plasmax gpsiii brch

BIOLOGICS

Plasmax® Plasma Concentration

System

Plasmax® Plasma Concentrate System Contains •Plasmax® concentrator

•GPS® III separator

Provides •16mlofautologousoutput,6mlofPRPand10mlofautologousplasmaconcentrate

•Rapidlypolymerizingautologousplasmaconcentrate

•GPS®IIIgeneratedPRPhasninetimesmoreplateletsand5timesmorewhitebloodcells

thenwholeblood1

Consistent/ReproducibleResults •UtilizesGPS®IIItechnologytoproduceplateletrichplasma

•Polyacrylamidebeadsremoveexcesswaterfromplasmaintwominutes

Safe •Autologousendproducts

•Eliminatesconcernsregardingpooledbloodsources

Plasmax® Plasma Concentration System

Plasmax®

Concentration System (800-0516)

Plasmax® Plus Concentration

System (800-0517)WholeBlood

Input30ml 60ml

PlateletRich PlasmaOutput

3ml 6ml

Platelet Poor PlasmaInput

15ml 25ml

Plasma Concentrate Output

6ml 10ml

Note:Refertopackageinsertsformoredetaileddescriptions

Step One: Load

Remove discard cap and green packaging post

on center port (No 1). Slowly load blood-filled

60ml syringe (5ml of citrate anticoagulant and

55ml of blood) into the center port (No 1) of the

GPS®IIIseparator.

Remove and discard protective cover on tethered

whitecap.Screwwhitecapontocenterport(No1).

PlaceGPS®IIIseparatorintocentrifuge.Filltheblue

GPS® III counterbalance (800-0508) with 60–65ml

ofsterilesalineandplace into theoppositesideof

thecentrifuge.

Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) Preparation with GPS® III SystemTechniquedescribesPlasmax®PlusConcentrationSystem(800-0517)

StepTwo:Spin

StepThree:PPPandPRPExtraction

Closethelidandsetspeedfor3200RPMandtimer

to15minutes.Pressgreenbuttontostartspin.

Once spin is complete, remove yellow cap (No 2).

Invert the tube and withdraw 25ml of PPP (No. 2)

withasterile30mlsyringe.Replaceyellowcap.

Remove red cap on side port No. 3 and connect

sterile10mlsyringe.Withdraw2ml.


StepThree:PPPandPRPExtraction(Continued)

With 10ml syringe attached, suspend the platelets

bygentlyshakingthetubefor30seconds.

Extracttheremainingplateletrichplasma(PRP)into

theattached10mlsyringe.


Spinpaddlebyhanduntilplasmaisfullymixedinto

beads.Mixingiscompletewhenthewhitebeadsare

completelysaturatedwithplasma.

Note: While spinning, piston the paddle, be sure

to push it firmly against the bottom to ensure

adequatemixing.

Platelet Poor Plasma (PPP) Concentration with Plasmax® Concentrator

StepFour:LoadPlasma

UnscrewyellowcaponportNo.1ofPlasmax®Plus

concentrator and fill with 25ml of PPP. Replace

cap (800–0517). Remove and discard protective

coverontetheredwhitecap.Screwwhitecaponto

portNo1.

TechniquedescribesPlasmax®PlusConcentrationSystem(800-0517)

StepFive:Spin

Place Plasmax® Plus (800–0517) concentrator

into centrifuge with the empty Plasmax® Plus

counterbalance(800–0512).Theyshouldbeplaced

on opposite sides in the centrifuge. Spin for 2

minutesat2000RPM.

StepSix:ExtractionofPlasmax®

After the spin, the Plasmax® Plus concentrator

containsapproximately10mlofautologousplasma

concentrate.

UnscrewredcaponportNo.2.Connectsterile10ml

syringe on port No. 2 and extract approximately

10mlofconcentratedplasma.

