Health And Safety Information; Emc Compliance; Explanation Of Product And Packaging Label Symbols; Symbol Glossary - 3M VH202 Manuel De L'utilisateur

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™ 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.
Allow 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V to
cool for the recommended time period before activating.
Do not remove or change placement of 3M™ Attest™ Biological Indicator once it is
placed into a well.
Do not remove the 3M™ Attest™ Biological Indicator from the incubation well until the
(+) or (-) symbol on the LCD panel indicates the test is complete.
Do not re-incubate 3M™ Attest™ Biological Indicators for which the 3M™ Attest™
Auto-reader 490 has already determined a result.
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 490 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 490 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 490 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 490 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 490 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 490 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 2014/30/EU.
The 3M™ Attest™ Auto-reader 490 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
Indicates the medical device manufacturer as defined
Manufacturer in Medical Device Regulation (EU) 2017/745 formerly
EU Directive 93/42/EEC. Source: ISO 15223, 5.1.1
Authorized
Indicates the authorized representative in the
Representative
European Community. Source: ISO 15223, 5.1.2,
in European
2014/35/EU, and/or 2014/30/EU
Community
Date of Indicates the date when the medical device was
Manufacture manufactured. Source: ISO 15223, 5.1.3
Indicates the manufacturer's catalogue number so
Catalogue
that the medical device can be identified. Source : ISO
number
15223, 5.1.6
Indicates the manufacturer's serial number so that a
Serial number specific medical device can be identified. Source: ISO
15223, 5.1 .7
Indicates the need for the user to consult the
instructions for use for important cautionary
Caution 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
Indicates conformity to all applicable European Union
CE Mark
Medical Device Regulations and Directives.
Indicates product was evaluated and Listed by UL for
UL Listed
the USA and Canada.
Regulatory Indicates product complies with applicable Australian
Compliance Mark regulatory requirements. Source: AS/NZS 4417.1:2012
To indicate on the rating plate that the equipment is
Direct current suitable for direct current only or to identify relevant
terminals. Source: IEC 60417-5031
DO NOT throw this unit into a municipal trash bin
Recycle
when this unit has reached the end of its lifetime.
electronic
Please recycle. Source: Directive 2012/19/EC on
equipment
waste electrical and electronic equipment (WEEE)
For more information see, HCBGregulatory.3M.com
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