VIDAS and mini VIDAS Service Manual Ver 1.0 1st Edition Jan 2011

VIDAS® - mini VIDAS® Service Manual Warning

Warning Information in this document is subject to change without notice. Should a change to this manual become necessary, revision will be performed in accordance with the applicable bioMérieux Control Procedure and will take place at the Chapter level. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose without express written permission of bioMérieux S.A.

Trademarks bioMérieux, the blue logo and VIDAS are used, pending and/or registered trademarks belonging to bioMérieux S.A. or one of its subsidiaries. Any other name or trademark is the property of its respective owner. © 2011 bioMérieux S.A. Photos: bioMérieux / bioMérieux S.A. RCS Lyon 673 620 399

Revision History Version

Date

Changes

1.0

01/2011

First Edition

VIDAS and mini VIDAS Service Manual

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VIDAS® - mini VIDAS® Service Manual Revision History

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VIDAS and mini VIDAS Service Manual

0 VIDAS® - mini VIDAS® Service Manual Warning Trademarks Revision History

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1 1. How To Use This Manual Scope of the Manual 1-2 Organization of the Manual 1-3 Layout and Functions of the HTML Service Manual 1-4 The Contents tab 1-4 The Search tab 1-5 Typographic Conventions 1-8 mini VIDAS Keypad 1-8 VIDAS 1-9 Glossary and Abbreviations 1-10

2 2. General Description Introduction to the VIDAS and mini VIDAS System 2-2 The VIDAS and mini VIDAS System 2-2 mini VIDAS System Description 2-4 VIDAS System Description 2-5 mini VIDAS Operator Interface 2-7 VIDAS Operator Interface 2-7 Protocols 2-10 Test Description 2-10 Antigen Detection 10 Antibody Detection 11 Analysis Methods 2-11 Single Reagent Strip 12 Dual Reagent Strip - Qualitative Assays 13 Quantitative Assays 13 System Composition 2-15 The mini VIDAS Hardware 2-15 Sections 15 Reagent Strip Tray 15 SPR Block 16 Operating Status Light 16 Microprocessor 16 Incubators 17 Strip Preparation Tray (only concerns mini VIDAS blue) 17 Detection System 18 Central Processing Unit 19 Keypad and Screen 19 Internal Printer 21

User Manual

Rear Panel Components 21 Bar Code Readers 23 mini VIDAS (Grey and Blue): Internal Printer 23 The VIDAS Hardware 2-23 Configuration Components 24 Hardware 25 Software 25 Consumables 25 Analytical Module 25 Microprocessor 26 Reagent Strip Tray 26 Strip Preparation Tray (only concerns VIDAS blue) 27 SPR Block 28 Incubator 28 Bar Code Readers 29 Detection System 29 Central Processing Unit 29 Computer Module 29 UPS 29 Extension Potential 30 VIDAS and mini VIDAS Consumables 2-30 Assay Kit 30 Single Reagent Strip 30 Dual Reagent Strip 30 Reagent Strip Label 31 The SPR 32 General Characteristics 2-34 mini VIDAS: Characteristics 2-34 Environmental Requirements 34 Physical Features 34 Dimensions 34 Physical Space Requirements 34 Sound Level 34 Mass 35 Electrical Requirements 35 Technical Features 35 Temperature Control 36 Optics 36 Test Kit 36 VIDAS: Characteristics 2-37 Environmental Requirements 37 Physical Features 37 Dimensions 37 Space Requirements 37 Weight 37 Sound Level 38 Electrical Requirements 38 Technical Specifications 38 Temperature Control 38

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Characteristics of Optical Components 39 Assay Kit 39

3 3. Installation And Setup Preliminary Instructions 3-2 mini VIDAS: Preparations Before Unpacking 3-2 VIDAS: Preparations Before Unpacking 3-2 Packing / Unpacking 3-3 Unpacking / Packing the mini VIDAS 3-3 Unpacking 3 Before Packing 4 Packing 4 Appendix 1 8 Unpacking the mini VIDAS (old version) 3-9 Unpacking the VIDAS 3-9 VIDAS PC Software Installation 3-11 Presentation 3-11 Introduction 11 Aim of the Procedure 11 Installation Checklist 12 Equipment Required 14 Preparing Installation 3-15 Preparation & Cabling for Compaq Deskpro EN 600 Platforms 16 Preparation & Cabling for Compaq Deskpro EVO D510 Platforms 16 Preparation & Cabling for EVO D530 Platforms 17 Preparation & Cabling for DC7600 Platforms 19 Preparation & Cabling for DC7700 Platforms 20 Preparation & Cabling for DC7800 Platforms 21 Preparation & Cabling for RP5700 Platforms 22 VIDAS: Bar Code Reader Installation 3-23 Installing the VIDAS PDF Bar Code Reader USB (Ref 99746) 24 Preparing the Bar Code Reader 24 How to Connect the Bar Code Reader on VIDAS PC 24 Connecting the Bar Code Reader 24 Connect the Bar Code Reader 25 Switch on the Computer 27 Configuring the Bar Code Reader 27 Check the Keyboard Language 27 How to Use the Bar Code Reader 30 Installing the VIDAS BARCODEREAD 3800GPDF USB (ref 93628) 30 Preparing the Bar Code Reader 30 Connecting the Bar Code Reader 31 Connect the Bar Code Reader 32 Switch on the Computer 32

