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9. Discard the challenge pack. Using the challenge pack more than once will invalidate
subsequent test results.
10. To activate the biological indicator, while wearing safety
glasses, place it in an Attest™ Biological Indicator
Activator. Close and squeeze the activator to close the
1492V BI cap and crush the media ampoule. Then remove
the BI and flick it (see pictures at right). Visually verify that
media has flowed into the growth chamber at the bottom
of the vial. If the media hasn't filled the growth chamber,
hold the BI by the cap and flick it until media fills the
growth chamber. Place the activated 1492V BI:
-
in any well of a 490 or 490H Auto-reader having
software version 4.0.0 or greater and a black
incubation well configuration sticker
or
-
in an incubation well of a 490 Auto-reader having
software version less than 4.0.0 which is color-coded
brown (i.e., configured to incubate 1492V BIs)
or
-
in any well of a 490M Auto-reader
and wait for the result. See the Auto-reader Operator's
Manual for further information related to its use.
11. 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 Auto-reader.
12. Incubation and Reading:
Incubate the positive control and steam processed 1492V BIs in a 490 Auto-reader, a 490H
Auto-reader having software version 4.0.0 or greater, or a 490M Auto-reader. See the applicable
Auto-reader Operator's Manual for the proper use of this equipment. The Auto-reader will display
a positive result as soon as it is obtained. The final negative 1492V BI reading is made at:
-
24 minutes in 490 or 490H Auto-readers having software version 4.0.0 or greater and
in 490M Auto-readers
-
1 hour in 490 Auto-readers having software version less than 4.0.0.
After the results are displayed and recorded, the 1492V BIs may be discarded.
Interpretation of Results:
Fluorescent Results
The positive control (unprocessed) 1492V BI must provide a positive fluorescent result (+ on
the Auto-reader display). Processed 1492V BI results are not valid until the positive control
reads fluorescent positive. If the positive control reads negative (- on the display), check the
Auto-reader Operator's Manual Troubleshooting Guide. Retest the Auto-reader with a new
positive control.
With processed 1492V BIs, a positive (+ on the display) result indicates a sterilization process
failure. A final negative (- on the display) result for the processed 1492V BI after the specified
incubation time indicates an acceptable sterilization process.
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