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ECLP4050018V520-Eclectica User Manual V5.2.0

1. C c g U S R M A N U A L Release OpenLAB ADALTIS User manual ECLECTICA User Manual Software Release OpenLAB 5 2 0 ECLECTICA User Manual Revision A ECLP4050018V520 INDEX OF SECTIONS IN Oca dec ect E EEEE E INTRODUGCGHON aae EE EERE EE Preface Intended use Warning Illustrations Certificate of conformity List of Trademarks and Patents Information about the manual Manufacturer Document Purpose of the Document Symbolism How to use the Manual STE E E o A E E E A E E E E A E ren oe ner Secho 2 Labeline csdnacsrrcscrsyeapiasbaeeeiannnetueubce seca weit E NN Section 3 stallati OT seieren aa a aia a a Section 4 Operating principles eeeeesssssssssseeeeteeeressssssssssssesterereeessssssssssssssssseereereesssssss Secon a PUNCH ONS useaa nan nE A NEEE EENE E NEE EENE E Section 6 Operating precautions sssssssssseeeeeeeeesssssssssssssssseertrerrresssssssssseseeterersessssssssseses NECHOM I OPTION ssania a N N A A NENO Secon Ge VIAIMECI AICS sesana saunas atesesieasinsedeuduseessadseaidun EEEN Section 9 Troubleshooting cessisse sen erneieren OSEE Ea ESTen Section 10 Technical specifications cccccccccccccceccccccceesssessseeeeeecceceeceeeseceeauaaaaassseeseeeeeees Section 11 Supplementary informatiOn cccccccccccccccesessseseeeeeeeececceeeeeeeeeeeaaaaaassssseeeeeeeeess SECGHON eaa EE SAFET INSTRUCTIONS ri Operational prec
2. Preparation before Installation Mechanical Constraints Environmental Constraints Transport Checking for Damage Due to Transport Storage Information Provided Materials Consumable Materials accsacanceenasaneasnnanasancen ooie pionin Oer consumable scuer Ea Disposable MaeridlS cscri E aioa EES OMA VA ANG tease scans aeeasananccasasnnacesyasersanereastaaminnsaenanttceaesnaavteanacasiaasnoenneaoacaainauacantennsneas Materials supplied with the instrument cc ccccsesssseeseeeeeceeceeeeeeeeaaeaaeesseeeeeeeeeeeeeeeenaaas Installation Unpacking Electrical Connections Hooking up the Waste Tank Bottles Procedure for Connecting the Waste Discharge Tank ccccccccccccssssssssseseeseeeeeeeeeeeeeeeaaaas Procedure for connecting the Common Reagent bottles cc cccccccsssssseeeeeeeeeeeeeeeeeeeeeaaas First Start Up SECHON aie css tees a dc eeceteeeewusenedeeeeeeecueaeeceneeeeeeenneus OPERATING PRINCIPLES ccccccssssccsssssecssnsseccsnssecnnesscnenesssnensssnens Principle of immunoenzymatic assays Direct Immunoenzymetric Assay IEMA Phases 1 and 2 Phase 1 Immunochemical reaction cccccececcececcececcececcececcececeececeececescecacsecescecescucesceceees ECLECTICA User Manual Revision A ECLP4050018V520 Index Phase 2 Magnetic Separation ccccccccccccccccccccceeeceesssssesseeeeeeeeeeeeeeeeeaaseessesseseeeeeeeeeeeeeeeeeaaaeeaess Competitive Immunoenzymatic Assa
3. The peristaltic pump is mounted in the pump compartment on the right side of the instrument It washes the sampling circuits The wash cycles are predefined in such a way as to reduce contamination The wash station Fig 5 7 consists of 2 wash traps one for each needle and a wash liquid waste collection duct It is located between the reagents dish and the samples carousel The sampling needles are washed inside and out in their wash traps after every dispensing cycle The wash solution is delivered to the needles by the peristaltic pump The used wash solution is sent to the Waste Discharge Tank by a second peristaltic pump Magnetic Separation System ECLECTICA User Manual ECLP4050018V520 The magnetic separation system is composed of a permanent magnet located underneath the wash station on the right side of the instrument The magnetic separation system separates the immunocomplex that has formed as a consequence of the reaction from any excess free reagent Revision A 5 9 14 Section 5 ECLECTICA User Manual ECLP4050018V520 Functions The separation is achieved by approaching the magnet to the reaction Cells thus attracting the separation agent s magnetic particles to the lower exterior Section of the reaction Cell itself The liquid freed of magnetic particles can then be drawn up during the wash and spectro photometric reading cycles Revision A 5 10 14 Section 5 Functions Reaction cuvettes wash
4. User Manual Revision A 5 7 14 ECLP4050018V520 Section 5 Sampling Needles Syringe ECLECTICA User Manual ECLP4050018V520 Functions The sampling needles SN1 and SN2 Fig 5 6 aspirate and dispense respectively e Samples Immunochemistry Controls and Calibrators Diluents and Separation solution Common Reagent outer needle SN1 e Specific Reagents diluents samples and Clinical Chemistry calibrators inner needle SN2 L E E rie Pas Fig 5 6 Each needle has an electronic level sensor so as to minimize the depth of penetration of the needle into the liquid and recognises the presence of adequate volume Each needle is washed inside and out in a specific wash trap with the specific wash solution for the purpose of reducing carry over phenomena The syringe is assembled in the pump compartment on the right side of the instrument behind the Waste Discharge Tank The syringe has a capacity of 1mL It handles all precision aspiration and dispensing functions for the sampling system It draws and dispenses samples Specific Reagents Controls Calibrators Diluents and Separation Solution Common Reagent When a given volume has been dispensed and before the next draw cycle the syringe s integral solenoid valve is switched to deliver wash solution to the sampling needles peristaltic pump delivery Revision A 5 8 14 Section 5 Peristaltic pump Needle wash station Functions
5. Section 7 Operation Loading vials The vials of Specific Reagents must be inserted in the internal ring of the Reagents Plate in positions 1 20 The Controls Control 1 and Control 2 must be inserted in the external ring of the Reagents Plate in positions 1 28 see Fig 7 30 Fig 7 30 NOTE Each Specific Reagent and Control vial has a label with a barcode that must be oriented so that the barcode reader can scan it The loading position is unimportant since the instrument will automatically identify the positions by way of the barcode reader WARNING Before using the analyzer make sure that all the caps on the vials installed on the instrument have been removed thereby preventing collision with the Sampling Needles ECLECTICA User Manual Revision A 7 30 97 ECLP4050018V520 Section 7 Operation Package 02 Loading Common Reagents Kit Substrate Stop Solution Separation Agent The methods used to upload data and install vials of Common Reagents are described below Data upload Open the package of Common Reagents and remove the Smart Card I ADALTIS Smart Card Press Eclectica Smart Card Load Material on the bar at the top right Fig 7 27 A window will appear displaying the message Insert Smart Card Insert the Smart Card in the reader Insert the Smart Card with the writing facing upwards and the chip facing the instrument Wait for the red light on the reader to go out When th
6. The concentration of immune complexes is directly proportional to the concentration of analyte present in the sample the higher the concentration of analyte the higher the quantity of Ab2 ALP bound in the immune complex FITC Ab1 Ag Ab2 ALP Enzyme FITC Labelled labelled Analyte Antibody Antibody C E gt E E Fig 4 1 Immunological reaction in the IEMA assay ECLECTICA User Manual Revision A 4 1 17 ECLP4050018V520 Section 4 Operating Principles Phase 2 Magnetic separation At the end of the primary immunological reaction an excess of an anti fluorescein antibody bound to a magnetic particle is added This binds rapidly and specifically to the immune complex Analyte Antibodies Ab1 FITC Ag Ab2 ALP and to the antibody labelled with excess and free FITC These are sedimented with a magnetic field see Fig 4 2 Separation in the IEMA assay The quantity of enzyme bound to the magnetic particles is directly proportional to the quantity of analyte originally present in the sample The excess antibody labelled with the enzyme remains in solution and is eliminated by aspiration and washing Reaction Anti FITC Bound Free Excess Mixture magnetic Enzyme Enzyme particles labelled Labelled Antibody a mm B Excess FITC A Bound labelled antibody enzyme labelled Fig 4 2 Separation in the IEMA assay Competitive Immunoenzymatic Assay EIA Phases 1 and 2 Phase 1 Immunological reaction
7. User Manual Revision A 7 90 97 ECLP4050018V520 Section 7 Operation QUALITY CONTROL General Description The ECLECTICA quality control program records the results of control serum assays in order to monitor the accuracy and precision of the ECLECTICA system The quality control procedure includes e definition of control serums to be used on the system e analysis of control serums together with patient samples e comparison of expected and actual results to evaluate the analytic performance of the system This enables validation of the analysis and release of the report e Retrospective evaluation of the quality control results via statistical analysis of the results over time using graphic output Terminology Quality control A set of procedures aimed at validating a series of analyses by monitoring the accuracy and precision of the analytical system Mediana The sum of all results divided by the number of results The mediana is calculated as follows n x x n i Standard Deviation Statistical parameter that describes the spread of a population of data around its mean value The standard deviation is calculated as follows where n number of results and x mean Coefficient of Variation CV Statistical parameter that measures the spread of a population of analytical values around its mean The percentile CV is calculated as follows ECLECTICA User Manual Revision A 7 91 97 ECLP405
8. Generic error malfunction messages 1 ele rA fails to switch on Eo e cause The display is blank Mains power loss Solution NS o E K o that the power cable is connected Check that both switches on the back of the instrument are ON 2 The PC does not turn on Error Probable cause Solution o Message displayed The HDD could be Inform the Adaltis Hotline Service None System Disk damaged or disk error White text on blue Problem with the Switch off the computer and switch it on background operating system or again after a few seconds hardware Eclectica The software fails to Inform the Adaltis Hotline Service aaa fails to connect to the instrument start Message displayed PV error or Access Violation 3 Generic runtime errors The software does The software has generated Press CTRL ALT DEL on the keyboard Now not respond to an unexpected error select Task Manager and then the Applications commands tab Select Eclectica and then End Task Close Task Manager with the X button at the top left of the window Restart Eclectica click on the Eclectica icon on the desktop and press Enter Message displayed An invalid action has been Restart Eclectica as per the above instructions Key Violation performed The following errors Software instrument Press OK if the software still does not work appear communications error properly restart it as per the above XV RY RY1 MY WQ instructions VT OT If
9. If the sample has not been diluted try diluting it 2 If the sample has already been diluted try diluting it with a higher dilution factor 3 If all the results of the samples are higher than the range there may be a problem on the analyzer Contact the Adaltis Hotline Service NOTE The analyzer will indicate the sensitivity and range of the method Repairs and replacements in case of failure or breakage of the system must be performed exclusively by technicians authorized by Adaltis Srl Revision A 9 9 9 Section 10 Technical Specifications SECTION 10 TECHNICAL SPECIFICATIONS The ECLECTICA technical specifications are listed hereunder Dimensions and Weight Depth 66 cm Height 54 cm Width 85 cm Weight 60 kg Electric Requirements Voltage from 115V to 230V Frequency 50 60 Hz Power Consumption 200 VA typical Max 300 VA Environmental Requirements for Operation Temperature 15 C to 35 C Humidity 20 to 80 RH non condensing Height from 0 to 2000 metres Environmental Requirements for Storage Temperature 5 C to 45 C Humidity 5 to 95 RH non condensing Height from 0 to 9000 metres Electromagnetic Compatibility Safety The instrument conforms to the requirements of CEI EN 61326 1 1998 Electrical measurement control and laboratory equipment electromagnetic compatibility requirements and CEI EN 61010 1 1994 Safety requirements for electrical measurement control and la
10. execution of the last worklist including the method in question TEST NOT CONFIRMED The user waited more 4 No action than 24 hours after getting Invalid test or Temporary result Run only the Controls again to obtain the results of the samples selecting the worklist containing the controls to be executed from among the pending lists Values outside precision limits 1 During execution of 5 Pre err a worklist with samples and Controls the values The message appears inthe of the Controls are Remark field of the Execution outside the accepted Report range Remark 2 During execution ofa 6 Re run the worklist worklist with samples and Controls the values of the Controls are out of range ECLECTICA User Manual Revision A 9 8 9 ECLP4050018V520 Section 9 Troubleshooting Invalid test results Competences ECLECTICA User Manual ECLP4050018V520 In case of invalid test results for report purposes sample lt Sens or gt analytical range Samples lt Sensitivity 1 If the sample has already been diluted try diluting with a lower dilution factor 2 If the sample has not been diluted check that the result is in line with the case history otherwise repeat the test 3 If all results of the samples are lower than the sensitivity this may indicate the presence of a problem on the analyzer Contact the Adaltis Hotline Service Samples gt analytical range 1
11. system Adaltis Srl has created the Manual as a support during training and an essential reference during everyday use of the ECLECTICA system A brief summary of the contents of the 11 Sections of which the Manual is composed is given below The user must read this Section which describes the general safety precautions to be observed when using the instrument and its consumable disposable materials This Section describes the safety symbols applied to the instrument itself The user must read this Section which describes the instrument s installation procedure Section 4 Operating principles Section 5 Functions Read this Section to gain a better understanding of the system what it measures how it makes the measurements and how they are transformed into useable data and reports This Section defines every component of the system and explains its purpose and operation Section 6 Operating precautions ECLECTICA User Manual ECLP4050018V520 The user must read this Section which describes the precautions to be observed when preparing running assays and the associated risks Revision A 0 3 4 SECTION 0 Introduction Section 7 Operation This Section should be referred to in order to learn the operation of the instrument and how to run assays It must be studied during training and referred to frequently thereafter Section 8 Maintenance This Section specifies all the maintenance operations required for correc
12. Barcode reader identification system ccccccccccccccessessseseeeeeeceeeeeeeeeeaaaaessesseeeeeceeeeeeeeeeaaaaaeeeseses AIMS GG essai E ae EEEN Sma NEEE ee E E E E TE E E E VIN e ETE E sha mein E I A E E E T A AA A A AAE E A E Pore D a E E T E E E E E E INC NS vacha Oi garrien ai E E E E E E E EAE Magnete Separation SV SUC vin 12 ccntanscwouawiuseantacecawassatconsunuteaenbsiGdandusedneinsintdandusteapatisentuceinemieeacunds Reaction cuvettes wash System cz ccnitnssiwowansescandaanevawassadaonGusutsaenvsaddentuseeneleabintdaudintiaananthevostanetsawennte Conimon Reacents Saini In SV Ste Mi sisari iene ie n E Ea EA EEEE E CMT a a soa E E E E E A E EE EE deeesiotonaee Management Software SEC HON Gir E E ECLECTICA User Manual Revision A ECLP4050018V520 4 9 RESTRICTIONS meer 1 Restrictions on immunoenzymatic assays 1 Interpreting the assay results 1 SECTION Fa etait nice weiner deus EAE 1 OPERATION aos eieeestne ween sees eee ee ure can revs ee vene es uewecuntedsacasigonegeustensdacsdessducodduoduntssucdsucedsccasiepuedse 1 Preparation for operation 1 BSA FY AE E ET A E PEE EATEN ANE A EANA E EEE ET 1 GE AND EATE E E E E T E A EE EA E T l Preparing he Samples cirenean On a e a N a EA l Sorna he sanp leS orna a a a ar aae a E E 2 icnn TG Sa ES iroa E E E senedanunpsennapcaatsedoaieasnueamers 2 Dame CSE WDC S ratasstincacesscaneteisnssasctecoaeonrnoaouaneesaquaacaanesenedsoeh cecusuaezedsadnanecongeaneto sacs todenpansatansesaeann
13. HCG_1 1 E By Fig 7 51 The red dot associated with the test can be displayed in two different ways b solid red disc indicates the selection of all available dilution ratios even if just one is available e g 1 1 c red circle oj indicates that only certain dilution ratios have been selected NOTE to associate the same method with the most repeated selected samples press one of the following buttons repeatedly or amp Selection of all samples e Click on SELECT ALL All the samples will be selected Fig 7 52 ECLECTICA User Manual Revision A 7 52 97 ECLP4050018V520 Section 7 Operation lo Information To F F New Worklist SMP2 2 3 SMP3 2 curves Eme E CONTROLS wi Fig 7 52 e Select any cell of the column with the name of the Test to be programmed the FT3 test in the example of Fig 7 54 A red disc is displayed in correspondence with ALL the samples S ertai Sei PE F EE o Information TE Programming F Report Ki Finish Code F To we qe X G Remove R Patient o e To cancel all samples programmed for the selected test uncheck the predilutions box 1 1 dilution ratio TSH Wi TSH ECLECTICA User Manual Revision A 7 53 97 ECLP4050018V520 Section 7 Operation Deletion of a programmed or entered sample e Select the row corresponding to th
14. Installation Hooking up the Waste Tank Bottles The instrument must be connected to the Waste Discharge Tank and the bottles containing the Immunochemistry and Clinical Chemistry Specific Protein Common Reagents before being used Procedure for Connecting the Waste Discharge Tank The Waste Discharge Tank is placed in its housing located on the right side of the instrument see Fig 3 2 It is connected by way of the discharge pipe and electrical level probe connector This probe is programmed to activate when a maximum volume of 1 7L is reached Free space of at least 50 cm on the right side of the instrument is required to access the waste tank L Fig 3 2 Procedure for connecting the Common Reagent bottles The ECLECTICA instrument has 4 connection systems for the following 4 bottles e bottle containing the systemic wash solution e brown bottle containing the substrate e white bottle containing the stop solution e bottle containing the IA wash solution Each connection system is composed of e A cap with a collar of the same colour as the bottle to which it is to be connected e Amount to which the Teflon silicon fluid hose connects e A level probe connected to the instrument with an electrical connector only for connection to the Immunochemistry and systemic wash solution bottles ECLECTICA User Manual Revision A 3 8 10 ECLP4050018V520 Section 3 Installation The bottles containing the Common R
15. SN1 and SN2 for samples and Specific Reagents two needles for Common Reagents 8 needles for wash cycles and two for readings The system has the following precisions Samples sampling precisions Dispensing accuracy for 10 ul of sample control lt 3 CV Dispensing accuracy for 25 ul of sample control lt 2 5 CV Dispensing accuracy for 50 ul of sample control lt 2 2 CV Dispensing accuracy for 100 ul of sample control lt 2 2 CV Dispensing precision for reagents lt 2 2 CV for gt 50 ul Dilutors 1 dilutor with 1 precision syringe 1 ml capacity and resolution 0 3 ul Carry Over lt 20 ppm Precision lt 6 Incubation Dish Kept at 38 C 5 for IA Kept at 40 C 5 for CC Stability 1 C Incubation time Programmable Initial heating 10 minutes ECLECTICA User Manual Revision A 10 3 5 ECLP4050018V520 Section 10 Technical Specifications Photometric Reading Reading interval 0 3 0 OD Reading channels 2 Reading method horizontal type in flow Cell Reading filters 9 interference filters The standard supply is 340x2 405x2 492x2 546 578 630 Accuracy 1 0 2 0 OD extended to 8 0 OD by means of over range filter Resolution 1 mOD Photometer bandwidth Bandwidth 10 nm max Photometer carry over Carry over lt 10 ppm Volume of liquid waste produced Capacity up to 1 7L Immunology wash Wash procedure Same procedure for all assays 2 cycles 3 separation
16. Storing the Consumable Materials Identification ECLECTICA User Manual ECLP4050018V520 In order to prevent alteration of the Consumables store them according to the specifications provided in the instructions contained in the ECLECTICA Kit Assay Manual code ECLP4050000018 The ECLECTICA instrument is equipped with a barcode reader that enables positive identification of Specific Reagents Controls Calibrators Diluents by way of the barcode printed on every bottle The barcode used for these Reagents is code 128 see Section 10 Technical Specifications Revision A 7 6 97 Section 7 Operation Primary functions of the OpenLAB ECLECTICA User Manual ECLP4050018V520 The following headings describe the primary functions of the OpenLAB software required to execute assays using the ECLECTICA analyzer e Turning the instrument on e OpenLAB Start Up e Description of the primary functions e Running the Start up procedure e Consumable Materials Loading e Programming a worklist e Executing a worklist e Viewing and printing the results of a worklist e Executing the Shut Down procedure NOTE when executing the operations described in the following headings the management software can dialogue with the User by means of messages designed to assist in performing the relative operations correctly The meanings of the messages and any consequential procedures are described in Management sof
17. Tools Reagent Inventory Management Reagent Inventory Management for OpenLAB Suite 4 T Eclectica Maintenance Maintenance operation for Eclectica instrument Fig 7 2 Easy User Interface ECLECTICA User Manual Revision A 7 9 97 ECLP4050018V520 Section 7 Operation The Easy User Interface Fig 7 2 Easy User Interface allows you to program a worklist execute a worklist record an executed worklist manage the warehouse perform daily weekly maintenance activities on the instrument besa besa b2sa This section provides details of each of the above functions WARNING The ECLECTICA management software is touch screen operated and features a step by step help function Consequently you can go from one operating function to the next by means of the Next and Back buttons in the various pages Next opens the next page Back opens the previous page Always use the stylus provided with the instrument to select the icons on the screen Alternatively the trackball on the top RH side of the keyboard can be used In this case use the two buttons on the top LH side of the keyboard as the standard mouse left and right buttons ECLECTICA User Manual Revision A 7 10 97 ECLP4050018V520 Section 7 Operation Main Menu of the OpenLAB The OpenLAB functions makes it possible to run Immunoassay Clinical Chemistry and Specific Protein analyte tests
18. e Resources k Finish Run g 7 7 Open Worklist Curves Documents 7 Programmed Work Lists Backup stspwith Ready to run not executed Work Li Name Created LastModified Remove Eclectica 00092 01 03 2011 15 58 01 03 2011 15 58 TSH_1 1 ACG 1 1 HOG_1 500 TSH_1 1 HCG_1 100 HC 01 03 2011 15 55 01 03 2011 15 55 Eclectica 00091 ss don t want to show this page next time T Menu Pages Fig 7 69 Start the module relative to worklists execution select the Pending WorkList option Fig 7 69 and select the pending worklist containing tests not yet executed When processing is terminated the only tests that will be executed are those that were previously not completed Revision A 1 64 97 Section 7 Operation NOTE the lot of specific reagents that will be utilised in execution of the pending list MUST ALWAYS be the same as that selected in the previous stage execution of source worklist Curves Calibration curves management ECLECTICA User Manual ECLP4050018V520 In the curves page Fig 7 71 the state of every single calibration curve used to determine the analytical results and generated by the mastercurve or by a standardization routine is displayed see Calibration method for Immunoassay in Section 4 Operating principles Easy User Interface 5 2 0 gt Eclectica Work List Execution Eclecti e Reso
19. for Immunoassay tests The Calibrator vials must be inserted in the external ring of the Reagents carousel in positions 1 28 see Fig 7 36 od Calibrator vials Fig 7 36 NOTE Each calibrator vial has a label with a barcode that must be oriented so the barcode reader can scan it The loading position is unimportant since the instrument will automatically identify the positions by way of the barcode reader WARNING Before using the analyzer make sure that all the caps on the vials installed on the instrument have been removed thereby preventing collision with the Sampling Needles ECLECTICA User Manual Revision A 7 38 97 ECLP4050018V520 Section 7 Operation Package 06 Specific Reagents for Clinical Chemistry tests ECLECTICA User Manual ECLP4050018V520 Data upload Open the package of Specific Reagents and remove the Smart Card Press Eclectica Smart Card Load Material on the bar at the top right Fig 7 27 A window will appear displaying the message Insert Smart Card Insert the Smart Card in the reader Insert the Smart Card with the writing facing upwards and the chip facing the instrument Wait for the red light on the reader to go out When the data have been loaded the message Remove Smart Card will be displayed After the data have been loaded using the Smart Card the following information will appear on the Smart Card Viewer page Fig 7 37 for each method Eclectica Sm
20. for damages consequent on improper use of the instrument and reserves the right to take legal action to protect its interests on WARNING The user must strictly observe all information contained in this manual Failure to observe the precautions and restrictions on use given_in_ Section 6 Restrictions may result in damage to the instrument and environment injury to the user and generate incorrect results Revision A 1 1 14 Section 1 Safety Instructions Operational precautions ECLECTICA User Manual ECLP4050018V520 The ECLETICA system instrument and consumables is intended exclusively for in vitro diagnostic use The ECLECTICA system instrument and consumable materials is designed for professional applications It must therefore be used only by expert laboratory personnel Carefully read the general warnings given below in order to ensure proper use of the system e Make sure that all installation operations are carried out by technical personnel authorised by the manufacturer Adaltis Srl e Perform the maintenance operations described in Section 8 Maintenance Maintenance and or repair procedures that are not specified in the documentation provided by the manufacturer Adaltis Srl must not be performed e Follow all of the precautions normally adopted in the laboratory Good Laboratory Practice e Use only the consumables recommended by the manufacturer e Take all appropriate care in preparing an
21. instrument Click on Stop and save the worklist with the tests message Motor encountered a executed up to the time of the error error OK hardware problem The list will be marked as not executed and while running the test displayed under pending lists ECLECTICA User Manual Revision A 9 5 9 ECLP4050018V520 Section 9 Troubleshootin The following errors may arise while running an assay due to lack of resources The message for each error is given both in the Run page alongside the test and in the printout generated by the internal printer Run Page Internal printout Possible Cause Error Message error message Sample Level Reagent Level Separation Level Wash Solution Level Dilution error ECLECTICA User Manual ECLP4050018V520 TLEV ERR tube level error REAG ERR reagent level error SLEV ERR separation ag level error WASH ERR wash sol error Test result 0 No liquid detected in the samples test tube or in the Control Calibrator vial No Specific Reagent detected in the respective vial All failed tests which require this reagent are marked with this error No Separation Agent detected in the respective container All failed tests will be marked with this error No wash solution detected in the respective bottle All failed tests will be marked with this error No liquid detected in the samples test tube during pre dilution of the sample Revision A On