Platelet Poor Plasma (PPP) Concentration with Plasmax® ConcentratorTechniquedescribesPlasmax®PlusConcentrationSystem(800-0517)

Ordering Information

Part No. Description800-0516 Plasmax® Plasma Concentrate Kit800-0517 Plasmax®PlusPlasmaConcentrateKit755VES Centrifuge115volt50–60Hz(TableTop)

800-0508 GPS®Counterbalance(Blue)800-0512 Plasmax®PlusConcentratorCounterbalance800-0510 Plasmax®ConcentratorCounterbalance800-0250 SprayApplicatorKit(Tipnotincluded)800-0201 DualSprayApplicatorTip800-0202 MalleableDualCannulaTip20Gaugex4”Length800-0203 MalleableDualCannulaTip20Gaugex7”Length800-0206 MalleableDualCannulaTip20Gaugex10”Length800-0204 BlendingConnectorTipSingleCannula800-0260 AerosolSprayKitwithTip800-0211 AerosolRegulatorw/ovent800–0215 EndoscopicAerosolVentingRegulator800–0208 RigidDualCannulaAerosolTip5mmdia.x16”Length(TubingIncluded)800–0216 RigidDualCannulaTip5mmdiax12”Length800-0207 MalleableDualLumenEndoscopicTip5mmdia.x12”Length

QualityPlateletConcentrate • Fromasmallvolumeofapatient’sblood,theGPS® III System providesahighqualityplateletconcentrateinanefficientmanor.

EaseofUse •Loadblood,spin,extractplateletconcentrate.

•Kitscontainallcomponentsneededtoprocessplatelet concentrate—nosearchingforindividualitems.

Safety •Patient’sownbloodisused.

•Bloodtakenatpoint-of-care.

•Smallvolumeofbloodrequired(27–110ml).

GPS® III Platelet Concentrate

Theinformationcontainedinthispackageinsertwascurrentonthedatethisbrochurewasprinted.However,thepackageinsertmayhavebeenrevisedafterthatdate.Toobtainacurrentpackageinsert,pleasecontactBiometatthecontactinformationprovidedherein.

Biomet Biologics, Inc. 01-50-1448 P.O.Box587 Date:03/0756E.BellDriveWarsaw,Indiana46581USA

Plasmax™ Plasma Concentrator Accessory used with GPS® III Mini Platelet Concentrate Separation Kit with ACD-A

ATTENTION OPERATING SURGEON

NOTE: FOR SINGLE USE ONLY. Discard the entire disposable kit after one use, using acceptable disposal method for potentially contaminated blood products. DESCRIPTIONS Plasmax™ Plasma Concentrator Accessory The Plasmax™PlasmaConcentratorAccessoryaids in theconcentrationof thepatient’sownplasmaproteinsbycentrifugationutilizingaBiometBiologicscentrifuge.Excesswaterisremovedfromtheplatelet-poor-plasma(PPP)withdesaltingbeads. GPS® III Mini Platelet Concentrate Separation Kit with ACD-A TheGPS®IIIMiniPlateletConcentrateSeparationKitwithACD-Aaidsseparationofthepatient’sownbloodcomponentsbydensitythroughtheuseofaBiometBiologicscentrifuge. MATERIALS ThePlasmax™PlasmaConcentratorAccessoryconsistsofmedicalgradepolymerssuitablefortheuseinmedicaldevices,andcontainsporouspolyacrylamidedesaltingbeads. TheGPS® IIIMiniPlateletSeparationKitwithACD-A includes syringes, needles, tubing, con-nectors,andplateletseparatorswhichalsoconsistofmedicalgradepolymers,elastomersandstainlesssteelssuitableforuseinmedicaldevices. Blood-draw components in this kit are packaged, labeled and sterilized as indicated by themanufacturer’slabeling. Allcomponentsinthiskitarelatex-free. ACD-A is an anticoagulant supplied by Citra Anticoagulants, Inc., Braintree, MA, and manu-facturedbyCytosolLaboratories, Inc.,Braintree,MA.Forfurther informationregardingACD-A,pleasecontactthesupplierat1-800-299-3411. TheACD-AincludedinthiskitisonlyforusewiththePlasmax™PlasmaConcentratorAccessoryusedwithGPS®IIIMiniPlateletConcentrateSeparationKit. INDICATIONS ThePlasmax™PlasmaConcentratorwithGPS®IIIMiniPlateletConcentrateSeparationKitwithACD-Aisdesignedtobeusedforthesafeandrapidpreparationofconcentratedplatelet-poor-plasma(PPPc)andautologousplatelet-rich-plasma(PRP)fromasmallsampleofbloodatthepatient’spointofcare.ThePPPcandPRPcanbemixedwithautograftandallograftbonepriortoapplicationtoanorthopedicsurgicalsiteasdeemednecessarybytheclinicaluserequirements. CONTRAINDICATIONS 1. Useasadialyzerorfordialysiswithadialysate. 2. Directconnectiontopatient’svascularsystemofcirculatingbloodvolume. WARNINGS AND PRECAUTIONS 1.Usepropersafetyprecautionstoguardagainstneedlesticks. 2.Followmanufacturerinstructionswhenusingthecentrifuge.UseonlyBiometBiologicscen-

