Automated Chemistry Analyzer CliChem 120 User's Manual
Contents
1. When the machine is conducting tests normally any operation in the working area of the machine is prohibited so as to prevent moving parts from injuring the operator To replace the bulb switch off the machine and wait half an hour to prevent heating components from scalding the operator If any accident occurs when the machine is running such as probe collision abnormal noise of the rabble or motor or peculiar smell switch off the power immediately Contact the customer service staff for treatment In case of fire use powder fire extinguisher to put out the fire 80 Appendix A Test Methods A 1 End Point Method When the tested substance is fully converted to a product after a certain time in the reaction the absorbance of the reaction liquid will not be increased or decreased any longer and the end point is reached the concentration of the tested substance is obtained according to the end point absorbance this is the End Point Method Absorbance Time Delay Time L Measurement f Time End Point Method A 2 Two Point Method Two Point Method In a certain reaction time the reaction rate is in proportion to the concentrations of reactants As the reactants are being consumed continuously the reaction rate is reduced continuously which is reflected by the increasing or decreasing absorbance and the reducing rate Measurement must be conducted in the certain time period In the time period the increa2. 88 9 19 29 39 49 59 69 79 89 10 000000000 Replace Cuvettes Check Blank Print Explorer Touch Screen System Setup Cancel Figure 11 5 Maintenance Cuvette Blank Replace Cuvette When Replace Cuvette is pressed the system will turn the 9 fold of cuvettes to the Manual Replacement window in turn and prompt you for replacement Press the Stop key to stop the replacement of the remaining cuvettes Cuvette Blank Detection When the Cuvette Blank Detection key is pressed the system will detect the cuvette blanks for various wavelengths of 90 cuvettes automatically and then display the cuvette blank value corresponding to the specified wavelength automatically Blank Screening Set the screening range of the cuvette blank corresponding to the specified wavelength and press the Refresh key The system will judge the validity of each fold of cuvette blank according to the range set and indicate it with a color Print Press the Print key to print the cuvette blank values displayed in the list 75 Backup Service Log Debug Blank zi m ke D o KI o 3 CH EZ bh a o Standard Parameters Blank Range 65553 1 E 340 2 a 4 5 6 670 a 760 ig Read Update Read Update Explorer Touch Screen System Setup Cancel Figure 11 6 Maintenance Configuration Restriction Parameter The blank range is the criterion for judging whether the assay cup can be used Wh
3. 1 3 EU MT RE 10 1 2 Composition and Structure of the Instrument 10 1 2 1 Structure Duagram EE 10 1 2 2 Right Side Sta e t e ctr eet qut E eee need 11 1 2 3 Rear Side BEI CUR 11 2 A e o O a E A E 12 p E f 12 LS e KENE EE 12 CHAPTER 2 INSTALLATION AND CORRECTION eee 14 PAM caa 14 EX el Beie E 14 2 1 2 Handling Method nS EIER RBRUM ee LO SERPENS ERR SIN os 14 2 2 Installation and Use Environment cccccsseecceeeecceeeecceueeeceececsaeeesseeeeeseeeessaees 14 2 3 Requirement OF Power Supply ie 15 ZA MSM inmates E E T E E A 15 2 5 Correction EE 16 CHAPITER S SIDA W 17 3 1 Precautions before Starting the Machine 00 0ccnecseiesecesadsnecenestnasssetanncenecencnasens 17 3 2 Logging on to the System euiugagggegegeegte ege dEEgEEREE NAM XDAVAN MASS DAE 17 3 3 Maln SCTE OR sessionen a a a a e eae Uu ou 18 A A basil sicesetiiesiuacewib vices 19 CHAFIER AITEM SETUP EE 21 4 1 Item Parameter Saad 21 4 2 Item Test Methods egene inb Yerba bu ai 30 CHAPTER 5 3010 RT KE 32 A eo E A 32 a e 0 a a i 33 maler aos 34 SAPON o 35 5 3 Reagent A a adu tached lad deadenisiceaiuncienaddhrseisucnes deacuuetied 36 SEENEN 37 USA 38 LHAPIER S TSE AA A a 40 6 1 Sample EOY E 40 GA Sample Dhaka eege dee r R ERATE RRR ER RE NE 40 6 1 2 QC Substance Application oooooccnnoccnoncccooonononononon
4. and confirm the test contents applied for in the worksheet Caution When all sample applications are finished click List for verification and confirmation to avoid mistake or omission Delete Sample Select a sample from the list and press the Delete key to delete the selected application press the Delete AII key to delete all applied samples 6 2 Sample Test Function Brief To start the applied test and view the test status and results On the main screen or Sample Entry screen press the Test Status key to enter the screen as shown in the figure 44 Remaining time Q SEH Reagent Cuvette Result Information Routine Dilution Stat Testing Control Finished 50000 Standard Waste Empty Empty Unknown O Untested O Testing O Completed O Abnormal 900 Ge 9 oe o Error Start Pause Stop Curve Hetest Replace cuvettes Statistics Print Cancel Figure 6 6 Test Status Press the Start key and the prompt box as shown in the figure will appear Confira Normal Rerun FT Clear all results Figure 6 7 Worksheet Confirmation Initial Test To conduct initial test for the tests not finished or retests in the current worksheet Retest To conduct retest for the results exceeding the linear range of the finished tests in the current worksheet Clear Test Results 45 To clear the results of the finished tests in the current worksheet and restart all tes
5. conducted by sample QC and standard The statistical results include total finished average standard deviation and coefficient of variation and can be printed e Print Print the results of finished patient sample tests AU Indication The symbols A lt and A gt indicate the test results exceed the linear range The symbol indicates the results of the retest still exceed the linear range Status Ready indicates the test is going to begin Test indicates the test is being conducted Finished indicates the test has been finished Test Fails indicates reagent sample addition failure i e collision or reagent sample lack during a test Test Given Up indicates the item for which the test has not been finished or started is aborted Unit SE indicates substrate exhaust OL indicates the results exceed the linear range Select the Results page on the Test Status screen to view the test results meeting the specified criteria through the list Toa TO Remaining time O q statistics Figure 6 16 Test Status Message SE Number of Tests Prompt of the total number of tests included in the Current Worksheet Remaining Time Prompt of the remaining time for finishing the tests in the Current Worksheet Prompt Message Displays the prompt messages during the tests in the worksheet including start time end time reagent sample lack etc Press the Clear
6. new password again for confirmation and press the Modify Password key 39 Chapter 6 Test 6 1 Sample Entry Function Brief To set test application Click Sample Entry on the main menu to enter the Sample Application screen as shown in the figure Position 11 ei Smalltube e Routine C Stat Control C Calibration Sample No n 20824001 Sample type Serum Repeat E D Dilution ratio None ge Save Batch Save Delete Delete All List Status Cancel Figure 6 1 Sample Entry 6 1 1 Sample Application Edit a Sample Step 1 Select Sample Position If micro sample cup is adopted select Micro Cup Step 2 Select the sample type Regular or Emergency Treatment Step 3 Input the sample number and specify the sample type Step 4 Select the repeat count and dilution ratio default repeat count 1 default dilution ratio Not Dilute Step 5 Select test items and test combinations Step 6 Press the Save key Step 7 Finish a sample application Edit Multiple Samples Step 1 Input the start sample number and specify the sample type Step 2 Select the repeat count and dilution ratio default repeat count 1 default dilution ratio 40 Not Dilute Step 3 Select test items and test combinations Step 4 Press the Batch Save key and the screen as shown in the figure will appear Batch Save Figure 6 2 Batch Save Step 5 Input the start sample position and end sample position and pre
7. reagent kit used The unit is 1 10000 absorbance The setting 0 indicates no judgment Test Sequence Setup Press the Test Sequence key to enter the screen as shown in the figure 2074 Figure 4 7 Test Sequence Setup The function is used to set the test priority of items Select the item for which the test sequence needs to be set use the Up and Down keys or mouse to adjust it to the proper position and press the Save key after adjusting all items To restore the default test sequence press the Restore key and save the setting Caution The default test sequence is in alphabetical order of item names Combination Setup Press the Combination Setup key to enter the screen as shown in the figure 28 Figure 4 8 Combination Setup Add Combination Press the Add Combination key input the name of the new combination and press the OK key Select the items to be included in the combination and press the Save key Modify Combination Select the combination to be modified from the combination list modify the items included in the combination and press the Save key Delete Combination Select the combination to be deleted from the combination list and press the Delete Combination key 4 1 2 Non biochemical Items To input the results of non biochemical items tested by other equipment to the system set the parameters of the non biochemical items to be input Select the Non biochemical Items page as shown in the fi
