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User Manual - Frank`s Hospital Workshop

1. Q u SEGA 88 RR OIONOJIO lO OT ON O as QO OOJOOCJOOIOOCIJOOIOOIOOIJOO 1 9990 00 00 00 00 00 00 00 00 dosso Q oolocloc oo ooloc oo 00 v ile i Samples ilution ubstrate eagents di solution i trays Cleaner fig 4 3 a fig 4 3 b 18 75 User Manual ELISYS 2 Rev 6 4 5 1 4 5 2 4 5 3 4 5 4 4 5 5 4 5 6 Ss Human 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 primary 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 Trays for Reagents and Controls Different types of reagent trays may contain dilution solutions substrate stopping solution cleaner conjugate calibrators and controls Part of them 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 according to the given program instructions see paragraph 5 3 for the specific assay method Pre dilution Plate The pre dilution plate is a molded 20 wells plastic container The needle dispenses the sample along with dilution solution into each cup according to
2. 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 User Manual ELISYS 2 Rev 6 55 75 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 password 5 7 1 Breakonerror 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 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 line BreakOnError 0 In case of a low or missing reagent sample the ELISYS2 c
3. 1 Activate microplate s Selecting this item the machine will execute the nn activation of the microplate s respecting the Oh 0 0 f previously set time 2 Wash sample and control wells Selecting this item the machine will execute the first washing cycle respecting the previously set Oh 15 24 time 3 Wash conjugate wells Selecting this item the machine will execute the Oh 12 39 ca washing cycle respecting the previously set Session setup Self increase SER nel Cotone Patient card B A G Code Ez 4j al Single steps 1 PATIENTO Vv Vv Vv Dispense 2 Patent gt W Vv Vv Wash 3 Parents gt m v aa Read microplate s Oh 18 30 4 PATIENTO gt m Vv Vv 5 Patents gt W Vv Vv Sia 6 Patents gt W Vv Vv 7 PATIENTO gt W Vv Vv Run later 8 Patente gt m Vv Vv Cancel 3 PATIENTOS gt W Vv Vv Cance 10 PATIENTIO gt m d d jel Usedwelss 53 53 53 Full strips 21724 44 47 to dispense sera EEE EEE ESSER EEE RRR Read Pressing this button the following menu appears 1 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 30 75 User Manual ELISYS 2 Rev 6 5 2 5 Entering the Patient Card It is possible to couple each sample to a patient report s
4. 2 level maintenance operations Period service level Replacing internal connecting tubing 12 months Replacing peristaltic pump tubing 3 months Replacing Lamps 12 months that is 500 hours Cleaning the optical group lenses 9 months Internal cleaning of the washer group 6 months 6 2 Cleaning the Instrument s Parts WS i c S Warning cleaning the instrument do not use alcohol or similar solutions A use of 0 5 sodium hypochlorite solution is recommended When cleaning don t let electric parts connectors etc get wet if necessary before turning on the instrument dry them out After each work session clean disinfect the instrument carefully Use a water soaked cloth or light detergent to clean the instrument external parts To clean 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 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
5. Quantitative parameters 14 15 1 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 dilution 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 40 75 User Manual ELISYS 2 Rev 6 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 already defined parameters typical for that group Note in Appendix 1 to this document the Groups already defined are listed 3 Rack type Identifies by a numeric code the types of racks specific and common to be used for the method Se Note if the Universal racks are used set to 6 the rack type code 4 Name Field to be filled with the name of the assay to be set 5 Dilution Serum volume quantity of aspirated sample in pl Dilution volume quantity of aspirated dilution
6. 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 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 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 predefinitions appears in the reagent name compartment in the assay parameter settings section Session Databases Settings Commands About mE lS Lab name z E E al E Doctor name Dilution Names Buffer Names Serial port Password Ext incubation 58 75 User Manual ELISYS 2 Rev 6 Ss Human 5 8 Commands Session Databases Settings Commands Help rr Prime needle il R WN Prime washer Wash MicroPlate Aspirate MicroPlate Temperature inspection Movements test This menu contains a series of commands for simple operations and diagnostic instruments to check the function of the instrument The first set of commands cont
7. 3 4 CALIBRATION CURVE for quantitative analysis only Accept or Reject ACCEPT 2 REJECT STORE RESULTS REJECT RESULTS ACCEPT REJECT RESULTS Par 5 3 4 Last assay Go to the next assay NO 7 YES o LAB PRINT 0 EM P PATIENT PATIENT 01 REPORT next gt PATIENT REPORT PRINT REPORTS Par 5 3 5 Ea Vv Go back to the MAIN MENU Par 5 1 Table 5 4 Run assays sequence 32 75 User Manual ELISYS 2 Rev 6 N Human 5 3 1 Run the Process 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 vi Microplate composition 5 3 2 1 Microplate composition i een aeg 1023040506 70 8910 12 The first window shown is a summary of the rn essesssaees set methods and an overview of the 7 100 00 0 0000 0000000000 composition of the microplates D 6060080000000 D OOOOO E 9008 0000000 EOOOOOOOOOOOD It shows the strips used for each method and F 00 0CC0O000 FOOOOOOOOOOOO in which execution they are carried out 5 BELLO LVL n BRL LL Prior the test performance the strips always Strip 1 2 3 4 5 6 7 8 9101112 1314151617 1819 20 21 22 23 24 have to be filled up It must be guaranteed HH AFP_strips1 2 runt HI Neutral wells that all positio
8. 5 3 Pre dilution Plate 19 4 5 4 Microplate 19 4 5 5 Wash Basin for the Needle 19 4 5 6 Reader Washer Group 19 4 6 Elisys 2 PC Connection 20 4 7 Software Installation on PC 20 4 7 1 PC Minimum Requirements 20 4 7 2 Software Installation 20 SECTION 5 21 OPERATING INSTRUCTIONS 21 5 1 Introduction 21 5 1 1 Operating Overview 21 5 1 2 Powering the Instrument 22 5 1 3 PC program starting 22 5 1 4 Operating Menu 22 5 2 Work Session Setup 24 5 2 1 Select Profile 25 5 2 2 Set Parameters 26 5 2 3 Sample Setting 27 5 2 4 Single Step Operation 28 5 2 5 Entering the Patient Card 31 5 3 Run Analysis 32 5 3 1 Run the Process 33 5 3 2 Work Area Preparation 33 5 3 3 Analysis Execution Running Phase 34 5 3 4 Displaying the Results and their Acceptance Evaluation 35 5 3 5 Patient Reports 36 5 4 Databases 37 5 4 1 Medical reports 37 5 4 2 Patient Cards 38 5 4 3 Notes 39 5 4 4 Assays 39 User Manual ELISYS 2 Rev 6 3 75 5 5 Assay Parameter Setup 5 5 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 5 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 Dilutio
