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VITEK 2 User`s Manual 510731-4

1. 5 3 What are the Configuration Options 5 3 When Should Configuration Options be Set 5 4 How Configuration Options Affect VTTEK 2 5 5 Cassette Names u saa sa sasaqa ta V NOCTES 5 5 Instrument Name 5 7 Schedule Instrument QC Status 5 8 Cassette Mode u ee Rec ne Pare cee id 5 10 Dilution Mode 5 11 Bar Code Reader EE 5 12 Audible Alarm Enable 5 13 Audible Alarm Volume 5 14 Visual Alarm Enable 5 15 Keyclick Volume 5 16 Screen Contest eios suy ened ed eH 5 17 How to Set VITEK 2 Configuration Options 5 18 Where to Find the Configuration Options 5 19 How to Define Character Sets 5 20 How to Set Time for the QC Status 5 22 How to Use Option Boxes 5 24 How to Seta Range Value 5 25 The VITEK 2 User s Manual ix Table of Contents 6 Processing VITEK 2 Test Cards Introduction idiota KE STEEN RIA LESS 6 1 Where to Pind dto Se ee Dua 6 1 About the VITEK 2 Status Screen 6 3 About the VITEK 2 Menu System 6 10 About the Smart Carrier Station 6 13 Advantages of Using the Smart Carrier Station 6 13 6 16 U
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4. preg sondo UAOQ mys 5011 onodig ucuo eui e S nuon sonsouserq Gu ummnsul oou uojure A wog 9AOJA SIOJId IPOD nu yy peo T dnjog snes 20 Ieg 9A osos sonny anossey juoumujsug Aeids q nuoJA URW C MHLIA 6 11 The VITEK 2 User s Manual Introduction Processing VITEK 2 Test Cards This manual describes the pathway to a specific function by naming each menu to access with the menus separated by arrows For example the pathway to the Change Saline func tion on the Maintenance menu would be shown as follows Main Menu gt Utilities gt Maintenance KEYS You USE MOST OFTEN There are several keys on the keypad that are used often when using the VITEK 2 menu system Option Buttons There are five round buttons located along the right side of the user interface screen When a menu or function option appears on the screen you press the corre sponding option button to access that menu or function Previous Screen Key This key has three actions depend ing on what displays on the screen Figure 6 5 The Previous Screen Key Ifa function displays on the screen pressing the PRE VIOUS SCREEN key returns the display to the menu from which the function was selected 6 12 The VITEK 2 User s Manual Processing VITEK 2 Test Cards About the Smart Carrier Station If a menu displays on the screen pressing the PRE
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6. Figure 8 2 Instrument Halted Status Screen Reader This field indicates whether the Reader station is still processing or has been halted due to the error Card Transport This field indicates whether the card transport system is still processing or has been halted due to the error Minutes This field indicates how many minutes the error condition has existed Messages Pending This field indicates how many mes sages are currently in the error message queue NOTE You can access the error message queue by pressing the Error Message key Go Press the Go option button to resume processing after you have corrected the problem 12 00 Time error occurred 8 8 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument The Error Handling System STATUS SCREEN WITH A STATUS OF MESSAGES This status indicates that there is an error message in the error message queue that has not been viewed Notice that the Status field 69 has changed to Messages indicating that there are error messages in the error message queue 12 00 Status Messages MAX Available Slots 60 Cassette Name NSB Dilution Mode Automatic Tips Saline Figure 8 3 The VITEK 2 Status Screen The VITEK 2 User s Manual 8 9 The Error Handling System Troubleshooting the VITEK 2 Instrument Press the Error Message key to view the error message queue If there is more than one message
7. 3 Open the front access door see figure at right A boat will be positioned below the Dispenser Pipettor station NOTE A boat may be positioned at the Cassette Load Station but it must NOT be removed from that position 4 Remove the boat from below the Dispenser Pipettor station and press the Press here after completion option button see step 2 on page 7 40 The first screen reappears with the boat count at 3 of 4 5 Repeat this procedure starting at step 2 until all 4 boats have been removed 6 Press the Previous Screen key The VITEK 2 User s Manual 7 41 Cleaning the Boats Maintaining the VITEK 2 Instrument How to Clean the Boats The four boats should be thoroughly cleaned and dried before they are replaced in the VITEK 2 instrument The boat material is designed to withstand any of the following cleaning methods Automatic dishwasher with standard laboratory detergent CAUTION Dishwasher temperatures during the washing and drying cycles must not exceed 85 C 185 F Exceeding this tem N perature will cause damage to the boats Use the top rack of the dishwasher e 1096 bleach solution Phenolic cleaning solution NOTE To disinfect a contaminated surface use the 10 bleach solution and allow it to remain in contact with the contaminated surface for five minutes How to Replace Boats after Cleaning NOTE If you are performing monthly maintenance on th
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10. NOTE This screen does not appear for the Instrument Name option 2 Press a number key to select one of the ten cas sette name positions and then press ENTER 5 20 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How to Set VITEK 2 Configuration Options The character selection screen appears Cassette Names JKLM abcdefghijklm nopqrstuvvxyz NOTE This screen is similar for both the Cassette Names and Instrument Name options Select a letter using the ARROW keys and then press the option button for the character box If you make a mistake press the backspace option button 3 The VITEK 2 User s Manual 5 21 How to Set VITEK 2 Configuration Options Configuring the VITEK 2 Instrument How to Set Time for the QC Status The function allows you to set up to three times during the day at which an instrument QC report is sent to the workstation Access the Schedule QC Status function using the path Main Menu gt Utilities gt Configuration The following screen appears Schedule QC Status e Time A gt 04 01 Time B DISABLED Time C DISABLED Hours Minutes e Disable Next 4 The time fields operate on a 24 hour clock Times A B or C are disabled until you schedule the QC Status NOTE The LEFT or RIGHT ARROW keys beneath Hours Minutes allow you to toggle between Hours and Mi
11. ees sondo au uo 1891 sonsouBeip uuopoeg Z 89S sondo ou up r elo pue ejejduioo Spied Joy L SH uoneJqi eo suryovoidde st u s sonu 2 1 euin popuour V L 4 uo emp ul0291 OY 1005 820Jd S Wy A4OSS V e su ou p l ds y uey Jo3uo osn SuIUIeA uey Je8uo jueuunjjsui y ui ueeq e eu sd n did out uruseqoaeusdrpy Surssooodd 93po Ipod 1011 Sunpssoag AADI ABUL a qu 4940224 PUD ASVSSaP 40445 c g QPL The VITEK 2 User s Manual 8 76 Appendix Hardware Specifications VITEK 2 Instrument Dimensions Dimension VITEK 2 VITEK 2 XL Height 67 cm 26 3 in 67 cm 26 3 in Width 100 cm 39 4 in 140 cm 55 1 in Depth 71 cm 27 7 in 71 cm 27 7 in Mass VITEK 2 VITEK 2 XL Mass Approximately 110 Approximately 145 kg 240 Ib kg 320 Ib CAUTION The VITEK 2 instrument is heavy Use at least two people to move it Lift handles are provided at each end of the instru K ment The VITEK 2 User s Manual Appendix 1 Appendix Hardware Specifications Environment Appendix 2 NOTE The specifications below apply to both the VITEK 2 and the VITEK 2 XL Indoor usage Do not install in direct sunlight Benchtop should be level within 2 Minimum of 5 cm 2 in clearance on all sides for adequate ven tilation 50 cm 20
12. The Status Screen in an Error Condition 8 7 Reviewing an Instrument Halted Screen 8 12 Reviewing a Status Screen with Messages 8 13 Reviewing a Status Screen with Errors 8 14 The VITEK 2 User s Manual 8 1 Introduction Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors 8 15 Why Do They Occur 8 16 Work Flow Considerations 8 17 Bar Code Read Failure 8 17 SCS and Bar Code Reader Conflict 8 21 Inoculum Errors 8 24 Card Capacity Errors 8 26 Disposables Errors 8 29 Working Without the VITEK 2 Bar Code Reader 8 30 Howto Enter Bar Codes Manually 8 31 Instrument Diagnostics 8 33 Instrument Diagnostics Menu 8 33 Diagnostic Tests 8 34 Cleaning and Verifying the Optics with Cards Processing 8 43 Optical Diagnostic Test 8 48 Boat Transport Positions 8 50 Power Failures 8 52 Displaying Version Information 8 54 How to Use the Error Message and Recovery Table 8 55 How to Restart the Instrument 8 56 8 2 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument The Error Handling System The Error Handling System The VITEK 2 instrument continually monitors itself to ensure that it is operating within specifications To do this it uses numerous optical mechanical and temperature sensors located within each subsystem If a sensor detects a problem the VITEK 2 instrument is programmed to alert you to the situa tion and
13. Security The SCS provides an extra measure of security for your test card specimen information After a cassette is placed in VITEK 2 a bar code reader in the instrument reads the bar code on the test card and compares that infor mation with the information it read from the cassette Any discrepancies in test card type or position in the cassette are reported to the user so that corrective action can be taken The VITEK 2 User s Manual 6 15 About the Smart Carrier Station Processing VITEK 2 Test Cards Data Fields There is one data entry screen with six fields The fields are repeated for each of the available 15 slots in the cassette Station name is TRB Slot 6 Accession ID Iso l 1234_ l Card Type AST P515 Organism ID Staaur o Ancillary Tests e Modifier Modi Dilution mode Automatic 6 l 51 1454 x s4 e 00000 Figure 6 6 Fields of the Data Entry Screen Field Description Accession ID This field identifies the specimen It can contain up to 20 alphanumeric characters This is a required field meaning it must be filled before other fields can be entered O Isolate This field defaults to a value of 1 and is Number normally skipped during data entry To replace the default move the cursor to this field using the UP arrow key Test Card This f
14. Figure 8 9 Boat Transport Positions 8 50 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Boat Transport Positions ee NOTE Cassette Load Unload station NOTE Boats must not be removed or replaced at this station This is the area you see when you open the front access door Button Memory Station Pipettor Station Boats must only be removed and replaced from between stations and When a boat is replaced center it on the opening between the two guide rails see arrow in the picture Vacuum Station Cut Seal Station Card Load Unload Station Always remove and replace boats using the proce dures on page 7 39 and page 7 42 respectively CAUTION See Laser Caution statement on page xviii A The VITEK 2 User s Manual 8 51 Power Failures Troubleshooting the VITEK 2 Instrument Power Failures What happens in the VITEK 2 instrument if there is a power failure The instrument is supported by a device called an Unin terruptible Power Supply UPS If power is lost the UPS uses a battery to continue to supply power to the instrument The UPS notifies VITEK 2 of a power failure The following events then take place in which the instrument Initiates a Power Failure error message Begins a 20 minute timer Continues processing test cards in the carousel Continues to support the card transport system but does NOT allow new cassettes to be loaded 8 52
15. Glossary Incubator The incubator contains a heater and a circulating fan used to incubate the cards during test The temperature is monitored and controlled through the use of two remote precision ther mistors monitored by a microprocessor holding the card at an average temperature of 35 5 C Instrument Bar code reader This station reads the bar code label on each VITEK 2 test card within the first minute after the test cards are read and transfers all of the test card bar code data to the VITEK 2 Workstation computer Job Aid Card A laminated card containing frequently used functions that can be used as a quick reference tool There is one Job Aid Card for the Smart Carrier Station and another for the VITEK 2 Instru ment LED Light emitting diode a light emitting device used in optical dis plays and such consumer products as microwave ovens and digital clocks Also see transmittance optics The VITEK 2 User s Manual Glossary 7 Glossary Pre diluted Mode One of two possible settings for the Dilution Mode configura tion on the VITEK 2 instrument In Pre diluted mode the user prepares AST suspensions prior to loading test cards on the instrument See Automatic Dilution Mode Saline Dispenser Tube A fixed volume chamber used to measure and dispense 2 5 ml of saline into a susceptibility tube Sample preparation stations This multi function VITEK 2 system consists of several sta tions Bar Code Reader Button
16. HOIH 2 1ne3od UI L Iojeqnoug AO JO eqnoutr y 1eesoJ JO eoej dai pue 100p ssoooe juBu doj v uedo Ho SI 1 AO 8 9 2 eBed uo eunpeooud ees Heq ulles y e ejdeu MOT OAOT UT E euin popuour 9 2 eDed ul0201 V 1005 uo eunpoeoouJd s Heq ulles eui eo ejdeu oun payloads uey 1o2uo sn Zum eu uey JeBuo lu uunu su v u seu 85 oul U Uq SLY MES SurssoooJdq 9po 9p0O 1011 NPI MOANA a qu 4940224 PUD ASVSSaP 40445 c g QPL 8 73 The VITEK 2 User s Manual e qe Ie A SjO S Jo Joquinu 102121 5 E IALY NOA ains IY SSLI p Surpeof 1oJ q UAIS snjejg 201 JOO p nous noA ALON 9c g o6ed uo sj0413 Ajroede pipo J0 seunpeooud o s l ki ojosseo sty ssoooJd o SJO S JUSTIOLJJNSUT eouel SISSe JO xn l NOIqQ 22 ewou o Deng jou seu euni eJeduiej queuunujsul eui J 9euoai pue sejnuiu S EAA 006 AO Q 51 WOO juerquie eu yey euynsu3 HDIH SI juour nijsu TEUT TU e Dauodat aq 1 4 10119 Y o Jord poezi eurg 219A yey sonoiqnue Aur spied SV _ SISATEUE our uoneqnour juerorgnsug Lv NIIN JAL IVO e8essour ou qr pojund TTTA yodat KIOjEIOQqV V SIn220 1O119 STY pojeururo oq IIA osno y ur Surssoooud ns
17. V J TEK ef WO VITEK 2 User s Manual 510731 4 d BIOMERIEUX bioM rieux Inc bioM rieux sa Box 15969 69280 Marcy l Etoile e France Durham North Carolina 27704 0969 USA tel 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 tel 1 800 682 2666 http www biomerieux com Argentina bioM rieux Argentina SA Av Congreso 1745 C1428BUE Capital Federal Buenos Aires tel 54 11 5555 6800 fax b4 11 5555 6888 Australia bioM rieux Australia Pty Ltd Unit 25 Parkview Business Centre 1 Maitland Place Baulkham Hills NSW 2153 tel 61 2 9899 4700 fax 61 2 9899 1232 Austria bioM rieux Austria GmbH Eduard Kittenberger Gasse 97 A 1230 Wien tel 43 1 86 50 650 fax 43 1 86 50 661 Belgium bioM rieux Benelux s a n v rue Victor Hugostraat 215 1030 Brux elles Brussel tel 32 2 743 01 70 fax 32 2 733 55 97 Brazil biolab M rieux S A Estrada Mapu 491 Jacarepagu CEP 22710 261 Rio de Janeiro R J tel 55 21 2444 1400 fax 55 21 2455 6099 Canada bioM rieux Canada Inc 4535 Dobrin St Laurent Qu bec H4R 2L8 tel 1 514 336 7321 fax 1 514 336 6450 Chile bioM rieux Chile SA Seminario 131 Providencia Santiago 6841416 tel 56 2 634 2092 fax 56 2 634 2093 China bioM rieux China Limited Unit 1701 2 17 F Nanyang Plaza No 57 Hung To Road Kwun Tong Kowloon Hong Kong tel 852 2356 7033 fax 852 2330 2085 Colombia bioM rieux Colomb
18. zx 2 V SWJS s do xx q V dum osnoue 31 4oy 1od qI snjejg O 1uoumagjsug 499 x ueg duq DEA s JaquivyD umnoeA DEZ ees umnoeA DEZ uvg oseq 8891 gy V Kei JSEAA WAI X v s ndo ue sayjosse_ DEZ Sg V psnoae Ue sjeog 4891 WV SdLL n diq 9508 wv ures 33u q 67 SC LZ 97 SZ HZ EZ TZ TZ OC 61 ST LT uuopy Jo 4eq Je9A 4 UOWN 07 99UEUS UIEIN 1X c MALIA 8 Troubleshooting the VITEK 2 Instrument Introduction This chapter helps you to resolve any problems that may occur while operating the VITEK 2 instrument The first section The Error Handling System explains how the instrument reacts to an error and how you the user should respond The second section Cassette Load Errors covers a specific set of errors that are the ones most likely to occur in normal operation Other sec tions cover the Bar Code Reader and instrument diagnostics and quality control status Error Messages and Recovery Procedures This section contains a listing of all the possible error messages that could occur on the VITEK 2 instrument This is the first place you should go to if an error occurs and you need to find out what to do Where to Find It The Error Handling System 8 3 The Error Alarms 8 5 Types of Errors 8 6
19. 3 3 How do You Access the Configuration Screens 3 4 Why and How to Set the Options 3 4 AST Dilution Mode 3 4 Station Name 3 5 KeyClick 3 6 Language 3 7 Time and Date 3 8 Firmware Update Options 3 9 Cassette Erase 3 10 The VITEK 2 User s Manual 3 1 Configuration Overview Configuring the Smart Carrier Station Configuration Overview There are nine configuration options on the SCS Find a Configuration Option Description Screen Name p P On SCS Configuration AST Dilution Mode 3 4 Station Name 3 5 Key Click 3 6 Language 3 7 Time and Date 3 8 Firmware Update Update all SCS files 3 9 Options Update Specific file 3 9 DensiChek Configu DensiChek Connec For future ration tor use Cassette Erase Con Erase Cassette 3 10 figuration Table 3 1 SCS Configuration Options The VITEK 2 User s Manual Configuring the Smart Carrier Station Configuration Overview The options are divided among three screens Station Configuration Includes the AST Dilution Mode SCS Name Key Click Language and Time and Date options Firmware Update Includes options for uploading new software for the SCS DensiChek Contains the option for enabling a power con nection for the DensiChek For future use Cassette Erase Configuration Contains the option for automatically erasing data in the button memory of the cas sette N
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21. 45 Inoculum errors 8 24 Instrument bar code reader 5 12 card capacity 6 5 cleaning 7 46 7 48 connections 4 5 diagnostic tests 8 34 error handling system 8 3 8 14 external controls 4 5 QC Status 5 8 restarting 8 56 screen 4 30 shut down 7 46 status 6 4 Instrument Halted Screen 8 8 Instrument icon 6 8 Instrument name 5 7 defining 5 20 Isolate number field 6 16 The VITEK 2 User s Manual Index K Key Error Messge 4 30 previous screen 4 30 6 12 SCS function 6 19 undo 4 30 Keyboard SCS 2 5 Keyclick volume 5 16 setting 5 25 Keypad instrument 4 30 L Language SCS interface setting 3 7 Light indicator loading station 6 32 6 45 Load errors cassette 8 15 Loading a cassette 6 31 6 34 6 44 6 46 Loading station cassette using 6 32 6 45 Loading batch 6 50 6 51 M Matching AST and ID cards 6 14 Menu system 6 10 6 13 Modifier field 6 17 Modifier field option box for 6 23 Monitoring card processing 6 34 6 47 disposables 6 9 7 3 N Name cassette 5 5 cassette defining 5 20 instrument 5 7 instrument defining 5 20 station setting 3 5 Note definition of 1 5 Index 3 Index O Obtaining instrument temperature 8 35 Optics 4 25 cleaning 7 50 8 43 cleaning with cards processing 8 43 fluorescence 4 25 transmittance 4 26 Option boxes SCS 6 22 Option buttons 6 12 Options configuration See Configu ration options Organism ID field 6 16 Organism ID field option box for 6
22. When the section has been pushed down all the way release the top portion allowing it to rest against the base plate When you perform step 6 two pins on the back of the sec tion should engage the two holes 6 in the base plate and secure the section Press the Press here after completion option but ton to indicate that the section is in place The carousel turns 90 to move the first section out of the way During this time the message Preparing for Section Replacement displays on the screen Repeat this procedure starting at step 4 until all four carousel sections have been replaced The screen displays the following message Carousel Cleaning Replace the incubator access cover now The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument How to Replace the Carousel After Cleaning 9 Hold the retaining pin on the top of the cover to the right and carefully replace the incubator access cover over the carousel Release the retaining pin when the cover is in place 10 Lower the top access door for the carousel being cleaned NOTE Replace the Waste Collection Tray if it was removed earlier 11 Close the Waste Collection door The VITEK 2 User s Manual 7 33 Cleaning the Cassettes Maintaining the VITEK 2 Instrument Cleaning the Cassettes Cassettes should be cleaned monthly or as conditions require How to Clean the Cassettes DANGER The cassettes should be consider
23. cation Pass Fail Pass Fail Pass Fail Pass Fail NA The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Instrument Diagnostics NOTE Some of the diagnostic test functions contain a confir mation screen These are included for the diagnostic tests that take several minutes to run The confirma tion window asks if you want to continue CHECKING THE INSTRUMENT TEMPERATURE Access the Temperature Diagnostics using the path Main Menu gt Utilities Diagnostics gt Temperature If you have a VITEK 2 XL the screen below displays Temperature Incubator A 35 5 C Incubator B 35 5 C Inside 28 0 C If you have a VITEK 2 the screen below displays Temperature Incubator 35 5 C Inside 28 0 C The screen displays the Incubator temperature and the tempera ture inside the instrument The VITEK 2 User s Manual 8 35 Instrument Diagnostics Troubleshooting the VITEK 2 Instrument THE DISPENSER PIPETTOR DIAGNOSTIC TEST NOTE The transport system must be idle to perform this test This test is designed to be performed after installing an Accessory Kit to confirm correct opera tion of the dispenser pipettor station during the error recovery procedure for a dispenser or pipet tor failure 1 Prepare a cassette with the following items two test tubes containing 3 0 ml saline placed in test tube slots 1 and 3 ethree blank test tubes pl
24. cence optics The gloves that contain a powder can interfere with the optics Page 7 50 To prevent damage to the metal contacts on the SCS base unit make sure that you wipe them GENTLY in an up and down motion rather than side to side Page 7 61 Do not disable both the audible and the visual alarms Doing so eliminates all indicators of an error condition which could result in the termination of tests in progress Page 8 5 Do not wear powdered latex gloves while cleaning the fluores cence optics The gloves that contain a powder can interfere with the optics Page 8 43 The VITEK 2 instrument is heavy Use at least two people to move it Lift handles are provided at each end of the instrument Page 1 The VITEK 2 User s Manual xxi Warning Messages Danger Statements xxii The cassette should be considered as potentially contaminated and should be handled appropriately Qualified laboratory per sonnel should take the usual precautions necessary for infec tious agents Page 4 10 The boat should be considered as potentially contaminated and should be handled appropriately Qualified laboratory personnel should take the usual precautions necessary for infectious agents Page 4 14 The sealer station contains a wire that is heated during the seal ing operation Do not reach into the instrument during the seal ing operation Page 4 23 The VITEK 2 User s Manual Warning Messages Biohazardous spills can o
25. make sure that you wipe them GENTLY in an up and down motion rather than side to side Cleaning the Smart Carrier Station Remove the SCS AC power cord from its outlet Clean all surfaces of the SCS base unit keypad dis play and bar code scanner except the glass lens of the scanner Wipe the glass lens of the bar code scanner using a quality lint free lens paper that has been moistened with a commercial glass cleaner If foreign material remains on the surface repeat this step using an alcohol wipe Allow all parts to dry thoroughly before reconnecting the power card and switching the power on The VITEK 2 User s Manual 7 61 Cleaning the Smart Carrier Station Maintaining the VITEK 2 Instrument The VITEK 2 and VITEK 2 XL Maintenance Logs on the fol lowing pages lists recommended maintenance procedures and their frequency Make one copy for your use and keep the origi nal in this manual 7 62 The VITEK 2 User s Manual poumbo sy W V ATIC xx Amuoy x DUIL Ups UE 43 sur 3s4S s ndo xx 91njeJoduro DSnOIE 31 1od qI sn3e s O 1uoumnajsug 15902 ueg dig 7891 JaquieyD umnoeA Tea 2 ees umnoeA 891 uvg seq Tea Ke ISEM R sondo 2291 s sse 1891 y I9snoie 8891 sjeog Wea WV 501 5802 wv ures ssueq 91 SI hI
26. with a secure platform on which to ride The two pins in the well ensure that the cassette can be placed into the boat only in the proper orientation An arrow is molded into the surface of the well to show the proper orientation of the boat when placed in the instrument e The base of each boat is notched in several places These areas are used by the VITEK 2 test card trans port mechanisms that move the boats through the module e Each boat stands on four low friction feet providing a surface on which the boat can easily move The VITEK 2 User s Manual 4 15 What Happens Inside VITEK 2 The VITEK 2 Instrument o Spill prevention The vvell in the top of the boat catches any spills from the cassette 8 Test Card filling Above the cassette well there is a flat surface that extends around the perimeter of the boat This surface becomes the base of the vacuum chamber when the boat reaches the Filler station VITEK 2 Bar Code Reader After a cassette has been loaded onto a boat the test card trans port system moves the boat past the bar code reader station This station reads the information encoded on the bar code label found on each VITEK 2 test card The following information is included in the bar code Test Card type For example a Gram Negative Suscepti bility test card Investigational Use Only IUO flag This tells VITEK 2 if an experimental test card is being processed Test Card expiration date This
27. 2 User s Manual Glossary 1 Glossary Accessory kit Supplied by bioM rieux the accessory kit contains the tubing disk filter and shot tube for the Dispenser station and a con tainer of pipette tubes Aliquot A calculated unit of saline see dispenser pipettor used with the organism culture to inoculate into the test card Antimicrobial Susceptibility Testing AST Testing the susceptibility of certain bacteria to known antibiotic concentrations VITEK 2 helps the diagnostician determine the best medical treatment for the patient s specific strain of micro organism tested Analytical system Located in a portion of the instrument called the Reader Incuba tor station it consists of the carousel and two optics systems The transmittance optics system indirectly measures organism growth as a function of decreasing light transmittance The flu orescence optics system directly measures organism growth or enzymatic activity by direct measurement of a biochemical product Glossary 2 The VITEK 2 User s Manual Glossary Automatic Dilution Mode Bar code Boat One of two possible settings for the Dilution Mode configura tion on the VITEK 2 instrument In Automatic Dilution mode AST suspensions are diluted by VITEK 2 In Pre diluted mode the user prepares AST suspensions prior to loading test cards on the instrument An alphanumeric interface identifier label affixed to each VITEK 2 test card The bar code contain
28. 22 P Pipette tips changing See also Dispos ables 7 14 Pipettor station 4 20 4 21 Povver failures 8 52 Previous screen key 4 30 6 12 Q QC status 5 8 scheduling an automatic report 5 22 setting time for 5 22 R Reader instrument bar code 4 16 Removing boats 7 39 button memory from a cassette 7 36 carousel 7 21 drip pan 7 57 eyected card 6 57 vvaste collection tray 4 28 Index 4 S Saline changing See also Disposables 7 6 7 12 Scanner SCS bar code 2 5 6 24 Scheduling QC status 5 22 Screen contrast 5 17 instrument 4 30 instrument status 6 3 Screen contrast setting 5 25 SCS 2 5 SCS configuration accessing 3 4 SCS advantages of using 6 13 bar code scanner 2 5 6 24 base unit 2 4 configuration options setting 3 4 3 10 configuration screens 3 2 data entry 6 28 data fields 6 16 firmware updates 3 9 function keys 6 19 keyboard 2 5 name 6 15 name setting 3 5 3 6 option boxes 6 22 6 23 parts 2 2 processing cards with 6 25 screen 2 5 slot indicator 6 19 starting 2 7 using 6 13 work flow description 6 26 working without 6 36 Sealer station 4 23 The VITEK 2 User s Manual Setting audible alarm volume 5 25 cassette mode 5 24 date SCS 3 8 dilution mode 5 24 dilution mode SCS 3 4 keyclick volume 5 25 screen contrast 5 25 SCS interface language 3 7 station name 3 5 time for QC status 5 22 time SCS 3 8 Shutting down the instrument 7 46 Slot indicator SCS 6 19 Smart Carrier Statio
29. 5 5 5 17 how to set 5 18 5 27 using option boxes in 5 24 Configuration options SCS 6 25 how to set SCS 3 4 3 10 Configuration screen SCS 3 2 Connections instrument 4 5 Contrast screen 5 17 setting 5 25 D Data entry cassette 6 28 without a SCS 6 48 Index 2 Data fields SCS 6 16 Date SCS setting 3 8 Defining cassette or instrument name 5 20 DensiChek connector 3 2 Dilution mode 3 4 5 11 6 7 changing in cassette setup function 6 42 6 43 setting on the instrument 5 24 setting on the SCS 3 5 status screen indicator for 6 7 Dispenser station 4 18 Displaying version info 8 54 Disposables 7 3 7 20 changing 7 6 7 20 load errors 8 29 monitoring 6 9 7 3 Doors access 4 6 Drip pan cleaning 7 56 7 58 E Ejector station card 4 26 Enabling audible alarm 5 24 bar code reader 5 24 DensiChek connector 3 2 visual alarm 5 24 Error bar code read 8 17 card type 8 16 cassette load 8 15 disposables 8 29 inoculum 8 24 instrument capacity 8 26 messages 8 55 recovering from 8 55 types 8 6 using the status screen 8 7 what to do 8 3 8 14 8 55 The VITEK 2 User s Manual Error handling system 8 3 8 14 Error Message key 4 30 External controls Instrument 4 5 F Filler station 4 22 cleaning the vacuum seal 7 53 Firmware updates SCS 3 9 Fluorescence optics 4 25 cleaning 7 50 Function keys SCS 6 19 I Icons status screen 6 8 ID card matching with AST 6 14 Indicator light loading station 6 32 6
