BDDF00171 Issue 4
36/39
BD Alaris™ MRI Capsule
Electromagnetic Emissions
Electromagnetic Immunity
Guidance and Manufacturer’s Declaration
– Electromagnetic Immunity
The MRI Capsule is intended for use in the electromagnetic environment specified below .
The customer or the user of MRI Capsule should assure that it is used in such an environment .
Immunity Test
EN 60601-1-2
Test Level
Compliance Level
Electromagnetic Environment –
Guidance
EN 61000-4-2
Electro-Static Discharge (ESD)
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 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% .
EN 61000-4-4
Electrical Fast Transient, Burst
(EFT) (Note 2)
± 2 kV at 100 kHz
repetition frequency
for Input a .c . power
ports
± 2 kV at 100 kHz
repetition frequency
for Input d .c . power
ports
± 1 kV at 100 kHz
repetition frequency
for Signal input/
output ports
± 2 kV at 100 kHz
repetition frequency
for Input a .c . power
ports
± 2 kV at 100 kHz
repetition frequency
for Input d .c . power
ports
± 1 kV at 100 kHz
repetition frequency
for Signal input/
output ports
AC power quality should be that
of a typical commercial or hospital
environment .
EN 61000-4-5
Power Line Surge
(Note 2)
± 0 .5 kV, ± 1 kV
Line-to-line for Input
Power Ports
± 0 .5 kV, ± 1 kV,
± 2 kV Line-to-
Ground for Input
Power Ports
± 2 kV Line-to-ground
for Signal input/
output
± 0 .5 kV, ± 1 kV
Line-to-line for Input
Power Ports
± 0 .5 kV, ± 1 kV,
± 2 kV Line-to-
Ground for Input
Power Ports
± 2 kV Line-to-ground
for Signal input/
output
AC power quality should be that
of a typical commercial or hospital
environment .
EN 61000-4-8
Power Frequency Magnetic
Field (50/60 Hz)
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment .
EN 61000-4-11
Voltage Dips, Short
Interruptions
(Note 2)
0 % UT;
0 .5 cycle at 0°, 45°,
90°, 135°, 180°, 225°,
270° and 315°
0 % UT;
0 .5 cycle at 0°, 45°,
90°, 135°, 180°, 225°,
270° and 315°
AC power quality should be that
of a typical commercial or hospital
environment .
If the user of the MRI Capsule requires
continued operation during AC Power
interruptions, it is recommended that
the MRI Capsule be powered from
an uninterruptible power supply or a
battery .
The MRI Capsule does employ an
internal short duration battery .
0 % UT; 1 cycle
Single phase: at 0°
0 % UT; 1 cycle
Single phase: at 0°
70 % UT;
25/30 cycles
Single phase: at 0°
70 % UT;
25/30 cycles
Single phase: at 0°
0 % UT;
250/300 cycle
0 % UT;
250/300 cycle
Note 1 –
U
T is the AC Power voltage prior to application of the test level .
Note 2 – Performed at the Minimum and Maximum Rated Input Voltage .
Note 3 – BD recommends using signal cables of less than 3 metres in length and this requirement is applicable only if signal cables are
3 metres or more in length . (EN 60601-1-2:2002, Clause 36 .202 .4)
