21
iTENS - EMC Information continued
Guidance and manufacture’s declaration – electromagnetic immunity
The iTENS is intended for use in the electromagnetic environment
specified below. The customer or the user of iTENS 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
floor are covered
with synthetic
material, the
relative humidity
should be at
least 30%.
Electrical fast
transient/
burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2kV for power
supply lines
Mains power
quality should be
that of a typical
commercial
or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
±1 kV differential
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 610004-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power
quality should be
that of a typical
commercial
or hospital
environment. If
the user of the
iTENS requires
continued
operation during
power mains
interruptions, it
is recommended
that the iTENS
be powered
from an
uninterruptible
power supply or
a battery.
Power
frequency
(50Hz/60Hz)
magnetic
field IEC
61000-4-8
3 A/m 3 A/m Power frequency
magnetic
fields should
be at levels
characteristic of
a typical location
in a typical
commercial
or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.