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Trilogy200 clinical manual
162
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
This device is intended for use in the electromagnetic environment specied below. The user of this
device should make sure 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
±8 kV contact
±15 kV air
Floors should be wood, concrete
or ceramic tile. If oors 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 supply mains
±1 kV for input/output
lines
Mains power quality should be
that of a typical home or hospital
environment.
Surge
IEC 61000-4-5
±1 kV dierential mode
±2 kV common mode
±1 kV dierential mode
±2 kV for common mode
Mains power quality should be
that of a typical home or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
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 cycles
70% U
T
(30% dip in
U
T
) for 25 cycles
<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
cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
Mains power quality should be
that of a typical home or hospital
environment. If the user of the
device requires continued operation
during power mains interruptions,
it is recommended that the device
be powered from an uninterruptible
power supply or a battery.
Power frequency (50/60
Hz) magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds
should be at levels characteristic
of a typical home or hospital
environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.