V700 User Manual - Page 125

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Theirrecommendationtolimitwirelessdeviceusebychildrenwasstrictly

precautionary;itwasnotbasedonscientificevidencethatanyhealthhazard

exists.

11. What about wireless communications device interference with

medical equipment?

RadioFrequency(RF)energyfromwirelesscommunicationsdevicescan

interactwithsomeelectronicdevices.Forthisreason,theFDAhelped

developadetailedtestmethodtomeasureElectroMagneticInterference

(EMI)ofimplantedcardiacpacemakersanddefibrillatorsfromwireless

devices.Thistestmethodisnowpartofastandardsponsoredbythe

AssociationfortheAdvancementofMedicalInstrumentation(AAMI).The

finaldraft,ajointeffortbytheFDA,medicaldevicemanufacturers,and

manyothergroups,wascompletedinlate2000.Thisstandardwillallow

manufacturerstoensurethatcardiacpacemakersanddefibrillatorsaresafe

fromwirelesscommunicationsdeviceEMI.

TheFDAhastestedhearingaidsforinterferencefromhandheldwireless

devicesandhelpeddevelopavoluntarystandardsponsoredbytheInstitute

ofElectricalandElectronicEngineers(IEEE).Thisstandardspecifiestest

methodsandperformancerequirementsforhearingaidsandwireless

communicationsdevicessothatnointerferenceoccurswhenapersonuses

a“compatible”deviceanda“compatible”hearingaidatthesametime.This

standardwasapprovedbytheIEEEin2000.

TheFDAcontinuestomonitortheuseofwirelesscommunicationsdevices

forpossibleinteractionswithothermedicaldevices.Shouldharmful

interferencebefoundtooccur,theFDAwillconducttestingtoassessthe

interferenceandworktoresolvetheproblem.

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