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for Chemi luminescence Immunoassay System

1. Check test item layoutu Viewi LDTest Item Check Sample No Layout View Sample No 7 5 Recheck Open saved layout information Method 1 File history Layout Information Method 2 Right click the mouse over layout area Open history Layout Informationl Run testUClick Begin test Click Run sign 7 6 Print test result Print test result Click Preview sign of tool you can print the test report if you want many page printing you can ClickUFile_i print print report freely 7 7 Save test result Save test resultLiSystem will save the test result automatically after each test the saved result is according to your parameter that setted in system setting 1 only save photons not analyze 2 analyze and saved result 3 automatically build the report preview 7 7 Review history record Review previous record File1 HHistory Review 8 Maintenance Daily maintenanceO Keep 96 well micro plate pallet clear Clear the joint of the door to make it closed well Weekly maintenancel Open the door and ventilate the equipment for 1 2 hours so as to lower the interior humidity Monthly m
2. Clicking the item that needs to be set in the left part of the window the item basic information will be shown in the right part of the window Item setting includes concentration of standard bottle unit standard point amount analytical method the range of reference value and use frequency choosing The program needs to be restarted after setting Use frequency choosing According to item use frequency items with high use frequency usually be set as default value and showed in the layout area for users convenience The range of reference value setting should according to the sequence of sex age low limit age high limit description refrence low limit refrence high limit Reagent bar code inputliSee picture14 tmy up AN E thems marcgewort Swock Er Ezme nwm eaka LOL ED aotro achibr gt ak gt iwo llah ap eb Picture 14 While inputting data put cursor in the bar code input area Scan three rows of bar codes Inputting bar code information by hand is also acceptable The program will analyze automatically if not please click Analyze button After confirming click Input Notice Before being used every new reagent box has to be scanned to update the databank The reagent bar code contains standard curve Therefore the standard curve in the databank will be updated automatically as long as the scanning is done After upd
3. It originated from MS Enzyme Chemiluminescence Immunoassay O0 CLIAU 80 Notice 1 Operation interference 1 1 Don t open the door while equipment is running 1 2 Don t start other program during the test 1 3 Once failure occurs stop test and conduct OPallet Out Continue the test when problem is fixed 2 Reagents and quality control material 2 1 Only use the reagents designated by MS to avoid possible damage to the unit or the influence to result 2 2 Use all the reagents within their valid period 2 3 Strictly follow reagents explanation to preserve and transport reagents 2 4 Don t mix up reagents with different lot number 3 Expendables 3 1 Disposable tips cannot be used time after time 3 2 Keep expendables clear 3 3 Use distilled water and diluents within their valid period 3 4 Preserve it under its original package condition 2 Sample preparation 4 1 Usually adopt vein blood collection Avoid sample hemolysis 4 2 Choose sample type according to reagents explanation 4 3 Preserve and treat sample according to reagents explanation 4 4 lf sample has been freezed it must be well mixed after thawing And never freeze and thaw the sample time after time 4 5 If there is granule material in the sample it should be removed by centrifugating Pay attention to the possible interference from hemolysis fat blood and others 4
4. according to the range designated by factory 6 4 Requirement for quality control 1 Run all the quality control points after each new lot number reagent is calibrated 12 for qualitative analysis or 3 for quantitative determination 2 Run one quality control point each day 7 1 Basic operation Shortcut Operation Fill 96 well Micro Plate Layout Information 7 Routine Operation Patient information input For research institution Right click the mouse to lock sample type According to196 well Micro Plate Layout Information or left click the mouse to choose an area to place it Save layout information Method 1 0File Save Layout Information Method 2 Right click the mouse over the layout area USave Layout Information Standard Operation Set a new casellUse shortcut or Files UNew Case Fill 1 96 well Micro Plate Layout InformationAccording to new case sample order in Micro Plate Layout Information For hospital left click the mouse once to place sample 96 well to H20 till A12 to H12 fill sample No and other information in
5. once all setting is done xi 8 Print Report See picture 7 mpe r pe T Temir m a r 8 1 FunctionUPrint report and report forms Nae i bos jm 8 2 Setti ng Choose needed items C Case No Name Gender Birthday SampleNo Item Name Result Doctor ExamDate 8 3 Items should be set first Then click search and information of the record that meet the above requirement will be displayed 8 4 Print all record iClickUPrint ReportLior Print Report Form 8 5 Print chose record Click needed record in the list and then click_iPrint Chose Report This function is only available for report output but not for report form output 8 6 If only to print current record you only click the preview 90Test Result Export See picture 8 26 Picture 8 View Check current plate information through click Photon Display Result Display Item Display Sample Type Display respectively at the right bottom ExportliFirst set file name choose a location and click Save to EXCEL Data process The program will export 4 EXCEL files and automatically open them which facilitates data statistics process 9 2 Export batch History information Te
6. report forms print etc 5 Reagent System All the reagent sets meet the requirements of quality control system and are certified by Food and Drug Administration 5 1 Item Categories Thyroid Function Procreation Internal Secretion Anemia Tumor Markers Congenital Disease Hepatitis AIDS Virus Heart and Blood Vessel Disease Diabetes TORCH Series Package 48 pieces box 96 pieces box Period of validity Reference the date printed on the package Usually 1 year Valid period since been opened iReference the date printed on the package Usually 60 days Reagent pretreatment No need Use the reagent directly after the room temperature reaches balance Bar code Inside there is pre saved standard curve and parameters for each reagent box determined by factory 5 2 Calibration Material 6 point calibration or 2 point recalibration curve Calibration frequency Only 6 point calibration is needed for the same lot number reagent Calibration s Stable period Reagents sharing the same lot number 5 3 Quality Control Material Period of validity Reference the date printed on the package Valid period since been opened Reference the date printed on the package Quality control frequency It is recommended to carry out the quality control daily Stability of the quality control Dynamic Tracing could be based on this stability Diluen
