Hemo3PC60 Auto Hematology Analyzer User's Manual
Contents
1. 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 l n current calibration coefficient x calibration sample reference value new calibration coefficient M Mean of test values 4 n 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 calibration sample select parameters to calibrate 2 Test calibration sample 3 Determine calibration coefficient Auto calibration screen is as follows 3l Hermo3PC60 Auto Hematology Analyzer User s Manual Lot ZNDJFJI98 Validity 2009 09 01 Whole blood RDW Cv RDW SD PLT 4 21 122 00 84 30 13 00 40 00 278 00 8 50 16 00 30 00 100 00 1002. ee Fig 7 8 Communication 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 41 Hermo3PC60 Auto Hematology Analyzer User s Manual 8 User Identity 8 1 User Logon The system has two levels of users now system administrator 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 User Logon Name Admin hd Password Fig 8 1 Logon dialog box Select or input user account and password click OK button if you re system administrator then all functions in Advanced Setting screen will be enabled System presets administrator user Admin the password is 1008 8 2 User Logoff On main menu click User Identity key then click Log off key the user identity will be changed to common user 42 Hermo3PC60 Auto Hematology Analyzer User s Manual 9 System Information oystem message provides several types of message about system user can check system status through system message function module 9 1 System status On system message menu of main screen click Information key then click system status go to system status menu as follows System Status Item Current value Temperature 27 6 Internal pr
3. RBCHistogam Platelethistogram PLT Histogram 46 o 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 2 min ea Working environment 15 C 35 C relative humidity lt 80 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 Hermo3PC60 Auto Hematology Analyzer User s Manual 1 3 1 Front view Ave ciety Asal er Fig 1 1 Front view Indicator light yellow at startup turn red when starting sample test turn yellow after test Reset key reset instrument Aspiration key in sample analysis press this key the instrument will aspirate sample Sampling needle use sampling needle to aspirate sample into chamber Aspiration key in sample analysis press this key the instrument will aspirate sample function the same as key 1 3 2 Rear view M Fig 1 2 Rear view RS 232 serial port to connect with PC Power interface to connect with external power supply Power switch switch instrument power Diluent sensor interface Waste port Diluent port 00 0088 Hermo3PC60 Auto Hematology Analyzer User s Manual 2 Install
4. 4 3 2 X R QC run After QC parameter setting of selected QC file QC analysis of this QC file can begin In 27 Hermo3PC60 Auto Hematology Analyzer User s Manual main screen select QC file go to QC run screen as shown below X R QC Run QC 1 Lot Validity 2010 09 25 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 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 X R QC List QC 1 1 2 3 2007 10 26 2007 10 26 2008 05 24 2008 05 24 10 37 01 10 39 31 17 12 33 17 14 52 0 00 0 00 47 21 19 88 0 00 0 00 35 25 17 46 0 00 0 00 5 88 2 00 0 00 0 00 8 57 1 46 0 00 100 00 70 94 83 43 0 00 0 00 11 82 9 58 100 00 0 00 17 24 5 98 0 00 0 00 3 01 2 30 300 00 300 00 134 00 102 00 0 00 0 00 419 85 469 05 0 00 0 00 34 46 34 24 0 00 0 00 81 94 72 88 0 00 0 00 13 70 16 74 0 00 0 00 42 21 45 88 0 00 0 00 28 71 19 47 0 48 2 38 227 00 93 00 7 92 6 14 4 99 4 93 17 54 26 31 20 02 20 44 0 00 0 00 0 13 0 05 0 00 0 0
5. 7 2 5 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 or Setting Ws Name ETT Name Dept Applicant Inspector Verifier Fig 7 7 Doctor setting 40 Hermo3PC60 Auto Hematology Analyzer User s Manual 1 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 2 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 3 Delete select one row or several rows of data click Delete button confirm delete the selected doctor message will be deleted 4 Exit return to other setting frame 7 2 6 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 Communication Setting Port COMI v Baud rate 115200 v Bit 8 v Parity None M Stop bit 1 Y
6. 20 hazardous substance or element in product Toxic hazardous substance or element Component name Hexavalent Polybrominated Lead Mercury Cadmium Checa 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 5
7. 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 32 N A I WW Nm Nm o wo 9 Hermo3PC60 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 33 Hermo3PC60 Auto Hematology Analyzer User s Manual 6 History Data After test of each sample the system automatically saves test data Hemo3PC60 can save parameter test values and histograms of at most 100000 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 15 114 113 DEE 11 10 9 18 7 6 2009 03 10 2009 03 10 2009 03 10 2009 03 10 2009 03 10 2009 03 10 2009 03 10 2009 03 10 2009 03 10 2009 03 10 09 38 37 6 31 1 68 0 78 3 86 26 59 12 32 61 09
