Össur i-LIMB Quantum Manual Del Usuario página 13

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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