User's Manual

19
GUIDANCE AND MANUFACTURER’S DECLARATION
Electromagnetic Immunity
The Spinal Modulation Neurostimulation System is intended for use in the electromagnetic
environment specied below. The customer or the user of the Spinal Modulation Neurostimulation
System should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of Spinal Modulation Neurostimulation System,
than 0.2 meter, based on transmitters of 80 MHz
to 2.5 GHz.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Recommended separation distances between portable and mobile RF communications
equipment and the Spinal Modulation Neurostimulation System
The Spinal Modulation Neurostimulation System is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the Spinal Modulation
Neurostimulation System can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the System.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12m 0.12m 0.23m
0.1 0.37m 0.37m 0.74m
1 1.17m 1.17m 2.33m
10 3.70m 3.70m 7.37m
100 11.70m 11.70m 23.30m
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and people.