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  3. REVOLVE System

Allergan REVOLVE System User manual

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REVOLVE™ ADVANCED ADIPOSE SYSTEM
USER MANUAL: REVOLVE
TM
System
Guidelines for Tissue Temperature Management:
1. UseONLYpre-warmedsoluonsforwashing/ltering,warmedtotemperaturerangeof37°C-39°C(98.6-102.2°F),per
IFU.Cooleruidscausetheadiposetothickenandcongeal.Ifroomtemperatureuidsareusedtowash,ortheadipose
isallowedtocoolformorethanafewminutes,thecongealedadiposemayclogthemeshlter.Ulizingsoluonsat
temperaturesbeloworabove37-39°Cmayleadtosub-opmalprocedureoutcomes.
2. Soluonscanbepre-warmedinauidwarmerorawarmingchamber.
Alternately,aoneliterbagcanbepre-warmedinamicrowave–
approximately90secondsusingan800wamicrowave;
approximately72secondsusinga1000wamicrowave;
approximately60secondsusinga1200wamicrowave;
approximately48secondsusinga1500wamicrowave.
• Surgeonsshouldconfirmtheirowninstitutions’policiesonuseofmicrowavingpriortoproceedingwiththese
guidelines.
• TheyshouldalsoassurethatanymicrowavedLactatedRinger’ssolutionisinthe37°C-39°C(98.6-102.2°F)range
priortoinsertingitinREVOLVE
TM
System.
• Oncewarmed,keepthesolutionsinawarmertomaintain37°C-39°C(98.6-102.2°F)rangeuntilfillingcanister.
Ensureappropriatetemperaturepriortouse.
3. BeginthewashingphaseIMMEDIATELYaercompleonoftheharvestphase.Donotletthessuecoolinthe
canister.
GuidelinesforTissueHarvest:
1. Harvestatleast100mlofadiposewithinthemeshlter.Themaximumharvestis350mlofadiposewithinthemesh;do
notoverllthecanister,orthemeshltermayclog.
2. Harvest20%-30%moreadiposethanthedesiredortargetedamount.Thewashingphasereducesthevolumeofthe
adiposeasharvestedbywashingoutoils,intersaluids,trappeduidpockets,andcapturesandretainscollagenand
stringyssue.
Guidelines for Tissue Transfer:
1. Immediatelyextractthewashedadiposeintocatheterpsyringesaerwashingiscomplete.Iffatisthickordicult
toextractusingcatheterpsyringes,addasmallamountofwarmuidtothessue,sr,andthenextract.
2. Usecatheterpsyringesforssuetransferfromthedevice;Toomeysyringeswillnotwork.
Catheterpsyringesarelegally,commerciallyavailablefromallmajorsyringemanufacturers.Commonsizesare
30/35ml,50/60ml,and100/120ml.
Catheter Toomey
DeviceDescripon:REVOLVE
TM
Systemisasingleuse,sterile,disposablecanisterintendedforharvesng,ltering,and
transferringofautologousadiposessue.Thesystemshouldbeusedwithalegallymarketedvacuumoraspiratorapparatus
asasourceofsucon.Ifharvestedfatistobere-implanted,theharvestedfatisonlytobeusedwithoutanyaddional
manipulaon.
IndicaonsforUse:REVOLVE
TM
Systemisusedforaspiraon,harvesng,ltering,andtransferringofautologousadipose
ssueforaesthecbodycontouring.Thesystemshouldbeusedwithalegallymarketedvacuumoraspiratorapparatus
asasourceofsucon.Ifharvestedfatistobere-implanted,theharvestedfatisonlytobeusedwithoutanyaddional
manipulaon.
REVOLVE
TM
Systemisintendedforuseinthefollowingsurgicalspecialeswhentheaspiraonofsossueisdesired:plasc
andreconstrucvesurgery,gastrointesnalandaliatedorgansurgery,urologicalsurgery,generalsurgery,orthopedicsurgery,
gynecologicalsurgery,thoracicsurgery,andlaparoscopicsurgery.
Contraindicaons:Contraindicaonstoautologousfattransferincludethepresenceofanydiseaseprocessesthatadversely
aectwoundhealing,andpooroverallhealthstatusoftheindividual.
Warnings:
1. REVOLVE™Systemmustbeusedwithinthesamesurgicalprocedure.ReuseofREVOLVE™Systeminthesamepaentin
asubsequentsurgicalprocedure,orformorethanonepaent,mayresultininfeconand/ortransmissionof
communicablediseases.
2. Donotusetheproductifsterilepackagingisdamaged.
3. Thisdevicewillnot,inandofitself,producesignicantweightreducon.
4. Thisdeviceshouldbeusedwithextremecauoninpaentswithchronicmedicalcondionssuchasdiabetes,heart,lung,
orcirculatorysystemdiseaseorobesity.
5. Thevolumeofbloodlossandendogenousbodyuidlossmayadverselyaectintraand/orpostoperavehemodynamic
stabilityandpaentsafety.Thecapabilityofprovidingadequate,melyreplacementisessenalforpaentsafety.
Precauons:
1. Thisdeviceisdesignedtoremovelocalizeddepositsofexcessfatthroughsmallincisionandsubsequentlytransferthe
ssuebacktothepaent.
2. Useofthisdeviceislimitedtothosephysicianswho,bymeansofformalprofessionaltrainingorsanconed
connuingmedicaleducaon(includingsupervisedoperaveexperience),haveaainedprociencyinsucon
lipoplastyandssuetransfer.
3. Resultsofthisprocedurewillvarydependinguponpaentage,surgicalsite,andexperienceofthephysician.
4. Resultsofthisproceduremayormaynotbepermanent.
5. Theamountoffatremovedshouldbelimitedtothatnecessarytoachieveadesiredcosmeceect.
6. Fillingthedevicewithadiposessueoverthemaximumllvolumelinecanleadtoocclusionofthemeshresulngin
meshtear.
AdverseEects:
1. Somecommonadverseeectsassociatedwithautologousfattransferareasymmetry,over-and/orunder-correconofthe
treatmentsite,ssuelumps,bleeding,andscarring.
2. PotenaladverseeectsassociatedwithREVOLVE™Systemincludefatnecrosis,cystformaon,infecon,chronicforeign
bodyresponse,allergicreaconandinammaon.
Theexpiraondateprovidedonproductlabelsareinthefollowingformat:4digityear,2digitmonth,and2digitday
(YYYY-MM-DD).
Thisproduct,includingitspackagingandcomponents,isnotmadewithnaturalrubberlatex.
LifeCellCorporaon
OneMillenniumWay
Branchburg,NJ08876
1-800-433-8871
PatentedintheUS.Pleaseseewww.allergan.com/patents.AddionalpatentsmaybependingorissuedintheUSand
elsewhere.Allergan®anditsdesignaretrademarksofAllergan,Inc.REVOLVE™isatrademarkofLifeCellCorporaon,an
Allerganaliate.©2017Allergan.Allrightsreserved.
L00-7006RevG
/