21
Guidance and Manufacturer’s Declaratlon - 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 used in such an environment
THE LANSINOH® SIGNATURE PRO®
ELECTRIC 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.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetlc Environment - Guidance
Electrostatic discharge
(ESD)
IEC 61000 -4-2
± 8 kV contact ± 2
kV, ± 4kV, ± 8 kV, ±
15kV air
± 8 kV contact
± 2 kV, ± 4kV, ± 8 kV ±
15kV air
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.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
0% UT; 0.5 cycle At
0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% UT; 0.5 cycle At
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
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.
Power frequency
(50/60 Hz) magnetic field
IEC 61000 -4-8
30A/m
30 A/m
It may be necessary to position the breast pump further from sources
of power frequency magnetic fields or to install magnetic shielding.
The power frequency magnetic field should be measured in the
intended installation location to assure that it is sufficiently low.
Conducted RF
IEC 61000 -4-6
Radiated RF
IEC 61000-4-3
3V 0,15 MHz - 80
MHz 6 Vin ISM and
amateur radio bands
between 0,15 MHz
and 80MHz 80 % AM
at 1 KHz
lOV/m 80 MHz -2,7
GHz 80% AM at
1 KHz
6V
lOV/m
Portable and mobile RF communications equipment should be used
no closer to any part of the breast pump, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommend separation distance
d = 1.2
√
P
d= 1.2
√
P 80 MHz -800 MHz
d= 2.3
√
P 800 MHz- 2.7 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters ,as determined by an
electromagnetic site survey, should be less than the compliance level
in each frequency range. Interference may occur in the vicinity of
equipment marked with the following symbol.
Note 1
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the Electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the breast pump is used
exceeds the applicable RF compliance level above, the breast pump should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the breast pump. Over the frequency range 150 KHz to 80 MHz, field strengths
should be less than 10 V/m.
