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PREFACE
Manual Revision History
Date Revision Reason For Revision
SEP 2010 A Initial Issue
FEB 2012 B To include the incubation of 3M™Attest™ Super
Rapid Readout BiologicalIndicators 1492V in the
3M™Attest™Auto‑reader490 and add statements
clarifying access to the 3M™Attest™ Auto‑reader490
Web App within a securenetwork.
JUN 2013 C To revise: the Warranty statement; and the WEEE and
C‑Tick symbols and associated explanatorytext.
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 patient names or testresults.
Hardware Disclaimer
The 3M™Attest™ Auto‑reader490 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 thisdocument.
INTENDED USE
The 3M™Attest™ Super Rapid Readout Biological Indicator System provides rapid,
reliable monitoring of steam sterilization processes performed in health care facilities. The
system is comprised of biological indicators, challenge packs, and an incubator/reader
(3M™Attest™ Auto‑reader490) with embeddedsoftware.
The 3M™Attest™ Auto‑reader490 is designed to incubate and automatically read
3M™Attest™ Super Rapid Readout Biological Indicators 1491 at 56°C for a final
negative fluorescence reading at 30 minutes and 3M™Attest™ Super Rapid Readout
Biological Indicators 1492V at 56°C for a final negative fluorescence reading at 1hour.
The 3M™Attest™ Auto‑reader490 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 routineuse.
A positive fluorescence reading or a visual pH color change indicate a steam sterilization
process failure. However, due to the high sensitivity of the fluorescent result, there is no
advantage to continuing to incubate processed 3M™Attest™ Super Rapid Readout
Biological Indicators once the fluorescent result has beendocumented.
Other biological indicators (BIs) are not compatible with this device and cannot beused.
The unit is designed to be used only with the Power Supply module and Ethernet cable
supplied by3M.
WARRANTY
The 3M™ Attest™ Auto‑reader 490 has a one year limited product warranty. The US
warranty, remedy and limitations are described in the Price Quote form and in the Direct
Price Pages. For countries outside of the US, any warranty is established by the subsidiary
with responsibility for service of the 3M™ Attest™ Auto‑reader 490.
Serial Number
For easy identification, each 3M™Attest™ Auto‑reader490 has a unique serial
number printed on a label (SN / DATE CODE) found on the back of the unit and
displayed on the left side of the upper row of text on the LCD Display when the user
depresses the
button. Please record your serial number in this manual for future
reference:________________________________.
SAFETY AND PRECAUTIONS
The 3M™Attest™ Auto‑reader490 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™ Auto‑reader490 and Super Rapid Readout Biological
Indicator devices prior to use. Use this equipment only for the purpose described in the
Operator’s Manual. Retain these instructions for futurereference.
If this product is used in a manner not specified, the protection provided by the product
may beimpaired.
Explanation of Single Word Consequences
WARNING: Indicates a hazardous situation, which, if not avoided, could result in
death or seriousinjury.
CAUTION: Indicates a hazardous situation, which, if not avoided, could result in
minor or moderateinjury.
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 theinstrument.
WARNING: To reduce the risk associated with hazardous voltage
Use indoorsonly.
Do not use the equipment if it is not working properly or if it has suffered anydamage.
Use only the power supply specified for this product and certified for the country
ofuse.
CAUTION: To reduce the risk of injury or instrumentdamage
Do not spill liquid onto or into the instrument. Do not immerse the unit inliquid.
Always unplug the 3M™Attest™ Auto‑reader490 and allow to cool before cleaning.
Clean external surfaces using only the instructions provided by themanufacturer.
Do not open the instrument housing – there are no user serviceableparts.
The instrument must be returned to the manufacturer forrepair.
Allow the 3M™Attest™ Super Rapid Readout Biological Indicator to cool for the
recommended time period before activating. Activating or excessive handling of the
biological indicator before cooling may cause the glass ampoule toburst.
Wear safety glasses when activating the 3M™Attest™ Super Rapid Readout
BiologicalIndicator.