參考ems dental產品說明書instructions

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

Mustbesterilizedatupto135°CintheSuitableforthermal 4/9/20154:12:01 請在開始工作前仔細 存在人 風請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溫度進行滅適合高 4/9/20154:12:01AboutthisTheinstructionsinthismanualareonlyapplicabletotheequipmentitwasdeliveredwith.NotethattheEnglishversionofthismanualisthemasterfromwhichtranslationsderive.Incaseofanydiscrepancy,thebindingversionistheEnglishtext.Wewouldbepleasedtoansweryourquestionsorlistentoyoursuggestions.Wedo,ofcourse,providesupportincaseoftechnicalproblems.PleasecalldirectlyyourapprovedEMSrepaircenteroryourWewishyoulotsofEMS 4/9/20154:12:01 關于本手 樂意解答您的問題或聽取您的建議。當然，如果遇到技術問題， 準的EMS維修中心或您的經銷商。 4/9/20154:12:01 intendedtobereprocessedinmedicalfacilities.Thegoalofreprocessingreusableproductsistoreducebioburdenandtoachievesterilityofthoseproductsinordertoeliminatetheriskofproductreuserelatedinfection.Decisionsregardingcleaning,disinfectingorsterilizingEMSmedicalanddentalinstrumentsarebasedonthepotentialriskofinfectionassociatedwiththeiruse.Itismendedto achievedunlesstheelementsoftheassemblyarecleanedIfthereisanythinginthefollowinginstructionsthatisnotclear,donothesitatetocontactEMSinNyon.seemtobeinadequate,pleaseWeencourageyoutoreportadverseeventsrelatedtodevicereprocessing.ReportsucheventsdirectlytoEMSinNyon. 4/9/20154:12:01 簡這些重新處理說明介紹了如何對可在醫(yī)療機構內重新處理的EMS可重復使用產品進行清潔、 染風險。應根據與使用EMS醫(yī)療和牙科器械相關的潛在 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應用57步驟 手動和機械重新處理 機械清潔 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 可重復使用產品的重新處理說 ?重要事使用前，請仔細閱讀EMS器械以及將與該產品一（ （3 4/9/20154:12:02BasicItisonlypossibletocarryouteffectivesterilizationafterthecompletionofeffectivecleaninganddisinfection.Pleaseensurethat,aspartofyourresponsibilityforthesterilityofproductsduringuse,onlysufficientlyvalidatedequipmentandproduct-specificproceduresareusedforcleaning/disinfectionandsterilization,andthatthevalidatedparametersareadheredtoduringeverycycle.Pleasealsoobservetheapplicablelegalrequirementsinyourcountryaswellasthehygieneregula-tionsofthehospitalorclinic.Thisappliesespeciallywithregardtotheadditionalrequirementsfortheinactivationofprions.4 4/9/20154:12:02 預 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 手動和機械重新須在清潔階段過后的2個小時之內進 9 4/9/20154:12:02 MECHANICALCLEANINGANDThermaldisinfectionshouldbeusedifthisfunctionisavailableonyourdisinfector.UseifpossibleadisinfectingcyclecompliantwiththestandardENISO15883.Notethatthereisariskofdisinfectantresidueonproductswhenusingchemicaldisinfectants.Ensurethefollowingcriteriaaremetwhenselectingadisinfectorsystem: enttoproductlumina.(E.g.Aquapurificata,asperthespecificationsofPharm.Eur.orUSP). 4/9/20154:12:02 機械清潔 可能，采用符合ENISO15883標準的 用于干燥的空氣經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（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驗證符ENIS0最高滅菌溫度 285進行驗證）。在驗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 、和遵守相應的有效標準（ENIS014937/ANSIAAMlIS014937），并驗證程序的本質 4/9/20154:12:02SERVICETheproductshavebeendesignedforalargenumberofsterilizationcycles.Thematerialsusedintheirmanufacturewereselectedaccordingly.Howeverwitheveryrenewedpreparationforuse,thermalandchemicalstresseswillresultinageingoftheproducts.Ifthenumberofpermissiblere-