trifuges(GPS®–IECcentrifugeorDruckerCompanycentrifuge).Outcomesusingcentrifugesfromothermanufacturersareunknown.

3.Donotusesterilecomponentsofthiskitifpackageisopenedordamaged. 4.Singleusedevice.Donotreuse. 5.Thesurgeonistobethoroughlyfamiliarwiththeequipmentandthesurgicalprocedureprior

tousingthisdevice. 6. Thepatientistobemadeawareofthegeneralrisksassociatedwithtreatmentandpossible

adverseeffects. 7.UsepreparedPPPcandPRPwithin4hoursafterdrawingbloodfrompatient,accordingto

currentAABBguidelines. 8.Thesafetyandeffectivenessforbonehealingandhemostasishavenotbeenestablished. POSSIBLE ADVERSE EFFECTS 1.Damagetobloodvessels,hematoma,delayedwoundhealingand/orinfection. 2.Temporaryorpermanentnervedamagethatmayresultinpainornumbness. 3.Earlyorlatepostoperativeinfection. STERILITY ThePlasmax™PlasmaConcentratorAccessoryandtheGPS®IIIMiniPlateletSeparatoraresteril-izedbyexposuretoaminimumdoseof25kGygammaradiation.Allothercomponentssuppliedinthiskitaresterilizedbytherespectivesuppliersusingradiationorethyleneoxidegas(ETO).Donotre-sterilize.Donotuseafterexpirationdate. INSTRUCTIONS FOR USE NOTE: Use standard aseptic technique throughout the following procedures. PROCEDURE ONE:Use theGPS® IIIMiniPlateletConcentrateSeparationKitwithACD-A toprepareplatelet-poor-plasma(PPP)andPRP. 1.DRAW:Draw3mlofACD-A into30mlsyringe.Attach to18-gaugeapheresisneedleand

primewithACD-A.Slowlydraw27mlofpatient’sownblood intothe30mlsyringeprimedwith ACD-A. Gently, but thoroughly, mix the whole blood and ACD-A upon collection topreventcoagulation.

2.LOAD: ENSURE BLOOD FROM ONLY ONE PATIENT IS PROCESSED PER SPIN,and that the platelet separator remains upright.Unscrewclearcaponcenterbloodport#1.Removeanddiscardcapandgreenpackagingpost.Slowlyloadblood-filled30ml

syringe(3mlofACD-Amixedwith27mlofpatient’swholeblood)intocenterbloodport#1.Unscrewanddiscardclearprotectiveinnerpiecefromwhitecaptetheredtoport#1.Screwwhitecapontoport#1.PlaceplateletseparatorfilledwithanticoagulatedbloodinaBiometBiologicscentrifuge.

3.BALANCE:FillpurpleGPS®Minicounterbalancetube(800-0505)with30mlofsterilesaline/water(equaltotheamountofwholebloodplusACD-Adispensedintheplateletseparator).Placefilledcounterbalancedirectlyoppositefromtheplateletseparatorinthecentrifuge.

4.SPIN:Closecentrifugelid.SetRPMto3.2(x1,000)andthetimeto15minutes.Pressthestartbutton.Oncespiniscomplete,opencentrifuge.

