working beyond the tube - zimmer biomet · 2020. 1. 11. · paraspinous approach to spinal surgery....

Surgical Technique

AccuVision® Minimally Invasive Spinal Exposure System

Working Beyond the Tube

• Lightedbladesforenhancedviewing

• Maximizedstabilization

B

Contents

Introduction .................................................Page1

FeaturesandBenefits ...................................Page2

Instruments .................................................Page3

SurgicalTechnique ......................................Page5

PosteriorFixationWith ................................Page12Polaris™5.5PedicleScrews

AccuVision®FrameRemovalandClosure ...Page18

IndicationsforUse .......................................Page19

SterilizationRecommendations ...................Page20

OrderingInformation ...................................Page21

FurtherInformation ......................................Page22

1

Introduction

BiometSpineisproudtopresenttheAccuVision®Minimally

InvasiveSpinalExposureSystem.TheAccuVision® System

hasbeendesignedtoofferavariableapproachtolumbar

fixationfortheever-growingMinimallyInvasiveapproach

tospinesurgery.TheAccuVision® Systemfeaturesa

Retractorframewithaseriesofblades,shimsandretractor

modulesthatprovideexceptionalexposuretothebony

anatomy,whileutilizingthewidelyacceptedModified-Wiltse,

ParaspinousapproachtoSpinalSurgery.

ThedesigngoalsfortheAccuVision® Systemweresimple;

provideafamiliarmodular,variableapproachtominimally

invasivespinesurgerywhilemaximizingtheexposureto

theanatomy.Theergonomicallydesignedframeallowsthe

surgeontoperformbothnon-fusionandfusionprocedures

withminimalchangetothesurgeon’sindividualtechnique.

2

Features and Benefits

Features Benefits

MinimalSkinIncision Lesstraumatomusculaturearoundthespine

MechanicalRetractionSystem Providesampleretractionuptofourdirections

Steerablemedial/lateralexposurewithoutchangingtable/frameattachments

Maximalexposurewithminimalincision

VariableBladeLengths Customfitsystembasedonpatientanatomy

StablePlatform Providesthesurgeonoptimizedworkspacewithout“fiddlefactor”orfloatingoftheframe inthesurgicalsite

3

Instruments

RetractorBlades

ShimAdvancer

ShimRetractor

RetractorWrench

RetractorFrame

RetractorArms

RetractorArms

4

Instruments (Continued)

DisposableBladeTips(LightedandNon-Lighted)

RadialSettingClamp

ArticulatingArm

Dilators

5

Surgical Technique

Patient Positioning and Pre-Operative Planning

Thepatientispositionedproneinthesurgeon-preferred

positionforaposteriorapproachtospinesurgery.

Utilizefluoroscopicimagingtoconfirmnecessary

visualizationofsurgicalsite.

Thepatientisthenpreparedanddrapedaccording

tosurgeonpreference.

Utilizinganterior/posteriorandlateralfluoroscopy

imagingandpalpationofthepatient’sappropriate

vertebrallandmarks,theincisionlineisidentified

2to4cmlateraltothemidlineasdirectedbythe

surgeonfortheindicatedsurgicalprocedure.

O.R. Tips

• Aspartofpre-operativeplanning,aspinalneedle orguidewirecanbeusedtoconfirmlocationand

trajectoryfortargetingthepedicleentrypoint

- Discectomy/Non-FusionProcedures:

• Thetargetareaistheloweraspectofthelamina overlyingdiscspacetobeaccessed

- FusionProcedures:

• Thetargetareaismidwaybetweenthecephalad andcaudalpedicleattheleveltobefused

• Toperformacontralateraldecompressionthrougha singlesidedapproach,thetargetareashouldbesimilar

totheapproachdescribedaboveforafusionprocedure

• Foratwo-leveldecompression,targetthemiddlevertebrae

- E.G.L3toL5laminectomy,targetoverthemiddleof L4vertebrae

6

Incision and Exposure

Accesstothebonyaspectoftheposteriorspinalanatomyis

initiatedwithaknifeincisionoftheskinatthesideandlevel

ofthespinerequiringexposurefortheprescribedprocedure.

Anincisionofthefasciaoverlyingthemusclegroupsisalso

performedtoassisttheexposureprocess.Thelengthofthe

skinincisionlinewillbedictatedbytheamountofanatomy

needingexposure.

