Revision 1.00 / LB-1070 – NeuroPort Biopotential Signal Processing System IFU
© 2021 Blackrock Microsystems, LLC
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Table 204–Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and
SYSTEMS that are not LIFE-SUPPORTING (refer to 60601-1-2).
Guidance and manufacturer’s declaration
—
electromagnetic immunity
The NeuroPort System is intended for use in the electromagnetic environment specified below. The customer or the user of the
NeuroPort system should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment — guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the NeuroPort
system, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
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).
Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey
a
should be
less than the compliance level in each frequency
range
b
.
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.
a
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 NeuroPort system is used exceeds
the applicable RF compliance level above, the NeuroPort system should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
NeuroPort system.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3V
/m
.
P
d
2
.
1
=
P
d
2
.
1
=
P
d
3
.
2
=
