User's Manual

21
Guidance and Manufacturer’s Declaration
E
LECTROMAGNETIC IMMUNITY
The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment specified
below. The customer or the user of the Spinal Modulation Neurostimulator System should assure that it is used
in such an environment.
Immunity IEC 60601
Test Level
Compliance
Level
Electromagnetic environment
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2 ± 6 kV
contact
± 8 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 for power supply lines
±1kVforinput/outputlines
Pass Mains power quality should be that
of a typical commercial or home
environment
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that
of a typical commercial or home
environment
Voltage dips, short
interruptions and
voltage variations on
power supply
input lines
IEC 61000-4-11
<5% UT (>95% dip in UT)
for 0.5 cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT (>95% dip in UT)
for 5 s
NOTE UT is the a.c. mains voltage
prior to application of the test level
.
Mains power quality should be that
of a typical commercial or home
environment
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial, hospital, or home
environment.
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