Össur i-LIMB HAND Manual Tecnico página 23

Guidance and manufacturer's declaration – electromagnetic emissions
Össur Myoelectric Prosthetic Devices is intended for use in the electromagnetic environment specified below.
The customer or the user of the Össur Myoelectric Prosthetic Devices should assure that it each are 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
Guidance and manufacturer's declaration – electromagnetic immunity
Össur Myoelectric Prosthetic Devices are intended for use in the electromagnetic environment specified below.
The customer or the user of the Össur Myoelectric Prosthetic Devices should assure that each are used in such
an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
IEC 61000-4-11
Power frequency
(50/ 60 Hz) magnetic
field
IEC 61000-4-8
Compliance
Not applicable
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Class B
Not applicable
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Not applicable
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IEC 60601 Compliance level
test level
±8 kV contact ±8 kV contact
±15 kV air ±15 kV air
Not applicable Not applicable
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Not applicable Not applicable
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Not applicable Not applicable
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30 A/m 30 A/m
50 / 60 Hz
Electromagnetic environment - guidance
Össur Myoelectric Prosthetic Devices use RF energy only
for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.
Össur Myoelectric Prosthetic Devices are 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.
Electromagnetic environment – guidance
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Portable and mobile RF communications
equipment should be used no closer to any
part of the Össur Myoelectric Prosthetic
Devices, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter
Not applicable
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No Cables >3 m
Not applicable
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Not applicable
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No Cables >30 m
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