Semi-auto Chemistry Analyzer User`s Manual SACA-19100
Contents
1.2. EditPatient Info p earch Print Setting Query TestDate 2006 12 08 x Te 2005 12 08 Sampel Wme Shezhen hospitalSample Report Sex male Age 20 year Sample id 1 Search Department shirurgery Section Area23 Sender Diagnose fever Sending Dat Full Name Result Unt Qualitve Range ALP 0 009 LYE 0 58 Table Select A alburmin 12600 000 git 50 70 f Double C A4 C Triplet C Dynamic Note Double to print double reports on the same A4 paper Print Date 2008 10 16 TestDate 2005 10 15 A4 print only one report on a A4 paper triplet print three reports on the same A4 paper dynamic punt the most reprots on a amp 4 paper Return Figure 2 17 Query print setting e Query Perform single or combined searching according to the test date sample number name and qualitative result After inputting the related search conditions click search button Switching to patient information window can check the searched results e Table select The searched results can be printed according to the four kinds of table styles Select the needed form the right side of the menu displays the table of corresponding report forms e Report print In patient information window select the needed patient click Preview Figure 2 18 and perform print If several patient reports of the total need to be printed press Ctrl key and click the patients you want to print report In the front of t
3. Laboratory Equipment Manufacturer A www mrclab com CE Net V3Net CS THE STANDARDS INSTITUTION OF ISRAEL Semi auto Chemistry Analyzer User s Manual SACA 19100 PLEASE READ THIS MANUAL CAREFULLY BEFORE OPERATION 3 Hagavish st Israel 58817 Tel 972 3 5595252 Fax 972 3 5594529 mrc 2 mrclab com MRC VER 01 10 13 User s Manual How to use this manual It s greatly appreciated you become the user of 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 Semi auto Chemistry Analyzer which including the contents of instrument installation daily test quality control and daily maintenance etc As to the users who uses external printer please refer to the user s manual of external printer at the same time Please reserve all the packing materials for the use of deposit transportation and maintenance in the future You may contact with your distributor if there is any problem As to the instruments of different version or configuration their functions are slightly different Note Indications advices and suggestions Italics are used to differ from each other Warning Warning indications must be obeyed so as to ensure the normal operation of instruments and correct and real test results Bold face is used to make the difference User s Manual Sy
4. Sampe amp w6 Insert Delete Save Close x gt Figure 2 23 Indoor quality control After inputting the content of Report Title and Item Set click Preview and the display is as the figure 2 24 33 User s Manual Print Previer E E mM 4 Report From of External Quality Assessment in Clinical Immunology Jee ees Tes Dale Conral 1 balch No ConralZ bach No Conia balkh No Conia 4 bakh No Conral5 balch No 1 Page 1 o 1 Figure 2 24 Print preview of indoor quality control Note In order to ensure the print effect of quality control it is suggested to use laser jet or ink jet printer while printing quality control chart 2 9 Calibration query In the main menu clicking Calibration Query under Management you can enter the menu of calibration curve query As figure 2 25 34 User s Manual Calibration Query Regression Linear STD Num E Repeat 1 curve beeline wo A e oT o ord 9 oe E oO o px e te e 2 D S e PN S 2 og Preview Figure 2 25 Calibration query e Item list can be selected Display the calibrated item that can be searched e Calibration curve Window After selecting items the calibration curve of this item can be displayed e Fitting mode Fitting curve and fitting straight line modes can be selected to display calibration curve e Print preview Perform the print of calib
5. 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 1 1 3 Product property The design is based on the platform of PC computer its unique information administration system can be used in the operation system of Windows 2000 XP e Open system design meets different needs of users e Rotational plane grating spectroscopic system is adopted with high precision and the wavelength can be continuously adjusted within the test range e I thastwo test modes of single wavelength and double wavelength e Following test methods can be provided Endpoint reaction method Endpoint Kinetics method Kinetics Two points method Two Points Double wavelength determination Dichromatic Absorbance determination Absorbance Multi calibration curve method Multi Calibration e Itcan perform the analysis of serum plasma whole blood and urine e Open for reagent and there is no specific restriction e English comprehensive report programming parameter as well as the data and reaction curve of quality control can be printed e Computer any external printer and external incubation position can be selected to equip with 1 2 Product property structure and composition It is composed of optical system channel system external computer control system and software etc 1 3 Product applicability It is for the clinical tests of body blood
6. and the tests of all kinds of routine biochemical indexs of other body fluids User s Manual 1 4 Instrument technique parameter Resolution Light source Wavelength Temperature control Flow Cell Interface Display Print Work environment Storage environment Weight Overall dimensions Power supply 0 001Abs Display 0 0001 Abs Internal calculation Halogen tungsten lamp 330 800nm continuously adjustable Room temperature 25 30 37L Flow Cell system RS232 bidirectional communication External displayer External printer 0 1 40 C 5 relative humiditys85 10 40 1 relative humiditys85 8kg 368mm L x192mm W x266mm H a c 110V 220V 11V 22V 50Hz 60Hz Power input 80VA Fuse pattern 05x20 Fuse specification 3 15AL250V 1 5 Instrument installation 1 5 1 Instrument Opening and Sealing Open the instrument package and take the instrument out of the box Take off the packing materials and take the instrument out of the plastic package Preserve the packing box and materials well and it s convenient for you to repack the instrument someday in the future Check the articles inside the package box and confirm the following stuffs should be included e Semi auto Chemistry Analyzer e 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 l
