Ossur RHEO KNEE XC Gebrauchsanweisung Seite 12

Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The customer or user of device should
assure that it is 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
lines IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Note: U is the a.c. mains voltage prior to application of the test level.
T
IEC 60601 Test Level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % U (>95 % dip in U
T T
0.5 cycle.
40 % U (60 % dip in U ) for 5
T T
cycles.
70 % U (30 % dip in U ) for
T T
25 cycles.
<5 % U (>95% dip in U ) for
T T
5 s.
3 A/m
Compliance Level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
) for <5 % U (>95 % dip in U
T
for 0.5 cycle.
40 % U (60 % dip in U
T
5 cycles.
70 % U (30 % dip in U
T
25 cycles.
<5 % U (>95% dip in U
T
5 s.
3 A/m
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%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
) Mains power quality should be
T
that of a typical commercial or
) for hospital environment. If the user
T
of the device requires continued
) for operation during power mains
T
interruptions, it is recommended
) for that the device be powered from
T
an uninterruptible power supply
or a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
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