20258002FCC Backup Belt User Manual

 

BACKUPRELIEFBELTUSERMANUAL Ver.1.0 ProductName:BACKUPBELT ModelNumber:002 Companyname:EXPAINAS Address:KarlJohansgate130154OsloNorway ContactName:ThomasJakobsen Telephonenumber:+4797035997 Faxnumber:+4792040756 Email:thomas@expain.no UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway BACKUPRELIEFBELTUSERMANUAL Ver.1.0 Contain 1.Parts&Controls............................................................................................................................1 PARTS.........................................................................................................................................1 CONTROLS.................................................................................................................................1 2.Introduction..................................................................................................................................1 3Beforeuse......................................................................................................................................2 4Supportfunctionality.....................................................................................................................2 5TENSfunctionality..........................................................................................................................3 APPLYINGTHEGELPADSTOTHEMAINUNIT...........................................................................3 HOWDOESITWORK.................................................................................................................4 TREATMENTRECOMMENDATIONS...........................................................................................4 CONDUCTINGATENSTREATMENT...........................................................................................4 6HEATfunctionality..........................................................................................................................5 CONDUCTINGAHEATTREATMENT...........................................................................................5 7RemovingtheBackupBelt.............................................................................................................5 8Batteries&charging.......................................................................................................................6 9Maintenanceandstorage..............................................................................................................6 10TechnicalSpecifications................................................................................................................7 11Safetyinformation........................................................................................................................7 12.ManufacturersDeclarction.........................................................................................................9 UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway Ver.1.0 BACKUPRELIEFBELTUSERMANUAL 1.Parts&Controls PARTS 1. Belt a. Innerbelts(right&left) b. Beltbackplate c. Magneticconnectors d. Tensioningbelts(right&left) 2. Remote 3. Mainunit a. ElectrodeArea:Surfacewhere thegelpadsareplacedb. Electronicshousing 4. USBcable&Charger 5. Gelpads 6. Manual CONTROLS 7. MainunitOn/Off 8. MainunitIndicatorLight 9. RemoteunitOn/Off 10. TENSOn/+button 11. TENSOff/button 12. HEATOn/Offbutton 13. TENSsignallight 14. HEATsignallight 2.Introduction CongratulationsonyourpurchaseoftheBackupBelt.Itisauniquewirelessremotecontrolled pain relief device incorporating active heating, structural support and TENS technology to UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 1 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 specificallytargetbackpain. Thisinnovativedeviceissafe,drugfree,easytouse,discreetandcomfortabletowear,andmost importantlyallowsyoutocontrolyourpaintomaintainanactivelifestyle. 3Beforeuse Your Backup Belt has been designed with the home user in mind. Please consult the safety precautionsandcontraindicationsinthismanualpriortouse. Beforeusingthemainunitthefirsttimepleasechargethemainunit.Inserttheusbcableto thecharger.Plugthechargerintothemainsmakingsurebeforethatthechargeriscompatible tothemainsinyourcurrentlocation.Thenconnectthemainunit.Themainunitindicator lightwillflashgreenevery5thsecondduringcharging.Theunitisfullychargedafter2hrs

(2000mAh). 4Supportfunctionality ThesupportfunctionofyourBackupBeltiscompletelyanalogandreadytouse.Putonthebelt likethis:

