CliChemPlus Semi-auto Chemistry Analyzer User`s Manual
Contents
1. e Take off the light source bracket change a new one put as the original way and rotate screw 2 tightly Connect the power source connecting line of the light source unit well e Make the spiral images in the middle of the seam of monochromator through lens by slightly regulate the position of light source with screw 1 and 2 3 4 Simple trouble disposal Trouble Shooting 1 Analyzer can not be started Check whether the instrument is switched on Check whether the power plug is loosen Check the fuse Check the power supply 2 The lamp is not lighted Check power supply before changing bulbs If the lamp is damaged change lamp 3 Printer can not be started Check whether the power plug is loosened Check ON OFF button of printer Check the fuse of printer 4 Printer can not print Check whether it is normally connected 5 There is no fluid in the Flow Cell Check whether peristaltic pump is normally running Check the connection 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 Cell is very dirty 43 CliChemPlus User s Manual 6 There is no reading on the photometer 7 The Deviation of water blank is too big 8 The result reproducibility is low 9 The aspiration volume of Flow2. e Thermostatic bath e Flow Cell bracket e Flow Cell Support board for light source Aspiration tube CliChemPlus User s Manual Figure 1 5 Flow Cell 1 6 6 Source light and peristaltic pump e Light source module Open the upper cover of instrument light source module is at the back of grating system and composed of light source lamp bracket of light source light source socket and lens Light source Light source sock bracket lens Screw 1 Screw 2 Figure 1 6 Light source module e Peristaltic pump system Peristaltic pump system consists peristaltic pump generator peristaltic pump installation board peristaltic pump and pump tube Peristaltic pump is installed on the outside of the board behind the instrument and it s easy to change the peristaltic pump tube CliChemPlus User s Manual Peristaltic pump head dad Y Fixing block o T y a Adjustment Pump tube k ye 2 S screw i y E pl V i i i Mein y ee AL AX SX ANd ee ak AS d os x a 1 VR Pg m d EKA Kf pet lv eee Ul Mi Pump generator Ly L Pump installation board Water outlet Figure 1 7 Peristaltic pump system 1 6 7 Principle structure figure Only for reference Keyboard Optic and AID colorimetric Computer LCD display transform Printer Figure 1 8 Principle structure figure 16 CliChemPlus User s Manual 2 Operation 2
3. Cell not stable 10 Quality control out of target value range Check whether the lamp of photometer is lighted Try another wavelength to read Flow Cell is not inserted to the bottom Clean Flow Cell Change new distilled water Check the lamp of photometer There are bubbles inside the Flow Cell and it should be washed Check the aspiration condition of Flow Cell The amount of reagent is too little and the volume should be increased Change the lamp of photometer Reaction fluid is polluted The aspiration tube has been inserted too deep into the Flow Cell pull it out slightly Check whether aspiration tube is blocked Peristaltic pump tube should be changed 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 the Flow Cell use another reagent or quality control to test again 44 CliChemPlus User s Manual 4 Appendix Data backup and serial interface data transmission Data backup function can be used to perform data parameter export and import and the data also can be exported from serial interface Click data backup button in the main menu enter data backup window as figure 4 1 Export and Import MEisior Recut Ii History Result Import Seria
4. E E E E 39 2 1 AO UU Tm 40 2 8 goo ee ed ee ol 40 3 PO Cz A A DRITTE EET 41 3 1 OVER a a an 41 3 2 clean ANS CU Ia T T TT Um UT 41 3 2 1 Clean the surface of instrument 41 3 2 2 Clean Flow Cell iii 41 O20 Instrument maintenance 42 391 Change US ecrne sos exeunt seda N OEE E aunt adum S M UE 42 3 3 2 Adjustment of peristaltic pump tube 42 3 3 3 Change aspiration tube VV 42 3 3 4 Change of light source lampes 43 3 4 Simple trouble disposal ss 43 4 Appendix Data backup and serial interface data transmission 45 4 1 WI zo DORE a ee 45 4 2 DAS OO TTE A 45 4 3 Serial interface transmission csseee IIR 45 CliChemPlus 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 CliChemPlus 1 1 3 Product features e Windows system software platform e thas two test modes of single wavelength and double wavelength e Rotate plane grating spectroscopic system and the wavelength can be continuously adjusted within the test range e Following test methods can be provided endpoint method End Point Kinetics method Kinetics Two points method Two Points Double wavelength determination Dichromatic Absorbance determination Absorbance Multi calibration curve method Multi Calibration e Reagent open or close selectable according to the user s requests e t can print synthetic
5. is easy to produce bubbles and cause inaccuracy of test result 1 6 Main structure 1 6 1 Front view Figure 1 2 Front view Indicating lamp 1 State indicating lamp Indicating lamp 2 State indicating lamp Paper feeding button Internal printer moves paper outward Rinse key Start or stop the rinsing of instrument channels Aspiration tube When the instrument work is in Flow Cell mode press aspiration key and the sample is aspirated through aspiration tube to the Flow Cell CliChemPlus User s Manual Aspiration key Press aspiration key when the figure indicates aspiration the instrument will automatically aspirate the sample into Flow Cell Instrument labeling LCD screen Display the interfaces Printer cover The installation position of printing paper in internal printer 1 6 2 Keyboard and mouse CliChemPlus can connect USB mouse and USB Keyboard 1 6 3 Back view Figure 1 3 Back view Fan Power switch Ethernet interface CRT interface USB interface SD card socket COM interface Peristaltic pump Adjusting screw of screen brightness CliChemPlus User s Manual 1 6 4 Internal printer CliChemPlus Semi auto Chemistry Analyzer can be equipped with professional internal temperature sensitive printer When internal printer is used select Internal printer in the System Setting Mode 1 6 5 Flow Cell Open the upper cover the internal part of colorimetric system includes
