Biosense Webster nGEN - Page 26

Page 22
nGEN™ Pump User Manual
Table 8 – Electromagnetic Immunity
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment – Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2, ± 4, ± 8 &
± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8 &
± 15 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
5 kHz & 100 kHz
repetition
frequency
± 2 kV for power
supply lines
5 kHz & 100 kHz
repetition
frequency
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV
differential mode
± 2 kV common
mode
± 1 kV
differential mode
± 2 kV common
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% U
T
for 0.5
cycle
0% U
T
for 1 cycle
70% U
T
for 25
cycles
0% U
T
for 5 sec
0% U
T
for 0.5
cycle
0% U
T
for 1
cycle
70% U
T
for 25
cycles
0% U
T
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the pump requires continued operation during
power mains interruptions, it is recommended
that the pump be powered from an
uninterruptible power supply.
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 AC mains voltage prior to application of the test level. The pump was tested at 100 and
240 VAC.
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Release Date: 2/14/2024