30. 9 Current Dilution Mode Automatic Change Dilution Mode Figure 6 9 Cassette Setup Screen The screen has places for up to ten cassette names You do not enter these names on this screen That is done in the Cassette Names function on the Configuration menu The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards in Cassette Only Mode 2 Select one of the cassette names from the list shown by pressing its corresponding number on the keypad The selected name is highlighted NOTE If you need to add a new cassette name refer to the section Cassette Names on page 5 5 3 If necessary press the Change Dilution Mode option button 6 to change the current dilution mode 8 DANGER Biohazardous spills can occur inside the VITEK 2 instru ment if the Dilution Mode option is not properly set espe cially if pre diluted samples are used with the mode set to Automatic All organism suspensions should be considered as potentially infectious Qualified laboratory personnel should use acceptable procedures for biohazardous mate rial 4 Press the ENTER key to accept the information as shown on the screen The VITEK 2 User s Manual 6 43 Processing Test Cards in Cassette Only Mode Processing VITEK 2 Test Cards Loading a Cassette DANGER The cassette should be considered as potentially contami nated and should be handled appropriately Qualified l
31. Boats for Cleaning DANGER The boats should be considered as potentially contaminated and should be handled appropriately Qualified laboratory A personnel should take the usual precautions necessary for infectious agents NOTE This procedure should be performed while the instru ment is idle If you are performing this procedure to remove only a particular boat the system can continue to process with as few as one boat The VITEK 2 User s Manual 7 39 Cleaning the Boats Maintaining the VITEK 2 Instrument 1 Access the Boat Cleaning function using the path Main Menu gt Utilities gt Maintenance gt Cleaning Boat Cleaning The following screen appears Boat Cleaning Current number of Boats 4 of 4 Remove Boat 2 Press the Remove Boat option button If there are boats in the card transport system and it is not idle the instrument displays the message Card transport system is busy Please try later If the system is idle the instrument moves a boat to the boat dock while displaying this message Boat Cleaning Moving Boat to Boat Dock 71 40 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Boats When the boat is ready for removal the following screen appears Boat Cleaning Boat is at the Boat Dock Please remove it Press here after completion Cancel
32. If you select Yes to continue the cards being processed will be TERMINATED The instrument displays the following prompt Shut Down Shutting down instrument Do you wish to continue Yes The VITEK 2 User s Manual 7 47 Cleaning the Inside of the VITEK 2 Instrument 7 48 2 Maintaining the VITEK 2 Instrument Press the Yes option button to shut down the instru ment The instrument briefly displays the message Shutting Down Instrument while it moves some internal components to their shut down positions When this process is complete the instru ment displays the message Shut down has completed Turn power off when ready Press the AC power switch to shut the instrument off Remove the AC power cordto prevent any possible electrical hazard It is now safe to access the inside of the instrument The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Inside of the VITEK 2 Instrument Cleaning the Test Card Collection Tray 1 Openthe Waste Collection door and remove the test card collection tray 2 Thoroughly clean and dry the tray before replacing it in the VITEK 2 instrument The tray material is designed to withstand any of the fol lowing cleaning methods e Automatic dishwasher with standard laboratory deter gent CAUTION Dishwasher temperatures during the washing and drying cycles
33. Instrument Icon This icon represents the VITEK 2 XL instrument It shows when one of the access doors is open These include the Section A top access door Section B top access door and the center front sliding door Cassette Icon An icon graphic of a cassette appears while a cassette is processing through the Bar Code Reader and Button Memory Reader stations Its presence reminds you to stay near the instrument to ensure that the cassette does not experience any load errors The VITEK 2 User s Manual Processing VITEK 2 Test Cards Introduction How TO MONITOR PIPETTE TIPS AND SALINE The VITEK 2 instrument uses pipette tips and saline for automatic dilution of susceptibility inocula For each disposable the Status screen displays a bar graph and number similar to the one shown in Figure 6 2 Tips 1 4 1 2 34 Figure 6 2 Pipette Tips Status As the disposables are used the bar graphs begin to decrease The graphs are marked to show levels of 4 2 and 34 capacity The number associated with the graph decreases at the same time When the number goes under 40 the value changes to LOW NOTE For pipette tips the number refers to the number of available tips For saline the number refers to the available number of aliquots CAUTION The disposable monitors should be used as an approximate indicator Care should be used to prevent running out of N either disposable during test card processing The
34. Kit 7 5 How to Install an Accessory Kit Part A Saline and TUBING EE 7 6 How to Install an Accessory Kit Part B Pipette Tips 7 14 Cleaning the Carousel 7 21 How to Remove the Carousel for Cleaning 7 21 How to Clean the Carousel 7 28 Hovv to Replace the Carousel After Cleaning 7 29 Cleaning the Cassettes 7 34 Hovv to Clean the Cassettes 7 34 Cleaning the Boats 7 39 How to Remove Boats for Cleaning 7 39 How to Clean the Boats 7 42 How to Replace Boats after Cleaning 7 42 Cleaning the Inside of the VTTEK 2 Instrument 7 46 Shutting Down the VTTEK 2 Instrument 7 46 Cleaning the Test Card Collection Tray 7 49 Cleaning the Optics Normal Maintenance 7 50 Cleaning the Base Pan Vacuum Seal and Vacuum Chamber 7 53 Cleaning the Drip Pan 7 56 Removing the Drip Pan 7 57 Hovv to Clean the Drip Pan 7 58 Replacing the Drip Pan 7 58 Turning the Instrument On 7 59 Cleaning the Smart Carrier Station 7 60 How to Clean the Smart Carrier Station SCS 7 60 VITEK 2 Maintenance Log VITEK 2 XL Maintenance Log The V
35. NOTE This screen does not appear if there are only three boats in the instrument In that case a batch load of three cassettes is assumed NOTE If less than three boats are available or if the card transport system is unavailable the following message appears The card transport system is not available for batch load Load a single boat or try again later 3 Press the option button that corresponds to the number of cassettes that you want to load 6 52 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Batch Loads Smart Carrier or Cassette Only Mode The following screen displays for Smart Carrier Mode Batch Load Load cassette number 1 Abort this cassette NOTE The following screen displays for Cassette Only Mode Batch Load Load cassette number 1 Cassette Name 1hs Dilution Mode Automatic Change Cassette Info Abort this cassette 4 Open the door to the load station place the cas sette in the boat and close the door The VITEK 2 User s Manual 6 53 Unloading the Cassette and Removing Waste Processing VITEK 2 Test Cards The instrument moves the boat away from the load sta tion moves the next boat into the station and redisplays the screen shown in the previous step 5 Repeat Step 4 as required for the other cassettes Unloading the Cassette and Removing Waste This
36. The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Power Failures If power is restored within the 20 minute period normal opera tion is resumed If the power failure continues after the 20 minute period has expired VITEK 2 shuts down the card trans port system but continues to process cards in the carousel Car ousel processing continues as long as the battery in the UPS supplies power If the backup battery in the UPS begins to fail before the 20 minute period expires VITEK 2 terminates the timer and shuts down the card transport system Test cards however continue to process as long as any battery power is available The VITEK 2 User s Manual 8 53 Displaying Version Information Troubleshooting the VITEK 2 Instrument Displaying Version Information Allows you to view the current instrument firmware for the VITEK 2 You may be requested to supply this information to bioM rieux if you need assistance with any of the recovery pro cedures in Table 8 2 1 Access the Version Information function using the path Main Menu gt Utilities Diagnostics Version Info A screen displays similar to the one below BCB 02 26 09 Apr 20 1999 T04 03 Mar 18 1998 BOOT 01 61 18 11 1997 Left 01 61 18 11 1997 Right 01 61 18 11 1997 Dil 01 61 18 11 1997 Pip 01 58 23 10 1997 VacSeal 01 61 18 11 1997 Read A 01 61 18 11 1997 Caro A 8 54 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument How
37. VITEK 2 THE OPTICS VITEK 2 performs its identification and susceptibility analyses by continually monitoring the growth and activity of organisms inside the wells of the test cards Two different optics systems perform ths function FLUORESCENCE OPTICS The fluorescence optics indirectly detect the growth and activity of organisms using a chemical by prod uct of their growth rather than the organisms themselves This chemi cal called a fluorophore absorbs light at a wavelength of 365 nm and immediately re emits the light at a different wavelength of 445 nm A xenon flash tube and optical filters are used to create the specific wavelength of light and a fluores cence detector captures light re emitted by the fluorophore The biochemical system in these wells is designed to produce this substance in direct proportion to the growth and activity of the organisms The amount of re emitted light produced therefore provides an excellent growth activity indicator The fluores cence optics are self checking using an internal reference NOTE The optics should be cleaned periodically See Clean ing the Optics Normal Maintenance on page 7 50 The VITEK 2 User s Manual 4 25 What Happens Inside VITEK 2 The VITEK 2 Instrument Card Ejection TRANSMITTANCE OPTICS The transmittance optics use visible light to directly measure organism growth These optics are based on an initial light reading of a well before s
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39. an AST card it looks at the card in the previous slot For gram negative AST cards the previous two slots are included If it finds an ID card with the same accession number in that slot it declares a match A matched ID AST card set provides two advantages In Automatic Dilution mode the inoculum for the AST card is created automatically in the VITEK 2 instru ment The organism identification called by the ID card is automatically applied to its matching AST card Two gram negative AST cards can be matched to a gram neg ative ID card only one gram positive AST card can be matched to a gram positive ID card 6 14 The VITEK 2 User s Manual Processing VITEK 2 Test Cards About the Smart Carrier Station SCS Station Name In larger laboratories using multiple Smart Carriers provides an automatic identification system for the test cards Each SCS is given a three character name That name is applied to every test card that is processed through the station When you look up a test card on the VITEK 2 directory the source of any test card is instantly known Smart Carriers can be named for the technologists using them for a laboratory location or for the types of specimens processed through them Safety The cassette portion of the SCS provides a safe and convenient method of transporting multiple test cards from the workbench to VITEK 2 Once a sample is placed in the cassette the technologist never has to touch it again
40. been resolved This status can be cleared only by resolving the condition that generated the original message Cleaning This status indicates that either all four boats or at least one carousel section have been removed for clean ing Test card processing cannot resume unless all carousel sections or at least one boat are replaced KNOWING How MANY TEST CARDS YOU CAN LOAD The MAX Available Slots field 6 indicates the number of unoccupied slots in the instrument You can load one or more cassettes containing up to that number of test cards If you load more than that number some of the test cards will not be pro cessed unless additional slots become available by the time the test cards reach the carousel The VITEK 2 User s Manual 6 5 Introduction Processing VITEK 2 Test Cards The number you see in the MAX Available Slots field depends on the VITEK 2 instrument you have and the optical configura tion of the instrument Instrument Max Available Optical Configuration VITEK 2 fluorescence optic MAX Available Slots 60 Leer of transmittance Optics VITEK 2 XL fluorescence optic MAX Available Slots 120 Section A Available ID Slots 60 2 sets of transmittance optics Sections A amp B VITEK 2 XL 2 sets of fluorescence MAX Available Slots 120 optics Sections A amp B 2sets of transmittance optics Sections A amp B Table 6 1 MAX Available Slots 6
41. for laboratory conditions WHY USE THIS OPTION The default setting for the alarm volume is at the midpoint of its range Use this option to make the appropriate adjustments as required The option includes a test function so that you can hear the alarm while changing it How TO SET THIS OPTION The procedure for setting this configuration option is How to Set a Range Value on page 5 25 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How Configuration Options Affect VITEK 2 Visual Alarm Enable The instrument causes the interface screen display to blink to alert you to an error condition The blinking terminates when you press any key on the instrument keypad WHY USE THIS OPTION Since the VITEK 2 instrument and workstation each have an audible alarm the visible alarm may be unnecessary If so use this option to Disable the alarm CAUTION Do not disable both the audible and visual alarms on the instrument unless it is located very near to the workstation N Doing so makes it more difficult to know that an error con dition exists How TO SET THIS OPTION The procedure for setting this configuration option is How to Use Option Boxes on page 5 24 The VITEK 2 User s Manual 5 15 How Configuration Options Affect VITEK 2 Configuring the VITEK 2 Instrument Keyclick Volume The VITEK 2 instrument interface uses a touch pad type of keypad It sounds an audible click when you press each key The v
42. for the manual but have the advantage of addressing only what is in that chapter Page Headers Each page in the manual has a header which can serve as a visual aid to help you find a topic The inside portion of the header the side closest to the binding always shows the chapter title The outside portion of the header shows the title of the current section Index Found at the end of the manual the index is the most useful device for finding individual topics throughout the manual The VITEK 2 User s Manual 1 3 Typographic Conventions How To Use This Manual Typographic Conventions The following typographic conventions are used throughout the manual Names of Keys The names of keys either on the VITEK 2 instrument keypad or the Smart Carrier keyboard are shown in capital letters bold and italic Example Press the UP or DOWN ARROW keys Action objects In a procedural step the object of the action you take is highlighted in bold italics Example Open the Cassette Load station by sliding the station door up References References to other sections in the manual are shown in italics Example See the section Monitoring Test Card Processing on page 6 47 1 4 The VITEK 2 User s Manual How To Use This Manual Typographic Conventions Notes A NOTE contains information of special interest Cautions A CAUTION statement is used when a particular action may affect the outcome of a t
43. held magnetically and should swing down on its hinges when you pull on it at both ends 2 Grasp the handle of the drip pan see figure below and carefully pull it from the instrument DANGER The contents of the drip pan may include biohazardous l materials Take appropriate precautions The VITEK 2 User s Manual 7 57 Cleaning the Drip Pan Maintaining the VITEK 2 Instrument How to Clean the Drip Pan The drip pan should be thoroughly cleaned and dried before it is replaced in the VITEK 2 instrument The pan material is designed to withstand any of the following cleaning methods Automatic dishwasher with standard laboratory detergent CAUTION Dishwasher temperatures during the washing and drying cycles must not exceed 85 C 185 F Exceeding this tem N perature will cause damage to the drip pan Use the top rack of the dishwasher 10 bleach solution Phenolic cleaning solution NOTE To disinfect a contaminated surface use the 10 bleach solution and allow it to remain in contact with the contaminated surface for five minutes Replacing the Drip Pan 1 Holding the pan by its handle push it into the space provided for it under the front of the instrument 2 Close the bottom access door by pushing it up The door is held in place magnetically 7 58 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Drip Pan Turning the Instrument On 1 Move the AC p
44. in above Minimum installation altitude 100m Maximum installation altitude 2000m Ambient room temperature 20 C to 30 C Shipment and storage temperature 20 C to 50 C Relative humidity 40 to 80 non condensing Pollution degree 2 in accordance with IEC 664 Overvoltage Category II per IEC 664 The VITEK 2 User s Manual Electrical Characteristics Appendix Hardware Specifications 2 VITEK 2 XL Characteristics Input voltage 200 240 VAC at 50 60 Hz 200 240 VAC at 50 60 Hz 100 120 VAC at 50 60 Hz 100 120 VAC at 50 60 Hz Maximum input current 4 amps 120 VAC or 2 amps 240 VAC 5 amps 120VAC or 2 8 amps 240 VAC Nominal input current 1 5 amps 120 VAC or 0 75 amps 240 VAC 2 75 amps 120 VAC or 1 75 amps 240 VAC Power 150 watts nominal 471 200 watts nominal 569 watts peak watts peak Heat 512 BTU HR nominal 682 BTU HR nominal Power cord Detachable 3 wire with Detachable 3 wire with ground per IEC 227 or IEC 245 ground per IEC 227 or IEC 245 The VITEK 2 User s Manual Appendix 3 Appendix Hardware Specifications Optical Characteristics Appendix 4 NOTE The specifications below apply to both the VITEK 2 and the VITEK 2 XL TRANSMITTANCE OPTICS Emission wavelengths 660 nm 590 nm 568 nm 430 nm LED Percent transmission range 3096 to 10096 1096 FLUORESCENCE OPTICS Emission wavelength 365 nm Detectio
45. linked slots Erase all the data in 1 Press the F10 key A confirma the button memory tion vvindovv appears gt lt chip 2 Press the F1 key to erase the button memory chip Table 6 3 Summary of SCS Functions NOTE The F7 key is currently unassigned The VITEK 2 User s Manual 6 21 About the Smart Carrier Station Processing VITEK 2 Test Cards Option Boxes The Organism ID Ancillary Test and Modifier fields are restricted that is they accept only certain data When entering data manually via the keyboard option boxes provide access to the acceptable data entries ORGANISM ID This field has two option boxes depending on the AST card type you enter in the Card Type field For example Positive Negative Organism ID Organism ID gt staaur gt esccol staneg promir entspp provul strpre pseaer ANCILLARY TESTS The contents of the option boxes for this field depend on the type of card you enter in the Card Type field For example the option box for a gram positive card would be similar to the fol lowing Ancillary Tests blac The VITEK 2 User s Manual Processing VITEK 2 Test Cards About the Smart Carrier Station MODIFIER The option box for the Modifier field contains six default entries mod 1 to mod 6 When this data reaches the work station computer the entry is matched to one of the first six entri
46. move the cursor to the Station Name field In the Station Name field type up to three charac ters and press ENTER Press the F2 key to exit the SCS Configuration screen or the NEXT or PREVIOUS SCREEN keys to access other configuration screens The SCS custom keyboard does not have an audible click when you press a key This option enables an audible click from the instrument every time you press a key HOW TO ENABLE THIS OPTION 1 2 3 6 Press the F4 key to access the Configuration screen Press the DOWN ARROW key to move the cursor to the Enable Key Click field In the Key Click field press 1 to turn the key click off 2 to turn the key click on Press the F2 key to exit the SCS Configuration screen or the NEXT or PREVIOUS SCREEN keys to access other configuration screens The VITEK 2 User s Manual Configuring the Smart Carrier Station Why and How to Set the Options Language The SCS interface is programmed in six languages English French talian German Spanish Japanese By setting this configuration option you can work on the SCS in the language of your choice How TO SET THIS OPTION 1 Press the F4 key to access the Configuration screen 2 Press the DOWN ARROW key to move the cursor to the Language Choice field 3 Inthe Language field press the HELP key to display an option box with the available languages 4 Press the UP or DOWN ARROW keys to select a languag
47. must not exceed 85 C 185 F Exceeding this tem K perature will cause damage to the cassettes Use the top rack of the dishwasher 10 bleach solution Phenolic cleaning solution NOTE To disinfect a contaminated surface use the 10 bleach solution and allow it to remain in contact with the contaminated surface for five minutes 3 Replace the test card collection tray in the Waste Collection station The VITEK 2 User s Manual 7 49 Cleaning the Inside of the VITEK 2 Instrument Maintaining the VITEK 2 Instrument Cleaning the Optics Normal Maintenance NOTE Perform procedure Shutting Down the VITEK 2 Instrument on page 7 46 before proceeding with this procedure DANGER The instrument contains an ultraviolet light source Make sure that the fluorescence optics unit is closed before resum A ing instrument operation CAUTION Do not wear powdered latex gloves while cleaning the fluo rescence optics The gloves that contain a powder can inter A fere with the optics 1 Open the Waste Collection door 2 Lift the top access door This exposes both the fluores cence 69 and the transmittance optics shown in the figure to the right 7 50 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Inside of the VITEK 2 Instrument Both optics consist of units that are hinged on the bottom and held in place by spring loaded levers The transmittance optics consists of two
48. of these units while the fluorescence optics have only one NOTE The remainder of this cleaning procedure is the same for both optics 3 Using your right hand grasp the optics unit and place your thumb on the lever 9 see figure at right 4 Push down on the lever to j release the unit and allow it to rotate on n its hinges 5 Inspect the glass on both surfaces for cracks or scratches NOTE Any apparent crack or scratch should be reported to bioM rieux 6 Using a quality lint free lens paper that has been slightly moistened with a commercial glass cleaner clean the glass surfaces The VITEK 2 User s Manual 7 51 Cleaning the Inside of the VITEK 2 Instrument 10 Maintaining the VITEK 2 Instrument If foreign material remains on either surface repeat this step using an alcohol wipe Squeeze out excess alcohol before using and dry the surface with lens paper Make sure that you do not leave streaks on the glass Rotate the unit back into place while pushing down slightly on the lever until it is secured Replace the empty test card collection tray in the Waste Collection station Close the top access door Close the Waste Collection door NOTES After cleaning the optics perform the Opti cal Diagnostic Test on page 8 48 If you are not performing the remaining cleaning pro cedures in this section skip to the procedure Turning the Instrument On on page 7 59 The VITEK 2 User
49. open the instrument generates an error condition After cleaning the optics perform the Optical Diag nostic Test Optical Diagnostic Test 1 Access the Optical Diagnostic Test using the path Main Menu gt Utilities Diagnostics Optics NOTE If you have a VITEK 2 XL the following screen appears allowing you to select a Reader Optical Test Reader A Reader B 8 48 The VITEK 2 User s Manual Troubleshooting the VITEK 2 InstrumentCleaning and Verifying the Optics with Cards Processing The following screen appears for either the VITEK 2 or VITEK 2XL Optical Test About to perform optical test Do you wish to continue 2 Press Yes to continue 3 Ifthe optical test failed call bioM rieux 4 Once the test is complete press PREVIOUS SCREEN to exit the window The VITEK 2 User s Manual 8 49 Boat Transport Positions Troubleshooting the VITEK 2 Instrument Boat Transport Positions The diagram below shows the six boat transport positions It is important to know the boat positions inside the instrument to aid in the troubleshooting of jams involving the card transport system e t Seal Stati 4 d Unload Vacuum Station Sp ut Seal Station Gs ard Load Unloa Station Cassette Load Unload 1 Pipettor Button Memory Station Station Remove replace boats between stations and
50. section describes two procedures that you need to perform on a regular basis One is to remove empty cassettes from the instrument which should be done whenever the light at the Cas sette Load station is blinking The other is to remove ejected test cards which should be done routinely whenever a new cas sette is loaded Performing these activities ensures that VITEK 2 can continue to support your laboratory s work load The VITEK 2 User s Manual Processing VITEK 2 Test Cards Unloading the Cassette and Removing Waste How to Unload a Cassette During test card processing test cards are unloaded from the cassette and placed into the carousel at the Card Reader and Incubator station This means that when the boat and cassette return to the unload station only the specimen test tubes and the severed transfer tubes remain in the cassette The cassette must be removed so that the boat is available to accept another cas sette 1 When you are processing test cards look for the green indicator light at the unload station to be blink ing This indicates that an empty cassette is at the station For more information about the indicator light see the section Using the Cassette Load Station on page 6 32 or on page 6 45 2 Open the cassette unload door and remove the cassette from the boat NOTE The boat itself should not be removed 3 Close the cassette unload door The VITEK 2 User s Manual 6 55 Unloading the Casse
51. the top of the screen should show a status of Warming or OK The Warming status means that the carousel temperature is not yet within its specified range This can take several minutes VITEK 2 is ready to begin processing cards when the Status field shows OK For more information about the Status Screen see page 6 3 4 8 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 What Happens Inside VITEK 2 The VITEK 2 instrument is an integrated system combining the tasks of sample preparation test card inoculation and test card incubation and reading Test Card Processing Cycle The parts and functions of the VITEK 2 instrument can best be described by following a test card through the phases of a typi cal processing cycle The following table summarizes this cycle and shows you where you can find more details about a particular component of the VITEK 2 instrument Component Processing Phase 7 Cassettes Test card transport 4 10 Cassette Load and Unload Test card transport 4 13 Station Boats Test card transport 4 15 Bar Code Reader Sample preparation 4 16 Button Memory Reader Sample preparation 4 17 Dispenser Pipettor Station Sample preparation 4 18 Filler Station Sample preparation 4 22 Sealer Station Sample preparation 4 23 Test Card Incubation and Test card analysis 4 23 Reading Card Ejection Test card transport 4 26 Waste Collection Station Test card transport 4 28 User Interface S
52. to Use Error Message and Recovery Table How to Use Error Message and Recovery Table Table 8 2 in this section contains all of the messages that can be displayed in the error message queue The Error Message and Recovery table is designed to provide you where possible with the recovery procedure that is most likely to restore the instrument to normal operation If the described procedure does not prevent recurrences of the error call bioM rieux for assistance 1 The VITEK 2 User s Manual Find the Primary Error Code from the error mes sage in the first column of the table Primary error codes are listed alphabetically Find the Secondary Error Code from the error mes sage in the second column of the table Read and follow the directions in the Recovery Pro cedure found in the third column and address accordingly If the error reoccurs or the recovery procedure advises a call to bioM rieux inform the service rep resentative of the error number found in the lower right portion of the message queue 8 55 How to Use Error Message and Recovery Table Troubleshooting the VITEK 2 Instrument How to restart the instrument Several of the recovery procedures in the table instruct you to restart the instrument To do this 1 Perform the instrument shutdown procedure on page 7 46 2 Wait at least 10 seconds 3 Move the AC power switch to the ON position 8 56 The VITEK 2 User s Manual eouejsisse 10
53. to provide you with the information you need to resolve the problem We refer to this process as the Error Han dling System Figure 8 1 illustrates these elements Instrument Programming The VITEK 2 Instrument nterprets sensor signal Instrument Sen Attempts to self correct B gt Selects error message sors I Activates alarms Send message to queue Error Message Queue Visual Audible Alarms The VITEK 2 User Troubleshooting Chapter Error Message Queue Look up error code Access the queue i Follow recovery proce Record message and dure code Figure 8 1 The VITEK 2 Error Handling System The VITEK 2 User s Manual 8 3 The Error Handling System Troubleshooting the VITEK 2 Instrument The first element of the Error Handling System is the VITEK 2 instrument First it must detect the error In many cases the instrument will attempt to correct the problem by retrying an operation If that fails the instrument selects the appropriate error message activates the error alarms and places the mes sage in the error message queue The second element of the Error Handling System is you the VITEK 2 user First you must respond to the alarm by accessing the error message queue on the instrument interface read and record all messages in the queue look up the error code from the message in this chapter
