mectron Piezosurgery - Page 46

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 Manualofuseandmaintenance
Guidance and manufacturer’s declaration - Electromagnetic immunity
ThePiezosurgeryMedicaldeviceisdesignedtoworkintheelectromagneticenvironmentspeciedbelow.
TheclientoruserofthePiezosurgeryMedicalshouldalwaysmakesurethatitisusedonlyinsuch
environment.
Immunitytest
IEC60601
Testlevel
Compliance
level
Electromagneticenvironment-Guidance
ConductedRF
IEC61000-4-6
RadiatedRF
IEC61000-4-3
3Veff
from150kHzto80MHz
3V/m
from80MHzto2,5GHz
3Veff
3V/m
PortableormobileRFcommunicationdevice
mustnotbeusedincloseproximityoftheproduct,
includingitscables,exceptwhentheserespect
thedistancesofseparationrecommendedand
calculatedfromtheequationapplicabletothe
frequencyofthetransmitter.
Recommended distances of separation
d = 1,2 √P
d = 1,2 √P from 80 MHz to 800 MHz
d = 2,3 √P from 800 MHz to 2,5 GHz
wherePisthemaximumnominaloutputpower
ofthetransmitterinWatts(W)accordingtothe
transmittermanufacturer,anddistheseparation
distancerecommendedinmeters(m).
TheeldintensityofthexedRF,asdetermined
byanelectromagneticinvestigationofthesite,
a

couldbelowerthanthelevelofconformityineach
frequencyinterval
b
.
Interferencemayoccurwheninproximitytodevice
markedwiththefollowingsymbol:
Note:
(1)at80MHzand800MHzthehighestfrequencyintervalisapplied.
(2)  These guidelines might not apply to all situations. Electromagnetic propagation is inuenced by the
absorptionandbythereectionofthestructure,objectsandpeople.
a    The eld intensity for xed transmitters such as radio-telephone stations (mobiles and cordless) and
land radio cars, amateur radio equipment,AM and FM radio transmitters, and TV transmitters, cannot
beidentiedtheoreticallyandprecisely.ToestablishanelectromagneticenvironmentcausedbyxedRF
transmitters,oneshouldconsideranelectromagneticinvestigationofthesite.Iftheeldintensitymeasured
intheenvironmentwherethePiezosurgeryMedicaldeviceisbeingused,exceedstheaboveapplicable
levelofconformity,oneshouldexaminethenormalfunctionofthePiezosurgeryMedicalDevice.Ifabnormal
performanceisobserved,itmaybenecessarytoapplyadditionalmeasuressuchasadifferentorientation
orpositioningofthePiezosurgeryMedicaldevice.
bTheeldintensityonafrequencyintervaloffrom150kHzto80MHzshouldbelessthan3V/m.