9. PARAMETERS eee lt gt m Pa 522 page 1 4 v SAMPLE SANPLE SETTING gt PATIENT CARD dad gt PATIENT DATABASE SETTING Pa 523 ED RUNANALYSS Ci 1 Maroplate n to locate microplates into their own E 2 Commo reagents tolocate reagents on the common z Ro a 4 3 a Specific reagents for assay tolocate controls and calibrators assay WORK AREA i i i MEU PREPARATIN 3b Specific reagents for assay tolocate controls and cdibrators assay EF next Pa 532 4 Sanplesera tolocatethe samples into the 5 Dilution cups Prime tolocate the predilution rs No Dont forget locate the weshing sdution a locate the wesh buffert buffe2 YES locate the weste Tank level make sure they have been make sure it is empty ANALYSIS Prime execution EXECUTION 4 Time flaw for every operation Pa 533 WAS EXECUTION Sessionend remaining time zus Errors in process liquid not found D D er Y a Acougle of windows A BLANK A CONTROLS zara DISPLAY EVALUATE STANDARD VALUES gt i a RESULTS next previous A Pa 534 CALIBRATION CURVE acon j ACCEPT Popek or Bejat REJECT Vv STORE RESULTS REJECTRESULTS ACCEPT REJECT RESULTS Pa 534 L tothe next assay N0 lat ci YES Jo LABPRINT le Bm er dA PATIENT ENDET PATIENT REPORT REPORTS cal lt gt PRINT Pa 535 Ce v Go back tothe WANE Pasi OPERATING FLOW DIAGRAM User Manual ELISYS 2 Rev 6 75 75 Human Gesellschaft fur Biochemica und Diagnostica mbH Max Planck
10. aj i Single steps 1 JPATIENTOT gt Iv Vv Vv Dispense 2 PATENT Ww o F via sans WK w gt 4 FATIENTO4 gt W Vv Vv o 5 PATIENTS MW WwW M Run 6 FATIENTO6 gt W d d 7 PATENTO gt W Vv Vv s Parents WV KW WF sfata PO F tere 10 PATIENTIO gt m Vv Vv Help Used wells 53 53 53 Full strips 21724 PETTITT TTT TET Ty 44 47 to dispense sera EE EERE EERE ERRRRE SERRE RRR 28 75 User Manual ELISYS 2 Rev 6 Ss Human Session setup Self increase Si Ate Patient card B A C Code 4l lj Single steps 1 PATIENTO gt W Vv Vv Sample predilutions Oh16 53 f Samples and controls Oh 44 47 2 PATIENTO2 gt v M v Conjugatels Oh 12 37 3 PATIENTO3 gt n Iv IV Substrate s Oh 12 39 Stop solution s Oh 12 32 4 PATIENTO gt m Vv Vv 5 Patents gt m Vv Vv Run 6 Patente gt W Vv Iv 7 FATIENTO M Vv Vv Run later 8 FATIENTO8 gt m Vv Vv Cancel 9 PATIENTOS gt W Vv Vv 10 PATIENTIO gt W Vv Vv Jelp Used wells 53 53 53 Full strips 21 24 PTT TTT TTT TTT iii iii ii ey 44 47 to dispense sera PEER ERRRERRERRRRRRRRRRRR RRR Dispense Pressing this button the following menu appears 1 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 exec
11. ap2 dispensation volume 501 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 1001 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 100pl 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 1001 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 100pl 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 5 Used for HbsAg Anti HBs anti HbcAG User Manual ELISYS 2 Rev 6 71 75 Predilu5 ap2 e This group does not involve the sample predilution Sample5 ap2 dispensation volume 50ul 50ul of Conjugate e f the controls or standards and samples disp
12. both the photometric reading and the microplates washing in succession according to the program User Manual ELISYS 2 Rev 6 19 75 4 6 4 7 4 7 1 4 7 2 Elisys 2 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 with two 9 pin connectors female male is supplied with the instrument An adapter 9 25 pin may be necessary on the PC side connection i k Tx Rx DTR GND RTS NAIA ON Fig 4 4 RS232 serial port located at the instrument right side Software Installation on PC 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 Software Installation AP 2 is the program specifically developed for ELISYS 2 To install AP 2 program on the PC place ELISYS 2 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
13. 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 maintenance operator s availability For accurate installation 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 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 i
14. has to he placed always on the right side of the working area to cover position 7 and 8 The universal reagent racks are to be placed on the following positions from 6 up to 1 a maximum number of 6 universal reagent racks can be positioned CELELALTE VO O III OO OO oe OR ORO DEI FORD LITI HOOK OV OV IOY JOY OY O A 1 2 3 4 5 6 2 Samples Rack Reagents Rack Common Rack U niversal U niversal 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 positioned according to the needs CRRA O OO O O QQ OSO OROCO 2 LEHI O 9S9 IEAS srerore 00 0 60 OIRO IOD lac Or IS IS Ce OOOO one fA__ 1 2 3 4 5 6 7 8 Samples Rack Common Rack AG Rack Morgen Rack Common Rack tandard Universa U niversal Fig 5 Note 1 The position of the two common racks is fixed and not interchangeable universal common racks always on the ri
15. real execution time 48 75 User Manual ELISYS 2 Rev 6 zz Human Conjugate ni ni ni xI 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 mode for the conjugate 1 well at time Dispensation Dispensation mode for the conjugate 2 well at time Mode Dispensation mode for the conjugate 4 well at time Dispensation mode for the conjugate 8 well at time Execution Mode Execution time to dispensing 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 Rev 6 49 75 Substrate fw g e CI Substrate A B Dispensing Syringe speed for substrate dispensation Aspiration Syringe speed for substrate aspiration Washing Volume of liquid for the cycle washing Cycles Number of wash cycles between samples Air bubble Volume of air bubble Dead Volume Remaining volume inside th
16. result print and file the results e memorise the calibration curves 12 75 User Manual ELISYS 2 Rev 6 3 2 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 pl 10 ul Better than 1 at a volume of 100 pl 35 minutes for 96 wells for a washing volume of 1 ml 7 minutes for 96 wells for a washing volume of 1 ml Minimi
17. 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 e setup the requested analysis and to process on line different methods give to the instrument the relevant commands e receive and transfer the analysis
18. Assay ll If the method has been executed in quantitative evaluation the calibrator results are shown too Note Whenever a double dispensation is chosen the display shows the two measured absorbances their average and CV 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 the results of the set controls are visualised it 18 possible to exclude the obtained values removing the selection in the showthe contils and ouves _ control fields located on their left Assay EBV IgG Controls iW Negative 0 048 MEAN 0 058 CV 16 5 MW 0 067 Depending on the values displayed 1M Positive 0 053 MEAN 0 047 CV 128 3 Sigs 5 Vv 0 041 and which might have been modified it is possible to accept or reject the results of the examined method T rr pressing the buttons Equivocal zone 0 053 0 072 Accept assay or Reject assay Previous Roa Reject assay Accept assay NOTE 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 analysis the OK button is not active until all the methods have been accepted User Manual ELISYS 2 Rev 6 35 75 5 3 5 Patient Reports In the Show the results panel appear
19. 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 14 75 User Manual ELISYS 2 Rev 6 N Human SECTION 4 INSTALLATION AND START UP INSTRUCTIONS IN Installing and setting up the instrument the safety warnings and general rules described in Section 1 must be observed A 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 G A If the instrument was already in use check for the DECONTAMINATION DECLARATION see Appendix A of this manual CI O PLEASE SAVE THE EMPTY BOX This box is designed and manufa
