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VITAL SCIENTIFIC N.V. - Frank`s Hospital Workshop

1. sese 4 7 4 1 8 Request controls calibrators and blank determinations 4 7 4 1 9 Delete a request 4 8 4 1 10 Print a work list nuna 4 8 4 2 Load the sample rotor and start the tests 4 9 4 2 1 LOAD SAMPLES u sidi 4 9 4 2 2 Load the sample rotor sen 4 11 4 2 3 Load samples with barcode 4 12 4 2 4 REAGENTS INFO Men 4 12 4 2 5 Start the analysis run tase st A kapa 4 13 c VITAL SCIENTIFIC N V VITALAB ma 000 a a 4 3 Checking and validating results u 4 15 4 3 1 Evaluate Samples menu 4 15 4 3 2 Test Displays Graphic mode Table 4 17 4 3 3 Automatic Results Printout 4 23 4 3 4 Validation of a dee cM 4 24 5 Extended ROUNE i ei l tal anal 5 1 5 1 Quality Control E an Raai 5 2 5 1 1 Start Quality Control 5 2 5 1 2 Graphic Representation of Quality
2. 5 3 5 2 Program COMMONS 5 5 5 2 1 Start PROGRAM CONTROLS 5 5 5 2 2 PROGRAM CONTROL Parameters eese eese en nena innt 5 5 5 2 3 Program Controls Display Fields silikati ia ei i 5 5 5 2 4 To Enter a control and assign the control to a number of tests 5 6 5 2 5 Assign a control to a cut off test uus rena bie i kid ee bene i ad ee 5 6 5 2 6 Delete the assignment between a quality control and a test 5 6 5 2 7 To change or delete a control e g when the batch lot number e eda f L n ua kausa suet 5 6 5 2 8 Westgard RUNS bet kata 5 7 5 3 Programming Calibrators 5 8 5 9 1 Program a Calibrator ap kebbes 5 8 5 4 Programming Test Parameters 5 10 5 4 1 TEST PROGRAMMING Parameters nn 5 10 5 4 2 Program Test Parameters u 5 11 5 5 Calibrator parameter definition 5 19 5 5 1 Program Calibrator Parameters rtr er etd Soie tiores 5 19 5 5 2 CUt Off testi 5 20 5 5 3 Calibration Curves
3. Press F7 in the MAIN MENU or in the LOAD elle leon teen oe m m SAMPLES menu to select the EVALUATE amp K B lt 4 ds zl 1 SAMPLES menu Depending on the type of test Rs The CM Tom sexe Mem you can choose between screen of the calculated absorbances in tabular or graphic form Parameters on left side of screen Sample Number The sample number as defined in the REQUEST SAMPLES menu Sample Name The sample name as defined in the REQUEST SAMPLES menu Date of birth The patient s date of birth is shown here if it was entered in the REQUEST SAMPLES menu Physician name The name of a physician in charge is shown here if it was entered in the REQUEST SAMPLES menu Sample Type The sample type Normal Pediatric Control etc Sex The sex of the patient M male F female or P pediatric Status The current processing status of the sample is shown in the status field directly behind Sample Type The status field shows the position and the status of the samples on the sample rotor The following status indications are possible e In Process The sample or at least one of its allocated tests is currentiv being processed i e the result of at least one test is pending e Cancelled The sample was loaded but the request was cancelled The sample will not be processed and subsequently no results will be calculated e Ready The sample has been processed The resu
4. 77 vital scientific VITAL SCIENTIFIC N V VITALAB Preface CE This instrument conforms to the provisions of the EU Directive on In Vitro Diagnostic Medical Devices 98 79 EC of the European Parliament and the Council of 27 October 1998 The contents of this manual with all figures tables and graphics are intellectual propertv of Vital Scientific Unauthorised commercial or non commercial excerption or copving of contents and use of this manual in total or in parts are strictly forbidden unless the editor gives written permission for it This manual was written and produced with the utmost care However errors cannot be fullv excluded Vital Scientific do not take anv responsibilities and accepts no liabilities for incidents of anv kind that mav occur because of errors in the manual All product names are mentioned in this manual are registered trademarks The manual describes the analvser svstem Vitalab Selectra E and the new software version June 2003 Please call Vital Scientific if you need advice or you have any questions Manufacturer Vital Scientific N V PO box 100 NL 6950 AC Dieren The Netherlands Telephone 31 313 430 500 Telefax 31 313 427 807 e mail info vital nl Internet www vital nl Article No 6002 160 410 05 VITAL SCIENTIFIC N V Table of contents 1 Safety Precautions and Potential Hazards
5. 5 21 5 6 Needle Cuvette Incompatibility 5 22 5 6 2 Display of Incompatibilities 5 22 5 6 3 Define 5 23 5 6 4 Define Linked tests 5 23 5 24 5 7 1 Program PROFILES lk bake i 5 24 58 Reagent POSION Waska asss samak teeny ns 5 25 5 8 1 Program a REAGENT POSITION i ir i 5 25 5 9 Calculated Results El 5 27 5 9 1 Program Calculated Results ib G a jab ki 5 27 5 10 Error Flags and Messages bkabu 5 30 VITAL SCIENTIFIC VITALAB 6 Special TU lOS ai ss a a i B eet 6 1 6 1 Select printers and set host connection 6 2 6 2 Set Up a a e ak RE Ga 6 3 oscura a St 6 4 6 3 1 Defective mixer 4 Imm 6 4 6 3 2 Sample needle 18 3 21912 8 ika be ts 6 4 6 3 3 Removal of rotor WAY i ieee tees 6 5 6 3 4 Error e 6 5 6 3 5 Error code lis U 6 6 6 4 Maintenance 6 15 6 4 1 User Maintenance emen 6 15 6 4 2 Replace measurement 15 6 16 6 4 3 Manual Cuvette Rotor Blank Me
6. 3 4 KNIE OM S RUNE RETE 3 5 9 5 MeSS89682 ae oe ee eee eee ener eee ee ee H 3 5 3 2 Start the analyzer for the first time eene rennen entente 3 5 3 2 1 Prepare the analyzer 3 5 3 2 2 Start the AN TEES 3 6 3 2 3 Set the System 3 7 3 2 4 Set the Run Mode U eene nnne nnne nnns 3 9 3 2 5 Install the Cooling Unit 3 9 3 2 5 Fil Remove System Liquid i e 3 10 3 2 7 Operation Prerequisites 3 11 3 2 8 Checklist for Routine Operation 3 13 4 arida c 4 1 4 1 Entering sample data and test 5 sse 4 2 4 1 1 Requests Samples 4 4 2 4 1 2 Manually enter samples and test 4 4 4 1 3 Read samples and tests with barcode 4 5 4 1 4 Do test sequence in repeat mode 4 5 4 1 5 Request test profiles eerte rre 4 6 4 1 6 Request a Stat sample with barcode 4 6 4 1 7 Request a pediatric
7. gt Parameters Control fields left hand All controls in PROGRAM CONTROL max 15 are displayed in grey side of screen controls connected to a selected test are displayed in black Display fields right hand All programmed tests max 55 are displayed All tests connected to the side of screen selected control are displayed in black All controls connected to a selected test are shown in black on the left hand side of the screen Function Keys F1 PRINT PRINT ALL Prints the current display The format can be either graphical of table F2 TABLE GRAPHIC MODE The analyzer moves from the GRAPHIC to the TABLE mode Press F2 GRAPHIC MODE to return to the graphic mode This function is available when in TABLE MODE F3 NxT PRV TEST Selects the graphic representation of the next F3 or the previous SHIFT F3 test of the current control F4 PROGRAM CONTROL Changes the assignment of tests and controls in PROGRAM CONTROL F6 GRAPHIC NORMAL MoDE When in QUALITY CONTROL the results from selected control test combination are displayed in graphic format This function is available for valid control test combinations When in GRAPHIC MODE F6 returns to QUALITY CoNTROL The last 30 measurements are available F7 EVALUATE SAMPLES Goes to the EVALUATE SAMPLES menu F8 REQUEST SAMPLES Goes to the REQUEST SAMPLES menu F9 LOAD SAMPLES Goes to the LOAD SAMPLES menu F10 MAIN MENU Returns to MAIN MENU A 5 2 VITAL SCIENTIFIC N V VITA
8. see below see below VITAL SCIENTIFIC N V VITALAB Detailed info for mono mode for kinetic K 22 times used i 1 point i 6 for twopoint T 22 times used i 1 point i 6 for endpoint monochromatic M endpoint 1 6 endpoint 2 6 for endpoint bichromatic B endpoint 1 6 endpoint 2 6 for ISE I Detailed info for dual mode for kinetic K 21 times used i 1 point i 6 for twopoint T 21 times used i 1 point i 6 for endpoint monochromatic M used abs 1la 1 endpoint abs 1 6 used abs 1b 1 endpoint abs 1b 6 used 1la 1 endpoint 1a 6 used ep 1b 1 endpoint 1b 6 used ep 2a 1 endpoint 2a 6 used ep 2b 1 endpoint 2b 6 38 times for endpoint bichromatic B used abs la 1 endpoint abs 1a 6 used abs 1b 1 endpoint abs 1b 6 used 1la 1 endpoint 1a 6 used ep 1b 1 endpoint 1b 6 used ep 2a 1 endpoint 2a 6 used ep 2b 1 endpoint 2b 6 38 times for ISE I used i 1 0 point i not used 1 point i used for computation VITAL SCIENTIFIC N V 42 times 42 times 44 times 2 times 2 times 44 times Appendix STOA 8 5 Flags These flags appear in a fixed order in a string For every flag either a space is written or the respective flag If none of the flags is true a string is sent with 22 spaces VITALAB pos
9. Minimum PC Requirements CPU Intel Pentium 133 MHz RAM 32 MB Monitor VGA Monitor 640 x 480 pixel Hard Disk 1 GB Floppy Disk drive 3 5 1 44 MB Additional drive CD ROM drive Operating system Windows 98 Second Edition or 2000 Serial ports 1 for analyser 1 for host 1 for printer 2 Parallel port 1 for printer depending on options used Cooling unit Weight empty 19 6 kg Weight filled Approx 23 kg Required space 84 cm2 Dimensions cm 24W x 37H x 35L Coolant 3 5 glycol based System Closed circulation Connection Mains connector Power consumption 340 VA max At operating voltage 110 or 230 VAC device dependent Line frequency 50 60 Hz Barcode reader Version Hand device Technology CCD Barcodes UPC A 2 5 UPC E 2 5 EAN 13 2 5 EAN 8 2 5 Code 39 Code 93 Code 128 Codabar VITAL SCIENTIFIC N V Code 2 out of 5 Code 2 of 5 interleaved MSI Plessey 2 13 Introduction VITALAB Note 1 Accuracy and precision The chemical performance of clinical chemistrv analyzers in terms of accuracy and imprecision depend on the following the characteristics of the instrument the measurement techniques and the materials used Therefore the chemical performance characteristics of a clinical chemistry analyzer can only be established and postulated in terms of the analyte the specific reagent kit and calibrator s used the type and constitution of the specimens involved etc The Vitalab analyzers are desi
10. Note Check the loaded reagents and their volumes before you start the analysis run Counter mode and Normal mode Press F5 COUNTER MopE to show the internal lab statistics The Counter mode shows the total number of processed samples per method in both run modes After changing from one mode to the other also the test count indication changes Press F5 NORMAL to return to the Normal mode Press ALT F3 to delete the statistics and to reset all counters to 0 F7 ii Eval Samples Confirm Refill Normal Counts Mode Load Samples Request Samples 4 2 5 Start the analysis run 1 Place all samples standards controls etc in their correct position on the sample rotor 2 Make sure there is a sufficient amount of reagents available for all requests 3 Press CONFIRM LOAD to start the analysis run The positions which are currently being processed are not shown in the screen As soon as a sample has been processed the position is shown in inverted mode on the screen Note Do not change to another menu except REAGENT INFO before pressing otherwise all position definitions for the sample rotor are lost Start from standby mode If starting from the Stand by mode i e no other requests are currently being processed the analyzer will first switch on the lamp and the vacuum pump and rinse the cuvettes Messages will inform you if any u
11. Use the Save before clear option in SYSTEM PARAMETERS if you want all results to be saved to disk Only tests programmed in the TEST PROGRAMMING menu can be assigned a reagent position 5 8 1 Program REAGENT POSITION 1 Select from the MAIN MENU F5 SPECIAL FUNCTIONS F2 INSTALLATION 2 Select REAGENT POSITION DUAL MODE or REAGENT POSITION MONO MODE 3 Press ENTER The cursor moves to the selection field for the 32 reagent positions All test results stored in the main memory are deleted The message ALL RESULTS HAVE BEEN CLEARED is displayed 4 Select an empty rotor position and press ENTER 5 Select the required reagent for that position from the list and press F4 Select go condone Reagent 1 6 Place the bottle with the 1 in the re rotor at that position Commuricaien Report Set Up 7 Select the next empty rotor position and press ENTER 8 Select the same reagent and press e 50 select Reagent 2 e 70 select Dummy 1 e F8to select Dummy 2 VITAL SCIENTIFIC N V 5 25 Extended Routine 9 Place the bottles for each reagent and dummy reagent in the correct position on the rotor Keys TAB CURSOR KEYS ENTER F1 PRINT F3 DELETE POSITION F10 SPECIAL FUNCTIONS F4 SELECT REAG 1 F5 SELECT REAG 2 F7 SELECT DUMM 1 F8 SELECT DUMM 2 5 26 VITALAB HCI OIN NEEDLE RINSE F3 F4 F5 F10 Rw 4 Delete Select Select Retum Pos Reag1 Reag2 From the men
12. e Load Samples Return 5 24 VITAL SCIENTIFIC N V VITALAB Extended Routine 5 8 Reagent Position Note When you change to the right half of the screen pressing TAB or ENTER the analvzer deletes all results in the F7 EVALUATE SAMPLES menu from the main memory without confirmation They will only be saved to disk if option Save Before Clear was selected in SYSTEM PARAMETERS After the test parameters are programmed the necessary reagents must be assigned to positions on the reagent rotor This is done in the INSTALLATION menu Please note the difference between the Dual Mode and the Mono Mode If you move between both modes program each reagent position separately It is recommended to use separate reagent rotors with separate bottle positioning for the two modes If the mode is changed it is then only necessary to replace the respective reagent rotor A table represents the 32 positions of the reagent rotor When reagents are assigned the test names are displayed on the corresponding positions A superscript capital D in front of the reagent name indicates a sample blank reagent superscript 2 in front of the reagent name indicates a second or starter reagent If you wish to change an occupied reagent position the analyzer will automatically delete all results that are currently stored on the main memory for that position If you wish to occupy a free position using new reagent no results will be deleted
13. the system the corresponding result will be marked with a flag The percentage minimum or maximum ratio depending on the selection in Prozone check of the two absorbance values or delta absorbances calculated by the system If this value is exceeded the analyzer detects a prozone error and marks the corresponding result with a prozone flag The default setting is 80 The other prozone parameters are entered on pages 2 DUAL MODE and 3 MONO MODE and are described there The low limit of the reference range for male samples If a measured value is below this limit the analyzer flags the result The high limit of the reference range for male samples If a measured value is above this limit the analyzer flags the result The low limit of the reference range for female samples If a measured value is below this limit the analyzer flags the result The high limit of the reference range for female samples If a measured value is above this limit the analyzer flags the result The low limit of the reference range for pediatric samples If a measured value is below this limit the analyzer flags the result The high limit of the reference range for pediatric samples If a measured value is above this limit the analyzer flags the result The low panic limit of the reference ranges for all types of samples If a measured value is below this limit the analyzer flags the result on the printout if the report set up is enabl
14. 1 1 InEECI I C PEEEEMLAMMT 1 2 1 1 1 Disclaimer 1 2 1 1 2 Operator Qualification n 1 2 1 1 3 Service Technician Qualification nee 1 2 12 Descriptiorof symDbols 1 3 1 2 1 Symbols on the instrument u 1 3 1 2 2 Symbols in the manual a B 1 3 1 3 FlazardS u ARJA PA QURE EE Ve ER ERR x TA l 4 1 3 1 Electrical hazards nn l 4 1 3 2 Mechanical hazards a nennen nnne l 4 1 3 3 Sample and Reagent arms a 1 4 PI 1 4 1 3 5 Chemical hazards ei a a eh eet l 4 1 3 6 ja kk 1 5 1 4 Installation and maintenance 4 1 6 1 4 1 External connections 1 6 1 4 2 uu uuu uu ua usu nn rrr 1 6 1 4 3 Instrument Unused for a Long TIME nn nnnnnn nn mnn 1 6 1 5 Use of materials with the 1 7 l SAl Specimjien e ER 1 7 1 5 2 C m 1 7 1 5 3 Reagents arid callBratOrs isse La deo bis Co 1 7 AU aom 1 7 1 5 5 Disclaimer nico BEER ERR RR 1 7 Su u n p u S Sa A sz a h b
15. Control Requests that are recognized by the analyzer as controls You can place controls in the positions C1 to C4 and in any position available for patient samples e Calibrator Calibrate tests as described in the respective method sheets You can place Calibrators in the positions S1 to S9 and in any position available for patient samples e Blank One position on the inner ring of the rotor is reserved for the reagent blank measurement It is recommended to carry out a daily blank measurement for methods that require a reagent blank The screen shows a variable number of tests The number depends on the programming made in the TEST PROGRAMMING menu The maximum number of tests is 32 You can program the tests in the TEST PARAMETERS menu In the REAGENT POSITION menu you can define the test for the current reagent rotor Move inside an entry field from one position to the next Move the cursor to the next or previous field Switch between left and right fields e Select or deselect a test from the test display e Moves the cursor from one field to the next Print a list of all data in the request buffer 4 3 Basic Routine wass C F2 STAT F3 PROFILE F4 REPEAT MODE F5 PREV SAMPLE F6 FORWARD SAMPLE SHIFT F7 DELETE ALT F7 DELETE ALL F8 NEW SAMPLE F9 LOAD SAMPLES 4 1 2 T Note VITALAB Mark the sample request currently shown on the screen as an emergency sample A window with all profiles for the current ru
16. Digoxine C Qualitrol HSN 451 C Qualitrol HSP 452 27032001 003 Eliza Scott 27032001 004 Peter Oakfield 27032001 005 Randolph Smith 27032001 006 Yvette van Lier 27032001 007 Jean Austin 27032001 008 Patrick O Donald Tests requested AST GGTS UREA CREA UREA Na K Cl DIGO AST CHOL CREA Na K cl Na K cl UREA DIGO AST CREA GGTS TBIL UREA DIGO AST GGTS GLUC Na K cl CHOL UREA DIGO VITAL SCIENTIFIC N V VITALAB Basic Routine 42 Loadthe sample rotor and start the tests 4 2 1 LOAD SAMPLES menu The LOAD SAMPLES menu F9 contains all functions for loading the sample rotor and starting the sample processing Vou can place the programmed samples in anv position on the outer two rings of the sample rotor Vou can also load and start Stat samples controls standards and pediatric samples As soon as a sample has been processed the instrument indicates the new status of the sample Diana Johnson Precinorm U 199451 Vou can place a new sample in the sample rotor as soon as the processed sample has been removed The analvzer will automaticallv analyze the new sample You can also use the 1 lt gt ii LOAD SAMPLES menu to check the volume of ad s ee gt m it T the loaded reagents and to refill liquids if necessary Sample rotor parameters The screen shows the sample rotor with all positions and their current processing status The following displa
17. HCI and 6 times 32 ul washing solution VITAL SCIENTIFIC N V 4 9 Basic Routine kas s l C ISE VITALAB When the optional ISE unit is connected this position is used for the ISE activator human serum Other parameters on right side of screen Entry Field Display Fields Keys F1 LoAD LIST F2 SELECTIVE UNLOAD F3 CONFIRM LOAD F4 CONFIRM UNLOAD F5 REAGENT INFO F6 QUALITY CONTROL F7 EVALUATE SANPLES F8 REQUEST SAMPLES F10 MAIN MENU 4 10 Enter the sample number of the requested patient sample You can also record the barcode labels on the sample tubes with a barcode reader The tube positions are determined by the sequence of entries The analyzer shows all samples in the request buffer The requests of special sample types are listed first blank calibrators emergency pediatric Subsequently all normal samples and controls are listed in the order in which these were requested Print a load list when the loading is ready and the analysis run was started with F3 CONFIRM LOAD Unload specific samples that are ready e g all controls or all normal samples Then you can place a new sample on the emptied positions If you press F2 a menu is shown Here you can select which type of samples must be unloaded Start the analvsis run after vou have placed all samples in the sample rotor When samples have been processed vou can remove them from the sample rotor Confirm this with F4 before loading a ne
18. Keys F10 Go to the SPECIAL FUNCTIONS menu 3 8 VITAL SCIENTIFIC N V VITALAB System Handling Basics 3 2 4 Set the Run Mode Note m All existing requests are cancelled when you change the run mode The reagent positions must be defined separately for both modes Also the result memory is cleared when changing modes Stand by DUAL Req tray buffer 0 0 Reagent Disc ROUTINE Run mode 1 Select F5 SPECIAL FUNCTIONS F2 INSTALLATION 2 Select Run Mode 3 Press ENTER or TAB gt Run mode Reagent Position DUAL MODE Quality Control Evaluate Samples Request Samples Load Samples jont forget to change the reagent disc Reagent Position MONO MODE programmed at Reagent Position for other model System Parameters ISE Parameters c AS Report Set Up Alt FS Keys ALT F9 Toggles between Run Mode F10 Go to the SPECIAL FUNCTIONS menu 3 2 5 Install the Cooling Unit i Caution m Check the cooling unit for the correct voltage before you connect the cooling unit Never let the cooling unit pump run dry because this will damage the pump The additional external cooling unit of the analyzer guarantees necessary cooling for loaded reagents The cooling unit operates with a sealed cycle technology The cooling unit requires virtually no maintenance Unit and coolant are free from CFC Fill the unit with coolant and demineralised or distilled water before you put the analyzer in op
19. MODE 422 sec MONO MODE Press ENTER select a value and press ENTER again to confirm If gt 0 was entered for the reagent 2 bottle in the field normal volume the values refer to the time after reagent 2 was added If not then the values refer to the time after the sample was added Proz pt one two If an absorbance ratio or delta absorbance ratio were selected in the field Prozone check Screen Page 1 Test Parameters the field Proz point 1 2 is displayed here Press ENTER to open a drop down list select the time in seconds for the measurement of the first prozone point and confirm with ENTER Repeat for the second point in the other field 5 16 VITAL SCIENTIFIC N V VITALAB Proz H Limit Linearitv Limit Factor Reagent blank 1j Low Absorbance High Absorbance VITAL SCIENTIFIC N V Extended Routine O If an absorbance ratio or delta absorbance ratio were selected in the field Prozone check Screen Page 1 Test Parameters the field Proz H Limit is displayed here Enter a high limit in form of an absorption or delta absorption per minute and confirm with ENTER If this limit is exceeded the analyzer displays a prozone error This limit is used to detect a linearity error for the first four measurements points and to evaluate the additional measurement points of a kinetic test that can be accepted for evaluation The default value is 10 For methods that do not require calibration the multiplicat
20. Regularly check the liquid level visually System parameters Select the INSTALLATION menu RUN MODE submenu Make all necessary settings Change the parameters in the SYSTEM PARAMETERS accordingly if another printout is required or if a host computer is connected to the analyzer first installation and as needed Liquid system Fill the liquid system of the analyzer with system liquid when the system is ee put into operation for the first time Use the FILL EMPTY SYSTEM menu first installation Programming calibrators Program the calibrators to be used by the system in the CALIBRATORS menu first installation and as needed Programming controls Program the controls in the CONTROLS menu first installation and as needed VITAL SCIENTIFIC N V 3 11 System Handling Basics C Programming test parameters first installation and new parameters Incompatibilitv of tests first installation and new parameters Reagent positioning and reagent volume dailv and as needed Programming profiles as needed Water Waste container dailv Cuvette blank measurement dailv Sample preparation and safetv precautions dailv 3 12 VITALAB Load or program all parameters that are regulariv used the analvzer Use the TEST PARAMETERS menu This also applies to new tests that must be added The programming instructions e g test method volumes units etc are explained in the method she
21. SCIENTIFIC N V VITALAB Basic Routine 4 3 2 Test Displays Graphic mode and Table mode Press F2 GRAPHIC TABLE MODE to show the results in detail A separate prozone graphic and a prozone table can be called up if a None Ham Ubech EF prozone check was defined for a method in the im SRM E TEST PROGRAMMING menu A maximum of 32 results including blanks are 57 qs shown for each sample left hand side of LOC screen The current test and the respective T iim unit are shown above the table the graphic Chen WT The screen also shows the status of the test GGT 447 WAITING FOR YOUR DECISION F3 F6 REAGENT ABSORBANCE LIMIT ERROR ASAT GOT 331 Calcium 033 Total bilirubin Total bilirubin INFO Ak Phosphatas 156 Creatinine 89 8 GT 2Digoxin CReactive pio 1 CKNAC 1 VITAL SCIENTIFIC N V 4 17 Basic Routine kas s l C Parameters Status Graphic mode Table mode 4 18 VITALAB The status Waiting For Your Decision is shown if the word INFO is shown next to a result Depending on the shown error message e g Insufficient Sample or Absorbance Limit Error the user may now either accept the result reject the result repeat the measurement or rerun the test with a specific rerun volume Chapter 5 contains a list of possible error messages The x axis of the graphic is the time axis The x axis shows the kinetic measurement points in relation to the time
22. To calculate the absorbance the analyzer has used the two points measured after the first reagent was dispensed R4 minus R gt and the two endpoints after an incubation time of 11 5 min E minus E3 Press F2 to go to the table mode The example shows a table with the result of the calculation at the top the absorbance value The calculation is a bichromatic endpoint calculation and the result has already been corrected for the reagent absorbance The column R shows the results of the reagent absorbance measured for 546 and 620 nm The two remaining columns E show the results for the two endpoints measured with the respective delay at 546 and 620 nm The arrows mark all points that are used for the calculation depending on the programming made in the TEST PROGRAMMING menu VITAL SCIENTIFIC N V Stand by fain Menu Special Functions Rotor System ISE Installation Sample Number 123 444 cholesterol Programming Sample Name John Brown READY Eod Datecfbith 27 11 1974 Sex M Physician name Sample Normal READY 1 GGT 2Digoxin e el DUAL Reg Aray buffer0 5 Reagent Disc ROUTINE EvalSamples Graphic 10 0210 19JAN 2007 build O S9 61 lain Menu Special Functions Rotor System ISE Installation B Stand by Sample Number 123 444 cholesterol Sample Name John Brown eee Date of birth 27 1 1974 M Physician name Sample Type Normal
