SOLIS 1100 User manual

User Manual
Model 1100
US Pat. #9,037,269
Canada Pat. #2,824,697
EU Pat. # EP 2 837 405 B1
India Pat. Pending

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TABLE OF CONTENTS
 A Introducon Page 3
  GeneralInformaon
 B ImportantUseInformaon Page 3
  Indicaonsforuse
  Contraindicaons
  Usage
  Warnings
  Precauons
  AdverseReacons
C Operaon Page 8
  BaeryInformaon
  ConductorInformaon
  SkinPreparaon
  UseofControls
 D GengStarted Page 11
 E AddionalInformaon Page 11
Storage
Maintenance
  Troubleshoong
  WarrantyInformaon
  EnvironmentalandTechnical
  InformaonRegardingElectromagnecCompability(EMC)
  GuidanceandManufacturersDeclaraon–Electromagnec
  Immunity
F Glossary Page 20

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A Introducon
GeneralInformaon
TheSolisPainReliefSystemisahandheldNeuro-Modulatorwith
advancedtechnologyfordeeplasngreliefofpain.Itisportable
anddesignedtobeeasytouse.TheadvanceddesignofSOLIS
allowsyoutoapplypenetrangpressuredirectlytotheareaof
pain.Whenpressedagainsttheskin,precisegentleelectricpulses
triggernaturalbodyresponsestorelievepain.
B ImportantUseInformaon
IndicaonsForUse
Tobeusedfortemporaryreliefassociatedwithsoreandaching
musclesduetostrainfromexerciseornormalhouseholdand
workacvies.
Tobeusedforsymptomacreliefandmanagementofchronic,
intractablepainandreliefofpainassociatedwitharthris.
Contraindicaons
Donotusethisdeviceifyouhaveapacemaker,implanted
debrillator,orotherimplantedmetallicorelectronicdevice.Such
usecouldcauseshock,burns,electricalinterference,ordeath.
Donotusethisdeviceifyourpainsyndromeisundiagnosed.

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Usage
RefertotheOperaonseconofthisdocumentortheSolis
PainReliefSystemQuickStartGuideforsetupandtreatment
instrucons.
Warnings
• Ifyouareinthecareofaphysician,consultyourphysician
beforeusingthisdevice.
• Ifyouhavehadmedicaltreatmentforyourpain,consultwith
yourphysicianbeforeusingthisdevice.
• Ifthepaindoesnotimproveorbecomesmoreacute,stop
usingthedeviceandconsultwithyourphysician.
• Donotuseorplacethisdeviceonyourhead.
• Donotapplysmulaonoverthefront(throatarea)and
thesidesofyourneckbecausethiscouldcausesevere
musclespasmsresulnginclosureoftheairway,diculty
inbreathing,oradverseeectsonheartrhythmorblood
pressure.
• Donotuseoverthecarodsinusarea(alongthesideofyour
neckbelowyourjaw).Smulaonofthecarodsinusmaybe
hazardous
• Donotapplysmulaonacrossyourchestorplaceboth
hands,arms,orngersonConductorsatthesameme,
becausetheintroduconofelectricalcurrentintothechest
maycauserhythmdisturbancestoyourheart,whichcouldbe
lethal.

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• Thisdevicecanaecttheoperaonofdemandtypecardiac
pacemakersandisnotrecommendedforthosewithknown
heartdiseasewithoutconsulngphysician.
• Donotapplysmulaonoveropenwoundsoropenrashes,or
overswollen,red,infected,orinamedareasorskinerupons
(e.g.,phlebis,thrombophlebis,varicoseveins).
• Donotapplysmulaonover,orinproximityto,cancerous
lesions.
• Donotapplysmulaoninthepresenceofelectronic
monitoringequipment(e.g.,cardiacmonitors,ECGalarms),
whichmaynotoperateproperlywhentheelectrical
smulaondeviceisinuse.
• Donotapplysmulaonwhenyouareinthebath,showeror
wateringeneral.
• Donotapplysmulaonwhilesleeping;orwhiledriving,
operangmachinery,orduringanyacvityinwhichelectrical
smulaoncanputyouatriskofinjury.
• Applysmulaononlytonormal,intact,clean,healthyskin.
• Conductorsshouldnotbeplacedovertheeyes,inthemouth,
orinternally.
• Donotusethisdeviceduringpregnancy.
• Donotusethisdeviceifthedevicehousinghasbeen
damaged.
• Donotusethisdeviceifthesourceofyourpainisnotknown.