22. is ready to operate but we recommend contacting the Adaltis Hot Line Service because the photometer lamp may be approaching the end of its service life values are lower than 7 500 a red tick symbol will be displayed BF iongo the reading values of the reference filters the filter is not operational and the ECLECTICA instrument cannot run the tests in question Contact the Adaltis Hotline Service Revision A 8 26 32 Section 8 Maintenance Cleaning External cleaning of the barcode reader Use a gauze or cotton cloth dampened with distilled water to clean the barcode reader s scan window Dry off making sure there are no deposits or blemishes on the window External cleaning of needles and work area Follow the procedure given in Disinfecting the Work Area and Disinfecting Metal Needles ECLECTICA User Manual Revision A 8 27 32 ECLP4050018V520 Section 8 Maintenance Storing consumables on board the instrument ECLECTICA User Manual ECLP4050018V520 Clinical Chemistry Reagents Controls Calibrators and Diluent The vials_may be left on the instrument in compliance with the user instructions for each analyte make sure the Refrigeration System is left in operation and that the vials are closed with their respective caps Otherwise at the end of the work session remove all vials close them with their caps and store them in a refrigerator at 2 8 C Common Reagents The vials can be left on board th
23. not executed Work Li Name Created LastModified Description Remove Eclectica 00092 01 03 2011 15 58 01 03 2011 15 58 TSH1 1 ACG 1 1 Eclectica 00091 01 03 2011 15 55 01 03 2011 15 55 HCG_1 500 TSH_1 1 HCG_1 100 HC don t want to show this page next time I Menu Pages lt Back Next gt Finish Close Fig 7 67 Selecting the following option Fig 7 68 don t want to show this page nest time w Fig 7 68 the current page Fig 7 67 is not displayed at the next start of the execution module Click Next to go to the next page ECLECTICA User Manual Revision A 7 63 97 ECLP4050018V520 Section 7 Operation Execute a programmed Worklist Managing pending lists ECLECTICA User Manual ECLP4050018V520 In the Open WorkList page Fig 7 67 select Programmed Work Lists NOTE the selected worklist may involve execution of samples only samples and C1 and C2 Controls samples C1 C2 and standardizations for one or more tests Click on Next to go to the Curve section If certain of the tests associated with the samples are not performed during execution of a worklist the software will notify the user that the job has not been completed and will set the list to pending status When a pending list is reopened subsequently the facility will be provided to conclude the previously uncompleted tests Easy User Interface 5 2 0 gt Eclectica Work List Execution
24. phases Residual volume Residual volume lt 10 ml homogeneity to within 5 ml Dispensed volume Dispensed volume from 0 35 to 0 5 ml Magnetic particle separation Separation guaranteed for at least 95 of magnetic particles LIS interface ASTM Communications Protocol ref ASTM E 1381 95 Data format ASTM ref ASTM1394 91 XML ASCII as given in Service Manual code ECLP40600017V30 Characteristics of the software Capacity to run CC and IC assays in a single session Quality control software implements Controls on three levels Levey Jennings and Westgaard Rules ECLECTICA User Manual Revision A 10 4 5 ECLP4050018V520 Section 10 Technical Specifications Hardware specifications 12 LCD monitor Network interface card 2 USB ports 1 RS232 serial port Supports standard inkjet or bubble jet printers Internal thermal printer 80 column Integrated Smart Card reader ECLECTICA User Manual Revision A 10 5 5 ECLP4050018V520 Section 11 supplementary Information SECTION 11 SUPPLEMENTARY INFORMATION The present Section contains information regarding e Warranty Limitations e Spare parts and purchase orders e Order information Warranty Limitations Adaltis Srl Adaltis guarantees all products manufactured by itself hereinafter Product or Products under normal conditions of use against materials and manufacturing defects for a period of ONE YEAR from the date of shipping from the Man
25. proceed with the PC shutdown sequence before turning off the instrument Click on OK in both cases Empty out the Waste Discharge Tank WARNING Quit the Windows operating system before switching the instrument off ECLECTICA User Manual Revision A 8 12 32 ECLP4050018V520 Section 8 Maintenance You can now set the power switch to OFF The refrigeration system switch can be left ON if required ECLECTICA User Manual Revision A 8 13 32 ECLP4050018V520 Section 8 Maintenance Special The Special page Fig 8 6 is used to perform the following maintenance procedures Cleaning the instrument Emptying the Waste Discharge Tank Loading Common Reagents Cleaning Kit Washing Needles Replacement of Sectors Blank Check IA Fig 8 6 ECLECTICA User Manual Revision A 8 14 32 ECLP4050018V520 Section 8 Maintenance Wash with distilled water From the Special page Fig 8 6 press Water Wash This opens a confirm dialogue box Fig 8 7 Eclectica Maintenance 1 Remove the Substrate and Stop Solution vials ph and replace with distilled water bottles P Replace the 14 and the systemic wash solution with distilled water Load two bottles of distilled Water in positions Diluent 1 and Diluent CL Fig 8 7 e Open the drawer on the right side of the instrument e Unscrew the caps of the connection systems of the vials of Substrate Stop Solution and Immunoassay Wash Solution an
26. see Section 5 Functions Revision A 1 10 14 Section 1 Safety Instructions Disposal ECLECTICA User Manual ECLP4050018V520 e Reaction Cell wash system e Sampling Needles e Waste Discharge Tank e Reaction Segments e Wash trap These parts may be contaminated because they come into contact with biological fluids and reagents Refer to Section 8 Maintenance for the correct disinfecting procedure Every tool fixture used during the technical operations must be disinfected with the correct disinfecting procedures before being put away and stored The instrument and its components must be disposed of in observance of national regulations referring to the local environmental authorities Before disposal the instrument and its components must be decontaminated as explained in Section 8 Maintenance All waste materials whether liquid or solid must be disposed of in compliance with local laws and regulations Revision A 1 11 14 Section 1 Safety Instructions Chemical risk Disposal Electrical risk ECLECTICA User Manual ECLP4050018V520 Some reagents are classified as dangerous preparations according to the established legislation Every user must follow the rules of protection from chemical risk in the following conditions e during handling of samples Reagents Calibrators Controls and Diluents e during maintenance and when handling and disposing of waste e incase of spills and
27. splashes prevention and cleaning e during disposal and disinfection Refer to the instructions given on the labels of the bottles in the specific User Instructions for every assay contained in the Application Protocols Manual p n ECLP4050000018 and on the Safety Data Sheets All waste materials whether liquid or solid must be disposed of in compliance with local laws and regulations The manufacturer Adaltis Srl declares that all internal parts of the instrument are designed and made so as to prevent all possible risks for the user in accordance with established legislation The instrument does not constitute an electrocution hazard if installed without modification and if connected to an electrical power supply having the specified characteristics The instrument must be grounded See Section 3 Installation and Section 10 Technical Specifications for details regarding the electrical power supply Component replacements or repairs must be carried out by technical staff authorized to do so by the manufacturer Adaltis Srl ns WARNING Do not remove the instrument s guards and enclosures Revision A 1 12 14 Section 1 Safety Instructions Mechanical risk Risk of lesion ECLECTICA User Manual ECLP4050018V520 The User must learn and remember the basic rules to follow when working with mechanical equipment e be thoroughly familiar with the system and scrupulously follow the user and mainten
28. supplied concerns e the number of tests available for each kit e the values of ODs and mastercurve concentrations for IA and C1 and C2 controls e the values of calibration kit concentrations e the concentration values of each analyte for multiparametric calibrators Easy User Interface 5 2 0 gt Reagent Inventory Management Q aS Print Preview aS Print a Kit Info yp Eclectica Smart Card Material Load Recurrent queries Specific Reagents Hj Calibrators gt Common Reagents 3 3 Diluents 4 Specific Reagents Kits Immunology HCG HCG 00038 341212014 100 immunology TSH TSH ooga 3womzon 100 Menu Close Fig 7 20 You can make various warehouse searches by selecting Fig 7 21 the query required in the Query drop down box or by clicking on the buttons relative to the most frequently used queries Easy User Interface 5 2 0 gt Reagent Inventory Management p z Report 4 Curves Items w aS Print Preview aS Print y Kit Info yp Eclectica Smart Card Material Load AllAvailableTestForPackage a aes ts id Calibrators 3 Common Reagents 3 Diluents 4 Fig 7 21 ECLECTICA User Manual Revision A 1 23 97 ECLP4050018V520 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 1 10 a MI Query parameters AllAvailableTestForPackage Performs a search for consumables per package type from among the available uploaded materials Select Calibration Ki
29. the Smart Card the following information relative to the Diluent Kit will appear on the Smart Card Viewer page Fig 7 33 ECLECTICA User Manual Revision A 1 34 97 ECLP4050018V520 Section 7 Operation Eclectica SmartCard iewer Package Package Code 03 Analyte Analyte Code Diluent 1 for Immun General a foonz0 Serial number T0001 Expiry date 31 05 2012 Barcode Key 748E Available Tests Ss s lt sz Diluent Type 2 OQ OA 09 Diluent 1 Diluent 2 Diluent 3 Diluent 4 Diluent 5 Fig 7 33 e Lot Code e Expiry date e Max Volume maximum volume contained in a pack 3 x 20 ml bottles 60 ml e Smart Card serial number and barcode e Type of Diluent Diluent 1 Diluent 2 Diluent 3 Diluent 4 Diluent 5 Press OK Fig 7 33 and remove the Smart Card Once the Smart Card has been used it cannot be used again Loading bottles The Diluent bottles must be inserted in the specific wells located at the centre of the Samples Carousel see Fig 7 34 ECLECTICA User Manual Revision A ECLP4050018V520 7 35 97 Section 7 Operation WARNING Before using the instrument make sure that all the caps on the vials and bottles installed on the analyzer have been removed thereby preventing collision with the Sampling Needles Package 04 Calibration Kit ECLECTICA User Manual ECLP4050018V520 The methods used to upload data and install Calibrator vials
30. the application does not respond and a current worklist cannot be completed proceed as indicated in the previous point Internal printer does No paper in the printer Load the paper and try again not print The paper is incorrectly The blue paper lock lever is not engaged loaded down External printer The printer is not switched Check that the printer is switched on and if the does not print on or not on line printer has the option select On Line operation ECLECTICA User Manual Revision A 9 2 9 ECLP4050018V520 Section 9 Troubleshooting Start Up error messages 1 Generic Start Up errors Probable cause IA or IA CC The segment has not Check that the Reaction Segment is in position daily weekly Startup been placed in position 1 1 and that the first 4 reaction Cells are clean If not valid all the Possible bubble in the OK repeat the Autozero procedure autozero values or reading Cell If the problem persists contact the Adaltis only IA or only CC The reading Cells may Hotline show a red dot with be broken white cross Empty hydraulic circuit Normal lamp deterioration IA Blank not valid An out of range Selecting Repeat Blank Section 8 Blanks absorbance has been measured The values of Blanks 1 performed and 2 are out of the Selecting Repeat Blank Section 8 Blanks range from 1 to 150 Check ECLECTICA will repeat the blanks mOD execution procedure If the error message reappears change th
31. 0 Select one of the methods listed Fig 7 90 to display the report of the worklist executed on the selected method and to print it on the external printer NOTE if the external printer is not on line or if the user so requires it is possible to obtain a simplified version of the report using the internal printer after configuring the software appropriately see Additional Functions in this Section Easy User Interface 5 2 0 gt Eclectica Data Reduction Eclectica au0g4 gt Ri z Select Session Oo Information i Unit Measure m Readings G Report iv Finish Back Next Re Home aS Print Preview eS Print A Results Report VALID TEST Instrument sn Eclectica Eclectica001 Method TSH Session Eclectica 00094 Run Date 01 March 2011 16 59 Print Date 02 March 2011 09 27 Reagent Lot 0037A Quality ae a eat Menu c Pages Back Next Finish Close Fig 7 91 Clicking on the Graphic Curve symbol reveals a graph of the Calibration Curve calculated with the 5 parameter interpolation method Fig 7 92 Revision A 7 87 97 Section 7 Operation Easy User Interface 5 2 0 gt Eclectica Data Reduction Eclectica 0n094 Report Oo Information ina Unit Measure m Readings Ir Report Back Next Pea Home eee Print Preview aS Print wa wee F iv Finish lv Select Session fa 4 D cri Oo ao a i fa ks n a
32. 0018V520 Section 7 Operation CV SD Mean x 100 Quality Control Directives Quality control monitors the analytical quality of the system is an integral part of Good Laboratory Practice We explain below e How to select a control serum e When to run quality control How to select a control serum Always use control serums which are commutable with the patient serums on the ECLECTICA system For this reason use human origin control serums Adaltis recommends using control serums from the Quality Street range supplied by Adaltis itself and designed specifically for use with the ECLECTICA system When to run quality control Use control serums on the ECLECTICA system every day for each level of each serum For further information on Quality Control Theory and operations please see the QCP NET 4 2 software manual supplied by Adaltis Srl on request ECLECTICA User Manual Revision A 7 92 97 ECLP4050018V520 Section 7 Operation Additional Functions OpenLAB Options ECLECTICA User Manual ECLP4050018V520 The OpenLAB options can be accessed by selecting Options on the Easy User Interface side bar Fig 7 96 or pressing Page gt Options and selecting the Options item from the menu Easy User Interface 5 2 0 gt Home Page Worklist Management 4 clectica Work List Management Ref Home Create or Modify Work Lists for Eclectica v Back lt Worklist Execution Nest S al
33. 018V520 Revision A 7 21 97 Section 7 Operation Loading Consumables Reagents Inventory Management RIM The ECLECTICA OpenLAB software provides the facility to manage reagents warehouses and their contents load and unload the necessary material for correct execution of each work session ECLECTICA User Manual ECLP4050018V520 e Automatic uploading of data regarding the consumables for running Immunoassay Clinical Chemistry tests e Consulting the status of the consumables present in the warehouse From the Main Menu page select the Reagent Inventory Management icon Fig 7 19 Easy User Interface 5 2 0 gt Home Page Worklist Management Eclectica Work List Management Create or Modify Work Lists for Eclectica Worklist Execution Eclectica Work List Execution el Data Reduction amp Reporting instrument Maintenance Execute Work Lists on Eclectica Eclectica Data Reduction Perform data reduction for Eclectica sessions Eclectica Maintenance Maintenance operation for Eclectica instrument Management amp Tools Reagent Inventory Management Reagent Inventory Management for OpenLAB suite Revision A Fig 7 19 7 22 97 Section 7 Operation Reports The report page Fig 7 20 shows all the consumables present in the warehouse expressed in terms of kits with an indication of the relative lot and expiry date Additional information
34. 5 o OO o j o j o ulU ml Menu Pages Back Next f Finish Clase Fig 7 94 iv Finish Press Print Fig 7 94 to print the report Status of the test The test status may be different according to the status of the calibration The different conditions are listed below 1 Valid test it means either that the curve for that specific test is still valid or that the controls or the curve in case of 6 points calibration have been accepted during the current run 2 Temporary result The results are calculated using an expired calibration curve The corresponding printout on the internal printer during the run shows these results in parentheses The results can be confirmed within 24 hours 3 Test confirmed the calibration curve has been checked within 24 hours from the worklist execution and the controls were accepted The software recalculates automatically the results according to the new calibration curve 4 Test not confirmed the calibration curve has not been checked within 24 hours 5 Invalid test the controls of a new kit lot number were not accepted or the 6 points calibration curve has been rejected ECLECTICA User Manual Revision A 7 89 97 ECLP4050018V520 Section 7 Operation Report by Patient Selecting the Report by Sample link in the Session Report page Fig 7 91 the worklist report by patient is displayed The report gives the sample ID list of tests executed and
35. 83 97 ECLP4050018V520 Section 7 Operation wt na ra Finish j Report Default Unit Current Unit Protocol Normal values Measure Measure TSH ulum HCG miUinl Oo Information m Unit Measure m Readings z Select Session don t want to show this page next tine T Menu Pages Back Next Finish Close Fig 7 87 Editing the Normal value e select the method and press the corresponding button in the Normal values column e to add or remove afield click on Add or Remove button face 5 2 0 gt Eclectica Oo Information ml Unit Measure Default Unit Current Unit FormEditNormal alues Zi Finish ml Readings m Report lavmal ah ama Protocol Available normal value Healthy 0 6 4 8 ull ml Remove I don t want to show this page next time I Menu Pages Back Next Finish Close Fig 7 88 e Enter the Description and the corresponding Normal value and press OK to confirm Fig 7 89 ECLECTICA User Manual Revision A 1 84 97 ECLP4050018V520 Section 7 Operation Reading The Reading section Fig 7 89 displays the raw optical density values read by the photometer for each protocol The green flag to the left of the test names indicates that the raw test data are available for results calculation Sel
36. 8V520 Section 8 Weekly Maintenance Startup ECLECTICA User Manual ECLP4050018V520 Maintenance Eclectica Maintenance 1 sta sequence before tuming off the instrument aa A Please now proceed with the PC shutdown click on OK WARNING Quit the Windows operating system before switching the instrument off You can now set the power switch to OFF The refrigeration system switch can be left ON if required To ensure correct charging of the lines run a weekly Start Up in the following circumstances the analyzer has not been used for more than 48 hours the common reagents are replaced wash cycles are executed the analyzer has just been installed Run the following procedures with reference to the appropriate Sections of this manual External cleaning of sampling needles Cleaning the barcode reader Cleaning the work area Wash with Cleaning Kit Revision A 8 9 32 Section 8 Maintenance Fig 8 5 Select the Weekly tab and perform the operations as described in Daily maintenance ECLECTICA User Manual Revision A 8 10 32 ECLP4050018V520 Section 8 Shutdown ECLECTICA User Manual ECLP4050018V520 Maintenance The weekly shutdown includes a washing with the cleaning kit code 1700006 This kit is composed by 2 bottles of rinse solution they are used to clean substrate and stop solution tubings 10 bottles of cleaning solution they are used to clean the dis
37. 94 97 ECLP4050018V520 Section 7 Operation Clinical Chemistry Methods ANALYTE CLINICAL CHEMISTRY a COMMON REAGENTS for CLINICAL CHEMISTRY 100 TOTAL BILIRUBIN CHOLESTEROL HDL 109 CREATININE 110 ECLECTICA User Manual Revision A 7 95 97 ECLP4050018V520 Section 7 Operation 2 The 2 digits that identify the type of Reagent Control or Calibrator are shown in the following table Type of Reagent Control Calibrator REAGENT TYPE ECLECTICA pacent vee scuscea ao Code Calibrator A o A Calta a Calibrator C PAD Calibrator D Calibrator E O M Calibrator Fa CalibratorG S o 4 y A Reagent 1 for immunoassay 48 Control Serum 1 Substrate Ooo 52 2 bb oee a o Diluent 5 60 Multicalibrator for Clinical Chemistry 64 Reagent 1 for Clinical Chemistry o 6 O KFT Reagent 2 for Clinical Chemistry 6 Calibrator for Immunoassay Calibration Set 3 The 4 digits that identify the barcode key are given in the BarCode field in the Reagents Kit page for Specific Reagents and Controls and the Calibration Kit page for Calibrators in the Reagents Management module ECLECTICA User Manual Revision A 7 96 97 ECLP4050018V520 Section 7 Operation Clinical chemistry multicalibrators Barcode keys Analyte ae Multiparametric Calibrator for ACP ALP ALT GPT Clinical Chemistry AMYLASE AST GOT BIL DIR BIL TOT CA HDL CK NAK CREAT CHLORIDE GGT GLUCOSE IRON
38. At each change Distilled water Wash sampling of Common needles with cleaning solution Reagent bottles Wash with Wash Common Reagent v Distilled Water lines sampling needles with Distilled Water Empty the Waste Empty the fluids contained in vA Y Discharge Tank the Waste Discharge Tank Clean the exterior Clean with gauze or cotton v of the sampling cloth dampened with needles barcode hypochlorite solution reader work area Washing the Wash the sampling needles Sampling with cleaning solution v Needles ECLECTICA User Manual Revision A 8 32 32 ECLP4050018V520 Section 9 Troubleshooting SECTION 9 TROUBLESHOOTING ECLECTICA User Manual ECLP4050018V520 This Section describes the errors malfunctions which may arise during operation of ECLECTICA and the corrective actions required to remedy them It covers both problems that may foreseeably arise during operation of the analyzer and unexpected software error messages These error messages are normally in English since they are generated by the Operating System Windows XP or the application development environment The error messages malfunctions fall into the following categories e Generic error malfunction messages e Start Up error malfunction messages e Smart Card error malfunction messages e Barcode reader error malfunction messages e Execution and report error malfunction messages e Invalid test results Revision A 9 1 9 Section 9 Troubleshootin
39. ECLECTICA User Manual ECLP4050018V520 The immunological reaction of a competitive EIA assay uses a single antibody which labelled with the enzyme alkaline phosphatase binds the analyte to be assayed thus forming an immune complex At the same time an analogue of the analyte to be assayed is added which competes for the same sites of the antibody This called the labelled analyte is conjugated with FITC The labelled analyte competes with the analyte in the sample for a limited number of sites on the added antibody A displacing agent can be added to free the analyte from the transport protein so as to enable it to react with the antibody At equilibrium the quantity of analyte in the sample and the quantity of bound labelled analyte are inversely proportional to each other Revision A 4 2 17 Section 4 Operating Principles Low concentration samples the lower the concentration of analyte in the sample the greater the quantity of labelled analyte bound to the antibody marked with the enzyme Fig 4 3 Competitive EIA immunological reaction Low concentration sample Analyte Free analyte Analyte marked and free analyte in sample with FITC marked with FITC n gt gt E J m a ag RPE T Antibody marked with enzyme Phase 1 Competition low concentration sample Antibody bound to analyte Fig 4 3 Competitive EIA immunological reaction Low concentration sample High concentration samples The higher the
40. Ea M w oy Menu Pages Back Next Finish Close Fig 7 92 Click on the symbol alongside Control Result to display the values of controls and calibrators of the selected method Fig 7 94 Easy User Interface 5 2 0 gt Eclectica Data Reduction Ecdiechica 00091 gt Report E i Information i Unit Measure m Readings fm Report Fa Finish lv Select Session p Back ee Next we Home ee Print Preview eS Print ee Instrument sn Eclectica Eclectica001 Method TSH Session Eclectica 00091 Run Date 01 March 2011 16 35 Print Date 02 March 2011 09 30 Reagent Lot 0037A Reference Concentration Unit measure OD Concentration O a ae S E se a ee Ss ee a o j a a o TEEN de a el e o S ae s ea Sema Ce aras a SampteResut Calc Pass Menu Pages Back Next Finish Close Fig 7 93 The lower area of the Report shows the reported values on the samples for the selected test ECLECTICA User Manual Revision A 7 88 97 ECLP4050018V520 Section 7 Operation Easy User Interface 5 2 0 gt Eclectica Data Reduition Ee aaa Reps lv Select Session o Information Unit Measure ml Readings Oe _ Report Back Next TE Home eed Print Previe ee e e o o o oe o TORRE AR Tf m ft o 05 um et 0000 05 fr Co o OO f o O u C o ft 0000 5 Co 80000005 rt en ft 0000 fs Te ft sr ee e e o a o COo o ft 0000 05 fr ei 0000 05 u en ft 000 0
41. Eclectica Work List Execution Execute Work Lists on Eclectica Cc nE Data Reduction amp Reporting w Help v T Eclectica Data Reduction 7 Perform data reduction for Eclectica sessions Instrument Maintenance Eclectica Maintenance A Management amp Tools Maintenance operation for Eclectica instrument Reagent Inventory Management Reagent Inventory Management for OpenLAB suite xj r 0j Fig 7 96 NOTE It s strongly suggested to configure the options during the first installation of the instrument Some options cannot be configured by the user Any further modification should be carried out with the help of an authorized Application Specialist For more details about options configurations please refer to Technical Bulletin ECL 0065 EN Revision A 7 93 97 Section 7 Operation Reagent Controls Calibrator barcodes If it is impossible to read the barcodes of the Specific Reagents Controls and Calibrators from the labels you can calculate them by following these rules The barcode is composed of 9 digits e 3digits to identify the method e 2 digits to identify the type of reagent e 4 digits to identify the barcode key 1 The 3 digits which identify the method are given in the following table Immunology Methods ea B ing no IA 200 IA 200 COMMON REAGENTS __ REAGENTS PROLACTIN 006 TESTOSTERONE 09 C PEPTIDE 019 ECLECTICA User Manual Revision A 7
42. LDH P MAGN PHOS PROTEIN TRIGLYC UREA URIC ACID Calibrator for HDL Cholesterol HDL Cholesterol Calibrator for LDL Cholesterol LDL Cholesterol ECLECTICA User Manual Revision A 1 97 97 ECLP4050018V520 Section 8 SECTION 8 MAINTENANCE General Rules ECLECTICA User Manual ECLP4050018V520 Maintenance Proper maintenance of the ECLECTICA system is one of the activities of foremost importance in order to guarantee that e the system is kept in ideal operating conditions so that correct results are guaranteed e all checks adjustments and repairs are scheduled in advance before the analytical results are compromised e loss of time due to system Shut Down is minimized This Section provides the user with general recommendations for proper maintenance of the instrument Maintenance comprises operations that must be performed by the user daily weekly and whenever the need arises Also periodic maintenance activities are envisaged usually every six months to be carried out by qualified Adaltis Srl Technical Service personnel WARNING Improper maintenance could jeopardize good operation of the system The daily and weekly maintenance procedures described in this Section must be performed by the user who works with the analyzer Should the system s parts fail or break any repair or replacement must be carried out by technical personnel authorised by Adaltis Srl Revision A 8 1 32 Se
