3M 1491 - Attest Rapid Readout Sterilization Biological Indicator Vial Steam 2-1/2 Inch

3M 1491 - Attest Rapid Readout Sterilization Biological Indicator Vial Steam 2-1/2 Inch

3M 1491 Attest Super Rapid Steam Biological Indicator

The 3M Attest Super Rapid Readout Steam Biological Indicator 1491, Blue Cap, 24 minute, monitors 270?/132? and 275?/135?, 3-minute and 10-minute, gravity displacement saturated steam sterilization processes. This FDA-cleared and ISO-compliant biological indicator (BI) for steam sterilization provides a final fluorescent result, read by the 3M AttestAuto-reader 490 or 490M, after 24 minutes.

Get results in just 24 minutes with the 3M Attest Super Rapid Readout Steam Biological Indicator 1491 when used in conjunction with the 3M Attest Auto-reader 490 or 490M. This FDA-cleared and ISO 11138-1:2017 and ISO 11138-3:2017 compliant biological indicator (BI) is specifically designed for rapid and reliable qualification testing and routine monitoring of 270?/132? and 275?/135?, 3-minute and 10-minute, gravity displacement saturated steam sterilization processes.

Using the same technology customers have trusted for years optimized to deliver an even faster result, this self-contained BI consists of a spore carrier with spores of Geobacillus stearothermophilus and a sealed glass ampoule with bacteriological media. The spore carrier and media ampoule are contained in a plastic vial topped with a blue color-coded cap which includes a chemical process indicator on top. When processed, the chemical process indicator turns from pink to light or dark brown. After the steam sterilization process, the BI is activated to join the bacteriological media with the processed spores. It is then incubated in the 3M Attest Auto-reader 490 or 490M for a final fluorescent result at 24 minutes.

The BI label contains a UDI-compliant 2-D barcode that allows users to capture BI GTIN, the use-by date and the lot code using a handheld scanner. To minimize waste, the BI tray, QA Cert, IFU, primary packaging box and label can all be recycled.

Features and Benefits of 3M 1491 Attest Super Rapid Steam Biological Indicator

• Results in just 24 minutes
• Color-coded (blue cap) for quick reference and ease of use
• ISO 11138-1:2017 and ISO 11138-3:2017 compliant
• Monitors 270?/132? and 275?/135?, 3-minute and10-minute, gravity displacement saturated steam sterilization processes
• Compatible with the 3M Attest Auto-reader 490 or 490M
• UDI-compliant 2-D barcode technology to capture BI GTIN, use-by date and lot code with handheld scanner
• Recyclable BI tray, QA Cert, IFU, primary packaging box and label minimizes waste

3M 1491 Attest Super Rapid Steam Biological Indicator Directions for Use

• Identify the 1491 BI by writing the sterilizer, load number, and processing date on the indicator label. Do not place another label or indicator tape on the vial or on the cap.
• Place the 1491 BI in a representative tray configuration as recommended by professional association guidelines or national standards for hospital practice.
• Place the representative tray 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.
• Process the load according to recommended practices.
• After completion of the cycle, take the representative tray out of the sterilizer, and remove the 1491 BI.
• Allow the 1491 BI to cool for 10 minutes prior to activation.
• Check the process indicator on the top of the cap of the 1491 BI. A color change from pink to light brown or darker confirms that the 1491 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.
• To activate the biological indicator, place it in an Attest Biological Indicator Activator. Close and squeeze the activator to close the 1491 BI cap and crush the media ampoule. Then remove the BI and flick it (see pictures at right). Visually verify that media has flowed into the growth chamber at the bottom of the vial. If the media hasnt filled the growth chamber, hold the BI by the cap and flick it until media fills the growth chamber. Place the activated 1491 BI:
• in any well of a 490 or 490H Auto-reader having software version 4.0.0 or greater
• in an incubation well of a 490 Auto-reader having software version less than 4.0.0 which is color-coded blue (i.e., configured to incubate 1491 BIs)
• in any well of a 490M Auto-reader
• and wait for the result. See the Auto-reader Operators Manual for further information related to its use.
• Each day that a processed 1491 BI is incubated, activate and incubate at least one non-processed 1491 BI to use as a positive control. Follow the activation instructions provided in Step 8 above. Write a C (for control) and the date on the BI label. The positive control should be from the same lot code as the processed biological indicator. It is a good practice to use a positive control each day a processed 1491 BI is incubated. This helps confirm:
• correct incubation temperatures are met,
• viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals,
• capability of media to promote rapid growth, and
• proper functioning of the Auto-reader.
• Incubation and Reading: Incubate the positive control and steam processed 1491 BIs in a 490 Auto-reader, a 490H Auto-reader having software version 4.0.0 or greater, or a 490M Auto-reader. See the applicable Auto-reader Operators Manual for the proper use of this equipment. The Auto-reader will indicate a positive result as soon as it is obtained. The final negative 1491 BI reading is made at:
• 24 minutes in 490 or 490H Auto-readers having software version 4.0.0 or greater and in 490M Auto-readers.
• 30 minutes in 490 Auto-readers having software version less than 4.0.0. After the results are displayed and recorded, the 1491 BIs may be discarded.

3M 1491 Attest Super Rapid Steam Biological Indicator Specifications