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Configuring the Bar Code Reader 33 Check the Keyboard Language 33 How to use the bar code reader 35 Installing the VIDAS PC 4.0.0 Software 3-36 Installing the VIDAS PC 4.0.0 Software and Windows® XPe Operating System for EN600, EV0 510, EVO 530 Platforms, from a Migration Kit 36 Installing the VIDAS PC 4.0.0 Software and Windows® XPe Operating system for DC7600 Platforms, from a Master DVD 39 Installing the VIDAS PC 4.0.0 Software and Windows® XPe Operating System for DC7700 Platforms, from a Master DVD 40 Installing the VIDAS PC 4.0.0 Software and Windows® XPe Operating System for DC7800 Platforms, from a Master DVD 41 Installing the VIDAS PC 4.0.0 Software and Windows® XPe Operating System for RP5700 Platforms 42 Installing the VIDAS PC 4.3.0 Software 3-42 Installing the VIDAS PC 4.3.0 Software for EN600, EVO510, EVO530, DC7600, DC7700 and DC7800 Platforms 42 Installing the VIDAS PC 4.3.0 Software for RP5700 Platforms 44 Installing the Turkish Language Pack for Windows® XPe (only necessary for DC7600 and DC7700 platforms) 44 Installing the Windows® XPe Operating System and the VIDAS PC 4.6.0 Software (only for China) 45 Configuration 3-48 Checking the BIOS Parameters 48 BIOS (Setup): Boot Device Settings, only for Compaq Deskpro EN 600 and EVO D510 Platforms 49 BIOS (Setup): Boot Device Settings, only for EVO D530 Platforms 50 BIOS (Setup): Boot Device Settings, only for DC7800 Platforms 50 Selecting the Correct Regional Settings, for All Platforms and Countries 53 Specific Settings to Apply when Changing to Turkish or Polish Languages 56 Selecting the Local Keyboard and the USB PDF Bar Code Reader Language for All Platforms and All Countries 58 Selecting the Correct Date, Time and Time Zone for All Platforms and All Countries 58

User Manual

Creating New Users for All Platforms and All Countries 58 Selecting a Default Printer 60 Selecting a Default Printer for the EN600, EVO510 and EVO530 Platforms 60 Default Printer for the DC7600, DC7700, DC78000 and RP5700 Platforms 62 Using a Validated Printer Different from the Initial One (all platforms) 63 Programming the Automatic Data Backup (all platforms and all countries) 63 Equipment Required 63 Programming the Data Backup on CDs, DVDs or on the bioMérieux USB Key 63 Performing the Data Backup 65 Creating the Data Backup Task (only if necessary) 65 Checking the VIDAS PC UPS Management for All Platforms Except RP5700 68 Enabling the Network (only for DC7600 platforms) 73 Installation and Configuration of the USB Key (only for DC7800 and RP5700 platforms and for all countries) 73 Activating and Setting BCI RS232 or BCI NET Software Programs (only when requested) 78 BCI RS232 78 Displaying BCI RS232 only in French 79 BCI NET 79 Stopping LIS Requests with a Demography Change 80 Checking the System 3-83 Checking the Data Backup Functionality for All Platforms and All Countries 83 Checking the Data Restore Functionality for all Platforms with a USB Thumb Drive and All Countries for All Platforms and All Countries 84 Checking the Bar Code Reader Functionality Bar Code Reader 3800PDF for All Platforms and All Countries 85 Checking the Bar Code Reader Functionality Bar Code Reader 3800G-PDF 86 Full System Backup 3-86 Creating a Full System Backup Using the "HD Backup/Restore Tool" (Ref. 93550) 87 Restoring a Full System Backup Using the RP5700 DVD Master for All Countries 88 Creating a Full System Backup Using the RP5700 DVD Master for All Countries 90 Restoring a Full System Backup Medium

User Manual

Created Using the "HD Backup/Restore Tool" (Ref. 93550) 94 APPENDIX A: DVD Boot Problem on EVO D530 Platforms 3-95 Introduction 95 Procedure 95 APPENDIX B: Procedure for Formatting a CDRW / DVD+RW Using the InCD Software 3-96 APPENDIX C: Non Standard Printer Validation Sheet 3-99 VIDAS System Installation 3-102 Required Tools 3-102 Installation Instructions 3-102 Preliminary Recommendations: 102 Preliminary Operations: 102 Analytical Module Checks: 103 Optical Check: 103 Pipetting Check: 104 VIDAS PC - New Protocols Activation 3-107 What To Do? 3-108 To Modify 3-108 VIDAS Switching On and Initialization 3-111 Run an Optics Check as Follows: 3-112 Run a QCV Assay 3-114 VIDAS: Printer Installation 3-115 Installing the HP DeskJet 1100d Printer for VIDAS PC on Compaq EN600 & D510 Platforms 3-115 Procedure 115 Installing the HP Laser Jet 1320n Printer 3-124 Changing Computer IP Address 125 Installing the Printer 128 Installing the HP LaserJet 2015dn Printer 3-150 Configure the Computer IP Address 150 Reset and Configure the Printer 153 Configure the Computer IP Address 158 Printer Installation 161 Specific installation for VIDASPC Platforms 174 Set the Printer by Default for All Accounts 176 Installing the Lexmark E352dn Printer 3-178 Configure the Computer IP Address 179 Configure the Printer IP Addresses 182 Install the Printer 183 USB Printer Installation Procedure 194 Installing the Lexmark E360dn Printer 3-199 Configure the Computer IP Address 200 Configure the Printer IP Addresses 204 Install the Printer as Default in LAN Mode 205 USB Printer Installation Procedure 216 PCL5 Compatibility Modification 222 VIDAS: Windows XPe Platforms VU04 - Verification

