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User Manual - Robonik India.in
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1. ay AL ass 7 3 3 TECHNICAL SPECIFICATION OF READWELL 8 4 PACKING TRANSPORT AND 5 9 4 1 ehe tct ete eta bte uon red Urdu rota 9 Zoo PACA A 9 4 3 INSTRUMENT 8 9 44 STORAGE OF INSTRUMENT Ta vod zu du gU 9 5 INSTRUMENT 2 10 5 1 INSTRUMENT WORKING PRINCIPLE 71 4 44 10 52 WTEBSPECIVE VIE WW eee S ss s aus 11 55 W uuu asnukuna m 11 S y 12 6 INSTALLATION PROCEDURE AND VERIFICATION CRITERIA 13 6 1 UNPACKING 8 eaae agens 13 6 2 PLACING THE INSTRUMENT a aa ar co Y EE a ge cv SE Va EY aC Veg c D VE Io DR E URN Yd 13 6 3 POWER SUPPLY 6 13 O4 PROTECTIVE GROUNDING uuu
2. n u Yu 13 65 u 13 66 OTARTUPJINSTRUCTIONGS u u uu uu u p uu u u u ua Qi u aa 15 6 7 TOUCH PANEL 8 essere aaa 16 6 8 MICRO TITER PLATE CARRIAGE vba re ER Dr Ed Ua Rer E ar vd a e e te btt v 17 6 9 PLATE LOADING amp PIPETTING 18 6 10 u Z a a ae ite tee ete ed ee et eei 18 T PRECAUTIONS ERROR RR OR 19 8 PROGRAMMING 5 1 2 11 20 8 1 ABSORBANCE 0 00 0 e ease ea gessa ease sagesse as 20 8 2 23 RIORUM 24 8 4 REVERSE CUT OFF 37 8 5 MULTI STANDARDS 28 8 37 Version No 3 308 Page 2 of 84 Effective Date August 2009 User Manual readwell TOUCH 8 6 PERCENTAGE mea essa essssea seges ease 50
3. 50 8 8 KINETIC MODE OF 51 9 RECALLING AND RUNNING OF STORED TEST PROGRAMS 54 9 1 ABSORBANCE MODE out dds ar raras 55 CU OF wn 57 va aan Ass C UT OJ VA 59 9 3 MULTI STANDARD MODE 60 9A JnyghidassaymMiatusiqidayd Mode gt 64 10 RERUNNING ACCEPTED TESTS PROGRAMS 66 11 SAMPLE AND SAMPLE DUPLICATE erre nnne 68 12 PATIENT IDENTITY SAMPLE IDENTITY 2 2 2 2 70 13 SAVE PLATE AND SAVE 5 2 2 2 2 73 14 VIEWSTOREDDATA or U U 74 15 l 76 15 1 DATE AND TIME 76 15 2 PRINTER ON OFF SETTING e esesessa nannan nunna agas 76 5 3 yx u uy asa 77 15 4 PLATE SHAKING MODE SHAKER L ulu
4. Name HBSAG Pri 450 Sec 630 No of Smples 0 POS Cut Off DUP Y SIMUL Name HBSAG Pri 450 Sec 630 No of Smples 10 POS Cut Off DUP Y SIMUL Numeric Value 1 2 7 8 Name HBSAG Pri 450 Sec 630 No of Smples 10 DUP Y SIMUL 2 3 4 52 56 510 52 56 510 53 57 53 57 54 58 54 58 55 59 55 59 5 Cut Off 5 6 7 8 Same way you load the samples and Sample Duplicates in all other modes Version No 3 308 Effective Date August 2009 Page 69 of 84 User Manual readwell TOUCH 12 PATIENT IDENTITY SAMPLE IDENTITY ENTRY 12 1 To enter a patient ID for all samples there is option provided in loading screen shown as After entering number of samples either single or duplicate you select PID Name HBSAG Pri 450 Sec 630 POS Cut Off No of Smples 10 DUP N 1 B NC NC NC PC PC 51 52 SIMUL 2 3 4 5 6 7 53 54 55 56 57 58 59 510 PID KIRAN ABDUL MR JAME KRISHNA One by one you can enter name of each patient The character length of PID is only 7 characters NEXT and previous use to go to next screen in many numbers of samples 12 2 Sequential Patient ID Entry This one by one entry will take more time so we have provided one more option to enter patient Ids This option is SEQL sequential entry Suppose you are loading around 80 numbers of samples fo
5. 492 630 000 000 XXX YYY 5 According to the reagent manual change Blank NCs PCs to 5 for QC check Name HBSAG POS CutOff Pri 450 Sec 630 ESC NO Factor QCVal Mes Rem SAVE BL NC 1 000 PC 1 000 LC 1 000 CC 1 000 CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone QC3 N Cut off Index Y QC4 N Range Pos 0 000 Neg 0 000 6 Entry of Blank and Blank QC values Select BL to enter blank details Blank has to be always put in first wells if selected Name HBSAG POS CutOff Pri 450 Sec 630 ESC No Factor QCVal Mes Rem SAVE BL 0 000 0 000 NC 1 000 0 000 0 000 PC 1 000 0 000 0 000 LC 1 000 CC 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 Version No 3 308 Page 26 of 84 Effective Date August 2009 User Manual readwell TOUCH 7 After selecting BL below screen will come in the display 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 2 7 8 8 Enter the QC value of the blank by selecting the touch Zone Values of BL No of Blanks 1 000 Values Of BL lt 0 100 Numeric Value 1 2 7 8 9 Entry of Negative control and its QC values Select touch Zone Name HBSAG POS CutOff Pri 450 Sec 630 NO Factor QCVal Mes BL 0 100 1 000 1 00
6. Version No 3 308 Page 55 of 84 Effective Date August 2009 User Manual readwell TOUCH Details of absorbances of all well in table format for each strip will display in the screen as shown below Name ABSORBANCE Sec 630 Pri 405 ABS 1 0 125 0 125 5 7 0 125 0 125 5 5 2 0 250 0 250 5 3 0 350 0 350 NORM ABSORBANCE N BL ABS 4 0 450 0 450 ABS 5 0 550 0 550 SEND PLATE ABS 6 0 650 0 650 LOAD NEXT In this operation if you keep BLANK YES The first well of first strip will be consider as blank and instrument will gives the absorbances of remaining all well with blank subtraction from original absorbance The PRINT MATRIX will print the details of entire plate with well identification and absorbance of that well like A W1 W2 W3 W4 W5 W6 0 125 0 250 0 350 0 450 0 550 o 650 Using SEND PLATE plate data can be send to computer using either USB or SERIAL RS232 LOAD NEXT uses to get the absorbance of next plate Differential Absorbance Mode In differential absorbance mode the instrument will gives the absorbance difference each set of ODD number strip and EVEN number strip Name ABSORBANCE Sec 630 Pri 405 ABS 1 ABS 2 0 100 0 200 0 300 0 400 0 500 0 600 0 700 0 800 ABS 8 0 100 0 200 0 300 0 400 0 500 0 600 0 700 0 800 ABS 3 NORM ABSORB
7. 10 00 SAMP ABS AVG CONC REM 1 0 050 0 050 Bi NC PRINT SAVE PRINT RESULTS RESULTS MATRIX B In Multi standard or any calibrator mode Name TSH MULTI STANDARD Pri 450 Sec 630 Range High gt 16 61 Low 10 30 NXT HI CO High Low 0 000 LO CO High Low PREV NO SAMP ABS AVG CONC REM A1 B 0 050 0 050 SAVE B1 C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX OPT GRAPH TEST RESULTS If you select PLATE OPT you will get two options Select SAVE PLATE DATA which will save the entire 1 SAVE PLATE DATA plate information along with the control calibrator information You can save maximum TEN plates data 2 SEND PLATE DATA SEND PLATE is used to send the data from instrument to computer through USB or serial RS232 connection If you select SAVE RESULT option it will directly saves information of samples only except controls calibrators with test name patient ID and date Version No 3 308 Page 73 of 84 Effective Date August 2009 User Manual readwell TOUCH 14 VIEW STORED DATA You can view the stored plate or stored results by option View Plate available in MAIN MENU MAIN MENU 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial Communication When you will select the View Plate option it will show you the two options 1 PLATE RESULTS 2 PATIENT RE
8. High Low PREV NO SAMP ABS AVG CONC REM A1 B 0 050 0 050 SAVE B1 C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 Fi 51 0 200 0 200 2 100 1 G1 52 1 854 1 854 9 845 POS TSH 2 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX GRAPH TEST RESULTS Here you can get all the details in table format as per row and column shows in the screen You can get the print of same format by selecting option PRINT RESULTS To check the results of next samples you choose option NXT and then print it in format shown on screen by option Print Results Or you get 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 parameter in print matrix for a single well as follows ROW IDENTIFICATION B C D WELL NUMBER W1 W2 W3 WELL ID OR SAMPLE NUMBER B C1 C2 C3 OR S1 S2 S3 PATIENT IDENTIFICATION RAMESH VIKAS etc WELL ABSORBANCE 0 050 0 098 0 085 SAMPLE CONCENTRATION 0 738 0 689 2 578 INTERPRETATION REMARKS POS NEG EQ Version No 3 308 Page 63 of 84 Effective Date August 2009 User Manual readwell TOUCH 7 By selecting option View Graph key you can get graph on screen with all the details of X axis and Y axis You can get the graph print by selecting PRINT option Origin at X 0 000 0 000 X div 2 500 y d
9. NO Factor QCVal Mes 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 QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 After selecting the CUTABS below screen will come in the display Enter the equation as given in the reagent manual CUTABS CUT ABS 0 45 NC 0 35 PC 0 10 LC CC CF 3 4 5 9 0 Ln Version No 3 308 Page 30 of 84 Effective Date August 2009 User Manual readwell TOUCH Here Mean of NCs Factor X PC Mean of PCs Factor Y LC Mean of LCs Factor W CC Mean of CCs Factor Z CF Cut off factor Sqrt square root Lg LOG ALg Anti LOG Ln Natural LOG Aln Anti Natural LOG Abs any absolute value For Example A For equation CUT OFF ABS 0 45 0 35 PC 0 10 the formulae can be enter in two Ways 1 Enter the values as it is i e CUTABS 0 45 NC 0 35 PC 0 010 Keep the multiplication factors X Y W Z of controls NC PC CC and LC a constant number 01 Numbers mathematical functions and symbols for NC PC CC LPC can be select from the screen OR 2 second method the formulae can be enter 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
10. User Manual readwell TOUCH In such a case you can easily delete an individual control so that the mean of remaining controls will satisfy the QC condition of that control as per reagent manual To select any control for deleting you select touch zone shown in above screen When you select any particular control for deleting suppose you have selected Negative Control NC Here you will get a following screen which will show you which control is not satisfying the QC condition with or LO remark You can delete that particular control When you select that control a message will get display Select EDIT DEL key to proceed here select DEL key After deleting that control the absorbance of that control will become zero and the average of controls will also get changed Then select ESC key to come back NC VALUE 0 200 NC VALUE 0 200 NC1 0 150 NC1 0 150 NC2 0 350 NC2 0 350 HI NC3 0 200 NC3 0 200 NC3 0 200 HI Select EDIT DEL key to proceed When you will come back you will get the edited value for average of control with no remark for any control and no Invalid Assay message NOTE 1 In test with blank if blank do not satisfies the QC condition first make the blank absorbance valid and then if necessary valid the control absorbances This is because the absorbance of blank affect the absorbance of all controls and samples NOTE 2 It is recommended that for a test with s
11. W11 S81 OPD90 0 899 7 942 POS W11 582 OPD91 0 403 3 564 POS W11 583 OPD92 0 399 3 527 POS readwell TOUCH W12 584 OPD93 0 222 1 959 POS W12 585 OPD94 0 003 0 025 NEG W12 586 OPD95 2 638 23 30 POS W12 S87 OPD96 0 209 1 850 POS W12 S88 97 0 224 1 978 POS W12 589 OPD98 0 419 3 699 POS W12 S90 OPD99 2 579 22 78 POS W12 591 OPD100 0 015 0 132 NEG User Manual readwell TOUCH 8 4 Reverse Cut Off Mode For Reverse Cut Off mode select touch zone POS Cut off key It will changed to REV Cut Off Name REV CutOff Pri 450 Sec 0 ESC BL NC PC LC CC CU CU No Factor C QCVal Mes Rem SAVE Q N 1 000 N 1 000 N 1 000 N 1 000 N TFAC 0 000 TABS QC1 Interpretation QC2 Greyzone 96 Y 10 00 QC3 Cut off Index N Range In reverse Cut Off mode programming of test is same as Positive Cut off mode only QC check conditions for blanks and controls get reversed And in INTERPRETATION sample absorbance which are lesser than cut off absorbance gets remarked POSITIVE and sample absorbance higher than cut off absorbance gets remarked NEGATIVE this exactly opposite to normal POSITIVE Cut Off mode Same way it 8 5 Mu does the interpretation in case you select Cutoff Index Range Iti Standards Mode In this mode the instrument accepts a maximum of 12 calibrators and calculates concentration based on the best fit