8. the rear panel Add a proper amount of purified water to the cleaning solution bottle Put the waste liquid bottle on the ground so that the waste discharge system can work normally Turn on the power switch of the machine and start the control software To switch off the machine turn off the applications and then turn off the power switch 15 2 5 Correction Standard substances can be used to correct the instrument The instrument needs not to be corrected for each test However for items requiring calibration regular calibration tests are needed The changes in the system environment may impact the tests to a certain extent so a calibration test is suggested each time the machine is switched on to ensure the accuracy of test results After each calibration QC substance must be used to verify the accuracy of the machine For the calibration and QC test methods refer to Daily Tests 16 Chapter 3 Start 3 1 Precautions before Starting the Machine Before you start the machine each time pay attention to the following to ensure the system is ready 1 Check the status of the instrument Check that the mainframe has no obvious physical damage there is no dust or liquid accumulated on the surface of the workbench the pipes printer etc are properly connected 2 The power supply is properly connected with good grounding 3 Check whether the paper for the internal or external printer is adequate and whether it is insta
9. the test records meeting the specified criteria Click Print Report Historical Records on the main menu to enter the Historical Records Inquiry page as shown in the figure 65 Date SampleNo Test Quali Quan Resut Unit gt 2012 07 01 120701001 ALBI Quan 3 405 gil 2012 07 01 120701001 ALB2 Quan 5059 706 g l 3 2012 07 01 120701001 ALTI Quan 41 216 g l 3 2012 07 01 120701001 AT Quan ERR ai 2012 07 01 120701001 B1 Quan 0 555 gil 2012 07 01 120701001 B2 Quan 27 333 gil 2012 07 01 120701001 C1 Quan 0 848 gil 2012 07 01 120701001 C2 Quan 11 634 gil 2012 07 01 120701001 CHO Quan ERR gil 2012 07 01 120701001 CHO2 Quan 4 593 ai 2012 07 01 120701001 CREI Quan 1 615 gil 2012 07 01 120701001 een Quan 8 526 gil 2012 07 01 120701001 oer Quan 93 586 gil 2012 07 01 120701001 GLUI Quan 0 372 gil 2012 07 01 120701001 GLU 2 Quan 30 712 gil 2012 07 01 120701001 TPI Quan 265 184 ai v iul CR Select All ES Search Delete Print Curve D l Cancel Figure 9 6 Test Records Inquire Test Records Press the Inquire key and the screen as shown in the figure will appear Query conditions of test record Test Sample No Iv Date from 2012 08 24 To 2012 08 24 E OK Cancel Figure 9 7 Test Records Inquiry Criteria Input the inquiry criteria and press the OK key The list will display all test records meeting the criter
10. 0 360 C Mean 4 737 SD 0 261 CV 5 596 Cancel Figure 7 4 QC Chart The screen displays the target value and SD value of the QC item as well as the statistical results of the selected data average SD and CV The system can change the QC chart according to the drawing mode specified by you Press the Print key to print the QC chart displayed on the graphical screen Real Time QC Chart Drawing all data with each QC datum corresponding to different abscissas on the chart Daily QC Chart Calculating the average of the data in the same day and drawing the points corresponding to the average of each day only with the average of each day corresponding to different abscissa Cumulative Chart Drawing all data with the data in the same day corresponding to the same abscissa Delete QC Data Select the QC data to be deleted from the QC data list and press the Delete key Print QC Data Select the QC data to be printed from the QC data list and press the Print key zs Chapter 8 Calibration 8 1 Standard Setup Press the Standard Setup key on the main screen to enter the screen as shown in the figure Test Ref value Unit A Calibration No Batch No Hap 3 gll ALB2 13 gll ALTI 0 24 gll ALT2 0 73 gil cHO1 3 906 g l z _ cHo2 0 36 gil CRE1 0 58 gil CRE2 3 gll GGr1 0 48 gil d Jeer 2 gil GLu1 0 5 g l GLu2 2 gll TP1 5 gil TP2 8 gil UREA1 0 gil UREA
11. 2 08 24 to 2012 08 24 ee Ok Cancel Figure 9 2 Patient Records Inquiry Criteria Input the inquiry criteria and press the OK key and the list will display all patient records meeting the criteria Caution The patient results exceeding the reference range are presented with red background After the retest for the patient results the results of the current and preveious tests are displayed in the Results and History fields respectively Edit Patient Information Select a patient from the list and press the Edit key to enter the screen as shown in the figure 62 Patient information Test Result Sample No Profile ai X ies Resun Junt Remark Wa Name HUIYREI JALTI 999999 g l 41 25 ALT2 120 533 gll Clinic No 568 CHO1 999999 g l 9999t Jeen 14019 gll 14 84 BedNo 25468 Jeer 63 407 gll 4 691 Jeu 2 138 gil 2 1 ar vear Jeus 9 157 gil x 37 79 id Gel Meng TP 9 31 gil 5 177 ee a TP2 31 38 gil UREA2 6 847 gil 78 B B1 0 599 gil 0 513 Department Die z Je 999999 oi 9999 cz 13 219 gl Sentby RKGPOER Sr m Note ERGJKERG D Test si Result New Save E Save Delete Cancel Figure 9 3 Edit Patient Add Patient Records Press the Add key input the basic information of the patient in the left list and press the Save key Edit Basic Information of Patient Edit the information in the left list as needed a
12. 2 3 gll v ein N New Delete Cancel Figure 8 1 Standard Setup Add Standard Press the Add Standard key input the number and batch number on the screen that appears and select OK to save the setting Add the calibration items included for the standard substance in turn Delete Standard Select the standard substance to be deleted from the standard substance list and press the Delete Standard key Add or Modify Calibration Item Specify a standard substance and press the Add Item key Select Add or the calibration item to be modified on the screen that appears input the reference value and press the Save key Delete Calibration Item Select a standard substance from the standard list and the calibration items included will be displayed on the left list Select the calibration item to be deleted and press the Delete Item key 58 Caution When an existing standard substance is deleted the calibration results corresponding to the standard substance will also be deleted When an existing calibration item is modified or deleted the calibration results corresponding to the calibration item will also be deleted 8 2 Standard Application See 6 1 3 Standard Substance Application 8 3 Standard Inquiry Function Brief To inquire the calibration results of the specified item Select the Standard Inquiry page as shown in the figure ALB Calibration Curve One point linear 4 0 0 0454 0908 1361 1815 2269 2723 31
13. 76 363 g L Hz 3 63 204 K 56 198 Delete Print Cancel Figure 8 2 Standard Inquiry View Calibration Results The left list displays all items with calibration test finished Click an item and the corresponding calibration data and standard curve will be displayed on the right automatically Delete Calibration Results Select the calibration results to be deleted from the calibration data list and press the Delete key 59 Print Calibration Results Select the item for which you want to print calibration results from the left list and press the Print key 60 Chapter 9 Report Printing 9 1 Patient Records Inquiry Function Brief To inquire patient records meeting the specified criteria You can edit and view the basic information and test results of the selected patient one by one Click Print Report Patient Report on the main screen to enter the Patient Records Inquiry page as shown in the figure Sample No Mee ClinicNo BedNo Name Sex Age H B E E lt i Gi KI Select All E Profile AN D gent Delete Print Send Calculate Check Setup Cancel Figure 9 1 Patient Records Inquire Patient Records Press the Inquire key and the screen as shown in Figure 9 2 will appear 261 Query conditions of patient s record Sample No fo Clinic No Bed No fan Name Department Py Sent by Tested by Checked by Note Date from 291
14. Automated Chemistry Analyzer CliChem 120 User s Manual BGT BioGenTechnologies BGT BioGenTechnologies GmbH Von Langen Weg 10 D 48565 Steinfurt Tel 02551 4090 Fax 02551 1298 Web www biogentechnologies de E Mail info biogentechnologies de Rev 1 0 How to use the Manual Thank you for using CliChem 120 Automated Chemistry Analyzer Before operating the instrument be sure to read the Manual carefully To get the best results you must be aware of our instrument and its performance before clinical diagnosis and testing This is the User s Manual for BGT CliChem 120 Automated Chemistry Analyzer It describes the installation daily use and maintenance etc of the instrument After reading the Manual please keep it properly for future reference The functions may vary depending on the version or configuration of the instrument Please keep all packing materials for future storage transportation or return to the manufacturer for repair If you have any questions contact your dealer Meaning of Symbols Warning Indicates when the user ignores this symbol and misuses the instrument casualties serious injury or serious property loss may be caused to the user Caution Indicates when the user ignores this symbol and misuses the instrument injury wrong output results or property loss may be caused to the user Precautions for Diagnosis Caution The product is a clinical examination instrument for inspection Clini
15. Reagent Positions Sample Positions Light Source End point method two point method rate method etc Factor method single point calibration multi point calibration linear regression nonlinear regression etc 8 opticalfilters 340 405 450 510 546 578 630 and 670 nm 26 positions 9 positions 12 V 20 W long life halogen lamp 12 Stray Light Display Printing Working Condition Storage Condition Working Power Power Fuse Protector Absorbance gt 2 3A LCD Internal printer external printer optional 20 C 30 C RH40 80 no condensation Atmospheric Pressure 86kPa 106kPa 0 C 40 C RH lt 93 indoor environment without corrosive gas and with good ventilation a c 110V 220V 50Hz 60Hz 1500VA T5 0AL 250V 5x20 13 Chapter 2 Installation and Correction 2 1 Unpacking 2 1 1 Steps of Unpacking Unpack the instrument and remove the materials for transport Keep the packing case and packing materials properly for future repacking 1 Putthe wooden case cover on the level ground horizontally Use the screwdriver and pliers to open the metal latch around the wooden case Be careful in operation and prevent the sheet metal from cutting hand 2 Take out the accessories and check the objects against the accessories list If any object is missed immediately inform BGT s after service department or retailer Check the contents in the packing case and check that the f
