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10. Additional Notes
51
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is
intended for use in the electromagnetic environment specied 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
±8 kV contact
discharges
±2 kV, ±4 kV, ±8
kV, & ±15
kV air discharges
±8 kV contact
discharges
±2 kV, ±4 kV, ±8 kV,
& ±15
kV air discharges
Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should be
at least 35%.
Electrical fast
Transient/burst
IEC 61000-4-4
±2 kV for power
supply lines and
±1 kV for input-
output lines;
both at 100 kHz
repetition rate.
±2 kV at 100 kHz
repetition rate for
Power Supply Lines
NA - Device does
not have user
I/O lines that are
longer than 3m in
length.
Mains power quality should
be that of a typical home or
hospital environment.
Surge
IEC 61000-4-5
±1 kV dierential
mode
±2 kV common
mode
±1 kV dierential
mode
N/A: Device is
Class 2 and does
not have earth
connection.
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 at
45 degree
increments
<5% U
T
(>95% dip
in U
T
) for 1 cycle
70% U
T
(30%
dip in U
T
) for 0.5
seconds
<5% U
T
(>95%
dip in U
T
) for 5
seconds
<5% U
T
(>95% dip
in U
T
) for
0.5 cycle at 45
degree increments
<5% U
T
(>95% dip
in U
T
) for 1 cycle
70% U
T
(30% dip in
U
T
) for 0.5 seconds
<5% U
T
(>95% dip
in U
T
) for 5 seconds
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.
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