SACA-19600
Contents
1. 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 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 27 SACA 19600 User s Manual 340 nm Ambient 15 08 27 6 Sec a 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 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 t2. 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 value and unit qualitative items have no unit As figure 2 11 Test WEC Qualitative reference Quantitative reference 14 EM 25 Unit kion 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 If Cuvette mode is applied please place the Cuvette according to the indication column and then press aspiration key to start reading e Under the mode of Cuvette aspiration key only controls the start of reading not the start of peristaltic pump 22 SACA 19600 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 12 340 nm Ambi
3. Laboratory Equipment Manufacturer AN www mrclab com CE iNet CC THE NTEPINATTONAL CERTIFICATION NETWORK INSTRUCTION MANUAL FOR SACA 19600 Semi auto Chemistry Analyzer PLEASE READ THIS MANUAL CAREFULLY BEFORE OPERATION 3 Hagavish st Israel 58817 Tel 972 3 5595252 Fax 972 3 5594529 mrc mrclab com MRC VER 01 1 11 9600 User s Manual How to use this manual Its greatly appreciated you become the user of 9600 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 9600 Semi auto Chemistry Analyzer of 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
4. 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 43 9600 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 A History Result m History Result Serial transfer Baund rate Parity Stop bit 19200 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
5. difference SACA 19600 User s Manual Symbols on the instrument Symbols on the instrument g EI P P 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 IE He 4r r 1r i E E du J L JIL 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 pac
6. 2 7 Mo af std Repeat tires il Calculation methad Linear C Non linear Standard concentration e en ee Figure 2 7 Standard parameter setting v No of std Input the number of calibration standard When non linear fitting calculation 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 Y 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 Controli Control Control 3 Target Rule af losing control v 1 value exceeds 35D v 5 consecutive values below 25D on the same side 7 consecutive
7. 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 read The unit is second e 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 Unit JIL Linearity error jis wo 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 Decimal The number of digitals that the result reserving behind decimals Linearity error Only for item setting of Kinetics method Linearity limit Set the linear upper limit of item test results 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 19 SACA 19600 User s Manual button perform setup to the corresponding parameter in standard parameter setting window Figure
8. figure 2 16 perform test operation according to the indications 34D nm Ambient 10 31 47 6 Sec Sta 1 25 200 U ml Repeat 1 Figure 2 16 Standard test Finish calibration test and the system will display new calibration result as figure Mew factor 0 000 Figure 2 17 New calibration result 25 SACA 19600 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 S00 300 Sp u eut Sp Batch 612001 Batch 612002 Batch Figure 2 18 Quality control selection Select the quality control preparations to be tested according to the
9. preserve the packing box and materials well and it s convenient for you to repack the instrument someday in the future 2 Take the instrument out of the plastic package 3 According to the packing list confirm the following stuffs should be included in the package SACA 19600 Semi auto Chemistry Analyzer User s manual Packing list Warranty certificate Power line QC certificate SACA 19600 User s Manual 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 SACA 19600 Semi auto Chemistry Analyzer e Working table without direct sunshine e he 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 C 40 C and relative humidity is below 85 1 5 3 Power source requirement e a c 110V 220V 411V 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
10. ssesesseeesseeseeereeren 21 2 2 3 Non chemical item editing seeeseeseeseeereernennnn en 21 PS El m 22 2 9 1 JADSOIDaDIGO TOS asieran ninia a oestas pla mg oc emad es cu tea es HRS 23 2 9 2 Endpoint method fest uoeuieas ducc sous t n gums sese nailer Duque eux min rexbon mns 23 SACA 19600 User s Manual 2 39 9 Two points method OST cosecucib inpet po cenecepciese ners dt CMM SUR DE YE ia 27 ZS KNEUS eSlus a a a hada a aa a aaa iA 27 2 4 Test result SCORCHING ncecocarcssececceneceecestesececoniescecanieeceeandsonegontsenieenesenceesate 28 2 4 1 Standard SCArCHING cccceccceccceeeceeecceeceeeeesueeseeeceueesesesseetseeeseeseeeeaees 28 240 2 Quality control search sioaciccs cee ctheceaszciadecenaeilanaddaaceseuauieanecieetGatouuaestadwale 29 22009 REDO DNI aseesinaine uut tanda dt uiuat ndUU ATENA 30 PE OIM TT 34 2 5 1 System parameter setup cccccccccecccseeceeeeceeeeeseeeeeeseeeceeeesneeseeeseeeesaes 34 2 5 2 System maintenance uisi oen ape Dunes tea sulu est eu psmnUrcl uin taps ie od dU RR ape de 36 2 6 Stile ie E E E E 38 2 1 PAO OU MN RETE UT 39 2 8 goo eee A A E RENE A EE eee eee 39 3 ilz Tg is E SA E e E pice TRITT ETT TOT 40 3 1 S RU ETENIM 40 3 2 clean ANS CUA T TT UT 40 3 2 1 Clean the surface of INStrUMENT ccc cccccsececeeeceeeeceeeeeeeeaeeeseeesaeeeaes 40 3 2 2