16. a Reac Method Wavelength nm Method End point D WI 405 D Blank No Y WL2 No Test time 30 H 60 Sec Calculation method Correction factor Calculation Factor D K n 1000 B 0 Volume setup Ref Range Limited Range El Delete Print Profile setup Test Sequence Cancel Figure 4 1 Item Setup Add Item Press the new key and input the name of the item to be added Input the various parameters of the item to be added in turn and press the Save key Modify Item Select the item to be modified from the list and the corresponding parameters will appear on the right Move the cursor to the information to be modified in turn and press the Save key Delete Item Select the item to be deleted from the list and press the Delete key Print Item Parameters Select the item to be printed from the list and press the Print key 21 Item Parameters Description 1 2 3 4 Full Name Input the full name or description information of the item Unit Input or select the unit of the test results of the item Decimal Point Select the number of digits after the decimal point of the item results on the general report to be printed with a maximum of 3 digits after the decimal point Indirect Calculation If the results of the item can be obtained through the calculation of other items select Indirect Calculation and press the Calculation Formula button to enter the screen as shown in the figure Formula Cal
17. ample Volume for Retest Reagent Volume The accuracy of reagent volume is 1 uL Input the volume of reagent 1 If the dual reagent test is adopted also select Reagent 2 and input the volume of reagent 2 Caution If the dilution ratio is specified for the samples of a patient the samples of the patient are prediluted before test according to the dilution ratio set Otherwise the dilution ratio specified in the item setup parameters is used Caution Only when the test results exceed the linear range of the instrument and automatic retest or manual retest is conducted will the dosage set in Retest be used Otherwise the dosage set in Initial Test is used 12 Reference Range Specify the division criterion of the reference range and the corresponding values of reference range according to the instructions of the reagent as shown in the figure 25 Figure 4 5 Reference Range 13 Limitative Range Limited Range CH Linear range Reagent blank Linear limit Substrate exhaust E Save Cancel Figure 4 6 Limitative Range Linear Range Test range of the instrument or reagent When the test results exceed the range the results are unreliable and retest after dilution or retest after concentration is needed Reagent Blank The valid range of reagent blank When the reagent blank exceeds the range the system will treat the reagent as failure The unit is 1 10000 absorb
18. ance Linearity Limit Effective for the rate method only The system calculates the linearity in the test period automatically When the linearity reflecting the curve exceeds the set 26 range the results will have the corresponding sign The setup range of linearity limit is 0 300 The setting 0 indicates no judgment The default is 20 The calculation formula of linearity limit is Number of test points gt 9 Linearity Change rate of the first 6 points Change rate of the last 6 points Change rate of all points 4 lt Number of test points lt 8 Linearity Change rate of the first 3 points Change rate of the last 3 points Change rate of all points Substrate Exhaust Limit Effective for the two point method and rate method only Some high concentration active samples exhaust the substrate which makes the reaction no longer a kinetic method reaction In order to correctly reflect the determination results the substrate exhaust limit a certain absorbance needs to be set which should be exactly the critical point between linear zone and nonlinear zone kinetic method or 1 level reaction zone and multi level reaction zone fixed time method in the reaction curve the minimum the reaction curve bends downward or maximum the reaction curve bends upward absorbance value before the substrate is exhausted within the reaction time The substrate exhaust limit of an item is closely related to the
19. arameters Read system parameters from the middle computer System reset Conduct whole machine reset and hydraulic circuit perfusion to prepare for testing Replacing cuvettes Replace 1 9 fold of cuvettes in turn Each time a fold is replaced press the OK key To skip the replacement click the Stop key quickly and select Yes from the pop up box 3 3 Main Screen After cuvette replacement the system will enter the main screen Here Waiting for stable light source is displayed on the top of the screen The test can be commenced only when the light source becomes stable and Ready is displayed on the upper part of the screen as shown in the figure 18 37 Lamp Stabilizing Admin 2012 08 23 16 46 05 Help Request Parameter Ej Status Ih Cal Setup im BioGenTechnologies Results Bio Setup l Auto Chemistry Analyzer 1 Q Calibration s Setup EZ Control y Maintenance anh Jh A A Detail Exit Figure 3 3 Main Menu Caution Each time the power is switched on it takes 30 minutes for the light source to become stable If the test is commenced before the light source becomes stable the accuracy of the results may be affected 3 4 Function Modules The main screen contains 10 function modules 1 Sample Entry Used to apply for test samples including regular samples emergency treatment samples QC substances and standard substances 2 Test Status Used to view t
20. cal diagnosis based on testing results should be conducted by doctors according to the clinical symptoms of the patients by combining other inspection results Representation BGT reserves the right for the final explanation of the User s Manual The illustrations in the Manual give typical examples only and may not be completely consistent with the actual displaying on the product Take practicality as standard Never use the illustrations for other purposes Without written consent of BGT no individual or organization may duplicate modify or translate the contents of the Manual BGT will be responsible for the safety reliability and performance of the product only when all the following requirements are met Assembly re debugging expansion improvement and repair should be conducted by persons recognized by BGT e The product is operated according to the Manual e The related electrical equipment complies with the national standards Caution e The instrument must be used by medical examination professionals or trained doctors nurses or 22 laboratory technicians Warning e If no satisfied maintenance repair plan is achieved the instrument may fail abnormally and may endanger personal health e Ensure to use the instrument in the conditions specified in the Manual Otherwise it may cause the instrument s failure to function normally and unreliable measurement results damage the components of the instrument and
21. can press the Pause or Stop key at any time The test results will be saved to the worksheet and historical records automatically You can view 30 the test results and reaction curves at any time The test methods include end point method two point method and rate method For details see the appendix The calculation methods include factor method single point calibration multi point straight line calibration multi point fold line calibration double logarithmic curve calibration parabola calibration exponential curve calibration and Logistic Log 4P For details see the appendix 234 Chapter 5 System Setup On the main screen click System Setup to enter the screen as shown in the figure System Setup Reagent Department User Setup Cancel Figure 5 1 System Setup 5 1 System Parameters Functions Brief Including automatic retest switch automatic transmission switch and reaction tray temperature setup From the System Setup menu select System Parameters to enter the screen as shown in the figure 32 Control switch l Linearity range exceeded auto rerun A TUE PUDUKCU TU TR EIE TUUM TUTO TUR A nit iunc a a Temperature Ambient 30C 37C Report setup Unit setup Port setup Save Cancel Figure 5 2 System Parameters Setup Control Switch Setup If option is selected and the test results exceed the linear range when the initial test is finished retest will be conduc
22. culation test ci Formula The formula can only contain t LL The input format of the test is test name The format of the calculation formula is as follows TP ALB E Save Cancel Figure 4 2 Indirect Calculation Setup Input a calculation formula in the Calculation Formula input box If GLB can be calculated through the difference between TP and ALB input TPj ALBj in the calculation formula for the GLB item Caution A calculation formula is composed of G digits and Item Name only Otherwise the formula is regarded as invalid 5 6 7 Wavelength Wavelength set according to the instructions of the reagent If the single wavelength test is adopted set wavelength 1 only and select None for wavelength 2 However in order to eliminate external interference it is suggested to use the dual wavelength test Test Method Select End Point Method Two Point Method or Rate Method Blank Test Select None Reagent Blank Sample Blank or Pre sample Blank None The blank value needs not to be reduced Reagent Blank The reagent and sample volumes for normal tests are used and the sample is substituted with distilled water or saline Sample Blank The reagent and sample volumes for normal tests are used and the reagent is substituted with distilled water Pre sample Blank The blank value after the reagent 1 and sample are mixed should be 222 5 reduced Caution With th
