Hem-o-test 18RT - BGT BioGenTechnologies
Contents
1. 49 r a 1 ls 0 49 2 5 be Exchanoc or DUEN cos oc a ARI s one 50 BGT BioGenTechnologies Hem o test 18RT Chapter 8 Quality Control Calibration 50 Sl d he dPreparation ot Cali ads 5 5 2 Whole Blood Parameter Selo b bb Baban 51 ol Set ID s za a is I E ULM 52 SA Automate Cabra oet aet tla tta du dd e ullum E a ab au 52 5 5 uai AA A b S n sn 52 50 35 OU aby G OMT O DR JRR RR PR RR ERROR 53 S Restore Default Settings c EA ete eee p d 53 APPENDIX 1 Hem o test 18RT Series Packing List eene enne ener nnns 54 APPENDIX 2 Hem 0 test 15RTMEDMU o iet emos tas A 55 APPENDIX 3 Henro test ISRT Circuit Dia ram e io ea nina ds 56 APPENDIX 4 Hem o test ISRT Power Panel Schematic Diagram 57 APPENDIX Cop eli ina testata ote amen Ito A 58 APPENDIX 6 Brief Operation Instruction and NoticCe esses eene 59 BGT BioGenTechnologies Hem o test 18RT Chapter 1 Profile 1 1 Overview The user s manual including Hematology analyzer operation and general maintenance instructions in order to maintain optimum performance of the machine follow the manual instructions e Name and Scope Instrument name is Hem o test ISRT Automatic Hematology Analyzer It is used to detect blood of red blood cells white blood cells platelet count and HGB three categories The instrument2. 10x109 L If the background test result 1s out of range see 1t as malfunction 3 4 Sampling Risk of biological contamination samples reagents quality control materials standard materials and waste fluid have potentially biological infectious hazards Standard laboratory protective clothing should be worn wear gloves to comply with the provisions of the safe operation of laboratories Warning Don t touch the patient s sample directly operators in blood samples of patients to maintain adequate care operations in order to avoid infectious diseases To wear hand held surgical gloves when taking blood samples of patients e blood anticoagulant recommended K2EDTA anticoagulants the content defined as 1 5 2 2 mg mL blood K2EDTA is an ideal anticoagulant it can maintain the red blood cells and white blood cell count in the detection and classification of morphological stability e configuration of peripheral blood samples 1 choose PRE DILUENT mode 29 BGT BioGenTechnologies B measure S measure Hem o test 18RT Blood Pre dilute Figure3 4 Press MODE SELECT choose pre diluent in measurement set Return to measurement interface after set See picture 3 5 Derim arda 10 00 1069 1 TEC LTF TitE Crank LTE Tid Crank HCH ror 2 Add diluent 8 in O0000039 00 00 o 00 mali 4 00 0
3. 3T r L 110 16 0 PLT 34 0 54 0 IL iw 300 109 L T 4 ILE L 00 0 10 0 26 L L 10 0 zzm 8 B 5 10 15 20 25 30 Histogram Display area Result display area IL 17 45 50 eoppeopposopseopeppepp Figure 1 10host interface of measurement Toolbar this area set up six control button Setup area of sample information ID number number bar code number and service position No measure button push this key on the touch panel machine would ask for inputting the service position No after inputting the service position No machine would scan bar code on the sampling plate after scanning the machine start to measure edit button push this key on the touch panel would enter into the edit interface of case information like figure 1 11 Name ID Branch Sex Serial Code Checker Age Sequence Sender Date Type Figure 1 11 edit interface of case information Case history Can edit the case history information in this interface can input by keyboard also can input by handwriting After measuring this information is been stored into the database can consult recorded data in the sample 20 BGT BioGenTechnologies Hem o test 18RT management please refer to S6 1 sample review print button push the print button can start to print Mode selection press this key to enter into test mode as per figure 1 12 this interface can p
4. 7 21 2 43 0 76 7 75 2 53 1 11 4 11 7 75 2 40 0 60 A 74 0100000819 0 00 0 00 0 00 0 00 000000820 7 74 2 49 0 63 4 4 000000821 8 13 2 51 0 76 4 66 000000822 8 84 2 62 0 61 5 41 Figure6 2 Drop down box of Query Way Select the query way such as ID No 2 Enter Query Way At the upper left of the Sample management interface Query Way can be founded and there 1s a related box touch the box and enter relevant query in line with the query way selected on the left query way accordingly such as ID No 3 Touch and press Search in the upper middle position of the interface and the patient result queried will be displayed like the Image 6 2 3 1 Display All When the user wants to review all of the patient results in the data library touch and press Display All in the upper middle position of the interface all of the patients results will be displayed And all the data can not be displayed in one screen when too much data has been stored and the scroll bar is to produce automatically Press the scroll bar on the right size of the chart and touch and press the scroll bar up and down to check all the data 3 2 Print the data Enter Sample Management from the main interface there is no Print the selected data displayed in the upper right or Detail Only on the interface that the data list the user can touch and select an result and Print the selected data and Detail both are displayed
5. BGT is not responsible for the damages made by customers incorrect operation Contact Us BGT BioGenTechnologies GmbH Von Langen Weg 10 D 48565 Steinfurt Tel 02551 409 Fax 02551 1298 Web www biogentechnologies de E mail info biogentechnologies de 58 BGT BioGenTechnologies Hem o test 18RT APPENDIX 6 Brief Operation Instruction and Notice Operation Instruction 1 Prepare before start up Check whether the reagents are enough or not and check whether the reagents 1s good or not Make sure the reagent pipeline is ok and empty the waste liquid bottle 2 Start Up ress the power switch in the back of instrument to the position of 1 then the machine automatic starts up and begins power on self test If everything is OK the screen will display the count interface 3 Background Count Press the start button the instrument begins to count the result is as below WBC lt 0 2 RBC lt 0 02 HGB lt 1 PLT lt 10 4 Whole Blood Test Press the Menu button choose the Mode button and set the mode to Whole Blood Use EDTA2K as ticoagulant to make blood specimen the quantity of EDTA2K 1 5 2 2mg ml blood Make the specimen well distributed and then press the Start button to test 5 Peripheral Blood Test Press the Menu button and choose the model then set the model to Prepare Dilute Press the 0 Dilute button and then press the start button It makes the automatic sampling n
6. tg E hy 4 B 5 5 H 5 4 M ne 2 12 Ba La A XU Figure 1 7 circuit clapboard sketch map Hem o test 18RT 1 Washing solution interface 2 Dilution solution interface 3 Hemolysin interface 4 Waste liquid interface 5 Power interface 6 Earth terminal 7 Power switch 8 Parallel interface 9 Serial interface 10 USB interface 11 Network interface 12 PS2 interface 13 Printer interface 1 Analog mu circuit 2 Built in micro printer 3 Governor circuit 4 Pump valve driven circuit 17 BGT BioGenTechnologies Hem o test 18RT Emergency DEST BioGenTechnologies Figure 1 8 Mask button e Touch screen Among Hem o test ISRT auto hematology analyzer Hem o test 18RT is touch screen Hem o test 18RT is not touch screen non touch screen model use mouse and keyboard to operate According to the content which appear on the screen touch the related place to finish the related function After open the system and self checking which appear the main menu like figure 1 9 18 BGT BioGenTechnologies Hem o test 18RT CIEN G SA Measure Service Sample Manage BGT BioGenTechnologies System Maintenance Figure 1 9 main menu Above have seven submenu measure set up maintain service s
7. 1s mainly used for quantitative measurement of blood parameters of 19 and 3 Histogram 1 WBC 2 Ly 3 Mid 4 GRan 5 Ly 6 Mid 7 GRan 8 RBC 9 HGB 10 HCT 11 MCV 12 MCH 13 MCHC 14 RDW cv 15 RDW sd 16 PLT 17 MPV 18 PCT 19 PDW 20 WBC Histogram 21 RBC Histogram 22 PLT Histogram e Product Classification Instrument classification standard description BGT BioGenTechnologies Hem o test 18RT According to Chinese Medical Equipment Management Classification Belonging to the blood analysis system of Clinical Laboratory analytical instruments 6840 the management category for class II Classification by electric shock Class llover voltage transients rated pollution degree 2 Classification by character of service Continuous operation equipment e Reagents quality content and standard content Reagents quality content and equipment constitute a system must be used as a whole to ensure that all products have received the test of manufacturer Recommend the company s assorted reagents referring to special reagents exclusively for the Hematology Analyzer these reagents have been tested with this instrument and all qualified do not use different quality content or reagents provided by other suppliers otherwise will not achieve its performance targets without the test reagents may provide unreliable data Each reagent before use must be checked container damage may affect the quality of reagents If the box 1s damaged check
