VITEK 2 Instrument User Manual June 2008

Norway bioMérieux Norge AS Økernveien 145 N-0513, Oslo tel. (47) 23 37 55 50 fax (47) 23 37 55 51

Spain bioMérieux España S.A. Manual Tovar, 45–47 28034 Madrid tel. (34) 91 358 11 42 fax (34) 91 358 06 29

Philippines (The) Representation Office bioMérieux Philippines 11th Floor, Pearlbank Centre 146 Valero Street, Salcedo Village 1227 Makati City tel. (632) 817 7741 fax (632) 812 0896

Sweden bioMérieux Sverige AB Hantverksvägen 15 436 33 Askim tel. (46) 31 68 84 90 fax (46) 31 68 48 48

Poland bioMérieux Polska Sp. Z.o.o. Ul. Zeromskiego 17 01-882 Warsaw tel. (48) 22 569 85 00 fax (48) 22 569 85 54 Portugal bioMérieux Portugal, Lda. Av. 25 de Abril de 1974, nº 23-3º 2795-197 LINDA-A-VELHA tel. (351) 21 415 23 50 fax (351) 21 418 32 67 Russia o.o.o. bioMérieux Derbenevskaya ul. 20, str. 11 115 114 Moscow tel. (7) 495 221 10 79 fax (7) 495 221 10 79

Manual Name 702358-4EN1 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 Regent House Bldg, 16th Floor 183 Rajdamri Road, Lumpini, Pathumwan Bangkok 10330 tel. (66) 2 651 98 00 fax (66) 2 651 98 01 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

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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, the blue logo, bioLIAISON and VITEK are used, pending and/or registered trademarks belonging to bioMérieux SA or one of its subsidiaries. © 2008 by 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.

Patent Information Product covered by one or more of U.S. Patent Numbers D377,455; 5,670,375; 5,674,454; 5,697,409; 5,736,102; 5,762,873; 5,762,874; 5,798,084; 5,798,085; 5,853,666; 5,853,667; 5,856,193; 5,869,006; 5,881,781; 5,888,455; 5,891,396; 5,897,835; 5,925,884; 5,955,736; 5,965,090; 6,024,921; 6,086,824; 6,136,270; 6,156,565; D414,272; D437,797; 5,609,828; 5,746,980; 5,804,437; 5,869,005; 5,932,177; 5,951,952; 6,267,929; 6,309,890; 6,340,573; D397,611; D393,592; and Foreign Counterparts.

Warranty Seller, bioMérieux, Inc., warrants the VITEK® 2 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 (1) 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 Seller; 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 consequential damages, 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

Manual Name 702357-3EN1 REV nn/nnnn

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Standard Symbols

Electric shock warning

Radiation warning

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

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Manual Name 702357-3EN1 REV nn/nnnn

Standard Symbols

Separate collection for waste electrical and electronic equipment

Very toxic

Corrosive

Sodium azide

Irritant

Positive control

Negative control

Keep away from sunlight

Protect from light

This way up

Do not stack

Humidity limitation

Manual Name 702357-3EN1 REV nn/nnnn

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Standard Symbols

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)

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)

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Manual Name 702357-3EN1 REV nn/nnnn

GENERAL WARNINGS IMPORTANT:

The user is advised to read and understand all instructions in this manual to be able to derive the best performance from the VITEK® 2 instrument and the Smart Carrier Station.

IMPORTANT:

The configuration that you have purchased is adapted to the legislation and standards of the different countries it will be sent to. For this reason, it may differ from the one presented in this document. However, this will have no effect on the performance of your VITEK® 2 instrument or the Smart Carrier Station. For further information on peripherals (computer, printer, monitor, etc.) please refer to the relevant manufacturers’ instruction manuals.

IMPORTANT:

If either the VITEK® 2 instrument or the Smart Carrier Station does not respond properly to keyboard inputs after an inadvertent electrostatic discharge or electrical fast transient, turn the power off, then back on using the power switch and resume normal operations.

