3M Attest Auto-reader 390 Operators Manual rev 7 April 2020

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PREFACE 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.

WARRANTY

In the US, the 3M™ Attest™ Auto-reader 390 has a limited one-year manufacturer’s 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 390.

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.

SAFETY AND PRECAUTIONS

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.

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.

PRODUCT DESCRIPTION

If this product is used in a manner not specified, the protection provided by the product may be impaired.

INDICATONS FOR USE

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.

Explanation of Signal 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.

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

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.

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

HEALTH AND SAFETY INFORMATION

Date of Manufacture

Indicates the date when the medical device was manufactured. Source: ISO 15223, 5.1.3

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):

Catalogue number

Indicates the manufacturer's catalogue number so that the medical device can be identified. Source : ISO 15223, 5.1.6

• 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

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

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.

CE Mark

Indicates conformity to all applicable European Union Medical Device Regulations and Directives.

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.

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

Caution: To reduce the risk associated with incorrect results

Device Safety Compliance

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 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

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(2) this device must accept any interference received, including interference that may cause undesired operation.

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 Recycle electronic equipment

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. 3

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SPECIFICATIONS Power Supply Specifications Power supply Voltage Range

Operating Condition 100-240

Units Volts AC

Frequency

50/60

Hertz

Current

0.6

Amps

Environmental Operating Conditions Environmental Condition Altitude

Operating Condition 3000 (max)

Units Meters

Operating Temperature

16 – 40

ºC

Storage Temperature

-10 to 50

ºC

Operating Relative Humidity

20-80 (non-condensing) %

Voltage Range

12

Frequency

DC

Current

1.2

Installation/Over Voltage

Category II

Pollution Degree

2

Volts DC Amps

INSTRUCTIONS FOR USE – Initial Set-up Choose Location

Place 3M™ Attest™ Auto-reader 390 on a firm level surface away from sunlight and incandescent light. To save counter space, units may be stacked two high.

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.

Select & Install Correct Power Plug The 3M™ Attest™ Auto-reader 390 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: 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™ 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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INSTRUCTIONS FOR USE – Wells, Buttons, & Display Interpretation

Please familiarize yourself with the face of the 3M™ Attest™ Auto-reader 390:

Wells 1. Incubation/Reader Wells – The 3M™ Attest™ Auto-reader 390 has ten incubation wells.

Buttons 2. Information / Up Arrow Button

INSTRUCTIONS FOR USE – 3M™ Attest™ Auto-reader 390 Configuration

Note: Ideally, the 3M™ Attest™ Auto-reader 390 should be empty (i.e., have no incubating BIs) when it is reconfigured. and buttons on the front of the 3M™ Attest™ Press the Auto-reader 390 simultaneously for 3 seconds to enter configuration mode. Once in

3. Temperature / Down Arrow Button

configuration mode, use the Up and Down buttons to set the 3M™ Attest™ Auto-reader 390 clock, audible alarm, and incubation well configuration as desired.

4. Buzzer Alarm OFF / Enter Button

acts as an “Enter” key and moves the flashing cursor to the next The button changeable setting.

Information Display

Setting the 3M™ Attest™ Auto-reader 390 Clock

5. LCD Display – Display is backlit. 6. LCD Display – Example of Error Message for well #6 7. LCD Display – Example of Remaining Incubation Time, in minutes, for well #10 8. LCD Display – Example of Negative ( - ) BI result for well #9 9. LCD Display – Example of Positive ( + ) BI result for well #8 10. LCD Display – Alarm Enabled Indicator

The 3M™ Attest™ Auto-reader 390 date and time are displayed in this format: YYYY-MM-DD HH:MM, with the time displayed using a 24 hour clock. To change the

Color-Coded Configuration Indicator 11. Color-coded incubation well configuration sticker

BI Crusher 12. BI Crusher Well

year, if necessary, push the up or down buttons to set desired year, then press advance to the month, adjust as necessary and press

to

to advance to the day. Use the

button to move to the time and set the hours and minutes.

Setting the Audible Alarm Function Move across the top row of text by pushing the button. The flashing “B” in Buzzer indicates this is a changeable setting. It is recommended this be set at “Buzzer Enabled” to audibly alert the operator to a positive BI but it may be set to “Buzzer Disabled” by using either the up or down button. Note: If Buzzer Disabled is selected, and the change accepted, the speaker icon ( ) will disappear from the LCD panel and the alarm will be disabled for all positive 3M™ Attest™ Rapid Readout Biological Indicators, error codes, and caution code alarm warnings. Note: The 3M™ Attest™ Auto-reader 390 display backlight flashes whenever an audible alarm sounds. Disabling the audible alarm does NOT disable the LCD display backlight flashing. Press

to select the desired option and advance to the bottom row of text.

