BF-6500 Automatic Hematology Analyzer User Manual 1111

BF-6500 Automatic Hematology Analyzer User Manual

Instruction: Dear user, thanks for choosing our BF-6500 Automatic Hematology Analyzer. Please read the user manual carefully before use in order to operate the instrument correctly. Please keep the user manual safely for your any time reference.

Warning: ●An independent power supply is a must. Electromagnetism interference will affect the accuracy of the test result. ●Don‘t pull the electrical wire with wet hand, or there is a risk of electrical shock. ●Don't stamp, twist, drag the wire and cable, or it may cause a fire. The damaged wire and cable can not be used. ●The instrument must be used in good grounding condition. ●The input power should conform to instrument requirement. Specified fuse should be used. ●Make sure the switch is on [O] state before connecting the power. ●It can not be used in flammable and explosive environment. ●DO NOT touch moving parts when the instrument is testing to avoid accident. ●Non-professionals can not open the left, right and upper cover of the instrument when the main power is ON. ●Make sure the instrument is used under the condition that is specified in user manual. In improper condition, the instrument may not work well, the result may be inaccurate, instrument component may be damaged and personal security is endangered.

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Note: ● Instrument should be operated by medical inspection specialist, physician, nurse or lab assistant whom are specially trained. ● Maintenance plan of hospitals and inspecton bodies should be prepared and followed. ● Instrument should be controlled by special software specified by DIRUI. Other hardware or software installation may affect the normal working of the instrument. ●Expired reagent can not be used. The reagent should be protected from dust, dirt and bacteria once opened. ●Soft cloth or gauze can be used for cleaning work. A little diluted detergent and alcohol can be used if necessary. Pine oil and benzene can not be used for outside cleaning, it may cause color and shape change. ●Outdoor temperature in winter is quite low. The analyzer should be placed at room temperature for at least 24 hours before power on.

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Biohazard Marking: ●Please dispose the reagent, waste solution, waste sample and consumable according to the local regulation. ●Sample, Control, Calibrator and waste solution have potential biochemical infectivity that may hurt eyes, skin and mucosa. Operator should refer to the safety regulation for lab operation. Protective measure should be taken (Such as lab protective clothes and gloves). ●Please dispose the waste solution and instrument consumable according to the regulation of medical waste, infective waste and industrial waste. Blood in the waste may have been contaminated by pathogens. ●Avoid reagent contact with eyes and skin, in case of any contact, rinse immediately with plenty of water and seek medical advice if needed. ●Sampling probe is sharp-pointed which may with some material have potential bio-infectivity, such as blood sample, Control and Calibrator. Contact with sampling probe should be avoided. In sampling, there should be a certain distance between probe tip and the wall of the container to avoid blood splash. Or the accuracy of aspiration volume may be affected. ●Avoid direct contact with the patient's blood. ●Disposable supplies can not be reused.

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Content Chapter 1 Brief Introduction............................................................................................................................1 1.4.1 Front Picture.........................................................................................................................................13 1.5 External Devices..........................................................................................................................................14 1.6 Symbol .......................................................................................................................................................15

Chapter 2 Installation ....................................................................................................................................16 2.1 Installation Requirement..............................................................................................................................16 2.2 Unpacking ...................................................................................................................................................17 2.4 Software Uninstallation...............................................................................................................................25 2.5 Software Login............................................................................................................................................26 2.5.1 Login Software.....................................................................................................................................26 2.5.2 Counting Interface................................................................................................................................28 2.5.4 Log Out.................................................................................................................................................30

Chapter 3 Instrument Setting .........................................................................................................................31 3.1 Sample Information.....................................................................................................................................32 3.2 Sample Registration.....................................................................................................................................33 3.2.1 Edit Patient Information.......................................................................................................................33 Copy Patient Information .............................................................................................................................37 Modify Patient Information...........................................................................................................................37 Delete Patient Information............................................................................................................................37 Mask..............................................................................................................................................................38 Query.............................................................................................................................................................38 3.3 Setting..........................................................................................................................................................38 3.3.2 Administrator User...............................................................................................................................44

Chapter 4 Normal Operation..........................................................................................................................58 4.1 Preparation before Operation.......................................................................................................................58 4.2 Daily QC......................................................................................................................................................59 4.3 Sample Preparation......................................................................................................................................59 4.3.1 Whole Blood Sample Preparation:.......................................................................................................59 4.3.2 Preparation Method of Pre-dilution Sample (Peripheral Blood)..........................................................59 4.4 Sample Testing of Whole Blood Mode .......................................................................................................62 4.4.1 Changing Test Mode and Sample No...................................................................................................62 4.4.2 Sample Information Editing.................................................................................................................63 4.4.3 Sample Testing Steps............................................................................................................................63 4.4.4 Picture Check.......................................................................................................................................65 4.4.5 Research Parameter Check...................................................................................................................66 4.6 Sleeping.......................................................................................................................................................69 4.7 Rinse and Clog Removal.............................................................................................................................69 IV


Chapter 5 Record Query................................................................................................................................71 5.2 Print ............................................................................................................................................................73 5.3 Query...........................................................................................................................................................75 5.3.1 Query Accroding to Sample No. .........................................................................................................76 5.3.2 Query According to ID Number...........................................................................................................76 5.3.3 Query According to Test Mode and Date ............................................................................................76 5.3.4 Query According to Case No. ..............................................................................................................77 5.3.5 Query According to Name and Sex .....................................................................................................77 5.3.6 Query According to Department and Deliver Doctor .........................................................................77 5.3.7 Query According to Auditor ................................................................................................................77 5.3.8 Query According to Checker ...............................................................................................................77 5.4 CV Calculation............................................................................................................................................77 5.5 Bulk Audit ...................................................................................................................................................78 5.6 Communication...........................................................................................................................................79 5.7 Delete...........................................................................................................................................................79 5.8 Export..........................................................................................................................................................80 5.9 Chart Query ................................................................................................................................................81

Chapter 6 Quality Control..............................................................................................................................82 6.1 L-J QC.........................................................................................................................................................82 6.1.1 Quality Control Setting........................................................................................................................83 6.1.2 QC Counting.........................................................................................................................................86 6.1.3 QC Result Review................................................................................................................................87 6.1.4 QC List.................................................................................................................................................90 6.2 QC................................................................................................................................................................91 6.3 X-B QC........................................................................................................................................................91 6.3.1 QC Setting............................................................................................................................................92 6.3.3 QC Graph Review................................................................................................................................93 6.3.4 QC List Review....................................................................................................................................95

Chapter 7 Calibration.....................................................................................................................................97 7.1 Calibration Frequency.................................................................................................................................97 7.2 Calibration Method......................................................................................................................................97 7.4.1 Fresh Blood Preparation.....................................................................................................................100 7.4.2 Fresh Blood Calibration.....................................................................................................................100 7.5 Manual Calibration....................................................................................................................................103 7.6 Calibration Log..........................................................................................................................................104

Chapter 8 Service..........................................................................................................................................105 8.1 Maintenance Guide....................................................................................................................................105 8.1.1 Regular Maintenance ........................................................................................................................105 8.2 System Status.............................................................................................................................................106 8.2.1 System Version...................................................................................................................................106 8.2.2 Basic Status........................................................................................................................................108 8.3 Mechanical Detect.....................................................................................................................................109 V


8.3.1 Motor Detect.......................................................................................................................................109 8.3.2 Valve Detection..................................................................................................................................109 8.3.3 Pump Detection..................................................................................................................................110 8.4 System Maintenance..................................................................................................................................110 8.4.1 Replacement / Priming.......................................................................................................................110 8.4.2 Rinsing................................................................................................................................................114 8.4.3 Maintenance........................................................................................................................................116 8.4.4 Reagent Registration .........................................................................................................................122 8.5 Replacement of Wearing Components......................................................................................................124 8.5.1 Replace Syringe Pump ......................................................................................................................124 8.6 System Log................................................................................................................................................125

Chapter 9 Instrument Transportation and Storage.......................................................................................127 9.1 Transportation Requirement......................................................................................................................127 9.2 Storage Requirement.................................................................................................................................127

Chapter 10 Failure Handling........................................................................................................................128 10.1 Overview.................................................................................................................................................128 10.2 Failure Information and Solution............................................................................................................129

Appendix B...................................................................................................................................................144 Statement......................................................................................................................................................154

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Chapter 1 Brief Introduction 1.1 Overview BF-6500 Automatic Hematology Analyzer is used in medical laboratories to quantitative analyze blood cell, carrying out 5-differential to white blood cell(WBC) counting result, and offer scattergram of white blood cell 4-diff, histogram of red blood cell(RBC), white blood cell(WBC) and platelet(PLT), histogram information of WBC 4-diff. It is a highly integrated instrument with high-capability. It characterize in accurate test result, easy operation, low consumable. The instrument can test quantitative analysis result of 24 blood parameters and 10 research parameters. Instrument is connected with computer to conduct operations. The instrument is an in vitro diagnostic medical instrument used by professionals for screening. When making clinical judgment according to the analysis result, the doctor should taking into account the clinical test result or other test result.

1.2 Specification Sample Volume: Whole Blood：

CBC+DIFF Mode：20μL CBC Mode：10μL

Peripheral Blood： CBC+DIFF Mode：80μL（diluted） CBC Mode：40μL（diluted） Aperture Diameter: WBC Aperature：diameter 80μm, depth 80μm RBC, PLT Aperature：diameter 70μm, depth 65μm Laser Tube Wavelength: 540nm Throughput:

60 T/H

Dilution Ratio: Whole Blood:

WBC/HGB 1:583

RBC/PLT 1:30000,

WBC(differential) 1：200 Prediluted: WBC/ HGB 1:5830

RBC/PLT 1:300000,

WBC(differential ) 1：2000 Lyse Volume:

SLS：0.5mL

FDT：0.2mL

FDO：1.0mL

Test Item(including research parameters)： White Blood Cell Neutrophil Lymphocyte

WBC Neu# Lym # 1

BF-6500 Automatic Hematology Analyzer User Manual Intermediate Cell

Mon#

Eosinophil

Eos#

Basophil Blasts#

Bas# Blasts#(research param)

Aty/Abn Ly#

Aty/Abn Ly#( research param)

Imm Gran#

Imm Gran#( research param)

Shift to Left

LEFT#( research param)

Nucleated RBC

NRBC#( research param)

Neutrophil Percentage

Neu％

Lymphocyte Percentage

Lym％

Intermediate Cell Percentage

Mon％

Eosinophil Percentage

Eos%

Basophil Percentage

Bas%

Blasts Percentage

Blasts% (research param)

Aty/Abn Ly Percentage

Aty/Abn Ly% (research param)

Imm Gran Percentage

Imm Gran% (research param)

Shift to Left

LEFT%( research param)

Nucleated RBC Red Blood Cell Hemoglobin

NRBC%( research param) RBC HGB

Mean Red Blood Cell Volume

MCV

Mean Red Blood Cell Hemoglobin Content

MCH

Mean Red Blood Cell Hemoglobin Concentration

MCHC

Red Blood Cell Distribution Width Coefficient of Variation RDW-CV Red Blood Cell Distribution Width Deviation Limitation Hematocrit Platelet Number

HCT PLT

Mean Platelet Volume

MPV

Platelet Distribution Width Plateletcrit Larger Platelet Cell Ratio

PDW PCT P-LCR

Diff Scattergram

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RDW-SD

BF-6500 Automatic Hematology Analyzer User Manual RBC Histogram PLT Histogram WBC Histogram WBC Diff Histogram Storage: 30000 test results; L-J/ X QC: 12 documents, 400 records/ document; X-B:1 document, 400 records Working Environment:

Temperature:15℃~30℃

Humidity : 30％~75％

Atmosphere Pressure: 75kPa~106kPa Output: RJ45 port Barcode Input: external barcode reader (equipped) Power Supply: ~220V

50Hz

Fuse: 250V 4A Power:

Mainframe: 175VA

Weight:

Mainframe: 46Kg

Dimension:

Mainframe：490mm(L)×540mm(W)×550mm(H)

Electromagnetic Compatibility: The equipment complies with EN61326 ： 1997+A1 1998+A2 2001+A3 2003 of EMC test standard, meeting A level requirements, should not be installed near devices tend to be interfered.

1.3 Working Principle This instrument adopts electric impedance to test RBC, WBC/ Basophil, PLT number and volume distribution. Test the hemoglobin concentration by using colorimetry. Adopting semiconductor laser flow cytometry to obtain WBC 4-differential counting result. The result of other parameters are calculated upon the above results.

1.3.1 Sample Aspiration The instrument offers two sampling type: whole blood and pre-dilution mode. In whole blood mode, the instrument aspirates 20μL （ CBC+DIFF mode ） or 10μL （ CBC mode）whole blood sample. In pre-dilution mode, the operator should mix 20ul peripheral blood with 180ul diluent to form a sample with dilution ratio of 1:10, and then send it to the analyzer for aspiration. The analyzer will aspirate 80 μL（CBC+DIFF mode）or 40μL（CBC mode）diluted sample. 3


1.3.2 Sample Dilution The sample is divided into 2 parts after sample aspiration. And the sample will be dispensed into WBC differential detector, WBC counting cell and RBC counting cell in order according to the test requirement. Through the effects of different reagents while dilution process, forming samples which are used for WBC differential testing, WBC/ hemoglobin testing and RBC/PLT testing. For different sample, the instrument offers two different working modes - whole blood mode and pre-dilution (Peripheral Blood) mode.

1.3.2.1 Whole Blood Mode a)RBC/PLT Dilution Process Whole Blood Sample 6μL

Diluent 3mL

Dilution Ratio 1：500 Aspirate 50μL Diluent 3mL

RBC/PLT sample with dilution ratio about 1：30000

Figure 1-3-1 RBC/PLT Dilution Process

b) WBC/Hemoglobin Dilution Process Whole Blood Sample 6μL

Diluent 3mL

BF-SLS Lyse 0.5mL

W B C / Hemoglobin sample with dilution ratio of about 1:583

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Figure 1-3-2 WBC/Hemoglobin Dilution Process

c)WBC Differential Dilution Process Whole Blood Sample 6μL

BF-FDO Lyse 1mL

BF-FDT Lyse 0.2mL

WBC sample with dilution ratio of 1：200

Figure 1-3-3 WBC Differential Dilution Process

1.3.2.2 Pre-dilution Mode a)RBC/PLT Dilution Process

Figure 1-3-4 RBC/PLT Dilution Process

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BF-6500 Automatic Hematology Analyzer User Manual b) WBC/Hemoglobin Dilution Process

Figure 1-3-5 WBC/Hemoglobin Dilution Process

c) WBC Differential Dilution Process

Figure 1-3-6 WBC Differential Dilution Process

1.3.3 WBC Testing 6


1.3.3.1 Laser Flow Cytometry At the effect of a certain amount of reagent, the blood sample is pipetted into flow cell which is full of diluent. Under the package of sheath which is formed by diluent, the single cell flow goes through the center of flow cell. As shown in Figure 1-3-7:

Figure 1-3-7 Flow Cell Blood cells go through the laser area after twice acceleration. Under the effect of laser beam, the scattered light is related to cell size, refractive index of cell membrane and cell internal structure. Low-angle forward scattered light reflects the size of cell. High-angle forward scattered light reflects the internal fine structure and particulate matter. Photodiode receive the scattered light signals and translate them into electrical pulses, according to the electrical pulses, twodimension map(scattergram) of cell size and cell internal information can be obtained. The abscissa reflects the cell's internal structure. The vertical axis reflects the cell size, as shown in Figure 1-3-8:

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BF-6500 Automatic Hematology Analyzer User Manual Figure 1-3-8 4-diff Scattergram Drawing The lymphocytes, monocytes, eosinophils and eutrophils percentage can be obtained from the DIFF channel scattergram.

1.3.3.2 WBC Number/Basophil ---- Impedance Method WBC number and basophils are counted through impedance method. The aspirated sample is dispensed into test unit after diluted by quantitative conducting solution. The testing unit has a test aperture. A pair of positive and negative electrodes exist beside the aperture for connecting the constant current power supply. As the cells have the characteristic of a poor conductor, when the cell goes through the aperture under constant negative pressure, the DC resistance between the electrodes will change, resulting in the formation of a pulse signal which is proportional to the cell size. A series of electrical pulse is produced when the cell continuously go through the aperture. The number of pulses is equivalent to the cell number through the aperture. The pulse amplitude is proportional to the cell size.

Figure 1-3-9 Counting Principle Diagram Compare the amplified electric pulse with voltage range corresponding to normal WBC size range. Calculate the electrical pulse number. All electrical pulse is classified according to different channel voltage range. Electrical pulse number which fell in WBC channel is WBC number. Cell number in each channel which is divided according to pulse voltage range determines the cell size distribution.

1.3.4 WBC Parameter 8

BF-6500 Automatic Hematology Analyzer User Manual Through analyzing Diff channel scattergram, Lym area, Neu area, Mon area and Eos area, the percentage of lymphocytes (Lym%), the percentage of neutrophils (Neu%), the percentage of mononuclear cells (Mon%), as well as the percentage of eosinophils (Eos%) can be obtained. Calculate by using the WBC number, lymphocytes (Lym #), neutrophils (Neu #), mononuclear cells (Mon #) as well as eosinophils (Eos #) can be obtained. Cell unit is 109/L.

