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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The Pulsante® SPG Microstimulator System is intended for use in the electromagnetic environment specified below. The customer
or user of the Pulsante® SPG Microstimulator System should assure that it is used in such an environment.
EMMISSIONS/IMMUNITY
TEST
TEST LEVEL
COMPLIANCE LEVEL
ELECTROMAGNETIC ENVIRONMENT
GUIDANCE
RF emissions - CISPR 11
Not applicable
Class B, Group 2
The Pulsante® SPG Microstimulator
System must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment
may be affected.
Conducted emissions -
CISPR 11
Not applicable
Class B, Group 2
The Pulsante® SPG Microstimulator
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.
Harmonic emissions - IEC
61000-3-2
Not applicable
Not applicable
Voltage fluctuations /
Flicker emissions - IEC
61000-3-3
Not applicable
Not applicable
Electrostatic discharge
(ESD) - IEC 61000-4-2
±
8 kV contact
±
15 kV air
±
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
±
2 kV for power supply lines
±
1 kV for input/output lines
Surge - IEC 61000-4-5
±
1 kV differential mode
±
2 kV common mode
±
1 kV differential mode
±
2 kV common mode
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 sec
<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 sec
Note: UT is the a.c. mains voltage prior to application of the
test level.
Power frequency - 50/60
Hz magnetic field - IEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
locations in a typical commercial or
hospital environment.
Conducted RF - IEC
61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
150 kHz to 80 MHz
The Portable and mobile RF
communications equipment should be
used no closer to any part of the
Pulsante® SPG Microstimulator
System, including cables, than the
recommend separation distance
calculated from the equation applicable
to the frequency to the transmitter.
Recommended separation distance
d = 1.167√P 150 kHz to 80 MHz
d = 1.167√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power
rating to the transmitter in Watts (W)
according to the transmitter
manufacturer, and d is the
recommended separation distance in
meters (m).
Field strength from fixed RF
transmitters, as determined by an
electromagnetic site survey (Note A),
Radiated RF - IEC 61000-
4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
80 MHz to 2.5 GHz