5.EXTRACT PPP:Unscrewyellowcaponport#2,andsaveyellowcap.Connect30mlsyringetoport#2,invertplateletseparator,andextractexactly15mlofPPP.Remove30mlsyringefromport#2,capwithasterilesyringecap,andsetaside.Replaceyellowcaponport#2.

6.If PRP is desired, follow steps 7 – 8. 7.SUSPEND PRP:Holdingplateletseparatorintheuprightposition,unscrewredcaponport

#3.Attacha10mlsyringetoport#3.Extract1mlofPRPinthe10mlsyringe.Leavethe10mlsyringeattachedtoport#3.Shakeplateletseparatorgentlyfor30seconds.

8.EXTRACT PRP:Immediatelyaftersuspendingtheplatelets,extractremainingPRPintotheattached10mlsyringe.Remove10mlsyringe fromport#3,andcapwithasterilesyringecap.

PROCEDURE TWO:UsethePlasmax™PlasmaConcentratorAccessorytopreparePPPc. 1.LOAD:Unscrewcaponport#1.Slowly loadthe15mlPPPcollected in30mlsyringe into

port#1.Unscrewanddiscardclear,protectiveinnerpiecefromwhitecaptetheredtoport#1.Screwwhitecapontoport#1.

2.MIX: Twist and piston the mixing paddle for 30 seconds. Be sure to push and twist thepaddle to thefloorof the Plasmax™PlasmaConcentratorAccessory’supperchamber tosaturatethebeads.Thereshouldbenowhitebeadsvisible.Placeintocentrifuge.

3.BALANCE:PlacethegreenPlasmax™counterbalance(800-0510)directlyoppositefromthePlasmax™PlasmaConcentratorAccessoryinthecentrifuge.

4.SPIN:ClosecentrifugelidandsetRPMto2.0(x1,000)andthetimeto2minutes.Pressthestartbutton.Oncespiniscomplete,opencentrifuge.

5.EXTRACT PPPc:Unscrewredcaponport#2andextractPPPcusingasterile10mlsyringe.Remove10mlsyringefromport#2,andcapwithasterilesyringecap.

Caution:Federallaw(USA)limitsthisdevicetosaleorusebyorontheorderofaphysician.

CommentsregardingthisdevicecanbedirectedtoAttn:RegulatoryDept.,Biomet,P.O.Box587,Warsaw,IN46581USA,FAX:574-372-1683. GPSisaregisteredtrademarkofBiometManufacturingCorp.intheUnitedStates.

Theinformationcontainedinthispackageinsertwascurrentonthedatethisbrochurewasprinted.However,thepackageinsertmayhavebeenrevisedafterthatdate.Toobtainacurrentpackageinsert,pleasecontactBiometatthecontactinformationprovidedherein.

Biomet Biologics, Inc. 01-50-1456 P.O.Box587 Date:03/0756E.BellDriveWarsaw,Indiana46581USA

Plasmax™ Plus Plasma Concentrator Accessory used with GPS® III Platelet Concentrate Separation Kit with ACD-A