8. 00 100 00 100 00 100 00 100 0096 100 00 100 00 100 00 100 00 Setting amp T Delete amp D Save amp S Diluent amp I 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 Auto calibration settings Lot ZNDJFJI98 Validity 2009 E Y jos 4 M jor D Sample Type Whole blood C Peripheral blood C Pre diluted peripheral blood Targets WBC 9 70 x10 9 L RBC 4 21 x10 12 L HGB 122 00 g L RDW C 13 00 96 RDW SD 40 00 fL MCV 84 30 fL PLT 278 00 x10 9 L MPY 8 50 fL PDW 16 00 P LCR 30 00 96 Items iv WBC iv RBC iv HGB iv MCV RDW CV MPV PDW PLCR iv PLT Fig 5 3 Auto calibration setting 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 Validity 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 sample Calibration items items to calibrate Click Delete button current calibration sample setting data can be deleted Click OK to save current lot number data and exit
9. A c EL UI I I MTM 13 3 1 Preparation before startup eneen eenenen eenen ennenernensnrenerenenennen 13 32 iaa 13 349 Blood Sample coleccion iria 15 3 9 1 VENOUS blood cole cl sous ix Does ebat Fase acuit estes bred E aste det he breton bna beh 15 39 92 tellpreral blood GOllG CUOF oc piso PHI a pave pa usus 15 3 39 Blood Sample MIXING Sonate o uiam ndo ciiin delen 16 34 Blood Sample analysis srne rito ott ebat i n 16 4 5atmiple data lla 16 9 427 Blood Sadmple coutiltifig seti tomis dieto te motu Lotes ertum osse etin respi ua 17 3 4 3 Parameter prompt Message ccoccccccoccoccocococconoococonnononnononcononnnonnnnnnnnennnnnnnancaninnnns 18 3 4 4 Histogram prompt message ccccecceecceecceeceeeceeeseeeseeeseseueeeeeseeeeeseeeseeeaeeeaeeses 19 9 435 AQ USE MISTOOKAINN reticente 19 Hermo3PC60 Auto Hematology Analyzer User s Manual O iL ANIMI M i En ee CU 20 A Ouality Ola eedt 21 aeg E sien ee nn ne en sete A ae sen hon eae es ene eae eee TE 21 dele OC uet cR 21 7s ii EOC TON Tm 22 SEC NEP CT en 22 ATALS i T T TTE 23 P QI P TR T 24 42 AB OCS A 25 A ISU sene a Bee er nea eS ROE te SOE ee RRR ETON 7 ERE PER Sener Ne TEA 25 deo AB OC GAAN RTT T nm 26 E O OE 21 431 XR OC Setting ria 27 AS X rU ian dedu Mta MELLE ee ee ee SUL eee 27 MORS CIERRE LM EET 28 qd ot as Go PHARE eren etten endet Ide M LM LEE 29 OS AIM UO PNE TT 30 5 1 Preparation before calibratiON ooccoocconcccnconcociconionoconconoonnc
10. Applicant Inspecha VEL VEEN Tau TU AL BC Lar x x x X q mi pu iL E i x X sz Conen Cream Conen oma ome omen ome Fig 6 5 Sample history data This menu displays sample basic message test value and histogram click Previous item Next item 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 36 Hermo3PC60 Auto Hematology Analyzer User s Manual 7 System Setting System setting is used to set up system parameters 7 1 General setting In main screen click Settings and go to general setting window as follows Sys Setting Serial Number Language English Print instantly Print items Set Printer properties y joo A mla 4 Printer HP LaserJet 2000 7 ufo 3 mm 3 Printout ENTIRE PAGE WITHOUT HISTOGRAMS vl Hospital Special Startup Blank Test iv Pre diluted test mode inform Standby time mn Reagent Alarm Software C Hardware Clean Freq times Test Default Mode Whole blood C Pre diluted Fig 7 1 General Setting gt Serial number machine serial number used to identify one in
11. COE dd 46 m24 Drin PIDENE ETT m en eee ee eee ee 46 11 2 5 REMOVE BIOCK AGC nie e c don depo dis aea ettet itecto ta aus iade t secta ne 46 EZ OPINO ET id 47 Qu VET gem LT T 47 11 2 8 Concentrated cleanser SOakiNQ oocccocccoccccocncccnnconnnncnonononnnnnnnnonnnonnnnonnnonnnnnnnos 47 1129 CHECK mecha 4T TEZ IODE DUO epe e T T T TTE 48 IEA TENCIA A E N 48 142212 MACETA AA vr ende 48 112 13 OPUS ee Ee dend dee ee ee ee E 49 2 TA4Replce reagent Hc a uate 49 12 WOU ISSO OUI rennende neden ehehe etten 50 Appendixl Name and concentration of toxic and hazardous substance or element in product aaneen een eneen eneen 51 Hermo3PC60 Auto Hematology Analyzer User s Manual 1 Instrument Introduction 1 1 Product introduction 1 1 1 Product name Auto Hematology Analyzer 1 1 2 Model Hemo3PC60 1 1 3 Test items This analyzer is using impedance principle 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 76 Mean corpuscular hemoglobin MCH pg Mean corpuscular hemoglobin MCHC g L concentration Red cel distribution width CV RDWCV 34 Mean platelet volume MPV fl White blood cell histogram WBC Histogram Red blood cell histogram
12. Hematology Analyzer User s Manual If the hands or skins 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 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 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
13. 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 cleanser 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 instrument and PC 1 Take out RS 232 cable from packing carton 2 Insert one end of RS 232 cable into PC RS 232 interface socket 3 Insert anothe
