BacT ALERT 3 D User Manual Feb 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

Manual Name 702383-1 REV nn/nnnn

Switzerland bioMérieux Suisse s.a. 51, avenue Blanc Case postale 2150 1211 Genève 2 tel. (41) 22 906 57 60 fax (41) 22 906 57 42 Taiwan Representation Office bioMérieux China Limited Taiwan Branch RM 608, No. 6-3 Ching Cheng Street Taipei 105 tel. (886) 2 2545 2250 fax (886) 2 2545 0959 Thailand bioMérieux Thailand Ltd 3195/9 Vibulthani Tower, 4th Floor Rama IV Road, Klongton, Klongtoey Bangkok 10110 tel. (66) 2 661 56 44 fax (66) 2 661 56 45

Turkey bioMérieux Diagnostik A.S. Değirmen Sok. Nida Plaza Kat:6 34742 Kozyataği-Istanbul tel. (90) 216 444 00 83 fax (90) 216 373 16 63 United Kingdom bioMérieux UK Ltd Grafton Way, Basingstoke Hampshire RG22 6HY tel. (44) 1256 461881 fax (44) 1256 816863 USA bioMérieux, Inc. 100 Rodolphe Street Durham NC 27712 tel. (1) 919 620 2000 Vietnam Representation Office bioMérieux Vietnam Room 4A, 4th Floor Green House Building 62A Pham Ngoc Thach Street, Ward 6 District 3 Ho Chi Minh City tel. (84) 88 209 906 fax (84) 88 209 905

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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, BacT/ALERT, BacT/LINK and MB/BacT are used, pending, and/ or registered trademarks of bioMérieux in the USA and other countries. CLSI is a registered trademark of Clinical and Laboratory Standards Institute, Inc. PSC and Quickscan are registered trademarks of PSC, Inc. Zip is a registered trademark of Iomega Corporation. © 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.

STANDARD SYMBOLS The following table presents symbols that may appear in the instructions for use or on the instrument, package inserts, or packaging. CE-Marking of Conformity

Consult Instructions for Use

Use by

Manufacturer

Date of manufacture

Contains sufficient for <n> tests

Keep dry

Fragile, handle with care

Caution, consult accompanying documents

Biological risks

Electric shock warning

Radiation warning

MANUAL NAME 702382-1EN1 REV NN/NNNN

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Standard Symbols

Potential pinch-point warning

Laser

Temperature limitation

Upper limit of temperature

Lower limit of temperature

In Vitro Diagnostic Medical Device

Batch code

Authorized Representative in the European Community

Catalog number Serial Number Do not reuse

Recyclable

Separate collection for waste electrical and electronic equipment

Very toxic

Corrosive

Sodium azide

Irritant

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MANUAL NAME 702382-1EN1 REV NN/NNNN

Standard Symbols

Positive control

Negative control

Keep away from sunlight

Protect from light

This way up

Do not stack

Humidity limitation

Fuse Direct current Alternating current Both direct and alternating current Three-phase alternating current

Earth (ground) terminal

Protective conductor terminal

Frame or chassis terminal

Equipotentiality

ON (supply)

MANUAL NAME 702382-1EN1 REV NN/NNNN

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Standard Symbols

OFF (supply)

ON (only for a component of the system equipment)

OFF (only for a component of the system equipment)

Equipment protected throughout by double insulation or reinforced insulation (Equivalent to Class II of IEC 536)

Potential tip over/crush hazard

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MANUAL NAME 702382-1EN1 REV NN/NNNN

Table of Contents How To Use This Manual ... 1-1 Intended Audience...1-1 Specimen/Sample...1-1 Purpose of the BacT/ALERT® 3D System...1-1 Additional Supplies...1-2 Purpose of This Manual...1-2 Manual Organization...1-3 Chapter Organization...1-4 Finding Topics...1-4 Typographic and Usage Conventions...1-4 Name and Titles...1-4 Press...1-5 Procedural Steps...1-5 References...1-5 Select...1-5 User Input...1-5 Warnings, Cautions, and Information...1-6

