1
PREFACE
Manual Revision History
Date | Revision | Reason For Revision | |
|
|
| |
November 2012 | A | Initial Issue | |
|
|
| |
|
| To clarify, in the Indications for Use section, that | |
February 2013 | B | Attest™ 1294 Biological Indicators are used to | |
|
| monitor the ethylene oxide sterilization process. | |
|
|
| |
July 2013 | C | To revise: the Warranty statement; and the WEEE | |
symbol 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 390G 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.
INDICATIONS FOR USE
The 3M™ Attest™ Auto‑reader 390G is designed to incubate and automatically read the 3M™ Attest™ Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37°C for a final fluorescent result at 4 hours.
WARRANTY
The 3M™ Attest™ Auto‑reader 390G 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 390G.
Serial Number
For easy identification, each 3M™ Attest™ Auto‑reader 390G 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 390G 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 390G and 1294 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.
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 390G 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.
WARNING: To reduce the risk associated with incorrect results
Instrument is to be used by operators familiar with the device, device functionality, and Operator’s Manual.
Do not place the instrument in environment exposed to sunlight or strong incandescent light.
Do not place instrument close to any device that emits a strong electro‑magnetic field.
Do not use on a vibrating surface.
Match the cap color of the 3M™ Attest™ Rapid Readout Biological Indicator with the color‑coded configuration sticker surrounding the 3M™ Attest™ Auto‑reader 390G incubation wells.
Do not remove or change placement of 3M™ Attest™ Rapid Readout Biological Indicator once it is placed into a well.
Do not remove the 3M™ Attest™ Rapid Readout Biological Indicator from the incubation well until the (+) or (‑) symbol on the LCD panel indicates the test is complete.
Caution: To reduce the risk associated with incorrect results
To avoid the possibility of the 3M™ Attest™ Rapid Readout Biological Indicator vial absorbing fluorescent residue from a chemical indicator or tape, place the 3M™ Attest™ Rapid Readout Biological Indicator vial so it does not come in direct contact with chemical indicators or tape.
2