7. 6 Provide enough amount of blood according to explanation 4 7 Avoid sample bubbling or foaming 4 8 Only human sample can be used 3 Explanatory note for result All the test result should be evaluated and treated by combining clinic data such as patient symptom illness history related test data and other related information To make sure the accuracy of the test result sample with abnormal result should be retested It is also feasible to use other equipments basing on different methodology to retest the sample Installation Guidance Installation requirement Do not place the unit on an uneven or tilted surface Keep the unit away from heat resource or cold resource Don t expose to direct sunshine Enough ambient space is required Strictly follows the instructions N O Oo A OUO N System Self Test pey Check whether power supply is well connected and turn on system switch in turn 2 Check whether the GATE indicator light is lit when the door is open whether the GATE indicator light goes out when the door is closed as well as whether the equipment is closed tightly 3 Start system self test program and execute comprehensive test in accordance with O Daily Operation Manual 30 System Calibration If standard deviation in system performance is detected while execut
8. Check the equipment veracity and lineariry range with stable light source Check whether interface wire is well connected Clear mouse touch board Trouble shooting Door switch failure FailureU Indicator light remains light after the door is closed Solution 10 Check the joint of the door to make sure there is no eyewinker 2 iManually press the door switch and observe whether the indicator light is off 30Check whether the door switch works X axis position locating failure Failure X axis clashes when moving SolutionO Reset or turn off the equipment open the door and move the pallet by hand If the pallet is unable to be moved check whether there is any obstacle if it moves begin the test again If it still clashes open the equipment and check X axis position sensor Y axis position locating failure Failure Y axis clashes when moving or the pallet clashes when it comes out SolutionO Reset or turn off the equipment open the door and move the pallet by hand If the pallet is unable to be moved check whether there is any obstacle if it moves begin the test again If it still clashes open the equipment and check Y axis position sensor Optical fiber motion failure Failure Cross talk among adjacent wells is great or the sound of optical fiber motion cann
9. of validity 3 3 Check whether the reagents and quality control materials are enough 3 4 Dilute the lotion according to reagents explanation 3 5 To Check whether the expendables pipettes tips filter paper and recording paper are enough 3 6 If you use micro plate washer please start its initialization program after the lotion bottle is ready 4 Test item management 4 1 Add new test item A Bar code inputing Check whether there is the needed test item in the saved test item list If the list with out one saved add the new test item here OTooli Oltem and data settingi Testing item bar code input input the bar code gt auto running finish BU Input information Tooli Ultem and data setting J UTest Item ManagementUi select the item need to be modified modify exit gt OK Note if you are not reagent open customer this fuction will only suplly reference scope print scope and so on 4 2 Reagent open registration Tool iltem and data setting Test Item Managementl gt register write down the device number pop up from the window and fax the number to XMTZD and note that you want Reagent open you will get the authorization series number put in the series number enter concentration unit and analysis method of the test item
10. will become a problem So you can use a horizontal arrangement of the automatic 12 holes to be tested Pay attention to statements such as installation of air under the tacit consent If you need to print reports or statements that the results of this examination can only sample for this message Please print the contents to be completed here Aten 22a forse ogee Se ee ee Qop mee oe Be ge 42 4 r ee ee Orne cerdcneie te rho ind ebe ee peda wo ETETA Phoa tin 8 1 e gt A I bee are Zaans wp masra pe SIEUA ARILI ede Han LSL BL Fennel User manager Picture 18 The initial use s password is Admin that users have administrator authority can be any set up if the use of authority Guest user groups the other can be operated Only users install and management can not operate tags JE daw mgo fea pe a anh 1 Picture 18 13 2 Save as standard curvel See picture 19 Picture 19 Save the current 96 well micro plate standard sample information into the system standard bank If there already have such standard information in the bank then replace it The latest standard curve will be adopted in later analyses Standard information of each item will be shown in the window Select corresponding item in the drop down menu at the left top and then both standard information and graph of this item will be shown After confir
11. User for MS IIM MS II Chemi luminescence Immunoassay System Modified Date12007 2 1 Software Version 1 0 0 Signs User s Guide Company s Address Issue Date LEH IVD In vitro Diagnostic Medical Device Caution Storage Temperature esi Mark of Communities of European an fN Help Take safety precaution measures in case there is hazardous biologic waste Po Explanation Warning Please read carefully and operate in accordance with the user manual Attention We have tried our best to make every thing perfect Potentially errors and omissions are however virtually inevitable MS highly appreciates your advice on correction We will constantly ameliorate our product at certain period to improve the equipment s performance The details of this User Manual are subject to change without previous notification MS will provide the updated User Manual to her customers in the form of attachment in time Any suggestions either on product or on user manual will be awarded Company s name Medical Sources Co Ltd European Representative Shanghai International Holding Corp GmbH Europe Address Eiffestrasse 80 20537 Hamburg Germany User s Guide This User Manual is for Chemiluminescence Immunoassay System The number of photons can be read from the 96 well micro plate Therefore certain antigen or antibody co