20. Front view Lid lifted up 10 75 User Manual ELISYS 2 Rev 6 Ss 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 microprocessor 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 naso ae i Se he a i 2 LENS LIGHT 3 DIAPHRAGM SOURCE sca 1 4 WELL 5 INTERFERENTIAL FILTERS 6 PHOTODIODE i 2 MEMORY 4 MICRO PROCESSOR RS232 Ce 2 INTERFACE Fe FREQUENCY i era CHR Js CMe AMPLIFIER qd 6 EXTERNAL PC channels fig 2 3 User Manual ELISYS 2 Rev 6 11 75 SECTION 3 INSTRUMENT TECHNICAL DATA 3 1 Main Features INSTRUMENT AIM ELISYS 2 is a fully automated analyzer able to carry out up to 8 tests on two microplates SAMPLES Max capacity 40 samples in 16 mm primary tubes or 60 samples in
21. L POWER REQUIREMENT Standard 220 or 110 Vac 50 60 Hz POWER CONSUMPTION 500 W Max OPERATING CONDITIONS Temperature from 15 C to 30 C Relative Humidity up to 80 SHELF CONDITIONS Temperature from 10 C up to 60 C Relative Humidity up to 85 DIMENSIONS Width 790 mm Height 595 mm 980 mm with lifted up lid Depth 600 mm 650 mm with lifted up lid WEIGHT Instrument 72 Kg Packed instrument 97 Kg wooden box dimensions 89x68x75 cm EUROPEAN REFERENCE DIRECTIVES 73 23 EEC regarding low voltage electrical material 89 336 EEC regarding Electromagnetic Compatibility 93 68 EEC regarding the CE mark HARMONIZED STANDARD Safety SPECIFICATIONS 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 INSTRUMENT OUTFIT 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 PC optional supply The PC minimum requirements are e Microsoft Windows 95 or 98 for Microsoft Windows 98 Il Edition you need the
22. Quantitative assay parameters FSH button it is 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 Paint to Point 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 5 4 4 1 Note 2 Remember the drawing of the Log logit curve requires at least four calibration points but for the other types of curves only two of them are needed s dii P je A E pezzi ser E User Manual ELISYS 2 Rev 6 43 75 CURVE Point to point CURVE Linear regression CURVE Log logit polynomial regression Calibration plot 44 75 User Manual ELISYS 2 Rev 6 N Human The Qualitative parameters button shows the parameter setting window for saan z this type of analysis SREE Control check gr lumber of e re From this window for each method it is oe O possible to an z DE 0 3 insert the control names used by the Negative method Names selecting them from Fosive E ie the present ones in the list or writing Positivity condition them directly into the box ee SE set the acceptance control condition rg Control check up to a maximum of four cond
23. 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 06 2004 04
24. S lt gt Vor antats esse on Par 5 2 2 page 1 4 SAMPLE SETTING SAMPLE SETTING lt gt PATIENT CARD Par 5 2 3 o Par 5 2 3 1 os PATIENT DATABASE Vv RUN ANALYSIS Par 5 3 Table 5 3 Session set up 24 75 User Manual ELISYS 2 Rev 6 5 2 1 N Human 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 when the same type of analysis is run frequently Select profile x Assay 1 CMY IgM hd r Sample rack Assay 2 YP TE isd 40 samples Assay 3 60 samples Select profile Assay 4 Assay 5 OK Assay 7 Cancel Assay 8 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 it is not possible to process different sets of methods at the same time in the following situations more than two washing solutions more than two dil
25. User Manual ELISYS 2 N Human REVISION LIST OF THE MANUAL DATE Rev REVISION DESCRIPTION 0 fewn Preliminayisue CS 2 000915 NEW Spare Parts Page 55 ET ee 3 000921 NEW External Incubation Page 45 O LT Denn 4 000925 CHANGE Maintenance Page 46 NEW Change syringe tip Page 48 CHANGE Decontamination procedure Page 47 5 020423 NEW Software Version 3 28 en CHANGE Spare Parts Consumables Page 68 030217 NEW Integration of new ELISA Tests Hel ll il 1 os 1 fede _ ________FrAAan i e E ed et tTT oeLqNgRg yo 1 uri e _ aa User Manual ELISYS 2 Rev 6 1 75 This side left blank 2 75 User Manual ELISYS 2 Rev 6 N Human CONTENTS INTRODUCTION 5 0 1 Description 5 0 2 User Warranty 5 SECTION 1 7 GENERAL SAFETY WARNINGS 7 1 1 Danger Warning Symbols 7 1 2 Intended Use of the Instrument 7 1 3 Use of the Instrument 8 SECTION 2 9 GENERAL INFORMATION 9 2 1 Instrument Description Purpose and Features 9 2 2 Manufacturer s Identification Label 9 2 3 Instrument Description 10 2 4 Instrument Measuring Principle 11 SECTION 3 12 INSTRUMENT TECHNICAL DATA 12 3 1 Main Features 12 3 2 Instrument Technical Specifications 13 SECTION 4 15 INSTALLATION AND START UP INSTRUCTIONS 15 4 1 Unpacking 15 4 2 Placing the Instrument 16 4 3 Power Supply 16 4 4 Wash And Waste Container Installation 17 4 5 Work Area 18 4 5 1 Samples Tray 19 4 5 2 Trays for Reagents and Controls 19 4
26. 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 sample lt OD cut off X gt positive OD sampie gt OD cut off tX gt negative Note 3 x represents the equivocal zone User Manual ELISYS 2 Rev 6 45 75 Cut off calculation Examples Example 1 cut off NC PC 2 1 Having 3 controls NC PC HC supposing to calculate the Cut off according to the optical density values average of the negative and positive controls Considering that formula 1 can be written as following comparing this formula with the general one provided by the instrument it is possible to calculate the cut off value as required by the method assigning to the coefficients a b and c the following 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 NC negative control PC positive control HC high positive control cut off NC 2 PC 2 cut off a x C1 bx C2 c 2 a 0 5 b 0 5 c 0 Example 2 cut off NC K x 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 posit
27. abase contains all the necessary information to run the assays As the information contained in this database is of vital importance for the correct functioning of the instrument this file is protected by a password The access is only recommended to the personnel with a thorough knowledge of the Assay database Ea ASSAY functioning of the program and the see instrument Once the password has been entered selection window of the assays is displayed Measles Virus IgG Cx New allows to add assays ee a Copy can be used to copy settings from the selected tests into a new a one The name of the new test has to be different from the source W It is recommended NOT to modify any setting if you do not have a sufficient knowledge of the functioning of the program and the instrument Save allows too store the selected test On a floppy disk or in a different directory on the 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 related to the selected tests User Manual ELISYS 2 Rev 6 39 75 5 5 Assay Parameter Setup This window allow to set the parameters of a new method Assay parameter settings Name EBV IgG 4 Blo Volumes Hl tanding time or solution I Empty wells atthe end
28. ains 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 thermo regulation 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 Rev 6 59 75 SECTION 6 MAINTENANCE Only qualified personnel is entitled to carry out maintenance see Section 1 of this manual Carrying out the maintenance operations follow the general 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 op