43. LP4050000018 e Observe the restrictions of use for the individual assays given in the user instructions provided in the ECLECTICA Assay Manual code ECLP4050000018 WARNING failure to observe the above instructions may generate incorrect results e Contact the Adaltis Hotline Service if you receive packages of consumable materials not shipped in compliance with the given specifications In addition to the above materials the following other consumables are required to use the instrument correctly Materials supplied by Adaltis Srl Cleaning Kit Solution for cleaning of hydraulic circuits and sampling needles to be used for the wash cycle specified in the maintenance procedure see Section 11 Supplementary Information Thermal paper for the internal printer Necessary materials supplied by Adaltis Srl upon request 12 x 75 mm test tubes used for samples and multicalibrators Necessary materials not supplied by Adaltis Srl 12 16 x 50 100mm test tubes for pre diluting the samples and multicalibrators Distilled water for the wash cycle specified in the maintenance procedure Sodium hypochlorite solution used for the disinfection cycle specified in the maintenance procedure Revision A 3 5 10 Section 3 Installation Disposable Materials The disposable materials are the Reaction Segments disposable plastic containers in which all assay phases except photometric reading are run Optional materia
44. ON cccsececeeteseeeeeeeseeseeeneeseneneeeees Warranty Limitations ECLECTICA User Manual Revision A ECLP4050018V520 Index Index List of spare parts Accessories Consumables Information for Orders Technical service Forms ECLECTICA User Manual Revision A 9 9 ECLP4050018V520 SECTION 0 SECTION 0 INTRODUCTION Preface Intended use Warning Illustrations Introduction The ECLECTICA system is the latest innovation in the field of laboratory instrumentation offered by Adaltis Srl In order to assure proper operation of the instrument the user must observe simple standards and procedures schedule maintenance and respect the basic principles of its intended use In order to guarantee these conditions Adaltis Srl provides the present Manual as the main reference for all functional and technical aspects Adaltis Srl s Client Service Department is at the user s disposal for any Support requirements The ECLECTICA system runs doses for determining Immunochemistry and Clinical Chemistry The ECLECTICA system is intended for use in in vitro diagnostics The ECLECTICA system software and documentation are copyright protected All rights reserved The software and documentation have been developed exclusively for use with Adaltis Srl instrumentation intended for in vitro diagnostics applications Any copying or reproduction in any form or all or part of these materials for any other u
45. Pages Fig 7 71 If the daily Start Up procedure has not been performed you will be prompted to open the Maintenance section to launch the Start Up If the resources on board are sufficient all the programmed tests will be executable If the resources on board are insufficient specific warning messages will be displayed prompting the user to e Load Specific Reagents e Load Controls for all the programmed tests requiring the execution of controls C1 C2 e Load Calibrators for all the programmed tests requiring standardization e Load samples e Load Common Reagents e Load Diluents ECLECTICA User Manual Revision A 7 67 97 ECLP4050018V520 Section 7 Operation The User can anyway execute only those tests in relation to which the resources loaded on board the system are sufficient non executable tests will result in a pending list see Section Management of pending lists Resource Manager is opened by clicking the Show Resources button and it shows the reagents plate Fig 7 73 and the sample carousel M Resources Management x e Scan Samples moving to 25 Left Right Reagents Calibrators and Controls Samples and Diluents Name Position Method Lot Available units Fig 7 72 To allocate a reagent proceed by using the bar codes or manually Barcode position the vials on the respective rings in the reagents carousel no specific order required ensuring the barcodes are facing the centre of the
46. There are two types of End Point reaction single reagent Fig 4 14 End Point reaction two reagents or two or three or more reagents 0 5 Fig 4 15 End Point reaction two reagents Revision A 4 14 17 Section 4 Operating Principles Kinetic reactions ECLECTICA User Manual ECLP4050018V520 This type of reaction is generally used to measure the catalytic activity of enzymes Reading in UV at fixed well defined intervals of time The resulting AE is multiplied by the specific factor for the analyte in question AA minx VT x 1000 A minx 2 200 x 1000 AA minx x 17680 exdxVc 6 22 x 1 x 0 200 Example U L AST activity in international units per litre AA min Diminution in absorbance per minute mean of three readings VT Total reaction volume 1000 Conversion into litres of volumes e Micromolar extinction coefficient of NADH H 6 22 cm ymole at 340 nm d optical range 1 cm Vc Volume of sample in final reaction mixture Revision A 4 15 17 Section 4 Operating Principles Kinetic reactions can also involve one or two reagents see Fig 4 16 Kinetic reaction Single Reagent andFig 4 17 Kinetic reaction Two Reagents aes egret TEL a T eee ee i l l l l Ee Pia lee S Pee Lol caknar ES Si Fig 4 16 Kinetic reaction Single Reagent 0 4 0 3 2 i q 92 ns 0 1 0 N co lt t w N co Da D N eo
47. W ork liS eere E a E E E E r E e 47 ENO ETAn Te O E AET EAE E E EA A S E E E S 48 Samples Prostrani E srecni n a E eee E T EEEa EE Eae EA e EERE 49 Report of the programmed worklist sos scsscssceceecoscdibeccanachucedanbetanaeceededdeadenens bcundbsiaaeatanad abated iaabudeanaderintsachesdactddacebcuadedenmncestanes 59 E a E E T E E A I E A AE A N A A A TA T A A A A E 6l ECLECTICA User Manual Revision A 5 9 ECLP4050018V520 Executing a Worklist Selection of the worklist to be executed cccccccccccccecceeeeassssseeseeseeeeeees Execute a programmed Worklist ccccccccccceecececeeeeeeeseesseeeeeeeeeeeeeeeeeaaas Managing pending lists cccccccsssssssssseseeecceceeeeeeeeeeaaaeesssseeeeeeeeeeeeeeeeaaas Curves Calibration curves management ccccccccssssseeeeeeeeeeeeeeeeeeeeeeaas BS 5 EOS A E E E A E A Automatic samples 1dentification ccccccccccccccceeeesesseeseeeeeeeeeeeeeeeeeeeeeeaaas Loading Common Reagentt cccsssssesssseeeececeeeeceeecaaeaeesseeeeeeeeeeeeeeeeeeeaaas VIEWING AND PRINTING THE RESULTS OF A WORKLIST Selecting a Worklist Uni CO Me aS ULSI Mi ceirnin Re e E PEDO e E E E Report by single method nennsesssssseeeoeeeeeessssssssssssssssseeeereresssssssssseseseereees Status of the BOSE oc cccswanseronslenssanawdevandeneetinwsauseiesdanmssonvanaeenatinae tons encttenpennntendetes Report DY Patient aienctosicesdeerecenannsavensnamedewsseswvey treener teotan isisis
48. X20mm NO So i Sostituire i fusibili soltanto con altri dello stesso tipo e portata Replace fuses only with same type and ratings ECLECTICA User Manual Revision A 2 1 9 ECLP4050018V520 Section 2 Labelling Disposal of Electrical and Electronic Waste Label The adhesive label bearing this symbol is located on the rear of the analyzer close to the instrument identification It informs the User regarding Directive 2002 96 CE and Decree Law 25 July 2005 No 151 regarding disposal of electrical and electronic waste This Directive requires that electrical and electronic products be disposed of in an adequate manner so as to avoid any negative impact on the environment This makes it compulsory to use a differential waste collection system as well as special electrical and electronic equipment waste EEEW treatment and disposal methods CE Mark Label This label indicates compliance of the instrument to the essential safety requirements envisaged by the applicable European Directives It is to be found on the rear of the instrument ECLECTICA User Manual Revision A 2 2 9 ECLP4050018V520 Section 2 Labelling Safety Warning Labels Label 1 Generic Hazard ECLECTICA User Manual ECLP4050018V520 The labels given below are placed on the instrument in order to ensure it is correctly and safely used It is important that the user knows their meanings and positions The labels also identify the po
49. above general information Adaltis Srl does not guarantee the commercial value of the product nor its suitability for any particular purpose No affirmations or interpretations not expressly contained in this document are binding on Adaltis Srl as regards the warranty Adaltis Srl is not liable for damages expenses or damage to the client or third parties due to accidental causes Adaltis Srl is bound to repair or replace the product under the circumstances specified in this document This Warranty does not affect any statutory rights ECLECTICA User Manual Revision A 11 1 3 ECLP4050018V520 Section 11 Supplementary Information List of spare parts Accessories Consumables ECL34341000000 Samples carrousel 60 positions ECLS4050000028 Adaptor for sample tubes 65 pieces 2MP000053 USB Desk Jet Printer Waste Discharge Tank ECLP2030000002 Pack of thermal paper 1 roll ECLP4050000007 Pack of Reaction Segments 100 units 1700006 Cleaning Kit ECLP40500017V31 ECLP4050000018 ECLECTICA Kit Assay Manual ECLP4050CDV31 CD containing the user manual in the available languages ECLECTICA User Manual Revision A 11 2 3 ECLP4050018V520 Section 11 supplementary Information Information for Orders Contact the Adaltis home office or your local dealer Technical service Technical service is provided by the Adaltis technical assistance service Forms The manufacturer Adaltis Srl surveys the level of satis
50. age Fig 7 77 displays the samples carousel The following information is given for each sample Contents e inthe Name field e in the Position field the position assigned in the Samples Carousel The following information is given for each protocol Protocols e Test name e Lot e Number of programmed tests e Executable Tests be Scan Samples moving to 1 7 ett Right w Q Reagents Calibrators and Controls Samples and Diluents Fig 7 77 Automatic loading If the Automatic Sample Allocation parameter in the options has been set to True Refer to the heading Additional Functions the samples will be loaded automatically on the carousel in a sequential position Manual loading To load all the samples in sequence on the samples carousel starting from the selected position of the plate click on Load gt All samples with the left mouse button Fig 7 78 ECLECTICA User Manual Revision A 7 72 97 ECLP4050018V520 Section 7 Operation Scan Samples moving to 1 P tet Right w G Reagents Calibrators and Controls Samples and Diluents ProgrammedTests ExecutableTests _ 99 4 5 So Name sd Position Dilution ra At the end of the procedure the screen will show the position of each sample and the programmed tests to be executed If samples with dilution are programmed the positions of the undiluted samples will be displayed and also the empty tubes to be inse
51. ages display tab page Fig 7 15 CLS Lavy VTI n Los Jad uy eres J F b New Worklist oO Information a Programming E Report Ki Finish Create New Work List Archived Work List Backup i List of available Panel Filters List of Archived Work List Name Created Last Modified ee eclectica 01 03 2011 11 17 01 03 2011 11 17 Details don t want to show this page next time I lt Back Next gt Finish Close Fig 7 15 WLM module Select the Pages Fig 7 15 button and uncheck the Show Tabs option Fig 7 16 Show Tabs New vyorklist Information Programming Report Finish Fig 7 16 The selected module is displayed without the tab page Fig 7 17 ECLECTICA User Manual Revision A 7 20 97 ECLP4050018V520 Section 7 Operation Easy User Interface l 5 2 0 gt Eclectica Work List Management Documents _ Create New Work List Archived Work List Backup List of available Panel Filters List of Archived Work List Name Created Last Modified Remove eclectica 01403 2011 11 17 01403 2011 11 17 Details don t want to show this page next time J Menu Poses lt Back Next gt Finish Close Fig 7 17 To select a page of the wizard select the Pages button and choose the required page Fig 7 18 New Worklist Information Programming Report Finish Fig 7 18 ECLECTICA User Manual ECLP4050
52. ance instructions e Make sure that all covers and guards are operational Component replacements or repairs must be carried out by technical staff authorized to do so by the manufacturer Adaltis Srl The laser light generated by the reagent sample barcode reader may damage the eyes Do not stare into the source of light An accidental glance into the beam of light is not harmful Revision A 1 13 14 Section 1 Safety Instructions Emergency stop procedure In case of emergency e Use the switches located on the back of the instrument e Set both switches to OFF indicated by the symbol O on the switch plate e Remove the power cord from the socket outlet NOTE when the instrument is next switched on all data regarding the current assays will be lost ECLECTICA User Manual Revision A 1 14 14 ECLP4050018V520 Section 2 Labelling SECTION2 LABELLING The ECLECTICA instrument bears a number of labels which e Identify the instrument e Bear its CE Mark e Bear safety warnings symbols and phrases to which the User must pay attention Instrument Identification Label This label identifies the manufacturer the instrument type the serial number power supply and the fuse specifications It is to be found on the rear of the instrument ADALTIS ADALTIS S r L Via Durini 27 20122 Milano Italy PIN ECLI4100109003 SIN XXXXXXXXXX 90 260V 50 60Hz FUSIBILI FUSE T2A 250V TIPO TYPE S
53. appearance of the main menu with the side navigation bar Easy User Interface 5 2 0 gt Home Page T ees m clectica Work List ent As Home Create or Modify Work Lists for Eclectica v Back Worklist Execution Next i Eclectica Work List Execution e Execute Work Lists on Eclectica Me Options lt f EE et Rei son amp Reporting w Help Eclectica Data Reduction Wie Perform data reduction for Eclectica sessions Instrument Maintenance Eclectica Maintenance Maintenance operation for Eclectica instrument Management amp Tools on R Inventory Management Reagent Inventory Management for OpenLAB suite Fig 7 6 Revision A 7 15 97 Section 7 Operation How to display the Title bar ECLECTICA User Manual ECLP4050018V520 Select the Menu gt Options button and check the Show Title Bar option Fig 7 7 to hide the upper title bar Show Navigation Bar Show Title Bar Show Status Bar Setting Options Aboue Fig 7 7 The following screenshot shows the main menu with the title bar Easy User Interface 5 2 0 Worklist Management Eclectica Work List Management Create or Modify Work Lists for Eclectica Worklist Execution ol Eclectica Work List Executi Execute Work Lists on Eclectica Data Reduction amp Reporting P Eclectica Data Reduction Perform data reduction for Eclectica sessions instrume
54. are described below Data upload Open the Calibration Kit package and remove the Smart Card ADALTIS Smart Card Press Eclectica Smart Card Load Material on the bar at the top right Fig 7 27 A window will appear displaying the message Insert Smart Card in reader Insert the Smart Card with the writing facing upwards and the chip facing the instrument Wait for the red light on the reader to go out When the data have been loaded the message Remove Smart Card will be displayed After the data have been loaded using the Smart Card the following information will appear on the Smart Card Viewer page Fig 7 35 relative to the Calibration Kit Revision A 7 36 97 Section 7 Operation ctica SmartLard Viewer Package Package Code 04 Analyte Analyte Code HCG m General 7 m Calibrators Lot _ o Concentration Serial number P 0003 Cal A fo Expiry date 297027201 2 Cal B 4 21 0 Barcode Key 543E Cal C 21 900 Available Tests fia Cal D 99 800 Cal E 243 100 Cal F 485 400 Cal G fo Fig 7 35 e Method Code e Lot Code e Expiry date e Tests Available e Smart Card serial number and barcode e Concentration values of the calibration curve Press OK Fig 7 35 and remove the Smart Card Once the Smart Card has been used it cannot be used again ECLECTICA User Manual Revision A 1 37 97 ECLP4050018V520 Section 7 Operation Loading Calibrator vials
55. arnings normally used in an analysis laboratory Good Laboratory Practice are followed In order to avoid risks every user must observe the biological safety rules in the following conditions e during handling of samples Reagents Calibrators Controls and Diluents e during maintenance and when handling and disposing of waste e incase of spills and splashes prevention and cleaning e during disposal and disinfection The user and other personnel working in the proximity of the instrument for any reason must remember that e the Specific Reagents Controls Calibrators and Diluents may contain substances of human origin e all substances of human origin are potentially infected none of the known analytical methods can absolutely guarantee that products of human origin do not transmit infections e some ECLECTICA system reagents contain materials of animal origin Although these are certified as coming from healthy animals handle them with the same precautions taken when handling potentially infected samples The user and other personnel working in the proximity of the instrument must e always wear laboratory clothing disposable gloves and protective goggles when handling the samples to be analysed e not eat drink or smoke in the laboratory Furthermore take specific care when using maintaining and disposing of the following components of the instrument for a detailed description of the instrument s components
56. artCard Viewer Package Package Code os Analyte Analyte Code JURICA General j Lot Serial number Po005 Expiry date 31 08 2011 Barcode Key 978C Available Tests f 20 Reagent Codes Rea 1 e5 Rea 2 66 Fig 7 37 e Method Code e Lot Code e Expiry date Revision A 1 39 97 Section 7 Operation e Tests Available e Smart Card serial number and barcode Press OK Fig 7 37 and remove the Smart Card Once the Smart Card has been used it cannot be used again Load then reagent vials as described in paragraph Package 01 Specific Reagents Kit upload NOTE no C1 C2 calibrators for CC tests Package 07 Parametric Multicalibrator ECLECTICA User Manual ECLP4050018V520 The following section describes the methods used to load data and vials of Parametric Multicalibrator Data upload Open the Parametric Multicalibrator package and remove the Smart Card fs Mf aoatris Smart Card Press Eclectica Smart Card Load Material on the bar at the top right Fig 7 27 A window will appear displaying the message Insert Smart Card Insert the Smart Card into the reader Insert the Smart Card with the writing facing upwards and the chip facing the instrument Wait for the red light on the reader to go out When the data have been loaded the message Remove Smart Card will be displayed After the data have been loaded using the Smart Card the following information relat
57. ast number in the to field press Add ECLECTICA User Manual Revision A 1 49 97 ECLP4050018V520 Section 7 Operation Fig 7 47 The columns contain respectively Immunoassay IA and Clinical Chemistry CC tests that can be executed on the analyzer Fig 7 48 To display the available tests click on the following symbol at the top of the page Fig 7 48 ECLECTICA User Manual Revision A 7 50 97 ECLP4050018V520 Section 7 Operation Fig 7 49 Immunoassay Tests Programming the Tests to be performed on samples e Select the row corresponding to the required sample e Select the cell corresponding to the column with the name of the Test to be programmed e A red dot is displayed in correspondence with the test programmed on the selected sample Fig 7 50 E New Worklist lO Information ais Programming T Report zi gt chy s i fe4 Ri S re Code From To wr ww Add Remove R Patient O LLS Barcode Menu Pages lt Back Next gt Finish Close Fig 7 50 For all selected methods for which the test can be run on a diluted sample the Dilution factors window opens to allow the required Dilution factors to be selected Fig 7 52 ECLECTICA User Manual Revision A 7 51 97 ECLP4050018V520 Section 7 Operation M HCG MV HCG_1 500 M HCG_1 250 MV HCG_1 100 M HCG_1 25 M HCG_1 10 WMI PREGOS 7M
58. ate 01 March 2011 Work List n Eclectica 00092 Author User Instrument sn Eclectica001 Signature Menu Pages lt Back Next gt Finish Close i Fig 7 64 Sort by Patient To arrange patients in alphabetical order click on the Patient label shown in the red box Fig 7 64 Easy User Interface 5 2 0 gt Eclectica Work List Management Ec E New Worklist Information Programming 7 Report b Back Next TS Home as Print Preview ag Print J2 gt Report i V Finish Work List Report Company ADALTIS S r l Date 01 March 2011 Work List n Eclectica 00092 Author User Instrument sn Eclectica001 ECLECTICA User Manual Revision A 7 59 97 ECLP4050018V520 Section 7 Operation Sort by Test To arrange the Tests in alphabetical order click on the Method label shown in the red box Fig 7 64 V Finish Easy User Interface 5 2 0 gt Eclectica Work List Management Eclect Bb New Wet Ci Information S J Programming m Repot Back Next F Home aS Print Preview eS Print oe Work List Report Company ADALTIS S r l Date 01 March 2011 Work List n Eclectica 00092 Author User Instrument sn Eclectica001 Sort by Sample To arrange the Samples in alphabetical order click on the Sample label shown in the red box Fig 7 64 Easy User Interface 5 2 0 gt Eclectica Work List Management Eclectica n0092 gt
59. aterials required to carry out the tests for each method determination of an analyte are indicated in the user instructions in the ECLECTICA Kit Assay Manual code ECLP4050000018 NOTE The information regarding consumable materials given in this Manual is general Carefully read the ECLECTICA Kit Assay Manual code ECLP4050000018 The following consumable materials required to execute assay can be used with the ECLECTICA instrument Common Reagents for Immunochemistry assays reagents required to execute all the applicable assays on the instrument e Systemic Wash Solution Immunoassay Washing Buffer and a pack containing one Substrate Solution one Stop Solution one Separation Reagent and a Smart Card Each pack is sufficient for 200 tests Common Reagents for Clinical Chemistry assays e Systemic Wash Solution Specific Reagents for Immunochemistry assays Specific Reagents for a single assay e A pack containing the Specific Reagents Controls and a Smart Card Each pack is sufficient to execute 100 tests Specific Reagents for Clinical Chemistry assays Specific Reagents for a single assay A pack containing the Specific Reagents and a Smart Card Calibration Set Calibrators reagents to run calibration curves for a single Immunochemistry assay e A pack contains the series of calibrators 5 7 and a Smart Card Calibration Set Calibrators reagents to run calibration curves for a single clinical
60. autions Transport and Storage Installation ECLECTICA User Manual Revision A ECLP4050018V520 Index 1 9 Operation Using Consumables Reagents Use of disposable materials accessories Preparing the Samples Samples Maintenance OPERATIONAL PRECAUTIONG cccccccceeteneeeeeeneeeeeeneeeeeeeeeeseenseesees Operational precautions Types of risks Biological Tisk anosir EEEE Ea E EET EE EE DiS o E E secahuuaunuiralauiawoatoae Chemical risk B OSG OE E E A N A E E A Electrical risk Mechanical risk Risk of lesion Emergency stop procedure SEO MON oee E EEEE LABELLING eres scene center EE Instrument Identification Label Disposal of Electrical and Electronic Waste Label CE Mark Label Safety Warning Labels B 0 2 Mel Ree Ge 0 H e ae en en nn en ee Pe Pee ey aCe Ee ah Fer gr n 2 722116 E ee eT E E nee E Label 33 Moving Parts Hazard cssc a Eaa a OKTET O EE EEE e LOFT D i e E on ee Label 5 Waste Tank Bio Hazard cece ccecccseccsscccssccesccescceusceesceesccesceesceusceessceeceeeeceuscss Label 6 Infection hazard ce cece ccecccsecccscccsccesccusccessccesceesccesccesceescceeceusceeesseusceessceueceuscss Mae Laser Licht Hazardo EAEE ETE E Ea ECLECTICA User Manual Revision A ECLP4050018V520 Index 12 13 13 14 2 9 Layout of labels on the instrument Front view Rear view Rear view Side view SEGON 1 ac ecesa dec ects E EEEE E INSTACCA HON crees E EEEE Er ESA
61. b New Workist oO Information i J Programming g Report Ki Finish Back Next SS Home as Print Preview ag Print Work List Report A Company ADALTIS S r l Date 01 March 2011 Work List n Eclectica 00092 Author User Instrument sn Eclectica001 ECLECTICA User Manual Revision A 7 60 97 ECLP4050018V520 Section 7 Operation End ECLECTICA User Manual ECLP4050018V520 Easy User Interface 5 2 0 gt Eclectica Work List Management Eclecti E New Workist hy Information Programming Report T Finish Finish Finish options g ny Save the Work List is saved for further editing G Build Work List no further editing ready to be RUN Cc al Build and Run Work List no further editing shortcut to RUN bees Menu Pages lt Back Finish Close Fig 7 65 Once the worklist programming procedure is concluded in the Finish page the user can select one of the following three options Fig 7 65 e Save The programmed worklist can be edited and it is not yet displayed in the list of worklists ready to be executed e Build worklist The worklist can no longer be edited It is only executable and it will be displayed in the list of Worklists ready to be executed e Build and Run worklist The worklist is saved built closed and clicking on the Finish button will send you directly to the worklists execution module WLE see next section Ex
62. boratory equipment Emissions The average level of acoustic emissions is below 70 dB A There are no risks concerning gas emissions implosions or explosions of the system s parts Adjustments and Settings The user is not required to set the instrument ECLECTICA User Manual Revision A 10 1 5 ECLP4050018V520 Section 10 Technical Specifications Productivity All mechanical and electronic adjustments must be done by Adaltis technical personnel Time for first immunoassay result from 30 to 90 min depending on scheduled tests Tests per hour after first result e 48 for Immunochemistry e 102 tests for Clinical Chemistry Reagents Controls Calibrators Loading Identification Temperature control ECLECTICA User Manual ECLP4050018V520 Reagents Controls Calibrators dish 20 reagent positions 28 control calibrator positions 4 Reaction Segments each with 24 Cells The bottles are labelled with barcodes Loading of data from Smart Card The reagents dish is kept at a temperature of around 15 C below ambient temperature Revision A 10 2 5 Section 10 Technical Specifications Samples Loading 60 position samples carousel 12 13 mm diameter and 50 100 mm height test tubes Identification The sample barcode identification system is compatible with the following codings Code 128 39 code bar InterLeaved 2 5 UPC EAN Sampling System The sampling system is composed of a magnetic needles
63. ca Work List Management Create or Modify Work Lists for Eclectica Worklist Execution al Eclectica Work List Execution Cc ad ee T ET T POTERE ae Execute Work Lists on Eclectica Data Reduction amp Reporting i Eclectica Data Reduction Perform data reduction for Eclectica sessions Instrument Maintenance Eclectica Maintenance Reagent Inventory Management Reagent Inventory Management for OpenLAB suite Fig 8 1 ECLECTICA User Manual Revision A 8 3 32 ECLP4050018V520 Section 8 Maintenance The OpenLAB software Maintenance Section allows the following procedures to be performed e Daily instrument maintenance e Weekly instrument maintenance e Loading Common Reagents e Changing Reaction Sectors e Checking Blanks e Autozero ECLECTICA User Manual Revision A 8 4 32 ECLP4050018V520 Section 8 Daily Maintenance Startup ECLECTICA User Manual ECLP4050018V520 Maintenance The Daily Start up procedure must be carried out at the start of each work session when the analyzer has been idle for less than 48 hours since the end of the last session Once the type of Start Up has been selected the ECLECTICA analyzer will automatically perform the lines pre flushing and check procedures e AUTOZERO filters and spectrophotometer check e IA blanks check Easy User Interface 5 2 0 gt Eclectica Maintenance gt Daily ed i Daily Start Up procedure Om Repo