14. SN SN helps us to provide service to users more conveniently and rapidly After click OK a prompt pops up to remind users of entering the values in parameter card inside packing case to corresponding interfaces This step shall be operated or guided by engineers Wrong entry may cause incorrect test result or abnormal operation of the instrument Note 1 After enter needle position value click Test to record the new value 2 After enter calibration coefficient click Save to record the new value 3 After enter potentiometer parameter click Update to record the new value It is needed to log in by the engineer can make entry in the corresponding interfaces LJ A After enter the software please enter the values in Parameter Table Fig 3 2 Input parameter values If the user has entered SN Fig 3 1 and Fig 3 2 dialog boxes will not pop up in the next time If computer fail to communicate with instrument the following screen is showed Hermo3PC60 Auto Hematology Analyzer User s Manual ct the machina Mechanics Reset Fig 3 3 Communication Error Main reasons for the communication failure 1 Hemo3PC60 auto hematology analyzer is off 2 Serial port line is connected incorrectly serial port cable or serial port is damaged Click Abort to stop execution of software Click Ignore and then press ALT F4 to directly enter to the system If the failure is eliminated click Retry to
15. Solenoid valve 2 to release positive pressure and negative 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 chamber draining 11 2 10 Debug Is for the engineer to test and debug the instrument 11 2 11 Egineering Just for the engineer to set up system parameters Warning engineers not trained by BGT Company are refrained from using this function otherwise test result accuracy will be affected or even normal test can not be performed 11 2 12 Machine reset When mechanical component is out of step you can restore original status with mechanical reset 48 Hermo3PC60 Auto Hematology Analyzer User s Manual 11 2 13 Stop use If the instrument will not be used for more than two weeks or to be packed for transportation 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 di
16. 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 contaminated test again in other method Warning only professional personnel verified by BGT can repair this instrument 50 Hermo3PC60 Auto Hematology Analyzer User s Manual Appendix Name and concentration of toxic and
17. maintain accurate analysis result discover and eliminate instrument measurement system error in time it is recommended to make regular quality control of instrument Hemo3PC60 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 Control No QC1 5 gt Brus Lot 224208N yatigity 2010 lt y 2 y i8 Ap C 0C3 C QC 4 c QC5 PIGET wec 8 40 1 00 x10 9 L McH 31 30 3 00 s QC 7 x10 9 L MCV 90 60 3 00 C QC8 C QCg x10 9 L RDW CV C QC 10 C QC 11 C QC 12 96 HCT 3 50 C QC 13 C QC 14 PLT 30 00 x1 0 9 L C QC 15 96 QC16 MPY fL RACE 0 30 x10 12 L s Item Targets Limits Item Targets Limits x10 9 L RDW SD C QC 18 5 00 giL C aci1g c 40 00 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 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 QC Rule i Once exceed 35D i Consecutive twice exceed 25D Consecutive 5 times at the same side of bias between 15D and 2SD Consecutive 7 times at
18. 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 Exit 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 Hermo3PC60 Auto Hematology Analyzer User s Manual L J QC List QC 1 Targets Limits 1 2 3 4 5 6 2008 12 28 2008 12 29 2009 01 02 2009 01 02 2009 01 03 2009 01 06 10 39 47 09 38 34 10 50 16 10 52 14 10 19 19 16 29 46 6 55 8 23 8 31 8 20 8 34 8 84 36 52 36 19 36 37 37 20 208 00 213 00 206 00 220 00 Fig 4 4 L J QC list The instrument will display 20 parameters QC result if some parameters are not controlled the corresponding column shall be blank Send function can transfer part or all of the L J QC data to external equipment Use mouse 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 g9 Selected Data 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 cha
19. of some parameters 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 PC to equipment to receive data start up and set up receiver software parameters For instrument transfer terminal parameter setting please refer to Chapter 7 System Setting Delete delete X B QC setting data 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 shown below 25 Hermo3PC60 Auto Hematology Analyzer User s Manual X B QC List Targets 1 2 3 4 5 16 2009 03 05 2009 03 05 2009 03 06 2009 03 06 2009 03 06 2009 03 06 10 54 49 10 56 03 08 44 48 08 46 03 09 14 41 09 39 12 7 70 4 71 4 45 4 04 5 47 9 75 1 27 1 21 0 54 0 48 0 81 1 41 1 11 0 44 0 41 0 42 0 54 1 20 5 31 3 05 3 50 3 14 4 12 7 14 15 54 25 78 12 27 12 15 14 94 14 58 14 38 9 36 9 23 10 33 9 78 12 22 58 98 64 86 78 51 77 53 75 28 73 20 4 07 3 69 4 34 3 87 4 32 4 89 135 00 124 00 142 00 127 00 135 00 151 00 363 31 353 85 359 87 364 23 352 77 379 34 33 10 33 58 32 59 32 92 31 25 32 84 91 12 94 91 90 55 90 37 88 58 86 57 13 68 12 82 13 82 13 87 14 34 14 90 42 65 41 61 42 82 42 88 43 45 44 13 37 06 34 99 39 33 35 00 38 25 42 34 180 00 197 00 226 00 214 00 296 00 279 00 9 29 8 18 8 42 8 75 8 54 8 29 10 08 12 38 11 82 11 10 11 54 12 14 0 17 0 16 0 19 0 19 0 25 0 23 35 61 25 10 28 24 29 94 29 06 26 29 Fig 4 8 X B QC l
20. 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 prolonged storage or inferior 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 profile Sample No 1 Name Sex Male E Age E Years 0 E Month 0 Days Sample Type Whole blood 7 Reference General Medical No Bed No Department Y Applicant Inspector M Verifier Last amp L Next amp N Savel amp 5 OK amp 0 Exit am
