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ELISA PLATE READER - DIAsource Immunoassays

1. 115 20 SAFETY CLEARANCE CERTIFICATE 116 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 5 of 117 1 GENERAL INFORMATION 1 1 Warranty Information Each Instrument is completely tested and guaranteed for twelve months from delivery The warranty applies to all the mechanical and electrical parts It is valid only for proper installation use and maintenance in compliance with the instructions given in this manual DIASOURCE IMMUNOASSAYS S A will at its discretion repair or replace parts which may be found defective in the warranty period The warranty does not include any responsibility for direct or indirect personal and material damages caused by improper use or maintenance of the instrument Parts that are inherently subject to deterioration are excluded from the warranty In case of defects due to misuse of the instrument any travel and man hour expenses will be charged extra 1 2 Technical Service DIASOURCE IMMUNOASSAYS S A is always accessible to the customers for any kind of information about installation use maintenance and others When asking for service please refer to this manual and report the data reported on the identification label serial number Only qualified technicians are entitled to repair i
2. 19 6 8 Micro Titer Plate Carriage 21 6 9 Plate Loading amp Pipetting Procedure 21 6 10 Readings Check 22 7 PRECAUTIONS 22 8 PROGRAMMING MODES 23 8 1 Absorbance Mode 23 8 2 Single Standard 26 8 3 Cut Off Mode 27 8 4 Reverse Cut Off Mode 43 8 5 Multi Standard Mode
3. 44 8 6 Percentage Absorbance 55 8 7 Uptake 55 8 8 Kinetic 56 9 RECALLING AND RUNNING OF STORED TEST PROGRAMS 57 9 1 Absorbance Mode 58 9 2 Cut off Mode 62 9 3 Multistandard 69 10 RERUNNING ACCEPTED TESTS PROGRAMS 81 11 SAMPLE AND SAMPLE DUPLICATE 85 12 PATIENT IDENTITY SAMPLE IDENTITY ENTRY 87 13 SAVE PLATE AND SAVE RESULTS
4. 7 3 INTRODUCTION 8 3 1 Description 8 3 2 Special Features 8 3 3 Technical Specification 9 4 PACKAGING TRANSPORT AND STORAGE 11 4 1 General Warnings 11 4 2 Packaging 11 4 3 Instrument Transportation 11 4 4 Storage of Instrument 11 5 INSTRUMENT DESCRIPTION 12 5 1 Instru
5. 90 14 VIEW STORED DATA 92 15 UTILITIES 94 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 4 of 117 15 1 Date amp Time Setting 95 15 2 Program Filter 95 15 3 Printer On Off setting 96 15 4 Enter Clinic Name 96 15 5 Shaker Plate Shaking Mode 97 15 6 Communication Settings 98 15 8 Install USB Driver 99 15 9 Auto Print O
6. 2 If you have selected Communication Setting ref 14 5 USB on instrument and you have selected a Serial communication on computer data receiving application you will get this message In such a case select USB communication on computer and select YES key to transfer data To avoid this message connect proper data cable select the same communication medium USB or Serial on computer data receiving application which you have selected on instrument Communication Setting 6 Filter Movement Error Instrument will display this message if there is problem with MOC sensor PCB or with filter tray stepper motor The MOC sensors are used to detect the position of filter tray These two sensors are mounted on bottom of the mechanism One detects the home position and second detects the each filter position of filter tray In such a condition we need to check the connection to these sensor and also the connection of stepper motor which is used to move filter tray 7 Plate Movement Error Instrument will display this message if there is problem with MOC sensor PCB or with plate carrier stepper motor The MOC sensors are used to detect the position of plate carrier These two sensors are mounted on top of the mechanism One detects the home position and second detects the each strip position of plate carrier In such a condition we need to check the connec
7. CAL 6 0 356 CAL 7 0 045 Numeric Value 2 250 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR CAL 1 2 562 ESC CAL 2 1 865 CAL 3 2 050 CAL 4 1 054 CAL 5 0 648 CAL 6 0 356 CAL 7 0 045 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 77 of 117 You can easily select any particular calibrator by touching that touch zone and edit the corresponding absorbance After editing the calibrator s absorbance select ESC A message will appear PLEASE WAIT and the modified graph will appear on the screen If calibrator s value being edited in Multistandard mode then Mod string is displayed in the print 9 4 Kinetic Select RUN to start to run the test in Kinetic mode Or else you can directly run the test from the List Test screen by selecting RUN option present on the screen KINETIC Name KIN_560 ESC Pri 560 Sec 0 EDIT Read Time 1 min RUN Read Period 15 sec PRINT Select Test ESC 1 HBSAg 2 HCVAb M RUN SEL 3 UPT 4 TSH 5 CPC C 6 PER_ABS P NEXT 7 CRP C 8 KIN_560 K PREV 9 SIN_630 S 10 CP_405 C DEL PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 78 of 117 The D M means delta per minute of reaction When test will over instrument will show you the D M values of reacti
8. MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial Communication UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 95 of 117 15 1 Date amp Time Setting This Utility helps the user to set current Date and Time 15 2 Program Filter It consists of two editable filters and thus helps the user to edit the filters if any Date DD MM YY ESC 01 01 08 Time Hrs Min Sec 12 30 10 XXX Numeric Value 250 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password Edit Filters YES NO XXX 250 YYY Numeric Value 400 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsse
9. S2 S10 Is Plate Removed YES NO Name HCV POS Cut Off Pri 560 Sec 0 ESC No Factor QC QCVal Mes Rem ACCEPT BL 1 Y 0 100 0 050 TEST NC 2 1 000 Y 0 150 0 098 PC 2 0 100 Y 0 500 2 658 PRINT LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS 0 563 Display VALUE QC1 2 560 QC2 QC3 QC4 LOAD NEXT Range 10 00 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 65 of 117 F DISPLAY VALUE option will display the result of all samples along with the controls selected G By selecting ACCEPT TEST option you can save this test with the details of controls absorbance Next time it is possible to run the same test without loading controls This means that the previous stored values of controls can be used All the details are in table format as per row and column shown on the screen You can obtain the print of the same format by selecting option PRINT RESULTS To check the results of next samples choose option NXT and then print it in format as shown on the screen by option Print Results You can obtain the print in matrix format by selecting option PRINT MATRIX In matrix form you will get the print as per your tray plate for all the wells Instrument prints seven different parameters in print matrix for a single well ROW IDENTIFICATION A B C D WELL NUMBER W1 W2 W3 W
10. option present on the screen It will print all the details of the test parameters alongwith QC equations A For running the test in CUTOFF mode select the particular test and point to RUN option present on the List Test screen Name HCV POS Cut Off Pri 560 Sec 0 ESC No Factor QC QCVal Mes EDIT BL 1 Y 0 100 0 000 RUN NC 2 1 000 Y 0 150 0 000 PRNT PC 2 1 000 Y 0 500 0 000 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 100 CUTABS 0 1 PC CF QC1 N Interpretation QC2 N Greyzone Y 10 00 QC3 N Cut off Index N QC4 N Range To change values press EDIT Name HCV POS Cut Off Pri 560 Sec 0 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B NC NC NC PC PC Select Test ESC 1 HBSAG M RUN SEL 2 TSH S PRNT 3 HCV C NXT 4 MUL_4P M PREV 5 CP_405 C DEL PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 63 of 117 B It shows the 12 strips horizontal with 8 wells vertical with blanks and controls loaded in first strip Select the No of Samples and enter the total Number of samples you want to load with the help of numeric screen displayed at the bottom of the screen C After entering No of samples select RUN The plate loading tray will come out and the following message will appear Is pla
11. 16 2 Send Test Records This option helps the user to send the Test Records created in one instrument to another instrument serially with the help of serial cable And therefore one has to select serial communication in Utilities Suppose by default if Serial Communication is set to USB then it will display following screen with msg string SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Send Test Records YES NO SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Invalid in USB communication UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 107 of 117 Instrument 1 16 3 Receive Test Records This option is used for receiving the Test Records from one instrument to another On selecting Receive Test Records it will display the string Download Test Records Yes No Select Yes in order to receive the data from the other instrument Note 1 User must first restart the instrument before sending the data from one instrument to another 2 Remember that while transferring Test Records from one instrument to another one must first select Receive Test Records and then select Send Test Records in order to send the data from one
12. CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 33 of 117 M After selecting No of PC s the screen below will appear on the display Enter number of Positive Controls by Selecting Zone No of PC s Maximum 5 Enter the QC value of the Positive Control by selecting the touch Zone Value of PC gt and enter the value of Y given in the reagent manual by selecting Zone Values Of Y N After entering the details of PCs escape from the screen by selecting ESC Below screen will appear on the display NOTE Same way you can enter values for LC lower positive controls and CC Cut of Controls Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 No of PC s 2 Values Of Y 1 000 Value of PC gt 0 500 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 34 of 117 Enter the Value for Cut Off F
13. ESC No of Samples 0 RUN DUP Y SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B NC NC NC PC PC Numeric Value 10 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR Name HCV POS Cut Off Pri 450 Sec 560 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B NC NC NC PC PC Name HCV POS Cut Off Pri 450 Sec 560 ESC No of Samples 10 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B S3 NC S4 NC S5 NC S6 PC S7 PC S8 S1 S9 S2 S10 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 87 of 117 Similarly user can load the samples and Sample Duplicates in all other modes 12 PATIENT IDENTITY SAMPLE IDENTITY ENTRY A To enter a patient ID for all samples there is option provided in loading screen shown as PID After entering number of samples either single or duplicate select PID Name HCV POS Cut Off Pri 450 Sec 560 ESC No of Samples 10 RUN DUP Y SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B S2 S6 S10 NC S2 S6 S10 NC S3 S7 NC S3 S7 PC S4 S8 PC S4 S8 S1 S5 S9 S1 S5 S9 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 88 of 117 A Individual PID entry One by one you can enter name of each patient The character length of PID is only 7 characters in the following combinations Since PID of the
14. In such case delete an individual control so that the average of remaining controls will satisfy the QC condition of that control as per reagent manual To select any control for deleting you must select the touch zone as shown in the above screen When you select any particular control for deleting suppose you have selected Negative Control NC HI or LO remark appear on the screen Select EDIT DEL key to proceed To delete the control select DEL After deleting that control the absorbance of that control will become zero and the average of controls will also get changed Select ESC option to come back to the Result screen Name HBSAG POS Cut Off Pri 560 Sec 0 ESC No Factor QC QCVal Meas Rem ACCEPT BL 1 Y 0 100 0 105 HI TEST NC 3 1 000 Y 0 150 0 200 HI PC 2 0 100 Y 0 500 0 456 LO PRINT LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS 0 563 DISPLAY VALUE QC1 2 560 HI QC2 QC3 QC4 LOAD Invalid Assay NEXT NOTE The absorbance of controls should not go above 3 50 If it is gt than 3 50 it will show the remark HI for that control In such a case edit the control absorbance UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 68 of 117 When you go back you will get the edited values for average of control with no remark for any control and
15. When the paper is almost finished red lines appear on both sides of the paper UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 19 of 117 6 6 Start up Instructions Switch on the instrument The instrument initializes all the parameters internally and carries out a power on self test During Initializing it displays the string Please wait system initializing It will display the ADDRESS screen after completing the initialization The instrument will print the model name ELISA READER VERSION NUMBER CLINIC NAME CURRENT DATE WITH TIME User can select a saved test by first touching the required Test Name on the screen and then touch the SEL option to carry out further operation on the test RUN option is used to directly run the selected test DEL Deletes the selected test If the numbers of tests are more than 10 NEXT and PREV options can be used for browsing through the list pages PRINT For printing the test screen MENU used to select Main menu screen PLATE DATA this option helps the user to view the Plate Results easily by selecting this option present on the screen ELISA READER DIASOURCE IMMUNOASSAYS S A Rue du Bosquet 2 B 1348 LOUVAIN LA NEUVE Tel 00 32 10 84 99 11 Fx 00 32 10 84 99 90 ELISA READER Date Clinic name VERSION Number MENU S