54. to set up the test cards and specimens for a cassette How TO GENERATE A CASSETTE WORKSHEET You generate Cassette worksheets at the VITEK 2 workstation For information please refer to this topic on the VITEK 2 Online Help System How TO UsE THE CASSETTE WORKSHEET The Cassette Worksheet shown in Figure 6 8 is designed to help you organize a set of test cards and specimens for a cas sette The VITEK 2 User s Manual 6 39 Processing Test Cards in Cassette Only Mode Processing VITEK 2 Test Cards Date 2 12 99 bioM rieux Page 1 WSVT2 R2 02 Cassette Report Cassette ID Tests Instrument Test Type Accession ID Organism Modifier Ancillary Tests Dy Bee eo es ba yasa ete oe kas p Pr 0000000 EE EE 0063 x s a Bags Be EE HEEN CMM ge SR dE ea e a geet EE EE EE ber KE e Eet ee Keren UL EE UR EE EEN e Et Ee dE EE EECH beu tye SX matu EE Rat Figure 6 8 The Cassette Worksheet Cassette ID Tests lnstrument Name 6 40 Fill in the cassette name here Fill in the number of test cards being placed in the cassette Fill in the name of the VITEK 2 instrument into which you placed the cassette The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards in Cassette Only Mode Fields Use these fields to fill in the applica ble information about the tes
55. to the dispensing chamber 2 Anoptical sensor detects when the chamber is full 2 5 ml and closes the valve 3 The dispensing chamber rotates into position over the AST card s test tube 4 The air pump is activated forcing the saline into the tube at a controlled rate that minimizes splashing The VITEK 2 User s Manual 4 19 What Happens Inside VITEK 2 The VITEK 2 Instrument THE PIPETTOR The pipettor station transfers a preset volume of an organism suspension from its test tube into the test tube of its mated AST card Disposable Pipette Tips To prevent contamination VITEK 2 uses single use disposable pipette tips O Container The container holds up to 350 pipette tips It has an internal mechanism that ensures proper delivery of each pipette tip to the displacement pump Displacement Pump not shown The displacement pump withdraws a specified volume of inoculum for dilu tion in the inoculum tube of an AST card NOTE The displacement pump is not normally visible as it is located directly behind the interface screen and keypad 4 20 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 HOW THE DISPLACEMENT PUMP WORKS The displacement pump is part of a larger assembly that per forms the pipetting and transfer of the suspension when VITEK 2 is in the Automatic dilution mode Here is how it works 1 The container drops a pipette tip into position 2 Th
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57. workstation where it is recorded with the date and time the report was taken The configuration option allows you to schedule up to three times of day when a QC report is taken and recorded at the workstation The Instrument Quality Control Status includes two parameters Carousel Incubator Temperature Optics Systems The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How Configuration Options Affect VITEK 2 The instrument continuously monitors these parameters so that their status can be determined at any time The user interface provides a function called Display Instrument QC Status to access this information QC Status Previous status recorded 13 55 01 15 99 Current Instrument Status O Temperature 35 7 C Optical Systems OK O Record Cancel Figure 5 1 The Instrument QC Status Screen This field displays the time and date that the previous QC status was recorded The field is blank if this function has never been used before O Temperature For the VITEK 2 this field displays the cur rent carousel temperature in degrees Celsius For the VITEK 2 XL the temperatures for carousel A and B are displayed Optical Systems This field displays the status of the fluo rescence and transmittance optical systems O Record Press this option button to transmit the QC status information to the workstation During the transfer the mes sa
58. you can see a listing of the test cards in the Directory window Additional information is provided once the test cards reach the Card Incubator and Reader station and are read for the first time NOTE The VITEK 2 instrument should be attended during the first minute after a cassette is loaded and the boat moves forward to process cards This period is denoted by the presence of the cassette icon on the VITEK 2 Status screen See also the section Cassette Load Pro cessing Errors on page 8 15 6 34 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards Using the Smart Carrier Station ABOUT THE CASSETTE ADDRESS The cassette address which appears in the VITEK 2 Directory screen at the workstation provides a means to identify each test card in the VITEK 2 instrument The following figure illustrates two examples RMT 03 Apr 03 08 35 40 URN 11 Mar 29 13 45 01 Figure 6 7 The Cassette Address A cassette address has three basic parts Using the first example from Figure 6 7 the following table shows what each of these parts mean and how they are derived The Cassette For taken feum Address Section example The cassette RMT The three character cas name sette name that is entered on the Configuration screen of the Smart Car rier Station The slot position 03 The actual test card posi 1 15 of the test tion as read by the card in the cas VITEK 2 bar code sette read
59. you have a VITEK 2 XL a screen appears allowing you to select a Reader Optics Cleaning Reader A Reader B 8 44 The VITEK 2 User s Manual Troubleshooting the VITEK 2 InstrumentCleaning and Verifying the Optics with Cards Processing You have five 5 minutes from the time that you press the Yes option button to complete the cleaning procedure Test card processing automatically resumes after that time It then displays the following screen Optics Cleaning Clean the optics Cleaning completed 3 Open the Waste Collection station door and remove the test card collection tray Dispose of any test cards in the tray The VITEK 2 User s Manual 8 45 Cleaning and Verifying the Optics with Cards ProcessingTroubleshooting the VITEK 2 Instrument 4 Lift the top access door of the instrument This exposes both the fluores cence 69 and the transmittance 9 optics shown in the figure to the right This provides easier access to the optics and an opportunity to clean this component also Both optics consist of units that are hinged on the bottom and held in place by spring loaded levers The transmittance optics consists of two of these units while the fluorescence optics have only one NOTE The remainder of this cleaning procedure is the same 8 46 for both optics Remember that for the transmittance optics you do each step for both unit
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61. 1 Use the procedures in this chapter for instructions on how to set an option 3 Operate the system to validate the settings During this time evaluate the physical parameter settings for the options in Table 5 2 4 Change any option as required How Configuration Options Affect VITEK 2 Cassette Names The Cassette Names option allows you to define up to ten three character VITEK 2 users When a cassette is processed the Cassette Name becomes part of what is called the cassette address When viewing test card directories on the VITEK 2 workstation the cassette address can be used to filter the direc tory view so that only those test cards processed by a particular user are seen Cassette names can represent the technologists who process test cards sections of the laboratory from which test cards originate or any identification scheme that you want to use The VITEK 2 User s Manual 5 5 How Configuration Options Affect VITEK 2 Configuring the VITEK 2 Instrument WHY USE THIS OPTION The Cassette Names option is designed for work flows in which a Smart Carrier Station SCS is not used A Cassette Name that you define replaces the cassette name that would be read from the cassette s button memory You should use this option if you do not have an SCS or if you have a work flow that does not require the use of an SCS NOTE If the VITEK 2 instrument is in Smart Carrier mode the Cassette Names option cannot be acce
62. 2 Displaying Version Information 8 54 How to Use Error Message and Recovery Table 8 55 How to restart the instrument 8 56 Error Message and Recovery Table 8 57 Appendix Hardware Specifications Glossary Index xii The VITEK 2 User s Manual List of Figures List of Figures FIGURE PAGE 2 1 m al SCS Screen e rei ab 2 8 5 1 The Instrument QC Status Screen 5 9 6 1 The VITEK 2 Status Screen in Cassette Only Mode 6 4 6 2 Pipette Tips Status EE 6 9 6 5 VITEK 2 Matti Menu 6 10 6 4 Detailed Structure of the VITEK 2 Menu System 6 11 6 5 The Previous Screen Key sez da d 6 12 6 6 Fields of the Data Entry Screen 6 16 6 7 Th Cassette Address mun um eda ee 6 35 6 8 The Cassette Worksheet 6 40 0 0 Cassette Setup Sereeli eene S 6 42 6 10 The Cassette Address 6 49 6 11 The Waste Collection Station 6 57 7 1 The VITEK 2 Status Screen 7 3 7 2 VITEK 2 XL Carousel Cleaning Screen 7 22 7 3 Removing a Carousel Section 7 2
63. 5 7 4 Removing the Button Memory Module 7 36 7 5 Replacing the Button Memory Module 7 38 8 1 The VITEK 2 Error Handling System 8 3 8 2 Instrument Halted Status Screen 8 8 8 3 Ihe VITER2 StatUuSSereelyu uns u s taco dod Pid simt cid poet 8 9 8 4 Bar Code Error Message 8 18 8 5 Screen for Resolving Bar Code Errors 8 19 8 6 Card Type Error Message 8 22 8 7 Inoculum Source Error Message 8 25 8 8 Card Capacity Warning Message 8 27 8 9 Boat Transport Positions 8 50 The VITEK 2 User s Manual xiii General Warnings IMPORTANT IMPORTANT IMPORTANT The VITEK 2 User s Manual The user is advised to read and understand all instructions in this manual to be able to derive the best performance from VITEK 2 The configuration that you have purchased is adapted to the legislation and standards of the different countries it will be sent to For this reason it may differ from the one pre sented in this document However this will have no effect on the performance of your VITEK 2 For further inf
64. 6 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Introduction DANGER X THE CASSETTE NAME FIELD When the instrument is in Cassette Only mode 9 this field displays the name of the most recently used cassette That cas sette name is applied to all cassettes unless you elect to change it When the instrument is in Smart Carrier mode the field displays the name SCS THE DiLUTION MODE INDICATOR This field displays only when the instrument is in Cassette Only mode The field then tells you whether the instrument is set to the Automatic or Pre Diluted dilution mode This field should be checked before loading a cassette Biohazardous spills can occur inside the VITEK 2 instru ment if the Dilution Mode option is not properly set espe cially if pre diluted samples are used with the mode set to Automatic All organism suspensions should be considered as potentially infectious Qualified laboratory personnel should use acceptable procedures for biohazardous mate rial The VITEK 2 User s Manual 6 7 Introduction Processing VITEK 2 Test Cards STATUS SCREEN ICONS The area on the Status screen just above the disposables graphs is reserved for the Status screen 8 icons VITEK 2 Instrument Icon This icon represents the VITEK 2 instrument It shows when one of the access doors is open These include the front access door on the front of the instrument and the top access door VITEK 2 XL
65. 8 provides trouble shooting and maintenance procedures for the VITEK 2 instrument The VITEK 2 User s Manual 1 1 Printed vs Online Documentation How To Use This Manual Printed vs Online Documentation The documentation for the VITEK 2 system consists of both this printed manual and online help The division between the two types of documentation is distinct and straightforward This printed manual covers the VITEK 2 instrument and the Smart Carrier Station including both the hardware and the pro grammed user interfaces The online help documentation which is found in the user inter face of the computer workstation covers only the programmed user interface that you see at the workstation This division allows for the possibility that the computer workstation may be in a different location than the VITEK 2 instrument and Smart Carrier Station The VITEK 2 User s Manual How To Use This Manual How to Find Topics and Procedures How to Find Topics and Procedures There are four devices in the manual to help you find a topic or procedure General Table of Contents This table is located in the front of the manual and includes the entire document You can use this table to locate major headings throughout the manual The table also includes a list of figures Chapter Table of Contents Each of the succeeding chap ters begin with their own tables of contents They contain the same information as the general table
66. Carousel Cleaning Remove Section Now Current number of Sections 4 of 4 Press here after completion 6 carousel is removed in four sections Grasp the first carousel section and pull it slightly forward toward the front of the instrument You should then be able to pull the section up and to the right as shown in Figure 7 3 Figure 7 3 Removing a Carousel Section The VITEK 2 User s Manual 7 25 How to Remove the Carousel for Cleaning Maintaining the VITEK 2 Instrument 7 Press the Press here after completion option but ton to indicate removal of the carousel section The following screen displays Carousel Cleaning Current number of Sections 3 of 4 Press here after completion The carousel turns 90 so that the next section can be removed During this time the message Preparing for Section Removal displays again on the screen 8 Repeat this procedure starting at step 6 until all four carousel sections have been removed 7 26 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument How to Remove the Carousel for Cleaning 9 Press the Press here after completion option but ton The following screen displays Carousel Cleaning Replace the incubator access cover now 10 Hold the retaining pin on the top of the cover to the right and carefully replace the incubator access cover over t
67. D field for slot 1 when the screen is first accessed All fields are empty unless previous data was entered for that slot 1 Access the Data Entry screen The SCS displays the Data Entry screen see Figure 6 6 on page 6 16 automatically whenever a cassette 1s firmly seated on the SCS base unit 2 Select the correct slot Make sure that the data entry screen is displaying the correct slot 1 15 Use the NEXT SLOT or PREVI QUS SLOT keys Make sure also that the cursor blinking bar is in the correct field Use the UP or DOWN ARROW keys The VITEK 2 User s Manual 6 28 Processing VITEK 2 Test Cards Processing Test Cards Using the Smart Carrier Station 3 Enter the data Field Using the bar code scanner Using the keyboard Accession ID Card Type Organism ID AST card Ancillary Test Modifier Scan the bar code label on the speci men Scan the bar code label on the card Type the ID into the Acces sion ID field Type the 18 digit code from the bar code label on the test card NOTE The SCS does not allow you to enter expired cards Scan an organism ID from the SCS job aid card Scan a test from the SCS job aid card Scan a modifier from the SCS job aid card Place the cursor in the Organ ism ID field and press the Help key Select an organism from the option box Place the cursor in the Ancil lary Test field and press the Help key Select a test f
68. G After a cassette is loaded the test cards in it are scanned by the bar code reader in VITEK 2 This information is sent to the workstation so that you can see a listing of the test cards in the Directory window Additional information is provided once the test cards reach the Card Incubator and Reader station and are read for the first time The VITEK 2 User s Manual 6 47 Processing Test Cards in Cassette Only Mode Processing VITEK 2 Test Cards How to Enter Data for a Cassette 6 48 During the first minute after you load a cassette the bar code on each test card is read From this bar code reading the instru ment knows the number of test cards in the cassette the type of test cards and the position of each test card This information along with the cassette name you selected in the Cassette Setup function is sent to the workstation The information can be viewed in the Cassette Edit window which is part of the VITEK 2 workstation software You can access that window and using the Cassette Worksheet fill in the remaining information for the cassette once the test cards have been loaded into the carousel For information on using the Cassette Edit window please refer to this topic on the Online Help System The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards in Cassette Only Mode ABOUT THE CASSETTE ADDRESS RMT 03 Apr 03 08 35 40 URN 11 Mar 29 13 45 01 The cassette
69. How TO RESOLVE AN INOCULUM ERROR 1 Press the Error Message key to display the mes sage queue For an inoculum source error you see the following screen Message Queue Processing Error Inoculum source not available for Slot NN Message of 1 12 00 119 Figure 8 7 Inoculum Source Error Message 2 Open the Cassette Load door and remove the cas sette DANGER The cassette should be considered as potentially contami nated and should be handled appropriately Qualified labo ratory personnel should take the usual precautions necessary for infectious agents 1 Another inoculum error message is Grouping Error at Slot NN The VITEK 2 User s Manual 8 25 Cassette Load Processing Errors Troubleshooting the VITEK 2 Instrument 3 Place the inoculum source next to the appropriate slot 4 Place the cassette back into the Cassette Load sta tion and close the door This restarts the processing cycle for the cassette Card Capacity Errors As the bar codes on the test cards are read the cards are counted The count is compared to the number of empty slots currently available in the reader carousel If the number of cards exceeds the number of available slots The cassette Is backed out to the Cassette Load station The error alarm is activated 8 26 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors How TO RESOLVE A CARD CAPACI
70. ITEK 2 User s Manual xi Table of Contents 8 Troubleshooting the VITEK 2 Instrument Introduction ELE Re ER Ad LESS 8 1 Error Messages and Recovery Procedures 8 1 Where to Find It 8 1 The Error Handling System 8 3 The Error Alarms EE 8 5 Types of EHOIS ENEE D 8 6 The Status Screen in an Error Condition 8 7 Reviewing an Instrument Halted Screen 8 12 Reviewing a Status Screen with Messages 8 13 Reviewing a Status Screen with Errors 8 14 Cassette Load Processing Errors 8 15 Why Do They Occur 8 16 Work Flow Considerations 8 17 Bar Code Read Failure 8 17 SCS and Bar Code Reader Conflict 8 21 Inoculum Errors 8 24 Card Capacity Errors 8 26 Disposables Errors 8 29 Working Without the VITEK 2 Bar Code Reader 8 30 How to Enter Bar Codes Manually 8 31 Instrument Diagnostics 8 33 Instrument Diagnostics Menu 8 33 Diagnose KEE 8 34 Cleaning and Verifying the Optics with Cards Processing 8 43 Optical Diagnostic Test 8 48 Boat Transport Positions 8 50 Power Failures p ERREUR 8 5
71. Memory Reader Dispenser Pipettor Filler and Sealer SCS Base Unit See Smart Carrier Station Glossary 8 The VITEK 2 User s Manual Glossary Sealer station This station a part of the Sample Preparation System seals each test card by cutting and sealing its associated inoculum transfer tube with a hot wire Smart Carrier Station SCS A laptop computer like device used to aid in setting up the test and for entering test information It consists of the base unit computer the display black and white LCD 40 characters wide by 12 lines high bar code scanner and the keyboard slides under base unit The system is optional and offers many productivity and secu rity features for the user It has user configurable modes for automatic dilution for matching ID and AST Test cards Test card A 3 1 2 by 2 1 4 inch 76 2 by 49 45 mm cassette card with 64 growth wells for biological testing in the VITEK 2 system Each well contains an air dried suspension of a biochemical or drug used to identify and suggest treatment for microbial infec tions in patients The VITEK 2 User s Manual Glossary 9 Glossary Transmittance optics A combination of light emitting diodes emitters and photo diodes used to read the growth results in the card wells Also see fluorescence optics User interface UIF The portion of the VITEK 2 system in which the user and the system s software interact The system has three user interfac
72. OTE The Smart Carrier Firmware Status screen has no options to set It only displays the current version of the Smart Carrier Station firmware When Should Configuration Options be Set SCS configuration options should be set before a cassette is inserted and information is entered for the test cards In fact the Station Configuration screen is the first screen displayed on an SCS for which a Station Name has not been defined NOTE One exception to this is the Program Updates option You do not need to use that screen until you receive instructions from bioM rieux to do so The VITEK 2 User s Manual 3 3 Why and How to Set the Options Configuring the Smart Carrier Station How do You Access the Configuration Screens The Station Configuration screen is accessed by pressing the F4 key v p You then press the PREVIOUS x or NEXT SLOT keys to switch to the other screens Why and How to Set the Options AST Dilution Mode An AST or Antimicrobial Susceptibility Test uses an inocu lum that is specifically diluted according to the type of test card being used These inocula can be prepared manually by the technologist or prepared automatically by VITEK 2 at the Dis penser Pipettor station The AST Dilution mode setting is transferred to the VITEK 2 instrument via the button memory on the cassette If you set the AST Dilution Mode to automatic every AST in a cassette has its inoculum diluted by VITEK 2 If the AST D
73. PUD ASVSSaP 40445 c g QPL 8 61 The VITEK 2 User s Manual SJn98J ulejqoJd eui Ji xn L yyolq IECH 9 st 1 nun Kov NITIA SAOIAANd 91 sse1d po amp ejdsrp you st r s YEH oui JI CALON UEL u uo uollnq uondo OF eui sseJg Z zG Z eBed uo seinpeooud eui JO 6 dels o SJ00p uonoej oo 9 SeM pue ssoooe 1uBu do eui 9so 2 9 19AO SS E 10160 2 1 eui eoe deu S N SSE y Olul yor pJeo eui usnd s 3194 j T snole eui pue Jepeo peo y U M Q p wwef puedo ou si 3194 181 ens v lesno1e9 eui Ou ped eui usnd s eJeuj J JesnoJeo eui pue peau 1epeoiJ y U M Q p wwef peo ou si 3194 181 ejns IYEN SS OOE JOJEQNOU v 9A0UJSH 2 3000 oop ssoooe juBu do pue 100p uonoe oo e1se y uedo uref osnom 301552204 9po Ipod J011 Sunposoag ABADI a qu 4940224 PUD ASVSSaP 40445 c g QPL The VITEK 2 User s Manual 8 62 Iowo uognq v uo pa1ojs uorjeutrogjur SULIOUSI sso20Jd IA 59 pur A ojerpouruir IN SSLI IY j2ar100 51 Sun S sty pue ATUO 9jjesssvo ur sr Ju ummnsur v JI ALON xn u lNolq Ile sunoeJ ue qoJd eu JI ueuinyjsur eui Olul n SE y uesur eH jueuinjjsul Z M3 LIA 24 episur sjoejuoo uouu8ui uoynq v ediw Udy pue diA ouoo e ue jno ezeenbs Au
74. Sta tion 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 VITEK 2 which marks the memory chip as being read allowing the cassette to be reused The VITEK 2 User s Manual 4 11 What Happens Inside VITEK 2 The VITEK 2 Instrument 4 12 O Cassette Base The base of a cassette is specially shaped to Fit snugly onto the base unit of the Smart Carrier Station When properly fitted on the base unit the contacts for the button memory are touching the contacts that protrude from the base unit Fit into a boat The shape of the cassette base matches the well on the top of a boat This ensures that the two units move as one through VITEK 2 The shape also ensures that the cassette can only be put into a boat in the proper orientation The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 Cassette Load and Unload Station You load and unload cassettes from VITEK 2 using this station As seen in the picture the station consists of the cassette load door and a green indicator light The door has a locking mecha nism If the Indicator Light is Then On Off Blinking The VITEK 2 User s Manual The cassette load door is unlocked You may open the door to load cassettes The
75. TEK 2 Instrument Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Disposables Chapter 6 Processing VITEK 2 Test Cards introduced the Sta tus screen and how to incorporate it into your work flow A spe cific part of that screen is devoted to the maintenance of the VITEK 2 disposables Status OK MAX Available Slots 60 Cassette Name NSB Dilution Mode Automatic Tips Saline Figure 7 1 The VITEK 2 Status Screen Monitoring the Disposables Note the two bar graphs at the bottom of the screen Graph displays the current level of pipette tips that remain in the instrument Graph displays the level of saline that remains in the instrument The VITEK 2 User s Manual 7 3 Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument 74 INTERPRETING THE GRAPHS As the two disposables are used the shaded portion of the graphs moves to the left At the same time the value inside the graph decreases correspondingly The graphs are marked to show full 330 three quarter 248 one half 165 and one quarter 83 capacity If the level of either disposable drops below 40 the value changes to LOW What do these numbers mean and how should you use them The graphs and their values refer specifically to the number of antimicrobial susceptibility tests AST that can be processed This means that the graphs and values are important only when you are processing ASTS in the Automati
76. TY ERROR 1 Press the Error Message key to display the error message queue For a card capacity error you see the following screen Message Queue Processing Warning Insufficient slots to process this cassette Message 1 of 1 12 00 131 Figure 8 8 Card Capacity Warning Message 2 Open the Cassette Load door and remove the cas sette You can remove a number of test cards from the cassette to resolve this type of error However there is another option available because it takes several minutes for a cas sette to reach the Reader station During this time addi tional carousel slots can be made available by ejecting cards whose tests have finalized Continue the procedure as follows The VITEK 2 User s Manual 8 27 Cassette Load Processing Errors Troubleshooting the VITEK 2 Instrument 3 Consult the card directory at the workstation Count the number of cards whose tests have finalized and that can be ejected 4 Ejectthose cards using the workstation software 5 lfthere are still too many test cards in the current cassette and remove the needed number of cards 6 Place the cassette back into the Cassette Load Unload Station and close the door This restarts the processing cycle for the cassette NOTE If the instrument s card capacity is exceeded the extra test cards are not processed and will be unusable 8 28 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Cass
77. UK Limited Grafton way Basingstoke Hampshire RG22 6HY tel 44 1256 461881 fax 44 1256 816863 USA bioM rieux Inc Box 15969 Durham North Carolina 27704 0969 tel 1 800 682 2666 This publication is based on software version VT2 R03 01 Updates are made periodically to this document Software revisions and other changes will be included in subsequent versions Copyright 2002 by 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 human or computer lan guage in any form or by any means whatsoever without the express written permission of bioM rieux Inc WARRANTY Seller bioM rieux Inc warrants the VITEK 2 instrument the instrument to the original purchaser for a period of one 1 year after date of installation against defects in material and workmanship and defects arising from failure to conform to specifications applicable on the date of installation Seller further agrees to correct either by repair or at its election by replacement any such defect found on examination to have oc curred under normal use and service during such one 1 year period provided Seller is promptly notified in writing upon discovery of such defect Seller shall not be liable under this Warranty for any defect arising from abuse of the system failure to operate and maintain the system in accordance with the docu
78. VI OUS SCREEN key returns the display to the previous menu If the Main menu displays on the screen pressing the PREVIOUS SCREEN key returns the display to the Sta tus screen About the Smart Carrier Station Advantages of Using the Smart Carrier Station The Smart Carrier System is a labor saving device that provides several advantages for your laboratory work flow Bar Code Scanner The bar code scanner allows you to uti lize the bar codes that are printed on the test cards and the SCS Job Aid card The Test Card Type Organism Ancil lary Test and Modifier fields can be entered without having to use the keyboard If your laboratory uses bar codes for accession number of specimens these can also be entered using the scanner The VITEK 2 User s Manual 6 13 About the Smart Carrier Station Processing VITEK 2 Test Cards Cassette The cassette helps you organize your work Each cassette has 15 slots for test cards and 15 corresponding wells for specimen test tubes Information entry using the SCS bar code scanner or keyboard is organized by slot which allows you to create a simple work flow For exam ple using the bar code scanner you could scan the accession ID place specimen test tube in its well Scan the test card place it in the corresponding slot scan the Job Aid card for optional fields such as organ ism ancillary tests or modifiers Matching ID and AST Cards When the SCS computer sees
79. VITEK 2 User s Manual 6 9 Introduction Processing VITEK 2 Test Cards About the VITEK 2 Menu System All of the functions used on the VITEK 2 instrument are avail able through the menu system The system is composed of a Main Menu and a set of five submenus Display Instrument QC Status Cassette Setup Batch Load Utilities Resolve Bar Code Errors Figure 6 3 VITEK 2 Main Menu In Figure 6 4 on page 6 11 the menu structure is shown with all of the function options added The bold lines in this figure show the menus and the pathways between them 6 10 The VITEK 2 User s Manual Introduction Processing VITEK 2 Test Cards Wain nua c MALIA 21 Jo 24njonajg pajivjaq p 9 24n814 senuoo S UIPEN u r s y sse eum oA l rqeuq uueTy eum oA e qeuq lopeos IPON pol4 sme OO IULEN JOLY TENSIA o qrpny UI o qrpn y opo seg uonnriq m sse o npouogs juoumusug nuon UOUBIDZUUO Surueo sondo Suruv y psnowp gurueo wog oyu UOISIOA myesodur nuo Surueo Zo qon diq 11045 11 sesso 1esuedsiq