8. 3 8 34 BGT BioGenTechnologies Hem o test 18RT Outer config Print English Don t print I f 4 amp Picture 3 9 As to printing form there are four kinds to choose Chinese parameters with histogram Chinese parameters without histogram English parameters with histogram English parameters without histogram If it needs to connect external printer first confirm that the connection is all right and then turn the printer on The device can recognize the external printer automatically After blood analysis 1s finished the external printer will print the results automatically Operation of Counting Counting operation Placed the the anticoagulant venous blood under sampling needle Press Start button counting began when hear the beep is heard the sampling needle lift remove exploitation of blood vessels equipment start processing samples Counting process of prompt zone Show Count Process Count of about 1 minute to complete instruments issued by a beep sound the sampling needle back to the initial bits counting results showed that screen ID number plus one automatically then continuously test next sample Pre dilution counting operation According to the previous pre diluted sample solution prepared a good pre diluted sample solution on the sampling needle press Start button counting started When the sampling needle lift the removal of blood began to measure the working pro
9. Add 1 1ml Dilution into WBC pool to form 1 263 sample The 1 263 diluted sample into two parts Take 15 2uL 1 263 diluted sample and 3 9mL of the diluted solution mixed to form 1 45000 sample and to measure and count red blood cell and platelet The rest of 1 263 sample and 0 5mLHemolytic mixed then plus 0 5mLDilution to form 1 378 sample and to measure and count Leukocyte After the second dilution and before count Hemolytic agent will be added into WBC to dissolve the red cell membrane samples usually erythrocytes 1000 times more than leukocytes 1000 time before measure white blood cell red blood cell must be eliminated its interferencered firstly Red blood cells are usually without nuclei Hemolytic agents can play elimination of white blood cells diluted the role of red blood cells Relative to the dilution the cell impedance is much greater and this is the mechanism of the counting process when cells by counting the holes it will generate higher than the original instantaneous dilution resulting impedance The size of the impedance change is proportional to the volume of the cell the instrument will change the impedance caused by the amplification of pulses and recorded As image 1 2 e Cell Size Cells by counting the holes the resulting electrical pulse amplitude and its volume are proportional to the size of the larger cells to produce electrical impulses by a big margin Cells by hemolytic agents and the role of dil
10. BGT BioGenTechnologies GmbH BGT for short possess the copyright of this non public publish guidebook The guidebook is only used as common reference of operating maintaining and repairing BGT s Hem o test SRT Nobody ss allowed to public the contents of this guidebook Some contents of this guidebook are proprietary protected by copyright law Without permission of BGT any part of this guidebook can not be copied reprinted and translated to other languages BGT does not have any obligation of the guidebook And we are also not responsible for the errors of information in the guidebook and the damage carried up by the guidebook s supply The contents of the guidebook can be changed without any notice Obligation of Manufacturer BGT will be responsible for the safe reliability and performance of the machine only under the condition Installation edition upgrading system expansion improvement and repair are all done by the ones confirmed by BGT Please use the reagents designated by the manufacturer We will not be responsible for the damage made by the use of the non designated reagents Warning Hospitals and other institutions which use this instrument have to make maintenance schedule BGT will provide circuit diagram used in repair and the method of how to calibrate this instrument when the customers need it It can help customers to repair some parts of this machine which can be repaired by themselves under the permission of BGT
11. Measurement for Emergency Diagnostics In batch measurement if the case is emergent press button Emergency diagnostics the dialog for emergency diagnostics will appear in Picture 3 7B SS popopoopopoononopmpmms 17 45 50 batch blood scan c wait ec 10 Figure3 7B Selection Picture of Emergency Diagnostics Position 32 BGT BioGenTechnologies Hem o test 18RT Select emergency diagnostics position press OK button and enter emergency mode And the station column shows as emergency position 10 See the following picture 3 7C Sequence DDD lerdo ueber LT hem Meri di Pekan Asa TEC LT 00 Grand LTE a Ri d a Crank BCH FEL 00 ACT ECT ECH a ECAC EKDF cw 6 06 EDF sd 6 06 FLT REY PCT 00 5 e 4 00 10 00 0 820 4 00 0 10 1 50 2 00 T 0 20 0 40 0 2 0 10 06 50 0 70 0 110 170 3 50 6 00 0 37 0 51 El 100 26 0 36 310 370 11 0 16 0 34 0 54 0 oo 300 T 4 12 5 0 10 0 26 10 0 722 0 batch blond scan c ieri 109 L 103 L 1091 10 1 X x g L 1a Z L L IL Pg fil fL 109 L fL L L ad di i t 1 in 00000039 wait ec 10 mer wait ec 10 17 45 50 Figure 3 7C Emergency position measurement Emergency position measurement begins after the present measurement finished
12. The following measurement continues after emergency measurement single Measurement for Whole Blood Press button mode setting and enter the interface as following Set it as single mode and return to measurement interface Open the sample device and take out sample disk First shake the blood samples manually to an average state and then put them into sample devices one by one Be careful that the bar code of blood sample should face the groove of sample disk so it s convenient to scan Shake blood samples to an average state by sample disk so it s helpful to the accuracy of the measurement results Put sample disks to sample devices and close the cover Press button measure the following picture 3 7D will appear 33 BGT BioGenTechnologies Hem o test 18RT kas batch brood ready Picture 3 7 Position Selection Select position which is ready for measurement in dialog 1 18 and press OK The dialog will close and it begins to scan bar code measure and clean After the measurement is finished it will show all the measurement results and histograms The record will be kept in database The records can be looked up in samples management Pre dilute mode is the same as whole blood mode Set printing methods Press set in main menu and enter the following interface as 3 8 Select printing settings as picture 3 8 Picture
13. diluted blood samples the red blood cells will be dissolved and release hemoglobin Hemoglobin combined with hemolytic agent can form complex the monochromatic light with wavelength 540nm measured the intensity of this compound in WBC count pool we can get the hemoglobin concentration of the samples blank refers to the stats of WBC count pool when there is only dluent after compared the through intensity with the empty state of the through intensity The equipment will complete the two testing process automatically and then calculate and show the print results in unint of G 1 Light transmission intensity of the blank AGB Conan x ees The sample transmittance intensity of e Red blood cell RBC unit e Structure Front electrode Javel hol Bach ele ebode wolaton hole Image 1 4 RBC structure BGT BioGenTechnologies Hem o test 18RT eRed blood cell RBC amount Obtained by direct measurement of pulse number RBC nx10 L eMean volume of red blood cells MCV The equipment will count the electrical pulse that generated when every cells passed the RBC probe and then classified and summaried by the size volume size finally they will be corrected by the microprocessor to calculate the average volume MCV of all RBC Hematocrit HCT Mean corpuscular hemoglobin concentration MCH and Mean corpuscular hemoglobin concentration MCHC Calculate the HCT MCH MCHC by the following formula RBC x M
14. for if have leaks or moisture within the interior If yes do not use the reagents The use of chemical reagents needed to understand the use of precautions Reagents should be used and stored at room temperature Attention In order to properly and safely use the kit please refer to the label on the box and valid data sheet Dilution Dilutions in dilute the blood samples at the same time provide the similar environment with plasma for blood cells to ensure a certain period of time to maintain the volume of blood cells do not change and provide a conductive environment for the blood cell count Hemolytic Reagent Hemolytic reagent can rapidly destroy the red cell membrane and let cell debris to reduce the volume to not interfere with the analysis of white blood cells Thus white cell can be classified by three groups Hemolysis agent can and hemoglobin to form stable compounds this complex absorbency and hemoglobin BGT BioGenTechnologies Hem o test 18RT concentrations are concerned For the correct White blood cells three classification PL 6A hemoglobin and White blood cells analysis hemolysis reagent must with PL 6A series dilutions supporting the use probe solution It is an enzyme based cleaning solution and wetting agents For the sampling needle piping and count pool cleaning the probe solution is a specific reagents the solution will not damage the road part of the analyzer cleaning fluid
