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.

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. 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

transferringofautologousadiposessue.Thesystemshouldbeusedwithalegallymarketedvacuumoraspiratorapparatus

manipulaon.

REVOLVE

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

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.

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