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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
or in a 490M Auto-reader 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 a 490, 490H, or 490M 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 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 Readout Steam Challenge Pack 1496V in conjunction
with the 3M™ Attest™ Auto-reader 490, the Attest™ Auto-reader 490H having software
version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M 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 Readout Steam Challenge Pack 1496V 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 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 or death 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 BI by the cap when crushing and flicking.
•
Do not use your fingers to crush the glass ampoule.
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