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General Warnings

General Warnings BIOHAZARD WARNING This instrument may be involved with hazardous organism suspensions. This user manual does not purport to address all of the safety matters associated with the instrument’s use. It is the responsibility of the user of this instrument to establish and follow appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

BIOHAZARD WARNING All organism suspensions should be considered as potentially infectious. Qualified laboratory personnel should use acceptable procedures for biohazardous material.

LASER WARNING All access doors and covers must remain closed when processing cards to avoid exposure to laser light.

AMBIENT LIGHT/DIRECT SUNLIGHT WARNING The transmittance optics are sensitive to ambient light. Ensure all access doors are closed when cards are processing in the instrument. Do not place the instrument in direct sunlight. Strong light shining onto the front of the instrument can cause the optics to read incorrectly.

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VITEK® 2 Instrument User Manual 510731-10EN1

General Warnings

WARNING This statement only applies to European countries with regard to the waste electrical and electronic equipment European directive: You can play an important role in contributing to reuse, recycling and other forms of recovery of waste electrical and electronic equipment. Sorting this type of waste significantly reduces potential negative effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment. At the end of the life cycle of this product, do not dispose of the product as unsorted municipal waste, even if it is decontaminated. It is imperative that you contact bioMérieux to assure for its appropriate disposal.

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General Warnings

Laser Caution A laser caution label appears on the VITEK® 2 and VITEK® 2 XL at the following locations: VITEK® 2

VITEK® 2 XL

• on the front access door

• on the left front access door

• on the inside panel behind the front access door

• above the center front sliding door

• behind the waste collection door

• behind the right side waste collection door

The label appears as shown here:

CAUTION Laser light when open. DO NOT STARE INTO BEAM. 530520-2

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TABLE OF CONTENTS General Warnings ...i General Warnings... ii Laser Caution... iv List of Tables ...xiii List of Figures ...xv How To Use This Manual ... 1-1 Organization... 1-2 Documentation... 1-2 Intended Use... 1-2 How to Find Topics and Procedures... 1-3 Typographic and Usage Conventions... 1-3 References... 1-3 Graphical User Interface... 1-3 Click...1-3 Commands...1-3 Names and Titles...1-4 Press...1-4 Select...1-4 Screen Text...1-4 User Input...1-4

Warnings, Cautions, and Information... 1-5 Smart Carrier Station ... 2-1 Purpose... 2-2 Unpacking Instructions... 2-2 Unpacking Procedure... 2-3 Installation Procedure... 2-4 Preparations for Operation... 2-5 Smart Carrier Station Overview... 2-6 SCS Keyboard... 2-8 SCS Base Unit... 2-9 System Physical and Electrical Requirements... 2-9 Setup Bar Codes... 2-10 SCS Configuration ... 3-1 Configuration Overview... 3-2 VITEK® 2 Instrument User Manual 510731-10EN1

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When to Configure... 3-2 Accessing Configuration Screens... 3-3 SCS Main Configuration Options... 3-3 Cassette ID... 3-3 Setting Cassette ID...3-4

Setup Technologist ID... 3-4 Setting Setup Technologist ID...3-4

Bench Name... 3-4 Setting Bench Name...3-4

SCS Workflow Configuration Options... 3-5 AST Dilution Mode... 3-5 Setting AST Dilution Mode...3-5

Erase Cassette... 3-6 Setting Cassette Erase...3-6

Begin Data Entry... 3-6 Setting Begin Data Entry...3-6

SCS Utilities... 3-7 Language... 3-7 Setting SCS Language...3-7

Audible Feedback... 3-8 Setting Audible Feedback...3-8

Host Type... 3-8 Changing Host Type...3-8

Time and Date... 3-8 Setting SCS Time and Date...3-8

SCS Firmware Update... 3-9 VITEK® 2 Instrument ... 4-1 External Instrument Components... 4-2 Controls, Access Doors and Connections... 4-3 Connections... 4-4 Turning on the VITEK® 2 Instrument... 4-4 Startup Procedure... 4-4 Instrument Hardware Components... 4-5 Smart Carrier Station (SCS)... 4-5 Cassettes... 4-6 Cassette Load and Unload Station... 4-7 Boats... 4-8 Bar Code Reader... 4-9 Button Memory Reader... 4-10 Dispenser/Pipettor Station... 4-11 Dispenser...4-11 vi

