3M 1492V User manual

Attest™
1Super Rapid Readout B iological Indicator
2Indicateur biologique à lecture super rapide
3Bioindikator zur
U ltraschnellauslesung
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I ndicatore biologico a lettura s uper rapida
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I ndicador biológico de lectura s uperrápida
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7Super Rapid Readout
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8Biologisk indikator
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9Superhurtig avlesning
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0Super Rapid Readout
b iologinen pikaindikaattori
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I ndicador Biológico de Leitura Super‑rápida
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W skaźnik biologiczny o bardzo szybkim o dczycie
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B iologický indikátor s rychlým odečtem
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TSuper Rapid Readout Biological Indicator
1 492V

1
3M™Attest™Super Rapid Readout 1
Biological Indicator 1492V
ProductDescription
The 3M™Attest™ Super Rapid
Readout Biological Indicator
1492V (brown cap, referred to
hereinafter as the 1492VBI)
is a self-contained biological
indicator specifically designed for
rapid and reliable qualification
testing and routine monitoring
of 270°F (132°C) and 275°F
(135°C) dynamic-air-removal
(pre-vacuum and steam-flush
pressure-pulse (SFPP)) steam
sterilization processes when
used in conjunction with a
3M™Attest™ Auto-reader
490(hereinafter referred to
as the 490Auto-reader) or a
3M™Attest™ Auto-reader 490H
having software version 4.0.0or
greater (hereinafter referred to
as the 490H Auto-reader). The
1492VBI is a single-use device.
A schematic illustrating the design of the 1492VBI is provided in
Figure 1. The self-contained design includes a carrier with spores of
Geobacillusstearothermophilus and a media ampoule containing bacteriological
growth medium which meets the requirements for growth promoting ability specified
in ISO 11138-1:2017. The spore carrier and media ampoule are contained in a
plastic vial topped with a brown cap. A chemical process indicator which changes
from pink to light brown or darker upon exposure to steam is located on the top
of the cap.
The 1492VBI utilizes the α-glucosidase enzyme system, which is generated
naturally within growing cells of Geobacillusstearothermophilus. The α-glucosidase
in its active state is detected by measuring the fluorescence produced by the
enzymatic hydrolysis of a non-fluorescent substrate, 4-methylumbelliferyl-α-D-gl
ucoside (MUG). The resultant fluorescent by-product, 4-methylumbelliferone (MU),
is detected in the Auto-reader. The presence of fluorescence within the specified
incubation time of the 1492VBI in the 490or 490H Auto-reader indicates a steam
sterilization process failure.
The 1492VBI can also indicate the presence of G.stearothermophilus organisms by
a visual pH color change reaction. Biochemical activity of the G.stearothermophilus
organism produces metabolic by-products that cause the media to change color
from purple to yellow which also indicates a steam sterilization process failure. Use
of this indication method is optional and is typically restricted to special studies.
1492VBIs meet ISO 11138-1:2017and ISO 11138-3:2017.
ReadoutTimes
The super rapid readout and the optional 48-hour visual pH color change incubation
times have been correlated with a 7-day incubation period following the FDA’s
Reduced Incubation Time protocol. Processed indicators were examined at 48hours
and 7days for detection of a visual pH color change. The fluorescent result and
the 48-hour visual pH color change readings were compared to the 7-day visual
pH color change readings to determine the readout time of the indicator. The time
to a fluorescent result is determined by the software version programmed on the
Auto-reader.
24-minute Fluorescent Result
1492VBIs incubated in a 490or 490H Auto-reader having software version
4.0.0or greater have a 24minute reduced incubation time result that correlates
to the 7day (168hours) visual readout result ≥ 97% of the time.
1-hour Fluorescent Result
1492VBIs incubated in a 490Auto-reader having a software version less than
4.0.0have a 1hour reduced incubation time result that correlates to the 7day
(168hours) visual readout result ≥97% of the time.
48-hour Visual pH Color Change Result
1492VBIs incubated in either a 490or 490H Auto-reader have 48hour reduced
incubation time results that correlate to the 7day (168hours) visual readout
result ≥97% of the time.
Due to the high reliability of the fluorescent result there is no advantage to
incubating 1492VBIs after the fluorescent result has been determined by the 490or
490H Auto-reader and recorded.
Note: To determine the software version on a 490or 490H Auto-reader, depress the
Information Button once. The Auto-reader will display two lines of text on the LCD
display. The top row indicates (left to right):
• Serial number
• Software version (V X.Y.Z)
• Current date and time.
PROCESS INDICATOR
BI CAP WITH LABEL
VIAL
MEDIA AMPOULE
AMPOULE CRUSHER
NONWOVEN MATERIAL
GROWTH CHAMBER
SPORE CARRIER
Figure 1: 3M™Attest™ Super Rapid Readout
Biological Indicator 1492V Design
5324306 5
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05.17.18 Final release. TN