12. aintenanceLiAll performance self test Position sensor stability and repeatability Check the equipment veracity and linearity range with stable light source Check whether interface wire is well connected Clear mouse touch board 9 About caution When failure occurs such as misoperation software problem and wrong result system will prompt warnings and detailed explanation Please follow all the instructions to avoid possible danger to yourself or others and damage to the unit 100 Power off Take out 96 well micro plate wipe fluid spattering on the pallet and close the door Put left reagent into its corresponding package and put it back into refrigerator Clear up operation platform and properly dispose wastes after killing bacterium Power off computer Power off printer 6 Test Standard Operation Rules 1 Reagents Main composition Solid phase coating antigen on 96 well micro plate Enzyme compound Sample diluents Concentrated lotion AUB chromogenic substrate 1 2 Preservation condition Preserve reagents and quality control material at 208 2 Parameter setting System is able to automatically set reagent parameter through scanning bar code on reagent package 3 Sample collection and preservation 3 1 Original sample type Blood serum or other body flui
13. and pasted that is if a area 3 x 3 is copied then this 3 x 3 area is pasted In a word the area sample is moved to another place 110View 0See picture 11 View sample information respectively in layout area Cut Ctrl x through choosing Copy Ctrl C different items Paste Ctrl y 11 1 Layout Information Display sample type in layout area Delete iSalPatientU St Standard OBLOBIank Well QciQuality Clear all Picture 11 Control Material 11 2 Photon AmountLDisplay tested sample photon amount in layout area 11 3 Test Result Display tested sample concentration in layout area 11 4 Test ItemU Display sample s test item layout in layout area 11 5 Sample No Display the layout of sample No in layout area 12iTest Menu 12 1 RunLiAfter executing this function a window will pop up See picture 12 xl 0 Start Num Sort RLU Property Picture 12 All the sample information in the current layout area is shown at the bottom of the window Carefully check sample No position test item and its amount After confirming click Start Then wait till the test finishes 12 2 Analyze This is for current test result analysis or history record analysis After executing this function a graph of analysis and reference
14. ate Layout Information put reagent blood serum standard material and quality material into corresponding well And incubate them within required time under normal temperature or 370 7 Micro Plate Wash 1 After incubation finishes wash micro plate by hand or use micro plate washer 20Dry 96 well micro plate with filter paper when washing is done 8 Luminescence Reaction Put equivalent A and B chromogenic substrate solution into each well of 96 well micro plate from A1 to H1 A2 to H2 till A12 to H12 9 Test 15 minutes later since chromogenic substrate solution is added into the first well put 96 well micro plate into equipment and close the door Run test program Check and confirm the sample list in pop up window again Then click StartLito begin the test 10 Print When test finishes click icon to print the test result 1 Program Description 1 1 1Hardware Requirement Operation Environment Daily Operation Manual CPU 800MHz Memoryli128M or above Free Space 1100M or above 1 2 Corollary Equipment 1 3 Software Windows98 or Windows 2000 XP 2 Bar code scanner with the support of Office2000 or above Software Installation The software is already installed in anal
15. ating standard curve every box of reagent just needs a two point calibration which facilitates operations and reduces the cost Before the access to reagent is opened reagent parameter can only be inputted by scanning bar code Registration of opened reagent access See picture15 xl Machine message ACHW7XENFUAANB Register message Picture 15 Cancel OK For those have received reagent access register as follows Click register button in the picture 14 and a window will show up picture 15 The upper column of the window shows the machine information code User should send the machine information code to the producer through telephone fax instant message toll email etc and also submit a application by fax After authorization the authorized information code will be sent to the user Put the received information code into the column below Click ok At the time another window See picture 16 will pop up indicating the successful registration Finally restart the program and input reagent information by hand System parameter Picture 17 Testing Process installed option after completion of the trial is necessary to preserve the photon number For further analysis is not necessary for the preservation depends on how you choose in addition Health costs automatic plate test records whether an advance copy of the report but also by you to determine Barcode reagent con
16. away from strong magnetic field strong electric field water resources and causticity liquid 4 2 Power Supply Power supply must be 220V 50Hz or 110V 60HZz Its groundwire should be well connected to the ground The voltage fluctuation shouldn t exceed 10 Otherwise voltage stabilizing device should be installed 50 Wastes Treatment Once test finishes sterilize the wastes and dispose them properly such as remaining fluid of plate washer reaction well plate tip etc avoiding harm to human or pollution to environment Standard Operation Rules 1 Purpose The system and its reagent sets are for ultra microanalysis quantitative determination and qualitative analysis of the chemical compositions of virus antigen antibody hormone peptide tumor protein metabolite and medicine in human blood serum and other body fluid 2 Applications amp Principles Technical Theory Enzyme labeled Chemiluminescence Immunoassay Technology Test Procedure 1 Competitive ELISA Solid Phase Chemiluminescence Enzyme Immunoassay taking micro plate as its carries follows the competitive methodology Antigen is coated in advance onto the wells of the micro plate After the test sample is added free antigen from the test sample and the HRP labeled antigen compete for the immobilized antibody binding sites on the wells Thus the immune com
