3M 1496V - PACK, CHALLENGE, ATTEST SUP RAPID READOUT, 24/BX

3M Attest Super Rapid Readout Steam Biological Indicator Challenge Pack 1496V/1496VF comes pre-assembled in a white wrap and includes a 3M Attest Super Rapid Readout Steam Biological Indicator, 1492V, Brown Cap, 24 minute, a record-keeping sheet and a chemical process indicator on the pack label for convenience and ease of use. The challenge pack is FDA-cleared, and the biological indicator (BI) is ISO-compliant and must be used with the 3M Attest Auto-reader 490 or 490M.

This convenient, disposable challenge pack is specifically designed for rapid and reliable qualification testing and routine monitoring of 270?/132? 4-minute and 275?/135? 3-minute dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) saturated steam sterilization cycles in healthcare facilities. The pack presents a challenge to the sterilization process equivalent to the user-assembled biological indicator (BI) challenge test pack (16-towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI).

Reference the instructions for usefor the applicable cycles in the U.S.

Features and Benefits of 3M 1496V Attest Super Rapid Steam Biological Indicator Challenge Pack

3M 1496V Attest Super Rapid Steam Biological Indicator Challenge Pack Indications for Use

United States

Use the 3M Attest Super Rapid Readout Steam Challenge Pack 1496V in conjunction with the 3M Attest Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 4 minutes at 270? (132?) and 3 minutes at 275? (135?). The 3M Attest Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.

Outside the United States

Use the 3M Attest Super Rapid Readout Steam Challenge Pack 1496V in conjunction with the 3M Attest Auto-reader 490 to qualify or monitor 270F (132?) to 275? (135?) dynamic-air-removal (pre-vacuum) steam sterilization cycles.

3M 1496V Attest Super Rapid Steam Biological Indicator Challenge Pack Directions for Use

• Place an Attest Super Rapid Readout Steam Challenge Pack 1496V flat, with the label side up, in a full load in the most challenging area for the sterilant to reach. This is generally on the bottom shelf, over the drain. Do not place objects (i.e., another pack) on top of the challenge pack. This will create too great of a challenge for air removal and steam penetration.
• Process the load according to established procedures.
• After completion of the cycle, while wearing heat resistant gloves, retrieve the challenge pack.
• Check to see that the external process indicator on the outside of the challenge pack has changed from yellow to brown or darker. Open the challenge pack and allow the 1492V BI to cool outside the challenge pack for 10 minutes prior to activation.
• Remove the record keeping card from inside the challenge pack. Check the chemical indicator bar on the record keeping card. A color change from yellow to brown or darker confirms the pack has been exposed to the steam process.
• Check the process indicator on the top of the 1492V BI cap. A color change from pink to light brown or darker confirms that the biological indicator 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.
• Identify the processed 1492V BI by writing the sterilizer, load number, and processing date on the indicator label. Do not place another label or indicator tape on the biological indicator.
• For a permanent record, fill out the required information on the record keeping card. Record the 1492V BI result when available.
• Discard the challenge pack. Using the challenge pack more than once will invalidate subsequent test results
• To activate the 1492V BI, place it in a 490 Auto-reader incubation well which is color-coded brown (i.e., configured to incubate 1492V BIs). While wearing safety glasses, 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. If the media hasnt filled the growth chamber, hold the BI by the cap and flick it until media fills the growth chamber. Return the activated 1492V BI to the incubation well and wait for the result. See the 490 Auto-reader Operators Manual for further information related to its use.
• Each day that a processed 1492V BI is incubated, activate and incubate at least one non-processed 1492V BI to use as a positive control. Follow the activation instructions provided in Step 10 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. The positive control BI 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 490 Auto-reader
• Incubation and Reading: Incubate the positive control and steam processed 1492V BIs at 56 2? in a 490 Auto-reader. See the 490 Auto-reader Operators Manual for the proper use of this equipment. Positive 1492V BI results are available within 1 hour. The 490 Auto-reader will display a positive result as soon as it is obtained. The final negative 1492V BI reading is made at 1 hour. After the results are displayed and recorded, the 1492V BIs may be discarded.

3M 1496V Attest Super Rapid Steam Biological Indicator Challenge Pack Specifications