Preface; Intended Use; Indications For Use; Warranty - 3M Attest Auto-reader 490 Benutzerhandbuch

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.
SEP 2017 D This manual is applicable to 3M™ Attest™
Auto-readers 490 having software version 4.0.0 or
greater and a black incubation well configuration
sticker. Revised to: reflect reduced time for final
fluorescent result; add various compliance revisions; and
add rows for secondary DNS and MAC address to 490 Web
App Configuration Page.
FEB 2018 E Manual revised to add: incubation of Attest™ Rapid
Readout Biological Indicators for Vaporized Hydrogen
Peroxide Sterilization 1295 in 3M™ Attest™ Auto-readers
490 having software version 4.0.0 or greater; and option
to disable the 490 Web App.
AUG 2018 F Manual revised to add Date of Manufacture symbol and
correct typos.
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 incubator/readers
(3M™ Attest™ Auto‑reader 490 and 3M Attest™ Auto‑reader 490H having software
version 4.0.0 or greater) with embedded software.
The 3M™ Attest™ Auto‑reader 490 having software version 4.0.0 or greater is
designed to incubate and automatically read 3M™ Attest™ Super Rapid Readout
Biological Indicators 1491 and 1492V at 60°C for a final negative fluorescence reading
at 24 minutes. 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.
3M™ Attest™ Auto-readers 490 having software version 4.0.0 or greater may also
be used as part of the 3M™ Attest™ Rapid Readout Biological Indicator System for
Vaporized Hydrogen Peroxide Sterilization to provide rapid and reliable routine monitoring
of vaporized hydrogen peroxide sterilization processes in health care facilities. This system
is comprised of incubator/readers (3M™ Attest™ Auto-reader 490 having software
version 4.0.0 or greater and 3M Attest™ Auto-reader 490H) with embedded software,
and a biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator 1295. The
3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater is designed to
incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295
at 60°C for a final negative fluorescence reading at 24 minutes.
2
A positive fluorescence reading 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™ Auto reader 490 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.

WARRANTY

In the US, 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 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 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, the 3M™ Attest™ Rapid Readout
Biological Indicator 1295, and 3M™ Attest™ Super Rapid Readout Biological Indicators
1491 and 1492V devices 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 Ethernet cable
supplied by 3M. If this product is used in a manner not specified, 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.