3M-Attest-1264-1264P-Biological-Indicator-产品说明书(中英文对照)-Jimizhi1

MTMAttestTM1264/1264PBiologicalIndicator生物指示剂Productdescription:The3MAttest1264BiologicalIndicator(greencap)isdesignedformonitoringofEOsterilizationprocess.ThepresenceofBacillusatrophaeussporesisdetectedbyavisualcolorchange(mediaturnsyellow).Theyellowcolorchangeindicatesasterilizationprocessfailure.Thefinalreadoutofanegativeresult(mediaremainsgreen)ismadeafter48hoursofincubation.产品描述：3MAttest1264生物指示剂（绿帽）用来监测环氧乙烷灭菌过程。可通过视觉上的颜色变化（培养基变成黄色）来检测枯草杆菌芽孢是否存在。如果培养基变成黄色，则表明灭菌过程失败；如果培养基保持绿色不变，经48小时潜伏期后，最终得到阴性结果。Monitoringfrequency:Attestbiologicalindicatorsshouldbeplacedinanappropriatetesttrayorpackage,andbeusedtomonitoreveryload.Thispresentsanappropriatechallengeandimprovestheperformanceofthesterilizationprocess.监测频率：Attest生物指示剂应放置在适当的测试盘或包装内，以便监测每一个负载。此方法对灭菌过程来说是一个挑战，它提高了灭菌过程的成效。Indications:UsetheAttest1264BiologicalIndicatortomonitor:Allethyleneoxidesterilizationcycles.说明：使用Attest1264生物指示剂监测：1.所有环氧乙烷灭菌的循环过程。Contraindications:None.禁忌：无。Warning:Thereisaglassampuleinsidetheplasticvialofthebiologicalindicator.Crushingorexcessivehandlingofthebiologicalindicatorbeforecoolingmaycausetheglassampuletoburst.Wearsafetyglassesandgloveswhenremovingthebiologicalindicatorfromthesterilizer.Wearsafetyglasseswhencrushingthebiologicalindicator.Handlethebiologicalindicatorbythecapwhencrushingandtapping.Donotuseyourfingerstocrushtheglassampule.Donotrollthebiologicalindicatorbetweenfingerstowetthesporestrip.警告：在生物指示剂的塑料瓶里有一个玻璃安瓿。冷却前生物指示剂的压破或者过度操作都会引起玻璃安瓿破裂。从灭菌器中移出生物指示剂时，应配戴安全防护眼镜和手套。当压破生物指示剂时，应配戴安全防护眼镜。当压破和轻敲生物指示剂时，通过握紧帽子进行操作。禁止使用手指破碎玻璃安瓿禁止在手指间摇动生物指示剂，该行为会使狍子带湿润。Precautions:DonotusetheAttest1264BiologicalIndicatortomonitor:Steamsterilizationcycles.Dryheat,chemicalvapor,orotherlowtemperaturesterilizationprocess.注意事项：禁止使用Attest1264生物指示剂监测：循环蒸汽灭菌。干燥加热、化学蒸汽或者其他低温灭菌过程。Directionsforuse:IdentifytheAttestbiologicalindicatorsbywritingthesterilizer,loadnumber,andprocessingdateontheindicatorlabel.PlaceanAttestbiologicalindicatorinanappropriatetesttrayorpackageaccordingtorecommendedpractices.Appropriatetesttraysorpackagesforloadscontaining:Wrappedtelescopicinstruments,plastic,rubber,metalinstruments,andequipment.Attest1264BiologicalIndicatorinanAAMIsyringepack.ContainersystemsAttest1264BiologicalIndicatorintheareasdeterminedbyproducttestingtobethemostresistant.Placethetesttrayorpackageinafullloadinthemostchallengingareaforthesterilant.Thisisgenerallyinthecenteroftheroad.Processtheloadasusual.Aftersterilizationtwooptionsexist:A.Openthesterilizerdooraccordingtothemanufacturer’sinstructions;transfertheloadtotheaeratorandretrievethetestpack.(Ifasterilizerwithaerationcapabilityisused,followthemanufacturer’sinstructionsforopeningthedoorandremovethetestpackpriortotheaerationcycle.)Removethebiologicalandchemicalindicatorfromthetestpack.Returntheremainderofthetestpacktotheloadforaerationaccordingtothehealthcarefacility’spolicy.B.AerationoftestpackpriortoincubationAeratetheotherpacksfromtheloadforthesameamountoftimeasthetestpack.Attheendoftheaerationcycle,removethebiologicalandchemicalindicatorfromthetestpack.Disposeoftheremainingtestpackcomponentsaccordingtothehealthcarefacility’spolicy.Checkthechemicalindicatoronthelabelofthebiologicalindicator.AcolorchangetogreenconfirmsthatthebiologicalindicatorhasbeenexposedtotheEOsterilizationprocess.Thecolorchangedoesnotindicatethattheprocesswassufficienttoachievesterility.Ifthechemicalindicatorisunchanged,checkthesterilizationprocess.Incubatethebiologicalindicatorat37±2°C(99±3°F).AttestIncubator120volt(NorthAmericanUsage)240volt(InternationalUsage)Model117(14indicators)Model117(14indicators)

Model127(28indicators)Model127(28indicators)

