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Readout Times
The super rapid readout and the optional 48-hour visual pH color change incubation times have been
correlated with a 7-day incubation period following the FDA's Reduced Incubation Time protocol.
Processed indicators were examined at 48 hours and 7 days for detection of a visual pH color change. The
fluorescent result and the 48-hour visual pH color change readings were compared to the 7-day visual pH
color change readings to determine the readout time of the indicator. The time to a fluorescent result is
determined by the software version programmed on the Auto-reader.
24-minute Fluorescent Result
1492V BIs incubated in a 490 or 490H Auto-reader having software version 4.0.0 or greater have
a 24-minute reduced incubation time result that correlates to the 7-day (168 hours) visual readout
result ≥ 97% of the time.
1-hour Fluorescent Result
1492V BIs incubated in a 490 Auto-reader having a software version less than 4.0.0 have a 1- hour
reduced incubation time result that correlates to the 7-day (168 hours) visual readout result ≥ 97%
of the time.
48-hour Visual pH Color Change Result
1492V BIs incubated in either a 490 or 490H Auto-reader have 48 hour reduced incubation time
results that correlate to the 7-day (168 hours) visual readout result ≥ 97% of the time.
Due to the high reliability of the fluorescent result there is no advantage to incubating 1492V BIs
after the fluorescent result has been determined by the 490 or 490H Auto-reader and recorded.
Note: To determine the software version on a 490 or 490H Auto-reader, depress the Information
Button once. The Auto-reader will display two lines of text on the LCD display. The top row indicates
(left to right):
•
Serial number
•
Software version (V X.Y.Z)
•
Current date and time.
Indications for Use
United States
Use the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the
3M™ Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or
greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C)
and 3 minutes at 275°F (135°C).
Outside the United States
Use the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with
the 3M™ Attest™ Auto-reader 490 or 3M™ 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. To avoid the risk of serious injury
from flying debris due to a ruptured ampoule:
•
Allow the biological indicator 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 when activating the biological indicator.
•
Handle the biological indicator by the cap when crushing and flicking.
•
Do not use your fingers to crush the glass ampoule.
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