Features - 3M Attest Auto-reader 390 Benutzerhandbuch

INSTRUCTIONS FOR USE – Positive Control
Positive Control
Activate and incubate at least one non-processed 3M™ Attest™ Rapid Readout Biological
Indicator to use as the positive control each day that a processed 3M™ Attest™ Rapid
Readout 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 appropriately
configured (i.e., blue or brown) incubator 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 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 390 components.
INSTRUCTIONS FOR USE – Interpretation of Results
Fluorescent Results
After placing a 3M™ Attest™ Rapid Readout Biological Indicator into a corresponding
color-coded well, the 3M™ Attest™ Auto-reader 390 LCD panel will display ***, **, * and
then the remaining minutes of incubation directly below the incubating BI to indicate that
incubation/reading is in progress.
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 after 1 hour or 3 hours of incubation, for 1291 and
1292 BIs, respectively, indicates an acceptable sterilization process. The positive control
should read positive (+).
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. The 3M™ Attest™
Rapid Readout Biological Indicator should not be removed or touched when the display
indicates remaining incubation time.
The positive (unprocessed) control 3M™ Attest™ Rapid Readout Biological Indicator
must provide a positive fluorescent result (+). Processed 3M™ Attest™ Rapid Readout
Biological Indicator results are not valid until the positive control reads fluorescent
positive (+). With a processed 3M™ Attest™ Rapid Readout Biological Indicator, a
positive (+) result indicates a steam sterilization process failure.
Act on any positive test results immediately. Determine the cause of the positive
3M™ Attest™ Rapid Readout Biological Indicator following current facility policies and
procedures. Always retest the sterilizer and do not use the sterilizer for processing loads
until 3 consecutive 3M™ Attest™ Rapid Readout Biological Indicator results are negative.
Optional Visual pH Color Change Result
3M™ Attest™ 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™ Rapid Readout Biological Indicators 1291 and
1292 beyond 1 and 3 hours, respectively. In the case of a positive control BI, a yellow color
change of the growth media will appear within 24 hours for 1291 BIs and within 48 hours
for 1292 BIs. Any observation of a yellow color within the vial indicates a positive result. In
the case of a processed BI, a media color change from purple to yellow indicates a steam
sterilization process failure. A negative pH color change result, i.e., media remains purple,
can be assessed at 24 hours for 1291 BIs and at 48 hours for 1292 BIs.
INSTRUCTIONS FOR USE – Disposal
Instrument contains a lithium battery. Dispose of instrument in accordance with federal,
state, and local requirements.
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FEATURES OF THE 3M™ ATTEST™ AUTO-READER 390
Audible Alarm
An audible alarm will sound, the LCD display backlight will flash, and a (+) symbol will
be displayed on the LCD panel directly under the incubating BI when a positive result is
detected. An alarm will also sound if a 3M™ Attest™ Rapid Readout Biological Indicator
is removed from the 3M™ Attest™ Auto-reader 390 well before a final result has been
detected. Data will be lost if the 3M™ Attest™ Rapid Readout Biological Indicator is not
replaced in the incubation well within 10 seconds.
Alarm On/Off
The audible alarm for positive results can be turned off for a particular 3M™ Attest™
Rapid Readout Biological Indicator. This is accomplished by pressing the "Buzzer Alarm
OFF" button after the alarm has sounded. This will turn off the alarm for that BI only. Any
positive 3M™ Attest™ Rapid Readout Biological Indicator results subsequently detected
in other wells will result in the alarm sounding. Removing the 3M™ Attest™ Rapid
Readout Biological Indicator will reactivate the alarm for that well. Pressing the "Buzzer
Alarm OFF" button will not silence the alarm for error or caution code alarm warnings. To
disable the alarm, see configuration section.
Stackable
To save counter space, 3M™ Attest™ Auto-reader 390s may be stacked two high.
Information Button
When the Information button is pressed once the 3M™ Attest™ Auto-reader 390 displays
two lines of text in the LCD display.
The top row indicates (left to right):
• 3M™ Attest™ Auto-reader 390 serial number
• 3M™ Attest™ Auto-reader 390 embedded software version (V X.Y.Z)
• Current date and time.
The bottom row indicates (left to right):
• The BI type configuration for wells 1-5.
• The BI type configuration for wells 6-10.
Press the information button twice and the 3M™ Attest™ Auto-reader 390 LCD panel will
display two additional lines of text.
The top row indicates:
• Dynamic IP address (if unit is connected to an Ethernet jack).
The bottom row indicates (left to right):
• Date (YYYY-MM-DD) and time that power was supplied to the 3M™ Attest™
Auto-reader 390.
Temperature Monitoring
The 3M™ Attest™ Auto-reader 390 contains an internal temperature self-diagnostic
program. Should the temperature fall outside the specified range (60 ºC +/-2ºC) an error
code will be displayed. The heater block temperature may be checked by depressing the
Temperature button once.
Easy Configuration
The 3M™ Attest™ Auto-reader 390 may be configured using either the buttons located
on the front of the unit or using the optional 3M™ Attest™ Auto-reader 390 Web App.
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