BC-5300 - Service Manual - V5.0 - EN PDF [PDF]

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BC-5300 / BC-5100



Auto Hematology Analyzer



Service Manual



© 2014 - 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2019-08.



Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. ,



,



China and other countries.



are the trademarks, registered or otherwise, of Mindray in All other trademarks that appear in this manual are used only for



informational or editorial purposes. They are the property of their respective owners.



Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: 



all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;







the electrical installation of the relevant room complies with the applicable national and local requirements; and







the product is used in accordance with the instructions for use.



I



WARNING 



It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.







Be sure to operate the analyzer under the situation specified in this manual; otherwise, the analyzer will not work normally and the analysis results will be unreliable, which would damage the analyzer components and cause personal injury.



NOTE 



This equipment must be operated by skilled/trained clinical professionals.



II



Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.



Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: 



Malfunction or damage caused by improper use or man-made failure.







Malfunction or damage caused by unstable or out-of-range power input.







Malfunction or damage caused by force majeure such as fire and earthquake.







Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.







Malfunction of the instrument or part whose serial number is not legible enough.







Others not caused by instrument or part itself.



Service Contact Company Name: Company Address:



Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China



Website: E-mail Address:



www.mindray.com [email protected]



Tel:



+86 755 81888998



Fax:



+86 755 26582680



EC-Representative: Address:



Shanghai International Holding Corp. GmbH(Europe) Eiffestraβe 80, 20537 Hamburg, Germany



Tel:



0049-40-2513175



Fax:



0049-40-255726



III



Table of Contents 1



Using This Manual....................................................................................................... 1-1 1.1



Scope ......................................................................................................................... 1-1



1.2



Conventions Used in This Manual ............................................................................. 1-1



1.3



Symbols ...................................................................................................................... 1-2



2



Product Specification ................................................................................................... 2-1 2.1



Equipment Name ....................................................................................................... 2-1



2.2



Intended Use .............................................................................................................. 2-1



2.3



Product overview ........................................................................................................ 2-1



2.4



Specified reagents and volume .................................................................................. 2-2



2.5



Minimum Sample Volume .......................................................................................... 2-2



2.6



Throughput ................................................................................................................. 2-2



2.7



Measurement Mode ................................................................................................... 2-2



2.8



Sample Types............................................................................................................. 2-2



2.9



Sampling mode .......................................................................................................... 2-3



2.10



Operation mode ......................................................................................................... 2-3



2.11



General performance requirements of the system ..................................................... 2-3



2.12



Parameter................................................................................................................... 2-4



2.13



Performance requirements ......................................................................................... 2-8 2.13.1.



Requirements of background ..................................................................... 2-8



2.13.2.



Requirements of Carryover ........................................................................ 2-8



2.13.3.



Reproducibility requirements ...................................................................... 2-9



2.13.4.



Linearity requirements .............................................................................. 2-10



2.13.5.



Display range of the main parameters ..................................................... 2-11



2.13.6.



Correlation requirements of the compare device ..................................... 2-12



2.13.7.



Correlation and accuracy requirements of the WBC differential parameters .................................................................................................................. 2-13



3



2.13.8.



Accuracy requirements............................................................................. 2-13



2.13.9.



Identification capability of the abnormal samples .................................... 2-14



Software System ......................................................................................................... 3-1 3.1



Overview .................................................................................................................... 3-1



3.2



Password Function ..................................................................................................... 3-1



3.3



Analyzer Software Upgrade ....................................................................................... 3-1



3.4



Software Installation and Upgrade ............................................................................. 3-4



3.5



3.4.1.



PC Configuration ........................................................................................ 3-4



3.4.2.



Hard disk partition ...................................................................................... 3-4



3.4.3.



IPU installation procedure .......................................................................... 3-4



3.4.4.



IPU upgrade ............................................................................................... 3-8



3.4.5.



IPU repair ................................................................................................... 3-8



Connection Setup of the IPU and Analyzer ................................................................ 3-9 3.5.1



Analyzer Network Setup ............................................................................. 3-9



1



Table of Contents



3.6



4



LIS Setup and Connection ....................................................................................... 3-10 3.6.1



LIS communication setup ......................................................................... 3-10



3.6.2



Unidirectional LIS communication ............................................................ 3-13



3.6.3



Error indication ......................................................................................... 3-15



3.6.4



Bidirectional LIS communication .............................................................. 3-16



3.6.5



Frequently asked questions and the answers .......................................... 3-17



Main Parameters Description ...................................................................................... 4-1 4.1.



Parameter source ....................................................................................................... 4-1



4.2.



WBC Measurement .................................................................................................... 4-3



4.3.



4.4.



4.2.1.



Flow Cytometry by Laser ........................................................................... 4-3



4.2.2.



Electrical Impedance Method ..................................................................... 4-4



4.2.3.



WBC Parameters ....................................................................................... 4-5



HGB Measurement .................................................................................................... 4-5 4.3.1.



Colorimetric Method ................................................................................... 4-5



4.3.2.



HGB ............................................................................................................ 4-5



RBC/PLT Measurement ............................................................................................. 4-5 4.4.1.



4.5.



4.6.



