參考ems dental產(chǎn)品說明書instructions

Caution!Federal(USA)lawrestrictsthisdevicetosalebyorontheorderCaution!Federal(USA)lawrestrictsthisdevicetosalebyorontheorderofadentist. PLEASEREADTHISBEFOREBEGINNINGPleasereadtheseoperatinginstructionscarefullyastheyex inallthemostimportantdetailsandprocedures.Pleasepayspecialattentiontothesafetyprecautions.AlwayskeepthisinstructioncloseatTopreventinjurytopeopleanddamagetoproperty,pleaseheedthecorrespondingdirectives.Theyaremarkedasfollows:RiskofRiskofpropertydamageorenvironmentalPlease

Mustbesterilizedatupto135°CintheSuitableforthermal 4/9/20154:12:01 請(qǐng)?jiān)陂_始工作前仔細(xì) 存在人 風(fēng)請(qǐng)注其他有用的信息和提允

必須在高壓滅菌器中以最高135°C溫度進(jìn)行滅適合高 4/9/20154:12:01AboutthisTheinstructionsinthismanualareonlyapplicabletotheequipmentitwasdeliveredwith.NotethattheEnglishversionofthismanualisthemasterfromwhichtranslationsderive.Incaseofanydiscrepancy,thebindingversionistheEnglishtext.Wewouldbepleasedtoansweryourquestionsorlistentoyoursuggestions.Wedo,ofcourse,providesupportincaseoftechnicalproblems.PleasecalldirectlyyourapprovedEMSrepaircenteroryourWewishyoulotsofEMS 4/9/20154:12:01 關(guān)于本手 樂意解答您的問題或聽取您的建議。當(dāng)然，如果遇到技術(shù)問題， 準(zhǔn)的EMS維修中心或您的經(jīng)銷商。 4/9/20154:12:01 intendedtobereprocessedinmedicalfacilities.Thegoalofreprocessingreusableproductsistoreducebioburdenandtoachievesterilityofthoseproductsinordertoeliminatetheriskofproductreuserelatedinfection.Decisionsregardingcleaning,disinfectingorsterilizingEMSmedicalanddentalinstrumentsarebasedonthepotentialriskofinfectionassociatedwiththeiruse.Itismendedto achievedunlesstheelementsoftheassemblyarecleanedIfthereisanythinginthefollowinginstructionsthatisnotclear,donothesitatetocontactEMSinNyon.seemtobeinadequate,pleaseWeencourageyoutoreportadverseeventsrelatedtodevicereprocessing.ReportsucheventsdirectlytoEMSinNyon. 4/9/20154:12:01 簡(jiǎn)這些重新處理說明介紹了如何對(duì)可在醫(yī)療機(jī)構(gòu)內(nèi)重新處理的EMS可重復(fù)使用產(chǎn)品進(jìn)行清潔、 染風(fēng)險(xiǎn)。應(yīng)根據(jù)與使用EMS醫(yī)療和牙科器械相關(guān)的潛在 建議使用蒸汽滅菌 Nyon的EMS。 Nyon的EMS。我 Nyon的EMS 4/9/20154:12:01Reprocessinginstructionsforreusable224Basic Post-operativetreatment6 Manualandmechanical8MechanicalcleaningandStepsformechanicalcleaninganddisinfectionwitha Stepsformanual Stepsformanual InspectionandPackagingandsterilizationServicelife 4/9/20154:12:01 3應(yīng)用57步驟 手動(dòng)和機(jī)械重新處理 機(jī)械清潔 的步驟15驟19212325 4/9/20154:12:01 REPROCESSINGINSTRUCTIONSFORREUSABLETheinstructionsarebindingforthereprocessingofallreusableproducts*ofEMS.Whennecessary,additionalproduct-specificinstructionsareincludedwiththeproducttoprovideadditional*(HereaftercalledBeforeuse,carefullyreadtheoperatinginstructionsoftheEMSinstrumentanddeviceswithwhichtheproductwillbeused.Reusableproductsmustbecleanedandsterilizedpriortofirstuse.Theymustberecedafterthenumberofoperationsspecifiedbythemanufacturer.Disposableproducts(singleuse)cannotbe2 4/9/20154:12:02 可重復(fù)使用產(chǎn)品的重新處理說 ?重要事使用前，請(qǐng)仔細(xì)閱讀EMS器械以及將與該產(chǎn)品一（ （3 4/9/20154:12:02BasicItisonlypossibletocarryouteffectivesterilizationafterthecompletionofeffectivecleaninganddisinfection.Pleaseensurethat,aspartofyourresponsibilityforthesterilityofproductsduringuse,onlysufficientlyvalidatedequipmentandproduct-specificproceduresareusedforcleaning/disinfectionandsterilization,andthatthevalidatedparametersareadheredtoduringeverycycle.Pleasealsoobservetheapplicablelegalrequirementsinyourcountryaswellasthehygieneregula-tionsofthehospitalorclinic.Thisappliesespeciallywithregardtotheadditionalrequirementsfortheinactivationofprions.4 