3m attest steam incubator manual
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3m attest steam incubator manualLeave us your number and we'll give you advice for free. In this way you can quickly respond to failures in the sterilisation system. More than 2 000 dental clinics already rely on us. Create one here. Creators are allowed to post content they produce to the platform, so long as they comply with our policies. United Kingdom. Company number 10637289. All related items caused by this demand are Non-Returnable.Biological indicators provide the best assurance of sterility by challenging the sterilizer with quantifiable, highly resistant spores. Gives clear, easy to interpret readout of the effectiveness of the sterilization process with results in 48 hours. With one of the largest catalogs of medical, surgical and diagnostic supplies available online, Medex Supply can accommodate your facility's needs for Surgical Supplies. Sterilization Tests can be found in our extensive online collection of products from globally recognized and trusted brands, including 3M. An excellent option to consider is the Attest Monitoring Starter Kit. Reduced incubation time with Attest biological indicator products can improve inventory levels and increase turns.Learn more. Pour une meilleure experience web, prenez le temps de mettre votre navigateur a jour. The wait time to speak to one of our customer service representatives will be longer than usual. All other inquiries regarding deliveries or product information will be handled as soon as possible. Consequently, we cannot guarantee the usual delivery times. ETA for delivery will take longer than the regular ETA. For use in every load ofEasily and accuratelyUse to consolidate all sterilization process data into an easily accessible database. Regular compliance. After sterilization, the vial is ''crushed'' to join the growth media with the processed spore strip. The BI is incubated for 48 hours for a visual change readout. A color change to yellow indicates surviving spores and a positive result.http://mestan.by/images/3m-s-63-manual-box-sealer.xml
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We also use cookies to collect information for making reports and to help us improve the site. The cookies collect information in an anonymous form. The safe handling of category A infectious substances is a unique challenge in this environment. One solution is on-site waste treatment with a steam sterilizer or autoclave. The Johns Hopkins Hospital (JHH) installed two pass-through autoclaves in its biocontainment unit (BCU). The JHH BCU and The Johns Hopkins biosafety level 3 (BSL-3) clinical microbiology laboratory designed and validated waste-handling protocols with simulated patient trash to ensure adequate sterilization. The results of the validation process revealed that autoclave factory default settings are potentially ineffective for certain types of medical waste and highlighted the critical role of waste packaging in successful sterilization. The lessons learned from the JHH validation process can inform the design of waste management protocols to ensure effective treatment of highly infectious medical waste. INTRODUCTION The Ebola outbreak in West Africa in 2014 revealed potential gaps in the abilities of U.S. hospitals to safely provide care for patients with highly infectious diseases. In response to the crisis, the Centers for Disease Control and Prevention (CDC) recommended a tiered approach wherein U.S. hospitals serve as frontline health care facilities, Ebola assessment hospitals, or Ebola treatment centers (ETCs) ( 4 ). The Office of the Assistant Secretary for Preparedness and Response (ASPR), a federal office in the Department of Health and Human Services (HHS), created a regional response plan, which called for the creation of Regional Ebola and Other Special Pathogen Treatment Centers (RETCs) ( 5 ). These RETCs were modeled in part on the U.S.http://estudiantes.us.es/sites/default/files/ficheros/3m-soundpro-manual.xml facilities that provided care for Ebola patients, namely the University of Nebraska Medical Center, the National Institutes of Health, Emory University, and Bellevue Hospital Center, and also include design elements based on local capabilities and lessons learned from the outbreak ( 6 ). A category A infectious substance is “capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs” ( 12 ). Only a small number of civilian facilities process category A substances, and the cost and logistical barriers to transporting waste to those facilities are substantial. The amount of waste generated during the care of an Ebola patient is also significantly greater than that for routine medical care. Medical waste that is treated onsite through the use of steam sterilizers, or