11. 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 results of quality control 2 4 3 Report print Select report print in the main menu system will enter the following window By patient By test History Figure 2 26 Report print Users can select three kinds of printing methods e By patient print by patient 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 30 9600 User s Manual 2006 12 5 Report style General Select all Clearup 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
12. Clean Flow Cell seesseesseesssesseeenenen enne nnne nnnm nnne nnn nnns 40 939 Instrument MAINTENANCE sssssssssesseseeeneennn nennen nnns 41 391 Change SO es nse ESE tusedh utat ipiis badusa a MU EE 41 3 3 2 Adjustment of peristaltic pump tube ssseseeeeeeeeenee 41 3 3 39 Change aspiration tube seeeseesssessseeereenennnen nennen nnns 41 3 3 4 Change of light source lamp seeeeeeseeenennnnnmenenn 42 3 4 Sl mbiedroliblediSDOSAl ss musuqui morsu PUVUNEUPHEUHECURDEUUOFE Ua FUEEUDI UE UU UU PE US EME 42 4 Appendix Data backup and serial interface data transmission 44 4 1 WI 0o NET TEE 44 4 2 WIziEz IFO OU RETE TOTUM 44 4 3 Serial interface transmission ccceccecccceccceccacececcccccccaceceaceusueaesneas 44 SACA 19600 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 SACA 19600 1 1 3 Product features e Windows system software platform e It has 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 deter
13. 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 COM 1 to the appointed receiving devices by serial interface transmission function Use RS232 serial interface cable to connect COM1 of 9600 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 R FINISHED 44
14. d Water outlet Figure 1 7 Peristaltic pump system 15 SACA 19600 User s Manual 1 6 7 Principle structure figure Only for reference Keyboard Optic and AID colorimetric Computer LCD display system transform Printer Figure 1 8 Principle structure figure 16 SACA 19600 User s Manual 2 Operation 2 1 Power on Open SACA 19600 power switch indicating light 2 is on and the system begins to load The picture is as following Chemistry Analyzer Loading N Loading system parameters EN Figure 2 1 system loading After finishing loading and system initialization enter main menu as figure 2 2 Chemistry Analyzer SM Common Usar Start sample testing p Figure 2 2 main menu The administration software of SACA 19600 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 SACA 19600 User s Manual 2 2 1 Edit Biochemical item The te
15. e aspirate fluid There are 1 to 8 kinds of methods from slow to quick The default value is 6 e 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 e 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 36 9600 User s Manual System correct Blank scan Change date i Typical 10 wavelength User defined Start san Aim End n nm Interval Delay 2 5 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 replaci
16. eeeeeeeseeseeeeseeees 9 1 5 1 Instrument Opening and Sealing eeseeeeeeseeeeeeeeeee 9 1 5 2 Select proper position cccccceccseeceeeceeeseeeseeesereeeteeeeeeeeeeeeetseeneeeaeeees 10 1 5 3 Power source requirement seeseesessssssssseneennen nennen nnn nnns 10 1 5 4 Connect instrument to power source seseseeseeeenenennennee 10 1 5 5 Connect external printer cccccccceeeeecceeeceeeeeeceeeseeeseeeeseteeeneeeeaeteeenees 11 1 6 Install FloWGellissscicuesect iade vx pep a MUERE Cr cL dre d vert aS ue iode a 11 1 6 Vile Ia zs B UO ir A TET TERN 12 1 0 1 FON VIOW couecsezisdaiaaekemte n RBRUM RERUM Ux E Der aura utri aU Vd SIDE x E RT Rud eS tl 12 1 0 2 Keyboard and MOUSE isse cabe o aeta t pena etai uma mud eer eas a a capas 13 16 3 BACK RET 13 164 Internal printer costosa PEU S Eexhdicus euMPPIU REPE UDINE Head dE PERIERUNT SSDREUN IE 13 UI FOV GCel nen nee eee eee ee ee ee ee ene eee 14 1 6 6 Source light and peristaltic DUMP cc eccccccceeceaeeeceeeeaeeeceeeseeeeaeesaees 15 1 6 7 Principle structure figure Only for reference esseeseesss 16 2 reii o i P E EEE 17 Z1 miei deg RR 17 2 2 go E 17 2 2 1 Edit Biochemical item iius re ravori ene Rare ras PE PERS pr eR Rd Kk Ra rS a rl ui 18 2 2 2 Settings of calculated items
17. ems 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 continue 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 24 SACA 19600 User s Manual Select standard Concentration ABS UO Standard 1 55 29 0 Standard 2 Standard 3 Standard 4 Standard 5 Standard 6 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
18. ent 15 02 34 0 6 Sec Distiled water Figure 2 12 Absorbance test t can perform water blank reagent blank sample blank and sample absorbance test The number of tested sample is added automatically and the sample number can be changed by user according to the requirements at any time e 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 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 SACA 19600 provides Dual 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 23 SACA 19600 User s Manual 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 29 6 Sec Distilec water Figure2 14 endpoint method test It can perform water blank reagent blank sample blank and sample test It