6. perform test operation according to the indications 340 nm Ambient 10 30 47 6 Sec Centro 1 Figure 2 19 Quality control test 27 CliChemPlus User s Manual 2 3 3 Two points method test Test principle Two points method test is a special example of kinetics method test i e when absorbance value begins to change linearly measure the difference of absorbance of two points in the linear section compare with the calibration results thus obtains the concentration of reaction solution by calculation Select a two points method item from test item list click OK button and system will enter the two points method test mode as figure 340 nm Ambient 15 07 26 6 Sec Distiled water Figure 2 20 Two points method test This item can test water blank reagent blank and sample test e During the test procedure quality control test and standard test can be inserted at any time The number of test sample will be added automatically and the sample number can be changed by user at any time e When the test result exceeds the range of linear test system can warn and indicate e Click Print button test results and curve chart can be printed Click Back button system returns to the upper menu 2 3 4 Kinetics test Test principle Kinetics method refers to use photometer to continuously detect the absorbance value of reaction fluid after mixing reagents and sample When absorbance value
7. read The unit is second Read time Test time participated in the calculation The unit is second Reading time of endpoint method is fixed to be 1 second and no setup is needed Press Result button in the parameter setting window perform setup to the related parameters of test results As figure 2 6 Decimal 1 Linearity limit Reference Figure 2 6 Result parameters setting e Unit There are 10 fixing units to select In addition 5 units can be defined by users in the system setting menu refer to section 2 5 1 e Decimal The number of digitals that the result reserving behind decimals e Linearity error Only for item setting of Kinetics method e Linearity limit Set the linear upper limit of item test results e Reference range Set the normal range of item test results There are five functional buttons under the parameter setting window they are Standard Control Save Print and Result e f the item needs to set the parameter of calibration standard click Standard button perform setup to the corresponding parameter in standard parameter setting window Figure 2 7 20 CliChemPlus User s Manual Mo af std ji Repeat tires Calculation method Linear C Non linear Standard concentration 1 25 2 2 n S amp l 7 Figure 2 7 Standard parameter setting v No of std Input the number of calibration standard When non linear fitting calcul
8. report test parameter reaction curve calibration curve and quality control data figure etc 1 2 Product property 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 routine biochemical indexes of other body fluids CliChemPlus User s Manual 1 4 Instrument specifications Differentiation rate 0 001Abs Display 0 0001 Abs Internal calculation Light source Halogen tungsten lamp Wavelength 330 800nm continuously adjusted Temperature control Ambient temperature 25 30 37 Flow Cell Flow Cell Interface RS 232 bidirectional communication and USB interface etc Display Liquid crystal display Print Internal printer or external printer Work environment O 40 relative humidity lt 85 Storage environment 10 40 relative humiditys85 Weight 10kg Overall dimensions 3 0mm L x284mm W x318mm H Mains input a c 110V 220V 11V 22V 50Hz 60Hz Power input 80VA Fuse pattern 05x20 Fuse rated value 3 15AL250V 1 5 Instrument installation 1 5 1 Instrument Opening and Sealing 1 Unpack the instrument package and remove the materials used in the transportation Please preserve the packing box and materials well and its convenient for you to repack the instrument someday in the future 2 Take the instrument out of the plastic package 3 Acc
9. should not be upended at any time The symbol means that the level piled up can t exceed 8 layers as not to damage instrument The symbol indicates temperature range of the analyzers during storage and transportation CliChemPlus 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 tool
10. 1 Power on Open CliChemPlus power switch indicating light 2 is on and the system begins to load The picture is as following CliChem Plus Chemistry Analyzer Loading s Loading system parameters Figure 2 1 system loading After finishing loading and system initialization enter main menu as figure 2 2 CliChemPlus User s Manual o BGT BioGenTechnologies CliChem Plus Chemistry Analyzer SN Common ser Start sample testing Power Off y Figure 2 2 main menu The administration software of CliChemPlus Semi auto Chemistry Analyzer has five function modules of test setting test result searching system setting and user identify The function of all the modules and the operative methods refer to the following sections Note In order to ensure the normal startup of instrument please don t switch the power on immediately after turning off the power supply The interval between power on and off should be more than 30 seconds 2 2 Test setting It includes Test setting and Non chemistry Setting Only administrator can edit item parameters Refer to section 2 6 User identify 2 2 1 Edit Biochemical item The test parameters of each item of CliChemPlus can be edited by users Select Test Setting in the main menu system will enter item selection window as figure 2 3 CliChemPlus User s Manual Figure 2 3 Item selection window After selecting the item to be edited click OK button t
