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1、常玉醫療器材有限公司常玉醫療器材有限公司Champ Medics Co.,Ltd.報告人報告人:華子玲華子玲AsahiHemofilter產品介紹I.CompanyIntroductioni.Historyii.Manufacturing&QualityControliii.R&DII.MembraneUsedIII.BiocompabilityComparisonIV.GeneralSpecificationV.DetailSpecificationVI.IndicationofCRRTVII.ClinicalReportVIII.NHIReimbursementAboutAsahiMedi
2、calCo.,Ltd.AsahiMedicalisaworldleaderinresearch,development,andproductionofdevicesandsystemsforbloodtreatmentandpurificationbasedonadvancedmembraneseparationandadsorptiontechnologies.Itservestheglobalmarketwithdialysisproducts,plasmatherapyproducts,andbloodtransfusionproductsformedicaltherapyinmanyc
3、ountries.TheAsahiMedicaltraditionofleadershipinmembraneandrelatedbloodtreatmenttechnologiesspansseveraldecadesofdedicatedandcontinuingresearchanddevelopmentthatdrawandbuildonthefundamentalstrengthsofitsparentcompanyinfibers,biotechnology,andothermaterialsandprocesstechnologies.AsahiMedicalwasfounded
4、in1974asawhollyownedsubsidiaryofAsahiKaseiCorporation.Inthesameyear,itintroducedtheworldsfirstcuprammoniumrayonhollowfiberdialyzer,aproductofhollowfiberdevelopmentbegunthreeyearsearlierinAsahiKaseiCorporation.Thetraditionhasgrownthroughoutthefollowingdecades,basedoncontinuingresearchanddevelopment,e
5、xperienceandservice,andexpertiseinthecharacteristicsandeffectsofbloodtreatmentwithmembranesandotherseparationsystems.Now,asalways,itisdedicatedtoservingandadvancingmedicaltherapy,forthepreservationandenhancementofhumanlife.I.AsahiMedicalCo.,Ltd.History197119731974197519791981198419851988199019921994
6、1995199619992000Initiationofhollow-fiberdialyzerdevelopment,byAsahiKaseiCorporationFormationofMedicalDevicesDevelopmentDivision,inAsahiKaseiCorporationFoundingofAsahiMedicalCo.,Ltd.Introductionofcuprammoniumrayonhollow-fiberdialyzerEstablishmentofOitaPlantIntroductionofHemosorbadetoxicationcharcoalc
7、olumnIntroductionofpolyacrylonitrilehollow-fiberdialyzerIntroductionofPlasmaflomembrane-typeplasmaseparatorFoundingofAsahiMedicalGmbH,GermanyIntroductionofCascadeflomembrane-typeplasmacomponentseparatorIntroductionofSepacellleukocytereductionfilterIntroductionofImmusorbaimmunoadsorptioncolumnIntrodu
8、ctionofPlasorbabilirubinadsorptioncolumnIntroductionofAM-BIOdialyzers,withtheAsahiBiomembraneEstablishmentofMedicalEquipmentDevelopmentCenter,atFujiCityISO9001certificationandCEMarkauthorizationEstablishmentofpolysulfonemembraneplant,atNobeokaCityIntroductionofAPSpolysulfonedialyzerEstablishmentofAs
9、ahiMedicalCo.,Ltd.U.S.RepresentativeOfficeExpansionofAPSpolysulfonedialyzerproductioncapacityEstablishmentofnewSepacellplant,atOitaPlantsiteEstablishmentofnewSepacellplant,atOitaPlantsiteAsahiKaseiGroupAsakeymemberoftheAsahiKaseiGroupandasubsidiaryofAsahiKaseiCorporation,AsahiMedicalbenefitsdirectly
10、fromtheirmultidisciplinaryknowledge,expertise,andresourcesinresearchanddevelopment,materialsproductionandsupply,andproductandsystemtechnologies.AsahiKaseiCorporationisoneofJapanslargest,mostdiversifiedconglomerates.Itsfieldsofoperationrangefromchemicals,fibers,andperformanceplastics,tohousing,leadin
11、gedgeelectronics,andpharmaceuticalsdevelopmentandproduction,providinganunsurpassedbaseandbackgroundofexperience,knowledge,andexpertiseforAsahiMedical.ControlateveryphaseofproductionMostofourproductionmaterialsoriginateeitherwithinAsahiMedicalitselfortheAsahiKaseiGroup,facilitatingclose,effectivecont