16. Where x is any channel number X 1 2 3 4 5 6 7 8 You can get this message in any mode of operation Before reading absorbance instrument is checking the filter reference voltages of all 8 channels If filter voltage of any channel is less than minimum required voltage it will display a message Check Light Path CH x Here x is channel numbers having reference voltage less than minimum required For ex If reference voltage of channel 3 is less the message will be displayed Check Light Path CH 3 It will indicate all channel numbers having less reference voltage like Check Light Path CH 1 3 6 In such a case there is a possibility of filter gain of that channel is reduced or intensity of lamp of that channel has become poor so contact factory engineer 3 Invalid Assay If in the Cut Off and Multi standard mode the controls and standards are not ok then this error message will appear 4 Memory Full If Number of saved tests exceeds the memory limit of 250 tests then delete the unwanted tests and save the test UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 114 of 117 5 Check USB Application on Computer Do you want to continue YES NO Using data receiving application on computer 1 If you have not connected the data cable USB or Serial correctly you will get this message
17. n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Duplicate Calibrator YES NO UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 50 of 117 H Graph type along with its scales There are three types of graphs in Multistandard They are mentioned as follows 1 Linear LINEAR 2 Point to Point PT TO PT 3 4 Parameters There are five types of scales for X and Y axis LOGABS vs CONC X axis Concentration v s Y axis LOG of ABS ABS vs LOGCONC X axis LOG of concentration v s Y axis Absorbance LOGITABS VS LOGCONC X axis LOG of concentration v s Y axis LOGIT of Absorbance ABS vs CONC X axis Concentration v s Y axis Absorbance LOGABS vs LOGCONC X axis LOG of concentration v s Y axis LOG of absorbance Selection of Graph Select Graph type as per the details given in the reagent manual by selecting Touch Zone Graph Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC UUsseerr M Maannuuaall EELLIISSAA P
18. 1 Send Results 2 Send Test Records 3 Receive Test Records Invalid in USB communication TECHNICAL DIAGNOSIS ESC 1 Clear Memory 2 Lamp Amplitude 3 Printer Selftest Clear Results YES NO TECHNICAL DIAGNOSIS ESC 1 Clear Memory 2 Lamp Amplitude 3 Printer Selftest Clear Test Records YES NO UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 110 of 117 When option Clear Memory is selected the instrument will first ask Clear Results YES NO If YES is selected it will only clear saved patient results and saved plates stored in the memory and shows message Clearing Memory This option does not clear the programmed test saved in instrument memory After clearing the memory or if option NO is selected the next question appears 17 2 Lamp Amplitude This option is used to check the light gain of filters used in the instrument There are 8 channels used of same type This option shows the gain of each channel filter in table format In the instrument the range of amplitude is from 600 00 to 2450 00 If the amplitude goes below 600 00 for any channel the message Amp Low will appear on the screen for that particular channel if the amplitude goes more than 2490 00 than the over range saturation voltage figure of 2500 00 will be passed The gains of filters are set within a required range When yo
19. 2042 6 2014 7 CH5 CH6 CH7 CH8 1904 8 2007 7 1891 1 1935 2 1904 7 2007 7 1891 1 1934 9 1904 9 2007 7 1891 2 1935 0 1905 1 2007 9 1891 3 1934 9 Displays the Lamp amplitude of a single selected filter UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 112 of 117 17 3 Printer Self test It is used to check the printing of thermal printer Is it printing perfectly or not When you select this it will print first two lines of Technical Diagnosis Screen 17 4 Lamp Centering Check NOTE Lamp Centering Check is not for users Do not select this option and don t change any settings otherwise the mechanical alignment will get disturbed since it is for factory use only UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 113 of 117 18 Trouble Shooting CAUSE CORRECTIVE ACTION 1 Printer disabled Disable Printer YES NO You will get this message if paper is not loaded properly or lever is not at correct position Check all possibilities Also check ON LINE and FEED LED glowing or not and when you switch ON the instrument check paper is moving forward or not If LEDs are not glowing and paper is not moving forward contact service engineer 2 Check Light Path CH x
20. 3 LOGIN 4 LOGOUT USER TANIYA A B C D E F G H I J K L M N O P ENTER Q R S T U V W X CLR Y Z _ 1 2 3 4 5 6 7 8 9 0 To Login enable user enter the USER name and select ENTER Password Utility 1 Enable Disable ESC 2 Set Password 3 LOGIN 4 LOGOUT Password Utility 1 Enable Disable ESC 2 Set Password 3 LOGIN 4 LOGOUT Logout To Logout disable user select LOGOUT option present on the screen UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 103 of 117 16 SERIAL COMMUNICATION The instrument is equipped with an RS232 serial port for PC configuration ie User computer interface A cable a NULL MODEM cable is required not provided to link the instrument to PC Communication will only start when both ends detect the presence of an active terminal or device RS232 port settings in a windows Operating system There is an option present on the Main menu screen named as SERIAL Communication which is used for transferring data from instrument to the computer and also from instrument to instrument PORT SETTINGS Bits per second 9600 Data Bits 8 Parity None None Stop Bits 1 Flow control None MAIN MENU ESC 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial communications UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAA
21. 85 Protect the instrument from direct sunshine 6 3 Power Supply Requirements Plug the instrument into a power source by the locally available approved plug in cable Power cord should be CE CSA and UL marked 115 230 Volt 10 50 60 Hz 6 4 Protective Grounding Please make sure that electrical power source is properly grounded 6 5 Printer ELISA READER Analyser is equipped with a built in 52 columns easy load thermal printer Procedure to load the paper is as follows Opening the Paper Cover Slide the LEVER towards back of the printer to open lock of the Paper Cover Lightly push up on the front of the paper cover marked with your thumb and rotate it towards the back of the printer UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 18 of 117 Closing the Paper Cover replacement of paper roller Close the paper cover and push down till you get locking sound Open the paper cover Remove the paper roller from the slot and place the paper roll over it as shown Place back the paper roller with paper into the slot provided and close the paper cover as described before Keep pressing the paper feed switch until the paper feeds straight and smoothly HINT When the paper is set correctly and when the closing of the paper cover is proper the FEED LED will not glow It keeps on flashing when the data is being printed
22. CUTABS NC PC CF QC1 gt Y 0 500 Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 Cut off Index is the ratio of Sample Absorbance Cut off Absorbance When you select Cutoff Index Y the Greyzone will become NO means inactive In Cutoff Index provide the range for interpretation the positive and negative value of ratio Sample Abs Cutoff Abs In case of Cutoff Index Range It gives the Positive remarks to sample having index value a ratio of Sample abs Cutoff Abs greater than or equal to entered POSITIVE value and it gives Negative remarks to sample having index value a ratio of Sample abs Cutoff Abs less than entered NEGATIVE value The sample having index value in between POSITIVE and NEGATIVE range get remarks Equivocal EQ RESULT RANGE ESC POSITIVE gt 1 000 NEGATIVE lt 0 000 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 42 of 117 After entering the Interpretation values ie conditions for interpretation the screen will be displayed as follows S To save the test after entering all the parameters select SAVE option Name HBSAG POS Cut
23. EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 117 of 117 b Other Biohazard YES NO If YES Please specify
24. Factor Z Abs any absolute value CF Cut off Factor ALg Anti LOG Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 CUTABS ESC CUT ABS NC PC CF NC PC LC CC CF ENTER CLEAR 1 2 3 4 5 6 7 8 9 0 Sqrt Lg ALg Ln ALn Abs CUTABS ESC UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 36 of 117 For Example For equation CUT OFF ABS 0 45 NC 0 35 PC 0 10 the formula can be entered in two ways 1 Enter the values as it is i e CUTABS 0 45 NC 0 35 PC 0 010 Keep the multiplication factors X Y W Z of controls NC PC CC and LC a constant number 01 Numbers mathematical functions and symbols for NC PC CC LPC can be selected from the screen OR 2 In second method the formula can be entered as CUT ABS NC PC CF Since the Value of X Y Z W is entered in the QC option of NC PC CC LPC and Cut off factor in the CUT FAC option there is no need to enter the same data again Means here Multiplication Factor for NC X 0 45 Multiplication factor for PC Y 0 35 and t
25. Off Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS NC PC CF QC1 gt Y 0 500 Interpretation QC2 N Greyzone Y 10 00 QC3 N Cut off Index N QC4 N Range Name HBSAG POS CutOff Pri 405 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS NC PC CF QC1 gt Y 0 500 Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 1 000 Neg 0 900 For example If you enter POS gt 1 0 and NEG lt 0 9 Then the sample will get POSITIVE remarks having INDEX Value Sam Abs Cutoff Abs gt 1 000 The sample will get NEGATIVE remarks having INDEX Value Sam Abs Cutoff Abs lt 0 900 The sample will get EQUIVOCAL remarks having INDEX Value Sam Abs Cutoff Abs in the range from 0 900 to 1 000 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 43 of 117 8 4 Reverse Cut Off Mode For Reverse Cut Off mode select touch zone POS Cut off key It will change to REV Cut Off In Reverse Cut Off Mode programming of test is the same as Positive Cut off Mode Only QC check conditions
26. Patient is entered with the help of Alpha numeric characters the combination must be as mentioned below For example 1 In the first combination user can enter PID with 4 Alphabets and 3 Numbers That means entered PID should be PQRS123 2 Similarly for the second combination user can enter PID with 3 Alphabets and 4 Numbers And therefore entered PID will be UTV1234 3 And for the third combination user can enter PID with 2 Alphabets and 5 Numbers ie PID will be displayed as RB12345 Alphabets Numbers 4 3 3 4 2 5 Name HCV POS Cut Off Pri 450 Sec 560 ESC No of Samples 10 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B S3 NC S4 NC S5 NC S6 PC S7 PC S8 S1 S9 S2 S10 Sample PID ESC 1 PRST123 2 3 4 5 6 7 NEXT 8 9 PREV 10 SEQL PRST123 A B C D E F G H I J K L M N O P ENTER Q R S T U V W X CLEAR Y Z _ 1 2 3 4 5 6 7 8 9 0 Sample PID ESC 1 PRST123 2 3 4 5 6 7 NEXT 8 9 PREV 10 SEQL UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 89 of 117 Enter Initial Alphabets Maximum 4 characters Enter Initial Well Number This is the starting well location of any particular batch Enter last Well Number This is the last well location of any particular batch Enter Initial PID Number This is the starting number of any particular batch 4 But o
27. Precisely through the stepper motor Printer Built in Thermal Printer 52 columns Memory Battery backup supporting 2500 open channels 64 KB Non Volatile RAM Analysis Mode Absorbance Single Standard Cut off Multi Standard Absorbance Uptake Kinetic Connectivity RS232 Serial Port USB 9600 baud 8 data 1 stop no parity bits USB Power Wattage Voltage 75 Watts 115 230 Volt 10 50 60 hz Operation Position On horizontal flat rigid and vibration free surface Operating Conditions Temperature Relative Humidity From 18 C to 35 C Up to 80 Storage Conditions Temperature Relative Humidity From 10 C to 40 C Up to 80 Enclosure ABS Fire Retardant Size cm 36 x 36 x 22 lxbxh Weight Approx 10 Kgs UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 11 of 117 4 PACKAGING TRANSPORT AND STORAGE 4 1 General Warnings Instrument has to be decontaminated before packing for transportation 4 2 Packaging Packaging is needed whenever the instrument is to be transported or shipped by courier or other purposes To pack the instrument the following instructions has to be followed 1 Decontaminate the instrument as explained on decontamination chapter of this manual 2 Put the instrument into the original packaging box Instrument has to be properly protected by plastic protective materi