System Overview... 2-1 Introduction...2-1 Hardware Configuration...2-1 Software Configuration Options...2-1 21 CFR Part 11 and HIPAA...2-2 Theory Of Operation...2-2 Principle of Detection... 2-2

Electrical Warnings...2-3 Electrical Grounding...2-5 Electrical and Electronic Recycling...2-6 Fuse Replacement...2-6 BacT/ALERT® 3D Hardware...2-6 Mycobacteria Drawers (Clinical Use)...2-6 Controller Module...2-7 Operator Panel... 2-7 Barcode Reader Aperture... 2-7 Backup Drive... 2-8 Keyboard Drawer... 2-8 Quick Reference Card... 2-8 Keyboard... 2-8 Accessing the Controller Module Keyboard... 2-8 Printer Port... 2-10 Audible Alarm Speaker... 2-10 External Speaker Port... 2-10 411205

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Power Connector... 2-10 Power Switch... 2-10 Display Switch Assembly... 2-11 CPU 1 Port... 2-11 CPU 2 Port... 2-11 Module Ports (6)... 2-11 Monitor Port... 2-11 Modem Port... 2-11 LIS Port (Diagnostic Port)... 2-11 COMM Port... 2-11

Controller Module Specifications... 2-11 Electrical Power Services Requirements... 2-11 Power Consumed in Watts... 2-11 Heat Dissipated... 2-11 Sound Emission... 2-11 Instrument Dimensions... 2-11

Controller Module Environmental Requirements... 2-12 Operating Temperature Range... 2-12 Storage Temperature Range... 2-12 Operating Humidity Range... 2-12 Storage Humidity Range... 2-12 Maximum Operating and Storage Altitude... 2-12 Pollution degree 2 in accordance with IEC 664... 2-12 Overvoltage Category II per IEC 664... 2-12

Combination Module... 2-13 Operator Panel... 2-14 Barcode Reader... 2-14 Keyboard... 2-14 UPS... 2-14 Backup Drive... 2-14 Drawer... 2-15 Rack... 2-15 Cell... 2-15 Cell Indicator Lamp/Cell Indicator Light... 2-15 Cell Flag... 2-15 Thermometer (Not Shown)... 2-15 Drawer Indicator Light - Yellow... 2-15 Drawer Indicator Light - Green... 2-16 Printer Port... 2-16 External Speaker Port... 2-16 Power Connector... 2-16 Power Switch... 2-16 Display Switch Assembly... 2-16 CPU 1 Port... 2-16 CPU 2 Port... 2-16 Module Port (3)... 2-16 Modem Port... 2-16 LIS Port... 2-16 Barcode Scanner Port... 2-16 Keyboard Port... 2-16 Monitor Port... 2-16

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COMM Port... 2-17

Combination Module Specifications...2-17 Electrical Power Services Requirements... 2-17 Power Consumed in Watts... 2-17 Heat Dissipated... 2-17 Combination Module Dimensions... 2-17 Sound Emission... 2-17

Combination Module Environmental Requirements...2-17 Operating Temperature Range... 2-17 Storage Temperature Range... 2-17 Operating Humidity Range... 2-17 Storage Humidity Range... 2-17 Maximum Operating and Storage Altitude... 2-17 Pollution degree 2 in accordance with IEC 664 (Clinical Use)... 2-18 Overvoltage Category II per IEC 664 (Clinical Use)... 2-18

Incubation Module...2-18 Drawer... 2-18 Rack... 2-18 Cell... 2-18 Cell Indicator Lamp/Cell Indicator Light... 2-18 Cell Flag... 2-19 Drawer Indicator Light - Yellow... 2-19 Drawer Indicator Light - Green... 2-19 Controller Module Port... 2-19 Power Connector... 2-20 Power Switch... 2-20

Incubation Module Specifications...2-20 Electrical Power Services Requirements... 2-20 Power Consumed in Watts... 2-20 Heat Dissipated... 2-20 Instrument Dimensions... 2-20 Sound Emission... 2-20

Incubation Module Environmental Requirements...2-20 Operating Temperature Range... 2-20 Storage Temperature Range... 2-20 Operating Humidity Range... 2-20 Storage Humidity Range... 2-20 Maximum Operating and Storage Altitude... 2-20