11. CliChemPlus 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 Rev 1 2e CliChemPlus User s Manual How to use this manual Its greatly appreciated you become the user of CliChemPlus 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 CliChemPlus Semi auto Chemistry Analyzer of BGT BioGenTechnologies 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 ltalics 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 CliChem
12. Empty volume Regulate the time of system emptying after each sample test The bigger the empty amount is the longer the time is The default value is 800 Pump factor When the aspirate volume of system has deviation the deviation can be eliminated by revising the calibration factors of peristaltic pump Calibration method When the aspirate volume is smaller than expected increase the calibration factors of peristaltic pump On the contrary reduce it 37 CliChemPlus User s Manual System correct Blank scan Change date Typical 10 wavelength User defined Start san hm End pan nm Interval Delay 25 5 Figure 2 38 System maintenance 2 Typical 10 wavelengths Select this item the system will scan the 10 default wavelengths 340 380 405 450 492 510 546 578 620 and 670nm User defined Scan according to the appointed scanning wave band and scanning intervals e Blank scan Click scan button after selecting the scanning mode the system will perform scan to the water blank value of each wavelength automatically and the scanning results are to be displayed in the list Click print button and users can print the scanning results Note Before the blank scanning please ensure the Flow Cell or Cuvette is full of distilled water or other things to be tested System correct Blank scan Pump replacing date 2006 12 B Lamp replacing date 2006 12 n Save Figure 2 39 Sy
13. Plus User s Manual Symbols on the instrument Symbols on the instrument gt gt Cn ac IVD 5 E E 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 scalded The symbol is labeled on the lamp support of optic system This means that the labeled 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 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 part where the instrument contacts the clinical reagent The symbol appears in black side and yellow background oymbols on the sales packaging 4 l 1r ii d 4r JL Tr yL 3r L J r L The symbol means that the environment of instruments must be dampproof in the course of transport and instrument must be kept in a dry environment This means that instrument should handle with care in the course of transportation so as not to damage it The symbol means the instrument packaged
14. 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 e Glassware cleaning liquid or dilute hydrochloric acid 0 1N Tween 20 dilution 2 3 drops L is used to clean flow Flow Cell Press RINSE key aspirate cleaning liquid press RINSE key again to stop the rotation of peristaltic pump make cleaning liquid 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 conditions The deviation of water blank is too big e Change test items Before power off Warning Don t leave the reaction fluid or other pollutants in the Flow Cell for a long time 41 CliChemPlus User s Manual 3 3 Instrument maintenance 3 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 250V 3 15A Consumers are suggested to use voltage regulated power supply Warning Must use the fuse of the specifications above When fuse is changed forbid to operate with electricity 3 3 2 Adjustment of peristaltic pump tube After the instrument is used for a long time the position of peristaltic pump can be adjusted The methods are Rotate the lock catch of pe
15. User s Manual e Click Back button and turn back to item selection window 2 2 2 Settings of calculated items At the item select window click Calculate button it will enter the window of calculated item settings as the below figure Item Decimal Reference GLE ALB GLB IBILI AST ALT c Ln LDH amp ST GGT AST amp poA ApoB EC 1 EC 1 iim E EE 1 Figure 2 9 Settings of calculated items Select the item which needs to be calculated set the parameters of decimals and reference range click Save Note Only when the calculated items have been selected it will print out the test results of these items Otherwise they will not be printed 2 2 3 Non chemical item editing CliChemPlus can setup 15 non chemical items This function is provided for the users to add non chemical item test results to the samples existed in the system so as to implement the function of printing synthetic reports Select Non chemistry Setting in the main menu the system will enter Non chemistry test setting window as figure 2 10 22 CliChemPlus User s Manual No Test Quanj Unit Reference 4 Figure 2 10 Non chemistry test selecting window As to the 15 items in the list users can select any item of them according to the requirement click Edit button to enter editing window and input the item name item result quality qualitative or quantitative result reference val
