CliChemFLC Semi-auto Chemistry Analyzer User's Manual
Contents
1. 12 Test time Input the reaction time of the test procedure endpoint method does not need this parameter 13 Decimal Digits The reserved digit after the decimal point of result The maximum is 4 14 Aspirate volume The aspirated solution amount of peristaltic pump This parameter indicates the amount of imbibed fluid to be tested each time In order to ensure the accuracy of test aspirate volume is generally more than 400uL General items should set as 500uL the aspirate volume of reagents with great pollution can be increased to 7OOUL After setting all the parameters press ENTER key to automatically save parameters and return to the menu of item parameters confirmation press ESC key to return without saving Therefore correct standard parameters must be inputted Note Generally the aspirate volume of 500uL can ensure the cross contamination ratio below 1 The aspirate volume can be 25 CliChemFLC User s Manual increased or reduced and it is concretely regulated by the number input on keyboard 2 5 1 4 Standard settings At the menu of parameters confirmation select STD press ENTER key to enter the settings menu of standard parameter according to the indications as figure 2 11 Method The calculation methods of standard test are linear regression and non linear regression respectively Choose by lt P key No of Std The number of standard preparations used in the standard test process The maximum is 8 to2. 41 Instrument maintenance elssssesessseeseeenneeeenn nennen nnns 42 5 34 Change fuses seis E ee tedesca 42 5 3 2 Adjustment of peristaltic pump tube sssssssseeenene 42 5 3 3 Change of aspiration tube sssssssssssseeeennee 42 Simple trouble shooting tet tne eet es eeh adeeb ae eel ase coe epe oue Dec oce Dept 43 CliChemFLC User s Manual 1 Brief introduction of instrument 1 1 Product introduction 1 1 1 Product name Semi auto Chemistry Analyzer 1 1 2 Model CliChemFLC 1 1 3 Product features e Monochrome LCD English menus e It has two test modes of single wavelength and double wavelength e Following test methods can be provided Endpoint method Endpoint Fixed time method Fixed time Kinetics method Kinetics Double wavelength Dichromatic Absorbance Absorbance Multi calibration curve Multi Calibration e It can perform sample analysis of serum plasma whole blood and urine etc e Open for reagent and there is no specific restriction Internal printer can print English reports and programming parameters etc 1 2 Product structure and composition It is composed of optical system pipeline system computer control system and software etc 1 3 Product applicability It is for the clinical tests of body blood and the tests of all kinds of general biochemical criterion of other body fluids CliChemFLC User s Manual 1 4 Instrument
3. Power source must be cut off when connect the peripheral equipments Otherwise it may cause electrical shock or troubles Specifications of Pharmaceutical affairs law It is forbidden to refit the medical instruments CliChemFLC User s Manual Content How to use this manual essere nnns 2 Signals used on the packing box eessssseeeeeeeeeee 3 Warning and Safety Indications cceeccececeeeeeeeeeeeaeeeeeeeeeeaeneees 4 1 Brief introduction of instrument sseeseeeeeesesse 8 1 1 SRO CCTM AUC LIOR S auod cute dequo ad im alk es ark ane balk emo ds teme ot Oa 8 1 1 1 Productnaam 2c eee mated Nae odie 8 1 1 2 Modelismo ete e te hte ete 8 1 1 3 Product a ete Ola e ET No e iiie 8 1 2 Product structure and composition cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeenaes 8 1 3 Produc applicability serenan a a a a Dr Un Doer ex eR eR 8 1 4 Instrument specifications cnet ortae tot rra eere ht ee e doc totereeeto 9 1 5 drisirumient InstallstibET rodeo bus is npo proche a pce nte ub 10 1 5 1 Instrument Opening and Sealing sssssseeeee 10 1 5 2 Select proper position for the instrument sssesssssssse 10 1 5 3 Power supply requirement 10 1 5 4 Connect instrument to power supply sssseeeee 11 1 5 5 Install flow cell sssseseen men 11 1 6 Main Structure oo OE EHE ERPUU HIE
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5. no reading on the photometer Check whether the bulb of photometer is lighted Try another wavelengh to read Flow Flow cell is not inserted to the bottom 6 The difference value of water blank is too big Clean flow cell Change new distilled water Check the bulb of photometer 43 CliChemFLC User s Manual 7 The result reproducibility is low There are bubbles inside the flow cell and it should be washed Check the aspiration condition of flow cell The usage amount of reagent is too little and the dosage should be increased Change the bulb of photometer Reaction fluid is polluted tThe insertion of aspiration tube in the flow cell is relatively deep and pulls it out slightly 8 The aspirate volume of flow Flow cell is not constant Check whether aspiration tube is blocked Peristaltic pump tube may be changed 9 Quality control is not within the target value range Check the valid date of reagent Check whether the settings are correct and whether it need revise parameters Make sure quality control is not polluted Measure again with other methods Check flow flow cell and use the other reagent and quality control to measure again Note Instruments of different versions may have slight changes All these changes are performed on the premise of not affecting the functions and operation of instrument consumers can take
6. of item parameters confirmation as shown in figure 2 9 Press lt P Key to select QC STD Edit and Ok press Enter to enter corresponding programs ALT Kinet mg dL 37 C 340 No Reag 1746 0 500 3 30 60 60 00 20 00 QC STD Edit Ok Figure 2 9 Menu of parameters confirmation The meaning of each parameter is as following 1 row Item name Test method Unit Temperature 2 row First Second wavelength Blank type Factor Aspirate vol Decimal digits 3 row Delay Time Test Time Norms high Norms Low 4 row QC settings Standard settings Parameter settings Enter test menu Press lt P Key to switch between QC STD Edit and OK press Enter Key to enter corresponding programs 2 5 1 3 Item parameters editing At the menu of parameters confirmation select Edit press ENTER key and the parameter setting of corresponding item will be performed as figure 2 10 Item Name ALT Norms High 1000 00 Method Kinetics Norms Low 200 00 Unit umol L Delay Time 30 Temperature 37 C Test Time 60 First Wavelength 340 Decimal Digits 3 Second Wavelength None Aspirate Vol ul 500 Blank Reagent Factor 1746 0 Figure 2 10 Parameter editing menus 23 CliChemFLC User s Manual Basic operation method 1 2 Select the item which needs to be edited moving cursor by press on the keyboard the selected item will be highlighted to display To edit the settings As to t
