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VITEK 2 Systems Online Software User Manual

1. 12 6 Unused Connection 12 6 Transaction Logis Si ega ei ee leh eee ES Male predv klena 12 7 Search Transaction Log 12 7 Deleting Transaction Log Messages 12 8 Printing Uploaded Messages 12 9 Link Operation Ae Rite SE erh Ede IAE e 12 9 Start Stop the Connection 12 10 Transmission of Results Upload 12 11 Reception of Data Download 12 11 Results on Hold Back in Service Out of Service 12 11 View Link History 12 12 Viewing Real time Interface Connection 12 13 Link Configuration ss 1 de Eed SEN Nee Gane 12 14 Le 12 20 BCI Alarm Status Icons 12 21 View and Maintain BCI Status and Alarms 12 21 Current BCI Alarm Report 12 24 BCI Alarm History Report 12 25 VITEK 2 Systems Software User Manual vii 510773 3EN1 Table of Contents BCI Configuration Settings 12 25 General BCI Configuration Settings 12 26 BO Unload EE EE 12 27 BCI Download Tab
2. 12 28 BCI Translation Tab 12 30 VOGEL 13 1 Create and Maintain User and Security Settings 13 2 Initial User Accounts 13 2 Creating User Accounts 13 3 Adding User IDs to User Groups 13 4 Creating AST Card Definitions 13 5 Deleting a Card Definition 13 6 Maintain AST Card Definitions 13 7 Archive Isolate Reports and Isolate Audit Trail 13 8 Archiving Isolates 13 8 Archive Isolates i ek A EEN ake C EK AERE outa REICHEN 13 9 What Happens to Deleted Isolates 13 9 Archiving Isolates to a CD 13 10 Too Many Isolate Reports for One CD 13 11 Viewing and Searching Archived Isolate Reports 13 11 Search Audit Trail 1 2 sil cese e aede oed eared ador 13 13 Searching Audit Trail by Isolates or by the Application System 13 13 Saving Audit Trail to a CD 13 16 Exporting Results and Raw Data to Electronic Media 13 16 Print Audit Trail Reports
3. 9 5 Results Validation Configuration 9 6 Critical Isolates eren is dreet de bd ee Maes 9 6 Configuring Result Validation 9 7 VITEK 2 Systems Software User Manual v 510773 3EN1 Table of Contents Part IV Configure the Workstation and Maintain System Utilities CONFIGURE AND MAINTAIN WORKSTATION s aaanaenananaanananananaanananananananananananananananana 10 1 Accessing Configuration Views 10 2 Unlock Lock Configuration View for Changes 10 3 Save or Cancel Configuration Changes 10 4 General Configuration 10 4 Customizing General Configuration Supervisor Only 10 5 System lnformation 10 5 System Mode and Options 10 6 Setting the System Mode 10 7 Customizing the Inactivity Timer 10 7 Moving Isolates to Inactive 10 7 Maximum Logon Attempts 10 8 Print Settings EE 10 8 Miscellaneous 5 3 ese tis ipods aladdin oh aa 10 9 Setting Up and Creating New Benches Clinical Use 10 9 Add a Bench Name
4. 3 4 View and Acknowledge Detected Alarms 3 6 View Alarm History 0000 0c eects 3 7 Part Il Set Up and Manage Test Information SET UP TEST CARDS AND CASSETTE INFORMATION a aaananunennnnananasanananaanananasananana ananasa anam 4 1 VITEK 2 Systems Workflow 4 2 Using the Set Up Tests Post Entry Workflow 4 2 Filtering Cassettes 4 4 Printing a Blank Cassette Worksheet 4 4 Preparing Test Cards and Cassettes 4 5 Viewing Cassette Information 4 5 Defining the Selected Cassette 4 6 Defining the Cards in the Cassette 4 7 Entering Cassette Worksheet Information 4 8 Defining Isolate Group Information 4 10 Saving Cassette Information 4 11 Printing Cassette Information 4 12 Cassette Reports Virtual SCS or Post Entry 4 13 Blank Cassette Worksheet 4 14 Editing Modifying Cassette Information 4 14 Ejecting Cards from Instrument 4 15 Using the Vir
5. 11 11 Customizing MIC Interpretation Guideline 11 12 vi VITEK 2 Systems Software User Manual 510773 3ENI Table of Contents Modifying Breakpoints for a Custom Interpretation Guideline 11 13 Updating a Breakpoint 11 14 Adding a Breakpoint Set 11 14 Delete Breakpoint Set 11 15 Sorting Information 11 15 Viewing Therapeutic Interpretation Guideline 11 16 Sorting Information 11 19 Creating a Custom Therapeutic Interpretation Guideline 11 19 Modifying Custom Therapeutic Interpretations 11 19 Add Therapeutic Interpretation 11 20 Delete Therapeutic Interpretations 11 21 Printing User Change Report 11 22 CONFIGURE AND MAINTAIN BCL ccccsssssssssssssssssssssessnssssesssssesssveesesseaeeauaeaeaeauoeseaeosseseauaues 12 1 IntrOdUCHON 1 5 23 ty eh at eh ayaa ES REOR RON eh 12 2 View and Maintain Connection Status 12 2 SUPETVISION 2 SHEI de A A era dred ered we ea eG aA a nas 12 4 Status of the Connection 12 5 Alarm Connection
6. 14 6 Cumulative Patient Isolate and Audit Management Isolate Reports 14 6 Cumulative QC Isolate and Audit Management Isolate Reports 14 7 Deleted Isolates in the Inactive Workspace 14 7 Application Audit Trail Management 14 7 Restore Isolate Data Supervisor Only 14 7 Restore Failure 14 9 APPENDIX A BLANK CASSETTE WORKSHEET mmmmrrrarararnnanannnanannnnnanananananannennnnnenenenenenennnen A 1 VITEK 2 Compact Blank Cassette Worksheet cece eee eee A 1 VITEK 2 Blank Cassette Worksheet A 2 INSTA HIE B 1 APPENDIX C AES ANTIBIOTIC DEDUCTION RULES mrrrmnnnnnnnenennnnnnnnnenenenenennnt C 1 GLOSSARY smsmrmrramunannnnnunannnnnanannnnnanenananannnananannennnnnnnnnnnnnnnenenenenenenenenenenenenenenenenennnes GLOSSARY 1 INDEX INDEX 1 VITEK 2 Systems Software User Manual 510773 3EN1 Table of Contents D VITEK 2 Systems Software User Manual 510773 3ENI LIST OF FIGURES Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 3 1 Figure 3 2 Figure 3 3 Figure 3 4 Figure 3 5 Figure 3 6 Figure 3 7 Figure 3 8 Figure 4 1 Figure 4 2 Figure 4 3 Figure 4 4 Figure 4 5 Figure 4 6 Figure 4 7 Figure 4 8 Figure 4 9 Figure 4
7. 5 6 Moving Specimens 5 6 Searching Inactive Reports 5 6 Printing Reports v di nija iki ee Rg alae e PE de ie die 5 8 MAINTAIN SUPPLEMENTAL REACT FILE INDUSTRIAL USE 6 1 Introduction to SRF Industry Use 6 2 Copy Biopatterns to SRF 6 2 Criteria for Merging ID Results with SRF Results 6 4 Creating and Maintaining SRF Organisms Supervisor 6 5 Viewing and Maintaining SRF Data 6 5 Creating SRF Organisms 6 7 Viewing and Maintaining SRF Organism Information 6 9 Deleting SRF Organisms 6 9 Maintaining Unassociated SRF Biopatterns 6 9 Viewing Unassociated Biopatterns 6 10 Deleting an Unassociated SRF Biopattern 6 10 Linking Associating Biopatterns with SRF Organisms 6 11 Associating a Biopattern to an Existing Organism a 4 6 11 Unassociating Biopatterns from SRF Organisms 6 13 View SRF Biopattern Associations for an Existing SRF Organism 6 14 Activating SRF Organisms 6 14 Deactivating SRF Org
8. 10 9 Delete a Bench gun sa nage dansant titine ne 10 9 Modifying Organism Quantity 10 10 Modify Organism Quantity Text 10 10 Enabling Patient Demographics Clinical Use 10 10 Enabling Automatic Daily Backup 10 10 Viewing Versions of Installed Components 10 11 VIEW AND CONFIGURE AES ccsssssssssssssssssesssssesesescsesususcsesnsssnessusnensneusnsssesueneveneueneneneneaessuen 11 1 Accessing AES Configuration 11 2 Parameter Set Information 11 4 AES Configuration View 11 6 AES Parameter Set Definition 11 6 Values sep ded hate done eed eye i ue pe AREA 11 6 Ded ctions 52e edge CLADE De DLE E ER ER 11 7 Deduction by Phenotype 11 7 Equivalent Deductions 11 7 Bettinger iiie vocor d dae La epe ER ee hee ee 11 8 Activating a Parameter Set 11 8 Creating Custom Parameter Sets 11 9 Creating a Custom Parameter Set 11 10 Deleting Custom Parameter Sets 11 11 Viewing MIC Interpretation Guideline
9. 13 17 DATA BACKUP AND DAILY MAINTENANCE mmrrmrmanannmunanannnanannennanannennannnnnnnnnnnnannenenenenenenenen 14 1 Backup Isolate Data 14 2 Recommended Backup Strategy 14 2 Daily sa mines Re tele sete die ER 14 2 Week 52 ri Sek gleef dites inde in getut ebe 14 2 Long Term Storage 2 me o deena ep enr MU ERSTES 14 2 Automatic Backup 14 3 CD Fail re asser idea LR RO Rp P RR Sen dl red 14 3 Laboratory Technologist Initiated Isolate Data Backup 14 3 End of Day Processing and Daily Maintenance 14 4 End of Day Processing Begins 14 4 Complete Daily Workspace Maintenance 14 4 Patient Information Cleanup 14 5 Isolate Information Cleanup 14 5 QC Management Cleanup 14 5 viii VITEK 2 Systems Software User Manual 510773 3ENI Table of Contents Cassette Management Cleanup 14 6 Instrument Status Management Cleanup 14 6 Alarm Management Cleanup 14 6 Deleted Isolates Cleanup 14 6 Maintain Inactive Workspace
10. 1 8 Table of Symbols 1 10 GETTING STARTED sememenenenenennnunenennnenennnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannennnnannenenneennnnnnennntannenes 2 1 System Software Navigation Introduction 2 2 Basic Navigation 2 2 Working in the Software Views 2 3 Main Hiewel nee 2 3 Main Navigation Areas of the System Software 2 5 Accessing the System Software 2 6 Starting the System Software 2 6 VITEK 2 Systems Software User Manual i 510773 3EN1 Table of Contents Logging tee Zeche et EA Sa E E Rea 2 8 Logging Out or Quitting the Application 2 9 Changing Users jou ans ane Se Cah ee honed Aula a Gate gie Alae 2 10 Managing the Inactivity TImer 2 10 Customize the Inactivity Timer 2 10 INSTRUMENT AND SYSTEM STATUS sssssssssssssssssesesesssesesesssnsnsusnsesnsnsssesuenesensuensssnenssesenenenenenes 3 1 View and Maintain Instrument Status 3 2 Instrument Alarm Status Icons 3 3 View and Print Current Instrument Status 3 3 View Instrument Monthly Status
11. Bach Cassette Worksheet tor VITEKI 4 VITEK 2 technology Figure 4 9 Print Cassette Report 4 12 F VITEK 2 Systems Software User Manual 510773 3EN1 Set Up Test Cards and Cassette Information Defining the Selected Cassette Cassette Reports Virtual SCS or Post Entry You can print the isolate information related to the cassette by printing the cassette report Note A Cassette ID of O zero indicates that the instrument was not able to read the cassette bar code and the Cassette ID was not yet selected Wu Cassette Report Preview bla rka C ustamer 120454793 Cassette Report Printed Jani 2004 1521 General Information Instrument Simulator Load Time 2003 11 26T12 30 00 Cassette Information Cassette ID 1 Bench Name Urine Setup Tech Name Ren Super Sas 2410100001094733 101 1 Esch coli 2420100001124971 1021 Entero faecalis 103 1 Str pneumoniae 105 1 2410100001063596 106 1 Low Discrim 2420100001070377 1071 lt lt Stashline gt gt 2420100001071724 1081 lt lt Slashline gt gt DmPageiofi1 E85x110in Figure 4 10 Example Cassette Report VITEK 2 Systems Software User Manual 4 13 510773 3EN1 Defining the Selected Cassette Set Up Test Cards and Cassette Information Blank Cassette Worksheet From within the Setup Tests Post Entry view you can print Blank Cassette Worksheets Use a blank cassette worksheet to record
12. Index 2 VITEK 2 Systems Software User Manual 510773 3ENI Index transaction log 12 2 function of 12 1 installed with system software 12 2 status and alarms BCI alarm history 12 23 BCI alarm status icons 12 21 current BCI alarms 12 22 status icon 12 21 view connection status 12 6 current connection status 12 3 BCI Alarm History Report 12 25 BCI Alarm Icon 12 3 BCI Alarm Status and History Window 12 22 BCI Alarm Status Icons 3 3 12 21 Bench Name 4 6 4 8 4 23 select new 8 15 Bidirectional Computer Interface See BCI Bionumber 8 15 Biopattern copy to SRF database 6 3 8 29 Blank Cassette Worksheet enter information from 4 8 enter isolate information from 5 5 print 4 4 use 4 14 Breakpoint add set 11 14 customize 11 14 delete set 11 15 modify MIC value of 11 14 C Card bar code antibiotics contained on card 15 7 from package insert 15 6 information about Glossary 2 missing bar code 4 11 order on insert 15 7 read by instrument 4 7 4 19 scanned or entered manually 15 7 change AST card definitions 15 7 isolate number for card in isolate group 8 12 defined in active workspace 4 7 4 9 delete card definition 15 6 detailed information in cassette workspace 4 6 eject from instrument 4 15 lot 7 13 move to another isolate group 8 26 new card definition added 15 6 organism name for AST cards 4 9 organism quantity 4 9 package insert 15 7 QC ID card details report 7 17 set AST card ejection time 9
13. From the General Configuration view you can view and maintain the general settings To customize the general settings you need to unlock this screen for changes For details see Unlock Lock Configuration View for Changes on page 10 3 NE General Configuration Macivty Timer mn fo z Move isolate to inactive days D zj VITEK 2 technology Figure 10 6 General Configuration View System Information The system information pertains to the user customer laboratory specific information and information about the instrument s connected to the system software VITEK 2 Systems Software User Manual 10 5 510773 3EN1 System Mode and Options Note Configure and Maintain Workstation The system information includes Facility Name Customer Number System Number Instruments This includes the Instrument Serial Number and Instrument Name entered at the Instrument These fields are not editable from the system software The facility name entered here appears on all Laboratory Reports NE General Configuration Figure 10 7 System Information System Mode and Options The system mode allows you to change the system settings and set system parameters for general features ex Maximum Logon Attempts Note To enable SRF you need to select Industry Mode from the General Configuration view as well as enable SRF from the ID Configuration view The system mode o
14. Salmonella group Salmonella ser Gallinarum Salmonella ser Paratyphi A Salmonella ser Typhi Serratia ficaria Serratia fonticola Serratia liquefaciens group Serratia marcescens Serratia odorifera Serratia plymuthica Serratia rubidaea VITEK 2 Systems Product Information 1 15 069041 4EN1 Organisms Identified by the GN Card GN Product Information Shigella group Shigella sonnei Yersinia enterocolitica group Yersinia pestis Yersinia pseudotuberculosis Yersinia ruckeri Yokenella regensburgei Non Enterobacteriaceae Achromobacter denitrificans formerly known as Achromobacter xylosoxidans ssp denitrificans Achromobacter xylosoxidans formerly known as Achromobacter xylosoxidans ssp xylosoxidans Acinetobacter baumannii Acinetobacter haemolyticus Acinetobacter junii Acinetobacter lwoffii Actinobacillus ureae Aeromonas hydrophila Aeromonas caviae Aeromonas salmonicida Aeromonas sobria Aeromonas veronii Alcaligenes faecalis ssp faecalis Bordetella bronchiseptica Bordetella trematum Brevundimonas diminuta vesicularis Brucella melitensis Budvicia aquatica Burkholderia cepacia group Burkholderia gladioli Burkholderia mallei Burkholderia pseudomallei CDC group EF 4 Pasteurella Chromobacterium violaceum Chryseobacterium gleum Chryseobacterium indologenes Chryseobacterium meningosepticum Comamonas testosteroni Delftia acidovorans Francisella tularensis Grimontia
15. Table 3 5 Non Reactive Species Candida sake Candida zeylanoides Malassezia furfur Malassezia pachydermatis Zygosaccharomyces bailii 3 8 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Quality Control Quality Control Quality control organisms and their expected results are listed in the VITEK 2 YST Quality Control Table and should be processed according to the procedure for test isolates outlined in this document The YST card will identify the quality control organisms as one choice or within a low discrimination or slashline identification See the Quality Control Section for more details Frequency of Testing Note Currently it is recommended that you use your most stringent inspecting agency s guidelines for frequency of identification product testing Common practice is to perform QC upon receipt of shipment of the test kits Reactions must follow Product Information results If the results do not meet the criteria subculture for purity and repeat test If discrepant results are repeated perform an alternate identification method The recommended and supplemental QC strains do not exhibit a negative reaction for two tests LeuA and dGLU These tests serve as a positive control for most taxa claimed by the YST card Reproducible negative reactions are only observed with strains of Malassezia spp Malassezia was not included for QC since cultur
16. To view and maintain patient information 1 From the Main view or from the navigation bar click Enter Manage Patient Information view Figure 5 1 Enter Manage Patient Information View 2 The View and Maintain Patient Information view appears Y View and Maintain Patient Information de Patient We 087854321 Fe Mame David Sem D Locations 100 ftezprwtory ioni 110 Mound Comment VITEK 2 technology Figure 5 2 View and Maintain Patient Information 3 You can view by and filter by the patients and specimens that appear in the navigation tree 4 From the first drop down list that appears in the navigation tree select whether you want to view by Patient Name or Patient ID 5 2 VITEK 2 Systems Software User Manual 510773 3EN1 Manage Patient Information Clinical Use Adding Patients 5 From the second drop down list select whether you want to see All Specimens Only Specimen With Isolates or Only Specimens Without Isolates Adding Patients When you view and maintain patient information you can add patients to the system software 1 From the View and Maintain Patient Information view click Add Patient Figure 5 3 Add Patient Specimen Icon 2 Enter the patient information in the Add Patient window Note The patient must have a unique ID and an alternative unique ID 3 Fill in the following fields Patient ID required and must be unique Altern
17. To view the details click the View Reconciliation Details icon Figure 4 16 View Reconciliation Failure Icon Note The reconciliation details icon is only available when there is a reconciliation failure Deleting a Virtual Cassette If you have not loaded the cassette into the instrument you can delete the pre defined Virtual Cassette To delete the virtual cassette 1 Select a Virtual Cassette from the navigation tree 2 Click Delete Virtual Cassette A confirmation window appears VITEK 2 Systems Software User Manual 4 19 510773 3EN1 Using the Virtual Cassette Workflow Set Up Test Cards and Cassette Information Confirm deleting the selected virtual cassette 11 F freminan 4 VITEK 2 technology Figure 4 17 Delete Virtual Cassette 3 Select whether you want to terminate the tests that were set up for the deleted Virtual Cassette Note Terminating the test cards means you cannot reuse the test cards that were set up with that particular Virtual Cassette 4 The Virtual Cassette definition is deleted 5 The Virtual Cassette ID is now available for reuse since the system deleted the definition for that ID 4 20 VITEK 2 Systems Software User Manual 510773 3EN1 Set Up Test Cards and Cassette Information Using the Smart Carrier Station SCS Using the Smart Carrier Station SCS IMPORTANT The Smart Carrier Station workflow can only be used with a VITEK 2 Instrument
18. Expert See Advanced Expert System Expiration Date The last date on which a Test Card can be used each lot number receives a value supplied at time of manufacture Filter A type of search criteria used to limit information displayed in a view Final An indication that a test or exam s result is complete Hour of call The hour a card result becomes final ID test card A test card that identifies microorganisms Instrument A VITEK 2 instrument used to process tests by the insertion of Cassettes Test Cards Instrument Parameters Operating parameters for the VITEK 2 instruments such as incubation temperature wavelength and optical spectra used Instrument Raw Data Raw transmittance units RTU expressed as a number between 0 and 4095 Interpretation A category call such as S susceptible intermediate or R resistant that is applied to an MIC result Interpretation Guideline A parameter allowing users to select sets of expected therapeutic interpretation and antibiotic deduction rules eg CLSI CA SFM and Natural Resistance Interpretation set or A set of antibiotic Susceptibility Category breakpoints standard recommended by a recognized consensus committee Isolate A bacterial microorganism recovered from a clinical or industrial specimen that is potentially Pathogenic Isolates recovered from the same culture are distinguished from each other by an Isolate Number assigned by the Lab Tech e g 1 E coli an
19. 1 3 Results ee dr ER Ae eee wee RE ee ER 1 4 Identification Analytical Techniques 1 4 Identification Card Qualifying Message 1 6 Percent Probability 1 6 Additional Information on Lab Report 1 7 Notes Associated with Certain Taxa 1 8 Notes Associated with Improperly Filled Card or Negative Profile biopattern 2 secutum ue err 1 8 Quality Control 1 9 Frequency of Testing 1 9 Testing and Storage of QC Organisms 1 10 Storage Conditions 1 10 GN Quality Control Table 1 11 Limitations iu i ker EA ed Zeene AEN ERIS 1 14 Performance Characteristics 1 14 Organisms Identified by the GN Card 1 14 Enterobacteriaceae 1 14 Non Enterobacteriaceae 1 16 Highly Pathogenic Organisms 1 17 GN Well Contents 1 18 GN Supplemental Tests 1 20 Culture Requirements Table 1 24 Culture Requirements Table Media Abbreviations 1 25 Bibliography 1 26 GP PRODUCT INFORMATION 2 1 Intended Lee ie ii e upa NIR el etii p
20. 10 Insert the appropriate CD Note Ifa CD is not already inserted a message appears asking you to insert a CD 11 The View Archived Lab Reports or Isolate Audit Trail window appears 12 In the report type select Lab Report or Isolate Audit Trail 13 12 VITEK 2 Systems Software User Manual 510773 3EN1 System Utilities Search Audit Trail 13 If a Lab Report is selected select the specific version of the lab report and click Print 14 If the report is an Isolate Audit Trail click OK and the Isolate Audit Trail window appears Click Print or Export to proceed Search Audit Trail The audit trail search function allows you to track the system history as well as the history of individual isolates You can also search an Archive CD for archived data Searching Audit Trail by Isolates or by the Application System There are multiple types of search criteria to help you refine your audit trail search To search the audit trail 1 From Main view select Utility View and then click Search Audit Trail Maintain AST Card Definitions Search Audit Trail Archive and View Archived Reports Figure 13 6 Search Audit Trail 2 Select either Isolate or Application system as the Search Type VITEK 2 Systems Software User Manual 13 13 510773 3EN1 Search Audit Trail System Utilities NU scarch Audit Trail ba mm 1218 lom 2 2002 vm 1 VITEK 2 techn
21. AST NOIT AST MIO bat AST NU22 fastas JASTA betwe Water ten stage ST NTO CH Figure 9 2 AST Configuration View Card Ejection When configuring AST analysis you can set the AST card ejection time There are two options Maximum Card Incubation Default Hour of Call Deducing Antibiotics When configuring AST card analysis you can select drugs to deduce based on AST cards To do so follow these steps 1 From within the AST Configuration view unlock the view to make changes 2 Scroll to the AST card that you would like to modify 9 4 VITEK 2 Systems Software User Manual 510773 3EN1 Configure Results Analysis and Review Configuring AST Analysis 3 4 5 6 Select Edit A window appears displaying antibiotics to deduce Select the antibiotics to deduce and click OK Be sure to save and lock your changes before moving on to the next view Suppressing Antibiotics VITEK 2 Systems Software User Manual 9 5 510773 3EN1 When configuring AST card analysis you can select antibiotics to suppress based on AST cards Note If an organism antibiotic combination is suppressed when AST analysis is complete and AES is performed the results appear in the active workspace and on the lab report However the results do not appear on the Chart Report and results are not sent to LIS To suppress antibiotics 1 2 3 4 5 6 7 8 From within the AST Configuration v
22. Not Qualified Reviewed Approved Aged from Active Workspace Deleted Isolates 21 CFR 11 Enabled Aged from Active Workspace What Happens to Deleted Isolates When 21 CFR 11 is enabled deleted isolates are not deleted they are flagged as Inactive and moved to the inactive workspace When the user creates an archive CD deleted isolates are copied with other isolates and QC to the archive CD Archive Isolates System Utilities Archiving Isolates to a CD Note It is recommended that you use read only media for example CD R for archiving isolate reports and audit history to prevent overwriting the archive information To archive isolates 1 From the Main view select Utilities view gt Archive and View Archived Reports Figure 13 4 Archive Isolate Reports and Audit Information 2 Click the Archive Isolate Reports and Audit History icon A prompt to enter a blank CD will display 3 Insert a blank CD and wait for the green light to disappear 4 Select Yes to continue Note Ifa CD is not already inserted a message appears asking you to insert a blank CD 5 The Isolate Reports are copied onto the archive CD 6 The following information is archived to the CD Current Isolate Report Previous Isolate Report Versions if 21 CFR 11 is enabled Isolate Audit entire audit since last archive Application Audit 7 If there are too many Isolate Reports for one CD or the CD is full
23. Note To enable SRF analysis the system must be set to Industry mode and you will need to select the check box beside Enable SRF Analysis in ID Configuration view Setting the Time to Eject Analyzed Cards When you change the time to eject completed and analyzed cards you can select the following options from the drop down list e Hour of Call default The hour a card s results become final Max Card Incubation The maximum incubation time for a particular card Configuring AST Analysis AST analysis determines MIC values from instrument raw data collected from a susceptibility card You can configure AST Analysis Susceptibility configuration consists of the following tasks Select antibiotics to deduce Select organism antibiotic combinations to suppress Define the time for card ejection max incubation hour of call VITEK 2 Systems Software User Manual 9 3 510773 3EN1 Configuring AST Analysis Configure Results Analysis and Review Accessing AST Analysis Configuration To access AST Analysis Configuration 1 From the Main view select AST Configuration from the Configuration drop down menu 2 The AST Configuration view appears WAST Configuration Gover al Confegur ation AST Cara Becton bes ot Cat z Artibictics to Deduce arencecs to Suporer Card Type WASTE Steen razi W I At Isi 0 Astana asT cano AST CPSS bat omg AST CESS AST D1O JASTA baten sro astama
24. The Smart Carrier Station SCS is an independent piece of hardware that allows you to define cassette and isolate information prior to loading a cassette into a VITEK 2 Instrument A cassette created with a Smart Carrier Station will retain all user defined isolate information and can be transferred and read by a VITEK 2 instrument The VITEK 2 instrument will identify the information from a Smart Carrier Station cassette and transfer the data to the VITEK 2 Systems software The VITEK 2 Systems software will automatically link ID and AST cards from Smart Carrier Station cassettes using the Lab ID and isolate number This workflow outlines all of the steps required to prepare a specimen and a VITEK 2 card and to process that card through the VITEK 2 instrument using the Smart Carrier Station 1 Prepare a pure culture of the organism according to the Culture Requirements Table 2 Use the VITEK 2 DENSICHEK to prepare the appropriate organism suspension 3 Take the suspension to the Smart Carrier Station 4 Make sure that all configuration items on the SCS are set correctly See the VITEK 2 Instrument User Manual 5 Enter the data for the culture and the test card and place the suspension test tube and the test card in the appropriate slot of the cassette See the VITEK 2 Instrument User Manual 6 Repeat Step 5 for the other suspensions and test cards for this cassette 7 Remove the cassette from the SCS and t
25. This setting allows you to set the number of days an isolate remains available in the active workspace The default is seven days and the available range of days to move isolates to the inactive workspace is from three to 30 days Note Do not reuse Laboratory IDs during the time that the isolates with that Laboratory ID remain in the active workspace VITEK 2 Systems Software User Manual 10 7 510773 3EN1 Print Settings Configure and Maintain Workstation Isolates that meet the following criteria will be considered eligible to be moved to the inactive workspace Final Isolates Isolates Not Qualified Isolates that do not need to be reviewed or approved Isolates that cannot be edited are in the inactive workspace The inactive workspace acts as a repository for laboratory reports and QC laboratory reports The inactive workspace is maintained by user configuration Maximum Logon Attempts This setting allows you to set the maximum number of logon attempts before a user is locked out of the system The default is three attempts The maximum attempts can range from two to eight Print Settings There are two global print settings that you can enable from within the General Configuration view They include Automatically print lab report after analysis When enabled a laboratory report automatically prints when the isolate has completed analysis Prompt for lab report after qualified validated When enabled the p
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27. 127287 Moscow tel 7 095 212 10 26 7 095 424 79 38 fax 7 095 214 95 41 Spain bioM rieux Espa a S A Manual Tovar 45 47 28034 Madrid tel 34 91 358 11 42 fax 34 91 358 06 29 Distribution in over 130 countries Sweden bioM rieux Sverige AB Hantverksv gen 15 436 33 Askim tel 46 31 68 84 90 fax 46 31 68 48 48 Switzerland bioM rieux Suisse s a 51 avenue Blanc Case postale 2150 1211 Gen ve 2 tel 41 22 906 57 60 fax 41 22 906 57 42 Taiwan Representation Office bioM rieux 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 bioM rieux 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 bioM rieux Diagnostik A S De irmen Sok Nida Plaza Kat 6 34742 Kozyata i Istanbul tel 90 216 444 00 83 fax 90 216 373 16 63 United Kingdom bioM rieux UK Ltd Grafton Way Basingstoke Hampshire RG22 6HY tel 44 1256 461881 fax 44 1256 816863 USA bioM rieux Inc 100 Rodolphe Street Durham NC 27712 tel 1 919 620 2000 fax 1 919 620 2211 Vietnam Representation Office bioM rieux Vietnam 17 Nguyen Van Mai Ward 8 District 5 Ho Chi Minh City tel 84 88 299 599 fax 84 88 207 898 Warranty bioM rieux Inc disclaims all warranties express or implied including any impli
28. 3 Use a sterile stick or swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in step 2 Prepare the homogenous organism suspension with a density equivalent to a McFarland No 1 80 to 2 20 using a calibrated VITEK 2 DENSICHEK Note Age of suspension must not exceed 30 minutes before inoculating card 4 Place the suspension tube and BCL card in the cassette 5 Refer to the User Manuals for the VITEK 2 Instruments for instructions on data entry and how to load the cassette into the instrument 6 Follow your local inspecting agency s guidelines for the disposal of hazardous waste Identification Analytical Techniques The identification of an organism using the VITEK 2 systems uses a methodology based on the characteristics of the data and knowledge about the organism and reactions being analyzed Sufficient data have been collected from known strains to estimate the typical reactions of the claimed species to a set of discriminating biochemicals If a unique identification pattern is not recognized a list of possible organisms is given or the strain is determined to be outside the scope of the database The printed lab report contains suggestions for any supplemental tests necessary to complete the identification If the tests are not sufficient to complete the identification then standard microbiology references and literature should be consulted Certain species may belo
29. Acinetobacter baumannii And One of the following antibiotics has been tested CIPROFLOXACIN OFLOXACIN PEFLOXACIN And The result is S Then The result can be reported for CIPROFLOXACIN LEVOFLOXACIN OFLOXACIN PEFLOXACIN SPARFLOXACIN RULE 9 INTERPRETATION GUIDELINES PHENOTYPIC Active If Staphylococcus And One of the following antibiotics has been tested CIPROFLOXACIN LEVOFLOXACIN OFLOXACIN PEFLOXACIN Then The result can be reported for CIPROFLOXACIN LEVOFLOXACIN OFLOXACIN PEFLOXACIN VITEK 2 Systems Software User Manual C 5 510773 3EN1 Appendix C AES Antibiotic Deduction Rules RULE 10 INTERPRETATION GUIDELINES PHENOTYPIC Active If And And Then Enterobacteriaceae One of the following antibiotics has been tested NORFLOXACIN The result is S The result can be reported for CIPROFLOXACIN ENOXACIN GATIFLOXACIN LEVOFLOXACIN LOMEFLOXACIN MOXIFLOXACIN OFLOXACIN PEFLOXACIN RULE 221 INTERPRETATION GUIDELINES PHENOTYPIC Active If And Then Enterobacteriaceae Or Enterococcus Or Staphylococcus Or Streptococcus Or Streptococcus pneumoniae One of the following antibiotics has been tested TETRACYCLINE The result can be reported for DOXYCYCLINE RULE 241 INTERPRETATION GUIDELINES PHENOTYPIC Active If Enterococcus faecalis And One of the following antibiotics has been tested AMPICILLIN Then The result can be reported for AMOXICILLIN BENZYLPENICILLIN Cc
30. And One of the following antibiotics has been tested GATIFLOXACIN LEVOFLOXACIN MOXIFLOXACIN SPARFLOXACIN Then The result can be reported for GATIFLOXACIN LEVOFLOXACIN MOXIFLOXACIN SPARFLOXACIN RULE 41 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus pneumoniae And One of the following antibiotics has been tested BENZYLPENICILLIN And The result is S Then The result can be reported for AMOXICILLIN AMOXICILLIN CLAVULANIC ACID AMPICILLIN AMPICILLIN SULBACTAM CEFACLOR CEFDINIR CEFEPIME CEFETAMET CEFIXIME CEFOTAXIME CEFPODOXIME CEFPROZIL CEFTIBUTEN CEFTIZOXIME CEFTRIAXONE CEFUROXIME VITEK 2 Systems Software User Manual C 11 510773 3EN1 Appendix C AES Antibiotic Deduction Rules ERTAPENEM IMIPENEM LORACARBEF MEROPENEM RULE 42 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus pneumoniae And One of the following antibiotics has been tested ERYTHROMYCIN Then The result can be reported for AZITHROMYCIN CLARITHROMYCIN DIRITHROMYCIN RULE 43 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus pneumoniae And One of the following antibiotics has been tested OFLOXACIN And The result is S Then The result can be reported for LEVOFLOXACIN RULE 44 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If
31. Figure 7 13 Figure 8 1 Figure 8 2 Figure 8 3 Figure 8 4 Figure 8 5 Figure 8 6 Figure 8 7 Figure 8 8 Figure 8 9 Figure 8 10 Figure 8 11 Figure 8 12 Figure 8 13 Figure 8 14 Figure 8 15 Figure 8 16 Figure 8 17 Figure 8 18 Figure 8 19 Figure 8 20 Figure 8 21 Figure 8 22 Figure 8 23 Figure 8 24 Figure 8 25 Figure 8 26 Figure 8 27 Figure 8 28 Figure 8 29 Figure 8 30 Figure 8 31 Figure 8 32 QC Detailed Card Report ENEE 7 16 QC Cumulative Report ENEE 7 17 Enter Isolate View Icon EE 8 5 Isolate Results View EE 8 4 Navigation Tree eege ded A dod do duae 8 6 Search Accession Number ICOM nn 8 7 Search Accession Number Window ENEE 8 7 Right View Bat iiis tl lo o Be D dto d 8 9 View Patient Specimen Information Icon tette 8 14 View Specimen Information Window EEN 8 14 Additional Information Button 8 15 Additional Isolate Information Window e 8 15 Result Validation Configurations es 8 17 View ID Card Details 8 18 View AST Card Results ttes 8 19 GT E 8 22 Detailed AES Report unes 8 25 Tei 8 27 View Card Details enee dee Eelere 8 28 View Audit History Icon 8 29 View Isolate Audit ettet tette be addon 8 29 Export Isolate and Raw Instrument Data Icon 8 30 Send to SRF a aer A eb a 8 31 Laboratory Report First Page of ID Summary 8 33 Lab Report Page 2 nr 8 34 AST Card Details Report inner 8 35 ID Card Details Report nn 8 36 Send to LIS ACORN iiio t t
32. France 2000 8 Gavini F Mergaert J Beji A Mielcarek C Izard D Kersters K DeLey J Transfer of Enterobacter agglomerans Beijerinck 1888 Ewing and Fife to Pantoea gen Nov as Pantoea agglomerans comb nov and Description of Pantoea dispersa sp Nov Int J Syst Bacteriol 1989 39 337 345 9 Holt JG Krieg NR Sneath PH Staley JT Williams ST Bergey s Manual of Determinative Bacteriology 9 Edition William and Wilkins Baltimore Maryland 1994 10 Krieg NR Holt JG Bergey s Manual of Systematic Bacteriology volume 1 William amp Wilkins Baltimore Maryland 1984 1 26 VITEK 2 Systems Product Information 069041 4EN1 GN Product Information Bibliography 11 Murray PR Baron EJ Pfaller MA Tenover FC Yolken RH editors Manual of Clinical Microbiology 7 Edition American Society for Microbiology Washington D C 1999 12 Murray PR Baron EJ Jorgensen JH Pfaller MA and Yolken RH editors Manual of Clinical Microbiology Volume 1 8th Edition American Society for Microbiology Washington DC 2003 13 National Committee for Clinical Laboratory Standards M29 A Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline 1997 14 Richard C Kiredjian M Laboratory methods for the Identification of the Medically Important Glucose Nonfermenting Gram Negative Bacilli Institut Pasteur Paris France 1992
33. List of Tables xviii VITEK 2 Systems Software User Manual 510773 3ENI PART I INTRODUCTION AND GETTING STARTED VITEK 2 technology How To USE THIS MANUAL About This Chapter IMPORTANT This chapter gives you important information about the VITEK 2 Systems software and how to use this manual bioM rieux recommends that you read this chapter first Read this manual carefully before you attempt to operate the VITEK 2 Systems software Chapter Contents VITEK 2 Systems Software User Manual 1 1 510773 3EN1 Purpose of the VITEK amp 2 Systems Software 1 2 Important Software Features 1 2 Additional Supplies 1 2 Purpose of This Manual 1 3 Intended Audience 1 3 Manual Organization 1 3 How This Manual Is Organized 1 4 Chapter Organization 1 4 Finding Topics and Procedures 1 4 Finding Topics Online 1 5 Typographic and Usage Conventions 1 5 Genus and Species Names 1 5 References 1 6 Click 1 6 Commands 1 6 Names and Titles 1 6 Press 1 6 Select 1 6 User Input 1 7 Warnings Cautions and Information 1 7 System Cautions Warnings 1 8 Table of Symbols 1 10 Purpose of the VITEK 2 Systems Software How to Use This Manual Purpose of the VITEK 2 Systems Software Welcome to the System Software for VITEK 2 products the in vitro diagnostic test software used for identification ID and antimicrobial susceptibility testing AST of organisms
34. Parity Refers to an error checking Choose between None method used by computers to None determine the integrity of the Even information transmitted over a Odd communication line If the Forced to 1 receiving computer detects a Forced to 0 deviation in the parity bit then it signals the sending computer that there may be a problem with data integrity Stop bits Used by computers to indicate Choose between 1 1 5 1 the end of each character as it is and 2 transmitted over a communication line This allows the receiving computer to recognize the end of each character VITEK 2 Systems Software User Manual 12 19 510773 3EN1 Configure and Maintain BCI Tools Table 12 1 Configuration Parameters Parameters Description Possible Values Default HW Flow Hardware handshaking define as None None required and the same as the DTR DSR cable RTS CTS Full Tools Before opening or printing a file you must save it 1 Select Save Configuration 2 Choose a file name and determine its location on your computer Note To access the Open Configuration and Save Configuration options in the Tools menu you must log in as a supervisor If you log in as a laboratory technologist you will only be able to print the configuration 3 Double click Tools 4 The Tools submenu is displayed Open Configuration Enables you to load connection parameters Save Configuration Enables you to save connection parame
35. Printing QC Laboratory Reports 7 14 QC Laboratory Report 7 15 QC Detailed Card Report 7 16 QC Cumulative Report 7 17 Part Ill View and Maintain Results VIISCHT CH 8 1 Access the Isolate Results View 8 3 Using the Navigation Tree to View Specific Isolate Results 8 4 Active Workspace versus Inactive Workspace 8 5 Expanding and Collapsing the Navigation Tree 8 6 Search by Accession Number 8 7 Status Icons and Descriptions 8 7 Qualified Isolates 8 9 Using the Right View Bar to View Specific Results 8 9 Modifying Isolate Groups and Test Cards 8 11 Changing the Laboratory Identification Number 8 12 Changing the Isolate Number 8 12 Changing the Organism Name 8 13 Viewing or Updating Patient Specimen Information 8 13 Changing Additional Information and Organism Ouantity 8 15 Confirm Changes to the Isolate Group 8 17 ID Card Details age ck DR Ee
36. VITEK 2 Compact instrument 1 15 VITEK 2 instrument Qc Sets the card up as a Quality Control card For details see Setting Up and Entering Quality Control QC Information on page 4 24 Not checked Card Type Displays the card using the abbreviated card type name Card type of card scanned Bar Code Displays the last four digits of the card bar code Bar code of card scanned Accession The Laboratory Identification number plus the Isolate Number For details see Defining Isolate Group Information on page 4 10 Blank Organism The organism name from a drop down list for AST cards Blank Offline Tests The Offline test can be selected from a drop down list for AST Cards when the Offline test is required Blank Message Displays the status message for the card If the card is loaded and scanned with the appropriate information the value that appears in this column will be Loaded Loaded Defining the Selected Cassette Set Up Test Cards and Cassette Information Table 4 2 Card Definition Columns Er Description Default Value Org Qty The organism quantity This is a free Blank text field used to record the amount of organism found on the primary isolation plate For example 3 Heavy Defining Isolate Group Information Note To associate test cards you can create isolate groups An isolate group consists of one o
37. VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules IMIPENEM PIPERACILLIN RULE 21 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested MEZLOCILLIN PIPERACILLIN Then The result can be reported for MEZLOCILLIN PIPERACILLIN RULE 22 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested AMOXICILLIN CLAVULANIC ACID AMPICILLIN SULBACTAM Then The result can be reported for AMOXICILLIN CLAVULANIC ACID AMPICILLIN SULBACTAM RULE 23 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested CEFAMANDOLE CEFONICID CEFUROXIME Then The result can be reported for CEFAMANDOLE CEFONICID CEFUROXIME VITEK 2 Systems Software User Manual C5 510773 3EN1 Appendix C AES Antibiotic Deduction Rules RULE 24 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested CEFOTAXIME CEFTIZOXIME CEFTRIAXONE Then The result can be reported for CEFOTAXIME CEFTIZOXIME CEFTRIAXONE RULE 25 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2
38. cohnii Staphylococcus cohnii ssp urealyticus formerly known as Staphylococcus cohnii ssp urealyticum Staphylococcus epidermidis 2 14 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information Organisms Identified by the GP Card Staphylococcus equorum Staphylococcus gallinarum Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus hyicus Staphylococcus intermedius Staphylococcus kloosii Staphylococcus lentus Staphylococcus lugdunensis Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus vitulinus Staphylococcus warneri Staphylococcus xylosus Streptococcus agalactiae Streptococcus alactolyticus Streptococcus anginosus Streptococcus canis Streptococcus constellatus ssp constellatus Streptococcus constellatus ssp pharyngis Streptococcus cristatus Streptococcus downei Streptococcus dysgalactiae ssp dysgalactiae Streptococcus dysgalactiae ssp equisimilis Streptococcus equi ssp equi Streptococcus equi ssp zooepidemicus Streptococcus equinus Streptococcus gallolyticus ssp gallolyticus Streptococcus gallolyticus ssp pasteurianus Streptococcus gordonii Streptococcus hyointestinalis Streptococcus infantarius ssp infantarius Streptococcus infantarius ssp coli Streptococcus bovis Streptococcus intermedius Streptococcus mitis Str
39. it is still possible for the reaction pattern to be sufficiently close to that of an expected reaction pattern such that a clear decision can be provided about the organism identification The range of percent probabilities in the one choice case is 85 to 99 Values closer to 99 indicate a closer match to the typical pattern for the given organism 5 6 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information Additional Information on the Lab Report When the reaction pattern is not sufficient to discriminate between two to three organisms the percent probabilities reflect this ambiguity The reported probability values indicate relatively the order in which the reaction pattern best corresponds to the listed possibilities The order does not however suggest that the pattern match to one of the possible identifications is clearly superior to another The probability characteristic of an overall sum of 100 is retained through the calculation process After resolution to one choice the probability characteristic of the single choice is retained Additional Information on the Lab Report Supplemental test External test that allows the user to resolve a slashline or Low Discrimination identification Contraindicating test Test result that is unusual for a reported taxon Notes associated with certain taxa Table 5 4 Notes associated with certain taxa Note Taxa Possibility of Aneurinibacillus
40. patient record 5 4 unique ID 5 3 view all specimens 5 3 by hospital number 5 2 by patient last name 5 2 only specimens with isolates 5 3 only specimens without isolates 5 3 Preview Report Window 5 8 Print Cassette Report Dialog 4 5 Print Isolate Audit Report 7 7 Print Isolate Result Reports 8 30 Print QC Lab Report 7 7 Print Settings global automatically print lab report after analysis 10 8 prompt for lab report after qualified validated 10 8 Print SRF Report 6 5 Print User Change Report 11 22 QC add modify QC comments 7 5 QC isolate groups 4 25 quality control card 4 9 record lot shipments 2 5 review and approve quality control results 2 5 test for new card shipments 4 24 QC Cumulative Report 7 18 QC ID Card Details Report 7 17 QC Isolates background information 7 2 QC Laboratory Report 7 16 QC Reference ID change 7 6 QC Reports QC cumulative report 7 18 QC ID Card Details report 7 17 QC laboratory report 7 16 QC Results apply electronic signature 7 8 approve 7 9 card details 7 7 create custom filter 7 4 enable batch selection 7 2 electronic signatures 7 2 filter by current all isolates 7 5 current deviation only 7 5 current to be approved 7 5 current to be reviewed 7 3 custom 7 5 final not qualified complete 7 5 final qualified 7 5 preliminary 7 2 review 7 8 to be approved 7 5 to be reviewed 7 3 to be reviewed icon 7 8 validation configuration 7 8 7 12 view by Card Type 7 5 date
41. tel 64 9 415 0601 fax 64 9 415 0603 Norway bioM rieux Norge AS kernveien 145 N 0513 Oslo tel 47 23 37 55 50 fax 47 23 37 55 51 Philippines The Representation Office bioM rieux Phillipines Rep Office 11th Floor Pearlbank Centre 146 Valero Street Salcedo Village 1227 Makati City tel 632 817 7741 fax 632 812 0896 Poland bioM rieux Polska Sp Z o o ul Zeromskiego 17 01 882 Warszawa tel 48 22 569 85 00 fax 48 22 569 85 54 Portugal bioM rieux Portugal Lda Rua Alto do Montijo Lotes 1 e 2 Portela de Carnaxide 2794 070 Carnaxide tel 351 21 424 59 80 fax 351 21 418 32 67 Russia 0 0 0 bioM rieux Petrovsko Razoumovskii proyezd 29 127287 Moscow tel 7 095 212 10 26 7 095 424 79 38 fax 7 095 214 95 41 Spain bioM rieux Espaiia S A Manual Tovar 45 47 28034 Madrid tel 34 91 358 11 42 fax 34 91 358 06 29 Distribution in over 130 countries Sweden bioM rieux Sverige AB Hantverksv gen 15 436 33 Askim tel 46 31 68 84 90 fax 46 31 68 48 48 Switzerland bioM rieux Suisse s a 51 avenue Blanc Case postale 2150 1211 Gen ve 2 tel 41 22 906 57 60 fax 41 22 906 57 42 Taiwan Representation Office bioM rieux China Limited Ta wan Branch RM 608 No 6 3 Ching Cheng Street Taipei 105 tel 886 2 2545 2250 fax 886 2 2545 0959 Thailand bioM rieux Thailand Ltd Regent House Bldg 16th Floor 183 Rajdamri Road Lu
42. validated for acceptable performance by the customer laboratory The card performs as intended only when used in conjunction with VITEK 2 systems Use clear plastic polystyrene test tubes only Do not use glass test tubes Variation exists among test tubes of standard diameter Carefully place the tube into the cassette If resistance is encountered discard and try another tube that does not require pressure to insert Give special consideration to specimen source and patient drug or antimicrobic regimen There are antimicrobials included in AST cards that are not proven to be effective for treating infections for all organisms that may be tested For interpreting and reporting results of antimicrobials shown to be active against organism groups both in vitro and in clinical infections refer to the individual pharmaceutical antibiotic labeling or the most recent CLSI M100 Performance Standard Table 1 Suggested groupings of U S FDA approved antimicrobial agents that should be considered for routine testing and 6 4 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Storage and Handling reporting by clinical laboratories and Table 2 MIC Interpretive Standards Interpretation of test results requires the judgment and skill of a person knowledgeable in antimicrobial susceptibility testing Additional testing may be required 4 WARNING infectious and should be treated with uni
43. 11 is enabled the Setup Tech field is blank 6 If Bench Name is enabled in the configuration select a Bench Name from the list benches where the cassette will be introduced 7 Enter a bar code for each available slot either by using the bar code scanner or by entering the bar codes manually from the workstation keyboard 8 Enter the Lab ID 9 Enter any offline test information 10 Enter the Organism Quantity 11 Link ID and AST cards to create isolate groups Refer to Defining Isolate Group Information on page 4 10 for details Enter the Organism ID here if desired 12 Click Save to save the new virtual cassette to the system software 1 ss 4 18 VITEK 2 Systems Software User Manual 510773 3EN1 Set Up Test Cards and Cassette Information Using the Virtual Cassette Workflow 13 When the instrument processes the cards by reading the bar codes on the cards the system matches the information with the data that you entered 14 When the system confirms a match the instrument processes the test cards 15 If there is not a consistent match between the Virtual Cassette and the Actual Cassette review the Reconciliation Details Viewing Reconciliation Details Reconciliation consists of comparing the Virtual Cassette definition to the Actual Cassette definition loaded into the instrument Any reconciliation problems detected by the Instrument are reported and you can view the reconciliation details on the system software
44. 2 Inactive Workspace aged isolate reports removed 14 6 aged QC isolates removed from 14 6 Inactivity Time Limit unsaved data 2 10 Inactivity Timer AES configuration 11 4 customize 2 10 10 7 initializes when application starts up 2 7 Incorrect Lab ID 5 5 Industry Mode enable SRF analysis 9 3 maintain SRF data 2 5 Instrument alarm message history 3 7 instrument messages 3 6 parameters Glossary 4 raw data Glossary 4 VITEK 2 Compact Glossary 4 Instrument Reports alarm history report 3 7 BCI alarm history report 12 25 current BCI alarm report 12 24 Instrument Status current 3 3 icon 3 2 monthly 3 5 Interface Connections BIS 12 12 link history 12 12 OOS 12 12 reception of assays download 12 11 VITEK 2 Systems Software User Manual 510773 3EN1 Index 5 Index start stop 12 10 status 12 5 transmission of results upload 12 11 unused connection 12 6 view real time interface connection 12 13 Isolate Audit Report export 8 28 print 8 28 view 7 6 Isolate Data backup CD 14 7 lab tech initiated 14 3 manual 14 2 Isolate Group AES detailed reports 8 22 card class 8 26 change additional information organism quantity 8 14 confirm changes to information 8 16 isolate number 8 12 laboratory identification number 8 11 new version of lab report 8 11 organism short name 8 12 patient specimen information 8 13 to a card 8 10 to an isolate group 8 10 definition 4 10 link test cards 4 9 4 10 move te
45. 2 Systems Product Information 069043 4EN1 YST Product Information YST Quality Control Table Table 3 11 QC Organism Prototheca wickerhamii ATCC 16529 LysA ARBa GGT IRHAa NO3a CITa IMLTa AMYa dMALa v XLTa V IARAa GRTas V LeuA dGAa v dRAFa dsORa dGATa v IPROa V ARG v GENA NAGAI SACa ESC 2KGa v ERYa dGLUa dMNEa v URE V IGLTA v NAGa v GLYLa v LACa dMELa AGLU dXYLa v dGNTa v TyrA MAdGa dMLza dTURa LATa v BNAG dCELa ISBEa dTREa ACEa v 4 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 3 12 Recommended QC Organism Trichosporon mucoides ATCC 204094 LysA v ARBa V GGT IRHAa NO3a v CITa V IMLTa v AMYa dMALa XLTa IARAa GRTas LeuA dGALa dRAFa dSORa v dGATa IPROa v ARG GENa v NAGAI v SACa v ESC v 2KGa ERYa dGLUa dMNEa v URE IGLTA v NAGa V GLYLa LACa dMELa AGLU dXYLa dGNTa TyrA v MAdGa dMLza v dTURa v LATa ap BNAG dCELa V ISBEa v dTREa V ACEa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive 069043 4EN1 Limitations YST Product Information Limitations The VITEK 2 YST card cannot be used with direct clinical samples or other sources containing mixed flora Any change or modification in the procedure may affect the results Newly described or rare species may not be includ
46. 2 Systems Software User Manual 510773 3ENI Maintain Supplemental React File Industrial Use Linking Associating Biopatterns with SRF Organisms 4 Aconfirmation window appears asking you to confirm the deletion of the unassociated SRF biopattern Click Yes to confirm 5 The unassociated SRF biopattern is removed from the SRF database Linking Associating Biopatterns with SRF Organisms An unlimited number of SRF biopatterns can be associated with SRF organisms Once the SRF organism has 10 SRF biopatterns associated with it the SRF organism is eligible for activation For details on activating SRF Organisms see Activating SRF Organisms on page 6 14 Note SRF biopatterns can be left unassociated Associating a Biopattern to an Existing Organism To associate SRF biopattern to an existing SRF organism 1 Select the SRF organism in the displayed list and click Maintain SRF Organism Association Figure 6 10 Maintain SRF Organism Association Icon VITEK 2 Systems Software User Manual 510773 3EN1 Linking Associating Biopatterns with SRF Organisms Maintain Supplemental React File Industrial Use 2 The Maintain SRF Association view appears NU tini sin SRF Association xl SRF Organism and Diopattern Association SRE Organism and Bopatterns Fee Sort an Oromim Status fee Accession 8 J Bionumber Original Organism Si VITEK 2 technology Figure 6 11 Maintain SRF Association View 3 Select the SRF
47. 2202049ju0 10 2u3 22020KudDIs 104 udpjs se pojeu isop ase sdnoj8 wusiue810 5ijreds zua Au iqionpoadai o1de 3 nso1 adUdJaJaJ juejsiso1 JO o qnde sns e YUM Us 93elpauueur ue JO j nsaJ 92U919J91 9jerpeuuejul UP QM 3 nsa1 juejsiseJ JO e qndeosns 10119 JOUILW FW 1 nsol 92ua19jaJ e qnde sns uim 3 nsa1 juejsisaJ 10119 JOfew JW 3 nsa1 sou JajaJ 1UejsIsaJ uM 3 nsa1 e qndeosns 10118 Jofew Aan JWA 1ueureai8e 1089329 y juouio918e Jenuesse YJ aIZOjOIqOIDI ep esieSued 9491205 e op euiuei8orqnuy 9p JPW DIEN emnsu spyepuejs AJOJEJOGET pue eu IST eemiuuuroo juiodyeaiq 1dyg suonemeiqqv unAwodUueA eJozexoujeuiejins 16 ZLXS 1 ISD uudousuu LIXS udejs 3 WAS v5 LIXS ydeys 3 IS LLXS snaine e e ozexotgeuiej ns IE IS 1XS uudoyuu eweN uoumuo Jeiqonmunuy 1SV 9Anisod WELID JOJ sonsuoepeiey e ueuuoped 1SV 9 nisod WELID JOJ sonsuoepeieu e ueuuoped 2UtDade jerqoirumuy Z MILIA 9 9 qer VITEK 2 Systems Product Information 6 26 510774 3EN1 Performance Characteristics Susceptibility Product Information 6 27 pnis eoueuuoped Eau 10 POUJOW BdUdIEJOY JIH uesui oBey9ed ui podualaja si epoo ejeudouddy SonsuejoeJeuo eoueuuoped loads seynuoepi YOIUM epoo 1ueuluio2 ZLXS JO LLXS e qeordde JON Y N OIQEIIBAE JON VITEK 2 Systems Product Information 510774 3EN1 Susceptibility Product Information Performance Characteristics oiday
48. 4 ID card ejection time 9 5 status message 4 9 type 4 9 view biochemical results 8 17 card details 8 9 Card Definition Table 4 9 Card Details 7 7 AST cards 7 7 8 54 ID cards 7 7 8 55 Cards record shipment of new cards 7 12 Cassette actual cassette 4 16 bar codes for virtual cassette 4 18 card number in 4 9 cards defined 4 7 create a virtual cassette 4 16 incomplete cassette 4 5 information for cards in each slot 4 8 instrument where cassette was loaded 4 6 load time 4 6 modify cassette information 4 14 needs info status 4 5 print preview cassette information 4 12 save information entered 4 11 tests begin processing data 4 12 view loaded cassette status 4 5 virtual cassette 4 16 Cassette Report print cassette information 4 12 4 13 Cassette Worksheet See Blank Cassette Worksheet Cassette Specific Information in active workspace 4 5 VITEK 2 Systems Software User Manual 510773 3EN1 Index 3 Index Cautions use in manual 1 7 Change QC Reference ID 7 6 Change Setup Tech Name 7 6 Change User while Application Is Running 2 10 Chapters organization 1 4 Chart Report 8 30 Clinical Mode set system mode 10 7 Configuration 10 2 AES configuration 8 21 11 2 AST configuration 9 5 BCI configuration 8 35 12 25 for reviewing and approving results 8 39 general configuration 9 2 10 4 ID configuration 9 3 result validation 7 9 8 39 9 6 software version installed 10 10 Configuration Settings l
49. 510773 3EN1 Glossary 1 Glossary Bar Code 1 A CODE37 interface identifier label affixed to each VITEK 2 test card The bar code contains the card s test type lot number and expiration date The bar code is entered into the system when the Bar Code Reader scans the test card s bar code label In VITEK 2 bar codes can also be entered by the Smart Carrier Station 2 An alphanumeric identifier for the configuration of the susceptibility panel located on the package insert The bar code is entered into the Maintain AST Card Definitions prior to running the susceptibility card Bar Code Reader A station in the VITEK 2 instruments that reads the Bar Code label on each test card As cards are read the associated data along with its corresponding bar code is transferred to the workstation Bench Name An alphanumeric name that tags a bench where a given cassette was set up The VITEK 2 Systems software supports an alphanumeric value of up to any 20 valid characters Biochemical A substrate on an identification card also known as a biochemical test or biochemical formulation Biochemical Reaction The result from an Identification Card Well as determined by analysis parameters Also known as Biochemical Result Biological Validation The process of determining whether observed Susceptibility results for an organism are consistent with the antibiotic s susceptibility patterns phenotype in the AES knowledgebase Bionumber Number
50. 8 VITEK 2 Systems Software User Manual 510773 3ENI View and Configure AES Creating Custom Parameter Sets 3 When this occurs a confirmation message displays Confirm the activation of parameter set Copy of NCCLS Natural Resistance This parameter set will be used for future expert validation VITEK 2 technology Figure 11 6 Activate Parameter Set Confirmation Message 4 Click Yes if you want to activate the selected parameter set Note Activating one parameter set automatically deactivates the previous active parameter set Creating Custom Parameter Sets AES Configuration allows supervisors to customize the AES Expertise component of the system software The laboratory technologist can only view the AES configuration settings The Supervisor can view create modify or delete configurations but a supervisor cannot alter the pre defined parameter sets Note Predefined parameter sets can never be modified or deleted VITEK 2 Systems Software User Manual 510773 3EN1 Creating Custom Parameter Sets View and Configure AES Creating a Custom Parameter Set To create a new custom parameter set based on a predefined parameter set follow these steps 1 Select the base parameter set 2 Click Create New Component Figure 11 7 Create New Component Icon 3 Enter a unique name and description to the new parameter set Note A parameter set name has to be unique in the knowledge base A mess
51. AES knowledge base VITEK 2 Systems Software User Manual 8 23 510773 3EN1 Viewing Detailed AES Report Clinical Use View and Maintain Isolate Results TABLE 8 7 AES CONFIDENCE LEVELS Icon Confidence Level Description Expert Analysis Not Phenotypes cannot be detected Performed Phenotypes for the detected organism Purple are not described in the AES knowledge base Viewing Detailed AES Report Clinical Use The Detailed AES report provides you with detailed information related to AES findings All recognized phenotypes for the selected isolate are printed in this report Note The AES detailed report only includes the Recognized and Best phenotypic matches 1 From within the View and Maintain Isolate Results view select an isolate group with an AST card 2 Click View Detailed AES Report 3 The Detailed AES Report is arranged in four sections Phenotypes Therapeutic Interpretations MIC Differences and Antibiotic Deductions Phenotypes Antibiotic Family Lists each tested antibiotic family Detected Phenotypes Lists one or more phenotypes proposed by AES for each antibiotic family Therapeutic Interpretations Antibiotic Lists antibiotics with Therapeutic Changes Interpretation Changes Defines the change Reason rule or phenotype Reasons may include an MIC change a Forced Resistant Rule or the detection of a resistant phenotype When more th
52. Ability to use melibiose as 2 3 5 Assimilation the sole carbon source OX_Phe Phenol Oxidase Ability to produce brown to 7 black pigment from phenol oxidase activity on phenolic substrates e g caffeic acid or birdseed agar dRAFFIN a D RAFFINOSE Ability to use raffinose as 2 3 5 Assimilation the sole carbon source IRHAMNOSEa L RHAMNOSE Ability to use rhamnose as 2 3 5 Assimilation the sole carbon source SACCHAR a SACCHAROSE Ability to use sucrose as the 2 3 5 SUCROSE Assimilation sole carbon source SACf SACCAROSE Production of gas from 2 3 5 SUCROSE fermentation of sucrose Fermentation SATELLITE SATELLITE behavior Formation of satellite 2 3 5 colonies on Sabouraud Dextrose agar VITEK 2 Systems Product Information 3 19 069043 4EN1 YST Supplemental Tests YST Product Information Table 3 14 YST Supplemental Tests Abbreviation Test Name Description Comments Reference Sphe CELLS Spherical CELLS Microscopic examination Candida famata can 2 3 5 for the presence of be differentiated spherical cells from Candida guilliermondii by the shape of the cells Candida famata has mostly spherical cells while Candida guilliermondii has mostly ovoid cells SPORANGE SPORANGE Microscopic examination 6 for the presence of sporangia dTREHAL a D TREHALOSE Ability to use trehalose as 2 3 5 Assimilation the sole carbon source dTREf D TREHALOSE Production of gas from 2 5 5 Fermentation fermentation o
53. Antibiotic Expected Amikacin 00 Ciprofloxacin Ampicilin 00 Gentamicin lampicillin Sulbactam s20 3 32 Imipenem Aetreonam 00 Levofloxacin Cefazolin 00 Nitrofurantoin Cefepime 00 Fiperacilin Cefotetan 00 Piperacilin Tazobactam Ceftazidime 0 0 Ticarcillin Clavulanic Acid Ceftriaxone 0 0 Tobramycin Cefuroxime 0 0 Trimethoprim Sulfamethoxazole BPagetof1 M85xttin Lal Figure 7 11 QC Laboratory Report VITEK 2 Systems Software User Manual 7 15 510773 3EN1 Printing QC Laboratory Reports Maintain Customer Quality Control QC Detailed Card Report The QC Detailed Card report prints details about the QC card processing Wac card Detail GMC Build 195 PRD Test Protocols QC ID Card Details Report Printed Apr 7 2004 10 56 QC Reference ID Card Type Card Lot Number Card Expiration Date Card Bar Code Instrument Serial Number Date Time of Initial Read Date Time Cassette Crested var 10 2001 16 50 D Page 1 of 1 28 5 11 0in Figure 7 12 QC Detailed Card Report 7 16 VITEK 2 Systems Software User Manual 510773 3EN1 Maintain Customer Quality Control Printing QC Laboratory Reports QC Cumulative Report This report consolidates QC results and sorts them by testing date and lot number into a single cumulative report This allows you to easily compare the test results for one or more card lot numbers
54. BAlap dTAG NAGA BGUR PyrA ce ProA v dTRE AGAL v Joao JARL Joer Lu v jar PHOS v cca dcEL leau PLE MN laya v wm BGAL Iowa tyA v Ja ODC JEM H2S dman URE v an v EDC JILATA BNAG dMNE dSOR Jacu IHISa 95 to 100 positive v 6 to 94 positive 0 to 5 positive VITEK 2 Systems Product Information 1 11 069041 4EN1 GN Quality Control Table GN Product Information Table 1 7 Recommended QC Organism Klebsiella oxytoca ATCC 700324 APPA AGLTp 2x BXYL SAC SUCT v CMT ADO dGLU BAlap dTAG NAGA BGUR PyrA v GGT ProA dTRE AGAL GP O129R IARL OFF LIP CIT v PHOS Hi GGAA dCEL BGLU PLE MNT v GIyA IMLTa BGAL dMAL TyrA v 5KG opc ELLM H2S dMAN URE ILATk v LDC dp ILATa BNAG dMNE dSOR v AGLU IHISa 95 to 100 positive v 6 to 94 positive 0 to 5 positive Occasional negative reaction may occur with faster identification result Table 1 8 QC Organism Ochrobactrum anthropi ATCC BAA 749 APPA v AGLTp V BXYL SAC V SUCT v CMT ADO v dGLU V BAlap v dTAG V NAGA BGUR PyrA GGT v ProA E dTRE V AGAL O129R IARL OFF LIP v CIT V PHOS GGAA dCEL v BGLU V PLE v MNT GlyA IMLTa BGAL dMAL V TyrA ar 5KG ODC ELL
55. CFR 11 is enabled any change made to an isolate group creates a new version of the isolate lab report and indicates a change has been made after final call 2 Select the isolate number and make any necessary changes 3 The system software displays a confirmation window 4 The system software updates the isolate number for the card or all cards in the selected isolate group 8 12 VITEK 2 Systems Software User Manual 510773 3ENI View and Maintain Isolate Results Modifying Isolate Groups and Test Cards Note Ifthe isolate is complete shown by a green status icon the user must enter a change comment Changing the Organism Name An Isolate with an AST card can only be changed at the isolate level AST Card Isolate level changes only An Isolate with only an ID card can be changed at either the Isolate level or the card level ID Card Isolate level changes Card level changes To modify information associated with isolate results 1 Select an isolate group or an individual test card Note lf21 CFR 11 is enabled any change made to an isolate group creates a new version of the isolate lab report and indicates a change has been made after final call 2 Select the Organism Name and make any necessary changes If the result is low discrimination or slashline the candidate Organism Names appear in the drop down list If the identification results in low discrimination and you change the Organism Name the norm
56. Character Set from the drop down list if the system software and the external data management system communicate using a different character set Character sets include ISO 8859 1 Default VIF 8 Shift JIS 12 26 VITEK 2 Systems Software User Manual 510773 3EN1 BCI Configuration Settings BCI Upload Tab Configure and Maintain BCI This tab allows you to set up and define information regarding which fields you want to send to the LIS for the selected connection TABLE 12 2 BCI UPLOAD TAB SETTINGS BCI Configuration aum Default Description Setting Value Automatic Transfer Transfer results as soon as they are Disabled complete and final Send Deduced Drugs If enabled deduced drugs are Enabled included in the BCI packet Field Length The character length for the fields Variable sent to the LIS Case of Data Sent data is in upper or lower case As Is format Date Format The format in which the date is sent mm dd yyyy to the LIS Miscellaneous Tests to Special tests that do not have typical Enabled Upload MIC Interpretation results Use Fixed Lab ID Width Use a predetermined width for the Disabled Lab ID field Minimum Lab ID Width The minimum width allowed for the Disabled Lab ID field Fields to Upload The fields to be sent to the LIS All Selected VITEK 2 Systems Software User Manual 12 27 510773 3EN1 Configure and Maintain BCI BCI Configuration Setti
57. Contents BCL Product Information BCL Well Contents Table 5 15 BCL Well Contents Well Test Mnemonic Amount Well 1 BETA XYLOSIDASE BXYL 0 0324 mg 3 L Lysine ARYLAMIDASE LysA 0 0228 mg 4 L Aspartate ARYLAMIDASE AspA 0 024 mg 5 Leucine ARYLAMIDASE LeuA 0 0234 mg 7 Phenylalanine ARYLAMIDASE PheA 0 0264 mg 8 L Proline ARYLAMIDASE ProA 0 0234 mg 9 BETA GALACTOSIDASE BGAL 0 036 mg 10 L Pyrrolydonyl ARYLAMIDASE PyrA 0 018 mg 11 ALPHA GALACTOSIDASE AGAL 0 036 mg 12 Alanine ARYLAMIDASE AlaA 0 0222 mg 13 Tyrosine ARYLAMIDASE TyrA 0 0282 mg 14 BETA N ACETYL GLUCOSAMINIDASE BNAG 0 0408 mg 15 Ala Phe Pro ARYLAMIDASE APPA 0 0384 mg 18 CYCLODEXTRINE CDEX 0 3 mg 19 D GALACTOSE dGAL 0 3 mg 21 GLYCOGENE GLYG 0 1875 mg 22 myo INOSITOL INO 0 3 mg 24 METHYL A D GLUCOPYRANOSIDE acidification MdG 0 3 mg 25 ELLMAN ELLM 0 03 mg 26 METHYL D XYLOSIDE MdX 0 5 mg 27 ALPHA MANNOSIDASE AMAN 0 056 mg 29 MALTOTRIOSE MTE 0 5 mg 30 Glycine ARYLAMIDASE GlyA 0 012 mg 31 D MANNITOL dMAN 0 5 mg 32 D MANNOSE dMNE 0 5 mg 34 D MELEZITOSE dMLZ 0 5 mg 36 N ACETYL D GLUCOSAMINE NAG 0 3 mg 37 PALATINOSE PLE 0 3 mg 39 L RHAMNOSE IRHA 0 3 mg 41 BETA GLUCOSIDASE BGLU 0 036 mg 43 BETA MANNOSIDASE BMAN 0 036 mg 44 PHOSPHORYL CHOLINE PHC 0 0366 mg 45 PYRUVATE PVATE 0 15 mg 46 ALPHA GLUCOSIDASE AGLU 0 036 mg 5 16 VITEK 2 Syst
58. Control Table and should be processed according to the procedure for test isolates outlined in this document The GN card will identify the quality control organisms as one choice or within a low discrimination or slashline identification See the GN Quality Control Tables for more details Frequency of Testing VITEK 2 Systems Product Information 1 9 069041 4EN1 Currently it is recommended that you use your most stringent inspecting agency s guidelines for frequency of identification product testing Common practice is to perform QC upon receipt of shipment of the test kits Reactions must follow Product Information results If the results do not meet the criteria subculture for purity and repeat test If discrepant results are repeated perform an alternate identification method Quality Control GN Product Information Testing and Storage of QC Organisms Rehydrate organism according to the manufacturer s instructions Use Trypticase Soy agar with 5 sheep blood TSAB Incubate aerobically at 35 C to 37 C for 18 to 24 hours Check for purity Perform second subculture for testing Storage Conditions Short Term Storage 1 Streak to a TSAB plate or slant 2 Incubate for 24 hours at 35 C to 37 C 3 Refrigerate at 2 C to 8 C for up to two weeks 4 Subculture once as described above and use for QC Long Term Storage 1 Make a heavy suspension in Tryptic Soy Broth TSB with 15 glycerol 2 Freez
59. Enterococcus And One of the following antibiotics has been tested AMPICILLIN Then The result can be reported for AMOXICILLIN PIPERACILLIN RULE 284 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterococcus And One of the following antibiotics has been tested AMPICILLIN BENZYLPENICILLIN And The result is S VITEK 2 Systems Software User Manu C 17 510773 3EN1 Appendix C AES Antibiotic Deduction Rules Then The result can be reported for AMOXICILLIN CLAVULANIC ACID AMPICILLIN SULBACTAM PIPERACILLIN TAZOBACTAM RULE 585 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested GATIFLOXACIN MOXIFLOXACIN Then The result can be reported for GATIFLOXACIN MOXIFLOXACIN RULE 584 INTERPRETATION GUIDELINES PHENOTYPIC Active If Staphylococcus Or Streptococcus pneumoniae And One of the following antibiotics has been tested LINCOMYCIN Then The result can be reported for CLINDAMYCIN C18 VITEK 2 Systems Software User Manual 510773 3ENI GLOSSARY Accession ID number Advanced Expert System AES Antibiotic Antimicrobial Antimicrobial Susceptibility Testing Application Archive data AST AST card AST Card Definitions Backup The Accession ID number is a unique alphanumeric number that identifies a card to the system The Accession ID number
60. FORCING RULES B Introduction This Appendix contains the following configuration information for AES CLSI Forcing Rules Global Forcing Rules CA SFM Forcing Rules CLSI Forcing Rules IMPORTANT CLSI Forcing rules will force the category call only not the MIC Rule 1 If the cefoxitin screen test OXSF is positive and oxacillin OX1 is susceptible the oxacillin MIC interpretation is forced resistant For speciated CNS other than Staphylococcus epidermidis and Staphylococcus lugdunensis if the cefoxitin screen test OXSF is negative and the oxacillin OXT MIC is 0 5 1 or 2 the oxacillin MIC interpretation is forced susceptible A note is included when a KeyID of coagulase negative staphylococci is used i e not speciated indicating that inappropriate oxacillin breakpoints may be applied Note Final oxacillin interpretation after AES expertization is also dependent on the recognized B Lactam phenotype If the test oxacillin OX1 is resistant for the Staphylococcus species then the results are automatically forced resistant for the following antibiotics Penicillins Amoxicillin Amoxicillin Clavulanic Acid Ampicillin Sulbactam Ampicillin Azlocillin Benzylpenicillin VITEK 2 Systems Software User Manual B 1 510773 3EN1 Appendix B Forcing Rules Carbenicillin Cloxacillin Dicloxacillin Methicillin Mezlocillin Nafcillin Oxacillin Piperacillin Piperacillin Tazobactam Ticar