23. a quality control and a test 1 Selectthe test from the test list of the Program Control screen 2 Press F3 DELETE TEST 5 2 7 To change or delete a control e g when the batch lot number has changed 1 From the MAIN MENU select F6 QUALITY CONTROL F4 PROGRAM CONTROL 2 Select SHIFT F2 EDIT CONTROL to edit the displayed control or SHIFT F4 DELETE CONTROL to delete it without confirmation 5 6 VITAL SCIENTIFIC N V VITALAB Extended Routine Caution The existing results of the qualitv control are lost if the control is changed or deleted 5 2 8 Westgard Rules The Westgard rules used on the analvzer are valid for single controls Thev evaluate the qualitv controls according to the following rules e f 1 result of the control is outside standard deviations the Westgard rules are broken e Ifthe last 2 control results exceed 2 standard deviations in the same direction or the Westgard rules are broken e fthelast 4 control results exceed 1 standard deviation in the same direction or the Westgard rules are broken e fthelast 10 control results are all located either on the or the side to the mean the Westgard rules are broken e f one test result of the control is within 2 standard deviations the Westgard rules are not broken The Westgard rules are not violated in all other cases VITAL SCIENTIFIC N V 5 7 Extended Routine VITALAB 5 3 Programming Calibrators Calibrators mu
24. does not depend on current system operation The status line shows following information e Status of the analyzer e g Stand by e Run Mode Mono Mode or Dual Mode e Request Buffer information about the number of samples that is requested but not yet loaded e Tray Buffer information about the current number of sample tubes loaded into the analyzer e Reagent disc Name of the selected reagent disc e Display mode the menu in which you are currently working e g MAIN MENU e Time and date e The state of the external interface RS 232 e g On line Input area To input data and to select the functions and menus use the keyboard or mouse To read the sample labels and tests on the barcode tray use the barcode reader Function Keys F1 to F10 Information of the specific function of the function keys is on constant display on the monitor All displays have a common structure with the Function Keys at the bottom of the monitor 3 4 VITAL SCIENTIFIC N V VITALAB 3 1 4 Keys ARROW KEYS TAB PAGE Up Down HOME END ENTER 1 10 ALT F10 SPACEBAR Go to another field Switch between left and right fields Scroll through a list Confirm entry Function keys Emergency halt Select or deselect a checkbox System Handling Basics SS umami Note a To stop the whole analvzer press ALT F10 simultaneously This emergencv stop is always possible The analvzer goes to the Halted state and all current measure
25. flag error 1 G general hardware error 2 R insufficient reagent 3 insufficient sample 4 L lamp error ISE electrode not calibrated 5 U underrange underrange ISE electrode 6 O overrange overrange ISE electrode 7 u underrange reference counter underrange reference ISE electrode 8 o overrange reference counter overrange reference ISE electrode 9 T cuvette temperature error ISE temperature error 10 r rerun 11 linearity error 12 M absorbancoe limit violation 13 D reagent absorbance deviation error 14 westgard violation 15 A calibrator limit violation 16 C control limit violation 17 N reference limit violation 18 a reagent absorbance limit violation 19 general ISE unit error 20 X concentration limit error 21 P prozone error 22 E result near cut off Limit flags These flags appear in a fixed order in a string For every flag either a space is written or the respective flag If none of the flags is true a string is sent with 3 spaces 8 6 pos flag error 1 H general hardware error 2 IL insufficient reagent 3 insufficient sample SSS s VITAL SCIENTIFIC N V VITALAB Appendix Message Reagent installation Direction analyzer host Format STX I device id 4 test name 4 32 times CR LF Explanation This message is sent automaticallv bv the analvzer PC when the operator has changed the reagent installation the run mod
26. high infinity signs on the intensity bars in the LAMP ADJUSTMENT menu E14 CUVETTES TEMP ERROR Select F1 CHECK AGAIN Inform the service technician if the error occurs again E15 REAGENT NEEDLE TEMP ERROR Select F1 CHECK AGAIN Inform the service technician if the error occurs again E16 CONCENTRATED WASTE The CONC WASTE FULL signal Empty the optional concentrated waste container 6 10 FULL is high for 1 second or longer only if the optional container is Check if the concentrated waste installed container floating switch is working properly Check the wiring EG VITAL SCIENTIFIC N V VITALAB Special functions Error message Cause Action E17 INSUFFICIENT WATER The lower level detector detects No water in the water container Check if there is enough svstem liquid in the container and refill if necessary Check if the liquid tubing is leaking or if it is blocked and repair if necessary Check if the filter in the container is blocked and replace if necessary Service personnel only Check if the system liquid level detection circuit is working correctly and repair if necessary E20 SAMPLE SYR POS ERROR E21 SAMPLE SYR POS ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET Inform the service technician if the error occurs again E22 SAMPLE VALVE ERROR Press either F5 SPECIFIC RESET or select SHI
27. is displayed for the positive or negative result 5 Enter the values for Target Low Limit High Limit Westgard Active 6 Press F10 RETURN to return to the PROGRAM CONTROLS screen The same screen can be activated from within the QUALITY CONTROL menu by pressing F4 PROGRAM CONTROL However this should only be done if a name and batch number have already been assigned to the control Function Keys F1 PRINT Print out a list of all tests assigned to the current control SHIFT F2 EDIT CONTROL Place the cursor in the field NAME Select Edit Control You may now enter a new name and or batch number for that control All test assignments to the current control are deleted F3 DELETE TEST Deletes the assignment of the test to the current control SHIFT F4 DELETE CONTROL To delete the current control There is no confirmation and all the related quality control test results are also deleted VITAL SCIENTIFIC N V 5 5 Extended Routine VITALAB Gw F10 RETURN Goes back one screen to either QUALITY CONTROL or PROGRAMMING All changes made are saved 5 2 4 To Enter a control and assign the control to a number of tests 1 From the MAIN MENU select F5 SPECIAL FUNCTIONS F3 PROGRAM 2 Select CONTROLS 3 Press TAB or ENTER to move to the list of controls 4 Selectthe next free entry 5 Press ENTER or double click to call up the screen for programming a new control The cursor is in the field Name 6 Type the name
28. maintenance The analyzer cooling unit and other devices parts and accessories are shipped in transport boxes and have to be unpacked and installed by a qualified service technician from the manufacturer or his designated representative If these instructions are not observed Vital Scientific N V does not assume responsibility for occurring damage or improper operation of the analyzer The customer is responsible for providing the necessary facilities as described in detail in chapter 2 7 Operation requirements and 2 9 Performance and technical data 1 4 4 External connections ATTENTION Warning Only instruments that meet the relevant safety requirements may be connected to the analyzer 1 4 2 Maintenance v ATTENTION Warning For continued protection against risk of fire only use fuses of the specified type and current ratings For maintenance and repair procedures e g replacement of cuvette rotor photometer lamp follow the instructions given by service personnel or specified in the manual Do not use unsuitable tools for repairs e g screwdrivers which are not insulated for work performed at electrical components During operation and maintenance of the instrument proceed according to the instructions and do not touch any parts of the instrument other than those specified Avoid touching all mechanisms i e sample needle while the instrument is operating This may cause operation to stop or damage the instrument Onl
29. ped Low Ref ped high Ref panic low Ref panic high Formula Text related to this Calculated result Keys F1 PRINT SHIFT F3 DELETE CLC RES F5 SELECT TEST F7 VALUE OR TEST VITALAB The low limit of the reference range for male samples If a measured value is below this limit the analyzer flags the result The high limit of the reference range for male samples If a measured value is above this limit the analyzer flags the result The low limit of the reference range for female samples If a measured value is below this limit the analyzer flags the result The high limit of the reference range for female samples If a measured value is above this limit the analyzer flags the result The low limit of the reference range for pediatric samples If a measured value is below this limit the analyzer flags the result The high limit of the reference range for pediatric samples If a measured value is above this limit the analyzer flags the result The low panic limit of the reference ranges for all samples If a measured value is below this limit the analyzer flags the results on the print out if the report set up is enabled The high panic limit of the reference ranges for all samples If a measured value is above this limit the analyzer flags the results on the print out if the report set up is enabled Here you can enter the formula for the calculated result at the cursor position Buttons F5 and F7 become active
30. retrieval of the old parameters values is not possible unless a back up of the test parameters has been made 5 4 1 TEST PROGRAMMING Parameters DUAL Req Aray buller0 0 Reagent Disc ROUTINE Programming 24444PM 19J N 2001 build Ma Start Test Programming 1 From the MAIN MENU select F5 SPECIAL FUNCTIONS F3 PROGRAM 2 Select TEST PROGRAMMING All programmed tests are displayed on the right hand side of the screen Additional tests may be entered in free positions A maximum of 55 tests can be programmed gt Test Programming Calibrators Controls Profiles DUAL MODE Profiles MONO MODE Calculated results Needle Incompatibility Cuvet Incompatibility Add a new test 3 Press TAB or ENTER to go to the test list 4 Move the cursor to a free field 5 Press ENTER or double click on the sem appropriate entry The first page of the PROGRAM TEST screen is shown 6 Enter the test parameters according to the respective method sheet here 7 Select F10 Return to return to Test Programming menu Repeat these steps to program additional tests Note m Enter the parameters exactly in the method sheets Modifv an existing test 1 Press TAB ENTER to go to the test list 2 Move the cursor to the corresponding field 3 Press ENTER or double click on that field The first page of the PROGRAM TEST screen TEST PARAMETERS is shown with the va
31. sample will show all the tests that belong to the selected profile e Select additional tests or deselect tests if necessary 6 Press F8 to store the current data Clear the screen for the next request 7 Repeat this procedure for each sample Note Define the profiles separately for both run modes Dual and Mono profile that you defined for the Mono mode is not available in the Dual mode Press Esc to close the window without selecting a profile You can also record a profile with the barcode reader Use profiles together with repeat mode 1 Press F3 PROFILE to open a window with a list of profiles 2 Select the desired profile 3 Press F4 Every new request that you created with F8 will now have the tests for that profile 4 Press F4 again to stop the repeat mode 4 1 6 Request a Stat sample with barcode reader To use the barcode reader certain preconditions must be met Refer to 1 1 3 Press F2 to change the sample status from Normal to Stat Or Select Stat at the parameter Sample Type The analyzer will process the Stat sample before all other samples Note Place all Stat samples to the assigned Stat positions Change a stored sample or request into emergency sample 1 Select the required sample 2 Press F5 PREV SAMPLE or F6 FORWARD SAMPLE to scroll through the list of stored samples and requests 3 Press F2 STAT to change the status of the sample to Stat Select a test on barcode reques
32. the measurement points are shown on the screen e Mono mode after 11 5 minutes e Dual mode after 4 5 and 11 5 minutes The measurement points marked with an arrow were used for calculation purposes by the analyzer The first column R shows the measured reagent absorbance for all methods only if the volume of the first reagent is larger than 220 ul The second column 1 11 shows the points measured before the VITAL SCIENTIFIC N V VITALAB Basic Routine EES second reagent was added The third column shows the results of the tests run with the second reagent for the individual measurement points below 12 21 or E 11 5 min The shown absorbances are already corrected to meet the respective value of the total volume of the tests in the cuvette Keys F1 PRINT Print the current screen F2 Switch between graphic and table mode Pressing F7 or ENTER to return F3 ACCEPT RESULT F4 REJECT RESULT F5 MEASURE AGAIN F6 MEASURE RERUN SHIFT F6 MEASURE ALL AGAIN SHIFT F2 TABLE CURVE F7 or ENTER F8 REQUEST SAMPLES F9 LOAD SAMPLES F10 MAIN MENU VITAL SCIENTIFIC N V to the normal mode Transfer the tests marked with INFO to the results printout for a manual validation of test results WAITING FOR YOUR DECISION is shown on the right hand side on the screen The result will only be transferred if this is enabled by the error that has caused the mark INFO i e F3 is not available for serious errors such as INSUFFI
33. to 10 formulas can be set The results are Cone not used for quality control Prt DAL MODE Profiles MODE gt Calculated results Needle Incompatibility Cuvet Incompatibility 5 9 1 Program Calculated Results 1 Select from the MAIN MENU F5 SPECIAL FUNCTIONS F3 PROGRAM 2 Select CALCULATED RESULTS menu and press ENTER 3 Select a previous entered name or an open position and press ENTER 4 Type the following parameter fields Toms EMI EES 5 Create a new formula by entering a value f in each field or bv selecting a test in each field Combinations are possible Emm Emm Emm Emm Emm Name Name of the calculated result If no name is entered here the calculated result will not be stored Abbr Name The abbreviated name of the calculated result If you create a new name you have to specify an abbreviated name here Otherwise the calculated result will not be stored Units The unit for the calculated result By pressing ENTER a drop down menu shows the available units Decimals The number of places after the decimal point Note The screen contents changes depending on the type of units and number of decimals chosen Enter the reference range values Notice that the low limit values have to be lower than the high limit values VITAL SCIENTIFIC N V 5 27 Extended Routine Ref male low Ref male high Ref female low Ref female high Ref
34. wash arm and clean with the cleaning rod the aspiration needles long needles Also see 1 Service personnel only Check the vacuum and valve 2 and 4 3 The message looks erroneous There is no clear overflow There is a cause for conductance between the overflow sensors on the wash arm and the plate of the wash arm 3 Lift the wash arm and clean the underside of the wash arm especially around the overflow sensors Service personnel only Check the overflow signal replace wash arm if necessary E125 NO CUVETTES There is no cuvette rotor installed At resetting the wash arm can reach a too low position according to the opto read out Check if a cuvette rotor is present and place one if necessary Then press F5 SPECIFIC RESET Service personnel only Check if the wash arm adjustment is correct Check if the opto couplers are malfunctioning and repair them if necessary Check if the wash arm is well tightened E135 WASHARM RESET FAILED Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET See also E122 washarm error E136 BELLOWS PUMP RESET FAILED Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET E137 WASHARM BELLOWS PUMP COMM ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET VITAL SCIENTIFIC N V VITALAB Special functions 64 Maintenance procedures The analyzer has very low maintenance require
35. when editing the formula You can set a value in each of the formula fields or you can choose a pre set test You can create a text to the calculated result This will be printed on the results list only when the calculated results can be derived Prints the definition of the calculated test Deletes the definition of the calculated test When the cursor is focused on a field in the formula that is selected as a test pressing F5 opens a drop down menu allowing you to choose between the available tests Toggles between value or test in a field in the formula Note Printing of all calculated results is only performed if all data needed for the calculation is available if the calculated test is programmed in the user defined report set up and if the Use report lay out checkbox is checked in SPECIAL FUNCTIONS INSTALLATION COMMUNICATION menu a result cannot be calculated then the text related to this calculated result will not be printed 5 28 VITAL SCIENTIFIC N V VITALAB Extended Routine em SA Example for printouts PATIENT NAME SMITH MARY ORDERING PHYSICIAN JONES M D TEST RESULTS FLAGS UNITS REFERENCE RANGE UREA 6 Low MG DL 7 18 CHOLESTEROL 167 MG DL lt 200 TRIGLYCERIDES 154 MG DL 36 165 52 MG DL 30 75 VLDL 3 1 MG DL 10 38 LDL 84 MG DL 66 178 HDL 31 HIGH 20 30 CHOL HDL RATIO 3 2 RATIO 2 7 6 7 MEN WOMEN 1 2 AVERAGE RISK 3 4 3 3 AVERAGE RISK 5 0 4 4 2X AVERAGE R
36. 0 tests per hour 270 with optional ISE unit DUAL MODE 133 test per hour 222 with optional ISE unit Refer to note 1 Refer to note 1 55 per programmed reagent disc 3 per parameter 15 controls programmable per reagent disc Entirely selective sample oriented 1 to 30 ul per test 51 patient samples 3 positions 9 positions plus max 51 patient sample positions 5 positions 1 4 4 positions plus max 51 patient sample positions 4 Primary secondary tubes Diameter 13 16 mm Height max 73 mm With level detector and integrated mixer 1 30 ul steps of 0 1 ul 100 ul 6 pediatric sample rotor 32 positions 24 x 25 ml 8 x 8 ml and 5 x 50 ml bottles possible Reagent 1 110 399 ul reagent 2 0 10 180 ul Up to 12 C below ambient temperature Pre heated with level detector and integrated mixer 400 ul steps of 1 ul 1000 ul 8 for 8 ml bottle in 25 ml position VITAL SCIENTIFIC N V VITALAB Introduction Measurement Station Cuvette rotor Multi use disposable rotor with 48 positions Path length 6 8 mm Minimum volume 220 ul Wash station fully automatic with overflow level detector Cuvette rinsing 4 x 500 ul svstem liquid Light source Halogen lamp 12V 20W Wavelength 340 376 405 436 505 546 578 and 620 nm Wavelength uncertaintv 2 nm Spectral half width value 10 2 nm Measuring range 0 1 to 3 0 Abs Temperature 37 0 2 Cycle time 20 sec MONO MODE 27 sec DUAL MODE
37. 01 16 21 The easiest and fastest way to inform the technical service about the detected malfunctions is to send the printout to the respective service technician per fax 1 Select MAIN MENU F4 SERVICE ERROR HISTORY 2 Press TAB or ENTER Each error message displayed by the analyzer is documented here Operator command RESET SYSTEM FI F2 F4 F5 Fe F8 amp wm w Print Print Service Special Quality Eval Request Load Main Funct Control _ Samples _ Samples _ Samples Menu On the left side of the display date and time of an error is displayed The right hand side shows the corresponding error number and an error description The analyzer also documents which measures the user took i e which keys were used Use the cursor keys to scroll through the list of messages 3 Select F2 PRINT ALL to print out the entire error history Keys F1 PRINT Print out the selected error message including date and time of occurrence F2 PRINT ALL Print out the complete list of error messages including last needle rinsing and last system cleaning data Make sure there is enough paper in the printer F4 SPECIAL Switch to the SERVICE menu FUNCTIONS F5 SPECIAL Switch to the SPECIAL FUNCTIONS menu Evaantinaic VITAL SCIENTIFIC N V 6 5 Special functions VITALAB jA FUNCTIONS F6 QUALITY Switch to the QUALITY CONTROL menu CONTROL F7 EVAL Switch to the EVALUATE
38. 1 on the PC 3 Connect the other end of the serial cable with the RS232 connector on the rear side of the Analyzer 7 2 VITAL SCIENTIFIC N V VITALAB Installation 7 2 Software installation 7 2 1 General Install the software only by someone who is familiar with Windows Note Vital Scientific N V does not guarantee that the program functions properly when third party programs are installed and or active on the PC Do not run other programs during the use of the Analyzer program Requirements e as specified in section 2 9 of the manual e Analyzer installation disk 1 2 and 3 or CD rom 7 2 2 Prepare PC Screen area To run the Analyzer program set the screen area on 800 x 600 pixels 1 Run WINDOWS EXPLORER Display Properties 2 x 2 Select MY COMPUTER CONTROL PANEL Background Screen Saver Appearance Effects Web Settings DISPLAY 3 Select Settings tab Select in the Screen area field 800 x 600 5 Press OK Display DELL 990 on 3D Rage Pro atir3 Colors Screen area 3 True Color 24 bit Less More mu I 800 by 600 pixels JZ Extendiny windows desktop onta this monitor Advanced VITAL SCIENTIFIC N V 7 3 Installation Screen saver The screen saver must be disabled to guarantee the most stable performance 1 Run WINDOWS EXPLORER 2 Select MY COMPUTER CONTROL PANEL DISPLAY 3 Select Screen Saver tab S
39. 8 REQUEST SAMPLES F9 LOAD SANPLES F10 MAIN MENU Results screen for kinetic test The graphic mode shows results of a kinetic test run in the Dual Mode The analyzer shows 21 different points marked on the x axis To calculate the delta absorbance the analyzer has used the last eight points 14 to 21 These points were measured after the second reagent was added The first 13 points were only measured but not used for calculation purposes The arrow shown at the last point measured before reagent 2 was added shows the distance between this measurement point and the absorbance level of the substrate depletion defined in the TEST PROGRAMMING menu which is identified by the dotted line Since none of the measurement points lies on or below this level the substrate was never depleted during measurement As all measurement points lie inside the defined absorbance limits also specified in the TEST PROGRAMMING menu no error message is shown 4 20 Go to the MAIN MENU VITALAB Blank Factor Special Functions 000 0234 Ab 248411 Rotor System ISE installati stallation 1 0000 dAbs m 21430 113 14878 1 0000 0204 d bs 292824 Print a list of all shown results for blank measurements calibrations Go to the QUALITV CONTROL menu Go to the EVALUATE SAMPLES menu Go to the REQUEST SAMPLES menu Go to the LOAD SAMPLES menu DUAL Req ray buffe
40. A DIGO 2Digoxn ng ml You can check the test results of a sample i e view the points in the graphic or compare the individual values of the absorbances For this check select the required sample with the arrow keys Use PAGE UP PAGE DowN keys if V pim required You can also enter the sample number in Eran the entry field above the sample list to select the FI F3 Shit F4 F7 F9 F10 sample or use the barcode reader s The left screen shows sample data the position Rum ns doen dud sede Mes of the sample on the sample rotor and the status Press 7 to go to the graphic mode You can select one of the processed tests on the left with the cursor keys A graphic of the corresponding test processing is shown When INFO is shown next to the test you must validate the results This only applies if Automatic Evaluation in the SYSTEM PARAMETERS menu was nol selected The sample will not be released and the analyzer does not print it Sample information number name etc test name and unit are shown above the table or the graphic A message indicates why the test was not released Due to this message e g Reagent Absorbance Limit Error you are required to make a decision Waiting For Your Decision The graphic shows the result of a two point test run in the Dual Mode Measurement points which are used for t
41. AILED Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET Inform the service technician if the error occurs again E57 MEAS DISC COMMUNICATION ERROR Inform the service technician E60 SAMPLE ARM 14V FAILED E61 SAMPLE ARM 30V FAILED Inform the service technician E62 SAMPLE ARM HORIZONTAL ERROR E63 SAMPLE ARM VERTICAL ERROR E75 SAMPLE ARM RESET FAILED E76 SAMPLE ARM RESET FAILED E77 SAMPLE ARM COMMUNICATION ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET E80 REAGENT ARM 14V FAILED E81 REAGENT ARM 30V FAILED Inform the service technician E82 REAGENT ARM HORIZONTAL ERROR E83 REAGENT ARM VERTICAL ERROR E95 REAGENT ARM RESET FAILED E96 REAGENT ARM RESET FAILED E97 REAGENT ARM COMMUNICATION ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET E100 DISCS 14V FAILED E101 Discs 30V FAILED Inform the service technician VITAL SCIENTIFIC N V VITALAB Special functions Error message Cause Action E102 REAGENT DISC ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET E103 SAMPLE DISC ERROR Press either F5 Specific Reset or select SHIFT F6 SYSTEM RESET E115 REAGENT DISC RESET FAILED Press either F5 Specific Reset or select SHIFT F6 SYSTEM RESET E116 SAMPLE DISC FAILED Press either F5
42. Approx 85 kg Power requirements Line Voltage 110 240 V nominal tolerance 10 Line Frequency 50 60 Hz Power Consumption 320VA Installation categorv Il in accordance with IEC664 Environmental requirements Ambient temperature 15 to 32 Max relative humiditv 85 RH max Pollution degree 2 in accordance with IEC 664 2 14 VITAL SCIENTIFIC N V VITALAB Svstem Handling Basics Svstem Handling Basics VITAL SCIENTIFIC N V 3 1 System Handling Basics VITALAB 3 1 Work Preparation Read this chapter carefully before you start working with the analyzer Always observe the safety instructions in order to prevent accidents Note In this manual the dilution ratios are given as parts of the sample to parts of the resultant solution Thus a dilution ratio of 1 5 means 1 part of the sample diluted with 4 parts of diluent that results in 5 parts of solution 3 1 1 Manual Use Each chapter that describes the operation of the analyzer contains a function section followed by an example The function section contains information about key and field functions available in the menu structure The example gives clear explanations and instructions Example for a function section Recording of Sample Requests SAMPLE NUMBER 12 characters letters and numbers are available for the sample number To increase the sample number by one for the next request you can select the automatic increase checkbox in the S
43. CIENT SAMPLE Reject the currently shown result The rejected result is marked REJECT Repeat the test The volumes that are used for the repeated measurement are identical with those that were originally used The function is only available if the sample is stil on the sample rotor i e F4 was not pressed in the LOAD SAMPLES menu Automatically repeat the test Unlike F5 the defined volumes that are used here for the repeated test are the volumes that were defined in the field Rerun Vol of the test parameters The function is only available if the sample is still on the sample rotor i e FA was not pressed in the LOAD SAMPLES menu If a calibrator has been run in duplicate or in triplicate the option Measure All Again appears If selected the instrument will measure this single standard again in duplicate or triplicate Do not use this function if a calibration fails but repeat the request of the entire calibration If the test is a calibration the calibration curve together with concentrations measurement values and limit values are shown after pressing SHIFT F2 Return to the normal mode Go to the REQUEST SAMPLES menu Go to the LOAD SAMPLES menu Go to the MAIN MENU 4 19 Basic Routine Info screen for blank calibration All programmed tests together with last blank measurement last calibration result and the factor from TEST PROGRAMMING are shown Keys F1 PRINT F6 QUALITY CONTROL F7 EVALUATE SANPLES F