12. positive 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 gt After entering all the parameter save the test by selecting SAVE option Name TSH MULTISTANDARD Pri 450 Sec 630 BL Y 0 000 CAL7 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High gt 25 03 Low lt 10 54 LO CO N High gt 16 61 Low lt 5 45 Interpretation Y Range High gt 15 25 Low lt 9 46 Same way you can make a test for Single standard Absorbance and uptake Version No 3 308 Page 47 of 84 Effective Date August 2009 User Manual readwell TOUCH 11 Example Print out obtained From readwell TOUCH MULTI STDS Name T4 Pri 450 Sec 630 BL N DUP N CAL 5 DUP Y Graph PT TO PT Y vs X ABS vs CONC HI CO N High gt Low LO CO N High Low lt Range Y High 6 000 Low lt 4 000 No Con Abs 1 0 000 0 000 2 1 500 0 000 3 2 500 0 000 4 4 500 0 000 5 10 00 0 000 Origin at x 0 000 y 0 000 x div 0 625 y div 0 126 2 526 2 27 2 021 1 76 1 51 1 26 1 01 0 75 0 50 0 25 0 00 0 000 2 500 5 000 7 500 10 0 T4 21 07 08 A W1 w2 w3 w4 w5 W6 w7 W8 w9 W10 W12 C1 c5 S4 S8 S12 S16 S20 S24 S28 S32 S36 S40 OP33 OP37 OP41 OP45 OP49 OP53 OP57 OP61 OP65 OP69 0 004 2 566 0 711 0 728 0 796 0 423 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
13. 1 023 2340 1 660 1 553 POS POS NEG EQ POS POS POS G W1 W2 W3 W4 W5 W6 WT S2 510 518 526 534 542 550 OPD11 OPD19 OPD27 OPD35 OPD43 OPD51 59 0 049 0 140 2595 0 138 0142 0 117 2 611 0 429 1234 22 92 1 215 1 252 1 035 23 06 NEG POS POS POS POS EQ POS W1 W2 W3 WA W5 W6 WT S3 S11 519 527 535 543 551 OPD12 OPD20 OPD28 OPD36 OPD44 OPD52 OPD60 0 061 0 109 0 002 0 071 0 076 0 131 0 109 0 538 0 964 0 018 0 631 0670 1 157 0 960 EQ NEG NEG NEG POS EQ Version No 3 308 Effective Date August 2009 W8 w9 W10 552 560 568 OPD61 OPD69 OPD77 0 072 0 400 1 454 0 636 3 533 12 84 NEG POS POS wa W10 S53 S61 S69 OPD62 OPD70 OPD78 0 115 2 5515 0 747 1 01 22 22 6 597 EQ POS POS W8 W9 W10 S54 S62 S70 OPD63 OPD71 OPD79 0 091 1 584 1 557 0 804 13 99 13 75 NEG POS POS W8 w9 W10 555 563 571 OPD64 OPD72 080 0 159 1 515 0 071 1 403 13 38 0 628 POS POS NEG W8 w9 W10 S56 564 572 OPD65 OPD73 0 081 0 156 0 080 2 616 1 377 0 705 23 11 POS NEG POS W8 w9 W10 557 565 S73 OPD66 OPD74 OPD82 0 052 2 638 0 855 0 460 23 30 7 548 NEG POS POS Ws w9 W10 S58 S66 574 OPD67 OPD75 OPD83 0 076 0 081 0 050 0 672 0 717 0 441 NEG W8 W9 W10 S59 S67 S75 OPD68 OPD76 OPD84 0 101 0 082 2 560 1 806 0 721 22 61 NEG POS Page 36 of 84 W11 S76 OPD85 0 743 6 564 POS W11 577 OPD86 0 748 6 608 POS W11 578 OPD87 0 502 4 434 POS W11 5 9 OPD88 0 423 3 732 POS W11 S80 OPD89 0 259 2 291 POS
14. 3 Utilities 4 View Plate 5 Serial Communication MAIN MENU TEST OPERATIONS 1 Select Test By Name 2 Select Test by Mode 3 Select Test by Number 4 List Tests 5 Add New Tests Test can be recall by Name Mode Number or by List test The entire saved test are available on first screen tests can be selected from this screen also READWELL TOUCH ABCDEFGHIJKLM Select Test 1 HBSAG 2 TSH 3 ABSORBANCE Version No 3 308 Effective Date August 2009 Page 54 of 84 01 01 08 MENU SEL PRNT NXT PREV DEL User Manual readwell TOUCH 9 1 Absorbance Mode Select the test by SEL option NORM ABSORBANCE Name ABSORBANCE BL N Pri 405 Sec 630 NORM MODE DIFF gt Below screen will appear on the display after selecting the Run display The instrument will ask Is Plate Loaded YES NO Press Yes Instrument will read the absorbances using mechanical plate movement After completion of reading it will ask Is Plate Removed YES NO Remove the plate and Select YES Name ABSORBANCE ABSORBANCE Name ABSORBANCE NORM ABSORBANCE Pri 405 Sec 630 BL N Pri 405 Sec 630 BL N ABS ABS ABS ABS ABS ABS ABS ABS ABS ABS ABS ABS 1 2 3 4 5 1 2 3 4 5 6 5 5 5 5 5 5 5 5 5 5 7 8 9 10 11 7 8 9 10 11 5 5 Is Plate Loaded Is Plate Removed NO NO ESC PRINTMATRIX SEND PLATE LOAD NEXT ESC PRINTMATRIX SEND PLATE LOAD NEXT
15. 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 mention above B If CUTOFF ABS NC 6 This can be entered as it is CUTABS NC PC 6 by keeping the multiplication factors X Y W Z of controls NC PC CC and LC a constant number 01 OR As you know in mathematics PC 6 NC 6 PC 6 1 6 NC 1 6 PC 0 166 NC 0 166 So you can enter same equation as CUT ABS NC by entering Multiplication Factor for NC X 0 166 multiplication factor for PC Y 0 166 This is because here NC Mean of NCs Factor X PC Mean of PCs Factor Y as mention above 17 QC1 QC2 QC3 amp QC4 can be used for any QC Checking of the test provided in reagent manual For example some kit manufacture may give QC check equation like PCx NCx 0 500 PC NC gt 15 etc This equation can be entered by selecting these QC options Select touch zone N It will become Y as shown in screen below By selecting touch zone 0 1 you enter QC equation Name HBSAG POS CutOff Pri 450 Sec 630 ESC C QCVal Mes Rem SAVE 0 100 Factor BL PC 1 000 LC 1 000 CC 1 000 CUTFAC 0 200 CUTABS 0 45 NC 0 35 0 10 Interpretation Greyzone 96 N Cut off Index Y Range 0 000 Neg 0 000 0 500 Q Y NC 1 000 Y
16. Calibrators Numerals will display on the bottom of the screen gt Select the number of calibrators User can select min 2 and Maxim 12 standard in this mode No Of Calibrator 2 Numeric Value 1 2 7 8 Version No 3 308 Page 40 of 84 Effective Date August 2009 User Manual readwell TOUCH Concentration Entry gt After entering the number of calibrators Concentration and absorbance column will come in 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 The concentration value should be either ascending or descending order No of Calibrator 7 1 2 3 4 5 6 7 Numeric Value 1 2 7 8 gt Programming Screen after Entry of standards Name TSH MULTISTANDARD Pri 450 Sec 630 BL Y 0 000 CAL 7 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low lt LO CO N High gt Low lt Interpretation N Range High gt Low lt Version No 3 308 Page 41 of 84 Effective Date August 2009 User Manual readwell TOUCH 7 Selection of Duplicate Blank and calibrators A For Duplicate Blank gt select the duplicate blank select touch zone DUP below the BLN Name MULTISTANDARD Pri 405 Sec 0 B
17. WB Wg W10 W11 Wiz 0 232 0 248 0 235 0 197 0 168 0 235 0 331 0 242 0 187 0 273 0 292 0 213 0 001 0 005 0 003 007 001 0 005 008 A005 0 006 0 002 D 03 02 000 Wi w3 Wit WS We W7 Wwe a W11 Wiz 0 258 0 215 0 224 0 221 0 213 0 240 0 173 0 203 0 195 0 199 0 210 0 172 0 001 0 0040 0 001 0 001 0 005 0 004 000i M002 000z O 002 0 002 0 002 0 001 0 0040 0 001 0 001 0 005 0 004 000i M002 0 002 O 002 0 002 0 002 Wi Wet WS We 7 We Wa W10 W11 Wiz 0 258 0 199 0249 0241 0 236 0 266 0 289 0 312 0 225 0 357 0 273 0 190 0 000 002 0001 0 001 0 000 0 007 0 004 0 005 1000 2 008 0 003 0 006 L002 M z 0 001 0 001 0 000 0 007 D 004 0 005 0 000 0 03 Wi w3 We 5 W WT WB wa 10 Wil Wiz 0 251 0 239 0 257 0 235 0 306 0 240 0 288 0 195 0 202 0 244 0 241 0 204 0 001 0 901 0 001 0001 012 0 000 0 016 0 001 0 002 0 000 0 000 0 001 0 9011 0 001 0001 0 012 0 000 0 016 2 001 0 000 0 002 0 000 0 000 Wi We Ws Wt WS We W7 WE wg Wo W11 Wiz 0 259 0 241 0 213 0 253 0 258 0 221 0 235 0 218 0 258 0 251 1 242 0 271 0 003 0 003 QuU60 O 003 0 001 002 0000 m i 002 0 001 0 003 0 003 QuU60 0 003 0 001 0 001 002 O 000 0 001 002 OT Version No 3 308 Page 53 of 84 Effective Date August 2009 User Manual readwell TOUCH 9 RECALLING AND RUNNING OF STORED TEST PROGRAMS 1 Test Operations 2 Technical Diagnosis
18. WT We W10 11 W12 56 513 521 529 837 545 553 SB1 569 577 585 OP2 14 OP222 230 OP238 OP246 OP254 262 2 OP278 OP286 OP284 0 415 0 152 0 358 2 408 0 064 1 408 2 524 0 125 2461 0 760 0 718 0 381 1 500 p 770 1 340 8 698 0 526 5 177 9 810 0 695 9 545 2 769 2 613 1 433 NEG NEG POS NEG EQ POS NEG POS NEG NEG NEG Wi Wa WA WS WE WT WB Wa Wid W11 W12 56 514 522 530 538 546 S54 562 570 578 586 OP215 OP223 OP231 239 OP247 OP255 OP263 OP271 OP2T78 OP287 295 0 823 2 505 0 115 0 153 0 418 0 177 1 926 0 214 1 530 1 490 0 412 2 594 3 000 10 15 0 665 0 771 1 511 0 838 7 308 0 841 5 651 5 483 1491 10 10 POS NEG NEG NEG POS NEG EQ EQ POS Wi We Wwe 5 WE Wr WB W11 W12 Sf 515 523 531 539 547 555 564 51 579 587 OP216 OP224 OP232 OP240 OP248 OP256 OP264 272 OP280 OP288 296 1 484 0 167 2615 0 152 2 632 0 492 0 192 0 336 1 468 0 506 0 428 0 214 3 500 0 811 10 19 0 768 10 26 1 783 0 880 1 281 5 403 1 834 1 547 0 941 NEG POS POS NEG NEG NEG EQ NEG NEG NEG E Wi We Wa WE wr WB wo Wid W11 W12 c5 58 516 524 532 540 548 555 564 572 580 588 OP225 233 OP214 OP249 OP257 OP285 OP273 OP281 OPZOT 2 570 0 164 0 173 0 125 0 166 0 168 2 543 0 523 1 631 2 642 0 258 0 250 10 00 0 803 0 826 0 695 0 807 0 812 10 31 1 898 amp 71 10 30 1 064 1 041 POS NEG POS POS NEG Wi Wa WS WT WB
19. Y 0 000 CAL7 DUP Y DUP Y Graph LINEAR Y vs X ABS vs CONC HI CO N High Low LO CO N High Low Interpretation N Range High gt Low lt 8 Linear mode and Point to Point mode There are two types of graphs in Multistandard 1 Linear LINEAR 2 Point to Point PT TO PT There are five types of scales for X and Y axis 1 LOGABS vs CONC X axis Concentration v s Y axis LOG of ABS 2 ABS vs LOGCONC X axis LOG of concentration v s Y axis Absorbance LOGITABS VS LOGCONC X axis 06 of concentration v s Y axis LOGIT of Absorbance ABS vs CONC X axis 2 Concentration v s Y axis 2 Absorbance LOGABS vs LOGCONC X axis of concentration v s Y axis LOG of absorbance e UJ Version No 3 308 Page 43 of 84 Effective Date August 2009 User Manual readwell TOUCH A Selection of Graph Select Graph type as per the details given in the reagent manual by selecting Touch Zone Graph Name MULTISTANDARD Pri 405 Sec 0 BLN CAL2 DUP N DUPN Graph LINEAR Y vs X ABS vs CONC HI CO N High Low lt LO CO N High gt Low lt Interpretation N Range High gt Low lt A Linear mode graph type gt After Selecting the Graph below screen will come in the display gt Select Graph type as Linear gt Select scale as per the details given in the reagent manual Graph LINEAR Y vs X ABS vs CONC TYPE SCALE LINEAR LOGABS vs CONG ABS vs LO
20. curve Graph is printed with Absorbance on Y axis and concentration on X axis Programming a new test 1 Select Main Menu Test Operation Add new test TEST OPERATIONS 1 Select Test By Name 2 Select Test by Mode 3 Select Test by Number 4 List Tests 5 Add New Test Version No 3 308 Page 37 of 84 Effective Date August 2009 User Manual readwell TOUCH 2 Select Touch Zone Multi Standard Select Test Mode 1 Absorbance 0 2 Single Standard 0 3 Cut off 0 4 Multi Standard 5 Percent Absorbance 6 Uptake 7 Kinetic After selecting the Multistandard mode below screen will come in the display Name MULTISTANDARD Pri 405 Sec 0 CAL 2 DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low LO CO N High Low Interpretation N Range High gt Low lt 3 Entry of Test Name gt Test Name can be entered by Selecting Touch Zone Procedure for entering the test name is same as that of cut off mode Refer Test Name entry in Cut off mode for further details Version No 3 308 Page 38 of 84 Effective Date August 2009 User Manual readwell TOUCH 4 Selection of Primary and secondary filters gt Select Touch Zone Name TSH MULTISTANDARD Pri 405 Sec 0 BL N CAL 2 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low lt LO CO N High gt Low lt Interpretation N Range High gt L