61. Failure 14 9 VITEK 2 Systems Software User Manual 14 1 510773 3EN1 Backup Isolate Data Data Backup and Daily Maintenance Backup Isolate Data Nightly backups of the database can be performed automatically and unattended Note Itis recommended that you use read write media for example CD RW for performing an unattended backup of isolate data There are two methods for initiating backup laboratory technologist initiated backup or automatic backup The database includes isolate information in the active workspace information in the inactive workspace and user custom setting System or automatic backup is enabled in the General Configuration view For details see Chapter 10 Enabling Automatic Daily Backup Note Be sure to change CDs daily CD RWs can be overwritten Recommended Backup Strategy It is very important to create a backup CD on a regular basis The following instructions provide a recommended strategy to ensure all of your data is saved appropriately Daily Use one CD RW for each day of the week that the system is actively used Substitute a new CD RW at the end of each day to ensure that your data is properly saved on a regular basis Weekly Once a week replace one of the used CD RWs with a new one Permanently store the used CD RW in a secure climate controlled location as a weekly backup Note Make sure you replace the oldest CD RWs first in order to keep the CD RW media current Long Term
62. Maintain Inactive Workspace Cumulative Patient Isolate and Audit Management Isolate Reports The system software maintains isolate reports in the inactive workspace by removing aged isolate reports The system software applies the following criteria to remove isolates e If 21 CFR11 isolates must be flagged as Archived If patient information is enabled in configuration the oldest isolate reports are flagged to be removed from the inactive workspace if there are more than 20 000 isolate reports in the inactive workspace 14 6 VITEK 2 Systems Software User Manual 510773 3ENI Data Backup and Daily Maintenance Restore Isolate Data Supervisor Only If an isolate report is determined to be aged from the inactive workspace the isolate and all related components are deleted Cumulative QC Isolate and Audit Management Isolate Reports The system software maintains QC isolates in the inactive workspace by removing aged QC isolates The system software applies the following criteria to remove QC isolates If 21 CFR11 is enabled isolates must be flagged as Archived If there are more than 15 000 QC isolates in the active workspace then the oldest QC isolates are flagged to be removed from the inactive workspace to keep the number of QC isolates near 15 000 If the QC isolate is determined to be aged from the inactive workspace then the QC isolate is deleted Deleted Isolates in the Inactive Workspace The system softwa
63. McFarland Standard N A lt 30 minutes GN and AST GN pair CBA MAC TSAB 18 to 24 hours 35 C to 37 C Aerobic non CO 0 50 to 0 63 McFarland Standard 145 pL in 3 0 mL saline 30 minutes These media were used in the identification product database development and will give optimal performance 1 2 VITEK 2 Systems Product Information 069041 4EN1 GN Product Information Culture Requirements Table Culture Requirements Table Media Abbreviations BCP Brom Cresol Purple agar CBA Columbia agar with 5 sheep blood CET Cetrimide agar CHBA Columbia horse blood agar CHOC Chocolate agar CHOC PVX Chocolate Polyvitex CLED Cystine Lactose Electrolyte Deficient agar CNT CountTACT CPS ID3 CPS ID3 DENA DE Neutralizing agar DRIG Drigalski agar HEK Hektoen agar MAC MacConkey agar TSA Trypticase soy agar TSAB Trypticase soy agar with 5 sheep blood TSAHB Trypticase soy agar with 596 horse blood TSAL TSA with Lecithin and P80 VRBG Violet Red Bile Glucose agar XLD Xylose Lysine Desoxycholate VITEK 2 Systems Product Information 4 25 069041 4EN1 Bibliography GN Product Information Bibliography 1 American Society for Microbiology 98 General Meeting Workshop Program Practical Approach to the Identification of the Medically Important Glucose Non Fermenting Gram Negative Bacilli American Society for Microbi
64. Modifying Isolate Groups and Test Cards 8 11 Changing the Laboratory Identification Number 8 12 Changing the Isolate Number 8 12 Changing the Organism Name 8 13 Viewing or Updating Patient Specimen Information 8 13 Changing Additional Information and Organism Quantity 8 15 Confirm Changes to the Isolate Group 8 17 ID Card Details 8 18 View Detailed Biochemical Results 8 18 AST Card Details 8 19 View Detailed Antibiotic Results 8 19 Report Selected Antibiotics 8 21 Antibiotics to Suppress 8 21 AES Findings Clinical Use 8 22 Possible AES Findings 8 23 Viewing Detailed AES Report Clinical Use 8 24 Viewing AES Graphic Clinical Use 8 25 Viewing MIC Distributions 8 25 Selecting and Moving a Test 8 27 Viewing Card Details 8 28 Viewing an Isolate Audit Trail 8 28 VITEK 2 Systems Software User Manual 8 1 510773 3EN1 View and Maintain Isolate Results Exporting Results and Raw Data to Electronic Media 8 30 Sending Biopatterns to SRF Industrial Use 8 30 Printing Result Reports 8 31 Lab Report and Chart Report 8 32 Accessing and Printing a Detailed Card Report 8 35 Sending Data to LIS 8 56 Deleting Cards or Isolate Groups 8 37 Ejecting Cards 8 38 Reanalyzing Isolate Results 8 39 Review and Approve Results Configuration 8 40 Reviewing Results 8 40 Reviewing Batch Results 8 40 Approving Results 8 41 Approving Batch Results 8 42 8 2 VITEK 2 Systems Software Us
65. Number plus the Isolate Number Note To enter the Accession ID select the Accession ID cell and then type in the Lab ID number and the Isolate number For details on creating isolate groups see Defining Isolate Group Information on page 4 10 7 8 Select the Organism Name For an AST card select the Organism name from a drop down list by selecting the table cell where you need to enter or select the organism name The status of the card as recorded by the instrument appears in the Message column This column is read only 4 8 VITEK 2 Systems Software User Manual 510773 3ENI Set Up Test Cards and Cassette Information Defining the Selected Cassette 9 Enter the Organism Quantity in the appropriate column Select the table cell where you want to enter the organism quantity and type in a quantity based on your laboratory procedures Note If the cassette defined has already been entered into the system software then this cassette appears in read only mode on the screen The system software also displays the name of the Bench or Setup Tech who entered the information for this cassette The following table defines the card definition columns that appear in the cassette workspace area VITEK 2 Systems Software User Manual 4 9 510773 3EN1 Table 4 2 Card Definition Columns Card Column Description Default Value Slot Lists the cards enumerated based on their location within the cassette 1 10
66. Oct 14 2003 Ren Super feti Oct 14 2003 RenSuper A Aug 17 1998 07 49 49 Det 14 2003 0743 08 SM Ban ipar 10226 macro LOGIN none DPageiofi8 Baak Figure 3 8 Alarm History 4 Click Print to print an instrument report with the information that appears in this window A Print window appears 5 Make the appropriate print selections and click OK 6 The Instrument Status report prints to the workstation printer 3 8 VITEK 2 Systems Software User Manual 510773 3EN1 PART ll SET UP AND MANAGE TEST INFORMATION Wi setup Tests Post Entry VITEK 2 technology SET UP TEST CARDS AND CASSETTE INFORMATION 4 About This Chapter This chapter provides instructions for setting up and maintaining test card isolate and cassette information This chapter also covers entering Quality Control QC information Note If your system software is not yet configured see Chapter 10 Configure and Maintain Workstation Chapter Contents VITEK 2 Systems Workflow 4 2 Using the Set Up Tests Post Entry Workflow 4 2 Filtering Cassettes 4 4 Printing a Blank Cassette Worksheet 4 4 Preparing Test Cards and Cassettes 4 5 Viewing Cassette Information 4 5 Defining the Selected Cassette 4 6 Defining the Cards in the Cassette 4 7 Entering Cassette Worksheet Information 4 8 Defining Isolate Group Information 4 10 Saving Cassette Information 4 11 Printing C
67. PhA o BGAi v MTE eer Poa dMNE opc iam LysA v Py dma aara PHOS dGAL v sac PVvATE v dRIB2 LeuA lapa v NAG Jm los ELM dau v URE dmir da 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 4 11 QC Organism Neisseria lactamica ATCC 23970 ArgA v Pha eme BGAL me Leer ProA dMNE Joc iam v LysA Pya dMAL ANA PHOS dGAL v SAC O PVATE v dRIB2 LeuA lapa v NAG O PHC los ELM v dclu URE dw v dxw 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 4 12 QC Organism Oligella urethralis ATCC 17960 ArgA PheA GLYG BGALi v MTE GGT ProA dMNE ODC v IGLM v LysA v PryA dMAL AARA v PHOS dGAL TyrA SAC PVATE t dRIB2 LeuA APPA v NAG PHC v OPS v ELLM dGLU URE dMLT t dXYL 95 to 100 positive v 6 to 94 positive 0 to 5 positive 4 12 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information Limitations Limitations Do not use the VITEK 2 NH cards with direct clinical samples or other sources containing mixed flora Any change or modification in the procedure may affect the results Newly described or rare species may not be included in the NH database Selected species will be
68. Please PCS lenter values in Ithe required fields and retry 8 5x11 0in Figure 12 30 BCI Alarm History VITEK 2 Systems Software User Manual 12 23 510773 3EN1 Configure and Maintain BCI View and Maintain BCI Status and Alarms Current BCI Alarm Report The Current BCI Alarm Report displays the current BCI alarms to help you troubleshoot the connection WBC Status and Alarm BCI Alarm History Current Aarm Report Printed Mar 10 2004 14 17 One or more of the Mar 10 2004 14 17 D Page 1 of1 Ess5xit0in Z Acknowledge All Messages Figure 12 31 Current BCI Alarms 12 24 VITEK 2 Systems Software User Manual 510773 3EN1 BCI Configuration Settings Configure and Maintain BCI BCI Alarm History Report The BCI Alarm History Report displays the BCI alarm history to help you troubleshoot the connections status WBC Status and Alarm Current BCI Alar Alarm History Report Printed Mar 10 2004 14 19 One or more of he required spe tar 9 2004 information fields Mar 9 2004 10 20 PSP 10 24 lare blank Please enter values in Wie required fields and retry ne or more of the required tar 9 2004 information fields Mar 9 2004 10 22 lare blank Please labsuper 10 24 enter values in he required fields and retry One or more of the required specimen IMar 9 2004 information fields 10 26 lare blank Please enter value
69. Pre dispensed saline test tubes aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 Test tube caps Vortex Procedure For product specific information see Culture Requirements on page 4 20 Note The inoculum must be prepared from a pure culture according to good laboratory practices In case of mixed cultures a re isolation step is required It is recommended that a purity check plate be done to ensure that a pure culture was used for testing 1 Select isolated colonies from a primary plate if culture requirements are met or Subculture the organism to be tested to an appropriate agar medium and incubate accordingly see Table 4 15 2 Aseptically transfer 3 0 mL of sterile saline aqueous 0 45 to 0 5 NaCl pH 4 5 to 7 0 into a clear plastic polystyrene test tube 12x75 mm VITEK 2 Systems Product Information 4 3 532511 4EN1 Results Results NH Product Information 3 Use a sterile stick or swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in step 2 Prepare the homogenous organism suspension with a density equivalent to McFarland No 2 70 to 3 30 using the calibrated VITEK 2 DENSICHEK Note Age of suspension must not exceed 30 minutes before inoculating card 4 Place the suspension tube and NH card in the cassette 5 Refer to the Instrument User Manual for instructions on data entry and how to load the cassette into the instrument 6 Follow
70. Product Information 510774 3EN1 Susceptibility Product Information Performance Characteristics Ura o ef fe ul ue unsiidoyep ef ef ee eof of ex om vw nine Les os fon ose ref o fou eue mer ne ef ef swe of off un ee vo Coffee pL Le peel om cem Cafe of ef eo Cast ol ew of of o ew ae el au eren o1doy jueureaiSy Alo aje u w 18y jenu ssq am aw awa vow am aw awn vaw po wey uowwo 1SV 9Anisod UE JOJ sonsuoepeiey DULWOJ d 1SV 2ARISOd WELID JOJ snsuoepeieu e ueuuoped 21neds jerqoirumuy Z MILIA 9 9 qer VITEK 2 Systems Product Information 6 24 510774 3EN1 Performance Characteristics Susceptibility Product Information 6 25 3 IST t uindoujeull udpis 3 MJS v2 udpjs 3 ISD UI2AU1e1gol uz 3 18497 U IH DU 3 ui2AuloJda1js upexoieds uidweyry upidueyiy m m ur W3S v5 ISD DAL uiue doore SIH XdS va 9po wey uouiu Snia Jeiqonmnunuy jueuieaiSy Alo aje u w 18y jenu ssq LSV 9AHISOd WeID JOJ SHYSH PLILYJ DULWOJ d VITEK 2 Systems Product Information 510774 3EN1 1SV ASOd WELID JOJ sonsuepeiequ DIUBULJOJJOd 21neds Ieido2tupug Z MILIA 9 9 qer Susceptibility Product Information Performance Characteristics ejep eoueuuojed jeuJgju ejep eoueuuojed jeux 3 paseaj 4 0LG uonexsiunupy BNIJ pue poo SN 4 hey 20201daiis g dno1n Joj e8e s pue
71. SRF organisms The SRF biopattern can be associated to the SRF organism to result in a SRF organism call Activate the SRF Organism When 10 SRF biopatterns are associated with the SRF Organism you may activate the SRF Organism for use by the system software during ID analysis Test Organism Review Results Copy Biopattern Create Local SRF Local SRF Fil Py Biop oca iles Agree with to SRF Organism z Identification i Associate Organism Activate O A Reaction File Lines Pere organism Yes No Organism ID Analysis Figure 6 1 SRF Workflow Diagram Copy Biopatterns to SRF Note Any laboratory technologist or supervisor can copy biopatterns to the SRF database however only a supervisor can view and maintain the SRF database information 6 2 VITEK 2 Systems Software User Manual 510773 3ENI Maintain Supplemental React File Industrial Use Copy Biopatterns to SRF When you review organism identification results and the organism meets certain criteria you can copy the biopattern to the local database known as the SRF Database stored in the system software The criteria for copying biopatterns to the database depends on the needs of your individual laboratory Note If the identification card selected to copy to SRF is part of an isolate group the isolate group results status must be final To copy the Biopattern to the SRF Database 1 From View and Maintain Isolate Results v
72. Select isolated colonies from a primary plate if culture requirements are met or Subculture organism to be tested to appropriate agar medium and incubate accordingly 2 Aseptically transfer 3 0 mL of sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 into a clear plastic polystyrene test tube 12 mm x 75 mm 3 Use a sterile stick or swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in step 2 Prepare a homogenous suspension of the organism with a density equivalent to a McFarland No 0 50 to 0 63 using a calibrated VITEK 2 DENSICHEK VITEK 2 Systems Product Information 2 3 069042 5EN1 Results GP Product Information Note Age of suspension must not exceed 30 minutes before inoculating card 4 Place the suspension tube and GP card in the cassette 5 Refer to the User Manuals for the VITEK 2 Instruments for instructions on data entry and how to load the cassette into the instrument 6 Follow your local regulatory agency s guidelines for disposal of hazardous waste Results Identification Analytical Techniques The identification of an organism using the VITEK 2 systems uses a methodology based on the characteristics of the data and knowledge about the organism and reactions being analyzed Sufficient data have been collected from known strains to estimate the typical reactions of the claimed species to a set of discriminating biochemicals If a uniqu
73. Smart Carrier Station Cassettes and actual cassettes as well as quality control tests This view allows you to view and manage test results You can view isolate summary information detailed AST information detailed Biochemical information and AES summary information Result reports can be generated and printed from this view You can also review approve and sign results For details see Chapter 4 Set Up Test Cards and Cassette Information For details see Chapter 8 View and Maintain Isolate Results Manage Patient Information Clinical Use The system software allows you to manage and enter patient and specimen information For details see Chapter 5 Manage Patient Information Clinical Use VITEK 2 Systems Software User Manua 510773 3ENI Getting Started Working in the Software Views TABLE 2 1 MAIN NAVIGATIONAL AREAS OF THE SYSTEM SOFTWARE View Icon Description Location Maintain SRF Data Industrial Use The system software interprets organism identification from biochemical test results using a set of claimed organisms reactions For situations where the organism identification is unclear you will be able to maintain a supplemental react file SRF For details see Chapter 6 Maintain Supplemental React File Industrial Use Manage Quality Control QC e This view allows you to view QC isolate summary information view QC AST d
74. Software Restore database backups Configure system software Approve lab reports Search isolate and application audit trails View previous versions of lab reports 15 2 VITEK 2 Systems Software User Manual 510773 3ENI System Utilities Create and Maintain User and Security Settings Table 13 1 User Group Descriptions Group Comment Laboratory Technologists VITEK 2 System group Log in to VITEK 2 Systems software Perform daily activities supported by the VITEK 2 Systems software Table 13 2 Default User Accounts VITEK 2 Windows XP Systems User ID Password WS Softw te Group Membership Access Admin bmx admin Full None Administrators LabAdmin labadmin Full Full Administrators and Supervisors LabSuper labsuper Limited Full Users and Supervisors LabTech labtech Limited Limited Users and Laboratory Technologists Note For details on creating user accounts and adding users to groups please refer to the operating system user documentation provided with Windows XP Note Itis possible to log into Windows XP as one user and simultaneously log in to the VITEK 2 Systems software as a different user Depending on your laboratory security policies you may want to leave a default user logged in to Windows XP at all times and only require your personnel to log in to the VITEK 2 Systems software application For added security
75. Test Mnemonic Amount Well 62 Phenylphosphonate OPS 0 024 mg 64 D XYLOSE dXLY 0 5 mg Note Other well numbers between 1 and 64 not designated in this table are empty 4 16 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information NH Supplemental Tests NH Supplemental Tests Table 4 14 NH Supplemental Tests Abbreviation Test Name Description Comments Reference CAT CATALASE Colony placed on a drop of hydrogen peroxide produces gas bubbles The bacteria that contain cytochrome enzyme are catalase positive 6 10 COCCI COCCUS SHAPE Coccus round shape of the bacterial cell examined with gram stain 6 10 42C Growth at 42 C Ability of certain species to grow at 42 C AGAR 35C Growth at 35 C nutrient agar Ability of certain species to grow at 35 C on nutrient agar 9 10 25C Growth at 25 C Ability of certain species to grow at 25 C DNAse DNAse Ability of certain species to produce DNAse resulting in the degradation of DNA 9 10 ESCULIN ESCULIN hydrolysis Hydrolysis of esculin forms esculetin that produces a black pigment in the presence of iron salts 6 10 HEMO horse Horse blood hemolysis Certain species possess hemolysins that give a transparent zone around the colonies on blood based agars Hemolysis on 10 horse blood is used as a
76. Type ON Card Lot Number 241010000 Card Expiration Date vear 24 2007 1200 Card Bar Code 2410 1000 0106 3587 Instrument Serial Number 10188761 Instrument Name tek Date Time of Initial Read Sep 29 2003 1509 Date Time of Final Analysis Call Sep 29 2003 2054 Date Time Card Ejected Sep 29 2003 1512 Date Time Last Printed Date Time Last Transferred VITEK 2 compact Software Version o1 01 Cassette ID a Cassette Slot Number H Date Time Cassette Created Sep 29 2003 1606 BPagetof1 E85x11in Lal Figure 8 25 ID Card Details Report Sending Data to LIS Depending on your BCI configuration settings the Isolate information is sent to a Laboratory Information System LIS either automatically or when a user clicks Send Data to LIS By default the isolate information transfers automatically based on your BCI Configuration For details see Chapter 12 Configure and Maintain BCI If Automatic Transfer is disabled or to send the data upon request 1 Select the isolate group that you want to send to the LIS Note Tosendan isolate to an external data management system the isolate must meet the following criteria Isolate is not qualified Isolate is final solate does not need to be reviewed 8 36 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Deleting Cards or Isolate Groups Isolate does not
77. a reaction slightly above the threshold Additional Information on the Lab Report Supplemental test External test which allows the user to resolve slashline or low discrimination identification Contraindicating test Test result that is unusual for a reported taxon Notes associated with certain taxa Table 2 3 Notes associated with certain taxa Note Taxon Highly pathogenic organism check Camp test Listeria monocytogenes and beta hemolysis Possibility of Staphylococcus pasteuri if yellow Staphylococcus warneri pigmented 2 6 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information Additional Information on the Lab Report Table 2 3 Notes associated with certain taxa Possibility of Enterococcus villorum if Enterococcus durans veterinary Notes associated with an improperly filled card or with a negative profile biopattern For the case where the instrument determines that the card has not been filled Terminated card no organism suspension detected Forthe case where the time between two readings is higher than 40 minutes CARD ERROR Missing data Forthe case where there is a negative profile Organism with low reactivity biopattern please check viability When a biopattern is calculated for an unknown organism that is completely negative or consists of both negative tests and tests that fall within the uncertainty zone the identifi
78. added as strains become available Testing of unclaimed species may result in an unidentified result or a misidentification Performance Characteristics In a recent multi site clinical study the performance of the VITEK 2 NH was evaluated using 371 clinical and stock isolates of both commonly and rarely observed species of fastidious organisms The reference identification was determined by 16S rRNA gene sequencing Overall the VITEK 2 NH correctly identified 96 5 of these isolates including 10 2 low discrimination with the correct species listed Misidentifications occurred at 2 7 and no identifications occurred at 0 8 Organisms Identified by the NH Card Actinobacillus ureae Campylobacter coli Campylobacter fetus ssp fetus Campylobacter jejuni ssp jejuni Capnocytophaga spp Cardiobacterium hominis Eikenella corrodens Gardnerella vaginalis Haemophilus actinomycetemcomitans Haemophilus aphrophilus paraphrophilus Haemophilus haemolyticus Haemophilus influenzae Haemophilus parahaemolyticus Haemophilus parainfluenzae Haemophilus segnis Kingella denitrificans Kingella kingae Moraxella Branhamella catarrhalis Neisseria cinerea NEO gt Cocke Dei ba A VITEK 2 Systems Product Information 4 13 532511 4EN1 Organisms Identified by the NH Card NH Product Information Neisseria elongata Neisseria gonorrhoeae Neisseria lactamica Neisseria meningitidis Neis
79. additional information to completely define the selected cassette Show All Workstation displays all cassettes in the active workspace Printing a Blank Cassette Worksheet Before you load a cassette into a VITEK 2 or VITEK 2 Compact instrument you can print a Blank Cassette Worksheet and fill in the appropriate information for the cassette 1 From within the Set Up Tests Post Entry view click Print 4 4 VITEK 2 Systems Software User Manual 510773 3EN1 Set Up Test Cards and Cassette Information Using the Set Up Tests Post Entry Workflow 2 The Print Cassette Report window appears PS LE Print Cassette Report Plesse select the report you went to print ersete Report Bet Cassette Worksheet for Compact F Gg Cassette Workunieet tor VITEK2 VITEK 2 technology Figure 4 4 Print Cassette Report View 3 Select a Blank Cassette Worksheet Blank Cassette Worksheet for Compact Blank Cassette Worksheet for VITEK 2 4 Click Preview to see a read only copy of the blank cassette worksheet 5 Click Print or Preview to print or view a copy of the blank cassette worksheet 6 Usethis worksheet to fill in the specific cassette and card information prior to loading the cassette into the instrument Preparing Test Cards and Cassettes Before loading the test cards you must prepare the test cards For details on preparing test cards for insertion into the instrument see the VITEK 2 Sys
80. and the system software explains the findings Forthe tested organism antibiotic combination the MIC interpretation spans category ranges For example because of the breakpoints an MIC of gt 4 is interpreted as I R In this case the system software will not highlight the blank interpretation in Results view Report Selected Antibiotics Selected antibiotics are displayed in the detailed antibiotic results table in the active workspace This means only antibiotics without the report check box selected appear on the chart report or are sent to an LIS 1 From the View and Maintain Isolate Results view select an AST card 2 Select the check box beside the antibiotic that you do not wish to report 3 The Chart report does not print antibiotics selected to be suppressed Antibiotics to Suppress Note A result for an organism antibiotic combination that may have a limitation listed in the package insert may be suppressed from reporting To select antibiotics to suppress and antibiotics to deduce see Chapter 9 Configuring AST Analysis If an organism antibiotic combination is suppressed AST analysis is complete and AES analysis has been performed the results appear in the active workspace and on the lab report However the results do not appear VITEK 2 Systems Software User Manual 8 21 510773 3EN1 AES Findings Clinical Use View and Maintain Isolate Results on the Chart Report and results are not sent to the
81. choice case is 85 to 99 Values closer to 99 indicate a closer match to the typical pattern for the given organism VITEK 2 Systems Product Information 4 5 532511 4EN1 Additional Information on Lab Report NH Product Information Note Note When the reaction pattern is not sufficient to discriminate between two to three organisms the percent probabilities reflect this ambiguity The reported probability values indicate relatively the order in which the reaction pattern best corresponds to the listed possibilities The order does not however suggest that the pattern match to one of the possible identifications is clearly superior to another The probability characteristic of an overall sum of 100 is retained through the calculation process After resolution to one choice the probability characteristic of the single choice is retained VITEK 2 only Results appear as or The indicates a reaction too close to the threshold to be considered a clear positive or negative reaction VITEK 2 Compact only Results appear as or When a clear positive or a clear negative cannot be determined the result may appear as a weak negative which indicates a reaction slightly below the threshold or a weak positive which indicates a reaction slightly above the threshold Additional Information on Lab Report Supplemental test External test that allows the user to resolve a slashline or Low Discr
82. ci284468 cO01 ct2415 cnSputum Culture c110 15 2 lt RS gt 003 c211 44 c3P c4Preliminary zz lt GS gt 80 lt ACK gt lt ETX gt lt E0T gt ss oo resr LIS1 TheraTrac Unused Unused Vu 686 000 900 500 Figure 12 21 Link Operations Submenu Real Time As additional transactions fill the window a scroll bar appears allowing you to view additional transmissions 3 Click Clear to clear the contents of the window Any problems that occur are reflected by the Alarm icon 4 Click Real Time then Test 5 In the Open screen change the Files of Type option to txt 6 Select test pattern then click Open The test pattern displays If you do not see the test pattern navigate to D Program Files WITEK 2 Compact and select the test pattern text file TestPattern Click BIS to send a Back in Service message to the LIS and click OOS to send an Out of Service message to the LIS Link Configuration The Link Configuration screen allows you to enter parameters for each link Note It is possible to print the BCI configuration using the Tools options in the navigation tree For details see Tools on page 12 20 12 14 VITEK 2 Systems Software User Manual 510773 3ENI Link Configuration Configure and Maintain BCI To access the Link Configuration screen follow these steps 1 From within the Supervision view double click Link Configuration in the navigation tree 2 Click on one of the links
83. codes to create the definition The order of the bar codes on the insert is encoded so that the system software will be able to determine which is the first bar code to be entered The first bar code contains information about the number of antibiotics contained on the card Based on this information the system software can determine the number of bar codes that must be entered to complete the card definition Bar codes can be scanned or entered manually Each bar code has a checksum or another means of validating it after data entry Card definitions cannot be updated if they need to be changed the system deletes the existing card definition and replaces it with a new one that includes the changes You can create and maintain AST card definitions regardless of whether you are operating in Clinical or Industry mode To maintain AST card definitions 1 From the Main view select Utility view gt Maintain AST Card Definitions VITEK 2 Systems Software User Manual 13 7 510773 3EN1 Archive Isolate Reports and Isolate Audit Trail System Utilities 2 Alist of current AST card definitions appears sorted by Card Type The information displayed includes Card Type Card Name User ID who created the definition Date Created when the cards was defined 3 The currently selected card definition appears in the workspace area Card Type AST EXN2 Card Name Gram Negative Susceptibility User ID Smith John Date Creat
84. come to room temperature before opening the package liner Use of a culture medium other than the recommended types must be validated by the customer laboratory for acceptable performance A Gram stain should be performed to determine an organism s Gram reaction and morphology prior to selecting which identification card to inoculate VITEK 2 Systems Product Information 2 1 069042 5EN1 Storage and Handling GP Product Information The card performs as intended only when used in conjunction with VITEK 2 systems Do not use glass test tubes Use clear plastic polystyrene tubes only Variation exists among test tubes of standard diameter Carefully place the tube into the cassette If resistance is encountered discard and try another tube that does not require pressure to insert Ensure that cards are filled properly and do not load any cards that are filled improperly Prior to inoculation inspect cards for tape tears or damage to the tape and discard any that are suspect Check the saline level in the tubes after the vacuum fill Give special consideration to specimen source and patient drug or antimicrobic regimen Interpretation of test results requires the judgment and skill of a person knowledgeable in microbial identification testing Additional testing may be required GP Supplemental Tests on page 2 18 WARNING All patient specimens and microbial cultures are potentially infectious and should be tre
85. dMANNITOL D MANNITOL acidification phenol red supplemental tests dMELIBIOSE D MELIBIOSE acidification bromocresol purple since results of dTREHALOSE D TREHALOSE acidification SE SEN macromethods often IRHAMNOSE L RHAMNOSE acidification differ from rapid SACCHAROSE SACCHAROSE SUCROSE commercial acidification micromethods dFRUCTOSEa D FRUCTOSE assimilation Capability of 2 3 9 10 dGLUCOSEa D GLUCOSE assimilation organisms HIP using a specific sole dMANNITOLa D MANNITOL assimilation Car BOT source dMELa D MELIBIOSE assimilation ISORBOSEa L SORBOSE assimilation Arg hydr ARGININE dihydrolase Hydrolysis of arginine 6 8 9 10 11 releases an amine 15 17 resulting in alkalinization of the medium observed with a pH indicator e g red color formation in the presence of phenol red B HEM BETA HEMOLYSIS Certain species 5 11 17 possess hemolysins that give a transparent zone around colonies on blood based agar 1 20 VITEK 2 Systems Product Information 069041 4EN1 GN Product Information GN Supplemental Tests Table 1 13 GN Supplemental Tests Abbreviation Test Name Description Comments Reference DNAse DNAse test Ability of certain 9 11 17 species to produce DNAse resulting in the degradation of DNA ESCULIN ESCULIN hydrolysis Hydrolysis of esculin 8 9 11 17 forms esculetin that produces a black pigment in the presence of iron salts GELATIN G
86. following antibiotics has been tested OXACILLIN MIC OXACILLIN And The result is R Then The result can be reported for BETA LACTAMS RULE 2 INTERPRETATION GUIDELINES PHENOTYPIC Active If Enterobacteriaceae And One of the following antibiotics has been tested CEFALOTIN Then The result can be reported for CEFAZOLIN CEPHAPIRIN VITEK 2 Systems Software User Manual CT 510773 3EN1 Appendix C AES Antibiotic Deduction Rules RULE 3 INTERPRETATION GUIDELINES PHENOTYPIC Active If Staphylococcus And One of the following antibiotics has been tested KANAMYCIN Then The result can be reported for AMIKACIN ISEPAMICIN RULE 4 INTERPRETATION GUIDELINES PHENOTYPIC Active If Staphylococcus And One of the following antibiotics has been tested GENTAMICIN Then The result can be reported for NETILMICIN RULE 6 INTERPRETATION GUIDELINES PHENOTYPIC Active If Staphylococcus Or Streptococcaceae And One of the following antibiotics has been tested ERYTHROMYCIN Then The result can be reported for AZITHROMYCIN CLARITHROMYCIN DIRITHROMYCIN RULE 7 INTERPRETATION GUIDELINES PHENOTYPIC ACTIVE If Enterobacteriaceae And One of the following antibiotics has been tested NALIDIXIC ACID Then The result can be reported for QUINOLONES 1 Cc VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules RULE 8 INTERPRETATION GUIDELINES PHENOTYPIC Inactive If
87. hollisae formerly known as Vibrio hollisae Mannheimia haemolytica Methylobacterium spp Moraxella group Myroides spp 1 16 V S ITEK 2 Systems Product Information 069041 4EN1 GN Product Information Organisms Identified by the GN Card e Ochrobactrum anthropi Oligella ureolytica Paracoccus yeeii formerly known as CDC group EO 2 Pasteurella aerogenes Pasteurella multocida Pasteurella pneumotropica Photobacterium damselae Plesiomonas shigelloides Pseudomonas aeruginosa Pseudomonas alcaligenes Pseudomonas fluorescens Pseudomonas luteola Pseudomonas mendocina Pseudomonas oryzihabitans Pseudomonas pseudoalcaligenes Pseudomonas putida Pseudomonas stutzeri Ralstonia mannitolilytica Ralstonia pickettii Rhizobium radiobacter Shewanella putrefaciens Sphingobacterium multivorum Sphingobacterium spiritivorum Sphingobacterium thalpophilum Sphingomonas paucimobilis Stenotrophomonas maltophilia Vibrio alginolyticus Vibrio cholerae Vibrio fluvialis Vibrio metschnikovii Vibrio mimicus Vibrio parahaemolyticus Vibrio vulnificus Wautersia paucula formerly known as Ralstonia paucula Highly Pathogenic Organisms e Brucella melitensis e Burkholderia mallei Burkholderia pseudomallei Escherichia coli 0157 e Francisella tularensis Vibrio cholerae Yersinia pestis VITEK 2 Systems Product Information 1 17 069041 4EN1 GN
88. identification card GN is intended for use with VITEK 2 systems for the automated identification of most significant fermenting and non fermenting gram negative bacilli The VITEK 2 GN identification card is a single use disposable For a list of claimed species see Organisms Identified by the GN Card on page 1 14 Description The GN card is based on established biochemical methods 1 12 14 15 17 and newly developed substrates measuring carbon source utilization enzymatic activities and resistance There are 47 biochemical tests and one negative control well The Decarboxylase Negative Control Well well 52 is used as a baseline reference for the Decarboxylase test wells Final results are available in approximately 10 hours or less For a list of well contents see GN Well Contents on page 1 18 Precautions For In Vitro Diagnostic Use Only Suspensions not within the appropriate zone on the VITEK 2 DENSICHEK may compromise card performance Do not use the card after the expiration date shown on the package liner Store the card unopened in the package liner Do not use the card if the protective package liner is damaged or if no desiccant is present Allow the card to come to room temperature before opening the package liner Do not use powdered gloves Powder may interfere with the optics Use of culture media other than the recommended types must be validated by the customer laboratory for accepta
89. if enabled in configuration Note Ifthe instrument name is unknown ie blank the system software will display 222 in the instrument name field LEE VITEK 2 Systems Software User Manual 4 3 510773 3EN1 Using the Set Up Tests Post Entry Workflow Set Up Test Cards and Cassette Information Note A cassette appears in red in the navigation tree when additional information is needed to completely define the selected cassette For details see Defining the Selected Cassette on page 4 6 Filtering Cassettes The Filter option allows you to view and filter the cassettes that appear in the navigation tree To filter cassettes from the Set Up Tests Post Entry view 1 From the first drop down list that appears in the navigation tree select whether you want to filter by Incomplete cassettes default filter or by the Show All option a Setup Tests Post Entry Cassette ID cassette 2 Instrument Simulator Mi incomplete Show All Mar 23 2006 10 37 Cs Mar 23 2006 10 35 CS LaMar 23 2006 10 33 Cs Load Time Mar 23 2006 10 33 CST QC Card Type Bar Code Accession V GN 5649 lATCC6380 029 Prote Iv JAST ONO4 9712 ATCC25922 001 Esch TE Figure 4 3 Setup Tests Post Entry Filter Options Incomplete default Workstation only displays incomplete cassettes from the active workspace Incomplete cassettes appear in red in the navigation tree and require
90. in octal code that represents the reaction pattern profile produced by analysis Place value of 1 2 4 is assigned for positive reactions in each group of three tests and the value in each group is summed to give an integer between zero and seven The computer assigns a bionumber to each set of identification results Call Reactions Card See Test Card Card Lot Number A nine digit number encoded with Card Type Expiration Date manufacturing line and dash number Card Name Official test card name that is given to a product Glossary 2 VITEK 2 Systems Software User Manual 510773 3ENI Card Type Cassette Definition Category Call Confidence Level Contraindicating Tests Data Management System Deduced Antibiotic Demographics Electronic Signature Expected Therapeutic Response Glossary Abbreviated card name consisting of multiple character product name The card type may have an optional dash followed by a 4 character identifier For example GN or AST GNOI The unique code which identifies an individual cassette to the VITEK 2 Systems software It is a combination of the cassette ID and slot number plus a time and date stamp from when the cassette was presented to the instrument The setup information that prepares a cassette for insertion into an instrument Categorical values resulting from a call such as S Susceptibility Intermediate or R Resistant applied to an MIC result A qualitative lev
91. in the package insert by selecting the check box Antibiotics list matches package insert at the bottom of the workspace area 8 Click Save to update the new information 9 Upon confirmation the new card definition is added to the installation s card definitions and the card definition is sent to the instrument 10 All necessary information has now been entered to run and analyze tests using the new AST card Deleting a Card Definition When you are viewing and maintaining the card type from the displayed list you may also want to delete some card definitions 1 From the Maintain AST Card Definition view select the AST Card definitions that you want to delete from the system 15 6 VITEK 2 Systems Software User Manual 510773 3ENI System Utilities Maintain AST Card Definitions 2 Select the definition that you want to delete and click Delete AST Card Type Figure 13 2 Delete AST Card Type 3 If any of the selected cards are currently in the active workspace a message appears letting you know that the card definition cannot be deleted because the card type is actively in use 4 If the card is not in use you will be asked to confirm deleting the card definition 5 When you confirm deleting this card definition the card definition is deleted from the workspace Maintain AST Card Definitions Note When entering a new card type you should have a copy of the package insert that contains the necessary bar
92. is not obtained it is still possible for the reaction pattern to be sufficiently close to that of an expected reaction pattern such that a clear decision can be provided about the organism identification The range of percent probabilities in the one choice case is 85 to 99 Values closer to 99 indicate a closer match to the typical pattern for the given organism When the reaction pattern is not sufficient to discriminate between two to three organisms the percent probabilities reflect this ambiguity The reported probability values indicate relatively the order in which the reaction pattern best corresponds to the listed possibilities The order does not however suggest that the pattern match to one of the possible identifications is clearly superior to another The probability characteristic of an overall sum of 100 is retained through the calculation process After resolution to one choice the probability characteristic of the single choice is retained VITEK 2 only Results appear as or The indicates a reaction too close to the threshold to be considered a clear positive or negative reaction VITEK 2 Compact only Results appear as or When a clear positive or a clear negative cannot be determined the result may appear as a weak negative which indicates a reaction slightly below the threshold or a weak positive 4 which indicates a reaction slightly above the threshold Additional Information o
93. isolate group must belong to the same card class For example the following are considered invalid GN and AST P515 a gram negative ID and a gram positive AST 5 After you confirm the move the system software updates the associated isolate results and the isolate groups If the original isolate group is empty the system software deletes it 6 The workstation reanalyzes the destination isolate group and the original isolate group if necessary Viewing Card Details Depending on which card is selected from within an isolate you can view the detailed laboratory report information by clicking the View Card Details icon x ID Card Details Report Printed Aug 20 2003 1025 342 1 ID GNB Card Lot Number 010470503 Card Expiration Date Dec 6 1997 1200 Card Bar Code 0104 7050 3000 2933 Instrument Serial Number 10188761 Instrument Name Vitek Date Time of Initial Read jug 18 2003 1041 Date Time of Final Analysis Call jug 18 2003 1341 Date Time Card Ejected Aug 18 2003 1042 Date Time Last Printed Date Time Last Transferred VITEK 2 compact Software Version 01 01 Cassette ID 5 Cassette Slot Number d Date Time Cassette Created jAug 18 2003 1040 Figure 8 17 View Card Details 8 28 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Viewing an Isolate Audit Trail Viewing an Isolate Audit Trail When view
94. listing unassociated SRF biopatterns identified by bionumber and grouped by card type VITEK 2 Systems Software User Manual 6 9 510773 3EN1 Maintaining Unassociated SRF Biopatterns Maintain Supplemental React File Industrial Use Viewing Unassociated Biopatterns To view the unassociated biopatterns 1 2 3 4 5 From the Maintain SRF Data view select Unassociated SRF Biopatterns from the View drop down list Select an individual SRF biopattern from the list in the navigation tree The workstation displays information about SRF Biopattern Lab Number Card bar code Date transferred or copied to SRF Bionumber User ID who copied biopattern to SRF Gram Stain Morphology Gram Stain Reaction positive negative variable etc Shape cocci rod coccobacillus etc Comment Colony Morphology free text SRF Biopattern list of biochemicals and reactions Add information to available fields if necessary The system software is updated to reflect the changes For details on linking unassociated biopatterns to SRF Organisms see Linking Associating Biopatterns with SRF Organisms on page 6 11 Deleting an Unassociated SRF Biopattern 1 2 3 From the Maintain SRF Data view select Unassociated SRF Biopatterns from the View drop down list Select an individual SRF biopattern from the list in the navigation tree Click Delete Figure 6 9 Delete Icon 6 10 VITEK
95. may be up to 20 digits in length The number includes a dash and single digit isolate number The length of the Accession ID number determines the number of digits you will have available for autolinking Software that takes instrument MICs Category Calls and an Organism ID and compares them to typical Phenotypes for that Organism AES reports findings in the form of summary statements and propositions Advanced Expert System A drug that kills microorganisms or suppresses their growth Alternate for Antibiotic Testing the susceptibility of certain bacteria to known antibiotic concentrations The test measures the ability of an organism to grow within various concentration levels Software that runs on a computer and performs a designated procedure or process When 21 CFR 11 is enabled archive is the process of saving a copy of isolate reports including all associated audit information from the database to a CD Antimicrobial Susceptibility Test Antimicrobial Susceptibility Test card A test card that measures how an organism is affected by antimicrobial agents The list of bar codes that when entered into Maintain AST Card Definitions introduces a new test kit to the software The process of saving the entire database including VITEK 2 Systems software configuration to a CD Refers to the official interpretation standard a user defined custom interpretation standard is based on ITEK 2 Systems Software User Manual
96. methods for logging out VITEK 2 Systems Software User Manual 2 9 510773 3EN1 Changing Users Getting Started If you want to log out without quitting the application click Logout If you want to log out and Quit the application click Quit If you decide not to log out click Cancel to return to your session Changing Users Changing the user while the application is running consists of logging out without quitting the application The current user must log out before the new user can log in For details see Logging In on Page 2 8 or Logging Out or Quitting the Application on Page 2 9 When the new user logs in to the workstation the system displays any warning or error messages generated since the last time the application was initialized When the new user logs in the workstation displays the work area based on the current state of the cassettes Managing the Inactivity Timer If you are logged on to the system software and you exceed the Inactivity time limit the application will automatically ask you to log in again when you attempt to use the application Note Any unsaved data will not be recovered when the inactivity time limit has been exceeded Customize the Inactivity Timer Note Only a Supervisor can modify the inactivity timer configuration setting You can customize the inactivity timer as needed For more details on customizing the inactivity timer settings see Chapter 10 Customizing the I
97. must have 10 biopatterns associated with SRF organisms to activate the SRF organism 6 Click OK 6 8 VITEK 2 Systems Software User Manual 510773 3ENI Maintain Supplemental React File Industrial Use Deleting SRF Organisms Viewing and Maintaining SRF Organism Information As a supervisor you can maintain SRF organism information From the Maintain SRF view 1 From the Maintain SRF Data view select SRF Organism from the View drop down list 2 Select the specific SRF Organism that you would like to view 3 The following information displays SRF Organism Activation Status upon creation default is inactive SRF Organism Code SRF Organism Name Associated identification card type SRF Organism Comment Deleting SRF Organisms To delete SRF Organisms 1 From the Maintain SRF Data view select SRF Organisms from the View drop down list 2 Select SRF Organism in the displayed list Note If SRF organism is linked to an isolate in the active workspace you cannot delete the SRF organism 3 Click Delete 4 Deleting the SRF Organism also deletes all associated biopatterns The software asks you to confirm deletion of the SRF Organism Click Yes to confirm 5 The selected SRF Organism is removed from the SRF database Maintaining Unassociated SRF Biopatterns When you are viewing and maintaining the unassociated SRF biopatterns the workstation displays the unassociated SRF biopattern workspace
98. organism that you want to associate to the biopattern or select the biopattern you want to associate Note You can use Shift or Ctrl to select multiple biopatterns 4 Select an Organism from the drop down menu 5 Click the Associate Biopattern SRF Organism icon Figure 6 12 Associate Biopattern SRF Organism Icon 6 Repeat selection and association if desired 7 Click Save 8 The system software is updated and the biopattern is now associated with SRF Organism 6 12 VI S I ITEK 2 Systems Software User Manua 510773 3EN1 Maintain Supplemental React File Industrial Use Unassociating Biopatterns from SRF Organisms Unassociating Biopatterns from SRF Organisms To unassociate the SRF biopattern from an existing SRF organism 1 From the Maintain SRF Associations view select SRF Organism 2 Select the SRF biopattern in the displayed list and click the Maintain SRF Organism Association icon 3 The Maintain SRF Association view appears MN ani sin SRF Association SRF Organism and Biopattern Association SRE Organism and Enopafterns Fuss Zero an Crowism z Status sz Accession s Blonumber VITEK 2 technology Figure 6 13 Maintain SRF Association View 4 Select an Organism from the drop down menu 5 Select the bionumber you want to unassociate and click Unassociate Biopattern SRF Organism Figure 6 14 Unassociate Biopattern SRF Organism Icon 6 Click Save VITEK 2
99. provide a percent probability of 99 When a perfect match is not obtained it is still possible for the reaction pattern to be sufficiently close to that of an expected reaction pattern such that a clear decision can be provided about the organism identification The range of percent probabilities in the one choice case is 85 to 99 Values closer to 99 indicate a closer match to the typical pattern for the given organism When the reaction pattern is not sufficient to discriminate between two to three organisms the percent probabilities reflect this ambiguity The reported probability values indicate relatively the order in which the reaction pattern best corresponds to the listed possibilities The order does not however suggest that the pattern match to one of the possible identifications is clearly superior to another The probability characteristic of an overall sum of 100 is retained through the calculation process After resolution to one choice the probability characteristic of the single choice is retained Note VITEK 2 only Results appear as or 2 The indicates a reaction too close to the threshold to be considered a clear positive or negative reaction Note VITEK 2 Compact only Results appear as or When a clear positive or a clear negative cannot be determined the result may appear as a weak negative which indicates a reaction slightly below the threshold or a weak positive 4 which indicates
100. required It is recommended that a purity check plate be done to ensure that a pure culture is used for testing 1 Select isolated colonies from a primary plate if culture requirements are met or Subculture organism to be tested to appropriate agar medium and incubate accordingly 2 Aseptically transfer 3 0 mL of sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 into a clear plastic polystyrene test tube 12 mm x 75 mm VITEK 2 Systems Product Information 1 3 069041 4EN1 Results GN Product Information 3 Use a sterile stick or swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in step 2 Prepare the homogenous organism suspension with a density equivalent to a McFarland No 0 50 to 0 63 using a calibrated VITEK 2 DENSICHEK Note Age of suspension must not exceed 30 minutes before inoculating card 4 Place the suspension tube and GN card in the cassette 5 Refer to the User Manuals for the VITEK 2 Instruments for instructions on data entry and how to load the cassette into the instrument 6 Follow your local inspecting agency s guidelines for disposal of hazardous waste Results Identification Analytical Techniques The identification of an organism using the VITEK 2 systems uses a methodology based on the characteristics of the data and knowledge about the organism and reactions being analyzed Sufficient data have been collected from known st
101. rieux Literal COM1 481 e TheraTrac Unused STOPPED DISABLED DISABLED BACKIN SERVICE bioM rieux Literal COM1 481 Unused Unused Tools LIS1 TheraTrac Unused Unused 600 800 000 600 Figure 12 3 Supervision For each interface name the following global status information is displayed Link Name This is the user defined name given to the connections interface Status Displays the connection status for the user defined links it displays whether they are Started or Stopped STARTED Indicates that BCI is running and therefore allows communication with the selected link STOPPED Indicates that BCI is not running and communication with the selected link is not possible Upload Displays whether the Upload connection is enabled or disabled to send data from the system workstation to the LIS ENABLED BCI allows the applications to send to the host DISABLED BCI does not allow the applications to send to the host 12 4 VITEK 2 Systems Software User Manual 510773 3ENI Supervision Configure and Maintain BCI Download Displays whether the Download connection is enabled or disabled to receive data from the LIS ENABLED BCI processes the message sessions transmitted by the LIS DISABLED BCI does not process the message sessions transmitted by the LIS Host Displays the status of the external data management computer LIS IN SERVICE The LIS is available t
102. sed 8 18 View Detailed Biochemical Results 8 18 AST Card Details oes cep Ripe debt e e baled ee denas 8 19 View Detailed Antibiotic Results 8 19 Unknown Observed Interpretation 8 21 iv VITEK 2 Systems Software User Manual 510773 3ENI Table of Contents Report Selected Antibiotics 8 2 Antibiotics to Suppress 8 21 AES Findings Clinical Use 8 22 Possible AES Findings 8 23 Viewing Detailed AES Report Clinical Use 8 24 Viewing AES Graphic Clinical Use 8 25 Viewing MIC Distributions 8 26 Selecting and Moving a Test 8 27 Viewing Card Details 8 28 Viewing an Isolate Audit Trail 8 29 Exporting Results and Raw Data to Electronic Media 8 30 Sending Biopatterns to SRF Industrial Use 8 30 Printing Result Reports 8 31 Lab Report and Chart Report 8 32 Accessing and Printing a Detailed Card Report 8 35 Det
103. settings required to complete analysis Note The application services must not be running to perform a restore To restore isolate data follow these steps 1 Insert the isolate data backup CD 2 To start the restore Start gt Programs gt VITEK 2 Systems gt VITEK 2 Systems Backup Restore Note A supervisor must log in to access utilities located outside the system software 3 Select the Restore icon 4 When Restore starts up the system software will check to see if the client is running If the client is running the system software notifies you that the restore failed and notes the reason for failure 5 Amessage appears asking you to close the application before running a restore 6 The system software will check for the following items Isolate Data CD has been inserted If the CD is not an isolate data CD you can cancel the restore and insert the appropriate CD The incompatible CD is ejected from the CD drive solate data is compatible with the current system software installed on the system software If the data is not compatible with the installed analysis software you will need to restore the system software to the correct version Then you will be able to restore the isolate data following the appropriate steps 7 When the appropriate CD is available for restoring the system you will be notified that the current user data will be deleted You will be prompted to confirm deleting the current user da
104. slashline identification See the Quality Control Section for more details Frequency of Testing Currently it is recommended to use your most stringent inspecting agency s guidelines for frequency of identification product testing Common practice is to perform QC upon receipt of shipment of the test kits Reactions must follow Online Product Information results If the results do not meet the criteria subculture for purity and repeat test If discrepant results are repeated perform an alternate identification method Testing and Storage of QC Organisms Rehydrate organism according to the manufacturer s instructions Streak organism onto TSA Incubate for 18 to 24 hours Mesophilic species Organisms are incubated at 35 C to 37 C Thermophilic species Organisms are incubated at 54 C to 56 C Check for purity Perform second subculture for testing Storage Conditions Short Term Storage 1 Streak to a TSA plate or slant 5 8 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information BCL Quality Control Table 2 Incubate for 24 hours at 35 C to 37 C or 54 C to 56 C for thermophiles 3 Refrigerate at 2 C to 8 C for up to one week 4 Subculture once as described above and use for QC Long Term Storage 1 Make a heavy suspension in Trypticase Soy Broth with 15 glycerol or Inoculate a slant of TSA supplemented with 5 mg L MnSO to enhance sporulation
105. tested 7 5 Index 8 VITEK 2 Systems Software User Manual 510773 3ENI Index QC reference ID 7 3 QC Results Icons and Descriptions Table 7 2 QC Results Validation Configuration 7 8 7 12 Qualified Isolate 5 5 Qualified Results 9 7 Quality Control See QC Quit the Application 2 9 Reanalyze 8 38 Reanalyze Isolate Results 8 38 Reconciliation view details 4 19 Record Shipment 7 13 Record Shipment of New Cards 7 13 Record Shipments Dialog 7 13 Reports AES report 8 21 archived isolate audit 13 11 archived isolate reports 13 11 AST card details report 8 34 audit trail report 13 17 chart report 8 31 detailed AES report 8 22 8 25 export result report to electronic media 8 29 13 16 ID card details report 8 35 inactive reports 5 8 instrument reports alarm history report 3 7 BCI alarm history report 12 25 current BCI alarm report 12 24 isolate audit report 7 7 8 28 isolate result reports chart report 8 30 detailed AES report 8 30 detailed card report 8 30 laboratory report 8 30 lab report 8 31 lab reports for isolates 5 8 print QC lab reports 7 15 QC reports QC cumulative report 7 18 QC ID card details report 7 17 QC laboratory report 7 16 SRF organism report 6 5 6 16 system reports audit trail report 13 17 view detailed laboratory report 8 27 Restore System Data from Backup CD 14 7 Result Validation Configuration approve QC results 7 9 change comments supervisor approval information 8 16 change sett
106. the completion of incubation MICs are determined for each antimicrobial on the card Reagents AST Card Contents When used with VITEK 2 instrumentation the AST card is a complete system for routine susceptibility testing Each AST card contains selected VITEK 2 Systems Product Information 6 3 510774 3EN1 Precautions Susceptibility Product Information antimicrobials in varying concentrations dried with a microbiological culture medium For a list of antimicrobials and concentrations contained on specific AST cards see the respective package inserts Precautions IMPORTANT For In Vitro Diagnostic Use Only Card performance may be compromised if an organism suspension is used that is not within the appropriate range with the DENSICHEK instrument Do not use the card after the expiration date shown on the package liner Store the card unopened in the package liner Do not use the card if the protective package liner has been damaged or if no desiccant is present Allow the card to come to room temperature before opening Do not use powdered gloves Powder may interfere with the optics Ensure that cards are filled properly and do not load any cards that are filled improperly Prior to inoculation inspect cards for tape tears or damage to the tape and discard any that are suspect Check the saline level in the tubes after the vacuum fill Use of a culture medium other than the recommended types must be
107. the system Organism resistance patterns will differ by institution therefore expected values will be directly related to the population of organisms at each site Performance Characteristics The performance characteristics of the antimicrobial agents included in VITEK 2 AST cards were established at multiple clinical laboratories The VITEK 2 AST card results were compared to results from a reference method prepared according to the CLSI approved procedure Essential agreement EA represents VITEK 2 results that agree exactly with or are within 1 twofold dilution of the reference result 2 twofold dilutions for antifungals Category agreement CA occurs when the VITEK 2 and the CLSI reference interpretative result agree Susceptible Intermediate and Resistant There are instances when the category agreement for an antimicrobial falls below the essential agreement This can occur when a significant number of MICs cluster around a category breakpoint during clinical trial testing resulting in interpretative errors for a description of interpretative errors see the footnote below the tables entitled VITEK 2 Antimicrobial Specific Performance Characteristics When the majority of the errors are of the minor type a high corresponding essential agreement percentage will demonstrate that the antimicrobial retains an acceptable overall performance For US Customers only There are instances when the interpretation is b
108. to a slashline mixed taxa identification This occurs when the biopattern is the same for the taxa listed Supplemental tests may be used to separate slashline taxa The following species belong to the slashline Table 3 1 Slashline mixed Taxa Identification Slashline Name Species Belonging to the Slashline Candida krusei C inconspicua C Candida krusei lambica Candida inconspicua Candida lambica Kloeckera spp Kloeckera apiculata Kloeckera apis Kloeckera japonica 3 4 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Results Table 3 1 Slashline mixed Taxa Identification Rhodotorula glutinis mucilaginosa Rhodotorula glutinis Crypto laurentii Rhodotorula mucilaginosa This is also a pseudoslashline VITEK 2 Systems Product Information 3 5 069043 4EN1 Results YST Product Information Certain species may belong to a pseudoslashline mixed taxa identification A pseudoslashline indicates a rare isolate or rare occurrence of the same biopattern Supplemental tests may be used to separate pseudoslashline taxa The following species belong to the pseudoslashline taxa Table 3 2 Pseudoslashline Taxa Species Belonging Pseudoslashline name ed We Candida sake C famata Candida famata C lipolytica Candida lipolytica Rhodotorula glutinis Cryptococcus laurentii mucilaginosa Crypto laurentii This is also a slashline Id
109. ui2Auojdec W4S W ISD UPAWPUID udpjs ydos I N N o IST co N o D IST yy M W4S Y9 N o 1v9 Va 3 d13 dvd IND ISD d ulexojjoidi5 2 XD E W4S Y9 M o ISD jJo2luayduelo y2 W4S VD IST W SWIXOINJaD Ad Wow U9919S UNIXOjaD pu 7 ISD ui pexo apo eueN uowwo 8nig Jeiqonmnunuy m Me 1 4 g o o m o 82 V29 o m o het o E Ben ul e gt n Hi Hi e e NB jueureaiSy Alo oje u w 18y jenu ssq LSV 9AHISOd WeID JOJ SdI SLa DeIeYD DULWIOJ d 1SV ASOd WEIN JOJ snsuoepeiequ e ueuuoped 2UtDade jerqoirumuy Z MILIA 9 9 qer VITEK 2 Systems Product Information 6 22 510774 3EN1 Performance Characteristics Susceptibility Product Information o a SS ime Mi an nen S66 im el up uuoaun IE ou WAS WD MIH y8IH ubAureuey ydbjs 3 om z upAweuey ISD n N m N N o o n N m o N o o m o M o S z Y Oo ureuediu N 1 o rin lt le o E pepe 0 udpjs 3 Jeqop AYH uney qeH o 2U3 3 W3S V5 18497 ISD DIH U IH upiuejuan udbjs 3 WAS v2 udpjs 3 EI WD uijituejuan V N S z z aweN uoumuo Jeiqonmunuy lt S lt 8 u w 18y jenu ssq LSV 9AHISOd USA JOJ SdI SLa eIeYD e ueuuojled 1SV 9Anisod WELID JOJ SAHSHOPEJELJI e ueuuoped 2UtDade jerqoirumuy Z MILIA 9 9 qer 6 23 VITEK 2 Systems
110. 0 BCI Alarm Status Icons 12 21 View and Maintain BCI Status and Alarms 12 21 Current BCI Alarm Report 12 24 BCI Alarm History Report 12 25 BCI Configuration Settings 12 25 General BCI Configuration Settings 12 26 BCI Upload Tab 12 27 BCI Download Tab 12 28 BCI Translation Tab 12 30 VITEK 2 Systems Software User Manual 12 1 510773 3EN1 Configure and Maintain BCI Introduction Introduction The Bidirectional Computer Interface BCI is installed with the VITEK 2 Systems software BCI requires that you configure additional settings in the system software The BCI Configuration menus must be set up according to the connection protocol developed with your Laboratory Information System LIS computer service company To perform this connection you must call bioM rieux The technical characteristics of the BCI are available from the bioM rieux Global Customer Support CAUTION Configuration and starting of the BCI Bidirectional A Computer Interface eguipment and software reguired for the bioM rieux computer system or for your laboratory information system LIS must be performed by gualified personnel authorized to do so Any unauthorized modification may lead to incorrect operation View and Maintain Connection Status Note BCI must be configured from within the interface connection before you can maintain the system software For details see BCI Configuration Settings on page 12 25 BCI Status vi
111. 005 Active If Enterobacteriaceae And One of the following antibiotics has been tested LOMEFLOXACIN NORFLOXACIN OFLOXACIN Then The result can be reported for LOMEFLOXACIN NORFLOXACIN OFLOXACIN RULE 26 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested AMPICILLIN Then The result can be reported for AMOXICILLIN C6 VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules RULE 27 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested CEFALOTIN Then The result can be reported for CEFACLOR CEFRADINE CEFADROXIL CEFALEXIN CEPHAPIRIN RULE 28 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Acinetobacter baumannii Or Pseudomonas group And One of the following antibiotics has been tested CEFOTAXIME CEFTRIAXONE Then The result can be reported for CEFOTAXIME CEFTRIAXONE RULE 30 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Acinetobacter baumannii Or Pseudomonas group And One of the following antibiotics has been tested LOMEFLOXACIN NORFLOXACIN OFLOXACIN Then The result can be reported for LOMEFLOXACIN NORFLOXACIN OFLOXACIN VITEK 2 Systems Software User
112. 10 Figure 4 11 Figure 4 12 Figure 4 13 Figure 4 14 Figure 4 15 Figure 4 16 Figure 4 17 Sample VISI t NEEN 2 2 Main Mie 2 3 Splash SCEN cyrr nt nn AN a en oa 2 7 Login Breet iii aviona dead ova 2 8 IG NU E 2 9 Logout WIndOW tag d p at de d dte Must ud 2 9 Instrument Status Icon 23 2 Instrument OK Status 23 5 Instrument Warning Status Instrument Error Status Current Instrument Status nn 3 4 Monthly Instrument Status sesenta 3 5 Le 3 6 Lupe 3 8 Enter Manage Cassettes VIEW uns 4 2 Set Up Tests Post Entry VIEW rs 4 3 Setup Tests Post Entry Filter Options ENEE 4 4 Print Cassette Report View EEN 4 5 Card Definition 2 t e e EE 4 7 Define Isolate ICOM aito tette tidie 4 10 Define Isolate Window EENEG 4 11 SAV eo E 4 11 Print Cassette R port sans 4 12 Example Cassette Report ina 4 13 Example Blank Cassette Worksheet EE 4 14 EJEGE ICON TI a 4 15 Maintain Virtual Cassette EENEG 4 17 Create New Virtual Cassette is 4 17 Virtual Cassette Workspace ire 4 18 View Reconciliation Failure Icon tetra 4 19 Delete Virtual Cassette EENEG 4 20 VITEK 2 Systems Software User Manual 510773 3EN1 xi List of Figures Figure 4 18 Set Up QC Test Window urnes 4 24 Figure 5 1 Enter Manage Patient Information View 5 2 Figure 5 2 View and Maintain Patient Information EEN 5 2 Figure 5 3 Add Patient Specimen IC
113. 10773 3EN1 To run and initiate Isolate Data Backup 1 Insert a blank or read write CD 2 Select Start gt Programs gt VITEK 2 Systems gt VITEK 2 Systems Backup Restore 3 If the system software is running you will be prompted to close the application before backup can begin 4 You will then be prompted to log in to the application For details on logging in refer to chapter 2 5 The system software will verify your User ID and password 6 Select the Backup icon End of Day Processing and Daily Maintenance Data Backup and Daily Maintenance 7 Once you log in the system software notifies you that all system software services will be stopped to perform backup 8 You will need to confirm stopping all services If you do not confirm this process no backup takes place 9 Ifthe CD has already been recorded the system software will notify you that the CD contains information and you will be asked to confirm overwriting the CD Choose Yes to continue backup If you choose No the system software returns to the Utilities window 10 The system software checks the CD for use and continues with the backup process 11 If no errors are found isolate data backup is performed 12 The system copies the entire VITEK 2 Systems software database to the CD 13 The workstation ejects the CD 14 The workstation notifies the technologist that the backup is complete 15 Select OK The workstation automatically re
114. 15 Smith SK Sutton DC Fuerst JA Reichelt JL Evaluation of the Genus Listonella and the reassignment of Listonella damsela Love et al MacDonell and Colwell to the Genus Photobacterium as Photobacterium damsela comb nov with an Emended Description Int J Syst Bacteriol 1991 41 529 534 16 U S Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Institutes of Health Office of Health and Safety Biosafety in Microbiological and Biomedical Laboratories 1988 17 Vandamme P Goris J Coenye T Hoste B Janssens D Kersters K DeVos P Falsen E Assignment of Centers for Disease Control group lvc 2 to the genus Ralstonia as Ralstonia paucula sp nov Int J Syst Bacteriol 1999 49 663 669 18 Weyant RS Moss CW Weaver RE Hollis DG Jordan JG Cook EC and Daneshvar MI dentification of Unusual Pathogenic Gram Negative Aerobic and Facultatively Anaerobic Bacteria 2nd Edition Williams 8 Wilkins Baltimore Maryland 1996 VATE S Cored D lt Veber AA en 1 ey VITEK 2 Systems Product Information 1 27 069041 4EN1 Bibliography GN Product Information bioM rieux Inc Use this Online Product Information with VITEK 2 Product No 21341 REP bioM rieux Inc bioM rieux sa Box 15969 au capital de 11 879 045 Euros Durham North Carolina 27704 0969 USA 673 620 399 RCS LYON tel 1 800 682 2666 69280 Marcy l Etoile France tel 33 04 78 87 20 00 fax 3
