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User Manual - Frank`s Hospital Workshop

1. START SESSION SELECT PROFILE Par 321 SELECT PROFILE x SET CALIBRATION gt forQleritative assays PARAMETERS lt SER lt en Per 52 2 page 1 4 SAMPLE SAMPLE SETTING y PATIENT CARD SETTING lt Par 5 2 3 x RUN ANALYSIS cm 1 Microplate n 2 Common reagents 4 w lt 3 a Specific reagents for assay 1 WORK AREA ee 3 b Specific reagents for assay PREPARATION ml Per 532 4 Samplesera 5 Dilution cups Prime Start analysis NO YES Tank level ANALYSIS Prine execution EXECUTION Time flow for every operation Par 53 3 ae EXECUTION Session end remainingtime Le Errors in process liquid not found D D gt x A couple of windows A 5 y A 4 CONTROLS AA BB CC etc STANDARDVALUES gt a am a nex previous presan CALIBRATION CURVE for quantitative analysis oriy a Ce Or TSR REJECT STORE RESULTS REJECT RESULTS L Go tothe next assay NO zu gt YES 0 LAB PRINT 2 y 01 PATIENT 01 REPORT PATENT REFORT nex lt gt PRINT Cx yv Go back tothe MAIN MENU Par 5 1 x gt PATIENT DATABASE to locate microplates into their oan tolocate reagents on the common tolocate controls and cdibrators assay tolocate controls and calibrators assay tolocate the samples into the tolocate the predilution Don t forget locate the wesh
2. Stop solution s Selecting this item the machine will execute the dispensa Oh 12 32 tion of the Stop solution in accordance to the selected assay settings Note1 In phases 1 2 3 the machine does not consider the incubation times programmed for that assay For this reason the operator shell apply directly the necessary incubation time for each using a stop watch or a timer Note2 The timer indicated for each phase is the expected duration of that phase User Manual ELISYS 2 PLUS 27 74 Session setup Sell increase a fa iD z F z Patient card AFP Code 4 TE Single steps 1 m T 7 Dispense 2 l fr Ackhwate microplate s Uh 1 168 i 2 I tl z 3 z 7 Wash Sag and control well Oh 0 0 Wash conjugate wells Oh d 21 i al T i 5 u gt he Kun ef F T i Run later IT dr em i Cancel smr Pen 10 ft E Usedwell 17 Full strips 324 BEEEENE za 17 to dispense sera Pressing this button the following menu appears Activate microplate s Selecting this item the machine will execute the Oh 0 0 activation of the microplate s respecting the pre W viously set time ash sample and control wells Selecting this item the machine will execute the Oh 15 24 first washing cycle respecting the previously set W time ash conjugate we
3. ELISYS 2 PLUS has the capability to work with racks of different type from the standard These racks called universal are capable to hold bottles of different size They are of two types Universal Reagent rack Fig 1 Universal Common rack Fig 2 The universal reagent rack is equipped with removable rings to better fit the smaller bottles size removable removable ring 28 ring O18 Fig 2 Universal Common rack 5 6 1 The disposition of standard racks on the working area is shown in Fig 3 the standard common rack is placed on the left side close to the sample rack The standard reagent racks up to 8 max are placed in the following positions from position 1 to position 8 Disposition on the Working Area Standard Racks FOG ORORO QIO OPOPO OP O O O OT 8701 1 8792 8762 8732 08 8 81 02 HKKP NO ON EN OT QI00 00 o0 o o o 010 o0 o o o M s 3 4 5 6 7 8 Sample rack Common Rack Reagents rack Standard Standard Fig 3 User Manual ELISYS 2 PLUS 51 74 5 6 2 Disposition on the Working Area Universal Racks To introduce the universal rack on the working area the following criteria are to followed see Fig 4 The universal common reagent has to he placed always on the right side of the working area to cover posi tion 7 and 8 The universal reagent racks are to
4. Run assays sequence 30 74 User Manual ELISYS 2 PLUS 5 3 1 Run the Process N Human From the Run button of the patient selection window during the setting of the session or from the RUN voice of the menu Session it is possible to start the execution of the working session 5 3 2 Work Area Preparation 5 3 2 1 Microplate Composition The first window shown is a summary of the set methods and an overview of the composition of the microplates It shows the strips used for each method and in which execution they are carried out Prior the test performance the strips always have to be filled up It must be guaranteed that all positions for each strip are occupied with wells Otherwise during the wash process water will spill inside the instrument These positions are marked as neutral wells 5 3 2 2 Common Reagents The next window shows the display of the common tray where the necessary dilutors wash solutions stop solution and substrate must be arranged for all the methods to be processed in the session Note Different trays can be used for method sets which require a different configuration 5 3 2 3 Specific Reagents for Assay A B The following windows show the arrangement of the reagents wash solution dilutors controls calibrators for each method foreseen in the session Assay A Microplate composition Teele ek ye ene 1 ee ee Ye dad E BOO OOO OOO UR 4D UO OOO ORDO E 0161610666
5. values for the samples controls and standards as well as any mis take if any To set up the printer Activates the single steps operation This command runs the working procedure if a session has been set up Activates the display of the results of a processed but not stored working session Exit from the program Displays the stored medical reports They can be accessed or by the pa tient s name and or the execution session date To display modify and insert the patients in the database To display modify and insert the sentences frequently used and associated to the notes in the report To display modify and insert the parameters for each method To set the heading to be printed on the lab printing reports To indicate the doctor s name on the analysis report To choose the serial port or simulation mode To insert or modify the password Enables the external incubation function To prime the needle To prime the washer To set the number of strips to be washed To set the number of strips to be emptied To set the reference temperature and to monitor it continuously To check the instrument s moving parts and show any bad functioning To display all the information concerning that software version To display the software interactive guide User Manual ELISYS 2 PLUS 21 74 9 2 WORK SESSION SETUP From the Session menu click on New to access the Profiles Selection window which shows the blank fields R
6. 5 4 4 1 WT Note 2 Remember the drawing of the Log logit curve re quires at least four calibration points but for the other types of curves only two of them are needed CURVE Calibration plot Point to point User Manual ELISYS 2 PLUS 41 74 CURVE Linear regression CURVE Log logit polynomial regression 42 74 User Manual ELISYS 2 PLUS N Human The Qualitative parameters button shows the parameter setting window for this type of analy i Control parameters Control check Cut Off parameters ae TO From this window for each method it is possible gt b fp i Names to Negcive il lt c fos insert the control names used by the method Posive il Cut Off a C1 b C2 c Names selecting them from the present ones ae ee in the list or writing them directly into the box ua A ou m Equivocal zone set the acceptance control condition Control check up to a maximum of four conditions C5 High 0 CE is Low Enable the predilution of controls Controls Prediluition 7 set the positivity condition That means that it has to be set if the sample absorbance has to be higher or lower than the one of the Cut off to consider the sample positive see note 1 set the cut off equivocal zone set the cut off absorbance calculation value Note 1 The Cut off is a threshold value of assorbance to be deter
7. ON PC 4 7 1 PC Minimum Requirements Microsoft Windows 95 or 98 15 MB free on hard disk 1 44 Mb floppy driver RAM 32 Mb Pentium or compatible processor at 166 MHz Display adapter standard VGA 640x480 Printer 4 7 2 Software Installation AP 2 is the program specifically developed for ELISYS 2 PLUS To install AP 2 program on the PC place ELISYS 2 PLUS CD in the CD ROM drive If the installation program does not start automatically proceed as follows Start Explorer from the Start menu and select the letter of the CD drive Start the Setup exe program by double clicking with the left key on the mouse The installation program is now initialised Follow the instructions shown on the screen The program is now installed and the ELISYS 2 PLUS icon is available on the desktop Double click on it to run the program MW Remark For Microsoft Windows 98 Il Edition you need the BDE Installer version 1 0 start BDE Installer also with Setup exe 18 74 User Manual ELISYS 2 PLUS N Human SECTION 5 5 OPERATING INSTRUCTIONS 5 1 INTRODUCTION The instrument requires the use of chemical reagents and other dangerous corrosive irritant and harmful CHEMICAL SUBSTANCES which can cause damages When this label is found be careful and pay attention to the producer recommendations The instrument requires to handle samples which can be infected urine and human serum In this condition INFECTIONS or C
8. Rubella IgG Rubella IgM Toxo IgG Toxo IgM Varicella IgG Varicella IgM Helicobacter IgG IgA Dengue IgG IgM Predilu1 ap2 dilution ratio 1 100 e SV1000 syringe suck up speed the sample dilution is carried out in two times the dispensation speed is SV3000 Sample1 ap2 dispensation volume 100 ul e SV500 syringe suck up speed the controls standards and samples dispensation is carried out in double mode with just one move the dispensation speed is SV2500 The blank wells are left empty Conjuga1 ap2 dispensation volume 100 ul e The conjugate dispensation is not carried out onto the Blank wells e The syringe suck up speed is SV1000 the Conjugate dispensation is carried out with just one move the suck up speed is SV3000 Chromoget ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Chromogen dispensation is carried out with just one move the dispensation speed is SV3000 Stop1 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Stop Solution dispensation is carried out with just one move the dispensation speed is SV2500 GROUP No 2 Used for HIV 1 2 Predilu2 ap2 e The group does not involve the sample predilution Sample2 ap2 dispenses 20 ul of sample 100 ul of dilution e The samples and controls or standards dilution solution is dispensed into the blank well with just one move The syringe suck up speed is SV500 the dispensation speed is SV3000 e Th
9. all information about the session results User Manual ELISYS 2 PLUS 71 74 DETAILLED SPECIFICATION OF THE INPUT FILE WLT Set up the input file as in the following format to make it understandable by the client p c lt Assays gt Progressive number Assay Name max 8 elements lt Samples gt Patient progressive Patient Code Progressive number of the first Assay Progressive number of the last Assay max 40 60 patients according to the selected sample tray PROCEDURE To import a work list use the following procedure From Select Profile by pushing Load work list button the following window will be shown 212 Cerca jin Sy ap22 s ff et FE Mome file Apri Tipo file ap2 worklist archive wilt Annulla Select Archive allows the user to select the WLT file Click button Open to accept If the file is correct the assays specified in the file will be shown in the window Select Profile If the assay names do not match the ones defined in the local archive of the client s PC an error message will be displayed Press OK in the Select Profile window to go to the sample selection window During this phase the software checks the compatibility of the selected assays an error message will be shown if in the same session something is not compatible The data coming from the WTL file are only accepted if they are compatibility to the sel
