BacT ALERT 3 D New Features Guide ver B.40 (Clinical Use) May 2011

Singapore bioMérieux Singaporete. Ltd. 11 Biopolis Way, Helios, Block 11 #10-03 Singapore 138667 tel. (65) 6513 9554 fax (65) 6478 9501 South Africa bioMérieux South Africa Pty 7 Malibongwe Drive Randburg 2125 tel. (27) 11 801 91 10 fax (27) 11 791 24 19 Spain bioMérieux España S.A. Manual Tovar, 45–47 28034 Madrid tel. (34) 91 358 11 42 fax (34) 91 358 06 29 Sweden bioMérieux Sverige AB Hantverksvägen 15 436 33 Askim tel. (46) 31 68 84 90 fax (46) 31 68 48 48

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This product and its documentation complies with the In Vitro Diagnostic Medical Device Directive 98/79/EC.

Liability Disclaimer bioMérieux, Inc. makes no express or implied warranty regarding this manual, its quality, performance, or appropriate use regarding any type of specific procedure. Furthermore, this manual may be modified by bioMérieux without notice and without implying any obligation or liability on the part of the company.

Intellectual Property bioMérieux and the blue logo, and BacT/ALERT are used, pending, and/or registered trademarks of bioMérieux SA or one of its subsidiaries. © 2011 bioMérieux, Inc. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language (human or computer) in any form, or by any means whatsoever, without the prior express written permission of bioMérieux, Inc.

Warranty bioMérieux, Inc., (“Seller”) warrants the BacT/ALERT® instrument (the “Instrument”) to the original purchaser for a period of one (1) year after date of installation against defects in material and workmanship and defects arising from failure to conform to specifications applicable on the date of installation. Seller further agrees to correct, either by repair, or, at its election, by replacement, any such defect found on examination to have occurred, under normal use and service, during such one-year period, provided Seller is promptly notified in writing upon discovery of such defect. Seller shall not be liable under this Warranty for any defect arising from abuse of the system, failure to operate and maintain the system in accordance with the documentation included with the Instrument, including repair service, alteration or modification of the system by any person other than service personnel of bioMérieux, Inc., or use of modified, changed, or previously used disposables. The warranty of Seller set forth above and the obligations and liabilities of Seller thereunder are exclusive and in lieu of all other remedies or warranties, express or implied, arising by law or otherwise, with respect to the system delivered hereunder (including without limitation any obligation of Seller with respect to merchantability, fitness for particular purpose and non-infringement). In no event shall Seller be liable for incidental or consequential damages, however arising and whether or not occasioned by Seller’s negligence. This Warranty shall not be extended or altered except by written instrument signed by Seller. All of the product elements in the Seller’s Instrument and the total Instrument are warranted to be new or equivalent to new for the full product warranty period of one year. Disposables and replacement items with a normal life expectancy of less than one (1) year, such as batteries and bulbs, are excluded from this warranty.

Table of Contents Introduction... 1 Intended Audience... 1 Version B.40 Firmware New Features... 1 New Feature Details... 1 Streamlined Method for Upgrading Firmware... 1 Keyboard Navigation on the Edit Data Relationship Screens... 1 Electronic Record of Firmware Updates and Barcode Customizations... 2 Time-to-Detection Result Included with Preliminary Results Sent to the LIS... 2 Bottle Readings Recalculated in the Event of an Algorithm Change... 2 Identifying Anonymously Loaded Bottles... 2 Status Change Due to Algorithm Recalculation... 4 Editing the Bottle Type on the Edit Bottle Detail Screen... 6

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BacT/ALERT® 3D New Features Guide Version B.40 (Clinical Use)

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BacT/ALERT® 3D New Features Guide Version B.40 (Clinical Use)

Introduction

Introduction This document provides a brief description of the new features included in the Version B.40 firmware update for the BacT/ALERT® 3D, BacT/ALERT® 3D Combination Module, and BacT/ALERT® 3D 60 instruments. For a complete description of the entire system, see the BacT/ALERT® 3D or BacT/ALERT® 3D 60 User Manual. The BacT/ALERT® 3D Version B.40 upgrade is a mandatory upgrade. It is intended to provide enhancements to the firmware. Note: Translations of this New Features Guide, as they become available, can be found in the bioMérieux Technical Library.

Intended Audience The BacT/ALERT® 3D and BacT/ALERT® 3D 60 systems, and this New Features Guide, are intended for laboratory use by trained, professional, Clinical users.

Version B.40 Firmware New Features The following features are available with the BacT/ALERT® 3D Version B.40 firmware upgrade, and are described in more detail in the next section. • Streamlined method for updating BacT/ALERT® 3D firmware. • Keyboard navigation on the Edit Data Relationships screens. • Electronic record of firmware updates and barcode customizations. • For SelectLink configurations only: Time-to-Detection result included when sending preliminary results to the Laboratory Information System (LIS). • Bottle readings recalculated in the event of an algorithm change.