64. case no lot relative to the test to be executed is loaded on the analyzer Click on Load from Smart Card to load the relative Smart Card NOTE If a calibration curve and or controls are programmed beforehand directly during programming of the worklist refer to Programming a Worklist a tick symbol will be displayed on the selected option irrespective of the calibration status NOTE For all the tests IA CC execution of calibration checks is optional if a valid even though expired calibration curve exists a mastercurve without any previous check is not a valid curve NOTE Refer to section 4 Calibration method for Immunoassay for further information on management of the calibration curves Press Next gt to go to the Resources ECLECTICA User Manual Revision A 7 66 97 ECLP4050018V520 Section 7 Operation Resources Resource Manager automatically checks the availability of the necessary resources Specific Reagents Controls Calibrators Diluents Common Reagents Wash Solution at the time of execution of the planned tests and provides the user with specific notification messages relative to the problem s encountered if any Fig 7 71 Easy User Interface 5 2 0 gt Eclectica Work List Execution Eclectica auogl P Open Worktst LA Curves amp Resources Run iv Finish v Missing vials on board OK in Warehouse del i E E v Diluent not on board soa aa Vials iim res iu eaea Menu
65. chemistry A pack contains the series of calibrators and a Smart Card Parametric Multicalibrator Reagents for calibrating Clinical Chemistry assays e A pack containing the multicalibrator bottles and a Smart Card Diluents reagents dedicated to groups of analytes for executing sample dilutions Revision A 7 5 97 Section 7 Operation Each pack contains dilution solutions e Each Immunochemistry pack contains 3 bottles 8x20 ml anda Smart Card e Each Clinical Chemistry pack contains 3 bottles 3x50 ml Reaction Segments reaction Cells for running all the assays possible on the instrument e Each pack contains 100 segments NOTE the bottles of Specific Reagents Controls Calibrators and Diluents are provided with labels showing a bar code for positive identification of the bottles on board the instrument by reading the labels themselves with a bar code reader Preparing the Consumable Materials The Common Reagents must be brought up to ambient temperature 18 C 25 C before being loaded onto the ECLECTICA instrument The Specific Reagents Controls and Calibrators can be loaded onto the instrument in the refrigerated reagents dish directly from the refrigerator The Diluents must be at ambient temperature 18 C 25 C before being loaded onto the instrument WARNING Specific Reagents Controls Calibrators and Diluents must not contain foam or bubbles on the surface or inside the liquid
66. cial page Fig 8 6 press Repeat BLANK Fig 8 7 Execube common reagents BLANK running e The window will close when the procedure will be accomplished Fig 8 16 Once the blanks have been checked the values of blanks 1 and 2 on the two cuvettes will be displayed BLANK First value Q Blank valid Second value Repeat BLANK If the error message reappears change the Common Reagents vials after an adequate washing procedure see Replacing Common Reagents in Section 8 Maintenance If the values obtained for Blanks are still outside the limits only Clinical Chemistry tests can be executed ECLECTICA User Manual Revision A 8 24 32 ECLP4050018V520 Section 8 Maintenance Autozero To ensure correct spectrophotometer readings the ECLECTICA analyzer performs a reading test to check operation of the filters The procedure resets the photometer using the wash solution the readings are expressed in 1 10 mV From the Reader Calibration page Fig 8 17 the following procedures can be executed Autozero for Immunoassay amp Clinical Chemistry tests e Autozero for Immunoassay only e Autozero for Clinical Chemistry tests only Press Execute only IA to perform the zero procedure for Immunoassay tests only Fig 8 17 ALTO lr Report 7 Daily 7i Weekly Reader Autozero Saveeenseneeseneneeenssnensennessseeeesensnenssanessnnensnnned Autoz
67. concentration of analyte in the sample the smaller the amount of marked analyte which binds to the antibody marked with the enzyme Fig 4 4 Competitive EIA immunological reaction High concentration sample In some assays the reaction is exchanged since the antibody is marked with FITC and the analyte is conjugated with the alkaline phosphatase Analite Free analyte Analyte marked and free analyte in sample with FITC marked with FITC Sad r gt gt ae E gt bE eer ot m pA gt p gt r ee DE Ka gt gt gt gt ge e a a e gt gt Antibody Antibody marked bound to with enzyme Phase 1 Competition high concentration sample Fig 4 4 Competitive EIA immunological reaction High concentration sample ECLECTICA User Manual Revision A 4 3 17 ECLP4050018V520 Section 4 Operating Principles Phase 2 Magnetic separation ECLECTICA User Manual ECLP4050018V520 At the end of the primary immunological reaction an excess of an anti fluorescein antibody bound to magnetic particles is added which binds rapidly and specifically to the immune complex formed of the analyte marked with FITC the antibody labelled with the enzyme FITC Ag Ab ALP and the analyte labelled with excess and free FITC Fig 4 5 EIA Immunological Reaction Phase 2 Low concentration sample and Fig 4 6 EIA Immunological Reaction Phase 2 High concentration sample These are sedimented with a magnetic field Th
68. ction 8 ECLECTICA User Manual ECLP4050018V520 Maintenance The user must make sure that the ECLECTICA work area is always clean continuous instrument inspection is a decisive factor in assuring good operation of the system any leaks of liquids in the work area are rinsed immediately with distilled water and then dried all waste materials are disposed of in observance of local safety regulations and laws The information on infected liquids given in this manual is followed carefully see Section 1 Safety and Section 2 Labelling Revision A 8 2 32 Section 8 Maintenance Maintenance procedures The following procedures are described hereunder e Instrument Start Up and Shut Down e Wash cycles e Replacement of the consumable materials Common Reagents Reaction Segments Thermal Paper e Disinfection WARNING All maintenance procedures must be implemented in observance of the safety precautions given in Section 1 of this Manual The following maintenance procedures must be done depending on the activity in question at the following periods e daily e weekly e whenever necessary To be effective the maintenance procedures must be run scrupulously at their scheduled times From the Main Menu select the Eclectica Maintenance System icon Fig 8 1 to enter the section reserved for instrument maintenance Easy User Interface 5 2 0 gt Home Page Worklist Management s Eclecti
69. d Clinical Chemistry Wash Solution e replace them with vials of distilled water Load two vials containing distilled water in the CC diluent 1 and diluent positions Fig 8 8 Water CC Diluent Water Diluent 1 position Fig 8 8 NOTE Close the Common Reagents vials disconnected from the analyzer and store them as indicated on their labels Click on OK to start the Distilled Water wash ECLECTICA User Manual Revision A 8 15 32 ECLP4050018V520 Section 8 Maintenance On completion the message Cleaning Procedure Concluded is displayed click on OK Wash with Cleaning Kit NOTE The Cleaning Kit is supplied by Adaltis Srl Do not use any other product for this purpose From the Special page Fig 8 6 press Cleaning Kit wash This opens a confirm dialogue box Fig 8 9 Eclectica Maintenance 1 Replace the Substrate and Stop vials with H S3 Rinse Rinse Solution Replace the lA and the ar slsternic wash solution bottles with Distilled Fr Water Load two vials containing the Cleaning Solution in positions Diluent 1 and Diluent CE i Fig 8 9 e Open the drawer on the right side of the instrument e Undo the Substrate and Stop vial caps e Replace the vials with vials of Rinse Solution e Undo the connection caps on the Immunoassay wash and Clinical Chemistry wash solution bottles and replace them with cleaning solution bottles distilled water e Load two bottles containing
70. d by the software during Resources management WARNING To calibrate a Clinical Chemistry protocol see Curves Section Calibration curve management On termination of the calibration procedure remove the multicalibrator tube from the samples carousel ECLECTICA User Manual Revision A 1 42 97 ECLP4050018V520 Section 7 Operation Loading Diluents The vial of Diluent for Clinical Chemistry tests must be loaded into its well in the outer ring of the Reagents carousel ECLECTICA User Manual Revision A 1 43 97 ECLP4050018V520 Section 7 Operation Loading Common Reagents Wash Solutions The Systemic Wash Solution and Immunoassay Washing Buffer bottles Fig 7 40 must be installed on the instrument as described in Connecting the Waste Tank Accessory Bottles in Section 3 Installation Systemic Wash Solution Bottle Immunoassay Washing Buffer Preparing Storing Using Consumables Refer to the instructions for use for each kit ECLECTICA User Manual Revision A 1 44 97 ECLP4050018V520 Section 7 Operation Programming a Worklist The ECLECTICA OpenLAB software provides the facility to create edit and save worklists to be run From the Main Menu page select the Eclectica Worklist Management icon Fig 7 41 Easy User Interface 5 2 0 Home Page orklist Management Z Eclectica Work List Man nt Create or Modify Work Lists for Eclectica A Eclectica Work List Executio
71. d press Next gt to go to the Information section Opening a saved Worklist Select Archived Worklist The list of the saved worklists is displayed Easy User Interface 5 2 0 gt Eclectica Work List Management F b New Worklist i Information o l Programming E Report _ Create New Work List Archived Work List Backup List of available Panel Filters List of Archived Work List V Finish Documents Remove Name Created Last Modified eclectica 01 03 2011 11 17 01 03 2011 11 17 Details don t want to show this page next time Menu lt Back Next gt Finish Close Fig 7 44 Select the list of interest and press Next gt to go to the specific samples programming section ECLECTICA User Manual Revision A 1 47 97 ECLP4050018V520 Section 7 Operation Information In Information section enter the name of the worklist and press Next to go to the section reserved for programming samples This step is optional because you can skip directly from the worklist selection creation page to the samples programming page Easy User Interface 5 2 0 gt Eclectica Work List Management Edie formatio b New Worklist oO Information A Programming m Report Fa Finish User data Name Eclectica Run 00091 Company JADALTIS S r l Author name User Date 01 March 2011 Description T est i don t want to show this page n
72. d utilising samples and consumables NOTE Carefully read the information on this subject given in the specific users instructions for every assay contained in the Application Protocols Manual p n ECLP4050000018 The following paragraphs describe the precautions and restrictions on use regarding e transport and storage e operation e use of consumables disposable materials e preparation of samples e maintenance Revision A 1 2 14 Section 1 Safety Instructions Transport and Storage Installation Operation ECLECTICA User Manual ECLP4050018V520 The instrument must be transported only in its original packaging supplied by the Manufacturer Adaltis Srl and consisting of a wooden crate Refer to Section 3 Installation and Section 10 Technical Specifications for information about proper storage of the instrument Qualified technical personnel authorized by Adaltis Srl must carry out the installation checking and instrument calibration The qualified technical personnel must make sure that the instruments positioning complies with the environmental and electromagnetic specifications that the instrument s specifications require The instrument may only be moved to a significant extent from one surface to another by qualified personnel The instrument must sit on a flat and perfectly horizontal surface located e away from currents of air e away from direct sunlight and sources of heat Leav
73. ding to the specifications provided in the instructions contained in the ECLECTICA Kit Assay Manual code ECLP4050000018 The ECLECTICA instrument is supplied with a barcode reader that enables positive identification of samples contained in primary test tubes provided with barcode labels The types of barcodes compatible with the reader are given in Section 10 of this manual Technical Specifications If the laboratory does not use test tubes with barcodes the instrument enables positional identification WARNING The bar code label must be located in such a way that the test tube is at least 2 mm away from the edge of the samples carousel Revision A 7 2 97 Section 7 Operation Sample Test Tubes Test tubes having the following characteristics must be used in order for the instrument to operate correctly Type 1 samples carousel 60 positions Diameter 12 13 mm Height 50 100 mm WARNING Using test tubes having specifications other than those indicated could cause problems during the sample _ taking dispensation phases Primary test tubes containing activators on gel or microparticles are advised against Minimum volume of the samples standards Diluting the samples ECLECTICA User Manual ECLP4050018V520 The assays require a specific sample volume in the range from 5ul to 10 ul of sample for each determination This volume does not include the dead volume unusable volume in the sam
74. e Common Reagents vials after an adequate washing procedure see Replacing Common Reagents in Section 8 Maintenance All the filters are out The segment has not Check that the Reaction Segment is in position of range been placed in position 1 1 and that the first 4 reaction Cells are clean If Possible bubble in the OK rerun the Autozero reading Cell If the problem persists contact the Adaltis The reading Cells may Hotline be broken Empty hydraulic circuit Normal lamp deterioration Photometer cells The photometer cells Repeat the Start up procedure temperature error have not reached the If the problem persists contact the Adaltis preset temperatures Hotline Check only Clinical Chemistry tests can be Startup not valid IA autozero error only Repeat the Start up procedure for IA Start Up If the problem persists contact the Adaltis Error on Common Hotline Reagent Blanks only for Immunology Start Up Error on CC and IA autozero only for IA CC Start Up ECLECTICA User Manual Revision A 9 3 9 ECLP4050018V520 Section 9 Troubleshooting Smart Card error malfunction messages Error S d Probablecause _ Message displayed the Smart Card was not Insert the Smart Card correctly ERROR B06 READ inserted correctly Replace the Smart Card CARD ERROR the Smart Card was Call the Adaltis Hotline Service removed from the reader too soon the Smart Card is defective and cannot be read by the Smart Card reade
75. e analyzer for a maximum of two weeks Common Reagents Separation Agent IA Diluents and CC Multicalibrator The container of Separation Agent the Diluents and the Multicalibrator must be removed at the end of the day closed with their caps and stored in a refrigerator at 2 8 C Revision A 8 28 32 Section 8 Maintenance Changing the Thermal Paper Periodically check the amount of thermal paper on the analyzer A red line appears on the paper to show that the roll is almost empty If necessary replace the paper as follows e Press the white button on the right side of the printer door The blue lever on the right side of the printer lifts to indicate that the lock mechanism has been disabled e Open the door remove the old roll and replace it with a new one e Insert the paper in the guide and lower the blue lever so the paper advances e Close the door NOTE If the paper runs out while a WorkList is running the Start page will display the message Printer out of paper In this case the results of the assays will not be automatically printed out on the internal printer However all results from a session can be printed by clicking on Results in the Start page before closing it ECLECTICA User Manual Revision A 8 29 32 ECLP4050018V520 Section 8 Maintenance Disinfection The essential information for disinfecting the instrument properly is given below WARNING read Section 1 Safety carefully befo
76. e data have been loaded the message Remove Smart Card will be displayed After the data have been loaded using the Smart Card the following information relative to the Common Reagents Kit loaded will appear on the Smart Card Viewer page Fig 7 31 ECLECTICA User Manual Revision A 7 31 97 ECLP4050018V520 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 fa Eclectica Smartt ard Viewer 3 z m Package NW Package Code o2 Analyte Analyte Code Common Reagents General Lot j Serial number P0002 Expiry date 237027201 2 Barcode Key ei 4E Available Tests 200 Fig 7 31 e Lot Code e Expiry date e Tests Available e Smart Card serial number and barcode Press OK Fig 7 31 and remove the Smart Card Once the Smart Card has been used it cannot be used again Loading vials containers The vials of Common Reagents substrate and stop solution must be installed on the analyzer as described in Connecting the Waste tank Accessory vials in Section 3 Installation and the container of Separation Agent must be installed at the centre of the Samples Carousel Remove the container of Separation Agent from the package of Common Reagents remove the red cap and place the container in the specific well in the Samples Carousel see Fig 7 32 Revision A 1 32 97 Section 7 Operation Magnetic Separation Container WARNING In order to avoid possible contamination of the reag
77. e quantity of enzyme bound to the magnetic particles is inversely proportional to the quantity of analyte originally present in the sample The excess analyte and the analyte antibody immune complex labelled with the enzyme remaining in solution are eliminated by aspiration and washing Complex with FITC Labelled Free Analyte Analyte and Antibody Bound and Free Reaction Mixture Anti FITC magnetic FITC Labelled Analyte Antibody particles Bound Analyte oo ae Fig 4 5 EIA Immunological Reaction Phase 2 Low concentration sample Free Analyte Complex with FITC Labelled ana rtee i Reaction Mixture Anti FITC magnetic Analyte and Antibody Bound peed te particles FITC Labelled Analyte y o Ei i Bote s be r a e bE F Pec pi S pE gt e Fig 4 6 EIA Immunological Reaction Phase 2 High concentration sample Revision A 4 4 17 Section 4 Operating Principles Washing and separation In both the IEMA and EIA methods the particles sediment and are separated out by a powerful magnet The complexes bound to the magnetic particles are then washed to eliminate excess reagent Phase 3 Enzymatic reaction Colour development Colour measurement ECLECTICA User Manual ECLP4050018V520 Once the magnetic particles have been washed an enzymatic substrate is added to the reaction phenolphthalein monophosphate which results in a resuspension of the particles and initiates the enzymat
78. e required sample Fig 7 54 Remove e Click on the button e Press Yes to confirm deletion of the selected sample Fig 7 54 Er tee bica Wark List Ar Fig 7 54 Entering a sample between two already entered sample IDs e Inthe Code field Fig 7 55 enter the sample ID to be input e Select the line corresponding to the position of the sample required where you want to enter the new sample ID e Press Add gt Insert te a rae poet en ae ov Finish Rename Save Profile as Renaming a sample ID e Select the line corresponding to the sample you wish to rename e Inthe Code field Fig 7 55 enter the new Sample ID e Press Add Rename ECLECTICA User Manual Revision A 1 54 97 ECLP4050018V520 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 Patient Information e Select the row corresponding to the required sample R Patient e Press Patient to input the patient information corresponding to the selected sample fileesa Sas tl be NO SE ads eee nn au WT rake et tc ki ea eee Dpp ee a G a E Information Code 2ois0ov0gs028 Name on s SCS Second name Last name smith s SS Sex Mae gt Date of birth 05 March 1968 Description Descriptior Fig 7 56 Quality control programming e Select the row corresponding to the required sample Fig 7 57 e Press Quali
79. e sufficient free space around the instrument to allow its internal electrical equipment to cool efficiently ensure accurate process area temperature control and leave free access for maintenance Refer to Section 3 Installation and Section 10 Technical Specifications for more information Before installing the instrument the Adaltis technician must ensure that the location of the instrument is compliant with the electrical and environmental safety specifications given in the Section 10 Technical Specifications For correct use of the ECLECTICA instrument make sure to e Connect the instrument to a standards compliant power source NOTE the instrument is designed so as to not be affected by rapid transitory power supply variations e Do not install applications other than those necessary for normal operation of the ECLECTICA instrument on the dedicated PC unless with the express approval of the Adaltis Srl Technical Department Revision A 1 3 14 Section 1 Safety Instructions ECLECTICA User Manual ECLP4050018V520 WARNING Other programs residing in memory such as Power Managers Screen Savers and Antivirus applications may affect the operation of the system and must therefore not be installed Pay specific attention to the instructions provided by the manufacturer for the correct operations used to turn the instrument on and off see Section 7 Operation Do not disconnect the instrument from i
80. eagents must be installed in their sliding drawer on the right side of the instrument next to the waste tank housing as shown in the following figure Fig 3 3 Substrate bottle 5 wa j 7 q Immunoassay eu Systemic wash solution bottle Q a Wash solution l 1 bole ss e i i Stop solution mm bottle ee Fig 3 3 To install the bottles containing the Common Reagents remove their caps and completely remove their aluminium foil covers Connect each bottle to the instrument ring nut cap of the corresponding colour e Yellow ring nut cap for the bottle of Systemic Wash Solution e White ring nut cap for the bottle of Stop Solution white bottle e Black ring nut cap for the bottle of Substrate brown bottle e Green ring nut cap for the bottle of Wash Solution for IA a ECLECTICA User Manual Revision A 3 9 10 ECLP4050018V520 Section 3 First Start Up ECLECTICA User Manual ECLP4050018V520 Installation Launch the software as described in the paragraph Switching on the instrument and launching the software in Section 7 Operation Fit the Reaction Segments as described in the paragraph Change Reaction Segments in Section 8 Maintenance Run washes with the cleaning Kit as described in the paragraph Wash with Cleaning kit in Section 8 Maintenance Now load the Common Reagents as described in the paragra
81. eatment instructions can yield incorrect results The sample volume necessary for executing the assay may vary based on the analyte to be determined Consult the specific User Instructions for every assay contained in the Application Protocols Manual p n ECLP4050000018 and Section 7 of this manual Operation for information about the sample volume Taking and processing samples ECLECTICA User Manual ECLP4050018V520 The following recommendations for handling and storing blood samples were provided by the National Committee for Clinical Laboratory Standards NCCLS Doc H18 A e Take the blood samples following the normal precautions for collecting biological fluids e In the case of serum samples allow the samples to adequately and fully coagulate before centrifuging them NOTE In order to avoid incorrect results due to the presence of fibrin make sure the coagulation process is complete before the samples are centrifuged Some samples particularly those of patients undergoing therapy with anticoagulants may require a longer time for coagulation e The test tubes must be kept closed and in a vertical position e Do not use samples that have been left at ambient temperature for more than 8 hours e Hermetically seal and refrigerate the samples 2 C 8 C if the assay is not made within 8 hours e Freeze the samples at 20 or below if the assay is not performed within 48 hours e Thaw the samples only once and t
82. ect the tests for which you require an assessment of the results in the Test list Easy User Interface 5 2 0 gt Eclectica Data Reduction Eclectica 000S4 gt Readings f z Select Session Information Unit Measure io Readings m Report Finish Description Position ee Sector 41 HCG HCG Qual Sector D Sector D Sector D a I don t want to show this page next time T Menu Pages Back Next Finish Close Fig 7 89 ECLECTICA User Manual Revision A 7 85 97 ECLP4050018V520 Section 7 Operation Reports The report relative to the worklist executed Fig 7 90 shows an index with the list of the evaluated tests Easy User Interface 5 2 0 gt Eclectica Data Reduction Eclectica 00094 gt Report o Information i Unit Measure m Readings m _ Report Back Next T Home eed Print Preview eS Print x Select Session Ti Finish Session Report Session Eclectica 00094 Built Date 01 March 2011 Print Date 02 March 2011 09 27 Report by Sample Methods list z Menu Pages Back Next gt Finish Close Fig 7 90 Two types of report can be selected e Report by single method e Report by patient e All reports shows the reports for all the programmed methods in the same window scroll down to see them ECLECTICA User Manual Revision A 7 86 97 ECLP4050018V520 Section 7 Operation Report by single method ECLECTICA User Manual ECLP4050018V52
83. ecution of a worklist Revision A 7 61 97 Section 7 Operation Executing a Worklist ECLECTICA User Manual ECLP4050018V520 The OpenLAB ECLECTICA management envisages processing of the resources required for execution of the programmed worklist uploading and subsequent execution of the worklist From the Main Menu page press the Eclectica Worklist Execution icon Fig 7 66 Easy User Interface 5 2 0 gt Home Page Worklist Management Eclectica Work List Man ent Create or Modify Work Lists for Eclectica Worklist Execution Eclectica Work List Execution Execute Work Lists on Eclectica Eclectica Data Reduction Perform data reduction for Eclectica sessions Instrument Maintenance Eclectica Maintenance Maintenance operation for Eclectica instrument Management amp Tools Reagent Inventory Management Reagent Inventory Management for OpenLAB suite x Menu Fig 7 66 Revision A 7 62 97 Section 7 Operation Selection of the worklist to be executed In the Open WorkList page Fig 7 67 select the following options e Execute a pending worklist e Execute a programmed and saved workilist Easy User Interface 5 2 0 gt Eclectica Work List Execution b Open Worklist e Curves e Resources a Run i Finish Documents l Pending Work Lists Programmed Work Lists Backup Partially executed Work Lists with gj Ready to run
84. ed number that follows the housing it refers to clockwise The refrigeration system is controlled by the switch on the rear of the instrument see Section 7 Operation This system keeps the temperature around 15 C below ambient temperature ECLECTICA User Manual Revision A 5 3 14 ECLP4050018V520 Section 5 Functions NOTE The instrument is now equipped with a refrigeration system ON led Fig 5 2 Make sure that the refrigerator is ON green led if the reagents are left onboard the instrument Reagent plate Refrigerator led ECLECTICA User Manual Revision A 5 4 14 ECLP4050018V520 Section 5 Samples Carousel Incubation System ECLECTICA User Manual ECLP4050018V520 Functions The samples carousel Fig 5 3 is on the right of the instrument s Work Area Standard installation envisages a samples carousel with 60 positions able to house test tubes of size 12x 50 mm 100 mm Each carousel numbers the samples in a counter clockwise sequence in two rows from 1 to 30 and from 31 to 60 for the 60 position dish The identifying numbers are silk screened on Each number is printed in advance of its respective position The positions which are user programmable can also be used for Clinical Chemistry calibrators Fig 5 3 The samples carousel also features e 5 positions for the Diluent bottles used on the ECLECTICA system for immunochemistry assays e One position for the Separation Agen