●WBC WBC number can be obtained through testing the corresponding pulse number. ●Basophil Basophil number can be obtained through testing the corresponding pulse number. ●Basophil Percentage

B a% s =

B a #s × 1 0 0% W BC

●Lymphocyte Percentage

●Neutrophil Percentage

●Monocyte Percentage

●Eosinophil Percentage

●Lymphocytes Lym#= WBC×Lym% ●Neutrophil Neu#= WBC×Neu% ●Monocyte 9


Mon#= WBC×Mon% ●Eosinophil Eos#= WBC×Eos%

1.3.5 Hemoglobin Concentration Testing— Colorimetry SLS-hemoglobin method combined with the oxy hemoglobin method and cyano-hemoglobin method. It characterize in high hemoglobin conversion speed and no toxic substance, applicable to automatic testing instrument. SLS-hemoglobin method is needed in hemoglobin concentration testing. In colorimetry pool, the diluted sample is mixed with lyse, RBC dissolve, releasing hemoglobin. Hemoglobin combined with lyse to form hemoglobin complex. At one end of the colorimetry pool, the hemoglobin complex is irradiated by monochromatic light with a wavelength of 540nm (LED light tube). Phototube is used at the other end to receive transmission light, and convert the light signal into voltage signal. By comparing with the voltage produced by background transmission light intensity before sample adding(only diluent exists), the hemoglobin concentration can be obtained(HGB), unit is g／L. This testing and calculation process will be finished by the analyzer automatically, and the result will be displayed in the counting interface.

1.3.6 RBC / PLT Testing 1.3.6.1 Impedance Method This instrument adopts the electric impedance method to count red blood cell / platelet. RBC / platelet sample flow into RBC test unit after twice dilution. The testing unit has a test aperture. A pair of positive and negative electrodes exist beside the aperture. As the cells have the characteristic of a poor conductor, when the cell go through the aperture under constant negative pressure, the DC resistance between the electrodes will change, resulting in the formation of a pulse signal which is proportional to the cell size. A series of electrical pulse is produced when the cell continuously go through the aperture. The number of pulses is equivalent to the cell number through the aperture. The pulse amplitude is proportional to the cell size. 10

BF-6500 Automatic Hematology Analyzer User Manual Compare the amplified electric pulse with channel voltage value corresponding to normal RBC/PLT size range. Calculate the electrical pulse number. All electrical pulse is classified according to different channel voltage value. Electrical pulse number which fell in RBC/PLT channel is RBC/PLT number. Cell number in each channel which is divided according to pulse voltage range determines the cell size distribution. The two-dimensional map with cell size as abscissa and cell number as vertical axis is the histogram reflects the distribution of cell.

1.3.6.2 Size Testing Method The precise control upon sample volume that goes though the aperture during testing is the premise of getting accurate result. Quantitative injection pump ensures the sample volume that goes through the testing aperture is tested. Sample volume is determined by the running steps of motor.

1.3.6.3 RBC Parameter ● RBC Number RBC number is obtained through testing corresponding electrical pulse. Unit: 1012／L

RBC=n×l012／L

●Mean RBC Size Calculate mean RBC size according to RBC distribution histogram. Unit: fL

●RBC hematocrit, mean RBC hemoglobin content, mean RBC hemoglobin concentration Calculate RBC HCT according to the following formula, unit ％; mean RBC hemoglobin content (MCH), unit Pg; mean RBC hemoglobin concentration (MCHC), unit g/L HCT

HCT =

Mean hemoglobin content

RBC × MCV 10 MCH =

Mean hemoglobin concentration

HGB RBC

MCHC =

HGB ×100 HCT

RBC Unit: 1012／L, MCV Unit: fL, HGB Unit: g／L

●RBC Distribution Width Variation Coefficient RDW-CV is obtained through RBC distribution histogram. The volume distribution variation coefficient is in the form of percentage. 11


●RBC Distribution Width Standard Deviation RDW-SD is histogram width relative to RBC distribution histogram peak (20%), unit fl, as shown in figure 1-3-10.

Figure 1-3-10

● RBC Distribution Histogram The RBC volume distribution histogram is offered when the result is obtained. The graph that can indicate the distribution of cell population is RBC distribution histogram. Histogram abscissa is RBC size (unit: fl), vertical axis is RBC relative number (unit: 1012/L). After each counting, RBC distribution histogram can be obtained in analysis result area of counting interface. RBC distribution histogram can also be obtained through entering search interface.

1.3.6.4 PLT Parameter ●PLT Number（PLT） PLT number is obtained through testing corresponding electrical pulse number, unit 109／L

PLT=n×l09／L ●Mean PLT Volume (MPV) Calculate mean PLT volume according to PLT distribution histogram. Unit: fL

●PLT Distribution Width (PDW) PDW is obtained through PLT distribution histogram, which is geometric deviation limit of PLT volume (10GSD)

●PCT Calculate PCT according to the following formula, unit ％; PLT unit 109／L unit ; MPV unit fl

PCT= ●Big PLT Ratio（P-LCR）

PLT×MP V 10000

Big PLT Ratio is obtained through PLT histogram. 12


●PLT Distribution Histogram. The PLT volume distribution histogram is offered when the result is obtained. The graph that can indicate the distribution of cell population is PLT distribution histogram. Histogram abscissa is PLT volume (unit: fl), vertical axis is PLT relative number (unit: 10 9/L). After each counting, PLT distribution histogram can be obtained in analysis result area of counting interface. PLT distribution histogram can also be obtained through entering search interface.

1.3.7 Rinsing The instrument rinse itself automatically in each counting process, to ensure no residual sample exists.

● Internal and external wall of sampling probe should be rinsed with diluent; ● Counting pool, quantitative pump should be rinsed with diluent; ● Flow cell should be rinsed with diluent.

1.4 Instrument Structure Instrument is composed of mechanical motion, pipeline, optical, electronic control, software, etc. The appearance is as follows:

1.4.1 Front Picture

①Front Door

②Indicator(yellow-failure status indicator, green-running status indicator, red-

power indicator from left to right)

1.4.2 Rear Picture

③Sampling Probe ④Sample Aspiration Key

Figure 1-4-1 Front Picture

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①Right Door

②⑥ Fan

⑧BF-FDO Lyse Inlet

③Upper Cover

④Back Cover

⑨BF-FDT Lyse Inlet

⑤Left Door

⑩BF-PK Diluent Inlet

⑦BF-SLS-I Lyse Inlet

Waste Solution Inlet

Figure 1-4-2 Rear Picture

1.4.3 Right Picture

①Net Port(LAN)

②Sensor Port

③Power Supply ④ Power Switch Figure 1-4-3

1.5 External Devices Printer：Connect with computer. The report can be printed through computer. 14

BF-6500 Automatic Hematology Analyzer User Manual Barcode Scanner：Connect with host computer to input barcode information. Note：The Printer is optional.

1.6 Symbol The following symbols include the symbols on the analyzer, reagent, Control and Calibrator. Symbol

Meaning The prompts to pay attention, otherwise, may result in personal injury. To perform as the instruction under the symbol, emphasize the important information and special contents. To perform as the instruction under the mark, or it may cause biological infection Laser Warning

AC symbol Only in vitro diagnostic use Storage temperature

Lot NO.

Validity

Serial number

Measurement control

Date of manufacture

Grounding

Manufacturer

Instrument conform to the in vitro diagnosis device directive of EU

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BF-6500 Automatic Hematology Analyzer User Manual Access to supplied file

Chapter 2 Installation To ensure the normal working of the instrument after installation，the initial installation and setup of BF-6500 Automatic Hematology Analyzer should be carried out by authorized personnel of Dirui. Note: Dedicated computer software should be used for controlling. It is recommended that the software and database is not installed in system disk.

2.1 Installation Requirement The space, power, environment should meet the requirement prior to instrument installation. The instrument should be placed on level operating table.

2.1.1 Space Requirement Ensure enough space for instrument maintenance.

● The space between the wall and the right & left side of the instrument ≥50cm ● The space between the wall and the back side of the instrument≥50cm 16

BF-6500 Automatic Hematology Analyzer User Manual ● The space between the front of the analyzer and other equipment ≥ 100cm; ● Ensure enough space under and above the instrument for diluent, reagent and waste solution collecting devices.

2.1.2 Power Requirement ● Power : ~220V 50Hz ● Analyzer Rated Power :175VA ● Fuse : 250V 4A； ● Large load equipment like air conditioner, refrigerator, oven etc. should not be inserted in the same outlet. A good grounding is must.

2.1.3 Environmental Requirement ● Working Temperature：15℃-30℃； ● Relative Humidity：≤75％; ● Atmospheric Pressure：75kPa-106kPa； ● The instrument should be protected from dust, mechanical vibration, significant noise and power interference. ● It is recommended that the electromagnetic environment assessment of the laboratory should be conducted prior to test. ● Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the proper working. ● It should be placed far from the constant ON-OFF electrical devices like brush-type motor, fluorescent lamp. ● It should be placed far from heat and wind source, sunlight, brush-type motor, flickering fluorescent light and electrical contact equipment. ● A well-ventilated place is a must. Note: The result will be unreliable if the room temperature or power can not meet the requirement. Or cause instrument damage and endanger personal safety.

2.2 Unpacking 2.2.1 Unpacking Step ● Check the packaging of the instrument. Contact Dirui or local distributor for any physical 17

BF-6500 Automatic Hematology Analyzer User Manual damage. ● Place the package in the direction of the arrow upward. ● Open the accessory box, mainframe box, check the items according to the packing list. Contact Dirui or local distributor for any shortage.

2.2.2 Remove Method ● Long-distance remove, after"clean pipe "and "empty pipe "(refer to 8.4.3.1) ● Cart can be used for short distance removal. ●The sampling probe should be protected carefully in removing and transportation. ● Keep the instrument upright in removing and transportation. ● Vibration should be avoided in removing and transportation. It should be used after checking and debugging.

2.3 Installation Steps The instrument should not be disassembled except normal maintenance.

2.3.1 Connecting

Figure 2-3-1 Analyzer and Reagent Connection (a) Lyse, Diluent, Waste Solution Connecting Put the BF-FDT lyse、BF-FDO lyse、SLS-I lyse bottle at the back of the instrument. Connect according to figure 2-3-1. Diluent container should be put under the working table. Connect according to figure 2-3-1.

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BF-6500 Automatic Hematology Analyzer User Manual (b) Liquid Level Sensor Connecting Connect one end to in figure 1-4-2. Put the other end into the waste barrel, reagent bottle and diluents according to the mark on the lead. Note ： Waste liquid should be disposed according to relevant local medical waste treatment regulations. (c)Computer Connecting Connect “Net Port” of computer host with “Net Port” of right side analyzer(figure 1-4-2 ) (d) Power Wire Connecting Connect one end of supplied power line with the attaching plug on the back side of the analyzer(③ of figure 1-4-2). And connect the power line of host, display and printer. Note: The socket connected with the power wire should be well-grounded. (e) Barcode Reader Connecting Insert one end of the bar code reader into the “USB” of the computer host. Note: The light beam of the barcode scanner may hurt eyes, therefore, staring should be avoided. (f)Printer Connecting Connect the printer and the computer host through data wire. （1）Whether the printer driver is installed. （2）Check the printing paper specification. Note: Tie wires will be used for fixing sampling probe before delivery. Wire 1 and 2 should be removed before power on, otherwise, probe may be damaged, as figure shows:

Wire1

Wire 2

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BF-6500 Automatic Hematology Analyzer User Manual Figure 2-3-2

2.3.2 Software Installation The software has been installed by DIRUI professionals before delivery. User should not uninstall it except abnormity occurs. In case of a must-uninstall, please follow the following steps: To start setup.exe after putting Hematology Analyzer Installation software CD in CD driver of computer, “NET Framework3.5” install assembly will pop up, as figure 2-3-3 shows:

Figure 2-3-3 Select “Accept” in above figure, SQL Server2005 Express Edition SP2 （ x86 ） will pop up, as figure 2-3-4 shows:

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Figure 2-3-4 Select “Accept” in above figure, as figure 2-3-5 shows:

Figure 2-3-5 Click “Install” in above figure, “NET Framework3.5” interface will pop up, as figure 2-3-6, 2-3-7 shows:

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Figure 2-3-6

Figure 2-3-7 When the above two installation have been finished, “SQL Server 2005 Express Edition SP2(x86)” will pop up, as figure 2-3-8 shows:

Figure 2-3-8 When the above installation has been finished, if other software is running, reboot the interface before the continuous running of popped installation program. As figure 2-3-9 shows:

Figure 2-3-9

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BF-6500 Automatic Hematology Analyzer User Manual Select “Install” in above figure, the installation interface will pop up after rebooting, as figure 2-310, 2-3-11 shows:

Figure 2-3-10

Figure 2-3-11 Click “Next” in above figure, select the installation path, the default path is C:\Program Files\BF6500\. As figure 2-3-12 shows:

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Figure 2-3-12 Click “Next” in above figure, the confirm interface will pop up, as figure 2-3-13 shows:

Figure 2-3-13 Click “Next” in above figure, “Installing BF6500 ” interface will pop up, as figure 2-3-14 shows.

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Figure 2-3-14 Click “Next” after installation has been finished, figure 2-3-15 will pop up:

Figure 2-3-15 Click “Close” in above figure to finish the installation of the software. The shortcut of the program will be displayed on the table after installation.

2.4 Software Uninstallation If the Automatic Hematology Analyzer application software need to be deleted from the current computer, click “Start” window, find “BF-6500” in “Program”, click “Uninstall BF-6500”, the 25

BF-6500 Automatic Hematology Analyzer User Manual confirm window will pop up, as figure 2-4-1 shows:

Figure 2-4-1 Click “OK” to finish the uninstallation.

2.5 Software Login Note: Turn on the power switch of the analyzer, login the application software.

2.5.1 Login Software

Double click the application software

, or click “Start”, find the software in “Program”

window, enter into “System Login” window, as figure 2-5-1, 2-5-2 shows:

Figure 2-5-1

26


Figure 2-5-2 Input username, password, the initial user name is Admin(can not be modified), the initial password is 1). If the input username or password is wrong, the screen will display login error, as figure 2-5-3 shows:

Figure 2-5-3 The program will exit automatically if the username or password error occurs for continuous 3 times. Input username, password in figure 2-5-2, click “Login”. Liquid pipeline, temperature and pressure self-test will be conducted by the instrument(the screen will display “System selftesting…..”). Main window will be displayed after self-testing. As figure 2-5-4 shows:

Main Menu

Status

Shotcut

27


Figure 2-5-4

2.5.2 Counting Interface 2.5.2.1 Main Menu Test：For sample information input, sample test mode selection, test records query. QC： L-J/Xbar and X-B QC. Calibration：Conducting calibration upon the analyzer. Setting：Set the analyzer parameters. Service：Test the status, maintain and detect the analyzer. Log：Keep the operation records.

2.5.2.2 Status Indication Area From left to right: network connection status, LIS system connection status, printing status:

（a） Network Connection Status：：Indicates the network is connected, operations are accessable.

：Indicates the network is disconnected.

（b） LIS System Connection Status：：Indicates LIS is connected，communication operation is accessable.

28


：Indicates LIS is disconnected.

：Indicates LIS is transmitting.

（c） Printer Status：：Indicates the printer is connected, printing is accessable. ：Printer is disconnected. ：Printer is working.

2.5.2.3 Public Information Area Bottom of the counting interface is the public information area, as figure 2-5-5 shows:

Usernam e

X-B Status

Failure Info.

Sample No.

Sample Info.

Info. Area

Running Status

System Time

Figure 2-5-5 （a）Failure Information Area: The corresponding failure information will be displayed in this area when failure occurs. Click this area, the failure dialog box will pop up, as figure 2-5-6 shows:

29


Figure 2-5-6 Click the corresponding information, the detailed solution will be displayed in “Detail Information” （b）X-B QC Switch Status： Use icon to indicate the switch status of X-B QC. With X-B is ON, without X-B is OFF. (c) Sample Status: Display the analysis mode and test mode. Analysis Mode: There are two modes. Whole blood mode and pre-diluted(peripheral blood). Test Mode: There are two mdoes.【CBC】and【CBC+DIFF】. （d）Test Status: Indicates the test status.

2.5.3 Log Off Click

in figure 2-5-4, as figure 2-5-2 shows:

2.5.4 Log Out

Click


Figure 2-5-7 30

BF-6500 Automatic Hematology Analyzer User Manual Click OK in above figure to exit. Click Cancel to return to interface. Note: Log off is recommended when the user is at rest. For avoiding non-user damage software or modify the data. Periodical database backup is recommended to avoid data lose caused by unforeseen circumstances. Input the initial user name and password in the first login. Set the user name, permission and password in "User Setting" after login for next login.

Chapter 3 Instrument Setting The system parameter of the instrument has been set before delivery. The interface of the first power on is system default. In order to meet the different needs of practical application, two

31

BF-6500 Automatic Hematology Analyzer User Manual permissions are provided(user permission and administrator permission), the user can reset some parameters.

