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GUIDANCE AND MANUFACTURER'S DECLARATION

Electromagnetic 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

IEC 60601 Test

Compliance

Test

Level

Conducted RF

3 Vrms

3 V

IEC 61000-4-6

150 kHz to 80

MHz

Radiated RF

3 V/m

IEC 61000-4-3

3 V/m

80 MHz to 2.5

GHz

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.

Electromagnetic Environment Guidance

Portable and mobile RF communications

equipment should be used no closer to any part

of Spinal Modulation Neurostimulation System,

than the recommended separation distance

calculated from the equation applicable to the

frequency of the transmitter.

The recommended separation distance is a

minimum of 0.2 meter for 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

Rated maximum output

power of transmitter

(W)

150 kHz to 80 MHz

0.01

0.12m

0.1

0.37m

1.17m

3.70m

100

11.70m

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.

(m)

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.12m

0.23m

0.37m

0.74m

1.17m

2.33m

3.70m

7.37m

11.70m

23.30m