Medela Freestyle Hands-free Instrucciones De Uso página 38

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 Hands-free breast pump has no essential performance but was
tested for immunity to electromagnetic disturbances and passed using the following criteria:
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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.