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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
Electrostatic
±8 kV contact
discharge (ESD)
±15 kV air
IEC 61000-4-2
Electrical fast
Not applicable
transient/burst
IEC 61000-4-4
Surge
Not applicable
IEC 61000-4-5
Voltage dips,
Not applicable
short
interruptions
and voltage
variations on
power supply
IEC 61000-4-11
Power frequency
30 A/m
(50/ 60 Hz)
magnetic field
IEC 61000-4-8
Compliance level
Electromagnetic environment – guidance
±8 kV contact
Floors should be wood, concrete, or ceramic tile. If
±15 kV air
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 |
Not applicable |
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No Cables >3m
Not applicable
Not applicable
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Not applicable
Not applicable |
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No Cables >3m
30 A/m
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50/60Hz
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