bioMetric SpinalPak - Page 16

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Guidance and manufacturers declaration - electromagnetic immunity
TheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemisintendedforuseinthe
electromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemshouldassurethatitisusedinsuchanenvironment.
Immunitytest
IEC 60601
testlevel
Electromagneticenvironment-
guidance
Conducted RF
IEC 61000-4-6
NotApplicable
NOTE1. At80MHzand800MHz,thehigherfrequency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Biomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemisusedexceeds
the applicable RF compliance level, the Biomet
®
 SpinalPak
®
Non-invasive Spine Fusion Stimulator
Systemdeviceshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,
additional measures may be necessary, such as reorienting or relocating the Biomet
®
 SpinalPak
®
Non-invasiveSpineFusionStimulatorSystem.
 bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan1V/m.
Compliancelevel
NotApplicable
RadiatedRF
IEC 61000-4-3
3V/m
80MHzto2.5
GHz
1V/m
PortableandmobileRFcommunicationsequipment
shouldbeusednoclosertoanypartoftheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystem,
includingcables,thantherecommendedseparation
distancecalculatedfromtheequationapplicabletothe
frequencyofthetransmitter.
Recommendedseparationdistance
d=3.5√P80MHzto800MHz
d=7√P800MHzto2.5GHz
wherePisthemaximumpoweroutput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,ashouldbe
lessthanthecompliancelevelineachfrequencyrange.
b
Interferencemayoccurinthevicinityofequipment
markedwiththefollowingsymbol:
Table 3