Declaration for Electromagnetic Compatibility (EMC)
For information use only
DEBP needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the instruction manual.
List of cables and assessories:
a. Tubing
b. Breastmilk Expression Set includes:
b1. ComfortFit Breast Flange (2)
b2. Breast Flange Body (2)
b3. Diaphragm (2)
b4. Diaphragm Cap (2)
b5. White Valve (2 + 2 extra)
b6. 5 oz (150ml) Bottles (2)
c. Breastmilk Storage Bottle Ring (2) and
Sealing Disk (2)
d. AC Adapter/Power Cord
e. Velcro Strap for Tubing
Do not use any other cables or accessories except what
is recommended by manufacturer. Change in cables or
accessories may negatively affect the performance of
the equipment.
FCC STATEMENT:
This device complies with part 15 of the FCC rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired operation.
Wireless statement:
Keep safe distance from portable and mobile RF
communications equipment as they can affect the
performance of DEBP.
Stacking:
DEBP should not be used adjacent to or stacked with
other equipment. And if adjacent or stacked use is
necessary, the DEBP should be observed to verify normal
operation in the configuration in which it will be used.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Double Electric Breast Pump model DEBP is intended for use in the electromagnetic environment specified below.
The customer or the user of the Double Electric Breast Pump should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
Class A
flicker emissions
IEC 61000-3-3
Electromagnetic environment – guidance
The DEBP uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any interfer-
ence in nearby electronic equipment.
The Model DEBP is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Not Applicable
Not Applicable
Recommended separation distance between
Portable and mobile RF communications equipment and the model @ 3Vrms
The model DEBP is intended for use in an electromagnetic environment in which radiated RF disturbances are con-
trolled. The customer or the user of the Model DEBP can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the Model DEBP
as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter m
Rated maximum
output power of
transmitter W
0.01 0.12
0.12
0.23
0.1 0.34
0.34
0.74
1 1.7
1.7
2.3
10 3.7
3.7
7.4
100 11.7
11.7
23.3
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in me-
ters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum
output rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for 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.
d
=
[
]
√
P
3.5
E
1
d
=
[
]
√
P
7
E
1
d
=
[
]
√
P
3.5
v
1
Guidance and manufacturer’s declaration – electromagnetic immunity
The Model DEBP is intended for use in the electromagnetic environment specified below.
The customer or the end user of the Model should assure that it is used in such an environment.
Immunity test
Electromagnetic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/ burst IEC
61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short interruptions
and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
IEC 60601 test level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
<5 % U
T
(>95 % dip in U
T
)
for 0.5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
3 A/m
Compliance level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
<5 % U
T
(>95 % dip in U
T
)
for 0.5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
3 A/m
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 Model DEBP requires continued
operation during power mains interruptions, it is
recommended that the Model DEBP be powered
from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Model DEBP is intended for use in the electromagnetic environment specified below.
The customer or the user of the Model DEBP should assure that it is used in such an environment.
Immunity test
Radiated RF
IEC 61000-4-3
Conducted RF
IEC 61000-4-6
IEC 60601 test level
3 V/m
80 MHz to 2.5 GHz
150 kHz to 80 MHz
Compliance level
3 V/m
3 VRMS
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the Model DEBP including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
d = 1.7
√
P 80 MHz to 800 MHz
d = 2.3
√
P 800 MHz to 2.5 GHz
d = [3.5/V1]
√
P
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.
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 Model DEBP is used exceeds the
applicable RF compliance level above, the Model DEBP should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the Model DEBP.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
