3M-Attest-1264-1264P-Biological-Indicator-產(chǎn)品說(shuō)明書(shū)(中英文對(duì)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(lái)監(jiān)測(cè)環(huán)氧乙烷滅菌過(guò)程?？赏ㄟ^(guò)視覺(jué)上的顏色變化（培養(yǎng)基變成黃色）來(lái)檢測(cè)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(guò)程失敗；如果培養(yǎng)基保持綠色不變，經(jīng)48小時(shí)潛伏期后，最終得到陰性結(jié)果。Monitoringfrequency:Attestbiologicalindicatorsshouldbeplacedinanappropriatetesttrayorpackage,andbeusedtomonitoreveryload.Thispresentsanappropriatechallengeandimprovestheperformanceofthesterilizationprocess.監(jiān)測(cè)頻率：Attest生物指示劑應(yīng)放置在適當(dāng)?shù)臏y(cè)試盤或包裝內(nèi)，以便監(jiān)測(cè)每一個(gè)負(fù)載。此方法對(duì)滅菌過(guò)程來(lái)說(shuō)是一個(gè)挑戰(zhàn)，它提高了滅菌過(guò)程的成效。Indications:UsetheAttest1264BiologicalIndicatortomonitor:Allethyleneoxidesterilizationcycles.說(shuō)明：使用Attest1264生物指示劑監(jiān)測(cè)：1.所有環(huán)氧乙烷滅菌的循環(huán)過(guò)程。Contraindications:None.禁忌：無(wú)。Warning:Thereisaglassampuleinsidetheplasticvialofthebiologicalindicator.Crushingorexcessivehandlingofthebiologicalindicatorbeforecoolingmaycausetheglassampuletoburst.Wearsafetyglassesandgloveswhenremovingthebiologicalindicatorfromthesterilizer.Wearsafetyglasseswhencrushingthebiologicalindicator.Handlethebiologicalindicatorbythecapwhencrushingandtapping.Donotuseyourfingerstocrushtheglassampule.Donotrollthebiologicalindicatorbetweenfingerstowetthesporestrip.警告：在生物指示劑的塑料瓶里有一個(gè)玻璃安瓿。冷卻前生物指示劑的壓破或者過(guò)度操作都會(huì)引起玻璃安瓿破裂。從滅菌器中移出生物指示劑時(shí)，應(yīng)配戴安全防護(hù)眼鏡和手套。當(dāng)壓破生物指示劑時(shí)，應(yīng)配戴安全防護(hù)眼鏡。當(dāng)壓破和輕敲生物指示劑時(shí)，通過(guò)握緊帽子進(jìn)行操作。禁止使用手指破碎玻璃安瓿禁止在手指間搖動(dòng)生物指示劑，該行為會(huì)使狍子帶濕潤(rùn)。Precautions:DonotusetheAttest1264BiologicalIndicatortomonitor:Steamsterilizationcycles.Dryheat,chemicalvapor,orotherlowtemperaturesterilizationprocess.注意事項(xiàng)：禁止使用Attest1264生物指示劑監(jiān)測(cè)：循環(huán)蒸汽滅菌。干燥加熱、化學(xué)蒸汽或者其他低溫滅菌過(guò)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(shuō)明：通過(guò)指示標(biāo)簽上的滅菌器、負(fù)載數(shù)量和加工日期來(lái)鑒別生物培養(yǎng)指示劑。根據(jù)推薦的做法，在適當(dāng)?shù)臏y(cè)試盤或包裝內(nèi)放置一個(gè)生物指示劑?？韶?fù)載的適當(dāng)?shù)臏y(cè)試盤或包裝包括：包裝伸縮工具，塑料、橡膠、金屬工具和設(shè)備。在一個(gè)AAMI注射器里的Attest1264生物指示劑容納體系A(chǔ)ttest1264生物指示劑置于測(cè)試產(chǎn)品最難測(cè)的區(qū)域。將全負(fù)載的測(cè)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(fù)載。滅菌后的兩個(gè)選擇：A.根據(jù)制造商說(shuō)明書(shū)打開(kāi)滅菌器柜門；轉(zhuǎn)移負(fù)載到曝氣裝置并取回測(cè)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(kāi)柜門并拆下測(cè)試包。）從測(cè)試包拆下生物和化學(xué)指示劑。根據(jù)醫(yī)療保健設(shè)施政策，將測(cè)試包剩余部分返回到曝氣裝置。B.保溫前測(cè)試包的曝氣曝氣負(fù)載中的與測(cè)試包的滅菌時(shí)間相同的其他包。在曝氣周期結(jié)束時(shí)，從測(cè)試包拆下生物和化學(xué)指示劑。根據(jù)醫(yī)療保健設(shè)施政策，處理剩余的測(cè)試包部件。檢查生物指示劑標(biāo)簽上的化學(xué)指示劑。顏色變成綠色可確認(rèn)生物指示劑已經(jīng)過(guò)EO滅菌過(guò)程。顏色的變化并不能表明此過(guò)程已達(dá)到無(wú)菌。如果化學(xué)指示劑不變色，檢查滅菌過(guò)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(guó)際使用）模型117（14項(xiàng)指標(biāo)）模型117（14項(xiàng)指標(biāo)）模型127（28項(xiàng)指標(biāo)）模型127（28項(xiàng)指標(biāo)）底層模型130（14個(gè)指標(biāo)）底層模型131（14個(gè)指標(biāo)）A.在金屬塊中的指示劑位置（見(jiàn)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(jiàn)圖2）。這將壓碎其中的安瓿并激活指示劑。當(dāng)指示劑向后推時(shí)，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(jiàn)圖3）。當(dāng)指示劑向下按壓時(shí)，確保蓋子位于金屬塊上方。每天至少培養(yǎng)一個(gè)未處理的Attest生物指示劑（陽(yáng)性對(duì)照）。在保溫器中，陽(yáng)性對(duì)照指示劑與所處理指示劑應(yīng)當(dāng)是同一制造日期和批號(hào)。在陽(yáng)性對(duì)照指示劑的標(biāo)簽上寫上“C”和日期。在37±2°C破碎并培養(yǎng)陽(yáng)性對(duì)照指示劑。培養(yǎng)陽(yáng)性對(duì)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(dāng)?shù)膬?chǔ)存環(huán)境會(huì)對(duì)即使在規(guī)定保質(zhì)期內(nèi)的指示劑產(chǎn)生不利影響）培養(yǎng)基的功效是促進(jìn)其快速增長(zhǎng)在37±2°C將處理過(guò)的生物指示劑以及陽(yáng)性指示劑培養(yǎng)48小時(shí)。培養(yǎng)時(shí)間：早期監(jiān)測(cè)12小時(shí)18小時(shí)24小時(shí)最終監(jiān)測(cè)48小時(shí)所處理指示劑呈現(xiàn)黃色，表明細(xì)菌增長(zhǎng)以及滅菌過(guò)程失敗。無(wú)顏色改變則表明滅菌過(guò)程適當(dāng)。培養(yǎng)48小時(shí)后，最終將得到一個(gè)陰性結(jié)果。相對(duì)于所處理的指示劑，陽(yáng)性對(duì)照指示劑應(yīng)當(dāng)呈現(xiàn)黃色變化以表明其有效。記錄所處理指示劑和陽(yáng)性對(duì)照指示劑的結(jié)果。一旦首個(gè)增長(zhǎng)證據(jù)被記錄，即為陽(yáng)性測(cè)試結(jié)果。在使用和不使用滅菌器的兩種情況下，反復(fù)測(cè)試，直到生物指示劑的測(cè)試結(jié)果為陰性。Dispos