CentriMag
TM
Circulatory Support System Operation Manual (US)
Page 125 of 126
© 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
Guidance and manufacturer’s declaration – electromagnetic immunity
The CentriMag Circulatory Support System with 2
nd
Generation CentriMag Console and Mag Monitor is intended for
use in the electromagnetic environment specified below. The customer or the user of the System should assure that it
is used in such an environment.
Immunity Test
IEC 60601 test level
Compliance Level
Electromagnetic environment-guidance
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553
MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b
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 has been
incorporated into the formulae used in calculating the recommended separation distance for transmitters in these
frequency ranges.
c
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 System is used exceeds the applicable RF
compliance level above, the System should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the System.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the CentriMag Circulatory Support System
The CentriMag Circulatory Support System with 2
nd
Generation CentriMag Console and Mag Monitor is intended for
use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the System as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
outside ISM bands
d = 1.2
√
P
150 kHz to 80 MHz
inside ISM bands
d = 1.2
√
P
80MHz to 800
MHz
d = 1.2
√
P
800 MHz to 2.5
GHz
d = 2.3
√
P
0.01
0.12
0.12
0.12
0.23
0.1
0.38
0.38
0.38
0.73
1
1.2
1.2
1.2
2.3
10
3.8
3.8
3.8
7.3
100
12
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
