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1. OOOOOOOOOOOCOCOOCOOOQOOM 66 686606 4 2 NJ Figure 2 2 QUATTRO View on top level 1a Dilution plates see chapter 2 2 1 on page 2 3 selftest 1b Tip racks see chapter 2 2 1 on page 2 3 2 Patient sample and reagent unit see chapter 2 2 2 on page 2 4 Tip ejection station and waste bag see chapter 2 2 3 on page 2 4 3b Pipettor wash station see chapter 2 2 3 on page 2 4 3c station see chapter 2 2 3 on page 2 4 4 Test plate compartment with plate transport unit see chapter 2 2 4 on page 2 5 2 2 ELISYS QUATTRO User Manual HUMAN System Basics 2 2 1 Tray for Tip Racks and Pre dilution The tray is accessible via a drawer which is locked automatically as soon as a run has been started The tray includes 5 positions for tip racks 300 ul or 1100 ul tips see figure 2 2 position 1b as well as a position for the dilution rack see figure 2 2 position 1a 6 additional reagent positions are also available Move the tip rack from above straight into the specific position the groove must fit into the pin see figure 2 3 and see chapter 5 1 on page 5 1 The clamp shall fix the tip rack Pin Groove A Figure 2 3 Placement of tip racks A1 is on the top left ELISYS QUATTRO User Manual HUMAN 2 3 System Basics 2 4 2 2 2 Patient Sample and
2. axi Unallocated resources LLL o HP eo o o o 22 O 2009 a 206 Mo 099 m Pe 3000 Samples Open Reagent Layout Redraw Unallocated Resources Scanner Setup Save Reagent Layout Cancel Help Dragging means clicking with the mouse on a resource keeping the mouse button pressed down moving it to the desired location and releasing the The Auto Arrange function always arranges the samples by using the None sort order as selected in the Patient Editor After its use it is rec ommended to perform a random manual verification of the sample IDs in the rack This type of verification is also recommended when working with a job list manually created for sample tubes without barcodes 4 14 ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 4 3 Loading other Required Resources Load disposable tips and dilution plates as well as wash buffer and distilled water as shown on the x screen The number and size of the required tips is m displayed r 1o 2 Observe defaulted positioning Tip racks depicted in dark grey and light grey must He be loaded in addition 2698 300 ul tips are depicted in dark grey oa 1100 ul tips are depicted in light grey 600 Only complete tip racks sho
3. System Waste liquid Figure 2 6 ELISYS QUATTRO Instrument rear panel with connections ELISYS QUATTRO User Manual HUMAN System Basics 10 Tubing connection for system liquid 11 Electrical connection for system liquid level sensor 12 PC port RS232 9 pole 13 Mains fuses mains switch and mains connection 14 Liquid waste outlet 15 Electrical connection of waste container level sensor 16 Waste from pipettor wash station 17 To protect tubings and cables 18 Ventilation channels Pass tubings and cables through below the bow Don t position the equipment so that it is difficult to operate the discon necting device The ventilation channels must not be blocked Observe minimum dis tance of 15 cm The level sensors inform you about the status of the respective container full empty A corresponding message appears on the screen Before starting a run check both containers gt eE 2 6 LED Displays The LED displays on the instrument front panel next to the left and right door have the following meaning Left PWR Power Green when turned on otherwise off Ready Green when ready for a run otherwise RDY acie off e g in case of Error or during initiali sation Error Yellow when instrument error has ERR d occurred otherwise off ELISYS QUATTRO User Manual HUMAN 2 9 System Basics Drawer Green when left drawer has been cleared DWR E for loading and unload
4. m Sample and reagent racks are depicted iz 333385 ES on HE Non bar coded samples and host connection No racks are depicted yet HHSO 2522180 a a 20 8 C 1 10141 E For Help press F1 NUM 4 4 1 5 Active Event Log The Active event log shows the communica tion protocol listing all steps of the ELISYS QUAT TRO Example E m P DE amp 8 Tel gt a Ld e Important actions in this context are warning and 5 577 25 H H Schedule 09 18 55 03042800 Washing with 5 500ul of Wash Sorin error messages they are displayed in red me anon eU ELEM Reactions by the user on these actions are dis ace String pte Same ispensaor tarting to pipette Y IgM Pos Ctrl Dispense played in green oye 45 03042000 Staring to pipette CYTO AGM Neg Dispense A gt Kai 09 16 45 03042800 Starting to pipette Sample Dilution User actions such as manual definition of rea Duos cipem Sata 09 15 28 System Starting worklist gents are also displayed in red 4 ica Ka E For Help press F1 inom ELISYS QUATTRO User Manual HUMAN 4 11 Performing a Test Run 4 4 1 6 Job List The Job list shows the allocation of patient IDs and tests to be performed in a list EEE EP 4 12 Phoenix Work9 l x f file g
5. If you did not enter any patient codes before creating the worklist this window does not contain any patients In this case you can assign assay patients via the Patient Details button in the Set up Panel dialogue box Patient s dialogue If a sample is already assigned to the worklist it disappears from the Select To run the same patient with the same assay on more then one plate the op tion Allow multiple determinations must be selected ELISYS QUATTRO User Manual HUMAN Performing a Test Run The selected patients are listed in the Set Up Panel dialogue box as contents of the assay set up Pane x folder 1 Plate 1 Add Plate p Plate 1 CYTO gG D UD ESTE ass E j 318262 Add Patient 50 74 318263 51 15 EA 318264 p sz 318265 E 53 54 72 Undo IV Start assay with a new strip Edit Layout 2 m Open Panel Save Panel Patient Details OK Cancel Help 4 3 2 Defining Several Assays per Plate 1 The respective plate must be active If not click on the plate name in the Explorer tree set up pane x 2 Click on the Add Assay TD again to place a 03042600 FRUMENTUM MEME EUR second assay on the same plate tac
6. View Recalculate After having changed the parameters for the assay this function starts the recalculation The data reduction of the raw data will be done using the new parameters Utilities Export Results Shows a dialogue to start the export of the results to a file and or to LIMS Table 3 3 Result menu guidance ELISYS QUATTRO User Manual HUMAN 3 5 Software Structure and Operation 3 3 File Types File Extension Path File polling format setting of the import file for host sys apm C Phoenix tems For detailed information see ELISYS QUATTRO Connectivity Manual Cat No 16300 4 available on request Assay protocol files asy C Phoenix Assays Files documenting daily data communication between PC log C Phoenix Eventlogs and ELISYS QUATTRO instrument as well as error mes sages Coordinate files for e g pre dilution plates mpc C Phoenix Coordinate files for the racks rac C Phoenix Result files res C Phoenix Results Spectrum files contain data of a spectrum acquisition spe C Phoenix selftest files with information about the selftests that were tst C Phoenix performed Export files in ASCII format txt C Phoenix Export ASCII patient data import files can be downloaded from a txt For host connection host computer to the Phoenix software patient with associated assays Verification report files ver C Phoenix Worklist files wor C
7. ELISYS QUATTRO User Manual HUMAN PC requirements PC RAM Ports Hard disk CD ROM drive Accessories Software features Operating system Technical Data IBM compatible Pentium PC At least 64 MB 2 serial ports 1 parallel port Hard disk with min 150 MB free hard disk space Colour monitor Keyboard and mouse Printer Microsoft Windows 95 or Microsoft Windows 2000 Mains voltage and fuses Universal a c input Main fuses Computer monitor and printer Dimensions WxDxH Weight Analyzer with cover Accessories Noise ELISYS QUATTRO User Manual HUMAN 100 260 VAC 47 63 Hz Typically max 500 VA 4AT For electrical details of the PC equipment please refer to the technical documentation of the manu facturer 114 cm x 156 cm x 100 cm Depth with waste bag and completely opened drawer 130 kg Approximate 84 kg For electrical details of the PC equipment please refer to the technical documentation of the OEM manufacturer 67 dB distance 1 m 8 3 Technical Data 8 4 Environment conditions This standard applies for equipment designed to be safe at least under the following conditions Operating conditions indoor use altitude up to 2000 m temperature 5 C to 40 C maximum relative humidity 80 for tempera tures up to 31 C decreasing linearly to 50 relative humidity at 40 C mains supply voltage fluctuations up to 10 of the nominal voltage
8. 5 1 6 Load Test Plates CAUTION Laser radiation do not stare into beam 1 When the software requests a plate the LD LED lights up green on the instrument front panel next to the right flap and the Load Plate dialogue appears 2 Open flap very right The plate transport unit is already in a position directly next to the plate compartment 3 Place test plate in holding frame see chapter 2 2 4 on page 2 5 and push it in overcoming a slight resistance ET Check if the plate has been inserted correctly and make sure no strip extends beyond the edge of the frame 4 Place holding frame onto the plate transport unit such that both pins of the holding frame on the right sit in the openings of the slide on the plate trans port unit see chapter 2 2 4 on page 2 5 5 Close flap 6 In the Load Plate dialogue enter the plate ID and click OK or Scan when using bar coded plates T The test plate is first transported into the photometer to check for an ade quate strip filling then the plate is placed in the pipettor area 8 Repeat this process to load several plates in succession ELISYS QUATTRO User Manual HUMAN 5 5 Loading Unloading Disposal 5 6 5 2 Unloading 5 2 1 Remove Dilution Tubes Take Tip Racks off 1 Pull very left drawer out The LED DWR must light up green Take dilution tube s and or empty tip racks out of holding devices Partially used tip racks must remain in the original position The i
9. RUBE IgG Qual asy RUBE IgG asy RUBE IgG2cal asy RUBE IgM asy TOXO lgG2cal asy TAXN Iahd asn Select All i You will find further information to the tests in the manual of the respective test ELISYS QUATTRO User Manual HUMAN 4 3 Performing a Test Run From the respective list box with all available 4 2 2 Input of Bar Coded Patient Samples Insert samples into the ELISYS QUATTRO with the worklist closed The patient bar codes are read The dialogue box depicted to the right appears on the screen showing the identified bar codes Patient Editor Patient IDs CYTO4g8 v Ru amp E4gG v roxo46 7 Assays Y Y 00000342 Y 0000043 no000344 Y 00000345 1 2 3 4 amp te 8 8 3 Y assays select the respective assay by clicking on the column header Then assign the samples by clicking on the field in the respective assay column Wem c Click on the Close to accept the selection n oon Proceed accordingly for each further sample 12 fooo00g62 707 13 000053 rack deg 15 foooogsss 16 17 ps 18 oppose 19 pons Y SISISIS 00000347 00000348 SISISISISISISISISISISIS 2j He Em The patient editor only accepts letters and numbers as pati
10. 6 3 3 Maintenance of Pipettor System 6 5 6 3 4 Maintenance of Washer System 6 5 6 4 Cleaning the Wash Head 6 6 65 Replacement of Mains 6 7 6 6 6 8 6 7 Putting System Out of Action 6 8 ELISYS QUATTRO User Manual HUMAN 7 Error Messages 7 1 7 1 General Error Messages 7 1 7 2 Error Messages of 7 6 amp Technical Data exer Sesto 8 1 ELISYS QUATTRO User Manual HUMAN TOC 3 TOC 4 ELISYS QUATTRO User Manual HUMAN Intended Use 1 Intended Use The ELISYS QUATTRO system consists of the ELISYS QUATTRO instrument and the Phoenix software It is a fully automated microplate analyzer performing the complete sample processing sample dilutions sample and reagent dispensing in cubations wash processes plate transports as well as the photometric measure ment and evaluation For in Vitro Diagnostics only Prior the use of the ELISYS QUATTRO system for IVDs any test methods assays and kits must be validated by the user in combination with the system according to common clinical laboratory practice local legislation and the state of the art 1 1 Typographical Conventi
11. Phoenix Table 3 4 File types 3 6 ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 Performing a Test Run 4 1 System Start 1 Start the ELISYS QUATTRO instrument 2 Start the computer 3 Start the Phoenix software by clicking on the respective icon on the desktop or choosing Start Phoenix 4 Click on the OK button You don t need User or word To run the Phoenix software in demo mode tick the Demo mode check box The Phoenix software can be run without the ELISYS QUATTRO instrument 5 After that a system selftest is performed and checks all instrument functions The result of this wmm HEA l8l EL View tities Window Help instrument check is then displayed on the screen 5 loz e a ejt 19 04 2004 Time 13 38 14 SSSSSS Display help for clicked on buttons menus and windows NUM ELISYS QUATTRO User Manual HUMAN 4 1 Performing a Test Run 4 2 Input of Patient Data 4 2 1 Manual Input of Patient Data 1 Select Utilities Patient Details or click on the icon on the tool bar and define the patients and the associated tests in the Patient Edi tor 2 Click on the Add Patient s button to open the Add Patient s dialogue box r Sort Order Ascending C Descending C None Add Patient s Add Test s Edit Delete Delete All Undo R 3 Enter the first sample n
