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 Part number, and have the same lot number as the processed 3M™ Attest™ Super Rapid Readout Biological Indicator in the unit.
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‑reader 490 components.
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‑reader 490 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™ Super Rapid Readout Biological Indicator result is detected.
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 incubation time.
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 process failure.
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 are negative.
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 30 minutes and 1 hour, 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 1491 BIs and at 48 hours for 1492V BIs.
INSTRUCTIONS FOR USE – Disposal
Instrument contains a lithium battery. Dispose of instrument in accordance with federal, state, and local requirements.
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‑reader 490 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 10 seconds.
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 configuration section.
Stackable
To save counter space, 3M™ Attest™ Auto‑reader 490s may be stacked two high.
Information Button
When the Information button is pressed once the 3M™ Attest™ Auto‑reader 490 displays two lines of text in the LCD display.
The top row indicates (left to right):
•3M™ Attest™ Auto‑reader 490 serial number
•3M™ Attest™ Auto‑reader 490 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 490 LCD panel will display:
•Top row: Dynamic IP address (if unit is connected to an Ethernet jack)
•Bottom row: Date (YYYY‑MM‑DD) and time that power was supplied to the 3M™ Attest™ Auto‑reader 490.
Temperature Monitoring
The 3M™ Attest™ Auto‑reader 490 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 Button once.
Easy Configuration
The 3M™ Attest™ Auto‑reader 490 may be configured using either the buttons located on the front of the unit or using the optional 3M™ Attest™ Auto‑reader 490 Web App.
Optional 3M™ Attest™ Auto‑reader 490 Web App
If desired, the 3M™ Attest™ Auto‑reader 490 may be connected to a PC via an Ethernet connection for additional capabilities:
•Remotely view current status of BIs in the 3M™ Attest™ Auto‑reader 490 via PC or mobile hand held devices. For full functionality, the use of an HTML5 compliant browser with JavaScript enabled is recommended.
•Remotely view and configure 3M™ Attest™ Auto‑reader 490 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‑reader 490 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 and procedure.
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