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• Keepoutofreachofchildren.
• Donotusethisdeviceinthepresenceofstrong
electromagnecelds.
Precauons
• Neuro-Modulaonisnoteecveforpainofcentralorigin,
includingheadache.
• Neuro-Modulaonisnotasubstuteforpainmedicaonsand
otherpainmanagementtherapies.
• Neuro-Modulaonhasnocuravevalue.
• Neuro-Modulaonisasymptomactreatmentand,assuch,
suppressesthesensaonofpainthatwouldotherwiseserve
asaprotecvemechanism.
• Thelong-termeectsofelectricalsmulaonareunknown.
• Sincetheeectsofsmulaonofthebrainareunknown,
theunit’sConductorsshouldnotbeappliedanywhereonthe
head.
• Thesafetyofelectricalsmulaonduringpregnancyhasnot
beenestablished.
• Someusersmayexperienceskinirritaonorhypersensivity
duetotheelectricalsmulaonorelectricalconducvegel.
• Userswithsuspectedordiagnosedheartdiseaseandepilepsy
shouldfollowprecauonsrecommendedbytheirphysicians.
• Usecauonifyouhaveatendencytobleedinternally,suchas
followinganinjuryorfracture.

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• Donotuseaerrecentsurgicalprocedureswhensmulaon
maydisruptthehealingprocess.
• Usecauonifsmulaonisappliedoverthemenstruang
uterus.
• Usecauonifsmulaonisappliedoverareasofskinthatlack
normalsensaon.
• Keepthisdeviceoutofthereachofchildren.
• Usethisdeviceinaccordancewiththisinstruconmanual.
• Usethisdeviceonlywiththeconductorsandaccessories
recommendedbythemanufacturer.
AdverseReacons
• Userswithsensiveskinmayexperienceskinirritaon
beneaththesmulaonconductors.
• Youshouldstopusingthedeviceandshouldconsultwithyour
physiciansifyouexperienceanyadversereaconsfromthe
device.
• Youmayexperienceheadacheandotherpainfulsensaons
duringorfollowingtheapplicaonofelectricalsmulaon
neartheeyesandtotheheadandface.

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C Operaon
BaeryInformaon
Your new Solis is shipped with a fresh 9 Volt Duracell Alkaline
Baeryinstalled.BEFOREUSING,openthebaerycompartment
byslidingthelatchwithngersandremovetheplascinsulang
tab.
Withnormaluse,thebaeryinyourSolisPainReliefSystem
shouldlastforupto70hoursofoperaonandgiveyoulong
lasngservice.Werecommendthatthebaerybereplacedwith
afreshbaeryatregularintervalstoreducethepossibilityof
baeryleakage.Thebaeryislocatedinthehandleandcanbe
accessedbyremovingthebaerycompartmentdoor.Removethe
baeryduringlongtermstoragetopreventdamagecausedby
leakagefromthebaery.AlwaysturnthePowerSwitchto“O”
beforeremovingthebaery.Replacewithafresh9VDuracell
alkalinebaeryandbecarefultoobservethepolaritywhen
installinganewbaery.
ConductorInformaon
TheSolisPainReliefSystemhasself-containedstainless-steel
conductors.Withlongtermuse,itisnormalforthestainless-steel
conductorstotarnish.Thiswillnotaecttheoperaonofyour
SolisPainReliefSystem.Ifdesired,anytarnishcanberemoved

