Features Of The 3M™ Attest™ Mini Auto-Reader 490M - 3M Attest 490M Manual Del Usuario

INSTRUCTIONS FOR USE – Additional
Information
BI Placement
All incubation wells in the 3M™ Attest™ Mini Auto-reader 490M are programmed
to provide a final fluorescent result within 24 minutes of incubation and may be used
to incubate 3M™ Attest™ Super Rapid Biological Indicators 1491 and 1492V and the
3M™ Attest™ Rapid Readout Biological Indicator 1295�
Remaining incubation time, in minutes, will be displayed on the front of the unit to
indicate the 3M™ Attest™ Biological Indicator is incubating in the reader well and
should not be touched� The time remaining display indicates the results are not
available and incubation is in progress� Do not remove 3M™ Attest™ Biological
Indicators until the (+) or (‑) symbol on the display indicates the test is complete.
Note: If a 3M™ Attest™ Biological Indicator is inadvertently removed before the
incubation period is complete, an alarm will sound, and a C2 caution code will be
displayed under that well� You must return the 3M™ Attest™ Biological Indicator to
the incubation 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
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�
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 3M™ Attest™ Mini Auto-reader 490M components�
INSTRUCTIONS FOR USE –
Interpretation of Results
Fluorescent Results
As soon as a positive 3M™ Attest™ Biological Indicator result is detected, a flashing
(+) symbol will be displayed directly under the incubating BI and an alarm will
sound (if the sound feature is enabled)� Tap the touch button to acknowledge the
result, stop the flashing display, and silence the alarm (if enabled)� At the end of the
24-minute incubation time, if a negative 3M™ Attest™ Biological Indicator result is
detected, a (-) symbol will be displayed 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�
FEATURES OF THE 3M™ ATTEST™ MINI AUTO‑READER 490M
Audible Alarm
An audible alarm will sound and a flashing (+) symbol will be displayed directly under
the incubating BI when a positive result is detected� An alarm will also sound if an
incubating BI is removed from the 3M™ Attest™ Mini Auto-reader 490M incubation
well before a result has been determined� Data will be lost if the BI is not replaced in
the incubation well within 10 seconds�
The audible alarm for positive results can be silenced for a particular 3M™ Attest™
Biological Indicator� This is accomplished by pressing the touch button after
the alarm has sounded� This will turn off the alarm for that BI only� Any positive
3M™ Attest™ Biological Indicator results subsequently detected in other incubation
wells will result in the alarm sounding� Removing the BI reactivates the alarm for that
well� Pressing the touch button to silence the alarm for a positive BI does not disable
the alarm for error or caution code alarm warnings� The default factory setting is
audible alarm enabled� The alarm can be disabled in the 3M™ Attest™ Connect
Settings page�
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 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 unprocessed control BI must provide a positive fluorescent result (+)� Processed
BI results are not valid until the daily positive control BI 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 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 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�
If a visual pH color change result is desired for processed 3M™ Attest™
Rapid Readout Biological Indicators 1295, the use of a humidified incubator
is recommended to avoid media dry-out� Transfer the processed 1295 BI to a
humidified incubator operating at 60ºC after the fluorescent result has been
determined by the 3M™ Attest™ Mini Auto-reader 490M� 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�
Serial Number, Firmware Version, and
Temperature Status
To check the serial number, firmware version, or heater block temperature, press
and hold the touch button� The unit's serial number, firmware version, and incubator
block temperature will sequentially appear on the Display� The 3M™ Attest™ Mini
Auto-reader 490M contains an internal temperature self-diagnostic program�
Should the temperature fall outside the specification (60�0ºC +/- 2�0ºC), an error
code will be displayed�
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