Össur COLD RUSH Notice D'utilisation page 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 %
T
dip in U ) for
T
0.5 cycle.
40 % U (60 %
T
dip in U ) for 5
T
cycles.
70 % U (30 %
T
dip in U ) for 25
T
cycles.
<5 % U (>95%
T
dip in U ) for
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
<5 % U (>95 %
T
dip in U ) for 0.5
T
cycle.
40 % U (60 % dip
T
in U ) for 5 cycles.
T
70 % U (30 % dip
T
in U ) for 25
T
cycles.
<5 % U (>95%
T
dip in U ) for 5 s.
T
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 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
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
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