Ossur PROPRIO FOOT, Техническое руководство

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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.
emissions Test compliance electromagnetic environment – guidance
RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function. Therefore, its RF
emissions are low and are not likely to cause any interference in nearby electronic
equipment.
RF Emissions CISPR 11 Class B The device is 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.
Harmonics Emissions
IEC 61000-3-2
Class B
Voltage Fluctuations/
Flicker Emissions
vIEC 61000-3-3
Complies
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 iec 60601 Test level compliance level
electromagnetic environment –
guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 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%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge IEC 61000-4-5 ±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, Short
interruptions and
voltage variations on
power supply
lines IEC 61000-4-11
<5 % U
T
(>95 % dip in U
T
) for
0.5 cycle.
40 % U
T
(60 % dip in U
T
) for 5
cycles.
70 % U
T
(30 % dip in U
T
) for
25 cycles.
<5 % U
T
(>95% dip in U
T
) for
5 s.
<5 % U
T
(>95 % dip in U
T
)
for 0.5 cycle.
40 % U
T
(60 % dip in U
T
) for
5 cycles.
70 % U
T
(30 % dip in U
T
) for
25 cycles.
<5 % U
T
(>95% dip in U
T
) for
5 s.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the device requires continued
operation during power mains
interruptions, it is recommended
that the device be powered from
an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Note: U
T
is the a.c. mains voltage prior to application of the test level.