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Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity test
IEC 60601
Test Level
Compliance level
Electromagnetic
environment -
guidance
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not Applicable
Not Applicable
Voltage dips, short
< 5 % U
T
Not Applicable
Not Applicable
Interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
(>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
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
Not Applicable
Not Applicable
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic immunity
The BioniCare Knee System is intended for use in the electromagnetic environment
specified below. The customer or the user of the BioniCare Knee System should assure
that it is used in such an environment.
Immunity test
IEC 60601
Test Level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communication
equipment should be used no closer to any
part of the BioniCare Knee System than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
