BodyGuardian Heart Instructions for Use
32
Immunity
Immunity Test
IEC 60601-
1-2 Test
level
Compliance
level
Electromagnetic Environment
Electrostatic
discharge
(ESD)
IEC 61000-4-2
6 kV contact
8 kV air
IEC 60601-1-2
Test level
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
transient/burst
IEC 61000-4-4
2 kV for
power
supply lines
1 kV for
input/output
lines > 3 m
IEC 60601-1-2
Test level
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
IEC 60601-1-2
Test level
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
0% U
n
for 0.5
cycles
40 % U
n
for 5
cycles
70 % U
n
for
25 cycles
0 % U
n
for
5 s
IEC 60601-1-2
Test level
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the monitor requires
continued operation during
power mains interruptions,
it is recommended that the
monitor be powered from an
uninterruptible power supply
or battery.
Power
frequency
(50/60 Hz)
magnetic
field
IEC 61000-4-8
3 A/m
IEC 60601-1-2
Test level
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