4/9/20154:12:02 預(yù) 5 4/9/20154:12:02 POST-OPERATIVEThepost-operativetreatmentmustbecarriedoutimmediay,nolaterthan30minutesafterthecompletionoftheoperation.Additionalinformation,wherenecessary,isprovidedintherespectiveproduct-specificusageinstructions.RinseawayanysurfacesoilingontheproductwithdistilleddeionizedwaterorwithacleaningRinsethroughalllumina(e.g.irrigationandaspirationconnection)atleast3timesinthenormaldirectionofflow(nobackrinsing)usingadisposablesyringe(min.volume50ml)filledwithdistilled/deionizedwaterappliedtothebacknozzle.Analdehyde-cleaninganddisinfectionsolutionthatiscompatiblewiththeproductsmayalsobeusedasanalternativerinsingsolution.Insuchcases,itisnecessarytorinsethoroughlyafterwardsatleast3timeswithdistilled,ordeionizedwater.6 4/9/20154:12:02 術(shù)后處分息。 和抽吸連接處）至少3次。 至少3次。7 4/9/20154:12:02MANUALANDMECHANICALDisinfectionmustbeperformednolaterthan2hoursafterthecleaningphase.Amachinecleaninganddisinfectionmethodshouldalwaysbeusedforcleaning/disinfectionbecauseoftheincreasedeffectivenessofthismethod.8 4/9/20154:12:02 清潔 手動(dòng)和機(jī)械重新須在清潔階段過后的2個(gè)小時(shí)之內(nèi)進(jìn) 9 4/9/20154:12:02 MECHANICALCLEANINGANDThermaldisinfectionshouldbeusedifthisfunctionisavailableonyourdisinfector.UseifpossibleadisinfectingcyclecompliantwiththestandardENISO15883.Notethatthereisariskofdisinfectantresidueonproductswhenusingchemicaldisinfectants.Ensurethefollowingcriteriaaremetwhenselectingadisinfectorsystem: enttoproductlumina.(E.g.Aquapurificata,asperthespecificationsofPharm.Eur.orUSP). 4/9/20154:12:02 機(jī)械清潔 可能，采用符合ENISO15883標(biāo)準(zhǔn)的 用于干燥的空氣經(jīng)HEPA過濾 4/9/20154:12:02EnsurethefollowingcriteriaaremetwhenselectingacleaninganddisinfectionCEmarked),thatiscompatiblewiththecleaningagent,mustbeused.Concentrationsandcontacttimesspecifiedbythemanufacturerofthecleaninganddisinfectionagentmustbefollowed.Onlyfreshlypreparedsolutionsmaybeused. 4/9/20154:12:02 劑制造商指定的濃度和接觸時(shí)間。僅可使用剛 4/9/20154:12:02 StepsformechanicalcleaninganddisinfectionwithaCarefullycetheproductsinthedisinfectionbasket.Fasteningoftheproductsisonlypermissibleiftheyarelymoveableinthefixture.Theproductsarenotpermittedtomakecontactwithoneanother.Usingasuitablerinsingadaptor,connecttheproductluminatotherinsingconnectionsoftheStarttheRemovetheproductsfromthedisinfectorandstarttheinspection(seesectionInspectionandmaintenance)aftertheprogramends.Ifnecessary,repeatdryingoftheproductinaclean Verificationofthefundamentalsuitabilityoftheproductsforeffectivecleaninganddisinfectionbymachinewasprovidedbyanindependent,accreditedtestinglaboratorywhenusedwiththeG7736CDdisinfector,Miele&Cie.GmbH&Co.,Gutersloh,(thermaldisinfection),andthecleaningagentNeodisher?Medizym(Dr.WeigertGmbH&Co.KG,Hamburg).Theproceduredescribedabovewasadheredtoaspartofthis. 4/9/20154:12:02 Miele&CieGmbH&Co?Gutersloh提供的G7736CD機(jī)（高溫）和Neodisher?潔和的 4/9/20154:12:02 MANUALWhenselectingthecleaningand/ordisinfectionagenttobeused,ensurewithoneanother,Itisabsoluyessentialthattheconcentrationsandcontacttimesspecifiedbythemanufacturerofthecleaninganddisinfectionagentareadheredto.Onlyfreshlypreparedsolutionsmaybeused.Thedisinfectantsolutionisnotpermittedtofoam.Onlysterilizedorlowmicrobecountdistilled/deionizedwater(<10cfu/ml)canbeusedforallrinsingsteps.Alsoensurethepresenceofasufficientlylowendotoxinandparticleconcentration(e.g.Aquapurificata,asperthespecificationsofPharm.Eur.orUSP). 