29. are to be compatible with the block number characteristics 9 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 different 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 10 Filters 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 11 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 12 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 13 Notes 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 17 42 75 User Manual ELISYS 2 Rev 6 Human Using the Quantitative parameters
30. ck 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 10011 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 Chromoge1 ap2 dispensation volume 100 1 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 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 20ul of sample 100ul 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 The 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 1 e A
31. ctured for this instrument only and should be used in future transportation User Manual ELISYS 2 Rev 6 15 75 4 2 4 3 WG W 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 sunshine 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 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 Warning make sure that the fuses value corresponds to the one indicated beside the fuse holder 220 Vac mains 2 quick fuses 3 5A 110 Vac mains 2 quickfuses 7A 16 75 User Manual ELISYS 2 Rev 6 rs Human 4 4 Wash And Waste Container Installation In figure 4 2 are shown the washing discharging containers and their connections with the instrument Wash Wash buffer 1 buffer 2 A II Blank WASH Wash Wash WASTE buffer buffer 1 2 T3 T1 T2 T4 S Precision Syringe A Peristaltic Pump for need
32. e 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 r Lot Assay FSH Lot Pag 1 2 Repetitions Expiration nni Curve C Single Cut Off facto ff Duplicate Controls Samples Single Bu W Begin Duplicate I End Controls Singh lai T Every samples Duplicate ae Sine Blank No r Execution mode Single C Qualitative Duplicate Quantitative Cancel Note 3 Cut Off factor field For most ofthe methods executed in qualitative evaluation it is necessary to 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 26 75 User Manual ELISYS 2 Rev 6 5 2 3 YN Human Calibration curve The last calculated curve is displayed Bis in quantitative methods if there are already previous calibration values The curve plotting is
33. e instrument has been used with samples potentially infected urine human sera etc that could have been caused INFECTED CONTAMINATIONS General safety warnings about biological substances 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 Putthe 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 e if the instrument has to be transported or stored enclose the Decontamination Declaration dated and 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 Rev 6 63 75 7 3 WW 7 4 W Instrument Transport and Handling The instrument is packed with a ply
34. e substrate bottles Dispensation mode for the substrate 1 well at time Dispensation Dispensation mode for the substrate 2 well at time Mode Dispensation mode for the substrate 4 well at time Dispensation mode for the substrate 8 well at time Execution Time Execution time to dispensing a complete strip of substrate 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 50 75 User Manual ELISYS 2 Rev 6 YN Human Stop Stop Dispensing Syringe speed for stop solution dispensation Aspiration Syringe speed for stop solution aspiration Washing Volume of liquid for the cycle washing Cycles Number of wash cycles between samples Air bubble Volume of air bubble Dead Volume Remaining volume inside the stop solution bottles Dispensation Mode Dispensation mode for the stop solution 1 well at time Dispensation mode for the stop solution 2 well at time Dispensation mode for the stop solution 4 well at time Dispensation mode for the stop solution 8 well at time Execution Time Execution time to dispensing a complete strip of stop solution User Manual ELISYS 2 Rev 6 51 75 Read Read Reading delay time Waiting time of the read
35. ead Name r Syringe speeds Hz Execution time s i Volumes pl Dispensing Washing Cycles Single 23 3000 froo 2 E Aspiration Air bubble 500 pooo Duplicate 24 Dead Control Vol Duplicate sample disp mode 200 Dispensing mode A Dispense diluent in the Off 1 well attime Dead Standard Vol TATO On 2 wells attime 200 r Dispense sample together with the conjugate Sample Dispensing Syringe speed for serum dispensation Aspirating Syringe speed for serum aspiration Washing Volume of liquid for the cycle washing Cycles Number of wash cycles between samples Air bubble Volume of air bubble Duplicate Sample Dispensation mode for the sample 1 well at time disp made Dispensation mode for the sample 2 well at time Single Execution time for a single dispensation of sample Duplicate Execution time for a double dispensation of sample Dispensing The diluent will dispense in the blank well 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 a Standard Remaining volume inside the calibrator vials ol 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
36. electing the Code field in the window and clicking on the Patient card button In the window which appears information regarding the patient and the sample can be inserted To accept the information given the following boxes must at least be filled in Patient ID Group Name Birth day Sample date e Time Patient s information already stored in the 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 information registered in the data base This allows to memorise the information of patients which have to be checked often In this case the program asks which operation to carry out More information about the patient chosen can be inserted by using the button More Notes There can be inserted up to 5 additional comments In this case the DataBase button can also be used proceeding equally as explained previously Ss Human Code Patient ID fl Group DataBase Name PC Oee i l 0 O0 d b M d d O O More data o Birth day i Sex CM CF More notes Sample dael Time Il 62 Cancel Help Group Name Patient cards database x x What do you want to do What do you want to do f Save the current patient s data in the archive Delete the current patient s data and pick one from the archive Oth
37. ensation 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 Conjuga5 ap2 e The file is empty dispensation already carried out immediately after the controls Chromoge5 ap2 dispensation volume 100pl e The syringe suck up speed is SV1000 The Chromogen suck up is carried out with just one move The dispensation speed is SV3000 Stop5 ap2 dispensation volume 100 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 25pl to 5011 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 2001 e The Conjugate dispensation on the blank wells is not carried out e The suck up syringe speed is SV1000 the Conjugate dis