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Setting the Incubation Well Configuration Incubation wells 1-5 and 6-10 can be configured to run the same or different types of 3M™ Attest™ Rapid Readout Biological Indicators. The flashing “A” in Attest indicates the setting may be changed by the user. There are three incubation well configuration options: LCD Panel Configuration Setting

Result

Attest 1291

Attest 1292

Auto-reader wells 1 - 5 configured for 1291 BIs (blue cap, 1 hour readout) and wells 6 - 10 configured for 1292 BIs (brown cap, 3 hour readout)

Attest 1291

Attest 1291

Auto-reader wells 1 –10 configured for 1291 BIs (blue cap, 1 hour readout)

Attest 1292

Attest 1292

Auto-reader wells 1 –10 configured for 1292 BIs (brown cap, 3 hour readout)

Follow this procedure for every 3M™ Attest™ Rapid Readout Biological Indicator to be read. While wearing safety glasses, CLOSE the cap of the cooled 3M™ Attest™ Rapid Readout Biological Indicator (BI) by pushing cap down.

CRUSH the glass media ampoule in the Crusher Well built into the top of the 390 Auto-reader.

Use the Up Arrow or Down Arrow buttons to move through the three options until the desired configuration setting is displayed. Press

Holding BI by the cap, TAP the bottom of the vial on a tabletop until media wets spore strip at bottom of vial. Do not tap BI on Auto-reader.

to select the desired option and advance to the Accept screen.

Note 1: If there are any incubating BIs which do not yet have a final result (+ or -) displayed, the well configuration for the occupied wells will NOT change until the final result is displayed on the LCD panel and the BI is removed from the reader. Note 2: Ensure the color-coded incubation well configuration sticker surrounding the incubation wells matches the programmed well configuration.

Setting the Optional 3M™ Attest™ Auto-reader 390 Web App Function

PLACE the crushed BI in color-coded incubation well. Observe 3M™ Attest™ Auto-reader 390 LCD panel to confirm correct placement of the BI. If the BI is correctly seated, the 3M™ Attest™ Auto-reader 390 LCD panel will display ***, **, * and then remaining minutes of incubation directly below the incubating BI.

It is recommended that the default Web Pages Enabled setting is used. If desired, however, the 3M™ Attest™ Auto-reader 390 Web App can be disabled by pressing either the up or down button. Press Accept screen.

to select the desired option and advance to the

RECORD BI result.

Note: Disabling the 3M™ Attest™ Auto-reader 390 Web App will not affect connectivity to 3rd party software.

Accept Screen Use the up or down buttons to toggle between Yes and No, press to accept changes (Yes selected) or retain current settings (No selected) and exit the configuration mode. The LCD panel will return to the standard display.

INSTRUCTIONS FOR USE - Readout Procedure Instructions for Biological Indicator (BI) Activation and Incubation WARNING: 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. CAUTION: Wear safety glasses when activating 3M™ Attest™ Rapid Readout Biological Indicators. CAUTION: 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. CAUTION: 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.

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WARNING: 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.

INSTRUCTIONS FOR USE – Additional Information BI Placement Wells must be configured and color coded to match the cap of the 3M™ Attest™ Rapid Readout Biological Indicator, e.g. the 3M™ Attest™ 1291 Rapid Readout Biological Indicator with a blue cap goes into a blue well and the 3M™ Attest™ 1292 Rapid Readout Biological Indicator with a brown cap goes into a brown well. Remaining incubation time, in minutes, will be displayed on the LCD display to indicate the 3M™ Attest™ Rapid Readout Biological Indicator is incubating in the reader well and should not be touched. The time remaining display indicates the results are not available and incubation is in progress. Do not remove 3M™ Attest™ Rapid Readout Biological Indicator until the (+) or (-) symbol on the LCD panel indicates the test is complete. Note: If 3M™ Attest™ Rapid Readout Biological Indicator is inadvertently removed before the incubation period is complete, an alarm will sound and a C2 Caution code will be displayed on the LCD panel under that well. You must return the 3M™ Attest™ Rapid Readout Biological Indicator to the reader well within 10 seconds or the results will be lost. WARNING: Do not remove or change placement of 3M™ Attest™ Rapid Readout Biological Indicator once it is placed into a well. Doing so may result in loss of results and the 3M™ Attest™ Rapid Readout Biological Indicator test may be invalid.

