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Questions? Visit www.medela.com or call us at 1-800-435-8316.
49
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment
– guidance
Electrostatic
discharge ( ESD )
IEC 61000-4-2
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV
contact discharge
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV,
+/- 15 kV air discharge
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV
contact discharge
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV,
+/- 15 kV air discharge
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
100 kHz repetition
frequency
± 2 kV
100 kHz repetition
frequency
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
± 0,5 kV, ± 1 kV
Line-to-line
± 0,5 kV, ± 1 kV
Line-to-line
Mains power quality
should be that of a typical
commercial or hospital
environment.
This breast pump is intended for use in the electromagnetic environment specified below. The customer or
the user of the breast pump should assure that it is used in such an environment. The Sonata Breast Pump
has no essential performance but was tested for immunity to electromagnetic disturbances and passed
using the following criteria:
1. No visible change in the operation of the breast pump.
2. The breast pump changes settings but returns automatically to previous settings.
3. The breast pump changes settings but can return to previous settings by intervention of the user.
4. The breast pump changes settings but can return to previous settings by executing the
INITIATION SEQUENCE.
INITIATION SEQUENCE: (The following sequence can be used to reset the device in the event of an
EM Disturbance)
1. Unplug the power cord from the back of the breast pump.
2. Unplug the power adaptor from the wall outlet.
3. Attach a breast pump kit to the pump port (if none is attached).
4. Press and hold the power button for at least 30 seconds. (Note: The breast pump may cycle
on/off several times. After 30 seconds the breast pump should remain off.)
5. Plug the power adaptor back into the wall outlet.
6. Plug the power cord into the back of the breast pump.
7. Press the on/off switch to power on the breast pump.
8. Press the ‘PLAY’ button to begin pumping.
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