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of Non-Standard Printers 3-226 Purpose 3-226 Scope 3-226 List of Standard Supported Printers - Reminder 3-226 Procedure 3-226 Getting Up-To-Date Printer Drivers 226 Install the Printer 227 Perform Printing Tests with VIDAS PC Software 227 General Printing Test (portrait orientation in one page) 227 Portrait / Landscape and Pagination Printing Test 227 Graphics Printing Test 227 Compare Reports with bioMérieux Validated Printing Samples (Appendices 1, 2, 3) 227 Fill Verification Summary Report 228 Appendix 1 3-228 Appendix 2 3-229 Appendix 3 3-230 Appendix 4 3-232 mini VIDAS System Installation 3-233 Required Tools 3-233 Installation Instructions 3-233 Preliminary Operations 3-233 Power Up 3-233 Language Selection 234 Keyboard Test 234 Printer Test 234 Installation of the External Barcode Wand 235 Air Reading Test 235 QCV Test 235 Language Selection 235 APPENDIX A: mini VIDAS Installation Record Sheet 3-237 mini VIDAS Software Installation 3-238 mini VIDAS Switching On and Initialization 3-239 mini VIDAS: Bar Code Reader Installation 3-243 mini VIDAS: Installing the MVIDAS PDF BARCODEREADER 3800G, P/N 93629 3-243 Preparing the Bar Code Reader 243 Connect the Bar Code Reader on the mini VIDAS 243 Before Installation 243 Connecting the Bar Code Reader 244 Configuring the Bar Code Reader 244 mini VIDAS: Installing the mini VIDAS PDF Bar Code Reader, ref 99747 3-245 Preparing the bar code reader 245

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How to Connect the Bar Code Reader on mini VIDAS 245 Before Installation 245 Connecting the Bar Code Reader 245 Configuring the Bar Code Reader 246 mini VIDAS: External Printer 3-247 Equipment Required 247 Installing an External Printer 247 mini VIDAS: Installing Paper in the mini VIDAS Internal Printer 3-248 Interfacing the mini VIDAS with a Laboratory Information System 3-249 Test Pattern 249 Firmware Updates 3-254 VIDAS Firmware 2.41 3-254 Scope 254 Compatibility 254 Purpose 254 New Functionality 254 Order 255 New Scanner Board Firmware 3-255 Information 255 Reason 255 Compatibility 256 Implementation 256 Software Updates 3-257 VIDAS and mini VIDAS - VU05Software Update Global Launch 3-257 Principles of the VU05 Release 257 Stakes of the VU05 Release 257 Purpose and Improvements of the VU05 Release 258 For mini VIDAS 258 For VIDAS PC 258 Known Anomalies and Their Workaround for VU05 260 VIDAS PC 260 mini VIDAS 260 Implementation of this Software Release 260 Delays 261 Field Implementation, Kit Contents, Software Update for mini VIDAS 261 Field Implementation 261 mini VIDAS Software Update to Version R5.3.0 263 mini VIDAS Kit Contents 264 Contents of all mini VIDAS Kits (all items highlighted in grey are included) 265 Software Update and Kit Contents for VIDAS PC 265

User Manual

Update VIDAS PC Software to V4.3.0 265 Field Implementation 266 VIDAS Kit Contents: 266 Contents of All VIDAS PC Kits (all items highlighted in grey are included): 267 Complaints Handling by the CCMC 267 Frequently Asked Questions (FAQ) 268 Appendix 1 - VU05 Update Troubleshooting Guide 270 Information 270 mini VIDAS 270 mini VIDAS with Software Version Different than R5.2.0 270 Solution 271 mini VIDAS with Strange Characters in the Calibration Menu 272 Solution 273 Error Message During MLE Card Reading 273 Solution 274 Error 2120, 2124, Unexplained, or Menu Not Available After Update 274 Solution 274 Incorrect Date on Display and On Reports Printout (Turkish only) 275 Solution 275 VIDAS PC 275 Error Message During MLE Card Reading 275 Solution 275 Error Messages During VIDAS PC Update 275 VIDAS PC with the Incorrect User Logged 276 Solution 276 VIDAS PC with Incorrect Software Version 276 Solution 277 VIDAS PC with Insufficient Disk Space 277 Solution 277 Update Failure with a Non-Blocking Error Message 278 Solution 278 Update Failure with a Blocking Error Message 279 Solution 279 Change to Polish or Turkish Language, in Case of Changing to Cp1252 Codepage, After the Update 279 Solution 280 No Update Report Prints Out 280 Solution 280 The Interface of BCI NT (RS232) Previously in French, Turns to English 280 Solution 280

User Manual

Particular Cases After VIDAS PC Update 280 VIDAS PC Application Displays an Error When Starting a Run 280 Solution 283 The VIDAS PC Application Does Not Transform Correctly the Letter 'i' in Uppercase (Turkish only) 284 Solution 285 Incorrect Labels When Selecting Industry Mode (Turkish only) 286 Solution 287 VIDAS CC or Text 293 Solution 293 VIDAS Software Update V4.0.0 to 4.3.0 3-295 Before You Start 295 Duration of the Update 296 Procedure 296 Once the Update is Complete 297 Troubleshooting 298 mini VIDAS Software Update V5.2.0 to 5.3.0 3298 Preliminary Conditions 298 Check the Current Version of the mini VIDAS Software 300 Prepare the mini VIDAS for the Update 302 Update the Software 303 Powering On and Initialization: 305 Read Assay Update Card Bar Codes 306 To Update an Assay 306 To Read a Bar Code 306 Print the Version Number of the Updated Software 307 Confirmation Mail 309 Troubleshooting 311 Data Backup 3-313 VIDAS: Data Backup on USB Thumb Drive 3313 Required Hardware / Software 313 Warnings and Precautions 313 Procedure 314 To Secure Data 314 To Copy the Necessary Files Attached to the USB Thumb Drive 314 To Remove Useless InCD Software and Install Necessary Fix 314 To Install the USB Thumb Drive 314 To Setup the Environment for the USB Thumb Drive 319 To Check the Data Backup Functionality 319 Starting from VIDAS PC DC7800 with Data

