Health And Safety Information; Emc Compliance; Explanation Of Product And Packaging Label Symbols - 3M Attest Auto-reader 390 Benutzerhandbuch

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 390 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.
HEALTH AND SAFETY INFORMATION
Device Safety Compliance
The 3M™ Attest™ Auto-reader 390 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 390 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 390 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 390 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 390 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 390 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 390 complies with the EMC requirements of the CE mark
EMC Directive 2004/108/EC.
The 3M™ Attest™ Auto-reader 390 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).
Rendered on 5/8/2013 10:56:36 AM
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 390 per the
requirements of IEC 60825-1 Ed. 1.2 (A2:2001). The 3M™ Attest™ Auto-reader 390 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 390 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)
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
Catalog number
REF
Authorized representative for the European Community
Serial number
The 3M™ Attest™ Auto-reader 390 is not designed to incubate
3M™ Attest™ 1261 and 1262 Steam Biological Indicators, which have
a steam entry port in the center of the top of the cap. The 3M™ Attest™
Auto-reader 390 is designed to incubate and read 3M™ Attest™
Rapid Readout Biological Indicators for Steam, catalog numbers
1291, 1292, and 1292E.
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