21. household bleach a 6 1 mixture is required This is a caustic solution It is important to wear gloves and eye protection when handling it Wipe down the carrier and all exposed surfaces of the unit with the bleach solution Remove the top shroud of the instrument and wipe down the top surface of the instrument base as well as the inside of the top shroud Reassemble the unit and discard the used gloves and towels Page 83 of 84 Effective Date August 2009 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 lt Position Dept Tel Country 1 Fax Post Code Model No Serial No Accessories Returned Date of Purchase if known Complaint Has the equipment been exposed to any of the following delete as applicable a Blood body fluids pathological specimens YES NO If YES please specify b Other Biohazard YES NO If YES Please specify Version No 3 308 Page 84 of 84 Effective Date August 2009
22. new calibrators and want the results of samples as per new graph select Load Calibrators YES If you 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 User Manual 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 instrument takes the average of it this is 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 HBSAG Pri 450 Sec 630 No of Smples 0 DUP N Name HBSAG Pri 450 Sec 630 No of Smples 0 DUP N Numeric Value 1 2 7 8 Name HBSAG Pri 450 Sec 630 No of Smples 10 DUP N 1 2 3 4 B 53 NC 54 NC S5 56 57 58 51 59 52 510 Version No 3 308 Effective Date August 2009 POS Cut Off SIMUL POS Cut Off SIMUL POS Cut Off SIMUL 5 6 7 8 68 0184 readwell TOUCH User Manual readwell TOUCH If you want to load duplicate samples select DUP key it will changed from N to Y After this enter number of samples by selecting No of Samples
23. of test parameters A screen will come as follows Name HBSAG POS Cut Off Pri 450 Sec 630 No of Samples 0 DUP N SIMUL 2 It shows the 12 strips horizontal with 8 wells vertical with blanks and controls loaded in first strip You enter no of samples by selecting that option and enter no of samples you want to load In case of 10 samples Name HBSAG POS Cut Off Pri 450 Sec 630 No of Samples 10 DUP N SIMUL Version No 3 308 Page 57 of 84 Effective Date August 2009 User Manual readwell TOUCH 3 After entering No of samples press RUN The plate loading tray will come out and a message will appear Is plate loaded YES NO Name HBSAG Pri 450 Sec 630 POS Cut Off No of Samples 10 DUP N SIMUL 2 53 54 55 56 57 58 59 510 Is Plate Loaded 4 Here you load the plate in the direction that controls should go in first And press YES The instrument will read the controls and samples and then it will bring the tray out This time a message will come Is plate removed YES NO You remove the tray and press YES Name HBSAG Pri 450 Sec 630 POS Cut Off No of Samples 10 DUP N SIMUL 1 2 3 4 5 6 7 B 53 NC 54 NC 55 56 57 58 51 59 52 510 Is Plate Removed 5 After pressing YES result screen will come where you will get the measured values of mean blank mean of all controls cut off absorbance Name HBSAG POS Cut O
24. readwell TOUCH is user friendly micro plate Analyser It is designed to measure and interpret enzyme immunoassay results both monochromatically and bichromatically lt is intended for in vitro diagnostic use 3 2 Special Features e The readwell TOUCH can accommodate a flat as well as a round bottom well 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 e The readwell TOUCH operates on a WIDE voltage 90 270 volts This eliminates the need for an external voltage stabilizer e The Feadwell TOUCH has a special provision which allows it to be used even when a printer is not available Readings can be conveniently noted down manually The detailed results available on screen Following are the other special features of readwell TOUCH o Option of Lamp saving mode o Selection of both primary and secondary filters o Latest technology with battery back up for 250 tests with QC more than 2500 result o Robust in built 52 column thermal printer with 384 stationary heads o Unique circuitry for long lamp life o Alphanumeric Patients ID entry o Editing of saved tests o Human machine user interface Touch panel Keypad o Multi standard curve up to 12 standard calibrations with one blank optional o Access
25. to test by touch of key o Capability to connect to 80 column printer for direct report printout o Blank is optional o Setting of the Date and Time o Capable of storing deleting and recalling tests o Multiple calibrator modes o Selection of duplicates for both calibrators and samples o Extensive software for cut off mode o Selection of Positive Equivocal Negative cut off o Several pre programmed calculation modes help to facilitate data processing of enzyme immunoassays These are menu driven modes for simple and error free operations v ABSORBANCE MODE v CUT OFF MODE v MULTISTANDARD MODE v SINGLE STANDARD MODE v ABSORBANCE MODE v UPTAKE v KINETIC Version No 3 308 Page 7 of 84 Effective Date August 2009 User Manual readwell TOUCH 3 3 Technical Specification of readwell TOUCH Human Machine Interface TOUCH PANEL KEYPAD 0 000 to 3 500 Absorbance Units A Photometric Accuracy 2 or 0 007 whichever is higher from 0 to 1 5 A 3 1 5 Ato 3 5 Dit Photometric Linearity Optical measurement 8 Channel Filters Type of filter Narrow band Interference Wave Length 405nm 450nm 492nm 630nm amp Four Optional Half Bandwidth 10nm 2nm Selection Automatic by Stepper Motor Light Source Tungsten halogen lamp 20 Watts Display 6 Graphics LCD Negative Blue STN Curve Plotting Graphical Representation on Printer Plate Carrier Movement Precisely through the step
26. which you loading in single plate For first batch the PID are from HIV 1 to HIV 30 for second batch PIDs are from HIV 51 to HIV 75 and the third batch has PIDs from HIV 91 to HIV 105 To enter these PIDs you have to enter sequential entries three times use following steps 12 3 Select SEQL Enter alphabet HIV Enter initial well number 1 and the last well number 30 after this enter initial PID number 1 It will load PIDs for first 30 samples from HIV 1 to HIV 30 12 4 To enter next sequence again select SEQL enter alphabet HIV Enter initial well number 31 and last well number 55 After this enter initial PID number 51 It will load PIDs for next 25 samples from HIV 51 to HIV 75 12 5 To enter next sequence again select SEQL enter alphabet HIV Enter initial well number 56 and last well number 70 After this enter initial PID number 91 It will load PIDs for next 15 samples from HIV 91 to HIV 105 In this way you can select any sequence for any well locations The entered PID get stored in instrument memory until you delete it by using option Delete previous PIDs Yes NO Version No 3 308 Page 72 of 84 Effective Date August 2009 User Manual readwell TOUCH 13 SAVE PLATE AND SAVE RESULTS In all modes of operation there are two options provided to stored results A In cut Off mode Name HBSAG POS Cut Off Pri 450 Sec 630 BL 1 Range PERCENTAGE
27. 0 1 000 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone QC3 Cut off Index Y QC4 Range Pos 0 000 Neg 0 000 Version No 3 308 Page 27 of 84 Effective Date August 2009 User Manual readwell TOUCH 10 Enter no of Negative control 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 X No of NC s 3 Values of X 1 000 Value of NC lt 0 150 Numeric Value 1 2 7 8 manual by selecting Zone Values Of 11 After the entry of no of NCs Select ESC The below screen will come in the display Name HBSAG Pri 450 Sec 630 No Factor BL 1 000 1 000 1 000 1 000 CUTFAC 0 000 CUTABS QC1 QC2 QC3 QC4 12 Entry of positive Controls PC gt Select touch Zone Name HBSAG Pri 450 Sec 630 No Factor 1 000 1 000 1 000 1 000 CUTFAC 0 000 CUTABS QC1 QC2 QC3 4 Version No 3 308 Effective Date August 2009 POS CutOff QCVal Mes Rem 0 100 0 150 Interpretation Greyzone N Cut off Index Y Range Pos 0 000 Neg 0 000 POS CutOff QCVal Mes Rem 0 100 0 150 Interpretation Greyzone N Cut off Index Y Range Pos 0 000 Neg 0 000 Page 28 of 84 User Manual readwell TOUCH 13 After selecting PC below screen will come in
28. 0 002 0 010 0 035 0 056 0 001 these are D M values of each sample W3 W4 WS W6 0 100 1 200 0 200 2 600 0 800 0 028 0 037 0 050 0 034 0 045 0 056 0 075 0 100 0 068 0 090 Using SEND PLATE you can send plate data to computer using either USB or SERIAL RS232 LOAD NEXT uses to get the absorbance of next plate Version No 3 308 Effective Date August 2009 Page 52 of 84 User Manual readwell TOUCH 13 Example Print out obtained From readwell TOUCH KINETIC Name KINETIC 1 Pri 405 Sec 630 Read Timer 5 min Read Period 60 sec KINETIC 1 12 9 09 16 28 27 w3 Wt 5 W WT WB Wa 10 W11 Wiz 0 303 0 373 0 249 0 270 0 306 0 294 0 251 0 242 0 234 0 258 0 251 0 242 0 000 002 0 004 0 006 0 002 0 012 000S 0009 0 000 0 008 0 002 Q DQU 0 000 002 004 06 0002 0 013 0005 0TA 0 000 0 008 0002 0 000 B W1 Wz Wt WS We WT Wu W1 W11 WiZ 0 250 0 225 0 272 0 378 0 233 0 287 0 278 0 260 0 253 0 220 270 0 275 M003 0 0015 0 000 0 001 0 003 0 000 Q 014 0001 000 0 001 0000 M002 0 002 0 005 0 000 0 001 0 003 0 0900 Q 814 0 01 000 0 001 0000 C Wi W2 Ws Wit WS We W7 Wwe Wa W11 Wiz 0 243 0 217 0 195 0 203 0 254 0 209 0 244 0 206 0 338 0 280 0 295 0 251 0 002 00 000 2 002 0 000 001 0 000 2004 P tt Lii 0001 02004 0 002 M000 0 002 0 00 001 0 000 000i 0 006 D W1 w3 We WS We WT
29. 0 150 Y N N Version No 3 308 Page 31 of 84 Effective Date August 2009 User Manual readwell TOUCH Enter equation of and value of QC check Select touch zone Value and equat Enter QC Value and Equation Enter QC Value and Equation QC1 Value 0 500 QC1 Value 0 000 QC1 Equat QC1 Equat QC Equat PC NC Numeric Value 1 2 6 ENTER 7 8 CLEAR Same way you can enter QC equations for QC2 QC3 and 0 4 NOTE 1 On screen it is mention that gt Y it is not necessary any reagent manual they always mention QC value should be greater than some constant value There may be chance that they will mention QC value should be less than some constant value In such a case you can change the symbol from QC1 gt Y to QC1 lt Y only by selecting a symbol of comparison 2 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 3 308 Page 32 of 84 Effective Date August 2009 User Manual readwell TOUCH 18 Interpretation of samples Now enter RANGE for interpretation of results either in percentage Greyzone or positive and negative values of INDEX a ratio of Sample Abs Cutoff Abs If Cutoff Index range or Greyzone not mention do not enter any values Instrument will do the interpretation with references to the Cut off absorbance 18 1 Interpretatio
30. 1 07 08 A W1 W2 WA W5 W6 W8 W9 W10 W11 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 W1 W2 WA W5 W6 W7 w8 w9 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 C W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 0 065 2596 0 135 0 142 0 141 0 182 0 108 0 112 1 585 1 530 0405 2 635 D W1 W2 W3 WA W5 W6 W8 w9 W10 W11 W12 0 072 0 150 2 630 0 143 2 650 0 077 0 159 0 170 1 504 0 071 0 426 0 222 E W1 W2 W3 WA W5 W6 WT W8 w9 W10 W11 W12 2 541 0 140 0 149 0091 0 166 0 173 2 653 0 191 0097 2659 0 252 0 222 F W1 W2 W3 WA W5 W6 W8 W9 W10 W11 W12 2 614 2 682 0 185 0 130 2648 0 167 0 176 0 071 2 686 0 853 0 907 0 426 G W1 W2 W3 W4 W5 W6 W8 w9 W10 W11 W12 0 056 0 163 2 571 0155 0 147 0119 2618 0 081 0 085 0 070 0407 2 591 H W1 W2 WA W5 W6 w8 w9 W10 W11 W12 0 071 0 123 0 113 0 054 0 116 0 060 0 112 0 111 0 093 2 568 0 396 0 015 Version No 3 308 Page 22 of 84 Effective Date August 2009 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 0 A single calibrator standard of a known concentration is used to calibrate the instrument so that the concentration of unknown samples can be calculated according to Beer s Law The absorbances are read at user selected