3.1 Sample Information

Click


Figure 3-1-1 Analysis Mode: There are two modes. Whole Blood mode and predilute(peripheral blood) mode. Test Mode: There are two modes.【CBC】conduct counting without diff upon WBC, counting result includes histogram and its parameter of WBC, RBC and PLT.【CBC+DIFF】conduct counting and differential upon WBC, includes 24 parameters and scattergram, histogram. Sample No.: The sample No. input in this box is the next tested sample. Note: Sample No. with “-” is accessible. “.” is NOT accessible(“Sample No. Error” will be prompted if there is “.”). Reference Range: Click the drop down list of “Reference”, general, man, woman, child, infant and user-defined can be seleted.

32


3.2 Sample Registration

Click

of main interface shortcut in figure 2-5-4, “Sample/Patient Information” will pop

up, as figure 3-2-1 shows:

Figure 3-2-1

3.2.1 Edit Patient Information Click “Setting”in figure 3-2-1to set the input items of patient information, displays as figure 3-2-2:

Figure 3-2-2 33


 Default Value：This value is default when editing other sample information.  Remember： If

, the last edited sample information will be remembered when editting

other information.

 Ignore：If

, this item will be skipped during patient information input.

Click “OK” when “Default Value”, “Remember” and “Ignore” have been set. The mouse will move to the input box of sample No. in figure 3-2-1 to edit patient information.

3.2.1.1 Sample Information （a）Sample No.：Set the next sample No. manually. （b）Barcode No.：Can be input manually or by scanning. （c）Reference：Double click the input box behind “Reference” in figure 3-2-1,the following box will pop up:

Figure 3-2-3 Input the corresponding memoni in the input box of “System Code Selection”, or click the line of corresponding item(“Setting” of main menu→ “Information” to set the commonly used ID).Click “OK”.The reference range of test items includes general, man, woman, child, newborn and 5 user define. （ d ） Sampling Time, deliver time: Select “Current Time” or “ Empty” in the drop-down list of “Sampling Time”, “Deliver Time” in figure 3-2-1. If “Current Time” is selected, click the corresponding time, manual input is also available.

34


3.2.1.2 Patient Information (a) Case No.: Input the case No. in figure 3-2-1. (b) Name：Input the patient name directly. (c) Sex: Double click the input box behind “Reference” in figure 3-2-1, the following box will pop up:

Figure 3-2-4 Input the corresponding memoni in the input box of “System Code Selection”, or click the line of corresponding item(“Setting” of main menu→ “Information” to set the commonly used ID).Click “OK”. （d）Age：Input the patient age and double click the input box of age unit, the following box will pop up.

Input

the

corresponding

memoni in the input box of “System Code Selection”, or click

the

line

of

corresponding item(“Setting” of main menu→ “Information” to set the commonly used ID).Click Figure 3-2-5 “OK”. Note: There should be no “.” in age. (e) Department：Input the department name in department box, double click “Department” input box, the following box will pop up: 35


Figure 3-2-6 Input the corresponding memoni in the input box of “System Code Selection”, or click the line of corresponding item(“Setting” of main menu→ “Information” to set the commonly used ID).Click “OK”. （f）Bed No.：Click the input box of “Bed No.”in figure 3-2-1or input it directly. （g）Deliver：Input it directly or double click the input box of “Deliver”, the following figure will pop up:

Figure 3-2-7 Input the corresponding memoni in the input box of “System Code Selection”, or click the line of corresponding item(“Setting” of main menu→ “Information” to set the commonly used ID).Click “OK”. （h）Remark：the remark information after test can be input(can be input directly). Press enter to save the information when all the information have been finished.

36


Copy Patient Information In batch patient information input, input one patient information first and then copy it, modify part of the information at last. In figure 3-2-1, select the number of the information need to be copied, the selected line will turn into blue, click “Copy”, as figure 3-2-8 shows:

Figure 3-2-8 Input the copy number in the input box behind “Copy”, and click “OK”, the selected information will be copied.

Modify Patient Information The copied information need to be modified. In figure 3-2-1, select the number of the information need to be modified, the selected line will turn into blue. The selected patient information will be displayed on the left of the screen, which can be modified. Press “Enter” for saving after modification(refer to 3.2.1 for operation).

Delete Patient Information In figure 3-2-1, click the number of the information need to be deleted, click “Delete”, the drop-

down menu

will pop up, select the item need to be deleted, as figure 3-2-9

shows, click “OK” to finish the deletion.

37


Figure 3-2-9

Mask In figure 3-2-1, select the number of the information need to be masked, the selected line will

turn into blue(

in front of the number will be selected). Click “Mask”, the “Mask Status” will be

“Masked”. Click “Cancel Mask” to switch it into “Unmasked”. Note: The masked sample number(this record) will not be tested during test.

Query Click “Query” in figure 3-2-1, as figure 3-2-10 shows:

Figure 3-2-10 Sample information can be queried according to “Sample No.” “Case No.” and “Name”.

3.3 Setting 3.3.1 Normal User Click ”Setting” in main menu, as shown in figure 3-3-1： 38


Figure 3-3-1

3.3.1.1 Date Format Setting There are three date formats： YYYY-MM-DD 、 MM-DD-YYYY 、 DD-MM-YYYY ， select one of them and press”Apply”, the following information will be displayed：

Figure 3-3-2 Press “OK” to save the changed date format. Press “Exit” to exit the interface. Note： The changed date will be displayed in all positions with time(such as delivery time, sampling time, etc.).

3.3.1.2 Language Setting Click “Language Settings” in figure 3-3-1, as figure 3-3-3 shows:

39


Figure 3-3-3 Click the drop-down menu behind “Select Language”, select the language, click “Apply”, the tip “Save Success” will pop up, click “OK” to finish the language setting. As figure 3-3-4 shows:

Figure 3-3-4 Chinese and English are for selection.

3.3.1.3 User Setting Click “User Settings” in figure 3-3-3, as figure 3-3-5 shows:

40


Figure 3-3-5 Only the password can be modified when the user login as common user. Click “Modify Password” in figure 3-3-5, as figure 3-3-6 shows:

Figure 3-3-6 Input the new password and old password(the two passwords must be same), click “OK” to finish the modification. Note: User edition, addition and deletion can not be conducted when the user login as common user.

3.3.1.4 Reagent Validity Setting Single click “Reagent Validity Setting” in figure 3-3-5, as figure 3-3-7 shows:

41


Figure 3-3-7 Click the drop down box of corresponding item, select the validity according to the reagent instruction, press “Apply”, the tip “Save Success” will pop up, click “OK” to finish the setting. Click “Exit” to exit the interface. Note: The validity should be set again in the first time analyzer using or after reagent, diluent replacement. Expired reagent, diluent can not be used.

3.3.1.5 QC Setting Click “QC Setting” in figure 3-3-7, as figure 3-3-8, 3-3-9 shows:

42


Figure 3-3-9 Control method, calculation method and range of L-J/X-bar QC can be selected in figure 3-3-8. ON/OFF and sample No./group of X-B QC can be set in figure 3-3-9.

3.3.1.6 Print Setting Click “Print Setting” in figure 3-3-9. Printer name, pageheader icon, title and format of sample and QC can be set in figure 3-3-10.

Figure 3-3-10 （ a ） Printer ： Select the printer in its drop-down list. （ b ） Report Default

Icon:

Report pageheader icon can be set. Click “Select Picture”, the dialog box of picture path will pop up. Select the 43

BF-6500 Automatic Hematology Analyzer User Manual picture(picture size is 34*34, format can be BMP and JPG). Click “Clear Picture” to clear the pageheader icon. The icon will not be displayed in report preview. （c）Sample：Headline, pagefooter and print report format can be input in this unit.

 Headline ： Delete the original headline and input new headline if headline need to be changed.

 Page Footer：The page footer is user-defined, e.g. “This report is only responsible for the delivered sample.”

 Print Report Format: Select the format in its drop-down list. Click “Preview” to preview the format.

（d） QC：The headline and print report format can be input in this unit.  Headline：Delete the original headline and input new headline to change it.  Print Report Format：Select the print format in its drop-down menu, and click ”Preview” to preview the format. （e）Wintable：User can design report format. Refer to “Appendix B” for its using.

3.3.2 Administrator User Input administrator username and password when login(figure2-5-2), click “Setting”, as figure 33-11 shows, the administrator can set the following items besides common user’s : Note: Admin is system default administrator username. Default password is 1. The password can be modified, but can not be deleted.

44


Figure 3-3-11

3.3.2.1 User Settings Click “User Setting” in figure 3-3-11, as figure 3-3-12 shows:

Figure 3-3-12

· Add User： Click “Add” in figure 3-3-12, as figure 3-3-13 shows:

45


Figure 3-3-13 Input the username need to be added in the input box behind “Username”. Click to , which is in front of “Audit Permission” if the user needs audit permission, and click “OK” to finish the user adding. Click “OK” after username input if this user does not need audit permission. Note: The initial password of the new user is “1”, which can be modified after login. The name of new user can not be empty or same as other username.

·Delete User： Click the line of common user in figure 3-3-12, the selected line will turn into blue, the interface is like 3-3-14:

Figure 3-3-14 Click ”Delete” in above figure, the following prompt will pop up:

46


Figure 3-3-15 Click “Yes”, the selected user will be deleted.

·Edit User： Click the line of common user in figure 3-3-14, click “Edit”, the interface is like 3-3-16:

Figure 3-3-16 The audit permission of common user can be edited again. Select the radio in front of “Audit Permission” to give the permission to the user. Cancel it to cancel the permission.

· Modify Password： The password of the administrator and common user can be modified by administrator. Click the line needs to be modified in figure 3-3-14, click “Modify Password”, the interface is like 3-3-17:

Figure 3-3-17 Input old password, new password, press “OK” to finish the operation.

47


3.3.2.2 Net Setting Click “Net Setting” in figure 3-3-14, and select “Local Setting” in the displaylink, as figure 3-3-18 shows: （a）Local Setting:

Figure 3-3-18 The IP address and subnet mask, etc. of the computer will be displayed. （b）Device Setting： Select “Device Setting” in figure 3-3-18, as figure 3-3-19 shows:

Figure 3-3-19 48


The IP of hematology analyzer can not be modified by the user. （c）LIS Setting： Select “LIS Setting” in figure 3-3-19, as figure 3-3-20 shows:

Figure 3-3-20 IP and port of LIS computer can be set. ON/OFF status of auto-communication can be selected.

3.3.2.2 Unit Setting Click“Unit Setting” in figure 3-3-20, as figure 3-3-21 shows:

Figure 3-3-21 49

BF-6500 Automatic Hematology Analyzer User Manual Single click the input box behind items and select the units. Click “Apply” after input. Click “OK” when “Save Success” is prompted. Click “Default Value” to restore the setting when the unit has been modified accidentally.”Default value setting succeed” indicates successful setting. The units are as follow: Parameter WBC

Unit 109/L

***.**

3

10 /uL

***.**

2

10 /uL

****.*

/nL

***.**

LYM#、MON#、BAS#、EOS#、NEU 109/L # % LYM%、MON%、BAS%、EOS % 、NEU% RBC

HGB

MCV、RDW-SD

Default Unit

***.**

Default Unit

**.*

Default Unit

10 /L

**.**

Default Unit

6

10 /uL

**.**

104/ uL

****

/pL

**.**

g/L

***

g/dL

**.*

mmol/L

**.*

fL

***.* 3

Default Unit

Default Unit

***.*

pg

**.*

fmol

***

g/L

***

g/dL

***.*

mmol/L

***.*

RDW-CV

%

**.*

HCT

%

**.*

MCHC

Remark

12

um MCH

Value Form

L/L

Default Unit Default Unit

Default Unit

*.***

Default Unit

9

10 /L

****

Default Unit

103/uL

****

4

10 /uL

***.*

/nL

****

fL

**.*

um3

***.*

PDW

fL

**.*

Default Unit

PCT

%

.***

Default Unit

mL/L

*.**

%

**.*

PLT

MPV

P-LCR

Table 3-1

50

Default Unit

Default Unit


Note: The result form changes as the unit changes.

3.3.2.3 Reference Value Setting Reference range of general, man, woman, child, newborn and 5 user-defined are for selection, which is default as “General”. Single click “Reference Setting” in figure 3-3-21, as figure 3-3-22 shows:

Figure 3-3-22 Upper, lower Limit of Reference Input: Click the inputbox of upper and lower limit to input the values. Click “Apply” after input. Click “OK” after the prompting of “Saving succeed” to finish the saving. The following box will pop up if the input lower limit is greater than the upper limit, or the input reference is not within the set range.

Figure 3-3-23

51

BF-6500 Automatic Hematology Analyzer User Manual Input again after checking if the above box is prompted. Click “Default Value” to restore the setting when the reference has been modified accidentally. “Default value setting succeed” indicates successful setting.

Figure 3-3-24

3.3.2.4 Log Setting Click“Log Setting” in figure 3-3-22, as figure 3-3-25 shows:

Figure 3-3-25 The saving path of “Operation Log” and “Error Log” can be set. Note: The old records will be covered if the records reach the maximum saving number. Records can be saved for 1 year at most.

3.3.2.5 Information Setting （a）Department Information Setting： Click “Information” in figure 3-3-25, and select “Department Information” in the drop-down list of “Information Type”, as figure 3-3-26 shows: 52


Figure 3-3-26

· Add Department Information：Input the department name in the input box behind name. Input the commonly used memoni in the input box behind ID, click “Add”.

·Delete Department Information ： Select the items need to be deleted in the department information list, click “Delete”. （b）Doctor Information Setting: Select the “Doctor Information” in the drop-down list of “Information Type”, as figure 3-3-27 shows:

Figure 3-3-27

53


· Add Doctor Information ： Input the doctor name in the input box behind name. Input the commonly used memoni in the input box behind ID, click “Add”.

· Delete Doctor Information：Select the items need to be deleted in the doctor information list, click “Delete”. （c）Reference Selection: Select the “Reference” in the drop down list of “Information Type”, as figure 3-3-28 shows:

Figure 3-3-28 Select “General”, “Man”,”Woman”,”Child”,”Newborn”,”User Define 1”, ”User Define 1”, ”User Define 2”,”User Define 3”,”User Define 4” and ”User Define 5” in reference list. Only the commonly used ID of reference can be modified here, but not the name or add other reference. （d）Sex Selection： Select “Sex” in the drop down list of “Information Type”, as figure 3-3-29 shows:

54


Figure 3-3-29 Select “Male” or “ Female” in the sex list.Only the commonly used sex ID can be changed here. （e）Age Unit Selection： Select the “Age” in the drop down list of “Information Type”, as figure 3-3-30 shows:

Figure 3-3-30 Select “Years Old”, “Month”, “Day” or “Hour” in the list of age unit. Only the commonly used age unit ID can be changed here.

3.3.2.6 Backup Setting

55

BF-6500 Automatic Hematology Analyzer User Manual Select “Backup Setting” in figure 3-3-30, as figure 3-3-31 shows:

Figure 3-3-31

（a） Backup： Periodical database backup can prevent data lose. Single click “Backup” to backup the document into the folder. The default saving path is “backup”of software installation. The folder name is the current date+time+*.bak. Click “Apply” for saving.

（b） Data Recovery： The backup data can be used to recover the previous data if software can not be used for some reason. Select the saving path of backup folder before recovery. And select the document according to the backup date and time.

3.3.2.7 Abnormal Mark Setting Click “Abnormal Marker Setting” in figure 3-3-31, select “WBC”, as figure 3-3-32 shows:

56


Figure 3-3-32 Select “RBC/PLT”, as figure 3-3-33 shows:

Figure 3-3-33 The prompt range of WBC, RBC/PLT abnormal alarm information can be set in this interface. Click “Apply” for saving after input, click “Default Value” to recover, click “Exit” to cancel the interface.

57


Chapter 4 Normal Operation This chapter describes the whole process of daily operation from start to shut down. Focusing on the operation process of whole blood sample and pre-dilution (Peripheral Blood) sample testing. As shown in figure 4-1： Preparation before Operation

Power On

Daily QC

Sample Preparation

Sample Analysis

Shutdown

Figure 4-1

4.1 Preparation before Operation Check the instrument before using according to the following requirement. 1. Check the waste barrel To ensure daily empty before use. 2. Check pipeline Check the pipeline connected with reagent, waste liquid, and also the grounding. 3. Check the power supply Check the connection between power plug and power socket of the instrument, and the computer. 4. Check the printer Check the connection between the computer and printer. Check the printing paper and its installation. 58

BF-6500 Automatic Hematology Analyzer User Manual 5. Check the barcode reader Check the connection between the computer and the barcode reader.

4.2 Daily QC Note: QC analysis should be conducted everyday before sample analyzing to ensure reliable result. Refer to chapter 6 for operation.

4.3 Sample Preparation 4.3.1 Whole Blood Sample Preparation: 1 ． Use clean EDTA-K2 (1.5—2.2mg ／ mL blood)anti freezing vacuum tube to collect venous blood sample for more than 500ul. 2．Mix the venous blood with anticoagulant promptly. Note：

 Use clean EDTA-K2 anti freezing vacuum blood collecting tube, silicified glass/plastic tube and 20uL silica glass capillary.

 The sample that needs WBC differential or platelet counting should be stored at room temperature. It should be used within 8 hour after collection.

 If 5 part of PLT, MCV, or WBC is not needed, the sample can be stored at 2 ℃ - 8 ℃ in refrigerator for 24 hours. The stored sample should be used after placing at room temperature for at least 30 minutes. 

After a period of time of still placing, the sample should be mixed again before use.