7. as shown in the figure 2 28 will appear al User s Manual Sample Hatch Delete Time Range EIEE 12 8 200612 8 gt Sample Range hn EM o Delete Close Hote lf Sample ID is nat selected all samples will be deleted within Time Range Or it will delete samples within Time Range and 5 ample Range Figure 2 28 Sample batch delete Select the frame of sample number range and the sample information within the set time and sample numbers will be deleted If sample range frame is not selected all the sample information within the set time will be deleted Note The sample information after deletion can not recovered please be careful to use this function 2 13 System setting It is mainly used to set the information of hospital name department sender test doctor examiner and clinical diagnosis etc Click System Setting on the main menu and the menu as shown in the figure 2 29 will appear Hospital Hospital Item Farameters Department Input Item Setting Section Input Method Doctor COM port liagnaose Figure 2 29 System setting 38 User s Manual 2 13 1 Hospital name Click Hospital the following window will appear Hospital Hospital i DK Cloze Figure 2 30 hospital name Input hospital name click OK and click Close to exit 2 13 2 Department setting Click Department the following window will app
8. be saved automatically 4 Cancel In the appeared new factor display window Click cancel and the calibration result of this time will not be saved it will return to the sample test menu automatically Note Calibration and quality control test only can be performed after that you have set the standard and quality control parameter Factor can be inputted or gotten from calibration test 2 4 2 Control test After finishing the blank test quality control has been set quality control can be performed at any time In sample test menu click QC button quality control select window will appear As figure 2 11 a m Control Select w Controli Control l Controls AVG 60 AVG AVG SD 25 SD SD Selection frame of quality contro In the Control Select window choose the quality control needed to be tested click OK key to start quality control test Click cancel key to cancel quality control test and return to the sample test menu Quality control results were listed in quality control result of Data of today menu quality control chart can be searched in quality control management C Cancel Figure 2 11 Quality control test 24 User s Manual Warning When changing from one test item to another test item the Flow Cell must be rinsed and the remnant reaction fluid should be washed Otherwise it may cause the error of test results 2 4 3 Change test it
9. 2 8 2 Data input It can perform the input editing or searching of the data of quality control tle ETETA teks x OC Chart ee en TestDate omon cowe co From 2006 12 08 33 To 20061208 Item Data Input Item Contoh Conto fo Cowo3 BatchNo TestDate 20061208 Quality control data list New Save Delete Exit Figure 2 22 Data input 32 User s Manual e Query Input the searching time period or item name click Query the data list of quality control will display the searched results e Data input 1 New Click New button select item name After inputting the corresponding quality control value batch number and the test date click Save 2 Delete Select a certain result among the Quality control list click Delete 2 8 3 Indoor quality control Click Chamber QC the menu of Indoor quality control appears as figure 2 23 QC Nanagement fx QC Chatt Data Input Chamber U Report Title Depatment QC samplel batchNo Lab No Ct QC sample2 batch No Year QC sample3 batch No Preview Season QC samplet batch TestDate 2006 12 08 QC samplefibatchNo iia Sample 4 sample Item item n depart spi sp2 sp3 sp4 spt manufacturer depat item 123 11 22 33 44 55 Sample 1 pi Sample 4 pd Sample 2 sp2 Sample 5 55 Sample3 s3
10. 2 9 2 10 2 11 2 12 2 13 2 14 2 15 3 1 3 2 3 3 3 4 User s Manual 244 Ol0S6 WINGOW ettet eee dededededededes ive ene tenete vede Mete dedeededeieetedededeteio tuse 25 2455 i r ello gEetin 9o dioe E 25 ODE HORE SOTITIG suo aa n t de oot EM d atv tenth M 26 milieu neidM ciet TTE LOT 27 2 6 1 curae REMIS 28 PA 2B DI add E detect d ne dd tM iie 28 miii Aic T TT 30 Quality contol GUC LY scs RD Eee CMM DRM DNUS 31 281 Quality corto WIDCOOW cett e eae esee ei dded ee eae eae stie d se seee toon 31 Zr LEM RII Ngoc 32 2 0 9 INGOOF QUAIILY CODO dii diede nica t eed iop a ee diva dou va dao ead iva dune 33 Calibra uom GUCI Y Met E 34 User mianagelTielit ct hehe cachet a Nacht ata ciclc ien nean 35 PN RIAM pP 36 2 10 2 Delete USE rc icici be a sa de MU MN M MN ME MR dca 36 210 3 KISS quitollZallOI sccececoiccececetae dece ttai enel deae bota aate ctio eoe cei ims 36 OVSIEMIIMAINIEN ANCE scare Aceves cue cni dieu ecd ose cdd dieu ecd adole 36 SAMPE eNA Ela m 37 SV Slem Mae saaa M 38 2t AOSHI MANNS erea dba dut ed dn ud ant eu aca enc ni tud dd ud un dad ku beds 39 2 19 2 Deparimerit Seung sous 2050 55005 20002002000 2808105 804 2001 084 2000 0044 8080 200 naan 39 2193 eclOmsellinis uu did ate ut eputetiveu qudd atu uM apu e M M C aM dU UE 40 2 13 4 Doctor information setup cccccecccccsseeeeeeeeeeeeeceeeeeeeeaseeeeseueeessaneeeesaaneess 40 2 13 5 D
11. 2 cable is in accordance with the settings otherwise it may cause communication errors 2 14 Data backup and recovery 2 14 1 Data backup This function is only authorized to Administrator Click Database Management under File in the main menu and select Backup as figure 2 37 Backup source path Do work tomaron destination path Backup Close Figure 2 37 Data backup Click key select Destination path to save data files and Click Backup to finish Note System must be restarted after data backup 42 User s Manual 2 14 2 Data recovery This function is only authorized to administrator Click Database management under File in the main menu select Restore the interface as figure 2 38 will appear Select the primarily backuped database and Click recover Restore Select a database to recover Figure 2 38 Data recovery Note System must be restarted after data backup This operation is only performed by the system administrator and common users can not try this operation 2 15 Exit system Exit this management system Click Close under the menu of File or Exit key in the main menu to exit the management System 43 User s Manual 3 Maintenance 3 1 Overview Semi auto Chemistry Analyzer is a clinical precise analyzer and daily maintenance work must be well done to make the instrument in good condition