10. and by choosing the following values for the coefficients Example 5 NC ti trol The cut off is available ce a Cutoff Ne PC positive control Having 3 controls NC CO PC supposing to put the Cut off in C2 position choose the following values for the coefficients a 0 b 1 c 0 44 74 User Manual ELISYS 2 PLUS N Human 5 5 1 Working Parameters Predilution Prediluition Sample Conjugate Substrate A E Stop Read syringe speeds Hz Volumes hl Dispensing Washing Cycles Emm 1000 2 Aspiration Alr bubble 1000 E sample Aspiration Dead wol 500 10000 Predilution Dispensing Syringe speed for dispensation of the diluent sample Aspirating Syringe speed for diluent aspiration Aspiration Single Execution time for a single dispensation of sample Dead Vol Remaining volume inside the dilution bottles User Manual ELISYS 2 PLUS 45 74 Sample Prediluition Sample Conjugate substrate AB stop Read Mame syringe speeds Hz Execution time s single 23 Duplicate 24 Yolumes Ul Washing Cycles 1000 e H Air bubble mn Dead Control ol lt 00 Dispensing 3000 Aspiration 500 Duplicate sample disp mode ar 1 well attime On 2 wells attime Dispensing mode 15 Dispense diluent in the Dead Standard wol blank well eul m Dispense sample together withthe conjugate _ oo Execution time fo
11. be marked When these condition are fulfilled the software comes up with this message Answering yes gives the user the possibility to insert another test Human Elisys 2 FE 2 Do you want to perform other steps while incubation goes an 54 74 User Manual ELISYS 2 PLUS N Human After choosing an assay the software request to remove thep late from the system and put the new one to the Human Elisys 2 Ej Put microstrip platels in the owen Put the new microstrip plates in work position work position During processing the new assay the remaining time from the external located test is displayed 00 59 38 When the incubation time is over the software prompt to bring the plate back to the system in order to continue with the test procedure Human Elisys 2 E Put microstrip plate s back in the machine Make sure to have the right trapje in proper positions 5 7 3 Simulation Mode The demo mode allows a complete run to be performed in a dummy mode without the need to connect an in strument Among other things it can be used to demonstrate the software including the data reduction even without an instrument In order to activate the demo mode open in the menu 1 Settings 2 Serial port Serial port settings x Baud rate zii User Manual ELISYS 2 PLUS 55 74 5 7 4 92 Positions for Predilution A new segment for the predilution have been designed The new segment has enough space for
12. calculate the Cut off NC negative control f l l PC positive control according to the optical density values average of the negative and HC high positive control positive controls Considering that formula 1 can be written as following cut off NC 2 PC 2 comparing this formula with the general one provided by the in strument cut off a x C1 b x C2 c 2 it is possible to calculate the cut off value as required by the method assigning to the coefficients a b and c the following a 0 5 b 0 5 c 0 values The negative control has to be positioned in C1 position and the positive control in C2 position The high positive control may be positioned in any other position Example 2 cut off NC Kx PC K Factor In this case the instrument calculates the cut off as indicated by the method using the formula 2 and by choosing the following values for the coefficients The negative control has to be positioned in C1 position and the positive control in C2 position Example 3 cut off PC x K K Factor In this case the instrument calculates the cut off according to the method requirements using the formula 2 and by choosing the following values for the coefficients The positive control has to be positioned in C1 position Example 4 cut off K K constant In this case the instrument calculates the cut off according to the method requirements using the formula 2
13. eliminate any dirt or disinfectant solution 8 Carefully dry the instrument 9 Put the instrument and its accessories into their original box 10 Wash and disinfect the hands by using a light detergent 11 Fill in a Decontamination Declaration and enclose it with the instrument User Manual ELISYS 2 PLUS 63 74 DECONTAMINATION DECLARATION The Decontamination declaration as shown below has to be filled in and enclosed with the instrument before shipping it for a maintenance service The declaration has to be stuck on the instrument package DECONTAMINATION DECLARATION Instrument Model S N We declare that the instrument and its accessories never came in touch with dangerous biological sub stances the instrument and its accessories have been decontaminated to eliminate every bio logical substance which could be dangerous for personnel User Client name Address Country Responsible name Date Signature and Stamp 64 74 User Manual ELISYS 2 PLUS N Human APPENDIX B SPARE PARTS CONSUMABLES ACCESSORY PARTS A separate Spare Parts List is available in the Service Manual HUMAN Cat NO Description 7301 45 Predilution segment re usable i i 17301 58 Reagent rack Infectious Diseases 1 1 1 17301 46 nterferential filter 405nm 1 1 Fast Washing System User Manual User Manual ELISYS 2 PLUS 65 74 APPENDIX C ELISYS 2 PLUS RACK DESCRIPTION RACK 2 Deng
14. i e NAOH 1Mol Prime the needle and the washer unit At least 5 times with the decon solution When the decontamination process has finished it is very important to run multiple wash cycles for the needle and for the washer unit with distilled water The room and table where the instrument is placed have to be always clean remove any dirt Note When the instrument for cleaning or disinfecting purpose requires a washing cycle for manifold cleaning bottle T1 has to be substituted with an equivalent bottle con taining distilled water or decontaminating solution see Sect 4 4 for needle internal and external cleaning bottle T3 normally containing distilled wa ter has to be substituted with an equivalent bottle containing decontaminating solu tion see Sect 4 4 User Manual ELISYS 2 PLUS 59 74 6 4 GENERAL INSPECTIONS AND CHECKS It is advisable to check periodically all the instrument parts 6 5 REPLACE THE SYRINGE TIP The instrument can perform precision dispensation with up to 10 ul due to the 1 ml syringe located on the diluter The syringe tip status has always to be good in that it can be worn out by the continuous work we suggest re placing the tip every months To replace the tip operate as follows Open the SIM program Type the letters TM Press ENTER Press F9 Enter the command A and 1000 The syringe moves down until the end Turn the syringe anticlockwise until the glass b
15. ne h gt W o Y Warning to prevent instrument troubles during microplate washing sequence all the requested stips must be completed with the 8 wells 4 5 5 Wash Basin for the Needle In order to wash the external part of the dispensing needle it is dipped into the wash basin where the washing liquid continuously flows To wash the internal part of the needle the dispensation liquid is pumped into it To prevent samples contamination the needle washing system is automatically activated when necessary 4 5 6 Reader Washer Group The reader washer group is located on the top of the microplates area It allows to run automatically both the photometric reading and the microplates washing in Succession according to the program User Manual ELISYS 2 PLUS 17 74 4 6 ELISYS 2 PLUS PC CONNECTION The instrument is equipped with an RS232 serial port for PC connection A 9 pin connector is available on the instrument right side panel see fig 4 4 Generally two serial ports to choose from are located on the rear panel of a PC COM1 and COM2 a 9 pin male connector and or a 25 pin male connector A connection cable PC ELISYS 2 PLUS with two 9 pin connectors female male is supplied with the instru ment An adapter 9 25 pin may be necessary on the PC side connection G En 4 NARAON O AJ Fig 4 4 RS232 serial port located at the instrument right side 4 7 SOFTWARE INSTALLATION
16. not carried out e The suck up syringe speed is SV1000 the Conjugate dispensation is carried out with just one move the dispensation speed is SV3000 Chromoge3 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Chromogen dispensation is carried out with just one move the dispensation speed is SV3000 Stop2 ap2 dispensation volume 50 ul e The syringe suck up speed is SV1000 the Stop Solution dispensation is carried out with just one move the dispensation speed is SV2500 GROUP No 4 Used for Anti HCV Predilu4 ap2 dilution ratio 1 20 e Suck up speed of the SV1000 syringe the sample dilution is carried out in two times the dispensation speed is SV3000 Sample4 ap2 dispensation volume 100 ul e The controls or standards and samples are dispensed with just one move The syringe suck up speed is SV500 the dispensation speed is SV3000 The blank wells are left empty Conjuga4 ap2 dispensation volume 100 ul e The Conjugate dispensation is not carried out onto the blank wells e The syringe suck up speed is SV1000 the Conjugate dispensation is carried out with just one move the dispensation speed is SV3000 Chromoge4 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Chromogen dispensation is carried out with just one move The dispensation speed is SV3000 Stop4 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Stop Solution dispensation i
17. parameters Qualitative parameters Homones Vash ash butter 1 Group par 131 Notes Cancel 5 6 5 Definitions for BLOCK RACK TYPE AND GROUP PARAMETER BLOCK PARAMETER The block parameter identifies the assays that can be processed in the same run Assays that cannot be processed in the same run are e Assays with different conjugate incubation time or different substrate incubation time e Assays with different incubation temperature e Assays with other different characteristics like for example different common reagent trays RACK TYPE PARAMETER The rack type parameter identifies the different types of racks GROUP PARAMETER Refer to appendix E 5 7 SETTINGS This menu allows to set the analysis laboratory name and the name of the Doctor responsible for the analysis which will appear on the program s printouts reports and summary prints of the working session The settings of the communication between computer and instrument can also be modified but the use of this option is only recommended to expert users By means of the Password menu you can introduce a new pass word 5 7 1 Break on Error In case of a low or missing reagent sample the instrument switches to a pause mode The user can decide to refill the missing component or direct the ELISYS 2 Plus to continue This option must be activated in AP2 ini file 1 Open the ini file with wordpad or notepad 2 Change the following command lin
18. samples Select profile Assay 4 Assay 5 Delete Profile Assay E OF Assay T Cancel Assay Ei Help Note Not all of the methods are necessarily compatible amongst themselves That means that it isn t possible to execute methods which present different characteristics in the same session E g itis not possible to process different sets of methods at the same time in the following situations more than two washing solutions more than two dilution liquids different incubation temperatures different conjugate or substrate incubation times The program signalises these incompatibilities and doesn t allow to continue the setting up of a session as long as the operation hasn t been cancelled or until the incompatibilities 4 The selected assays do not belong to the same block Ap x have not been removed At the end the program enables to change the sequence of the set methods in order to reduce the execution time of the session reduce the number of changes of the washing solution minimise reduce at a minimum the solution quantity necessary to prime In those cases the following message appears to the user confirming the change varning Selected assays have been shifted to accomplish different incubation time and to minimize wash buffer prime number Take care at the exact assay positions User Manual ELISYS 2 PLUS 23 74 5 2 2 Set Parameters After click
