Evoke
®
SCS System Clinical Manual
CLIN-UMAN-005175
Revision: 9.00
Page 92 of 101
Table 20.5: 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.
Caution:
Portable and mobile RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer to any part of the Evoke
SCS System, including the cable, than the recommended separation distance stated below
(0.3 m, 12 inches). Otherwise, degradation of the performance of this equipment could
result.
Caution:
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
Immunity Test IEC 60601 Test Level
Compliance Level
Electromagnetic
environment – guidance
Conducted RF
IEC 61000-4-6
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
The Charger power
adaptor functioned
correctly during the
test.
Not applicable for a
battery-powered
device.
The separation distance
between an interfering
RF transmitter and any
Evoke stimulator should
be greater than 0.3 m
and the maximum
power from the RF
transmitter should not
exceed 2 W or 28 V/m at
a distance of 0.3 m.
Radiated RF
IEC 61000-4-3
10 V/m 80 MHz to 2.7
GHz
80% AM at 1 kHz
3 V/m for professional
healthcare facility
environment or 10 V/m
for home healthcare
environment
Proximity
fields from RF
wireless
communicatio
ns equipment
Up to 28 V/m at 0.3 m
at specified
frequencies (refer
Table 9, IEC 60601-1-
2)
Tested at up to 28 V/m,
devices continued to
function during test.