80. abo ratory personnel should take the usual precautions necessary for infectious agents Before you load a cassette you should always check the Status screen Look at the following parameters to make sure it is okay to load the cassette Parameter What to Look For Status This field should read OK MAX Avail The value in this field should be greater able Slots than or equal to the number of test cards you are loading Available ID The value in this field should be greater Slots VITEK 2 than or equal to the number of identification XL only test cards you are loading Tips and Saline The level of both disposables should be greater than or equal to the number of test cards you are loading NOTE This parameter may be ignored if you are operating in the manual dilution mode Cassette Name The name of the previously used cassette is shown and will be applied to this cassette unless you change it Dilution Mode Make sure that the mode displayed matches the way in which you are processing the test cards 6 44 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards in Cassette Only Mode USING THE CASSETTE LOAD STATION The Cassette Load station shown below is composed of the cas sette load door and a green indicator light The indicator light shown in the figure above tells you the sta tus of the load station as follows P inr ee It Mea
81. acdod ejesseo y speal SOS eui J UOnels 2 yews u uo ejep y Jejue oJ pue 55 2 y uo 4oul uu uollnq y eoej dau niss ns JOU 1115 j 98 7 eGed uo seunpeooud y u deis ees SOS u uo H SSE y eoejd pue aoujeui uollnq y uo S19E1U02 eui ueej enesseo eui peas jouueo SOS J eyesseo eui pees ULI 1 jeui H A pue SOS eui UO YOR H SSE eui uonisod 4991109 51 epou eui J OPO Jame ueuis ui si jueuunjjsul eu 181 uujuo ueuinJjsul BU enesseo eui peolun D L myrey JOUIOUI uoyNg 979ss 3u02 SUISSODOIg Ipod 10117 a qu 4940224 PUD ASVSSaP 40445 c g QPL 8 63 The VITEK 2 User s Manual xn u lNolq Ile sunoeJ ue qoJd eui S xn u lNolq Ile senunuoo uiejqoud eui J 9g g eBed uo einpeooud y 89S s onsouBeip 101edig 1esuedsiq eui uaopeg 4AOSS OOE Meu e ejsul pepeeu J Z 8010 3 oures oq ur s yourd 10 so guv 884 OY ur ur es jo Kjguenb juororgns E 9 7 o8ed uo ounpoooud uorv eisur Wy ATOSS V 99S Wy K10ssoooe oy Jo uone ejsur 1odoud guo 498uo pue JOOP sseooe 1u0Jj v uedQo amey 1osuodsiq 80155920 gpod 1011 sap q 4194093931 ATepuo s
82. aced into test tube slots 2 4 and 5 NOTE This cassette does NOT require the use of the Smart Carrier Station 2 Access the Dispenser Pipettor diagnostic test using the path Main Menu gt Utilities Diagnostics Dispenser Pipet tor 8 36 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Instrument Diagnostics The following message displays About to perform dispenser pipettor test Do you wish to continue 3 Press the Yes option button A message on the display will instruct you to load the cas sette that you prepared in step 1 4 Open the Cassette Load door load the cassette and close the Cassette Load door 5 While the instrument is performing this test open the front door of the instrument and visually check the saline dispenser for any of the abnormal conditions listed below Look for repeated back and forth movement while the saline dispenser is in the upright position The saline dispenser tube should move smoothly up and down when filling each AST tube The VITEK 2 User s Manual 8 37 Instrument Diagnostics Troubleshooting the VITEK 2 Instrument Look for saline remaining in the saline dispenser tube when it returns to the upright position Look for a saline stream and or drops released from the saline dispenser tube when it is filling with saline Look for a saline stream and or drops released from the saline dispenser tube as it returns to the upright positi
83. address which appears in the VITEK 2 Directory window at the workstation provides a means to identify each test card in the VITEK 2 instrument The following figure illus trates two examples Figure 6 10 The Cassette Address A cassette address has three basic parts Using the first example from Figure 6 10 the following table shows what each of these parts mean and how they are derived The Cassette For staan from Address Section example s The cassette RMT The three character cas name sette name that is entered in the Cassette Names function The slot position 03 The actual test card posi 1 15 of the tion in the cassette as read test card in the by the VTTEK 2 bar code cassette reader Date time stamp Apr 03 The date and time the test 08 35 40 card was read by the VITEK 2 bar code reader The cassette name portion of the address can represent various laboratory parameters such as a technologist s initials a speci men source or a work shift The VITEK 2 User s Manual 6 49 Batch Loads Smart Carrier or Cassette Only Mode Processing VITEK 2 Test Cards Batch Loads Smart Carrier or Cassette Only Mode How to Select Batch Loading Batches of three or four cassettes can be loaded in rapid succes sion using the Batch Load function BEFORE YOU BEGIN Because a batch load requires most or all of VITEK 2 s resources you should do the following before initiating a batch load 1 Batc
84. after replac ing the boat Press here after completion The first screen reappears with the boat count at 1 of 4 6 Repeat this procedure starting at step 2 until all four boats have been replaced 7 Press the Previous Screen key il Z when the display shows Current number of Boats 4 of 4 The VITEK 2 User s Manual 7 45 Cleaning the Inside of the VITEK 2 Instrument Maintaining the VITEK 2 Instrument Cleaning the Inside of the VITEK 2 Instrument DANGER All organism suspensions should be considered as poten tially infectious Qualified laboratory personnel should use AN acceptable procedures for biohazardous material NOTE The procedures in this section should be performed monthly or as conditions require Shutting Down the VITEK 2 Instrument DANGER There are elevated temperatures and hot surfaces inside the instrument Shut down the instrument before starting the N cleaning or any other procedures inside the instrument NOTE Finish processing all cards before beginning this pro cedure 1 Access the Shut Down function using the path Main Menu gt Utilities Maintenance Shut Down 7 46 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Inside of the VITEK 2 Instrument If any cards are processing the instrument displays this screen Cards are currently processing Do you wish to continue Yes No CAUTION
85. al Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors 3 Press the F3 key to display the Summary screen 4 Checkthe positions and the types of test cards against the data displayed on the screen 5 Move the test cards and their dilution tubes as nec essary to match the data on the screen 6 Place the cassette back into the Cassette Load sta tion and close the door This restarts the processing cycle for the cassette The VITEK 2 User s Manual 8 23 Cassette Load Processing Errors Troubleshooting the VITEK 2 Instrument Inoculum Errors When VITEK 2 is operating in the Automatic dilution mode every susceptibility test card must be provided with an inocu Ium source The inoculum must be placed in the slot that immediately precedes the susceptibility card It can be placed next to an empty slot or a slot containing a matching identifi cation card During the bar code read the instrument checks for one of these two conditions If the instrument detects an inocu lum error e The cassette is backed out to the Cassette Load station The error alarm is activated 1 For gram negative test cards the inoculum can be followed by one or two susceptibility cards 2 A matching identification card is one having the same accession ID and test type gram gram as the susceptibility card The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors
86. all an accessory kit The VITEK 2 User s Manual 7 5 Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument How to Install an Accessory Kit Part A Saline and Tubing NOTE If the card transport system is processing cassettes through the card transport station the following mes sage appears Card transport system is busy Please try later CAUTION Use aseptic technique when installing an accessory kit AN 1 Access the Change Saline function using the path Main Menu gt Utilities Maintenance gt Change Saline The following prompt appears Change Saline About to change saline Do you wish to continue 7 6 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables 2 Press the Yes option button to continue with the saline change After you proceed the instrument displays the next prompt to which you should respond after the saline change is completed Change Saline Proceed with saline change Done Cancel The VITEK 2 User s Manual Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument 3 Open the front access door see left figure below to expose the dispenser station then lift the saline access door to expose the saline bag 4 Pull on the filter disk see right figure above to remov
87. and follow the recovery procedure The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument The Error Handling System The Error Alarms CAUTION A VITEK 2 has two alarms to alert you to the presence of an error condition The dual alarms are provided in case the VITEK 2 instrument and the workstation are in different locations When they are in close proximity the audible alarm on the instrument can be disabled as a configuration option e Audible alarm This alarm sounds both at the VITEK 2 instrument and at the workstation Another instrument configuration option allows you to set the volume of the audible alarm e Visual alarm This alarm uses the screen on the interface display When the visual alarm is activated the screen flashes to indicate the pres ence of an error condition An instrument configuration option allows you to disable the visual alarm Do not disable both the audible and the visual alarms Doing so eliminates all indicators of an error condition which could result in the termination of tests in progress The VITEK 2 User s Manual 8 5 The Error Handling System Troubleshooting the VITEK 2 Instrument Types of Errors There are three basic types of errors those that cause the Reader or Card Transport system to halt those that do not cause the Reader or Card Transport system to halt errors that occur when you load a new cassette NOTE All errors messages are logged in the Er
88. appropriate box The row of boxes is filled in as data is entered These boxes are empty unless the user has entered data previously A box in the row is filled automatically when the user enters data into the Card Type field Indicators are I gram positive ID I gram negative ID IA anaerobe ID IY yeast ID S gram positive susceptibility S gram negative susceptibility X Indicates the position of the inoculum tube for a susceptibility test without a pre ceding mated ID when in automatic dilu tion mode This slot must not contain a card Table 6 2 6 18 Smart Carrier Station Data Fields The VITEK 2 User s Manual Processing VITEK 2 Test Cards About the Smart Carrier Station Using the Slot Indicator A filled in circle appears under a box when the SCS determines the test card in the slot requires an organism sus pension A completely open circle O appears under a box when the test card in the slot requires an empty tube Empty tubes are used for AST cards when the SCS is set to Auto matic dilution mode SCS Functions The following table summarizes the functions that can be per formed while entering data and the use of the special function keys 1 To Do this keys Display context sen 1 Press the key sitive help screens and data field option boxes Move between fields Press the UP DOWN or LEFT RIGHT ARROW keys Access the Isolate Pre
89. as cycled the screen below displays automatically Carousel Cleaning Preparing for Section Replacement Continue Cancel 1 The VITEK 2 User s Manual 7 29 How to Replace the Carousel After Cleaning Maintaining the VITEK 2 Instrument 2 Press Continue to continue with the carousel replacement The following screen displays Carousel Cleaning Remove the incubator access cover now 3 Remove the incubator access cover When the access cover has been removed the following screen displays Carousel Cleaning Preparing for section replacement 7 30 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument How to Replace the Carousel After Cleaning When the carousel is in position the following screen dis plays Carousel Cleaning Replace Section Now Current number of Sections 0 of 4 Press here after completion 4 Take any one of the carousel sections and orient it as shown in the following figure The bottom of the section should be touching the base plate and the top portion should be tilted slightly toward the front of the instrument The VITEK 2 User s Manual 7 31 How to Replace the Carousel After Cleaning 5 Maintaining the VITEK 2 Instrument Slide the section down along the base plate while maintaining the tilted angle
90. been entered at the SCS the cassette is ready to be loaded into the VITEK 2 instrument Before you load the cassette however you should always check the Status screen Look at the following parameters to make sure it is okay to load the cassette Parameter What to Look For Status This field should read OK Available Slots The value in this field should be greater than or equal to the number of test cards you are loading Tips and Saline The level of both disposables should be greater than or equal to the number of test cards you are loading NOTE This parameter may be ignored if you are operating in the Pre diluted mode Cassette Mode This field should read SCS Smart Car rier Station The VITEK 2 User s Manual 6 31 Processing Test Cards Using the Smart Carrier Station Processing VITEK 2 Test Cards USING THE CASSETTE LOAD STATION The Cassette Load station is composed of the cassette load door and a green indicator light The indicator light tells you the sta tus of the load station as follows If the Indicator It Means that Light is On The cassette load door is unlocked You may open the door to load cassettes Off The cassette load door is locked and cannot be opened Blinking A boat with an empty cassette has arrived at the station You should open the cassette load door and remove the cassette When the door is closed again the blinking stops Tabl
91. ble 8 1 Record the weight of the tube in slot 1 in the Pipettor Low Volume section Test tube 1 Before test B Record the weight of the tube in slot 3 in the Pipettor High Volume section Test tube 3 Before test B Record the weight of the tube in slot 5 in the Diluter section Test tube 5 Before test B The VITEK 2 User s Manual 8 39 Instrument Diagnostics Troubleshooting the VITEK 2 Instrument Use this table to record the weights of your test tubes Make one copy for your use and keep the original in this manual Pipettor Low Volume Results Date Tested Performed By Test tube 1 Before test B Test tube 1 After test A Weight of 1 B 1 A Acceptable range 095 gm to 105 gm Pipettor High Volume Test tube 3 Before test B Test tube 3 After test A Weight of 3 B 3 A Acceptable range 285 gm to 315 gm Diluter Test tube 5 Before test B Test tube 5 After test A Weight of 5 A 5 B Acceptable range 2 33 gm to 2 63 gm Table 8 1 Dispenser Pipettor Volumetric Test 8 40 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Instrument Diagnostics 3 Access the Dispenser Pipettor diagnostic test using the path Main Menu gt Utilities gt Diagnostics gt Dispenser Pipettor The following message displays About to perform dispenser pipettor test Do y
92. c Dilution mode that is when the VITEK 2 instrument is performing the dilution of the AST inoculums For example when one of the graphs is at one half capacity it means that enough of that disposable remains to process approximately 160 AS Ts The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables USING THE GRAPHS The best way to use the graphs is to periodically compare the levels of the graphs to the number of ASTs you anticipate dur ing a period If the disposables level is lower than the antici pated work load install an accessory kit before you begin see following sections In this way your work flow will not be interrupted during test card processing When comparing the disposables level to your work load it is important to remember that the graphs are APPROXIMATIONS of the actual level of disposables EXPIRATION OF DISPOSABLES VITEK 2 is programmed to measure the amount of time that the disposables have been in the instrument When the specified time limit is exceeded VITEK 2 displays an error message tell ing you that a disposable has expired The Dispenser Pipettor Accessory Kit If the disposables have reached a low level or if they have expired you need to install a Dispenser Pipettor Accessory Kit The kit consists of a container of pipette tips and a saline dis penser tube with its associated tubing The following two sec tions in this chapter describe how to inst
93. cassette load door is locked and cannot be opened A boat with an empty cassette has arrived at the station The cassette load door is unlocked You should open the door and remove the cassette When the door is closed again the blinking stops 4 13 What Happens Inside VITEK 2 The VITEK 2 Instrument CAUTION The VITEK 2 test card transport system stops while the cas sette load door is open Be sure to close the door after load K ing or unloading a cassette DANGER The boat should be considered as potentially contaminated and should be handled appropriately Qualified laboratory A personnel should take the usual precautions necessary for infectious agents CAUTION Do not move or remove a boat from the instrument unless you are using the programmed function for this purpose 4 N Doing so can cause an instrument jam See the procedure for removing boats on page 7 39 4 14 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 The Boats VITEK 2 contains four plastic trays called boats They are called boats because they carry a cassette through the various processing stations inside VITEK 2 A Boat shown in the figure above has particular features that support its three major functions Test Card Transport top surface of a boat forms a specially shaped well into which a cassette is placed The shape of the well conforms to the base of a cassette providing it
94. ccur inside the VITEK 2 instrument if the Dilution Mode option is not properly set This is especially true if pre diluted samples are used with the mode set to Auto matic Page 5 12 Biohazardous spills can occur inside the VITEK 2 instrument if the Dilution Mode option is not properly set especially if pre diluted samples are used with the mode set to Automatic AII organism suspensions should be considered as potentially infec tious Qualified laboratory personnel should use acceptable pro cedures for biohazardous material Page 6 7 and 6 43 The cassette should be considered as potentially contaminated and should be handled appropriately Qualified laboratory per sonnel should take the usual precautions necessary for infec tious agents Page 6 31 and 6 44 Do not attempt to load a cassette if a boat is not at the station Damage to the cassette and the VITEK 2 instrument is possible Page 6 33 and 6 46 All of the materials in an empty cassette should be treated as biohazards and disposed of accordingly All organism suspen sions should be considered as potentially infectious Qualified laboratory personnel should use acceptable procedures for bio hazardous material Page 6 56 Although VITEK 2 test cards are sealed they should be treated as biohazards and disposed of accordingly Page 6 58 The VITEK 2 User s Manual xxiii Warning Messages xxiv The carousel should be considered as potentially contaminated and
95. ct the firmware you need How TO USE THIS OPTION You receive periodic program updates along with installation instructions for these updates from bioM rieux Once you per form an update all the necessary SCS files are included in the workstation NOTE Make sure the SCS is connected to the workstation 1 Press the F4 key to access the Configuration screen 2 Press the NEXT or PREVIOUS SCREEN key until the Firmware Update Options screen displays The VITEK 2 User s Manual 3 0 Why and How to Set the Options Configuring the Smart Carrier Station 3 Press the DOWN ARROW key to move the cursor to the option specified in the update instructions 4 Press the ENTER key to select the option The fol lowing message appears Press F1 to start selected function any other key to cancel 5 Press the F1 key 6 Update Specific File only Enter the file name specified in the update instructions The following message appears Press F1 to start transfer 7 Press the F1 key to begin the update Cassette Erase The Cassette Erase function gives you the option of automati cally erasing data in the button memory of cassettes that have been processed by the VITEK 2 How TO SET THIS OPTION 1 Press the F4 key to access the Configuration screen 2 Press the NEXT or PREVIOUS SCREEN key to access the Cassette Erase screen There are two settings available Automatic and Verify First Select Automatic to automatically era
96. d Resolve the problem as indicated in Table 8 2 The VITEK 2 User s Manual 8 11 The Error Handling System Troubleshooting the VITEK 2 Instrument Reviewing an Instrument Halted Screen 1 Press the Error Message key to view the error mes sage queue NOTE If there is more than one message use the DOWN ARROW to review and address each message 2 Lookup the Primary Error Code and then the Sec ondary Error Code in the section How to Use Error Message and Recovery Table on page 8 55 in this chap ter If an error recovery procedure is given follow its directions then continue with Step 3 3 Press the PREVIOUS SCREEN key to exit the error message queue and return to the Halted screen 4 Press GO to resume processing NOTE If the recovery procedure was successful the Status screen appears with a Status of OK If the Instrument Halted screen reappears record the error code number and call bioM rieux 8 12 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument The Error Handling System Reviewing a Status Screen with Messages 1 Press the Error Message key to view the error mes sage queue NOTE If there is more than one message use the DOWN ARROW to review and address each message 2 Look up the Primary Error Code and then the Sec ondary Error Code in Table 8 2 If an error recovery procedure is given follow its directions then con tinue with Step 3 3 Press the PREVIOUS SCREEN key to
97. date is transferred to the workstation which prints it on the laboratory report Test Card lot information and a sequence number This includes the test card s lot number to provide manufacturing traceability The sequence number uniquely identifies a test card CAUTION When handling VITEK 2 test cards make sure you do not deface bar code in any way 4 16 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 CAUTION See Laser Caution statement on page xviii A The Button Memory Reader The Button Memory Reader is a device that VITEK 2 uses to read the test card information stored by the Smart Carrier Sta tion in the memory chip on a cassette VITEK 2 uses this test card information in two ways The test card type entered at the SCS is compared to the test card type that VITEK 2 reads with its own bar code reader This ensures that no changes were made in the position of any test card in the cassette The accession ID test card type and the other fields entered at the SCS are sent to the computer This information allows the software to link the test card results from VITEK 2 to patient demographic data and any previous test results After the information is extracted from the button memory VITEK 2 marks its contents as having been read When the cas sette is put on the SCS again a button memory marked as read is erased so that the cassette can be used again CAUTION T
98. dex finger of one hand on the sliding retainer bar to prevent it from snapping back The VITEK 2 User s Manual 6 57 Unloading the Cassette and Removing Waste Processing VITEK 2 Test Cards DANGER AN 6 58 3 Remove the waste collection tray from the sta tion by lifting the front edge of the tray slightly and then pulling it toward you 4 When the tray is clear of the station allow the slid ing retainer bar to slowly slide back into place 5 Dispose of the test cards in the tray NOTE Once cards have been removed from the Waste Collec tion station never reinsert them This will cause the instrument to jam Although VITEK 2 test cards are sealed they should be treated as biohazards and disposed of accordingly REPLACING THE WASTE COLLECTION TRAY 6 Slide the tray onto its shelf lifting the front edge to clear the retaining brackets 7 Close the waste collection door NOTE If the waste collection tray is not replaced the instru ment cannot eject cards and eventually stops process ing The VITEK 2 User s Manual T Maintaining the VITEK 2 Instrument Introduction This chapter includes the procedures required to maintain the VITEK 2 instrument Maintenance includes monitoring and changing the disposables cleaning the boats and the carousel and general maintenance and cleaning NOTE The Maintenance Log provided at the end of this Where to Find It chapter lists recommended maintenanc
99. e and then press ENTER 5 Press the F2 key to exit the SCS Configuration screen or the NEXT or PREVIOUS SCREEN keys to access other configuration screens The VITEK 2 User s Manual 3 7 Why and How to Set the Options Configuring the Smart Carrier Station Time and Date The SCS tracks the time of day and the calendar date How TO SET THESE OPTIONS 1 2 3 8 Press the F4 key to access the Configuration screen Press the DOWN ARROW key to move the cursor to the Time field In the Hour field enter the current hour using a 24 hour format i e 9 p m 2100 Press the ENTER key to accept the new value Enter the current minutes Press the ENTER key to accept the new value Enter the current day Press the ENTER key to accept the new value Enter the current month The VITEK 2 User s Manual Configuring the Smart Carrier Station Why and How to Set the Options 10 Press the ENTER key to accept the new value 11 Enter the current four digit year 12 Press the ENTER key to accept the new value 13 Press the F2 key to exit the SCS Configuration screen or the NEXT or PREVIOUS SCREEN keys to access other configuration screens Firmware Update Options The SCS firmware can be updated to enhance its functions These updates are performed by connecting the SCS to the workstation using a cable Since you may need to update only a portion of the SCS firmware the Program Updates options allow you to sele
100. e entire instrument do not replace the boats until after you clean the base pan Refer to the procedure on page 7 53 7 42 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Boats 1 Access the Boat Cleaning function using the path Main Menu gt Utilities gt Maintenance gt Cleaning Boat Cleaning The following prompts appear Boat Cleaning Current number of Boats 0 of 4 Replace Boat 2 Press the Replace Boat option button If there are boats in the card transport system and it is not idle the instrument displays the message Card transport system is busy Please try later The VITEK 2 User s Manual 7 43 Cleaning the Boats Maintaining the VITEK 2 Instrument 3 Ifthe system is idle the instrument prepares for the boat replacement and then displays this prompt Boat Cleaning Replace Boat Press here after completion Cancel 4 Open the front access door and replace the boat below the Pipettor station NOTE Boats must NOT be replaced at the Cassette Load Unload Station NOTE Make sure that the front legs 69 of the boat are positioned in the channel of the base pan the boat is oriented with the arrow 6 pointing toward the back 7 44 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Boats 5 Press the option button shown below
101. e 6 4 Interpreting the Cassette Load Station Indicator Light Before you attempt to load a cassette make sure the indicator light is on or is blinking The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards Using the Smart Carrier Station How TO LOAD A CASSETTE 1 Openthe Cas sette Load sta tion by lifting the cassette load door up There should be an empty boat at the station or one with a cas sette that contains waste A DANGER Do not attempt to load a cassette if a boat is not at the sta tion Damage to the cassette and the VITEK 2 instrument is K possible 2 Place the cassette in the boat so that the specimen test tubes face the front of the instrument NOTE The boat is shaped such that it will only accept a cassette in the proper ori entation The VITEK 2 User s Manual 6 33 Processing Test Cards Using the Smart Carrier Station Processing VITEK 2 Test Cards CAUTION To avoid possible processing errors make sure that all the test cards and test tubes are properly seated in the cassette 3 Close the cassette load door The cassette icon appears on the Status screen 4 Monitor the instrument until the cassette icon disap pears and the boat moves forward to process cards MONITORING CARD PROCESSING After a cassette is loaded the test cards in it are scanned by the bar code reader in VITEK 2 This information is sent to the workstation so that
102. e difficult to know that an error condition exists Page 5 15 The disposable monitors should be used as an approximate indi cator Care should be used to prevent running out of either dis posable during test card processing Page 6 9 To avoid possible processing errors make sure that all the test cards and test tubes are properly seated in the cassette Page 6 34 Leaving the door to the Cassette Unload station open will inter fere with the proper processing of the test cards in the VITEK 2 instrument Page 6 56 Use aseptic technique when installing an accessory kit Page 7 6 and 7 14 To prevent possible contamination of the saline use aseptic technique when handling the saline dispenser tube Page 7 9 To avoid contaminating new pipette tips do not touch the inside of the pipette container Page 7 16 The VITEK 2 User s Manual Warning Messages The exposed ends 6 of the pipette tips are the ones that come in contact with your specimens Appropriate precautions to pre vent contamination during this procedure are advised Page 7 18 Dishwasher temperatures during the washing and drying cycles must not exceed 85 C 185 F Exceeding this temperature will cause damage to the carousel sections Use the top rack of the dishwasher Page 7 28 7 35 7 42 7 49 and 7 58 If you select Yes to continue the cards being processed will be TERMINATED Page 7 47 Do not wear powdered latex gloves while cleaning the fluores