19. ette otherwise select Flow Cell mode Printer 9600 provides internal print 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 35 9600 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 Blank scan Change date Temperature Temperat v O 0 0 Pump speed Empty volume Pump factor eoo Temperature factor o ji Figure 2 37 System maintenance 1 Temperature set the system temperature ambient temperature 25 C 30 C or 37 C 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 C to 2 0 Pump speed Regulate the rotation speed of peristaltic pump whil
20. f 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 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 Sym Made unit ch 123456789 Hospital name fo hospital Data 2006 Time Figure 2 34 System setting 1 34 9600 User s Manual Internal printer Instant print External printer System Mode Unit User defined unit 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 9600 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 Cuv
21. he 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 SACA 19600 User s Manual Content How to use this manual sseesessesseseeseenee nennen nnne 2 Symbols on the WISTS ross sce ce oooo ee rmt Pea bad an Re ee ses ne StbsE reedescds 3 Warning and Safety Indications eeeseeseeeeeeeeeenenn 4 Sigilli H 9 6 i Brief introduction of instrument eeeseeeeeseeeeee 8 1 1 FFOGUGE INGFOGUCTION cacssacrsaemaancaraccesnaceearanncnnsereccnnnuniesssneyeratheananahinaaasaas 8 1 1 1 Product name Semi auto Chemistry Analyzer sssssse 8 1 1 2 Model SAC Be GOO cts poses ss tedo na atum dut saan ancecaiencotdmansersesatnueuiee ses 8 1 13 Product tealuleS snena E EEE ERES 8 1 2 Product property structure and composition seeeesses 8 1 3 miejeBre ieoe i 8 1 4 Instrument specifications wcce carscssesonsicsstonntantdencianedcanseneseaniantdetadensieaatsnaaiins 9 1 5 Instrument INStAIATION cece cece cece eeseeceeseeseeceseececees
22. kaged 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 SACA 19600 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
23. low 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 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 D Indicating lamp 1 State indicating lamp 2 Indicating lamp 2 State indicating lamp 3 Paper feeding button Internal printer moves paper outward 4 Rinse key Start or stop the rinsing of instrument channels 5 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 6 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 9 Printer cover The installation position of printing paper in internal printer 12 SACA 19600 User s Manual 1 6 2 Keyboard and mouse SACA 19600 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 amp 69 C 3 5 CO 1 6 4 Internal printer SACA 19600 Semi auto Chemistry Analyzer can be equipped with professional internal tempe
24. mination Absorbance Multi calibration curve method Multi Calibration e Reagent open or close selectable according to the user s requests e t can print synthetic 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 SACA 19600 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 C 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 0 C 40 C relative humiditys85 Storage environment 10 C 40 C relative humiditys85 Weight 10kg Overall dimensions 3 0mm L x284mm W x318mm H Mains input a c 110V 220Vx11V 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
25. mp 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 4 9600 User s Manual Aspiration tube lt gt 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 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 monochroma
26. ng date 2006 12 B Lamp replacing date 2006 12 n Save Figure 2 39 System maintenance 3 37 9600 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 identity C Wser select Administrator SN Password ja sh Mew password Figure 2 40 User identify 9600 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
27. o 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 Testresult 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 28 9600 User s Manual Calibration Data Calibration Curve Conc LL 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 O Control 2 O Control 3 SD Hint Figure 2 24 Data checkup of quality control 29 9600 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 Jan Figure 2 25 Quality control chart Figure 2
28. 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 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 i Mame ack Sex Male Age EE 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 3 9600 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 jn 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
29. ops 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 40 9600 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 peristaltic 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 Install the pu