autoclaves, can be handled as regulated medical waste ( 9 ). The CDC and ASPR recommend that facilities preparing to care for patients infected with Ebola consider installing on-site autoclaves to handle category A infectious substances ( 7 ). The Johns Hopkins Hospital (JHH) BCU is the ASPR region 3 RETC serving Maryland, Delaware, Pennsylvania, Virginia, West Virginia, and Washington, DC ( 5 ). The JHH BCU includes two pass-through autoclaves for treating infectious waste prior to transporting it off the unit ( 6 ). A preliminary risk assessment (PRA) was conducted to identify potential high-consequence events during autoclave use and to offer opportunities for risk reduction. The PRA identified the following two main risks associated with waste disposal and autoclave use: (i) the exposure of a health care worker to infectious material, and (ii) the failure to effectively sterilize waste. To address the risk of sterilization failure, the JHH BCU conducted a series of validation experiments using mock patient care trash loads.http://www.drupalitalia.org/node/67013 These experiments demonstrated that autoclave factory default settings are potentially inadequate for sterilizing highly infectious waste and that careful attention to waste packaging prior to autoclave processing is a critical factor for successful sterilization. The lessons learned from this validation process can inform waste management protocols to ensure effective treatment of highly infectious medical waste at facilities that utilize on-site autoclaves. RESULTS We found that 16 of 19 (84) autoclave cycles performed using factory default settings failed to sterilize the biological indicators in the center of the load. These failed runs contained simulated loads composed of liquids (0.5 to 1 liter) in suction canisters or sharps containers, as well as PPE and other paper products. Water-saturated and unsaturated bed linens (blankets, sheets, and pillow cases) treated with a vacuum cycle for 15 min or with either of the other two default cycles (liquid or gravity) for 30 min also failed to be sterilized. Failure to sterilize the biological indicators occurred regardless of the type of bag closure used, including those that were goose-necked and secured lightly with autoclave tape or were just lightly folded and placed in the autoclave tray. The autoclave service contractor (Modular Component Systems, LLC, Stevensville, MD) was notified of these failures and confirmed that each autoclave was operating within manufacturer specifications. These runs on simulated loads were repeated multiple times with various sterilization cycle parameters. Initially, attempts were made to identify a single cycle type (liquid, gravity, or vacuum) that would work well for all waste packaged together, as the sorting of trash by type may be too great a safety risk. Repeated runs using a liquid cycle for 60 or 120 min with goose-necked, double, or triple autoclave bags failed, regardless of cycle type.http://arredomilano.com/images/3m-c1060-installation-manual.pdf In fact, all runs conducted in which any of the bags were goose-necked or tightly sealed failed. All runs in which a solidifier was used failed. Dissolvable autoclave bags began to break apart within 1 min after coming into contact with moist or wet materials, such as bed linens, so they were not tested in the autoclave. Hg (inches of mercury), and 3 prevacuum pulses. Nine of nine runs (100) containing multiple saturated linens and using a shorter sterilizing time (3 runs each of 15, 30, and 45 min) failed. For safety, the optimal closure for the outer bag was a 2-in.The optimized parameters are summarized in Table 1. View this table: View inline View popup TABLE 1 Optimized cycles and parameters used in this study for adequate sterilization of simulated waste Since initiating the use of the optimized parameters, we have completed two consecutive quarterly validations of the autoclave system. We found that 18 of 18 (100) mock patient loads (6 PPE, 6 linen, and 6 liquid loads) passed with the optimized parameters compared to only 3 of 19 (16) mock loads that passed with use of the factory default settings. DISCUSSION Current protocols for sterilizing waste from patients with serious communicable diseases, such as Ebola, are based on guidelines for biosafety levels (BSLs) 3 and 4 laboratories ( 13 ). While these protocols have been developed to enhance laboratory safety in the handling of infectious materials, they may not be adequate for the type and volume of waste generated from patient care activities. The validation process of the JHH waste-handling system identified several critical issues that need to be considered in the design of protocols for sterilizing waste generated from the care of patients with highly infectious diseases, such as