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USER'S MANUAL - Biochemical Systems International

1. Version nore ie e 2005 Workplan L Method Summary Profile Result Calibrator Control wo pP a E Shutdown A Workplan window special for STAT samples programming will appear on the display You can add the required STAT samples compatibly with free positions on sample tray and schedule the tests Forbidden positions will appear as a red row in the table Every STAT ID is preceded by letter E for emergency To request new samples you can do as for routine tests When you are ready click Process Summary window will appear on the screen Almost every button is disabled but you can click Print and Modify button if you need to make some changes to calibrators or controls Then click ok to open Plates window check that all the reagents are correctly allocated and press OK to process the worklist a message will advice you that STAT samples will be analysed as soon as possible Just note that STAT samples are labelled with a yellow triangle with a red exclamation point inside Returning to Main window the light indicator close to STAT label will be green this means that the instrument is waiting to solve pending tests before executing STAT reading Remember that if in SUMMARY wi
2. In the case of using several calibrators the concentration of each sample is calculated using a calibration curve obtained using the selected calculation function and axes A calibration curve is prepared using the programmed concentration values for the calibrators and the absorbance measured for each one A calib Ab x RT The concentration of the samples is then calculated by interpolation of their absorbance in the curve A Ab x RT In the case of the replicates you can choose to use up to three replicates for each sample calibrator or control The blank is always run for as many times as replicates have been programmed for the calibrators Replicates are treated in the calculations in the following way 1 First of all the mean value of the blank is calculated BIOCHEMICAL SYSTEMS INTERNATIONAL Page 71 of 100 FULLY and FULLY SMART User s manual 1 n meand gt A n i 2 The mean absorbance of the blank is then subtracted of each individual absorbance measured for calibrators if used and samples The obtained values are used in the calculation of the sample concentration s or calib MEQN A 3 If you use calibrators the mean absorbance value for each calibration is obtained as follows 1 n meand ai m gt Ca mm meand i i 4 The mean absorbance values of the calibrators are then used in the calculations described in the cases of using factor using a single calibrator using severa
3. Using the same button JVFO you could have informations about every reagent bottle just click it after you selected a reagent from the relative column just click one of the blue rectangles A little window will show you the current level of reagent inside the bottle The button HELP opens a little window which explains the meaning of each colour used in the picture The SEQUENCE button opens a window which lists all the operations performed by the instrument during the tests session the coloured row indicates the current executed operation STATUS MONITOR window informs you also about current temperature of preheater flow cell and reaction wells through the table on top and about execution time through the table on bottom This table gives you the remaining time to conclude the session and the current percentage of execution Reagent and Sample currently in use are showed in green BIOCHEMICAL SYSTEMS INTERNATIONAL Page 63 of 100 FULLY and FULLY SMART User s manual 10 Reprocess test A reprocess test is a test that needs to be re run reprocessed because out of the reagent linearity limit or because of user decision In this case the test will be marked with a RR flag This indicate that the test it has been inserted in the reprocess list and it is going to be re run in the next workplan session The reprocessed test will be automatically post diluted and corrected of the post dilution ratio and back annotate to the origina
4. Reaction well Plow cell Reaction well SAMPLE 1 incubation INC 1 2 incubation INC 2 BIOCHEMICAL SYSTEMS INTERNATIONAL Page 69 of 100 FULLY and FULLY SMART User s manual Fig 11 5 DIFFERENTIAL SUBTRACTIVE MODE For differential subtractive mode several combination are possible see picture below Read interval Stability OD Reaction well Reaction well Flow cell Flow cell R1 Blank R Blank 1 incubation INC 1 2 incubation Empty Read interval Reaction well FI Il A OW ce Reaction well Flow cell Stability SAMPLE BLANK SAMPLE 1 incubation INC 1 2 incubation Empty BIOCHEMICAL SYSTEMS INTERNATIONAL Page 70 of 100 FULLY and FULLY SMART User s manual 11 1 2 Calculations in end point mode In the case of bichromatic readings the absorbance value used in the calculation for blank calibrators and samples is the difference between the absorbance measured at the main wavelength and the absorbance measured at the reference wavelength As Ap 9 A catib Amain wavelength ARer wavelength In the case of using a factor the concentration of each sample is calculated using the following formula C A As X K ae x RT In the case of using a single calibrator the concentration of each sample is calculated using the formula used above for calculations using factor but F is obtained in the following way Co Kfact 2 calib A
5. or ask to your local distributor Serial port configuration procedure First time you start the software the following window appears may appears on the monitor a a KernelFully x Setup gt Instrument off or cable disconnected WORK OFFLINE You have to check if the instrument is off or if the serial connector is disconnected If instrument is on and the cable is rightly connected press setup on this window and select the correct COM port the COM port of your PC connected with the serial cable to the instrument Serial port configuration The first time you install the Saar software the instrument may have the serial port not configured In this case the Setup software is not able to connect to instrument EVEN if the Instrument off or cable disconnected instrument is switched on To setup the serial port just press the setup button on the window beside it will appear BIOCHEMICAL SYSTEMS INTERNATIONAL Page 87 of 100 FULLY and FULLY SMART User s manual another window where the COM port is setup Please be aware that you should only change the COM port number from 1 to 2 if true serial port from 3 to 256 if certified USB to serial adapter is used but you should never change the other parameters that must be as listed below COM PORT from 1 to 4 Baud Rate 38400 Do not change to other values Simulation l disable Check box NOT FLAGGED Except PID Any number Selec
6. 591007 Set of reagent bottles 40 ml 591013 C Set of black reagent bottles 40 ml 592004 Reaction wells segment 50 units 592003 Sample wells 500 units 591009 Waste bottle 591009 Washing bottle 400095 Syringe 590053 Screw for the sample tray 120944 Output adapter flow cuvette 121417 Wash station 080027 Set fuses 5 A 132031 Main wire with ground EEC 132038 Standard cable 170020 C1 Halogen lamp 12V 20W 017007 Filter set 340 nm 017008 Filter set 405 nm 017013 Filter set 492 nm 017009 Filter set 505 nm 017010 Filter set 546 nm 017012 Filter set 578 nm 017011 Filter set 630 nm BIOCHEMICAL SYSTEMS INTERNATIONAL Page 84 of 100 FULLY and FULLY SMART User s manual APPENDIX 1 Software Installation for FULLY and FULLY SMART N B Use this procedure for software for 32 bit or 64 bit system Software is supplied on USB pen drive that contains software and personality files This USB pen drive should never be erased and must be stored in a secure and clean place since it contains essential information for analyser startup Contents of drive will look similar to following i Adobe Reader D Fully SW us i User Manual CompatibiityReadme txt Readme txt W lz Versione rtf Contents F Adobe reader install adobe reader for User s manual F Fully SW contains application soitware to be installed in computer Details later on Ly LIS docs for connecting analyser to LIS system F User Manual This
7. The reaction wells holder is thermostated Transfer arm The transfer arm is fixed to the analyser by means of an axle The arm moves up down and horizontally around the axle during the operations The transfer arm has two needles the right needle aspirates reagent and sample and dispenses both into the reaction well the left needle will later aspirate the liquid of the reaction well to transport it to the flow cuvette The reagent aspirated by the right needle is thermostated while it remains in the tubing inside the arm The needle unit is retractile to avoid damage in case of stumbling GREEN LED The arm will displace to stand by position LEFT NEEDLE RIGHT NEEDLE BIOCHEMICAL SYSTEMS INTERNATIONAL Page 18 of 100 FULLY and FULLY SMART User s manual Reagent bottles and racks The capacity of the reagent bottles is about 45 ml The bottles fit in the supplied reagent racks Each rack admits up to 20 reagent bottles 1 diluent bottle Two racks are supplied with the instrument although only one of them can be placed into the lodging in the instrument The program will automatically distribute the reagents needed for a work plan in the minimum racks and you have to place each reagent in the indicted position of the rack Dispensing The dispensing circuit consists of the right needle the thermostating block the syringe with the needle and with the wash station The syringe has a maximum capacity
8. You will press on New if you want to insert a new patient Modify after you have clicked on the one you are interested in if you want to make a modification Delete if you want to delete one set of data The information you can put in are Surname Name Sex Age Address Location Physician and Notes BIOCHEMICAL SYSTEMS INTERNATIONAL Page 29 of 100 FULLY and FULLY SMART User s manual Quality Control If you click on Quality Control a window will appear which is divided in two parts in the left part you can see the name of the test and the manufacturer in the right one you can see the number of control and the lot number Quality Control Manager Tests Harne Test name die ALP Acid Phosphatase Arriyl Alpha Amylase Alb Blburin HEILT Bilirubin Total Bil D Bilirubin Direct Ca Calcium Cho Chore Chad Lhoresterald 1 Chol Cholesterol Cl Chloride CE ME LE ME Ck Creatine Kinase HERE Creatinine GGT Gamma Glutamyltrar r trt hGELUC Glucose HEL Cholesterol Hdl Controla Name Lot Alkalne Phosphatas lron Lactate Dehydrager Magnesium Alanine Arninotrariste Aspartate Aminatran Delete Report kE Potassium PROT Total Protein Triqhinendes Phos Phosphorus oF If you click one test the controls done since that moment will appear on the right part Therefore you can click on one of them and click on View a new window will appear with the name o
9. 50 60 Hz NOTE Working beyond the tolerance limits will cause the instrument to function incorrectly and the analyser may be damaged BIOCHEMICAL SYSTEMS INTERNATIONAL Page 13 of 100 FULLY and FULLY SMART User s manual Change the fuses according to the following table NOMINAL FUSE VELOCITY Select on the line voltage selector the voltage of your electrical supply Once the voltage selected corresponds to that of the electrical supply proceed as follows Check that the switch is in the OFF position O Connect the power cable first to the analyser then to the electrical supply Put the switch in the ON position 1 2 5 How to start After installing and switch on the instrument the window Main appears and you have to click on Utility button and the instrument initialize itself aka ioe 3 eu urr ad Ug N al 4 ri Ol el IF Er ml ral ma H 5 a BIOCHEMICAL SYSTEMS INTERNATIONAL Page 14 of 100 FULLY and FULLY SMART User s manual On the Utility window click on Prime Diluter button The instrument begins to works in order to prepare the hydraulic circuit After the Prime Diluter operation you have to close the Service window and the Utility window and on the Main window you have to click on Autodiagnosys button BIOCHEMICAL SYSTEMS INTERNATIONAL Page 15 of 100 FULLY and FULLY SMART User s manual Click on Yes when another window will open and the S
10. are the same of a routine workplan see chapter 7 for more details The Shutdown icon It let you turn off the program The Version box displays the current software version installed in the instrument or in the PC BIOCHEMICAL SYSTEMS INTERNATIONAL Page 27 of 100 FULLY and FULLY SMART User s manual 4 2 Report Patient data If you click on Patient Data button on the Main Menu the following window will appear sf Demography TAY BIOCHEMICAL SYSTEMS INTERNATIONAL Page 28 of 100 FULLY and FULLY SMART User s manual In the SampleID column it will appear the list of the patients sample you have inserted in the Work plan If you want to create a link with the information of a patient first you can check if this patient is already present in the database This list is in the bottom part on the left You can write the first letter of the surname in the space Surname in the right bottom part and this will help you in the search If you have found the patient in the list on the left by clicking on it all the relative data will appear automatically on the right part Click on the Link button and all the data will appear in the upper table If the patient is not present in the database or if you want to modify some data about a patient already included press the Database button Manage database Miel Filter for Sumame Apply Sumame Name Sex Age Address Location _ Physician Note did
11. 1 ASH STATION 129007 CLEANING NEEDLE 400094 UBE FOR EXTERNAL TANK 170020 C1 HALOGEN LAMP 12V 20W FOR FULLY cD UBE KIT KODAK BSA 602 VOL 2 5 ml WELL FOR R2 N RITON CONCENTRATED SOLUTION 15 1 100 1 2 LITRE 610058 USER MANUAL RELEASE PROTOCOL ARRANTY UNPAGKING SHEET 110830 ASUS PC BOX FOR FULLY 090018 PC BRACKLET 130084 KENSINGHTON LOCK FOR FULLY BIOCHEMICAL SYSTEMS INTERNATIONAL Page 7 of 100 FULLY and FULLY SMART User s manual 2 2 Main components identification FRONT VIEW FULLY AND FULLY SMART 1 Samples and Reaction tray 2 Wash station 3 Horizontal arm 4 Waste and washing bottles 5 Peristaltic Pump 6 Diluter 7 Reagent Tray 8 ASUS PC not present in Fully Smart 9 PC Bracklet not present in Fully Smart 10 Kensighton Lock not present in Fully Smart BIOCHEMICAL SYSTEMS INTERNATIONAL Page 8 of 100 FULLY and FULLY SMART User s manual REAR VIEW FULLY AND FULLY SMART 1 Power socket 2 Fuses 3 Identification label 4 Waste outlet BIOCHEMICAL SYSTEMS INTERNATIONAL Page 9 of 100 FULLY and FULLY SMART User s manual RIGHT VIEW FULLY AND FULLY SMART 1 RS232 serial port connector LEFT VIEW FULLY AND FULLY SMART De 1 On Off power switch BIOCHEMICA
