bioMetric SpinalPak Tam Kılavuz - Sayfa 14

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Electromagnetic Compatibility

A. T he use of accessories, cables or replacement parts other than those supplied by Biomet may

result in increased emissions or decreased immunity of the equipment or system.

B. T his equipment should not be used adjacent to or stacked upon other equipment.

C. P ortable and mobile RF communications equipment can adversely affect the operation of

Medical Electrical Equipment.

D. I n the event this equipment interferes with the operation of other equipment, or experiences

interference from other equipment, to continue treatment, it will be necessary to move the

Biomet

SpinalPak

interference as indicated in Table 4.

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.

Emissions test

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic

emissions

IEC 61000-3-2

Voltage

fluctuations/

flicker emissions

IEC 61000-3-3

Non-invasive Spine Fusion Stimulator System away from the source of the

Guidance and manufacturer's declaration -

electromagnetic emissions

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

Compliance

The Biomet

System uses RF energy only for its internal function. Therefore,

Group 1

The Biomet

Class B

domestic establishments and those directly connected to the

Not applicable

Table 1

Electromagnetic environment - guidance

SpinalPak

its RF emissions are very low and not likely to cause any

interference in nearby electronic equipment.

SpinalPak

Non-invasive Spine Fusion Stimulator

System is suitable for use in all establishments, including

public low-voltage power supply network that supplies

buildings used for domestic purposes.

Non-invasive Spine Fusion Stimulator

SpinalPak