Ossur i-DIGITS Gebrauchsanweisung Seite 19

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
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
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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