Expain 002 User manual

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BACKUPRELIEFBELTUSERMANUAL Ver.1.0

UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway
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ProductName:BACKUPBELT
ModelNumber:002
Companyname:EXPAINAS
Address:KarlJohansgate130154OsloNorway
ContactName:ThomasJakobsen
Telephonenumber:+4797035997
Faxnumber:+4792040756
Email:[e-mail]


BACKUPRELIEFBELTUSERMANUAL Ver.1.0

UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway
Contain
1.Parts&Controls............................................................................................................................1
PARTS.........................................................................................................................................1
CONTROLS.................................................................................................................................1
2.Introduction..................................................................................................................................1
3Beforeuse......................................................................................................................................2
4Supportfunctionality.....................................................................................................................2
5TENSfunctionality..........................................................................................................................3
APPLYINGTHEGELPADSTOTHEMAINUNIT...........................................................................3
HOWDOESITWORK.................................................................................................................4
TREATMENTRECOMMENDATIONS...........................................................................................4
CONDUCTINGATENSTREATMENT...........................................................................................4
6HEATfunctionality..........................................................................................................................5
CONDUCTINGAHEATTREATMENT...........................................................................................5
7RemovingtheBackupBelt.............................................................................................................5
8Batteries&charging.......................................................................................................................6
9Maintenanceandstorage..............................................................................................................6
10TechnicalSpecifications................................................................................................................7
11Safetyinformation........................................................................................................................7
12.ManufacturersDeclarction.........................................................................................................9
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
BACKUPRELIEFBELTUSERMANUAL Ver.1.0

UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway1
1.Parts&Controls
PARTS
1. Belt
a. Innerbelts(right&left)
b. Beltbackplate
c. Magneticconnectors
d. Tensioningbelts(right&left)
2. Remote
3. Mainunit
a. ElectrodeArea:Surfacewherethegelpadsareplacedb.Electronicshousing
4. USBcable&Charger
5. Gelpads
6. Manual

CONTROLS
7. MainunitOn/Off
8. MainunitIndicatorLight
9. RemoteunitOn/Off
10. TENSOn/“+”button
11. TENSOff/“‐“button
12. HEATOn/Offbutton
13. TENSsignallight
14. HEATsignallight
2.Introduction
CongratulationsonyourpurchaseoftheBackupBelt.Itisauniquewirelessremotecontrolled
painreliefdeviceincorporatingactiveheating,structuralsupportandTENStechnologyto

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway2
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specificallytargetbackpain.
Thisinnovativedeviceissafe,drug‐free,easytouse,discreetandcomfortabletowear,andmost
importantlyallowsyoutocontrolyourpaintomaintainanactivelifestyle.
3Beforeuse
YourBackupBelthasbeendesignedwiththehomeuserinmind.Pleaseconsultthesafety
precautionsandcontraindicationsinthismanualpriortouse.
Beforeusingthemainunitthefirsttimepleasechargethemainunit.Inserttheusbcableto
thecharger.Plugthechargerintothemainsmakingsurebeforethatthechargeriscompatible
tothemainsinyourcurrentlocation.Thenconnectthemainunit.Themainunitindicator
lightwillflashgreenevery5thsecondduringcharging.Theunitisfullychargedafter2hrs
(2000mAh).
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4Supportfunctionality
ThesupportfunctionofyourBackupBeltiscompletelyanalogandreadytouse.Putonthebelt
likethis:
1. 1.Makesurethebeltisfacingtherightway.Themagneticconnectorsshouldfacetowards
yourbodyanddown
2. Thebeltlengthcanbeadjustedbymovingtheinnerright&leftbeltalongthebeltbackplate,
fasteningbymeansofthevelcro.
3. Toinsertthemainunitinsertthenotchinthetopofthemainunitintothematchingtabon
thebeltbackplate.Thenpressmainunitthroughtheopeningallowingthemagnetic
connectorsonthemainunit&beltbackplatetoconnect.