44. ER in the field Target 2 Select either Negative or Positive from the drop down list 3 Confirm your selection and return to the ee previous menu with F10 RETURN 4 Set remaining controls if necessary Correlat factor The correlation factor is a calculation factor used internally by the system The analyzer multiplies the result of the measurement with the value entered in this field The setting 1 000 is the default value for all methods with a quantitative evaluation No correlation factor is available if a qualitative evaluation cut off was selected for the corresponding test Correlat offset The value entered in this field is a calculation value used by the system The analyzer adds the correlation offset as a constant value to the result of the multiplication of measured result and correlation factor measuring result x correlation factor correlation offset final result VITAL SCIENTIFIC N V 5 13 Extended Routine VITALAB The default setting for all methods is 0 000 The correlation offset is not available for cut off tests Note a The difference Bias between individual methods on different analvzers can be balanced out bv means of the correlation factor and correlation offset Screen Page 2 DUAL MODE and Screen Page 3 MONO MODE The functions of the individual fields for Dual Mode and Mono are identical the fields for the second reagent and the field Substrate depletion ar
45. FT F6 SYSTEM RESET Inform the service technician if the error occurs again E23 REAG SYR POS ERROR E24 REAG SYR POS ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET Inform the service technician if the error occurs again E25 REAG VALVE ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET Inform the service technician if the error occurs again E30 PIPETTOR 14V FAILED E31 PIPETTOR 30V FAILED Inform the service technician E35 SAMPLE SYR RESET FAILED E36 REAGENT SYR RESET FAILED Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET Inform the service technician if the error occurs again E37 PIPETTOR COMMUNICATION ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET Inform the service technician if the error occurs again VITAL SCIENTIFIC N V Special functions SSS VITALAB Error message Cause Action E40 MEAS DISC 14V FAILED E41 MEAS DISC 30V FAILED Inform the service technician E42 MEASUREMENT DISC ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET E43 FILTER ERROR Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET Inform the service technician if the error occurs again E55 MEAS DISC RESET FAILED Press either F5 SPECIFIC RESET or select SHIFT F6 SYSTEM RESET E56 FILTER RESET F
46. ILL EMPTV SYSTEM Follow the instructions displayed on the screen 2 Press F1 FILL SYSTEM to start filling the analyzer with system liquid 3 When the filling is complete make sure that the tubing e g tubing of sample probe or reagent probe is filled with system liquid without air bubbles 4 If you detect any air bubbles press F1 to repeat the procedure a System Remove the system liquid hose from the water container 2 Select F5 SPECIAL FUNCTION F1 ROTOR SYSTEM FILL EMPTV SYSTEM Follow the instructions displayed on the screen 3 Press F2 EMPTY SYSTEM to empty the analyzer for transport Make sure that there is no system liquid left in the tubing 5 If necessary press F2 to restart the emptying The remaining waste must be removed after the procedure has been completed 3 2 7 Operation Prerequisites Observe the following prerequisites before going into operation Warning a Always observe the common safety precautions rubber gloves splash protection Caution a Check the cooling unit for the correct voltage before you connect the cooling unit Never let the cooling unit pump run dry because this will damage the pump Power supply Connect the system cables correctly Switch on the analyzer The monitor system stand by mode must show the Standby mode as needed Cooling unit Fill the cooling unit correctly with coolant Install the tubing of the analyzer unit correctly Switch on the cooling unit
47. ISE unit is used It is easy to adapt the analyzer in any kind of laboratory In the main unit of the system the actual analyzer all liquid handling and measurements take place A separate computer controls the analyzer unit collects the raw data and provides the user interface A cooling unit enables the system to ensure the precision of all on board parameters Environmental compatibility and economic efficiency are guaranteed Easy operation menu and message control by display short training time as well as recording of sample and test data with barcode scanner reduce personnel assignment and save a maximum of time VITAL SCIENTIFIC N V 2 3 Introduction VITALAB w CCC 23 Analyzer Note In the screen texts system liquid is replaced water The Vitalab analyzer is a PC controlled clinical chemistry analvzer It is designed as a random access full selective patient oriented system The test parameters for 55 different tests can be programmed The analyzer can run simultaneously from 1 up to 26 tests The analyzer has the following measurement capabilities In the dual mode e Reagent absorbance bichromatic before sample addition e Kinetic 1 during 4 5 minutes after sample addition can be used as slope blank for kinetic 2 e Kinetic 2 during 4 minutes after reagent 2 addition e Kinetic 1 2 during 8 5 minutes after sample addition e Sample blank bichromatic before reagent 2 addition e End poi
48. ISK 9 6 7 1 3X AVERAGE RISK 15 0 11 0 SODIUM 143 MEQ L 136 145 POTASSIUM 2 0 PANIC MEQ L 3 5 5 1 NAME OF YOUR LABORATORY VITAL SCIENTIFIC N V 5 29 Extended Routine VITALAB 5 10 Error Flags and Messages Th H H Stand by DUAL Req Atay 0 0 Reagent Disc ROUTINE Enor history 20914PM 22JAN 2001 build 0 3 3 51 analyzer constantly checks its settings even ET WASTE FULL during sample processing test programming or in 22 the stand by mode Each deviation from the set 2mm reference values is immediately displayed on the screen in form of messages error message informs the user about operating errors and system errors and faults with the corresponding action to take For example insufficient liquids in the system and errors in the system setting The most important error messages are described in chapter 6 Operator command CHECK AGAIN In this chapter the error flags causes and actions E 7 to take are described Some of the functions related Q mh uw Print Print Service Special Quality Eval Request Load Main to error flags and the actions required are described Serpex sano Mon too Some messages accompanied acoustic signals Pressing key e g space stops the signal There are several ways for the user to react ifa message is displa
49. In case of the reagent syringe the air bubble can be removed by ticking with your finger against the syringe In case of the sample syringe the procedure must be repeated 8 Mount the plunger over the drive pin of the pipettor hold the syringe vertically and pull it straight up 9 Screw the syringe in the pipettor valve Make sure the syringe can be screwed in easily Tighten well with your hands 10 Select F2 RESET PIPETT in order to reset the pipettor and F10 RETURN to leave the menu If the analyzer is now in the Halted state reset the complete analyzer 6 20 VITAL SCIENTIFIC N V VITALAB Special functions 11 Selectthe FILL EMPTY SYSTEM menu from the MAIN MENU press F5 SPECIAL FUNCT F1 RoTOR SYSTEM and press F1 REFILL SYSTEM After refilling the system the instrument is ready for use again If there are still air bubbles visible in the tubing repeat the refilling procedure 6 4 6 washing filling cuvette rotor Wash and fill the cuvette rotor as follows 1 Stop any processing of samples 2 Check the water supply and fill up the 10 container if required 3 Select MAIN MENU F5 SPECIAL FUNCT F1 ROTOR SYSTEM ROTOR NEEDLE RINSE 4 Press TAB or ENTER 5 Select F2 WsH FIL As soon as washing filling of the cuvette rotor is finished the system switches to the stand by mode The analyzer also offers the possibility of washing the rotor only by selecting F1 WASH After finishing the routine all
50. LAB Extended Routine TO Kevs TAB Move between the controls list and tests list ENTER The same as If an invalid control test combination is selected the message combination will be displaved CURSOR KEVS Move within a list of controls or tests 5 1 2 Graphic Representation of Quality Control The analyzer displays a graphic representation of valid control test combination measurements A maximum of 30 results per control and test are stored If more than 30 tests are run the earliest results are deleted FIFO Select From the MAIN MENU F6 QUALITY CONTROL menu Select CONTROL NAME Press TAB Select Test Select F6 GRAPHIC MODE Select F2 TABLE MODE to view the table Select F2 GRAPHIC MODE to view the graph oe Qi A ON Parameters visible in Graphic Mode LHS The parameters shown to the left of the graph are as follows Control Name Displays the name of the control Batch Displays the reagent manufacturers batch number Number Test Name Displays the name of the test assigned to this control Target The reference value set in PROGRAM CONTROL Low Limit The low limit as set in PROGRAM CONTROL High Limit The high limit as set in PROGRAM CONTROL Westgard Displavs the status of Westgard option AV Displavs the mean value of all measured values SD Displavs the standard deviation of the measured values CV Displays the coefficient of variation of the measured values as N Displays the num
51. M and other handheld mobile equipment may affect proper operation of the equipment Note This is class product This product may cause interference in domestic environment this case the user may be required to take adequate arrangements 2 10 VITAL SCIENTIFIC N V VITALAB Introduction 28 Move the analyzer Please follow the instructions below when the instrument needs to be moved over a larger distance 1 Switch off the analyzer the computer and the cooling unit 2 Disconnect all cables and tubes 3 Remove the door of the syringe compartment by lifting it when fully opened 4 Pull up the arms and place the arm protection tubes over the shafts The arms are prevented from going down 5 Move the analyzer with at least 2 persons Hold the instrument only by the metal frame on the bottom 6 Connect all cables and tubes again when the analyzer is in place VITAL SCIENTIFIC N V 2 11 Introduction VITALAB 2 9 Performance and technical data Performance Throughput Accuracy Precision Programmable tests Loadable tests Quality control Sample processing Sample volume Sample system Sample positions Emergency samples Calibrators Pediatric samples ISE position Blank position Controls Rinsing position Sample tubes Sample needle Pipetting capacity Syringe Adapter Reagent system Reagent rotor Volume test Cooling Needle Pipetting capacity Syringe Adapter 2 12 MONO MODE 18
52. OUTINE eedeincompal 1 3 amp 39 22JAN 2001 Display the test list and Select a test Select a test or row Scroll through the test list page by page Print out the displayed screen Delete the selected parameter Link the selected tests The second test is processed directly after the first Make the test incompatible The second test is not processed directly after the first Return to the NEEDLE or CUVET INCOMPATIBILITY display VITAL SCIENTIFIC N V VITALAB Extended Routine rese O NI Note A test with a superscripted D refers to the sample blank or dummy test whereas a test without a D refers to the normal test 5 6 3 Define Incompatibilities The following refers to the NEEDLE INCOMPATIBILITY menu To define cuvette incompatibilities use the same procedure The analyzer can hold up to seven incompatible and compatible tests for each test In this example the test B must never be processed after test A 1 Select from the MAIN MENU F5 SPECIAL ie ee es FUNCT F3 PROGRAM i 2 Select Needle Incompatibility 3 Press ENTER to activate the Needle incompatibilitv overview Information on test definition is found in the method sheets for the reagents 4 Place the cursor in the first column behind the test A 5 Press ENTER to show list of tests 6 Selectthe test B that must never go after test A d e 7 P
53. READY Graphic Table Mode sma Sma gt 00376 0139 gt 0144 00045 00231 00232 4 21 Basic Routine VITALAB Results screen for a two point test with blank slope The graphic mode shows the result of a two point test with slope blank The measurement was done in the Dual Mode The analyzer shows 21 points that are marked on the x axis For the calculation of the slope blank the analyzer has used the measurement points 7 to 11 indicated by the circles The points 1 to 6 were not used for the calculation This selection depends on the incubation time here 77 seconds defined for the blank slope in the TEST PROGRAMMING menu The points 13 and 18 were used for calculating a delta absorbance for the test result The remaining points were measured but not used for the calculation In this example the delta absorbance of the reaction between the points 13 and 18 has been corrected by the blank slope determined between the points 7 to 11 If you switch to the table mode with F2 the screen shows the absorbances in a table At the top of the table the calculation results are shown by two delta absorbance values The first value is the delta absorbance of the blank slope The second value is the delta absorbance of the two point test not yet corrected by the blank slope The column R states the measured reagent absorbance The column 1 11 shows the points measured for the slo
54. SAMPLES menu SAMPLES F8 REQUEST Switch to the REQUEST SAMPLES menu SAMPLES F9 LOAD Switch to the LOAD SAMPLES menu SAMPLES F10 MENU Return to the MAIN menu 6 3 5 Error code lis The error messages displayed by the analyzer can be divided into two groups flag error messages and hardware error messages Error Messages Flags Refer to chapter 5 3 Flag error messages are printed behind a test result Error messages that are marked with an asterisk in the list below are also displayed on screen and can be recognized by an acoustic signal which can be stopped by pressing the space bar Error messages that are not marked will be printed out INSUFFICIENT REAGENT NO REAGENT TAKEN REAGENT PIPETTING STOPPED LAMP UNDERRANGE LAMP OVERRANGE LAMP UNDERRANGE REF CHANNEL LAMP OVERRANGE REF CHANNEL INSUFFICIENT SAMPLE LINEARITY ERROR ABSORBANCE LIMIT ERROR REAGENT ABSORBANCE DEVIATION ERROR REAGENT BLANK LIMIT ERROR CALIBRATION LIMIT ERROR CONTROL LIMIT ERROR REFERENCE LIMIT ERROR REAGENT ABSORBANCE ERROR xa 6 6 VITAL SCIENTIFIC N V VITALAB Special functions Error message Cause Action INSUFFICIENT REAGENT Safetv switch of the reagent needle is activated bottle empty Liquid detection of the reagent needle is not detecting any liquid bottle missing or empty Liquid detection is not working NO REAGENT TAKEN Filling level of the reagent bottle is too high
55. Specific Reset or select SHIFT F6 SYSTEM RESET E117 REAG SAMP DISCS COMMUN ERROR Press either F5 Specific Reset or select SHIFT F6 SYSTEM RESET E120 WASHARM BELLOWS PUMP 14V FAILED E121 WASHARM BELLOWS PUMP 30V FAILED Inform the service technician E122 WASHARM ERROR Press either F5 Specific Reset or select SHIFT F6 SYSTEM RESET Make sure the cuvette rotor is placed correctly E123 BELLOWS PUMP ERROR Press either F5 Specific Reset or select SHIFT F6 SYSTEM RESET Note that this error often occurs with other errors First try to solve the other errors This error might also disappear then E124 WATER OVERFLOW MEASUREMENT DISC The wash arm detects that liquid reaches its overflow sensors In the halted or inactive state remove the cuvette cover and then continue running Determine which of the causes 1 2 or 3 is the case and take the respective action 1 The wash arm dispenses too much water Probably all cuvettes under the wash arm show a water overflow 1 Check that the tubing between pump unit and main unit and the tubing between pump unit and the bottles is not bent or clogged VITAL SCIENTIFIC N V 6 13 O O Special functions VITALAB mi Error message Cause Action 2 Some or all needles of 2 In the CHANGE ROTOR the wash arms do not aspirate correctly Probably only a few cuvettes show water overflow menu lift the
56. V Attention Be sure to switch off the instrument before replacing the lamp Make sure that no samples are currently being processed 1 Switch off the analyzer and remove the front cover safety screw in the middle of the device the screw can only be seen from below 2 Open the front of the analyzer by simply pulling at the sides of the cover Warning The lamp may be hot 3 Loosen the top screw of a total of three Screws with a screwdriver and remove it 4 Carefully pull the support out towards you Attention Cable connections mi 5 Remove and dispose of the lamp 6 Carefully take the new lamp part of the range of supplv bv its top using a clean cloth The new lamp must carefully be placed into the support and fastened 7 Reinstall the support and fasten the screw The lamp must be adjusted with the two screws below the top screw w Attention Do not touch the glass part of the lamp with your fingers Fat dust and humidity shorten the life of a lamp and limit its function Be careful for movable parts when the instrument is switched on again 8 Adjust the lamp 1 Select F5 SPECIAL FUNCTIONS FUNCTIONAL CHECK ADJUSTMENTS ADJUST LAMP 2 Press TAB or ENTER A screen is displayed showing two bars representing the lamp intensity that is measured by the reference detector Lamp and the actual detector Cuvette 6 18 VITAL SCIENTIFIC N V VITALAB Special functions 3 Adjust the lamp scr
57. XPLORER 3 Select MY COMPUTER CONTROL PANEL ADD REMOVE PROGRAMS 4 Press Install 5 Insert the Analyzer installation disk 1 into the floppy drive A 6 Press Next 7 Press in the Run Installation Program screen Finish Installation 1 Press in the Welcome screen Next 2 Press in the Select Program Folder screen Next 3 Press in the Start Copying Files screen Next 4 Change the installation disks in the floppy drive A when requested 5 Press in the Setup Complete screen Finish VITAL SCIENTIFIC N V Run Installation Program ristell Strela Installation 7 5 Installation VITALAB 7 2 4 Files The installation creates following directories e C Program Files Analyser The directory EN Exploring Analyser olx contains the files as shown in the figure File Edt View Go Favorites Tools Help gt m 2 Back Cut Copy Paste Address a C Program Files Analyser 21 Spanish alf ie analyser dll AnalComexe 9 Cw3215 dll ta AnalHost exe B Analhist dat amp amp analprog exe B Blnkqain dat d analprt exe B Cuvhist dat pee isr Analyser exe B Ermhist dat elsL1 isu s isreg32 dl 3 lseCalb dat e C Program Files Analyser Standard ON LELI The directorv contains the files as shown 8 Sctory ee aax the figure Bak 1 Up Copy U
58. YSTEM PARAMETERS menu F2 STAT The request displayed on the monitor is marked as an emergency sample Stat When an example follows the function section the example describes the method of the procedure In this case the necessary steps to record a patient s sample and to request a sample test are explained and illustrated Stand by DUAL Req Aray buffer0 0 Reagent Disc ROUTINE Request Samples 10 35 28 AM T8JAN 2001 buid 09 9161 Main Menu Special Functions Rotor System ISE Installation Programming Service Quality Control Sample Number D CK Na GOT Sample Name Calcium Total bilirubin Evaluate Samples Phosphatas gt Date of birth I Creatinine cholesterol DualBichromaat 2Digoxin CReaclive pro CheckR F8 F10 Load Main Menu Example Before you start manual recording always enter the sample number at the parameter Sample Number otherwise no analysis can be made Enter further patient data or move directly to test the Request Samples by pressing the TAB key or by using the mouse 3 2 VITAL SCIENTIFIC N V VITALAB 3 1 2 Menu structure Svstem Handli ng Basics cm The analyzer software is menu driven All the functions are accessed from the MAIN MENU The following diagram shows the main functions MAIN MENU F5 Special Function F6 Quality Control F7 Eva
59. a 104000 04300 normally increasing curve the result is POSITIVE 2 lfitislower itis NEGATIVE and vice versa in case of a decreasing curve 2 Select flag and press ENTER select Yes or No from the drop down list Press ENTER to S m confirm If Yes is selected and the result is AL within value of the cut off deviation grev area the analyzer prints an extra flag in the results report 3 If cut off and flag has been selected in the PROGRAM CALIBRATOR screen then extra parameters will appear on pages 2 and 3 of the TEST PROGRAMMING screen The following parameters appear on pages 2 and 3 of the TEST PROGRAMMING Screen Cut off value The result of the calibration The analyzer displays the value of the cut off calibration The user can enter a value but it is not recommended Cut off dev Enter the Cut off deviation that causes a flag Example The result of a cut off calibration was calculated to 0 120 delta abs m The cut off was programmed as Yes decrease flag Yes cut off deviation 0 010 delta abs m The result of the sample is 0 112 delta abs m POSITIVE since 0 112 is lower than 0 120 and flagged with an E as the deviation is 0 008 delta abs m and is in the range of 0 120 0 010 delta abs m 5 20 VITAL SCIENTIFIC N V VITALAB 5 5 3 Calibration Curves If three or more standards maximum 9 are used for calibration the instrument produces a calibration curve at the end of th
60. agent The available reagent volumes The number of tests which can still be processed with the available reagent The number of tests that is currently requested Refill the reagent Print a list with the reagent information Confirm that you have refilled the reagents In Counter mode Delete the statistics and reset all counters to 0 Switch between Counter mode and Normal mode Go to the EVALUETE SAMPLES menu to check all results and do validations if necessary Go to the REQUEST SAMPLES menu Go to the LOAD SAMPLES menu Go to the MAIN MENU VITAL SCIENTIFIC N V VITALAB Basic Routine Check and refill reagents 1 Press F5 to go to the REAGENT INFO menu 2 Refill the reagents that are marked with an asterisk in the Fill column 3 Press F2 CONFIRM REFILL The analyzer will assume that all the reagents have been refilled The screen is updated Note m Check the loaded reagents and their volumes before you start the analysis run If you have already selected the REAGENT INFO menu F5 before the start of the analyzer run you can only go back to the LOAD SANPLES menu F9 Insufficient reagent The analyzer gives a warning if the reagent volume becomes insufficient for a test during sample processing The test results however are not distorted or lost in any way The analyzer gives a message that you must refill the reagent and confirm this with F2 CONFIRM REFILL The analyzer then repeats the test
61. asured Therefore make sure that the required test is positioned when setting up a report 5 Select F10 STORE amp RETURN to save the new layout and return to the previous menu The analyzer will now layout the printouts Keys F1 PRINT Print out the report layout This is only possible if a result printer is activated in the LAYOUT COMMUNICATION menu F3 PLACE After pressing F3 select an element from the drop down list and press ENTER to ELEMENT place it at the cursor s current position Position the cursor on the desired place first to position an element F5 SELECT TEST Select test from the drop down list and confirm with ENTER Test specific elements placed with F3 refer to this test SHIFT F7 CLEAR Clear the layout completely without confirmation LAYOUT FIOSTOREAND Save the current layout and return to the previous screen RETURN CURSOR KEYS Position the cursor on the screen VITAL SCIENTIFIC N V 6 3 Special functions VITALAB 6 3 Troubleshooting The analyzer reflects the most up to date technological standards and was designed to be as user friendly as possible It constantly monitors all functions and informs the user about operating errors and system malfunctions However in technical systems operating errors and certain system malfunctions can never be fully excluded especially since mechanical components are always subject to wear The most frequent malfunctions caused by wear are described in the following
62. asurement 6 17 6 4 4 Replacing the Photometer 6 18 6 4 5 Replacing syringes and syringe tiIpS nn 6 20 6 4 6 washing filling cuvette rotor a nennen nnn 6 21 6 4 7 Needle menn nennen nennen nnn nennen nsns 6 21 7 7 1 7 1 Hardware 7 2 7 2 Software installation 7 3 21 E 7 3 Z 2 diode ui 7 3 7 2 3 Install software 7 5 Th Be T n m 7 6 1 93 Configure SON 7 7 7 3 1 Configure Analyzer Printer 7 7 7 3 2 Configure Analyzer Communication 7 7 7 3 3 Configure Host Communication 7 8 7 4 Backup procedure een eene nnnn nen n nennen 7 9 8 1 8 1 Interface Description 8 2 8 1 1 RS 232 Description u 8 2 VITAL SCIENTIFIC N V VITALAB Safetv Precautions and Potential Hazards S Safety Precautions and Potential Hazards VITAL SCIENTIFIC N V 1 1 Safety Precautions and Po
63. atch Number and Sample Type and a list of available controls are shown These controls have been defined in the CONTROLS menu 3 Select the required control The parameter Control Name shows the name of the control The Batch Number shows the lot number On the right a list is shown with all tests which can be tested with this control These tests have been defined in the CONTROLS menu 4 Select the required test 5 Press F8 to clear the screen for a new control or sample request VITAL SCIENTIFIC N V 4 7 Basic Routine VITALAB Request a test for calibration 1 2 3 4 During the selection of the tests no name is shown at Calibrator Name The analyzer cannot assign the calibrators until the request is completed Press F5 to check which of the standards has been allocated to the individual tests Select the parameter Sample Type Select Calibrator from the drop down list Calibrate Name A list of available tests is shown These tests T E require calibration according to their method Creatinine sheet cholesterol Glucose Select the required tests Uem 2 Digoxin Press 8 to store the selection Clear the C Reactive pro screen for the next request Sample Calibrate Press F6 to view the completed requests The monitor shows Calibrate in the field Sample Type The name of the calibrator for this test is shown at Calibrator field The calibrator is