115. 18 create 4 16 delete 4 19 purpose of 4 16 VITEK 2 Compact System log in 2 8 log out 2 9 navigation 2 3 new features 1 2 operating system modifications 13 2 purpose 1 2 start the system software 2 6 user input 1 7 views configuration 2 5 main view 2 3 maintain cassettes set up tests 2 4 maintain SRF data 2 5 view by manage patient information 2 4 bench 8 4 quality control 2 5 isolate 8 4 system utilities 2 5 eeh view and maintain isolate results 2 4 Index 12 VITEK 2 Systems Software User Manual 510773 3ENI Index Ww Warnings use in manual 1 7 Wells view details for 8 17 well number Glossary 8 VITEK 2 Systems Software User Manual Index 13 510773 3EN1 Index 14 VITEK 2 Systems Software User Manual 510773 3ENI 532501 3EN1 LE VITEK 2 Systems Product Information BIOM IRIEU X bioM rieux Inc Box 15969 Durham North Carolina 27704 0969 USA Tel 1 800 682 2666 EC JREP bioM rieux sa au capital de 11 879 045 673 620 399 RCS LYON 69280 Marcy l Etoile France t l 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 http www biomerieux com b12 Argentina bioM rieux Argentina s a Av Congreso 1745 C1428BUE Capital Federal Buenos Aires tel 54 11 5555 6800 fax 54 11 5555 6888 Australia bioM rieux Australia P L Unit 25 Parkview Business Center 1 Maitland Place Baulkham Hills NSW 2153 tel 61 2 8852 4700 fax 61 2 8852 4777
116. 19ja1 9 qnde sns YUM 3 nsa1 juejsisa1J 10119 Jofeu JW 3 nsa1 92U919 91 1upistsa YUM 3 nsa1 e qndeosns 10419 10feui Aan JWA 1ueureai8e A0893e2 y juou9918e Jenuesse YJ 2180 0IdOHIN ep esieSued 9910S eJ op euiuei8orqnuy 9p 21U102 WAS VD e1mnsu spjepuejs AJOJEJOGE pue eu IS 28H10 juiodyeeiq 3dyg suonemeiqqv VITEK 2 Systems Product Information 6 20 510774 3EN1 Performance Characteristics Susceptibility Product Information uoisngiq gei unixojoo IST jou i U99J2S UHIXOJa3 ui bexo 86 mw s ss sf oe Ad vou jeu 7 uoisnyjiq sia ISTO jeu 3 IST 1SX0 X12 ei ER pes eges ee S86 V N CO vL6 J E IST upnpos uniXojo DUlIxP 0 93 TIENNE uiJozejo urjiprued uij prued Azueg 966 L6 oiday 696 Cof o e se eu s a oo ee of ol sve co of 0 ee omen e mmm en m m ann jueuieaiSy Alo aje u w 18y jenu ssq LSV ASOd WeID JOJ SHYSH PLILYJ DULWOJ d 34 IST WYS w NV uepegins upiduy uljipiduy U PJIUY eueN uouruo jeigoDiunuy 1SV 2ANISOd WELID JOJ SAHSHOPEJELJI e ueuuoped 2UtDade jerqoirumuy Z MILIA 9 2 geL 6 21 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Performance Characteristics J E i0 o oo 1n o M o ie to co o ISD wo UI2PXO JneH WAS V2 IH ploy 2ipisn4 W4S VD UPAUJOJJYAMJ ISD
117. 3 Collins MD Lawson PA The genus Abiotrophia Kawamura et al is not monophiletic proposal of Granulicatella gen nov Granulicatella adiacens comb nov Granulicatella elegans comb nov and Granulicatella balaenopterae comb nov Int J Syst Evol Microbiol 2000 50 365 369 Collins MD Hutson RA Hoyles L Falsen E Nikolaitchouk N Foster G Streptococcus ovis sp nov isolated from sheep Int J Syst Evol Microbiol 2001 51 1147 1150 Coykendall AL Classification and Identification of the Viridans Streptococci Clin Microbiol Rev 1989 2 315 328 Devriese LA Ceyssens K Rodrigues UM Collins MD Enterococcus columbae a species from pigeon intestines FEMS Microbiol Lett 1990 59 3 247 51 Devriese LA Kilpper Balz R Schleifer KH Streptococcus hyointestinalis sp nov from the gut of swine Int J Syst Bacteriol 1988 38 440 441 Elliot JA Facklam RR Antimicrobial susceptibilities of Lactococcus lactis and Lactococcus garvieae and a proposed method to discriminate between them J Clin Microbiol 1996 34 5 1296 1298 Vi S 2 23 ITEK 2 Systems Product Information 069042 5EN1 Bibliography GP Product Information 13 Elliot JA Facklam RR Identification of Leuconostoc spp by analysis of soluble whole cell protein patterns J Clin Microbiol 1993 31 5 1030 1033 14 Euz by Dictionnaire de Bact riologie V t rinaire Autres fichier voir Accueil Mise a jour 02 f vrier 2000 Principau
118. 3 04 78 87 20 90 http www biomerieux com Copyright 2005 bioM rieux Inc All rights reserved DW ae TC PO A EE D Alt Ken AA an 1 28 VITEK 2 Systems Product Information 069041 4EN1 GP PRODUCT INFORMATION 2 Intended Use The VITEK 2 Gram Positive identification card GP is intended for use with VITEK 2 systems for the automated identification of most significant gram positive organisms The VITEK 2 GP identification card is a single use disposable For a list of claimed species See Organisms Identified by the GP Card starting on page 2 13 Description The GP identification card is based on established biochemical methods 2 3 5 9 11 16 19 21 24 25 27 28 and newly developed substrates There are 43 biochemical tests measuring carbon source utilization enzymatic activities and resistance Final identification results are available in approximately eight hours or less For a list of well contents See GP Well Contents on page 2 16 Precautions For In Vitro Diagnostic Use Only Suspensions not within the appropriate zone on the VITEK 2 DENSICHEK may compromise card performance Do not use the card after the expiration date shown on the package liner Store the card unopened in the package liner Do not use the card if the protective package liner is damaged or if no desiccant is present Do not use powdered gloves Powder may interfere with the optics Allow the card to
119. 3 poleaj Jors uonensiurupy NIJ pue pood sn jueuluo upiqionpoadai o1dey ynsai e2u219J21 juezsisai JO e qndeosns YUM Uess ejerpeuuJejul ue JO j nsa1 e2ua19jaJ ejeipeuurejul ue uj JNSOJ 3uejsiseJ JO e qnde sns 1018 JOUIW FW Deal e2ualsja1 e qndeosns uM 3 nsaJ juezsisoi 10119 10feuu JW QNS soUaJajaJ JUPJSISOI uM Une e qnde sns 10418 1ofeuu Aan JWA iueurea8e A089e9 y juaWaaZe Jeuesse V 2I OJOIGODIMJ ep esieSued4 9191205 e ap euiureiSorqnuy 9p JWOD WAS VD IN su sprepueys 103e10qe7 pue erui STD Joao jurodyeauq 1dyg suoneissIqqv soj eoj oo oo oo oof oof cor zl wes oot elo oo oo oo oo oo oor s el w __uphuoruen Sr Es ta s eee eueN uouiuo 5 u w 13y Alo aje JUDUd2I Y Iptuass LSv oDruouinaud sn22020 d2 ns 10 sonsuopeiey e ueuuojiad 6 30 1Sv oDruounoud sn92020 d94 s 10 SISH PLILYJ e ueunoped 2uDade jerqoziumuy Z AILA t 9 9jqer VITEK 2 Systems Product Information 510774 3EN1 Susceptibility Product Information List of Claims Gram Negative Reporting Based on CLSI Important Note Testing and reporting of results for antimicrobial agents with the various non fastidious organism groups is based on the CLSI M100 Performance Standards Table 1 Suggested groupings of U S FDA approved antimicrobial agents that should be considered for routine testing and reporting by clinical laboratories Based on the curr
120. 3EN1 Modifying Isolate Groups and Test Cards View and Maintain Isolate Results Additional Information Organism Quantity Bench You can modify some of the isolate information and card level information The ability to change some of these isolate result fields depends on your system configuration Changing the Laboratory Identification Number To modify information associated with test results 1 From View and Maintain Isolate Results select an isolate group or an individual test card Note If 27 CFR 11 is enabled as a configuration parameter any change made to an isolate group creates a new version of the isolate lab report and indicates a change has been made after final call 2 From the View and Maintain Isolate Results view select the Laboratory Identification Number and make any necessary changes 3 The system software displays a window requesting that you confirm the patient information is correct if patient demographics is enabled in configuration Note Ifthe isolate is complete shown by a green status icon the user must enter a change comment 4 The system software updates the Laboratory Identification Number for all cards in the selected isolate group Changing the Isolate Number If you need to change the isolate number for an isolate group or a particular card in an isolate group 1 From the View and Maintain Isolate Results view select an isolate group or an individual test card Note lf21
121. 5 Viewing and Maintaining SRF Data 6 5 Creating SRF Organisms 6 7 Viewing and Maintaining SRF Organism Information 6 9 Deleting SRF Organisms 6 9 Maintaining Unassociated SRF Biopatterns 6 9 Viewing Unassociated Biopatterns 6 10 Deleting an Unassociated SRF Biopattern 6 10 Linking Associating Biopatterns with SRF Organisms 6 11 Associating a Biopattern to an Existing Organism 6 11 Unassociating Biopatterns from SRF Organisms 6 15 View SRF Biopattern Associations for an Existing SRF Organism 6 14 Activating SRF Organisms 6 14 Deactivating SRF Organisms 6 15 Printing the SRF Biopattern Report 6 15 VITEK 2 Systems Software User Manual 6 1 510773 3EN1 Introduction to SRF Industry Use Maintain Supplemental React File Industrial Use Introduction to SRF Industry Use Note From General Configuration the system software must be set to Industry Mode and SRF must be enabled to work with SRF data For details see General Configuration on page 10 4 The system software interprets organism identification from biochemical test results using a set of claimed organisms reactions For situations where the organism identification meets a certain criteria set by the individual laboratory you can do the following Copy to SRF Copy the biopattern to a supplemental reaction file SRF This supplemental file includes a set of organism definitions known as SRF Organisms Associate a biopattern to
122. 5 Alarm Connection When the alarm state is red click the Alarm icon to open the Event Viewer window For further information call bioM rieux Unused Connection If there is an unused connection all indicator lights appear dark gray Unused 600 Figure 12 6 Unused Connection 12 6 VITEK 2 Systems Software User Manual 510773 3ENI Transaction Log Configure and Maintain BCI Transaction Log The transaction log displays the history of transactions and allows the user to see what isolates have been uploaded or downloaded over time To access the transaction log select Transaction Log from the navigation tree IMPORTANT The connection must be started and uploads enabled in order for transactions to appear in the BCI Transaction Log If BCI is stopped and or uploads are disabled the VITEK 2 Systems software will store the transactions until the port is started and uploads are enabled This means both Automatic Transfer and Send to LIS user initiated transfer uploads are queued in the system software until the port is started and uploads are enabled If the port is started but downloads are disabled any packet received from the LIS will be discarded When the window first appears the transaction log is empty You must first apply a filter to see results bci Transaction Log COM Manager 8 Bt File g Supervision e Ss Stat Date ili o End Date 10 09 2003 Link Operations v LI51 TheraT
123. 510773 3ENI 05 2006 CE VITEK 2 technology Online Software User Manual BIOMERI EU X bioM rieux Inc Box 15969 Durham North Carolina 27704 0969 USA Tel 1 800 682 2666 ec REP bioM rieux SA au capital de 11 879 045 673 620 399 RCS LYON 69280 Marcy l Etoile France t l 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 http www biomerieux com Printed in USA b06 Argentina bioM rieux Argentina s a Av Congreso 1745 C1428BUE Capital Federal Buenos Aires tel 54 11 5555 6800 fax 54 11 5555 6888 Australia bioM rieux Australia P L Unit 25 Parkview Business Center 1 Maitland Place Baulkham Hills NSW 2153 tel 61 2 8852 4700 fax 61 2 8852 4777 Austria bioM rieux Austria GmbH Eduard Kittenberger Gasse 97 Top 5 A 1230 Wien tel 43 186 50 650 fax 43 186 50 661 Belgium bioM rieux Benelux s a n v Media Square 18 19 Place des Carabiniers Bruxelles 1030 tel 32 2 743 01 70 fax 32 2 733 55 97 Brazil bioM rieux Brasil SA Estrada Do Mapu 491 Taquara Jacarepagu CEP 22710 261 Rio de Janeiro RJ tel 55 21 2444 1400 fax 55 21 2455 6099 Canada bioM rieux Canada Inc 7815 Henri Bourassa West Saint Laurent QC H4S 1P7 tel 1 514 236 7321 fax 1 514 807 0015 Chile bioM rieux Chile S A Seminario 131 Providencia Santiago tel 56 2634 20 92 fax 56 2634 20 93 China bioM rieux China Limited 17 Floo
124. 7 Francisella tularensis and Yersinia pestis be sent to your state health laboratory or other suitable reference laboratory for confirmation Storage and Handling Upon receipt store VITEK 2 GN cards unopened in their original package liner at 2 C to 8 C Specimen Preparation For specimen preparation information see the Culture Requirements Table on page 1 24 1 2 VITEK 2 Systems Product Information 069041 4EN1 GN Product Information Materials Materials When used with VITEK 2 instrumentation the GN card is a complete system for routine identification testing of most significant fermenting and non fermenting Gram negative bacilli Required materials are VITEK 2 GN Card VITEK 2 DENSICHEK VITEK 2 DENSICHEK Power Adapter Lithium Battery of DENSICHEK DENSICHEK Calibrator VITEK 2 Cassette Sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 12x 75 mm clear plastic polystyrene disposable test tubes Sterile sticks or swabs Appropriate agar medium See Culture Requirements Table on page 1 24 Optional accessories Saline dispensers Pre dispensed saline test tubes aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 Test tube caps Vortex Procedure For product specific information see the Culture Requirements Table on page 1 24 Note Prepare the inoculum from a pure culture according to good laboratory practices In case of mixed cultures a re isolation step is
125. 8 Test Card Setup Procedure 6 8 Quality Control 6 9 Frequency of QC Testing as defined by CLSI 6 9 Testing and Storage of QC Organisms 6 9 Storage Conditions for QC Organisms 6 10 Results nite Se see pU dede A EEA danas 6 11 Susceptibility Analytical Techniques 6 11 Combination Antibiotics 6 11 Antibiotic Deduction 6 11 Suppression of Results 6 12 Clinical Efficacy a esr es odin ER ERR not 6 12 Urinary Use Only Antimicrobials 6 12 Lifnitati nssz innt eg aceto eo e RA TRUE ele He plis 6 12 Expected Values 6 12 Performance Characteristics 6 13 Gram Negative Reporting Based on CLSI Important Note 6 31 ListiOf e EIER 6 31 Gram Negative Organisms Claimed for AST GN keyid 6 31 Gram Positive Organisms Claimed for AST GP keyid 6 35 Yeast Organisms Claimed for AST YS Keyid 6 36 Bibliography oie seed t s aka see ha Pode Eurus 6 38 VITEK 2 Systems Product Information v 532501 3EN1 Table of Contents vi VITEK 2 Systems Product Information 532501 3ENI GN PRODUCT INFORMATION Intended Use The VITEK 2 Gram Negative
126. 973 The genus Bacillus In Agriculture handbook no 427 pp 283 U S Department of Agriculture Washington D C Logan N A amp Berkeley R C W 1984 Identification of Bacillus strains using the API system J Gen Microbiol 150 1871 Logan N A Carman J A Melling J Berkeley R C W 1985 Identification of Bacillus anthracis by API tests J Med Microbiol 20 75 Logan N A Forsyth G Lebbe L Goris L Heyndrickx M Balcaen A Verhelst A Falsen E Ljungh A Hansson H B DeVos P 2002 Polyphasic identification of Bacillus and Brevibacillus strains from clinical dairy and industrial specimens and proposal of Brevibacillus invocatus sp nov Int J Syst Evol Microbiol 52 953 Logan N A Turnbull P C B 2003 Bacillus and recently derived genera In Manual of Clinical Microbiology 8th Edition pp 445 460 Edited by P R Murray E J Baron M A Pfaller J H Jorgensen amp R H Yolken American Society for Microbiology Washington DC Logan N A amp Berkeley R C W 1981 Classification and identification of members of the genus Bacillus In The Aerobic Endospore forming Bacteria pp 105 140 Edited by R C W Berkeley amp M Goodfellow Academic Press London Nakamura L K Blumenstock L Claus D 1988 Taxonomic study of Bacillus coagulans Hammer 1915 with a proposal for Bacillus smithii sp nov Int J Syst Bacteriol 38 63 Pettersson B Lembke F Hamme
127. A v TyrA ELLM E NAG dTAG OLD LeuA BNAG MdX PLE V dTRE v ESC v PheA APPA AMAN v IRHA INU v TTZ v ProA CDEX v MTE v BGLU v dGLU POLYBR BGAL v dGAL GIyA v BMAN v dRIB v PyrA GLYG B dMAN E PHC PSCNa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 5 10 OC Organism Brevibacillus laterosporus ATCC 64 LMG 16000 BXYL v AGAL z INO dMNE v PVATE v NACI 6 5 LysA AlaA MdG v dMLZ AGLU KAN v AspA V TyrA ELLM v NAG dTAG OLD v LeuA v BNAG v MdX PLE dTRE v ESC v PheA APPA V AMAN v IRHA INU v TIZ V ProA v CDEX x MTE BGLU v dGLU v POLYBR BGAL v dGAL GlyA v BMAN z dRIB v PyrA GLYG dMAN v PHC v PSCNa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 5 11 QC Organism Geobacillus stearothermophilus ATCC 12978 LMG 21890 BXYL AGAL v INO dMNE v PVATE NaCl 6 5 LysA AlaA v MdG dMLZ v AGLU v KAN v AspA v TyrA ELLM v NAG dTAG OLD v LeuA v BNAG MdX PLE v dTRE ESC m PheA t APPA v AMAN IRHA INU TTZ ProA CDEX v MTE v BGLU dGLU POLYB R BGAL dGAL GlyA BMAN dRIB PyrA v GLYG m dMAN PHC B PSCNa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive This organism grows at 54 C to 56 C VITEK 2 Systems Product Informati
128. ACI v dRAF dXYL BGAR V PyrA dGAL V NOVO v O129R v ADHI AMAN V BGUR dRIB V NC6 5 SAL BGAL v PHOS AlaA v ILATk v dMAN SAC AGLU v LeuA V TyrA v LAC dMNE dTRE APPA ProA dSOR v NAG v MBdG dp ADH2s OPTO 4 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 2 11 Recommended QC Organism Streptococcus equi ssp zooepidemicus ATCC 43079 AMY CDEX v BGURr v URE dMAL ip PUL t PIPLC AspA B AGAL POLYB v BACI v dRAF dXYL BGAR 8 PyrA dGAL t NOVO ip O129R v ADHI GP AMAN BGUR v dRIB v NC6 5 v SAL v BGAL v PHOS AlaA dp ILATk dMAN v SAC AGLU v LeuA TyrA dp LAC v dMNE dTRE x APPA v ProA v dSOR v NAG MBdG v ADH2s v OPTO 95 to 100 positive v 6 to 94 positive 0 to 5 positive VITEK 2 Systems Product Information 2 11 069042 5EN1 GP Quality Control Table GP Product Information Table 2 12 QC Organism Streptococcus thermophilus ATCC 19258 amy Tome Bor ue v Iowa Pu PIPLC asa aca Pop v BACI v dRAF v dXYL BGAR PyA dcAL NOVO O129R ADHI AMAN BGUR dRIB NC6 5 SAL BGAL PHOS aaa ILATkK dMAN sac AGLU jte TyrA LAC dMNE v O dTRE APPA Proa v L en NAG MBdG ADH2s OPTO 95 to 100 positive v 6 to 94 posit
129. AFCILLIN PIPERACILLIN TAZOBACTAM TICARCILLIN CLAVULANIC ACID RULE 121 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested IMIPENEM MEROPENEM Then The result can be reported for IMIPENEM MEROPENEM RULE 122 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested BENZYLPENICILLIN Then The result can be reported for AMOXICILLIN AMPICILLIN AZLOCILLIN CARBENICILLIN MEZLOCILLIN PIPERACILLIN TICARCILLIN RULE 281 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Acinetobacter baumannii Or Enterobacteriaceae Or Enterococcus Or Pseudomonas group Or Staphylococcus C 16 VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules And One of the following antibiotics has been tested TETRACYCLINE And The result is S Then The result can be reported for DOXYCYCLINE MINOCYCLINE RULE 282 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterococcus And One of the following antibiotics has been tested BENZYLPENICILLIN Then The result can be reported for AMOXICILLIN AMPICILLIN PIPERACILLIN RULE 283 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If
130. ANCE OPTOCHIN_RESISTANCE VANCOMYCIN_RESISTANCE Ability of certain species to grow in the presence of specific antibacterial compounds 16 17 18 21 NaCl 7 5 PI OR RED GROWTH IN 7 590 NACL PINK ORANGE RED PIGMENT Ability of certain species to grow in the presence of a high concentration of NaCI Ability of certain species to produce pink orange or red colonies on non differential media Characteristic of Kocuria rosea 18 21 SATELLITE SATELLITE behavior Appearance of satellite colonies of nutritionally deficient Streptococcaceae around colonies of Staphylococcus epidermidis Nutritionally deficient Streptococcaceae require nutritional factors supplied by metabolism of colonies of Staphylococcus epidermidis 721 Qn 0 IT EM OO gt Guetta Dedi E mat aa 2 20 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information GP Supplemental Tests Table 2 14 GP Supplemental Tests Abbreviation Test Name Description Comments Reference Str sero A Strepto Serology A Agglutination tests for 1 10 15 17 Str sero B Strepto Serology B Streptococcus groups 18 20 21 22 A B C D and G Str sero C Strepto Serology C Str sero D Strepto Serology D Str sero G Strepto Serology G UREASE Urease Hydrolysis of urea 1718 21 releases ammonia resulting in alkalinization of the medium observed with a pH indicator e g red color form
131. ARAa GRTas V LeuA dGALa v dRAFa dsORa v dGATa v IPROa v ARG v GENa V NAGAI v SACa ESC v 2KGa v ERYa dGLUa dMNEa URE v IGLTA v NAGa V GLYLa LACa dMELa AGLU V dXYLa v dGNTa v TyrA v MAdGa v dMLZa dTURa v LATa v BNAG dCELa v ISBEa dTREa v ACEa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 3 9 OC Organism Geotrichum capitatum ATCC 28576 LysA ir ARBa GGT v IRHAa NO3a CITa IMLTa v AMYa dMALa XLTa IARAa GRTas v LeuA t dGALa v dRAFa dsORa dGATa v IPROa v ARG v GENa E NAGAI SACa Es ESC 2KGa V ERYa dGLUa dMNEa v URE v IGLTA v NAGa v GLYLa v LACa dMELa AGLU dXYLa dGNTa v TyrA MAdGa v dMLza dTURa LATa v BNAG dCELa ISBEa v dTREa ACEa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 3 10 OC Organism Kloeckera apis ATCC 32857 LysA v ARBa v GGT v IRHAa NO3a CITa bg IMLTa AMYa v dMALa v XLTa v IARAa GRTas LeuA dGALa dRAFa dSORa dGATa IPROa ARG GENa NAGAI SACa ESC v 2KGa v ERYa dGLUa dMNEa URE IGLTA NAGa GLYLa LACa dMELa AGLU dXYLa dGNTa TyrA v MAdGa v dMLza dTURa LATa BNAG dCELa v ISBEa dTREa E ACEa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Do WEL A NPP Dedi E 3 12 VITEK
132. ATCC 16529 Trichosporon mucoides ATCC 204094 The organisms below marked with an asterisk indicate additional quality control if required by local regulatory agencies Table 3 6 QC Organism Candida glabrata ATCC MYA 2950 LysA ARBa GGT IRHAa NO3a CITa IMLTa AMYa dMALa XLTa V IARAa GRTas LeuA dGALa dRAFa dsORa dGATa IPROa v ARG v GENa NAGAI v SACa ESC 2KGa S ERYa dGLUa dMNEa URE IGLTA v NAGa GLYLa LACa B dMELa AGLU dXYLa dGNTa v TyrA MAdGa dMLZa dTURa LATa BNAG dCELa ISBEa dTREa ACEa v 95 to100 positive v 6 to 94 positive 0 to 5 positive Table 3 7 OC Organism Candida lusitaniae ATCC 34449 LysA ARBa GGT v IRHAa v NO3a CITa IMLTa AMYa dMALa v XLTa v IARAa GRTas v LeuA dGALa v dRAFa dSORa dGATa v IPROa ARG v GENa V NAGAI v SACa ESC 2KGa ERYa dGLUa dMNEa URE IGLTA NAGa GLYLa v LACa dMELa AGLU v dXYLa v dGNTa v TyrA v MAdGa v dMLZa v dTURa LATa v BNAG dCELa ISBEa E dTREa V ACEa 95 to 100 positive v 6 to 94 positive 0 to 5 positive VITEK 2 SystemsProductlnformaion 3 Il 069043 4EN1 YST Quality Control Table YST Product Information Table 3 8 QC Organism Candida utilis ATCC 9950 LysA ARBa v GGT v IRHAa NO3a CITa v IMLTa v AMYa v dMALa v XLTa v I
133. Add Therapeutic Interpretation 11 20 Printing User Change Report 11 22 VITEK 2 Systems Software User Manual 11 1 510773 3EN1 Accessing AES Configuration View and Configure AES Accessing AES Configuration To access the configuration options for AES 1 From the Main view select Configuration gt AES Configuration from the Configuration drop down menu to view and customize Supervisor only the parameter sets Wain View VITEK 2 technology pei VITEK 2 technology Figure 11 1 Configuration Drop Down Menu with AES Configuration Selected 2 The AES Configuration view appears 11 2 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Accessing AES Configuration Ars Contiguration Iratin Dote d V absten Maximum MK correctione rte Forcing fases MIC interpretations 05 10 515 2005 Tat Thorne rtvezretaton Charges Therapeutic Interpretation CLS M100 515 2005 ratio Decucton by Preech voe ratio Daston by Daer Artisti Figure 11 2 AES Configuration View Note Only a Supervisor with privileges to unlock the AES Configuration view can customize AES Configuration 3 Click the Lock Unlock icon to unlock this view to make changes System AES as configured by bioM rieux These settings have been tested to function per the standards organizations and existing data If you choose to use different criteria you should f
134. Aneurinbacillus aneurinilyticus migulanus Important Presumptive Bacillus anthracis Indentification Notes associated with an improperly filled card or with a negative pro file biopattern For the case where the instrument determines that the card has not been filled Terminated card no organism suspension detected For the case where the time between two readings is higher than 40 minutes CARD ERROR Missing data Forthe case where there is a negative profile Organism with low reactivity biopattern please check viability When a biopattern is calculated for an unknown organism that is completely negative or consists of both negative tests and tests that fall within the uncertainty zone the identification call will be Nonreactive biopattern VITEK 2 Systems Product Information 5 7 069045 2EN1 Quality Control BCL Product Information The following species could potentially trigger this note if a test was atypical or fell within the uncertainty zone Table 5 5 Non Reactive Species Geobacillus thermodenitrificans Geobacillus thermoglucosidasius Quality Control Quality control organisms and their expected results are listed in the VITEK 2 BCL Quality Control Table and should be processed according to the procedure for test isolates outlined in this document The BCL card will identify the quality control organisms as one choice within a low discrimination or
135. Austria bioM rieux Austria GmbH Eduard Kittenberger Gasse 97 Top 5 A 1230 Wien tel 43 186 50 650 fax 43 186 50 661 Belgium bioM rieux Benelux s a n v Media Square 18 19 Place des Carabiniers Bruxelles 1030 tel 32 2 743 01 70 fax 32 2 733 55 97 Brazil bioM rieux Brasil SA Estrada Do Mapu 491 Taquara Jacarepagu CEP 22710 261 Rio de Janeiro RJ tel 55 21 2444 1400 fax 55 21 2455 6099 Canada bioM rieux Canada Inc 7815 Henri Bourassa West Saint Laurent QC H4S 1P7 tel 1 514 236 7321 fax 1 514 807 0015 Chile bioM rieux Chile S A Seminario 131 Providencia Santiago tel 56 2634 20 92 fax 56 2634 20 93 China bioM rieux China Limited 17 Floor Yen Sheng Centre 64 Hoi Yuen Road Kwun Tong Kowloon Hong Kong tel 852 2356 7033 fax 852 2330 2085 Colombia bioM rieux Colombia Ltda Avenida 15 No 100 43 Piso 2 Bogot D C tel 57 1 520 0080 fax 57 1 520 0088 1 520 0831 Denmark bioM rieux Danmark Aps Smedeholm 13C 2730 Herlev tel 45 70 10 84 00 fax 45 70 10 84 01 Finland bioM rieux Suomi Oy Rajatorpantie 41 C 01640 Vantaa tel 358 9 8545 6000 fax 358 9 8545 6045 France bioM rieux SA 69280 Marcy l Etoile tel 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 http www biomerieux com Germany bioM rieux Deutschland GmbH Weberstrasse 8 D 72622 Nirtingen tel 49 7022 30070 fax 49 7022 36110 Gr
136. BGLU dGLU v POLYBR BGAL v dGAL v GIyA v BMAN v dRIB PyrA v GLYG v dMAN PHC v PSCNa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information Limitations Limitations The VITEK 2 BCL card cannot be used with direct microbial samples or other sources containing mixed flora Any change or modification in the procedure may affect the results Newly described or rare species may not be included in the BCL database Selected species will be added as strains become available Testing of unclaimed species may result in an unidentified result or a misidentification The reaction profile contained in the identification database for Bacillus anthracis is based on cultures grown for 15 to18 hours on Trypticase Soy Agar Cultivation on other media or at different incubation times may affect the results Performance Characteristics The database performance of the VITEK 2 BCL was evaluated using 1436 isolates of both commonly and rarely observed species of Gram positive aerobic spore forming bacilli The reference identification was determined with the api 50CHB identification kit and other conventional test methods Overall the VITEK 2 BCL correctly identified 96 1 of the isolates including 9 3 low discrimination with the correct species listed Misidentifications occurred at 2 6 and no identifications occurred
137. C VALUES ESBL POS or NEG Beta lactamase POS or NEG Synergy SYN S or SYN R VRSA Screen POS or NEG Cefoxitin Screen POS or NEG Interpretation Expertization interpretation is based on the MIC Interpretation Guidelines Use CTRL click to change the MIC interpretation For an antibiotic the following are available interpretations TABLE 8 5 ANTIBIOTIC INTERPRETATIONS S Susceptible l Intermediate R Resistant These interpretations are available for the following tests TABLE 8 6 TEST INTERPRETATIONS ESBL ft Or Beta lactamase or Oxacillin SorR 8 20 VITEK 2 Systems Software User Manual 510773 3ENI View and Maintain Isolate Results AST Card Details TABLE 8 6 TEST INTERPRETATIONS Synergy SorR VRSA Screen or Cefoxitin Screen or Unknown Observed Interpretation In some instances the VITEK 2 Systems software may allow you to see an MIC for a tested antibiotic but not an interpretation on the lab report or in the Results view Reasons why an observed interpretation can be unknown Oe blank No breakpoints are defined in the active parameter set MIC Guideline for the tested organism antibiotic combination Partial breakpoints defined Unusual MIC in the active parameter set MIC Guideline for the organism antibiotic combination In this case the blank interpretation is highlighted
138. CIN RULE 63 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Enterobacteriaceae And One of the following antibiotics has been tested CIPROFLOXACIN LEVOFLOXACIN Then The result can be reported for CIPROFLOXACIN LEVOFLOXACIN RULE 64 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Acinetobacter baumannii Or Pseudomonas group And One of the following antibiotics has been tested MEZLOCILLIN TICARCILLIN Then The result can be reported for MEZLOCILLIN TICARCILLIN C 14 VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules RULE 101 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested OXACILLIN MIC OXACILLIN And The result is S Then The result can be reported for AMOXICILLIN CLAVULANIC ACID AMPICILLIN SULBACTAM CEFACLOR CEFADROXIL CEFALEXIN CEFALOTIN CEFAMANDOLE CEFAZOLIN CEFDINIR CEFDITOREN CEFEPIME CEFMETAZOLE CEFONICID CEFOPERAZONE CEFOTAXIME CEFOTETAN CEFOXITIN CEFPODOXIME CEFRADINE CEFROZIL CEFTAZIDIME CEFTIZOXIME CEFTRIAXONE CEFUROXIME CEFUROXIME AXETIL CEPHAPIRIN CLOXACILLIN DICLOXACILLIN ERTAPENEM IMIPENEM LATAMOXEF LORACARBEF VITEK 2 Systems Software User Manual C 15 510773 3EN1 Appendix C AES Antibiotic Deduction Rules MEROPENEM METHICILLIN N
139. Card Report NONE ee gt a p4 VITEK 2 technology Figure 7 10 Select a Result Report Type 2 Select a Result Report type from the following QC Laboratory Report QC Detailed Card Report QC Cumulative Reports Only Available if a QC filter has been applied 7 14 VITEK 2 Systems Software User Manual 510773 3EN1 Maintain Customer Quality Control Printing QC Laboratory Reports 3 Click Print Preview or Cancel When you select an isolate and choose the Print option the event is captured in the Isolate Audit Trail report The Date Time Printed field for the report also updates each time an isolate level report is selected and printed Note Ifa card under an isolate is selected and printed neither the Isolate Audit Trail report nor the Date Time Printed field for the selected report update to reflect the event QC Laboratory Report The QC Laboratory report prints the QC card results WC Lab Report bioM rieux Customer QC Laboratory Report Printed Oct 7 2003 1418 System By sjones QC Reference ID ATCC35218 Last Updated Oct 2 2003 1230 By sjones Comments ast Card information Card AST GNO4 Lot 101288040 Expires Nov 29 2003 Completed Sep 24 2003 0265 Status Final 1 6 hrs Organism ID Escherichia coli ATCC 35218 Organism Entered By sjones Entered Oct 2 2003 1230 AST Analysis Messages Antibiotic Details Antibiotic Actual Expected
140. Citrobacter amalonaticus Citrobacter braakii e Citrobacter farmeri Citrobacter freundii e Citrobacter koseri e Citrobacter sedlakii Citrobacter youngae e Edwardsiella hoshinae e Edwardsiella tarda Enterobacter aerogenes Enterobacter amnigenus 1 e Enterobacter amnigenus 2 Data on file at bioM rieux Inc 1 14 V P ITEK 2 Systems Product Information 069041 4EN1 GN Product Information Organisms Identified by the GN Card Enterobacter asburiae Enterobacter cancerogenus Enterobacter cloacae Enterobacter gergoviae Enterobacter intermedius Enterobacter sakazakii Escherichia coli Escherichia coli 0157 Escherichia fergusonii Escherichia hermannii Escherichia vulneris Ewingella americana Hafnia alvei Klebsiella oxytoca Klebsiella pneumoniae ssp ozaenae Klebsiella pneumoniae ssp pneumoniae Klebsiella pneumoniae ssp rhinoscleromatis Kluyvera ascorbata Kluyvera cryocrescens Leclercia adecarboxylata Moellerella wisconsensis Morganella morganii ssp morganii Morganella morganii ssp sibonii Pantoea agglomerans Pantoea spp Proteus mirabilis Proteus vulgaris group Proteus penneri Providencia alcalifaciens Providencia rettgeri Providencia rustigianii Providencia stuartii Rahnella aquatilis Raoultella ornithinolytica Salmonella enterica ssp arizonae formerly known as Salmonella choleraesuis ssp arizonae
141. Clinical Laboratory Standards M29 A Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline 1997 24 Poyart C Quesne G Trieu Cuot P Taxonomic dissection of the Streptococcus bovis group by analysis of manganese dependent superoxide dismutase gene sodA sequences reclassification of Streptococcus infantarius subsp coli as Streptococcus lutetiensis sp nov o aa 22g M MM MMwnEv 4cCotorme Dohi din nema aa 2 24 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information 25 26 27 28 Bibliography and of Streptococcus bovis biotype 11 2 as Streptococcus pasteurianus sp nov Int J Syst Evol Microbiol 2002 52 1247 1255 Schlegel L Grimont F Collins MD Regnault B Grimont PAD Bouvet A Streptococcus infantarius sp nov Streptococcus infantarius subsp infantarius subsp nov and Streptococcus infantarius subsp coli subsp nov isolated from humans and food Int J Syst Evol Microbiol 2000 50 1425 1434 U S Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Institutes of Health Office of Health and Safety Biosafety in Microbiological and Biomedical Laboratories 1988 Viera VV Teixeira LM Zahner V Momen H Facklam RR Steigerwalt AG Brenner DJ Castro ACD Genetic
142. D sjones Password Figure 2 4 Login Screen 3 If you are an authorized user the system software opens and you can begin working in the application If you are unable to access the application due to an invalid User ID and Password a message appears After several attempts if you still cannot access the application your user account will be locked Note Supervisor Only As a supervisor you retain more extensive rights regarding maintaining user accounts When logging in to the system software you may be prompted to clear locked User IDs 2 8 VITEK 2 Systems Software User Manual 510773 3EN1 Getting Started Logging Out or Quitting the Application Logging Out or Quitting the Application There are two methods for logging out of the system software You can choose to quit the application or you can click the Login icon or click the X in the upper right corner of the screen Logout ends the current session and you cannot continue using the application until you have logged in again While Logout keeps the application open and running quitting the application automatically logs the user out and closes the application session and window To regain access to the system software you must start the application again and log in To log out or quit the application 1 Click the Login icon Figure 2 5 Login icon 2 The Logout window appears LEE Figure 2 6 Logout window 3 There are several
143. E BGUR 0 0378 mg 28 Alanine ARYLAMIDASE AlaA 0 0216 mg 29 Tyrosine ARYLAMIDASE TyrA 0 0276 mg 30 D SORBITOL dSOR 0 1875 mg 31 UREASE URE 0 15 mg 216 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information Table 2 13 GP Well Contents GP Well Contents Well Test Mnemonic Amount Well 32 POLYMIXIN B RESISTANCE POLYB 0 00093 mg 37 D GALACTOSE dGAL 0 3 mg 38 D RIBOSE dRIB 0 3 mg 39 L LACTATE alkalinization ILATk 0 15 mg 42 LACTOSE LAC 0 96 mg 44 N ACETYL D GLUCOSAMINE NAG 0 5 mg 45 D MALTOSE dMAL 0 5 mg 46 BACITRACIN RESISTANCE BACI 0 0006 mg 47 NOVOBIOCIN RESISTANCE NOVO 0 000075 mg 50 GROWTH IN 6 5 NACI NC6 5 1 68 mg 52 D MANNITOL dMAN 0 1875 mg 55 D MANNOSE dMNE 0 5 mg 54 METHYL B D GLUCOPYRANOSIDE MBdG 0 5 mg 56 PULLULAN PUL 0 5 mg 57 D RAFFINOSE dRAF 0 5 mg 58 O 129 RESISTANCE comp vibrio O129R 0 0084 mg 59 SALICIN SAL 0 5 mg 60 SACCHAROSE SUCROSE SAC 0 5 mg 62 D TREHALOSE dTRE 0 5 mg 63 ARGININE DIHYDROLASE 2 ADH2s 0 27 mg 64 OPTOCHIN RESISTANCE OPTO 0 000399 mg Note Other well numbers between 1 and 64 not designated in this table are empty Vi S 2 17 ITEK 2 Systems Product Information 069042 5EN1 GP Supplemental Tests GP Supplemental Tests Table 2 14 GP Supplemental Tests Abbreviation Test Name Description Comments Reference A HEM ALPHA HEMOLYSIS Certain species produce 1718 19 21 incomple
144. ELATIN hydrolysis Mediated by a 5 10 11 14 gelatinase enzyme a positive reaction is observed by liquefaction of the gelatin substrate IND INDOLE Ability of certain 6 8 9 11 17 species to split indole from tryptophan detected by a colored product revealed with a specific reagent e g Kovacs Ehrlich s DMAC reagents etc Lysine dec Lysine decarboxylase Hydrolysis of lysine Some tests also 12 releases an amine appear on the GN resulting in card but are alkalinization of the recommended as medium observed supplemental tests with a pH indicator since results of e g purple color conventional formation in the macromethods often presence of differ from rapid bromcresol purple commercial micromethods MOB MOTILITY Test for motility using Bacterial motility can 3 8 9 11 15 hanging drop be observed by 17 procedure or saline placing a drop of mount bacterial suspension on a slide and viewing it under a microscope VITEK 2 Systems Product Information 1 21 069041 4EN1 GN Supplemental Tests GN Product Information Table 1 13 GN Supplemental Tests Abbreviation Test Name Description Comments Reference NAT SODIUM ACETATE Ability of certain 18 alkalinisation species to utilize acetate as a sole source of carbon NO2 NITRITE REDUCTION Test for the ability to 6 11 18 NO3 NITRATE REDUCTION reduce nitrate to nitrogen gas NO2 NO3 gt N2 NITROGEN P
145. ENI Numerics 21 CFR 11 archive all isolates 15 9 change setup tech name 7 6 change to isolate group 8 11 deleted isolates cleanup 14 5 enabled 4 6 Access All System Software Views 2 5 Access Configuration Views 10 2 Accession 4 8 4 9 Accession ID 4 8 Accessories additional supplies 1 2 Active Workspace aged messages removed from 14 5 card definition in 15 8 cassette management cleanup 14 5 cassette specific information in 4 5 deleted isolates in 14 5 detailed antibiotic results 8 19 isolate information cleanup 14 4 older tests deleted from 15 9 QC result information 7 3 system software links isolate with a single patient in 5 4 links patient to one or more isolates in 5 4 test results 8 5 view MIC Interpretation Guideline 11 11 Actual Cassette cassette saved as 4 16 switch view from virtual cassette 4 16 Add Patient Specimen Window 5 4 Add Specimen 5 4 Additional Information Dialog 8 15 Additional Isolate Information Window 8 15 Additional Supplies 1 2 AES Configuration access configuration options 11 2 customize 11 4 11 9 results expertized based on lab parameters 8 21 AES Findings AES analysis problems 9 7 AES graphic in determining options 8 21 to view 8 25 background information 8 21 detailed AES report 8 21 levels of confidence 8 22 phenotypes 8 21 AES Parameter Set MIC interpretation guideline 11 4 therapeutic interpretation guideline 11 4 Aged Isolates 5 8 Alarm Connection 12 6 Alarm Histor
146. GLYG E dMAN PHC v PSCNa 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 5 7 QC Organism Bacillus circulans ATCC 61 LMG 16633 BXYL AGAL INO v dMNE PVATE v NaCl 6 5 v LysA AlaA v MdG dMLZ AGLU ip KAN v AspA ar TyrA t ELLM v NAG dTAG OLD v LeuA BNAG v MdX v PLE v dTRE v ESC PheA GP APPA AMAN IRHA v INU ip TIZ v ProA GP CDEX v MTE BGLU v dGLU ip POLYBR v BGAL GP dGAL GlyA a BMAN dRIB v PyrA v GLYG dMAN v PHC PSCNa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 5 8 Recommended QC Organism Bacillus licheniformis ATCC 12759 LMG 7560 BXYL AGAL v INO dMNE PVATE Nacl 6 5 LysA v AlaA v MdG dMLZ AGLU v KAN v AspA TyrA ELLM NAG dTAG OLD LeuA v BNAG v MdX PLE dTRE ESC PheA APPA v AMAN v IRHA v INU v TIZ v ProA CDEX MTE BGLU dGLU POLYBR v BGAL GP dGAL v GIyA v BMAN v dRIB v PyrA GLYG v dMAN PHC v PSCNa 95 to 100 positive v 6 to 94 positive 0 to 5 positive 5 10 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information BCL Quality Control Table Table 5 9 QC Organism Brevibacillus agri ATCC 51663 LMG 15103 BXYL AGAL V INO dMNE PVATE v NaCl 6 5 LysA v AlaA v MdG v dMLZ AGLU v KAN v Asp
147. I connection status 12 2 QC isolate audit records 7 6 view maintain SRF database 6 2 8 29 Supplemental React File See SRF Supplemental Tests 8 16 Supplies additional 1 2 Suppressed Antibiotics not printed on chart report 8 51 Symbols standard use in manual 1 7 1 8 Symbols standard 1 10 System Mode Index 10 VITEK 2 Systems Software User Manual 510773 3ENI Index select clinical or industry mode 10 7 System Reports audit trail report 13 17 System Software AES expertise component 11 9 automated input of test setup information 4 7 backup backup failure 14 2 lab tech initiated data backup 14 3 system initiated nightly backup 14 2 card information automatically entered 4 2 cassettes currently loaded 4 3 change user 2 10 configure batch selection of isolates 9 9 for industry mode 6 2 configured for reviewing QC results validation 7 9 daily workspace maintenance 14 4 electronic signature 7 9 end of day processing alarm management cleanup 14 5 automatically initiated 14 4 cassette management cleanup 14 5 deleted isolates cleanup 14 5 instrument status management cleanup 14 5 isolate information cleanup 14 4 patient information cleanup 14 4 QC management cleanup 14 4 interface communication links 12 9 interprets organism identification 6 2 links isolate with a single patient 5 4 patient with one or more isolates 5 4 list of MIC values 11 14 local database SRF database 8 29 log in 2 8 log out 2 9 na
148. INTAIN WORKSTATION 10 About This Chapter This chapter covers customizing General Configuration viewing Versions of Installed Components and maintaining System and Instrument Status and Alarms Note Both a Laboratory Technologist and a Supervisor can view configuration settings however only a supervisor can modify the configuration parameters Chapter Contents Accessing Configuration Views 10 2 Unlock Lock Configuration View for Changes 10 3 Save or Cancel Configuration Changes 10 4 General Configuration 10 4 Customizing General Configuration Supervisor Only 10 5 System Information 10 5 System Mode and Options 10 6 Setting the System Mode 10 7 Customizing the Inactivity Timer 10 7 Moving Isolates to Inactive 10 7 Maximum Logon Attempts 10 8 Print Settings 10 8 Miscellaneous 10 9 Setting Up and Creating New Benches Clinical Use 10 9 Modifying Organism Quantity 10 10 Enabling Patient Demographics Clinical Use 10 10 Enabling Automatic Daily Backup 10 10 Viewing Versions of Installed Components 10 11 VITEK 2 Systems Software User Manual 10 1 510773 3EN1 Accessing Configuration Views Configure and Maintain Workstation Accessing Configuration Views The following components are available for configuration View Versions of Installed Components General Configuration Results Validation See Results Validation Configuration on page 9 6 BCI Configuration See BCI Configu
149. Isolate recovered from a urine specimen Isolate Group A collection of Test Cards used to test an solate The Isolate Group is created by the Microbiologist during setup and groups cards based on the Laboratory Identification Number Isolate Number and Cassette Isolate Number The number following the dash on an Accession ID that refers to a specific isolate Isolate numbers can include the digits 1 to 99 Knowledge Base The database of raw data reference identifications and algorithm parameters used for a particular product e g GP Glossary 4 VITEK 2 Systems Software User Manual 510773 3ENI LIS Lab Information System Laboratory Identification Number Load Time Lot number Low Discrimination Minimum Inhibitory Concentration Natural Resistance Negative Reaction Organism ID Organism Quantity Patient Pathogenic Glossary Laboratory Information System A computer system used to collect and report laboratory data A number used to identify a laboratory culture It can be assigned manually or by the Lab Information System Values of up to 20 alphanumeric characters are allowed Indicated when the cassette was loaded into the instrument the month date and the time expressed in hours minutes and seconds Each lot of test cards has a unique identification called the lot number which is assigned by the manufacturer If you receive two or more shipments from the same lot the VITEK 2 Syste
150. LIS For more information see Chapter 9 Configuring AST Analysis AES Findings Clinical Use The Advanced Expert System AES is a software program for the validation and interpretation of VITEK 2 Systems susceptibility results When biologic validation is enabled AES automatically checks susceptibility results as the VITEK 2 System analysis program processes them Susceptibility AST results are further analyzed using AES in an effort to validate the results and detect resistant phenotypes The AES findings appear on the View and Maintain Results view in the upper right corner VU view and Maintain folate Results TO Pyersctc inrobscim caron Cienie Acid VITEK 2 technology Figure 8 14 AES Findings AES compares observed instrument MIC results and the organism identification to a knowledge base of expected MIC distributions AES determines what phenotypes are being expressed by the organism 8 22 VI S I ITEK 2 Systems Software User Manua 510773 3EN1 View and Maintain Isolate Results AES Findings Clinical Use If AES detects differences or inconsistencies there may be a technical error for example a mixed culture or the organism is more susceptible or resistant than the AES expected results Thus AES can recognize and inform the user about emerging resistance patterns The detailed AES Report and the AES Graphic can help you to determine and consider all of the possible op
151. M H2S dMAN URE E ILATk V LDC ILATa BNAG dMNE V dSOR AGLU IHISa 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 1 9 OC Organism Proteus vulgaris ATCC 6380 APPA AGLTp H BXYL SAC SUCT v CMT ADO dGLU BAlap dTAG NAGA BGUR PyrA GGT V ProA v dTRE AGAL O129R IARL OFF V LIP v CIT v PHOS Es GGAA dCEL BGLU PLE v MNT GlyA IMLTa BGAL dMAL v TyrA v 5KG ODC ELLM H2S dMAN H URE ILATk v LDC ILATa BNAG dMNE dSOR AGLU V IHISa 95 to 100 positive v 6 to 94 positive 0 to 5 positive D VITEK 2 Systems Product Information 069041 4EN1 GN Product Information GN Quality Control Table Table 1 10 QC Organism Shigella sonnei ATCC 25931 APPA AGLTp z BXYL SAC SUCT v CMT ADO dGLU BAlap dTAG NAGA BGUR PyrA GGT ProA v dTRE AGAL v O129R v IARL OFF v LIP v CIT PHOS GGAA dCEL BGLU PLE MNT GlyA v IMLTa v BGAL GP dMAL TyrA 5KG z ODC ELLM v H2S v dMAN URE v ILATk v LDC ILATa v BNAG dMNE dSOR AGLU v IHISa 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 1 11 OC Organism Stenotrophomonas maltophilia ATCC 17666 APPA AGLTp BXYL SAC e SUCT v CMT ADO dGLU v BAlap dTAG NAGA BGUR PyrA GGT v ProA dTRE AGAL O129R IARL OFF LIP CIT v PHOS GGAA dCEL BGLU v PLE MN
152. MAN SAC AGLU t LeuA v TyrA LAC v dMNE dTRE APPA v ProA dSOR NAG MBdG ADH2s OPTO 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 2 8 QC Organism Staphylococcus aureus ssp aureus ATCC 29213 AMY CDEX BGURr URE dMAL E PUL PIPLC AspA AGAL POLYB v BACI a dRAF dXYL BGAR za PyrA dGAL v NOVO v O129R ADHI ae AMAN BGUR dRIB V NC6 5 E SAL BGAL v PHOS AlaA ILATk dMAN SAC AGLU v LeuA V TyrA LAC V dMNE dTRE APPA ProA dSOR NAG v MBdG ADH2s v OPTO 95 to 100 positive v 6 to 94 positive 0 to 5 positive 2 20 WITEK 2 Systems Product Information 069042 5EN1 GP Product Information GP Quality Control Table Table 2 9 QC Organism Staphylococcus saprophyticus ATCC BAA 750 AMY CDEX BGURr URE dMAL ES PUL PIPLC AspA AGAL POLYB BACI E dRAF dXYL BGAR PyrA v dGAL V NOVO ar 0129R v ADHI v AMAN BGUR dRIB V NC6 5 a SAL BGAL E PHOS V AlaA ILATk v dMAN SAC AGLU v LeuA TyrA LAC dMNE v dTRE APPA v ProA B dSOR m NAG V MBdG ADH2s OPTO 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 2 10 QC Organism Staphylococcus sciuri ATCC 29061 AMY CDEX BGURr URE dMAL PUL PIPLC AspA AGAL POLYB B
153. Maintaining SRF Organisms Supervisor Creating and Maintaining SRF Organisms Supervisor Viewing and Maintaining SRF Data When the system software is configured for Industry Mode you can access the SRF view by following these steps 1 From the Main view click the SRF icon to access the Maintain SRF Data view 2 The Maintain SRF Data view appears SRF Biopattern Details Transfer tout Aug 19 2003 0000001000030 VITEK 2 technology Figure 6 4 View and Maintain SRF Data View 3 From the Maintain SRF Data view you can Associate the SRF organism to an Unassociated biopattern Create an organism Delete the SRF organism Print the SRF Report 4 You can view the following SRF Data from the navigation tree Unassociated Biopatterns VITEK 2 Systems Software User Manual 6 5 510773 3EN1 Creating and Maintaining SRF Organisms Supervisor Maintain Supplemental React File Industrial Use SRF Organisms must have 10 biopatterns associated with SRF organisms to activate Note If SRF Organisms are not yet created no information appears on the SRF organism view 342 1 00000100202160 VITEK 2 technology Figure 6 5 Unassociated Biopattern View 6 6 VITEK 2 Systems Software User Manual 510773 3EN1 Maintain Supplemental React File Industrial Use Creating and Maintaining SRF Organisms Supervisor Figure 6 6 SRF Organism View Creating SRF Organisms Not
154. Manual C 7 510773 3EN1 Appendix C AES Antibiotic Deduction Rules RULE 31 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested AZITHROMYCIN CLARITHROMYCIN ERYTHROMYCIN Then The result can be reported for AZITHROMYCIN CLARITHROMYCIN ERYTHROMYCIN RULE 32 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested CIPROFLOXACIN LEVOFLOXACIN OFLOXACIN Then The result can be reported for CIPROFLOXACIN LEVOFLOXACIN OFLOXACIN RULE 33 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested LOMEFLOXACIN NORFLOXACIN Then The result can be reported for LOMEFLOXACIN NORFLOXACIN CB VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules RULE 34 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested BENZYLPENICILLIN And The result is S Then The result can be reported for AMINO PENICILLINS AMINO PENICILLINS BETA LACTAM INHIBITOR CEFACLOR CEFADROXIL CEFALEXIN CEFDINIR CEFDITOREN CEFPROZIL CEPHAPIRIN CEFALOTIN CEFAMANDOLE CEFAZOLIN CEFEPIME CEFME
155. OF TABLES eege Ett et dura achat encens ee See xvii Part I Introduction and Getting Started How TO USE THIS MANUAL scssssssssssesssssesesssesesesssnsnsssusnenscssensuenenenensnsseneneneneneneneneseeaesenes 1 1 Purpose of the VITEK amp 2 Systems Software 1 2 Important Software Features 1 2 Additional Supplies 1 2 Purpose of This Manual 1 3 Intended Audience 1 3 Manual Organization 1 3 How This Manual Is Organized 1 4 Chapter Organization 1 4 Finding Topics and Procedures 1 4 Finding Topics Online 1 5 Typographic and Usage Conventions 1 5 Genus and Species Names 1 5 EEN 1 6 i oceania NE O ME NE E ed 1 6 Commands ido ede eee EE he tee 1 6 Names and TUES yee rasatas med ee Seta A sade nthe 1 6 Press ee ee EE 1 6 Select aiv En heh else SIG Accs AS NS EE 1 6 User Input odori ie ike aka pn Sei eee 1 7 Warnings Cautions and Information 1 7 System Cautions Warnings
156. ON nn 5 3 Figure 5 4 Add Specimen Icon een 5 4 Figure 5 5 Search Inactive Reports ICON urnes 5 7 Figure 5 6 Search Inactive Reports Window ir 5 7 Figure 5 7 Inactive Reports Format Options rene 5 8 Figure 6 1 SRF Workflow Diagram urnes 6 2 Figure 6 2 KR 6 3 Figure 6 3 Copy Biopattern Window nr 6 3 Figure 6 4 View and Maintain SRF Data View ur 6 5 Figure 6 5 Unassociated Biopattern View EE 6 6 Figure 6 6 SRF Organis ii aum 6 7 Figure 6 7 Create SRF Organism ENEE 6 7 Figure 6 8 New SRF Organism Window EEN 6 8 Figure 6 9 Delete ICON ee eni co t ee Figure 6 10 Maintain SRF Organism Association ICON EE Figure 6 11 Maintain SRF Association VIEW Een Figure 6 12 Associate Biopattern SRF Organism Icon ettet Figure 6 13 Maintain SRF Association View EENEG Figure 6 14 Unassociate Biopattern SRF Organism Icon Figure 6 15 Example SRF Organism Report sss Figure 7 1 Cumulative Custom Filter Figure 7 2 QC Audit Report Preview Figure 7 3 Card Details ICOM i p tette ttd Ee 7 6 Figure 7 4 Review Results E 7 7 Figure 7 5 Approve Results ICON urnes 7 8 Figure 7 6 Review Confirmation Window ur 7 9 Figure 7 7 Isolate Groups VIEW see 7 10 Figure 7 8 Record Shipment Icon rennes 7 12 Figure 7 9 Record Shipment Window urnes 7 13 Figure 7 10 Select a Result Report Type ner 7 14 Figure 7 11 QC Laboratory Report rennes 7 15 xii VITEK 2 Systems Software User Manual 510773 3ENI List of Figures Figure 7 12
157. OOS View Link History When you select a link History is selected by default The selected link operation submenu displays the history of the communications tracking data The following transmission information displays Number of the day in the year this is listed first as the Julian date of the year e HH MM SS hour minute second Protocol characters for example lt ENQ gt Data transmitted or received 12 12 VITEK 2 Systems Software User Manual 510773 3ENI Link Operation Configure and Maintain BCI ZB Link Operations COM Manager File Stat Stop T T 4 AE BIS 00S 4 Supervision e Transaction Log Link Operations Blue Upload Green Download LIS1 TheraTrac 59 lt ENQ gt Unused 282 08 59 55 lt ACK gt e Unused 159 55 lt STX gt Ei 9 Link Configuration RS mtrsl iiV2 is123456 itID pi602507 pv0225431896 pnD Usi RS pc pt v10225431896 si sO16 ssBW s5BW s110 14 03 s TheraTrac lt RS gt n ci287264 c016 ct2377 cn2377 talrtGN rr20 tiiloip Unused 59 55 lt RS gt 424202420104240 09100 zz Unused lt GS gt eb Tools lt ACK gt lt ETX gt lt EOT gt lt ENQ gt lt ACK gt lt STX gt RS mtrsl idBMX pii23456 pnJones Mary pli2ADS p2Admis XRS i s01 s110 09 2003 35208 46 3310 09 2003 3408 46 ci RS ure c3P c4Preliminary zz v j gt Refresh Clear LIS1 TheraTrac Unused Unused 600 ooo 000 600 Figure 12 20 Link O
158. Parameter Set Name Date and Time AES Parameter Last Modified NE atest Lab Report Preview Laboratory Report 9 D Se RE re Be Figure 8 22 Laboratory Report First Page of ID Summary VITEK 2 Systems Software User Manual 8 33 510773 3EN1 Printing Result Reports View and Maintain Isolate Results On a Lab Report for each Review and or Approve if electronic signature is disabled the last section of the report contains the following information User ID Action reviewed or approved Date time completed Comment Latest Lab Report Preview bioMerieux Customer 123456789 Laboratory Report Printed Mar 10 2004 08 07 System 987654321 Printed by sjones Patient Name Smith John Patient ID 123456789 Isolate Group 701 2 Bench Wound Selected Organism Staphylococcus aureus 7 Last Mar 7 2004 Parameter NCCLS Natura S Findings Modified 12 36 Set Resistance GLYCOPEPTIDES MSA Action Name User ID Date Time Reviewed by sjones Mar 10 2004 08 07 D Page 2 of 2 E85x11 0in Figure 8 23 Lab Report Page 2 8 34 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Printing Result Reports Accessing and Printing a Detailed Card Report To access a detailed card report 1 From the View and Maintain Isolate Results view select the card level results that you want to view 2 Click on the View Card Details icon 3 The Detailed Card Repo
159. Product Information 4 9 532511 4EN1 NH Quality Control Tables NH Product Information NH Quality Control Tables Campylobacter jejuni ssp jejuni ATCC BAA 1153 Eikenella corrodens ATCC BAA 1152 Gardnerella vaginalis ATCC BAA 1154 Haemophilus aphrophilus ATCC 33389 Haemophilus influenzae ATCC 9007 Neisseria gonorrhoeae ATCC 19424 Neisseria lactamica ATCC 23970 Oligella urethralis ATCC 17960 The organisms below marked with an asterisk indicate additional quality control if required by local regulatory agencies Table 4 5 QC Organism Campylobacter jejuni ssp jejuni ATCC BAA 1153 ArgA PheA v GWG Jesca MTE GGT v Poa dMNE ODC v IGLM v pen PryA dMAL Jara PHOS dGAL sac pve v AdRIB2 LeuA lapa NAG c Jos v ELM v dau URE dw v dxw 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 4 6 QC Organism Eikenella corrodens ATCC BAA 1152 ArgA PheA GWG een me Leer ProA dMNE Joc aM v LysA Pya dma Jann PHOS dGAL SAC PvATE AdRIB2 LeuA APPA NAG Inn jos ELM dau URE dw v dxw 95 to 100 positive v 6 to 94 positive 0 to 5 positive 4 10 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information Table 4 7 QC Organism Gardnerella vaginalis A
160. RODUCTION nitrate to nitrite and FROM NO3 or nitrogen gas NO3 or nitrogen gas from nitrate NO3 gt N2 NaCl 0 GROWTH IN 0 NaCl Ability of certain 4 11 NaCl 6 GROWTH IN 6 NaCl species fo grow In the presence or absence of 6 0 NaCl 0 129 R 0 129 RESISTANCE Ability of certain Some tests also 4 7 species to grow in appear on the GN the presence of the card but are vibriostatic recommended as compound 0 129 supplemental tests since results of conventional macromethods often differ from rapid commercial micromethods ONPG BETA GALACTOSIDASE Presence of beta 4 8 9 11 galactosidase cleaves o nitrophenol beta D galcatopyranoside to produce a yellow colored product Ornith dec Ornithine decarboxylase Hydrolysis of Some tests also 4 6 9 11 17 ornithine releases an appear on the GN amine resulting in card but are alkalinization of the recommended as medium observed supplemental tests with a pH indicator since results of e g purple color conventional formation in the macromethods often presence of differ from rapid bromocresol purple commercial micromethods 069041 4EN1 GN Product Information GN Supplemental Tests Table 1 13 GN Supplemental Tests Abbreviation Test Name Description Comments Reference OX OXIDASE Detection of the Characteristic useful 6 8 9 10 11 presence of in identifying many 15 17 cytochrome C species of non fermenters All members of En
161. RTANT Global Forcing Rules will force the category call only not the MIC Rule 1 For speciated CNS other than Staphylococcus epidermidis and Staphylococcus lugdunensis if the cefoxitin screen test OXSF is negative and the oxacillin OXT MIC is 0 5 1 or 2 the oxacillin MIC interpretation is forced susceptible A note is included when a KeylD of coagulase negative staphylococci is used i e not speciated indicating that inappropriate oxacillin breakpoints may be applied Note Final oxacillin interpretation after AES expertization is also dependant on the recognized B lactam phenotype VITEK 2 Systems Software User Manual B 5 510773 3EN1 Appendix B Forcing Rules Rule 2 If Candida krusei is tested then the results are forced resistant for the following antifungals Fluconazole CA SFM Forcing Rules IMPORTANT CA SFM Forcing Rules will force the category call only not the MIC Rule 1 If Candida krusei is tested then the results are forced resistant for the following antifungals Fluconazole B 6 VITEK 2 Systems Software User Manual 510773 3ENI APPENDIX C AES ANTIBIOTIC DEDUCTION RULES Introduction This Appendix contains the deduction rules for AES AES Antibiotic Deduction Rules SELECTION CRITERIA ANTIBIOTICS All SPECIES All INTERPRETATION GUIDELINES All ACTIVITY STATE All RULE 1 INTERPRETATION GUIDELINES PHENOTYPIC Active If Staphylococcus And One of the
162. Reactions must follow Product Information results If the results do not meet the criteria subculture for purity and repeat the test If discrepant results are repeated perform an alternate identification method Testing and Storage of QC Organisms Rehydrate organism per the manufacturer s instructions Fastidious Use Chocolate agar and incubate at 35 C to 37 C in 5 to10 CO3 Incubate for 18 to 24 hours or until sufficient growth is obtained Campylobacter Use Trypticase Soy with 596 sheep blood agar and incubate 35 C to 37 C in microaerophilic conditions for 18 to 24 hours or until sufficient growth is obtained Check for purity Perform second subculture for testing 4 8 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information Quality Control Storage Conditions Short Term Storage Short term storage is not recommended Cultures maintained by other methods specifically those maintained on agar plates or slants for long periods of time at room temperature or at 2 8 C are subject to loss or change of important biochemical characteristics Long Term Storage 1 Make a heavy suspension in Tryptic Soy Broth TSB with 15 glycerol 2 Freeze at 70 C 3 Subculture twice before running QC Note Avoid repeated thawing and refreezing by either freezing in single use aliquots or removing a small portion of frozen organism preparation with a sterile applicator stick VITEK 2 Systems
163. Storage For long term storage copy the CD RW contents to a network drive or to a tape drive 14 2 VITEK 2 Systems Software User Manual 510773 3ENI Data Backup and Daily Maintenance Backup Isolate Data Automatic Backup CD Failure Note The system software can be set up to initiate nightly backup When automatic backup is enabled or when a laboratory technologist initiates a backup the system software will fail if any of the following items are found CD contains isolate report archive CD contains export data CD is damaged reliability for data storage If any of these conditions exist the system software logs the backup failure and notes the reason for failure If none of these conditions are present the system software performs the backup The automatic backup will overwrite any previous data backup on the inserted CD If the CD fails during an unattended backup the system software logs the backup failure and notes the reason for failure This information can be considered an unacknowledged system software alarm and is displayed to the next user to log in An automatic or unattended backup failure is logged in the alarm history If the backup was initiated by a laboratory technologist the system software informs the laboratory technologist that backup failed and the message notes the reason for failure Laboratory Technologist Initiated Isolate Data Backup VITEK 2 Systems Software User Manual 14 3 5
164. Streptococcus agalactiae And One of the following antibiotics has been tested AMPICILLIN BENZYLPENICILLIN Then The result can be reported for AMPICILLIN BENZYLPENICILLIN ED VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules RULE 45 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus agalactiae And One of the following antibiotics has been tested CEFEPIME CEFOTAXIME CEFTRIAXONE Then The result can be reported for CEFEPIME CEFOTAXIME CEFTRIAXONE RULE 46 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus agalactiae And One of the following antibiotics has been tested BENZYLPENICILLIN And The result is S Then The result can be reported for AMOXICILLIN AMOXICILLIN CLAVULANIC ACID AMPICILLIN AMPICILLIN SULBACTAM CEFACLOR CEFALOTIN CEFAZOLIN CEFDINIR CEFEPIME CEFOTAXIME CEFPODOXIME CEFPROZIL CEFRADINE CEFTIZOXIME CEFTRIAXONE CEFUROXIME CEPHAPIRIN ERTAPENEM VITEK 2 Systems Software User Manual C 13 510773 3EN1 Appendix C AES Antibiotic Deduction Rules IMIPENEM LORACARBEF MEROPENEM RULE 47 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus agalactiae And One of the following antibiotics has been tested ERYTHROMYCIN Then The result can be reported for AZITHROMYCIN CLARITHROMYCIN DIRITHROMY
165. Subculture organism to be tested to an appropriate agar medium and incubate accordingly Note Prepare the inoculum from a pure culture according to good laboratory practices In case of mixed cultures a re isolation step is required A purity check plate is recommended to ensure that a pure culture was used for testing 2 Aseptically transfer 3 0 mL of sterile saline 0 45 to 0 5 NaCl pH 4 5 to 7 0 into a clear plastic polystyrene test tube 12 x 75 mm 3 Use a sterile stick or swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in step 2 Prepare the homogenous organism suspension with a density equivalent to the appropriate McFarland No see the Culture Requirements Table on page 6 6 using a calibrated DENSICHEK 4 Ina second tube containing 3 0 mL of saline transfer 145 uL of the adjusted suspension prepared in step 3 for AST GN cards or 280 uL of the adjusted suspension for AST GP or AST YS cards Note Age of suspension must not exceed 30 minutes before inoculating card 5 Place the dilution tube prepared in step 4 and AST card in the cassette 6 Referto the user manual for instructions on data entry and how to load the cassette into the instrument 7 Follow the local inspecting agency s guidelines for disposal of hazardous waste Quality Control QC organisms and their expected results can be found in the package insert and should be processed according to
166. Systems Product Information 069045 2EN1 SUSCEPTIBILITY PRODUCT INFORMATION Intended Use The Antimicrobial Susceptibility Test AST card is intended for use with VITEK 2 systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram negative bacilli Staphylococcus spp Enterococcus spp Streptococcus agalactiae S pneumoniae and yeast Summary and Explanation of the Test Susceptibility testing is indicated for any organism that contributes to an infectious process warranting antimicrobial chemotherapy Susceptibility tests are most often indicated when the causative organism is thought to belong to a species capable of exhibiting resistance to commonly used agents Isolated colonies of an organism that may play a pathogenic role are selected from an agar plate and tested for susceptibility These tests are then examined and the Minimum Inhibitory Concentration MIC is determined The MIC obtained using a dilution test may tell the physician the concentration of an antimicrobial agent needed at the site of infection to inhibit the infecting organism MICs have been determined traditionally using antimicrobial concentrations derived from serial twofold dilutions 5 The MIC is then determined from the lowest dilution that shows inhibition of growth Interpretative criterion Susceptible Intermediate or Resistant can then be assigned to MIC res
167. Systems Software User Manual 6 1 510773 3EN1 3 Activating SRF Organisms Maintain Supplemental React File Industrial Use 7 The system software is updated and the biopattern is no longer with the SRF Organism View SRF Biopattern Associations for an Existing SRF Organism 1 Select SRF organism displayed in the list 2 The associated SRF biopatterns are listed under the organism name in the navigation tree The following information displays in the navigation tree Accession Bionumber read only 3 The following information displays in the workspace Status SRF Organism Code SRF Organism Name Card Type Comment 4 Selecting a displayed bionumber displays the SRF Biopattern Details Activating SRF Organisms You can activate SRF organisms when the organism reaches the minimum number of associated SRF biopatterns The minimum number of associated biopatterns is 10 To activate the SRF organism 1 Select the SRF Organism in the displayed list 2 If there are 10 or more biopatterns associated to the selected SRF organism the Status drop down list is no longer grayed out and you can elect to activate the SRF organism to make the organism available for ID analysis 3 Select the SRF Organism and select Active from the Status drop down list This makes the SRF organism available for ID analysis Note If the SRF organism has not met the minimum number of associated SRF biopatterns you cannot change th
168. T v GIyA IMLTa x BGAL dMAL TyrA v 5KG ODC ELLM H2S dMAN URE ILATk v LDC ILATa ES BNAG v dMNE dSOR AGLU v IHISa 95 to 100 positive v 6 to 94 positive 0 to 5 positive VITEK 2 Systems Product Information 1 13 069041 4EN1 Limitations Limitations GN Product Information The VITEK 2 GN card cannot be used with direct clinical samples or other sources containing mixed flora Any change or modification in the procedure may affect the results Newly described or rare species may not be included in the GN database Selected species will be added as strains become available Testing of unclaimed species may result in an unidentified result or a misidentification Performance Characteristics In a recent multi site clinical study the performance of the VITEK 2 GN was evaluated using 562 clinical and stock isolates of both commonly and rarely observed species of gram negative bacilli including 153 non fermentative strains The reference identification was determined with api 20 E and api 20 NE identification kits Overall the VITEK 2 GN correctly identified 96 8 of the isolates including 6 4 low discrimination with the correct species listed Misidentifications occurred at 3 0 and no identifications occurred at 0 2 Organisms Identified by the GN Card Enterobacteriaceae e Buttiauxella agrestis Cedecea davisae Cedecea lapagei e
169. TATE alkalinisation ILATk 0 15 mg 41 ALPHA GLUCOSIDASE AGLU 0 036 mg 42 SUCCINATE alkalinisation SUCT 0 15 mg 43 Beta N ACETYL GALACTOSAMINIDASE NAGA 0 0306 mg 44 ALPHA GALACTOSIDASE AGAL 0 036 mg 45 PHOSPHATASE PHOS 0 0504 mg 46 Glycine ARYLAMIDASE GlyA 0 012 mg 47 ORNITHINE DECARBOXYLASE ODC 0 3 mg 48 LYSINE DECARBOXYLASE LDC 0 15 mg 52 DECARBOXYLASE BASE ODEC NA 53 L HISTIDINE assimilation IHISa 0 087 mg 56 COURMARATE CMT 0 126 mg 57 BETA GLUCORONIDASE BGUR 0 0378 mg 58 O 129 RESISTANCE comp vibrio O129R 0 0105 mg 59 Glu Gly Arg ARYLAMIDASE GGAA 0 0576 mg 61 L MALATE assimilation IMLTa 0 042 mg 62 ELLMAN ELLM 0 05 mg 64 L LACTATE assimilation ILATa 0 186 mg Note Other well numbers between 1 and 64 not designated in this table are empty VITEK 2 Systems Product Information 1 19 069041 4EN1 GN Supplemental Tests GN Supplemental Tests GN Product Information Table 1 13 GN Supplemental Tests Abbreviation Test Name Description Comments Reference 41C GROWTH AT 41 C Ability of certain 10 species to grow at 41 C 42C GROWTH AT 42 C Ability of certain 11 species to grow at 42 C ADONITOL ADONITOL acidification Acidification of Some tests also 4 6 8 9 11 dCELLOB D CELLOBIOSE acidification Carbon source appear on the GN 12 17 AMALTOSE DMALTOSE acidificati observed with pH card but are SE z OSE acidification indicator e g recommended as
170. TAZOLE CEFONICID CEFOPERAZONE CEFOTAXIME CEFPODOXIME CEFRADINE CEFTAZIDIME CEFTIZOXIME CEFTRIAXONE CEFUROXIME CEFUROXIME AXETIL CEPHAMYCINS CLOXACILLIN DICLOXACILLIN LATAMOXEF LORACARBEF METHICILLIN NAFCILLIN PENEMS PIPERACILLIN TAZOBACTAM VITEK 2 Systems Software User Manual C 9 510773 3EN1 Appendix C AES Antibiotic Deduction Rules TICARCILLIN CLAVULANIC ACID RULE 35 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Staphylococcus And One of the following antibiotics has been tested OXACILLIN MIC OXACILLIN And The result is R Then The result can be reported for BETA LACTAMS RULE 38 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus pneumoniae And One of the following antibiotics has been tested AMOXICILLIN AMOXICILLIN CLAVULANIC ACID Then The result can be reported for AMOXICILLIN AMOXICILLIN CLAVULANIC ACID RULE 39 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus pneumoniae And One of the following antibiotics has been tested CEFOTAXIME CEFTRIAXONE Then The result can be reported for CEFOTAXIME CEFTRIAXONE Cio VITEK 2 Systems Software User Manual 510773 3ENI Appendix C AES Antibiotic Deduction Rules RULE 40 INTERPRETATION GUIDELINES NATURAL RESISTANCE Active CLSI M100 S15 2005 Active If Streptococcus pneumoniae
171. TCC BAA 1154 NH Quality Control Tables ArgA v PheA v GLYG BGALi V MTE v GGT ProA dMNE v ODC v IGLM LysA v PryA dMAL v AARA v PHOS dGAL v TyrA v SAC v PVATE v dRIB2 v LeuA GR APPA NAG PHC OPS ELLM v dGLU V URE dMLT V dXYL v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 4 8 OC Organism Haemophilus aphrophilus ATCC 33389 ArgA PheA GLYG BGALI MTE GGT v ProA dMNE ODC S IGLM LysA v PryA dMAL v AARA PHOS dGAL v TyrA v SAC PVATE dRIB2 v LeuA APPA nagi V PHC v OPS v ELLM dGLU URE dMLT t dXYL 95 to 100 positive v 6 to 94 positive 0 to 5 positive Haemophilus aphrophilus reaction for NAG is usually positive however it is rare but possible that a negative reaction will occur Table 4 9 Recommended QC Organism Haemophilus influenzae ATCC 9007 ArgA v PheA GLYG BGALi MTE GGT ProA dMNE ODC IGLM LysA v PryA az dMAL AARA PHOS dGAL TyrA v SAC PVATE dRIB2 LeuA APPA NAG v PHC OPS ELLM dGLU URE dMLT dXYL 95 to 100 positive v 6 to 94 positive 0 to 5 positive VITEK 2 Systems Product Information 532511 4EN1 NH Quality Control Tables NH Product Information Table 4 10 QC Organism Neisseria gonorrhoeae ATCC 19424 laga v