FEATURES OF THE 3M™ ATTEST™ AUTO-READER 390

Positive Control

Audible Alarm

Activate and incubate at least one non-processed 3M™ Attest™ Rapid Readout Biological Indicator to use as the positive control each day that a processed 3M™ Attest™ Rapid Readout Biological Indicator is incubated and read by the unit. Write a “C” (for “control”) and the date on the label. The positive control can be placed in any appropriately configured (i.e., blue or brown) incubation well. The positive control should be the same part number and have the same lot number as the processed 3M™ Attest™ Rapid Readout Biological Indicator in the unit.

An audible alarm will sound, the LCD display backlight will flash, and a (+) symbol will be displayed on the LCD panel directly under the incubating BI when a positive result is detected. An alarm will also sound if a 3M™ Attest™ Rapid Readout Biological Indicator is removed from the 3M™ Attest™ Auto-reader 390 well before a final result has been detected. Data will be lost if the 3M™ Attest™ Rapid Readout Biological Indicator is not replaced in the incubation well within 10 seconds.

The positive control biological indicator helps confirm: • correct incubation temperatures are met (heater block reading of 60ºC +/-2ºC); • viability of spores has not been altered due to improper storage temperature, humidity, or proximity to chemicals; • capability of media to promote rapid growth; and • proper functioning of 3M™ Attest™ Auto-reader 390 components.

INSTRUCTIONS FOR USE – Interpretation of Results Fluorescent Results After placing a 3M™ Attest™ Rapid Readout Biological Indicator into a corresponding color-coded well, the 3M™ Attest™ Auto-reader 390 LCD panel will display ***, **, * and then the remaining minutes of incubation directly below the incubating BI to indicate that incubation/reading is in progress. The 3M™ Attest™ Rapid Readout Biological Indicator should not be removed or touched when the display indicates remaining incubation time. A (+) will display on the LCD panel directly under the BI and an alarm will sound (if the sound feature is enabled) as soon as a positive 3M™ Attest™ Rapid Readout Biological Indicator result is detected. At the end of the specified incubation time, if a negative 3M™ Attest™ Rapid Readout Biological Indicator result is detected, a (-) will display on the LCD panel directly under the incubating BI. The final negative fluorescent result (-) for a processed 3M™ Attest™ Rapid Readout Biological Indicator after 1 hour or 3 hours of incubation, for 1291 and 1292 BIs, respectively, indicates an acceptable sterilization process. After either the + or – symbol is displayed, and the result is recorded, the 3M™ Attest™ Rapid Readout Biological Indicator can be removed from the well. The result (+ or -) is displayed on the LCD panel until the BI is removed from the Incubation well. The result clears ten seconds after the BI has been removed. Do not re-incubate BI as the result will not be valid.

Alarm On/Off The audible alarm for positive results can be turned off for a particular 3M™ Attest™ Rapid Readout Biological Indicator. This is accomplished by pressing the “Buzzer Alarm OFF” button after the alarm has sounded. This will turn off the alarm for that BI only. Any positive 3M™ Attest™ Rapid Readout Biological Indicator results subsequently detected in other wells will result in the alarm sounding. Removing the 3M™ Attest™ Rapid Readout Biological Indicator will reactivate the alarm for that well. Pressing the “Buzzer Alarm OFF” button will not silence the alarm for error or caution code alarm warnings. To disable the alarm, see configuration section.

Stackable To save counter space, 3M™ Attest™ Auto-reader 390s may be stacked two high.

Information Button When the Information button is pressed once the 3M™ Attest™ Auto-reader 390 displays two lines of text in the LCD display. The top row indicates (left to right): • 3M™ Attest™ Auto-reader 390 serial number • 3M™ Attest™ Auto-reader 390 embedded software version (V X.Y.Z) • Current date and time. The bottom row indicates (left to right): • The BI type configuration for wells 1-5. • The BI type configuration for wells 6-10. Press the information button twice and the 3M™ Attest™ Auto-reader 390 LCD panel will display two additional lines of text. The top row indicates:

The positive (unprocessed) control 3M™ Attest™ Rapid Readout Biological Indicator must provide a positive fluorescent result (+). Processed 3M™ Attest™ Rapid Readout Biological Indicator results are not valid until the positive control having the same catalog number reads fluorescent positive (+). With a processed 3M™ Attest™ Rapid Readout Biological Indicator, a positive (+) result indicates a steam sterilization process failure.

