Axium MN20600-02 Manual Del Usuario página 23

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
Electrostatic discharge
(ESD)
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
GUIDANCE AND MANUFACTURER'S DECLARATION
Electromagnetic Emissions
IEC 60601
Test Level
IEC 61000-4-2
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
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.
3 A/m
Compliance
Level
± 6 kV
contact
± 8 kV air
Pass
18
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 commercial or
home environment
Mains power quality
should be that of a
typical commercial or
home environment
Mains power quality
should be that of a
typical commercial or
home environment
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial,
hospital, or home
environment.