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Indications forUse
UnitedStates
Use the 3M™Attest™ Super Rapid Readout Biological Indicator 1492V in
conjunction with both the 3M™Attest™ Auto-reader 490or the Attest™
Auto-reader 490H having software version 4.0.0or greater to qualify or monitor
dynamic-air-removal steam sterilization cycles of:
• 3minutes at 270°F (132°C)
• 4minutes at 270°F (132°C)
• 3minutes at 275°F (135°C).
Outside the UnitedStates
Use the 3M™Attest™ Super Rapid Readout Biological Indicator 1492V in
conjunction with the 3M™Attest™ Auto-reader 490or Attest™ Auto-reader 490H
having software version 4.0.0or greater to qualify or monitor 270°F (132°C) to
275°F (135°C) dynamic-air-removal steam sterilization cycles.
Contraindications
None.
Warnings
There is a glass ampoule inside the plastic vial of the biological indicator (BI). To
avoid the risk of serious injury from flying debris due to a ruptured BI:
• Allow the BI to cool for the recommended time period before activating.
Activating or excessive handling of the BI before cooling may cause the glass
ampoule to burst.
• Wear safety glasses and gloves when removing the BI from the sterilizer.
• Wear safety glasses when activating the BI.
• Handle the BI by the cap when crushing or flicking.
• Do not use your fingers to crush the glass ampoule.
Precautions
1. DO NOT use the 1492VBI to monitor sterilization cycles which it is not designed
to challenge:
a. Gravity-displacement steam sterilization cycles;
b. 250°F (121°C) dynamic-air-removal steam sterilization cycles;
c. Dry heat, chemical vapor, ethylene oxide or other low temperature
sterilization processes.
2. To reduce the risk associated with incorrect results:
• Do not place tape or labels on 1492VBI prior to sterilization or incubation.
• Do not incubate a 1492VBI if, after processing and before BI activation, it
is observed to have a broken media ampoule. Retest the sterilizer with a
new biological indicator.
• After processing, allow BI to cool for 10minutes before incubation.
• After BI activation, ensure media has flowed to the spore growth chamber.
Monitoring Frequency
Follow facility Policies and Procedures which should specify a biological indicator
monitoring frequency compliant with professional association recommended
practices and/or national guidelines and standards. As a best practice and to
provide optimal patient safety, 3M recommends that every steam sterilization load
be monitored with a biological indicator in an appropriate Process Challenge Device
(PCD i.e., BI challenge test pack).
Directions forUse
1. Identify the 1492VBI by writing the load number, sterilizer, and processing
date on the indicator label. Do not place another label or indicator tape on the
vial or on the cap.
2. Place the 1492VBI in a representative tray configuration or Process Challenge
Device (PCD) as recommended by professional association guidelines or
national standards for healthcare facility practice. Do not place the 1492VBI
in direct contact with a chemical indicator as residue could transfer to the
biological indicator and affect the result.
3. Place the PCD in the most challenging area of the sterilizer. This is typically on
the bottom shelf, over the drain, however, the sterilizer manufacturer should be
consulted to identify the area of the chamber least favorable to sterilization.
4. Process the load according to recommended practices.
5. After completion of the cycle take the PCD out of the sterilizer, and remove
the 1492VBI.
6. Allow the 1492VBI to cool for 10minutes prior to activation.
7. Check the process indicator on the top of the cap of the 1492VBI. A color
change from pink to light brown or darker confirms that the 1492VBI has been
exposed to the steam process. This color change does not indicate that the
steam process was sufficient to achieve sterility. If the process indicator is
unchanged, check the sterilizer physical monitors.