Instrument Installation and Setup (Clinical Use)...2-21 Instrument Installation and Setup (Industry Use)...2-21 BacT/ALERT® 3D Software...2-21 Operator Panel Screens...2-21 Common Screen Elements...2-22 Icon... 2-22 Button... 2-22 Common System Buttons... 2-23 Scroll Button... 2-23 Slidebar Switch... 2-23 Anchor Display/Scroll Buttons... 2-24

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Text Entry Field... 2-24

Basic Functions (Clinical Use)...3-1 Introduction... 3-1 Monitoring the System... 3-2 Main Screen Introduction... 3-2 Background Color... 3-2 Instrument Icon... 3-2 Bottle Count Table... 3-3

Viewing Faults... 3-4 Viewing the Cell Status Screen... 3-4 Understanding the View Cell Status Screen Display... 3-5

Text/Data Entry... 3-7 Common Text Fields and Field Limit... 3-7 Using the Barcode Scanner to Enter Data... 3-7 Manually Entering Text into a Data Entry Field (Keyboard)... 3-8 Loading Bottles... 3-8 Loading Bottles... 3-8 Changing the Maximum Test Time - Individual Bottles... 3-11 Handling Anonymous Bottles... 3-12 Unloading Bottles... 3-13 Unloading Identified Bottles... 3-13 Unloading Anonymous Bottles... 3-14 Handling Unconfirmed Positive Bottles (False Positives)... 3-16 Accessing the Setup Screen Function Buttons... 3-17 Accessing the Setup Screen... 3-17 Inactivity Timeout for all Setup Screens... 3-18

Setup Screen Function Buttons... 3-18 Viewing and Printing... 3-19 Introduction... 3-19 Viewing Bottle Data... 3-19 Viewing/Printing Reports... 3-20 Viewing/Printing Graphs... 3-20 Using the Print Screen Function... 3-20

Viewing, Printing, and Exporting Test Data... 3-20 Viewing and Printing Bottle Graphs... 3-26 Display Bottle Readings... 3-28 Sending/Requesting LIS Information... 3-32 Sending Results to the LIS... 3-32 Requesting Information from the LIS... 3-32

Basic Functions (Industry Use) ...4-1 Introduction... 4-1

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Monitoring the System...4-1 Main Screen Introduction...4-1 Background Color... 4-2 Instrument Icon... 4-2 Bottle Count Table... 4-3

Viewing Faults...4-4 Viewing the Cell Status Screen...4-4 Understanding the View Cell Status Screen Display... 4-5

Text/Data Entry...4-7 Common Text Fields and Field Limits...4-7 Using the Barcode Scanner to Enter Data...4-7 Manually Entering Text into a Data Entry Field (Keyboard)...4-8 Loading Bottles...4-8 Loading Bottles...4-8 Changing the Maximum Test Time - Individual Bottles...4-11 Handling Anonymous Bottles...4-11 Unloading Bottles...4-11 Unloading Identified Bottles...4-12 Unloading Anonymous Bottles...4-13 Handling Unconfirmed Positive Bottles (False Positives)...4-15 Accessing the Setup Screen Function Buttons...4-16 Accessing the Setup Screen...4-16 Inactivity Timeout for all Setup Screens... 4-17

Setup Screen Function Buttons...4-17 Viewing and Printing...4-19 Introduction...4-19 Viewing Bottle Data... 4-19 Viewing/Printing Reports... 4-19 Viewing/Printing Graphs... 4-19 Using the Print Screen Function... 4-19

Viewing, Printing, and Exporting Test Data...4-20 Viewing and Printing Bottle Graphs...4-25 Display Bottle Readings...4-27 Sending/Requesting LIS Information...4-31 Sending Results to the LIS...4-31 Requesting Information from the LIS...4-31

Editing Test Data (Clinical Use) ... 5-1 Viewing/Editing Bottle Data...5-1 Introduction...5-1 Selecting Bottles Using the Edit Cell Contents Button...5-1 Selecting Bottles Using the Select Bottle to Edit/Graph Button...5-2 Editing Bottle Details Using the Edit Bottle Detail Screen...5-3 411205

