3M VH202 Manuel De L'utilisateur page 8

Do not remove 3M™ Attest™ Biological Indicators until the (+) or (-) symbol on
the LCD panel indicates the test is complete. Once the result is determined, it is
continuously displayed on the LCD panel until 10 seconds after the BI has been removed
from the incubation well.
Note: After the first minute of incubation, if 3M™ Attest™ Biological Indicators are
inadvertently removed before the incubation period is complete, an alarm will sound
and a C2 Caution code will also be displayed on the LCD panel under that well. You must
return the 3M™ Attest™ Biological Indicator to the reader well within 10 seconds
or the results will be lost.
WARNING: Do not remove or change placement of 3M™ Attest™ Biological
Indicator once it is placed into a well. Doing so may result in loss of results and the
biological indicator test may be invalid.
INSTRUCTIONS FOR USE – Positive Control
Positive Control
Activate and incubate at least one non-processed 3M™ Attest™ Biological Indicator
to use as the positive control each day that a processed 3M™ Attest™ Biological
Indicator is incubated and read by the unit. Write a "C" (for "control") and the date on
the label. The positive control can be placed in any incubation well. A positive control
should be run for each catalog number, and have the same lot number as the processed
3M™ Attest™ Biological Indicator.
It is good practice to use a positive control each day a processed 3M™ Attest™
Biological Indicator is incubated. This helps confirm:
• correct incubation temperatures are met (heater block reading of 60ºC +/-2ºC).
• 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 3M™ Attest™ Auto-reader 490 components.
INSTRUCTIONS FOR USE – Interpretation of Results
Fluorescent Results
After placing a 3M™ Attest™ Biological Indicator into an incubation well, the 3M™
Attest™ Auto-reader 490 LCD panel will display ***, **, * and then the remaining minutes
of incubation directly below the incubating BI to indicate that incubation/reading is in
progress. The 3M™ Attest™ Biological Indicator should not be removed or touched when
the display indicates remaining incubation time.
A (+) will display on the LCD panel directly under the BI and an alarm will sound (if the
sound feature is enabled), as soon as a positive 3M™ Attest™ Biological Indicator result
is detected.
At the end of the specified incubation time, if a negative 3M™ Attest™ Biological
Indicator result is detected, a (-) will display on the LCD panel directly under the incubating
BI. The final negative fluorescent result (-) for a processed 3M™ Attest™ Biological
Indicator after 24 minutes of incubation indicates an acceptable sterilization process.
After either the + or – symbol is displayed, and the result is recorded, the 3M™ Attest™
Biological Indicator can be removed from the well. The result (+ or -) is displayed on the
LCD panel until the BI is removed from the incubation well. The result clears ten seconds
after the BI has been removed. Do not re-incubate BIs as the result will not be valid.
The positive (unprocessed) control 3M™ Attest™ Biological Indicator must provide a
positive fluorescent result (+). Processed 3M™ Attest™ Biological Indicator results
are not valid until the positive control reads fluorescent positive (+). With a processed
3M™ Attest™ Biological Indicator, a positive (+) result indicates a sterilization
process failure.
Act on any positive test results immediately. Determine the cause of the positive
3M™ Attest™ Biological Indicator and retest the sterilizer following current facility
policies and procedures.
Optional Visual pH Color Change Result - 3M™ Attest™ Super Rapid
Readout Biological Indicators 1491 and 1492V
3M™ Attest™ Super Rapid Readout Biological Indicators may be further incubated for
a visual pH color change. This optional further incubation is not intended for routine use
and may be used for special studies. Due to the high sensitivity of the fluorescent result,
there is no advantage to incubating the 3M™ Attest™ Super Rapid Readout Biological
Indicators 1491 and 1492V beyond 24 minutes. After activation and during incubation,
the white Nonwoven Material in the biological indicator will absorb bromocresol purple
indicator, the pH-sensitive indicator dye in the growth media, and appear blue. In the
case of a positive control BI, a yellow color change of the growth media and/or Nonwoven
Material will appear within 24 hours for 1491 BIs and within 48 hours for 1492V BIs.
Any observation of a yellow color within the vial indicates a positive result. In the case of
a processed BI, a media and/or Nonwoven material color change from purple to yellow
indicates a steam sterilization process failure. A negative pH color change result, i.e.
media and Nonwoven Material remain purple/blue, can be assessed at 24 hours for
1491 BIs and at 48 hours for 1492V BIs.
Optional Visual pH Color Change Result - 3M™ Attest™ Rapid
Readout Biological Indicator 1295
3M™ Attest™ Rapid Readout Biological Indicators 1295 for Vaporized Hydrogen Peroxide
Sterilization may be further incubated for a visual pH color change. Due to the high
sensitivity of the fluorescent result, there is no advantage to continuing to incubate 3M™
Attest™ Rapid Readout Biological Indicators 1295 after the fluorescent result has been
determined and documented. This optional further incubation is not intended for routine
use but may be used for special studies.
In the case of a 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. The pH color change result can be recorded and the BI discarded as soon as the
yellow color is observed.
For processed 3M™ Attest™ Rapid Readout Biological Indicators 1295, the use of a
humidified incubator is recommended to avoid media dry out. If a visual pH color change
result is desired, transfer the processed 1295 BI to a humidified incubator after the
fluorescent result has been determined in the 3M™ Attest™ Auto-reader 490. 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.
INSTRUCTIONS FOR USE – Disposal
Instrument contains a lithium battery. Dispose of instrument in accordance with federal,
state, and local requirements.
7