21. some sensitive parts For safety purpose users are not allowed to refit the instrument Hermo3PC60 Auto Hematology Analyzer User s Manual Contents HOW to USE this Man lisos iria rio 2 Main graphical representations used on this instrument 3 Warnings and security attentions occoccocccnccconconcnncnnoninnennonnncnons 4 1 Instrument NTOdUCUON cuernos 9 tal PAFOGIUCEIBIOCOQUIOHOR seren a 9 1 1 1 Product name Auto Hematology Analyzer sese 9 14 2 Model Hemos iue Siete ol eh tetas 9 DELENITI ER T 9 12 Prod ct technical parametel S annuleerde a ra M AA 9 1 3 Instrument composition and structure an oeneen eenen een ennveneeneen 9 O O I ME IE IR Te ea t SUEDE AMET 10 1 32 Rear M mQ 10 A oo o A 11 2 1 Instrument UNpacking ccocccooccoccccncoccccnconcoconononnoncnnanonnonconannononnnnnncnronannnos 11 2 2 Installation environment 5 2 voee eoe aed aet isa 11 29 FOWE Tedgulremelkib sicot ue M RE MN BENE S Ce tet bua ettet ode 11 ZAR AGC IN c T 12 24 Connection of LS and CEM o e En a d pe eru eee 12 24 2 Connection Ol GILG IG sadi mus e react ia 12 24 3 CODI c LIOD Ol WAS le esaet deeds iu esses dida 12 2 9 CONNECHON ormstrument and PO mmm 12 2 0 GONMEC to DIInltel sarecascsadennancidnansantdnataninienninaedessdaandnananatdounssandnasdninienninnededs 12 2 f SOolwatre IDstallallOlt o editi oai a teca tu RE ko ia 12
22. 0 0 00 0 00 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 28 Hermo3PC60 Auto Hematology Analyzer User s Manual 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 X R QC Graph QC 1 Validity 2008 09 25 Seq wae X Graph R Graph RBC X Graph R Graph Previous group u Next group D Move left L Move right R 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 distribution 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 X AR X X AR respectively Three values on the left of R chart are from top to bottom D R R k X IK X is mean value of
23. 1 0 5 P LCR 13 43 En Fig 3 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 38 Hermo3PC60 Auto Hematology Analyzer User s Manual 7 2 2 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 Population Category General C Adult male C Adult female C 14 18 years C 6 13 years C 3 5 years 2 months 2 years 8 days 1 months C First week C User defined Targets Limits Item Low High Item Low High WBC 2 15 x10 9 L RBC 2 5 7 x10 12 L LYM 0 4 6 x10 9 L HGB 90 180 g L MID 0 05 2 5 x10 9 L MCHC 280 450 giL GRA 1 10 x10 9 L MCH 20 40 pg LYM 10 60 MCV 70 110 fL MID 0 5 25 RDW CV 5 20 GRA 30 80 RDW SD 25 70 fL PLT 60 350 x1 0 9 L dadi ES be MPY 5 15 fL PDW 5 25 96 PCT 0 05 1 96 P LCR 10 55 96 EN Fig 4 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
24. 4 53 136 338 89 30 14 88 95 14 24 43 33 40 25 231 8 44 11 78 0 19 26 64 09 37 21 8 94 248 0 80 5 66 27 80 8 90 63 30 4 32 138 341 73 31 92 93 41 13 14 42 00 40 37 480 H T 79 13 43 0 37 21 14 09 36 08 4 86 1 65 0 42 2 79 33 95 8 59 5746 3 99 128 343 28 32 13 93 58 13 11 41 96 37 36 269 7 65 13 84 0 21 15 63 Total records 2470 Current records 7 Page 25 09 34 53 6 62 1 62 0 46 4 55 24 44 6 96 68 61 3 78L 119 337 53 3147 93 24 13 18 42 05 39 21 294 8 59 11 44 0 25 27 88 09 33 36 8 39 2 81 0 60 4 98 33 50 7 12 59 38 445 144 343 29 32 46 94 55 12 89 41 70 42 09 189 8 93 10 74 0 17 32 80 09 32 09 5 59 2 19 0 41 2 98 39 14 7 38 53 48 4 54 140 338 40 30 89 91 30 13 64 42 60 4141 306 H 8 12 12 54 0 25 23 37 09 30 50 EAT 295 0 70 4 52 32 81 9 01 58 18 5 37 164 341 28 30 63 89 76 14 03 43 07 49 18 234 8 69 11 24 0 20 29 75 09 29 37 6 91 1 55 0 37 4 98 22 56 5 36 72 09 H 4 68 143 333 54 30 43 91 24 13 65 42 62 42 75 351 H 8 27 12 17 0 29 28 09 09 28 23 3 87L 1 13 0 27 247 29 13 7 08 63 79 3 99 102L 31338 L 25 50 L 81 36 16 56 H 46 10 3243 177 9 66 9 51 L 0 17 40 00 09 27 10 7 66 1 71 0 59 5 36 22 36 7 65 69 99 3 68 L 85 L 310 57L 24 23 L 74 80 L 19 13 H 48 95 27 52L 333 H 9 61 got L 0 32 39 14 Fig 6 1 History record list Home screen of system displ
25. 7 2 3 Units To change parameter unit click Units button open Units setting menu as follows Unit Setting WBC LYM MIDE GRAX BN LYM MID GRA RBC HOU27 L HGB g L y MCHC HCT yl fL Pg MPY PCT PDW P LCR Fig 5 Units setting Totally units of 10 parameters can be set WBC LYM MID GRA use the same unit Select appropriate unit and click OK to save and exit click Cancel the Units will not be changed 39 Hermo3PC60 Auto Hematology Analyzer User s Manual 7 2 4 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 Department Setting Department Append amp A Modify amp M Delete amp D Fig 6 Department message setting 1l 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
26. Hemo3PC60 Auto Hematology Analyzer User s Manual ATTE BGT BioGenTechnologies BGT BioGenTechnologies GmbH Von Langen Weg 10 D 48565 Steinfurt Tel 02551 4090 Fax 02551 1298 Web www biogentechnologies de E Mail info biogentechnologies de Rev 1 0e Hermo3PC60 Auto Hematology Analyzer User s Manual How to use this manual Thank you very much for being the user of Hemo3PC60 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 Hemo3PC60 Auto Hematology Analyzer from BGT 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 sirictlly to make sure the normal performance of instrument and the accuracy of test result Declaration BGT reserves the Power of Interpretation to this user s manual The figures in the manual is only for demostration they may be diff
27. Profile180 Prine EHE Fig 3 5 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 or over 35 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 clog aperture or air bubble appears during counting and analysis Aperture clogged or Air 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 then check validity of test sample 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 va
