3M Attest 1295 - Page 6

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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. See the 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.
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 LCD display).
Processed 1295BI results are not valid until the
positive control reads fluorescent positive. If the
positive control reads negative (‑ symbol on the LCD
display), check the Auto‑reader Operator’s Manual
Troubleshooting Guide. Retest the 490H Auto‑reader
or 490Auto‑reader having software version 4.0.0or
greater with a new positivecontrol.
With processed 1295BIs, a final negative reading
(‑ symbol on the LCD display) indicates an acceptable
sterilization process. A positive (+ symbol on the LCD
display) result for a processed 1295BI indicates a
sterilization process failure. Act immediately on any
positive results for processed BIs. Determine the
cause of the positive BI following facility policies and
procedures. 3M recommends retesting the sterilizer
according to your facility policy before processing
additionalloads.
Optional Visual pH Color ChangeResult
The 1295BI is normally discarded after the fluorescent
result has been recorded. If, however, special studies
are desired, 1295BIs may be further incubated for
a visual pH color change result. In the case of the
positive control BI, a yellow color change of the growth
media will appear within 24hours. Any observation of
a yellow color within the vial indicates a positiveresult.
In the case of a processed 1295BI, a media color
change from purple to yellow indicates a sterilization
process failure. A negative pH color change result,
i.e., media remains purple, can be assessed at 7days.
To avoid media dry‑out, it is recommended that the
1295BI be transferred to a humidified incubator
operating at 60ºC after the fluorescent result has
beenrecorded.