Preface; Indications For Use; Warranty; Safety And Precautions - 3M Attest 390G Operator's Manual

PREFACE

Warnings and Safety Precautions
The following warnings and precautions should be followed to avoid unsafe actions that
Manual Revision History
could result in personal injury or damage to the instrument.
Date Revision Reason For Revision
WARNING: To reduce the risk associated with hazardous voltage
November 2012 A Initial Issue
Use indoors only.
To clarify, in the Indications for Use section, that
February 2013 B Attest™ 1294 Biological Indicators are used to
Do not use the equipment if it is not working properly or if it has suffered any damage.
monitor the ethylene oxide sterilization process.
Use only the power supply specified for this product and certified for the country
To revise: the Warranty statement; and the WEEE
July 2013 C of use.
symbol and associated explanatory text.
Content Disclaimers
CAUTION: To reduce the risk of injury or instrument damage
Pictorial Disclaimer
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Sample printouts, graphics, displays and screens are for information and illustration
Always unplug the 3M™ Attest™ Auto-reader 390G and allow to cool before cleaning.
purposes only, and shall not be used for clinical or maintenance evaluations. Data shown
in sample printouts and screens do not reflect actual patient names or test results.
Clean external surfaces using only the instructions provided by the manufacturer.
Hardware Disclaimer
Do not open the instrument housing – there are no user serviceable parts.
The 3M™ Attest™ Auto-reader 390G hardware specifications are subject to change.
The instrument must be returned to the manufacturer for repair.
The system images, hardware components and hardware specifications included in
the manual may not match the system installed. Any changes or modifications to the
Allow the 3M™ Attest™ Rapid Readout Biological Indicator to cool for the
authorized system installation have been verified as compatible with the functionality
recommended time period before activating. Activating or excessive handling of the
outlined in this document.
biological indicator before cooling may cause the glass ampoule to burst.
INDICATIONS FOR USE Wear safety glasses when activating the 3M™ Attest™ Rapid Readout Biological
Indicator.
The 3M™ Attest™ Auto-reader 390G is designed to incubate and automatically read the
3M™ Attest™ Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37°C for a
final fluorescent result at 4 hours.
WARNING: To reduce the risk associated with incorrect results

WARRANTY

Instrument is to be used by operators familiar with the device, device functionality, and
Operator's Manual.
The 3M™ Attest™ Auto-reader 390G has a one year limited product warranty. The US
warranty, remedy and limitations are described in the Price Quote form and in the Direct
Do not place the instrument in environment exposed to sunlight or strong
Price Pages. For countries outside of the US, any warranty is established by the subsidiary
incandescent light.
with responsibility for service of the 3M™ Attest™ Auto-reader 390G.
Do not place instrument close to any device that emits a strong electro-magnetic field.
Serial Number
Do not use on a vibrating surface.
For easy identification, each 3M™ Attest™ Auto-reader 390G has a unique serial number
Match the cap color of the 3M™ Attest™ Rapid Readout Biological Indicator with the
printed on a label found on the back of the unit and displayed on the left side of the upper
color-coded configuration sticker surrounding the 3M™ Attest™ Auto-reader 390G
row of text on the LCD Display when the user depresses the button. Please record incubation wells.
your serial number in this manual for future reference: ___________________.
Do not remove or change placement of 3M™ Attest™ Rapid Readout Biological
Indicator once it is placed into a well.
SAFETY AND PRECAUTIONS
Do not remove the 3M™ Attest™ Rapid Readout Biological Indicator from the
The 3M™ Attest™ Auto-reader 390G and its related devices and accessories are
incubation well until the (+) or (-) symbol on the LCD panel indicates the test
designed to provide safe and reliable service when used according to the instructions
is complete.
provided. Please read, understand, and follow all safety information contained in the
instructions for use included with the 3M™ Attest™ Auto-reader 390G and 1294 Rapid
Readout Biological Indicator devices prior to use. Use this equipment only for the purpose
described in this Operator's Manual. Retain these instructions for future reference.
Caution: To reduce the risk associated with incorrect results
The unit is designed to be used only with the Power Supply module and Ethernet cable
To avoid the possibility of the 3M™ Attest™ Rapid Readout Biological Indicator
supplied by 3M. If this product is used in a manner not specified, the protection provided
vial absorbing fluorescent residue from a chemical indicator or tape, place the
by the product may be impaired.
3M™ Attest™ Rapid Readout Biological Indicator vial so it does not come in direct
contact with chemical indicators or tape.
Explanation of Single Word Consequences
Warning: Indicates a hazardous situation, which, if not avoided, could result in
death or serious injury.
Caution: Indicates a hazardous situation, which, if not avoided, could result in
minor or moderate injury.
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HEALTH AND SAFETY INFORMATION EXPLANATION OF PRODUCT AND PACKAGING
LABEL SYMBOLS
Device Safety Compliance
The 3M™ Attest™ Auto-reader 390G 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
Li
measurement, control, and laboratory use - Part 1: General requirements
• 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 of materials
The 3M™ Attest™ Auto-reader 390G 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 and CAN/CSA 22.2 No. 61010-1.
The 3M™ Attest™ Auto-reader 390G 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 390G complies with the RoHS Directive, Directive
2011/65/EU of the European Parliament and of the Council of 8 June 2011 on
REF
the restriction of the use of certain hazardous substances in electrical and
electronic equipment.
The 3M™ Attest™ Auto-reader 390G 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 390G complies with the following EMC standards as
confirmed in the Certificate of Compliance generated by 3M:
IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC
requirements - Part 1: General requirements
The 3M™ Attest™ Auto-reader 390G complies with the EMC requirements of the CE
mark EMC Directive 2004/108/EC.
The 3M™ Attest™ Auto-reader 390G 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.
Class 1 LED Product
An investigation was conducted on the 3M™ Attest™ Auto-reader 390G per the
requirements of IEC 60825-1 Ed. 1.2 (A2:2001). The 3M™ Attest™ Auto-reader 390G is a
Class 1 LED product with Class 1 Internal Radiation.
The LED apertures are located at the bottom of each Incubator/Reader well perpendicular
to the opening of each well.
NOTE: Class 1 products are safe for unprotected exposure of the eyes.
Caution - Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
Note: The use of the term "controls" in the above caution statement as required by
IEC 60825-1 Ed. 1.2 (A2:2001) refers to mechanisms by which the 3M™ Attest™
Auto-reader 390G may be controlled and not to the use of biological indicator controls.
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
1294
The 3M™ Attest™ Auto-reader 390G is not designed to incubate
3M™ Attest™ 1264 EO Biological Indicators, which have a sterilant
entry port in the center of the top of the cap. The 3M™ Attest™
Auto-reader 390G 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
be used.
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