3M Attest 390 User manual

3M™Attest™Auto-reader 390
1 Operator’s Manual
2 Manuel de l’utilisateur
3 Benutzerhandbuch
4 Manuale dell’operatore
5 Manual del usuario
5 Manual del operador
6 Bedieningshandleiding
7 Användarhandbok
8 Brugsvejledning
9 Brukerhåndbok
0 Käyttöopas
- Manual do Utilizador
- Manual do Operador
= Εγχειρίδιο Χειριστή
H Instrukcja obsługi
F Příručka pro obsluhu
S Priročnik za uporabo
M Инструкция по эксплуатации
A Upute za korištenje
: Operatör Kılavuzu
I 操作指南
• คู่มือปฏิบัติงาน
T 작업자 매뉴얼
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MECHANICAL ART
DESC: 3M™ Attest™ - Auto-reader 390 - Insert Printed Colors-Front: 1
K
Item Spec. #:
34-8712-0285-8
Supersedes #:
Structure #:
SS-55991
Reference:
Requesters:
Scott Keppers
DIE #:
8.5" x 11"
DATE CHANGES INT.
03.27.13 New Build SRW
04.04.13 Copy Updates. Updated Screens SRW
04.10.13 Updates to Screens SRW
04.19.13 Update Screen Shots & Copy SRW
04.28.13 Copy Updates. SRW
05.02.13 Final Release KMH
SGS#: 3589648 FILE: 01_GB-34871202858_Ins.indd PDF Scaled to 75%
Printed Colors-Back: 1
K
Match Colors: 0
Notes to Printer:
Bar Code
Magnification:
XXX%
This bar code symbol was produced using a bar width adjustment of minus 0.004. If this does not
meet the needs of the printing process or equipment to be used, the printer is responsible to recreate
the file using the appropriate bar width adjustment while meeting 3M quality requirements.
Because of the differences in scanning equipment, SGS Minnesota cannot guarantee the scannability
of UPC Bar codes. The Uniform Code Council recommends a UPC symbol be printed black on white
at 100% with no truncation. All UPC codes are test scanned and verified before leaving our facility.
Special Instructions:
Created in Adobe InDesign CS5
Proof prepared for 3M Company
REV. 05
9300 WINNETKA AVE N, BROOKLYN PARK, MN 55445, 763.488.5700
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3M™Attest™ Auto-reader390 1
Read and understand all safety information before using thisproduct.
TABLE OF CONTENTS
Preface .......................................................................................................................................................................2
Indications for Use.....................................................................................................................................................2
Product Description...................................................................................................................................................2
Warranty.....................................................................................................................................................................2
Safety and Precautions .............................................................................................................................................2
Health and Safety Information..................................................................................................................................3
Explanation of Product and Packaging Label Symbols ..........................................................................................3
Specifications ............................................................................................................................................................4
Instructions for Use...................................................................................................................................................4
Features......................................................................................................................................................................7
Care and Cleaning .....................................................................................................................................................8
Troubleshooting Guide...............................................................................................................................................8
Optional 3M™ Attest™ Auto-reader 390 Web App.................................................................................................9
Troubleshooting the 3M™ Attest™ Auto-reader 390 Web App ...........................................................................12
Repair and Replacement.........................................................................................................................................12
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PREFACE
Manual RevisionHistory
Date Revision Reason For Revision
October 2012 A Initial Issue
November 2012 B To update Australian EMC statement and symbol
February 2013 C
To clarify, in the Indications for Use section, that
Attest™ 1291and 1292Rapid Readout Biological
Indicators are used to monitor the steam
sterilizationprocess
ContentDisclaimers
PictorialDisclaimer
Sample printouts, graphics, displays and screens are for information and illustration
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.
Hardware Disclaimer
The 3M™Attest™ Auto-reader390hardware specifications are subject to change.
The system images, hardware components and hardware specifications included in
the manual may not match the system installed. Any changes or modifications to the
authorized system installation have been verified as compatible with the functionality
outlined in thisdocument.