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Backup in USB Key 3-320 Information 320 The USB Key 320 Purpose 320 Product References 321 Warnings and Precautions 321 Installation Procedure 321 Backup and Restore 322 Archiving Feature 322 Instructions 322 Step I - Media Insertion 322 Step II - Start the Burn Backup 322 Step III (optional) - Compare the Contents of the CD Drive with the USB Key 322 Step IV - Troubleshooting and Solutions 323 Step V (optional) - Store the Burned Backup 323 Messages 323 VIDAS: Recovering or Transferring Data from a CD/DVD Media into a VIDAS PC with a USB Thumb Drive 3-324 Scope 324 Procedure to Restore Data from a CD/DVD Media onto a VIDAS Computer Equipped with a USB Thumb Drive 324 Graphical Guide to Burn Backup 3-326

4 4. System Composition Parts of the System 4-2 Temperature Control System 4-3 mini VIDAS 4 VIDAS 4 Reagent Handling System 4-4 Optics 4-6 Auto Calibration 4-9 VIDAS Scanner Board (VSB) 4-11 Incubator Board 4-12 Bay Interface Board 4-13 Motors and Sensors 4-14 mini VIDAS: VIDAS Internal Computer 4-14 mini VIDAS (Grey): Power Supply 4-15 VIDAS (Grey): Power Supply 4-15 mini VIDAS and VIDAS (Blue): Power Supply 416 mini VIDAS (Grey and Blue): Keypad Screen 418 Evolutions 4-19 mini VIDAS: Hardware changes / Internal Printer 4-19 mini VIDAS Hardware Modifications 19

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mini VIDAS Internal Printer 4-19 Hardware 20 Cable Connections 20 DIP Switch Settings 21 VIC PC Board Configuration 21 Operating FUJITSU Printer 21 mini VIDAS Grey: Internal Printer Update (Seiko - Fujitsu) 21 Boards & Schematics 4-23 mini VIDAS Block Diagram 4-23 VIDAS Block Diagram 4-24 mini VIDAS: VIDAS Internal Computer (VIC) 424 Current VIC Board 24 Purpose 24 Highlights 25 Improvements 25 Jumper Settings 26 Board Connections 27 Test Points 27 Miscellaneous 28 VIC Board (526700) 29 LEDs 30 Fuse (see marking in Figure "VIC, P/N 526700-2 Shown") 30 Standard Jumper Settings 30 Test Points 31 VIDAS and mini VIDAS: Scanner Board 4-31 VIDAS and mini VIDAS current Scanner Board (6200595) 31 LEDs 31 Power Supply: 31 Incubator Serial Communication: 31 RS232 Serial Internal Communication: 31 Scanner Cable: 32 Fuse 32 Standard Switch and Jumper Settings 32 Test Points only Used by a Field Service Engineer (FSE) 32 Scanner Board 527722 34 mini VIDAS Settings 34 LEDs 34 Fuse 34 Switch Settings 34 Standard Jumper Settings 34 Jumper Definitions 35 Test Points 35 Adjustments 35 VIDAS Settings 35 LEDs 35 Fuse 35 Switch Settings 35

User Manual

Standard Jumper Settings 35 Multiple VIDAS Configuration 36 Jumper Definitions 36 Test Points 36 Adjustments 36 VIDAS and mini VIDAS: Incubator Board 4-37 # Incubator Board Table Reminder (please refer to Figure "Incubator board P/N 6200594"): 37 LEDs 37 Sensors: 37 Power Supply: 37 RS232 Internal Serial Communication: 37 Heater regulation: 37 Fuses: 37 Standard Switch Settings: 37 Test Points 38 Incubator Board 527720 39 mini VIDAS Settings 40 Address and Reset Jumper Settings 40 Switch Settings 40 Test Points 40 Fuses 40 LEDs 40 VIDAS Settings 40 Address and Reset Jumper Settings 40 Switch Settings 41 Test Points 41 Fuses 41 LEDs 41 Incubator Board 6200594 (see Figure "Incubator board P/N 6200594") 41 VIDAS: Incubator Board (527700) 42 Standard Jumper Settings 42 Test Points 42 LEDs 43 Bay Interface Board 4-43 Switch Settings 43 Jumper Settings 43 mini VIDAS: Fujitsu Thermal Printer 4-44 Switch Settings 45 mini VIDAS: Keypad 4-45 mini VIDAS Wiring Diagram 4-47 mini VIDAS: Power Supply 4-48 Power Supply Assy 48 Fuse 48 mini VIDAS: VIDAS 12 Power Supply Board 48 Test Points 49 Fuses 49 Standard Jumper Settings 50 V12 Power Supply Board Schematic 50 VIDAS: Power Supply 4-51 VIDAS: Vidas Power Supply Block Diagram 51 Test Points for Power Supply 527152-x 51