15. lower than the location of this instrument Put the other end of the waster catheters into waste barrels Connection of the distilled water Take out the distilled water rubber hose component e from the annex bag Let one side of the catheter connect with the distilled water bottle and the other side clockwise screws with connectors from up to down the first one or the blue one of distilled water on the back of the instrument Wastewater treatment Risk of biological contamination samples reagents quality control materials standard materials and waste liquor etc have potentially Bio communicable dangerous Should wear standard laboratory protective clothing wear gloves to comply with the provisions of the safe operation of laboratorv Warning User obligation to abide by local national waster water discharge of the relevant provision Recorder Paper Installation Click the recorder button on the recorder top right open the recorder door The rolls of paper being put into the paper feed port print face up face the thermal head paper head above the door edge close the recorder door Press the green light button green out press the red light button goes a paper Paper to go the end the normal recording paper installed Press the green light button the green light comes on recorder in working condition B Printer If the system 1s equipped with printer use the printer cable connect the printer with the ins
16. of the reference value Choose the classification then click the item of which to change the superior and inferior limit you will see a keyboard enter the value you want to change to then click enter Others are the same as this method 7 3 Packaging Service This is used by the manufacturer or the maintainer to avoid losing of the data users please do not operate it 7 4 The Exchange of Hemolysin Press exchange hemolysin bottom then you will see the progress bar when the exchange is completed the progress bar will close itself 7 5 Add Pre diluents Liquor Put the soft test tube in the NO 1 work station press add pre diluents liquor then you will see the progress bar the sampling probe will add quantitive diluents liquor after that the progress bar will close itself 7 6 Detecting Head Soak Put the soft test tube in the NO 1 work station which is full of detecting head soak liquor but not too much liquor Then press detecting head soak bottom the equipment will do it automatically and after that the progress bar will close itself 7 7 Strong Enzyme Liquor Soak Soak solution need apply the strong enzyme liquor operation method is the same as the detecting head soak 49 BGT BioGenTechnologies Hem o test 18RT 7 8 The Exchange of Diluents Clean the tube and the air bubble in it Press exchange diluents bottom the equipment will exchange the diluents automatically after that the progres
17. solution PL 6A dilution solution Hemolytic agent PL 6A Haemoglobin and White cell analyzer Hemolytic agent 15 BGT BioGenTechnologies Hem o test 18RT HB strong enzyme washing solution HB Probe washing solution Power Supply Voltage AC 110V 240V 47 Hz 63 Hz Power Supply 150VA Fuse AC 250V F2AL Work environment Environment temperature range 10 C 35 C Relative humidity range lt 85 Atmospheric pressure range 70 0 106 0kpa Power supply AC 110V 240V 47Hz 63Hz Environment limitation condition for transportation and storage Storage temperature range 10 C 40 C Storage humidity range lt 93 Atmospheric pressure range 50 0Kpa 106 0Kpa Appearance size 40cm L 39cm W 46cm H Weight 25KG e Optional configuration There are some optional accessories for you to choose and if you choose it the additional charge will be paid by your side pls see the below table Service manual l bok one 1 3 Jows 0 r ik mimi 1 4 Structure and operation The machine is made up of sample dilution and assign unit sample test unit low noise magnify circuit photoelectricity test system touch screen and keyboard control system microprocessor control system LCD display sample result output system and power supply system Kindly pls see below detail e Mainframe 16 1 Touch Displav BGT BioGenTechnologies Figure 1 5 The front appearance B 3
18. 20 0 10 2 00 20 0 2 0 50 0 ii 3 50 37 El 26 0 310 11 0 34 0 106 T 4 l 4 00 1 50 1 ED 40 10 0 T0 1760 6 00 0 51 100 35 0 3710 16 0 54 0 S00 12 5 0 25 Ika 270 batch Pre di 163 L 10971 1091 x x TIEN L L IL PE giL fL 109 L fL L L Figure3 5 Take a clean test tube on the injector press with liquid key to enter with liquid interface as shown in Figure 3 6 each instrument adding 1 6mL diluent 30 BGT BioGenTechnologies Hem o test 18RT Mix Dilute Liquid Figure3 6 Select the liquid position in this interface push the start with liquid instruments automatically fun the function of pre dilution 3 configuration sample Use the 20uL blood sampler to collect sample be careful not to squeeze hard tissue fluid mixed with blood samples from fingertips to create the results inaccurate use clean paper towels lint attached to the outer wall of the blood in the tube 3 Inject the sample immediately into sampling cup filled with 1 6mL dilution fully mix the sample test the samples after placed about 2 minutes Caution Ddiluted sample after place for too long can not guarantee the accuracy of counting Avoid any contamination into the diluent 3 5 sample counting whole blood batch measurement operation Do the following operation under WHOLE BLOOD mode 3l BG
19. CV HCT 96 10 HGB g L MCH pg RBCUL HGB g L MCHC FOTO x100 e Red blood cell distribution width coefficient of variation RDW It is obtained from the RBC histogram The percentage can express volume distribution coefficient of variation ePlatelet PLT amount It is obtained by direct measurement of pulse number PLT nx10 L Mean platelet volume MPV It is obtained by PLT histogram calculation unit fL e Platelet distribution width PDW It is obtained by PLT histogram Geometric standard deviation for platelet volume distribution 10 GSD e Monitoring block hole Human blood contains proteins and other particles The proteins and particles will stick on the count holes and pipes during the sample counting process and this will affect the result of measurement after a long time accumulation Holes blocking can be avoided by high voltage ignition after each sample collection and the daily and 12 BGT BioGenTechnologies Hem o test 18RT weekly maintenance On the other hand the equipment has the function of block hole monitoring When the counting time 1s out of range the equipment will emit an alarm to warn the users of the hole blocking problem 1 3 Performance introduction Equipment structural classification Model Structure and Function 8 inch 800 x 600 TFT color LCD screen panel type thermal printer built in puncture sampling and dilution devices intelligent bar code
20. HB enzyme concentration cleaning fluid HB containing enzyme cleaning solution is a kind of isotonix cleaning fluid based on enzymatic cleaner and wetting agents Used for cleaning tube and count pool This cleaning solution is a kind of special reagents not damage the analyzer of liquid road section For machine maintenance Quality Control Substance Quality control substance used to calibrate and quality inspection Quality control substance is a commercial production of whole blood products for the testing equipment functioning properly or not Quality control substance is with a low medium and high value of three Every day three quality control substances can be used to check the machine running condition ensuring the veracity and reliability of measurement results A Note of Caution Hem o test ISRT Automatic Hematology Analyzer only for in vitro analysis of human blood no other specific uses Only allow the use of special reagents mentioned in this manual or they will not guarantee the reliability of measurement data Please read this manual carefully before operating equipment and save it for later use If the equipment has the odor or smoke immediately cut off the power and contact with the company s after sales engineer continue to use the equipment may cause fire electric shock or injury f the liquid inflow into the instrument or equipment leak cut off the power immediately and contact the company after s
21. Operator Manual Auto Hematology Analyzer Hem o test 18RT BGT BioGenTechnologies BioGenTechnologies GmbH Von Langen Weg 10 D 48565 Steinfurt Tel 02551 4090 Fax 02551 1298 www biogentechnologies de e mail info biogentechnologies de BGT BioGenTechnologies Hem o test 18RT Contents Chaple brote adan 4 MAI dete ter E 4 I 2 D tectton Primi ple ad 7 DOr eh ROPING Modu m 13 idc SIUC Wire dnd Opera lon DU 16 Chapter 2 Instalamos 22 POLICIER ROREM 22 2711570077 li ikili 22 2 Machine stollar a EI 23 Chapter gt Blood Analysis 2254595005060 b b 26 ARO a a a as 26 2 BOGLETOS S s b solo o so n a 27 3 3 Count DME ICE nocni E RR AA a 27 E r Ds IR a a a 29 A sk ibn 31 S0EPOYCPORcu o RB 36 Chapter D B o 38 r o Pe 39 Se LP rant te IT 39 o RR au bau Sud 40 5 0506 o 00 40 AY e E E b o b o eb co o o 41 a a isa 42 SEN REE he 6 O NUES A ANA 42 PTU Tn o s Mae dn Ree oa in 43 Chapter 6 Sample 43 ol MnP VS VIS W a edd icc E E E EO OR RR 44 ioris a m m B s 47 IO WAN Ce ann baba l 47 T Edition Of RE 48 12 AC KAP cc YY bb bb 49 LATAS EXC Hane orman 49 7 Add Presdiluents TAQUILLA a ala ie 49 TO Dereng Head SOR dedere a au