1. 1.Makesurethebeltisfacingtherightway.Themagneticconnectorsshouldfacetowards yourbodyanddown 2. Thebeltlengthcanbeadjustedbymovingtheinnerright&leftbeltalongthebeltbackplate, fasteningbymeansofthevelcro. 3. Toinsertthemainunitinsertthenotchinthetopofthemainunitintothematchingtabon thebeltbackplate.Thenpressmainunitthroughtheopeningallowingthemagnetic connectorsonthemainunit&beltbackplatetoconnect. UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 2 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 4. Holdthebackplatewithmainunittowardsyourlowerback.Ifusingthegelpadsseenext pagefordetailedinstructions.Grabtheinnerfasteningbeltandwrapitaroundyourbody. TightencomfortablyandfastenwiththeVelcro.Righthandsidegoesoverthelefthandside. 5. Totightenthesupportingbeltgrabbothoutertensioningbeltsandpullthemuntilyoufeel youhavedesiredsupport.FastenwiththeVelcro.Righthandsidegoesoverthelefthandside heretoo. 5TENSfunctionality BeforeusingtheTENSfunctionalityofyourBackupBeltyouwillneedtoapplythegelpadstothe mainunit,Insertthemainunitinthebeltandpreparethedeviceforatreatment. APPLYING THE GEL PADS TO THE MAIN UNIT Thegelpadsareintendedforsinglepersonuse.Theywilllast,dependingonskintype,oils,and pH levels, approximately two to five applications. Replace the gel pads when they no longer adherecompletely.Followthesestepstoapplythegelpads:

UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 3 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 1. Trim,notshave,excessivehaironthetreatmentarea. 2. Washtheskinanddrycompletely 3. Separatethetwogelpads. 4. RemovethefilmwithprintreadingELECTRODEfromthesidebeingappliedtotheelectrode area.Thisfilmisthesmallestofthetwo.Donotremovetheprotectivelinerontheskinside yet. 5. Aligntheshapeofthefirstgelpadwiththeelectrodearea.Applythegelpadontothe electrodeareaandfirmlypressacrosstheentiresurfacetoensuregoodadhesion. 6. Repeatsteps35forthesecondgelpad. HOW DOES IT WORK Tenstreatmentworksintwoways.Itstimulatesnervesthatnormallycarriespainsignalsthus blockingthese(closingthepaingate).Italsoreleasesendorphinsasiffromexercise, endorphinsisthebody`snaturalpainkillers. TREATMENT RECOMMENDATIONS Youcanleavethedeviceinpositionformultipletreatmentsduringtheday.Itwill automaticallyturnOffafterone(1)houroftreatment.Ifnotreatmentisactivetheunitwillturn offcompletelyafter15minutes. Itisrecommendedyouwaitaminimumof30minutesbetweentreatments. CONDUCTING A TENS TREATMENT Alwaysreadthesafetywarningsbeforeconductingatreatment.Followthesestepstoconducta treatment:

