3M Attest 1492V - Indications for Use; Safety Information; Directions for Use

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Indications forUse
UnitedStates
Use the 3M™Attest™ Super Rapid Readout Biological Indicator 1492V in
conjunction with both the 3M™Attest™ Auto-reader 490or the Attest™
Auto-reader 490H having software version 4.0.0or greater to qualify or monitor
dynamic-air-removal steam sterilization cycles of:
• 3minutes at 270°F (132°C)
• 4minutes at 270°F (132°C)
• 3minutes at 275°F (135°C).
Outside the UnitedStates
Use the 3M™Attest™ Super Rapid Readout Biological Indicator 1492V in
conjunction with the 3M™Attest™ Auto-reader 490or Attest™ Auto-reader 490H
having software version 4.0.0or greater to qualify or monitor 270°F (132°C) to
275°F (135°C) dynamic-air-removal steam sterilization cycles.
Contraindications
None.
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°F (121°C) dynamic-air-removal steam sterilization cycles;
c. Dry heat, chemical vapor, ethylene oxide or other low temperature
sterilization processes.
2. To reduce the risk associated with incorrect results:
• Do not place tape or labels on 1492VBI prior to sterilization or incubation.
• Do not incubate a 1492VBI if, after processing and before BI activation, it
is observed to have a broken media ampoule. Retest the sterilizer with a
new biological indicator.
• After processing, allow BI to cool for 10minutes before incubation.
• After BI activation, ensure media has flowed to the spore growth chamber.
Monitoring Frequency
Follow facility Policies and Procedures which should specify a biological indicator
monitoring frequency compliant with professional association recommended
practices and/or national guidelines and standards. 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 1492VBI 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 1492VBI 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 1492VBI
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 1492VBI.
6. Allow the 1492VBI to cool for 10minutes prior to activation.
7. Check the process indicator on the top of the cap of the 1492VBI. 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.