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Optional Visual pH Color Change Result
3M™ Attest™ 1294 Rapid Readout Biological Indicators may be further incubated for
a visual pH color change. Due to the high sensitivity of the fluorescent result, there is no
advantage to incubating the 3M™ Attest™ 1294 Rapid Readout Biological Indicators
beyond 4 hours. This optional further incubation is not intended for routine use but may
be used for special studies. A humidified incubator will be required to avoid media dry out.
In the case of a positive control BI, a yellow color change of the growth media will appear
within 7 days. Any observation of a yellow color within the vial indicates a positive result.
The pH color change result can be recorded and the BI discarded as soon as the yellow
color is observed and the result recorded. In the case of a processed BI, a media color
change from blue-green to yellow indicates a sterilization process failure. A negative pH
color change result, i.e., media remains blue-green, can be assessed at 7 days.
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 390G
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 390G 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 390Gs may be stacked two high.
Information Button
When the Information button is pressed once the 3M™ Attest™ Auto-reader 390G
displays two lines of text in the LCD display.
The top row indicates (left to right):
• 3M™ Attest™ Auto-reader 390G serial number
• 3M™ Attest™ Auto-reader 390G 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 390G 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 390G.
Temperature Monitoring
The 3M™ Attest™ Auto-reader 390G contains an internal temperature self-diagnostic
program. Should the temperature fall outside the specified range (37ºC +/-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 390G may be configured using either the buttons located
on the front of the unit or using the optional 3M™ Attest™ Auto-reader 390G Web App.
Optional 3M™ Attest™ Auto-reader 390G Web App
If desired, the 3M™ Attest™ Auto-reader 390G 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 390G 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 390G 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 390G 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.
CARE AND CLEANING
CAUTION:
Always unplug the 3M™ Attest™ Auto-reader 390G and allow to
cool before cleaning.
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Clean external surfaces using only the instructions provided by the manufacturer.
The instrument must be returned to the manufacturer for repair.
Clean the exterior surface of the 3M™ Attest™ Auto-reader 390G by wiping it with a
damp cloth moistened with a mild detergent. Do not attempt to clean interior components.
If additional cleaning of the wells is required, call for repair or replacement.
Note:
The 3M™ Attest™ Auto-reader 390G does not contain any user serviceable parts
or require any routine maintenance. Any malfunctions will be indicated by an error code.
Refer to the Troubleshooting Guide section for error code explanations.
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 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:
Match the green cap color of the 3M™ Attest™ 1294 Rapid
Readout Biological Indicator with the green color-coded configuration sticker
surrounding the 3M™ Attest™ Auto-reader 390G incubation wells.
CAUTION:
Wear safety glasses when activating 3M™ Attest™ Rapid Readout
Biological Indicators.
Follow this procedure for every 3M™ Attest™ 1294 Rapid Readout Biological Indicator to
be read.
While wearing safety glasses,
CLOSE
the cap of the
cooled 3M™ Attest™ 1294 Rapid Readout Biological
Indicator (BI) by pushing cap down.
CRUSH
the glass media ampoule in the Crusher Well
built into the top of the 390G Auto-reader.
Holding BI by the cap,
TAP
the bottom of the vial on a
tabletop until media wets spore strip at bottom of vial.
Do not tap BI on Auto-reader.
PLACE
the crushed BI in
color-coded
incubation well.
Observe 3M™ Attest™ Auto-reader 390G LCD panel
to confirm correct placement of the BI. If the BI is
correctly seated, the 3M™ Attest™ Auto-reader 390G
LCD panel will display ***, **, * and then 240 remaining
minutes of incubation directly below the incubating BI.
RECORD
BI result.
WARNING:
Do not remove the 3M™ Attest™ 1294 Rapid Readout Biological
Indicator from the incubation well until the (+) or (-) symbol on the LCD panel 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 results are 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.
Note: 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™ 1294 Rapid
Readout Biological Indicator to use as the positive control each day that a processed
3M™ Attest™ 1294 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 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 37ºC +/-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 390G 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 390G 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 four hour 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™
1294 Rapid Readout Biological Indicator after 4 hours of incubation 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™ 1294 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 sterilization process failure.
Act on any positive test results immediately. Determine the cause of the positive
3M™ Attest™ Rapid Readout Biological Indicator and retest the sterilizer following
current facility policies and procedures.
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