• Dynamic IP address (if unit is connected to an Ethernet jack).

Act on any positive test results immediately. Determine the cause of the positive 3M™ Attest™ Rapid Readout Biological Indicator following current facility policies and procedures. Always retest the sterilizer and do not use the sterilizer for processing loads until 3 consecutive 3M™ Attest™ Rapid Readout Biological Indicator results are negative.

Press the information button three times and the 3M™ Attest™ Auto-reader 390 LCD display will present the unique Media Access Control (MAC) Address for the device.

Optional Visual pH Color Change Result 3M™ Attest™ Rapid Readout Biological Indicators may be further incubated for a visual pH color change. This optional further incubation is not intended for routine use and may be used for special studies. Due to the high sensitivity of the fluorescent result, there is no advantage to incubating the 3M™ Attest™ Rapid Readout Biological Indicators 1291 and 1292 beyond 1 and 3 hours, respectively. In the case of a positive control BI, a yellow color change of the growth media will appear within 24 hours for 1291 BIs and within 48 hours for 1292 BIs. Any observation of a yellow color within the vial indicates a positive result. In the case of a processed BI, a media color change from purple to yellow indicates a steam sterilization process failure. A negative pH color change result, i.e., media remains purple, can be assessed at 24 hours for 1291 BIs and at 48 hours for 1292 BIs.

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INSTRUCTIONS FOR USE – Positive Control

The bottom row indicates (left to right): • Date (YYYY-MM-DD) and time that power was supplied to the 3M™ Attest™ Auto-reader 390.

Temperature Monitoring The 3M™ Attest™ Auto-reader 390 contains an internal temperature self-diagnostic program. Should the temperature fall outside the specified range (60 ºC +/-2ºC) an error code will be displayed. The heater block temperature may be checked by depressing the Temperature button once.

Easy Configuration The 3M™ Attest™ Auto-reader 390 may be configured using either the buttons located on the front of the unit or using the optional 3M™ Attest™ Auto-reader 390 Web App.

INSTRUCTIONS FOR USE – Disposal

Instrument contains a lithium battery. Dispose of instrument in accordance with federal, state, and local requirements.

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Optional 3M™ Attest™ Auto-reader 390 Web App If desired, the 3M™ Attest™ Auto-reader 390 may be connected to a PC via an Ethernet connection for additional capabilities: • Remotely view current status of BIs in the 3M™ Attest™ Auto-reader 390 via PC. For full functionality, the use of an HTML5 compliant browser with JavaScript enabled is required. • Remotely view and configure 3M™ Attest™ Auto-reader 390 settings. • View the last 100 BI records. • Print out documentation using a local or networked printer and/or save documentation as an electronic file.* Note: To access the 3M™ Attest™ Auto-reader 390 Web App within a secure network, the PC must have access to the secure network; options include connecting via a network Ethernet cable, signing in to the facility’s wireless network, or connecting via a virtual private network (VPN). * Refer to your facility’s record keeping policy and procedure.

CARE AND CLEANING CAUTION: Always unplug the 3M™ Attest™ Auto-reader 390 and allow to cool before cleaning. Do not spill liquid onto or into the instrument. Do not immerse the unit in liquid. 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. Clean the exterior surface of the 3M™ Attest™ Auto-reader 390 by wiping it with a damp cloth moistened with a mild detergent. Do not attempt to clean interior components. If additional cleaning of the wells is required, call for repair or replacement. Note: The 3M™ Attest™ Auto-reader 390 does not contain any user serviceable parts or require any routine maintenance or calibration. Any malfunctions will be indicated by an error code. Refer to the Troubleshooting Guide section for error code explanations.

TROUBLESHOOTING GUIDE

In the event of an error code, unplug the 3M™ Attest™ Auto-reader 390 and plug it back in to initiate the self-diagnostic test. If error code re-occurs, call for repair or replacement. The LCD display panel will indicate detected malfunctions by displaying a caution or error code under affected BI wells. The audible alarm, if active, sounds and the LCD display backlight flashes to alert the user to all caution (except C1) and error codes. The alarm and backlight can be silenced and extinguished, respectively, by pressing the Buzzer Alarm OFF button

. Note that disabling the audible alarm does not disable the flashing LCD display backlight. Refer to the following:

Code/ Issue

Problem

Solution

Unit Warm-up Caution

Allow a 30 minute warm-up after 3M™ Attest™ Auto-reader 390 is plugged in. (Note: 3M™ Attest™ Rapid Readout BI readings are disabled until incubator block reaches 60ºC +/- 2ºC).