31. 527 2 141 0 475 NEG NEG NEG NEG NEG NEG NEG NEG NEG NEG B W1 2 w3 W4 w5 W6 W7 W8 W9 W10 W11 W12 5 5 5 5 5 5 5 5 5 5 0 017 2 485 1 432 1 448 1 412 0 755 0 709 0 756 0 729 0 173 0 700 0 134 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 C W1 w2 w3 W4 w5 W6 ws w9 W10 W11 W12 C2 S1 S5 S9 13 517 521 525 529 533 537 541 0 OP34 OP38 OP42 OP46 50 54 OP58 OP62 OP66 OP70 0 413 2 603 0 081 0 801 0 154 0 448 0 155 0 161 2 547 0 766 0 854 2 625 1 500 10 43 0 273 2 382 0 516 1 963 0 523 0 533 10 30 2 340 2 444 10 43 POS NEG NEG NEG NEG NEG NEG POS NEG NEG POS D W1 w2 w3 4 5 W6 W7 ws w9 W10 W11 W12 C S S S S S S S S S S S 0 442 2 609 0 092 0 804 0 153 0 800 0 156 0 157 2 615 0 803 0 803 2 589 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 E W1 w2 w3 W4 w5 W6 W7 ws w9 W10 W12 C3 S2 S6 S10 514 518 522 526 530 534 538 542 OP31 OP35 OP39 OP43 OP47 OP51 OP55 OP59 OP63 OP67 Op71 0 823 1 520 0 155 0 846 0 154 2 616 0 531 0 454 0 448 2 386 1 542 1 431 2 500 4 772 0 532 2 600 0 532 7 579 1 547 1 487 1 539 11 15 4 738 4 386 EQ NEG NEG NEG POS NEG NEG NEG POS EQ EQ W1 w2 w3 w4 w5 W6 W7 W8 w9 W10 W11 W12 5 5 5 5 5 5 5 5 5 5 5 0 882 1 584 0 161 0 924 0 162 1 533 0 363 0 393 0 440 3 096 1 549 1 497 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 G W1 2 w3 WA4 W6 W7 W8 w9 W10 W12 C4 S3 S7 511 515 519 523 527 531 535
32. 539 543 OP32 OP36 OP40 OP44 OP48 OP52 OP56 OP60 OP64 OP68 OP72 1 463 1 490 1 419 1 410 0 149 1 456 0 159 2 447 2 637 1 415 1 454 1 453 4 500 4 478 4 337 4 393 0 520 7 114 0 510 9 689 10 24 4 293 4 376 4 442 EQ EQ EQ NEG POS NEG POS POS EQ EQ EQ H 2 w3 W4 5 W6 W7 ws W9 W10 W11 W12 5 5 5 5 5 5 5 5 5 5 5 1 539 1 498 1 478 1 524 0 161 2 520 0 146 2 489 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 0 000 Version No 3 308 Page 48 of 84 Effective Date August 2009 User Manual readwell TOUCH 12 Example Print out obtained From readwell TOUCH MULTI STDS Name T4 Pri 450 Sec 630 BL N DUP CAL 5 DUP N Graph PT TO PT Yvs X ABS vs CONC HI CO N High gt Low lt LO CO N High Low lt Range Y High gt 6 000 Low 4 000 No Con Abs 1 0 500 0 083 2 1 500 0 425 3 3 000 0 834 4 5 500 1 497 5 10 00 2 569 Origin at x 0 000 y 0 000 x div 0 625 y div 0 128 2570 2 31 2 056 1 79 1 542 1 28 1 028 0 771 0 514 0 257 0 00 2550 5000 7 500 100 T4 21 07 08 We Wid WS WE Wr Wo Wid W11 W12 C1 54 512 520 528 S36 44 562 S60 558 576 584 213 221 OP229 OP237 OP245 OP253 269 OP2T77 OP285 293 0 055 0 138 0 091 2571 0 085 0 125 0 362 0 095 0 402 1 392 0 724 0 229 0 500 0 734 0 601 10 00 0 582 0 694 1 352 D 610 1 462 5 119 2 635 0 984 NEG NEG POS NEG NEG NEG NEG NEG EQ NEG NEG B Wi We w3 W4 WS WE
33. ANCE BL N ABS 4 0 900 1 000 1 100 1 200 1 300 1 400 1 500 1 600 ABS 10 0 900 1 000 1 100 1 200 1 300 1 400 1 500 1 600 ABS 5 PRINTMATRIX SEND PLATE Version No 3 308 Effective Date August 2009 ABS 6 1 700 1 800 1 900 2 000 2 100 2 200 2 300 2 400 ABS 12 1 700 1 800 1 900 2 000 2 100 2 200 2 300 2 400 LOAD NEXT Page 56 of 84 It is showing the absorbances only for even number strips This absorbance values are actually differences between each well of strip 1 and well of strip 2 You can get the difference between set of 1 2 3 4 5 6 7 8 9 10 and 11 12 It is not possible to change this combination In PRINT MATRIX you will get the print of entire plate data with actual absorbance of each well and difference of absorbance between ODD well and EVEN well like A W1 W2 W3 W4 W5 W6 0 200 0 100 1 200 0 300 2 600 0 900 0 000 0 100 0 000 0 900 0 000 1 700 W1 W2 W4 WS W6 0 300 0 100 1 200 0 200 2 600 0 000 0 200 0 000 1 000 0 000 User Manual readwell TOUCH 9 2 Cut off Mode Name HBSAG POS Cut Off Pri 450 Sec 630 ESC C QCVal Mes Rem SAVE Factor Q Y 0 100 1 000 Y 0 150 1 000 Y 0 500 1 000 N 1 000 N CUTFAC 0 200 CUTABS 0 45 0 35 PC 0 10 Interpretation Greyzone 96 N Cut off Index Y Range Pos 0 000 Neg 0 000 1 You can run this test by selecting RUN option PRINT is used to print the details
34. C A1 B 0 050 0 050 SAVE B1 C1 0 070 0 70 0 000 RESULT C1 C2 0 257 0 257 2 500 Fi 51 0 200 0 200 2 100 TSH 1 G1 52 1 854 1 854 9 845 POS TSH 2 LOAD PRINT PLATE VIEW ACCEPT PRINT NXT MATRIX GRAPH TEST RESULTS Version No 3 308 Page 66 of 84 Effective Date August 2009 User Manual readwell TOUCH When you want to run such a accepted test after selecting RUN option in test detail screen In OFF mode Name HBSAG Pri 450 Sec 630 POS Cut Off No of Samples 0 DUP N SIMUL Load Blank Name HBSAG Pri 450 Sec 630 POS Cut Off No of Samples 0 DUP N SIMUL Load Controls This time it will not load the blank and controls directly It will ask 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 graph of controls select so that you can run only samples to get their results without loading control and calibrators If you want to load only Blank select Load Blank YES and Load Controls NO 2 In Multi Standard Single Standard Absorbance Uptake Mode Name HBSAG Pri 450 Sec 630 POS Cut Off No of Samples 0 DUP N SIMUL Load Calibrators Version No 3 308 Effective Date August 2009 Page 67 of 84 In Calibrator Mode after asking Load Blank Yes No it will ask Load Calibrators Yes No If you are loading
35. CONC HI CO N High gt 25 03 Low lt 10 54 LO CO N High Low Interpretation N Range High gt Low lt B For Low control select zone LO CO N It will ask Low Control Required Yes No Select YES Name MULTISTANDARD Pri 405 Sec 0 BLN CAL2 DUP N DUPN Graph LINEAR Y vs X ABS vs CONC HI CO High gt 25 03 Low lt 10 54 LO CO N High Low Interpretation N Range High gt Low lt Low Control Required gt Enter the range High and Low as per the reagent manual High gt 16 61 Low lt 5 45 Numeric Value 1 2 7 8 Version No 3 308 Page 46 of 84 Effective Date August 2009 User Manual readwell TOUCH 10 Normal Range selection for interpretation of samples For interpretation of specimen result POSITIVE or NEGATIVE enter normal range given in REAGENT MANUAL Select key Interpretation N It will become Interpretation Y Then select key HIGH gt and LOW lt to enter normal range Name MULTISTANDARD Pri 0 Sec 0 BLN CAL2 DUP N DUPN Graph LINEAR Y vs X ABS vs CONC HI CO N High gt 25 03 Low lt 10 54 LO CO N High gt 16 61 Low lt 5 45 Interpretation N Range High gt Low lt gt Enter Normal Range for positive and negative samples Enter HIGH Range value High gt 15 25 Low lt 9 46 Numeric Value 1 2 7 8 All the results whose concentration is coming above the High Range will considered
36. EAR You can easily select any particular calibrator by touching that touch zone and edit the absorbance of that After editing the calibrator s absorbance select ESC A message will come PLEASE WAIT and you will get the modified graph NOTE SAME PROCEDURE YOU CAN USE TO CREATE AND RUN THE TEST ALL OTHER MODES LIKE SINGLE STANDARD ABSORBANCE AND UPTAKE Version No 3 308 Page 65 of 84 Effective Date August 2009 User Manual readwell TOUCH 10 RERUNNING ACCEPTED TESTS PROGRAMS We know ACCEPT TEST option is used to store the data of controls or calibrators refer chapter 9 2 7 page 59 and 9 3 7 page 64 After running any test first time with controls or calibrators you select option Accept Test to save the data of controls or calibrators so that next time when you want to load the same test there is no need to load controls or calibrators in ELISA plate You can use previously stored data 1 In OFF Mode Name HBSAG POS Cut Off Pri 450 Sec 630 ESC C QCVal ACCEPT NO Factor Q BL 1 Y 0 100 TEST NC 3 1 000 Y 0 150 PC 2 0 100 Y 0 500 PRINT LC 0 1 000 CC 0 1 000 CUTFAC 0 200 CUTABS 0 563 Display VALUE QC1 2 560 QC2 QC3 4 LOAD NEXT Range 96 10 00 2 In Multi standard Mode Name TSH MULTI STANDARD ESC Pri 450 Sec 630 BLY CAL7 Range High gt 16 61 Low 10 30 NXT HI CO High Low 0 000 LO CO High Low PREV NO SAMP ABS AVG CON
37. For Example To activate the selection e oenter the primary filter value touch any point in the shaded area Pri on the LCD screen On proper selection the analyser responds with blinking of the parameter text and also the TOUCH ZONE and a submenu is displayed e oenter Test Name Touching the Name touch zone provides an alphanumeric screen Enter the Test name by touching the Touch zone of that variable The selected value blinks and is displayed next to the parameter Selection Indicator Selected onscreen 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 3 308 Page 16 of 84 Effective Date August 2009 User Manual readwell TOUCH 6 8 Micro Titer Plate Carriage I SEG mood gt SD IST Plate movement Direction Reading Direction Plate Carrier 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 the each well of plate exactly below the optical path of each channel The plate carrier is moved by a well controlled stepper motor drive Version No 3 308 Page 17 of 84 Effective Date August 2009 User Manual readwell TOUCH 6 9 Plate Loading amp Pipetting Procedure Control and sample pipetting procedure in case of cut off Maximum numb
38. GCONC PT TO PT LOGITABS vs LOGCONC ABS vs CONC LOGABS vs LOGCONC B Point to Point Graph Type Select touch zone PT to PT abs scale of graph ABS vs CONC Graph Type PT TO PT Y vs X ABS vs CONC TYPE SCALE LINEAR LOGABS vs CONG ABS vs LOGCONC EST OPI LOGITABS vs LOGCONC ABS vs CONC LOGABS vs LOGCONC Version No 3 308 Page 44 of 84 Effective Date August 2009 User Manual readwell TOUCH Select the scale type touching the required zone Name MULTISTANDARD Pri 405 Sec 0 BL N CAL 2 DUPN DUP N Graph PT TO PT Y vs X ABS vs CONC HI CO N High Low lt LO CO N High gt Low lt Interpretation N Range High gt Low lt 9 Selection of Controls A For High control select zone HI CO N It will ask High Control Required Yes No Select YES and then enter range of control HIGH and LOW Name MULTISTANDARD Pri 405 Sec 0 BL N CAL2 ESC DUP N DUP N SAVE Graph LINEAR Y vs X ABS vs CONC HI CO N High Low LO CO N High Low Interpretation N Range High gt Low lt High Control Required Enter range of control HIGH and LOW as per reagent manual Enter High Range Value High 25 03 Low 10 54 Numeric Value 1 2 7 8 Version No 3 308 Page 45 of 84 Effective Date August 2009 User Manual readwell TOUCH Name MULTISTANDARD Pri 405 Sec 0 BLN CAL2 DUP N DUPN Graph LINEAR Y vs X ABS vs
39. H For row entry select ROW key and enter row position Please Enter Row Entry 1 Row Entry B C D E GH 4 You locate controls from first well of 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 3 row B for second HI control then the location of HI control will be display on screen As shown in screen below Name TSH MULTISTANDARD Pri 450 Sec 630 No of samples 0 DUP N SIMUL 5 Now you select no of samples you want to run If you have 12 samples Then the screen will appear Name TSH MULTISTANDARD Pri 450 Sec 630 No of samples 12 SIMUL 3 4 5 6 7 8 9 10 58 59 510 511 512 Version No 3 308 Page 62 of 84 Effective Date August 2009 User Manual readwell TOUCH 6 THEN YOU PRESS RUN TO START THE READING OPERATION The tray will come out A message will come Is Plate loaded YES NO Here you load the tray in a direction that calibrators should go in first and press YES The instrument will read the absorbance of calibrators and samples After reading a message will come Is plate removed YES NO You remove the tray and press YES The Tray holder will go inside and a screen will come which gives details of all calibrators samples and controls Name TSH MULTI STANDARD ESC Pri 450 Sec 630 BLY CAL7 Range High gt 16 61 Low 10 30 NXT HI CO High Low 0 000 LO CO