7. of skin that contact with blood may be infected electrically injured or burned Extremely be careful while dealing with samples Rubber gloves must be put on or it may cause infection If the sample enters into eyes or wounds use a great amount of water to wash at once and accept the checkup of doctors Reagent Application If the reagent enters into eyes use a great amount of water to wash at once and accept the checkup of doctors If drink the reagent at error turn to the doctors immediately and take a lot of water to vomit the reagent at the same time If hand or skin is stained with the reagent clear with water at once The used tubes and other instruments should be properly disposed as the medical wastes or infective wastes If the person is stained with blood there is possibility of being infected by pathogens CliChemFLC User s Manual Power voltage connection and earthing Be sure not to insert the plug into the electrical outlet of alternating current over 220V Otherwise it may cause fire or electrical shock When the instrument is installed three core power cable accompanied with the machine must be used and ensure it is well earthing Otherwise it may cause fire or electrical shock Be sure not to damage the isolation protection peel of power line Don not pull the power line with exertion or hang heavy things on it Otherwise it may cause broken circuit or short circuit thus lead to electrical shock or fire
8. to wash the tubes after tests Consumers can directly cut off the power supply on the premise of ensuring the tubes are not needed to be washed It is suggested to wash the tubes before exit 2 3 How to operate the software The number in front of the item name is in accordance with the number key on the keypad it means the serial number as well as the key number of the corresponding operation For example in the main menu if you press number key 1 in the keypad system will enter test menu XP on the right side of the name means to use the left and right keys on Keyboard to change the settings of parameters In the menu refers to use the up and down keys on Keyboard to select the concrete menu item 2 4 System settings System parameter is used to set the most basic parameters of the instrument e g date and time etc Press key 3 and enter the menu of system settings As figure 2 3 1 Printer Settings 2 Time Settings 3 Data Transfer D 600901001 4 Optics Settings CliChemFLC User s Manual Figure 2 3 System settings menu 1 Print settings In the menu of system settings press key 1 the instrument will enter the following menu as figure 2 4 Printer Status Open Printer Select Internal Figure 2 4 Printer settings The instrument is equipped with an internal thermal sensitive printer and selects open and close by lt P key on the board At the same time whether supporting instant print can be se
9. 2 7 Optic settings 1 Check the AD value Press RINSE key to aspirate certain volume of distilled water must fill the pipeline Press left or right key lt P to switch between wavelengths and check the AD value of current wavelength 2 Save AD value Because AD value will be taken as a fiducial value for calculation it can not be saved discretionarily Only when the filters are replaced or it always prompts Retest during water blank test you need to save the AD value again First press RINSE key to aspirate distilled water must fill the pipeline press left and right key lt P to switch wavelength Then waiting for the AD value stable press ENTER Key to save the AD value of current wavelength the prompt Save will disappear 21 CliChemFLC User s Manual Note e This operation will affect the test performance so just used to determine whether to replace lamp or the redo repeated appear at water blank e Make sure enough water in flow cell at this operation aspirated by key RINSE e Press key ENTER will only store the AD value of current filter and other filters still hold the line 2 5 Sample test Sample test includes item settings and item test Item settings includes test method item name unit temperature wavelength blank delay time test time and aspirate volume range of normal reference value factor standard and quality control etc Item test is composed of blank te
10. 340 nm 405 nm 500 nm 546 nm 620 nm and none When single wavelength is used to test secondary wavelength must be set as none Choose secondary wavelength by lt P key 7 Blank Select the blank testing including none reagent blank and sample blank Choose the blank type by lt P key In the endpoint method test reagent blank and sample blank can be selected according to the consumer requirements Two points method test can choose reagent blank and kinetics method has no blank settings 8 Factor Input the calculative factors negative and positive value can be switched by lt P key The system supports direct inputting factors and determining calculative factors by system calibration standard test 9 Norms high The inputted result is the value of norms high of the judgment evidence 10 Norms low The inputted result is the value of norms low of the judgment evidence 11 Delay time Input the delay time of the test process The delay time is the time from the tested fluid entering flow cell to the start of actual test Note e In order to make the test samples balance temperature and eliminate tiny bubbles in the flow cell a certain time delay is necessary e Mostendpoint method tests time delay is 5 seconds e Kinetics method below 25 C time delay should not less than 10 seconds e Kinetics method below 30 C time delay should not less than 12 seconds e Kinetics method below 37 C time delay is no less than 15 seconds
11. CliChemFLC Semi auto Chemistry Analyzer 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 CliChemFLC User s Manual How to use this manual It s greatly appreciated you become the user of CliChemFLC Semi auto Chemistry Analyzer In order to get the best effect you must be familiar with our instruments and their functions before performing the clinical diagnostic tests This manual is the operating guidance of CliChemFLC Semi auto Chemistry Analyzer of BGT BioGenTechnologies GmbH Company which including the contents of instrument installation daily test quality control and daily maintenance etc As to the users who uses external printer please refer to the user s manual of external printer at the same time Please reserve all the packing materials for the use of deposit transportation and maintenance in the future You may contact with your distributor if there is any problem As to the instruments of different version or configuration their functions are slightly different Note Indications advices and suggestions Italics are used to differ from each other Warning Warning indications must be obeyed so as to ensure the normal operation of instruments and correct and real test results Bold face is used to make the difference CliChemFLC User s Manu
12. RO nna USADO E OCURRE DUM ens Op URGE 12 Tote EFOBEVIGW eie eene enumerat me eaae et 12 1 6 2 IKeypad ut cene eee e es be te i i ee Roe nd 13 1 6 3 Back view niee A enne E ERA EE EEK nnns E nn 14 1 6 4 Internal printer zs ceptus 14 1 6 5 Flow cell and Cuvette sessssssssssssseeee eene nnne 14 1 6 6 Lamp and peristaltic pump sssseseeHHHHH HH 16 1 6 7 Principle structure figure Only for reference ssssssssssss 17 PNEEGIe M eR 18 AXE LS aoro enc 18 2 2 Function introduction of main menu sssssssseeeseeeeee 19 2 3 How to operate the software ccccccceeecccceeeeeeeeeeeeeeeeeeeeeesseeeeeeees 19 2 4 System settings ci ire e riot tete tte tette tacet ete 19 PECES MINISTRI TT 22 2 5 1 ltem parameter settings n nn 22 AS EEE CC 28 3 1 3 2 3 3 3 4 5 1 5 2 5 3 5 4 CliChemFLC User s Manual piso MT 34 Sample FODOM oit TR 34 eM ME POUb eere 37 QC TODOPL ese otra Sete denne aavedlactentl a A E 38 Delete ROC OE ies DE 39 Power offo sen t echec eee RP ER ERN ED RC Er RE n en 40 Malritendll6 B cseceleeo di Dept cn Eau ditte meg av ricca dtes 41 COVGDVIGW eRe one Ree ee btt ott ut PL eee CRT 41 Clean iNStr men tassa nani pense Doe Sie ek ee ae ae 41 5 2 1 Clean the surface of inStrUMeNnt cece ccccccccceeeeessececeeeeeeeeeesseeeseeeees 41 b5 2 2 Glean Flow cell re test tre te Re e Ee d RE ek a 8