28. am after running the Hemo3PC60 control software exit automatically instrument power can be switched off Warning never turn off power directly without running shutdown program 45 Hermo3PC60 Auto Hematology Analyzer User s Manual 11 Service Hemo3PC60 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 11 1 Routine maintenance 11 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 11 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 11 1 3 Clean instrument surface o Keep instrument working environment clean eo Instrument surface can be cleaned with
29. anonnonanons 30 52 Mental Calbra lO isso eiit eiie ei aeter aei tero aeita e Oo ite ooo tae idaeieo rotae ee 30 Do AOC ADTA O EE E t 0 0 000 00 mE TT 31 Ap DOA 34 System Sc MN 37 TA General SEG risas 37 l2 ROVANCEC Seti ene Cn 38 Ta Norma IEEE aten 38 Pe PANC MNS terende krenten A 39 Gece a p ks eee TR EU RR RIED HIDE EET 39 7 2 4 Department INfOrMatiON ooccocccocccoccccncccncncncononnnconnnnrnnnnnnnnnnrnnnnonononrncnnonanenannnss 40 Ls OC ION O ALON mms etend 40 L20 COMMUNICA ON se T UT 41 O USE IOS ses U Q 42 8 1 User Logon nennen nenne nennen nne snae nna snae nnns 42 OSC il En 42 9 System IniIromallOh outre uia san sad sede despair edendi veau ee ceca nidis 43 SSV tS US EEn 43 9 2 SY SCM OG retraite tanden A EEEE 43 9 9 otdustic In TOT TE OF see A A UM ND Tes 44 LOSA Weoo EUER E DD are 45 Hermo3PC60 Auto Hematology Analyzer User s Manual It SC Rue TERENTIUM UTEM 46 T T ROUTINE Tmialtenali6e cce Pr e ERE EOKO QUO E PEU PO UE PRU PO E PRODURRE RED RAE v 46 11 1 1 Startup and shutdown process occocccocccococonccoccoccnonoonnconnnncnonconononononnncnnonanonnnnons 46 MZ AO MAC NSO narren I REMIT 46 11 1 3 Clean instrument Surface eeina aea i ia 46 112 Maintenatice prog rain esnaera e E E vod ees 46 ZA BACK AUS Petre anastasi hen ende 46 11 2 2 Fig voltage PUISE nanne eeen 46 11 2 9 Dram CAMI sive eda debat cau et uu in SER equ LUE eben ru EON OPE Cu UTER AUS BK
30. ation 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 3 n accordance with packing list make sure the packing carton content includes e HemoPC 60 hematology analyzer e Users manual e Packing list 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 Hemo3PC60 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 35 relative humidity lt 80 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 and 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 Hermo3PC60 Auto Hematology Analyzer User s Manual 2 4
31. ays 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 Input data range 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 34 Hermo3PC60 Auto Hematology Analyzer User s Manual Click Cancel button the system will not select any record Send It provides data transfer function data selecting methods a use select function b Use mouse to click list column select one history data using keyboard Ctrl key 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 o Selected Data C All Data Send S Fig 6 3 Data transfer Select data to send click send Search Search function allows user to search required record according to designated condition click Sear
32. ch button open search dialog box as follows Inquiries Conditions Po Name PO EE Medical No gt Bed No Department Start Date Y Yx M viD End Date Y vM iD OK 0 Cancel C Fig 6 4 Search condition Sample no is the only identification of history record lf 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 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 columns can be selected If no data are selected the system will prompt to delete all sample data Print Print function prints selected history data according to system setting print mode See print setting in Chapter 7 System Setting Detail Detail function is used to check detail data message of a certain sample select one 35 Hermo3PC60 Auto Hematology Analyzer User s Manual record in history list click Detail button and go to Sample Detail Message Review menu as follows sample Ma 10 Type Whale blood H 2000 03 10 09 32 09 Position 2415 7471 Reference General Hame Sex Age Medical Ma Hed Ma
33. erent form the actual display please according to the actual display Unless been authorised by BGT No person or orgnization has the right to copy modify or translate this user s manual Only that all the following requirements are met BGT will be responsible for the safty reliability and performance of the product O Install adjust update and repaire are done by BGT authorised person 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 2 abnormal running of instrument the test results may be not reliable also it can break Hermo3PC60 Auto Hematology Analyzer User s Manual the parts of analyzer even endanger the health of operator Main graphical representations used on this instrument H jd dd IVD 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
