2
3
1
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.
Do not incubate a 3M™ Attest™ Rapid Readout Biological Indicator 1295 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 i.e., match the pink cap color of the 1295 BI with
the pink color
‑
coded configuration sticker surrounding the 3M™ Attest™ Auto
‑
reader
490H incubation wells.
Do not remove the 3M™ Attest™ Rapid Readout 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™ Rapid Readout Biological Indicator
1295 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 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.
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
Authorized representative for the European Community
Serial number
Li
REF
