3MAttest12641264PBiologicalIndicator产品说明书中英文对照Jimizhi

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1、3MTM AttestTM 1264/1264PBiological Indicator生物指示剂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.产品描述：3M Attest 1264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。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.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:Use the A

4、ttest 1264 Biological Indicator to monitor:1. All ethylene oxide sterilization cycles.说明：使用Attest 1264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: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 在生物指示剂的塑料瓶里有一个玻璃安瓿。l 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。l 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。l 当压破生物指示剂时，应配戴安全防护眼镜。l 当压破和轻敲生物指示剂时，通过握紧帽子进行操作。l 禁止使用手指破碎玻璃安瓿l 禁止在手指间摇动生物指示剂，该行为会使狍子带湿润。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.注意事项：禁止使用Attest 1264生物指示剂监测：1. 循环蒸汽灭菌。2. 干燥加热、化学蒸汽或者其他低温灭菌过程。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 2C (99 3F).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 tier of Model 130 (14 ind

15、icators) 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 Figure 2). This crushes the med

16、ia 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 when seated in the incubator.8.

17、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. Write a “C” and a date on the label

18、of the positive control indicator. Crush and incubate the control at 37 2C (99 3F).The purpose of the positive control is to ensure:l correct incubation conditionsl viability of indicators (incorrect storage conditions could adversely affect even those indicators which are within their stated shelf

19、life)l capability of media to promote rapid growth10. Incubate the processed and control biological indicators for 48 hours at 37 2C (99 3F).Incubation times:Early detection 12 hours 18 hours 24 hoursFinal detection 48 hoursThe appearance of a yellow color in the processed indicator demonstrates bac

20、terial 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 a yellow color change for the processed indicator results to be valid.11. Record th

21、e 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 indicator test results are negative.使用说明：1. 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。2. 根据推荐的做法，在适当的

22、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。l 在一个AAMI注射器里的Attest 1264生物指示剂容纳体系l Attest 1264生物指示剂置于测试产品最难测的区域。3. 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。4. 按常规处理负载。5. 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

23、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。6. 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。7. 生物指示剂保温温度为37 2C。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

24、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。8. 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。9. 在阳性对照指示剂的标签上写上 “C”和日期。在372C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：l 正确的培养环境l 指示剂的活性（不当的储存

25、环境会对即使在规定保质期内的指示剂产生不利影响）l 培养基的功效是促进其快速增长10. 在372C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。11. 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。Disposal:Dispose

26、 of used Attest biological indicators according to your healthcare facilitys policy. You may wish to autoclave any positive biological indicators at 250F/121C for at least15 minutes, or at 270F/132C for 10 minutes in a gravity displacement steam sterilizer, or at 270F/132C for 4 minutes in a vacuum

27、assisted steam sterilizer.处理：根据你方医疗保健设施政策，处理使用过的Attest生物指示剂。可采用高温蒸汽灭菌器处理阳性生物指示剂，处理温度121C，时间至少15分钟。或者采用重力置换蒸汽灭菌器，处理温度121C，时间10分钟。或者采用真空蒸汽灭菌器，处理温度为132C，时间4分钟。Storage and Shelf Life:A. Store Attest biological indicators under normal room conditions: 59-86F (15-30C), 35-60% relative humidity.B. Do not store these biological indicators near sterilants or other chemicals.C. Attest biological indicators have a 24 month shelf life.储存和保质期：A. 应在正常室内条件下储存Attest生物指示剂： 15-30C，相对湿度35-60%。B. 禁止在消毒剂或者其他化学药品附近储存该生物指示剂。C. Attest生物指示剂保质期为24个月。5