64. ber of control measurements VITAL SCIENTIFIC N V 5 3 Extended Routine VITALAB www mum Graphic Displays RHS DUAL Req Aray buffer 0 5 Reagent Disc ROUTINE Qual Contr Graphic 10 28 15 AM 19JAN 2001 Graphic Mode able 10 Points the graph Each point represents one control measurement with the corresponding test The quality of the test can be monitored from the spread of the points The display of the points depends on the mode DUAL MONO MODE that the control was run and whether the measurements meet the evaluation rules Westgard rules measurement DUAL MODE o measurement MopE X does not meet the Westgard rules H The line H indicates the set HIGH limit L The line L indicates the set LOW limit Arrow An arrow pointing up or down indicates that a result is outside the range of the graphic display The result must be checked in TABLE MopE and marked Reject if necessary R An R at the top or lower edge of the display indicates that the operator in TABLE MopE has rejected the result Table Mode The columns display the results of the last 30 control measurements To reject a control result select the result using the cursor keys or the mouse and select ALT F5 REJECT RESULT EXE ES Ss pel t LR kika S DR 5 4 VITAL SCIENTIFIC N V VITALAB Extended Routine 5 2 Program Controls The controls are programmed before the a
65. cases e Linearity error e Absorbance limit error e Reagent deviation error e Substrate depletion error e Prozone error The rerun is done with the defined rerun parameters Limits and volumes of each parameter are set in the SPECIAL FUNCTIONS PROGRAMMING TEST PARAMETERS menu Save before clear The analyzer automatically saves the result data on hard disk before clearing the main memory O All result data will be lost and replaced by new data Data in the main memory is automatically deleted if the storage capacity is exceeded or when reagents have been positioned on the reagent rotor You can also manually delete the main memory with ALT F2 Clear Result Buffer in the EVALUATE SAMPLES menu Wavelengths The eight wavelengths of the interference filters displayed as nanometer VITAL SCIENTIFIC N V 3 7 System Handling Basics VITALAB SSS values Only change this parameter if new filters have been installed Automatic evaluation analyzer automatically prints out all results Invalid results are marked as Reject L The analyzer blocks the patient s results with one or more error messages until you accept or reject these results in the EVALUATE SAMPLES menu The results are then printed out Automatic blank time The time hh mm at which the analyzer will do every day an automatic blank measurement of the cuvette rotor Enter the hours press ENTER enter the minutes and press ENTER again This measureme
66. chapter A great number of these can be solved without assistance from the technical service personnel Note a Check the error history before you the technical service See 6 3 4 6 3 1 Defective mixer belt If you notice invalid measuring results marked with a flag the cause of which is unclear the reason could be defective mixer belt It can be acoustically detected the typical sound is missing Moreover neither the sample needle nor the reagent needle rotates during mixing the reagent needle only rotates if reagent 2 was added The mixer belts must be checked daily before running the routine Replace the mixer belt if it looks worn or if it is broken 1 REMOVE the old belt from the support If the belt is destroyed remove the parts from the area around the cuvette rotor 2 Pull the new mixer belt part of the range of supply over the support until it is correctly positioned 3 Put the cuvette rotor lid back in its place 6 3 2 Sample needle clogged Take following actions if the sample needle is clogged 1 Press ALT F10 2 Carefully pull the tube consisting of an outer and an inner part off the sample arm Attention The sample needle has a double wall Do not push the double tube inwards when it is pulled off and put back into its place after cleaning 3 Take the stylet that is part of the range of supply and carefully push it into the inner needle from above until it comes out at t
67. check function VITAL SCIENTIFIC N V Extended Routine minimum ratio maximum ratio Ref male low Ref male high Ref female low Ref female high Ref ped low Ref ped high Ref panic low 5 12 Press ENTER and drop down list with all prozone options appears No e Min dAbs ratio e Min Abs ratio e dAbs ratio e Max Abs ratio If Min Abs ratio or Max ratio 6Abs Delta Absorbance is selected the analyzer calculates the respective delta absorbances of 2 x 3 measurement points at two different points in time prozone points 1 and 2 Both delta absorbance values are divided and then multiplied with the factor 100 delta absorbance proz point 1 delta absorbance proz point 2 x 100 The result percentage is called DELTA ABSORBANCE RATIO If Min dAbs ratio is selected and the result falls below the set minimum rate e g 80 or if the Max 8 Abs ratio is selected and the result exceeds the set maximum ratio the analyzer detects a prozone error and marks the corresponding result with a prozone flag If the Min Abs ratio or Max Abs ratio is selected the analyzer calculates the respective absorbance of 2 x 1 measurement points at two different points in time prozone points 1 and 2 Again both values are divided and then multiplied with 100 The further calculation operations are identical with those of the delta absorbance ratio If a prozone error is detected by
68. cuvettes are washed automatically there is usually no need to perform this function manually The manual rotor washing procedure is only necessary if for any reason the analyzer may be stopped ALT F10 while there was still reagent and or sample in the cuvette rotor If no new tests are performed immediately after stopping the instrument the rotor wash must be performed otherwise the cuvette rotor will dry up and residues will stick to the rotor wall 6 4 7 Needle rinse During the needle rinse procedure both needles will be cleaned more intensely with the Sputofluol solution The needle rinse procedure will take about 30 minutes Stop any processing of samples Select MAIN MENU F5 SPECIAL FUNCT F1 ROTOR SYSTEM ROTOR NEEDLE RINSE Press TAB or ENTER Place a 25 ml bottle with 10 Sputofluol on the reagent wheel Select REAGENT POSITION and assign the position of the reagent wheel NEEDLE RNSE Place a full sample tube with 10 Sputofluol on position no 1 of the sample rotor Select F3 NEEDLE RINSE DXX Urge Qo qo VITAL SCIENTIFIC N V 6 21 Special functions VITALAB SS eee a 6 22 VITAL SCIENTIFIC N V VITALAB Installation mmm Ts Installation VITAL SCIENTIFIC N V 7 1 Installation VITALAB 7 1 Hardware installation To operate the Analyzer with a PC the analyzer must be connected to the PC with the supplied serial cable 1 Switch the PC and the Analyzer off 2 Connect one end of the serial cable with COM
69. defined in the TEST PROGRAMMING menu Request a reagent for the blank determination 1 Select the parameter Sample Type 2 Select Blank from the drop down list A list of available tests is shown The list contains all tests that are previously defined in the TEST PROGRAMMING menu for a blank measurement 3 Select the required tests 4 Press F8 to transfer the request to the request buffer 4 1 9 Delete a request You can delete any request stored in the request buffer A request can only be deleted if it is not loaded with Confirm Load in the LOAD SAMPLES menu 1 2 Press F5 PREVIOUS SAMPLE or F6 FORWARD SAMPLE to show the required request The position of the actual sample in the request buffer is shown at the top left Press SHIFT F7 to delete the request from the request buffer When the request is deleted all following request numbers are moved up by 1 The screen shows the new request with the current number If you deleted the last request the screen jumps to the first request 41 10 Print a work list Press F1 to print the current work list The work 27 M R 2001 18 06 list shows these data Lab Name Time and date Number of stored requests Patient name Assigned tests The first column contains the sample type Calibration S Reagent Blank Request B Stat sample E Pediatric sample P or Control C 4 8 WORK LIST Number Name B Blank S SMT Calibrator S ISE Calibrator Cal
70. e calibration procedure From this curve the instrument uses the absorbance result to calculate a concentration The values of the standards must be programmed in the PROGRAM CALIBRATOR screen Extended Routine aa Main Menu Special Functions Rotor System SE Installati DUAL MODE 0 2260 0 2421 0 2554 02703 02790 0 2894 FIO Retum Main Menu Special Functions Rotor Spstem ISE Installation Absorbance limits ng ml dAbs m Low 02100 0 2200 High 0 2400 0 2600 0 0000 05000 1 0000 2 0000 3 0000 5 0000 ShiftsF1 F2 F10 e ke ps 0 2300 0 2500 0 2600 0 2650 02700 02900 0 3000 03100 F2 DISPLAY Display a graphical presentation of the calibration curve F1 PRINT Print out the calibration curve F2 CHANGE INACCUR Select the maximum value of imprecision Enter the values as a percentage 96 If the value is changed it is transferred to the test parameters A new calculation is made and the analyzer will adjust the curve VITAL SCIENTIFIC N V 5 21 Extended Routine Gw C VITALAB 5 6 Needie Cuvette Incompatibility To avoid possible cross contamination certain tests must never follow each other on the analvzer There is a difference between Needle incompatibilitv and Cuvette incompatibilitv The user sets the analvzer for compatible and incompatible tests Program the analvzer to t
71. e g filling level is near screw cap Foam is being produced REAGENT PIPETTING STOPPED The reagent needie could not be cleaned and therefore stopped pipetting Make sure HCI is installed on the reagent rotor and its bottle is not empty LAMP UNDERRANGE A counter overrange gt 29 000 is detected during a measurement Refer to hardware error LAMP FAILURE LAMP OVERRANGE A counter underrange lt 10 is detected during a measurement Refer to hardware error LAMP FAILURE LAMP UNDERRANGE REF CHANNEL A counter overrange gt 29 000 for the reference detector is detected during a measurement Refer to hardware error LAMP FAILURE LAMP OVERRANGE REF CHANNEL counter underrange lt 10 for the reference detector is detected during a measurement Refer to hardware error LAMP FAILURE INSUFFICIENT SAMPLE The safetv switch of the sample needie is activated sample cup emptv Liquid detection of the sample needle is not detecting anv liquid after aspirating the sample detection of air bubbles Hardware error messages Hardware error messages are displaved on screen and can be recognized bv an acoustic signal which can be stopped pressing the space bar The most important hardware error messages will be explained below Errors that can be eliminated bv the user himself will be described in detail In general manv errors cause other errors at th
72. e missing on Screen 3 Name The test name as set on Screen Page 1 Test Parameters Sample Blank Select whether to measure a sample blank in a separate cuvette for the corresponding test Obtain the information from the test method sheet as to if a sample blank measurement is needed Press ENTER in this field select Ves or No from the drop down list and press ENTER again to confirm If you select Yes screen pages 2 this page and 3 Mono Mode show fields for parameters regarding the sample blank For a description of these parameters see later in this chapter The sample blank reagent or dummv reagent is treated as a normal reagent regarding placement on the reagent rotor and incompatibilities The dummy reagent is distinguished from the normal reagent superscripted D in front of the reagent name TBIL normal reagent for Bilirubine DTBIL dummy reagent for Bilirubine Stand by DUAL Req bulfer 0 0 Reagent Disc ROUTINE Progam Test F2 3 3 01 35 19JAN 2001 6490 33 51 Test Parameters DUAL MODE MODE Main Menu Special Functions Total bilirubin Rotor Spstem ISE ves m 51 472 Installation 25 Quali Control Evaluate Samples Ves m Request Samples Load Samples 120 3 000 0 500 0 000 45 3 000 0 000 3 000 FI ShitsF3 FID Delete Test il 5 14 VITAL SCIENTIFIC N V VITALAB R1 bottle Normal Volume Re run Volume Sample n
73. e or the reagent disk menu For sample blank tests the test name 4 is left blank Message Blank result Direction analvzer host Format STX 4 wavelength 3 cuvet blank val 6 cuvet av 6 cuvet sd 6 lamp av 6 lamp sd 6 CR LF Explanation This message is sent the analvzer when the operator presses Ctrl F1 in the Rotor Svstem ISE Blank Rotor menu Command Echo request Direction host analvzer Format ST E ETX Response STX e device id 4 status 1 ETX CR LF Explanation status 1 0 success 7 failed message length error 8 failed overrun error 9 failed paritv framing or break error This message can be used as a test feature VITAL SCIENTIFIC N V 8 7 Appendix VITALAB isi Command Get software version Direction host analyzer Format STX V ETX Response STX v device_id 4 status 1 software version 6 18 ETX CR LF Explanation status 1 0 7 8 9 success failed message length error failed overrun error failed parity framing or break error Command Get reagent installation Direction host analyzer Format STX 1 ETX Response STX i device id 4 status 1 test 4 32 times ETX CR LF Explanation status 1 0 success 7 failed message length e
74. e same time For example a wash arm error E122 also causes a system halt E02 When the most obvious error is solved usually also the other error disappears VITAL SCIENTIFIC N V 6 7 Special functions O O VITALAB Error message Cause Action E02 SYSTEM EMERGENCY HALT For example the ISE arm was accidentally touched during measurement The analyzer immediately interrupts all operations Eliminate the error if possible and select SHIFT F6 SYSTEM RESET The analyzer then asks you on the screen whether the interrupted measurements the results of which were cancelled should be repeated E05 NO CLEAN CUVETTE If no clean cuvette is available the cuvette rotor e g caused by a vacuum error the wash arm with the dry block does not move down to the bottom of the cuvette to prevent contamination of the dry block Thus no clean cuvette is available in the analyzer Eliminate the error if possible for example clean and dry the rotor manually install a new one or refill it and select SHIFT F6 SYSTEM RESET lf the error occurs again inform the service technician E07 SYSTEM RESET INCOMPLETE Due to further errors the system reset was incomplete Eliminate the error if possible and select SHIFT F6 SYSTEM RESET to repeat a reset If the error occurs again inform the service technician E10 NO VACUUM The vacuum is not sufficient for a period long
75. e the values set in the TEST PROGRAMMING menu with the data given in the insert sheet of the test Prepare fresh calibrator or reagent solution if necessary C Control limit violation Compare the values set in the TEST PROGRAMMING menu with the data given in the insert sheet of the test Prepare fresh control or reagent solution if necessary N Reference limit violation The reference limit was exceeded Westgard rules limit violation Compare the results of the quality control of all controls set for this test Prepare fresh control or reagent solution or calibrate the test if necessary P Prozone error Repeat the measurement with pre diluted sample E Result near cut off The result lies within the set cut off deviation programmed in the TEST PROGRAMMING menu M Absorbance limit violation The limits set in the TEST PROGRAMMING menu are exceeded 5 32 VITAL SCIENTIFIC N V VITALAB Special functions Special functions VITAL SCIENTIFIC N V 6 1 Special functions SES C 6 1 VITALAB Select printers and set host connection If the analyzer is to be connected to a Lab EDP System or if a printer is to be installed connections and specifications of these devices must be defined 1 Select MAIN MENU F5 SPECIAL FUNCTIONS F2 INSTALLATION COMMUNICATION Parameters Result printer Use report layout Svstem printer Communication enabled Extended Format Device id 6 2 Stand by DUAL R
76. ecessary Check if the filter in the system liquid container is blocked and replace it if necessary If the waste container has been empty hold the water container and the pump unit at a higher level to assure that the water can reach the analyser more easily Service personnel only Check if the liquid level detection circuit is working correctly and repair it if necessary VITAL SCIENTIFIC N V 6 9 Special functions jA VITALAB Error message Cause Action E13 LAMP FAILURE A counter over range signal is detected during a measurement The signal counter over range signal is generated when the photocell signal is too low When the blank data values are incorrect too the gain setting of an input amplifier is wrong or an input amplifier is defective on the photometer board Select F1 CHECK AGAIN If the error occurs again check if the lamp is working and replace it if necessary Inform the service technician Service personnel only Check if the lamp voltage is present and well adjusted Adjust or repair the voltage supply if necessary Check if the selected filter is in the filament of the lamp If not check if the transport of the filter wheel is working correctly Find the failure by following the adjustment procedure submenu ELECTRONICS in the SERVICE menu if a defective or incorrect set input amplifier causes the problem Check that the lamp intensity is not too
77. ed VITAL SCIENTIFIC N V VITALAB Extended Routine mum Ref panic high The high panic limit of the reference ranges for all types of samples If a measured value is above this limit the analyzer flags the result on the print out if the report set up is enabled Note The respective Ref high value must always greater than the corresponding Ref low value If low and a high limit are identical the analyzer will not check these limits and will not flag the results Control 1 A maximum of three controls can be assigned to one test Press ENTER or Control 2 double click in one of the fields the analyzer displays the PROGRAM Control 3 CONTROL screen 1 Press ENTER to open the drop down list 2 Select one control and press ENTER again 3 Enter the Target value and the Low and High Limit The respective values are given in the insert sheet for the control Select Yes from the Westgard active drop down list to control the evaluation to Westgard rules 4 Confirm your entry and return to THE TEST PARAMETERS screen by pressing F10 RETURN Additional controls can be programmed as described above To delete a selected control press SHIFT F1 No CoNTROL in the PROGRAM CONTROL screen For test with qualitative evaluation method cut off the screen displayed below is shown Stand by DUAL Req buifer0 0 Reagent Disc ROUTINE Program Control 25712PM 19JAN 2001 buidUSS6i 1 Press ENT
78. ed or if the factor is exactiv 1 the analvzer automaticallv selects 3 decimal places In this case the unit is selected in accordance with the selected test method absorption for endpoint tests delta absorption for twopoint tests delta absorption per minute for kinetic tests Low Conc The value for the low limit of the measuring range from the method sheet If the value falls below of the set limit an error message is given High Conc The value for the high limit of the measuring range from the method sheet If the set limit is exceeded an error message is given or will retest using a lower sample volume Depending if Automatic Rerun is selected in SYSTEM PARAMETERS menu Calibrator Name If the test has to be calibrated a calibrator must be selected from the list of set calibrators Press ENTER and a drop down list with all calibrators appear Press ENTER again and select the appropriate calibrator using the cursor keys or the mouse After a calibrator has been selected the PROGRAM CALIBRATOR screen appears Refer to chapter 1 5 Prozone check The prozone effect can occur in tests based on the principle of the formation of an antigen antibody complex agglutination e g in Ig tests The effect often occurs in patient samples with a very high antigen content The surplus of antigen inverts the reaction direction de agglutination and causes incorrect measurement values for the sample To avoid this the analyzer offers a prozone
79. een carried Cuvette Blank report out V Isa sufficient amount of system liquid in Water container syringes the system Has the waste container been emptied Waste container s Was formation of foam avoided during Reagent bottles reagent preparation V Was formation of foam avoided during Sample tubes sample preparation VITAL SCIENTIFIC N V 3 13 System Handling Basics VITALAB Gw w wn SSS 3 14 VITAL SCIENTIFIC N V VITALAB Basic Routine Basic Routine VITAL SCIENTIFIC N V 4 1 Basic Routine VITALAB 41 Entering sample data and test requests 4 1 1 Requests Samples menu The REQUEST SAMPLES menu F8 contains all parameters for test requests and entry or assignment of patient samples You can quickly and easily enter sample and patient specific data and request the designated tests Recorded samples can later be edited or deleted If needed the analyzer prints a work list You can shorten the recording time with a barcode reader A difference must be made between recording with barcode in the REQUEST SAMPLES menu and recording with barcode in the LoAD SAMPLES menu You can scan the sample data from barcode labels on request forms The tests are recorded with the barcode request chart In the LOAD SAMPLES menu you can directly record data from the barcode labels on the sample tubes s 3 2 8 is pm primary tubes Parameters If you requested a calib
80. efer to S1 1 3 When you load samples with the barcode reader you must scan the labels in the required processing order of the analyzer Each scanned sample will be shown on the screen The sample is labeled with the relevant position number Warning m avoid mistakes place the sample on the indicated position on the sample rotor as soon as you have scanned the sample 4 2 4 REAGENTS INFO menu The REAGENTS INFO menu F5 shows the loaded reagents and their volumes Use this menu before you start the analysis run Parameters Pos Name ml Tests Tray Fill Keys F1 PRINT F2 CONFIRM REFILL ALT F3 CLR ALL COUNTS F5 COUNTER MODE F7 EVALUATE SAMPLES F8 REQUEST SAMPLES F9 LOAD SAMPLES F10 MAIN MENU Pos name fil 1 ISE diuent 17 2Digokn 2 ISEcondtone 00 3 ISEdeprten 00 4 ASAT GOT 00 5 Calcium 00 6 Totlbiubn 00 in 00 18 CReacivepo 00 192 CReacivepo 00 20 CKNAC 00 21 Cocain 00 222 Cocain 00 26 Check R 00 272 Check 00 282 CKNAC 00 cholesterol 00 I2 DualBichomast 0 0 32 DualBichromast 0 0 232 2Digoxin 00 302 Ak Phosphatas 00 312 Calcium 00 322 ASAT GOT 00 2 0 0 0 0 0 2 0 2 0 1 0 0 23 IgA 00 0 24 HCI01N 00 0 2 S 2 0 4 0 3 0 3 0 1 0 1 0 3 0 IR The positions of the tests on the reagent rotor FS F7 F8 F9 F10 1 Counter Eval Request Load Main Mode Sar Samples Sar Menu The name of the re
81. elect in the Screen saver field None 5 Press OK A Power management 1 Run WINDOWS EXPLORER 2 Select COMPUTER CONTROL PANEL PowER MANAGEMENT 3 Select Power Schemes tab 4 Select the Power schemes field Always on 5 Select the System standby field Never 6 Selectin the Turn off monitor field Never 7 Select in the Turn off hard disks field Never Also turn off the features for Power Saving supported in the BIOS Refer to the manual of the PC for instructions 74 VITALAB 2 xl Background Screen Saver Appearance Effects Web Settings Display Properties w l m Screen Saver forel Settings Preview Eassword protected Branger wet ia minutes Energy saving features of monitor To adjust the power settings for your monitor click Settings Settings Power Management Properties 2 Power Schemes Advanced this computer Note that changing the settings below will modify t Select the power scheme with the most appropriate settings for the selected scheme Power schemes always on 1 Delete Settings for always on power scheme System standby monitor Never Turn hard disks Never OK Cancel Apply VITAL SCIENTIFIC N V VITALAB 7 23 Install software Preparation 1 Exit all programs 2 Run WINDOWS E
82. en up to the age of 14 but this also depends on the patient and the test to be done Enter the name of the physician in charge who ordered the test or sample The default content of Physician name is the last entered VITAL SCIENTIFIC N V VITALAB Sample Tvpe Test displav Optional Kevs ARROW LEFT RIGHT ARROW UP DOWN TAB ENTER F1 WORK LIST VITAL SCIENTIFIC N V Basic Routine Ir name You can include this name in the data that is sent to a host The system parameter is set in the SPECIAL FUNCTIONS INSTALLATION menu Maximum length 20 characters Select the type of sample that is needed e Normal Normal patient sample The analyzer automatically positions on the outer two rings of the sample rotor The analyzer can process a maximum of 51 normal patient samples at one time without having to reload the sample rotor e STAT Emergency sample You can process a maximum of three Stat samples in one workload E1 E3 The analvzer positions these samples on the provided positions on the outer rings of the sample rotor The analvzer processes the Stat samples before all other samples e Pediatric Samples of children and teenagers For a pediatric sample you must select Pediatric at Sex Pediatric samples are processed directly after the Stat samples If you select pediatric in this field you must place the corresponding sample in one of the positions P1 to P5 after confirmation in the LOAD SAMPLES menu e
83. eq buffer0 0 Reagent Disc STANDARD Installation 122304 08 2001 buid 033105 Man Run mode Result printer Printer 7 Reagent Position DUAL MODE Use report layout Printerz x EXTERNAL RS232 HOST COMMUNICATION md SELECTION Reagent Position MODE System printer System Parameters Communication ISE Parameters 2 Deviceid 0007 Include range flags v Download physician v gt Communication Report Set Up Release Change reagent disc Select a printer for all patient results Select Off to disable printing of patient results temporarily Any printer supported by Windows can be selected The result printer will print patient results in a standard format if no report set up is defined or the report set up is disabled E The result printer uses the user defined report set up O The result printer uses the default report set up Select a printer for all non patient result data like graphs blank data calibration curves etc Any printer supported by Windows can be selected If both printers are set to Off no data will be printed 1 Enable communication with a host computer ON LINE O Disable communication with a host computer Default Use an extended format absorbance values are transmitted to the host along with the results Enter a four digit code for identification purposes All information sent to the hos
84. equest An empty screen is shown for adding the next request Na ASAT GOT Calcium Total bilirubin Alk Phosphatas Creatinine cholesterol Dual Bichromaat Glucose Urea 2 Digoxin C Reactive pro CK NAC Cocain Check R The number of requests waiting for analysis in the request buffer is shown at the top of the screen Req tray buffer You can now select the LOAD SAMPLES menu with F9 VITAL SCIENTIFIC N V VITALAB Basic Routine 4 1 3 Read samples and tests with barcode reader Preconditions A barcode reader is the easiest quickest and safest wav to request samples and tests and to load samples To use the barcode reader following preconditions must be met e Theprimarv tubes or the sample cups must have barcode labels e Therequested tests must be marked on the barcode request chart that is provided by the manufacturer The barcode label encodes the sample number so a manual entrv of the sample number is not necessarv when vou use a barcode reader Scan two barcode labels In some cases there are two barcode labels with identical patient data One label is e g on the sample cup and one is on a separate form If this is the case proceed as follows 1 Place the barcode reader on the sample label form of labeled barcode 2 Scan the code The sample number is shown on the screen 3 Place the barcode reader on the test that is selected on the barcode request chart 4 Scan the corresponding test barcode
