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Electromagnetic Compatibility

A. The 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. This equipment should not be used adjacent to or stacked upon other equipment.
C. Portable and mobile RF communications equipment can adversely affect the operation of
Medical Electrical Equipment.
D. In 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
®
Stimulator away from the source of the
interference as indicated in Table 4.
Guidance and manufacturer's declaration -
electromagnetic emissions
The Biomet
®
SpinalPak
®
Stimulator is intended for use in the electromagnetic
environment specified below. The customer or the user of the Biomet
should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic
emissions
Not applicable
IEC 61000-3-2
Voltage
fluctuations/
Not applicable
flicker emissions
IEC 61000-3-3
Table 1
®
SpinalPak
®
Stimulator
Electromagnetic environment - guidance
®
The Biomet
SpinalPak
®
Stimulator uses RF
energy only for its internal function. Therefore, its RF
emissions are very low and not likely to cause any
interference in nearby electronic equipment.
®
The Biomet
SpinalPak
®
Stimulator is suitable
for use in all establishments, including domestic
establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Guidance and manufacturers declaration - electromagnetic immunity
The Biomet
environment specified below. The customer or the user of the Biomet
Stimulator should assure that it is used in such an environment.
IEC 60601
Immunity test
Electrostatic
± 6 kV contact
discharge (ESD)
IEC 610004-2
Electrical fast
transient/burst
Not Applicable
IEC 61000-4-4
Surge
Not applicable
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
Not applicable
on power supply
input lines
IEC 61000-4-11
Power frequency
( 50/60 Hz )
Not applicable
magnetic field
IEC 61000-4-8
12
13
Table 2
®
SpinalPak
®
Stimulator is intended for use in the electromagnetic
Electromagnetic environment -
Compliance level
test level
Floors should be wood, concrete or
ceramic tile. If floors are covered with
Group 1
synthetic material, the relative humidity
± 8 kV air
Class B
Not applicable
Not applicable
Not applicable
®
SpinalPak
®
guidance
should be at least 30 %.