EMC Guidance and Manufacturer’s Declaration 16-3
TABLE 2
GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IMMUNITY TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT-GUIDANCE
Electrostatic
Discharge(ESD)
IEC 61000-4-2
±8 kV contact;
±15 kV air
±8 kV contact;
±15kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30%.
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.
IEC 61000-4-5
line(s);
±2 kV line(s) to
earth
line(s);
±2 kV line(s) to
earth
Mains power quality should
be that of a typical
commercial or hospital
environment.
Short interruptions
and voltage
variation on power
supply input
voltage
IEC 61000-4-11
cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315°
0 % UT; 1 cycle
70% UT for
25/30 cycle
at 0°
0 % U T;
250/300 cycle
0 % UT; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle
70% UT for 25/30
cycle
at 0°
0 % UT; 250/300
cycle
Mains power quality should
be that of a typical
commercial or hospital
environment. If you require
continued operation during
power mains interruptions, it
is recommended that our
product be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 HZ)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: U
T
is the A.C. mains voltage prior to application of the test level.
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