12. 2100 2C GE uS 10 1 5 4 Connect instrument to power source eeeeesseeeeeeeeneneneeeenn 10 1 5 5 Connect external printer esses 10 1 5 6 Connect instrument to computer ccccccceecsseeeeeeceeeeeeeeeeeeeeeeeeeeesaaeeeeees 11 Coe Ol Do PRNEE EE EA A E ET 11 1 6 MSC UO NR DN D E ioe ete TC vor 12 LOk FONC WIG Emm 12 162 Keyboard and MOUSE sertetetet tet cteteteti te tutu ueste etienne elle lah ned 13 140 9 BACK VIGW uosestieo ee MEE ee eee 13 LOA xBIOWEGellius ib RE D E t ne us 13 1 6 5 Light source and peristaltic DUMP cccccccecseeeeeeeeceeeeeeeeeesaeeseeeeesaeeees 14 1 6 6 Principle structure figure Only for reference sessessssss 15 2 all OD Cla ll OM anosa 16 2 1 LOGIN ects vce tsetse AN 16 2 2 MANSON E es errr re corre Str errr er ertr er mere rr DS reer 17 2 3 A EI iMQecPtm S 17 2 3 1 WestinelllOO daidsatuidutsthunuscene tutu telhdt ctetu tcu ute ututueteb cL utucsmu RU d 19 23 2 QGallDralor Settings uana i conca uen acoge stadia aed ada adis 19 2 3 89 Quality control settings eeeeessssssssssseeeeeenennn nnns 21 2 4 Hem e IR DPI PRO EMEN 21 2r m EEC scuei immcm 22 232 JOB Ol SS oases aiio eet Cu n Rt eit us esi Gi Ca Da Ci eiua eiua Dun busca 24 249 Ghatige TEST ILeITI oooioc reto Eel einn he aciei Ee cuteni Fn detuce dedu edutenc ede fece eun 25 2 9 2 6 2 2 8
13. Bed Na EF Diagnose Note I Patient Numi f Edit State 4 4 4 4 Add Delete Preview F Print Al Form Info Operator Send Date 2006 12 08 v Sender xj Test Date 2006 12 08 Assuror x Alt Shorcut Ex Alt P Item Info Item Name Full Name L wm FulNam vae Tp gt Value Tip Add Delete Save Return 4 gt v lt gt Figure 2 16 Patient information 2 6 1 Patient information edit e Sample information Select the corresponding sample number and input the basic information of patients e Edit state Select this item only edit the sample numbers already existed i e when add patient cursor only changes among the sample numbers already existed Otherwise new sample number will be added while adding patient e Form information The inputted content of test doctor etc will be indicated in the report e Item information If the patient data is needed to be added or revised select a certain patient first input the basic information of the patient first click Add button choose the basic information of item input the qualitative and quantitative results and then click save button 2 6 2 Query print It is used to search and print the comprehensive report of patient In patient information window select Query print setting menu as figure 2 17 28 User s Manual Patient Info
14. IAGNOSE setings uisi e e E ec euadere cu oL CO NR 41 2 13 60 Input triethiod Selttlnis uo rtt o et eaten PO Puce ew od eed ix ede dede edt deveinil 41 2 19 7 Gom port SellligSiauiusn estatus astu nop phon Once hare eed nad ue ees eaduantes 41 Data backup and TecoVely cuius ise dion ed tnsu Sud onse Dies Roues Eas Drago ta dos 42 2 14 Data DaeckUp usseasssutvatette tette teonetocu eee vetu tuetur as Dae eee ius 42 2 14 2 Data recovery iad cccdecedacedccudaaedccaduaedccadaaedeiudetetcuatatacsuaaeteivacdetecaaad ten aaceeetuce 43 FEV E ign D m 43 Maintenance essssessesseseeeee nennen nnne nnn hannes na snas aa sae sae a 44 Sui P 44 Ie VS CHAS RUE cce desde dm uda iN RD NE duit us iuidedeu idit eeu tune dits 44 3 2 1 Clean the surface of instrument eeeeeeeessssseeeeeeeeeeeeeeenennn 44 o22 leal FIOW OEI orenen an Ren tette tte e dte te titt t ettet aet ARA AARAA REA 44 liastr ment malntenariee nearest eite eta cu ope ck aree o eene nk nuce ee 45 3 3 1 Ghange TUS eee eR ne ee ee 45 3 3 2 Adjustment of peristaltic pump tube ee cccceeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeees 45 3 3 3 Change of aspiration tube ccccccccccccccssseceecceeeseeeecceeeseeeeessaaaseeeesseaaees 45 3 9 4 Change light souree IalTip idee iet e eddie teet due d ee eiie d rete oder eeved ts 46 Simple trouble SHOODFIQ deiecit uenti ien tele nte nitet siete eiit 46
15. SIE Zero Mode o Purp Factor E i Zero Length 294 Zero Lengthl 300 i Temp Factor 0 Parameter 2 JK Cancel Figure 2 3 Initial setting A card is attached to the upper cover of instrument on which the values of above parameters are listed Input items in the card to corresponding position and click ok to finish initial settings 2 3 Item settings In item settings only administrator is authorised to modify the parameters as 2 8 User management Click Item Para button in main menu the following window appears Rayto Laboratary Management Information System vi Oe File Test Management System Setting Help ES te Test Patientinfo Item Para Exit Basic Para Print No 7 Temperature C n Li Upper LI 5 ltem Name fest Primary wavelnm Linear lower ALB GLB Full Name Jabsorbence Linear Range Unit mmol L Sample vol ful Blank None v e Delete Boc Wap ES 40 Upper 999 Reagent vol ul Reagen Bik ALT GLT Lower 333 Aspirate vol ful Mode Two Point Delay s r Digit Num 3 03 Read Time s 7 Pinem ila Save dE o ss ApoA ApoB Manu Print All az o ES ASTALT QC Setting Calibration Para m Du c zZ Calibration Method Concertration STD concentration n 30 O D Linear Repeat D 0 i GGT AST GLB doctor operator Shezhen hospital 2006 12 08 Figure 2 4 Item settings 17 User s Manual Click
16. The maintenance of Semi auto Chemistry Analyzer is very simple but it must be done carefully 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 Flow Cell must be cleaned under the following conditions 1 While powering on the deviation of water blank value is too big 2 Change test items 3 Before power off Cleaning method 1 Clean the outside of Flow Cell e Flow Cell must be placed according to the requirements Refer to 1 5 7 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 e After starting the instrument prepare enough distilled water and put it under the aspiration tube e Press rinse key on the instrument to perform washing e Each washing lasts about 5 seconds Warning Don t leave the reaction fluids or other pollutants in the Flow Cell for a long time 44 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 fus