C1

Incubation block not at temperature. BI Removed from Well Caution

C2

3M™ Attest™ Rapid Readout BI has been removed before incubation is complete.

C4

Ambient Light Caution Temperature Control Error

E1

E3 E7

E8

E11

E12

E14 Other

This error will occur if system is no longer able to control the temperature of the incubator block (60ºC +/- 2ºC).

Move 3M™ Attest™ Auto-reader 390 to reduced ambient light conditions. Unplug the unit and plug it back in to clear error. If error doesn’t clear, call for repair or replacement.

Memory Error

Unplug the unit and plug it back in to clear error.

3M™ Attest™ Auto-reader 390 unable to save/read data from memory.

If error doesn’t clear, call for repair or replacement.

Communications Error

Unplug the unit and plug it back in to clear error.

This error will occur if internal communications have failed.

If error doesn’t clear, call for repair or replacement.

LED Error

Unplug the unit and plug it back in to clear error.

This error occurs for a specific well if the system detects that a UV LED or Optics Detection circuit is not working.

If error doesn’t clear, call for repair or replacement. Do not use affected incubation well.

BI Inserted Incorrectly Error

Ensure BI is designed to be incubated and read in the 3M™ Attest™ Auto-reader 390.

Incubation time remaining will not display and fluorescent readings are not taken.

Ensure BI is fully inserted into incubation well.

Power Failure Error

Ensure power supply connection to Auto-reader is secure.

Power to Auto-reader was off for too long to provide valid result for affected BI(s).

Retest sterilizer with a new BI.

Ambient Light Error (occupied well)

Rely on optional visual pH color change result for BI in affected well. Move 3M™ Attest™ Auto-reader 390 to reduced ambient light conditions to avoid future occurrences.

Fluorescent result will not display. Unwanted alarm sounds when positive BI detected. Alarm Sounds

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Replace 3M™ Attest™ Rapid Readout BI in proper well within 10 seconds to prevent loss of collected data.

Other

3M™ Attest™ Rapid Readout Biological Indicator has been removed from incubation/reader well prematurely.

Other

LCD panel does not display properly.

Disable alarm; refer to 3M™ Attest™ Auto-reader 390 Configuration section for instructions. Replace 3M™ Attest™ Rapid Readout Biological Indicator in incubation/reader well within 10 seconds to prevent loss of data collected. Unplug the unit and plug it back in. If problem persists call for repair or replacement.

a Code/ Issue Other Other Other Other

Problem

Solution

Negative Control Vial

Ensure BI cap is closed, and glass ampoule is crushed. Tap BI until media flows to and wets spore strip at bottom of BI.

BI not properly activated/ media did not contact spore strip. Negative Control Vial

Check process indicator on BI label. Use a non-sterilized vial as a control.

Control vial was sterilized. Unexplained Positive BI

Do not place tape or labels on vial.

Adhesive residue on vial. Unexplained Positive BI

Place the vial so it does not come in direct contact with chemical indicators or tape.

Test vial is absorbing fluorescent residue from a chemical indicator or tape. 3M™ Attest™ Auto-reader 390 will not enter Configuration mode.

Other

Other

Pushbutton Configuration may be disabled on 3M™ Attest™ Auto-reader 390 Web App.

On 3M™ Attest™ Auto-reader 390 Web App Configuration Page, go to Pushbutton Configuration and select the Enable radio button. Save changes to begin using new setting.

3M™ Attest™ Auto-reader 390 LCD display flashes and asterisks (***) and/or E11 and/or C4 codes appear on display below unoccupied incubation wells.

Move 3M™ Attest™ Auto-reader 390 away from sunlight or sources of incandescent light.

OPTIONAL 3M™ ATTEST™ AUTO-READER 390 WEB APP Web Browser Requirements The Web Interface is designed to be viewed using an HTML5 compliant browser with JavaScript enabled (e.g., Google Chrome).

Ethernet Connection: Connection switch/router with auto-negotiation capability to identify the Auto-reader as operating at 10 Mbps and half-duplex, or able to be manually configured as 10 Mbps and half-duplex.