103. e displacement pump assembly extends a hollow metal tube into the container attaches a pipette tip to the tube and withdraws the pipette tip from the container The instrument checks to make sure that a pipette tip is attached 3 The pump assembly rotates so that the pipette tip is over the ID suspension test tube The pipette tip is then lowered into the suspension The instrument checks to make sure there is fluid in the ID test tube 4 The pump draws the preprogrammed amount of suspension and withdraws the pipette tip from the test tube 5 Thecassette moves so that the susceptibility test tube is now under the pipette tip 6 The pipette tip is lowered into the test tube and the pump dispenses the suspension into the tube where it mixes with the saline from the Dispenser 7 The pipette tip is removed from its attachment and left in the sample tube for disposal The VITEK 2 User s Manual 4 21 What Happens Inside VITEK 2 The VITEK 2 Instrument The Filler Station At the Filler station all of the test cards in a cassette are inocu lated with the suspension contained in their corresponding test tubes How DOES FILLING WORK The Filler station uses a vacuum chamber and pump When the boat carrying a cassette reaches this station the top of the vac uum chamber is lowered onto the boat The boat therefore serves as the base of the vacuum chamber The following steps occur 1 The pump evacuates the air from the c
104. e it from its connector 5 While pushing the Dispenser Release button carefully pull the saline tube out of its housing 7 8 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables 6 The entire assembly is now disconnected Since they are Single Use Only items you must discard the saline tube its tubing and the saline bag NOTE Since the saline dispenser tube does not come in con tact with any specimen it is not considered a biohaz ard Use normal laboratory precautions when disposing of this assembly CAUTION To prevent possible contamination of the saline use aseptic technique when handling the saline dispenser tube 7 Remove a new bag of 0 45 sterile saline from its protective pouch 8 Remove a new tubing assembly from its container The VITEK 2 User s Manual 7 9 Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument 9 Remove the covers from the large port of the saline bag and from the bag spike of the tubing assembly 10 Insert the bag spike from the tubing assembly into the port 9 of the saline bag 11 Place the new bag of saline on its shelf on the top of the instrument 12 While pushing the release button see figure at right insert the saline dispenser tube into its housing After the tube is fully inserted release the button NOTE Make sure that the saline dispenser tube is firmly seat
105. e procedures and their frequency Please make one copy for your use and keep the original with this manual Maintaining the VITEK 2 Disposables 7 3 Monitoring the Disposables 7 3 The Dispenser Pipettor Accessory Kit 7 5 How to Install an Accessory Kit Part A Saline and Tub ing 7 6 How to Install an Accessory Kit Part B Pipette Tips 7 14 Cleaning the Carousel 7 21 How to Remove the Carousel for Cleaning 7 21 How to Clean the Carousel 7 28 How to Replace the Carousel After Cleaning 7 29 The VITEK 2 User s Manual 7 1 Introduction 7 2 Maintaining the VITEK 2 Instrument Cleaning the Cassettes 7 34 How to Clean the Cassettes 7 34 Cleaning the Boats 7 39 How to Remove Boats for Cleaning 7 39 How to Clean the Boats 7 42 How to Replace Boats after Cleaning 7 42 Cleaning the Inside of the VITEK 2 Instrument 7 46 Shutting Down the VITEK 2 Instrument 7 46 Cleaning the Test Card Collection Tray 7 49 Cleaning the Optics Normal Maintenance 7 50 Cleaning the Base Pan Vacuum Seal and Vacuum Chamber 7 53 Cleaning the Drip Pan 7 56 Removing the Drip Pan 7 57 How to Clean the Drip Pan 7 58 Replacing the Drip Pan 7 58 Turning the Instrument On 7 59 Cleaning the Smart Carrier Station 7 60 How to Clean the Smart Carrier Station SCS 7 60 VITEK 2 Maintenance Log VITEK 2 XL Maintenance Log The VITEK 2 User s Manual Maintaining the VI
106. ed as potentially contami nated and should be handled appropriately Qualified labo A ratory personnel should take the usual precautions necessary for infectious agents If they are so equipped you must first remove the button mem ory module from the cassette If not proceed to Step 5 DANGER Exposing the button memory to the recommended cassette cleaning procedures can cause irreparable damage to the d unit 7 34 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Cassettes The cassette material is designed to withstand any of the fol lowing cleaning methods Automatic dishwasher with standard laboratory detergent CAUTION Dishwasher temperatures during the washing and drying cycles must not exceed 85 C 185 F Exceeding this tem K perature will cause damage to the cassettes Use the top rack of the dishwasher 10 bleach solution Phenolic cleaning solution NOTE To disinfect a contaminated surface use the 10 bleach solution and allow it to remain in contact with the contaminated surface for five minutes The VITEK 2 User s Manual 7 35 Cleaning the Cassettes Maintaining the VITEK 2 Instrument 1 Turn an empty cassette over so that its underside is facing you as shown in the figure below 2 Apply a slight inward pressure to the plastic tab 6 that extends from the memory module 6 3 Atthe same time pull the button mem ory module away from the cass
107. ed in the housing and that the tubing flows smoothly without any kinks or twisting 13 Grasp the filter disk 0 and firmly push it onto the connector located above the saline dispenser tube Avoid excessive pressure however as it could cause the filter to break 7 10 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables 14 Press the round plate 11 to allow saline to flow into the saline dispenser tube Do not allow the saline level to fill above the top inlet port 12 15 Release the plate 16 Close both the front access door and the 12 saline access door to the instrument The VITEK 2 User s Manual 7 11 Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument 17 Press the Done option button Change Saline Proceed with Saline change Done Cancel The following message appears Change Saline Performing Dispenser self test The self test checks for proper installation of the saline dis penser tube It is recommended that you wait for the test to complete about 20 seconds before leaving the instrument If the test is successful the Maintenance Menu displays If the test fails the message Saline Dispenser Tube installation error displays There is a problem with the saline dispenser tube installation Inspect the t
108. een Automatically displays at the end of the instrument s power up initialization process Automatically displays from the Main Menu whenever that menu is left unattended for more than one minute Displays from the Main Menu by pressing the PREVIOUS SCREEN key The VITEK 2 User s Manual 6 3 Introduction Processing VITEK 2 Test Cards INSTRUMENT STATUS FIELD The Status field appears at the top of the VITEK 2 Status screen Status OK MAX Available Slots 60 Cassette Name NSB O Dilution Mode Automatic Figure 6 1 The VITEK 2 Status Screen in Cassette Only Mode The Instrument Status field 9 displays one of the following OK This status means that all of the subsystems in the instrument are working normally and that the instrument is ready to accept test cards for processing Warming This status is seen after the instrument is turned on It means that the incubation temperature in the reader station has not reached its specified temperature Test cards cannot be processed until this status changes to OK 6 4 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Introduction Messages This status indicates that there is an error mes sage in the error message queue that has not been viewed Press the Message key to view the error message queue Errors This status appears after the error message queue is accessed if the error condition has not
109. een so that you can see the display 2 Connect the power cord to the back of the SCS 6 and the other end to an AC power outlet 3 Connect the SCS keyboard to its receptacle 6 on the back of the base unit 4 Connect the bar code scanner to its receptacle 9 on the back of the base unit The VITEK 2 User s Manual 2 7 Starting the Smart Carrier Station The Smart Carrier Station 5 Push the power switch to turn the unit on The computer takes a few moments to go through its start up routine 6 If nothing appears on the display use the contrast adjustment wheel to adjust the display once it has become active The following screen appears when the SCS is ready to use 09 15 25 bioM rieux Insert cassette to enter data Figure 2 1 Initial SCS Screen NOTE If you have not yet assigned a Station Name on the Configuration screen the Configuration screen appears rather than the one above For information on configuring the Station Name see the instructions on page 3 5 2 8 The VITEK 2 User s Manual 3 Configuring the Smart Carrier Station Introduction Configuration options allow you to operate the Smart Carrier Station in a number of different ways This chapter explains not only how to set these options but how each option affects the data stored in the button memory of a cassette Where To Find It Configuration Overview 3 2 When Should Configuration Options be Set
110. emperature 20 C to 50 C Pollution Degree 2 in accordance with IEC 664 Over voltage Category II per IEC 664 Electrical Characteristics Input Power 100 120 VAC 50 60 Hz 200 240 VAC 50 60 Hz Fused input current 2 amp T GDC 2 Nominal input current 2 amps 120 VAC amps 240 VAC Power 10 watts nominal Heat 34 BTU HR nominal Power Cord Detachable 3 wire g per IEC 227 or IEC 245 The VITEK 2 User s Manual Appendix 7 Glossary Access doors VITEK 2 VITEK 2 has six doors to enable the operator to access the internal systems and stations to replenish supplies and perform maintenance and cleaning procedures top access door saline access door front access door bottom access door cassette load and unload door and waste collection access door Access doors VITEK 2 XL VITEK 2 XL has nine doors to enable the operator to access the internal systems and stations to replenish supplies and perform maintenance and cleaning procedures top access door section A top access door section B saline access door front access door front center sliding door bottom access door cassette load and unload door and 2 waste collection access doors Accession ID The Accession ID is a unique identifier that associates a patient culture to a test card in the VITEK 2 system The Accession ID which can contain up to 20 alphanumeric characters is fol lowed by a dash and a single digit isolate number The VITEK
111. ents xxii Standard Symbols xxvii 1 How To Use This Manual OAM ZA ON noo bt r RS doe w S p d 1 1 Printed vs Online Documentation 1 2 How to Find Topics and Procedures 1 3 Typographic Conventions 1 4 2 The Smart Carrier Station Introductions Asser Le tie Ue AG M peu eR ad 2 1 Where to Find1t 2 1 What is the Smart Carrier Station 2 2 The SCS Base Unit 2 4 The CS Sereen oie s puasa p eT RES eo Sula ee EEG 2 5 The SCS Bar Code Scanner 2 5 The SCS Keyboard aces guru ERR 2 5 Starting the Smart Carrier Station 2 7 The VITEK 2 User s Manual vii Table of Contents 3 Configuring the Smart Carrier Station Introduction 3 1 Where To Find I 2 ol Se aqsu u ie 3 1 Configuration OvervieVV 3 2 When Should Configuration Options be Set 3 3 How do You Access the Configuration Screens 3 4 Why and How to Set the Options 3 4 AST Dilution Mode 3 4 Station Name 2 44 24 band dese p RR pasu aus Kee 3 5 Key Voserdus Tapu yu EXESM EXE 3 6 Language vie eu pa ced 2 et eee MES 3 7 andate ues etd ne dee RR be eae a 3 8 Firmware Update Option
112. er Date time stamp Apr 03 The date and time the test 08 35 40 card was read by the The VITEK 2 User s Manual VITEK 2 bar code reader Processing Test Cards in Cassette Only Mode Processing VITEK 2 Test Cards The cassette name portion of the address can represent various laboratory parameters such as a technologist s initials a speci men source or a work shift Processing Test Cards in Cassette Only Mode NOTE If your system has a Smart Carrier Station refer to the section Processing Test Cards Using the Smart Car rier Station on page 6 25 Configuration Options to Consider On the VITEK 2 instrument set the Cassette Mode option to Cassette Only Dilution Mode option to Automatic or Pre Diluted as appropriate NOTE The procedure for these options appears on page 5 24 6 36 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards in Cassette Only Mode The Work Flow The following table provides a generalized work flow for work ing without a Smart Carrier Station SCS This work flow assumes that you have selected the VITEK 2 test cards to process decided whether to prepare susceptibility suspensions man ually or automatically using VITEK 2 The VITEK 2 User s Manual 6 37 Processing Test Cards in Cassette Only Mode Processing VITEK 2 Test Cards NOTE If you choose to prepare suspensions manually sus pension preparation instructions can be found
113. er s Manual Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors SCS and Bar Code Reader Conflict This type of error only occurs when VITEK 2 is operating in Smart Carrier mode That is because the error is based on a comparison of the information read from the bar codes with that read from the cassette memory The card type is part of the information read on the bar code Therefore a card type error occurs if a test card type that is different from the one expected according to the cassette memory If the instrument detects a card type error The cassette Is backed out to the Cassette Load station The error alarm is activated The VITEK 2 User s Manual 8 21 Cassette Load Processing Errors Troubleshooting the VITEK 2 Instrument How TO RESOLVE A SCS AND BAR CODE READER CON FLICT 1 Press the Error Message key to display the error message queue For a card type error you see the follovving screen Message Queue Processing Error SCS and Bar Code Reader conflict at slot NN Message 1 of 1 12 00 4 31 Figure 8 6 Card Type Error Message 2 Open the Cassette Load station door and remove the cassette and place it on the SCS DANGER The cassette should be considered as potentially contami nated and should be handled appropriately Qualified labo ratory personnel should take the usual precautions XK necessary for infectious agents 8 22 The VITEK 2 User s Manu
114. es Workstation computer consisting of a monitor keyboard and mouse VITEK 2 instrument consisting of a keypad and screen Smart Carrier Station consisting of a keyboard and screen Waste collection station Once testing is complete cards are stacked in a tray for dis posal Glossary 10 The VITEK 2 User s Manual Glossary Workstation computer The workstation computer is the primary processor used in cal culating test results The workstation can also be used as a means to interface the VITEK 2 system with a central labora tory or hospital computer system The workstation computer provides the user with the graphical interface used with the mouse pointing device and workstation monitor and a text interface for the keyboard The VITEK 2 User s Manual Glossary 11 Index A Access doors 4 6 Accession ID field 6 16 Accessories kit 7 5 installing 7 6 7 20 Address cassette 6 35 6 40 Alarm audible 5 13 8 5 enabling 5 24 setting volume of 5 25 Alarm error 8 5 Alarm visual 5 15 8 5 enabling 5 24 Ancillary tests field 6 17 option box for 6 22 AST Card card matching with ID 6 14 dilution mode options 3 4 positioning in cassette 6 30 6 41 Audible alarm 5 13 enabling 5 24 setting volume of 5 25 Automatic QC report scheduling 5 22 B Bar code reader instrument 4 16 Bar code reader 5 12 enabling 5 24 load errors 8 17 working without 8 30 8 33 Bar code scanner SCS 2 5 6 13 6 24 Ba
115. es in the Organism Modifier table of the bioLIAISON data base Select Modifier Mod Mod Mod3 Mod4 Mod5 Mod6 How TO ENTER DATA USING AN OPTION BOX 1 Use the UP or DOWN ARROW key to move the cur sor into the correct field 2 Press the HELP key to access the option box for the field 3 Use the UP or DOWN ARROW key to move the selection pointer gt to the correct data entry 4 Ancillary Test only Press the or key to enter a positive or negative result respectively 5 Press the ENTER key to return to the data screen The VITEK 2 User s Manual 6 23 About the Smart Carrier Station Processing VITEK 2 Test Cards About the Bar Code Scanner The bar code scanner reduces the time required for data input If your laboratory uses bar codes to identify patient specimens these can be scanned to enter the accession ID The required bar codes for the Organism Ancillary Test and Modifier fields have been printed on the SCS Job Aid Card Bar code labels on every test card allow you to scan in the entry for the Card Type Field Additional information from this bar code is also stored in the button memory of the cas sette This information helps VITEK 2 properly identify and process each test The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards Using the Smart Carrier Station Processing Test Cards Using the Smart Carrier Station NOTE If your
116. est Danger A DANGER statement is used when a particular action may result in personal injury damage to the instru ment or create a biohazard The VITEK 2 User s Manual 1 5 2 The Smart Carrier Station Introduction Use this chapter to familiarize yourself with the Smart Carrier hardware In the following section What is the Smart Carrier Station there is an overview of the entire unit including a section on the advantages of using the Smart Carrier Station In the sections that follow we provide more detailed descriptions of particular parts of the station Where to Find It What is the Smart Carrier Station 2 2 The SCS Base Unit 2 4 The SCS Screen 2 5 The SCS Bar Code Scanner 2 5 The SCS Keyboard 2 5 Starting the Smart Carrier Station 2 7 The VITEK 2 User s Manual 2 1 What is the Smart Carrier Station The Smart Carrier Station What is the Smart Carrier Station The Smart Carrier Station SCS is a small computer dedicated to collecting information about test cards and specimens and for transferring that information to the VITEK 2 instrument The SCS shown in the figure below has four main compo nents 2 2 The VITEK 2 User s Manual The Smart Carrier Station What is the Smart Carrier Station See also page The SCS Base Unit The base of the SCS con 2 4 tains the computer There are connection ports on the back of the base for the keyboard and
117. ette Figure 7 4 Removing the Button Memory Module 4 Clean the metal contacts see figure at right on the module with an alco hol wipe 7 36 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Cassettes NOTE When cleaning multiple cassettes it is not necessary to match a button memory module to a particular cas sette The units are completely interchangeable 5 The cassettes should be thoroughly cleaned and dried before they are used again The VITEK 2 User s Manual 7 37 Cleaning the Cassettes Maintaining the VITEK 2 Instrument REPLACING THE BUTTON MEMORY MODULE 6 Tum the cassette over and hold it in your right hand 7 Hold the memory module by the extended tab in your right hand so that the two metal contacts 6 will line up with the two holes in the side of the cas sette Figure 7 5 Replacing the Button Memory Module 7 38 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Boats 8 Place the other end of the module against the hold ing bracket 6 and push the module towards the side of the cassette The module should snap into place Cleaning the Boats NOTE The procedures in this section should be performed monthly or as conditions require NOTE Do not replace the boats if you are going to clean the inside of the instrument using the procedures that begin on page 7 46 How to Remove
118. ette Load Processing Errors Disposables Errors When a cassette begins processing VITEK 2 calculates the quantity of disposables that will be needed If the calculated value exceeds the current level of a disposable cassette is backed out to the Cassette Load station The error alarm is activated How TO RESOLVE A DISPOSABLES ERROR 1 Press the Error Message key to display one of the following messages Tip Level Low or Saline Level Low 2 Open the Cassette Load door and remove the cas sette 3 Perform the procedure in Chapter 7 to install a new VITEK 2 accessory kit and saline bag 4 Place the cassette back into the Cassette Load Sta tion and close the door The VITEK 2 User s Manual 8 29 Working Without the VITEK 2 Bar Code Reader Troubleshooting the VITEK 2 Instrument Working Without the VITEK 2 Bar Code Reader A good reading of the test card bar code is required by the sys tem to know the card type and how to process it The primary method of entering these bar codes is the Bar Code Reader sta tion in the VITEK 2 instrument There are also two backup methods The bar code scanner on a Smart Carrier Station which is then transferred to VITEK 2 via the smart cassette Manually on the VITEK 2 interface keypad If the Bar Code Reader station fails one of the two backup methods could be used 8 30 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Working Without t
119. exit the error message queue and return to the Status screen NOTE If the recovery procedure was successful the Status screen appears with a Status of OK If a problem still exists either the word Errors will be displayed in the status field or the word Messages if a new message has been generated NOTE If a problem recurs contact bioM rieux The VITEK 2 User s Manual 8 13 The Error Handling System Troubleshooting the VITEK 2 Instrument Reviewing a Status Screen with Errors When the status of Messages has changed to Errors this indi cates one of two conditions The message was reviewed but not resolved Follow Steps 1 through 3 in the procedure for Reviewing a Status Screen with Messages NOTE If the recovery procedure was successful the Status screen appears with a Status of OK If the Instrument Halted screen reappears record the error code number and call bioM rieux The recovery procedure was not successful call bioM rieux The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors Cassette Load Processing Errors Cassette load processing errors are a special set of errors that occur immediately following the loading of a cassette You should be familiar with this type of error because They are often caused by problems that can be resolved quickly thereby preventing any interruption in your work flow They occur at predic
120. fall into the container from the pack Replace the pipette tip container on its base making sure that it is firmly seated There is a key pin on the side of the container that must mate with a slot on the container base NOTE If the container is not seated correctly you will not be able to rotate it back into position The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables 12 Rotate the container 90 in a clockwise direction making sure that it is fully seated in the down posi tion 13 Close both access doors 14 Press the Done option button Change Pipette Tips Proceed with adding pipette tips Done 4 Cancel The following message appears Change Pipette Tips Performing Pipettor Self test The VITEK 2 User s Manual 7 19 Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument The pipettor self test only checks the electric motors in the pipettor station If the motors pass the test no further message is displayed and you are done with the installation If a problem is found the message Pipette Tip installation error appears and you will need to call bioM rieux for assistance 15 Perform the Dispenser Pipettor diagnostic test described on page 8 36 to ensure that the pipettor station is functioning properly The VITEK 2 User s Manual Maintaini
121. ge Recording QC Report appears on the screen The VITEK 2 User s Manual 5 9 How Configuration Options Affect VITEK 2 Configuring the VITEK 2 Instrument Cassette Mode WHY USE THIS OPTION The instrument user interface contains a function with which you can manually record a QC Status You can set this option if you want the report recorded automatically For example you can have the report recorded at the same time every day How TO SET THIS OPTION The procedure for setting this option is How to Set Time for the QC Status on page 5 22 The Cassette Mode option tells the VITEK 2 instrument whether or not you use a Smart Carrier Station SCS and is critical to instrument operation The option enables or disables the instrument s Button Memory Reader a device that reads information stored in the button memory WHY USE THIS OPTION The Cassette Mode option defaults to Smart Carrier meaning that an SCS is being used Use this option to change the mode to Cassette Only if your laboratory does not have an SCS How TO SET THIS OPTION The procedure for setting this configuration option is How to Use Option Boxes on page 5 24 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How Configuration Options Affect VITEK 2 Dilution Mode The Dilution Mode option can be set to either Automatic or Pre diluted In the Automatic mode the Dispenser Pipettor station in the VITEK 2 instrument automatically prepares the in
122. h loading requires at least three cassettes so check your work load to make sure that you are pro cessing enough test cards 2 Check the Status screen to make sure that the number of available slots equals or exceeds the number of test cards that you are loading he quantities of tips and saline is sufficient for the number of test cards that you are loading 6 50 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Batch Loads Smart Carrier or Cassette Only Mode To Begin a Batch Load This process begins with the preparation of the cassettes Refer to one of the following two procedures The procedure for cassette preparation in Smart Carrier mode begins on page 6 25 The procedure for cassette preparation in Cassette Only mode begin on page 6 39 NOTE You must prepare all three or four of the cassettes to be included in the batch load before proceeding 1 Bring the cassettes to the VITEK 2 instrument 2 Access the Batch Load function on the Main Menu The VITEK 2 User s Manual 6 51 Batch Loads Smart Carrier or Cassette Only Mode Processing VITEK 2 Test Cards The VITEK 2 instrument checks to ensure that at least three boats are available and that there are no test cards currently in the card transport system It then displays the following screen Batch Load How many cassettes do you want to load 3 Cassettes 4 Cassettes
123. hamber This forces the air inside each test card to escape via the transfer tube and bubble up through the suspension The channels and wells inside of each test card are now at a vacuum 2 After a short period the vacuum is slowly released The increasing air pressure inside the chamber forces the sus pension in each test tube through the transfer tube and into the channels and wells of the test card Various temperature and air pressure sensors in the system monitor the inside of the vacuum chamber VITEK 2 ensures proper test card fills by monitoring these parameters throughout the entire cycle and controlling the rate at which the vacuum is drawn and released NOTE The seal on the vacuum chamber should be cleaned periodically See the maintenance schedules and pro cedures in chapter 7 of this manual 4 22 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 The Sealer Station DANGER A The sealer station contains a wire that is heated during the sealing operation Do not reach into the instrument during the sealing operation The Sealer station completes the functions inside VITEK 2 that prepare the test cards for incubation and reading This is accom plished by heat sealing the transfer tube that delivered inocu lum to the test card from its test tube This seals off the contents of the test card As the boat and cassette move through this station a heated wire comes in contact wi
124. he Button Memory chip must be removed from the cas K sette before cleaning the cassette The VITEK 2 User s Manual 4 17 What Happens Inside VITEK 2 The VITEK 2 Instrument VITEK 2 Dispenser Pipettor Station This station automatically prepares the organism dilution used for AST Antimicrobial Susceptibility Testing cards VITEK 2 provides a significant time savings by ensuring that mated ID and AST cards are processed from the same sample THE DISPENSER The dispenser system shown in the following figure delivers 2 5 ml of sterile saline into the test tube of each AST card in a cassette Sterile Saline The top of VITEK 2 has a compartment designed to hold a one liter bag of sterile saline 69 This is enough saline to process about 330 AST cards 48 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 Dispenser Assembly The dispenser assembly consists of a plastic dispensing chamber and two sections of plastic tubing One section of tubing 9 leads from the dispens ing chamber and is attached to the sterile saline bag The other section of tubing also leads from the dispensing chamber but is attached to an air pump It is fitted with a filter 8 to prevent any particulate contamination Electromechanical Components not shown The elec tromechanical components control how the system works 1 When an AST card is detected a valve opens to allow saline to travel from its bag