New Feature Details Streamlined Method for Upgrading Firmware A new procedure is provided to initiate firmware updates from the Setup screen. See the BacT/ALERT® 3D Version B.40 Update Instructions for complete instructions on how to update your instrument with Version B.40 firmware.

Keyboard Navigation on the Edit Data Relationship Screens The BacT/ALERT® 3D system allows for keyboard navigation of screens to ensure full functionality as an alternate to using the operator panel (touch screen). The Version B.40 update now provides complete navigation using the keyboard while in the Edit Data Relationships screens. • Press the Tab key to move between major controls (for example, buttons and movement to/from the left and right side of the screen). 9300415

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• Press the F1 or F2 keys to move up and down in the scroll list to select items. • Press the Enter key to initiate the function of a selected item. See the BacT/ALERT® 3D or BacT/ALERT® 3D 60 User Manual for complete details.

Electronic Record of Firmware Updates and Barcode Customizations When the firmware is updated, the BacT/ALERT® 3D instrument maintains a record of the date and time of the update. Whenever new bottle types are added using the Bottle Processing Customization button, the BacT/ALERT® 3D instrument maintains a record of the bottle type activated, and the date and time of the activation. Update information is stored for the life of the instrument. These results are also logged in the Audit Trail; however, the Audit Trail only saves the last 100,000 logged events before deletion. To access this information in the System Update Log: 1. Press Ctrl + D simultaneously on the keyboard. The Software Test screen appears. 2. Press the 0 key. The System Update Log appears.

Time-to-Detection Result Included with Preliminary Results Sent to the LIS The BacT/ALERT® 3D Version B.30 firmware provides SelectLink customers with the option to configure the BacT/ALERT® 3D instrument to send preliminary results for a bottle to the LIS at user-defined times. Since SelectLink sent neither the time of the last bottle reading, nor a Time-to-Detection result record, some Laboratory Information Systems were not able to interpret the timing of the preliminary result. Starting with BacT/ALERT® 3D Version B.40 firmware, SelectLink now sends the time of the last bottle reading in ASTM field 10.1.13, and it will send a Time-to-Detection result record when sending results of Negative-to Date-bottles to the LIS.

Bottle Readings Recalculated in the Event of an Algorithm Change Prior to the BacT/ALERT® 3D Version B.40 firmware update, once an algorithm was assigned to analyze bottle readings, it could not be changed without the possibility of a false positive result or an operator error, which required a subculture. Starting with the BacT/ALERT® 3D B.40 firmware update, if a bottle type is changed, and this results in a change of the algorithm assigned to that bottle, the firmware applies the new algorithm and recalculates the bottle test result based on that change. The majority of algorithm changes are encountered when anonymously loaded FA or PF bottles are identified. Algorithm changes are also encountered when the bottle type is changed in the Edit Bottle Detail screen.

Identifying Anonymously Loaded Bottles When a bottle is anonymously loaded, the BacT/ALERT® 3D firmware assigns a standard algorithm to analyze the bottle readings. To avoid false negative results with anonymously loaded bottles, the standard algorithm uses the lowest threshold settings to determine a positive status. However, the algorithm parameters for some bottle types have higher threshold settings. Prior to the BacT/ALERT® 3D Version B.40 firmware update, when anonymously loaded bottles were identified, the system did not recalculate the bottle 2

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readings using their specific algorithms. When positive anonymous bottles were identified, there was an increased possibility that this could be a false positive due to the lower threshold setting used by the standard algorithm. In these cases, the customer was instructed to perform a gram stain, subculture the bottle, and then reload the bottle to continue testing. When the bottle was reloaded, the status was re-set to Negative-to-Date, and the bottle would continue testing using the bottle-type specific algorithm until the status changed to positive, or the maximum test time was reached. With the BacT/ALERT® 3D Version B.40 firmware update, if a bottle is loaded anonymously, the readings will be initially analyzed using the standard default algorithm. Once the bottle is identified, if the bottle type uses an algorithm other than the standard default algorithm, the firmware will re-analyze the bottle readings using the bottle-specific algorithm. When the BacT/ALERT® 3D Version B.40 firmware recognizes that the bottle type uses an algorithm other than the standard default algorithm, an alarm sounds and a Code 931 operator message appears to inform the operator that the test result will be recalculated (see Figure 1). Figure 1: Operator Message Code 931 - Original Algorithm

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1 - Old Algorithm 2 - New Algorithm 3 - Bottle ID

Note: Code 931 is an operator message and not an error; therefore, it is detailed in blue instead of red. The workflow steps involved with a Code 931 operator message are listed below: 1. From the Main screen, press the Unload Anonymous Negative or Negative-toDate Bottles button. The Unload Mode screen appears. 2. Open the indicated drawer and remove a bottle with the cell indicator light on. 3. Enter or scan the bottle ID into the Bottle ID field.