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Pipettor...4-12 Displacement Pump Operation...4-13

Filler Station... 4-13 Sealer Station... 4-14 Test Card Incubation and Reading... 4-14 Carousel... 4-15 Optics... 4-16 Transmittance Optics...4-16

Card Ejection... 4-16 Waste Collection Station... 4-17 User Interface System... 4-18 Keypad and Screen... 4-18 Configuring the VITEK® 2 Instrument ... 5-1 Configuration Options... 5-2 Configuration Overview... 5-2 Setting Configuration Options... 5-2 Cassette Names... 5-3 Instrument Name... 5-3 Schedule Instrument QC Status... 5-4 Cassette Mode... 5-5 Dilution Mode... 5-5 Bar Code Reader... 5-6 Audible Alarm Enable... 5-6 Audible Alarm Volume... 5-6 Visual Alarm Enable... 5-7 Audible Feedback Volume... 5-7 Screen Contrast... 5-7 Waste Tray Warning Level... 5-8 Using the Interface... 5-8 Defining Character Sets... 5-9 Setting Time for QC Status... 5-10 Using Option Boxes... 5-11 Setting a Range Value... 5-12 Processing VITEK® 2 Test Cards... 6-1 Instrument Status Screen... 6-3 Displaying the Status Screen... 6-3 Instrument Status Field... 6-3 Non Standard Card Reading Mode... 6-4 Card Capacity... 6-4 Cassette Name Field... 6-5 VITEK® 2 Instrument User Manual 510731-10EN1

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Dilution Mode Indicator... 6-5 Status Screen Icons... 6-5 Monitoring Pipette Tips and Saline... 6-6 VITEK® 2 Menu System... 6-7 Frequently Used Keys... 6-9 About the Smart Carrier Station (SCS)... 6-9 Advantages of Using SCS... 6-9 Cassette Edit Screen... 6-11 Understanding the Slot Indicator... 6-12 SCS Functions... 6-13 Option Boxes... 6-14 Organism ID...6-14 Gram Positive Susceptibility Card...6-14 Offline Test Result Screen...6-14 ANC Identification Card...6-15 Offline Test Result Screen...6-15 Gram...6-15 Morphology...6-15 Aerotolerance...6-15 Modifier...6-16 Selecting an Entry Using an Option Box...6-16

Bar Code Scanner... 6-16 Processing Test Cards Using the Smart Carrier Station... 6-16 Configuration Options for Smart Carrier Workflow... 6-16 Smart Carrier Workflow... 6-17 Entering Test Information With SCS... 6-17 Correct Positioning of AST Cards...6-18

Loading a Cassette... 6-19 Using the Cassette Load Station...6-19 Loading a Cassette...6-20 Monitoring Card Processing...6-20 Tracking Cassettes and Cards...6-21

Processing Test Cards in Cassette Only Mode... 6-21 Configuration Options in Cassette Only Mode... 6-21 Cassette Only Mode Workflow... 6-21 Cassette Preparation... 6-22 Printing a Cassette Worksheet...6-22 Using the Cassette Worksheet...6-22 Correct Positioning of Susceptibility Test Cards...6-24 Using the Cassette Setup Function...6-24

Loading a Cassette... 6-25 Using the Cassette Load Station...6-26 Loading a Cassette...6-26 Monitoring Test Card Processing...6-27

Entering Data for a Cassette... 6-27 viii

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Tracking Cassettes and Cards...6-27

Batch Loads (Smart Carrier or Cassette Only Mode)... 6-28 Selecting Batch Loading... 6-28 Before You Begin...6-28