5



Electrical Impedance Method ..................................................................... 4-5



Time counting method ................................................................................................ 4-6 4.5.1.



Structure ..................................................................................................... 4-6



4.5.2.



Principle ...................................................................................................... 4-6



Parameter Flag Message Information ........................................................................ 4-6 4.6.1.



Flag Message ............................................................................................. 4-6



4.6.2.



Shield plan .................................................................................................. 4-9



4.6.3.



Sensitivity adjustment mechanism ........................................................... 4-10



Error Information of the Analyzer ................................................................................ 5-1 5.1.



6



Error Code .................................................................................................................. 5-1 5.1.1.



Pressure Testing ......................................................................................... 5-1



5.1.2.



Temperature Module .................................................................................. 5-1



5.1.3.



Syringe Module .......................................................................................... 5-4



5.1.4.



Sampling assembly module ..................................................................... 5-10



5.1.5.



Power voltage ........................................................................................... 5-15



5.1.6.



Analog signal board module ..................................................................... 5-15



5.1.7.



Reagent test type ..................................................................................... 5-18



5.1.8.



Flow cell clog ............................................................................................ 5-21



5.1.9.



Background abnormal .............................................................................. 5-22



5.1.10.



HGB abnormal.......................................................................................... 5-23



5.1.11.



Clog .......................................................................................................... 5-23



Fluidic System ............................................................................................................. 6-1 6.1.



Analysis Flow ............................................................................................................. 6-1 6.1.1.



WBC&HGB channel ................................................................................... 6-2



6.1.2.



DIFF & optical channel ............................................................................... 6-3



6.1.3.



RBC/PLT channel ....................................................................................... 6-3



2



Table of Contents



6.2.



Sample Volume .......................................................................................................... 6-4



6.3.



Temperature Control of the Fluidic System ................................................................ 6-4



6.4.



Reagent Volume ......................................................................................................... 6-5



6.5.



Introduction of Fluidic Components ............................................................................ 6-5



6.6.



6.7.



6.8. 7



6.5.1.



Mindray valves ........................................................................................... 6-5



6.5.2.



Two-way pressureproof Mindray valve....................................................... 6-6



6.5.3.



LVM fluidic valve ......................................................................................... 6-7



6.5.4.



Pinch valve ................................................................................................. 6-7



6.5.5.



Liquid filter .................................................................................................. 6-7



6.5.6.



Syringes ..................................................................................................... 6-8



6.5.7.



Pressure pump ........................................................................................... 6-9



6.5.8.



Vacuum pump ............................................................................................ 6-9



6.5.9.



Sample probe ........................................................................................... 6-10



6.5.10.



Probe wipe ............................................................................................... 6-10



6.5.11.



Pressure relief valve ................................................................................. 6-11



6.5.12.



Baths ........................................................................................................ 6-12



Introduction of Fluidic Structure ............................................................................... 6-13 6.6.1.



Sample aspiration and dispensing channel ............................................. 6-13



6.6.2.



WBC&HGB channel ................................................................................. 6-14



6.6.3.



WBC analysis ........................................................................................... 6-15



6.6.4.



HGB analysis ............................................................................................ 6-15



6.6.5.



DIFF & optical channel ............................................................................. 6-15



6.6.6.



RBC/PLT channel ..................................................................................... 6-16



Introduction of Sequences ....................................................................................... 6-17 6.7.1.



Analysis sequences of open vial whole blood CBC+DIFF mode ............. 6-17



6.7.2.



Analysis sequences of open vial predilute CBC+DIFF mode .................. 6-52



6.7.3.



Analysis sequences of the CBC mode ..................................................... 6-52



Function of Fluidic Valves ........................................................................................ 6-52 Optical System ............................................................................................................ 7-1



7.1.



Overview of Optical System Principle ........................................................................ 7-1



7.2.



Optical Path and Workflow of the Optical System ..................................................... 7-1



7.3.



Components of the Optical System............................................................................ 7-2



7.4.



Optical System Status Determination ........................................................................ 7-3



7.5.



Maintenance and Replacement of the Optical System .............................................. 7-5



7.6. 8



7.5.1.



Maintaining the Optical System .................................................................. 7-5



7.5.2.



Replacing the Optical System .................................................................... 7-9



Optical System Gain Calibration .............................................................................. 7-10 Hardware System ........................................................................................................ 8-1



8.1.



Overview .................................................................................................................... 8-1



8.2.



Diagram of Hardware System .................................................................................... 8-1



8.3.



Analog Board.............................................................................................................. 8-2 8.3.1.



Overview .................................................................................................... 8-2



8.3.2.



Function ...................................................................................................... 8-2



3



Table of Contents



8.4.



8.5.



8.6.



8.7.



8.8.



8.9.



8.3.3.



Structure ..................................................................................................... 8-3



8.3.4.



Interfaces .................................................................................................... 8-4



8.3.5.



Indicators and test points ........................................................................... 8-6



8.3.6.



Troubleshooting .......................................................................................... 8-7



Digital Control Board (including CPU module) ......................................................... 8-10 8.4.1.



Overview .................................................................................................. 8-10



8.4.2.



Function .................................................................................................... 8-10



8.4.3.



