36
Aerogen
®
Table 10. Guidance and manufacturer’s declaration – electromagnetic immunity for
the Aerogen Pro nebulizer system that is not life supporting
This Aerogen Pro nebulizer system is intended for use in the electromagnetic
environment specified below. The customer or the user of the Aerogen Pro nebulizer
system should assure that it is used in such an environment.
Immunity Test
IEC/EN 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
EN 61000-4-2:
2009
±8 kV contact
±15 kV air
±2, 4, 6 & 8 kV
contact
±2, 4, 6, 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
EN 61000-4-4:
2012
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
EN 61000-4-5:
2006
±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
EN 61000-4-11:
2004
<5 % Ut
(>95 % dip in
Ut) for 0.5 cycle
@ 0°, 45°, 90°,
135°, 180°, 225°,
270°, 315°
70 % Ut
(30 % dip in Ut)
for 25 cycles
<5 % Ut
(>95 % dip in Ut)
for 5 sec
<5 % Ut
(>95 % dip in
Ut) for 0.5 cycle
@ 0°, 45°, 90°,
135°, 180°, 225°,
270°, 315°
70 % Ut
(30 % dip in Ut)
for 25 cycles
<5 % Ut
(>95 % dip in Ut)
for 5 sec
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
the Aerogen Pro nebulizer
system requires continued
operation during power mains
operation, it is recommended
that the Aerogen Pro
nebulizer system be powered
from an uninterruptible power
supply or battery.
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