34. essure 240 Fig 9 1 system status The system provides two test parameters now if test value is out of reference range related troubleshooting is necessary 9 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 Crue oen em Fig 9 2 System log 43 Hermo3PC60 Auto Hematology Analyzer User s Manual 9 3 Statistic information Statistic information includes instrument running time and samples tested in system message menu of main screen click Statistic it will go to statistic information menu as below Statistic information Running time since startup 1 Hours 41 Minutes Total running time 551 Hours 56 Minutes Tested samples today Total samples tested Fig 9 3 Statistic information Reset make all the statistic values zero Common uesr can not execute the reset function 44 Hermo3PC60 Auto Hematology Analyzer User s Manual 10 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 Shutdown button the system will pop up confirmation dialog box as below A A 22 Are you zure to shutdown E L ancel Fig 10 1 Shut down confirmation Click OK the system runs shutdown progr
35. group i R 2 RIK Ris M D R respectively where X i 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 Previous group Next group keys on keyboard or frame to switch between parameters Press Move left Move right 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 20 Hermo3PC60 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 BGT designated commercial calibration 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 w
36. hey 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 24 Hermo3PC60 Auto Hematology Analyzer User s Manual 4 2 1 X B QC setting X B QC Setting Basic settings Number Group 20 200 20 X B Analysis Parameters limitation Item Targets Limits Targets Limits 9 3 0 4 x10 9 L 29 2 10 32 1 32 64 3 6 x10 9 L 0 7 0 2 x10 9 L 13 5 4 7 0 8 x10 9 L 40 5 35 5 270 x10 9 L a 8 5 fl x10 12 L 16 giL PCT 0 2 g L P LCR 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 5976 1095 Save save QC setting data Items user can select QC of all parameters or select QC
37. ic classification result fails to meet requirement 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 Select histogram to adjust Fig 3 6 Histogram selection Select histogram to adjust click OK to return click Cancel then no histogram will be chosen 2 Use mouse to choose type line press lt to move left gt 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 Confirm button confirmation frame will pop up as below Fig 3 7 Adjust confirmation Click OK button to save adjust result click Cancel button to cancel this adjustment 19 Hermo3PC60 Auto Hematology Analyzer User s Manual 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 Hermo3PC60 Auto Hematology Analyzer User s Manual 4 Quality Control Quality control reflects system accuracy and repeatability Available instrument quality control program provides reliable and efficient way to check and prevent possible system error If there is system error sample analysis result will be unreliable To
38. ist 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 Previous page and Next page 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 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 X B QC Graph Current Total 1 1925 Time 2008 11 07 14 35 22 124 290 270 250 Previous group U Next group D Move left L Move right R 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 from top to bottom target value deviation target value target value deviation Press Previous group Next group keys on keyboard or frame to switch between 26 Hermo3PC60 Auto Hematology Analyzer User s Manual parameters Press Move left Move right keys on keyboard or frame to display QC data of various serial
39. ith calibration can be done by instrument automatically calibration coefficient is automatically saved Hemo3PC60 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 30 Hermo3PC60 Auto Hematology Analyzer User s Manual Sample Type Peripheral blood C Pre diluted peripheral blood Default Current coef Calib Date Default Current coef Calib Date 100 96 100 00 2008 12 26 100 96 100 00 E 100 100 00 9 2008 12 26 100 100 00 il og 2008 12 26 H 96 2008 9 25 2008 9 25 100 00 2008 12 26 100 100 00 100 00 2008 9 25 100 100 00 100 k 2008 9 25 100 i 00 00 E 2008 9 25 2008 9 25
40. kept vertically 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 Serial number In vitro diagnostic medical device Manufacturer Authorised representative in the european community Hermo3PC60 Auto Hematology Analyzer User s Manual Warnings and security attentions 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 BGT company 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 If abnormality happens the p
41. lick Last button to view last sample information Next to view next sample information and Save button to save current sample profile 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 four kind of blood type for selection which are whole blood anticoagulant peripheral blood pre diluted peripheral blood and control If select pre diluted peripheral blood mode first add 20yl 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 4 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 300yl 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 Testing after test parameter test result and histogram will be shown as follows Hermo3PC60 Auto Hematology Analyzer User s Manual Na 1 Name tex Age Department Applicant Inspector Verifier Heference Medical No Bed Mo xl yi OL TU unt 10 OL Modeten ReTeswen CT TET conte
