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PREFACE
Content Disclaimers
Pictorial Disclaimer
Sample printouts, graphics, displays and screens are for information and illustration
purposes only and shall not be used for clinical or maintenance evaluations. Data
shown in sample printouts and screens do not reflect actual test results.
Hardware Disclaimer
The 3M™ Attest™ Mini Auto-reader 490M hardware specifications are subject to
change. The system images, hardware components and hardware specifications
included in the manual may not match the system installed. Any changes or
modifications to the authorized system installation have been verified as compatible
with the functionality outlined in this document.
INTENDED USE
The 3M™ Attest™ Rapid Biological Indicator System provides rapid, reliable
monitoring of steam and vaporized hydrogen peroxide sterilization processes
performed in health care facilities. The system is comprised of biological indicators,
challenge packs, and incubator/readers.
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and
automatically read 3M™ Attest™ Biological Indicators 1295, 1491, and 1492V at
60°C for a final negative fluorescence reading at 24 minutes. The 3M™ Attest™
Mini Auto-reader 490M is also designed to allow for further incubation of
3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and
1492V, for a final negative, visual pH color change result at 24 hours and 48 hours,
respectively. This further incubation is optional and not intended for routine use.
A positive fluorescent result or a visual pH color change indicate a sterilization
process failure. However, due to the high sensitivity of the fluorescent result, there
is no advantage to continuing to incubate processed 3M™ Attest™ Biological
Indicators once the fluorescent result has been documented.
Other biological indicators (BIs) are not compatible with this device and cannot be
used.
INDICATIONS FOR USE
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and
automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and
3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and
1492V, at 60°C for a final fluorescent result at 24 minutes.
The indications for use for Attest™ Biological Indicators are provided in the product’s
Instructions for Use.
WARRANTY
In the US, the 3M™ Attest™ Mini Auto-reader 490M has a one-year limited product
warranty. The US warranty, remedy and limitations are described on the product
webpage at Go.3M.com/490M. For countries outside of the US, any warranty is
established by the subsidiary with responsibility for sales of the 3M™ Attest™ Mini
Auto-reader 490M.
Register your device at Go.3M.com/490M.
SAFETY AND PRECAUTIONS
The 3M™ Attest™ Mini Auto-reader 490M and its related devices and accessories
are designed to provide safe and reliable service when used according to the
instructions provided. Please read, understand, and follow all safety information
contained in the instructions for use included with the 3M™ Attest™ Mini
Auto-reader 490M and the associated Attest™ biological indicators prior to use.
Use this equipment only for the purpose described in the Operator’s Manual. Retain
these instructions for future reference.
The unit is designed to be used only with the Power Supply module and USB
cable supplied by 3M. If this product is used in a manner not specified by 3M, the
protection provided by the product may be impaired.
Explanation of Signal Word Consequences
WARNING: Indicates a hazardous situation, which, if not avoided, could
result in death or serious injury.
CAUTION: Indicates a hazardous situation, which, if not avoided, could
result in minor or moderate injury.
Warnings and Safety Precautions
The following warnings and precautions should be followed to avoid unsafe actions
that could result in personal injury or damage to the instrument.
WARNING: To reduce the risk associated with hazardous voltage
Use indoors only.
Do not use the equipment if it is not working properly or if it has suffered any
damage.
Use only the power supply specified for this product and certified for the country
of use.
CAUTION: To reduce the risk of injury or instrument damage
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Always unplug the 3M™ Attest™ Mini Auto-reader 490M and allow to cool
before cleaning.
Clean external surfaces using only the instructions provided by
the manufacturer.
Do not open the instrument housing – there are no user-serviceable parts.
Wear safety glasses and gloves when activating the 3M™ Attest™ Rapid
Readout Biological Indicator 1295.
Allow steam-processed 3M™ Attest™ Biological Indicators to cool for the
recommended time period before activating. Activating or excessive handling
of the biological indicator before cooling may cause the glass media ampoule
to burst.
Wear safety glasses when activating 3M™ Attest™ Super Rapid Biological
Indicators.
WARNING: To reduce the risk associated with incorrect results
Instrument is to be used by operators familiar with the device, device
functionality, and Operator’s Manual.
Do not place the instrument in environment exposed to sunlight or strong
incandescent light.
Do not place instrument close to any device that emits a strong
electro-magnetic field.
Do not use on a vibrating surface.
Activate and incubate 3M™ Attest™ Rapid Readout Biological Indicators
1295 within 1 hour of the completion of the sterilization cycle.
Do not incubate a 3M™ Attest™ Biological Indicator if, after processing and
before BI activation, it is observed to have a broken media ampoule. Retest the
sterilizer with a new biological indicator.
Allow steam-processed 3M™ Attest™ Biological Indicators to cool for the
recommended time period before activating.
Do not remove or change placement of 3M™ Attest™ Biological Indicator once it
is placed into a well.
Do not remove the 3M™ Attest™ Biological Indicator from the incubation well
until the (+) or (-) symbol on the display indicates the test is complete.
Do not re-incubate 3M™ Attest™ Biological Indicators for which the Auto-reader
has already determined a result.
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