CliChemH Semi-auto Chemistry Analyzer User's Manual
Contents
1. 35 9 7 TROUBLE SHOOTING 35 8 8 THE INSTRUMENT S 5 8 36 APPENDIX GENERAL SPECIFICATIONG cssssccsssssccsssssccsssssccccsssscccssssscsssssscsseees 38 APPENDIX II SERIAL CONNECTION PROTOCOL 00 ccsssssccssssrcccssssccssssscsssssscseeees 39 How to use the manual General Thank you to be the user of CliChemH This manual is a user s guide for CliChemH Semi auto Chemistry Analyzer and contents system installation operating procedures System parameters setting and maintenance We suggest that the user read the manual carefully Please read the ext Printer manual for the system with ext Printer The instruments with different versions or collocations will have some differences in functions Symbols description Symbols in the manual NOTE Notes contain additional information or tips when using the instrument ATTENTION Cautions Cautions should be followed carefully to ensure your instrument work correctly and to avoid unnecessary personal injury Symbols on the instrument This symbol means that the labeled item is hot while the instrument is in use Don t touch the labeled item as you could be burnt The symbol is labeled on the lamp bracket of optic system This means that the labeled2. ES Sis NEEE Soe bee E 1320 NEM a Instruction 0 5 Unit sec window Screen 2 17 1 Instruction window Aspirating distilled water Put a tube with distilled water under the sample tube and press Sample key figure 1 4 The measure result will be displayed on the result window and on the reaction window 2 Instruction window Aspirating reagent blank Aspirating Sample Blank Hold the reagent blank or sample blank under the sample tube and press Enter key or sample button the programmed solution will be 22 aspirated and measured The process and result of the measurement will be displayed 3 Instruction window Aspirating Sample Hold the sample under the sample tube and press Sample button The programmed solution will be aspirated and measured The process and result of the measurement will be displayed 4 Calibration will be described in Chapter 3 5 Control will be described in Chapter 4 2 5 3 Changing test When changing over from one test to another washing of the flow cell is required to prevent reagent carry over causing wrong calibration and measurement result To wash the flow cell e Place a container of distilled water under the sample tube Press Rinse key The aspiration flow cell system will be washed continuously now until the Rinse key is pressed again Let the flushing continue for about 30 se
3. test parameter Kinetics Unit ot Sample ison Norris Teperature Reagent o g NEN Wavelength 340 Aspirate sop 241 Factor linearity I5 A Delay time s m ds Test time s 4 Linear range Change mode Screen 2 11 Programming menu 3 Click Save button to save the modification or click Cancel to ignore 18 2 4 2 Programming new assays 1 Select a free button of assays by clicking Pgdn button then click the button 2 Input parameters 3 Save the input 2 4 3 Calibration parameter Select Calibration Calibration setting window will be open standard concentration 1 Mum of std inear no linear Num of repeat Screen 2 12 Calibration setting menu 1 Calibration for linear tests otandard number means that how many standards will be measured The measured results will be averaged Input the number by clicking the window number This parameter determines how many standards with the same concentration will be used for calibration The results of multiple measurements will be averaged by the system Select OK to confirm the selecting Select Exit to go back to above menu with modify 2 Calibration for non linear tests otandard number means that how many standards will be measured The standards are different concentrations The measured results will be a calibration cur
4. or its Endpoint The color of the reaction will remain stable and constant for certain period of time During this time a 20 measurement in Absorbance is taken b Endpoint Bichromatic Bichromatic is actually endpoint determination measured at two different wavelengths The advantage is that some unwanted interference due to the color of the serum sample can be eliminated by subtracting the measurement done with the second wavelength filters This can be done when you select a sub wavelength in Parameter change menu It was described in 2 4 1 c Endpoint determinations against a standard Curve d Endpoint determinations against a Multi standard Curve This is a normal endpoint determination in which linearity may not be perfect throughout the whole range that is interest As a result it is calibration curve a number of standards instead of a single standard e Kinetic Kinetic determinations are tests whose enzyme activity is measured continuously over a certain period of time and finally referred to 1 minute f Twopoint After a pre defined incubation time two absorbance readings are taken at different and programmed time interval From the delta absorbance between the two measurements the final result is calculated Each of the measurements taken is a mean of a large number of readings taken in quick succession 2 4 6 Save the Change After select the measure mode Select Save change to save the selection The menu wi
