TOP-X100NR USER MANUAL
Innomed Medical Inc.
43
Guidance and manufacturer’s declaration – electromagnetic immunity
TOP-X generator is intended for use in electromagnetic environment specified below.
The customer or the user of TOP-X generator 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
transients/
bursts
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 differential
mode
±
2 kV common
mode
±
1 kV differential
mode
±
2 kV common
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% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycle
70% U
T
(30% dip in U
T
)
for 25 cycle
< 5% U
T
(>95% dip in U
T
)
for 5 sec
< 5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycle
70% U
T
(30% dip in U
T
)
for 25 cycle
< 5% U
T
(>95% dip in U
T
)
for 5 sec
Mains power quality should
be
that
of
a
typical
commercial
or
hospital
environment.
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
characteristics of a typical
location
in
a
typical
commercial
or
hospital
environment.
Note: U
T
is the AC mains voltage prior to application of the test level