12. nels Upper or lower optic block is dirty or faulty The optical blocks have to be cleaned by service personnel Call service Colorimeter plate motor home error The system does not recognise the current position of the plate motor in the measuring area The plate motor has to be moved to the home posi tion Select the menu item Utilities Selftest to initialise the system again Colorimeter plate motor movement error Error of motor when moving the plate to the measurement area Select the menu item Utilities Selftest to initialise the system again If the error persists call service Colorimeter voltage reference error Error in reference voltage of the pho tometer Call service COMGEN error 1 RS232 connection faulty Check correct connection between PC and analyzer Start PC and analyzer again error in 1 Error in component 961 COMGEN target over Call service flow error COP serial port test The components are connected via Call service error serial interfaces to the control board Error in serial interfaces ERROR Argument Component cannot be actuated Call service Error scheduling plate Error in assay or missing resources This error message is displayed in the worklist for the respective plate after the active worklist has been verified The worklist or the assay has to be changed accordingly error Incubator hea
13. racks is not connected Manual allocation of racks or samples and reagents is possible Call service ELISYS QUATTRO User Manual HUMAN 7 3 Error Messages Error Cause Action Reading at 1 2 Message measurement at wave lengths 1 2 Reagent is unde fined The reagent has not been defined Reagent has to be defined in the rea gent database Enter the parameters of the reagent in the reagent database Resuming after a crash PC does not respond while process ing the worklist and has to be restarted Following restart of the PC you may be able to save the worklist and the results Connection to the analyzer is estab lished and the results stored there are transferred to the PC RS232 write error command 1 Error in interface PC analyzer Check connections Shaking at 1 for 2 seconds Message indicating that shaking is performed at a frequency of 961 for the duration of 2 seconds Some required resources have not been allocated to sys tem positions Not all required reagents have been allocated to a position All reagents requested in the Load window have to be allocated to a posi tion or have to be loaded Suspect tip pickup Pipettor cannot take up pipettor tip correctly does not move deep enough into the tip New teaching of pipettor required Call service System cover closed Message instrument cover is
14. samples reagents and tips 400 700 nm 0 100 to 3 000 O D 0 005 or 2 5 96 0 2 000 O D 1 96 Photo diode 15 seconds OD Up to 8 positions 8 1 Technical Data 8 2 Pipetting System Pipettor Liquid level detec tion Min Max volumes Accuracy Precision Features Washing Capacity Wash head Dispense volume Precision Residual volume Fluid alarms Features Others Bar code Plate bar code read er Interfaces Time Scheduling Multiple assays per plate Export options Qualitative Quantitative Language support QA analysis Liquid pipettor for disposable tips Standard capacitive 10 ul to 300 ul with 300 ul tips or 301 ul to 1000 ul with 1100 ul tips lt 15 at 25 ul aqua lt 5 at 100 ul aqua lt 5 CV at 25 ul lt 2 5 CV at 100 ul Tip detection mixing multi dispensing Up to 4 buffers 1x8 200 2500 ul well 5 CV at 300 ul lt 2 5 ul in U shaped bottom 4 ulin flat bottom Low reagent waste full Sweeps soak purge top and bottom wash vari able pump speeds Samples and in rack system Optional ASTM interface Schedules 4 plates Up to 12 assays per plate ASCII export and report User definable result classes Linear to quadratic regression sigmoidal and many more Optional supported via use of Passolo commer cially available program Mean SD CV Standard Error and Levey Jen nings basic version
15. 2 3 Tip Ejection Station Pipettor Wash Station Pipetting Station Tip ejection station and waste bag see figure 2 2 position 3a The opening serves as ejection station for disposable tips The ejected tip is trans ported into the waste bag via a slide which is attached to the front side of the instru ment The ejection station is closed by a cover plate which can be pulled off by hand With the cover plate removed the waste bag can be taken out of the holding device and replaced Disposal see chapter 5 3 on page 5 7 Pipettor wash station see figure 2 2 position 3b The pipettor wash station is located next to the tip ejection station ELISYS QUATTRO User Manual HUMAN System Basics Pipetting station see figure 2 2 position 3c The test plates are positioned by the system Up to 4 plates can be positioned in this station A transport unit automatically moves them from the plate compartment to the correct position where they are processed further Loading Unloading see chapter 5 on page 5 1 2 2 4 Test Plate Compartment with Bar Code Scanner See see figure 2 2 position 4 or figure 2 5 position 4 CAUTION Laser radiation do not stare into beam The bar code scanner is located on the left side at the front of the test plate compart ment The test plate compartment can be opened only on request by the software The LED indicator LD lights up green Open the door and place the respective bar coded test plat
16. 44 53 52 Reagent level is low Refill the reagent bottle Call service 44 52 41 Aspirate pump error Call service 44 52 44 Dispense pump error Call service 44 52 57 Waste pump error Call service 44 56 Valve error Call service 44 57 EEPROM error Call service Table 7 5 Module 44 Washer Module 45 Incubator e Cause Action 45 41 Argument error Call service 45 48 nn Heater error nn shows the incubator Call service group number 45 4B 43 Shake calibration failed Call service 45 4B 52 Shake position frequency out of range Call service 45 4B 54 Shake position edge timeout Call service 45 4B 49 Shake override Call service 45 50 Plate carrier sensor error Call service 45 54 nn Temperature sensor error nn shows the Call service sensor number or name 45 57 EEPROM error Call service Table 7 6 Module 45 Incubator 7 8 ELISYS QUATTRO User Manual HUMAN Technical Data System Overview Number of plates Number of samples Number of reagents Controls amp Standards Dilution area Number of tips Loading Photometer Spectral range Dynamic range Accuracy Linearity Detection Reading time Read modes Filters ELISYS QUATTRO User Manual HUMAN Technical Data Up to 4 plates at once Max 200 tubes 16 mm Depending on rack configuration Depending on rack configuration For up to 152 dilution tubes Up to 5 tip racks for 300 ul or 1100 ul disposable tips Continuous loading of plates
17. 5 Combined Report The Combined Report shows all patient IDs results flags etc in one table It gives a short over view about all relevant data The samples are identified by the patient ID The individual wells are identified alphanumerically evaluated calculated and if necessary flagged 4 5 1 6 Validation Criteria The window Validation Criteria indicates if the control values of the test meet the defaulted cri teria If the values of the control well are within the limits specified by the formula in this field the test is con sidered valid and can therefore be evaluated If one of the criterias is failed the test will not be evaluated 4 5 1 7 Qualitative Results The window Qualitative Results provides information regarding the cut off value of the test Three options are available Pos positive result Neg negative result result in the greygreygrey range 4 5 1 8 Events The Events window shows information on impor tant actions performed by the analyzer and subse quent reactions by the user Important actions in this context are warning and error messages they are displayed in red Reactions by the user on these actions are dis played in green User actions such as manual definition of rea gents are also displayed in red 4 22 ELISYS QUATTRO User Manual HUMAN 4 5 1 9 Lot Specific Values The window Lot Specific Values if selected in the assay protocol include
18. 6 2 3 4 Photometer Back of Bottom 2 7 2 4 Other Instrument Modules 2 7 2 4 1 Guide Rail for Pipettor 2 7 2 4 2 Pipettor Z Direction 2 8 2 5 Connections 2 ss IDE ANE Aa a res dH 2 8 2 0 LED DiSpliys exeun 2 9 2 7 Principles of 2 11 2 7 1 Absorbance 2 11 2 7 2 Bichromatic Measurement 2 11 3 Software Structure and Operation 3 1 3 4 Basic Information about Operation 3 1 3 2 3 2 3 2 1 General Menu 3 2 3 2 2 Worklist Menu Guidance 3 4 3 2 3 Result Menu 3 5 3 3 File TyDes o oe cde cw ee Re a RE eee 3 6 4 Performing a Test Run 4 1 ELISYS QUATTRO User Manual HUMAN TOC 1 TOC 2 4 1 System Start dew etacei eR REM 4 1 42 Input of Patient 4 2 4 2 1 Manual Input of Patient 4 2 4 2 2 Input of Bar Coded Patient 4 4 43 Worklist Definition 4 5
19. Back of Bottom Drawer See figure 2 5 position 7 The photometer 400 700 nm is installed at the back of the bottom drawer The photometer can be equipped with up to 8 filters end point or kinetic evaluation pos sible The photometer is moved out with the bottom drawer 2 4 Other Instrument Modules 2 4 1 Guide Rail for Pipettor See figure 2 1 position 8 It is used to move the pipettor in the X and Y direction ELISYS QUATTRO User Manual HUMAN 2 7 System Basics 2 4 2 Pipettor Z Direction See figure 2 1 position 9 The pipettor includes a complex sensory mechanism It works with disposable tips The pipettor is connected to the system liquid port See figure 2 6 position 10 via tubing A plastic cover with hinged flap protects the visible working area The closed position of this flap is monitored by a contact switch The ELISYS QUATTRO cannot be operated without this cover or flap in order to avoid getting in contact with the working area during a run If these safety precautions are not observed strictly the operator may get hurt or contract an infection or the instrument may get damaged The system will stop immediately when the instrument cover or the lockable flap is opened during a run 2 5 Connections Xi 12 18
20. Load Tip Racks 0 5 1 5 1 5 Load Sample and Reagent 5 2 5 1 6 Load Test Plates ssl epa a 5 5 5 2 Unloading racic i gx ee eee eee EP a ee say eS 5 6 5 2 1 Remove Dilution Tubes Take Tip Racks off 5 6 5 2 2 Remove Racks with Patient Samples and Reagents 5 6 5 2 3 Remove Test 5 6 5 3 Disposal mne REA aad con an amp aie S RE 5 7 5 3 1 Liquid Waste from Pipettor and Wash Unit 5 7 5 3 2 Disposable lt 5 5 7 5 3 3 Replace Waste Container for Disposable Tips 5 7 5 3 4 Disposal of 5 5 7 5 3 5 Disposal of Packaging 5 7 Service and Maintenance 6 1 6 1 Maintenance 6 1 6 1 1 Daily Maintenance 6 1 6 1 2 Weekly Maintenance Procedure 6 1 6 1 3 Monthly Maintenance 6 2 6 2 parce Plan to be performed by authorised Service Engineers 6 6 3 Cleaning and Disinfecting the Instrument 6 4 6 3 1 Cleaning and Disinfecting the Housing Surface 6 5 6 3 2 Cleaning and Disinfecting the Interior of the Instrument 6 5
21. Not loaded CYTO_IgM 5 E Active event log Job list Archiving 1 101141 Ei For Help press F1 IL tis Phoenix Work9 Ele Edit View Utiities Window 18 x s a Ge gt m w 15 16 17 ist parameters 1 1 e Pipette I y layouts asher L Qo Reagent requirements Colorimeter CJ system status Incubator 1 E Active event log incubator 2 Job list incubator 3 Archiving Incubator 4 Plate transport EI Mill dditional resources ditional plates Bl Plate 1 Bl Plate 2 joj Lal E For Help press F1 Performing a Test Run 4 4 1 2 Plate Layout The Plate layout shows the exact plate layout All plate layouts defined in the current worklist are CoE 28151 5 Eie Edit View Utiities Window l x displayed one below the other ae EN The view can be switched between Layout EI QM Label e g T1 2 and Patient IDs 9 abcr arua 8 7 e 9 9 n m 318261 513255 Bree e Cae pee 0 F S4 S4 IG T 1 2 T2 Plate 2 CYTO IgM 1 a 4 5 6 7 8 9 10 11 12 B1 T4 T5 Ic Cot ID Cot F T I T2 3 Jollet For Help press F1 NUM 4 4 1 3 Reagent Requirements The Reagent requirements shows the required reagents Exa
22. Reagents Unit with Bar Code Reader See figure 2 2 position 2 CAUTION Laser radiation do not stare into beam The bar code scanner is located on the right side at the front of the patient sample and reagent unit The patient sample and reagent unit accessible via a flap includes 12 tracks for sample and reagent racks The following racks are supplied T Sample rack for 20 patient samples occupies one track Reagent rack for 18 bottles for reagents occupies 1 tracks 5 Reagent rack for 5 large bottles for reagents and 8 small bottles for reagents occupies 3 tracks Each rack includes a contact pin on racks occupying one track this pin is located at the top centre and on the broader racks at the top right The software specifies which track is to be used for the respective rack This is indi cated by a red LED A reagent rack occupying 3 tracks must be inserted such that the contact tappet is in contact with the lit up LED Each rack has to be inserted up to the limit stop The respective LED on the rear pan el goes off Loading Unloading see chapter 5 on page 5 1 Reloading of patient and reagent racks is possible when the instrument is in the in cubation mode Keep the flap of this unit closed during a run It may be opened only for re loading see chapter 5 2 on page 5 6 Opening the flap while transfer steps are being performed results in an immediate stop of the pipettor and entry in the event log 2
