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Table 17.3: 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 Evoke SCS System should ensure that it is
used in such an environment.
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge Immunity
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
CLIN-UMAN-002424
Document Reference:
Evoke™ Clinical Manual
IEC 60601 Test Level
± 8 kV contact
± 2kV, ± 4kV, ± 8 kV,
± 15kV air
± 2 kV gaseous
discharge at 100 kHz
repetition frequency
± 0.5 kV, ± 1 kV
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
Revision: 12.00
Compliance Level
±2 kV, ±4 kV, ±6 kV,
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
± 2 kV @100 kHz
repetition frequency
for power supply
lines to Charger
power adapter
± 0.5 kV, ± 1 kV
power supply line to
Charger power
adapter
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. 10s;
Test cycle – 3 times;
Electromagnetic
environment –
guidance
Floors should be
wood, concrete, or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%
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 power mains
interruptions, it is
recommended that
the Evoke Charger
power adapter be
powered from an
uninterruptible
power supply or a
battery.
Page 51 of 56
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