3M Attest Auto-reader 490H - Preface; Content Disclaimers; Hardware Disclaimer; Intended Use

2 3
1
PREFACE
Manual RevisionHistory
Date Revision Reason for Revision
November, 2013 A Initial Issue
September, 2014 B
To add network switch requirements to the
WebApp section.
April, 2015 C
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.
March, 2017 D
Revised to reflect reduced time for final
fluorescent result. Applicable to 3M™
Attest™ Auto-reader 490H software version
4.0.0 or greater.
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.
INDICATIONS FORUSE
The 3M™ Attest™ Auto‑reader 490H is designed to incubate and automatically read the
3M™ Attest™ Rapid Readout Biological Indicator 1295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.
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.
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™ Rapid Readout
Biological Indicators 1295once the fluorescent result has beendocumented.
Other biological indicators (BIs) are not compatible with this device and cannot beused.
WARRANTY
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 button. Please record
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 and the
3M™ Attest™ Rapid Readout Biological Indicator 1295devices 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 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 490H 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.
Wear safety glasses and gloves when activating the 3M™ Attest™ Rapid
ReadoutBiological Indicator 1295.