19. shows the void positions 5 1 3 PC Program Starting The ELISYS 2 PLUS icon is available on the desktop Double click on it to run the program The main menu will appear a Human Elisys 2 Session Databases Settings Commands Help 5 1 4 Operating Menu Tables 5 2 and 5 2a show the instrument operating menus and their function O osn a ee EZ ZZ EEE Ma Medical Head e prire About Reports Lab rare Fr oe Mocify Soft ere Washer prime Show lab results la 1 Baer Morcplde Lab printing T Serial port anne Printer setup Assays Password Microplate a Ange Steps Terrpersure Ext incubation E Run Movenrent best Lest resus Exit Menu function explanation User Manual ELISYS 2 PLUS 20 74 Session New Modify Show lab results Lab Printing Printer Set up Single Steps Run Last results display Exit Databases Medical report Patient card Notes Assays Settings Lab name Doctor s name Serial port Password Ext incubation Commands Needle prime Washer prime Micro plate washing Micro plate aspiration Temperature test Movements test Help About Software N Human To start anew work session To modify the setting of the last loaded session if processed or not If no session has been programmed it assumes the New function as the previous paragraph Display of existing Labfiles To print all the information concerning each analysis session already proc essed
20. transfer the analysis result print and file the results memorise the calibration curves 10 74 User Manual ELISYS 2 PLUS 3 2 N Human INSTRUMENT TECHNICAL SPECIFICATIONS PROCESS CAPABILITY WORK AREA Microtiter plates Sample tray Common reagent trays Specific reagent trays Predilution plates Combination up 8 assays on 2 microtiter plates on line Modular composition 2 microplates with 96 wells 12 strips each one with 8 wells one tray for 60 primary tube 10 12 x 100 mm replaceable with a 40 primary tube 14 16 x 100 mm tray different types depending on the assay category for substrate stop solution cleaner dilution solution bottles common reagents different types depending on the specific assay for calibrators controls specific reagents 2 plates each one with 20 wells PREDILUTION DISPENSATION DISPENSATION SYRINGE Total volume Minimum volume Accuracy PIPETTING SPEED Samples Reagents CARRY OVER LIQUID SENSORS Sample dead volume Reagent dead volume MICROPLATES WASHING NEEDLE WASHING REAGENT WASTE EXTERNAL TANKS Wash buffer 1and 2 Wash solution Waste INCUBATION Programmable for each sample Three freedom degrees Arm x y z axis carrying the needle 1000 ul 10 ul Better than 1 at a volume of 100 ul 35 minutes for 96 wells for a washing volume of 1 ml 7 minutes for 96 wells for a washing
21. 21 24 HEEEEEENEEEEENEEEEEENEEEEHEEEENEEEEEENE 26 74 User Manual ELISYS 2 PLUS N Human j i Self ncrease Fage 1 eI ee Patient card A g Code 4 a pais steps 1 FaTIENTON gt pr Iw Fa Sample predilutions Oh 16 53 3 y Samples and controls Oh 44 47 2 PATENTO WM m we Conudatela 0h 1237 3 PATIENTODZ gt Fr Iw F Substrates h 1 39 r i Stop solution s Oh 12 32 4 PATIENTOS W Fr iv E 5 Patents gt W m Ca Fan 6 PATIENTOS gt I I fr 7 PATENTO gt W m Iv er z Run later a PATIENTOS gt fw F fr im a Cancel a PATENTO gt W IF 7 Cancel 10 FATIENTIO gt ia a Ir Br Used wells 000053 53 53 Full strips 217 24 IILI TTT 4447 to dispense sera MENSES REPRE RRR RRR ee this button the following menu appears Samples predilutions Selecting this item the machine will execute the sample Oh 16 53 predilution in accordance the selected assay settings 2 Samples and controls Selecting this item the machine will execute the dispensa Oh 44 47 tion of the samples and controls in accordance to the se lected assay settings Conjugate s Selecting this item the machine will execute the dispensa Oh 12 37 tion of the conjugate in accordance to the selected assay settings Substrate s Selecting this item the machine will execute the dispensa Oh 12 39 tion of the substrate in accordance to the selected assay settings
22. 5 Patient Reports In the Show the results panel appear the patient data and the results of the executed tests Code PATENTO Pal Code tass E The average and CV are displayed if the test erty fear EGC has been executed in double mode poem Sees fee ee Alrepats Qualitative tests show the cut off value and en the test results positive negative or equivocal Quantitative tests show the concentration Next or Previous Laboratory Report All reports Patient data Delete analysis OK by means of these two buttons can reports be displayed all the Work Session executes the laboratory print prints the displayed report prints all the requested reports allows to insert or modify the patient s data and the associated notes in the report See paragraph 5 2 3 1 to delete a specific sample result to avoid its memorisation and print out Note 1 It is possible to delete a test but to modify its result accepts and stores the data of all the patients of the present working ses sion The filed data cannot be altered any more Note 2 Attention Only the data related to the patients with a filled in patient data card are memorised no report of the present working session is filed Note 3 However all the data remain in the memory until a new working session Starts They can be displayed again by selecting the option View test results from the Session Menu 34
23. 666 6 e E iG GC CCC C16 6 Ce eC ee A D DD OIE A A 6101610160106 6106 E l lee AAMA EAA A M AA A A z i jeie L AAA EEA A A A A A o G10 GC CCC Oeae 4 PO OBO FOO OOOO Strip 1 2 3 4 5 6 7 8 9101142 1314151617 1819 20 21 22 23 24 EM Are ostrips 1 2 rund O cEA strips 3 5 run 1 Run analysis r Put the following reagents IgG diluition SUBSTRATE STOP SOLUTION lg diluition CLEANER NASHING S IgG Wash Igh Wash Substrate 600 ul Stop sol 800 pl H Mertral wells LUTIONS Nash buffer 1 Nash buffer 2 Previous Run analysis Put the following reagents on rack in position 1 Assay EBY IgG Conjugate 400 pl Negative Previous Positive Gt Cancel User Manual ELISYS 2 PLUS 31 74 5 3 2 4 Sample Sera The window below shows the disposition of the samples on the sample rack 5 3 2 5 Dilution Cups The number of pre dilution cups necessary for the session is indicated subsequently Before starting make sure the machine has been primed 5 3 3 Analysis Execution Running Phase Before the start of the working session the levels of the tank liquids are automatically controlled there might be warnings for the user with respect to tanks which are or too empty or too full apriming is performed by default if selected m Put the sample sera PATIENTOI PATIENTOS Pu
24. 74 User Manual ELISYS 2 PLUS NS Human 5 4 DATABASES Session Databases Settings Commands Help A Medical Reports Ctrl F Patients cards Ctrl P Motes _tri T ASZSAYS The following databases are available with the program a Medical reports Contains all the stored medical reports for each patient b Patient card Contains the stored patient s data c Notes Contains useful sentences used in the report comments d Assays Contains the parameters for each method NOTE It is possible to consult modify and add elements to all the databases with exception of the Medical Re port database Medical report database Number of matched reports 5 4 1 Medical Reports The window lists the filed patients with at least 2151212521 one report Select a patient and press Show to display the list of his reports Press delete to eliminate the selected Records Note to use this function the patient card has to be filled in first oes Cancel The displayed reports appear with their date and FH hour of the executed sessions This helps to an Hine select the report to examine Bree hanes Sse N More data Select a report and press PRINT to print out the repo rt Reports eport of 22 04 1999 12 50 Report of 22 04 1999 12 52 Select a report and press OK to enter the fol lowing window which displays the contained data User Manual ELISYS 2 PLUS 35 74 The medical report of the patie
25. 92 prediluted samples This rack is not part of the standard equipment It can be ordered with cat No 173017104 Regardless of the serial number each ELISYS 2 PLUS can be updated The following steps are required to enable this rack in the software 1 Open the ini file with wordpad or notepad 2 Change the following command line PredilutionRack 0 Standard 20 position segments PredilutionRack 2 92 Position Rack 5 7 5 Substrate Incubation at 37 Some ELISA tests also require the substrate incubation time at 37 The ELISYS 2 PLUS software also supports this kind of ELISA test The following steps are required to enable this feature 1 Open the ini file with wordpad or notepad 2 Change the following command line ThirdThermolncubation 0 the substrate incubation takes place at room temperature ThirdThermolncubation 1 the sample and conjugate incubation temperature is maintained also for the substrate incubation time 56 74 User Manual ELISYS 2 PLUS N Human 5 7 6 Dilution and Wash Buffer Names A new database for dilution and wash buffer names was introduced It is possible to predefine up to 5 different names for each liquid The predefinition appears in the reagent name compartment in the assay parameter set tings section Session Databases Settings Commands About fa Lab name Doctorname Dilution Names Buffer Names Serial port Password Ext incubation 5 8 COMMAN
26. Blank WASH Wash buffer 1 T3 T1 Precision Syringe Wash buffer 2 T2 Peristaltic Pump for needle external washing Peristaltic Pump for Microplate washer WASTE T4 Wash buffer 1 bottle for the microplates washing solution see note 1 Wash buffer 2 bottle for the microplates washing solution Wash bottle for the needle external washing solution see note 1 Waste tank to collect the waste Level control connector fig 4 2 User Manual ELISYS 2 PLUS 15 74 Before switching on the instrument fillup the T1 T2 T3 bottles with the right solution according to the method requirement place the T4 empty container waste connect the tubing to their relevant container as shown in figure 4 2 make sure that the tubing are properly connected and that they are in good condition plug the lead of the level sensor to the instrument socket connector R 4 5 bottle T1 has to be substituted with an equivalent bottle containing distilled water or decontaminating solution for manifold cleaning see Sect 6 bottle T3 has to be substituted with an equivalent bottle containing decontaminating solution for needle internal and external cleaning see Sect 6 WORK AREA Figure 4 3 a and fig 4 3 b show a typical work area layout Needle Microplates Note 1 At
27. DS Session Databases Setting Commands Help i Prime needle ee Fal Al Prime washer Wash MicroPlate Aspirate MicraPlate Temperature inspection Movements test This menu contains a series of commands for simple operations and diagnostic instruments to check the func tion of the instrument The first set of commands contains Prime needle Prime washer Wash Microplate and Aspirate Microplate The use of the first two commands is highly recommended before starting each working session to prime the instrument with the working solutions Its use is also recommended at the end of each working session to change the working liquids with distilled water to clean the instrument and to prevent the inside of the machine from the forming of solid residuals The second set of commands can be selected to use the machine as a simple plate washer It is possible to set the number of strips on which commands can be entered The third set of commands contains Temperature test and Movement test The first command allows to control the functioning of the instrument s thermoregulation setting a temperature threshold to be reached The second one executes the motor test of each machine telling the user about possible bad function User Manual ELISYS 2 PLUS 57 74 SECTION 6 6 MAINTENANCE Only qualified personnel is entitled to carry out maintenance see Section 1 of this manual Carrying out the maintenance operations follow the ge
28. ERFACE ELECTRICAL POWER REQUIREMENT POWER CONSUMPTION RS232 Standard 220 or 110 Vac 50 60 Hz 500 W Max OPERATING CONDITIONS Temperature Relative Humidity SHELF CONDITIONS Temperature Relative Humidity DIMENSIONS Width Height Depth WEIGHT Instrument Packed instrument EUROPEAN REFERENCE DIRECTIVES HARMONIZED STANDARD SPECIFICATIONS INSTRUMENT OUTFIT PC optional supply from 15 C to 30 C up to 80 from 10 C up to 60 C up to 85 790 mm 595 mm 980 mm with lifted up lid 600 mm 650 mm with lifted up lid 72 Kg 97 Kg wooden box dimensions 89x68x75 cm 73 23 EEC regarding low voltage electrical material 89 336 EEC regarding Electromagnetic Compatibility 93 68 EEC regarding the CE mark Safety EN 61010 1 1994 CEI 66 5 Safety requirements for measurement electrical equipment checking and laboratory use Electromagnetic Compatibility Emission EN 55011 1989 CEI 110 6 Immunity EN 50082 1 1992 CEI 110 8 The instrument is equipped with e User s manual Mains power cable Modular reagents trays kit Two predilution plates A tray for 40 samples Two 2 liter bottles for wash buffer 1and 2 A 5 liter bottle for wash solution A 10 liter waste tank RS232 PC connection cable Software for PC to master the instrument On request BDE Installer for Microsoft Windows 98 II Edition The PC minimum requirements are e Micro
