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1. Model M Fig 3 6 Blood sample counting screen If Print instantly setting is selected the instrument will print analysis result automatically after test ends If counting and analysis operation environment is below 15 C or over 35 C the analysis result of the blood sample will be unreliable the Temperature Low or Temperature high alarm will appear in message field of screen If block hole or bubble appears during counting and analysis Block hole or Bubble alarm will appear in message field of screen If the remain volume of reagent is not enough the message field will appear Reagent volume not enough it will also indicate which reagent is not enough such as diluent cleanser and Lyse If test result exceeds system output range parameter result will be shown as check validity of test sample then Note 1 if sample splashes out of sample cup please make necessary protection when cleaning never touch sample directly 2 Please check remaining reagent amount periodically if aspiration tube fails to aspirate thoroughly please replace reagent 3 Sampling needle movement may cause body injury watch out during aspiration 3 4 3 Parameter prompt message H indicates that parameter test result is higher than maximum of predetermined pathogenic value L indicates that parameter test result is lower than minimum of predetermined pathogenic value H indicates that param
2. Delete shortcut key to delete this test result eliminate related fault before next test 3 Each QC file can save at most group numbers preset in QC setting x number of samples in each group QC results Press Exit button to return to main screen 4 3 3 X R QC list The instrument can look up X R QC data by listing In main screen select QC file go to QC list as follows K Send 5 PE Delete D ld Help Wl packed Fig 4 12 X R QC list The instrument will display 20 parameter QC result Click Send button some or all QC results can be transferred to external receiver Operation method is the same as data transfer in 4 1 3 L J QC list Click Delete button deletion confirmation dialog box pops up After confirmed some or all QC data will be deleted 4 3 4 X R QC chart X R QC chart can visually reflect instrument stability when instrument is under control points in chart will randomly distributed on both sides of centerline the farther from centerline the nearer to upper lower control limits there will be fewer points Graphic screen is as follows 2 Auto Hematology Analyzer User s Manual Lot 600 Expiry 2008 11 01 seg Graph AGraph 0 Graph H Graph Fig 4 13 X R QC chart lt gt Lot No lot number of QC object lt gt Expiry validity period of QC object lt gt Seq sequence number of current QC point Each screen displays two parameter QC data distri
3. Blank test only shows test results of WBC RBC HGB HCT and PLT The operator can run blank test at any time required In sample test menu click Profile button after Data Edit menu pops change sample no to 999 then click Yes button return to sample test menu Press Aspiration Key to start blank test During test the indicator light turns red status column on top of screen will display test status 14 Auto Hematology Analyzer User s Manual Blank test acceptable range is as follows Reference Range WBC lt 0 2x10 L lt 0 02 x 107 L s1g L lt 10x 10 L If blank test result exceeds this range operator has to repeat above test steps until test result is acceptable If after 5 runs test result still cannot meet specification please check reagent and tubing connection and use Back Flush function in Service module to eliminate block hole After blank test one can fill out sample no manually in Data Edit menu or click Return button to return to main screen go to Sample Test menu again to run sample test 3 3 Blood sample collection Blood sample collection is classified as venous blood and peripheral blood Warning do not touch blood sample QC sample and calibration sample directly Handling of these objects shall comply with related operation instruction 3 3 1 Venous blood collection Venous blood can be collected by using vacuum negative pressure tube or ordinary metho
4. 3 In accordance with packing list make sure the packing carton content includes e Hematology analyzer e User s manual e Packing list e Agent warranty certificate e Power adapter e Product COA Note Product packing feature is as per packing list in case of inconformity please contact seller 2 2 Installation environment In order to ensure instrument work normally please choose working place compliant with following condition to place Auto Hematology Analyzer e No direct sunlight eo No massive dust or powder e No strong electromagnetic radiation e Sufficiently large flat and solid desktop Note Instrument working environment temperature 15 C 35 C relative humidity 10 90 2 3 Power requirement e a c 110V 220V e 50 60Hz e Y96VA Warning 1 AC power must be well earthed 2 AC power shall be stable sharing with heavy duty power appliance is forbidden rectified power supply is better equipped 3 If there is smoke smell or noise in instrument immediately shut off power and contact distributor 4 When plugging power line one must catch the plug itself instead of power line 12 Auto Hematology Analyzer User s Manual 2 4 Reagent The instrument needs to use Lyse cleanser diluents for measurement and maintenance To ensure accuracy of test result please use reagents accompanied with instrument 2 4 1 Connection of Lyse and cleanser 1 From reagent packing carton take out lyse and clea
5. 0 00 3 00 20 00 0 00 3 00 0 10 0 10 x Delete D Helptty El Exit Fig 4 3 L J QC run Have QC sample ready press Aspiration key to start test After test QC run result will be shown under current QC number column If fault alarm occurs in test this test result may be inaccurate You can click Delete button to delete this test result Eliminate related fault before next run If out of control rule is set during QC setting in case of inconformity with QC rules in running the system will prompt the user can delete current QC run result and test again Each QC file can save at most 500 QC results Press Return button to return to main screen 4 1 3 L J QC list The instrument can look up QC run data in list In main screen select QC file enter QC list as shown below 22 Auto Hematology Analyzer User s Manual L J QC List QC 1 l Targets Limits 1 2 3 4 5 6 2008 05 24 2008 05 28 2008 05 28 2008 05 28 2008 05 29 2008 05 29 15 25 59 08 40 18 09 11 50 09 12 50 14 12 50 14 13 20 9 70 0 30 9 60 9 75 9 70 9 65 9 78 9 50 4 21 0 50 4 20 4 30 4 15 4 25 4 20 4 00 111 00 10 00 115 00 111 00 108 00 120 00 117 00 120 00 84 30 0 80 82 02 51 96 48 82 TO 30 60 60 60 60 278 00 20 00 280 00 278 00 265 00 276 00 260 00 279 00 yy Send S x Delete D Helptty El Ext Fig 4 4 L J QC list The instrument will display 20 parameters QC result if some parameters are not controlle
6. 15 34 BIOOG Sample analVS IS uni n iii 16 3 41 Sample data lluita 16 AZ Ieo Sample COUNTING aisan Oe oder acne aee deste eee ene ree erate 17 3 4 3 Parameter prompt MESSAGE ccccccecceeceeeceeteeceeeseeceeceeeseeceeceeeaeeneeseeeeseesenes 18 3 4 4 Histogram Prompt MESSAGE cccecccecceeeceeece cece eeeeeeeeeseeeceeeseeeaeeeeeesaeeseeeseeseeeees 19 SAA USAS IO AM T 19 A A An 20 AQUA CONTO aansen 21 EES A A 21 Auto Hematology Analyzer User s Manual A EA ee eee ee ce een er eee anne eer eee 21 R EA O OS IS ete te eon CA Sn OC TEED a eR II E AED 22 74 hg EE AAA A A aE RRA te 22 Ya Wg Oe ES OO Ea yo eae en TT ead ee 23 BD E a EE FEE Secietnsndaaeine eandeteaieadicdnaiodiniwSdihaiebnd ndnichied niindieeed a Sndicl delete deena 24 4 21 XB QC lee sii dida 24 A2 ey POC I a E A Pea NE eR eee een 25 7s Ng AG O A ORE A ne Pe Ee ORL eae ne ee 25 BD DRO A e PR O TTIETIETTEE TT TEET TE 26 AS ARNO Setin goera a dead 26 SO O A A A AN 26 AO SNS ute tata td e dao lis do DO eel y ide 21 ASA SERE A is 21 AS nee eee eee eee eee 29 5 1 Preparation before calibratiON occoccoccocconionionnonnonnonnonnonnonnonnonnonnonnons 29 5 2 Mantal eine hel sisi dde dc doc dedicas 29 5 3 Auto calibratiQON x 30 AS 33 LOYSN OCUN aan 36 TA Genecral SeU insti ia 36 LONO A eee ee ene Rae nena ene eRe tree 37 ARI Sl AA A A iat 37 AA SA A 38 KESPR AN A A AO AER A een Ren er ree 38 ALAS ts at da deta E a ot edi oo Oo al ao Sue edo E
7. 5 years GRA 30 80 RDW SD 25 170 n 25 70 C 3 months 2 yi PLT 60 350 Xx 10 9 L HCT C 8 days 2 mor MPY 65 15 fL PDW 5 25 C Fi m First week PCT 0 05 a User defined P LCR 10 55 ES Save S Help H Back X Fig 7 6 Panic limits Reference range of each parameter has been set before delivery of instrument to modify parameter reference range you can select blood type and population category and fill in parameter lower limit and upper limit blanks click Save button 7 2 4 Units To change parameter unit click Units button open Units setting menu as follows Unit Setting WBC LYM MID GRAg EN lt LYM MID GRA RBC fonz y HGB g L y MCHC g L y HCT 6 lt l MCV fL MCH pg RDW CV RDW SD fL PLT fios z MPY fL PCT 9 PDW P LCR Fig 7 7 Units setting Totally units of 10 parameters can be set WBC LYM MIDA GRAF use the same unit Select appropriate unit and click OK to save and exit click Cancel the Units will not be changed 7 2 5 Communication Communication setting is used to set up each parameter value for serial port transfer interface to check or modify these settings click Communication button open communication setting menu as follows 39 Auto Hematology Analyzer User s Manual Communication Setting Bauds 115200 Length 8 Parity None Stop fi Fig 7 8 Communication
