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User Manual RWT _ver RBK_3.400A_

1. TEST OPERATIONS 1 Select Test By Name 2 Select Test By Mode 3 Select Test By Number 4 List Tests 5 Add New Test B Select mode of operation Cut Off in Add New Test Select Test Mode 1 gt Absorbance 2 gt Single Standard 3 gt Cut off 4 gt Multi Standard 5 gt Percent Absorbance 6 gt Uptake 7 gt Kinetic Version No RBK 3 4004 Effective Date Nov 2012 Page 28 of 121 User Manual C Entry of test name Select touch Zone Name Name POS CutOff Pri 405 Sec 0 No Factor QC QCVal Mes Rem BL NC 1 000 PC 1 000 LC 1 000 CC 0 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 readwell TOUCH 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 POS CutOff HBSAG E M Version No RBK 3 400A Effective Date Nov 2012 User Manual readwell TOUCH D Selection of Primary and secondary filters Select zone Pri on the touch screen Name HBSAG POS CutOff Pri 405 Sec 0 No Factor QC QCVal Mes Rem BL NC 1 000 PC 1 000 Select Filter Val LC 1 000 0 405 450 CC 0 1 000 492 630 NA CUTFAC 0 000 NA XXX YYY SUUTAS Select the requir
2. lt gt Lens Wells Nh Lens lt i pp Filter Analogue to Digital Key Pad Touch Panel Printer RS232 USB Display Converter Amplifier Version No RBK 3 4004 Effective Date Nov 2012 Page 13 of 121 User Manual 5 2 Perspective View 5 2 1 Front View 5 2 2 Rear View Serial RS232 O P readwell TOUCH Ext Printer connection T Version No RBK 3 400A Effective Date Nov 2012 Cooling Fan On Off switch USB output SMPS Page 14 of 121 User Manual readwell TOUCH 1 Contrast Knob use to adjust display contrast 2 Serial RS232 output 3 Cooling Fan 4 USB output 5 ON OFF switch 6 SMPS 7 External printer connection 5 3 Keypad ba Fu afi p 3030NiK ki Aa 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 FEED 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 HOME key is used for directly accessing the shaking mode ie SHAKER refer 15 5 for more details on SHAKER Note Functions based on HO
3. 15 10 4 LOGOUT Password Utility Password Utility 1 Enable Disable 1 Enable Disable 2 Set Password 2 Set Password 3 LOGIN 3 LOGIN 4 LOGOUT 4 LOGOUT Logout To Logout disable user select LOGOUT option present on the screen Version No RBK 3 400A Effective Date Nov 2012 Page 107 of 121 User Manual readwell TOUCH 16 SERIAL COMMUNICATION The instrument is equipped with an RS232 serial port for PC configuration ie User computer interface A cable is available to link the instrument to PC RS232 DB9 EIA TIA 574 Communication will only start when both ends detect the presence of an active terminal or device RS232 port settings in a windows Operating system PORT SETTINGS Bits per second 9600 Data Bits 8 Parity None None Stop Bits 1 Flow control None 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 MAIN MENU 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial communications Version No RBK 3 4004 Effective Date Nov 2012 Page 108 of 121 User Manual readwell TOUCH 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 Sen
4. C4 C5 C6 C7 HI CO 2 COL ROW 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 0 No of samples 10 DUP N SIMUL 1 2 3 4 5 6 B HC S5 C1 HC S6 C2 LC S7 C3 LC S8 C4 Si S9 C5 S2 C6 S3 C7 S4 HI CO 2 COL ROW Version No RBK 3 400A Effective Date Nov 2012 Page 73 of 121 User Manual readwell TOUCH 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 Remove 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 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 After reading it will display all the details of calibrators samples and controls on the screen as
5. Graph LINEAR Y vs X ABS vs CONC Version No RBK 3 400A Effective Date Nov 2012 Page 51 of 121 User Manual readwell TOUCH 1 LINEAR Mode graph type After Selecting the Graph option present in the test parameter screen it will display following screen Select Graph type as Linear and its Scale type as per the details given in the reagent manual Graph LINEAR Y vs X ABS vs LOGCONC TYPE SCALE LINEAR LOGABS vs CONC ABS vs LOGCONC PTTOPT LOGITABS vs LOGCONC ABS vs CONC 4 PARAMETER LOGABS vs LOGCONC 2 POINT TO POINT Graph Type Select touch zone PT to PT and its scale type as LOGABS vs CONC as per the details given in the reagent manual Graph Type PT TO PT Y vs X ABS vs CONC TYPE SCALE LINEAR LOGABS vs CONC ABS vs LOGCONC PT TOPT LOGITABS vs LOGCONC ABS vs CONG 4 PARAMETER LOGABS vs LOGCONC Version No RBK 3 400A Effective Date Nov 2012 Page 52 of 121 User Manual readwell TOUCH 3 4 PARAMETER Graph Type Select touch zone 4 PARAMETER and it will automatically selects it s default scale type as ABS vs CONC User have to remember this regarding 4 Parameter mode Graph Type 4 PARAMETER Y vs X ABS vs CONC TYPE SCALE LINEAR LOGABS vs CONC ABS vs LOGCONC PTTOPT LOGITABS vs LOGCONC ABS vs CONC 4 PARAMETER LOGABS vs LOGCONC Select the scale type touching the required zone Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC D
6. 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 At B 0 050 0 050 SAVE Bi Ci 0 070 0 070 0 000 RESULT C2 0 257 0 257 2 500 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS Version No RBK 3 400A Effective Date Nov 2012 Page 93 of 121 User Manual readwell TOUCH If PLATE OPT is selected you will obtain two options 1 SAVEPLATE DATA 2 SEND PLATE DATA 1 SAVE PLATE DATA it helps the user to save the entire plate information along with the control calibrator information maximum 10 plate 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 be saved SAVE RESULTS option is used to save the details related to samples Version No RBK 3 4004 Effective Date Nov 2012 Page 94 of 121 User Manual readwell TOUCH 14 VIEW STORED DATA The stored plate or stored results appear on the screen by selecting option View Plate in MAIN MENU MAIN MENU 1 Test Operations 1 PLATE RESULTS 2 Technical Diagnosis 2 PATIENT RESULTS 3 Utilities 4 View Plate 5 Serial Communication 14 1 PLATE RESUL
7. 2012 Page 22 of 121 User Manual readwell TOUCH Pipetting sequence should be as shown below KEKKEI A IS a at HO e A 13 Js el rr cir za y 00 yi IA od AS 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 and reagents reagent and control expiry dates need to be checked Version No RBK 3 400A Effective Date Nov 2012 Page 23 of 121 User Manual readwell TOUCH 7 PRECAUTIONS EA 1 Do not use any sharp objects on the Touch Screen Always use the STYLUS provided to operate the touch panel 2 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 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 refer
8. TEC61326 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 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 Version No RBK 3 400A Effective Date Nov 2012 Page 7 of 121 User Manual readwell TOUCH 3 INTRODUCTION 3 1 Description read well TOUCH 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 for in vitro diagnostic use 3 2 Special Features The readwell TOUCH 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 itself 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 readwell TOUCH operates on a WIDE voltage 90 270 volt This eliminates the need for an external voltage stabilizer The readwell TOUCH has a special provision which al
9. 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 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 Instrument 1 MAIN MENU SERIAL COMM 1 Send Results 2 Send Test Records 1 Test Operations 2 Technical Diagnosis 9 3 Receive Test Records 3 Utilities 4 View Plate Download Test Records YES NO 5 Serial communications ep Version No RBK 3 400A Effective Date Nov 2012 Page 112 of 121 User Manual readwell TOUCH Now for Sending Test Records switch on to Instrument 2 Instrument 2 MAIN MENU SERIAL COMM 1 Send Results 2 Send Test Records 3 Receive Test Records 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 View Plate Send Test Records WES 0 NO eee a 5 Serial COMMUNICATIONS erre Select YES in order to send all the test records SERIAL COMM 1 Send Results 2 Send Test Records 3 Receive Test Records Sending And similarly Instrument 1 will display
10. 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 Version No RBK 3 400A Effective Date Nov 2012 Page 33 of 121 User Manual readwell TOUCH 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 No of PC s 2 Values Of Y 1 000 Value of PC gt 0 500 Numeric Value 12 3 4 5 6 ENTER 7890 CLEAR N After entering the details of PCs escape from the screen by selecting ESC option Below screen will appear on the display Name HBSAG POS CutOff Pri 450 Sec 630 ESC No Factor QCVal Mes Rem SAVE BL 0 100 NC 1 000 0 150 PC 1 000 0 500 LC 1 000 CC 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 NOTE Same way you can enter values for LC lower positive controls and CC Cut of Controls Version No RBK 3 4004 Effective Date Nov 2012 Page 4 of 121 User Manual readwell TOUCH O Entry of CUT OFF FACTOR Select touch Zone CUT FAC in order to enter the value for Cut Off Factor Name HBSAG POS CutOff Pri 450 Sec 630 ESC No Factor Q
11. 0 232 0 028 0 004 0 004 0 002 0 002 0 008 0 008 0 020 0 017 0 003 0 005 0 008 B wi w2 w3 wA w5 W6 W7 w8 w9 w10 w11 W12 0 139 2 577 1 502 1 511 1493 0861 0 793 0 832 0 805 0 233 0 813 0 226 0 061 0 004 0 002 0 020 0 026 0 023 0 011 0 012 0 030 0 004 0 022 0 015 C wi w2 w3 w4 WS5 W6 W 7 ws wa w10 w11 W12 0 502 2 700 0 168 0 878 0 278 0 523 0 236 0 252 2 592 0 867 0 963 2 720 0 042 0 001 0 004 0 011 0 014 0 014 0 029 0 037 0 005 0 030 0 009 0 018 D wi w2 w3 w4 ws5 W6 W7 ws ws w10 wi W12 0 536 2 730 0 196 0 897 0 260 0 897 0 257 0 255 2 720 0 907 0 912 2 698 0 015 0 014 0 027 0 013 0 035 0 043 0 027 0 012 0 000 0 030 0 004 0 016 E wi W2 w3 w4 w5 W6 W7 ws ws w10 w11 W12 0 936 1 608 0 264 0 938 0 282 2 711 0 635 0 556 0 568 2462 1 655 1 542 0 036 0 024 0 021 0 027 0 005 0 008 0 006 0 005 0 009 0 021 0 007 0 014 F wi w2 w3 w4 ws W6 W7 ws wa wio wi w12 1 009 1 706 0 289 1 132 0313 1 707 0 568 0 554 0 604 3 155 1 682 1 647 0 078 0 055 0 057 0 055 0 044 0 077 0 067 0 040 0 040 0 012 0 036 0 054 G wi W2 w3 w4 w5 w6 W7 w8 w9 w10 wi W12 1 559 1 565 1448 1 485 0 225 1 523 0 239 2547 2 715 1490 1 542 1 532 0 027 0 021 0 026 0 027 0 022 0 022 0 027 0 054 0 013 0 033 0 031 0 012 wi W2 w3 w4 w5 W6 W7 ws w9 w10 wi W12 1 618 1 595 1 581 1 615 0 250 2 646 0 274 2 564 2 616 1 598 1 576 1 613 0 050 0 031 0 047 0 018 0 037 0 017 0 079 0 007 0 020 0 050 0 022 0 003 Note Same Procedure can be used to create and run the test in all other modes