Structure ................................................................................................... 8-11



8.4.4.



Interfaces .................................................................................................. 8-11



8.4.5.



Indicators and test points ......................................................................... 8-12



8.4.6.



Troubleshooting ........................................................................................ 8-12



Drive Board .............................................................................................................. 8-13 8.5.1.



Overview .................................................................................................. 8-13



8.5.2.



Function .................................................................................................... 8-14



8.5.3.



Structure ................................................................................................... 8-15



8.5.4.



Interfaces .................................................................................................. 8-16



8.5.5.



Indicators and test points ......................................................................... 8-17



8.5.6.



Troubleshooting ........................................................................................ 8-19



Laser Control Board ................................................................................................. 8-20 8.6.1.



Overview .................................................................................................. 8-20



8.6.2.



Function .................................................................................................... 8-20



8.6.3.



Structure ................................................................................................... 8-20



8.6.4.



Interfaces .................................................................................................. 8-21



8.6.5.



Indicators and test points ......................................................................... 8-22



8.6.6.



Troubleshooting ........................................................................................ 8-23



Preamplification Board ............................................................................................. 8-25 8.7.1.



Overview .................................................................................................. 8-25



8.7.2.



Function .................................................................................................... 8-25



8.7.3.



Structure ................................................................................................... 8-25



8.7.4.



Interfaces .................................................................................................. 8-26



8.7.5.



Indicators and test points ......................................................................... 8-27



8.7.6.



Troubleshooting ........................................................................................ 8-27



Power Board............................................................................................................. 8-29 8.8.1.



Overview .................................................................................................. 8-29



8.8.2.



Function .................................................................................................... 8-29



8.8.3.



Structure ................................................................................................... 8-31



8.8.4.



Interfaces .................................................................................................. 8-32



8.8.5.



Indicators and test points ......................................................................... 8-34



8.8.6.



Troubleshooting ........................................................................................ 8-36



Fluid Detection Board ............................................................................................... 8-37 8.9.1.



Overview .................................................................................................. 8-37



8.9.2.



Function .................................................................................................... 8-37



8.9.3.



Structure ................................................................................................... 8-37



8.9.4.



Interfaces .................................................................................................. 8-38



4



Table of Contents



8.9.5.



Indicators and test points ......................................................................... 8-38



8.9.6.



Troubleshooting ........................................................................................ 8-39



8.10. Indicator Board ......................................................................................................... 8-39 8.10.1.



Overview .................................................................................................. 8-39



8.10.2.



Function .................................................................................................... 8-39



8.10.3.



Structure ................................................................................................... 8-40



8.10.4.



Interfaces .................................................................................................. 8-40



8.10.5.



Indicators and test points ......................................................................... 8-41



8.10.6.



Troubleshooting ........................................................................................ 8-41



8.11. Mini Network Board .................................................................................................. 8-41 8.11.1.



Overview .................................................................................................. 8-41



8.11.2.



Function .................................................................................................... 8-41



8.11.3.



Structure ................................................................................................... 8-42



8.11.4.



Interfaces .................................................................................................. 8-42



8.11.5.



Indicators and test points ......................................................................... 8-43



8.11.6.



Troubleshooting ........................................................................................ 8-43



8.12. List of Prefixes of Board Sockets ............................................................................. 8-44 8.13. Connections of Wires and Board ............................................................................. 8-45 8.14. Motors, Photocouplers and Micro-switches ............................................................. 8-49 8.15. Analyzer Status Indicated by the Indicators ............................................................. 8-50 9



Mechanical System ..................................................................................................... 9-1 9.1.



Analyzer Structure ...................................................................................................... 9-1



9.2.



Appearance ................................................................................................................ 9-1



9.3.



Layout Introduction ..................................................................................................... 9-3



9.4.



Sampling Assembly .................................................................................................... 9-4



9.5.



9.4.1.



Structure Introduction ................................................................................. 9-4



9.4.2.



Maintaining the Assembly .......................................................................... 9-7



9.4.3.



Replacing the X-Direction Start Position Sensors ...................................... 9-8



9.4.4.



Replacing X-Direction Detection Sensor .................................................... 9-9



9.4.5.



Replacing Y-Direction Sensor .................................................................... 9-9



9.4.6.



Replacing X-Direction Motor .................................................................... 9-10



9.4.7.



Replacing Y-Direction Motor ..................................................................... 9-12



Replace the Syringe Assembly ................................................................................ 9-13 9.5.1.



Structure Introduction ............................................................................... 9-13



9.5.2.



Relevant Troubleshooting Measures........................................................ 9-16



9.6.



Debug Screen Introduction ...................................................................................... 9-20



9.7.



Adjusting the Position of the Sample Probe ............................................................. 9-21



9.8.



9.7.1.



Sample Probe Up Position Adjustment .................................................... 9-21



9.7.2.



DIFF Bath Up Position Adjustment........................................................... 9-22



HGB Assembly Replacement ................................................................................... 9-22 9.8.1.



Maintenance Protocol .............................................................................. 9-23



5



1 



Using This Manual



Be sure to operate and service the analyzer strictly as instructed in this manual and the operator's manuals.