5. Drop the roll of paper into the printer paper well in back e Feed the paper through the paper slot of the cover then close the cover e Set the screen properly position Set the screen in properly position Figure 1 1 1 1 6 Flow cell and cuvette system Figure 1 2 e Remove flow cell cover e Insert the flow cell or cuvette into the flow cell holder e Make sure the surface with characters of the flow cell is faced to user Note A Keep the surface of the flow cell cuvette clean touch it by fingers 10 1 2 System overview 1 2 1 Front View 1 Pump cover Open the cover user could change the lamp or maintain the pump Flow cell cover Sample tube Sample button 5 LCD Screen Hot key Power on indicator Printer cover Figure 1 3 1 2 2 Keyboard Functions RINSE PRINT PAPER LAMP LEFT RIGHT ENTER Figure 1 4 11 Soft keyboard Open or close soft keyboard Rinse On Off Pressing this control will switch on the sipper pump in a continuous mode press the key again will stop the pumping action at the end of a complete cycle Feed Paper Control the printer paper for the embedded printer Print Set the printer enable or disable Lamp On Off off or turn on the Lamp Left This key is used to go backwards in a procedure Right This key will advance the cursor to the next position 74 Enter This key is used to confirm an entry via the aim ke
6. than those specified Never leave a Reagents sample mixture in the flowcell for longer than necessary Always clean the flowcell after a batch of measurement and keep the flowcell filled with distilled water when not in use Verify the front covers closed while the instrument in operation Avoid touching the mechanism such as the sipper mechanism inside the instrument while the instrument is operating This may cause operation stop or damage the instrument Chapter 1 A Brief Description CliChemH is universal photometric semi auto chemistry analyzer The advanced software based on Windows CE gives the instrument friendly interfaces which meet the individual requirements of clinical chemistry laboratory B 47 of the most commonly assays are stored the flashing RAM of the CliChemH which enables user can start working right away with the instrument 130 of assays can be programmed B 6 Analytical Modes Endpoint Bichromatic Liner regression Multi Calibration Two point Kinetics B user could connect the unit to the PC of clinic lab by RS232 interface Options Keyboard B Power off protection real time data saving 1 1 Installation 1 1 1 Unpacking Carefully unpack the instrument removing it from its plastic bag Keep the boxes and packaging material until being assured that nothing is missing that the unit has no internal transport damage and are working properly 1 1 2 Instruments location The CliC
7. tsi tns ett 23 CHAPTER 4 CONTROL c 27 S MEG miri NEUEN Km 27 4 2 PROGRAM CONTROLS a 27 4 3 MEASUREMENT CONTROLS 27 CONTROLS 27 CHAPTERS REPORT em 29 551 SUMMARY TITTEN 29 SA RINE IN T oire 29 ES aee E E E 32 5 HISTORY RECORDS 32 REMOTE SERVICE 33 CHAPTER 7 CLOSE SYSTEM X445 ee eed aetate gen ds pese 33 CHAPTERS MAINTENANCE Pea euo FERE REEF RSEN RETE HESS RE CHR FEN E ette esee een eve 34 zr NRW 34 CLEANING THE OUTSIDE a eto 34 6 3 CLEAN PROCEDURE FOR THE FLOW CELL 34 5 91 Was ina WHET CHANGING debe bessere bebes 34 OU osse aa 34 8 3 3 Closing the system the closing eene eene 35 8 4 REPLACEMENT THE LAMP 35 8 5 REPLACEMENT OF THE INTERNAL TUBING 35 8 6 REPLACEMENT THE anette
8. 1 FOWERING 15 2 2 BASIC OPERATING LE 16 242 4 MOUS TREE EET 16 2 2 2 deoa et 16 2 23 OFLC YOGIC 16 2 3 MAIN MENU AND SYSTEM PARAMETERS 0 16 2 4 PROGRAMMING TEST 5 4 4 4 18 2 4 1 Modne ds tane d aane 18 2 4 2 NOW 19 2 4 3 Callbratton eh disc ool 19 2 4 4 Contor etia 19 2 4 5 LU ECL MCCC oR rg 20 2 4 6 SAVE re ETS 21 2 4 7 ONE ORTON EE TORT EE 21 2 5 PERFORM TEST REI 21 2 5 1 Test tet be 21 2 9 2 NS 22 2 3 oT EH 23 CHAPTER3 CALIBRATION BY 1 20 1 eese ee eeeeesesssoos 24 CREE zr REN RET 24 Su PROGRAM CALIBRATION 24 9 9 PERFORM LINEAR TES TO 24 3 4 PERFORM THE CALIBRATION NON LINEAR 5 6 00 23 SOS BIST ABIBEATIOBAA te sre tae eee
9. CliChemH Semi auto Chemistry Analyzer User s Manual 7 0 765 4 0007 2 8 997 5 3487 2 665 6 5 127 BGT BioGen Technologies See t s ww gt 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 2 5e CONTENTS HOW TO USE THE MANUAL 3 SAFETY PRECAUTIONS AND POTENTIAL 4 1 A BRIEF DESCRIPTION 8 1 1 E 9 1 1 1 8 1 1 2 A A 8 Ld POW CT 9 1 1 4 Connect instrument to 9 1 1 5 Paper Instalati a a 9 Set the screen properly 5 10 1 1 6 Flow cell and CUV ELLE 10 OVERVIEW 11 1 201 ll 422 Keyboard 11 72539 142012 2 2 HTTP 12 1 2 4 PLOW COMA 13 129 Lamp and 13 CHAPTER 2 OPERATING 5 4 2 4 22 22 2 15 2