17. d Reference reagent explanation for details 3 2 Sample amount According to different test items sample amount varies from 20 to 100uL 14 3 3 Patient preparation It is prohibited to use the samples of patients who received rat monoclonal antibody diagnosis or treatment since those patients have human anti mouse antibody HAMA which will lead to a pseudo increase or decrease in test result when the sample is tested with rat monoclonal antibody reagent For some special medicine concentration test both the valley value concentration and peak value concentration should be known Pay attention to the analysis with medicine interference iReference reagent explanation for details 3 4 Sample collection method Usually vein blood collection 3 5 Sample collection requirement Avoid excessive hemolysis Collection should be conducted under asepsis condition Make sure the centrifugal speed is 10000 round minute and the time is 10 minutes Avoid the interference from granular material Don t freeze and thaw sample time after time Thawed sample should suffer low speed oscillation or upside it down slightly and then mix well so as to obtain stable result When there is granule material red cell and other turbidity mixture in the sample please first centrifugate it and then begin the test 3 6 Sample s stable period and preservation Test should be finished within 3 hours since blood serum
18. ditions for the opening of registration and based on your company s needs whether open to the possibility 30 System parameters the need to explain the meaning of some of the parameters automatically emptied records list This new medical record for each will be emptied and all the new records before today s provisional data You are unlikely to affect the testing of test records test access to records from the historical record This means that if elections of this the new system will retain the provisional your records Reference to the scope of the report showed As a unit in a unit According to the different needs in reference to whether the scope of a further additional information by your decision but the amendments If printed out you need to re analyze and record keeping can be shown in the report single out Initialization of Pin4 7 This is your analysis to determine the type installed by the general staff will be able to better determine that the principal purpose of the instrument and whether the line 2 00 calibration conditions to be this if you open the case you every time you test analysis Printing plate when all the current projects must contain two or more than two standard before they can conduct tests computing or printing operation Automatic distribution of horizontal plate This is mainly targeted to the washer As part washer only horizontal washer and if we caused each of the eight hole vertical line washer
19. e known antigen concentration of the calibration materials standard curve is drawn and regression line is available via dual logarithm mathematical model Then the concentration of antigen present in the unknown sample can be calculated 3 Specifications 1LiHardware System 1X axis amp Y axis Plane Drive System Composed of X axis sensor Y axis sensor X axis stepping motor control X axis drive mechanism and 96 well micro plate pallet Its function is to cause the plane movement of the 96 well micro plate so as to make each sample well exactly orient to test site 2 iHardware System Photon Read Composed of such cells transferring as optical fiber movement photon accelerating high voltage dispatching and signal pretreatment Its function is to realize the optical isolating photon transferring light to electric conversion and signal figure processing 3 Hardware System System Control Composed of Y axis motor control low ripple power supply three dimensional drive control photon counting and operation as well as communication interface It is in charge of movement control data processing and data transmission 4 Hardware System O Embedded Computer System Only for MS IIM Series Made up of industry control embedded system Its function is to implement display data input instrument control fitting operation database
20. e only difference is that the analysis method is subject to selection that is a method can be selected to analyze the entire item in current plate This operation is only available for the sample analysis in layout area but the analyzed result won t be saved into databank 30Set New Case 3 1 Set new caseilliSee picture 3 hone ena o Miz x e i eee saij P Mee O _ xr p cx au P C E C v oi hosc Same gt Me ove aes a ore 3r we Picture 3 ER ZENH EEEN 3 2 Under iconORefreshG there is icon Show Allo which determines whether to show all the information or to only show basic information 3 3 The input of sample No and test item is necessary while the case No input is optional Only when Case No Name Birth Date and Gender of the test sample are all the same will system judge that this sample belongs to a certain person Hence it is recommended that user should input complete information 3 4 Input cases will be listed and be displayed from small to big in light of their No Please input sample No as follows Character 000 Starting Number Besides make the sample No be able to increase automatically and also leave enough room for its numeration e g A001 A005 A010 A016 etc 3 5 It is recommended to input hospital registration No in Case No Column since Case No is the only 24 id
21. entification for a patient If no registration No is available don t leave it blank but input serial no 3 6 Fill in remark with the information that the program fails to provide 3 7 Accurate birth date can be input in Age Column This function is especially useful for child under 1 year old For those aren t required exact birth dates just input their age 3 8 User can edit save or delete information by double clicking the list 3 9 More than one test item can be selected in Item Choosing Column thus avoiding bother of multi inputting Notice Data input here is only saved into system cache When the software is started the system will clear up previous data and only save the current data Once test is executed information in the list will be saved into databank 3 10 For more information status you can click more like the following picture For the information Hospital Dept Doctor item you can press function key F2 to save And you can press F3 to bring it out for editing Ivy el A a Maced Ir bee ads Late FOLTHOd Ze L2 40Data Save After changing analysis method or editing patient information we could save this modification into databank through the Data Save function 50History Call back See picture 4 x CaseNo PName Gender Bithday SampleN
22. ey decline to the ground state energy is released in the form of photons viz chemiluminescence The chemiluminescence system includes two types One creates chemiluminescence signal by enzyme and the other adopts non enzyme chemicluminescent labeling technique In the above mentioned first system commonly used chemiluminescence reagents are aminobenzene dihydrazide mainly luminol and isoluminol ramification and acridine esters The great success of chemiluminescence determination using isoluminol labeled biotin in 1976 led to rapid development of chemiluminescence immunoassay Besides the detection sensitivity is enhanced greatly and fleetly The chemiluminescence system commonly used in the past is as follows CO i OH light a 425nm ee NH N i CO umino _ NB O is NH activated by oxidizers to amido phthalate ions in the excited state It emits photons while declining to the ground state The chemiluminescence technology wasn t applied in the gene analysis and immunoassay detection field due to its low sensitivity until people found in the 1980s two kinds of materials namely 6 hydroxybenzothiazole amp its ramifications and phenols with two p substitutes such as p iodophenol and p phenylphenol These two materials can increase the luminescence intensity by more than a thousand times Besides they could also prevent background illuminescence caused by single reaction between oxidizers and luminescent reagents wh