172. The system software is a component used to support the VITEK 2 instruments Susceptibility and identification tests performed using the system software are intended for use by clinicians for therapeutic guidance Additionally results obtained from identification tests are used for environmental monitoring and quality control purposes in an industry context This software user manual describes using the system software to obtain results from the susceptibility tests and identification tests This manual describes how to use the system software application to perform diagnostic tests using VITEK 2 instruments This chapter highlights the new features offered with the workstation software and describes finding help using this software user manual and other technical resources Important Software Features New features include The VITEK 2 Systems software runs in a PC environment Easy to use system software interface Advanced Expert System AES for Clinical Use provides therapeutic guidance for advanced analysis of results and the detection of phenotypes Identification for Industry Use allows labs to copy and maintain specific biopattern information for organisms in a Supplemental React File SRF 21 CFR 11 compliance mode provides the ability to version changes on a laboratory report archive isolates and audit history to a CD and prevents deletion of cards Additional Supplies Contact bioM rieux or your l
173. UPULJOJJOd JUHA ds JEIGOHIUHUW Z AILA T 9 9 qer VITEK 2 Systems Product Information 6 18 510774 3EN1 Performance Characteristics Susceptibility Product Information Ba o m o o o o I o o M ejozexoujeuiejIns Zuudousuut uuudousuut up uupigoL o 1n N E E 9 G NIKI We mim E ci St S ol olo et z S u w 13y A1039 e5 ASV oAneSoN WeLID JOJ sonsuojeleu e ueuuojlod naje M o ola o nje m ajo n ala Sals st le z Le Ir Il Z 10413 A KEE RSC bz go gd din a a o ojojo ka wi u w 1Sy Jenuoess3 ploy iue nae DOL ZUM DAP2IL DOL eu1pA8811 DIL ui D4e nr eweN uouiuo jeiqox iumuy 1SV 9 njeSoN Wes 10 sorsuopereu D2UPULJOJJOd JUHA ds jerqorirumuy Z AILA T 9 9 qer 6 19 VITEK 2 Systems Product Information 510774 3EN1 Susceptibility Product Information Performance Characteristics ejqeoidde JON Y N e qeje e JON ejep vuewop d eulaju ejep o9UeUJOJJad eulejx3 3 Daigop 4 0LG uonensiunupy BNIJ pue poo SN hey Ue Peg0 9U W JOJ OJaUIDY pue DSoU HnJaD spuouiopnasd uet 1430 seneds 104 sieyjo DsouiBnJoD spuowopnasg 10 Dnuan 4 se pojeu isop ase sdnoiJ8 wusiue310 2ijpads juaw Ayjigonpoidai odday nsai 92u219j21 JUe SISA JO ajqudadsns UJM 3 nsaJ 9jerpauuJejui ue JO jjnsa1 92ua19j9J DJEIPOUIJOJU ue YPM 3 nsa1 JUPJSISOI JO e qndeosns 10418 jour FW nsa 92ua
174. VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Modifying Isolate Groups and Test Cards Changing Additional Information and Organism Quantity To modify information associated with isolate results at the isolate level 1 Select an isolate group or an individual test card Note f21 CFR 11 is enabled any change made to an isolate group creates a new version of the isolate lab report and indicates a change was made after final call 2 Select the button labeled to view additional information Patient Name Zhicheng Bohra spo Lab ID 361 1 B Organism Staph aureus 91 096 v Review Status To be reviewed Report Version D Bionumber 0020005006372224 ID Confidence Good identification Analysis Status 2 hr Final Cal Figure 8 9 Additional Information Button 3 The Additional Isolate Information window appears MM additional Isolate Information Additional Isolate Information Organism Quantity 20 Bench Blood E Setup Tech y Bionumber 0020005006372224 Contraindicating Tests dTRE 0 8674102 NOVO 0 56225185 dX YL 0 66225165 Supplemental Tests Figure 8 10 Additional Isolate Information Window 4 Enter or select a new Organism Quantity and make any necessary changes 5 Enter or select a new Bench Name and make any necessary changes VITEK 2 Systems Software User Manual 8 15 510773 3EN1 Modifying Isolate Groups and T
175. Well Contents GN Product Information GN Well Contents Table 1 12 GN Well Contents Well Test Mnemonic Amount Well 2 Ala Phe Pro ARYLAMIDASE APPA 0 0384 mg 3 ADONITOL ADO 0 1875 mg 4 L Pyrrolydonyl ARYLAMIDASE PyrA 0 018 mg 5 L ARABITOL IARL 0 3 mg 7 D CELLOBIOSE dCEL 0 3 mg 9 BETA GALACTOSIDASE BGAL 0 036 mg 10 H2S PRODUCTION H2S 0 0024 mg 11 BETA N ACETYL GLUCOSAMINIDASE BNAG 0 0408 mg 12 Glutamyl Arylamidase pNA AGLTp 0 0324 mg 13 D GLUCOSE dGLU 0 5 mg 14 GAMMA GLUTAMYL TRANSFERASE GGT 0 0228 mg 15 FERMENTATION GLUCOSE OFF 0 45 mg 17 BETA GLUCOSIDASE BGLU 0 036 mg 18 D MALTOSE dMAL 0 3 mg 19 D MANNITOL dMAN 0 1875 mg 20 D MANNOSE dMNE 0 3 mg 21 BETA XYLOSIDASE BXYL 0 0324 mg 22 BETA Alanine arylamidase pNA BAlap 0 0174 mg 23 L Proline ARYLAMIDASE ProA 0 0234 mg 26 LIPASE LIP 0 0192 mg 27 PALATINOSE PLE 0 3 mg 29 Tyrosine ARYLAMIDASE TyrA 0 0276 mg 31 UREASE URE 0 15 mg 32 D SORBITOL dSOR 0 1875 mg 33 SACCHAROSE SUCROSE SAC 0 3 mg 34 D TAGATOSE dTAG 0 3 mg 35 D TREHALOSE dTRE 0 3 mg 36 CITRATE SODIUM CIT 0 054 mg 37 MALONATE MNT 0 15 mg 39 5 KETO D GLUCONATE 5KG 0 3 mg Lg VITEK 2 Systems Product Information 069041 4EN1 GN Product Information GN Well Contents Table 1 12 GN Well Contents Well Test Mnemonic Amount Well 40 L LAC
176. WoC Cumulative Report Cus istomer ID QC Cumulative Report Printed by RenSuper System 10189761 Printed Oct 15 2003 1072 Cant Type Et 1 Nue bar 10120040 Card Rape Date Nov 29 2000 EES EC organ Esencon ze Tauck Boat JETI EISE EI E E Ez EH EEN 28 Eu ER D Page 1 of 1 ma5xitin Figure 7 13 QC Cumulative Report ITEK 2 Systems Software User Manual VI m 7 17 510773 3EN1 Printing QC Laboratory Reports Maintain Customer Quality Control 7 18 VITEK 2 Systems Software User Manual 510773 3ENI PART III VIEW AND MAINTAIN RESULTS ALS Findings Phenotypes Selected for Review OHOn Aug 11 2009 Y 341 1 Borgeyela zocheicum v 421 Chrome violsceum D 960 1 csset gat v 391 1 Stach aureus y 370 1 Crypto uriguttulatus VITEK 2 technology VIEW AND MAINTAIN ISOLATE RESULTS 8 About This Chapter This chapter describes viewing maintaining reviewing and approving any information associated with isolate results Chapter Contents Access the Isolate Results View 8 3 Using the Navigation Tree to View Specific Isolate Results 8 5 Active Workspace versus Inactive Workspace 8 5 Expanding and Collapsing the Navigation Tree 8 6 Search by Accession Number 8 7 Status Icons and Descriptions 8 7 Qualified Isolates 8 9 Using the Right View Bar to View Specific Results 8 9
177. XS This test predicts either a susceptible or resistant result for oxacillin when tested for Staphylococcus species The test result correlates with results obtained from the agar screen method Cefoxitin Screen OXSF This test may be used to predict mecA mediated oxacillin resistance and it is based on the cefoxitin disk screen test The cefoxitin screen and oxacillin work in combination to determine the final interpretation reported for oxacillin Most methicillin resistant staphylococci MRS are usually also resistant to multiple antibiotics including other beta lactams aminoglycosides macrolides clindamycin and tetracycline Synergy Screen Since the use of penicillin or ampicillin alone often results in frequent failure in the treatment of serious enterococcal endocarditis combination therapy is usually indicated to enhance bactericidal activity The 6 2 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Principle of the Procedure synergy between a cell wall active agent such as penicillin ampicillin or vancomycin and an aminoglycoside such as gentamicin kanamycin or streptomycin is best predicted for enterococci by screening for high level resistance to the aminoglycoside When enterococci are susceptible in vitro to the high level aminoglycoside and a cell wall active agent this is predictive of the effectiveness of this combination therapy The VITEK 2 systems results are
178. YCOPEPTICES RESISTANT VAN A LKE RESISTANT VAN DURE v BN HUE e B 1131 osuetan 201 1 Fach cok v 2024 rte seen Bag Mire Mtroturarton 1200 R 303 1 Esch cel Roch y 204 1 Ps neraznosa Tetracycine 180 D o E ov 2051 otro revni D v 206 1 Soh aureus v 207 1 Ertero aum Y 2051 Str pruxumcrine T 209 1 Comguinte neg Stach BR 201 1 K oxytoce Figure 8 13 View AST Card Results T3333 Vancomycr Arche Erythromyon egen Heh Level syne Levoftoxecn Benz verc Nortoxacin regen High Level ey S VITEK 2 technology VITEK 2 Systems Software User Manual 8 19 510773 3EN1 AST Card Details View and Maintain Isolate Results 2 The following four sections appear in the detailed antibiotic results area of the active workspace Report When the check box beside the Antibiotic is not selected the antibiotic appears on all reports When the antibiotic is selected the antibiotic does not appear on the Chart Report and is not sent to the LIS For details see Report Selected Antibiotics on page 8 21 Antibiotic Name of the antibiotic on the AST card MIC Value A routine susceptibility test value used to represent the minimum inhibitory concentration of antimicrobial agents MIC values are measured in micrograms per milliliter ug mL The following may appear in the MIC column for tests these cannot be changed TABLE 8 4 MI
179. a message appears 8 When archive is complete a reference number is automatically assigned to the CD A supervisor can use this reference number to locate the isolate reports for inspection 9 When the archive is complete an index is created on the CD to allow the Supervisor to easily find specific isolate reports Note Be sure to label the archive CD to easily find specific archived isolate reports 13 10 VITEK 2 Systems Software User Manual 510773 3ENI System Utilities Archive Isolates Too Many Isolate Reports for One CD If there are too many Isolate Reports for one CD a message appears letting you know that there is not enough space on the CD for all of the Isolate Reports The system software displays an approximate number of CD Rs needed to complete archive When the first CD is full the system software will prompt you to remove the CD and insert another one until archive is complete Viewing and Searching Archived Isolate Reports As a Supervisor you can view the following items Archived Isolate Reports Archived Isolate Audit Archived Application Audit Previous Version of Isolate Reports Note Only a Supervisor can view archived isolate reports from an archive CD 1 From within the Main view select Utilities view gt Archive and View Archived Reports to view the most recent version of the Isolate Reports 2 Archived Application Audit can be viewed using the Search Audit Trail function 3 To fi
180. a eerte es bague er peer DUE 8 37 Delet Icon aids onto i er DR ER RD V ERR ie 8 37 Delete Card Message inner 8 38 Eject Card ICON i ge trate icut enn ute lle A 8 38 Eject Card Message AE 8 39 Reanalyze Results retener ttt tnter tereti tato 8 39 Review Results ste nt ree lee dette aieo res 8 40 VITEK 2 Systems Software User Manual 510773 3EN1 xiii List of Figures Figure 8 33 Batch Review ur 8 4 Figure 8 34 Approve Results EEN 8 42 Figure 8 35 Batch Approve ENEE 8 42 Figure 9 1 Configure ID Analysis 9 2 Figure 9 2 AST Configuration View nr 9 4 Figure 9 3 Result Validation Configuration nn 9 8 Figure 10 1 Configuration ICON EEN 10 2 Figure 10 2 Configuratlon Drop Down MENU EE 10 5 Figure 10 3 Unlock Configuration view nn 10 3 Figure 10 4 Save Icon ere 10 4 Figure 10 5 Cancel Changes ICOM ee 10 4 Figure 10 6 General Configuration View EEN 10 5 Figure 10 7 System Information urnes 10 6 Figure 10 87 System Mode 32 nn Eed EE 10 7 Figure 10 9 Print Settings 10 8 Figure 10 10 Miscellaneous Settings EEN 10 9 Figure 10 11 Version VieW Een 10 11 Figure 11 1 Configuration Drop Down Menu with AES Configuration Selected 11 2 Figure 11 2 AES Configuration View 11 3 Figure 11 3 AES Configuration Warning uen 11 4 Figure 11 4 AES Configuration View ire 11 6 Figure 11 5 AES Active Parameter Set nn 11 8 Figure 11 6 Activate Parameter Set Confirm
181. a specific shipment 7 Thefollowing QC information associated with the selected card appears Expected organism for AST cards and Workstation Key ID Organism 8 When all information is entered and associated click OK 9 The Set Up QC Test window closes and the cassette display updates Note QC Isolate groups contain only one card either an AST or an ID card For details on managing QC results see Chapter 7 Maintain Customer Quality Control VITEK 2 Systems Software User Manual 4 25 510773 3EN1 Setting Up and Entering Quality Control QC Information Set Up Test Cards and Cassette Information 4 26 VITEK 2 Systems Software User Manual 510773 3EN1 MANAGE PATIENT INFORMATION CLINICAL USE About This Chapter This chapter describes viewing managing and linking patient and specimen information Chapter Contents Viewing and Filtering Patient and Specimen Information 5 2 Adding Patients 5 3 Adding Specimens 5 4 Linking Isolate and Patient Information 5 4 Linking Specimens to an Existing Isolate 5 5 Creating a Specimen Before an Isolate Exists 5 5 Data Management Download 5 6 Deleting Specimens 5 6 Moving Specimens 5 6 Searching Inactive Reports 5 6 Printing Reports 5 8 VITEK 2 Systems Software User Manual 5 1 510773 3EN1 Viewing and Filtering Patient and Specimen Information Manage Patient Information Clinical Use Viewing and Filtering Patient and Specimen Information
182. aa a New Therapeutic Interpretation Select an Organism Zeng Pseudomonas group z bei nd Gram positive cocci Figure 11 21 Select One or More Organism 3 Select one or more organisms and click the Arrow icon to include it When you have finished making the organism selection click Next 4 Double click to expand organism choices Note Only one selection is allowed 5 Select the antibiotic and click the Arrow icon to include it Click Next when you have made your selections 6 Select a phenotype and click the Arrow icon to include it Click OK when you have made you selection 7 The new therapeutic interpretation appears in the workspace area Delete Therapeutic Interpretations 1 Select the Therapeutic Interpretations that you want to delete 2 Click Delete zoo o e S JJJ VITEK 2 Systems Software User Manual 11 21 510773 3EN1 Printing User Change Report 1 Printing User Change Report View and Configure AES 1 22 Print the User Changes Report to review every variance in all existing custom parameter sets or guidelines For every change to a predefined parameter set the custom parameter set value appears in the table on the report The user change report Compares the custom parameter set with the predefined parameter set used as a basis Contains all differences between the custom parameter set and the predefined parameter set To generate a User Change R
183. ab tech 10 4 save cancel changes 10 4 supervisor rights 2 5 10 4 system mode parameters 10 6 unlock lock 10 3 Configuration Views access 10 2 Configure AST Analysis 9 3 Configure ID Analysis enable SRF analysis 9 2 select organisms for automatic slashline 9 2 set time to eject analyzed cards 9 2 Connection error status 12 21 OK status 12 21 warning status 12 21 Connection Interface global status information download 12 5 host 12 5 link name 12 4 status 12 4 upload 12 4 Contraindicating Tests 8 15 Conventions typographic 1 5 usage 1 5 Copy Biopattern to SRF isolate group results status is final 6 3 procedure 8 29 Copy Biopattern Window 6 3 Critical Isolates 9 6 Cumulative QC Search Criteria Window 7 4 Cumulative Results create view 7 10 Current BCI Alarm Report 12 24 Current BCI Alarms 12 22 Custom Filter for QC Results 7 4 Customer Quality Control maintaining 7 1 Deduced Antibiotics highlighted on report 8 51 Delete 8 56 Delete SRF Organism 6 5 Delete Virtual Cassette 4 19 Detailed AES Report 8 23 Display Inactive Reports 5 8 Eject Cards 8 37 Electronic Signature approve isolate 8 40 information about 7 9 information on lab report if disabled 8 33 if enabled 8 31 review results 8 39 review approve QC results 7 8 7 9 Enable SRF Analysis 9 2 9 3 End of Day Processing alarm management cleanup 14 5 cassette management cleanup 14 5 deleted isolates cleanup 14 5 instrument status management clean
184. able 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 VITEK 2 Systems Product Information 532501 3EN1 Symbols Standard Symbols CONTROL OFF Only for a Component of the System Equipment Equipment Protected Throughout by Double Insulation or Reinforced Insulation Equivalent to Class Il of IEC 536 Very Toxic Corrosive Sodium Azide Irritant Positive Control Negative Control Keep Away From Sunlight Protect From Light Symbols VITEK 2 Systems Product Information 532501 3ENI Standard Symbols gt x e K This Way Up Do Not Stack Humidity Limitations Separate Collection for Waste Electrical and Electronic Equipment VITEK 2 Systems Product Information 532501 3EN1 Symbols TABLE OF CONTENTS GN PRODUCT INFORMATION 2 0 0 0 cess cess ence eee eee 1 1 Intended Use 1 1 Description ENEE EENS Eee rk that dna 1 1 Precautions c esae pe VE EA dates 1 1 Storage and Handling 1 2 Specimen Preparation 1 2 Materials de eis annuaire he meee 1 3 Procedure
185. abouraud Dextrose Agar w Gentamicin and Chloramphenicol TSA Trypticase Soy Agar TSAB Trypticase soy agar with 5 sheep blood VITEK 2 Systems Product Information 510774 3EN1 6 7 Procedure Susceptibility Product Information TSAHB Trypticase Soy Agar w Horse Blood Procedure Materials When used with VITEK 2 instrumentation the AST card is a complete system for routine susceptibility testing Materials required are VITEK 2 AST Card VITEK 2 DENSICHEK DENSICHEK Power Adapter Lithium Battery of DENSICHEK DENSICHEK Calibrator VITEK 2 Compact Cassette Sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 12 x 75 mm clear plastic polystyrene disposable test tubes Sterile sticks or swabs Appropriate agar medium See Culture Requirements Table on page 6 6 Micropipettes to deliver 145 uL and 280 pL Disposable pipette tips Optional accessories Saline dispenser Predispensed saline test tubes aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 Test tube caps Vortex 6 8 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Quality Control Test Card Setup Procedure The following procedure contains general information applicable to all susceptibility products See the Culture Requirements Table on page 6 6 for product specific information 1 Select isolated colonies from a primary plate if culture requirements are met or
186. aenibacillus polymyxa Paenibacillus pabuli Paenibacillus polymyxa VITEK 2 Systems Product Information 069045 2EN1 5 5 Results BCL Product Information Identification Card Qualifying Messages Table 5 3 Identification Card Qualifying Messages ID Message TT Sopra Choices Probability Comments Confidence Level Excellent 1 96 to 99 Very Good 1 93 to 95 Good 1 89 to 92 Acceptable 1 85 to 88 Low Discrimination 2to3 Sum of choices 100 2 to 3 taxa exhibit same after resolution to one biopattern choice percent Separate by probability reflects the supplemental testing number associated with selected choice Unidentified gt 3 n a Either gt 3 taxa exhibit Organism same biopattern or or 0 Very atypical biopattern Does not correspond to any taxon in the database Check Gram stain and purity Percent Probability As part of the identification process the software compares the test set of reactions to the expected set of reactions of each organism or organism group that can be identified by the product A quantitative value the percent probability is calculated and relates to how well the observed reactions compare to the typical reactions of each organism A perfect match between the test reaction pattern and the unique reaction pattern of a single organism or organism group would provide a percent probability of 99 When a perfect match is not obtained
187. age appears requiring that you enter the correct information if the parameter set name already exists or if the name is left blank The selected parameter set MCCLS Watural Resistance will be used as the basis for the new custom parameter set Please enter a parameter set name and description Namen Grart Medical Carter 1 51 noir Resistance Description C31 cadere arci Natural Resistance rterpretaions VITEK 2 technology Figure 11 8 Create a Custom Parameter Set 4 Click OK to create a copy of the predefined parameter set 5 The custom parameter set appears in the navigation tree 11 10 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Note Viewing MIC Interpretation Guideline Only custom parameter sets can be modified 6 The new parameter set is already selected when it is created Deleting Custom Parameter Sets Note Only custom parameter sets can be deleted However a custom parameter set cannot be deleted if it is the active parameter set Deleting a custom parameter set also deletes the associated custom interpretation guidelines as long as there are no other parameter sets referenced by the custom interpretation guideline To delete a parameter set follow these steps 1 Select the parameter set you want to delete 2 Click Delete 3 If this parameter set can be deleted you will need to confirm deletion of this parameter set and its associated MIC and The
188. ailed Card Report ID and AST Details 8 35 Sending Data to LIS 8 36 Deleting Cards or Isolate Groups 8 37 Ejecting Cards sums Fawn ie due den eae RED UE TUIS 8 38 Reanalyzing Isolate Results 8 39 Review and Approve Results Configuration 8 40 Reviewing Results 8 40 Reviewing Batch Results 8 40 Approving Results 8 41 Approving Batch Results 8 42 CONFIGURE RESULTS ANALYSIS AND REVIEW mmnnununnunnnannnnnununennnnnanennnanennennnnnneune 9 1 Configuring ID Analysis 9 2 View and Maintain ID Analysis 9 2 Selecting Organisms for Automatic Slashline 9 3 Enabling SRF Analysis Industry Use 9 3 Setting the Time to Eject Analyzed Cards 9 3 Configuring AST Analysis 9 3 Accessing AST Analysis Configuration 9 4 Card EjOCHOR soci may un DRE ead Ban She Ws Bal ERU SES 9 4 Deducing Antibiotics 9 4 Suppressing Antibiotics
189. ake it to the VITEK 2 instrument For systems using a Smart Carrier Station each cassette is fitted with a special memory chip called the button memory When a cassette is on a Smart Carrier Station the button memory stores the information that you enter for each test card This information is read by a station in a VITEK 2 instrument which marks the memory chip as being read allowing the cassette to be reused 8 Place the cassette into the Cassette Load station and close the door The VITEK 2 instrument scans the card bar codes to detect any problems expired cards card type that could not be determined etc VITEK 2 Systems Software User Manual 4 21 510773 3EN1 Using the Smart Carrier Station SCS Set Up Test Cards and Cassette Information Smart Carrier Cassette Information Note Once a Smart Carrier Station cassette has been read by a VITEK 2 instrument and isolate and the cassette definition have been transferred to the workstation you can process and manage that cassette with the VITEK 2 Systems software The VITEK 2 instrument sends the cassette definition including isolate information to the workstation A reconciled SCS cassette transferred to the workstation will include the following Cassette ID SCS Bench Name if enabled in configuration SCS Setup Tech User ID Accession ID Card Bar Code A cassette appears in red in the navigation tree when additional information is needed to c
190. al methods 1 3 6 and newly developed substrates There are 46 biochemical tests measuring carbon source utilization nitrogen source utilization and enzymatic activities Final results are available in approximately 18 hours For a list of well contents see YST Well Contents on page 3 16 Precautions For In Vitro Diagnostic Use Only Suspensions not within the appropriate zone on the VITEK 2 DENSICHEK may compromise card performance Do not use the card after the expiration date shown on the package liner Store the card unopened in the package liner Do not use the card if the protective package liner is damaged or if no desiccant is present Allow the card to come to room temperature before opening the package liner Do not use powdered gloves Powder may interfere with the optics Use of culture media other than the recommended types must be validated by the customer laboratory for acceptable performance The card performs as intended only when used in conjunction with VITEK 2 systems Do not use glass test tubes Use clear plastic polystyrene tubes only Variation exists among test tubes of standard diameter Carefully place the VITEK 2 Systems Product Information 3 1 069043 4EN1 Storage and Handling YST Product Information tube into the cassette If resistance is encountered discard and try another tube that does not require pressure to insert Ensure that cards are filled properly a
191. alized percent probability for low discrimination is replaced by the percent probability for the selected organism If the Organism Identification returns a single organism or no organisms you cannot change the Organism Identification 3 The system software displays a window requesting that you confirm the changed information is correct 4 The system software updates the Organism Name for all cards in the selected isolate group and performs the necessary re analysis Viewing or Updating Patient Specimen Information If Patient or Specimen Information is enabled you can update this at any time 1 Select an Isolate group VITEK 2 Systems Software User Manual 8 13 510773 3EN1 Modifying Isolate Groups and Test Cards View and Maintain Isolate Results Note Changes cannot be made at the card level 2 Click View Specimen Information to make changes to the patient information View and Maintain Isolate Results View By isolate Lab ID Filter By Show All S Staph aureus 91 0 v Organism Figure 8 7 View Patient Specimen Information Icon 3 The View Specimen Information window appears Y view Specimen Information Figure 8 8 View Specimen Information Window 4 Make any necessary changes to the specimen information 5 The system software confirms the changes and is updated to reflect the changes For details see Chapter 5 Manage Patient Information Clinical Use 8 14
192. also 1 2 3 6 acidification fermentation of L appear on the BCL rhamnose observed with card but are pH indicator e g phenol recommended as red bromocresol purple supplemental tests etc since results of conventional macromethods may differ from rapid commercial micromethods MOB Motility Microscopic examination 12 for the motility of cells moving against the general flow of liquid under the cover slip Phase contrast microscopy is recommended NaCl 5 Growth in 5 NaCl Ability to grow in the Some similar tests presence of 5 NaCl also appear on the BCL card but are recommended as supplemental tests since results of conventional macromethods may differ from rapid commercial micromethods NAGLN N acetyl Acid produced from the Some tests also 1 2 3 Glucosamine fermentation of N acetyl appear on the BCL D glucosamine observed card but are with pH indicator e g recommended as phenol red bromocresol supplemental tests purple etc since results of conventional macromethods may differ from rapid commercial micromethods VITEK 2 Systems Product Information 5 21 069045 2EN1 BCL Supplemental Tests BCL Product Information Abbreviation Table 5 16 BCL Supplemental Tests Test Name Description Comments Reference NO3 Nitrate reduction Ability to reduce nitrates to nitrites or nitrogen gas On the addition of reagents a red coloration indicates presence of nitrites A yellow color remai
193. an one phenotype is detected the most resistant change is used MIC Test Differences AES can propose up to 10 two fold dilution changes increase or decrease to the MIC to match a phenotype s The actual MIC is not changed on the Laboratory Results A test change means that a test can be modified A test correction is equal to 10 MIC dilutions Antibiotic Family Lists each tested antibiotic family Antibiotic s Test Lists the antibiotic tested 8 24 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Viewing AES Graphic Clinical Use Detected Phenotypes Lists one or more phenotypes proposed by AES for each antibiotic family Description of Findings Explains why AES proposed a change to the MIC Antibiotic Deductions Explains why the antibiotic was deduced either because of Antibiotic equivalency or the detection of a phenotype Y detailed AFS Report AES Detail Report PARTIAL RESISTANT RESISTANT QUIN M5 bas bsersraruousseg az Merpati Fieber cen mame Changes NN Maro trant on Change im A TEE E L DPagetoti B85x11m Print Figure 8 15 Detailed AES Report 4 Click Print to print the report to the workstation printer Viewing AES Graphic Clinical Use The purpose of the AES Graphic is to show by phenotype the expected AES MIC distributions in the AES database superimposed with the observed values for selected isol
194. and B Phase contrast microscopy mycoides by the is recommended production of crystals VP Voges Proskauer Ability to produce acetoin 12 from the fermentation of glucose Culture Requirements Table Table 5 17 Culture Requirements Age of VITEK 2 Media Age of Incubation Inoculum Dilution mir ie Card Culture Conditions Density for AST Loading Instrument BCL TSA 18 to 24 Mesophilic species 1 80 to N A lt 30 minutes CNT hours 30 C to 37 C aerobic 2 20 non CO McFarland za Standard Thermophilic species 54 C to 56 C aerobic non CO This medium was used in the identification product database developments and will give optimal performance 2 Bacillus anthracis strains must be tested using cultures grown for 15 to 18 hours See the Limitations section Culture Requirements Table Media abbreviations TSA Trypticase Soy Agar CNT Count TACT irradiated Trypticase Soy Agar VITEK 2 Systems Product Information 5 23 069045 2EN1 Bibliography BCL Product Information Bibliography 1 2 3 4 5 6 7 8 9 10 11 Claus D amp Berkeley R C W 1986 Genus Bacillus Cohn 1872 In Bergey s Manual of Systematic Bacteriology Vol 2 pp 1105 1139 Edited by P H A Sneath N S Mair M E Sharpe amp J G Holt Baltimore Williams amp Wilkins Gordon R E Haynes W C Pang C H N 1
195. and incubate until spores are observed by microscopy 2 Freeze the broth culture at 70 C or Refrigerate agar slants at 2 C to 8 C 3 Subculture to TSA twice before running QC Note Avoid repeated thawing and refreezing by either freezing in single use aliquots or removing a small portion of frozen organism preparation with a sterile applicator stick BCL Quality Control Table Aneurinibacillus aneurinilyticus ATCC 11376 LMG 12387 Bacillus circulans ATCC 61 LMG 16633 Bacillus licheniformis ATCC 12759 LMG 7560 Brevibacillus agri ATCC 51663 LMG 15103 Brevibacillus laterosporus ATCC 64 LMG 16000 Geobacillus stearothermophilus ATCC 12978 LMG 21890 Paenibacillus macerans ATCC 8509 LMG 21891 Paenibacillus polymyxa ATCC 7070 LMG 21892 Virgibacillus pantothenticus ATCC 14576 LMG 7129 The following organisms marked with an asterisk indicate additional quality control if required by local regulatory agencies VITEK 2 Systems Product Information 5 9 069045 2EN1 BCL Quality Control Table BCL Product Information Table 5 6 QC Organism Aneurinibacillus aneurinilyticus ATCC 11376 LMG 12387 BXYL v AGAL v INO dMNE v PVATE v NaCl 6 5 LysA v AlaA v MdG dMLZ z AGLU KAN AspA v TyrA V ELLM v NAG dTAG OLD LeuA v BNAG v MdX PLE x dTRE ESC v PheA v APPA v AMAN v IRHA B INU v TIZ v ProA CDEX B MTE BGLU v dGLU POLYBR BGAL v dGAL GlyA v BMAN dRIB v PyrA
196. aniSMS 6 15 Printing the SRF Biopattern Report 6 15 SRF Organism Report Industrial Use 6 16 MAINTAIN CUSTOMER QUALITY CONTROL aaa nnunanannanna nanasa zna nanasa zna nnanann nanasa ananasa ana ana ana znana 7 1 Introduction to Working with QC Results 7 2 Viewing QC Results 7 2 VITEK 2 Systems Software User Manual iii 510773 3EN1 Table of Contents Viewing Selected QC Results 7 3 Creating a Custom Filter to View Cumulative QC Information 7 4 Adding or Modifying QC Comments 7 5 Changing the QC Reference ID 7 5 Changing the Setup Technologist s Name 7 5 Viewing QC Isolate Audit Records Supervisor Only 7 5 Viewing Card Details 7 6 Reviewing QC Results 7 7 Approving QC Results Supervisor Only 7 8 Applying Electronic Signature 7 8 Creating and Viewing Batch Results 7 9 Batch Review and Approve 7 11 Recording Shipments 7 11
197. ard and button commands are in proper case bold Example Start gt Programs Names and Titles The names and titles of menus dialog boxes fields icons and toolbar buttons are in proper case bold Example Setup window The names of windows for views are in proper case but are not bold Example Configuration view Press The term press refers to holding down a key on the keyboard to initiate action in the software Example Press Enter Select The word select is generally used for selecting menus menu commands and user navigation Example Select Main gt Configuration gt Version 1 6 VITEK 2 Systems Software User Manual 510773 3ENI How to Use This Manual Warnings Cautions and Information User Input Instructions for user input begin with the word type or enter These instructions use bold for literal user input and italic for placeholders Example of literal user input log in as sjones and password sjones In this example type exactly what you see on the page sjones in this example Example of a placeholder Enter your password before you In this example type your assigned password Warnings Cautions and Information This manual uses different types of symbols to alert you to important information Symbols and their associated information are labeled in text where they occur and set off from surrounding paragraphs as shown in the following examples Warning is a stateme
198. ased solely on category agreement CA because at the time the performance was established less than five discrete two fold dilutions were evaluated A minimum of five dilutions is necessary to perform essential agreement EA based on one two fold dilution These instances are designated by a c footnote in individual product package inserts The following performance table has values for CA only when EA was not established at the time of FDA clearance Reproducibility of VITEK 2 systems was established using a set of on scale organisms VITEK 2 Systems Product Information 6 13 510774 3EN1 Susceptibility Product Information Performance Characteristics sl elle nfs eo ef e cf e e rof rej olsl feel 1 so mo am sel poppe mee zl ef e zap we of af os ee for n w s el s mm CRE Eee Ts uupojeyda2 vov so oo avl aal sf me se so al e IT Jsle rje peso e eof al ose eof eof si ew 3e soj mw mme Os so emp se rs so fee amo uepegins ouf oof oo zl KO EI e ew zl wo II IT slej sloj Less ces sr oo e soj eo oof nij mejo saj soj w pev ploy oiue nae EK L T6 vc 96 34 IST DWV uyprxowy RE Se ER EME sz voj oo s oo voj oo ose 3 w w te am am ann vom e am amn vaw apo wey uowwo u w 13y A1039 e5 u w 18y Jenuoess3 ISW oAneSoN WeLID JOJ SIYSH PLILYJ DDULUWOJ d 1SV DANE ON Wes 10 SYSH PLILYJ DIULWOH d JUDO ds JEIGOHIUHUW Z MALIA T 9 9 q
199. assette Information 4 12 Editing Modifying Cassette Information 4 14 Ejecting Cards from Instrument 4 15 Using the Virtual Cassette Workflow 4 16 Creating a Virtual Cassette 4 16 Viewing Reconciliation Details 4 19 Deleting a Virtual Cassette 4 19 Using the Smart Carrier Station SCS 4 21 Smart Carrier Cassette Information 4 22 Managing Smart Carrier Station Cassettes 4 22 Setting Up and Entering Quality Control QC Information 4 24 VITEK 2 Systems Software User Manual 4 1 510773 3EN1 VITEK 2 Systems Workflow Set Up Test Cards and Cassette Information VITEK 2 Systems Workflow There are three methods for setting up test cards Set Up Tests Post Entry Workflow Allows you to load the cassettes first and enter the cassette information after the VITEK 2 Compact instrument reads the bar codes e Virtual Cassette Entry Allows you to create a virtual representation of the cassette information then load the actual cassettes into a VITEK 2 Compact instrument Smart Carrier Station SCS Allows you to setup a cassette on a dedicated workstation and transfer the saved cassette information to a VITEK 2 instrument and then on to the VITEK 2 Systems software Note When you load the cassette into the instrument the instrument reads the bar code information from the cards and cassettes and automatically sends the information to the system software For details on loading the cards and casse
200. assimilation LACa 0 96 mg 24 METHYL A D GLUCOPYRANOSIDE assimilation MAdGa 0 5 mg 26 D CELLOBIOSE assimilation dCELa 0 5 mg 27 GAMMA GLUTAMYL TRANSFERASE GGT 0 0228 mg 28 D MALTOSE assimilation dMALa 0 5 mg 29 D RAFFINOSE assimilation dRAFa 0 5 mg 30 PNP N acetyl BD galactosaminidase 1 NAGAI 0 0306 mg 32 D MANNOSE assimilation dMNEa 0 3 mg 33 D MELIBIOSE assimilation dMELa 0 3 mg 34 D MELEZITOSE assimilation dMLZa 0 3 mg 38 L SORBOSE assimilation ISBEa 0 3 mg 39 L RHAMNOSE assimilation IRHAa 0 3 mg 40 XYLITOL assimilation XLTa 0 3 mg 42 D SORBITOL assimilation dSORa 0 1875 mg 44 SACCHAROSE SUCROSE assimilation SACa 0 3 mg 45 UREASE URE 0 15 mg 46 ALPHA GLUCOSIDASE AGLU 0 036 mg 336 0 C i lt i i C VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Table 3 13 YST Well Contents YST Well Contents Well Test Mnemonic Amount Well 47 D TURANOSE assimilation dTURa 0 3 mg 48 D TREHALOSE assimilation dTREa 0 3 mg 49 NITRATE assimilation NO3a 0 03 mg 51 L ARABINOSE assimilation IARAa 0 3 mg 52 D GALACTURONATE assimilation dGATa 0 15 mg 53 ESCULIN hydrolyse ESC 0 225 mg 54 L GLUTAMATE assimilation IGLTa 0 15 mg 55 D XYLOSE assimilation dXYLa 0 5 mg 56 DL LACTATE assimilation LATa 0 15 mg 58 ACETATE assimilation ACEa 0 15 mg 59 CITRATE SODIUM assimilation CITa 0 15 mg 60 GLUCURONATE ASSIMILATION GRTas 0 15 mg 61 L PROLINE a
201. at 1 3 VITEK 2 Systems Product Information 5 13 069045 2EN1 Organisms Identified by the BCL Card BCL Product Information Data on file at bioM rieux Inc Organisms Identified by the BCL Card Aneurinibacillus aneurinilyticus Bacillus amyloliquefaciens Bacillus anthracis Bacillus badius Bacillus cereus Bacillus circulans Bacillus coagulans Bacillus firmus Bacillus fusiformis Bacillus lentus Bacillus licheniformis Bacillus megaterium Bacillus mycoides Bacillus pumilus Bacillus smithii Bacillus sphaericus Bacillus sporothermodurans Bacillus subtilis Bacillus thuringiensis Brevibacillus agri Brevibacillus borstelensis Brevibacillus brevis Brevibacillus centrosporus Brevibacillus choshinensis Brevibacillus invocatus Brevibacillus laterosporus Brevibacillus parabrevis Geobacillus stearothermophilus Geobacillus thermodenitrificans Geobacillus thermoglucosidasius Paenibacillus alvei Paenibacillus amylolyticus Paenibacillus durus formerly known as Paenibacillus azotofixans Paenibacillus glucanolyticus Paenibacillus macerans Paenibacillus pabuli Paenibacillus peoriae Paenibacillus polymyxa Paenibacillus thiaminolyticus VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information Organisms Identified by the BCL Card Paenibacillus validus Virgibacillus pantothenticus Virgibacillus proomii VITEK 2 Systems Product Information 5 15 069045 2EN1 BCL Well
202. ate Patient ID must be unique Name required Location Physician Comments Note You can enter the specimen information at the same time For details on entering specimen information see Adding Specimens on page 5 4 Note You cannot add a patient without adding a specimen If a patient has already been entered with one or more specimens you can always enter additional specimens but you cannot enter a patient without an associated specimen VITEK 2 Systems Software User Manual 5 3 510773 3EN1 Adding Specimens Manage Patient Information Clinical Use Adding Specimens When you view and maintain patient information you can add more than one specimen to a patient that has already been entered To do so follow these steps 1 From the View and Maintain Patient Information view select the patient and click Add Specimen Figure 5 4 Add Specimen Icon 2 Enter the Specimen information in the Add Patient Specimen window 3 Fill in the following fields Lab ID required Type required for example Blood Urine Wound etc Source for example right lower leg etc Collection Date Collection Time Comments Linking Isolate and Patient Information Patient demographics must be enabled from within user configuration to maintain the association between isolates and specimens in the active workspace For details see Chapter 10 General Configuration When a patient record is created th
203. ated Unusual or highly pathogenic organism identifications AST Card Analysis Problems One or more terminated drugs and the card status are not terminated Insufficient growth in the wells Card status is Terminated 9 6 VITEK 2 Systems Software User Manual 510773 3ENI Configure Results Analysis and Review Results Validation Configuration Table 9 1 Critical Isolates Analysis Problem Description AES Analysis Problems AES confidence of Inconsistent the number of MIC corrections allowed has been exceeded Isolate with certain phenotypes therapeutic interpretation changes and or MIC corrections if these are enabled in configuration Isolate with an unusual MIC result for one or more antibiotics Isolate results in an AES confidence of Expert Analysis Not Performed when biologic validation is enabled AES proposes a change to the offline test on an isolate AES proposes a change to the test performed on an AST card Configuring Result Validation VITEK 2 Systems Software User Manual 9 7 510773 3EN1 When results are qualified or stopped for any reason depending on how validation is configured they may need to be reviewed or approved by a Laboratory Technologist or a Supervisor 1 From within the Result Validation Configuration view you can configure isolates to stop for review based on your lab s needs 2 To make changes to the Result Validation settings click Unloc
204. ated with universal precautions 23 26 Storage and Handling Upon receipt store VITEK 2 GP cards unopened in their original package liner at 2 C to 8 C Specimen Preparation For specimen preparation information see the Culture Requirements Table on page 2 22 Materials When used with VITEK 2 instrumentation the GP card is a complete system for routine identification testing of most significant Gram positive organisms Required materials are 2 2 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information Procedure VITEK 2 GP Card VITEK 2 DENSICHEK VITEK 2 DENSICHEK Power Adapter Lithium Battery for DENSICHEK DENSICHEK Calibrator VITEK 2 Cassette Sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 12x 75 mm clear plastic polystyrene disposable test tubes Sterile sticks or swabs Appropriate agar medium See Culture Requirements Table on page 2 22 Optional accessories Saline Dispensers Pre dispensed saline test tubes aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 Test tube caps Vortex Procedure For product specific information see the Culture Requirements Table on page 2 22 Note Prepare the inoculum from a pure culture according to good laboratory practices In case of mixed cultures a re isolation step is required It is recommended that a purity plate be done to ensure that a pure culture was used for testing 1
205. ates AES uses a ranking system to determine the confidence of the phenotypic match detected The following rankings are displayed in the AES Graphic Possible phenotype One star represents a good match Recognized phenotype Two stars represents a better match kkk Best phenotype Three stars represents the best match VITEK 2 Systems Software User Manual 8 25 510773 3EN1 Viewing AES Graphic Clinical Use View and Maintain Isolate Results Viewing MIC Distributions To view the MIC distributions for phenotypes corresponding to susceptibility test results 1 From within the View and Maintain Isolate Results view select an isolate group containing an AST card 2 Click View AES Graphic Note The AES Graphic displays only the tested antibiotic results 3 The AES graphic appears in the active workspace providing a visual graph depicting the antibiograms 4 Move the mouse over the greater than less than or equal to indicators to see popup containing the observed MIC value The shape of the indicator gives you a graphical representation of the MIC distribution values gt Greater than Observed MIC is greater than the highest value tested 4 Less than MIC was lower than the lowest value tested E Equal to MIC is equal to the value observed 8 26 VITEK 2 Systems Software User Manual 510773 3ENI View and Maintain Isolate Results Selecting and Moving a Test Organism Proteus enger u fpecies
206. ation Changes After applying all of the necessary changes to the configuration settings you need to save and lock the custom changes 1 From the Configuration views click Save to apply your changes to the configuration settings bk Figure 10 4 Save Icon 2 If you decide to cancel the changes click Cancel Changes This reverts to the configuration settings applied the last time they were saved Figure 10 5 Cancel Changes Icon 3 To apply your changes and move to another view lock the Configuration view For details on locking the view see Unlock Lock Configuration View for Changes on page 10 3 General Configuration As a Laboratory Technologist you can only view the configuration settings As a Supervisor you have the option to view and customize the configuration settings General Configuration settings include the following sections System Information System Mode Print Miscellaneous 10 4 VITEK 2 Systems Software User Manual 510773 3ENI Configure and Maintain Workstation General Configuration To access the General Configuration view follow these steps 1 From the Main view select General Configuration from the Configuration drop down list 2 The General Configuration view appears Note Only a Supervisor can unlock this view to make changes and customize the general features For a Laboratory Technologist this view is Read only Customizing General Configuration Supervisor Only
207. ation Guideline 8 Select the phenotypes and click the Arrow icon to include them 9 Click OK when you have made your selections Sorting Information The status of the parameter set appears in the workspace area You can sort the displayed data by choosing the corresponding value of the Sort By drop down menu Note You can also choose the order of the columns using drag and drop Dragging and dropping the columns has no impact on the sorting of the data contained in each column Creating a Custom Therapeutic Interpretation Guideline To create a new custom guideline follow these steps Note To change the interpretation guideline name you must be on a custom parameter set 1 Select the specific guideline under the parameter set that you want to modify and click New Component 2 Change the Name of the new custom guideline to save it and update the parameter set Note The new interpretation guideline name must be unique If the name entered already exists or if the name field is blank an error message appears with instructions on how to completely customize the guideline 3 Click OK 4 The system software creates a custom writable copy of the current predefined guideline before you can customize it Modifying Custom Therapeutic Interpretations To change the value of a therapeutic interpretation the user has to pick from a list of values proposed by the system software To change the Therapeutic Interpretation fo
208. ation Message ees 11 9 Figure 11 7 Create New Component ICON nr 11 10 Figure 11 8 Create a Custom Parameter Set 11 10 Figure 11 9 MIC Interpretation Guidelines EE 11 12 Figure 11 10 Create New Component ICON rene 11 12 Figure 11 11 Create Custom Parameter Set nn 11 13 Figure 11 12 Modify Breakpoints EEN 11 14 Figure 11 13 View Therapeutic Guideline rs 11 16 Figure 112142 Filter ICON iiie latro iterare a a aaa dud 11 17 Figure 11 15 Select One or More Organisms EE 11 17 Figure 11 16 ArrOW ICON 1 11 17 Figure 11 17 Select One or More Antibiotics EENEG 11 18 xiv VITEK 2 Systems Software User Manual 510773 3ENI List of Figures Figure 11 18 Figure 11 19 Figure 11 20 Figure 11 21 Figure 11 22 Figure 12 1 Figure 12 2 Figure 12 3 Figure 12 4 Figure 12 5 Figure 12 6 Figure 12 7 Figure 12 8 Figure 12 9 Figure 12 10 Figure 12 11 Figure 12 12 Figure 12 13 Figure 12 14 Figure 12 15 Figure 12 16 Figure 12 17 Figure 12 18 Figure 12 19 Figure 12 20 Figure 12 21 Figure 12 22 Figure 12 23 Figure 12 24 Figure 12 25 Figure 12 26 Figure 12 27 Figure 12 28 Figure 12 29 Select One or More Phenotypes nes 11 18 Modify Custom Column EENEG 11 20 Add a New Therapeutic Interpretation enne 11 20 Select One or More Organism res 11 21 User Changes Report rennes 11 22 BCI Connection Status nn 12 3 Le EE 12 3 SI AUC E 12 4 BCI Connection Status annees 12 6 Alarm Connection seele p
209. ation Set Up Test Cards and Cassette Information Setting Up and Entering Quality Control QC Information To set up a Quality Control QC Test for new card shipments 1 When defining isolate groups select the check box beside the card slot that you want to designate as a QC test 2 The system software verifies that the card is part of a QC shipment 3 If a shipment was already created for this lot the Set Up QC Test window appears If a shipment was not created for this card lot the Record Shipment window appears pd Bor code iz supposed to bo OIC card Bar Code i supposes to be 71 VITEK 2 technology Figure 4 18 Set Up QC Test Window 4 Select the QC Reference ID from a list of QC Reference IDs and associated organism names appropriate for the card type of the selected card For Example ATCC25922 E coli Note QC Reference IDs can be selected from a list 5 The following associated QC information appears Card Type Card Lot Number 4 24 VI S I ITEK 2 Systems Software User Manua 510773 3EN1 Set Up Test Cards and Cassette Information Setting Up and Entering Quality Control QC Information Card Expiration Date Card Received Date if only one shipment for lot number Technologist s name laboratory technologist who entered lot information 6 If more than one shipment was recorded for the lot number the system prompts you to select a Received Date from a list to select
210. ation in the presence of phenol red VP VOGES PROSKAUER Ability of some species 1718 21 to produce acetoin from glucose fermentation YELLOW YELLOW PIGMENT Ability of certain species For example used 17 18 21 to produce yellow to differentiate pigmented colonies on E casseliflavus non differential media from E gallinarum O VITEK 2 Systems Product Information 2 21 069042 5EN1 Culture Requirements Table GP Product Information Culture Requirements Table Table 2 15 Culture Requirements Age of up wi Ae Inabaton Inoculum manias S Card Culture Conditions Density for AST Loading Instrument GP TSAB 12 to 48 35 C to 37 C 0 50 to 0 63 N A lt 30 minutes CBA hours 5 to 10 CO McFarland TSA or Aerobic non CO Standard CHOC CHOC PVX CHBA TSAHB CPS ID3 CNT TSAL MSA BP GP and AST TsaB 18 to 24 35 C to 37 C 0 50 to 0 63 280 uLin lt 30 minutes GP pair CBA hours 5 to 10 CO McFarland 3 0 mL or Aerobic non CO Standard saline These media were used in the identification product database development and will give optimal performance Culture Requirements Table Media Abbreviations BP Baird Parker CBA Columbia sheep blood agar CHBA Columbia horse blood agar CHOC Chocolate agar CHOC PVX Chocolate Polyvitex CNT Count TACT CPS ID3 CPS ID3 MSA Mannitol salt agar TSA Trypticas
211. aureus 207 1 Entero avium lt AE Ee EH lt i lt i lt i lt i lt Figure 8 3 Navigation Tree 8 6 Vi 3 ITEK 2 Systems Software User Manua 510773 3EN1 View and Maintain Isolate Results Search by Accession Number Search by Accession Number When viewing the navigation tree you can search isolate results by selecting the Search Accession Number icon 1 From the View and Maintain Isolate Results view select the Search Accession Number icon Figure 8 4 Search Accession Number Icon 2 From the Accession Number window enter an Accession Number Search Accession Number Accession Humber 106 Figure 8 5 Search Accession Number Window 3 Click OK to complete the search The system will search for the Accession Number within the navigation tree and will display the results Status Icons and Descriptions Isolates appear in the navigation tree of the View and Maintain Isolate Results view Based on the configuration settings for your laboratory you may need to provide the system software with additional information before the results can become final The icon beside a result represents its status VITEK 2 Systems Software User Manual 8 7 510773 3EN1 Status Icons and Descriptions View and Maintain Isolate Results The following table describes the status of the results and defines the icons that appear beside the results in the na
212. ble performance A Gram stain should be performed to determine an organism s Gram reaction and morphology prior to selecting which identification card to inoculate VITEK 2 Systems Product Information 1 1 069041 4EN1 Storage and Handling GN Product Information The card performs as intended only when used in conjunction with VITEK 2 systems Do not use glass test tubes Use clear plastic polystyrene tubes only Variation exists among test tubes of standard diameter Carefully place the tube into the cassette If resistance is encountered discard and try another tube that does not require pressure to insert Ensure that cards are filled properly and do not load any cards that are filled improperly Prior to inoculation inspect cards for tape tears or damage to the tape and discard any that are suspect Check the saline level in the tubes after the vacuum fill Give special consideration to specimen source and patient drug or antimicrobic regimen Interpretation of test results requires the judgment and skill of a person knowledgeable in microbial identification testing Additional testing may be required GN Supplemental Tests on page 1 20 WARNING All patient specimens and microbial cultures are potentially infectious and should be treated with universal precautions 13 16 It is suggested that highly pathogenic species such as Brucella melitensis Burkholderia mallei Burkholderia pseudomallei Escherichia coli 015
213. boots End of Day Processing and Daily Maintenance End of day processing occurs when the system is not in use This usually occurs late at night in most labs End of day processing is also the time when BCI transactions are at a minimum for upload and downloads The default time that end of day processing begins is 3 00 AM The system software application will not start if the end of day processing has begun If an error occurs during this nightly process the system software applies all of the end of day processing that is not hindered by the error or simply does not get performed due to an error in the process End of Day Processing Begins The system software automatically initiates end of day processing when the timer indicates it is time Complete Daily Workspace Maintenance Nightly the system software begins cleanup in the active workspace The following section details what happens during cleanup For details on 14 4 VITEK 2 Systems Software User Manual 510773 3ENI Data Backup and Daily Maintenance End of Day Processing and Daily Maintenance configuring end of day processing see Chapter 10 Configure and Maintain Workstation Patient Information Cleanup If patient demographics is enabled the system software removes any aged seven day old patients or specimens not linked to an isolate A specimen will remain in the patient workspace for seven days after the specimen creation date If a patient is not linked to any specimen
214. can be used for this test 4 18 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information Vi S 4 19 5 Table 4 14 NH Supplemental Tests NH Supplemental Tests Abbreviation Test Name Description Comments Reference UREASE Urease Hydrolysis of urea Some tests also 6 10 releases ammonia appear on the resulting in NH card but are alkalinization of the recommended as medium observed with supplemental a pH indicator e g red tests since results color formation in the of conventional presence of phenol macromethods red often differ from rapid commercial micromethods V FACTOR V FACTOR NAD REQUIREMENT NAD required for 9 10 growth X FACTOR X FACTOR HEMIN Hemin required for 6 10 REQUIREMENT growth dFRUCTOSE D FRUCTOSE acidification Acidification of carbon Some tests also 4 6 10 13 source observed with appear on the dGALACTOSE D GALACTOSE acidification pH indicator e g NH card but are phenol red recommended as dGLUCOSE D GLUCOSE acidification bromocresol purple supplemental etc tests since results LACTOSE LACTOSE acidification of conventional macromethods dMALTOSE D MALTOSE acidification often differ from rapid commercial dMANNITOL D MANNITOL acidification micromethods dMANNOSE D MANNOSE acidification dRAFFINOSE D RAFFINOSE acidification SACCHAROSE SACCHAROSE SUCROSE acidification dTREHALOSE D TREHALOSE acidification ITEK 2 Systems Product Informat
215. cassette the following information appears in the cassette workspace Cassette ID displays the number on the cassette Name of the Instrument where the cassette was loaded appears in the cassette workspace Load Time displays the date and time the cassette bar code was read by the Instrument 4 6 VITEK 2 Systems Software User Manual 510773 3ENI Set Up Test Cards and Cassette Information Defining the Selected Cassette List of Setup Technologists select your name from the drop down list if your name does not already appear in the field Note If 21CFR 11 Compliance Mode is enabled you are not permitted to change the Setup Lab Tech Name When 21 CFR 11 Compliance Mode is enabled the Setup Technologist is the user logged into the system software when the cassette was loaded in to the instrument List of Bench Names if enabled in configuration select the appropriate bench name or if the Bench name that you are working at does not appear or is incorrect The individual card information for each slot in the cassette appears in a table below the cassette definition information 3 Enter additional information to further define the individual cards in the cassette For details on defining individual test cards see Defining the Cards in the Cassette on page 4 7 in the following section Defining the Cards in the Cassette The cassette workspace also displays the detailed card information in a table that de
216. cation call will be Nonreactive biopattern The following species could potentially trigger this note if a test was atypical or fell within the uncertainty zone Table 2 4 Non Reactive Species Alloiococcus otitis Dermacoccus nishinomiyaensis Dolosigranulum pigrum Gemella bergeri Kocuria rosea Kocuria varians Kytococcus sedentarius Leuconostoc mesenteroides ssp cremoris Micrococcus lylae Staphylococcus auricularis Streptococcus pluranimalium VITEK 2 Systems Product Information 2 7 069042 5EN1 Quality Control GP Product Information Quality Control Quality control organisms and their expected results are listed in the VITEK 2 GP Quality Control Table and should be processed according to the procedure for test isolates outlined in this document The GP card will identify the quality control organisms as one choice or within a low discrimination or slashline See GP Quality Control Table on page 2 9 for more details Frequency of Testing Currently it is recommended that you use your most stringent inspecting agency s guidelines for frequency of identification product testing Common practice is to perform QC upon receipt of shipment of the test kits Reactions must follow Online Product Information results If the results do not meet the criteria subculture for purity and repeat test If discrepant results are repeated perform an alternate identifica
217. ced from the 1 2 3 acidification fermentation of D arabinose observed with PH indicator e g phenol red bromocresol purple etc VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information BCL Supplemental Tests Table 5 16 BCL Supplemental Tests Abbreviation Test Name Description Comments Reference dFRUCTOSEa D Fructose Ability to use D fructose 5 6 assimilation dMANNOSE D mannose Acid produced from the Some tests also 1 2 3 acidification fermentation of D appear on the BCL mannose observed with card but are PH indicator e g phenol recommended as red bromocresol purple supplemental tests etc since results of conventional macromethods may differ from rapid commercial micromethods dSORBITOL D sorbitol Acid produced from the 1 2 3 6 acidification fermentation of D sorbitol observed with pH indicator e g phenol red bromocresol purple etc dTURANOSE D turanose Acid produced from the 1 2 3 acidification fermentation of D turanose observed with PH indicator e g phenol red bromocresol purple etc Egg Yolk Egg yolk agar Detects the presence of Bacillus cereus 1 2 6 the enzyme lecithinase group organisms which degrades egg yolk B anthracis B broth or agar forming a cereus B heavy white precipitate thuringiensis and B mycoides can be differentiated from all other species on the basis of a positive result for this te
218. chived Reports us 13 12 Figure 13 6 Search Audit Trail inner 13 13 Figure 13 7 Search Audit Trail ancre 13 14 Figure 13 8 Save Audit Trail to a CD kon EE 13 16 Figure 13 9 Export Results ICOM orne 13 16 Figure 13 10 Audit Trail Reports EE 13 17 xvi VITEK 2 Systems Software User Manual 510773 3ENI LisT OF TABLES Table 2 1 Table 4 1 Table 4 2 Table 6 1 Table 7 1 Table 8 1 Table 8 2 Table 8 3 Table 8 4 Table 8 5 Table 8 6 Table 8 7 Table 8 8 Table 9 1 Table 9 2 Table 9 3 Table 12 1 Table 12 2 Table 13 1 Table 13 2 Table 13 3 Table 13 4 Main Navigational Areas of the System Software EE 2 4 Cassette Status Descriptions nn 4 6 Card Definition Columns EENG 4 9 SRF Organism Definition Window ii 6 8 Isolate Icons and Descriptions EEN 7 2 Status Icons and Descriptions EEN 8 8 Qualified Isolates EE 8 9 Biochemical Res lts ett 8 19 MIC Values ete a tie dtt ten eot el ts 8 20 Antibiotic Interpretations EEN 8 20 Test int rprelations I 8 20 AES Confidence Levels nn 8 23 Report Contei e ee 8 32 Critical Isolates ate ttd anne 9 6 Result Validation Selections ternera tnter tton 9 8 Result Validations Settings EE 9 9 Configuration Parameters EE 12 17 BCI Upload Tab Settings stent ttt ttt ttt ttt 12 27 User Group Descriptions nn 13 2 Default User ACCOUINS denge 13 3 Isolates Eligible For Archive ENEE 13 9 Search Events VITEK 2 Systems Software User Manual 510773 3EN1 xvii
219. cillin Ticarcillin Clavulanic Acid Cephalosporins and Cephems 1st Cefadroxil Cefalotin Cefalexin Cefazolin Cefradine 2nd Cefaclor Cefamandole Cefmetazole Cefonicid Cefotetan Cefoxitin MIC test only not the cefoxitin screen test Cefprozil Ceftibuten Cefuroxime Sodium Cefuroxime Axetil 3rd Cefetamet Cefixime Cefoperazone Cefotaxime Cefpodoxime Ceftazidime Ceftizoxime Ceftriaxone 4th Cefepime Loracarbef Carbapenems Imipenem Meropenem and Ertapenem Latamoxef Moxalactam B 2 VITEK 2 Systems Software User Manual 510773 3ENI Appendix B Forcing Rules Rule 2 If any type of Enterococcus species is tested then the result is automatically forced resistant for the following antibiotics Cephalosporins 1st Cefadroxil Cefalexin Cefalotin Cefazolin Cefradine 2nd Cefaclor Cefamandole Cefmetazole Cefonicid Cefotetan Cefoxitin Cefprozil Ceftibuten Cefuroxime Sodium Cefuroxime Axetil 3rd Cefatamet Cefixime Cefoperazone Cefotaxime Cefpodoxime Ceftazidime Ceftizoxime Ceftriaxone 4th Cefepime Aminoglycosides Amikacin Gentamicin Kanamycin Netilmicin Tobramycin Clindamycin Trimethoprim Sulfamethoxazole VITEK 2 Systems Software User Manual B 3 510773 3EN1 Appendix B Forcing Rules Rule 3 If Beta Lactamase BLA is positive when testing Enterococcus species then the results are forced resistant for the following antibiotics Amoxicillin Ampicillin Azlocillin B
220. configured from the interface connection VITEK 2 Systems Software User Manual 12 9 510773 3EN1 Configure and Maintain BCI Link Operation 3 Link Operations e BCI UNUSED UNUSED UNUSED Figure 12 12 Links Select the link you want to view and maintain The window for the selected link is displayed e BI Figure 12 13 BCI Link bcr Link Operations COM Manager DER 4 Supervision Transaction Log EM VITEK Unused Unused Link Name Status Upload Download Host Configuration Unused VITEK STARTED ENABLED ENABLED BACK IN SERVICE bioM rieux Literal COM1 961 Link Configuration Unused STOPPED ENABLED ENABLED BACK IN SERVICE bioM rieux Literal COM1 481 E Tools Unused STOPPED DISABLED DISABLED BACK IN SERVICE bioM rieux Literal COM1 481 Unused STOPPED DISABLED DISABLED BACK IN SERVICE bioM rieux Literal COM1 481 Unused Unused Unused 800 800 600 Figure 12 14 Link Operations Window Start Stop the Connection At any time the laboratory technologist can enable or disable the selected interface connection When the Start button appears selected the connection has started Select Stop to halt the connection The indicator light S changes to red 12 10 VITEK 2 Systems Software User Manual 510773 3EN1 Link Operation Configure and Maintain BCI Start Stop Figure 12 15 Start Stop Connection Transmission o
221. cs w Amikacin wf Amikacin ef Amodcilin ef Amoxcillin ef Amoxicilir Clavulanic Acid ef Amoxicillin Clavulanic Acid ef Ampicitin D 49 Ampiciin ef Ampicitin Sulbactam e Ampicilin Sulbactam ef Azitmromycin ef Azihromycin gP Axocillin ef Aziocillin 5 gP Aztreonam a Benzyipeniciliin P Carbenicittn P Cetacior ef Cetalotin P Cefamandole gP Cetazoin gP Cetepime P Cerime FP Cetmeno m Figure 11 17 Select One or More Antibiotics 6 Select the antibiotics and click the Arrow icon to include them Use Shift or Ctrl to select multiple antibiotics 7 Click Next when you have made your selections Y Filter Therapeutic Interpretations Select One or More Phenotypes AMINOGLYCOSIDES HETEROGENEOUS AMINOGLYCOSIDES HETEROGENEOUS AMINOGLYCOSIDES RESISTANT AAC 3 AMINOGLYCOSIDES RESISTANT AAC 3 AMINOGLYCOSIDES RESISTANT AAC 6 AMINOGLYCOSIDES RESISTANT ANT 2 AMINOGLYCOSIDES RESISTANT ANT 4 AMINOGLYCOSIDES RESISTANT APH 3 AMINOGLYCOSIDES RESISTANT GEN N AMINOGLYCOSIDES RESISTANT GEN N AMINOGLYCOSIDES RESISTANT GEN N AMINOGLYCOSIDES RESISTANT GEN E AMINOGLYCOSIDES RESISTANT HLF AMINOGLYCOSIDES RESISTANT HLF AMINOGLYCOSIDES RESISTANT HLF AMINOGLYCOSIDES RESISTANT HLF AMINOCI VAAGINES DEGISTANT nal Figure 11 18 Select One or More Phenotypes 11 18 VITEK 2 Systems Software User Manual 510773 3ENI View and Configure AES Viewing Therapeutic Interpret
222. cteristics 3 14 Organisms Identified by the YST Card 3 14 YST Well Contents 3 16 YST Supplemental Tests 3 18 Culture Requirements Table 3 21 Culture Requirements Table Media Abbreviations 3 21 Bibliography 3 22 NH PRODUCT INFORMATION LLL Lee 4 1 Intended Use 4 1 Description si se e ea sie nls 4 1 Ce TEEN 4 1 Storage and Handling 4 2 Specimen Preparation 4 2 Materials 52822 2 che rate mn ee east ater we ted 4 3 Procedure 5 oS DEE 4 3 ME 4 4 Identification Analytical Techniques 4 4 Identification Card Qualifying Messages 4 5 Percent Probability 4 5 Additional Information on Lab Report 4 6 Notes Associated with Certain Taxa 4 7 Notes Associated with Improperly Filled Card or Negative Profile biopatt rn lili slm IIS b Nur DE 4 7 Quality Controlia ai Let E lge iced ote 4 8 Frequency of Testing 4 8 Testing and Storage of QC Organisms 4 8 Storage Conditions 4 9 NH Quality Control Tables 4 10 Limitations resi kd j
223. cutive isolates you want to approve or hold down the Ctrl key and select the nonconsecutive isolates that you want to approve 3 The selected isolates appear in a list in the active workspace View and Maintain Isolate Results VITEK 2 technology Figure 8 35 Batch Approve 4 To approve these isolates click the Approve icon Note If Electronic Signature is enabled enter your password to batch approve these isolates 8 42 VITEK 2 Systems Software User Manual 510773 3EN1 CONFIGURE RESULTS ANALYSIS AND REVIEW 9 About This Chapter This chapter describes configuring ID and AST analysis This chapter also covers Results Validation Configuration settings Chapter Contents Configuring ID Analysis 9 2 View and Maintain ID Analysis 9 2 Selecting Organisms for Automatic Slashline 9 3 Enabling SRF Analysis Industry Use 9 3 Setting the Time to Eject Analyzed Cards 9 3 Configuring AST Analysis 9 3 Accessing AST Analysis Configuration 9 4 Card Ejection 9 4 Deducing Antibiotics 9 4 Suppressing Antibiotics 9 5 Results Validation Configuration 9 6 Critical Isolates 9 6 Configuring Result Validation 9 7 VITEK 2 Systems Software User Manual 9 1 510773 3EN1 Configuring ID Analysis Configure Results Analysis and Review Configuring ID Analysis Configuring Identification ID analysis consists of the following tasks Enable SRF Analysis Industrial Use Select Organi
224. cycle of the isolate appears in the window This displays all recorded user changes To view an isolate audit record 1 From the View QC Results view select an isolate from the navigation tree 2 Click the View Isolate Audit Records icon in the right view bar 3 The Isolate Audit Report appears VITEK 2 Systems Software User Manual 7 5 510773 3EN1 Viewing Card Details Maintain Customer Quality Control Waudit Trail ral fical Venter Isolate Audit Report Customer Number 123456789 Printed by sjones System Number 987654321 Printed Jan 6 2004 1717 Search Criteria Lab ID cab Isolate Number lt lt all gt gt QC Reference ID ATCC204094 User ID Recorded alb Event Type lt lt all gt gt Source Database Start Date lt lt all gt gt End Date lt lt all gt gt Audit Trail Events Created Isolat Nov 26 2003 1539 ATCC204094 035 ESRC Rensuper D Page 1 of 1 Base 110 in Figure 7 2 QC Audit Report Preview 4 Click Print to print a copy of the audit report 5 Click Export to export the QC audit report to a CD Make sure a CD is inserted Viewing Card Details From QC Results you can view the card details for individual AST and ID cards by clicking the Card Details icon in the right view bar The detailed card information appears in the active workspace Figure 7 3 Card Details Icon To print a report of the detailed card information click the Print icon 7 6 VITEK 2 S
225. d by the BCL Card on page 5 14 Description The BCL card is based on established biochemical methods 1 7 and on newly developed substrates There are 46 biochemical tests measuring carbon source utilization inhibition and resistance and enzymatic activities Final identification results are available in approximately 14 hours The database for the BCL card was developed using an extensive library of well characterized stock cultures A fresh isolate study was not undertaken due to the difficulty in obtaining sufficient fresh isolates for statistical relevance For a list of well contents see BCL Well Contents on page 5 16 Precautions Suspensions not within the appropriate zone on the VITEK 2 DENSICHEK may compromise card performance Do not use the card after the expiration date shown on the package liner Store the card unopened in the package liner Do not use the card if the protective package liner is damaged or if no desiccant is present Allow the card to come to room temperature before opening the package liner Do not use powdered gloves Powder may interfere with the optics Use of culture media other than the recommended types must be validated by the customer laboratory for acceptable performance VITEK 2 Systems Product Information 5 1 069045 2EN1 Storage and Handling BCL Product Information A Gram stain should be performed to determine an organism s Gram reaction and morpho
226. d like to view the QC Results select a specific QC Result 5 The selected result information appears in the active workspace VITEK 2 Systems Software User Manual 7 5 510773 3EN1 Viewing QC Results Maintain Customer Quality Control Creating a Custom Filter to View Cumulative QC Information Filter QC Results using your own filter criteria 1 From the View QC Results view select a View By option from the navigation tree 2 From the Filter By drop down list above the navigation tree select Custom 3 The Cumulative QC Search Criteria window appears Nb Cumulative QC Search Criteria Figure 7 1 Cumulative Custom Filter 4 Select from the following options to view the desired QC Results Select the Date Range Select the Card Type from the drop down list Select the QC Reference ID from the drop down list Type in a ot number if you want to view results from a specific Lot Number Select the check box to Show only deviations from expected results 5 Click OK 6 QC Isolates that meet the search criteria appear in the navigation tree 7 The filter criteria for the search that you performed appear at the top of the workspace area Note The actual MIC range result QC Isolate Group and Card Type are flagged if different from expected 7 4 VITEK 2 Systems Software User Manual 510773 3ENI Maintain Customer Quality Control Viewing QC Isolate Audit Records Supervisor Only Adding or Modifyin
