ELVIE stride Instrucciones De Uso página 17

Guidance and manufacturer's declaration –
electromagnetic immunity
The Elvie Stride breast pump product is suitable for use in a specific
electromagnetic environment outlined below. The user of this product
should assure that it is used in such an environment. The Elvie Stride
breast pump was tested for immunity to electromagnetic disturbances
and passed using the following criteria:
1) No noticeable change in the operation of the breast
pump signifying maximum vacuum pressure is exceeded
or cycle speeds are degraded.
2) During charging, the pump did not turn on and start operating.
Immunity test IEC 60601 test level Compliance level
Electrostatic +/- 2kV, +/-
discharge 4kV, +/- 6kV,
(ESD) IEC +/- 8kV contact
61000-4-2 discharge
+/- 2kV, +/- 4kV,
+/- 6kV, +/- 8kV,
+/- 15 kV air
discharge
Power 30 A/m, 50
frequency or 60 Hz
(50/60 Hz)
magnetic
field IEC
61000-4-8
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Electromagnetic
environment guidance
+/- 2kV, +/- Floors should be
4kV, +/- 6kV, wood, concrete
+/- 8kV contact or ceramic tile.
discharge If floors are
covered with
+/- 2kV, +/- 4kV, synthetic
+/- 6kV, +/- 8kV, material, the
+/- 15 kV relative
air discharge humidity should
be at least 30%.
30 A/m, 50 It may be
or 60 Hz 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.
Guidance and manufacturer's declaration –
electromagnetic immunity
Immunity test IEC 60601 test level
Radiated 10 V/m
RF (minimum)
IEC 80 MHz –
61000-4-3 2,7 GHz
80 % AM
at 1 kHz
Electromagnetic environment guidance: 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 metres (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic site survey, a 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
A. 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.
B. Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 10 V/m.
Compliance level
10V/m
(minimum)
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