23. iber Sample Input Port Sample Plate Light Isolating Unit Transfer Drive Unit Printer gt Computer j gt Port Controller Motion Controller Photon Counting Unit Data Processor Power Supply High voltage Generator 1 2 Components of Analysis System Composed of Computer Data Printer Port Controller Motion Controller Photon Counting Unit Fiber Transfer Sample Plate Drive Unit Data Processor Sample Send Port Power Supply High voltage Generator etc 1 3 Explanation for Each Component Sample Send Port The only exit between equipment and the outside Its function is to carry the sample and to prevent light away from the system Sample Plate Drive Unit In charge of sending sample to the test unit Fiber TransferiTransfer photon signal of single sample to Photon Counting Unit effectively avoiding the light pollution among samples Photon Counting Uniti Executing emitted photon signal collection and its pretreatment Motion Controllera Drive X axis and Y axis send test sample to its corresponding test place and control fiber motion and Location Sensor Port Controller In charge of serial data communication between equipment and computer High voltage Generator Provide Photon Counting Unit with 1400V DC voltage Data Processor Implementing data enlargement demodulation threshold c
24. ile prolonging the luminescence time by a few hours Generally the system requires using ALP and HRP The additional substrate illuminates under the effect of enzyme The luminous flux is determined by substrate The chemical reaction is as follow Light Emission Mechanism of CSPD o 0 0 0 0 H OCH Pere OCH cl A gt Light cl oro cl Oo a S In the nonenzyme chemiluminescence labeling system signal could be emitted in very short time because its background signal is small Generally chemiluminescence is able to accelerate the detection by ten times or even more or to improve the sensitivity by ten times or above 2 2Reaction Process Put quantitative body fluid and enzyme labeled substance into white opaque enzyme labeled plate which solid phase is coated with antibody Sample molecules and enzyme labeled substance will compete to combine with the antibodies on the solid phase Separate and wash the unbound components and add chromogenic substrate Then the enzyme induces the substrate to luminesce At the time put the enzyme labeled plate into the equipment and photon counting system will read the luminescence value of each well The sample molecule concentration is then calculated by the mathematics model constructed in the light of standard sample In the end the data report form which will assist clinic diagnoses is printed 2 System Description 10 Equipment Structure 1 1Structure Picture F
25. ing system self test calibrate it in accordance with Troubleshooting 4 Parameter Setting A System setting according to Test item amp system parameter management in Standard Operation Rules B Parameter file of the device Comm lic file you can Copy document comm lic and paste to Install directory It can run normally 5 Training courses for user Professionals from factory will hold training courses for users The courses include installation standard operation rules shortcut use method daily operation system maintenance troubleshooting etc Course that must be included Without consulting doctors users should not make any medical treatment related decision Course include Precautionary measures on wastes should be taken including the way of special disinfection protection and disposal Shortcut User Manual Precondition of this manual is that Equipment has been installed in accordance with lInstallation User has read Standard Operation RulesLThis manual is only for reagent researcher use and hospital operator use when they encounter emergency 10 Appliance Preparation Preparing pipettes with different measuring range and adjust them to frequently used range Preparing disposable tips that match with pipettes Preparing fi
26. is obtained Sample can be preserved for 11114 days at 2008 For long term preservation less than 1 year blood serum should be separated and be preserved below 10 4 Operation process No need to pre treat reagent It can be used after the room temperature reaches balance 5 Result calculation 5 1 Quantitative analysis Set up standard curve according to 4 parameter logistic curve fitting data and get sample concentration from standard curve calculation Set up standard curve according to spline approximation fitting data and get sample concentration from standard curve calculation 5 2 Qualitative analysis Get cutoff value from the average luminescence value of 2 negative and positive samples Cutoff OCO Sample average luminescence value 2 Sample result is obtained by letting sample luminescence value divide cutoff valued CoOL S COLLiSample luminescence value l Cutoff value 6 Report format See appendix I 7 Reference range for result analysis Reference each item s reagents explanation Set up normal value reference range according to practical cases of local people 8 Clinic significance Different items have different significance See appendix II 7 How does this system come out
27. ler in the need for the network database is necessary and the main database file compression FreeData mdb documents 13 5 Instrument calibration This is a function added to version 1 0 0 203 main purpose is to facilitate the installation or user use the standard source for this instrument calibration see picture 21 G ret rurcert Chrainn pe g i F E 7H Y awm Picture 21 Caa ha ee TIE evy y zt Mmethods of operation 1 The first hole to test the position 2 regulating gain coefficient 3 test the current photon 4 if photon test close to the standard photon 5 save the parameter to document 6 finish 13 6 Help You can press F1 to start the help document and also can clik help to start the document If bing out this interface see picture 22 that means the help document of software has lost or be damaged rein ot eee ee DAnte me eh ee ADAR eee coe Ce ee in YY Peres weet we Picture 22 33 Maintenance Manual Daily maintenance Wipe the 96 well mirco plate pallet to keep it clean Clear the joint of the door to make it closed well After test finishes power off the system and cover the equipment with dustproof fabric Weekly maintenance Open the door and ventilate the equipment for 1 2 hours so as to lower the interior humidity Monthly maintenance _iAll performance self test Position sensor stability and repeatability