12. 099 0 737 1 122 3201 0636 3533 1284 6564 1 959 is POS NEG NEG NEG POS POS NEG POS POS POS POS wi we w3 we ws w w7 wa wa wo wn w12 NC s5 513 21 29 S37 S45 553 561 s569 577 sas OPD14 OPD22 OPD30 OPD38 OPD46 OPDS4 OPD62 OPD70 OPD78 OPD86 OPDM 0062 0 145 0382 2535 0 116 1 470 2573 0 115 2515 0 747 0 748 0 003 0 000 1 278 3372 2239 1 024 1299 22 73 1011 2222 6597 6608 0 025 POS POS POS EQ POS POS EQ POS POS POS NEG e wi w2 w3 wa w5 w w7 wa ws w10 wi wiz NC s6 14 22 30 38 S46 54 62 70 578 86 OPD15 OPD23 OPD31 OPD39 OPD47 OPDS5 OPD63 OPD71 OPD79 OPD87 OPDIS 0 040 2 573 0 129 0 159 0 133 0 217 0 077 0 091 1 584 1 557 0502 2638 0000 2272 1135 1405 1 177 1 917 0 677 0804 1399 1375 4434 2330 E POS POS POS POS POS NEG NEG POS POS POS POS wi w2 w3 was ws w w7 wa ws wio wi w12 PC 57 15 23 31 39 547 555 563 71 579 S87 OPD16 OPD24 OPD32 OPD40 OPD4B OPDS6 OPD64 OPD72 OPDSO OPD88 OPDSE 0 080 0 157 2630 0 141 2642 0 058 0 155 0 159 1 515 0 071 0423 0 209 0 000 1389 2323 1246 2333 0 516 1 370 1403 1338 0628 3732 1 850 R POS POS POS POS NEG POS POS POS NEG POS POS wi w2 ws wa ws we w7 wa wa w10 wi wiz PC ss 16 24 32 S40 S48 S56 S64 72 80 sas OPD17 OPD25 OPD33 OPD41 OPD49 OPDS7 OPD65 OPD73 OPDA1 OPD89 OPD 7 2562 0 172 0198 0061 0 182 0 165 2656 0 156 0 080 2616 0259 0224 0 000 1517 1751 0536 1612 1457 2346 1377 0 705 23 11 2291 1 978 5 POS POS NEG POS POS POS POS NEG POS POS POS wi w2 w3 ws w5 we W7 wa ws W10 wi wiz si s9 17 s25 33 S41 54
13. 100 Absorbance NC 1 000 0 150 When you select Cutoff Index PC 1 000 0 500 LC 1 000 CC 1 000 become NO means inactive CUTFAC 0 200 In Cutoff Index provide the CUTABS NC PC CF Sample Absorbance Cut off Y the Greyzone will range for interpretation the QC1 gt Y 0 500 Interpretation Qc2 Greyzone N positive and negative value of QC3 Cut off Index Y ratio Sample Abs Cutoff Abs QC4 Range Pos 0 000 Neg 0 000 RESULT RANGE POSITIVE gt 1 000 RESULT RANGE POSITIVE gt 0 000 NEGATIVE lt 0 000 EEN lt 0 000 Numeric Value 4 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 Version No RBK 3 4004 Effective Date Nov 2012 Page 42 of 121 User Manual After entering the Interpretation values ie conditions for interpretation the screen will be displayed as follows Name HBSAG Pri 450 Sec 630 No Factor BL 1 NC 3 PC 2 LC 0 1 000 1 000 1 000 1 000 CUTFAC 0 200 CUTABS NC PC CF QC1 gt Y 0 500 QC2 QC
14. 180 2 326 7 PID VSR1 VSR2 VSR3 VSR4 NRA1 NRA2 NRA3 NRA4 ESC NEXT PREV PRINT Version No RBK 3 400A Effective Date Nov 2012 Remarks EQ POS NEG POS EQ NEG NEG POS Page 97 of 121 User Manual readwell TOUCH 15 UTILITIES UTILITIES consists of 10 different functions which can be viewed as follows UTILITIES Version 3 4004 1 Date and Time ESC 2 Program Filter 2 Technical Diagnosis 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 4 View Plate 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password MAIN MENU 1 Test Operations 3 Utilities 5 Serial Communication 15 1 Date amp Time Setting This Utility helps the user to set current Date and Time UTILITIES Version 3 4004 1 Date and Time 2 Program Filter 3 Printer On Off ON 01 01 08 4 Enter Clinic Name 5 Shaker Date DD MM YY Time Hrs Min Sec 12 30 10 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password Version No RBK 3 4004 Effective Date Nov 2012 Page 98 of 121 User Manual readwell TOUCH 15 2 Program Filter It consists of two editable filters and thus helps the user to edit the filters if any UTILITIES Version 3 4004 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker Numeric Value 405 6 Communication Settings USB 1 2 3 4 5
15. 6 7 8 9 O Is Plate Loaded Version No RBK 3 400A Effective Date Nov 2012 Page 17 of 121 User Manual readwell TOUCH 6 INSTALLATION PROCEDURE amp 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 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 di Please make sure that electrical power source is properly grounded 6 5 Printer READWELL TOUCH an ELISA Analyser is eguipped 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 LEVER Version No RBK 3 400A Effective Date Nov 2012 Page 18 of 121 User Manual readwell TOUCH Closing the Paper Cover replacement of paper roller Open the Paper Flap Remove the paper roller from the slot Now place the Thermal side of the paper roll at the top into the slot provided and then close
16. 6 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 10 Password Edit Filters YES NO XXX 405 YYY Numeric Value 690 1 2 15 3 Printer On Off setting Its a toggle between Printer ON and Printer OFF 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 Version No RBK 3 400A Effective Date Nov 2012 Page 99 of 121 User Manual 15 4 Enter Clinic Name readwell TOUCH Enter your Clinic Name and select ENTER The character length is maximum 19 characters UTILITIES Version 3 4004 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 15 5 Shaker Plate Shaking Mode UTILITIES Version 3 400A CLINIC MEDICARE ABC DE F G J K LEM N O QRs T U V W YZ _ 1 Shaker is used for shaking the plate before running any test The Shaker screen is displayed as follows UTILITIES Version 3 4004 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 Version No RBK 3 400A Effective Date Nov 2012
17. Is plate removed YES NO Remove the plate and select YES Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 10 DUPN SIMUL 1 2 3 4 5 B S83 NC S4 NC S5 NC S6 PC S7 PC S8 S1 S9 S2 S10 Is Plate Removed 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 450 Sec 0 ESC No Factor QCVal ACCEPT BL 1 0 100 TEST NC 2 1 000 0 150 PC 2 0 100 0 500 PRINT LC O 1 000 CC 0 1 000 CUTFAC 0 200 CUTABS 0 563 Display VALUE QC1 2 560 QC3 LOAD NEXT Range 10 00 Version No RBK 3 400A Effective Date Nov 2012 Page 66 of 121 User Manual readwell TOUCH F DISPLAY VALUE option will display the result of all samples along with the controls selected Name HCV POS Cut Off Pri 450 Sec 0 BL Y Range PERCENTAGE 10 00 Pos 0 330 CUT ABS 0 300 Neg 0 270 NO SAMP ABS AVG INDEX REM Ait B 0 050 0 050 Gi Si 0 200 0 200 0 254 NEG PQR 1 H1 2 1854 1 854 7 245 POS PQR 2 PRINT SAVE PRINT PLATE RESULTS RESULTS MATRIX OPT 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 c
18. Name Test Name can be entered by Selecting Touch Zone Name Procedure for entering the test name is same as that of the 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 Name MUL_4P MULTISTANDARD Pri 405 Sec 0 BLN CAL 2 ESC HICO 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 Filter Val 0 405 450 492 630 NA NA XXX YYY Select the Filters as per details given in the reagent manual Version No RBK 3 400A Effective Date Nov 2012 Page 46 of 121 User Manual readwell TOUCH E Selection of Blank Select Touch Zone BL Instrument will display the message Blank required Yes No at the bottom of the Screen select Yes if blank is required Name MUL_4P MULTISTANDARD Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLN CAL 2 ESC Pri 450 Sec 0 BLN CAL 2 DUPN DUP N DUP N HICO N High L HICO N High gt Low lt nd S LO CO N High gt Low lt LO CO N High gt Low lt Interpretn N Range High gt Interpretn N Range High gt Low lt Low lt Graph LINEAR Graph LINEAR Blank Required Y vs X ABS vs CONC F Entry of Standard Concentration Select touch Zone CAL to enter Number of calibrators and its concentration Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL2 ESC DUP N DUP N SAV
19. calibration will be displayed as follows Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC DUP N DUP N SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpretn N Range High gt Low lt Graph LINEAR 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 Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC Pri 450 Sec 0 BLY 0 000 CAL7 DUP N DUP N DUP N DUP N SAVE HICO N High gt Low lt HICO N High gt LOCO N High gt Low lt LO CO N High gt Interpret n N Range High gt Interpretn N Range Low lt Graph LINEAR Graph LINEAR Duplicate Blank Y vs X ABS vs CONC For Duplicate Calibrators Version No RBK 3 400A Effective Date Nov 2012 Page 49 of 121 User Manual readwell TOUCH 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 Name MUL_4P MULTISTANDARD Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC Pri 450 Sec 0 BL Y 0 000 CAL 7 ESC DUP Y DUP N DUP Y DUP N SAVE SAVE HI CO N High gt Low lt HI CO N High gt Low lt LO
20. delete the unwanted tests and save the test Using data receiving application on computer Version No RBK 3 400A Effective Date Nov 2012 Page 1180f 121 User Manual 5 Check USB Application on Computer Do you want to continue YES NO 6 Filter Movement Error OR Filter Index Error 7 Plate Movement Error OR Plate Index Error Version No RBK 3 400A Effective Date Nov 2012 readwell TOUCH 1 If you have not connected the data cable USB or Serial correctly you will get this message 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 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
21. plate data with actual In PRINT MATRIX you will get the 8 10 12 absorbance of each well and difference of 0 100 0 900 1 700 0 200 1 000 1 800 l 0 300 1 100 1 900 EVEN well like absorbance between ODD well and 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 PRINTMATRIX SEND PLATE LOAD NEXT Wi W2 W3 Ww w5 WE W7 W8 W9 Wio Wii 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 Wi W2 W3 W4 W5 W6 W7 ws 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 Version No RBK 3 400A Effective Date Nov 2012 Page 63 of 121 User Manual readwell TOUCH 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 PRINT option present on the screen It will print all the details of the test parameters alongwith QC equations Name HCV POS Cut Off Pri 450 Sec 0 Factor QCVal BL 0 100 NC 1 000 0 150 PC 1 000 0 500 LC 1 000 CC 1 000 CUTFAC 0 100 CUTABS 0 1 PC CF QC1 Interpretation QC2 Greyzone Y 10 00 QC3 Cut off Index N QC4 N Range To change values press EDIT A For rumning the test in CUTOFF mode select the particular test and point to RUN option pr
22. the following screen which denotes that the instrument is downloading the Test Records SERIAL COMM 1 Send Results 2 Send Test Records 3 Receive Test Records 1248 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 Records from instrument to instrument Version No RBK 3 4004 Effective Date Nov 2012 Page 113 of 121 User Manual readwell TOUCH 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 SERIAL COMM 1 Send Results 2 Send Test Records 3 Receive Test Records Invalid in USB communication Version No RBK 3 400A Effective Date Nov 2012 Page 114 of 121 User Manual readwell TOUCH 17 TECHNICAL DIAGNOSIS Technical Diagnosis is present in Main Menu MAIN MENU l TECHNICAL DIAGNOSIS 1 Test Operations 1 Clear Memory 2 Technical Diagnosis Ga 2 Lamp Amplitude 3 Utilities p 3 Printer Self test 4 View Plate de 4 Lamp Centering Check 5 Serial Communication 17 1 Clear Memory This option is used to clear entire saved Test Records and Patient Results along with saved plates The Test Records are the different kind of programmed test that are made in dif
23. 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 Version No RBK 3 400A Effective Date Nov 2012 Page 20 of 121 User Manual readwell TOUCH 6 7 Touch Panel Check READWELL TOUCH provides a Touch sensitive LCD panel and a KEYPAD for easy user interface The Menus are displayed and the text of the parameter forms the TOUCH ZONE Touch screen Layout Name POS CutOff Pri 405 Sec 0 No Factor QC QCVal Mes Rem BL NC 1 000 PC 1 000 LC 1 000 CC 0 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 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 a
