 kV for
input/output lines
+/-2 kV for power
supply lines
+/-1 kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Note
• If the device is interfered by power or signal cable, image quality
may be reduced or abnormally displayed. Such kind of interference
images could be easily identified and differentiated from the
physiological characteristics of patient and longer clinical time
consumed but wouldn’t have any diagnostic accuracy issue.
• If there is a certain frequency of image interference, there is a need
of isolation or filtering of the RF signal.