28. lter paper for drying 96 well micro plate Preparing measuring cup beaker and distilled water for diluting concentrated diluents O a A W N Preparing airproof membrane for 96 well micro plate and0 96 well Micro Plate Layout Information 2 Sample Preparation Preparing well separated blood serum without turbidity mixture granule material hemolysis and fat blood 3 Reagents Preparation Take reagents from refrigerator and wait till room temperature reaches balance About 15 minutes 4 Equipment Preparation 10 Turn on printer and equipment power supply 20 Door indicator light will change when the door is open and is closed Place blank well BL randomly in layout area and run the test When the test finishes the luminescence value of BL should less than 50 RLU 5 Sample Layout 10 Fill in 96 well Micro Plate Layout InformationUwith sample number 20 Set sample in the program layout area in accordance with 196 well Micro Plate Layout Information Use the left button of the mouse to lock sample type and then left click the mouse to draw an area to set the layout S 3 1 If there is more than one 96 well micro plate click icon g to save layout information in turn 6 Sample Treatment According to 96 well Micro Pl
29. ming click Save as Standard Curve At the time window written Saved Successfully will pop up The current 96 well micro plate standard data can be saved as BMP images Notice The function is used for AL If standard curve of current 96 well micro plate data is comparatively good save it into standard bank As for the nest plate user only needs to make 2 point calibration BLIIf current standard curve is not so good invoke history record and save the standard curve in history record again I 13 3 View standard curve en HBcAb See picture 20 RLU Y 1 1000 R 1 000000 319 6 255 7 Picture 20 sis 127 9 64 0 View saved standard curve anc o OSE EH RSE T X 1 10 jroup of standard data 1 dot 0 50 17 1 33 7 50 2 66 8 834 100 0 with different fitting methods thus Ie ods One could find out the rule of standard point data by clicking Data View during analysis For example increasing and decreasing rules of the standard point concentration as well as the increasing and reducing rules of the standard point luminescence value 13 4 Compression and repair database In the time of Add the database or delete etc the database will have a lot of data redundancy Therefore 3D we can use this function to extend the database compression smal
30. mple or circle an area to place a batch of sample sharing the same type BOUse left button of the mouse to drag the samples or standards in Case Information to Layout Display Firstly click New Case Land input patient information Secondly select Patient Sample test date D a and reagent item in O and click Refresh Select a single sample a batch of samples in Case Information and drag it them to Layout Display Click Standard sample select Item Name and click Refresh in O Select a single standard sample a batch of standard samples in Case Information O with the left button of the mouse and then drag and drop it them in Layout Display CLiDouble click the right button of the mouse over Layout Display and set detailed information by Sample Edit Double click the right button of the mouse over Layout Display and a window will pop up See picture 20 Sample attribute Sample No S_41 Items T3 z l Case No 51_41 Name Type Gender M bi sus L Patient Birthday 2007 04 03 as O Standard Note a Control Remark x O Blank Picture 20 e e RLU oo o o Result Oe First select Sample Type and fill in the blank in the window with necessary sample information After confirmati
31. ncentration in patient s blood serum is clear Table of Contents Basic principle amp performance P 4 Standard operation rules 4 P 9 Uli Installation Guidance P 20 Shortcut User Manual P 21 Daily Operation Manual P23 Q Maintenance Manual eeeeeeeee P 39 Troubleshooting P 39 Guarantee Two year Free Maintenance The quality of the Chemiluminescence Immunoassay System is assured MS provides each customer a 2 year guarantee sheet of repair The guarantee is available given that the equipment has not been opened or repaired by technicians in other companies Basic Principle amp performance 10 Basic Principle 1 Purpose Chemiluminescence Immunoassay System is a kind of medical test equipment used for human immunoassay by testing human body fluid Chemiluminescence Immunoassay CLIA is high sensitive test technology applying for quantitative analysis of minim material in human body such as hypothyroid hormone gonad hormone 20 Basic Principle 2 1Reagents Characteristic Chemiluminescence is light emission induced by chemical reactions under normal temperatures Chemiluminescence is a multi step course The principle is as follows product molecules or intermediate molecules are activated to electric excited state by the energy produced in chemical reactions When th
32. ne status and coordinate location of layout area 3 8 Select Data Information Including Patient List Cases set by New Case Setting Standard ListU Information input by bar code Quality Control ListLi Data included in program Analysis Curve Display and Help System First select items in the menu then execute operation with the help of and 3 9 Filter cases or standards according to selected items and display the result in 3 10 Information List Information in the list can be dragged and dropped into Layout Display 2 Basic Operation 17 Sample Placement and Edit There are three methods for users to place sample in Layout Display Use and O to set sample informationBUUse left button of the mouse to drag the samples or standards in Case Information to Layout Display 0 C0Double click the right button of the mouse in Layout Display and set detailed information by Sample Edit AUShortcut tools Group samples information fast settings First select sample item in lock this item in O with the left or right button of the mouse and then left click the mouse over layout area to place a single sa
33. o ExamDate itemName ALU 2006 07 06 x Load Date PlateNo Jitem jaim 4 5 1 Open the window and select start date and end date Then you will see date record displayed at the 25 right bottom of the window Click any data record and a detailed list of the current test will be shown at the left part of the window OPlate No 0 is the ranking of 96 well micro plate of the daily test 5 2 History record management Right click the mouse over the target record to read or delete this record Notice Be careful that this operation is irreversible 61Save amp Read Plate Information iSee picture 5 I 6 1 SaveLWhen more than one 96 well micro plates information A r Delete needs to be input use this function to save them once according to the No of each plate Thus it is convenient to invoke needed plate information 6 2 Read According to saved plate No read information of the test plate 6 3 EditLiDelete unnecessary plate information 7UPint Setup iSee picture 6 x Mante Sub Title DOO O Default Report o y DefautRepoiFom 7 1 Main title and subhead of report should be set when installation is done Preset font in the computer is the same as that in printed report 7 2 Both single person report and report form is available 7 3 Click Save