38. er notes x if DataBase note note note note OoOO User Manual ELISYS 2 Rev 6 31 75 5 3 Run Analysis START RUN 1 Microplate composition to locate microplates into their own locations 2 2 2 Common reagents to locate reagents on the reagents trays 32135 lt 2 Vv 3 a Specific reagents for assay A to locate controls and calibrators assay A T WORK AREA DORE AREA 3 b Specific reagents for assay B to locate controls and calibrators assay B next PREPARATION 4 Sample sera to locate the samples into the tray Par 5 3 2 5 Dilution cups Prime to locate the predilution plates Don t forget to Start analysis locate the washing solution bottle 2 N locate the wash buffer1 buffer2 bottles locate the waste tank make sure they have been filled make sure it is empty YES Tank level controls ANALYSIS Prime execution EXECUTION y Par 5 3 3 Time flow for every operation ANALYSIS EXECUTION Session end remaining time Errors in process liquid not found D D B A B A couple of windows A A A A B B C C etc BLANK STANDARD VALUES CONTROLS for each assay DISPLAY EVALUATE next gt previous is presented RESULTS Par 5
39. er to perform the absorbance s reader 52 75 User Manual ELISYS 2 Rev 6 Ss Human 5 6 Rack Arrangements ELISYS 2 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 soa ring 18 x Universal Reagen Fig 2 Universal Common rack 5 6 1 Disposition on the Working Area Standard Racks 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 00009 HP oO lOIOI OL OO OO O a O OO OO0 D0 OO OO OO O00 OO HKS OoloorroolooloolooroolooO a Oloo oo loo ool oo100 lool loo ze 1 2 3 4 5 6 7 8 Sample rack Common Rack Reagents rack Standard Standard Fig 3 User Manual ELISYS 2 Rev 6 53 75 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
40. erating 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 warnings 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 disinfect the instrument following the applicable instructions See APPENDIX A 6 1 Checks andPreventive Maintenance See the below table for the recommended preventive maintenance operations Operation Cleaning the needle outside Alcohol soaked cloth Begin and at the end of each work session Washer prime with distilled water Tubing diluter and manifold decontamination see If necessary page 47 Replace syringe tip see page 47 Monthly General inspection and checks At interval of 6 months Using cleaning solution Recommendation Alcohol 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 60 75 User Manual ELISYS 2 Rev 6 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
41. erations of the instrument are prohibited The user is liable for any instrument improper modification 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 8 75 User Manual ELISYS 2 Rev 6 N Human SECTION 2 GENERAL INFORMATION 2 1 Instrument Description Purpose and Features ELISYS 2 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 Co 1 Cat No SERIAL N FABRICATED User Manual ELISYS 2 Rev 6 9 75 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 Arm Dtometer and e washer Needle Work area fig 2 2
42. ers 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 Sch lke amp Mayr Ges m b H WG 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 4 Remove all the accessories and disinfect the ones which have to be sent with the instrument 5 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 7 Leave the solution on the instrument for 5 hours clean the instrument surface by a light detergent or water to 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 Rev 6 65 75 Decontamination Declaration The Decontamination declaration as shown below has to be f
43. ght 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 54 75 User Manual ELISYS 2 Rev 6 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 portions I E 50 ul A 50 uL B F Plate pre washing Name IE Block number 3 Racktype 5 x Standing time 60 for solution Stop sol 2385 Hl St area A 3 Seconds Substrate 1 2770 pL Incubation times min r Reagent names Semple 50 x Substrate 2 2770 pL Sample Dilution incubation p Z na I Conjugate 100 hd Css mug r Stopping M naban 60 topping HCL Substrate 1 100 z Substrate ore 15 M Wash solution Homones Wash Substrate 2 100 5 Stop sol Go Wash cycles Filters nm ee D x Filter 450 r Dilution volumes washing Serum fo G ones El Filter 2 630 7 washing 7 1350 Diluent 0 Ontly Volume E I Empty wells atthe end Working parameters T Thermostat 37 0 Quantitative parameters Qualitative parameters Group par 131 INSEE Cancel WASHING SOLUTION S Homones Wash Wash buffer 1
44. he session is indicated o subsequently 1 1 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 a priming is performed by default if selected 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 34 75 User Manual ELISYS 2 Rev 6 Ss Human 5 3 4 Displaying the Results and their Acceptance Evaluation The results are shown at the end of the analysis process For each method Show the controls and cuves J Assay T3 there appear two windows On the first page the values of the blank are reproduced They can be Standard values ODI excluded from the evaluation removing Po 008 0 078 the selection in the corresponding 0240 er n 4 0 430 j raw the curve control box aie raw ove Also the standard values can be excluded from the calculation by marking the corresponding checkbox ee eee On duplicate determination it is eee possible to exclude only one value by marking the corresponding value directly
45. ify 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 Rev 6 23 75 5 2 Work Session Setup From the Session menu click on New to access the Profiles Selection window which shows the blank fields Remark 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 START SESSION New Modify SELECT PROFILE SELECT PROFILE Par 5 2 1 Es SET y CALIBRATION CURVE PARAMETERS SET PARAMETER
46. illed 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 substances the instrument and its accessories have been decontaminated to eliminate every biological substance which could be dangerous for personnel User Client name Address Country Responsible name Date Signature and Stamp 66 75 User Manual ELISYS 2 Rev 6 Ss Human APPENDIX B Spare Parts Consumables Accessory Parts A separate Spare Parts List is available in the Service Manual HUMAN Cat NO Description Reagent rack for HBV Reagent rack Infectious Diseases 17300722 Service Manual 1 1 1 1 1 1 1 1 1 User Manual ELISYS 2 Rev 6 67 75 APPENDIX C ELISYS 2 Rack Description RACK 1 RACK 2 RACK 3 EGA Hc Dengue IgG IgM x Fe Heli pylori leG leA 17301 58 17301 54 17301 55 RACK 4 RACK 5 RACK 6 Co 17301556 17301557 17301 93 17301589 free format UNIVERSAL COMMON RACK HORMONES HIV COMMON RACK INFECTIOUS DESEASES HCY AND HBY UNIVERSAL 1730159 1730 1 60 17301 90 used with RACK 1 used with RACK2 used with RACK 6 RACK 3 RACKT RACK 4 free format RACKS The Racks are optimized for Human Tests Rack 6 is a free format Rack and has removable rings
47. ing LAB file 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_lgG 2 Rubella_IgM 3 CMV_IgM lt Patients gt 1 PATIENT01 1 2 3 2 PATIENTO2 1 3 PATIENTO3 1 2 4 PATIENT04 1 2 3 5 PATIENTO5 1 6 PATIENT06 1 2 T PATIENTO7 1 2 3 8 PATIENT08 1 9 PATIENT09 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 74 75 User Manual ELISYS 2 Rev 6 N Human APPENDIX G Operating Flow Diagramm START at SELECT PROFILE Paga SELECTPROFILE cs SET y CALIBRATION forthianialive assays