17. Wave 340 nm 2nd Wave Delay Read Time Suck Vol Blank Calibration Linear Water BIk Factor Status 0 nm 10 s 1 55 500 ul None 2 935 170 000 User s Manual Water blank 2 935 A ABS 2935A Qc Print Chart Return prepare concentration is 70g L STD Figure 2 9 Standard tests 1 Test standard The status bar displays Prepare standard with concentration XXX aspirate the corresponding standard the system will test automatically and displays the results absorbance value Calibration curve can be checked in the Calibration Query window and printed 2 Re calibration Single standard calibration test in the new factor display window appeared after finishing test click Re calibration key to calibrate again Multiple standard calibration tests after finishing test click the Calibration button at the lower part of the screen to retest the standards Old Factor ong i Re Calibration cave Mew Factor 0 000 Tle Ihe test ABS U OD A Average ABS U DUC A ABS 0 000 4 Figure 2 10 Single point calibration result and return factor 23 User s Manual 3 Save results After finishing single standard calibration test new factor display window will appear Click Save to save the new factor and turn back to the sample test menu After finishing multiple standard calibration tests the calibration correlation coefficient will
18. c bath e Flow Cell bracket e Inner cover of light source e Flow Cell Figure 1 5 Flow Cell User s Manual 1 6 5 Light source 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 lens Se o ues bracket Screw 1 ET i Screw 2 Say 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 4 P X Fixing block P Adjustment Pump tube a Fi screw et OON ff i AU X 4 Pd P iy F ETA i eu Fa A Abl pA Fi PA e Ir 4 mu ee ago d d oe p oV XS OMIT MU i mu en AA js P d yp Pump generator 1 P Lap s oa a ATE dA C i e UA Xu M Water inlet P o x at j he Lope b y i rs M X 1 j M n L J i M 1 e o Pump installation board Water outlet Figure 1 7 Peristaltic pump system User s Manual 1 6 6 Principle structure figure Only for reference Mouse and keyboard Optic and singal Am colorimetric amplificatio transform Com
19. d 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 current over 220v Otherwise it may cause fire or electrical shock User s Manual 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 the power line with exer
20. e Fuse specification 250V 3 15A Users are suggested to use voltage regulated power supply Warning Must use the fuse of the specifications above When you are changing the fuse it is forbidden to operate with electricity 3 3 2 Adjustment of peristaltic pump tube After the instrument is used for half a year the position of peristaltic pump shall be adjusted The methods are e Rotate the lock catch of peristaltic pump tube clockwise and open the back plate of pump tube e Take off the peristaltic pump tube e Loose the fixing steel wire on the connecter of pump tube rotate the pump tube for 180 and then re fix the steel wires e Install the pump tube well and lock rotate the lock catch of peristaltic pump counterclockwise Warning If the tube installation is not correct it may cause the malfunction of fluid aspiration of the instrument 3 3 3 Change of 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 th
21. e entrance of flow Flow Cell 45 User s Manual lt lt Mee Figure 3 1 Aspiration tube connector at the entrance of flow Flow Cell 3 3 4 Change 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 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 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 shooting Trouble Shooting 1 Analyzer can not be started Check whether the instrument is switched on Check whether the power plug is loosened Check the fuse Check the power supply 2 The lamp is not lighted Check power supply before changing bulbs lf the lamp is damaged then 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 t
22. ear Department chirungery Department Chrenger medicine Shortcut hey ho paediatrics Figure 2 31 Department setting Click New key to input Department name and the code of shortcut key Click save and add another department Select the department name in the list click Delete and this department can be deleted After finishing all the inputs click Close to exit this window 39 User s Manual 2 13 3 Section settings Click Section the following window will appear Section Section Shortcut Key ery Area23 gt Section CERE 4 Area34 Shortcut Key 22 Add Delete Save Return Figure 2 32 Section setup Click add input Section name and the code of shortcut key Click Save and a section can be added Select a certain section in the list click Delete and this section can be deleted After finishing all the inputs click Return to exit this window 2 13 4 Doctor information setup Click Doctor the following window will appear Name operatora operator Shortcut Key 2 operators operators operators Mew Delete Save Close Figure 2 33 Doctor information Click New input Doctor Name and the code of Shortcut key Click Save and a doctor can be added Select a certain doctor in the list click Delete and this doctor will be deleted After finishing all the inputs click Close to exi
23. em Click test item open the board of item list select item needed to be tested click Start button Pressing it could open jhe item list Test ltem Parameter A Figure 2 12 Item changes 2 4 4 Close window After finishing the work click return button software will indicate To rinse the tube unit before closing the test menu As figure 2 13 Confirm Figure 2 13 Rinse indication Prepare distilled water click OK key and the instrument will start tube washing for 5 seconds automatically Click Cancel key to skip the washing procedure 2 4 5 Reaction curve print In sample test menu the current reaction curves can be printed at any time Click curve print button and print preview interface will appear As figure 2 14 25 User s Manual Printer zhm EPSON EPL 59001 v Setup Onentatior Portrait f Landscape gt Margins ae FE UN FRESE Marais 2006 12 05 v View Margins r Detail Proportional water blank 0 1234 E A E Printer settings Print settin Figure 2 14 Reaction curve print 2 5 Input item setting It is used to edit the information of item which is not test Input item setting 222 HBsAg SAg Meg tive ItemName HBsAg FulName HBsAg Print Na 222 Result Type Qualitative C Quantitative Ref Negative Prin