34. on click OK to save it If any one of the certain patient samples is edited all the other samples will change consequently This is especially useful for a patient with many test items After test if obvious deviation in photon number or calculated concentration is found retest is recommended for those veterans they could correct the photon number by themselves Click OK to finish the photon number modification and begin to retest sample concentration Since the sample concentration is acquired through the photon analysis the method is only available for sample photon number modification and it cannot be used for modifying the sample concentration As for standard sample information input just select the bottle number of the standard sample and its corresponding concentration will be called up automatically by system given that the reagent bar code information has been correctly input into the system 2 Usage of Mouse at Layout Area See picture 21 23 Cut Copy Paste Clear all View Mode d Analy data Default Method 4 Parameter Raise 4 Parameter Decline Export Excel Save plate Cubic spline Load plate Semi log a Cl Picture 21 Beeline Right click the mouse over layout areaLand then a window See picture 21 will pop up The function of its menu in pop up window is the same as that of the same operation in LiMenu and O Tool Th
35. ontrol level inverter and data buffers Computer The computer controls the system Through special test software it controls equipment motion collects data processes data execute fitting calculation display test result and also print it etc Printer Print test report and data statistical report form 20 Technique Data Power Supply VoltageO220V 22V050Hz 1Hz Input AC Power 300VA Cross Talk Less than 1x10 Linearity range 502 000 000 RLU Repeatability CV lt 2 Stability CV lt 2 Sensitivity 100 RLU Accuracy 98 Test Time Less than 5 minutes 11s for sampling 96test samples Dimension 754mmx550mmx472mm IIM 644mmx440mmx278mm IM Computer Weight 25kg IIM 15kg IM Safety Type 1 B Fuse Type 2A 2 pieces 30 Operation Standard Quality System 0ISO13485 Enterprise Standard OYZB Min 0210112005 Production License Min Food and Drug Administration Permitted No 20050064 Registration Number Min Food and Drug Administration Permitted Year 2005 No 2400032 401 Operation Requirement 4 1 Ambient Condition X Ambient Temperature 15 0 35 Relative Humidity lt 85 at 25 Atmospheric Pressure 860hPal1060hPa Keep
36. ot be heard Solution 11 Turn off equipment and retest 2U1Open equipment and check whether magnet supply power of the optical fiber motion is 34 Fail to be protected from light Failure well connected Big error occurs when determining some low value or background noise exceeds 50 relative luminescence unit Solution 1 Check whether there is eyewinker at the door Communication failure Failure 2 3 Check whether the signal interface at the back of the equipment is well connected Check whether there is any crack in the equipment shell The equipment cannot connect to computer Solution 1 Check whether the communications setting is right 3 Mouse touch pad failure Failure 20 4 Solution Check whether the communication cable is well connected Check whether reset switch works Start equipment communication connection of the system self test program Mouse arrowhead is unable to move or move abnormally 1 Use a exterior mouse instead of the touch pad 2 If step 1 doesn t work open the equipment and remove mouse board connect wire No photon number in test result Failure All Solution the test data is ze
37. pounds consisting of antibody antigen and antibody HRP labeled antigen come into being on the surface of the micro plate After unbound antigen and HRP antigen are washed off by solution pre set chromogenic substrate solution is added to determine the relative luminescence intensity The more the free antigen in the sample the less the amount of conjugated HRP antigen According to the known concentration of the calibration materials and its related luminescence intensity dosage reaction curve is drawn and regression line is available after the fitting process Then the concentration of antigen present in the unknown sample can be calculated 2U Sandwich ELISA Solid Phase Chemiluminescence Enzyme Immunoassay taking micro plate as its carries follows the sandwich methodology The methodology uses 2 specific antibodies which recognize discrete sites on the unknown molecule The first antibody is precoated onto the wells of the micro plate It captures antigen in the blood serum after being added into the sample The other antibody connected with HRP is allowed to bind to the antigen Thus the immune compounds of antibody antigen labeled antibody come into being on the surface of the micro plate After unbound antigen and HRP antigen antibody are removed with a wash by solution chromogenic substrate solution is added to determine the relative luminescence intensity According to the relative luminescence intensity of th
38. range will be displayed at the right part of the window 12 3 Pallet come out Make pallet come out by hand When abnormal program termination or sudden power cut happens user should move 96 well micro plate pallet to the door by hand Notice There is an order while analyzing that is which one is to be analyzed first and which is the next While analyzing program will search whether there is standard material in the sample first If no standard 28 material is found it will execute analysis by directly using the standard in history standard bank if there has one it will judge whether the current standard is no less than 4 if it meets this requirement program will execute analysis by directly using current standard if it doesn t program will take out history standard and the current standard together to execute calculation and analyze it by 2 point calibration 13 Toolbar 13 1 Test item management Test item management includes three aspects Ultem information setting and analytical method choosing 0 O Reagent bar code input O Registration of opened reagent access Item information setting and analytical method choosing See picture 13 xl Reference range mm 9 9 PR LHL Unit E Gonad Coe z Picture 13 kanaan Z Usab Usetheltem Curve Cubic spine gt Oignaliem Adienere