1.1 Scope To use this manual effectively, you need the following capabilities: 



Comprehensive knowledge of circuit and fluidics;







Comprehensive knowledge of reagents;







Comprehensive knowledge of controls;







Comprehensive knowledge of troubleshooting;







Mastering the way to operate this analyzer;







Mastering the way to operate this analyzer;







Using a digital voltmeter (DVM) and an oscilloscope;







Reading pneumatic/hydraulic schematics and understand related terminology.



Introduction This manual comprises 13 chapters and 1 appendix. Refer to the table below to find the information you need.



1.2 Conventions Used in This Manual When you read …



Click



It means … to press the desired item lightly with your finger; or to



left-CLICK it with the mouse. to CLICK the desired edit box and use the external keyboard



ENTER



or the pop-up keyboard to enter the desired characters or digits; or to scan the number by using the bar-code scanner. to move the cursor to the character or digit that you want to



DELETE delete by clicking the left button of the mouse or using



1-1



Using This Manual



When you read …



It means … [←][→][Home][End], and then delete the character after the cursor by pressing [Del], or delete the character before the cursor by pressing [BackSpace] ([←] on the upper right part of the soft keyboard). to CLICK the arrow buttons at the ends of the scroll bar; or to



DRAG SCROLL BAR



CLICK and hold the mouse button down while dragging the scroll bar until the desired information is displayed; or to touch the scroll bar and rest your finger there until the desired information is displayed. to CLICK the down arrow button of the desired box to display



SELECT from ××



the pull-down list, (and DRAG SCROLL BAR) to browse and



pull-down list



then CLICK the desired item; or to press the keys



(for pull-down list)



([↑][↓][PageUp][PageDown]) to browse the current list and press [ENTER] to select the desired item.



1.3 Symbols You will find the following symbols in this manual.



When you see…



Then… read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is alerting you to information that requires your attention. read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition.



1-2



Using This Manual



You may find the following symbols on the analyzer, reagents, controls or calibrators.



When you see…



It means… Note: suggesting the users consult to accompanying documents to get important safety information. BIOLOGICAL RISK



CAUTION, RISK OF ELECTRIC SHOCK



WARNING, LASER BEAM



CAUTION, HOT SURFACE



PROTECTIVE EARTH (GROUND)



EARTH (GROUND)



ALTERNATING CURRENT



FOR IN VITRO DIAGNOSTIC USE



TYPE B DEVICE



BATCH CODE



USE BY (YYYY-MM-DD)



SERIAL NUMBER



1-3



Using This Manual



When you see…



It means… DATE OF MANUFACTURE



MANUFACTURER



TEMPERATURE LIMITATION



CONSULT INSTRUCTIONS FOR USE



Be sure to observe the following precautions for the safety of patients and operators when you are servicing the analyzer.







It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or harm to human health.







Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol) around the analyzer. Otherwise, the risk of explosion may exist.







When servicing the analyzer, be sure to turn off the power. Servicing the analyzer when it is on may bring risk of electric shock or damage to electronic components.







Connect the analyzer to a socket having sole fuse and protective switch. Do not use the same fuse and protective switch with other equipment (e.g. life supporting equipment). Otherwise, the equipment failure, over current or impulse current that occurs at the startup moment may lead to tripping.







To prevent personal injury during maintenance, keep your clothes, hairs and hands from the moving parts, such as sample probe, clipper and piercer.







Possible mechanical movement of the warned position may lead to personal injury during the normal operation, removal and maintenance.







Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.







The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.



1-4



Using This Manual







If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.







Improper maintenance may damage the analyzer. Maintain the analyzer strictly as instructed by the service manual and inspect the analyzer carefully after the maintenance.







For problems not mentioned in the service manual, contact Mindray customer service department for maintenance advice.







To prevent personal injury or damage to equipment components, remove metal jewelry before maintaining or servicing electronic components of the equipment.







Electrostatic discharge may damage electronic components. If there is a possibility of ESD damage with a procedure, then do that procedure at an ESD workstation, or wear an antistatic wrist strap.







This equipment must be operated by skilled/trained medical professionals.







Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.







All the analyzer components and surfaces are potentially infectious. Take proper protective measures for operation or maintenance.







The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.



1-5



2



Product Specification



2.1 Equipment Name Name: Auto Hematology Analyzer Models: BC-5300, BC-5100



2.2 Intended Use The BC-5300 and BC-5100 are a quantitative, automated hematology analyzer and 5-part differential counter used in clinical laboratories. The purpose of this analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies. 



Scope: for in-vitro diagnostic and scientific research and application;







Operation environment: well-managed clinical laboratory, not used as portable device;







Operators: This equipment must be operated by skilled/trained clinical professionals.