23. curacy of system tests may be affected 11 2 3 Maintenance and Upkeep for Long term Out of Use Before long term out of use of the machine keep the washing bottle empty and run Hydraulic Circuit Perfusion in running maintenance to completely drain the liquid from the hydraulic circuit Take out all test cups in the reaction positions and empty the residual cups on the reagent tray and sample tray Wipe the surface of the workbench clean with cotton ball UP Chapter 12 System Failure and Treatment This chapter describes the common faults and trouble shooting of the instrument If the trouble can t be cleared after the tips in this chapter have been followed or you need more details contact BGT s Customer Service Department Fault Solution The software can t run normally Check whether the mainframe of the analyzer has been turned on Check whether the control serial port cable is connected to the control computer and analyzer correctly Check whether the control computer uses the port specified by the system software The cuvette blank is invalid Check whether a clean cuvette 1s replaced Check whether the cuvette is stained Check whether the light source energy is normal Whether the cuvette blank range is set correctly Whether the gain coefficients corresponding to various wavelengths are reasonable The volume of liquid filled is Check whether the sampling pipeline is properly clo
24. ding to the various wavelengths The cuvette blank threshold is used to set the cuvette blank warning limit When the cuvette blank exceeds the range set the cuvette blank will be regarded as invalid and will not be used The optical filter configuration parameter is used to record the wavelengths corresponding to the various filters configured in the system In order to prevent the configuration parameters from being damaged or lost which causes the equipment to fail to function correctly please make backup of the configuration parameters in the normal mode so that the configuration parameters can be restored by using the Restore function when necessary Backup and Restoration of Database The database is data files used to store setup parameters and historical test results Make backup of the database regularly so that the database can be restored in case data are damaged or lost Data Purging Used to purge data of specified types in the database Data types can be selected according to the actual needs Once purged data can t be restored Historical Data Test results and basic information of patients QC Data Results of QC tests Calibration Data Results of calibration tests Setup Parameters Item setup parameters standard setup parameters QC setup parameters combination setup parameters calculation item setup parameters non biochemical item setup parameters reagent setup parameters system setup pa
25. e end point method the absorbance value of the reagent blank test is reduced with the two point method and rate method the variation per minute of the reagent blank test is reduced Caution Pre sample Blank can be selected only when the dual reagent end point method is used to test items 8 Measurement Time To set the start time ane end time of measurement respectively For single reagent items the range of measurement time is 30 600 seconds for dual reagent Items 30 300 seconds Caution With the end point method usually only one measurement point is specified if more than one measurement point is specified the average of the points is taken as the calculation value With the two point method the measurement time should not be less than 30 seconds With the rate method in order to ensure the accuracy of the test results it is suggested that the measurement time be greater than 90 seconds For the two point method and rate method set measurement time as long as possible 9 Calculation Method Select the corresponding calculation method according to the actual needs When the Factor Method is selected you can input factor values manually Caution The signs of the factors of items tested with the rate method reflect the change directions of the curve If it is downward reaction the factor is negative otherwise the factor is positive 10 Correction Factor Linear correction factor of system test results Result Measurem
26. e sample type QC Step 3 Select the QC substance number and the QC items included in the QC substance will be displayed in the list below Step 4 Select the repeat count Step 5 Select the QC items from the list Step 6 Press the Save key Step 7 Finish the QC substance application 6 1 3 Standard Substance Application The Standard Substance Application screen is as shown in the figure 42 Position E D F Smalltube Routine C Stat C Control Calibration Standard No vz z Repeat 1 D Batch Save Delete Delete All List Status Cancel Figure 6 4 Standard Substance Application ze Save Step 1 Select Sample Position If micro sample cup is adopted select Micro Cup Step2 Select the sample type Standard Step 3 Select the standard substance number and the calibration items included in the standard substance will be displayed in the list below Step 4 Select the repeat count Step 5 Select the calibration items from the list Step 6 Press the Save key Step 7 Finish the standard substance application List Click the List key to enter the screen as shown in the figure 43 Test list Position Small tube Sample No Test Profie Test ype Sam H 120824001 ALB ALT CFProfilel Routine gt Delete Delete An Cancel Figure 6 5 List The list displays all sample tests QC tests and calibration tests applied for in the worksheet The list is used to check
27. eaction curve view Select the Results page on the Test Status screen to view the test results meeting the specified criteria through the list in the list the red background of test records indicate Normal the green background indicates Finished and the white background indicates Unfinished Total ban Remaining time Q E Status Reagent Cuvette Result Information Position Ai D Category Ai D Total 180Test 1 120702001 20 943 gL 1 120702001 1 120702001 Lack sample 1 120702001 Lack sample 1 120702001 Lack sample 1 120702001 Lack sample Start Pause Stop Curve Retest Replace cuvettes Statistics Print Cancel Figure 6 15 Test Status Results e Display Type Specify the sample position and type and the system will screen the test records according to the requirement automatically Reaction Curve Select a test from the list and press the Reaction Curve key to view the reaction curve corresponding to the test the reaction curve can be viewed only when the test is finished otherwise the system prompts a message The reaction curve does not exist Retest Select the results for which retest is needed from the list and press Retest to mark the selected records with Retest If the system is running a test a test marked with Retest will be added automatically otherwise the system will run retest in the next test Statistics Statistics of items in the results list can be
28. en the blank of the assay cup is within the range it is judged as Valid otherwise it is judged as Invalid The sytem will skip invalid assay cups automatically Press the Read Parameter key to get the current blank restriction parameter of the system Input the blank range and press the Update Parameter key to save the setting Caution The blank range must be obtained through actual tests If the range is unreasonable the system can t conduct the test normally When different batches of assay cups are replaced enter the Cuvette Blank page to conduct the test and view the cuvette blank range of the batch and then set appropriate restriction parameters according to the test results of various wavelengths Optical Filter Parameter Wavelength displays the wavelengths corresponding to the 8 optical filters of the system in turn The Gain column displays the gain coefficients corresponding to the 8 wavelengths in turn When the gain coefficient corresponding to a wavelength needs to be adjusted you may modify it manually or press Automatic Gain Configuration to get the appropriate gain coefficients and press Update Parameter to save the parameter obtained When the cuvette blank energy of a wavelength is on the low side the corresponding gain coefficient should be increased Otherwise 76 the gain coefficient should be decreased Caution Common users must not modify the parameters on the Configuration page otherwise the ac
29. endanger personal safety Major Icons Used in the Instrument Temperature Limit The temperature limit of the transport package Fragile Objects The transport package contains fragile objects Be careful in handling Upward The correct position of the transport package is straight up Ce a a Prevent Rain Protect the transport package against rain Layers Limit The maximum number of layers stacked for the same kind of package N indicates the layers limit REI A L E Prevent Sunshine Avoid direct sunshine EN gt Do Not Roll Do not roll the transport package 4 E 4 Biological pollution Caution Refer to the document supplied with the product The operator should operate according to the instruction under the icon otherwise personal injury may be caused Et lt O In vitro diagnostic equipment Warning and Safety Instruction For in vitro diagnosis only Carefully read the following warning before use and strictly follow it Warning Read the following precautions carefully before using the instrument In case of peculiar smell smog or noise during use immediately turn off the power and remove the plug from the socket and immediately apply for inspection with the dealer or our agent If you continue to use the instrument in that case fire electric shock or casualties may be caused Prevent blood reagent or metal pieces such as staple etc from entering the instru
