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 Biological Indicators 1492V in the |
| | 3M™ Attest™ Auto‑reader 490 and add statements |
| | clarifying access to the 3M™ Attest™ Auto‑reader 490 |
| | Web App within a secure network. |
| | |
JUN 2013 | C | To revise: the Warranty statement; and the WEEE and |
| | C-Tick symbols and associated explanatory text. |
| | |
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 490 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™ 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‑reader 490) with embedded software.
The 3M™ Attest™ Auto‑reader 490 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 1 hour.
The 3M™ Attest™ Auto‑reader 490 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 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 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 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‑reader 490 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: ________________________________.
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SAFETY AND PRECAUTIONS
The 3M™ Attest™ Auto‑reader 490 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 490 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 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 490 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™ 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 to burst.
Wear safety glasses when activating the 3M™ Attest™ Super Rapid Readout Biological Indicator.