61000-3-3
purposes.
Electromagnetic Immunity: (IEC60601-1-2)
Immunity test
IEC60601-1-2 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 %.
Electric fast
transient/ burst IEC
61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Not applicable
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
Not applicable
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
inU
T
.） for 0.5 cycle
40 % U
T
（60% dip in
U
T
）for 5 cycles
70 % U
T
(30% dip
inU
T
) for 25 cycles
<5 % U
T
（95% dip
inU
T
）for 5 sec.
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
upper arm style requires continued
operation during power mains
interruptions, it is recommended
that Afib Talk be powered from an
uninterruptible power supply or a
battery.
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.
Immunity test
IEC60601-1-2
test level
IEC60601-1-2
test level
Electromagnetic environment - guidance
