User's Manual

18
GUIDANCE AND MANUFACTURER’S DECLARATION
Electromagnetic Emissions
The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic
environment specied 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 oors 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 eld
IEC 61000-4-8
3 A/m Power frequency
magnetic elds
should be at levels
characteristic of a
typical location in a
typical commercial,
hospital, or home
environment.