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Care must be taken when the bottle ID is entered using the keyboard. As soon as the second character of the bottle ID is entered, the Code 931 operator message displays. The focus is in the Bottle ID field which contains the two characters that were typed; however, the cursor is located before the characters. Move the cursor to appear after the characters already typed before entering the remaining bottle ID. IMPORTANT: If the user continues to enter the bottle ID without relocating the cursor, the remaining bottle ID is entered in front of the two characters already typed, and the bottle type changes to Generic. 4. If a Code 931 operator message appears, press the Check button to acknowledge the message. 5. When the Instrument Status Code 711 disappears, press the Tab key to move the focus to the Accession Number field and enter or scan the accession number. 6. Return the bottle to the cell with the slowly blinking cell indicator light before unloading another bottle. Do not reload the bottle if it is necessary to use the bottle label to enter information into the bioMérieux data management computer. 7. Repeat step 2 through step 6 to identify the remaining anonymous bottles.

Status Change Due to Algorithm Recalculation Because some bottle types use algorithms that have higher algorithm thresholds than the standard default algorithm, it is possible that some anonymously loaded bottles may be assigned a positive status due to the lower threshold settings of the standard default algorithm. When the bottle readings are recalculated using the bottle-specific algorithm, the status reverts to Negative-to-Date. In this situation, after the firmware has completed recalculation of the bottle readings, a Code 966 operator message appears on the screen to inform the operator that after recalculation of the bottle readings using the bottle specific algorithm, the bottle's status has changed from Positive to Negative-to-Date. The Code 966 operator message is detailed in blue to indicate that it is a message code and not an error code. The recalculated bottle status is indicated by the icon which represents a Negative-to-Date bottle status (see Figure 2).

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Figure 2: Operator Message Code 966 – Status Change to Negative-to-Date

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1 - Recalculated Bottle Status

The workflow steps involved with a Code 966 operator message are listed below: 1. From the Main screen, press the Unload Anonymous Positive Bottles button. The Unload Mode screen appears. 2. Open the indicated drawer and remove a bottle with the cell indicator light on. 3. Enter or scan the bottle ID into the Bottle ID field. Care must be taken when the bottle ID is entered using the keyboard. As soon as the second character of the bottle ID is entered, the Code 931 operator message displays. The focus is in the Bottle ID field which contains the two characters that were typed; however, the cursor is located before the characters. Move the cursor to appear after the characters already typed before entering the remaining bottle ID. IMPORTANT: If the user continues to enter the bottle ID without relocating the cursor, the remaining bottle ID is entered in front of the two characters already typed, and the bottle type changes to Generic. 4. If a Code 931 operator message appears, press the Check button to acknowledge the message. 5. When Instrument Status Code 711 disappears, a Code 966 operator message appears indicating that the algorithm recalculation changed the bottle test result to Negative-to-Date. 6. Press the Check button in the Code 966 message to acknowledge the message, and then move the focus to the Accession Number field and scan or enter the accession number. 7. Return the bottle to the cell with the slowly blinking cell indicator light before unloading another bottle. Do not reload the bottle if it is necessary to use the bottle label to enter information into the bioMérieux data management computer. 8. Repeat step 2 through step 7 to identify the remaining positive anonymous bottles.

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Note: Since the Code 966 operator message is only encountered when identifying anonymous positive bottles, some operators may choose to unload the bottle and perform a gram stain and subculture of this bottle. This action is not necessary; however, the operator is free to perform a gram stain and subculture if they choose.

Editing the Bottle Type on the Edit Bottle Detail Screen Prior to the BacT/ALERT® 3D Version B.40 firmware update, if the bottle type was changed from the Edit Bottle Detail screen, a Code 942 Operator Error appeared (Bottle Type Change Requires Different Algorithm). If the Check button was pressed, the bottle status was changed to positive with a How Determined code indicating an Algorithm Change. The cell was flagged with an Instrument Fault Code 74 (Algorithm Change). The resolution was to unload the bottle, subculture, and reload the bottle using the Load Bottle function. The original first loaded date and time was applied to this bottle. Starting with the BacT/ALERT® 3D Version B.40 firmware update, if the bottle type is changed on the Edit Bottle Detail screen and this change is saved by pressing the Check button, the firmware displays Instrument Status Code 711 to indicate that the bottle readings are being recalculated using the algorithm specific to the newly assigned bottle type. If the recalculation of the bottle readings causes a status change for that bottle, one of the following operator messages appears to inform the operator of the status change. • Code 964 - Algorithm Recalculation Changed Bottle Test Result to Negative • Code 965 - Algorithm Recalculation Changed Bottle Test Result to Positive • Code 966 - Algorithm Recalculation Changed Bottle Test Result to Negative-to-Date

Technical Support For US customers: Contact Customer Service at 800-682-2666. For customers outside the US: Contact your local bioMérieux representative.

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