23. Schedule The maintenance work described below has to be performed by the user whenever necessary at least however in the intervals specified below 6 1 1 Daily Maintenance Procedure Start up 1 Check the system liquid container level 2 Empty and clean the waste container for tips see chapter 5 3 3 on page 5 7 3 Check the waste container liquid level empty and clean if necessary 4 Check the level of washing solution and distilld water in the washer bottle 5 Check the needles of the washing head and clean using the cleaning tools if necessary 6 Clean the instrument surface if necessary 7 Start the system first and then the Computer 8 Start the Phoenix software only when the RDY LED on the instrument is ON 9 Perform the selftest The selftest starts and will be executed automatically 10 Check if selftest is passed End of work 1 Close the finished worklist 2 Close the Phoenix software 3 Close Windows 95 2000 and shut off computer monitor and printer 4 Switch the ELISYS QUATTRO off 5 Remove reagent and patient racks 6 Remove all used dilution tubes 6 1 2 Weekly Maintenance Procedure Procedure 1 Change the system liquid fluid Where disinfecting is required use always alcoholic type 2 Clean the following areas ELISYS QUATTRO User Manual HUMAN 6 1 Service and Maintenance 6 2 Dilution area Reagent and patient rack area Pipetting station Pipettor wash station Tip eject stati
24. Stop button has been pushed during a run The run has been interrupted and may be continued or aborted completely Aborting plate 1 The run of the plate has been aborted Reasons The Stop but ton has been pushed The run has been interrupted and may be continued or aborted completely Bar code IC error The bar code cannot be read Verify the readability of the bar codes Check the bar code parameters in the Setup menu Try reading the bar codes once more If these attempts fail call service Clot detected in rea gent 1 Clots were detected in reagent 1 Abort the run if necessary and replace reagent Colorimeter 1 not homed The X motor of the photometer is not in the home position Select the menu item Utilities Selftest to initialise the system again If the problem recurs call serv ice If this error message comes up dur ing a run this run has to be aborted Colorimeter A D error Error of the analog digital converter of the photometer Call service Colorimeter A D over range error Upper limit of photometer A D has been exceeded due to the signal height of the preselected resolution The filter has not been installed prop erly Call service Colorimeter A D under range error Signal detection too low Defect of power supply unit of the photometer or something similar The halogen lamp of the colorimeter is faulty and has to be replaced If the
25. applicable rated pollution degree 15 C to 25 C Conformity The following technical tests were carried out Safety regulations tests EN 61010 1 EMC Test for electromagnetic compatibility EN 61326 Values are archived under optimal conditions and can vary depending on en vironmental conditions instrumental status and processing conditions ELISYS QUATTRO User Manual HUMAN Technical Data ELISYS QUATTRO User Manual HUMAN 8 5 HUMAN Gesellschaft f r Biochemica und Diagnostica mbH Max Planck Ring 21 65205 Wiesbaden Germany Tel 49 61 22 99 88 0 Fax 49 61 22 99 88 100 e Mail humanghuman de www human de
26. be re moved Use of controls or adjustments or performance of procedures other than those A specified herein may result in hazardous radiation exposure 1 2 4 Mechanical Safety Do not place the instrument on a unstable table cart or similar The instrument may fall causing serious damage to the system or injure the user ELISYS QUATTRO User Manual HUMAN 1 5 Intended Use 1 6 Don t load the complete opened drawer The instrument could tip forward Never open screw attached housing parts while the instrument is on There is a risk of injury due to moving parts fan motor drives Only when directed to do so should power be applied If power is applied while any covers are removed use extreme caution while servicing the system Do not take off the protective cover during a run and do not reach into the working area Improper handling may cause serious damage to the instrument or injure the user If you open the flap or cover verify that the movement of the pipettorhas stopped be fore you reach in the working area Avoid touching the pipettorand other moving parts while the system is in operation Notice that it is possible that the instrument continues processes independently even without computer Slots and openings are provided for ventilation To ensure reliable operation of the instrument and to protect from overheating these openings must not be blocked or covered 1 2 5 Biological Safety
27. closed System cover opened Message instrument cover is opened Close cover otherweise the system can not start processing a worklist System fluid low System fluid for pipettor too low Fill up system fluid container with de ionized water The plate transport cannot find a route from its current posi tion to its next desti nation Plate transport has no information about its present position Select the menu item Utilities Selftest to initialise the system again If the error persists call service Tip eject failure Error in the tip eject station Remove tip manually from the pipettor or trigger the eject mechanism manu ally If this error recurs call service Unknown colorimeter Unknown photometer error Call service error code 1 Unknown incubator Unknown incubator error Call service error code 1 Unknown plate trans Unknown plate transport error Call service port error code 1 Unknown washer Unknown washer error Call service error code 1 7 4 ELISYS QUATTRO User Manual HUMAN Error Messages Error Cause Action Verification failed 1 The reader has failed the validation criteria Replace the photometer lamp Repeat validation If this error persists call service Washer 1 motor not homed Error in washer motor Select the menu item Utilities Selftest to initialise the system again If the error per
28. goes off and jumps to the next position that can be loaded A red flashing LED indicates that the rack wasn t identified correctly Pull out the rack and insert it once more A graphical representation of the correctly inserted rack appears on the screen From the pool of unallocated resources in the right hand side of the screen the loaded reagents are allocated to the rack in accordance with the identified loading Place the mouse pointer on the reagent to check the ID 3 Insert the next racks as described The software shows all resources prior to allocation in the area Unallocated re sources in their respective colour as defined in the reagent database All automatically allocated samples and reagents are crossed all manually al located samples and reagents are not crossed Loaded reagents which are identified by a bar code and which are not needed for the current worklist are presented in black Reagents that have not been identified are not displayed in the reagent area the po sition remains white The symbols of these reagents can be allocated from the area Unallocated resources to the respective positions with the mouse Wil See notes on page 5 2 ELISYS QUATTRO User Manual HUMAN 5 3 Loading Unloading Disposal 5 1 5 2 Load Patient Sample Racks with Bar Coded Samples 1 Insert the rack on that track that is marked by the red LED on the rear panel Place rack in front of the track and then push evenly up to th
29. is full Empty the system waste container Table 7 2 Module 41 Virtual module Module 42 Plate transport Module Error Cause Action ID number 42 41 Argument error in command Check that the firmware is the correct version for the version of software being run 42 42 Plate transport bar code IC error Replace the plate transport barcode scanner 42 42 43 The plate bar code scanned was not Replace the plate with the correct one what was expected 42 44 Plate load unload door is open while try Close the plate load unload door Check ing to move the connectors to the switch 42 48 nn Motor not home nn shows the position None The software will reset the plate transport and try again 7 6 ELISYS QUATTRO User Manual HUMAN Error Messages Module Error Cause Action ID number 42 4D nn Motor jammed during movement nn Call service shows the axis 42 50 Plate carrier sensor failure Call service 42 52 Firmware was unable to compute a safe Call service route between the two positions 42 57 EEPROM error Call service Table 7 3 Module 42 Plate transport Module 43 Photometer Module Error Cause Action ID number 43 41 Argument error in command Check that the firmware is the correct version for the version of software being run Call service 43 42 Background light levels too high Check position of lam
30. prescribed herein e g microplates tubes disposable tips etc The manufacturer assumes no liability for any damages including those to third par ties caused by improper use or handling of the system ELISYS QUATTRO User Manual HUMAN 1 3 Intended Use The operator may only perform the maintenance work described in this manu al Use only the parts prescribed in this manual for servicing The tests and maintenance work defined by the manufacturer should be performed to make sure that the operator remains safe and that the instrument continues to function correctly Any service and maintenance work not described in this manual must be performed by authorised service personnel and technicians Any changes on the system which are not authorised by the manufacturer lead to the loss of guarantee obligation The system was developed and tested according to the regulations of the IvD directive Any changes on the system which are not authorised by the manufacturer lead to the loss of the validity of the conformity with the applicable regulations the manufacturer has declared In this case the customer is responsible for the fulfilment of the appli cable regulations The instrument should be opened serviced and repaired by qualified and au thorised service personnel only 1 2 2 Electrical Safety Country specific regulations regarding safe electrical operation of the in stalled system have to be observed Check tha
31. the windows Assay Protocol To define assay process steps pipetting washing incubating measurement etc Panel Definition Set up Panel To combine assays and samples on test plates to create a worklist for routine Worklist To check the conditions for a certain worklist ELISYS QUATTRO User Manual HUMAN 3 1 Software Structure and Operation 3 2 Menu Guidance 3 2 1 General Menu Guidance Menu Item Icon Function File New Creates a new file e g a worklist or an assay 3 The New dialogue box opens and the follow ing file types can be selected Assay Work list Spectral Response Patient Results Report QA Analysis Report Job List New Worklist Creates a new worklist Open Opens an existing file e g an assay protocol or a report file file types see File New Close Closes the displayed file Save Saves the active file e g worklist report IN Save As Saves active file e g worklist report under a new name Print Prints the active document e Print Preview Shows the active document as print preview Print Setup Defines the printer and printing options Recent Protocols Shows the last opened and already saved gt assay protocol files for selection Recent Results gt Shows the last opened and already saved result files for selection Recent Worklists Shows the last opened and already saved gt worklist win
32. 1 2 2 Electrical Safety 0 cece eee iR eee 1 4 122 3 Laser Safety 4 ul nay baa Bigs date ERU eR aO RR 1 5 1 2 4 Mechanical Safety 1 5 1 2 5 Biological 1 6 1 2 6 Cleaning the 1 6 12227 4 8 RM 8 oa ete ee ae Ne E 1 7 1 3 Positions of Safety Labels and Type Label 1 7 1 3 1 General Warning 1 7 1 3 2 Biological Hazard Labels 1 7 1 3 3 Electrical Hazard 5 1 8 1 3 4 Laser Hazard 1 8 1 9 5 Type Label b ERBEN Ronee ee 1 8 2 System Basics cic 2a e te ek Rip 2 1 2 1 OVerviow Ha on eee eta le een ee PRRE ERA eee 2 1 2 2 Level Instrument 2 2 2 2 1 Tray for Tip Racks and Pre dilution 2 3 2 2 2 Patient Sample and Reagents Unit with Bar Code Reader 2 4 2 2 3 Tip Ejection Station Pipettor Wash Station Pipetting Station 2 4 2 2 4 Test Plate Compartment with Bar Code Scanner 2 5 2 3 Drawer Instrument 2 5 2 3 1 Wash Buffer Container and Waste Bottles 2 6 2 3 2 Wash Unit for Test Plates with Window 2 6 2 3 3 Incubator Unit lille 2
33. 4 3 1 Create New Worklist 4 5 4 3 2 Defining Several Assays per 4 7 4 3 3 Defining Several 4 8 4 3 4 Input of Reagent 4 8 44 StartaWorklist ie eene re aie 4 9 4 4 1 The Worklist 4 9 4 4 2 Loading Samples and 4 12 4 4 3 Loading other Required 4 15 4 4 4 Reagent Volume 4 16 4 4 5 Plate 4 17 4 4 6 Starting and Processing a Run 4 18 4 4 7 Pausing or Cancelling a 4 20 4 5 lt 4 20 4 5 1 Results 4 21 46 Re Loading 9 o iic ice e ER Re EE LS 4 23 4 7 Quality Control Analysis Report Levey Jennings Plot 4 25 48 Patient Result 4 25 Loading Unloading Disposal 5 1 5 4 Loading Instrument at 5 1 5 1 1 Refill System 5 1 5 1 2 Refill Wash Liquid 0 00 00 eee ee 5 1 5 1 3 Position Dilution 5 1 5 1 4