Connecting to the 3M™ Attest™ Auto-reader 390 Web App To use the 3M™ Attest™ Auto-reader 390 Web App, the 3M™ Attest™ 390 Auto-reader must be connected to the facility network using the supplied Ethernet cable. Consult with your facility IT personnel for assistance with network connectivity. Each 3M™ Attest™ Auto-reader 390 has a unique MAC Address which is presented on the unit’s LCD Display when the user depresses the Info button three times. The MAC Address is also provided at the bottom of the 3M™ Attest™ Auto-reader 390 Web App Configuration page. Communication occurs using the http protocol over Port 80. Users may connect to the 3M™ Attest™ Auto-reader 390 Web App using a URL based upon either the 3M™ Attest™ Auto-reader 390 serial number or the IP Address. To view the 3M™ Attest™ Auto-reader 390 Web App from a computer on a sub-net different from that to which the 3M™ Attest™ Auto-reader 390 is connected, use the IP Address URL. Note: To access the 3M™ Attest™ Auto-reader 390 Web App within a secure network, the PC must have access to the secure network; options include connecting via a network Ethernet cable, signing in to the facility’s wireless network, or connecting via a virtual private network (VPN).

A. Serial number URL 1. Connect the supplied Ethernet cable from the 3M™ Attest™ Auto-reader 390 to an Ethernet jack.

Press and release the button twice to display the 3M™ Attest™ Auto-reader 390’s dynamic IP address. Enter http://IPaddress (e.g. http://xxx.xxx.xxx.xxx) in the PC’s web browser address bar and press Enter. The 3M™ Attest™ Auto-reader 390 Web App Status page will display.

2. Static IP address Some facility IT personnel may require devices connecting to the network to use a Static IP address. If this is the case at your facility, contact the IT department to request a Static IP address. Record the static IP address provided by your facility IT department here: ___________. You may wish to label the Ethernet jack with the assigned address. Enter http://StaticIPaddress (e.g. http://xxx.xxx.xxx.xxx) in the PC’s web browser address bar and press Enter. The 3M™ Attest™ Auto-reader 390 Web App Status page will display.

About the 3M™ Attest™ Auto-reader 390 Web App Pages The 3M™ Attest™ Auto-reader 390 Web App includes four pages: a) Status page

3M™ Attest™ Auto-reader 390

Status History

ATTEST 1291 1

2

3

4

+

–

–

48

ATTEST 1292 5

6

7

8

9

+

–

–

176

10

2018-10-18 14:36

SN

200004

button once to display the 3M™ Attest™ Auto-reader 390 6-digit 2. Depress the serial number on the left side of the top row of text on the LCD display. 3. Enter http://attestxxxxxx where xxxxxx represents the unit’s serial number (e.g., http://attest001127) from Step 2 in PC web browser address bar and press Enter. 4. 3M™ Attest™ Auto-reader 390 Web App Status page will display on PC. For future ease of use, add this page to your web browser “Favorites.”

1. User-entered nickname (optional) 2. Well Configuration (1-5 and 6-10) 3. Well Number 4. BI Result/Remaining Incubation Time 5. Date and Time 6. 3M™ Attest™ Auto-reader 390 Serial Number

B. IP Address URL

The Status page provides a real-time representation of the 3M™ Attest™ Auto-reader 390 configuration and LCD panel display. The current date and time and 3M™ Attest™ Auto-reader 390 serial number are also indicated on this page. From this page, the user may navigate to:

The 3M™ Attest™ Auto-reader 390 Web App may also be accessed using either a dynamic or static IP address.

1. Dynamic IP Address A dynamic IP address is assigned when the Ethernet cable is connected from the 3M™ Attest™ Auto-reader 390 to a live Ethernet jack.

• the History page by clicking on History on the left of the screen. • the Results Detail page by clicking on the well number of an occupied well (i.e., a well that currently has an incubating BI). Clicking on an unoccupied well takes the user to the History page. 9

a

2. Enter the specific information for that BI (e.g., BI Lot #, sterilizer/load number, Technician name, etc.) in the provided editable fields. Use the Notes section to capture information not prescribed in the provided row titles; for example, you may wish to use this field to record load items.

b) Results Detail page 3M™ Attest™ Auto-reader 390 Results Detail

Status History Print Result

+

Start Time

3M™ Attest™ Auto-reader 390 Results Detail

2018-10-18 08:08:39

Status History Print

#6 1292 200004

Well# and Configuration 390 Serial Number Control?

Yes

BI Lot#

2015-02TI

Load#

n/a

Sterilizer#

n/a

390 Serial Number

Technician

sdf

Control?