12. 22S EE In the part Session you can choose if you want to visualise all the sessions performed by the instrument or just today s sessions You have to double click the session you are interested in and choose in the part Report between Patient if you are interested in the patients who have been analysed in that session or Test if you want to see the tests which have been performed on that session At this point you have to click on a test or on a patient in the Test patient part and click View A new window will be open with the information relative to the test or the patient you have chosen Just note that if in the selected session are present some sample out of linearity the Sample out of linearity window will immediately appear See chapter 10 for more details In the case of test the following window will appear BIOCHEMICAL SYSTEMS INTERNATIONAL Page 31 of 100 FULLY and FULLY SMART User s manual Test results EP Batch statistic Refresh Star well z Decimals lo l Export Eon Measuring unit HL Save Ctrl an End well gE Wel ID Resutt Average OD Well Result OD Nate 1 Gianni 110 0 2010 110 0 2010 5 2Coten David 230 0 4215 230 0 4215 mE 1004 1 8424 1004 1 8424 z Pririt Patients list Correlation Modify STO meie EUNE Except Exit The information available are number of well Patient ID OD value Well Result Average OD in the case of replicates the re
13. FULLY SMART User s manual Calibrators values When you click Change values on the Calibrators window the following window will appear Calibrators values Calibrator CalD lasys 1687 Lot ii Bay Test Calibrator et de Alkalne Phosphatase Acid Phosphatase Alpha Amylase Albumin Bilirubin Total Bilirubin Direct Calcium CalDiasys_1687 1687 Chore Lhoresterol 1 Concentration OF Cancel It appears the name and the lot of the calibrator you have chosen It also appears the list of tests that require calibration you have chosen them in the Test Edit window with the correspondent current name and lot of the calibrator you are using If you wish to use the calibrator you have selected in the Calibrators window you have to click the test insert the concentration value and press the OK button Cancel Press this button if you do not want to insert the data about the calibrator anymore Exit Press this button when you have finished edit modify or adding values about calibrators BIOCHEMICAL SYSTEMS INTERNATIONAL Page 47 of 100 FULLY and FULLY SMART User s manual 5 3 How to edit Controls When you click on Control on the Main Menu the following window will appear Controls Test assigned nomal serum abnormal serum H sai Change values Modify Delete Expired D Cancel You will see the list of controls you already have set up The following buttons app
14. G8 od Lid SE Ee EE N EE EE ER 18 3 DESCRIPTION OF THE INSTRUMENT ese esse ke ee ee se ee ee ee Ek ee ERGE ke ke EER GE Re Re ER eek ee Re Re 19 3 1 Technical speeifiesliGms soe ES ERK SA ONE Ee ee GES GE se ee Ne SAW Ge dd Nu Ge GE ee Ge Ge GE Ne N Ge Re AE vu Ge bie 21 4 METHOD OF OPERATION osse ee es on ne ne ee een ee ere ie ere 26 AL EDE ma in n Es ie EE ee eb EG Ge N Ee Ge Ge ee ais E Ee Ge ee 26 aI p AE EE OE EE RT EE ER 29 AS iN EO EE EE EE A ET 37 9 EDITING PROGRAMS sees ee eee ER EE ce EN Ee ee Ge N EA eN RE ENE EG Ee 40 DL HOw to edit test methods ss EE od ENE R OK Se Gee od ENG Ge ie EG RUG Ed GN N Ne de Re N EA ed 40 SA EG te CCGG AUN ALON 8 ies NE ee OE severe We N GE Ke OD N GE GE de er we tetra we eN De 47 5 5 Howto edit COMMU ONS sii ssi ese a De GN Ge N GN GE be eA 49 34 How 10 edi go UR Ee 50 oie AF RE EE EE EE EE N EE 52 7 STAT MO DE ER EE RE OE EE EE EE ennnen 59 8 PAUSE AND ERROR HANDLING oe ees ke e kes Rek k eek ee eke ERGE ke Re ERG ERGE Re ER RR Re Re Re Ee 61 9 STATUS MONITOR ist es ee ie ee ee ee can na Ge see ise Oe ee ae ee ews eee ee 63 10 REPROGESS IE ST soes osse sees soes ew bi ei Oe ees Ee be ee dee ee bee roepe eed de 65 BIOCHEMICAL SYSTEMS INTERNATIONAL Page 2 of 100 FULLY and FULLY SMART User s manual 11 MEASUREMENTS PROCEDURES AND CALCULATION ccccceceecsceecseeeceeees 66 RED RE AR OE EE OE EO EE RE EE N 66 FRIE Procedures in End point TOG Ee ses Ds Ee Ee GR I
15. SMART User s manual absorbance is taken Ao Note that the time required to move the reaction mixture to the cuvette as well as the stabilisation time are included in the incubation one time 11 4 2 Calculations in kinetic mode Catalytic activity is measured by the catalysed rate of conversion reaction rate The rate of conversion is the slope of the absorbance curve versus time and it is calculated with the linear regression method The slope dimension is AA min During the measurement period absorbance values are taken at each second A linear search is performed on each individual set of data to find the linear portion of the data The absorbance values are divided into three segments The slopes of each segment as well as of the whole data are calculated with the linear regression method The slopes obtained for the segments are compared with that obtained for the whole data Those segments giving slopes 20 higher or lower than the slope of the whole data are eliminated from the final calculation The slope is finally calculated with the linear regression of all the values included in the selected segments If the three segments are eliminated the slope of the whole data will be retained for calculations In the case of using a factor the concentration of each sample is calculated using the following formula C 5 x Kfact x RT minj min In the case of using a calibrator the concentration is calculated using the
16. Workplan manager Fi fi Eer et re EE EE Ma Im Alb Ca GOT oe 2 Chol CK CK MB Mew FSi LIN x Run Only Calibration Contrals TT New table Import warklist Copy row Faste taw Y Process In the table you can find information about samples requested ID patient data and requested test You can click one row with the mouse to select and act on it and move inside of it If you select an empty row you can press New button to insert a new sample If you select an existing row you can press Modify to change some setting on the sample or Delete to remove it from the workplan You can also press Copy row to copy an existing row and then Paste row after selecting an empty row in the table to paste it as new sample When you press Process button the program generates the work list relative to the work plan you have created through a particular algorithm to optimise the instrument work This operation is necessary to create the session work list Other buttons present in this window are New table Click this button to create a new table BIOCHEMICAL SYSTEMS INTERNATIONAL Page 51 of 100 FULLY and FULLY SMART User s manual Import Worklist It allows you to import a worklist from an externalPC See appendix 2 for more details Calibrators this buttons open the Calibrators window see section 5 2 for more details Controls this button opens the Controls window see section 5 3 for more details
17. a predilution ratio for this method Performing of predilution is however related to the sample not to the test This means that just setting a predilution ratio for the method is not enough to perform it Predefinition must be activated in workplan module see chapter 6 for more details for each sample which needs to be prediluted sample will be diluted according to the ratio specified for each test performed for this sample If sample is prediluted results are calculated correcting concentration s values according to predilution s ratios of each test performed on it POSTDILUTION The postdilution if programmed for a specific test it is performed whenever a sample is out of the reagent linearity limit In this case the instrument will insert this sample in a reprocess list This list will be automatically post diluted according to the postdilution ratio of this method and represented in the next workplan session as a test to be reprocessed See Reprocess test section below chapter 10 Note 1 The dilution ratio 1s in percentage so for example 1 3 means dilution at 33 Note 2 Whenever a dilution needs to be performed the diluent is taken from the diluent bottle container D position in the reagent rack In the Check Value section you have to set up Minimum and the maximum k factor It applies only to tests using one or several calibrator and where concentration is linearly related to the absorbance measurement Th
18. ePump calibration to compensate the loose of the peristaltic pump rubber an auto calibration of peristaltic pump is recommended as occasional service operation Good value should be inside 0 8 3 5 eService by pressing this button you will access to service menu extraordinary maintenance This operation needs password and is for authorized person only Scheduling It is a reminder of ordinary maintenance and operation Autodiagnosys If you click on this button you have a check of all the elements inside of the instrument as the temperature the filter energy level the filter position etc etc BIOCHEMICAL SYSTEMS INTERNATIONAL Page 37 of 100 FULLY and FULLY SMART User s manual Setup If you click on this button you will open a windows which allows you to edit general settings for the instrument to enter setup menu you need supervisor password In the Printer section you can edit font size line feed and welcome message for the printer In the Others section you find some service flag and some edit boxes to customize your instrument installation data Self initialize on power on allows the instrument to initialize all the stepping motors when software is turned on Enable lamp saving allows the instrument to turn off the lamp when the instrument is not performing any work session to increase its life Shutdown on exit allows the instrument to turn off or to turn off the external PC when software
19. following Directives 98 79 CEE IVD 73 23 CEE EMC 89 336 CEE LV and successive changes Dir 92 31 CEE and 93 68 CEE Arezzo 27 03 2003 Sole Administrator Dr Oliviero Giusti BIOCHEMICAL SYSTEMS INTERNATIONAL Page 96 of 100
20. from the Waste Bottle and to put it on the white connector that is on the left of the bottles BIOCHEMICAL SYSTEMS INTERNATIONAL Page 20 of 100 FULLY and FULLY SMART User s manual It is necessary to put the tube that is in the accessory box on the blue connector that is on the base of the instrument Programming iy Tests unlimited IH Profiles Up to 9 with an unlimited number of tests IH Calibrators H Controls IH Filters Reagents Analysis modes LYEnd point 1 or 2 reagents Differential Fixed time Kinetic iy Multi Standard Kinetic analysis IH Absorbance measurements during the programmed interval H Linearity evaluation F Use of factor or calibrator Calibration types Factor Single calibrator for one test specific or common to several test multiple Calibration curve Calibration curve IHUp to 8 standards i Axes Linear and Logarithmic Calculation functions Spline Linear Regression Square Regression Polygonal Quality Control IH Analytical limits Control Blank Linearity Factor BIOCHEMICAL SYSTEMS INTERNATIONAL Page 21 of 100 FULLY and FULLY SMART User s manual Up to 3 control materials per test LILevey Jennings charts shewart Sample and reagent dispensing One single syringe pipetting up to 1000 ul positive displacement 1 16 ul steps i Sample volume range 2 to 200 ul in 1 16 ul steps Reagent 1 volume range 30 to 1000 ul in 1 16 ul steps LYReagent 2 volume range
21. or calibrator is pipetted together with the first reagent into the reaction wells The reaction mixture is incubated at 37 C for a programmed period of time incubation 1 The second reagent is then pipetted into the well and the reaction mixture is incubated again Next the mixture is moved into the cuvette and the measurement of the absorbance is taken Note that the time required to move the reaction mixture to the cuvette as well as the stabilisation time are subtracted to the incubation time If a 2 incubation time is programmed and the methods requires 2 reagents the 2 reagent is added after the 1 incubation time and incubated for the duration of the programmed 2 incubation time See picture Note also that stability time is used to postpone the readings in EndPoint and Differential methods in order to increase the performance of the instrument and indicates the time in which the reaction is stable expressed in seconds This parameters in FixedTime and Kinetic test is not considered because this kind of methods do not have stability and must be read exactly after Incubation 1 time is elapsed BIOCHEMICAL SYSTEMS INTERNATIONAL Page 66 of 100 FULLY and FULLY SMART User s manual Fig 11 1 END POINT MODE According to programmation in method editor several operation are allowed for End Point test Read interval Stability Stability Read interval 1P ee INC 1 INC 1 OD OD Reaction well Flow cell Re
22. same formula seen above but Kia is obtained in the following way Cis Kfact x In the case of replicates you can choose to use up to three replicates for each sample calibrator or control The blank is always run for as many times as replicates have been programmed for calibrators Replicates are treated in the calculations in the following way 1 First the mean value of the blank is calculated veel 8 TESS BIOCHEMICAL SYSTEMS INTERNATIONAL Page 78 of 100 FULLY and FULLY SMART User s manual 2 The mean value of the blank rate is then subtracted of each individual rate calculated for the samples and for the calibrators if used The obtained values are used in the calculations described in the cases of using factor and of using a single calibrator to obtain the samples AA AA mean min sorcalib min b 3 The mean concentration value of each sample is finally calculated l n Ga it concentrations BIOCHEMICAL SYSTEMS INTERNATIONAL Page 79 of 100 FULLY and FULLY SMART User s manual 12 TROUBLESHOOTING Aspiration needle looking in front of the instrument is the needle on your the left side It has the wider aperture and is cut in a slightly tilted shape Dispensing needle looking in front of the instrument is the needle on your the right side It has the smaller aperture and it has a little tip NEXT PICTURE SHOWS TUBING DIAGRAM BIOCHEMICAL SYSTEMS INTERNATIONAL Page 80 o
23. station ensure that it is clean and that it does not contain any dust particles or other materials that could obtrude the needles 2 3 3 Installing the samples tray To install the sample trays proceeds in the following way Insert the tray into its axle taking care that the two stems in the axle fit into the holes located in the central part of the tray Fix the tray to the axle with the screw provided with the analyser 2 3 4 Installing the reaction wells The reaction wells segments should be placed around the samples tray taking care to insert the stems into the corresponding slots BIOCHEMICAL SYSTEMS INTERNATIONAL Page 12 of 100 FULLY and FULLY SMART User s manual 2 3 5 Installing the reagent racks The reagent rack should be placed into its lodging filled with up to 21 reagent bottles Take care that the rack 1s property fixed 2 4 Connection to power supply It is very important to connect the analyser to a good electrical system It should be as exclusive as possible and it must have absolutely an earth connection for safety If a malfunctioning of the analyser is noticed program crashes sporadic re starts etc check that it is not near machinery containing motors or electromagnets which can generate strong electrical noise In such a case place the analyser far from such equipment Installation category over voltage category II The analyser is able to work at the voltages 110 230 V 15
