Medela Freestyle Flex Mode D'emploi page 51

Guidance and manufacturer's declaration – electromagnetic immunity
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 Freestyle Flex breast
pump has no essential performance but was tested for immunity to electromagnetic disturbances and
passed using the following criteria:
1. No change in mode and operation of the breast pump.
2. The pump can be controlled by changing the vacuum level and/or pressing the On/Off button.
3. The Bluetooth communication may be impaired temporarily but may never be completely interrupted in
such a way that a new pairing is necessary.
Reset: (The following sequence can be used to reset the device in the event of an EM Disturbance)
1. Unplug the power cable from the motor unit.
2. Unplug the power adaptor from the wall outlet.
3. Attach a breast pump set to the tubing port (if none is attached).
4. Press and hold the On/Off button for seven to ten seconds.
5. Plug the power adaptor back into the wall outlet.
6. Plug the power cable into the supply socket of the motor unit.
7. Press the On/Off button to switch the breast pump on.
8. Press the Start/Pause button to begin pumping.
Immunity test
Electrostatic
discharge ( ESD )
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
IEC 60601
test level
+/- 8 kV
contact discharge
+/- 15 kV
air discharge
± 2 kV
for power supply lines
± 0,5 kV, ± 1 kV
Line-to-line
Compliance level
+/- 8 kV
contact discharge
+/- 15 kV
air discharge
± 2 kV
for power supply lines
± 0,5 kV, ± 1 kV
Line-to-line
Electromagnetic
environment
– guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 5%.
Mains power quality
should be that of a typical
commercial or hospital
environment.
Mains power quality
should be that of a typical
commercial or hospital
environment.
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