O.R. Tips

• Theincisionshouldbefurtherlateraltothemid-line asthedistancebetweentheskinandposterior elementsincreases

NOTE:Thelengthofthefasciareleasecanextendbeyond

thelengthoftheskinincision.

Aftertheskinincisionandfasciareleasehavebeen

completed,sequentialdilationoftheopeningthrough

themusclesisperformed.

Surgical Technique (Continued)

Agentlesweepingofthefirstdilator(7.0mmdiameter)

shouldbeperformedtomobilizedeepsofttissueoff

thebonyanatomyandtoachieveanaccurateestimate

ofthetissuedepth.

Subsequentsequentialdilationcaneitherbeperformed

tothe18mm(yellow)dilatororthe25mm(blue)dilator

dependentuponsurgeonpreference.

O.R. Tips

• Followingthesequentialdilation,removethedilators andutilizeaCobbelevatortoscrapethesofttissue

offtheposteriorelementsandre-dilate

• Thecorrectbladelengthcanbedeterminedviathe followingmethod:

- Soundwiththefirstsequentialdilator(7.0mm diameter)intotheoperativesite,usingthedepth

markingstodeterminebladedepth.Ifthedepth isbetweentwomarkings,utilizetheshorterblade

7

Attachment of Blade Tips:

Selecttheappropriateshapedisposablebladeandlineup

thechannelsofthebladetothepostsofthereusableblade.

Slidetheshimretractordownthechanneloftheblade

andalignthe“T”intotheholeattheproximalendofthe

bladetip.Turnthehandleoftheshimretractor90°and

thespring-loadedinstrumentwillpullthebladeup.

Thebladeassemblycannowbeloadedintotheappropriate

partsoftheAccuVision® Frame.Thebladeisloadedby

aligningtheMale“T”attheproximalportionoftheblade

totheFemale“T”Slotontheappropriatebladearms.

Simplyslidethebladeintotheretainingfeatureofthe

armsuntilanaudible‘click’isheard.

NOTE:thecurvedportionofthebladeshouldalwaysbe

facingtowardsthecenteroftheframe.

Toremovethebladefromtheindividualarms,presson

thetaboftheretainingfeature,andpullthebladestraight

backfromthearm.

Articulating Arm Tips:

The AccuVision® Systemcomeswiththeoptionofattaching

lightedornon-lightedbladetipstotheindividualretractor

blades.Withthisinmind,pre-planyourretractionas

necessarytodeterminewherealightedblade(s)would

benecessarytoaidinthevisualizationoftheanatomy.

Light Source Information:

AccuVision® LightedBladeTipsaresterilepackedwitha

standardACMIAdapter.Asterilizedlightcableneedstobe

suppliedbytheO.R.toconnecttotheO.R.suppliedlight

source.DoNOTconnectthelightedbladetipdirectlyto

thelightsource.

8


Articulating Arm and AccuVision® Frame Configuration Assembly of Articulating Arm:

Determinewhetherthearticulatingarmswillbe

situatedoneitherthesurgeonsideortheassistantside.

Followingfacilityguidelinesforaseptictechnique,place

theradialsettingclampoverthesurgicaldrapestothetrack

alongthepreferredsideofthetable,andfixtothetrackby

turningthewingscrewsclockwiseuntiltight.

Turnthebluedoubleendedhandlecounterclockwiseuntil

thechannelisopenandguidethearticulatingarmthrough

theopeninguntilthedesiredheightofthearmisachieved

andturnthebluehandleclockwiseuntiltight.

O.R. Tip

• Formaximumstabilization,onearmwillbepositioned cephaladtotheoperativesiteandonearmwillbe

positionedcaudaltotheoperativesite.Spreading thetableattachmentswillallowroomforthesurgical assistantandlateralfluoroscopicvisualization

Positioneacharticulatingarminthegeneralareaofthe

operativesiteandprovisionallylockthearminplaceuntil

the AccuVision® Frameisplacedontothesurgicalfield.

Selectretractorbladesaccordingtothelengthdetermined

duringtheinitialdilationandassemblethemtothecephalad

andcaudalarmsoftheAccuVision® Frame.