ATTENTION OPERATING SURGEON

NOTE: FOR SINGLE USE ONLY. Discard the entire disposable kit after one use, using acceptable disposal method for potentially contaminated blood products. DESCRIPTION Plasmax™ Plus Plasma Concentrator Accessory The Plasmax™ Plus Plasma Concentrator Accessory aids in the concentration of the patient’sownplasmaproteinsbycentrifugation,utilizingaBiometBiologicscentrifuge.Excesswater isremovedfromtheplatelet-poor-plasma(PPP)whenmixedwithdesaltingbeads. GPS® III Platelet Concentrate Separation Kit with ACD-A TheGPS®IIIPlateletConcentrateSeparationKitwithACD-Aaidsseparationofthepatient’sownbloodcomponentsbydensitythroughtheuseofaBiometBiologicscentrifuge. MATERIALS ThePlasmax™PlusPlasmaConcentratorAccessoryconsistsofmedicalgradepolymerssuitablefortheuseinmedicaldevices,andcontainsporouspolyacrylamidedesaltingbeads. TheGPS®IIIPlateletConcentrateSeparationKitwithACD-Aincludessyringes,needles,tubing,connectors,andplateletseparatorswhichconsistofmedicalgradepolymers,elastomersandstainlesssteelssuitableforuseinmedicaldevices. Blood-draw components in this kit are packaged, labeled and sterilized as indicated by themanufacturer’slabeling. Allcomponentsinthiskitarelatex-free. ACD-A is an anticoagulant supplied by Citra Anticoagulants, Inc., Braintree, MA, and manu-facturedbyCytosolLaboratories, Inc.,Braintree,MA.Forfurther informationregardingACD-A,pleasecontactthesupplierat1-800-299-3411. The ACD-A included in this kit is only for use with the Plasmax™ Plus Plasma ConcentratorAccessoryusedwithGPS®IIIPlateletConcentrateSeparationKit. INDICATIONS The Plasmax™ Plus Plasma Concentrator Accessory used with GPS® III Platelet Concentrate SeparationKitwithACD-Aisdesignedtobeusedforthesafeandrapidpreparationofconcen-tratedplatelet-poor-plasma(PPPc)andautologousplatelet-rich-plasma(PRP)fromasmallsam-pleofbloodatthepatient’spointofcare.ThePPPcandPRPcanbemixedwithautograftandallograft bone prior to application to an orthopedic surgical site as deemed necessary by theclinicaluserequirements. CONTRAINDICATIONS 1.Useasadialyzerorfordialysiswithadialysate. 2.Directconnectiontopatient’svascularsystemofcirculatingbloodvolume. WARNINGS AND PRECAUTIONS 1. Usepropersafetyprecautionstoguardagainstneedlesticks. 2.Follow manufacturer instructions when using the centrifuge. Use only a Biomet Biologics

centrifuge(GPS®–IECcentrifugeorDruckerCompanycentrifuge).Outcomesusingcentri-fugesfromothermanufacturersareunknown.

3.Donotusesterilecomponentsofthiskitifpackageisopenedordamaged. 4.Singleusedevice.Donotreuse. 5.Thesurgeonistobethoroughlyfamiliarwiththeequipmentandthesurgicalprocedureprior

tousingthisdevice. 6.Thepatientistobemadeawareofthegeneralrisksassociatedwithtreatmentandpossible

adverseeffects. 7.UsepreparedPPPcandPRPwithin4hoursafterdrawingbloodfrompatient,accordingto

AABBguidelines. 8.Thesafetyandeffectivenessforbonehealingandhemostasishavenotbeenestablished. POSSIBLE ADVERSE EFFECTS 1.Damagetobloodvessels,hematoma,delayedwoundhealingand/orinfection. 2. Temporaryorpermanentnervedamagethatmayresultinpainornumbness. 3.Earlyorlatepostoperativeinfection. STERILITY ThePlasmax™PlusPlasmaConcentratorAccessoryandtheGPS® III platelet separator are steril-izedbyexposuretoaminimumdoseof25kGygammaradiation.Allothercomponentsaresteril-izedbytherespectivesuppliersusingradiationorethyleneoxidegas(ETO).Donotre-sterilize.Donotuseafterexpirationdate. INSTRUCTIONS FOR USE NOTE: Use standard aseptic technique throughout the following procedures. PROCEDURE ONE:UsetheGPS®IIIPlateletConcentrateSeparationKitwithACD-Atoprepareplatelet-poor-plasma(PPP)andPRP. 1. DRAW:Draw5mlofACD-A into60mlsyringe,attach to18-gaugeapheresisneedleand

primewithACD-A.Slowlydraw55mlofpatient’sownblood intothe60mlsyringeprimedwith ACD-A. Gently, but thoroughly mix the whole blood and ACD-A upon collection topreventcoagulation.