48. initialised Follow the instructions shown on the screen The program is now installed and the ELISYS 2 icon is available on the desktop Double click on it to run the program W Remark For Microsoft Windows 98 Il Edition you need the BDE Installer version 1 0 start BDE Installer also with Setup exe 20 75 User Manual ELISYS 2 Rev 6 Ss Human SECTION 5 OPERATING INSTRUCTIONS 5 1 Introduction The instrument requires the use of chemical reagents and other dangerous corrosive irritant and harmful N 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 EN INFECTIONS or CONTAMINATION 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 pr
49. ion c 0 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 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 K constant a 0 b 0 c K Example 5 The cut off is available Having 3 controls NC CO PC supposing to put the Cut off in C2 position choose the following values for the coefficients NC negative control CO Cut off PC positive control a 0 b 1 c 0 46 75 User Manual ELISYS 2 Rev 6 5 5 1 Working Parameters Predilution YN Human Predilution Dispensing Syringe speed for dispensation of the diluent sample Aspirating Syringe speed for diluent aspiration Sample Aspiration Syringe speed for sample aspiration Washing Volume of liquid for the cycle washing Cycles Number of wash cycles between samples Air bubble Volume of air bubble Single Execution time for a single dispensation of sample Dead Vol Remaining volume inside the dilution bottles User Manual ELISYS 2 Rev 6 47175 Sample Prediluition Sample Conjugate Substrate A B Stop R
50. itions w P d Enable the predilution of controls Controls Prediuition E 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 absorbance to be determined 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 interpreting 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 sampile gt OD cut off t
51. le external washing B Peristaltic Pump for Microplate washer T1 Wash buffer 1 bottle for the microplates washing solution see note 1 T2 Wash buffer 2 bottle for the microplates washing solution T3 Wash bottle for the needle external washing solution see note 1 T4 Waste tank to collect the waste R Level control connector fig 4 2 User Manual ELISYS 2 Rev 6 17 75 Before switching on the instrument fill up 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 Note 1 At the end of a work session or for scheduled maintenance the instrument requires a washing cycle In this case 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 4 5 Work Area Figure 4 3 a and fig 4 3 b show a typical work area layout Needle Reader Washer Washing Group basin Microplates I U
52. lso 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 100pl 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 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 70 75 User Manual ELISYS 2 Rev 6 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 25pl to 5011 e If 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 100pl 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 just one move the dispensation speed is SV3000 Chromoge3 ap2 dispensation volume 100 1 e The syringe suck up speed is SV1000 the Chromogen dispensation is carried out with just one move the dispensation speed is SV3000 Stop2
53. lumn 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 Note 1 User Manual ELISYS 2 Rev 6 27 75 5 2 4 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 Ap2 Ap2 The number of requested strips is too large Error amp 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 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 increase A gt i gt ei en Patient card B A C Code
54. mbol is to advise that the instrument or part of the manual which is particularly important has to be consulted q 1 2 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 UN The instrument has to be used as described in this manual Any other use has to be regarded as improper User Manual ELISYS 2 Rev 6 7 75 1 3 W Use of the Instrument The instrument has to be used for the expected purposes and in perfect technical conditions by qualified personnel 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 described 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 received and using the original spare parts Alt
55. munity EN 50082 1 1992 CEI 110 8 The General Manager 6 75 User Manual ELISYS 2 Rev 6 N Human SECTION 1 GENERAL SAFETY WARNINGS 1 1 Danger Warning Symbols In this manual the following symbols are to remind the user of the safety rules This is a symbol of generic DANGER It means that serious dangers might occur to the operator 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 dangerous corrosive irritant and harmful CHEMICAL SUBSTANCES which can cause damages to people and material When this label is found pay attention to the producer s recommendations This symbol indicates that the instrument involves the handling of samples which can be infected 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 substances Use protective clothes gloves and glasses gt gt gt amp gt is symbol indicates that damages to the instrument and or its incorrect results could occur if the Thi bol indicates that d to the inst t and or its i t It ld if th e given warnings are not respected This sy
56. n and wash buffer names 5 8 Commands SECTION 6 MAINTENANCE 6 1 Checks and Preventive Maintenance 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 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 Rack Description APPENDIX D Group Rack Block Division APPENDIX E Definitions for Groups Group No 1 Group No 2 Group No 3 Group No 5 Group No 20 Group No 131 APPENDIX F On Line Module APPENDIX G Operating Flow Diagramm 4 75 User Manual ELISYS 2 Rev 6 Ss Human INTRODUCTION 0 1 0 2 Description The purpose of the automated microplates analyzer ELISYS 2 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
57. n 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 accordance 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 registration form is received by HUMAN within 15 days of installation of this product This warranty does not apply to damages incurred in shipment of goods Any damage so incurred shall be reported to the freight carrier for settlement or claim User Manual ELISYS 2 Rev 6 5 75 0 3 CE CONFORMITY CE DECLARATION OF CONFORMITY The producer declares that the instrument AUTOMATED MICROPLATE ANALYZER model ELISYS 2 Manufactured for HUMAN GmbH Germany Cat No 17300 conforms to the following EEC Directives included the last modifications 73 23 EEC regarding low voltage 89 336 EEC regarding Electromagnetic Compatibility 93 68 EEC regarding the CE marking and that the below harmonized standard specifications have been applied Safety CEI EN 61010 1 1994 CEI 66 5 Safety requirement regarding electrical equipment for measurement control and laboratory use Electromagnetic Compatibility Emission EN 55011 1989 CEI 110 6 Im
58. ns for each strip are occupied O cea strips 3 5 runt 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 pf ara The next window shows the display of the SESE Substrate 600 1 common tray where the necessary dilutors wash solutions stop solution and substrate ea must be arranged for all the methods to be oo processed in the session SI Note Different trays can be used for method sets SEE woes l wanna which require a different configuration Previous peN Run analysis x 5 3 2 3 Sp ecifi er eag ents fi or assay A B Put the following reagents on rack in position 1 The following windows show the sa arrangement of the reagents wash solution assai dilutors controls calibrators for each method eases abt foreseen in the session Negative Positive Assay A Previous User Manual ELISYS 2 Rev 6 33 75 5 3 2 4 Sample sera To ple sera The window below shows the disposition Put the samples sera as shown below PATIENTON of the samples on the sample rack G gt Ei PATIENTOZ PATIENTOS O PATIENTO4 Previous Run analysis r Predilution cups 5 3 2 5 Dilution cups BLOCK 1 The number of pre dilution cups ALL necessary for t