13. Test Standard K 1746 000 METERS EN co EE VER UE gt Test QC Test QC Test Sample Test Sample a Select single quality control b Select double quality control Figure 2 22 Quality control test selection 2 Test operation 31 CliChemFLC User s Manual After entering the process of quality control test the menu of quality control test as figure 2 23 will appear Among them Test displays the item name of current test QC shows the serial number of the current quality control solution and the corresponding quality control batch number is manifested on the right side For example Batch 070691 please ensure whether quality control preparations with same batch number are inputted before aspirating quality control solution Status displays the progress of test process and test results Aspirate please testing and save are displayed one by one in the middle down area of menu The detailed test procedure is the same with item test process please refer to the specific operation of item test Test ALT QC 1 Batch 070691 Status Aspirate Please Figure 2 23 Quality control test menu 3 Test saving After aspirating the corresponding quality control solution according to the steps system will calculate the results on real time Quality control results are displayed and quality control conditions are judged in Result column C gt 2SD means quality control result is la
14. al Signals used on the packing box Upward Dampproof Fragile Stack io HJ 3 CliChemFLC User s Manual Warning and Safety Indications This instrument is only used for in vitro diagnosis please carefully read the following warnings before the usage and strictly obeys them Warning Please carefully read the following announcements before using this instrument Cut off the power source at once if there is abnormal smells or smokes and pull out the power plug from the outlet At the moment you must immediately propose test applications to the distributors and the agents of our company If it is continuously used under this condition it may cause fire electric shock or personnel casualty Neither blood and reagent nor metal pieces of staple and pin should be dropped into the instrument otherwise it would lead to short circuit or smoke and fire If there is something abnormal cut off the power source at once and pull out the power plug from the outlet At the moment you must immediately propose test applications to the distributors and the agents of our company Operators don t touch the electric circuit inside the instrument especially wet hands which may be easier to get electric shock Rubber gloves must be put on while maintaining and checking the instrument and prescriptive tools and spare parts should be used After finishing the operation please use disinfecting liquid soap to wash hands Otherwise the parts
15. both sides deform internally and then open to the cover according to the direction of following figure 2 Internal part of colorimetric system Flow cell Thermostatic bath Aspiration key CliChemFLC User s Manual Figure 1 6 Internal part of colorimetric system e Thermostatic bath e Flow cell 3 Use cuvette system Take flow cell out of thermostatic bath Put the cuvette with samples into the thermostatic bath All the test methods are the same with those of the test of flow cell system 1 6 6 Lamp and peristaltic pump 1 Open the lamp cover 2 When changing lamps pull off the connecting line of the lamp bracket and power source rotate out the fixing screws on the lamp bracket take out the lamp bracket change a new one put it as the original way and rotate the tightening screws on the lamp bracket tightly Connect the connecting line of light bracket and power source well 3 Lamp and peristaltic pump as the following figure Adjusting screw Fixing screw Lamp bracket Fixing screw Lamp socket Lens p PE Y 6 d Figure 1 7 Light source system CliChemFLC User s Manual Peristaltic pump head EF Fixing block 7 Adjustment Pump tube screw Water inlet Pump installation board Water outlet Figure 1 8 Peristaltic pump system 1 6 7 Principle structure figure Only for reference Keyboard Optic and i AID color
16. calibrate Repeat Times The repeat times of the test of each standard preparation concentration Standard preparation concentration used in the standard test process Method Linear No of Std 1 Repeat Times 1 Concentration 133 00 Figure 2 11 Standard parameter setup menu Note e When non linear regression is selected the number of standard should be more than 3 otherwise calibrate according to the linear regression method e When more than two standards are selected the repeated number is uniformly managed according to single time e When more than three standard concentrations are inputted it must be inputted by progressive or degressive method otherwise the calibration is not successful During the treating process of standard parameter the system will indicate the third started standard concentration range as figure 2 12 The system will judge the progressive or degressive tendency automatically according to the order and the third started concentration range will be indicated at the right side Method Linear No of Std 3 Repeat Times 1 Concentration3 133 00 Con Figure 2 12 Standard concentration menu After setting all the parameters press ENTER key to automatically save parameters and 26 CliChemFLC User s Manual return to the menu of item parameters confirmation press ESC key to return without saving Therefore correct standard parameters must be inputted 2 5 1 5 QC settings A
17. ce factors can be erased This instrument provides dual wavelength test method Kinetics method Kinetics method refers to use photometer to continuously test the absorbance value of reaction fluid after mixing reagents and sample When the absorbance value begins linear changes test its variance ratio On the basis of Lambert Beer Law concentration of reaction solution can be obtained Two points method Two points method test is a special case of kinetics method test i e when absorbance value begins to change in linear measure the absorbance difference value of the two points in the linear part and thus concentration of reaction solution is obtained Unit Select the test result unit including 9 selectable units of mg dL mg L g L umol L mmol L mol L U L IU L and blank etc Choose the unit by P key Temperature Select test temperature including 4 selectable temperatures of ambient temperature 25 30 and 37 etc Choose the temperature by lt P key First wavelength Choose the test dominant wavelength according to the kit requirements including 5 selectable wavelengths of 340nm 405nm 500 nm 546 nm 24 CliChemFLC User s Manual and 620 nm Choose the dominant wavelength by lt P key 6 Second wavelength Select the test secondary wavelength according to the kit requirements and the system will flexibly implement dual wavelength method by setting secondary wavelength It includes 6 selectable secondary wavelengths of