8. Delete Delete function can be used to delete selected data and all history data Data can be selected in following methods a use select function b Use mouse or touch pen to click list column select one history data Using keyboard Ctrl key or Shift key multiple 34 Auto Hematology Analyzer User s Manual columns can be selected If no data are selected the system will prompt to delete all sample data o Print Print function prints selected history data according to system setting print mode See print setting in Chapter 7 System Setting o Detail Detail function is used to check detail data message of a certain sample select one record in history list click Detail button and go to Sample Detail Message Review menu as follows E Ong Sample No 3 Type Whole blood Time 2008 11 05 10 07 14 CurfTotal 3 13 Reference General Name Sex Age Medical No Bed No Dept Applicant Inspecto Verifier WBC 3 49 x 10 97L L LYM 2 31 x 10 9 L MID 0 14 x 10 9 L GHAR 1 04 x 10 9 L L LYM 65 74 H MID 4 09 H GRA 30 17 L 100 150 200 250 300 35 RBC 1 79 x 10 2 L L HGB 60 gil L MCHC 330 54 g L MCH 33 38 Pg MCV 100 98 fL H RDW C 11 66 RDW SD 40 35 fL HCT 18 06 L PLT 98 x 109L L MPY 9 02 fL PDY 14 02 PCT 0 09 L P LCR 35 88 LF2 Fig 6 6 Sample history data This menu displays sample basic message test value and histogram click Previous item Next ite
9. current QC point in all QC data points Each screen displays four parameter QC chart Mean average Diff standard deviation CV variation coefficient of each parameter Three values on the left of QC chart are from top to bottom QC sample target value deviation QC sample target value QC sample target value deviation respectively Press T keys on keyboard or frame to switch between items gt keys on keyboard or frame QC data of different sequence Numbers can be gt gt KER Press e shown Press Print button to print out one current group of QC data 4 2 X B QC X B QC does not use QC sample same as QC of QC sample it belongs to instrument quality monitoring method they can reflect machine inspection quality from different aspects and not interchangeable X B QC data stem from random sample not classified according to disease type The given value and upper and lower limits comprise a reference range observe trend of each lot of X B values in reference range The instrument makes X B QC of all 20 parameters quantity of samples for X B numeric analysis in each lot is within 20 200 the default is 20 4 2 1 X B QC setting SP OC Setting l NumberfGroup 20 z00 E X B Analysis OFF E hem Targets Limits hem Targets Limits woe 23 14 10 9L RBC 429 0 15 VOZ Lyme 10 32 1 32 1830 HGB 129 5 gil MIDY 2 7 0 2 xn MCHC 344 30 gil GRAY 4 7 T XIIL MCH 29 pa Lymn 44 7 10 MCV
10. of current QC file if there is data in this QC file then update e Rules select QC rules of this QC file you can unselect select one or more System will make out of control determination and alarm in QC test according to these rules QC rules frame is shown below A QC Rule Y Once exceed 35D Y Consecutive twice exceed 25D Y Consecutive 5 times at the same side of bias between 1SD and 25D Y Consecutive 7 times at the same side of bias OK Cancel Fig 4 2 L J QC criterion eo Items user may select all parameters for QC or select part of parameters for QC eo Delete delete QC data of QC file currently selected Oo Send use instrument RS 232 serial port to transfer QC data of QC file currently 21 Auto Hematology Analyzer User s Manual selected to designated receiver Prior to transfer please use RS 232 serial port cable to connect to equipment ready to receive data start up and set up receiver software parameters For setting of instrument transferring terminal parameter please refer to Chapter 7 System Setting Help to display system help Exit return to main screen 4 1 2 L J QC run After QC parameter setting of selected QC file is done QC analysis of this QC file can start In main screen select QC file enter QC Run screen as shown below L J QC Run AQC 1 Lot 7854 Expiry 2008 12 31 Limits 0 30 0 30 0 30 0 30 2 00 3 00 3 00 0 50 10 00 2 00 0 00 0 80 0 00
11. once every three days 10 2 9 Check mechanics In Service menu click Check Mechanics key open mechanical test menu as below A Mechanics Result Needle sl Carriage Liquid Syinge Coo Valves Fig 10 1 Mechanical test 7 KK 35 KK Click Needle Carriage Liquid Syringe Pressure Syringe respectively the instrument will test working condition of these components respectively the results will be shown in corresponded boxes on the right While component is moving carefully watch whether component movement is smooth and uniform if there is still anomaly after repeated tests please contact The manufacturer customer service department Click Valve button open solenoid valve test screen as shown below 46 Auto Hematology Analyzer User s Manual Valve 1 Valve 2 Valve 3 Valve 4 Valve 5 Valve 6 Valve 7 Valve 8 Valve 9 Valve 10 Valve 11 All Valves LLL L LLI illl Exit Fig 10 2 Solenoid valve test The instrument has 11 solenoid valves totally you can click corresponding button to test or click All solenoid valve button to test all solenoid valves at the same time If valves are normal the movement shall be smooth and regular Click Exit button return to mechanical test screen Function of each solenoid valve is as follows Solenoid valve 1 to control lyse solution dispensing Solenoid valve 2 to release positive pressure and n
12. setting Instrument default values are Baud rate 115200 data digit 8 calibration digit None stop digit 1 to modify setting click dropdown box select other different value click OK button 7 2 6 Department information Department information is used to set up department data of user unit user message setting and sample data entry will use department message preset these messages will speed up department data input Click Dept Info button open department message menu as follows Noo Dept O Department Append A Modify M Fig 7 9 Department message setting 1 Append click Append button to add one row of blank column input department name in department column click Append button the added department message can be saved 2 Modify Select the column you want to modify input new department name click Modify button to update the info If the input is blank it will not update 3 Delete select one row or several rows of data click Delete button confirm and delete selected department message 4 Exit return to other setting frame 7 2 Doctor information Doctor information is used to set up individual doctor data which will be sued in sample data entry preset these messages will speed up doctor data input Click Doctor Info button open doctor information menu as follows 40 Auto Hematology Analyzer User s Manual Sender Scrutator Checker
13. supply shall be immediately cut off and the plug of the power supply is extracted from the power socket Meanwhile the inspection apply shall be immediately presented towards the distributors and the agents of this company The operator shall not touch the electronic lines in the instrument especially there will be a danger of electric shock when they are touched by a wet hand The rubber gloves are required to be worn and the prescriptive tools and parts must be used when the instrument is maintained and checked When the operation ends please wash your hands using disinfection solutions or the infection electric shock or scald might be caused to the part of the skin which contacts with the bloods When the samples are handled the great care shall be paid and the rubber gloves must be worn or the infections might be caused If the samples enter the eyes or wounds they shall be immediately washed using a large amount of clear water and inspected by the doctor Usage of reagents The reagents shall be avoided from contacting with the skins and clothes when the operation is carried out If the reagents enter the eyes immodestly they should be immediately washed to be clean using a large amount of clear water and inspected by the doctor If the reagents are wrongly drunk the help shall be immediately obtained from the doctors and simultaneously a large amount of water shall be drunk so as to vomit the reagents If the hands or ski
