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3MTm AttestTM <br />41382/41382F <br />Rapid 5 Steam -Plus Test Pack <br />team <br />3MTM AttestTM 1292 Rapid Readout Biological Indicator: <br />Meets ANSVAAMIAS011138-1:2006 and ANSVAAMI/iS011138-3:2006 and <br />EN/IS011138-1:2006 and EN/15011138-3:2006. <br />3MTM ComplyTM SteriGageTM 1243 Steam Chemical integrator. <br />Meets Class 5 Integrating indicator classification perANSI/AAMIAS011140-1:2005 and <br />EN/ ISO 11140-1:2005. <br />LO7 <br />The lot in a box and the hourglass symbols represent expiration date and <br />lot number. The hourglass is followed by a year and month that represent <br />the expiration date (year and month: 2013-12). All of the information to <br />the right of the hourglass symbol represents the lot number (2013-12 AZ). <br />Product Descriptiorr <br />The 3MTM AttestTM 41382 Rapid 5 Steam -Plus Test Pack is specifically designed to <br />routinely challenge the steam sterilization process in healthcare facilities. This convenient <br />disposable process challenge device presents a challenge to the sterilization process <br />equivalent to the biological Indicator 16 towel process challenge device (BI PCD) <br />recommended byAAMI. Each test pack contains a process indicator on the outside that <br />changes from yellow to dark brown when steam processed. <br />Each pack contains a 3MTM AttestTm 1292 Rapid Readout Biological indicator (brown <br />cap), a record keeping sheet, and a 3MTM ComplyTM SteriGageTM 1243 Steam Chemical <br />Integrator. Attest biological indicator controls are provided. When steam processed the <br />chemical indicator on the Attest via[ label chahges color from rose to brown. <br />The Comply SteriGage 1243 Steam Chemical Integrator consists of a paper wick and <br />steam temperature sensitive chemical pellet contained in a paper/film/foil laminate. When <br />exposed to steam sterilization conditions, the chemical pellet melts and migrates as a dark <br />color along the paper wick. The migration Is visible through a window marked REJECT or <br />ACCEPT. The extent of migration depends on steam, time, and temperature. <br />The Attest 1292 Rapid Readout Biological Indicator Is a dual readout biological Indicator <br />system specifically designed for rapid and reliable monitoring of the steam sterilization <br />process when used in conjunction with the 3MTM AttestTM 290 Auto -reader. <br />The Attest 1292 Rapid Readout Biological indicator detects the presence of viable <br />Geobacillus stearothermophitus spores by detecting the activity of alpha -glucosidase, an <br />enzyme present within the organism. The presence of the enzyme is detected by reading <br />fluorescence produced by the enzymatic breakdown of a non -fluorescent substrate. <br />This creates a fluorescence change, which is detected by the Attest 290 Auto -reader. A <br />fluorescence change indicates a steam sterilization process failure. <br />The Attest 1292 Rapid Readout Biological Indicator also detects the presence of G. <br />slearothermophilus organisms by a visual color change reaction. Biochemical activity <br />of the G. stearothemtophilus organism produces acid by-products that cause the media <br />to channe cnlor from nurole to vellnw. A visual aH color chane also indicates a sfPam <br />