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Recommended separation distances between portable and mobile RF Communications Equipment and the Affinity Double 
Electric Breast Pump - Table 206 according to EN 60601-1-2

Recommended separation distances

Recommended separation distances between portable and mobile RF communications and the Affinity Double Electric Breast Pump

The Affinity Double Electric Breast Pump is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Affinity Double Electric Breast Pump can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Affinity Double
Electric Breast Pump as recommended below, according to the maximum output power of the communications equipment.

For Transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can 
be estimated using the equation applicable to the frequency of the transmitter. Where P is the maximum output power 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.

Rated maximum output power
of transmitter 
W

0,01 

0,1 

10 

100

800 MHZ to 2,5 GHz

P

d =

7

E

1

7cm

22cm

70cm

2,2m

7m

Separation distance according to frequency of transmitter m

3,5cm

11cm

35cm

1,1m

3,5m

80 MHZ to 800 MHz

P

d =

3,5

E

1

11,7cm

36,9cm

1,2m

3,7m

11,7m

150 kHZ to 80 MHz

P

d =

3,5

V

1

15

16

Declarations for Electromagnetic Compatibility (EMC)

Electromagnetic Emissions - Table 201 according to EN 60601-1-2

Guidance and manufacturer’s declaration - electromagnetic emissions

The Affinity Double Electric Breast Pump is intended for use in the electromagnetic environment specified below. The customer or the 
user of the Affinity Double Electric Breast Pump should assure that it is used in such an environment.

Compliance 

Group 1

Class B

Class A

Complies

Emissions test

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Electromagnetic environment - guidance 

The Affinity Double Electric Breast Pump uses RF energy only for its internal 
function. Therefore, its RF emissions are very low and are not likely to cause any 

interference in nearby electronic equipment.

The Affinity Double Electric Breast Pump 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.

Electromagnetic Immunity (all devices) - Table 202 according to EN 60601-1-2

Guidance and manufacturer’s declaration - electromagnetic immunity

The Affinity Double Electric Breast Pump is intended for use the electromagnetic environment specified below. The customer or the user 
of the Affinity Double Electric Breast Pump should assure that it is used in such an environment.

IEC 60601 test level

± 6 kV contact
± 8 kV air

± 2 kV for power supply lines
± 1kV for input/output lines

± 1 kV line(s) to line(s)
± 2kV line(s) to earth

<5 % UT (0,5 cycle)
40 % UT (5 cycles)
70 % UT (25 cycles)
<5 % UT for 5s

3 A/m

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 

interruptions and voltage 

variations on power 

supply input lines

IEC 61000-4-11

Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8

Compliance level 

± 6 kV contact
± 8 kV air

± 2 kV for power supply lines
± 1kV for input/output lines

± 1 kV line(s) to line(s)
± 2kV line(s) to earth

<5 % UT (0,5 cycle)
40 % UT (5 cycles)
70 % UT (25 cycles)
<5 % UT for 5s

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. 

Power frequency magnetic fields should 

 

be at levels characteristic of a typical 
locations in a typical commercial or  
hospital environment.

NOTE: U

T

 is the a.c mains voltage prior to application of the test level.

Summary of Contents for AFFINITY

Page 1: ...Bisphenol A FREE Double Electric Breast Pump Custom Expression Technology ComfortFit Breast Cushions Independently Adjustable Cycle and Suction Levels Easy to Use Easy to Clean...

Page 2: ...uipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help When using electrical products especiall...

Page 3: ...2 3 4 5 Cycle indicator Time level indicator Low battery indicator Let down Stimulation Phase indicator Expression Phase indicator Suction indicator Tubing Adapter Input 6 7 8 9 10 11 Bottle holder 2...

Page 4: ...To First Use 1 Prior to using the set for the first time disassemble and boil all parts of the Breastmilk Expression Set for 10 minutes Note Ensure you use enough water to keep parts afloat while boi...

Page 5: ...o be helpful Some mums can achieve more than one let down during a pumping session You may be able to achieve a second or third let down during your pumping session by pressing the Quick Change button...

Page 6: ...on to increase the cycle length which creates a slower pumping rhythm for more powerful milk expression Note The highest cycle setting L6 actually creates the slowest pumping rhythm while the lowest c...

Page 7: ...der cool running water gradually warming the water until the milk is thawed Thawed milk can be kept in a refrigerator for up to 24 hours NOTE DO NOT refreeze milk once it is thawed Gently shake thawed...

Page 8: ...rruption of Electrical Service If you experience an interruption in the normal operation of the electrical and or mechanical functioning of the pump simply do the following Unplug the AC adapter cord...

Page 9: ...ass A Complies Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Electromagnetic environment guidance The...

Page 10: ...7 Protection Class II ISO 13485 ISO 9001 CE 1007 EN 980 EN1041 EN14350 for part numbers 50414 50406 50413 Operation Transport Storage 5 C 40 C 20 C 50 C Operation Transport Storage Electromagnetic Com...

Page 11: ...se II you may adjust cycle level by pressing or next to cycle icon The highest cycle setting L6 actually creates the slowest pumping rhythm while the lowest cycle setting L1 creates the fastest pumpin...

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