18. d it will indicated save in the condition column of system Press ENTER key to save the calibration result and all the following item tests are calculated on the basis of this calibration result till resetting standard factors or recalibrating and saving as figure 2 21 Press ESC key to cancel the saving and directly enter item test process Meanwhile all the following item tests are calculated according to the factors before calibration If it is needed to calibrate again please select Standard Test in the test selection menu to perform calibration As figure 2 18 Test ALT STD Con 133 00 K 1746 078 b 0 012 Save Figure 2 21 standard test saving Result 2 5 2 3 Quality control test 1 Test selection In the test selection menu move cursor to Test QC and the typeface is highlighted at the moment On the right side it displays that the system can select quality control preparation and chooses by lt P key on the extreme right side System supports single quality control and double quality control select by lt P key and make the selected quality control preparation highlighted as figure 2 22 a When double quality control is chosen continuously press lt P key till two of the quality control preparations are highlighted together as figure 2 22 b Ensure the selected quality control preparation press ENTER key to enter the menu of quality control test as figure 2 23 Test Standard K 1746 000
19. ete test result and quality control respectively as Figure 3 8 Test Result Quality Control Figure 3 8 Quality control search condition Here will delete all the test results or quality control results One record can be deleted respectively as described at section 3 2 or section 3 3 39 CliChemFLC User s Manual 4 Power off After finishing all the tests turn back to the main menu press key 4 to perform the power off program When the screen displays as Figure 4 1 press ENTER key if press ESC key it will not be power off and return to the main menu Power Off Figure 4 1 Confirmation of power off When system displays as Figure 4 2 it indicates aspiration of distilled water and cleaning flow flow cell Rinse Aspirate Please Figure 4 2 Clean flow flow cell At the moment prepare enough distilled water press Aspiration key or RINSE key clean flow cell As the display of Figure 4 3 Rinsing Figure 4 3 Indication of cleaning procedure After cleaning flow cell the system displays Power off please As the display of Figure 4 4 Power off please Figure 4 4 Power off Turn off power switch 40 CliChemFLC User s Manual 5 Maintenance 5 1 Overview CliChemFLC Semi auto Chemistry Analyzer is a clinical precise analyzer and daily maintenance work must be well done to keep the instrument in a good condition The maintenance of CliChemFLC Semi auto Chemistry Analyzer is very
20. he selected item if the right side displays lt P it means to edit by lt P key If the right side displays P it indicates to enter the next editing menu by P key If the selected item has decimal point it means decimal points can be inputted otherwise only integer can be inputted Quick turning page method When the current page is ensured not to be revised directly press ENTER key to enter the next page or item test process Item parameter print In the menu of item parameter settings if parameter selection is completed press PAPER to print this item parameter Press ENTER key at the last page of item settings to automatically save the parameter settings and enter item test process Set all the parameters 1 2 Item name The system permits setting 60 test items including 47 fixed items Users can define items from 48 to 60 Method Select test method including endpoint method two points method and kinetics method Choose the method by lt P key a Endpoint method Endpoint method refers that the reaction reaches the endpoint after a period of time by mixing reagents and sample i e the color of reaction fluid will not change or the absorbance of reaction fluid will not change At the moment test the absorbance value of the reaction fluid concentration of reaction solution can be gotten according to Lambert Beer Law The kits of some test items require using dual wavelength to test and in this way some interferen
21. imetric ificati Do p Computer LCD display system Printer Figure 1 9 Principle structure figure 17 CliChemFLC User s Manual 2 Operation 2 1 Power on Open the power switch on the back of the instrument several seconds later a menu as 2 1 will appear in the screen Stabilizing temperature Figure 2 1 Temperature control After waiting the temperature control procedure for about three minutes select ESC key on the board the system will stop temperature control and directly enter the main menu of software it will enter the main menu of system As shown in figure 2 2 CliChemFLC User s Manual 1 Test 3 Sys Settings 2 Report 4 Power Off Ver1 0e 2006 11 21 16 20 08 Figure 2 2 Main menu of system 2 2 Function introduction of main menu 1 Test Edit the parameter settings calibration settings and quality control settings of the test item it will save the parameters automatically after ensuring and enter the test process to perform item test 2 Report Perform the data administration function of the test system Its functions include printing by test and patient numbers deleting the test results and searching the quality control information of the current month 3 Sys Setup Set up the basic system operations It includes printer settings power on and off time settings externally connecting administration system to transmit all the test data of the current day 4 Power off It is mainly used
22. ing items and 13 user defined items meanwhile item user definition also can be implemented directly on the basis of 47 fixing items The concrete user defined methods are as following 1 Move cursor to the Name column of parameter settings At the moment item name is highlighted or displayed as cursor symbol no item name 2 Directly input item name according to the character index figure on keyboard and the name includes 5 characters at the most During the inputting process it will automatically ascertain characters at the interval of 3 seconds and indicate inputting next character 3 During the inputting process press DEL key to delete the inputted characters 4 Set item parameters press ENTER to automatically save the user defined item name 27 CliChemFLC User s Manual and parameters and enter test process 2 5 2 ltem test After setting item parameters press ENTER key to automatically save parameter settings and enter item test process First the system will switch light filter according to the set wavelength and equip with other information The output information is as figure 2 14 The switching time is very short generally several seconds and automatically enters temperature control Switching Figure 2 14 Item switch indication After finishing item switch and information equipment the system will enter temperature control as figure 2 15 Temperature control time is set on the basis of the