24. 0 to 1000 ul in 1 16 ul steps HHL iquid detection ohmic Sensor Temperature control 93 thermostated areas Reagent pre warmed in the transfer arm 1 C I Reaction mixture thermostated in the reaction wells to 37 C 2 C F Reaction mixture thermostated in the flow cuvette to 37 C 0 2 C Optical system H Principle interference filter Readings monochromatic or dichromatic Filters wheel with up to 8 filters and automatic filter selection Light source halogen lamp 12 V and 20 W Detector Silicon Photodiode IH Absorbance range 0 200 to 2 500 O D I Spectral range 320 to 690 nm H Wavelength error 2 nm HBandwidth 8 2 nm LYResolution 0 0001 O D HPrecision CV lt 1 2 0 OD Transfer system I Continuous flow system with peristaltic pump IH Capacity of the cuvette flow 18 ul FI Automatic calibration BIOCHEMICAL SYSTEMS INTERNATIONAL Page 22 of 100 FULLY and FULLY SMART User s manual Computer characteristics Only for FULLY In case of Fully Smart these are PC requirements The personal computer that manages analyser software in case of Fully has the technical data showed in its column In case of Fully Smart the column represent recommended hardware to properly run analyser Fully analyser PC Fully Smart PC requirements Processor Intel Processor 2M Cache 1 GHz As Fully or above RAM 2 GBytes RAM At least 2 GB 4 GB or above reco
25. Bioch emical Systems International Srl SEDE LEGALE DMISIO NE STRUMENT Az ONE e mail bi osy bios ye it Wa G Ferrans 220 ia B Buozzi 253 http www biosy it 52100 AREZZO 50013 Campi Bisenzio FI Cap Soc 100 0001 w ITALIA ITALIA C C LAA Arezzo n 135344 Tel 39 0575 984164 Tel 39 055 8963140 Fax 424 0575 984236 Fax 424 055 8997086 Partita I WAOT 36590513 And Automatic analyser USER S MANUAL 610058 26 doc BIOCHEMICAL SYSTEMS INTERNATIONAL FULLY and FULLY SMART User s manual Table of Contents t 2e aie EE EE EE E E E wees aneateenues eeeeuneeteeeess 6 2 UNPACKING AND INSTALLATION iese ies sesse EES SERE SES ENE We EEN RR Re EE ee Ee DE e WE EE T LULIS OE CONE DIS ss n hares iene EE R E a ise setae Ee E N GE Gie 7 2 2 Main components Identificati Misesa Se EN KEER Ee Gee AG dei eb oe RA SS ed dae GN De N AR Na ee Ge ke de 8 2 9 Iastaldstian and TOC AION seed DEK we doe ee ek KA RO ee Ge GE GE ee ra Ge do dd As Ge ke N 12 2 3 1 Installing the sipper system and CUVEE 22 2c cc0rccdacsnscaccerevnnncdnadecnoannsnaddcesnednsdaneaieasesmonnadeenadonsedndeendesndeaveenatenceteses 12 2 2 ostaline the wash SANON eo ee ee EE EE EEE EE ER Ee Ee EO Re EE Rd 13 2 Taste the Sat IE SEEN ae EG E ee oe ee Oe EE Ee ER en Ge ee 13 24 Connection to power supply is as SR De GE Ge N a de N N Ee N N Ee Ek oa ea Ge GE 14 EE EE EE EE EN 15 VELO TII RE EE EE OE EO E 15 DS NOW Ub SURE AA N EE EE EA EE EE EE EE 15 Pd
26. L Page 73 of 100 FULLY and FULLY SMART User s manual 2 The absorbance difference of each sample or calibrator when used replicate is calculated in this way A R2s or calib Aris or calib 3 The mean value of the blank difference of absorbance is then subtracted of each individual absorbance difference calculated for samples and calibrators when used The obtained values are used to calculate the sample concentration Aras mm Arn A R2s or calib ARIs or calib mean AR Arip 4 If you use calibrators the mean absorbance value for each calibrator is obtained as follows 1 n meanA um a 2 Asa Apeans Mean Ans Aris JI i 5 The mean absorbance values of the calibrators are then used in the calculations described in the cases of using factor using a single calibrator using several calibrators to obtain the sample concentrations 6 The mean concentration value of each sample is finally calculated l n C dG 11 2 3 Procedure for subtractive differential mode The subtractive differential test is a modality for which it is zeroed the effect added by adding R2 Theorically every time the R2 is added you have a dilution effect and a photometric offset added by it that should not be consider as part of the reaction Practically in most of the case this effect is near to zero and is effect on the final result is null so the standard differential test it is enough But in some case it may be ne
27. L SYSTEMS INTERNATIONAL Page 10 of 100 FULLY and FULLY SMART User s manual 2 3 Installation and location Please take special care in the installation and in the positioning of this analyser since it is a precision instrument Some of the components mentioned in the following sections are already assembled in the factory and are mentioned here only for repair or maintenance Please follow the instructions below The analyser must be located in a dry and non corrosive place Ambient room temperature should not exceed 34 C and it should not be near a source of electromagnetic radiation e g motors centrifuges nor a source of heat nor directly receiving sunlight It must be located on a flat and spacious surface taking care that no objects obstructs the outlet of air from the fans Leave at least 10 cm from the analyser rear to the nearest wall or object 2 3 1 Installing the sipper system and cuvette The sipper system consists of the flow cuvette the peristaltic pump and the associated tubing To install it proceed in the following way e Insert the peristaltic pump tubing by the shorter end into the cuvette outlet adapter A e Screw the longer tube adapter coming from the transfer arm into the cuvette inlet adapter marked with an arrow B e Place the peristaltic pump tubing by placing the collars inserted in the slots and rotating the tube around the pump rotor Connect the tube on the waste bottle D e Connect the l
28. R Sample will be reprocessed Result has been modified Result has been corrected with correlation algorithm BIOCHEMICAL SYSTEMS INTERNATIONAL Page 89 of 100 FULLY and FULLY SMART User s manual APPENDIX 3 LIS INTERFACE The analyser both Fully and Fully Smart was designed to be used a stand alone or to be interfaced with a Laboratory Information System LIS In this case the analyser can perform the following operations Import a worklist from a remote system by the way of serial port Export results to a remote system The LIS interface can be achieved through serial port For this reason at least number 2 serial ports are needed in order to provide LIS support to analyser since one serial port is needed by the application software to communicate with the analyser the other serial port is needed to connect the analyser to a LIS host See next pages for extra details on connecting the instrument to LIS BIOCHEMICAL SYSTEMS INTERNATIONAL Page 90 of 100 FULLY and FULLY SMART User s manual The picture below is showing how to connect a Fully Smart to a LIS Note that in this case you need a PC that has at least number 2 serial ports Standard USB to serial adapter can also be used T PC with instrument application software RS 232 bie LIS server HOST BIOCHEMICAL SYSTEMS INTERNATIONAL Page 91 of 100 FULLY and FULLY SMART User s manual The picture below show how to connect a Fully
29. Run only calibrator controls 1 user enables this flag instrument will peform onaly calibrators and controls related to test selected Following picture shows the window which appear when user press New or Modify ip Modify sample Available tests i Position 2 Enable predilution l la340d 365 91 23122014 21 Q a340k 363 91 23122014 21 C ACP ZA3000 00 Link patient Clear patient C Alb 4960 32 23122014 1 O ALP 3024 12 11092003 3 Profile 2 Profile 3 Profile O Amyl 4800000 00 O Bil D 13000 00 Prora EL Mu LIBS AR Profile 4 carryover Profile 6 Oca Chal 1000 00 Profile 7 Profile 6 Profile 3 val DO ICK 4127 00 EICK MB 6666 00 Accept loci AS O D340 Cancel IOIDGLUC a User can select test to perform or to remove clicking the box near the name of the test It is also possible to ask a complete profile clicking the related button flags on the list will automatically appear near test which are present in the profile To allow or disable Predilution for the sample click check box Enable predilution To link a patient to the selected sample press Link patient following window will appear BIOCHEMICAL SYSTEMS INTERNATIONAL Page 52 of 100 FULLY and FULLY SMART User s manual user can select a patient from the list and then click Link to assign the patient data to the sample Clear button will clear the assignment Database butto
30. action well Flow cell TWO REAGENTS 1 incubation INC 1 ONE REAGENT 1 incubation INC 1 2 incubation Empty 2 incubation don t care Read interval se Ka Stability E r 1 gt OD INC 1 Flow TWO REAGENTS 1 incubation INC 1 2 incubation INC2 Sample Reagent 1 Reagent 2 First incubation time Second incubation time Aspiration time Stability time Absorbance measurement Absorbance measurement at n second BIOCHEMICAL SYSTEMS INTERNATIONAL Page 67 of 100 FULLY and FULLY SMART User s manual Fig 11 2 KINETIC MODE Reaction curve S R R AA EE 7FY EE INC 1 ODn OD1 Reaction well Flow cell Reading are taken each second for all the duration of the reaction time kinetic interval 2 incubation time During the 1 incubation time no read is taken Fig 113 FIXED TIME MODE Reaction curve S R R 1 ER St OOOO INC 1 OD2 OD1 Reaction well Flow cell Reaction is followed for all the duration of 2 incubation time each second sampling For result calculation anyway only initial and ending value are used BIOCHEMICAL SYSTEMS INTERNATIONAL Page 68 of 100 FULLY and FULLY SMART User s manual Fig 11 4 DIFFERENTIAL MODE For differential mode several combination are possible see picture below Read interval Stability Reaction well Reaction well BLANK SAMPLE 1 incubation INC 1 2 incubation Empty
31. again will include again this result You have also the possibility to calculate statistic parameter choosing start and end well in the part Batch statistic Correlation if you press correlation button the following window will appear BIOCHEMICAL SYSTEMS INTERNATIONAL Page 33 of 100 FULLY and FULLY SMART User s manual Cormelation conection a ID PResut SetResut_ New Result 1Gi 110 112 112 ee 2Co 230 231 231 E7 1004 399 Slope 0 991667 Dave Ee point Intercept 2 91667 So This window allows you to post process results with a linear correlation algorithm M Use Intercept 4 Restore Set point i These feature could be very useful if in the selected batch you processed samples of known value together with unknown value samples In this case it could happen that results obtained for control sera are not perfectly the expected one due to a not exact calculation of k factor given in the sheet of your kit With this window you can recalculate all the results applying a linear correlation algorithm to the entire batch You can select in the table the samples of know value and set the correct results with more than one set point the instrument will calculate corrected result with linear correlation algorithm and show the related graph and values of slope and intercept of the linear curve You can also choose to use or not intercept to determine new results This feature allows you to adjust k factor of the kit i
32. ample volume plus set volume of R2 EP MSD with 2 Takes a volume of R1 equal to reagent reagent Two of reagent volume and sample volume _ volume plus a volume of distilled water steps preparation set Add R2 volume after first equal to sample volume Add R2 volume incubation time after first incubation time DIFFERENTIAL Takes a volume of R1 equal to the sum Takes volume of R1 plus volume of Single or two of reagent one and reagent two anda __ distilled water equal to volume of R2 plus steps preparation volume of sample equal to set sample volume of sample volume for the test Preparation of sample remains the same with or without Water Blank see section 11 for more details In the Calibration section you can choose among the following kfactor In this field case you will write the k factor value you want to be considered for the measurements Multiple Choose this option if you want to use the same calibrator for more than one test Specific Choose this option if you want to use a calibrator specific for one reaction In the edit box below you can choose how often repeat the calibration N standard In this field you will write the number of standards you want to use Replicate In this field you will write the number of standard s replicates you want to do Offset In this window you can write a number you want to be added to all the results Concentrations In this field you will write the concentration s of th
33. are lo yu 0 j0 IN j0 ID jo 10 yo 0 jo ID 10 In jo ID OF k You can choose the position of the reagents to put in the reagent rack To do this you click on one reagent and you move it into the desired position If you want to put all the reagents on the right column following the same order press All Press Clear to remove all the reagents from the rack and restart the allocation from the beginning Press Load to restart from last reagent rack layout Cancel you go out without saving Print you can print the image OK When you are ready press OK and the software will process the worklist When both the grey strips labeled with 0 100 become blue a message will advice that the instrument is ready to start the session You can now press START button on Main window If you press on Zoom button you can see the sample image enlarged and a description of the samples type minimum volume and Id sample If you press Help button a little window will appear to explain the meaning of every color present in the sample tray image BIOCHEMICAL SYSTEMS INTERNATIONAL Page 57 of 100 FULLY and FULLY SMART User s manual 7 STAT Mode This section explains how FULLY and FULLY SMART can perform emergency tests during the execution of routine session At any time while the instrument is working press STAT button in Main window LL r Session Repot __ Ed Utility
34. assumes no responsibility for any errors which may appear in this manual Our policy is to improve products as new techniques and components are available Biochemical Systems International therefore reserves the right to change specifications at any time We would appreciate any comments on this manual you can send yours to the above mentioned address We thank you since now for your collaboration This manual is valid for FULLY and FULLY SMART analyser The software which is the same for FULLY and FULLY SMART should run on a Windows c based PC which should be connected to the instrument via serial RS232 port The connection between PC and external printer can be achieved through a USB port Regarding the installation of the software on the PC please refer to APPENDIX 1 The contents of this manual are property of Biochemical Systems International Srl and are not to be copied reproduced or transferred to another person or persons without our prior written permission Copyright Biochemical Systems International Srl All rights reserved Printed in Italy BIOCHEMICAL SYSTEMS INTERNATIONAL Page 5 of 100 FULLY and FULLY SMART User s manual 1 Foreword First we would like to thank you for the purchase of our analyser Our analyser is very easy to use and we are sure that it will be a valid instrument for your laboratory This instrument has been designed to perform spectroscopic measurements at predetermined wavelengths of analyte con