14. 12 20080505013 20080505014 2008 05 05 2008 05 05 2008 05 05 2008 05 05 2008 05 05 2008 05 05 08 10 23 08 33 40 08 35 00 08 52 48 08 56 46 08 57 48 0 06 L 0 07 L 0 05 L 0 03 L 9 63 0 07 L La E Pe aoe 4 12 h e aioe Jsa ae e 0 90 at ioe Po S 4 61 bce sei e not e ale 42 74 E es oa SE S 9 34 E LE ua sae TER 47 92 pace 0 00 L 0 00 L 0 00 L 0 00 L 4 08 0 00 L Total records 1431 Current Records 431 Page 3 lt lt gt gt Select Send Locate Search Delete Detail Print Order Back Fig 6 1 History record list Home screen of system displays the latest 500 records H L or H L after parameter indicates that test result exceeds upper limit or lower limit of system setting parameter pathogenic value or normal value Test result with indicates that result is beyond test range or fault occurs during test If history record number is greater than 500 you can click lt lt and gt gt buttons to switch between browsing data o Select Click select button open select dialog box as follows Fig 6 2 Select dialog box Input record sequence numbers to choose in starting point and end point edit boxes click OK if the same value is entered in starting point and ending point edit boxes then the record this value corresponds to is selected Click Cancel button the system will not select any record o Send It provides data transfer fu
15. 84 3 b fl MIDA 6 8 6 ROW CY 13 5 x GRAM 40 5 0 L ADWSD 40 5 13 5 R pr 270 20 lt 19 9n HCT U 1 MN 25 15 i Pow 16 2 C9 PCT D 1 1 PLCA 28 15 L SavelS dl item xl of SendiE Y Delete1D Helpity a Exit Fig 4 7 X B QC setting If X B analysis is On samples are tested and also taken as X B QC analysis data X B QC target value and limits are calculated and filled out by user manually Parameter target value is the average of statistic calculation result of sample data after test in this region samples shall reach a certain amount its recommended quantity is above 1000 and sample source shall be verified to be random data reference values of different regions will be different Limits choice is recommended to be 5 10 O Save save QC setting data eo Items user can select QC of all parameters or select QC of some parameters eo Delete delete X B QC setting data Oo Send use instrument RS 232 serial port to transfer X B QC setting data to designated receiver Before sending please use RS 232 serial port cable to connect to equipment 24 Auto Hematology Analyzer User s Manual to receive data start up and set up receiver software parameters For instrument transfer terminal parameter setting please refer to Chapter 7 System Setting o Help display system help e Exit return to main screen 4 2 2 X B QC list The instrument can save at most 2000 X B QC data open X B QC list as s
16. Dd 39 12D eT rT aKT eT 39 7 2 6 Department InfOrMati0ON occcoccconccocnconnconnconconnnocnconocanonnnnornnnrnnnnnnnnnnrnnnnononenennnos 40 TL Raes e VION dois 40 AS 42 919 YSIem SlU S esa dao 42 0 2 os AO Ann eee ee eee 42 ea ao E 42 O A o e nee ee e e eo 44 O A A E EEA E AET 45 10 1 Routine maintenant e anana 45 10 1 1 Startup and shutdown process ee eee e ee 45 TO EZ S Tey nn e vise al ente cd A5 10 1 3 Clean instrument surface 0 ccc cece ccccceccccecccccccccececcaccccaecceneceeceaeceeneansneaesnsatars 45 Auto Hematology Analyzer User s Manual 10 2 Maintenance program sese eee eee eee 45 naa Back MUS iY ir td 45 1022 BUN ener ne ne meron A 45 1023 Drain cha ue Scioli redadas 45 1024 Dran PIPE os 45 10 20 REMOVE Blockage wise steeds achat ta dd tad 45 A A eat 46 10 21 ota dad 46 10 2 8 Concentrated cleanser Soaking sese 46 10 29 Gheckmech ames A E ai 46 OZ ADDED scan e 47 LIA A o A 47 TO 212 Machine TOSE a e 47 19 213 SOP US Orusco ica 48 10 2 14 Replace reagent oococccooccconcconocononnnoononononononcnnonocononnnnanonanonnnonnnnnnonanenanennnnnnos 48 MI OUI SSO ONIN esa e 49 Appendix Name and concentration of toxic and hazardous substance or element IN product see ee ee ee ee eee 50 Auto Hematology Analyzer User s Manual 1 Instrument Introduction 1 1 Product introduction 1 1 1 Product name Auto Hematology Analyzer 1 1 2 Test items This analyzer is using impedance princip
17. Laboratory Equipment sd Pa www mrclab com Ne S THE STANDARDS INSTITUTION OF ISRAEL Operation Manual for Auto Hematology Analyzer HA 17600 nak TEE i ram TO AL 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 4 12 Auto Hematology Analyzer User s Manual Thank you very much for being the user of Auto Hematology Analyzer In order to get best test result before doing clinical test you shall be familiar with this analyzer and its performance This user s manual is the using guidline of Auto Hematology Analyzer including installation daily test QC and daily maintenance The functions of insrtruments with difference versions or configurations may be different The content of user s manual may be different because of upgrade we will not give notice seperatily If you have any question please contact the distributor Please reserve all packing materials for storage transportation and return to fctory for maitenance If any problems come into existence please contact the distributors Note prompts advice or suggestion using italic Warning warnings must be followed strictlly to make sure the normal performance of instrument and the accuracy of test result Declaration The manufacturer reserves the Power of Interpretation to this user s manual The figures in the manual is only for demostration th
18. N N N Name Dept T Sender Scrutator Checker sa Porno nan nn nana n an anna nan en nan ran rra nan annarannnnncnnnos Append A Modify M Delete D Jeccssscsssscssssssscsscsssscessssssscsssesssesssossaeed Fig 7 10 Doctor setting Append click Append button to add one row of blank column input name in name column select department sender tester and checker from dropdown list Set up department in department message type N in sender tester and checker boxes indicates that the doctor is not of this identity Y indicates that this doctor has such identity Modify Select a data column you want to modify input new information of the doctor click Modify to update the doctor s information If the input is blank it will not update Delete select one row or several rows of data click Delete button confirm delete the selected doctor message will be deleted Exit return to other setting frame 41 Auto Hematology Analyzer User s Manual 8 System Information System message provides several types of message about system user can check system status through system message function module 8 1 System status On system message menu of main screen click System Info key the click system status go to system status menu as follows Item Current value Range Temperature 27 6 15 C 35 C Internal pressure 240 0 500 Pa Exit X Fig 8 1
19. USB interface socket 3 Insert another end of USB cable into instrument USB interface 4 Connect printer and AC power supply with power line accompanied to printer 13 Auto Hematology Analyzer User s Manual 3 Sample test 3 1 Preparation before startup Before startup the operator shall check by following steps to make sure system is ready 1 Check if the diluent Lyse and cleanser meet the need of current test Check if the waste bottle is full tubing system is ok and without folded all the connection is ok 2 Whether instrument power adapter is safely and stably connected to power socket 3 Check whether built in or external printer paper is sufficiently installed in right position 3 2 Startup Switch on the indicator light is on system begins to check component status transfer parameter needed by front end run blank tests as shown in figure below Mechanics Checking m Fig 3 1 Startup program After startup self checking go to sample test screen as shown below E 3 Current Name 1 Sex Age WBC 0 09 x 10 9 L LYM HER Xx 10 9 L MID AR x 10 9 L GRA kid x 10 9 L LYM RR o MID RR GRA RR RBC 0 x 1071 2 L HGB 0 g L MCHC g L MCH baa pg MCV LA fL RDW CY RDW SD ODEJ fL HCT 0 PLT 2 x 10 9 L MPY bid fL PDW L PCT bead P LCR RR Confirm C Profile D Print P Help H Diluent Adjust G Model M Fig 3 2 Blank test result
20. alibration sample select parameters to calibrate 2 Test calibration sample 3 Determine calibration coefficient Auto calibration screen is as follows 30 Auto Hematology Analyzer User s Manual Lot Expiry Sample OLD COEF amp Setting X Delete D R Save S ES ome Helpten ees Fig 5 2 Auto calibration At first calibration sample is to be set up click Setting button open auto calibration setting menu as shown below Lot ww Input Expiry 2009 H Y jos a M o1 D Blood Type Whole blood C Peripheral blood C Pre dilute peripheral blood Targets WBC 9 70 X10 9 L RBC 4 21 x 10 12 L HGB 122 00 giL RDW C 13 00 RDW SD 40 00 fL MCV 84 30 fL PLT 278 00 Xx 10 9 L MPY 8 50 fL PDW 116 00 P LCR 30 00 Items Y WBC IV RBC V HGB V MCV Iv RDW CVY M RDW SD M MPV M PDW M PLCR M PLT E O ent XK eto E OK 0 a Exit X Fig 5 3 Auto calibration setting gt Lot No lot number of calibration sample input and save on next logon you can select from dropdown list check or modify data of this lot no Click Input button to input lot No gt Expiry validity period of calibration sample if validity period is less than current system date when confirmed to return the instrument will give alarm of using another calibration sample to calibrate gt Blood type blood type of calibration sample gt Targets reference value of each parameter of calibration sa
