3M Attest 490H Benutzerhandbuch Seite 8

INSTRUCTIONS FOR USE – READOUT PROCEDURE
Instructions for Biological Indicator (BI) Activation and Incubation
CAUTION: To avoid the possibility of the 3M™ Attest™ Biological Indicator
vial absorbing fluorescent residue from a chemical indicator or tape, place the 3M™
Attest™ 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™ Biological Indicator 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 1295 only in the 3M™
Attest™ Auto‑reader 490H.
Incubate 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V
only in 3M™ Attest™ Auto‑readers 490H having software versions 4.0.0 or greater
and a black incubation well configuration sticker.
CAUTION: Wear safety glasses and gloves when activating the 3M™ Attest™
Rapid Readout Biological Indicator 1295.
CAUTION: Wear safety glasses when activating the 3M™ Attest™ Super Rapid
Readout Biological Indicator.
Follow this procedure for every 3M™ Attest™ Rapid or Super Rapid Readout Biological
Indicator (BI) to be read.
While wearing safety glasses (and gloves for
the 1295 BI), PLACE BI in Attest™ Biological
Indicator Activator.
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.
6
WARNING: Do not remove the 3M™ Attest™ Biological Indicator 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™ 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™ 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™ 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™ Biological Indicator to the reader well within 10 seconds or the
results will be lost
WARNING: Do not remove or change placement of 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.
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™ 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™ 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 1295 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. 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 having the same catalog number reads fluorescent
positive (+).