85. er 3 000 abs If a value gt 0 was entered for the R2 bottle in the field normal volume this field will be displayed instead of R Abs Deviation Enter the value given in the respective method sheet If the reaction increases the analyzer adds this value to the point measured before reagent 2 was added the resulting absorbance is the high absorption substrate depletion limit for this measurement If the reaction decreases the analyzer subtracts this value from the last point measured before reagent 2 was added the resulting absorbance is the low absorption substrate depletion limit for this measurement If this value is exceeded while the analyzer measures the first four kinetic points the error message Substrate depletion will be displayed in the results report The analyzer uses all absorbance values to calculate a result that has not exceeded the programmed limit value VITAL SCIENTIFIC N V VITALAB Extended Routine 5 5 Calibrator parameter definition Stand by DUAL Req Aray buffer 0 0 Reagent Disc ROUTINE Program Calibrator 3 16 94 19JAN 2001 buid 09 361 albrator After a calibrator has been selected in screen page 1 of the test parameter programming screen all parameters that applv to this test must be programmed The following screen appears High 0 0000 ShifteF1 F10 o Calibr 5 5 1 Program Calibrator Parameters Repeat Defines a single duplicate or triplica
86. er stops all current operations The line analyzer status upper left side of screen displays the word HALTED Note Check the error history before you call the technical service See chapter 6 5 30 VITAL SCIENTIFIC N V VITALAB Extended Routine O 5 1 1 Error flags For certain errors the test results are marked with a flag The cause and necessary action are described below Further information about troubleshooting is given in chapter 6 3 Error flag Cause Action G General hardware error A hardware error Use the error list in the ERROR HISTORY was ignored by the operator menu to find the cause of this error Select F1 RESET SYSTEM in the RESET SYSTEM menu to clear this error Otherwise inform service R Insufficient reagent Fill the empty reagent bottle with reagent Press F2 Confirm Refil to confirm Insufficient sample Make sure the sample is of sufficient volume not coagulated and no air bubbles block the sample aspiration L Cuvette blank error Check the results of the last cuvette blank measurement in the BLANK ROTOR menu Repeat the blank measurement if required Lamp error Adjust or replace photometer lamp U Cuvette blank error Check the results of the last cuvette blank measurement in the BLANK ROTOR menu Repeat the blank measurement if required Underrange Adjust or replace photometer lamp O Cuvet blank error Check t
87. er than 2 5 seconds Vacuum pump defective Vacuum tubing defect or clamped Vacuum sensor defective or not well adjusted Select F1 CHECK AGAIN and inform the service personnel Check that the tubing that connects the analyser with the pump unit or the analyser with the bottles is not kinked or clogged Service personnel only Check if the vacuum pump is working properly and replace the membrane or the complete vacuum pump if necessary Check the vacuum tubing for leakage Check the vacuum sensor and re adjust it if necessary 6 8 VITAL SCIENTIFIC N V VITALAB Special functions Error message Cause Action E11 WASTE FULL The WASTE FULL signal is high for 1 second or longer Emptv the waste container Check if the waste container floating switch is working properly and replace repair it if necessary Check the wiring Service personnel only Check if the waste full signal detection signal is present on the system board When the signal is present malfunctioning of the system board may cause the problem E12 WATER RUNNING OUT The upper level detector detects No water in the water container although the pump is switched on for a period longer than 25 seconds Check if there is enough system liquid in the water container and refill if necessary Check if the water tubing is leaking or blocked and repair or replace defective tubes if n
88. eration Only refill the coolant in large intervals since the coolant circulates in a closed liquid cycle Refill the liquid if the LED flashes and or an acoustic signal is heard VITAL SCIENTIFIC N V 3 9 System Handling Basics VITALAB 1 Attach the connection tubing to the cooling unit and analyzer as shown in the figure 2 Install the power cable to the back of the unit The unit can run with either 110 or 230 V device dependent 3 Switch on both switches on the front of the cooling unit before you switch on the analyzer Recommendations to ensure a steady cooling of the reagent rotor e Constantly keep the unit in stand by mode e Cover the unloaded rotor positions with the supplied caps 3 2 6 Fill Remove System Liquid To prepare the analyzer for operation you must fill the entire liquid system with water Use this menu to make sure that the analyzer is filled with water Also use this menu when you rectly fot tty again must remove water from the analyzer e g for venerat transport purposes DI Fill the water container with 25 ml of system liquid and 10 of distilled or de ionized water Use water with a conductivity of less than 30 uS and a microbial count of less than 10 CFU ml For transport preparation empty the analyzer liquid container and the waste container s 3 10 VITAL SCIENTIFIC N V VITALAB System Handling Basics System Select F5 SPECIAL FUNCTION F1 ROTOR SYSTEM F
89. eters As separators might be used 20 21 3cH 40H 5bH 60H 7bH 7eH Valid European Values are 1 3 92 01 03 1992 1 3 92 1 Mar 1992 Valid America values are 3 1 92 03 01 1992 MAR 1 92 3 1 92 Mar 1 1992 8 9 gt sex 1 request test 1 VITALAB M Male F Female P Pediatric 32 row of at most 32 0 1 0 don t request the test 1 request the test Sample blank tests are internally in the analyzer but not in the indication automatically set to 1 if appropriate If one or more Na K or Cl tests are selected the analyzer will measure all three and will send all three results status 1 0 success request created or tests added to existing request with the same sample number etc 1 failed sample number already exists but demographic information doesn t match or request in use by the operator 2 failed no space for request 3 failed one or more tests requested which have not been installed 7 failed message length error 8 failed overrun error 9 failed parity framing or break error Command Delete request sample Direction host analyzer Format STX D Sample nr 1 12 ETX Response STX d device id 4 status 1 Sample nr 12 sample info ETX CR LF Explanation status 1 0 success 1 failed sample number not found already loaded or in use by the operator 7 failed message length e
90. eters Use the cursor keys or the mouse to select the Stand by DUAL Req Aray buffer 070 Reagent Disc ROUTINE installation 10 51 44 18JAN 2001 build 0 9 3 51 Main gt System Parameters ISE Parameters ave 376 405 parameters Enter the value and confirm Y Baaz with ENTER t b cuvet blank SD 00200 Normallv enter these parameters only once Needeieiierat G daw K Print only per teste Ii before the analvzer goes into operation However you can change the parameters whenever necessary e g the date format Special Funct Parameters Language Select the language used Lab Name Type the name of the laboratory The field is 32 characters in size The name is shown on every result printout Date Format Select the date format The date is shown on the monitor and on every printout dd mmm yyyy e g 13 JUN 2000 mmm dd yyyy e g JUN 13 2000 dd mm yyyy e g 13 06 2000 mm dd yyyy e g 06 13 2000 Sample no auto incr amp Select the sample counter to automatically increase the sample number in the REQUEST SAMPLES menu when patient samples are recorded Alphanumeric data is always counted up The analyzer counts the sequence e g from Az99 up to 00 Automatic Re run Select the automatic rerun to automatically schedule a test with the rerun parameters of the respective test when the defined limits are exceeded The rerun applies to the following
91. ets of the reagents Certain tests must not be run in succession since the danger of carrv over is verv high Select the tests not to be run in succession in the TEST INCOMPATIBILITV menu All reagent positions on the reagent rotor that are currently used must be programmed in the analvzer Use the INSTALLATION menu In order to avoid delavs in routine operation it is recommended to check the volumes of the loaded reagents dailv Reagent Info If the analvzer is run both in the Mono Mode and in the Dual Mode the required reagent positions must be programmed separatelv for both modes REAGENT POSITION MONO MODE menu and REAGENT POSITION DUAL MODE menu Select the profiles in the PROFILES menu if vou want to use profiles for the recording of patient samples If the analvzer is run both in the Mono Mode and in the Dual Mode the required profiles must be programmed separatelv for both modes REAGENT POSITION MONO MODE menu and REAGENT POSITION DUAL MODE menu It is recommended to empty the waste container and to fill the water container before you start the daily work Thus you avoid interruption of the routine work The analyzer stops the operation if the water level is too low or the waste water too high The analyzer continues again when the required liquids are filled up or emptied Do a cuvette rotor blank measurement once every day This measurement is carried out automatically if the respective settings have been made in
92. ewing the middle and bottom screw with the two screwdrivers in such way that the Cuvette bar on the screen is on Max If you turn the screws carefully you can see the bars in the display move up and down Turn the screws until the bars reach maximum height They should not show infinity signs however The values must be at least equal to the minimum 9 Check whether the lamp intensity is too high for each filter 1 Select F1 CHECK Cuv ABs The system measures the cuvette absorbance for each filter and displays the values graphically on screen The value must be equal to or higher than the minimum value i e each bar on the screen has to be at or above Min 2 Reduce the lamp intensity by turning the middle and bottom screw if each bar is not at or above Min Select F1 CHECK Cuv ABs again and compare the heights of the bars Repeat the procedure as often as necessary until all filter values are equal to or higher than Min Close the front door Place the safety screw o Select F10 RETURN to quit the ADJUST LAMP menu VITAL SCIENTIFIC N V 6 19 Special functions VITALAB 6 4 5 Replacing syringes and syringe tips The accuracy of the system highly depends of the state of the syringes especially the sample syringe It is therefore necessary to check their state regularly and replace the Teflon tips sealing or the complete syringes if required There are two clear indications for defective syringes e Imprecise resul
93. function 22 points 1 to 22 are available in the Mono Mode 21 points 1 to 21 in the Dual Mode The absorbance values are marked on the y axis If the cuvette reagent plus sample contains less than 220 ul during the measurement of a point e g before the sample or reagent 2 is added these measurement points will not be shown on screen The measurement points in the coordinate system have following functions Used measurement point e Unused measurement point o Theused slope point for the slope blank calculation or the used prozone point depending on the display mode Measured reagent absorbance x Extrapolated value reagent deviation only used for sample start methods with falling kinetics or two point kinetics Ri 2 Reagent absorbance E 2 First or second measurement point in endpoint tests 1 Measurement for the first wavelength 2 Measurement for the second wavelength In bichromatic endpoint tests point 2 is subtracted from point 1 In monochromatic endpoint tests the average of point 1 and point 2 is calculated Depending on the type of test method the following absorbance is shown e Calculated absorbance endpoint e Delta absorbance two point e Delta absorbance per minute kinetic The number of measurements for kinetic or two point measurements depends on the mode e Mono mode 22 measurements 1 22 e Dual mode 21 measurements In endpoint tests monochromatic or bichromatic
94. gned as open systems Open implies that most clinical chemistry tests and techniques that require photometric measurement can be adapted on the system Only the test parameters for a specific test need to be adjusted The user needs to establish the required test parameter settings to achieve satisfactory results utilizing appropriate methods The methods are preferably based on international guidance documents for example ECCLS or NCCLS guidelines Vital Scientific N V does not suggest or propose any particular reagents calibrators and or controls on their analyzers from a specific manufacturer Obtain information on the performance characteristics from the selected reagent distributor and or manufacturer Various reagent manufacturers have performed performance studies on the Vitalab series in combination with their reagent kits Therefore they have application sheets available for various analytes The required information usually can be obtained from the reagent package inserts Please contact your local representative and or reagent manufacturer for further information on the chemical performance of their reagents on Vitalab analyzers Disclaimer Vital Scientific N V assumes no responsibility for erroneous test results caused either by the reagent kits and or calibrators or for inadequate use and determination of test parameters 2 9 2 Analyzer Technical Data Dimensions and weight Width 115 cm Depth 56 cm Height 49 cm Weight
95. he end of the needle 4 Carefully move the stylet up and down several times to remove all substances that block the needle Do not dispose the stylet afterwards When the tube is put back into its place ensure that the outer protective tube is not pushed into the opening of the needle cover Only the inner tube has to be pushed into the needle cover After the tube has been correctly fixed and the analyzer has been reset operation can be continued 6 4 VITAL SCIENTIFIC N V VITALAB Special functions 6 3 3 Removal of rotor tray Should you detect any liquids or objects on the bottom of the rotor trays sample and reagent tray the respective tray must be removed and cleaned 1 Press ALT F10 2 the screw cap counter clockwise until it can be removed 3 Remove the tray 4 Now clean the bottom of the rotor tray or remove the object from the rotor tray After putting back the rotor do not forget to place the screw cap turn clockwise 6 3 4 Error history 1 Note m Malfunctions are often caused by the fact that the mentioned cleaning procedures were not performed often enough i e not in accordance with the maintenance plan You can check the needle rinse history by activating the corresponding item in the SERVICE menu Use this function in case of problems to inform the technical service what type of error ere e M and error number has occurred E hi 184AN 20
96. he calculation are shown as empty squares Measurement points which were not used for the calculation on the other hand are shown as filled circles Press F2 to show the values of the measurement points in tabular form The individual absorbance values and the resulting delta absorbances are shown The measurement points used for the delta absorbance are marked with arrows You can now accept the result with F3 reject it with F4 repeat the measurement with F5 or run the test again with F6 If you select F6 the analyzer uses the sample and reagent volumes for the rerun as they were entered when programming this method in the TEST PARAMETERS menu 4 24 VITAL SCIENTIFIC N V VITALAB Extended Routine Extended Routine VITAL SCIENTIFIC N V 5 1 Extended Routine VITALAB 5 1 Quality Control The QUALITY CONTROL menu gives an overview of all measured control data Any one of three controls previously assigned to the test in PROGRAM CONTROL can be selected to view the test in Graphic Mode e g for stability and can be printed This is not available for incomplete tests The PROGRAM CONTROL can be selected from QUALITY CONTROL to change the assignment of controls and return to QUALITY CONTROL This is available during measurement 5 1 1 Start Quality Control Select F10 MAIN MENU F6 QUALITY CONTROL Stand by DUAL Req tray buffer0 0 Reagent Disc ROUTINE Qualiv Contol 14205PM 1SJ N2000 buid 03361 Precinorm U 199451
97. he respective data sheets The compatibilitv of tests must be checked and re set when new test parameters are programmed Select from the MAIN MENU F5 SPECIAL FUNCTIONS F3 PROGRAM NEEDLE INCOMPATIBILITV or CUVET INCOMPATIBILITV Incompatibilitv parameters Needle incompatibilitv ALT LDH Cuvette incompatibilitv ALT LDH The reagent needle will not aspirate the LDH reagent immediately after the ALT reagent The analyzer selects another test to be aspirated If not HCI will be aspirated as an extra cleaning step A cuvette will not be used for the LDH test after ALT test The analyzer selects another test for this cuvette If not HCI will be dispensed as an extra cleaning step This is after 48 cycles later Note Be careful in setting incompatibilities as it decreases the throughput of the analyzer Please consult your reagent supplier and or distributor first before programming incompatibilities 5 6 2 Display of Incompatibilities The program procedure and display screen are identical for needle and cuvette incompatibility All tests programmed in the analyzer are displayed on two pages Incompatible tests are listed behind the respective abbreviate name of the programmed tests A maximum of seven different tests can be set for each individual test Keys ENTER CURSOR KEYS DOWN F1 F3 DELETE F5 LINK F6 INCOMP F10 RETURN 5 22 DUAL Req Aray bulferO 0 Reagent Disc R
98. he results of the last cuvette blank measurement in the BLANK ROTOR menu Repeat the blank measurement if required Overrange Adjust or replace photometer lamp U Cuvet blank error Check the results of the last cuvette blank measurement in the BLANK ROTOR menu Repeat the blank measurement if required Underrange reference detector Inform service Error in electronics Inform service Cuvet blank error Check the results of the last cuvette blank measurement in the BLANK ROTOR menu Repeat the blank measurement if required Overrange reference detector Inform service Error in electronics Inform service Cuvette temperature error Inform service R Rerun A test was re run with pre diluted volume Non linearity error A non linear reaction of kinetic tests on the first four measurement points VITAL SCIENTIFIC N V 5 31 Extended Routine VITALAB mH Error flag Cause Action X Concentration limit error The limit set in the TEST PROGRAMMING menu was exceeded D Reagent absorbance deviation error Select F6 RERUN MEASUREMENT in the EVALUATE SAMPLES menu The limit set in the TEST PROGRAMMING Select F6 RERUN MEASUREMENT in the menu was exceeded EVALUATE SAMPLES menu A Reagent absorbance limit violation Make sure the limits in the TEST PROGRAMMING menu are correct Prepare fresh reagent solution if necessary A Calibrator limit violation Compar
99. he sample number 2 The analyzer assigns a position number to the selected sample Place the sample in the relevant position of the sample rotor 3 Load all other samples in the same way Note a The washing position W must contain a tube with washing solution 10 Sputofluol solution for each analysis run The pediatric adapters and the small cups can be used for all types of samples i e pediatric samples standards controls and normal patient samples Do not place the small cups directly in the sample rotor without an adapter because then the liquid sensor of the sample needle will not work You can also enter the sample number manually with the keyboard A barcode reader can record the sample numbers directly from the barcode label on the sample tube Load sequence When you place the samples in the sample rotor you do not have to use the same sequence as the processing sequence that is defined in the REQUEST SAMPLES menu Use the ARRoW UP DowN keys to select the sample Press PAGE UP or PAGE DOWN to scroll through the screen Press ENTER to position the sample The analyzer will process normal samples and controls in this order Blanks calibrators Stat samples and pediatric samples however are always processed first VITAL SCIENTIFIC N V 4 11 Basic Routine VITALAB 4 2 3 Load samples with barcode reader A barcode reader is the easiest quickest and safest way to request samples and tests and to load samples R
100. he system will reset the counter to zero 13 Perform a cuvette rotor blank measurement 6 16 206 40PM_ Z2JAN 2001 Stand by DUAL Req Aray buffer 0 0 Reagent Disc ROUTINE Blank Rotor Table Mode Graphic Mode Quality Control Evaluate Samples Request Samples Load Samples 0 3504 SD 0 0059 Lamp AV 22780 SD 0 0019 Last blank date 22JAN 2001 time 4 16 00 F10 i N Ke R Retum i VITAL SCIENTIFIC N V Special functions 6 4 3 Manual Cuvette Rotor Blank Measurement Once a day a cuvette rotor blank measurement must be performed The analyzer can carry this out automatically if the Automatic Blank Time was set in the SYSTEM PARAMETERS menu For an automatic blank measurement the analyzer has to be in the stand by mode Cuvette rotor blank measurements can also be performed manually It has to be carried out manually after the first installation of the system and after replacement of the cuvette rotor see previous section A manual cuvette rotor blank measurement is started in the BLANK RoToR menu After the menu is called up the system displays all absorbance values for the 48 cuvettes The values for the cuvette AV and the lamp AV are displayed together with the respective standard deviations SD Reset System Change measurement disc Change Syringes Fil Empty System F MOSE Clean System The g
101. ific meaning of each of these symbols is described below Symbols in the manual ATTENTION Warning Failure to follow information contained in warning messages could lead to serious personal injury and or damage to the analyzer Note Notes contain additional information corresponding to the text VITAL SCIENTIFIC N V 1 3 Safety Precautions and Potential Hazards 1 3 1 3 1 V 1 3 2 Vv 1 3 3 1 3 4 A 1 3 5 Hazards Electrical hazards ATTENTION Warning To prevent the risk of electrical shock and or damage to the instrument Operators should not open the covers of life parts electrical of the instrument Only authorised personnel for example service technicians may open the instrument to perform maintenance or repair Touching the life parts when the power is on may cause severe injury or death Mechanical hazards ATTENTION Warning DO NOT wear loose garments or jewellery that could catch in mechanisms DO NOT put your fingers hands into the pathway of any part while the analyzer is in operation DO NOT attempt mechanical repair unless the instrument is not in operation or OFF Sample and Reagent arms ATTENTION Warning Do not touch movable parts of the system rotors arms etc while they are in motion Particular attention and caution must be paid to sample and reagent needles Although the greatest possible safety precautions were taken these parts still are potentially hazardous H
102. in the second cuvette The sample volume set in the test parameters refers to the volume of the diluted sample The instrument itself determines how much concentrated sample and diluent will be picked up Kinetic Measurement Mode Press ENTER to open a drop down list with incubation times values in seconds 5 15 Extended Routine VITALAB If only reagent 1 is used the incubation time is the time interval between the addition of the sample and the beginning of the first measurement If reagent 2 is used the incubation time is the time interval between the addition of the last reagent and the beginning of the first measurement Select a minimum measuring time from the second drop down list If no linearity error has been detected on the first four measurement points after the incubation delay time and during the minimum measuring time the analyzer uses all the measurement points that were measured during the minimum measuring time E g 50 seconds is entered as delay and 186 seconds for the minimum time the analyzer measures the first point after 50 secondsand the last point 186 seconds later If the instrument detects a linearity error after the first 4 measurement points the analyzer uses as many points as possible for the calculation even after the minimum time In both cases linearity error or no linearity error the analyzer uses as many measurement points as possible min 4 until either the curve decreases the abs
103. inserts or product information sheets for specific instructions 1 5 5 Disclaimer Vital Scientific N V assumes no responsibility for erroneous test results caused by reagent kits calibrators and or test parameters that are not provided by Vital Scientific N V 1 5 6 Controls Vital Scientific N V recommends the use of quality control solutions with known values for each test in accordance with international regulations and guidelines Results obtained should fall within the limits defined by the day to day variability of the system as determined in the user laboratory If the results fall outside the laboratory s established limits refer to the troubleshooting information in this manual or contact your agent 1 5 7 Analytical results The analytical results do not only depend upon correct operation of the analyzer but also on a variety of external influences beyond the control of the manufacturer Therefore the test results obtained with this instrument must be carefully examined by an expert before any measures are taken based on the analytical results Warning V ATTENTION Warning An incorrectiv measured result may lead to an error in diagnosis thereby posing a danger to the patient VITAL SCIENTIFIC N V 1 7 Safety Precautions and Potential Hazards VITALAB Gw _ 2 a Z Es 1 8 VITAL SCIENTIFIC N V VITALAB Introduction Introduction VITAL SCIENTIFIC N V 2 1 Introduction VITALAB 2 1 Intended use The Vita
104. ion or Enzyme factor from the method sheet must be entered here The factor is negative for a decreasing reaction If a method uses a one point calibrator the factor is automatically calculated and displayed in this field If the factor is exactly 1 000 the analyzer concludes that the test was never calibrated The results of this test are printed out with 3 decimal places and the unit abs dabs or abs m depending on the type of test endpoint twopoint kinetic Select whether or not a reagent blank measurement is to be used Press ENTER select Yes or No from the drop down list and press ENTER again to confirm If you selected to carry out a blank measurement a number after Yes appears that will contain the results of the reagent blank after measurement The reagent blank is the unspecific change in absorbance of the reagent solution if water is used as the sample The result is subtracted from the absorbance change of the reaction with the sample Note Do not confuse the reagent blank with the absolute absorbance measurement of the reagent which automatically takes place for every test provided R1 volume gt 220 The low absorbance limit to be used If a measured absorbance value is below this limit the analyzer flags the result An automatic rerun of the test starts if the Automatic Rerun option was selected in SYSTEM PARAMETERS The high absorbance limit to be used If a measured absorbance value is above this limit the anal