1. Removetheprotectivelinersfromtheskinsideofthegelpadsbyslowlypeelingtheliner diagonallyfromaninsidecornertotheoppositeoutsidecorner. Important!Avoidcontactof thegelpadwithotherobjects.Contactwithotherobjectsmayaffectthepadsadhesion properties.Savethelinersforstorageofthedevice. 2. Alignthecenterofthedeviceoverthespineandplacethedeviceonyourbackintheareaof pain.Ifyoucannotplacethedeviceproperly,askanotherpersonforassistance.Important!Do notapplythegelpads/electrodesdirectlyoverthespine. 3. PresstheOn/Offbuttononthemainunit.TheLEDwillflashgreenfor10secondsindicating thedeviceisreadyforuse. 4. PresstheON/OFFbuttonontheremote.Bothsignallightswillblinktwicetosignalremoteis on.Thenpressthe+buttonontheremotecontroltobeginthetreatment.TheTENSsignal lightontheremotewillblinkoncetoindicatesignalissentfromremote.Note:TheLEDonthe mainunitwillflashbluefor10secondstoindicateTENStreatmentisactivated. 5. Pressthe(+/)buttonstoincreaseordecreasetheintensityofthestimulationuntilitisata comfortablelevel.Thereare4levels. 6. PresstheON/OFFbuttonontheremotecontroltostopthetreatmentatanytime.Both indicatorlightswillblinktwicetosignalremoteisoff.Treatmentwillautomaticallystopafter1 hourofinactivity(notpressinganybuttons)Alternativelypressthebuttonseveraltimes toreduceintensityandfinallyturnoffthetreatment. UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 4 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 Note:Ifatreatmentisstoppedandrestartedthetreatmentwillrestartatthefirststage,and willrunforanewfullhour.Note:Turningtheremoteoffwillalsoturnthemainunitoff!To resumetreatmentbothmainunit&remotemustbeturnedbackonseperately. 6HEATfunctionality CONDUCTING A HEAT TREATMENT 1. PresstheHEATbuttonontheremote.Theheatsignallightontheremotewillblinkonceto showthatasignalissenttothemainunit. 2. Thebeltwillstarttheheatingandlastfor20minutesbeforeautomaticallyturningoff.The mainunitindicatorlightwillblinkyellowfor10secondstoindicateaheattreatmenthas started.Theheatingtemperatureis42C.Itwilltakeabitoftimebeforeyoucanfeelthe heatafteractivation.Theunitwillhaveenoughbatteryfor8fullHEATtreatmentsperfull charge. 3. TostoptheHEATtreatmentbeforethe20minuteshavepassedsimplypresstheHEAT buttonontheremoteonemoretime.AlternativelypressandholdtheremoteON/OFF buttontoturnoffbothremoteandmainunitinstantly. 7RemovingtheBackupBelt 1. Aftertreatment,orwhenyouwanttoremovethedevice,loosenthesupportbelt,graspthe edgeofthedeviceandgelpadtoensurethegelpaddoesnotstayontheskin.Slowlypeelthe deviceawayfromtheskin. 2. Align,andplacetheprotectivelinersbackonthegelpads.Ensurethepadsarecompletely covered.Important!Donotremovethedeviceuntiltenstreatmenthasstopped. UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 5 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 8Batteries&charging When main unit recharge is needed the main unit indicater will flash red: Recharge with USB charger. Whentheremotecontrolislowonbatterynoindicationswilllightupifbuttonsarepressed. ToREPPLACETHEREMOTECONTROLBATTERY:

1.Gentlysnapoffthefrontcoverwherethe+& buttonsare,youwillthensee2screws. 2.UnscrewthesewithincludedscrewdrivertoaccessthecatteryonthebackofthePCB. 3.Slidetheoldbatteryout,andslideanew(1)CR2016Elithiumbatteryintotheslot.Note:The(+) isfacingupward Reversetheprocesstoclosetheremote. 9Maintenanceandstorage Cleanthedeviceusingadampclothandmildsoap.Gentlywipeclean. Theright&leftinnerbeltscanbewashedat30degrees.DoNOTwashthebeltbackplateasit containselectronicsfortheheatingfunctionality. Donotsubmergetheproductinliquid. Thedeviceshouldbeoperated,transportedandstoredattemperaturesbetween10Cand40 C,withrelativehumiditybetween30%85%,andAtmosphericPressurelimitationof500hPato 1060hPa. Allvalueshave+/10%tolerance. Storethedevice,remotecontrolandgelpadsintheoriginalpackagingwhennotinuse. Ifthedeviceisnotworkingproperly,stopusingimmediately.Donotdisassembleormodifythe device.ContactUnikiaCustomerServiceatpost@unikia.com UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 6 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 10TechnicalSpecifications Technicalspecifications Channels:Singlechannel Waveform:Asymmetricbiphasicsquarepulse PulseAmplitude:0~110mA=0~55volts,adjustable(at500ohmload) PulseFrequency:(Hz)5120 PulseWidth:(s)120240 TimerControl:(mins)20minsforheat,60minsfortens PowerSupply: Lithiumpolxmerrechargeablebattery RemoteControl:One(1)CR2016ELithiumbattery Size(DxWxH):18mmx191mmx90mm Weight(includingbattery):Mainunit200g,remote17g SafetyStandards:CE,R&TTE,EN3002202,EN3014893 EMC:EN606011 Safety:EN6060112 MadeinChina WARRANTY COMPANYSHALLNOTBELIABLEINANYEVENTFORINCIDENTALORCONSEQUENTIALDAMAGES. Unikia (Company) warrants the Backup Belt (Product) is free of defects in materials and workmanship.Thiswarrantyshallremainineffectasperthelegislationofthecountryinwhich theunitwaspurchased. 11Safetyinformation INDICATIONSFORUSE For temporary reliefof pain associatedwith sore and aching muscles in the lower back dueto strainfromexerciseornormalhouseholdandworkactivities. SAFETYCONTRAINDICATIONSDonotusetheTENStreatmentonthisdeviceifyouhaveacardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use couldcauseelectricshock,burns,orelectricalinterferenceordeath. UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 7 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 WARNING!