28. QC value of the Negative Control by selecting the touch Zone Value of NC and enter the value of X given in the reagent manual by selecting Zone Values Of X Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 0 1 000 Y PC 0 1 000 Y LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 No of NC s 3 Values Of X 1 000 Value of NC lt 0 150 Numeric Value 1 2 3 4 5 6 ENTER UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 32 of 117 K After the entry of N of NC s Select ESC The below screen will appear on the display L Entry of Positive Controls PC Select touch Zone PC Name HBSAG POS CutOff Pri 450 Sec 630 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 0 1 000 Y LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 0 1 000 Y LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000
29. activates it Name POS CutOff Pri 405 Sec 0 ESC EDIT No Factor QC QCVal Mes Rem RUN BL 0 N NC 0 1 000 N PC 0 1 000 N LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 21 of 117 6 8 Micro Titer Plate Carriage The instrument is provided with a micro titer plate carriage to move the micro titer plate inside This carriage is driven by stepper motor with timing belt It places each well of plate exactly below the optical path of each channel The plate carrier is moved by a well controlled stepper motor drive 6 9 Plate Loading amp Pipetting Procedure Control and sample pipetting procedure in case of cut off Maximum number of Blanks 5 Maximum number of Controls 1 Negative Control 05 2 Positive Control 05 3 Cut of control 05 4 Low Positive Control 05 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 22 of 117 Pipetting sequence should be as shown below 6 10 Readings Check Checking of readings should be done through controls reading within range specified in data sheet of controls care should be taken while preparing and pipetting controls
30. be saved Name TSH MULTI STANDARD ESC Pri 450 Sec 0 BL Y CAL 7 Range High gt 16 61 Low lt 10 30 NXT HI CO High gt Low lt LO CO High gt Low lt PREV NO SAMP ABS AVG CONC REM PID A1 B 0 050 0 050 SAVE B1 C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS 1 SAVE PLATE DATA ESC 2 SEND PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 92 of 117 14 VIEW STORED DATA The stored plate or stored results appear on the screen by selecting option View Plate in MAIN MENU 14 1 PLATE RESULT It displays the details of stored plate last 10 plates with date test name and mode of operation in descending order User can select any test to view its plate results by selecting this option Print Matrix will print the details of entire plate in matrix format as explained earlier Print will print only the data displayed on screen Send data can be used to send the data from instrument to computer through USB or serial RS232 connection MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial Communication 1 PLATE RESULTS ESC 2 PATIENT RESULTS 1 PLATE RESULTS ESC 2 PATIENT RESULTS NO DATE TEST MODE ESC 4
31. for blanks and controls get reversed In the INTERPRETATION sample absorbance which is lesser than cut off absorbance gets remarked POSITIVE Sample absorbance higher than cut off absorbance gets remarked NEGATIVE This is exactly the opposite to normal POSITIVE Cut Off Mode Same way in case you select Cutoff Index Range Name REV CutOff Pri 450 Sec 0 ESC No Factor QC QCVal Mes Rem SAVE BL 0 N NC 0 1 000 N PC 0 1 000 N LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone Y 10 00 QC3 N Cut off Index N QC4 N Range UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 44 of 117 8 5 Multi Standard Mode In this mode the instrument accepts a maximum of 12 calibrators and calculates concentration based on the best fit curve Graph is printed with Absorbance on Y axis and concentration on X axis Programming a New Test A Select Main Menu Test Operation Add New Test B Select Touch Zone Multi Standard After selecting Multistandard mode it will display following screen Name MULTISTANDARD Pri 405 Sec 0 BL N CAL 2 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC Select Test Mode ESC 1 gt A
32. no Invalid Assay message NOTE Make the blank absorbance valid in case the absorbance doesn t meet the QC conditions If necessary valid the control absorbance because the absorbance of the blank affect the absorbance of all controls and samples It is recommended that for a test with single blank and single control if absorbance doesn t satisfy QC conditions or if all controls of any single type means all NC controls or all PC controls doesn t meet the QC the test will become totally invalid It is not possible to make the VALID TEST and new controls have to be loaded NC VALUE 0 200 ESC NC1 0 150 DEL NC2 0 350 HI NC3 0 200 HI UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 69 of 117 9 3 Multistandard After recalling the test in multistandard mode it will display following screen Take the print of the test parameters if required and select Run option Or else you can directly run the test from the List Test screen Multi Standard Mode A For running the test in MUL_STD mode select the particular test and point to RUN option present on the screen On selecting RUN option it will display following screen Name TSH MULTISTANDARD ESC Pri 450 Sec 560 No of samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B C1 C2 C3 C4 C5 C6 C7 HI CO 0
33. results one after the other NOTE 1 When there is not enough memory the following message appears Memory Left for samples First Samples Deleted The instrument automatically deletes a number of samples that are stored in the beginning 01 01 08 Test M Result PID Remarks MUL_4P M 10 48 VSR1 EQ MUL_4P M 12 63 VSR2 POS MUL_4P M 7 450 VSR3 NEG MUL_4P M 13 80 VSR4 POS SIN405 S 267 7 NRA1 EQ SIN405 S 220 3 NRA2 NEG SIN405 S 180 2 NRA3 NEG SIN405 S 326 7 NRA4 POS ESC NEXT PREV PRINT 1 PLATE RESULTS ESC 2 PATIENT RESULTS Select Test ESC 1 HBSAg 2 HCVAb M RUN SEL 3 UPT 4 TSH 5 CPC C 6 PER_ABS P NEXT 7 CRP C 8 KIN_405 K PREV 9 SIN_630 S 10 CP_560 C DEL PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 94 of 117 and then save the new samples at that location 2 If a test is being deleted or edited then previously stored results of that particular test are displayed with their test mode as X But test name retained as it is 15 UTILITIES UTILITIES consists of 11 different functions which can be viewed as follows 01 01 08 Test M Result PID Remarks MUL_4P X 10 48 VSR1 EQ MUL_4P X 12 63 VSR2 POS MUL_4P X 7 450 VSR3 NEG MUL_4P X 13 80 VSR4 POS SIN405 S 267 7 NRA1 EQ SIN405 S 220 3 NRA2 NEG SIN405 S 180 2 NRA3 NEG SIN405 S 326 7 NRA4 POS ESC NEXT PREV PRINT
34. sample B W1 W2 W3 W4 W5 W6 0 300 0 100 1 200 0 200 2 600 0 800 0 015 0 028 0 037 0 050 0 034 0 045 0 030 0 056 0 075 0 100 0 068 0 090 On selecting SEND PLATE option user can send the plate data to computer with the help of USB or SERIAL communication LOAD NEXT is used to load the next plate UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 80 of 117 Example Print out obtained from ELISA READER Note Same Procedure can be used to create and run the test in all other modes like Single Standard Absorbance amp Uptake UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 81 of 117 10 RERUNNING ACCEPTED TESTS PROGRAMS ACCEPT TEST option is used to store the data of controls or calibrators After running any test first time with controls or calibrators you select option Accept Test to save the data of controls or calibrators so that next time when you want to load the same test there is no need to load controls or calibrators in ELISA plate You can use previously stored data A In CUT OFF Mode B In Multi standard Mode Name HCV POS Cut Off Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem ACCEPT BL 1 Y 0 100 0 050 TEST NC 3 1 000 Y 0 150 0 098 PC 2 0 100 Y 0 500 2 658 PR
35. select ACCEPT TEST option to save graph whenever you run the test with calibrators Origin at X 0 000 y 0 000 X div 2 500 y div 0 150 ESC 3 000 PRINT EDIT 2 000 1 000 0 001 0 000 10 00 20 00 40 00 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 76 of 117 9 3 A Invalid assay in Multi standard Mode In Multi standard the absorbance of calibrators should be in increasing or decreasing from one calibrator to the next calibrator If any calibrator s behave s incorrectly you will obtain a message Invalid Assay at bottom side of screen If Assay is Invalid then Accept Test Save Results Print Matrix Save Plate options are blocked In such a case select VIEW GRAPH option and change the ASSAY to VALID with the help of EDIT option present on the Graph screen Name TSH MULTI STANDARD ESC Pri 450 Sec 630 BL Y CAL 7 Range High gt 16 61 Low lt 10 30 NXT HI CO High gt Low lt 0 000 LO CO High gt Low lt PREV NO SAMP ABS AVG CONC REM PID A1 B 0 050 0 050 SAVE B1 C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 Invalid Assay LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS CAL1 2 562 CAL 2 2 259 CAL 3 2 050 CAL 4 1 054 CAL 5 0 648
36. so that you can run only samples to get their results without loading Blank and Controls If you want to load only Blank select Load Blank YES and Load Controls NO In case if you are using previously Stored Blank and Controls then it will print following strings in the printout Using Blank Stored value and Using Controls Stored value UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 83 of 117 C In Multi Standard Single Standard Absorbance Uptake Mode In Calibrator Mode after asking Load Blank Yes No you will get the following question Load Calibrators Yes No If you are loading new calibrators and want the results of samples as per new graph select Load Calibrators YES Or else If you are not loading new calibrators and want to use previously stored graph select Load Calibrators No If you want to load only Blank select Load Blank YES and Load Calibrators NO In case if you are using previously Stored Blank and Calibrators then it will print following strings in the printout Using Blank Stored value and Using Calibrator Stored value Name TSH MULTI STANDARD Pri 560 Sec 0 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 Load Blank YES NO Name TSH MULTI S
37. 02 01 12 SIN_405 S 3 01 01 12 TSH M SEL 2 30 12 11 HBSAG C 1 28 12 11 CPC C 4 02 01 12 SIN_405 S Press Select key ot proceed SIN_405 02 01 12 NO SAMP ABS AVG RES REM PID A1 C1 0 083 0 083 50 00 B1 S1 0 544 0 544 326 7 POS VSP 1 C1 S2 0 367 0 367 220 3 NEG VSP 2 D1 S3 0 538 0 538 322 9 POS VSP 3 E1 S4 0 300 0 300 180 2 NEG VSP 4 F1 S5 0 700 0 700 420 0 POS VSP 5 G2 S14 0 326 0 326 195 6 NEG VSP 14 H2 S15 0 491 0 491 294 7 EQ VSP 15 ESC NEXT PREV PRINTMATRIX SENDDATA PRINT UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 93 of 117 Note User can directly view the details of Plate Results by accessing it through Plate Data option present on the Select Test screen 14 3 PATIENT RESULTS It will show the details of all samples saved in memory using option SAVE RESULTS in all different modes as explain earlier This option will display the data in table format as shown below Test name Mode of test operation result of sample PID and Remark will appear on the screen The instrument has a memory to store 2500 sample results This option doesn t show the information of controls or calibrators PRINT is used to print the details as available on the screen NEXT and PREV options are used to browse through the pages so that one can view all the
38. 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 54 of 117 J Normal Range selection for interpretation of samples For interpretation of specimen result POSITIVE or NEGATIVE enter normal range given in REAGENT MANUAL Select Interpretation N It will change to Interpretation Y Then select HIGH gt and LOW lt to enter normal range Enter Normal Range for positive and negative samples After entering all the parameters save the test by selecting SAVE option All the results whose concentration is coming above the High Range will be considered as positive and coming below the Low Range will be consider as negative The results having concentration in between High and Low range will get remarks Equivocal EQ Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y SAVE HI CO Y High gt 25 03 Low lt 10 54 LO CO Y High gt 16 61 Low lt 5 45 Interpret n Y Range High gt 0 000 Low lt 0 000 Graph 4 PARAMETER Y vs X ABS vs CONC Enter HIGH Range value High gt 0 000 ESC Low lt 0 000 Enter HIGH Range value High gt 15 25 ESC Low lt 9 46 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Ver