10. Power off in the Main menu 1 2 3 The system will store the parameters and the results of tests The screen will display aspirating distilled water Place a container of distilled water under the tube Press Sample button Rinse will take few minutes The screen will display Turn off the System Turn off the power ATTENTION Cautions Never power off the system without performing the closing procedure It will cause that lost of the data and influence the measurement 33 Chapter 8 Maintenance 8 1 General The CliChemH is a Clinical Semi auto Chemistry Analyzer which requires only a minimum amount of maintenance Some general maintenance is necessary to keep the instrument in an optimal condition 8 2 Cleaning the outside Always keep the outside of the instrument clean and free dust You can wipe the outside with a damp not wet cloth and a mild detergent Wipe the display screen with a soft nonabrasive cloth ATTENTION Cautions Do not use any type solvent oil grease silicone spray or lubrication on the instrument 8 3 Clean procedure for the flow cell The inside of the flow cell should be kept as clean as possible to assure good and reliable measurements To keep the inside clean follow the following procedures 8 3 1 Washing when Changing tests When changing over one test to another some washing of the flow cell is required To wash the flow cell e Place a container of d
11. conds e Go back to the Fixed test menu the new assay be started now 23 Chapter 3 Calibration by standard 3 1 General Certain tests require calibration by 1 or more Standards Calibration results are stored in the flash memory of the analyzer and can be used again for future measurement Calibration can be programmed and subsequently done for different measurement mode Endpoint or Twopoint For Endpoint the calibration could be with without Reagent Blank and or Sample Blank For Twopoint the calibration could only be with or without Reagent Blank The calibration by standard should be performed depending on the stability of the reagents batch of the reagent and type of test The new ones will overwrite the previous calibration data in the flash memory 3 procedures should be performed for the calibration by standard e Program calibrations e Measurement of calibrations e List calibrations 3 2 Program calibration The calibration parameters could be programmed in the menu parameter modify see the screen 2 14 The setting was described in 2 4 2 3 3 Perform linear tests For linear tests the relation between Absorbance and Concentration 1 a linear Straight line This type of test is normally calibrated with one or more standard s of 1 concentration and with or without Reagent Blank The calibration can be run at any time during a test run after the test has been selected Select Calibration in
12. d option Connect the ext Keyboard to the instrument when the analyzer powered off You can use the keyboard just like to operating a PC keyboard 2 2 3 Soft keyboard You can use the hot key Or the mouse to click the icon soft key to pop a soft keyboard Screen 2 5 Soft keyboard and click the icon again the soft keyboard will be close If you want to move the keyboard please click the its upper blank area and drag it away Click here when dragging 388 Shift icon soft key Screen 2 4 Soft keyboard 2 3 Main menu and system parameters setting After the instrument initialization the screen will display the following Fixed test Screen 2 5 Test survey menus 16 Select Main the screen will change to BGT BioGenTechnologies Calibration list Control list Report Serial trans About Power off Sys setting T t Screen 2 6 Main menu 7 Click Sys Setting ID C elorimetry mode Date Format _ Flowcell D M Y Hospital Cuvette O M D Y Date D M Y 2008 Printer Select Time Format Time i un External Printer 24 Hour Pump speed 5 s PEL Laster 6 Internal Printer 12 Hour Parameters 0 T fi A 40 0 E Print instantly Scree
13. d to be input and each can t be longer than eight characters All the no chemistry items will be saved if RT 1904 is closed correctly Item Setting 1 X O A NENNEN L 1 JL J Screen 5 2 Edit In the window of By patient select one patient line and then click setting In the Item edit window input no chemistry item result this item will be printed in General mode report 3 5 3 Print by test In the state of Screen 5 1 click By test a new window will be open Select the Item to be printed then click Print all test result of selected item will be printed If you want print all items just select the Select check box 5 4 History records In the state of Screen 5 1 click History a new window will be open CliChemH can store 3500 pieces of records at most In the new window drag the scroll bar you can see about all test results of history During the operation of print delete and data transfer click Select all check box you can do the operation on all records Input the order number of patient you can do the operation on selected records Patient No can input as following 1 3 6 2 1 5 3 1 4 5 6 4 3 4 5 7 32 Chapter 6 Remote service CliChemH Lite Version can t support the remote service Chapter 7 Close system At the end of the working you must perform the Closing procedure by selecting
