VQ OrthoCare BioniCare Knee System Manuel D'utilisation page 30

BioniCare Knee System
®
EMC Compliance Table (cont.)
Guidance and manufacturer's declaration - electromagnetic immunity
Immunity test
Surge
IEC 61000-4-5
Voltage dips, short
Interruptions and
voltage variations on
power supply input
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
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.
IEC 60601
Immunity test
Test Level
28
IEC 60601
Test Level
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
< 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
3 A/m
Compliance
level
Compliance level
Not Applicable
Not Applicable
Not Applicable
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.
Electromagnetic
environment -
guidance
Not Applicable
Not Applicable
Not Applicable