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12
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
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Not applicable
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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.
RF emissions
CISPR 11
Class B
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.
Harmonic emissions
IEC 61000-3-2
Not applicable
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Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not applicable
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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
IEC 60601
test level
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
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
Electrical fast transient/
burst
IEC 61000-4-4
Not applicable
Not applicable
Battery Powered
Not applicable
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No Cables >3 m
Surge
IEC 61000-4-5
Not applicable
Not applicable
Battery Powered
Not applicable
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Voltage dips,
short interruptions and
voltage variations on power
supply IEC 61000-4-11
Not applicable
Not applicable
Battery Powered
Not applicable
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No Cables >30 m
Power frequency
(50/ 60 Hz) magnetic field
IEC 61000-4-8
30 A/m
30 A/m
50/60 Hz
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Содержание i-Limb Quantum
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