34. Ds in the Explorer tree Change the order of plates via the Move Up and Move Down buttons 4 3 4 1 After all required plates have been defined in the Set up Panel dialogue box click OK to close the dialogue box TheLot Specific Values For Plate 1 dialogue box for of the active worklist is dis played It includes a tab for each assigned assay listing the required reagents for the respective assay 2 For this assay and if available for the other assays on this plate that are located on further tabs you have to enter the lot specific data 3 Click on the OK button The first assay of the next plate is displayed This and possibly following assays and plates have to be treated as described above After the last plate the Worklist window is dis played see next chapter 4 8 Defining Several Plates Input of Reagent Data xi E ES Plate 2 CYTO_loM 4 f AERE ASE ESY aps A B1 T4 INCI T5 E cot D 01 E PC1 F T1 B T2 H T3 IV Start assay with a new strip Edit Layout Open Panel Save Panel Patient Details Cancel x CYTO9G RUBE 106 Batch Numbers Batch Name Batch Number Expiry Date QA Label CYTO IgG Conjugate Fl CYTO49G 590 PVT Na Ste Add Remove Assay Protocol Parameters Value 0 Cancel Appl
35. ELISYS OUATTRO User Manual CE Cat No 16300 1 Human PN Edition Rev DATE REVISION DESCRIPTION 01 2004 12 First edition 02 2011 01 Update cover and back page System Manufacturer HUMAN Gesellschaft fur Biochemica und Diagnostica mbH Software copy The ELISYS QUATTRO software is the intellectual property of HUMAN GmbH rights Intellectual property rights shall remain with HUMAN GmbH You are entitled to use the ELISYS QUATTRO software and the printed accompany ing material at your place of work only Any violations of property rights or copyright or trademark may be subject to legal action Copyright 2010 HUMAN GmbH All rights reserved HUMAN Gesellschaft f r Biochemica und Diagnostica mbH Max Planck Ring 21 D 65205 Wiesbaden GERMANY Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of HUMAN GmbH Table of Contents 1 Intended Use ou tebe see oa Seek 1 1 1 4 Typographical 1 1 1 1 1 Warning 1 1 1 1 2 Notes nde or UE ean ner EAE es SORES S ER 1 2 1 4 3 Symbol repe eve pe 1 2 1 1 4 Special 1 2 1 2 5 1 3 1 2 1 General Safety 1 3
36. Risk of infection Handling of samples and reagents Avoid contact between skin mucous membrane and samples test reagents or parts of the instrument which were in contact with samples test reagents The above mentioned parts are to be treated as being potentially infectious Reagents can lead to irritation of the skin and mucous membranes Use appropriate gloves Observe the instructions in the package inserts for a correct use of the reagents If sample material is spilled in the system clean and disinfect it immediately by the use of a validated method For reagent containers and tubings system liquid and waste no guarantee can be provided for any resistance against organic solvents For this reason do not use any organic solvents unless such solvents are expressly authorised It is not possible to autoclave the containers for liquids and waste 1 2 6 Cleaning the System Switch the instrument off and disconnect it from the mains supply before cleaning disinfection or decontamination ELISYS QUATTRO User Manual HUMAN Intended Use Liquid detergents disinfectants or decontamination liquids may not be poured into the instrument or sprayed inside the system For the cleaning disinfection or decontamination a cloth moistened with detergent disinfectant or decontamination liquid should be used Only approved detergents disinfectants or decontamination liquids may be used Only approved cleaning disinfection or deconta
37. a logue box requests the 2nd plate 3 Repeat procedure until all plates of the worklist have been inserted Wil At this point the system does only recognise if a holding frame has been load ed ELISYS QUATTRO User Manual HUMAN 4 17 Performing a Test Run 4 4 6 Starting and Processing a Run As soon as all plates have been loaded the system starts the run All loading doors must be closed so HHE that the run can be started j The plates are processed in accordance with the defined process steps of the selected assays During the run all worklist options see chapter 4 4 1 on page 4 9 can be viewed In the Schedule mode the current time and thus the current operation is marked by a vertical indicator lad Additional plates gar xc Bl Plate1 Bl Plate 2 At the end of the entire run the system prompts you to unload plates Unload plates one by one Results can be viewed as soon as all plates have been unloaded 41 101141 E For Help press F1 NUM 4 4 6 1 Clot Detection Error Handling Dependent on the attitude in the test definition Raise alarm and stop Log and continue or Man ual pipette at end of step the error handling is differ ent at a clot detection Action on error Raise alarm and stop If a clot is detected the system stops and shows a message with the following buttons System Error S ki p S am p Clot detected in pati
38. ack is to be inserted When loading rea gent racks that occupy three tracks it must be ensured that the rack with its right track 7 position of contact tappet is placed on the tracks with the red LED The bar code labels must face right the bar code reader Samples having particulate matter turbity lipaemia foam or erythrocyte de bris may require clarification by filtration or centrifugation before testing The use of primary tubes with gel separator requires a careful check of the sample volume above the gel to avoid any possible errors in dispensing Never remove a rack while still in use Remove it only when the related LED is flashing If a sample rack is removed which is still in use all samples not already pipetted out of this rack will be flagged with Removed and not cal culated ELISYS QUATTRO User Manual HUMAN Loading Unloading Disposal If reagents were not identified or placed without barcode the user has to make sure that the manually allocated positions correspond to the actual placement on the reagent rack Manually allocated reagents are identified in the result printout and in the log file 5 1 5 1 Loading Reagent Racks 1 Insert rack on that track that is marked by the red LED on the rear panel Place rack in front of the track and then push evenly up to the limit stop with the pin in the contact pin hole on the rear panel The bar code labels must face right towards the bar code scanner 2 The LED
39. ame in the First E x 4 Optionally consecutive sample numbering may be entered blockwise To do this the number of Fist patient ID 318261 the following samples has to be entered in the Number of patients 10 Cancel Number of patients text box The software Help numbers the following samples con secutively 5 Click on the OK button ER The patient editor only accepts letters and numbers as patient ID The use of r n ym n np m n n any spe cial characters such as 96 erm nm mn mn nor when creating a patient ID or receiving from the host computer is forbidden 4 2 ELISYS QUATTRO User Manual HUMAN The software returns to the Patient Editor and shows the patients that were entered new Repeat this step if necessary for further patient IDs 6 Click on the Add Test s button in the Patient Editor 7 Inthe following Add Tests dialogue assign the patients to the assays To do this select the patients and then the assay s 8 Click on the OK button Performing a Test Run Patient Editor x Sort Order 281 Patients C 318261 Ascending 318262 d 318263 Descending 318264 Uu 318265 318266 318267 23 318268 318269 Add 318270 x Select Assay s Select Patient s 1 Qualasy a CYTO IgG asy CYTO IgG2cal asy CYTO IgM asy HSY 1 2 IgG asy HSY 1 2 lgM asy HSV 2 IgG asy
40. are performed at two wavelength the measuring and the reference wavelength The measuring wavelength is close to the absorbance maximum of the chromogen The absorbance is mainly dependent on the amount of chromogenic substance in the sample The reference wavelength lies outside the absorbance range of the chromogen and indi cates the blank value of the sample The absorbance value of the reference wave length is subtracted from the absorbance value of the measuring wavelength In this manner external influences such as scratches on the microtiter plate dust turbidity of the solution and the drift of the electronic measuring instrument can be compen sated ELISYS QUATTRO User Manual HUMAN 2 11 System Basics 2 12 ELISYS QUATTRO User Manual HUMAN Software Structure and Operation 3 Software Structure and Operation 3 1 Basic Information about Operation ELISYS QUATTRO The user program Phoenix is a PC program running under Microsoft Windows 95 as well as Windows 2000 The usual Windows conventions apply Deviations from these conventions are described where appropriate Explorer Tree Some windows show an explorer tree on the left hand side and the selected item on the right hand side Clicking on the plus sign of a folder on the explorer tree opens the respective options clicking on the minus sign closes the respective folder Click ing on an item shows the respective page of the corresponding file This presentation is used for
41. assay protocol is displayed as a folder 4 6 Click on the Add Patient button to assign the patients to the selected assay The Select Patient s dialogue box appears It contains only the patient IDs for which the respective assay has been selected in the Patient Editor The dialogue indicates all patients with a which are already loaded on the instrument Select patients with the mouse or press on the Select All button to select all of the loaded samples to the worklist Click on the button Loki C4asms _ dengam CYTO IgG2cal asy je CYTO IgM asy a EA IgG Qual asy je EA IgG Quant asy je EBNA IgG Qual asy je EBNA IgG Quant asy AL xl Anti HCV Ortho asy Anti HCV asy Anti HD asy je EBY IgM Qual asy je EBV IgM Quant asy a Eti Syphilis IgG asy a Eti Syphilis IgM asy a HBeAg asy a HBsAg asy CYTO IgG Qual asy a CYTO IgG asy n Files of type assay Protocol Files asy bd Cancel Open as read only x Plate 1 r Plate 1 CYTO lgG 3 CYTO 49G Gli gt f Rdd Ass 1 Add Patient 8120 Cjs1 Edi D 52 Duis 53 F s4 Move U G H Undo Bedo IV Start assay with a new strip Edit Layout Open Panel Save Panel Patient Details OK Cancel Help Select All
42. colours in the top right corner of the screen You can view the respective name by moving the cursor over these circles Auto Arrange Samples Open Reagent Layout Redraw Unallocated Resources Scannet Setup _ Save Reagent Layout Help ELISYS QUATTRO User Manual HUMAN 4 13 Performing a Test Run Ww N gt Right LED lights up red Insert first rack into the right track Allocate the non bar coded reagents on the Screen by dragging the mouse corresponding to the actual loading to the reagent rack Each dot clearly corresponds to one reagent Insert the required racks one by one into the tracks marked by the red LED and allocate the resources as described above from right to left On the screen allocate the samples by dragging the mouse corresponding to the actual loading to the sample racks Each dot clearly corre sponds to one patient tube or one reagent mouse button again Auto Arrange Samples Load procedure 1 Load all sample racks and press on the Auto Arrange button The fill direction of the sam ples starts at position one of the rack placed in the far left side Load procedure 2 Load the first sample rack and press on the Auto Arrange button The fill direction of the samples starts at position one of the sample rack just inserted Proceed this sequence with the remaining racks
43. dow for selection Exit Terminates the program View Toolbar Shows hides toolbar Status Bar Shows hides status bar at the bottom of the screen Utilities System Setup Definition of instrument parameters Selftest Performance of a selftest initialisation Verify Checks the photometer 3 2 ELISYS QUATTRO User Manual HUMAN Software Structure and Operation Menu Item Icon Function Patient Details Definition of detailed patient data Options Definition of software parameters Window New Window Opens a new window Cascade Cascades the active windows Tile Tiles the active windows Arrange Icons The icons can be re arranged A Shows the names of all currently active win dows Help Help Topics Calls on line help About Phoenix Shows the version number of the Phoenix soft ware Table 3 1 General menu guidance ELISYS QUATTRO User Manual HUMAN 3 3 Software Structure and Operation 3 2 2 Worklist Menu Guidance Menu Item Icon Function Edit Panel Definition Opens the Set up Panel dialogue box only possible with open worklist with editing options of the current worklist Panel Options Settings for processing the worklist Optimise Optimises processing of the defined run Lot specific values Display and input of the lot specific information nj and the required reagents for the displayed
