Kinesis Savant Elite2 - Page 4

AGENCY&REGULATORYAPPROVALS
Overview
 FCC/CEClassBforITandmedicalapplica‐
ons
 ULrecognizedcomponentfornearpaent
useinUS&Canada,ETLcontrolnumber
4007055.ConformstoUL60601‐1,Cer‐
fiedtoCSASTDC22.2NO.601.1
 RoHSCompliant(lead‐free)
FEDERALCOMMUNICATIONSCOMMISSION
RADIOFREQUENCYINTERFERENCESTATEMENT
Thisequipmenthasbeentestedandfoundto
complywiththelimitsforaClassBdigitaldevice,
pursuanttoPart15oftheFCCRules.These
limitsaredesignedtoprovidereasonablepro‐
teconagainstharmfulinterferencewhenthe
equipmentis
operatedinaresidenal installa‐
on.

Thisequipmentgenerates,usesandcanradiate
radiofrequencyenergyand,ifnotinstalledand
usedinaccordancewiththeinstrucons,may
causeharmfulinterferencetoradiocommunica‐
ons.However,thereisnoguaranteethatinter‐
ferencewillnotoccurin
aparcularinstallaon.

Ifthisequipmentdoescauseharmfulinterfer‐
encetoradioortelevisionrecepon,whichcan
bedeterminedbyturningtheequipmentoffand
on,theuserisencouragedtotrytocorrectthe
interferencebyoneormoreofthefollowing
measures:

 Reorientorrelocatethereceivingantenna
 Increasetheseparaon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ra‐
dio/TVtechnicianforhelp
Warning
Toassureconnu edFCCcompliance,theuser
mustuseonlyshieldedinterfacingcableswhen
connecngtocomputerorperipheral.Also,any
unauthorizedchangesormodificaonstothis
equipmentwouldvoidtheuser’sauthorityto
operate.
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INDUSTRYCANADACOMPLIANCESTATEMENT
ThisClassBdigitalapparatusmeetsall
requirementsoftheCanadianInterface‐
causingEquipmentRegulaons.CetAp‐
pareilnumériquedelaclasseBrespecte
touteslesexigencesduRèglementsurle
matérialbroilleurduCanada.

CECOMPLIANCEFOREMISSIONSANDIMMUNI-
TY
Thisdevicehasbeentestedtocomplywiththe
followingEuropeanstandardsforemissionsand
immunityforITEandmedicalequipment:
En55022,En 55024,EN61000‐3‐2/3,and
EN60601‐1‐2.

MEDICALPRODUCTSAFETY
SavantElite2productsarerecognizedcompo‐
nents,conformingtoULstandard60601‐1;Cer‐
fiedtoCSAstandardC22.2NO.601.1.TheETL
lisngnumberis4007055.

TheETLRecognizedComponentmarkonthe
productlabelindicatescompliancewithUL
60601‐1andCSAStdC22.2No.601.1standards
formedicaluse.Theseproductsmust
beused
withaUL‐listedcomputerorUL‐listedcomputer‐
izedequipmenttocomplywithULsafetystand‐
ards.ThelabelwillalsoindicateeitherIPX1per
ULandCEstandardsfor“drip‐proof”water
resistance,orIPX8forwaterproofmodels.

ThisUSBinputdevicewasnotde signed as
afault
‐tolerantmedicaldevice.Inamedicalseng,it
isintendedforuseasacomponentofaUL‐listed
diagnoscinstrument,notforpaentcare.
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Thisproductshouldnotbeusedinthepresence
ofaflammableatmospheresuchasananes‐
thec
mixturewithair,oxygen,ornitrousoxide.
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