Starting a Batch Load... 6-28 Unloading the Cassette and Removing Waste... 6-30 Unloading a Cassette... 6-30 Removing Ejected Test Cards... 6-31 Removing the Waste Collection Tray...6-32 Replacing the Waste Collection Tray...6-32

Maintaining the VITEK® 2 Instrument... 7-1 Maintaining Disposables... 7-3 Monitoring the Disposables... 7-3 Interpreting the Graphs...7-3 Using the Graphs...7-4 Expiration of Disposables...7-4

The Dispenser/Pipettor Accessory Kit... 7-4 Installing an Accessory Kit, Part A: Saline and Tubing... 7-4 Installing an Accessory Kit, Part B: Pipette Tips... 7-8 Cleaning the Carousel... 7-10 Removing the Carousel for Cleaning... 7-10 Carousel Cleaning Methods... 7-15 Replacing the Carousel After Cleaning... 7-15 Cleaning the Cassettes... 7-19 Replacing the Button Memory Module... 7-20 Cleaning the Boats... 7-21 Removing Boats for Cleaning... 7-21 Cleaning the Boats... 7-23 Replacing Boats after Cleaning... 7-23 Cleaning the Instrument Interior... 7-24 Shutting Down the Instrument... 7-25 Cleaning the Test Card Collection Tray... 7-25 Cleaning Optics (Normal Maintenance)... 7-26 Cleaning the Base Pan, Vacuum Seal and Vacuum Chamber... 7-28 Cleaning the Drip Pan... 7-29 Removing the Drip Pan... 7-30 Cleaning the Drip Pan... 7-30 Replacing the Drip Pan... 7-31 Turning the Instrument On... 7-31 Cleaning the SCS... 7-32

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Troubleshooting the VITEK® 2 Instrument ... 8-1 Error Handling System... 8-3 Error Alarms... 8-4 Types of Errors... 8-4 Status Screen Error Conditions... 8-4 Instrument Halted Screen... 8-5 Reviewing an Instrument Halted Screen...8-6 Resolving a Transport Halted Screen...8-6

Message Status Screen... 8-8 Reviewing a Message Status Screen...8-9

Error Status Screen... 8-10 Reviewing an Error Status Screen...8-10

Cassette Load Processing Errors... 8-10 Types of Errors... 8-10 Workflow Considerations... 8-11 Bar Code Read Failure... 8-11 Resolving Bar Code Read Errors...8-11

SCS and Bar Code Reader Conflict... 8-13 Resolving SCS and Bar Code Reader Conflicts...8-13

Inoculum Errors... 8-14 Resolving an Inoculum Error...8-15

Card Capacity Errors... 8-16 Resolving a Card Capacity Error...8-16

Disposables Errors... 8-17 How to Resolve a Disposables Error...8-17

Working Without the Bar Code Reader... 8-17 Entering Bar Codes Manually... 8-17 Disabling the Bar Code Reader...8-17 Entering Bar Codes Manually...8-18

Instrument Diagnostics... 8-18 Instrument Diagnostics Menu... 8-18 Diagnostic Tests... 8-19 Checking the Instrument Temperature...8-19 Dispenser/Pipettor Diagnostic Test...8-20 Dispenser/Pipettor Volumetric Test...8-21

Cleaning Optics (Cards Processing)... 8-23 Optical Diagnostic Test... 8-26 Boat Transport Positions... 8-26 Power Failures... 8-28 Displaying Version Information... 8-28 Using Error Message and Recovery Table... 8-29 Restarting the Instrument... 8-29 x

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Appendix A: Hardware Specifications ...A-1 VITEK® 2 Instrument... A-1 Dimensions... A-1 Mass... A-1 Environment... A-2 Electrical Characteristics... A-3 Optical Characteristics... A-3 Transmittance Optics... A-3

General Characteristics... A-4 Cassette... A-4 Dispenser... A-4 Pipettor... A-4 Vacuum (Filler)... A-4 Sealer... A-4 Incubator... A-4

Glossary ... Glossary-1 Index ... Index-1 Notes ... Notes-1

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