4.3.2 Preparation Method of Pre-dilution Sample (Peripheral Blood)

· Click

in shotcut area, the screen display as figure 4-3-1, 4-3-2 shows:

59


Figure 4-3-1

Figure 4-3-2

·Take a clean tube or centrifuge tube, place it under the sample probe, as figure 4-3-3 shows:

Figure 4-3-3 Press aspiration key, the diluent will be dispensed into the tube, the screen displays as figure 43-4 shows:

Figure 4-3-4 60

BF-6500 Automatic Hematology Analyzer User Manual Ensure all the diluent(180uL)is added into the tube. Move the tube after the buzzer sound has been heard.

· And put 20 uL peripheral blood into the tube follow the tube wall. Mix them. · Click “Cancel” in figure 4-3-2, as figure 4-3-5 shows:

Figure 4-3-5 Cancel diluent adding to finish one preparation of diluted sample.

· If there are some sample need to be diluted after the first one, the interface will be as figure 43-2, repeat the first process to finish other sample dilution. About 20 sample dilution can be done continuously. Note： ●The operator can also use pipette to aspirate 180uL diluent and dispense it into the tube follow the tube wall. And add 20 uL peripheral blood into the tube follow the tube wall. Mix them. ● When “pre-dilute” is selected, “Attention! Dilute sample in ratio of 1:10” will be prompted in sample information. ●The diluent should be prepared in advance and protected from dust. ●After the mixing of peripheral blood and diluent, it should be placed for 3 minutes, and then remix before use. ●The diluted sample should be used within 30 minutes. ● The sample should be re-mixed after placing for a period of time before use. ●The stability of the result on pre-dilution mode should be evaluated according to their own sample number, sample collection method and technical level.

61


4.4 Sample Testing of Whole Blood Mode 4.4.1 Changing Test Mode and Sample No. In main interface, if the current mode is “Whole Blood”, testing can be carried out directly. Or switch the current mode to “Whole Blood”. Note: The pipeline should be rinsed when “Predilution” is switched into “Whole Blood”. （a）In main interface, press the

. As shown in figure 4-4-1:

Figure 4-4-1 （b） In “Mode”, blood sample mode is whole blood or predilution. （c）The testing mode is “CBC”or“CBC+DIFF”. “CBC”mode：conduct counting without WBC differential. The result include 14 parameters and RBC, PLT histogram. “CBC+DIFF”mode ： conduct counting and WBC differential. The result include 24 parameters, scattergram, histogram and 10 research parameters. (d) Input the next sample No. in “Sample No.” input box. (e) Select the reference range in the drop down list of “Reference Range”, default as “General”. Note： The maximum digit of sample No. is 15. All number should not be “0”, otherwise, the software prompts invalid input. 62

BF-6500 Automatic Hematology Analyzer User Manual Number to enter "-", but not enter "."

4.4.2 Sample Information Editing Note： Edit the waiting sample before analysis. Click

in main interface. As shown in figure 4-4-2:

Figure 4-4-2

4.4.2.1 Information Editing of Single Patient Sample Information：refer to 3.2.1.1； Patient Information：refer to 3.2.1.2；

4.4.2.2 Batch Patient Information Input In batch patient information input, input one patient information first and then copy the input patient information, modify part of the information at last. Operations are same as the "3.2.2 Copy Patient Information" "and" 3.2.1 Edit Patient Information "

4.4.3 Sample Testing Steps Note： ● There should be a space between probe tip and test tube bottom in the process of sample 63

BF-6500 Automatic Hematology Analyzer User Manual aspiration, otherwise, the accuracy of the aspiration volume may be affected. ● Set the reference range of parameters in “Setting” interface, otherwise, incorrect alarm will be prompted after testing. ● The default reference range is “Normal”. The alarm prompted after test is according to the reference range of “Normal”. Whole Blood Sample Testing Conduct whole blood sample testing according to the following steps in “Counting Interface”(As shown in figure 4-4-3):

Figure 4-4-3 （a）Check the working mode is “Whole Blood Mode”, the green indicator in the middle of the front upper cover is bright. （b）Place the sample under the sampling probe. Make sure the probe can aspirate the mixed sample. （ c ） Press “Counting” on instrument panel to start the sample testing. The sampling probe aspirate 20uL sample. （ d ） When the buzzer is heard, the operator can remove the sample. The sampling probe injects the sample into the counting pool. The instrument will carry out test automatically. （e）The sampling probe reset after testing, and prepare for next testing. The test result will be displayed in the chart review of the computer. Meanwhile, the next sample number will plus one automatically.

64

BF-6500 Automatic Hematology Analyzer User Manual （f）The instrument will save the test result after test. （g）Conduct other sample testing according to this process. （ h ） Click

to enter into query interface, press “Print” or “Batch Print” to print the

report.

Note：

 In the process of testing, the interface can be switched to “Picture” “Research Parameter” to browse the pictures or check the study parameters. But no operation can be conducted. The data will be saved into the data review after test automatically.

 If block or air bubbles occurred, the instrument will set the relative parameter to be invalid. And prompt the failure on the screen. 

The result will be inaccurate if the temperature exceeds the normal working temperature range of the instrument.

4.4.4 Picture Check Click “Picture” in figure 4-4-3 to check the pictures of the test results, as figure 4-4-4 shows:

Figure 4-4-4 Histogram of RBC, PLT and WBC; histogram and scattergram of WBC 4 diff will be displayed.

65


4.4.5 Research Parameter Check Click “Research Parameter” in figure 4-4-4 to check 10 research parameters, as figure 4-4-5 shows:

Figure 4-4-5

4.5 Pre-dilution Sample Testing Check the working mode is “Predilution Mode” in “Counting” interface(as figure 4-4-3 shows), otherwise, switch the current mode to “Predilution”mode. Note: The pipeline will be rinsed after mode switching. （a）When the green indicator in the middle of the front upper cover is bright, place the diluted sample under the sampling probe. Make sure the probe can aspirate the mixed sample. （ b ） Press “counting” on instrument panel to start the sample testing. The sampling probe aspirate 80uL. （ c ） When the buzzer is heard, the operator can remove the sample. The sampling probe injects the sample into the counting pool. The instrument will carry out testing automatically. （d）The sampling probe reset after testing ，and prepare for next test. The test result will be displayed in the pictures review of the screen. Meanwhile, the next sample number will plus one 66

BF-6500 Automatic Hematology Analyzer User Manual automatically. （e）The instrument will save the test result after test. （f）Conduct other sample test according to this process. （ h ） Click

to enter into query interface, press “Print” or “Batch Print” to print the

report. Note：

 In the process of testing, the interfaces can be reviewed. But no operation can be conducted. The data will be saved into the data review after test automatically.

 If block or air bubbles occurred, the instrument will set the relative parameter to be invalid. And prompt the failure on the screen. 

The result will be inaccurate if the temperature exceeds the normal working temperature range of the instrument.

4.5.1 Parameter Alarm Parameter alarm include the following three situations: If the result is marked with “H”or“L”, that means the result exceeds the reference range. If the result displayed as “***” ， invalid result or range exceeding can be indicated. If WBC counting result is smaller than 0．5*109／L or bigger than 999*109／L，or the pre-dilution result is smaller than 2*109／L or bigger than 999*109／L, the system will not conduct WBC differential, the relevant parameter displays as “***”. If the result is displayed with “?”, then the result is unreliable.

4.5.2 Differential or Abnormal Form Alarm The instrument can prompt alarm according to the histogram and scattergram. As shown in table 4-1: （a）WBC abnormity alarm information Information Meaning WBC scattergram abnor WBC scattergram abnormal mal ? WBC increase Higher WBC counting WBC reduction Lower WBC counting Neutrophil increase Higher neutrophil counting Neutrophil reduction Lower neutrophil counting Lymphocyte increase Higher lymphocyte counting Lymphocyte reduction Lower lymphocyte counting 67

Judging Standard DIFF channel scattergram abnormal WBC>18.0*10^9/L WBC<2.5*10^9/L NEUT#>11.0*10^9/L NEUT#<1.0*10^9/L LYM#>4.0*10^9/L LYM#<0.8*10^9/L

BF-6500 Automatic Hematology Analyzer User Manual Monocyte increase Eosinophil increase Basophil increase

Higher Monocyte counting Higher eosinophil counting Higher basophil counting

MON#>1.0*10^9/L EOS#>0.7*10^9/L BASO#>0.2*10^9/L

(b)WBC unreliable alarm information Left Shift ？ Left shift may be existing.

In shift left position of scattergram, more scatter dots exits. Immature Cell？ Immature cell exists. The proportion of immature cell is bigger than the set reference value. Abnormal Lymphocyte Lymphocyte abnormity exists. Abnormal lymph or non-typical lymph is bigger than the set reference value Nucleated red blood cell Maybe RBC hemolysis is not The scatter dots are condensed / platelet aggregation complete, red blood cell is on between lymphocyte and ghost cell. immature stage or platelet aggregation (c)RBC/HGB abnormal alarm information Information Meaning Abnormal RBC Abnormal RBC histogram distribution distribution RBC size is different. RBC size is different. Small RBC Smaller MCV Big RBC Bigger MCV RBC increase RBC increase Anemia Anemia Low pigment Low pigment Bimodality RBC bimodality distribution

(d)RBC/HGB unreliable alarm information Information Meaning RBC or hemoglobin RBC or hemoglobin may be inaccurate. unreliable？ Hemoglobin Abnormal hemoglobin maybe abnormity/interference exists, or interference factor maybe exists. ？

Judging Standard Abnormal RBC histogram RDW-SD>65or RDW-CV>20 MCV<70fL MCV>110fL RBC>6.5*1012/L HGB<100g/L MCHC<290g/L RBC histogram has two or more peaks. Judging Standard Compare the result of hemoglobin with RBC result Calculate and compare the special analytical parameters.

(e)PLT unreliable alarm information Information

Meaning

Judging Standard

PLT increase

PLT increase

PLT>600*109/L

PLT reduction

PLT reduction

PLT<60*109/L

PLT distribution abnormity

PLT histogram abnormity

distribution

PLT histogram abnormity

(f) PLT unreliable alarm information Information

Meaning

PLT aggregation？

PLT aggregation exists.

Judging Standard maybe

68

Calculate and compare the special analytical parameters.


Table 4-1

4.6 Sleeping The analyzer enters into sleeping status after stop for 30 minutes, and the status information will be displayed in failure area. Press liquid aspiration key to proceed with operation.

4.7 Rinse and Clog Removal The analyzer will conduct automatic rinsing(sample flow parts) in each counting process to ensure that no sample residue, rinse components are as follows:

 Internal and external wall of sampling probe；  Counting pool and quantitative tube；  Flow cell When the analyzer prompt “Aperture Clog”, click “Remove Clog” in “Service-Maintenance” interface(same as conducting “Zap” and “Backflush” aperture).

4.8 Shutdown Note： In order to ensure the stability and accurate test result of the instrument. Shutdown operation is required after 24 hours continuous working. The operator must follow these steps to shut down the instrument. Shutdown includes mainframe shutdown and exit software.

4.8.1 Shutdown Mainframe Click "

" in main interface. As shown in figure 4-8-1：

Figure 4-8-1

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Click “OK”, above figure will pop up. After shutdown liquid aspirating, “Shutdown the analyzer ” will pop up, the instrument will conduct pipe and counting pool rinsing and soaking.The following box will pop up after the previous two steps:

Figure 4-8-2 ·Switch to “O” on the right of the analyzer to finish shutdown.

·Empty the waste solution container after shutdown. Note: Click “Re-start” in figure 4-8-2 if more tests are needed.

4.8.2 Exit Software ·Click

，or select “Menu”→“Exit System”，the following box will pop up：

Figure 4-8-3 Click “OK” to exit the software to finish the whole shutdown process. 70


Chapter 5 Record Query The instrument will store the result into database automatically after each test. The maximum storage capacity 100000 (including 24 parameters, 10 research parameters, scattergram and histogram). The operator can query the sample result, scattergram and histogram of the database. The result will be covered if the storage number is more than 100000.

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Click

in main interface to enter into query interface, as figure 5-5-1 shows:

Figure 5-1-1 The result displayed in the base is in testing sequence(The last result is at the first place). The default mode is list mode. If the screen can not display all result, press ”Next” or “Previous” to switch the pages. The position of the current result and the total number of data base will be displayed in the form of “Pos/Total” at the bottom of the interface.

5.1 Record Selection If the sample with known position needs to be queried, click “Select” in figure 5-1-1, and select

“Condition” in its drop down list

, as figure 5-1-2 shows:

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Figure 5-1-2

· Input the “Start Record” and “End Record” need to be queried in figure 5-1-2, click “OK”. The sample will be selected with

.

Note: The input sample position should within the range of sample lib, otherwise, “Input range error, please input again” will be prompted.

·If “Cancel Selection” is selected in drop-down list, the selection will be canceled.

5.2 Print The sample results can be printed in sample query interface.

· Single sample Printing： Click “Print” in figure 5-1-1, if “Preview or not before printing” is selected in “Print Setting”, as the following figure shows:

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Figure 5-2-1 Click

in above figure to print the report.

·Bulk Print：Click “Bulk Print” in figure 5-1-1, as figure 5-2-2 shows:

Figure 5-2-2 Select the test date of the report, and input the start and end sample No. If “Audited” is selected and “Preview or not before printing” is selected, the report can be previewed, as the following figure shows:

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Figure 5-2-3 The selected & audited samples will be printed. If “Audited” is not selected, all selected samples will be printed.

5.3 Query The data can be queried through different condition. Click “Query” in figure 5-1-1, and select “Condition” in its drop-down list

, as shown in figure 5-3-1.

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Figure 5-3-1 Users can select different query conditions to query, including: sample No., barcode No., test time, test mode, case No., name, gender, department, deliver doctor, auditor and tester. The results can be queried according to one condition or multi-condition.

5.3.1 Query Accroding to Sample No. Input the sample No. in the box behind “Sample No.” need to be queried in figure 5-3-1, if the input sample No. is “14”, click “Query”, the sample results with No. “14” will be displayed, as figure 5-3-2 shows:

Figure 5-3-2

5.3.2 Query According to ID Number Input the ID No. in the box behind “Barcode” need to be queried in figure 5-3-1, click “Query”, the results will be displayed.

5.3.3 Query According to Test Mode and Date In figure 5-3-1, select the start date and end date of the samples need to be queried in the dropdown list behind test time, and select the corresponding “Test Mode” and “Analysis Mode”, click “Query”, the records will be displayed. 76


5.3.4 Query According to Case No. Input the Case No. in the box behind “Case No.” need to be queried in figure 5-3-1, click “Query”, the results will be displayed.

5.3.5 Query According to Name and Sex Input the name and select the sex of the patient in the box behind “Name” need to be queried in figure 5-3-1, click “Query”, the results will be displayed.

5.3.6 Query According to Department and Deliver Doctor Select the department of the sample in the drop-down list behind “Department”, and select the deliver doctor of the sample in the drop-down list behind “Deliver Doctor” need to be queried in figure 5-3-1, click “Query”, the results will be displayed.

5.3.7 Query According to Auditor Select the auditor of the sample in the drop-down list behind “Auditor” need to be queried in figure 5-3-1, click “Query”, the results will be displayed.

5.3.8 Query According to Checker Select the checker of the sample in the drop-down list behind “Checker” need to be queried in figure 5-3-1, click “Query”, the results will be displayed. Note: If “Perfect Match” is selected in above query, only perfect match results will be displayed. If “Perfect Match” is not selected in above query, all results that can meet the input condition will be displayed. Take sample No. as an example: If sample with No. 11, 211, 311 exist, when “Perfect Match”is selected, the input query No. is 11, only sample No.11 can be queried.11, 211, 311 will be displayed when “Perfect Match” is not selected.

5.4 CV Calculation Users can select records among 3-500 to calculate the CV, Mean and SD. If the selected records is less than 3, the interface will be: 77


Figure 5-4-1 Click the No. in front of record(√), and click CV, as figure 5-4-2 shows:

Figure 5-4-2 The repeatability of the results can be checked. If the any parameter of the selected sample is invalid, then the repeatability of this parameter is invalid. Click “Exit” in above figure to exit the interface.

5.5 Bulk Audit The user can conduct bulk audit in result query, click bulk audit in figure 5-1-1, as figure 5-5-1 shows:

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Figure 5-5-1 Select the test date in the drop down list of “Test Date”, and input the start sample No. and end sample No., click “OK”，the auditor information of audited sample result will be displayed behind auditor.

5.6 Communication

Click “LIS Comm.” in list

review interface to conduct data transmission with LIS

system.

Figure 5-6-1

5.7 Delete Click “Delete” in figure 5-1-1, and select the records need to be deleted in its drop-down list


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Figure 5-7-1 Click “OK” in above figure to delete the records.

5.8 Export The exported data can be saved. Click “Export” in figure 5-3-2, select the data needs to be exported in its drop-down list

, as the following figure shows:

Figure 5-8-1 Input the file name in the input box behind ”File Name”, and select the saving path, click “Save”, the following box will pop up:

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Figure 5-8-2 Indicates successful data export. Note: The exported file should be saved in EXCEL form.

5.9 Chart Query User can check single record in chart form, in figure 5-1-1, double click the sample result line, as figure 5-9-1 shows:

Figure 5-9-1 The sample result position and the total number in sample database will be displayed in the lower side of the interface in “Pos/No.” form. Current data can be saved, deleted or audited in this interface.

