1000DF00480 Issue 2 46/48
Compliance (continued)
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the pump should assure that it is used in such an environment.
Immunity Test
IEC/EN 60601-1-2
Test Level
Compliance Level
Electromagnetic Environment – Guidance
IEC/EN 61000-4-2
Electro-Static Discharge (ESD)
±6 kV contact
±8 kV air
±8 kV contact
(Note 2)
±15 kV air (Note 2)
Floors should be wood, concrete, or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
If connector testing exemption is used, the following
symbol for ESD sensitivity appears adjacent to each
connector. “Caution – Do Not Touch”.
IEC/EN 61000-4-4
Electrical Fast Transient, Burst
(EFT) (Note 3)
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
N/A (Note 4)
Mains power quality should be that of a typical
commercial or hospital environment.
IEC/EN 61000-4-5
Power Line Surge
(Note 3)
±1 kV Line(s) to
Line(s)
±2 kV Line(s) to
Earth
±1 kV Line(s) to
Line(s)
±2 kV Line(s) to Earth
Mains power quality should be that of a typical
commercial or hospital environment.
IEC/EN 61000-4-8 Power
Frequency Magnetic Field
(50/60 Hz)
3 A/m
400 A/m 50 Hz
(Note 2)
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
IEC/EN 61000-4-11
Voltage Dips, Short
Interruptions, and Voltage
Variations
(Note 3)
<5 %
U
T (Note 1)
(>95 % dip in
U
T)
for 0.5 cycle
<5 %
U
T
(>95 % dip in
U
T)
for 0.5 cycle
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 or a battery.
The pump does employ an internal short duration
battery.
40 %
U
T
(60 % dip in
U
T)
for 5 cycles
40 %
U
T
(60 % dip in
U
T)
for 5 cycles
70 %
U
T
(30 % dip in
U
T)
for 25 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 5 sec
Note 1—
U
T
is the AC mains voltage prior to application of the test level.
Note 2—Compliance levels raised by IEC/EN 60601-2-24.
Note 3—Performed at the Minimum and Maximum Rated Input Voltage.
Note 4—CareFusion recommends using signal cables of less than 3 meters in length and this requirement is applicable only if signal cables are 3 meters
or more in length. (IEC/EN 60601-1-2:2002, Clause 36.202.4)