ThedevicesTENStreatmentmaycauserhythmicdisturbancestotheheart.Donotusethe deviceacrossorthroughyourchest.Ifyouaresusceptibletorhythmdisturbancesoftheheart, useofthedevicemustbedoneunderthedirectionofaphysician. UseofthedevicesTENStreatmentoveryourneckcouldcausemusclespasmsresultingin airwayclosure,difficultyinbreathing,adverseeffectsonheartrhythmorbloodpressure.Do notusethedevicesTENStreatmentoveryourneck Use of the devices TENS treatment when you are in the care of a physician or have had medicalorphysicaltreatmentforyourpain. ConsultwithyourphysicianbeforeusingthedevicesTENStreatment. ContinueduseofthedevicesTENStreatmentwhenpaindoesnotimprove,becomesmore severe,orlastsmorethanfivedaysmayindicateaseverecondition.Stopusingthedevices TENStreatmentandconsultwithyourphysician. UseofthedevicesTENStreatmentonthefollowingskinconditionsmaycauseaconditionto become worse. Do not use the devices TENS treatment over, or in proximity to, these skin conditions:abnormalskin,skinthatisnotintact,uncleaned,unhealthy,openwounds,rashes, swollen,red,infected,inflamedareas,skineruptions(e.g.,phlebitis,thrombophlebitis,varicose veins),orcancerouslesions. Electricalstimulationduringcommonactivitiesmayincreasetheriskofinjury.Donotuse the devices TENS treatment when in the bath or shower, sleeping, driving, operating of machineryoranyactivityinwhichelectricalstimulationcanputyouatriskofinjury. Using the device around electronic monitoring equipment (e.g., cardiac monitors, ECG alarms) may cause equipment malfunction. Do not use this device around electronic monitoringequipment. Theeffect,andsafety,ofusingthedeviceonchildren,duringpregnancy,oruseacrossthe headhasnotbeenevaluatedorestablishedandisunknown.Donotusethedeviceonchildren orletchildrenhandlethe device.Donotusethisdeviceifyouarepregnant,orsuspectthat youarepregnant,unlessunderthedirectionofyourphysician.Donotapplythedeviceacross yourhead. PRECAUTION UsingthedevicesTENStreatmentwhenyouhavesuspectedordiagnosedepilepsyorheart disease may cause unexpected reactions. Always consult your physician before using the devicesTENStreatment. UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 8 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 12.ManufacturersDeclaration GUIDANCEANDMANUFACTURERSDECLARATIONELECTROMAGNETICEMISSIONS TheBackupBeltisintendedforuseintheelectromagneticenvironmentspecifiedbelow. Emissions test Compliance Electromagnetic environment guidance RFemissionsCISPR11 Group1 RFemissionsCISPR11 ClassB Harmonic 6100032 emissions IEC Notapplicable Notapplicable Voltagefluctuations/

flickeremissions IEC6100033 TheBackupBeltusesRFenergyonlyforitsinternal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearbyelectronicequipment. in all The Backup Belt are suitable for use establishments including domestic and those directlyconnectedtothepubliclowvoltagepower supply network that supplies buildings used for domesticpurposes. GUIDANCEANDMANUFACTURERSDECLARATIONELECTROMAGNETICIMMUNITY TheBackupBeltisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror theuseroftheBackupBeltshouldassurethatitisusedinsuchanenvironment. IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge