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Edit Bottle ID Field... 5-4 View Accession Number Field... 5-4 View Hospital ID Field... 5-4 View Patient First Name Field... 5-4 View Patient Last Name Field... 5-5 Edit Load Status Slidebar Switch... 5-5 Edit Maximum Test Time Scroll Buttons... 5-5 Edit Bottle Type Scroll Button... 5-5 View Cell Location Icon... 5-5 View First Loaded Time Icon... 5-6 View Last Unloaded Time Icon... 5-6 View Time of Last Bottle Reading Icon... 5-6 View Test Time Icon... 5-6 View Test Result Icon... 5-6 Edit Test Result Button... 5-6 Graph Bottle Readings Button... 5-7 View Algorithm/Polynomial Icon... 5-7 View How Determined/Positivity Index Icon... 5-8

Editing Data Relationships... 5-9 Introduction... 5-9 Initiating the Edit Data Relationships Function... 5-9 Editing Bottle ID to Accession Number Relationships... 5-11 Attaching Bottle IDs without an Accession Number to an Accession Number... 5-11 Moving a Bottle ID Association from one Accession Number to Another... 5-12

Editing Accession Number to Hospital ID Relationships... 5-13 Attaching Accession Numbers without a Hospital ID to a Hospital ID... 5-13 Moving an Accession Number Association from one Hospital ID to Another... 5-13

Editing Hospital ID to Patient Name Relationships... 5-14

Editing Test Data (Industry Use)...6-1 Viewing/Editing Bottle Data... 6-1 Introduction... 6-1 Selecting Bottles Using the Edit Cell Contents Button... 6-1 Selecting Bottles Using the Select Bottle to Edit/Graph Button... 6-2 Editing Bottle Details Using the Edit Bottle Detail Screen... 6-3 Edit Bottle ID Field... 6-4 View Sample ID Field... 6-4 View User Defined 1... 6-4 View User Defined 2... 6-4 View User Defined 3... 6-4 Edit Load Status Slidebar Switch... 6-5 Edit Maximum Test Time Scroll Buttons... 6-5 Edit Bottle Type Scroll Button... 6-5 View Cell Location Icon... 6-5 View First Loaded Time Icon... 6-6 View Last Unloaded Time Icon... 6-6 View Time of Last Bottle Reading Icon... 6-6 View Test Time Icon... 6-6 View Test Result Icon... 6-6 vi

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Edit Test Result Button... 6-6 Graph Bottle Readings Button... 6-7 View Algorithm/Polynomial Icon... 6-7 View How Determined/Positivity Index Icon... 6-8

Editing Data Relationships...6-9 Introduction...6-9 Initiating the Edit Data Relationships Function...6-9 Editing Bottle ID to Sample ID Relationships...6-10 Attaching Bottle IDs without a Sample ID to a Sample ID... 6-10 Moving a Bottle ID Association from one Sample ID to Another... 6-11

Editing Sample ID to User Defined 3 Relationships...6-12 Attaching Sample IDs without a User Defined 3 to a User Defined 3... 6-12 Moving a Sample ID Association from One User Defined 3 to Another... 6-12

Editing User Defined 3 to User Defined 1/User Defined 2 Relationships...6-13

Software Configuration... 7-1 Setting the Maximum Test Time...7-1 Setting the Audible Alarms...7-2 Priority of Alarms...7-3 Terminating an Instrument Alarm...7-3 Changing the System Password...7-4 Initiating Manual Backup...7-5 Configuring Report Screens...7-7 Introduction...7-7 Entering Report Labels...7-7 Configuring Report Contents...7-10 Load Report Configuration Screen (Clinical Use)... 7-12 Status Report Configuration Screen (Clinical Use)... 7-13 Unload Report Configuration Screen (Clinical Use)... 7-14 Load Report Configuration Screen (Industry Use)... 7-15 Status Report Configuration Screen (Industry Use)... 7-16 Unload Report Configuration Screen (Industry Use)... 7-17

Viewing and Printing Calibration Data...7-17 Viewing and Printing Calibration History...7-19