39. 4 WELL ID OR SAMPLE NUMBER BL NC PC OR S1 S2 S3 PATIENT IDENTIFICATION RAMESH VIKAS etc WELL ABSORBANCE 0 050 0 098 0 085 SAMPLE CONCENTRATION 0 738 0 689 2 578 INTERPRETATION REMARKS POS or NEG or EQ Name HCV POS Cut Off ESC Pri 560 Sec 0 BL Y Range PERCENTAGE 10 00 NXT Pos 0 330 CUT ABS 0 300 Neg 0 270 PREV NO SAMP ABS AVG INDEX REM PID A1 B 0 050 0 050 B1 NC G1 S1 0 200 0 200 0 254 NEG PQR 1 H1 S2 1 854 1 854 7 245 POS PQR 2 PRINT SAVE PRINT PLATE RESULTS RESULTS MATRIX OPT UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 66 of 117 Example Print out of POS CUTOFF test obtained from ELISA Reader UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 67 of 117 9 2 A Invalid Assay in Cut Off Mode If any individual control behaves incorrectly and it s absorbance is not satisfying the QC check value of that control the following message appears Invalid Assay and a remark HI or LO for that particular control OR if the QC1 QC2 QC3 and QC4 which has an other QC condition of controls like some reagent manual gives condition PC NC gt 0 2 or NC PC gt 0 5 the following message appears Invalid Assay and a remark either HI or LO for that QC condition
40. AATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 56 of 117 Read Time is total read period of the whole test You need to enter it only in minutes Read Period is time interval between two readings User must enter it in seconds Sample Absorbance Please refer 8 5 for parameter entry 8 8 Kinetic After entering Test Name and Filter values select Read Time and Read Period Name UPTAKE Pri 405 Sec 0 BL N CAL 1 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt KINETIC Name KIN_560 ESC Pri 560 Sec 0 SAVE Read Time 1 min Read Period 15 sec KINETIC Name KIN_560 ESC Pri 560 Sec 0 SAVE Read Time 1 min Read Period 15 sec Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR KINETIC Name KIN_560 ESC Pri 560 Sec 0 SAVE Read Time 1 min Read Period 15 sec Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 57 of 117 Finally select the Save option in order to save the test in KINETIC mode 9 RECALLING AND RUNNING OF STORED TEST PROGRAMS Test can be recalled by Name Mode Number or by List test The entire saved tests are available on the List Test or on the first screen after initialization User can direc
41. DDEERR Version 150511 PI number 1701327 Page 104 of 117 16 1 Send Results SEND RESULTS helps the user to transfer all the Results stored in the instrument to the computer via Serial Communication Results can be send either through USB or SERIAL communication Before Sending the Results A driver and the corresponding Data Transfer application must be downloaded on your computer Further information can be requested to our distributor or to our technical support Department IVDInstrumentation support diasource be check whether the Serial cable USB cable is connected to both the ends of the instrument and the computer respectively MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial communications SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Send Results YES NO SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Sending UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 105 of 117 These Results are send through Application and the Excel file is created as shown below UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 106 of 117
42. DEERR Version 150511 PI number 1701327 Page 71 of 117 D You can locate Controls from first well or after last calibrator to last well of strip 12 in any test Suppose you select column 2 amp row A for first HI control and column 2 row B for second HI control then the location of HI control will be display on screen as shown below E Select No of samples you want to run In case of 10 samples it will load 10 samples as follows Name TSH MULTISTANDARD Pri 450 Sec 560 ESC No of samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B HC C1 HC C2 C3 C4 C5 C6 C7 HI CO 2 COL ROW Name TSH MULTISTANDARD Pri 450 Sec 560 ESC No of samples 10 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B HC S5 C1 HC S6 C2 LC S7 C3 LC S8 C4 S1 S9 C5 S2 S10 C6 S3 C7 S4 HI CO 2 LO CO 2 COL COL ROW ROW UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 72 of 117 F Now Select RUN option so that readings can be taken in MULTI STANDARD mode The plate holder will come out and will display the message string Is Plate loaded YES NO The plate has to be loaded in such a way that the direction of the calibrators should go in first and then select YES The instrument will read the absorbance of calibrators and samples And finally display the string Is plate removed YES NO Remo
43. F G H I J K L M N O P ENTER Q R S T U V W X CLEAR Y Z _ 1 2 3 4 5 6 7 8 9 0 Name POS CutOff Pri 450 Sec 0 ESC No Factor QC QCVal Mes Rem SAVE BL 0 N NC 0 1 000 N PC 0 1 000 N LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 29 of 117 Select the required filters either Monochromatic or Bichomatic by selecting the filter values from Select Filter Val region D Selection of Primary and secondary filters Select zone Pri on the touch screen E According to the reagent manual change Blank NCs PCs to YES for QC check Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 0 N NC 0 1 000 N PC 0 1 000 N LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 Name HBSAG POS CutOff Pri 405 Sec 0 ESC No Factor QC QCVal Mes Rem SAVE BL 0 N NC 0 1 000 N PC 0 1 000 N LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y
44. INT LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS 0 563 Display VALUE QC1 2 560 QC2 QC3 QC4 LOAD NEXT Name TSH MULTI STANDARD ESC Pri 450 Sec 560 BL Y CAL 7 Range High gt 16 61 Low lt 10 30 NXT HI CO High gt Low lt 0 000 LO CO High gt Low lt PREV NO SAMP ABS AVG CONC REM PID A1 B 0 050 0 050 SAVE B1 C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 G1 S1 0 200 0 200 2 100 NEG TSH 1 H1 S2 1 854 1 854 9 845 POS TSH 2 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 82 of 117 When you want to run such an accepted test select RUN option in test detail screen in CUT OFF mode Name HCV POS Cut Off Pri 450 Sec 560 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 Load Blank YES NO Name HBSAG POS Cut Off Pri 450 Sec 630 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 Load Controls YES NO This time the blank and controls will not be loaded directly and you will get the following questions Load Blank YES NO and Load Controls YES NO If you are running both select YES and if you want to use earlier stored data of controls select NO
45. J K L M N O P ENTER Q R S T U V W X CLEAR Y Z _ 1 2 3 4 5 6 7 8 9 0 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 25 of 117 5 Select primary and secondary filter E Select primary and secondary filter F If blank is required select BL G In absorbance mode there are two modes of operations Normal Absorbance Mode Instrument gives the absorbance of each and every well Select touch zone NORM Differential Absorbance Mode Instrument shows the difference of absorbance between odd number wells and even number wells For Example Strip 1 Strip 2 Strip 3 Strip 4 Strip 5 Strip 6 For this Mode select touch zone DIFF In Normal Mode In Differential Mode NORM ABSORBANCE Name ABS560 BL Y ESC Pri 405 Sec 0 NORM MODE DIFF If you select BL Y it will read first well first strip A1 as a blank and subtract the absorbance of blank well from all other well s absorbance NORM ABSORBANCE Name ABS560 BL N ESC Pri 405 Sec 0 NORM MODE DIFF Pri 560 ESC Sec 0 Select Filter Val 0 405 450 492 630 NA NA 560 YYY NORM ABSORBANCE Name BL N ESC Pri 405 Sec 0 SAVE NORM MODE DIFF DIFF ABSORBANCE Name ESC Pri 405 Sec 0 SAVE NORM MODE DIFF UUsseerr M Maannuuaall EELLIIS
46. LO CO 0 COL COL ROW ROW Name TSH MULTISTANDARD Pri 450 Sec 560 BL Y 0 000 CAL 7 ESC DUP Y DUP Y EDIT RUN HI CO Y High gt 25 03 Low lt 10 54 PRINT LO CO Y High gt 16 61 Low lt 5 45 Interpret n Y Range High gt 15 25 Low lt 9 46 Graph 4 PARAMETER Y vs X ABS vs CONC To change values press EDIT Select Test ESC 1 HBSAg 2 HCVAb M RUN SEL 3 UPT 4 TSH 5 CPC C 6 PER_ABS P NEXT 7 CRP C 8 KIN_560 K PREV 9 SIN_630 S 10 CP_405 C DEL PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 70 of 117 B To enter total No of HI controls select HI CO option and enter numeric value C If you select No of HI controls 2 then you have to locate the position of HI controls by selecting column number and row number For column number entry select COL option and enter column number For row entry select ROW option and enter row position Similarly you can enter No of LO Controls and locate its positions Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR HI CO 2 ROW COL 2 3 Please Enter Col Entry 1 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR HI CO 2 ROW COL A 2 B 3 Please Enter Row Entry 1 Row Entry A B C D E F G H ENTER CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAAD
47. N 99 15 10 PASSWORD 100 16 SERIAL COMMUNICATION 103 17 1 Clear Memory 109 17 2 Lamp Amplitude 110 17 3 Printer Self test 112 19 DECONTAMINATION 115 19 1 Decontamination Procedure 115 19 2 Purpose of Decontamination 115 19 3 General Considerations 115 19 4 Procedure
48. PLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 51 of 117 1 Linear mode graph type After Selecting the Graph follow screen will come on the display Select Graph type as Linear Select scale as per the details given in the reagent manual 2 Point to Point Graph Type Select touch zone PT to PT abs scale of graph ABS vs CONC 3 4 Parameters Graph Type Select touch zone 4 Parameters amp abs scale of graph as ABS vs CONC Remember that it s default scale type is ABS vs CONC Graph LINEAR ESC Y vs X ABS vs CONC TYPE SCALE LINEAR LOGABS vs CONC ABS vs LOGCONC PT TO PT LOGITABS vs LOGCONC ABS vs CONC 4 PARAMETER LOGABS vs LOGCONC Graph Type PT TO PT ESC Y vs X ABS vs CONC TYPE SCALE LINEAR LOGABS vs CONC ABS vs LOGCONC PT TO PT LOGITABS vs LOGCONC ABS vs CONC 4 PARAMETER LOGABS vs LOGCONC Graph Type 4 PARAMETER ESC Y vs X ABS vs CONC TYPE SCALE LINEAR LOGABS vs CONC ABS vs LOGCONC PT TO PT LOGITABS vs LOGCONC ABS vs CONC 4 PARAMETER LOGABS vs LOGCONC UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 52 of 117 Select the scale type touching the required zone I Selection of Controls For High control select touch zone HI CO N Following message appears High Control Required Y
49. Procedure A solution of 5 Sodium Hypo Chlorite NaOCL solution Bleach is used Commercial bleach is 5 NaOCL household bleach is 3 NaOCL When using commercial bleach use a 10 1 mixture if using household bleach a 6 1 mixture is required This is a caustic solution It is important to wear gloves and eye protection when handling it Wipe down the carrier and all exposed surfaces of the unit with the bleach solution Remove the top shroud of the instrument and wipe down the top surface of the instrument base as well as the inside of the top shroud Rinse all the decontaminated carrier and exposed surfaces will distilled water Reassemble the unit and discard the used gloves and towels UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 116 of 117 20 SAFETY CLEARANCE CERTIFICATE Please complete all information requests on this form prior to returning the instrument to the manufacturer or your local distributor for servicing repairs or return Thank you for your co operation Customer Contact Address Position Dept Tel Country Fax Post Code Model No Serial No Accessories Returned Date of Purchase if known Complaint Has the equipment been exposed to any of the following delete as applicable a Blood body fluids pathological specimens YES NO If YES please specify UUsseerr M Maannuuaall
50. QC4 N Range Pos 0 000 Neg 0 000 Pri 405 ESC Sec 560 Select Filter Val 0 405 450 492 630 NA NA 560 YYY UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 30 of 117 F Entry of Blank and Blank QC values Select BL to enter blank details G After selecting BL enter total number of blanks by selecting No of Blanks Maximum 5 blank H Enter the QC value of the blank by selecting the touch Zone Values of BL lt Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 0 Y 0 000 0 000 NC 0 1 000 Y 0 000 0 000 PC 0 1 000 Y 0 000 0 000 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 No of Blanks 1 Values Of BL lt 0 000 Numeric Value 1 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR No of Blanks 1 Values Of BL lt 0 000 Numeric Value 0 100 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 31 of 117 I Entry of Negative control and its QC values Select touch Zone NC Enter N of Negative controls by selecting touch Zone N of NC s maximum 5 Negative Controls Enter the
51. SAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 26 of 117 8 2 Single Standard In this mode the instrument accepts the calibrator singly or in duplicate and then calculates the concentration based on the single point standard curve passing through the point 0 000 A single calibrator standard of a known concentration is used to calibrate the instrument so that the concentration of unknown samples can be calculated according to Beer s Law The absorbance are read at user selected wavelengths If Blank is selected instrument will automatically blank on the first well and subtract its absorbance from each subsequent well The second well is treated as the calibrator standard well The third well is also treated as calibrator standard well if the calibrator standard is in duplicate CALCULATION Sample Concentration Calibrator concentration Calibrator Abs x Sample Abs CALCULATION Sample Concentration Calibrator concentration Calibrator Abs x Sample Abs Entry of all the parameters is similar to Multi standard mode Please refer Multi standard for entry of parameters Name SIN_560 SINGLE STANDARD Pri 560 Sec 0 BL Y 0 000 CAL 1 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 27
