Össur i-Digits Quantum, Instructions For Use Manual

Page: 11 / 231

11 10
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 |
Battery Powered
No Cables >3m
Surge
IEC 61000-4-5 Not applicable Not applicable
Battery Powered Not applicable
Battery Powered
Voltage dips,
short
interruptions
and voltage
variations on
power supply
IEC 61000-4-11 Not applicable Not applicable
Battery Powered Not applicable |
Battery Powered
No Cables >3m
Power frequency
(50/ 60 Hz)
magnetic field
IEC 61000-4-8 30 A/m 30 A/m
50/60Hz Battery Powered