WingScrew

9

Set-Up of the AccuVision® Frame on the Surgical Field

PlacetheAccuVision® Framewiththebladesattachedonto

thesurgicalfield.Positionthedeviceeithermedialorlateral

tothepatient’smidline.

Ensurethatthereisnoangulationordistractionofthe

retractorblades.Advancetheretractorbladesoverthe

sequentialdilatorsintotheincisionuntilthedistalends

ofthebladesrestonthebonyanatomyofthespine.

O.R. Tip

• Ifabi-lateralapproachisdesiredusingtwoAccuVision®

Framesatonce,theframe’slongitudinalaxisshould bepositionedlateralsothatthepatient’smidline isuncovered

Unlockthearticulatingarmbyturningtheblackstarhandle

counterclockwise,noteholdontothedistalportionofthe

armasthiswillreleasethetensiononthearticulatingarm.

Guidethequickconnectmechanismtothenearestcorner

postoftheAccuVision® Frame,alignproperlyandpush

downuntilanaudibleclickisheard.Turntheblackstar

handleclockwisefirmlytolockthearminplace.Repeat

fortheoppositeside.

O.R. Tip

• WhileattachingthearticulatingarmstotheAccuVision® Frame,holdfirmdownwardpressureontheframeasto notlosethetargetedpositionandtrajectoryofthesetup

Removethesequentialdilatorsfromthepatient.

O.R. Tip

• UseofA/Pandlateralfluoroscopicimagingtoconfirm placementofthedeviceontothebonyanatomy

ofthespineisrecommended

10

Toprovideadditionalmedialorlateralexposureofthe

operativesite,selecttheappropriatebladeandattach

ittothesupplementalretractormodule.Attachthemodule

totheappropriatedovetailconnectoronthearmofthe

AccuVision® Frame.


Intra-Operative Repositioning of the AccuVision® Frame

and Addition of Supplemental Retractor Blades

Toextendtheexposureofthespinelongitudinallywithin

theoperativesite,usetheprovidedhexwrenchtoturn

theratchetcontrolpointonthelongsideoftheAccuVision®

Frametoretractthecephaladandcaudalretractorblades.

Toanglethedistalendofaretractorbladeout,usethehex

wrenchandturnthesetscrewonthearmattachedtothat

bladeinaclockwiserotation.

11

Independentarticulationofthelateralretractormoduleand

angulationoftheretractorbladeisachievedbyusingthehex

wrenchandturningthesetscrewforthedesiredmotion

inthecorrectrotation.

NOTE:Theprimaryretractormodulesrequirecounter

clockwiserotation.

Whilethealternate(etchedas“A”)retractormodulerequire

clockwiserotation.

Utilizationoftheprimaryoralternatelateralretractors

isbasedonsurgeonpreference.

Intraoperativemedial/lateralangulationoftheentire

AccuVision® Frameisachievedbyusingthehexwrenchto

adjustthesetscrewonthesideoftheframe.Thisangulation

will“air-plane”theentireinnerportionoftheframetoallow

foradditionalmedialorlateralexposure.

ViewofanatomywithAccuVision® Frameinplace.

12

Posterior Fixation with Polaris™ 5.5 Pedicle Screws

Pedicle Preparation

Afteradequateexposureisachieved,theappropriatepedicle

entrypointisselectedandtheentrancetothepedicleis

openedwithanawl,burr,orcurette.Theappropriatediameter

ReamerProbeisusedtopreparethepedicleusingaslow

circularmotion,allowingtheReamerProbetocenteritself

alongthelongitudinalaxisofthepedicle.EachReamerProbe

ismarkedwiththemajordiameterofthescrewwithwhich

itistobeused.TheReamerProbeisinitiallyadvancedtoa

depthofapproximately30mmusingthedepthmarkings

asaguide.

InsteadofaReamerProbe,aPedicleProbemaybeutilized.

ThePedicleProbeisusedtocreatethepedicleholeby

advancingtheProbetoadepthofapproximately30-40mm

usingthedepthmarkingsasaguide.ThePedicleSoundis

thenusedtoconfirmbonycontainmentofthepediclehole

bypalpatingallfourwallsaswellasthebottomofthehole

throughthepedicleandintothevertebralbody.

Althoughthescrewsareself-tapping,Tapsareavailablewith

theSystemandmaybeutilizedtopreparethepediclehole.