16. and external print modes When internal print mode is selected users have to appoint whether instant print is needed When external print mode is chosen the printer type needs to be selected 36 CliChemPlus User s Manual System temperature The left lower corner of the menu displays the real time temperature of the system Touch panel Perform calibration of touch panel optional function 2 5 2 System maintenance In system setup menu click Maintenance button to enter system maintenance window as figure 2 37 System correct Change date Termperature Temperat v D C Pump speed Empty volume Temperature factor D Pump factor Figure 2 37 System maintenance 1 Temperature set the system temperature ambient temperature 25 30 or 37 can be selected Current temperature Display the current temperature on real time of the system Temperature factor If the real temperature of system is not in accordance with target temperature users can perform adjustment Adjustment method If the real temperature is lower than the target temperature increase the amount adjustment of temperature On the contrary reduce the amount of adjustment of temperature The inputting range of temperature adjustment is from 2 0 to2 0 Pump speed Regulate the rotation speed of peristaltic pump while aspirate fluid There are 1 to 8 kinds of methods from slow to quick The default value is 6 e
17. ation method is used the number of standard preparations should be 3 at least Only one standard number of two points method is permitted v Repeat times As to each standard preparation all of them can perform multiple measurement of district mean while doing calibration test and the repeating time is allowed to be 1 to 3 v Calculation method When sample concentration and absorbance meet the linear relation straight line fitting should be selected Otherwise non linear fitting is chosen and a kind of calculation method among poly line fitting cubic curve fitting logarithmic fitting and indexing fitting should be selected v Standard concentration The inputting of standard preparation concentration should meet the progressive order from low to high If the item needs to set quality control preparation parameters click Control button The parameter of item quality control preparation can be set in quality control setting window Figure 2 8 as well as select the rules of losing control Control 1 Control Control 3 Target E SD bs ha p Lot Rule of losing contral M 1 value exceeds 35D 5 consecutive values below 250 on the same side consecutive values exeed AVG on the same side Figure 2 8 Quality control parameters setting Click Save key to save the revised parameter If all the parameters of the selected item needs to be printed click print button 21 CliChemPlus
18. begins linear changes measure its changing ratio and the concentration of reaction solution is obtained by calculation according to Lambert Beer Law Select a Kinetics method item from test item list click OK button and the system will enter the mode of Kinetics method test as figure 28 CliChemPlus User s Manual actot 1000 000 340 nm Ambient 15 08 27 J 6 Sec istilled water Figure 2 21 Kinetics method test This item can test water blank reagent blank and sample test During the test procedure quality control test can be inserted Kinetics test dose not need calibration test e The number of test sample will be added automatically and the sample number can be changed by user at any time Any data interval can be selected to calculate again The test results are not linear when it exceeds linear error or linear test range system can warn and indicate e Click Print button test results and curve chart can be printed Click Back button after indicating washing system return to the upper menu Note e When the test results of Kinetics method occur non linear exceeding linear error range or exceeding linear test range system can warn and indicate At the moment users can apply corresponding treatments according to the requirements e When Kinetics method appears non linear test results users can calculate again according to the fixed data intervals of reaction curve 2 4 Testre
19. can be changed by user according to the requirements at any time Click Print button it can print test result and curve charts Click Back button the system will indicate the following information figure 2 13 and then turn back to the previous menu CliChem Plus Figure 2 13 Rinsing indication 2 3 2 Endpoint method test Test principle After mixing the reagent and sample reaction reaches the endpoint after some time i e color or absorbance of reaction solution do not change any longer at this time measure the absorbance value of reaction solution concentration of reaction solution can be obtained according to Lambert Beer Law CliChemPlus provides Dual 24 CliChemPlus User s Manual wavelength test method to some of test items in this way some interference factor can be erased Users can perform Dual wavelength setup according to the requirements of reagent instructions Select an endpoint method item from the test item list click OK button system will enter the menu of endpoint method test As figure 2 14 340 nm Ambient 15 05 28 6 Sec Distilec water Figure2 14 endpoint method test It can perform water blank reagent blank sample blank and sample test ltems needed reagent blank test system will automatically save the reagent blank value of the last test and inquire the user whether retest reagent blank while entering the test interface Select No and con
20. igure 2 42 power off ensuring Click Yes the system will close automatically Click No it will turn back It will indicate users to wash the tubes before power off As figure 2 43 Ls Please prepare flushing liquor then press aspirate key Figure 2 43 Rinsing before power off Prepare the rinse solution about 4mL according to the indication of figure 2 40 press aspiration key Turn off the power supply after finishing washing according to the indications 40 CliChemPlus User s Manual 3 Maintenance 3 1 Overview CliChemPlus Semi auto Chemistry Analyzer is a clinical precise analyzer and daily maintenance work must be well done to keep the instrument in good condition 3 2 Clean instrument 3 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 Warning Please don t let any solvent lip and erosive material touch the instrument 3 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 Flow Cell must be placed according to the requirements refer to Chapter 1 e If the exterior of Flow Cell is polluted soft cloth with dehydrated alcohol can be used to slightly wipe it 2 Clean the inside of Flow Cell Put the container with distilled water under the aspiration tube press