44. dt Window Help 15 x Patient ID Assay s 318251 CYTO4gG RUBE IgG CYTO IgM 182820 CYTO gG RUBE IgG CYTO IgM 18263 CYTO gG RUBElgG CYTO 18264 CYTO gG RUBElgG CYTO IgM 18265 CYTO gG RUBElgG CYTO IgM Kil 11141 E For Help press F1 4 4 2 Loading Samples and Reagents CAUTION Laser radiation do not stare into beam Allocate the vials only into suitable locations An incorrect allocation may cause errors in dispensing Samples having particulate matter turbity lipaemia foam or erythrocyte de bris may require clarification by filtration or centrifugation before testing The use of primary tubes with gel separator requires a careful check of the sample volume above the gel to avoid any possible errors in dispensing When refilling a reagent bottle never exceed the bottle shoulder An over fill ing may lead to an incorrect dispensing ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 4 2 1 Loading Bar Coded Patient Samples and Reagents The sample and reagent area on the screen are empty xj The required resources are displayed as circles in different colours the top right corner of the screen ogre You can view the respective name by moving the cursor over these circles An inserted rack is depicted graphically a
45. e limit stop with the pin in the contact opening on the rear panel The LED goes off and jumps to the next position that can be loaded A red flashing LED indicates that the rack was not identified correctly Pull out the rack and insert it once more A graphical representation of the correctly inserted rack appears on the screen From the pool of unallocated resources in the right hand side of the screen the loaded samples are allocated to the rack in accordance with the identified loading Place the mouse pointer on the sample to check the patient ID Insert the next racks as described After loading close the flap again audible click See notes on page 5 2 5 1 5 3 Load Patient Sample Racks without Bar Coded Samples 1 Insert the rack on that track that is marked by the red LED on the rear panel Place rack in front of the track and then push evenly up to the limit stop with the tappet in the contact opening on the rear panel 2 The LED goes off and the rack type is identified by the bar code scanner and depicted on the screen with empty sample positions 3 Insert the next racks in the track marked by the red LED 4 Once you have loaded all racks distribute the unallocated samples displayed on the screen on the individual rack positions with the mouse in accordance with the identified loading 5 Close the flap again audible click See notes on page 5 2 ELISYS QUATTRO User Manual HUMAN Loading Unloading Disposal
46. e with the holding frame onto the transport unit so that both pins of the holding frame sit in the openings of the slide Position A1 is at the top left see figure 2 4 The plate is moved to the pipetting station following the respective command on the screen gt a eec eed 4 4 a d OE QOOOO0O0 0000000 Figure 2 4 Inserting a test plate with holding frame From there the plate is transported depending on the defined assay to the various instrument modules and then back again to the plate loading position Loading Unload ing see chapter 5 on page 5 1 2 3 Drawer Instrument Modules The drawer is automatically locked during a run The green LED INSTR goes off ELISYS QUATTRO User Manual HUMAN 2 5 System Basics 2 6 e e ee 4 d 5a n 5b P m es eec Figure 2 5 ELISYS QUATTRO Bottom drawer pulled out 4 Test plate compartment with plate transport unit see chapter 2 2 4 on page 2 5 5a Wash buffer container square and waste bottles round see chapter 2 3 1 on page 2 6 5b Wash unit for test plates see chapter 2 3 2 on page 2 6 6 Incubators see chapter 2 3 3 on page 2 6 7 Photom
47. ent ID The use of any spe cial characters such as Maen n n n mnn Or n 2 0335 3 when creating a patient ID or receiving from the host computer is forbidden As an alternative patients may be entered via host In this case you may start directly with creating a worklist see chapter 4 3 1 on page 4 5 test HH You will find further information to the tests in the manual of the respective ELISYS QUATTRO User Manual HUMAN 4 4 4 3 Worklist Definition 4 3 1 Create New Worklist 1 Click the New Worklist button or select File New and then select Worklist in the dialogue box 2 The Set up Panel dialogue box is displayed Incase of non bar coded samples this dialogue box is empty as shown in the figure to the right With bar coded samples a worklist with plates assays and patients is suggested in accordance with the assignment of the assays to the samples and displayed in the Explorer tree using one assay per plate Click on the OK button to accept this proposal and proceed with defining several plates see chapter 4 3 3 on page 4 8 or with input of reagent data see chapter 4 3 4 on page 4 8 If the proposal is modified the plate panel has to be deleted with Delete and a new plate panel has to be defined Inthe Set up Panel dialogue box the plate s and the plate layout are defined for the selected worklist via the top 3 buttons Click on the Undo button to undo the last
48. ent sample 000002 11 2 The pipettor moves to the eject position to RIS sues remove the tip Entry in the Eventlog The next sample will be pipetted The result file flags all samples with Clot detected where a clot was detected Abort Plate An additional message comes up to confirm the plate abort process The pipettor moves to the Eject position to remove the tip If available the next sample of the next plate will be pipetted If this error persists contact your local service centre i Abort Plate Continue Continue The sample is pipetted into the appropriate well of the micro plate The result file flags all samples with Clot detected where a clot was detected 4 18 ELISYS QUATTRO User Manual HUMAN Performing a Test Run Action on error Log and continue If a clot is detected the system does not show a message and continues with The pipettor moves to the eject position to remove the tip Entry in the Eventlog The next sample will be pipetted Theresult file flags all samples with Clot detected where a clot was detected Action on error Manual pipette at end of step If a clot is detected the system does not show a message and continues with The pipettor moves to the eject position to remove the tip Entry in the Event log The next sample will be pipetted Atthe end of the pipetting step a message comes up and sho
49. error persists the optical components in the photometer filter upper or lower optic block may be dirty Call service Colorimeter back ground light level error Typically occurs when light entered the measurement chamber Avoid direct exposure to sunlight close all housing doors and covers Select the menu item Utilities Selftest to initialise the system again ELISYS QUATTRO User Manual HUMAN 7 1 Error Messages Error Cause Action Colorimeter EEPROM error Error during EEPROM reading or writing Call service Colorimeter filter 1 error Error at filter no 1 The gain factor for the respective filter cannot be identified Filter is faulty or wrong fil ter has been installed Call service to check the installed filter and to replace it if necessary Colorimeter filter motor home error The system does not recognise the current position of the filter motor Move to the home position Select the menu item Utilities Selftest to initialise the system again Colorimeter filter motor movement error The system does not recognise the current position of the filter motor Move to the home position Select the menu item Utilities Selftest to initialise the system again Colorimeter lamp error Halogen lamp of photometer is faulty Replace the halogen lamp Colorimeter optic channel 1 error Error in one of the 9 optical chan
50. ert sample racks and allocate sample symbols with the mouse to the new sample rack see chapter 4 4 2 on page 4 12 Processed sample racks flashing red LED can be removed 7 Reagents Refill or add additionally required reagents as shown on the screen see chapter 4 4 2 on page 4 12 The reagent symbols are automatically allocated to the respective positions 8 Disposable tips and dilution plates Refill disposable tips dilution plates wash buffer and distilled water as shown on the screen see chapter 4 4 3 on page 4 15 i Allocate the vials only into suitable locations An incorrect allocation may cause errors in dispensing n When refilling a reagent bottle never exceed the bottle shoulder An over fill ing may lead to an incorrect dispensing Never remove rack while still in use Remove it only when the related LED is flashing If a sample rack is removed which is still in use all samples not already pipetted out of this rack will be flagged with Removed and not cal culated E Make sure that the flap of the reagent unit is closed after re loading 9 After loading and allocation of all required resources confirm the dialogue with OK A vol ume check of all reagents is carried out automati cally see chapter 4 4 4 on page 4 16 After the volume check the worklist is calculated new interlacing or adding new plates assays to be proc essed Further processing is then carried out in accordance with the new wor
51. essary take out the plate that may still be in the washer If the error persists call service Washer reagent level low error The wash buffer runs low Refill the wash buffer Push the Retry button Then you may continue Washer valve test error Error in testing the pump valve Valve does not switch Call service Washer waste full Container for washer waste full Empty container Washer waste pump error Error in washer waste pump Check connections and container caps for leaks If the error persists call serv ice Table 7 1 ELISYS QUATTRO User Manual HUMAN General Error Messages 7 5 Error Messages 7 2 Error Messages of Components The following error codes have been assigned to the individual system modules An error code consists of six parts IDxx03xx4552nnnn ID ID number of the module xx Insignificant 03 Error xx Insignificant e 4552 Start of the error number e nnnn Error number sometimes there are only two numbers Example 42xx03xx45524243 means Module 42 error number 4243 In the follow ing tables you find this error display under the module number and the error code Call service for errors which were not specified Module 41 Virtual Module Module Error Cause Action ID number 41 46 System fluid low Refill the system fluid container 41 57 System waste container
52. eter see chapter 2 3 4 on page 2 7 2 3 1 Wash Buffer Container and Waste Bottles See figure 2 5 position 5a A maximum of 3 bottles 1 x 1 litre 2 x 2 litres can be used for various wash buffers another position has to be reserved for the cleaning fluid distilled water to clean the washer head The connection fitting consists of 4 colour coded connection pairs one tubing and one level sensor each per bottle Loading see chapter 5 1 on page 5 1 Two waste bottles are available for the wash unit One waste bottle contains the liquid waste which is pumped to the waste container which is positioned below the instru ment The second bottle serves as overflow protection 2 3 2 Wash Unit for Test Plates with Window See figure 2 5 position 5b The test plates are moved into the wash unit by the system The wash process and the height adjustment of the washer head can be checked via the window 2 3 3 Incubator Unit See figure 2 5 position 6 ELISYS QUATTRO User Manual HUMAN System Basics Below the pipetting area for the test plates there are four independent heatable and shakeable incubator chambers the test plates are automatically transported into these incubators and out again according to the assay protocol The instrument is equipped with a light protected storage magazine accommodating four plates for room temperature incubation It is located below the incubators in front of the photometer 2 3 4 Photometer
53. fuse carrier with a screw driver ANNAR VAM 31 Figure 6 3 Fuse carrier 4 Change the faulty fuse s Fuse 4A T 250 V Figure 6 4 Fuse carrier with fuses 5 Insert the fuse carrier 6 Connect the main power T Switch on the system ELISYS QUATTRO User Manual HUMAN 6 7 Service and Maintenance 6 8 6 6 Backup of Result Files A backup of result files is recommended on regular time bases e g weekly This backup cannot be carried out directly from the Phoenix software menu Proceed as follows Open the Windows explorer Select the Phoenix folder Select the Results folder Select the result files res to save Copy them on the desired data drive D 6 7 Putting System Out of Action To put system out of action for a longer time contact your local service centre ELISYS QUATTRO User Manual HUMAN 7 Error Messages 7 1 Error Messages General Error Messages If the ELISYS QUATTRO does not work this is often due to minor problems which you can deal with by yourself This chapter describes error messages and gives instruction on error recovery 1 and 2 are placeholders for a system module or the designation of a plate a reagent or an error number System messages appear in the status bar of the Phoenix software error messages are displayed in a separate window which has to be confirmed Error Cause Action ABORT button pressed Message The