Ebola. First and foremost, the JHH experience highlighted the need to validate waste management protocols using simulated patient care loads. The simulated loads need to reflect the expected volume and type of waste that will be generated from a patient with a particular disease, and they need to feature the materials that will be used in patient care, including the same autoclave bags, personal protective equipment (PPE), linens, and liquid waste containers. The validation cycles with simulated waste must be processed with biological indicators buried within the trash load, since indicators outside the autoclave bag may not accurately reflect the conditions inside the bag during the autoclave cycle. Based on the validation results, individual facilities may need to reassess the use of particular patient care items. For example, the JHH BCU no longer uses heavy cotton blankets in patient care rooms, since heavy linens saturated with water were the most likely to fail the validation protocol, even at the highest settings of pressure and temperature. This validation process led to several important changes in the JHH BCU protocols for the packaging of in-room waste. Providers will never reach into trash containers to re-sort waste once it has been discarded. If waste types are inadvertently packaged together, the entire load will be run on the liquid cycle to ensure adequate sterilization. The reason that all loads are not run on the liquid cycle is that this cycle takes 2 to 4 times as long as the other available cycles. It would be challenging to sterilize the anticipated large amounts of waste from an Ebola patient if each cycle took 2 h to complete. The tradeoff for this is the extra step of separating waste in the patient's room. One of the most important findings of this study is that autoclave bags should not be sealed prior to treatment, so as to allow steam to penetrate into the center of the bag. Despite testing many different types of closures, we found that biological indicators in the center of a load are not sterilized unless there is an opening in both the inner and the outer autoclave bags. This point is critical, since within-bag biological indicators were not adequately sterilized even in loosely taped autoclave bags, especially those with tightly packed loads or those containing saturated linens. Individual facilities will need to develop their own protocols to safely transport waste from the site of patient care to the autoclave, being careful to not load sealed bags into the autoclave. For example, at JHH, a metal clamp is used to close the outer autoclave bag for transport, and the clamp is then removed and placed in the autoclave tray just prior to placing the load into the autoclave. After autoclaving, the sterilized clamp can be reused. Indicators placed in solidified liquids did not pass the validation process regardless of the autoclave parameters used or the type of cycle selected. This raises potential safety concerns, since currently, there is a paucity of data regarding the use of solidifying agents in the care of patients with highly infectious diseases. Further investigation is warranted, as large volumes of highly infectious liquid waste are likely to be encountered with Ebola patients as well as those with other diseases. Current JHH BCU patient care protocols do not utilize solidifying agents. Finally, autoclaves need to be operated and tested on a regular basis to ensure that they achieve the proper temperature and pressure parameters before being used for patient care. At JHH, each autoclave is operated four times per week in accordance with manufacturer's recommendations. Quarterly validation of each autoclave cycle is conducted using the three types of simulated trash loads and biological indicators. If changes are made to waste-handling protocols or new equipment is used in patient care, the validation process is repeated to ensure adequate treatment of patient care waste. Detailed logs of all weekly and quarterly validation runs are maintained, and preventive maintenance is conducted on an annual basis. It is also important that autoclave settings for all load types be reviewed following preventive maintenance or other repairs, as settings may inadvertently be reset to factory defaults, which would result in run failure. For this reason, all optimized autoclave settings should be recorded should the need to reinstall them arise. Conclusions. The sterilization of waste containing category A infectious substances using steam sterilizers, or autoclaves, has been adopted by a number of hospitals preparing to care for patients with Ebola and other serious communicable diseases. While autoclave sterilization may be an effective and safe way to process infectious waste for transport and disposal, this study