125. he VITEK 2 Bar Code Reader How to Enter Bar Codes Manually Failure of the Bar Code Reader station on the VITEK 2 instru ment would result in a bar code read error for every card pro cessed This can be avoided by disabling the station and then entering bar codes via the Smart Carrier Station or manually on the VITEK 2 keypad To DISABLE THE BAR CODE READER 1 Access the Bar Code Reader configuration option using the path Main Menu gt Utilities Configuration The Bar Code Reader screen appears Bar Code Reader JY Enabled t Disabled 2 Press the DOWN ARROW key to disable the bar code reader The VITEK 2 User s Manual 8 31 Working Without the VITEK 2 Bar Code Reader Troubleshooting the VITEK 2 Instrument TO ENTER BAR CODES MANUALLY 3 Access the Resolve Bar Code Errors option on the Main Menu The following screen appears Bar Code Slot 4 Using the numeric keypad enter the bar code from the bar code label Press the ENTER key to accept the entry Repeat this step for each test card in the cassette NOTE The bar code you enter may be longer than the space provided on the screen When this occurs the first portion of the bar code scrolls off the display and the symbol gt appears 8 32 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Instrument Diagnostics NOTE Press the ENTER key to bypass empty slots 5 Press the Done key
126. he carousel Release the retaining pin when the cover is in place Once you have replaced the incubator access cover the Cleaning menu appears For instructions on replacing the carousel see How to Replace the Carousel After Cleaning on page 7 29 The VITEK 2 User s Manual 7 27 How to Clean the Carousel Maintaining the VITEK 2 Instrument How to Clean the Carousel CAUTION A The four sections of the carousel should be thoroughly cleaned and dried before they are replaced in the VITEK 2 instrument The carousel material is designed to withstand any of the fol lowing cleaning methods e Automatic dishwasher with standard laboratory detergent Dishwasher temperatures during the washing and drying cycles must not exceed 85 C 185 F Exceeding this tem perature will cause damage to the carousel sections Use the top rack of the dishwasher e 10 bleach solution e Phenolic cleaning solution NOTE To disinfect a contaminated surface use the 10 bleach solution and allow it to remain in contact with the contaminated surface for five minutes The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument How to Replace the Carousel After Cleaning How to Replace the Carousel After Cleaning After the four carousel sections have been removed the Clean ing menu displays 1 Access the Carousel Cleaning function using the path Cleaning Carousel Cleaning The screen below displays NOTE If the power h
127. here the power switch and cable connectors are found The base unit is actually a small computer It has a processing unit memory and a software program The program in this computer however is limited to the task of entering and storing data for a cassette The back panel of the base unit shown in the figure below con tains the on off switch the power cord receptacle and the con nector ports for various cables On Off Switch Fuse Holder AC Power Receptacle 9 pin Service Update Cable Connector RJ45 Receptacle for the Bar Code Scanner Circular Connector for the SCS Keyboard e 09000906 Contrast adjustment wheel for screen contrast 2 4 The VITEK 2 User s Manual The Smart Carrier Station The SCS Screen The SCS Screen The Smart Carrier Station SCS includes an LCD screen for viewing the data that is being entered This flat black and white display has a compact size so that it requires minimum bench top space The SCS Bar Code Scanner The Smart Carrier Station SCS is equipped with a hand held bar code scanner that can greatly facilitate data entry Without the bar code scanner you would have to key in the information for each test card placed in a cassette With the bar code scan ner you scan a bar code for most data fields The data appears automatically on the display saving you many keystrokes The scanner comes with an optional holder so that the scanner can be positioned for the m
128. i eAnisod wes6 e 10 sped Sy pue QI 9 e6ou wep sured pae yaeu jou op sed A 1S y U9IUA Ul Jed payew e punoj seu jueuunjjsul 9u L 018 je Suldnolm 6c L e3ed uo ur v y Joy osnoue Su o e dos MOH oinpoooud y pu 1Z Z 28ed uo Surueo f snome AOUN O MOH UO au eg Surueo o Jesnores unoyr d Gau pue ojo duroo o spied 10 NEM 9snoJe9 v ur ureuro1 pue suru spied Au JT ALON guo sino 1 ule qoud y Ji xn L yyolq IECH 8 80185220 po Ipod 10 11 9403918 a qu 4940224 PUD ASVSSaP 40445 c g QPL The VITEK 2 User s Manual 8 66 eipoooJd K1940201 sty 4 WO9 2APU no H yye nun ju ummnsur n our spre2 MOU peo T A ALOU JOU p nous nox SurssoooJd usrurj o WY MOJJE ULI no osnodeo 20 ur ureuiad sp1e2 1592 JT CALON eH eui uo uollnq uondo OF eui sseJg lesnojeo eui oiu oeq DUU NOA 181 sped s Aue usng Jesno4eo eui 011 enesseo y woy spJeo 1591 seusnd ey jasno y jo WOO y uisiu euoeui eui 1epeo DIS eui ui wef pJeo 1991 e 10 499u2 y2 Z pue 62 Bed uo eunpeooud y jo q pue p sdeis MO O4 49409 SS929 Jojeqnoui y pue JOOP ssoooe juDu doi eui uedo ueaJos yer eui Duike dsip si 1lu uunu suli 34 j Z 1
129. ia LTDA Diagonal 109 20A 33 Bogot tel 57 1 619 64 70 619 65 70 fax 57 1619 69 10 Denmark bioM rieux Danmark Aps Literbuen 9 Postboks 48 2740 Skovlunde Denmark Tel 45 44 84 68 00 Fax 45 44 53 01 81 Finland bioM rieux Suomi Oy Rajatorpantie 41 C 01640 Vantaa Tel 358 9 8545 6050 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 N rtingen tel 49 70 22 30 07 0 fax 49 70 22 3 61 10 Greece bioM rieux Gerolymatos s a 35 Mihalakopoulou Street 11528 Athens tel 30 1 72 24 904 fax 30 1 72 93 855 India bioM rieux India Pvt Ltd A 10 Green Park New Delhi 110016 tel 91 11 656 99 92 fax 91 11 651 2739 Italy bioM rieux Italia S p A Via Fiume Bianco 56 00144 Roma tel 39 06 52308 1 fax 39 06 52308 240 Japan bioM rieux Japan Ltd Seizan Bldg 12 28 Kita Aoyama 2 chome Minato ku Tokyo 107 0061 tel 81 3 5411 8711 fax 81 3 5411 8710 Korea bioM rieux Korea Co Ltd 7th floor Yoo SUNG Building 830 67 Yeoksam dong Kangnam ku Seoul tel 82 2 547 6262 fax 82 2 547 6263 Mexico bioM rieux M xico S A de C V Chihuahua 88 Col Progreso M xico 01080 D F tel 52 5 550 39 73 550 39 75 fax 52 5 616 22 45 The Netherlands bioM rieux Benelux BV PO box 23 5280 AA Box
130. ield is used to identify the type of Type test card that is to be placed in the cassette slot Organism ID This field is used for identifying an organ ism in an AST card Table 6 2 Smart Carrier Station Data Fields 6 16 The VITEK 2 User s Manual Processing VITEK 2 Test Cards About the Smart Carrier Station Field Description Ancillary Tests This field holds the results of off line tests performed for some test cards Modifier This field is used for organism modifiers Six generic entries mod to mod6 are preloaded When this data reaches the workstation computer the generic entry is converted to one of the first six corre sponding entries in the Organism Modifier table of the bioLIAISON database Dilution Mode The current dilution mode setting always displays on the Data Entry screen NOTE Check the setting before starting a new cassette See callout in Figure 6 6 on page 6 16 Table 6 2 Smart Carrier Station Data Fields The VITEK 2 User s Manual About the Smart Carrier Station Processing VITEK 2 Test Cards Field Description Slot Indicator The slot indicator is the set of boxes at the bottom of the Data Entry screen see call out 6 in Figure 6 6 on page 6 16 The information in the slot indicator is read as follows A number corresponding to the cur rently displayed slot appears over the
131. ignificant growth has begun Light transmittance samplings of the same well every 15 minutes measure organism growth by how much light is prevented from going through the well The optics uses light emitting diodes LEDs that produce light at the appropriate wavelengths and silicon photodetectors to capture the transmitted light The system is self calibrating NOTE The optics should be cleaned periodically See Clean ing the Optics Normal Maintenance on page 7 50 The card ejection function permanently removes test cards from the carousel after their testing is completed The mechanism that performs this function is the same drive belt system that moves the test cards through the reader Instead of returning to the carousel an ejected test card continues on to the waste col lection station The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 The amount of time that cards are held before being ejected automatically from the carousel is set by an option in the Sys tem Configuration window at the workstation computer Cards can also be ejected at any time using a manual ejection function CAUTION Ejected test cards must not be reinserted into VITEK 2 Make sure that all test card processing has been completed K before ejecting a test card The VITEK 2 User s Manual 4 27 What Happens Inside VITEK 2 The VITEK 2 Instrument The Waste Collection Station The card ejector removes te
132. ill require about four minutes The Cancel button pro vided here is the only opportunity to cancel this opera tion Carousel Cleaning Preparing for Section Removal Continue Cancel 4 7 22 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument How to Remove the Carousel for Cleaning 2 Press Continue The following screen displays Carousel Cleaning Remove the incubator access cover now 3 Open the Waste Collection door for the carousel being cleaned 4 Open the top access door or the carousel being cleaned NOTE The remaining steps may be easier if you also remove the Waste Collection tray The VITEK 2 User s Manual 7 23 How to Remove the Carousel for Cleaning Maintaining the VITEK 2 Instrument 5 7 24 Remove the incu bator access cover from the carousel by hold ing the retaining pin on the top of the cover to the right while pulling the cover slightly forward and to the right out of the instrument When you remove the cover the message on the screen changes to this next message while it moves the carousel into position Carousel Cleaning Preparing for Section Removal The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument How to Remove the Carousel for Cleaning When the carousel is in position the following screen displays
133. ilution Mode is set to pre diluted VITEK 2 assumes that the AST dilutions have already been performed 3 4 The VITEK 2 User s Manual Configuring the Smart Carrier Station Why and How to Set the Options How TO SET THIS OPTION 1 Press the F4 key to access the Configuration screen 2 Press f to set the dilution mode to Automatic or 2 to set the dilution mode to Pre diluted manual 3 Press the F2key to exit the SCS Configuration screen or the NEXT or PREVIOUS SCREEN keys to access other configuration screens Station Name A Smart Carrier Station is given a name to identify the cards that were processed on that station This is especially useful in laboratories with multiple Smart Carrier stations The station name consists of one to three alphanumeric charac ters A SCS name could reflect something about the use of the station If for example a particular individual is assigned to an SCS that individual s initials can be used for the SCS name The station s name is stored in the cassette s button memory The name is transferred to the VITEK 2 instrument and is then sent to the computer The station name becomes a part of each test card s address that appears on the card directory The VITEK 2 User s Manual 3 5 Why and How to Set the Options Configuring the Smart Carrier Station How TO SET THIS OPTION 1 2 Key Click Press the F4 key to access the Configuration screen Press the DOWN ARROW key to
134. in closed when process ing cards to avoid exposure to laser light Pages 4 6 4 17 8 41 and 8 49 xviii The VITEK 2 User s Manual Warning Messages The following warnings are used throughout the manual for safety reasons CAUTION Used when a particular action may affect the outcome of a test DANGER Used when a particular action may result in per sonal injury damage to the instrument or create a biohaz ard CAUTION Statements All access doors should remain closed when processing cards Page 4 6 The VITEK 2 test card transport system stops while the cassette load door is open Be sure to close the door after loading or unloading a cassette Page 4 14 Do not move or remove a boat from the instrument unless you are using the programmed function for this purpose Doing so can cause an instrument jam See the procedure for removing boats on page 7 39 Page 4 14 When handling VITEK 2 test cards make sure you do not deface the bar code in any way Page 4 16 The Button Memory chip must be removed from the cassette before cleaning the cassette Page 4 17 The VITEK 2 User s Manual xix Warning Messages XX Ejected test cards must not be reinserted into VITEK 2 Make sure that all test card processing has been completed before ejecting a test card Page 4 27 Do not disable both the audible and visual alarms on the instru ment unless it is located very near to the workstation Doing so makes it mor
135. in the appropriate Online Product Information in the online help system at the workstation Activity For more information see A Make sure that all configuration options are set correctly B Print a cassette worksheet at the workstation C Hill in the cassette worksheet with the test card and specimen informa tion for the cassette D Place the test cards and specimen test tubes in their appropriate slots E Access the Cassette Setup function on the VITEK 2 instrument Select or enter a cassette name and if necessary change the dilution mode F Load the cassette onto the VITEK 2 instrument G Enter the information from the cas sette worksheet into the Cassette Edit window NOTE During the first minute of processing a cassette icon appears on the VITEK 2 Status screen Wait until the boat moves forward to process cards before accessing the Cassette Edit window Configuration Options to Consider on page 6 36 VITEK 2 Online Help System See the topic Entering Cassette Informa tion How to Use the Cassette Worksheet on page 6 39 Correct Positioning of Susceptibility Test Cards on page 6 41 How to Use the Cassette Setup Func tion on page 6 42 Loading a Cassette on page 6 44 Monitoring Test Card Processing on page 6 47 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards in Cassette Only Mode Cassette Preparation Follow these procedures
136. ion 6 1 Aboutthe VITEK 2 Status Screen 6 3 Aboutthe VITEK 2 Menu System 6 10 e About the Smart Carrier Station 6 13 Advantages of Using the SCS 6 13 Data Fields 6 16 Using the Slot Indicator 6 19 SCS Functions 6 19 Option Boxes 6 22 About the Bar Code Scanner 6 24 The VITEK 2 User s Manual 6 1 Introduction 6 2 Processing VITEK 2 Test Cards 77 Test Cards Using the Smart Carrier Station 6 25 Configuration Options to Consider 6 25 The Work Flow 6 26 How to Enter Data With the SCS 6 28 Loading a Cassette 6 31 Processing Test Cards in Cassette Only Mode 6 36 Configuration Options to Consider 6 36 The Work Flow 6 37 Cassette Preparation 6 39 Loading a Cassette 6 44 How to Enter Data for a Cassette 6 48 Batch Loads in Smart Carrier or Cassette Only Mode 6 50 How to Select Batch Loading 6 50 To Begin a Batch Load 6 51 Unloading the Cassette and Removing Waste 6 54 How to Unload a Cassette 6 55 How to Remove Ejected Test Cards 6 57 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Introduction About the VITEK 2 Status Screen You use the Status screen more often than any other screen in the VITEK 2 user interface Since it is so basic to the work flow the Status screen is very easy to display and in many cases the interface displays it automatically How TO DISPLAY IT There are three ways to display the Status scr
137. mentation included with the Instrument including repair service alteration or modification of the system by any person other than service personnel of bioM rieux Inc or Seller or use of modified changed or previously used disposables THE WARRANTY OF SELLER SET FORTH ABOVE AND THE OBLIGATIONS AND LIABILITIES OF SELLER THEREUNDER ARE EXCLUSIVE AND IN LIEU OF ALL OTHER REMEDIES OR WARRANTIES EXPRESS OR IMPLIED ARIS ING BY LAW OR OTHERWISE WITH RESPECT TO THE SYSTEM DELIVERED HEREUNDER INCLUDING WITHOUT LIMITATION ANY OBLIGATION OF SELLER WITH RESPECT TO MERCHANTABILITY FITNESS FOR PARTICU LAR PURPOSE AND CONSEQUENTIAL DAMAGES AND WHETHER OR NOT OCCASIONED BY SELLER S NEGLIGENCE This Warranty shall not be extended or altered except by written instrument signed by Seller All of the product elements in the Seller s Instrument and the total instrument are war rented to be new or equivalent to new for the full product warranty period of one year Disposables and replacement items with a normal life expectancy of less than one 1 year such as batteries and bulbs are excluded from this warranty Table of Contents List Of HU Y pP eene utut nS aus xiii General Warnings coo o edens a ehe XV Laser Caution Statement xviii Caution Statement xviii Warning Messages xix CAUTION Statements xix Danger Statem
138. n utes when setting the time 5 22 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How to Set VITEK 2 Configuration Options To set the Hour for Time A 1 Press the LEFT ARROW key until Hours displays 2 Use the UP or DOWN ARROW keys to set the Hour To set the Minutes for Time A 3 Press the LEFT ARROW key until Minutes dis plays 4 Use the UPor DOWN ARROW keys to set the min utes 5 To schedule another QC Status report select Time B by pressing the NEXT button 6 To exit the function press the ENTER option button The VITEK 2 User s Manual 5 23 How to Set VITEK 2 Configuration Options Configuring the VITEK 2 Instrument How to Use Option Boxes This procedure applies to the following configuration options Cassette Mode Dilution Mode Bar Code Reader Audible Alarm Enable Visual Alarm Enable 1 Access one of the above configuration options using the following path Main Menu Utilities Configuration A screen similar to the following appears Cassette Mode Smart Carrier f Cassette Only 2 To change the current setting press the UP or DOWN ARROW keys 5 24 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How to Set VITEK 2 Configuration Options How to Set a Range Value This procedure applies to the following configuration options Audible Alarm Volume Keyclick Volume Screen Contrast 1 Access one of the ab
139. n See SCS Starting the SCS 2 7 Station name SCS setting 3 5 Station instrument bar code reader 4 16 card ejector 4 26 cassette loading unloading 4 13 dispenser 4 18 filler 4 22 pipettor 4 18 sealer 4 23 waste collection 4 28 6 54 Status instrument 6 4 QC 5 8 Status screen 6 3 7 3 icons 6 8 in an error condition 8 7 8 14 with messages 8 9 8 10 T Temperature checking the instrument 8 35 Time QC status setting 5 22 SCS setting 3 8 The VITEK 2 User s Manual Index Transmittance optics 4 26 cleaning 7 50 Tray waste collection 6 54 U Undo key 4 30 Unloading a cassette 6 55 Updates SCS firmware 3 9 V Vacuum seal cleaning 7 53 Version information 8 54 Visual alarm 5 15 enabling 5 24 Vitek 2 Instrument See Instrument Volume audible alarm 5 14 audible alarm setting 5 25 keyclick 5 16 keyclick setting 5 25 W Waste collection station 4 28 Waste removal 6 54 Work flow and cassette load errors 8 17 with an SCS 6 26 without a SCS 6 37 Worksheet cassette 6 39 Index 5
140. n 10 minutes the instrument assumes that no corrective action will be taken The errors are ignored and the cassette is restarted Any test card in the cassette that has a load error will not be processed The cards remain in the cassette when the cassette returns to be unloaded Whenever you load a cassette the cassette icon appears on the Status screen You should wait until the icon disappears before leaving the instrument Bar Code Read Failure As a cassette passes through the Bar Code Reader station the bar code on each test card is read If the bar code reader is unable to read any of the bar codes e The cassette is backed out to the Cassette Load station The error alarm is activated The VITEK 2 User s Manual 8 17 Cassette Load Processing Errors Troubleshooting the VITEK 2 Instrument How TO RESOLVE A BAR CODE READ ERROR 1 Press the Question Mark key to display the Error queue For a bar code error you see the following message Error Queue Processing Error Bar Code Read Failure at slot NN Message 1 of 1 12 00 114 Figure 8 4 Bar Code Error Message 2 Open the door to the Cassette Load station and remove the cassette The door should remain open while resolving the bar code error DANGER The cassette should be considered as potentially contami nated and should be handled appropriately Qualified labo A ratory personnel should take the usual precautions necessary for infec
141. n wavelength 445 nm Calibration 3 800 RFU 5 with 5 uM 4 MU in CHES pH 9 6 Accuracy and stability 1096 over 6 months Lamp life 30 million flashes minimum The VITEK 2 User s Manual Appendix Hardware Specifications General Characteristics NOTE The specifications below apply to both the VITEK 2 and the VITEK 2 XL CASSETTE Capacity cassettes 4 cassettes maximum Capacity cards 15 cards per cassette DISPENSER Dispensing volume 2 33 2 63 ml Capacity 1000 ml user replaceable PIPETTOR Dispensing volume 60 ul to 300 ul 596 or 5 ul whichever is greater Pipettor drum capacity 330 pipette tips minimum user replace able VACUUM FILLER Minimum level 89 PSIA x 0 06 PSIA SEALER Mechanical stub length 025 mm to 2 5 mm INCUBATOR Temperature 35 5 C 1 C average Capacity 60 cards per Incubator The VITEK 2 User s Manual Appendix 5 Appendix Hardware Specifications Smart Carrier Station Dimensions NOTE The specifications for the Smart Carrier Station apply to both the VITEK 2 and the VITEK 2 XL Width 27 15 cm 10 7 inches Height 28 26 cm 11 1 inches Depth 17 78 cm 7 inches Mass Approximately 2 6 kg 5 85 Ibs Appendix 6 The VITEK 2 User s Manual Appendix Hardware Specifications Environment Indoor Usage Do not install in direct sunlight Relative Humidity 4096 to 8096 non condensing Ambient room temperature 15 C to 30 C Shipment and Storage t
142. ng inside the instrument It can contain a button memory chip that is used to transfer information from the Smart Carrier Station to the VITEK 2 Workstation computer Central Processing Unit the electronics of the personal comput ers and workstations Dispenses 2 5 ml of 0 45 saline into an empty susceptibility card test tube This system includes a saline dispensing system 1 000 ml bag of sterile saline and a fixed volume saline dis penser tube Dispenser Pipettor Transfers and mixes the appropriate inoculum volume predeter mined by the test card bar code 60 uL to 300uL see aliquot to adjacent susceptibility tubes The system includes a container for pipette tips a displacement pump and various tip mecha nisms The VITEK 2 User s Manual Glossary 5 Glossary Disposables VITEK 2 disposables are pipette tips sterile saline test cards and inoculum tubes Disposable supplies are biohazardous after use and must be dis carded according to local laws regarding biohazardous material They should not be recycled or disposed of with normal trash etc Filler station This station inoculates all of the cards in a cassette with the sus pension contained in their corresponding test tubes It utilizes a vacuum chamber and air pump Fluorescence optics The optical detection system designed for use with fluorescence substrates nominal excitation 2365 nm and emission 2445 nm Glossary 6 The VITEK 2 User s Manual
143. ng the VITEK 2 Instrument Cleaning the Carousel Cleaning the Carousel The four sections of a carousel should be removed and cleaned monthly or as conditions require How to Remove the Carousel for Cleaning DANGER The carousel should be considered as potentially contami nated and should be handled appropriately Qualified labo AN ratory personnel should take the usual precautions necessary for infectious agents NOTE This procedure must be performed when the VITEK 2 instrument Is completely idle no cards are processing anywhere in the instrument 1 Access the Carousel Cleaning function using the path Main Menu gt Utilities gt Maintenance gt Cleaning Carousel Cleaning NOTE If there are cards processing anywhere in the instru ment a screen prompts you to make sure processing is complete and all cards have been ejected from the instrument before cleaning The VITEK 2 User s Manual 7 21 How to Remove the Carousel for Cleaning Maintaining the VITEK 2 Instrument If you have a VITEK 2 XL the screen below displays allowing you to select a Reader Carousel Cleaning Reader A Reader B Figure 7 2 VITEK 2 XL Carousel Cleaning Screen If cards are not processing in the selected incubator and the carousel sections have not been removed the follow ing screen displays NOTE When the Continue button is pressed you are required to remove all of the sections This w
144. ns that Light is On The cassette load door is unlocked You may open the door to load cassettes Off The cassette load door is locked and cannot be opened Blinking A boat with an empty cassette has arrived at the station You should open the cassette load door and remove the cassette When the door is closed again the blinking stops Before you attempt to load a cassette make sure the indicator light is On or Blinking The VITEK 2 User s Manual 6 45 Processing Test Cards in Cassette Only Mode Processing VITEK 2 Test Cards How TO LOAD A CASSETTE 1 Openthe Cassette Load station by lift ing the cassette load door up There should be an empty boat at the station or one with a cassette that contains waste DANGER Do not attempt to load a cassette if a boat is not at the sta tion Damage to the cassette and the VITEK 2 instrument is N possible 2 Place the cassette in the boat so that the specimen test tubes are towards the front of the instrument NOTE The boat is shaped such that it will only accept a cas sette in the proper orientation 3 Close the cassette load door The cassette icon appears on the Status screen 4 Monitor the instrument until the cassette icon disap pears and the boat moves forward to process cards 6 46 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards in Cassette Only Mode MONITORING TEST CARD PROCESSIN
145. o open A locking mechanism prevents opening of this door at inap propriate times O Waste collection door Provides access to the Waste Col lection station where ejected test cards are removed from the instrument The door is held in place magnetically and lowers from the top The VITEK 2 User s Manual 4 5 External Components of the VITEK 2 Instrument The VITEK 2 Instrument Access Doors CAUTION All access doors should remain closed when processing cards CAUTION See Laser Caution statement on page xviii N NOTE The top right access door cannot be opened unless the Waste Collection door is opened first Top right access door Provides access to the optics and the carousel The door lifts from the front and stays in the open position NOTE This door is secured by two screws and requires a flathead screwdriver to open Top access door Section A VITEK 2 XL only Provides access to the optics and carousel for Section A Top access door Section B VITEK 2 XL only Provides access to the optics and carousel for Section B Bottom access door Provides access to the drip pan The door is held in place magnetically and must be pulled down to open O Saline access door Provides access to the sterile saline bag The door lifts from the front and stays in the open position 4 6 The VITEK 2 User s Manual The VITEK 2 Instrument External Components of the VITEK 2 Instrument Center front
146. oblems You use the keypad to respond to VITEK 2 instructions send commands to VITEK 2 and to perform other functions Use the diagram below to identify the components of the keypad and screen Option But tons Use these buttons to select menu options or other specified functions 9 Error Mes sage Key Press this key at any time to access the error message queue e e e e e Previous Screen Key Use this key to Exit from a screen or function to its menu Return to a previous screen in a function Go from a sub menu to its previous menu Go from the Main Menu to the Status Screen O Undo Key Use it to cancel the last action performed 4 30 The VITEK 2 User s Manual The VITEK 2 Instrument The User Interface System ARROW Keys Use these keys to Scroll a screen or menu lt w Move the cursor on some screen NOTE When ARROW keys are active their icons appear on the display ENTER Key Use this key to complete data entries or when instructed to do so on a screen NUMERIC Keys Use these keys to enter a number onto a screen The VITEK 2 User s Manual 4 31 5 Configuring the VITEK 2 Instrument Introduction Configuration options allow you to operate the VITEK 2 instru ment in a number of different ways This chapter explains not only how to set these options but how each option affects the operation of the instrument and therefore your laborator
147. oculum for AST cards that have matching ID cards In the Pre diluted mode the Dispenser Pipettor station is disabled WHY USE THIS OPTION If you use a Smart Carrier Station SCS the operation of the Dispenser Pipettor station is determined by the information in the cassette s button memory NOTE If the VITEK 2 instrument is in Smart Carrier mode the Dilution Mode option cannot be accessed If you attempt to use the option the screen displays the mes sage This option is used with cassette only mode However if you are not using an SCS this option must be set as follows To Automatic if you want VITEK 2 to prepare your AST card inocula To Pre diluted if you prepare AST card inocula manually The VITEK 2 User s Manual 5 11 How Configuration Options Affect VITEK 2 Configuring the VITEK 2 Instrument NOTE If the instrument is in Cassette Only mode you can use the Cassette Setup function Main Menu to pro cess individual cassettes in the dilution mode opposite to the configuration setting DANGER Biohazardous spills can occur inside the VITEK 2 instru ment if the Dilution Mode option is not properly set This is A especially true if pre diluted samples are used with the mode set to Automatic How TO SET THIS OPTION The procedure for setting this configuration option is How to Use Option Boxes on page 5 24 Bar Code Reader The VITEK 2 instrument has a bar code station that reads the bar code labels