54. identified manually the posi tion in the rack has to be allocated once more see above Ifthe reagent cannot be supplied press on the Abort Worklist button This will abort any further volume check Thelgnore button skips the reagent check for this specific reagent the insufficient volumne is logged and continues with the reagent check for the next one If this error persists contact your local service centre Ignore Reagent N Do not change any reagent positions 4 16 ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 4 5 Plate Loading Plate loading may be started as soon as all reagents are available in sufficient quantity 4 4 5 1 Plate Loading The plate compartment LED lights up green the dia logue box depicted to the right appears on the moni Load Plate tor Open door and place test plate position A1 on S HE the rear left with the holding frame correctly on the s Meet plate transport unit see chapter 5 1 on page 5 1 Bn IRL 1 Enter the plate name in the field Plate ID s 2 Click on OK button ge e The test plate is first moved into the photometer to check for an adequate strip filling for the perform ance of this assay Then the plate is placed on the pipettor station The plate transport unit moves back to the home position and the Load Plate di
55. ing of pre dilution plates and tips otherwise off Right Load Green when plate compartment can be LD opened otherwise off Instrument Green when instrument drawer bottom INSTR i cae drawer see figure 2 1 position 5 can be opened 2 10 ELISYS QUATTRO User Manual HUMAN System Basics 2 7 Principles of Methods 2 7 1 Absorbance Photometry The measurement principle of absorbance photometry plays the most important role in clinical chemistry With this method the intensity of a monochromatic light beam of a suitable wavelength is compared before and after passing through a sample The degree of attenuation of intensity of the light beam provides a measure for the con centration of the substance under investigation The photometer consists of a poly chromatic or monochromatic light source In the case of the ELISYS QUATTRO this is a halogen lamp which emits a spectrum The desired wavelength is filtered out us ing a wavelength selector i e a filter The light with this wavelength passes through the sample with the substance to be measured in an optically clear solution A part of the light is absorbed in the sample The intensity of the light coming out of the sam ple is measured with a measuring cell detector The light striking the detector is converted into an electrical signal and stored as the measurement signal 2 7 2 Bichromatic Measurement In the case of the bichromatic measurement principle measurements
56. klist 4 24 ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 7 Jennings Plot The quality control analysis report Levey Jen nings plot shows the results of a selected reagent over a period of time To generate aQA Analysis Report you have to activate the QA analysis by defining QA Labels in the Lot Specific Values while preparing a worklist see chapter 4 3 4 on page 4 8 A QA Label is the label which is used in the assay layout definition e g NC NC1 PC2 etc Select File New 2 Inthe New dialogue box select the file type QA Analysis Report 3 Inthe Analysis dialogue box select in the box Controls the respective reagent 4 Select inthe box Batch Numbers the respective bach number 5 Select the period of time in the boxes Date from and to 6 Click OK to confirm the entries The system shows you the quality control analy sis report Levey Jennings plot 4 8 The patient result report shows a compact summary of the patient results of all selected assays Select File New 2 Inthe New dialogue box select the file type Patient Result Report 3 Inthe Patient Result dialogue box select All Patients or IDs between If you selected IDs between than enter the first ID and the last ID in the two boxes 4 Select up to five assays 5 Select the period of time in the boxes Date from and Date to ELISYS QUATTRO User Manual HUMAN Qualit
57. ll Wash Liquid 1 Hold bottom drawer with both hands at the bottom edge and pull it out The LED INSTR must light up green 2 Open cap of wash container and refill the respective liquid or replace bottle 3 Close cap again and watch for correct seat of level sensor and connections 4 Close bottom drawer again so it clicks into place audible click 5 1 3 Position Dilution Plates 1 Pull very left drawer out The LED DWR must light up green 2 Place dilution plate s in the respective positions as shown in the Load dia logue box The position 1 is on the rear 3 Push in drawer again up to the limit stop audible click overcoming a slight resistance 5 1 4 Load Tip Racks 1 Pull very left drawer out The LED DWR must light up green 2 Place tip rack as illustrated in the drawing below into the holding device of the instrument so that the pin sits in the groove of the tip rack 3 Push in drawer up to the limit stop audible click overcoming a slight resist ance i Please carefully check the tip racks allocation following the specific colour code and type in the software A tip misplaced can not be recognized by the instrument and may cause mechanical damage ELISYS QUATTRO User Manual HUMAN 5 1 Loading Unloading Disposal Pin Groove al Figure 5 1 Inserting a tip rack 5 1 5 Load Sample and Reagent Racks CAUTION Laser radiation do not stare into beam The red LED indicates the track where the r
58. mination methods may be used For cleaning disinfection or decontamination the regulations of the local authorities must be observed 1 2 7 Disposal Potential infectious material and all parts that may come in contact with poten A tial infectious material must be disposed according to national legislation All parts which have been replaced must be disposed according to national legislation Disposal of the instrument according to national legislation Disposal of the packaging material according to national legislation Containers intended for single strip use may not be used repeatedly 1 3 Positions of Safety Labels and Type Label If any label gets lost replace it by an equivalent label 1 3 1 General Warning Labels General waring labels are positioned on Patient sample and rack unit flap gt 1 3 2 Biological Hazard Labels Biological hazard labels are positioned on A Waste bag cover Waste container Waste bottles positioned the drawer ELISYS QUATTRO User Manual HUMAN 1 7 Intended Use 1 3 3 Electrical Hazard Labels Electrical hazard labels are positioned on Rear side of the instrument near the mains switch 1 3 4 Laser Hazard Labels Laser hazard labels are positioned on Patient sample and reagent unit bar code scanner the right side at the front Test plate compartment near the bar code scanner on the left side at the front 1 3 5 Type Label The
59. mple 28151 file Edit Utilities Window Help 181 xi Make sure the required reagents are available and n t slul ala there is sufficient space in the liquid waste container Forge peine Pee Mich Sample Dien CYTO IgG 5140 0 2 2 0 CYTO IgG 5191 0 2 2 0 event log CYTO IgG Std2 0 2m 2 0 Job list CYTO IgG Std3 0 2ml 2 0 Archiving CYTO IgG Std4 0 2m 2 0 RUBE IgG 5190 0 2 2 0 RUBE IgG 5191 0 2 2 0 RUBE IgG Std2 0 2 2 0 RUBE IgG Std3 0 2 2 0 RUBE IgG 5104 0 2 2 0 CYTO IgG Conjugate 30ml 16 0ml RUBE IgG Conjugate 30ml 16 0ml Substrate Sorin 7 2ml 16 0ml Stop Sorin 11 4ml 60 0m CYTO IgM Neg Ctrl 0 2ml 20 CYTO IgM COC Ctrl 0 3ml 20 CYTO IgM Pos Ctrl 0 2ml 20 CYTO IgM Conjugate 29ml 18 0ml Position Reagent Required Left Clean Fluid 328 0ml 1000 0ml Wash Sorin 768 0ml 2000 0ml Jot lal For Help press F1 4 10 ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 4 1 4 System Status The System status shows the working area including status messages Depending the type of sre E HIE loading bar coded non bar coded samples or host m TE connection this presentation differs TOM f m 770 coded samples Pets
60. nd the loaded resources are automatically allocated O Auto Arrange Samples Open Reagent Layout Redraw Unallocated Resources Scanner Setup Save Reagent Layout Ecol Cancel Help Right LED lights up red 2 Insert first rack into the right track 3 The bar codes are read the rack and the available reagents are identified 4 If the rack has been inserted properly up to the limit stop the LED goes off On the screen the 1100 loaded resources from the pool of unallocated resources are allocated to the inserted rack marked with a cross in the rack position since they are bar coded and are therefore identified 5 The next empty track is marked by a red LED P Proceed as described in the preceding step see B 0 I Wer Open Reagent Layout Redraw Unallocated Resources chapter 5 on page 5 1 GU Gear ox eo Ooooooeeeococceocoo oooeeeo ooooooeee 0000000000000088808 n Always load racks from right to left 4 4 2 2 Allocation of Non bar Coded Reagents and Samples The sample and reagent area on the screen is empty x After insertion of the racks only the rack types with LL empty positions are depicted Unallocated but ogre required resources are displayed as circles in differ ent
61. nformation regarding the number and position of the available tips is stored in the Phoe nix software and this information is used for the subsequent run 3 Push drawer in again audible click 5 2 2 Remove Racks with Patient Samples and Reagents 1 As soon as a LED starts flashing the respective rack can be removed Never remove a rack while still in use Remove it only when the related LED is flashing If a sample rack is removed which is still in use all samples not already pipetted out of this rack will be flagged with Removed and not cal culated 2 Open flap see figure 2 1 on page 2 1 3 Pull racks out 4 After removal close flap again audible click 5 2 3 Remove Test Plate 1 Open flap The plate transport unit with the test plate is already in a position directly next to the plate compartment 2 Remove plate with holding frame and take plate off the holding frame 3 Close flap again audible click 4 Process plate further manually or dispose off plate ELISYS QUATTRO User Manual HUMAN Loading Unloading Disposal 5 3 Disposal 5 3 1 Liquid Waste from Pipettor and Wash Unit 1 Open screw cap on liquid waste container Dispose liquid waste in accordance with the legal provisions and clean the container 3 Close screw cap again and check proper seat of level sensors and connec tions 5 3 2 Disposable Tips 1 Disposable tips are automatically ejected at the tip ejection station Via a slide the
62. nore button Plate transport 1 motor not homed Plate transport motor cannot find home position Select the menu item Utilities Selftest to initialise the system again If the error persists call service Plate transport car rier error Plate holder does not move far enough into the instrument so that the light barrier is not interrupted Push the Retry button If the error recurs push the Ignore button If this error recurs the plate transport has to be adjusted new Call service Plate transport EEP ROM error EEPROM error in plate transport Call service Plate transport error Error in plate transport in case of increased resistance Push the Retry button If the error recurs try to locate the cause of the resistance blocking and eliminate it If no mechanical blockage is evident call service Plate transport sen sor error Error in plate transport sensor Call service Rack scanner focus ing error The barcode scanner of the reagent and sample racks cannot be focused Manual allocation of racks or samples and reagents is possible Call service Rack scanner motor error Motor error in scanner of reagent and sample rack Scanner firmware does not work correctly Electrical or mechanical problems of scanner Manual allocation of racks or samples and reagents is possible Call service Rack scanner not detected Scanner of reagent and sample
63. of the folder to dis play its contents in the right window Don t approve results without reviewing the original results printout and the events of the run 4 20 ELISYS QUATTRO User Manual HUMAN 4 5 1 Results Report 4 5 1 1 Laboratory Details Select the item Laboratory Details to open the window depicted to the right showing informa tion about the laboratory e g name address etc This information can be entered and edited via the menu items Utilities Options Labora tory 4 5 1 2 Title Block The Title Block identifies the assay respective assay definition file the results have been generated with It provides information on the plate ID and the person responsible for running the test specifies the assay used saves date and time the test has been finished and shows certain default settings of the photometric measurement such as the overflow limit and the wavelength as well as the reference wave length Furthermore important error messages that came up in the course of processing the assay respective the worklist are already displayed at this point 4 5 1 3 Reader The blank value is displayed in the Reader result section This section can also be used to show the raw data 4 5 1 4 Quantitative Results The window Quantitative Results shows the graph which is created with the standards defined in the assay ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 21 Performing a Test Run 4 5 1