User Manual

VIDAS: Power Supply 527166 52 PS1 Power Supply 52 VIDAS: Wiring Diagram - Power Supply 527166 53 VIDAS: Power Supply 527152 54 PS1 Power Supply 54 VIDAS: Wiring Diagram - Power Supply 527152 55 VIDAS: Vidas Power Supply Board 56 Test Points for Power Supply Board 527724-x 56 Fuses 56 Standard Jumper Settings 57 VIDAS: VDE Power Supply 57

5 5. Maintenance Decontamination and Cleaning 5-2 Routine Decontamination 5-2 Scanner Head Decontamination 5-3 Tool Decontamination 5-3 Decontamination of the VIDAS and mini VIDAS blue Module 5-3 Cleaning the SPR Block (weekly) 4 Cleaning the Strip Preparation Tray (monthly) 7 Cleaning the Reagent Strip Trays (monthly) 8 Cleaning the Plastic Trays (monthly or in the event of accidental spills) 10 Reassembling the Strip Preparation Tray and Powering On the Analytical Module 10 Reassembling the Strip Preparation Tray 10 Powering On the Analytical Module 11 Cleaning the mini VIDAS Computer Screen and Keypad (as required) 11 Cleaning the Bar Code Reader (as required) 11 Decontamination of the VIDAS and mini VIDAS grey Modules 5-11 Cleaning the SPR Block (weekly) 12 Cleaning the Reagent Strip Trays (monthly) 14 Cleaning the Plastic Tray (monthly or in the event of accidental spills) 16 Replacing the Front Panel and Powering On the Analytical Module 17 Replacing the Front Panel 17 Powering On the Analytical Module 17 Cleaning the mini VIDAS Computer Screen and Keypad (as required) 17 Cleaning the Bar Code Reader (as required) 17 Terminal Setup 5-18 Diagnostics 5-19

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VIDAS / mini VIDAS: Diagnostic Commands for VSH and VSB 5-19 Diagnostics Tests 5-20 Scanner Test 20 Section Diagnostics 5-20 Tray Test 21 Pump Test 21 Tower Test 22 Tower Preventive Maintenance 23 Section Completion 24 Internal Installations 5-25 Equipment Required 5-25 Outer Covers 5-25 mini VIDAS Right Trim Mounting 27 VIDAS (Grey and Blue) - Instrument Levelling 529 Incubator Board 5-29 To remove an Incubator Board 31 Bay Interface Board 5-32 Scanner Board 5-33 mini VIDAS: Scanner Board 33 VIDAS: Scanner Board 33 Scanner Board 6200595 (see Figure "6200595") 35 Power Supply 5-36 mini VIDAS: Power Supply Adjustment 36 Power Supply for mini VIDAS Blue (VD6003-1) 37 VIDAS: Power Supply 38 Power Supply (P/N 527166-X) 38 Power Supply for VIDAS Blue VD6002-1 39 VIDAS and mini VIDAS: Power Supply / Incubator Board Have Changed since the Beginning of Year 2003 5-40 mini VIDAS: VIDAS Internal Computer (VIC) Board 5-41 mini VIDAS (Grey and Blue): Keypad / Display / Speaker 5-43 mini VIDAS (Grey): Keypad / Display / Speaker 43 Installing OPTREX and AND Displays 43 OPTREX Installation 44 AND Installation 44 mini VIDAS Blue - Keyboard Holder Mounting 46 mini VIDAS Blue - New Screen 47 mini VIDAS: Printer / Printer Board 5-48 To Remove the Thermal Printer 48 To Remove the Thermal Printer Board 49 mini VIDAS Blue - Printer Assembly 49

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Power Supply Assembly 5-50 mini VIDAS Grey Power Supply 50 To Remove the Power Supply Assembly 50 mini VIDAS Blue Power Supply 51 Fan Replacement 54 VIDAS Grey Power Supply 55 VIDAS Blue - Power Supply Mounting 56 VIDAS and mini VIDAS Grey PS1 57 mini VIDAS Grey Power Supply Board 57 VIDAS Grey Power Supply Board 57 mini VIDAS and VIDAS Grey Fan 58 SPR Door Slide Block 5-58 New Door Plunger Ball Nut 58 Door New Safety Latch 59 New Strip Preparation Tray 5-60 Assembly 5-61 Pump Motor 5-61 Pump Assembly 5-62 VIDAS and mini VIDAS Blue and ARKRAY New Ballast 64 Spare Part Number Involved: 64 Scope 64 Assembly Procedure for Pump Ballast for VIDAS Blue, mini VIDAS blue and mini VIDAS ArkRay 65 VIDAS and mini VIDAS (Blue and Grey) Spring Retainer Plate Upgrade 67 Scope 67 Upgrading 67 Spare Part Number 67 Reworking Procedure (Optional) 67 Tower Screw Pulley Spacer (see Figure "Attachment 8") 71 Tray 5-72 Tray Motor Assembly 75 Tray Motor Assembly Spring 77 Cocked Tray 78 Vidas / mini VIDAS Inter-Tray RFV Adjustment 79 Door / SPR Block 5-79 New SPR Block 81 Scanner / Carriage VSH 5-83 Scanner Head Assembly VD0128 or VD0131 (see Figure "Attachment 17" and Figure "Attachment 18") 83 mini VIDAS: Scanner / Carriage Assembly 83 VIDAS: Scanner / Carriage Assembly 90 Flash Trigger Board Assy Replacement 92 Reference 92 Required Tools 93