29. No 20 GROUP No 131 APPENDIX F ON LINE MODULE PROCEDURE APPENDIX G OPERATING FLOW DIAGRAMM 2 74 User Manual ELISYS 2 PLUS N Human REVISION LIST OF THE MANUAL 030217 NEW Integration of new ELISA Tests 1 eA 1 28 10 2003 Update ELISYS 2 PLUS BEE SSS User Manual ELISYS 2 PLUS 3 74 0 INTRODUCTION 0 1 DESCRIPTION The purpose of the automated microplates analyzer ELISYS 2 PLUS is to analyse samples on microplates it has been specifically conceived to automatically process up to 2 plates on line This manual provides the operator with all the necessary instructions for a safety suitable use as well as the instrument maintenance recommendations Manual content introduction warranty information and the CE conformity declaration section 1 general safety warnings section 2 general information such as the producer data instrument description section 3 instrument performances technical data section 4 installation and start up section 5 operating instructions section 6 the user s periodic maintenance and checking and the repair policy section 7 how to put the instrument out of service packaging transport instructions section 8 Appendices including instrument decontamination and spare parts list This manual is considered as a part of the instrument it has to be at the operator s hand as well as at the main tenance operator s availability For accurate i
30. ONTAMINATION might occur Pay attention to the general safety warnings as to the presence of such biological substances Use protective clothes gloves and glasses In particular Wear protective clothes and gloves At the end of a work Session clean the work panel and its accessories carefully by using a cloth soaked in a 0 5 sodium hypochlorite solution Waste material produced by the analytical and cleaning process is a dangerous material which might contaminate people and material Get rid of the waste material according to the local regulations 5 1 1 Operating Overview Table 5 1 shows the general operating sequence PC switching on and program start WORK SESSION OTHER FUNCTIONS Start work session or other functions VW Work session setup Par 5 2 Par 5 4 Databases Par 5 5 Settings Run Analysis Par 5 3 Table 5 1 General operating flow diagram User Manual ELISYS 2 PLUS 19 74 5 1 2 Powering the Instrument Switch on the instrument the switch is located on the right side On the front side of the instrument there are three coloured lamps as below specified indicating that the instrument is switched on POWER green lamp RUN yellow lamp indicating that the instrument is in running phase indicating that no liquid is inside some container of the work panel ERROR red lamp Note 1 Note 1 The machine won t stop but the display
31. PTY BOX This box is designed and manufactured for this instrument only and should be used in future transportation User Manual ELISYS 2 PLUS 13 74 4 2 PLACING THE INSTRUMENT The instrument has to be placed on a levelled bench assuring enough free space around the instrument to allow maintenance operations 35 50 cm on the rear and on the lateral sides Room temperature has to be between 10 and 30 C with relative humidity below 80 protect it from direct sun shine 4 3 POWER SUPPLY Once the instrument and its outfit have been placed plug it to the right power source using the supplied cable fig 4 1 W Warning make sure that the electrical power source is the one as requested and indicated on the label beside the instrument power socket 220 V or 110 V Y Warning make sure that the fuses value corresponds to the one indicated beside the fuse holder 220 Vac mains 2 quick fuses 3 5 A 110 Vac mains 2 quick fuses 7A 14 74 User Manual ELISYS 2 PLUS 4 4 WASH AND WASTE CONTAINER INSTALLATION N Human In figure 4 2 are shown the washing discharging containers and their connections with the instrument T1 T2 T3 T4 WASTE WASTE buffer 1 buffer 2 O S B Wash
32. Prime gt y BLANK STANDARD VALUES next NO YES Tank level controls Prime execution y Time flow for every operation a eee eects Session end remaining time Errors in process liquid not found D c B A couple of windows A A A B B C C etc gt CONTROLS for each assay previous is presented CALIBRATION CURVE for quantitative analysis only ACCEPT Go to th STORE RESULTS e next assay NO Accept or Reject 9 REJECT REJECT RESULTS LAB PRINT 03 a PATIENT 01 REPORT next lt gt PATIENT REPORT PRINT x M Go back to the MAIN MENU Par 5 1 to locate microplates into their own locations to locate reagents on the reagents trays to locate controls and calibrators assay A to locate controls and calibrators assay B to locate the samples into the tray to locate the predilution plates Don t forget to locate the washing solution bottle locate the wash buffer1 buffer2 bottles locate the waste tank make sure they have been filled make sure it is empty DISPLAY EVALUATE RESULTS Par 5 3 4 ACCEPT REJECT RESULTS Par 5 3 4 PATIENT REPORTS Par 5 3 5 Table 5 4
33. User Manual ELISYS 2 Plus CONTENTS 0 INTRODUCTION 0 1 DESCRIPTION 0 2 USER WARRANTY SECTION 1 1 GENERAL SAFETY WARNINGS 1 1 DANGER WARNING SYMBOLS 1 2 INTENDED USE OF THE INSTRUMENT 1 3 USE OF THE INSTRUMENT SECTION 2 2 GENERAL INFORMATION 2 1 INSTRUMENT DESCRIPTION PURPOSE AND FEATURES 2 2 MANUFACTURER S IDENTIFICATION LABEL 2 3 INSTRUMENT DESCRIPTION 2 4 INSTRUMENT MEASURING PRINCIPLE SECTION 3 3 INSTRUMENT TECHNICAL DATA 3 1 MAIN FEATURES 3 2 INSTRUMENT TECHNICAL SPECIFICATIONS SECTION 4 4 INSTALLATION AND START UP INSTRUCTIONS 4 1 UNPACKING 4 2 PLACING THE INSTRUMENT 4 3 POWER SUPPLY 4 4 WASH AND WASTE CONTAINER INSTALLATION 4 5 WORK AREA 4 5 1 Samples Tray 4 5 2 Trays for Reagents and Controls 4 5 3 Pre dilution Plate 4 5 4 Microplate 4 5 5 Wash Basin for the Needle 4 5 6 Reader Washer Group 4 6 ELISYS 2 PLUS PC CONNECTION 4 7 SOFTWARE INSTALLATION ON PC 4 7 1 PC Minimum Requirements 4 7 2 Software Installation SECTION 5 5 OPERATING INSTRUCTIONS 5 1 INTRODUCTION 5 1 1 Operating Overview 5 1 2 Powering the Instrument 5 1 3 PC Program Starting 5 1 4 Operating Menu 5 2 WORK SESSION SETUP 5 2 1 Select Profile 5 2 2 Set Parameters 5 2 3 Sample Setting 5 2 4 Single Step Operation 5 2 5 Entering the Patient Card 5 3 RUN ANALYSIS 5 3 1 Run the Process 5 3 2 Work Area Preparation 5 3 3 Analysis Execution Running Phase 9 3 4 Displaying the Results
34. and Their Acceptance Evaluation 5 3 5 Patient Reports 5 4 DATABASES 5 4 1 Medical Reports 5 4 2 Patient Cards 5 4 3 Notes 5 4 4 Assays OCONNNNDOTATGAIH HHA 5 9 ASSAY PARAMETER SETUP 5 9 1 Working Parameters 5 6 RACK ARRANGEMENTS 5 6 1 Disposition on the Working Area Standard Racks 5 6 2 Disposition on the Working Area Universal Racks 9 6 3 Disposition on the Working Area Mixed Arrangement 5 6 4 Working with Two Substrates 5 6 5 Definitions for BLOCK RACK TYPE AND GROUP PARAMETER 5 7 SETTINGS 5 7 1 Break on Error 5 7 2 External Incubation 5 7 3 Simulation Mode 5 7 4 92 Positions for Predilution 5 7 5 Substrate Incubation at 37 5 7 6 Dilution and Wash Buffer Names 5 8 COMMANDS SECTION 6 6 MAINTENANCE 6 1 CHECKS AND PREVENTIVE MAINTANANCE 6 2 CLEANING THE INSTRUMENT S PARTS 6 3 TUBING DILUTER AND MANIFOLD DECONTAMINATION 6 4 GENERAL INSPECTIONS AND CHECKS 6 5 REPLACE THE SYRINGE TIP SECTION 7 7 PUTTING THE INSTRUMENT OUT OF SERVICE 7 1 GENERAL WARNINGS 7 2 PUT THE INSTRUMENT OUT OF SERVICE 7 2 1 Momentary Stocking 7 3 INSTRUMENT TRANSPORT AND HANDLING 7 4 INSTRUMENT STORAGE APPENDIX A INSTRUMENT DECONTAMINATION DECONTAMINATION PROCEDURE DECONTAMINATION DECLARATION APPENDIX B SPARE PARTS CONSUMABLES ACCESSORY PARTS APPENDIX C ELISYS 2 PLUS RACK DESCRIPTION APPENDIX D GROUP RACK BLOCK DIVISION APPENDIX E DEFINITIONS FOR GROUPS GROUP No 1 GROUP No 2 GROUP No 3 GROUP No 4 GROUP No 5 GROUP
35. atient code Further clicks on that button will add a different progressive code for the following patient Selt increase CMY IgM EBY IgM __ Patientcard CMY IgG EBY IgG Code a a a Single steps 1 PATIENTO gt Vv C v Vv Dispense 2 PATIENTO2 gt Vv Vv Vv Wash 3 PATIENTO3 gt Vv Vv Vv Vv Ber 4 PATIENTO4 gt Vv Vv 5 PATIENTOS gt Vv B v Run 6 PATIENTO6 gt Vv Vv v a 7 PATIENTO gt Vv Vv Au 8 4PATIENTO amp G al m wg g PATENTO B T v E v gez 10 PATENTI B m Vv m fig Used wells 10 10 12 Full strips 7 24 LLLITTILIIT III J 13 51 to dispense sera They keys on the right and the left of the page number allow to show following or previous sample positions By means of the arrow on the right side of the patient code you chose that sample for all the analysis Analo gously using the arrow under the method name all the samples appearing on the page are chosen for this type of analysis It is possible to select one by one the coupling of the sample and the method by clicking on the box at the centre of the window The current number of the used wells is shown under each column related to the method At the bottom of the window there are two fill up indicators The first one is referred to the presently occupied strips the second one to the necessary time for the dispensing of the samples controls and calibrators for the session No
36. be placed on the following positions from 6 up to 1 a maximum number of 6 universal reagent racks can be positioned HRE Oferererere OO Ht HAHAAHA euer sen C O OC O DIT OOOC oe oe SO oe oe OQ Q EOE SS ISO SS SO MP 1 2 3 4 5 6 BEE Samples Rack Reagents Rack mmon R k Universal GO 2 ae Universal Fig 4 5 6 3 Disposition on the Working Area Mixed Arrangement A mixed arrangement can only made when using Rack 6 or 7 together with the common rack universal pos 7 8 It is possible to have a mixed configuration made up with standard and universal racks In this case as shown in Fig 5 the common universal rack is placed on the right side the standard common rack is placed on the left side between them a combination of standard and universal reagent racks can be posi tioned according to the needs SEES O oO AOC BES DED OOo DI RO RO ISO OR OO Pate celce oe SE in Rees 6 C KO HM z T FT Samples Reagents Rack tommen Rack Seen aoe Reagents Rack ee eee Standard Universal Universal Fig 5 Note 1 The position of the two common racks is fixed and not interchangeabl
37. ce for the correct functioning of the instrument this file is protected_by a pass word The access is only recommended to the person nel with a thorough knowledge of the functioning of the program and the instrument Once the password has been entered selection HSV2 IgG window of the assays is displayed Messies ine hG m Mumps Vius la 0 New allows to add assays Copy can be used to copy settings from the se lected tests into a new a one The name of the 2 new test has to be different from the source It is recommended NOT to modify any setting if you do not have a sufficient knowledge of Save allows to store the selected test the functioning of the program and the in On a floppy disk or in a different directory on the strument harddisk Load enable to upload tests from a floppy disk or from another directory Modify displays and modifies the settings of stored assays Delete cancels a stored assay Print enables a complete printout of all data re lated to the selected tests User Manual ELISYS 2 PLUS 37 74 5 5 ASSAY PARAMETER SETUP This window allow to set the parameters of a new method Assay parameter settings arte EBV IgG 4 Blo 2 solution Hl p fen Volumes Ul Block number Identifies the assays that can be processed in the same run The following aspects are the limits to process assays in the same run not more than two washing solutions not more than two dilut