23. ions e At the moment of power on the different value of water blank is too big e Change test items e Before power off 41 CliChemFLC User s Manual Warning Don t leave the reaction fluid or other pollutants in the flow cell for a long time 5 3 Instrument maintenance 5 3 1 Change fuse Fuse is installed in the fuse box beside the power switch of the back of the instrument open the box cap and it s very convenient to change the fuse Fuse specification 3 15AL250V Users are suggested to use voltage regulated power supply Warning Must use the fuse of the specifications above While the consumer is changing fuses he must ensure the power cable is pulled out Forbid to operate with electricity 5 3 2 Adjustment of peristaltic pump tube After the instrument is used for half a year the position of peristaltic pump can be adjusted The methods are e Rotate the lock catch of peristaltic pump tube clockwise and open the backplate of pump tube e Take off the peristaltic pump tube e Loose the fixing steel wire on the connecter of pump tube rotate the pump tube for 180 and then refix the steel wires e Install the pump tube well and lock rotate the lock catch of peristaltic pump counterclockwise Note If the pump tube is not installed well the instrument will not aspirate 5 3 3 Change of aspiration tube If aspiration tube or flow flow cell is blocked by miscellaneous objects syringe can be used to clea
24. lected again during the test procedure As to the detailed settings please refer to the print settings during the test procedure 2 Time settings In the menu of system settings press key 2 and the instrument will enter the following menu as figure 2 5 2006 11 09 12 15 30 Figure 2 5 Time settings Use lt P key on the board to select the item needed to be changed press Number key to change the current date or time press ENTER key to save press ESC key to turn back to the system settings menu 3 Data transfer In the menu of system settings press key 3 before this operation ensure there is communication cable inserted between the instrument and externally connected PC and serial interface of the externally connected PC is under the receiving condition the instrument will enter the following menu as figure 2 6 a While the menu of figure 2 6 b appears it indicates the data transferring is completed 20 CliChemFLC User s Manual Transfer Finish Transferring a Data transferring b Data transfer finish Figure 2 6 Data transfer 4 Optics Settings In the menu of system settings press key 4 to enter optic settings menu as shown in figure 2 7 a The wavelength X is in accordance with the installation position of corresponding filters as shown in figure 2 7 b Datum mark 340nm Wavelength2 340 a AD displaying menu b Layout of filter wheel face the installation side Figure
25. lity control results of ALT item with the batch number of 070691 on November 2006 Test Day 2006 11 ALT Item No 2 Batch No 070691 Figure 3 6 Control report search After inputting month item number and quality control batch number press ENTER key will search the records meet the conditions If no related record is searched None will be displayed at the lower right of the window as Figure 3 7 a If the related records are searched all the satisfied records will be displayed as Figure 3 7 b Result Batch Test Day 2006 11 132 098 070691 Item No 2 pat Batch No 070691 Press ENTER to print a No record b Records meet conditions Figure 3 7 Quality control search condition In the display window of searched results as Figure 3 7 b several following modes of shortcut key are defined e Page up down A single page only can display 3 records and the records of more 38 CliChemFLC User s Manual pages can be displayed by turning pages with key e Print Press ENTER key to print all the searched results e Delete Press DEL key to delete all the searched results e Return Press ESC key to turn back to the search window Note The remark in display and print report Normal condition is no display H Test result higher than 2SD L Test result lower than 2SD 3 4 Delete Record All test result and control result of the equipment can be cleared with this command or del
26. n and dredge If the damage or block of aspiration tube is serious you can change an aspiration tube The methods are Pull flow flow cell out Remove the aspiration tube at the entrance and change a new aspiration tube At one end of the new aspiration tube compass tube the middle is sheathed first and then fixing tube the thickest is sheathed Pay attention to leave 1cm outside the compass tube as the display of figure 5 1 Fixthe fixing tube to the entrance of flow flow cell 42 CliChemFLC User s Manual Aspiration emm i e Meme Figure 5 1 Aspiration tube connecter at the entrance of Flow Flow cell 5 4 Simple trouble shooting Trouble Shootin 1 Analyzer can not be started Check whether the instrument is on switch Check whether the power plug is loose Check the fuse Check the voltage 2 The lamp of photometer is not lighted Check power supply before changing lamps lf lamp is damaged change lamp 3 Internal printer can not print Check whether the plug is normally connected 4 There is no fluid in the low flow cell Check whether peristaltic pump is normally running Check the connection of the interfaces of aspiration tube and flow flow cell etc Aspiration tube is too long or too short Aspiration tube may be blocked and it should be cleared and dredged Flow Flow cell is very dirty 5 There is
27. nk as an example the procedure and related operations are introduced in details If sample blank is selected sample blank will be performed before each item test and automatically enter sample test to wait for aspirate the test sample Its operation is completely the same with that of the sample test a Confirm sample number the displayed sample number is the number of the sample to be tested and open or close online print function by gt key as figure 33 CliChemFLC User s Manual 2 25 On the condition of Aspirate please prepare the test sample press aspiration key to imbibe sample preparation System will imbibe the fluid according to the set aspirate volume and automatically enter test process Testing will be displayed in the condition column and the test progress is indicated by seconds in Status column as figure 2 26 Test ALT 10 Sample Status Figure 2 26 Sample test condition After finishing test the test results are automatically saved If this item already has the test result of the same sample number on the same day Overlapped will appear and waiting for responding Press ENTER key directly to overlap the existed result Input a new sample number then press ENTER key it will be saved as a new sample Meanwhile the sample number will increase one automatically as the number of next test sample which is provided to the consumers to revise Print the results If online pri