2.3 Product overview BC-5300 and BC-5100 are the open-vial model of the low-end hematology analyzer. As the widespread model, it provide the functions of WBC, RBC and PLT measurements and WBC 5 differential with 27 parameters which are divided into 3 types (WBC, RBC and PLT), there are 4 RUO parameters for the WBC parameters. The 27 parameters are directly measured parameters and parameters calculated indirectly. WBC diff is realized by Flow Cytometry by Laser (which is dyed by chemical reagents and laser scattered method) , Electrical Impedance Method, the WBC is gained by Electrical Impedance Method; RBC, HCT and PLT count are gained by Electrical, HGB is gained by Colorimetric Method, and other parameters are gained by calculation. BC-5300 and BC-5100 use external PC computer, only the aspirate key is set on the device for interaction between people and device, while other operation required to be performed by the keyboard. The device has basic measurement and analysis function and can be connected to the hospital test department by the PC, printer and barcode scanner interface are also offered. The whole system is formed by BC-5300, BC-5100 and specified reagents, reagents, controls and calibrators.



2-1



Product Specification



2.4 Specified reagents and volume It is recommended to use reagents specified by Mindary, namely the 4 test reagents, 2 maintenance reagents, controls and calibrators. See table 2 for detailed requirements. Table 1



Specified reagents, controls, calibrators and volume Volume used for single sample



Components M-53diluent



M-53D DILUENT



CBC+DIFF



CBC



≤ 45mL



≤ 32mL



M-53LEO(I) LYSE M-53 lyse



0 ≤ 2.5mL



M-53LEO(II) LYSE



0 ≤ 1.0mL



M-53LH LYSE Probe cleanser Controls



M-53P PROBE CLEANSER RD(BC-5D)



/ /



Mindray(B55) Calibrators



RD(SC-CAL PLUS)



/



Mindray(S50) Note: the single diluent consumable under the predilute mode includes the diluent volume for dispensing the diluent.



2.5 Minimum Sample Volume The two measurements under whole blood mode require no more than 20ul and the Minimum Sample Volume is 0.5m, Ф12X75 (do not considering the size of the cap) evacuated blood collection tube; The two measurements under predilute blood mode require no more than 20ul.



2.6 Throughput whole blood mode: no less than 60 samples/hour. predilute blood mode: no less than 50 samples/hour.



2.7 Measurement Mode Measurement Mode: CBC，CBC+DIFF.



2.8 Sample Types Two sample types: whole blood and predilute blood. 2-2



Product Specification



Two measurement types can be used under two sample types.



2.9 Sampling mode Open vial (when the probe meets the tube bottom, it can still aspirate).



2.10 Operation mode Operation are performed by using the device key which include the switch, aspiration key and external keyboard. The run sequence and rules of the connection between analyzer and external PC. The following two operation can be performed without considering the sequence, the analyzer and PC are not required to be preconnected, and the analyzer and PC can perform the following operations independently: The startup and shutdown of the analyzer; Start up the PC and software; Only in the following condition the analyzer is powered on (Startup refers power on, initialization and normal count status): power on the analyzer, startup the software, input correct user name and password successfully and the software and analyzer can communicate normally.



2.11 General performance requirements of the system Table 2



General performance requirements of the system Item



Startup time(from power on to



Design requirements no more than 20 minutes



count status) requirements Power off time requirements of



no more than 15 minutes



the system



2-3



Product Specification



2.12 Parameter 1. Parameter classification Measure the WBC, RBC, PLT and HGB of the blood and output 27 Parameters, 3 histogram and 1scattergram, two measurement types CBC and CBC+DIF are offered as follows: Table 3 Parameter description Clone



Leukon 15 parameters



（



include 4 RUO parameters



） ，



Name



Abbreviation



CBC



CBC + DIFF



White Blood Cell count



WBC



*



*



Basophils number



Bas#



/



*



Basophils percentage



Bas%



/



*



Neutrophils number



Neu#



/



*



Neutrophils percentage



Neu%



/



*



Eosinophils number



Eos#



/



*



Eosinophils percentage



Eos%



/



*



Lymphocytes number



Lym#



/



*



Lymphocytes



Lym%



/



*



percentage Monocytes number



Mon#



/



*



Monocytes percentage



Mon%



/



*



Abnormal Lymphocytes



ALY#



/



*



ALY%



/



*



LIC#



/



*



LIC%



/



*



Red Blood Cell count



RBC



*



*



Hemoglobin



HGB



*



*



Corpuscular



MCV



*



*



Corpuscular



MCH



*



*



Corpuscular



MCHC



*



*



RDW-CV



*



*



number Abnormal Lymphocytes percentage Large Immature Cells number Large Immature Cells percentage



Concentration



RBC-related 8 parameters



（



）



Mean Volume Mean Hemoglobin Mean Hemoglobin



Concentration Red



Blood



Distribution



Cell



Width



-



Coefficient of Variation



2-4



Product Specification



Clone



Name



Abbreviation



CBC



CBC + DIFF



RDW-SD



*



*



Hematocrit



HCT



*



*



Platelet count



PLT



*



*



Mean Platelet Volume



MPV



*



*



Platelet



PDW



*



*



PCT



*



*



Red



Blood



Distribution



Cell



Width



-



Standard Deviation



PLT-Related(4



parameters)



Distribution



Width Plateletcrit



“*” means that parameters are tested under the mode; “/” means that parameters are not offered under the mode. Table 4