38. duct This warranty does not apply to damages incurred in shipment of goods Any damage so incurred shall be re ported to the freight carrier for settlement or claim 4 74 User Manual ELISYS 2 PLUS SECTION 1 GENERAL SAFETY WARNINGS DANGER WARNING SYMBOLS 1 1 1 N Human In this manual the following symbols are to remind the user of the safety rules 1 2 gt b amp i ww a J This is asymbol of generic DANGER It means that serious dangers might occur to the opera tor if the described precautions are not fulfilled This is a symbol of high electrical voltage by touching parts reporting this label life endanger might occur Parts reporting this label can be handled only by qualified operators after having unplugged the power supply cable This symbol indicates that the instrument makes use of chemical reagents and other danger ous corrosive irritant and harmful CHEMICAL SUBSTANCES which can cause damages to people and material When this label is found pay attention to the producers recommenda tions This symbol indicates that the instrument involves the handling of samples which can be in fected urine and human serum In this condition INFECTIONS or CONTAMINATION might occur Pay attention to the general safety warnings when in presence of such biological sub stances Use protective clothes gloves and glasses This symbol indicates that damages to the instrument and or its incorrect results cou
39. e User Manual ELISYS 2 PLUS 53 74 BreakOnError 0 In case of a low or missing reagent sample the ELISYS 2 Plus continues pipetting The missing components are logged and can be identified later in Labfile BreakOnError 1 In case of a low or missing reagent sample the ELISYS 2 Plus stops and the user can decide to refill or direct the ELISYS to continue The missing components are logged and can be identified later in the Labfile Liquid Error Detected E3 Eror control n I of AFP not found 5 7 2 External Incubation Using the external incubation function allows to place the plates for incubation outside of the system i e on a shaker During the external incubation period the ELISYS 2 PLUS can be used to perform other tests i e wash ing another plate or dispense the samples The inserted tests can only executed in single step operation If the performance time for the selected step is longer as the remaining incubation time this step can not be started When the incubation time has finished the system informs the user to take the plates back to the system to con tinue with the assay processing This function gives the ELISYS 2 PLUS a greater flexibility and contribute to increase the capacity of the system To enable the external incubation two set ups have to be done 1 Inthe settings menu the ext incubation option has to be marked 2 Inthe assay parameter settings of the concerned test the thermostat checkbox has to
40. e universal common racks always on the right standard common rack always on the left Note 2 The maximum number of standard reagent racks is 8 if there are no universal racks Note 3 The maximum number of universal reagent racks is 6 if there are no standard racks position 7 and 8 are busy with the universal common racks 52 74 User Manual ELISYS 2 PLUS N Human 5 6 4 Working with Two Substrates In order to direct the instrument to handle two substrates A B group parameter 131 must be assigned in the assay parameter settings This option only works if the ratio between Substrate A and B consists of equal por tions I E 50 ul A 50 ul B Assay parameter settings x I Plate pre washing Name E Block number R Rack type B Standing time ct 2335 ul 60 for solution Of Sol Hl Volumes i seconds Substrate 1 2770 uL Incubation times min Reagent names GT ee To Substrate 2 2770 pL M ilution incubation Conjugate 100 Gani conjugate feo Stopping HCL o a incubation Pal a Se 15 v Wash solution Homones Wash incubation l Substrate 2 100 Stop sol EN m Wash cycles Filters nm Sample fo Filter 1 450 X Dilution volumes washing Conjugate f Serum fo r washing Filter 2 630 350 v Diluent poo On fly Volume l Empty wells atthe end Working parameters WASHING SOLUTIONS l Thermostat 37 C Quantitative
41. e controls and the standards are dispensed together with the dilution solution the dispensed volumes are described in the assay set up window If the dispensation is in double mode it is carried out with two single moves The sucking syringe speed is SV500 the dispensation speed is SV2500 Conjuga2 ap2 dispensation volume 100 ul e Also the Conjugate dispensation into the blank wells is carried out e The syringe suck up speed is SV1000 the Conjugate dispensation is carried out with just one move the dispensation speed is SV3000 Chromoge2 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Chromogen dispensation is carried out with just one move the dispensation speed is SV3000 Stop2 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Stop Solution dispensation is carried out with just one move the suck up speed is SV2500 68 74 User Manual ELISYS 2 PLUS N Human GROUP No 3 Used for LH FSH Prolaktin hCG T4 T3 TSH AFP CEA PSA fT3 fT4 Predilu3 ap2 e This group does not involve the sample predilution Sample3 ap2 dispensation volume from 25 ul to 50 ul e f the controls or standards and samples dispensation is in double mode it is carried out with two single moves The suck up syringe speed is SV250 the dispensation speed SV2500 The blank wells are left empty Conjuga3 ap2 dispensation volume 100 ul e The Conjugate dispensation on the blank wells is
42. e pre diluted volume is slightly superior to the minimum necessary to execute the session If it is not necessary to pre dilute the sera for the method it is sufficient to set the serum volume on 0 On Fly Dilution with a low dilution rate can be performed directly No dilution segment is needed in this case e Volumes Sample quantity of aspirated diluted sample in ul Conjugate quantity of aspirated conjugate in ul Substrate1 quantity of aspirated substrate in ul Substrate2 quantity of aspirated substrate in ul stop solution quantity of aspirated stop solution in ul User Manual ELISYS 2 PLUS 39 74 Wash cycles Sample washing number of wash cycles on the strip after sample dispensation Conjugate washing number of wash cycles on the strip after conjugate dispensation Volume quantity of washing solution in ul Empty wells at the end if the box is checked empty wells at the end of the washing cycles will result 8o Incubation time Incubation time in minutes for sample conjugate substrate The tree selected values are to be compatible with the block number characteristics Reagent name Dilution editable name of the dilution liquid Stopping editable name of the stop solution Wash solution editable name of the wash solution It is obligatory to fill the three fields The three names are used by the program to check that in the selected work session profile no more than 2 diff
43. e results of the set controls are visualised It is possible to exclude the obtained values removing the selection in the control fields located on their left Depending on the values displayed and which might have been modified it is possible to accept or reject the results of the examined method pressing the buttons Accept assay or Reject assay NOTE Run analysis Show the controls an Standard values OD1 0 005 0 078 0 240 0 430 0 645 wt Click on the check d curves Assay T3 boxes to discard the wrong values Click on a single value to invalidate validate it Assay 1 1 N Human Draw the curve gt Draw curve Note Whenever a double dispensation is chosen the display shows the two measured absorbances their average and Show the controls and curves Assay EBY IgG Controls ilv Negative 0 045 MEAN 0 058 CY 16 5 M 0 067 1M Positive 0 053 MEAN 0 047 CY 12 3 Iv 0 041 co 0 062 Equivocal zone 0 053 0 072 Cancel ou SE ee Previous Reject assay Accept assay Assay 1 4 the Previous button allows to display again the window related to the blank and the calibrator the Cancel button allows to escape from the visualisation phase of the results without accepting any analy SIS the OK button is not active until all the methods have been accepted User Manual ELISYS 2 PLUS 33 74 5 3
44. ected sample tray It is not allowed to load more samples than the ones accepted by the used tray Below is an example to clarify a WLT file structure along with the resulting LAB file 72 74 User Manual ELISYS 2 PLUS N Human Assuming to load a work list for 3 assays Toxo_IgG Rubella_IgM CMV_IgM the first assay will be carried out on all samples the second assay will be carried out on the following samples 1 3 4 6 7 9 10 12 13 15 16 18 and 19 The third assay will be carried out on the samples 1 4 7 10 13 16 and 19 The WLT will generate the following content lt Assays gt 1 Toxo_IgG 2 Rubella_IgM 3 CMV_IgM lt Patients gt 1 PATIENT01 1 2 3 2 PATIENTO2 1 3 PATIENT03 1 2 4 PATIENT04 1 2 3 5 PATIENT0O5 1 6 PATIENT06 1 2 7 PATIENT07 1 2 3 8 PATIENT08 1 9 PATIENTO9 1 2 Once the session has been completed a file with a LAB extension will be automatically generated The file name will be composed of the execution date and the changing of the last 2 digits for the progressive number e g the first work session of February 14 2002 will generate the file name 2002021400 LAB User Manual ELISYS 2 PLUS 73 74 APPENDIX G OPERATING FLOW DIAGRAMM
45. em are common for all the assay methods of the session wile other trays contain the reagents for the specific assay methods The reagent vials have to be placed on particular positions as shown as typical example in fig 4 3 a and ac cording to the given program instructions see paragraph 5 3 for the specific assay method 4 5 3 Pre dilution Plate The pre dilution plate is a moulded 20 wells plastic container The needle dispenses the sample along with dilu tion solution into each cup according to the running program There are two pre dilution plates so that a total of 40 pre dilution cups are available The program advises to locate the pre dilution plates before starting the process see paragraph 5 3 4 5 4 Microplate The microplate is a support for 96 reaction wells One or two microplates have to be located on their relevant places IP ON a Ne OOO EN ey OOQ HOOOOOOAs SOSSE SOOOOOSOAR The washer and the photometer are able to run through the plate in order to read and wash the related wells OC IL I 7 X AS Each microplate can host up to 12 strips each strip containing 8 wells 00100 SOOOOOH o a gt SAG lee The PC program advises to locate the micro plates before the start of the running process see paragraph 5 3 IO Tn mMmMO ODU gt TIITITITII SH 7 Ns 2 O A
46. emark Clicking on New the memory contents of the application are reset and the previous results and set ups are lost From the Session menu click on Modify to access the Profiles Selection window The stored setting up of the previous working session can be modified SESSION SELECT PROFILE SELECT PROFILE Par 5 2 1 Ea SE T y CALIBRATION CURVE PA RAM ETERS ETENEE lt gt for Quantitative assays only Par 5 2 2 page 1 4 y Ac SAMPLE SETTING lt gt PATIENT CARD Par 5 2 3 Par 5 2 3 1 OK PATIENT DATABASE y RUN ANALYSIS Par 5 3 Table 5 3 Session set up 22 74 User Manual ELISYS 2 PLUS N Human 5 2 1 Select Profile A profile is a set of assay methods maximum 8 to be processed at the mean time with the same set of samples To recall a message memorised previously it can be selected in the Select profile list on the left side of the window By clicking on the Delete Profile button it is possible to erase a profile memorised previously Use panel Sample rack to choose between operating with a 40 samples or a 60 samples rack Once the Assays have been set press OK to save the profile This is very useful wnen the same type of analy sis is run frequently Select profile Assay 1 CMV IgM Assay di Sample rack 40 samples Assay 3 60
47. erent dilution buffer or no more than 2 different wash solution are present If these condition are not met the program does not accept the selected profile Filter 1 nm Select the type of primary filter es 450 nm Filter 2 nm Select the type of secondary filter es 630 nm If the secondary filter is not selected the program will perform only a monochromatic measure a Thermostat Thermostat if the box is checked the thermal regulation is active In the near box the temperature value in C has to be selected 42 Plate prewashing If the box is checked the micro plate prewashing is active In the near box the standing time for solution in seconds has to be selected It is possible to write comments and memoranda related to the assay 14 Quantitative parameters See next pages 15 Qualitative parameters See next pages 16 see 5 5 1 Working parameters N 40 74 User Manual ELISYS 2 PLUS N Human Using the Quantitative parameters button it is Quantitative assay parameters FSH possible to set the data regarding the following calibrator concentrations for the method curve type to be designed for the sample evaluation normally expected values concentration measuring unit Point to Point F Note 1 In case the method requires only one calibrator with a known concentration semi quantitative analysis it must not be introduced in that window See Cut off calculation par