30. ent K B In general no correction is needed K 1 B 0 However for items tested with the factor method the factor can be used to correct the error of the instrument 11 Dosage Setup Setup of Sample Volume for Initial Test Input the sample volume The range is 3 45uL accurate to 0 1uL If the sample of the item needs to be prediluted before the test select the Predilute option and input the sample volume and diluent volume in the boxes below in turn the volume ranges of the sample to be prediluted and diluent are 2 100uL and 20 450uL respectively as shown in the figure 10934 Volume setup CR Normal Rerun Sample 3 0 Sample 30 Diluent M Reag 2 fo Save Cancel Figure 4 3 Sample Volume for Initial Test Setup of Sample Volume for Retest When the test results exceed the linear range retest may be conducted In the retest the specified sample volume is resucked up according to the test results on the high or low side Input the sample volumes for retest for results on the high side and for results on the low side in turn If the sample of the item needs to be prediluted before the retest for results on the high side select the Predilute option and input the volumes of sample to be prediluted and diluent in the boxes below as shown in the figure 24 Volume setup CR Normal Rerun Sample H 3 0 Vv q Sample EN Diluent Sample L 5 0 300 Reag 2 Save Cancel Figure 4 4 S
31. ess the Add key input the doctor name and press the Save key Delete Doctor 37 Select a section and all doctors in the section will be displayed in the doctor list Select the doctor to be deleted from the doctor list and press the Delete key 5 7 User Management Function Brief To set the privilege and password of a user Select User Management from the System Setup menu to enter the screen as shown in the figure User Daily Testing Calibration Setup Control Setup Ri Admin Yes IY j 3 Name PA Basel Access Setup F Daily Testing Parameter Setup Calibration Setup Control Setup F Result Edit Result Check Maintenance New Save Delete Password Cancel Figure 5 9 User Management Add User Press the Add key input the user name in the User Name input box select and set the privilege and press the Save key Modify User Privilege Select a user from the list reselect and set the privilege and press the Save key Delete User Select a user from the list and press the Delete key Caution Only the administrator Admin can add delete and modify user privilege Modify Password 38 Select a user from the list and press the Modify Password key The screen as shown in the figure will appear Change Password Name Password New Password Input gain Es Revise Cancel Figure 5 10 Modify Password Input the password and new password input the
32. ete key To delete all repair records directly press the Clear All key 295 Caution Only the administrator can add and delete repair records Backup Service Log Debug Blank Configure 2012 08 24 10 54 32 Logging in uu gt 3 Ki Clear Log Explorer Touch Screen System Setup Cancel Figure 11 3 Maintenance Log The list displays all system log records To delete all log records press the Clear Log key Caution Only the administrator can clear logs 173 Backup Service Log i Blank Configure Home system Internal Printer Test Home Reagent Sample Reaction Disk The paper testing of the internal Printer Home Sampling System Initializing Perfusion Wash Sampling System Temperature 2 35 3C Dark AD 0 Explorer Touch Screen System Setup Cancel Figure 11 4 Maintenance Operation Temperature 1 35 30 On the Status Detection page you can operate the status detection of various components of units 74 Backup Service Log Debug Range 65553 340 OK norma O Unknown Refresh Result Main Wavelength 405 Sub Wavelength No D 1 21 31 41 51 61 71 81 2 12 22 32 42 52 62 72 82 3 13 23 33 43 53 63 73 83 4 14 24 34 44 54 64 74 84 5 15 25 35 45 55 65 75 85 6 16 26 36 46 56 66 76 86 7 17 2d 37 47 57 67 ite 87 8 18 28 38 48 58 58 78
33. gure 29 Chemistry test Test Full Name QualijQuan Dei Low Ref High Unit Decin TEST Quan 0 000 38 000 g l X XXX TEST3 Quan 4 000 38 000 gil NOCH 5 Ji gt Test Full Name Quantitative Qualitative Reference fo x 0 Unit D Decimal X XXx T E New Save Delete Cancel Figure 4 9 Non biochemical Items Setup Add Non biochemical Item Press the Add key input the item name full name qualitative or quantitative and reference value of the non biochemical item added in turn and press the Save key Modify Non biochemical Item Select the non biochemical item to be modified from the list modify the full name qualitative or quantitative and reference value and press the Save key Delete Non biochemical Item Select the non biochemical item to be deleted from the list and press the Delete key 4 2 Item Test Methods According to the requirements of the reagent instructions set the test parameters of the item in the Biochemical Setup module and specify the reagent position in the System Setup Reagent Setup module If the item needs calibration make standard setup according to the parameters indicated on the standard substance of the item Refer to 8 1 Standard Setup Enter the Sample Application module and apply for test samples and required standard substances Enter the Test Status module and press the Start button to start the test During the test you
34. he test status and test results 3 Print Report Used to inquire edit and print sample information sample test results and historical reagent blank test records 4 Standard Inquiry Used to inquire standard curves and calibration test results 5 QC Inquiry Used to inquire QC test results including QC data QC charts and QC results statistics 6 Item Setup Used to set the test control parameters of biochemical items and edit non biochemical items for external data entry 7 Standard Setup Used to set parameters of standard substances for application for standard substance tests in the Sample Entry module 8 QC Setup Used to set parameters of QC substances for application for QC substance tests in the 19 Sample Entry module and for statistics of QC results in the QC Inquiry module 9 System Setup Including system control parameter setup reagent setup section setup user management etc 10 Maintenance Used for daily maintenance of the system including data maintenance log maintenance and simple function debugging 20 Chapter 4 Item Setup 4 1 Item Parameter Setup Function Brief To set the control and calculation parameters of biochemical items and non biochemical items 4 1 1 Biochemical Items Press Item Setup on the main screen to enter the Item Setup page as shown in the figure Chemistry test Non chemistry test LB CR LT Full Name TU gt Decimal x Indirect calc Formul
35. ia Caution Test results for which the retest has been finsihed or test results manually added or modified are marked with at the end 66 Delete Test Results Select the records to be deleted from the test records list or select Select All and press the Delete key Print Test Results Select the records to be printed from the test records list or select Select AII and press the Print key View Reaction Curve Click the test records to be viewed and press the Reaction Curve key The system will display the reaction curve of the test as shown in the figure Sample No 120701001 Test ALB1 Result 3 405 g l 7 Prim Sec Prim Sec Print Cancel Figure 9 8 Reaction Curve Press the Print key to print the curve 9 3 Reagent Blank Records Inquiry Function Brief To inquire the historical records of the reagent blank of the specified item Select the Reagent Blank Inquiry page as shown in the figure 67 Date Reagentblank 2012 07 02 15 3 2012 07 03 09 1 151 OR Mi Delete Delete All Print Cancel Figure 9 9 Reagent Blank Inquiry The left list displays all items with the reagent blank test finished Click the item to be inquired and the right list will display the historical reagent blank record of the item Press the Delete key to delete the selected reagent blank record from the list Press the Delete All key to delete all reagent blank records f
36. key to clear the messages from the list Replace Cuvette Press Replace Cuvette and replace all cuvettes in turn according to the prompt messages 6 4 Pause and Stop If you want to pause or stop a test press the corresponding key In which Pause means stopping addition of new tests but the test started will be continued till finished Stop means aborting all tests including cancelation of tests started 53 Chapter 7 QC 7 1 QC Setup Press the QC Setup key on the main screen to enter the screen as shown in the figure Test Target SD Unit OC No JBathNo o ZK HE gt ALB 3 63 0 36 g L ALT 56 1 2 6 U L CRE 36 4 0 26 ummol l i Su gt New Delete Control rule Cancel Figure 7 1 QC Setup Add QC Press the Add QC key input the number and batch number on the screen that appears and press OK to save the setting Add the QC items included for the QC substance in turn Delete QC Select the QC substance to be deleted from the QC substance list and press the Delete QC key Add QC Item Specify a QC substance and press the Add Item key Select Add or the QC item to be modified on the screen that appears input the target value and SD and press the Save key Delete QC Item Select a QC substance from the QC substance list and the QC items included will be displayed on the left list Select the QC item to be deleted and press the Delete Item key 54 Set QC Rule Select a QC
37. lled in place 4 Adequate deionized water and cleaning solution have been added to the specified positions on the reagent tray 5 The waste liquid barrel has been emptied and the cleaning solution is adequate 6 Operate and maintain the instrument according to the instructions and keep the User s Manual in a handy place 3 2 Logging on to the System When the machine is started the CliChem 120 software will run automatically and the system will enter the user login screen as shown in the figure ve Dem Password E OK Cancel Figure 3 1 Login Select a user name and input the password and press the Login key to login or press the Cancel key to turn off the system automatically Caution The user name of the system administrator is Admin and the initial password is 888888 You can change the password freely Please keep the changed password in mind If you press the Cancel key on the login screen the system will be turned off automatically After login the system will conduct self check and initialization automatically as shown in the figure 17 Initializing Checking sampling system Figure 3 2 Initialization Self check and initialization include the following contents Connecting frond end Test whether the communication between the control software and middle computer software is normal Units shaking hands Test whether the status of the various units is normal Sending p