40. H VERSION NUMBER CLINIC NAME CURRENT DATE WITH TIME READWELL TOUCH Clinic name Serial Number Select Test 1 HBSAG 6 HIV 2 HCV 7 IGM 3 T3 8 4 4 TSH 5 HIV User can select a saved test by first touching the required TEST NAME on the screen and then touch the SEL option to carry out further operation on the test DEL Deletes the selected test If the number of tests is more than 10 NEXT can be used for browsing through the list pages PRINT For printing the test screen MENU used to select Main menu screen Version No 3 308 Page 15 of 84 Effective Date August 2009 User Manual readwell TOUCH 6 7 Touch Panel Check readwell TOUCH provides a Touch sensitive LCD panel and KEYPAD for easy user interface The Menus are displayed the text of the parameter forms the TOUCH ZONE Touch screen Layout Name POS CutOff Pri 405 Sec 0 ESC EDIT No Factor QC QCVal Mes Rem RUN BL N NC 1 000 N PC 1 000 LC 1 000 N GC 1 000 N CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone QC3 Cut off Index Y 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 and rest of the Touch Zone is deactivated
41. L Y 0 000 CAL7 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low lt LO CO N High Low Interpretation N Range High gt Low lt gt After selecting DUP instrument will display message Duplicate Blank Yes No as shown below Select Yes for Duplication of Blank Name MULTISTANDARD Pri 405 Sec 0 BL Y 0 000 CAL7 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low LO CO N High Low Interpretation N Range High gt Low lt Duplicate Blank B For Duplicate Calibrators gt Toselect Duplicate Calibrator select Touch Zone DUP below the CAL 7 Name MULTISTANDARD Pri 405 Sec 0 BL Y 0 000 CAL7 DUP Y DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low LO CO N High Low Interpretation N Range High Low lt Version No 3 308 Page 42 of 84 Effective Date August 2009 User Manual readwell TOUCH gt After selecting DUP instrument will display message Duplicate Calibrator Yes No as shown below Select Yes for Duplication of calibrator Name MULTISTANDARD Pri 405 Sec 0 BL Y 0 000 CAL7 DUP Y DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low lt LO CO N High gt Low lt Interpretation N Range High gt Low lt Duplicate Calibrator gt Screen after standard entry amp selection of duplicate Blank amp Calibrators Name MULTISTANDARD Pri 405 Sec 0 BL
42. O 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 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 2 Check Light Path CH x Where x is any channel number X 1 2 3 4 5 6 7 8 5 Check USB Application on 6 Filter Movement Error 7 Plate Movement Error Version No 3 308 Page 82 of 84 Effective Date August 2009 User Manual readwell TO
43. SULTS 1 PLATE RESULTS will show you the details of stored plate last 10 plate with date Test name and mode of operation in descending order from last to first You can select any test the instrument will show you the full plate information along with controls calibrators in table format HBSAG 02 01 08 DATE TEST MODE ESC CUT ABS 0 300 02 01 08 HBSAG NO SAMP ABS AVG RES REM PID 01 01 08 TSH M SEL 30 12 07 HIV C 28 12 07 HIV C ESC NEXT PREV PRINTMATRIX SENDDATA PRINT Print Matrix will print the details of entire plate in matrix format as explain earlier Print will print only the data displayed on screen Send data is used to send the data from instrument to computer through USB or serial RS232 connection Version No 3 308 Page 74 of 84 Effective Date August 2009 User Manual readwell TOUCH 2 PATIENT RESULTS will show the details of all samples saved in memory using option SAVE RESULTS all different modes as explain earlier This option will display the data in table format as shown below You will get the Test name Mode of test operation result of sample PID and Remark The instrument has a memory to stored 2500 sample results This option not shows the information of controls or calibrators 01 01 08 Test Mode Hesult Remarks ESC NEXT PREV PRINT PRINT is used to print the details as available on display screen NEXT and PREV option is used to go to next page of sample d
44. Test Name NORM ABSORBANCE NORM ABSORBANCE Name BL N ESC ABS 450 Pri 405 Sec 0 D NORM T MODE DIFF Version No 3 308 Page 20 of 84 Effective Date August 2009 User Manual readwell TOUCH 5 Select primary and secondary filter Pri 450 Sec 630 Select Filter Val 0 405 450 492 630 000 000 XXX YYY 6 If Blank is required select BL NORM ABSORBANCE MEN Name ABSORBANCE If you select BL Y it will read first BL Y well of first strip A1 as a blank and subtract the absorbance of blank well 405 8 0 from all other well s absorbance NORM MODE DIFF 7 In absorbance mode there are two modes of operations a Normal Absorbance Mode Instrument gives the absorbance of each and every well Select touch zone NORM b 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 1 In Normal Mode 2 In Differential Mode NORM ABSORBANCE DIFF ABSORBANCE Name ABSORBANCE Name ABSORBANCE BL N ESC BL N Pri 405 Sec 630 Pri 405 Sec 630 NORM NORM MODE MODE DIFF DIFF Version No 3 308 Page 21 of 84 Effective Date August 2009 User Manual readwell TOUCH 9 Example Print out obtained From readwell TOUCH NORM ABSORBANCE Name HCV BL N Pri 450 Sec 630 HCV 2
45. 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 109C and 409C Version No 3 308 Page 9 of 84 Effective Date August 2009 User Manual readwell TOUCH 5 INSTRUMENT DESCRIPTION 5 1 Instrument Working Principle e Switch on and program the instrument e Place the plate firmly onto the carriage e 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 e 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 instrume
46. UCH 19 DECONTAMINATION 19 1 19 2 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 Purpose of Decontamination Decontamination minimizes the risk to all who come in contact with the instrument during shipping handling and servicing 19 3 19 4 Version No 3 308 General Considerations Any laboratory instrument that has been used for clinical analysis is considered a biohazard and should be decontaminated prior to handling Intact skin is generally considered an effective barrier against infectious Organisms however small abrasions and cuts may not be always being visible Prophylactic gloves must be worn when handling instruments that have not been decontaminated Gloved hands should be considered contaminated at all times and must be kept away from eyes mouth and nose at all times Mucous membranes are considered prime entry routes for infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols Eating and drinking while decontaminating instruments is not advisable Procedure A solution of 5 Sodium Hypo Chlorite NaOCL solution Bleach is used Commercial bleach is 5 NaOCL household bleach is 3 NaOCL When using commercial bleach use a 10 1 mixture if using
47. User Manual readwell TOUCH readwell TOUCH ELISA Plate Analyser User Manual Version 3 308 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 robonikindia com Version No 3 308 Page 1 of 84 Effective Date August 2009 User Manual readwell TOUCH TABLE OF CONTENTS 1 GENERAL 4 4 1 1 WARRANTY INFORMATION ccceccccecceccccccccccccceccacccccceaceneaccaceneaceneateceeneateneauenesneaeentass 4 1 0 TECHNICA SERVICE 4 1 3 DISPOSALINSTRUGTION u u u 4 Wie CONTAC 4 2 GENERAL SAFETY WARNINGS J eee ee ees 5 2 1 DANGER WARNINGS SYMBOLS 5 2 2 6 3 INTRODUCTION 7 3 1 DESCRIPTION Z eres acter arte ete E EE 7 9o 2 2
48. anty 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 warranty does not include any responsibility for direct or indirect personal and material damages caused by improper use or maintenance of the instrument Parts that are inherently subject to deterioration are excluded from the warranty In case of defects due to misuse of the instrument any travel and man hour expenses will be charged extra 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 etc 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 fix the instrument the user as described in this manual should carry out ordinary maintenance ROBONIK technical service or an authorized service center with specialized technicians with suitable instrumentation and original spare parts only are always available for extraordinary maintenance repair under a yearly maintena
49. centration of calibrator Name TSH ABSORBANCE Pri 450 Sec 630 BL Y 0 000 CAL1 ESC DUP N DUP N SAVE HI CO N LO CO N Interpretation N Range 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 0 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 TSH UPTAKE Pri 450 Sec 630 BL Y 0 000 CAL1 ESC DUP N DUP N SAVE HI CO N LO CO Interpretation N Range gt Please refer single standard for parameter entry Version No 3 308 Page 50 of 84 Effective Date August 2009 User Manual 8 8 Kinetic mode of Operation To create a new test in KINETIC mode KINETIC Name KINETIC Pri 405 5 0 Read Time 1 min Read Period 15 To run the kinetic test KINETIC Name KINETIC Pri 405 5 0 Read Time 1 min Read Period 15 sec readwell TOUCH Read Time is total read period of whole test You need to enter it only in minutes Read Period is time interval between two readings You must enter it in seconds The instrument will automatically calculate the number of readings Select pr
50. e positive and negative value of ratio Sample Abs Cutoff Abs In case of Cutoff Index Range It gives the Positive remarks to sample having index value a ratio of Sample abs Cutoff Abs greater than or equal to entered POSITIVE value and It gives Negative remarks to sample having index value a ratio of Sample abs Cutoff Abs less than entered NEGATIVE value The sample having index value in between POSITIVE and range get remarks Equivocal EQ For example If you enter POS gt 1 0 and NEG lt 0 9 Then the sample will get POSITIVE remarks having INDEX Value Sam Abs Cutoff Abs gt 1 000 The sample will get NEGATIVE remarks having INDEX Value Sam Abs Cutoff Abs lt 0 900 The sample will get EQUIVOCAL remarks having INDEX Value Sam Abs Cutoff Abs in the range from 0 900 to 1 000 User Manual readwell TOUCH 19 To save the test after entering all the parameters select option SAVE Name HBSAG POS Cut Off Pri 450 Sec 630 QC QCVal Mes Rem Y 0 100 1 000 Y 0 150 Y N N Factor BL 1 000 1 000 1 000 CUTFAC 0 200 CUTABS NC CF QC1 Y 0 500 Interpretation QC2 N Greyzone 96 Y 10 00 QC3 N Cut off Index N QC4 N Range 0 500 Version No 3 308 Page 35 of 84 Effective Date August 2009 User Manual 10 Example Print out obtained From readwell TOUCH POS Cu
51. er of Blanks 5 Maximum number of Controls 1 Negative Control 05 2 Positive Control 05 3 Cut of control 05 4 Low Positive Control 205 Total number of 20 controls can be run in any combination Pipetting sequence should be as shown below T IT m p LL 1 1 6 10 Readings Check Checking of readings should be done through controls reading that should be 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 3 308 Page 18 of 84 Effective Date August 2009 User Manual readwell TOUCH 7 PRECAUTIONS 9 Do not use any sharp objects on the Touch Screen Always use the STYLUS provided to operate the touch panel Always check for proper grounding before installation Never operate the instrument with ground wire removed 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 Use a clean plate and follow the instructions for blanking and standardizing Do not read any wells containing bubbles or dust particles 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 Monitoring of the printed values or displayed values during operation