24. 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 Version No RBK 3 400A Effective Date Nov 2012 Page 37 of 121 User Manual readwell TOUCH Q QC1 QC2 QC3 amp QCA can be used for any QC Checking of the test provided in reagent manual For example some kit may give QC check equation likel PCx NCx I gt 0 500 PC NC gt 15 etc This equation can be entered by selecting these QC options Select touch zone N It will change to Y as shown in the below screen Now select touch zone QC1 and enter QC equation Name HBSAG Pri 450 Sec 630 BL NC PC LC CC CUTFAC 0 200 CUTABS NC PC CF No Factor 0 1 000 1 000 1 000 1 000 QCi gt Y QC2 QC3 QC4 QC Version No RBK 3 400A Effective Date Nov 2012 POS CutOff ESC QCVal Mes Rem SAVE 0 100 0 150 0 500 Interpretation Greyzone N Cut off Index Y Range Pos 0 000 Neg 0 000 Page 38 of 121 User Manual readwell TOUCH Enter equation of QC and value of QC check by selecting touch zone QC1 Value amp QC1 equat Enter QC Value and Equation Enter QC Value and Equation QC1 Value 0 000 QC1 Value 0 500 QC1 Equat QC1 Equat Numeric Value 1 2 Enter QC Value and Equation QC1 Value 0 000 QC1 Equat QC Equa PC NC NC PC LC CC SA Sqrt Log ALog Ln Same way y
25. 021 1 Version No RBK 3 400A Effective Date Nov 2012 Page 110 of 121 User Manual readwell TOUCH 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 SERIAL COMM SERIAL COMM 1 Send Results 1 Send Results 2 Send Test Records ss set 2 Send Test Records 3 Receive Test Records 3 Receive Test Records Send Test Records YES NO Suppose by default if Serial Communication is set to USB then it will display following screen with msg string SERIAL COMM 1 Send Results 2 Send Test Records 3 Receive Test Records Invalid in USB communication Version No RBK 3 400A Effective Date Nov 2012 Page 111 of 121 User Manual readwell TOUCH 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 SERIAL COMM SERIAL COMM 1 Send Results 1 Send Results 2 Send Test Records 2 Send Test Records 3 Receive Test Records a seisus veraos anipe sanre 3 Receive Test Records Download Test Records YES NO Note 1 User must first restart the instrument before sending the data from one instrument to
26. 1 Instrument Working Principle Switch on and program the instrument Place the plate firmly onto the carriage 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 can be printed or user can save the plate data e Results are also available at the RS232 Serial Port USB Port On starting the test the plate will be conveyed into the instrument Plate is moved in step by step by a well controlled mechanism amp 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 for analyzing the measured value amp presenting the same on the printer display amp RS232 Serial Port USB 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 amp passes through the sample Part of the light is absorbed by the sample amp the remaining light is transmitted It is filtered by interference filters amp focused onto the photodiodes The photodiode converts the received light in to an electrical signal which is in turn transformed into digital form from which the microprocessor calculates the absorbance taking in account of the blank amp bichromatic selection Lamp K
27. 121 User Manual readwell TOUCH 8 8 Kinetic After entering Test Name and Filter values select Read Time and Read Period KINETIC KINETIC Name KIN Name KIN Pri 450 Sec 0 Pri 450 Sec 0 Read Time 1 min Read Time 1 min Read Period 15 sec Read Period 15 sec Numeric Value 1 2 KINETIC Read Time is total read period of the whole test Name KIN You need to enter it only in minutes Pri 450 Sec 0 Read Time 1 min Read Period 15 sec Numeric Value 1 2 Read Period is time interval between two readings User must enter it in seconds Finally select the Save option in order to save the test in KINETIC mode KINETIC Name KIN Pri 450 Sec 0 Read Time 1 min Read Period 15 sec Version No RBK 3 4004 Effective Date Nov 2012 Page 58 of 121 User Manual readwell TOUCH 9 RECALLING AND RUNNING OF STORED TEST PROGRAMS MAIN MENU TEST OPERATIONS 1 Test Operations 5 1 Select Test By Name 2 Technical Diagnosis 2 Select Test by Mode 3 Utilities 3 Select Test by Number 4 View Plate 4 List Tests 5 Serial Communication 5 Add New Tests 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 directly RUN the test by selecting RUN option present on the screen TEST OPERATIONS Select Test ESC 1 Select Test By Name 1 HBSAG RUN SEL 2 TSH PR
28. 269 150 00 1 850 200 00 2 000 ESC PRINT PLOT Version No RBK 3 4004 Effective Date Nov 2012 Page 86 of 121 User Manual readwell TOUCH The Graph screen will be displayed as shown below Origin at X 0 000 y 0 000 X div 2 500 y div 0 150 3 00 Version No RBK 3 4004 Effective Date Nov 2012 Page 87 of 121 User Manual readwell TOUCH 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 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 Name HCV POS Cut Off Name HCV POS Cut Off Pri 450 Sec 0 Pri 450 Sec 0 No of Samples 0 No of Samples 0 DUP N SIMUL DUP N SIMUL 12 3 4 5 6 1 2 3 4 5 B 12 NC NC B NC NC PC NC PC NC Numeric Value 10 1 2 PC Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 10 DUP N SIMUL 1 2 3 4 5 6 B S3 NC S4 NC S5 NC S6 PC S7 PC S8 S1 S9 S2 Version No RBK 3 400A Effective Date Nov 2012 Page 88 of 121 User Manual readwell TOUCH If you want to load duplicate samples select DUP option and then enter the number of samples by selecting No of Sa
29. 3 QC4 CC 0 POS CutOff ESC QCVal Mes Rem SAVE 0 100 0 150 0 500 Interpretation Greyzone N Cut off Index Y Range Pos 1 000 Neg 0 900 readwell TOUCH For example If you enter POS gt 1 0 and NEG lt 0 9 Then the sample POSITIVE remarks having INDEX Value Sam Abs Cutoff Abs gt 1 000 will get 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 S To save the test after entering all the parameters select SAVE option Name HBSAG Pri 450 Sec 630 No Factor BL 1 NC 3 PC 2 LC O 1 000 CC o 1 000 CUTFAC 0 200 CUTABS NC PC CF QC1 gt Y 0 500 QC2 QC3 QC4 1 000 1 000 Version No RBK 3 400A Effective Date Nov 2012 POS Cut Off QCVal Mes 0 100 0 150 0 500 Interpretation Greyzone Y 10 00 Cut off Index N Range Page 43 of 121 User Manual readwell TOUCH 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 Name REV CutOff Pri 405 Sec 0 ESC No Factor QCVal Mes Rem SAVE BL NC 1 000 PC 1 000 LC 1 000 CC 0 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone Y 10 00 QC3 Cut off Index N QC4 Range In Reverse Cut Off Mode programming of test i
30. 6 Graph 4 PARAMETER Y vs X ABS vs CONC Same way you can make a test for Single standard Absorbance and uptake Version No RBK 3 4004 Effective Date Nov 2012 Page 56 of 121 User Manual readwell TOUCH 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 Name ABSORBANCE Pri 405 Sec 0 BLY 0 000 CAL 1 DUP N DUP N HI CO N High gt Low lt LO CO N High gt Low lt Interpretn N Range High gt Low lt 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 Sample Absorbance Name UPTAKE Pri 405 Sec 0 BLN CAL 1 ESC DUP N DUP N SAVE Please refer 8 5 for HI CO N High gt Low lt parameter entry LO CO N High gt Low lt Interpretn N Range High gt Low lt Version No RBK 3 400A Effective Date Nov 2012 Page 57 of
31. 821 329 s37 345 553 561 So 57 885 POS Oris OP21 OP29 0 860 2 609 0 0982 0 804 0 183 0 600 0 158 0 157 2615 0 809 0 803 2 589 170 00 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 E wi wa ws we ws we w7 wa wa w109 wi wi2 c5 se S14 S22 30 838 S46 854 862 s7o 578 Sos oOPOG OP14 OP22 OP30 0 470 1 520 0 155 0 5646 0 154 2616 0 531 0 454 0 448 2 388 1 542 1431 510 00 4 772 0 532 2 600 0 532 7 579 1 547 1487 1 539 11 15 4 738 4 306 EQ NEG NEG NEG POS NEG NEG NEG POS EQ EQ F wr wa wa ws wo wr we we wo wit wiz c6 s7 S15 23 31 339 547 555 563 571 579 587 oro7 OP 1S OP23 1 54 0 161 0 824 0 162 1513 0 363 0 393 0 440 3 096 1 549 1 407 1700 00 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 G wi we wa wa ws we w7 wa wa wio wr wiz cr se s16 S24 332 s40 548 s 564 872 s80 Ses oPoa OP16 OP24 0 100 1 490 1419 1410 0 149 1456 0 159 2 447 2 637 1 416 1 454 1 453 3400 00 4478 4 337 4 393 0 520 7 114 0 510 9 689 10 24 4 293 4 376 4 442 A eo EQ EQ NEG POS NEG POS POS Eo Ea EG wi wa ws we ws ws w7 we wes wio wit wiz s so 517 825 833 S41 849 57 Sus 573 Sat 589 oPO oOPOS OPI op2s 1 539 1 498 1478 1 524 0 161 2 520 0 146 2 480 2 503 1 453 1 468 1 511 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 009 Version No RBK 3 4004 Effective Date Nov 2012 Page 76 of 121 User Manual readwell TOUCH G On selecting View Graph it displays the Graph screen with all the details of X axis and Y axis Sel
32. 9 857 S65 73 81 589 OPD10 OPD18 OPD26 OPD34 OPD42 OPD50 OPD5B OPDBB OPD74 OPD82 OPDIO OPDIE 2626 2612 0 055 0 116 2649 0 188 0 176 0 052 2638 0 855 0899 0419 2319 2307 0483 1 023 2340 1660 1 553 0460 2330 7548 7942 3699 POS POS NEG EQ POS POS POS NEG POS POS POS POS G wi w2 ws wa ws w WT wa wa wo wii wiz s2 sio sia 26 S34 S42 50 S58 S66 S74 82 s90 OPD11 OPD19 OPD27 OPD35 OPD43 OPD51 OPD59 OPD67 OPD75 OPD83 OPD91 OPD 0049 0140 2595 0 138 0 142 0 117 2 61 0076 0 081 0 050 0403 2579 0429 1234 2292 1215 1252 1 035 2306 0 672 0 717 0441 3564 2278 NEG POS POS POS POS EQ POS NEG NEG NEG POS POS H wi w2 ws wa ws w w7 wa wa w10 wi wiz s3 su 19 27 35 543 51 S59 S67 575 83 s91 OPD12 OPD20 OPD28 OPD36 OPD44 OPDS2 OPD60 OPD68 OPD76 OPD OPDI2 OPD100 0 061 0 109 0002 0 071 0 076 0 131 0 109 0 101 0 082 2560 0399 0015 0 538 0 964 0018 0631 0 670 1 157 0 960 1 896 0 721 2261 3527 0132 NEG EQ NEG NEG NEG POS EQ NEG NEG POS POS NEG Version No RBK 3 400A Effective Date Nov 2012 Page 68 of 121 User Manual readwell TOUCH 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
33. CAL1 2 562 CAL 2 2 259 CAL 3 2 050 CAL 4 1 054 CAL 5 0 648 CAL 6 0 356 CAL 7 0 045 Numeric Value 2 250 1 2 3 4 5 Version No RBK 3 400A Effective Date Nov 2012 Page 78 of 121 User Manual readwell TOUCH You can easily select any particular calibrator by touching the particular touch zone and edit the absorbance of that After editing the calibrator s absorbance select ESC A message will appear PLEASE WAIT and then 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 KINETIC Name KIN Pri 450 Sec 0 Read Time Read Period 15 sec Or else you can directly run the test from the List Test screen by selecting RUN option present on the screen Select Test ESC 1 HBSAg HCVAb UPT TSH CPC PER_ABS RUN SEL PRINT NEXT CRP KIN SIN 0 CP PREV sO ONOaARWD OVOXAOVTOZCZO DEL PLATE DATA Version No RBK 3 4004 Effective Date Nov 2012 Page 79 of 121 User Manual readwell TOUCH The D M means delta per minute of reaction When test will over instrument will show you the D M values of reaction done in each well Name KIN KINETIC Name KIN KINETIC Pri 450 Sec 0 Pri 450 Sec 0 D M D M D M D M D M D M D M D M D M D M 4 5 4 5 parla gaged Is Plate Removed It
