Instruction Manual

Evoke® SCS System User Manual
D101706 Rev 2.01 10 Jan 2022 Page 53 of 59
Table 15-12 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 cables, 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 the
battery-powered devices.
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.
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
communications
equipment
Up to 28 V/m at 0.3m at
specified frequencies
(refer Table 9, IEC
60601-1-2)
Tested at up to 28 V/m,
devices continued to
function during test.