14. e Uses a screwdriver unscrew these seven screws Figure 8 1 3 Turn the instrument back to normal position 4 Set the LCD screen to vertical position Figure 8 2 5 Lift the top cover of instrument gradually and open the front side about 3 inches first Do not use too much force because there are cables between top and foot cover 6 After open the machine you can see the inside distribute of top and foot cover like figuer8 3 7 Find the LCD connector on the main board and open it carefully 8 Then turn over the top cover disconnect 5 other cables Set up the machine in reverse order Pillar x 7 Figure 8 1 36 Front side Mouse Cable 10 Figure 8 2 Figure 8 3 T _ 2I x c m Ee Foot cover PRINTER POWER 4 37 Appendix General Specifications Weight 10 kg Dimension 450mm L x330mm W x140mm Power supply 90 250VAC 50 60Hz Power consumption 150 W max Fuses 3 15A slow blow type 5x20mm Operating condition 15 C to 32 C RH 85 max Storage condition 20 C to 50 C RH 85 max Display 7 color LCD 640x240 256 colors Measurement range 0 000 2 500 abs Resolving power 0 001 abs display 0 0001 abs calculation Interference filters 340nm 405nm 500nm 546nm 578nm 620nm and 670nm Half band width lt 10nm Lamp Tungsten halogen lamp 6V 10W Temperature co
15. f the reagent is stored properly as the requirement E g cooled or frozen storage before using Check for proper programming in parameter setting menu according to the specified reagent instructions Check for volume required for each material Check for proper and calibrated pipette to prepare the solution Additional Precautions Flammables Avoid using dangerous flammable material around the instrument the Measured Results For proper use of the instrument measure control samples and monitor the instrument during the operation An incorrectly measured result may lead to an error in diagnosis thereby posing a danger to the patient Treat all reagents according to the manufacturer s recommendations Refer to the reagent kit box and package inserts or product information sheets for specific instructions Make sure that the sample reagent mixture does not contain any blood clots dust or other insoluble contaminants If insoluble contaminants are contained in the sample correct measuring values may not be obtained Application The instrument is designed for clinical chemistry test analysis using water soluble samples and reagents Please note that other types of analysis may not be applicable to the instrument Operation and Maintenance During operation and maintenance of the instrument proceed according to the instructors and do not touch any parts of the instrument other
16. hemH should be located on a flat surface which is not exposed to heavy vibrations i e centrifuges etc and direct sunlight The ventilation openings in the bottom plate and at the rear of the instrument should not be blocked Note Environmental requirements Ambient temperature operating 15 32 C Relative humidity 20 85 Transport and Storage Environment Temperature 25 C 55 C Humidity lt 93 Atmospheric Pressure 86 106 1 1 3 Power requirements e 110 AC250V e 50 60 Hz 150 1 1 4 Connect the instrument to AC power Plug the power cord into the instrument Plug the power cord into an AC electrical wall outlet ATTENTION Cautions e AC power outlet must be connected to ground e Shut Power off the power if smog special smell special sounds the inside of the instrument contact your supplier e Hold the connector when you pull off the power cord Never pull the cord directly 1 1 5 Paper Installation e Remove the paper cover by pulling up at the top end of the cover e Unroll about 10 inches of paper and place the roll on the table behind the instrument e Feed a cleanly cut edge of the paper from the back into the printer e ragged edge wrinkled paper will be difficult to load could cause a paper jam e Feed just over 1 inch of paper in and then press the feed paper key several times to feed over 3 inches of paper
17. isplay as following BGT BioGenTechnologies Sipper distilled water WaveLength nm peo c Bs po pe pu Deviation of Abs Lz EN E Screen 2 2 Raise test tube of distilled water up to the aspiration tube press Rinse key to rinse the flow cell for about 20 seconds then press the Sample Button to aspirate the distilled water After you hear the control unit valve cycle remove the tube The semi auto chemistry analyzer will now read and save the absorbance reading for water for all seven filters in the machine If the absorbance reading is too high or too low the following screen will displayed BGT BioGenTe CliChemH Absorbency deviation too big Are you retry x WaveLength nm 670 Deviation of Abs 900 000 1 000 000 99 9 Fes Screen 2 3 Select the system will ignore the deviation above and move to test menu Select Yes and raise the test tube of water up to the aspiration tube and press Rinse to rinse the flow cell After a few seconds press Rinse again to stop the 15 rinse and then press the Sample Button If the above screen still displayed contact the supplier 2 2 Basic operating 2 2 1 Mouse The instrument has different configure for different version CliChemH plus has a special mouse designed for PDA or instruments e CliChemH lite Normal mouse for PC USB interface 2 2 2 Keyboar
