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INSTRUCTIONS FOR USE – Positive Control
Positive Control
Activate and incubate at least one non‑processed 3M™Attest™ Super Rapid
Readout Biological Indicator to use as the positive control each day that a processed
3M™Attest™ Super 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 Partnumber, and have the same lot number as the processed
3M™Attest™ Super Rapid Readout Biological Indicator in theunit.
It is good practice to use a positive control each day a processed 3M™Attest™ Super
Rapid Readout Biological Indicator is incubated. This helps confirm:
•
correct incubation temperatures are met (heater block reading of 56.5 ºC +/‑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‑reader490components.
INSTRUCTIONS FOR USE – Interpretation of Results
Fluorescent Results
After placing a 3M™Attest™ Super Rapid Readout Biological Indicator into a
corresponding color‑coded well, the 3M™Attest™ Auto‑reader490 LCD panel will
display ***, **, * and then the remaining minutes of incubation directly below the
incubating BI to indicate that incubation/reading is inprogress.
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™ Super Rapid Readout
Biological Indicator result isdetected.
At the end of the specified incubation time, if a negative 3M™Attest™ Super 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™ Super Rapid Readout Biological Indicator after 30 minutes or 1 hour of
incubation, for 1491 and 1492V 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™
Super Rapid Readout Biological Indicator can be removed from the well. The
3M™Attest™ Super Rapid Readout Biological Indicator should not be removed or
touched when the display indicates remaining incubationtime.
The positive (unprocessed) control 3M™Attest™ Super Rapid Readout Biological
Indicator must provide a positive fluorescent result (+). Processed 3M™Attest™ Super
Rapid Readout Biological Indicator results are not valid until the positive control reads
fluorescent positive (+). With a processed 3M™Attest™ Super Rapid Readout Biological
Indicator, a positive (+) result indicates a steam sterilization processfailure.
Act on any positive test results immediately. Determine the cause of the positive
3M™Attest™ Super 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™ Super Rapid Readout Biological Indicator results
arenegative.
Optional Visual pH Color Change Result
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 30minutes and 1hour, respectively. 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 1491BIs 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
1491BIs and at 48 hours for 1492VBIs.
INSTRUCTIONS FOR USE – Disposal
Instrument contains a lithium battery. Dispose of instrument in accordance with federal,
state, and localrequirements.
FEATURES OF THE 3M™ ATTEST™ AUTO‑READER 490
Audible Alarm
An audible alarm will sound, the LCD Display backlight will flash, and a (+) symbol 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™ Super Rapid Readout Biological
Indicator is removed from the 3M™Attest™ Auto‑reader490 well before a final result
has been detected. Data will be lost if the 3M™Attest™ Super Rapid Readout Biological
Indicator is not replaced in the incubation well within 10seconds.
Alarm On/Off
The audible alarm for positive results can be turned off for a particular 3M™Attest™
Super 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
Super Rapid Readout Biological Indicator only. Any positive 3M™Attest™ Super Rapid
Readout Biological Indicator results subsequently detected in other wells will result in the
alarm sounding. Removing the 3M™Attest™ Super 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
configurationsection.
Stackable
To save counter space, 3M™Attest™ Auto‑reader490s may be stacked twohigh.
Information Button
When the Information button is pressed once the 3M™Attest™ Auto‑reader490 displays
two lines of text in the LCDdisplay.
The top row indicates (left to right):
•
3M™Attest™ Auto‑reader490 serial number
•
3M™Attest™ Auto‑reader490 embedded software version (VX.Y.Z)
•
Current date andtime.
The bottom row indicates (left to right):
•
The BI type configuration for wells 1‑5.
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The BI type configuration for wells 6‑10.
Press the information button twice and the 3M™Attest™ Auto‑reader490 LCD panel will
display:
•
Top row: Dynamic IP address (if unit is connected to an Ethernetjack)
•
Bottom row: Date (YYYY‑MM‑DD) and time that power was supplied to the
3M™Attest™ Auto‑reader490.
Temperature Monitoring
The 3M™Attest™ Auto‑reader490 contains an internal temperature self‑diagnostic
program. Should the temperature fall outside the specified range (56.5ºC +/‑2ºC) an error
code will be displayed. The heater block temperature may be checked by depressing the
Temperature Buttononce.
Easy Configuration
The 3M™Attest™ Auto‑reader490 may be configured using either the buttons located
on the front of the unit or using the optional 3M™Attest™ Auto‑reader490 WebApp.
Optional 3M™Attest™ Auto‑reader490 Web App
If desired, the 3M™Attest™ Auto‑reader490 may be connected to a PC via an Ethernet
connection for additional capabilities:
•
Remotely view current status of BIs in the 3M™Attest™ Auto‑reader490 via PC
or mobile hand held devices. For full functionality, the use of an HTML5 compliant
browser with JavaScript enabled isrecommended.
•
Remotely view and configure 3M™Attest™ Auto‑reader490 settings
•
View the last 100 BI records
•
Print out documentation using a local or networked printer and/or save documentation
as an electronic file.*
Note: To access the 3M™Attest™ Auto‑reader490 Web App within a secure network,
the PC or mobile device must have access to the secure network; options include
connecting via a network Ethernet cable, signing in to the facility’s wireless network, or
connecting via a virtual private network (VPN).
* Refer to your facility’s record keeping policy andprocedure.