3M Attest 1492V - Product Description; Readout Times; 24-minute Fluorescent Result; 1-hour Fluorescent Result

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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
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02.21.18 PU file from 4614439, update GB to new Doc & insert FPO GB Copy for each language kmh
03.07.18 Collect InDesign files to be sent for translations kmh
05.04.18 Review document from translator, updated fonts for the Asian languages. Jer
05.14.18 Alts per marked up PDF kmh
05.17.18 Final release. TN