48. ing OK for confirmation of each method set in the previous window Select profile the window Set parameters appears page 1 n For each method it is possible to set the following note 1 the repetition of the blanks controls samples e of the calibrators if the execution modality foresees a quan titative analysis the execution modality qualitative or quantitative note 2 the reagents lot and its expiry the Cut off factor note 3 when to use the controls at the beginning at the end every N samples Clicking Next or OK you go on to the next assay method page 2 n Note 1 The program stores latest selected options of the requested method and displays them automatically In any case it is possible to modify them Note 2 The program only allows the execution of the quantitative evaluation method if the corresponding data have been set Running parameters Lot 1 Assay FSH i Lot Pag 172 Repetitions Expiration Curve C Single Cut Off factor fi Duplicate ee r Controls Samples Single u M Begin Duplicate I End Controls Single i Every i samples Duplicate Blank C No Execution mode Single Qualitative i C Duplicate f Quantitative i AR Cancel Note 3 Cut Off factor field For most of the methods executed in qualitative evaluation it is necessary t
49. ing sdution 7 locate the wesh buffer1 buffer2 ie gt locate the weste make sure they have been make sure it is empty u DISPLAY EVALUATE RESULTS Pa 5 3 4 ACCEPT REJECT RESULTS Pa 5 3 4 PATIENT REPORTS Par 5 3 5 OPERATING FLOW DIAGRAM 74 74 User Manual ELISYS 2 PLUS Human Gesellschaft fur Biochemica und Diagnostica mbH Max Planck Ring 21 e D 65205 Wiesbaden Germany Telefon 49 6122 9988 0 Telefax 49 6122 9988 100 eMail human human de Internet http www human de 01 2003 10
50. ion liquids no different incubation temperatures no different conjugate or substrate incubation times Note 1 If two assays are required to be processed in different runs it is sufficient to assign them two different block numbers 38 74 User Manual ELISYS 2 PLUS N Human 2 Group parameter Identifies the execution modality of the method as far as concerns the modality for pre dilution if any sample dispensation conjugate dispensation substrate dispensation stop solution dispensation The new assay method has to be classified within an existing group in order to utilise the al ready defined parameters typical for that group Note in Appendix 1 to this document the Groups already defined are listed 3 Racktype o Identifies by a numeric code the types of racks specific and common to be used for the method S Note if the Universal racks are used set to 6 the rack type code Field to be filled with the name of the assay to be set Serum volume quantity of aspirated sample in ul Dilution volume quantity of aspirated dilution solution in ul The ratio between Dilution volume and Serum volume represents the Predilution Ratio Es Serum volume 10ul Dilution volume 1000ul Predilution Ratio 1 100 The volumes specified for the serum and the dilution solution present indicative quantities of the dilution ratio volumes foreseen in the method The program controls automatically that th
51. lcohol Every run As the instrument could be used in different conditions and terms maintenance has to be done according to the use of the instrument the period indicated on the above table has to be taken as an average After an inactivity long period a general maintenance is required before using the instrument again 58 74 User Manual ELISYS 2 PLUS N Human Some parts of the instrument although not visibly damaged have to be replaced by a qualified service level technician before the use according to the below table 2 level maintenance operations Period service level Replacing internal connecting tubing 12 months Replacing Lamps 12 months that is 500 hours 6 2 CLEANING THE INSTRUMENT S PARTS W l l a Warning cleaning the instrument do not use alcohol or similar solutions A use of 0 5 sodium hypochlorite solution is recommended N When cleaning don t let electric parts connectors etc get wet if necessary before turning on the instrument dry them out et After each work session clean disinfect the instrument carefully Use a water soaked cloth or light detergent to clean the instrument external parts Toclean the wells use a water soaked cotton cloth then dry it make sure not to leave any particle inside 6 3 TUBING DILUTER AND MANIFOLD DECONTAMINATION To perform a decontamination fill bottle T1 and T3 with the decontamination solution For decontamination can be used
52. ld occur if the given warnings are not respected This symbol is to advise that the instrument or part of the manual which is particularly important has to be consulted INTENDED USE OF THE INSTRUMENT The instrument is intended to be used in the following working conditions reading of medical substances as specified in the technical data only use the chemical reagents and accessories supplied and or mentioned in this manual work at room temperature and humidity according to the specified data do not power the instrument in a potentially explosive environment or at risk of fire The instrument has to be used as described in this manual Any other use has to be regarded as im proper User Manual ELISYS 2 PLUS 5 74 1 3 USE OF THE INSTRUMENT The instrument has to be used for the expected purposes and in perfect technical conditions by qualified per sonnel in working conditions and maintenance operations as described in this manual according to the safety rules This manual contains instructions for qualified operators e Qualified User has to make sure that environmental condition is suitable the installation is correct the use and maintenance are proper according to the general safety rules as well as to the particular precautions de scribed in the manual although he is not entitled to repair the instrument e Qualified Technician is entitled to maintain and fix the instrument according to the instructions recei
53. lls Selecting this item the machine will execute the Oh 12 39 second washing cycle respecting the previously set time Session setu Sel increase Fage 1 i it bbi z Patient card m A Code 4 l l r Single steps 1 PATIENTOT I I ra Dispense 2 PATIENTO2 gt W m m en RATEN u a Read microplates Oh 1830 E Head 4 PATENTO gt I I Iv T 5 PATIENTS gt m Iv 7 Br 6 FAtENTG W Iv m z FATIENTO gt i Fr 7 r ae E Aun later e PATIENTOS I he mM d Cancel 3 PATENTO gt W Fr ca Cancel 1O PATIENTIO W I m He Usedwell 53 549 53 Full strips 21 24 fILITLILLIIILIIIIIIIilIiliiiiiiiitiiiie 4447 to dispense sera PEPER REE RRR RRR Pressing this button the following menu appears Read microplate s Selecting this item the machine will execute all the reading Oh 15 10 and will show all the result with the possibility to print the laboratory file and the results User Manual ELISYS 2 PLUS N Human 5 2 5 Entering the Patient Card It is possible to couple each sample to a patient report selecting the Code field in Cod the window and clicking on the Patient card nn Patient ID Group DataBase In the window which appears information Nme regarding the patient and the sample can EEE be inserted To accept the information given the fol Birth dey Sas gts a __ More notes _ lowing bo
54. lly infected Prior to any repair or maintenance intervention and before transporting the instrument a de contamination is necessary by using wide band disinfectant solutions Warning USE LABORATORY PROTECTIVE CLOTHES DISPOSABLE GLOVES AND GLASSES WHILE DISINFECTING THE INSTRUMENT Fill in adecontamination declaration and enclose it with the instrument If the declaration is missing the customs officers or your service centre can refuse the instrument DECONTAMINATION PROCEDURE Use one of the following wide band disinfectant solutions gt Aseptisol Manufacturer Bode Chemie Amburg gt Germocid Plus Manufacturer Germo S p a Milano gt Lysetol Manufacturer Schulke amp Mayr Ges m b H l WW Use the solution only for the instrument surface 1 Wear disposable gloves protective glasses and suitable clothes 2 Prepare an autoclave bag for the disposable items used for the decontamination and label the bag with an autoclave band mark Unplug the instrument in order to avoid explosions Remove all the accessories and disinfect the ones which have to be sent with the instrument I Spray the disinfectant solution on the instrument surface or use a cloth or paper soaked in a disinfectant solution 6 Leave the solution on the instrument for 10 minutes and repeat the treatment from the preceding point T Leave the solution on the instrument for 5 hours clean the instrument surface by a light detergent or water to
55. mary tubes or 60 samples in 10 mm primary tubes optional Samples predilution on two 20 well plates programmable for each assay REAGENTS Modular trays for calibrators controls conjugate chromogen stop solution reagents and sample dilution REACTION AREA Max location of 2 microplates with 96 wells each which can be incubated at programmable temperature DISPENSATION An arm with three directions x y z axis carrying a level sensor dispensing needle In the aspiration phase the sensitive needle stops at liquid meniscus level to reduce contamination WASHING Needle external surface by dipping it into the washing basin with flowing water internal surface by dispensing the washing solution in the washing basin discharge Plates one 8 channel dispensing manifold able to run two independent washing solutions one 8 channel manifold to drain a row of wells at one time OPTICAL SYSTEM Reader 8 photometric channels equipped with lenses interferential filters and lamps Results available at the end of the work session to be stored and printed EXTERNAL LIQUID CONTAINERS External containers are delivered with the instrument to contain washing solutions dispensing solution and the liquids waste each container is equipped with a level switch SOFTWARE A PC software run by WINDOWS 95 98 allows to set up the requested analysis and to process on line different methods give to the instrument the relevant commands receive and
56. mined for every assay on the basis of the calculation criteria specified by the manufacturer of the assay reagent kit Cut off calculation To calculate the Cut off the program uses the following general parametric equation OD cut off a x C1 b x C2 c Where a b c are three constants and C4 C2 the OD values of the measured controls in positions C1 and C2 Note 2 If the controls in positions C1 and C2 have been measured more than one time the instrument automatically uses their mean values For every assay this formula has to be adapted attributing specific values to the three constant factors inter preting the calculation criteria specified by the manufacturer of the assay reagent kit See Examples given in Table 5 5 Interpretation of Results Once the Cut off has been determined the program uses this value for the positive negative evaluation of each sample processed with that assay method If the positive condition corresponds to Sample OD gt Cut off OD OD sampie gt OD cut off X gt positive OD sampie lt OD cut off X gt negative If the positive condition corresponds to Sample OD lt Cut off OD OD sampie lt OD cut off X gt positive OD sampe gt OD cut off X gt negative Note 3 x represents the equivocal zone User Manual ELISYS 2 PLUS 43 74 Cut off Calculation Examples Example 1 cut off NC PC 2 1 Having 3 controls NC PC HC supposing to