12、rolofourproductsandprocesses,andtheassuranceofproductreliabilityforcustomersworldwide.StateoftheartmanufacturingprocessesToprovideproductsofthehighestqualityandperformanceandtokeepabreastoftheincreasingglobaldemandfortheseproducts,AsahiMedicalhasconstantlyadvancedtheprocesstechnologiesandexpandedthe
13、productioncapacitiesofitsplants,locatedatOitaandNobeokaCitiesinsouthernJapan,anditsproductionishighlyautomated,fromstartingmaterialstofinishedproducts.StrictqualitycontrolasakeycommitmentStrictqualitycontrolisperformedateachproductionstagetoensurehighstandardsandcomplywithGoodManufacturingPracticean
14、dISO9001/EN46001.AsahiMedicalwasoneofthefirstJapanesemedicaldevicemanufacturerstoobtaintheCEMarkqualification.AsahiMedicalwillcontinuallystrivetomaintainandimprovesafetyandefficacy,inallcurrentandfutureproductsI.AsahiMedicalCo.,Ltd.Manufacturing&QualityControlI.AsahiMedicalCo.,Ltd.R&DCoreCompetenceB
15、loodrelatedpolymersandmaterialsTherapeuticmembranestechnologyNonwovenfilterstechnologyAdsorptiontechnologyBlood/materialsinteractionanalysistechnologyBloodanalysisFluid,minuteconcentration,andstablecirculationtechnologiesExtracorporealtherapyanddevicetechnologiesFieldsofApplicationExtracorporealther
16、apyTransfusionbloodtreatmentSurgicalbloodtreatmentDiagnosticbloodtreatmentBloodcelltreatmentBloodrelatedmaterialsqMembraneTypeCuprRayonPolysulfone(PS)PANqUSEHDHFDHDFHFDHDFII.MembraneUsedIII.BiocompabilityComparsionVII.IndicationofC.R.R.T.Indications of CRRTDuringSIRSamodificationofMODSandMOFdevelops
17、andwithintheirframeworkthekidneymayormaynotbeaffected.Also,inconditionswithoutrenalaffection,CRRTisfullyindicatedforeliminatinginflammatorymediatorsthatdamageotherorgans.Therefore,theindicationsforCRRTaredividedintorenalandnon-renal.InMODSwithrenalfailure,bothindicationsareinterconnected.Renal indic
18、ationsTheyareobviousfromtheterm.Themainindicationisoliguricrenalfailure,inwhichitispossible to eliminate by CRRT fluid in renal hyperhydration and create more space forparenteral nutrition and drug administration.Balancing takes place as required evenlythroughout 4 hours.At the same time a stable mi
19、lieu interieur is maintained and urea,creatinine,uraemictoxinsandcytokinesareeliminatedevenly.Non-renal indicationsThisgroupcomprises:congestiveheartfailurenotrespondingtodiureticspatientswithsepsis,septicshockwithMODSandMOFpatientswithprogressingSIRSbeforedevelopmentofMODSandMOFsomeintoxicationsref
20、ractoryshiftsofthemilieuinterieur(ions,ABR)ARDS(adultrespiratorydistresssyndrome)-refractoryhyperpyrexia-preventionofthetumour-lysissyndromeVII.MolecularweightofInflammatoryMediatorMediatorMolecularweight(D)ThromboxaneA2352PAF524Leukotriens600Complement3a10000Complement5a11200Interleukin1,215000Tumo
21、rnecrosisfactoralpha17000Interleukin625000Endotoxin100000IV.GeneralSpecificationV.DetailSpecificationVI.ClinicalReport1VI.ClinicalReport2Note:PAN06atTakeyamaHospital,TokyoPAN10atSapporoMedicalCollegeFusoPharmaceutical,JapanContents:Na:140mEq/L,K:2.0mEq/L,Ca:3.5mEq/L,Mg:1.5mEq/L,Cl:107mEq/LLacticacid:0mEq/LAceticacid:40mEq/LGrapesugar:0mEq/LOsmonalityPressure:294mOsm/LVIII.NHIReimbursementHemofilter應具備的基本功能IdealultrafiltrationIdealclearanceontoxinforsmall&mediummolecularweightCosteffective謝謝各位參與謝謝各位參與!
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