10
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
– This battery pack
is intended for use in the electromagnetic environment specified below. The user of this
battery pack should make sure 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
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, con-
crete 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
(Note 2)
±2 kV for power
supply lines
±1 kV for input-out-
put lines
±2 kV for supply
mains
±1 kV for input/out-
put lines
Mains power quality should
be that of a typical home or
hospital environment.
Surge
IEC 61000-4-5
(Note 2)
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV for common
mode
Mains power quality should
be that of a typical home or
hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
(Note 2)
<5% U
T
(>95% dip in
U
T
) for
0.5 cycle at 45 degree
increments
70% U
T
(30% dip in
U
T
) for
0.5 seconds
<5% U
T
(>95% dip in
U
T
) for
5 seconds
<5% UT (>95% dip in
U
T
) for
0.5 cycle at 45 degree
increments
70% U
T
(30% dip in
U
T
) for
0.5 seconds
<5% U
T
(>95% dip in
U
T
) for
5 seconds
Mains power quality should
be that of a typical home or
hospital environment. If the
user of the device requires
continued operation during
power mains interruptions,
it is recommended that the
device be powered from an
uninterruptible power supply
or a battery.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic
fields should be at levels char-
acteristic of a typical location
in a typical hospital or home
environment.
Notes:
(1) U
T
is the ac mains voltage prior to application of the test level.
(2) The battery pack uses the therapy device supplied ac/dc adapter for charging and does not connect directly
to the ac mains. The presence of the battery pack in the connection does not affect overall compliance status.
