User's Manual

22
Guidance and Manufacturer’s Declaration
E
LECTROMAGNETIC IMMUNITY
The Spinal Modulation Neurostimulation System is intended for use in the electromagnetic environment specified
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
Separation distance according to frequency of transmitter
m
Rated maximum
output power of
transmitter
W
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 reflection from structures, objects and people.