64. on 3 Clean and disinfect waste container 6 1 3 Monthly Maintenance Procedure Where a disinfecting is required use always a non alcoholic type Do not use any disinfectants containing alcohol for Plexiglas surfaces and for the manifold e g cover Disinfectants must not come into contact with bearings and guides as other wise the greasy film may dissolve Disinfectants must not be used in the vicinity of circuit boards and light barri ers 1 Clean reagent and patient racks Clean all four washer buffer bottles with distillated water 3 Check the internal waste bottle 2 and empty it if necessary Clean the system liquid container with distillated water 4 Clean and disinfect the external waste container 5 Clean plate carriers Do not clean heated incubators 6 2 Service Plan to be performed by authorised Service Engineers Periodically during the year a specific preventive maintenance can be run by the au thorised technical personnel A specific procedure will be followed to ensure a good check on all the instrument parts which are Photometer Washer Incubator Plate transport ELISYS QUATTRO User Manual HUMAN Service and Maintenance Pipettor ELISYS QUATTRO User Manual HUMAN 6 3 Service and Maintenance 6 3 Cleaning and Disinfecting the Instrument Clean or disinfect the following instrument parts of the ELISYS QUATTRO in accord ance with the maintenance plan 1 Housing s
65. ons Please consider the following typographical conventions 1 1 1 Warning Messages Warning messages are indicated with a safety symbol and printed in special types For special situations the following security symbols were used Caution risk of danger Consult instructions for use Biohazard Electrical hazard Caution hot surface Mechanical hazard Automatic start up Laser hazard ELISYS QUATTRO User Manual HUMAN 1 1 Intended Use 1 1 2 Notes Notes are indicated with a symbol and printed in special types For special situations were used the following symbols Jil Consult instructions for use Notes are indicated by this symbol and printed in special types Disconnect mains power connector before servicing 1 1 3 Symbol Keys Manufactured by In Vitro Diagnostic Medical Device IVD Lot Number LOT EXP E Expiration Date Storage Temperature C CE Mark REF Catalogue Number SN Serial Number 1 1 4 Special Types LEDs LEDs light emitting diode are printed in spe cial type Example PWR LED ERR LED 1 2 ELISYS QUATTRO User Manual HUMAN Intended Use Menu items and fields Menu items and fields are printed in bold type Example File Menu Buttons Buttons are printed in spaced type Example Open button Keys Keys are printed in slanted type Example Press Enter 1 2 Safety Instructions CI Read all of these instructions Save these instructions f
66. or later use Please always act according to the following safety instructions before as well as during operation of the system The operating manual must be kept near the system and must be accessible for the user at any time ELISYS QUATTRO is a fully automated microplate analyzer including functions such as sample preparation test performance photometric measurement and data eval uation ELISYS QUATTRO is designed and manufactured in accordance with the safety re quirements for electronically and IVD measuring devices If the local law lays down regulations on the installation and or operation of microplate analyzers then it is the operators responsibility to adhere to them The manufacturer has done everything possible to guarantee that the equipment works safely both electrically and mechanically The systems are tested by the man ufacturer and supplied in a condition that allows safe and reliable operation The user has to observe the information and warnings contained in this operating manual in order to ensure safe operation of the instrument 1 2 1 General Safety Follow all warnings and instructions marked on the instrument and in this A manual The instrument must only be operated by personnel who have been trained on the use of the system It is strongly recommended that all first time personnel read this manual prior to use Use the system only for the designated application Use only the consumables and accessory
67. p Check filter posi tions Call service 43 43 A D conversion error Call service 43 46 nn Filter error nn shows the filter position Call service 43 48 nn Motor not homed nn shows the motor None The software will reset the pho tometer and try again 43 4C Lamp has blown Replace the lamp 43 4D nn Motor is jammed nn shows the motor Call service 43 50 Plate carrier error Check that the plate carrier correctly breaks the sensor Call service 43 50 44 No scan data available Call service 43 50 4F A D over range error Call service 43 50 55 A D under range error Call service 43 50 57 Reading overrun error Call service 43 52 A D reference voltage error Call service 43 54 nn Faulty optic channel nn shows the filter Call service position 43 57 EEPROM error Call service Table 7 4 Module 43 Photometer Module 44 Washer ELISYS QUATTRO User Manual HUMAN 7 7 Error Messages ME sit Cause Action 44 41 Argument error Call service 44 45 EEPROM error Call service 44 48 nn Motor not homed nn shows the motor None The software will reset the washer and try again 44 4D nn Motor has become jammed during Clear the obstruction Call service movement nn shows the motor 44 50 Plate carrier sensor error Call service 44 53 41 Washer waste bottle is full Empty the washer waste bottle Call service
68. regularly and have to be documented 6 3 3 Maintenance of Pipettor System The pipettor systems is automatically primed with system liquid during a run this process is controlled by the Phoenix software Further actions are also provided by daily and weekly maintenance 6 3 4 Maintenance of Washer System The washer system is automatically flushed with distilled water following each wash step this process is controlled by the Phoenix software The 4 containers with wash buffer distilled water and the complete washer unit in cluding manifold pumps valve tubing are cleaned during the daily and weekly maintenance ELISYS QUATTRO User Manual HUMAN 6 5 Service and Maintenance 6 4 Cleaning the Wash Head Needles The wash head could have had contact with dangerous material Pay at A tention to safety regulations Always wear gloves The wash head is part of the wash unit located in drawer 5 see figure 6 1 on page 6 4 If the wash function is not longer adequate you have to clean the needles of the wash head 1 Open drawer 2 Using the supplied cleaning needle clean the 8 dispense and the 8 aspirate needles of the wash head M Figure 6 2 Cleaning the wash head needles 6 6 ELISYS QUATTRO User Manual HUMAN Service and Maintenance 6 5 Replacement of Mains Fuse The mains fuse is on the back of the analyzer 1 Switch off the system A 2 Disconnect the system from the mains power 3 Pull out the
69. s the lot data entered before the start of the worklist the reagents used and the test kits 4 6 Re Loading To insert a new plate during a running worklist this can be done by re loading 1 Input of additional patient bar coded or non bar coded Bar coded patients First insert the bar coded patient samples and then assign the assays in the Patient Editor see chapter 4 2 2 on page 4 4 Processed sample racks red flashing LED may be removed Non bar codedNon bar coded patients First enter the additional patients in the Patient Editor see chapter 4 2 1 on page 4 2 2 Select the item Edit Panel Definition The Set up Panel dialog box appears show ing the current plate panel 3 Define additional plate panel via the Add Plate Add Assay andAdd Patient but tons see chapter 4 3 3 on page 4 8 4 After definition of the additional plate panel click on the OK button 5 Enter all Lot Specific Values see chapter 4 3 4 on page 4 8 After confirmation of the lot specific data the Load dialogue box appears possible during incubation phases or the system specifies that the system is currently busy The times for loading resources and plates are depicted in the worklist schedule When the specified time is over select the item Edit Panel Definition once more The Load dialogue box appears ELISYS QUATTRO User Manual HUMAN Performing a Test Run 4 23 Performing a Test Run 6 Patient samples Ins
70. sists call service Washer aspirate pump error Error in washer aspirate pump Confirm displayed message by pushing the Retry button If error recurs push the Ignore button Upon completion of the run or unlocking of the washer drawer check if the aspirate bottles are closed correctly If the error persists call service Washer dispense pump error Error in washer dispense pump Confirm displayed message by pushing the Retry button If error recurs push the Ignore button Select the menu item Utilities Selftest to initial ise the system again If the error per sists call service Washer EEPROM error Error in EEPROM of the washer module Call service Washer head home movement error Error when moving washer head to home position Select the menu item Utilities Selftest to initialise the system again If the error persists call service Washer head motor movement error Error in movement motor of the washer head Select the menu item Utilities Selftest to initialise the system again If the error persists call service Washer plate home movement error Error when moving to the home position Select the menu item Utilities Selftest to initialise the system again If the error persists call service Washer plate motor movement error Plate transport motor of washer blocked Select the menu item Utilities Selftest to initialise the system again If nec
71. step Click on the Open Panel button to open a stored plate panel Click on the Save Panel button to save the defined plate panel The assigned patients are not stored 3 Click on the Add Plate button Plate 1 is entered in the Explorer tree ELISYS QUATTRO User Manual HUMAN Performing a Test Run Set up Panel E Open Panel Add Patie Edit m 155950 8599000880 fee Ua lawl 2 Delete Undo Aledo rommonom m Start assay with a new strip dit Layout Save Panel Patient Details ok Cancel Set up Panel Plate 1 Open Panel Edit r Plate 1 DBS Zee ULL 2 Delete rommonom r Undo Bedo Start assay with a new strip dit Layout Save Panel Patient Details Cancel 4 5 Performing a Test Run Click on the Add Assay button The Open dialogue box shows all available assay files asy in the selected subdirectory Select the desired assay file Click on the Open button The plate panel pre defined in the selected assay protocol is entered into the plate depicted in the Set up Panel dialogue box except tests In the Explorer tree the
72. t the operating voltage is set correctly on all system components be fore you connect the system to the mains supply This product must be operated from the type of power source indicated on the type label If you are not sure of the type of power available consult an authorised sales person or your local electric power company Use a 3 wire grounding type plug to connect all instrument and peripherals to mains supply Use only extension cables with a protective conductor and grounded contact Grounding of the instrument computer and its peripheral devices to the same pro tective earth potential must be ensured Never knowingly interrupt the grounding contacts There is the risk of an electrical shock if the protective conductor is interrupted within or outside the device or has been disconnected The instrument must be connected with a delivered connection cable to dedi cated socket The use of a multi plug is not allowed Do not allow anything to rest on the power cord If you can see that the instrument has become unsafe to use switch it off and disconnect it from the mains supply ELISYS QUATTRO User Manual HUMAN Intended Use If liquid gets inside the instrument switch it off and disconnect it from the mains supply Clean and dry the respective parts Surfaces floors work table must be dry when you are working with the sys tem Only use the bottles tubing and components supplied and recommended for con
73. taining liquids on the instrument Spare fuses must match the values nominal voltage nominal current and A type specified by the manufacturer Always replace blown fuses don t try to repair them Never short circuit the fuse holder Switch the instrument off and disconnect it from the mains supply before serv icing Only when directed to do so should power be applied If power is applied while any covers are removed use extreme caution while servicing the system Never remove protective guards or secured components since you could ex pose live parts in this way Electrical connection contacts plugs sockets etc can be electrically live Even after the device has been switched off components e g capacitors can be under voltage as the result of an electrical charge All current carrying parts are sources of danger for an electrical shock Don t position the instrument so that it is difficult to operate the disconnecting device power supply switch mains power connector 1 2 3 Laser Safety Care must be taken when operating and testing the bar code scanners as they A use a laser class 2 Never look directly into the laser beam Output causes iritations of the eye if stared into the beam for long periods of time See for technical data of the laser bar code scanner For operating and testing the laser no optical devices may be used For operating and testing the laser watches and mirroring jewellery should