52. SC 2 Set Password 3 LOGIN 4 LOGOUT UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 101 of 117 Enter PASSWORD and select ENTER Enter appropriate USER name and select ENTER 15 10 2 SET PASSWORD This option helps to set the PASSWORD along with the USER name USER TANIYA A B C D E F G H I J K L M N O P ENTER Q R S T U V W X CLR Y Z _ 1 2 3 4 5 6 7 8 9 0 Password Utility 1 Enable Disable ESC 2 Set Password 3 LOGIN 4 LOGOUT ESC ADMIN PASSWORD A B C D E F G H I J K L M N O P ENTER Q R S T U V W X CLR Y Z _ 1 2 3 4 5 6 7 8 9 0 Password Utility 1 Enable Disable ESC 2 Set Password 3 LOGIN 4 LOGOUT ADMIN PASSWORD A B C D E F G H I J K L M N O P ENTER Q R S T U V W X CLR Y Z _ 1 2 3 4 5 6 7 8 9 0 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 102 of 117 15 10 3 LOGIN After entering the Password user needs to select LOGIN 15 10 4 LOGOUT Password Utility 1 Enable Disable ESC 2 Set Password
53. TANDARD Pri 560 Sec 0 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 Load Calibrators YES NO UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 84 of 117 NOTE User can view the Saved Graph from the Test parameter screen before running the same test On selecting GRAPH option it will display following screen where user can select PLOT option in order to view the Valid GRAPH Screen Name TSH MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y EDIT RUN HI CO Y High gt 25 03 Low lt 10 54 PRINT LO CO Y High gt 16 61 Low lt 5 45 Interpret n Y Range High gt 15 25 Low lt 9 46 Graph 4 PARAMETER Y vs X ABS vs CONC To change values press EDIT No Conc Abs No Conc Abs 1 0 000 0 220 2 10 00 0 454 3 25 00 0 725 4 50 00 1 026 5 100 00 1 269 6 150 00 1 850 7 200 00 2 000 ESC PRINT PLOT UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 85 of 117 The Graph screen will be displayed as shown below 11 SAMPLE AND SAMPLE DUPLICATE While loading the samples you can load a single sample in single well or a single sample in adjacent two well and finally the instrument will take the average of it as known as Sample Duplicate The instrument will load the controls ca
54. UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 1 of 117 ELISA PLATE READER DIA2000 DIAsource ImmunoAssays S A Rue du Bosquet 2 B 1348 Louvain La Neuve BELGIUM Phone 32 10 84 99 11 Fax 32 10 84 99 90 www diasource be IVDInstrumentation support diasource be Version 3 400A UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 2 of 117 TABLE OF CONTENTS 1 GENERAL INFORMATION 5 1 1 Warranty Information 5 1 2 Technical Service 5 1 3 Contacts 5 2 GENERAL SAFETY WARNINGS 6 2 1 Danger warning symbols 6 2 2 Use of the Instrument
55. Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS 0 45 NC 0 35 PC 0 10 QC1 gt Y Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 38 of 117 Enter equation of QC and value of QC check by selecting touch zone QC1 Value and QC1 equat Same way you can enter QC equations for QC2 QC3 and QC4 NOTE On screen it is mentioned that QC1 gt Y In most of the reagent inserts it is mentioned that QC value should be greater than some constant value Sometimes in the box insert it is mentioned that the value should be less than some constant value In such case you can change the symbol from QC1 gt Y to QC1 lt Y only by selecting a symbol of comparison If any QC check is selected to YES option the system will not save the test without entering the QC equation and QC check value of equation Enter QC Value and Equation QC1 Value 0 500 QC1 Equat Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR Enter QC Value and Equation QC1 Value 0 000 ESC QC1 Equat QC Equat PC NC NC PC LC CC SA ENTER CLEAR 1 2 3 4 5 6 7 8 9 0 Sqrt Log ALog Ln ALn Abs Enter QC Value and Equat
56. actor and select ESC option to come out to the test parameter screen O Entry of Cut off Factor Select touch Zone CUT FAC After selecting the CUTFAC following screen will come on the display After selecting the CUTFAC it will display following screen Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 ESC Value of Cut Factor 0 000 ESC Value of Cut Factor 0 200 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 35 of 117 For entering the CUTABS equation user has to select CUTABS present on the screen Now enter the equation as given in the reagent manual or else select ESC option in order to come out of the CUTABS screen P Entry of Cut off absorbance equation Select touch Zone CUTABS After selecting the CUTABS below screen will come on the display Whereas NC Mean of NCs Factor X Sqrt Square root PC Mean of PCs Factor Y Lg LOG Aln Anti Natural LOG LC Mean of LCs Factor W Ln Natural LOG CC Mean of CCs
57. al Put copy of Safety clearance certificate copy of Safety clearance certificate is attached at the end of this manual 3 Mark the packaging with address instrument identification and warning labels 4 3 Instrument Transportation The transportation of the instrument in unpacked condition must be limited within the room where it is used to avoid damage 4 4 Storage of Instrument Before storing the instrument for a long period pack it carefully as described above and store indoors Relative humidity can be up to 80 and temperature between 10 C and 40 C UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 12 of 117 5 INSTRUMENT DESCRIPTION 5 1 Instrument Working Principle 1 Switch on and program the instrument 2 Place the plate firmly onto the carriage 3 Start the test the plate will be conveyed inside and strip is placed precisely below the optical path The measurement is carried out step by step At the end of the cycle the results are printed at the same time they are available at the RS232 serial port output On starting the test the plate will be conveyed into the instrument Plate is moved in step by step by a well controlled mechanism and each well is positioned precisely below the optical path Optical density of each well is measured as explained below Based on selected programming mode sophisticated algorithms are used
58. and reagents reagent and control expiry dates need to be checked 7 PRECAUTIONS Do not use any sharp objects on the Touch Screen Always use the STYLUS provided to operate the touch panel Always check for proper grounding before installation Never operate the instrument when ground wire is removed 3 Do not attempt to open the instrument and make repairs without proper technical training Do not allow unauthorized persons to operate or repair the instrument 4 Use a clean plate and follow the instructions for blanking and standardizing Do not read any wells containing bubbles or dust particles 5 The volume of sample calibrators and blanks should be identical for correct readings The absorbance is proportionate to the path length Pipetting should also be proper UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 23 of 117 6 Monitoring of the printed values or displayed values during operation may help detect an error Check the linearity and calibration of the instrument regularly against some standard reference 7 Check the micro wells before use They should be scratch free The micro well track in the ELISA READER has been designed in such a way that the micro wells are totally protected from scratches Recheck the reading of high OD above 2A 9 Place Plate carefully on the tray 10 Ensure that the main power switch is in OFF position before connect
59. aph if any in order to maintain the record of the plate run in the form of hard copy Auto Print is active in all modes excluding ABS mode For Auto Print user must set the printer ON otherwise it will display the error string Disable printer YES NO NOTE The option 8 CV Diagnostic OFF is not for users It is for factory use only UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF Install USB Drivers YES NO UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 100 of 117 15 10 PASSWORD Select Password option in order to Set the Password so that one can t ADD EDIT DELETE and SEND RECEIVE Test records without entering the valid Password 15 10 1 ENABLE DISABLE Enable Disable helps the user to set the Password or Remove the Password from the Password Utility Enter Password with the help Alphanumeric screen which is displayed after selecting Enable Disable option Password Utility 1 Enable Disable E
60. ay as shown below To enter concentration values select 0 000 in Conc column corresponding to the standard and enter the concentration value e g for entering Concentration of standard 4 Select 0 000 in fourth row of Conc Column and enter the concentration by selecting the numerals Note The concentration value should be either in ascending or descending order No Of Calibrator 2 ESC No Conc Abs 1 0 000 0 000 2 0 000 0 000 No Of Calibrator 2 ESC No Conc Abs 1 0 000 0 000 2 0 000 0 000 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR No Of Calibrator 7 ESC No Conc Abs No Conc Abs 1 0 000 0 000 7 10 00 0 000 2 0 500 0 000 3 1 000 0 000 4 2 500 0 000 5 5 000 0 000 6 7 500 0 000 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 48 of 117 Screen after entry of calibration will be displayed as follows G Selection of Duplicate Blank and calibrators For Duplicate Blank Select touch zone DUP below the BL Y After selecting DUP instrument will display message Duplicate Blank Yes No as shown below Select Yes for Duplication of Blank Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpre
61. bsorbance 0 2 gt Single Standard 0 3 gt Cut off 0 4 gt Multi Standard 0 5 gt Percent Absorbance 0 6 gt Uptake 0 7 gt Kinetic 0 TEST OPERATIONS ESC 1 Select Test By Name 2 Select Test by Mode 3 Select Test by Number 4 List Tests 5 Add New Test UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 45 of 117 Select the Filters as per details given in the reagent manual C Entry of Test Name Test Name can be entered by Selecting Touch Zone Name Procedure for entering the test name is the same as the one of cut off mode Refer Test Name entry in Cut off mode for further details D Selection of Primary and secondary filters Select Touch Zone Pri Pri 405 ESC Sec 0 Name MUL_4P MULTISTANDARD Pri 405 Sec 0 BL N CAL 2 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC Pri 560 ESC Sec 0 Select Filter Val 0 405 450 492 630 NA NA 560 YYY UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 46 of 117 E Selection of Blank Select Touch Zone BL Select Touch Zone BL Instrument will display the message Blank required Yes No at the bottom of the Screen select Yes if blank
62. elect Test 1 HBSAg 6 PER_ABS RUN SEL 2 HCVAb 7 CRP PRNT 3 UPT 8 KIN_405 NEXT 4 TSH 9 SIN_630 PREV 5 CPC 10 CP_560 DEL PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 20 of 117 6 7 Touch Panel Check ELISA READER provides a Touch sensitive LCD panel and a KEYPAD for easy use interface The Menus are displayed and the text of the parameter forms the TOUCH ZONE Touch screen Layout Above is the generic representation of a Test Screen The Highlighted zones are TOUCH ZONES which are active On touching the Touch Zone of a parameter a sub menu menu is displayed or the requested action is carried out The rest of the Touch Zone is deactivated For Example To activate the selection Enter the primary filter value to touch any point in the shaded area Pri on the LCD screen On proper selection the analyser responds with blinking of the parameter text and also the TOUCH ZONE and a submenu is displayed To enter Test Name Touching the Name touch zone provides an alphanumeric screen Enter the Test name by touching the Touch zone of that variable The selected value blinks and is displayed next to the parameter Selection Indicator Selected on screen item is shown in a shaded background When the screen first displays the default selection is shown Pressing a selection either highlights that item or
63. err M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 96 of 117 15 3 Printer On Off setting Its a toggle between Printer ON and Printer OFF 15 4 Enter Clinic Name Type your Clinic Name and select ENTER The character length is maximum 19 characters UTILITIES Version 3 400A CLINIC TATA_MEMORIAL A B C D E F G H I J K L M N O P ENTER Q R S T U V W X CLR Y Z _ 1 2 3 4 5 6 7 8 9 0 UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 97 of 117 The total shake time can be entered in seconds Regarding the Shake Speed there are 10 types of speeds You can choose any speed by entering numbers from 1 to 10 The shaking speed increases as the number increases 15 5 Shaker Plate Shaking Mode Shaker is used for shaking the plate before running any test The Shaker screen is displayed as foll
64. es No Select YES and then enter range of control HIGH and LOW Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph 4 PARAMETER Y vs X ABS vs CONC Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph 4 PARAMETER High Control Required YES NO UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 53 of 117 Enter range of control HIGH and LOW as per reagent manual Similarly for Low Control select touch zone LO CO N It will display the message Low Control Required Yes No Select YES and then enter range of control HIGH and LOW Note Entry of LO CO is similar to that of HI CO Enter High Range Value ESC High 0 000 Low 0 000 Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y SAVE HI CO N High gt 25 03 Low lt 10 54 LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph 4 PARAMETER Low Control Required YES NO Enter High Range Value ESC High 25 03 Low 10 54 Numeric Value
