3M Attest 390 - Preface; Indications for Use; Product Description; Warranty

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PREFACE
Manual RevisionHistory
Date Revision Reason For Revision
October 2012 A Initial Issue
November 2012 B To update Australian EMC statement and symbol
February 2013 C
To clarify, in the Indications for Use section, that
Attest™ 1291and 1292Rapid Readout Biological
Indicators are used to monitor the steam
sterilizationprocess
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 testresults.
Hardware Disclaimer
The 3M™Attest™ Auto-reader390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.
INDICATONS FORUSE
The 3M™Attest™ Auto-reader390is designed to incubate and automatically read
the3M™Attest™ Rapid Readout Biological Indicators for Steam, 1291and 1292, at 60°C
for a final fluorescent result at 1hour for 1291and 3hours for1292.
PRODUCTDESCRIPTION
The 3M™Attest™ 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-reader390) with embeddedsoftware.
The 3M™Attest™ Auto-reader390is designed to incubate and automatically read
3M™Attest™ 1291Rapid Readout Biological Indicators for Steam at 60°C for a final
fluorescence result at 1hour and 3M™Attest™ 1292and 1292E Rapid Readout
Biological Indicators for Steam at 60°C for a final fluorescence result at 3hours. The
3M™Attest™ 1292E Rapid Readout Biological Indicator is not cleared for use in the
UnitedStates.
The 3M™Attest™ Auto-reader390is also designed to allow for further incubation of
3M™Attest™ Rapid Readout Biological Indicators for Steam, catalog numbers 1291and
1292, 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 fluorescence reading or a visual pH color change indicates 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™ Rapid Readout Biological
Indicators once the fluorescent result has beendocumented.
Other biological indicators (BIs) are not compatible with this device and cannot beused.
The unit is designed to be used only with the Power Supply module and Ethernet cable
supplied by3M.
WARRANTY
The 3M™Attest™ Auto-reader390has a limited one year manufacturer’swarranty.
SerialNumber
For easy identification, each 3M™Attest™ Auto-reader390has a unique serial number
printed on a label 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-reader390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-reader390and Rapid Readout Biological
Indicator devices prior to use. Use this equipment only for the purpose described in this
Operator’s Manual. Retain these instructions for futurereference.
If this product is used in a manner not specified, the protection provided by the product
may beimpaired.
Explanation of Single 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™ Auto-reader390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.
The instrument must be returned to the manufacturer for repair.
Allow the 3M™Attest™ 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 to burst.
Wear safety glasses when activating the 3M™Attest™ Rapid Readout
BiologicalIndicator.
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