SALUDA MEDICAL Evoke SCS User Manual page 48

Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Table 15-11 Electromagnetic immunity – radio frequency.
The Evoke SCS System is intended for use in the electromagnetic environment specified
below. The patient, doctor or any other user of the Evoke SCS System 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 cables, than the recommended separation distance
stated below.
IEC 60601 Test
Immunity Test
Level
3 Vrms 150 kHz
to 80 MHz;
6 Vrms in ISM
Conducted RF and amateur
IEC 61000-4-6 radio bands
between 150 kHz
and 80 MHz
80 % AM at 1 kHz
10 V/m 80 MHz
Radiated RF
to 2.7 GHz
IEC 61000-4-3
80% AM at 1 kHz
CLIN-UMAN-005176
Evoke® SCS System User Manual
0% residual voltage;
250/300 cycles
30 A/m
50/60 Hz
Compliance Level
The Charger power
adaptor functioned
correctly during the
test.
Not applicable for the
battery-powered
devices.
3 V/m for professional
healthcare facility
environment or 10 V/m
for home healthcare
environment
Revision: 4.01
Interval between
Events – min. 10s;
Test cycle – 3 times;
30 A/m
Electromagnetic
environment – guidance
The separation distance
between an interfering RF
transmitter and any
Evoke SCS should be
greater than 0.3 m and
the maximum power
from the RF transmitter
should not exceed 2W or
28 V/m at a distance of
0.3 m.
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical household,
commercial or
hospital
environment.
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