Evoke
®
SCS System Clinical Manual
CLIN-UMAN-005175
Revision: 9.00
Page 91 of 101
Table 20.4: Electromagnetic immunity – electrostatic discharge and mains power.
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.
Immunity Test IEC 60601 Test Level
Compliance Level
Electromagnetic
environment – guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
±2 kV, ±4 kV, ±6 kV, ±8
kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
Floors should be wood,
concrete, or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV gaseous
discharge at 100 kHz
repetition frequency
± 2 kV @100 kHz
repetition frequency for
power supply lines to
Charger power adapter
Mains power quality
should be that of a
typical household,
commercial or hospital
environment. If the user
of the Evoke Charger
power adapter requires
continued operation
during mains power
interruptions, it is
recommended that the
Evoke Charger power
adapter be powered
from an uninterruptible
power supply or a
battery.
Surge
Immunity
IEC 61000-4-5
± 0.5 kV, ± 1 kV
± 0.5 kV, ± 1 kV power
supply line to Charger
power adapter
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Voltage Dips:
0% residual voltage
for 0.5 cycle at 0 °, 45
°, 90 °, 135 °, 180 °,
225 °, 270 °, 315 °;
0 % residual voltage; 1
cycle, and
70% residual voltage;
25/30 cycles
Single phase: at 0°
Voltage Interruptions:
0% residual voltage;
250/300 cycles
Voltage Dips:
0% residual voltage for
0.5 cycle at 0 °, 45 °, 90
°, 135 °, 180 °, 225 °,
270 °, 315 °;
0% residual voltage for
1 cycle at 0 °;
70% residual voltage for
25 cycles at 0 °;
Voltage Interruptions:
0% residual voltage for
250 cycles at 0 °;
Interval between Events
– min. 10 s;
Test cycle – 3 times;
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
50/60 Hz
30 A/m
Power frequency
magnetic fields should
be at levels
characteristic of a typical
location in a typical
household, commercial
or hospital environment.