SelectthecorrespondingTapforthechosenscrewdiameter

andadvancetheTapintothepedicleholeusingtheQuick

ConnectHandle.

TheTrialPinsmaybeutilizedtoconfirmproperorientation

andtrajectory.

OpentheentrancetothepediclewiththePedicleAwl

PreparethepedicleholewiththeReamerProbe

PreparethepedicleholewiththechosenTap

ConfirmcontainmentofthepediclewiththePedicleSound

UsetheTrialPinstoensureproperorientationandtrajectory

13

Screw Selection and Insertion

Self-tappingscrewsareavailableinseveraldiametersand

lengths.Theappropriatescrewlengthisdeterminedbyusing

thedepthmarkingsonthePedicleProbeorReamerProbe.

TheMulti-axialScrewsmaybeloadedfreehandorwhile

seatedwithinthesurgicaltray.AttachtheMulti-axialScrew

DrivertotheQuickConnectHandlebypullingbackon

theplungeratthebaseofthequickconnectmechanism,

insertingtheshaft,andreleasingtheplungertolocktheshaft

inplace.Holdthescrewbythescrewshaftandloadthescrew

ontothetipoftheMulti-axialScrewDriver.Ensurethatthe

malepentalobeatthedistaltipoftheMulti-axialDriveris

fullyseatedwithinthefemalepentalobelocatedatthetopof

thescrewshaft.Turntheknurled-Tinaclockwisedirection

tothreadtheoutershaftintotheseat.Confirmthatthescrew

isstraightandsecureintheDriver.Thescrewisadvanced

intothepedicletothedesireddepth.Duringinsertion,guide

theDriverbyholdingthebluesleeveontheshaftofthe

instrument.TheDriverisdisengagedfromthescrewby

rotatingtheknurled-Tinacounterclockwisedirectionand

thenliftingtheDriverfromthescrew.

NOTE:TheMulti-axialScrewmustnotbedrivenintothe

pedicleholesotightlythatvariableangulationoftheseat

isprevented.

Selecttheappropriatescrewsize

LoadthescrewontoMulti-axialScrewDriver

TurntheknurledTatthetopoftheDrivertothreadtheouter

shaftintotheseat

Insertthescrewintothepedicle

14

InsertrodusingtheRodHolder

SetthedialontheRodBendertoachievethe

desiredcurvature

Posterior Fixation with Polaris™ 5.5 Pedicle Screws (Continued)

Rod Application

Onceallscrewshavebeeninserted,theappropriatelength

rodshouldbechosenaccordingtotheconstruct.TheRod

Templatemaybeusedtoaidinrodselection.Therodshould

projectatleast2.0mmbeyondthescrewseatsattheend

oftheconstruct.Besuretoaccountforlargecurvesand

distractionswhenchoosingrodlength.Ifnecessary,

theselectedrodmaybecontouredwiththeRodBender.

MeasurelengthoftherodusingtheRodTemplate

Selectappropriatelengthrod

15

ThePersuadermaybeusedtofullyseattherodinthe

screwseat

Helical Flange® Plug Application

Whenallscrewshavebeeninsertedandtherodshavebeen

placedinthescrewseats,theconstructisthensecured

usingHelicalFlange® Plugs.Oneplugisfirmlypressedonto

eachendoftheDoubleEndPlugStarter.Allplugsshouldbe

placedandthenprovisionallytightened.

Ifnecessary,thePlugStartermaybeusedincombination

withtheRodPersuader,ReductionFork,orRodPusher.

WhenusingtheRodPersuader,placethePersuaderover

thetopofthescrewseat.TheinternalstopofthePersuader

willensuretheinstrumentisinthecorrectpositiononthe

seattofacilitatemanipulation.Squeezethehandleofthe

RodPersuadertofullyseattherodinthescrewseat.

ThePlugStarterwillfitthroughthecannulatedportionof

thePersuader,allowingforplugapplicationwiththeRod

Persuaderinplace.ToreleasethePersuader,pressthe

triggerlocatedunderneaththehandle.Oncereleased,

thePersuadermaythenberemovedfromthescrewseat.

