Evoke
®
SCS System User Manual
0% residual voltage;
250/300 cycles
Interval between
Events
–
min. 10s;
Test cycle
–
3 times;
Power frequency
Power frequency
magnetic fields
should be at levels
characteristic of a
(50/60 Hz)
30 A/m
30 A/m
typical location in a
magnetic field
IEC 61000-4-8
50/60 Hz
typical household,
commercial or
hospital
environment.
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.
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
3 V/m for professional
should not exceed 2W or
10 V/m 80 MHz
healthcare facility
Radiated RF
28 V/m at a distance of
to 2.7 GHz
environment or 10 V/m
IEC 61000-4-3
0.3 m.
80% AM at 1 kHz
for home healthcare
environment
CLIN-UMAN-005176
Revision: 4.01
Page 48 of 53