(ESD)IEC6100042 6kVcontact 8kVair 6kVcontact 8kVair Electrical transient/burst 6100044 fast IEC 2 kV for power supplylines1kVfor input/outputlines for power kV 2 supplylines for kV 1 outputlines input/

Surge IEC6100045 1kVdifferential mode 1kVdifferential mode Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relativehumidityshouldbeat least30%. Mains power quality should typical be commercial hospital environment. that or of a Mains power quality should be typical hospital commercial that or of a UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 9 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 2kVcommonmode 2kVcommonmode environment. dips, short Voltage and interruptions voltage variations on powersupplyinput linesIEC61000411 U T

<5%

(>95 % dip in UT) for0.5cycle U T

<5%

(>95%dipinUT)for 0.5cycle U T 40%

(60 % dip in UT) for5cycles U T 70%

(30 % dip in UT) for25cycles U T

<5%

(>95%dipinUT) for5sec U T 40%

(60%dipinUT)for 5cycles U T 70%

(30%dipinUT)for 25cycles U T

<5%

(>95%dipinUT) for5sec a of or that Mains power quality should be typical commercial hospital environment. If the user of the Backup Belt requires continued operation during power mains interruptions, it is recommended that the BackupBeltbepoweredfrom an uninterruptible power supplyorabattery. GUIDANCEANDMANUFACTURERSDECLARATIONELECTROMAGNETICIMMUNITY TheBackupBeltisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror theuseroftheBackupBeltshouldassurethatitisusedinsuchanenvironment. Immunitytest IEC 60601 level test Compliance level Electromagneticenvironmentguidance ConductedRF IEC6100046 RadiatedRF IEC6100043 to 80 3Vrms 150 kHz MHz 3V/m 80MHzto2.5GHz 3Vrms 150kHzto 80MHz 3V/m 80MHzto 2.5GHz 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. Recommendedseparationdistance d=1.17P150kHzto80MHz|d=1.17P80MHzto 800MHz|d=2.33P800MHzto2.5GHzwherePis themaximumoutputpowerratingofthetransmitter in watts transmitter manufactureranddistherecommendedseparation distanceinmetres(m). Field strengths fixed RF transmitters, as from determined by an electromagnetic site survey,

*should be less than the compliance level in each frequencyrange.**

Interference may occur in the vicinity of equipment markedwiththefollowingsymbol:

(W) according the to UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 10 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorptionandreflectionfromstructures,objectsandpeople.

*Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesand 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 electromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthinthelocationinwhichthe BackupBeltisusedexceedstheapplicableRFcompliancelevelabove,theBackupBeltshouldbeobserved toverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary, suchasreorientingorrelocatingtheBackupBelt.

**Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m. RECOMMENDEDSEPARATIONDISTANCESBETWEENPORTABLEANDMOBILERFCOMMUNICATIONS EQUIPMENTANDTHEBACKUPRELIEFBEL RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipmentandthe BackupBelt. Separationdistanceaccordingtofrequencyoftransmitterm Rated maximum output poweroftransmitterW kHzto80MHzd=1.17P MHzto800MHzd MHzto2.5GHzd

=1.17P

=2.33P 0.01 0.1 1 10 100 0.12 0.37 1.17 3.70 11.70 0.12 0.37 1.17 3.70 11.70 0.23 0.74 2.33 7.37 23.30 Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistance dinmetres(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorptionandreflectionfromstructures,object. UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 11 BACKUPRELIEFBELTUSERMANUAL Ver.1.0 FCCCaution 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. UnikiaASSandakerveien24c,Byggc1,0473Oslo,Norway 12