Health And Safety Information; Emc Compliance; Explanation Of Product And Packaging Label Symbols - 3M Attest 490H Benutzerhandbuch

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.
Allow 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V
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 3M™ Attest™ Super Rapid Readout Biological
Indicators 1491 or 1492V.
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.
Activate and incubate 3M™ Attest™ Rapid Readout Biological Indicators 1295 within
1 hour of the completion of the sterilization cycle.
Allow 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V to
cool for the recommended time period before activating.
Do not incubate a 3M™ Attest™ Biological Indicator if, after processing and before BI
activation, it is observed to have a broken media ampoule. Retest the sterilizer with a
new biological indicator.
Incubate the 3M™ Attest™ Rapid Readout Biological Indicator 1295 only in the 3M™
Attest™ Auto‑reader 490H.
Do not remove the 3M™ Attest™ Biological Indicator from the incubation well until
the (+) or (‑) symbol on the LCD Display indicates the test is complete.
Caution: To reduce the risk associated with incorrect results
To avoid the possibility of the 3M™ Attest™ Biological Indicator vial absorbing
fluorescent residue from a chemical indicator or tape, place the 3M™ Attest™
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 490H complies with the following standards as
demonstrated by the CB Scheme Certificate and test report issued by Underwriters
Laboratories (UL):
• IEC 61010‑1 (2010) 3rd Edition. Safety requirements for electrical equipment for
measurement, control, and laboratory use ‑ Part 1: General requirements
• IEC 61010‑2‑010: 2014 3rd 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 490H 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, CAN/CSA C22.2 No. 61010‑1 and CAN/CSA C22.2 No. 61010‑2‑010.
The 3M™ Attest™ Auto‑reader 490H 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 490H 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 490H 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 490H complies with the following EMC standards as
confirmed in the Certificate of Compliance generated by 3M:
• IEC 61326‑1:2012/EN 61326:2013 Electrical equipment for measurement, control
and laboratory use ‑ EMC requirements ‑ Part 1: General requirements
• EMC requirements of the CE mark EMC Directive 2004/108/EC.
The 3M™ Attest™ Auto‑reader 490H 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.
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
contained therein need to be disposed of properly.
Li
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
3