52. erials When this label is found pay attention to the manufacturer s recommendations gt gt gt 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 gt This symbol in the user manual indicates that damages to the instrument or erroneous results could occur if the given warnings are not heeded L This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal Version No 3 308 Page 5 of 84 Effective Date August 2009 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 gt This manual contains instructions for operation by qualified personel gt qualified user has to make sure that environmental condition is suitable the installation is correct the use and maintenance are proper according to the general safety rules as well as to the particular precautions described in the manual However he is not entitled to repair the instrument gt qualified technician is entitled to ma
53. etails and come back to previous page NOTE When memory gets full or remains very less memory it will display a message Memory Left samples First Samples Deleted The instrument automatically deletes required number of samples stored very first and saved the new samples at that location Version No 3 308 Page 75 of 84 Effective Date August 2009 User Manual readwell TOUCH 15 UTILITIES In utilities we have seven different functions MAIN MENU UTILITIES Version RBNK 3 308 1 Test Operations 1 Date and Time 2 Diagnosis 2 3 Utilities 3 Printer On Off ON 4 View Plate 4 Enter Clinic Name 5 Serial Communication 5 Shaker 6 Calibrator 7 Communication Settings USB 8 CV Diagnostic OFF 15 1 Date and Time Setting Date DD MM YY Set current Date and Time by Selecting DD MM YY and 01 01 08 Hrs Min Sec Time Hrs Min Sec 12 10 10 15 2 Printer On Off setting UTILITIES Version RBNK 3 308 It is used to turn PRINTER On and OFF If you do not want to use printer you 1 Date and Ti ate and can keep it OFF by selecting this key Program Filter Printer On Off ON Enter Clinic Name Shaker Calibrator 7 Communication Settings USB 8 CV Diagnostic OFF Version No 3 308 Page 76 of 84 Effective Date August 2009 User Manual readwell TOUCH 15 3 Clinic Name Entr
54. factory engineer You can get this message in any mode of operation Before reading absorbance instrument checks the filter reference voltages of all 8 channels If filter voltage of any channel is less than minimum required voltage it will display a message Check Light Path CH x Here x is channel numbers having reference voltage less than minimum required For ex If reference voltage of channel 3 is less the message will be displayed Check Light Path CH 3 It will indicate all channel numbers having less reference voltage like Check Light Path CH136 In such a case there is a possibility of filter gain of that channel has reduced or intensity of lamp of that channel has become poor so contact factory engineer 3 Invalid Assay In Cut Off and Multi standard mode if controls and standard are not proper then this error message will appear If Number of saved tests exceeds the memory limit of 250 tests then LIU delete the unwanted tests and save the test Using data receiving application on computer 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 Computer Do you want to continue such a case select USB communication on computer and select YES N
55. ff Pri 450 Sec 630 NO Factor QC QCVal BL 0 100 NC 1 000 0 150 PC 0 100 0 500 LC 1 000 CC 1 000 CUTFAC 0 200 UTABS 0 563 QC1 2 560 QC2 QC3 QC4 Range 10 00 Version No 3 308 Effective Date August 2009 Page 58 of 84 ESC ACCEPT TEST PRINT Display VALUE LOAD NEXT User Manual readwell TOUCH 6 To check the results of samples select option Display value you will get the details as shown below Name HBSAG POS Cut Off Pri 450 Sec 630 BL 1 Range PERCENTAGE 10 00 Pos 0 330 CUT ABS 0 300 Neg 0 270 SAMP ABS AVG CONC REM PID A1 0 050 0 050 B1 NC Fl 51 0 200 0 200 0 254 HIV 1 G1 52 1 854 1 854 7 245 POS 2 PRINT SAVE PRINT PLATE RESULTS RESULTS MATRIX OPT 7 By selecting ACCEPT TEST option you can save this test with the details of controls absorbance So next time it is possible to you to run the same test without loading controls Means using previous stored values of controls you can find the results of new samples Here you can get all the details in table format as per row and column shows in the screen You can get the print of same format by selecting option PRINT RESULTS To check the results of next samples you choose option NXT and then print it in format shown on screen by option Print Results Or you can get the print in matrix format by selecting option PRINT MATRIX In matrix form you will get the print as per your tray pla
56. imary and secondary filters give a name to test and save it Select RUN to start The following screen will appear 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 KINETIC KINETIC Pri 405 Sec 630 D M D M D M D M D M 1 2 3 4 5 D M D M D M D M D M 7 8 9 10 11 YES Is Plate Loaded NO ESC PRINTMATRIX SEND PLATE LOAD NEXT Version No 3 308 Effective Date August 2009 Name KINETIC Pri 405 D M 1 D M 7 KINETIC Sec 630 D M D M D M D M D M 2 3 4 5 6 D M D M D M D M D M 8 9 10 11 12 YES Is Plate Removed Page 51 of 84 ESC NO PRINTMATRIX SEND PLATE LOAD NEXT User Manual readwell TOUCH It is showing the D M values for each and every well in table format Name ABSORBANCE NORM ABSORBANCE Pri 405 Sec 630 BL N D M D M D M D M D M D M 1 2 3 4 5 6 0 020 0 002 0 010 0 035 0 056 0 001 0 030 D M 7 0 020 0 030 0 056 0 075 0 100 0 068 0 090 ESC PRINTMATRIX SEND PLATE LOAD NEXT 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 1 0 200 0 010 0 020 1 0 300 0 015 0 030 W3 W4 W5 W6 0 100 1 200 0 300 2 600 0 900 these are initial absorbances 0 001 0 005 0 017 0 028 0 001 these are average delta values
57. ingle Blank and single control if absorbance not satisfies QC condition or if located all controls of any single type means all NC controls or all PC controls not satisfy the QC condition the test will become totally invalid It is not possible to make it VALID TEST and you must load the new controls 9 3 Multi Standard Mode Name TSH MULTISTANDARD Pri 450 Sec 630 BL Y 0 000 CAL7 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High gt 25 03 Low lt 10 54 LO CO N High gt 16 61 Low lt 5 45 Interpretation Y Range High gt 15 25 Low lt 9 46 To change values press EDIT Version No 3 308 Page 60 of 84 Effective Date August 2009 User Manual readwell TOUCH 1 You can run this test by selecting RUN option A screen will come Name TSH Pri 450 Sec 630 No of samples 0 DUP N SIMUL 1 2 3 4 5 6 B C1 C2 C3 C4 C5 C6 C7 HI CO 0 COL ROW MULTISTANDARD 7 2 enter total no of HI controls you want to load in plate select CO option and enter numeric value Numeric Value 1 2 7 8 3 If you select no of HI controls TWO Then you have to locate the position of HI controls by selecting column number and row number For column number entry select COL key and enter columns number COL 2 3 Please Enter Col Entry Numeric Value 1 2 7 8 Version No 3 308 Effective Date August 2009 1 Page 61 of 84 User Manual readwell TOUC
58. ings Serial CV Diagnostic OFF 8 CV Diagnostic OFF This setting is very important whenever you want to transfer data from instrument to computer You can transfer data either using USB or by Serial RS232 We provide one application which support to this communication between instrument and computer This application receives data either by USB setting or by Serial setting The options 6 Calibrator is not for user Do not select this utility and change settings in that If you change any numerical values in this utility your instrument calibration will get changed and it will not work satisfactory This calibrator is used for the mechanical alignment of instrument If you changed it the mechanical alignment of instrument will get disturbed So Please do not go to this utility and change any setting The option 8 CV Diagnostic OFF is not for user This is for factory use only Version No 3 308 Page 78 of 84 Effective Date August 2009 User Manual readwell TOUCH 16 SERIAL COMMUNICATION The instrument is equipped with an RS232 serial port 5232 DBS EiA TIA 574 READWELL TOUCH SERIAL COMM Clinic Name or Serial Number MAIN MENU 1 Send Results 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 View Plate 5 Serial communications SERIAL COMM 1 Send Results Results Version No 3 308 Page 79 of 84 Effective Date August 2009 User Manual 17 TECHNICAL DIAGNOSIS read
59. intain and fix the instrument according to the instructions given using the original spare parts Maintain room temperature and Humidity as specified in the manual The instrument has to be used as described in this manual If it is not use the protection provided by the instrument may be impaired Alterations to the instrument are prohibited The user is liable for any improper modification to the instrument and for the deriving consequences Should the instrument need extraordinary maintenance contact MANUFACTURER service or authorized service center Specialized technicians who will be able to repair the instrument using original spare parts will carry out the maintenance gt This IVD equipment complies with the emission and immunity requirements as per 61326 series gt Warning This equipment has been designed and tested to CISPER11 Class In domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference gt advisory that the electromagnetic environment should be evaluated prior to operation of the device gt 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 3 308 Page 6 of 84 Effective Date August 2009 User Manual readwell TOUCH 3 INTRODUCTION 3 1 Description
60. ion 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 User Manual 18 2 Interpretation by Cutoff Index Range readwell TOUCH It is also provided to do the interpretation using Cutoff Index by entering normal range for Positive and Negative Name CPC Pri 450 Sec 630 No Factor BL NC 1 000 PC 1 000 LC 1 000 CC 1 000 CUTFAC 0 200 CUTABS NC PC CF QC1 Y 0 500 QC2 N QC3 N QC4 N RESULT RANGE POSITIVE gt 1 000 NEGATIVE lt 0 900 Numeric Value 1 2 7 8 Name CPC Pri 450 Sec 630 Factor BL NC 1 000 PC 1 000 LC 1 000 CC 1 000 CUTFAC 0 200 CUTABS NC CF QC1 Y 0 500 QC2 N QC3 N QC4 N Version No 3 308 Effective Date August 2009 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 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 Page 34 of 84 Cut off Index is the ratio of Sample Absorbance Cut off Absorbance When you select Cutoff Index Y the Greyzone will become NO means inactive In Cutoff Index provide the range for interpretation th
