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Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Table 17.4: Electromagnetic immunity – radio frequency
The Evoke SCS System is intended for use in the electromagnetic environment specified
below. The doctor or the patient should ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part
of the Evoke SCS System, including the cable, than the recommended separation distance
stated below .
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity fields
from RF wireless
communications
equipment
CLIN-UMAN-002424
Document Reference:
Evoke™ Clinical Manual
30 A/m
50/60 Hz
IEC 60601 Test Level
3 Vrms 150 kHz to 80
MHz;
6 Vrms in ISM and
amateur radio bands
between 150 kHz and
80 MHz
80 % AM at 1 kHz
10 V/m 80 MHz to
2.7 GHz
80% AM at 1 kHz
Up to 28 V/m at 0.3m
at specified
frequencies (refer
Table 9, IEC 60601-1-
2)
Revision: 12.00
30 A/m
Compliance Level
The Charger power
adaptor functioned
correctly during the
test.
Not applicable for a
battery-powered
device.
3V/m for
professional
healthcare facility
environment or 10
V/m for home
healthcare
environment
Tested at up to 28
V/m, devices
continued to function
during test.
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical household,
commercial or
hospital
environment.
Electromagnetic
environment –
guidance
The separation
distance between an
interfering RF
transmitter and any
Evoke SCS should be
greater than 0.3m
and the maximum
power from the RF
transmitter should
not exceed 2W or
28V/m at a distance
of 0.3m.
Page 52 of 56
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