34. CO N High gt Low lt LO CO N High gt Low lt Interpretn N Range High gt Interpret n N Range High gt Low lt Low lt Graph LINEAR Graph LINEAR Y vs X ABS vs CONC Duplicate Calibrator Screen after standard entry amp selection of duplicate Blank amp Calibrators Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC DUP Y DUP Y SAVE HICO N High gt LO CO N High gt Interpret n N Range Graph LINEAR Y vs X ABS vs CONC Version No RBK 3 400A Effective Date Nov 2012 Page 50 of 121 User Manual readwell TOUCH 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 Parameter 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 450 Sec 0 BLY 0 000 CAL7 ESC DUP Y DUP Y SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpretn N Range High gt Low lt
35. CVal Mes Rem SAVE BL 1 0 100 NC 3 1 000 0 150 PC 2 1 000 0 500 LC O 1 000 CC 0 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 After selecting the CUTFAC it will display following screen Value of Cut Factor 0 000 Value of Cut Factor 0 200 Numeric Value 123 4 5 6 ENTER 7 890 CLEAR Enter the Value for Cut Off Factor and select ESC option to come out to the test parameter screen Version No RBK 3 400A Effective Date Nov 2012 Page 35 of 121 User Manual readwell TOUCH P Entry of Cut off absorbance equation Select touch Zone CUTABS Name HBSAG POS CutOff Pri 450 Sec 630 ESC No Factor QCVal Mes Rem SAVE BL 0 100 NC 1 000 0 150 PC 1 000 0 500 LC 1 000 CC 1 000 CUTFAC 0 200 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 After selecting the CUTABS below screen will come on the display CUTABS CUT ABS NC PC CF CUTABS LC 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 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 Factor
36. E HICO N High gt LO CO N High gt Interpret n N Range Graph LINEAR Y vs X ABS vs CONC Version No RBK 3 4004 Effective Date Nov 2012 Page 47 of 121 User Manual readwell TOUCH After selecting CAL 1t 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 Whereas in case of 4 Parameter user can select min 5 and max 12 calibrators No Of Calibrator 2 No Of Calibrator 2 No Conc Abs No Conc Abs 1 0 000 0 000 1 0 000 0 000 0 000 0 000 0 000 0 000 Numeric Value 1 2 Concentration Entry After entering the number of calibrators concentration and absorbance column will come on the display 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 1 The concentration values should be either in ascending or descending order No Of Calibrator 7 No Conc Abs No Conc Abs 0 000 0 000 7 10 00 0 000 0 500 0 000 1 000 0 000 2 500 0 000 5 000 0 000 7 500 0 000 Numeric Value 1 Version No RBK 3 400A Effective Date Nov 2012 Page 48 of 121 User Manual readwell TOUCH Screen after entry of
37. Effective Date Nov 2012 Page 6 of 121 User Manual readwell TOUCH 2 2 Use of the Instrument The instrument has to be used for the designed purposes under specified conditions following proper procedures and safety rules by qualified personnel Ea 2 This manual contains instructions for operation performed by qualified personnel A gualified user has to make sure that environmental condition is suitable the installation 1s 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 Maintain room temperature and humidity as specified in the manual ad If the instrument is not used as described in the manual the protection provided by the instrument may be impaired D 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
38. INT 2 Select Test By Mode 3 ABS NXT 3 Select Test By Number 4 MUL_4P 4 List Tests 5 CP 5 Add New Tests 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 Select Test NORM ABSORBANCE 1 HBSAG Name ABS BL N 2 TSH Pri 450 Sec 0 3ABS 4 MUL_4P NORM 5 CP DIFF Version No RBK 3 4004 Effective Date Nov 2012 Page 59 of 121 User Manual readwell TOUCH 9 1 Absorbance Mode Select the test and point to RUN option Select Tesi ESC TEST OPERATIONS 1 HBSAG RUN SEL 1 Select Test By Name 2 TSH PRINT 2 Select Test By Mode 3 ABS NXT 3 Select Test By Number 4 MUL_4P 4 List Tests 5 CP 5 Add New Tests 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 Name ABS NORM ABSORBANCE Name ABS NORM ABSORBANCE Pri 450 Sec 0 BL N Pri 450 Sec 0 BL N ABS ABS ABS ABS ABS ABS ABS ABS 1 2 3 5 1 2 3 5 Is Plate Loaded 7 Is Plate Removed Version No RBK 3 400A Effective Date Nov 2012 Page 60 of 121 User Manual readwell TOUCH Details of absorbance of all wells in table format for each strip will be displayed on
39. ME amp FEED keys operates only when it is in List Test screen or the first screen after initializing Version No RBK 3 400A Effective Date Nov 2012 Page 15 of 121 User Manual readwell TOUCH readwell TOUCH 18 07 12 Clinic name Serial Number MENU Select Test 1 HBSAg 6 PER_ABS RUN SEL 2 HOVAb 7 CRP PRINT 3 UPT 8 KIN NEXT 4 TSH 9 SIN PREV 5 CPC 10 CP DEL PLATE DATA User can select List Test screen as shown below MAIN MENU TEST OPERATIONS 1 Test Operations 1 Select Test By Name 2 Technical Diagnosis 2 Select Test By Mode 3 Utilities 3 Select Test By Number 4 View Plate 4 List Tests 5 Serial Communication 5 Add New Test Select Test ESC HBSAg HCVAb UPT RUN SEL 1 2 3 4 TSH PRINT 5 CPC 6 PER_ABS 7 ABS 8 KIN 9 SIN 1 0 CP NEXT PREV OVNAD gt UTOZCZO DEL PLATE DATA Version No RBK 3 4004 Effective Date Nov 2012 Page 16 of 121 User Manual readwell TOUCH Select FEED button present on the keypad It will display following screen for selecting the particular test In this way user can directly run the selected test by just entering the valid test no Select Test ESC Name ABS NORM ABSORBANCE 1 HBSAg 2 HCVAb 3 UPT 4 TSH 5 CPC 6 PER_ABS 7 8 9 1 Pri 450 Sec 0 BL N ABS ABS ABS ABS ABS PRINT 1 2 3 4 5 RUN SEL NEXT ABS KIN SIN 0 CP PREV ONAS gt PUOZCZO DEL Numeric Value 7 123 4 5
40. MODE UPTAKE KINETIC Page 9 of 121 User Manual readwell TOUCH 3 3 Technical Specification of readwell TOUCH Human Machine Interface TOUCH PANEL KEYPAD 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 Photometric Linearity 25A Filters Type of filter Wave Length Half Bandwidth Selection Light Source Display Curve Plotting Plate Carrier Movement Printer Memory Analysis Mode Narrow band Interference 405nm 450nm 492nm 630nm with two optional filters namely XXX and YYY editable 10nm 2nm Automatic by Stepper Motor Tungsten halogen lamp 20 Watts 6 Graphics LCD Negative Blue Transmissive STN 320 x 240 dots Graphical Representation on Printer Precisely through the stepper motor Built in Thermal Printer 52 columns Battery backup supporting 2500 open channels 64 KB Non Volatile RAM 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 Version No RBK 3 400A Effective Date Nov 2012 Page 10 of 121 User Manual readwell TOUCH 75 Watts 115 230 Volt 10 50 60 Hz Operation Position On horizontal flat rigid and vibration free surface Operating Conditions Temperature From 18 C to 35 C Relative Humidity Up to 80 Storage Conditio
41. NGS e daa hia e aa es loe a Qian 12 ADIPACKAGIN it ti tai 12 4 3 INSTRUMENT TRANSPORTATION cccccccccccsssssscsccccccccsssssesccsccsssssussceccesssssuuuuseeececessssuuunsuececess 12 4 4 STORAGE OF INSTRUMENT nii 12 5 INSTRUMENT DESCRIPTION ssssssssssssseeeeeee 5 1 INSTRUMENT WORKING PRINCIPLE cccccccssssssceccccccccesssssescceccessususssescceccesssuuesscecescssssuuuasesecesess 3 Zu PER SPEC IDV E MIE WS e do e ds ea ed Sack e 14 5 2 T ERONI VIEW nia ais 14 DDD REAR VIEW ST Tes o ie SER TELE AA As 14 NO SEPA Dan ote See aa hs nae ae PERN Cet oe ARR ts 15 6 INSTALLATION PROCEDURE amp VERIFICATION CRITERTA ssccsssssssseees 18 6 L UNPACKING INSTRUCTIONS O ODO de 18 6 2 PLACING THE INSTRUMENT ccccsssescsccccccccesscscsccccceccssssscecescssessuesscsecssesscssseusesescessssseeuensess 18 6 3 POWER SUPPLY REQUIREMENTS cccoccnnccccccconononnnaniconccnnononenananocconnnnononnnnnononcnnononnnnanocicccnnnnnnnnos 18 6 4 PROTECTIVE GROUNDING ian e a a a a a a a a a aii 18 Version No RBK 3 400A Effective Date Nov 2012 Page 2 of 121 User Manual readwell TOUCH O25 PRINTER la a o NA Io 18 6 6 STARTUP INSTRUCTIONS uan dd dit 20 6 8 MICRO TITER PLATE CARRIAGE ccccccccccccccssessscscccccccsssesscecsccsssseesuscesesccsssssseseussesccssseseunensess 22 6 9 PLATE LOADING amp PIPETTING PROCEDURE cccnonncocccccnnonononanicocccnnononnna
42. Nov 2012 Page 83 of 121 User Manual readwell TOUCH When you want to run such an accepted test select that particular test for instant CUTOFF mode and point to RUN option present on the Select Test screen Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 0 DUP N SIMUL 1 2 3 4 5 6 Load Blank Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 0 DUP N SIMUL 1 2 3 4 5 6 7 Load Controls 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 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 Version No RBK 3 4004 Effective Date Nov 2012 Page 84 of 121 User Manual readwell TOUCH C In Multi Standard Single Standard Absorbance Uptake Mode Name TSH MULTI STANDARD Pri 450 Sec 0 No of Samples 0 DUP N SIMUL 1 2 3 4 5 6 Load Blank 7 Name TSH MULTI STANDARD Pri 450 Sec 0 No of Samples 0 DUP N SIM
43. ON You will get this message if paper is not loaded properly or lever is not at correct position Check all possibilities 1 Printer disabled Also check ON LINE and FEED LED glowing or not and Disable Printer YES NO when you switch ON the instrument check paper is moving forward or not If LEDs are not glowing and paper 1s not moving forward contact service engineer 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 2 Check Light Path CH x 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 Where x is any channel number X 1 2 3 4 5 6 7 8 will indicate all channel numbers having less reference voltage like Check Light Path CH 136 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 A If in the Cut Off and Multi standard mode the controls and nvalid Assa standards are not ok then this error message will appear If Number of saved tests exceeds the memory limit of 250 4 Memory Full tests then
44. PLICATE s s s s s 88 12 PATIENT IDENTITY SAMPLE IDENTITY ENT RY cccccsssssssssssssssssssssssscssceces 90 13 SAVE PLATE AND SA VE RESULTS 93 14 VIEW STORED DAWA ciscstesccssticiscecsdeetesccadieldestesscsecnecedsesiecacnscdacelsescesecsecsecedscsdecsesscbacecseseese 95 Version No RBK 3 400A Effective Date Nov 2012 Page 3 of 121 User Manual readwell TOUCH 15 UTILITIES PAPA UN En E 98 15 1 DATE amp IAS A AE 98 1522s PROGRAM FILTER Sino dll sia lada l dla iii 99 15 3 PRINTER ON OFF SETTING concncccncnnnnnononononononononononononononononononenonenenonononone nene ne nene ne nena na nana nananans 99 154 ENTER CLINIC NA ME A A A AI et DA A abi 100 15 5 SHAKER PLATE SHAKING MODE cccccccecesssssssecesececsesensnsecececcesesesesseaeceseesesenessseaeeeeees 100 15 6 COMMUNICATION SETTINGS 3 ccccccoconononononononononononononononononononenonononenene none ne nene na nene ne nene ne nena nanannns 103 15 8 INSTALL USB DRIVER kaa ia atinada ai kaaa 104 ISO AUTO PRINTD O Nico a IAA 104 STO PASSWORD 0d td aa aeae raaa iii 105 16 SERIAL COMMUNICATION ocococononononononononononononononinonononononononononononononononicoconinicicininininosos 108 TG sb SENDARES UL LS usais iva 109 16 2 SEND TEST RECORDS ios MK dead sade MINI IK MAI 111 16 3 RECEIVE TEST RECORDS isis besd