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withhouseholdstainlesssteeltarnishremover.Useanalcohol
wipeoruseSanizideProtokeepconductorscleanbeforeand
aeruse.
Cleanandmoistentheskinareawithadamptowelandthen
rmlypresstheSolisPainReliefSystemconductorendagainst
theskin.Ifconduconisinsucientandtheuserdoesn’tfeelthe
therapy,rubasmallamountoftheParkerSpectra360SaltFree
Hypoallergenicgelsuppliedwiththeunitontotheskinasneeded
andreapplymoistureusingadamptowel.Donotuseanyother
typeofgelbutsaltfree.
SkinPreparaon
ByproperlycaringforskinpriortousingtheSolisPainRelief
System,youwillallowmoresmulaontoreachthetargeted
nerves.Ifskinirritaondevelops,disconnueusingyourSolisPain
ReliefSystem,andconsultwithyourphysician.
Toproperlycareforyourskin:
• Washallskinareasitesthatwillbeincontactwiththe
conductorswithmildsoapandwaterbeforeusingtheSolis
PainReliefSystem.
• Moistentheskinpriortoeachuse.
• Trimexcessbodyhairfromconductorsiteforcomfortas
needed.
• Donotuseoncut,brokenorirritatedskin.

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Use of Controls
TheSolisPainReliefSystemcontrolsaredesignedtobesimple
andeasytooperate.Refertothediagrambelowforthelocaon
ofthecontrols.
Intensity:Athumbdiallocatedonthesideprovidesconnuous
adjustmentoftheintensityoftherapyduringtreatmentandis
labeled0-8.PresettheIntensitytonomorethan”0”priorto
placingconductorsagainsttheskin.Aeruse,reducetheIntensity
tozero.
On-O:Mainpowerswitch.
Pulse Width:ThePulseWidthSwitchselectseither150or230
microsecond(µS)pulsewidth.The230microsecondseng
usuallyproducesamoreintensetreatmentexperienceandcan
lowerthetotaltreatmentmeneeded.
Polarity:ThePolaritySwitchallowsyoutochoosethepolarityof
theconductorsforbestresults.Occasionallyduringuse,theremay

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beuncomfortablemusclevibraonsandachangeinpolaritywill
usuallyminimizeoreliminateanydiscomfort.
D GengStarted
 PleaserefertotheQuickStartGuide
E AddionalInformaon
Storage
WhenyourSolisPainReliefSystemisnotinuse,storeitinasafe
dryplaceawayfromchildren.Forlongtermstorage,removethe
baeryandkeepindrystorageareaawayfromsunlightatnormal
roomtemperature.
Removebaerybeforestoring
Maintenance
• Neverimmersethisdeviceinwater,alcoholorotheruids,
sincethiscouldseriouslydamagetheinternalelectronics.
• Avoidusingcleaninguidsorsolventstoremovestainsordirt.
Suchliquidsmaydamagetheplasc.
• CleanconductorswithanalcoholwipeorSanizidePro
dependingonuserneeds.

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• Useonlyfreshbaeriesandreplaceasnecessary.
• TherearenoreplaceablepartsinsidetheSolisPainRelief
System.
TroubleshoongGuide
Problem PossibleCause CorrecveAcon
Lowornosmulaonfelt ▪LowBaery
▪LowIntensityseng
▪Dryskin
▪Addmoisturetoskin
▪AddSpectra360gel
▪IncreaseIntensity
▪Reposionelectrodes
▪Replacebaery
Intermient
Smulaon
▪Poorbaerycontact
▪LowIntensityseng
▪Dryskin
▪Addmoisturetoskin
▪AddSpectra360gel
▪IncreaseIntensity
▪Reposionelectrodes
▪Replacebaery
Smulaonnot
powerfulenough
▪LowBaery
▪LowIntensityseng
▪Dryskin
▪Addmoisturetoskin
▪AddSpectra360gel
▪IncreaseIntensity
▪Reposionelectrodes
▪Replacebaery
Smulaonineecveagainst
pain
▪Electrodeplacement
▪Intensitytoolow
▪Dryskin
▪Addmoisturetoskin
▪AddSpectra360gel
▪IncreaseIntensity
▪Reposionelectrodes
▪Replacebaery
LEDlightdoesnotcomeon ▪Deadbaery ▪Replacebaery
LEDlightcomesonbutno
smulaon
▪LowBaery
▪LowIntensityseng
▪Dryskin
▪Addmoisturetoskin
▪AddSpectra360gel
▪IncreaseIntensity
▪Reposionelectrodes
▪Replacebaery
Musclessuecontracts,
vibrates,cramps,orbecomes
painfulduringtreatment
▪Intensitytoohigh
▪Polaritysengincorrect
▪Electrodemisalignmentwith
respecttomuscle
▪ReduceIntensity
▪ChangePolaritySeng
▪Rotatedeviceelectrode
end over pain point to a
newposion

