Table 20. Electromagnetic Immunity
Immunity Test
EN/IEC 60601 Test Level Compliance Level
Electromagnetic Environment -
Guidance
Butterfly iQ
Butterfly iQ+/
iQ3
Butterfly iQ
Butterfly iQ+/
iQ3
Electrostatic
discharge (ESD)
EN/IEC 61000-4 -2
±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%.
Electrical
transients / bursts
EN/IEC 61000-4-4
Not applicable.
This device does not function on AC
power.
Not applicable.
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m@50Hz or 60Hz 3 orthogonal
orientations
30 A/m
50 and 60Hz
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
Conducted RF
EN/IEC 61000-4-6
3 V 0,15 MHz– 80 MHz
6 V in ISM bands between 150 kHz
and 80 MHz
80% AM at 1 kHz
3 V 0,15 MHz– 80 MHz
6 V in ISM bands between 150
kHz and 80 MHz
80% AM at 1 kHz
Portable and mobile RF
communications equipment should
be used no closer to any part
of the Butterfly iQ/ iQ+/ iQ3
Ultrasound System, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Equations and key recommended
separation distances are shown in
Separation Distances [97].
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a.
should
be less than the compliance level in
each frequency range.
b.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
10 V/m
80 MHz to 6
GHz
10 V/m
80 MHz to
2.7 GHz
10 V/m
80 MHz to 6
GHz
Voltage Dips Voltage
Interruptions
EN/IEC
61000-4-11:2004
N/A Only tested for
Butterfly iQ3:
0 %, 0.5 cycle At
0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0%, 1 cycle
70%, 25/30
cycles 0%
250/300 cycles
N/A Only tested for
Butterfly iQ3:
0 %, 0.5 cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315° 0%, 1
cycle 70%,
25/30 cycles
0% 250/300
cycles
The EUT was setup according to the
test plan and connected to a dropout/
variation simulator and the software
was set to perform Voltage Dips,
Variations and Interruptions Immunity
Test.
Proximity Magnetic
Fields Immunity
IEC
61000-4-39:2017
N/A Only tested for
Butterfly iQ3:
30 kHz CW @ 8
A/m
134.2 kHz, 2.1
kHz PM @ 65
A/m
13.56 MHz, 50
kHz PM @ 7.5
A/m
N/A Only tested for
Butterfly iQ3:
30 kHz CW @ 8
A/m
134.2 kHz, 2.1
kHz PM @ 65
A/m
13.56 MHz, 50
kHz PM @ 7.5
A/m
The EUT was placed on a non-
conductive table. The radiating coil
is placed parallel at a distance of
50 mm from the EUT surface. The
EUT performance was monitored for a
period of 10 seconds. This procedure
was repeated for each spot on the
EUT that are subject to illumination by
magnetic fields under normal use.
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 Butterfly
iQ/ iQ+/ iQ3 Ultrasound System is used exceeds the applicable RF compliance level above, the Butterfly iQ/ iQ+/ iQ3 Ultrasound 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 Butterfly iQ/ iQ+/ iQ3 Ultrasound System.
b.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Electromagnetic Conformance (EMC)
Specifications 96
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