shows that factory default settings and laboratory waste guidelines are likely insufficient to adequately sterilize pathogens in the center of medical waste autoclave loads. Autoclave parameters may need to be adjusted, with particular attention paid to the way that waste loads are packaged prior to treatment. Each facility utilizing autoclaves for the treatment of infectious medical waste should validate their waste management protocols with simulated patient trash loads and within-bag biological indicators to ensure that waste is properly decontaminated. MATERIALS AND METHODS Design of the JHH waste-handling system. To facilitate the unidirectional flow of waste through the unit, the JHH BCU installed two pass-through steam sterilizers (PSS-500, software version 7923; Primus Sterilizer Co., Omaha, NE). Waste is transported in sealed containers from patient care areas to a special waste-handling room at the far end of the unit. Contaminated waste is loaded on the unit side, and once treated, is unloaded on the clean side and packaged for transport and disposal. The autoclaves have a special “Bioseal” function, which allows biological separation of the clean and dirty sides. When the autoclave cycle is completed, the door gasket on the clean side retracts, while the gasket on the dirty side remains sealed. The doors cannot be opened simultaneously, which prevents cross-contamination of the autoclave's clean and dirty sides. Each autoclave is a stand-alone unit, which allows for continued operation of one autoclave if the other unit requires maintenance. Steam intake and electrical and mechanical infrastructures are located on the clean side of the waste-handling area to facilitate autoclave maintenance even while the BCU is caring for a patient. The entire system is connected to the hospital's backup power system, which has two substations and enough backup fuel to maintain power for up to 90 h in the event of a citywide loss of electricity ( 6 ). Autoclave validation process. The BCU team partnered with experts in The Johns Hopkins Hospital biosafety level 3 (BSL-3) laboratory in the division of medical microbiology to design and test autoclave sterilization protocols. The BSL-3 lab uses an autoclave to sterilize laboratory waste in accordance with current federal guidelines from the CDC, NIH, and HHS ( 13 ). The BCU autoclaves were validated using simulated loads consistent in quantity and composition with items expected from patient rooms in the BCU. These items included unsaturated (dry) and saturated (soaked with at least 1 liter of water) linens (cotton blankets, sheets, and pillow cases), personal protective equipment (PPE), such as gowns, gloves, booties, and hoods, dry trash (paper and plastic products, etc.), and liquids (0.1 to 1 liter), including suction canisters and laboratory sharps containers. A solidifying agent (MediChoice fluid solidifier; Owens and Minor, Mechanicsville, VA) was tested to determine if liquids were effectively treated after the conversion to a solid state. The loads were double or triple bagged, and each bag was filled to 50 to 75 of capacity. The bags were secured using the following variety of closures: a goose-necked closure, with and without autoclave tape; a lightly folded closure, with and without autoclave tape; a rubber-banded closure; and a clamped closure. Different combinations of closures for inner and outer bags were tested. For example, a lightly folded inner bag was tested with a rubber-banded outer bag. Three separate biological indicators were used to test each load. A rapid biological indicator (3M Attest 1292; 3M, St. Paul, MN) and a standard biological indicator (3M Attest 1262) were placed into the center of each load (or directly into liquids) and affixed by a string to the outside of the bags for easy retrieval after autoclaving. This test pack served as a control to ensure that the autoclave cycle was sufficient to sterilize a biological indicator that was not buried inside a waste load. Nonautoclaved rapid and standard biological indicators were used as positive controls for all of the runs. The lot numbers for all biological indicators were recorded to ensure that test indicators and controls were obtained from the same lot. Autoclave cycle types and sterilizations parameters. Liquid, gravity, and vacuum cycles were used depending on the type of load to be sterilized. The individual cycle parameters modified from factory default settings that were tested are shown in Table 3. The modifications included presterilization steps, such as the time spent removing air from the chamber (purge time), the pressure achieved during the charge portion of all prevacuum phases relative to atmospheric pressure (precharge), the vacuum endpoint in in. Hg for all pulses (prevacuum endpoint), and the