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8. To activate the biological
indicator, place it in an Attest™
Biological Indicator Activator.
Close and squeeze the activator
to close the 1492VBI cap and
crush the media ampoule. Then
remove the BI and flick it (see
pictures at right). Visually verify
that media has flowed into the
growth chamber at the bottom of
the vial. If the media hasn’t filled
the growth chamber, hold the BI
by the cap and flick it until media
fills the growth chamber. Place
the activated 1492VBI:
- in any well of a 490or 490H
Auto-reader having software
version 4.0.0orgreater
or
- in an incubation well of a
490Auto-reader having
software version less than
4.0.0which is color-coded
brown (i.e., configured to
incubate 1492VBIs)
and wait for the result. See the
Auto-reader Operator’s Manual
for further information related
to its use.
9. Each day that a processed
1492VBI is incubated, activate
and incubate at least one
non-processed 1492VBI to use
as a positive control. Follow the
activation instructions provided
in Step 8above. Write a "C" (for
"control") and the date on the BI label. The positive control should be from the
same lot code as the processed biological indicator. The positive control BI
helpsconfirm:
• correct incubation temperatures are met,
• 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 the Auto-reader.
10. Incubation and Reading:
Incubate the positive control and steam processed 1492VBIs in a
490Auto-reader or a 490H Auto-reader having software version 4.0.0or
greater. See the Auto-reader Operator’s Manual for the proper use of this
equipment. The Auto-reader will indicate a positive result as soon as it is
obtained. The final negative 1492VBI reading is made at:
- 24minutes in 490or 490H Auto-readers having software version
4.0.0orgreater
- 1hour in 490Auto-readers having software version less than 4.0.0.
After the results are displayed and recorded, the 1492VBIs may be discarded.
Interpretation of Results
Fluorescent Results
The positive control (unprocessed) 1492VBI must provide a positive fluorescent
result (+ on the 490or 490H Auto-reader LCD display). Processed 1492VBI results
are not valid until the positive control reads fluorescent positive. If the positive
control reads negative (- on the LCD display), check the Auto-reader Operator’s
Manual Troubleshooting Guide. Retest the Auto-reader with a new positive control.
With processed 1492VBIs, a positive (+ on the LCD display) result indicates a
sterilization process failure. A final negative processed 1492VBI reading (- on
the LCD display) after the specified incubation time indicates an acceptable
sterilizationprocess.
Act immediately on any positive results for processed BIs. Determine the cause of
the positive BI following facility policies and procedures. Always retest the sterilizer
and do not use sterilizer for processing loads until three consecutive BI results
arenegative.
Optional Visual pH Color Change Result
The 1492VBI is normally discarded after the fluorescent result has been recorded.
If, however, special studies are desired, 1492VBIs may be further incubated for
a visual pH color change result. After activation and during incubation, the white
Nonwoven Material will absorb the bromocresol purple indicator, the pH-sensitive
indicator dye in the growth media, and appear blue. In the case of the positive
control BI a yellow color change of the growth media and/or Nonwoven Material will
appear within 48hours. Any observation of a yellow color within the vial indicates
a positive result.
In the case of a processed 1492VBI, a media and/or Nonwoven Material color
change from purple to yellow indicates a sterilization process failure. A negative pH
color change result, i.e., media and Nonwoven Material remain purple/blue, can be
assessed at 48hours.
2. To reduce the risk associated with incorrect results:
• Do not place tape or labels on 1492VBI prior to sterilization or incubation.
• Do not incubate a 1492VBI if, after processing and before BI activation, it
is observed to have a broken media ampoule. Retest the sterilizer with a
new biological indicator.
• After processing, allow BI to cool for 10minutes before incubation.
• After BI activation, ensure media has flowed to the spore growth chamber.
Monitoring Frequency
Follow facility Policies and Procedures which should specify a biological indicator
monitoring frequency compliant with professional association recommended
practices and/or national guidelines and standards. As a best practice and to
provide optimal patient safety, 3M recommends that every steam sterilization load
be monitored with a biological indicator in an appropriate Process Challenge Device
(PCD i.e., BI challenge test pack).
Directions forUse
1. Identify the 1492VBI by writing the load number, sterilizer, and processing
date on the indicator label. Do not place another label or indicator tape on the
vial or on the cap.
2. Place the 1492VBI in a representative tray configuration or Process Challenge
Device (PCD) as recommended by professional association guidelines or
national standards for healthcare facility practice. Do not place the 1492VBI
in direct contact with a chemical indicator as residue could transfer to the
biological indicator and affect the result.
3. Place the PCD in the most challenging area of the sterilizer. This is typically on
the bottom shelf, over the drain, however, the sterilizer manufacturer should be
consulted to identify the area of the chamber least favorable to sterilization.
4. Process the load according to recommended practices.
5. After completion of the cycle take the PCD out of the sterilizer, and remove
the 1492VBI.
6. Allow the 1492VBI to cool for 10minutes prior to activation.
7. Check the process indicator on the top of the cap of the 1492VBI. A color
change from pink to light brown or darker confirms that the 1492VBI has been
exposed to the steam process. This color change does not indicate that the
steam process was sufficient to achieve sterility. If the process indicator is
unchanged, check the sterilizer physical monitors.

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Storage
• Best stored in the original box under normal room conditions: 59-86ºF
(15-30ºC), 35-60% relative humidity (RH).
• Do not store 1492VBIs near sterilants or other chemicals.
Disposal
Dispose of used 1492VBIs according to your health care facility policy. You may
wish to steam sterilize any positive biological indicators at 132°C (270°F) for
4minutes or at 275°F (135°C) for 3minutes in a dynamic-air-removal steam
sterilizer prior to disposal.
For further information, please contact your local 3M representative or contact us at
3M.com and select your country.
Explanation of Symbols
Catalogue Number
Caution, see instructions for use
Do not reuse
Use by date
Batch code
Manufacturer
Date of manufacture
Product is designed for use with steam sterilizationcycles.
British Standards Institution (BSI) Kitemark™ License for compliance with
BSEN ISO 11138-1:2006and BS EN ISO 11138-3:2009