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Chapter 6 Quality Control

Error may occur after long-term using which may lead to unreliable result. Quality control (QC) provides an effective way to detect error. Only by familiar with the QC theory and practical operation method, the error impact can be excluded. In order to ensure the reliability of the result. The daily low, medium and high level control should be used to conduct instrument control. This instrument provides three QC method: L-J QC, X QC and X-B floating mean methods.

6.1 L-J QC Under “L-J” QC, the operator can carry out quality control of 24 parameters. The instrument provides 12 QC documents in order to save quality control parameter and result. Each quality control document can save up to 400 groups of quality control results. When the number of quality control is more than 400, the new QC result will cover the old result. Click “QC” of main interface and select “L-J/Xbar” in

1.

82

, as shown in figure 6-1-


6.1.1 Quality Control Setting 6.1.1.1 Lot No. Information Setting QC information can be set through setting button. Click set, as shown in figure 6-1-2.

Figure 6-1-2 (a) Select Document No. Click the drop down list of document No. to select the document needs QC, the range is 1~12. (b) QC Lot No. Input Input the corresponding Control lot No. in the drop-down list of “Lot No.” according to Control instruction. (c)Validity Setting: Click the drop down list of “Validity” to input the validity according to the instruction. (d)QC Level Selection： Select QC level (High, Mid, Low)in drop down menu of “Level”. Each lot No. corresponds to one level. Click “Save” when above input is completed. “Save Success” will pop up, and click “OK”. (e) Target Value, SD Input Input the target value and SD according to the QC instruction. Note： 83

BF-6500 Automatic Hematology Analyzer User Manual The input lot No., validity should be the validity marked on the instruction. QC mode can be modified in “Sample Information” of counting interface shortcut. For the Control is whole blood, “Pre-dilute” can not be selected in analysis mode. ”Test Mode” is “CBC+5DIFF”，if test mode is “CBC”，as shown “CBC mode can not count”when counting.

6.1.1.2 Preset Value The QC result in QC chart can be used to calculate Mean, SD and CV%. In QC edit, it can be used as preset value. (a)Deviation Limit Setting If the display form of deviation limit or calculation method of deviation limit in pre-set value need to be adjusted, following these steps: Click “Set” in main menu, select “QC Setting” in its left, as figure 6-1-3 shows:

Figure 6-1-3 Calculation method and range selection of deviation: When” Absolute Value” calculation method is selected, the input deviation limit will be displayed in the form of absolute value. “Range” will use two times the standard deviation (2SD) or 3 times the standard deviation (3SD) as the deviation limit; When“Percent”calculation method is selected, the input deviation limit will be displayed in the form of percent. “Range”will use 2 times the variation coefficient（2CV） or 3 times the variation coefficient（3CV）as the deviation limit. Click “Apply” in figure 6-3, the preset value is obtained according to the set method, and it is 84

BF-6500 Automatic Hematology Analyzer User Manual taken as the target value and deviation limit of current QC document. The corresponding position of the parameter will be displayed in figure 6-1-2. (b)If abnormal QC point occurs, preset value can be obtained after abnormal point deleting. The operating steps are as follow:

Figure 6-1-4 Click “OK” of above figure, the screen will be switched into QC interface, as figure 6-1-5 shows:

Figure 6-1-5

· If the second point on the left is abnormal point, click it, the red cursorline is on the second point, click “Delete”, the selected point will turn into “Blue”. Use the same method to delete the abnormal points. The blue point will not be counted during calculation.

· Click “Calculation” after the points are deleted, the screen will return to”Setting” interface, and the result will be displayed.

· If the valid QC point number is less than 3, click “Preset Value”, figure 6-1-6 will pop up:

85


Figure 6-1-6

·If the above operation is found to be wrong, click the deleted point, and click “Add”, the blue point will turn into red or green(normal point). Note: Valid QC points are taken as reference and deviation limit when taking preset value.

6.1.2 QC Counting Click QC count in figure 6-1-5 to enter QC counting interface, as shown in figure 6-1-7.

Figure 6-1-7 The specified Control of DIRUI should be used to avoid QC result error. See the instruction for the use of Control. The result will not be reliable when analyzer failure occurs.

● QC Counting Ensure the mode is “Whole Blood”.

86

BF-6500 Automatic Hematology Analyzer User Manual Place the mixed Control under the sampling probe. Press “Sample Aspiration” to start QC counting.The sampling probe will aspirate 20ul Control automatically to conduct QC counting.

Figure 6-1-8 The result will be displayed on the screen. If the result is lower than the lower limit of the software or higher than the display range, the following box will pop up:

Figure 6-1-9 Click “Cancel” in above figure, this result will be deleted.

● QC Data Query The stored QC result can be queried through button Next, Previous under Position/Total Number after QC counting.

6.1.3 QC Result Review Click QC Graph in figure 6-1-7 to enter review interface. As shown in figure 6-1-10:

87


Figure 6-1-10 (a) QC Graph Setting： Click Setting in “QC Graph” interface to set the parameters or move the display position, as figure 6-1-11 shows:

Figure 6-1-11

·QC Item Setting： Select the parameter name in figure 6-1-1, click “OK”, only the selected parameter will be saved.

·QC Item Moving： 88

BF-6500 Automatic Hematology Analyzer User Manual If the parameters need to be moved, select the parameter need to be adjusted(the selected line is blue), click “Move Up”, ”Move Down” to move the selected parameter.

(b)Explanation of QC result review interface： If QC counting number is less than 3, the right side of QC chart will not display the QC result. The abscissa indicates the QC counting number. The vertical axis indicates QC counting result. Vertical line marked for the same set of counting data. For each parameter, its QC chart can display up to 31 points. For each parameter, the three numbers on the left of the QC chart correspond to the three boundaries of QC chart. From top to bottom, they represent the upper limit, target value and lower limit. Upper limit：Control reference value + deviation limit Target value: Control reference value Lower limit：Control reference value - deviation limit For each parameter, the three number on the right of the QC chart represent Mean, SD and CV % respectively. (c)Point explanation of QC chart The points are QC results, they are connected by lines. “Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is not within the range. (d)If the point is not within the range, conduct the following steps. Check the target value and deviation limit. Check whether the background test is normal. Conduct QC again if the above two points are normal. If abnormity remains, conduct QC counting after calibration. Contact DIRUI’s after sales service department if abnormity remains after calibration. (e)QC chart printing： Click Print in figure 6-1-10, if “Preview before print” is selected in print setting, preview can be conducted before printing, as the following figure shows:

89


Figure 6-1-12 Connect the printer, click

to print the report.

6.1.4 QC List Different QC documents can be queried. Click “QC List” in figure 6-1-10, and select the QC document No. in the drop down menu of “Document No.” to enter the interface of figure 6-1-13

.

Figure 6-1-13 90

BF-6500 Automatic Hematology Analyzer User Manual (a) Delete All：The operator can delete all QC results of current QC document. Click “Delete All” in figure 6-1-13, as figure 6-1-14 shows:

Figure 6-1-14 Click “Yes”, the interface will display “Delete Succeed”, which indicates that all QC results are deleted. (b)Delete：The operator can delete some QC results of current QC document. Select the QC data need to be deleted in figure 6-1-13, click “Delete”, as figure 6-1-14 shows, click “Yes”, the interface displays “Deleting Succeed”, which indicates the selected QC results are deleted. (c)Print：The operator can print the QC counting result of current QC document. (d)Export：The operator can export the QC counting result of current QC document. (e)Communicate：The operator can transmit the QC counting result of current QC document to LIS.

6.2

X

QC

X QC：the mean value of two testing result will be one QC point in the QC chart. The operation is same as “6.1 L-J QC “.

6.3 X-B QC X-B floating average method is proposed by Dr. BrianBull. Through monitoring stability of red blood cell parameter, such as MCV, MCH, MCHC, etc. to monitor instrument performance. It belongs to the quality control without control. Together with the quality control with control, they all belong to instrument performance monitoring method which can reflect instrument performance from different aspects. They are not mutually replaceable. The X-B quality control is 91

BF-6500 Automatic Hematology Analyzer User Manual recommended when the daily sample is greater than 100 per day. This quality control method requires the use of random sample, therefore, the classified sample is not suitable. It offers the upper and lower limit to form a reference range. Observe the changing trend of result within the reference range. This instrument conduct X-B QC toward MCV、MCH、MCHC. The sample number in each group can be set as 20-200. The sample is come from normal counting result of the instrument, without classifying whole blood and pre-dilution mode. Calculation is needed before testing, because X-B reference value is obtained through analyzing a large number of random sample.

6.3.1 QC Setting The QC parameter need to be set before X-B QC analysis.

(a）Click “Setting” in main menu, and select “QC Setting” in the left menu, open ”X-B” interface, as figure 6-3-1 shows:

Figure 6-3-1 Sample No. selected for each X-B point can be 20-200, the recommanded number is 20. Click ON under “X-B QC ”, click “Apply”, “Saving succeed” will pop up, click “OK”.

（b） Click “QC” in above menu, and select “X-B” in

92



Figure 6-3-2 Target and Deviation Limit Input: Click the target and deviation limit to input them. Target：Reference of different area may be different, so the sample number should reach certain number(more than 500), the mean should be taken as target of X-B QC. Deviation Limit: 3%-5% of target should be taken as deviation limit. Note: Target and deviation limit can not be blank. (c)Click “Save” after setting, “Saving Succeed” will pop up, click “OK”.

6.3.2 QC Counting The operator can conduct X-B QC upon normal counting result. The system will conduct X-B QC calculation after 20-200 samples(Set according to the sample number/group ). Each X-B QC parameter will get a QC point. It will be stored in X-B QC chart and X-B QC list.

6.3.3 QC Graph Review Click “QC Graph” in figure 6-3-2 to enter into X-B QC graph review interface, as shown in figure 6-3-3.

93


Figure 6-3-3 (a)QC graph explanation: The abscissa is the counting result number. The vertical axis is the result. For each parameter, the three numbers on the left of the QC graph correspond to the three boundaries of QC graph. From top to bottom, they represent the upper limit, target value and lower limit. Upper limit：Control reference value + deviation limit Target : Control reference value Lower limit：Control reference value - deviation limit For each parameter, the three number on the right of the QC grapch represent Mean, SD, and CV% respectively. (b)Point of QC graph explanation The points are QC results, they are connected by lines. “Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is not within the range. (c)If the point is not within the range, conduct the following steps. Check the target value and deviation limit. Check whether the background test is normal. Contact DIRUI’s after sales service department if abnormity remains after calibration. (d)QC data checking The QC result can be checked through previous and next. Corresponding QC result 94

BF-6500 Automatic Hematology Analyzer User Manual will be displayed under the parameter name. The position of the QC point and the total QC result number will be displayed in the form of “Position/Total Number” at the lower left side of the interface.

6.3.4 QC List Review Click QC list in figure 6-3-3 to enter the X-B QC list review interface, as shown in figure 6-3-4.

Figure 6-3-4 (a)Delete：Click the QC data behind corresponding No., the line will turn blue, click “Delete”, as figure 6-3-5 shows:

Figure 6-3-5 Click “Yes” in above figure, “Delete Succeed” will be displayed, the selected records will be deleted. Note:

95

BF-6500 Automatic Hematology Analyzer User Manual Reference range and deviation limit can not be deleted. (b)Delete All：Click “Delete All”, as figure 6-3-6 shows:

Figure 6-3-6 Click “Yes” in above figure, “Delete Succeed” will be displayed, the all records will be deleted. (c）Export：Click “Export” to enter figure 6-3-7:

Figure 6-3-7 Input the document name in the input box behind “File Name”, and select the saving path, click “Save”. Note：The exported document will be saved in EXCEL form. (d ） LIS Transmission ： Click “LIS Transmission”, the data will be transmitted to LIS, as the following figure shows:

Figure 6-3-8 96


Chapter 7 Calibration Calibration of the instrument is to ensure the accuracy of the results. Calibration must be carried out before test.

7.1 Calibration Frequency The instrument calibration has been conducted in the factory. Calibration is still required in the following three cases: ● Before first use ● After main part replacing ● Obvious deviation exits in QC running

7.2 Calibration Method The instrument offers three calibration methods: manual calibration, calibrator calibration and fresh blood calibration. In automatic calibration and fresh blood calibration, the relative calibration will be conducted automatically by the instrument, and the calibration coefficient will be stored in “manual calibration” interface.

7.2.1 Preparation before Calibration Conduct the following checks before calibration. Contact Dirui's after-sales service department for any problem.

· Check the instrument and the reagent to ensure enough reagent to finish whole calibration process. If the reagent is finished in the process of calibration, calibration should be conducted again.

· Conduct background testing. If the blank test value exceeds the background range, solution should be seeked to ensure the result meet the requirement.

· The Control and reagent specified by Dirui company should be used. The corresponding operation should refer to the Control and reagent instruction.

7.3 Calibration with Calibrator 97

BF-6500 Automatic Hematology Analyzer User Manual Note: calibration with calibrator should be conducted under whole blood mode.

Click “Calibration” of above menu, and select “Calibrator Calibration” in

,

as figure 7-3-1 shows:

Figure 7-3-1 （a）Calibrator Reference Value Input： Click the corresponding line of “Reference”, input the value. （b）Calibration Counting： Put the prepared Calibrator under the sampling probe(No less than 0.5 mL) after reference value input. Press “Sample Aspiration”, the sampling probe will aspirate 20uL Calibrator and start calibration counting automatically.

Figure 7-3-2 After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient calculation and save the calibration coefficient result. Save after 5 times counting is 98

BF-6500 Automatic Hematology Analyzer User Manual recommended. As the increase of calibration times, CV and calibration coefficient will be updated. The following box will pop up if the results obtained beyond the scope.

Figure 7-3-3 Click “OK” to close the box and clear the result of this counting. The result will be displayed on the calibration interface only if the counting result is valid. When saving the counting result after obtaining 3 or more counting result, if the calibration coefficient of certain parameter is not within 75%-125%, click “Save”, the following box will pop up:

Figure 7-3-4 Operator should check the reference value input, if the reference value input is correct, operator delete calibration results, re-run the calibration count. （c）Calibration Result Deleting. If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating this result is not counted during CV, mean, calibration coefficient calculation. If this result deletion is not needed after test, click “Test Result” again(mark √ ), indicating this test result is valid. If this result is invalid, click “Delete” to delete the result.

99

BF-6500 Automatic Hematology Analyzer User Manual （d）Calibration coefficient saving： Click “Save” in figure 7-3-1 after 5 times counting, the following box will pop up.

Figure 7-3-5 Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of “Manual Calib” interface. As figure 7-3-6 shows:

Figure 7-3-6

7.4 Fresh Blood Calibration 7.4.1 Fresh Blood Preparation. Use EDTA-K2 (1.5—2.2mg／mL blood) antifreeze vacuum tube to collect venous blood sample. Mix the venous blood and anticoagulant immediately. Prepare 3-5 copies of normal fresh blood by using the above method.

7.4.2 Fresh Blood Calibration Note: Fresh blood calibration need to be conducted under “Whole Blood” and “Pre-dilution” testing mode. Click “Fresh Blood Calib” in figure 7-3-1 to enter fresh blood calibration interface, as shown in figure 7-4-1.

100


Figure 7-4-1

7.4.2.1 Whole Blood Calibration （a）Select the number of fresh blood calibration in the drop down list behind “No.” To reselect its “No.” after each fresh blood sample is tested for 5 times. （b）Put the prepared fresh blood in the instrument to test three times, and calculate the mean value. The mean value will be taken as reference value and input in figure 7-4-1. （ c ） Put the fresh blood under sampling probe, and press “Sample Aspiration”, the sampling probe will aspirate 20uL fresh blood and start calibration counting automatically.

Figure 7-4-2 （d）After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient calculation. 5 times counting is recommended. As the increase of calibration times, CV and calibration coefficient will be updated. （e）Analyzer will carry out different process according to different results.

101

BF-6500 Automatic Hematology Analyzer User Manual The following box will pop up if the results obtained beyond the scope.

Figure 7-4-3 Click “OK” to close the box and clear the result of this counting. The result will be displayed on the calibration interface only if the counting result is valid. When saving the counting result after obtaining 3 or more counting result, if the calibration coefficient of certain parameter is not within 75%-125%, click “Save”, the following box will pop up:

Figure 7-4-4 Operator should check the reference value input, if the reference value input is correct, operator delete calibration results, re-run the calibration count. （f）Calibration Result Deleting. If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating this result is not counted during CV, mean, calibration coefficient calculation. If this result deletion is not needed after test, click “Test Result” again(mark √ ), indicating this test result is valid. If this result is invalid, click “Delete” to delete the result. （g）Calibration coefficient saving： Click “Save” in figure 7-4-1 after 5 times counting, the following box will pop up.

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Figure 7-4-5 Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of “Manual Calibration” interface.

7.4.2.2 Peripheral Blood Calibration Refer to 4.3.2 for peripheral blood preparation. Refer to 7.4.2.1 for operation.

7.5 Manual Calibration The calibration coefficient displayed on the screen is the calibration coefficient saved after calibration with calibrator or fresh blood calibration. Click “Manual Calibration” in figure 7-4-1 to enter manual calibration interface. As shown in figure 7-5-1.