227. d selected to copy to SRF is part of an isolate group the isolate group results status must be Final To copy the biopattern to the SRF database 1 From the View and Maintain Isolate Results view select the ID results that you want to copy to SRF and click the Send to SRF icon Do you want to copy the selected isolate to SRF Figure 8 21 Send to SRF 2 Aconfirmation window appears asking you to confirm copying this biopattern to SRF Click Yes to copy the biopattern 3 The SRF biopattern information for the isolate is recorded in the local SRF database Note If the card bar code is already entered an informational message appears and the SRF is not updated 4 Toview the SRF organism go to the View and Maintain SRF Data view For more details see Chapter 6 Maintain Supplemental React File Industrial Use Printing Result Reports From within View and Maintain Isolate Results view you can print isolate result reports The following reports are available from the Results view VITEK 2 Systems Software User Manual 8 31 510773 3EN1 Printing Result Reports View and Maintain Isolate Results Laboratory Report Chart Report Detailed Card Report Detailed AES Report Lab Report and Chart Report A Lab Report and a Chart Report contain report results of ID and AST tests for an isolate group These reports also contain validation information if AES is enabled The following table shows the report var
228. differential test in the identification of Haemophilus spp VITEK 2 Systems Product Information 4 17 532511 4EN1 NH Supplemental Tests Table 4 14 NH Supplemental Tests NH Product Information Abbreviation Test Name Description Comments Reference HIP HIPPURATE hydrolyse Hydrolysis of sodium Of the 10 hippurate releases Campylobacter glycine that produces a species only blue colored product Campylobacter after addition of jejuni gives a ninhydrin positive hippurate reaction IND INDOLE Ability of certain 6 10 13 species to split indole from tryptophan detected by a colored product revealed with a specific reagent e g Kovacs Ehrlichs DMAC reagents etc MOB MOTILITY Test for motility using Bacterial motility 10 13 hanging drop can be observed procedure or saline by placing a drop mount of bacterial suspension on a slide and viewing it under a microscope NO3 NITRATE REDUCTION Test for the ability to 6 10 13 reduce nitrate to nitrite or nitrogen gas ONPG BETA GALACTOSIDASE Presence of beta 5 6 9 10 galactosidase cleaves o nitrophenol beta D galactopyranoside to produce a yellow colored product OX OXIDASE Detection of the 6 10 presence of cytochrome C THAYER M Thayer Martin Agar Growth on selective Thayer Martin 6 10 medium used in the Agar New York differentiation of City Agar or Neisseria spp Chocolate Polyvitex Agar with VCAT
229. dividual to be a legally binding equivalent to the individual s handwritten signature In this case the system software uses User ID and Password authentication to electronically sign results once they are Reviewed or Approved Applying an electronic signature is the equivalent of entering your User ID and Password Depending on your system software configuration setting one or more isolate groups can be selected to be signed electronically To electronically sign results 1 Select the isolate or isolate groups to sign 7 8 VITEK 2 Systems Software User Manual 510773 3ENI Maintain Customer Quality Control Creating and Viewing Batch Results 2 The system software prompts you to enter your User ID and Password View By c Raterence D ar Filter thy Currert ad isolates 4100430797 St equ rooe A7 GP Mar 10 2004 2420100 pipe concen The selected isolate will be flagged as reviewed To continue enter your user ID YST Mee 10 2004 243010 and password and press OK v YST Mar 10 2004 2430 e cease Z VITEK 2technology Figure 7 6 Review Confirmation Window 3 The User Name and Password is authenticated and the system software applies the electronic signature to selected test cards 4 If you need to sign a subsequent set of tests during the same user session the system software prompts you to enter your password each time Note If the User ID is not valid the electr
230. dultsilsO1 10 09 2003 03 03 28 Download Sent mtrsllidB MXIpi350002lpdalp6 dultisils06 10 09 2003 09 43 55 Upload Sent mtrsli2lis1234561tDIpi1 425730 pv022 10 09 2003 09 45 56 TheraTrac Upload To be sent mlrsliiv2lis123456 itlDIpil 425730 pv022 lt ust TheraTrac Unused Unused eeo 800 000 600 Figure 12 7 Transaction Log v Search Transaction Log To search the transaction log you have the following options 1 Select a Start date and an End date 2 Type in any Text in the two text fields to help you identify the history log that you want to find VITEK 2 Systems Software User Manual 12 7 510773 3EN1 Configure and Maintain BCI 3 4 5 Transaction Log Choose the direction of the transaction by selecting either Reception Download Transmission Upload or Both from the Direction drop down list Click Search to update the current window dei Figure 12 8 Search Button This option allows viewing of the communications sessions that have taken place by providing the following information Date amp time Date and time of the transaction Link Name of the link with which the transaction occurred Direction Nature of the transaction upload or download Status Status of the transaction sent to be sent etc Data Content of the transaction reminder of the message received or sent Deleting Transaction Log Messages Note To delete uploaded messages you need to
231. e You must be a Supervisor to create a new SRF organism 1 From the Maintain SRF Data view in the navigation tree select SRF Organism from the View drop down list 2 The SRF Organism view appears 3 Click the Create SRF Organism icon Figure 6 7 Create SRF Organism 4 The Create SRF Organism window appears VITEK 2 Systems Software User Manual 6 7 510773 3ENI Creating and Maintaining SRF Organisms Supervisor Maintain Supplemental React File Industrial Use OS xi SRF Organism Details Status active SRF Organism Code SRF Organism Name Card Type GP Comment Figure 6 8 New SRF Organism Window 5 Enter the information described in the following table Table 6 1 SRF Organism Definition Window Field Description Status Active SRF Organism has already been activated for use on identification analysis Inactive The SRF Organism has not yet been activated for use on identification analysis SRF Organism Type a unigue user defined code that identifies the SRF Code Organism The code is limited to four alpha characters SRF Organism A user defined name of the SRF organism Name Card Type Type of card the identification analysis was recorded on Comment Enter an informational comment optional Note Be sure to enter a unique new organism code If the code already exists the SRF organism is not entered and the SRF database is not updated Note You
232. e 5 5 Search Inactive Reports Icon 2 The Search Inactive Reports window appears WG vier ani Marit am Patient information wells Saw wt fo lt SEJ Search Inactive Reports E x Search Inactive Reports Patient gt Labi Mares d Deene vus Colecton Date f lu a P IJ Frark Sentra 12 Z fred Roberts 12 DL Gery Dates 12 Lab Report AES Gen Report e Gwenetn Patrow Shans Gruber 12 e Patiort Accession Number Ote 8 Holy Gerero 12 D Jorn Lenin 1230 B C Kevin Sewet 12 E LJ Kishan Starter C i L Lesie Hope 123 X Uam Neesen 12 D L Pad McCartney e Perry Ho 123006 S I Steve Martin 127 5 Znicheng Botra t Preview Cancel a 4 Je 4 VITEK 2technology Figure 5 6 Search Inactive Reports Window 3 Enter your search criteria by filling out the fields Note If you choose a specific date range in the available date fields and the inactive isolate you are searching for did not previously have a collection date associated with it the search results will not display that isolate in the Search for Inactive Results window To see results for inactive isolates that did not have an assigned collection date leave the date range fields empty Inactive isolate search results that did not have an initial collection date will not display data in the Date column 4 Click Search The inactive reports t
233. e RA are Mein 4 13 Performance Characteristics 4 13 Organisms Identified by the NH Card 4 13 VITEK 2 Systems Product Information 532501 3EN1 Table of Contents NH Well Contents 4 15 NH Supplemental Tests 4 17 Culture Requirements Table 4 20 Culture Requirements Table Media Abbreviations 4 20 Bibliography 4 20 BCL PRODUCT INFORMATION 5 1 Intended Use rop Re AEN ee 5 1 D scriptiont od STEEN EE E HEELS ERE 5 1 PRECAUTIONS fe eer RE esa goblet nt te sts ae eye n tarte za 5 1 Storage and Handling 5 2 Specimen Preparation 5 2 Materials icc are see nes 5 3 Procedure e WEE ails tein ered 5 3 Results iia cn EE 5 4 Identification Analytical Techniques 5 4 Identification Card Qualifying Messages 5 6 Additional Information on the Lab Report 5 7 Notes associated with certain taxa 5 7 Notes associated with an improperly filled card or with a negative profile biopattern 5 7 Quality Control 5 8 Freguency of Testing 5 8 Testing and Storage of OC Organisms 5 8 St
234. e at 70 C 3 Subculture to TSAB twice before running QC Note Avoid repeated thawing and refreezing by either freezing in single use aliquots or removing a small portion of frozen organism preparation with a sterile applicator stick DW ae 922 CUUUU Wwe A EE Dodo Kafe AA 1 10 VITEK 2 Systems Product Information 069041 4EN1 GN Product Information GN Quality Control Table GN Quality Control Table Acinetobacter baumannii ATCC BAA 747 Enterobacter cloacae ATCC 700323 Klebsiella oxytoca ATCC 700324 Ochrobactrum anthropi ATCC BAA 749 Proteus vulgaris ATCC 6380 Shigella sonnei ATCC 25931 Stenotrophomonas maltophilia ATCC 17666 The organisms below marked with an asterisk indicate additional quality control if required by local regulatory agencies Table 1 5 QC Organism Acinetobacter baumannii ATCC BAA 747 APPA acp v exe sac sucr cMT v ADO dctu BAap dTaG NAGA BGUR PyrA Jeer v Proh v amre AGAL oms v IARL jor uP v jar PHOS GGA dcL v BGU PLE mr GyA v wm v BGAL dMAL TyA ske v ODC v fem H2S daman ue v o ILATk c aa v BNAG dMNE dsoRo AGLU IHISa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 1 6 QC Organism Enterobacter cloacae ATCC 700323 APPA Tam Jee sc am v Jor ADO dau
235. e identification pattern is not recognized a list of possible organisms is given or the strain is determined to be outside the scope of the database The printed lab report contains suggestions for any supplemental test necessary to complete the identification If the tests are not sufficient to complete the identification then standard microbiology references and literature should be consulted Certain species may belong to slashline mixed taxa This occurs when the biopattern is the same for the taxa listed Supplemental tests may be used to separate slashline taxa The following species belong to slashline taxa Table 2 1 Slashline Taxa Slashline Name Species Belonging to the Slashline Dermacoccus nishinomiyaensis Kytococcus Dermacoccus nishinomiyaensis sedentarius Kytococcus sedentarius Listeria ivanovii Listeria ivanovii ssp ivanovii Listeria ivanovii ssp londoniensis Micrococcus luteus lylae Micrococcus luteus Micrococcus lylae Staphylococcus capitis Staphylococcus capitis ssp capitis Staphylococcus capitis ssp ureolyticus 2 4 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information Percent Probability Table 2 1 Slashline Taxa Staphylococcus hominis Staphylococcus hominis ssp hominis Staphylococcus hominis ssp novobiosepticus Streptococcus infantarius ssp coli Streptococcus bovis Streptococcus bovis Streptococcus infantarius ssp coli Streptococcu
236. e is a custom guideline the Based On field displays the name of the guideline that the custom guideline is based on Wain View Knowledge Bese Version 10 Dec 16 2003 12 55 45 PM Mare EMC NATURAL RESSTANCE Parameter Set Statusi active Based One NATURAL RESISTANCE Therapeutic interpretations Sort fr Loose Prenctype artec 7 7 8 To dapiny Therapeutic interpretations prosa the filer button Ga NCCLS Natur Resistance MC interpretation Therapeutic Wtenpeetaed Figure 11 13 View Therapeutic Guideline 11 16 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Viewing Therapeutic Interpretation Guideline To view the specific Therapeutic Interpretation Guideline information used with the current parameter set 1 Click Filter Figure 11 14 Filter Icon Y Filter Therapeutic Interpretations Select One or More Organisms d eg j Sef Gram positive cocci Gram positive cocci eq Gram negative bacilli Figure 11 15 Select One or More Organisms 2 Toexpand the organism hierarchy double click the selection 3 Select one or more organisms 4 Click the Arrow icon to include them Figure 11 16 Arrow Icon VITEK 2 Systems Software User Manual 11 17 510773 3EN1 Viewing Therapeutic Interpretation Guideline View and Configure AES 5 When you have selected the organism click Next Fitter Therapeutic Interpretations Select One or More Antibioti
237. e row you want to modify 2 Enter a new alphanumeric value in the Text field row 3 Press Enter to accept the change Enabling Patient Demographics Clinical Use Note Patient Demographics is disabled by default This feature allows you to maintain limited patient demographics through the system software The patient demographics that appear on the system software include information added from the Manage Patient Information view Enabling Automatic Daily Backup When this feature is enabled nightly backups of the database can be performed automatically and unattended to a CD The automatic backup will overwrite any previous data backup on the inserted CD 10 10 VITEK 2 Systems Software User Manual 510773 3ENI Configure and Maintain Workstation Viewing Versions of Installed Components Viewing Versions of Installed Components From the Main view you can select Version from the Configuration drop down list to view the currently installed versions of the software components their version numbers and release dates Wi version Infomation of Installed Software Copyright 2002 2004 try bieM rieur inc All rights reserved No part of this publication may be reproduced tennemittedi Irsnseribed or transinted into human language in any form ce by Any metit whatsoever without the previous aprets and written consert of bioM rieux inc This product is licensed to VIE 2 compact VITEK 2 compact Clert MITEK 2 com
238. e soy agar TSAB Trypticase soy agar with 5 sheep blood TSAHB Trypticase soy agar with 5 horse blood TSAL TSA with Lecithin and P80 22 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information Bibliography Bibliography 10 11 12 Balows A Hausler Jr WJ Herrmann KL Isenberg HD Shadomy HJ Manual of Clinical Microbiology 5th edition American Society of Microbiology Washington D C 1991 Barros RR Carvalho GS Peralta JM Facklam RR Teixeira LM Phenotypic and Genotypic Characterization of Pediococcus Strains Isolated from Human Clinical Sources J Clin Microbiol 2001 39 1241 1246 Bille J Catimel B Bannerman E Jacquet C Yersin MN Caniaux Monget D Rocourt J API Listeria a New and Promising One Day System to Identify Listeria Isolates Appl Environ Microbiol 1992 58 1857 1860 Christensen JJ Facklam RR Granulicatella and Abiotrophia Species from Human Clinical Specimens J Clin Microbiol 2001 39 3520 3523 Collins MD Farrow JAE Katic V Kandler O Taxonomic studies on streptococci of serological groups E P U and V description of Streptococcus porcinus sp nov Syst Appl Microbiol 1984 5 402 413 Collins MD Jones D Farrow JAE Kilpper B lz R Schleifer KH Enterococcus avium nom rev comb nov E casseliflavus nom rev comb nov E durans nom rev comb nov E gallinarum comb nov and E malodoratus sp nov Int J Syst Bacteriol 1984 34 220 22
239. e status of the SRF organism to Active 6 14 VITEK 2 Systems Software User Manual 510773 3ENI Maintain Supplemental React File Industrial Use Printing the SRF Biopattern Report Deactivating SRF Organisms To deactivate the SRF organism at any time 1 Select an SRF organism displayed in the list 2 Select Inactive from the Status drop down list 3 Confirm whether you want to deactivate the SRF Organism 4 If you click Yes the SRF Organism becomes deactivated Printing the SRF Biopattern Report When you select the SRF organism from the displayed list you can elect to print the existing SRF Organism and its associated SRF biopatterns 1 From the Maintain SRF Data view select SRF Organisms from the View drop down list 2 Select the SRF organism displayed in the list 3 Select Print to print the selected SRF biopattern report for each SRF biopattern associated with the selected SRF organism 4 The SRF Organism Report view appears 5 Click Print to print the report to the workstation printer 6 Click OK to return to the Maintain SRF Data view VITEK 2 Systems Software User Manual 6 15 510773 3EN1 Printing the SRF Biopattern Report Maintain Supplemental React File Industrial Use SRF Organism Report Industrial Use The SRF Organism report allows you to print information related to the SRF organism and its associated biopatterns W sar Organism Report SRF Organism Report Customer Number Printed by sehle
240. e system software attempts to link the patient with one or more isolates in the active workspace using the Laboratory Identification Number Lab ID The same is true when an isolate is created The system software will attempt to link the isolate with a single patient in the active workspace This linking is not associated with isolates or patient information in the inactive workspace 5 4 VITEK 2 Systems Software User Manual 510773 3ENI Manage Patient Information Clinical Use Linking Isolate and Patient Information When an isolate or a specimen is created modified or deleted as a result of a data management download the isolate and patient information are linked by the Laboratory Identification Number Lab ID of the isolate and the Laboratory Identification Number Lab ID of the specimen If the isolate Lab ID is not found the isolate is flagged as qualified in the View and Maintain Isolate Results view Linking Specimens to an Existing Isolate Note Note When you set up test cards post entry use the Smart Carrier Station or Virtual Cassette workflow follow these steps to link a specimen to an existing isolate 1 Enter the Isolate Information from the Blank Cassette Worksheet For details on setting up tests see Chapter 4 Using the Set Up Tests Post Entry Workflow 2 If Patient demographics is enabled in General Configuration an isolate without patient information will result as a qualified isolate 3 To com
241. e where the instrument determines that the card has not been filled Terminated card no organism suspension detected For the case where the time between two readings is higher than 40 minutes CARD ERROR Missing data For the case where there is a negative profile Organism with low reactivity biopattern please check viability When a biopattern is calculated for an unknown organism that is completely negative or consists of both negative tests and tests that fall within the uncertainty zone the identification call will be Nonreactive biopattern Quality Control NH Product Information The following species could potentially trigger this note if a test was atypical or fell within the uncertainty zone Table 4 4 Non Reactive Species Campylobacter jejuni ssp jejuni Quality Control Quality control organisms and their expected results are located in the VITEK 2 NH Quality Control Tables Process these according to the procedure for test isolates outlined in this document The NH card identifies the quality control organisms as one choice or within a low discrimination or slashline identification See NH Quality Control Tables for more details Frequency of Testing Currently it is recommended that you use your most stringent inspecting agency s guidelines for frequency of identification product testing Common practice is to perform QC upon receipt of shipment of the test kits
242. ealth Service Centers for Disease Control and Prevention National Institutes of Health Office of Health and Safety Biosafety in Microbiological and Biomedical Laboratories 1988 3 22 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Bibliography bioM rieux Inc Use this Product Information with VITEK 2 Product No 21343 CACA bioM rieux Inc bioM rieux sa Box 15969 au capital de 11 879 045 Euros Durham North Carolina 27704 0969 USA 673 620 399 RCS LYON tel 1 800 682 2666 69280 Marcy l Etoile France tel 33 04 78 87 20 00 fax 33 04 78 87 20 90 http www biomerieux com Copyright 2005 bioM rieux Inc All rights reserved VITEK 2 Systems Product Information 3 23 069043 4EN1 Bibliography YST Product Information 3 24 VITEK 2 Systems Product Information 069043 4EN1 NH PRODUCT INFORMATION 4 Intended Use The VITEK 2 Neisseria Haemophilus Identification Card NH is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms The VITEK 2 NH identification card is a single use disposable For a list of claimed species see Organisms Identified by the NH Card starting on page 4 13 Description The NH Card is based on established biochemical methods and newly developed substrates measuring carbon source utilization and enzymatic activities There are 30 biochemical tests Final identif
243. earch 12 7 Typographic Conventions 1 5 U Unassociated SRF Biopattern view 6 5 when creating SRF organism 6 11 Unique Alternative Patient ID 5 3 Unique Patient ID 5 3 Unsaved Data 2 10 Usage Conventions 1 5 User Changes Report 11 22 User Input 1 7 V View AES Graphic 8 9 View and Maintain Isolate Results View approve more than one isolate at a time 8 41 one isolate 8 40 copy ID results to SRF 6 3 export isolate and raw instrument data 8 9 filter by qualified 8 4 show all 8 4 to be approved 8 5 to be reviewed 8 4 information about 2 4 8 3 modify cassette information 4 14 move test cards between isolate groups 8 25 review more than one isolate at a time 8 39 one isolate 8 39 send to SRF 8 9 view AES graphic 8 9 audit history 8 9 card details 8 9 detailed AES report 8 9 test results 8 3 View Audit History of an Isolate 8 27 View BCI Connection Status 12 3 View Card Details AST cards 7 7 8 34 detailed biochemical results 8 9 ID cards 7 7 8 35 print information 8 9 view detailed laboratory report information 8 27 View Card Details Icon 7 7 View Cassette Information 4 5 View Instrument Status 3 2 View Isolate Results by bench 8 4 by isolate 8 4 by patient 8 4 by setup tech 8 4 by their status 8 4 View Patient Information by hospital number 5 2 by patient last name 5 2 View QC Isolate Audit Records 7 6 View Specimen Information Dialog 8 14 View SRF Organism 8 30 Virtual Cassette bar codes for 4
244. ed Sep 23 2003 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 24 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 VITEK 2 technology Figure 13 3 Maintain AST Card Definitions Archive Isolate Reports and Isolate Audit Trail Note 21 CFR 11 must be enabled to create an Archive CD Archiving Isolates The Archive includes Isolate Results LLL ae 13 8 VITEK 2 Systems Software User Manual 510773 3EN1 System Utilities Archive Isolates QC Results Isolate Audit Trail Application Audit Trail The archive workspace is a repository for older tests that have been deleted from the Active Workspace area The time of archiving is determined by application configuration bioM rieux recommends seven days If 21 CFR 11 is enabled all isolates including product and QC isolates must be archived If 21 CFR 11 is enabled all deleted isolates should be included in the archive Archive Isolates VITEK 2 Systems Software User Manual 13 9 510773 3EN1 Only isolates that meet certain criteria can be archived to a CD The following list contains types of isolates eligible for archive Table 13 3 Isolates Eligible For Archive Type of Isolate Status Isolates Test Isolates Final Not Qualified Reviewed Approved Aged from Active Workspace QC Isolates Final
245. ed 2 1 Description ett SES Datel eek ga ate E 2 1 Precautions 25 02 zc y lee den Goede pipi dS 2 1 VITEK 2 Systems Product Information i 532501 3EN1 Table of Contents Storage and Handling 2 2 Specimen Preparation 2 2 MaterjalS ng and and Cette aa ep p n dE RE haus 2 2 Proced re ia ere tes REENEN RAPERE ER 2 5 Results tante en Ex e aie a ERES 2 4 Identification Analytical Techniques 2 4 Identification Card Qualifying Messages 2 5 Percent Probability 2 5 Additional Information on the Lab Report 2 6 Notes associated with certain taxa 2 6 Notes associated with an improperly filled card or with a negative profile biopattern 2 7 Quality Control 2 8 Frequency of Testing 2 8 Testing and Storage of QC Organisms 2 8 Storage Conditions 2 8 GP Quality Control Table 2 9 Limitations wc eee ee EEN p ede E 2 13 Performance Characteristics 2 13 Organisms Identified by the GP Card 2 13 GP Well Contents 2 16 GP Supplemental Tests 2 18 Culture Requirem
246. ed from the active workspace This information can be edited The length of time that the isolate remains in the active workspace is controlled by user configuration For configuration details see Chapter 10 General Configuration Isolates that can no longer be edited are in the inactive workspace The inactive workspace acts as a repository for laboratory reports and QC laboratory reports The inactive workspace is maintained by user configuration VITEK 2 Systems Software User Manual 8 5 510773 3EN1 Using the Navigation Tree to View Specific Isolate Results View and Maintain Isolate Results Expanding and Collapsing the Navigation Tree When using the navigation tree to expand or collapse an individual item click the or or click one of the icons in the left view bar 1 Expand All 2 Collapse All 3 Refresh 4 Search Accession Number 5 Isolate Level 6 Card Level View By solate E Filter By Show All m D Bil 105 1 lt lt Low Discrim z GN Final Nov 26 2003 FE M 106 1 lt lt Low Discrim w D 107 1 Slashlines w M 108 1 lt lt Slashline gt M 109 1 lt lt Low Discrim gt fv 110 1 B firmus fl v 111 1 Pae peoriae El 112 1 lt lt Slashline gt D B 113 1 lt lt Slashline gt BCL Final Nov 26 2003 201 1 Esch coh v 202 1 Entero faecium GP55 Final Nov 26 203 1 Esch coli 204 1 Ps aeruginosa 205 1 Citro freundii 206 1 Staph
247. ed in the YST database Selected species will be added as strains become available Testing of unclaimed species may result in an unidentified result or a misidentification Performance Characteristics In a recent multi site clinical study the performance of the VITEK 2 YST was evaluated using 623 clinical and stock isolates of both commonly and rarely observed species of yeast and yeast like organisms The reference identification was determined with api 20C AUX identification kits Overall the VITEK 2 YST correctly identified 98 6 of the isolates including 11 5 low discrimination with the correct species listed Misidentifications occurred at 0 9 and no identifications occurred at 0 5 Organisms Identified by the YST Card e Candida albicans Candida boidinii e Candida catenulata e Candida colliculosa e Candida dubliniensis e Candida famata Candida freyschussii Candida glabrata Candida guilliermondii e Candida haemulonii Candida intermedia Candida kefyr Candida krusei Candida inconspicua Candida lambica Candida lipolytica e Candida lusitaniae Candida magnoliae Candida norvegensis Data on file at bioM rieux Inc 3 14 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Organisms Identified by the YST Card Candida parapsilosis Candida pelliculosa Candida pulcherrima Candida rugosa Candida sake Candida sphaerica Candida tro
248. ed warranties of MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE bioM rieux shall not be liable for any damages including incidental or consequential damages IN NO EVENT SHALL BIOM RIEUX S LIABILITY TO CUSTOMER UNDER ANY CLAIM EXCEED A REFUND OF THE AMOUNT PAID TO BIOM RIEUX FOR THE PRODUCT OR SERVICE WHICH IS THE SUBJECT OF THE CLAIM Liability Disclaimer bioM rieux 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 bioM rieux without notice and without implying any obligation or liability on the part of the company Intellectual Property bioM rieux the blue logo Advanced Expert System and VITEK are used pending and or registered trademarks belonging to bioM rieux Inc O 2006 bioM rieux Inc All rights reserved Windows XP is a registered trademark of the Microsoft Corporation Adobe and Reader are registered trademarks of Adobe Systems Incorporated CLSI is a trademark of Clinical Laboratory and Standards Institute Inc 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 bioM rieux Inc TABLE OF CONTENTS LIST OF FIGURES aii AEA EEA A AAEE AEE E EA nettes xi LIST
249. ee tata e ee 12 6 Unused Connection sde 12 6 Transaction LOG EE 12 7 Search Button La de dettes 12 8 Delete Button ege dere pelos 12 8 Print BUtON m EEN 12 9 Search B tton E 12 9 Links 12 10 BCI Link ss 12 10 Link Operations Window 12 10 Start Stop Connection EENEG 12 11 Transmission Buttons EEN 12 11 Download BUOM ae AE EE 12 11 LEE 12 12 ele 12 12 Link Operations Submenu History EENEG 12 13 Link Operations Submenu Real Time EENEG 12 14 Link Cohfig ralioh 38588 ttn tcc oue 12 15 Link Configuration Submenu EENEG 12 16 Link Configuration Submenu EENEG 12 16 Connection OK Status eoe ao bc te icone 12 21 Connection Warning Status EENEG 12 21 Connection Error Status EEN 12 21 lec 12 22 Current BCl Alarms erret EES 12 22 VITEK 2 Systems Software User Manual 510773 3EN1 List of Figures Figure 12 30 BCI Alarm History rs 12 23 Figure 12 31 Current BCI Alarms rennes 12 24 Figure 12 32 BCI Alarm History EENEG 12 25 Figure 12 33 BCI Configuration View nr 12 26 Figure 12 34 BCI Configuration View Upload Tab serere 12 28 Figure 12 35 BCI Download Tab nr 12 29 Figure 12 36 BCI Translation Tab dunes 12 30 Figure 13 1 Enter New AST Card Type rene 13 6 Figure 13 2 Delete AST Card Type rene 13 7 Figure 13 3 Maintain AST Card Definitions EE 13 8 Figure 13 4 Archive Isolate Reports and Audit Information 13 10 Figure 13 5 Archive and View Ar
250. eece bioM rieux Hellas S A Papanikoli 70 15232 Halandri Athens tel 30 210 81 72 400 fax 30 210 68 00 880 Hungary Representation Office bioM rieux B V Reitter Ferenc u 39 49 1135 Budapest tel 36 1 412 3880 fax 36 1 412 3890 India bioM rieux India Pvt Ltd D 45 Defense Colony New Delhi 110 024 tel 91 112 464 88 40 fax 91 11 2 464 88 30 Indonesia bioM rieux Asean Enseval Building Kawasan Industri Pulo Gadung JI Pulo Lentut No 10 Jakarta Timur 13920 tel 62 21 461 51 11 fax 62 21 460 41 07 Italy bioM rieux Italia S p A Via Fiume Bianco 56 00144 Roma tel 39 06 52308 1 fax 39 06 52308 240 Ivory Coast bioM rieux Afrique Occidentale 08 BP 2634 Abidjan 08 tel 225 22 40 93 93 22 40 41 40 fax 225 22 40 93 94 Japan bioM rieux Japon Ltd Seizan Bldg 12 28 Kita Aoyama 2 chome Minato ku Tokyo 107 0061 tel 81 3 5411 86 91 fax 81 3 5411 86 90 Korea bioM rieux Korea Co Ltd 7th Floor YooSung Building 830 67 Yoksam dong Kangnam ku S oul tel 82 2 547 6262 fax 82 2 547 6263 Mexico bioM rieux M xico SA de CV Chihuahua 88 col Progreso M xico 01080 D F tel 52 55 5481 9550 fax 52 55 5616 2245 Netherlands The bioM rieux Benelux BV Boseind 15 P O Box 23 5280 AA Boxtel tel 31 411 65 48 88 fax 31 411 65 48 73 New Zealand bioM rieux New Zealand Ltd 22 10 Airbourne Road North Harbour Auckland
251. el for the identification that corresponds to the percent probability value assigned to a given biopattern analysis Tests identified by the Identification Data Analysis Algorithm to be suspect for a particular card result e g a negative result for one or more biochemical with an expected positive value for that given species Generic name for any third party data system Antibiotic results that are not tested on the AST card but the category interpretation is reported based on tested antibiotics and or recognized phenotypes Information about the Patient Sample or Isolate that is being tested Examples include Patient ID Patient Name Specimen source and Accession ID A computer data compilation of any symbol or series of symbols executed adopted or authorized by an individual to be the legally binding equivalent of the individual s hand written signature List of category calls expected for a given antibiotic and given phenotype The list is dependent on interpretation guidelines It can be different from the list of category calls obtained by a comparison of the Interpretation breakpoints to the MIC distribution for the same phenotype and the same antibiotic If there is a potential risk that the resistance conferred by the corresponding resistance mechanism is poorly expressed in vitro this situation can lead to a therapeutic correction proposition ITEK 2 Systems Software User Manual Glossary 3 510773 3EN1 Glossary
252. ement system to download information using a Bi directional Communication Interface application known as BCI see Chapter 12 Configure and Maintain BCI Deleting Specimens If you want to delete a specimen select the specimen in the navigation tree and click Delete Specimen Note If the specimen is the last specimen for a particular patient the software asks you to confirm the deletion of both the patient and the specimen because you cannot have a patient without associated specimens Moving Specimens You can move a Specimen by using the drag and drop technique Click on the specimen in the navigation tree and hold the mouse button down while dragging the specimen to a different patient in the navigation tree Note Be sure to associate the specimen with the correct patient Moving a specimen is typically used when a laboratory technologist incorrectly associates a specimen with the wrong patient Searching Inactive Reports After an isolate associated with a patient specimen has aged the patient information automatically becomes inactive The number of days an isolate will remain in the active workspace before it becomes aged depends on your configuration settings To search for inactive reports 1 From the View and Maintain Patient Information window click Search Inactive Reports 5 6 VITEK 2 Systems Software User Manual 510773 3ENI Manage Patient Information Clinical Use Searching Inactive Reports Figur
253. ems Product Information 069045 2EN1 BCL Product Information BCL Well Contents Table 5 15 BCL Well Contents Well Test Mnemonic Amount Well 47 D TAGATOSE dTAG 0 3 mg 48 D TREHALOSE dTRE 0 3 mg 50 INULIN INU 0 12 mg 53 D GLUCOSE dGLU 0 5 mg 54 D RIBOSE dRIB 0 5 mg 56 PUTRESCINE assimilation PSCNa 0 201 mg 58 GROWTH IN 6 5 NaCl NaCl 6 5 1 95 mg 59 KANAMYCIN RESISTANCE KAN 0 006 mg 60 OLEANDOMYCIN RESISTANCE OLD 0 003 mg 61 ESCULIN hydrolyse ESC 0 0225 mg 62 TETRAZOLIUM RED TIZ 0 0189 mg 65 POLYMIXIN B RESISTANCE POLYB R 0 00095 mg Note Other well numbers between 1 and 64 not designated in this table are empty VITEK 2 Systems Product Information 069045 2EN1 BCL Supplemental Tests BCL Product Information BCL Supplemental Tests Table 5 16 BCL Supplemental Tests Abbreviation Test Name Description Comments Reference 20C Growth at 20 C Ability to grow at 20 C 1 2 2KGa 2 Keto D Gluconate Ability to use 2 keto D 5 6 assimilation gluconate 50C Growth at 50 C Ability to grow at 50 C 1 2 ANA GROWTH Anaerobic growth Ability to grow in the 1 2 6 absence of oxygen CASEIN Casein hydrolysis Ability to decompose 1 2 casein CellChains Cells occurring in Microscopic examination 1 2 6 chains for the presence of bacterial cells forming chains Phase contrast microscopy is recommended dARABINOSE D arabinose Acid produ
254. ens group Salmonella enterica ssp enterica formerly known as Salmonella choleraesuis ssp choleraesuis Salmonella ser Enteriditis Salmonella ser Paratyphi B Salmonella ser Paratyphi C Salmonella spp Salmonella ser Typhimurium Serratia grimesii Serratia liquefaciens Serratia proteamaculans Shigella group Shigella boydii Shigella dysenteriae Shigella flexneri Yersinia enterocolitica group Yersinia aldovae Yersinia enterocolitica Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii VITEK 2 Systems Product Information 1 5 069041 4EN1 Percent Probability Identification Card Qualifying Messages GN Product Information Table 1 2 Identification Card Qualifying Messages ID Message z SE 9 Confidence Level Choices Probability Comments Excellent 1 96 to 99 Very Good 1 93 to 95 Good 1 89 to 92 Acceptable 1 85 to 88 Low Discrimination 2to 3 Sum of choices 2 to 3 taxa exhibit same biopattern 100 after resolution separate by supplemental testing to one choice ith percent probability ust ee to eg wit reflects the number SUSCePtibility card associated with selected choice Unidentified gt 3 n a Either gt 3 taxa exhibit same Organism biopattern or or 0 Very atypical biopattern Does not correspond to any taxon in the database Check Gram stain and purity Percent Probability As part of the identification pr
255. ent CLSI Performance Standards there are no longer interpretative criteria for the following gram negative antimicrobial organism combinations Table 6 5 Organisms without Interpretative Criteria for AST GN Antimicrobials AST GN Antimicrobial Organisms without interpretative criteria Cefixime P aeruginosa and other non Enterobacteriaceae Cefuroxime P aeruginosa and other non Enterobacteriaceae Test results for these combinations should be suppressed Instructions for suppression of results can be found in the online user manual List of Claims Note Ifthe organism is not in the VITEK 2 susceptibility database results will not be reported The following message will appear NOTE Organism not valid for susceptibility testing perform alternate method Gram Negative Organisms Claimed for AST GN keyid Achromobacter denitrificans formerly known as Achromobacter xylosoxidans ssp dentrificans Achromobacter xylosoxidans formerly known as Achromobacter xylosoxidans ssp xylosoxidans Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter genospecies 3 VITEK 2 Systems Product Information 6 31 510774 3EN1 List of Claims Susceptibility Product Information Acinetobacter haemolyticus Acinetobacter johnsonii Acinetobacter junii Acinetobacter lwoffii Acinetobacter spp Aeromonas caviae Aeromonas hydrophila Aeromonas hydrophila caviae Aeromonas sobria Alcaligenes faecalis ssp faecalis B
256. entification Card Qualifying Messages Table 3 3 Identification Card Qualifying Messages ID Message o op 8 Choices Probability Comments Confidence Level Excellent 1 96 to 99 Very Good 1 93 to 95 Good 1 89 to 92 Acceptable 1 85 to 88 Low Discrimination 2to 3 Sum of choices 2 to 3 taxa exhibit same biopattern 100 after Separate by supplemental testing resolution to ith ibili d one choice Must resolve to mate with susceptibility card percent probability reflects the number associated with selected choice Unidentified gt 3 n a Either gt 3 taxa exhibit same biopattern Organism or or 0 Very atypical biopattern Does not correspond to any taxon in the database Check Gram stain and purity 3 6 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Percent Probability Percent Probability Note Note As part of the identification process the software compares the test set of reactions to the expected set of reactions of each organism or organism group that can be identified by the product A quantitative value the percent probability is calculated and relates to how well the observed reactions compare to the typical reactions of each organism A perfect match between the test reaction pattern and the unique reaction pattern of a single organism or organism group would provide a percent probability of 99 When a perfect match
257. ents Table 2 22 Culture Requirements Table Media Abbreviations 2 22 Bibliography 2 23 YST PRODUCT INFORMATION 3 1 Intended Use 3 1 Description c euLbulo ea sise PT AM PEERS 3 1 Pr cautions esse Sota ele ME oie els 3 1 Storage and Handling 3 2 Specimen Preparation 3 2 Materials eee ne EE Dee aay 3 2 Procedure c oe DOE dae a d be UE IER 3 3 Results 554m reme aa weak eg dept e oet ege 3 4 Identification Analytical Techniques 3 4 Identification Card Qualifying Messages 3 6 Percent Probability 3 7 Additional Information on Lab Report 3 7 Notes Associated with Certain Taxa 3 8 ii VITEK 2 Systems Product Information 532501 3ENI Table of Contents Notes Associated with an Improperly Filled Card or with a Negative Profile biopattern 3 8 Quality Control 3 9 Frequency of Testing 3 9 Testing and Storage of QC Organisms 3 9 Storage Conditions 3 9 YST Quality Control Table 3 11 Limitations3 5 io cer Ee E a KR etes 3 14 Performance Chara
258. enzylpenicillin Carbenicillin Mezlocillin Piperacillin Ticarcillin Note Ifthe organism is an Enterococcus or a Staphylococcus species and any antibiotic on the card requires Beta Lactamase beta lactamase is positive then the card will not display SIR category calls until beta lactamase is entered Rule 4 If Beta Lactamase BLA is positive when testing Staphylococcus species Oxacillin OX1 sensitive or not available the results are forced resistant for the following antibiotics Amoxicillin Ampicillin Azlocillin Benzylpenicillin Carbenicillin Mezlocillin Piperacillin Ticarcillin Note Ifthe organism is an Enterococcus or a Staphylococcus species and any antibiotic on the card requires Beta Lactamase beta lactamase is positive then the card will not display SIR category calls until beta lactamase is entered Rule 5 If Salmonella spp or Shigella spp species are tested then the results are forced resistant for the following antibiotics Cephalosporins 1st Cefadroxil Cefalexin B 4 VI Ej ITEK 2 Systems Software User Manual 510773 3ENI Appendix B Forcing Rules Cefalotin Cefazolin Cefradine 2nd Cefaclor Cefamandole Cefonicid Ceftibuten Cefuroxime Sodium Cefuroxime Axetil Aminoglycosides Amikacin Gentamicin Kanamycin Netilmicin Tobromycin Rule 6 If Candida krusei is tested then the results are forced resistant for the following antifungals Fluconazole Global Forcing Rules IMPO
259. eport 1 Click on the Print User Changes Report icon 2 Thereport corresponding to the current workspace appears in a Print Preview view AES User Changes Report Print Preview Hope Hospital AES User Changes Report Printed Jun 14 2004 13 12 Custom Parameter Set Information Copy of NCCLS Natural Resistance tion NCCLS Guideline and Natural Resistance Interpretations NCCLS Natural Resistance BPagetot2 E85x110in Figure 11 22 User Changes Report VITEK 2 Systems Software User Manual 510773 3EN1 CONFIGURE AND MAINTAIN BCI 12 About This Chapter This chapter describes viewing and maintaining the Bidirectional Computer Interface BCI BCI manages system software interface connections with internal or external data management systems such as Laboratory Information Systems LIS Chapter Contents Introduction 12 2 View and Maintain Connection Status 12 2 Supervision 12 4 Status of the Connection 12 5 Alarm Connection 12 6 Unused Connection 12 6 Transaction Log 12 7 Search Transaction Log 12 7 Deleting Transaction Log Messages 12 8 Printing Uploaded Messages 12 9 Link Operation 12 9 Start Stop the Connection 12 10 Transmission of Results Upload 12 11 Reception of Data Download 12 11 Results on Hold Back in Service Out of Service 12 11 View Link History 12 12 Viewing Real time Interface Connection 12 13 Link Configuration 12 14 Tools 12 2
260. eptococcus oralis Streptococcus mutans Streptococcus ovis Streptococcus parasanguinis Streptococcus pluranimalium Streptococcus pneumoniae Streptococcus porcinus Streptococcus pyogenes Streptococcus salivarius Streptococcus sanguinis VITEK 2 Systems Product Information 2 15 069042 5EN1 GP Well Contents GP Product Information Streptococcus sobrinus Streptococcus suis Streptococcus suis Il Streptococcus thermophilus Streptococcus thoraltensis Streptococcus uberis Streptococcus vestibularis Vagococcus fluvialis Staphylococcus aureus claim contains only the subspecies aureus GP Well Contents Table 2 13 GP Well Contents Well Test Mnemonic Amount Well 2 D AMYGDALIN AMY 0 1875 mg 4 PHOSPHATIDYLINOSITOL PHOSPHOLIPASE C PIPLC 0 015 mg 5 D XYLOSE dXYL 0 5 mg 8 ARGININE DIHYDROLASE 1 ADHI 0 111 mg 9 BETA GALACTOSIDASE BGAL 0 056 mg 11 ALPHA GLUCOSIDASE AGLU 0 056 mg 13 Ala Phe Pro ARYLAMIDASE APPA 0 0384 mg 14 CYCLODEXTRIN CDEX 0 3 mg 15 L Aspartate ARYLAMIDASE AspA 0 024 mg 16 BETA GALACTOPYRANOSIDASE BGAR 0 00204 mg 17 ALPHA MANNOSIDASE AMAN 0 036 mg 19 PHOSPHATASE PHOS 0 0504 mg 20 Leucine ARYLAMIDASE LeuA 0 0234 mg 23 L Proline ARYLAMIDASE ProA 0 0234 mg 24 BETA GLUCURONIDASE BGURr 0 0018 mg 25 ALPHA GALACTOSIDASE AGAL 0 036 mg 26 L Pyrrolydonyl ARYLAMIDASE PyrA 0 018 mg 27 BETA GLUCURONIDAS
261. er VITEK 2 Systems Product Information 6 14 510774 3EN1 Performance Characteristics Susceptibility Product Information 6 15 PI TT M RCE ess een ei 9 56 34 sn XZ SUIIXOZIYSD S76 34 sn ZVD auipizeya gt E ub en ad aWIxopodjay Pe eo oo se es ITT dd ess epe pm Jee o o ea fo aal ees apo wey uowwo u w 13y Alo aje u w 18y jenu ssq LSV oAneSoN WeLID JOJ sonsuojeleu DDULUWOJ d VITEK 2 Systems Product Information 510774 3EN1 1SV M N Wes 10 SYSH PLILYJ DIUPULJOJJOd JUHA ds JEIGOHIUHUV Z AILA T 9 9 qer Susceptibility Product Information Performance Characteristics sz soj sij vs so oo ei ns 2 mo mi seg sz soj oo se oo oof oof ces aal elei eem 1953 sewepe ejag uinnpedg V N TT L L6 34 IsID 18S3 pepueix3 esp ef ef of ew NTI NITI ees Tess oa vs ew sall rev 9 me EIKCIKCINZIRCICINCTNCI NNI ns el esp oo ss sof oo mem sel e em KINO KI EI INCI ales Jee KUNCI CI wef oe of eee el gt meme pe Rp fm wi RI fm sms CEE eee Que sa ee wo n coe orl ee now se KI om sw am awn vow aw am awn van apo wey uowwo u w 13y A1030 e5 u w 18y Jenuoess3 LSV oAneSoN WeID JOJ SISHA PeIeYD e ueuuojled 1SV M N Wes 10 SYSH PLILYJ D2UPULJOJJOd JUHO ds JEIGOHIUHUVW Z AILA T 9 9 qer VITEK 2 Systems Product Information 6 16 510774 3EN1 Performance Characteristics Susceptibility Prod
262. er Manual 510773 3ENI View and Maintain Isolate Results Access the Isolate Results View Access the Isolate Results View From the View and Maintain Isolate Results view you can browse through the isolate results The isolate results are available in the navigation tree in a navigation tree structure The results are organized by isolate groups You can easily browse through the isolate results using the left view buttons to select the order of appearance for isolate groups in the navigation tree To access this view 1 From the Main view click Enter Isolate View Main View Nk mizi xi VITEK 2 technology VITEK 2 technology Figure 8 1 Enter Isolate View Icon VITEK 2 Systems Software User Manual 8 3 510773 3ENI Using the Navigation Tree to View Specific Isolate Results View and Maintain Isolate Results 2 The View and Maintain Isolate Results view appears VW View and Maintain isolate Results AES Findings Consistert Phenotypes Selected for Review DJ GLYCOPEPTLES RESISTANT VAN ALKE RESISTANT VAN D LKE v 101 1 Esch ceh ONFinsi iov 26 2003 1024 firtero tecate T v 10341 Str pneumoniae 9 v 106 4 pen Analysis Staus 11 0 Pr Fri B 105 1 Lov Derim Analyste Messages orcaniss not valid for eeptibility testing Perform ternate method B 109 1 eu or Drenken Icenttewcin High Level syne Levoton Tenzypencan Nortonscin i Streptomyci
263. era 2 Unused Unused FS g s odo d n oso Figure 12 24 Link Configuration Submenu 12 16 VITEK 2 Systems Software User Manual 510773 3EN1 Link Configuration Configure and Maintain BCI The following table describes each configuration setting and gives the possible values and default values for each one Table 12 1 Configuration Parameters Parameters Description Possible Values Default Name of the link Name of the LIS Any name is valid except Unused Note You must enter a name for the default value Limit the LIS and you cannot use a of 32 characters name that is already in use Important Do not change the port name to Unused You must stop the port and reset it in BCI to revert the port to Unused Description Free entry Free entry Limit of 32 Blank characters Protocol Choose between the following bioM rieux Literal bioM rieux Literal This is a proprietary Literal data transfer protocol developed by bioM rieux used to transfer information between computers Manual bioM rieux Literal alternate Kermit Literal Alternate Same as Literal except all messages are dealt with after reception of the lt ETX gt character Kermit A file transfer and terminal emulation program developed to transfer asynchronous files between computers Manual This is a tool that helps set up the connection with the LIS BMX configuration Delays Last Maste
264. es of this genus are difficult to maintain Testing and Storage of QC Organisms Rehydrate organism according to the manufacturer s instructions Streak organism to SDA Incubate for 18 to 24 hours All QC Organisms are incubated at 35 C to 37 C except Prototheca wickerhamii ATCC 16529 which is incubated at 28 C to 30 C Check for purity Perform second subculture for testing Streak organism to SDA Incubate for 18 to 24 hours Storage Conditions VITEK 2 Systems Product Information 3 9 069043 4EN1 Short Term Storage 1 Streak to a SDA plate or slant 2 Incubate for 24 hours at the appropriate temperature Quality Control YST Product Information 3 Refrigerate at 2 C to 8 C for up to two weeks 4 Subculture once as described above and use for QC Long Term Storage 1 Make a heavy suspension in Tryptic Soy Broth with 15 glycerol 2 Freeze at 70 C 3 Subculture to SDA twice before running QC Note Avoid repeated thawing and refreezing by either freezing in single use aliquots or removing a small portion of frozen organism preparation with a sterile applicator stick 3 10 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information YST Quality Control Table YST Quality Control Table Candida glabrata ATCC MYA 2950 Candida lusitaniae ATCC 34449 Candida utilis ATCC 9950 Geotrichum capitatum ATCC 28576 Kloeckera apis ATCC 32857 Prototheca wickerhamii
265. est Cards View and Maintain Isolate Results 6 Enter or select a new Setup Tech and make any necessary changes Note If 21 CFR 11 is enabled the Setup Technologist cannot be changed 7 The following information is read only Bionumber Contraindicating tests Supplemental tests 8 The system software updates the organism quantity for the card or all cards in the selected isolate group and performs the necessary re analysis 8 16 VITEK 2 Systems Software User Manual 510773 3ENI View and Maintain Isolate Results Modifying Isolate Groups and Test Cards Confirm Changes to the Isolate Group Results become Final Depending on the Result Validation configuration when making changes to the isolate information you may be prompted to add change comments Depending on the state of the isolate the Supervisor who made the change may be required to complete the approval process The following information defines when change comments and Supervisor approval are needed Review Only 1 step process all isolates Needs Reviewed gt Customer gt Change gt Send to LIS Review Supervisor or Makes a Comments Lab Tech Change Required Supervisor Review and Approve p Needs gt Reviewed Customer Change 2 step process all isolates Review Makes a Comments Change Required gt Needs Approved Change Customer Send to LIS Review Supervi
266. estis Notes Associated with Improperly Filled Card or Negative Profile biopattern For the case where the instrument determines that the card has not been filled Terminated card no organism suspension detected For the case where the time between two readings is higher than 40 minutes CARD ERROR Missing data For the case where there is a negative profile Organism with low reactivity biopattern please check viability When a biopattern is calculated for an unknown organism that is completely negative or consists of both negative tests and tests that fall within the uncertainty zone the identification call will be Nonreactive biopattern 1 8 VITEK 2 Systems Product Information 069041 4EN1 GN Product Information Quality Control The following species could potentially trigger this note if a test was atypical or fell within the uncertainty zone Table 1 4 Non Reactive Species Acinetobacter haemolyticus Acinetobacter lwoffii Actinobacillus ureae Aeromonas salmonicida Brucella melitensis Francisella tularensis Methylobacterium spp Moraxella lacunata Moraxella nonliquefaciens Moraxella osloensis Pasteurella multocida Pseudomonas alcaligenes Pseudomonas fluorescens Pseudomonas stutzeri Quality Control Quality control organisms and their expected results are listed in the VITEK 2 GN Quality
267. etails view ID details record lot shipments and review and approve quality control results For details see Chapter 7 Maintain Customer Quality Control Configuration k The Configuration views allow you to view configuration parameters Supervisors can unlock and modify the configuration parameters For details see Chapter 10 Configure and Maintain Workstation System Utilities System Utilities views allow you to create new AST card definitions search audit history archive and view archived isolate reports For details see Chapter 13 System Utilities Note Back up and restore data are external to the system software for details see Chapter 14 Data Backup and Daily Maintenance VITEK 2 Systems Software User Manual 2 5 510773 3EN1 Accessing the System Software Getting Started Accessing the System Software After you become familiar with the navigation elements of the system software the next step involves accessing the application and navigating through each view The following sections describe accessing the system software Starting the System Software Logging In Logging Out or Quitting the System Software Changing Users Manage Inactivity Timer Starting the System Software If your workstation computer is turned on and the system software has already been installed follow these steps to start the application 1 From the Start menu select P
268. ete system for routine identification testing of aerobic endospore forming organisms of the family Bacillaceae Required materials are VITEK 2 BCL Card VITEK 2 DENSICHEK VITEK 2 DENSICHEK Power Adapter Lithium Battery for DENSICHEK DENSICHEK Calibrator VITEK 2 Cassette Sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 12x 75 mm clear plastic polystyrene disposable test tubes Sterile sticks or swabs Appropriate agar medium See Culture Requirements Table on page 5 23 Optional accessories Saline Dispensers Pre dispensed saline test tubes aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 Test tube caps Vortex Note For product specific information see Culture Requirements Table on page 5 Prepare the inoculum from a pure culture according to good laboratory practices In case of mixed cultures a re isolation step is required It is recommended that a purity check plate be done to ensure that a pure culture was used for testing 1 Select isolated colonies from a primary plate if culture requirements are met VITEK 2 Systems Product Information 5 3 069045 2EN1 Results BCL Product Information Results or Subculture organism to be tested to appropriate agar medium and incubate accordingly 2 Aseptically transfer 3 0 mL of sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 into a clear plastic polystyrene test tube 12 x 75 mm
269. ew contains the following information about the user defined connections Supervision Provides the global status on each link Transaction Log Displays the history of transactions and allows the user to see what isolates have been uploaded over time Link Operation Provides detailed upload and download activity on a particular connection Link Configuration Displays the parameter screen for each connection Tools Allows you to print restore and save a configuration Note To maintain BCI status you must be a Supervisor or an Administrator of the system software 12 2 Vi ITEK 2 Systems Software User Manua 510773 3EN1 View and Maintain Connection Status Configure and Maintain BCI Once BCI is configured you can click View BCI Status to view the current connection status for the defined interfaces 1 To access the BCI Status screen click on the BCI Alarm and Status icon located at the bottom left of any screen within the system software Figure 12 1 BCI Connection Status 2 From within the BCI Status and Alarm view click View BCI Status 3 The software prompts you to enter your User Name and Password 4 The BCI Status window appears 5 Navigate to one of the following options to maintain the interface connections Supervision see Supervision on page 12 4 Transaction Log see Transaction Log on page 12 7 Link Operation see Link Operation on page 12 9 Link Config
270. f Results Upload When the green left arrow is selected the transmission of results to the external data management computer is enabled the corresponding status indicator light U is green Select the red arrow to disable transmission and the status indicator U changes to red Figure 12 16 Transmission Buttons Reception of Data Download When the green arrow is selected the reception of data from the external data management computer is enabled and the corresponding status indicator light D is green Select the red arrow to disable the reception of data patient and specimen information and the status indicator D changes to red 4 Figure 12 17 Download Button Results on Hold Back in Service Out of Service CAUTION Use of BIS and OOS functions is typically automated by A the LIS Refer to the LIS connection protocol or for further information contact the bioMerieux Global Customer Support VITEK 2 Systems Software User Manual 12 11 510773 3EN1 Configure and Maintain BCI Link Operation The BIS button green appears pressed down when the external data management computer is receiving upload from the bioM rieux computer BIS 008 Figure 12 18 BIS The OOS button red appears pressed down when results are not being uploaded to the external data management computer The bioM rieux computer will not attempt to upload to an external data management computer in this state BIS 005 Figure 12 19
271. f trehalose UREASE Urease Hydrolysis of urea releases 2 5 5 ammonia resulting in alkalinization of the medium observed with a pH indicator e g red color formation in the presence of phenol red dXYLOSEa D XYLOSE Assimilation Ability to use xylose as the 2 5 5 sole carbon source QW WED A Comer Dol IN namaka 3 20 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Culture Requirements Table Culture Requirements Table Table 3 15 Culture Requirements Manual Age of VITEK 2 S Age of Incubation Inoculum tS Suspension Media em 3 Dilution s Card Culture Conditions Density Before Loading for AST Instrument YST SDA 18 to 72 30 C to 37 C 1 80 to 2 20 N A lt 30 minutes TSAB hours aerobic non CO McFarland CBA or 25 C to 30 C Standard for species that do IMA not tolerate 30 C to TSA 37 C CHBA CPS ID3 YST and SDA 18 to 72 35 C to 37 C 1 80 to 2 20 280pL in lt 30 minutes AST YST Pair rcAp hours aerobic non CO McFarland 3 0 mL Standard saline CBA TSA CHBA CPS ID3 These media were used in the identification product database development and will give optimal performance Culture Requirements Table Media Abbreviations CBA Columbia sheep blood agar CHBA Columbia Horse blood agar CPS ID3 CPS ID3 Agar IMA Inhibitory mould agar SDA Sabouraud dextrose agar TSA Trypticase soy agar TSAB Trypt
272. fines each card in the cassette Wsetup Tests Post Entry Se Cep zemmer Figure 4 5 Card Definition The following columns define the cards in the selected cassette Slot VITEK 2 Systems Software User Manual 4 7 510773 3ENI Defining the Selected Cassette Set Up Test Cards and Cassette Information QC Quality Control Card Card Type Bar code Accession Laboratory ID number plus the Isolate number Organism Offline Test Message Instrument Message Org Qty Organism Quantity Entering Cassette Worksheet Information When the cassettes are loaded into the instrument the instrument scans the card bar codes providing an automated method for entering most of the test setup information into the system software However you still need to enter information from the Blank Cassette Worksheet to completely process the cards 1 2 3 4 5 6 Select a newly loaded cassette from the displayed list in the navigation tree The cassette appears in the cassette workspace Each cassette contains card information for the cards in each slot Ten slots appear numbering each card in the cassette This column is read only The card type that was scanned by the instrument appears in the Card Type column This column is read only The last four digits of the card bar code appear in the bar code column This column is read only Enter the Accession or Accession ID Laboratory Identification
273. g QC Comments 1 Select the QC isolate you want to update 2 Make the changes in the QC Comments field on a selected test 3 The system software updates the QC Isolate Group in the QC active workspace and adds the comment to the test If the isolate is in the QC Cumulative workspace and you add a comment then the QC test in the cumulative workspace is updated A QC isolate is added to Cumulative after it is complete for example Reviewed or Reviewed Approved Changing the QC Reference ID To change the QC Reference ID 1 From View QC Results view select the card that you want to change 2 Select the new QC Reference ID 3 The system software updates the expected organism name and performs the required analysis based on the selected card type Changing the Setup Technologist s Name If 21 CFR 11 Compliance Mode is not enabled you can change the Setup Technologist name that appears in the field For information on enabling 21 CFR 11 Compliance mode see Chapter 10 General Configuration Select a name from the list in the Setup Technologist field The system software is updated to reflect the change Note If 27 CFR 11 Compliance Mode is enabled you cannot change the name of the Setup Technologist The Setup Technologist is the user logged into the system software when the cassette is loaded into the instrument Viewing QC Isolate Audit Records Supervisor Only When you elect to view audit records for a QC isolate the life
274. ganii Morganella morganii ssp morganii Morganella morganii ssp sibonii Myroides spp Pantoea agglomerans Pantoea dispersa Pasteurella aerogenes Pasteurella multocida Pasteurella pneumotropica Plesiomonas shigelloides Proteus mirabilis Proteus penneri Proteus vulgaris group Proteus vulgaris group Proteus penneri Providencia alcalifaciens Providencia rettgeri Providencia rustigianii Providencia stuartii Pseudomonas aeruginosa VI S 6 33 ITEK 2 Systems Product Information 510774 3EN1 List of Claims Susceptibility Product Information Pseudomonas aeruginosa ATCC 27853 Pseudomonas alcaligenes Pseudomonas fluorescens Pseudomonas luteola Pseudomonas mendocina Pseudomonas oryzihabitans Pseudomonas pseudoalcaligenes Pseudomonas putida Pseudomonas spp Pseudomonas stutzeri Psychrobacter phenylpyruvicus Ralstonia pickettii Raoultella ornithinolytica Raoultella planticola Raoultella terrigena Salmonella enterica ssp arizonae formerly known as Salmonella choleraesuis ssp arizoniae Salmonella enterica ssp enterica formerly known as Salmonella choleraesuis ssp choleraesuis Salmonella ser Enteritidis Salmonella group Salmonella ser Paratyphi A Salmonella ser Paratyphi B Salmonella ser Paratyphi C Salmonella spp Salmonella ser Typhi Salmonella ser Typhimurium Serratia ficaria Serratia fonticola Serratia grimesii Serratia liquefaciens Serratia liquefaciens group Serratia marcescens Ser
275. gical Risks 1 10 VITEK 2 Systems Software User Manual 510773 3ENI How to Use This Manual Fe pp IVD LOT sli VITEK 2 Systems Software User Manual 510773 3EN1 Table of 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 Table of Symbols NaN x 3 CONTROL Ne AIN om A How to Use This Manual Do Not Reuse Recyclable 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 VITEK 2 Systems Software User Manual 510773 3ENI How to Use This Manual VITEK 2 Systems Software User Manual 510773 3EN1 Table of Symbols 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 OFF Supply ON Only for a Component of the System Equipment Table of Symbols How to Use This Manual OFF Only for a Component of the System Equipme
276. graphy Susceptibility Product Information 6 40 VITEK 2 Systems Product Information 510774 3ENI
277. hat match closest to your search criteria appear in the Search for Inactive Reports window 5 Select and or scroll to select from the list of results and select the result you want to view VITEK 2 Systems Software User Manual 5 7 510773 3EN1 Searching Inactive Reports Manage Patient Information Clinical Use 6 Choose the report format that you wish to display by selecting a report option Lab Report Default AES Detail Report vale ener LALC NE fe Lab Report i AES Detel Report Patient ID Figure 5 7 Inactive Reports Format Options 7 Click Preview to display the inactive report and view the details 8 Click Print to print the report to the workstation printer Printing Reports To print lab reports for isolates aged from the active workspace follow these steps 1 From the Search Inactive Reports window click Preview to preview the report based on your search criteria 2 The Preview Report window appears 3 Click Print to print the report to the workstation printer 5 8 VITEK 2 Systems Software User Manual 510773 3ENI MAINTAIN SUPPLEMENTAL REACT FILE INDUSTRIAL Use 6 About This Chapter This chapter introduces and describes maintaining the supplemental reaction file SRF Chapter Contents Introduction to SRF Industry Use 6 2 Copy Biopatterns to SRF 6 2 Criteria for Merging ID Results with SRF Results 6 4 Creating and Maintaining SRF Organisms Supervisor 6
278. heck the saline level in the tubes after the vacuum fill Give special consideration to specimen source and patient drug or antimicrobic regimen Interpretation of test results requires the judgment and skill of a person knowledgeable in microbial identification testing Additional testing may be required NH Supplemental Tests on page 4 17 WARNING As All patient specimens and microbial cultures are potentially VW infectious and should be treated with universal precautions 11 12 Storage and Handling Upon receipt VITEK 2 NH Cards must be stored unopened in their original package liner at 2 C to 8 C Specimen Preparation For specimen preparation information see the Culture Requirements on page 4 20 4 2 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information Materials Materials When used with VITEK 2 instrumentation the NH Card is a complete system for routine identification testing of most significant fastidious organisms Required materials are VITEK 2 NH Card VITEK 2 DENSICHEK VITEK 2 DENSICHEK Power Adapter Lithium Battery for DENSICHEK DENSICHEK Calibrator VITEK 2 Cassette Sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 12x 75 mm clear plastic polystyrene disposable test tubes Sterile sticks or swabs Appropriate agar medium See Culture Requirements on page 4 20 Optional accessories Saline dispensers
279. iations Table 8 8 Report Contents Isolate Report Sections ID and AST ID Summary and AST Details includes AES if enabled Only ID test ID Details Only AST test ID Summary AST Details includes AES if enabled The following information is repeated on each page Laboratory Information Number and Isolate number or Accession ID Chart Report Patient Name if enabled Patient Identification number if enabled Patient location Chart Report Only Name of physician Chart Report Only Version number if 21 CFR 11 is enabled Isolate Bench Lab Report Only if enabled Date time last modified if 21 CFR 11 is enabled Note f AES is enabled AES changes and user changes are visually flagged and antibiotics that were deduced will have a sign in front of them Note Suppressed antibiotics from within results management or user configuration are not printed on the Chart Report On a Lab Report if electronic signature is enabled the last section of the report contains the following information User ID 8 32 VITEK 2 Systems Software User Manual 510773 3ENI View and Maintain Isolate Results Printing Result Reports User Name Action reviewed or approved Date time completed Change comment On a Lab Report if AES is enabled the bottom of each page of the Lab Report contains the following MIC Interpretation Guideline Therapeutic Interpretation Guideline AES
280. ib1 System Number Printed Get 8 2003 1750 SRF Organism Detail SRF Organism Code otsp Status of SRF Organism Inactive SRF Organism Name Citrobacter species Card Type associated with SRF Organism GN Comment Associated Biopattern Detail Small with feather 7806384463160100 Negative Rods ledge S Large spready kenen Variable poss m DPagetof M85xttin Lal Figure 6 15 Example SRF Organism Report 6 16 VITEK 2 Systems Software User Manual 510773 3EN1 MAINTAIN CUSTOMER QUALITY CONTROL 7 About This Chapter This chapter describes maintaining customer Quality Control QC Chapter Contents Introduction to Working with QC Results 7 2 Viewing QC Results 7 2 Viewing Selected QC Results 7 3 Creating a Custom Filter to View Cumulative QC Information 7 4 Adding or Modifying QC Comments 7 5 Changing the QC Reference ID 7 5 Changing the Setup Technologist s Name 7 5 Viewing QC Isolate Audit Records Supervisor Only 7 5 Viewing Card Details 7 6 Reviewing QC Results 7 7 Approving QC Results Supervisor Only 7 8 Applying Electronic Signature 7 8 Creating and Viewing Batch Results 7 9 Batch Review and Approve 7 11 Recording Shipments 7 11 Printing QC Laboratory Reports 7 14 VITEK 2 Systems Software User Manual 7 1 510773 3EN1 Introduction to Working with QC Results 7 2 Maintain Customer Quality Control Introduction to Work
281. icase soy agar with sheep blood VITEK 2 Systems Product Information DT 069043 4EN1 Bibliography YST Product Information Bibliography 1 Atlas RA Handbook of Microbiological Media CRC Press Ann Arbor 1993 2 Barnett JA Payne RW Yarrow D editors Yeasts Characteristics and Identification 3 ed Cambridge University Press New York 2000 3 Kreger van Rij NJW editor The yeasts a taxonomic study 3 4 ed Elsevier Science Publishers B V Amsterdam 1984 4 Larone DH Medically Important Fungi a guide to identification 3 4 ed ASM Press American Society for Microbiology Washington D C 1995 5 Lodder J The Yeasts Second Edition North Holland Publishing Company Netherlands 1971 6 McGinnis MR Laboratory Handbook of Medical Mycology Academic Press New York 1980 7 Murray PR Baron EJ Pfaller MA Tenover FC Yolken RH editors Manual of Clinical Microbiology 7 Edition American Society for Microbiology Washington D C 1999 8 National Committee for Clinical Laboratory Standards M29 A Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline 1997 9 Pincus DH Salkin IF Hurd NH Levy IL Kemna MA Modification of Potassium Nitrate Assimilation Test for Identification of Clinically Important Yeasts J Clin Microbiol 1988 26 366 368 10 U S Department of Health and Human Services Public H
282. ication results are available in approximately six hours For a list of well contents see NH Well Contents starting on page 4 15 Precautions For In Vitro Diagnostic Use Only Suspensions not within the appropriate zone on the VITEK 2 DENSICHEK may compromise card performance Do not use the card after the expiration date shown on the package liner Store the card unopened in the package liner Do not use the card if the protective package liner is damaged or if no desiccant is present Allow the card to come to room temperature before opening the package liner Do not use powdered gloves Powder may interfere with the optics Use of culture media other than the recommended types must be validated by the customer laboratory for acceptable performance The card performs as intended only when used in conjunction with VITEK 2 Systems Do not use glass test tubes Use clear plastic polystyrene tubes only Variation exists among test tubes of standard diameter Carefully place the VITEK 2 Systems Product Information 4 1 532511 4EN1 Storage and Handling NH Product Information tube into the cassette If resistance is encountered discard and try another tube that does not require pressure to insert Ensure that cards are filled properly and do not load any cards that are filled improperly Prior to inoculation inspect cards for tape tears or damage to the tape and discard any that are suspect C
283. ick Export Results Figure 13 9 Export Results Icon Note If a CD is not already inserted a message appears asking you to insert a blank CD 3 After you insert the CD the system software validates the CD and copies the isolate audit report to a CD 13 16 VITEK 2 Systems Software User Manual 510773 3ENI System Utilities Print Audit Trail Reports Print Audit Trail Reports An Audit Trail report allows you to print isolate and application audit information To print the audit trail information click the Print icon To search the audit database see Search Audit Trail on page 13 13 Search Audit Trail Searched Search Type 7 Isolate C application System Labi Isolate Audit Report Customer Number Printed by schleibt Isolate Number System Number Printed Oct 8 2003 1738 Search Criteria Lab ID lt all gt gt Isolate Number lt all gt gt QC Reference ID lt lt all gt gt User ID Recorded lt lt all gt gt Event Type lt lt all gt gt Source Database Start Date lt lt all gt gt End Date alb Audit Trail Events lapr 26 2003 1719 303 1 Crmedisoite ect is 0107777770777041 er 28 2003 1719 393 1 e busehdi 2 Made a mistake 0107777770777041 Archivediisolate Active Archived sol er 28 2003 1719 ooi ed System hts aped 0107777770777041 Created Isolate Created Oct 2 2003 1224 03 2 schleibt Modified Analysis et 2 2003 1228 1044 eer