number of prevacuum pulses. The sterilization parameters included temperature, cycle length, type of exhaust, and dry time. Forty-two different load-run configurations were tested, including unique cycle programs developed as a result of this study. View this table: View inline View popup TABLE 2 Initial factory default cycles and parameters tested View this table: View inline View popup TABLE 3 Autoclave cycles and parameters modified from factory default settings and tested in this study ACKNOWLEDGMENTS We would like to thank the National Ebola Treatment and Education Center (NETEC), as well as our colleagues at Emory University, the University of Nebraska Medical Center, Bellevue Hospital, and the NIH for their assistance in developing and validating our sterilization protocols. We would also like to thank our colleagues at Modular Component Systems, LLC (Stevensville, MD) for assisting us with setting up and maintaining our autoclaves. This work was supported by the Office of the Assistant Secretary for Preparedness and Response, Hospital Preparedness Program (HPP) Ebola Preparedness and Response Activities (no. U3R2015002863). The authors have no conflict of interest to report. FOOTNOTES Received 25 October 2016. Returned for modification 17 November 2016. Accepted 28 November 2016. Accepted manuscript posted online 7 December 2016.The Johns Hopkins medicine experience. Centers for Disease Control and Prevention, Atlanta, GA.. Accessed 1 September 2016. 8. ? Anonymous. 2014. Safe handling, treatment, transport and disposal of Ebola-contaminated waste. Occupational Safety and Health Administration, Washington, DC.. 9. ? Lowe JJ, Olinger PL, Gibbs SG, Rengarajan K, Beam EL, Boulter KC, Schwedhelm MM, Hayes AK, Kratochvil CJ, Vanairsdale S, Frislie B, Lewis J, Hewlett AL, Smith PW, Gartland B, Ribner BS. 2015. Environmental infection control considerations for Ebola.NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. We do not retain these email addresses. They give you even3M Attest Auto-reader 390 for Steam. Auto reader for use with 3M Attest Rapid Readout Biological Indicators and Process Challenge Packs for Steam. 290 Auto-reader. Operator’s Manual. Manual Incubadora Attest 290 Instructions Read and understand all safety information before using this product. There are no user serviceable parts.Summary of Contents of user manual for 3M 390G. Manual Incubadora Attest 290 2016 An item that has been used previously. The item may have some signs of cosmetic wear, but is fully operational and functions as intended. This item may be a floor model or store return that has been used. See the seller’s listing for full details and description of any imperfections.Seller Notes:“ This incubator is in great cosmetic condition. It was tested and in working order. That’s exactly what we do best. LetThe spore carrier and media ampoule are contained in a plastic vial topped with a brown cap. A chemical process indicator which changes from pink to light brown or darker upon exposure to steam is located on the top of the cap. The a-glucosidase in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate, 4-methylumbelliferyl-a-D-gl ucoside (MUG). The resultant fluorescent by-product, 4-methylumbelliferone (MU), is detected in the 490 Auto-reader. The presence of fluorescence within 1 hour of incubation of the 1492V BI in the 490 Auto-reader indicates a steam sterilization process failure. The 1492V BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. Biochemical activity of the G. stearothermophilus organism produces metabolic by-products that cause the media to change color from purple to yellow which also indicates a steam sterilization process failure. Use of this indication method is optional and is typically restricted to special studies. Know Sooner. Because every minute matters. Get biological results in record time with Attest Super Rapid Readout Biological Indicators (BIs) and put your instrument turnaround speed into overdrive. The Attest Super Rapid Readout Advantage Know for Sure. Trusted technology, now optimized. 3M Attest Super Rapid Readout Biological Indicators use the same technology youve trusted for years, now optimized to deliver an even faster result. Meets ISO and FDA requirements. Attest Super Rapid Readout BIs meet the performance requirements of ISO 11138-1:2006 and ISO 11138-3:2006, and satisfy FDA requirements for Biological Indicators. A direct measure of lethality. If the spores are inactivated or killed by the sterilization cycle, you have a direct measure of an effective sterilization process. No other sterilization monitoring device offers you this confidence. No added enzymes. Attest Super Rapid Readout BIs do not contain any added enzymes. The indicators use an enzyme present within the organism and generated during