28. normality After testing water blank it will automatically enter reagent blank aspirate reagent according to the indications test the system and output the results After testing reagent blank no key is needed to be pressed the system will automatically enter test selection menu waiting for several seconds as figure 2 18 Cursor points to Test sample in absent condition and select by key Press ENTER key to enter the corresponding test process and press ESC key to return to this test selection menu in the corresponding test menu Test Standard K 1746 000 Test QC ICAR GE Ok Figure 2 18 Test selection menu 2 5 2 2 Standard test System is able to obtain the standard factors through two methods One is inputting factors while setting parameters at the moment K xxx will be displayed in the test selection 29 CliChemFLC User s Manual menu as figure 2 18 The other method is getting standard factors by standard test This section will introduce the basic process of standard test in details 1 Test selection Under the test selection menu move cursor to Test Standard and the typeface is highlighted at the moment System judges whether the settings of standard parameter is correct If the settings are wrong it will display None which means standard test is not needed or wrong as figure 2 19 a If the settings are correct it indicates Ok as figure 2 19 b ensure whether standard tes
29. nt function is selected open or close by gt key under the condition of waiting for imbibing fluid When the current sample test and print are completed the sample number will increase one and enter the condition of waiting for fluid aspiration of next sample test Perform according to the indications it can continuously test samples When quality control calibration or exit is needed during the test procedure press ESC key to return to the test selection menu and choose the related operations 34 CliChemFLC User s Manual 3 Report Report is mainly in charge of the test results and the quality control test of the current month Meanwhile perform the basic functions of data search print and delete etc In the main menu of system press 2 key to enter administration menu as figure 3 1 They are sample report item report and control report respectively and the corresponding function modules are entered by number key 1 2 and 3 Sample report Search the test results according to the date and sample number Item report Search the test results according to the date and item number Control report Search the quality control results according to the month item number and batch number of quality control 1 Sample Report 2 Item Report 3 QC Report 4 Delete Record Figure 3 1 Administration function selection Note CliChemFLC can save 2200 test results at the most System has data renew ability by itself When the tes
30. ower source indicating light 7 LCD 1 6 2 Keypad 4 J Ll D 3 MABC pEF AP ER eS oye ues umo POR 9 9 ao a on d Figure 1 3 Keypad Direction key Cursor moves in the screen of four SA V directions up down left and right Paper feeding key Feed paper by hand It is also the shortcut key for parameter printing RINSE Rinse key Clean the pipeline Esc l Exit key exit the menu and cancel the operation ENTER Ensure key To validate the input and save CliChemFLC User s Manual 1 6 3 Back view ABE TA 16A 2504 PUER OFF ON ACINPUT 88883 S888 O OO0000000 QOOO000000 GOOD E 880080080 838800890 88888 O o BESEF O 7 Ed LT U d Figure 1 4 Back view figure 1 Parallel port for printer 6 Fuse 2 RS 232 serial port 7 AC input 3 RS 232 serial port 8 Fan 4 Drain port 9 Backplate label 5 Power switch 10 Peristaltic pump 1 6 4 Internal printer CliChemFLC Semi auto Chemistry Analyzer has internal special temperature sensitive printer 1 6 5 Flow cell and Cuvette 1 As shown in the following figure 1 5 open the lamp cover CliChemFLC User s Manual Figure 1 5 Open the lamp cover Note While turning the light source cover open first you d better emphatically press the protuberant block of the two sides of the cover make
31. played at the lower right of the window as Figure 3 5 a If the related records are searched all the satisfied records will be displayed as Figure 3 5 b Index Result Remark From 2006 11 09 132 098 133 213 To 2006 11 09 132 098 AL T Item No 2 Press ENTER to print a No record b Condition satisfied records Figure 3 5 Item search condition In the display window of searched results as Figure 3 5 b several following modes of shortcut key are defined e Page up down A single page only can display 3 records and the records of more pages can be displayed by turning pages with V key e Print Press ENTER key to print all the searched results e Delete Press DEL key to delete all the searched results e Return Press ESC key to turn back to the search window 37 CliChemFLC User s Manual Note The remark in display and print report Normal condition is no display H Test result higher than the maximum reference value L Test result lower than the min reference value 3 3 QC report Input month item number and quality control batch number to search the results of quality control Input test date input the searched item number in item No and display the item name corresponding to the number on the right side at real time input characters in character mode switched by key Input the required quality control batch number in Batch No As Figure 3 6 It will search for the qua
32. r position for the instrument Find a place without direct sunshine in your working place The surface of the selected working table should be flat and there is enough space for placing CliChemFLC Semi auto Chemistry Analyzer The anterior edge of instrument should be near to the edge of working table Avoid comparatively large shake of working table For example put hydroextractor on the working table Note The work environment of instrument is that temperature is between 10 C 30 C and relative humidity is below 70 In order to guarantee the normal working of instrument the following places are forbidden to be put on e Places with extreme changes of temperature e Particularly hot or cold places e Places full of dust e Places nearer to the electromagnetic devices that produce magnetic field e Places with direct sunshine 1 5 3 Power supply requirement e AC110 220V 10 e 50 6041 Hz e 80VA CliChemFLC User s Manual 1 5 4 Connect instrument to power supply 1 Insert one end of the power line into the outlet of instrument 2 Insert the other end of the power line into the outlet of power supply Warning Alternating current power must be well earthed near ground voltage lt 5V Alternating current power must be stable It is prohibited to use power supply with high power equipments together and it s better to equip with voltage regulated power supply In the area with unstable voltage please use UPS powe
33. r supply to ensure the normal work of instrument When power line is pulled out you must hold plug itself not the power line If there is smoke abnormal smell or strange sound of instrument cut off the power at once and contact with the distributor 1 5 5 Install flow cell As the shown in the following figure 1 1 turn the light source cover open by hands Figure 1 1 Open lamp cover 1 Take off the adhesive tape used to fix Flow cell 2 Take off the wrapping materials 3 Putthe flow cell into thermostatic bath CliChemFLC User s Manual 4 Slightly insert the flow cell in Make the aspiration tube go through the fixing hole in the machine and let it advanced extend 5 Close the lamp cover Warning Please don t use hands to touch the surface of the light inlet window of Flow cell so as to avoid leaving the lipid of hands on the light inlet window and affecting the transmittancy Ensure the aspiration tube is in the socket otherwise it will cause pressure and bend affecting the test effects It s easy to result in inspiriting bubbles and water blank will be high 1 6 Main structure This part explains the structure of all the parts of CliChemFLC Semi auto Chemistry Analyzer 1 6 1 Front view Figure 1 2 Front view figure 1 Printer cover 2 Lamp cover Co Aspiration tube 4 Aspiration key CliChemFLC User s Manual 5 Keyboard 6 P