42. lue H indicates that parameter 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 Hermo3PC60 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 basophils 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 automat
43. luent 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 Putinstrument and plastic bag packed components in instrument packing carton 11 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 49 Hermo3PC60 Auto Hematology Analyzer User s Manual 12 Troubleshooting 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 BGT 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 Solution 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
44. make the system run as normal way If the connection is normal the system starts to check the conditions of all parts and transfers the parameters required by the front end test the reagent blank as shown in the following Figure Mechanics Reset Fig 3 4 Startup program After startup self checking go to sample test screen as shown below 14 Hermo3PC60 Auto Hematology Analyzer User s Manual Na Name tex Age Department Applicant Inspector Verifier Heferenece Medical No Bed Mao BC Ly Mar i x 111 2 MIDI FAL zl OAN LYM ave E MD hea p GRAM mer RHC 0 03 10121 HGH u MCHC all MCH tans pa MCY en il ACY mer RDW SD il HET 0 16 se PLT 4 x10 9 L MEI iL Pow san a PCT aaa a ELER wiri x ModeitM Reressem l Profilef amp Pane Exija Fig 3 2 Blank test result Blank test only shows test results of WBC RBC HGB HCT and PLT The operator can run blank test at any time required Press Aspiration Key to start blank test During test the indicator light turns red status column on top of screen will display test status Blank test acceptable range is as follows If the results of blank test are not in this acceptable range please repeat the steps above until the results are good If the results are still out of range after 5 times tests please check if the reagent and connections of pipeline are good And plea
45. neutral detergent and wet cloth Warning do not use any solvent fat corrosive substance to clean instrument 11 2 Maintenance program 11 2 1 Back flush Back flush gem hole together with the function of High voltage pulse to prevent and eliminate clogging of aperture 11 2 2 High voltage pulse This function is to burn the gem hole to prevent and eliminate jam of hole 11 2 3 Drain chambers Drain off the diluent in WBC and RBC chamber 11 2 4 Drain pipeline Drain off liquid in the pipeline 11 2 5 Remove Blockage Particular procedure to eliminate the blockage of hole 46 Hermo3PC60 Auto Hematology Analyzer User s Manual 11 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 fill lyse into related pipeline 4 Cleanser fill cleanser into related pipeline 11 2 7 Cleaning When you think that the chamber has been polluted or the blank test result keeps unacceptable you shall use this function 11 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 gives the message to add c
46. 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 78666 Validity 2010 Y os 1 M 25 1 D Group num 3 Sample num per group 2 Fig 4 10 X R QC setting e Lot No lot number of QC object Expiry validity period of QC object Group No 2 60 default is 20 e Number of samples in each group 2 10 default is 5 Oo 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 eo Delete delete QC data of currently selected QC file e Send use instrument RS 232 serial port to transfer QC data of currently selected QC file to designated receiver Before sending please connect PC 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 e Exit return to main screen
47. oncentrated cleanser add it manually into the chamber You shall perform this operation twice every week at least 11 2 9 Check mechanics In Service menu click Check Mechanics key open mechanical test menu as below Mechanics Result Carriage Liquid Syinge Pressure Syringe Valves Exit amp X Fig 11 1 Mechanical test 5 66 5 17 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 BGT customer service department Click Valves button open solenoid valve test screen as shown below 47 Hermo3PC60 Auto Hematology Analyzer User s Manual Electromagnetic valve detection Valve 1 Valve 2 Valve 3 Valve 4 Valve 5 Valve 5 Valve 7 Valve 8 Valve 9 Valve 10 All Valves Fig 11 2 Solenoid valve test The instrument has 10 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
48. ower 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 Hermo3PC60 Auto
49. p C Fig 3 3 Sample data entry Sample No to modify sample no please input number within 8 digit length in sample no box 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 from 1 everyday Name maximal 20 letters Sex male or female may be selected if no chosen the system default is blank Hermo3PC60 Auto Hematology Analyzer User s Manual gt Age for Year Month and Day just input one number If multiple items are input then if 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 and day range is 1 90 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 14 18 years 6 13 years 3 5 years 2 months 2 years 8 days 1 months the 1 week and user define value can be selected The default is general Medical No patient medical record no Bed No number of sick bed of patient Department sender analyst and checker directly input or select from dropdown box please see detail setting in Chapter 7 system setting Click OK button system will update sample data and close the profile window click Cancel button return to sample test screen C