21. all QC data will be deleted 4 2 3 X B QC chart The system provides graphic to look up X B QC analysis data as shown below XE OC Graph i CurentfTotal Time 2000 07 09 09 20 31 wee 8 7 E 4 3 ao 44 474 4 14 ALA gt ene ma on Fig 4 9 X B QC chart lt gt Current Total to display current QC data point location and X B QC analysis total lt gt Time test time of data corresponding to QC point Each screen displays four parameter QC chart Three values on the left of QC chart are 25 Auto Hematology Analyzer User s Manual from top to bottom target value deviation target value target value deviation Press 9 keys on keyboard or frame to switch between parameters Press KK keys on keyboard or frame to display QC data of various serial numbers Press Print button to print out one current group of QC data 4 3 X R QC X R QC or mean range QC is common quality control method in industry an efficient way to determine and forecast abnormal fluctuation of quality it complements with L J QC each other X R use QC sample for QC analysis X R QC primarily use control chart to reflect QC data stability its QC chart is a combined chart 4 3 1 X R QC setting Before running X R QC necessary QC parameter setting shall be done setting screen is as follows Lot reses Expiry Sms f jos gt M 105 Id gt P N LTTE MET Sample nam per gro
22. aminated test again in other method Warning only professional personnel verified by the manufacturer can repair this instrument 49 Auto Hematology Analyzer User s Manual Appendix Name and concentration of toxic and 20 hazardous substance or element in product Toxic hazardous substance or element Component name l Hexavalent Polybrominated Lead Mercury Cadmium ROI Polybrominated diphenyl ethers Pb Hg Cd Cr VD biphenyls PBB PBDE Display screen Optoelectric component Ancillary part contents of this toxic hazardous substance in all homogenous material of the component are below limit stated as per SJ T11363 2006 standard content of this toxic hazardous substance at least in one homogenous material of the component is out of limit stated as per SJ T 11363 2006 standard Note for various versions of instrument configuration may vary slightly these variations are done without prejudice to instrument performance and use please rest assured to use 50
23. bution QC chart of each parameter is composed of X chart and R chart reflecting QC data mean and range fluctuation respectively Three values on the left of X chart are from top to bottom XY LAR Y X A R respectively Three values on the left of R chart are from top to bottom D R R M k D R respectively where X X K X is mean value of group i R 2 R K KIS 1 the difference between maximum and minimum of group i K is subgroup quantity A D D are coefficients determined by number of samples in each group Press t keys on keyboard or frame to switch between parameters Press gt keys on keyboard or frame to display QC data of various sequence numbers Press Print button to print out one current group of QC data 28 Auto Hematology Analyzer User s Manual 5 Calibration Before delivery all instruments have been subjected to strict test and calibration But during transportation and using test result may drift due to different reasons instrument calibration purpose is to ensure test result accuracy In order to guarantee instrument test accuracy and get stable and reliable test result instrument must be calibrated in following cases 1 First installation for use and reinstallation at other place 2 Instrument has been repaired 3 Deviations in QC results Note calibration sample shall adopt The manufacturer designated commercial calibration
24. ch are whole blood anticoagulant peripheral blood and pre diluted peripheral blood If select pre diluted peripheral blood mode first add 20ul peripheral blood at the diluting cup then click Diluent button a message box as following will appear Put the tube under the sampling needle press aspirate key to add diluent Fig 3 5 Add diluent Press the aspiration key will add 700ul diluent to the diluting cup to complete the dilution out of instrument the analyzer will aspirate 300ul diluentd sample for counting The test procedures are as following 1 Put sample cup under sampling needle press aspiration key the instrument aspirate blood sample wait until sampling needle rises inside instrument remove sample cup 2 Instrument begins to analyze sample frame top message box shows Being tested after test parameter test result and histogram will be shown as follows 17 Auto Hematology Analyzer User s Manual Wnole blood A 9 2019 Current 1 Name 1 2 12 Sex Age WBC 6 03 x 10 9 L LYM 2 84 X 10 9 L MID 0 43 x 10 9 L GRA 2 76 X 10 9 L LYM 47 10 j 50 100 150 200 250 300 250 MID 7 19 GRA 45 71 RBC 4 43 X 10 121L HGB 145 gil MCHC 330 30 g L MCH 32 73 pg MCV 91 45 fL RDW CY 12 88 RDW SD 41 26 fL HCT 40 51 PLT 219 x 10 9 L MPY 9 32 fL PDW 14 91 PCT 0 22 P LCR 38 53 Diluent L Adjust G Profile D Print P Help H Confirm C He Test
25. d the corresponding column shall be blank Send function can transfer part or all of the L J QC data to external equipment Use mouse or touch pen to click list column select one group of QC data Using keyboard Ctrl key or Shift key multiple columns can be selected You can send all data click Send button open transfer dialog box as follows Selected Data C All Data Send S Fig 4 5 L J data transfer Select data to be submitted click Send Click Delete button then delete confirmation dialog box pops up after confirmed you can delete part of or all QC data Selection method of part of data is the same as data transfer 4 1 4 L J QC chart QC chart displays QC data distribution in graphs to facilitate understanding of instrument deviation trend In main screen select QC file open QC chart screen as follows Lal GC Graphit 1 T Let iad Expiry 7000 12 31 Time 0074 15 75 55 eg 1 wae 10 Mean 3 65 Die 89 90 fi 3 7 2 4 Ce 0 90 roc ATi Mean 4 31 TH 4 21 Di 0 13 ERA CAE 4 31 GB 121 KA Mean 113 9 L La U 115 00 111 4 my Din 4 51 101 CY 336 T 298 Mean 274 3 230 00 Tb DIR 8 32 250 CW J 4 F 4 p pani ea Het Sl rnd Fig 4 6 L J QC chart 23 Auto Hematology Analyzer User s Manual Lot No lot Number of QC sample corresponding to QC file Expiry validity period of QC sample Time test time of datum corresponding to QC point Seq sequence number of
26. d under atmospheric pressure anticoagulant must be dropped to all venous blood collection containers in advance usually EDTA K2 2H20 is adopted as anticoagulant with content of 1 5 2 2mg ml 3 3 2 Peripheral blood collection e Blood sampling position For adults the inner side of middle finger or ring finger tips of left hand is better for children above half a year old middle finger is better for infant below half a year old blood is usually sampled from thumb or outer side of foot bottom e Blood sampling method It shall be carried out in accordance with peripheral blood collection standard of health authority Peripheral blood collection normally adopts local centesis the typical collection method is to pierce through finger end Blood tube uses 20uL constant volume blood tube or bullet blood tube It is recommended to collect no less than 30uL blood to facilitate double check During blood sampling if blood flow stagnates one may slightly press farther end of wound never force around piercing hole Avoid tissue fluid mixed with blood hampering test analysis result accuracy 3 3 3 Blood sample mixing Before test blood sample must be thoroughly shaken and mixed the recommended method is shake up and down rotate test tube 3 5min do not shake too violently Blood sample to be tested can only stored at room temperature test shall be done in 4h 15 Auto Hematology Analyzer User s Manual prolonged storage or inferior
27. egative pressure of pressure syringe Solenoid valve 3 to control WBC chamber cleanser adding during rinsing Solenoid valve 4 to drain pressure syringe Solenoid valve 5 to provide negative pressure needed by WBC and RBC chambers Solenoid valve 6 to control RBC chamber diluent adding during rinsing Solenoid valve 7 to control diluent and air aspiration in sampling needle flushing unit Solenoid valve 8 to control diluent in sampling needle unit Solenoid valve 9 to control diluent dispensing Solenoid valve 10 to control WBC chamber draining Solenoid valve 11 to control RBC chamber draining 10 2 10 Debug For the engineer to test and debug the instrument 10 2 11 Egineering This function sets up system parameters These settings will have direct impact on test result before modification please confirm its necessity normal users have no priority to modify unless logging on with administrator account see detail operation in Chapter 7 System Setting Warning engineers not trained by The manufacturer Company are refrained from using this function otherwise test result accuracy will be affected or even normal test can not be performed 10 2 12 Machine reset When mechanical component is out of step you can restore original status with mechanical reset 47 Auto Hematology Analyzer User s Manual 10 2 13 Stop use If the instrument will not be used for more than two weeks or to be packed for transportation