35. at require calibration you have chosen them in the Test Edit window with the correspondent current name and lot of the control you are using If you want to use the control you have clicked in the Controls window you have to click the test insert the concentration limit values lower and upper limit and press the Apply button If you have three levels of Control Low Medium and High before inserting the concentration limit values select one of these three Cancel Press this button if you do not want to insert the data about the control anymore OK Press this button when you have finished edit modify or adding values about controls 5 4 How to edit Profiles When you click on Profile on the Main Menu the following window will appear BIOCHEMICAL SYSTEMS INTERNATIONAL Page 49 of 100 FULLY and FULLY SMART User s manual Profile 1 Print te First you have to select one of the nine Profiles You can change the name of the profile going im the apposite space You can add one or more tests taking those out of the available tests clicking on it them and then click on Add You can also remove or move up or down one or more tests clicking on it them and click on Remove or Move up or Move down BIOCHEMICAL SYSTEMS INTERNATIONAL Page 50 of 100 FULLY and FULLY SMART User s manual 6 WORKPLAN When you click the Work plan button in the Session part of the Main Menu window the following window will appear fii
36. calibration Calibration EE ID Name Method Manufacturer ExpiringDate LastUpdate sl ALF Alkaline Phosphatase Kinetic EIEE lgl ACP Acid Phosphatase Kinetic 2SIOF 2003 09 22 33 Arn alpha Amylase Kinetic 1092003 11 59 09 Alb Albumin EndPoint inul inul 19 12 2014 05 45 04 HBILT Bilirubin Total Differential 2912 2005 09 57 55 Bil D Bilirubin Direct Differential 12 09 2003 10 31 19 Ca Calcium EndFoint 25 11 2003 21 17 57 Chol Cholesteral EndPaint inul inul 19 12 2014 05 09 22 Cl Chloride EndPoint 2507 2003 09 22 57 CE ME CE ME Kinetic 27108 2003 11 50 37 CK Creatine Kinase Kinetic 16 09 2003 16 31 25 hCREA Creatinine FixedTime 29 12 2005 09 57 59 GT Gamma Glukamyltranserase Kinetic 2708 2003 11 16 52 HSLUc Glucose EndPoint null 19 12 2014 05 09 31 HOL Cholesteral Hdl EndPaint 31 01 2003 09 57 49 Fe Tron EndPaint OF fOS 2003 09 00 13 ALDH Lactate Dehydrogenase Kinetic 29 12 2005 09 58 07 Mg Magnesium EndPaint 31 01 2003 09 58 12 SPT Alanine ArminotransFerase Kinetic 2411 2003 04 34 25 GOT Aspartate Aminotransferase Kinetic OF MOfPO03 17 55 04 Phos Phosphorus EndPaint 109003 12 04 58 K Potassium EndPoint 25 07 2003 09 22 49 PROT Total Protein EndPaint 31 01 2003 09 56 30 TRIG Triglycerides EndPaint 17I0a 2003 14 08 09 URIZ Uric Acid EndPaint 31 01 2003 09 58 42 at You can find some already edited tests some of them may be pre edited by the manufacturer and the following buttons Key supervisor It let you insert the passw
37. centration and enzyme activity using various reagents You can perform any combination of tests up to 54 samples per work plan The analyser automatically performs all reagent and sample pipetting incubations photometric measurements and calculations Programming and operating the analyser is simple and made easy by Windows TM Its sophisticated software allows you to program and permanently store in memory an almost unlimited number of tests up to 9 test profiles calibrators and controls You can create routine work plan by assigning patients data and tests and or profiles to sample You can prepare a second work plan or use the computer internal or external while the analyser is performing the first work plan Once the results have been obtained you can request reports organised per patient or per test or examine the quality control data The analyser can perform end point one or two reagents monochromatic or dichromatic differential mode fixed time and kinetic mode measurements Calibration can be made using a factor or using calibrators Up to nine standards calibrators can be programmed If several calibrators are used you can select your favourite calculation function polygonal spline regression line regression parabola scale linear or logarithmic and study the calibration curve Samples can be distributed in up to three racks containing 24 18 12 position each Up to 20 reagents plus container for dilution can be distribute
38. d in one row change of a single reagent container or of the entire plate in the analyser should be manually performed The program automatically distributes in racks the reagents required for a work plan and indicates the minimum required volume of each one There is also the possibility to program the reagents in fixed rack positions The program includes a complete range of analytical controls allowing you to obtain flagging of abnormal results linearity limit blank absorption limit kinetic blank limit factor obtained from calibration limits and reference interval Up to three different control materials per test can be included in the work plan Quality control results can be permanently stored and can be examined as a list or in the Levey Jennings chart format or in Shewart Chart BIOCHEMICAL SYSTEMS INTERNATIONAL Page 6 of 100 FULLY and FULLY SMART User s manual 2 Unpacking and installation Please read this chapter carefully before installing the instrument First check that the packing is in perfect condition and that the seals are intact Do not throw the packing material away because you could need it in case of re shipment 2 1 List of contents This is the set of items that you can find on unpacking the instrument 1 the Analyser 2 A box containing accessories 3 A sheet with instructions for unpacking Contents of box 300206 S _ SAMPLE TRAY 592004 REACTION WELLS SEGMENT 132031 SCHUKO POWER CABLE 121417
39. dit buttons will open the Controls window which can be open also from Main menu see section 5 3 for more details BIOCHEMICAL SYSTEMS INTERNATIONAL Page 45 of 100 FULLY and FULLY SMART User s manual 5 2 How to edit Calibrators When you click on Calibrator on the Main Menu the following window will appear calibrators Multicalibrators Test assigned Hame Lat Test cal normal 1685 4 a l Modit o Mody e Change values Hew Delete EET Lot Cancel OF You will see the list of calibrators you have put in The following buttons appear in the window New It let you insert a new calibrator After you have pressed this you have to insert the name and the lot of the new calibrator Modify It let you modify the name and or the lot of an already edited calibrator Press the name of the calibrator you want to modify and then press the button Change values When you press this button the Calibrator values window will appear Press the name of the calibrator you want to add values in and then press the button Delete It let you delete an edited calibrator Cancel Press this button if you do not want to insert the data about the calibrator anymore OK Press this button when you have finished to insert the data about the calibrator Exit Press this button when you have finished edit modify or adding values about calibrators BIOCHEMICAL SYSTEMS INTERNATIONAL Page 46 of 100 FULLY and
40. e printer Utility It let you perform the services about the instrument like maintenance etc It has to be used only by an expert technician Scheduling It let you schedule the maintenance of the instrument which part and how often Once you have set this data a window will appear you as you turn on the instrument to remind you the maintenance you have to perform In this part you can also write all the maintenance operations you or a technician has performed with comments Autodiagnosys It let you perform an automatic diagnosis of the entire system both electronic and mechanical components Regarding this part please see also Chapter 4 3 Utility The Status icon It let you see which session the instrument 1s performing and gives you information about the wells and about the current temperature Above you can find two indicators the first one informs about STAT status off if no STAT sample have been requested green if STAT sample have been requested but the instrument is still performing routine tests red if the instrument is performing STAT tests the second one inform about PAUSE BIOCHEMICAL SYSTEMS INTERNATIONAL Page 26 of 100 FULLY and FULLY SMART User s manual mode off if no pause has been requested green if a pause has been requested but the instrument is still working red if the instrument is in pause The STAT icon It let you analyse urgent sample during a routine session The steps to be followed
41. e Ne Eg AN oe n ee oe Ge ie n EG 66 1 1 1 1 Procedures in tests using one tape EES Ee ee RE ke ee ee ee Ge ee ee Re ee ee 67 j1 1 1 2 Procedures in tests using TWO reagents es Ee Gee ee ee RR ee es RR ER 67 11 12 Calculations 1 end pont Hide ee ee EE RE ee ee NG Ge Ee Ee ER ee Ee 73 i DT n issie ee GR Ge eN ee ee ee N ee De ie N Ge ke Ge EG N ee EE We be ee 74 11 2 1 Procedure im differential model sea EE ee Ee ER ee EG Ee Ee OG EE RE INEEN Eaa 74 L122 Calculations tin differential MOG icc sccc ccccsvececancsvchsuiensesevecandeeeedcsacsnsanncdeadstaedoavneoncseededtandiasduadoeadededucesesdeancoaedaedes 75 11 2 3 Procedure for subtractive differential moOde cccccscosscosecosccssccoscosscosscescosscosscovscesccscavscescccsecessecscaescecs cess 76 11 2 4 Calculations in subtractive differential mode ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 77 Ed TER DU SE EE ee OR OE N N OE OE EE ER N EE GEE OE OR 77 11 3 1 Procedure in fixed time mode sae se Rees ee ee Eed ee Ke GR Ee GR KG Ee GE RE Ge Se Ge Ge Ge Re ee We se ee 77 11 3 2 Calculations in fixed time mode ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 78 FA Kinnie GE EG RE EG Ge A 79 11 4 1 Procedure in kinetic Ode iS EE ee ee ee id EE EG EE EE ee EE 79 114 2 Calculations 1m kinetic MOE ss Se oe ee ee ee Ge ED EE ee Se Ge 80 12 TROUBLESHOOTING ii ai ee es Oe OE ND Ee EE sox 82 13 ACCESSORIES AND REPLACEMENT COMPONENTS ee s
42. e blank reaction 11 1 End Point In this method the absorbance of the reaction mixture is measured at one unique time You can use one or two reagents and the absorbance can be measured at one wavelength monochromatic or at two You can base the calibration on the use of calibrators one or more or on a programmed factor 11 1 1 Procedures in end point mode The procedure is different for test using one or two reagents Figure 11 1 In the case two reagents are used a second incubation period after pipetting the second reagent and before taking absorbance measurement is required In dichromatic readings two measurements are made of each reaction mixture at each of the programmed wavelengths A blank is always prepared for each test by using distilled water instead of the sample and reading against a baseline of water BIOCHEMICAL SYSTEMS INTERNATIONAL Page 65 of 100 FULLY and FULLY SMART User s manual 11 1 1 1 Procedures in tests using one reagent The sample or calibrator is pipetted together with the reagent into the reaction wells The reaction mixture is incubated during the programmed period of time The mixture is then moved to the cuvette and after the stabilisation time has elapsed the absorbance is measured Note that the time required to move the reaction mixture to the cuvette as well as the stabilisation time are included in the incubation time 11 1 1 2 Procedures in tests using two reagents The sample
43. e instrument calculates a factor after performing a test to transform the measured signal into concentration values If you select it an information message will be issued when the factor value is out of the limits Type the maximum and the minimum values for this factor 0 to 99999 If you do not select it the program does not perform any check Washing In this field you can write the number of required washings BIOCHEMICAL SYSTEMS INTERNATIONAL Page 44 of 100 FULLY and FULLY SMART User s manual Extrawashing this check box allows an extrawashing for needles between dispensing in reaction well and next preparing cycle Purge flow Cell allows to perform a quick washing for flow cell between each reading aspirating distilled water from bottle in position D Button Cancel Press it if you want to exit without saving the set up data Button Restore Press it if you want to restore all the initial data Button OK Press it when you have finished inserting all the parameters required for the test Control Serum window Control serum Low control Hare pm R t EE Jo First Last Edit Normal control Mame Repeat fo JO First D Las Edi Repeat fo JO First Las Edi every This window sums allows you to edit some parameters about control serum reading for the selected test frequency of reading read control serum before the first sample read the control serum after the last sample Clicking on e
44. e prepared following the manufacturer instructions Check if you have used the recommended wash solution Kinetics tests underestimated It could be that the cell or the reagent is contaminated and bacteria may inhibit the reaction Clean the cell or change the reagent container Check if you have used the correct factor Check the temperature and the volume you have set Check which water reagents control serum and wash solution you have used Check the filter Check if the reagent is expired not fresh or not correctly stored Home error PID 3 Syringe is blocked Disassemble the syringe and wash it with current hot water during washing internally Aspirate some alcohol with the syringe in order to soft the Teflon plunger If you have some problems concerning moving parts of the instrument arm diluter sample rotor we suggest to add some grease on the belts BIOCHEMICAL SYSTEMS INTERNATIONAL Page 83 of 100 FULLY and FULLY SMART User s manual 13 ACCESSORIES AND REPLACEMENT COMPONENTS Please contact Biochemical Systems International Srl or your local distributor if any component of the analyser deteriorates or if you need consumable material such as sample and reaction wells or reagent bottles Use always original material and order any part with its code Here you can find the list of all the components or accessories you could need CODE DESCRIPTION 610058 User s Manual 300206 S Sample tray 300207 S Reagent rack