User Manual

VIDAS and mini VIDAS - Replacing the Scanner Cable Assembly 96 mini VIDAS - Scanner Cable Replacement Over 2 Years Age 96 VIDAS - Scanner Cable Replacement Over 2 Years Age 96 Procedure for Replacing the Scanner Cable Assembly on VIDAS and mini VIDAS Instruments 96 Alignment and Calibration 5-104 Alignment 5-104 VIDAS and mini VIDAS: Equipment Required 104 mini VIDAS: Section Setup 104 VIDAS: Section Setup 105 Door Sensor on Blue and Grey Systems 106 Pump Sensor on Blue and Grey systems 108 Tray Sensor on Blue and Grey Systems 109 Tower Sensor on Blue and Grey Systems 111 Section Completion on Blue and Grey Systems 112 VIDAS Scanner Head (VSH) 5-113 Equipment Required 113 mini VIDAS: Setup 113 VIDAS: Setup 114 Home Flag 114 Solid Standard Bracket 115 Tray Edge Sensor 115 Bar Code Reader 117 Optics Calibration 5-120 VIDAS Scanner Head (VSH) 120 Equipment Required 120 Optics Calibration Checks 120 mini VIDAS: To Verify mini VIDAS Optics Calibration 121 VIDAS: To Verify VIDAS Optics Calibration 121 Optics Calibration Procedure 121 mini VIDAS Setup 121 VIDAS Setup 122 Rough Zero Adjustment 122 Gain Adjustment 123 Final Zero Adjustment 124 Extended Range Check 124 Auto Calibration Value Storage 125 mini VIDAS: Final Calibration Check 125 VIDAS: Final Calibration Check 125 Preventative Maintenance 5-127 Appendix B: mini VIDAS / VIDAS Blue New Parts Preventive Maintenance Corporate Impacts 5-

User Manual

127 VIDAS & mini VIDAS Preventive Maintenance Procedure 5-127 Introduction 127 Purpose 127 Scope 128 Note 128 Reference Documents 128 Materials Required 128 Required Parts / Tools 128 Required KITs and PM Replacement Intervals: 129 VIDAS / mini VIDAS - New Preventative Maintenance Kits 129 Information 129 Highlights 129 Kit Part Number, Designation, Contents and Use 129 Preliminary Recommendations 131 Preventive Maintenance Steps 132 Decontamination 132 General System Overview 132 Scanner Cable Replacement 133 Mechanical Alignments: Checks and Settings 134 Pipetting System Check 135 Optics Cleaning 136 Bar Code Reader Check 136 Optics System Check and Setting 136 Optics Calibration 137 Optics Calibration Steps Reminder 137 System Reboot 138 System Validation 138 Computer 139 Peripherals 139 Electrical Controls 139 Power Supply Assembly 140 Appendix A - Life Data Sheet 141 Appendix B- mini VIDAS Preventive Maintenance Data Sheet 143 Appendix C - VIDAS Preventive Maintenance Corporate Data Sheet 143 VIDAS Grey: Replacing Power Supply Fuse Holder 5-144 Scope 144 Explanation 144 Solution 145 Specific Cases 145 Concerned Instruments 146 Part Number to Be Ordered and Tools to Be

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Used 146 Procedure 147

6 6. Troubleshooting General Troubleshooting 6-2 mini VIDAS: Front Panel Symptoms 6-2 VIDAS: Front Panel Symptoms 6-5 mini VIDAS: Fuse Panel Removal 6-5 VIDAS: Fuse Panel Removal 6-6 mini VIDAS: Error Message Alert System 6-7 VIDAS: Error Message Alert System 6-9 Instrument errors 9 mini VIDAS: Error Message Screens 6-10 mini VIDAS: Start Errors 6-11 mini VIDAS: System Errors 6-12 VIDAS: System Errors 6-13 Scanner Codes / Errors 6-14 Section Codes / Errors / Information 6-30 mini VIDAS: Section Codes 6-30 VIDAS: Section Codes 6-30 mini VIDAS: Incubator Status Codes (Errors) 631 VIDAS: Incubator Status Codes (Errors) 6-35 mini VIDAS / Vidas: System Incubator State Codes (Information) 6-38 mini VIDAS: VIC Software Codes/Errors 6-40 User Error Messages and Their Translation String Number 6-46 Fastcodes Menu 6-50 mini VIDAS: Troubleshooting Protocols 6-50 VIDAS: Troubleshooting Protocols 6-50 mini VIDAS: Test Menu 6-51 mini VIDAS: Service Menus 6-52 mini VIDAS Menu Fast Codes 6-54 Software Troubleshooting 6-56 mini VIDAS: Software Slowness Problem 6-56 VIDAS: Patch Daylight Saving Time (all VIDAS PC) 6-56 Impact of the Anomaly only when the VIDAS PC is Connected to the LIS 59 Device Troubleshooting 6-61 New SPR block 6-61 mini VIDAS (Blue) - Keys Cracked on mini VIDAS Blue Keypad 6-62 Problem 62 Solution 64 VIDAS and mini VIDAS: VIDAS Reagent Unstuck Dot (label at the top of the SPR) 6-64 Section Misaligned 65

