BDDF00171 Issue 4
37/39
BD Alaris™ MRI Capsule
Electromagnetic Emissions
Guidance and Manufacturer’s Declaration
– Electromagnetic Immunity – Life Support Equipment
The MRI Capsule is intended for use in the electromagnetic environment specified below .
The customer or the user of the MRI Capsule should ensure that it is used in such an environment .
Immunity Test
EN 60601-1-2
Test Level
Compliance Level Electromagnetic Environment – Guidance
EN 61000-4-6
Conducted
disturbances
induced by RF
fields
EN 61000-4-3
Radiated RF EM
fields
3 V
0 .15 MHz –
80 MHz
6 V in ISM bands
between
0 .15 MHz and
80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2 .7 GHz
80 % AM at 1 kHz
3 V
0 .15 MHz –
80 MHz
6 V in ISM bands
between
0 .15 MHz and
80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2 .7 GHz
80 % AM at 1 kHz
Portable and mobile RF communications equipment
should be used no closer to any part of the MRI Capsule,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter .
Recommended Separation Distance
3 .5
d = [-----] √P
V1
12
d = [-----] √P 80 MHz to 800 MHz
V2
12
d = [-----] √P 80 MHz to 2 .5 GHz
E1
23
d = [-----] √P 800 MHz to 2 .5 GHz
E1
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m) .
a
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey, b should be less than
the compliance level in each frequency range .
c
Interference may occur in the vicinity of equipment
marked with the following symbol:
Note 1 – At 80 MHz and 800 MHz, the higher frequency range applies .
Note 2 – These guidelines may not apply in all situations . Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people .
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2 .5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference
if it is inadvertently brought into patient areas . For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in these frequency ranges .
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy . To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered .
If the measured field strength in the location in which the MRI Capsule is used exceeds the applicable RF compliance level
above, the MRI Capsule should be observed to verify normal operation . If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the MRI Capsule .
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m .