LoadplugontotheDoubleEndPlugStarter

Insertplug

16

Posterior Fixation with Polaris™ 5.5 Pedicle Screws (Continued)

Helical Flange® Plug Application (Continued)

WhenusingtheReductionFork,positiontheforksection

underneathscrewseat.TilttheReductionForktopersuade

therodintothescrewseat.

WhenusingtheRodPusher,placethedistaltipontothe

rodandpushtheroddowntopersuadetherodintothe

screwseat.

TheTorqueStabilizermaybeusedtorepositiontheaxisof

thescrewseatwhilesimultaneouslyactingasaguidefor

thePlugStarter.

NOTE:Ifsofttissueisinterferingwithproperplugplacement,

theSoftTissueRetractormaybeutilizedtoretractthesoft

tissueawayfromthescrewbyplacingthebifidtipofthe

retractorunderthescrewseat.

ReductionFork

Pushtheroddowntopersuaderodintotheseatandinsert

theplug

TorqueStabilizermaybeusedtoguidethePlugStarter

TheSoftTissueRetractoraidsretractionofthesofttissue

awayfromthescrewseat

17

ArrowsoftheTorqueIndicatingWrenchlineupat0,

signifyingthestartposition.Whenthetorquelevelis

achieved,thearrowwilllineupat110in-lbs.

THEREISNOAUDIBLECLICK

TurntheTorqueLimitingWrenchclockwiseuntilanaudible

clickisheardat110in-lbsoftorque

NOTE:Usethechosentorqueinstrumentincombinationwith

theTorqueStabilizer.

Final Locking

Afterprovisionaltightening,properimplantplacement

shouldbeconfirmedwithradiographs.Theplugsarethen

tightenedwitheithertheTorqueIndicatingWrenchorthe

TorqueLimitingWrenchincombinationwiththeTorque

Stabilizer.Insertthechosentorquingdevicethroughthe

centeroftheTorqueStabilizer.PositionthetipoftheTorque

Wrenchintotheplug.SeatthedistalendoftheTorque

StabilizeroverthescrewseatandconfirmthattheStabilizer

fitsfirmlyontherod.Therodwillbepositionedwithinthe

slotsoftheStabilizer.

TheTorqueIndicatingWrenchisturnedinaclockwise

directionwhiletheTorqueStabilizerisheldwithresistive

forceinacounterclockwisedirection.Twoetchedarrows

indicatewhentheappropriatetorqueisobtained.Thefirst

setofarrowslineupshowingthestartpositionatzero.

Uponreachingtheintendedfinaltorque,twoarrowswill

lineupat110in-lbs.

THEREISNOAUDIBLECLICKwiththeTorqueIndicating

Wrench.OvertorquingwiththeTorqueIndicatingWrench

(turningbeyondthepointwherethearrowslineup)may

damagethewrench.Alwaysensurethewrenchindicates

0in-lbs.oftorquepriortouse.

TheTorqueLimitingHandleattachestothePlugDriver.

TheTorqueLimitingWrenchisturnedinaclockwise

directionwhiletheTorqueStabilizerisheldwithresistive

forceinacounterclockwisedirection.TheTorqueLimiting

Wrenchshouldbeturneduntilanaudibleclickisheard,

applying110in-lbsoftorque.

18

AccuVision® Frame Removal and Closure

Aftercompletionoftheselectedspineprocedure(s)

utilizingtheAccuVision® System,firstreducethedistraction

andangulationfromanyauxiliarybladesandremoveall

lateralretractormodules.

Reducedistractionofthecephaladandcaudalbladesby

engagingthereleasemechanismandusingthehexwrench

toturntheratchetcontrolscrew.

Oncealldistractionandangulationisadequatelyreduced,

removetheframeandarticulatingarmsfromthesurgicalfield.

Closureoftheoperativesiteisperformedinlayersaccording

tostandardprotocolsandfacilityguidelines.

NOTE:EnsurethatallAccuVision® componentshavebeen

removedviavisualcheckpriortoclosure.