18. istilled water under the tube Press Rinse key The flow cell system will be washed continuously now until the Rinse key is pressed again Let the flushing continue for about 2 minutes 8 3 2 Washing twice a day The following procedure is needed twice a day to wash out those residues from the wall of the flow cell which cause bad filling of the cell e With the solution of neutral detergent such as Tweenum 20 Let the neutral detergent stay in the flow cell for 2 3 minutes The distilled water added some detergent is better The ratio of the detergent is depending on the detergent used Normally a 1 5 solution is adequate e Rinse with distilled water without detergent for about 1 minute 34 8 3 3 Closing the system by the closing procedure At the end of the working you must perform the Closing procedure by selecting Closing system 1 The system will store the parameters and the results of tests 2 screen will display distilled water 3 Place a container of distilled water under the tube Press Sample button Rinsing will take few minutes Leaving the distilled water inside the flow cell 4 The screen will display Turn off the System 5 Turn off the power ATTENTION Cautions Never leave Sample Regent inside the flow cell for a long period of time 8 4 Replacement the lamp 8 5 Replacement of the internal tubing 8 6 Replacement the fuse The fuse is situated at the rear side of the a
19. item could lead to personal injury and or damage to the analyzer The symbol is labeled beside the power outlet and some external interface _ The symbols for SERIAL NUMBER the serial number shall be after SN or below the symbol adjacent to it The symbol means the product is in vitro diagnostic medical device The symbol indicates the manufacturer and its address after which are shown its name and address The symbol indicates EU representatives of the manufacturer and their addresses after which are shown their names and addresses The symbol indicates biological pollution marked in the where the instrument contacts the clinical reagent The symbol appears in black side and yellow background The symbol indicates temperature range of the analyzers during storage and transportation Safety Precautions and Potential Hazards General Before you start installing and working with the analyzer you should read the safety precautions and regulations shown in this chapter Operator Qualification Please note that the operation with Chemistry analyser should be carried out only by the docior or clinical inspector who has undergone necessary training provided by the sales agent Service Technician Qualification To install maintain and repair the instrument a service technician has to be trained on the instrument by the manufacturer or their representative A service technician is a
20. led down Chemical The operator is responsible for taking all necessary precautions against hazards associated with the use of clinical laboratory chemicals Specific recommendations for each reagent used with the analyzer are normally found on the manufacturer s package inserts or the on the product information sheets for each chemical Wipe up any reagent spillage on the instrument immediately Biohazardous Materials As with all vitro diagnostic equipment patient samples and serum based quality control QC products that are assayed on this system as well as all waste from the waste container should be treated as the potentially biohasardous All materials and mechanical components associated with the sampling and waste system should be handled according to your facilitys biohazard procedure Use the personal protective equipment recommended by your facility when handling any of these components Detailed recommendations Samples Treat all samples as potentially bionaazardous and infectious If any sample is spit on the instrument utilize the correct personal protective equipment PPE gloves lab coat etc wipe it up immediately and clean the contaminated with a disinfectant Waste solutions and solid wastes Avoid direct contact with waste solution and or solid waste Both should be handled as potentially biohazardous Dispose of waste solution and or solid waste according to the relevant governmental regulations Con
21. ll change to the test enter menu Select Enter to perform the test procedure 2 4 7 Return Select Exit to go back to the test enter menu 2 5 Perform tests Select the test to be performed in the menu of test overview and select to go to the menu of test procedure in the menu of Test enter 2 5 1 Test procedure menu The menu of test procedure is displayed as following 21 End point UA 1999 12 15 36 9 x 1 340 distilled water Screen 2 16 Test procedure menus 1 Factor window Factor 2 Result window Test result 3 Control Perform the control test 4 Calibration Perform the calibration test 5 Print Print the test result 6 Change Change the sequence number tested 7 Time Display the time 8 Temperature Display the temperature of the flow cell 9 Lamp Show the status of the lamp On Off 10 Wavelength Show the wavelength selected 11 Instruction window Display the instruction information 12 Return Return back to above menu 13 Reaction window A curve will be displayed to represent the reaction 2 5 2 Perform Follow the instructions displayed on the instruction window End point UA 1999 12 15 Factor 0 000 i 36 9 Sample eL rr mre 0 000A j ON 0 0004
