3M 490 User Manual

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3M 490 User Manual

3MAttestAuto-reader 490

1 Operator’s Manual

- Manual do Utilizador

2 Manuel de l’utilisateur

- Manual do Operador

3 Benutzerhandbuch

= Εγχειρίδιο Χειριστή

4 Manuale dell’operatore

H Instrukcja obsługi

5 Manual del usuario

F Příručka pro obsluhu

5 Manual del operador

S Priročnik za uporabo

6 Bedieningshandleiding

M Инструкция по эксплуатации

7 Användarhandbok

A Upute za korištenje

8 Brugsvejledning

: Operatör Kılavuzu

9 Brukerhåndbok

I

0 Käyttöopas

 

T

3M™ Attest™ Auto reader 490

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Read and understand all safety information before using this product.

 

TABLE OF CONTENTS

 

 

 

Preface .........................................

2

Intended Use ................................

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 490 Web App

 

9

Troubleshooting the 3M™ Attest™ Auto reader 490 Web App

 

12

Repair and Replacement

 

 

12

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PREFACE

Manual Revision History

Date

Revision

Reason For Revision

 

 

 

SEP 2010

A

Initial Issue

 

 

 

FEB 2012

B

To include the incubation of 3M™ Attest™ Super

 

 

Rapid Readout Biological Indicators 1492V in the

 

 

3M™ Attest™ Auto reader 490 and add statements

 

 

clarifying access to the 3M™ Attest™ Auto reader 490

 

 

Web App within a secure network.

 

 

 

JUN 2013

C

To revise: the Warranty statement; and the WEEE and

 

 

C-Tick symbols and associated explanatory text.

 

 

 

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 490 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.

INTENDED USE

The 3M™ Attest™ Super 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 490) with embedded software.

The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 at 56°C for a final negative fluorescence reading at 30 minutes and 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V at 56°C for a final negative fluorescence reading at 1 hour.

The 3M™ Attest™ Auto reader 490 is also designed to allow for further incubation of 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, 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 indicate 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™ Super 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 490 has a one year limited product warranty. The US warranty, remedy and limitations are described in the Price Quote form and in the Direct Price Pages. For countries outside of the US, any warranty is established by the subsidiary with responsibility for service of the 3M™ Attest™ Auto-reader 490.

Serial Number

For easy identification, each 3M™ Attest™ Auto reader 490 has a unique serial number printed on a label (SN / DATE CODE) 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: ________________________________.

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SAFETY AND PRECAUTIONS

The 3M™ Attest™ Auto reader 490 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 490 and Super Rapid Readout Biological Indicator devices prior to use. Use this equipment only for the purpose described in the 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 490 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™ Super 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™ Super Rapid Readout Biological Indicator.

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™ Super Rapid Readout Biological Indicator with the color coded configuration sticker surrounding the 3M™ Attest™ Auto reader 490 incubation wells.

Do not remove or change placement of 3M™ Attest™ Super Rapid Readout Biological Indicator once it is placed into a well.

Do not remove the 3M™ Attest™ Super 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™ Super Rapid Readout Biological Indicator vial absorbing fluorescent residue from a chemical indicator or tape, place the

3M™ Attest™ Super 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 490 complies with the following standards as demonstrated by the CB Scheme Certificate and test report issued by Underwriters Laboratories (UL):

IEC 61010 1 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements

IEC 61010 2 010 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2 010: Particular requirements for laboratory equipment for the heating of materials

IEC 60825 1 First Edition Safety of laser products Part 1: Equipment classification, requirements, and user’s guide

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 and CAN/CSA 22.2 No. 61010 1.

The 3M™ Attest™ Auto reader 490 complies with the CE mark related to the Low Voltage Directive 73/23/EEC as confirmed in the Declaration of Conformity.

The 3M™ Attest™ Auto reader 490 complies with the RoHS Directive, Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

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 Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements

The 3M™ Attest™ Auto reader 490 complies with the EMC requirements of the CE mark EMC Directive 2004/108/EC.

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).

Note: 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 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 apparatus meets all requirements of the Canadian Interference Causing Equipment Regulations.

Class 1 LED Product

An investigation was conducted on the 3M™ Attest™ Auto reader 490 per the requirements of IEC 60825 1 Ed. 1.2 (A2:2001). The 3M™ Attest™ Auto reader 490 is a Class 1 LED product with Class 1 Internal Radiation. The magnitude of the maximum radiant power is 5.25uW.

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 490 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) and EU Battery Directive.

 

 

 

 

 

 

This symbol indicates that both the device and the lithium ion battery

 

 

 

 

 

 

contained therein need to be disposed of properly.

 

Li

 

 

 

 

 

 

 

 

 

 

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 – This symbol is accompanied by name and address of

 

 

 

 

 

 

the manufacturer.

 

 

 

 

 

 

Catalog – This symbol is accompanied by the catalog number relevant to

 

 

 

 

 

 

the device bearing the symbol.

 

 

 

 

 

 

Authorized representative for the European Community – This symbol is

 

 

 

 

 

 

 

 

 

 

 

 

accompanied by the name and the address of the authorized representative

 

 

 

 

 

 

 

 

 

 

 

 

in the European Community.

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1

SPECIFICATIONS

Power Supply Specifications

Power supply

Operating Condition

Units

Voltage Range

100 240

Volts AC

Frequency

50/60

Hertz

Current

0.6

Amps

Environmental Operating Conditions

Environmental Condition

Operating Condition

Units

Altitude

3000 (max)

Meters

Operating Temperature

16 – 40

ºC

Storage Temperature

10 to 50

ºC

Operating Relative Humidity

20 80 (non condensing)

%

Voltage Range

12

Volts DC

Frequency

DC

 

Current

1.2

Amps

Installation/Over Voltage

Category II

 

Pollution Degree

2

 

INSTRUCTIONS FOR USE – Initial Set up

Choose Location

Place 3M™ Attest™ Auto reader 490 on a firm level surface away from sunlight and incandescent light. To save counter space, units may be stacked two high.

Select & Install Correct Power Plug

The 3M™ Attest™ Auto reader 490 power supply comes with multiple blade configurations. Install the blade configuration appropriate for your country into the power supply and plug into appropriate AC grounded outlet.

WARNING:

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.

WARNING: Use only the power supply specified for this product and certified for the country of use.

Wait 30 Minutes Before Using

Once plugged in, allow a 30 minute warm up period before placing 3M™ Attest™ Super Rapid Readout Biological Indicators into the incubation wells. The C1 caution code will disappear when proper incubation temperature is reached.

Special Considerations

It is recommended that the unit be left on to eliminate warm up periods. The unit may be turned off when it is anticipated that it will not be used for an extended period.

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