Histogram description



Name White



Blood



Abbreviation



Cell/



Basophils



Histogram



WBC/BASO



CBC



CBC + DIFF



/



*



Histogram



White Blood Cell Histogram



WBC Histogram



*



/



Red Blood Cell Histogram



RBC Histogram



*



*



Platelet Histogram



PLT Histogram



*



*



CBC mode: corresponding histograms include WBC Histogram, RBC Histogram and PLT Histogram; CBC＋DIFF mode: corresponding histograms include WBC/BASO Histogram, RBC Histogram and PLT Histogram. Table 5 Name Differential Scattergram



Scattergram description Abbreviation Diff Scattergram



2-5



CBC



CBC + DIFF



/



*



Product Specification



2. Parameter unit and format Table 6



Parameter unit and format



Unit



Parameter Format WBC



Mon#



***.**



109/L



Bas#



***.**



103/uL



Eos#



****.*



102/uL



Neu#



***.**



/nL



ALY#



MCV



RDW-CV



HCT



Mon% Bas% Eos% Neu%



**.* .***



％ None



ALY%



**.**



1012/L



****



109/L



**.**



106/uL



****



103/uL



****



104/uL



***.*



104/uL



**.**



/pL



****



/nL



***



g/L



****



g/L



**.*



g/dL



***.*



g/dL



**.*



mmol/L



***.*



mmol/L



***.*



fL



***.*



um3



**.*



%



.***



None



**.*



%



.***



L/L



.***



None



PLT



MCHC



MCH



RDW-SD



MPV



None （ 10 PDW



Unit



LIC%



LIC#



HGB



Format



Lym%



Lym#



RBC



Parameter



**.*



PCT GSD）



***.*



pg



**.**



fmol



****



amol



***.*



fL



***.*



um3



**.*



fL



**.*



um3



.***



%



*.**



mL/L



Note: Fast setup function of the units in different country mentioned in table 8 is provided; users can set them by passwords. Customization functions are also offered. When there are many units to be selected, user can customize all the units by the password. The setup of some parameters unit are correlated.



2-6



Product Specification



Table 7



Units in different country



International SI Parameter WBC RBC HGB HCT MCV MCH MCHC PLT Lym% Lym# RDW-SD RDW-CV MPV PDW PCT



Format



***.** **.** *** .*** ***.* ***.* **** **** .*** ***.** ***.* .*** **.*



Unit × 109/L × 1012/L g/L fL pg g/L × 109/L × 109/L fL fL None



**.*



(10GSD)



*.**



mL/L



America Format



***.** **.** **.* **.* ***.* ***.* ***.* **** **.* ***.** ***.* **.* **.*



Parameter



Format



MPV



***.** **.** **.* .*** ***.* **** ***.* **** .*** ***.** ***.* .*** **.*



PDW



**.*



PCT



*.**



WBC RBC HGB HCT MCV MCH MCHC PLT Lym% Lym# RDW-SD RDW-CV



× 103/µ L × 106/µ L g/dL % fL pg g/dL × 103/µ L % × 103/µ L fL % fL None



**.*



(10GSD)



. ***



Holland



Unit



× 109/L × 1012/L mmol/L L/L fL amol mmol/L × 109/L × 109/L fL fL None (10GSD) mL/L



Format



***.** **.** **.* .*** ***.* ***.* ***.* **** **.* ***.** ***.* **.* **.* **.* *.**



2-7



Format



***.** **.** *** .*** ***.* ***.* **** **** .*** ***.** ***.* .*** **.*



Unit × 109/L × 1012/L g/dL fL pg g/dL × 109/L % × 109/L fL % fL None (10GSD) mL/L



Unit × 109/L × 1012/L g/L L/L fL pg g/L × 109/L × 109/L fL fL None



**.*



(10GSD)



. ***



% England



Unit



Canada



%



Domestic Format



Unit



***.** **.** *** **.* ***.* ***.* **** **** **.* ***.** ***.* **.* **.*



× 109/L



**.* . ***



× 1012/L g/L % fL pg g/L × 109/L % × 109/L fL % fL None (10GSD) %



Product Specification



2.13 Performance requirements 2.13.1.



Requirements of background Table 8



Background Requirements



Parameter



Background Requirements



WBC



≤ 0.3  109 / L



RBC



≤ 0.03 1012/ L



HGB



≤1g/L



HCT



≤ 0.5 %



≤ 10  109 / L PLT The background requirements are applicable to whole blood and predilute blood. Background verification: Run the diluent as samples for 3 times, take the maximum value as the background result.



2.13.2.



Requirements of Carryover



Carryover means the carryover extent of the low concentrated sample from the high concentrated sample. Verification method: Domestic: take high value samples within the range of table 12 (high value control centrifuged or specified high value linear control), test 3 times consecutively, the value are i1,i2 and i3; and then take low value samples within the range of table 12(the low control is diluent for 10 times)，test 3 times consecutively, the value are j1，j2，j3, calculate the carryover with the following formula, it shall meet the requirements of table 11. International: take high value samples within the range of table 12,mix them well and



test 3



times consecutively, the value are i1，i2，i3; take diluent as low value sample, test 3 times consecutively, the value are j1，j2，j3, calculate the carryover with the following formula, it shall meet the requirements of table 11.