22. lso expected to be familiar with the normal operation of the instrument as described in the User s manual the special operations as described in the service manual Electrical To use analyser safely pay attention to the following items To prevent the risk of electrical shock and or damage to the instrument Operator should not open the white cover of the instrument Only authorized personnel for example service technicians may open the instrument to perform maintenance or repair Touching the main board when the power is on may cause severe injury or death Any problem please ask for helps from your supplier Mechanical There is no risk presented by the mechanical parts of the instrument when the instrument is closed If the covers of the instruments are removed mechanical parts could cause personal injury or the instrument may be damaged if the following advice is not being considered DO NOT wear loose garments or jewellery that could catch in mechanisms DO NOT put your fingers hands into the pathway or any part while the analyzer is in operation DO NOT attempt mechanical repair unless the instrument is not in operation or OFF Lamp The source lamp becomes extremely hot during operation never touch the lamp when it is on Look directly into the light path of the lamp may cause eyes damage too If the lamp needs to be changed always switch off the lamp by switching off the instrument and then wait until the lamp has coo
23. menu of test procedure 1 Instruction window will appear Standard Hold the standard sample under the sample tube and press Sample button The programmed volume will be aspirated and measured The process and result of the measurement will be displayed 2 Instruction window Standard 74 Repeat Following the instruction of the instruction window Calibration Endpoint Linear Old Fac 0 300A 0 00 Standard 1 0 0004 Save Cancel 0 3004 0 5 Unitisec Screen 3 1 24 3 The result will displayed on the result window and the standard curve will be displayed in same time User can save and print the result 3 4 Perform the calibration of non linear tests Non linear tests are those tests where the relation between Absorbance and Concentration is not linear These tests are normally calibrated on more than 1 standard of different concentrations The analyzer has a special arithmetic to link the calibration points to a calibration curve The measurements for patient or controls are then interpolated automatically depending on the curve The calibration can be run at any time during a test run after the test has been selected Select Calibration in menu of test procedure 1 Instruction window will appear Aspirating Standard Hold the standard sample under the sample tube and press Sample button The programmed volume will be aspirated and mea
24. n 2 7 Sys setting menu 1 Setting time and date 2 Printer Select e Printer Inside If you select Printer Inside the Printer type can not be selected e Printer Outside If you select this you need to select the printer type also 3 Inputting the Hospital name Select Serial trans the screen will display the following Screen 2 8 Serial transfer The test result in CliChemH can be transferred to Desktop PC through standard RS232 Cable the serial port of PC should be set as following 19200 baud Even Parity 8 bit of data and 1 bit of stop Details of Protocol please see Appendix Il 17 2 4 Programming test parameters CliChemH has a built in menu of 130 assays 47 assays of most commonly applied data reduction formulae are pre programmed 2 41 Modifying preprogram Click Test button in main menu The screen will display the following Fixed test Screen 2 9 Test survey menus 1 Click the button which will be modified such as UA The screen will display the following test parameter Kinetics Test parameter Unit Sample 500 Norms Temperature Reagent Wavelength pao spirate Bon Factor linearity is Delay time error Linear Test time Screen 2 10 Test Enter menus e Select Edit to modify the parameter of the test 2 Modifying parameters Note the linear range should be input according to the reagent instruction
25. nalyzer It is mounted in the fuse holder beside the power switch Pull out the fuse holder lid and the fuse can be replaced easily Replacement fuse should be the following rating Fuse rating 250V 3 15A ATTENTION Cautions Never mount fuse of wrong rating 8 Trouble shooting 1 The analyzer could not power on Check the power cord Check the fuse Check AC power 2 lamp couldn t turn on Check the connector of the lamp Change the lamp 3 Not Print Check the setting Check the cable Assure that printer powered firstly 35 4 Non aspiration of sample Check the pump tube Check tube pipeline Rinse and check the flow cell 5 The result of water blank is too high Check the lamp Change the distilled water Rinse the flow cell 6 Repeats are not good Check if there is air bubble in flow cell 7 Controls out of the target Reagent validity Assure the program is correct quality of controls test again by changing the mode Check the flow cell and select a new reagent and control 8 The aspirate volume not stable Liquid system blocked Rinse the Tube pipeline or change the tube 8 8 The instrument s disassembly If the user meets some problems and needs to open the instrument you can do as follow 1 Turn over the instrument 2 From bottom of the instrument you can see seven plastic pillars with screw hol
