98 Biodex Medical Systems, Inc. © 2017
Table 12.4. Immunity Test Table
IEC 60601-1-2
Compliance
Level
Electromagnetic
Environment -Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air Test level
Contact ± 6 kV
Air ± 8 kV
Floor should be wood,
concrete or ceramic tiles.
If floor is covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transients/
burst
IEC 61000-4-4
± 2 kV for power
lines
± 1 kV for
input/output lines
Power ± 2 kV
Signal ± 1 kV
Mains power quality should be
that of a typical commercial or
hospital environment.
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV diff. mode
± 2 kV com. mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
< 5% UT (> 95% of
dip in UT for 1/2
cycle)
40% UT (60% of dip
in UT) for 5 cycle
70% UT (30% of dip
in UT) for 25 cycle
< 5% UT (> 95% of
dip in UT) for 5 sec
< 5% UT (> 95% of
dip in UT) for 1/2
cycle
40% UT (60% of dip
in UT) for 5 cycle
70% UT (30% of dip
in UT) for 25 cycle
< 5% UT (> 95% of
dip in UT) for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If a
better mains power quality is
required, it is recommended
that the Gait Trainer 3 is
powered from an
uninterruptible power supply.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
If image distortion occurs, it
may be necessary to position
the Gait Trainer 3 display
further from sources of power
frequency magnetic fields or to
install magnetic shielding. The
power frequency magnetic
field should be measured in
the intended installation
location to assure that it is
sufficiently low.
Conducted RF
IEC 61000-4-6
3 Vrms,
150 KHz to 80 MHz
3 Vrms,
150 KHz to 80 MHz
Conducted RF
IEC 61000-4-6
3 Vrms,
150 KHz to 80 MHz
3 Vrms,
150 KHz to 80 MHz
Portable and mobile RF
communications equipment
should be used no closer to
any part of the Gait Trainer 3,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the