System Maintenance... 8-1 Hardware Maintenance...8-1 Preventative Maintenance...8-1 Safety Precautions and Procedures...8-1 General Precautions... 8-2 Spill Cleanup... 8-2 Disinfection Procedure for Spills Onto the Instrument (Clinical Use)... 8-3 Disinfection Procedure for Spills Onto the Instrument (Industry Use)... 8-3 Disinfection Procedure for Spills Within the Instrument... 8-3

Using the Keyboard in Place of the Operator Panel...8-6

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BacT/ALERT® 3D User Manual

UPS On/Off Button Location... 8-7 Controller Module... 8-7 Combination Module... 8-8

Controller/Combination Module Reboot/Shutdown (BacT/ALERT® 3D Select and SelectLink)... 8-8 Shutdown Method 1... 8-8 Shutdown Method 2... 8-8 Shutdown Method 3... 8-9 Shutdown Method 4... 8-10

Controller or Combination Module Startup... 8-10 Full System Shutdown (BacT/ALERT® 3D Signature)... 8-10 Full System Startup (BacT/ALERT® 3D Signature)... 8-10 Set Up an External Monitor... 8-11 Restore Internal Monitor Settings... 8-11 Software Maintenance... 8-12 Restarting an Incubation Module or the Combination Module Drawers... 8-12 Setting and Formatting the System Date and Time... 8-13 Enabling and Disabling Modules, Drawers, Racks, and Cells... 8-14 Relocating Bottles... 8-16

Adjusting an Incubation or Combination Module’s Temperature... 8-17 Checking an Incubation or Combination Module’s Temperature... 8-17 Setting the Optimal Temperature for an Incubation or Combination Module... 8-19 Calibrating an Incubation or Combination Module’s Temperature... 8-20

Calibrating an Instrument Cell... 8-20 Locating a Cell Which Failed Calibration... 8-20 Viewing a Cell’s Readings and/or Calibrating a Cell... 8-20

Viewing Incubation Module Information... 8-23

System Troubleshooting ...9-1 Introduction... 9-1 Fault Codes... 9-1 Instrument Fault Codes... 9-1 Instrument Status Codes... 9-14 Operator Error Codes... 9-16 Bottle Problems... 9-25 User Output Device Problems... 9-26

21 CFR Part 11 Mode ...10-1 Log In/Out of System - 21 CFR Part 11 Mode... 10-1 Logging In for the First Time... 10-1 Logging In... 10-3 Inactivity Timeout... 10-4 Login Errors... 10-5 Change Password... 10-5

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Change Password Errors...10-6 Logging Out...10-8 Configuring Users - 21 CFR Part 11 Mode...10-8 Adding a User...10-9 Deleting a User...10-9 Deleting More Than One User... 10-10

Clearing a User Password...10-10 Clearing More Than One User Password... 10-11

Audit Trail...10-11 Accessing the Audit Trail...10-13

Mycobacterial Testing (Clinical Use)... 11-1 System Description...11-1 Intended Use...11-1 Overview...11-1 BacT/ALERT® 3D Instrument...11-2 Circulation Fan... 11-2 Rocker Clamp... 11-2 Installation Procedures and Special Requirements... 11-2 Barcodes... 11-3 Load Bottles... 11-3 Unload Positives and Negatives... 11-3 Set Maximum Test Time... 11-3 Positive Detection Algorithm... 11-3 Bottle Status... 11-3

System Startup...11-4 General Information...11-4 MB Drawer Configuration... 11-4 Limitations of the Test... 11-4 Service and Maintenance... 11-4

Theory of Operation...11-5 Principle of Detection... 11-5

Safety Features...11-6 General Precautions... 11-6 Spill Cleanup... 11-6 Disinfection Procedure for Spills Within/Onto the Instrument... 11-6 Remove Drawer... 11-7

Device Comparison for Recovery of Mycobacteria...11-7

International Character Entry...A-1 International Character Entry... A-1 Clinical Use... A-2 Industry Use... A-2

Entering International Characters... A-2

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BacT/ALERT® Culture Bottles... B-1 Introduction... B-1 Flip Cap... B-1 Stopper/Seal... B-1 Bottle... B-2 Volume Designations (Clinical Use)... B-2 Volume Designations (Industry Use)... B-2 Barcode... B-2 Sensor... B-2 Limitations of the Test... B-2 Clinical Use...B-3 Industry Use...B-3