284. ics and Procedures Typographic and Usage Conventions VITEK 2 Systems Software User Manual 1 3 510773 3EN1 Chapter Organization How to Use This Manual How This Manual Is Organized There are four basic parts to this manual Part I Introduction and Getting Started Introduces the new system and its components and gives quick start information for using this software application Part II Set Up and Manage Test Information Describes setting up and managing tests patients and quality control information Part Ill View and Maintain Results Describes viewing modifying and finalizing isolate results Part IV Configure the Workstation and Maintain System Utilities Provides instructions for laboratory technologists and supervisors on how to administer the system generate reports archive data and restore the system Chapter Organization All of the workflow and procedural chapters are organized in the same way and include the following About This Chapter Brief description of the chapter s content and where applicable an explanation of how to access the menu or menu command that is the subject of the chapter Chapter Contents A table of contents for the chapter Procedures Background Information where applicable and useful Finding Topics and Procedures This manual uses several methods to help you find information and keep your bearings Table of Contents Located at the fro
285. idation and interpretation of AST results is suspended until all of your changes are saved or you exit the Customization unlocked mode If the inactivity timer is exceeded the results restart and are no longer suspended for customization Any saved changes are applied to the results and any unsaved changes are no longer available Parameter Set Information The AES Configuration view allows you to view predefined or standard parameter sets A parameter set is a collection of parameters that you can use to customize the validation and interpretation process within AES Within this collection there are two very importance parameters MIC Interpretation guideline Defines a set of breakpoints Therapeutic Interpretation guideline Defines the therapeutic interpretations The parameter sets appear in the navigation tree in the AES configuration view 11 4 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Parameter Set Information Note The default active parameter set is CLSI Natural Resistance The following predefined or standard parameter sets are available CA SFM Phenotypic CA SFM breakpoints with Phenotypic Therapeutic Interpretations e Global CLSI Consists of Global CLSI CA SFM or Manufacturer breakpoints with CLSI Therapeutic Interpretation Changes e Global Natural Resistance Consists of Global CLSI CA SFM or Manufacturer breakpoints with CLSI and Natural Re
286. iew select the ID results that you want to copy to SRF and click Send to SRF Figure 6 2 Send to SRF Icon 2 Aconfirmation window appears asking you to confirm copying this biopattern to SRF Click Yes to copy the biopattern VU confirm Do you want to copy the selected isolate to SRF Figure 6 3 Copy Biopattern Window VITEK 2 Systems Software User Manual 6 3 510773 3EN1 Copy Biopatterns to SRF Maintain Supplemental React File Industrial Use 3 The following isolate information is recorded in the local SRF database as an SRF Biopattern Card type Bionumber Biopattern biochemicals and reactions Organism Name Card bar code Accession ID User ID user who copied Biopattern to SRF Date copied to SRF Note Ifthe card bar code has already been entered an informational message appears and the system does not update SRF 4 Toview the SRF Organism go to the Maintain SRF Data window For more details see Creating and Maintaining SRF Organisms Supervisor on page 6 5 Criteria for Merging ID Results with SRF Results The criteria for copying biopatterns to the database depends on the needs of your individual laboratory Any of the following ID Analysis Results may be copied to SRF Unidentified Single Excellent Identification Low Discrimination Slashline 6 4 VITEK 2 Systems Software User Manual 510773 3ENI Maintain Supplemental React File Industrial Use Creating and
287. iew unlock the view to make changes Select the Antibiotics to Suppress tab Select the Add an Organism icon A window appears displaying an organism list Select an organism and click OK Click Edit A window appears displaying antibiotics to suppress Select the antibiotics to suppress and click OK Note Be sure to save and lock your changes before moving on to the next view Results Validation Configuration Configure Results Analysis and Review Results Validation Configuration Critical Isolates Result Validation Configuration involves configuring results for review or approval allowing for batch review and approval and or enabling electronic signature If AES is enabled result validation configuration also includes selecting organism phenotype combinations to stop for review enabling review of MIC Corrections and review of Therapeutic Interpretations After the workstation software has analyzed the test card readings isolates with the characteristics noted in the following table will be categorized as Critical Note Critical Isolates must be complete and must have no other qualifying results Isolates with one or more of the following characteristics are considered Critical Isolates and are flagged for review Table 9 1 Critical Isolates Analysis Problem Description ID Card Analysis Problems Organism result is Unidentified Analysis indicates an unfilled ID card ID card status is Termin
288. iew at this point Click Review 7 10 VITEK 2 Systems Software User Manual 510773 3EN1 Maintain Customer Quality Control Batch Review and Approve If the status of all of the selected results is To Be Approved you can perform a batch approve by clicking Approve Batch Review and Approve If Batch Review is enabled in the system software configuration settings you can review batches of more than one isolate at the same time 1 Create a batch of isolate groups to identify as Reviewed 2 Click Review 3 Confirm whether or not you want to flag all of these isolates as Reviewed 4 Confirm whether you want to print QC Lab Reports 5 Depending on your results validation configuration the following may occur If system software is configured based on the default settings Review All Isolates The system software flags the QC isolates as Reviewed The QC Isolate icon changes to green The system software transfers the QC isolates into the QC cumulative workspace for long term storage If system software is configured for Review and Approve The system software flags the isolate as To Be Approved the QC Isolate icon changes to the To Be Approved icon 6 If an Electronic Signature is needed you are prompted to enter your User ID and Password to review or approve the results Note The user who reviews the results cannot be the same user who approves the results 7 The isolate groups are flagged as Rev
289. iew in active workspace 11 11 MIC Value 8 19 Modify all cards in an isolate group 8 10 breakpoints of the MIC interpretation guideline 11 12 cassette information 4 14 configuration settings 2 5 10 5 10 4 identification settings in ID configuration view 9 2 inactivity timer 2 10 10 7 QC comments 7 5 N Navigation from main view 2 5 from navigation bar 2 5 softview views 2 5 system software 2 2 Navigation Tree collapse all items 8 6 expand all items 8 6 refresh items 8 6 results status icons 8 6 view specific test results from 8 4 Needs Info Status 4 5 New Card Shipments 4 24 0 Offline Tests 4 9 Operating System User Manual 13 3 Organism Quantity on cassette worksheet 4 8 select new 8 15 Organism Short Name 4 8 Organization chapters 1 4 VITEK 2 Systems Software User Manual 510773 3EN1 Index 7 Index this manual 1 4 Parameter Set activate new parameter set 11 8 active parameter set guidelines 11 8 AES 11 4 associated custom interpretation guidelines 11 11 confirm deletion of MIC guidelines 11 11 set 11 11 therapeutic interpretation guidelines 11 11 custom set delete 11 11 customize MIC interpretation guideline 11 12 information about 11 8 MIC guidelines for 11 11 name 11 10 new interpretation guideline name 11 13 predefined 11 12 view status 11 15 11 19 Patient Demographics enabled in general configuration 5 5 Patient Information alternative unique ID 5 3 downloaded 5 6
290. iewed Recording Shipments Approximately once or twice a month you may need to record a shipment of new ID or AST cards You can record a shipment using the system software VITEK 2 Systems Software User Manual 7 11 510773 3EN1 Recording Shipments Maintain Customer Quality Control A shipment can consist of more than one card type and can contain cards from more than one lot production run Cards from a specific lot may be sent in one or multiple shipments The individual boxes of cards contain cards of one card type only all from the same lot Each box has a bar code imprinted on it which contains the lot number lot expiration date and card type A box can have more than one bar code imprinted on the box To record a shipment of cards you must enter the following information into the system software Lot number Date of receipt Quantity of boxes in the shipment optional To add the QC shipment information to the system software 1 From the View QC Results view click the Record Shipment icon Figure 7 8 Record Shipment Icon 2 The Record Shipments window appears 7 12 VITEK 2 Systems Software User Manual 510773 3ENI Maintain Customer Quality Control Recording Shipments Note Note Note Please enter Lot quantity and date received Zem DaeRecee Leteren Ote Cort type apy J Pam TJ ATCCS1299 Erte i Thes lot 5 contains the following ehipme
291. ification Card Qualifying Messages ID Message Confidence Level Choices Probability Comments Excellent 1 96 to 99 Very Good 1 93 to 95 Good 1 89 to 92 Acceptable 1 85 to 88 Low Discrimination 2 to3 Sum of choices 2 to 3 taxa exhibit same biopattern 100 after resolution to one choice percent probability reflects the number associated with selected choice Separate by supplemental testing Unidentified gt 3 n a Either gt 3 taxa exhibit same Organism biopattern or or 0 Very atypical biopattern Does not correspond to any taxon in the database Check Gram stain and purity Percent Probability As part of the identification process the software compares the test set of reactions to the expected set of reactions of each organism or organism group that can be identified by the product A quantitative value the percent probability is calculated and relates to how well the observed reactions compare to the typical reactions of each organism A perfect match between the test reaction pattern and the unique reaction pattern of a single organism or organism group would provide a percent probability of 99 When a perfect match is not obtained it is still possible for the reaction pattern to be sufficiently close to that of an expected reaction pattern such that a clear decision can be provided about the organism identification The range of percent probabilities in the one
292. imination identification Contraindicating test Test result that is unusual for a reported taxon 4 6 VITEK ITEK 2 Systems Product Information 532511 4EN1 NH Product Information Additional Information on Lab Report Notes Associated with Certain Taxa Table 4 3 Notes Associated with Certain Taxa Taxa Note Haemophilus influenzae Haemophilus aegyptius is a recognized species but there is controversy as to whether it should be retained as a legitimate species Haemophilus aegyptius is indistinguishable from H influenzae by either DNA DNA hybridization or by any single phenotypic test Isolates of H aegyptius exhibit distinct pathogenicity and are associated with cases of acute purulent conjunctivitis Haemophilus influenzae biogroup Aegyptius is also indistinguishable from H aegyptius and H influenzae but is considered the etiologic agent of Brazilian purpuric fever which is a systemic pediatric infection that is typically preceded by purulent conjunctivitis that resolves before the onset of the systemic infection Consequently isolates of H aegyptius H influenzae biogroup Aegyptius and other biogroups of H influenzae will all identify as H influenzae when tested with the NH card Neisseria meningitidis Highly pathogenic organism Notes Associated with Improperly Filled Card or Negative Profile biopattern VITEK 2 Systems Product Information 4 7 532511 4EN1 For the cas
293. in Isolate Results Modifying Isolate Groups and Test Cards Modifying Isolate Groups and Test Cards When making changes from the View and Maintain Isolate Results view make sure you are making changes at the appropriate level Isolate Group Level When you need to make a change to an isolate group select the isolate level in the navigation tree and make the necessary changes in the active workspace Card Level When you need to make a change at the card level select the actual card that you need to change and make the necessary changes in the active workspace For example A laboratory technologist realizes that they added an AST card to the wrong isolate group They need to make a change to the AST card and not to the entire isolate group To do so they select the individual AST card in the navigation tree to make the necessary changes to the AST card with information in the workspace area To modify all cards in an isolate group select the isolate to make the necessary changes to the group When working with isolate groups at the isolate level or test card level from the navigation tree you can view the following information at any time Laboratory Identification Number Isolate Number Organism Patient Specimen Information Review Status ID Confidence Analysis Status Analysis Messages AES Findings AST Offline Tests Test Results VITEK 2 Systems Software User Manual 8 11 510773
294. ine 1997 U S Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Institutes of Health Office of Health and Safety Biosafety in Microbiological and Biomedical Laboratories 1988 Weyant RS Moss CW Weaver RE Hollis DG Jordon JG Cook EC and Daneshvar MI Identification of Unusual Pathogenic and Gram Negative Aerobic and Facultatively Anaerobic Bacteria 2nd ed Williams amp Wilkins Philadelphia PA 1996 Vi S 4 21 ITEK 2 Systems Product Information 532511 4EN1 Bibliography NH Product Information bioM rieux Inc Use this Product Information with VITEK 2 Product No 21346 EC REP bioM rieux Inc bioM rieux SA Box 15969 au capital de 11 879 045 Durham North Carolina 27704 0969 USA 673 620 399 RCS LYON tel 1 800 682 2666 69280 Marcy l Etoile France t l 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 http www biomerieux com Copyright 2005 bioM rieux Inc All rights reserved DD WED A Come Dead EINE ema an 4 22 VITEK 2 Systems Product Information 532511 4EN1 BCL PRODUCT INFORMATION Intended Use The VITEK 2 Bacillus identification card BCL is intended for use with VITEK 2 systems for the automated identification of aerobic endospore forming organisms of the family Bacillaceae The VITEK 2 BCL identification card is a single use disposable For a list of claimed species see Organisms Identifie
295. ined parameter set all fields are read only To create a new guideline follow these steps 1 From the navigation tree select the specific guideline under the Parameter Set that you want to modify or use as a basis for a new MIC guideline and click Create New Component Figure 11 10 Create New Component Icon 11 12 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Note Note Viewing MIC Interpretation Guideline Ni Create a Custom Parameter Set and MIC Interpretation Guideline The selected parameter set NOCLSHMatural Resistance will be used as the basis for the new custom parameter set and MIC interpretation guideline It may take several minutes to create the parameter set and MIC interpretation guideline Please enter the following information Parameter Set Mame Eopy of NCCLS Natura Resistance Description NCCLS Gudeine and Natural Resistance Interpretations Figure 11 11 Create Custom Parameter Set 2 Enter a unique Name for the parameter set and a unique Name for the guideline If the current parameter set is predefined the name and description appear in the navigation zone with the new guideline 3 The system software will make a writable copy out of the current predefined guideline The new interpretation guideline name must be unique If the name entered already exists or if the name is blank an error message appears with instructions on how to comple
296. ing results a Supervisor can view the isolate s audit history The audit history captures the life cycle of an isolate from creation to archive The audit history also records all user changes To view the audit history of an isolate 1 From the View and Maintain Isolate Results view select an isolate to view the audit trail 2 Click the View Audit History icon Figure 8 18 View Audit History Icon Waudit Trail E X Isolate Audit Report Customer Number Printed by sjones System Nurnber Printed Aug 29 2003 1057 Search Criteria Lab ID 342 Isolate Number 1 QC Reference ID lt lt all gt gt User ID Recorded lt lt all gt gt Event Type lt lt all gt gt Source Database Start Date lt lt all gt gt End Date lt lt all gt gt Audit Trail Events Aug 18 2003 1041 342 1 Modified Analysis Aug 28 2003 1106 bai Reviewed Reviewed sjones Aug 28 2003 1107 mmm TT RS D Page 1 of 1 Ej85x itin Figure 8 19 View Isolate Audit 3 The isolate audit history displayed in the window is read only and appears as the information is displayed on the printed report VITEK 2 Systems Software User Manual 8 29 510773 3EN1 Exporting Results and Raw Data to Electronic Media View and Maintain Isolate Results 4 To print the report click Print 5 To export the report click Export from the window to export the audit trail information to a CD Make su
297. ing with QC Results All QC Isolates must be reviewed Based on configuration they may also need to be approved If ID analysis returns a Low Discrimination result the QC isolate is considered Qualified and you will need to review the isolate and provide additional information to allow the isolate to become Final You can configure the following options Review All Isolates Review and Approve All Isolates You can set up the review process to allow for electronic signatures and batch selection Depending on your laboratory configuration settings steps for reviewing and approving isolate results may flow differently This chapter describes the settings individually For details about configuring your system software for reviewing results validation see Chapter 9 Results Validation Configuration Viewing QC Results QC Isolates appear in the navigation tree in the View QC Results window There are several conditions when you may need to provide the system software with additional information or perform a task before the results can become final When an isolate is stopped for review or qualified the icon beside the isolate represents the state of the test or isolate The following table describes the isolate states and icons that appear beside them in the navigation tree Table 7 1 Isolate Icons and Descriptions Icon Description All QC parameters are within range Indicates that none of the QC isolates ass
298. ings 9 7 configure isolates to stop for review 9 7 configure results for review approval 9 6 enable electronic signature 9 6 enable review of MIC corrections 9 6 organism phenotype combinations 9 6 therapeutic interpretations 9 6 information about 9 6 review options 9 8 Result Validation Selections no review and approve 9 8 review all isolates 9 8 review and approve all isolates 9 8 review and approve critical isolates 9 9 review critical isolates 9 8 Result Validation Settings batch selection of isolates 9 9 electronic signature 9 9 expert findings phenotype selected for validation 9 9 MIC corrections 9 9 therapeutic interpretations 9 9 Review Batches of Isolates at One Time 7 12 Review Current QC Results 7 8 Review Results Button 7 8 Right View Bar Buttons 8 8 Sample Screen Layout 2 2 Search Audit Trail by event types 13 14 from isolate archive 13 15 Search Inactive Reports Button 5 7 Search Inactive Reports Dialog 5 7 Search Results Box 5 7 VITEK 2 Systems Software User Manual 510773 3EN1 Index 9 Index Select Organism Antibiotic Combinations to Suppress 9 3 Select Organisms for Automatic Slashline 9 3 Send Data to LIS 8 35 Send to SRF 8 9 Set Up QC Information 4 24 Settings for QC Result Review review all isolates 7 2 review and approve all isolates 7 2 Setup Tech change name of 7 6 defined 7 6 name displayed 4 8 select name from list 4 6 select new 8 15 when 21 CFR 11 is enabled 4 6 Se
299. ion ID Analysis Problems e Slashline results for an organism without an auto resolution configured Low discrimination results AST Analysis Problems Offline test required for an AST card to complete analysis Analysis must be complete and the isolate group must contain an organism that requires an offline test for antibiotic interpretation Validation Analysis Problems Detection of user configured phenotype Patient demographics If enabled problems Laboratory Identification number that is not linked to a patient Using the Right View Bar to View Specific Results When viewing an isolate result you can view additional detailed information or perform a task by clicking one of the buttons on the right view bar Figure 8 6 Right View Bar VITEK 2 Systems Software User Manual 8 9 510773 3EN1 Using the Right View Bar to View Specific Results View and Maintain Isolate Results Depending on the selected item in the navigation tree and the system software configuration parameters the following view options become available Export Isolate and Raw Instrument Data Exporting isolate and Raw instrument data allows you to copy data to a CD This helps bioM rieux Customer Support troubleshoot ID analysis or AST analysis problems View AES Graphic Clinical Use When viewing isolates if the isolate has been expertized you can click the View AES Graphic ico
300. ion 32511 4EN1 Culture Requirements Table NH Product Information Culture Requirements Table Table 4 15 Culture Requirements M I Age of VITEK 2 3 Incubation Inoculum ket ice Suspension Media Age of Culture ae Dilution H Card Conditions Density Before Loading for AST Instrument NH Campylobacter Campylobacter Campylobacter 2 70 3 30 N A lt 30 minutes TSAB 18 to 24 hours 35 Cto 37 C McFarland microaerophilic Standard conditions Fastidious Fastidious Fastidious CHOC 18 to 24 hours 35 C to 37 C 1 with 5 to 1096 CHOC PVX CO These media were used in the identification product database developments and will give optimal performance Culture Requirements Table Media Abbreviations CHOC Chocolate agar CHOC PVX Chocolate Polyvitex agar TSAB Trypticase Soy Agar with 5 sheep blood Bibliography 1 Balows A Hausler WJ Herrmann KL Isenberg HD Shadomy HJ editors Manual of Clinical Microbiology 5th ed American Society for Microbiology Washington D C 1991 2 Balows A Truper HG Dworkin M Harder W and Schleifer K H editors The Prokaryotes a Handbook on the Biology of Bacteria Exophysiologoy Isolation Identification Applications 2nd ed Volume Il Springer Verlag New York 1992 5 Difco Manual Dehydrated Culture Media and Reagents for Microbiology 10th ed 1984 4 Holt JG Krieg NR Sneath PHA Staley JT Willia
301. ions Maximum number of antibiotics and or tests that can be changed to match a phenotype The maximum number of MIC corrections is an integer from 0 to 2 The maximum number of MIC corrections by default has a value of 1 MIC Interpretation The interpretation guidelines such as CLSI CA SFM Global applied to the MIC results Therapeutic Interpretation The therapeutic interpretation guideline applied based on the recognized phenotype s Activating a Parameter Set The active parameter set appears in the navigation tree and is flagged with the active icon You can view inactive parameter sets but a parameter set will not become active until you activate it Ca Available Parameter Sets A Pre defined E CA SFM Phenotypic FE CLSI E e SSRI Resistance MIC Interpretation Therapeutic Interpretation L Global CLSI Global Natural Resistance EI Global Phenotypic Ej CA Industry Figure 11 5 AES Active Parameter Set Only one parameter set is active at a time The guidelines associated with the active parameter set are considered the active guidelines for system software analysis and interpretation The parameter set used for AES can be changed by activating a new parameter set To do so follow these steps Note To activate a parameter set you must be at the parameter set level 1 Select the parameter set that you would like to activate 2 Click Activate Current Parameter Set 11
302. isolate information during cassette setup For an example see Appendix A Blank Cassette Worksheet L CEN Cassette Worksheet Preview Hierken Customer Cassette Worksheet primed Jul 21 2000 1142 General Information Instrument Name Date Time Cassette Information Cassette ID Bench Name Setup Tech Name Card Type Bar Code Lab ID Isolate Number Organism Offline Tests and Organism Quantity Results D Page 1 of 1 28 5 x 11 in Figure 4 11 Example Blank Cassette Worksheet Editing Modifying Cassette Information After you have defined and saved the cassette you will only be able to make changes to the information from the View and Maintain Isolate Results view However if the cassette is a Virtual Cassette you will be able to make changes until the cassette is loaded into the instrument For details on viewing and maintaining isolate information see Chapter 8 View and Maintain Isolate Results 4 14 VITEK 2 Systems Software User Manual 510773 3EN1 Set Up Test Cards and Cassette Information Defining the Selected Cassette Ejecting Cards from Instrument You can eject a card from the instrument at any time while in the Manage Cassettes view To eject a card 1 Select the Cassette ID from the navigation tree The cassette will appear in the workspace 2 Select the card that you wish to eject 3 Click Eject Figure 4 12 Eject Icon 4 The system prompts you t
303. isposable test tubes Sterile swabs Appropriate agar medium See Culture Requirements Table on page 5 21 Optional accessories Saline dispensers Pre dispensed saline test tubes saline 0 45 to 0 50 pH 4 5 to 7 0 Test tube caps Vortex Procedure For product specific information see the Culture Requirements Table on page 3 21 Note Prepare the inoculum from a pure culture according to good laboratory practices In case of mixed cultures a re isolation step is required It is recommended that a purity check plate be done to ensure that a pure culture was used for testing 1 Select isolated colonies from a primary plate if culture requirements are met or Subculture organism to be tested to appropriate agar medium and incubate accordingly 2 Aseptically transfer 3 0 mL of sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 into a clear plastic polystyrene test tube 12 mm x 75 mm 3 Use a sterile swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in step 2 Prepare the homogenous organism suspension with a density equivalent to a McFarland No 1 80 to 2 20 using a calibrated VITEK 2 DENSICHEK Note Filamentous species may pick up small amounts of glucose from the isolation media This has the potential for causing false positive reactions Avoid scraping or rubbing the agar when preparing the organism suspension For strains which do not
304. ist of antibiotics or organisms and type any codes into the host code column that you need to map to your external data management system WAC Configuration AN an AM SAM lam An gt Enge Eee OR TLC IN S e 133 eae Ty ei ag Figure 12 36 BCI Translation Tab 12 30 VITEK 2 Systems Software User Manual 510773 3EN1 SYSTEM UTILITIES 3 About This Chapter This chapter describes the following system utilities Create and Maintain User Security Create and Maintain AST Card Definitions View and Maintain Instrument Status Archive Search Isolate History Audit Trail and Export Data to a CD Chapter Contents Create and Maintain User and Security Settings 13 2 Initial User Accounts 13 2 Creating User Accounts 13 3 Adding User IDs to User Groups 15 4 Creating AST Card Definitions 15 5 Deleting a Card Definition 13 6 Maintain AST Card Definitions 13 7 Archive Isolate Reports and Isolate Audit Trail 13 8 Archiving Isolates 13 8 Archive Isolates 13 9 Archiving Isolates to a CD 13 10 Too Many Isolate Reports for One CD 13 11 Viewing and Searching Archived Isolate Reports 13 11 Search Audit Trail 13 13 Searching Audit Trail by Isolates or by the Application System 13 13 Saving Audit Trail to a CD 13 16 Exporting Results and Raw Data to Electronic Media 13 16 Print Audit Trail Reports 13 17 VITEK 2 Systems Software User Manua
305. ith unusual Disabled findings are stopped for review For example an isolate with an organism identification of Shigella would be stopped for review 5 The additional result validation settings include the items listed in the following table Table 9 3 Result Validations Settings Default Options Description Settings Electronic Signature If enabled requires that a user Disabled enter the User ID and Password to review or approve an isolate Batch Selection of Isolates Enable this to allow selection Disabled of multiple isolate results for review or approval Expert Findings Phenotype Selected Select organism phenotype None for Validation combinations to stop for Selected review or approval click Review ALL to quickly select all for review Click Review None to deselect all combinations MIC Corrections Enable review of MIC Enabled corrections Therapeutic Corrections Enable the review of Enabled Therapeutic Interpretation Corrections 6 Click Save when you have made the necessary changes 7 Click Lock to lock the view and then you can move on to another view VITEK 2 Systems Software User Manual 9 9 510773 3EN1 Results Validation Configuration Configure Results Analysis and Review 9 10 VITEK 2 Systems Software User Manual 510773 3ENI PART IV CONFIGURE THE WORKSTATION AND MAINTAIN SYSTEM UTILITIES VITEK 2 technology CONFIGURE AND MA
306. ive 0 to 5 positive 2 12 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information Limitations Limitations The VITEK 2 GP card cannot be used with direct clinical samples or other sources containing mixed flora Any change or modification in the procedure may affect the results Newly described or rare species that are found occasionally may not be included in the GP database Selected species will be added as strains become available Testing of unclaimed species may result in an unidentified result or a misidentification Performance Characteristics In a recent multi site clinical study the performance of the VITEK 2 GP was evaluated using 457 clinical and stock isolates of both commonly and rarely observed species of gram positive cocci The reference identification was determined with api STAPH and api 20 STREP identification kits Overall the VITEK 2 GP correctly identified 96 5 of the isolates including 2 2 low discrimination with the correct species listed Misidentifications occurred at 3 3 and no identifications occurred at 0 2 Organisms Identified by the GP Card Abiotrophia defectiva Aerococcus urinae Aerococcus viridans Alloiococcus otitis Dermacoccus nishinomiyaensis Kytococcus sedentarius Enterococcus avium Enterococcus casseliflavus Enterococcus cecorum Enterococcus columbae Enterococcus durans Enterococcus faecalis Enterococcu
307. k 3 Make the appropriate selections and changes to customize the isolate results review and approval process Note By default Review Critical Isolates is selected Results Validation Configuration Configure Results Analysis and Review WResult Validation Configuration Pheretype FESISTANT e EXTENDED SPECTRUM Ut TA LACTAMASE JEXTENCED SPECTRUM BETA LACTAMASE ron Leven CRPHALOSPONINASE EXTENCCO SPECTRUM DETA LACTAMASE dada data quqara RESISTANT VAN A LKE Figure 9 3 Result Validation Configuration 4 Select from the following review options Table 9 2 Result Validation Selections No Review or Approve Isolates are not stopped for Disabled review and are typically sent directly to the data management system Review All Isolates All isolates are stopped for Disabled review Review Critical Isolates Only isolates with unusual Enabled findings are stopped for review For example an isolate with an organism identification of Shigella would be stopped for review Review and Approve All Isolates All isolates must be reviewed Disabled and approved 9 8 VITEK 2 Systems Software User Manual 510773 3EN1 Configure Results Analysis and Review Results Validation Configuration Table 9 2 Result Validation Selections NES Default ion Description o Options escriptio Settings Review and Approve Critical Isolates Only isolates w
308. l 13 1 510773 3EN1 Create and Maintain User and Security Settings System Utilities Create and Maintain User and Security Settings To begin using the VITEK 2 Systems software you need to set up the computer to allow users to log in to the system software The VITEK 2 Systems software uses the User ID User Name and Password created in Windows XP to authenticate users You must enable user accounts with an active password from within Windows XP to allow users log in to VITEK 2 Systems software Note It is recommended that you use the specified user groups for increased security and the user information in the Audit History To create new user groups you must log in to Windows XP as an Administrator You will need to Create User Accounts IDs Add User Accounts IDs to the User Groups Note For details please refer to the Windows XP online help Initial User Accounts There are four initial user accounts already established upon installation Each user account maintains access to certain functionality based on their group membership The following tables specify the user account and user group information provided with VITEK 2 System Table 13 1 User Group Descriptions Group Comment Administrators Windows XP group with full access to the operating system Users Windows XP group with limited access to the operating system Supervisors VITEK 2 System group Log in to VITEK 2 Systems
309. l el el e System Cautions Warnings CAUTION Do not change the Desktop Theme and Appearance Changes to these settings will affect the appearance of VITEK 2 Systems software CAUTION Ensure adequate ventilation of the workstation PC as specified by the manufacturer CAUTION It is the responsibility of the Laboratory to uniquely identify patient demographic data CAUTION The VITEK 2 Systems software is intended to provide therapeutic guidance only and should be used in conjunction with clinical indications in making an informed decision CAUTION Follow local regulations when disposing of the workstation components containing batteries PCBs or other potentially hazardous waste materials CAUTION Follow the manufacturer s instructions for proper cleaning and maintenance of the Uninterruptible Power Supply UPS provided by the manufacturer CAUTION Place the UPS near the floor in a location where it is unlikely to be bumped and or fall VITEK 2 Systems Software User Manual 1 9 510773 3EN1 Table of Symbols How to Use This Manual Table of Symbols Symbols that may appear in the instructions for use or on the instrument package inserts or packaging include C CE Marking of Conformity Consult Instructions for Use Use By ul Manufacturer Date of Manufacture Contains Sufficient for lt n gt Tests mg Keep Dry Fragile Handle with Care N Caution Consult Accompanying Documents Biolo
310. l identification test you can select the individual card to view the details for the individual wells 1 From the View and Maintain Isolate Results view select an identification card by selecting either the card itself or an isolate group containing an identification card only 2 The detailed identification information displays in the active workspace sorted by well number for each tested biochemical 8 18 VI S I ITEK 2 Systems Software User Manua 510773 3EN1 View and Maintain Isolate Results AST Card Details The following biochemical results may appear in the result column for tests TABLE 8 3 BIOCHEMICAL RESULTS Positive Negative Weak Positive Weak Negative AST Card Details View Detailed Antibiotic Results When viewing AST card results the detailed antibiotic results appear in the active workspace 1 Select an AST card or an isolate group containing one or more AST cards to view tested and deduced antibiotics VU View and Maintain Isolate Results v 101 1 Fach coi Ofna Nov 26 2003 Dy 1024 Ertero faecahe Ww 10 1 Str pneumoniae S y 104 1 C albicans BE 105 1 wt ow Discrime B 105 1 lt Low Dome D B 107 1 lt lt Sasrines gt Daring Anatysis Status 18 0 be Fret Analyste Messages rcanisa not valid for eeptibiliry testing Perfora Consistort Phenotypes Selected for Rewew CIA
311. l sum of 100 is retained through the calculation process After resolution to one choice the probability characteristic of the single choice is retained VITEK 2 only Results appear as or The indicates a reaction too close to the threshold to be considered a clear positive or negative reaction VITEK 2 Compact only Results appear as or When a clear positive or a clear negative cannot be determined the result may appear as a weak negative which indicates a reaction slightly below the threshold or a weak positive 4 which indicates a reaction slightly above the threshold Additional Information on Lab Report VITEK 2 Systems Product Information 1 7 069041 4EN1 Supplemental test External test that allows the user to resolve a slashline or Low Discrimination identification Contraindicating test Test result that is unusual for a reported taxon Additional Information on Lab Report GN Product Information Notes Associated with Certain Taxa Table 1 3 Notes Associated with Certain Taxa Note Taxa Confirm by serological tests Escherichia coli 0157 Francisella tularensis Salmonella group Salmonella ser Gallinarum Salmonella ser Paratyphi A Salmonella ser Typhi Shigella group Shigella sonnei Highly pathogenic organism Brucella melitensis Burkholderia mallei Burkholderia pseudomallei Escherichia coli 0157 Francisella tularensis Vibrio cholerae Yersinia p
312. laced on a drop of 3 hydrogen peroxide produces gas bubbles The bacteria that contain cytochrome enzyme are catalase positive Differentiation of Micrococcaceae from Streptococcaceae O 1718 21 CLINDA S Clindamycin susceptible Zone of inhibition around the clindamycin disk gt lt 20mm Used to differentiate Lactococcus lactis and Lactococcus garvieae DEXTRAN DEXTRAN ON AGAR SAC Formation of mucoid colonies from production of dextran on sucrose agar Vi S 2 19 ITEK 2 Systems Product Information 069042 5EN1 GP Supplemental Tests Abbreviation Table 2 14 Test Name GP Supplemental Tests Description GP Product Information Comments Reference ESCULIN ESCULIN hydrolysis Hydrolysis of esculin forms esculetin that produces a black pigment in the presence of iron salts 3 17 18 21 Gas prod Gas production Production of CO from degradation carbohydrate e g glucose metabolism 21 HIP HIPPURATE hydrolysis Hydrolysis of sodium hippurate releases glycine that produces a blue colored product after addition of ninhydrin 1718 21 LitmusMILK Litmus Milk Medium Acid production in Litmus Milk NaCl 6 5 GROWTH IN 6 5 NaCl Growth in 6 5 NaCl broth NO3 NITRATE REDUCTION Test for the ability to reduce nitrate to nitrite 17 18 NOVO_R OPTO_R VANCO_R NOVOBIOCIN RESIST
313. lectronic Signature is needed you are prompted to enter your User ID and Password to review or approve the results Note You can also Batch Review and Approve QC isolates For details see Batch Review and Approve on page 7 11 VITEK 2 Systems Software User Manual 7 7 510773 3EN1 Approving QC Results Supervisor Only Maintain Customer Quality Control Approving QC Results Supervisor Only A supervisor can approve QC Isolate results Multiple approvals are allowed without requiring a change to the information in the results If the system software is configured for Batch review you can approve one or more QC isolate groups at a time Note Any QC isolate with analysis complete and a status of Final is available for review and approval QC results waiting to be approved are preceded by the To be Approved icon To approve QC Results 1 Select a QC Isolate group preceded by the To be Approved icon 2 Click the Approve Results icon E Figure 7 5 Approve Results Icon 3 Depending on your results validation configuration the following may occur If Electronic Signature is required you must enter your User ID and Password to approve these results If an Electronic Signature is not needed the final results are transferred to the QC Cumulative workspace for long term storage Applying Electronic Signature An electronic signature is a computer data compilation of a symbol or series of symbols authorized by an in
314. line CBA CHBA TSAHB AST BCP YEAST TSA CHOC PVX TSAB CID2 CPS ID3 SAB SAB GLU CN and CBA 18 to 24 35 C to 37 C 0 50 to 0 63 145uLin lt 30 minutes hours McFarland 3 0 mL 1 Aerobic non CO AST GN MAC Standard saline pair TSAB GPand TSAB 18t024 35 C to 37 C 0 50 to 0 63 280pLin lt zo minutes hours Mcfarland 3 0 mL AST GP CBA 5 to 10 CO e tandard pair or Aerobic non CO gedd MN 6 6 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Culture Requirements Table Table 6 1 Culture Requirements Table Age of VITEK 2 T Age of Incubation Inoculum Dilution BEER d Media Culture Conditions Density for AST Before Car Loading Instrument SDA 18 to 72 35 C to 37 C 1 80 to 2 20 280pLin lt 30 minutes 1 hours aerobic non CO McFarland 3 0 mL YST and TSAB Standard saline AST CBA YEAST ts Pair CHBA CPS ID3 These media were used in the identification product database developments and will give optimal performance Culture Requirements Table Media Abbreviations Alb ID2 Albicans ID2 Agar BCP Bromocresol Purple Agar CBA Columbia sheep blood agar CHBA Columbia Horse Blood Agar CHOC PVX Chocolate Agar w Polyvitex CID2 Candida ID2 Agar CPS ID3 CPS ID3 Agar MAC MacConkey agar SAB Sabouraud Agar SAB GLU Sabouraud Agar w 2 glucose SDA Sabouraud Dextrose Agar SDA S
315. llow these steps 1 Select a custom Therapeutic Interpretation Guideline 2 Select the organisms antibiotics and phenotype to view using the filter 3 Select one of the Therapeutic Interpretations 4 Make a change to the custom interpretation column VITEK 2 Systems Software User Manual 11 19 510773 3EN1 Viewing Therapeutic Interpretation Guideline View and Configure AES Keowledge Bam Var siorc 10 Jan 5 2004 221 13 PM Parameter Set Matus nacive eren PETENOGENEOUS sac RESISTANT AACE PETEROCOROS CA ACD pesuwroen MCTUNOGUNEUS PANCE RESISTANT AACE PETEROGENEOUS 4AAC E Staren PETEROGENECUS CT ARCU RESISTANT apen ii HETEROGENEOUS 7 AAC R HETEROGENEOUS Cs AAC E RESGTANT AACU VITEK 2 technology Figure 11 19 Modify Custom Column 5 The therapeutic interpretations are updated based on the changes Note The custom information appears highlighted Add Therapeutic Interpretation To add a Therapeutic Interpretation to a custom therapeutic interpretation guideline 1 From a Custom Therapeutic Interpretation Guideline click the Add Sign icon Figure 11 20 Add a New Therapeutic Interpretation 2 Filter to select the Organism Antibiotic and Phenotype combination to add a new therapeutic interpretation guideline 11 20 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Viewing Therapeutic Interpretation Guideline NW A
316. log in as a supervisor To delete transaction log information follow these steps 1 2 3 4 Select the messages you want to delete Click on the Date amp Time corresponding to the message you want to delete You can select several messages at a time Select the first message press Shift and select the last message to delete or Press Ctrl and select in succession the messages you want to delete Click the Delete button The corresponding messages disappear EI Figure 12 9 Delete Button 12 8 VITEK 2 Systems Software User Manual 510773 3ENI Link Operation Note Configure and Maintain BCI The transaction entries selected for deletion are deleted regardless of status Printing Uploaded Messages To print uploaded messages 1 Select the message that you want to print 2 Click on the Print button To print one or more messages at a time 3 You can select several messages at a time by Selecting the first message pressing Shift and selecting the last message to be printed or Pressing Ctrl and selecting in succession the messages you want to print 4 Click the Print button Figure 12 10 Print Button Note After each print out the screen must be refreshed To do so you have to perform a new search 5 Click the Search button Figure 12 11 Search Button Link Operation This menu gives access to four possible interface communication links These links are
317. logy prior to selecting which identification card to inoculate The card performs as intended only when used in conjunction with VITEK 2 systems Do not use glass test tubes Use clear plastic polystyrene test tubes only Variation exists among test tubes of standard diameter Carefully place the tube into the cassette If resistance is encountered discard and try another tube that does not require pressure to insert Ensure that cards are filled properly and do not load any cards that are filled improperly Prior to inoculation inspect cards for tape tears or damage to the tape and discard any that are suspect Check the saline level in the tubes after the vacuum fill Give special consideration to sample source Interpretation of test results requires the judgment and skill of a person knowledgeable in microbial identification testing Additional testing may be required WARNING All microbial cultures are potentially infectious and should be treated with universal precautions 12 13 Storage and Handling Upon receipt store VITEK 2 BCL cards unopened in their original package liner at 2 C to 8 C Specimen Preparation For specimen preparation information see the Culture Requirements Table on page 5 23 5 2 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information Materials Materials Procedure When used with VITEK 2 instrumentation the BCL card is a compl
318. lth and Human Services Public Health Service Centers for Disease Control and Prevention National Institutes of Health Office of Health and Safety Biosafety in Microbiological and Biomedical Laboratories 1988 11 National Committee for Clinical Laboratory Standards Reference method for Broth Dilution Antifungal Susceptibility Testing of yeasts Approved Standard Second Edition M27 A2 Vol 22 No 15 August 2002 Permission to incorporate portions of M100 S15 Performance Standards for Antimicrobial Susceptibility Testing Fifteenth Informational Supplement in the bioM rieux clinical microbiology instrumentation and System has been granted by CLSI The current standard and supplements to it may be obtained from CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 USA T XQ e TE VO SO da Den d tee A aa 6 38 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Bibliography bioM rieux Inc Online Product Information 2005 Use this Online Product Information with VITEK 2 AST Products Fe REP bioM rieux Inc bioM rieux sa Box 15969 au capital de 11 879 045 Euros Durham North Carolina 27704 0969 USA 673 620 399 RCS LYON tel 1 800 682 2666 69280 Marcy l Etoile France tel 33 04 78 87 20 00 fax 33 04 78 87 20 90 http www biomerieux com Copyright 2005 bioM rieux Inc All rights reserved VITEK 2 Systems Product Information 6 39 510774 3EN1 Biblio
319. ly e g E Coli penicillinase beta lactam antibiotics Positive Reaction The condition attributed to a Well when its Percent Growth reaction meets or exceeds a predetermined threshold level A weak positive reaction is slightly above the predetermined threshold level Quality control A special VITEK 2 Systems software program that validates testing analysis and cards against a set of control organisms Raw data A set of instrument readings on a card that can be useful when troubleshooting the system React File A table of positive reaction percent probabilities for each organism and for each biochemical test Reference ID A special identification number which differentiates a quality control organism from a clinical isolate Resistance Mechanism A genetically determined property allowing a bacterial strain to be resistant to certain antibiotics within a family In AES the association of several resistance mechanisms within the same antibiotic family is considered to be another resistance mechanism Setup Technologist A staff member entrusted to setup cassettes view and maintain data in the VITEK 2 Systems software Access rights established through their identity in Windows determine the number and type of screens available to the technologist Shipment A set of Test Cards and Disposables received from bioM rieux Inc Slot Number A number that designates from which slot in the cassette the card originated from Speci
320. m History 5 Click Print to print an alarm report with the information that appears in this window A print window appears 6 Make the appropriate print selections and click OK 7 The Instrument status report prints to the workstation printer 8 Click OK View Alarm History The system stores the alarm message history for 50 days before automatically removing it from the system To view the alarm message history click the Instrument Status icon at the bottom of the screen To view the alarm message history follow these steps 1 From any workspace area click the Instrument Status icon at the bottom of each screen 2 Click on the Alarm History tab to view the alarm history 3 The following information appears Type of message Date and time the error occurred Description including Serial Number and Instrument Name Error Code Source of the error Acknowledge User ID Acknowledge Date amp Time Note This window displays the instrument and system software alarm history The alarm history is self maintaining Alarms are available for viewing and printing for 30 days after the alarm was logged by the workstation VITEK 2 Systems Software User Manual 3 7 510773 3EN1 View Alarm History Instrument And System Status Wu Alarm Messages Instrument Status CurrentAlarm Alarm History Current Instrument Status Monthly Instrument Status Alarm History Report Printed Oct 13 2003 1910 LOG Executive EC
321. men The material received in a laboratory for testing Standard Same as Interpretation set A set of category calls that has been compiled by a recognized consensus committee and applied in a particular country Susceptibility The in vitro measurement of an organism s ability to replicate when it is exposed to specific antibiotic concentrations Glossary 6 VITEK 2 Systems Software User Manual 510773 3ENI System user Tab Test Card Test type Tested antibiotic Therapeutic Interpretation Changes Therapeutic Interpretation Toolbar UPS User Interface View Glossary The user group ID for the user currently logged on to the computer The portion of a folder that contains the folder s label or function title A plastic disposable card consisting of a set number of wells that contains either biochemical substrates for identification purposes or antimicrobial concentrations for susceptibility testing of microbes Commonly referred to as Card A multiple character product name indicating the kind of test card The test type may have an optional dash followed by a four character identifier The antimicrobial agent on a susceptibility card A modification message where AES recommends changes to category interpretations based on CLSI CA SFM Natural Resistance or another committee s recommendation An interpretation of the susceptibility results after biological validation AES can propose i
322. mpini Pathumwan Bangkok 10330 tel 66 2 651 98 00 fax 66 2 651 98 01 Turkey bioM rieux Diagnostik A S Degirmen Sok Nida Plaza Kat 6 34742 Kozyata i Istanbul tel 90 216 444 00 83 fax 90 216 373 16 63 United Kingdom bioM rieux UK Ltd Grafton Way Basingstoke Hampshire RG22 6HY tel 44 1256 461881 fax 44 1256 816863 USA bioM rieux Inc 100 Rodolphe Street Durham NC 27712 tel 1 919 620 2000 fax 1 919 620 2211 Vietnam Representation Office bioM rieux Vietnam Rep Office 17 Nguyen Van Mai Ward 8 District 5 Ho Chi Minh City tel 84 88 299 599 fax 84 88 207 898 Warranty bioM rieux Inc disclaims all warranties express or implied including any implied warranties of MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE bioM rieux shall not be liable for any damages including incidental or consequential damages IN NO EVENT SHALL BIOM RIEUX S LIABILITY TO CUSTOMER UNDER ANY CLAIM EXCEED A REFUND OF THE AMOUNT PAID TO BIOM RIEUX FOR THE PRODUCT OR SERVICE WHICH IS THE SUBJECT OF THE CLAIM Liability Disclaimer bioM rieux 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 bioM rieux without notice and without implying any obligation or liability on the part of the company Intellectual Property bioM rieux VITEK api and a
323. ms ST editors Bergey s Manual of Determinative Bacteriology 9th ed Williams and Wilkins Baltimore 1994 Da 0 9 NT EM OO SC eta me Dodo A 4 20 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information 10 11 12 13 Bibliography Koneman EW Allen SD Janda WM Schreckenberger PC Winn WC editors Color Atlas and Textbook of Diagnostic Microbiology 4th ed Lippincott Philadelphia PA 1992 Koneman EW Allen SD Janda WM Schreckenberger PC Winn WC editors Color Atlas and Textbook of Diagnostic Microbiology 5th ed Lippincott Philadelphia PA 1997 Krieg NR Holt JG editors Bergey s Manual of Systematic Bacteriology 9th ed Williams and Wilkins Baltimore 1984 Manafi M Kneifel W Bascomb S Fluorogenic and chromogenic substrates used in bacterial diagnostics Microbiol 1991 Rev 55 335 348 Murray PR Baron EJ Pfaller MA Tenover FC Yolken RH editors Manual of Clinical Microbiology 7th ed American Society for Microbiology Washington D C 1999 Murray PR Baron EJ Jorgensen JH Pfaller MA and Yolken RH editors Manual of Clinical Microbiology 8th ed American Society for Microbiology Washington D C 2003 National Committee for Clinical Laboratory Standards M29 A Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guidel
324. ms software assigns a consecutive dash number to the lot number for example 1 2 etc An analysis message which indicates biochemical results for an organism closely resemble the species pattern of two or more closely related organisms Minimum inhibitory concentration measured in micrograms per milliliter ug mL Commonly referred to as MIC The organism is inherently resistant to an antibiotic in its natural state wild type without any acquired or induced resistance mechanisms The condition attributed to a Well when its Percent Growth reaction does not meet a predetermined threshold level A weak negative reaction is slightly below the predetermined threshold level Identification of a microorganism provided by the identification card A subjective value describing the amount of organism growing on an Isolation Medium Current practice includes phrase and number definitions e g growth of five colonies would be described as rare or 5 In the VITEK 2 Systems software the value is a free field attached to the individual cassette Demographic information concerns the source of a specimen in clinical system applications Disease producing agents or microorganisms Pathogenic is the adjectival from of Pathogen ITEK 2 Systems Software User Manual 510773 3EN1 Glossary 5 Glossary Phenotype The wild type pattern or the expression of one resistance mechanism of one species for one antibiotic fami
325. n 12 15 Links configuration settings 12 17 interface communication links 12 9 view Index 6 VITEK 2 Systems Software User Manual 510773 3ENI Index link history 12 12 real time interface connection 12 13 LIS antibiotic not sent to 8 19 antibiotics sent to 8 20 results not sent to 8 20 9 5 Log In procedure 2 8 Log Out procedure 2 9 Lot Number QC cumulative report sorts by 7 18 M Main View 2 3 Maintain Cassettes Set Up Tests 2 4 Maintain SRF Data View access 6 5 associate SRF organism to unassociated biopattern 6 5 create SRF organism 6 5 delete SRF organism 6 5 information about 2 5 Manage Patient Information view limited patient demographics 10 10 Manage Smart Carrier Station Cassettes 4 22 Manual find topics 1 4 find topics online 1 5 notes 1 7 organization 1 4 purpose 1 3 references to other sections 1 6 standard symbols 1 7 1 8 1 10 typographic conventions 1 5 usage conventions 1 5 Max Card Incubation 9 3 Messages acknowledge all alarm messages 5 6 analysis 8 11 delete uploaded messages 12 8 error warning on new user login 2 10 how to customize therapeutic interpretation guideline 11 19 in set up tests workspace area 4 6 instrument 5 6 instrument alarm message history 5 7 removed from active workspace 14 5 transaction log print uploaded messages 12 9 unable to process test cards 4 5 MIC Interpretation Guideline create new 11 12 customize 11 12 modify breakpoints 11 12 v
326. n AST cards that are not proven to be effective for treating infections for all organisms that may be tested For interpreting and reporting of antimicrobial results which have shown to be active against organism groups both in vitro and in clinical infections refer to the individual pharmaceutical antimicrobial labeling or the local therapy guidelines Urinary Use Only Antimicrobials Limitations Certain antimicrobial agents are limited to use in treating urinary tract infections According to CLSI the following agents should not be reported against pathogens recovered from infection sites other than the urinary tract except where noted Nalidixic Acid Nitrofurantoin Norfloxacin Trimethoprim sulfamethoxazole may also be appropriate for reporting on non urinary tract isolates The VITEK 2 AST card cannot be used with direct clinical samples or other sources containing mixed flora Any change or modification in the procedure may affect the results For organism antimicrobial specific limitations see the package insert Expected Values Expected results for susceptibility tests will vary based on location and institution The VITEK 2 systems were tested at several geographically VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Performance Characteristics diverse locations to assure that trends that occur by location were integrated into the performance characteristics of
327. n High Level sy S Figure 8 2 Isolate Results View Using the Navigation Tree to View Specific Isolate Results To view isolate results use the left view bar and navigation tree to select the order of appearance for the isolate groups in the navigation tree 1 From the View and Maintain Isolate Results view select the order of the results displayed by selecting one of the following categories available in the View By drop down list Isolate Tech Bench Clinical Only if enabled in configuration Patient Clinical Only if enabled in configuration 8 4 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Using the Navigation Tree to View Specific Isolate Results 2 You can also filter the results by status The following status filters are available in the Filter By drop down list Preliminary Default Show All Qualified To be Reviewed if enabled in configuration To be Approved if enabled in configuration 3 When viewing by isolate choose an isolate group or an individual test card from the navigation tree Based on your selection different functionality is available 4 The information for the selected item appears in the active workspace 5 Make any necessary modifications For details see Modifying Isolate Groups and Test Cards on page 8 11 Active Workspace versus Inactive Workspace The information that appears in the navigation tree is retriev
328. n Lab Report Supplemental test External test that allows the user to resolve a slashline or Low Discrimination identification Contraindicating test Test result that is unusual for a reported taxon VITEK 2 Systems Product Information 3 7 069043 4EN1 Additional Information on Lab Report YST Product Information Notes Associated with Certain Taxa Table 3 4 Notes Associated with Certain Taxa Note Taxa Possibility of Cryptococcus albidus Rhodotorula glutinis mucilaginosa Cryptococcus laurentii Possibility of Geotrichum Geotrichum klebahnii candidum Highly pathogenic organism Cryptococcus neoformans Notes Associated with an Improperly Filled Card or with a Negative Profile biopattern For the case where the instrument determines that the card has not been filled Terminated card no organism suspension detected For the case where the time between two readings is higher than 40 minutes CARD ERROR Missing data Forthe case where there is a negative profile Organism with low reactivity biopattern please check viability When a biopattern is calculated for an unknown organism that is completely negative or consists of both negative tests and tests that fall within the uncertainty zone the identification call will be Nonreactive biopattern The following species could potentially trigger this note if a test was atypical or fell within the uncertainty zone
329. n to see a graphical representation of MIC distributions phenotypes and observed MIC results For more information see Viewing AES Graphic Clinical Use on page 8 25 View Detailed AES Report Clinical Use When viewing results if the results have been expertized you can click View Detailed AES Report to see expertization details For details on AES see Viewing Detailed AES Report Clinical Use on page 8 24 View Audit History When working with isolates you can view the audit history of an isolate to see the life cycle of an isolate from creation to archive The audit history also includes all user changes For details see Viewing an Isolate Audit Trail on page 8 29 View Card Details When you select an individual card whether it is an AST card or an ID card you can click View Card Details to display the detailed card information You can also print this information by clicking the Print icon For details see ID Card Details on page 8 18 or AST Card Details on page 8 19 Send to SRF Industrial Use Depending on the criteria your laboratory uses to determine a SRF organism when the criteria is met you can send the result to SRF For details see Chapter 6 Criteria for Merging ID Results with SRF Results Note When 21 CFR 11 is enabled you can also click the View Previous Versions icon to view previous versions of the lab report 8 10 VITEK 2 Systems Software User Manual 510773 3ENI View and Mainta
330. nactivity Timer For details on customizing the general features see Chapter 10 Customizing General Configuration Supervisor Only 2 10 VITEK 2 Systems Software User Manual 510773 3ENI INSTRUMENT AND SYSTEM STATUS 3 About This Chapter This chapter describes how to view preview and print information about the instrument status and alarms that pertain to the system software Chapter Contents View and Maintain Instrument Status 3 2 Instrument Alarm Status Icons 3 3 View and Print Current Instrument Status 5 5 View Instrument Monthly Status 3 4 View and Acknowledge Detected Alarms 3 6 View Alarm History 3 7 VITEK 2 Systems Software User Manual 3 1 510773 3EN1 View and Maintain Instrument Status Instrument And System Status View and Maintain Instrument Status Note Whether there is an alarm condition or not you can click the Instrument Status icon to see the current status of the Instrument You can also find the monthly history of the status and alarms by clicking on the Instrument Status icon located at the bottom of each view If there is more than one instrument connected to the workstation the software displays a list of available instruments Select an instrument from the drop down list to view instrument specific status information The following instrument status can be checked Current Instrument Status Monthly Instrument Status View and Acknowledge Detected Alarms C
331. nd a specific Isolate report enter one or more of the following search criteria Laboratory Identification Number Isolate Number QC Reference ID If the Laboratory Identification Number or Isolate Number is entered entering a QC Reference ID is optional Date Range including Start Date and End Date 4 Toview the archived isolates on the system select Search Online Catalog and click Search 5 To view the archived Isolates from the Archived CD select Search CD and click Search Insert an archive CD Note If a CD is not already inserted a message appears asking you to insert an archive CD Note You may use an asterisk as a wild card when entering search criteria VITEK 2 Systems Software User Manual 13 11 510773 3EN1 Archive Isolates System Utilities 6 Alist of archived isolates meeting the specified search criteria is displayed Wichteg and View Archived Reports Figure 13 5 Archive and View Archived Reports 7 The list is sorted by Accession number followed by the date The most recent date is displayed at the top The following information is displayed Laboratory Accession Number or QC Reference ID Date and time isolate was tested in the instrument Selected organism identification for the isolate Unique Identifier for the CD that contains the isolate report 8 Select the isolate to view the Lab Report or Isolate Audit Trail 9 Click the Display Archived Report icon
332. nd do not load any cards that are filled improperly Prior to inoculation inspect cards for tape tears or damage to the tape and discard any that are suspect Check the saline level in the tubes after the vacuum fill Give special consideration to specimen source and patient drug or antimicrobic regimen Interpretation of test results requires the judgment and skill of a person knowledgeable in microbial identification testing Additional testing may be required See YST Supplemental Tests on page 3 18 WARNING All patient specimens and microbial cultures are potentially Y infectious and should be treated with universal precautions 8 10 Storage and Handling Upon receipt store VITEK 2 YST cards unopened in their original package liner at 2 C to 8 C Specimen Preparation For specimen preparation see Culture Requirements Table on page 3 21 Materials When used with VITEK 2 instrumentation the YST card is a complete system for routine identification testing of most clinically significant yeasts and yeast like organisms Required materials are VITEK 2 YST Card VITEK 2 DENSICHEK VITEK 2 DENSICHEK Power Adapter Lithium Battery for DENSICHEK DENSICHEK Calibrator 3 2 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Procedure VITEK 2 Cassette Sterile saline aqueous 0 45 to 0 50 NaCl pH 4 5 to 7 0 12x 75 mm clear plastic polystyrene d
333. ned all of the isolates in the cassette and entered all of the necessary information you can save the cassette To save the cassette 1 After you have entered all of the necessary information into the system software click Save Figure 4 8 Save Icon 2 If there are any inconsistencies the system software will prompt you to make corrections before saving VITEK 2 Systems Software User Manual 4 1 510773 3EN1 Defining the Selected Cassette Set Up Test Cards and Cassette Information Note If the cassette is not defined properly you will not be able to save the cassette 3 If everything is correct the cassette is saved to the system software and the tests begin processing data While saving the system software will also complete card analysis Note During a save the system software will also complete ID and AST analysis This may take a minute Printing Cassette Information After defining a cassette you can print the cassette layout 1 Select the cassette that you want to view The cassette appears in the workspace 2 Click Print to print or preview the Cassette Report 3 When you click Print two options appear You can select Cassette Report to get a report of the cassette setup information or Blank Cassette Worksheet LED Load Tm Now 26 2000 1230 M Print cassette Report Please select the report you want to print C antene Report Clark Cassatin Worksheet for Compact
334. need to be approved 2 Click the Send to LIS icon Figure 8 26 Send to LIS Icon 3 The system software creates an upload packet following the configuration parameters For details see Chapter 12 Configure and Maintain BCI Deleting Cards or Isolate Groups To delete a card or isolate from the instrument 1 Select the card or isolate that you want to delete 2 Click the Delete icon Figure 8 27 Delete Icon VITEK 2 Systems Software User Manual 8 37 510773 3EN1 Ejecting Cards View and Maintain Isolate Results 3 The following message appears Selected card will be ejected from the Instrument If processing and deleted from the workstation Figure 8 28 Delete Card Message 4 Confirm whether you want to delete the card or isolate group by selecting Yes or No 5 If you select Yes the card is deleted from the system software Note If 21 CFR 11 is enabled the card is not deleted from the system The card is flagged Ejecting Cards To eject a card from the instrument 1 Select the card that you want to eject 2 Click Eject Cards icon Figure 8 29 Eject Card Icon 8 38 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Reanalyzing Isolate Results 3 The following message appears Selected card will be ejected from the instrument and processing stopped Continue Figure 8 30 Eject Card Message 4 Confirm whether you want to eject
335. ng to a slashline mixed taxa identification This occurs when the biopattern is the same for the taxa listed 5 4 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information Results Supplemental tests may be used to separate slashline taxa The following species belong to the slashline taxa Table 5 1 Slashline mixed Taxa Identification Slashline Name Species Belonging to the Slashline Bacillus cereus Bacillus thuringiensis Bacillus cereus Bacillus thuringiensis Bacillus sphaericus Bacillus fusiformis Bacillus fusiformis Bacillus sphaericus Bacillus subtilis Bacillus amyloliquefaciens Bacillis amyloliquefaciens Bacillus subtilis Geobacillus thermoglucosidasius Geob thermodenitrificans Geobacillus thermodenitrificans Geobacillus thermoglucosidasius Certain species may belong to a pseudoslashline mixed taxa identification A pseudoslashline indicates a rare isolate or rare occurrence of the same biopattern Supplemental tests may be used to separate pseudoslashline taxa The following species belong to the pseudoslashline taxa Table 5 2 Pseudoslashline Taxa Pseudoslashline Name Species Belonging to the Pseudoslashline Brevibacillus brevis Brevibacillus agri Brevibacillus agri Brevibacillus brevis Paenibacillus glucanolyticus Bacillus circulans Bacillus circulans Paenibacillus glucanolyticus Paenibacilllus pabuli P
336. ngs WBC Configuration RSS Lae S ae SS SES RR id adii je spe or ar o xr A HA HU gud uuu igrala VITEK 2 technology Figure 12 34 BCI Configuration View Upload Tab BCI Download Tab This tab allows you to choose fields received from the LIS The following options are available Fields to Download The required fields are not available for selection The optional fields are enabled by default Update Duplicate Demographics When specific patient information has already been downloaded and additional information is available you can chose to update the patient information with the most recent information The default is Enabled 12 28 VITEK 2 Systems Software User Manual 510773 3EN1 BCI Configuration Settings Configure and Maintain BCI Date Format From the drop down list select the date format that you will receive from the data management system Default is mm dd yyyy WBC Configuration E E E F E E F E E E E F F E 2 VITEK 2 technology Figure 12 35 BCI Download Tab rna VITEK 2 Systems Software User Manual 12 29 510773 3ENI Configure and Maintain BCI BCI Configuration Settings BCI Translation Tab This tab allows you to set up how you want to map field codes for organisms and antibiotics To use this tab follow these steps 1 Select Organism or Antibiotic from the drop down list 2 Scroll down the l
337. ning yellow after the addition of zinc dust indicates the presence of Nitrogen gas Gas bubbles may also be observed 1 2 6 OX Oxidase Production of the enzyme cytochrome C oxidase RHIZOIDcol Rhizoid Colonies Observation of rhizoidal shaped colonies on agar Bacillus mycoides can be differentiated from B cereus and B thuringiensis by producing rhizoidal shaped colonies 1 2 6 SPORANGEsw Swollen Sporangia Microscopic examination of Sporangia for swelling Phase contrast microscopy is recommended 1 2 6 SPORE C Spore central Microscopic examination for spores situated in the center of the bacterial cell Phase contrast microscopy is recommended 1 2 6 SPORER Spore round Microscopic examination for round shaped spores Phase contrast microscopy is recommended 1 2 6 5 22 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information Culture Requirements Table Table 5 16 BCL Supplemental Tests Abbreviation Test Name Description Comments Reference SPORE T Terminal spore Microscopic examination 1 2 6 for spores situated towards either terminal end of the bacterial cell Phase contrast microscopy is recommended TOX CRYST Toxin crystal Microscopic examination Bacillus 1 2 6 presence for the presence of thuringiensis is parasporal crystals differentiated from insecticidal toxin crystals B cereus
