2
3
a
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 (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 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, CAN/CSA 22.2 No. 61010-1 and CAN/CSA 22.2 No. 61010-2-010.
The 3M™ Attest™ Auto-reader 390 complies with the CE mark related to the Low Voltage
Directive (LVD) 2014/35/EU 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 61326-1:2012/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 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).
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may
cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class A
digital device pursuant to part 15 of the FCC Rules. These limits are designed to provide
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.
Modifications to this device shall not be made without the written consent of 3M
Company. Unauthorized modifications may void the authority granted under Federal
Communication Rules permitting the operation of this device.
CAN ICES-3 (A)/NMB-3(A)
EXPLANATION OF PRODUCT AND PACKAGING
LABEL SYMBOLS
Symbol Glossary
Symbol Title
Symbol
Description and Reference
Manufacturer
Indicates the medical device manufacturer
as defined in Medical Device Regulation (EU)
2017/745 formerly EU Directive 93/42/EEC.
Source: ISO 15223, 5.1.1
Authorized
Representative in
European Community
Indicates the authorized representative in the
European Community. Source: ISO 15223, 5.1.2,
2014/35/EU, and/or 2014/30/EU
Date of Manufacture
Indicates the date when the medical device was
manufactured. Source: ISO 15223, 5.1.3
Catalogue number
Indicates the manufacturer's catalogue number
so that the medical device can be identified.
Source : ISO 15223, 5.1.6
Serial number
Indicates the manufacturer's serial number so
that a specific medical device can be identified.
Source: ISO 15223, 5.1 .7
Caution
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons, be presented
on the medical device itself. Source: ISO 15223,
5.4.4
CE Mark
Indicates conformity to all applicable European
Union Medical Device Regulations and Directives.
UL Listed
Indicates product was evaluated and Listed by UL
for the USA and Canada.
Regulatory
Compliance Mark
Indicates product complies with applicable
Australian regulatory requirements. Source: AS/
NZS 4417.1:2012
Direct current
To indicate on the rating plate that the equipment
is suitable for direct current only or to identify
relevant terminals. Source: IEC 60417-5031
Recycle electronic
equipment
DO NOT throw this unit into a municipal trash bin
when this unit has reached the end of its lifetime.
Please recycle. Source: Directive 2012/19/EC on
waste electrical and electronic equipment (WEEE)
For more information see, HCBGregulatory.3M.com
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.