21. l transfer Baund rate Parity Stop bit 15200 v Even 1 Select data Today Figure 4 1 Data transmission 4 1 Data export Select history data QC data Standard data or All data in data backup module and then click Export key The corresponding data can be backuped to SD card All data includes history data patient data standard data quality control data biochemical item parameters and non biochemical item parameters 4 2 Data import Select History Result quality control data Standard data or All data in data input module and then click Import key to backup to the corresponding data input system in SD card Import can be performed only the data to be imported exists in SD card 4 3 Serial interface transmission The current or total sample test data can be transmitted from COM1 to the appointed receiving devices by serial interface transmission function Use RS232 serial interface cable to connect COM1 of CliChemPlus and the devices to receive data start and set up the software parameters of the receiving devices Select the corresponding setup parameters of serial interface and data to be transmitted in the transmission module of serial interface and then click transmit to send the selected data to the receiving devices Data format R Name Department Sex Age Sample no Test Result Unit Checksum 45 R FINISHED CliChemPlus U
22. lts to exited patient record click Add button to enter the menu as the following figure Mon chemistry test 1 WBC Qualitative result Quantitative result 1 Figure 2 30 Add non biochemical items Select non chemical items in the pull down list input the corresponding results and then click Save to add a non chemical item record to the current patient 33 CliChemPlus User s Manual Note Only administrator can revise the test result common users can not revise Print by items Figure 2 31 Item report window In By item window select the date and select the items to be printed click Print key Print the result reports of the selected items in the appointed date Print history records 2006 12 B Select all Figure 2 32 History record window Select the date in History record window and all the history records of the corresponding date will be displayed in the list Select one or more records in the list and then click Delete or Print Selecting Select all means to select all the records in the list e Click Clear all to delete all the history records in the system 34 CliChemPlus User s Manual Note In order to ensure the check efficiency of software please clear the old history records in time Print order In the Printer order window as figure 2 33 select any item and then click Up or Down keys to change the printing order of items in the
23. o enter parameter setting menu as figure 2 4 Re End point Two pont kinetics Test T Full name Temperature ambient Sample val Fo o Wavelength 1 B40 Reagent val Bo o Wavelength 2 po Aspirate vol S500 Blank EUR Delay timels 5 Factor foo Read tires IE 3l Figure 2 4 parameter setting menu Test method Users can select test methods according to reagent instructions Endpoint Two points or Kinetics according to the reagent instructions as well as editing the test parameters When item test method is to be changed the system will indicate the following information CliChem Plus Figure 2 5 Change test mode 19 CliChemPlus User s Manual Temperature Select 25 C 30 C 37 C and ambient temperature to test Wavelength Input the needed wavelength within 330 800nm Dual wavelength test is only applicable to endpoint method item If secondary wavelength is not needed to set please input 999 in the wavelength 2 column Reagent blank It can be selected e Blank type It is only for endpoint method item Sample blank reagent blank or none can be selected Factor It is able to be get by calibration test or input according to the reagent instructions e Sample vol reagent vol and aspirate vol The unit is uL and the recommended aspirate vol is 500ml e Delay time It needs a period of time for the sample to be stable after being aspirated into Flow Cell and then begin to
24. ording to the packing list confirm the following stuffs should be included in the package e CliChemPlus Semi auto Chemistry Analyzer e Users manual CliChemPlus User s Manual e Packing list e Warranty certificate e Power line e QC certificate 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 proper position In order to ensure the normal work of instrument please select the working places that meet the following requirements to put CliChemPlus Semi auto Chemistry Analyzer e Working table without direct sunshine e The surface of working table is flat space is enough and there is no big shake e g hydro extractor e No electromagnetic device that produces magnetic field around e Places without extreme changes of temperature e Places without lots of dust Attention The work environment of instrument is that temperature is between 0 40 and relative humidity is below 85 1 5 3 Power source requirement e a c 110V 220V 11V 22V e 50HZ 60HZ e 80VA 1 5 4 Connect instrument to power source Insert the two ends of power line in the instrument outlet and alternating current outlet respectively Warning Alternating current power must be well earthed Alternating current power must be stable It is prohibited to use power source with high power equipments together and it s better to equip with vol