338. not provide a warning if the password is about to expire Note f you select User must change password as next logon the user will not be able to access the VITEK 2 Systems software until after the password has been changed by logging in to Windows Ap 10 Click Create and click Close 11 Add the user to the appropriate User Group Adding User IDs to User Groups To add User IDs to User Groups log in to Windows XP as an Administrator Note f you are already logged on to an account without administrator s membership you will need to log off 13 4 VITEK 2 Systems Software User Manual 510773 3ENI System Utilities Creating AST Card Definitions Example User Name LabAdmin Password labadmin 1 Right click on the Computer icon located in the upper left corner of the desktop and select Manage to open the Computer Management window 2 From the Computer Management main window click System Tools gt Local Users and Groups gt Users 3 From the list of users shown on the right right click on one of the User IDs and choose Properties 4 From the User Properties window click on the Member Of tab then click on the Add icon 5 From the Select Groups window at the cursor type the name of the group to which you want the user to belong for example Laboratory Technologists Supervisors or Administrators 6 After entering the name of the group click OK to add the user 7 Click Apply and OK 8 You have s
339. nt Equipment Protected Throughout by Double Insulation or Reinforced Insulation Equivalent to Class Il of IEC 536 1 14 Vi E ITEK 2 Systems Software User Manual 510773 3ENI About This Chapter This chapter provides a system software overview and basic introduction to the navigation This chapter also provides procedures for accessing and logging in to the system software Chapter Contents System Software Navigation Introduction 2 2 Basic Navigation 2 2 Working in the Software Views 2 5 Main View 2 5 Main Navigation Areas of the System Software 2 3 Accessing the System Software 2 6 Starting the System Software 2 6 Logging In 2 8 Logging Out or Quitting the Application 2 9 Changing Users 2 10 Managing the Inactivity Timer 2 10 Customize the Inactivity Timer 2 10 VITEK 2 Systems Software User Manual 2 1 510773 3EN1 System Software Navigation Introduction Getting Started System Software Navigation Introduction Basic Navigation The easy to use system software allows for simple navigation to important information The following define the basic navigation used throughout most of the system software 1 Title Bar 2 Navigation Bar 3 Left View Bar 4 Navigation Tree 5 Action Bar 6 Right View Bar 7 Workspace Area 8 Status Bar VITEK 2 technology Figure 2 1 Sample View gt 2 2 VITEK 2 Systems Software User Man
340. nt of this manual It contains the titles of all chapters appendices and their sections and the page number of each title and section List of Figures Located at the front of this manual It contains a list of all figures in this manual and the page number of each figure 1 4 VITEK 2 Systems Software User Manual 510773 3ENI How to Use This Manual Typographic and Usage Conventions List of Tables Located at the front of this manual It contains a list of all tables in this manual and the page number of each table Chapter Contents Located at the front of each chapter It lists all sections in the chapter and their page numbers Page Headers Located at the top of each page There are two parts to a header the chapter title and the primary section title Page Footers Located at the bottom of each page There are three parts to a footer the manual s title the manual s part number and the page number Index Located at the back of this manual It contains topical entries and their page numbers Finding Topics Online The user documentation available with the workstation software is in Adobe PDF format When you click the link to open Help the Software User Manual and the Online Product information open in PDF format You can search PDF Files for the specific page number topic or term that you need The Table of Contents appears in the navigation tree to jump from one chapter to the next based on the
341. nt s Onte Received VITEK 2 technology Figure 7 9 Record Shipment Window 3 Enter the lot number by manually entering or scanning the bar code number located on the box If the shipment information already exists in the software if there is a problem with the bar code or if the ID or AST card type is not known the system software does not allow you to proceed If a previous shipment was received the information displays in the bottom of the window 4 Enter the Quantity Received 5 Select the Date Shipment was Received If you change the date received you will create a new shipment If you enter the same received lot you will update the shipment 6 If the appropriate information was entered click OK to record the new card information 7 The system software updates customer QC inventory with new shipment information VITEK 2 Systems Software User Manual 7 15 510773 3EN1 Printing QC Laboratory Reports Maintain Customer Quality Control Printing QC Laboratory Reports There are several types of QC laboratory reports that can be generated QC Laboratory Report for ID AST QC Detailed Card Report Cumulative QC Reports To print a QC report 1 From the View QC Results view click the Print icon Ni CET OC Reference We larceurv ARID Actual Organtame aen Expected Organisme C gsbrsto MYA 2950 Select result report type p Lab Report OC Denn
342. nt that alerts the user to the possibility of injury death or other serious adverse reactions associated with the use or misuse of a device gt CAUTION Caution is a statement that alerts the user to the A possibility of a problem with the device associated with its use or misuse Such problems include device malfunction device failure damage to the device or damage to other property Where applicable a caution statement may include a precaution that should be taken to avoid the hazard IMPORTANT Important relates to content presented in this manual It is used to reinforce the importance of your understanding or remembering something Note Note supplies additional information about a topic VITEK 2 Systems Software User Manual 1 7 510773 3EN1 System Cautions Warnings How to Use This Manual System Cautions Warnings The following represent cautions and warnings for the VITEK 2 Systems and software WARNING case or the UPS case Due to the risk of electrical shock do not open the workstation Improper cleaning and maintenance of the workstation PC AA could increase the risk of biological contamination WARNING Be sure the UPS has adeguate ventilation For details see A documentation provided by the manufacturer WARNING Possible hazard associated with bar code reader s laser A emission 1 8 VITEK 2 Systems Software User Manual 510773 3ENI How to Use This Manual gt elel e
343. ntenance Cassette Management Cleanup All aged cassettes are removed from the active workspace Cassettes that are loaded into an Instrument and which have no associated isolates in the active workspace are flagged as aged from the active workspace If a cassette is determined to be aged from the active workspace then the cassette is deleted from the active workspace Instrument Status Management Cleanup The system software removes aged messages from Instrument status active workspace If the difference between the message creation date and current date is more than four months then the message is deleted from the active workspace Alarm Management Cleanup The system software maintains alarms from the active workspace by removing aged alarms The system software applies the following criteria to delete alarms If the difference between the alarm creation date and the current date is more than 31 days then the alarm is deleted from the active workspace If the number of retained alarms exceeds 1000 then the oldest alarms are deleted until the maximum number retained is 1000 Deleted Isolates Cleanup If 21 CFR 11 is enabled the system software maintains deleted isolates in the active workspace until isolates are aged as configured in General Configurations The deleted isolate is flagged as inactive and removed from the active workspace When 21 CFR 11 is disabled deleted isolates do not remain in the active workspace
344. nterpretation changes and deduce results for untested antibiotics The area at the top of a software window that contains program icons Different icons in the toolbar represent certain functions such as printing viewing and deleting Uninterrruptible Power Supply The visual connection made between a software Application and the user Current Applications tend to use graphic representations for some interface options notably mouse selection and are referred to as Graphical User Interface GUI Any of a series of separate program windows Most views contain software options or settings that control a set of related tasks ITEK 2 Systems Software User Manual 510773 3EN1 Glossary 7 Glossary Well A space filled with a biochemical on a test card Well locations determine the specific Antibiotic or biochemical on a given card type Well Number The number of the well on a Test Card Workstation A central diagnostic station connected to the instrument communication port via a RS232 cable Under normal conditions the instrument will send system status test card data and operational data to the workstation It allows instrument data entry and calculates test results The workstation can also be used as a means to interface the VITEK 2 instruments with other computer systems The instrument is capable of buffering data for up to 18 hours should the computer fail Glossary 8 VITEK 2 Systems Software User Manual 510773 3
345. o confirm that you want to eject the card If you click Yes the instrument will eject the card and the processing for that card will stop VITEK 2 Systems Software User Manual 4 15 510773 3EN1 Using the Virtual Cassette Workflow Set Up Test Cards and Cassette Information Using the Virtual Cassette Workflow IMPORTANT The Virtual Cassette workflow can only be used with a VITEK 2 Compact instrument From the navigation tree click Virtual Cassette to switch your view from Actual Cassettes to Virtual Cassettes When a Virtual Cassette is loaded into the instrument the cassette becomes an Actual Cassette and will move from the Virtual Cassette navigation tree to the Actual Cassette navigation tree Creating a Virtual Cassette To enter information before loading the cassette into the instrument you can create a virtual cassette Creating a virtual cassette allows you to enter all of the necessary isolate information into the system software prior to loading the cassettes into the instrument The instrument then reads the cards If the Actual Cassette matches the information that has already been entered for the Virtual Cassette the cassette is saved as an Actual Cassette and is ready to receive further raw data from the instrument The Virtual Cassette information and isolate group definitions are stored within the system software The system software then sends the Virtual Cassette definition to all attached instruments so
346. o receive results OUT OF SERVICE The LIS is not available to receive results NO RESPONSE The LIS does not respond when BCI tries to open a session by sending lt ENQ gt BACK IN SERVICE The LIS is available again to receive results Configuration The protocol used and the physical parameter setting of the link are displayed on this screen The following parameters are available protocol port baud rate data bits parity stop bits and hardware flow control for a serial link port Note A laboratory technologist can start or stop the interface connections at any time Status of the Connection The status of each of the interface connections appears at the bottom of the Link Configuration screen This allows you to see the status of the three following operations for each interface connection S Start Stop Green Connection started Red Connection halted U Upload Green Transmission of results to an external data management computer is enabled Red Transmission of results to an external data management computer is disabled VITEK 2 Systems Software User Manual 12 5 510773 3EN1 Configure and Maintain BCI Supervision D Download Green Reception of results from mainframe is enabled Red Reception of results from mainframe is disabled Figure 12 4 BCI Connection Status Alarm Connection The following alarm states may appear Green No alarm Red Alarm Figure 12
347. ocal vendor for laboratory supplies and other accessories 1 2 VITEK 2 Systems Software User Manual 510773 3ENI How to Use This Manual Purpose of This Manual Purpose of This Manual The user documentation for the VITEK 2 Systems software consists of this software user manual and the online product information which are both available in PDF format from the system software Help You can easily print this manual from the workstation printer to use as a reference when you are away from the workstation Use the online manual to find software related tasks and product information For information pertaining to the instrument or to find out how to perform instrument related tasks refer to the VITEK 2 Compact Instrument User Manual or the VITEK 2 Instrument User Manual Note Screens and figures are intended for illustrative purposes only and are not to be construed as representations of actual test data results or components Screens and components are not shown to scale Intended Audience The VITEK 2 Systems software and this manual are intended for laboratory use by trained professional clinical and industrial users Most material in this manual applies to both sets of users If any information in this manual is intended for clinical use only or industrial use only it is marked Clinical Use or Industrial Use Manual Organization The following sections explain Manual and Chapter Organization Finding Top
348. ocess the software compares the test set of reactions to the expected set of reactions of each organism or organism group that can be identified by the product A quantitative value the percent probability is calculated and relates to how well the observed reactions compare to the typical reactions of each organism A perfect match between the test reaction pattern and the unique reaction pattern of a single organism or organism group would provide a percent probability of 99 When a perfect match is not obtained it is still possible for the reaction pattern to be sufficiently close to that of an expected reaction pattern such that a clear decision can be provided about the organism identification The range of percent probabilities in the one choice case is 85 to 99 Values closer to 99 indicate a closer match to the typical pattern for the given organism 1 6 V P ITEK 2 Systems Product Information 069041 4EN1 GN Product Information Additional Information on Lab Report Note Note When the reaction pattern is not sufficient to discriminate between two to three organisms the percent probabilities reflect this ambiguity The reported probability values indicate relatively the order in which the reaction pattern best corresponds to the listed possibilities The order does not however suggest that the pattern match to one of the possible identifications is clearly superior to another The probability characteristic of an overal
349. ociated with this level contains a deviation A QC parameter is out of range for one or more QC isolates Indicates that F one or more of the QC isolates associated with this level contains a deviation Preliminary Card is still processing analysis not yet complete VITEK 2 Systems Software User Manual 510773 3EN1 Maintain Customer Quality Control Viewing QC Results Table 7 1 Isolate Icons and Descriptions Icon Description Final Qualified Analysis is complete but the isolate needs additional IP information to become complete Final Not Oualified Complete Analysis is complete no additional OC L isolate information or review is needed To be Reviewed Isolate needs review to leave this state All isolates need K to be reviewed To be Approved Isolate result needs to be approved to leave this state Mr This icon appears if configured for approval Viewing Selected QC Results 1 From View QC Results view you can filter the isolates that appear in the navigation tree 2 Select from the following View By options QC Reference ID Card Type Date Tested 3 Select from the following Filter By options Current All Isolates Current Deviation Only Current To be Reviewed Current To be Approved Custom For details see Creating a Custom Filter to View Cumulative QC Information on page 7 4 4 Once you have selected how you woul
350. olate Lab Reports Isolate Audit Report Index Audit Index The results appear in the table on the screen If you want to conduct a different search using different search criteria change the criteria and click Search or Search CD Once you find the results you are looking for click Print to get a printed copy of the Search Audit Results or click the Save icon to save the Audit Trail to a CD If the system software is associated with the event the table displays System as the User ID VITEK 2 Systems Software User Manual 13 15 510773 3EN1 Saving Audit Trail to a CD System Utilities Saving Audit Trail to a CD To save the Isolate and Application system Audit History in the form of a report to electronic media 1 After you perform an Audit Trail Search the audit history appears 2 Click the Save Audit Trail to a CD icon EI m Figure 13 8 Save Audit Trail to a CD Icon 3 Insert a blank CD Note If a CD is not already inserted a message appears asking you to insert a blank CD 4 After you insert the CD the system software validates the CD and copies the isolate audit report to a CD Exporting Results and Raw Data to Electronic Media For support and troubleshooting ID and AST analysis you can export raw data to a removable media To export Isolate and Raw Instrument Data in the form of a report to electronic media 1 Insert a blank CD 2 From within the View and Maintain Results view cl
351. olates you want to review or hold down the Ctrl key and select the nonconsecutive isolates that you want to review 3 The selected isolates appear in a list in the active workspace 8 40 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain Isolate Results Approving Results JO CPC AST P506 JD GNB AST NDIT JD GNB AST NDIT VITEK 2 technology Figure 8 33 Batch Review 4 To review these isolates click the Review icon Note If Electronic Signature is enabled enter your Password to batch review these isolates Approving Results Note Only members of the Supervisor group can approve isolates Results will need to be approved depending on how the result validation is configured for your lab For Result Validation Configuration details see Chapter 9 Results Validation Configuration To approve results 1 From the View and Maintain Isolate Results view select an isolate from the navigation tree and click the Approve icon Note If Electronic Signature is enabled enter your Password to approve an isolate VITEK 2 Systems Software User Manual 8 41 510773 3EN1 Approving Results View and Maintain Isolate Results Figure 8 34 Approve Results Approving Batch Results To approve more than one isolate at a time 1 From the View and Maintain Isolate Results view select one or more isolates 2 To select and approve more than one isolate hold down the Shift key and select the conse
352. ollow your institution s internal policies and procedures to verify and validate the adequacy of this criteria bioM rieux is not responsible for any settings or configuration that differs from the bioM rieux configuration as bioM rieux is not able to ascertain the accuracy of such configurations It is recommend that you use the bioM rieux Advanced Expert VITEK 2 Systems Software User Manual 11 3 510773 3EN1 Parameter Set Information View and Configure AES Note A warning appears WARNING We recommend that you use the bloMerieux Advanced Expert System TM AES as configured by bloMerieux as these settings have been tested to function per the standards organizations and existing data If you choose to use different criteria we recommend that you follow your institution s internal policies and procedures to verify and validate the adequacy of this criteria We remind you that bioMerieux can not be responsible for any settings or configuration that differs from the bioMerieux configuration as bloMerieux Is not able to ascertain the accuracy of such configurations NOTE During customization isolates will not be expertized or interpreted In case of long system inactivity expertization may restart automatically Continue with customization Figure 11 3 AES Configuration Warning 4 Click Yes to acknowledge the warning This unlocks the AES Configuration view for changes Note When customizing AES Configuration val
353. ology Figure 13 7 Search Audit Trail 3 From within the Search Audit Trail view enter one or more of the following Laboratory Identification Number solate Number QC Reference ID Either Lab ID number or QC Reference ID is required Entering the QC Reference ID is optional if the Lab ID Number is entered Note You can use an asterisk as a wildcard in place of specific search criteria Enter a date range Start Date and End Date User ID You can also filter your search by the following event types Table 13 4 Search Events lt lt All gt gt lt lt all gt gt Approved Backup C O 13 14 VITEK 2 Systems Software User Manual 510773 3EN1 System Utilities Search Audit Trail Table 13 4 Search Events Note Isolate Events Application Events Archived Cassette Created Configuration Deleted End of Day Processing Ejected Inactivity Timer Exceeded Modified Instrument Event Report Logon Reviewed Logon Failure Logout Restore SRF VITEK 2 System Application Shutdown VITEK 2 System Application Startup 4 After you have entered all of your search criteria click Search to search 5 6 7 8 the system or click Search CD to search the archived CD If you are performing a search from the Isolate Archive be sure that an archive CD is inserted An archived CD contains the following information Is
354. ology Washington D C 1998 2 Brenner DJ Grimont PAD Steigerwalt AG Fanning GR Ageron E Riddle CF Classification of Citrobacteria by DNA Hybridization Designation of Citrobacter farmeri sp nov Citrobacter yougae sp nov Citrobacter braakii sp nov Citrobacter werkamnii sp nov Citrobacter sedlakii sp nov and Three Unnamed Citrobacter Genomospecies Int J Syst Bacteriol 1993 43 645 658 3 Chang YH Han J Chun J Lee KC Rhee MS Kim YB Bae KS Comamonas koreensis sp nov a non motile species from wetland in Woopo Korea Int J Syst Evol Microbiol 2002 52 377 381 4 CoenyeT Mahenthiralingam E Henry D Lipuma JJ Laevens S Gillis M Speert DP Vandamme P Burkholderia ambifaria sp nov a novel member of the Burkholderia cepacia complex including biocontrol and cystic fibrosis related isolates Int J Syst Evol Microbiol 2001 51 1481 1490 5 Coenye T Vandamme P Gowan JRW Lipuma JJ Taxonomy and Identification of the Burkholderia cepacia Complex J Clin Microbiol 2001 39 3427 3436 6 De Baere T Steyaert Wauters G De Vos P Goris J Coenye T Suyama T Verschraegen G Vaneechoutte M Classification of Ralstonia pickettii biovar 3 thomasii strains Pickett 1994 and of new isolates related to nosocomial recurrent meningitis as Ralstonia mannitolytica sp nov Int J Syst Evol Microbiol 2001 51 547 558 7 Freney J Renaud F Hansen W Bollet C Pr cis de bact riologie clinique ESKA Paris
355. ompletely define the selected cassette Managing Smart Carrier Station Cassettes SCS Setup Technologist ID The VITEK 2 Systems software will attempt to identify the full name of the original Setup Technologist based on the SCS Setup Technologist User ID received from a Smart Carrier Station If an exact match case sensitive is not found the system will display 2 If 21CFR 11 is enabled only a lab supervisor can edit the Setup Technologist associated with a Smart Carrier Station cassette after the cassette data has been transferred to the workstation If 21 CFR 11 is disabled any user can edit the field To edit the Setup Technologist ID 1 From the Set Up Tests Post Entry view select a cassette from the navigation tree The cassette you selected appears in the cassette workspace 2 Select one of the available names from the of Setup Technologist drop down field 4 22 VITEK 2 Systems Software User Manual 510773 3ENI Set Up Test Cards and Cassette Information Using the Smart Carrier Station SCS Note Note 3 After you have entered all of the necessary information into the system software click Save The Workstation logs the event for each isolate in the cassette if the name of the Setup Technologist changes If 21 CFR 11 is enabled the cassette will remain incomplete until a Setup Technologist is assigned If 21 CFR 11 Compliance Mode is enabled the name of the Laboratory Technologist logged onto the Wo
356. on 5 11 069045 2EN1 BCL Quality Control Table BCL Product Information Table 5 12 QC Organism Paenibacillus macerans ATCC 8509 LMG 21891 BXYL AGAL INO dMNE v PVATE v NaCl 6 5 LysA AlaA v MdG dMLZ AGLU v KAN AspA v TyrA ELLM NAG dTAG OLD V LeuA BNAG v MdX PLE v dTRE ESC PheA APPA v AMAN v IRHA INU TIZ v ProA CDEX MTE BGLU dGLU POLYBR v BGAL dGAL GlyA BMAN v dRIB v PyrA GLYG dMAN PHC PSCNa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 5 13 OC Organism Paenibacillus polymyxa ATCC 7070 LMG 21892 BXYL AGAL INO dMNE PVATE v NaCl 6 5 v LysA AlaA MdG dMLZ zz AGLU v KAN V AspA v TyrA ELLM NAG x dTAG OLD v LeuA BNAG v Mdx v PLE dTRE v ESC PheA v APPA v AMAN IRHA INU v TIZ ProA CDEX v MTE BGLU dGLU POLYBR BGAL dGAL GlyA BMAN v dRIB ip PyrA GLYG dMAN PHC PSCNa v 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 5 14 OC Organism Virgibacillus pantothenticus ATCC 14576 LMG 7129 BOL AGAL v INO dMNE v PVATE v NaCl 6 5 v LysA ip AlaA MdG v dMLZ v AGLU GP KAN AspA v TyrA ELLM v NAG dTAG v OLD v LeuA v BNAG MdX PLE v dTRE v ESC PheA APPA v AMAN v IRHA v INU v TIZ v ProA CDEX v MTE v
357. onic signature is not applied due to authentication failure If the user does not have authority to electronically sign a message appears describing the issue If the user signature fails repeatedly the system software logs the user out of the session Creating and Viewing Batch Results Multiple isolate results are known as batch or cumulative results Create batches of results to review and approve more than one QC isolate result at atime VITEK 2 Systems Software User Manual 7 9 510773 3EN1 Creating and Viewing Batch Results Maintain Customer Quality Control To create batches of isolate results 1 Select the results that you want to view by clicking on the result and holding down the Shift key to select multiple results in a row or hold down the Ctrl key to individually click different isolate group results not listed in a particular order 2 As you make your selections the isolate groups appear in the active Workspace W view QC Results C gobrats MY A 2050 C glabrata MY A 2950 K glabrata MY A 2950 glabrata MY A 2050 Sb eqd 2008 43079 Lech cot 23922 Treo mucod 204094 VITEK 2 technology Figure 7 7 Isolate Groups View 3 The following information displays QC Reference ID Organism Tested Card Type Lot Number Date Tested 4 Thelist of selected isolates displays in the active workspace If the status of all of the selected results is To Be Reviewed you can perform a batch rev
358. or all confirmed ESBL producing strains the test interpretation should be reported as resistant to all penicillins cephalosporins and aztreonam The VITEK 2 ESBL Test is a confirmatory test for those ESBLs that are inhibited by clavulanic acid The VITEK 2 ESBL Test utilizes cefotaxime ceftazidime and cefepime with and without clavulanic acid in determination of a positive or negative result Methicillin Resistant Staphylococci MRS Resistance to oxacillin is used to detect the presence of MRS Most MRS are usually also resistant to multiple antibiotics including other beta lactams aminoglycosides macrolides clindamycin and tetracycline Oxacillin OX1 This test provides an MIC determination and category interpretation for oxacillin Interpretative results for MRS will be reported as resistant to all cephems and other beta lactams when the instrument is operating in the CLSI mode or the User Defined based on CLSI mode Results from this test correlate to results that would be obtained from standard dilution testing of oxacillin This test reflects the CLSI breakpoints for coagulase negative staphylococci and S aureus Oxacillin MIC OX This test provides an MIC determination and category interpretation for oxacillin Results from this test correlate to results that would be obtained from standard dilution testing of oxacillin The default breakpoints used are for Staphylococcus species in CA SFM mode Oxacillin Screen O
359. orage Conditions 5 8 BCL Ouality Control Table 5 9 Limitations EE 5 13 Performance Characteristics 5 13 Organisms Identified by the BCL Card 5 14 BCL Well Contents 5 16 BCL Supplemental Tests 5 18 Culture Requirements Table 5 23 Culture Requirements Table Media abbreviations 5 25 Bibliography 5 24 SUSCEPTIBILITY PRODUCT INFORMATION 6 1 Intended Use emenyn Era le Ends obe a n EE E 6 1 Summary and Explanation of the Test 6 1 Principle of the Procedure 6 3 Reagents cere Rad Re ie deier da dre 6 3 iv VITEK 2 Systems Product Information 532501 3ENI Table of Contents AST Card Contents 6 3 Pr cautions iive ia ae ae rua qu e EA n gie EO Rae Pu us 6 4 Storage and Handling 6 5 Instrument eeir aa a rene date dires e Door ere rate EN 6 5 Specimen Preparation 6 5 Culture Reguirements Table 6 6 Culture Reguirements Table Media Abbreviations 6 7 Procedure ent dE Rabe lie ARR Re 6 8 Materials iili l4 ola ote bbs la Veil die de e du 6
360. ordetella avium Bordetella bronchiseptica Brevundimonas diminuta Brevundimonas diminuta vesicularis Brevundimonas vesicularis Burkholderia cepacia Cedecea davisae Cedecea lapagei Cedecea neteri Chryseobacterium gleum Chryseobacterium indologenes Chryseobacterium meningosepticum Citrobacter amalonaticus Citrobacter braakii Citrobacter farmeri Citrobacter freundii Citrobacter koseri Citrobacter youngae Comamonas testosteroni Delftia acidovorans Edwardsiella hoshinae Edwardsiella tarda Enterobacter aerogenes Enterobacter amnigenus Enterobacter amnigenus 1 Enterobacter amnigenus 2 Enterobacter asburiae Enterobacter cancerogenus Enterobacter cloacae Enterobacter gergoviae Enterobacter intermedius Enterobacter sakazakii 6 32 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information List of Claims Escherichia coli Escherichia coli ATCC 25922 Escherichia coli ATCC 35218 Escherichia fergusonii Escherichia hermannii Escherichia vulneris Ewingella americana Hafnia alvei Klebsiella oxytoca Klebsiella pneumoniae Klebsiella pneumoniae ssp ozaenae Klebsiella pneumoniae ssp pneumoniae Klebsiella pneumoniae ssp pneumoniae ATCC 700603 Klebsiella pneumoniae ssp rhinoscleromatis Klebsiella spp Kluyvera ascorbata Kluyvera cryocrescens Leclercia adecarboxylata Mannheimia haemolytica Moraxella group Moraxella lacunata Moraxella nonliquefaciens Moraxella osloensis Morganella mor
361. pact Core pt ot our Ba iro our AES Config oo AES Expert heo AES Graphe KZ Server Aren bi oro VITEK 2 compact Common pt 0 osa AST ot 01 0447 05 Uis t 0 0447 Reporting ipt ot one Analysis vtertace pro Oa Common itertace mm 0447 KH DAS Archren ipt ot oasa 10 pease R2122RC2 LL Roog 828 EELE VITEK 2 technology Figure 10 11 Version View VITEK 2 Systems Software User Manual 10 11 510773 3ENI Viewing Versions of Installed Components Configure and Maintain Workstation 10 12 VITEK 2 Systems Software User Manual 510773 3ENI VIEW AND CONFIGURE AES About This Chapter This chapter describes viewing and configuring the Advanced Expert System AES Chapter Contents Accessing AES Configuration 11 2 Parameter Set Information 11 4 AES Configuration View 11 6 AES Parameter Set Definition 11 6 Values 11 6 Deductions 11 7 Settings 11 8 Activating a Parameter Set 11 8 Creating Custom Parameter Sets 11 9 Creating a Custom Parameter Set 11 10 Deleting Custom Parameter Sets 11 11 Viewing MIC Interpretation Guideline 11 11 Customizing MIC Interpretation Guideline 11 12 Modifying Breakpoints for a Custom Interpretation Guideline 11 13 Sorting Information 11 15 Viewing Therapeutic Interpretation Guideline 11 16 Sorting Information 11 19 Creating a Custom Therapeutic Interpretation Guideline 11 19 Modifying Custom Therapeutic Interpretations 11 19
362. perations Submenu History Viewing Real time Interface Connection To allow the user to view communication packets in real time to troubleshoot an interface connection 1 Select a link to view the connection packets 2 The current connection workspace displays and the following information appears Protocol characters for example lt ENQ gt lt ACK gt etc and the related packet of information including the field code for example pn etc and delimiter for example etc VITEK 2 Systems Software User Manual 12 13 510773 3EN1 Configure and Maintain BCI Note Note Note Note Link Configuration ZB Link Operations COM Manager File Stat Stop T T d ab BIS 008 Supervision 4 Transaction Log z 3 Link Operations History Blue Upload Green Download v LI51 9 TheraTrac e Unused Unused 9 Link Configuration e LISI 9 Thera rac e Unused e Unused Hi Tools lt ENQ gt lt ACK gt lt STX gt lt RS gt 1itr s1 idBHX pi350002 pda p dult si s06 s106 06 2003 5222 06 5310 07 2003 5414 3 lt RS gt 9 ci3599906 c01 ctbcilnk enBCI Download Exam c3P c4Preliminary zz lt GS gt 5 lt ACK gt lt ETX gt lt E0T gt lt ENQ gt lt ACK gt lt STX RS mtrsl idBMX pi206251 pb03 20 1945 psF pli2MIC p2Main 6 MICU pda p6Adult w1022593 lt RS gt 3050 si 5045 ssLEUK sSLeukens Trap Sputum sli2Icc s7Main Tower 4 ICU L3 s5110 11 RS 2003 3223 38 s310 12 2003 13407 02
363. pi 20 E are registered trademarks of bioM rieux Inc DENSICHECK is a trademark of bioM rieux Inc ATCC is a registered trademark of American Type Culture Collection 2005 bioM rieux 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 bioM rieux Inc STANDARD SYMBOLS Table Of Symbols Symbols that may appear in the instructions for use or on the instrument package inserts or packaging include C CE Marking of Conformity Consult Instructions for Use Use By iid Manufacturer Date of Manufacture Contains Sufficient for lt n gt Tests EIS Keep Dry Fragile Handle with Care A Caution Consult Accompanying Documents VITEK 2 Systems Product Information Symbols 532501 3EN1 Standard Symbols FE PPS IVD LOT H a Biological Risks 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 Symbols VITEK 2 Systems Product Information 532501 3ENI Standard Symbols GO OF 7 Serial Number Do Not Reuse Fuse Recycl
364. picalis Candida utilis Candida zeylanoides Cryptococcus albidus Cryptococcus laurentii Cryptococcus neoformans Cryptococcus terreus Cryptococcus uniguttulatus Geotrichum capitatum Geotrichum klebahnii Kloeckera spp Kodamaea ohmeri Malassezia furfur Malassezia pachydermatis e Pichia farinosa Prototheca wickerhamii Prototheca zopfii Rhodotorula glutinis Rhodotorula mucilaginosa Rhodotorula minuta Saccharomyces cerevisiae Sporobolomyces salmonicolor Stephanoascus ciferrii Trichosporon asahii Trichosporon inkin Trichosporon mucoides Zygosaccharomyces bailii VITEK 2 Systems Product Information 3 15 069043 4EN1 YST Well Contents YST Well Contents YST Product Information Table 3 13 YST Well Contents Well Test Mnemonic Amount Well 3 L Lysine ARYLAMIDASE LysA 0 0228 mg 4 L MALATE assimilation IMLTa 0 15 mg 5 Leucine ARYLAMIDASE LeuA 0 0234 mg 7 ARGININE GP ARG 0 15 mg 10 ERYTHRITOL assimilation ERYa 0 5 mg 12 GLYCEROL assimilation GLYLa 0 16 uL 13 Tyrosine ARYLAMIDASE TyrA 0 0276 mg 14 BETA N ACETYL GLUCOSAMINIDASE BNAG 0 0408 mg 15 ARBUTINE assimilation ARBa 0 3 mg 18 AMYGDALINE assimilation AMYa 0 3 mg 19 D GALACTOSE assimilation dGALa 0 3 mg 20 GENTIOBIOSE assimilation GENa 0 3 mg 21 D GLUCOSE assimilation dGLUa 0 5 mg 23 LACTOSE
365. plete this isolate link the isolate to patient and specimen information You can link one or more isolates to a specimen 4 Ifthe Lab ID matches the Isolate Lab ID the software automatically establishes this link Be sure to enter the correct Lab ID If the Lab ID is incorrect the isolate will result as a qualified isolate and will not be automatically linked to the appropriate specimen Creating a Specimen Before an Isolate Exists Note VITEK 2 Systems Software User Manual 5 5 510773 3EN1 1 From the View and Maintain Patient Information window manually type the specimen information or download the information from the LIS external data management system 2 When the cassette with the matching isolate Lab ID is input into the instrument and system software the system software uses the Lab ID to automatically link the isolate and specimen information Be sure to enter the correct Lab ID If the specimen created uses the wrong Lab ID then the specimen does not automatically link to the appropriate isolate Data Management Download Manage Patient Information Clinical Use Data Management Download When patient information is downloaded from a data management system the isolate and patient information are linked by the Lab ID If there is no match for the isolate Lab ID and the specimen Lab ID the Isolate becomes qualified in the View and Maintain Isolate Results window For details on connecting to a data manag
366. ptions in this section include the following settings System Mode Inactivity Timer Move Isolate to Inactive Maximum Logon Attempts Enable 21 CFR 11 Mode 106 VITEK 2 Systems Software User Manual 510773 3EN1 Configure and Maintain Workstation System Mode and Options System Mode P a Vractsoty Tene min fro s Notre Changing mode may impact SAF AES H CFR 11 and demographic contguration settings Move Isciate to inactive days 3 F Maiza Logon Attempt 3 Print Figure 10 8 System Mode Setting the System Mode The system mode can be set to either Clinical or Industry mode Customizing the Inactivity Timer If the system software remains inactive for a specific period of time the screen saver appears and the user who was logged into the system software is logged out If you are a supervisor you can set the inactivity timer The default setting is five minutes The values on the inactivity timer range from one to 60 minutes To customize the inactivity timer 1 From the Main view select Configuration View gt General Configuration 2 If you are a Supervisor you can unlock this view to make changes 3 To modify the timer select the time from the Inactivity Timer min drop down list 4 Click Save after changes are made to the settings 5 Click the Lock icon to lock this view and move on to other views within the system software Moving Isolates to Inactive
367. purpose 9 3 select antibiotics to deduce 9 3 antibiotics to suppress 9 5 organism antibiotic combinations to suppress 9 3 set AST card ejection time 9 4 AST Card analysis problems 9 6 create new card definition 13 5 link one or more to ID card 4 10 maintain card definitions 13 7 report selected antibiotics 8 20 view card details 7 7 AST Card Details Report 8 34 AST Card Ejection Time Set hour of call 9 4 max card incubation 9 4 AST Configuration select antibiotics to deduce 9 4 antibiotics to suppress 9 5 Audit Events aged audit events removed from active and inactive workspace 14 6 Audit Trail filter search by event types 13 14 search function 13 13 Audit Trail Report 13 17 Automatic Slashline select organisms for 9 3 Backup isolate data initiated automatically by the system software 14 2 initiated by lab tech 14 3 Bar Code from package insert 13 6 missing card bar code 4 11 number of antibiotics contained on the card 13 7 order on insert 13 7 read by instrument 4 7 4 19 record shipment of new cards 7 14 scanned or entered manually 13 7 Batch Approve of selected isolates 7 12 Batch Results create view 7 10 Batch Review of selected isolates 7 11 system software configured for 7 9 BCI configuration and LIS 12 2 character set 12 26 download tab 12 28 print 12 15 settings 12 25 translation tab 12 30 upload tab 12 27 connection status link configuration 12 2 link operation 12 2 tools 12 2
368. que Occidentale 08 BP 2634 Abidjan 08 tel 225 22 40 93 93 22 40 41 40 fax 225 22 40 93 94 Japan bioM rieux Japon Ltd Seizan Bldg 12 28 Kita Aoyama 2 chome Minato ku Tokyo 107 0061 tel 81 3 5411 86 91 fax 81 3 5411 86 90 Korea bioM rieux Korea Co Ltd 7th Floor YooSung Building 830 67 Yoksam dong Kangnam ku S oul tel 82 2 547 6262 fax 82 2 547 6263 Mexico bioM rieux M xico SA de CV Chihuahua 88 col Progreso M xico 01080 D F tel 52 55 5481 9550 fax 52 55 5616 2245 Netherlands The bioM rieux Benelux BV Boseind 15 P O Box 23 5280 AA Boxtel tel 31 411 65 48 88 fax 31 411 65 48 73 New Zealand bioM rieux New Zealand Ltd 22 10 Airbourne Road North Harbour Auckland tel 64 9 415 0601 fax 64 9 415 0603 Norway bioM rieux Norge AS kernveien 145 N 0513 Oslo tel 47 23 37 55 50 fax 47 23 37 55 51 Philippines The Representation Office bioM rieux Philippines 11th Floor Pearlbank Centre 146 Valero Street Salcedo Village 1227 Makati City tel 632 817 7741 fax 632 812 0896 Poland bioM rieux Polska Sp Z o o ul Zeromskiego 17 01 882 Warszawa tel 48 22 569 85 00 fax 48 22 569 85 54 Portugal bioM rieux Portugal Lda Rua Alto do Montijo Lotes 1 e 2 Portela de Carnaxide 2794 070 Carnaxide tel 351 21 424 59 80 fax 351 21 418 32 67 Russia 0 0 0 bioM rieux Petrovsko Razoumovskii proyezd 29
369. r P Stackebrandt Priest F G 1996 Bacillus sporothermodurans a New Species Producing Highly Heat Resistant Endospores nt J Syst Bacteriol 46 759 Priest F G Goodfellow M Shute L A amp Berkeley R C W 1987 Bacillus amyloliquefaciens sp nov nom rev Int J Syst Bacteriol 37 69 Shida O Takagi H Kadowaki K Komagata K 1996 Proposal for two new genera Brevibacillus gen nov and Aneurinibacillus gen nov Int J Syst Bacteriol 46 939 5 24 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information Bibliography 12 National Committee for Clinical Laboratory Standards M29 A Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline 1997 13 U S Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Institutes of Health Office of Health and Safety Biosafety in Microbiological and Biomedical Laboratories 1988 bioM rieux Inc Online Product Information 2005 Use this Online Product Information with VITEK 2 Product No 21345 bioM rieux Inc Box 15969 Durham North Carolina 27704 0969 USA tel 1 800 682 2666 Copyright 2005 bioM rieux Inc All rights reserved VITEK 2 Systems Product Information 5 25 069045 2EN1 Bibliography BCL Product Information 5 26 VITEK 2
370. r Yen Sheng Centre 64 Hoi Yuen Road Kwun Tong Kowloon Hong Kong tel 852 2356 7033 fax 852 2330 2085 Colombia bioM rieux Colombia Ltda Avenida 15 No 100 43 Piso 2 Bogot D C tel 57 1 520 0080 fax 57 1 520 0088 1 520 0831 Denmark bioM rieux Danmark Aps Smedeholm 13C 2730 Herlev tel 45 70 10 84 00 fax 45 70 10 84 01 Finland bioM rieux Suomi Oy Rajatorpantie 41 C 01640 Vantaa tel 358 9 8545 6000 fax 358 9 8545 6045 France bioM rieux SA 69280 Marcy l Etoile tel 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 http www biomerieux com Germany bioM rieux Deutschland GmbH Weberstrasse 8 D 72622 Nirtingen tel 49 7022 30070 fax 49 7022 36110 Greece bioM rieux Hellas S A Papanikoli 70 15232 Halandri Athens tel 30 210 81 72 400 fax 30 210 68 00 880 Hungary Representation Office bioM rieux B V Reitter Ferenc u 39 49 1135 Budapest tel 36 1 412 3880 fax 36 1 412 3890 India bioM rieux India Pvt Ltd D 45 Defense Colony New Delhi 110 024 tel 91 112 464 88 40 fax 91 11 2 464 88 30 Indonesia Representation Office bioM rieux Indonesia Enseval Building Kawasan Industri Pulo Gadung JI Pulo Lentut No 10 Jakarta Timur 13920 tel 62 21 461 51 11 fax 62 21 460 41 07 Italy bioM rieux Italia S p A Via Fiume Bianco 56 00144 Roma tel 39 06 52308 1 fax 39 06 52308 240 Ivory Coast bioM rieux Afri
371. r Amount of time BCI waits before Oto 99 2 starting another session It sends an lt ENQ gt when it was master of the last session Inter Record Delay between transmission of 2 0 to 99 0 recordings by BCI Inter Message Delay between transmission of 2 0 to 99 2 messages lt STX gt lt ETX gt by BCI VITEK 2 Systems Software User Manual 12 17 510773 3EN1 Configure and Maintain BCI Link Configuration Table 12 1 Configuration Parameters Parameters Description Possible Values Default Retries lt ENQ gt Limit Number of times BCI tries to 0 to 99 20 open a session When this limit is reached BCI records an error message and places the data ina waiting list If the LIS responds BCI empties the waiting list and records a new message saying that the LIS responded lt ENQ gt Interval Amount of time BCI waits before Oto 99 5 the next transmission of an lt ENO gt following a no response or reception of a lt NACK gt Checksum Limit BCI will retransmit the entire 0 to 99 3 packet if it receives a lt NACK gt for the transmitted checksum or if the checksum Timeout expires This limit is the maximum number of packet retransmissions by BCI to try to obtain acquittal of the checksum When the limit is reached BCI records an error message and destroys the packet Checksum Interval Amount of time BCI waits before Oto 99 5 retransmitting the packet following recep
372. r more cards with the same Laboratory Identification Number and Isolate Number The isolate number is a number assigned by the lab tech to identify an organism on a culture plate An isolate number differentiates isolates taken from the same culture The isolate number values range from 1 to 99 After the test cards have been scanned set up the tests by defining isolate information An isolate group typically consists of an ID card linked to one or more AST cards of the same type To define isolate groups and link test cards 1 From the Set Up Tests Post Entry view select the cassette that you want to define from the navigation tree 2 To link an ID card and one or more AST cards select one identification card and one or more susceptibility cards of the same card class To select multiple cards click and drag the cursor across the card rows that you want to link to create an isolate group 3 Click Define Isolate Figure 4 6 Define Isolate Icon VITEK 2 Systems Software User Manual 510773 3ENI Set Up Test Cards and Cassette Information Defining the Selected Cassette 4 Awindow appears allowing you to define the isolate group Wefine kolale W Esch co AST Offline TesteRnsults Organism Quantity ary 4 VITEK 2 technology Figure 4 7 Define Isolate Window Note You cannot enter Isolate information for card slots without bar codes Saving Cassette Information After you have defi
373. rac Direction Both X e Unused Unused Date amp Time Link Direction Status Data Link Configuration 10 09 2003 07 38 53 LIST Download Sent mtrslid MXIpiG6231 1 07IpnBlackstone Gar e usi 10 09 2003 07 51 25 LIS1 Download Sent imtrslidBMIpi602507IpnD oe Johnipb05 2 Text Text2 TheraTrac 10 09 2003 07 51 29 LIS1 Download Sent mtrsllidB Mx pi602507 pnD oe Johnlpb05 2 Unused 10 09 2003 07 52 19 LIS1 Download Sent mtrsllidB MxIpi602507IpnD oe Johnlpb05 2 Unised 10 09 2003 08 38 25 LIS1 Download Sent mtrsllidB Mx pi602507 pnD oe Johnlpb05 2 dp Tools 10 03 2003 08 38 28 LIS1 Download Sent mirsllidBMX pil425730lpnSmith Janelpb10 10 03 2003 08 38 31 LIS1 Download Sent mtrsllidB Mx pi855853ipnJones Marylpb08 10 09 2003 08 38 35 LIS1 Download Sent mirsllidBMX piD 703356097 pnAdams John 10 09 2003 08 38 39 LIS1 Download Sent mirsllidBMX pi205251IpnJohnson John Jip 10 09 2003 08 38 42 LIS1 Download Sent mtrsllidB M piG 6231 1 07lpnD oe Janelpb03 10 09 2003 08 38 45 LIS1 Download Sent mtrsllidB Mx pi496372IpnPublic John Q Ip 10 09 2003 08 54 54 TheraTrac Upload Sent mirslliV21is1 2345B itlDIpi amp 2507 pv0225 10 03 2003 08 59 55 LIS1 Upload Sent mtrsllil 2lis1 23455 itlDIpiB02507 pv0225 10 09 2003 03 01 11 Download Sent mtrslidBMXIpil 23456lpnlones Man 24 10 09 2003 03 02 40 Download Sent mtrslidBMXIpi3500021pdalp amp
374. rains to estimate the typical reactions of the claimed species to a set of discriminating biochemicals If a unique identification pattern is not recognized a list of possible organisms is given or the strain is determined to be outside the scope of the database The printed lab report contains suggestions for any supplemental tests necessary to complete the identification If the tests are not sufficient to complete the identification then standard microbiology references and literature should be consulted 1 4 VITEK 2 Systems Product Information 069041 4EN1 GN Product Information Results Certain species may belong to a slashline mixed taxa identification This occurs when the biopattern is the same for the taxa listed Supplemental tests may be used to separate slashline taxa The following species belong to GN slashline taxa Table 1 1 GN Slashline Taxa Slashline Name Species Belonging to the Slashline Aeromonas hydrophila caviae Aeromonas caviae Aeromonas hydrophila Brevundimonas diminuta vesicularis Brevundimonas diminuta Brevundimonas vesicularis Burkholderia cepacia group Burkholderia cepacia Burkholderia multivorans Burkholderia stabilis Burkholderia vietnamiensis Moraxella group Moraxella lacunata Moraxella nonliquefaciens Moraxella osloensis Proteus vulgaris group Proteus penneri Proteus penneri Proteus vulgaris group Salmonella group Serratia liquefaci
375. rameter set Knowledge Base Version Displays the Knowledge Base version currently defined for analysis Parameter Set Status Displays the status of the selected parameter set The parameter set may be active or inactive If active this parameter set will be used for AES validation and interpretation Values Enable Biologic Validation If enabled the process of testing whether observed susceptibility results are consistent with the organism identification 11 6 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Deductions AES Parameter Set Definition and if not proposing the best biological change that makes the susceptibility results consistent with the organism identification Enable Forcing Rules If enabled the system software applies specific therapeutic changes as defined in the active MIC Guideline For details see Appendix B Forcing Rules Enable Therapeutic Interpretation Changes The modification of the interpretation result for an antibiotic based on proposed phenotypes AES has the ability to deduce the interpreted result for an antibiotic which has not been tested on a VITEK 2 instrument but for which the user would like to obtain results Deduced antibiotics will only report an interpretive category result and will be noted with a The user must configure each card type to obtain deduced antibiotic results For details see Chapter 9 Configure Results Analysis and Re
376. rapeutic Interpretation guidelines If you change the MIC or Therapeutic Interpretation Guideline for a custom parameter set the custom guidelines are deleted if no other parameter set references it Viewing MIC Interpretation Guideline From within the AES Configuration view you can select the parameter set in the navigation tree When the parameter set is fully expanded you can select the MIC Interpretation Guideline to view in the active workspace When selecting the MIC guidelines for a particular parameter set the name knowledge base version parameter set status and breakpoint information is displayed CAUTION When you view an Interpretation Guideline on an inactive parameter set the status indicates Inactive although the guideline displayed may in fact be active if it is linked to the active parameter set VITEK 2 Systems Software User Manual 11 11 510773 3EN1 Viewing MIC Interpretation Guideline View and Configure AES Knowledge Base Ver stan 10 Sep 29 2003 307 58 PM CA D Di GibsieNcCLS Kee Mame CCS M100 512 Jan 2002 Parameter Set Status Acte A ML Sestri Resistance DEE Bivakpouits Deet interretned Se VITEK 2 technology Figure 11 9 MIC Interpretation Guidelines Customizing MIC Interpretation Guideline An MIC Interpretation Guideline is part of a parameter set however you can only modify the breakpoints of the MIC Interpretation Guideline Note On a predef
377. ratia odorifera Serratia plymuthica Serratia proteamaculans Serratia rubidaea Shewanella putrefaciens Shewanella putrefaciens group Shigella boydii Shigella dysenteriae Shigella flexneri 6 34 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information List of Claims Shigella group Shigella sonnei Shigella spp Sphingobacterium multivorum Sphingobacterium spiritivorum Sphingomonas paucimobilis Stenotrophomonas maltophilia Vibrio alginolyticus Vibrio fluvialis Vibrio harveyi Vibrio metschnikovii Vibrio mimicus Vibrio parahaemolyticus Vibrio vulnificus Yersinia aldovae Yersinia enterocolitica Yersinia enterocolitica group Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii Yersinia pseudotuberculosis Yersinia ruckeri Gram Positive Organisms Claimed for AST GP keyid Coagulase negative Staphylococcus Coagulase positive Staphylococcus Enterococcus avium Enterococcus casseliflavus Enterococcus durans Enterococcus faecalis Enterococcus faecalis ATCC 29212 Enterococcus faecalis ATCC 51299 Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Enterococcus malodoratus Enterococcus mundtii Enterococcus spp Escherichia coli ATCC 35218 Staphylococcus aureus Staphylococcus aureus ATCC 29213 Staphylococcus aureus ATCC BAA 1026 VI S 6 35 ITEK 2 Systems Product Information 510774 3EN1 List of Claims Susceptibility Product Information Staph
378. ration Settings on page 12 25 AES Configuration See View and Configure AES on page 11 1 AST Configuration See Configuring AST Analysis on page 9 3 ID Configuration See Configuring ID Analysis on page 9 2 To access configuration views follow these steps 1 From the Main view click the Configuration icon k Figure 10 1 Configuration Icon 2 Select an option from the Configuration Option drop down menu 10 2 VITEK 2 Systems Software User Manual 510773 3ENI Configure and Maintain Workstation Unlock Lock Configuration View for Changes 4virek 2 technology Figure 10 2 Configuratlon Drop Down Menu 3 The Configuration view that you select displays Unlock Lock Configuration View for Changes Note You must be a supervisor to modify configuration settings To make changes to the configuration parameters from within any of the configuration views you will need to do the following steps 1 Unlock the view by clicking on the Unlock Lock icon Figure 10 3 Unlock Configuration view 2 Make the necessary changes to the configuration settings 3 Save the changes by clicking Save Note Be sure to save your changes Changes must be saved to lock the view and move on to the next view VITEK 2 Systems Software User Manual 10 3 510773 3ENI Save or Cancel Configuration Changes Configure and Maintain Workstation 4 Lock the view and move on to the next view Save or Cancel Configur
379. rature range and optic status Date and time readings taken Temperature Optic Status 6 You can print an instrument report which includes the information that appears in this window by clicking on the Print button View and Acknowledge Detected Alarms Instrument And System Status 7 A print window appears Make the appropriate print selections and click OK 8 The Instrument status report prints to the workstation printer View and Acknowledge Detected Alarms To view all unacknowledged alarms and acknowledge them follow these steps 1 You can check the instrument status from any Workspace View 2 When an alarm is detected click the Instrument Status icon to check the current alarm status Instrument messages are acknowledged at the instrument The system software only manages system software alarms 3 The Alarm workspace appears and the audible alarm stops sounding 4 To acknowledge the alarm click the check box Acknowledge All Messages A Alarm Messages Instrument Status Alarm History Current Instrument Status Monthly Instrument Status Current Alarm Report Printed Jun 18 2004 13 51 COT Have not received any communication from the Jun 18 2004 13 50 instrument Serial cor DPagetoft 85x110in IV Acknowledge All Messages Figure 3 7 Current Alarms 3 6 VITEK 2 Systems Software User Manual 510773 3EN1 Instrument And System Status View Alar
380. rce ERYTHRIT a ERYTHRITOL Ability to use erythritol as 2 3 5 Assimilation the sole carbon source dGALACT a D GALACTOSE Ability to use galactose as 2 3 5 Assimilation the sole carbon source dGALf D GALACTOSE Production of gas from 2 3 5 Fermentation fermentation of galactose dGLUf D GLUCOSE Production of gas from 2 5 5 Fermentation fermentation of glucose 3 18 VITEK 2 Systems Product Information 069043 4EN1 YST Product Information Table 3 14 YST Supplemental Tests YST Supplemental Tests Abbreviation Test Name Description Comments Reference w o OIL GROWTH WITHOUT Ability to grow on 2 3 5 OIL Sabouraud Dextrose agar without the addition of a fatty acid source e g olive oil HYPH PH HYPHAE Microscopic examination 2 5 5 PSEUDOHYHPAE for the presence of filaments on morphology agar e g cornmeal agar INOSITOLa myo INOSITOL Ability to use inositol as the 2 5 5 Assimilation sole carbon source NITRATEa NITRATE Assimilation Ability to use potassium 2 5 5 9 nitrate as the sole nitrogen source LACTOSEa LACTOSE Assimilation Ability to use lactose as the 2 5 5 sole carbon source IARABIN a L ARABINOSE Ability to use arabinose as 2 3 5 Assimilation the sole carbon source dMALTOSEa D MALTOSE Ability to use maltose as 2 3 5 Assimilation the sole carbon source dMALf D MALTOSE Production of gas from 2 3 5 Fermentation fermentation of maltose dMELIBIO a D MELIBIOSE
381. rd Inter Message Retries ENG Limit ENG Interval Checksum Limit Checksum Interval Timeouts Checksum r Kemit Configuration p CR LF5 Cem TC es Port uzd O lt ETX gt lt ENO gt POUND D RS M lt EOT gt Packet Sizing LA Pot fcom Number of messages Baud rate 4800 Timeout IER Data Bits E i Party Stop Bits HW Row Control None Serial Port Host Response 10 1 Sunquest Thera 2 Unused Unused 600 600 600 eoo Figure 12 23 Link Configuration Submenu 4 Click on Link Configuration to return to the main Link Configuration COM Manager menu zm Link Configuration COM Manager Supervision Transaction Log D er 1 3 Link Operations Description Clear All Link Configuration Protocol Kemt gt Sunquest e Thera2 BMX Configuration Unused Delays Unused 3 E Tools Ind Moser I zl Inter Record Inter Message 4 Fetes ENQ Limt 5 lt ENQ gt Interval E Checksum Limt gt Checksum Interval E Timeouts Kermit Configuration se oe Pot com3 a T NG Phone number Packet Sizing Timer zl Serial Port pa Number of messages Baud rate E Timeout 500 Data Bis Ji ray PI Stop Bits HW Flow Control IT z Checksum 5 Host Response 3 Sunquest T
382. re a blank CD has been inserted For details on exporting data see Chapter 13 Saving Audit Trail to a CD Exporting Results and Raw Data to Electronic Media For support and troubleshooting ID and AST analysis you can export raw data to a removable media To export Isolate and Raw Instrument Data in the form of a report to electronic media 1 From within the View and Maintain Results view select the isolate s that you want to export 2 Click Export Isolate and Raw Instrument Data Figure 8 20 Export Isolate and Raw Instrument Data Icon 3 Insert a blank CD Note If a CD is not already inserted a message appears asking you to insert a blank CD 4 After you insert the CD the system software validates the CD and copies the raw instrument data and associated isolate information to the CD Sending Biopatterns to SRF Industrial Use Note Any lab tech or supervisor can copy biopatterns to the SRF database however only a supervisor can view and maintain the SRF database information When you review organism identification results and the organism results meet the criteria for SRF you can copy the biopattern to a local database known as the SRF Database The criteria for copying biopatterns to the database depend on the needs of your individual laboratory 8 30 Vi S ITEK 2 Systems Software User Manua 510773 3EN1 View and Maintain Isolate Results Printing Result Reports Note Ifthe identification car
383. re maintains deleted isolate reports in the inactive workspace by removing aged isolate reports The system software applies the following criteria to remove isolates If 21 CFR11 is enabled isolate must be flagged as Archived If an isolate report is determined to be aged from the inactive workspace then the isolate and all related components are deleted Application Audit Trail Management Audit events are maintained by the application in the active and inactive workspace by removing aged audit events The following criteria are used to determine when to remove aged application audit events e If 21 CFR11 is enabled the application audit event must be flagged as Archived If an audit event is determined to be aged from the active or inactive workspace it is deleted Restore Isolate Data Supervisor Only CAUTION Contact bioM rieux support if you need to restore the isolate data Restore should only be performed with help from authorized personnel from bioM rieux Customer Support VITEK 2 Systems Software User Manual 14 7 510773 3EN1 Restore Isolate Data Supervisor Only Data Backup and Daily Maintenance If there is a problem and you need to restore the system data you can do so from the backup CD containing the data This should recover the data from a serious system error The purpose of restoring the system data is to recover the system database The isolate data includes raw data and any user defined custom
384. readily form a smooth suspension in saline it is recommended that a wet swab be used to make the suspension VITEK 2 Systems Product Information 3 3 069043 4EN1 Results YST Product Information Do not rub the agar surface when preparing a suspension using a wet swab Note Age of suspension must not exceed 30 minutes before inoculating card 4 Place the suspension tube and YST card in the cassette 5 Refer to the User Manuals for the VITEK 2 Instruments for instructions on data entry and how to load the cassette into the instrument 6 Follow your local inspecting agency s guidelines for disposal of hazardous waste Results Identification Analytical Techniques The identification of an organism using the VITEK 2 systems uses a methodology based on the characteristics of the data and knowledge about the organism and reactions being analyzed Sufficient data have been collected from known strains to estimate the typical reactions of the claimed species to a set of discriminating biochemicals If a unique identification pattern is not recognized a list of possible organisms is given or the strain is determined to be outside the scope of the database The printed lab report contains suggestions for any supplemental tests necessary to complete the identification If the tests are not sufficient to complete the identification then standard microbiology references and literature should be consulted Certain species may belong
385. relationships among the different phenotypes of Streptococcus dysgalactiae strains Int J Syst Bacteriol 1998 48 1231 1243 Whiley RA Hall LMC Hardie JM Beighton D A study of small colony beta hemolytic Lancefield group C streptococci within the anginosus group description of Streptococcus constellatus subsp pharyngis subsp nov associated with the human throat and pharyngitis Int J Syst Bacteriol 1999 49 1443 1449 bioM rieux Inc Use this Product Information with VITEK 2 Product No 21342 EIRE bioM rieux Inc bioM rieux sa Box 15969 au capital de 11 879 045 Euros Durham North Carolina 27704 0969 USA 673 620 399 RCS LYON tel 1 800 682 2666 69280 Marcy l Etoile France tel 33 04 78 87 20 00 fax 33 04 78 87 20 90 http www biomerieux com Copyright 2005 bioM rieux Inc All rights reserved Vi S 2 25 ITEK 2 Systems Product Information 069042 5EN1 Bibliography GP Product Information 2 26 VITEK 2 Systems Product Information 069042 5EN1 YST PRODUCT INFORMATION 3 Intended Use The VITEK 2 Yeast identification card YST is intended for use with VITEK 2 systems for the automated identification of most significant yeasts and yeast like organisms The VITEK 2 YST identification card is a single use disposable For a list of claimed species see Organisms Identified by the YST Card starting on page 3 14 Description The YST card is based on established biochemic
386. reported as SYN S high level synergy screen is susceptible and SYN R high level synergy screen is resistant VRSA Screen VAS This test may be used to predict the presence of a possible vancomycin resistant Staphylococcus aureus VRSA A positive screen test is highly suggestive of a VRSA The user must confirm the resistance to vancomycin by performing an offline test as recommended by CLSI M100 S 15 vol 25 no 1 January 2005 or the local authorities and or regulatory agency Principle of the Procedure The AST card for VITEK 2 systems is an automated test methodology based on the Minimum Inhibitory Concentration MIC technique reported by MacLowry and Marsh 1 and Gerlach 2 The AST card is essentially a miniaturized and abbreviated version of the doubling dilution technique for MICs determined by the microdilution method 3 Each test card contains 64 microwells A control well that contains only microbiological culture medium is resident on all cards with the remaining wells containing premeasured amounts of specific antimicrobials combined with culture medium The isolate to be tested must be diluted to a standardized concentration in 0 45 saline before being used to rehydrate the card The card is then filled sealed and placed into the instrument incubator reader The instrument monitors the growth of each well in the card over a defined period of time up to 18 hours for bacteria or up to 36 hours for yeast At
387. rint window appears once an isolate has become final and has already been reviewed or approved based on the configuration VITEK 2 technology Figure 10 9 Print Settings 10 8 Vi S ITEK 2 Systems Software User Manual 510773 3ENI Configure and Maintain Workstation Miscellaneous Miscellaneous Setting Up and Creating New Benches Clinical Use The Bench is enabled by default but you can change this in the General Configuration view If Bench Area is disabled it does not appear on laboratory reports or in the general workspace ct tew n Bench 1 at mae 3 Beet Sne 2 42 PM za VITEK 2 technology Figure 10 10 Miscellaneous Settings Add a Bench Name Note 1 To add a bench name click Add A new row appears 2 Place the cursor in the row where you want to add the new bench name 3 Enter a bench name Press Enter to create additional bench names before saving the General Configuration 4 Click Save Delete a Bench 1 To delete a bench name select the bench that you want to delete 2 Click Delete 3 Click Save VITEK 2 Systems Software User Manual 510773 3EN1 10 9 Miscellaneous Configure and Maintain Workstation Modifying Organism Quantity In the VITEK 2 Systems software the Organism Quantity value is a configurable field attached to an individual cassette Modify Organism Quantity Text 1 To modify an Organism Quantity Text field place the cursor in th
388. rkstation when the cassette was loaded in the instrument will be used for the Setup Technologist Name field If 21 CFR 11 is enabled in general configuration the laboratory technologist should be logged into the workstation before loading a cassette Bench Name if enabled in general configuration Note Cassette ID The VITEK 2 Systems software will attempt to identify the Bench Name based on the Bench Name received from a Smart Carrier Station If an exact match case sensitive is not found the system will display You can edit the Bench Name associated with a Smart Carrier Station cassette after the cassette information has been transferred to the workstation To edit the Bench Name 1 From the Set Up Tests Post Entry view select a cassette from the navigation tree The cassette you selected appears in the cassette workspace 2 Select one of the available names from the of Bench Name list 3 After you have entered all of the necessary information into the system software click Save If the Bench Name option is enabled in the general configuration settings the cassette will remain incomplete until a Bench Name is assigned If the system software receives a cassette with a blank Cassette ID entry the workstation will display SCS as the default Cassette ID Note The Cassette ID field cannot be edited VITEK 2 Systems Software User Manual 4 23 510773 3EN1 Setting Up and Entering Quality Control QC Inform
389. rograms gt VITEK 2 Technology gt VITEK 2 Systems software to start the application or double click on the VITEK 2 Technology icon on the desktop Note Only one session of the system software can run at a time 2 Asplash screen appears when the system software initializes Note If the software has recently been restarted it may take several seconds for the VITEK 2 Systems software application to start while it is performing normal database startup operations 2 6 VITEK 2 Systems Software User Manual 510773 3ENI Getting Started Starting the System Software VITEK 2 technology Figure 2 3 Splash Screen Note If an error occurs a message appears describing the error and providing a suggested course of action If the system software is already initialized the splash screen will not appear 3 Login to the system software to begin See Logging In on Page 2 8 for details on logging in to the system 4 When the application starts up the inactivity timer initializes You can customize the inactivity timer See Customize the Inactivity Timer on Page 2 10 for details z e O0OOO o_o VITEK 2 Systems Software User Manual 2 7 510773 3EN1 Logging In Getting Started Logging In When the login window appears follow these steps 1 Type your User ID and press Tab to proceed to the next field 2 Type your Password and click OK or press Enter Please Enter User ID and Password UserI
390. rt appears for the card that you selected 4 Click Print to print the report or click OK to return to the Results view Note When a card under an isolate is printed the Audit Trail report and the Card Detail report are not updated to show this action Detailed Card Report ID and AST Details The AST Card Details report appears displaying details about the AST card processing Ward Details AST Card Details Report Printed Oct 8 2003 1734 lhocession ID 104 1 Card Type AST GN04 Card Lot Number 101288940 Card Expiration Date Now 29 2003 1200 Card Bar Code 11012 8994 0020 9212 instrument Serial Number 10188761 Instrument Name Mtek Date Time of Initial Read sep 29 2003 1509 Date Time of Final Analysis Call Sep 29 2003 2109 Date Time Card Ejected Sep 29 2003 1512 Date Time Last Printed Date Time Last Transferred VITEK 2 compact Software Version BE Cassette ID g Cassette Slot Number a Date Time Cassette Created Sep 29 2003 1506 AES Parameter Set Name ID Card s Card Type BPage toft B85x tin Lal ELE GEN Figure 8 24 AST Card Details Report VITEK 2 Systems Software User Manual 8 55 510773 3EN1 Sending Data to LIS View and Maintain Isolate Results The ID Card Details report prints details about the ID card processing Ward Details ID Card Details Report Printed Oct 8 2003 1735 EH hecession ID 103 3 Card
391. s the system software deletes the patient from the patient workspace Isolate Information Cleanup The system flags aged isolates for removal from the active workspace if they meet the following criteria Not qualified Does not need to be reviewed Does not need to be approved solate is aged according to the number of days configured in General Configuration The system flags the isolates for removal from the active workspace it also removes any other information related to the isolate QC Management Cleanup QC Isolates in the active workspace are flagged as aged and to be removed from the active workspace based on the following criteria Isolate is not qualified Isolate does not need to be reviewed Isolate does not need to be approved Isolate has aged based on the predefined number of days it is allowed to remain in the active workspace as configured in General Configurations For details see Chapter 10 General Configuration If a QC Isolate is determined to be aged from the active workspace then the system flags the QC Isolate and related QC components as inactive and removes them from the active workspace at end of day processing and sends them to the inactive workspace in QC cumulative The inactive workspace database is searched when you conduct a search from the Manage QC view VITEK 2 Systems Software User Manual 14 5 510773 3EN1 End of Day Processing and Daily Maintenance Data Backup and Daily Mai