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Worn Holder of the Section Door / Worn Holder of the Dust Cover 65 Bad Adjustment of Pump Block 66 Horizontality of the Pump Assy 66 Height of Tower 66 Pump Ballast 67 VIDAS: Power Supply Grounding 6-68 Electronics Troubleshooting 6-73 VIDAS and mini VIDAS: Error 59 and ESD (Electro Static Discharge), Problems on Incubator Board 6-73 VIDAS / mini VIDAS: Scanner Board Information: Digipot Break Detection 6-73 Review: Failure after Power-Up Sequence or Self-Calibration 74 Printers and Printing Troubleshooting 6-75 VIDAS: Troubleshooting for HP Laser Jet 1320N 6-75 VIDAS: Troubleshooting for HP Deskjet 1100d 675 VIDAS: Warning on Page Number Print-Out Identification for VIDAS PC (V 4.0.0) only 6-77 VIDAS: Printer HP 6122 on EN600 / EVO 510 with Windows Xpe 6-77 Anomaly Description 77 Anomaly Explanation 77 Solution 77 Procedure 78 Barcode Reader Troubleshooting 6-90 mini VIDAS: PDF Bar Code Reader - Alarm ***Exception 3*** Task # 21 6-90 Diagnostic Port Use Description 90 "Barcode wand" Not Selected - Consequence 90 Solution 90 VIDAS: Windows XPe Platforms V4.0.0 - Bar Code Reading Anomaly During PTC Update 691 Scope 91 Problem 91 Reason 92 Solution 92 Configuration of the PDF Bar Code Reader 92 mini VIDAS (Grey) - Blank Screen when Connecting a New PDF Bar Code Reader 6-93 Anomaly Explanation 93 Restoring the Display - Solving the Anomaly 93 mini VIDAS Grey + PDF Bar Code Reader Blank Display Bypass Procedure 93 Cable Reference 94

User Manual

Cable Replacement 94 Network Communication Troubleshooting 6-96 VIDAS: BCI RS232 Problem when Opening the BCI RS232 Application 6-96 Close Applications 96 Stop "Bio-Com Server" Service 96 Delete Configuration Files 97 Delete Temporary Log File 97 Restart "Bio-Com Server" Service 98 Open BCI RS232 Software 98 Configure the BCI Link(s) 99 Restart the Link Operation in BCI RS232 Software 100 Check the Communication VIDAS PC - BCI RS232: 100 Reboot the VIDAS PC Computer 101 QCV Troubleshooting 6-102 VIDAS and mini VIDAS - Troubleshooting Guideline for QCV Results Out of Range 6-102 Introduction 102 Scope 102 Reminder of QCV (Quality Control VIDAS) 102 The QCV: How Does It Work? 103 The QCV: When? 103 The QCV: Why? 103 The QCV: Performances 103 "QCV Specificity": 103 "QCV Reproducibility": 103 Flowchart 104 Appendices to the Flowchart 104 Appendix 1 104 Appendix 2 105 Appendix 3 105 Appendix 4 106 Appendix 5 107 Appendix 6 108 Appendix 7 110

7 7. Quality Control / Specific Tools / Metrology VIDAS and mini VIDAS - Leak Test Introduction Aim of the Test Preliminary Instructions Principle 2 Warnings and Precautions 3 Storage 3 Index of Symbols 4 Procedure for Use

User Manual

7-2 7-2 7-2 7-2

7-4

First Time Use (VIDAS PTC Protocol Data Entry) 4 Performing the Assay 5 Results 5 Interpretation 6 Solutions 6 Limitations of the Method 6 VIDAS and mini VIDAS - Quality Control VIDAS (QCV) 7-7 mini VIDAS: QCV Assay 7-7 VIDAS: QCV Assay 7-7 Temperature Validation 7-8 Purpose & Definition of Terms 7-8 Temperature Tolerances of the VIDAS and MINI VIDAS Analyzers 8 Trays 8 SPR Blocks 8 Materials 7-8 Measurement Instrument 8 Accessories 8 Methodology 7-8 Testing the Trays Temperatures 9 Testing the SPR Blocks Temperatures 9 Results Sheet 7-9 VIDAS Pump Tester (Part no. 4530120A) Procedure for Use 7-11 Introduction 7-11 Characteristics 12 Technical Characteristics 12 Presentation of the VIDAS Pump Tester (VPT) 712 Recommendations for Use 7-14 Testing the Pumps 7-15 Initializing Measurement 18 Cleaning and Decontamination Procedure 7-20 Before Use 20 Each Time the VPT is Decontaminated (every 6 months and before metrological testing or maintenance) 20 Procedure for Returning the VPT for Metrological Testing or Maintenance 7-21 Pump Tester Verification Date 22 Scope 22 Information 22 VIDAS Pump Tube Cleaner 7-23 Introduction 7-23 Specifications 7-24 Technical Specifications 24 Environmental Specifications 24 Description 7-24

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Operation 7-26 Precautions for Use 26 Installation of the Drill Bit on the Motor 26 Cleaning the Pump 28 Acceptance Criteria 30 Additional Procedures 7-31 Cleaning and Decontamination 31 Decontamination of the Sleeve/Drill Bit Assembly 31 Decontamination of the VPCT Tool 31 Decontamination of the Insertion Guide 32 Battery Replacement 32 Repair 33 VIDAS Alignment Tool - Procedure for Use and Realignment 7-34 Using the VIDAS Alignment Tool 7-34 Introduction 34 Presentation of VIDAS Alignment Tool 7-35 Precautions for Use 36 Checking Alignment 36 Cleaning and Decontamination Procedure 40 Before Use 40 After Use 41 Realignment 7-41 Prerequisite 41 Introduction 41 Checking Slide Block Alignment 42 Checking Tower Phasing 44 Correcting Left/Right Misalignment 44 After Correcting Left/Right Misalignment 45 After the Ball Plunger has been Verified/Adjusted 45 Correcting In/Out Misalignment 46 QCV After Realignment 48 Table of Spare Parts 7-48 VIDAS Inter-Tray RFV Adjustment 7-50

