HEALTH AND SAFETY INFORMATION
Device Safety Compliance
The 3M™ Attest™ Auto‑reader 390G complies with the following standards as demonstrated by the CB Scheme Certificate and test report issued by Underwriters Laboratories (UL):
•IEC 61010‑1 (2001) Second Edition. Safety requirements for electrical equipment for measurement, control, and laboratory use ‑ Part 1: General requirements
•IEC 61010‑2‑010 (2003) Second Edition. Safety requirements for electrical equipment for measurement, control, and laboratory use ‑ Part 2‑010: Particular requirements for laboratory equipment for the heating of materials
The 3M™ Attest™ Auto‑reader 390G 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 390G complies with the CE mark related to the Low Voltage Directive (LVD) 2006/95/EC as confirmed in the Declaration of Conformity.
The 3M™ Attest™ Auto‑reader 390G complies with the RoHS Directive, Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
The 3M™ Attest™ Auto‑reader 390G complies with the WEEE Directive, Directive 2012/19/EU of the European Parliament and of the Council of 04 July 2012 on waste electrical and electronic equipment (WEEE).
EMC Compliance
The 3M™ Attest™ Auto‑reader 390G 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 390G complies with the EMC requirements of the CE mark EMC Directive 2004/108/EC.
The 3M™ Attest™ Auto‑reader 390G 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, Subpart B, 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 device meets all requirements of the Canadian Interference‑Causing Equipment Regulations.
Class 1 LED Product
An investigation was conducted on the 3M™ Attest™ Auto‑reader 390G per the requirements of IEC 60825‑1 Ed. 1.2 (A2:2001). The 3M™ Attest™ Auto‑reader 390G is a Class 1 LED product with Class 1 Internal Radiation.
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 390G may be controlled and not to the use of biological indicator controls.
EXPLANATION OF PRODUCT AND PACKAGING LABEL SYMBOLS
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| Attention ‑ Refer to the instructions for use | |
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| Waste Electrical and Electronic Equipment (WEEE) and EU Battery Directive. | |
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| This symbol indicates that both the device and the lithium ion battery | |
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| contained therein need to be disposed of properly. | |
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| UL Listed to US and Canadian Safety Standards | |
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| Mark of Conformity to European Directives | |
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| Direct current | |
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| Compliant to all applicable ACMA regulatory arrangements (RCM) | |
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| Authorized representative for the European Community | |
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| Serial number | |
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| 1294 |
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| The 3M™ Attest™ Auto‑reader 390G is not designed to incubate | |
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| 3M™ Attest™ 1264 EO Biological Indicators, which have a sterilant | |
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| entry port in the center of the top of the cap. The 3M™ Attest™ | |
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| Auto‑reader 390G is designed to incubate and read only 3M™ Attest™ | |
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| Rapid Readout Biological Indicators for EO, catalog number 1294. Other | |
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| biological indicators (BIs) are not compatible with this device and cannot | |
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| be used. | |
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