19

Indications for Use

Indications for Use

The AccuVision® MinimallyInvasiveSpinalExposureSystem, whenusedwiththePolaris™5.5SpinalSystemimplants areindicatedtoprovidethesurgeonwithaminimallyinvasiveapproachforposteriorspinalsurgeryforthefollowingindications:degenerativediscdisease(definedasdiscogenicbackpainwithdegenerationofthediscconfirmedbyhistoryandradiographicstudies),spondylolisthesis,trauma,(i.e.,fractureordislocation),deformityorcurvature(i.e.,scoliosis,kyphosisandlordosis),tumor,stenosis,pseudoarthrosisandfailedpreviousfusionthatwarranttheuseofanon-cervicalspinalfixationdeviceintendedfortheuseasapediclescrewfixationsystemorsacral/iliacscrewfixationsystem.Pediclescrewfixationislimitedtoskeletallymaturepatientsandforusewithautograft.

TheAccuVision®IlluminatedBladeTipisasterile,singleuse,latexfree,plasticfiberopticdeviceintendedtobringcoolarealightingintospinalsurgeries.TheAccuVision® IlluminatedBladeTipisintendedforusewitha300wattxenonilluminator,usinga3.0mmfiberopticcablewithafemaleACMIconnector.

Contraindications

The AccuVision® MinimallyInvasiveSpinalExposureSystemiscontraindicatedinpatientswithspinalinfectionorinflammation,morbidobesity,mentalillness,alcoholismordrugabuse,pregnancy,mentalsensitivity/foreignbodysensitivity,patientswithinadequatetissuecoverageovertheoperativesiteoropenwoundslocaltotheoperativearea,oranycasenotdescribedinthespecificindications.

Seethepackageinsertforadditionalwarnings,precautions,adverseeventsandotherproductinformation.

TheAccuVision®BladeTipspresentnoadditionalcontraindications.Theusershouldbefamiliarwith theuseoflightsourcesandcablesandshouldtakeprecautionsaccordingly.

Warnings

Thesafetyandeffectivenessofpediclescrewspinalsystemshavebeenestablishedonlyforspinalconditionswithsignificantmechanicalinstabilityordeformityrequiringfusionwithinstrumentation.Theseconditionswithsignificantmechanicalinstabilityordeformityofthethoracic,lumbar,andsacralspinesecondarytosevereSpondylolisthesis(grades3and4)oftheL5-S1vertebra,degenerativespondylolisthesiswithobjectiveevidenceofneurologicimpairment,fracture,dislocation,scoliosis,kyphosis,spinaltumor,andpreviousfailedfusion(pseudoarthrosis).The

safetyandeffectivenessofthesedevicesforanyotherconditionsareunknown.

Potentialrisksidentifiedwiththeuseofthedevicewhichmayrequireadditionalsurgery,includedevicecomponentfailure,lossoffixation,non-union,fractureofthevertebra,neurologicalinjury,andvascularorvisceralinjury.Seepackageinsertforadditionalinformation.

Light Source.TheAccuVision®IlluminatedBladeTipisdesignedforusewith300wattxenonilluminators,usinga3.0mmfiberopticcable.Donotuselightsourcesratedhigherthan300watts,orcableswithfiberopticbundlesofmorethan3.0mmdiameter.Useofhigherwattsourcesorlargerdiametercablescouldresultinoverheating;causingproductfailureandpatientinjury.Shouldthebladeassemblybecomecut,collectfluidinside,appearbrokenordamagedinanymanner,itshouldbereplacedtominimizerisktothepatient.

WhenusedwiththeAccuVision®Instruments,useislimitedtotheimplantationofrodlengthsof100mmorless,andexcludestheuseofsystemcrossconnectorsorhooks.

Precaution

Illuminated Blades.Lightsourcesvarywidelyinemissionofvisibleandinfraredenergy.Asaprecautionarymeasure,whenusingAccuVision®IlluminatedBladeTipswerecommendoccasionallymonitoringconnectortemperatureduringfirsttimeusewithanewlightsourceorlamp;thereafterifneeded.Asiscommonwithfiberopticequipment,metalportionofconnectorcanbecomehottothetouch.Useplasticgripashandle.Donotplacethemetalringportionofconnectordirectlyonthepatient’sskin.Afteruse,theAccuVision®BladeTipsmaybeapotentialbiohazard.Handleanddisposeofinaccordancewithacceptedmedicalpracticeandapplicablelocal,stateandfederallawsandregulations.

