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GUIDANCE AND MANUFACTURER’S DECLARATION
Electromagnetic Emissions
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.
Guidance and Manufacturer’s Declarations
GUIDANCE AND MANUFACTURER’S DECLARATION
Electromagnetic Emissions
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.
Emissions test
Compliance Electromagnetic Environment – Guidance
RF Emissions 1
Group 2
The Spinal Modulation Neurostimulator System must emit
electromagnetic energy in order to perform its intended
function. Nearby electronic equipment may be affected.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class B
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
The Spinal Modulation Neurostimulator System is suitable for
use in all establishments, including domestic establishments
and those directly connected to the public low voltage power
supply network that supplies buildings used for domestic
purposes.
CISPR 14-1
Complies
The Clinical Programmer is not intended to be connected to
other equipment except the Programmer Charger.