85. edure Click on No to abort the procedure Revision A 8 21 32 Section 8 Filling the Hydraulic Circuits ECLECTICA User Manual ECLP4050018V520 Maintenance From the Special page Fig 8 6 press Execute Prime Fig 8 16 to fill the hydraulic circuits A window will open containing the following message Sennen reagents ii gt The prime procedure of the Substrate and the d S Stop will invalidate the Start Up Press OK to Continue al JY Press OK to start the filling procedure Subsequently it will be necessary to launch the start up procedure see Daily Maintenance and Weekly Maintenance in this section Revision A 8 22 32 Section 8 Maintenance Replacement of Reaction Sectors ECLECTICA User Manual ECLP4050018V520 From the Special page Fig 8 6 select the sector 1 4 corresponding to the sector to replace Fig 8 14 After selecting the sector the Samples Carousel rotates to make the sector in which the selected segment is to be installed available to the user YD Confirm segment change tepu Yez Mo Fig 8 14 Press Yes to confirm Fit the Reaction Segments into the relevant wells as shown in Fig 8 15 Fig 8 15 Revision A 8 23 32 Section 8 Maintenance Checking Blanks If the values of Blanks 1 and 2 fall outside the required limits between 1 and 150 mOD repeat the Blanks execution procedure for the immunoassay test From the Spe
86. ents do not place the vial caps on the work surface when they are removed The caps can be reused WARNING Before using the analyzer make sure that the red cap on the Separating Agent container has been removed thereby avoiding collision with the Sampling Needles Once the vials of Substrate and Stop Solution and the Separation Agent container have been installed carry out the procedure for replacement of Common Reagents described in Section 8 Replacing Common Reagents Loading the Wash Solution The bottles of Systemic Wash Solution and Immunoasaay Washing Buffer must be installed on the instrument as described in Connecting the Waste Tank Accessory bottles in Section 3 Installation ECLECTICA User Manual Revision A 7 33 97 ECLP4050018V520 Section 7 Operation Package 03 Diluents kit The methods used to upload data and install Diluent bottles are described below Data upload Open the package of Diluents and remove the Smart Card Manas Smart Card Press Eclectica Smart Card Load Material on the bar at the top right Fig 7 27 A window will appear displaying the message Insert Smart Card Insert the Smart Card in the reader Insert the Smart Card with the writing facing upwards and the chip facing the instrument Wait for the red light on the reader to go out When the data have been loaded the message Remove Smart Card will be displayed After the data have been loaded using
87. er Manual Revision A 7 76 97 ECLP4050018V520 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 During execution of the worklist the Execution page will update the following in real time by means of information provided in specific fields e tests status programmed not programmed reaction cell not available running completed test results obtained absorbance and concentration values of Blanks 1 and 2 IA Execution errors if present Unit of measurement The details relative to the individual test selected are shown in the Details box at the top right of the page Details Control Ce beethiod HCG Status Phase 1 Elapsed 00 01 37 Residual 00 41 56 Uh m lUl The reaction segments are shown at the bottom of the page cells that cannot be used are shaded To replace segments simply click on the relative symbol and follow the instructions Click on the right of the segments representation to open the menu shown in the following screenshot Nl 7 Check Volumes SF Paper Feed Ey This menu provides the facility to perform the operations specified in the following table Revision A T 1197 Section 7 Operation Command Description Check Volumes Provides the facility to manage the volumes check of the components loaded on board Paper Feed Feeds the paper of the internal printer Close Closes the menu NOTE during execution of the worklist the test results obtained are printed aut
88. ero results 03 03 2011 10 33 Confirmed v Wave length Old value New value Evaluation 650 12360 Valid 0 14 Walid 340 9862 Valid 340 10302 Walid 405 12200 Valid 405 12108 Valid 492 12112 Valid 492 12133 Valid 546 13716 Valid 600 13660 Valid 650 12021 Valid Execute all Execute only 14 Execute only Ce A B B B B B B B B B B Immunology 0 546 492 0 546 492 Menu Close Fig 8 17 This displays the message Are you sure to execute the calibration for immunology filters Select Yes the instrument will perform the photometer autozero procedure ECLECTICA User Manual Revision A 8 25 32 ECLP4050018V520 Section 8 ECLECTICA User Manual ECLP4050018V520 Maintenance On termination of this procedure if the values obtained are higher than 8 500 a green tick symbol will be displayed ge rgside the reading values of the reference filters and a message will indicate that the analyzer is ready for operation Fig 8 17 The values of the Clinical Chemistry methods are displayed at the top of the window the Immunoassay ones at the bottom If the values are lower than 8 500 a yellow tick symbol will be displayed alongside the reading values of the reference filters The system is ready for operation but it is advisable to contact the Adaltis Hotline Service since the photometer lamp may be at the end of its service life If the values are between 7 500 and 8 500 the system
89. es and Controls the If the curve is rejected again The message appears in the saved curve is execute a standardization routine Remark field of the Execution rejected because it is Report incongruent with the Re run the Controls worklist If the Control values curve saved in the memory is Remark During a worklist rejected again proceed as i including only described in point 3 Crv Rejected Controls the saved curve is rejected because it is 3 Re run the standardization worklist incongruent with the Control values 3 During a standardization Re run the worklist N routine the curve is not accepted Curve accepted Crv 1 The calibration check Accepted performed by means of the two controls is in The message appears in the compliance with all the Remark field of the Execution acceptability criteria Report in correspondence with the controls and calibrators 2 During a standardization routine the curve has been Remak aoe Cry Accepted ECLECTICA User Manual Revision A 9 7 9 ECLP4050018V520 S ection 9 Troubleshootin INVALID TEST The Controls or the 1 Run again the controls standards standards were not within 24 hours accepted for a new kit lot number TEMPORARY RESULT The software used an 2 Run or re run the old expired calibration controls standards within 24 hours to get results TEST CONFIRMED The controls standards 3 No action have been run re run within 24 hours from the
90. ext time Menu Pages lt Back Next gt Finish Close Fig 7 45 In this page you can e Enter edit the name of the worklist e Edit the worklist author s name e Enter comments and or descriptions ECLECTICA User Manual Revision A 7 48 97 ECLP4050018V520 Section 7 Operation Samples Programming The Programming section provides the facility to perform the following operations e Entering samples e Programming the tests to be performed on samples e Entering patient information e Quality Control programming e Automatic samples identification e Managing lists from LIS this function allows to recover previously executed programming as well NOTE It s possible to access the Programming tab skipping all the revious steps New Worklist gt Information The software will create an empty worklist anyway Easy User Interface 5 2 0 gt Eclectica Work List Management E yy F New Workist oO Information Programming Report a Finish Code From To C X Remove B Patient LLS Barcode we rP v otis Test HP 9 85 Ht Samples CURVES controis do Menu Pages lt Back Next gt Finish Close Fig 7 46 samples Input Enter the name of the sample in the Code field and press Add Fig 7 47 If you want to identify the samples with the same name and a sequential number enter the first number in the From field and the l
91. faction attained regarding the Training Course The user shall be kindly asked to fill in an evaluation questionnaire provided by Adaltis Customer Care at the time of installation ECLECTICA User Manual Revision A 11 3 3 ECLP4050018V520
92. foe lt t lt t w co Time sec Fig 4 17 Kinetic reaction Two Reagents ECLECTICA User Manual Revision A 4 16 17 ECLP4050018V520 Section 4 Operating Principles Fixed Time ECLECTICA User Manual ECLP4050018V520 This type of reaction is generally used in enzymatic and chemical reactions and measures the variation of absorbance over a set time The variation of absorbance over a set time is not generally linear Calculation After reading in the visible spectrum after a set time for both the sample and the standard Example AA min sample Standard Concentration of Creatinin _ Concentration in the sample mg dL of Creatinin AA min standard mg dL WARNING Refer to the User instructions given in the Application Protocols Manual p n ECLP4050000018 for further information on Clinical Chemistry assays Revision A 4 17 17 Section 5 Functions SECTION 5 FUNCTIONS Purpose ECLECTICA Fig 5 1 is a closed system that uses dedicated reagents The assays that can be run automatically with the ECLECTICA instrument are described in the ECLECTICA Assay Manual code ECLP4050000018 The ECLECTICA instrument automatically performs all assay operations except for preparation of the samples Fig 5 1 WARNING In some countries use of the instrument may require for running certain of the assays for which it is designed the approval of or registration with Governmental Agenc
93. g even minimal amounts of the target analyte Some concentrations of analyte produce such a strong colour that they cannot be measured directly at this wavelength Such solutions can be measured accurately at 492 nm The data processing system of the ECLECTICA instrument enables measurements to be made at both wavelengths Spectrophotometric Reading System ECLECTICA User Manual ECLP4050018V520 A spectrophotometer carries out the spectrophotometric reading The spectrophotometer is provided with a halogen lamp whose light passes through one of the 9 interference filters which can be selected using an internal microprocessor The measurement chain is shown in the following diagram Fig 4 8 TELELTET ie Receiver Amplification Selective filter and focal system Analogic Section Digital Section Fig 4 8 Revision A 4 6 17 Section 4 Operating Principles Data processing and results Standardization ECLECTICA User Manual ECLP4050018V520 The colour absorption is proportional to the concentration of substance available to react in the antigen antibody reaction Fig 4 9 Concentration vs signal Comparing the absorption with that produced by a known amount of the substance in question allows us to determine its concentration in the sample dao Aysuag paydo 5Parameters IU ml Fig 4 9 Concentration vs signal A series of known concentrations are a
94. has been handled abnormally during transport If this is the case or if the packaging is damaged but the SHOCKWATCH has not tripped or is missing proceed as follows e Do not refuse the shipment e Detail the problem in writing e Do not remove the instrument from its packing and immediately request inspection to be done by the forwarding company within 15 days from receipt If the shipment is international inspection must be requested within 3 days from receipt e Inform the Adaltis Hotline Service NOTE The procedure described above may vary with local regulations and or with specific agreements made with the forwarding company Revision A 3 2 10 Section 3 Storage Information Provided Materials Consumable Materials ECLECTICA User Manual ECLP4050018V520 Installation In order to store the instrument properly it is advisable to keep it in a dry room and to comply with the environmental requirements given in Section 10 Environmental Requirements for Storage The instrument must be stored only in its original packaging Only specialised personnel may perform storage operations Refer to the User Instructions for every single analyte contained in the Application Protocols Manual p n ECLP4050000018 with regards to the storage consumable materials The following materials are supplied with the instrument divided into e Consumables Disposable Materials e Optional materials e Materials supplied with the
95. hat periodic visual inspection of the instrument is the first and easiest way of ensuring the best performance of the instrument To ensure correct maintenance carefully read the instructions given in Section 8 Maintenance and in particular e use only the recommended wash and disinfecting solutions with the proper concentration e periodically clean the instrument parts according to the methods described e Immediately remove any splashes or leaks of liquid from the work area Revision A 1 7 14 Section 1 Safety Instructions WARNING Before cleaning or decontaminating the equipment using methods other than the ones recommended by the manufacturer contact Adaltis Srl to check that the proposed procedure does not risk damaging the instrument ECLECTICA User Manual Revision A 1 8 14 ECLP4050018V520 Section 1 Safety Instructions Operational precautions The precautions and restrictions regarding the consumables reagents and samples to be used with the ECLECTICA instrument are described in this Section WARNING All reagents provided with the ECLECTICA instrument are for professional use only They must be used only by expert laboratory personnel in conformity with GLP rules Do not combine reagents from different lots Operational precautions e Do not pipette with your mouth e Do not smoke eat or apply cosmetics in those areas where the kit s reagents are handled e Avoid inoculation contaminati
96. he Shut Down procedure Emptying the Waste Discharge Tank see Emptying the Waste Discharge Tank The Waste Tank must be emptied at the end of each work session At the end of each working day e remove all of the sample test tubes from the Samples Carousel e remove the container of Separation Agent from the Samples Carousel close it and store it in a refrigerator at 2 8 C e check that there are no leaks of liquid or spills in the work area if necessary clean as instructed in Disinfecting the work area For storing Reagents see Storing consumables on board the instrument From the Daily page press the Execute Shut down Execute Shut Dowen This displays the message Revision A 8 7 32 Section 8 Maintenance Eclectica Maintenance Ci the instrument Remove the systemic wash solution and replace it with the distilled water The daily shut down include a wash cycle of Follow the instructions and click on OK the analyzer automatically performs a wash cycle of e sampling needles e reaction cuvettes wash needles e flow cells and reading system needles using distilled water On termination the following message appears L L Eclectica Maintenance 1 ar 5 Shut Down procedure completed Please Empty the Waste Tank to continue Click on OK Empty out the Waste Discharge Tank Another message appears ECLECTICA User Manual Revision A 8 8 32 ECLP405001
97. horoughly mix after thawing e Use of an ultracentrifuge is recommended for clarifying the lipaemic samples Revision A 1 6 14 Section 1 Safety Instructions Serum Plasma Volume Maintenance ECLECTICA User Manual ECLP4050018V520 NOTE Haemolysed samples may indicate unsuitable processing of the sample prior to its arrival at the laboratory the results must be interpreted with circumspection for this reason Collect 5 ml of venous blood in a glass test tube without additives Have it coagulate at ambient temperature 18 C 25 C Centrifuge separate the fraction consisting of the serum and store Collect 5 ml of venous blood in a test tube made of glass or plastic containing Heparin as an anticoagulant Centrifuge separate the fraction consisting of the plasma and store on WARNING Before loading the sample into the ECLECTICA system make sure that it is free of particles suspensions filaments clots fibrin air bubbles and foam The volume of the sample is specified in the user Instructions for each individual assay This volume does not include the dead volume unusable volume in the sample container or the additional volume required for executing replicates or other tests to be run on the same sample The user must perform the daily and weekly maintenance procedures pursuant to the instructions given in Section 8 Maintenance throughout the instrument s lifetime The manufacturer reminds you t
98. i aaraa nsei Shut Down Procedure ccccccccssscccceseccceeeccceeseccceecceseneceeseessseeeeseeneeees QUALITY CONTROL ace cme cca ee kesene n ESEE KA RENERE EASE RAEN General Description Terminology Quality 6 OMUEON csse aa A ETE a MO sa iahauiebuncecdacdeee lersasamettans tietaadanadendiesenniasantaacdens Standard DC AIO a soserst aces orssascie ches e EESTE Coefficient of Variation CV sssssscscxsissecoerssessactanansusaeseetarsewennssaerectansevadioua s Quality Control Directives How to select a control SCLUM ccccceccececceccceccccceccecsccscececcecsecceseeees When torun gua hiy COMO sissien a ADDITIONAL FUNCTIONS ccc cceeeeeeeeeeeeeeeeseeeeeeneeeeaes OpenLAB Options Reagent Controls Calibrator barcodes Immunology Methods cccccccccccsssssssseseeeeeeceeeeeeeeeeaaaaseeeseeeeeceeeeeeeeeeeaaas Clinical Chemistry Methods ccccssssssssseeeeceeeeeceeeeeeasesessseseeeseeeeeeeeeeeaaas Type of Reagent Control Calibrator 0 cccccccccsssssssseeseeeeeeceeeeeeseeeeenaaas Clinical chemistry multicalibrators Barcode keys cccscceeeeeeeeeeeeeeees SECTION Geaa E EE MAINTENANCE rerin General Rules Maintenance procedures ECLECTICA User Manual Revision A ECLP4050018V520 6 9 Daily Maintenance UAE UTD AAAA E A E AE EA E E E E EE E E E E A For storing Reagents see Storing consumables on board the instrument Shutdown siincnca sacsaeve
99. ials see the list in Section 3 Consumables disposable materials except for the Reaction Segments diuents and wash solutions come with Smart Cards that allow the test data specific lots to be automatically loaded All of the bottles containing the Specific Reagents Controls Calibrators and Diluents have barcodes so they can be positively recognised once loaded on the instrument Revision A 5 2 14 Section 5 Functions Description of subsystems The ECLECTICA instrument consists of the following functional subsystems e Work Area e Barcode reader identification system e Sampling Specific Reagent Control Calibrator Diluents and Separation Reagent system e Magnetic Separation System e Reaction cuvettes wash system e Common Reagents sampling system e Reading system e Management Software These subsystems are described in the following paragraphs Work Area The area contains e Reagents dish e Samples carousel e Reaction Segments Section and Incubation System Reagents Dish This dish Fig 5 2 located on the left side of the Work Area is divided into two crowns both refrigerated with Pelletier effect and numbered counter clockwise with e 28 positions to house Calibrators and Immunochemistry Controls outer crown e 20 positions for Immunochemistry and Clinical Chemistry Specific Reagents inner crown e 1 position for the Clinical Chemistry diluent Each position is identified by a mill
100. ic reaction The enzyme alkaline phosphatase in the immune complex bound to the magnetic particles removes the phosphate group of the substrate thus producing phenolphthalein in direct proportion to the quantity of enzyme present On completion of incubation the enzymatic reaction is stopped by adding a Stop Solution which turns the phenolphthalein pink The intensity of the colour is directly proportional to the concentration of analyte present in the sample in the IEMA method and inversely proportional to it in the IEA method In IEMA methods a stronger colour indicates a higher concentration of analyte in the sample In IEA methods a stronger colour indicates a lower concentration of analyte in the sample Once the stop solution has been added and the colour developed the magnetic particles are sedimented with a powerful magnet at the side of the reaction Cell The clear coloured solution is ready for aspiration into the flow microcell for photometric reading of the base wavelength of 546 nm at which the phenolphthalein Fig 4 7 Phenolphthalein absorption spectrum has maximum absorption and at the wavelength of 492 nm where the absorption is around a quarter of that at the base wavelength Revision A 4 5 17 S ection 4 Operating Principles BLUE GREEN YELLOW Absorbance Wavelength nm Tog Fig 4 7 Phenolphthalein absorption spectrum The base measurement at 546 nm yields a high sensitivity thus revealin
101. ies The ECLECTICA system is intended for use in in vitro diagnostics Ivo ECLECTICA User Manual Revision A 5 1 14 ECLP4050018V520 Section 5 Functions Description of functions ECLECTICA User Manual ECLP4050018V520 The ECLECTICA instrument provides the following functions as given in the Application Protocols for the assays e Sampling of the biological samples e Sampling of the Reagents e Incubation at 37 C e Magnetic separation e Wash after separation e Photometric reading e Processing and printout of the results The ECLECTICA system has the following characteristics HARDWARE The system has the following principal functions e It enables positive identification of the samples and reagents by reading their barcodes e t determines the presence of the samples reagents to be dispensed by means of a level sensor e t dispenses the samples e It enables easy loading by Smart Card of the information regarding the lot of reagents used on the instrument e It quickly reads the absorbance by means of a photometry station SOFTWARE The software consists of an easy to use management system that enables interactive communication between user and instrument Additional software characteristics are e Easy access to the menus through the interface with Touch Screen e Easy step by step programming e Processing and printout of the results CONSUMABLE MATERIALS All Consumable Mater
102. instrument In order for the instrument to be properly used only consumable materials manufactured and supplied exclusively by the manufacturer Adaltis Srl or by its dealers intended specifically for use on the ECLECTICA instrument may be used In particular the following products are considered consumable materials IMMUNOLOGY CONSUMABLES Common Reagents Reagents required to run all assays e A package containing one Substrate Solution one Stop Solution one Separation Agent and a Smart Card e A package of Systemic Wash Solution and Immunoassay Washing Buffer Specific Reagents Reagents required to run a specific assay e Each package contains the Specific Reagents Controls and the Smart Card on which are stored the specific data for the analyte to be assayed Calibration Set calibrators Reagents required for running the Calibration Curve for a given assay e Each pack contains the set of calibrators 5 7 necessary to execute a calibration curve and a Smart Card containing the necessary data Revision A 3 3 10 Section 3 ECLECTICA User Manual ECLP4050018V520 Installation Diluents Reagents required for diluting the sample where required e Each package contains dilution solutions and a Smart Card CLINICAL CHEMISTRY Common Reagents Reagents required to run all assays e A package of Systemic Wash Solution Please note that even if you are not running IA tests the Immunoassay Wash So
103. ised dealer may bring about incorrect results Patients undergoing treatment with monoclonal antibodies Mouse whether for diagnostic or therapeutic purposes may have developed anti mouse antibodies HAMA The presence of HAMA in the sample may generate both false positive high and negative low values in systems using monoclonal antibodies Samples containing HAMA coming from these patients should not be assayed in the ECLECTICA system Interpreting the assay results ECLECTICA User Manual ECLP4050018V520 For diagnostic purposes the results obtained from each assay must always be used in combination with the clinical examination the patient s anamnesis and other laboratory investigations Revision A 6 1 1 Section 7 Operation SECTION 7 OPERATION Preparation for operation Samples Type of Samples Preparing the Samples ECLECTICA User Manual ECLP4050018V520 The information necessary for using the ECLECTICA instrument correctly is given in the following paragraphs NOTE the information regarding handling the Consumable Materials is general it is therefore advisable to read the instructions contained in the ECLECTICA Assay Manual code ECLP4050000018 Safety Recommendations Carefully read Section 1 Safety and Section 6 Operating Precautions and follow the rules therein in order to reduce risks relating to use of the instrument Personnel assigned to operating the instrument
104. ision A 7 57 97 ECLP4050018V520 Section 7 Operation JobList information Name Eclectica 00091 Test Date 01 03 2017 15 54 16 HCG_500 From Eclectica Work List Management BCE 1 HCG_100 1 To Reread last programmed Sample P a ure Aan Samples Sample ID Tests SE STS SSS SSE Select all SMP HCG_500 HCG_100 HCG_10 HCG_1 TSH_1 sea SMP2 HCG_1 TSH_1 Unselect all SMP3 HCG_1 TSH_1 Fig 7 63 The Joblist information box Fig 7 63 gives general information on the worklist to import and the total number of tests programmed in it The Samples box shows the samples and tests programmed in the worklist to be imported A tick is displayed on the samples programmed in the current worklist The tick is not shown for samples that are not programmed in the current worklist WARNING In the case of acquisition from barcodes it is important to perform automatic samples identification before uploading the worklist ECLECTICA User Manual Revision A 7 58 97 ECLP4050018V520 Section 7 Operation Report of the programmed worklist The Report section display a detailed report of the programmed worklist Fig 7 64 Easy User Interface 5 2 0 gt Eclectica Work List Management Eclectic 1092 gt Re ji New Worktst X Information Programming g Repot ye Finish Back Next F Home aS Print Preview aS Print e A Work List Report Company ADALTIS S r l D
105. ive to the Multicalibrator will appear on the Smart Card Viewer page Fig 7 38 Revision A 7 40 97 Section 7 Operation rt P Iz o I Eclectica SmartCard iewer ipi Package f Package Code o7 a Analyte Analyte Code MultiParametric Cali m General Calibrators Meth Code Conc Meth Code Conc Meth Code Conc r Lot ALP 445 GGT 33 fo fo w Serial number T0004 er mo ee pe ooo ooo m Expiry date 307067201 1 am fies 33 RN RON fies 33 o oo a Barcode Key 3674 ast 35 500 LDH_P 502 Available Tests po perc frsao Pos faoen TBIL 5 140 TPROT 5 050 ca 3 860 TRIG 140 CHOL 150 UREA 39 ck 313 URICA 5 410 CREA 3 660 fo fo e im ipe fe Fig 7 38 e Method Code e Lot Code e Expiry date e Tests Available e Smart Card serial number and barcode e Concentration values for each analyte in the calibrator Press OK Fig 7 38 and remove the Smart Card Once the Smart Card has been used it cannot be used again Preparing and loading the Parametric Multicalibrator Open the Parametric Multicalibrator package and remove one of the multicalibrator vials Reconstitute the material as per the Instructions for Use Pour the contents of the vial into a sample tube and place it in the Samples Carousel Fig 7 39 ECLECTICA User Manual Revision A 7 41 97 ECLP4050018V520 Section 7 Operation WARNING The position of the Parametric Multicalibrator sample tube is establishe
