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™ Super Rapid Readout Biological Indicator with the color‑coded configuration sticker surrounding the 3M™ Attest™ Auto‑reader 490 incubation wells.
Do not remove or change placement of 3M™ Attest™ Super Rapid Readout Biological Indicator once it is placed into a well.
Do not remove the 3M™ Attest™ Super 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™ Super Rapid Readout Biological Indicator vial absorbing fluorescent residue from a chemical indicator or tape, place the 3M™ Attest™ Super Rapid Readout Biological Indicator vial so it does not come in direct contact with chemical indicators or tape.
HEALTH AND SAFETY INFORMATION
Device Safety Compliance
The 3M™ Attest™ Auto‑reader 490 complies with the following standards as demonstrated by the CB Scheme Certificate and test report issued by Underwriters Laboratories (UL):
•IEC 61010‑1 Safety requirements for electrical equipment for measurement, control, and laboratory use ‑ Part 1: General requirements
•IEC 61010‑2‑010 Safety requirements for electrical equipment for measurement, control, and laboratory use ‑ Part 2‑010: Particular requirements for laboratory equipment for the heating of materials
•IEC 60825‑1 First Edition Safety of laser products ‑ Part 1: Equipment classification, requirements, and user’s guide
The 3M™ Attest™ Auto‑reader 490 is listed as Laboratory equipment and carries the UL mark with adjacent indicators “C” and “US” based on compliance to the standards UL 61010‑1 and CAN/CSA 22.2 No. 61010‑1.
The 3M™ Attest™ Auto‑reader 490 complies with the CE mark related to the Low Voltage Directive 73/23/EEC as confirmed in the Declaration of Conformity.
The 3M™ Attest™ Auto‑reader 490 complies with the RoHS Directive, Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
EMC Compliance
The 3M™ Attest™ Auto‑reader 490 complies with the following EMC standards as confirmed in the Certificate of Compliance generated by 3M:
IEC 61326‑1 Electrical equipment for measurement, control and laboratory use ‑ EMC requirements ‑ Part 1: General requirements
The 3M™ Attest™ Auto‑reader 490 complies with the EMC requirements of the CE mark EMC Directive 2004/108/EC.
The 3M™ Attest™ Auto‑reader 490 complies with the Australian and New Zealand electrical safety and electromagnetic compatibility requirements as confirmed in the Supplier’s Declaration of Conformity that is linked to the Australian/New Zealand RCM (Regulatory Compliance Mark).
Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide a reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their own expense.
This Class A digital apparatus meets all requirements of the Canadian Interference‑Causing Equipment Regulations.
Class 1 LED Product
An investigation was conducted on the 3M™ Attest™ Auto‑reader 490 per the requirements of IEC 60825‑1 Ed. 1.2 (A2:2001). The 3M™ Attest™ Auto‑reader 490 is a Class 1 LED product with Class 1 Internal Radiation. The magnitude of the maximum radiant power is 5.25uW.
The LED apertures are located at the bottom of each Incubator/Reader well perpendicular to the opening of each well.
Note: Class 1 products are safe for unprotected exposure of the eyes.
Caution ‑ Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
Note: The use of the term “controls” in the above caution statement as required by IEC 60825‑1 Ed. 1.2 (A2:2001) refers to mechanisms by which the 3M™ Attest™ Auto‑reader 490 may be controlled and not to the use of biological indicator controls.
EXPLANATION OF PRODUCT AND PACKAGING LABEL SYMBOLS
Attention ‑ Refer to the instructions for use
| Waste Electrical and Electronic Equipment (WEEE) and EU Battery Directive. |
| This symbol indicates that both the device and the lithium ion battery |
Li | contained therein need to be disposed of properly. |
| |
| UL Listed to US and Canadian Safety Standards |
Mark of Conformity to European Directives
Direct current
Compliant to all applicable ACMA regulatory arrangements (RCM)
Manufacturer – This symbol is accompanied by name and address of the manufacturer.
Catalog – This symbol is accompanied by the catalog number relevant to the device bearing the symbol.
Authorized representative for the European Community – This symbol is accompanied by the name and the address of the authorized representative in the European Community.
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