3M-Attest-1264-1264P-Biological-Indicator-產(chǎn)品說明書(中英文對照)-Jimizhi1

MTMAttestTM1264/1264PBiologicalIndicator生物指示劑Productdescription:The3MAttest1264BiologicalIndicator(greencap)isdesignedformonitoringofEOsterilizationprocess.ThepresenceofBacillusatrophaeussporesisdetectedbyavisualcolorchange(mediaturnsyellow).Theyellowcolorchangeindicatesasterilizationprocessfailure.Thefinalreadoutofanegativeresult(mediaremainsgreen)ismadeafter48hoursofincubation.產(chǎn)品描述：3MAttest1264生物指示劑（綠帽）用來監(jiān)測環(huán)氧乙烷滅菌過程?？赏ㄟ^視覺上的顏色變化（培養(yǎng)基變成黃色）來檢測枯草桿菌芽孢是否存在。如果培養(yǎng)基變成黃色，則表明滅菌過程失??；如果培養(yǎng)基保持綠色不變，經(jīng)48小時潛伏期后，最終得到陰性結果。Monitoringfrequency:Attestbiologicalindicatorsshouldbeplacedinanappropriatetesttrayorpackage,andbeusedtomonitoreveryload.Thispresentsanappropriatechallengeandimprovestheperformanceofthesterilizationprocess.監(jiān)測頻率：Attest生物指示劑應放置在適當?shù)臏y試盤或包裝內，以便監(jiān)測每一個負載。此方法對滅菌過程來說是一個挑戰(zhàn)，它提高了滅菌過程的成效。Indications:UsetheAttest1264BiologicalIndicatortomonitor:Allethyleneoxidesterilizationcycles.說明：使用Attest1264生物指示劑監(jiān)測：1.所有環(huán)氧乙烷滅菌的循環(huán)過程。Contraindications:None.禁忌：無。Warning:Thereisaglassampuleinsidetheplasticvialofthebiologicalindicator.Crushingorexcessivehandlingofthebiologicalindicatorbeforecoolingmaycausetheglassampuletoburst.Wearsafetyglassesandgloveswhenremovingthebiologicalindicatorfromthesterilizer.Wearsafetyglasseswhencrushingthebiologicalindicator.Handlethebiologicalindicatorbythecapwhencrushingandtapping.Donotuseyourfingerstocrushtheglassampule.Donotrollthebiologicalindicatorbetweenfingerstowetthesporestrip.警告：在生物指示劑的塑料瓶里有一個玻璃安瓿。冷卻前生物指示劑的壓破或者過度操作都會引起玻璃安瓿破裂。從滅菌器中移出生物指示劑時，應配戴安全防護眼鏡和手套。當壓破生物指示劑時，應配戴安全防護眼鏡。當壓破和輕敲生物指示劑時，通過握緊帽子進行操作。禁止使用手指破碎玻璃安瓿禁止在手指間搖動生物指示劑，該行為會使狍子帶濕潤。Precautions:DonotusetheAttest1264BiologicalIndicatortomonitor:Steamsterilizationcycles.Dryheat,chemicalvapor,orotherlowtemperaturesterilizationprocess.注意事項：禁止使用Attest1264生物指示劑監(jiān)測：循環(huán)蒸汽滅菌。干燥加熱、化學蒸汽或者其他低溫滅菌過程。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.使用說明：通過指示標簽上的滅菌器、負載數(shù)量和加工日期來鑒別生物培養(yǎng)指示劑。根據(jù)推薦的做法，在適當?shù)臏y試盤或包裝內放置一個生物指示劑。可負載的適當?shù)臏y試盤或包裝包括：包裝伸縮工具，塑料、橡膠、金屬工具和設備。在一個AAMI注射器里的Attest1264生物指示劑容納體系Attest1264生物指示劑置于測試產(chǎn)品最難測的區(qū)域。將全負載的測試盤或包裝放在滅菌最難的區(qū)域，通常是在中心區(qū)域。按常規(guī)處理負載。滅菌后的兩個選擇：A.根據(jù)制造商說明書打開滅菌器柜門；轉移負載到曝氣裝置并取回測試包。（如果使用有曝氣能力的滅菌器，按照制造商指示，在曝氣周期之前打開柜門并拆下測試包。）從測試包拆下生物和化學指示劑。根據(jù)醫(yī)療保健設施政策，將測試包剩余部分返回到曝氣裝置。B.保溫前測試包的曝氣曝氣負載中的與測試包的滅菌時間相同的其他包。在曝氣周期結束時，從測試包拆下生物和化學指示劑。根據(jù)醫(yī)療保健設施政策，處理剩余的測試包部件。檢查生物指示劑標簽上的化學指示劑。顏色變成綠色可確認生物指示劑已經(jīng)過EO滅菌過程。顏色的變化并不能表明此過程已達到無菌。如果化學指示劑不變色，檢查滅菌過程。生物指示劑保溫溫度為37±2°C。Attest保溫箱120伏（北美使用）240伏（國際使用）模型117（14項指標）模型117（14項指標）模型127（28項指標）模型127（28項指標）底層模型130（14個指標）底層模型131（14個指標）A.在金屬塊中的指示劑位置（見圖1）。將該指示劑底部放置在保溫箱的金屬加熱座上，使該指示劑處于約45度的角度。B.將指示劑向后徑直推（見圖2）。這將壓碎其中的安瓿并激活指示劑。當指示劑向后推時，確保蓋子位于金屬塊上方。C.向下按壓已被激活的指示劑，使其穩(wěn)固于金屬加熱區(qū)。（見圖3）。當指示劑向下按壓時，確保蓋子位于金屬塊上方。每天至少培養(yǎng)一個未處理的Attest生物指示劑（陽性對照）。在保溫器中，陽性對照指示劑與所處理指示劑應當是同一制造日期和批號。在陽性對照指示劑的標簽上寫上“C”和日期。在37±2°C破碎并培養(yǎng)陽性對照指示劑。培養(yǎng)陽性對照指示劑的目的是為了確保：正確的培養(yǎng)環(huán)境指示劑的活性（不當?shù)膬Υ姝h(huán)境會對即使在規(guī)定保質期內的指示劑產(chǎn)生不利影響）培養(yǎng)基的功效是促進其快速增長在37±2°C將處理過的生物指示劑以及陽性指示劑培養(yǎng)48小時。培養(yǎng)時間：早期監(jiān)測12小時18小時24小時最終監(jiān)測48小時所處理指示劑呈現(xiàn)黃色，表明細菌增長以及滅菌過程失敗。無顏色改變則表明滅菌過程適當。培養(yǎng)48小時后，最終將得到一個陰性結果。相對于所處理的指示劑，陽性對照指示劑應當呈現(xiàn)黃色變化以表明其有效。記錄所處理指示劑和陽性對照指示劑的結果。一旦首個增長證據(jù)被記錄，即為陽性測試結果。在使用和不使用滅菌器的兩種情況下，反復測試，直到生物指示劑的測試結果為陰性。Dispos