22. T BioGenTechnologies Hem o test 18RT 3 21 44 4 44 0600035 Sequence OO Torik torte Werle ueber hem Karun edo Retro Meriter FEC 00 4 00 J 10 00 0 LTF 00 60 20 4 00 1o3 L nur 00 60 10 1 50 ipfi Crank 00 2 00 T 20 109 11 2 0 100 x Crank 5060 T x 1106 1T z L 00 3 50 amp 00 10l7 L DO 0 37 over L L B0 Too fL 26 0 35 0 Fe 310 370 giL 110 ih x PLI DO 534 0 54 0 IL 5 1021 TN IZLE fL DO 0 10 26 L L 100 722 0 1 5 E 40 15 20 25 30 5 oppoppononmnponopopmmmnm PER IL batch blood ready 17 45 50 Figure3 7A Press the button Mode setting and enter the interface like Picture Set it as Batch Mode and return to measurement interface Open the sample device and take out sample disk First shake the blood samples manually to an average state and then put them into sample devices one by one Be careful that the bar code of blood sample should face the groove of sample disk so it s convenient to scan Shake blood samples to an average state by sample disk so it s helpful to the accuracy of the measurement results Put sample disks to sample devices and close the cover Press button Measure it begins to scan bar code measure and clean After the measurement it will show all the results and histograms These data is recorded in the database In sample management measurement record can be looked up
23. a can be considered as available only after the equipment has been calibrated The using of sample and reagent is the QA quality assurance of the calibration Users should adopt the ones we recommend Store the samples correctly use the reagent within the validity before the calibration restore the sample to room temperature and blend the sample until it is well distributed The frequency of the calibration after maintenance or deviation appears during calibration in which condition calibration 1s required 53 BGT BioGenTechnologies Hem o test 18RT APPENDIX 1 Hem o test 18RT Series Packing List Hem o test ISRT PACKING LIST NO ACCESSORY NAME SPECIFICATION QTY PRODUCTS MANUAL CERTIFICATE OF APPROVAL POWER WIRE TYPING PAPER 57x35mm z gt OUSE OP 220 USE UN AMPLE CUP un es PCS PCS PCS PCS PCS PCS PCS ANTI FREEZING PIPE 2mL PCS PCS SOFT TEST TUBE SILICONE TUBE 12mmX 80mm PL 6A DILUENT Un PACKAGE PL 6AHEMOGLOBIN amp WBC HEMOLYTIC 500mL AGENT PACKAGE HB DENSE ENZYME WASHING LIQUID BEN PACKAGE HB PROBE WASHING LIQUID A PACKAGE BGT BioGenTechnologies GmbH HOTLINE 02551 4090 PHONE FOR REAGENT 02551 4090 SERVICE LINE 02551 4090 UNIT REMARKS CONTAINED IN REAGENS CONTAINED BOTTLE IN REAGENS CONTAINED BARREL IN REAGENS CONTAINED BOTTLE IN REAGENS 54 BGT BioGenTechnologies He
24. al waste have potentially infectious hazards Standard laboratory protective clothing should be worn wear gloves as to comply with the safe operation rules of laboratories Warning There are potential biological infectious on the sharp sampling needle it is necessary to avoid to contact with sampling 23 BGT BioGenTechnologies Hem o test 18RT eConnect with liquid pipeline Dilution s connection Remove the dilution rubber tube from attached bag Take out the barrel which filled with dilution put one end of liquid guide tube into dilution barrel as per figure 2 3 and then screw the barrel lid clockwise Connect another end of liquid guide tube with dilution connector white color then screw it tightly clockwise Figure 2 3 Dilution s connection e Hemolytic Agent Connection Take out the hemolysin hose component from the annex bag Let one end of the guide liquid tube connect with hemolytic agent bottle and he other end connect the back of the instrument hemolytic agent liquid road connector yellow clockwise tighten Figure 2 4 Hemolytic Agent Connection e Waste liquid catheters connection Take out the waste liquid catheters from the annex bag Let the red fluid catheters road junction connect with the back of the instrument waste liquid liquid road connector red clockwise tighten 24 BGT BioGenTechnologies Hem o test 18RT Waste barrels with the instrument placed on the same level as high as or
25. ale technical service department contact see annex I 1 2 Detection Principle Cell counting principles The blood sample is measured by the instrument need to be diluted by the specified dilution ratio to measure WBC RBC PLT and HGB and other parameters The dilution samples of WBC RBC counting chamber under negative pressure separately through their respective counting pore the amount of fluid flowing through the fenestral is the sample volume of the instrument for analysis This machine uses impedance measurement to test quantity and size of WBC RBC and PLT Electrodes insert in the liquid on both sides of the counting hole and build a field environment under the blood cells of non conductive nature when a cell by counting the pores it will lead to changes in impedance changes in the size of the impedance and cell volume is proportional As Image 1 1 BGT BioGenTechnologies Hem o test 18RT electrode of the front vacuum x electrode of the front sample of blood Counting pool Ger Hole Electrical pulse ef BALA Lh Number Time Image 1 1 5 chemate of pinhole resistance measure ment Image 1 2 A small electrical pulse produced by Blood cells Instrument calculates each cell and classifies them according to size In this way the instrument measured the number of cells more than the manual method of measuring the number of cells under a microscope and to overcome the manual count of the impact of h
26. ales engineers continue to use the equipment may cause fire electric shock or injury Do not block vents of after the case as they are for ventilation to ensure reliable operation of the instrument For your safety and reliable operation of equipment the machine used must have a good grounding power lines Please abide by all the health and safety standards including but not limited to the operation and maintenance of the equipment should be equipped with protective goggles gloves and appropriate experimental equipment e Safety Symbols Full text of this book will prompt these symbols where necessary to warn of potential dangers BGT BioGenTechnologies Hem o test 18RT Ignore this signal or misoperation equipment will biological risk Indicates the presence of biological risk alar cause operators to death serious injury Ignore this signal or misoperation equipment will gt notice cause operators to death serious injury Expressed the hope that the information you need know to keep instrument performance e Additional information The company will occasionally send operation maintenance additional information of the machine please read the manual and add it to inspection e Maintenance Services If the equipment does not work please refer to the manual instructions in Chapter VII If according to the instruction of Chapter VIII still can t trouble removal please contact with the company after s
27. ample quality control shut down measure built a window of sample data setup to manage the information of patient and doctor select of take blood mode print the test result etc set up built print setup plus setup password management factory setup time setup date setup system setup to set up the system Maintain can finish the work of wash pipeline detect electric motor service buit nine options to finish the hole voltage test A D waveform testing reference value edit packaged service add prediluent dip probe solution dip dense enzyme solution change diluent change hemolysin Sample built list review histogram review to inquire sample data Quality control built seven options to correct the various parameters Shut down to shut down the machine eButton panel Three panel button finish the rapid operation of hematology analyzer Emergency button is to enter the emergency mode start button is to test rapidly Power button 15 to open shut down the machine rapidly escreen display 19 sample information BGT BioGenTechnologies Hem o test 18RT EA in 000000 4 Suena hh oral coda i Vers azalar a TEC 00 4 00 10 00 10 LT foo 6 20 4 00 109 Bidt 00 0 10 1 50 1091 Grand oo 2 00 7780 10 LTE 20 0 40 0 x Bid 2 0 iho x Crank 50 0 T x HCH i10 1TO DO 3 50 poy 105 0 37 051 L L 20 100 IL 2858 0 S35 0 Fg 310
28. an the pipeline 36 BGT BioGenTechnologies Hem o test 18RT automatically Processing waste Risk of biological contamination samples reagents quality control substance the standard materials and liquid waste and other potentially infectious biological risk Please wear Standard laboratory protective clothing wearing gloves to comply with the provisions of the safe operation of laboratory Warning User have the obligation to abide by local national waste water discharge of relevant provisions cleaning Cleaning operations play a clean sample needle WBC count pool RBC count the role replacement swabs associated piping In the main menu touch System maintenance key enter the system maintenance interface Touch clean pipe key to enter the cleaning process e Cleaning replacement swabs When the instrument work for 30 days or count accumulated up to 2000 samples we recommend users to clean swab When the machines work 300 days or a total count of 30 000 samples we recommend users to replace swabs e Packing When the instruments need more off site of distant metastases the need for the implementation of packaged process equipment 1 Emptying liquid Rd 2 Washing with distilled water pipe 3 Emptying pipe 4 Fixed sampling needle up and down components before and after exercise 37 BGT BioGenTechnologies Hem o test 18RT Chapter 4 Maintenance Make sure to operate this precis