Figure 7-5-1

（a） Click the corresponding line under “Calibration Coefficient” when the calibration 103

BF-6500 Automatic Hematology Analyzer User Manual coefficient needs adjustment, and input the calibration coefficient, click “Save”, “Save succeed” will pop up, click “OK”.

7.6 Calibration Log The software registers information of each calibration. Click “Calib History” in figure 7-5-1 to enter calibration log interface, as shown in figure 7-6-1.

Figure 7-6-1 The date, mode, calibration method and detail test value of latest 30 times calibration will be displayed. If calibration counting is more than 30 times, the previous calibration result will be covered. Query: Operator can query the calibration log according to log date, username, calibration mode and calibration method.

104


Chapter 8 Service In order to ensure the normal running of the instrument, routine maintenance is required. The instrument will prompt the user to conduct maintenance after testing a certain number of sample or a continuous working period. The service menu in the instrument offers routine maintenance methods and failure solutions, but users should make their own maintenance plan according to daily sample number, operating environment, running time, etc. to reduce the impact of various factors and ensure the safe, stable and effective running of the instrument. Note: ● Improper maintenance may damage the instrument. The manual must be followed in maintenance. ● Contact Dirui's after-sales service department for unclear answers of the manual.

8.1 Maintenance Guide 8.1.1 Regular Maintenance ● Daily: QC should be conducted before daily analyzing. Refer to chapter 6 for QC operation. If the instrument is on for 24 hours, daily “WBC Pool Rinsing", “RBC Pool Rinsing”, “DIFF Pool Rinsing” operation should be conducted(service-maintenance-rinsing). ● Every week: If normal shutdown operation is conducted every day, " Detergent Soaking" （WBC Pool, RBC Pool, DIFF Pool）should be conducted every week.（service-maintenance）. ● Every month: Swab rinsing should be conducted each month if daily shutdown is conducted(ServiceMaintenance-Rinsing).

8.1.2 Maintenance in Need 105


● If the counting pool has been contaminated, conduct “Counting Pool Rinsing". ●When the analyzer has not been used for 2 weeks or more, repalce the reagent with distilled water, conduct "Rinse Pipeline" of "Maintenance", and stop the distilled water, conduct "Empty Pipeline", and place the analyzer at a clean place. ● When the instrument prompt "clog" failure, press “Remove” to conduct manual remove or conduct " Zap " and " Backflush ". ● Carry out priming if it has not been used for a long time. ● The instrument will prompt “Soaking with Detergent” if the set counting number of software has been conducted. ●The reliable results can be obtained under the condition of normal working environment and state. ● See the failure solution if other failure information is prompted.

8.2 System Status System status is used to display the current status. Basic status, system version can be checked in this interface.

8.2.1 System Version

Click service, and click

in front of System Version, and select Software, the screen displays

as figure 8-2-1:

106


Figure 8-2-1 Version number of software and algorithm library is displayed. Select Mainboard, as figure 8-2-2 shows:

Figure 8-2-2 Version of software and hardware, upgrade pack are displayed. Version number of control board, collection board, temperature control board, sampler control board and mechanical version can be checked by using the same method. Select “Instrument Information” in its drop down menu, as figure 8-2-3 shows:

107


Figure 8-2-3 It has been set before delivery. Therefore, it can only be checked. Note: Version No. of above figure is only for reference.

8.2.2 Basic Status Select “Basic Status” in figure 8-2-2, the screen display as figure 8-2-4:

Figure 8-2-4 Status explanation: (a)Temperature ： Real-time temperature of reaction pool, working environment and laser, and also the normal range. (b)Pressure：Pressure of pressure reducing valve and normal pressure range. (c)Voltage：Display 55V, 5V, voltage of WBC aperture, RBC aperture and normal range. 108

BF-6500 Automatic Hematology Analyzer User Manual (d)Current：Display the normal range and power adjust valve of laser current.

8.3 Mechanical Detect Click

in front of “Detect” in figure 8-2-4, and select “Mechanical Detect”, as shown in figure

8-3-1:

Figure 8-3-1

8.3.1 Motor Detect When some moving parts failure occur, motor detection can be conducted to judge the failure. The following motors detection has been set in this program: Y axis motor, X axis motor, diluent motor, lyse motor, whole blood aspiration motor and test motor. Click “Test”, the result will be displayed on the screen(Succeed or Failed).

8.3.2 Valve Detection Valve failure will lead to abnormal work of the instrument. Therefore, value detection is an important way to solve pipeline failure. Its operation is as follow: Click the No. of the valve(No. of figure 8-4 indicate valves), the analyzer will conduct valve detection automatically. Valve ON sound indicates normal valve. The valves with grey No. can not be detected. 109


8.3.3 Pump Detection Click “Positive Pressure” or “Negative Pressure” to check the pump voltage. Note: Valve detection and voltage detection can not be conducted at the same time. Click “Exit” after test to exit the interface.

8.4 System Maintenance In order to protect the normal and accurate running of the analyzer, the software provides a number of maintenance functions.

8.4.1 Replacement / Priming Note: Carry out background test after diluent, lyse replacement. Sample test can be conducted when the background result is within normal range. The following range is the normal range of background test: a）RBC≤0.05×1012/L b）WBC≤0.5×109/L c）HGB≤2g/L d) PLT≤10×109/L Click

in front of “Maintain” in figure 8-3-1, and select “Replace/Prime”, as figure 8-4-1 shows:

110


Figure 8-4-1

（a）FDO Lyse Replacement： Click Replace FDO when bubble exits in FDO pipeline, or FDO reagent is polluted, or FDO reagent has been used up.

Figure 8-4-2 Click OK，pop up progress bar as shown in Figure 8-4-3：

Figure 8-4-3 111

BF-6500 Automatic Hematology Analyzer User Manual After replacing FDO lyse, the following box will pop up:

Figure 8-4-4 Click “OK” to finish the replacement of FDO. Click “Cancel” in figure 8-4-2 to cancel FDO replacement.

（b）FDT Lyse Replacement： Click Replace FDT when bubble exits in FDT pipeline, or FDT reagent is polluted, or FDT reagent has been used up. The confirm interface will pop up. Click OK ， pop up progress bar ”Replacing FDT About 3 mins…”, After replacing FDT lyse, “Operation finished” box will pop up, click OK to finish the replacement. Click “Cancel” to cancel FDT replacement.

（c）SLS Lyse Replacement： Click Replace SLS when bubble exits in SLS pipeline, or SLS reagent is polluted, or SLS reagent has been used up. The confirm interface will pop up. Click OK ， pop up progress bar ”Replacing SLS About 3 mins…”, After replacing SLS lyse, “Operation finished” box will pop up, click OK to finish the replacement. Click “Cancel” to cancel SLS replacement.

（d）Diluent Replacement： Click Replace Diluent when bubble exits in Diluent pipeline, or Diluent is polluted, or Diluent has been used up. The confirm interface will pop up. Click OK ， pop up progress bar ”Replacing Diluent About 5 mins…”, After replacing Diluent, “Operation finished” box will pop up, click OK to finish the replacement. Click “Cancel” to cancel Diluent replacement.

（e）FDO Priming： Click Prime FDO when FDO Lyse being emptied. The following box will pop up:

112


Figure 8-4-5 Click OK, as shown in Figure 8-4-6：

Figure 8-4-6 The following box will pop up after FDO priming.

Figure 8-4-7 Click OK to finish the priming of FDO. Note: In the "fault information area", clear the corresponding error message, the instrument automatically conduct FDO lyse priming when the software prompt FDO insufficiency. (f) FDT Priming: Click “Prime FDT” after FDT is emptied. And the operation should be conducted as the prompts. Or: In the "fault information area", clear the corresponding error message, the instrument automatically conduct FDT lyse priming when the software prompt FDT insufficiency. (g) SLS Priming: Click “Prime SLS” after SLS is emptied. And the operation should be conducted as the prompts. Or: In the "fault information area", clear the corresponding error message, the instrument automatically conduct SLS lyse priming when the software prompt SLS insufficiency. 113

BF-6500 Automatic Hematology Analyzer User Manual (h) Diluent Priming: Click “Diluent Priming” after Diluent is emptied. And the operation should be conducted as the prompts. Or: In the "fault information area", clear the corresponding error message, the instrument automatically conduct Diluent priming when the software prompt Diluent insufficiency. (i) Detergent Priming: Click “Detergent Priming” after Detergent is emptied. And the operation should be conducted as the prompts. Or: In the "fault information area", clear the corresponding error message, the instrument automatically conduct Detergent priming when the software prompt Detergent insufficiency.

8.4.2 Rinsing Select “Rinse” in figure 8-4-1, as figure 8-4-8 shows:

Figure 8-4-8 (a) Conduct WBC pool rinsing when the background test value of WBC or HGB parameter is abnormal. Click Rinse WBC in figure 8-4-8. As shown in figure 8-4-9.

114


Figure 8-4-9 Click OK，progress bar will pop up as shown in Figure 8-4-10：

Figure 8-4-10 “Operation Complete” will pop up after WBC pool rinsing, click OK to finish the whole process. Click “Cancel” in figure 8-4-9 to cancel WBC pool rinsing.

(b) Conduct RBC pool rinsing when the background test value of RBC or PLT parameter is abnormal. Click Rinse RBC in figure 8-4-8. Confirm box will pop up, click OK，progress bar will pop up. “Operation Complete” will pop up after RBC pool rinsing, click OK to finish the whole process. Click “Cancel” to cancel RBC pool rinsing in confirm box.

(c) Conduct DIFF pool rinsing when the WBC-diff parameter is abnormal. Click Rinse DIFF in figure 8-4-8. Confirm box will pop up, click OK，progress bar will pop up. “Operation Complete” will pop up after DIFF pool rinsing, click OK to finish the whole process. Click “Cancel” to cancel DIFF pool rinsing in confirm box. (d) In order to avoid sampling component contamination, swab rinsing should be conducted after one month’s running. Click “Rinse Swab” in figure 8-4-8. The confirm box will pop up, click OK, as figure 8-4-11 shows:

115


Figure 8-4-11 Place the detergent used for probe rinsing under sampling probe and press sample aspiration key. Progress bar will pop up. “Operation Complete” will pop up after swab rinsing, click OK to finish the whole process. Click “Cancel” to cancel swab rinsing in confirm box. (e) Bubble may exists in flow cell when magnified cell mass exists in scattergram and the background testing value of WBC parameter is higher than normal value. “Sheath Pool Rinsing” should be conducted at this time. The operation is as follow: Click Rinse Sheath Flow Pool in figure 8-4-8. Confirm box will pop up, click OK ，progress bar will pop up. “Operation Complete” will pop up after rinsing, click OK to finish the whole process. Click “Cancel” to cancel sheath pool rinsing in confirm box. (f)If bubble exists in sample aspiration pump or the test values are lower after reagent replacement. “Debubble Sample Pump” should be conducted. Click “Debubble Sample Pump” in figure 8-4-8. Confirm box will pop up, click OK，progress bar will pop up. “Operation Completed” will pop up after debubble, click OK to finish the whole process. Click “Cancel” to cancel debubble in confirm box.

8.4.3 Maintenance Click “Maintain” in figure 8-4-8, as shown in figure 8-4-12.

116


Figure 8-4-12

8.4.3.1 Emptying In order to avoid liquid spill during pipeline maintenance, empty should be conducted first. Taken waste liquid buffer bottle as an example: (a)Click Empty WC to empty the corresponding bottle and the pipeline. The following box will pop up.

Figure 8-4-13 Click OK in above figure to conduct empty WC. Progress bar will pop up. “Operation Complete” will pop up after emptying, click OK to finish the whole process. Click “Cancel” to cancel the emptying in confirm box. The operation of “Empty PK”, “Empty WBC”,“Empty RBC”,“Empty DIFF”,“Empty FDO”,“Empty FDT”,“Empty SLS” and“Empty Diluent” is same as “Empty WC”. After emptying waste pool 1, return to the interface shown in Figure 8-19. 117

BF-6500 Automatic Hematology Analyzer User Manual (b) Click “Empty Pipeline” in figure 8-4-12 when the analyzer will not be used for 1-2 days. Place the analyzer at a clean position after pipeline emptying. (c)Replace the reagent with distilled water when the analyzer will not be used for more than 1 week. Click “Package Clean Pipe” in figure 8-4-12. Place the analyzer at a clean position after above two steps.

8.4.3.2 Aperture Aperture clog remove, zap and backflush should be conducted in order to clear the debris in aperture. Click “Zap”, the following box will pop up:

Figure 8-4-14 Click “OK” in above figure, to clean the aperture through high-voltage direct current. The progress bar will pop up meanwhile. Click “Backflush”, the confirm box will pop up, click “OK” to flush it. The progress bar will pop up meanwhile. Together with zap, the RBC aperture clog can be removed. Click “Clog Remove”, the confirm box will pop up, click “OK” to zap and flush the aperture. The progress bar will pop up meanwhile.

8.4.3.3 Soaking with Detergent In order to ensure the accuracy of the test result, detergent soaking of WBC pool, RBC pool and DIFF pool assembly should be conducted in the following conditions:

·Scattergram of test result is abnormal. ·Aperture clog failure. ·Detergent soaking prompted by the software. (a)RBC Pool Soaking： RBC pool soaking should be conducted every other month, the operation is as follow: Click “RBC Pool” in figure 8-4-12, as figure 8-4-15 shows: 118


Figure 8-4-15 Click “OK” in above figure, as figure 8-4-16 shows:

Figure 8-4-16 Place the prepared probe detergent under sample probe, and press aspiration key. The detergent will be dispensed into RBC pool, as the following figure shows:

Figure 8-4-17 The following box will pop up after soaking:

Figure 8-4-18 Click “Next” in figure 8-4-18 to empty RBC, as the following figure shows: 119


Figure 8-4-19 Operation has been finished after emptying, as the following figure shows:

Figure 8-4-20 Click “OK” to finish the whole process. (b)WBC Pool Soaking： WBC pool soaking should be conducted every other week, the operation is as follow: Click “WBC Pool” in figure 8-4-12, as figure 8-4-21 shows:

Figure 8-4-21 Click OK in above figure, as 8-4-16 shows. Place the prepared probe detergent under sample probe, and press aspiration key. The detergent will be dispensed into WBC pool, as the following figure shows:

120


Figure 8-4-22 Click “Next” in figure 8-4-18 to empty WBC, as the following figure shows:

Figure 8-4-23

(c) DIFF Pool Soaking： DIFF pool soaking should be conducted every other week, the operation is as follow: Click “DIFF Pool” in figure 8-4-12, as figure 8-4-24 shows:

Figure 8-4-24 Click OK in above figure. The DIFF pool will be emptied. As figure 8-4-25, 8-4-26 shows:

Figure 8-4-25 121


Figure 8-4-26 Aspirate 1ml shutdown liquid with injector, and add it into DIFF pool, as figure 8-4-27 shows:

Figure 8-4-27 Click “OK” in figure 8-4-26 after liquid adding. As figure 8-4-28 shows:

Figure 8-4-28 Figure 8-4-29 will pop up after soaking, indicates whole process is finished.

Figure 8-4-29

8.4.4 Reagent Registration Click “Reagent Register” in figure 8-4-12, the screen display as figure 8-4-30 shows: 122


Figure 8-4-30 （a）Input the barcode information manually： Manual barcode information input can be conducted if the external barcode scanner is not connected. Click barcode input box in figure 8-4-30 to input the information according to the reagent package. Click OK after input. Left times: Scanning a barcode information for each, the remaining number will change accordingly (with the reagent in proportion to the size of bottle). （b）Scan barcode information Connect the barcode reader( connect the data wire of barcode reader with computer) , click the input box behind “Barcode” to turn into available status, scan the barcode outside the package box with barcode reader, screen prompts "× × × register ok" and the barcode. （c）Prompts for scanning failure The following information will be prompted if scanning failed:

123


Figure 8-4-31 Input the information after checking if above condition occur. Contact DIRUI or his distributor for continuous failure. The following box will pop up if the barcode has been used:

Figure 8-4-32 Change another bottle of reagent if above condition happened. Note: Do NOT stare at the scanning beam during analyzer running to avoid eye injury.

8.5 Replacement of Wearing Components 8.5.1 Replace Syringe Pump Syringe pump should be replaced after long time using.The detail steps are as follow: Counting for 100 samples/day, sample aspiration pump, test pump and lyse pump(including SLS pump, FDO pump and FDT pump)should be replaced once in 21 months. Pump used for diluent should be replaced once in 14 months. The pump positions are as follow:

124


Sample Pump

Figure 8-5-1

① ② ③

④ ⑤

Figure 8-5-2 ①SLS Syringe Pump

②FDO Syringe Pump

③FDT Syringe Pump ④Diluent Pump

⑤Test Pump

8.6 System Log

Click “Log” in main interface, and select “Error Log” in its drop-down list

figure 8-6-1 shows:

125

, as


Figure 8-6-1 The operator can also select “Operation Log” and “Failure Log” in its drop-down list for checking.

126


Chapter 9 Instrument Transportation and Storage 9.1 Transportation Requirement The instrument should be protected from water, severe vibration and squeeze. Handling, loading and unloading should be carried out lightly.

9.2 Storage Requirement Altitude: below 2000 meters. Temperature Range: -10 ℃ ~ 40 ℃. Relative Humidity: 30% ~ 75%. Barometric Pressure: 76kPa ~ 106kPa.