106. kages do not pour the reagents into previously used containers do not mix reagents from different lots e Observe the instructions for preparing using and storing the consumables given in the assay User Instructions in the Application Protocols Manual p n ECLP4050000018 e Observe the restrictions of use given in the instructions for every assay contained in the Application Protocols Manual p n ECLP4050000018 e Contact the Adaltis Hotline Service if you receive packages of consumable materials not shipped in compliance with the given specifications Use of disposable materials accessories ECLECTICA User Manual ECLP4050018V520 The disposable materials supplied by the Manufacturer Adaltis Srl are the Reaction Segments reaction cells These are disposable plastic containers in which all assay phases except photometric reading are run Each package contains 100 segments of 24 Cells each 2400 reaction Cells NOTE Do not reuse or substitute disposable materials All disposable materials are to be sheltered from dust and sources of heat Revision A 1 5 14 Section 1 Safety Instructions Preparing the Samples Samples Consult the User Instructions for every assay contained in the Application Protocols Manual p n ECLP4050000018 in order to determine the correct type of sample for each assay and the respective handling and storing methods WARNING Failure to observe the sample selection and tr
107. lculated from a number of calibration curves derived from different instruments The parameters for the curve are stored on the Smart Card supplied with each pack of Specific Reagents The number of master curve calibrators depends on the analyte in question see the User Instructions of each single assay The calculation method used for processing the data includes the two previously described mathematical models 4 and 5 parameter The design of the ECLECTICA instrument and the stability of its reagents make it unnecessary to run a daily curve The characteristics of the instrument which make the creation of a daily curve unnecessary are the following e repeatable dispensing e precision timing e accurate temperature control e stability of reagents Instead of analyzing all the calibrators to register a curve standard calibration the user need only load the Smart Card supplied with the package of Specific Reagents into the system The master curve cannot be used as it is to evaluate samples it becomes suitable for this only after the 2 points verification see below Two point verification The master curve enables the user to register a curve which while specific to the assay in question is not necessarily suited to the characteristics of the system The user must therefore analyse the two Controls supplied with each pack of Specific Reagents Control 1 C1 and Control 2 C2 The two Controls once run will yield abso
108. low Cells located in front of the wash system manifold in the reaction Cells e Fig 5 10 Fig 5 10 e Two peristaltic pumps e Two flow Cells located in a housing to the right of the samples carousel e Fig 5 11 e A spectrophotometer the light emitted by the halogen lamp passes through interference filters mounted on a wheel which is microprocessor controlled to select the filter to match the type of reading required by the method in question the specifications of the filters are given in Section 10 Technical Specifications ECLECTICA User Manual Revision A 5 13 14 ECLP4050018V520 Section 5 Management Software ECLECTICA User Manual ECLP4050018V520 Functions The solution to be measured is drawn up for spectrophotometry by the peristaltic pumps into the flow Cells and then discharged into the waste tank The flow Cells are washed after each reading with wash solution which is dispensed into the first four cuvettes of the first Reaction Segment Fig 5 11 The software of the ECLECTICA instrument works with the Windows XP Home Edition operating system lts multitasking structure allows the user to move from one menu to another to monitor the instrument s operation and status without interfering with any processes that may be in progress Revision A 5 14 14 Section 6 Restrictions on Assays SECTION 6 RESTRICTIONS This Section describes the restrictions to be observed when running assa
109. ls The ECLECTICA instrument is equipped with an internal thermal matrix printer that provides a standard printout of the results It is possible to request an external printer provided with USB lead for customized printouts Materials supplied with the instrument Each instrument is equipped with 1 Waste tank e 1 bottle for Systemic Wash Solution e 1 brown bottle for washing the Substrate line e 1 white bottle for washing the Stop Solution line e 1 bottle for IA Washing Buffer Also supplied with every instrument is a box containing e 1 Touch Screen Pen e 1 Mouse duplicator e 1 package of Adaptor for sample tubes 65 pieces e 1 roll of thermal paper for the internal thermal printer e 1 pack of Reaction Segments 24 segments e 1220 Volt Electric Power Cord e 1115 Volt Electric Power Cord e 1 System recovery Disk CD e 1 ECLECTICA software installation CD e 1 CD containing the user manual in the available languages e 1 Kit of Tubes e 1 Kit of Fuses Each instrument is supplied with e 1 User Manual instrument User Instructions e 1 Instruction Manual for using ECLECTICA Kits containing the User Instructions for every single analyte ECLECTICA User Manual Revision A 3 6 10 ECLP4050018V520 Section 3 Installation Installation Correct installation assures good operation of the instrument The installation must be done by technicians authorized to do so by Adaltis Srl The installatio
110. lt Cale Pass 5 Session Eclectica 00091 completed J Date 2011 03 01T16 35 02 Run Status Cuvette1 4 001 Cuvette2 4 002 ga No tests to process a G Meru Pages lt Back Next gt Finish Close Fig 7 83 FY 2 65 28 03 2010 Revision A 7 80 97 Section 7 Operation Execution end ECLECTICA User Manual ECLP4050018V520 In the Finish section Fig 7 84 the following options are possible e Select Accept and save results to save and display the worklist in the list of sessions executed in the section Viewing and printing the results for a worklist e The second option makes it possible to launch the results processing plug in data reduction immediately 5 a a ET aire ated Eea Easy User Interface 5 2 0 gt Eclectica Work List Execution Eclec Fh nae Open Worklist i Curves e Resources Run iv Finish Finish Finish options G al Accept and save results bes CHN Accept results and start Data Reduction immediately eS Menu Pages Finish Close Fig 7 84 NOTE if at least one of the tests associated with one or more samples is not performed during execution of a worklist the user can leave the tests controls in the current pending list which after re processing will result in execution of only those tests controls that were not completed previously For all tests associated with
111. ltiple ring because the usable reaction cells on J segments are not enough to contain the scheduled tests fall 5 z mlU ml z 7 At the end of the first portion the following message will appear Run 1 completed J Please change the Reaction Segments to procede with the nest run After replacing the segments with a new set you can resume execution of the worklist The meaning of the symbols beside each test sample during the run is Oh Sample test waiting for execution Sample test being executed O Sample to be executed in the second portion of the list g Sample test successfully executed Revision A T 179 97 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 When worklist execution has been completed the execution end message will be displayed Fig 7 83 ne ose ee ee ce a Open Werkist Curves o Resources 9 lt Run Ei Finish ED c1 TSH STD 1 23 0338 Calc Pass ulU ml E c1 TsH STD 2 30 0340 Calc Pass ulmi Details Control Ci ED c2TsH STD 1 3 32500 UpdPa ulmi Method TSH Phase Test Completed c21sH sto Eclectica Work List Execution 0 SMP1 HCG_1 500 SMP QC E SMP1 HCG_1 100 SMP QC D SMP1 HCG_1 10 SMP 0C SMP1 HCG 1 1 SMP QC E SMP2HCG1 1 SMP SMP3HCG_1 1 SMP E smpt tst_a 1 SMP QC SMP2TSH_1 1 SMP SMP3 TSH1 1 SMP Elapsed 00 05 07 Residual 00 00 00 OD 0 336 Uhd ulU ml Resu
112. lution Bottles has to be replaced with a distilled water one Specific Reagents Reagents required to run a specific Clinical Chemistry e Every package contains the Specific Reagents and a Smart Card with the data for the analyte in question Parametric Multicalibrators e Each package contains the multicalibrator bottles and a Smart Card with the corresponding reference values Refer to Section 7 Reagent Control Calibrator barcodes for more information about the analytes contained in the multicalibrator Calibration Set calibrators Reagents required for running the Calibration Curve for a given analyte e Each pack contains the set of calibrators necessary to execute a calibration curve and a Smart Card containing the necessary data Diluent Reagent required for diluting the sample always required for the reagent blank Revision A 3 4 10 Section 3 Other consumables ECLECTICA User Manual ECLP4050018V520 Installation For correct use of ECLECTICA consumables e Do not use other consumables than those specified by Adaltis Srl All consumables must be used within their specified expiry dates e Use the consumables in their original packages do not pour the reagents into previously used containers Do not mix reagents from different lots e Observe the instructions for preparation use and storage of the consumables given in the dosage User Instructions in the ECLECTICA Assay Manual code EC
113. ms PAO Ela ForPackaqdind Y as Print Preview aS Print G Kit Info yp Eclectica Smart Card Material Load Reagent Inventory Management Recurrent queries Specific Reagents Calibrators 3 Common Reagents 3 Diluents Calibrators Kits immunology HCG 000 29 02 2012 4 Menu Fig 7 23 Select Check expired lot Fig 7 23 to check also the packages of the selected component for which the lot has expired KIT INFO Through the Kit Info button Fig 7 24 it s possible Fig 7 25 1 to display the available lots for the relevant analyte Analyte Code Lot 2 to display the number of available tests for each lot Available tests 3 to delete the selected lot Delete Lot 4 to decrease the number of available tests for the selected lot Update tests ECLECTICA User Manual Revision A 7 25 97 ECLP4050018V520 Section 7 Operation ecurr Select Calibration Kit ts Calibrate a Reagents ue Select Common Ragents Kit Select Diluents Kit Multicalibrators Specific Reagents Kits Specific Reagent Kit All Calibrators Kits pst All Common Reagents Kit Fig 7 24 Jl Avaris Fig 7 25 ECLECTICA User Manual Revision A 7 26 97 ECLP4050018V520 Section 7 Operation Curves The curves page Fig 7 26 displays the status of the lots relative to the reagents uploaded to the warehouse Easy User Interface 5 2 0 gt Reagent Inventory Manageme
114. must have good familiarity with the good laboratory practices GLP particularly with reference to In Vitro analyses IVD WARNING As well as having a detailed knowledge of this manual the user must attend a specific course authorised by the manufacturer Adaltis Srl Carefully read the information given hereunder and the more specific information contained in the ECLECTICA Assay Manual code ECLP4050000018 referring to the analytes to be assayed for correct utilisation of the samples The samples that can be used with the ECLECTICA instrument are serum plasma urine or other biological fluids carefully read the section concerning every assay given in the ECLECTICA Assay Manual code ECLP4050000018 Before being used the samples must be taken to ambient temperature Moreover they must be free of particles suspensions filaments clots fibrin foam or bubbles that could make their dispensation difficult NOTE The information given in this manual regarding the samples is general It is therefore advisable to read the instructions for use contained in the ECLECTICA Assay Manual code ECLP4050000018 Revision A 7 1 97 Section 7 Operation Storing the samples Identifying the Samples ECLECTICA User Manual ECLP4050018V520 WARNING Incorrect preparation of the samples may produce inaccurate and unreliable results In order to prevent alteration of the samples store them accor
115. n e Execute Work Lists on Eclectica Data Reduction amp Reporting Eclectica Data Reduction l Perform data reduction for Eclectica sessions Instrument Maintenance 4 Eclectica Maintenance Maintenance operation for Eclectica instrument Management amp Tools _ Reagent Inventory Man ent Reagent Inventory Management for OpenLAB suite Menu Fig 7 41 ECLECTICA User Manual Revision A 7 45 97 ECLP4050018V520 Section 7 Operation New Worklist The panels that can be executed on the instrument are shown in the centre of the page Easy User Interface 5 2 0 gt Eclectica Work List Management b New Worklist oO Information Z Programming m Report Ki Finish amp Archived Work List Backup List of Archived Work List O Name Created LastModified Description NE eclectica 01 03 2011 11 17 01 03 2011 11 17 betas don t want to show this page next time Menu Poses lt Back Next gt Finish Close Fig 7 42 For details on the methods included in each panel select the panel and press Details Fig 7 43 b New Worklist oO Information Z Programming m Report Ki Finish Docume Dialog Box 0 x A zi Menu Pages lt Back Next gt Finish Close Fig 7 43 Click on OK or Cancel Fig 7 43 ECLECTICA User Manual Revision A 7 46 97 ECLP4050018V520 Section 7 Operation Select Create a new worklist Fig 7 45 an
116. n procedure is described in the following paragraphs Detailed safety instructions are given in Section 1 Safety and Section 2 Labelling WARNING If the instrument has to be moved to a new position or office after installation contact the Adaltis Srl Hotline Unpacking Use a crosshead screwdriver to undo the bolts securing the side panels then lift off the packaging and remove the two side panels securing the instrument Take out the box containing the materials supplied with the instrument At least two people are necessary to move the instrument from its wooden base to the work table Place the instrument on the work surface where the instrument will have to operate Check that the serial number of the instrument corresponds to the one on the transportation document if it does not contact the Adaltis Srl Hotline NOTE Store the original packing in case you want to store or move the instrument in the future Electrical Connections The instrument comes with a three wire three pole Bulgin F power cable for 230 V AC power supply The power cable must be connected to a wall plug with ground terminal The power supply plug has two 3 15 A protection fuses WARNING In accordance with the safety regulations listed at the beginning of this manual the instrument must be connected to an earth point in order to reduce the risk of electric shock ECLECTICA User Manual Revision A 3 7 10 ECLP4050018V520 Section 3
117. nantanusdeweent asanioaahdsononatianesieantaatianaedoanauaansoanesstladabie asiadanosatiaaunieaauasantegesaeteamesnetemantantes Weekly Maintenance DS UBUD EEEE TEE ETE TETTETETT ATE ETE T T E TET ELEELE O OAA DEERE AA E TEA AEE E EA EE ATE Special Wash with distilled Water essssssssssssssssssssssssssssssssssssssssssaseseeseeseeseeseeeseeeeeeeeeeeaeeeeeaeeeeeaeees Wash with Cleaning Kit cccscesssssssseeccceececeeeecaaesesssseseeeececeeeeeeeeeaauaeassuseeeeeeeeeeeeeeeeeaaaaagaegaess Sampling Needles Wash escceviwstsaastevcases swaddduadaiacdosdewietebadta ionendendehuutenvouePeantanasieed ussemacddesdavessendanions Emptying the Waste Discharge Tank cccccccccccccccsssssssessseeeeececeeeeeeeeeaaaasessssseeeeeeeeeeeeeeeeeeaaaas Replacing and Loading Common Reagent ccccccccsssssssssseseeeeceeeeeeeeeeeaaaaaaeesseeeeeeeeeeseeeeeenaaas Filling the Hydraulic Circuits ccccccccceeccccccececceeaaeeeesesseseeeceeececeeeeeeeeeeaaaaaaessseeeeeeeeeeeeeeeeeaaaas Replacement of Reaction Sectors cccccccccccccccccceceeesensessesseseeeeccceeeeeeeeeeeaaeaaussseeeeeeeeeeeeeeeeeaaaas Dee gt e PT T T E sewer sed tanto NE T E E teen AA pat pelea N NT A E E sc ap E E E E E E E E EE T EAEE Cleaning External cleaning of the barcode readen nieri e a EE Eaa External cleaning of needles and work afea ssisoriisessreirisinedreriiaeaiina an Ee aK eaa Storing consumables on board the instrument Changing the Thermal Pape
118. nd install the Distilled Water vials Press OK Now run a Distilled Water wash ECLECTICA User Manual Revision A 8 18 32 ECLP4050018V520 Section 8 Maintenance Emptying the Waste Discharge Tank ECLECTICA User Manual ECLP4050018V520 NOTE Empty the Waste Tank at the end of every working day If the waste tank fills up during a session the session will terminate The waste tank has a capacity of around 1700 ml When the Waste Tank needs emptying the User is notified by a message From the Special page Fig 8 6 Special press Empty Waste Tank This opens a confirm dialogue box Have you emptied the Waste Tank Fig 8 12 pannen reagents oo MR ectica Maintenance 1 h J Have you emptied the waste tank Fig 8 12 Empty the Waste Tank and press OK Revision A 8 19 32 Section 8 Maintenance Replacing and Loading Common Reagents ECLECTICA User Manual ECLP4050018V520 Replace the Common Reagents as follows Keep Common Reagents Substrate Stop Separation Agent at room temperature for 30 minutes before installing them on the analyzer NOTE All Common Reagents Substrate Stop Separation Agent must be replaced at the same time Open the door on the right side of the instrument unscrew the probe caps on the individual vials and remove the vials from the reagents drawer The Separation Agent must be removed from the centre of the Samples Carousel run a Cleaning Ki
119. nt gt Curves ies ae pd Print See Print Preview Kye Eclectica Smart Card Material Load sce aati v SI AH Available tests 100 Calibration Expiry Date Action to perform Calibration Controls M Calibration F E v mangled amd Available tests 100 Calibration Expiry Date Action to perform Calibration Controls 7 Calibration Menu Close Fig 7 26 The symbol indicates that the kit is valid and can be used although a calibration check is required Further possibilities include Indicates that kit and calibration are both valid The Curves page is automatically updated by loading the Smart Card relative to the specific reagent ECLECTICA User Manual Revision A 7 27 97 ECLP4050018V520 Section 7 Operation Uploading Data from Smart Card Press Load Material Fig 7 27 on the bar at the top right A message is displayed prompting the user to insert the Smart Card Fig 7 2 7 For more details please read the following pages smart Lard reading Package 01 Specific Reagents Kit upload The methods used to upload data and install vials of Specific Reagents and Controls are described below Data upload Open the package of Specific Reagents and remove the Smart Card Fig 7 28 Fig 7 28 Press Eclectica Smart Card Load Material on the bar at the top right Fig 7 27 ECLECTICA User Manual Revision A 7 28 97 ECLP4050018V520 Section 7 Operation A window will appear displaying
120. nt Maintenance A Eclectica Maintenance Maintenance operation for Eclectica instrument Management amp Tools R nt Inventory Management di Reagent Inventory Management for OpenLAB v Ei r Fig 7 8 Revision A 7 16 97 Section 7 Operation How to display the Status Bar ECLECTICA User Manual ECLP4050018V520 Select the Menu gt Options button and uncheck the Show Status Bar option Fig 7 9 to hide the status bar Show Navigation Bar Show Title Bar Show Status Bar Setting Options Abou Fig 7 9 The screenshot Fig 7 10 shows the appearance of the main menu with the status bar Easy User Interface 5 2 0 gt Home Page Worklist Management Eclectica Work List Man nt Create or Modify Work Lists for Eclectica Worklist Execution A Eclectica Work List Execution e Execute Work Lists on Eclectica Data Reduction amp Reporting Eclectica Data Reduction Perform data reduction for Eclectica sessions Instrument Maintenance Management amp Tools Eclectica Maintenance Maintenance operation for Eclectica instrument R Inventory Man ent Reagent Inventory Management for OpenLAB suite ol Ki Fig 7 10 Revision A 7 17 97 Section 7 Operation Repositioning the side menu navigation bar Select the side menu navigation bar in the dotted area shown by the red box in the following screenshot Fig 7 11 and move
121. of human fluids based on chemical or biochemical methods It is one of the three major disciplines applied and Microbiology in medical laboratory work along with Haematology The biological fluids on which measurements are made are serum plasma urine cerebrospinal fluid in exceptional cases pleural pericardial and peritoneal or sinovial fluids may be used In Clinical Chemistry three major groups of analytes are measured e Substrates Glucose Nitrogen Cholesterol etc These are known molecules which upon addition of the reagents produces a measurable colour Their concentration is represented by the ratio of the colour developed by the sample to that obtained from the reference standard e Enzymes GOT AST GPT ALT CPK etc These are molecules which act on the reagent and vary its extinction value The delta extinction measured over a standard period of time is proportional to the concentration It is usually read in UV at 340 365 A because the AE is obtained from the action of the enzyme on a NAD NADH system e Electrolytes The most common method used for these measurements is spectrophotometry Types of reaction The chemical reactions can be classified into three main groups e End Point e Kinetic e Fixed Time ECLECTICA User Manual Revision A 4 12 17 ECLP4050018V520 Section 4 Operating Principles End Point reactions ECLECTICA User Manual ECLP4050018V520 End Point reacti
122. omatically using the internal printer installed in the instrument NOTE you can abort execution of the current worklist at any time by pressing the Stop button Fig 7 82 which is displayed in red during execution Easy User Interface 5 2 0 gt Eclectica Work List Execution Eclectica au0g1 Run r Open Workist e Curves e Resources Ay Run iv Finish Tet Kind Repi Pos OD Resut_ UM Time Remark Be Stop G c1 TsH E x umi a AD c1 1sH STD e s ulU ml Detats Control C1 iD c2tsH STD ul ml Method TSH Phase Test Scheduled M c2 TSH STD lt umi Elapsed 00 00 31 p Residual 01 30 40 OD SMP1 HCG_1 500 SMP QC miU ml UM lum lt i SMP1 HCG_1 100 SMP QC i mlU ml LD SMP1 HCG_1 10 SMP QC 5 i mlU ml SMP1 HCG_1 1 SMP QC mlU ml LI SMP2 HCG_1 1 SMP s miUum i nantais 0D SMP3 HCG_1 1 SMP s i miU ml Cuvettel D00 p Cuvette2 0 002 0D SMP1 TSH_1 1 SMP QC ull ml I SMP2 TSH_1 1 ull l Running 0D SMP3 TSH_1 1 ui ml Dituent Sample phase B ii iin iin a Menu Pages lt Back Next gt Fig 7 82 If the list is divided into several runs at the beginning of the first portion of the list the following message is displayed ECLECTICA User Manual Revision A 7 78 97 ECLP4050018V520 S ection 7 ECLECTICA User Manual ECLP4050018V520 Operation The current Work List will be divided in mu
123. on human biological fluid samples Main functions identified by specific icons on the left of the screen Fig 7 3 Easy User Interface 5 2 0 gt Home Page Worklist Management l Eclectica Work List Man ent Create or Modify Work Lists for Eclectica Worklist Execution A Eclectica Work Li ecuti e Execute Work Lists on Eclectica Data Reduction amp Reporting clectica Data ion i Perform data reduction for Eclectica sessions instrument Maintenance A Eclectica Maintenance Maintenance operation for Eclectica instrument Management amp Tools Inventory M ent Reagent Inventory Management for OpenLAB suite Menu Fig 7 3 ECLECTICA User Manual Revision A 7 11 97 ECLP4050018V520 Section 7 Operation Icons on the left side of the screen Worklist Management Eclectica Work List Management Create or Modify Work Lists for Eclectica Worklist Execution oi Eclectica Work List Execution e Shea g Execute Work Lists on Eclectica Data Reduction amp Reporting g Eclectica Data Reduction eduction for Eclectica sessions Management amp Tools Reagent Inventory Management Reagent Inventory Management for OpenLAB suite Instrument Maintenance Eclectica Maintenance Maintenance operation for Eclectica instrument worklists Management WLM Used to create edit and save worklists worklist Execution WLE Used to execute worklists that ha
124. on of mucous membranes or the formation of aerosol e Laboratory gloves must be worn when handling the patients samples or liquid or solid wastes Types of risks The following paragraphs describe the various types of risk associated with the use of the ECLECTICA instrument and the relative safety instructions e Biological risk e Chemical risk e Electrical risk e Mechanical risk e Risk of lesion The instrument is equipped with labels to identify the positions and types of the various hazards For further details refer to Section 2 Labelling Biological risk Analysis of the immunological assays increases the risk of exposure to potentially infected substances For the sake of safety it is necessary to meticulously observe the rules for handling samples and reagents of human origin Adaltis Srl reminds you that ECLECTICA User Manual Revision A 1 9 14 ECLP4050018V520 Section 1 Safety Instructions ECLECTICA User Manual ECLP4050018V520 e using the instrument does not rule out exposure to the risk of contamination so the instrument must always be considered potentially infected e all parts of the instrument that may come into contact with blood serum and other biological fluids reagents and Controls must be handled as potentially infected materials e all waste materials must be handled as though they are potentially infected The manufacturer Adaltis Srl also assumes that all precautions and w
125. ons Fig 4 14 End Point reaction single reagent are the classical reactions used to measure the concentration of substrates They can be enzymatic reactions in equilibrium due to the complete exhaustion of the analyte e g formation of a complex of the analyte with a specific kelating substance Calculation Reading in the visible spectrum after termination of the reaction with production of stable colour The reaction may involve one or two reagents Example OD SAMPLE Standard Concentration of calcium miesanie mgd X Concentration p g OD STANDARD mg dL where OD SAMPLE optical density of sample OD STANDARD optical density of standard Standard concentration known concentration of reference standard 0 4 I l l l l l 0 3 4 H l l I l l l l l l in I 2 0 2 4 H l l I l l l l l I l l l l l L 0 1 l l l l l l l l I I l l 0 Time sec Fig 4 14 End Point reaction single reagent Revision A 4 13 17 Section 4 Operating Principles ECLECTICA User Manual ECLP4050018V520 The above graph Fig 4 14 End Point reaction two reagents shows a typical End Point reaction after a certain period of time depending on the concentration of the enzyme the temperature the type of reagent etc the reaction reaches equilibrium and the colour remains stable for a variable period of time minutes to hours
126. orts etc About The About button is used to obtain information on the OpenLAB version Exit To close OpenLAB software 7 13 97 Section 7 Operation Easy User Interface layout personalization Click on the Menu and Pages buttons at the bottom left of each page to change the software layout Fig 7 4 Easy User Interface 5 2 0 gt Eclectica Work List Management 7a B New Worklist oO Information Documents l Programming E Report _ Create New Work List Archived Work List Backup List of available Panel Filters List of Archived Work List V Finish Name Created Last Modified eee eclectica 01 03 2011 11 17 01 03 2011 11 17 Details don t want to show this page next time I Menu Pages Next gt Finish Close Fig 7 4 The following instructions describe how to e Hide the menu navigation bar e Hide the Title bar e Hide the status bar e Move the menu lateral navigation bar e Hide the module tab pages ECLECTICA User Manual Revision A 7 14 97 ECLP4050018V520 Section 7 Operation Display the Navigation bar ECLECTICA User Manual ECLP4050018V520 Select the Menu gt Options button and check the Show Navigation Bar option Fig 7 5 to enable the side navigation bar display Show Navigation Bar Show Title Bar Show Status Bar Setting Options Abouk Fig 7 5 Figure Fig 7 6 shows the
127. pensing needles the washing head the flow cells aspiration needles and the flow cells themselves For the procedure see below From the Weekly page press the Execute Shut down Execute Shut Dowen This displays the messages Replace the Substrate and Stop vials with H 53 Rinse Rinse Solution Replace the lA and the wae J svsteric wash solution bottles with Distilled Ji Water Load two viale containing the Cleaning Solution in positions Diluent 1 and Diluent CE i Replace the liquids as per instrument s instructions and then click Ok the instrument will automatically perform the washing with cleaning kit procedure see Washing with cleaning kit in this Section the wash cycle will clean e sampling needles e reaction cuvettes wash needles e flow cells and reading system needles After the first part of the procedure has been completed the following message will appear Revision A 8 11 32 Section 8 Maintenance Eclectica Maintenance 0 Remove the Rinse solution vials and load i A distilled water Bottles Remove the cleaning re solution and load two bottles of distilled water in position Diluent 1 and diluent CE Replace the liquids as above and click on OK On termination the following messages appear a SS SS Eclectica Maintenance 1 E an 5 J Shut Down procedure completed Please Empty the Waste Tank to continue Eclectica Maintenance 4 2 A Please now