39. ro or the data is invariable 1 Check equipment carefully in case there is serious light leakage Observe whether high voltage indicator light VH is lit during the test If VH is lit check Test result error Failure whether the high voltage interface is well connected If not check the high voltage control circuit Big error occurs that is low value cannot be determined or no photon number is shown when testing high value Solution 1 Start self test program use stable light source and reset equipment parameter 2 Start Comprehensive Test to check and adjust the equipment performance thoroughly Power shut down with trouble Failure Solution seriously influence the test result s accuracy 1 Start the parameter calibration use steady light source to newly set device parameter or derectly reduce the plus coefficient 2 Start Testing Tool Adjust and inspect device performance across the board 35 36
40. s standard point at the right part of the window Close the window 4 3 Optimize the system based on the test item use frequency It is not convenient if all the test items are default since there are many saved ones But users themselves could set the items with high use frequency as default Set default Tooll Item and data setting N Test Item Management Use this item 5 Calibration 5 1 Check the saved standard curve Use 6 point calibration for items without standard curve 5 2 Check reagents lot number Use 6 point calibration for reagents with different lot number 5 3 Use 2 point calibration for those have standard curves and those share the same lot number 5 4 Standard sample calibration Standard sample should use the same 96 well micro plate as the test sample and should be determined together with the test sample 6 Quality Control 6 1 Quality control material For qualitative analysis there is negative material and material For quantitative determination there is low medium and high material 6 2 Test for quality control material Use the same test method as the test sample 6 3 Quality control result positive The quality control level must be within stipulated range Within 2SD range according to reagents explanation or
41. st Result to EXCEL See picture9 D arh opur udannadean Ean r Ex trem xl a XFA r x 1 ienn gt Otta EJE R 2p scat aL _ Picture 9 Export Function same with current data expot function only different is it can export by bath Operation_First choose the exported date limit and select the location and name of the exported file by clicking Browse Second click search and system will list test record and standard data which meet the above set requirement Export one item or export all the item is determined by choosing Test Data or Standard Data Then click Export The export of history data is done 10_JEdit_See picture10 10 1 Cut Select plate information and click Cut Thus this item is saved into Cut Ctrl x system cache and the current selected sample is Copy Ctrl C deleted as well Paste Ctrl V Delete 27 Clear all Picture 10 10 2 CopyliSave selected item into system cache 10 3 Paste Paste data in program cache to designated place 10 4 DeleteDelete all the current selected sample 10 5 Clear All Clear all the sample information in the current layout area Be careful Notice Both single sample operation and multi sample operation are available When copying and pasting sample in specific area layout form of the copied sample is saved
42. ts lotion substrate solution To provide a perfect uniform reaction environment as well as to ensure the test result s accuracy please only use the diluents lotion and substrate solution that are exactly matched with each reagent box 4 Operation Condition Ambient Temperature 150135 Relative Humiditys85 at 25 Power Supply 1220V 22V050Hz 1Hz or 110V 11VU60Hz 1Hz 5 Equipment Standard Operation Rules 1 Preparation before running the equipment 1 1 Check whether the power supply is connected 1 2 Check whether the environment temperature meets the requirement 1 3 Check whether the printer is connected 1 4 Check whether there is a 96 well micro plate that has been used before inside the equipment If there is one please take it out 1 5 Make sure the equipment door is closed 2 Start the equipment 1 1 Start the printer 1 2 Start the computer the parting instrument starting operation refer to computer user manual 1 3 The equipment practice automatic check for both software and hardware system 1 4 When check finishes Connoted with equipment is displayed at the bottom left of the screen The system is ready 3 Reagent preparation and check 3 1 Take reagents out from refrigerator 3 2 Check whether all the reagents and quality control materials are under the period
43. turn from A1 to H1 A2 Sample layout According to 196 well Micro Plate Layout Information drag the sample items in the new case one by one or the whole items with mouse and drop them into the 96 well micro plate area at the left part of window Save layout information Method 1 0OFile Save Method 2 Right click the mouse over the layout area Save 7 2 About patient sample Put reagents or sample into corresponding reaction wells in turn Implement incubation micro plate wash and luminescence reaction 7 3 Run test Place 96 well micro plate into the equipment OPay attention to its posting direction Recheck 196 well Micro Plate Layout Information Owith 96 well micro plate layout in program window Click RunO or OTesto ORun 0 to start test Picture for your reference Check sample statistical information in the pop up window Make sure there is no error in the statistical information ClickOStart Wait till it finishes 7 4 Check test result Check basic information U View1 Layout Information Check sample photon number Viewi U Photon Number Check test result Viewi UTest Result
44. yzer before shipping the step is for renew installing 2 1 Start computer and enter Windows 98 Windows2000 or Windows XP 2 2 Run FreeCLiA exe in disk that follow with device 2 3 The software will be installed in_D FreeCLlA as default Or user can change the installation directory 2 4 Installation program will set up shortcut on the desktop of Windows 98 2000 XP and in program file respectively 3 Program Function Double click icon FreeCLiA and start the software Then Login GUI will show up 20 See picture ng Picture1 Input User s Name The User Name here is only for login Then enter main interface directly See picture 20 3 1 Menu File Menu Edit Menu View Menu Project Menu Tool menu 3 2 Frequently Used Tools B 2 gt E amp a T New Case Open ReSave Run Analyse Preview Eject Setup gq 3 3 Frequently Used Tolls on panel Dba Pst Por bac Poe E eens 3 3 4 Test Item Setting Use command in and O to fix sample type 3 5 Layout Display Display 96 well Micro Plate in manner of 12x8 matrix 3 6 Basic Sample Information Show basic information of the sample selected by mouse 3 7 Status Column Display onli

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