127


Chapter 10 Failure Handling This chapter describes various types of possible failure, the reason of the failure, and the solutions. Note： Test the result in case of failure may cause inaccurate result. If alarm is prompt in the process of testing, failure solution should be adopted first.

10.1 Overview See the following relative failure solution if failure occur during working process. Alarm information will be prompted in failure information area if failure occurs. Click the failure, figure 10-1-1 will pop up:

128


Figure 10-1-1 Failure information name and help will be displayed. Name of failure information will be displayed according to the order of the failure. The failure solution can be checked in detail information. Press “Clear” to clear the failure information. Click “Exit”.

10.2 Failure Information and Solution Alarm Information Solution Diluent bottle is empty. 1.Check the diluent. 2. Replace a new bottle of diluent if there is no diluent. Click “Clear” to prime diluent. 3.Check the float switch if diluent is sufficient. Replace it if it is not usable. HGB background 1.Please check whether the diluent has been polluted. exceeds range. 2.Click “Clear” to solve it if the diluent is not polluted. 5V voltage exceeds 1.Click “Clear” to solve it. range. 2.Replace the circuit board if problem can not be solved. WBC aperture voltage 1.Click “Clear” to solve it. exceeds range. 2.Replace the circuit board if problem can not be solved. 55V voltage exceeds 1.Click “Clear” to solve it. range. 2.Replace the circuit board if problem can not be solved. RBC aperture voltage 1.Click “Clear” to solve it. exceeds range. 2.Replace the circuit board if problem can not be solved. Laser current exceeds 1.Click “Clear” to solve it. range. 2.Replace the circuit board if problem can not be solved. FDO empty 1.Check the FDO. 2. Replace a new bottle of FDO if there is no FDO. Click “Clear” to prime it. 3.Check the float switch if FDO is sufficient. Replace it if it is not usable. 129

BF-6500 Automatic Hematology Analyzer User Manual Lyse motor error

1.Click “Clear” to solve the problem. 2.Check lyse motor if problem is not solved. Contact service engineer of DIRUI if lyse motor is not available. Lyse motor sensor error 1.Click “Clear” to solve the problem. 2.Check lyse motor sensor if problem is not solved. Contact service engineerof DIRUI if lyse motor sensor is not available. Dilluent buffer bottle 1.Check the diluent. empty 2.Replace a new bottle of diluent if there is no diluent. Click “Clear” to prime diluent. 3.Check the float switch if diluent is sufficient. Replace it if it is not usable. 4.Check valve 6 or 12 if float switch is working well. Contact service engineer of DIRUI if valve is not available. Voltage error 1.Click “Clear” to solve this problem. 2.Check the air pipes connection. 3.Check the air pump if this problem remains. Contact service engineer of DIRUI if air pump is not available. 4.Contact engineer to adjust the voltage regulating valve if this problem remains. Y axis motor sensor 1.Click “Clear” to solve the problem. error 2.Check Y axis motor sensor if problem is not solved. Contact service engineer of DIRUI if Y axix motor sensor is not available. Diluent motor error 1.Click “Clear” to solve the problem. 2.Check diluent motor if problem is not solved. Contact service engineer of DIRUI if diluent motor is not available. Diluent motor sensor 1.Click “Clear” to solve the problem. error 2.Check diluent motor sensor if problem is not solved. Contact service engineer of DIRUI if diluent motor sensor is not available. SLS empty 1.Check the SLS. 2. Replace a new bottle of SLS if there is no SLS. Click “Clear” to prime it. 3.Check the float switch if SLS is sufficient. Replace it if it is not usable. Data collection board 1.Click “Clear” to solve the problem. verification error 2.Check data collection board if problem is not solved. Contact service engineer of DIRUI if data collection board is not available. Data collection board is 1.Click “Clear” to solve the problem. not connected 2.Check the connection of data collection board. 3.Check whether the board is damaged if failure remain exists. Contact service engineer of DIRUI if board is damaged. Laser over-temperature 1.Click “Clear” to solve the problem. 2.Check whether the heater is damaged if failure remain exists. Contact service engineer of DIRUI if heater is damaged. 3.Check whether the thermistor is damaged if failure remain exists. Contact service engineer of DIRUI if thermistor is damaged. 4.Check whether the thermal protector is damaged if failure remain exists. Contact service engineer of DIRUI if thermal protector is damaged. Laser low-temperature 1.Click “Clear” to solve the problem. 2.Check whether the heater is damaged if failure remain exists. Contact service engineer of DIRUI if heater is damaged. 130

BF-6500 Automatic Hematology Analyzer User Manual 3.Check whether the thermistor is damaged if failure remain exists. Contact service engineer of DIRUI if thermistor is damaged. 4.Check whether the thermal protector is damaged if failure remain exists. Contact service engineer of DIRUI if thermal protector is damaged. Laser temperature 1.Click “Clear” to solve the problem. sensor is not connected 2.Check the connection of temperature sensor. 3.Check whether the sensor is damaged if failure remain exists. Contact service engineer of DIRUI if sensor is damaged. Room over1.Click “Clear” to solve the problem. temperature 2. Please make sure the ambient temperature is within normal range [15，30]℃. 3.Replace the temperature sensor if failure remains. Room low-temperature 1.Click “Clear” to solve the problem. 2. Please make sure the ambient temperature is within normal range [15，30]℃. 3.Replace the temperature sensor if failure remains. Room temperature 1.Click “Clear” to solve the problem. sensor is not connected 2.Check the connection of temperature sensor. 3.Check whether the sensor is damaged if failure remain exists. Contact service engineer of DIRUI if sensor is damaged. WBC pool over 1.Click “Clear” to solve the problem. -temperature 2.Check whether the heater is damaged if failure remain exists. Contact service engineer of DIRUI if heater is damaged. 3.Check whether the thermistor is damaged if failure remain exists. Contact service engineer of DIRUI if thermistor is damaged. 4.Check whether the thermal protector is damaged if failure remain exists. Contact service engineer of DIRUI if thermal protector is damaged. WBC pool low 1.Click “Clear” to solve the problem. -temperature 2.Check whether the heater is damaged if failure remain exists. Contact service engineer of DIRUI if heater is damaged. 3.Check whether the thermistor is damaged if failure remain exists. Contact service engineer of DIRUI if thermistor is damaged. 4.Check whether the thermal protector is damaged if failure remain exists. Contact service engineer of DIRUI if thermal protector is damaged. WBC pool temperature 1.Click “Clear” to solve the problem. sensor is not connected 2.Check the connection of temperature sensor. 3.Check whether the sensor is damaged if failure remain exists. Contact service engineer of DIRUI if sensor is damaged. Test motor error 1.Click “Clear” to solve the problem. 2.Check test motor if problem is not solved. Contact service engineer of DIRUI if test motor is not available. Test motor sensor error 1.Click “Clear” to solve the problem. 2.Check test motor sensor if problem is not solved. Contact service engineer of DIRUI if test motor sensor is not available. Waste barrel is full 1. Empty waste barrel or replace it with a new barrel. 2. Check the sensor and mainframe connection. 131

BF-6500 Automatic Hematology Analyzer User Manual 3. Check the float sensor. Contact service engineer of DIRUI if sensor is not available. Sample aspiration 1. Click “Clear” to solve the problem. motor error 2. Check the motor if failure remains. Contact service engineer of DIRUI if it is not available. Sample aspiration 1. Click “Clear” to solve the problem. motor sensor error 2. Check the motor sensor if failure remains. Contact service engineer of DIRUI if it is not available. Waste buffer bottle is Empty waste barrel or replace it with a new barrel. full X axis motor error 1. Click “Clear” to solve the problem. 2. Check the X axis motor if failure remains. Contact service engineer of DIRUI if it is not available. First sensor of X axis 1. Click “Clear” to solve the problem. motor error 2. Check the first sensor of X axis motor if failure remains. Contact service engineer of DIRUI if it is not available. Second sensor of X 1. Click “Clear” to solve the problem. axis motor error 2. Check the second sensor of X axis motor if failure remains. Contact service engineer of DIRUI if it is not available. Third sensor of X axis 1. Click “Clear” to solve the problem. motor error 2. Check the third sensor of X axis motor if failure remains. Contact service engineer of DIRUI if it is not available. Fourth sensor of X axis 1. Click “Clear” to solve the problem. motor error 2. Check the fourth sensor of X axis motor if failure remains. Contact service engineer of DIRUI if it is not available. X axis motor error 1. Click “Clear” to solve the problem. 2. Check the X axis motor if failure remains. Contact service engineer of DIRUI if it is not available. Y axis motor error 1. Click “Clear” to solve the problem. 2. Check the Y axis motor if failure remains. Contact service engineer of DIRUI if it is not available.

132


Appendix A

Network Communication Interface Protocol V1.1 A.1 This protocol is used for information transmission between BF-6500 Automatic Hematology Analyzer and LIS. It is based on HL7 standard, HL7 version is 2.4.

A.2 Terms MSH: each MSH head part is used for defining message purpose and aim, each message is made up by several message segments. The first segment in each MSH is always the message head segment. It indicates the sending and receiving program name and message type, and only message ID code, and following segment structure is decided by message type. For example, a sample message send by OBR segment, one test result information send by many OBX segment. Segment: each message segment is made up by several group of date fields, each message segment has name, and it is used for bounding the content or function. Such as Message Header (MSH), patient information (PID), case history (PV1) Field: segment made by several date field. Different date field are separated by list separator.

Syntax Format dddd : message start symbol (1byte). ASCII character, namely, 0x0B. dddd: data(made up by different length bytes). This is the HL7data content. Data could contain any byte value and ASCII code’s carriage return symbol greater than hex value 0x1F ,. : message end character(1 byte). ASCII character , namely, `0x1C. : carriage return (1 byte). ASCII character, namely, 0x0D.

Example: 133

BF-6500 Automatic Hematology Analyzer User Manual MSH|^~\&|LIS|1234567890|||20100427194802||ORU^R01|1|P^S|2.4| There into: 5 character after MSH are list separators used to differentiate each field, discreteness and subdiscreteness. Although those character could be any non-text character, but HL7 standard recommend following characters: Delimiter Field Separator Discreteness Separator Sub-Discreteness Separator Repeat Separator ESC

Value | ^ & ~ \

A.3 Message Segment Used in this Protocol MSH－message head PID－patient information PV1－case history OBR－test report information OBX－test report test information EQU –instrument detail NDS - instrument affiche detail

A.4 HL7 Attribute Table Message segment in the protocol could be divided into required, optional, and repeatable.

MSH Definition Table. MSH –message head: this message segment is required item ， includes HL7 message basic information, message separator value, message type and message coding method and so on, it is each HL7 message’s first message segment. Information Example: MSH|^~\&|BF-6500|1234567890|||20100419104618||ORU^R01|361|P^S|2.4|||||CHN| UNICODE Serial Field Name Length HL7 Advised Explanation Example NO. Length 1 Field 1 1 Include the first field separator | Separator after message segment, used for regulating other message field separator value 2 Coded 4 4 Include discreteness separator, ^~\& Character repeat separator, ESC, subdiscreteness separator 3 Send 7 180 Send terminal apply program BF-6500 Program value：BF-6500 4 Instrument 10 180 Sending terminal instrument, 123456789 Code value: instrument code 0 7 Send Time 14 26 Message created time （form 2011031 As 0144704 YYYY[MM[DD[HH[MM[SS]]]]]） 134

BF-6500 Automatic Hematology Analyzer User Manual ， Take system time value 9

Message Type

7

7

10

Message Control ID

20

20

11

Transact ID NO.

3

3

12

HL7 Version NO. Nation Code

3

60

3

3

Character Set

10

10

17 18

Message type, form as “information type” event type, value: ORU^R01(Sample) OUL^R21 （LJ/X、XB QC） Message control ID is used for only mark one message, value :PID This field is used for decide on whether to transact HL7 operation program’s(7th layer) transact rule definition information. Value: P^ message type（Type Value：S-sample、LJ-LJ /X barQC, XB-XB QC） Agreements adopt HL7 version No. Value: 2.4 Nation code mark, refer to HL 7 2.4 ISO/IEC 10646-1-1993 International character standard value: UTF-8

ORU^R01

361 P^S

2.4 CHN

UTF-8

PID： PID–patient information: this information segment is optional, used for patient sample transmission, include patient case history number, name, age, gender etc. Message Example PID||1234567890||| Wang San Qiang||| M Serial NO. 2

Field Name

5

Case History no. Name

8

Gender

Length 20

HL7 Advice Length 20

50

250

10

1

Explanation Patient ID, here used for patient case history NO. Patient name

Example 1234567890 Wang San Qiang

Gender, showed as character string

M

PV1 Definition Table PV1 –patient in hospital information : This message segment is optional, use for patient sample transmission, include patient department, bed NO., deliver doctor, examiner and so on. MEssage example: PV1||| clinic^^235689|||| doctor Wang| Zhang San| Li Si

135


Seria l NO. 3

Field Name Pointed

Length

HL7 Advice Length

Explanation

Example

80

80

form as :department^^bed no.

^^clinic 235689

50

250

deliver doctor, character string

doctor Wang

patient position 7

Deliver doctor

8

Examiner

50

250

examiner, character string

Zhang San

9

Auditor

50

250

auditor, character string

Li Si

OBR Definition Table OBR –testing report list information : This information segment is optional, mainly include test report information, include sample serial number, and scan No., tube rack No., deliver time and so on. Message example : OBR||23|31C3F010230DFB03|0001^Count Results||20071207080000|20071207160000|||||| |20071207083000||||2311|322 Seria l NO.

Field Name

Length

Sample Serial Number Scan No.

16

HL7 Advice Length 22

32

22

4

Data Service Type

200

200

6

Sample Time

14

26

7

Count Time

14

26

14

Delivery Time Tube Rack NO.

14

26

2

60

2 3

18

Explanation

Example

Sample number in testing Document No. in LJ/X QC

23

Barcode ID in sample testing Lot No. in LJ/X QC Service ID symbol, used for sign on different count result type. Idiographic value check the appendix OBR-4 message coding definition. Sampling time in testing. Validity in LJ/X quality control Counting time in sample information Count time in LJ/X QC Count time in X-B quality control delivery time.

31C3F010230DFB03

136

0001^Count Results

BF-6500 Automatic Hematology Analyzer User Manual 19

Tube NO.

2

60

OBX Definition Table OBX –Test result: this message segment is repeatable item, mainly include all test result parameter information and sample test mode, analysis mode and reference group, etc. Message example OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F Serial Field Length HL7 Explanation Example NO. Name Advice Length 1 Serial 10 10 Used for mark different OBX 1 NO.ID message segment 2 Data Type 3 3 Test result’s data type, value is ED “ST” 、 “NM” 、 “ED” 、 “IS” etc. 3 ID Symbol 250 250 Test item mark. Form as “ID ^ Name”, ID is test item mark, Name is test item descript information. Each test item serial no. value reference as appendix: identify coding definition. NOTE:ID used for only make one testing parameter, but name mainly for descript, not for mark. 5 test result, 65536 65536 Test result data, could be number, chart data, character string, enumerate value, notes, binary system etc, data specific quality value reference the enumerate control value table.( Binary data such as level…… histogram and scatter plot, using Base64 encoding to do conversion) 6 Unit 10 250 Unit, note: "^" in unit conflicts with 10*9/L discreteness separator, so use "*" to instead 7 Test 20 60 The scope of the test results, 12.463-33.569 Result forms: "the reference range lower Reference limit - upper limit of reference Value range" 11 Test 20 20 Test result condition. Value is “F” - F Result （Final Result）. Shows final test Condition results

This protocol use the custom coding approach.