57. neral warnings as described in Section 1 of this manual as well as the below safety rules The operating instrument makes use of chemical reagents and other dangerous corrosive irritant and harmful CHEMICAL SUBSTANCES which can cause material and personal damages When this label is found pay attention to the producer recommendations The operating instrument handles samples which can be infected urine and human serum In this condition INFECTIONS or CONTAMINATION might occur Pay attention to the general safety warn ings when in presence of such biological substances Use protective clothes gloves and glasses Prior to any repair intervention and or to transportation of the instrument disin fect the instrument following the applicable instructions See APPENDIX A 6 1 CHECKS AND PREVENTIVE MAINTANANCE See the below table for the recommended preventive maintenance operations Operation Cleaning the instruments parts Daily and or at the end of each work session Cleaning the needle outside Alcohol soaked cloth Begin and at the end of each work session Needle prime with distilled water Begin and at the end of each work session Washer prime with distilled water Begin and at the end of each work session Tubing diluter and manifold decontamination see page 47 If necessary Replace syringe tip see page 47 Monthly General inspection and checks At interval of 6 months Using cleaning solution Recommendation A
58. nstallation use and maintenance please read the following instructions carefully In order to avoid instrument or personal damages carefully read the GENERAL SAFETY WARNINGS Section 1 describing the suitable operating procedures In case of breakdowns or any troubles with the instrument apply to the local Technical Service 0 2 USER WARRANTY HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in material or workmanship provided that this warranty shall apply only to defects which become apparent within one year from the date of delivery of the new instrument to the purchaser The HUMAN representative shall replace or repair any defective item at no charge except for transportation expenses to the point of repair This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in the course of normal usage e g lamps valves syringes glassware fuses diskettes tubing etc The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in ac cordance with the manufacturer s instructions not regularly maintained used with equipment not approved by HUMAN or used for purposes for which it was not designed HUMAN shall be relieved of any obligation under this warranty unless a completed installation warranty regis tration form is received by HUMAN within 15 days of installation of this pro
59. nt for the selected session is displayed The report can be printed out by pressing the Print button By pressing OK the previous window is dis played CANCEL goes back to the main menu 5 4 2 Patient Cards This voice allows you to display or modify the patient data stored in the database By means of the first window it is possible to display the content of the file and to select the data you are interested in Patients can be deleted from the database by selecting them and pressing on the Delete button New and Modify enter the Patient card window New creates a new patient card in the file Modify allows to modify the stored patient card data Both buttons have access to a window where patient data can be entered This window is similar to the one described in the working ses sion settings paragraph 5 2 3 1 Show reports Patient cards database Int JAMES SMITH Patient card JAMES SMITH 117171337 ou 36 74 User Manual ELISYS 2 PLUS N Human 5 4 3 Notes Hote database x This database contains a number of useful phrases used to comment the medical reports 01 This ig a sentence 02 This other too It uses the same commands and mechanisms Modify outlined previously Delete 5 4 4 Assays This database contains all the necessary infor Zam x mation to run the assays ASSAY As the information contained in this database is of vital importan
60. o leave this value fix on 1 There are different methods called semi quantitative evaluation which use only one known concentration calibrator In this case the sample concentration is calculated as follows sample OD calibrator OD calibrator concentration To execute this calculation the calibrator concentration has to be set in the CUT OFF FACTOR field 24 74 User Manual ELISYS 2 PLUS N Human Calibration curve The last calculated curve is displayed in quan titative methods if there are already previous Assay Toxoplasma IgG standards last run was on 0816 1999 calibration values The curve plotting is specific a ae for each method EE In any case it is possible to 100 1508 change the axes scale a u decide to evaluate the samples based on memorised values keep them or proceed to a 1 Bess new curve calibration execute new 1 000 bs ree 0 800 ie es 0 600 x Linear 0 400 20 40 60 50 100 120 140 160 180 ae Dispense substrates for selected assaysVVash the sample and control filled wells 5 2 3 Sample Setting After the setting of the parameters of each method the window shown allows to couple the samples with the methods This window allows in fact to associate every sample to be analysed with one or more methods present in the selected profile Selecting any Code field of the window it is possible to use the Self increase key to set a predefined p
61. ody is free to move up and down Remove the guidance block see picture with a screwdriver Pull the plunger out of the glass body Replace the tip Disassemble the hole unit Leave the sim program Prime the needle until the tubing system is free of air bubbles See aS eh SS 60 74 User Manual ELISYS 2 PLUS N Human SECTION 7 7 PUTTING THE INSTRUMENT OUT OF SERVICE 7 1 GENERAL WARNINGS have been caused INFECTED CONTAMINATIONS General safety warnings about biological sub The instrument has been used with samples potentially infected urine human sera etc that could stances potentially infected have to be observed Before putting the instrument out of service IT HAS TO BE DISINFECTED see APPENDIX A Before transportation or storage of the instrument draw up the DECONTAMINATION DECLARATION dated and signed by a qualified person 7 2 PUT THE INSTRUMENT OUT OF SERVICE At the end of the instrument operating life dispose of it taking in account the safety for people and environment Unplug the instrument and the PC Disinfect and clean carefully the instrument according to the given instructions see Section 6 and Appendix A Disconnect the inlet outlet tubing as well as the level sensors remove the plastic tanks and clean disinfect them following the above mentioned instructions W X if the instrument has to be transported or stored enclose the Decontamination Declaration dated and
62. otection lid Photometer and Plate washer Needle Work area zer a I fig 2 2 Front view Lid lifted up 8 74 User Manual ELISYS 2 PLUS N Human 2 4 INSTRUMENT MEASURING PRINCIPLE Below fig 2 3 is the diagram representing the main functional elements of the instrument photometric section A monochromatic filtered beam of light produced by a lamp goes through the well containing the sample Part of the light is absorbed by the sample the remaining one is detected by a photodiode The photodiode converts the received light in an electrical signal that is once again transformed into frequency By this frequency the micro processor calculates the absorbance taking in account of the blank measure carried out at the beginning The following is the formula to calculate the absorbance OD Log blank frequency Log sample frequency 1 LAMP 2 LENS LIGHT 3 DIAPHRAGM ee 4 WELL 5 INTERFERENTIAL FILTERS 6 PHOTODIODE gt 2 MEMORY 4 MICRO PROCESSOR RS232 SS 2 INTERFACE ANALOG FREQUENCY me se 715 x 8 gt channels fig 2 3 User Manual ELISYS 2 PLUS 9 74 SECTION 3 3 INSTRUMENT TECHNICAL DATA 3 1 MAIN FEATURES INSTRUMENT AIM ELISYS 2 PLUS is a fully automated analyzer able to carry out up to 8 tests on two microplates SAMPLES Max capacity 40 samples in 16 mm pri
63. pensing a complete strip of conjugate Dispense If it is checked the conjugate will be dispense in the blank well Conjugate in the blank well Dead Volume Remaining volume inside the conjugate bottles Note the parameters can alter the activity program bar the default value are estimated on the base at the machine s overage performance More accurate value can be set up checking the real execution time User Manual ELISYS 2 PLUS 47 74 Substrate ces a T T EEE Note the parameters can alter the activity program bar the default value are estimated on the base at the machine s overage performance More accurate value can be set up checking the real execution time 48 74 User Manual ELISYS 2 PLUS N Human Prediluition Sample Conjugate Substrate A B Stop Read Syringe speeds Hz Yolumes ul Dispensation mode Washing Cycles 1 1 well attime m 1000 I Mi 2wells attime Air bubble I 4wells attime Aspiration fiz V 8 wells attime 1000 Dead Vol ooo Execution time s B2 a Dead Volume Remaining volume inside the stop solution bottles Execution Time Execution time to dispensing a complete strip of stop solution User Manual ELISYS 2 PLUS 49 74 Read eat Reading Waiting time of the reader to perform the absorbance s reader delay time 50 74 User Manual ELISYS 2 PLUS N Human 5 6 RACK ARRANGEMENTS
64. ples dispensation is in double mode it is carried out with two single moves The suck up syringe speed is SV250 the dispensation speed SV2500 The blank wells are left empty Conjuga3 ap2 dispensation volume 200 ul e The Conjugate dispensation on the blank wells is not carried out e The suck up syringe speed is SV1000 the Conjugate dispensation is carried out with two moves the dis pensation speed is SV3000 Chromoge3 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Chromogen dispensation is carried out with two moves the dis pensation speed is SV3000 Stop2 ap2 dispensation volume 50 ul e The syringe suck up speed is SV1000 the Stop Solution dispensation is carried out with just one move the dispensation speed is SV2500 GROUP No 131 Universal Group 70 74 User Manual ELISYS 2 PLUS N Human APPENDIX F ON LINE MODULE The function of this interface is to allow the user to import a working list from a remote computer and to transform the related data into an exportable format The communication link between the host and the client s PC is established through the following files e INPUT Text file that includes the work list with WLT extension e OUTPUT Text file that includes all session results with LAB extension After importing the work list from the WLT file and carrying out the analysis session the software automatically generates an output file with a LAB extension that contains
65. r a single dispensation of sample Mode The sample will be dispense together with conjugate the first incubation time will be automatically zero Dead Control Vol Remaining volume inside the control vials Dead Standard Vol Remaining volume inside the calibrator vials Note the parameters can alter the activity program bar the default value are estimated on the base at the machine s overage performance More accurate value can be set up checking the real execution time 46 74 User Manual ELISYS 2 PLUS N Human Conjugate Prediluition Sample Conjugate Substrate A B Stop Read Marne zZ Dispense conjugate in the blank well po speeds Hz Volumes Hi Dispensation mode Washing 1000 I Air bubble Tt 1 well attire Cycles Dispensing o Aspiration 1 000 T 2Zwells attime Tt 4wells attime Dead ol 2000 Wi wells attime Execution time 5 34 ee Conjugate Dispensing Syringe speed for conjugate dispensation Aspirating Syringe speed for conjugate aspiration Washing Volume of liquid for the cycle washing and number of wash cycles between samples Air bubble Volume of air bubble Dispensation Dispensation mode for the conjugate 1 well at time Dispensation mode for the conjugate 4 well at time Mode Dispensation mode for the conjugate 2 well at time Dispensation mode for the conjugate 8 well at time Execution Mode Execution time to dis
66. s carried out with just one move the dispensation speed is SV2500 User Manual ELISYS 2 PLUS 69 74 GROUP No 5 Used for HbsAg Anti HBs anti HbcAG PrediluS ap2 e This group does not involve the sample predilution Sample5 ap2 dispensation volume 50 ul 50 ul of Conjugate e f the controls or standards and samples dispensation is in double mode it is carried out with two single movements The sucking up syringe speed is SV250 the dispensation speed is SV2500 The blank wells are left empty e The Conjugate is immediately carried out the Conjugate dispensation onto the blank wells is not carried out The syringe suck up aspiration is SV1000 the Conjugate dispensation is carried out with just one move the dispensation speed is SV3000 Conjuga35 ap2 e The file is empty dispensation already carried out immediately after the controls Chromoge5 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 The Chromogen suck up is carried out with just one move The dis pensation speed is SV3000 Stop5 ap2 dispensation volume 100 ul e The syringe suck up speed is SV1000 the Stop Solution dispensation is carried out with just one move the dispensation speed is SV2500 GROUP No 20 Used for Testosteron Cortisol Progesteron E2 FE3 DHEAS Predilu3 ap2 e This group does not involve the sample predilution Sample3 ap2 dispensation volume from 25 ul to 50 ul e f the controls or standards and sam