59. ogram start WORK SESSION OTHER FUNCTIONS Start work session or other functions Work session Par 5 2 na setup Par 5 4 Databases amp e I u een nee is Par 5 5 Settings lt See eee Run Analysis Par 5 3 oo Par 5 6 Commands te ter de tao ea FS Par 5 7 Help oi fn e er Table 5 1 General operating flow diagram User Manual ELISYS 2 Rev 6 21 75 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 ERROR red lamp indicating that the instrument is in running phase indicating that no liquid is inside some container of the work panel Note 1 The machine won t stop but the display shows the void positions 5 1 3 PC program starting The ELISYS 2 icon is available on the desktop Double click on it to run the program The main menu will appear Bk n 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 BZ css astio comes e New Medical Need e prime About Reports Lab name pri Modify Software Washer prime Show lab results paaris cards Docter mania A Moroplate Lab prirting T Se
60. ontinues 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 ELISYS2 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 x Error control n 1 of AFP not found Ignore 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 can be used to perform other tests i e washing 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 continue with the assay processing This function gives the ELISYS 2 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 In the settings menu the ext incubation option has to be marked 2 In the assay parameter settings of the concerned test the thermostat checkbox has to be marked 56 75 User Manual ELISYS 2 Rev 6 YN Human When these condition are fulfilled the software comes u
61. p with this message Answering yes gives the user the possibility to insert another test Human Elisys 2 After choosing an assay the software requests to remove the plate from the system and put the new one to the work position Human Elisys 2 During processing the new assay the remaining time from the external located test is displayed Remaining time 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 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 instrument 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 F COMI COM2 Demo Mode User Manual ELISYS 2 Rev 6 57 75 5 7 4 92 Positions for predilution A new segment for the predilution have been designed The new segment has enough space for 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 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
62. pensation is carried out with two moves the dispensation speed is SV3000 Chromoge3 ap2 dispensation volume 100pl e The syringe suck up speed is SV1000 the Chromogen dispensation is carried out with two moves the dispensation speed is SV3000 Stop2 ap2 dispensation volume 50ul 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 72 75 User Manual ELISYS 2 Rev 6 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 clients PC is established through the following files e INPUT Text file that includes the work list with WLT extension e OUTPUT Textfile 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 all information about the session results 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 firs
63. purpose requires a washing cycle for manifold cleaning bottle T1 has to be substituted with an equivalent bottle containing distilled water or decontaminating solution see Sect 4 4 for needle internal and external cleaning bottle T3 normally containing distilled water has to be substituted with an equivalent bottle containing decontaminating solution see Sect 4 4 6 4 General Inspections and Checks It is advisable to check periodically all the instrument parts User Manual ELISYS 2 Rev 6 61 75 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 replacing 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 glasbody free to move up and down Remove the guidance block see picture with a screwdriver Pull the plunger out of the glasbody Replace the tip Dissemble the hole unit Leave the sim program Prime the needle until the tubing system is free of air bubbles SO ONDOUPONZ 62 75 User Manual ELISYS 2 Rev 6 N Human SECTION 7 PUTTING THE INSTRUMENT OUT OF SERVICE 7 1 General Warnings Th
64. rial port vesting Prirter setup Assays Password Meroplate Pa Inge Steps Temperature Ext incubation Run Movements test Last resuts Exit Menu function explanation User Manual ELISYS 2 Rev 6 22 75 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 Ss Human To start a new 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 processed values for the samples controls and standards as well as any mistake 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 patient s name and or the execution session date To display modify and insert the patients in the database To display mod
65. sed 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 pl Between 100 ul and 400 pl 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 5 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 OD from 1 500 to 3 000 OD 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 OD Optical Density 1 or 0 010 OD whichever the bigger 2 0 001 OD in 1 minute N Human User Manual ELISYS 2 Rev 6 13 75 INSTRUMENT TECHNICAL SPECIFICATIONS Continued SERIAL INTERFACE RS232 ELECTRICA
66. 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 the 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 6 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 pl User Manual ELISYS 2 Rev 6 41 75 7 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 pl Empty wells at the end if the box is checked empty wells at the end of the washing cycles will result 8 Incubation time Incubation time in minutes for sample conjugate substrate The tree selected values
67. specific for each method In any case it is possible to change the axes scale decide to evaluate the samples based on memorised values keep them or proceed to a new curve calibration execute new 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 patient code Further clicks on that button will add a different progressive code for the following patient Session setup ENE ed a A aa 9 a ale IPATIENTO3 IPATIENTO4 PATIENTOS IPATIENTO6 Parent Taf Fe er aa a a a ale seek oe e a v M M i M lt I lt I m PATIENTOI Ll Le Le m qua q aS A m ku 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 Analogously 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 co
68. t 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 Select profie sr x Sample sack o ce fea z 60 sami sere oye pny od Host computer correction aus z Load wodiist S a Cancel dome 4 From Select Profile by pushing Load work list button the following window will be shown Select archive 2 gt Cerca in Ea AP22 e acea Nome file Apri Tipo file AP2 worklist archive wit v Annulla Select Archive allows the user to select the WLT file Click button Open to accept User Manual ELISYS 2 Rev 6 73 75 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 selected 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 result