28. ent fat corrosive substance to clean instrument 10 2 Maintenance program 10 2 1 Back flush Back flush gem hole together with the function of Burn to prevent and eliminate jam of hole 10 2 2 Burn This function is to burn the gem hole to prevent and eliminate jam of hole 10 2 3 Drain chambers Drain off the diluent in WBC and RBC chamber 10 2 4 Drain pipeline Drain off liquid in the pipeline 10 2 5 Remove Blockage Particular procedure to eliminate the blockage of hole 45 Auto Hematology Analyzer User s Manual 10 2 6 Prime System will prime automatically during sample test If you have performed drain operation or replaced reagent you shall perform the operation of priming 1 All reagents fill diluent lyse and cleanser into related pipeline 2 Diluent fill diluent into related pipeline 3 Lyse solution fill lyse solution into related pipeline 4 Cleanser fill cleanser into related pipeline 10 2 7 Cleaning When you think that the chamber has been polluted or the blank test result keeps unacceptable you shall use this function 10 2 8 Concentrated cleanser soaking Concentrated cleanser is an alkalescent wash solution It is used for cleaning pipeline and chamber At the service menu click Bougie Fluid to perform the concentrated cleanser soaking procedure When the system give the message to add concentrated cleanser add it manually into the chamber You shall perform this operation
29. equirement the operator may adjust histogram Procedure is as follows 1 In sample test menu click Adjust button histogram selection frame pops up as shown below f WBC RBC C PLT See OK Cancel Fig 3 7 Histogram selection Select histogram to adjust click OK to return click Cancel then no histogram will be chosen To adjust histogram without external keyboard click 8 to open soft keyboard 2 Use mouse or keyboard number key 1 2 3 to choose type line press lt to move left to move right Meanwhile current volume is shown on left move type line WBC diagram has only 2 sign lines to adjust both sign lines of RBC and PLT can be adjusted 3 After adjustment click OK button confirmation frame will pop up as below E x 7 Save the changes OK Cancel Fig 3 8 Adjust confirmation 19 Auto Hematology Analyzer User s Manual Click OK button to save adjust result click Cancel button to cancel this adjustment result 3 4 6 Print Before sample test please set up printer and print format in system setting module see detail in Chapter 7 System Setting Click Print to print this test result Warning during test please do not replace reagent 20 Auto Hematology Analyzer User s Manual 4 Quality Control Quality control reflects system accuracy and repeatability Available instrument quality control prog
30. eter test result is less or equal to maximum pathogenic value greater than maximum of normal value L indicates that parameter test result is greater or equal to minimum of pathogenic value 18 Auto Hematology Analyzer User s Manual less than minimum of normal value 3 4 4 Histogram prompt message LF1 prompts that region on the left side of lymphocyte peak is abnormal possibly because of platelet coagulation giant platelet plasmodium nucleated red blood cell non lysed red blood cell abnormal lymphocyte cryoglobulin LF2 prompts that lymphocyte peak and intermediate cell region are abnormal possibly because of heteromorphic lymphocyte plasma cell atypical cell initial cell eosinophils and basophiles population LF3 prompts that the region between intermediate cell area and neutrophil peak is abnormal possibly because of immature granulocyte abnormal cell and eosinophils LF4 the region on the right side of neutrophil is abnormal possibly because of granulocytosis PF1 the region on the right side of platelet is abnormal indicating probable existence of large platelet platelet aggregate small red blood cell cell fragment and fibrous protein PF2 the region on the left side of platelet is abnormal indicating probable existence of small platelet cell fragment red blood cell inclusion body and electronic noise interference 3 4 5 Adjust histogram When WBC RBC PLT automatic classification result fails to meet r
31. ey may be different form the actual display please according to the actual display Unless been authorised by the manufacturer No person or orgnization has the right to copy modify or translate this user s manual Only that all the following requirements are met The manufacturer will be responsible for the safty reliability and performance of the product O Install adjust update and repaire are done by The manufacturer authorised person O Operation of instrument followed the user s manual strictlly e Electric environmentmeet the requirements Note e This instrument shall be operated by prefessional of medical inspection or trained doctor nurse and experimentalist Warning e f the orgnization which are using this instrument can not finish a satisfactory maintenance repair plan for the instrument it may cause abnomal fault to the anlyzer even endanger the health of operator e The analyzer must be operated under the stated conditions if not it may cause abnormal running of instrument the test results may be not reliable also it can break the parts of analyzer even endanger the health of operator Auto Hematology Analyzer User s Manual Main graphical representations used on this instrument Temperature limitation Fragile articles The fragile articles are contained in the transport package so it should be handled with care when being transported Upwards It indicates that the transport package shall be kept vertica
32. f year is available then month and day will not be saved if month is available the days will not be saved Age range is 1 150 month range is 1 30 day range is 1 90 gt Sample type anti coagulating whole blood anti coagulating peripheral blood and pre diluted peripheral blood can be chosen gt Reference general male adult male female 16 18 years 6 15 years 3 5 years 3 months 2 years 8 days 2 months the 1 week and user define value can be selected The default is general gt Medical No patient medical record no gt Bed No number of sick bed of patient gt Department sender analyst and checker directly input or select from dropdown box please see detail setting in Chapter 7 system setting Click ES to open soft keyboard as shown below 16 Auto Hematology Analyzer User s Manual Fig 3 4 System soft keyboard When soft keyboard is used the cursor has to be moved into input box then click to input Caps is to toggle between uppercase and lowercase click Close to close soft keyboard Soft keyboards in other frames are used likely Click OK button system will update or save sample data click Cancel button return to sample test screen 3 4 2 Blood sample counting You can select blood type by Mode button or select form the box at sample data edit menu There are three kind of blood type for selection whi
33. g L 16 18 years GRA 2 7 8 Xx 10 9L MCH 26 5 33 5 pg LYM 21 MCV 80 97 C 6 15 years ER RU fL MID 1 15 RDWw cy 10 15 3 5 years GRA 40 70 RDW SD 35 56 fL 30 50 C 3 months 2 years pir 100 300 Xx 10 9 L MES C 8 days 2 months MPY 11 fL PDW 10 18 C First week PCT 0 1 0 5 C User defined P LCR 13 43 o ee Save S Help H Back X Fig 7 5 Normal value setting Reference range of each parameter has been set before delivery of instrument to modify parameter reference range you can select blood type and population category and fill in parameter lower limit and upper limit blanks click Save button 7 2 3 Panic limits When parameter value exceeds normal value range it does not definitely indicate that the subject is patient when it falls within panic limits the conclusion has to be made on specific case Click Panic limits button open setting menu as follows 38 Auto Hematology Analyzer User s Manual Blood Type Whole blood C Peripheral blood C Pre dilute peripheral blood Targets Limits General Item Low High Item Low High i e 2 5 7 C Adult male WBC 2 15 lt 10 9 L RBC Xx 10 12 L LYM 0 4 6 lt 10 9 L HGB 30 180 giL C Adult fmale MID 0 05 2 5 x 10 9 L MCHC 280 450 g L C 16 18 years GRA 1 10 X 10 9 L MCH 20 40 pg LYM MCV 70 110 n 6 15 years ble Bo l MID 0 5 25 RDW C 5 20 C
34. hown below No Targets Limas 1 2 3 4 5 B Bae 2008 07 03 20080703 2080703 20080703 2080703 2068 07 03 Time 09 2821 101235 103845 1033 45 10 38 45 103345 WBC 33 U 40 9 70 9 SU 55 300 9 Bu 3g CMR 10 32 132 451 451 12 4 42 12 Mme 070 0720 04 05 D 49 049 0 49 Ds GRAF 470 080 4065 510 512 512 517 512 LM 4470 10 00 4574 4395 4317 4317 ov 4317 MOS 16 60 5 00 4 94 5 60 498 4 99 459 a3 GRA 48 50 8 00 49 32 50 45 51 86 51 05 51 65 5195 RBC 14 29 0 15 424 4 46 143 130 143 143 RGB Ww LULU 5 tt 128 Jo 1 AU 1 32 Uy 1 Je YU 1 32 UU ett MCHC 344 00 30 00 408 07 311256 39 13 369 13 39 13 39 13 MH 2m 200 68 NA m4 met 41 1 41 MEN las 6 00 9 8 96 p a w a ROWECY 1300 5 00 113 11 17 123 1123 1123 ROW SD 13 50 39 31 39 0 6 3 33 1 MTT 1 00 4 43 94 PLT 1 AU 00 I 205 00 b gt 00 hS MPV j 150 4 4 i POW 16 00 y 1 1 PET L 14 PLOR 1 4 431 HRS t Fig 4 8 X B QC list The instrument displays 20 parameter QC result if some parameters are not controlled the corresponding column shall be blank Upper limit of QC data columns of X B QC list shown at a time is 200 if data are more than 200 columns they can be viewed by switching using LT and IL Sending function can transfer some or all X B QC data to external equipment Operation method is the same as data transfer in 4 1 3 L J QC list In list frame click Delete button delete confirmation dialog box pops up After confirmed some or