13
Donottrytorepairadefecvedevice.Therearenoserviceable
partsintheSolisPainReliefSystem.
Thefactorywarrantywillbevoidedifthereisevidenceof
disassembly.
WarrantyInformaon
TheSolisPainReliefSystemcarriesaoneyearmanufacturer’s
warrantyfromthedateofpurchase.Thewarrantycoversboth
partsandlaborforanyproblemsthatarisefromdefectsor
faultsinmanufacturing.Thewarrantydoesnotapplytodamage
resulngfromfailuretofollowtheoperanginstrucons,
accidents,abuse,alteraonordisassemblybyunauthorized
personnel.
Whenreturningunderwarranty,youwillneedtoobtaina
ReturnMaterialAuthorizaonfromthemanufacturer.Keepyour
purchasereceiptshowingthedateofpurchase.

14
Environmental and Technical
Foruseinnormaloceorhomeenvironment
Dimensions 6X3.875inches
Weight 3.4oz.
Waveform AsymmetricalBi-phaseSquarePulse
Pulse Rate 40Hz
Pulse Width 150or230microseconds(selectable)
Peak Current 0-80milliamps(500ohms)
PeakVoltage 0-40V(500ohm)
MaximumChargeper
Pulse 20Microcoulombs
Power Supply 9VoltAlkalineBaery
Conductors StainlessSteel
Safety tests ComplieswithIEC60601-1,IEC60601-
1-2,andIEC60601-2-10
FDA
DraGuidanceforIndustryandSta:Class
IISpecialControlGuidanceDocument:
TranscutaneousElectricalNerveSmulator
forPainRelief(April5,2010)

15
InformaonRegardingElectromagnecCompability
(EMC)
• MedicalElectricalEquipmentneedsspecialprecauons
regardingEMCandneedstobeusedandputintoservice
accordingtoEMCinformaonprovidedinthismanual.
• PortableandmobileRadioFrequency(RF)communicaons
equipmentcanaectMedicalElectricalEquipment.
• Theuseofaccessories,transducers,andcablesotherthan
thosespeciedbythemanufacturermayresultinincreased
emissionsordecreasedimmunityoftheSolisPainRelief
System.
• TheSolisPainReliefSystemshouldnotbeusedadjacentto
orstackedwithotherequipment.Ifadjacentorstackeduseis
necessary,theSolisPainReliefSystemshouldbeobservedto
verifynormaloperaonintheconguraoninwhichitwillbe
used.
Donotusenearmicrowaveequipment.
Dimensions 6X3.875inches
Weight 3.4oz.
Waveform AsymmetricalBi-phaseSquarePulse
Pulse Rate 40Hz
Pulse Width 150or230microseconds(selectable)
Peak Current 0-80milliamps(500ohms)
PeakVoltage 0-40V(500ohm)
MaximumChargeper
Pulse 20Microcoulombs
Power Supply 9VoltAlkalineBaery
Conductors StainlessSteel
Safety tests ComplieswithIEC60601-1,IEC60601-
1-2,andIEC60601-2-10
FDA
DraGuidanceforIndustryandSta:Class
IISpecialControlGuidanceDocument:
TranscutaneousElectricalNerveSmulator
forPainRelief(April5,2010)