4/9/20154:12:02 序 的溶液。不允 ? 藥典》規(guī)定的純凈水）。 4/9/20154:12:02 StepsformanualCompleydisassemblethehandpieceandinstruments,if cetheproductsinthecleaningsolutionforatleasttheminimumthetimeandtheconcentrationspecifiedbythemanufacturerofthecleaning/disinfectionagent.Removeanyexternally-attachedsoilingbybrushingcarefullywithasoftbrushorasoftRinsetheproductsvigorouslyatleastfivetimes,eachtimewithfreshdistilledordeionizedwater(eachproductlumenwithatleast50mlofwater).Repeatthecleaningprocessifthelastrinsingdoesnotrunclear,orifstainsarestillvisibleontheproduct. 4/9/20154:12:02 4/9/20154:12:02 Stepsformanual cetheproductsinthedisinfectionsolutionforatleasttheminimumthetimespecifiedbythemanufacturerofthedisinfectionagent.Useanaldehyde-disinfectionsolutionforcleaninggeneralandsurgicalinstruments.Ifapplicable:rinsealllumensoftheinstrumentfivetimesatthebeginningandattheendofthesoakingtimewithasingleusesyringe(minimalvolumeof50ml).RemovetheinstrumentfromthecleaningsolutionandpostrinsethemintensivelywithalowcontaminatedanddeionizedwaterDrytheproductswithfilteredcompressedair(max.3Ifnecessary,repeatdryingoftheproductinacleance.Verificationofthefundamentalsuitabilityoftheproductsforeffectivemanualcleaninganddisinfectionwasprovidedbyanindependent,accreditedtestinglaboratoryforuseofthefollowingcleaning/disinfectionagents:ForhandpieceFD350(fromDürrGmbH)andfortheinstrumentsID212(fromDürrGmbH).Theproceduredescribedabovewasadheredtoaspartofthis. 4/9/20154:12:02 4/9/20154:12:02Ifstainsarestillvisibleontheproductaftercleaning/disinfection,theentirecleaning/disinfectionproceduremustberepeated.Productswithvisibledamage,chip/flakeloss,corrosionorbentoutofshapemustbedisposedof(nofurtheruseispermissible). 4/9/20154:12:02 檢查 4/9/20154:12:02 Donotexceed umnumberofsterilizationOnlycleanedanddisinfectedproductsarepermittedtobesterilized.Priortosterilization,theproductsneedtobe cedinasuitablesterilizationcontainer: Ifdouble,single-usesterilizationpackaging(doublebag)istobeused,thismustalsocomplywithENISO11607andbesuitablefor sterilization(temperatureresistantto138°Cwithadequate Useonlythefollowinglisted arenotpermissible:Fractionalpre-vacuum 4/9/20154:12:02 包裝和滅超出滅菌周期的最大數(shù)量 符合ENISO 4/9/20154:12:02 Verificationofthefundamentalsuitabilityoftheproductsforeffective sterilizationwasprovidedbyanindependent,accreditedtestinglaboratoryforuseofthefractionatedvacuumprocedure.(EuroSelectomatfromMMMMünchenerMedizinMechanikGmbH, negg,validatedaccordingtoDINEN285).Theproceduredescribedabovewasadheredtoaspartofthis.Thehot-airsterilizationandradio-sterilizationproceduremaynotbeused(asitcausesthedestructionofproducts). 4/9/20154:12:02 蒸汽滅菌器符合EN13060EN285驗(yàn)證符ENIS0最高滅菌溫度 285進(jìn)行驗(yàn)證）。在驗(yàn)證過程中遵守了上述程序。 4/9/20154:12:02 Themanufacturerassumesnoresponsibilityfortheuseofothersterilizationprocedures(e.g.ethyleneoxide,formaldehydeandlowtemperaturesmasterilization).Insuchcases,pleaseobservetheverifythesuitabilityandeffectivenessinprincipleoftheprocedure(ifnecessary,includinginvestigationsonsterilizingagentresidue),takingintoaccountthespecificproductgeometryaspartofthevalidation. 4/9/20154:12:02 、和遵守相應(yīng)的有效標(biāo)準(zhǔn)（ENIS014937/ANSIAAMlIS014937），并驗(yàn)證程序的本質(zhì) 4/9/20154:12:02SERVICETheproductshavebeendesignedforalargenumberofsterilizationcycles.Thematerialsusedintheirmanufacturewereselectedaccordingly.Howeverwitheveryrenewedpreparationforuse,thermalandchemicalstresseswillresultinageingoftheproducts.Ifthenumberofpermissiblere-