45. Shake Time 0 sec Shake Speed 0 Start Stop Page 100 of 121 User Manual readwell TOUCH Shake Time Shake Time 0 sec Shake Speed 0 Start Stop Numeric Value 20 123 456 ENTR Shake Time 7 890 CLR Shake Speed The total shake time can be entered in seconds Start Stop Numeric Value 05 123 4 5 6 ENTR 7 8 90 CLR 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 Version No RBK 3 400A Effective Date Nov 2012 Page 101 of 121 User Manual readwell TOUCH 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 Shake Time 20 sec Shake Time 20 sec Shake Speed 5 Shake Speed 5 Start Stop Is Plate Loaded Yes NO After selecting YES the tray will go inside and instrument will do the shaking of plate for the given time period with selected speed 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 Shake Time 20 sec Shake Speed 5 Start Stop Is Plate Removed Yes NO Similarly to stop the Shaking process in between select STOP option present on the screen A
46. T 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 1 PLATE RESULTS 2 PATIENT RESULTS SIN 02 01 12 NO SAMP ABS Al C1 0 083 B1 S1 0 544 C1 S2 0 367 NO DATE TEST MODE ESC DI S3 0 538 4 02 01 12 SIN S BL ee MORO 0 700 3 01 01 12 TSH SEL OS _ 2 30 12 11 HBSAG 2 2 NA 1 28 12 11 CPC S14 0 326 0 326 195 6 NEG VSP 14 15 0 491 0 491 294 7 EQ VSP 15 4 02 01 12 SIN NEXT PREV PRINTMATRIX SENDDATA PRINT Press Select key ot proceed Version No RBK 3 400A Effective Date Nov 2012 Page 95 of 121 User Manual readwell TOUCH Print Matrix will print the details of entire plate in ma trix 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 Note User can directly view the details of Plate Results by accessing it through Plate Data option present on the Select Test screen Select Test ESC HBSAg HCVAb UPT TSH RUN SEL CPC PRINT PER_ABS CRP KIN SIN 0 CP NEXT PREV OVDOXAOVOZCZO 4 2 3 4 5 6 7 8 9 4 DEL PLATE DATA 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 op
47. TABS NC PC CF l QC1 gt Y 0 500 Interpretation Cut off Index Range option will are using a Greyzone option the QC2 reyzone N not work QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 Enter Value Value 10 00 Enter Value Numeric Value y Enter Greyzone percentage value Select ESC option after entering Greyzone value to come out to the parameter screen Version No RBK 3 4004 Effective Date Nov 2012 Page 40 of 121 User Manual readwell TOUCH 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 630 ESC No Factor QCVal Mes Rem SAVE BL 0 100 NC 1 000 0 150 PC 1 000 0 500 LC 1 000 CC 1 000 CUTFAC 0 200 CUTABS NC PC CF QC1 gt Y 0 500 Interpretation QC2 Greyzone Y 10 00 QC3 Cut off Index N QC4 Range Version No RBK 3 4004 Effective Date Nov 2012 Page 41 of 121 User Manual readwell TOUCH 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 Name HBSAG POS CutOff Cut off Index is the ratio of Pri 450 Sec 630 ESC No Factor QCVal Mes Rem SAVE BL 1 0
48. UL 1 2 3 4 5 6 7 Load Calibrators 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 Version No RBK 3 400A Effective Date Nov 2012 Page 85 of 121 User Manual readwell TOUCH NOTE User can view the Saved Graph from the Test parameter screen before re ruming the same test Name TSH MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 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 Interpretn Y Range High gt 15 25 Low lt 9 46 Graph 4 PARAMETER Y vs X ABS vs CONC To change values press EDIT On selecting GRAPH option it will display following screen where user can select PLOT option in order to view the Valid GRAPH Screen No Conc Abs No Conc Abs 1 0 000 0 220 10 00 0 454 25 00 0 725 50 00 1 026 100 00 1
49. UP 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 Version No RBK 3 400A Effective Date Nov 2012 Page 53 of 121 User Manual readwell TOUCH 1 Selection of Controls For High control select touch zone HI CO N Following message appears High Control Required Yes No Select YES and then enter range of control HIGH and LOW Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC DUP Y DUP Y SAVE HICO 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 Enter range of control HIGH and LOW as per reagent manual Enter High Range Value Enter High Range Value High 0 000 High 25 03 Low 0 000 Low 10 54 Numeric Value 1 2 Version No RBK 3 400A Effective Date Nov 2012 Page 54 of 121 User Manual readwell TOUCH 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 Name MUL_4P Pri 450 Sec 0 MULTISTANDARD BLY 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 Note Entry of LO CO is s
50. User Manual readwell TOUCH readwell Touch ELISA Plate Analyzer User Manual R 232030MiI lt ROBONIK INDIA PVT LTD Plot No A 374 TTC MIDC Industrial Area Mahape Navi Mumbai 400 710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No RBK 3 400A Effective Date Nov 2012 Page 1 of 121 User Manual readwell TOUCH TABLE OF CONTENTS 1 GENERAL INFORMATION s ss 5 k1 WARRANTY INFORMA TION a daa 5 12 TECHNICAL ER VICE cies Scots dt stds e eaaeo e 5 LS CONTACT ddr ia ads tol ads Dios alada idas toi dales dde 5 2 GENERAL SAFETY WARNINGS s ssssseseseeesesececece 6 2 1 DANGER WARNINGS SYMBOLS 1 ccccccccccccccssssscsccccceccsscssseececcssssusuusscecescssssesesecececessesesunensgss 6 22 WISE OE THE INSTRUMENT ie seceesed decoder eyate Ha ia akak 7 3 INTRODUCTION sisssisssiiossi iesciescassescsasteusccastscneicedevescestetecsassousccesticvususiavesdestesecsassevsccescccsadeds 8 3 1 DESGRIPTION ota aaa da adri 8 323 SPECIAL FEATURES e OSES a o 8 3 3 TECHNICAL SPECIFICATION OF READWELL TOUCH ccceeecccceececcccecececceccececcesccccaneeecees 10 4 PACKAGING TRANSPORT AND STORAGE ccccssssscssssseccssssssccccsssscccsssssccsssssscees 12 4 l GENERAL WARNI
51. Z Abs any absolute value CF Cut off Factor ALg Anti LOG Version No RBK 3 400A Effective Date Nov 2012 Page 36 of 121 User Manual readwell TOUCH 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 1 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 the 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 Or 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
52. aase ches sad e aha besteatueeedaadawess 112 17 TECHNICAL DIAGNOSIS ov giccissccdedicccdecccccccaddsstccscsccsscscdocesdss esdecsddessdcscsdesssssdosssdessestossvias 115 1 AL ACEBAR MEMORY rta ticas 115 1722 LAMP AMPLITUDE iii id aid ee a ee ed as AS 116 1734 PRINTERS BUR TEST till d 117 19 DECONTAMINATION J s0 0s0s0s0s0sse 120 19 1 DECONTAMINATION PROCEDURE cccccccccsssssssececccccccessssescsccsesesssssussesccscsseseusesceccesseseeuenenss 120 19 2 PURPOSE OF DECONTAMINATION cccceessssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssnssssenes 120 19 3 GENERAL CONSIDERATIONS ccccssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssneees 120 19 4 PROCEDURES di cli 120 20 SAFETY CLEARANCE CERTIFICATE 0 00000000000000000000000000000000000000000000000000000000 121 Version No RBK 3 400A Effective Date Nov 2012 Page 4 of 121 User Manual readwell TOUCH 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 ROBONIK will at its discretion repair or replace parts which may be found defective in the warranty period The wa
53. age of control with no remark for any control and 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 Version No RBK 3 400A Effective Date Nov 2012 Page 70 of 121 User Manual readwell TOUCH 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 Name TSH MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC DUP N 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 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 foll
54. ate Nov 2012 Page 25 of 121 User Manual readwell TOUCH E Select primary and secondary filter NORM ABSORBANCE Name ABS BL N ESC Pri 405 Pri 40 Sec 0 Select Filter Val 0 405 450 492 630 NA NA XXX YYY F If blank is required select BL NORM ABSORBANCE ee Name ABS BL y ESC If you select BL Y it will read first well first strip Al as a blank PASOS eee SAVE and subtract the absorbance of blank NORM well from all other well s MODE absorbance DIFF 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 DIFF ABSORBANCE Name BL N ESC Name ESC Pri 405 Sec 0 SAVE Pri 405 Sec 0 SAVE NORM NORM MODE MODE DIFF DIFF Version No RBK 3 400A Effective Date Nov 2012 Page 2 of 121 User Manual readwell TOUCH 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 concentra
55. com Website www robonik in Version No RBK 3 400A Effective Date Nov 2012 Page 5 of 121 User Manual readwell TOUCH 2 GENERAL SAFETY WARNINGS 2 1 Danger warnings symbols The following symbols are used to inform the user of the safety rules This symbol indicates generic danger It means that serious damage can occur to the operator if described precautions are not observed This symbol indicates 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 involves the handling of samples which can be infected urine or human serum In this condition 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 followed This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal General Symbols Symbol for Manufacturer E 09 gt Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE Symbol for AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY m u Version No RBK 3 400A
56. ding the Results check whether the Serial cable USB cable is connected to both the ends of the instrument and the computer respectively MAIN MENU SERIAL COMM 1 Test Operations 2 Technical Diagnosis 1 Send Results mmama 3 Utilities 2 Send Test Records 4 View Plate 3 Receive Test Records 5 Serial COMMUNICATIONS coccoiancanconian ono ane be ee eee cee SERIAL COMM SERIAL COMM 1 Send Results 1 Send Results 2 Send Test Records 2 Send Test Records 3 Receive Test Records 3 Receive Test Records Sending Send Results Version No RBK 3 400A Effective Date Nov 2012 Page 109 of 121 User Manual readwell TOUCH 3 These Results are send through Application which are created in csv format Convert the corresponding format to Excel file which is created as shown below ES Microsoft Excel PRLOG2012831_1 SS Ble git Yew met mel Tob Dala Wd Heb F12 bA A Cc D E G H 1 2 TEST RESULTS 3 4 Date TestName Mode Result PID Remark 5 6 310812 SIN S 1135 CIDI 7 E 31 08 12 SIN S m66 CD g 10 30892 SIN 3 9642 CID 11 ma 3108 2 SIN S 78 16 aw C 13 E 31 08 12 SIN S 1893 IDs 16 31082 SIN 5 7684 CIDS 17 1B 310812 SIN S 67 02 CID 19 20 310842 SIN S 119 clipe 21 22 310872 SIN 3 1019 CID 23 24 310812 SIN S 90 22 CID10 25 25 3108412 SIN S 6482 CIDI 27 28 310872 SIN S 325 CIDI2 29 a 308 2 SIN S 73 61 CIDI3 31 32 310842 SIN S 72237 CD14 33 M 4 gt H PRLOGZ0