148. olume of the click can be adjusted to account for labora tory conditions WHY USE THIS OPTION The default setting for the keyclick volume is at the midpoint of its range Use this option to make the appropriate adjustments How TO SET THIS OPTION The procedure for setting this configuration option is How to Set a Range Value on page 5 25 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How Configuration Options Affect VITEK 2 Screen Contrast The VITEK 2 user interface screen uses an LCD display This option controls the amount of background contrast on the dis play WHY USE THIS OPTION Viewing of an LCD screen can be enhanced by changing the contrast under certain lighting conditions Use this option to change the screen if conditions require it How TO SET THIS OPTION The procedure for setting this configuration option is How to Set a Range Value on page 5 25 The VITEK 2 User s Manual 5 17 How to Set VITEK 2 Configuration Options Configuring the VITEK 2 Instrument How to Set VITEK 2 Configuration Options There are eleven configuration options but only four different procedures for setting them depending on the interface used The four interfaces used and the applicable configuration options are shown in the following table Type of Application 7 Interface Configuration Option p page Character set Cassette Names 5 20 nstrument Name Set time Schedule QC Stat
149. on Look for lower volumes of saline in one test tube compared to another Observe the instrument user interface screen for Pipettor error 21 or any Dispenser errors NOTE Ensure there is no sunlight shining directly on the saline dispenser You can continue to use Automatic Dilution Mode if none of the abnormal conditions are observed If you see any of the above abnormal conditions or instrument errors continue to occur please discontinue using Automatic Dilution Mode and contact bioM rieux immediately You can configure the instrument to use the Predilution Mode as described in Chapter 5 of this manual The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Instrument Diagnostics DISPENSER PIPETTOR VOLUMETRIC TEST This test is not required by bioM rieux as part of the recom mended routine maintenance procedures This test has been provided for those laboratories who are required to verify the accuracy of the volumes dispensed by the Pipettor Dispenser by regulatory licensing agencies NOTE The transport system must be idle to perform this test 1 Prepare a fest cassette with the following items two test tubes containing 3 0 ml saline placed in test tube slots 1 and 3 three blank test tubes placed into test tube slots 2 4 and 5 NOTE This cassette does NOT require the use of the Smart Carrier Station 2 Record the weights of the test tubes placed in test tube slots 1 3 and 5 using Ta
150. on the test cards If the reader becomes mis aligned or if some other error occurs in the station you could get repeated error messages about bad bar codes WHY USE THIS OPTION Use this option to disable the bar code reader if there is a prob lem with the station Do NOT use this option unless you think there is a problem in the bar code reader station How TO SET THIS OPTION The procedure for setting this configuration option is How to Use Option Boxes on page 5 24 5 12 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How Configuration Options Affect VITEK 2 Audible Alarm Enable The instrument sounds an audible alarm to alert you to an error condition The alarm stops temporarily when you press any key on the instrument keypad sounding again if you do not access the message queue WHY USE THIS OPTION The Audible Alarm Enable option defaults to Enabled The option to disable the alarm is provided for the case where the instrument is located very near the workstation Since the work station also sounds an alarm disabling the instrument s alarm eliminates this redundancy How TO SET THIS OPTION The procedure for setting this configuration option is How to Use Option Boxes on page 5 24 The VITEK 2 User s Manual 5 13 How Configuration Options Affect VITEK 2 Configuring the VITEK 2 Instrument Audible Alarm Volume The volume of the audible alarm can be adjusted higher or lower to account
151. onfiguration sider on page 6 25 options are set cor rectly Fields of the Data Entry Screen on page 6 16 B Insert a cassette to Step 1 on page 6 28 display the Data Entry screen 6 26 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards Using the Smart Carrier Station Activity For more information see C Select a slot in the Using the Slot Indicator on cassette for the first page 6 19 test card and speci men SCS Functions on page 6 19 NOTE The SCS automatically starts with slot 1 and fills the cassette sequentially Slot selection is there fore an optional activ ity D Enter the informa e How to Enter Data With the tion for the first test SCS on page 6 28 card and specimen e Using the SCS bar SCS Functions on page 6 19 code scanner or e Using the SCS key Option Boxes on page 6 22 board E Place the first test N A card and specimen test tube in their appropriate slots F Continue activities N A C D and E for the remainder of the cassette The VITEK 2 User s Manual 6 27 Processing Test Cards Using the Smart Carrier Station Processing VITEK 2 Test Cards How to Enter Data With the SCS The Data Entry screen is used to store information about speci mens and their test cards You enter the information by posi tioning the cursor in a data field for a particular test card slot By default the cursor is always in the Accession I
152. or error press the Down Arrow to review and address each message Message Queue Hardware Error Optical Controller Failure Message 2 of 5 A 12 00 106 Hardware Error The first line in the error message queue gives you the Primary Error Code For examples of other Primary Error Codes see Table 8 2 Optical Controller Failure The second line of the error message queue tells you the Secondary Error Code For examples of other Secondary Error Codes see Table 8 2 Message 2 of 5 The third line in the error message queue is the message counter The counter tells you how many messages are in the queue O 106 The last line of the queue is the error code This code contains information for a bioM rieux service rep resentative should you need to call for assistance 12 00 Time the error occurred The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument The Error Handling System STATUS SCREEN WITH A STATUS OF ERRORS This status appears after the error message queue is accessed if the error condition has not been resolved or the recovery proce dure was not successful This status can be cleared only by resolving the condition that generated the original message Status Errors MAX Available Slots 60 Cassette Name NSB Dilution Mode Automatic Tips Saline Review the error message queue for any error messages the VITEK 2 instrument has generate
153. ormation on periph erals computer printer monitor etc please refer to the relevant manufacturers instruc tion manuals If the system does not respond properly to keyboard inputs after an inadvertent electro static discharge or electrical fast transient simply recycle power using the power switch and resume normal operations XV General Warnings xvi CAUTION CAUTION This product carries the CE label to comply with the limits pursuant to European direc tives The equipment has been tested and found to comply with the limits pursuant to the rules and standards indicated in the certificate sent with the product These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential commercial or light industrial environment The equipment generates uses and can radi ate radio frequency energy and if not installed in accordance with the instruction manual may cause harmful interference to radio communications We recommend that you observe the different warnings inscribed on the instrument itself and indicated in the documentation supplied Changes to the equipment not expressly approved by bioM rieux SA could void the user s author ity to operate the equipment The user will be required to repair damage at their own expense bioM rieux SA is in no case liable for any damage that may arise from failure to com ply with technical s
154. ory Reader 4 17 VITEK 2 Dispenser Pipettor Station 4 18 The Filler Station 4 22 The VITEK 2 User s Manual 4 1 Introduction 42 The VITEK 2 Instrument The Sealer Station 4 23 Test Card Incubation and Reading 4 23 Card Ejection 4 26 The Waste Collection Station 4 28 The User Interface System 4 29 Keypad and Screen 4 30 The VITEK 2 User s Manual The VITEK 2 Instrument External Components of the VITEK 2 Instrument External Components of the VITEK 2 Instrument The picture on the following page contains a front and a left side view of the VITEK 2 and VITEK 2 XL instrument Use the diagram to locate and familiarize yourself with the external controls and the access doors to the interior of the instrument The VITEK 2 User s Manual 4 3 External Components of the VITEK 2 Instrument The VITEK 2 Instrument VITEK 2 60 Instrument VITEK2 XL Instrument qa The VITEK 2 User s Manual The VITEK 2 Instrument External Components of the VITEK 2 Instrument Controls and Connections User Interface Screen and Keypad This screen and key pad comprise the User Interface system See page 4 29 for detailed information O Front access door Provides access to the diluter pipette tip container and a portion of the test card transport sys tem The door opens from the right side O Cassette Load Unload door Provides access to the Cas sette Load Unload station The door slides up t
155. ost efficient work flow The SCS Keyboard The Smart Carrier Station SCS keyboard has a standard set of alphabetic and numeric keys It also has several keys that are uniquely designed for use on the SCS The VITEK 2 User s Manual 2 5 The SCS Keyboard The Smart Carrier Station F9 F10 P This is the HELP key You use it to display the context sensitive help screens and data field option boxes E E gt This key has two functions When you press the arrow on the left the display changes to the PRE VIOUS SLOT When you press the arrow on the right the dis play changes to the NEXT SLOT as you would on any keyboard This is the SHIFT LOCK key When you press ge it the light next to it goes on and the keypad stays in the upper case mode Press the Shift Lock key again to cancel upper case mode This is the SHIFT key Use it to type upper case letters For detailed descriptions of all the functions of the SCS key board see the table on page 6 19 2 6 The VITEK 2 User s Manual The Smart Carrier Station Starting the Smart Carrier Station Starting the Smart Carrier Station Use this procedure to begin using the Smart Carrier Station SCS The unit should be located on a bench top with room next to it for test cards and specimens Use the following figure of the back of the SCS to locate and identify the various parts referred to in the procedure 1 Tilt the SCS scr
156. ou wish to continue 4 Press the Yes option button A message on the display will instruct you to load the cas sette that you prepared in step 1 5 Open the cassette load door load the test cassette and close the cassette load door 6 Allow the cassette to process and return to the cas sette load unload door Remove the cassette 7 Record the weights of the test tubes placed in test tube slots 1 3 and 5 using Table 8 1 Record the weight of the tube in slot 1 in the Pipettor Low Volume section Test tube 1 After test A Record the weight of the tube in slot 3 in the Pipettor High Volume section Test tube 3 After test A Record the weight of the tube in slot 5 in the Diluter section Test tube 5 After test A The VITEK 2 User s Manual 8 41 Instrument Diagnostics Troubleshooting the VITEK 2 Instrument 8 Determine if the Dispenser Pipettor is performing to specification by performing the following calculations using Table 8 1 Inthe Pipettor Low Volume section subtract the weight of tube 1 A from the weight of 1 B The acceptable value must be between 095 gm to 105 gm Inthe Pipettor HighVolume section subtract the weight of tube 3 A from the weight of tube 3 B The acceptable value must be between 285 gm to 315 gm In the Diluter section subtract the weight of tube 5 B from the weight of tube 5 A The acceptable value must be 2 33 gm to 2 63 gm NOTE If the values reco
157. ove configuration options using the following path Main Menu gt Utilities Configuration The VITEK 2 User s Manual 5 25 How to Set VITEK 2 Configuration Options 1 Configuring the VITEK 2 Instrument Below is an example of a range value screen Screen Contrast Press the DOWN ARROW to view the configuration options A range bar appears Change the range value by pressing the LEFT or RIGHT ARROW keys The bar graph and the numeric value change and the actual parameter change in response to this action The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How to Set VITEK 2 Configuration Options NOTE Do NOT set the screen contrast to either end of its available range Doing so may make the screen unus able NOTE For the Audible Alarm Volume parameter a test but ton is provided to sound the alarm The VITEK 2 User s Manual 5 27 6 Processing VITEK 2 Test Cards Introduction This chapter contains the procedures you need to process VITEK 2 test cards The chapter begins with three introductory sections that provide reference information about the VITEK 2 Status screen the VITEK 2 Menu system and the Smart Carrier Station interface The next two sections contain suggested work flows and the procedures for working either with or without a Smart Carrier Station The final section deals with unloading test cards from the instrument Where to Find It Introduct
158. ower switch to the ON position The system goes through the initialization process When the Status Screen appears it will display a status of Clean ing indicating that all four boats have been removed 2 Perform the boat replacement procedure that begins on page 7 42 After all four boats have been replaced the Status Screen should display a status of OK NOTE If the instrument was shut down for a long period of time the status may be Warming Wait until the sta tus is OK before resuming test card processing The VITEK 2 User s Manual 7 59 Cleaning the Smart Carrier Station Maintaining the VITEK 2 Instrument Cleaning the Smart Carrier Station DANGER All organism suspensions should be considered as poten tially infectious Qualified laboratory personnel should use acceptable procedures for biohazardous material NOTE This procedure should be performed monthly or as conditions require How to Clean the Smart Carrier Station SCS The SCS base unit keypad display and bar code scanner except the glass lens are designed to withstand any of the fol lowing cleaning methods 1096 bleach solution Phenolic cleaning solution 1 Remove the cassette if one is on the SCS base unit 2 Push the AC power switch on the SCS to the off position 7 60 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument CAUTION A 3 4 To prevent damage to the metal contacts on the SCS base unit
159. pecifications in this man ual from the handling of organism suspensions by unqualified personnel or from any operation conducted on the equip ment not in compliance with these manda tory standards The VITEK 2 User s Manual DANGER DANGER The VITEK 2 User s Manual General Warnings This instrument may be involved with haz ardous organism suspensions This user manual does not purport to address all of the safety problems associated with its use It is the responsibility of whoever uses this instrument to establish and follow appropri ate safety and health practices and to deter mine the applicability of regulatory limitations prior to use All organism suspensions should be consid ered as potentially infectious Qualified labo ratory personnel should use acceptable procedures for biohazardous material xvii Laser Caution Statement Laser Caution Statement The label below is found VITEK 2 Don the front access door on the inside panel behind the front access door S behind the waste collection door VITEK 2 XL Don the left front access door above the center front sliding door behind the right side waste collection door CAUTION Laser light when open DO NOT STARE INTO BEAM 00 530520 1 Caution Statement Caution use of controls or adjustments or performance of pro cedures other than those specified herein may result in hazard ous radiation exposure All access doors and covers must rema
160. r codes entering manually 8 31 Base pan cleaning 7 53 Base unit SCS 2 4 The VITEK 2 User s Manual Batch loading 6 50 6 51 Boat 4 15 cleaning 7 39 7 42 removing 7 39 Button memory removing from a cassette 7 36 C Card AST matching with ID 6 14 Card capacity errors 8 26 eJected removal of 6 57 eJector station 4 26 monitoring processing of 6 34 6 47 Card capacity of the Instrument 6 5 Card processing monitoring 6 34 6 47 Card type errors 8 16 Card type field 6 16 Carousel 4 24 cleaning 7 21 7 33 removing 7 21 Cassette 4 10 6 14 cleaning 7 34 data entry without a SCS 6 48 errors in loading 8 15 8 25 loading into the instrument 6 31 6 34 6 44 6 46 loading unloading station 4 13 6 45 unloading 6 55 Cassette address 6 35 6 49 Cassette erase 3 10 Cassette icon 6 8 Cassette mode 5 10 Index 1 Index Cassette name 5 5 defining 5 20 on the status screen 6 7 selecting in cassette setup function 6 43 Cassette setup function using 6 42 Cassette worksheet 6 39 Caution definition of 1 5 Changing pipette tips 7 14 7 20 saline 7 6 7 12 Character sets defining for cassette or instrument name 5 20 Checking the instrument temperature 8 35 Cleaning base pan 7 53 boats 7 39 7 45 carousel 7 21 7 33 cassettes 7 34 7 39 drip pan 7 56 7 58 instrument 7 46 7 48 optics 7 50 optics with cards processing 8 43 vacuum seal 7 53 Configuration options instrument 5 3 effects on the instrument
161. ratory Workers from Instrument Bio hazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline 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 Smart Carrier Station Temperature Label 30 C 4 Indicates a maximum ambient temperature of 30 C The newer Smart Carrier Stations beginning with Serial Number SCSA 3000 have a Maximum Temperature Label affixed to the Smart Carrier Station The VITEK 2 User s Manual xxix 1 How To Use This Manual Organization The manual is separated into four basic parts Part 1 which includes Chapters 2 and 3 covers the Smart Carrier Station Chapter 2 describes the hardware and Chap ter 3 provides the procedures you use to configure this sta tion for your laboratory work flow Part 2 which includes Chapters 4 and 5 covers the VITEK 2 Instrument Chapter 4 describes the hardware and Chapter 5 shows you how to configure the instrument s user inter face Part 3 including only Chapter 6 is the primary part of the manual It describes all of the procedures you need to follow to process VITEK 2 test cards The chapter contains two subparts one each to describe test card processing with and without a Smart Carrier Station Part 4 consisting of Chapters 7 and
162. rded in the tables are not within the recommended range call bioM rieux for assistance 8 42 The VITEK 2 User s Manual Troubleshooting the VITEK 2 InstrumentCleaning and Verifying the Optics with Cards Processing Cleaning and Verifying the Optics with Cards Processing DANGER A CAUTION CAUTION A This procedure allows you to clean and verify the optics while test cards are still processing Use the Optics Cleaning proce dure in Chapter 7 if the instrument is shut down NOTE All steps in this procedure must be completed The instrument contains an ultraviolet light source Make sure that the fluorescence optics unit is closed before resum ing instrument operation Do not wear powdered latex gloves while cleaning the fluo rescence optics The gloves that contain a powder can inter fere with the optics See Laser Caution statement on page xviii 1 Access the Optics Cleaning function using the path Main Menu gt Utilities Maintenance gt Cleaning Optics Cleaning The VITEK 2 User s Manual 8 43 Cleaning and Verifying the Optics with Cards ProcessingTroubleshooting the VITEK 2 Instrument If cards are processing the following screen appears Optics Cleaning Cards are currently processing Do you wish to continue 2 Press the Yes option button to continue The screen briefly displays the message Preparing for Optics Cleaning NOTE If
163. rip pan may include biohazardous materi als Take appropriate precautions Page 7 57 The cassette should be considered as potentially contaminated and should be handled appropriately Qualified laboratory per sonnel should take the usual precautions necessary for infec tious agents Page 8 18 The instrument contains an ultraviolet light source Make sure that the fluorescence optics unit is closed before resuming instrument operation Page 8 43 The VITEK 2 User s Manual XXV Standard Symbols The symbols used in the VITEK 2 system are shown below Direct current db Alternating current Both direct and alternating current 4 37N Three phase alternating current Earth ground terminal IK Protective Conductor terminal Frame or chassis terminal Equipotentiality 4 6 The VITEK 2 User s Manual xxvii Standard Symbols On supply Off supply On only for part of equipment QE Off only for part of equipment gt Equipment protected throughout by DOUBLE INSULATION or REINFORCED INSULATION equivalent to Class II of IEC 536 Caution risk of electric shock D A Caution N Caution elevated temperature xxviii The VITEK 2 User s Manual Standard Symbols AD Caution biological agents Refer to the publications below for instructions on handling biohazardous materials National Committee for Clinical Laboratory Standards M29 A Protection of Labo
164. rom the option box Place the cursor in the Modi fier field and press the Help key Select a modifier from the option box NOTE If you need to change any of the data you have entered you must do so before you remove the cas The VITEK 2 User s Manual sette from the SCS 6 29 Processing Test Cards Using the Smart Carrier Station Processing VITEK 2 Test Cards CORRECT POSITIONING OF AST CARDS If you pre dilute the inocula for the susceptibility tests you can place the test cards into any slots in the cassette in any order you choose However when VITEK 2 is performing the dilu tion Automatic dilution mode you must follow these rules The AST card must be placed in a slot immediately follow ing the slot containing the inoculum test tube A gram negative inoculum can be used for either one or two susceptibility tests When diluting the inocula for two tests the test cards must occupy the two slots immediately fol lowing the slot containing the inoculum test tube These rules apply whether or not an ID card is used 6 30 The VITEK 2 User s Manual Processing VITEK 2 Test Cards Processing Test Cards Using the Smart Carrier Station Loading a Cassette DANGER The cassette should be considered as potentially contami nated and should be handled appropriately Qualified labo A ratory personnel should take the usual precautions necessary for infectious agents After the information for a cassette has
165. ror Log whether or not they are resolved The log is cleared when the instrument is turned off 8 6 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument The Error Handling System The Status Screen in an Error Condition Depending on the type of error you will see one or more types of screens Instrument Halted Screen Indicates an error has caused the Reader or Card Transport system to halt Status screen with a status of Messages Indicates there are error messages that need to be reviewed These are minor errors that do not cause the Reader or Card Transport to halt There are two ways you can handle a Status screen with a status of Messages Review the message and resolve the condition as indicated in Table 8 2 Review the message and decide not to resolve the condition NOTE If the first error recovery procedure directs you to con tact bioMerieux do so immediately Status screen with a status of Error Indicates a message has been reviewed but not resolved or the recovery proce dure was not successful This status can only be cleared by resolving the condition that caused the original error The VITEK 2 User s Manual 8 7 The Error Handling System Troubleshooting the VITEK 2 Instrument INSTRUMENT HALTED SCREEN Instrument Halted Reader Halted Processing Card Transport Halted Processing Minutes Messages Pending 12 00 Go
166. s 3 9 Cassette Erase 1 222 hte eae SES RR 3 10 4 The VITEK 2 Instrument MtroductiOn sz eee tues a tee ER aes 4 Where to Find TEL coe EE HS 4 1 External Components of the VITEK 2 Instrument 4 3 Controls and Connections 4 5 Access Doors ii ege usia wa yaaa ERE b d 4 6 Turning on the VITEK 2 Instrument 4 8 Starteup Procedure utut o eed Lex LLLA Sd 4 8 What Happens Inside VITEK 2 4 9 Test Card Processing Cycle 4 9 The Smart Carrier Station SCS 4 10 iLhe Cassettes en donee Fuere e E 4 10 Cassette Load and Unload Station 4 13 Mhe Boats eer dos s l 4 15 VITEK 2 Bar Code Reader 4 16 The Button Memory Reader 4 17 VITEK 2 Dispenser Pipettor Station 4 18 The Filler Station 4 22 the Sealer TEE 4 23 Test Card Incubation and Reading 4 23 Card Ejection aeu REN see oL E Red 4 26 The Waste Collection Station 4 28 The User Interface System 4 29 Keypad and Screen 4 30 viii The VITEK 2 User s Manual Table of Contents 5 Configuring the VITEK 2 Instrument Introduction Buda 5 1 WMhere to Emd It 2222s vote S XM EY oes 5 1 Configuration Overview
167. s Manual Maintaining the VITEK 2 Instrument Cleaning the Inside of the VITEK 2 Instrument Cleaning the Base Pan Vacuum Seal and Vacuum Chamber NOTE Perform the instrument shutdown procedure on page 7 46 before proceeding with this procedure NOTE If the boats have not already been removed perform the procedure to remove them See page 7 39 The VITEK 2 User s Manual 7 53 Cleaning the Inside of the VITEK 2 Instrument Maintaining the VITEK 2 Instrument DANGER A The base pan should not be cleaned unless the drip pan is properly installed See 7 56 for instructions on cleaning the drip pan The base pan vacuum seal and vacuum chamber are designed to withstand any of the following cleaning methods 10 bleach solution e Phenolic cleaning solution NOTE Remove all boats see procedure on page 7 39 and shut down the instrument see procedure on page 7 46 before performing this procedure The base pan is the surface on which the boats move The vac uum seal is the bottom surface of the vacuum chamber where the chamber makes contact with a boat see arrow in figure below The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Inside of the VITEK 2 Instrument 1 Using a solution of disinfectant and warm water wipe off any dust or dirt from the surface of the base pan Particular attention should be paid to the area beneath the Dispenser Pipettor station where drips or spill
168. s at the same time Using your right hand grasp the optics unit and place your thumb on the lever 9 see figure at right Push down on the ever to release the unit and allow it to rotate on n its hinges The VITEK 2 User s Manual Troubleshooting the VITEK 2 InstrumentCleaning and Verifying the Optics with Cards Processing 7 Inspectthe glass on both surfaces for cracks or scratches NOTE Any apparent crack or scratch should be reported to bioM rieux 8 Using a quality lint free lens paper that has been slightly moistened with a commercial glass cleaner clean the glass surfaces If foreign material remains on either surface repeat this step using an alcohol wipe Squeeze out excess alcohol before using and dry the surface with lens paper Make sure that you do not leave streaks on the glass 9 Rotate the unit back into place while pushing down slightly on the lever until it is secured 10 Replace the empty test card collection tray in the Waste Collection station 11 Close the top access door then close the Waste Collection station door The VITEK 2 User s Manual 8 47 Cleaning and Verifying the Optics with Cards ProcessingTroubleshooting the VITEK 2 Instrument 12 Press the Cleaning completed option button that was displayed in the screen in step 2 NOTES If step 12 is not completed within the five minutes allowed test card processing resumes automatically If the optics are still
169. s may have occurred NOTE To disinfect a contaminated surface use the 10 bleach solution and allow it to remain in contact with the contaminated surface for five minutes 2 Using plain water wipe the same surfaces again to remove any disinfectant residue 3 Repeatsteps 1 and 2 to clean the vacuum seal and the interior surface of the vacuum chamber NOTE The remaining cleaning procedures in this section do not require that the instrument be shut down You can now turn the instrument back on using the procedure on page 7 59 The VITEK 2 User s Manual 7 55 Cleaning the Drip Pan Maintaining the VITEK 2 Instrument Cleaning the Drip Pan DANGER All organism suspensions should be considered as poten tially infectious Qualified laboratory personnel should use AN acceptable procedures for biohazardous material NOTE This procedure should be performed monthly or as conditions require VITEK 2 has a small container called the drip pan located underneath the Dispenser Pipettor station The pan is designed to catch any spills that occur at this station NOTE This procedure should be performed after you clean the base pan See Cleaning the Base Pan Vacuum Seal and Vacuum Chamber on page 53 7 56 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Cleaning the Drip Pan Removing the Drip Pan 1 Lower the bottom access door located in the bot tom front portion of the instrument The plate is
170. s the card s test type lot number and expiration date which is entered either by the SCS subsystem by bar code wanding or when the test card s bar code label is read by the bar code reader inside of the VITEK 2 instrument The tray like device that carries the cassette around the instru ment It forms the bottom of the vacuum chamber and helps to capture any spills It is removable for cleaning The VITEK 2 User s Manual Glossary 3 Glossary Button memory Button memory A Button Memory is a microchip located in a clip underneath the Cassette that stores test card information that is entered at the Smart Carrier Station During the entry cycle of processing the data is transferred to the workstation computer by the button memory reader reader A magnetic data storage device that reads the button memory and sends data entered at the Smart Carrier Station to the VITEK 2 workstation computer Card transport system Carousel Glossary 4 Moves the test cards among the stations within the VITEK 2 instrument It consists of the cassette tray boat cassette loading and unloading station electromechanical arms card ejectors and the waste collector station The rotating incubator section which holds up to 60 test cards per incubator The VITEK 2 User s Manual Cassette CPU Dispenser Glossary The cassette is a card and test tube carrier that holds up to 15 tests It is used for sample preparation and processi
