2 3
1
HEALTH AND SAFETYINFORMATION
Device SafetyCompliance
The 3M™Attest™ Auto‑reader390G 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: Generalrequirements
•
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 ofmaterials
The 3M™Attest™ Auto‑reader390G is listed as Laboratory equipment and carries the
UL mark with adjacent indicators “C” and “US” based on compliance to the standards UL
61010‑1and CAN/CSA 22.2No.61010‑1.
The 3M™Attest™ Auto‑reader390G complies with the CE mark related to the Low
Voltage Directive (LVD) 2006/95/EC as confirmed in the Declaration ofConformity.
The 3M™Attest™ Auto‑reader390G complies with the RoHS Directive, Directive
2011/65/EU of the European Parliament and of the Council of 8June 2011on
the restriction of the use of certain hazardous substances in electrical and
electronicequipment.
The 3M™Attest™ Auto‑reader390G complies with the WEEE Directive, Directive
2012/19/EU of the European Parliament and of the Council of 04July 2012on waste
electrical and electronic equipment(WEEE).
EMCCompliance
The 3M™Attest™ Auto‑reader390G complies with the following EMC standards as
confirmed in the Certificate of Compliance generated by3M:
IEC 61326‑1Electrical equipment for measurement, control and laboratory use ‑ EMC
requirements ‑ Part 1: Generalrequirements
The 3M™Attest™ Auto‑reader390G complies with the EMC requirements of the CE
mark EMC Directive2004/108/EC.
The 3M™Attest™ Auto‑reader390G 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 ComplianceMark).
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 ownexpense.
This Class A digital device meets all requirements of the Canadian Interference‑Causing
EquipmentRegulations.
Class 1LEDProduct
An investigation was conducted on the 3M™Attest™ Auto‑reader390G per the
requirements of IEC 60825‑1Ed. 1.2(A2:2001). The 3M™Attest™ Auto‑reader390G is a
Class 1LED product with Class 1InternalRadiation.
The LED apertures are located at the bottom of each Incubator/Reader well perpendicular
to the opening of eachwell.
NOTE: Class 1products are safe for unprotected exposure of theeyes.
Caution ‑ Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiationexposure.
Note: The use of the term “controls” in the above caution statement as required by
IEC 60825‑1Ed. 1.2(A2:2001) refers to mechanisms by which the 3M™Attest™
Auto‑reader390G may be controlled and not to the use of biological indicatorcontrols.
EXPLANATION OF PRODUCT AND PACKAGING
LABELSYMBOLS
Attention ‑ Refer to the instructions foruse
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 SafetyStandards
Mark of Conformity to EuropeanDirectives
Directcurrent
Compliant to all applicable ACMA regulatory arrangements(RCM)
Manufacturer
Catalognumber
Authorized representative for the EuropeanCommunity
Serialnumber
The 3M™Attest™ Auto‑reader390G is not designed to incubate
3M™Attest™ 1264EO Biological Indicators, which have a sterilant
entry port in the center of the top of the cap. The 3M™Attest™
Auto‑reader390G is designed to incubate and read only 3M™Attest™
Rapid Readout Biological Indicators for EO, catalog number 1294. Other
biological indicators (BIs) are not compatible with this device and cannot
beused.
Li
REF
1294