38. ment Otherwise short circuit or fire may be caused In case of abnormality immediately turn off the power and unplug the plug from the socket and immediately apply for inspection with the dealer or our agent Do not touch the electronic circuit in the instrument Particularly touch with wet hand may cause electric shock Wear rubber gloves and use the specified tools parts and components when maintaining and inspecting the instrument When the operation is ended wash hands with disinfectant Otherwise the skin in contact with blood may be infected or scalded or get an electric shock Be very careful when treating samples Be sure to wear rubber gloves otherwise infection may be caused In case the sample enters the eye or wound immediately rinse with plenty of clear water and receive examination by a doctor Use and Disposal of Reagent Prevent the reagent from being contact with skin and clothing during operation In case the reagent enters the eye immediately rinse with plenty of clear water and receive examination by a doctor If you swallow the reagent immediately consult a doctor and drink water generously to spit the reagent If your hand or skin is stained with the reagent immediately rinse with clear water The cleaning solution supplied with the instrument is highly alkaline and should not be in contact with skin or clothing In case your skin or clothing is stained with it immediately rinse with plenty of water to preven
39. nated Pb Hg Cd Chromium Biphenyls PBB Diphenyl Ethers Cr VD PBDE Built in R S e circuit board Shell x O O x O O Display x O O O O O Photoelectric x o O O O o components Internal electronic O O O O O O wire Accessories x O O O O O o Indicates the content of the toxic hazardous substance in all homogeneous materials of the component is below the limit specified in the SJ T11363 2006 standard x Indicates the content of the toxic hazardous substance in at least one homogeneous material of the component exceeds the limit specified in the SJ T11363 2006 standard 2 Description of Mark Environmental protection use period mark Meaning of the mark The electronic information product contains certain toxic hazardous substances with the environmental protection use period of 20 years You can use it within this period When this period expires the product should enter the recycling system 84
40. nd press the Save key Edit Patient Test Results The test results corresponding to the selected patient are displayed on the right list You can add modify or delete the test results Caution Test results for which the retest has been finsihed or test results manually added or modified are marked with at the end Results on the high or low side are marked with and respectively O The added patient sample number must not be an existing sample number otherwise the system will overwrite it automatically 63 Delete Patient Records Select the records to be deleted from the patient records list or select Select All and press the Delete key The system will delete the specified patient records and all corresponding test records Setup To achieve login or logout of the examiner as well as format selection of external reports Examine Patient Results Select the examined patient records from the patient records list or select Select All and press the Examine key The system will finish the examination automatically Before the examination the examiner should press the Setup key to login The patient records examined and those not examined are on white background and grey background respectively Report format Checker Checker Admin Password ES Logon Logout Cancel Figure 9 4 Examiner Login and Logout Caution Each time the report is examined the examiner should l
41. nu of the operation software to enter the Maintenance page Service Log Debug Blank Configure Configure QC Results Backup HET Date 2012 08 24 2012 08 24 Export Import Database Backup Recover History Results Date 2012 08 24 2012 0824 Clear FP History Results QC Results Coon _ Import Calibration Parameters Test parameters Export Import Clear F All Explorer Touch Screen System Setup Cancel Figure 11 1 Maintenance Data Maintenance Backup and Restoration of Configuration Parameters 70 The configuration parameters are the best correction parameters suitable for hardware system obtained during the production of the machine including positional parameter motor control parameter temperature correction parameter gain parameter cuvette blank threshold and optical filter configuration parameter The functions of the various parameters are as follows The positional parameter is used to correct the mechanical positioning of the system such as descent altitude of the sampling probe liquid sucking and spitting positions photoelectric collection position etc The motor control parameter is used to control the working mode of each motor The temperature correction parameter is used to correct the accuracy of the reaction tray and preheat temperature control The gain parameter is used to control the signal gain coefficients correspon
42. ogout to protect the examination privilege against illegal use by other operators Operation Step Enter the Patient Records Setup screen select the current examiner and input password and press Logout Indirect Calculation Select the patient records for indirect calculation from the patient records list or select Select All and press the Calculation key The system will calculate the item results of the selected patient automatically according to the system setup parameters Send Patient Test Results Select the patient records to be sent from the patient records list or select Select All and press 64 the Send key The system will send the test results of the selected patient to the specified receiving software Print Patient Report Select the patient records for which you want to print the report from the patient records list or select Select All and press the Print key The system will generate the patient report automatically Before printing the report you should press the Setup key to set the format of the patient report as shown in the figure Report format Checker Report format Ap iv Print test s full name i Cancel Figure 9 5 Report Setup Report Format Select the paper format of the report from the dropdown options Print Full Name of Item Select whether the full name of the test item will appear on the patient report 9 2 Test Records Inquiry Function Brief To inquire
43. ollowing are included refer to the packing list One mainframe Factory Inspection Certificate CliChem 120 User s Manual Packing List and Quality Analysis Certificate Big and small reagent bottles Assay cup Micro sample cup Caution The accessories packed should be consistent with the packing list If any component is missed or inconsistent with the packing list please contact the retailer 2 1 2 Handling Method The structure of the whole machine is composed of the rack and the sheet metal parts and plastic parts on the surface Two persons are required to handle the machine The two persons stand on each side of the machine respectively put hands on the sides of the bottom racks lift up the machine horizontally and put it on the level desk Caution Keep the packing case for packing before long distance transport The instrument must be put on a level operation desk rather than angular surface 2 2 Installation and Use Environment The product must be installed by professionals In order to ensure the instrument works normally put it in a workplace meeting the following requirements No direct sunshine Nolarge amounts of dust No strong electromagnetic radiation Easy power off operation 14 A level solid desk that is big enough With good ventilation Avoid moist and high temperature Avoid violent vibration and impact Caution 1 The normal working environment for the instrument is
44. onononononononrncnonnnonn eene nete ennn rennen nnn rn enne 41 6 1 3 Standard Substance Application sessi 42 6 2 Sample WSS PTT 44 A PA 47 OF PAGS and OP AAA AAA 53 CHAPTER 7 ii a 54 BVOC 0 A O A 54 EN A T ET TENIS 55 T3 QC d 55 CHAPTER E EE NR E 58 8 1 Standard Setup AAA AA 58 8 2 Standard ee 59 8 3 Standard Inquiry EEN 59 CHAPTER 9 REPORT PRINTING Eege Eege 61 9 1 Patient Records Inquiry A ii 61 9 2 Test Records EE eege 65 9 3 Reagent Blank Records InqUity iue tend hne tas da E EE 67 CHAPTER IULIURNCGEE SY SUB cocino ida 69 CHAPTER 11 MAINTENANCE siii 70 MB RT 70 11 2 Maintenance Instructions 1 inantea cina innert enn a RR a ME NAR NEEN 70 CHAPTER 12 SYSTEM FAILURE AND TREATMENT 78 CHAPTER 13 SAFETY PROTECTION DEVICE AND ACCIDENT IR ALEN I deeg a 80 APPENDIX A TEST EUR MES cosita i n 81 A 1 End Pomt Method x a a 81 A 2 Two Point Method 81 A 3 Rate Method 82 APPENDIX B NAMES AND CONTENTS OF TOXIC HAZARDOUS SUBSTANCES OR ELEMENTS arca cero pn ERR ep rc pae Tr 84 Chapter 1 Introduction Automated Chemistry Analyzer 1 1 Introduction 1 1 1 Product Name 1 1 2 Model CliChem 120 1 1 3 Features Clichem 120 is an analysis instrument for clinical biochemical tests developed by using photoelectric automation and computer technologies The instrument adopts transmission turbidimetry and calculates concentrations of sam