29. belt between motor M2 and rotation board Detail procedures are as below 1 Push the key as arrow s direction open right side panel of the machine as per figure 2 1 2 Find the belt where positioned between motor M2 and rotation board 3 Use scissor to cut the belt 4 Prepare all necessary reagent such as dilution hemolysin waste liquid container etc for machine s commissioning use M2 motor Linear guides 2 BGT BioGenTechnologies Hem o test 18RT Figure 2 2 Sample needle assembly e Installation environment Environment should be as clean no mechanical vibration no major noise source and power supply interference do not near the brush type motors fluorescent lights flicker and electrical contact devices Avoid direct sunlight or near a heat source and air source e Space requirement Caution Machine and reagent should be positioned on the same level This machine should be placed on lab desk and the desk should big enough to place necessary reagent Power requirement This machine required a AC220V power supply The supply voltage fluctuation is required from AC110V to AC240 The machine s frequency is 50Hz Machine should connect with correct voltage and should install proper fuse Caution Machine should connect with correct voltage and should install proper fuse 2 3 Machine installation Risk of biological contamination Samples reagents quality control materials standard materials and biologic
30. cess with the whole blood model About 1 minute later the counting results showed that screen ID Number plus one automatic 35 BGT BioGenTechnologies Hem o test 18RT Attention Fine needle aspiration samples in the sampling process the sampling needle to the bottom of the cup should not touch the sample cup to maintain the interval otherwise it may affect the accuracy of smoke like After analysis the results will be displayed on screen If the auto print is set to open recorder or printer automatically output analysis results In the counting process if it fails the fault information area will show alarm information If the room temperature below 10 C or above 35 C blood analysis results at this time will not be reliable eResults are displayed After the blood sample analysis screen will show the results of 19 parameters and WBC RBC PLT three histograms Linear range of the parameters is as follows Screen display record and print out a high limit the scope of the following Parameter Display Range High Parameter Display Range High Limit Limit WBC MCV PDW 3 6 Power off Instrument inhale 1 3ml E Z liquid to soak the Counting Pool for 20 minutes and then cleans the pipeline Entering the main interface figure 1 11 press power off button or Power button figure 1 10 automatically Users can press Stop button to end soaking early after 5 minutes soak and then cle
31. d the instrument and reagents and it is convenient for the doctor to operate The instrument is not allowed to be placed in the position where the operator can hardly press the power switch Environment the instrument should be placed under Environment temperature 10 C 35 C Relative humidity lt 85 Atmospheric pressure 70 0kpa 106 0kpa Voltage of power supply AC110v AC240v Frequency of power supply 47Hz 63Hz 4 Description of instrument s biological hazard Operator should prepare a special vessel for the waste liquid And the waste liquid can only be put into the vessel Operator should handle the waste liquid vessel as the ruler of the lab Specimen reagent and waste liquid have the potential danger of biological hazard So the operator should wear protect clothes and love and the operator should do the experiment as the lab s rulers Requirement of instrument s repair If there is any trouble please call our company s after service department Without our company s permission the repairman not confirmed by our company can not repair the instrument Otherwise our company will not be responsible for any damage All the components except print paper cuvette and some other consumptive material should be provided by our company Otherwise our company will not be responsible for any damage The type of fuse X 1 5x20 Capacity AC250v F2Al or ACI20V F3AI 60
32. e instrument as introductions and maintain it periodically for long time working and reliability The pollution caused by the overflow and leakage will not only impact on the analytical results but also the function of the instrument therefore the overflow and leakage should be wiped immediately and air drying is avoided If there is leakage inside ask operator or serviceman to repair it This chapter gives the maintenance of the pipelines and the detection method of other parts System Maintenance has 9 parts including cleaning pipelines excluding stoppages emptying count pool high voltage ignition replacement of diluent replacement of hemolysin perfusion of counts pool reset of electric motor valves pumps test electric motors test aging test packaging etc figure 4 1 System maintenance Q Figure 4 1 Press the button according to customer s requirement 38 BGT BioGenTechnologies Hem o test 18RT Chapter 5 Setting Our sales and service personnel will install and test machine before customer use it For the convenience of users lots of parameters can be reset in order to meet the needs of different laboratories Setting includes Print Format Version Time adjustment Gain System Setting Password and Reference Ranges totally 7 options Press OK button enter the setting interface figure 5 1 Figure 5 1 5 1 Printing Setting After opening the machine Print mode is manual mode then press print set
33. e per day If specimens tested everyday is less than 100 HB contain enzyme liquid dip for washing is operated every three days 59 BGT BioGenTechnologies Hem o test 18RT If the instrument has been working for 24 hours HB contain enzyme liquid dip for washing should be done in a day Add the silicon oil hibricant path every 2 months in order to make the instrument work for a long time Dishlled water washes the bottle of hemolysin and the groupware of the cover of the bottle every 2 months in order to protect pollution 4 Restart If the instrument is shut down by power cut please restart the machine after 30 seconds Transportation Storing and Description of Biological Hazard 1 Obligation of transporter Instruments can be transported by common vehicle and should be avoid to be exposed to sun and rain 2 Description of lifting and carrying the instrument As a precision lab device this instrument should be lifted up with two hands from bottom to move When it is carried the instrument should be put into a packing chest which is surrounded by anti vibration pad 3 Placement of the instrument The instrument should be placed to prevent dust sunshine big noise mechanical shock and power interference And it should be put to a place which is far away form electric motor origin of hot origin of wind fluorescent lamp and electric instruments which are turned on and shut down frequently The lab table should be large enough to be place
34. eedle take 1 1ml diluted liquid Then press the Menu button to return Use capillary pipette to take 20ul peripheral blood and then put the blood specimen into diluted liquid quickly to make diluted blood specimen Needle should be stung deeply and use paper towel to wipe the first drop blood Shake the specimen well proportioned lay it still for 5 minutes and then shake it again Put specimen down the sample needle and then press the Start button to begin 6 Shut Down After a day s test Shut Down program must be operated by HB Wash Liquid Wait for about one minute the power supply can be turned off when you see the prompt in the screen NOTICE Environment Requirement Environment is dustproof Power code should be earth connected well ground voltage 15 less than 0 5 V Temperature should be between 10 35 and air conditioner is needed 2 Handling Troubles If plugging holes Voltage of the small hole rises please press the key Clean on the small keyboard to drainage if the situation is still please turn to Menu for Maintenance and take the order of Calcination gem hole drainage to back flush gem hole and then start background count again if plugging hole seriously please make the operation mentioned above over times if the problem still can not be solved please contact our post sale staff 3 Maintenance If specimens tested everyday is over 100 HB the head of test liquid dip for washing is operated onc