25. 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 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 CliChemPlus User s Manual Content How to use this manual 2 Symbols on the WIS ross 1 de descente 3 Warning and Safety Indications 4 a es at 6 Le Brief introduction of instrument 8 1 1 Prod IntrodulellOlI races re enter eee e tee TUM RUFEN un 8 1 1 1 Product name Semi auto Chemistry Analyzer 8 11 2 Model CHODCMPIUS 2 ananas ae POI DIS dx Gd CURE ERR d 8 1 13 JPVOGUCTTSAIUIES nn re aan tan pb ere armee e rac att bad ev a aia 8 1 2 Product property structure and composition seesessss 8 1 3 F POGEICE AD DIGADIILY a a 8 1 4 Instrument SDECINICALONS cacscssesonsicsstonntantdensianedcanteneseaniantdetadensdecatoannias 9 1 9 Instrument installation 9 1 5 1 Instrument Opening and Sealing Vs 9 1 5 2 Select proper position sis 10 1 5 3 Power source requirement cccceccecceeeeecceeteeeeeeceeceteeeeeeseetseseeeeeesaees 10 1 5 4 Connect instrument to power source 10 1 5 5 Connect external printer 11 1 6 Install FloWGellicsisscicueicciet a a Y ERE Cr cua re d
26. report Click Initial key the print order will return to the default setting i e arrange by letter order Figure 2 33 Print order 2 5 System setup 2 5 1 System parameter setup Select System Setting in the main menu system will enter system setup window As figure 2 34 ch 123456789 Hospital name fo hospital Date 006 y j2 m E d Time l5 Po Ps Figure 2 34 System setting 1 35 CliChemPlus User s Manual System Mode Printer Internal printer Instant print C External printer Epson Stylus Cod Colorimetry mode Flowcell Cuvvete System Mode Unit User defined unit mg d ural L Figure 2 36 System setting 3 System setup includes the following setup items SN SN is the serial number of machine this information setup is not opened to the users Hospital name Input the name of the hospital using the instrument this information will be printed in the report title as hospital name Date and time Display the current time of system users can revise and correct it User defined unit CliChemPlus allows users to define 5 units according to the requirements besides 10 fixing units Revise the user defined units the unit selections during biochemical item parameters editing will change too Colorimetric mode When cuvette is needed to perform test please select Cuvette otherwise select Flow Cell mode Printer CliChemPlus provides internal print
27. ristaltic pump tube clockwise and open the backplate of pump tube e Take off the peristaltic pump tube 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 Warning f the pump tube is not installed well the instrument will not aspirate 3 3 3 Change aspiration tube If aspiration tube or flow Flow Cell is blocked by miscellaneous objects syringe can be used to clean and dredge If the damage or block of aspiration tube is serious you can change an aspiration tube The methods are e Pull flow Flow Cell out e 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 figure 3 1 e Fix the fixing tube to the entrance of flow Flow Cell 42 CliChemPlus User s Manual Aspiration tube N Fixing tube Figure 3 1 Aspiration tube connector at the entrance of flow Flow Cell 3 3 4 Change of light source lamp Please cut off the instrument power supply before changing lamp Pull out the connecting line of the light support power supply and rotate out the screw 1 and 2 on the light source bracket refer to figure 1 7 Light source module
28. rs and test reports However they can t revise the biochemical item test parameters and the patient test results The identity of this kind of users do not need passwords system approves the user identity as common user in default condition Administrator Administrator also can change the biochemical item test parameters and test results besides all the operation competences of common users and they can enter system maintenance function module The identity of this user needs password the primary password of system is 888888 and administrator can change the passwords according to their requirement For the reliability of test results it is suggested to keep the password of administrator secret 39 CliChemPlus User s Manual In user identify window users can select the login identity administrator or common user identity At the same time the password of administrator can be revised Both selecting administrator identity and revising administrator password need to input the password of administrator 2 7 About Click BGT icon in the main menu the picture of system version information occurs as figure 2 41 BGT BioGenTechnologies CliChem Chemistry Analyzer V 1 0e Beta Front Version 0 BGT BioGenTechnologies GmbH http www biogentechnologies de Figure 2 41 About 2 8 Power off Click Power off button in the main menu the affirmative picture of power off occurs as figure F
29. s and spare parts should be used After finishing the operation please use disinfecting liquid soap to wash hands Otherwise the parts 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 Power voltage connection and earthing Be sure not to insert the plug into the electrical outlet of alternating 4 CliChemPlus User s Manual current over 220v Otherwise it may cause fire or electrical shock e 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
30. ser s Manual 46