45. opies Al Number of copies 1 C Pages from te Selection AA Collate Cancel Figure 5 4 Printer Setup 5 3 Unit Setup Function Brief To set the unit of results of test items 34 Select Unit Setup on the System Parameters screen to enter the screen as shown in the figure Unit list mg dl mmol L Ze Gees Cancel Figure 5 5 Unit Setup Unit List Displays all units defined by the user Add Unit Press the Add key input the unit in the input box and press the Save key Delete Unit Select the unit to be deleted from the list and press the Delete key 5 4 Port Setup Function Brief To set the IP address and port number of the data receiving server Select Port Setup on the System Parameters screen to enter the screen as shown in the figure Set the IP address and port number of the server on which the data receiving software is installed If automatic and manual data transmission is not needed the port needs not to be set Port Setup Host IP 127 0 0 1 Port mn ES b Cancel ia Figure 5 6 Port Setup 5 5 Reagent Setup Function Brief To specify reagent positions and other reagent information for test items Select Reagent Setup on the System Setup menu to enter the screen as shown in the figure A L L 12 22 L SOLUTION 25 L 26 L y R1 Pos Vol Size R2 Pos Vol Size E Small Small Save Es gt Dele
46. ples according to the Beer Lambert s Law 1 2 Composition and Structure of the Instrument 1 21 Structure Diagram 10 Figure 1 1 Structure Diagram of Clichem 120 Sampling probe 2 Syringe 3 Probe cleaning position Si 5 _ Reagent sample 6 Assay cup 4 Sampling position i reaction tray pick and place opening 8 Rabbl leani 7 Rabble s eR E o Display position 10 Internal printer 10 1 2 2 Right Side Diagram aN quo Di KN 0002930000 9 0 0 0 Ee 00000000 9 006 0 EA mn o0 00 a HIT o L 0 000 0 0 0 0 0 Figure 1 2 Diagram of Interfaces on the Right Side Panel of CliChem 120 1 Keyboard i Eeer 2 USB interface 3 Serial interface interfaces 4 Parallel interface 5 Network interface 6 Power input interface 7 Fuse 8 Power switch 1 23 Rear Side Diagram 1 oF Co N rz Figure 1 3 Diagram of Interfaces on the Rear Side of CliChem 120 1 Cleaning solution waste liquid 3 Bulb replacement sensor interface 4 Cleaning solution interface 2 Ground pole i opening 5 Waste liquid interface 1 3 Performance Steady testing results easy operation and fast testing 1 4 Scope For clinical regular biochemical measurement and other absorption spectrophotometry measurement 1 5 Technical Parameters Test Methods Computational Methods Spectral Modes
47. rameters and worksheet setup and test data input by users All Data Including all above data Export and Import of QC Results To export all QC results of tests in the specified time range The data exported will be saved to the specified path When necessary the QC results in the specified time range can be imported from the file Export and Import of Historical Data EAE To export the patient sample test results in the specified time range The data exported will be saved to the specified path When necessary the patient sample test results in the specified time range can be imported from the file Export and Import of Item Setup Parameters To export the current item setup parameters of the system The data exported will be saved to the specified path When necessary the item setup parameters can be imported from the file Caution Only the administrator can restore configuration parameters restore database import QC data import historical data import item setup parameters and purge data Log Debug Blank Configure Date D 2012 08 24 10 52 28 AAAAAAA dig gt ss e gt i Add Delete Clear All Explorer Touch Screen System Setup Cancel Figure 11 2 Maintenance Repair Record Add Repair Record Press the Add key input the repair records to be added in the window that appears and save the setting Delete Repair Record Select the record to be deleted from the list and press the Del
48. rom the list Press the Print key to print all reagent blank records in the list Caution Results exceeding the reagent blank range are marked with OR 68 Chapter 10 Turn Off System Click Switch Off below the main menu to logout or exit the operation as shown in the figure C Fast Exit Cancel OK E Figure 10 1 Logout and Exit Select Logout to logout and relongin Select Exit and the system will turn off the software and control system automatically after the necessary cleaning Select Quick Exit and the software and control system will be turned off automatically Caution If the current user is a super user when Quick Exit is selected the software will be turned off and Explorer will be turned on and the control system will not be turned off 69 Chapter 11 Maintenance 11 1 Regular Maintenance Daily Maintenance Wipe the dirt on the workbench with a cloth soaked with neutral cleaning solution Weekly Maintenance Gently wipe the sampling probe and rabble with a cloth dipped in alcohol Check whether the flows of the washing water in two cleaning pools are normal Monthly Maintenance Clean the external cleaning solution tank Clean the water supply and drainage system Caution The diaphragm pump and rabble can t be replaced without permission of engineers from BGT 11 2 Maintenance Instructions 11 2 1 Maintenance Procedures for Running and Normal Modes Click Maintenance on the main me
49. se or decrease of the absorbance is in proportion to the concentration of the measuring object 81 Absorbance Time Delay Time Meas Time4 Two Point Method A 3 Rate Method Rate Method The reaction rate is in proportion to the zero power of the concentration of the measuring object that is unrelated to the concentration of the measuring object Therefore throughout the reaction the reactants can generate a product at a constant rate thus the absorbance of the measuring solution is evenly decreased or increased under a wavelength with the rate of decrease or increase AA min in proportion to the activity or concentration of the measuring object The rate method i e the so called kinetic method also called continuous monitoring method is mainly used to determine the enzymatic activity In fact the concentration of the substrate is impossible to be high enough As the reaction proceeds when the substrate is consumed to a certain extent the reaction rate is no longer in proportion to the enzymatic activity Therefore the Rate Method aims at a certain time period 82 Delay Time Measurement Time Rate Method 83 Time Appendix B Names and Contents of Toxic Hazardous Elements 2 il 1 Names and Contents of Toxic Hazardous Substances or Elements Toxic Hazardous Substance or Elements Component Lead Mercury Cadmium Hexavalent Polybrominated Polybromi
50. sed Check whether the perfusion of the hydraulic circuit is inaccurate adequate Check whether the liquid volume correction factor is normal Check whether the status of the syringe is normal Check whether the deionized water has been used up Check whether the pipeline is connected correctly The sampling probe is not positioned Check whether the sampling probe is straight down Whether standard reagent bottles and sample tubes are correctly used Liquid remains on the surface of the Check whether there is dirt on the outer wall of the sampling probe sampling probe Check whether the sampling probe tube is worn Check whether the fountain in the cleaning pool when the sampling probe is being cleaned is appropriate Check whether the sampling pipeline is properly closed Check whether the perfusion of the hydraulic circuit is adequate Check whether the deionized water has been used up The positioning of the rabble is Check whether the rabble is straight down Check whether the rabble is loose incorrect 78 Warning 1 In case of failure of the instrument contact the agent immediately so as to obtain technical support 2 Only professionals recognized by BGT may repair the instrument To replace accessories contact the manufacturer or agent Chapter 13 Safety Protection Device and Accident Treatment Ensure the grounding is normal when using the machine
51. shown in the figure Ho 1 2 3 4 5 5 7 8 8 trip of cuvettes are contaminated it may depress testing speed Do you want to replace them Figure 6 9 Prompt of Cuvette Replacement Select Yes to cancel the test Then you may replace the cuvette Select No to continue the test and skip the cuvettes that can t be used automatically Case 3 When the energy of the cuvette blank is too low all 340nm cuvette blanks are less than 30 000 the system will give the following prompt message automatically Cuvettes blank too large Possible reason illegal cuvettes setting wrong gain setting or Lang s power too low Do you want to ignore it Figure 6 10 Prompt of Energy of Cuvette Blank being Too Low Here you should conduct troubleshooting according to the prompt If the gain setup has no abnormity and clean cuvettes have been put and the problem is caused by the aging of the light source please contact the after service department to replace the light source 6 3 Test Status Function Brief To view the test results and status of the current worksheet Select the Test Status page on the Test Status screen and the real time status of each assay cup sample cut and reagent bottle is displayed with the chart 47 Total RK Remaining time 14 minutes Q EA Status Reagent Cuvette Result Information Routine Dilution Stat Testing Control Finished Standard Waste t o OG e e o Empty C Empty Unkno
52. ss the OK key Step 6 Finish the batch sample application Caution The system generates sample numbers automatically according to the rule of Date Serial Number such as 090903001 In batch sample application the system starts from the sample number input and sequentially increases the sample numbers generated automatically For example when 018 is input the sample numbers of the batch application are 018 19 020 and so on When the application is finished you can make manual modification If the micro sample cup is used select Micro Cup Only when the sample cup type is set correctly can the system treat sample exception accurately If the worksheet has samples not applied for on the current day the software will prompt you to delete them Caution The number of sample positions and reagent positions can be configured freely as needed The default configuration is 9 sample positions 26 reagent positions The combination rule is when 2 reagent positions are reduced 3 sample positions will be increased 6 1 2 QC Substance Application The QC Substance Application screen is as shown in the figure 41 Position 1 ei Small ube Routine C Stat Control C Calibration Control No ZK hd Repeat E A Delete Delete All List Status Cancel Figure 6 3 QC Substance Application Step 1 Select Sample Position If micro sample cup is adopted select Micro Cup Step 2 Select th
