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CI to assure the ink of the CI is not smeared or
runny. If the BI media ampoule is intact and the
ink of the CI (if included) appears typical remove
the BI from the sterilization pouch and proceed to
Step 6. If the media ampoule is broken or if the ink
of the CI appears smeared or runny, leave them
in the sterilization pouch and follow the disposal
instructions. Retest the sterilizer using a new 1295 BI
and CI (if included).
6. Check the process indicator on the top of the cap
of the 1295 BI. A color change of the stripes from
blue towards pink confirms that the 1295 BI has
been exposed to the vaporized hydrogen peroxide
sterilization process. This color change does not
indicate that the process was sufficient to achieve
sterility. If the process indicator is unchanged, check
the sterilizer physical monitors.
7. Identify the 1295 BI by writing the load number,
sterilizer, and processing date on the indicator label.
8. Activate the 1295 BI.
While wearing safety glasses
and gloves, place the 1295 BI
in an Attest™ Biological
Indicator Activator. Close and
squeeze the activator to close
the 1295 BI cap and crush the
media ampoule (see pictures
at right). Immediately remove
the BI and flick it (see
pictures). 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
1295 BI in a 490H Auto-reader
or 490 Auto-reader having
software version 4.0.0 or
greater or 490M Auto-reader
and wait for the result. See the
applicable Auto-reader
Operator's Manual for further
information related to its use.
NOTE: Activate and incubate the 1295 BI within
1 hour of the completion of the sterilization cycle.
9. Each day that a processed 1295 BI is incubated,
activate and incubate at least one non-processed
1295 BI to use as a positive control. Follow the
activation instructions provided in Step 8 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.
10. Incubation and Reading:
Incubate the positive control and processed 1295
BIs at 60 ± 2°C in a 490H Auto-reader or 490
Auto-reader having software version 4.0.0 or greater
or 490M Auto-reader. See the applicable Auto-
reader Operator's Manual for the proper use of this
equipment. The Auto-reader will indicate a positive
result as soon as it is obtained. The final negative
1295 BI reading is made at:
-
24 minutes in 490H or 490 Auto-readers having
software version 4.0.0 or greater
-
4 hours in 490H Auto-readers having a software
version less than 4.0.0.
-
24 minutes in a 490M Auto-reader
After the results are displayed and recorded, the
1295 BIs may be discarded.
Fluorescent Result
The positive control (unprocessed) 1295 BI must
provide a positive fluorescent result (+ symbol on
the 490H Auto-reader or 490 Auto-reader having
software version 4.0.0 or greater or 490M Auto-reader
display). Processed 1295 BI results are not valid until
the positive control reads fluorescent positive. If the
positive control reads negative (- symbol on the display),
check the applicable Auto-reader Operator's Manual
Troubleshooting Guide. Retest the 490H Auto-reader
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