45. e standard s you are going to use for the calibration Decr Incr Select Decr if the absorbance decreases with concentration end point multistandard differential or decreases with time fixed time kinetic Select Incr if the absorbance increases with concentration end point multistandard differential or increases with time fixed time kinetic Calculation Function You can choose the function you prefer to fit the results i e spline polygonal etc Axe X and Axe y Choose the scale to be used for the calculations and for the graphics between linear and logarithmic Button Cancel If you want to go out of the window without saving data you have put in BIOCHEMICAL SYSTEMS INTERNATIONAL Page 42 of 100 FULLY and FULLY SMART User s manual Button Option If you press this button the Parameters Options window will appear Button Control Serum Press this button if you want to Quality Control using Control Serum The Control Serum window will appear Button Print To print out setting data Button OK When you have finished setting all the parameters required for the test Parameters Options window When you press Option in the Edit test window the following window will appear T Predilution Predilution A atio Mo dil Postdilution Postdilutian A atio Linearity limit 7 00 Mo dil Absorbance limit Check Value Min KF actor Mas KF actor Extrawashing G Was
46. ear in the window New It let you insert a new control After you have pressed this you have to insert the name and the lot of the new control Modify It let you modify the name and or the lot of an already edited control Press the name of the control you want to modify and then press this button Change values When you press this button the Control values window will appear Press the name of the control you want to add values in and then press this button Delete It let you delete an edited control Cancel Press this button if you do not want to insert the data about the control anymore Apply Press this button when you have finished inserting the data about the control OK Press this button when you have finished edit modify or adding values about controls BIOCHEMICAL SYSTEMS INTERNATIONAL Page 48 of 100 FULLY and FULLY SMART User s manual Controls values When you click Change values on the Controls window the following window will appear Controls values Control Aeee Lot li 327 Test Como St er Upper Sf Level Alkaline Phosphatase Acid Phosphatase Alpha Amylase Albumin Bilirubin Total Bilirubin Direct Calcium Chores Choresterol Cholesterol Values Apply Ctl Low 1 Chl Medium 2 Ctrl High 2 Delete Cancel Concentration limit Lower x The name and the lot of the control you have chosen appear on it It appears also the list of tests th
47. eded to use the differential subtractive method to overcome this problem For this test you need to have 2 reagent bottls one containing the reagent 1 called R1 the second containing a mixing of reagent and reagent 2 according to the kit called R2 Number 2 blank wells are prepared before start sampling Reagent 1 blank BLK1 and Reagent 2 blank BLK 2 BLANK 1 VoIR1 R1 VolSmp H20 BLANK2 VoIR2 R2 VolSmp H20 BIOCHEMICAL SYSTEMS INTERNATIONAL Page 74 of 100 FULLY and FULLY SMART User s manual That is the designed quantity for RI is taken by R1 bottle plus the designed quantity of sample volume is taken by the dilution bottle In this case the dilution bottle should contain distilled water or fisiologic solution The sample control and calibrators are prepared in this way SAMPLE BLK VoIR1 R1 VolSmp Smp SAMPLE VolR2 R2 VolSmp Smp The reading is taken after the 1 incubation time is elapsed 11 2 4 Calculations in subtractive differential mode Either if you are working against factor os standard in this case the factor 1s calculated using the input standard concentration calculation are as follows A O D value of BLANKI VoIR1 R1 VolSmp H20 B O D value of BLANK2 VolR2 R2 VolSmp H20 C O D value of SAMPLE BLK VoIR1 R1 VolSmp Smp D O D value of SAMPLE VoIR2 R2 VolSmp Smp D B C A x Kaa x RT In the case of using a single calibrator the concentratio
48. eft tube coming from the diluter to the washing bottle E e Put the two connectors of the Waste and Wash Bottle on the vertical wall in particular the red connector waste on the right and the black connector wash on the left e Place the cuvette into its lodging with the face marked with an arrow towards the analyser front side Fix the screw holding the cuvette eF ill the Wash bottle with less then 0 51 of water Follow these instructions to add tensioactive if you use Triton solution given in the starter kit it should be diluted with ratio 1 100 as specified in the bottle s label if you use commercial tensioactive you should dilute it with ratio 1 1000 elf the needle are protected with silicone tubes on the top take off the protections eFix the two tanks tygon tubes to the black holders which are above the red and black connectors to prevent that tubes fall over the sample tray NOTE When you fit the tubing into the peristaltic pump do not twist it to avoid a bad positioning and do not stretch it in excess for it can cause an irreversible distortion After the daily use do not remove the tubing from the pump The analyser keeps it soaked with water to preserve it from drying BIOCHEMICAL SYSTEMS INTERNATIONAL Page 11 of 100 FULLY and FULLY SMART User s manual 2 3 2 Installing the wash station The wash station should simply be placed into its lodging located in the upper part of the case Before using the
49. elf test will run After finishing you can verify on the window if there are no warnings and no errors If there are some problems please contact your distributor If there are not problems your instrument is ready to work BIOCHEMICAL SYSTEMS INTERNATIONAL Page 16 of 100 FULLY and FULLY SMART User s manual 2 6 Re shipment If the analyser has to be re shipped for any reason or has to be moved involving the use of a transport vehicle it is important to use the original packing to ensure that the instrument does not suffer any damage Figure shows how the analyser and its accessories must be packed BIOCHEMICAL SYSTEMS INTERNATIONAL Page 17 of 100 FULLY and FULLY SMART User s manual 3 Description of the instrument The instrument is composed by the following parts Samples tray The samples tray has 54 numbered holes each one able to lodge a sample well The sample well can contain a sample calibrator or control Reaction wells The reaction wells surround the samples tray There are 12 rows of 12 wells each resulting in 144 available reaction wells The use of new reaction wells is recommended However if you reuse reaction plates you have to be sure that they are properly washed rinsed and dried The reaction wells have been designed to make the mixture of the sample with the reagent during the pipetting as easy as possible and have a maximum useful capacity of 1 ml
50. erence of absorbance is then subtracted of each individual absorbance difference calculated for samples and calibrators when used The obtained values are used to calculate the sample concentration Aras mm Any Ars or calib Aris or calib mean Atop Arip 4 If you use calibrators the mean absorbance value for each calibrator is obtained as follows 1 n meanA im m 2 Ca Ap cap mean Ars Ar I i l 5 The mean absorbance values of the calibrators are then used in the calculations described in the cases of using factor using a single calibrator using several calibrators to obtain the samples concentrations 6 The mean concentration value of each sample 1s finally calculated l n Ee 11 4 Kinetic The kinetic mode is used to measure catalytic activity concentration The absorbance of the reaction mixture is measured 3 times during the programmed total period of incubation A single reagent must be used in this procedure You can base calibration on the use of calibrators one or more or on programmed factor 11 4 1 Procedure in kinetic mode The sample or calibrator is pipetted together with the reagent into a reaction well The reaction mixture is incubated during the programmed period of time incubation time 1 The mixture is then transported to the cuvette and after the stabilisation time has elapsed a first measurement of the BIOCHEMICAL SYSTEMS INTERNATIONAL Page 77 of 100 FULLY and FULLY
51. ert USB pen drive and copy the folder Layout in C instrument overwriting the existing one Layout folder contents Is LayoutEstDil ini LayoutOther ini LayoutReact yell ini GE LayoukRieagent ini LayoutSample ini Layout olume ini LayoutWasher ini You can direclty select the whole LAYOUT folder and drag and drop on c instrument folder overwriting existing folder and files d Layout gt backup di instrument di Language DRAGANDDROP J Layout di Log di Profile di Service M Secon By doing this operation you will overwrite the default installed setting with files belonging to your analyser Each analyser has its own USB pen that contains software and personality files Now analyser is ready to work See serial port configuration procedure later on BIOCHEMICAL SYSTEMS INTERNATIONAL Page 86 of 100 FULLY and FULLY SMART User s manual software upgrade procedure Upgrade For a sofftware upgrade it is necessary to double click on the file Then run file maybe named sligltly different according to version numbering Say Fully upgrade 200 exe Setup will prompt for destination folder generally is c instrument Select it if different and click next Setup will make software upgrade automatically No other step are necessary since all personality files are manteined NOTE You may search for software upgrade on www biosys it following the link Software
52. esent to start the search If you remember only partially the surname of the patient you can insert the part you remember followed by a the search engine will display all the result compatible with inserted letters For example if you insert Frank in the surname field the search engine will display results related to Mr Franklin and Mr Frankenheimer 4 3 Utility BIOCHEMICAL SYSTEMS INTERNATIONAL Page 36 of 100 FULLY and FULLY SMART User s manual Setup If you click on Setup button on the Main Menu you can set up the printer Utility When you click on this button you open this window Utility Ea Initialize nitialize the arm and the rotor will be moved on the start right position ePrime diluter will perform 1 cycle of diluter priming Useful to fill up all the hydraulics for checking hydraulics to remove air bubbles from syringe e Wash cuvette will perform an aspiration with peristaltic pump through cuvette Can be used if the peristaltic pump needle is dirty or blocked and the instrument do not have good aspiration from peristaltic pump Sodium hypoclorite 10 solution in water can be a good washing solution e Volume calibration only perform this kind of calibration if you are experiencing too high dead volume in reagents bottle or if a washing cycle is not efficient because of the too high residual volume left in the washing well ePhotometer check manual functioning of photometer
53. etic Compatibility EMC Part 6 3 Generic norms Immunity for residential commercial light industry environment CEI EN 61000 3 2 2002 04 Emissions Harmonic CEI EN 61000 3 3 1997 12 Emissions Tension fluctuations Flicker CEI EN 61000 4 2 1996 09 Electrostatic charge Immunity ESD 4 kV contact 8 kV air CEI EN 61000 4 3 1997 11 Radiated electromagnetic fields 3V m AM 80 1kHz CEI EN 61000 4 4 1996 09 Burst Immunity test 1 kV common and differential power CEI EN 61000 4 5 1997 06 Surge Immunity test 1 2 kV common and differential power CEI EN 61000 4 6 1997 11 Conducted Radio frequency interferences 3V 80 AM 1 kHz CEI EN 61000 4 8 1997 06 Net frequency magnetic field immunity 3 A m 50 Hz CEI EN 61000 4 11 1997 06 Voltage dips and short interruptions reductions periods 30 0 5 60 5 100 250 CEI EN 61010 2 1 2002 01 Safety test prescriptions for electrical equipment for measure control and laboratory Part 2 101 Particular prescriptions for medical devices for in vitro diagnostics IVD CEI EN 61010 1 2001 11 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements 1 We intend standard references including relative changes at the date of the present document With the present document we declare that the specified product is conform to the above mentioned standards and it satisfies the essential requirements by the
54. f for example you notice that in some consecutive batches obtained results are have to be corrected with a factor of 1 12 you can apply this factor directly to the k factor of the method This window allows you also to print export save corrected results and restore old one In the case you select patient in main result window the following window appears BIOCHEMICAL SYSTEMS INTERNATIONAL Page 34 of 100 FULLY and FULLY SMART User s manual ed i Resut_ UR Flsg_ Reference Mote Cholesterol mL j 3 3 5 Print pepooes Offline Modify Restore valus E sit The available informations are the test performed on that sample the results the unit reference values and the notes about the results e g if the value is pathological Print button allows you to print all the displayed results Reprocess it let you reprocess the sample Offline It let you insert an offline test in the list Modify It let you modify a selected result Restore Values restore all the modified results The Find button in the result window opens the results search engine window BIOCHEMICAL SYSTEMS INTERNATIONAL Page 35 of 100 FULLY and FULLY SMART User s manual To find the desired results you can insert some search criteria like the date in whom you want to search the results the dates between whom you want to search the desired test and the patient s surname and name At least one of this parameter should be pr
55. f 100 FULLY and FULLY SMART User s manual 90 90 0f AA ONIENL Tie ss IE w a SMY wag PX NODTIS WIpZ2 BL MY EEE WUD eXL NOJMIS SZ y w09 NOJAL Mias 8 txa NOMS a 66 IMN VA Lug Xt NONIS LNIOf LU ALSYN W09 NOSAL WOL YX NOINE JAN 3UIVISINJd AVEO Page 81 of 100 BIOCHEMICAL SYSTEMS INTERNATIONAL FULLY and FULLY SMART User s manual ERROR MSG CAUSE amp SOLUTION Pump calibration value gt 1 6 Aspiration needle is obstructed clean necessary from top to bottom Check the aspiration tube B if properly connected to flow cell Too long time depleting washing cup bigger than Aspiration needle obstructed 20 seconds Check the proper insertion of the washing well in its housing between test and test washing or during initial Volume calibration required washing Air bubbles in to the cuvette Flow cell is dirty need washing with deprotenizer agent Check tube size 110 to 125 and air gap value Peristaltic pump calibration needed Aspiration needle obstructed Volume calibration may be required Volume calibration R1 not present put R1 strip in the strip carousel Error R1 not present or air into the dispensing Air inside dispensing circuit always make a diluter priming before performing circuit volume calibration Dispensing needle obstruction clean from top to bottom following the cleaning needle procedure Prime diluter Perform volume calibration If i
