Medela Pump In Style Pro+ Mode D'emploi page 12

Guidance and manufacturer's declaration – electromagnetic immunity
12
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 Pump In Style Pro+ breast pump has no essential
®
performance but was tested for immunity to electromagnetic
disturbances and passed using the following criteria:
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/
burst IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interrup-
tions and voltage variations
on power supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
IEC 60601 test level Compliance level
+/- 8kV +/- 8kV
contact discharge contact discharge
+/- 2kV, +/- 4kV, +/- 2kV, +/- 4kV,
+/- 8kV, +/- 15 kV +/- 8kV, +/- 15 kV
air discharge air discharge
± 2 kV ± 2 kV
5 kHz repetition 5 kHz repetition
frequency frequency
± 0,5 kV, ± 1 kV ± 0,5 kV, ± 1 kV
Line-to-line Line-to-line
0 % UT; 0,5 cycle 0 % UT; 0,5 cycle
At 0°, 45°, 90°, At 0°, 45°, 90°,
135°, 180°, 225°, 135°, 180°, 225°,
270°, and 315° 270°, and 315°
0% UT; 1 cycle 0% UT; 1 cycle
70% UT; 30 cycles 70% UT; 30 cycles
0% UT; 300 cycles 0% UT; 300 cycles
30 A/m, 50 or 60 Hz 30 A/m, 50/60 Hz
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.
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 30%.
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.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
breast pump requires continued operation during power
mains interruptions, it is recommended that the breast
pump be powered from an uninterruptible power supply
or a battery.
It may be necessary to position the breast pump further
from sources of power frequency magnetic fields or to in-
stall magnetic shielding. The power frequency magnetic
field should be measured in the intended installation
location to assure that it is sufficiently low.