Preface; Intended Use; Indications For Use; Product Description - 3M Attest 490H Benutzerhandbuch

PREFACE

Manual Revision History
Date Revision
November, 2013 A
September, 2014 B
April, 2015 C
March, 2017 D
September, 2017 E
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™ Auto‑reader 490H 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 Readout Biological Indicator System for Vaporized Hydrogen
Peroxide Sterilization provides rapid and reliable routine monitoring of vaporized hydrogen
peroxide sterilization processes in health care facilities. The system is comprised of an
incubator/reader with embedded software, the 3M™ Attest™ Auto‑reader 490H, and a
biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator 1295.
3M™ Attest™ Auto‑readers 490H having software version 4.0.0 or greater may also be
used as part of the 3M™ Attest™ Super Rapid Readout Biological Indicator System to
provide rapid, reliable monitoring of steam sterilization processes performed in health
care facilities. This system is comprised of biological indicators, challenge packs, and
incubator/readers (3M™ Attest™ Auto‑reader 490 and 3M Attest™ Auto‑reader 490H)
with embedded software.
INDICATIONS FOR USE
The 3M™ Attest™ Auto‑reader 490H 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.
PRODUCT DESCRIPTION
The 3M™ Attest™ Rapid Readout Biological Indicator System for Vaporized Hydrogen
Peroxide Sterilization provides rapid, reliable routine monitoring of hydrogen peroxide
vapor sterilization processes performed in health care facilities. The system is comprised
of a biological indicator and an incubator/reader (3M™ Attest™ Auto‑reader 490H) with
embedded software. The 3M™ Attest™ Auto‑reader 490H is designed to incubate and
automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 at 60°C for a
final fluorescent result at 24 minutes.
2
Reason for Revision
Initial Issue
To add network switch requirements to the
WebApp section.
Various specification edits/updates.
490H Web App Configuration Page: Added rows
for secondary DNS and MAC address.
BI Activation instructions: added option to
activate 1295 BI using Attest™ BI Activator.
Revised to reflect reduced time for final
fluorescent result. Applicable to 3M™
Attest™ Auto‑reader 490H software version
4.0.0 or greater.
This manual is applicable to 3M™ Attest™
Auto‑readers 490H having software version
4.0.0 or greater and a black incubation
well configuration sticker. Manual revised
to add incubation of 3M™ Attest™ Super
Rapid Readout Biological Indicators, catalog
numbers 1491 and 1492V, in the Model
490H Auto‑reader.
The 3M™ Attest™ Auto‑reader 490H is also designed to allow for further incubation
of positive control 3M™ Attest™ Rapid Readout Biological Indicators 1295 for a final
positive visual pH color change result at 24 hours. It is recommended that processed BIs
be transferred to a humidified incubator for further incubation. A final negative visual pH
color change result is assessed after 7 days. This further incubation is optional and not
intended for routine use.
The 3M™ Attest™ Super Rapid Readout Biological Indicator System provides rapid,
reliable monitoring of steam sterilization processes performed in health care facilities.
The 3M™ Attest™ Auto‑reader 490H having software version 4.0.0 or greater is also
validated 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 490H 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 positive visual pH color change result 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.

WARRANTY

In the US, the 3M™ Attest™ Auto‑reader 490H 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 490H.
Serial Number
For easy identification, each 3M™ Attest™ Auto‑reader 490H 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
your serial number in this manual for future reference: ___________________.
SAFETY AND PRECAUTIONS
The 3M™ Attest™ Auto‑reader 490H 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 490H, the 3M™
Attest™ Rapid Readout Biological Indicator 1295, and 3M™ Attest™ Super Rapid
Readout Biological Indicators 1491 and 1492V prior to use. Use this equipment only
for the purpose described in this 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.
button. Please record