26. ntrol Peltier 25 C 30 C 37 C 0 1 C and ambient temperature Flow cell 30ul quartz flow cell 38 Appendix 11 Serial Connection protocol 1 Serial port state Data is transmitted at 19200 baud With 1 stop bit 8 data bit and Even Parity 2 Message format The initial parameter must be the capital letter each line consists of 12 data following order Parameter Possible values Space mark Initial parameter Department Character or NULL Sex Character or NULL 0 Male 1 Female Name of test Character Result Character Units of measurement Character Checksum All of parameter All of soace mark 3 Send over CliChemH sends a character string TRANSFER FINISH when the task has been completed Example Biachi 0 43 1 136 00 g L 0794 Rossi 1 40 2 TP 147 00 g L 0765 Tony 0 6 3 TP 35 00 g L 069d TRANSFER FINISH 39
27. ols will be displayed on the screen Controll Contral statistic This month Month Dec fon poor 350 sp P 000 p non 250 cy 000 pooo Controlz Ave es 000 sp f 000 D onu zsp 000 000 asp Screen 4 3 3 Print the result by selecting the Print 4 Select Exit to go back to the above menu 28 Chapter 5 Report 5 1 Summary In this part three report styles are provided By patient By test and History you can select one style from four according your requirement a Screen 5 1 5 2 Print by patient In the state of Screen 5 1 select By patient a new window will be open Operation guide 1 Update patient information Select one patient the correspondent line is activated Inout name department age and sex click Update then the patient information is change into what you have input 2 Add a patient If you want to add or more new patients you can click Add after the patient information has been input Each new patient wills a different patient NO If you want to test the patient s sample just change the present sample No into the patient No 3 Select print mode In this part seven print modes are provided General Liver function Kidney function CK enzymes Lipids Iron and Electrolytes General Print all item tested in the test order Liver function If this mode i
28. s selected 18 items are included 1 ALB TP GLB ALB GLB T BILI D BILI Oo 29 7 IBILI 8 AST 9 ALT 10 AST ALT 11 GGT 12 ALP 13 LDH 14 LDH AST 15 GGT AST 16 TBA 17 PALB 18 GLU Kidney function If this mode is selected 6 items are included 1 UREA CR UA TP ALB GLU Oo A CK enzymes If this mode is selected 4 items are included 1 CK 2 CK MB 3 AST 4 LDH Lipids If this mode is selected 8 items are included CHOL TRIG HDL C HDL C ApoA ApoB ApoA ApoB ApoE pue DUE des Iron If this mode is selected 2 items are included 1 IRON 2 TIBC Electrolytes If this mode is selected 11 items are included 1 2 30 Cl Ca Mg Zn GLU AMS LPS O ON Input patient NO which need to be printed patient NO can be input as following 1 1 2 3 4 3 6 1 5 1 4 5 6 3 4 5 7 If all patients need be selected you can select the check box select all Click Print the report will be printed If some item in the mode hasn t been tested there will have no correspondent data in the report 4 Input no chemistry item Setting Directly inputting a no chemistry item and result is also permitted this item will be printed in the General mode report In the window of By patient click setting a window will be open as Screen 5 2 Test name Unit Normal low and Normal high are all nee
29. sult the reagent manufacturer for information on the concentrations of heavy metals and other toxic constituents in each reagent Biohazardous parts Avoid direct contact with the sipper tubing and all parts of the sample flow path Treat these areas as potentially biohazardous and or infectious Reagents Avoid direct body contact with reagents Direct body contact may result in irritation or damage to your skin Refer to the manufacturer s reagent kit box and package inserts product information sheets for specific instructions Avoid direct body contact with cleaning solution Direct body contact amy result in skin irritation or damage Refer to the manufacturer s kit box and package inserts or product information sheets for specific instructions ATTENTION Cautions Require for Samples and Reagents calibrators and controls BGT s Semi auto Chemistry Analyzer is a Reagent open system But before the testing the following items should be noted first Generally all the reagent and samples have to be stored and prepared as per the manufactures instructions BGT BioGenTechnologies GmbH do recommend that these reagents should from the manufactures with valid product quality certificate and production permission legalized by local government or from the valid distributors appointed by BGT BioGenTechnologies GmbH in your country Before your test please check the following Check the expiration date of the material Check i