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway3
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4. Holdthebackplatewithmainunittowardsyourlowerback.Ifusingthegelpadsseenext
pagefordetailedinstructions.Grabtheinnerfasteningbeltandwrapitaroundyourbody.
TightencomfortablyandfastenwiththeVelcro.Righthandsidegoesoverthelefthandside.
5. Totightenthesupportingbeltgrabbothoutertensioningbeltsandpullthemuntilyoufeel
youhavedesiredsupport.FastenwiththeVelcro.Righthandsidegoesoverthelefthandside
heretoo.
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5TENSfunctionality
BeforeusingtheTENSfunctionalityofyourBackupBeltyouwillneedtoapplythegelpadstothe
mainunit,Insertthemainunitinthebeltandpreparethedeviceforatreatment.
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APPLYING THE GEL PADS TO THE MAIN UNIT
Thegelpadsareintendedforsinglepersonuse.Theywilllast,dependingonskintype,oils,and
pHlevels,approximatelytwotofiveapplications.Replacethegelpadswhentheynolonger
adherecompletely.Followthesestepstoapplythegelpads:

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway4
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1. Trim,notshave,excessivehaironthetreatmentarea.
2. Washtheskinanddrycompletely
3. Separatethetwogelpads.
4. Removethefilmwithprintreading“ELECTRODE”fromthesidebeingappliedtotheelectrode
area.Thisfilmisthesmallestofthetwo.Donotremovetheprotectivelineronthe“skinside”
yet.
5. Aligntheshapeofthefirstgelpadwiththeelectrodearea.Applythegelpadontothe
electrodeareaandfirmlypressacrosstheentiresurfacetoensuregoodadhesion.
6. Repeatsteps3–5forthesecondgelpad.
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HOW DOES IT WORK
Tenstreatmentworksintwoways.Itstimulatesnervesthatnormallycarriespainsignalsthus
“blocking”these(“closingthepaingate”).Italsoreleasesendorphinsasiffromexercise,
endorphinsisthebody`s“naturalpainkillers”.
TREATMENT RECOMMENDATIONS
•Youcanleavethedeviceinpositionformultipletreatmentsduringtheday.Itwill
automaticallyturnOffafterone(1)houroftreatment.Ifnotreatmentisactivetheunitwillturn
offcompletelyafter15minutes.
•Itisrecommendedyouwaitaminimumof30minutesbetweentreatments.
CONDUCTINGA TENS TREATMENT
Alwaysreadthesafetywarningsbeforeconductingatreatment.Followthesestepstoconducta
treatment:
1. Removetheprotectivelinersfromthe“skinside”ofthegelpadsbyslowlypeelingtheliner
diagonallyfromaninsidecornertotheoppositeoutsidecorner.Important!Avoidcontactof
thegelpadwithotherobjects.Contactwithotherobjectsmayaffectthepadsadhesion
properties.Savethelinersforstorageofthedevice.
2. Alignthecenterofthedeviceoverthespineandplacethedeviceonyourbackintheareaof
pain.Ifyoucannotplacethedeviceproperly,askanotherpersonforassistance.Important!Do
notapplythegelpads/electrodesdirectlyoverthespine.
3. PresstheOn/Offbuttononthemainunit.TheLEDwillflashgreenfor10secondsindicating
thedeviceisreadyforuse.
4. PresstheON/OFFbuttonontheremote.Bothsignallightswillblinktwicetosignalremoteis
on.Thenpressthe“+”buttonontheremotecontroltobeginthetreatment.TheTENSsignal
lightontheremotewillblinkoncetoindicatesignalissentfromremote.Note:TheLEDonthe
mainunitwillflashbluefor10secondstoindicateTENStreatmentisactivated.
5. Pressthe(+/‐)buttonstoincreaseordecreasetheintensityofthestimulationuntilitisata
comfortablelevel.Thereare4levels.
6. PresstheON/OFFbuttonontheremotecontroltostopthetreatmentatanytime.Both
indicatorlightswillblinktwicetosignalremoteisoff.Treatmentwillautomaticallystopafter1
hourofinactivity(notpressinganybuttons)‐Alternativelypressthe“‐“buttonseveraltimes
toreduceintensityandfinallyturnoffthetreatment.