35. ive parts For safety purpose users are not allowed to refit the instrument Auto Hematology Analyzer User s Manual Contents Main graphical representations used on this instrument 3 Warnings and security attentions ce e e e e e e eee 3 1 Instrument IntroductiON oocococcnnnccninnoccncnnnnonnnnononnnnonancnnonannnnonanannns 9 11 ProquetintoduUclONasrioinsis ias aia 9 1 1 1 Product name Auto Hematology ANalyZer coocccocccococoncnoncoconococononcnoncnnononaconanons 9 A A A LEE ny TE REE TE 9 1 2 Product technical parameters eee ee e eee ee 9 1 3 Instrument composition and Structure eee eee ee eee e ee 9 Wal PLONE VS Wii iia 10 ESA A ee ee 10 SEU APPO ee e A A 12 Z I Tena Ini p Bare aT ies aia e oia 12 2 2 Installation ENVIFONMENL cece cc cec aa A a 12 2 O OWE so WE pao y PPP CNO O 12 2 4 Reagent CA nn 13 2 4 1 Connection of Lyse and Cleanser eee eee ee 13 242 ONNESCHON Ol dilden anita od 13 243 GONNECION Ol Waste ii odo ebeen dt 13 2 5 Connection of keyboard mouse eee eee ee 13 2 6 Connection of external printer ooccoccconcocnconconconncononcnconconoononanoncononnnns 13 SP sas aaasahiate aan 14 3 1 Preparation before Startup e ee ee eee e 14 K R Ani o E EEEE ncaa naun nei naan A A E E E ouabaneue 14 3 3 BIOOd Sample CONC CON sterre n T E 15 3 09 VENOUS DIOOG CONCCUON iii aia 15 LoL F ClIDMeral DIOGO CONECO T 15 3 9 9 Sele e Sample MANI
36. le colorimetry for hemoglobin measurement to categorize and count blood cells in blood Test items are shown in Table 1 1 Table 1 1 Intermediate cells percentage MID Granulocyte Cells percentage GRA Redbloodcellcount RBG TO oo h Hematocrit Mean corpuscular volume Mean corpuscular hemoglobin Mean corpuscular hemoglobin MCHC concentration Red cell distribution width SD RDW SD Red cell distribution width CV RDW CV a ee Platelet count 10 L Mean platelet volume Platelet distribution width Plateletcrit Platelet large cell ratio P LCR White blood cell histogram WBC Histogram A Red blood cell histogram RBC Histogram El Platelet histogram PLT Histogram LO i y Ol 1 2 Product technical parameters Test principle WBC RBC PLT Impedance method HGB colorimetry Aspiration volume 9 8uL Whole Blood 9 8uL Anticoagulant Peripheral Blood 20uL Pre diluted Peripheral Blood Test rate About 1 min ea Working environment 15 C 35 C relative humidity 10 90 Store environment 0 C 40 C relative humidity lt 80 Power supply a c 110V 220V 50 60Hz Input power 96VA 1 3 Instrument composition and structure The analyzer is composed of chamber tubing system computer control system and software Auto Hematology Analyzer User s Manual 1 3 1 Front view D S O 9 D Fig 1 1 Front view Display screen Display the software interface Indicator light yellow at startup turn
37. lly upward To be protected from rain The packaging piece is extensive to the rain Limit of the number of stacking tiers It indicates the maximum number of the stacking tiers of the same package 3 indicate the limit of the stacking tiers Biological risks 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 SN Serial number IVD In vitro diagnostic medical device Manufacturer Authorised representative in the european community Warnings and security attentions Auto Hematology Analyzer User s Manual This instrument is only provided for in vitro diagnosis please carefully read the following warnings before use They are required to be strictly followed Warning please carefully read the following security attentions before use this instrument If the smoke peculiar smell and sound appears while using the power supply must be immediately cut off Meanwhile the inspection apply shall be immediately presented towards the distributors or agents of The manufacturer If the instrument continues to be used under this circumstance the misfire electric shock or casualties of personnel might be caused The bloods reagents and metal pieces shall be avoided from entering the interior of this instrument or the short circuit or misfire with smoke generation will be caused lf abnormality happens the power
38. lution check if instrument is powered on check if power plug gets loose or falls off check voltage check instrument power is connected or not check power cable is loose or not power off instrument internal circuit breaker and restart replace diluent from main screen maintenance menu select reagent filling gt diluent replace cleanser from main screen maintenance menu select reagent filling gt cleanser replace Lyse from main screen maintenance menu select reagent filling gt lysis solution discard waste in software main menu click System Info gt System Status check environment temperature if not within 15 C 35 C range restore instrument ambient temperature to this range reagent is used up or not reagent is deteriorated or contaminated calibrate instrument check temperature or pressure if it is normal calibrate instrument check if sampling needle location is right check if there is bubble in fluid syringe piston slides smoothly If there is bubble please make sure that reagent tubing connection is normal check solenoid valves if they work normally check printer if there is no paper check if normally connected check printer setting in system setting check reagent validity period check setting if it is right and necessary to modify parameter make sure that QC process is not cont
39. m buttons to check sample To adjust histogram run as per 3 4 5 To modify sample basic message click Data button go to Data Edit menu see detail in 3 4 1 Sample data edit In sample history data menu click Print button the instrument will print out current sample history data according to system setting print mode See print setting in Chapter 7 System Setting 35 Auto Hematology Analyzer User s Manual 7 System Setting System setting is used to set up system parameters in main screen click Setting and go to System Setting menu as follows Serial Number 2008081 8001 Print Time Printer C Internal Printer External Printer T Print instantly inti 2008 111 04 a Print items Set Printer properties T M D 15 M 17 06 External Printer HP LaserJet 1022 lt d s Printout HALF PAGE WITH HISTOGRAMS Hospital Special Startup Blank Test Clean Freq times 60 T Pre diluted test mode inform Y Transmit instantly a M Save S 4 Other 0 o Help H Barun Exit Fig 7 1 System setting 7 1 General setting gt gt Serial number machine serial number used to identify one instrument Time input or use adjust bar on the right to modify setting item set up new time only after saving Language used to switch between different system languages If one wishes to still use current setting after next startup please save language se
40. mixing will influence test result accuracy 3 4 Blood sample analysis Prior to sample analysis it is recommended to take one QC test of instrument see detail operation in Chapter 4 Quality Control Warning instrument test object is blood sample suction of other substance may lead to instrument malfunction 3 4 1 Sample data edit In sample analysis you can modify sample no or input sample data before test Modification after test has to be done in History Data module see detail operation in Chapter 6 History Data Click Profile button Data Edit menu pops out as follows Sample proie Sample No 20080512001 Name Po Sex Age 30 2 Years po 4 Months 0 Days Blood Type Whole blood y Reference General y Medical No Po Bed No pO Department po Sender po Analyst po Checker po Fig 3 3 Sample data entry gt Sample No to modify sample no please input 11 digit number in sample no box according to format of year month day 3 digit sequence number If this sample No has existed in system then the user will be asked to use new sample no Otherwise the system will cover the existed test results The system will create sample number for 001 everyday according to the test date gt Name maximal 20 letters gt Sex male or female may be selected if no chosen the system default is blank gt Age for Year Month and Day just input one number If multiple items are input then i
41. mple gt Calibration parameter parameter to calibrate Click Delete button current calibration sample setting data can be deleted Click OK to save current lot number data and exit Click Cancel button the system will not function and directly return to Auto calibration running screen After setting return to screen as shown in Fig 5 2 start calibration test the process is as follows 31 N Eh Ww ee e Nr wo 9 Auto Hematology Analyzer User s Manual Have calibration sample ready press Aspiration key to start test After test calibration result will be shown in current test number column Repeat test the instrument allows 20 runs at most Statistic results and new calibration coefficient will be shown in table below frame after each test automatically Unsatisfactory test data rows can be deleted at any time If deciding to use new calibration coefficient click Save button the system will save new calibration coefficient 32 Auto Hematology Analyzer User s Manual 6 Results After test of each sample the system automatically saves test data parameter test values and histograms of at most 50000 samples User can check parameter test data and histograms of all samples print delete modify and retrieve sample data of designated condition In main screen click RESULTS button open history data list menu as shown below 20080505009 20080505010 20080505011 200805050