34. results as Figure 3 3 b several following modes of shortcut key are defined e Page up down A single page only can display 3 records and the records of more pages can be displayed by turning pages with V key e Print Press ENTER key to print all the searched results e Delete Press DEL key to delete all the searched results e Return Press ESC key to turn back to the search window Note The remark in display and print report Normal condition is no display H Test result higher than the maximum reference value L Test result lower than the min reference value 36 CliChemFLC User s Manual 3 2 Item report Input time range and item number to search the test results Input start date and end date respectively meanwhile the end date must behind the original date or the same day with the start date Input the searched item number in item No and display the item name corresponding to the number on the right side at real time Otherwise input the characters in character mode when ABC appears on the upper right side of screen Key is used to switch number and character input mode As Figure 3 4 It will search for all the results of ALT item tested on November 9 2006 From 2006 11 09 To 2006 11 09 Item No 2 A Figure 3 4 Item report search After inputting time range and item number press ENTER key will search the condition satisfied records If no related record is searched None will be dis
35. rger than the value of two SD otherwise this information will not be displayed and it is indicated save in the system condition column After ensuring quality control is effective press ENTER key to save quality control results When double quality control is selected test the two quality control preparations in order Aspirate corresponding quality control solution according to the indication and valid quality control results are saved Only one quality control result of the same item and same batch number is saved everyday as figure 2 24 Press ESC key to redo quality control After quality control test system will automatically skip to the test selection menu and point to item test as figure 2 18 QC Batch 070691 C 75 078 C gt 2SD Save Figure 2 24 Quality control test saving Result 2 5 2 4 Sample test In the test selection menu cursor points to Sample Test in absent condition and it is 32 CliChemFLC User s Manual displayed by highlight Press ENTER key to enter sample test procedure 1 Test operation When sample blank is selected during the parameter settings sample blank is performed first before sample test as figure 2 25 a When no blank or reagent blank is chosen it has already been finished during the former blank test and it will directly enter test menu as figure 2 25 b Blank and Test will display the item name of current test gt print on or gt print off on
36. simple but it must be serious and careful 5 2 Clean instrument 5 2 1 Clean the surface of instrument e Keep the clean of instrument working environment e Neutral cleaner and wet cloth can be used to clean the surface of instruments e Please use soft cloth to clean the liquid crystal display Warning Please don t let any solvent lip and erosive material touch the instrument 5 2 2 Clean Flow cell Flow cell must be kept clean so as to ensure the accuracy and reliability of the test results 1 Clean the outside of flow cell a Flow cell must be placed according to the requirements refer to 1 5 5 b If the outside of flow cell is polluted soft cloth moistened with dehydrated alcohol can be used to slightly clean 2 Clean the inside of flow cell c Put the container with distilled water under the aspiration tube press RINSE key and start the continuous washing function Press RINSE key again and washing is finished It is usually continuously washed for half a minute d Glassware cleaner or dilute hydrochloric acid 0 1N Tween 20 diluents 2 3 drops L is used to clean flow flow cell Press RINSE key aspirate cleaner press RINSE key again to stop the rotation of peristaltic pump make cleaner stay in flow cell for 5 minutes and finally use distilled water to continuously wash for 1 min If it is not cleaned after washing once cleaner can be used to wash again Flow cell must be cleaned under the following condit
37. specifications Resolution Light source Wavelength Temperature control Flow cell Interface Display Print Work environment Storage environment Weight Overall dimensions Power supply Power input Fuse type Fuse specification 0 001Abs Display 0 0001 Abs Internal calculation Halogen tungsten lamp There are 5 filters inside 340 405 500 546 620 Three more wavelengths can be added as optional Ambient temperature 25 30 37 Flow cell RS 232 bidirectional communication Liquid crystal display Internal printer 10 30 relative humiditys70 20 55 relative humiditys93 7 kg 360mm L x318mm W x160mm H AC110 220V410 50 60Hz 1Hz 80VA 05x20 3 15AL250V CliChemFLC User s Manual 1 5 Instrument installation 1 5 1 Instrument Opening and Sealing Open the instrument package and take the materials used in transportation away Preserve the packing box and materials well and it s convenient for you to repack the instrument someday in the future Take off the packing materials and take the instrument out of the plastic package Check the articles inside the package box and confirm the following should be included e CliChemFLC Semi auto Chemistry Analyzer e User s manual e Packing list e Power line Note The product accessories should be in accordance with the packing list Please contact with the distributor when the accessories are found not right 1 5 2 Select prope
38. st standard test quality control test and sample test etc 2 5 1 Item parameter settings 2 5 1 1 Select test item Figure 2 8 is the main menu of item selection the first line is status column and the following three lines indicate item name and its corresponding serial number in orders You can use direction key number key or name search to select items the details is as following 123 Index 2 1aBS PANE sast 4LDH L 5 ALP 6LDH P 7GGT 8CK NAC 9HBDH 10AMS ibAoB 12 CK MB Figure 2 8 Item selection menu 1 Select by direction key Select items by up down left and right keys the selected item will be highlighted and its corresponding number will display at the top left of the screen 2 Select by input The input methods are displayed at the top right of screen they are 123 and ABC respectively and use key to switch 123 means number input numbers can be inputted directly at the moment it will automatically select the item according to the serial number and display with highlight ABC manifests character input input the characters according to the indication of Keyboard and it will display at the middle top of screen After finishing the input 22 CliChemFLC User s Manual press ENTER key to automatically select the corresponding item if there is no corresponding item there is no response 2 5 1 2 Item parameters confirmation Select a test item press Enter Key to enter the menu