57. ect PRINT option to obtain the print out Origin at X 0 000 y 0 000 X div 2 500 y div 0 150 3 00 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 select ACCEPT TEST option to save graph whenever you run the test with calibrators Version No RBK 3 4004 Effective Date Nov 2012 Page 77 of 121 User Manual readwell TOUCH 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 the bottom of the screen Name TSH MULTI STANDARD Pri 450 Sec 0 BLY CAL7 Range High gt 16 61 Low lt 10 30 NXT HI CO High gt Low lt LOCO High gt Low lt PREV NO SAMP ABS AVG CONC Al B 0 050 0 050 SAVE C1 0 070 0 070 0 000 RESULT C2 0 257 0 257 2 500 Invalid Assay LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS 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
58. ed filters either Monochromatic act Interpretation or Bichomatic by selecting the filter values from Qc2 Greyzone N Select Filter Val region QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 E According to the reagent manual change Blank NCs PCs to YES for QC check Name HBSAG POS CutOff Pri 450 Sec 630 No Factor QC QCVal Mes Rem BL 0 NC O 1 000 PC O 1 000 LC O 1 000 CC O 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 Version No RBK 3 400A Effective Date Nov 2012 Page 30 of 121 User Manual readwell TOUCH F Entry of Blank and Blank QC values Select BL to enter blank details Name HBSAG POS CutOff Pri 450 Sec 630 No Factor QCVal BL 0 000 NC 1 000 0 000 PC 1 000 0 000 LC 1 000 CC O 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 G After selecting BL enter total number of blanks by selecting No of Blanks Maximum 5 blank No of Blanks 1 Values Of BL lt 0 000 Numeric Value 1 1 2 3 4 5 6 ENTER CLEAR H Enter the QC value of the blank by selecting the touch Zone Values of BL lt No of Blanks 1 Values Of BL lt 0 000 Numeric Value 0 100 1 2 3 4 5 6 Version No RBK 3 400A Effective Date Nov 2012 Page 31 of 121 User Manual I Entry of Negative co
59. ence 7 Check the micro wells before use They should be scratch free The micro well track in the READWELL TOUCH has been designed in such a way that the micro wells are totally protected from scratches ES 8 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 connecting 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 Version No RBK 3 400A Effective Date Nov 2012 Page 24 of 121 User Manual readwell TOUCH 8 PROGRAMMING MODES 8 1 Absorbance Mode In this mode the instrument gives only absorbance values of all wells of the respective plate Programming a New Test A Select Test Operation B Select Add New Test MAIN MENU TEST OPERATIONS 1 Test Operations 1 Select Test By Name 2 Technical Diagnosis 2 Select Test By Mode 3 Utilities 3 Select Test By Number 4 View Plate 4 List Tests 5 Serial Communication 5 Add New Test Select mode of operation Absorbance in Add New Test Select Test Mode 1 gt Absorbance 2 gt Single Standard 3 gt Cut off 4 gt Multi Standard 5 gt Percent Absorbance 6 gt Uptake 7 gt Kinetic D Enter Test Name NORM ABSORBANCE NORM ABSORBANCE Name BL N Pri 405 Sec 0 NORM MODE DIFF Version No RBK 3 400A Effective D
60. esent on the List Test screen Select Tesi ESC Name HCV POS Cut Off 1 TSH RUN SEL Pri 450 Sec 0 No of Samples 0 DUP N SIMUL 2 ABS PRINT 3 HCV NXT 4 MUL_4P 5 CP Version No RBK 3 4004 Effective Date Nov 2012 Page 64 of 121 User Manual readwell TOUCH 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 Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 10 DUP N SIMUL 1 2 5 6 7 B 3 NC S4 NC 5 NC S6 PC S7 PC S8 St 9 S2 S10 Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 0 DUP N SIMUL 1 2 5 6 B NC NC NC PC PC Numeric Value 10 1 2 C After entering No of samples select RUN The plate loading tray will come out and the following message will appear Is plate loaded YES NO Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 10 DUP N SIMUL 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 Version No RBK 3 4004 Effective Date Nov 2012 Page 65 of 121 User Manual readwell TOUCH 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
61. essories 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 b Other Biohazard YES NO If YES Please specify Version No RBK 3 4004 Effective Date Nov 2012 Page 121 of 121
62. ferent modes of Operation and saved in instrument program memory TECHNICAL DIAGNOSIS TECHNICAL DIAGNOSIS 1 Clear Memory 1 Clear Memory 2 Lamp Amplitude 2 Lamp Amplitude 3 Printer Selftest 3 Printer Selftest Clear Results Clear Test Records Select Clear Memory it will display the message string Clear Results Yes No Select Yes in order to clear the Results stored in the memory This will only clear the Patient Results and Plate Results stored in the memory by displaying the message Clearing Memory Similarly another message string Clear Test Records Yes No will be displayed on the screen These records are the Tests created in the particular modes Select Yes to delete the Test Records stored in the memory Version No RBK 3 400A Effective Date Nov 2012 Page 115 of 121 User Manual readwell TOUCH 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 1f 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 y
63. following message appears Invalid Assay and a remark either HV or LO for that QC condition Name HBSAG POS Cut Off NOTE The absorbance of Pri 405 Sec 0 ESC controls should not go above No Factor QCVal Meas ACCEPT 3 50 If it is gt than 3 50 it BL 1 0 100 0 105 TEST NC 3 1 000 0 150 01200 PC 2 0 100 0 500 01456 PRINT that control In such a case will show the remark HI for LC O 1 000 edit the control absorbance CC 0 1 000 CUTFAC 0 200 CUTABS 0 563 DISPLAY VALUE QC1 2 560 HI QC3 LOAD Invalid Assay NEXT 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 ma nual 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 Version No RBK 3 400A Effective Date Nov 2012 Page 69 of 121 User Manual readwell TOUCH NC VALUE 0 200 NC1 0 150 NC2 0 350 HI NC3 0 200 HI When you go back you will get the edited values for aver
64. fter 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 Version No RBK 3 400A Effective Date Nov 2012 Page 102 of 121 User Manual readwell TOUCH 15 6 Communication Settings It is a toggle between USB and SERIAL communication User can either switch to USB or Serial communication by connecting their respective cables UTILITIES Version 3 4004 UTILITIES Version 3 4004 1 Date and Time ESC 1 Date and Time ESC 2 Program Filter 2 Program Filter 3 Printer On Off ON 3 Printer On Off ON 4 Enter Clinic Name 4 Enter Clinic Name 5 Shaker 5 Shaker 6 Communication Settings USB 6 Communication Settings SERIAL 7 CV Diagnostic OFF 7 CV Diagnostic OFF 8 Install USB Driver 8 Install USB Driver 9 Auto Print OFF 9 Auto Print OFF 10 Password 10 Password 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 RS 232 cable NOTE The option 7 CV Diagnostic OFF is not for users It is for factory use only Version No RBK 3 4004 Effective Date Nov 2012 Page 103 of 121 User Manual 15 8 Install USB Driver readwell TOUCH This option present in the Utilities helps the user to install the USB Drivers in their respective computers Remember t
65. hat before installing the USB drivers you must first switch on to the USB communication settings UTILITIES Version 3 4004 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 15 9 Auto Print ON UTILITIES Version 3 4004 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 Install USB Drivers YES NO 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 graph 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 Version No RBK 3 400A Effective Date Nov 2012 Page 104 of 121 User Manual readwell TOUCH 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 UTILITIES Version 3 4004 1 Date and Time ESC 2 Program Filter 3 Printer On Off ON 4 Enter Clinic Name 5 Shaker 1 Enable Disab
66. imilar to that of HI CO 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 Name MUL_4P Pri 450 Sec 0 MULTISTANDARD BLY 0 000 CAL7 ESC DUP Y DUP Y SAVE Low lt 10 54 HI CO Y High gt 25 03 LO CO Y High gt 16 61 Low lt 5 45 Interpretn Y Range High gt 0 000 Low lt 0 000 Graph 4 PARAMETER Y vs X ABS vs CONC Version No RBK 3 400A Effective Date Nov 2012 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 Page 55 of 121 User Manual readwell TOUCH Enter Normal Range for positive and negative samples Enter HIGH Range value High gt 15 25 Enter HIGH Range value High gt 0 000 Low lt 0 000 Low lt 9 46 Numeric Value 1 2 After entering all the parameters save the test by selecting SAVE option Name MUL_4P MULTISTANDARD Pri 450 Sec 0 BLY 0 000 CAL7 ESC DUP Y DUP Y SAVE HICO 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 4
67. ion No RBK 3 400A Effective Date Nov 2012 Page 75 of 121 User Manual readwell TOUCH Example Print out of MultiStandard test obtained from READWELL TOUCH MULTI STDS Name TSH Pri 450 Soc 0 BL N DUP N CAL 7 DUP N Graph 4 PARAMETER YvaX ABS wa CONC me CO N High gt Lowe Lo cO N High Low Range Y High gt 6 000 Lows 4 000 No Con Abs 1 0 000 2 500 2 17 000 2 010 3 51 000 1 340 3 170 000 0 860 5 510 000 0 470 6 1700 000 0 230 7 3400 000 0 100 Origin at x 0 000 y 0 000 x div 0 625 y div 0 126 0 000 000 4000 T4 21 07 08 wee 8 ME A wi w2 w3 wa ws we w7 wa wa w10 wi wiz ci 92 s10 s18 S26 334 842 850 558 866 874 82 apo OP10 opao 2 500 2 566 0 71 0 720 0 796 0423 0 744 0 728 0 768 0 141 0 700 0 151 0 000 10 00 3 175 3 226 3 275 1 880 2 203 2 240 2 255 0 527 2 141 0 475 NEG NEG NEG NEG NEG NEG NEG NEG NEG NEG B wi wz wa wa ws we wr we we wio wi wiz c2 s3 su s19 s27 835 543 851 ssa 887 575 S63 OPO3 SP OP40 OP27 2 010 2485 1432 1448 1 412 0 765 0 7098 0 756 0 729 0 173 0 700 0 134 17 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 C wi w2 w3 wa ws ws w7 we ws wio wi wi2 cs ss 812 s20 28 s36 844 852 560 568 576 884 OPIO oP12 OP20 oOP2B 1 340 2 603 0 081 0 801 0 154 0448 0 155 0 161 2 547 0 766 0 854 2 625 51 000 10 43 0 273 2 382 0 516 1 9003 0 823 053 10 30 2 440 2 444 1043 POS NEG NEG NEG NEG NEG NEG POS NEG NEG POS D wi wa w3 wa ws we wr we we wo wr wi2 c4 85 813
68. is showing the D M values for each and every well in table format Name KIN KINETIC Pri 450 Sec 0 D M D M D M D M 1 4 0 020 0 035 10 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 SENDPLATE LOAD NEXT Version No RBK 3 400A Effective Date Nov 2012 Page 80 of 121 User Manual readwell TOUCH 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 Wl W2 W3 W4 WS 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 sample B Wl W2 W3 W4 WS 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 Version No RBK 3 400A Effective Date Nov 2012 Page 81 of 121 User Manual readwell TOUCH e Example Print out obtained from READWELL TOUCH KINETIC Name KIN_450 Pri 450 Sec 0 Read Time 1 min Read Period 15 sec KIN_D 21 07 08 A wi w2 w3 w4 WS W6 W7 wea w9 wio w11 W12 0 160 2 653 0 843 0 831 0 889 0 515 0 835 0 822 0 838 0 228 0 786