171. se cassettes that have been processed Select Verify First to display and review data before it is erased 3 10 The VITEK 2 User s Manual Configuring the Smart Carrier Station Why and How to Set the Options 3 Press 1 and 2to toggle between Automatic and Ver ify First NOTE If you select Verify First when you place a cassette that has been processed by the instrument on the Smart Carrier Station the following message displays Cassette has been processed Press F1 to erase any other key to display processed information 4 Press F2to exit the screen The VITEK 2 User s Manual 4 The VITEK 2 Instrument Introduction This chapter describes the hardware systems in the VITEK 2 instrument The section External Components of the VITEK 2 Instrument points out the controls and connections found on the instrument s exterior and the doors by which you gain access to its interior The section What Happens Inside VITEK 2 describes the work stations and components in the instrument Where to Find It External Components of the VITEK 2 Instrument 4 3 Controls and Connections 4 5 Access Doors 4 6 Turning on the VITEK 2 Instrument 4 8 Start up Procedure 4 8 What Happens Inside VITEK 2 4 9 Test Card Processing Cycle 4 9 The Smart Carrier Station SCS 4 10 The Cassettes 4 10 Cassette Load and Unload Station 4 13 The Boats 4 15 VITEK 2 Bar Code Reader 4 16 The Button Mem
172. should be handled appropriately Qualified laboratory per sonnel should take the usual precautions necessary for infec tious agents Page 7 21 The cassettes should be considered as potentially contaminated and should be handled appropriately Qualified laboratory per sonnel should take the usual precautions necessary for infec tious agents Page 7 34 Exposing the button memory to the recommended cassette cleaning procedures can cause irreparable damage to the unit Page 7 34 The boats should be considered as potentially contaminated and should be handled appropriately Qualified laboratory personnel should take the usual precautions necessary for infectious agents Page 7 39 All organism suspensions should be considered as potentially infectious Qualified laboratory personnel should use accept able procedures for biohazardous material Page 7 46 and 7 56 There are elevated temperatures and hot surfaces inside the instrument Shut down the instrument before starting the clean ing or any other procedures inside the instrument Page 7 46 The base pan should not be cleaned unless the drip pan is prop erly installed See 7 56 for instructions on cleaning the drip pan Page 7 54 All organism suspensions should be considered as potentially infectious Qualified laboratory personnel should use accept able procedures for biohazardous material Page 7 56 The VITEK 2 User s Manual Warning Messages The contents of the d
173. sing the Slot Indicator 6 19 SC S FUNCIONS 6 19 Option BOXES e d paci pote S pied ed M pa Rl eos In 6 22 About the Bar Code Scanner 6 24 Processing Test Cards Using the Smart Carrier Station 6 25 Configuration Options to Consider 6 25 The Work BIOW teu nba saan TE PER EDS 6 26 How to Enter Data With the SCS 6 28 Loading a Cassette 6 31 Processing Test Cards in Cassette Only Mode 6 36 Configuration Options to Consider 6 36 The Work FLOW ioes z vent S ex wn sale ex OR VS 6 37 Cassette Preparation 6 39 Loading a Cassette 6 44 How to Enter Data for a Cassette 6 48 Batch Loads Smart Carrier or Cassette Only Mode 6 50 How to Select Batch Loading 6 50 To Begin a Batch Load 6 51 Unloading the Cassette and Removing Waste 6 54 How to Unload a Cassette 6 55 How to Remove Ejected Test Cards 6 57 x The VITEK 2 User s Manual Table of Contents 7 Maintaining the VITEK 2 Instrument Introduction det 77 7 1 Wheteto EImddto apene ues dex D usu qs 7 1 Maintaining the VTTEK 2 Disposables 7 3 Monitoring the Disposables 7 3 The Dispenser Pipettor Accessory
174. sliding door VITEK 2 XL only The Cassette load unload door 9 must be opened first before this door can be opened 11 UPS connection This cable connector port connects VITEK 2 to an uninterruptable power supply UPS The connection allows the UPS to notify the VITEK 2 of a power loss so that the VITEK 2 can start appropriate proce dures 12 Workstation connection This connector port accepts the cable that connects the VITEK 2 instrument to the worksta tion computer 13 AC power switch and cord receptacle This switch sup plies power to the VITEK 2 instrument The cord receptacle accepts the power cord that is connected to the electricity source The VITEK 2 User s Manual 4 7 Turning on the VITEK 2 Instrument The VITEK 2 Instrument Turning on the VITEK 2 Instrument NOTE Refer to the environmental and electrical specifica tions for the VITEK 2 instrument in the Appendix before starting the instrument Start up Procedure 1 Make sure VITEK 2 has been connected to an appropriate power supply using the power cord sup plied with the instrument 2 Press the AC power switch to the ON position See item 13 in the figure on page 4 4 The instrument goes through an initialization sequence that includes several self tests During this time VITEK 2 is also bringing the carousel area up to its specified temperature for test card incubation After a few minutes the VITEK 2 Status Screen appears The Status field at
175. ss the LEFT or UP ARROW Number field keys to move to the Isolate field PN FM Table 6 3 Summary of SCS Functions The VITEK 2 User s Manual 6 19 About the Smart Carrier Station Processing VITEK 2 Test Cards Use these keys To Do this Display an adjacent slot Press the NEXT or PREVIOUS SLOT key Copy data to the cur rent slot 1 Information must have been entered in a previous slot Press the F1 key to copy the appropriate data from the pre vious slot Exit a screen Press the F2 key BEBE RS ration screen Display the Summary 1 Press the F3 key to display the screen first summary screen 2 Press the NEXTor PREVIOUS SLOT key to display the sec ond summary screen F Display the Configu Press the F4 key Display data for a non adjacent slot Press the F5 key A popup prompt appears Enter the slot number you want to display Display the Flex Panel Entry screen Press the F6 key Erase the data in the current field Press the F8 key 6 20 Table 6 3 Summary of SCS Functions The VITEK 2 User s Manual Processing VITEK 2 Test Cards About the Smart Carrier Station To Do this keys Erase the data for a 1 Press the F9 key A confirma slot tion window appears NOTE This func 2 Press the F1 key to erase the tion also erases data data in any successive
176. ssed If you attempt to use the option the screen displays the mes sage This option is used with cassette only mode How TO SET THIS OPTION The procedure for setting this option is How to Define Charac ter Sets on page 5 20 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How Configuration Options Affect VITEK 2 Instrument Name The Instrument Name option allows you to name a VITEK 2 instrument module The name can contain up to 20 printable characters including spaces The instrument name can be help ful in those laboratories with more than one VITEK 2 instru ment to segregate for example specimen types or technologists The instrument name also displays on the Direc tory window at the VITEK 2 workstation WHY USE THIS OPTION The VITEK 2 instrument names default to Instrument 1 Instrument 2 etc You should use this option if you have more than one instrument module By assigning each instru ment module a different name you can view test card directo ries by the instrument in which they are being processed How TO SET THIS OPTION The procedure for setting this option is How to Define Charac ter Sets on page 5 20 The VITEK 2 User s Manual 5 7 How Configuration Options Affect VITEK 2 Configuring the VITEK 2 Instrument Schedule Instrument QC Status The QC Status is a report of the current incubator temperature and the status of the optics systems The report is sent to the VITEK 2
177. st cards that have completed test ing from the reader These test cards are collected in a tray at the Waste Collection station for removal from VITEK 2 and dis posal The station shown here holds up to 60 test cards The instrument counts test cards as they fill the tray and sends a mes sage to the VITEK 2 interface screen when the station is full A sensor in the station detects when the tray has been emptied or if the tray is missing Access the Waste Collection station by opening the waste col lection door on the front of VITEK 2 428 The VITEK 2 User s Manual The VITEK 2 Instrument The User Interface System NOTES Keep the waste collection station door closed except when test cards are being removed from the station Empty the waste collection tray after loading a new cassette into the instrument Periodically remove the waste collection tray for cleaning See Cleaning the Test Card Collection Tray on page 7 49 The User Interface System Throughout the entire processing cycle for test cards communi cation between the user and VITEK 2 is essential The User Interface System of VITEK 2 provides the means of that com munication The VITEK 2 User s Manual 4 29 The User Interface System The VITEK 2 Instrument Keypad and Screen A keypad and screen are located on the front of VITEK 2 VITEK 2 uses the screen to send you messages about its opera tion on board disposables and possible pr
178. system does not have a Smart Carrier Station refer to the section Processing Test Cards in Cassette Only Mode on page 6 36 Configuration Options to Consider Before using the SCS make sure that the following options are properly set On the Smart Carrier Station All of the configuration options on the SCS should be set The most important of these is the Dilution Mode option Make sure that it corre sponds to how susceptibility inocula are processed for this cassette See AST Dilution Mode on page 3 4 Onthe VITEK 2 Instrument The most important config uration option for using the SCS is the Cassette Mode option This option must be set to Smart Carrier The VITEK 2 User s Manual 6 25 Processing Test Cards Using the Smart Carrier Station Processing VITEK 2 Test Cards The Work Flow The following table provides a general work flow for using the Smart Carrier Station SCS This work flow assumes that you have selected the VITEK 2 test cards to process decided whether to prepare susceptibility suspensions man ually or automatically using VITEK 2 NOTE If you choose to prepare suspensions manually sus pension preparation instructions can be found in the appropriate Online Product Information in the online help system at the workstation prepared the inocula and have all material positioned by the SCS Activity For more information see A Make sure that all Configuration Options to Con c
179. t access door of VITEK 2 to expose the Pipettor station 4 Open the Pipette Tip access door The VITEK 2 User s Manual 7 15 Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument 5 Rotate the pipette tip container 90 in a coun terclockwise direction 6 Remove the pipette container from its base using a pulling motion 7 Discard any pipette tips that remain in the con tainer CAUTION To avoid contaminating new pipette tips do not touch the inside of the pipette container 7 16 The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables NOTE Discarding the remaining tips is required in order for VITEK 2 to maintain an accurate count of them This action also minimizes the risk of contamination 8 Opena pipette tip replacement pack and hold it in one hand see figure on following page The VITEK 2 User s Manual 7 17 Maintaining the VITEK 2 Disposables CAUTION AN Maintaining the VITEK 2 Instrument The exposed ends 9 of the pipette tips are the ones that come in contact with your specimens Appropriate precau tions to prevent contamination during this procedure are advised 10 11 Hold the empty pipette container in your other hand with its open end down and lower it over the exposed ends of the pipette tips Invert the container and pack so that the pipette tips
180. t cards and specimens Slot Numbers The worksheet is preprinted with the fifteen slot numbers CORRECT POSITIONING OF SUSCEPTIBILITY TEST CARDS If you pre dilute the inocula for the susceptibility tests you can place the test cards into any slots in the cassette in any order you choose However when VITEK 2 is performing the dilu tion Automatic dilution mode you must follow these rules The AST card must be placed in a slot immediately follow ing the slot containing the inoculum test tube A gram negative inoculum can be used for either one or two susceptibility tests When diluting the inocula for two tests the test cards must occupy the two slots immediately fol lowing the slot containing the inoculum test tube These rules apply whether or not an ID card is used The VITEK 2 User s Manual 6 41 Processing Test Cards in Cassette Only Mode Processing VITEK 2 Test Cards 6 42 How TO UsE THE CASSETTE SETUP FUNCTION Use the cassette setup function to define the cassette name to the instrument and if necessary to change the Dilution Mode setting for a cassette 1 Access the Cassette Setup function on the Main Menu NOTE If the VITEK 2 instrument is in Smart Carrier mode the Cassette Setup function cannot be accessed If you attempt to use the option the screen displays the mes sage This option is used with Cassette Only mode Cassette Names 0 ABC 3 1 URN 9 6 2 PBI T 3 8 4
181. table times The VITEK 2 User s Manual 8 15 Cassette Load Processing Errors Troubleshooting the VITEK 2 Instrument Why Do They Occur During the first minute of processing a cassette passes through the Bar Code and Button Memory stations During this time the button memory of a smart cassette and the bar codes on all test cards are read From this information VITEK 2 can detect the following errors e bar code reader was unable to read one or more bar codes on the test cards Aninconsistency was found between the information read from the button memory on the cassette and the bar codes on the test cards For example the button memory told VITEK 2 that a gram negative susceptibility card is in slot 4 of the cassette The bar code reader however found that slot to be empty The bar code reader detected a susceptibility card for which there is no inoculum Automatic dilution mode only The number of test cards in the cassette exceeds the number of available slots currently in the reader carousel There is an insufficient quantity of pipette tips or saline to process the number of cards being loaded 8 16 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors Work Flow Considerations For any type of load error the VITEK 2 instrument backs the cassette out to the Load station so that you can resolve the error If the cassette loading door is not opened withi
182. tel tel 31 411 654888 fax 31 411 654873 New Zealand bioM rieux New Zealand 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 0580 Oslo tel 47 23 37 55 50 fax 47 23 37 55 51 Poland bioM rieux Polska Sp z o o ul Zeromskiego 17 01 882 Warszawa tel 48 22 663 44 44 fax 48 22 669 99 42 Portugal bioM rieux Portugal Lda Rua do Alto do Montijo Lotes 1 e 2 2795 Carnaxide tel 351 21 424 59 80 fax 351 21 418 32 67 Russia 0 0 0 bioM rieux Petrovsko Razoumovskii proyezd 29 Stroyeniye 2 127287 Moscow tel 7 095 212 10 26 fax 7 095 214 95 41 Sweden bioM rieux Sverige AB Hantverksvagen 15 436 33 Askim Tel 46 31 68 84 90 Fax 46 31 68 48 48 Spain bioM rieux Espa a s a Manual Tovar 36 28034 Madrid tel 34 91 358 11 42 fax 34 91 358 06 29 Switzerland bioM rieux Suisse s a 51 avenue Blanc 1202 Gen ve tel 41 22 906 57 60 fax 41 22 906 57 42 Thailand bioM rieux Thailand Limited 193 52 Lake Rajada Office Complex Unit 14 A Rachadaphisek Road Klongtoey Khet Klongtoey Bangkok Metropolis 10110 tel 66 2 264 03 90 92 93 fax 66 2 264 03 91 Turkey bioM rieux Diagnostik Malz ve Hiz A S 19 Mayis Mahallesi Esin Sok Hu Ba Apt N 9 6 81090 Kozyatagi Istanbul tel 90 216 302 84 30 fax 90 216 302 84 32 United Kingdom bioM rieux
183. tes The group that does affect instrument operation is composed of the following options Find a Option Description on Cassette Names 5 5 Instrument Name 5 7 Schedule QC Status 5 8 Cassette Mode 5 10 Dilution Mode 5 11 Bar Code Reader 5 12 Table 5 1 Configuration Options that Affect Instrument Operation The VITEK 2 User s Manual 5 3 Configuration Overview Configuring the VITEK 2 Instrument The group of options that only affect the physical parameters of the user interface is composed of the following options Find a Option Description on Page Audible Alarm Enable 5 13 Audible Alarm Volume 5 14 Visual Alarm Enable 5 15 Keyclick Volume 5 16 Screen Contrast 5 17 Table 5 2 Configuration Options that Affect Only Physical Parameters When Should Configuration Options be Set Configuration options can be set or changed at almost any time However you should follow this simple work flow to ensure that you set your options correctly 1 Read the descriptions contained in this chapter for each option Evaluate the effect that an option would have on your work flow and decide how the option should be set This is especially important for the options in Table 5 1 5 4 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How Configuration Options Affect VITEK 2 2 Set the options according to the choices made in step
184. th each transfer tube The plastic tube melts causing most of it to separate from the test card and drop into the test tube The portion that remains in the test card is sealed by the melting plastic NOTE The stub left from the transfer tube may be up to 1 10 inch 0 25 cm long Test Card Incubation and Reading Once test cards are sealed they are ready to be incubated and read The test card transport system moves the boat and cassette into position for a mechanism called the card loader to place each test card into a slot on a carousel where it remains throughout the reading cycle The VITEK 2 User s Manual 4 23 What Happens Inside VITEK 2 The VITEK 2 Instrument THE CAROUSEL The Carousel pictured here has a capacity of 60 test cards During their time in the carousel the test cards are incubated at an average temperature of 35 5 C As the carousel rotates each test card moves into the reading position every 15 minutes A mechanical device called the reader head shown at the left conveys the test card through the optics stations After the reading cycle the test card returns to its slot in the carousel where it continues to be incubated until its next read cycle NOTE The carousel is divided into four sections so that it can be easily removed for periodic cleaning See Cleaning the Carousel on page 7 21 4 24 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside
185. the bar code scanner The top of the base is specifically shaped to accept a cassette Metal contacts on the base connect the unit s computer to a button memory chip on the cassette This memory chip stores the information you entered to be trans ferred to the VITEK 2 instrument O The SCS Screen The display for the SCS is a 2 5 black and white liquid crystal display LCD You use the display to view and confirm the information you are entering for the test cards and specimens The display can be tilted to allow viewing at various angles or tilted down when the SCS is not in use 9 The SCS Bar Code Scanner The SCS is 2 5 equipped with a bar code scanner The scanner facilitates data entry by substituting one bar code scan for several keystrokes The scanner can be hand held or used while mounted in its holder O The SCS Keyboard The keyboard for the 2 5 SCS has a standard set of alphanumeric keys plus several specially designed keys for SCS func tions The SCS keyboard is smaller than a stan dard size keyboard so that it can be stored under the Base Unit Component of the SCS Table 2 1 Components of the Smart Carrier Station The VITEK 2 User s Manual 2 3 The SCS Base Unit The Smart Carrier Station The SCS Base Unit The base unit for the Smart Carrier Station SCS contains the electronic components that make its data entry and storage functions possible The back panel of the base unit is w
186. tious agents 8 18 The VITEK 2 User s Manual Troubleshooting the VITEK 2 Instrument Cassette Load Processing Errors 3 Remove the card from the slot indicated in the mes sage 4 Press the PREVIOUS SCREEN key twice to exit the error queue to the Main Menu 5 Access the Resolve Bar Code Errors option on the Main Menu The following screen appears Bar Code Slot Hm Figure 8 5 Screen for Resolving Bar Code Errors 6 Using the numeric keypad enter the bar code from the bar code label Press the ENTER key The VITEK 2 User s Manual Cassette Load Processing Errors Troubleshooting the VITEK 2 Instrument NOTE The bar code you enter may be longer than the space provided on the screen When this occurs the first portion of the bar code scrolls off the display and the symbol gt appears VITEK 2 checks your entry for A valid bar code number Acard type match based on the bar code entered compared with the information read from the button memory on the cassette smart carrier only See the following section for more information If there is another bad bar code the screen in Step 5 reap pears with the new slot number Repeat Step 6 After the last bar code is entered the display returns to the main menu 7 Place the cassette back into the Cassette Load sta tion and close the door This restarts the processing cycle for this cassette 8 20 The VITEK 2 Us
187. tte and Removing Waste Processing VITEK 2 Test Cards CAUTION AN DANGER A 6 56 Leaving the door to the Cassette Unload station open will interfere with the proper processing of the test cards in the VITEK 2 instrument 4 Dispose of the materials in the cassette The cas sette can now be used to process additional test cards All of the materials in an empty cassette should be treated as biohazards and disposed of accordingly All organism suspensions should be considered as poten tially infectious Qualified laboratory personnel should use acceptable procedures for biohazardous material The VITEK 2 User s Manual Processing VITEK 2 Test Cards Unloading the Cassette and Removing Waste How to Remove Ejected Test Cards When a test card is ejected it is removed from the carousel in the Card Reader and Incubator station and placed in the Waste Collection station see Figure 6 11 This station has a capacity of 60 test cards equivalent to the capacity of the carousel How ever we do recommend that you check and empty the waste station every time you load a new cassette NOTE Once cards have been removed from the Waste Collec tion station never reinsert them This will cause the instrument to jam Figure 6 11 The Waste Collection Station REMOVING THE WASTE COLLECTION TRAY 1 Openthe waste collection station door Note that waste test cards are held in a removable tray 2 Place the in
188. ube installation and correct it as needed Press Continue to return to the Change Saline screen At the Change Saline screen press Cancel to return to the Mainte nance Menu or Done to repeat the test The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables 18 Perform the Dispenser Pipettor diagnostic test described on page 8 36 to ensure that the dispenser station is functioning properly The VITEK 2 User s Manual 7 13 Maintaining the VITEK 2 Disposables Maintaining the VITEK 2 Instrument How to Install an Accessory Kit Part B Pipette Tips NOTE If the card transport system is processing cassettes through the card transport station the following mes sage appears Card transport system is busy Please try later CAUTION Use aseptic technique when installing an accessory kit 1 Access the Change Pipette Tips function using the path Main Menu Utilities Maintenance Change Pipette Tips Change Pipette Tips About to change pipette tips Do you wish to continue 2 Press the Yes option button to continue with the pipette tip change The VITEK 2 User s Manual Maintaining the VITEK 2 Instrument Maintaining the VITEK 2 Disposables The following message appears Change Pipette Tips Proceed with adding pipette tips Done F Cancel 3 Open the fron
189. us 5 22 Option box Cassette Mode 5 24 Dilution Mode Bar Code Reader Audible Alarm Visible Alarm Set range Audible Alarm Volume 5 25 value Keyclick Volume Screen Contrast Table 5 3 Types of Interfaces for Configuration Options The VITEK 2 User s Manual Configuring the VITEK 2 Instrument How to Set VITEK 2 Configuration Options Where to Find the Configuration Options All of the configuration options for VITEK 2 are on the Config uration Menu You access this menu using the path VITEK 2 Main Menu gt Utilities Configuration The VITEK 2 Main Menu looks like this Display Instrument QC Status Cassette Setup Batch Load Utilities Resolve Bar Code Errors The VITEK 2 User s Manual 5 19 How to Set VITEK 2 Configuration Options Configuring the VITEK 2 Instrument How to Define Character Sets Use this procedure for the Cassette Names and Instrument Name configuration options Character sets can include any of the characters provided on the character selection plus the 10 digits from the keypad 1 Select the Cassette Names or Instrument Name configuration options using the path Main Menu gt Utilities Configuration For the Cassette Names option the following screen appears Cassette Names 5 NM CO O 1 O 0 Enter the user number to add or modify
190. when all the cards have been entered for the Cassette Instrument Diagnostics Some of the error recovery procedures in this chapter ask you to perform a diagnostic test on one of the stations in the VITEK 2 instrument This section tells you how to access and use those tests Instrument Diagnostics Menu All of the diagnostic tests for the instrument are located on the Diagnostics Menu which can be accessed using the following path Main Menu gt Utilities gt Diagnostics The VITEK 2 User s Manual Instrument Diagnostics Diagnostic Tests Troubleshooting the VITEK 2 Instrument Following are the tests found on the Diagnostics menu and their function Diagnostic Test Function Possible Results Temperature Optics Card Transport Vacuum Dispenser Pipet tor Error Message Log Reads the temperature in the reader carousel Performs a self test of the transmittance and fluores cence optics systems Performs a self test of the Card Transport system Performs a vacuum test of the Filler station Performs a saline dispens ing and a simulated organ ism suspension transfer Stores all errors messages occurring since the power was last turned on When you power off the VITEK 2 all messages and errors are deleted from this log Displays the carousel temperature in degrees Celsius Also displays the word LOW or HIGH if the temper ature is out of specifi
191. xn u lNolq 82 S nunuo2 uiejqoud eui j S 9g g eBed uo einpeooud eui ees jeet onsouDeip jojedig jesuedsiq eui Le pue 480 eseq y ojuo U llE Aew ey Schu n did jo e2uesaud y 40 YOOUD Cy L Z uo 501 n did 901d oun S y 5 Mau e 21941 J Z 1002 Jeurejuoo aui ui sd jo y 40 pue JOOP ss9ooe 1u0JJ v u do L em re4 Jonedig Sulss ooid 1011 Sunposoag AADI a qu 4940224 PUD ASVSSaP 40445 c g QPL 8 69 The VITEK 2 User s Manual eouelsisse 10 Xn L VNOLQ eo snoeJ l lqold eui urepe 1591 ou Duisseooud 19 nduuo2 uonejsxy0 y ye 4 AHU Jaueg eu u peJojue u q seu pJeo 1S eui 18 ens YE N 1015 1 dAL pied uxouyun SISSE JO 10 22 senunuoo 15 uejqoJd eui OL G uo einpeooJud ees n ssepo 1991109 OU Ul SI JUBLUNJISU Z vi UA ul 1eui ens oye pessoooJd u q snorA2ud seq yey uonpuuojur sureuo iourouu SOS e 9 19SSEO y JO y 4 lu H uoynq y ui gep eui eseJe o 013 eui SS ld SOS 94 uo ejesseo eui nd
192. y work flow Some affect only the physical interface and can be changed to suit your preferences For example you can adjust the contrast on the interface screen Other options affect how VITEK 2 processes test cards Therefore careful consideration should be given to setting or changing these options Where to Find It Configuration Overview 5 3 What are the Configuration Options 5 3 When Should Configuration Options be Set 5 4 How Configuration Options Affect VITEK 2 5 5 Cassette Names 5 5 Instrument Name 5 7 Schedule Instrument QC Status 5 8 Cassette Mode 5 10 Dilution Mode 5 11 Bar Code Reader 5 12 Audible Alarm Enable 5 13 Audible Alarm Volume 5 14 Visual Alarm Enable 5 15 Keyclick Volume 5 16 Screen Contrast 5 17 The VITEK 2 User s Manual 5 Introduction 5 2 Configuring the VITEK 2 Instrument How to Set VITEK 2 Configuration Options 5 18 Where to Find Configuration Options 5 19 How to Define Character Sets 5 20 How to Set Time for the QC Status 5 22 How to Use Option Boxes 5 24 How to Set a Range Value 5 25 The VITEK 2 User s Manual Configuring the VITEK 2 Instrument Configuration Overview Configuration Overview What are the Configuration Options There are 11 configuration options in the VITEK 2 user inter face They can be divided into two groups depending on whether or not the option affects how the instrument opera
193. ystem All process phases 4 29 The VITEK 2 User s Manual 4 9 4 What Happens Inside VITEK 2 The VITEK 2 Instrument The Smart Carrier Station SCS The Cassettes DANGER A 4 10 The SCS is not a part of the VITEK 2 instrument but it is the station where the entire process begins For complete details on the SCS see Chapter 2 The Smart Carrier Station The cassette should be considered as potentially contami nated and should be handled appropriately Qualified labo ratory personnel should take the usual precautions necessary for infectious agents The cassette is the main component of the test card transport system It can hold up to 15 test cards with their inoculum test tubes In systems utilizing the Smart Carrier Station the button memory chip on the cassette is used to store and transport data from the Smart Carrier Station to VITEK 2 The VITEK 2 User s Manual The VITEK 2 Instrument What Happens Inside VITEK 2 Test Card Slots The top portion of a cassette is divided into 15 test card slots that can hold various combinations of VITEK 2 test cards O Test Tube Holders The front portion of a cassette has 15 wells into which you place test tubes for inoculum Test Tube Release Test tubes are held securely in the cas sette by a retaining bar A release lever is provided for easy disposal of used test tubes O Button Memory For systems utilizing a Smart Carrier

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