42. nction data selecting methods a use select function b Use mouse or touch pen to click list column select one history data using keyboard Ctrl key 33 Auto Hematology Analyzer User s Manual or Shift key you can select multiple columns If no data are selected all data can be sent Click Send button open transfer dialog box as follows Selected Data All Data Send S Exit Fig 6 3 Data transfer Select data to send click send Locate Locate function is used to jump to designated record location click Locate button open locating dialog box as follows Position OK Cancel Fig 6 4 Locating dialog box Input a number ranged between 1 and 500 into position box click OK Click Cancel to exit directly Search Search function allows user to search required record according to designated condition click Search button open search dialog box as follows A No Po Name f Sex y Medical No BedNo Department lt Start Date zjy ul zip EndDate Sw Mai zip E Cancel C Fig 6 5 Search condition Sample no is the only identification of history record If input sample no other conditions are disabled User can use one or multiple condition to retrieve input message click OK if there is compliant record it will be shown in history record list If there is no compliant record the system will give a message
43. ns are touched with the reagents they shall be immediately washed to be clean using a large amount of clear water The waste products such as used test tubes other instruments and consumables 4 Auto Hematology Analyzer User s Manual etc shall be appropriately handled as the medical waste products or infectious waste products If the pollution is caused by bloods the infection might be generated by pathogens O Take proper protection while replacing reagent Voltage connection and grounding of power supply The power supply and grounding environment of this instrument are assured to be good and stable The plug of the power supply shall not be inserted into the power socket which is not available for the voltage requirement stated in the backplate of instrument or the misfire or electric shock might be caused When the instrument is installed the power supply cable and adapter as accessories attached to the machine must be used and the good grounding shall be assured or the misfire or electric shock might be caused DO NOT damage the insulation protection skins of the power cord DO NOT pull the power cord with efforts or hang heavy articles on it or the short circuit or open circuit might be caused When the peripherals are connected the power supply must be first cut off or the short circuit or open circuit might be caused Do not open the side cover or panel while instrument is on all it may cause damage to some sensit
44. nser respectively open the bottle lids and place them in instrument reagent booth horizontally 2 Insert plastic tube marked Lyse into the Lyse bottle and tighten the bottle cap 3 Insert plastic tube marked cleanser into the cleanser bottle and tighten the bottle cap 2 4 2 Connection of diluent 1 Take out diluent catheter from the accessories bag 2 Connect diluent catheter end to Diluent route adapter on rear panel of instrument 3 Insert the other end of catheter into diluent bottle and tighten the bottle cap 2 4 3 Connection of waste 1 Take out waste catheter from accessories bag 2 Connect waste catheter end to Waste route adapter on rear panel of instrument 3 Clockwise rotate the bottle cap with waste catheter to tighten it on the waste bottle Note 1 Reagent tubing must not be twisted folded or rotated by force 2 Please do not use expired reagent 3 The waste must be treated in accordance with related national regulations wear rubber gloves when disposing of waste 2 5 Connection of keyboard mouse 1 Carefully take out keyboard and mouse from packing carton 2 Carefully insert keyboard cable plug into socket marked Keyboard on instrument rear panel 3 Carefully insert mouse cable plug into socket marked Mouse on instrument rear panel 2 6 Connection of external printer 1 Make sure both printer and instrument have been shut down 2 Insert one end of USB cable into printer
45. ower off prompt then instrument power can be switched off Warning never turn off power directly without running shutdown program 44 Auto Hematology Analyzer User s Manual 10 Service Fully automatic Hematology Analyzer is a clinical precision analyzer in order to maintain good instrument condition get reliable test result and reduce instrument fault rate the instrument shall be maintained routinely this chapter introduces related maintenance operation Warning please perform maintenance operation according to user s manual and service manual otherwise it may cause instrument damage 10 1 Routine maintenance 10 1 1 Startup and shutdown process At startup the instrument will run mechanical component test and blank test for user to discover problem as early as possible While running shutdown operation daily shutdown maintenance program will be automatically performed After shutting off instrument power just clean workbench and instrument surface 10 1 2 Automatic rinse If number of samples instrument tests has reached the number preset by user then the instrument will run automatic rinse program User can adjust automatic rinse frequency at will Refer to Chapter 7 System Setting Rinse can also be done in Maintenance menu 10 1 3 Clean instrument surface Keep instrument working environment clean Instrument surface can be cleaned with neutral detergent and wet cloth Warning do not use any solv
46. please conduct in following steps a In Service menu select Stop Use complete operations according to the message given by system when screen displays it s ready to shut down shut off instrument power b For the remaining diluent cleanser Lyse cover the bottles and turn tight store as per reagent instruction c Power cables and adapters are to be cleaned with clean cloth dipped with neutral detergent put in cool place let dry and pack in plastic bags d Put instrument and plastic bag packed components in instrument packing carton 10 2 14 Replace reagent In order to make the system monitoring the using of reagent when you are replacing the reagent please input the volume of reagent you replaced in System will record this volume and monitor the using of reagent when the remaining volume is not enough it will give a message 48 11 Troubleshooting Auto Hematology Analyzer User s Manual This chapter describes common faults of instrument and their solutions if failing to eliminate faults as per tips in this chapter or needing more detailed data please contact the manufacturer customer service department Fault 1 Instrument cannot be started up Instrument cuts power automatically No diluent No cleanser No Lyse Waste bottle full Temperature abnormal Blank counting value higher repeatedly Parameter test incorrect 10 Printer cannot print 10 QC not in target range So
47. ram provides reliable and efficient way to check and prevent possible system error lf there is system error sample analysis result will be unreliable To maintain accurate analysis result discover and eliminate instrument measurement system error in time it is recommended to make regular quality control of instrument provides three QC methods L J QC X B QC and X R QC 4 1 L J QC In main screen click QC button choose 20 QC files of L J QC The system can control 20 parameters at a time L J QC uses QC samples for QC analysis 4 1 1 L J QC setting nnn Control No acil A S 5 C oc Lot EX Expiry 2008 y 12 3 NIS 0 E C 0C 3 C r de Item Targets Limits Item Targets Limits C ACE WBC 9 70 0 30 lt 10 9 L RBC 4 21 0 50 Xx 10 12 L COC LYM 4 30 0 30 Xx 10 9 L HGB 111 00 10 00 gil C ace MID 0 70 0 30 x10 9 L MCHC 34 40 2 00 gil C 0C 9 i C 0C 10 ill 0 30 x10 9L MCH pg c 0C 11 LYM 44 70 2 00 MCV 84 30 0 80 fL C ac 12 MID 7 00 3 00 RDW CY 0013 GRA 48 50 3 00 RDW SD fL Paes 35 50 3 00 Cac 15 per 278 00 20 00 xma HOT gt gt i r QC 16 MPY fL mo Poy 15 00 3 00 Ed 0 10 0 10 racia PCT E 0 C 0C 20 P LCR 0 22 0 10 Move Sr ll a owen y o oo Fig 4 1 L J QC setting Oo Save select QC file enter lot No validity period parameter targets value and limits click save button save QC data