2-8



Product Specification



Table 9 Carryover Parameter



Carryover



WBC



≤0.5％



RBC



≤0.5％



HGB



≤0.6％



HCT



≤0.5％



PLT



≤1.0％



Table 10 concentration range of test sample of the carryover Parameter



low value range



15.00×109/L



< 3.00×109/L



RBC



> 6.00×1012/L



< 2.00×1012/L



HGB



> 200 g/L



< 40 g/L



HCT



>54.0%



>



< 100×109/L



Reproducibility requirements



Verification method： Domestic: Take a sample within the following range, test for 10 times consecutively, and calculate the (CV，%) or (d) with the formula. International: Take a sample within the following range, test for 11 times consecutively, take to results of 2-11 results to calculate the (CV，%) or (d) with the formula.



in the formula：



s ---- standard deviation of the sample test; x ---- mean of the sample test;



xi



---- Test value of the sample;



d ---- Absolute deviation of the sample test value.



2-9



Product Specification



Table 11 Reproducibility requirements



Whole blood (CV / Parameter



Predilute (CV)



Test range



Absolute deviation d*)



WBC



4.00×109/L～15.00 109 / L



≤2.0％



≤4.0％



Neu%



50.0％～60.0％



±4.0(d)



±8.0(d)



Lym%



25.0％～35.0％



±3.0(d)



±6.0(d)



Mon%



5.0%～10.0％



±2.0(d)



±4.0(d)



Eos%



2.0％～5.0％



±1.5(d)



±2.5(d)



Bas%



0.5％～1.5％



±0.8(d)



±1.2(d)



RBC



3.50  1012 / L ~ 6.00  1012 / L



≤1.5%



≤3.0%



HGB



110 g/L ~ 180 g/L



≤1.5%



≤3.0%



MCV



70 fL～120 fL



≤1.0%



≤2.0%



PLT



150  109 / L ~ 500  109 / L



≤4.0%



≤8.0%



MPV



/



≤4.0%



≤8.0%



2.13.4.



Linearity requirements



Under whole blood and predilute mode, prepare samples of different concentration and test them in order, calculate the slope and intercept with linearity equation and gain the theory value, get the deviation between the theory value and test value, it shall meet the following requirements.



2-10



Product Specification



Table 12 Parameter WBC



Linearity requirements



Linearity range



Whole Blood Mode*



Predilute Mode



～



±0.30×109/L or ±5％



±0.60×109/L or ±6％



～



±0.05×1012/L or ±5％



±0.10×1012/L or ±10％



0 g/L～250g/L



±2g/L or ±2％



±4g/L or ±4％



0×109/L～1000×109/L



±10×109/L or ±8％



±20×109/L or



0.00×109/L 99.99×109/L



RBC



0.00×1012/L 8.00×1012/L



HGB PLT



±16％



（RBC≤7.0） HCT



0%~67%



±2%(HCT) or



±3%



(error percentage)



2.13.5.



±4%(HCT)



or



±6%



(error percentage )



Display range of the main parameters Table 13



Linearity Requirements



Parameter



Linearity range



Display range



WBC



0.00～99.99×109/L



0～200.0×109/L



RBC



0.00～8.00×1012/L



0～18.00×1012/L



HGB



0～250g/L



0～300g/L



PLT



0～1000×109/L



0～2000×109/L



HCT



0~67%



0%~80%



2-11



Product Specification



2.13.6.



Correlation requirements of the compare device



Correlation requirements to the compare device Select a high end 5-diff analyzer to perform correlation evaluation. The compare analyzer and the BC-5300 shall be calibrated before the correlation evaluation and count the regression equation. In the statistical analysis, pick out the samples of which the accuracy will be influenced by the principle, such as microcytes, existed nucleated red blood cell and so on. In the statistical regression equation: Y ＝ aX + b; count the correlation coefficient r. Table 14



Correlation requirements of the whole blood count Parameter



r



WBC



≥ 0.99



RBC



≥ 0.99



HGB



≥ 0.98



MCV



≥ 0.98



PLT



≥ 0.95



Correlation analysis and regression calculation：



Correlation factor n is sample quantity Regression equation:



Y=aX+b，meanwhile:



n 2   ( Xij  X )(Yij  Y ) i 1 j 1 a n 2 2   ( Xij  X ) i 1 j 1



b  Y  a X ; n is sample quantity



2-12



Product Specification



2.13.7.



Correlation and accuracy requirements of the WBC differential parameters



Correlation requirements Select 100 normal samples and 100 abnormal sample to perform correlation test with CLSI reference method (H20, microscope method), take the mean and analyzer results to perform correlation analysis.



In the equation of linear regression, pick out the sample whose accuracy is restricted by the principle. In equation of linear regression: Y ＝ aX + b; calculate the correlation coefficient r, which shall meet the following requirements. Calibrate the analyzer before performing the correlation test. Table 15



correlation requirements of the whole blood differential



Parameter



correlation coefficient r to the manually differential



Neutrophils (Neu%）



≥0.90



Lymphocytes (Lym%)



≥0.90



monocyte (Mon%)



≥0.75



Eosinophils (Eos%)



≥0.80



Basophils (Bas%)



≥0.50



2.13.8.