65. eyzone option the Cut off Index Range option will not work Enter Value ESC UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 40 of 117 NOTE If you don t select any option for interpretation of sample results the instrument will take Cutoff Absorbance as a reference It will give Positive remark to sample absorbance greater than cutoff and Negative to sample absorbance less than cutoff Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS NC PC CF QC1 gt Y 0 500 Interpretation QC2 N Greyzone Y 10 00 QC3 N Cut off Index N QC4 N Range UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 41 of 117 R 2 Interpretation by Cutoff Index Range It is also provided to do the interpretation using Cutoff Index by entering normal range for Positive and Negative RESULT RANGE ESC POSITIVE gt 0 000 NEGATIVE lt 0 000 Name HBSAG POS CutOff Pri 405 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200
66. for analyzing the measured value and presenting the same on the printer display amp RS232 serial port for computer Interface The following diagram represents the main functional elements of the instrument White light produced by the lamps is focused into a beam by the lens and passes through the sample Part of the light is absorbed by the sample and the remaining light is transmitted It is filtered by interference filters and focused onto the photodiodes The photodiode converts the received light into an electrical signal which is transformed into a digital form from which the microprocessor calculates the absorbance taking in account of the blank and bichromatic selection UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 13 of 117 Amplifier Analogue to Digital Converter Micro Processor Key Pad Touch Panel Printer RS232 Display Lamp Lens Lens Lens Photo sensor Memory Filter Wells UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 14 of 117 5 2 Perspective View Front View Rear View 1 Contrast Knob use to adjust display contrast 2 Serial RS232 output 3 Cooling Fan 4 USB output Plate Carrier Holder Keypad Touch Screen Printer 1 2 3 4 5 6 7 Contrast knob Cooling Fan Serial RS232 O P Ext Printer c
67. g tests Multiple calibrator modes Selection of duplicates for both calibrators and samples Extensive software for cut off mode Selection of Positive Equivocal Negative cut off UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 9 of 117 Several pre programmed calculation modes will help to facilitate data processing of enzyme immunoassays These are menu driven modes for simple and error free operations ABSORBANCE MODE CUT OFF MODE MULTISTANDARD MODE SINGLE CALIBRATOR MODE ABSORBANCE MODE UPTAKE KINETIC 3 3 Technical Specification Human Machine Interface TOUCH PANEL KEYPAD Linear measurement range 0 000 to 3 000 Absorbance Units A Photometric Accuracy 2 or 0 007 whichever is higher from 0 to 1 5 A 3 from 1 5 A to 3 0 A Drift lt 0 005 A hr Photometric Linearity 2 5 A Optical measurement 8 Channel Filters Type of filter Wave Length Half Bandwidth Selection Narrow band Interference 405nm 450nm 492nm 630nm 560nm 10nm 2nm Automatic by Stepper Motor Light Source Display Curve Plotting Tungsten halogen lamp 20 Watts 6 Graphics LCD Negative Blue STN Graphical Representation on Printer UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 10 of 117 Plate Carrier Movement
68. he value of cut of factor CUT FAC 0 100 This is because here NC Mean of NCs Factor X PC Mean of PCs Factor Y as mentioned above If CUTOFF ABS NC PC 6 This can be entered as it is CUTABS NC PC 6 by keeping the multiplication factors X Y W Z of controls NC PC CC and LC a constant number 01 OR As you know in mathematics NC PC 6 NC 6 PC 6 1 6 NC 1 6 PC 0 166 NC 0 166 PC So you can enter same equation as CUT ABS NC PC by entering Multiplication Factor for NC X 0 166 multiplication factor for PC Y 0 166 This is because here NC Mean of NCs Factor X PC Mean of PCs Factor Y as mention above _______________________________________________________________________________ UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 37 of 117 Q QC1 QC2 QC3 amp QC4 can be used for any QC Checking of the test provided in reagent manual For example some kit may give QC check equation like PCx NCx gt 0 500 PC NC gt 15 etc This equation can be entered by selecting these QC options Select touch zone N You will obtain Y as shown in screen below by selecting touch zone QC1 and entering QC equation Name HBSAG POS CutOff Pri 450 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000
69. ing 11 Plug the instrument to the AC mains Confirm proper grounding for trouble free operation 12 Connect the printer only when the instrument is OFF 8 PROGRAMMING MODES We would like to highlight that the assay protocols reported in this section correspond to illustrations When programming the instrument the end user must always refer to the instruction for use specific to each assay 8 1 Absorbance Mode In this mode the instrument gives only absorbance of all wells of plates of the respective plate UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 24 of 117 Programming a New Test A Select Test Operation B Select Add New Test C Select mode of operation Absorbance in Add new test D Enter Test Name MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial Communication TEST OPERATIONS 1 Select Test By Name ESC 2 Select Test by Mode 3 Select Test by Number 4 List Tests 5 Add New Test Select Test Mode 1 gt Absorbance 0 2 gt Single Standard 0 3 gt Cut off 0 4 gt Multi Standard 0 5 gt Percent Absorbance 0 6 gt Uptake 0 7 gt Kinetic 0 NORM ABSORBANCE Name BL N ESC Pri 405 Sec 0 NORM MODE DIFF NORM ABSORBANCE Name ABS 560 A B C D E F G H I
70. instrument to another For instance let us take an example which will show how the Test Records are transferred from instrument to instrument Let Instrument 1 resemble the screen of the Instrument which will receive the Test Records from other instrument And Instrument 2 resemble the screen of the Instrument which will send the Test Records to other instrument SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Download Test Records YES NO SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Download Test Records YES NO MAIN MENU ESC 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial communications UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 108 of 117 Instrument 2 Select YES in order to send all the test records Now for Sending Test Records switch on to Instrument 2 And similarly Instrument 1 will display the following screen which denotes that the instrument is downloading the Test Records After completing the process of transferring the data one must restart both the instrument and check for the data transferred between the instruments In this way one can transfer Test Record
71. ion QC1 Value 0 000 ESC QC1 Equat UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 39 of 117 R Interpretation of samples Enter RANGE for interpretation of results either in percentage Greyzone or positive and negative values of INDEX as a ratio of Sample Abs Cutoff Abs If Cutoff Index range or Greyzone is not mentioned do not enter any values Instrument will do the interpretation with references to the Cut off absorbance R 1 Interpretation by GREYZONE percentage Select touch zone Greyzone N Select touch zone Greyzone N Name HBSAG POS CutOff Pri 405 Sec 560 ESC No Factor QC QCVal Mes Rem SAVE BL 1 Y 0 100 NC 3 1 000 Y 0 150 PC 2 1 000 Y 0 500 LC 0 1 000 N CC 0 1 000 N CUTFAC 0 200 CUTABS NC PC CF QC1 gt Y 0 500 Interpretation QC2 N Greyzone N QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 Enter Value Value 10 00 Numeric Value 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR Enter Greyzone percentage value Select ESC option after entering Greyzone value to come out to the parameter screen If you enter Greyzone percentage 10 00 instrument will show you the same as shown in screen It makes the Cutoff Index Range option NO This means when you are using a Gr
72. ion infection or contamination might occur Pay attention to the general safety warnings when in presence of such biological substances Use protective clothes gloves and glasses This symbol in the user manual indicates that damages to the instrument or erroneous results could occur if the given warnings are not respected This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 7 of 117 2 2 Use of the Instrument 1 The instrument has to be used for the designed purposes under specified conditions following proper procedures and safety rules by qualified personnel 2 This manual contains instructions for operation performed by qualified personnel 3 A qualified user has to make sure that environmental condition is suitable the installation is correct the use and maintenance are proper according to the general safety rules as well as to the particular precautions described in the manual However he is not entitled to repair the instrument 4 A qualified technician is entitled to maintain and repair the instrument using the original spare parts according to the given instructions 5 Maintain room temperature and humidity as specified in the manual 6 If the instrument is not used as described in the manual the
73. is required F Entry of Standard Concentration Select touch Zone CAL to enter Number of calibrators and its concentration After selecting CAL it will display following screen Select Touch Zone No Of Calibrators Numeric screen will be displayed at the bottom of the screen Select the number of calibrators User can select min 2 and max 12 standard in this mode Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL N CAL 2 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL N CAL 2 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Blank Required YES NO Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 2 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 47 of 117 Whereas in case of 4 Parameter user can select min 5 and max 12 calibrators Concentration Entry After entering the number of calibrators concentration and absorbance column will come on the displ
74. librators automatically in any new test or not accepted test You have to provide the number of samples If you are loading single samples keep DUP No Select No of Samples to enter total samples While loading the samples you can load a single sample in single well or a single sample in adjacent two well and finally the instrument will take the average of it known as Sample Duplicate The instrument will load the controls calibrators automatically in any new test or not accepted test You have to provide the number of samples If you are loading single samples keep DUP No Select No of Samples to enter total samples Origin at X 0 000 y 0 000 X div 2 500 y div 0 150 ESC 3 000 PRINT EDIT 2 000 1 000 0 001 0 000 10 00 20 00 40 00 Name HCV POS Cut Off Pri 450 Sec 560 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B NC UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 86 of 117 If you want to load duplicate samples select DUP option and then enter the number of samples by selecting No of Samples Name HCV POS Cut Off Pri 450 Sec 560 ESC No of Samples 0 RUN DUP Y SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B NC NC NC PC PC Name HCV POS Cut Off Pri 450 Sec 560
75. mber 1701327 Page 73 of 117 You can get the print in matrix format by selecting PRINT MATRIX In matrix form you will get the print as per your plate for all the wells Instrument will print seven different parameters in print matrix for a single well as follows ROW IDENTIFICATION A B C D WELL NUMBER W1 W2 W3 W4 WELL ID OR SAMPLE NUMBER B C1 C2 C3 OR S1 S2 S3 PATIENT IDENTIFICATION LUCAS DUPONT etc WELL ABSORBANCE 0 050 0 098 0 085 SAMPLE CONCENTRATION 0 738 0 689 2 578 INTERPRETATION REMARKS POS NEG EQ Remember that Negative sign result is interpreted as zero both in printout as well as on screen UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 74 of 117 Example Print out of MultiStandard test obtained from ELISA Reader UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 75 of 117 G By selecting option View Graph key the graph appears on the screen with all the details of X axis and Y axis Select PRINT option to obtain the print out Select ACCEPT TEST option to save this test with the details of calibrator absorbance It is possible to run the same test without loading calibrators The previous graph can be used for new samples NOTE If you do not want to run the calibrators each time please
76. ment Working Principle 12 5 2 Perspective View 14 5 3 Keypad 15 6 INSTALLATION PROCEDURE AND VERIFICATION CRITERIA 17 6 1 Unpacking Instructions 17 6 2 Placing the Instrument 17 6 3 Power Supply Requirements 17 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 3 of 117 6 4 Protective Grounding 17 6 5 Printer 17 6 6 Start up Instructions