24. gent blank is selected the Reagent blank will be tested every time Click Print button If print all is selected all the existing item parameters will be printed Or only this item parameters will be printed Click New after input information such as item name Click save to save a user defined item After Click save software will display Save successfully otherwise error message will appear When user has revised or supplemented according to hints Click save again select the item needed to be deleted in the item list Click Delete system will ask you delete or not Click OK to delete selected item Click Cancel may cancel the inquisition of deleting item e Only administrator has the authorization to modify item parameters e I n order to make testing samples keep temperature stable and eliminate small air bubble in Flow Cell a certain time delays is necessary For most endpoint test time delay is 5 seconds Kinetics under 25 time delay should not less than 10 seconds Kinetics under 30 time delay should not less than12 seconds Kinetics under 37 time delay should not less than 15 seconds User s Manual e Print number of different item should not be the same Items that system can calculate automatically 1 GLB Globulin TP Total protein ALB Albumin ALB GLB 2 IBILI CIndirect Bilirubin TBILI Total Bilirubin DBILI Direct Bilirubi
25. he selected patient information will be added print mark If the option of print all in sample information is selected all the displayed patient report will be printed 29 User s Manual amp IM 4 b H gt 5 amp li iG be Shezhen hospital Sample Report Name we Sex eww Age 0 Sample ID 1 Cas eNo Department Section Sender Bed No Diagnose Send Date 2006 10 04 Item Full Name Result Tip Print Date 2006 12 08 TestDate 2006 10 04 Operator Assuror Figure 2 18 Print previews 2 7 Print by item Print all the test results within the selected time according to the items e Click Print by item under the Management of the main menu an menu as shown in the Window will appear Print Hy ltem Prnt By Item ltem AssaeMethod Upper Limit Lower Limit Time Span EINEE 12 08 at b 2006 12 08 l ltem g f Sel adapt A Pont C Double Punt All Print Preview Retur Figure 2 19 Print by item e Singly or multiple input Time Span and item name click search and the right side of the menu will display the searched results e Select the report print forms Sell adapt A4 print Double e After selecting the content needed to be printed or Print All Click print preview the picture as figure 2 20 will appear e Click print button to perform print 30 User s Manual Print Preview 8 Big gt n 828 5 x ce hospital Report
26. he test window Display the reaction curve 0 TiS alibratio ac Print Chart Return z Lo Select a item and click Start button to test Figure 2 7 Sample test 21 User s Manual Test Calibration Resutt QC Result Same Y e Test item Select the needed test item Click Start button start testing according to the instructions on the status bar e Parameter Display the current tested item parameters e Test column Display the reaction curve and the latest sample test results e Data of today Display the tested sample data of today including sample number test item result and the value of ABS e Status bar Display the tested procedure and indicate the related requirements of user operation e Sample ID change window Sample number will increase 1 automatically If this sample needs to be tested again change the sample number to the corresponding number and Click OK For example the current sample number is 2 change to 1 and click OK key it will retest No 1 sample e Print chart Click Print Chart could print the reaction curve Figure 2 8 Data of today 2 4 1 Calibration test After the blank test and standards has been set click Calibration to perform calibration test in the menu of sample test As figure 2 9 22 Sample Test Al Test ltem Y Parameter A Item Unit ALB g L Temperature PLT Made Two Point Primary
27. ist Please contact with the distributor when the accessories are not correct 1 5 2 Select proper position Find a place without direct sunshine in your working place The surface of the selected User s Manual working table should be flat and there is enough space for placing Semi auto Chemistry Analyzer and PC computer The anterior edge of instrument should be near to the edge of working table Avoid comparatively large shake of working table For example put hydroextractor on the working table Note The work environment of instrument is that temperature is between 0 40 and relative humidity is below 85 In order to guarantee the normal working of instrument the following places are forbidden to be put on e Places with extreme changes of temperature e Particularly hot or cold places e Places full of dust e Places nearer to the electromagnetic devices that produce magnetic field e Places with direct sunshine 1 5 3 Power source requirement e a c 110V 220V411V 22V e 50Hz 60Hz e 80VA 1 5 4 Connect instrument to power source 1 Insert one end of the power line into the outlet of instrument 2 Insert the other end of the power line into the outlet of power supply Warning Alternating current power must be well earthed 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
28. mbols on the instrument Symbols on the instrument ul m m B This symbol means that the labeled item is hot while the instrument is in use Don t touch the labeled item as you could be burnt The symbol is labeled on the lamp 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 the date of manufacture after which are shown its manufacture date 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 L k li aE HE The symbol means that the environment of instruments must be damp proof 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