No

Chemical Integrator?

n/a

BI Lot#

2015-01DS

Implant?

n/a

Load#

1

Cycle Parameters

n/a

Sterilizer#

1

Daily control BI

Technician

sdf

Chemical Integrator?

accept

Implant?

no

Cycle Parameters

270F 4min

54

Result Start Time

2018-10-18 15:26:42

Well# and Configuration

Notes

This page provides an individual record for an incubated BI. For complete documentation, the user may print a hard copy and/or save the record as an electronic file. Note 1: The top four rows (highlighted in green) are populated automatically by the 3M™ Attest™ Auto-reader 390 and cannot be changed by the user. The remaining rows are completed by the user to satisfy the documentation requirements of their facility. Note 2: The Results Detail page refreshes less frequently that the Status page. Until the BI result is available, the Results Detail page displays remaining minutes of incubation in the results field. c) History page

#2 1291 200004

3. The entered information is saved automatically to temporary web browser storage on the user’s PC every 60 seconds, or by leaving the Results Details page. 4. Print/File. Once the BI result is available, print or file the Results Detail page to create a record. The page may be physically printed and/or saved as an electronic file.

Important! Data is only stored for the last 100 incubated BIs. Embedded software in the 3M™ Attest™ Auto-reader 390 saves the data from the auto-populated (i.e., green highlighted) fields. The application relies on the temporary storage in the user’s web browser to save the data in the user-populated fields. In both cases, data is only stored for the last 100 records, i.e., the 101st incubated BI will erase the information saved for the 1st incubated BI. To retain the Results Detail information for future reference it is best practice to print the page or save to an electronic file as soon as the BI result is available.

3M™ Attest™ Auto-reader 390

Status History

ID

Well# and Configuration

1

#9 1292

2018-10-18 14:31:33 ---

2

#4 1291

2018-10-18 14:23:10 ---

3

#8 1292

2018-10-18 11:17:04 –

4

#3 1291

2018-10-18 11:16:59 –

5

#7 1292

2018-10-18 09:10:03 –

6

#2 1291

2018-10-18 09:10:02 –

7

#1 1291

2018-10-18 08:09:31 +

8

#6 1292

2018-10-18 08:08:39 +

Start Time

Using the BI History Page

Result

3M™ Attest™ Auto-reader 390

Status History

The 3M™ Attest™ Auto-reader 390 stores results for the last 100 incubated BIs on embedded software. The 3M™ Attest™ Auto-reader 390 Web App History page provides a summary of these last 100 results. d) Configuration page This page allows the configuration of the 3M™ Attest™ Auto-reader 390’s network and language settings from the 3M™ Attest™ Auto-reader 390 Web App.

Documenting BI Results using the 3M™ Attest™ Auto-reader 390 Web App

Status History

ATTEST 1291 2

3

4

+

59

–

–

ATTEST 1292 5

6

7

8

9

+

–

–

174

10

2018-10-18 15:27

SN

200004

1. Open the Results Detail page After inserting a new 3M™ Attest™ Rapid Readout BI in the 3M™ Attest™ Auto-reader 390, it is a best practice to open the 3M™ Attest™ Auto-reader 390 Web App Results Detail page for that BI by clicking on the appropriate well number from the Status page.

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Well# and Configuration

1

#9 1292

2018-10-18 14:31:33 ---

2

#4 1291

2018-10-18 14:23:10 ---

3

#8 1292

2018-10-18 11:17:04 –

4

#3 1291

2018-10-18 11:16:59 –

5

#7 1292

2018-10-18 09:10:03 –

6

#2 1291

2018-10-18 09:10:02 –

7

#1 1291

2018-10-18 08:09:31 +

8

#6 1292

2018-10-18 08:08:39 +

Start Time

Result

To view or print an individual record, click on the ID number of the desired record to navigate to the Results Detail page for that BI. Note 1: Column 1, “ID” is the assigned ID number with ID 1 representing the newest record and ID 100 representing the oldest record. For convenience, all columns are sortable; to help find a particular record, simply click once on the column heading to sort in ascending order and click a second time to reverse the order.

3M™ Attest™ Auto-reader 390

1

ID

Note 2: The History page refreshes less frequently than the Status page. Until the BI result is available, the History page displays ••• in the Results column indicating incubation is still in-process.

Certain set-up and configuration options are available on the password-protected 3M™ Attest™ Auto-reader 390 Web App Configuration page. Ideally, the 3M™ Attest™ Auto-reader 390 should be empty (i.e., have no incubating BIs) when it is reconfigured. Navigate to the Configuration page by entering either: 1) http://attestxxxxxx/protect/config.htm (where xxxxxx is the 6-digit unit serial number), or

a

Using the Configuration Page

in the web browser address bar and pressing Enter. A security screen will appear. Fill in the fields as follows: User name: manager Password: Attest and press OK.