BottomtierofModel130(14indicators)BottomtierofModel131(14indicators)A.Positionindicatorinmetalblock(seeFigure1).Placebottomoftheindicatorintotheincubator’smetalheatingblocksothattheindicatorisatanangleofapproximately45°.B.Pushtheindicatorstraightback(seeFigure2).Thiscrushesthemediaampuleandactivatestheindicator.Besurethatthecapwillremainabovethemetalblockwhentheindicatorispushedback.C.Pushtheactivatedindicatordowntoseatitinthemetalheatingblock.(SeeFigure3).Besurethatthecapremainsabovethemetalblockwhenseatedintheincubator.Incubateatleastonenon-processedAttestbiologicalindicator(positivecontrol)eachdayaprocessedindicatorisincubated.Thepositivecontrolindicatorshouldbefromthesamemanufacturingdateandlotnumberastheprocessedindicatorintheincubator.Writea“C”andadateonthelabelofthepositivecontrolindicator.Crushandincubatethecontrolat37±2°C(99±3°F).Thepurposeofthepositivecontrolistoensure:correctincubationconditionsviabilityofindicators(incorrectstorageconditionscouldadverselyaffecteventhoseindicatorswhicharewithintheirstatedshelflife)capabilityofmediatopromoterapidgrowthIncubatetheprocessedandcontrolbiologicalindicatorsfor48hoursat37±2°C(99±3°F).Incubationtimes:Earlydetection12hours18hours24hoursFinaldetection48hoursTheappearanceofayellowcolorintheprocessedindicatordemonstratesbacterialgrowthandasterilizationprocessfailure.Nocolorchangeindicatesanadequatesterilizationprocess.Afinalnegativeresultismadeafter48hoursofincubation.Thepositivecontrolindicatorshouldshowayellowcolorchangefortheprocessedindicatorresultstobevalid.Recordtheprocessedandcontrolbiologicalindicatorresults.Actonanypositivetestassoonasthefirstevidenceofgrowthisnoted.Alwaysretestthesterilizeranddonotusethesterilizeruntilthebiologicalindicatortestresultsarenegative.使用说明：通过指示标签上的灭菌器、负载数量和加工日期来鉴别生物培养指示剂。根据推荐的做法，在适当的测试盘或包装内放置一个生物指示剂。可负载的适当的测试盘或包装包括：包装伸缩工具，塑料、橡胶、金属工具和设备。在一个AAMI注射器里的Attest1264生物指示剂容纳体系Attest1264生物指示剂置于测试产品最难测的区域。将全负载的测试盘或包装放在灭菌最难的区域，通常是在中心区域。按常规处理负载。灭菌后的两个选择：A.根据制造商说明书打开灭菌器柜门；转移负载到曝气装置并取回测试包。（如果使用有曝气能力的灭菌器，按照制造商指示，在曝气周期之前打开柜门并拆下测试包。）从测试包拆下生物和化学指示剂。根据医疗保健设施政策，将测试包剩余部分返回到曝气装置。B.保温前测试包的曝气曝气负载中的与测试包的灭菌时间相同的其他包。在曝气周期结束时，从测试包拆下生物和化学指示剂。根据医疗保健设施政策，处理剩余的测试包部件。检查生物指示剂标签上的化学指示剂。颜色变成绿色可确认生物指示剂已经过EO灭菌过程。颜色的变化并不能表明此过程已达到无菌。如果化学指示剂不变色，检查灭菌过程。生物指示剂保温温度为37±2°C。Attest保温箱120伏（北美使用）240伏（国际使用）模型117（14项指标）模型117（14项指标）模型127（28项指标）模型127（28项指标）底层模型130（14个指标）底层模型131（14个指标）A.在金属块中的指示剂位置（见图1）。将该指示剂底部放置在保温箱的金属加热座上，使该指示剂处于约45度的角度。B.将指示剂向后径直推（见图2）。这将压碎其中的安瓿并激活指示剂。当指示剂向后推时，确保盖子位于金属块上方。C.向下按压已被激活的指示剂，使其稳固于金属加热区。（见图3）。当指示剂向下按压时，确保盖子位于金属块上方。每天至少培养一个未处理的Attest生物指示剂（阳性对照）。在保温器中，阳性对照指示剂与所处理指示剂应当是同一制造日期和批号。在阳性对照指示剂的标签上写上“C”和日期。在37±2°C破碎并培养阳性对照指示剂。培养阳性对照指示剂的目的是为了确保：正确的培养环境指示剂的活性（不当的储存环境会对即使在规定保质期内的指示剂产生不利影响）培养基的功效是促进其快速增长在37±2°C将处理过的生物指示剂以及阳性指示剂培养48小时。培养时间：早期监测12小时18小时24小时最终监测48小时所处理指示剂呈现黄色，表明细菌增长以及灭菌过程失败。无颜色改变则表明灭菌过程适当。培养48小时后，最终将得到一个阴性结果。相对于所处理的指示剂，阳性对照指示剂应当呈现黄色变化以表明其有效。记录所处理指示剂和阳性对照指示剂的结果。一旦首个增长证据被记录，即为阳性测试结果。在使用和不使用灭菌器的两种情况下，反复测试，直到生物指示剂的测试结果为阴性。Dispos