TheAccuVision®IlluminatedBladeTipshouldbeusedinaccordancewithallinstructionsfortheAccuVision®retractorframe.TheAccuVision®IlluminatedBladeTipconnectstoalightsourceusedforheadlampsorendoscopes.A3.0mmfiberopticcablewithanACMIfittingattachesthelightsourceandAccuVision®IlluminatedBladeTip.MakesuretheLightedBladeconnectorissecurelyattachedtothecable.Thecableshouldbeingoodrepairwithcleanoptics.Dirtyopticsorcablesinneedofrepaircancauseexcessiveheatattheconnectors.

Turningdownoverheadlightingmayimprovevisualizationwithinthesurgicalsite.

20

Sterilization Recommendations

The AccuVision® MinimallyInvasiveSpinalExposure

Systemisprovidednonsterileandmustbesterilizedprior

touse.Allpackagingmaterialsmustberemovedpriorto

sterilization.Thefollowingsteamsterilizationparameters

arerecommended.

Cycle: HighVacuum

Temperature: 270°F(132°C)

Time: 8Minutes

DryingTime: 20Minutes

21

Ordering Information

AccuVision® Disposable Blade Tip Case

(Catalog # 14-509625)

Catalog # Description Qty/Tray

14-500550 BladeTip1/3-18mmDia. 4



14-500555 IlluminatedBladeTip1/3-18mmDia. 2



AccuVision® Blade Mount Case

(Catalog # 14-509622)


14-500504 18mmBlade40mmLong 3








14-500514 FlatBlade40mmLong 2
















AccuVision® Access Arm Case

(Catalog # 14-509621)


2000-6455 AccuVision® ArticulatingArm 2

2000-6452 AccuVision® RadialSettingClamp 2

AccuVision® Retractor Frame Case

(Catalog # 14-509620)


2000-6510 AccuVision® RetractorFrame-Small 1

2000-6512 AccuVision® LateralRetractorModuleA 2

2000-6513 AccuVision® LateralRetractor 2

2000-6506 RetractorWrench 2

14-500545 ShimAdvancer 1

14-500546 ShimRetractor 1

2000-6405 25mmDilationTube-Blue 1

2000-6404 22mmDilationTube 1

2000-6403 18mmDilationTube-Yellow 1

2000-6402 12mmDilationTube 1

2000-6401 7.0mmDilationTube 1

94152 2.8mmTrocarSteinmannPin 1

22

Further Information

The Polaris™5.5SpinalSystem iscoveredbynumerous

U.S.andInternationalpatents.U.S.Patentnumbers:

5,360,431;5,466,237;5,474,555andPatentsPending.

HelicalFlange®isaregisteredtrademarkofRogerP.Jackson.

CAUTION:FederalLaw(USA)restrictsthisdevicetosale

byorontheorderofaphysician.

ThisbrochuredescribesasurgicaltechniqueusedbyDan

S.Cohen,M.D.Thesurgeonwhoperformsanyimplant

procedureisresponsiblefordeterminingtheappropriate

products(s)andutilizingtechnique(s)forineachindividual

patient.Thecontentsofthismanualareintendedtobeonly

aguideandarenotintendedtosetastandardofcare.

Forfurtherinformation,pleasecontacttheCustomerService

Departmentat:

BiometSpine

399JeffersonRoad

Parsippany,NJ07054

973.299.9300•800.526.2579

www.biometspine.com

23

Notes:

24

Notes:

AtBiomet,engineeringexcellenceisourheritageand

ourpassion.Forover25years,throughvarious

divisionsworldwide,wehaveappliedthemost

advancedengineeringandmanufacturingtechnology

tothedevelopmentofhighlydurablesystemsfora

widevarietyofsurgicalapplications.

Tolearnmoreaboutthisproduct,

contactyourlocalBiometSalesRepresentativetoday.

AccuVision® Minimally Invasive Spinal Exposure SystemWorking Beyond the Tube

Parsippany,NJ•800.526.2579www.biometspine.com•BSP216532L03/10

©2010EBI,LLC.AlltrademarksarethepropertyofBiomet,Inc.oroneofitssubsidiariesunlessotherwiseindicated. U.S.PatentNo.5,360,431;5,466,237;5,474,555;andPatentsPending.HelicalFlange®isaregisteredtrademarkofRogerP.Jackson.RxOnly.

working beyond the tube - zimmer biomet · 2020. 1. 11. · paraspinous approach to spinal surgery....

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