3M Attest Auto-reader 490H - Instructions for Use - Readout Procedure; Instructions for Biological Indicator (BI) Activation and Incubation; BI Placement; Instructions for Use - Positive Control

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INSTRUCTIONS FOR USE ‑ READOUTPROCEDURE
Instructions for Biological Indicator (BI) Activation andIncubation
CAUTION: To avoid the possibility of the 3M™ Attest™ Rapid Readout
Biological Indicator 1295vial absorbing fluorescent residue from a chemical indicator
or tape, place the 3M™ Attest™ Rapid Readout Biological Indicator vial so it does not
come in direct contact with chemical indicators or tape.
WARNING: To reduce the risk associated with incorrect results
Do not incubate a 3M™ Attest™ Rapid Readout Biological Indicator 1295if, after
processing and before BI activation, it is observed to have a broken media ampoule.
Retest the sterilizer with a new biological indicator.
Activate and incubate 3M™ Attest™ Rapid Readout Biological Indicators 1295within
1hour of the completion of the sterilization cycle.
Incubate the 3M™ Attest™ Rapid Readout Biological Indicator only in the
3M™ Attest™ Auto‑reader 490H i.e., match the pink cap color of the 1295BI with
the pink color‑coded configuration sticker surrounding the 3M™ Attest™ Auto‑reader
490H incubation wells.
CAUTION: Wear safety glasses and gloves when activating the 3M™ Attest™
Rapid Readout Biological Indicator 1295.
Follow this procedure for every 3M™ Attest™ Rapid Readout Biological Indicator (BI) to
beread.
or
While wearing safety glasses and gloves,
PLACE BI in color‑coded 3M™ Attest™
Auto‑reader490H well. Note that BI
vial is keyed for specific orientation
in well (flat back of BI faces back of
3M™ Attest™ Auto‑reader490H).
While wearing safety glasses and gloves,
PLACE BI in Attest™ Biological Indicator
Activator.
or
CLOSE BI cap and CRUSH media
ampoule by firmly pushing vial straight
down in incubationwell.
CLOSE and SQUEEZE Attest™ Biological
Indicator Activator to close BI cap and crush
media ampoule.
Immediately remove BI, visually VERIFY the glass ampoule
(containing growth media) has been crushed, and FLICK BI to
ensure purple growth media flows to the growth chamber at the
bottom of thevial.
PLACE the activated BI into a 3M™ Attest™ Auto-reader 490H
well and observe 3M™ Attest™ Auto-reader 490H LCD display
to confirm correct placement of the BI. If the BI is correctly
seated, the 3M™ Attest™ Auto-reader 490H LCD display will
show ***, **, * and then remaining minutes of incubation directly
below the incubating BI.
RECORD BIresult.
WARNING: Do not remove the 3M™ Attest™ Rapid Readout Biological
Indicator 1295from the incubation well until the (+) or (‑) symbol on the LCD display
indicates the testis complete.
INSTRUCTIONS FOR USE – ADDITIONALINFORMATION
BIPlacement
Remaining incubation time, in minutes, will be displayed on the LCD display to indicate
the 3M™ Attest™ Rapid Readout Biological Indicator is incubating in the reader well and
should not be touched. The time remaining display indicates the result is not available and
incubation is inprogress.
Do not remove 3M™ Attest™ Rapid Readout Biological Indicator 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™ Rapid Readout Biological
Indicator is inadvertently removed before the incubation period is complete, an alarm will
sound and a C2Caution code will be displayed on the LCD panel under that well. You
must return the 3M™ Attest™ Rapid Readout 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™ Rapid
Readout Biological Indicator once it is placed into a well. Doing so may result in loss of
results and the 3M™ Attest™ Rapid Readout Biological Indicator test may be invalid.
INSTRUCTIONS FOR USE – POSITIVECONTROL
PositiveControl
Activate and incubate at least one non‑processed 3M™ Attest™ Rapid Readout Biological
Indicator 1295to use as the positive control each day that a processed 3M™ Attest™
Rapid Readout Biological Indicator 1295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. The positive control should be the same part number and have the same lot number
as the processed 3M™ Attest™ Rapid Readout Biological Indicator in theunit.
The positive control biological indicator helpsconfirm:
• correct incubation temperatures are met (heater block reading of 60°C+/‑2°C);
• 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 490Hcomponents.
INSTRUCTIONS FOR USE – INTERPRETATION OFRESULTS
FluorescentResults
After placing a 3M™ Attest™ Rapid Readout Biological Indicator into an incubation
well, the 3M™ Attest™ Auto‑reader 490H LCD display will show ***, **, * and then
the remaining minutes of incubation directly below the incubating BI to indicate that
incubation/reading is inprogress. The 3M™ Attest™ Rapid Readout 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™ Rapid Readout Biological
Indicator result isdetected.
At the end of the specified incubation time, if a negative 3M™ Attest™ Rapid Readout
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™
Rapid Readout Biological Indicator 1295indicates an acceptable sterilizationprocess.
After either the (+) or (–) symbol is displayed, and the result is recorded, the
3M™ Attest™ Rapid Readout Biological Indicator can be removed from the well. Do not
re-incubate BIs as the result will not be valid.
The positive (unprocessed) control 3M™ Attest™ Rapid Readout Biological Indicator
1295must provide a positive fluorescent result (+). Processed 3M™ Attest™ Rapid
Readout Biological Indicator results are not valid until the positive control reads fluorescent
positive(+).