48. red when starting sample test turn yellow after test Feed key built in printer feeds paper outward Aspiration key in sample analysis press this key the instrument will aspirate sample Printer cover print paperinstalling position for built in printer Sampling needle use sampling needle to aspirate sample into chamber Aspiration key in sample analysis press this key the instrument will aspirate sample 00566 00 function the same as key 1 3 2 Rear view NT 12 L EF II TTT Od 6 oe 00 YF G E Fig 1 2 Rear view 1 Rear cover switch turn this button open the rear cover to replace reagent 2 Keyboard interface PS 2 keyboard interface 3 Mouse interface PS 2 mouse interface 4 USB port 10 Auto Hematology Analyzer User s Manual 5 RS 232 serial port to connect with data receiving devices 6 Network interface 7 Power interface to connect with external power supply 8 Power switch switch instrument power 9 Diluent sensor 10 Grounding hole used for instrument grounding 1 Cleanser sensor 12 Cleanser port 13 Diluent port 14 Waste port 11 Auto Hematology Analyzer User s Manual 2 Installation 2 1 Instrument unpacking 1 Unpack the instrument s package and remove material for transportation Please keep original packing carton and packing material in case you need to repack the instrument in the future 2 Take out the instrument from plastic package
49. rrent coef Calib Date BC 100 100 00 2009 03 25 ADW SD 100 100 00 2009 03 25 RBC 100 2 100 00 a 2009 03 25 PLT 100 2 100 00 2009 03 25 HGB 100 100 00 lt s 2009 03 25 mpy 100 100 00 g 2009 03 25 MCV 100 100 00 2009 03 25 PDW 100 100 00 2009 03 25 RDW C 100 100 00 7 2009 03 25 P LCOR 100 100 00 S 2009 03 25 Fig 5 1 Manual calibration Manual calibration procedure is as follows 1 In Sample Test menu use calibration sample to test several times at least three 2 Record the tested data 3 Calculate new calibration coefficient Calculate new calibration coefficient as per formula below current _ calibration _ coefficient x calibration _ sample _ reference _ value new _ calibration _ coefficient Mean _ of _ test _ values 4 In Manual Calibration screen select sample type input new calibration coefficient in calibration input box input calibration time in calibration time box If running auto calibration the parameter calibration time will be automatically updated to the time of automatic calibration 5 Click Save button to save current calibration result Click Exit button the system will not save result and directly return to main screen 5 3 Auto calibration When automatic calibration is selected after testing calibration sample the instrument can automatically calculate new calibration coefficient Auto calibration procedure is as follows 1 Setup c
50. sample stores and uses as required Before making sure that all calibrations have been done correctly do not use test results for medical and clinical diagnosis 5 1 Preparation before calibration Commercial calibration sample can be used to calibrate this instrument All mathematic calculations related with calibration can be done by instrument automatically calibration coefficient is automatically saved has three sets of calibration coefficients anti coagulating whole blood anti coagulating peripheral blood and pre diluted peripheral blood anti coagulating whole blood anti coagulating peripheral blood and pre diluted peripheral blood are calibrated separately Before instrument calibration you shall check in following steps make sure machine works in normal status if any problem is found stop calibration 1 Check instrument and reagent make sure that instrument is in normal status reagent is sufficient material needed is complete 2 Make blank test make sure that blank test value meets requirement 3 In counting screen use median blood sample to repeat test make sure that instrument works within precision range 5 2 Manual calibration In main screen select manual calibration the system goes to manual calibration screen as shown below 29 Auto Hematology Analyzer User s Manual sample Type a Whole blood t Peripheral blood t Pre diluted peripheral blood ltem Default Current coef Calib Date Item Default Cu
51. system status The system provides two test parameters now if test value is out of reference range related troubleshooting is necessary 8 2 System log System log records main events and results of instrument during running In system info menu of main screen click Log go to system log frame you can check log message as follows Dae Time Event resm O O Exit X Fig 8 2 System log 8 3 Statistic information Statistic information includes instrument running time after startup and total instrument 42 Auto Hematology Analyzer User s Manual running time in system message menu of main screen click Statistic it will go to statistic information menu as below Statistic information Running time since startup 9 Hours 12 Minutes Total running time 0 Hours 12 Minutes Tested samples today 0 Total samples tested 1 Fig 8 3 Statistic information 43 Auto Hematology Analyzer User s Manual 9 Shutdown After work every day you must run shutdown program before turning off instrument power During shutdown the instrument will perform routine maintenance and rinse test tubing In main screen click Shut down button the system will pop up confirmation dialog box as below A gt 2 Are wou sure to shutdowr E Lancel Fig 9 1 Shut down confirmation Click OK the system runs shutdown program after running the instrument screen will display Please p
52. ther Click Other button open the menu as follows R Dept Info Doctor Info Back Fig 7 2 Other setting 7 2 1 User setting The system has three levels of users now system administrator advanced user and common user with varied priorities Default is common user then some settings are disabled to enable these settings please click Log on button open logon dialog box as follows Name admin Password e Fig 7 3 Logon dialog box Select or input user account and password click OK button if you re system administrator then all functions in Other Setting screen will be enabled System presets administrator user Admin the password is 1008 A few version s password is 7600 New menu after system administrator logon is as follows 37 Auto Hematology Analyzer User s Manual Normal Limits Panic Limits Units came Dept Info Doctor Info User Manage Log Off Back Fig 7 4 Other setting Click Log off button the user identity will be changed to common user 7 2 2 Normal limits Click Normal Limits button open setting menu as follows Blood Type Whole blood C Peripheral blood C Pre dilute peripheral blood Targets Limits General Item Low High Item Low High A 3 8 5 8 C Adult male WBC A 10 x10 9 L RBC X 10 12 L LYM 0 6 4 1 x10 9L HGB 7110 165 g L C Adult fmale MID 0 1 1 8 10 97 MCHC 320 360
53. tting Print setting 1 Printer select internal Print the instrument s internal thermal printer will output result Meanwhile you can select Print instantly or not if selecting Print instantly the test result will be automatically printed once the sample test ends Select External Print the system will print by external printer selected 2 Print item click Set button to open the print item setting menu you can select the parameters need printing The system provides 3 templates for user 3 Printout internal printer has 2 formats with histogram without histogram Parameter names refer to name of 20 hematology parameters With histogram means printout includes histogram without histogram means printout does not include histogram 4 Unit name will be printed in report title Special 1 Startup blank test select startup blank test then start up program for blank test otherwise skip blank test 2 Clean Freq times in this box input test sample quantity when instrument tested sample number is above this value the instrument will run cleaning procedure one 36 Auto Hematology Analyzer User s Manual time If it is set zero it will not execute automatic cleaning 3 Pre diluted test mode inform select the box before pre diluted peripheral blood test inform message will popup 4 Transmit instantly After sample test the result will transfer to the computer by RS 232 serial port synchronously 7 2 O
54. up gay E savers gy send A one Help a Exit Fig 4 10 X R QC setting Lot No lot number of QC object Expiry validity period of QC object Group No 2 60 default is 20 Number of samples in each group 2 10 default is 5 Save select QC file input lot No validity period and parameter target value and limits click Save button to save QC data of current QC file if this QC file has data then update Delete delete QC data of currently selected QC file Send use instrument RS 232 serial port to transfer QC data of currently selected QC file to designated receiver Before sending please connect to equipment to receive data with RS 232 serial port cable start up and set up receiver software parameters For instrument transfer terminal parameter setting please refer to Chapter 7 System Setting Help to display system help Exit return to main screen 4 3 2 X R QC run After QC parameter setting of selected QC file QC analysis of this QC file can begin In main screen select QC file go to QC run screen as shown below 26 Auto Hematology Analyzer User s Manual Expiry 2000 11 01 ji JAE B Bene OX Delete led aun A nackpa Fig 4 11 X R QC run 1 Have QC sample ready press Aspiration key to start test 2 After test QC results will be shown under current QC number column If there is fault alarm in test this test result may be inaccurate You can click

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