Lansinoh AFFINITY User Manual - page 9
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
TheAffinityDoubleElectricBreastPumpisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbances
arecontrolled.ThecustomerortheuseroftheAffinityDoubleElectricBreastPumpcanhelppreventelectromagneticinterferenceby
maintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheAffinityDouble
ElectricBreastPumpasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.
ForTransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmetres(m)can
beestimatedusingtheequationapplicabletothefrequencyofthetransmitter.WherePisthemaximumoutputpowerratingofthe
transmitterinwatts(W)accordingtothetransmittermanufacturer.
NOTE1At80MHzand800Mhz,theseparationdistanceforthehigherfrequencyrangeapplies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfrom
structures,objectsandpeople.
Rated maximum output power
of transmitter
W
0,01
0,1
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
TheAffinityDoubleElectricBreastPumpisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerorthe
useroftheAffinityDoubleElectricBreastPumpshouldassurethatitisusedinsuchanenvironment.
Compliance
Group1
ClassB
ClassA
Complies
Emissions test
RFemissions
CISPR11
RFemissions
CISPR11
Harmonic emissions
IEC61000-3-2
Voltagefluctuations/
flickeremissions
IEC61000-3-3
Electromagnetic environment - guidance
TheAffinityDoubleElectricBreastPumpusesRFenergyonlyforitsinternal
function.Therefore,itsRFemissionsareverylowandarenotlikelytocauseany
interference in nearby electronic equipment.
TheAffinityDoubleElectricBreastPumpissuitableforuseinallestablishments,
includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclow-
voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.
Electromagnetic Immunity (all devices) - Table 202 according to EN 60601-1-2
Guidance and manufacturer’s declaration - electromagnetic immunity
TheAffinityDoubleElectricBreastPumpisintendedforusetheelectromagneticenvironmentspecifiedbelow.Thecustomerortheuser
oftheAffinityDoubleElectricBreastPumpshouldassurethatitisusedinsuchanenvironment.
IEC 60601 test level
±6kVcontact
±8kVair
±2kVforpowersupplylines
±1kVforinput/outputlines
±1kVline(s)toline(s)
±2kVline(s)toearth
<5%UT(0,5cycle)
40%UT(5cycles)
70%UT(25cycles)
<5%UTfor5s
3A/m
IMMUNITY test
Electrostatic
discharge(ESD)
IEC61000-4-2
Electricalfast
transient/burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltagedips,short
interruptions and voltage
variationsonpower
supply input lines
IEC61000-4-11
Powerfrequency
(50/60Hz)magnetic
fieldIEC61000-4-8
Compliance level
±6kVcontact
±8kVair
±2kVforpowersupplylines
±1kVforinput/outputlines
±1kVline(s)toline(s)
±2kVline(s)toearth
<5%UT(0,5cycle)
40%UT(5cycles)
70%UT(25cycles)
<5%UTfor5s
3A/m
Electromagnetic environment -
guidance
Floorsshouldbewood,concreteor
ceramictile.Iffloorsarecoveredwith
syntheticmaterial,therelativehumidity
should be at least 30%.
Mainspowerqualityshouldbethatofa
typical commercial or hospital environment.
Mainspowerqualityshouldbethatofa
typical commercial or hospital environment.
Mainspowerqualityshouldbethatofa
typical commercial or hospital environment.
Powerfrequencymagneticfieldsshould
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.