35. equence j Vers azalar a 6 00 4 00 10 00 10 0 00 6 20 4 00 1143 5 Histogram Sample sid 000 0 10 1 50 joai Display area Gran 000 2 00 T 80 10 information LTY 200 ALO x Bids 60 2 0 iW Crank 5060 T x BCH 110 TO RL ABC REC 000 350 6260 10 7 L HET 0 00 0 37 Bi L L ICY a 80 100 IL ACH 26 0 S35 0 Pe Result display NCHC 510 az ST g L EDF cw 6 0 11 0 16 0 1 PLT area RDF sd LU 34 0 56 0 fL PLT 0D 300 109 L Arv 0 T 4 ILE IL L L 10 0 722 0 4 batch Fr e di ready a E es m e e r BS e Figure 3 2 e State indication area In the lower left quarter of the screen from left to right sampling type measurement mode system state see picture 3 2 sampling type BATCH and SINGLE sampling optional Measurement mode WHOLE BLOOD and PRE DILUENT optional System state READY Enter MODE SET in measurement interface to set the mode B measure Blood S measure Pre dilute Figure 3 3 Press the relevant button the selected item indicates dark gray return to the measurement interface after set the state set succeed at the same time e Background detection Background detection should be run when power on cleansing and when next item No is 0 Background range as followed 28 BGT BioGenTechnologies Hem o test 18RT lt 0 2x109 L lg L lt
36. erform test mode setting Grey background means functioning B measure Blood S measure Pre dilute lie Figure 1 12 test mode setting interface Backspace Press this key can back to main menu interface Counting area this area display all the parameter s test value and reference value and warning etc eMenu display system hel Power line ation finng detail informahon t 5777 valve pump block te sting testing e gement srs line poa uU system setting printing se thing motor reset change diution change hemolysin Hi parame ter setting add pre dilution probe solution pre diluton te tt AD reference value parameter setting wr ave form editing HE calibratio Back to EX W setting PLT data AD data collecting pipe man editing d Figure 1 15 Main menu 21 BGT BioGenTechnologies Hem o test 18RT Chapter 2 Installation 2 1 Package Check machine outer package carefully and see whether the package was broken during transportation and then open the machine to check machine s packing list If there is anything missed or not comply with per packing list Please contact with our after sales service or our distributor in your local market 2 2 Installation requirement night side door nght door lock Figure 2 1 Right door lock e Attention on first case opening In order to avoid damage for infeed needle during transportation please cut the nylon s
37. etting interface 8 3 Pre diluents Parameters Setting The operation method of pre diluents parameters setting is the same as 8 2 8 4 Automatic Calibration Backup bottom 8 5 LJ Quality Control Press LJ quality control bottom then come to the LJ quality control interface as the image below shows Serial 20100831 measure Figure8 3 LJ QUANLITY CONTROL 52 BGT BioGenTechnologies Hem o test 18RT Get the blood sample ready if the samples are new press setting bottom in the right corner of the interface then come to the dialog box as the image below shows 1 Press add bottom add a record of the new blood sample in the dialog box double click the relevant rank for example VVBC then input the target value after that press back bottom 2 Put the blood sample on work station 1 then press begin bottom the difference of measurement will display on the image The central line is the target value Image8 4 QUALITY CONTROL SETTING DIALOG 8 6 XB Quality Control The operation of XB quality control is the same as LJ quality control but XB quality control should take the average value among three times of test 8 7 Restore Default Settings The equipment should be calibrated and in the best condition before leaving the factory and the set parameter should be default values Pressing restore default settings bottom can bring you to the default values Caution The dat
38. harge of the relevant provision 26 BGT BioGenTechnologies Hem o test 18RT eCheck fluid lines and cables Check diluents hemolytic agent waste water pipe is bent the connection is reliable Check if the power plug of the instrument is connected the socket safely e Check Recorder Printer Check the papers of Recorder Printer are adequacy the installation is in place check whether the printer power supply into power outlet whether the printer cable to connect with the host 1s ready Note when power supply of the external printer is open the instrument will auto identify test report need to be printed to an external printer inner thermal printer is invalid need to be printed in the inner thermal printer please turn off the external printer power supply 3 2 Boot Process If equipped with an external printer press the printer power on verify the printer is ready Host Boot Process 1 Open this instrument host power 2 Self test screen display will be shown as Figure 3 1 the system automatically detect the hardware cleaning pipes doing this at the end of measurement 3 After the self test process into the counting interface O BGT BioGenTechnologies Hem o test 18R T Figure 3 1 3 3 Count Interface Press Count Instrument on the main menu to enter the count interface And press Back to main menu see figure 3 2 21 BGT BioGenTechnologies Hem o test 18RT EC CE E 00000039 S
39. he scope then will be considered a clinical abnormalities The operator can reset the top and bottom limitation of 19 parameters Once the measurement results is more than range then there will be H or L marks in the measurement results back of display output printer output or recorder output to show the test results over range On the main interface please press Service Reference Edit press Category to select the reference you want the selected reference will be the new reference and then press Back to save the data and exit 42 T BGT BioGenTechnologies Hem o test 18H Press the related parameter directly and modify it the chart below lists the relevant Reference data chart selected Normal Min Min Parameter Max Parameter Max nye los o mdi 206 350 550 so ecr 100 no m 5 7 User name set Use name setting is to set up the hospital name As below 5 1 image showing press User name set and then dialog box pls enter hospital name please edit the hospital in the box and press OK when finishing edit Enter the hospital name xj Figure 5 10 The dialog box to edit the hospital name Chapter 6 Sample management This model has the huge storage of 20 000 patient results with histogram and the system can save the patient result automatically after the testing Operator can review all of the patient result parameter and histogram and print the data by the
40. ime of the volume of parts will be changed In certain procedures under the control of chemical reactions can reveal WBC three categories lymphocytes intermediate cells and neutrophils Lymphocytes is the smallest white blood cell after the reagents they are mainly distributed in the volume of the size range of 30fL 851 Lymphoid and myeloid cells are intermediate between eosinophils basophils mononuclear cells Add a hemolytic agent they are mainly distributed in the volume of the size range of 85fL 125fL Neutrophils are the largest white blood cells after mixed the hemolytic agent cell membrane damage the release of the cytoplasm the residual cytoplasmic particles are compressed between the nucleus and cell membrane damage In general after the hemolytic agent the volume of neutrophils distribute within the 125fL By direct measurement of cells through the holes when the pulse height distribution of holes to get WBC size distribution histogram obtained by the following formula for the percentage of classification PL Ly PL PM PG x100 10 BGT BioGenTechnologies Hem o test 18RT PM Mid PL PM PG x100 PG Gran PL PM PG x100 PG The cell number in the neutrophil cell region Ly Mid Gran can be obtained by calculating of the following formula Lymph x WBC Ly 100 Mid x WBC Mid 100 Gran x WBC Gran 100 Hemoglobin HGB unit After being added to hemolytic agent for the
41. in the upper right as below Query mode Input query condition 011 1 14 Query Show all Print sel item detailed info a a Wir onan 1 1v mD crios Rec 00000816 7 21 2 43 0 76 4 02 33 7 10 5 55 7 116 3 66 000000817 f Fh 2 53 1 11 4 11 32 6 14 3 53 0 135 4 26 LL E oso sto TE CT ar 000000819 0 00 0 00 0 00 0 00 0 00 100000870 TrA 2 49 0 83 4 42 32 1 10 7 57 2 158 5 06 0000008621 8 13 2 51 0 76 4 06 30 8 9 4 59 8 157 4 98 Figure6 3 The interface of Sample management and two bottom Print the selected and Detail on the upper right 45 BGT BioGenTechnologies Hem o test 18RT Touch and press Print the selected and start to print 3 3 Patient Detail Touch and press Detail to enter the interface of Detail as below Basic information Histogram Name Branch medicine gt ID 00000818 Sex fo Checker v Numberlli1 Age UNUN Sender y Code 003003082455 date 2010 10 21 Type Do Result of measuring WBC 7 75 MCV o Ly 2 40 MCH 29 oso McHe 354 GR 474 Row cv 22 7 0 Lv o RDW SD 69 6 MOX 8 PLT o GR 6112 MPV 0 0 RBC 427 PCT 00 previous Next HGB 141 PDW 10 0 Print Return HCT 10 40 Super user Figure Detail Interface Detail interface displays the selected stored data The basic information such as name gender is displayed in the up