16
GuidanceandManufacturersDeclaraon–
ElectromagnecImmunity
TheSolisPainReliefSystemisintendedforuseinthe
electromagnecenvironmentspeciedbelow.Thecustomeror
useroftheSolisPainReliefSystemshouldassurethatitisusedin
suchanenvironment.
Table1:GuidanceandManufacturersDeclaraons
-ElectromagnecEmissions
TheSolisPainReliefSystemisdesignedtoproduceverylowlevelsofradio
frequency(RF)emissions(interference),tobeimmunetotheeectsof
interferenceproducedbyotherequipmentoperanginthevicinity,andtobe
immunetodamageduefromelectrostacdischarge,allwhenoperangina
domescorclinicalenvironment.Formoreinformaon,pleaserefertothe
tablesbelow.
Emissions
Test Compliance ElectromagnecEnvironmentGuidance
RF
Emissions
CISPR11
Group1
TheSolisPainReliefSystemusesRF
energyonlyforitsinternalfuncon.
ThereforeitsRFemissionsareverylow
andarenotlikelytocauseanyinterfer-
enceinnearbyelectronicequipment.
RF
Emissions
CISPR11
ClassB
TheSolisPainReliefSystemissuitable
foruseinallestablishmentsincluding
domescestablishmentsandthosedi-
rectlyconnectedtothepubliclowvolt-
agepowersupplynetworkthatsupplies
buildingsusedfordomescpurposes.

17
Table2:Guidanceandmanufacturer’sdeclaraon
-electromagnecimmunity
TheSolisPainReliefSystemisintendedforuseintheelectromagnec
environmentspeciedbelow.Thecustomerortheuser
shouldassurethatitisusedinsuchenvironment
Immunity
test
IEC 60601
testlevel
Compliance
level
Electromagnec
Environment
guidance
Electrostac
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le.
Ifoorsarecoveredwith
synthecmaterial,the
relavehumidityshould
beatleast30%
PowerFrequency
(50/60Hz)
Magnec
Field
IEC61000-4-8
3A/m 3A/m
Powerfrequencymag-
neceldsshouldbeat
levelscharacteriscofa
typicallocaoninatypical
commercialorhospital
environment

18
Table3:Guidanceandmanufacturer’sdeclaraon
-electromagnecimmunity
TheSolisPainReliefSystemisintendedforuseintheelectromagnecenvironmentspecied
below.Thecustomerorusershouldassurethatitisusedinsuchanenvironment.
Immunity
test
IEC 60501
Testlevel
Compliance
level Electromagnecenvironmentguidance
PortableandmobileRFCommunicaons
equipmentshouldbeusednoclosertoany
partofthedevice,includingcables,thanthe
recommendeddistancecalculatedfromthe
equaonapplicabletothefrequencyofthe
transmier’srecommendedseparaondistance
Radiated
RFIEC
61000-4-3
3V/m
80MHzto
2.5GHz
3V/m
80MHzto800MHz
d=1.2√P
800MHzto2.5GHz
d=2.3√P
Where“P”isthemaximumoutputpowerrang
ofthetransmierinWas(W)accordingto
thetransmiermanufacturerand“d”isthe
recommendedseparaondistanceinmeters
“m”.FieldstrengthfromxedRFtransmiersas
determinedbytheelectromagnecsitesurvey,a.
shouldbelessthanthecompliancelevelineach
frequencyrange.b.interferencemayoccurinthe
vicinityofequipmentmarkedwiththefollowing
symbol:
NOTE1:At80MHzto800MHz,thehigherfrequencyrangeapplies.
NOTE2:Theseguidelinesmaynotapplyinallsituaons.Electromagnecpropagaonisaectedbyabsorpon
andreeconfromstructures,objectsandpeople.
a.Fieldstrengthsfromxedtransmiers,suchasbasedstaonsforradio(cellularandcordless)andland
mobileradios,amateurradio,AMandFMradiobroadcast,andTVbroadcastcannotbepredictedtheorecally
withaccuracy.ToassesstheelectromagnecenvironmentduetoxedRFtransmiers,anelectromagnecsite
surveyshouldbeconsidered.IfthemeasuredeldstrengthinthelocaoninwhichtheSolisPainReliefSystem
isusedexceedstheapplicableRFcompliancelevelabove,theSolisPainReliefSystemshouldbeobservedto
verifynormaloperaon.Ifabnormalperformanceisobserved,addionalmeasuresmaybenecessary,suchas
reorienngorrelocangthedevice.
b.Overthefrequencyrangeof150KHzto80MHz,eldstrengthsshouldbeless
than3V/m.