CentriMag
TM
Circulatory Support System Operation Manual (US)
Page 124 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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz,
outside ISM bands
a
10 Vrms
150 kHz to 80 MHz in
ISM bands
a
10 V/m
80 MHz to 2.5 GHz
3 Vrms
10 Vrms
10 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the System, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.2
√P
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
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 meters (m).
b
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
c
should be
less than the compliance level in each
frequency range.
d
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.