61. iv 0 150 3 000 By selecting ACCEPT TEST option you can save this test with the details of calibrator absorbance So next time it is possible to you to run the same test without loading calibrators Means using previous stored graph you can find the results of new samples NOTE If you do not want to run the calibrators every time please select ACCEPT TEST option to save graph whenever you run the test with calibrators So that it is possible for you to run the test without calibrators using previously stored graph 9 3 A Invalid assay in Multi standard Mode In Multi standard the absorbance of calibrators should be in increasing or decreasing order from one calibrator to next calibrator If any calibrator s behaves incorrectly you will get a message Invalid Assay at bottom side of screen Name TSH MULTI STANDARD ESC Pri 450 Sec 630 BLY Range High gt 16 61 Low 10 30 NXT HI CO High Low 0 000 LO CO High Low PREV NO SAMP ABS AVG CONC REM PID A1 B 0 050 0 050 SAVE B1 C1 0 070 0 070 0 000 RESULT C1 C2 0 257 0 257 2 500 Invalid Assay LOAD PRINT PLATE ACCEPT PRINT NXT MATRIX OPT TEST RESULTS Version No 3 308 Page 64 of 84 Effective Date August 2009 User Manual readwell TOUCH In such a case EDIT option available in GRAPH screen If you select EDIT the following screen will appear CAL CAL CAL CAL CAL CAL CAL Numeric Value 1 2 6 7 8 CL
62. may help detect an error in the making Check the linearity and calibration of the instrument regularly against some standard reference 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 Recheck the reading of high OD above 24 Place Plate carefully on the tray Ensure that the main power switch is in OFF position before connecting Plug the instrument to the AC mains Confirm proper grounding for trouble free operation Connect the printer only when the instrument is OFF Version No 3 308 Page 19 of 84 Effective Date August 2009 User Manual readwell TOUCH 8 PROGRAMMING MODES 8 1 Absorbance Mode In this mode instrument gives you the only absorbances of all wells of plates which contains controls calibrators and samples Programming a new test uP Select Test Operation 2 Select Add New Test 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 3 Select mode of operation Absorbance in Add new test Select Test Mode 1 gt Absorbance 0 2 gt Single Standard 0 3 gt Cut off 0 4 gt Multi Standard 5 gt Percent Absorbance 6 gt Uptake 7 gt Kinetic 4 Enter
63. n by GREYZONE percentage Select touch zone Greyzone Name HBSAG Pri 450 Sec 630 No Factor BL 1 000 1 000 1 000 1 000 CUTFAC 0 200 CUTABS NC PC CF QC1 Y 0 500 QC2 N N N QC3 Enter Value Value 10 00 Numeric Value 1 2 7 8 Name CPC Pri 450 Sec 630 No Factor BL NC 1 000 PC 1 000 LC 1 000 CC 1 000 CUTFAC 0 200 CUTABS CF QC1 gt Y 0 500 QC2 N QC3 N QC4 N Version No 3 308 Effective Date August 2009 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 POS CutOff ESC QCVal Mes Rem SAVE 0 100 0 150 0 500 Interpretation Greyzone Y 10 00 Cut off Index N Range Page 33 of 84 Enter Greyzone percentage value If you enter Greyzone percentage 10 00 instrument will show you the same as shown in screen It makes the Cutoff Index Range option NO This means when you are using a Greyzone option the Cut off Index Range option will not work In case of Greyzone it gives the Positive remarks to sample absorbance greater than greyzone area of cutoff absorbance and a Negative remarks to sample absorbances less than greyzone area of cutoff absorbance The sample absorbances lying in area get remarks Equivocal EQ NOTE If you do not select any opt
64. nce contract or on specific demand 1 3 Disposal instruction In case of removal or disposal of instrument following instructions need to be followed e Do not dispose in municipal waste follow local regulations for instrument disposal e Plastic parts Electronic PCBs and components can be recycled so return back the instrument to manufacturer 1 4 Contacts Manufacturer European Authorized Representative 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 E Mail mail obelis net ROBONIK INDIA PVT LTD 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 robonikindia com Version No 3 308 Page 4 of 84 Effective Date August 2009 User Manual readwell TOUCH 2 GENERAL SAFETY WARNINGS 2 1 Danger warnings symbols This is a symbol of generic danger It means that serious damage occur to the operator if described precautions are not observed This is a symbol of HIGH ELECTRIC VOLTAGE It is dangerous to touch any part having this label Only qualified operators can access these components after unplugging the instrument from the Supply This symbol indicates that the instrument makes use of chemical reagents and other dangerous Corrosive irritant or harmful CHEMICAL SUBSTANCES which can cause damage to people or mat
65. nt 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 X Display RS232 USB Photo Sensor gt _ Amplifier Version No 3 308 Page 10 of 84 Effective Date August 2009 User Manual readwell TOUCH 5 2 Perspective view Front View 5 3 Rear View 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 optional Version No 3 308 Page 11 of 84 Effective Date August 2009 User Manual readwell TOUCH 5 4 Keypad id TOUCH Ai ELISA Flite Snal yser YES key is used to select any YES option on screen directly NO key is used to select any NO option on screen directly PRINT key is used to get a printout of current screen displayed FEED key is used to forward the paper in thermal printer by one print line Navigation keys are used to select any op
66. orbance 2 Single Standard 3 Cut off 4 Multi Standard 5 Percent Absorbance 6 Uptake 7 Kinetic Version No 3 308 Page 24 of 84 Effective Date August 2009 User Manual readwell TOUCH 3 Entry of test name Select touch Zone Name Name POS CutOff Pri 450 Sec 0 ESC Factor C QCVal Mes Rem SAVE BL 1 000 1 000 1 000 CUTFAC 0 000 CUTABS QC1 QC2 QC3 4 Q N 1 000 N N N N Interpretation Greyzone 96 N Cut off Index Y Range 0 000 Neg 0 000 N N N N After selecting the touching the Name Zone Alphanumerical characters will come in the screen as shown below 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 4 Selection of Primary and secondary filters Select zone Pri on the touch screen Name HBSAG POS CutOff Pri 450 Sec 630 ESC QCVal Mes Rem SAVE CUTFAC 0 000 CUTABS QC1 N Interpretation QC2 N Greyzone QC3 Cut off Index Y Range 0 000 Neg 0 000 Version No 3 308 Page 25 of 84 Effective Date August 2009 User Manual readwell TOUCH After selecting the Pri zone below screen will appear in the display Select the filter required by selecting the filter from Select filter value region Select Filter Val 0 405 450
67. ow lt After selecting the Zone Pri below screen will come in the display gt Select the filters as per details given in the reagent manual by selecting the filter number given in the Select Filter value option Pri 450 Sec 630 Select Filter Val 0 405 450 492 630 000 000 XXX YYY 5 Selection of Blank gt Select Touch Zone BL Name MULTISTANDARD Pri 405 Sec 0 BL N CAL 2 DUP DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low LO CO N High Low Interpretation N Range High Low lt Version No 3 308 Page 39 of 84 Effective Date August 2009 User Manual readwell TOUCH gt Instrument will display the message Blank required Yes No At the bottom of the Screen as shown below select yes if blank is required Name MULTISTANDARD Pri 405 Sec 0 BL N CAL 2 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High gt Low lt LO CO N High gt Low lt Interpretation N Range High gt Low lt Blank Required 6 Entry of Standard Concentration Select touch Zone CAL to enter Number of calibrators and its concentration Name MULTISTANDARD Pri 405 Sec 0 BLN 0 000 CAL 2 DUP N DUP N Graph LINEAR Y vs X ABS vs CONC HI CO N High Low LO CO N High Low Interpretation N Range High gt Low lt gt After selecting CAL below screen will come in the display gt Select Touch Zone No Of
68. per motor Built in Thermal Printer 52 columns Memory Battery back up for 250 tests and more than 2500 results Analysis Mode Absorbance Normal amp Differential Cut off Multi Standard 9o Absorbance Single Standard Uptake Kinetic Connectivity RS232 Serial Port USB 9600 baud 8 data 1 stop no parity bits USB Wattage 75 Watts Operating Conditions Temperature From 18 C to 359 C Relative Humidity Up to 80 Storage Conditions Temperature From 10 C to 409 C Relative Humidity Up to 80 Enclosure Fire Retardant 7 36 36 22 ixbrh Weight Approx Oooo Version No 3 308 Page 8 of 84 Effective Date August 2009 User Manual readwell TOUCH 4 TRANSPORT AND STORAGE 4 1 General Warnings Instrument has to be decontaminated before packing for transportation 4 2 Packing Packaging is needed whenever the instrument is to be transported or shipped by courier or other means To pack the instrument follows the instructions below e Decontaminate the instrument as explained on decontamination chapter of this manual e 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 is attached at the end of this manual e Mark package with address instrument identification and warning labels 4 3 Instrument
69. r HIV test You marked all this samples as a one batch of 80 starting from HIV 1 to HIV 80 If you select PID option for patient ID entry the instrument will ask the following Delete Previous PIDs Yes No If you select NO it will directly load the previously entered PIDs for sample and if you say YES it will delete the previous PIDs Here you have to enter new PIDs After selecting NO select SEQL option to enter different sequential PIDs Follow the steps as follows Version No 3 308 Effective Date August 2009 Page 70 of 84 User Manual readwell TOUCH A Enter Initial Alphabets Maximum 4 characters Enter Alphabets HIV B Enter Initial well Number This is starting well location of that particular batch Enter Initial Sample number Numeric Value 01 1 2 3 7 8 C Enter last well Number This is last well location of that particular batch Enter last sample number Numeric Value 01 1 2 3 7 8 D Enter initial PID Number This is starting number of that particular batch maximum 3 digits Enter initial PID number Numeric Value 01 1 2 3 7 8 Version No 3 308 Page 71 of 84 Effective Date August 2009 User Manual readwell TOUCH The final screen will appear which will display the sequential IDs of patient samples for the well location that you have selected 2 3 4 5 6 7 8 9 1 Suppose have totally 70 nos of samples from three different batch
70. readwell TOUCH 17 2 Lamp Amplitude This option is used to check the Lamp Amplitude of filters used in instrument It shows the gain of each channel filter in table format The range of amplitude is from 600 00 to 2450 00 If this amplitude goes below 600 00 for any channel you will get a message Amp Low for that particular channel and if it goes more than 2490 00 it will show you the over range voltage figure 2500 00 which is also not good because that is saturation level We have perfectly set these gains of filters within a required range When you select this option the lamps will turns ON tray holder plate will come out and instrument will start showing amplitudes gains of all filters one by one Filter 405 CH1 1800 0 1800 0 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 Version No 3 308 Page 81 of 84 Effective Date August 2009 User Manual readwell TOUCH 18 TROUBLE SHOOTING Refer 6 5 Thermal printer You will get this message if paper is not loaded properly or lever is not at correct position Check all 1 Printer disabled possibilities Also check ON LINE and FEED LED glowing or not Disable Printer YES NO and when you switch ON the instrument check paper is moving forward or not If LEDs are not glowing and paper is not moving forward contact