50. r end of RS 232 cable into instrument RS 232 interface Note to achieve optimum display of software interface the resolution of your display shall be set as 1024 x 768 2 6 Connect to printer This system supports most models of USB interface and parallel interface printers Please refer to User Guide of Printer to connect the printer to the PC host which connects with the instrument And then install the printer 2 7 Software installation The software can be installed under windows 2000 XP Vista system PC For specific installation guide see the attached CD Hermo3PC60 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 printer paper is sufficiently installed in right position 3 2 Startup 1 Switch on the instrument indicator light is on then Run Hemo3PC60 control software In case of first use or when SN is empty the system requires users to enter the SN which is on the rear label of instrument as shown following Figure Input serial number Please input serial number on the rear label of instrument Cea Fig 3 1 Input
51. rt 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 23 Hermo3PC60 Auto Hematology Analyzer User s Manual L J QC Graph QC 1 ZX24208N Validity 2009 02 17 Time 2008 12 28 10 39 47 Seq 8 49 0 29 3 43 4 08 0 07 1 81 127 06 2 63 2 07 221 34 20 51 5 heir Previous group U Next group D Move left L Move right R Fig 4 6 L J QC chart lt gt Lot No lot Number of QC sample corresponding to QC file lt gt Expiry validity period of QC sample lt gt Time test time of datum corresponding to QC point lt Segf sequence number of 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 5 11 Press Previous group Next group keys on keyboard or frame to switch between items Press Move left Move right keys on keyboard or frame QC data of different sequence Numbers can be 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 t
52. se try to use functions like Remove Blockage Back Flush Cleaning and Concentrated Cleanser Soaking in the software Service Menu to solve possible aperture blockage problem 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 method under atmospheric pressure anticoagulant must be dropped to all venous blood collection containers in advance usually EDTA K gt 2H20 is adopted as anticoagulant with content of 1 5 2 2mg ml 3 3 2 Peripheral blood collection e Blood sampling position Hermo3PC60 Auto Hematology Analyzer User s Manual 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
53. strument gt Time input or use adjust bar on the right to modify setting item set up new time only after saving gt Language used to switch between different system languages If one wishes to still use current setting after next startup please save language setting gt Print setting 1 Printer select internal Print the instruments 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 gt 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 37 Hermo3PC60 Auto Hematology Analyzer User s Manual sample number is above this value the instrument will run cleaning procedure one time If it is set zero it
54. the same side of bias Fig 4 2 L J QC criterion eo Items user may select all parameters for QC or select part of parameters for QC Send use instrument RS 232 serial port to transfer QC data of QC file currently 21 Hermo3PC60 Auto Hematology Analyzer User s Manual selected to designated receiver Prior to transfer please use RS 232 serial port cable to connect PC 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 Delete delete QC data of QC file currently selected 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 Lot ZX24208N Validity 2010 02 17 Targets Limits 8 40 1 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 4 10 0 30 130 00 5 00 346 00 40 00 3 00 3 00 0 00 0 00 3 50 30 00 0 00 0 00 0 00 0 00 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
55. 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 Standby time mn in this box input stand by time when idle time of instrument exceeds this value on the sample test window the instrument will stand by If it is set zero it will not stand by 5 Reagent Alarm reagent alarm mode by software or sensor 6 Test Default Mode set the default sample type after entering test window 7 2 Advanced setting In main screen click ADV SETINGS button open the menu as follows Doctor Info Exit X Fig 2 Advanced setting Default is common user then some settings are disabled to enable these settings please logon to be system administrator see detail in Chapter 8 User Identity 7 2 1 Normal limits After system administrator logon click Normal Limits button open setting menu as follows Population Category General C Adult male C Adult female C 14 18 years C B 13 years C 3 5 years C 2 months 2 years C 8 days 1 months C First week C User defined Targets Limits Item Low High Item Low High WBC 4 10 x10 9 L RBC 3 8 5 8 x10 12 L LYM 0 6 4 1 x10 9 L HGB 110 165 gil MID 0 1 1 8 x10 9 L MCHC 320 360 g L GRA 2 7 8 x10 9 L MCH 26 5 33 5 pg LYM 20 50 MCV 80 97 fL MID 1 15 RDW CV 10 15 GRA 40 70 RDW SD 35 56 fL PLT 100 300 sci raf id MPV 7 11 fL PDY 10 18 PCT 0
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