31. stem maintenance 3 38 CliChemPlus User s Manual e Changing date of pump tube Record the date of changing pump tubes at the last time system will judge whether it is needed to indicate users to replace a new one according to this The period of changing pump tube is 3 months and the system will indicate while it is expired e Changing date of lamp Record the date of changing lamps at the last time system will judge whether it is needed to indicate users to replace a new one according to this The period of changing lamps is 6 months and the system will indicate while it is expired Note System setup window is only open to the administration user After changing the pump tubes or lamps please renew the changing date so as to ensure the indication of system is correct 2 6 User identify Select User identify in the main menu system will enter identity setup window as figure 2 40 User identify C User select Administrator Ra Password ja Mew password Figure 2 40 User identify CliChemPlus sets different operation authorization to users with different identities This kind of administration mode of competence grading can meet the control of users on the validity of system test results The introductions of all the identities and passwords are as following Common users Common users can apply instruments to perform routine tests edit the basic information of patients and check and print all the paramete
32. sult searching 2 4 4 Standard searching Select Calibration in the main menu system enters item selection window Select the needed items from the list click OK button and system enters Calibration menu as figure 2 22 29 CliChemPlus User s Manual Calibration Data Calibration Curve Conc U L ABS A Figure 2 22 Check calibration data Calibration Data Calibration Curve Linear Figure 2 23 Check calibration curve Figure 2 22 and figure 2 23 are the calibration data and curve of item TP respectively Click Print button calibration data and curve can be printed 2 4 2 Quality control search Select QC result in the main menu system enters item selection window Select the needed items from the list click OK button and system enters QC Result picture as figure 2 24 ALB QC Result Month Dec 7 C Control 2 Control 3 Figure 2 24 Data checkup of quality control 30 CliChemPlus User s Manual Select quality control preparation and months in the window displayed in the figure above corresponding quality control data will be displayed in the list Click Curve to check the quality control chart as figure ALB lan Figure 2 25 Quality control chart Figure 2 23 is the test results of quality control of item ALB in September Click Print button to perform the print of quality control results Click Clear button to clear the appointed resul
33. tage regulated power supply If there is smoke abnormal smell or strange sound of instrument cut off the power at once and contact with the distributor CliChemPlus User s Manual When power line is inserted or pulled out you must hold plug itself not the power line 1 5 5 Connect external printer 1 Ensure both the printer and instrument is power off 2 Insert one end of USB connecting cable into the USB interface socket of printer 3 Insert the other end of USB connecting cable into the USB port of instrument 4 Use the power line equipped with the printer to connect the printer and alternating power supply 1 5 6 Install Flow Cell Figure 1 1 Open the upper cover 1 Just as the above figure push away the upper cover of the instrument after unscrewing the hand rotating screw fixing the upper cover 2 Take off the adhesive tape used to fix Flow Cell and take off the wrapping materials 3 Put Flow Cell in the thermostatic bath pay attention to make the light hole direction the same with that of the light path CliChemPlus User s Manual 4 Make the aspiration tube go through the fixing hole in the instrument and let it extend forward 5 Install the upper cover again and rotate the screw tightly Warning Don t touch the light hole of Flow Cell so as to avoid the lipid on the hands affecting the transmittancy of Flow Cell Make sure not to press and bend along the aspiration tube otherwise fluid flow
34. the test results in the system e Select one or more patients click Print button system will print the test report of corresponding patient if all the records in the list need to be chosen please select select all otherwise please don t select Patient information editing Click Edit button in the window of figure 2 27 enter patient information edit window as figure 2 28 Date 2006 4 24 Sample na Mame ack Sex Male Age FE Sender Smith Dept ud Figure 2 28 Patient information edit window Input sample number and other patient information and then click Save If the record 32 CliChemPlus User s Manual of this patient is existed renew the patient records or add a new patient record Note e Different patients must be marked by different sample number in the same date e In order to ensure the check efficiency of software please clear the old patient records in time Review and editing of patient test results Select a piece of patient records in the list of figure 2 26 and then click View to enter the following menu The corresponding test records of the current patient will be displayed in the list as figure Sample 1 Date 2006 4 24 Figure 2 29 Patient test item Editing e Ifthe test results need to be revised select the test records first Input the results in the corresponding compiling frame below the list and then click Revise If need to add non chemical item test resu
35. tinue to use the current value of reagent blank During the test procedure quality control test and standard test can be inserted at any time The number of test sample will be added automatically and the sample number can be changed by user at any time When the test result exceeds the range of linear test system can warn and indicate Click Print button test results and curve chart can be printed Click Back button after indicating washing system return to the previous menu e Standard test According to the different parameter settings standard test of different methods are performed before the sample test refer to section 3 2 1 In the test menu click Standard button standard selection window will appear as figure 29 CliChemPlus User s Manual Select standard Concentration ABS 000 Standard 1 Esp Standard 2 Standard 3 Standard 4 Standard 5 Standard amp Standard 7 Standard 8 Figure 2 15 Standard selection window Select the standard preparation to be tested according to the standard parameter setting 8 standard preparations can be chosen at the most click OK Standard test information appears in the indication column of the test menu as figure 2 16 perform test operation according to the indications 340 nm Ambient 10 31 47 6 Sec Std 1 25 200 U ml Repeat 1 Figure 2 16 Standard test Finish calibration test and the system