53. substance from the QC substance list and the QC items included will be displayed on the left list Select the time for which you want to set the QC rule and press the QC Rule key to enter the screen as shown in the figure Control rule setting ZK ALB 1 value exceed 4SD 1 45 1 value exceed 3SD 1 35 1 value exceed 25D 1 25 2 consecutive values exceed 25D 2 25 3 consecutive values exceed 25D 3 25 5 consecutive values on the same side of target value 5 5 7 consecutive values on the same side of target value 7 7 R Cancel Figure 7 2 QC Rule Setup Select the QC warning rule for the item from the 7 rules and press the OK key to save the setting 7 2 QC Application See 6 1 2 QC Substance Application 7 3 QC Inquiry Function Brief To inquire the test results in the specified time range of the specified QC item Select the QC Inquiry page as shown in the figure 55 Figure 7 3 QC Inquiry View QC Data Select the QC item to be viewed from the left list and specify the date range of inquiry and all test data meeting the criteria will be displayed in the data list on the right View QC Chart Select the data points to be drawn from the data list and press QC Chart to display the QC chart 56 All C Daily Cumulative ZK ALB PERENNE NEIN E EE A E A E PERE EETA ee MT INNEN IUE INN NM E E PI PNE NER TE a 1 2 3 4 5 6 7 8 9 10 11 12 Target 3 630 SD
54. t injury Used test tubes and other consumables for the instrument should be disposed properly as medical waste or infectious waste If contaminated by blood etc they may be infected by pathogen Voltage Connection and Grounding of Power Supply Ensure the power supply and grounding environment of the instrument are good and steady Never insert the power plug into a socket other than 220V AC socket Otherwise fire or electric shock may be caused Be sure to use the three core cable supplied with the instrument in installation ensure good grounding and put the instrument in a place for easy power off operation Otherwise fire or electric shock may be caused Never damage the insulating covering of the cable Do not jerk the cable or hang heavy objects with the cable Otherwise short circuit or open circuit may be caused thus causes electric shock or fire Be sure to turn off the power before connecting peripheral equipment Otherwise electric shock or failure may be caused In accordance with the Pharmaceutical Affairs Law modification of medical instruments is prohibited Table of Contents HOW SARL NULA Lata A EE Ep Mu 2 MAJOR ICONS USED IN THE INSTRUMENT nmm 4 WARNING AND SAFELY INSTRUCTION isis ani 9 TABLE TIPO BROS rca dee Fi CHAPTER I INTRODUCTION EE 10 LI Doo top 10 1 1 1 Product Name Automated Chemistry Analyzer seen 10 1 1 2 Model CliChem Oo nre iR REIR EEN 10 1
55. te Delete All Check Cancel Figure 5 7 Reagent Setup Modify Reagent Information Select an item set the positions and remaining volumes of reagent 1 and reagent 2 respectively and the model of the reagent bottle and press the Save key Caution The last two reagent positions are for diluent and deionized water respectively Never put other reagents in them Delete Reagent Information Select an item and press the Delete key to delete the reagent information of the item Press the Delete All key to delete all defined reagent information Reagent Test Press the Reagent Test key and the system will detect the remaining volume of the reagent for which the position has been specifid 36 Caution Before reagent test specify the reagent positions corresponding to the various items Otherwise reagent test is impossible 5 6 Section Setup Function Brief To set the sections and doctors involved in patient information entry Select Section Setup from the System Setup menu to enter the screen as shown in the figure Department Doctor D DOCI DOC2 DOC emen Figure 5 8 Section Setup Add Section Below the section list press the Add key to input the section name and press the Save key Delete Section Select the section to be deleted from the section list and press the Delete key Add Doctor Select a section and all doctors in the section will be displayed in the doctor list Below the doctor list pr
56. ted automatically If option 2 is selected the test results will be sent to the server specified by the system on real time basis The supporting receiving software needs to be installed on the server Reaction Tray Temperature Set the target temperature of the reaction tray according to the requirements of the reagent instructions 5 2 Report Setup Function Brief To set the title annotation and printing format of a general report From the system parameter screen select Report Setup to enter the screen as shown in the figure 33 Report title Report annotations ze Print Sequence Note Printer setup Save Cancel Figure 5 3 Printing Setup Report Title Set the title of the patient report such as Inspection Report of xxxx Hospital Report Annotation Set the remark of the patient report such as Note The inspection results are for the sample only Printer Specify the type of printer to be used Select Internal Printer or External Printer Printing Sequence Set the printing sequence of the items in the general report Remarks Set the remarks that may be needed in the general report Printer Setup When External Printer is selected the printer needs to be set up Specify the printer name paper attribute etc as shown in the figure Yv r Printer Name HP LaserJet P1007 Properties Status Ready Type HP LaserJet P1007 Where USBOO3 Comment r Print range C
57. temperature of 20 C 30 C and HR40 80 2 After installation try to avoid frequent movement To move the instrument use a steady cart The angle of inclination should not be greater than 15 when it is moved 3 It must be installed and moved by authorized professionals 2 3 Requirement of Power Supply The power supply must be a c 110V 220V 50Hz 60Hz with good grounding If the voltage change of the lab is gt 10 it is suggested to install an external voltage stabilizer of above 1500 W The machine is a precision instrument automatically controlled by computer therefore it must be equipped with UPS Uninterrupted Power Supply of above 1500 W Warning 1 The AC power supply must be grounded properly 2 Check that the input voltage complies with the requirement of the instrument The AC power supply must be stable Sharing a power supply with high power electrical appliances is prohibited It is better to be equipped with a regulated power supply 3 Before connecting the cable check that the switch of the instrument is off 4 In case of smog peculiar smell or abnormal noise immediately turn off the power and contact the retailer 5 To unplug the cable grasp the plug rather than the wire 2 4 Installation Putthe machine on the level desk Connect the machine and AC power supply with the cable Connect the cleaning solution bottle and waste liquid bottle to the machine according to the marking on
58. ts Before confirming the start of the test confirm the above information To modify the information press the Cancel key Or press the OK key and the Test Sequencing screen will appear as shown in the figure Test sorting Normal PositionSample Test Repeat Type Status Remar 120824 ALT NE Boutine hay 1208241 ALB 1 Routine 120824 CR 1 Routine gt Total 3 iv Check reagent volume By Test By Sample OK Cancel Figure 6 8 Test Sequencing The system sorts the tests according to the test sequence specified in Test Sequence Setup see 4 1 Item Setup by default If you want to readjust the sequence you can press the Sort by Item key or Sort by Sample key or use the mouse to drag the items in the list After adjusting the test sequence press the OK key to start the test or press the Cancel key to give up the test Caution The Status column in the list indicates whether the test has been finished If the test has been finished Finish is displayed otherwise nothing is displayed If a test is to be conducted for the first time after the machine is started or the cuvette is replaced before adding the sample the system will detect cuvette blank automatically When the detection is finished the following cases may occur Case 1 All cuvette blanks are valid and the system starts the test 46 Case 2 Some cuvette blanks are invalid and the system prompts you whether to replace the cuvettes as
59. wn Q Untested Error Q Testing O Completed O Abnormal Retest Replace cuvettes Statistics Print Cancel Figure 6 11 Test Status Test Status Select the Reagent page on the Test Status screen and view the use situation of the reagent involved through the list 48 Total aes Remaining timef Q Status Cuvette Result Information SOLUTION Start Pause Stop Curve Hetest Replace cuvettes Statistics Print Cancel Figure 6 12 Test Status Reagent Select the Assay Cup page on the Test Status screen to view the test situation in each assay cup through the list 49 Total a Remaining time 10 minutes Q hlacksampe 43 Sample 4 Status Reagent Cuvette Result Information Waste Waste Testing Testing Testing Re Le Heplace cuvettes Statistics Print Cancel Figure 6 13 Test Status Assay Cup Select the specified assay cup from the assay cup information list and press Reaction Curve to view the reaction curve of the test as shown in the figure Cuvette No 1 Blank 0 Sample Test Result 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 18 Prim pm Sec Prim Sec Last Next Print Cancel 50 Figure 6 14 Reaction Curve Press Previous and Next to view the reaction curve of each assay cup position in order Press the Print key to print the reaction curve of the current assay cup position Press the Return key to exit r
Download Pdf Manuals
Related Search