2) http://xxx.xxx.xxx.xxx/protect/config.htm (where xxx.xxx.xxx.xxx is the IP address) Click on the desired radio buttons to change settings. Auto-reader Type

Select the configuration desired for wells 1-5/6-10 by clicking on the appropriate radio button.

Language

Selected setting indicates language in which text on 3M™ Attest™ Auto-reader 390 Web App pages will appear on the computer screen.

Pushbutton Configuration

Selecting Enable

allows the user to configure the 3M™ Attest™ Auto-reader 390 from the buttons on the unit itself.

Selecting Disable

prevents the user from being able to configure the 3M™ Attest™ Auto-reader 390 from the buttons on the unit itself.

Buzzer Configuration

Selecting Enable

enables the audible alarm. The speaker icon will appear on the 3M™ Attest™ Auto-reader 390 LCD panel.

Selecting Disable

disables the audible alarm. The speaker icon will disappear from the 3M™ Attest™ Auto-reader 390 LCD panel.

Attest Auto-reader 390 Nickname

Naming the 3M™ Attest™ Auto-reader 390 may be useful in facilities with multiple units. The assigned nickname will appear on the 3M™ Attest™ Auto-reader 390 Web App Status page.

Enable DHCP

Default: Setting is checked indicating the Web App will use the Dynamic IP address automatically assigned when the 3M™ Attest™ Auto-reader 390 is connected to the network. Remove the check if you wish to use a Static IP address assigned by your facility IT.

IP Address

Enter Static IP address assigned by IT.

Gateway

Enter Gateway.

Subnet Mask

Enter Subnet Mask.

Primary DNS

Enter Primary DNS.

Secondary DNS

Enter Secondary DNS.

MAC Address

XX:XX:XX:XX:XX:XX (Unique MAC address assigned to device. This value cannot be changed.)

Use Computer Time

Check this box if you wish to set the clock on-board the 3M™ Attest™ Auto-reader 390 using the computer’s clock.

Attest Auto-reader 390 Time

Alternatively, leave the Use Computer Time box unchecked and complete the date and time boxes to set the 3M™ Attest™ Auto-reader 390 clock.

After changing desired settings, click on Save Config button to save your changes. A new screen confirming the settings were successfully changed appears.

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a

TROUBLESHOOTING THE 3M™ ATTEST™ AUTO-READER 390 WEB APP Issue

Problem

Solution

Unable to access 3M™ Attest™ Auto-reader 390 Web App on networked computer

Web Pages have been disabled.

Enable Web Pages using push buttons on unit (see 3M™ Attest™ Auto-reader 390 Configuration section)

Unable to access 3M™ Attest™ Auto-reader 390 Web App on networked computer

3M™ Attest™ Auto-reader 390 and/or computer not connected to network. Auto-negotiation issue between the 3M™ Attest™ Auto-reader 390 and facility network switch.

Ensure 3M™ Attest™ Auto-reader 390 Ethernet cable is connected to a live jack and that connection to 3M™ Attest™ Auto-reader 390 is secure. Ensure computer is connected to network. If failure is with connection attempted using 3M™ Attest™ Auto-reader 390 serial number URL, try connecting using IP address URL. Switch port setting must be set at 10 Mbps and half-duplex. Contact facility IT or 3M if problem persists.

Data entered by user on Results Detail page disappears

User entered data is written to temporary web browser storage. Browser may have cleared data.

BI result displayed on 3M™ Attest™ Auto-reader 390 LCD panel does not appear on Results Detail page

The Results Detail page has not refreshed yet.

Use your browser to refresh the Results Detail page, or wait up to 60 seconds for the page to automatically refresh.

Results Detail page will not open from the Status page

The Results Detail page only opens from the Status page for occupied 3M™ Attest™ Auto-reader 390 wells.

Do not attempt to navigate to the Results Detail page from unoccupied wells on the Status page.

Set web browser to accept (allow or enable) cookies. As a best practice, print or save Results Detail record as soon as BI result is final.

REPAIR AND REPLACEMENT

In the U.S.A., 3M™ Attest™ Auto-reader 390s must be repaired at: 3M Health Care Service Center Suite 200, Bldg. 502 3350 Granada Avenue North Oakdale, MN 55128 1-800-228-3957 Outside of the U.S.A., contact your local 3M Subsidiary. If you have questions, call our Customer Service number: 1-800-228-3957.

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