30. sured The process and result of the measurement will be displayed 2 Instruction window X Aspirating Standard Repeat Follow the instruction of the instruction window 3 The result will be displayed on the result window and the standard curve will be displayed in same time User can save and print the result UA Calibration Endpoint Non linear 0 0 30 0 g L Screen 3 2 3 5 List calibration Select Calibration list in Main menu to list the calibrations The list screen will be displayed Please select Screen 3 3 1 Select the test which one will be checked Click 25 2 The result of the test will displayed the screen Abs 10 000 7000 0 000 p 000 0 000 p 000 gt o OC Xi 0 0004 10 000 30 00 Screen 3 4 3 Print the result by selecting the Print 4 Select Exit to go back to the above menu 26 Chapter 4 Control 4 1 General The control program gives the possibility of storage and statistical evaluation of controls measured on the instrument For all 130 tests programmed in the unit 2 controls can be defined The result of controls for 130 tests of 365 days could be stored automatically 3 operating should be performed for the controls e Program controls e Measurement of controls e Lis
31. t statistics 4 2 Program controls The control parameters could be programmed in the menu parameter modify see the screen 2 15 The setting was described in 2 4 3 4 3 Measurement of controls A control can be run at any time during a test run after the test has been calibrated Select Controls in menu of test procedure a window will be open as following End point 21 16 58 57 Contro pus Reagent blank 7 0 0004 QC Cal Print Change no Clear OK Cancel Cancel 0 300 Screen 4 1 Control 2 Flowcell 340 Sample 1 5 Uhnit sec 1 Choice 1 if only measuring 1 control and choice 2 if 2 controls will be measured Select Enter to confirm the choice 2 Instruction window will display Control 7 Hold the control requested by analyzer under the sample tube and press Sample button The programmed volume will be aspirated and measured The process and result of the measurement will be displayed 3 he result wil be added to the statistical memories automatically The evaluation of control results can be accessed through the main menu and described in 4 4 4 4 List controls Select Control in main menu to list the statistics of controls The list screen will 27 be displayed Select month Quality contral list Screen 4 2 1 Select the test and the month will be checked Click Enter 2 The statistic of the contr
32. ve Input the number by clicking the window number This parameter determines how many standards with the same concentration will be used for calibration Possible inputs are 1 2 and 3 The results of multiple measurements will be averaged by the system Select OK to confirm the selecting Select Exit to go back to above menu 2 4 4 Control parameter Select Control for programming control The follow window will appear 19 UATest parameter E Control 2 Ave Batch Unit Temperatu Main wave Sub waveh fa Blank Control Cancel Screen 2 13 Controls setting menu a Control 1 and control 2 Two controls could be defined 0 Mean value Input the mean value of the control c Minimum Input the minimum of the control d Batch number The different batches of a control will have different values Enter the batch number e Select OK to confirm the programming Select Exit to go back the above menu without modifies 2 4 5 Selecting a Mode Enter the menu of the Programming screen 2 13 click Change mode A window will be pop up CliChemH Screen 2 14 Measurement mode menus Select Yes the following screen appears Please select tesk mode End point Kinetics Screen 2 15 Change mode menus a Endpoint After a required incubation time the reaction reaches its maximum color development
33. yboard 1 2 3 Rear view Figure 1 5 Power Switch 2 3 4 5 6 Brightness 7 Lan 8 USB 12 9 SD Card 10 5 232 interface 11 Drain Port 1 2 4 Flow cell and cuvette The following sketches will help you locate and identify the flow cell parts Figure 1 6 1 2 5 Lamp and sipper pump 1 Remove the lamp cover and flow cell cover 2 The sketches of the lamp and the sipper pump are as show in the following figure1 7 1 8 ATTENTION Cautions The source lamp becomes extremely hot during operation never touch the lamp when it is on Look directly the light path of the lamp may cause eyes damage too If the lamp needs to be changed always switch off the lamp by switching off the instrument and then wait until the lamp has cooled down Adjust screw LAMP Holder Light sourse block Figure 1 7 13 1 8 lip button Adjustment screw Chp bar jenerator 14 Chapter 2 Operating Procedures 2 1 Powering on Turn the instrument on using the power switch on the rear panel The screen will display the following Semi auto Chemistry Analyzer BioGenTechnologies CliChemH Version 5 0 2 Lite Copyright 2002 BGT BioGenTechnologies GmbH All Rights Reserved Screen 2 1 System initialization The instrument will be waiting the lamp stable in 2 minutes Then the screen will d
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