77. ne can t enter the PID with 1 Alphabet and 6 Numbers since its maximum numeric count is 65500 Note The same combinations should be used during SEQUENTIAL entry also B Sequential Patient ID Entry This one by one entry will take more time therefore one more option to enter Patient Ids is provided This option is SEQL sequential entry If you select PID option for patient ID entry the following question appears on the screen Delete Previous PIDs Yes No If you select NO it will directly load the previously entered PIDs for sample and if you select YES it will delete the previous PIDs Now select SEQL it will display Alphanumeric screen where user can enter different sequential PIDs Follow the steps below Enter Alphabets PRST A B C D E F G H I J K L M N O P ENTER Q R S T U V W X CLEAR Y Z _ 1 2 3 4 5 6 7 8 9 0 Enter Initial Sample number Numeric Value 01 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR Enter last sample number Numeric Value 10 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR Enter initial PID number Numeric Value 123 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR S S UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 90 of 117 The final screen will appear which displays the sequential IDs of patient samples for the well location that is selected Go to the next and previou
78. nstruments The user should carry out ordinary maintenance 1 3 Contacts DIASOURCE IMMUNOASSAYS S A Rue du Bosquet 2 BE 1348 Louvain La Neuve BELGIUM IVD Instrumentation Support Service Hotline phones availabilities Monday to Friday 08 30 to 17 00 Belgium time Please contact first Hotline 1 In case of no response please contact Hotline 2 Hotline 1 phone number 0032 0 10 849932 Hotline 2 phone number 0032 0 10 849976 Fax 0032 0 10 849990 Email IVDInstrumentation support diasource be UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 6 of 117 2 GENERAL SAFETY WARNINGS 2 1 Danger warning symbols This is a symbol of generic danger It means that serious damage can occur to the operator if described precautions are not observed This is a symbol of HIGH ELECTRIC VOLTAGE It is dangerous to touch any part having this label Only qualified operators can access these components after unplugging the instrument from the supply This symbol indicates that the instrument makes use of chemical reagents and other dangerous Corrosive irritant or harmful CHEMICAL SUBSTANCES which can cause damage to people or materials When this label is found pay attention to the manufacturer s recommendations This symbol indicates that the instrument involves the handling of samples which can be infected urine or human serum In this condit
79. of 117 8 3 Cut Off Mode In this mode cut off point is determined for interpretation of specimens as per formula given in the reagent manual The negative controls are read followed by the positive controls Cut off control low positive control Blanking on the first well is optional The instrument calculates the average of the negative controls and the average of the positive control Cut off controls and Low positives are also calculated Programming a New Test A Select Add New Test B Select mode of operation Cut Off in Add new test Select Test Mode 1 gt Absorbance 0 2 gt Single Standard 0 3 gt Cut off 0 4 gt Multi Standard 0 5 gt Percent Absorbance 0 6 gt Uptake 0 7 gt Kinetic 0 TEST OPERATIONS ESC 1 Select Test By Name 2 Select Test by Mode 3 Select Test by Number 4 List Tests 5 Add New Test UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 28 of 117 C Entry of test name Select touch Zone Name Alphanumerical characters will appears on the screen as shown below after touching Name on the screen Enter the name of the test by selecting the individual characters one by one After selecting all the characters select Enter option in touch screen for confirmation of test Name Name POS CutOff HBSAG A B C D E
80. on done in each well It is showing the D M values for each and every well in table format Name KIN_560 KINETIC Pri 560 Sec 0 D M D M D M D M D M D M 1 2 3 4 5 6 D M D M D M D M D M D M 7 8 9 10 11 12 Is Plate Loaded YES NO Name KIN_560 KINETIC Pri 560 Sec 0 D M D M D M D M D M D M 1 2 3 4 5 6 D M D M D M D M D M D M 7 8 9 10 11 12 Is Plate Removed YES NO Name KIN_560 KINETIC Pri 560 Sec 0 D M D M D M D M D M D M 1 2 3 4 5 6 0 020 0 002 0 010 0 035 0 056 0 001 0 030 0 056 0 075 0 100 0 068 0 090 D M D M D M D M D M D M 7 8 9 10 11 12 0 020 0 002 0 010 0 0 35 0 056 0 001 0 030 0 056 0 075 0 100 0 068 0 090 ESC PRINTMATRIX SEND PLATE LOAD NEXT UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 79 of 117 In PRINT MATRIX you will get the print of entire plate data with initial absorbance of each sample average delta values of each sample and D M values of each well like A W1 W2 W3 W4 W5 W6 0 200 0 100 1 200 0 300 2 600 0 900 these are initial absorbance 0 010 0 001 0 005 0 017 0 028 0 001 these are average delta values 0 020 0 002 0 010 0 035 0 056 0 001 these are D M values of each
81. onnection SMPS On Off switch USB output UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 15 of 117 5 3 Keypad 1 YES key is used to select any YES option on screen directly 2 NO key is used to select any NO option on screen directly 3 PRINT key is used to get a printout of current screen displayed 4 TEST key is used for directly accessing the RUN screen of the selected test 5 Navigation keys are used to select any option available on current screen 6 ENTER key is used to run any option selected by navigation keys 7 ESC key is used for escaping from any screen 8 SHAKE key is used for directly accessing the shaking mode ie SHAKER refer 15 5 for more details on SHAKER Note Functions based on HOME amp FEED keys operates only when it is in List Test screen or the first screen after initializing ELISA READER 18 07 12 Clinic name Serial Number MENU Select Test 1 HBSAg 6 PER_ABS RUN SEL 2 HCVAb 7 CRP PRNT 3 UPT 8 KIN_405 NEXT 4 TSH 9 SIN_630 PREV 5 CPC 10 CP_560 DEL PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 16 of 117 User can select List Test screen as shown below Select TEST button present on the keypad It will display following screen for selecting
82. ows After entering shake time and shake speed select Start option When Start is selected the tray will come out and on the screen you will obtain a message Is plate loaded Yes No Load the plate and select YES option After selecting YES the tray will go inside and instrument will do the shaking of plate for the given time period with selected speed Shake Time 0 sec ESC Shake Speed 0 Start Stop Shake Time 0 sec ESC Shake Speed 0 Start Stop Numeric Value 20 1 2 3 4 5 6 ENTR 7 8 9 0 CLR Shake Time 20 sec ESC Shake Speed 0 Start Stop Numeric Value 05 1 2 3 4 5 6 ENTR 7 8 9 0 CLR Shake Time 20 sec ESC Shake Speed 5 Start Stop Shake Time 20 sec ESC Shake Speed 5 Start Stop Is Plate Loaded Yes NO UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 98 of 117 When the shaking is finished the plate holder will come out and display a message Is plate removed Yes No Remove the plate and select YES to end the process Similarly to stop the Shaking process in between select STOP option present on the screen After selecting STOP option it will display the message string Is Plate Removed YES NO Select NO to terminate the ongoing process Note HOME key is also used for directly accessing the shaking mode ie SHAKER 15 6 Communication Setting
83. protection provided by the instrument may be impaired 7 Alterations to the instrument are prohibited The user is liable for any improper Modification to the instrument and for the deriving consequences 8 Contact the MANUFACTURER service or authorized service center in case the instrument need extraordinary maintenance Specialized technicians who will be able to repair the instrument using original spare parts will carry out the maintenance 9 This IVD equipment complies with the emission and immunity requirements as per IEC61326 series 10 Warning This equipment has been designed and tested to CISPER11 Class A In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference 11 An advisory that the electromagnetic environment should be evaluated prior to operation of the device 12 Warning Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded international RF sources as these may interfere with the proper operation UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 8 of 117 3 INTRODUCTION 3 1 Description The ELISA PLATE READER is a user friendly micro plate Analyser It is compact amp lightweight It is designed to measure and interpret enzyme immunoassay results both monochromatically and bichromatically It is intended fo
84. r in vitro diagnostic use 3 2 Special Features The ELISA READER can accommodate a flat bottom as well as a round configuration The carriage is designed in a way that the plate automatically moves smoothly and positions iself accurately in the optical measurement path Readings are taken continuously The average value is calculated and results are presented according to the option selected The ELISA READER operates on a WIDE voltage 90 270 volt This eliminates the need for an external voltage stabilizer The ELISA READER has a special provision which allows it to be used even when a printer is not available Readings can be conveniently noted down manually The other special features of ELISA READER are as follows Option of Lamp saving mode Selection of both primary and secondary filters Latest technology with battery back up for 250 tests with QC more than 2500 result Robust built in 52 column thermal printer with 384 stationary heads Unique circuitry for long lamp life Alphanumeric Patients ID entry Editing of saved tests Human machine user interface Touch panel Keypad Multi standard curve up to 12 standard calibrations with one blank optional Access to test by touch of key Capability to connect to 80 column printer for direct report printout Blank is optional Setting of the Date and Time Capable of storing deleting and recallin
85. s It is a toggle between USB and SERIAL communication User can either switch to USB or Serial communication by connecting their respective cables This setting is very important whenever you want to transfer data from instrument to computer You can transfer data either using USB or by Serial RS232 cable Shake Time 20 sec ESC Shake Speed 5 Start Stop Is Plate Removed Yes NO UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings SERIAL 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UTILITIES Version 3 400A 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 99 of 117 15 8 Install USB Driver This option present in the Utilities helps the user to install the USB Drivers in their respective computers Remember that before installing the USB drivers you must first switch on to the USB communication settings 15 9 Auto Print ON It is a toggle key between Auto Print ON and Auto Print OFF After completing the running process it automatically takes the print of the result and its gr
86. s from instrument to instrument SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Send Test Records YES NO SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records Sending MAIN MENU ESC 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial communications SERIAL COMM ESC 1 Send Results 2 Send Test Records 3 Receive Test Records 1248 UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 109 of 117 3 User can Send and Receive the Test Records only through serial cable and therefore one has to set the Serial Communication SERIAL in Utilities If Serial Communication is set to USB then it will display following screen 17 TECHNICAL DIAGNOSIS Technical Diagnosis is present in Main Menu 17 1 Clear Memory This option is used to clear entire saved test records and entire saved patient results along with saved plates The Test Records are the different kind of programmed test that are made in different modes of operation and saved in instrument program memory MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial Communication TECHNICAL DIAGNOSIS ESC 1 Clear Memory 2 Lamp Amplitude 3 Printer Self test 4 Lamp Centering Check SERIAL COMM ESC
87. s screen with the help of NEXT and PREV option present on the screen NOTE The entered PID get stored in instrument memory until you delete it by using option Delete previous PIDs Yes NO 13 SAVE PLATE AND SAVE RESULTS In all modes of operation there are two options provided to store results A In cut Off mode Name HCV POS Cut Off ESC Pri 450 Sec 560 BL Y Range PERCENTAGE 10 00 NXT NO SAMP ABS AVG CONC REM PID PREV A1 B 0 050 0 050 B1 NC PRINT SAVE PRINT PLATE RESULTS RESULTS MATRIX OPT Sample PID ESC 1 PRST123 2 PRST124 3 PRST125 4 PRST126 5 PRST127 6 PRST128 NEXT 7 PRST129 8 PRST130 PREV 9 PRST131 10 PRST132 SEQL UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 91 of 117 B In Multi standard or any calibrator mode If PLATE OPT is selected you will obtain two options 1 SAVE PLATE DATA it helps the user to save the entire plate information along with the control calibrator information maximum 10 plates data can be saved 2 SEND PLATE DATA is used to send the data from instrument to computer through USB or serial RS232 connection If SAVE RESULT option is selected the information of samples only except controls calibrators with test name patient ID and date will
