bioMetric SpinalPak - Electromagnetic Compatibility

12 13
RFemissions
CISPR 11
Electromagnetic Compatibility
A. Theuseofaccessories,cablesorreplacementpartsotherthanthosesuppliedbyBiometmay
resultinincreasedemissionsordecreasedimmunityoftheequipmentorsystem.
B. Thisequipmentshouldnotbeusedadjacenttoorstackeduponotherequipment.
C. PortableandmobileRFcommunicationsequipmentcanadverselyaffecttheoperationof
MedicalElectricalEquipment.
D. Intheeventthisequipmentinterfereswiththeoperationofotherequipment,orexperiences
interferencefromotherequipment,tocontinuetreatment,itwillbenecessarytomovethe
Biomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemawayfromthesourceofthe
interferenceasindicatedinTable4.
Guidance and manufacturer’s declaration -
electromagnetic emissions
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.
Emissionstest Compliance Electromagneticenvironment-guidance
Group 1
TheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulator
SystemusesRFenergyonlyforitsinternalfunction.Therefore,
itsRFemissionsareverylowandnotlikelytocauseany
interferenceinnearbyelectronicequipment.
RFemissions
CISPR 11
Class B
TheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulator
System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.
Harmonic
emissions
IEC 61000-3-2
Notapplicable
Voltage
fluctuations/
flickeremissions
IEC 61000-3-3
Notapplicable
Table 1