29. n 3 AST ALT 4 LDH AST 5 GGT AST 6 ApoA ApoB 7 LDL CHOL HDL TRIG 2 2 Note e All calculation item must be set in Item settings at first and select Print item then they can be printed in comprehensive report of patient e Calculation time of calculation items will extend with the increasing of number of patients 2 3 1 Test method e Endpoint Endpoint method is that after mixing reagents and sample reaction reaches the endpoint after a certain 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 s Law Kits of some test item require to test with Dual wavelength in this way some interference factor can be eliminated This instrument provides Dual wavelength test method e Kinetics Kinetics method is that after mixing reagents and sample continually measure the absorbance value of reaction solution with photometer When absorbance value begin to change linearly measure its change rate concentration of reaction solution can be obtained according to Lambert Beer s Law e Two points Two points method test is a special case of kinetics test i e when absorbance value begin to change linearly measure the difference of absorbance of two points in the linear section thus obtain the concentration of reaction solution 2 3 2 Calibration settings In Calibrati
30. n menu administrator settings System Maintenance the menu as shown in the figure 2 27 will appear 36 User s Manual system Baintanace d zl Temperature Rinse tube Temperature 31 5 5 Set Temp Temp Factor Fump Factor Temp Rate IE Shut Light Time ALO Chg Light Date 2006 11 30 Chg Tube Date 2006 11 30 Save Return Figure 2 27 System maintenance e Temperature factor the factor of this item is used to revise the temperature e Pump factor the factor of this item is used to calibrate the pump e Shut light time In order to prolong the life of lamp the lamp of Semi auto Chemistry Analyzer will turn off automatically if the system has no operation after the set time Under test menu you can use keyboard and cursor time to turn on the lamp and begin test again Temperature It shows the real temperature of the current transducer e Save After revising the related data please click Save and return and the new settings become valid Warning Please pay attention when you change the correlation factor of system maintenance otherwise it may cause the error of the test results 2 12 Sample batch delete The function is only authorized to the administrator Perform batch deletion to the sample information according to the time range or sample range numbers Click File on the main menu Administrator settings Sample batch delete the menu
31. on Para column of Item Para menu as the following window User s Manual QC Setting Calibration Para Calibration Method Concertration value STD concentration Linear Add Repeat Save 3 Delete Figure 2 5 Calibration settings e Calibration method None Calculate on the basis of input factor calibration with standard is not needed Linear Linear calibration means using one or a group of standard preparation with the linear relation between the concentration and absorbance to calibrate Multipoint linear When the concentration of used standard is not in linear relation with its absorbance non linear calibration is used multiple standard with different concentrations are adopted at the most 8 standard with different concentrations Cubic curve regression Non Linear 3P Perform curve fitting regression according to the concentration of inputted standard Cubic curve logarithmic regression Non Linear Log it log 3P Perform logarithmic curve fitting regression according to the concentration of inputted standard preparation e Standard number The standard number of Linear method is 1 and Multipoint linear can set 6 standard numbers at the most e Repeated number The times of each standard been tested 1 2 or 3 can be selected e Standard concentration Click new button first input the value of standard 1 in the column of concentration repeat this step and input all
32. packaged 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 User s Manual Warning and Safety Indications This instrument is only used for in vitro diagnosis please carefully read the following warnings before the usage and strictly obeys them Warning Please carefully read the following announcements before using this instrument Cut off the power source at once if there is abnormal smells or smokes and pull out the power plug from the outlet At the moment you must immediately propose test applications to the distributors and the agents of our company If it is continuously used under this condition it may cause fire electric shock or personnel casualty Neither blood and reagent nor metal pieces of staple and pin should be dropped into the instrument otherwise it would lead to short circuit or smoke and fire If there is something abnormal cut off the power source at once and pull out the power plug from the outlet At the moment you must immediately propose test applications to the distributors and the agents of our company Operators don t touch the electric circuit inside the instrument especially wet hands which may be easier to get electric shock Rubber gloves must be put on while maintaining and checking the instrument and prescriptive tools an
33. 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 1 5 5 Connect external printer This system supports most types of USB Interfaces and parallel Interface printers Please connect printer to the PC mainframe connected with this instrument by referring to the printer user s manual and install the driver program for printer on the computer User s Manual 1 5 6 Connect instrument to computer 1 Cut off the instrument and computer power supply 2 Insert the two ends of RS 232 cable to the instrument and serial port of the computer Note In order to make the software Interface display correctly the resolution of your computer must be set up as 1024 x 768 1 5 7 Install Flow Cell Just as the following picture push away the upper cover of instrument after unscrewing the hand rotating screw which fix the upper cover Upper cover PP e Bracket for light Figure 1 1 Open the upper cover 1 Take off the adhesive tape used to fix Flow Cell 2 Take off the packing materials 3 Slightly insert Flow Cell into thermostatic bath the light hole directs to the direction of light source 4 Make the aspiration tube go through the fixing hole in the front panel of instrument and let it forwards extended 5 Install the upper cover and ro