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway5

Note:Ifatreatmentisstoppedandrestartedthetreatmentwillrestartatthefirststage,and
willrunforanewfullhour.Note:Turningtheremoteoffwillalsoturnthemainunitoff!To
resumetreatmentbothmainunit&remotemustbeturnedbackonseperately.
6HEATfunctionality
CONDUCTING A HEAT TREATMENT
1.PresstheHEATbuttonontheremote.Theheatsignallightontheremotewillblinkonceto
showthatasignalissenttothemainunit.
2.Thebeltwillstarttheheatingandlastfor20minutesbeforeautomaticallyturningoff.The
mainunitindicatorlightwillblinkyellowfor10secondstoindicateaheattreatmenthas
started.Theheatingtemperatureis42°C.Itwilltakeabitoftimebeforeyoucanfeelthe
heatafteractivation.Theunitwillhaveenoughbatteryfor8fullHEATtreatmentsperfull
charge.
3.TostoptheHEATtreatmentbeforethe20minuteshavepassedsimplypresstheHEAT
buttonontheremoteonemoretime.AlternativelypressandholdtheremoteON/OFF
buttontoturnoffbothremoteandmainunitinstantly.


7RemovingtheBackupBelt
1. Aftertreatment,orwhenyouwanttoremovethedevice,loosenthesupportbelt,graspthe
edgeofthedeviceandgelpadtoensurethegelpaddoesnotstayontheskin.Slowlypeelthe
deviceawayfromtheskin.
2. Align,andplacetheprotectivelinersbackonthegelpads.Ensurethepadsarecompletely
covered.Important!Donotremovethedeviceuntiltenstreatmenthasstopped.

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway6


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8Batteries&charging
Whenmainunitrechargeisneededthemainunitindicaterwillflashred:RechargewithUSB
charger.
Whentheremotecontrolislowonbatterynoindicationswilllightupifbuttonsarepressed.
ToREPPLACETHEREMOTECONTROLBATTERY:
1.Gentlysnapoffthefrontcoverwherethe“+”&“—“buttonsare,youwillthensee2screws.
2.UnscrewthesewithincludedscrewdrivertoaccessthecatteryonthebackofthePCB.
3.Slidetheoldbatteryout,andslideanew(1)CR2016Elithiumbatteryintotheslot.Note:The(+)
isfacingupward

Reversetheprocesstoclosetheremote.


9Maintenanceandstorage
•Cleanthedeviceusingadampclothandmildsoap.Gentlywipeclean.
•Theright&leftinnerbeltscanbewashedat30degrees.DoNOTwashthebeltbackplateasit
containselectronicsfortheheatingfunctionality.
•Donotsubmergetheproductinliquid.
•Thedeviceshouldbeoperated,transportedandstoredattemperaturesbetween10°Cand40°
C,withrelativehumiditybetween30%‐85%,andAtmosphericPressurelimitationof500hPato
1060hPa.
Allvalueshave+/‐10%tolerance.
•Storethedevice,remotecontrolandgelpadsintheoriginalpackagingwhennotinuse.
•Ifthedeviceisnotworkingproperly,stopusingimmediately.Donotdisassembleormodifythe
device.ContactUnikiaCustomerServiceat[email protected]

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway7

10TechnicalSpecifications
WARRANTY
COMPANYSHALLNOTBELIABLEINANYEVENTFORINCIDENTALORCONSEQUENTIALDAMAGES.
Unikia(“Company”)warrantstheBackupBelt(“Product”)isfreeofdefectsinmaterialsand
workmanship.Thiswarrantyshallremainineffectasperthelegislationofthecountryinwhich
theunitwaspurchased.
11Safetyinformation
INDICATIONSFORUSE
Fortemporaryreliefofpainassociatedwithsoreandachingmusclesinthelowerbackdueto
strainfromexerciseornormalhouseholdandworkactivities.
SAFETYCONTRAINDICATIONSDonotusetheTENStreatmentonthisdeviceifyouhaveacardiac
pacemaker,implanteddefibrillator,orotherimplantedmetallicorelectronicdevice.Suchuse
couldcauseelectricshock,burns,orelectricalinterferenceordeath.


