Post on 22-Jan-2017
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.
Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) Preparation with GPS® III SystemTechniquedescribesPlasmax®PlusConcentrationSystem(800-0517)
StepThree:PPPandPRPExtraction(Continued)
With 10ml syringe attached, suspend the platelets
bygentlyshakingthetubefor30seconds.
Extracttheremainingplateletrichplasma(PRP)into
theattached10mlsyringe.
Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) Preparation with GPS® III SystemTechniquedescribesPlasmax®PlusConcentrationSystem(800-0517)
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.