34. puter LCD display rstem Printer Figure 1 8 Principle structure figure 15 User s Manual 2 Daily operation 2 1 Login Switch on the Semi auto Chemistry Analyzer first and then start Laboratory Management Information System The login window will appear Laborstary Banaggecnt Informstion System vi Be i Test Patientinfo Item Para Exit User i Password ees doctor 2006 12 08 Figure 2 1 Login window Input the original user name and password Click OK to login Original user name and password both are 1 the authorization is administrator they can be changed in User management after login refer to 2 8 If software can not detect Semi auto Chemistry Analyzer connecting to computer in 3 seconds the following window will appear Com port init fail Please make sure that the com connection are ready Figure 2 2 communication error Possible reasons that causes communication failure 1 Semi auto Chemistry Analyzer has not connected to power source User s Manual 2 RS 232 cable is not correctly connected RS 232 cable or serial port has been damaged 3 The COM port settings in the software COM port is not in accordance with the current used RS 232 cable refer to 2 11 8 COM port settings 2 2 Initial setting After install of the software initial setting window as follow will be displayed in the first time of use Init setting M
35. ration curve e Return Return to the main menu 2 10 User management Click main menu File Administrator Settings User Manage the menu as shown in the window will appear INTE MET NN Mame i E T TER Password s Operator operator Level Admin wr Daie Delete Save Close Close Figure 2 26 User manage 35 User s Manual 2 10 1 New user Click New button input the corresponding contents in the columns of Name and Password etc Select Operator operator settings refers to Section 2 11 4 and Level click Save key to save the user 2 10 2 Delete user Select a certain user in the user list click Delete to delete this user After finishing all the inputs click Close to exit this window 2 10 3 User authorization B Administrator User management i e newly add delete or revise user sample batch delete database backup database recover and system maintenance can be performed B Common user Basic functions of daily item editing testing printing and query etc Note It is suggested to set up only one administration user so as to ensure the correctness of the instrument configuration The test doctor corresponding to the login user will be displayed in the report list and it needs to log in again while changing users 2 11 System maintenance This function is only authorized to the administrator Click File on the mai
36. t All New Figure 2 15 Input item setting e ltem Name Item name in abbreviation e Full Name 26 User s Manual Full item name e Print No The smaller the value inputted the earlier the result of this item will be printed on the report e Result Type The result is qualitative or quantitative e Ref The natural result of the qualitative item e High The highest natural result of the item e low The lowest natural result of the item e Unit Unit of the item e Add item Click Add button after input the item s information click Save button to save the item s information e Edit item Click certain item on the list after edit the item s information click Save button to save the item s information e Delete item Click certain item on the list click Delete button to delete the item e Print item information Click Print button to print the item s information 2 6 Patient information It is used to edit patients information item information test result and search print etc Click the patient information column under the Management of the main menu patient information menu as figure 2 16 will appear 21 User s Manual Patient Info Search Print Setting SampelD Name Sex Age Sender TestDate n Sample Info Please click add button first then edit Name p sa Ja d a Section x Case pe Department
37. t this window The items of sender and checking doctors etc can be added or deleted according to the methods above 40 User s Manual 2 13 5 Diagnose settings Click Diagnose the following window will appear Diagnose Ih Diagnose lt Shorteuthey Iever Diagnose fever Shortcut Kep i Debe Save Clase Figure 2 34 Diagnose settings Click New input Diagnose information and the code of Shortcut key Click Save and more diagnosis information can be added Select a certain piece of diagnosis information in the list click delete and this piece of information will be deleted After finishing all the inputs click Close to exit this window 2 13 6 Input method settings oet up default input method Click the menu System Setting Input Method open input setup window Select input method after clicking the pull down frame Figure 2 35 click OK to save Input Hethod Setting Figure 2 35 Input method settings 2 13 7 Com port settings Click System setting in the menu Com Port open the selection window of COM port as Window 4 User s Manual COM Figure 2 36 COM port settings Click the pull down frame the first is the COM port list of the local computer Select the corresponding COM port and click ensuring New COM port can be used to perform device connection and communication Note Please ensure whether connection of RS 23
38. tate 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 11 User s Manual otherwise fluid flow is easy to produce bubbles and cause inaccuracy of test result 1 6 Main structure 1 6 1 Front view amp 89 GO 6 is Figure 1 3 Front view Indicating lamp1 State indicating lamp Indicating lamp2 State indicating lamp Indicating lamp3 State indicating lamp Indicating lamp4 State indicating lamp Rinse key Start or stop the rinse for instrument pipeline oteel needle for aspiration tube Conduct the aspiration tube to extend Aspiration key Press this key on testing state the instrument will aspirate the sample into Flow Cell automatically Labeling User s Manual 1 6 2 Keyboard and mouse This system is compatible with PS 2 and USB keyboard and mouse which is compatible with computer 1 6 3 Back view i Lt i Eg a Figure 1 4 Back view Hand rotating crew Fixing upper cover Fan Used for instrument cooling RS 232 Interface Communicate with PC Power supply interface and switch Connect Power line and Power switch control Peristaltic pump Provide power to aspirate liquid into Flow Cell 1 6 4 Flow Cell e Thermostati