Technicalspecifications
Channels:Singlechannel
Waveform:Asymmetricbiphasicsquarepulse
PulseAmplitude:0~110mA=0~55volts,adjustable(at500ohmload)
PulseFrequency:(Hz)5‐120
PulseWidth:(μs)120‐240
TimerControl:(mins)20minsforheat,60minsfortens
PowerSupply:Lithium‐polxmerrechargeablebattery
RemoteControl:One(1)CR2016ELithiumbattery
Size(DxWxH):18mmx191mmx90mm
Weight(includingbattery):Mainunit200g,remote17g
SafetyStandards:CE,R&TTE,EN300220‐2,EN301489‐3
EMC:EN60601‐1
Safety:EN60601‐1‐2
MadeinChina

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway8

WARNING!
•Thedevice’sTENStreatmentmaycauserhythmicdisturbancestotheheart.Donotusethe
deviceacrossorthroughyourchest.Ifyouaresusceptibletorhythmdisturbancesoftheheart,
useofthedevicemustbedoneunderthedirectionofaphysician.
•Useofthedevice’sTENStreatmentoveryourneckcouldcausemusclespasmsresultingin
airwayclosure,difficultyinbreathing,adverseeffectsonheartrhythmorbloodpressure.Do
notusethedevice’sTENStreatmentoveryourneck
•Useofthedevice’sTENStreatmentwhenyouareinthecareofaphysicianorhavehad
medicalorphysicaltreatmentforyourpain.
Consultwithyourphysicianbeforeusingthedevice’sTENStreatment.
•Continueduseofthedevice’sTENStreatmentwhenpaindoesnotimprove,becomesmore
severe,orlastsmorethanfivedaysmayindicateaseverecondition.Stopusingthedevice’s
TENStreatmentandconsultwithyourphysician.
• Useofthedevice’sTENStreatmentonthefollowingskinconditionsmaycauseaconditionto
becomeworse.Donotusethedevice’sTENStreatmentover,orinproximityto,theseskin
conditions:abnormalskin,skinthatisnotintact,uncleaned,unhealthy,openwounds,rashes,
swollen,red,infected,inflamedareas,skineruptions(e.g.,phlebitis,thrombophlebitis,varicose
veins),orcancerouslesions.
•Electricalstimulationduringcommonactivitiesmayincreasetheriskofinjury.Donotuse
thedevice’sTENStreatmentwheninthebathorshower,sleeping,driving,operatingof
machineryoranyactivityinwhichelectricalstimulationcanputyouatriskofinjury.
•Usingthedevicearoundelectronicmonitoringequipment(e.g.,cardiacmonitors,ECG
alarms)maycauseequipmentmalfunction.Donotusethisdevicearoundelectronic
monitoringequipment.
•Theeffect,andsafety,ofusingthedeviceonchildren,duringpregnancy,oruseacrossthe
headhasnotbeenevaluatedorestablishedandisunknown.Donotusethedeviceonchildren
orletchildrenhandlethedevice.Donotusethisdeviceifyouarepregnant,orsuspectthat
youarepregnant,unlessunderthedirectionofyourphysician.Donotapplythedeviceacross
yourhead.
PRECAUTION
•Usingthedevice’sTENStreatmentwhenyouhavesuspectedordiagnosedepilepsyorheart
diseasemaycauseunexpectedreactions.Alwaysconsultyourphysicianbeforeusingthe
device’sTENStreatment.


BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway9

12.ManufacturersDeclaration
GUIDANCEANDMANUFACTURER’SDECLARATION–ELECTROMAGNETICEMISSIONS
TheBackupBeltisintendedforuseintheelectromagneticenvironmentspecifiedbelow.
Emissions testComplianceElectromagnetic environment – guidance
RFemissionsCISPR11Group1TheBackupBeltusesRFenergyonlyforitsinternal
function.Therefore,itsRFemissionsareverylow
andarenotlikelytocauseanyinterferencein
nearbyelectronicequipment.
RFemissionsCISPR11ClassBTheBackupBeltaresuitableforuseinall
establishmentsincludingdomesticandthose
directlyconnectedtothepubliclowvoltage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