56. f calibrators and controls Inserted explanation of predilution handling in Workplan 18 08 03 06 03 06 Inserted explanation for holders of tygon tubes Peet e es 29 05 06 Inserted explanations about Line feed with F12 and linear correlation post dui processing of results Inserted note about blohazard risk Integration with software release 1 09A a 30 06 06 ee for new hydraulic circuit diagram 29 01 2013 Corrections about Warnings and Flags 23 12 14 Upgrade for software version 2 00 05 02 2015 Upgrade for new version of FULLY with external PC BIOCHEMICAL SYSTEMS INTERNATIONAL Page 4 of 100 FULLY and FULLY SMART User s manual WE RECOMMEND YOU TO READ THIS MANUAL VERY CAREFULLY BEFORE YOU BEGIN TO USE THE INSTRUMENT IN THIS WAY YOU WILL INSTALL PROGRAM THE OPERATIONS AND MAINTAIN THE INSTRUMENT IN A MUCH EASIER WAY AND YOU WILL GET THE MAXIMUM BENEFIT FROM IT BEFORE USING FULLY FOR TESTING SAMPLES YOU HAVE TO CONFIGURE THE ENTIRE SYSTEM TO DEFINE METHODS AND TO CALIBRATE AND VALIDATE METHODS IF YOU NEED FURTHER ASSISTANCE PLEASE CONTACT YOUR DISTRIBUTOR OR OUR INSTRUMENT PLANT BIOCHEMICAL SYSTEMS INTERNATIONAL VIA B BUOZZI 253 50013 CAMPI BISENZIO FIRENZE ITALY PHONE 39 055 8963140 FAX 39 055 8997086 EMAIL biochfi biosys it YOU CAN ALSO VISIT OUR WEB PAGE www biosys it NOTICE Every effort has been made to avoid errors in text and figures however Biochemical Systems International Srl
57. f the test the control number the lot number the number of samples and the date start and end relative to the controls Under these data a graphic appears you can choose if you want to see the Cumulative graphic in order to see the precision of the tests you are performing or the Shewart in order to see the accuracy of the tests On a little window on the right of the graphic the data relative to the test appear If you click on one data a square around it appears on the graphic Under the graphic statistical data will appear average SD CV Minimum and Maximum value If you click on the Setup button a new window will appear you can push on Set button in order to insert the data Average and SD you find in the control leaflet Otherwise you can push on Calculate and insert the period you are interested in if you want the instrument to calculate the average and the SD BIOCHEMICAL SYSTEMS INTERNATIONAL Page 30 of 100 FULLY and FULLY SMART User s manual Result If you click on Results button on the Main Menu the following window will appear Report f By test C By patient 06062005_0 met 26052005_0 met 19052005_6 met 19052005_5 met 19052005_4 met 19052005_3 met 19052005_2 met 19052005_1 met 19052005_1 metbak 19052005_0 met 18052005_5 met 18052005_4 met 18052005_3 met 18052005_2 met 18052005_1 met 18052005_0 met 17052005_0 met 16052005_6 met 16052005_5 met 16052005_4 met 16052005_3 met
58. ge 54 of 100 FULLY and FULLY SMART User s manual ALBUMIN Ms ie F siele ml ee Ed Stay F stida N Std8 Partial Calibration Io Stat FS Gigs stds Stdi0 Click on calibration flag to select if you want to perform or to skip calibration for this test in current session Your choice won t change general setting of the method You can also choose how many replicates of calibrator you want to perform in this section If you selected a control following window will appear ALBUMIN o ASPARTAT AMINOTRANSFERASE CHOLESTEROL In this window you can modify for this session only settings of control s reading for each test which have a control to be read BIOCHEMICAL SYSTEMS INTERNATIONAL Page 55 of 100 FULLY and FULLY SMART User s manual Cancel button Press this button to return Main window without enabling Tray Setup button OK button Press this button when you have finished examining the window and you think everything is right Print button press this button to print out the tests sequence Reset button this button allows you to start the allocation of tests from the first reaction well If you do so please remind to change the dirty reaction wells strips From Last button press this button if you want to start the allocation of tests from the last dirty reaction well Fix Sample Position check box if checked every sample will maintain the same position according to workplan line number If not the inst
59. ge 61 of 100 FULLY and FULLY SMART User s manual 9 Status Monitor STATUS MONITOR window allows you to have all the informations you need about reagents samples and reaction wells This window appears as follows Status monitor Of Status Running Temperatures table Stat No sample Pa Cc Flow cell By OC LO Reaction wells Mo temp ke Preheater Mo temp el el Jel Jel Je Je i T ke ke 1 19 15 13 11 2 Lel _4 On top left you find informations about current status of the instrument and current status of STAT mode in this case you have No sample because no STAT samples have been requested In the middle of the window you have the picture representing sample tray To have information about a sample click on its circle in the picture to select it and then click button INFO on the right a small window will give you all the information about the sample In the same way you can view informations about a reaction well if the test is kinetic you can follow the reading of the test real time through the graphic which is continuously updated Next picture shows an example BIOCHEMICAL SYSTEMS INTERNATIONAL Page 62 of 100 FULLY and FULLY SMART User s manual Well number 127 GEEEEEEEEEE eee eee Pipe 30 HA 290 210 BETA EKOE REISE EEEEE IE REED EE Ea T 10 20 30 40 50 Owner SamplelD 1 ANDREA Test EER O D Starting 0D 3 0
60. he first wavelength you need for the test Filter2 The possible second wavelength you need for the test In the Volumes ul section you can find the following spaces to fill Sample In this field you will write the volume of the sample you need Reagent I In this field you will write the volume of the reagent 1 you need for the test Reagent 2 In this field you will write the volume of the reagent 2 you need for the test In the Reading Parameters section you can find the following spaces to fill 1 Incubation In this field you will write the time for the incubation taking place in the reaction well For End Point Differential and Multistandard with postponed R2 dispensation this time is the delay that instrument should wait before it adds R2 2 Incubation The meaning of this field is different depending on the methodic In End Point Differential and Multistandard method only in case of postponed R2 dispensation you will write the time for the incubation of the complete solution taking place in the reaction well In Kinetic and Fixed Time methods this time is the period in whom the solution stays into the flow cell and it s read by the photometer Stability In this field you will write the period of time during which the absorbance resulting from the reaction remains unchanged Sample Replicate In this field you can write the number of replicates you want for each sample In the Results section you can find the f
61. he following icons Inside Session Work plan It let you prepare the wok list entering the samples ID and which test you want to perform on each sample See also chapter 6 Summary It let you see a summary table about the organisation of the work session Tray setup It shows you a figure with the samples and reagent trays and let you insert the list and the position of reagents you want to use Start It let you start the session of measurements Regarding how to create a work plan please see also Chapter 6 Work plan BIOCHEMICAL SYSTEMS INTERNATIONAL Page 25 of 100 FULLY and FULLY SMART User s manual Inside Report Patient data It let you associate the ID sample with the patient s name and consult the patients database Quality Control It let you see the results of Quality Controls Result it let you see the results of the analyses you are performing and of the previous sessions Regarding this part please see also Chapter 4 2 Report Inside Edit Method It let you archive view edit and print the test methods Profile It let you edit view and print a group of analysis e g liver kidney etc Calibrator It let you make a calibration inserting the necessary data Control It let you make the Quality Controls on the instrument Regarding how to edit a method or a profile please see also Chapter 5 Editing Inside Utility Setup It let you insert the user s customisation like languag
62. heck the flow cell clean it if it is necessary Bad aspiration into the flow cell Check if the aspiration probe may be dirty or blocked Check the tubing Check the movement of the aspiration arm Check if the probe is positioned correctly The peristaltic pump works correctly but the Check the tubing from the well to the flow cell and inspect if it aspirating when the washing well is not emptied peristaltic pump moves The silicon tube of the peristaltic pump may be damaged or badly set Check the integrity of the tube B The analyser cannot perform auto zero You Check if the micro flow cell is empty in case fill it with water obtain too low voltages after resetting Check the peristaltic pump tubing and change them if necessary Check the aspiration probe and its connection with cell There may be some leakage or air bubbles in the cell or the probe could be dirty The sampling of distilled water could not be correctly executed during the resetting Check if the wash solution container is empty Check if the photometer lamp is burnout Adjust the aspiration volume it could be too big or too little The results of the controls are out of range Check if the controls are analysed following the manufacturer methods Check if the parameters settings wavelengths temperature sample volume reagent volume and factor are correct Check if the water used for the controls is bi distilled or deionised Check if the reagents controls and standards ar
63. hing 5 Purge Flow Cell D Cancel In the Normal Range section you have to fill Low and High limits for male female and child In the window you have to write the Message you want to be printed in the cases the results are under or above the limits In the Predilution and Postdilution sections you have to choose the predilution or postdilution ratios In the Postdilution section you have also to edit Lineraity limit and Absorbance Limit Linearity limit when a concentration exceeds this limit an information message will be issued Type the value of the linearity limit of the programmed test expressed in concentration units 0 to 99999 If you do not select this limit the program does not perform any check Absorbance limit in kinetic and fixed time methods when the first value read for sample exceeds a limit an information message will be issued Type this limit value of absorbance 0 000 to 2 300 to BIOCHEMICAL SYSTEMS INTERNATIONAL Page 43 of 100 FULLY and FULLY SMART User s manual detect hyperactive samples It should be a minimum value for decreasing reactions and a maximum value for increasing reactions If this limit is not selected the program does not perform any check DILUTION The analyser is able to perform predilution and postdilution on samples according to parameters set in the method and to your setting in workplan module see chapter 6 for more details PREDILUTION Here you can set
64. ion and the recycling of such kind of waste When you have to dismiss a BSI instrument please don t throw it with normal rubbish but contact BSI or the authorized dealer Wasting should be performed in the country were the instrument has been sold Contact BSI at HeadQuarter Via G Ferraris 220 ZIP code 52100 Arezzo Tel 0575 984164 Fax 0575 984238 e mail biosys biosys it Internet www biosys it Instrument Division Via B Buozzi 253 Campi Bisenzio ZIP code 50013 Firenze Tel 055 8963140 Fax 055 8997086 e mail biochfi biosys it The label present on each instrument certifies that BSI complies with WEEE Directive BSI also assures that no one of the materials listed by RoHS Directive 2002 95 05 is used to build and assemble its instruments BIOCHEMICAL SYSTEMS INTERNATIONAL Page 94 of 100 FULLY and FULLY SMART User s manual APPENDIX 6 IMPORTANT NOTICE ABOUT BIOHAZARD RISK The following notes regard this label you find on the instrument Working with analytical instruments for in vitro diagnostics involves the handling of human samples and controls which should be considered at least potentially infectious Therefore every part and accessory of the instrument which may have come into contact with such samples must also be considered as potentially infectious Before servicing the instrument it is very important to thoroughly disinfect all possibly contaminated parts Before the instrume
65. ion is performed by the analyser for the duration of the 2 incubation time 11 2 2 Calculations in differential mode In the case of using a factor the concentration of each sample is calculated using the following formula Ce AR Ar s AR E Ari X K fact X RT In the case of using a single calibrator the concentration of each sample is calculated using the formula used above for calculations using factor but F is obtained in the following way C ois K fact EE EE EE A pocatib A pi catip me Ara me Any In the case of using several calibrators the concentration of each sample is calculated using a calibration curve obtained using the selected calculation function and axes A calibration curve is prepared using the programmed concentration values for the calibrators and the absorbance measured for each one Anc Artealib Aro Arib x RT The concentrations of the samples are then calculated by interpolation of their absorbance in the Curve Aros Ar s Ar Arip x RT In the case of the replicates you can choose to use up to three replicates for each sample calibrator or control The blank is always run for as many times as replicates have been programmed for the calibrators Replicates are treated in the calculations in the following way 1 First of all the mean value of the blank is calculated n meant Apo An Aros Any 3a i BIOCHEMICAL SYSTEMS INTERNATIONA
66. kaak eke ese seke Rae Re Re 86 APPEND Toe ee Di Ge OE ee Ge ee ee RD ee Ge ee Se GE EE EE EE GE Ee Ee 87 APPENDIX 2 ee ed ee Ge ee oe Ge ee ee ee ee ee Ge Ee Ge GE ON EE GE Ki EA Ee 91 Reference number in printout sesse sesse ees ee ee ee ee 91 Warning Message ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 91 eel ee N EO EO OE OR RE EE EE N OE ED 91 MUS oi N ER EE EE N 91 id ed NI Se EE EE EE EE OE EE RE N OE OE 93 AFPPENDIEA ER OES EG AE EE OE ee GR EE Ge Ge EG SE ER WE ER Ee ER Ge EE Ee OG ee 96 APPENDIX cs EN EE OE OE EE Ee N OE EE N EN EE 98 AFPENDDEGS ie ee n ee es ee ee ee be SE ee Ee oe oe ee EG ee ee 99 IMPORTANT NOTICE ABOUT BIOHAZARD RISK ee ee ee ee ee ee ee ee ee ee ee ee ee 99 AFPENDIE Doras ceca ee Go oe E Ee EG ee 100 BIOCHEMICAL SYSTEMS INTERNATIONAL Page 3 of 100 FULLY and FULLY SMART User s manual RELEASE HISTORY RELEASE DATE UPGRADE AND MODIFICATIONS 20 5 2005 Inserted explanation of serial communication 14 8 6 2005 Inserted explanations for STAT execution 2 Steps dispensing Status module Post dilution Samples Post Process Pause and error handling 15 6 2005 ee ees 12 2005 Inserted appendix about RAEE and RoHs directives Corrected Re ees ee images Corrected explanation of Absorbance limit parameter ME e 02 06 Upgraded complete drawing of hydraulic circuit Inserted explanation about Water Blank Purge Flow Cell in method editor Inserted explanation about modification o