69. the Tr IZ patient data and the results of the executed tests The average and CV are displayed if the test has been executed in double mode Qualitative tests show the cut off value and the test results positive negative or equivocal Show the results Quantitative concentration Next or Previous Laboratory Report All reports Patient data Delete analysis OK Code PATIENTO Pat D Code 1188s Laboratos SE Le a BirthDay Sex Report More data anni Assay 001 002 Mean CV CO Resut Al reports Pippo 1 024 0722 1418 i Patient data Delete analy tests show the pes BAR e by means of these two buttons can be displayed all the Work Session reports 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 session 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 displa
70. 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 Microplate 234567 8 9 101112 SOSSE SOODOELO IE SOSCOSCSSOOVES 00000000000 SECCECCOCO CE OOS OOO ee OS SPECS EIS FUOCO fig 4 3 b The microplate is a support for 96 reaction wells One or two microplates have to be located on their relevant places The washer and the photometer are able to run through the plate in order to read and wash the related wells Each microplate can host up to 12 strips each strip containing 8 wells The PC program advises to locate the microplates before the start of the running process see paragraph 5 3 zoaonmoou JOO OOOOU gt Warning to prevent instrument troubles during microplate washing sequence all the requested strips must be completed with the 8 wells 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 Reader Washer Group The reader washer group is located on the top of the microplates area It allows to run automatically
71. to fit different bottle sizes HUMAN Methods Methods can be executed together combined within one session 68 75 User Manual ELISYS 2 Rev 6 N Human APPENDIX D Group Rack Block Division TEST GROUP PAR RACK TYPE BLOCKN CMV IgG IgM EBV IgG IgM HSV1 IgG HSV2 IgG HSV IgM Measles Virus IgG IgM Mumps Virus IgG IgM Rubella IgG IgM Toxoplasma IgG IgM Varicella IgG IgM A OO Om Om Om A oO n dA s re Se i re ren A Caren Aa dA AA A A Om Om A Oo Aa LH FSH Prolactin WBWWWWWWW WW Testosteron Cortisol Progesteron E2 ESTRIOL DHEAS FT3 FT4 5 5 5 5 5 5 5 5 5 5 7 7 7 7 7 7 5 5 DOW 0 GI LI LI LI 0 LI LI GI LI GI LI WWW WI HbsAg anti HBs anti HbcAg anti HCV 4 3 3 HIV 1 2 2 4 5 Total IgE 131 7 3 _ Helicobacter IgG IgA Dengue IgG IgM 1 1 1 Note Bordered methods can be combined within on session User Manual ELISYS 2 Rev 6 69 75 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 Rubella IgG Rubella IgM Toxo IgG Toxo IgM Varicella IgG Varicalla IgM Helicobacter IgG IgA Dengue IgG IgM Predilu1 ap2 dilution ratio 1 100 e V1000 syringe suck up speed the sample dilution is carried out in two times the dispensation speed is SV3000 Sample1 ap2 dispensation volume 100pl e SV500 syringe su
72. ute the Oh 44 47 dispensation of the samples and controls in accordance to the selected assay settings 3 Conjugate s Selecting this item the machine will execute the Oh 12 37 dispensation of the conjugate in accordance to the selected assay settings 4 Substrate s Selecting this item the machine will execute the Oh 12 39 dispensation of the substrate in accordance to the selected assay settings 5 Stop solution s Selecting this item the machine will execute the Oh 12 32 dispensation 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 Rev 6 29 75 Session setup Self increase i Page 1 bi Bri Patient card AFP Code 4l Single steps A 1 gt Iv Dispense si use 2 gt Vv Activate microplate s Oh 1 18 3 a gt Vv Wash sample and control wells Oh 0 0 Wash conjugate wells Oh 1 21 4 5 Vv Run 6 7 7 gt gi E Run later 8 e Cancel gr un 10 gt Help Used wells az Full strips 3 24 CITITI 2 17 to dispense sera Wash Pressing this button the following menu appears
73. ution 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 M long as the operation hasn t been cancelled or until N Error the incompatibilities have not been removed The selected assays do not belong to the same block 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 I to the user confirming the change pieno 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 Rev 6 25 75 5 2 2 Set Parameters After clicking 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 quantitative analysis the execution modality qualitative or quantitative note 2 the reagents lot and its expiry the Cut off factor note 3 when to use th
74. wing window which displays the contained data User Manual ELISYS 2 Rev 6 37 75 5 4 2 The medical report of the patient for the selected session is displayed The report can be printed out by pressing the Print button By pressing OK the previous window is displayed CANCEL goes back to the main menu 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 session settings paragraph 5 2 3 1 Show reports Patient cards database Et Inf JAMES SMITH Patient card E sele 11 11 1937 38 75 User Manual ELISYS 2 Rev 6 5 4 3 5 4 4 N Human Notes This database contains a number of useful phrases used to comment the medical reports 01 This is a sentence 02 This other too Modify Delete It uses the same commands and mechanisms outlined previously Assays This dat
75. wood 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 When shipped or transported the instrument has to be provided with DECONTAMINATION DECLARATION see Appendix A of this manual 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 When stored the instrument has to be provided with DECONTAMINATION DECLARATION see Appendix A of this manual 64 75 User Manual ELISYS 2 Rev 6 Ss 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 potentially infected Prior to any repair or maintenance intervention and before transporting the instrument a decontamination is necessary by using wide band disinfectant solutions Warning USE LABORATORY PROTECTIVE CLOTHES DISPOSABLE GLOVES AND GLASSES WHILE DISINFECTING THE INSTRUMENT Fill in a decontamination declaration and enclose it with the instrument If the declaration is missing the customs offic
76. yed again by selecting the option View test results from the Session Menu 36 75 User Manual ELISYS 2 Rev 6 5 4 5 4 1 N Human Databases Session Databases Settings Commands Help Medical Reports Ctri R Patients cards Ctrl P Notes Ctrl T Assays 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 Report database Medical report database i Number of matched reports Medical reports The window lists the filed patients with at 2151212521 least 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 OK Cancel The displayed reports appear with their Mus 2 date and hour of the executed sessions Pat ID Code C1 Pim This helps to select the report to ae potas ans examine Sr 11 11 1937 Sex M Select a report and press PRINT to print out the report pera Report of 22 04 1999 12 50 Report of 22 04 1999 12 52 Select a report and press OK to enter the follo

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