392. s about all defined connections 1 To view BCI status and alarms click the BCI status icon at the bottom of the screen VITEK 2 Systems Software User Manual 12 21 510773 3EN1 Configure and Maintain BCI View and Maintain BCI Status and Alarms Figure 12 28 BCI Status 2 The BCI Alarm Status and History window appears Note If there is a current alarm the Current BCI Alarm tab appears in front If there are no current alarms the BCI Alarm History tab appears in front WBC Status and Alarm BCI Alarm History Current alarm Report Printed Mar 10 2004 14 17 Mar 10 2004 14 17 GPagetoft El85x110in Z Acknowledge All Messages Figure 12 29 Current BCI Alarms 12 22 VITEK 2 Systems Software User Manual 510773 3EN1 View and Maintain BCI Status and Alarms Configure and Maintain BCI 3 Click on the one of the tabs to view details about the defined connections WBC Status and Alarm Current BCI Alarm Alarm History Report Printed Mar 10 2004 14 19 ne or more of the required specimen tar 9 2004 information fields Mar 9 2004 10 20 lare blank Please Bes 10 24 lenter values in the required fields and retry ne or more of he required specimen Mar 9 2004 information fields tar 9 2004 10 22 lare blank Please piss 10 24 lenter values in the required fields and retry ne or more of the required specimen Mars 2004 information fields 10 28 fare blank
393. s faecium Enterococcus gallinarum Enterococcus hirae Enterococcus raffinosus Enterococcus saccharolyticus Data on file at bioM rieux Inc Vi B 2 13 ITEK 2 Systems Product Information 069042 5EN1 Organisms Identified by the GP Card GP Product Information e Erysipelothrix rhusiopahiae Facklamia hominis Gardnerella vaginalis Gemella bergeri Gemella haemolysans Gemella morbillorum Gemella sanguinis Globicatella sanguinis Globicatella sulfidifaciens Granulicatella adiacens Granulicatella elegans e Helcococcus kunziii Kocuria kristinae Kocuria rosea Kocuria varians Lactococcus garvieae Lactococcus lactis ssp cremoris Lactococcus lactis ssp lactis Lactococcus raffinolactis Leuconostoc citreum Leuconostoc lactis Leuconostoc mesenteroides ssp cremoris Leuconostoc mesenteroides ssp dextranicum Leuconostoc mesenteroides ssp mesenteroides Leuconostoc pseudomesenteroides Listeria grayi Listeria innocua Listeria ivanovii Listeria monocytogenes Listeria seeligeri Listeria welshimeri Micrococcus luteus lylae Pediococcus acidilactici Pediococcus pentosaceus Rothia mucilaginosa Staphylococcus arlettae Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus caprae Staphylococcus carnosus ssp carnosus Staphylococcus chromogenes Staphylococcus cohnii ssp
394. s for the combination antimicrobials are listed on the laboratory and patient reports as the first concentration Example ampicillin sulbactam lt 8 4 pg mL is reported as lt 8 pg mL The actual concentrations for each value in the antimicrobial calling range are as follows amoxicillin clavulanic acid ug mL 2 1 4 2 8 4 16 8 32 16 e ampicillin sulbactam ug mL 2 1 4 2 8 4 16 8 32 16 piperacillin tazobactam pg mL 4 4 8 4 16 4 32 4 64 4 128 4 ticarcillin clavulanic acid ug mL 8 2 16 2 32 2 64 2 128 2 trimethoprim Sulfamethoxazole Note exception This drug is listed on the laboratory and patient reports as the sum of the two antibiotic concentrations 20 pg mL 1 19 40 pg mL 2 38 80 pg mL 4 76 160 pg mL 8 152 320 pg mL 16 304 VITEK 2 Systems Product Information 6 11 510774 3EN1 Limitations Susceptibility Product Information Antibiotic Deduction Deduced antibiotics only report an interpretive result and are noted with a For specific information regarding equivalent and or phenotypic deductions refer to the online user manual Suppression of Results Clinical Efficacy A result for an organism antimicrobial combination which may have a limitation listed in the package insert e g performance issues may be suppressed from reporting Refer to the online user manual for a description and instructions about suppression of results There are antimicrobials included o
395. s in the required fields and retry r 9 2004 Lab Super o i D Page 1 of 9 E 8 5x11 0 in Figure 12 32 BCI Alarm History BCI Configuration Settings From the Main view follow these steps to Configure BCI 1 Click Configuration and select BCI Configuration from the drop down list 2 The General BCI Configuration view appears 3 Select the desired connection interface Note The connection must be previously defined in Link Configuration VITEK 2 Systems Software User Manual 12 25 510773 3EN1 Configure and Maintain BCI BCI Configuration Settings WAC Configuration EKAHKOC KACHS E REESE CETT O Une Frond Lab D Wet Lab D System Code Suture Type Code Marine Lab D Vict laca e Type He Test Separator g quuguuduguduguuaguuuuuuaumdauu f vs VITEK 2 technology Figure 12 33 BCI Configuration View 4 Ifyou are a supervisor you can unlock this view and make any necessary configuration changes Note A Kermit port will not have the COM port listed in parenthesis Note When you select Send to LIS in View and Maintain Isolate Results the data is sent to all the ports listed in the connection interfaces When creating a new port exit the screen by clicking on another view for example Main view and then return to the BCI Config window to see the new port General BCI Configuration Settings Character Set Select the
396. s mitis Streptococcus oralis Streptococcus mitis Streptococcus oralis Identification Card Qualifying Messages Table 2 2 Identification Card Qualifying Messages ID Message Confidence Level Choices Probability Comments Excellent 1 96 to 99 Very Good 1 93 to 95 Good 1 89 to 92 Acceptable 1 85 to 88 Low Discrimination 2 to 5 Sum of choices 2 to 3 taxa exhibit same biopattern 100 after Separate by supplemental testing resolution to one choice percent probability reflects the number associated with selected choice Must resolve to mate with susceptibility card Unidentified gt 3 n a Either gt 3 taxa exhibit same biopattern Organism or or 0 Very atypical biopattern Does not correspond to any taxon in the database Check Gram stain and purity Percent Probability As part of the identification process the software compares the test set of reactions to the expected set of reactions of each organism or organism group that can be identified by the product A quantitative value the percent probability is calculated and relates to how well the observed reactions compare to the typical reactions of each organism A perfect match between VITEK 2 Systems Product Information 2 5 069042 5EN1 Additional Information on the Lab Report GP Product Information the test reaction pattern and the unique reaction pattern of a single organism or organism group would
397. sehleib1 Created Isolate Oct 2 2003 1224 1044 Created jschleibi Created Isolate Created Oct 2 2003 1224 103 1 schleibt Oct 2 2003 1223 1041 schleibt Modified Analysis Completes Created Isolate Oct 2 2003 1224 104 1 Created schleibT IModified Analysis Completes Oct 8 2003 1733 1041 schleib 1 loot 8 2003 1733 1044 prei schleibt Escherichia coli Oct 2 2003 1224 03 3 Crested isolate Let Elasxitin VITEK 2 technology Figure 13 10 Audit Trail Reports VITEK 2 Systems Software User Manual 13 17 510773 3ENI Print Audit Trail Reports System Utilities 13 18 VITEK 2 Systems Software User Manual 510773 3ENI DATA BACKUP AND DAILY MAINTENANCE 4 About This Chapter This chapter describes end of day processing for the system software All of the end of day processing is carried out by the system software This chapter describes the automatic nightly maintenance and backup that occur without requiring any action by a Laboratory Technologist or Supervisor Chapter Contents Backup Isolate Data 14 2 Recommended Backup Strategy 14 2 Automatic Backup 14 3 CD Failure 14 5 Laboratory Technologist Initiated Isolate Data Backup 14 5 End of Day Processing and Daily Maintenance 14 4 Complete Daily Workspace Maintenance 14 4 Maintain Inactive Workspace 14 6 Restore Isolate Data Supervisor Only 14 7 Restore
398. seria sicca Oligella urethralis Suttonella indologenes Da O NITEV gt Ceta me Dol labs 4 14 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information NH Well Contents NH Well Contents Table 4 13 NH Well Contents Well Test Mnemonic Amount Well 1 Arginine ARYLAMIDASE ArgA 0 0324 mg 2 GAMMA GLUTAMYL TRANSFERASE GGT 0 0228 mg 3 L Lysine ARYLAMIDASE LysA 0 0228 mg 4 D GALACTOSE dGAL 0 3 mg 5 Leucine ARYLAMIDASE LeuA 0 023 mg 6 ELLMAN ELLM 0 03 mg 7 Phenylalanine ARYLAMIDASE PheA 0 026 mg 8 L Proline ARYLAMIDASE ProA 0 023 mg 10 L Pyrrolydonyl ARYLAMIDASE PyrA 0 018 mg 13 Tyrosine ARYLAMIDASE TyrA 0 0279 mg 15 Ala Phe Pro ARYLAMIDASE APPA 0 038 mg 18 D GLUCOSE dGLU 0 3 mg 19 GLYCOGENE GLYG 0 18 mg 20 D MANNOSE dMNE 0 3 mg 22 D MALTOSE dMAL 0 3 mg 28 SACCHAROSE SUCROSE SAC 0 3 mg 33 N ACETYL D GLUCOSAMINE NAG 0 3 mg 36 UREASE URE 0 15 mg 39 BETA GALACTOPYRANOSIDASE Indoxyl BGALI 0 006 mg 40 ORNITHINE DECARBOXYLASE ODC 0 15 mg 41 ALPHA ARABINOSIDASE AARA 0 0324 mg 45 PYRUVATE PVATE 0 15 mg 46 PHOSPHORYL CHOLINE PHC 0 0366 mg 47 D MALATE dMLT 0 15 mg 51 MALTOTRIOSE MTE 0 3 mg 52 L GLUTAMINE IGLM 0 15 mg 59 PHOSPHATASE PHOS 0 05 mg 61 D Ribose 2 dRIB2 0 3 mg VITEK 2 Systems Product Information 415 532511 4EN1 NH Well Contents NH Product Information Table 4 13 NH Well Contents Well
399. sistance Therapeutic Interpretation Changes e Global Phenotypic Consists of Global CLSI CA SFM or Manufacturer breakpoints with Phenotypic Therapeutic Interpretation Changes Industry CLSI breakpoints with CLSI Therapeutic Interpretations with biologic validation disabled CLSI CLSI breakpoints with CLSI Therapeutic Interpretations e CLSI Natural Resistance CLSI breakpoints with CLSI and Natural Resistance Therapeutic Interpretations You cannot change the predefined standard parameter sets but if you are a Supervisor you can make a copy of a predefined parameter set to create a new custom parameter set For details see Creating a Custom Parameter Set on page 11 10 VITEK 2 Systems Software User Manual 11 5 510773 3EN1 AES Configuration View View and Configure AES AES Configuration View When you select a parameter set the following AES Configuration information pertaining to the selected parameter set appears in the workspace natin kope vaiston Maxmom MK corrections I Fret Forcing Rues MIC Interpretations OLS MTOO 515 2005 RTE Therapeutic interpretatione LS M100 515 2005 7 atio Deduction tuj Peeeetypa Grate Deduction by Catenin Artistic Figure 11 4 AES Configuration View AES Parameter Set Definition Name Name of the standard or custom must be unique parameter set Description Information that further describes the pa
400. sms for Automatic Slashline Resolution Set Time to Eject Analyzed Cards Note To enable SRF you must select Industry mode from the General Configuration view and select the Enable SRF check box from ID Configuration WG Configuration F Bacius coeur Bocau thunngensia F Bachus Designs pactus cereusitiectus runngensis e f None C Docus tohwencusDecitur futifoma Bacillus tusitormis Pacaus spheencuskiscius tusitormes C Bacan sphaericus None Bacilut puteis Dach smykiquetocens C acus m er pactus a scdut amyiokquetaciens C Bacan nitis Mone Figure 9 1 Configure ID Analysis View and Maintain ID Analysis When you select ID Configuration view you can view and modify the Identification settings 9 2 VITEK 2 Systems Software User Manual 510773 3EN1 Configure Results Analysis and Review Configuring AST Analysis Selecting Organisms for Automatic Slashline When you configure the identification analysis parameters you have the option to change the automatic slashline resolution for one or more slashline organism groups 1 From within ID Configuration view unlock the view to make changes 2 Use the list and scroll to navigate to the slashline organism group that you would like to change 3 Make any necessary changes 4 Be sure to save and lock your changes before moving on to another view Enabling SRF Analysis Industry Use SRF Analysis is used in Industry Mode only
401. sor Comments Makes a Required Change Supervisor No Review or Approve p Customer J Change Send to LIS all isolates Makes a Comments Change Required Figure 8 11 Result Validation Configurations VITEK 2 Systems Software User Manual 8 17 510773 3EN1 ID Card Details View and Maintain Isolate Results ID Card Details View Detailed Biochemical Results Note Card status must be final to view biochemical results For details on the biochemical reactions refer to the Online Product Information for a specific card type VW View and Maintain Isolate Results AES Findings Consistert Phenotypes Selected for Rewew None Detected o BR 108 1 Low Discrimo St KE DH pre NOGA lt Low Diseria v 11041 B temas S v 111 1 Pe porine JU 112 1 lt eStarrine gt v BE 1131 c lt Siosr nens y 201 1 Esch cel ASTON Pina 26 v 20241 Ertero teecium AST CESS Fra iv 26 y 203 1 Esch cel ASTOMA fini Nov 26 v 204 1 Pt aerer AST GNIO Final Nov 26 v 205 1 Ctro freuncti AST ONDA Final Nov 28 v 208 1 Staph sures AST GP55 Final Nov 26 V 207 1 Ertero soss AST OPSS Fri Now 26 v 206 1 Sy preumorise ASDPSOS Fins Nov 26 M 200 1 Congiase neg Staph o Ii 301 1 axytoce S Bl 401 1 Liridertifid B B 40241 lt crwertina gt gt Figure 8 12 View ID Card Details When you want to view isolate result details for a fina
402. ssimilation IPROa 0 15 mg 62 2 KETO D GLUCONATE assimilation 2KGa 0 15 mg 63 N ACETYL GLUCOSAMINE assimilation NAGa 0 15 mg 64 D GLUCONATE assimilation dGNTa 0 15 mg Note Other well numbers between 1 and 64 not designated in this table are empty VITEK 2 Systems Product Information 3 17 069043 4EN1 YST Supplemental Tests YST Supplemental Tests YST Product Information Table 3 14 YST Supplemental Tests Abbreviation Test Name Description Comments Reference 2KG 2 KETO D Ability to use 2 keto D 2 3 5 GLUCONATE gluconate as a sole carbon source 4ASCOSPOR 4 Ascospores Microscopic examination 2 3 5 for the presence of four ascospores per ascus Apic CELLS APICULATE CELLS Microscopic examination 2 3 5 for the presence of apiculate lemon drop shaped cells Arthro Arthroconidia Microscopic examination 2 3 5 for the presence of arthroconidia fragmentation of hyphae into rectangular cells on morphology agar eg cornmeal agar CAROTENOID CAROTENOID Presence of red pink or 2 3 5 PIGMENT orange pigment on Sabouraud Dextrose agar dCELLOB a D CELLOBIOSE Ability to use cellobiose as 2 3 5 Assimilation the sole carbon source CHLS Chlamydospores Microscopic examination 2 3 5 for the presence of chlamydospores on morphology agar eg cornmeal agar DULCITOLa DULCITOL Assimilation Ability to use dulcitol 2 3 5 galactitol as the sole carbon sou
403. st VITEK 2 Systems Product Information 5 19 069045 2EN1 BCL Supplemental Tests BCL Product Information Table 5 16 BCL Supplemental Tests Abbreviation Test Name Description Comments Reference ESCULIN Esculin hydrolysis Hydrolysis of esculin yields 1 3 esculetin which forms a brown black complex with ferric ions GELATIN Gelatin hydrolysis Liquefaction of gelatin is 1 2 3 6 mediated by the proteolytic enzyme gelatinase releasing a black pigment which diffuses throughout the tube GRAM Gram positive Differential stain used to Only one organism 1 2 5 6 demonstrate the staining on the BCL card properties of bacteria stains Gram Organisms stain Gram negative positive Brevibacillus invocatus All other organisms are Gram positive Young cultures should always be used to avoid Gram variable results often obtained with older cultures gt 24 hours IND Indole Metabolism of tryptophan 1 2 results in the production of indole which forms a pink red color with p dimethylaminobenzaldehy de eg Kovac s reagent 5 20 VITEK 2 Systems Product Information 069045 2EN1 BCL Product Information BCL Supplemental Tests Table 5 16 BCL Supplemental Tests Abbreviation Test Name Description Comments Reference LACTATEa DL lactate Ability to use DL lactate 5 6 assimilation IRHAMNOSE L rhamnose Acid produced from the Some tests
404. st cards between isolate groups 8 26 report results of ID and AST tests 8 51 reports validation information 8 31 results status is final 6 3 send data to LIS 8 35 test results organized by 8 3 view additional information 8 11 AES findings 8 11 analysis messages 8 11 analysis status 8 11 AST offline tests 8 11 ID confidence 8 11 isolate number 8 1 1 laboratory identification number 8 11 organism 8 11 patient specimen information 8 11 review status 8 11 test results 8 11 L Isolate Number definition 4 9 Isolate Results change additional information organism quantity 8 14 create view batch results 7 10 from navigation tree 8 3 reanalyze results 8 38 review 8 39 review more than one isolate at a time 8 39 right view bar buttons 8 8 view additional detailed information 8 8 Isolates aged 5 8 archive to CD 13 10 archived isolate audit 13 11 critical 9 6 eligible for archive 13 9 flagged to be removed from active workspace 14 4 move isolates to inactive 10 7 QC isolates flagged as aged 14 4 qualified 5 5 search audit trail 13 13 transaction log 12 7 Lab ID links isolate and patient information 5 5 Lab ID Number 4 8 Lab Report 8 30 facility name on 10 6 Laboratory Information System See LIS Laboratory Supplies 1 2 Left View Bar Buttons 8 4 Link ID card to AST card 4 10 isolate to patient specimen information 5 5 specimen to existing isolate 5 5 Link Configuration COM Manager Window 12 15 Link Configuration Scree
405. status information View Instrument Monthly Status To view a cumulative history of the selected instrument parameters you can view the monthly status Note The system software stores temperature and optic readings for four months the current month plus three previous months When the status readings surpass four months they are automatically removed from the system software 3 4 VITEK 2 Systems Software User Manual 510773 3EN1 Instrument And System Status VITEK 2 Systems Software User Manual 3 5 510773 3EN1 View Instrument Monthly Status To view the monthly status 1 From any view click the Instrument Status icon at the bottom of the screen Walarm Messages instrument Status Current Alarm Alam History Current Instrument Status Monthly instrument Status Instrument Simulator 19563490 Mont January 2004 Mormal ES Ranges iamen Gender 1000300 MarghJaumy 2004 Noma Tempermure HIC mes OK gt SEET Date DPagetot Fesxiioin Lal ED E Z VITEK 2 technology Figure 3 6 Monthly Instrument Status 2 Select the Monthly Instrument Status tab 3 If there are multiple instrument connections select the instrument that you want to view from the drop down list 4 Select a month to view the status of the instrument from the drop down list 5 The system software displays the following information for the instrument for the selected month Normal tempe
406. ta and proceed with restore isolate data 8 When restore completes the lab supervisor is notified that the data was successfully restored 9 Click OK The system reboots and the system software starts up automatically 10 To begin using the software you will need to log in again 14 8 VITEK 2 Systems Software User Manual 510773 3ENI Data Backup and Daily Maintenance Restore Isolate Data Supervisor Only Restore Failure If restoring isolate data fails the workstation displays a message noting the reason for failure Once you acknowledge the failure contact bioM rieux for assistance VITEK 2 Systems Software User Manual 14 9 510773 3EN1 Restore Isolate Data Supervisor Only Data Backup and Daily Maintenance 14 10 VITEK 2 Systems Software User Manual 510773 3ENI APPENDIX A BLANK CASSETTE WORKSHEET A VITEK 2 Compact Blank Cassette Worksheet General Information Instrument Name Setup Date Time Cassette Information Cassette ID Bench Name Setup Tech Name Dilution Mode Isolate Offline Tests and rganism VITEK 2 Systems Software User Manual A 1 510773 3EN1 VITEK 2 Blank Cassette Worksheet Appendix A Blank Cassette Worksheet VITEK 2 Blank Cassette Worksheet General Information Instrument Name Setup Date Time Cassette Information Cassette ID Bench Name Setup Tech Name Dilution Mode A 2 VITEK 2 Systems Software User Manual 510773 3EN1 APPENDIX B
407. task you need to perform The table of contents is one method for finding the topic you need you can also search for a keyword by using the Adobe Reader search function or by scrolling to the Index of this book This user manual also contains a Glossary with brief descriptions of words that may be unfamiliar For more detailed help on viewing and searching for topics within a PDF file refer to Adobe online user documentation Typographic and Usage Conventions Several common typographic conventions are used to distinguish important words displayed on the screen or references to other sections The following typographic conventions are used throughout this manual Genus and Species Names VITEK 2 Systems Software User Manual 1 5 510773 3EN1 Family names as well as genus and species names of bacteria are italicized Example Enterobacteriaceae Example Clostridium novyi or Agrobacterium radiobacter tumefaciens Typographic and Usage Conventions How to Use This Manual References References to other sections in this manual are shown in blue These are hyperlinks within the PDF manual Example See Chapter 13 System Utilities for more information on resetting security settings Click The term click refers to moving a mouse pointer to choose or select a command window button icon or option then pressing the left or primary mouse button to initiate action in the software Example Click OK Commands Menu keybo
408. te hemolysis resulting in a green zone around colonies on blood based media Acidification of Acidification of carbon Some tests also 2 5 4 6 8 11 AMD STARCH AMIDON STARCH source observed with appear on the GP 13 14 17 18 GLYCOGENac GLYCOGEN pH indicators e g card but are 19 21 22 24 IARABINOSE IARABINOSE phenol red bromocresol recommended as 25 INULIN INULIN purple etc supplemental MdG METHYL A D tests since results GLUCOPYRANOSIDE of conventional MdM METHYL A D macromethods MANNOPYRANOSIDE often differ from PULLULAN PULLULAN rapid commercial SACCHAROSE SACCHAROSE SUCROSE micromethods dMALTOSE D MALTOSE dMANNITOL D MANNITOL dMANNOSE D MANNOSE dMELEZIT D MELEZITOSE dMELIBIOSE D MELIBIOSE dRAFFINOSE D RAFFINOSE dRIBOSE D RIBOSE dSORBITOL D SORBITOL dTREHALOSE D TREHALOSE dXYLOSE D XYLOSE IRHAMNOSE L RHAMNOSE ANANE ALPHA D N Presence of respective Presence of 5 9 17 18 19 ACETYLNEURAMINIDASE enzyme cleaves enzyme is 21 22 24 28 AIFUC ALPHA L FUCOSIDASE substrate generating indicated by BGLU BETA GLUCOSIDASE detectable leaving group generation of a BGURase BETA GLURONIDASE e g p nitrophenol colored or BNAG BETA N ACETYL methyl umbelliferone fluorescent GLUCOSAMINIDASE beta naphthylamide product or a non BNAGA BETA N ACETYL beta naphthol colored product GALACTOSAMINIDASE p nitroaniline 7 amido that forms color BdFUC BETA D FUCOSIDASE methyl coumarin etc
409. tely customize the guideline Modifying Breakpoints for a Custom Interpretation Guideline To modify the interpretation guideline name you must be on a custom parameter set You can make the following changes Update a breakpoint value with a new value Add a breakpoint value Remove a breakpoint value VITEK 2 Systems Software User Manual 11 13 510773 3EN1 Viewing MIC Interpretation Guideline View and Configure AES Updating a Breakpoint To modify breakpoints 1 Select an existing breakpoint Note A blank value means there is no known value for that MIC value 2 Make a change to the MIC value of a breakpoint by selecting from the list of MIC values proposed by the system software 3 Save the change Note Customized information appears highlighted Wain View MIC inter pretation Guideline Knowledge Base Version 1 0 Oct 8 2003 5 01 27 PM Mame EMC NOCLS M100 512 Jan 2002 Parameter Set Status inactive Based One NCCLS M100 12 Jan 2002 sort by forgenam artbete D reg z P a Figure 11 12 Modify Breakpoints Adding a Breakpoint Set If you need to update the breakpoints for a custom parameter set you can add breakpoints 1 Select the breakpoint 2 Click the Add Sign icon to add a Breakpoint Set 3 The system software displays the following Organism hierarchy 11 14 VITEK 2 Systems Software User Manual 510773 3EN1 View and Configure AES Viewing MIC Interpreta
410. tems Product Information for the particular card type Viewing Cassette Information When you are in the Set Up Tests Post Entry view you can view the cassettes and their status Any cassettes that need more information to complete VITEK 2 Systems Software User Manual 4 5 510773 3EN1 Defining the Selected Cassette Set Up Test Cards and Cassette Information Note analysis will appear with a Needs Info status The following text representations and definitions will help you understand the cassette status Loaded Cassettes Virtual Cassettes and Smart Carrier Station Cassettes with incomplete information are displayed in red Table 4 1 Cassette Status Descriptions Color Description Red Text Needs Info Cassette needs more information to process the test cards Black Text Cassettes that are complete and ready to process test cards A cassette that needs more information to completely process the tests cards may be unable to process for the following reasons Accession Number not defined Virtual Cassette Reconciliation Problems include Missing card Extra card Wrong Card The messages are listed under the Messages column in the Set Up Tests workspace area Defining the Selected Cassette To select a specific cassette 1 From the Set Up Tests Post Entry view select a cassette from the navigation tree The cassette you selected appears in the cassette workspace 2 When you select a
411. terobacteriaceae are oxidase negative PURPLE PURPLE PIGMENT Ability of certain Characteristic of 11 species to produce Chromobacterium purple colonies on violaceum non differential media PYOCYANIN PYOCYANIN pigment Ability of species to Presence of both 1 11 PYOVERDIN PYOVERDIN pigment produce blue pyocyanin and pigment pyocyanin pyoverdin is or fluorescent characteristic of pigment pyoverdin Pseudomonas aeruginosa producing greenish fluorescent colonies UREASE Urease Hydrolysis of urea 6 8 9 11 15 releases ammonia 17 resulting in alkalinization of the medium observed with a pH indicator e g red color formation in the presence of phenol red VP VOGES PROSKAUER Ability of some 11 9 8 15 species to produce acetoin from glucose fermentation YELLOW YELLOW PIGMENT Ability of certain 8 9 11 17 species to produce yellow pigmented colonies on non differential media VITEK 2 Systems Product Information 1 23 069041 4EN1 Culture Requirements Table Culture Requirements Table GN Product Information Table 1 14 Culture Requirements VITEK 2 Card Media Age of Culture Incubation Conditions Inoculum Density Dilution for AST Age of Suspension Before Loading Instrument GN TSA CBA MAC BCP CET CLED CHOC CHOC PVX CHBA CNT CPS ID3 DENA DRIG HEK TSAHB TSAB TSAL VRBG XLD 18 to 24 hours 35 C to 37 C Aerobic non CO5 0 50 to 0 63
412. ters You will be prompted to enter a file name Print Configuration Enables you to print and archive connection parameters 12 20 VITEK 2 Systems Software User Manual 510773 3ENI View and Maintain BCI Status and Alarms Configure and Maintain BCI BCI Alarm Status Icons OK The icon with the green square means the connection with external data management system is okay Click this icon to see the connection status Figure 12 25 Connection OK Status Warning The icon with the orange triangle indicates a problem with the data management system Click this icon to see the status of the connection and a description of the warning Figure 12 26 Connection Warning Status Error The icon with the red circle indicates an error in the BCI connection Click this icon to see a description of the error condition Figure 12 27 Connection Error Status View and Maintain BCI Status and Alarms Viewing and maintaining BCI status and alarms allows a Laboratory Technologist or Laboratory Supervisor to determine the current state of system software interface connections BCI Status and Alarms can be viewed from any screen within the system software BCI Alarm history allows you to view the current status of connections and execute some troubleshooting techniques If an alarm condition is detected clicking on the status indicator will display the BCI alarm history window At any time you can select the BCI Status icon to view detail
413. the card by selecting Yes or No 5 If you select Yes the card is ejected from the instrument Reanalyzing Isolate Results When you make changes to any of the isolate results you can also reanalyze the results To do so click the Reanalyze icon Note You cannot reanalyze an isolate group with only an ID card and SRF disabled Figure 8 31 Reanalyze Results VITEK 2 Systems Software User Manual 8 39 510773 3EN1 Review and Approve Results Configuration View and Maintain Isolate Results Review and Approve Results Configuration When results become final you may need to review or approve them before the results are sent to the LIS Reviewing Results Results are stopped for review depending on how the results validation is configured for your lab For Results Validation Configuration details see Chapter 9 Results Validation Configuration To review results 1 From the View and Maintain Isolate Results view select an isolate from the navigation tree 2 Ifthe result status is To be Reviewed and you agree with the result click the Review icon Note If Electronic Signature is enabled enter your Password to review an isolate Figure 8 32 Review Results Reviewing Batch Results To review more than one isolate at a time 1 From the View and Maintain Isolate Results view select one or more isolates 2 To select and review more than one isolate hold down the Shift key and select the consecutive is
414. the instrument can match the Virtual Cassette with the Actual Cassette This process is known as reconciliation For details on viewing reconciliation details see Viewing Reconciliation Details on page 4 19 When you create a new Virtual Cassette the blank virtual cassette workspace appears in the cassette workspace The blank workspace displays all 10 cassette slots and input fields for each slot To begin setting up the Virtual Cassette 1 From the Set Up Tests Post Entry window click the Maintain Virtual Cassette icon located in the left view bar 4 16 VITEK 2 Systems Software User Manual 510773 3ENI Set Up Test Cards and Cassette Information Using the Virtual Cassette Workflow Whaintain Virtual Cassette VITEK 2 technology Figure 4 13 Maintain Virtual Cassette 2 Click the Create New Virtual Cassette icon Figure 4 14 Create New Virtual Cassette VITEK 2 Systems Software User Manual 4 17 510773 3EN1 Using the Virtual Cassette Workflow Set Up Test Cards and Cassette Information 3 The Virtual Cassette workspace area appears Whaintain Virtual Cassette HOER CR ES EC 2100 1 WC 2410100OMOBTIS O 21012 VITEK 2 tochnology Figure 4 15 Virtual Cassette Workspace 4 Select a Cassette ID from the list of available Cassette IDs The default Cassette IDs available are Cassette 1 through Cassette 9 5 Select your name from the Setup Tech drop down menu Note lf21 CFR
415. the procedure for patient isolates outlined in this document VITEK 2 Systems Product Information 6 9 510774 3EN1 Quality Control Susceptibility Product Information Frequency of QC Testing as defined by CLSI Refer to the CLSI Reference Guide document number M7 A6 Testing and Storage of QC Organisms All organisms except yeast Yeast Rehydrate the organism according to the manufacturer s instructions Subculture to Trypticase Soy Agar with 5 sheep blood TSAB Incubate at 55 C for 24 hours Gram positive organisms may require a 3 to 5 CO atmosphere Check for purity Subculture to a TSAB plate Incubate 16 to 18 hours at 35 C Rehydrate the organism according to the manufacturer s instructions Subculture to Sabouraud Agar SAB or Sabouraud Dextrose Agar SDA Incubate at 35 C for 24 hours Check for purity Subculture to a SAB or SDA plate Incubate at 35 C for 24 hours Candida species or 48 hours Crytococcus neoformans Storage Conditions for QC Organisms Short Term Storage 1 Streak to a TSAB plate or slant SAB or SDA for yeast 2 Incubate for 24 hours 3 Refrigerate at 2 C to 8 C for up to two weeks 4 Subculture once as described above and use for QC Long Term Storage 1 Make a heavy suspension in Trypticase Soy Broth TSB with 15 glycerol 2 Freeze at 70 C 6 10 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Prod
416. tic microtechnique for serial dilution antibiotic sensitivity testing in the clinical laboratory J Lab Clin Med 72 685 687 2 Gerlach E H 1974 Microdilution 1 A Comparative Study p 63 76 In Balows A ed Current Techniques for Antibiotic Susceptibility Testing Charles C Thomas Springfield IL 3 Barry AL 1976 The Antimicrobic Susceptibility Test Principles and Practices Lea and Febiger Philadelphia PA 4 Murray PR EJ Baron M A Pfaller F C Tenover and R H Yolken ed 1999 Manual of Clinical Microbiology 7th ed American Society for Microbiology Washington D C 5 National Committee for Clinical Laboratory Standards Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically M7 A6 Wayne Pennsylvania January 2003 6 Clinical and Laboratory Standards Institute Performance Standards for Antimicrobial Susceptibility Testing Fifteenth Informational Supplement M100 S15 Vol 25 No 1 January 2005 7 Comit de l Antibiogramme de la Soci t Francaise de Microbiologie Communiqu 1996 Path Biol 1996 44 n 8 I VIII 8 Comit de l Antibiogramme de la Societe Francaise de Microbiologie Communiqu 2004 9 National Committee for Clinical Laboratory Standards M29 A Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline 1997 10 U S Department of Hea
417. tion Guideline Antibiotic hierarchy Infection Site list 4 Indicate which breakpoint you want to add from the lists of available Organisms Antibiotics and Diagnosis 5 To expand the organism hierarchy double click the selection Only one of each can be set at one time 6 Click Next to go to the next list Note If you do not want to differentiate breakpoints by diagnosis select other diagnoses 7 The system software makes the updates when you save the changes 8 Now you can access the values of the new breakpoint set Delete Breakpoint Set 1 Select the breakpoint set that you want to delete and click Delete 2 Confirm the deletion Sorting Information The status of the parameter set appears in the workspace area You can sort the displayed data by choosing the corresponding value of the Sort By drop down menu Note You can also choose the order of the columns using drag and drop Dragging and dropping the columns has no impact on the sorting of the data contained in each column VITEK 2 Systems Software User Manual 11 15 510773 3EN1 Viewing Therapeutic Interpretation Guideline View and Configure AES Viewing Therapeutic Interpretation Guideline To find the Therapeutic Interpretation Guideline for a parameter set 1 Click on either a predefined or custom parameter set 2 Select Therapeutic Interpretation Guideline 3 The information appears in the workspace area Note If the current guidelin
418. tion method Testing and Storage of QC Organisms Rehydrate organism according to the manufacturer s instructions Use Trypticase Soy with 5 sheep blood agar TSAB and incubate at 35 C to 37 C in aerobic 596 to 1096 CO for approximately 18 to 24 hours Check for purity Perform second subculture for testing Storage Conditions Short Term Storage 1 Subculture to a TSAB plate or slant 2 Incubate for 24 hours at 35 C to 37 C 3 Refrigerate at 2 C to 8 C for up to two weeks 4 Subculture once as described above and use for QC Long Term Storage 1 Make a heavy suspension in Tryptic Soy Broth with 15 glycerol 2 Freeze at 70 C 3 Subculture to TSAB twice before running QC 2 8 VITEK 2 Systems Product Information 069042 5EN1 GP Product Information GP Quality Control Table Note Avoid repeated thawing and refreezing by either freezing in single use aliquots or removing a small portion of frozen organism preparation with a sterile applicator stick GP Quality Control Table Enterococcus casseliflavus ATCC 700327 Kocuria kristinae ATCC BAA 752 Listeria monocytogenes ATCC BAA 751 Staphylococcus aureus ssp aureus ATCC 29213 Staphylococcus saprophyticus ATCC BAA 750 Staphylococcus sciuri ATCC 29061 Streptococcus equi ssp zooepidemicus ATCC 43079 Streptococcus thermophilus ATCC 19258 The organisms below marked with an asterisk indicate additional quality control if required by local reg
419. tion of a lt NACK gt in response to the checksum or if no response is received Timeouts Checksum Timeout Amount of time BCI waits before 0 to 99 3 retransmitting the packet following reception of a lt NACK gt in response to the checksum or if no response is received Host Response Timeout Time allowed by BCI for the host 0 to 99 10 to respond when BCI is expecting data when a session has been opened by the LIS When this time expires BCI closes the session by sending an lt EOT gt BCI also records an error message 12 18 VITEK 2 Systems Software User Manual 510773 3ENI Link Configuration Configure and Maintain BCI Table 12 1 Configuration Parameters Parameters Description Possible Values Default lt CR gt lt LF gt Note If these are enabled for uploads they will also be required for download packets lt STX gt Start of transmission enabled disabled disabled lt ETX gt End of transmission enabled disabled disabled lt RS gt Record Separator enabled disabled disabled GS Checksum enabled disabled disabled lt ENQ gt Line Request Character enabled disabled disabled lt EOT gt End of transmission enabled disabled disabled Serial Port Port Serial port used by the link Between COMI and COMI COM4 Baud rate Transfer speed Between 110 and 4800 256000 baud Data bits Number of bits per character Between 4 and 8 bits 8
420. tions For details see Viewing AES Graphic Clinical Use on page 8 25 or Viewing Detailed AES Report Clinical Use on page 8 24 Possible AES Findings After analysis is performed the results are expertized based on the AES Configuration parameters set up for your laboratory For details see Chapter 11 Accessing AES Configuration The AES Findings are displayed in the upper right corner of the View and Maintain Results view Phenotypes selected for review The phenotypes detected by AES are displayed in the window if they are configured or selected to stop for review in the Result Validation Configuration For details see Chapter 9 Results Validation Configuration AES provides the following levels of confidence in the response returned TABLE 8 7 AES CONFIDENCE LEVELS Icon Confidence Level Description Consistent One or more phenotypes detected with no changes to MIC values Therapeutic Changes may also be Green detected Consistent with One or more phenotypes detected E Corrections when including an MIC value change or a test value change in the AES analysis The tested MIC value or test value is reported Therapeutic changes may also be detected NOTE A correction to an MIC value or a correction to a test i e beta lactamase ESBL etc will result in an AES confidence of Consistent with Corrections Yellow Inconsistent Phenotypes cannot be detected Antibiogram is inconsistent with the Red
421. to display the work window Note To access the Link Configuration menu you must log in as a supervisor 3 The Link Configuration COM Manager window displays Z Link Configuration COM Manager DER 4 Supervision e Transaction Log Link Operations s Link Configuration Tools Link Name Status Upload Download Host Configuration VITEK Unused Unused Unused STARTED STOPPED STOPPED STOPPED ENABLED ENABLED BACK IN SERVICE ENABLED ENABLED BACK IN SERVICE DISABLED DISABLED BACK IN SERVICE DISABLED DISABLED BACK IN SERVICE bioM rieux Literal COM 961 bioM rieux Literal COM 481 bioM rieux Literal COM 481 bioM rieux Literal COM 481 VITEK svo Figure 12 22 Link Configuration Unused Unused Unused eoo 800 600 Note These parameters must be set taking into account the characteristics of the connection protocol developed by your computer company For further information call bioM rieux Global Customer Support VITEK 2 Systems Software User Manual 12 15 510773 3EN1 Configure and Maintain BCI Z Link Configuration COM Manager Link Configuration BE Supervision amp Transaction Log Link name IESSE l Link Operations Ei 9 Link Configuration Protocol bioM rieux Literal Sunquest e Thera2 m BMX Configuration Description Unused Delays Unused Last Master Tools Inter Reco
422. ttes into the instrument see the corresponding Instrument User Manudl Using the Set Up Tests Post Entry Workflow When the cassettes have been loaded into the instrument and the cards have been scanned the cassette appears on the Set Up Tests Post Entry view Note lf21 CFR 11 is enabled VITEK 2 Compact you must be logged on to the system to process cassettes in the Set Up Tests Post Entry workflow To access the Set Up Test Post Entry view 1 From the Main view click the Enter Manage Cassettes view icon Ka Figure 4 1 Enter Manage Cassettes View 4 2 VITEK 2 Systems Software User Manual 510773 3ENI Set Up Test Cards and Cassette Information Using the Set Up Tests Post Entry Workflow 2 The Set Up Tests Post Entry view appears Note While processing cards when you log in to the system software the Set Up Tests Post Entry view usually appears displaying a list of cassettes currently loaded in the selected instrument VW setup Tests Post Entry Cassone ietrument Card LoedTme Mar 17 2002 1900 VITEK 2 technology Figure 4 2 Set Up Tests Post Entry View Cassettes appear in the navigation tree When a cassette is selected the following cassette specific information appears in the cassette workspace Dilution Mode automatic pre diluted automatic and pre diluted Cassette ID Instrument Name Load Time and Date Setup Technologist s Name Bench Name
423. tual Cassette Workflow 4 16 Creating a Virtual Cassette 4 16 Viewing Reconciliation Details 4 19 Deleting a Virtual Cassette 4 19 Using the Smart Carrier Station SCS 4 21 Smart Carrier Cassette Information 4 22 Managing Smart Carrier Station Cassettes 4 22 SCS Setup Technologist ID 4 22 ii VITEK 2 Systems Software User Manual 510773 3ENI Table of Contents Bench Name if enabled in general configuration 4 23 Cassette ID iini tila niece ALERTS E INIMA xx 4 25 Setting Up and Entering Quality Control QC Information 4 24 MANAGE PATIENT INFORMATION CLINICAL USE nn 5 1 Viewing and Filtering Patient and Specimen Information 5 2 Adding Patients 5 5 Adding Specimens 5 4 Linking Isolate and Patient Information 5 4 Linking Specimens to an Existing Isolate 5 5 Creating a Specimen Before an Isolate Exists 5 5 Data Management Download 5 6 Deleting Specimens
424. tup Technologist ID 4 22 Shipment Glossary 6 Slashline automatic select organisms for 9 3 Slot bar code for 4 18 defines card in cassette 4 6 4 7 lists card based on location in cassette 4 9 numbers cards in cassette 4 8 when setting up QC test card 4 24 when setting up virtual cassette 4 16 Smart Carrier Station 4 21 Specimen create 5 5 delete 5 6 move 5 6 SRF analysis set time to eject analyzed cards 9 5 background information 6 2 biopattern definition 6 4 in local SRF database 6 4 left unassociated 6 2 copy biopattern to 6 2 database defined 6 5 local database 8 29 supervisor rights 6 2 enable 6 2 10 6 maintain 2 5 SRF Organism create 6 5 6 7 organism definitions 6 2 used by system software 6 2 view 6 4 6 6 SRF Organism Report 6 5 6 16 Standard Symbols use in manual 1 7 1 8 Standard symbols table of symbols 1 10 Start the System Software 2 6 Station Name 4 25 Status Icons and Descriptions Table 8 7 Supervisor approval 8 16 approve QC isolate results 7 9 backup restore utility 14 7 change comments 8 16 configuration settings 2 5 10 5 10 4 confirm changes to isolate group 8 16 create SRF organism 6 7 customize AES expertise component 11 9 inactivity timer 2 10 10 7 locate archived isolate reports 15 10 maintain user accounts 2 8 move isolates to inactive 10 7 open save configuration BCI 12 20 set maximum number of logon attempts 10 8 view archived isolate reports 15 11 BC
425. tus Walarm Messages Instrument Status Current Alarm Alarm History Monthly Instrument Status Instrument Larry 000001637D9F E Month rl Normal Temperature 34 5 C 36 5 C Ranges _ Optics OK Instrument Status Report 2 Printed Jan 8 2004 1652 Instrument Name Lai Normal Temperature Range 34 5 C 36 5 C Optics OK Instrument Name Larry Instrument Serial Number jooo001637 D9F Temperature bes Optical Status Transmittance 1 Status OK Transmittance 2 Status NOT USED Transmittance 3 Status OK Number of Available Slots be Capacity of waste container so Number of cards in waste container lo Serial Ports Used by Instrument Cons Model of Instrument VITEK 2 compact Maximum Number of Cards that can be processing in the selected en Instrument Instrument Firmware Version BAY 0 63 Firmware Spin Board Versions Transport mm Carousel 4 14 S Pagetofi 85x110in Figure 3 5 Current Instrument Status To print Current Instrument Status 4 Click Print to print an instrument report with the information that appears in this window A print window appears 5 Make the appropriate print selections and click OK 6 The Instrument Status report prints to the workstation printer Note If more than one instrument is connected to the workstation select an instrument from the drop down list to print instrument specific
426. ual 510773 3EN1 Getting Started Working in the Software Views Working in the Software Views Much like a Web application you can navigate from one view to the next from any view within the application with the exception of the system administration views Main View From the Main view you can access all of the views that are accessible from the Navigation Bar You can also access views that help you administer the system such as the Configuration and System Utilities views The Main view is a common place for accessing all of the main functional areas within the system software VITEK 2 technology VITEK 2 technology Figure 2 2 Main View Main Navigation Areas of the System Software The main functional areas within the system software include Manage Cassettes Set Up Tests Post Entry VITEK 2 Systems Software User Manual 2 3 510773 3ENI Working in the Software Views 2 4 View and Maintain Isolate Results Manage Patient Information Clinical Use Maintain SRF Data Industrial Use Manage Quality Control QC Configuration System Utilities Getting Started TABLE 2 1 MAIN NAVIGATIONAL AREAS OF THE SYSTEM SOFTWARE View Icon Description Location Manage Cassettes Set Up Tests Post Entry View and Maintain Isolate Results This view allows you to set up tests You can use this view to set up tests by entering information for virtual cassettes
427. uccessfully added the user to the user group The user should now be able to log in to the system Creating AST Card Definitions With each new AST card you need to define a custom AST card to the system software and instrument If the AST card type was not previously defined you need to create the AST card definition To create a new AST card definition 1 From the Main view select Utility View gt Maintain AST Card Definitions 2 The system software displays a list of current AST card definitions sorted by card type 3 To add a new AST card definition to the system select Enter New AST Card Type VITEK 2 Systems Software User Manual 13 5 510773 3EN1 Creating AST Card Definitions System Utilities Figure 13 1 Enter New AST Card Type 4 In the Package Insert Bar Code field enter the bar code from the package insert You can enter it manually or by using the bar code reader 5 After each bar code is entered the system software validates it and displays the new card information 6 The following information appears Bar code line number s Card type Card name User ID Date created e A list of antibiotics on the card Note Ifa card cannot be validated the system software prompts you to re enter or cancel the card definition 7 When you have finished entering the bar codes you will need to confirm that the displayed list of all antibiotics from the bar codes matches the antibiotics listed
428. uct Information CEE dd LL Od al sm ar oe oo eef se oo e om rm so af zeen np feel E Que C e so ww sl DeL 0 om sme oa p mp9 ss re oof mpm NICI INCI NICI pes uf ee s eps vz NI II NTI KIT o on ell ol asaz sales Ce oof oo em co oo co xx s uil pojzeiw w u dor W ef oo oof oa e LL ose al real es o se oof oo e eo oo oo r 3 mm cem os o col 0 ess ex co of o fun ef wre NINI asss IKI fus rs re zo ve ow oi co oe om e a ae aro ee a aw sien es apo eweN uowwo u w 13y Alo aje Wauiaa1fv jenu ssq ISW oAneSoN UI JOJ sonsuojeleu e ueuuojled 1SV 9 neSoN Wes JOJ sorsuopereu D2UPULJOJJOd JUHO ds JEIGOHIUHUV Z AILA T 9 9 qer 6 17 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information Performance Characteristics al siele fef eef ssf af meo wel men om ore oo o sel ve ov oo sss oves un w D Due 008 re ojupbv 3 WiS vo VA upiduejni wuepeqozel rej ool vij sve os oo vif ose 24 o al maps ose ve oo sel sel ce oof oo oss al em upersdid ss soj z os ro co ciel 1 o wo upexoyo es oo vej res si oof vef se 34 e UpeXOIHON su oo oo ex sv oo oo ose al epl nj _wowemonn se Lan Lan ow so m an ve apo wey uowwo u w 13y A1039 e5 u w 18y jenu ssq LSV oAneSoN WeLID JOJ SINSH PLILYJ e ueuuojled 1SV M N Wes 10 SYSH PLILYJ DI
429. uct Information Results 3 Subculture twice to TSAB before running QC SAB or SDA for yeast Note Avoid repeated thawing and refreezing by either freezing in single use aliquots or removing a small portion of frozen organism preparation with a sterile applicator stick Results Susceptibility Analytical Techniques The system evaluates each organism growth pattern in the presence of the antimicrobial in relation to the growth in the control well Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations Discriminant analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials or antifungals on VITEK 2 systems The MIC result must be linked to an organism identification in order to determine a category interpretation Accurate identification is critical especially with certain organism antibiotic combinations e g Staphylococcus aureus oxacillin In cases where the identification of an organism is in question confirmatory testing is necessary in order to assure correct interpretation of susceptibility results A category interpretation will be reported along with an MIC according to the interpretations defined by CLSI or Comit de l Antibiogramme de la Soci t Francaise de Microbiologie CA SFM or to an adaptation of the global settings according to other local guidelines Combination Antibiotics The MIC
430. ulatory agencies Table 2 5 QC Organism Enterococcus casseliflavus ATCC 700327 AMY CDEX BGURr URE dMAL E PUL PIPLC AspA AGAL POLYB v BACI ar dRAF dXYL BGAR PyrA dGAL NOVO ar 0129R v ADHI v AMAN v BGUR dRIB NC6 5 SAL BGAL PHOS AlaA v ILATk dMAN SAC AGLU v LeuA v TyrA v LAC dMNE dTRE APPA v ProA dSOR v NAG MBdG ADH2s v OPTO 95 to 100 positive v 6 to 94 positive 0 to 5 positive Occasional negative reaction may occur with faster identification result VITEK 2 Systems Product Information 28 069042 5EN1 GP Quality Control Table GP Product Information Table 2 6 QC Organism Kocuria kristinae ATCC BAA 752 amy CDEX BGURr ue dMAL v PUL PIPLC AspA AGAL POLYB v BACI v dRAF dXYL BGAR PyrA v dGAL NOVO OI29R v ADHI v AMAN BGUR dRIB NC6 5 SAL V BGAL PHOS AlaA ILATk V dMAN SAC AGLU LeuA TyrA v LAC dMNE dTRE V APPA v ProA dSOR v NAG MBdG ADH2s OPTO 95 to 100 positive v 6 to 94 positive 0 to 5 positive Table 2 7 QC Organism Listeria monocytogenes ATCC BAA 751 AMY CDEX BGURr URE dMAL t PUL PIPLC v AspA v AGAL POLYB BACI dRAF dXYL BGAR PyrA dGAL NOVO v 0129R ADH1 AMAN BGUR dRIB NC6 5 SAL BGAL PHOS AlaA v ILATk d
431. ults to aid in the direction of therapy For some antimicrobials e g high level gentamicin high level streptomycin only a qualitative result is generated The standard and reference procedures are based on susceptibility tests requiring 16 to 24 hours of incubation Various manufacturers have now developed automated procedures designed to generate results more rapidly by using shortened incubation times Laboratories worldwide use either variations of the standard reference procedure or a commercially available product to determine the MICs of infectious organisms Extended Spectrum Beta Lactamases ESBLs ESBLs are enzymes that arise by mutations in genes for common plasmid mediated beta lactamases Strains of Klebsiella spp and E coli that produce ESBLs may be clinically VITEK 2 Systems Product Information 6 1 510774 3EN1 Summary and Explanation of the Test Susceptibility Product Information resistant to therapy with penicillins cephalosporins or aztreonam despite apparent in vitro susceptibility to some of these agents Some of these strains will show MICs above the normal susceptible population but below the standard breakpoints for certain extended spectrum cephalosporins or aztreonam Before reporting a strain as an ESBL producer a confirmatory method should be performed Please refer to the current Clinical and Laboratory Standards Institute CLSI guidance document for CLSI recommendations According to the CLSI f
432. up 14 5 isolate information cleanup 14 4 patient information cleanup 14 4 QC Isolates flagged as aged 14 4 Index 4 VITEK 2 Systems Software User Manual 510773 3ENI Index Exceed Inactivity Timer Limit 2 10 Expected Organism 4 25 Expected Therapeutic Response customize select one or more antibiotics 11 20 Export Isolate and Raw Instrument Data 8 9 Export Result Reports to Electronic Media 8 29 13 16 External Data Management System isolate sent to 8 35 LIS 5 5 map codes to 12 30 F Filtering Cassettes 4 4 Find Topics in manual 1 4 online 1 5 G General Configuration access 10 5 bench area 10 9 customize inactivity timer 10 7 enable SRF 6 2 9 2 print settings global enabled in 10 8 select industry mode 10 6 set maximum number of logon attempts 10 8 settings 10 4 system information 10 6 view limited patient demographics 10 9 H Hour of Call 9 3 9 4 ID alternative unique patient ID 5 3 unique patient ID 5 3 ID Card analysis problems 9 6 link to one or more AST cards 4 10 view card details 7 7 view detailed biochemical results 8 17 ID Card Details Report 8 35 ID Card Ejection Time set hour of call 9 3 set max card incubation 9 3 ID Configuration change slashline organism group 9 3 enable SRF analysis 9 3 10 6 industry mode 9 2 modify identification settings 9 2 select organisms for automatic slashline 9 3 set ID card ejection time 9 3 Identification Testing information about 1
433. upon addition of a PAL ALKALINE PHOSPHATASE specific reagent Pyrro Ary Pyrrolydonyl ARYLAMIDASE Adherence Adherence to agar Sticking of colonies to Characteristic of 21 the agar surface Rothia mucilaginosa AER GROWTH AEROBIC GROWTH Growth in air 18 2 18 VITEK 2 Systems Product Information GP Product Information 069042 5EN1 GP Product Information Abbreviation Table 2 14 Test Name GP Supplemental Tests Description GP Supplemental Tests Comments Reference Arg hydr ARGININE dihydrolase Hydrolysis of arginine releases an amine resulting in alkalinization of the medium observed with a pH indicator e g purple color formation in the presence of bromocresol purple 2 1718 21 B HEM BETA HEMOYSIS Certain species possess hemolysins that give a transparent zone around colonies on blood based agars 1718 21 27 BILE ESC BILE ESCULIN Bile esculin positive organisms are able to grow in the presence of 40 bile and to hydrolyze esculin 15 20 BILE SOL BILE SOLUBILITY Pneumococcal colonies completely lyse and disappear when exposed to a 1096 solution of deoxycholate Rapid test for Streptococcus pneumoniae 21 CAMP S au CAMP TEST Staph aureus Synergistic hemolysis of Listeria moncytogenes colonies by beta toxin producing colonies of Staphylococcus aureus 21 CAT CATALASE Colony p
434. uration see Link Configuration on page 12 14 Tools see Tools on page 12 20 Ecij Supervision COM Manager 4 Supervision e Transaction Log Link Operations e LISI TheraTrac o Unused Link Name Status Upload Download Host Configuration e Unused LIS1 21 Link Configuration TheraTrac e LISI Unused TheraTrac Unused Unused Unused z Tools STARTED STARTED STOPPED STOPPED ENABLED ENABLED DISABLED DISABLED ENABLED DISABLED DISABLED DISABLED BACK IN SERVICE BACK IN SERVICE BACK IN SERVICE BACK IN SERVICE bioM rieux Literal COM4 961 COM 1 0 900 8273 bioM rieux Literal COM1 481 bioM rieux Literal COM 481 us1 TheraTrac svo Unused 600 Unused 600 Figure 12 2 BCI Status VITEK 2 Systems Software User Manual 510773 3EN1 12 3 Configure and Maintain BCI Supervision Supervision Supervision is the first link in the Navigation tree it allows you to see a global status on each link ki Supervision COM Manager Supervision e Transaction Log 1 Link Operations v LISI TheraTrac Unused Link Name Status Upload Download Host Configuration Unused ust STARTED ENABLED ENABLED BACK IN SERVICE bioM rieux Literal COM4 961 Link Configuration TheraTrac STARTED ENABLED DISABLED BACK IN SERVICE COM3 1 0 900 8273 e LIS1 Unused STOPPED DISABLED DISABLED BACK IN SERVICE bioM
435. urrent Alarms Alarm History LIIS E nx VITEK 2 technology VITEK 2 technology Figure 3 1 Instrument Status Icon 3 2 VITEK 2 Systems Software User Manual 510773 3EN1 Instrument And System Status Instrument Alarm Status Icons Instrument Alarm Status Icons OK The icon with the green square means the connection with the VITEK 2 instrument is okay Click this icon to see the instrument status Figure 3 2 Instrument OK Status Warning The icon with the orange triangle indicates a problem with the instrument Click this icon to see a description of the warning Figure 3 3 Instrument Warning Status Error The icon with the red circle indicates an error in the instrument Click this icon to see a description of the error condition Figure 3 4 Instrument Error Status View and Print Current Instrument Status You can see instrument parameters by checking the instrument status To view Current Instrument Status 1 Click the Instrument Status icon at the bottom of the screen 2 Select the Current Instrument Status tab to view the details of the instrument status 3 The Alarm Messages Instrument Status window appears Note f more than one instrument is connected to the workstation select an instrument from the drop down list to view instrument specific status information VITEK 2 Systems Software User Manual 3 3 510773 3EN1 View Instrument Monthly Status Instrument And System Sta
436. versal precautions K A All patient specimens and microbial cultures are potentially M 6 10 Storage and Handling Upon receipt store VITEK 2 AST cards unopened in their original package liner at 2 C to 8 C Instrument The VITEK 2 instruments are a family of in vitro diagnostic devices intended to rapidly assess the antimicrobial susceptibility of bacterial pathogens to available antimicrobial agents For complete information on use and operation of the instrument see the instrument user manual Specimen Preparation For information on Specimen Preparation see the following Culture Requirements Table VITEK 2 Systems Product Information 6 5 510774 3EN1 Culture Requirements Table Susceptibility Product Information Culture Requirements Table Table 6 1 Culture Requirements Table Age of VITEK 2 Media Age of Incubation Inoculum Dilution eee Card Culture Conditions Density for AST Loading Instrument AST TSAB 81024 35 Cto 37 C 0 50 to 0 63 145uLin lt zo minutes Gram CBA hours Aerobic non CO McFarland 3 0mL Negative mac Standard saline AST TSAB 18 to 24 35 C to 37 C 0 50 to 0 63 280uLin lt zo minutes Gram CBA hours 5 to 10 or McFarland 3 0 mL Positive Aerobic non CO Standard saline SDA 18t096 35 C to37 C 1 80 to 2 20 280pLin lt zo minutes SDA hours Aerobic non CO Mcfarland 3 0 mL Alb ID2 Standard sa
437. view Deduction by Phenotype Enable Deduction by Phenotype For deduction based on phenotypes AES uses the MIC distributions and the therapeutic interpretations for the phenotypes recognized Phenotype recognition is the second method for antibiotic deduction For recognized phenotypes during the AES analysis antibiotics that were not tested and that span only one interpretation category are reported as deduced If the MIC distribution spans more than one category but a therapeutic change should be performed based on the phenotype the deduced results are reported When more than one phenotype is a possibility the most resistant possibility is reported Equivalent Deductions VITEK 2 Systems Software User Manual 11 7 510773 3EN1 Enable Deduction by Equivalent Antibiotic For deduction based on equivalent antibiotics AES activates the antibiotic deduction rules corresponding to the active interpretation guideline For details see Appendix C AES Antibiotic Deduction Rules by Therapeutic Interpretation Guideline For the equivalent deduction method the observed interpretation of the tested antibiotic is reported as the interpreted result for the requested deduced antibiotic The rules governing the strict deduction of antibiotics are contained in the interpretation guidelines and are based on national committee recommendations Activating a Parameter Set Settings Note View and Configure AES Maximum MIC Correct
438. vigation 2 2 2 5 purpose 1 2 record new card shipment 7 12 restore isolate data from backup CD 14 7 SRF database 6 3 8 29 start the application 2 6 system analysis and interpretation guidelines for 11 8 system software alarms 3 6 updates laboratory identification number 8 12 organism quantity 8 16 T organism short name 8 13 uses activated SRF organism 6 2 view limited patient demographics 10 9 view reconciliation details 4 19 views 2 3 System Utilities archive and view archived isolate reports 2 5 back up archive restore data to the system 2 5 create new AST card definitions 2 5 search audit history 2 5 setting up user accounts 13 2 views 2 5 Table of symbols 1 10 Test Cards processing 4 9 Test Results change information associated with 8 11 organism short name 8 12 organized by isolate groups 8 3 view details for final identification test 8 17 Test Setup Information automated input 4 7 Testing Date QC cumulative report sorts by 7 18 Tests using new AST card 13 6 Therapeutic Interpretation Guideline change guideline name 11 19 create new guideline 11 19 Therapeutic Response add 11 20 customize 11 19 delete 11 21 Tools open configuration 12 20 print configuration 12 20 save configuration 12 20 Topics find in manual 1 4 find online 1 5 Transaction Log delete messages 12 8 isolates uploaded 12 7 VITEK 2 Systems Software User Manual 510773 3EN1 Index 11 Index print uploaded messages 12 9 s
439. vigation tree Table 8 1 Status Icons and Descriptions Icon Description E Preliminary Isolate is still receiving raw data readings from the instrument isolate is not final Final Qualified Isolate final with missing information m Examples of missing information include lt lt low discrimination gt gt lt lt slashline gt gt Beta lactamase when configured for CLSI Patient information Missing Organism Isolate Complete Sent to Lab Information System LIS L Isolate final Isolate is not qualified Isolate does not need review Isolate does not need approval If enabled isolate sent to LIS Isolate is a candidate to be removed from the active workspace icon Based on user configuration of Results Validation All isolates To be Reviewed Isolate final and needs to be reviewed click the Review v Critical isolates only To be Approved Isolate is final and needs to be approved click the Approve icon Based on user configuration of Results Validation All isolates Critical isolates only 8 8 VITEK 2 Systems Software User Manual 510773 3ENI View and Maintain Isolate Results Using the Right View Bar to View Specific Results Qualified Isolates After the system software has analyzed the test card readings isolates with the following characteristics will be flagged as qualified Table 8 2 Qualified Isolates Type Descript
440. with pherctypes ores ranas Artic fomes WALD CEFHALOSPORINASE HGH LEVEL PETAL ACTAMASE CEPHALOSPCANASE AST GNDA Ping Oct 9 200 v 207 1 Ert aerogenet ASTMA Fir Oct 8 200 Figure 8 16 AES Graphic Selecting and Moving a Test From the View and Maintain Isolate Results view you can navigate among isolate results to view and maintain isolate information and move test cards between isolate groups By default the navigation tree is collapsed to the isolate group level and the view is set to Isolate For details see Expanding and Collapsing the Navigation Tree on page 8 6 Note You can only move test cards between isolate groups that share the same laboratory identification number isolate number organism quantity offline test and results and bench The new isolate group must not contain duplicate antibiotics You cannot move a card between isolates if either isolate group has already been reviewed or approved 1 From the View and Maintain Isolate Results view expand the isolate group to view the test cards within that isolate group 2 Select a test card within an isolate group 3 The test card information appears in the active workspace VITEK 2 Systems Software User Manual 8 27 510773 3EN1 Viewing Card Details Note Note View and Maintain Isolate Results 4 Tomove the card to another isolate group select the card and drag and drop the card into another isolate group All cards in an
441. x caract res permettant de diff rencier les esp ces du genre Listeria D apr s BILLE J ROCOURT J 15 Facklam RR What Happened to the Streptococci Overview of Taxonomic and Nomenclature Changes Clin Microbiol Rev 2002 15 613 630 16 Farrow JAE Facklam RR Collins MD Nucleic acid homologies of some vancomycin resistant leuconostocs and description of Leuconostoc citreum sp nov and Leuconostoc pseudomesenteroides sp nov Int J Syst Bacteriol 1989 39 279 283 17 Freney J Renaud F Hansen W Bollet C Pr cis de bact riologie clinique ESKA Paris France 2000 18 Holt JG Krieg NR Sneath PHA Staley JT Williams ST editors Bergey s Manual of Determinative Bacteriology 9 edition Williams and Wilkins Baltimore Maryland 1994 19 Kilpper B lz R Schleifer KH Streptococcus suis sp nov nom rev Int J Syst Bacteriol 1987 37 160 162 20 Koneman EW Allen SD Janda WM Schreckenberger PC Winn WC Jr Color Atlas and Textbook of Diagnostic Microbiology 5 edition Lippincott Raven Philadelphia PA 1997 21 Murray PR Baron EJ Pfaller MA Tenover FC Yolken RH editors Manual Of Clinical Microbiology 7 edition American Society for Microbiology Washington D C 1999 22 Murray PR Baron EJ Jorgensen JH Pfaller MA Yolken RH editors Manual Of Clinical Microbiology Volume 1 8 edition American Society for Microbiology Washington D C 2003 23 National Committee for
442. y Report 3 7 Alarms acknowledge all alarm messages 5 6 system software alarms 5 6 view unacknowledged alarms 5 6 Antibiotics bar code list matches package insert list 15 6 deduced highlighted on report 8 51 name of antibiotic on AST card 8 19 on reports 8 19 suppressed not printed on chart report 8 51 tested and deduced 8 18 Antibiotics to Deduce configure AST analysis 9 5 select 9 4 Antibiotics to Suppress organism antibiotic combination 8 20 9 5 select 9 5 when configuring AST card analysis 9 5 Antimicrobial Susceptibility Testing See AST Application Views configuration 2 5 AES 11 4 AST 9 5 BCI 12 25 general configuration 9 2 VITEK 2 Systems Software User Manual 510773 3EN1 Index 1 Index ID 9 3 result validation 9 6 software version installed 10 10 main view 2 3 maintain SRF data 2 5 manage cassettes set up tests 2 4 manage patient information 2 4 quality control 2 5 system utilities archive and view archived isolate reports 2 5 create new AST card definitions 2 5 search audit history 2 5 view and maintain isolate results 2 4 Approve QC Isolate Results 7 9 Approve Results 7 9 Archive archive isolate reports to CD 13 10 CD reference number 13 10 isolate reports 13 10 isolates eligible for 13 9 search audit trail from 13 15 tests deleted from active workspace 13 9 Associate SRF Organism to an Unassociated Biopattern 6 5 Associate Test Cards 4 9 AST Analysis background information 1 2
443. ylococcus auricularis Staphylococcus capitis Staphylococcus chromogenes Staphylococcus cohnii Staphylococcus cohnii ssp cohnii Staphylococcus cohnii ssp urealyticus formerly Staphylococcus cohnii ssp urealyticum Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus hominis ssp hominis Staphylococcus hyicus Staphylococcus intermedius Staphylococcus kloosii Staphylococcus lentus Staphylococcus lugdunensis Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus warneri Staphylococcus xylosus Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pneumoniae ATCC 49619 Yeast Organisms Claimed for AST YS Keyid Candida albicans Candida dubliniensis Candida glabrata Candida guilliermondii Candida haemulonii Candida inconspicua Candida intermedia Candida kefyr Candida krusei Candida krusei ATCC 6258 Candida lipolytica Candida lusitaniae Candida norvegenis Candida parapsilosis Candida parapsilosis ATCC 22019 6 56 VITEK 2 Systems Product Information 510774 3ENI Susceptibility Product Information List of Claims Candida pelliculosa Candida rugosa Candida tropicalis Candida utilis Cryptococcus neoformans Stephanoascus ciferrii VITEK 2 Systems Product Information 6 37 510774 3EN1 Bibliography Susceptibility Product Information Bibliography 1 MacLowry J D and H H Marsh 1968 Semi automa
444. you may want to require your personnel to log in and out of both the application and Windows XP using their own account Creating User Accounts VITEK 2 Systems Software User Manual 510773 3EN1 To create user accounts log in to Windows XP as an Administrator membership you will need to log out Note If you are already logged into an account without administrators Create and Maintain User and Security Settings System Utilities 1 2 3 4 5 Example User Name LabAdmin Password labadmin Right click on the Computer icon located in the upper left corner of the desktop and select Manage to open the Computer Management window Under System Tools expand Local Users and Groups Right click on Users and choose New User The New User window appears Enter the User Name For example LabTech1 Enter the Full Name as you want the user s name to appear within the VITEK 2 Systems software Note bioM rieux recommends that you enter last name first name 6 7 8 9 Enter an optional description Enter the user s password By default the password must contain a minimum of six alphanumeric characters Enter the password again to confirm your password Select the password options that best meet your laboratory s needs Note f you do not select Password never expires the user must periodically log in to Windows XP and update their password The VITEK 2 Systems software will
445. your local inspecting agency s guidelines for disposal of hazardous waste Identification Analytical Techniques The identification of an organism using the VITEK 2 Systems uses a methodology based on the characteristics of the data and knowledge about the organism and reactions being analyzed Sufficient data have been collected from known strains to estimate the typical reactions of the claimed species to a set of discriminating biochemicals If a unique identification pattern is not recognized a list of possible organisms is given or the strain is determined to be outside the scope of the database The printed lab report contains suggestions for any supplemental tests necessary to complete the identification If the tests are not sufficient to complete the identification then standard microbiology references and literature should be consulted Certain species may belong to a slashline mixed taxa identification This occurs when the biopattern is the same for the taxa listed Supplemental tests may be used to separate slashline taxa The following species belong to NH slashline taxa Table 4 1 NH Slashline Taxa Slashline Name Species Belonging to the Slashline Haemophilus Haemophilus aphrophilus aphrophilus paraphrophilus Haemophilus paraphrophilus 4 4 VITEK 2 Systems Product Information 532511 4EN1 NH Product Information Percent Probability Identification Card Qualifying Messages Table 4 2 Ident
446. ystems Software User Manual 510773 3EN1 Maintain Customer Quality Control Reviewing QC Results Reviewing QC Results Based on your laboratory policy you may need to review current QC results for both ID and AST cards and mark them as Reviewed Depending on the results configuration you may need to review and or approve QC Results and apply your electronic signature if electronic signature is enabled to mark them Reviewed Note Depending on your review validation configuration multiple reviews and approvals may be permitted without the user making any changes to the isolate information QC results waiting to be reviewed are preceded by the To be Reviewed icon To review QC results isolate group analysis must be complete To review QC Results 1 Select a QC Isolate group preceded by the To be Reviewed icon 2 Click the Review Results icon Figure 7 4 Review Results Icon 3 Depending on your results validation configuration the following may occur If system software is configured based on the default setting Review Critical Isolates The system software flags the QC isolate as Reviewed The QC Isolate icon changes to green The system software transfers the QC isolate into the QC cumulative workspace for long term storage If system software is configured for Review and Approve The system software flags the isolate as To Be Approved The QC Isolate icon changes to the To Be Approved icon 4 If an E

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