2.LOAD: ENSURE BLOOD FROM ONLY ONE PATIENT IS PROCESSED PER SPIN,and that the platelet separator remains upright.Unscrewclearcaponcenterbloodport#1.Removeanddiscardcapandgreenpackagingpost.Slowly loadblood-filled60mlsyringe(5mlofACD-Amixedwith55mlofpatient’swholeblood)intocenterbloodport#1.Unscrew

anddiscardclearprotectiveinnerpiecefromwhitecaptetheredtoport#1.Screwwhitecapontoport#1.PlaceplateletseparatorfilledwithanticoagulatedbloodinaBiometBiologicscentrifuge.

3.BALANCE:FillblueGPS®counterbalancetube(800-0508)with60mlofsterilesaline/water(equaltoamountofwholebloodplusACD-Adispensedintheplateletseparator).Placefilledcounterbalancedirectlyoppositefromtheblood-filledplateletseparatorinthecentrifuge.

4.SPIN:Closecentrifugelid.SetRPMto3.2(x1,000)andthetimeto15minutes.Pressthestartbutton.Oncespiniscomplete,opencentrifuge.

5.EXTRACT PPP:Unscrewyellowcaponport#2,andsaveyellowcap.Connect30mlsyringetoport#2,invertplateletseparator,andextractexactly25mlofPPP.Remove30mlsyringefromport#2,capwithasterilesyringecap,andsetaside.Replaceyellowcaponport#2.

6.If PRP is desired, follow steps 7 – 8. 7.SUSPEND PRP:Holdingplateletseparatorintheuprightposition,unscrewredcaponport

#3.Attacha10mlsyringetoport#3.Extract2mlofPRPinthe10mlsyringe.Leavethe10mlsyringeattachedtoport#3.Shakeplateletseparatorgentlyfor30seconds.

8.EXTRACT PRP:Immediatelyaftersuspendingtheplatelets,extractremainingPRPintotheattached10mlsyringe.Remove10mlsyringe fromport#3,andcapwithasterilesyringecap.

PROCEDURE TWO:UsethePlasmax™PlusPlasmaConcentratorAccessorytopreparePPPc. 1.LOAD:Unscrewcaponport#1.Slowly loadthe25mlPPPcollected in30mlsyringe into

port#1.Unscrewanddiscardclear,protectiveinnerpiecefromwhitecaptetheredtoport#1.Screwwhitecapontoport#1.

2.MIX: Twist and piston the mixing paddle for 30 seconds. Be sure to push and twist thepaddletothefloorofthePlasmax™PlusPlasmaConcentratorAccessory’supperchambertosaturatethebeads.Thereshouldbenowhitebeadsvisible.Placeintocentrifuge.

3.BALANCE: Place the green Plasmax™ Plus counterbalance (800-0512) directly oppositefromthePlasmax™PlusPlasmaConcentratorAccessoryinthecentrifuge.

4.SPIN:ClosecentrifugelidandsetRPMto2.0(x1,000)andthetimeto2minutes.Pressthestartbutton.Oncespiniscomplete,opencentrifuge.

5.EXTRACT PPPc:Unscrewredcaponport#2andextractPPPcusingasterile10mlsyringe.Remove10mlsyringefromport#2,andcapwithasterilesyringecap.

Caution:Federallaw(USA)limitsthisdevicetosaleorusebyorontheorderofaphysician. CommentsregardingthisdevicecanbedirectedtoAttn:RegulatoryDept.,Biomet,P.O.Box587,Warsaw,IN46581USA,FAX:574-372-1683. GPSisaregisteredtrademarkofBiometManufacturingCorp.intheUnitedStates.

All trademarks herein are property of Biomet, Inc. or its subsidiaries unlessotherwiseindicated.

ThismaterialisintendedforthesoleuseandbenefitoftheBiometBiologicssalesforceandphysicians.Itisnottoberedistributed,duplicated,ordisclosedwithouttheexpresswrittenconsentofBiomet.

P.O.Box587,Warsaw,IN46581-0587•800.348.9500ext.1501 ©2008BiometOrthopedics•www.biomet.com

FormNo.BBI0020.0•REV061508

BIOLOGICS

References 1.Data on file at Biomet BiologicsTM, LLC. Bench test results are not

necessarilyindicativeofclinicalperformance.

plasmax gpsiii brch

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