Users Manual

33

• Increasetheseparationbetweentheequipmentandreceiver.

• Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiveris

connected.

• Consultthedealeroranexperiencedradio/TVtechnicianforhelp.

Anychangesormodificationsnotexpresslyapprovedbythemanufacturercouldvoid

theuser’s

authoritytooperatetheequipment.ModificationsnotexpresslyapprovedbyDeviceManufacturer

couldvoidtheuser’sauthoritytooperatetheequipmentunderFCCrules.

FCCRFRadiationExposureStatement:

• ThisTransmittermustnotbeco‐locatedoroperatinginconjunctionwithanyotherantennaor

transmitter.

• ThisequipmentcomplieswithFCCRFradiationexposurelimitssetforthforanuncontrolled

environment.Thisdevicewastestedfortypicalhand‐heldop erationswiththedevicecontacted

directlytothehuman

bodytothesidesofthede‐vice.TomaintaincompliancewithFCCRF

exposurecompliancerequirements, avoid directcontacttothe transmittingantennaduring

transmitting.

ThisequipmentcomplieswithFCC/IC/EURFradiationexposurelimitssetforthforanuncontrolled

environment.ThehighestSARvaluefortheMD‐100deviceis<0.88W/kg.

InordertomaintaincomplianceasaClass1Medicaldevice,theswitchesthatareusedincombination

withtheMD‐100devicemustfulfilltheisolationrequirementsofIEC/EN60601‐1basedon15VDC.

Theymustbeelectricallyfloatingswitches(switchesthatarenotgrounded).

B2CEStatement

Thisequipmentcomplieswiththerequirementsrelatingtoelectromagneticcompatibility,theessential

protectionrequirementofElectromagneticCompatibility(EMC)Directive2014/30/EUonthe

approximationofthelawsoftheMemberStatesrelatingtoelectromagneticcompatibilityandRadio

EquipmentDirective(RED)2014/53/EUtomeettheregulationoftheradioequipmentand

telecommunicationsterminal

equipment.

B3DirectivesandStandards

TheMD‐100complieswiththefollowingdirectives:

• MedicalDeviceRegulation(MDR)

• LowvoltageDirective2014/35/EU

• ElectromagneticCompatibility(EMC)Directive2014/30/EU

• RadioEquipmentDirective(RED)2014/53/EU

• RoHS2Directive2011/65/EU

• WEEEDirective2012/19/EU

• ReachDirective2006/121/EC,1907/2006/ECAnnex17