INDICATONS FORUSE
The 3M™Attest™ Auto-reader390is designed to incubate and automatically read
the3M™Attest™ Rapid Readout Biological Indicators for Steam, 1291and 1292, at 60°C
for a final fluorescent result at 1hour for 1291and 3hours for1292.
PRODUCTDESCRIPTION
The 3M™Attest™ Rapid Readout Biological Indicator System provides rapid, reliable
monitoring of steam sterilization processes performed in health care facilities. The
system is comprised of biological indicators, challenge packs, and an incubator/reader
(3M™Attest™ Auto-reader390) with embeddedsoftware.
The 3M™Attest™ Auto-reader390is designed to incubate and automatically read
3M™Attest™ 1291Rapid Readout Biological Indicators for Steam at 60°C for a final
fluorescence result at 1hour and 3M™Attest™ 1292and 1292E Rapid Readout
Biological Indicators for Steam at 60°C for a final fluorescence result at 3hours. The
3M™Attest™ 1292E Rapid Readout Biological Indicator is not cleared for use in the
UnitedStates.
The 3M™Attest™ Auto-reader390is also designed to allow for further incubation of
3M™Attest™ Rapid Readout Biological Indicators for Steam, catalog numbers 1291and
1292, for a final negative visual pH color change result at 24hours and 48hours,
respectively. This further incubation is optional and not intended for routineuse.
A positive fluorescence reading or a visual pH color change indicates a steam sterilization
process failure. However, due to the high sensitivity of the fluorescent result, there is no
advantage to continuing to incubate processed 3M™Attest™ Rapid Readout Biological
Indicators once the fluorescent result has beendocumented.
Other biological indicators (BIs) are not compatible with this device and cannot beused.
The unit is designed to be used only with the Power Supply module and Ethernet cable
supplied by3M.
WARRANTY
The 3M™Attest™ Auto-reader390has a limited one year manufacturer’swarranty.
SerialNumber
For easy identification, each 3M™Attest™ Auto-reader390has a unique serial number
printed on a label found on the back of the unit and displayed on the left side of the upper
row of text on the LCD Display when the user depresses the button. Please record
your serial number in this manual for future reference:___________________.
SAFETY ANDPRECAUTIONS
The 3M™Attest™ Auto-reader390and its related devices and accessories are designed
to provide safe and reliable service when used according to the instructions provided.
Please read, understand, and follow all safety information contained in the instructions
for use included with the 3M™Attest™ Auto-reader390and 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.
If this product is used in a manner not specified, the protection provided by the product
may beimpaired.
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.
Warnings and SafetyPrecautions
The following warnings and precautions should be followed to avoid unsafe actions that
could result in personal injury or damage to theinstrument.
WARNING: To reduce the risk associated with hazardous voltage
Use indoors only.
Do not use the equipment if it is not working properly or if it has suffered any damage.
Use only the power supply specified for this product and certified for the country
ofuse.
CAUTION: To reduce the risk of injury or instrument damage
Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid.
Always unplug the 3M™Attest™ Auto-reader390and allow to cool before cleaning.
Clean external surfaces using only the instructions provided by the manufacturer.
Do not open the instrument housing – there are no user serviceable parts.
The instrument must be returned to the manufacturer for repair.
Allow the 3M™Attest™ Rapid Readout Biological Indicator to cool for the
recommended time period before activating. Activating or excessive handling of the
biological indicator before cooling may cause the glass ampoule to burst.
Wear safety glasses when activating the 3M™Attest™ Rapid Readout
BiologicalIndicator.
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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(2001) Second Edition. Safety requirements for electrical equipment for
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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and CAN/CSA 22.2No.61010-1.
The 3M™Attest™ Auto-reader390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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Electrical equipment for measurement, control and laboratory use -
EMCrequirements - Part 1: Generalrequirements
The 3M™Attest™ Auto-reader390complies with the 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).
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390per the
requirements of IEC 60825-1Ed. 1.2(A2:2001).The 3M™Attest™ Auto-reader390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390may be controlled and not to the use of biological indicatorcontrols.
EXPLANATION OF PRODUCT AND PACKAGING
LABELSYMBOLS
Attention - Refer to the instructions foruse
Waste Electrical and Electronic Equipment(WEEE)
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
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.
REF
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