HP Business Inkjet 1100d Printer (C8124A) Specifications and Warranty 8-11 Specifications and Warranty 11 HP LaserJet 2015dn 8-13 Consumables 13 Warranty 13 Cables 8-14 Null-modem Cable (Ref. 451 1251A) 8-14 VIDAS PC Host Cable (Ref. 93426) 8-14 Fuses 8-15 mini VIDAS Fuses List 8-15 Pinout Serial to IF Terminal (Ref. 186009-1) 8-15

9 9. Optional bioMérieux Equipment VIDAS Heat And Go - INDUSTRY What is the VIDAS® Heat And Go? Product references 4 CD User Manual VIDAS Heat And Go P/N 93557 4 Accessories and Consumables 4 Contacts for Technical Support Assistance Training and Installation MOVEX Codification 5 WTO - Where to Order Document Warranty Spare Parts Metrology Preventative Maintenance Temperature Verification Tools 7 Method 7 Troubleshooting Appendix 1

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9-4 9-5 9-6 9-6 9-7 9-7 9-7 9-7

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8 8. Spare Parts And Consumables Spare Parts Compatibility And Accessories 8-2 mini VIDAS and VIDAS (Grey and Blue) - Spare Parts Compatibility Table 8-2 Printers 8-8 LEXMARK Consumables References 8-8 Scope 8 Information 8 HP 1320 Specifications and Consumables 8-9 HP Laser Jet 1320n Specifications 9 Warranty 11 Consumables 11

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User Manual

1. How To Use This Manual

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1. How To Use This Manual • Scope of the Manual • Organization of the Manual • Typographic Conventions • Layout and Functions of the HTML Service Manual • Glossary and Abbreviations

VIDAS and mini VIDAS Service Manual

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1. How To Use This Manual Scope of the Manual

Scope of the Manual This manual is for use by bioMérieux Field Service Engineers and factory trained Biomedical Engineers to assist in the troubleshooting and repair of the VIDAS and mini VIDAS system. Every effort has been made to ensure that the information contained in this manual is complete and accurate. All calibration and adjustment procedures used in this manual are adapted directly from current Engineering documentation or manufacturers' supplied documentation. This Service Manual contains information on the operation, installation, maintenance, and repair of the VIDAS and mini VIDAS. This information is intended to provide an understanding of how these instruments perform, possible causes of malfunctions, and how to isolate and correct performance problems.

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VIDAS and mini VIDAS Service Manual

1. How To Use This Manual Organization of the Manual

Organization of the Manual The information in the manual is organized among eight chapters, arranged so that the information you need first is in the beginning of the manual. Information required for maintenance after the system is operating, is found in later chapters. The following is a brief outline of what you will find: • Chapter One: How to use this manual - This chapter explains how the manual is organized and how to use the manual. • Chapter Two: General Description - Use this chapter to familiarize yourself with the VIDAS and mini VIDAS hardware and the basic parts of the software system. This chapter describes the Reagent Strips and other parts of the assay kits you use with the system. • Chapter Three: Installation and Setup - This chapter is a complete guide for the installation and setup of the VIDAS and mini VIDAS. It begins with the unpacking of the instrument and proceeds through its power up, configuration and software installation. This chapter also contains environmental, space, and electrical requirements, along with instructions for connecting external options. • Chapter Four: System Composition - This chapter describes the systems and their components, peripherals and their operation. It contains the descriptions of the boards and major subassemblies. • Chapter Five: Maintenance - This chapter contains several different types of procedures, for decontamination and cleaning, mechanical and electronic alignment and calibration of subassemblies in the systems. This chapter also describes the error reporting system, the error messages you will see, and how to respond to error conditions. This chapter also describes how to perform Preventive Maintenance on the VIDAS and mini VIDAS, and provides a checklist that can be used for recordkeeping. This chapter describes It also describes how to remove and install the subassemblies that you may encounter during repair of the VIDAS and mini VIDAS. • Chapter Six: Troubleshooting - This chapter contains instructions and procedures to solve hardware and software related errors and malfunctions on the systems. • Chapter Seven: Quality Control / Specific Tools / Metrology - This chapter contains procedures for performing various Quality Control Tests using specific tools and procedures. • Chapter Eight: Spare parts and consumables - This chapter describes all parts and materials used with the systems and their compatibility. All reference numbers can be found for re-ordering parts. • Chapter Nine: Optional BioMérieux equipment - This chapter describes optional devices and equipment available from BioMérieux. Following these chapters are appendices listing procedures for decontamination and routine cleaning; board layouts and schematics. You will also find a glossary of terms in the back of the manual.

VIDAS and mini VIDAS Service Manual

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1. How To Use This Manual Layout and Functions of the HTML Service Manual

Layout and Functions of the HTML Service Manual The electronic HTML service manual for VIDAS and mini VIDAS uses standard internet browsers for display. The general layout of the HTML service manual is displayed below.

Figure

HTML service manual displayed in an internet browser

A

Internet browser functions

B

Contents tab

C

Search tab

D

Table of contents for navigation within the HTML service manual

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Field to enter search text

F

Click on this icon to display copyright and version information

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Manual content

The Contents tab The Contents tab shows the complete table of contents of the HTML service manual and can be used to browse through the content.

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VIDAS and mini VIDAS Service Manual

1. How To Use This Manual Layout and Functions of the HTML Service Manual

Figure

Contents tab Contents tab not active. Click this button to display the Contents tab. Contents tab is displayed.

Click this button to hide the Contents (or Search) tab. Closed chapter or subchapter. Click to open. Opened chapter or subchapter showing its contents below in the content tree. Topic without further subchapters. Click to display the content.

The Search tab The Search tab allows a full text search within the HTML service manual contents.

VIDAS and mini VIDAS Service Manual

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