105. iquid The actual temperature of the reagents will be slightly higher The user cannot change the temperature setting of the cooling unit 2 8 VITAL SCIENTIFIC N V VITALAB Introduction LI CEE Eee 2 6 Barcode reader Caution Switch off the computer before vou install the barcode reader The barcode reader can be connected to the kevboard of the external PC The reader is used for test requisition and randomized loading of the samples Most of the available barcodes can be read but Codabar gives the highest convenience The Codabar start character is used to differentiate between tests and profiles VITAL SCIENTIFIC N V 2 9 Introduction VITALAB 27 Operation requirements Only a qualified service technician may unpack the analyzer cooling unit and other devices Vital Scientific N V does not take responsibility for damage or improper operation of the analyzer when these instructions are not observed The analyzer is inspected and ready for use when it is handed over to the user Use the analyzer in closed rooms It must be placed on a flat horizontal surface that is not subject to vibrations Avoid exposure to direct sunlight The electrical connection has to be grounded according to common regulations to ensure proper operation of the analyzer The analyzer is compliant with the requirements of the applicable EMC standards Electronic equipment that exceed the radiation limits defined in the EMC standards like GS
106. is recommended to backup files every day or week For backup save the following files on a disk e system information all dat files in the folder C Program Files Analyzer e The patient results all txt files in the folder C Program Files Analyzer e The test parameters QC reagent blank and calibration data all dat files in the folder C Program Files Analyzer Standard After a crash place the files back on the locations as mentioned above Note only dat files from the same date shall be copied back Using dat files from different dates may result in a corrupted database error and the dat files become unusable VITAL SCIENTIFIC N V 7 9 Installation VITALAB wn gt gt qVvx 7 10 VITAL SCIENTIFIC N V VITALAB Appendix Appendix VITAL SCIENTIFIC N V 8 1 Appendix VITALAB 8 1 Interface Description Data formats and transmission instructions for the communication between the analvzer PC and a host computer are described in the following 8 1 1 RS 232 Description The line signal definition is shown in the following table DB 25 Signal name direction remarks pin 7 SG Signal Ground 2 TX Transmit data output data from analyzer PC to host 3 RX Receive data input data from host to analyzer PC 4 RTS Request To Send output 5 CTS Clear To Send input J 20 DTR Data Terminal Ready output 6 DSR Data Set Ready input 8 CD Carrier Detect input not used 22 RI Ring Indicator i
107. istilled water Remove cuvette cover and check wash arm mixers and cuvette rotor visually If the ISE option is used fill tube in ISE position with human sample activator gt WEEKLY Perform needle rinse procedure cleaning of sample and reagent needle with Sputofluol 10 Check syringes and tips air bubbles and leakage clean syringes replace tips if necessary SEMI ANNUAL AS NEEDED MONTHLV 1 Clean water and waste container s with 0 1 mol l NaOH Afterwards rinse several times with water QUARTERLV 1 Replace mixer belts If not done by the service technician during preventive maintenance 2 Replace water filter 3 Replace drying block on wash arm 1 Runthe clean system procedure with 100 Sputofluol During the clean system procedure the instrument is completely rinsed with a concentrated cleaning solution which takes about 3 hours during which the operator has to change liquids and tubings a few times Because tubings or valves might clog during the clean system procedure it should only be performed after consulting your supplier 1 Replace cuvette rotor after 10 000 tests or after SD error after cuvette blank 2 Replace lamp VITAL SCIENTIFIC N V 6 15 Special functions 6 4 2 Replace measurement disk VITALAB The measurement disk cuvette rotor must be replaced after 10 000 tests or when an SD ERR appears on the print ou
108. lab analyzer is an automatic chemistry analyzer used in combination with certain reagents for in vitro diagnostic measurement of analytes in samples of serum plasma urine and aqueous standard solutions The analyzer is designed as an open system Most clinical chemistry tests that require photometric measurement can be adapted on the system The Vitalab analyzer is intended for use in clinical chemistry laboratories where the workload is of medium quantity The analyzer has to be operated by trained professionals Disclaimer Depending on the specific characteristics of the involved reagent kit the results obtained from a clinical chemistry system may vary The test parameters for each test and each reagent supplier need to be developed by appropriate methods for example using ECCLS or NCCLS guidelines before the system is used for actual measurements of patient samples Vital Scientific N V takes no responsibility for erroneous test results caused by reagent kits and or test parameters that are not provided by Vital Scientific N V ECCLS European Committee for Clinical Laboratory Standards NCCLS National Committee for Clinical Laboratory Standards USA 2 2 VITAL SCIENTIFIC N V VITALAB Introduction 2 2 System presentation The Vitalab analyzer is a universal system The price performance relation is optimized for small and medium workload up to 180 tests per hour or even up to 270 tests per hour when the optional
109. lts are available e Loaded The sample is in the trav buffer but processing has not vet started e ToBeSent This message appears only if the analvzer is connected to a Laboratory Information Svstem LIS The results can be sent to the host computer e Printed The result was printed e Deleted The result was rejected VITAL SCIENTIFIC N V 4 15 Basic Routine M VITALAB Test Displays Normal Mode All tests of a sample are shown together with their measurement results and their units The screen shows up to 28 test results without sample blanks per patient in the normal mode In the graphic mode a maximum of 32 tests including sample blanks are shown If the word INFO is shown next to the corresponding test you must press F7 to validate the result Press F3 to accept the result or F4 to reject the result F5 to repeat the measurement or F6 to re run the test with a specific rerun volume Parameters on right side of screen Entrv Field Displav Fields Kevs F1 PRINT SHIFT F2 CLEAR RESULT BUFFER F3 BLK CAL INFO SHIFT F4 CANCEL REQUEST F5 Ev DISK SANPLES F6 QUALITY CONTROL F7 GRAPHIC MODE F8 REQUEST SANPLES 9 LOAD SAMPLES F10 MAIN MENU 4 16 When you enter a specific sample number this sample is shown on the left side of the screen with the results If the word INFO is shown instead of a result you must validate the result manually All samples that have been or are currently being proce
110. luate Samples F8 Request Samples F9 Load Samples F5 SPECIAL FUNCTIONS F1 Rotor System ISE F2 Installation F3 Program F4 Service F6 Quality Control F7 Evaluate Samples F8 Request Samples F9 Load Samples F10 Main menu F6 QuALITY CONTROL F4 Program Control F6 Graphic Mode F7 Evaluate Samples F8 Request Samples F9 Load Samples F10 Main Menu F7 EVALUATE SAMPLES F1 Print SF2 Clear Res Buffer Blank Calibrator Info SF4 Cancel Request F5 Evaluate Disk Samples F6 Quality Control F7 Graphic Mode F8 Request Samples F9 Load Samples F10 Main Menu F8 REQUEST SAMPLES F1 Load List F2 Stat F3 Profile F4 Repeat Mode F5 Prev samples F6 Forward Sample SF7 Delete AF7 Delete All F8 New Sample F9 Load Samples F10 Main Menu F9 LOAD SAMPLES F1 Load List F2 Select Unload F3 Confirm Unload F5 Reagent Info F6 Quality Control F7 Evaluate Samples F8 Request Samples F9 Update F10 Main Menu VITAL SCIENTIFIC N V 3 3 System Handling Basics 3 1 3 Parts of the screen Total bilirubin Phosphatas Date of birth Creatinine T cholesterol DualBichromaat kx Sex Phy Sample Prev Shift F7 F6 Alt F7 Forward Delete Del All 5 1 Status line 2 Input area with functions 3 Function keys F1 to F10 Status line VITALAB The information on the status line
111. lues set for the selected test 4 Make the necessary changes to the parameters 5 Select F10 RETURN to return to TEST PROGRAMMING menu 6 Select F10 SPECIAL FUNCTIONS to return to the SPECIAL FUNCTIONS menu 5 10 VITAL SCIENTIFIC N V VITALAB 5 4 2 Program Test Parameters The programming of twopoint and endpoint tests is for most parameters identical to kinetic tests However depending on the selected measurement mode Kinetic two point endpoint some fields are not applicable and are therefore not displaved Differences are described in the following section Extended Routine The name of the test You must enter text to this field If no name is entered the test parameters will not be stored Abbr Name The abbreviated form of the test name You must enter text to this field If no name is entered the test parameters will not be stored Mode Select the measurement mode from the drop down list Kinetic Endpoint Twopoint Wavelengths Select the wavelength as given in the method sheet from the drop down list The dropdown list contains all available wavelengths For a monochromatic endpoint measurement both wavelengths must be identical Units Select the desired units from the drop down list All test results will be displaved and printed using this unit Decimals Select the number of decimal places for patient or control data used in display and printout If the test has not been calibrat
112. ments However it is important that the maintenance procedures are strictly followed All maintenance steps are described in the following table V Attention Liquid waste is potentially infectious and can be hazardous to health It must be disposed of according to national and international instructions for the safe disposal of biohazardous waste All laboratory specific safety precautions have to be strictly followed for the cleaning of the analyzer since contamination with infectious materials can never be fully excluded 6 4 1 User Maintenance Perform the daily maintenance before daily routine There is no end of day procedure that must be followed Just before going into standby mode the instrument will automatically clean the reagent needle with the HCl solution that is on the reagent wheel and the sample needle with the Sputofluol solution that is on the W position on the sample wheel Perform the weekly maintenance at the end of the week DAILY 1 Fill water container with system liquid and distilled water 25 ml system liquid on a full 10 liter container Empty the waste container follow the safety instructions for working with potentially infectious materiall Check cuvette rotor blank results Replace cuvette rotor if necessary Check printer paper Fill HCl bottle in the reagent rotor with 0 1 mol l Fill tube in W position of sample rotor with Sputofluol 1096 Fill tube in B position of sample rotor with d
113. ments are lost Vou can repeat these measurements afterwards 3 1 5 Messages If an error occurs in the analyzer or the operation routine the analyzer displays an error message on the monitor The message is accompanied bv an acoustic signal The message gives information about the error and where possible instructions how to solve it Example E12 water running out shows when the analvzer liquid is low Vou must fill the water container The analvzer will continue the interrupted operation without further consequences Refer to Messages in chapter 4 3 2 Start the analvzer for the first time Warning Do not install the analyzer yourself The analyzer must be installed by trained personnel After installation and before you can use the analyzer in normal routine operation several system adjustments must be made 3 2 1 Prepare the analyzer Do following operations in this sequence clos D Ot come N VITAL SCIENTIFIC N V Start the analyzer Refer to 3 2 2 Install PC and analyzer software Refer to chapter 7 Connect the cooling unit Refer to chapter 3 2 5 Fill the system with system liquid Refer to 3 2 6 Set up the system parameters and the run mode Refer to 3 2 3 and 3 2 4 Program the calibrators Refer to chapter 5 Load or program the test parameters Refer to chapter 5 Program the controls Refer to chapter 5 Define the incompatible tests Refer to chapter 5 Program the profile
114. mol l Sample Name Charles Brighton Date of bith 31 MAY 1965 Sex M Physician name Sample Type Normal IN PROCESS 5 READY REFER LIMIT ERROR L 0 0 H 170 0 an Wena Special Functions Sample Number 27032001 010 ol Rolor Spstem ISE Sample Margret Betterbury Installation Date of bith 24 NOV 1953 Sex F Physician name Dr Livingston Sample Type Normal READY VITAL SCIENTIFIC N V VITALAB Ifthe prozone check has been selected for a test press F2 again in the table mode to show the graphic of the prozone check Six points of the 21 measurement points were used for the calculation of the prozone check 2 x 3 These measurements are shown as circles The marks the measured reagent absorbance Press F2 again to show the table of the prozone check Here the values of the graphic are shown as figures The analyzer calculates the slope ratio of the first three used points 5 6 7 and of the second three used points 18 19 20 respectively The points used for the calculation are marked with arrows The column R states the measured reagent absorbance 4 3 3 Automatic Results Printout Sample Number 27032001 010 Sample Name Margret Betterbury Date ofbith 24 NOV 1953 Sex F Physician name Dr Livingston Sample Type Normal READY Basic Routine ial Functions Rotor System ISE Sample Number 27032001 010 Sample Name Margret Betterbury Date of bith 24 NOV 1953 Sex Ph
115. n mode appears Select a profile from the list and press ENTER All tests defined in that profile will be added to the current list of tests You can program the profiles in the PROFILES menu Subsequent requests use the same set of test selections as default as the current one Show the previous request in the request buffer Show the next request in the request buffer Delete the request that is currently shown on the screen The numbers of the following requests in the request buffer are changed accordingly Delete all requests from the request buffer Store the current request in the request buffer and clear the screen for a new request If you selected the parameter Sample no autom incr in the SYSTEM PARAMETERS menu the sample number will increase automatically If F4 REPEAT MODE is on tests selected at previous patient will automatically be selected at current request Go to the LOAD SAMPLES menu loading of the sample rotor Manually enter samples and test requests Always enter a sample number The analyzer rejects requests without a sample number Enter the Sample Number Enter the Sample Name and the Date of birth if the laboratory is patient oriented These data are printed on each result report You can change the date format in the SYSTEM PARAMETERS menu Enter the other parameters if required Or Press TAB to go directly to the test selection area Select the required tests Press F8 to store the r
116. nalvzer is put into operation for the first time Assign the tests after method definition and reagent positioning Vou can change method assignments and program new controls later Only the name and batch number of the control has to be entered A total of 15 controls can be set with a maximum of 3 controls per test 5 2 1 Start PROGRAM CONTROLS 1 From the MAIN MENU select F5 SPECIAL FUNCTIONS F3 PROGRAM 2 Select CONTROLS 5 2 2 PROGRAM CONTROL Parameters Name The name of the control as provided on the insert sheet Enter the name here if you are programming a new control Batch number The batch number as provided in the insert sheet Enter the batch number here if you are programming a new control 5 23 Program Controls Display Fields The analyzer displays the programmed tests that can be assigned to the CONTROL NAME displayed on the left You can scroll using the PAGE UP and PAGE DOWN keys or the ScROLLBAR All values set to the test are displayed the target value the low limit the high limit and information whether Westgard rules apply to control results To enter or change values do as follows 1 Selecta test from the list that will use the selected control r sas m 2 Place the curser over the test g Ed cem Control Test Control 3 Press the ENTER key 4 The values from the CONTROL PROGRAMMING screen are displayed Note With cut off tests only the set value
117. nalyzer automatically a new Reagent Installation is sent to the host so the host knows which tests can be requested e hereafter mentioned Physician name and limit flags are only used when the corresponding settings in the Installation Communication Host Communication menu of the analyzer program are 8 2 VITAL SCIENTIFIC N V VITALAB Appendix Message Result Direction analyzer host Format STx R device id 4 type 1 Sample nr 12 Sample name 20 date of birth 11 sex 1 Physician name 20 nr of tests 2 test_name 4 result 7 flags 22 limit_flags 3 units 6 ETX CR LF Explanation This message is sent automatically by the analyzer if the tests of a sample are completed or if the operator presses Ctrl F1 in the Evaluate Samples menu in which case a result message is sent for the sample currently displayed on screen If in the Communications menu Extended result is set to yes the extended result message is sent instead of the result message type 1 N Normal E Stat P Pediatric C Control S Calibrator B Blank FOR CONTROL Sample nr 12 Sample 20 date_of_birth 11 1 Physician name 20 is replaced by Contr_name 15 Batch_nr 10 FOR CALIBRATOR Sample nr 12 Sample name 20 date_of_birth 11 1 Physician name 20 is replaced by Calib name 15 FOR BLANK Sample
118. nalyzer offers an automatic re run facility The re run facility includes automatic sample reduction for high results The results are printed patient oriented and in the analysis sequence The print is held when a test is in evaluation or re run This prevents mixing up the analysis sequence The operator can change the format of the result report Prints of calibration curves reaction curves Levey Jennings plots test methods etc are possible 2 4 VITAL SCIENTIFIC N V VITALAB Introduction 2 3 2 Sample rotor The positions in the sample rotor Blank Calibrators Samples can also be used for controls en calibrators Pediatrics in case of the optional ISE unit one position is in use for the ISE activator Emergencies Controls Wash solution G O All positions can contain primary tubes and Terumo 5 tubes Also adapters for low volume containers are supplied An optional rotor for Kabe or Sarstedt 5 ml sample tubes is available The sample rotor is covered Sample pipette mechanism The sample probe equipped with a level detector aspirates any volume between 1ul and 30 ul in steps of 0 1 ul The probe dispenses it into the cuvette rotor and also mixes the reaction mixture Before sensing the sample the sample probe will take up an air bubble first The probe is washed in and outside afterwards 2 3 3 Reagent rotor f Note optimum cooling and to avoid of energy cover unused
119. ndo Propeties Views Pan C3 C Program Files Analyser Standard E 13 Calibitr dat 3 Qualctil dat 3 Reagents dat 378KB Disk free space 3 9168 5 My Computer 7 6 VITAL SCIENTIFIC N V VITALAB Installation 7 3 Configure software After the Analvzer program is started the program is readv to communicate with the Analvzer the Printer s and the Host Onlv change the settings of the so called Handlers with the Analvzer in the stand bv mode 7 3 1 Configure Analyzer Printer Handler Configure the settings of Printer 1 and or Printer 2 The default settings are Parameter Value lt Analyser Printer Handler ipi xi Number of jobs to print on printer 1 boc Nurnber of jobs to print on printer 2 p Exit Print to screen Off I SADC Selected printer Default Windows printer e eee Font Courier New 10 pt Em Font Pictures multiplving factor Right Picture multi Horizontal 3 Crone Nate Couier Now N zl plying factor vertical 3 Send to printer Paper Margins Left 1 Right 1 Function Description e Ecxit Quits the program e Shows the data in the screen preview screen Data is not send to printer e Select To select anv printer available in Windows e Send to Print the data printer 7 3 2 Configure Analyzer Communication Handler Configure the communication port between the PC and the Analyzer The other parameters are fixed The default setting
120. nput not used function depending on the COM port settings General remarks The analyzer PC uses a proprietary communication protocol to connect it to a host computer This is a normal RS232 serial interface protocol and the main properties are given here e Theanalvzer PC uses handshaking according to the settings of the COM port used for the communication with the host e settings of the COM port baud rate start stop and parity bits can only be programmed in the Analyzer Host Communication Program e Start and stop indicators of requests and responses respectively STX and ETX are used e No use is made of a checksum e There is no initialization of a complete communication protocol as such The host can simply send requests for reagent positions tests software versions etc The analyzer PC will respond with the corresponding answer In order to check the communication the Echo request function can be used e The analyzer works in the so called Upload mode This means that the host sends for each individual sample a Request Sample to the analyzer PC which directly responds with a Request sample indication and after finishing the request with a Result e n case the analyzer works with more than one reagent rotor the host must send only test requests for the tests actually installed on the reagent rotor The other tests for this sample can then be requested later e When the operator changes the reagent rotor of the a
121. nr 12 Sample name 20 date of birth 11 sex 1 Physician name 20 is replaced by Blank 5 The line test name 4 result 7 flags 22 units 6 is repeated for each test flags 22 see Extended result limit flags 3 see Extended result VITAL SCIENTIFIC N V 8 3 Appendix VITALAB O wa Message Extended Result Direction analvzer host Format STX X device id 4 tvpe 1 Sample nr 12 Sample 20 date_of_birth 11 sex 1 Physician name 20 nr of tests 2 test name 4 result 7 flags 22 limit flags 3 units 6 reag abs 7 raw result 7 raw units 6 detailed info ETX CR LF Explanation type 1 N Normal E Stat P Pediatric C Control S Calibrator B Blank FOR CONTROL Sample nr 12 Sample name 20 date of birth 11 sex 1 Physician name 20 is replaced by Contr name 15 Batch nr 10 FOR CALIBRATOR Sample nr 12 Sample name 20 date of birth 11 sex 1 Physician name 20 is replaced by Calib name 15 FOR BLANK Sample nr 12 Sample name 20 date of birth 11 sex 1 Physician name 20 is replaced by Blank 5 The lines test name 4 result 7 flags 22 limit flags 3 units 6 reag abs 7 raw result 7 raw units 6 detailed info are repeated for each test FOR ISE TESTS reag abs 7 is replaced by For sample blank tests the test name 4 is upper lowercase toggled flags 22 limit flags 3
122. nt bichromatic before reagent 2 addition e Endpoint bichromatic 4 5 minutes or 11 5 minutes after sample addition or 6 5 minutes after R2 addition e Kinetic 1 kinetic 2 and kinetic 1 2 can contain a minimum measuring time or two points for two point measurements In the mono mode e Reagent absorbance bichromatic before sample addition e Kinetic during 7 minutes after sample addition e End point bichromatic 11 5 minutes after sample addition e Kinetic can contain two points for two point measurements The different reagents are placed in a cooled reagent rotor A pipette injects the reagents directly into the reaction cuvettes The cuvettes are incubated at 37 C measured at the selected wavelength and washed for re use Bichromatic measurements are possible for endpoint chemistries The cycle time in the mono reagent mode is 20 seconds in which the analyzer can do up to 180 tests hour with the optional ISE unit 270 tests hour The cycle time in the dual reagent mode is 27 seconds in which the analyzer can do up to 133 tests hour with the optional ISE unit 222 tests hour Emergency and pediatric samples can be tested without interference of the routine workload The Vitalab analyzer is microprocessor controlled All mechanical functions are driven and checked by slave processors The operator has a constant view on the hardware status and performance of the chemistries When errors or flagged results occur the Vitalab A
123. nt is only possible when the analyzer is in stand by mode If the analyzer is switched off you must start this measurement manually each day It is recommended to do this measurement before the daily routine After the measurement the analyzer prints a list with the following information e Blank date time e Blank results e Number of days left up to the calibration of the respective method e Number of days left up to the next needle rinse e Number of days left up to the next system cleaning If you do not do this measurement the analyzer can continue to run In case of an expired calibration the analyzer will use the last calibration data until a new calibration is executed Max cuvet blank SD maximum standard deviation tolerated by the analyzer a blank measurement of the cuvette rotor The recommended value is 0 0200 If this deviation is exceeded an error message is printed out together with the rotor blank results Needle rinse interval The interval in days at which you do a needle rinsing 0 No needle rinsing 1 The rinsing must be done each day 2 The number of days after which rinsing must be done It is recommended to enter 7 days and to perform the rinsing at the end of the working week Activate the Needle Rinse function in the ROTOR SYSTEM menu Print only perf tests Only available when using report set up Only prints the tests and the test results if you request the tests in the request sample menu
124. nusual incidents occur VITAL SCIENTIFIC N V 4 13 Basic Routine VITALAB Print a load list Press F1 LOAD LIST to obtain a printout of the loading list Unload the samples 1 Remove the sample tube from the rotor 2 Press F4 CONFIRM UNLOAD to confirm that the sample was unloaded 3 After unloading a sample vou can immediatelv load a new sample at that position on the sample rotor If you press F3 CONFIRM LOAD the new sample is integrated into the current run and will be processed Processing Stat and Pediatric Samples Stat samples E1 E3 and pediatric samples P1 P5 are processed with prioritv The same applies to reagent blank and calibrator measurements as far as Stat Samples are concerned 4 14 VITAL SCIENTIFIC N V VITALAB Basic Routine 43 Checking and validating results 4 3 1 Evaluate Samples menu The incoming results of each sample and test DUAL Req Aray bulfer0 5 Reagent Disc ROUTINE Evaluate Samples 102318 A can be checked and if necessarv validated in the EVALUATE SAMPLES menu rus Date of bith 27 JUL 1974 Sex A printout of results is generated automatically if the parameter Automatic Evaluation was selected in the SYSTEM PARAMETERS menu lf you did not select this parameter only results M ou that have failed the test have to be manually validated Subsequent samples will not be printed until the previous samples have all been validated