GUIDANCEANDMANUFACTURER’SDECLARATION–ELECTROMAGNETICIMMUNITY
TheBackupBeltisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror
theuseroftheBackupBeltshouldassurethatitisusedinsuchanenvironment.
IEC 60601 test level Compliance levelElectromagnetic
environment – guidance
Electrostaticdischarge
(ESD)IEC61000‐4‐2
±6kVcontact
±8kVair
±6kVcontact
±8kVair
Floorsshouldbewood,
concreteorceramictile.If
floorsarecoveredwith
syntheticmaterial,the
relativehumidityshouldbeat
least30%.
Electricalfast
transient/burstIEC
61000‐4‐4
±2kVforpower
supplylines±1kVfor
input/outputlines
±2kVforpower
supplylines
±1kVforinput/
outputlines
Mainspowerqualityshould
bethatofatypical
commercialorhospital
environment.
Surge
IEC61000‐4‐5
±1kVdifferential
mode
±1kVdifferential
mode
Mainspowerqualityshould
bethatofatypical
commercialorhospital

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway10

±2kVcommonmode ±2kVcommonmodeenvironment.
Voltagedips,short
interruptionsand
voltagevariationson
powersupplyinput
linesIEC610004‐11
<5%U
T
(>95%dipinUT)
for0.5cycle
40%U
T
(60%dipinUT)
for5cycles
70%U
T
(30%dipinUT)
for25cycles
<5%U
T
(>95%dipinUT)
for5sec
<5%U
T
(>95%dipinUT)for
0.5cycle
40%U
T
(60%dipinUT)for
5cycles
70%U
T
(30%dipinUT)for
25cycles
<5%U
T
(>95%dipinUT)
for5sec
Mainspowerqualityshould
bethatofatypical
commercialorhospital
environment.Iftheuserof
theBackupBeltrequires
continuedoperationduring
powermainsinterruptions,it
isrecommendedthatthe
BackupBeltbepoweredfrom
anuninterruptiblepower
supplyorabattery.

GUIDANCEANDMANUFACTURER’SDECLARATION–ELECTROMAGNETICIMMUNITY
TheBackupBeltisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror
theuseroftheBackupBeltshouldassurethatitisusedinsuchanenvironment.
ImmunitytestIEC60601test
level
Compliance
level
Electromagneticenvironment–guidance
ConductedRF
IEC61000‐4‐6
RadiatedRF
IEC61000‐4‐3
3Vrms
150kHzto80
MHz
3V/m
80MHzto2.5GHz
3Vrms
150kHzto
80MHz
3V/m
80MHzto
2.5GHz
PortableandmobileRFcommunicationsequipment
shouldbeusednoclosertoanypartoftheBackup
Belt,includingcables,thantherecommended
separationdistancecalculatedfromtheequation
applicabletothefrequencyofthetransmitter.
Recommendedseparationdistance
d=1.17√P150kHzto80MHz|d=1.17√P80MHzto
800MHz|d=2.33√P800MHzto2.5GHzwherePis
themaximumoutputpowerratingofthetransmitter
inwatts(W)accordingtothetransmitter
manufactureranddistherecommendedseparation
distanceinmetres(m).
FieldstrengthsfromfixedRFtransmitters,as
deter‐minedbyanelectromagneticsitesurvey,
*shouldbelessthanthecompliancelevelineach
frequencyrange.**
Interferencemayoccurinthevicinityofequipment
markedwiththefollowingsymbol:

BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway11


NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedby
absorptionandreflectionfromstructures,objectsandpeople.
*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
BackupBeltisusedexceedstheapplicableRFcompliancelevelabove,theBackupBeltshouldbeobserved
toverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,
suchasre‐orientingorrelocatingtheBackupBelt.
**Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.
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RECOMMENDEDSEPARATIONDISTANCESBETWEENPORTABLEANDMOBILERFCOMMUNICATIONS
EQUIPMENTANDTHEBACKUPRELIEFBEL
RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipmentandthe
BackupBelt.
Separationdistanceaccordingtofrequencyoftransmitterm
Ratedmaximumoutput
poweroftransmitterW
kHzto80MHzd=1.17√PMHzto800MHzd
=1.17√P
MHzto2.5GHzd
=2.33√P
0.010.120.120.23
0.10.370.370.74
11.171.172.33
103.703.707.37
10011.7011.7023.30
Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistance
dinmetres(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,where
Pisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmitter
manufacturer.
NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedby
absorptionandreflectionfromstructures,object.


BACKUPRELIEFBELTUSERMANUAL Ver.1.0
UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway12

FCCCaution
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
Note: 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 protection against harmful interference in a residential installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, 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 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 party responsible for
compliance could void the user's authority to operate the equipment.
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