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
±6 kV contact;
±8 kV air
±6 kV contact;
±8 kV 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;
±2 kV for power
supply lines;
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s);
±2 kV line(s) to
earth
±1 kV line(s) to
line(s);
±2 kV line(s) to
earth
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
Short interruptions
and voltage
variation on power
supply input
voltage
IEC 61000-4-11
<5% U
T
(>95%
dip in U
T
) for
0.5 cycle
40% U
T
(60%
dip in U
T
) for 5
cycle
70% U
T
(30%
dip in U
T
) for 25
cycle
<5% U
T
(>95%
dip in U
T
) for 5
sec
<5% U
T
(>95%
dip in U
T
) for 0.5
cycle
40% U
T
(60% dip
in U
T
) for 5 cycle
70% U
T
(30% dip
in U
T
) for 25 cycle
<5% U
T
(>95%
dip in U
T
) for 5
sec
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
3 A/m
3 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.