125. of the control and confirm with ENTER 7 Type the batch number of the control in the Batch Number field The batch number can be found on the insert sheet of the control 8 Press ENTER to move to the test selection list 9 Select the test to be assigned using the CURSOR keys or the mouse 10 Press ENTER or double click on it to assign it to the control 11 Enter the Target value the Low Limit and High Limit and select Westgard active if necessary 12 Press F10 RETURN to return to the test list 13 To assign other tests to the control place the cursor on the test name and press ENTER or double click Repeat these steps Note amp Edit Control Delete Test Delete Retum Control Target values and limits must be entered according to the values given on the insert sheet The right hand side of the screen should now look like the display shown in our example 5 2 5 Assign a control to a cut off test 1 Select the Cut off test and press ENTER 2 Choose between positive and negative values 1 Select Positive if the result of the control has to be positive A negative test result is marked with a flag 2 Select Negative if the result of the control has to be negative A positive result is marked with a flag 3 Place the cursor either on positive or negative 4 Press F10 RETURN to return to the test list The selected function is displayed next to the test 5 2 6 Delete the assignment between
126. or Number The number of standards 1 9 for this calibrator Cut off When the number of standards is 1 the cut off option appears When you select the cut off option the test result will be in qualitative form To select cut off check the check box Function Keys SHIFT F3 DELETE CALIBR Delete the current calibrator from the list of calibrators F10 RETURN Return to the PROGRAMMING menu VITAL SCIENTIFIC N V 5 9 Extended Routine VITALAB 5 4 Programming Test Parameters All entries for each method are recorded in the TEST PRoGRAMMING menu The analyzer can give correct results only if the correct test parameters from the method sheets are entered The analyzer is delivered with a set of common parameters Please contact your reagent supplier to confirm that these parameters are applicable for their reagents To modify a test or to add a new test use the TEST PROGRAMMING menu and the parameters given in the method sheets The PROGRAM TEST screen consists of three pages Page 1 contains the global values that are independent of the run mode These values must be set to the values given in the respective method sheet Page 2 is for values that are required for Dual Mode Page 3 is for values that are required for single reagent use or Mono Mode Complete the pages as required for either dual or mono mode applications Parameters values are saved to hard disk Changes to the values will overwrite existing values without confirmation The
127. orbance limits are exceeded or the substrate is depleted Incubation time Endpoint Measurement Mode If only R1 is used you can select between 11 5 min and 4 5 min R2 is also used the incubation time is fixed to 6 5 min The incubation time refers to the time from addition of the last reagent or sample to the endpoint measurement Slope Blank Kinetic and Two point measuring Modes If reagent 2 is used select whether to use a Slope Blank Press ENTER select Yes or No from the drop down list and press ENTER to confirm If Yes is selected the analyzer subtracts the slope calculated before R2 was added from the slope that was calculated after R2 was added The field Slope BI Delay is diplayed after selection of Yes Slope BI Delay Appears if Slope Blank was selected with Yes Press ENTER and select a time in seconds Press ENTER to confirm E g 50 is selected the analyzer will use all the measurement points after 50 seconds measured after the sample was added for the calculation of the blank slope The calculated blank slope is subtracted from the reaction slope after addition of R2 when the results are calculated Point one two Twopoint Measuring Mode Enter the first value to select a delay to the start of the first measurement for a twopoint test This is necessary for incubation The second value has to be entered in the second drop down list to define last measuring point The longest possible delay is 236 sec in the DUAL
128. ormal volume Sample rerun volume R2 bottle 4 normal volume rerun volume Predilution 4 Delav min time VITAL SCIENTIFIC N V Extended Routine Press ENTER to show a drop down list of the available bottle sizes Select one size for reagent 1 bottle 5 25 or 50 ml Enter a reagent volume between 220 ul or with 2 110 ul and 399 ul Enter the volume in steps of 1 ul The total of the normal reagent volume R1 and R2 and normal sample volume may not be less than the cuvette s minimum volume 220 ul otherwise the entry in this field is automatically increased to a total volume of 220 ul The maximum volume is 400 ul The reagent volume for a rerun Enter a reagent volume between 220 yl or with R2 110 ul and 399 ul The analyzer needs this value to perform automatic rerun if necessary Enter the volume in steps of 1 ul The total of the normal reagent volume R1 and R2 and normal sample volume may not be less than the cuvette s minimum volume 220 ul otherwise the entry in this field is automatically increased to a total volume of 220 ul The maximum volume is 400 ul Enter the normal sample volume in 0 1 ul steps between 1 and 30 ul It is recommended to not enter a sample volume less than 3 ul Enter the sample rerun volume in 0 1 ul steps between 1 and 30 ul The analyzer needs this value to perform an automatic rerun if necessary It is recommended to not enter a sample rerun volume less than 2
129. owever the system automatically interrupts the procedure if the needles are touched Always keep rotors covered with the supplied caps except when loading or unloading Covering protects sample material and reagents from contamination Lamp ATTENTION Warning During operation the photometric lamp becomes extremely hot DO NOT look directly into the light path of the lamp when it is on DO NOT touch the lamp when it is on If the lamp needs to be changed wait until the lamp has cooled down For details refer to the chapter 6 Maintenance Troubleshooting and Error Messages in this manual Chemical hazards The operator is responsible for taking all necessary precautions against hazards associated with the use of clinical laboratory chemicals Specific recommendations for each reagent used with the analyzer are normally found on the manufacturer s package inserts or on product information sheets for each chemical Wipe up any reagent spillage on the instrument immediately Additional precautions Consult the reagent manufacturer for information on the concentrations of heavy metals and other toxic constituents in each reagent Avoid direct body contact with reagents Direct body contact may result in irritation or damage to your skin Refer to the manufacturer s reagent kit box and package inserts or product information sheets for specific instructions VITAL SCIENTIFIC N V VITALAB VITALAB Safety Precautions and Potential Ha
130. pe blank The points 7 to 11 marked with arrows were used for the calculation The column 12 21 shows the measurement points 12 to 21 that were used for calculating the test results The points 13 and 18 were used by the analyzer Point 13 was subtracted from point 18 and resulted in the delta absorbance shown above Results screen for a two point test with prozone check Standby The prozone effect can occur in tests that are based on the principle of the antigen antibody complex agglutination This effect often arises in patient samples with an extremely high antigen content The surplus of antigen inverts the reaction direction de agglutination and can cause incorrect or even wrong results To avoid this effect the analyzer offers a special check function for detecting prozone effects You can define the prozone check in the TEST PROGRAMMING menu 4 22 Stand by DUAL Req tray buffer0 5 Reagent Disc ROUTINE EvalSamples Graphic 70 10 32 AM 19AN 2001 build 09961 lain Menu Special Functions Rotor System ISE Installation Sample Number 123 448 Creatinine 293 7 nmol l Sample Name Charles Brighton Date of bith 31 MAY 1965 Sex Physician name Sample Type Normal IN PROCESS 5 READY REFER LIMIT ERROR 1 0 0 H 170 0 AST ASAT GOT Ca Calcium TBIL Total bilirubin TEIL in Special Functions Rotor System ISE Sample Number 123 448 Creatinine 293 7 n
131. positions during a test with caps The caps also prevent evaporation of the reagents The positions in the reagent rotor 24 bottles of 25 ml or up to 5 bottles of 50 ml a 50 ml bottle takes 2 positions of 25 ml bottles 8 bottles of 8 ml The reagent rotor compartment is cooled to approximately 12 below ambient temperature The rotor is covered to protect light sensitive reagents and to isolate from ambient temperature Reagent pipette mechanism The level detector in the reagent probe detects if sufficient reagent is present A heating element in the probe pre heats the cooled reagents Reagents must be prepared outside the analyzer After the probe transferred the aspirated volume of reagent into the cuvette rotor the probe is washed in and outside After a 2 reagent is dispensed the reagent probe mixes the reaction mixture 2 3 4 Pipettes Two syringes a 1000 ul and a 100 ul are used in combination with a valve block to pipette reagents and samples The pipette mechanisms are water filled Reagents and samples are aspirated with air bubble separation VITAL SCIENTIFIC N V 2 5 Introduction VITALAB 2 3 5 Cuvette rotor Note n Replace the cuvette rotor when one of the eight wavelengths prints the message SD ERR after the rotor blank measurement The quality and reliability is not guaranteed when the cuvette rotor is not replaced The multi use cuvette rotor contains 48 cuvettes incubated at 37 C The path length i
132. programmed they are available to record test requests Profiles can be programmed and changed when needed in the PROFILES menu Profiles have to be set for Dual and Mono Mode separately The procedure is identical for both modes 5 7 1 Program PROFILES 1 Select from the MAIN MENU F5 SPECIAL FUNCTIONS F3 PROGRAM 2 Select either Profiles Dual Mode or Profiles Mono Mode The test profiles positions show 3 Press ENTER to change to the input screen 4 Selecta profile name or an open position 5 Change the name of the profile or program a new name 6 Select the tests necessary for the profile These tests can be changed later A maximum of 15 profiles can be programmed Re Load Samples gt Profiles DUAL MODE Profiles MONO MODE Calculated resuite Needle Incompatibiliy Incompatibility Each profile name may consist of up to 20 amp characters spes Kevs SHIFT F1 DELETE PROFILE Deletes the selected profile without confirmation F10 SPECIAL FUNCT Return to the SPECIAL FUNCTIONS menu TAB Change between the profiles list and the menu CURSOR KEVS Move within the list and select different profiles ENTER From the menu moves to the profiles list From a specific position in the profiles list change to the next screen with the list of tests Note While requesting patients you can also use the barcode reader with the tests request chart instead of a manual profile selection inine
133. r0 5 Reagent Disc ROUTINE EvalSamples Graphic 3 5853AM 18JAN 2001 buid0 33 fain Menu Special Functions Rotor System ISE Installation Sample Number 123 448 Phosphatas 385 Programming Sample Name Charles Brighton READY Date of bith 31 MAY 1965 Sex M Physician name Sample Type Normal IN PROCESS 5 AST ASAT GOT 1301 UA Ca 155 6347 lu INFO INFO CHeacivepro INFO Cocain NEGAT VITAL SCIENTIFIC N V VITALAB If you switch to the table mode with F2 the screen shows a table with the absorbances measured during the test The result of the calculation is a delta absorbance per minute shown at the top of the table The table also shows that eight measurement points were used for the calculation The measurement points used for calculation are the points 14 10 21 each of them marked with an arrow Basic Routine lain Menu Special Functions Rotor System ISE Installation Sample Number 123 448 Sample Name Charles Brighton Date of bith 31 MAY 1965 Sex M Physician name Sample Normal IN PROCESS 5 Phosphatas 385 Graphic Mode Table Mode ASAT GOT 1301 UA Calcium Total bilirubin Total bilirubin Phosphata Creatinine Glucose Results screen for a bichromatic endpoint test In the graphic mode the result of a bichromatic endpoint test run in the Dual Mode is shown Six points are shown marked on the x axis
134. raphic mode shows a graphic representation of the blank measurement results Rotor Needle Rinse D Blank Rotor aveo AAAA ISE Cuvet AV 0 3504 50 0 0059 Lamp AV 22780 50 0 0019 Last blank date 22JAN 2001 time 4 16 00 AM 1 Keys TAB or ENTER If in the menu move to the right side of the display ARROW KEYS Selected a wavelength F1 Print Print out the current display F2 Blank Start the cuvette blank measurement This is only possible when the system is in stand by mode thus not processing samples This takes about 13 minutes Enter OR F7 View a graphic representation of the measuring results Selecting F7 TABLE MODE or GRAPHIC MODE ENTER within the graphic mode changes to the table mode again F10 RETURN Return to the previous screen ROTOR SYSTEM menu F10 SPECIAL From the ROTOR SYSTEM menu return to the SPECIAL FUNCTIONS menu FUNCT VITAL SCIENTIFIC N V 6 17 Special functions VITALAB 6 4 4 Replacing the Photometer Lamp The photometer lamp has to be replaced after about 2 000 operating hours Indications for a necessary replacement of the lamp are unusual measured results that cannot be explained In all cases that unusual measuring results occur check the intensity of the lamp This is done via the FUNCTIONAL CHECK ADJUSTMENTS menu menu SERVICE Should the photometer lamp have any mechanical technical defects an error message is displayed on the screen
135. rator a control or a blank sample you can go directly to Sample Type Use the ARROW DOWN key or the mouse Request Number Sample Number Sample Name Date of birth Sex Phvsician name 4 2 A request number is automaticallv assigned to each sample that is requested The request number is shown on the top left The request number indicates the place of the sample in the request buffer An asterisk indicates a new request that is not saved vet Enter the sample number Twelve characters are available letters and numbers If the checkbox Sample no autom incr of the SYSTEM PARAMETERS menu was selected the analyzer automatically increases the number entered here by one for each following test request You can also record the sample number with the barcode on the request form If no number is entered for a patient sample the request will not be accepted Enter the patient name or any other form of identification for the sample Maximum length 20 characters Enter the date of birth of the patient if the evaluation of the tests is patient oriented The entry form depends on the definition in the SYSTEM PARAMETERS menu Select the sex of the patient Use the drop down list or press M Male F Female or P Pediatric The analyzer uses the specified sex to compare the results to the respective reference values in the TEST PROGRAMMING menu Select Pediatric for samples of children Pediatric is normally used for childr
136. reagent kit involved the test parameters for each test and each reagent supplier needs to be established by appropriate methods before the system is used for actual measurements of patient samples Vital Scientific N V assumes no responsibility for erroneous test results caused neither by the reagents and or calibrators nor for inadequate use and determination of test parameters 1 1 2 Operator Qualification The analyzer should only be used by qualified and trained personnel who have taken part in a special operator training course on the instrument For clinical tests the instrument should be used under the management of a doctor or clinical inspector 1 1 3 Service Technician Qualification To install maintain and repair the instrument a service technician has to be trained on the instrument by the manufacturer or their representative A service technician is also expected to be familiar with the normal operation of the instrument as described in the User s manual and the special operations as described in the Service manual 1 2 VITAL SCIENTIFIC N V VITALAB Safety Precautions and Potential Hazards a 1 2 N pP I Description of symbols Symbols on the instrument This symbol means that the labelled item is hot while the instrument is in use Don t touch the labelled item as you could be burnt Attention consult instructions for use This symbol appears on several parts of the analyzer and the spec
137. ress ENTER to confirm The analyzer will id Em ie dps ia return to the incompatibility overview The default setting is that the test B is incompatible with test A This setting is indicated by the colon behind the test A If test A is very contaminating and no other reagent should be picked up by the reagent needle after the reagent A test then HCI must be linked to test A 5 6 4 Define Linked tests In this example the test B must be processed after test A when possible 1 Select from the MAIN MENU F5 SPECIAL FUNCT F3 PROGRAM 2 Select Needle Incompatibility 3 Press ENTER to activate the Needle incompatibility overview Information on test definition is found in the method sheets for the reagents Place the cursor in the first column behind the test A Press ENTER to show a list of tests Select the test that must go after test A Press ENTER to confirm The analyzer will return to the incompatibility overview Select F5 LINK The colon changes to a link sign The analyzer will now process test B directly after a test A if possible gr 4 Note front of a test name column D in the incompatibility screen indicates that this test has a sample blank dummy reagent This dummy reagent can be selected by pressing F7 SELECT DUMMY instead of ENTER VITAL SCIENTIFIC N V 5 23 Extended Routine VITALAB 5 7 Profiles Several tests can be combined to form profiles or panels Once profiles are
138. rror 8 9 failed overrun error failed parity framing or break error For sample blank tests or uninstalled tests the test_name 4 is left blank 4 spaces 8 8 VITAL SCIENTIFIC N V VITALAB Appendix Command Get reagent test counters Direction host analvzer Format STX N ETX Response STX n device id 4 status 1 reagent test count 5 32 times ETX CR LF Explanation status 1 0 success 7 failed message length error 8 failed overrun error 9 failed paritv framing or break error For sample blank tests or uninstalled tests the reagent test count 5 is set to 1 Command Request sample ETX Direction host analvzer Format STX Q Sample nr 1 12 tvpe l Sample name 0 20 date of birth 0 11 sex 1 Physician name 0 20 request tests 1 32 Response STX q device id 4 status 1 Sample nr 12 type 1 Sample name 20 date of birth 11 sex 1 Physician name 20 request tests 32 ETX CR LF Explanation Sample nr 1 12 type 1 Sample name 0 20 date of birth 0 11 VITAL SCIENTIFIC N V May contain the characters 20H 7eH except 3bH but may not start with 20H space N Normal E Stat P Pediatric May contain the characters 20H 7eH but may not start with 20H space Must have the same format European or American as programmed in the System param
139. rror 8 failed overrun error 9 failed parity framing or break error sample info only present if status is O type 1 Sample name 20 date of birth 11 sex 1 Physician 20 8 10 VITAL SCIENTIFIC N V VITALAB Appendix Command Ask sample result Direction host analyzer Format STX R Sample nr 1 12 ETX CR LF Response STX r device id 4 status 1 Sample nr 12 sample info ETX CR LF Explanation status 1 0 success sample ready or unloaded 1 success sample loaded or still in process 2 failed sample number still in request buffer not yet loaded 3 failed sample number not found 7 failed message length error 8 failed overrun error 9 failed parity framing or break error sample info only present if status is 0 or 1 type 1 Sample 20 date_of_birth 11 1 Physician name 20 nr of tests 2 test name 4 result 7 flags 22 limit flags 3 6 type 1 N Normal E Stat P Pediatric The line test name 4 result 7 flags 22 limit flags 3 units 6 is repeated for each test If the result is not yet ready it is blank flags 22 see Extended result limit flags 3 see Extended result VITAL SCIENTIFIC N V 8 11 Appendix VITALAB Gw w wOhs O Y C a 8 12 VITAL SCIENTIFIC N V
140. s Refer to chapter 5 Position the reagents Refer to chapter 5 3 5 System Handling Basics VITALAB 3 2 2 Start the analyzer 1 Setthe main switch to ON located on the rear panel of the analyzer 2 Setthe PC to ON 3 Startthe analyzer software The main menu appears on the monitor When the analyzer remains on but is not active carrying out processes the analyzer goes to Stand by mode DUAL Req bufier0 0 Reagent Disc ROUTINE Main Menu 4 Set the SYSTEM PARAMETERS and the RUN MODE menus You must set these parameters before you can prepare the analyzer for the initial routine e g VITAL SCIENTIFIC programming of test parameters and controls 5 Fil the analyzer with system liquid Use the SPECIAL FUNCTIONS menu The analyzer is now ready for operation F5 F FB F9 CtileF10 L I ji i Note When the analvzer has been switched off after the last routine was finished you must start manual cuvette blank measurement when you switch on the analyzer again the next morning You can select this measurement in the SYSTEM PARAMETERS menu All data present in the analyzer are stored when the device is switched off 3 6 VITAL SCIENTIFIC N V VITALAB System Handling Basics 3 2 3 Set the System Parameters 1 Select F5 SPECIAL FUNCTIONS F2 INSTALLATION The SYSTEM PARAMETERS TE menu is shown esent Poston DUAL MODE 2 Enter the system param
141. s The recorded test requests are highlighted The checkbox is a marked 5 Place the reader on the field Quit to record the next sample Do not scan barcodes of the type Codabar 6 Continue to record the data of the next patient 4 1 4 Do test sequence in repeat mode Use the repeat mode if you must run a number of samples with the same test selections 1 Enter the historical data of a sample Press TAB to go to the shown tests Manually select a sequence of tests Press ENTER to mark the tests Press F4 REPEAT MODE Press F8 to clear the screen for the next request If you selected the parameter Sample no autom incr in the SYsTEM PARAMETERS menu the sample number will increase automatically If the first sample number was 001 the next number will be 002 If the last number is A z 99 the next number will be B a 00 ark wn 6 Press F4 again to stop the repeat mode A new request starts with a test list with no tests selected VITAL SCIENTIFIC N V 4 5 Basic Routine VITALAB IL 4 1 5 Request test profiles Use the profiles to request repeatedly the same set of tests for a sample You can define the profiles for the current run mode in the SPECIAL FUNCTIONS menu F5 Program the profiles in the PROFILES menu F3 1 Enter the sample number 2 Enter the historical data of the patient if required 3 Press F3 PROFILE to open a window with a list of profiles 4 Selectthe desired profile The test list for the current
142. s 6 8 mm and the minimum measuring volume is 220 ul The cuvette rotor special made for Vital Scientific is covered by a heated cover The rotor makes in the mono mode a complete revolution plus one extra step every 20 seconds In mono mode the analyzer can measure 22 kinetic points an endpoint and a reagent blank at any of the 8 available wavelengths during a revolution The rotor makes in the dual mode a complete revolution plus one extra step in 27 seconds In dual mode the analyzer can measure 21 kinetic points an endpoint and a reagent blank at any of the 8 available wavelengths during a revolution In both cases the value of the reagent blank is used for various checks and the measurement of the endpoint can be bichromatic The maximum incubation time after sample addition is 11 5 minutes in mono mode and 11 25 minutes in dual mode The first kinetic point in the mono mode can be measured after 12 seconds the last after 422 seconds In the dual mode the first kinetic point can be measured after 24 seconds the last after 519 seconds After the last measurement the rotor is washed and dried To avoid drying in of the rotor the reagent probe automatically fills the rotor with water 2 3 6 Washing unit The washing unit aspirates the reaction mixture after analysis and washes the cuvettes with 4 x 500 ul water The waste is disposed in a waste container Separated waste concentrated and diluted in two containers is available ex factory op
143. s are i Analyser Communication Handler V0 51 running BBE Parameter Value to file Port COM1 Fon pse Bits persecond 9600 Data bits 8 i Parity None Ton fant Stop bits 1 E Asci Flow control None bet Status Function Description fr Stop Start Starts or stops the mmm communication between p the PC and the Analyzer Stop the Pot communication to ener To change the port number Port Select the port number for the communication between Analyzer and PC xeu VITAL SCIENTIFIC N V 7 7 Installation VITALAB 7 3 3 Configure Host Communication Handler It is possible to start the Host Communication Handler manually from the windows START MENU by selecting PROGRAMS ANALYZER and HOST COMMUNICATION With the Host Communication Handler switched on the parameters can be changed The default settings are Parameter Value 21550 2 Log Port None Delete Filename Bits per second 9600 Data bits 8 s og on Parity None z Transmit buffer Receive buffer Stop bits 1 Flow control None Erromous messages received Function Description e Port Select a port 1 8 to switch on the communi cation Note also the parameter communication enabled must be activated in the INSTALLATION COMMUNICATION menu ofthe analyzer program m s 7 8 VITAL SCIENTIFIC N V VITALAB Installation 7 4 Backup procedure It
144. ssed are shown Stat samples controls etc are labeled with their respective letters If you did not select the parameter Automatic Evaluation in the SYSTEM PARAMETERS menu the samples which require manual validation of at least one test are listed first The left side shows the results of the currently selected sample Make a printout of the currently selected patient Delete all results that are currently shown If you selected Save before clear in the SYSTEM PARAMETERS menu the results will first be copied to hard disc Go to the BLANK CALIBRATION INFORMATION menu Cancel the currently requested samples any time during sample processing The test is cancelled and a corresponding message is shown and printed out The result is not calculated Note that as the instrument is in fact already busy with this sample it might still pick up reagent for it Load the results that are stored on hard disk A file list is shown The file list shows the date and time of storage and the file size Select a file with the arrow keys and press ENTER When evaluating results from disk only the final result is available not the reaction curve Go to the QUALITY CONTROL menu Show the results of the sample that are shown on the left side of the screen in graphic mode Press F7 again to go back to the normal mode Go to the REQUEST SAMPLES menu Go to the LOAD SAMPLES menu Further samples can be loaded here Go back to the MAIN MENU VITAL