30. or 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 29 9600 User s Manual 3 Maintenance 3 1 Overview 9600 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 f 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 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 Glassware cleaning liquid or dilute hydrochloric acid 0 1N Tween 20 dilution 2 3 dr
31. 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 voltage 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 When power line is inserted or pulled out you must hold plug itself not the power line 10 SACA 19600 User s Manual 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 Just as the above figure push away the upper cover of the instrument after unscrewing the hand rotating screw fixing the upper cover Take off the adhesive tape used to fix Flow Cell and take off the wrapping materials Put Flow Cell in the thermostatic bath pay attention to make the light hole direction the same with that of the light path Make the aspiration tube go through the fixing hole in the instrument and let it extend forward Install the upper cover again and rotate the screw tightly 11 SACA 19600 User s Manual Warning Don t touch the light hole of F
32. quality control parameter setting 3 quality control preparations can be chosen at the most click OR Quality control test information appears in the indication column of test menu figure 2 19 perform test operation according to the indications 340 nm Ambient 10 30 47 O 6 Sec Centro 1 Figure 2 19 Quality control test 26 SACA 19600 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 e Click Back button system returns to the upper menu
33. rature sensitive printer When internal printer is used select Internal printer in the System Setting Mode 13 SACA 19600 User s Manual 1 6 5 Flow Cell Open the upper cover the internal part of colorimetric system includes Thermostatic bath Flow Cell bracket Flow Cell Support board for light source Aspiration tube A M Figure 1 5 Flow Cell 14 SACA 19600 User s Manual 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 DEUS lens bracket 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 Peristaltic pump head dd Fixing block A MJ Adjustment Pump tube Y X i N Fa screw Lt E tu 3 F A y Pal 4 h M i pom t r3 dk L t 1 a 1 a LEN a r AC y F t J Fh af od I F IM a oe QUE V r F pU 4 s a T pm m A T a y i F p Pump generator yy AL Pump installation boar
34. st parameters of each item of SACA 19600 can be edited by users Select Test Setting in the main menu system will enter item selection window as figure 2 3 Figure 2 3 Item selection window After selecting the item to be edited click OK button to enter parameter setting menu as figure 2 4 Ne End point D Two point Kinetics Test fave Full name Temperature Ambient Sample vol 50 Wavelength 1 340 Reagent vol 500 Wavelength 2 ps9 Aspirate wol 500 Blank Blank Delay tirnets b Factor 1000 Read tires p 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 18 SACA 19600 User s Manual Do you want to change test moder Figure 2 5 Change test mode e Temperature Select 25 C 30 C 37 C and ambient temperature to test Wavelength Input the needed wavelength within 330 800nm e 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 e Factor It is able to be get by calibration test or input
35. 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 results to exited patient record click Add button to enter the menu as the following figure Non chemistry test fa WBC r Qualitative result Quantitative result EE 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 32 9600 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 3 Select all Figure 2 32 History record window e 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 33 9600 User s Manual Note In order to ensure the check efficiency o
36. tests edit the basic information of patients and check and print all the parameters 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 e 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 38 SACA 19600 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 Power off Click Power off button in the main menu the affirmative picture of power off occurs as figure Figure 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 liqu
37. tools 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 SACA 19600 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 e Be sure not to damage the isolation protection peel of power line Don not pull t
38. tor 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 lf 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 42 9600 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 Flow 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
39. values exeed AWG on the same side Figure 2 8 Quality control parameters setting 20 SACA 19600 User s Manual e Click Save key to save the revised parameter e lf all the parameters of the selected item needs to be printed click print button 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 GLB ALB GLB IBILI AST ALT c Ln LDH AST GGT AST amp poA ApoB E D D 2 D D D 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 SACA 19600 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 21 SACA 19600 User s Manual No Test Quanj Unit Reference 4 Figure 2 10 Non chemistry test selecting window
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