39. t data exceeds the system storage capacity system will automatically delete parts of the old data At the same time system will have the related indications during the renewing procedure Please wait for a moment it can automatically complete and start test again 3 1 Sample report Input time range and sample number to search for the test results Input start date and end date respectively meanwhile the end date must behind the original date or the same day Input the sample number to be searched in Sample No means from A number to B number and B must not be less than A at the same time When A equals to B single sample will be searched As figure 3 2 it will search the test results of sample 1 2 and 3 tested on November 9 2006 35 CliChemFLC User s Manual From 2006 11 09 To 2006 11 09 Sample No 1 3 Figure 3 2 Sample report search After inputting time range and sample number press ENTER key to search the results met the conditions If no related record is searched None will be displayed on the right down of the window as figure 3 3 a If the related record is searched all the condition satisfied records will be displayed as figure 3 3 b Index Result Remark From 2006 11 09 132 098 133 213 To 2006 11 09 132 098 Sample No 1 3 Press ENTER to print a No record b Condition satisfied records Figure 3 3 Sample search condition In the display window of searched
40. t is to be performed If it is ensured please press ENTER key to enter test procedure otherwise moving cursor to select other tests or press ESC key to return to the main menu 2 Test Standard Nane Test Standard of Test QC Test QC Test Sample Test Sample a Standard parameter has errors b Standard parameter is correct Figure 2 19 standard test selection 2 Test operation After entering standard test procedure standard test menu as figure 2 20 will appear Among them Test displays the item name of current test STD displays the serial number of current standard fluid and the corresponding concentration value is shown on the right side For example Con 133 00 please ensure whether the solution with the same concentration is inputted before aspirating standard fluid Status manifests the test process schedule and test results Aspirate please testing and save are displayed one by one in the middle down area of menu The concrete test procedure is the same with item test process please refer to the specific operation of item test Test ALT STD Con 133 00 Status Aspirate Please Figure 2 20 standard test menu 3 Test saving 30 CliChemFLC User s Manual After aspirating the corresponding standard fluid according to the steps system will calculate standard factors at real time The calibration K and b values will be displayed in the column of test result an
41. t the menu of parameters confirmation select QC press ENTER key to enter the settings menu of quality control parameters according to the indications as figure 2 13 Control The system can set two quality control preparations Select by lt P key in the settings menu of quality control parameter press lt P key to select quality control preparations in cycle Average Value Standard concentration of quality control preparation SD Standard deviation of quality control preparation Batch number Corresponding batch number of quality control Control 1 Average Value 133 0 SD 2 0 Batch Number 060791 Figure 2 13 Menu of quality control parameters After setting all the parameters press ENTER key to automatically save the parameters and return to the menu of item parameters confirmation press ESC key to return without saving Therefore correct quality control parameters must be inputted 2 5 1 6 Parameter print Under the menu of parameters confirmation or the menu of parameter settings as figure 2 9 or figure 2 10 press PAPER key to print the parameter of the current item After finishing setting all the parameters and ensuring select Ok at the menu of parameters confirmation press ENTER key to enter item test process thus it must be ensured to input the correct parameters Pressing ESC key will turn back to the item select menu 2 5 1 7 Item user definition The instrument can save 60 test items including 47 fix
42. temperature difference before and after item switch It s usually within several seconds to 3 minutes Press ESC key to cancel temperature control and enter blank test Stabilizing temperature Figure 2 15 Temperature control condition 2 5 2 1 Blank test After finishing item switch and temperature control the system automatically enters blank test process According to the settings information of parameter the system will select whether performing reagent blank When the blank settings in the parameter settings menu selects no blank or sample blank blank test will just perform water blank When reagent blank is selected blank test will perform water blank and reagent blank Item Name ALT Aspirate Please Reag Blank 28 CliChemFLC User s Manual Figure 2 16 Blank test As figure 2 16 perform water blank first and indicate Aspirate please in the column of water blank Prepare distilled water and press aspiration key the system will automatically test and output the results of water blank When the value of water blank is too big it will indicate Aspirate please Retest and the real time AD value will show below as figure 2 17 At the moment water blank must be done again If it still indicates Aspirate please Retest after many times of repeat it is suggested to check whether the light path is loosen Item Name ALT Water Blank TEICA CERS Retest Reag Blank 600 Figure 2 17 Water blank ab
43. the right upper corner of the window means to open and close the online print function by key which refers to immediately print results after finishing the test It only can be changed on the condition of waiting for aspirating fluid Sample displays the next sample number to be tested it can be changed before the test and it will indicate Change No by highlight on the right side of the corresponding column It is suggested to ensure whether the number is correct before the test otherwise the former test result will be automatically overlapped by the same item and same number Status displays the progress of test process and Result indicates the test absorbance and concentration Aspirate please Testing and Printing are displayed in order in the middle down part of the condition column please inject the sample or wait for the test according to the indications When Overlapped appears after testing it means that this item already has the test result of the same sample number on the same day Press ENTER key directly to overlap the existed result Input a new sample number then press ENTER key it will be saved as a new sample gt Print On gt Print On Blank ALT Test ALT Sample n Change No Sample nm Change No Status Status Aspirate Please Aspirate Please a Sample blank b Sample test Figure 2 25 Sample test menu 2 Test process Take no sample blank select no blank or reagent bla
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