128. petition Parameter b The slope of the straight section on the logit log transform In other words the slope of the curve Parameter c The intercept of the logit log transform horizontal displacement of the curve in other words the position of the median point relative to the concentration of analyte Parameter d The lower asymptote is the minimum colour density In an IEMA method this corresponds to a blank or base measurement without analyte in an EIA method it corresponds to the anlyte s saturation point Parameter s the asymmetry of the curve This parameter is typically set to 1 when the curve assumes a perfectly symmetrical S The 4 parameter equation contains 4 factors which are constant for each lot of reagent Revision A 4 8 17 Section 4 Operating Principles ECLECTICA User Manual ECLP4050018V520 _ a d_ 1 x c Fig 4 13 4 Parameter equation Parameter a the expected response for a zero assay parameter b the slope of the logit log relation multiplied by 1 Parameter c indicates the assay corresponding to the expected response halfway between a and d Parameter d corresponds to the expected response for an infinite assay Revision A 4 9 17 Section 4 Operating Principles Immunology calibration method ECLECTICA User Manual ECLP4050018V520 The ECLECTICA calibration uses a master curve and a two point verification procedure Master curve The master curve is ca
129. ph Common Reagent replacement in Section 8 Maintenance Execute the Start Up Procedure as described in Section 8 Maintenance Revision A 3 10 10 Section 4 Operating Principles SECTION 4 OPERATING PRINCIPLES In the following we describe the principles on which the immunoenzymatic clinical chemistry and specific protein methods used on the ECLECTICA are based Principle of immunoenzymatic assays The ECLECTICA uses a well tested immunoreaction scheme based on immunoassays with magnetic particles The separation method is so versatile that it is applicable to all types of molecules from apthens like steroids to large molecules using different assay schemes IEMA and EIA with the same separation reagent The large surface area of the magnetic particles provides both high sensitivity and a wide range of linearity Direct Immunoenzymetric Assay IEMA Phases 1 and 2 Phase 1 Immunochemical reaction The direct sandwich method uses two antibodies Ab1 and Ab2 which are specially selected and specific against two distinct antigenic determinants of the same antigen In this method see Fig 4 1 Immunological reaction in the IEMA assay the immunological reagent is composed of a mixture of two antibodies one conjugated with FITC Ab1 FITC and the other with the enzyme ALP Ab2 ALP During primary incubation the two conjugated antibodies bind simultaneously to the analyte in two different positions
130. ple container or the additional volume required for executing replicates or other tests to be run on the same sample So the minimum volume of the samples necessary for executing the assay consists of the dead volume plus the volume of sample liquid necessary for executing the analytic assays e dead volume is 200 ul e the minimum sample volume is given in the instructions for using every single analyte see ECLECTICA Kit Assay Manual code ECLP4050000018 e the minimum standard volume is given in the instructions for using every single analyte see ECLECTICA Kit Assay Manual code ECLP4050000018 If required by the assay the ECLECTICA instrument performs pre dilution of the samples Samples with concentrations higher than the analytic range can be assayed following dilution with the specific Diluent Automatic dilutions may be made directly by the ECLECTICA instrument The bottle of Diluent specified in the instructions for use contained in the ECLECTICA Kit Assay Manual code ECLP4050000018 must be Revision A 7 3 97 Section 7 Operation placed in the specific position on the ECLECTICA instrument sample carousel Alternatively dilutions can be carried out manually before loading the samples onto the instrument ECLECTICA User Manual Revision A 7 4 97 ECLP4050018V520 Section 7 Operation Consumable Materials ECLECTICA User Manual ECLP4050018V520 The Consumable M
131. possible controls that are found to be outside the limits of acceptability it will also be possible to calculate the result after repeating and accepting the controls within the following 24 hour period For correct management of partially executed worklists see Management of partially executed lists in this Section Revision A 7 81 97 Section 7 Operation Viewing and printing the results of a worklist ECLECTICA User Manual ECLP4050018V520 The OpenLAB ECLECTICA software allows the test results of an executed worklist to be displayed and printed Press the Eclectica Data Reduction icon on the Main Menu page to enter the section reserved for results processing and printing Easy User Interface 5 2 0 gt Home Page Worklist Management l ny Eclectica Work List Management Create or Modify Work Lists for Eclectica Worklist Execution 4 Eclectica Work List Execution Execute Work Lists on Eclectica Data Reduction amp Reporting hl Eclectica Data Reduction Perform data reduction for Eclectica sessions strume Eclectica Maintenance 4 Maintenance operation for Eclectica instrument Management amp Tools Reagent Inventory Management al Reagent Inventory Management for OpenLAB suite s f Fig 7 85 Revision A 7 82 97 Section 7 Operation Selecting a Worklist The Select Session section Fig 7 86 allows the user to print the results of both saved workli
132. r Disinfection DPismtecine the Work Afeeri niineronno doin iN EAE E UENEN ASE EE OEN Disinfecting the metallic Meedles sssanissnirersinsesiiansivasananeniioniranninsen aiaa ana inanin Disinfecting the waste tank s c csscccccsanccscassaecsaesdaonsagenhesacesgacasenesecasesgacacndandwangnnsaaniadanieapimmianeaimeags SEGUON G EEEE TROUBLESHOOTIN Toese EE EEEE EREE exer Generic error malfunction messages Smart Card error malfunction messages Barcode reader error malfunction messages Worklist loading error malfunction messages Assay execution error malfunction messages Invalid test results Competences SECTION IO races pee esissee ee nce ee ewe gem ee ome se com ane eeeceeecceneenecens TECHNICAL SPECIFICA HONS iccescciswcessciencesnazeusoseanecesnaceceswctneaeeecisueee ECLECTICA User Manual Revision A ECLP4050018V520 Dimensions and Weight Electric Requirements Power Consumption Environmental Requirements for Operation Environmental Requirements for Storage Electromagnetic Compatibility Safety Emissions Adjustments and Settings Productivity Reagents Controls Calibrators Loading Identification Temperature control Samples Loading Identification Sampling System Incubation Dish Photometric Reading Volume of liquid waste produced Immunology wash LIS interface Characteristics of the software Hardware specifications INN rss detects detect dee ter E se eeeneeeeeeeeaeeeen eee SUPPLEMENTARY INFORMATI
133. r Message displayed The card has already been Use a new Smart Card ERROR B02 CARD read NOT VALID ALREADY USED Message displayed There is a problem with the Inform the Adaltis Hotline Service error in Smart Card Smart Card reader driver driver A02 Barcode reader error malfunction messages Error S d Probablecause ___ The barcode reader The barcode reader lens Clean the barcode reader lens with a soft cloth does not read the may be dirty and distilled water Repeat the scanning vial barcode or The vial labels may be procedure reads it only partially damaged If necessary manually enter the barcode printed on the vials label as described in Section 7 Composition of Reagent Controls Calibrator barcodes Worklist loading error malfunction messages Error _________ Possible cause _ Error The number Worklist has more methods Eliminate several methods of reagents methods or reagents than can be exceeds the processed capacity of the analyzer ECLECTICA User Manual Revision A 9 4 9 ECLP4050018V520 Section 9 Troubleshooting Assay execution error malfunction messages Error s Possiblecause Message displayed The waste tank is full Click on Stop and save the worklist with the tests Waste tank full Ok executed up to the time of the error The list will be marked as not executed or partially executed and displayed under pending lists Displays the The
134. r than the available number of reaction cells the list will be divided into several runs although it will continue to be a single list Easy User Interface 5 2 0 gt Eclectica Work List Execution Eclecticag 00091 gt Run Open Worklist el Curves e Resources Run iv Finish Tet ied Regt Pos 00 Rent UM Time a 0 c1 TSH STD 1 ulmi 0 C1 TSH STD 2 wo ull l OD c2 sH STD 1 31 ull ml iets ghee M c2 TSH STD 2 3 ull nl Elapsed 00 08 28 Residual 30 40 0 SMP1 HCG_1 500 SMP QC 1 13 mlU ml uae tae LID SMP1 HCG_1 100 SMP QC 1 14 roll ral 00 SMP1 HCG_1 10 SMP QC 1 15 mlU ml AID SMP1 HCG_1 1 SMP QC 1 16 mlU ml 0 SMP2 HCG_1 1 SMP 1 W a miU ml Run Status 0 SMP3 HCG_1 1 SMP 1 22 mlU ral mina Sah OD SMP1 TSH_1 1 SMPC 1 Fe ulrl a i SMP2 TSH_1 1 SMP 1 38 ull ml dd SMP3 TSH_1 1 SMP 1 39 ull ml a Ready to Start TTT ALO Fig 7 81 WARNING On entering the page the software performs an automatic volumes check with the level sensor of diluents CC calibrators and specific reagents only if contained in multiple vials Any anomalies are indicated to the user by suitable messages that will assist in solving the relative problem WARNING Before pressing Run make sure the 4 Reaction Segments have been inserted in the specific wells For the procedure for inserting the Reaction Segments see Changing the Reaction Segments in Section 8 Maintenance ECLECTICA Us
135. rbance for comparison with the reference values on the instrument Valid Curve If the verification run with the two Controls conforms to all acceptability criteria the calibration curve is classified as valid for the current batch of Specific Reagent Frequency of verification with the two Controls The Eclectica system requires verification of the calibration for each assay whenever Revision A 4 10 17 Section 4 Operating Principles e The calibration verification deadline expires the period of validity of the calibration is analyte dependent ranging from 2 to 4 weeks refer to the assay User Instructions for further information e The Specific Reagent lot number changes e The Common Reagent lot number changes e The Quality Control serum values are out of tolerance e The instrument is serviced Standard calibration standardization If necessary the user may run a standard calibration of the system using the calibrators supplied in the Calibration Kit The IA standardization once performed does not require to be validated through C1 and C2 until the expiry date of the standardization itself 2 4 weeks analyte dependant ECLECTICA User Manual Revision A 4 11 17 ECLP4050018V520 Section 4 Operating Principles Principle of Clinical Chemistry Assays Clinical Chemistry Determinations Clinical Chemistry or Clinical Biochemistry are generic terms which commonly cover the majority of quantitative analyses
136. re servicing the analyzer Certain maintenance activities should be carried out only when wearing coveralls with long sleeves having elastic band cuffs hard wearing rubber gloves and protective goggles Disinfecting operations must be performed using two sodium hypochlorite solutions commercial hypochlorite at concentrations of 1 and 0 5 Commercial hypochlorite usually has a 5 25 concentration in this case prepare the solutions as follows e Solution A approx 1 200 ml of hypochlorite and 800 ml of deionised water e Solution B approx 0 5 100 ml of hypochlorite and 900 ml of deionised water WARNING The treatment recommended in this Section does not ensure that the instrument becomes sterile i e that all of the viruses and microorganisms are completely inactive but it minimises the risk of contamination WARNING Before using any disinfecting method other than the one recommended by the manufacturer the user must check with the manufacturer that the proposed methods will not damage the instrument WARNING Make sure the analyzer has been switched off main switch OFF O symbol and the power cable has been disconnected ECLECTICA User Manual Revision A 8 30 32 ECLP4050018V520 Section 8 Disinfecting the Work Area Disinfecting the metallic needles Disinfecting the waste tank ECLECTICA User Manual ECLP4050018V520 Maintenance Dampen all surfaces showing traces of deposits of contaminating liquids wi
137. ring Select the ring you wish to acquire reagents or controls and then click on the Scan button at the top left of the screen fig 7 73 The following pop up window will appear e g in the case of reagents JOpentaB suite 1 z The barcode reader is starting on Reagents rack Are you sure ae Fig 7 73 Click on Yes and wait for the automatic procedure to terminate ECLECTICA User Manual Revision A 7 68 97 ECLP4050018V520 Section 7 Operation Manually Left click on the required position of the ring of controls or reagents and select the operation to be performed from among those displayed by the popup window that is displayed Fig 7 75 and following T Resources Management xi y Scan Samples moving to 13 Left Right W y Reagents Calibrators and Contrals Samples and Diluents Name i Position Method Lot Available units Fig 7 74 Loading reagents T Resources Management n x Scan Samples moving to 25 Left Right Reagents Calibrators and Controls samples and Diterts Name Position Method Lot Available units All vials All vials Fig 7 75 Loading controls ECLECTICA User Manual Revision A 7 69 97 ECLP4050018V520 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 Once loading procedures are completed the contents of each position can be specified by clicking on it with the left mouse but
138. rt T l Weekly Special O Reader Autozero w Daily IA CC Start Up valid Daily 1A Start Up valid On completion of l the Start up Execute Shut Down tw Daily Shut Down is net vaia Procedure a green tick symbol will be displayed M Shut Down procedure Menu Fig 8 2 It is possible to perform a complete start up procedure or a limited procedure for Immunoassay tests On completion of the start up procedure the execution end message will be displayed Fig 8 3 indicating whether or not the instrument is ready for tests Revision A 8 5 32 Section 8 Maintenance Fig 8 3 Press Show Details Fig 8 4 for further details on the result of the Start Up procedure executed on the analyzer e Blanks e Check of operation on the filters utilised e IA Start up Procedure Result e CC Start Up Procedure Result 2 Shut down weekly Fig 8 4 ECLECTICA User Manual Revision A 8 6 32 ECLP4050018V520 Section 8 Shutdown ECLECTICA User Manual ECLP4050018V520 Maintenance WARNING if the instrument is switched off after the Start Up the entire procedure must be repeated Shut Down to be run whenever the analyzer is to be switched off see Shut Down NOTE if the analyzer is not used for more than 48 hours the software will prompt the user to perform a washing procedure with the Cleaning Kit see Wash with Cleaning Kit before running t
139. rted for dilution starting from position 60 A WARNING To avoid damages it s VERY important A N to load sample empty tubes where required by the software ECLECTICA User Manual Revision A 1 73 97 ECLP4050018V520 Section 7 Operation Loading Diluents Load the bottles of Diluent in the special wells located at the centre of the Samples Carousel left clicking the mouse on the required Samples Carousel position and selecting Load gt dil Scan Samples moving to 1 y eT Right w Qx Reagents Calibrators and Controls Samples and Diluents ProgrammedTests ExecutableTests Fig 7 79 Select Ok to continue ECLECTICA User Manual Revision A 1 14 97 ECLP4050018V520 Section 7 Operation Automatic samples identification Click on SamplePlate tab select one position on the sample carousel and then click on the Scan button Fig 7 80 for automatic identification of the samples loaded on the samples plate Fig 7 80 Loading Common Reagents Refer to Section 8 Maintenance Replacing and Loading the Common Reagents ECLECTICA User Manual Revision A 7 75 97 ECLP4050018V520 Section 7 Operation Run The Run page Fig 7 81 will display the list of tests to be executed and indicate the estimated execution times for individual tests and for the entire worklist If the number of tests to be executed is highe
140. se than archiving with the express authorization of Adaltis Srl is forbidden The sample printouts screenshots and the graphics contained in this Manual are intended purely as illustrations information and as graphics Adaltis Srl provides no guarantee regarding the accuracy or reliability of the information given in the said printouts screenshots and graphics Certificate of conformity ECLECTICA User Manual ECLP4050018V520 The ECLECTICA system is conforming with the requirements of Directive IVDD 98 79 EC regarding in vitro diagnostics equipment and the applicable harmonized standards included therein Revision A 0 1 4 SECTION 0 Introduction List of Trademarks and Patents ECLECTICA is a trademark of Adaltis Srl The ECLECTICA system is covered by the following patent e Solid phase container Grant Nr 57366 Information about the manual Manufacturer Document This Manual contains the full information required to maintain the functionality of the ECLECTICA instrument and to ensure correct use of its software The Manual is provided together with the instrument and forms an integral part of the system It must be used as a reference inasmuch as it provides the general description of the system and detailed operational maintenance and troubleshooting procedures Before using the instrument read the manual and familiarize yourself thoroughly with it The details and user instructions for the individual a
141. seeeeeeeeess 28 Package 02 Loading Common Reagents Kit Substrate Stop Solution Separation Agent eeseessssssssssssseeerreesssssss 31 Loading the VY ASS OVI OM ccna seceneases snosaaresanvanceameceanoie canna giniest nvsshomnesaabemenuasuadanscutnsannanndasdoautansnbanaaqueceatnasnecamanseeneeuaasanasdoness 33 Package 03 Diluents Kil vies aaneautrenenionceecuaamesleasnitnaegnaeaan EEE SEENA EEEE EAT ARENES EEEN E EES ET ESRAR NENE F SEEEN 34 Package 04 Calibration Kit enatier anion ve cteaanieoesusaneanacnsnobonnasiaecanteraens uns snnanaieioenieaszaquansa saanianne sbacnumel delvanine aueucatlnasnecensgneeenuanmantscanent 36 Package 06 Specific Reagents for Clinical Chemistry tests ccccccccccsssssssssseeeececeeeceeeeeeeeaessssesssseeeeeeeeseeeesaaassegsseeseeeeeeess 39 Package 07 Parametric Multicalibrator sisxtanesncconcccasiecatequowued ousnisensignnesadsionnivasnaguaasad seaninannaciamacenionsbequaddnveawsasnecenegneedeawanseaansaanees 40 PAGS Di MGM S eisino nea REO E AEE E E EE EA E EE A EEE SIETE 43 Loading Common Reagents Wash Solutions cccccccccecececceceeeeaaaeeessseeeeeeeeeeeeeeeeeaaeeeeeesseeeeeeeeeeeeeeeeeeeeeaaaaaeasanseseeeeeess 44 Preparing Storing Using Consumables esesssssssssssssssseeeeereessssssssssssseeeerereosssssssssssseetrrrerereressssssssseterreresssssssssseseeerreeeeesssst 44 Programming a Worklist 45 DNS VY OU IGE E E T EE E E E T E E cwatnvaanedeniver ose EEE E EE 46 Openin asare d
142. sition of the potential danger This label is located on the instrument s cover swing door and sliding window It informs the user of the potential risk associated with opening the cover thus rendering the instrument s work area accessible Revision A 2 3 9 Section 2 Labelling Label 2 Electrical Hazard This label is on the back of the instrument It informs the user of the electrical hazard It tells the user to disconnect the power supply before opening the instrument Label 3 Moving Parts Hazard This label is applied to the work surface next to the Samples carousel and the reaction Cell Washing System It informs the user of the risk associated with certain moving parts e Sampling Needles e Samples Carousel ATTENZIONE WARNING Parti in movimento Moving parts ECLECTICA User Manual Revision A 2 4 9 ECLP4050018V520 Section 2 Labellin Label 4 Bio hazard This label is applied to the working surface and to the hatch in which the waste tank is located It informs the user of the possible risk of biological contamination in the area in question work area waste tank housing Label 5 Waste Tank Bio Hazard This label is located on the waste tank door It informs the user of the possible risk of biological contamination related to the waste tank ECLECTICA User Manual Revision A 2 5 9 ECLP4050018V520 Section 2 Labelling Label 6 Infection hazard This label is located ne
143. ssayed with the same technique to determine the relation between a given concentration and the resulting colour This relation is called the standard curve Sample standard curves for the IEMA and EIA methods are given in the figures Fig 4 10 Sample IEMA standard curve and Fig 4 11 Sample EIA standard curve The procedures for obtaining the standardization are given in Section 7 Operation 00 Aysuag jeaydo nog 00g 5Parameters IU ml Fig 4 10 Sample IEMA standard curve Revision A 4 7 17 Section 4 Operating Principles ECLECTICA User Manual ECLP4050018V520 do Aysuag eado SParameters ug ml Fig 4 11 Sample EIA standard curve The curve generated by the ECLECTICA instrument during standardisation is defined by a mathematical relationship This can be either 5 parametric or 4 parametric Fig 4 12 5 Parameter equation and Fig 4 13 4 Parameter equation These equations relate the concentration of the analyte x with the colour or absorbance on completion of the reaction y The 5 parameter equation contains 5 factors which are constant for each lot of reagent nc ee b ln x c l es p Fig 4 12 5 Parameter equation Parameter a The upper asymptote is the maximum colour density In an IEMA method this corresponds to a high concentration of analyte in an EIA method to a low concentration lack of com
144. ssays are given in the user instructions provided in the ECLECTICA Kit Assay Manual code ECLP4050000018 Adaltis Srl Via Durint 27 20122 Milano Italy Tel 39 0774 5791 Fax 39 0774 353085 www adaltis net Manual code ECLP4050018V520 Revision A Date 15 04 2011 Software release OpenLAB 5 2 0 Date of release 15 04 2011 Purpose of the Document ECLECTICA User Manual ECLP4050018V520 This document is the User Manual for the ECLECTICA system It is addressed to technical laboratory personnel who have experience and practice in using automatic laboratory instrumentation Please read this Manual throughout Please keep this manual close to the ECLECTICA instrument during daily laboratory activity Revision A 0 2 4 SECTION 0 Symbolism Introduction Wherever specific attention is required in reading this Manual the following symbols are used The symbol NOTE in boldface is used to highlight information The symbol WARNING in boldface is used to highlight risks and hazards NOTE The manufacturer Adaltis Srl declares that the information contained in this manual only permits the instrument to which it refers to be used correctly if the user has taken a specific training course as indicated by the manufacturer How to use the Manual Section 1 Safety Section 2 Labelling Section 3 Installation This Manual contains full instructions for using and maintaining the ECLECTICA
145. sscacdaauipaeauspaeaadsetmaneereetaiuas 3 Minimum volume of the samples standards cccccccceeccccecceeeeeeeeeeaeaeeesesseseeeeeeeeeeeeeeeeaaaseeeeeseeeeeeeeeeeeeeeeeeeseesaaaaaseeseeeeeess 3 MS BURA TS ea E ee E E EE ade naed ctnanentcaieatotenend E E E 3 Consumable Materials 5 Preparing the Consumable Materials cccccccccccccssssssseeeseeeeeeeeeeeeeeeeeaaaeeeeeeeeeeeeeeeeeeeeeeeeeaaeeseeessseeeeeeeeeeeeeeeeeaaasaeasanseeseeeeeess 6 Storing the Consumable Materials cccccssssssssseeeececeeeeeeeeeaaeeseseeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeeeeeeeeeeeeeeeeaaeaaesessaeeeeeeeeeeeeeeeeaaaaaegessees 6 Hoone A ee E saws tawu poten asnasanepiotae Snrndavbearaeiendnesnnemansdnevieenntnae 6 PRIMARY FUNCTIONS OF THE OP ENLAB piece ceseseceswcusccesvcuseceseiwentenesccbsseusevesseesssvsssucerssseswses 7 Powering on the instrument 8 OpenLAB Start Up 9 Main TY ih 00 WS Co A east terete eters aceon dsacticawa GpctonSsaa tote dean Oca EE E 1 easy User Intertace Tay GUL personal Zano resien et oa sin tee E EE AEREE EAEE EEE E ventas 14 Loading Consumables Reagents Inventory Management RIM 22 Pepo a E E E E des veatcaaneewtagend 23 CU E S eyo caeiyactn atti esses tarts saree wait pease aang ek be wissen aes voce teuepnemaceaueveeawesutaduattent suas euacanee seaweeds 27 Uploading Data from Smart Card 28 Package 01 Specific Reagents Kit Upload ccssssssssssseeeececeeeeeeenaaaeesesssseeeeeeeeeeeeeeeeeesesaasseaeeaeeeeeeesesesesesaaaeass
146. sts and lists in execution for completed protocols Easy User Interface 5 2 0 gt Eclectica Data Reduction i Information lv Select Session Ok Report to Unit Measure ina Readings ra Finish Documents Recent available sessions Archived sessions Backup y List of recent available sessions rea List of archived sessions ent available session Last Modified ieee HCG 00093 01 03 2011 16 04 01 03 2011 16 04 HCG CTRL Eclectica 00094 01 03 2011 16 52 01 03 2011 16 59 TSH_1 1 HOG_1 1 Eclectica 00091 01 03 2011 16 35 01 03 2011 16 35 HCG_1 500 TSH CTRL TSH_1 1 H Menu Pages Next Close Fig 7 86 e Select Recent Available sessions option Fig 7 86 and select a previously programmed workilist e Press Next to process the results in the nformation you can find a brief description of the worklist Fig 7 46 NOTE the lists in the archive Archived sessions are executed and already reported lists Unit of Measurement In the Unit Measure section Fig 7 88 the user can change the normal values of a test and set the unit of measurement that will be used to present the results of the tests performed Selecting the Unit of measurement example e select the m lU mlI button to open a menu showing the selectable units e select the unit of measurement required for each method in the Used UM column ECLECTICA User Manual Revision A 7
147. system The reaction cuvette wash system is composed of e A manifold Fig 5 8 comprising 12 needles 4 dispensing needles and 8 aspiration needles Fig 5 8 The system runs the wash cycle after magnetic separation by injecting the Wash Solution into the reaction cuvettes via the 4 dispensing needles The reaction mixture is then drawn up from the four cuvettes Then the Wash Solution is once again dispensed into every Cell and the magnetic particles are returned to suspension by means of rapid agitation At this point the instrument performs a new magnetic separation and Wash Solution dispensing cycle The reaction mixture is then drawn up anew ECLECTICA User Manual Revision A 5 11 14 ECLP4050018V520 Section 5 Functions Common Reagents sampling system ECLECTICA User Manual ECLP4050018V520 The immunochemistry Common Reagents sampling system Substrate and Stop is composed of two needles one for each reagent located to the left of the Wash System manifold Fig 5 9 in the reaction Cells and two pumps one for each reagent Fig 5 9 At the end of the wash the Common Reagents Substrate and Stop are dispensed for enzymatic colorimetry development The pumps draw the Common Reagents and dispense them into the reaction cuvettes with the sampling needles Revision A 5 12 14 Section 5 Functions Reading system The reading system is composed of e Needles for drawing up the solutions into the f