Quality Control of Growth Performance... B-3 Blood Culture Bottles (SA, SN, FA, FN, PF, FA Plus, PF Plus, and FN Plus)... B-3 Mycobacteria Culture Bottles (MB and MP)... B-4 Culture Bottles (iAST, iNST, and iLYM)... B-4

Best Practices ... C-1 Best Practices for Preventing False Positives... C-1 Preventing False Positives - User... C-1 High Amount of White Blood Cells (Clinical Use)... C-1 Blood (or Sample) Volume too High... C-1 Large Bottle Loading and Unloading Events... C-2 Temperature Changes in the Environment... C-2 Bottle Not Completely Loaded into the Cell... C-3

Preventing False Positives - Instrument... C-3 Cell Noise... C-3 High Initial Value Readings... C-4 False Positive MP Process Bottles Flagged by Delta Algorithm (Clinical Use)... C-5

Glossary... D-1

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How To Use This Manual

Intended Audience The BacT/ALERT® 3D system and this manual are intended for laboratory use by trained, professional, clinical and industry users. Most material in the manual applies to both sets of users. If any information in the manual is intended for clinical use only or industry use only, it is marked Clinical Use or Industry Use.

Specimen/Sample In this manual, you will find references to both “specimen” and “sample.” “Specimen” refers to Clinical Use, and “sample” refers to Industry Use.

Purpose of the BacT/ALERT® 3D System The BacT/ALERT® 3D Microbial Detection System is a totally automated test system capable of incubating, agitating, and continuously monitoring aerobic and anaerobic media inoculated with: • patient specimens suspected of having bacteremia, fungemia, and/or mycobacteremia (Clinical Use), or • samples to be monitored for bacterial or fungal contamination (Industry Use). CAUTION: bioMérieux shall not be liable as to any defect (including, but not limited to, incorrect results that may affect patient outcomes) arising from the following conditions: • Abuse of the instrument. • Failure to operate and maintain the instrument in accordance with the User Manual. • Operation of the instrument by a person who has not been trained in its operation by bioMérieux. • Repair, service, alteration or modification of the instrument by any person other than service personnel of bioMérieux. • Modification, change or reuse of the disposables supplied by bioMérieux for use in the instrument. • Use of disposables (bottles) other than those supplied by bioMérieux.

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BacT/ALERT® 3D User Manual

Additional Supplies

CAUTION: This BacT/ALERT® 3D User Manual is only intended for use with B.40 Software or higher. The software version B.40 (or higher) is displayed at the bottom of the instrument icon on the Main screen. CAUTION: All figures depicting operator screens are examples only. Actual screens may differ to the extent they are affected by the actual data entered by the operator, or actual data transmitted to the instrument over the DBMS or LIS interface, or actual data generated by the instrument. CAUTION: Regarding section "Entering Report Labels," the user is solely responsible for the choice of customized report label text and for validating that the intended label text appears in all associated reports. bioMérieux shall not be liable for any consequences resulting from misinterpretation of customized report labels. CAUTION: (Industry Use) The BacT/ALERT® system is marketed for use in the detection of microorganisms in blood and other normally sterile body fluids, and in the detection of microorganisms in other sample matrices and for additional specific indications for use, as specified in the package inserts, user manuals, and labeling of the specific components of the BacT/ALERT® system. Customers who use the BacT/ALERT® system in testing of sample types or for indications other than those described in the applicable package inserts and user manuals do so at their own risk. Performance characteristics for the BacT/ALERT® system for any use outside the labeling, package insert, or user manual have not been established.

Additional Supplies Contact bioMérieux or your local vendor for laboratory supplies and accessories.

Purpose of This Manual This manual focuses on the BacT/ALERT® 3D software application and how you use it in your workflow. It contains step-by-step procedures for using your BacT/ALERT® 3D system. By using these procedures, you can perform all the functions required to operate your system, including: • accessing the BacT/ALERT® 3D software • system monitoring • entering data (where applicable) • loading and unloading bottles

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How To Use This Manual

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