71. s uuuususuassascsassapansssusasesatasqapInaspaqasacusqspanausqsnaqaausus 77 15 5 COMMUNICATION SETTINGS 78 16 SERIAL COMMUNICATION i u u uuu uu u uu uu uu uu 79 17 TEGHINIGAE DIAGNOSIS ices eh i u u uyum a 80 CEERI ENA ORY uuu a gt 80 17 2 LAMP AMPLITUDE Suerte Gur cun We pred Ex Rue 81 12 92 PRINIER SELF TES u uuu gt 81 190 TROUBLE SHOOTING gt 1 45 4 04 4010 diede dito 82 19 DECONTAMINATION 4 41 2 83 19 1 DECONTAMINATION eme rennes rem emis sess essere aerea ena 83 19 2 PURPOSE OF DECONTAMINATION zz 9390 Qua 83 19 3 GENERAL 5 erasa aai 83 194 PROCEDURE 83 20 SAFETY CLEARANCE 84 Version No 3 308 Page 3 of 84 Effective Date August 2009 User Manual readwell TOUCH 1 GENERAL INFORMATION 1 1 Warr
72. tOff Name HCV Pri 450 Sec 630 NO Factor QC QCVal Meas BL 1 Y 0 100 NC 2 0 000 Y 0 150 0 000 PC 2 0 100 Y 0 500 0 000 LC 0 1 000 CC 1 000 CUTFAC 0 100 CUTABS 1 QC1 N Interpretation QC2 N Greyzone s Y 10 0 QC3 Cutoff Index Range HCV 21 07 08 W1 2 W3 WA W5 W6 54 512 520 528 536 544 OPD13 OPD21 OPD29 OPD37 OPD45 OPD53 0 002 0 147 0 091 0 011 0 083 0127 0 362 0 000 1 302 0 803 0 099 0 737 1 122 3 201 POS NEG NEG NEG POS POS B W1 2 W3 WA W5 W6 55 513 521 529 S37 S45 OPD14 OPD22 OPD30 OPD38 OPD46 OPD54 0 062 0 145 0 382 2 535 0 116 1 470 2 573 0 000 1278 3 372 22 39 1 024 1299 2273 POS POS POS EQ POS POS C W1 2 w3 W4 W5 W6 56 514 522 530 538 546 OPD15 OPD23 OPD31 OPD39 OPD47 OPD55 0 040 2 573 0 129 0 159 0 133 0 217 0 077 0 000 22 72 1 136 1405 1177 1917 0 677 POS POS POS POS POS NEG D W1 2 W3 WA W5 W6 57 515 523 531 539 SAT OPD16 OPD24 OPD32 OPD40 OPD48 OPD56 0 080 0 157 2 630 0 141 2 642 0 058 0 155 0 000 1 389 2323 1 246 2333 0 516 1 370 POS POS POS POS NEG POS E W1 2 W3 WA W5 WG 58 516 524 532 540 548 OPD17 OPD25 OPD33 OPD41 OPD49 OPD57 2 562 0 172 0 198 0 061 0 182 0 165 2 656 0 000 1 517 1 751 0 536 1 612 1457 23 46 POS POS NEG POS POS POS F W1 2 w3 WA W5 W6 51 59 517 525 533 541 549 OPD10 OPD18 OPD26 OPD34 OPD42 OPD50 058 2 626 2 612 0 055 0 116 2 649 0 188 0 176 23 19 2307 0 483
73. te it towards the back of the printer Version No 3 308 Page 13 of 84 Effective Date August 2009 User Manual readwell TOUCH Closing the paper cover Close the paper cover and push down on it to lock it into place till you get locking sound 1 Open the paper cover 2 Remove the paper roller from the slot and place the paper roll over it as shown 3 Place back the paper roller with paper into the slot provided and close the paper cover as described before 4 Keep pressing the paper feed switch until the paper feeds straight and smoothly HINT gt When the paper is set correctly and when the closing of the paper cover is proper the FEED LED will not glow gt It keeps on flashing when the data is being printed When the paper is about to finish red lines appear on both sides of the paper Version No 3 308 Page 14 of 84 Effective Date August 2009 User Manual readwell TOUCH 6 6 Start up Instructions 1 Switch on the instrument 2 The instrument initializes all the parameters internally and carries out a power on self test and then displays the following screens and a message will get display Please wait system initializing readwell TOUCH Robonik India Pvt Ltd Plot No A 374 TTC MIDC Mahape Navi Mumbai 400 710 Maharashtra INDIA Tel 022 67829700 Fax 022 67829701 Email sales robonikindia com The instrument will print the model name READWELL TOUC
74. te for all the wells Instrument prints seven different parameter in print matrix for a single well ROW IDENTIFICATION C D WELL NUMBER W1 W2 W3 WELL ID OR SAMPLE NUMBER BL NC PC OR 51 52 S3 PATIENT IDENTIFICATION RAMESH VIKAS etc WELL ABSORBANCE 0 050 0 098 0 085 SAMPLE CONCENTRATION 0 738 0 689 2 578 INTERPRETATION REMARKS POS or NEG or EQ 9 2 A Invalid Assay in Cut Off Mode If any individual control behaves incorrectly and it s absorbance not satisfying the QC check value of that controls you will get a message Invalid Assay and a remarks HI or LO for that control OR if the QC1 QC2 QC3 and QC4 which has a other QC condition of controls like some reagent manual gives condition PC NC 0 2 or NC PC 0 5 If such conditions not satisfy a message will get display Invalid Assay and a remark either or LO for that QC condition Name HBSAG POS Cut Off Pri 450 Sec 630 NOTE The absorbance of controls should not go above 3 500 H it goes more than 3 50 it will C QCVal ACCEPT BL 0 100 TEST NC 1 000 0 150 NO Factor Q Y Y PC 0 100 Y 0 500 PRINT N N C show you the remark for that control such a case the control absorbance 1 000 1 000 CUTFAC 0 200 UTABS 0 563 Display VALUE QC1 2 560 HI QC2 QC3 LOAD Invalid Assay NEXT Version No 3 308 Page 59 of 84 Effective Date August 2009
75. 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 1 2 7 8 14 After entering the details of PCs escape from the screen by selecting ESC Below screen will come on the display Name HBSAG POS CutOff Pri 450 Sec 630 ESC Factor QCVal Mes Rem SAVE 0 100 1 000 0 150 1 000 0 500 1 000 1 000 CUTFAC 0 000 CUTABS QC1 Interpretation QC2 Greyzone 96 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 Cot of controls 15 Entry of Cut off Factor gt Select touch Zone CUT FAC Name HBSAG POS CutOff Pri 450 Sec 630 ESC Mes Rem SAVE CUTFAC 0 000 CUTABS QC1 QC2 QC3 QC4 Interpretation Greyzone N Cut off Index Y Range Pos 0 000 Neg 0 000 N N N N Version No 3 308 Page 29 of 84 Effective Date August 2009 User Manual readwell TOUCH After selecting the CUTFAC below screen will come in the display Value of Cut Factor 0 200 Numeric Value 1 2 7 8 16 Entry of Cut off absorbance equation Select touch Zone CUTABS Name HBSAG POS CutOff Pri 450 Sec 630
76. tion available on current screen ENTER key is used to run any option selected by navigation keys ESC key is used for escaping from any screen HOME key is used to bring plate carrier at home position Home key function is disabled Version No 3 308 Page 12 of 84 Effective Date August 2009 User Manual readwell TOUCH 6 INSTALLATION PROCEDURE AND VERIFICATION CRITERIA 6 1 Unpacking Instructions Check accessories as per packing list Kindly store all packing 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 352 with a relative humidity below 85 Protect it from direct sunshine 6 3 Power Supply Requirements Once the instrument has been placed plug it into a power source by the locally available approved plug in cable Power cord should be CE CSA and UL marked 115 230 Volts 10 50 60 Hz 6 4 Protective Grounding Warning Please make sure that electrical power source is properly grounded 6 5 Printer Readwell touch ELISA Analyser is equipped with a built in 52 columns easy load thermal printer Procedure to load the paper is as follows Opening the Paper Cover LEVER 1 Slide the LEVER towards back of the printer to open lock of the PAPER COVER 2 Lightly push up on the front of the paper cover marked with your thumb and rota
77. 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 Concentrationz Calibrator concentration Calibrator Abs x Sample Abs Name TSH SINGLE STANDARD Pri 450 Sec 630 BL Y 0 000 CAL1 ESC DUP N DUP SAVE HI CO N LO CO N Interpretation N Range Entry of all the parameter is similar to Multi standard mode Please refer Multistandard for entry of parameters Version No 3 308 Page 23 of 84 Effective Date August 2009 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 mean of the negative controls and the mean of the positive control Cut off controls and Low positive is also calculated Programming a New Test 1 Select Add New Test TEST OPERATIONS 1 Select Test By Name 2 Select Test by Mode 3 Select Test by Number 4 List Tests 5 Add New Test 2 Select mode of operation Cut Off in Add new test Select Test Mode 1 Abs
78. well TOUCH Technical Diagnosis is present in Main Menu MAIN MENU 1 Test Operations 2 Diagnosis 3 Utilities 4 View Plate 5 Serial Communication 17 1 Clear Memory TECHNICAL DIAGNOSIS 1 Clear Memory 2 Lamp Amplitude 3 Printer Self test This option is used to clear entire saved test records and entire saved patient results along with saved plates The Test Records are the different kind of programmed test that you have made in different modes of operation and saved in instrument program memory TECHNICAL DIAGNOSIS 1 Clear Memory 2 Lamp Amplitude 3 Printer Selftest Clear Results TECHNICAL DIAGNOSIS 1 Clear Memory 2 Lamp Amplitude 3 Printer Selftest Clear Test Records Version No 3 308 Effective Date August 2009 When you select this option the instrument will first ask Clear Results YES NO If you select YES it will start clearing only saved patient results and saved plates stored in instrument memory and shows message Clearing Memory This option does not clear the programmed test saved in instrument memory After clearing the memory or If you select option NO here it will moves forward to ask next question This time instrument will ask Clear Test Records YES NO If you select YES it will start clearing all programmed test saved in instrument memory and shows message Clearing Memory Page 80 of 84 User Manual
79. wg Wid W11 W12 51 59 S17 325 533 541 549 557 565 573 581 589 OP210 OP218 OP226 OP234 OP242 OP250 OP258 OP266 OP274 OP282 OP280 OP288 1 656 2 541 0 451 0 295 2 618 0 153 0 177 0 882 2 532 0 858 0 845 0 445 6 176 10 30 1 633 1 166 10 20 0 773 0 838 3 222 10 26 3 132 3 083 1 610 POS NEG NEG POS NEG NEG NEG POS NEG NEG NEG Wi w3 wa WS WE WT WB wg W11 52 510 518 526 534 542 550 558 566 574 582 590 OP211 219 OP227 OP235 OP243 251 259 OP267 OP275 OP283 OP299 0 114 0 157 2 520 0 148 0 148 0 118 2 567 1 478 0 475 0 262 0 385 2542 0 664 0 783 9 794 0 761 0 758 0 676 9 388 5 439 1 718 1 075 1 443 9 885 POS NEG MEG NEG POS EQ NEG NEG NEG POS H Wi w3 We WS WB wg 11 W12 53 511 519 527 535 543 551 559 567 575 583 591 OP212 OP220 OP228 OP244 OP252 280 268 276 OP284 OP282 2100 0 867 0 450 0 278 0 344 1 478 0 737 0 106 0 359 0 798 2 544 0 382 0 280 3 165 1 229 1 111 1 303 5 431 2 684 0 642 1 343 2 910 9 895 1 408 1 124 NEG NEG NEG NEG EQ NEG NEG NEG NEG POS NEG NEG Version No 3 308 Page 49 of 84 Effective Date August 2009 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 absorbance s of unknown samples are read and compared to the calibrator absorbance and reported as con
80. y Type your Clinic Name here and select ENTER The character length is M maximum 19 characters READWELL TOUCH 15 4 Plate Shaking Mode Shaker Shake Timein 0 Shake Speed 0 Start Stop Numeric Value 01 1 2 3 7 8 9 Here a total shake time can be put In seconds Regarding Shake Speed there are 10 types of speeds You can choose any speed by entering number from 1 to 10 The shaking speed increases as the number increases After entering shake time and shake speed select Start option When you will select Start the tray will come out and on screen you will get a message Is plate loaded Yes No This time you load the ELISA plate and select option YES 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 shaking gets over the system will bring the tray out and display a message Is plate removed Yes No You remove the tray and press Yes to end the process Version No 3 308 Page 77 of 84 Effective Date August 2009 User Manual readwell TOUCH 15 5 Communication Settings UTILITIES Version RBNK 3 308 UTILITIES Version RBNK 3 308 Date and Time Date and Time Esc Program Filter Program Filter Printer On Off ON Printer On Off ON Enter Clinic Name Enter Clinic Name Shaker Shaker Calibrator Calibrator Communication Settings USB 7 Communication Sett
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