67. signed by a qualified operator 7 2 1 Momentary Stocking Deactivate the instrument and label it with warning signals of OUT OF SERVICE OUT OF SERVICE INSTRUMENT The instrument was used with Biological substances potentially infected AN DECONTAMINATED INSTRUMENT User Manual ELISYS 2 PLUS 61 74 7 3 INSTRUMENT TRANSPORT AND HANDLING The instrument is packed with a plywood box which can be easily moved by a lifting trolley Be careful when placing the instrument onto the work area The safety warnings and general rules have to be observed when moving or lifting the instrument INSTRUMENT WEIGHT 80 Kg PACKED INSTRUMENT WEIGHT 100 Kg W When shipped or transported the instrument has to be provided with DECONTAMINATION DECLARATION see Appendix A of this manual 7 4 INSTRUMENT STORAGE Before storing the instrument for a long time pack it carefully as described above Relative humidity has to be less than 85 and temperature between 10 C and 60 C W When stored the instrument has to be provided with DECONTAMINATION DECLARATION see Ap pendix A of this manual 62 74 User Manual ELISYS 2 PLUS N Human APPENDIX A INSTRUMENT DECONTAMINATION The instrument involves the handling of samples which can be infected urine and human serum and positive controls In this condition INFECTIONS or CONTAMINATION might occur Every part and accessory of the instrument must be considered potentia
68. soft Windows 95 or 98 for Microsoft Windows 98 Il Edition you need the BDE Installer version 1 0 15 MB free on hard disk 1 44Mb floppy driver RAM 32 Mb Pentium or compatible processor at 166 MHz Display adapter standard VGA 640x480 Printer The described features can be altered at the producer s discretion without forewarning 12 74 User Manual ELISYS 2 PLUS N Human SECTION 4 4 INSTALLATION AND START UP INSTRUCTIONS must be observed A Installing and setting up the instrument the safety warnings and general rules described in Section 1 Warning when moving or lifting the instrument consider e INSTRUMENT WEIGHT 80 Kg e PACKED INSTRUMENT WEIGHT 100 Kg 4 1 UNPACKING The instrument is packed with a plywood box which can be easily moved by a lifting trolley Be careful when placing the instrument onto the work area To unpack the instrument follow the instructions as below described Remove the packaging band around the plywood box Lift the plywood box straight up from the bottom plate and place it beside the instrument Remove the packaging band and the protective plastic sheets around the instrument Unscrew the four 10 MA screws fixing the instrument body to the bottom plate of the box Save the empty box and the fixing screws for future transportation W X If the instrument was already in use check for the DECONTAMINATION DECLARATION see Appendix A of this manual W PLEASE SAVE THE EM
69. t the samples sera as shown below OY w Previous Ok Cancel Help Run analysis m Predilution cups BLOCK 1 1 1 0 0 0 0 0 aC BORO BEES 2 While analysis are being carried out the window will show a Pause button to interrupt the process a window box to display the errors during the process the most common liquid not found two indicators showing the passed minutes and the remaining time to the end of the work Session 32 74 User Manual ELISYS 2 PLUS 5 3 4 Displaying the Results and Their Acceptance Evaluation The results are shown at the end of the analy sis process For each method there appear two windows On the first page the values of the blank are reproduced They can be excluded from the evaluation removing the selection in the corre sponding control box Also the standard values can be excluded from the calculation by marking the corresponding checkbox On duplicate determination it is possible to exclude only one value by marking the corresponding value directly If the method has been executed in quantita tive evaluation the calibrator results are shown too In this case it is possible to visualise the curve corresponding to the results pressing on the box Draw curve If you press the Next key the second window is shown where th
70. te 1 User Manual ELISYS 2 PLUS 25 74 Note 1 The session is automatically divided in various runs if the total sample dispensation time is longer than the sample incubation time of the first method The program advises the user and disables the selection if the maximum of the pre dilution cups 40 or the strips 24 is reached Ap x Ap rf d S Error i t Ine Tumsa oi Utetalulets sel alles le ela lerre There are no more free dilution cups to dilute this sample Clicking on OK the session is memorised with the actual settings Clicking on Run the working session begins to run Note 2 See Par 5 3 5 2 4 Single Step Operation To run an assay in a sequence of distinct phases or just a specific phase select Single steps under the item Session of the main menu A window will appear for the assay set up similar to that of par 3 2 3 but with three additional buttons to allow the selection of the desired phases in single steps In this mode of operation after each phase steps the machine stops waiting the command to go on to the following phase step Session setup Self ncrease Patient card BA A c Code ES a p Single steps 1 PATIENTON gt Ed Y Fr Dispense 2 PATIENTO gt fw Y fr Wash 3 Fr A OO OF need s PATENTO A FO OF anent M Ww WF er e Parente 7 w m z Pamen eo Po F a Pamenta PR OR a Paten Po Bor 1O PATIENTIO WM I IF I Pe Pe 53 Full strips
71. the end of a work session or for scheduled maintenance the instrument requires a washing cycle In this case Reader Washer Group OODODODOODOOOOG CODDODDODOOOO 000000000000 OGCOOGOOOGOOO 000000000000 000000000000 000000000000 OCOGOOOOGOGOO OODGOGOOSGHGA COGOOOGGODdOO OO DODOAHOAGSGG 000000000000 O 000000000000 COCOCCOOCOOCO OO OOOHOSGOOSAGG EOO0000000000 Predilution ODOOOD plates 1 11 2131 eee 2 1 a lolololololololo IQ ON O0I00I00 00 00 00 00 00 7 DOOD o0ol0o0 l00 00 00 00J00 00 Hess O 00 00 00 00 00 00 00 00 FF oo oes Substrate Reagents Stop solution Cleaner trays fig 4 3 a fig 4 3 b 16 74 User Manual ELISYS 2 PLUS N Human 4 5 1 Samples Tray The sample tray is a support for sample vials primary tubes to be analysed The tray may be for 60 primary tubes sized 10 12 mm in diameter and 100 mm in height optional or 40 pri mary tubes sized 14 16 mm in diameter and 100 mm in height Vials are manually loaded according to the program instructions See paragraph 5 3 4 5 2 Trays for Reagents and Controls Different types of reagent trays may contain dilution solutions substrate stopping solution cleaner conjugate calibrators and controls Part of th
72. ue leGileM Heli pylori lele A 17301754 RACE 5 RACE 7 Bu Og 00 17301757 17301793 17301756 HORMONES HIV HCY AND HEY 17301760 UNIVERSAL COMMON RACK INFECTIOUS DESEASES 1301 59 INL 1 El used with RACK 2 RACK 3 RACK 4 RACK used writ RAC Tot IgE 17S01 89 free format COMBION RACK UNIVERSAL 17301790 used with RACK 6 RACE T free format The Racks are optinuzed for Human Tests Rack 6 is a free format Rack and has removable nings to fit different bottle sizes HUMAN Methods Methods can be executed together combined within one session 66 74 User Manual ELISYS 2 PLUS N Human APPENDIX D GROUP RACK BLOCK DIVISION TEST GROUP PAR RACK TYPE BLOCKN CMV IgG IgM Measles Virus IgG IgM Mumps Virus IgG IgM Rubella IgG IgM Toxoplasma IgG IgM Varicella IgG IgM ee et a MaA ee e a MaA oe aa MaA WWWWWWW WW W Testosteron Cortisol Progesteron E2 5 5 5 5 5 5 5 5 5 5 7 T 7 T T 7 5 5 WWWWWWWWWWWW WW WWW W anti HbcAg anti HCV A 3 3 HIV 1 2 2 4 5 Helicobacter IgG IgA 1 1 1 Dengue IgG IgM 1 1 1 Note Bordered methods can be combined within on session User Manual ELISYS 2 PLUS 67 74 APPENDIX E DEFINITIONS FOR GROUPS GROUP No 1 Used for CMV IgG CMV IgM EBV IgM EBV IgG HSV1 IgG HSV2 IgG HSV IgM Measles IgG Measles IgM Mumps IgG Mumps IgM
73. ved and using the original spare parts Y Alterations of the instrument are prohibited The user is liable for any instrument improper modi fication as well as the deriving consequences Should the instrument need extraordinary maintenance ask for Human Service or for licensed service centres The maintenance will be carried out by Specialised Technicians that will be able to fix the instrument using the original spare parts to replace the defective ones 6 74 User Manual ELISYS 2 PLUS N Human SECTION 2 2 GENERAL INFORMATION 2 1 INSTRUMENT DESCRIPTION PURPOSE AND FEATURES ELISYS 2 Plus fig 2 1 is an automated instrument designed to carry out tests on microplates by optical density reading It is able to mix organic samples by pre diluting them if necessary with reagents and to process up to 2 plates on line fig 2 1 2 2 MANUFACTURER S IDENTIFICATION LABEL Made in EC Manufactured for HUMAN GmbH Germany APPAR ELISYS 2 17300 Cat No SERIAL N FABRICATED User Manual ELISYS 2 PLUS 7 74 2 3 INSTRUMENT DESCRIPTION The instrument that is shown in figure 2 2 is composed of Instrument framework and protection lid Control system run by electronic parts Aspirating and dispensing system Mechanical arm carrying a dispensing needle Movable photometer and plate washer Work area with two microplate places a washing basin reagent trays a tray for samples and two predilution plates Pr
74. volume of 1 ml Minimised to less than 3 by washing the pipetting system after each single sample dispensing and after each reagent dispensation phase Sample and reagent levels are sensed by the needle used as a Capacitive sensor Less than 150 ul Between 100 ul and 400 ul depending on the bottles used 8 channel moving manifold with separate filling and aspiration ports 2 different washing solution to choosing from within a work session External and internal washing About 10 of reagent aspirated for all the assays used for cleaning the sampling system two 2 liter bottles a S liter bottle a 10 liter tank Each one is equipped with a level switch to check whether the tank is full or empty At room temperature Ta or programmable from Ta 5 C up to 45 C in steps of 1 C PHOTOMETER Light source Filters Detectors Measurement range Accuracy from 0 000 to 1 500 O D from 1 500 to 3 000 O D Stability short term Moving 8 channel device with automatic blanking and internal calibration Tungsten lamps 2 standard interferential filters 450 and 630 nm bandwidth 8 nm Other wavelength values on request Two more optional filters to be added Silicon photodiodes 0 000 3 000 O D Optical Density 1 or 0 010 O D whichever the bigger 2 0 001 O D in 1 minute User Manual ELISYS 2 PLUS 11 74 INSTRUMENT TECHNICAL SPECIFICATIONS Continued SERIAL INT
75. xes must at least be filled in Pa tient ID Group Name Birth day Sample date e Time Sample date Time Patient s information already stored in the Help database can be accessed by clicking on the DataBase button and by selecting the patient s name amongst the ones present in the file The card can also be filled in and the infor Ligue Sieo mation registered in the data base This al Group Mame lows to memorise the information of patients which have to be checked often In this case the program asks which opera tion to carry out what do you want to do Save the current patient s data in the archive Delete the current patient s data and pick one from the archive More information about the patient chosen can be inserted by using the button More Notes Database There can be inserted up to 5 additional comments In this case the DataBase button can also be used proceeding equally as explained previ ously Cancel Help User Manual ELISYS 2 PLUS 29 74 5 3 RUN ANAL WORK AREA PREPARATION Par 5 3 2 ANALYSIS EXECUTION Par 5 3 3 YSIS T 1 Microplate composition 5 2 Common reagents 4 3 a 3 b Tey 4 3 a Specific reagents for assay A WORK AREA PREPARATION next 3 b Specific reagents for assay B 4 Sample sera Start analysis 5 Dilution cups

User Manual - Frank`s Hospital Workshop

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