67. l calibrators to obtain the sample concentrations 5 The mean concentration value of each sample is finally calculated l n II 11 2 Differential For this analysis method you have to use 2 reagents reagent 1 for the sample blank and reagent 2 for the overall reaction Each reaction mixture is incubated in separate wells and the absorbance of each one is measured at one single time You can base the calibration on the use of calibrators one or more or on a programmed factor The possibility to have the zeroing of the dilution and photometric effect of reagent 2 it is also given For this purpose the subtractive differential method should be used 11 2 1 Procedure in differential model The sample or the calibrator is pipetted together with the first reagent into a reaction well see Fig 11 4 The same sample or calibrator is pipetted together with the second reagent into a separate reaction well The reaction mixtures are incubated for the programmed period of time Each mixture is then transported to the cuvette and after the stabilisation time has elapsed the absorption is measured Note that the time required to move the reaction mixture to the cuvette as well as the BIOCHEMICAL SYSTEMS INTERNATIONAL Page 72 of 100 FULLY and FULLY SMART User s manual stabilization time are included in the incubation time If the 2 incubation time is programmed the reagent 2 is added after the 1 incubation time and an extra incubat
68. l session it belongs replacing the old result that was out of linearity In case you have a sample out of linearity limit the instrument will show a window similar to this one Samples out of linearity Samples to be reprocess for current session 23052005 6 E Chol Delete fror list gnore forever You can Delete from list The selected test will be delete from the reprocess list and will not be reprocessed Ignore forever The selected test will be delete from the reprocess list and the reprocess window will not appear in future for this kind of test Reprocess all list All of the content of the list will be inserted in the reprocess list and will be reprocessed the next session BIOCHEMICAL SYSTEMS INTERNATIONAL Page 64 of 100 FULLY and FULLY SMART User s manual 11 Measurements procedures and calculation This instrument let you perform measurements through the following methods End point Differential Fixed time and Kinetic In this chapter we will use the following abbreviations Absorbance of the sample fb Absorbance of the blank Absorbance of the calibrator C Concentration of the sample Programmed calculation factor RT Fixed factor depending on the programmed reaction type its value is 1 for increasing reactions and 1 for decreasing reactions Programmed concentration of the calibrator Number of replicates Ari Absorbance of the sample blank or calibrator with Reagent 1 sampl
69. le Check the connection of B tube with flow cell and aspiration needle for proper connection and leakage Check the peristaltic pump rubber grey tube Check the connection of A tube Check integrity of tube A and B Leakage from DISPENSING needle Check the connection of C tube with D tube Screw the joining to seal it Don t overthight Check the tube D connection to electrovalve Replace the O ring if necessary No need to tight excessive Selaing O Ring is present Excessive strength will damage permanently the Electrovalve Check integrity of tube C and D No aspiration from WASH BOTTLE Check the O Ring presence and integrity on the left side of electrovalve E tube Check the connection of E tube The probe does not aspirate sample and or The probe is not connected properly reagent If the module works correctly check if there are problems in the tubing and if there is enough washing solution in the container The probe does not dispense the solution into the Check the syringe it may be blocked Use washing program to purge the syringe reaction well Check if there is enough wash solution in the reagent container Check all the tubing from e valve to dispensing needle The test using a 3 ul sample size is not Check the sampling probe If it is dirty clean it If there are some scratches on it BIOCHEMICAL SYSTEMS INTERNATIONAL Page 82 of 100 FULLY and FULLY SMART User s manual reproducible change it C
70. lectrical signal and so read by electronics The optical system is slightly tilted to facilitate the elimination of bubbles eventually appearing into the flow cell BIOCHEMICAL SYSTEMS INTERNATIONAL Page 19 of 100 FULLY and FULLY SMART User s manual Computer and monitor Only for FULLY A TFT 15 all in one computer is located on the right side of instrument It could be assembled on a mounting bracket or left free on table according to user needs This PC has 2 serial port one reserved for analyser communication the other could be used for LIS exporting or importing Standard keyboard and mouse are supplied with PC 3 1 Technical specifications General characteristics Processing capacity up to 54 positions including samples calibrators and controls per tray in a work plan LiTncubation 1 21 to 9999 s Incubation 2 0 to 180 s Unlimited replicates for blanks calibrators and samples IH Calibration storing Patient data name age sex etc files demography data base QC Sample tray H Sample cup capacity 1 2 ml maximum ITray capacity 54 cups for samples calibrators and controls Reagent tray LITray capacity 20 reagent bottles of about 45 ml Reaction wells 312 rows with 12 wells each Reaction well capacity 1 ml maximum Reservoirs H Wash bottle 0 5 1 LY Waste bottle 0 5 There is also the possibility to connect to external waste tank It is necessary to extract the Tygon c tube
71. manual FI Layout Folders that contains analyser setting and personality files DO NOT LOOSE F Other files Compatibility Readme and Version file to trace software version changes To install software double click on Fully SW and expand folder to o DISKI di Upgrade DISK1 Contains all software to be installed from scratch new installation NOTE in case of software already installed If a software already is installed this operation overwrites all previous files resetting all to factory default value All database including result and patient will be lost and also layout and setting files Before re installing always rename the old folder c instrument in c instrument_old to preserve original layout file Upgrade Will perform upgrade preserving all data database results and settings BIOCHEMICAL SYSTEMS INTERNATIONAL Page 85 of 100 FULLY and FULLY SMART User s manual New Installation procedure DISK1 For a brand new installation you have to select DISK1 Then run if Fully Setup msi No backup operation are needed since it is a brand new installation Follow instruction till installation will prompt that you that is completed Once installation is complete you have to copy layout folder provided in USB pen drive to your local installed folder In fact the analyser is not centred the arm cannot reach exactly sample cups reagent tray reagent bottles and washing station To centre it ins
72. mmended Hard disk 320 GByte As Fully or above Operating system Windows 32 or 64 bit Windows 32 or 64 bit Serial port 2 COM port 2 COM port 1 for analyser 1 for LIS USB 4 USB port 2 x USB 3 0 2x USB 4 or above 2 0 LAN RJ 45 network adapter for LAN RJ 45 connection10 100 1000 Mbps WiFi 802 11 b g n Not necessary Display Touchscreen 15 TFT 15 or above Touchscreen if necessary Power 65W Unspecified Speaker 2 x 1 5 Watt Unspecified Camera 1 MPixel Unspecified Microphone Built in Unspecified Physical dimensions FULLY AND FULLY SMART 680 wide x 720 large x 530 high mm I Weight 55 kg Electrical requirements E 115 230 VAC 15 autosense 50 60 Hz 350 VA BIOCHEMICAL SYSTEMS INTERNATIONAL Page 23 of 100 FULLY and FULLY SMART User s manual Assistance to users IH Automatic selection of the calibrators and controls required for a work plan IH Automatic selection of the reagents required for a work plan Dialogue screens Windows for programming preparing work plans presenting reports etc Automatic alert messages on the screen Graphics F Calibration and Kinetic curves H Quality Control Levey Jennings BIOCHEMICAL SYSTEMS INTERNATIONAL Page 24 of 100 FULLY and FULLY SMART User s manual 4 Method of operation 4 1 The main menu When you double click on the Fully icon you will see the following screen In this screen you can choose between t
73. mpossible because priming is needed make diluter Needles bump into the washing well prime without washing cup Dry manually the washing hole put again the washing cup and make volume calibration now the hydraulic circuit is filled properly High CV low precision repeatibility Dispensing needle obstructed clean from top to bottom according to cleaning Diluter drift observed for same sample needle procedure Use washing solution perchloric acid 50 diluted or pepsine based solution for clean dispensing needle use special clean dispensing needle program in MAIN gt utility Linearity test out of 3 max error Adjust offset of preamplifier board through Dark current setting procedure Check for obstruction in the needles Perform a flow cell washing Volume calibration is needed to adjust minimum residual volume Use tap water well water from pipe because it 1s 10n1zed well Clean the washing tank by flushing with current water First sample underestimation in kinetic test Kinetic reagent is too cold despite of the preheating Solution wait 10 minutes GOT GPT more with the reagent inside the instrument before performing test The cuvette is cold due to the previous washing cycle increase the 1 incubation time Check the temperature of the washing solution If too cold may influence the flow cell Increase reaction volume Use Purge flow cell option in method programming between test and test Leakage from ASPIRATION need
74. n of each sample is calculated using the formula used above for calculations using factor but F is obtained in the following way K fact Cstd D B C A x Kea x RT 11 3 Fixed time For this method the absorbance of the reaction mixture is measured at two fixed times Only one reagent can be used You can base calibration on the use of calibrators one or more or on programmed factor 11 3 1 Procedure in fixed time mode The sample or calibrator is pipetted together with the reagent into a reaction well The reaction mixture is incubated during the programmed period of time incubation 1 The mixture is then transported to the cuvette and after the stabilisation time has elapsed a first measurement of the absorbance is taken Ar Note that the time required to move the reaction mixture to the cuvette as BIOCHEMICAL SYSTEMS INTERNATIONAL Page 75 of 100 FULLY and FULLY SMART User s manual well as the stabilisation time are included in the incubation one time The reaction mixture is further incubated into the cuvette for a second period incubation 2 and a new measurement of the absorbance is taken Ar A blank is always prepared for each test using distilled water instead of the sample and reading against a baseline of water at the same fixed times 11 3 2 Calculations in fixed time mode In the case of using a factor the concentration of each sample is calculated using the following formula C An
75. n will open Patient database to add new patients Summary table window This window is the result obtained by the process of the Work plan Manager Data window and you can see it clicking on the Summary button on the Main Menu BIOCHEMICAL SYSTEMS INTERNATIONAL Page 53 of 100 FULLY and FULLY SMART User s manual fe summan table x a SE RS Se eS Requred sips 7 Print Mody Fiesel Fiom Last Optimization On the left of this window the Execution Sequence appears In it you can find the kind of test on what the analysis will be done if it is a sample a blank or a standard and the ID or the name relative to the sample In the Calibrators part you can find the name of the calibrators and the volume of each of them which is necessary for the test In the Controls part you can find the name of the controls and the volume of each of them which is necessary for the test In the Sample Volume part you can find the name or the ID relative to the samples and the volume of each of them which is necessary for the test In the Reagent Volume part you can find the name of the reagents and the volume of each of them which is necessary for the test Modify button Press this button to modify settings for one calibrator or one control After you have clicked the one of these you want to modify press this button If you selected a calibrator following window will appear BIOCHEMICAL SYSTEMS INTERNATIONAL Pa
76. ndow you choose to optimize end point tests execution STAT samples will be processed later than without optimization because optimization rearranges tests execution in order to minimize time and instrument cannot interrupt soon routine execution BIOCHEMICAL SYSTEMS INTERNATIONAL Page 58 of 100 FULLY and FULLY SMART User s manual When the instrument is ready a message box will ask you to place samples and reagents in their own position When you are ready click on START button the instrument will perform STAT samples reading and the light indicator will be now red Before and after the execution of STAT modality the instrument wash needles and tubing to prevent any contamination When the instrument has processed all the STAT samples it automatically resume routine session from the break point It is possible to enter in STAT mode how many time you need the only limitation is given from free positions available on sample tray BIOCHEMICAL SYSTEMS INTERNATIONAL Page 59 of 100 FULLY and FULLY SMART User s manual 8 Pause and error handling If you need to stop temporary the instrument for example because you forget to place some sample cups in their own position press the STOP icon button in Main window it s the same button for START icon which changes depending on instrument s status After you click the button a little window appear Do you want to STOP or PAUSE X D m STOP Cancel Choo
77. nt is removed from the laboratory for disposal or servicing it must be decontaminated Decontamination should be performed by a well trained authorized person observing all necessary safety precautions Instruments to be returned must be accompanied by a decontamination certificate completed by the responsible laboratory manager If a decontamination certificate is not supplied the returning laboratory will be responsible for charges resulting from non acceptance of the instrument by the servicing center or from any authority s intervention Should you have any questions please do not hesitate to contact us Head Quarter Via G Ferraris 220 ZIP code 52100 Arezzo Tel 0575 984164 Fax 0575 984238 e mail biosys biosys it Internet www biosys it Instrument Division Via B Buozzi 253 Campi Bisenzio ZIP code 50013 Firenze Tel 055 8963140 Fax 055 8997086 e mail biochfi biosys it BIOCHEMICAL SYSTEMS INTERNATIONAL Page 95 of 100 Constructor Instrument Production year Applied standards FULLY and FULLY SMART User s manual APPENDIX 7 CONFORMITY DECLARATION Biochemical Systems International S r l Via G Ferraris 220 52100 Arezzo Italy FULLY FULLY SMART 2003 FULLY 2004 FULY SMART CEI EN 61000 6 3 2002 10 Electromagnetic Compatibility EMC Part 6 3 Generic norms Emission for residential commercial light industry environment CEI EN 61000 6 1 2002 10 Electromagn
