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Guidance and manufacturers declaration - electromagnetic immunity

The Biomet

SpinalPak

electromagnetic environment specified below. The customer or the user of the Biomet

Non-invasive Spine Fusion Stimulator System should assure that it is used in such an environment.

Immunity test

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

NOTE 1. At 80 MHz and 800 MHz, the higher frequency applies.

NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects, and people.

a F ield strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be

predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF

transmitters, an electromagnetic site survey should be considered. If the measured field strength in the

location in which the Biomet

the applicable RF compliance level, the Biomet

System device should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as reorienting or relocating the Biomet

Non-invasive Spine Fusion Stimulator System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.

Non-invasive Spine Fusion Stimulator System is intended for use in the

IEC 60601

Compliance level

test level

Not Applicable

3 V/m

80 MHz to 2.5

GHz

SpinalPak

Table 3

Portable and mobile RF communications equipment

1 V/m

should be used no closer to any part of the Biomet

SpinalPak

including cables, than the recommended separation

distance calculated from the equation applicable to the

where P is the maximum power output rating of the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey, a should be

less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment

Non-invasive Spine Fusion Stimulator System is used exceeds

SpinalPak

Electromagnetic environment -

guidance

Non-invasive Spine Fusion Stimulator System,

frequency of the transmitter.

Recommended separation distance

d = 3.5 √ P 80 MHz to 800 MHz

d = 7 √ P 800 MHz to 2.5 GHz

distance in meters (m).

marked with the following symbol:

Non-invasive Spine Fusion Stimulator

SpinalPak