36. ts of quality control 2 4 3 Report print Select report print in the main menu system will enter the following window ETE By test History Print order Figure 2 26 Report print Users can select three kinds of printing methods By patient print by patient e By test print by test e History print the history records e Print order Specify the print order of items in synthetic report of patient Print by patients 31 CliChemPlus User s Manual 2006 12 5 Report style General Select all Glearup histroy patients Figure 2 27 Patient report window Select date all the patient records of the selected date will be displayed in the list and following operations can be performed e Click Edit button to Edit the basic information of patient e Select a patient click check button to enter patient item editing menu and test items of patient can be edited add revise and delete the biochemical items and non biochemical item results of corresponding patients e Select one or more patients click Delete button system will delete all the test results and patient records of the selected patients if all the records in the list need to be chosen please select select all otherwise please don t select e Click Clear history patients button it will delete all the patient records and
37. ue and unit qualitative items have no unit As figure 2 11 Test WEC O Qualitative reference Quantitative reference 14 n 25 Unit ann Figure 2 11 Non chemistry test setting window 2 3 Item test After finishing the parameter setup of item test users can perform item test at once Select Test in the main menu system will enter item selection window After selecting the item to be tested in the list click OK button to enter the test menu The current colorimetric mode Flow Cell or Cuvette mode is indicated on the right upper corner of the test menu and it can be revised during the system setup e If Flow Cell test mode is selected please prepare the sample to be tested according to the indication column and press aspiration key to aspirate samples e If Cuvette mode is applied please place the Cuvette according to the indication column and then press aspiration key to start reading Under the mode of Cuvette aspiration key only controls the start of reading not the start of peristaltic pump 23 CliChemPlus User s Manual 2 3 1 Absorbance test Select ABS in the test item list system will enter the absorbance test menu As figure 2 12 Ambient 15 02 34 6 Sec Distiled water Figure 2 12 Absorbance test It can perform water blank reagent blank sample blank and sample absorbance test e The number of tested sample is added automatically and the sample number
38. us ver pna i i E ii bI RE 11 1 6 IO SIC TU fC SERRE ER RE DUS Penta E CURE ePLeUPLRUREPLE E UI UPUES 12 LOT LR PRRENETN Eom 12 1 0 2 Keyboard and MOUSE diebus nn ent ces Guen eee bn a capas 13 16 3 BACK VIEW PR 13 164 Internal OVI Rae snaar aan 14 UIS FOV Cel esan E E AE A 14 1 6 6 Source light and peristaltic pump ceecceececeeeeeeeeeeeeseeeseeeeaeeesaees 15 1 6 7 Principle structure figure Only for reference 16 2 Oo reii o 17 2 PONS OT ee ce ee m 17 2 2 ug E 18 2 2 1 Edit Biochemical ILetTi sissssssu revivre ax chers neo EPI PERS prf REP Rd EE NC rS a irl ui 18 2 2 2 Settings of calculated items 22 2 2 3 Non chemical item editing Rs 22 Lo OE S a aamuamacnaaseuanaaniads 23 29e ADSOrDaANCE lOS Co asieetes rena ined qd EE UE UI RITE RUPPUE 24 2 9 2 Endpoint method TESTS t n pum sequ hue Dg ux mus xbox s mts 24 CliChemPlus User s Manual 2 39 9 Two points method TOST ssi usn ete ne een MIN ane a E o I n WR DEUEES 28 2A iic M 28 2 4 Test Tesult SC AC ses ess crise rte ses ctss een 29 2 4 1 Standard searching 29 240 2 Quali control S ANCES en tpese nd a n es 30 22 9 REPON DIM PE Sun Satu tau En Sec tb D Nu EE EE 31 Ze SOS CD 35 2 5 1 System parameter setup ie 35 2 5 2 System maintenance i 2 dec are biens eee 37 2 6 Stile ae
39. will display new calibration result as figure Mew factor 0 000 Figure 2 17 New calibration result 26 CliChemPlus User s Manual If the calibration test results of this time need to be saved click Save button system will automatically renew the calibration data of this item Otherwise click Give up button system will continue to use the old calibration data Note Correct calibration result is the important premise of the accurate result of sample test On the precondition of not changing reagent and no changes of machine environment calibration test is not necessary to be performed everyday e Quality control test Quality control test can perform effective monitoring to the current accuracy of the system When the results of quality control test are abnormal users have to check the current condition of system Quality control test can be performed at any time In the test menu click Control button quality control selection window will appear as figure 2 18 Control 1 Control 2 Control 3 Target 24 600 Target 56 200 Target 0 000 S0 0 300 S0 0 600 S0 0 000 Batch 612001 Batch 612002 Batch Figure 2 18 Quality control selection Select the quality control preparations to be tested according to the quality control parameter setting 3 quality control preparations can be chosen at the most click OK Quality control test information appears in the indication column of test menu figure 2 19
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