78. of 1000 ul with 1 ul steps The dispensing circuit is filled with water When dispensing the transfer arm moves to the reagent and the plunger of the syringe displaces backwards to aspirate the arm moves then to the sample and again aspirates The arm finally moves to the reaction well and the plunger of the syringe displaces forward dispensing the aspirated liquids During this process the needle is washed in the wash station after each aspiration of the liquid Wash station It consists of a removable plastic cuvette located in the upper part of the case The wash station 1s filled with water when the instrument is started and will be used to wash the external surface of the needles as well as to wash the sipper circuit and cuvette Sipper system The system consists of the broader needle the tubing connecting the needle to flow cuvette and the tubing connecting the cuvette to the waste bottle through the peristaltic pump tubing The peristaltic pump performs the job of sipping and transporting the liquids to be measured Optical system The instrument 1s equipped with a filter photometer The filter wheel holds up to seven filters and a free position A stepping motor executes the selection and positioning of the filter The light beam passes through the input optics to focus the light and through the interference filter selected after passing through the cuvette The light beam finally reaches the photodiode where is converted to an e
79. of Fully is closed The Edit boxes allow you to customize report printed by the instrument In the Photometer section there are some flags which concern instrument functioning during work session Print initial O D reference values enable automatic printing of reference values calculated at the beginning of each session Auto save QC data allows to save automatically results of control serums in the CQ archive Use primary tubes allows you to use primary tubes for samples instead of standard sample cup of Fully Automatic optimization of worklist allows you to open summary module with optimization flag enabled see section 6 for details about optimization flag Load samples without stopping avoid that instrument stop itself to ask for STAT samples and reagents before performing STAT readings see section 7 for more details about STAT In the Language section you can select language for the software In the Hardware section you can edit some parameters which concern communication with internal external pc and with host computer do not modify these parameters without calling service before BIOCHEMICAL SYSTEMS INTERNATIONAL Page 38 of 100 FULLY and FULLY SMART User s manual 5 Editing programs 5 1 How to edit test methods When you click Method in the part Edit of the Main Menu the following screen appears e Method editor 5 a 2IEN ol 2 sa Supervisor Supervisor ee Mody Modify Eeer Te
80. ollowing spaces to fill regarding printing options Measure units In this field you will choose the measure unit you prefer for the results N decimal In this field you will put the number of decimals you want in the result Min Conc In this field you will write the minimum concentration below which every result will be considered equal to it e g if you put 10 and the result obtained by the instrument is 8 the shown result will be 10 The Replicate Blank check box allows you to repeat the blank reading blank is repeated a number of times equal to sample replicate field The Water Blank field available only for End Point Differential and Multistandard allows you to execute blank reading aspirating a volume of distilled water from Dilution bottle position D The volumes aspirated for blank preparation depends on the test to be executed as explained in following table BIOCHEMICAL SYSTEMS INTERNATIONAL Page 41 of 100 FULLY and FULLY SMART User s manual EP MSD with 1 Takes a volume of R1 equal to the sum Takes a volume of R1 equal to reagent reagent of reagent volume and sample volume volume plus a volume of distilled water set for the test equal to sample volume EP MSD with 2 Takes a volume of R1 equal to the sum Takes a volume of R1 equal to reagent reagent Single of reagent volume and sample volume _ volume plus a volume of distilled water step preparation set for the test plus set volume of equal to s
81. ord to edit the tests View It let you visualize the current parameters for the selected method Minus sign It let you remove a separator line Plus sign It let you insert a separator line Add It let you edit new tests A new screen will appear and you have to fill the parameters associated to the test Modify It let you modify the parameters of an edited test You have to select a title in the list of edited tests and then press this button Delete It let you cancel an edited test You have to select a title in the list of edited tests and then press this button Copy It let you copy the selected row of the list BIOCHEMICAL SYSTEMS INTERNATIONAL Page 39 of 100 FULLY and FULLY SMART User s manual Paste It let you paste on an empty row the row previously copied Some of the buttons can be enabled only logging in through Key 8supervisor button When you click the View button the Editing Test window appears In this case you can see all the parameters set for the selected test but you can t modify them If you click Options button you will open the Parameters Option Window for a detailed description of both window see below If you want to edit a new test modify an existing one or delete it you have to log in as supervisor When you click New the Method Lists window will appear so you can choose the method you want for this test Once you have chosen it the Editing Test window will appear the same window will a
82. ppear when you click Modify button Editing test Test Description ALBUMIN Test ID ALB Position E Manufacturer E xpire Mode EndFoint Note serum or plasma Wavelength rim Molurmes L m r Reading parameter Rg r Result Measure units g dL at incubation 300 Filter 1 546 senile E Decimal paint 2 And incubation Reagent 1 500 Minimum Conc Filter 2 stability 1800 Reagent 2 Sample replicate li ee C Decr ts rer Function Line Logit Log Calibration C KFactor Multiple i f Specific Each Session F Cancel Options N standard i Is l ja Replicate 2 4 Offset m Honto senim In the Test part you can find the following spaces to fill Description In this field you will put the test name Manufacturer In this field you will write the name of the test kit manufacturer TestID In this field you will put the test ID Position In this field it will appear automatically the position of the test in the Test List Expire in this field you will write the expire date of the test kit you are using Mode In this field it will appear automatically the test method Note In this field you can put notes about the test BIOCHEMICAL SYSTEMS INTERNATIONAL Page 40 of 100 FULLY and FULLY SMART User s manual In the Wavelength section you can find the following spaces to fill Filter T
83. rument will compact the samples Optimization check box if checked the software will rearrange the scheduled execution sequence to minimize execution time A statistic approach is used to optimize the execution of End point and Differential test the order of test execution will be changed to minimize dead times for the instrument Obviously Optimization will delay the possible execution of STAT samples because in this case the instrument will postpone STAT execution more than in normal situation to perform the scheduled test and optimize execution time On the left bottom side of the window the software displays how many reaction strips you need to perform the scheduled tests Tray setup If you click the Tray setup button on the Main Menu the following window will appear BIOCHEMICAL SYSTEMS INTERNATIONAL Page 56 of 100 FULLY and FULLY SMART User s manual gt Sample tray positioning Reagents positioning Reagents u Pata i A20 E Ca Ais Bioma san PROT Al Fom D F1 e000 5500 meje F SE Baie Be N Ae Pa FEID R1 Aid sgg hBiID F2 ae 4 z IURIC a 3 413 URIC jso IK 12 HEID R2 340 IE ME IEE ed Alb A11 HEID PT e000 Bip RY Es Bil D F2 10 IF 5500 ih AE z GPT amp Ag Mg 5500 e AB hGLUC 10500 L TRIG IE S5000 g FeiLr ier po ad FEIT RT feo aa EE Ee AZ ACETI R2 jo at BcETTRT fO ne iong Rack seup ER Print l Cl iy Cancel Load Be Sh
84. s Atis Ar2 gt ATip X K fact x RT In the case of using a single calibrator the concentration of each sample is calculated using the formula used above for calculations using factor but F is obtained in the following way ORT Kfact 5585950 Apo catib me Africa car E Ars In the case of using several calibrators the concentration of each sample is calculated using a calibration curve obtained using the selected calculation function and axes A calibration curve is prepared using the programmed concentration values for the calibrators and the differences of absorbances obtained for each one Arrcatib Aricalib At2p ATi x RT The concentrations of the samples are then calculated by interpolation of their absorbance in the curve Ans Atis Ar2p ArTib x RT In the case of the replicates you can choose to use up to three replicates for each sample calibrator or control The blank is always run for as many times as replicates have been programmed for the calibrators Replicates are treated in the calculations in the following way 1 First of all the mean value of the blank is calculated BIOCHEMICAL SYSTEMS INTERNATIONAL Page 76 of 100 FULLY and FULLY SMART User s manual 1 n mean Ars Ar gt Ara Ari n i 2 The absorbance difference of each sample or calibrator when used replicate is calculated in this way Ars or calib A TIs or calib 3 The mean value of the blank diff
85. se if you want to stop definitely the instrument or if you want just to call a pause for it If you choose Pause the light indicator near Pause label on Main window will become green until the instrument will be ready to enter in pause mode then the light will be red When the instrument has the possibility to enter in Pause mode compatibly with the operations performed the arm will return in the home position and a little window will advice you that the instrument is in pause click RESUME button when you are ready to continue the session execution Just remind that too long pauses could cause the instrument to read a test out of its stability time The instrument has a similar behaviour when during the execution of the test encounter an error like one of these WA sample cup is empty or not present WA reagent bottle is empty or not present IHA reaction strip has not been placed so the instrument can t find the solution to be read and probably it has dispensed the solution under the sample tray through the hole iy The wash tank is empty The waste tank is full BIOCHEMICAL SYSTEMS INTERNATIONAL Page 60 of 100 FULLY and FULLY SMART User s manual If one of these event happens the instrument will stop and a message window will explain the problem so you can easily solve it and then click REPLY button to let the instrument continue the execution of tests Heed more solution BIOCHEMICAL SYSTEMS INTERNATIONAL Pa
86. sult In the bottom part the following buttons are present Patient list gives you the possibility to see the list of the patients of that session If you click one ID and then View you can see the tests performed on that ID sample There is also the possibility to print this tests Save Ctrl if you click here you can save the controls if it is not automatic by the configuration Modify standard if you click here it will appear a window with information about the blank and the standards You can modify one value clicking on in and then digit in the Modify part and then click Apply You can modify also the kfactor digitising on the k factor part and then click Apply You can also exclude one value clicking on the value and then on the Except button 1f you want to include it again you can click on the Include button Kinetic curve it let you see the graphic see next picture as example BIOCHEMICAL SYSTEMS INTERNATIONAL Page 32 of 100 FULLY and FULLY SMART User s manual Readings Intervals OD leeg 2 46 16604 70 2 25 1 16610 77 2 43 1 16620 37 2 56 1 1651 2 1641 6 1631 3 Readings 120 Intercept f 660 95 Intervals 3 slope 2 45 Print Valid intervals 3 Delta Abe min 147 34 Print it let you print the results Except it let you exclude a selected result from the calculation for example if you think that is uncorrect because a bubble was in the cuvette Clicking the button
87. t COM potamni E aud Fate Delay ms COM Port gt ie Baud has 8400 Y evel h Eam Fat Simulation Enable Except PID DE Cancel BIOCHEMICAL SYSTEMS INTERNATIONAL Page 8 amp of 100 FULLY and FULLY SMART User s manual APPENDIX 2 WARNING MESSAGES AND FLAGS ON RESULTS Next table shows the meaning of warning messages that could appear in results list see chapter 4 2 Could be a number Reference Warning Message number in printout Temperature high Temperature was over 37 5 C Temperature low Temperature was under 36 5 C Over high limit 2 7 Over high limit OD higher than high limit of the curve Under low limit OD lower than low limit of the curve 3 time was over 6 da N eas Sample has been read before first incubation time No linear Kinetic Kinetic test is not linear 2 intervals are 25 outside the linear regression of the total points 9 Blank error End Point Blank error Absorbance of blank is less Differential than O or blank has been taken with air Multistandard bubble inside the cuvette Fixed Time 11 Sample prediluted Sample has been prediluted Sample postdiluted Sample has been postdiluted 12 13 Residual volume high ALL Level sensor sensed liquid after aspiration from well Possible bubble inside flow cell Or a flag FLAG Result is under lower limit or over higher limit for the test R Sample reprocessed R
88. to a LIS Since Fully has not serial port output provided in the external port a standard USB to serial adapter can be used in order to convert USB port to serial USB to RS 232 converter PC with instrument application software embedded inside LIS server HOST For a description of the protocol of LIS contact Biochemical Systems International or your authorised local distributor BIOCHEMICAL SYSTEMS INTERNATIONAL Page 92 of 100 FULLY and FULLY SMART User s manual APPENDIX 4 Assembling PC bracket to the instrument If you purchased Fully with panel PC see this appendix to assemble the bracket to the instrument STEP 1A With a screwdriver unscrew the four screws that fix the stirrup to the bracket BRACKET STIRRUP STEP 2A Fix the bracket to the instrument as shown in the picture below A DO NOT USE THE SAME SCREWS THAT YOU TAKE OFF IN STEP 1A Use four screws M5x16mm with elastic washer that you find in a box A eu da OT EG a oe SCREWS IN BOX A M5X16 ELASTIC WASHER BIOCHEMICAL SYSTEMS INTERNATIONAL Page 93 of 100 FULLY and FULLY SMART User s manual APPENDIX 5 WEEE and RoHs Directives BSI complies with WEEE EC Directive 2002 96 CE about recycling of electrical and electronic equipment waste This EC Directive forbid to collect no more used electrical and electronic equipment waste with normal rubbish and entrust the producers the collect

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