OBR-4 Code Definition Code

Name

Explanation

OBR-4 Field

1001

Count Results

sample count result

1001^ Count Results

1002

LJ QC

LJ QC count result

1002^ LJ QC

137


XB QC

XB QC count result

1004^ XB QC

OBX-3 Identify Coding Definition Code

Name

Explanation

Value Type

OBX-3 Field

2001 2002

MODE MODE_EX

test mode analysis mode

IS IS

2001^MODE 2002^MODE_EX

2003

Ref

reference

IS

2003^Ref

2004

Age

age

NM

2004^Age

2005

Note

note

ST

2005^Note

2006

Level

L-J/X QC level

IS

2006^Level

2007

V_WBC

total white blood cell

NM

2007^V_WBC

2008

V_BAS_c

NM

2008^V_BAS_c

2009

V_NEU_c

NM

2009^V_NEU_c

2010

V_EOS_c

NM

2010^V_EOS_c

2011

V_LYM_c

NM

2011^V_LYM_c

2012

V_MON_c

NM

2012^V_MON_c

2013

V_BAS_p

NM

2013^V_BAS_p

2014

V_NEU_p

NM

2014^V_NEU_p

2015

V_EOS_p

NM

2015^V_EOS_p

2016

V_LYM_p

The number of basophils The number of neutrophils The number of acidic granulocyte The number of lymphocytes The number of mononuclear cells The percentage of basophils The percentage of neutrophils The percentage of eosinophils Lymphocyte percentage

NM

2016^V_LYM_p

2017

V_MON_p

NM

2017^V_MON_p

2018

V_RBC

NM

2018^V_RBC

2019

V_HGB

percentage of Monocytes The number of red blood cells Hemoglobin

NM

2019^V_HGB

2020

V_MCV

MCV

NM

2020^V_MCV

2021

V_MCH

NM

2021^V_MCH

2022

V_MCHC

NM

2022^V_MCHC

2023

V_RDW_CV

Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration Coefficient of variation of red blood cell distribution width

NM

2023^V_RDW_CV

138


V_RDW_SD

NM

2024^V_RDW_SD

V_HCT

Standard deviation of red blood cell distribution width Hematocrit

2025

NM

2025^V_HCT

2026

V_PLT

Platelet count

NM

2026^V_PLT

2027

V_MPV

Mean platelet volume

NM

2027^V_MPV

2028

V_PDW

NM

2028^V_PDW

2029

V_PCT

Platelet distribution width Platelet hematocrit

NM

2029^V_PCT

2030

V_P_LCR

NM

2030^V_P_LCR

2101

RBC Histogram.BIN PLT Histogram.BIN WBC Histogram.BIN DIFF Scattergram.BM P

Platelet - macrophage ratio RBC scattergram BMP data PLT scattergram BMP data WBC scattergram BMP data DIFF scattergram BMP data

2102 2103 2034

ED ED ED ED

2104

WBCD Scattergram.B MP

WBCD BMP data

scattergram

ED

2079

XB_Num

How many quality control in XB to generate a quality control

NM

2101^RBC Scattergram.BMP 2102^PLT Scattergram.BMP 2103^WBC Scattergram.BMP 2034^DIFF Scattergram.BMP 2104^WBCD Scattergram.BMP 2079^ XB_Num

Enumeration Type Data Item test mode analysis mode

Value

0- CBC

1- CBC+DIFF

0-open-whole blood 1-openpre-dilution 2-auto-whole blood 0- normal 1- M 2- F 3- Child 4- baby 5- custom 1 6- custom 2 7- custom 3 8- custom 4 9- custom 5 0- high 1- medium 2- low

reference

L-J/X QC level

139


Whole Information Segment Example 1． Patient Sample

MSH|^~\&|BF-6500||||20110310150421||ORU^R01|8|P^S|2.4|||||

CHN|UTF-8 PID||1234567890|||Wang Sanqiang|||Male PV1|||门诊^^235689||||Doctor Wang|Zhang San|Li Si

OBR||2|12345|1001^ Count Results||20110310112251| 20110310112409|||||| |20110310 112251||||0|0 OBX|1|IS|2001^MODE||0||||||F OBX|2|IS|2002^MODE_EX||1||||||F OBX|3|IS|2003^Ref||0||||||F OBX|4|IS|2004^Age||17|age|||||F OBX|5|ST|2005^Note||note position||||||F OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F OBX|7|NM|2008^V_BAS_c||4.63|10*9/L|11.00-12.00|L|||F OBX|8|NM|2009^V_NEU_c||4.63|10*9/L|11.00-12.00|L|||F OBX|9|NM|2010^V_EOS_c||4.63|10*9/L|11.00-12.00|L|||F OBX|10|NM|2011^V_LYM_c||4.63|10*9/L|11.00-12.00|L|||F OBX|11|NM|2012^V_MON_c||4.63|10*9/L|11.00-12.00|L|||F OBX|12|NM|2013^V_BAS_p||4.63|10*9/L|11.00-12.00|L|||F OBX|13|NM|2014^V_NEU_p||4.63|10*9/L|11.00-12.00|L|||F OBX|14|NM|2015^V_EOS_p||4.63|10*9/L|11.00-12.00|L|||F OBX|15|NM|2016^V_LYM_p||4.63|10*9/L|11.00-12.00|L|||F OBX|16|NM|2017^V_MON_p||4.63|10*9/L|11.00-12.00|L|||F OBX|17|NM|2018^V_RBC||4.63|10*9/L|11.00-12.00|L|||F OBX|18|NM|2019^V_HGB||4.63|10*9/L|11.00-12.00|L|||F OBX|19|NM|2020^V_MCV||4.63|10*9/L|11.00-12.00|L|||F OBX|20|NM|2021^V_MCH||4.63|10*9/L|11.00-12.00|L|||F OBX|21|NM|2022^V_MCHC||4.63|10*9/L|11.00-12.00|L|||F OBX|22|NM|2023^V_RDW_CV||4.63|10*9/L|11.00-12.00|L|||F OBX|23|NM|2024^V_RDW_SD||4.63|10*9/L|11.00-12.00|L|||F

140


OBX|24|NM|2025^V_HCT||4.63|10*9/L|11.00-12.00|L|||F OBX|25|NM|2026^V_PLT||4.63|10*9/L|11.00-12.00|L|||F OBX|26|NM|2027^V_MPV||4.63|10*9/L|11.00-12.00|L|||F OBX|27|NM|2028^V_PDW||4.63|10*9/L|11.00-12.00|L|||F OBX|28|NM|2029^V_PCT||4.63|10*9/L|11.00-12.00|L|||F OBX|29|NM|2030^V_P_LCR||4.63|10*9/L|11.00-12.00|L|||F OBX|30|ED|2101^RBC Scattergram.BMP||……BMP binary system data change to BASE64 code……||||||F OBX|31|ED|2102^PLT Scattergram.BMP||……BMP binary system data change to BASE64 code……||||||F OBX|32|ED|2103^WBC Scattergram.BMP||……BMP binary system data change to BASE64 code……||||||F OBX|33|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to BASE64 code……||||||F OBX|34|ED|2104^WBC Scattergram.BMP||……BMP binary system data change to BASE64 code……||||||F

2．L-J/X QC

MSH|^~\&|BF-6500||||20110311091016||OUL^R21||P^LJ|2.4||||| CHN|TUF-8 OBR||2|123 |1002^ LJ QC||20100819 |||||0|0 OBX|1|IS|2006^Level||0||||||F OBX|2|NM|2007^V_WBC||4.63||||||F OBX|3|NM|2008^V_BAS_c||4.63||||||F OBX|4|NM|2009^V_NEU_c||4.63||||||F OBX|5|NM|2010^V_EOS_c||4.63||||||F OBX|6|NM|2011^V_LYM_c||4.63||||||F OBX|7|NM|2012^V_MON_c||4.63||||||F 141

|20110217131356||||||


OBX|8|NM|2013^V_BAS_p||4.63||||||F OBX|9|NM|2014^V_NEU_p||4.63||||||F OBX|10|NM|2015^V_EOS_p||4.63||||||F OBX|11|NM|2016^V_LYM_p||4.63||||||F OBX|12|NM|2017^V_MON_p||4.63||||||F OBX|13|NM|2018^V_RBC||4.63||||||F OBX|14|NM|2019^V_HGB||4.63||||||F OBX|15|NM|2020^V_MCV||4.63||||||F OBX|16|NM|2021^V_MCH||4.63||||||F OBX|17|NM|2022^V_MCHC||4.63||||||F OBX|18|NM|2023^V_RDW_CV||4.63||||||F OBX|19|NM|2024^V_RDW_SD||4.63||||||F OBX|20|NM|2025^V_HCT||4.63||||||F OBX|21|NM|2026^V_PLT||4.63||||||F OBX|22|NM|2027^V_MPV||4.63||||||F OBX|23|NM|2028^V_PDW||4.63||||||F OBX|24|NM|2029^V_PCT||4.63||||||F OBX|25|NM|2030^V_P_LCR||4.63||||||F OBX|26|ED|2031^RBC Histogram.BIN||……BIN binary system data change to BASE64 code……||||||F OBX|27|ED|2032^PLT Histogram. BIN||……BIN binary system data change to BASE64 code……||||||F OBX|28|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to BASE64 code……||||||F 3．X-B QC

MSH|^~\&|

BF-6500||||20110311091040||OUL^R21||P^XB|2.4|||||

CHN| UTF-8 OBR||||1004^ XB QC|||20071207160000|||||||||||| OBX|1|NM|2079^XB_Num||20||||||F OBX|2|NM|2073^m_MCV_R||12.204||||||F 142


OBX|3|NM|2074^m_MCH_R||0.258||||||F OBX|4|NM|2075^m_MCHC_R||12.445||||||F OBX|5|NM|2076^m_MCV_L||45.859||||||F OBX|6|NM|2077^m_MCH_L||1.258||||||F OBX|7|NM|2078^m_MCHC_L||2.36||||||F OBX|8|NM|2020^V_MCV||4.63||||||F OBX|9|NM|2021^V_MCH||4.63||||||F OBX|10|NM|2022^V_MCHC||4.63||||||F

143


Appendix B

Report Designer User Guide The report can be modified or created through report designer setting to design the ideal report format. We offer the following two kinds of report template: ·With no graph, paper can be saved ·With graph, the default report format. In initial use, please save the template before modification. For the design of the template is debugged strictly, inappropriate changes may affect the printing. The following describes the specific function and use of the report designer. B.1 Report Designer Object Report designer is in the toolbar(left), a total of three objects: Icon

B.1.1

Name TextBox

Description Rectangular box which contain multiple lines of text. Allow

PictureBox Line

contain variable text. Display picture format of BMP，ICO，WMF，EMF and JPG Draw vertical or horizontal lines in report.

“TextBox”

Rectangular box which contain multiple lines of text. Type, color and width of frame, font attribute, text alignment and font direction (vertical or horizontal) can be set. Use ”Text” and ”Frame” tools to set the attribute of the object, as figure B.1 shows：

Figure B.1 Text box object includes: text, variables, data fields or any combination of these. Font formatting will be applied to all text included in text object. ·TextBox Modification: Click

on the left of Report Edit Designer, click the left mouse after rectangular icon appears,

as shown in figure B.2:

144


Figure B.2

Clipboard operation； Word wrap； Cancel button； OK button Note: data included in the database includes patient information, sample test information, the corresponding set of specific field will be detailed in the following chapter. B.1.2

“Picture Frame”

Picture can be inserted in the report. The format of the picture is BMP、WMF、ICO. ·Picture frame modification: Click

on the left of Report Edit Designer, click the left mouse after rectangular icon appears,

as shown in figure B.3:

145


Figure B.3

Click “Select..” in figure B.3, and click “OK”, the picture can be inserted into the report. B.1.3

“Line”

The horizontal or vertical line can be inserted in the report. In separate statement of the report, straight-line makes it easy to be read. The line thickness and color can be adjusted by using the drawing toolbar. Click

, drag the mouse in the current page, the cursor will turn into a pencil to draw a straight

line. Click the mouse to begin the line, release it when the line is finished. The line can be modified. ·Line modification: select the corresponding button in “frame toolbar” to modify the line. （a） “Standard”toolbar

(b)“Format”toolbar

(c)“Frame”toolbar

（d）“Alignment”toolbar

146


The use of the button is same as other software. B.2 Page Options B.2.1 Paper Set the page option for the current page of the report, select “File ｜ Page Setting”in designer menu, or double click blank area, as figure B.4 shows:

Figure B.4 Select the paper size of current printer in the drop down list of paper size. If the current printing support self-defined paper format, select "Self-defining", and then input the width and length of the paper format. Note: not all printer drive or printer support self-defining paper format (e.g. printer drive“HP LaserJet 6L”does not support 76*127mm size; printer drive“HP LaserJet 4L”does not support all self-defining size) B.2.2 Paper Source Click “Paper Source” in figure B.4, as figure B.5 shows:

Figure B.5 147

BF-6500 Automatic Hematology Analyzer User Manual Select the commonly used paper source. B.2.3 Margins Click “Margin” in figure B.4, as figure B.6 shows:

Figure B.6

If the "Extend to the printer" option is selected, the page form of designer will not display the border area. All regions of the page will be printed correctly. But the size is different in different printing. If this option is canceled, and all margin set to be 0, then the margin will be automatically set to the selected printer's maximum print area. When designed report switch from one printer to other printer (the printable area of ink jet printer is smaller than that of stylus printer), this function very useful. If the margin set to be non 0, margins will be reflected in a page from of the designer (marked with gray lines). If you use a dot matrix printer, first preview whether the print content is within the print area (some stylus printer will not print the content beyond printing scope, and other printer prompts the beyond print scope). In this case, set the margins manually. B.2.4 Other Click “Margin” in figure B.4, as figure B.7 shows:

148


Figure B.7 Set the number of columns and column spacing according to the page width. If the "print to front page" option is selected, it allows print the remaining area in the new page. B.3 Users create their own report sheet The report template we provided, list all data of patient test report and L-J QC report in detail. Open all selected objects of the report before create report sheet. The report template is in software installation directory, \ Print \ Sample: is patient sample report template ; \ Print \ QC: is QC report template. Concrete action : Open à select report àedit à Select All àNew Reportà Page SetupàPaste. In this new report, the position, font and the letter of text can be modified. B.3.1 Title： Set the sample test report and QC report in "System Setting". For example: × × × hospital, the title is × × × hospital test report. The “Test Report” can be set hereby. It can be modified into "Blood test report "," LJ report ", etc. The title can be modified into static text. B.3.2 Paper： Users also can modify the size of print paper. If the user use inkjet or laser printer and A4 paper, set paper A4. If the user use stylus printer (such as: epson 300K, 1600K, etc.), and use 80 column printing paper, set the paper to be self-defining. If a 80 column paper need to print three reports, set the paper to be 9.34(length). If a 80 paper need to print two reports, set the paper to be 14, paper width is 22. The default margin is 0. B.3.3 Select the object need to be modified： Click the object need to be modified with mouse (points around the selected object will appear), 149

BF-6500 Automatic Hematology Analyzer User Manual press Shift, more than one objects can be selected. Press Ctrl, and move the mouse meanwhile, then the mouse moved area will be selected. · Modify the letter of the static text: select the text need to be modified, and double click the textbox, input the modified letter in the corresponding box, and press “Enter”. · Modify the data field: If it is used to display certain data, only one textbox need to be added to appropriate position, double-click the text box, input the data value, refer to the existing template for the value. · Move object: select the object (more than one can be selected), then press the four buttons around "Move" to move the object, arrow keys on the keyboard can also be used. · Change size: select the object, press the up and down buttons of "high" or "width" to increase or decrease the height or width. · Change the font: Select the object, and then select the font size or bold, italic and so on. · Undo: error happened during modification, undo operation for one or more times, the report will return back to the style before modification. · Save: press the "Save" button after all operation is completed. Note: If it is patient sample report, please store in the software installation directory \ Print \ Sample folder; save quality control report into \ Print \ QC folder of software installation directory · Use: open the system setting in data management software, select the report in print setting.

150


Appendix C

Product Warranty Dear customer: Thank you for purchasing Automatic Hematology Analyzer of our company. We can offer you the following service: 1. Technique consultation is provided at any time. 2. One year warranty from the day purchased. 3. Paid service is provided in following condition: a. Product out of warranty period. b. Damage caused by accident or wrong operation. c. Operation is not according to the manual requirement. d. Repair the instrument without our permission. 4. Upgrading service is provided along with the technique improvement. For technique support, contact the following address and telephone: Manufacturer: Changchun Dirui Industrial CO., LTD. Address: 95, Yunhe Street, New & High Tech. Development Zone, Changchun, China Sales department telephone: 0431-85100409 After service telephone: 0431-81931012 Complain telephone: 0431-85191787 Fax :0431-85172581 151

BF-6500 Automatic Hematology Analyzer User Manual Zip code :130012 Email :[email protected] Website: http://www.dirui.com.cn

Europ Authorised Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands

Appendix D

Product Description

D.1 Product assortment: ①According to medical equipment product assortment catalogue: Belong to blood analyze system in clinic counting instrument (6840), type II in management type. ②According to electric shock protection assortment: typeⅠ D.2 Accessory reagent: ● Diluent ● BF-FDT ● BF-SLS-Ⅰ ● BF-FDO ● Shutdown liquid (Enzyme Detergent) D.3 Parameter Description

The parameter is obtained from histogram or scattergram. Name

Ab.

Unit

Lymphocyte Percentage

LYM％

％

Monocyte Percentage

Mon％

％

Neutrophil Percentage

Neu％

％

152

BF-6500 Automatic Hematology Analyzer User Manual Eosinophil Percentage

Eos%

％

Basophil Percentage

Bas%

％

Mean RBC Volume

MCV

fL

Variation coefficient of RBC width

RDW-CV

％

distribution Standard deviation of RBC width

RDW-SD

fL

distribution Mean Platelet Volume

MPV

fL

Platelet Width Distribution

PDW

％

The parameter is obtained from calculation. Name

Ab.

Unit

Lymphocyte Number

LYM#

109／L

Monocyte Number

Mon#

109／L

Neutrophil Number

Neu#

109／L

Eosinophil Number

Eos#

109／L

Basophil Number

Bas#

109／L

RBC Hematocrit

HCT

L／L

Mean RBC Hemoglobin

MCH

pg

Content Mean RBC Hemoglobin

MCHC

g／L

Concentration Platelet Hematocrit

PCT

％

153


Statement

Dirui Co., LTD. has the final explanation right. Dirui Co., LTD.is responsible for the security, reliability and capability of the product under the following circumstance: 1) Installation, adjustment, improvement and repair are conducted by Dirui company professionals. 2) Relevant electric equipment is qualified according to state norms. 3) User Manual should be obeyed when operating instrument. Please call 0431- 81931012 for any question. The manufacturer reserves the right to make changes without prior notice.

2011/6

154

BF-6500 Automatic Hematology Analyzer User Manual 1111

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