3M Attest 1491 Manual De Instrucciones página 4

Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction
with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H
having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader
490M to monitor the cycles below.
Sterilization Type
Gravity Displacement
Steam Sterilization Cycle
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, flicking, or tapping.
• Do not use your fingers to crush the glass ampoule.
Precautions
1. DO NOT use the 1491 BI to monitor sterilization cycles which it is not designed
to challenge:
• 275°F (135°C), 270°F (132°C) and/or 250°F (121°C) dynamic-air-removal
steam sterilization cycles.
• 250°F (121°C) gravity-displacement steam sterilization cycles.
• Dry heat, chemical vapor, ethylene oxide or other low temperature
sterilization processes.
2. The sterilizer must have a 1.5 minute come-up time to kill the 1491 BI in
3 minutes. If the come-up time is less than 1.5 minutes, extend the cycle
exposure time to 4 minutes to achieve consistent kill.
Temperature Time
270°F (132°C) 3 minutes
270°F (132°C) 10 minutes
275°F (135°C) 3 minutes
275°F (135°C) 10 minutes
3. To reduce the risk associated with incorrect results:
• Do not place tape or labels on 1491 BI prior to sterilization or incubation.
• Do not incubate a 1491 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 BI 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 an
appropriate BI.
Directions for Use
1. 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.
2. Place the 1491 BI in a representative tray configuration as recommended by
professional association guidelines or national standards for hospital practice.
3. 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.
4. Process the load according to recommended practices.
5. After completion of the cycle, take the representative tray out of the sterilizer,
and remove the 1491 BI.
6. Allow the 1491 BI to cool for 10 minutes prior to activation.
7. 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.
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