74. ter 1 Defect in heater foil no 1 Call service error Incubator sensor 1 Defect of incubator sensor no 1 Call service 7 2 ELISYS QUATTRO User Manual HUMAN Error Messages Error Cause Action No disposable tips left Pipettor tips used up or not found Reload required tips at the position indi cated on the monitor No fluid detected for 1 Insufficient volume for sample 1 or reagent 1 The status is documented in the active event log Confirm message with retry or ignore No further action is possible No respond to com mand 1 General software error Communica tion between PC and analyzer is interrupted Push the Retry button If the message comes up again push the Ignore but ton turn the PC off and start it again Answer the questions worklist and is the analyzer still running accordingly The system starts again and continues with the worklist in proc ess Plate ID verification error Plate bar code cannot be read Missing or faulty bar code incorrectly selected bar code type see scanner setup Enter the plate ID manually Plate transport 1 motor home error Plate transport motor cannot find home position Select the menu item Utilities Selftest to initialise the system again Plate transport 1 motor movement error Error in plate transport motor no 961 Push the Retry button If the error recurs push the Ig
75. type label in positioned on Rear side of the instrument near the mains switch 1 8 ELISYS QUATTRO User Manual HUMAN System Basics 2 System Basics 2 1 Overview The ELISYS QUATTRO is a fully automated microtiter plate analyzer performing the complete sample processing sample pre dilutions sample and reagent dispensing incubations wash processes plate transports as well as the photometric measure ment and evaluation The instrument is controlled via the Windows PC software Phoenix This software which was specifically designed for this purpose allows the user to process the pre defined assays as well as assays programmed by the user The clear structure with intuitive user guidance allows simple and quick operation of daily routine jobs as well as programming of user specific assays Figure 2 1 ELISYS QUATTRO Instrument modules Tray for tip racks and dilution tubes Patient sample and reagent rack unit with bar code scanner Tip eject station pipettor wash station pipetting station Test plate compartment plate transport unit Drawer with wash unit and photometer O oa A OQ N gt Position of incubators below test plates heated and for room temperature dark N Waste bag for tips Guide rail for pipettor X and Y movement 9 Pipettor movement in Z direction ELISYS QUATTRO User Manual HUMAN 2 1 System Basics 2 2 Top Level Instrument Modules
76. uld be loaded racks depicted in already available on the instrument tips may have been removed already pe The number of tips that are still available is taken into account by the software You can view the respective name of the dilution plate by moving the cursor over this plate mg Check if sufficient tips are available and if the tip size displayed agrees with the position on the instrument Please carefully check the tip racks allocation following the specific color code and type in the software A tip misplaced can not be recog nized by the instrument and may cause mechanical damage ELISYS QUATTRO User Manual HUMAN 4 15 Performing a Test Run 4 4 4 Reagent Volume Check After loading and allocation of all required resources press on the OK button A volume check of all rea DTITTERE8BUOO gents is carried out automatically Insufficient volume of CYTO IgM Pos Ctil If the reagent check shows that the volume of one position 12 4 for the Silence Alam reagent is low a System Error dialogue box appears alerting you about any insufficient volume To refill the respective reagent or to replace it by a new bottle the respective reagent rack has to be posue moved out reagent has to be refilled or the bottle replaced respectively and the rack has to be inserted again Ifyou press on the Refill Bottle button the volume is checked once more If the reagent was
77. um eee The panel of the first assay is hidden s 3 Select assay and patients as described in the eite steps before see chapter 4 3 1 page 4 5 eT Move Dowr H V Start assay with a new strip Edt Layout Archiving protocol DiaSoin z Dpen Panel Save Panel Patient Details OK Cance Help Set up Panel gd i m Add Plate Ae HDA puanda am TD 3 RUBE oG A Bi Add Patient 2 50 51 D 2 Delete E 3 F 4 Move Up G H S I Start assay with a new strip Edit Layout Open Panel _ Save Panel Patient Detail ok Caes Only possible with identical incubation parameters The item Start assay with a new strip must always be enabled ELISYS QUATTRO User Manual HUMAN 4 7 Performing a Test Run 4 3 3 Click on the Add Plate button Click on the Add Assay button and select an assay protocol see chapter 4 3 1 on page 4 5 3 Click on the Add Patient button and select patients The expanded Explorer tree is displayed along with plate 2 showing the panel of the active assay 4 Repeat this steps for further plates Na Further possibilities Click on the plus sign of an plate folder to view the respective assays in the Explorer tree Click on the plus sign of an assay folder to view the respective patient I
78. urface 2 Interior of instrument magazine for tip racks and dilution tubes 1 sample and reagent unit 2 test plate area 3 test plate compartment surface 4 incubators 6 drawer with wash unit and wash buffer 5 3 Manifold in washer unit 5 Disinfectants must not come into contact with bearings and guides as other wise the greasy film may dissolve Disinfectants must not be used in the vicinity of circuit boards and light barri ers Do not use any disinfectants containing alcohol for Plexiglas surfaces and for the manifold e g cover Figure 6 1 ELISYS QUATTRO Instrument modules ELISYS QUATTRO User Manual HUMAN Service and Maintenance 6 3 1 Cleaning and Disinfecting the Housing Surface Proceed as follows 1 Apply disinfectant on instrument housing surface 2 Let it take effect according to the manufacturer s specifications 3 Wipe instrument off with a cloth 6 3 2 Cleaning and Disinfecting the Interior of the Instrument If liquid got inside the drawers or individual modules turn the instru ment off immediately Clean the affected areas as quickly as possible using an appropriate cleaning agent take all sensitive parts and all parts that are relevant for operation into account guide rails door edg es plate transport unit drawers racks etc The actions listed in the maintenance schedule see chapter 6 1 on page 6 1 have to be performed
79. worklist Start Starts the loading dialogue once the loading dialogue has been completed a run using the current worklist can be started Stop Stops the current run The run can be contin ued again and one or several plates can be removed from processing Or the entire run can be aborted completely Load additional Allows the reloading of pipette tips tips View Module Schedule Graphical display of the processing of a work list module specific Plate Schedule Graphical display of the processing of a work list plate specific Utilities System Utilities Manual plate control Table 3 2 Worklist menu guidance 3 4 ELISYS QUATTRO User Manual HUMAN Software Structure and Operation 3 2 3 Result Menu Guidance Menu Item Icon Function Edit Outliers Shows the Outliers dialogue This dialogue shows all result values Changes of these val ues are marked in the result report Parameters Shows the Lot Specific Values dia logue This dialogue shows all data of the rea gents Changes of these datas are marked in the result report Assays Shows the Change Assay Protocol dialogue This dialogue shows the used assay Change of these assays are marked in the result report Retest Shows the Retest dialogue This dialogue shows all tested patients Select one or more patients you want to test it with these assays again Copy to clipboard Copy selected Quantitative Results to the windows clipboard
80. ws you all samples which were not pipetted or were a clot was detected The result file flags all samples with MP where a clot was detected ELISYS QUATTRO User Manual HUMAN 4 19 Performing a Test Run 4 4 7 Pausing or Cancelling a Run Click the Stop button to stop the current run The ELISYS QUATTRO system stops and shows System Paused xi the System Paused dialogue box Click Resume to continue the run Selecta plate and click Abort Plate s to remove the plate Click Abort Plates to remove all plates Any interruption of a run is documented with the time of its occurrence Help If an error occurs a run is automatically stopped A dialogue box with a message describing the error is displayed Error messages have to be confirmed accordingly and you may then continue or abort the run Plates Plate 1 5624524512 Abort Plate s Abort All Plates E R ELZN The ELISYS QUATTRO unloads an aborted plate at the next appropriate mo ment You must unload this plate otherwise the worklist will be paused An already started process step with another plate will be finished first 4 5 Results of a Run Upon complete processing of a plate the results are saved to a result file and displayed on the screen which can be printed in individual parts or as a whole Click on the plus sign in front of file name to open the folder tree of the result file Click on the individual symbol
81. y Control Analysis Report Levey Patient Result Report 1 la xj oj oe a oles gt Levey Jenning 21 303738 alue Mean 24 1 2 and 3 SD 13 4 1844 Wo 164 1a 14 T J 1 1 2 3 4 5 7 un Mean 1702 SD 0 186 SE 0 070 CV 10 93 Display help for clicked on buttons menus and windows NUM PIES dow Help 181 xi s u gt m w Patient Results Date range from 30 04 2003 to 30 04 2003 Signature Patient ID Patient name CYTO lgG CYTO laM RUBE IgG TOXO IgG 52320 52321 52322 52323 152324 152325 852324 0 094 Display help for clicked on buttons menus and windows 61 1 IU ml 61 6 IU ml 77 8 lU ml 77 8 lU ml 84 8 IU ml 106 01U ml 108 510 4 25 Performing a Test Run 6 Select the Sort Order 7 Click OK to confirm the entries The system shows you the patient result report 8 Select View Detail to show a detailed list including the Batch Number of the Kit if entered see chapter 4 3 4 on page 4 8 4 26 ELISYS QUATTRO User Manual HUMAN Loading Unloading Disposal 5 Loading Unloading Disposal 5 1 Loading Instrument at Hold 5 1 1 Refill System Liquid 1 Open screw cap of system liquid container and refill system liquid or replace container 2 Close screw cap again and watch for correct seat of level sensor and connec tions 5 1 2 Refi
82. y Help The different assay tabs must be selected by hand ELISYS QUATTRO User Manual HUMAN 4 4 4 4 1 When all dialogues have been processed as described above the Worklist window with the Worklist parameters and the Explorer tree appear The start time and end of the run as well as the plate status loaded not loaded error the selected assays and the number of patients are displayed In the Explorer tree click the plus sign of the work list folder and then the respective item Click on the Start button to start the worklist and open the Load dialogue see chapter 4 4 2 on page 4 12 4 4 1 1 Schedule The Schedule shows the process diagram for the worklist It can be presented as Module Sched ule see figure or as Plate Schedule The selection is made via the View menu The individual plates and process steps are dis played in different colors ELISYS QUATTRO User Manual HUMAN Performing a Test Run Start a Worklist The Worklist Window tis Phoenix Work 181 S Eile Edit View Utiities Window 18 xi gt Plate 10 Start Finish Status Assay Pationts Worklist parameters 3E schedue Plate 1 1438 16 58 Notloaded CYTO lgG 5 Plate layouts RUBE lgG 5 Qo Reagent requirements CJ System status Plate 2 1444 16 30
83. y go directly into the plastic waste container at the instrument front panel 5 3 3 Replace Waste Container for Disposable Tips 1 Pull cover plate next to the plate compartment out horizontally from the front Take waste container off the retaining ring and close it using the supplied lid 3 Place new waste container with plastic reinforcing onto the retaining ring and push it down 4 Attach cover plate again 5 Dispose off the closed waste container in accordance with the legal require ments Potentially infectious material and all parts that may come in contact A with potentially infectious material must be disposed off according to the legal requirements of the relevant country 5 3 4 Disposal of Instrument Disposal of the instrument according to national legislation 5 3 5 Disposal of Packaging Material Disposal of the packaging material according to national legislation ELISYS QUATTRO User Manual HUMAN 5 7 Loading Unloading Disposal 5 8 ELISYS QUATTRO User Manual HUMAN Service and Maintenance 6 Service and Maintenance The user must perform the maintenance work described in this chapter Any service work described in the service plan see chapter 6 2 on page 6 2 or not described in the user manual must be performed by authorised service engineers These maintenance procedures must be performed to keep the instrument in a prop er working condition Any deviations may lead to false results 6 1 Maintenance

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