145. st be programmed before you define the test parameters for the various tests You can change the parameters for a calibrator or add new calibrators later A total of 50 calibrators can be set The analyzer supports 3 calibration methods e linear calibration with 1 standard where a concentration of 0 shows no reaction e linear calibration with 2 standards non linear calibration with 3 to 9 standards All these methods will give quantitative results Where a qualitative result is required either positive or negative cut off calibration must be used With a cut off calibration you can also define a close to cut off or 5 3 1 Program a Calibrator 1 From the MAIN MENU select F5 SPECIAL pomi Talli ipecial Functions Rotor SystenvISE Installation 5 FUNCTIONS PROGRAM and select CALIBRATORS from the menu A list of programmed calibrators appears 2 Press TAB or ENTER to move the cursor to the list of calibrators 3 Selectthe name of a calibrator to be modified or an empty position for defining a new calibrator using the cursor keys or the mouse 4 Press ENTER or double click on the selected position to call up the PROGRAM CALIBRATOR screen Profiles MONO MODE Calculated results Needle Incompatibility Incompatibility 5 8 VITAL SCIENTIFIC N V VITALAB Extended Routine EES ee Parameters Calibrator Name The name of the Calibrat
146. t after the cuvette blank If the counter of the system has recorded more than 10 000 tests an error message is displayed on the screen You can reset the counter to zero and cancel the error message by pressing SHIFT F3 Ignoring this message may result in incorrect results 1 Remove all samples Check that the analyzer is in standby 2 Select Change Rotor in the ROTOR SYSTEM menu 3 Remove the rotor cover from the cuvette rotor 4 Select F1 LiFT WASHARM The system will lift the wash arm 5 Lift the mixer unit manually 6 Remove the rotor V Attention DUAL Aray bulfer0 0 Reagent Disc ROUTINE Change measurement di 20502 PM 22JAN 2001 6019 09961 Main Menu Special Functions gt Quality Control Evaluate Samples Request Samples Load Samples F2 Shift F3 F10 Lit Reset Reset Retum Washam Washam Counter Observe all common safety precautions e g wear gloves since this part of the system is potentially infectious Also make sure that no liquids leak into the analyzer system 7 Unpack a new rotor Do not to touch the sides of the rotor but hold it by its center hold 8 Place the new rotor while assuring that the four notches of the rotor fit in the slits of the rotor holder 9 Press the mixer unit down 10 Select F2 WASHARM to lower the wash arm 11 Place the cover 12 Answer the question displayed on the screen After selecting Yes t
147. t chart 1 Scan the required test on the barcode request chart with the barcode scanner 2 Record the next test 3 If the scanned sample barcode is not coded with the barcode type Codabar select the field Quit on the barcode request chart with the barcode reader The screen for the recording of the next sample is cleared 4 6 VITAL SCIENTIFIC N V VITALAB Basic Routine 4 1 7 Request a pediatric sample Children s samples are generally treated like normal samples There are some differences e Select Pediatric at the parameter Sex e Select Pediatric at the parameter Sample Type e Pipette the pediatric samples in the specified sample cups Use the supplied adapters Place the samples in the positions on the sample rotor marked with P1 to P5 Note Pediatric samples have increased danger of evaporation minimize this danger the analyzer processes the pediatric samples with priority directly after Stat samples 4 1 8 Request controls calibrators and blank determinations You must regularly run the controls and calibrations The frequency depends on the respective method legislative regulations of each country and the organization of your laboratory This also applies to the determination of reagent blank values The necessary requests are recorded with the REQUEST SAMPLES menu Request the controls 1 Select the parameter Sample Type 2 Select Control from the drop down list The parameters Control Name B
148. t computer will be identified by this code VITAL SCIENTIFIC N V VITALAB Special functions 62 Setupareport If a special result printer is to be used for result printouts the printout format has to be defined in the Report Set Up menu The layout of the reports can be individually defined You can define which information is to be printed out and also which iti j Stand by DUAL Reg tray buffer 0 0 Reagent Disc ROUTINE Setup 21453PM 22JAN 2001 buid 0 3561 ON LINE position it should have on the paper eee ena 1 Select MAIN MENU F5 SPECIAL FUNCTIONS F2 INSTALLATION REPORT SET UP 2 Press TAB or ENTER In the report set up it is possible to write text like you would do with a normal word processor but you can also add parameter fields with a variable content The words between the brackets lt and gt in the figure below are the parameter fields which will be replaced by the actual contents of the l i sh parameters at the time of printing 3 3 i al 3 Select F3 PLACE ELEMENT to define the test attributes e g abbreviations and units of measurement and position the field Otherwise the results of a test will not be included in the result report 4 Select F5 SELECT TEST to select the tests Note If a test is not positioned i e not displayed the layout the results are not printed out in the result report even if the test was requested and me
149. te 1 2 or 3 calibration This value will also define the number of reagent blank measurements if programmed Enter a value and confirm with ENTER Interval Enter the calibration interval in days 0 to 99 as shown in the method sheet This number is the period in days when the method has to be re calibrated The analyzer includes the remaining days to the next calibration on the list with the daily cuvette blank measurement results If O has been entered here the analyzer only prints the test name without a mark on the list above and does not check the calibration interval Note If the calibration interval has exceeded the analvzer will keep using the expired calibration factor or curve Concentration Enter the concentrations of the standards 1 to 9 standards These should have the same units as selected in screen page 1 Test Parameters Absorbance It is possible to fill in values copied from a previous calibration or another system It is not recommended to set these values manually The values will vary in time and between systems Results based on these values may be invalid The units here depend on the test kinetic twopoint or endpoint Absorbance Limits Enter the absorbance limit for each individual standard If a Low High measurement exceeds the specified limits the analyzer displays an error message calibration limits violated This is used to check if a standard has expired or if standards accidentally are e
150. tential Hazards VITALAB II 1 1 General Before you start installing and working with the analyzer you should read the safety precautions and regulations shown in this chapter Safety comes first The analyzer was designed and manufactured according to modern standards and with regard to international safety regulations All possible risks that were known at the time of manufacturing were taken into account and either eliminated or reduced Nevertheless some sources of danger cannot be eliminated Please note the following guidelines When operating the Vitalab analyzer all national or international guidelines and regulations must be observed as in the normal lab routine Power supply accessories cables plugs must be installed in such a way that sources of danger overheating of cables short circuit due to incorrect fuse ratings loose cables etc are eliminated The user should be aware that if the Vitalab analyzer is used in a manner not specified the manufacturer the protection provided by the equipment may be impaired 1 1 1 Disclaimer Vital Scientific does not recommend any specific reagent kit reagent supplier to LI used combination with this analyzing system This instrument is designed as system allowing for a wide range of clinical chemistry tests to be adapted to the system As results obtained from a clinical chemistry system may vary depending upon the specific characteristics of the
151. the SYSTEM PARAMETERS menu For this purpose the system has to be in stand by mode Use the BLANK ROTOR menu for a manual start of the analyzer In order to facilitate the work and to avoid interruption of the routine the received samples must be prepared according to the respective lab organization instructions VITAL SCIENTIFIC N V VITALAB Svstem Handling Basics 3 2 8 Checklist for Routine Operation You can use the following list to check whether all prerequisites for operation of the Vitalab analyzer and the optional ISE unit are fulfilled 7 Are all cables correctly connected to the Voltage cables tubing to cooling unit System communication cables etc V Is the system switched Analyzer unit computer and cooling unit all switches Are all necessary parameters defined Run mode language print output type and host connection if applicable 7 Isthe liquid system filled with system liquid Were all work helps set as required Increase of sample number automatic rerun automatic result evaluation automatic cuvette rotor blank profiles V Were all necessary test parameters Photometry programmed 7 Areall reagents correctly positioned Reagent rotor Were all required calibrators defined Were all required test controls defined Were the incompatible tests defined 7 Has the cuvette rotor blank b
152. tion only The washing unit is equipped with liquid sensors to avoid flooding the system with water 2 6 VITAL SCIENTIFIC N V VITALAB Introduction 2 4 Computer control Note Only run the software in order to operate the analvzer The use of other software might cause failure in the communication between the analyzer and the computer An external computer provides the user interface to the analyzer The software is Windows based to save a maximum of time A keyboard or a barcode reader is necessary to enter data The test results are saved on the computer The software provides a standard way of output on a printer but the operator can change the format of the result report Test parameters control results and calibration results are also saved on the computer and ready for access any time is possible to connect the analyzer to a lab data processing system central processor host computer If so it is possible to enter test requests directly from the host computer Also the test results can be transferred to the host computer VITAL SCIENTIFIC N V 2 7 Introduction VITALAB 2 5 Cooling unit The analyzer is equipped with an external cooling unit The cooling unit provides a constant temperature of the reagents located on the rotor keeping them fresh as required by the application prescription When an acoustic signal is heard the cooling liquid must be refilled The control display shows the temperature of the cooling l
153. ts with no clearly definable cause like dirt reagents other liquids or the photometer e Air bubbles in the syringes and water leaking along the syringe plunger 1 Dismount the syringes 1 Inthe standby inactive or halted state select MAIN Menu F5 SPECIAL FUNC F1 ROTOR SYSTEM CHANGE SYRINGES and press ENTER 2 Select F1 LOWER SYRINGE to bring both syringes to their low position 3 Remove the screws of the drive pins through the plunger 4 Carefully unscrew the syringe from the valve and push it down a little then remove it from the instrument Now a new Teflon tip or a complete new syringe must be mounted If the last Teflon tip only lasted for TST a short period of time it is likely that the syringe itself is worn and must be replaced completely 2 Replace the Teflon tips 1 Pull the plunger out of the glass barrel 2 Remove the old tip from the plunger The small tip sample syringe can easily be removed with the finger nail The large tip reagent syringe can be removed with a scalpel 3 Outthe tip from top to bottom and remove it If the O ring under the tip is damaged replace it as well 4 Place the new tip upside down in the tip holder from the accessory box 5 Hold the plunger with O ring vertical and press the top into the Teflon tip 6 Mount the new or renewed syringes 1 Fill the glass barrel with water 7 There should be no air bubbles on top of the plunger now
154. u moves to the position list All results are deleted from the main memory Move within the list select a reagent position Change to the list of programmed tests Print out a list of reagents and their respective positions on the reagent rotor Deletes the selected reagent from the respective position Remove the reagent from the rotor Return to the previous menu Assigns the selected test to the current position This applies to both modes MONO and DUAL for reagent 1 Assign Reagent 2 of the selected test to the current position This only applies to the DUAL MODE A superscript 2 is displayed between position number and test name in the previous screen Assigns a dummy reagent reagent blank to the current position This only applies to tests with reagent blanks defined The superscript D in front of the test name is displayed in the previous screen to indicate the dummy reagent Assign dummy reagent 2 to the current position The columns contain a graphic representation that indicates whether the reagents exist and are installed empty reagent not defined in test parameters for this test reagent not installed e reagent installed In the MODE no reagent 2 can be installed VITAL SCIENTIFIC N V VITALAB Extended Routine 5 9 Calculated Results Use a formula to derive a calculated result from other test results The formula is set in the LOL HDL ratio CALCULATED RESULTS menu chee Up
155. u Yan 1 7 1 5 7 Analytical Q 1 7 eee ee ee ee ooo ooo 2 1 2 1 Intended USE eei tat Gee teret eee a a aa qasusqa 2 2 2 2 System presentation 2 3 20 JAMES o am timc em a asap 2 4 2 3 1 Sample rre hann nnne nnn nenne 2 5 2 3 2 Reagent iii V 2 5 2 3 3 Pipettes uu u ul u uuu umasa asa Ent Ent tt 2 5 2 3 4 Cuvette rotor nenne trennen nnn 2 6 Washing UN ecc c 2 6 24 Computer control 2 7 29 Cooling UNdino ita 2 8 VITAL SCIENTIFIC N V VITALAB 2 6 Barcode reader a 2 9 2 7 Operation requirements 2 10 28 Move the analyzer 2 11 2 9 Performance and technical data nn eee nn nn 2 12 2 9 1 Analyzer Technical Data ieu g ent a da 2 14 3 System Handling Basics a 3 1 3 1 Work Preparation 3 2 3 1 1 Manual Use 3 2 3 1 2 Menu structure any pasayan Usaha 3 3 3 1 3 Parts of the screen u
156. ul The analyzer corrects the rerun results according to the reduced sample ratio As for R1 a choice can be made between 3 bottle sizes 5 25 and 50 ml Note A bottle size must always be selected If a reagent is not used select a bottle size and enter 0 ul for the normal and the rerun volume Enter a volume between 0 and 180 ul Enter a rerun volume between 0 and 180 ul The sample can be pre diluted in the Dual Mode only Press ENTER in this field and select a pre dilution ratio 1 5 1 10 1 20 1 30 1 40 1 50 or No for no pre dilution from the drop down list E g a dilution ratio of 1 5 means 1 part of the sample diluted with 4 parts of diluent that results in 5 parts of solution Confirm with ENTER If you selected a ratio a field appears from which you have to select the diluent Press ENTER to open the list of diluents DIL 1 DIL 2 DIL 3 select one diluent from the list and press ENTER again to confirm your selection Note The selected diluent must be positioned in the REAGENT POSITION DUAL MODE menu A bottle with the diluent has to be placed in the corresponding position on the reagent rotor When predilution is used the instrument uses an extra cycle for preparation of the diluted sample In the first cuvette diluent is dispensed and sample is added and mixed In a second cuvette the reagent is dispensed The sample needle will pick up the diluted sample from the first cuvette and add it to the reagent
157. w sample Check the loaded reagents and their volumes in the REAGENT INFO menu Do this check before each run to make sure that there is sufficient reagent for all requests Check the results of the qualitv control Immediatelv check all incoming results of the current analvsis run and do validations if necessarv Go to the REQUEST SAMPLES menu Go back to the MAIN MENU VITAL SCIENTIFIC N V VITALAB Basic Routine 4 2 2 Load the sample rotor Place the samples on the rotor Use the positions that are defined in the LoAD SAMPLES menu F9 The analyzer shows the requests for controls and normal samples on the right hand side of the screen The requests are shown in the sequence in which they were entered in the REQUEST SAMPLES menu The special sample types are shown at the top of the list You can identify these samples by the correspon ding letter e B Blank 1 position e S Standard 9 positions e Control 4 positions e E Emergency 3 positions e P Pediatric 5 positions Load a blank measurement Load a blank measurement before you load the calibrator 1 Select the blank in the screen The small b changes to a capital B 2 Place the sample tube with distilled water or saline solution on position B of the inner rotor ring 3 Select the calibrator The small s changes to a capital S1 Place the sample tube with the calibrator on position S1 of the inner rotor Load a patient sample 1 Select the patient or t
158. xchanged If the same value is entered in both fields e g 0 000 the calibration limits will not be checked SHIFT F1 NO CALIBRATOR Deletes the assignment of the current calibrator to the test You may select a different calibrator in the TEST PARAMETERS screen VITAL SCIENTIFIC N V 5 19 Extended Routine VITALAB Ew V C o a Slope Intercept Only available if a TwoPoint calibration is required These values represent the slope and the offset of the calibration line for a 2 point calibrator The analyzer will automatically set the values in this column after calibration The absorbance value can also be filled in by the user but this is not recommended 5 5 2 Cut off tests If a calibrator has been programmed as a cut off calibrator one point calibration then any test that uses this calibrator is a cut off test In the PROGRAM CALIBRATOR screen the fields Cut off and Flag will be displayed The result for a cut off test is the measured absorbance value delta absorbance or delta absorbance per minute depending on the type of test and gives a Positive or Negative result To select Cut Off 1 Press ENTER and select Increase increasing STANDARD Pogam Cali TEMA ZOO curve or Decrease decreasing curve from the drop down list Press ENTER to confirm 1 If the measured delta absorbance is Absorbance limits higher than the delta absorbance measurement of the standard then 5
159. y modes are possible for each position 0 6 The position can be loaded The sample has been processed You can remove the sample from the sample rotor Darkened position The analyzer is currently processing the sample B This position is used for the reagent blank value measurement Always place the sample tube filled with distilled water or saline solution in this position 1 9 These positions are used for calibrator standards If more positions are needed you can use any position for normal samples 1 51 P1 P5 These positions are primarily used for pediatric samples The analyzer processes these samples first except for Stat samples E1 E3 These positions are used for Stat samples These emergency samples are processed first C1 C4 These positions are used for the controls With the analyzer you can use four controls for each batch If more positions are needed you can use any position for normal samples 1 51 This position is used for the washing solution each analysis run the washing position must contain a sample tube filled with a sufficient amount of washing solution Recommendation use 10 Sputofluol solution as washing solution After the last measurement of a batch the analyzer automatically starts to pipette for cleaning the tubes and the valves For cleaning you must install HCI in the reagent rotor and a washing solution on the sample rotor The cleaning consumes 6 times 400 ul
160. y original spare parts should be used in the maintenance of this analyzer Only original disposables and accessories should be used in the operation of this analyzer 1 4 8 Instrument Unused for a Long Time If the instrument will not be used for a long period of time contact Technical Support for further information 1 6 VITAL SCIENTIFIC N V VITALAB Safety Precautions and Potential Hazards a 1 5 Use of materials with the analyzer 1 5 1 Specimens This analyzer is designed for measurements of analytes in samples of serum plasma urine and CSF Patient samples should be prepared and handled in accordance with the instructions from the reagent manufacturer Refer to the reagent kit insert for detailed instructions 1 5 2 Warning Make sure that the sample reagent mixture does not contain any blood clots dust or other insoluble contaminants If insoluble contaminants are contained in the sample correct measuring values may not be obtained 1 5 3 Reagents and calibrators Vital Scientific N V does not recommend the use of specific reagents or calibrators in combinations with this analyzer Several reagent manufacturers have application sheets available for a large variety of clinical chemistry tests Therefore contact your local reagent supplier for the application sheets required 1 5 4 Warning uU ATTENTION Warning Treat all reagents according the manufacturer s recommendations Refer to the reagent kit box and package
161. yed For each alternative a key or key combination has to be pressed The analyzer displays the respective keys and their function on the monitor Keys F1 Check Repeats the procedure that led to the error message if the importance of the Again message is unclear Take action if the message is displayed again F2 Confirm This key is only available if a message is displayed for insufficient amounts of refill reagent In this case replace or refill the reagent bottle on the reagent rotor and then press F2 The error message will be cleared from the screen F4 Acknow Acknow Message This key is only available if the message displayed on screen message requires no immediate action F5 Reset Partly resets the analyzer This key is only available if the message is related to a specific component of the analyzer The reset is carried out for the respective displayed component If the measure is successful the analyzer continues Press SHIFT F6 if pressing F5 was not successful system does not work SHIFT F6 Resets the analyzer Only use SHIFT F6 if the message cannot be cleared from the System reset screen using the other keys Inform the service technician if the message is displayed again after a reset SHIFT F7 The analyzer status remains inactive The analyzer cannot continue with the Remain operation It can only be brought back to the stand by mode by triggering reset inactive Inform the service technician ALT F10 Halted The analyz
162. ysician name Dr Livingston Sample Type Normal READY When the processing of a sample with all its requested tests is ready the analyzer automatically prints out the results and sends the results to the Host through the LIS if the analyzer is ON LINE The printout includes the sample number patient name date of birth sex sample type sample status and the tests that are done for that sample The test results are shown with their respective units mg dl mmol l etc If the parameter Automatic Evaluation in the SYSTEM PARAMETERS menu was not selected and one of the tests exceeds or falls below the limits that were defined in the test parameters TEST PARAMETERS menu the patient result will not be printed out until a manual validation of the measuring results has been done The result will also not be printed if error messages such as Insufficient Sample were shown VITAL SCIENTIFIC N V 4 23 Basic Routine VITALAB 4 3 4 Validation of a Result In the LOAD SAMPLES menu or MAIN MENU press Gss erri F7 to go to the EVALUATE SAMPLES menu In this i menu you can check and if necessary validate results of a sample that is currently being isse processed Sample Type Normal READY 1 SMT Cabra rator Digoxine Calibr Digor Sample Number 123 444 Sample Name John Brown Date of bith 27JUL 1974 M AST ASAT GOT uA CHOL cholesterol 216 mmol UREA Urea 66 mmol GGT GGT 48 U
163. yzer flags the result An automatic rerun of the test starts if the Automatic Rerun option was selected in SYSTEM PARAMETERS 5 17 Extended Routine L A R Abs L Limit R Abs H Limit 1j R Abs Deviation Substrate depletion 5 18 VITALAB The reagent absorbance low limit that is given in the method sheet It is used to check the reagent absorbance before the sample is added If the measured absorbance value of the first reagent is below this limit the analyzer flags the result The reagent absorbance high limit that is given in the method sheet It is used to check the reagent absorbance before the sample is added If the measured absorbance value of the first reagent is above this limit the analyzer flags the result Note If the respective low and high limits are identical no check will be performed by the system This field is displayed if 0 was entered for the R2 bottle in the field normal volume The value is only used for decreasing reactions Here the maximum deviation of the calculated extrapolated reagent absorbance value from the measured reagent absorbance value point measured before the sample is added is entered The set value ensures detection of substrate depletion If the extrapolated reagent absorbance falls below the measured reagent absorbance minus the programmed reagent absorbance deviation the result is marked with an error flag If the reaction increases it is recommended to ent
164. zards OLGA Avoid direct bodv contact with cleaning solutions Direct bodv contact mav result in skin irritation or damage Refer to the manufacturers kit box and package inserts or product information sheets for specific instructions 1 3 6 Biohazard V ATTENTION Warning Controls patient samples and liquid waste are potentially infectious The handling of patient samples control sera and liquid waste must be performed according to national and international laboratory safety regulations Specimens patient samples and controls and liquid waste should be considered potentially infectious and capable of transmitting human immunodeficiencv virus HIV hepatitis B virus HBV and other blood borne pathogens The handling of these substances must be performed in accordance with established laboratory safety regulations in order to minimise risk to laboratory staff This includes wearing of gloves splash protection etc Contact of skin and mucous membranes must be avoided This also applies to all components of the instrument that are exposed to these substances If any specimen is spilt on the instrument wipe it up immediately and clean the contaminated surface with a disinfectant In various countries there are regulations on the disposal of waste Refer to local sources for additional information on correct waste disposal VITAL SCIENTIFIC N V 1 5 Safety Precautions and Potential Hazards VITALAB Ew s sl C 1 4 Installation and

VITAL SCIENTIFIC N.V. - Frank`s Hospital Workshop

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