42. internal thermal printer and the external printer and also the data can be deleted and checked and the checked result can be displayed in the form of a list or the singular patient result with histogram 43 BGT BioGenTechnologies Hem o test 18RT 6 1 Sample review ig On the main interface press Sample management F e Man Lr 2 to enter the interface of Sample management as below showing Sample management is purposed to provide the function for the operator to check the stored data calculate CV and histogram displaying sample management Input query condition 011 1 14 show all Print sel item detailed info w sick wec mma orane Ma RBC 100000816 3 66 100000817 4 26 100000818 4 27 100000819 0 00 100000820 5 08 000000821 4 98 000000822 3 03 100000823 4 77 100000824 0 00 100000825 0 00 100000826 4 29 100000827 4 46 100000828 4 42 000000829 3 06 100000830 4 06 100000831 6 12 100000832 4 26 100000833 4 04 100000834 3 06 100000835 0 74 n Figure 6 1 The interface of sample management Data Query 1 Select the query Way At the upper left of the Sample management interface Query Way can be founded and its relate box below can provide the query ways as below 44 BGT BioGenTechnologies Hem o test 18RT m mode Input query condition
43. ize 70um Diameter 60um Length Test time less than 60s once e Performance Index Parameter Indication Comparability Linearity Linearity Error Repeatabili range Range ty CV WBC 109 L 0 99 9 lt 0 5 10 0 lt 0 5x109 L lt 10 1 99 9 RBC 1012 L 0 0 9 99 lt 2 5 0 00 1 00 0 05x1012 L lt 1 2 PLT 109 L 0 999 lt 8 10 100 lt 10x109 L lt 4 101 999 lt 1 1 HGB g L SEA 20 70 lt 29 L Y e Indication 8inch TFT colourful LCD resolution ratio is 640 by 480 e Input and output One RS232 C interface Use this interface to connect the computer for serial communication and upload the data and transmit the computer control order One standard PC network interface Use this interface to connect the computer for network communication and upload the data if necessary the software transporting is available One PS2 keyboard interface This interface can be used to connect the standard keyboard to transport the data One PS2 mouse interface It is used to connect the standard mouse One print interface Standard collateral print interface can connect the EPSON LQ 300K and the outside stylus printer Two USB interface After setting the driver programs it can be used to connect the printer outside which has a USB interface It also can be used to import and export the data e Built in thermal record instrument Beijing Wei Huang WH A76R90 e Outside printer EPSON LQ 300K e Reagents Dilution
44. l RBC Hemoglobin HGB Number of platelets PLT Results obtained by histogram Lymphocyte percentage Intermediate cell percentage Neutrophil percentage Mean red blood cell Volume Red blood cell distribution width standard deviation Red blood cell distribution width coefficient of variation Mean platelet volume Platelet distribution width Platelet hematocrit Results obtained by calculation Number of lymphocyte Number of intermediate cell Number of neutrophil Red blood cell hematocrit Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration eHemoglobin measurement principle Absorbance of hemoglobin Central wavelength 540nm eSample characteristics puncture sampling sample volume required for each analysis Whole blood sample venous 13uL Pre diluted sample peripheral blood 20uL Volume calculation 300uL the second diluent each time RBC and PLT measurement Hemolytic agent volume Dilution ratio Whole blood Periphery blood WBC HGB 1 270 1 263 RBC PLT 1 45000 1 45000 ImL whole blood ImL peripheral blood 109 L 1012 L g L 109 L Ly MO GR MCV RDW sd RDW cv MPV PDW PCT Ly MO GR HCT MCH MCHC 400uL add hemolytic agent diluent each time WBC measurement Hem o test 18RT Yo L L 109 L 109 L 109 L L L pg g L 14 BGT BioGenTechnologies Hem o test 18RT Micropore size WBC micropore size 70um Diameter 70um Length RBC micropore s
45. m o test 18RT FAX 02551 1298 ADD Von Langen Weg 10 D 48565 Steinfurt APPENDIX 2 Hem o test ISRT MENU Hem o test ISRT MENU testi service 7 sample i QCealibration TUNE maintenance management setting pipe line evacuation finng detail information Pome valve puimp black te sting testing pin code EXW setting CHEN management meme osa evaluation illing pool po system setting printing se ting a change dilution change hemolysin parameter setting add pre dilution prose sa hon FORME pre dilution arameter sett AD reference value P ing wave form editing X E calib rato Back to EX W setting PLT data AD data collecting editing DOR E 55 BGT BioGenTechnologies Hem o test 18RT APPENDIX 3 Hem o test ISRT Circuit Diagram ui coe lini D PREP 56 Hem o test 18RT BGT BioGenTechnologies APPENDIX 4 Hem o test ISRT Power Panel Schematic Diagram 1102 ATACTOUTId 11500 Iamod au FS rur pr Ses ww ap ad Lu 57 BGT BioGenTechnologies Hem o test 18RT APPENDIX 5 Copyright Statement Copyright BGT BioGenTechnologies GmbH 2010 Number of edition 1 0 Date of publish May Ist 2010 Product instrument Hem o test 18RT License NO Permission for medical device production issued by Jiangsu Food and Drug Administration 2001 0750 Register NO Jiangsu Food and Drug Administration 2010 2400967 Standard operated NO YZB Su 0851 2010 Statement
46. ood samples as picture 5 8 illustrating WBC passageway gain is little so need to add WBC passageway gain When most blood samples as picture 5 9 illustrating WBC passageway gain is large so need to decrease WEC passageway gain eRBC passageway gain settings When MCV measured value of QC and set value have over 5 deviation then need to alter RBC passageway gain to adjust MCV measured value Adjustment ratio as below MCV QC reference value 90 0fL MCV QC measured value 98 0fL Setting adjustment rate of RBC option to be most close to value of 91 8 eHGB passageway gain settings By adjusting HGB passageway gain to change HGB background voltage To adjust HGB background voltage between 4 4 4 5V 5 4 System settings In settings interface press system setup key and then enter system setup operation interface as picture 5 8 41 BGT BioGenTechnologies Hem o test 18RT Figure5 8 Clicking directly all kinds of parameters to set 5 5 Password setup ot pre beet bein ksr First Password New Password Reenter new password Figure5 9 In settings interface pressing password management key and then enter into input password operation interface like picture5 9 According to the requirement to input correctly and then can set password successfully 5 6 Reference value Laboratory is based on normal group settings normal reference value range see picture 5 10 to 5 14 1f the measured results is more than t
47. per left and the tested result is displayed in the below left histogram of WBC RBC PLT shows on the right size On the below right there are six buttons Previous Next Print Back Super User and Modify and Save Press Previous the data of the previous patient will be displayed Press Next the data of the next patient will be displayed Press Print the data of the selected patient will be printed Modify and Save the patient data Touch Super User the dialog box will be popped to ask for the passwords and enter the password and press Confirm when the passwords is valid the user can modify the results and the button Modify and Save is active press it to save the modified result 3 4 Calculate CV As the image 6 1 showing the interface of sample management there is a box on the left size of the chart please touch and select some results for calculation and press Calculate CV and the calculation is finished 46 BGT BioGenTechnologies Hem o test 18RT And the user can check the calculation result by touching and pressing the scroll bar on the below of the chart Press Back to be back to the previous interface Chapter 7 Service When the customer has purchased our product our sales and post sale personnels will help to set up and test the machine for our clients To provide more convenience to the user our own system can support some necessary
48. rameter Repetitiveness CV WBC 7 0 15 0x109 L 5 RBC 3 5 6 0x1012 L 212 HGB 110 180g L lt 1 1 MCV 80 0 110 0fL 4 0 5 PET 100 500x109 L lt 4 Please get record of every calibration records include calibrated date batch number of the calibrated items standard value of the calibration the test value of WBC RBC PLT HGB and MCV 8 2 Whole Blood Parameter Setting Press whole blood parameter setting on the quality control calibrated interface as image 8 1 shows then come to the whole blood parameter setting interface as the image below shows users can use whole blood parameter setting to narrow the difference when there exists greater error But this should be done by professionals otherwise the equipment will not work well Press the parameter that you want the change You will see a number keyboard input the figure then press enter bottom HGB bottom is used to set the target value of the sample after that press calibration bottom The equipment should be calibrated and in the best condition before leaving the factory and the set parameter should be default values Pressing restore default settings bottom can bring you to the default values 5 BGT BioGenTechnologies Hem o test 18RT om Paremeter Tom Paremeter WBC 1 00 RBC 1 00 PLT 1 00 LY 1 00 MCV 1 00 MPV 1 00 MOS 1 00 RON CV 1 00 POW 1 00 HGB 180 fe y x A HOR Adat Figure8 2 whole blood parameter s