148. t Performs a search for calibration kits excluding multi calibrators per type of test Select Common Reagents Kit performs a search for IA common reagents kit Select Diluents Kit Performs a search for diluents for Immunoassay tests IA Multcalibrators Performs a search for multiparametric calibration kits for CC Specific Reagent Kit Performs a search for a specific reagent kit among those uploaded All Calibrators Kit Shows all calibration kits uploaded The shortcut button is Calibrators All Common Reagents Kit Shows all common reagents kits for Immunoassay tests IA uploaded The shortcut button is Common Reagents All Diluents Kits Shows all diluents kits for Immunoassay tests uploaded The shortcut button is Diluents All Specific Reagents Kits Shows specific reagent kits uploaded The shortcut button is Specific Reagents SEARCHING FOR A PACKAGE To search for specific package in the warehouse in the drop down Query box Fig 7 21 select the query AllAvailable TestForPackage Component type Calibrator Se Check expired lot Fig 7 22 When the dialogue box Fig 7 22 Component type opens select one of the specified packages e g Calibrator Set Revision A 1 24 97 Section 7 Operation Press OK A report is displayed Fig 7 23 with all the consumables found in the Eclectica warehouse for the selected package Easy User Interface 5 2 0 z Report 4 Curves Oy le TestForPa Ite
149. t operation of the instrument Section 9 Troubleshooting The user will refer to this Section in order to determine what action to take in response to the error messages displayed on the instrument s screen Section 10 Technical specifications This Section contains the technical specifications including dimensions technical characteristics and electrical and environmental requirements Section 11 Supplementary information This Section contains information regarding warranty restrictions lists of spare parts accessories consumables and ordering information ECLECTICA User Manual Revision A 0 4 4 ECLP4050018V520 Section 1 Safety Instructions SECTION 1 SAFETY INSTRUCTIONS ECLECTICA User Manual ECLP4050018V520 The manufacturer Adaltis Srl reminds you that failure to observe the prescriptions provided in this Section may damage the instrument and the environment injure the user and produce incorrect results This Section describes the following subjects e Operational precautions e Types of risks and consequent instructions e Procedure for stopping the system Detailed information on these subjects is given in the individual Sections into which the Manual is divided The user must strictly observe all information contained in this manual The user must not make any type of modification to the instrument or tamper with the software without the prior authorisation of the manufacturer Adaltis Srl Adaltis Srl is not liable
150. t container The incubation system is made up of an independent rotor coaxial to the samples carousel containing the housings for four Reaction Segments Cells each consisting of 24 cuvettes Fig 5 4 The rotor thus has 96 positions and allows for replacing and loading the 4 Reaction Segments on request The 96 Cells are disposable the software ensures that the reaction Cells are used once only The instrument uses the first four cuvettes of the first segment to wash the reading Cells during the after each spectro photometric reading The incubation temperature is monitored and kept to a range of 37 1 C Revision A 5 5 14 Section 5 Functions Fig 5 4 ECLECTICA User Manual Revision A 5 6 14 ECLP4050018V520 Section 5 Functions Barcode reader identification system The identification system is composed of a barcode reader mounted to the sampler arm which positions it to read the label barcodes The barcode reader Fig 5 5 serves to positively identify bottles of Specific Reagents Controls Calibrators and samples primary test tubes with barcodes The reader is able to read various types of barcodes see Section 10 Technical Specifications Barcode reader Fig 5 5 Sampling System The system for sampling Samples Specific Reagents Controls Calibrators Diluents and Separation Solutions is composed of e 2 Sampling Needles e Syringe e Peristaltic pump e Needle wash station ECLECTICA
151. t wash see Wash with Cleaning kit install the new bottles of Substrate and Stop and the container of Separation Agent To install Common Reagents see Section 3 Installation Connecting the Waste Tank Accessory Vials Section 7 Loading Common Reagents operating procedure Revision A 8 20 32 Section 8 ECLECTICA User Manual ECLP4050018V520 Maintenance Select the lot from the Available lots menu Fig 8 6 WARNING A message confirms the presence in the warehouse of at least one kit of common reagents of the selected lot WARNING A message prompts the user to perform a wash with cleaning kit before changing the common reagent vials From the Special page Fig 8 6 Press Load common reagent This opens a confirm dialogue box All tests that can still be executed will be lost Continue Fig 8 13 m SSS vV psemma H Eclectica Maintenance 1 y The remaining tests of the Common Reagents u curently on board will be lost continue Rep Yez No Fig 8 13 Click on Yes the number of tests 200 of the new package of Common Reagents will be made available The analyzer will automatically charge the Substrate and Stop Solution lines On completion of the charging procedure a message will be displayed confirming that the Common Reagent vials have been loaded NOTE After replacing the Common Reagents before starting a new session run the weekly Start Up proc
152. termination save the list with the un executed test and run it later On termination save the list with the un executed test and run it later On termination save the list with the un executed test and run it later On termination save the list with the un executed test and run it later On termination save the list with the un executed test and run it later 9 6 9 Section 9 Troubleshootin The following errors may arise while running the calibration procedure The message for each error is given both in the Start page and in the execution report in correspondence with the test executed The error message is shown in parentheses and will be printed out on the internal printer Error message Internal Probable cause Possible solution orinter Values threshold error Acc 1 During execution of a 1 Run only the Controls again to Error worklist with samples obtain the results of the samples and Controls the selecting the worklist containing the The message appears in the values of the controls to be executed from Remark field of the Execution Controls obtained among the pending lists Report are outside the accepted range Remark 2 Nee Erri 2 During execution ofa k worklist with only Controls the values of the Controls obtained are outside the accepted range Curve not accepted Crv 1 During a worklist Run only the Controls again to Rejected including samples obtain the results of the sampl
153. th cotton wool soaked in Solution A Remove the deposits Dampen all other surfaces with the same Solution A film of moisture should remain on the surfaces for at least 15 minutes in order to achieve an acceptable level of disinfection Remove the hypochlorite with cotton wool soaked in deionised water Clean all metal needles carefully reagent sample dispensing needles and wash solution dispensing needles with cotton wool soaked in Solution A Remove the hypochlorite with cotton wool soaked in deionised water Completely empty the Waste Discharge Tank Fill the tank with Solution B and leave for approximately one hour Thoroughly rinse with deionised water NOTE The treatment described above does not ensure that the instrument becomes sterile i e that all of the viruses and microorganisms are completely inactive but it minimises the risk of contamination Revision A 8 31 32 Section 8 Maintenance The table shows the maintenance procedures and frequencies Procedure Details Every Every week Whenever day necessary Daily Start Up Charge Common Reagent vA lines run autozero Weekly Start Up Charge Common Reagent Y Sed a ia i ae package o working week or if the Reagents is instrument has not been installed used for more than 24 hours Shut Down Wash sampling needles vA reaction Cell washing needles reading system needles flow Cells Wash with Wash Common Reagent lines Y S Cleaning Kit with Rinse Solution and
154. the corresponding results and normal values for each patient Easy User Interface 5 2 0 gt Eclectica Data Reduction Eclectica anagl gt Oo Information i Unit Measure x Select Session m Readings m Report iv Finish w Back Next 2 Home Print Preview es Print A Report Patient 20115001035026 Sample SMF 1 Session Eclectica 00091 Name John Run Date 01 03 2011 Last Name Smith Print Date 02 03 2011 Birth Date 05 03 1968 User Sex Male instrument sn Eclectica Pregnant 2nd Trimester 5280 66600 mlU ml Pregnant 3rd Trimester 4280 37400 mlU ml Male lt 1 mlU ml Female lt 45 years old lt 1 mlU ml Healthy 0 6 4 8 ulU mi TSH 1 1 1 0 05 ulU ml Male lt 1 mlU ml Female lt 45 years old lt 1 mlU ml Female gt 45 years old lt 5 mlU ml HCG 1 1 500 2500 00 mlU ml Female gt 45 years old lt 5 mlU ml Pregnant 4 8 weeks 104 149000 miU ml mlU ml Pregnant 9 12 weeks 37700 225000 mlU ml Pregnant we OPA 5280 66600 mlU ml Pregnant 4 8 weeks 104 149000 mlU ml Annn AMFA Hist Pregnant 9 12 weeks 37700 225000 mlU ml Menu Pages Back Next Finish Clase Fig 7 95 Shut Down Procedure When the Work List s have been executed perform the Shut Down procedure as described in Shut Down in Section 8 Maintenance WARNING If the Shut Down procedure is performed incorrectly this might compromise proper operation of the instrument ECLECTICA
155. the bar to the required position cx 5 2 0 gt Home Page orklist Management Z l clectica Work List ent A Home Create or Modify Work Lists for Eclectica v Back Worklist Execution Next X AJ Eclectica Work Li ecution Execute Work Lists on Eclectica Data Reduction amp Reporting w Help Eclectica Data Reduction Wie Perform data reduction for Eclectica sessions Instrument Maintenance Eclectica Maintenance Maintenance operation for Eclectica instrument Management amp Tools R Inventory Management Reagent Inventory Management for OpenLAB suite Ki of O Fig 7 11 Several bar position examples are shown below Bar at the top Easy User Interface 5 2 0 gt Home Page Ps Home v Back X Next v Options v Help X D Exit j Worklist Management l ar A Eclectica Work List Man nt Create or Modify Work Lists for Eclectica Fig 7 12 ECLECTICA User Manual Revision A 7 18 97 ECLP4050018V520 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 Bar at the bottom Management amp Tools Inventory Man ent Reagent Inventory Management for OpenLAB suite Y a gt ea Home ay Bo v Next Options Y wy Help 7 Exit l Fig 7 13 Bar on the right ee Home EE oe Next x Options Ge O Fig 7 14 Revision A 7 19 97 Section 7 Operation How to hide the modules tab page To disable module p
156. the cleaning solution in the diluent 1 and CC diluent positions Fig 8 10 ECLECTICA User Manual Revision A 8 16 32 ECLP4050018V520 Section 8 Maintenance Cleaning solution Diluent 1 position Cleaning solution CC Diluent Position NOTE Close the Common Reagents vials after disconnecting them from the analyzer and store as indicated on their label Press OK to start the Cleaning Kit wash procedure On completion the following message appears Eclectica Maintenance 0 Remove the Rinse solution vials and load a distilled water Bottles Remove the cleaning we sdlution and load two bottles of distilled water in position Diluent 1 and diluent CE Replace the vials and press OK ECLECTICA User Manual Revision A 8 1 7 32 ECLP4050018V520 Section 8 Maintenance Sampling Needles Wash WARNING You should perform this wash procedure if the analyzer returns imprecise results From the Special page Fig 8 6 Special press Wash Sampling Needles This opens a confirm dialogue box Fig 8 11 2 Eclectica Maintenance 1 P Load the two bottles containing Cleaning r Solution in Diluent 1 position and diluent CC position Fig 8 11 Load the two vials containing the cleaning solution in the diluent 1 and CC diluent positions Click on OK to start the wash with cleaning solution On completion the following message appears Remove the Cleaning Solution vials a
157. the message Insert Smart Card Insert the Smart Card in the reader Insert the Smart Card with the writing facing upwards and the chip facing the instrument Wait for the red light on the reader to go out When the data have been uploaded the message Remove Smart Card will be displayed After the data have been uploaded from the Smart Card the following information will appear on the Smart Card Viewer page Fig 7 29 for each method Eclectica SmartCard Viewer Package Package Code or Analyte Analyte Code TSH General Lot 0037A Serial number P0002 Expiry date 312077201 Barcode Key 366E Available Tests fico Reagent Codes Rea 1 jas Rea 2 foo Control Codes cm 1 50 Ctrl 2 51 Master Curve Cal A Cal B Cal C Cal D Cal E Cal F Cal G Ctrl 1 Ctrl 2 Concentration Ee 036000 fi 060 pao fiso 46200 D Concentration 0 530 7 200 289 564 580 Mm ol w S ol oo o j i i oO al al a S e g ea Si e Method Code e Lot Code e Expiry date e Tests Available Fig 7 29 e Smart Card serial number and barcode e Master Curve Optical concentration and density values of the calibration curve e Controls Optical concentration and density values Press OK Fig 7 29 and remove the Smart Card Once the Smart Card has been used it cannot be used again ECLECTICA User Manual Revision A ECLP4050018V520 7 29 97
158. ton Fig 7 77 Also the available tests for the selected vial will be highlighted M Resources Management x Scan Samples moving to 25 Left Right Q Available units TSH 00374 10 TSH 00374 10 Fig 7 76 Revision A 7 70 97 Section 7 Operation The following table provides an overview of all the commands selectable from the menu Command Load Load gt All vials Load gt Analyte gt All vials Load gt Analyte gt Vial code Replace Remove RemoveAll Move Discard ECLECTICA User Manual Revision A ECLP4050018V520 Description Loading Reagents Controls Calibrators on reagents samples carousel Select the required position on the plate with the left Load button The following menus assist the User in choosing the most appropriate components Loading all reagents controls in sequence on the samples carousel starting from the selected position Serves to load all vials associated with a specific test Serves to load only one type of vial in the case of reagent kits Replace the contents of a given position with a different component Remove the previously allocated reagent or control Remove all previously allocated reagents or controls Move the vial from one position to another Discard a vial and its contents The number of tests available for the discarded resource is consequently decreased 7 11 97 Section 7 Operation Loading Samples The SamplePlate p
159. trument In any case the two cooling fans located on the lower part of the rear housing must have a free space around them of at least 10 cm relative to a wall of at least 30 cm dividing the instrument from other laboratory equipment for details see Fig 3 1 ECLECTICA User Manual Revision A 3 1 10 ECLP4050018V520 Section 3 Installation Environmental Constraints Transport The room where the instrument is installed should be equipped with an air conditioning system so as to have a constant temperature from 15 to 35 C and a correct degree of humidity from 20 to 80 of relative non condensing humidity Avoid direct exposure to sunlight The instrument must be installed far away from heat sources The ECLECTICA instrument and its included materials are shipped in the original packing consisting of a wooden crate This packing can be reused if the instrument has to be moved or sent back Checking for Damage Due to Transport ECLECTICA User Manual ECLP4050018V520 Check that the packing is not damaged upon receipt of the instrument Any damages caused by transport must be immediately notified to the forwarding company that transported the goods and be promptly recorded Once the forwarding company has delivered the goods responsibility for its integrity lies with the receiver Check that the packaging is not damaged A SHOCKWATCH label is applied to the packaging the bulb turns red if the package
160. ts power supply while it is operating Check the position of the vials of reagent and the sample tubes inside the instrument ns WARNING Incorrect positioning could generate errors in calculating the dispensing volumes Do not allow foam to form either when homogenizing the solutions or when loading the reagents and sample tubes into the instrument on WARNING Bubbles and foam can affect the operation of the level sensor and cause incorrect volume dispensing or dispensing failure thus resulting in errors Prevent liquids from leaking inside the instrument s work area Do not replace or reposition reagents and samples after their barcodes have been read active recognition Make sure that all caps on the reagents have been removed so as to prevent collisions with the sampling needles Check that a sufficient number of reaction cells have been loaded onto the instrument Respond to the system s messages concerning the level of liquid wastes liquid waste tank and solid waste Reaction Segments during use Revision A 1 4 14 Section 1 Safety Instructions Using Consumables Reagents For correct use of ECLECTICA consumables e Do not use other consumables than those specified by Adaltis Srl e Use all the consumables Reagents within their period of validity see label on WARNING Use of a reagent after its expiry date may give incorrect results e Use the consumables in their original pac
161. tware messages You should therefore read this heading carefully Revision A 7 1 97 Section 7 Operation Powering on the instrument There are two switches on the rear of the instrument on the right Fig 7 1 e the lower switch powers the instrument on the upper switch activates the Reagents carousel refrigeration system Turn on both switches and wait for the software initialisation procedure to complete Refrigeration switch Fig 7 1 ECLECTICA User Manual Revision A 7 8 97 ECLP4050018V520 Section 7 Operation OpenLAB Start Up Open the ECLECTICA OpenLAB management software by double clicking on the Eclectica OpenLAB icon on the desktop lll OpenlAg Startup or by clicking on Start in the Windows taskbar and selecting All Programs gt Adaltis gt OpenLAB Start up The main menu of the ECLECTICA management software will appear Fig 7 2 Easy User Interface You can navigate around the various program modules without the modules being closed each time you switch from to another Easy User Interface 5 2 0 gt Home Page Worklist Management l Eclectica Work List Management Create or Modify Work Lists for Eclectica Worklist Execution AL Eclectica Work List Execution eC t Execute Work Lists on Eclectica Data Reduction amp Reporting Eclectica Data Reduction Perform data reduction for Eclectica sessions Instrument Maintenance Management amp
162. ty Control to associate the quality control with the selected sample Revision A 7 55 97 Section 7 Operation Face 5 2 0 gt Eclectica Work List Manag asy Liser I F fa 7 F al F Hew Workct i Information ff Frogramming Code a From Ta e voc Ln Tt T T r w Fig 7 57 Automatic samples identification Press Barcode Fig 7 58 Barcode Fig 7 58 for automatic identification of the sample tubes barcodes Fig 7 59 Scan Samples moving to G ist Right W Qx Fig 7 59 ECLECTICA User Manual Revision A 7 56 97 ECLP4050018V520 Section 7 Operation i FA i Open AB suite 1 i P j The barcode reader is starting on Are you sure Yes Mo Fig 7 60 Select any position on the samples plate with the left mouse button and select Scan A message will be displayed Fig 7 61 When the sample tubes barcode identification procedure is concluded the positions of the samples will be automatically associated on the samples plate Managing lists from LIS Select L S Fig 7 61 to acquire a worklist from the Host or to retrieve previously executed programming GESS Fig 7 61 Select the worklist and click on OK Fig 7 62 Available Work Lists Recived from To Eclectica 00091 01 03 2011 15 54 16 Eclectica Work List Manag Reread last progra Fig 7 62 ECLECTICA User Manual Rev
163. ufacturer to the Client hereinafter the Warranty Period During the Warranty Period Adaltis Srl will repair or replace at its own discretion any detective product on condition that the Client promptly communicates the defect to Adaltis Srl In the case Products delivered to distributors the Warranty period is extended by two months This warranty applies exclusively to new products which have never been used and which have not after shipment by Adaltis Srl been damaged altered repaired or modified in any manner due to negligence or other reasons by persons not authorised to represent Adaltis even if they have sold worked on the product Adaltis Srl is not liable for any Warranty obligations should any modifications or repairs have been made to the product without Adaltis Srl s express written consent This Warranty applies to products which replace detective products and to repaired products for the duration of the original Warranty Period only Unless agreed in writing by Adaltis Srl the Warranty period cannot be extended as a result of defects or repairs Transfer of the ownership of the product by the Client to a third party does not extend the warranty period which remains bound by the above conditions The above warranty is exclusive and replaces any other guarantees Adaltis Srl does not provide any other guarantees explicit or implicit regarding the product except for the present Warranty Without limitation to the
164. urces mormon yeaa Available tests 96 HCG HCG ma gt Cury iv Finish FS s D Open Worklist l Curves Run Calibration Expiry Date 15 03 2011 Use this Lot M Controls Calibration Lot O0S7A EPY A vaitable tests 100 1 Calibration Expiry Date Use this Lot M Controls M Calibration Menu Pages lt Back Next gt Fig 7 70 The figure shows an example relative to two programmed tests the lots of which are valid but it is necessary to execute controls C1 and C2 for the HCG test immunoassay and standardization Curve for the clinical chemistry test glucose All the lots loaded for each analyte and their status are also displayed The various options are summarised below In this case it is necessary to execute controls of a curve Calibrators option selected or standardization Curves option selected If several lots have been loaded on the analyzer you can select which lot you wish to use in the current worklist selecting the Use this Lot option in correspondence with the chosen lot Revision A 7 65 97 Section 7 Operation Lot 00038 Expiry HCG HCG Date 31 12 2011 Available tests 96 Calibration Expiry Date 15 03 2011 Use this Lot V Controls Calibration l In this case the lot is valid and that calibration does not call for any further action none of the Calibrators or Curve options are checked j l e I CEA CEA In this
165. ve already been created and or perform calibration standardization operations Data Reduction and Reporting Used to display and print out the results of the worklists executed Reagents management RIM Reagents Warehouse Provides the facility to manage warehouses and contents loading and unloading the materials required for the correct execution of each work session Instrument Maintenance Used to carry out all maintenance activities cleaning the instrument replacing Common Reagents changing Reaction Segments emptying the Waste Tank performing the autozero procedure that may be required See Section 8 Maintenance for details The additional functions which are identified by specific icons on the side bar of the Main Menu accessible by clicking on the Menu button at the bottom left are ECLECTICA User Manual Revision A ECLP4050018V520 7 12 97 Section 7 Operation ECLECTICA User Manual ECLP4050018V520 Pes Home Page Import panels m Options wW About D Exit Revision A Home Page The Home Page button opens the main window of the Easy User Interface fig 7 1 It is used to go in the main page form another plugin Back Next These buttons are used to navigate through the open plugins Import Panels The Import Panels button serves to import validated panels Options The Options button serves to set configurable software parameters paths rep
166. xt to Label 3 Moving parts hazard It informs the user of the possible risk of biological contamination associated with contact with this part of the instrument Label 7 Laser Light Hazard This label is on the bar code reader It informs the user about the hazard associated with the laser beam and the characteristics of the laser source Avoid exposure laser light is emitted from this aperture Evitare l esposizione luce laser emessa da questa apertura ECLECTICA User Manual Revision A 2 6 9 ECLP4050018V520 Section 2 Labelling Layout of labels on the instrument We show below the locations of the above labels on the instrument Front view ECLECTICA User Manual Revision A 2 7 9 ECLP4050018V520 Section 2 Labelling Rear view ECLECTICA User Manual Revision A 2 8 9 ECLP4050018V520 Section 2 Labelling Side view ECLECTICA User Manual Revision A 2 9 9 ECLP4050018V520 Section 3 Installation SECTION 3 INSTALLATION Preparation before Installation Before removing the packaging check that all mechanical and environmental requirements are observed Mechanical Constraints The ECLECTICA instrument requires a table at least 1 5 metres long and at least 80 cm deep The table must be stable so as to prevent undesirable oscillations or vibrations when using the instrument Provide e Atleast 1 metre headroom above the work surface e Workspace of at least 50 cm around the ins
167. y EIA Phases 1 and 2 Phase 1 Immu nological Teac Om s ssvenscicomcetecsontesatsewnsiucdansiacesaatdaantincedscunptadaeutevetucnanteticnsboutscwansnds Phase 2 Magnetic separati Oi scr asaceoneanateanasuadanncuamadiacnonGnsacawes satniandnsaoneinbtmeecnGnisieennetatarsacnennbieciads Washes and separat OM aceiren aar E E RET IEE A E Phase i Enzymatic BAG NOM cra spac onenac caine a EE E E VOUT ES VC VO MG eea E E E E ET Colour mea URC NC AU eena a E E E S E enema EEN Spectrophotometric Reading System ossooooeeeeeesssssssssssseeettrrrrssssssssssssseetereresssssssssssseeeeeeeeeeee Data processing and results AOL 10 0 2114 A AE a O E E Re E E E EE E AE AEAT EAEE E AAT Immunology calibration method PRINCIPLE OF CLINICAL CHEMISTRY ASSAYS cccssseeseeeeeeeeseeees Clinical Chemistry Determinations Types of reaction End Point reactions 4 schacanssevescuesvacsese aioe dinonesaneasexevesevadvaanene Wee ivmpeaavans seve stabunsatuenseenseasdenadoeansdenvebeos Kinetic reactions c ccccececcececcecsccecsccecscescscscecsscaccecsccecscescscestecscescsetecsececscescscestscesescssescsceecs Fixed IME arruan eeren ANENE EEEE EEE AEE EE E E a SEGUON Do savesonceancascsseecesepececssneeessuseeeurdewsesasee FUNG THONS erence teense ne ge EEOAE EE EEEE E EEEE E Purpose Description of functions Description of subsystems Work Area IR 6G D a E E E Sapes E roS ee E E EEE Incubation SySteti sesde iD E OAE
168. ys with the ECLECTICA system The ECLETICA system instrument and consumables is intended exclusively for in vitro diagnostic use The ECLECTICA system instrument and consumable materials is designed for professional applications It must therefore be used only by expert laboratory personnel The user must strictly observe all information contained in this Section Restrictions on immunoenzymatic assays Do not use either EDTA or sodium citrate as an anticoagulant because they prohibit enzymatic reaction Cloudiness aggregates or precipitates that may be present in the reagents may be a sign that they have possibly deteriorated in this case notify the local dealer reporting the problems noticed As is true for all immunoenzymatic assays results may be influenced by factors present in the patient s serum Although formulation of the reagents was studied in order to minimize interference due to the presence of both heterophile antibodies and a specific bonds possible invalidation of a single sample cannot be ruled out as is true for all Sandwich systems For diagnostic purposes the results obtained from this assay must always be used together with the clinical examination the patients anamnesis and other laboratory investigations Scrupulously follow the User Instructions because any modification can bring about a change in the results The use of reagents consumable material or spare parts not supplied by the author

ECLP4050018V520-Eclectica User Manual V5.2.0

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