3MAttest12641264PBiologicalIndicator產(chǎn)品說明書中英文對照Jimizhi

1、3MTM AttestTM 1264/1264PBiological Indicator生物指示劑Product description: The 3M Attest 1264 Biological Indicator (green cap) is designed for monitoring of EO sterilization process.The presence of Bacillus atrophaeus spores is detected by a visual color change (media turns yellow). The yellow color chan

2、ge indicates a sterilization process failure. The final readout of a negative result (media remains green) is made after 48 hours of incubation.產(chǎn)品描述：3M Attest 1264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(jié)果。Monitoring frequency: Attest b

3、iological indicators should be placed in an appropriate test tray or package, and be used to monitor every load. This presents an appropriate challenge and improves the performance of the sterilization process.監(jiān)測頻率：Attest生物指示劑應(yīng)放置在適當?shù)臏y試盤或包裝內(nèi)，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:Use the A

4、ttest 1264 Biological Indicator to monitor:1. All ethylene oxide sterilization cycles.說明：使用Attest 1264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:l There is a glass ampule inside the plastic vial of the biological indicator.l Crushing or excessive handling of the biological indicat

5、or before cooling may cause the glass ampule to burst.l Wear safety glasses and gloves when removing the biological indicator from the sterilizer.l Wear safety glasses when crushing the biological indicator.l Handle the biological indicator by the cap when crushing and tapping.l Do not use your fing

6、ers to crush the glass ampule.l Do not roll the biological indicator between fingers to wet the spore strip.警告：l 在生物指示劑的塑料瓶里有一個玻璃安瓿。l 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。l 從滅菌器中移出生物指示劑時，應(yīng)配戴安全防護眼鏡和手套。l 當壓破生物指示劑時，應(yīng)配戴安全防護眼鏡。l 當壓破和輕敲生物指示劑時，通過握緊帽子進行操作。l 禁止使用手指破碎玻璃安瓿l 禁止在手指間搖動生物指示劑，該行為會使狍子帶濕潤。Precautions:Do not u

7、se the Attest 1264 Biological Indicator to monitor:1. Steam sterilization cycles.2. Dry heat, chemical vapor, or other low temperature sterilization process.注意事項：禁止使用Attest 1264生物指示劑監(jiān)測：1. 循環(huán)蒸汽滅菌。2. 干燥加熱、化學(xué)蒸汽或者其他低溫滅菌過程。Directions for use:1. Identify the Attest biological indicators by writing the ste

8、rilizer, load number, and processing date on the indicator label.2. Place an Attest biological indicator in an appropriate test tray or package according to recommended practices. Appropriate test trays or packages for loads containing:Wrapped telescopic instruments, plastic, rubber, metal instrumen

9、ts, and equipment.l Attest 1264 Biological Indicator in an AAMI syringe pack.Container systemsl Attest 1264 Biological Indicator in the areas determined by product testing to be the most resistant.3. Place the test tray or package in a full load in the most challenging area for the sterilant. This i

10、s generally in the center of the road.4. Process the load as usual.5. After sterilization two options exist:A. Open the sterilizer door according to the manufacturers instructions; transfer the load to the aerator and retrieve the test pack.(If a sterilizer with aeration capability is used, follow t

11、he manufacturers instructions for opening the door and remove the test pack prior to the aeration cycle.)Removethe biological and chemicalindicator from the test pack. Return the remainder of the test pack to the load for aeration according to the healthcare facilitys policy.B. Aeration of test pack

12、 prior to incubationAerate the other packs from the load for the same amount of time as the test pack. At the end of the aeration cycle, remove the biologicaland chemicalindicator from the test pack.Dispose of the remaining test pack components according to the healthcare facilitys policy.6. Check t

13、he chemical indicator on the label of the biological indicator. A color change to green confirms that thebiological indicatorhas been exposed to the EO sterilization process.Thecolor change does not indicate that the process was sufficient to achieve sterility. If the chemical indicator is unchanged

14、, check the sterilization process.7. Incubate the biological indicator at 37 ± 2°C (99 ± 3°F).Attest Incubator120 volt (North American Usage) 240 volt (International Usage)Model 117 (14 indicators) Model 117 (14 indicators)Model 127 (28 indicators) Model 127 (28 indicators)Bottom

15、 tier of Model 130 (14 indicators) Bottom tier of Model 131 (14 indicators)A. Position indicator in metal block (see Figure 1). Place bottom of the indicator into the incubators metal heating block so that the indicator is atan angle of approximately 45°.B. Push the indicator straight back (see

16、 Figure 2). This crushes the media ampule and activates the indicator. Be sure that the cap will remainabove the metal block when the indicator is pushed back.C. Push the activated indicator down to seat it in the metalheating block. (See Figure 3). Be sure that the cap remainsabove the metal block

17、when seated in the incubator.8. Incubate at least one non-processed Attest biological indicator (positive control) each day a processed indicator is incubated. The positive control indicator should be from the same manufacturing date and lot number as the processed indicator in the incubator.9. Writ

18、e a “C” and a date on the label of the positive control indicator. Crush and incubate the control at 37 ± 2°C (99 ± 3°F).The purpose of the positive control is to ensure:l correct incubation conditionsl viability of indicators (incorrect storage conditions could adversely affect

19、even those indicators which are within their stated shelf life)l capability of media to promote rapid growth10. Incubate the processed and control biological indicators for 48 hours at 37 ± 2°C (99 ± 3°F).Incubation times:Early detection 12 hours 18 hours 24 hoursFinal detection

20、48 hoursThe appearance of a yellow color in the processed indicator demonstrates bacterial growth and a sterilization process failure. No color change indicates an adequate sterilization process. A final negative result is made after 48 hours of incubation. The positive control indicator should show

21、 a yellow color change for the processed indicator results to be valid.11. Record the processed and control biological indicator results. Act on any positive test as soon as the first evidence of growth is noted. Always retest the sterilizer and do not use the sterilizer until the biological indicat

22、or test results are negative.使用說明：1. 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。2. 根據(jù)推薦的做法，在適當?shù)臏y試盤或包裝內(nèi)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(shè)備。l 在一個AAMI注射器里的Attest 1264生物指示劑容納體系l Attest 1264生物指示劑置于測試產(chǎn)品最難測的區(qū)域。3. 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。4. 按常規(guī)處理負載。5. 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(zhuǎn)移負載到曝氣裝置并取回測試包。（如果使用有

23、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(xué)指示劑。根據(jù)醫(yī)療保健設(shè)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(jié)束時，從測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，處理剩余的測試包部件。6. 檢查生物指示劑標簽上的化學(xué)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(xué)指示劑不變色，檢查滅菌過程。7. 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

24、）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。8. 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

25、應(yīng)當是同一制造日期和批號。9. 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：l 正確的培養(yǎng)環(huán)境l 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(zhì)期內(nèi)的指示劑產(chǎn)生不利影響）l 培養(yǎng)基的功效是促進其快速增長10. 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(jié)果。相對于所處理的指示劑，陽性對照指示劑應(yīng)當呈現(xiàn)黃色變化以表明其有效。11. 記錄所處理指示劑和陽性對照指示劑的結(jié)果。一旦首個增長證據(jù)被記錄，即為陽性測試結(jié)果。在使用和不使用滅菌器的兩種情況下，反復(fù)測試，直到生物指示劑的測試結(jié)果為陰性。Disposal:Dispose of used Attest biological indicators according to