39. tem ABS Test Mode 2x ou TestDate 2006 03 08 2006 12 08 Range 0 0 001 Sample ID Name Sex Age Result Unit Test Date 1 0 0 000 mmol L 2006 12 06 10 0 0 mmol L 2006 12 06 11 0 0 mmol L 2006 12 06 Tt 0 4 mmol L 2006 12 06 13 0 4 mmol L 2006 12 06 2 0 0 000 mmol L 2006 12 06 5 0 11 mmol L 2006 12 06 7 0 0 mmol L 2006 12 06 8 0 0 mmol L 2006 12 06 3 0 2557 500 mmol L 2006 12 06 14 0 2571 563 mmol L 2006 12 06 Prnt Date 2006 12 08 Operator Assuror hospital Report Page 1 of 2 Figure 2 20 Print preview 2 8 Quality control query Input quality control item to search quality control window 2 8 1 Quality control window Click QC Management under Management the following window appears User s Manual QC Hanagement Time Span Item Batch No Plot Methad i Control Qc Tip 2006 12 08 me 2006 12 08 fo C Sel value Set value Conto 1 s E i i j Preview hospital QC Chart TestDate esu 3sd 2sd sd avg sd 2sd 3sd 1899 12 30 Figure 2 21 QC management In Quality control window select time span item name quality control and batch number Click Plot key to draw the corresponding quality control chart with the time Quality control indication Quality control can be indicated whether it is controlled according to the selected quality control principles Print preview It has the function of previewing and printing the displayed quality control chart
40. the items to be changed in the item name list on the left side the basic parameter of this item will be displayed at right User can edit the parameters standard settings and quality control according to the reagent instructions Users can also define test item by themselves Print number Item name Full name Unit Mode Digit num Factor Temperature Primary wavelength 2nd wavelength Aspirate vol Print item Head time Reagent blank Print New Save Delete Note The smaller the value inputted the earlier the result of this item will be printed on the report item name in abbreviation Full item name 8 conventional units are provided in pull down list input unit also can be defined by user Three test methods can be selected endpoint two points and kinetics Details are shown in 2 4 1Test method Default value as 3 If calibration method of this item select Factor here must be filled Ambient temperature 25 300 and 371 Input required wavelength in 330 800nm Double wavelength test is only suitable for endpoint method item If secondary wavelength is not required please select 0 Test the amount of imbibed liquid usually is 500uL If this is not selected the item will not be printed According to test requirement fill in Reading time When test methods is endpoint method it need not to be filled Showing the latest absorbance value of reagent blank If Always retest rea
41. the standard concentrations one by one After finishing adding click save button to save the concentration Click delete button to delete the current concentration value Note Before saving the standard with blank concentration value should be deleted first Software will re calibrate after revising the standard concentration 20 User s Manual 2 3 3 Quality control settings In the Item Para window select QC Setting and then the quality control information of this item can be edited QC Setting Calibration Para Control 1 Batch No 001 ANG 1 so 1 Control z OC Rules AVE E v 1 value exceeds 35D so E 2consecutive values ereed 25D on the same side Contro 3 Sconzecutive values below 25D on the same side AV 3 j F consecutive values ereed AVG on the same side SE Figure 2 6 Quality control setting e 3 quality controls can be set at the most e AVG Average Input the target value of the inputted quality control e SD Standard deviation Input the SD value of the inputted quality control System will get the corresponding value of 1SD 3SD automatically e Quality control rule Quality control rules can be singly or multiply selected e Batch number The corresponding batch number of quality control 2 4 Item test After finishing the parameter setup of item test users can perform item test In the main menu Click test icon or open the menu test test enter t
42. tion 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 User s Manual Content How to use this manual cccceccecceeceeceeceecaecaecaecaecaecceeseececeesesaees 2 SVIMDOIS OM TNS Is FUIL cce i oaa RR CIUEE HERE DER tite Rc pa ER URINE 3 Warning and Safety Indications ccccceeeeceeeecseeeeeeteeeeneeeseeeteneeees 4 1 Brief introduction of instrument cccceeeeeeeeeeeeeeeeaeeeneeeneees 8 1 1 miele U e introducti BENE RTT E 8 1 1 1 Product name Semi auto Chemistry Analyzer sesseeuusss 8 PL2 Ier e ME 8 LES Product Property iusso mcr vw uu uv tV cna 8 1 2 Product property structure and composition sseeeseeeesses 8 1 3 PrOOUCLAPPICADNINY r S o S DS 8 1 4 Instrument technique parameter sssesseseseneeennen nennen 9 159 llaStrgpment InStalldtlQLD cee ee x i x een xe d tede edet 9 1 5 1 Instrument Opening and Sealing eeeeeeeeeseseeeeeeeeeee 9 1 52 Select proper POSON eta canet e one tte tete tent tette tdt bat testate eden 9 1 5 3 Power source requirement cci e oae sacu e peo EPOR I0 0001 2105 0001
43. ube 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 46 User 6 There is no reading on the photometer 7 The Deviation of water blank is too big 8 The result reproducibility is low s Manual Check whether the lamp of photometer is lighted Try another wavelengh 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 9 The aspiration volume of Flow Cell not 10 Quality control out of target value range 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 stable 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 47
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