49. s bar will close itself Liquid waste disposal Biological Pollution sample reagent quality control staff standard staff and waste liquor have the potential danger of biological infectivity Users should wear Warning o Users have the obligation to abide by the stipulation about the waste liquor discharge Chapter 8 Quality Control Calibration The quality control equipment is used to ensure the accuracy of the test value Press quality control bottom on menu interface then come to the quality control interface as the image below shows there are 6 bottoms in it whole blood parameter setting pre diluents setting automatic calibration LJ calibration XB calibration and restore default value Blood para set Figure8 1 Quality control calibration interface 50 BGT BioGenTechnologies Hem o test 18RT 8 1 The Preparation of Calibration Use the calibrated staff and quality control liquor offered by our company the calibration will go automatically This equipment includes whole blood mode and pre diluents mode two calibrated parameter will come out automatically The equipment must have been checked whether it is in normal situation before the calibration If any problems emerge stop the operation Check whether the reagent and other auxiliary staff is enough Check the samples and make sure the test value is reasonable Test the samples repeatedly and make sure the equipment in its accuracy range Pa
50. scanning Intelligent volume Automatically send samples automatic mixing device automatic intelligent maintenance system automatic cleaning automatic Hem o test 18RT rule out the block and automatic maintenance of enzyme cleaning solution reagents automatic temperature control system intelligent Fault Alarm System Micro computer keyboard and mouse Precision screw drive mechanism Support on line network data transmission support serial data communications Intelligent voice prompt system 8 inch 800 x 600 TFT color LCD screen panel type thermal printer built in puncture sampling and dilution devices intelligent bar code scanning Intelligent volume Automatically send samples automatic mixing device automatic intelligent maintenance system automatic cleaning automatic Hem o test ISRT rule out the block and automatic maintenance of enzyme cleaning solution reagents automatic temperature control system intelligent Fault Alarm System Micro computer keyboard and mouse Graphical touch screen operation Precision screw drive mechanism Support on line network data transmission support serial data communications Intelligent voice prompt system eCount and volume calculation principle Small hole resistance method e Parameter explanation Parameter Abbreviation Unit Basic parameters 13 BGT BioGenTechnologies Number of white blood cell WBC Number of red blood cel
51. service functions for option Our service function includes diluting Probe liquid immersion thick enzyme immersion Change the diluents and hemolytic or other optional On the main interface press Service to enter the service interface Services Image 7 1 Service 7 1 A D wave Press A D wave to enter the interface of A D as the image7 2 shows This interface is mainly to display the tested data wave or A D data acquisition 47 BGT BioGenTechnologies Hem o test 18RT Figure 7 2 A D wave interface Used to display the measured data wave or the A D data acquisition wave 7 1 1 The Display of WBC DATA Click the WBC DATA bottom and then you will see the WBC DATA interface as the image 7 3 shows click the leftward or rightward bottom in the right corner to display the former or the later data wave Data Length Current Position dq Image 7 3 VVBC DATA INTERFACE The Display of RBC DATA same as 7 11 The Display of PLT DATA same as 7 11 A D DATA ACQUISITION Click the A D DATA ACQUISITION bottom the system will collect the data automatically 7 2 The Edition of Reference Value Click edit reference value bottom on the service interface as image 7 1 shows then enter edit reference value interface as the image shows below 48 BGT BioGenTechnologies Hem o test 18RT MCHC RDW CV 7 4 Item inferior limit of the reference value the superior limit
52. ting Figure 5 2 Set print Set Outer config Print English Don t print Figure 5 2 39 BGT BioGenTechnologies Hem o test 18RT Print choice built in printer external printer Choose built in printer press print key built in heat sensitive recorder output result 5 2 Date and time set In settings interface click time set at first appear hour settings dialog box Present Time Zone China Standard Time Using mouse or touch screen to set after ending settings and then pressing confirmation key then finishing time set 5 3 Gain set Set Amplifier Set S Amplifier Value Voltage value Measure mode WBC WBC RBC B ie HGB Subpressure PLT HGB 12 Figure 5 4 Pressing gain settings to enter picture 5 4 gain set interface for WBC RBC PLT HGB passageway gain 12V5 settings In the interface to input directly corresponding number for gain settings Paying much attention to is that unauthorized personnel shall not engage in this operation must input password and then can be set Input password x Input password Cancel Figure 5 5 40 BGT BioGenTechnologies Hem o test 18RT e WBC passageway gain settings Adjustment WBC passageway gain to be aimed at adjusting WBC column diagram shape W B Nes lu O 50 100 150 200 250 fL Figure5 6 B DEN i J T T i T T T O 50 100 150 200 250 fL Figure5 7 When most bl
53. trument printer interface before the instrument boot After the device boot open the printer power supply when operating print the result data is automatically output to an external printer For the specific installation use of the printer see the printer manual 25 BGT BioGenTechnologies Hem o test 18RT Chapter 3 Blood Analysis This chapter contains six elements Operational Readiness Power On Count interface Blood Sample Collection Blood Count Power off 3 1 Operational Readiness Before the power is turned on the operator shall check according to following steps these steps will ensure that the system is ready completion of these checks will help the normal operation of this instrument eCheck diluents hemolytic agent The dosage of the various reagents PL 6A Hemoglobin and no PL 6A Washing liquid Leukocyte Diluents distilled water Operation Analysis of Hemolytic Agent EI CO CI CI Power Power off Wash VVash Block peer Replace or Priming or Priming eCheck the waste barrels Users bring their own waste barrels discard the waste liquid in the waste barrels Risk of biological contamination Samples reagents quality control materials standard materials and waste liquid etc have the risk of potentially biological infectious Should wear standard laboratory protective clothing gloves and comply with the Warning User obligation to abide by local national waster water disc
54. uent the volume distribution are as follows WBC 30 400 fL RBC 25 250 fL PLT 2 30 fL As the volume difference the instrument can be counted in the same pool according to the level of electrical pulses respectively of RBC and PLT counts In Image 1 2 A representative of PLT plus signal B and D representative of RBC signal C compared with the PLT pulse signal is too small and considered a circuit instrument noise or cell debris collected in the normal threshold setting A as to be PLT count C have been removed It seems that the volume of PLT and RBC are significantly different in fact each cell has a range of volume distribution forming a bell curve they cross the curve close to each other sometimes crossing the curve a large extent be used special measures to distinguish between RBC and PLT The instrument approaches with BGT BioGenTechnologies Hem o test 18RT floating boundary markers to distinguish between RBC and PLT to improve the accuracy of measurement results eWhite blood cell WBC unit Structure S Hemolysin pipe electiode of the front HGB Ligh source Image 1 3 WBC cell structure e White blood cell WBC unit Obtained by direct measurement of pulse number WBC nx10 L e WBC classification WBC according to the size of the volume it has a variety of forms while the volume of the size of various forms of WBC is not fixed as diluent hemolysis and hemolytic agents on the t
55. uman factors and subjective to reduce the statistical error to fully enhance the accuracy of the count Control of the test sample e Volume measurement A certain amount of diluted sample respectively flows through the RBC 70um and WBC 70um aperture diameter pores were counted using the time to calculate the volume of the instrument the vacuum in certain circumstances the amount of fluid flowing through the hole and time is proportional to Sample dilution In the blood all kinds of cells overlap so that it can not be accurately counted and measured the size of the volume so the use of diluents on blood samples need to be diluted the diluted blood cells of a single hole through the hole while providing conductive environment for the count To completion of cell number and volume measurement In the condition of whole blood mixed with 13uL whole blood and 3 5mL dilution the sample will be 1 270 The 1 270 diluted sample into two parts Take 15 6uL the 1 270 diluted sample and 3 9mL of the diluted solution mixed to form 1 45000 sample and to measure and count red blood cell and platelet Leukocyte will dilute 0 5MI the rest of the hemolytic plus ImL diluted mixed form 1 385 sample and to measure and count Leukocyte BGT BioGenTechnologies Hem o test 18RT In the pre diluted mode take 20uL Peripheral blood and 1 1 mL Diluted mixed outside dilution to forma 1 81 sample Suck 0 7ml s 1 81 sample and mix in WBC pool Then
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