spore activation and outgrowth to provide you with Super Rapid results in an actionable time frame. With a faster BI result, the need for emergency release is reduced, which can lead to improved patient safety. A faster BI result can also result in less emergency release documentation..control costs Faster BI results can result in increased set turnaround and utilization, which can reduce the need to purchase additional sets to have on hand. Faster BI results can also reduce the need for additional loaner and consignment sets, reducing the indirect costs associated with managing those sets..improve OR metrics When you have a faster BI result, turnaround speed can improve, which helps get implants and instruments to the OR faster. That speed can lead to better start-time accuracy, case duration rates, and room turnover rates..improve both surgeon and patient satisfaction When surgeons get what they need, when they need it, that responsiveness can lead to improved surgeon satisfaction. When properly sterilized implants get to the OR on time, surgeries are more likely to proceed without delay, which can lead to better patient outcomes and higher patient satisfaction..lower risk and severity of recalls Should a recall ever occur due to a sterilizer failure, having a faster BI result can help you respond faster, lessening the severity of the recall..improve YOUR peace of mind When implants are only released after the BI result is known, it brings peace of mind. When the OR gets what they need, when they need it, it brings peace of mind. When surveyor visits go smoothly because there are fewer emergency release forms on file, it brings peace of mind. Processed indicators were examined at 48 hours and 7 days for detection of a visual pH color change. Warnings There is a glass ampoule inside the plastic vial of the biological indicator (BI). To avoid the risk of serious injury from flying debris due to a ruptured BI: Allow the BI to cool for the recommended time period before activating. Activating or excessive handling of the BI before cooling may cause the glass ampoule to burst. Wear safety glasses and gloves when removing the BI from the sterilizer. Wear safety glasses when activating the BI. Handle the BI by the cap when crushing or flicking. Do not use your fingers to crush the glass ampoule. Precautions 1. DO NOT use the 1492V BI to monitor sterilization cycles which it is not designed to challenge: a. Gravity-displacement steam sterilization cycles; b. 250? (121?) dynamic-air-removal (pre-vacuum) steam sterilization cycles; c. Dry heat, chemical vapor, ethylene oxide or other low temperature sterilization processes. 2. After BI activation, ensure media has flowed to the spore growth chamber. 3. Do not place tape or labels on 1492V BI prior to sterilization or incubation in the 490 Auto-reader. As a best practice and to provide optimal patient safety, 3M recommends that every steam sterilization load be monitored with a biological indicator in an appropriate Process Challenge Device (PCD i.e., BI challenge test pack). Directions for Use 1. Identify the 1492VBI by writing the load number, sterilizer, and processing date on the indicator label. Do not place another label or indicator tape on the vial or on the cap. 2. Place the 1492VBI in a representative tray configuration or Process Challenge Device (PCD) as recommended by professional association guidelines or national standards for healthcare facility practice. Do not place the 1492VBI in direct contact with a chemical indicator as residue could transfer to the biological indicator and affect the result. 3. Place the PCD in the most challenging area of the sterilizer. This is typically on the bottom shelf, over the drain, however, the sterilizer manufacturer should be consulted to identify the area of the chamber least favorable to sterilization. 4. Process the load according to recommended practices. 5. After completion of the cycle take the PCD out of the sterilizer, and remove the 1492VBI. 6. Allow the 1492VBI to cool for 10 minutes prior to activation. 7. Check the process indicator on the top of the cap of the 1492VBI. A color change from pink to light brown or darker confirms that the 1492V BI has been exposed to the steam process. This color change does not indicate that the steam process was sufficient to achieve sterility. If the process indicator is unchanged, check the sterilizer physical monitors. 8. To activate the biological indicator, place it in a 490 Auto-reader incubation well which is color-coded brown (i.e., configured to incubate 1492VBIs). Press the cap of the BI down firmly to close the cap and crush the glass ampoule. Immediately remove the BI and flick it (see picture at right). Visually verify that media has flowed into the growth chamber at the bottom of the vial.