48
User Manual
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified 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
±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
±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 differential mode
±2 kV common mode
±1 kV differential 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 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
hospital or home environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.