88. sion 150511 PI number 1701327 Page 55 of 117 Same way you can make a test for Single standard Absorbance and uptake 8 6 Percentage Absorbance The Percentage Absorbance Mode requires one calibrator read singly or duplicate In this mode calibrator is considered to have a concentration of 100 The absorbance s of unknown samples are read and compared to the calibrator absorbance and reported as concentration of calibrator Refer 8 5 for parameter entry 8 7 Uptake In this mode the instrument accepts the calibrator singly or in duplicate and then calculates the concentration based on the single point standard curve passing through the point 0 000 A single calibrator standard of a known concentration is used to calibrate the instrument so that the concentration of unknown samples can be calculated according to Beer s Law Sample Concentration Calibrator Absorbance Calibrator Concentration Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y SAVE HI CO Y High gt 25 03 Low lt 10 54 LO CO Y High gt 16 61 Low lt 5 45 Interpret n Y Range High gt 15 25 Low lt 9 46 Graph 4 PARAMETER Y vs X ABS vs CONC Name ABSORBANCE Pri 405 Sec 0 BL Y 0 000 CAL 1 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt UUsseerr M Maannuuaall EELLIISSAA PPLL
89. t n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Duplicate Blank YES NO Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 49 of 117 For Duplicate Calibrators To select Duplicate Calibrator select Touch Zone DUP below the CAL 7 After selecting DUP instrument will display message Duplicate Calibrator Yes No as shown below Select Yes for Duplication of calibrators Screen after standard entry amp selection of duplicate Blank amp Calibrators Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Graph LINEAR Y vs X ABS vs CONC Name MUL_4P MULTISTANDARD Pri 560 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP Y SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret
90. t ESC 1 HBSAG RUN SEL 2 TSH PRNT 3 HCV NXT 4 MUL_4P PREV 5 CP_560 DEL PLATE DATA Name HCV NORM ABSORBANCE Pri 450 Sec 560 BL N ABS ABS ABS ABS ABS ABS 1 2 3 4 5 6 ABS ABS ABS ABS ABS ABS 7 8 9 10 11 12 Is Plate Loaded YES NO Name HCV NORM ABSORBANCE Pri 450 Sec 560 BL N ABS ABS ABS ABS ABS ABS 1 2 3 4 5 6 ABS ABS ABS ABS ABS ABS 7 8 9 10 11 12 Is Plate Removed YES NO TEST OPERATIONS 1 Select Test By Name ESC 2 Select Test By Mode 3 Select Test By Number 4 List Tests 5 Add New Tests Select Test ESC 1 HBSAG M RUN SEL 2 TSH S PRNT 3 HCV A NXT 4 MUL_4P M PREV 5 CP_560 C DEL PLATE DATA UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 59 of 117 Details of absorbance of all wells in table format for each strip will be displayed on the screen as shown below In this operation if you keep BLANK YES The first well of first strip will be considered as blank and instrument will give the absorbance of remaining all well with blank subtraction from original absorbance The PRINT MATRIX will print the details of entire plate with well identification and absorbance of that well like A W1 W2 W3 W4 W5 W6 0 125 0 250 0 350 0 450 0 550 0 650 Using SEND PLATE plate data can be sen
91. t is not possible to change this combination In PRINT MATRIX you will get the print of entire plate data with actual absorbance of each well and difference of absorbance between ODD well and EVEN well like A W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 0 300 0 279 0 524 0 497 0 816 0 499 0 082 0 474 0 651 0 331 0 394 0 562 0 000 0 021 0 000 0 028 0 000 0 316 0 000 0 391 0 000 0 320 0 000 0 168 B W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 0 506 0 584 0 648 0 194 0 472 0 457 0 822 0 346 0 679 0 387 1 047 0 130 0 000 0 077 0 000 0 453 0 000 0 015 0 000 0 476 0 000 0 292 0 000 0 918 Name ABS DIFF ABSORBANCE Pri 560 Sec 0 ABS ABS ABS ABS ABS ABS 1 2 3 4 5 6 0 900 1 700 0 900 0 200 1 000 1 800 0 300 1 100 1 900 0 400 1 200 2 000 0 500 1 300 2 100 0 600 1 400 2 200 0 700 1 500 2 300 0 800 1 600 2 400 ABS ABS ABS ABS ABS ABS 7 8 9 10 11 12 0 100 0 900 1 700 0 200 1 000 1 800 0 300 1 100 1 900 0 400 1 200 2 000 0 500 1 300 2 100 0 600 1 400 2 200 0 700 1 500 2 300 0 800 1 600 2 400 ESC PRINTMATRIX SEND PLATE LOAD NEXT UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 62 of 117 9 2 Cut off Mode After recalling the test saved in Cut Off mode it will display following screen User can take the print of the test parameters by selecting PRNT
92. t to computer using either USB or SERIAL RS232 LOAD NEXT is used to load the Next Plate in order to get the absorbance of next plate Name HCV NORM ABSORBANCE Pri 450 Sec 560 BL N ABS ABS ABS ABS ABS ABS 1 2 3 4 5 6 0 028 0 145 0 100 0 017 0 089 0 135 0 071 0 123 0 113 0 054 0 116 0 060 ABS ABS ABS ABS ABS ABS 7 8 9 10 11 12 0 362 0 078 0 410 1 440 0 746 0 224 0 112 0 111 0 093 2 568 0 396 0 015 ESC PRINTMATRIX SEND PLATE LOAD NEXT UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 60 of 117 Example Print out of ABSORBANCE test obtained from ELISA Reader After running the plate in Absorbance mode user can take the print of the result in the form of Print matrix which will be printed as follows UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 61 of 117 Differential Absorbance Mode In differential absorbance mode the instrument will give the absorbance difference each set of ODD number strip and EVEN number strip It is showing the absorbance only for even number strips This absorbance values are actually differences between each well of strip 1 and well of strip 2 You can get the difference between set of 1 2 3 4 5 6 7 8 9 10 and 11 12 I
93. te loaded YES NO Name HCV POS Cut Off Pri 560 Sec 0 ESC No of Samples 10 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B S3 NC S4 NC S5 NC S6 PC S7 PC S8 S1 S9 S2 S10 Name HCV POS Cut Off Pri 560 Sec 0 ESC No of Samples 10 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B S3 NC S4 NC S5 NC S6 PC S7 PC S8 S1 S9 S2 S10 Is Plate Loaded YES NO Name HCV POS Cut Off Pri 560 Sec 0 ESC No of Samples 0 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B NC NC NC PC PC Numeric Value 10 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 64 of 117 D Here the plate is loaded in the direction that controls should go in first Select YES The instrument will read the controls and samples Following message appears Is plate removed YES NO Remove the plate and select YES E After selecting YES result screen will appear with the measured values of average blank average of all controls and the cut off absorbance To check the results of samples select option Display value Name HCV POS Cut Off Pri 560 Sec 0 ESC No of Samples 10 RUN DUP N SIMUL PID 1 2 3 4 5 6 7 8 9 10 11 12 B S3 NC S4 NC S5 NC S6 PC S7 PC S8 S1 S9
94. the particular test In this way user can directly run the selected test by just entering the valid test no Select Test ESC 1 HBSAg S 2 HCVAb M RUN SEL 3 UPT U 4 TSH M PRNT 5 CPC C 6 PER_ABS P NEXT 7 CRP C 8 KIN_405 K PREV 9 SIN_630 S 10 CP_560 C DEL PLATE DATA MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial Communication TEST OPERATIONS 1 Select Test By Name ESC 2 Select Test By Mode 3 Select Test By Number 4 List Tests 5 Add New Test Select Test ESC 1 HBSAg S 2 HCVAb M RUN SEL 3 UPT U 4 TSH M PRNT 5 CPC C 6 PER_ABS P NEXT 7 ABS A 8 KIN_405 K PREV 9 SIN_630 S 10 CP_560 C DEL Numeric Value 7 1 2 3 4 5 6 ENTER 7 8 9 0 CLEAR Name ABS NORM ABSORBANCE Pri 450 Sec 560 BL N ABS ABS ABS ABS ABS ABS 1 2 3 4 5 6 ABS ABS ABS ABS ABS ABS 7 8 9 10 11 12 Is Plate Loaded YES NO UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 17 of 117 6 INSTALLATION PROCEDURE AND VERIFICATION CRITERIA 6 1 Unpacking Instructions Check accessories as per packing list Kindly store all packaging materials so as to use it to repack and ship for maintenance or servicing 6 2 Placing the Instrument The instrument has to be placed on a level bench Room temperature has to be between 10 to 35 C with a relative humidity below
95. tion to these sensor and also the connection of stepper motor which is used to move plate carrier UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 115 of 117 19 DECONTAMINATION 19 1 Decontamination Procedure If the instrument is to be shipped after being exposed to potentially hazardous material it should be decontaminated The following procedure outlines the method of decontaminating the instrument before packaging and shipment 19 2 Purpose of Decontamination Decontamination minimizes the risk to all who come in contact with the instrument during shipping handling and servicing 19 3 General Considerations Any laboratory instrument that has been used for clinical analysis is considered a biohazard and should be decontaminated prior to handling Intact skin is generally considered an effective barrier against infectious Organisms however small abrasions and cuts may not be always being visible Prophylactic gloves must be worn when handling instruments that have not been decontaminated Gloved hands should be considered contaminated at all times and must be kept away from eyes mouth and nose at all times Mucous membranes are considered prime entry routes for infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols Eating and drinking while decontaminating instruments is not advisable 19 4
96. tly RUN the test by selecting RUN option present on the screen KINETIC Name KIN_560 ESC Pri 560 Sec 0 SAVE Read Time 1 min Read Period 15 sec Select Test ESC 1 HBSAG RUN SEL 2 TSH PRNT 3 HCV NXT 4 MUL_4P PREV 5 CP_560 DEL PLATE DATA MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial Communication TEST OPERATIONS 1 Select Test By Name ESC 2 Select Test by Mode 3 Select Test by Number 4 List Tests 5 Add New Tests TEST OPERATIONS 1 Select Test By Name ESC 2 Select Test By Mode 3 Select Test By Number 4 List Tests 5 Add New Tests UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 58 of 117 Tests can be selected with the help of SEL option present on the Select Test screen in order to EDIT PRINT the test parameters entered before saving the test 9 1 Absorbance Mode Select the test and point to RUN option On selecting RUN option it will display following screen The instrument will ask Is Plate Loaded YES NO select Yes Instrument will read the absorbance using mechanical plate movement After completion of reading it will ask Is Plate Removed YES NO Remove the plate and Select YES NORM ABSORBANCE Name HCV BL N ESC Pri 450 Sec 560 EDIT NORM RUN MODE DIFF PRINT Select Tes
97. u select this option the lamps will turn ON tray holder plate will comes out and the instrument will start showing amplitudes gains of all filters one by one TECHNICAL DIAGNOSIS ESC 1 Clear Memory 2 Lamp Amplitude 3 Printer Self test 4 Lamp Centering Check LAMP AMPLITUDE ESC 1 Stability Check 2 Filter Amplitude UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI number 1701327 Page 111 of 117 1 Stability Check 2 Filter Amplitude LAMP AMPLITUDE ESC 1 Stability Check 2 Filter Amplitude Filter 405 ESC CH1 CH2 CH3 CH4 1921 8 2011 7 1983 7 1875 2 1920 4 2010 3 1982 4 1874 2 1919 4 2009 3 1981 7 1873 4 1918 5 2008 5 1981 2 1872 9 1918 0 2007 8 1980 8 1872 5 CH5 CH6 CH7 CH8 1921 0 1868 4 1899 1 1848 0 1919 9 1867 3 1898 1 1846 6 1919 2 1866 5 1897 4 1845 8 1918 7 1866 0 1896 9 1844 9 Displays the Lamp Amplitude of all the filters LAMP AMPLITUDE ESC 1 Stability Check 2 Filter Amplitude LAMP AMPLITUDE ESC 1 Stability Check 2 Filter Amplitude Select Filter Val 0 405 450 492 630 NA NA 560 YYY Filter 560 ESC CH1 CH2 CH3 CH4 1997 6 1869 1 2042 2 2014 2 1997 5 1868 9 2042 3 2014 3 1997 2 1868 9 2042 3 2014 5 1997 1 1868 9 2042 5 2014 6 1997 0 1868 7
98. ve the plate and select YES The plate holder will go inside and following screen will be flashed on the display Note It takes maximum 6 min only in case of 4 parameter After reading it will display all the details of calibrators samples and controls on the screen as shown below All the details as per row and column are shown on the screen The printout of the same format can be obtained by selecting PRINT RESULTS To check the results of next samples select NXT and print the format shown on screen by option Print Results Name TSH MULTI STANDARD ESC Pri 450 Sec 560 BL Y CAL 7 DUP N DUP N Range High gt 15 25 Low lt 9 46 NXT HI CO High gt 25 03 Low lt 10 54 LO CO High gt 16 61 Low lt 5 45 PREV NO SAMP ABS AVG CONC REM PID A1 B 0 050 0 050 SAVE B1 C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 G1 S1 0 200 0 200 2 100 NEG TSH 1 H1 S2 1 854 1 854 9 845 POS TSH 2 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS Name MULTI STANDARD ESC Pri Sec BL CAL NXT DUP DUP PREV Range High gt Low lt HI CO High gt Low lt SAVE LO CO High gt Low lt RESULT NO SAMP ABS AVG CONC REM PID Please Wait It may take maximum 6 minutes LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS UUsseerr M Maannuuaall EELLIISSAA PPLLAATTEE RREEAADDEERR Version 150511 PI nu

ELISA PLATE READER - DIAsource Immunoassays

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