69. le Password Utility 6 Communication Settings USB 7 CV Diagnostic OFF 8 Install USB Driver 9 Auto Print OFF 4 LOGOUT 2 Set Password 3 LOGIN 10 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 Disabl ADMIN PASSWORD ABCDEFGH 2 Set Password I J K LM N O QRSs T UV W 3 LOGIN te me er tat 3 4 5 6 7 8 9 Enter PASSWORD and select ENTER 4 LOGOUT Version No RBK 3 4004 Effective Date Nov 2012 Page 105 of 121 User Manual readwell TOUCH 15 10 2 SET PASSWORD This option helps to set the PASSWORD along with the USER name Password Utility ADMIN PASSWORD 1 Enable Disable A BC DE F G 2 Set Password 3 LOGIN 4 LOGOUT Enter PASSWORD and select ENTER USER MEDICARE ABC DE FAG I J K LM N O QRs T UV W YZ _ 1 3 4 5 6 7 8 9 Enter appropriate USER name and select ENTER Version No RBK 3 400A Effective Date Nov 2012 Page 106 of 121 User Manual readwell TOUCH 15 10 3 LOGIN After entering the Password user needs to select LOGIN Password Utility USER MEDICARE 1 Enable Disable A BC DE F G 2 Set Password l J K LMNO 3 LOGIN Q RSTUVW Y L 4 LOGOUT 3 4 To Login enable user enter the USER name and select ENTER
70. like Single Standard Absorbance amp Uptake Version No RBK 3 400A Effective Date Nov 2012 Page 82 of 121 User Manual readwell TOUCH 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 user can select the 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 If user recall the test with saved parameters then Using stored values strings should appeared in the printout A In CUT OFF Mode Name HCV POS Cut Off Pri 450 Sec 0 ESC No Factor QCVal Mes Rem ACCEPT BL 0 100 0 050 TEST NC 1 000 0 150 0 098 PC 0 100 0 500 2 658 PRINT LC 1 000 CC 0 1 000 CUTFAC 0 200 CUTABS 0 563 Display VALUE QC1 2 560 QC3 LOAD NEXT Range 10 00 B In Multi standard Mode Name TSH MULTI STANDARD Pri 450 Sec 0 BL Y CAL 7 Range High gt 16 61 Low lt 10 30 NXT HI CO High gt Low lt 0 000 LOCO High gt Low lt PREV NO SAMP ABS AVG CONC REM PID At B 0 050 0 050 SAVE Ci 0 070 0 070 0 000 RESULT C2 0 257 0 257 2 500 S1 0 200 0 200 2 100 NEG TSH1 S2 1 854 1 854 9 845 POS TSH2 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS Version No RBK 3 400A Effective Date
71. lows it to be used even when a printer is not available Readings can be conveniently noted down manually The other special features of readwell TOUCH are as follows e Option of Lamp saving mode e Selection of both primary and secondary filters e Latest technology with battery backup for 250 tests and more than 2500 results e Robust built in 52 column thermal printer with 384 stationary heads e Unique circuitry for long lamp life e Alphanumeric Patients ID entry e Editing of saved tests e Human machine user interface Touch panel Keypad e Multistandard curve up to 12 standard calibrations with one blank optional e Access to test by touch of key e Capability to connect to 80 column printer for direct report printout e Blank is optional e Setting of the Date and Time e Capable of storing deleting and recalling tests e Multiple calibrator modes e Selection of duplicates for both calibrators and samples e Extensive software for Cut Off mode e Selection of Positive Equivocal Negative cut off Version No RBK 3 400A Effective Date Nov 2012 Page 8 of 121 User Manual readwell TOUCH e 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 Version No RBK 3 400A Effective Date Nov 2012 Ae RK BS oS RA ABSORBANCE MODE SINGLE STANDARD MODE CUT OFF MODE MULTISTANDARD MODE ABSORBANCE
72. mples Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 0 DUP Y SIMUL Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 0 DUP Y SIMUL 1 2 3 4 5 6 7 8 9 10 11 12 B NC NC NC PC PC Numeric Value 10 1 2 Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 10 DUP Y SIMUL 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 Similarly user can load the samples and Sample Duplicates in all other modes Version No RBK 3 400A Effective Date Nov 2012 Page 89 of 121 User Manual readwell TOUCH 12 PATIENT IDENTITY SAMPLE IDENTITY ENTRY To enter Patient ID for all samples there is an option provided in loading screen shown as PID After entering number of samples either single or duplicate select PID A Individual PID entry Name HCV POS Cut Off Pri 450 Sec 0 No of Samples 10 DUP N SIMUL 1 2 3 4 5 B S3 NC S4 _ NC S5 NC S6 PC S7 PC S8 S1 S9 S2 S10 0o0NOoOg 0m0N 4 o Sample PID 1 PRST123 BRSTI2S BCDEFGH J K L MN O P ENTER RSTUV WX CLEAR 45678 9 0 OAN Da kW ND 4 o 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 Patient is entered with the help of Alpha numeric characters the combination must be as mentioned below Alphabets Versi
73. nacnononccnononnnninicinaccnnnananos 22 G LOSREADINGS CHECK ii aiitelas idiotas aara 23 7 PRECAUTIONS bas wicsccccesiccstecicsscceuscececosbsssecouscccosesscsseccuscscosesssceecosscccococbeseccoescscncocbeceecoeseccoesses 24 8 PROG RA MMIIN G MODES s ssssssssseseseeeee 25 Sil ABSORBANCE MODE AA a aa 25 9 29 INGLES TANDA RD cda a td tit Steet sra 27 8 3 CUT OFF MODE curada ala HUKAUKA 28 8 4 REVERSE CUT OFF MODE ocococonononononononononononononononononononononononononononononononononononononononononononeneneneness 44 8 5 IMULTESTANDARD MODE E e td 45 8 6 PERCENTAGE ABSORBANCE ocococonononononononononononononononononononononononononononononononononononononononeneninenenecess 57 Bef UPTAKE li an 57 BRINE DIG asian anidan da nan ea dba 58 9 RECALLING AND RUNNING OF STORED TEST PROGRAMBS s s0s0s0s0000000000 59 9 ABSORBANCE MODE isvtsitteressis bicesteasiesessaseoesicbesbsssevbeceseuesuesetsaseoes wi 60 92 CUD OER MODE iS A ese eee 64 9 2 A INVALID ASSAY IN CUT OFF MODE cccccccccccccsssssscscccccccssesssscscceccesessusesescccesscsueussesceeess 69 93 MULTTESTANDARD MODE wal dc ee seth Wal ie SAR RT he RARE 71 9 3 A INVALID ASSAY IN MULTI STANDARD MODE ccccccccccccccssessscsccccccsceessscececccsssusesseseceeess 80 10 RERUNNING ACCEPTED TESTS PROGRAMS s s s s 83 11 SAMPLE AND SAMPLE DU
74. ns From 10 C to 40 C Temperature Up to 80 Relative Humidity di ae E i i P Weight Approx 10 Kg Version No RBK 3 400A Effective Date Nov 2012 Page 11 of 121 User Manual readwell TOUCH 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 material Put copy of Safety clearance certificate copy of Safety clearance certificate 1s 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 has to be less than 85 and temperature between 10 C and 40 C Version No RBK 3 4004 Effective Date Nov 2012 Page 12 of 121 User Manual readwell TOUCH 5 INSTRUMENT DESCRIPTION 5
75. ntrol and its QC values Select touch Zone NC Name HBSAG Pri 450 Sec 630 No Factor BL NC PC LC CC CUTFAC 0 000 0 1 000 1 000 1 000 1 000 CUTABS QC1 QC2 QC3 QC4 POS CutOff ESC QC QCVal Mes Rem SAVE 0 100 Y Y Y N N Interpretation Greyzone N Cut off Index Y Range Pos 0 000 Neg 0 000 readwell TOUCH J Enter Number of Negative controls by selecting touch Zone No of NC s maximum 5 Negative Controls Enter the 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 No of NC s 3 Values Of X 1 000 Value of NC lt 0 150 Numeric Value 123 4 5 7 8 9 O 6 ENTER CLEAR Version No RBK 3 400A Effective Date Nov 2012 Page 32 of 121 User Manual readwell TOUCH K After the entry of No of NC s select ESC The below screen will appear on the display Name HBSAG POS CutOff Pri 450 Sec 630 No Factor QCVal Mes Rem BL 1 0 100 NC 3 1 000 0 150 PC O0 1 000 LC O 1 000 CC 0 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone N QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 L Entry of Positive Controls PC Select touch Zone PC Name HBSAG POS CutOff Pri 450 Sec 630 ESC No Factor QCVal Mes Rem SAVE BL 0 100 NC 1 000 0 150 PC 1 000 LC 1 000 CC 1 000 CUTFAC
76. olumn 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 W4 WELL ID OR SAMPLE NUMBER BL NC PC OR S1 S2 S83 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 Version No RBK 3 4004 Effective Date Nov 2012 Page 67 of 121 User Manual readwell TOUCH Example Print out of POS CUTOFF test obtained from READWELL TOUCH POS CutOM Name HCV Pri 450 Sec 0 NO Factor ac QCVal Meas BL 1 E 0 100 NC 2 0 000 Y 0 150 0 000 PC 2 0 100 Y 0 500 0 000 Lc 0 1000 N cc 0 1000 N CUTFAC 0 100 CUTABS VPCCF aci N QCZ N 10 0 acs N Cutoff Index N Range OA N HCV 21 07 08 A wi we w3 w4 w5 w wr wa wa wio wi wi B S4 s12 20 28 S36 S44 552 s60 S68 576 S84 OPD13 OPD21 OPD29 OPD37 OPD45 OPDS3 OPD61 OPD69 OPD77 OPDaS OPDS3 0 002 0 147 0 091 0 011 0 063 0 127 0362 0 072 0 400 1454 0743 0 222 0 000 1302 0 803 0
77. on No RBK 3 4004 Effective Date Nov 2012 Page 9 of 121 User Manual readwell TOUCH For example 1 In the first combination user can enter PID with 4 Alphabets and 3 Numbers That means entered PID should be PORS 123 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 4 But one 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 Enter Initial Sample number PRST ABCDEFGH J K L MN O P ENTER Q RSTUVWX CLEAR Numeric Value 01 We Be a a ae 123 4 5 6 ENTER 3 45678 9 0 7 89 0 CLEAR Enter Initial Alphabets Maxim
78. ou can enter QC equations for QC2 QC3 and QCA 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 1t 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 Version No RBK 3 4004 Effective Date Nov 2012 Page 39 of 121 User Manual readwell TOUCH 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 Name HBSAG POS CutOff Pri 450 Sec 630 ESC No Factor QCVal Mes Rem SAVE If you enter Greyzone percentage BL 1 0 100 10 00 instrument will show you NC 3 1 000 0 150 PC 2 1 000 0 500 LC O 1 000 makes the Cutoff Index Range the same as shown in screen It CC 0 1 000 option NO This means when you CUTFAC 0 200 CU
79. ou 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 LAMP AMPLITUDE 1 Clear Memory 1 Stability Check 2 Lamp Amplitude 2 Filter Amplitude 3 Printer Self test 4 Lamp Centering Check 1 Stability Check Filter 405 CH1 1921 8 1920 4 1919 4 1 Stability Check 1918 5 1918 0 LAMP AMPLITUDE 2 Filter Amplitude CH7 1899 1 Displays the Lamp Amplitude of all the filters nee 1897 4 1896 9 Version No RBK 3 400A Effective Date Nov 2012 Page 116 of 121 User Manual readwell TOUCH 2 Filter Amplitude LAMP AMPLITUDE LAMP AMPLITUDE 1 Stability Check 1 Stability Check 2 Filter Amplitude 2 Filter Amplitude Select Filter Val 0 405 450 492 630 NA NA XXX Displays the Lamp amplitude of a single selected filter Filter 450 CH1 1997 6 1997 5 1997 2 1997 1 1997 0 CH7 1891 1 1891 1 1891 2 1891 3 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 It is only for service purpose Version No RBK 3 400A Effective Date Nov 2012 Page 117 of 121 User Manual readwell TOUCH 18 Trouble Shooting AA CAUSE CORRECTIVE ACTI
