Össur i-LIMB WRIST Mode D'emploi page 11

Refer to further guidance below regarding the EMC environment in which the device should be used:
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
Battery Powered
Class B
Not applicable
Battery Powered
Not applicable
Battery Powered
Compliance level Electromagnetic environment – guidance
±8 kV contact Floors should be wood, concrete, or ceramic tile. If floors
±15 kV air 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 Not applicable Battery Powered
No Cables >3 m
Not applicable Not applicable
Battery Powered
Not applicable Not applicable
Battery Powered
No Cables >30 m
3 A/m Battery Powered
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.
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