80. owing screen Select Test ESC Name TSH MULTISTANDARD HBSAg Pri 450 Sec 0 HCVAb RUN SEL No of samples 0 UPT DUP N SIMUL TSH PRINT 1 2 5 6 CPC B PER_ABS NEXT C1 CRP KIN SIN 0 CP PREV 230900002 ONXOVTOZCZO DEL PLATE DATA Version No RBK 3 4004 Effective Date Nov 2012 Page 71 of 121 User Manual readwell TOUCH B To enter total No of HI controls select HI CO option and enter numeric value 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 Please Enter Col Entry 1 Numeric Value 1 2 For row entry select ROW option and enter row position HICO 2 ROW COL A 2 B 3 Please Enter Row Entry 1 Row Entry A B C D E F G H ENTER CLEAR Similarly you can enter No of LO Controls and locate its positions Version No RBK 3 400A Effective Date Nov 2012 Page 72 of 121 User Manual readwell TOUCH 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 Name TSH MULTISTANDARD Pri 450 Sec 0 No of samples 0 DUP N SIMUL 1 2 3 4 5 6 B HC C1 HC C2 C3
81. rea 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 ne xt 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 activates it Version No RBK 3 400A Effective Date Nov 2012 Page 21 of 121 User Manual readwell TOUCH 6 8 Micro Titer Plate Carriage E oO O S A 4 5 2 a S mH wo 2 9 qa 5 E 2 De m lga Tam tt a 90 de SERRA x Plate Camer Elisa Plate 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 Controls 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 Low Positive Control 05 Version No RBK 3 400A Effective Date Nov
82. rranty 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 mar hour expenses will be charged extra In case of tenders warranty would be as per tender terms and conditions 1 2 Technical Service ROBONIK 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 instruments The user should carry out ordinary maintenance The technical service of ROBONIK or an authorized service center with specialized technicians with suitable instrumentation and original spare parts only is always available for extraordinary maintenance repair under a yearly maintenance contract or on specific demand 1 3 Contacts Manufacturer European Authorized Representative ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area MAHAPE NAVI MUMBAI 400 710 INDIA Obelis s a 34 Av de Tervuren bte 44 B 1040 Brussels BELGIUM Tel 32 2 732 59 54 Fax 32 2 732 60 03 Tel 91 22 67829700 E Mail mail Cobelis net Fax 91 22 67829701 Email sales Crobonikindia
83. s the same as Positive Cut off Mode Only QC check conditions 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 Version No RBK 3 400A Effective Date Nov 2012 Page 44 of 121 User Manual readwell TOUCH 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 TEST OPERATIONS Select Test Mode 1 Select Test By Name 1 gt Absorbance 2 Select Test by Mode 2 gt Single Standard 3 Select Test by Number 3 gt Cut off 4 List Tests 4 gt Multi Standard 5 Add New Test 5 gt Percent Absorbance 6 gt Uptake 7 gt Kinetic After selecting Multistandard mode it will display following screen Name MULTISTANDARD Pri 405 Sec 0 BLN CAL2 ESC DUP N DUP N SAVE HICO N High gt LOCO N High gt Interpret n N Range Graph LINEAR Y vs X ABS vs CONC Version No RBK 3 400A Effective Date Nov 2012 Page 45 of 121 User Manual readwell TOUCH C Entry of Test
84. shown below Name TSH MULTI STANDARD ESC Pri 450 Sec 0 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 LOCO High gt 16 61 Low lt 5 45 PREV NO SAMP ABS AVG CONC REM PID Al B 0 050 0 050 SAVE Bi C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 Gi S1 0 200 0 200 2 100 NEG TSH1 H1 S2 1 854 1 854 9 845 POS TSH2 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS Version No RBK 3 400A Effective Date Nov 2012 Page 74 of 121 User Manual readwell TOUCH 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 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 WELL NUMBER WELL ID OR SAMPLE NUMBER PATIENT IDENTIFICATION WELL ABSORBANCE SAMPLE CONCENTRATION INTERPRETATION REMARKS W1 W2 W3 W4 B Cl C2 C3 OR S1 S2 S3 RAMESH VIKAS etc 0 050 0 098 0 085 0 738 0 689 2 578 POS NEG EQ Remember that Negative sign result is interpreted as zero both in printout as well as on screen Vers
85. the paper flap in the direction as shown in the following figure till you get the locking sound Use Thumb impressions to push the cover Press the paper feed switch until the paper feeds straight and smoothly LEA T ANS otf d Cag DY ae nga 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 When the paper is almost finished red lines appear on both sides of the paper Version No RBK 3 400A Effective Date Nov 2012 Page 19 of 121 User Manual readwell TOUCH 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 ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area MAHAPE NAVI MUMBAI 400 710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 The instrument will print the model name readwell TOUCH Version number Clinic Name current Date with Time readwell TOUCH 18 07 12 Clinic name Serial Number MENU Select Test 1 HBSAg 6 PER_ABS RUN SEL 2 HCVAb 7 ABS PRINT 3 UPT 8 KIN NEXT 4 TSH 9 SIN PREV 5 CPC 10 CP DEL PLATE DATA User can select a saved test by first touching the required Test Name on
86. the connection of stepper motor which is used to move filter tray 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 connection to these sensor and also the connection of stepper motor which is used to move plate carrier Page 119 of 121 User Manual readwell TOUCH 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 e 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 Glo
87. the screen as shown below Name ABS NORM ABSORBANCE Pri 450 Sec 0 BL N ABS ABS ABS ABS ABS 1 2 3 4 5 0 028 0 145 0 100 0 017 0 089 0 112 0 111 0 093 2 568 0 396 0 015 ESCPRINTMATRIX SEND PLATE LOAD NEXT Version No RBK 3 400A Effective Date Nov 2012 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 Wl W2 W3 W4 W5 W6 0 125 0 250 0 350 0 450 0 550 0 650 Using SEND PLATE plate data can be sent 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 Page 61 of 121 User Manual readwell TOUCH Example Print out of ABSORBANCE test obtained from READWELL TOUCH 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 NORM ABSORBANCE Name ABS BL N Pri 450 Sec 0 ABS 21 07 08 A wi W2 W3 WA ws W6 W7 Ws w9 w10 Wi w12 0 028 0 145 0 100 0 017 0 089 0 135 0 362 0 078 0 410 1 440 0 746 0 224 B wi W2 W3 W4 W5 W6 W7 W8 wa w10 w11 W12 0 058 0 151 0 386 2 553 0 111 1 479 2 593 0 081 2 517 0 781 0 730 0 005 W1 W2 W3 WA WS W6 W7
88. tion 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 Name SIN_STD SINGLE STANDARD Pri 450 Sec 0 BL Y 0 000 CAL1 ESC DUP N DUPN SAVE HI CO N High gt Low lt LO CO N High gt Low lt Interpret n N Range High gt Low lt Entry of all the parameters is similar to Multi standard mode Please refer Multi standard for entry of parameters Version No RBK 3 400A Effective Date Nov 2012 Page 27 of 121 User Manual readwell TOUCH 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
89. tion 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 01 01 08 Test MUL_4P M Result PID Remarks 1 PLATE RESULTS M 10 48 VSR1 EQ 2 PATIENT RESULTS MUL_4P M 12 63 VSR2 POS MUL_4P M 7 450 VSR3 NEG MUL_4P M 13 80 VSR4 POS SIN S 267 7 NRA1 EQ SIN S SIN S S SIN 220 3 NRA2 NEG 180 2 NRA3 NEG 326 7 NRA4 POS ESC NEXT PREV PRINT Version No RBK 3 400A Effective Date Nov 2012 Page 96 of 121 User Manual readwell TOUCH 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 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 and then save the new samples at that location 2 If atest 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 01 01 08 Test MUL_4P MUL_4P MUL_4P MUL_4P SIN SIN SIN SIN M Xx Xx Xx X S S S S Result 10 48 12 63 7 450 13 80 267 7 220 3
90. um 4 characters Enter Initial Well Number This is the starting well location of any particular batch Version No RBK 3 400A Effective Date Nov 2012 Page 91 of 121 User Manual readwell TOUCH Enter last sample number Enter initial PID number Numeric Value 10 Numeric Value 123 1 2 3 4 5 6 1 4 5 6 ENTER 7 8 9 0 i CLEAR Enter Initial PID Number This is the starting Enter last Well Number This is the last well number of any particular batch location of any particular batch The final screen will appear which displays the sequential IDs of patient samples for the well location that is selected PID PRST123 PRST124 PRST125 PRST126 PRST127 PRST128 PRST129 PRST130 PRST131 PRST132 1 2 3 4 5 6 7 8 9 1 Go to the next and previous 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 8 Ty y y 8 Op Delete previous PIDs Yes NO Version No RBK 3 4004 Effective Date Nov 2012 Page 92 of 121 User Manual readwell TOUCH 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 Pri 450 Sec 0 BL Y Range PERCENTAGE 10 00 NO SAMP ABS AVG CONC REM PID At B 0 050 0 050 NC PRINT SAVE PRINT RESULTS RESULTS MATRIX B In Multi standard or any calibrator mode
91. ved hands should be considered contaminated at all times and must be kept away from eyes mouth and nose at all times e Mucous membranes are considered prime entry routes for infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols e Eating and drinking while decontaminating instruments is not advisable 19 4 Procedure e 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 e 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 e Reassemble the unit and discard the used gloves and towels Version No RBK 3 400A Effective Date Nov 2012 Page 120 of 121 User Manual readwell TOUCH 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 III Fax Post Code Model No Serial No Acc
92. w8 w9 w10 Wi W12 0 065 2 596 0 135 0142 0 141 0 182 0 108 0 112 1 585 1 530 0405 2 635 ti ae El A a ya WA NZ Wa Wa WES We We WA We wig WA WIZ 0 072 01802 2836 0 143 2650 O 077 0158 0170 1 504 8071 048 022 E ai e Wa We NE WE Wr we WS Wi Wt WWT 2 541 0 14 Onde 6 094 68 0173 2653 0191 007 2658 0 232 0222 E YA WA We WA WS WA WA We WS WG WA WAR 2614 2682 0 188 0 130 2648 GAS 8178 0071 268 0 9583 0807 GAZE G arg Wa Wa WA WS We VET Wa We Wis WIT WE 1 4 085 UT 0407 26 Y 0 588 GAGS 2571 0185 0147 019 2818 0 081 Li y WO w ws WA WO WA WO We Wa Wio Wn WAA 0 071 00 123 0 118 0 054 OMe 0 08 02 Q 0093 Bede 0308 0018 Version No RBK 3 4004 Effective Date Nov 2012 Page 62 of 121 User Manual readwell TOUCH Differential Absorbance Mode In differential absorbance mode the instrument will give the absorbance difference each set of ODD number strip and EVEN number strip Name ABS DIFF ABSORBANCE It is showing the absorbance only for Pri 450 Sec 0 even number strips This absorbance ABS ABS ABS ABS ABS ABS 1 2 3 4 5 6 0 900 1 700 0 900 each well of strip 1 and well of strip values are actually differences between 0 200 1 000 1 800 2 You can get the difference between set 0 300 1 100 1 900 of 1 2 3 4 5 6 7 8 9 10 and 11 12 It is 0 400 1 200 2 000 0 500 1 300 2 100 not possible to change this combination 0 600 1 400 2 200 0 700 1 500 2 300 0 800 1 600 2 400 ABS ABS ABS print of entire

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