Accuracy requirements



Select 20 samples tested with manual differentiate correlation at random,using the 99% trustable range calculation method to gain the trastable range of manual differentiate range. Compare the mean of results tested by the device with the trustable range,within the range of ≥99% of the trustable range lower limit or≤99% of the upeer limint are judged as qualified, those who are out of the range are judeged as unqualified. 1. Calculating standard deviation Equation: SEp＝



pq n



In the equation, n=200; p= mean obtained with the reference method; q=100-p; when freedom is 199, the t distribution factor of 99％ credibility limit =2.57. 2. Calculating credibility range The 99％ credibility range of a parameter rate: p±2.57×SEp. 3. Requirement The Lym%, Neu%, Mon%, Eos% and Bas% results tested by the analyzer must be within the 99％ credibility range of the results tested by the reference method.



2-13



Product Specification



2.13.9.



Identification capability of the abnormal samples



Microscopic Exam. Positive: the WBC differentiate are out of the normal reference range, there are special particles, NRBCs, abnormal morphology and abnormal growth and so on. Analyzer positive: the differentiate results are out of the reference range, there are histogram flag. Table 16



Definition of the abnormal samples Analyzer result



Microscopic exam result positive



positive TP (True Positive)



FN （false negative）



negative



Negative



FP (false positive）



TN (True Negative）



false positive flagging rate ＝ FP /(TN + FP)*100% false negative flagging rate ＝ FN /(FN + TP)*100% Capability requirements to identify the abnormal samples: analyze the differentiate results of the analyzer and microscope exam. results,, false negative < 15%; false positive < 20%。 The verification method will be described in details in the clinical verification plan.



2-14



3 3.1



Software System



Overview



The software system is consisted of the analyzer software and the PC operation software IPU. The analyzer software runs in the analyzer CF card, the operation software IPU runs in the Windows 7 Home Basic*32, Windows 7 Ultimate*32, Windows 7 Ultimate*64, Windows 8 Professional*32, Windows 8 Professional*64, Windows 8 Standard*32 and Windows 8 Standard*64 systems. The analyzer software analyzes sequences, collects and reads data; while the IPU saves, displays and prints results, displays analysis and QC data, and realizes data management, parameter setup and communication.



3.2



Password Function



There are 3 levels of passwords, general user, administrator and service engineer.



The



administrator can access all functions of the general user, and the service engineer can access all functions of the administrator. User name and password of the IPU:



3.3



Level



User name



Password



Service engineer



service



Se s700



Analyzer Software Upgrade



The installation & upgrade package shall be decompressed first. The package contains IPU installation package, analyzer upgrade package and installation & upgrade instructions. 1.Upgrade package Decompress the upgrade package, you will have:



Figure 3-1 Analyzer software upgrade package The installation packages of open vial and closed tube models are consolidated into one. 2.Upgrade procedure Start the upgrade tool:



3-1



Software System



Figure 3-2 Analyzer upgrade software menu Select "Analyzer Upgrade"



Figure 3-3 Analyzer upgrade confirmation screen Logon: only user of service access level or above may perform analyzer upgrade.



3-2



Software System



Figure 3-4 Analyzer upgrade software logon screen Select upgrade file: the upgrade directory



Figure 3-5 Select upgrade file After uploading, the upgrade process starts. If the kernel is upgraded, the above steps shall be repeated to complete upgrade. Kernel upgrade done. Repeat the above steps to upgrade again. When the process completes, restart the analyzer to complete upgrade.



Figure 3-6 Upgrade done 



Upgrade duration



3-3



Software System



Complete upgrade of the analyzer software requires 5～8 minutes. Note: 1) Do not disconnect power of the analyzer during the upgrade process, even if the process bar stays still for a while, or the upgrade may fail or the analyzer cannot be started. 2) Close the IPU before upgrade. The IPU shall be closed during analyzer upgrade process. 3) Power off the analyzer when prompt message instructs you so. Start up the analyzer 2 minutes later after the shutdown to continue with the upgrade.



4) If the upgrade fails, repeat the upgrade procedure again. 5) Ensure the completeness of the upgrade package, do not modify any file in the package. 6) Keep anti-virus software and fire wall closed throughout the upgrade process.



3.Handling upgrade failure Upgrade failed and insufficient disk space is reported, check the disk space. If the upgrade fails, repeat the upgrade procedure again. Ensure the completeness of the upgrade package, do not modify any file in the package.



3.4 Software Installation and Upgrade 3.4.1.



PC Configuration Hardware configuration



Software configuration



CPU: E3300



Operation system:



Memory: 2GB



Windows 7 and the versions above are



Hard disk: 320GB



recommended



CD-ROM: DVD-RW Network card: dual network card (1 integrated



Database: SQLite



card, and 1 independent card)



3.4.2.



Hard disk partition



Recommended hard disk partition:



Disk C: 40G system disk for installation of operation system and IPU Disk D: 200G data disk store IPU data and backup data Disk E: 80G file disk store other files



3.4.3.



IPU installation procedure



1. Open the installation disk, right click the file setup.exe, and select "Run as administrator" to start installation.



3-4



Software System



Figure 3-7 Run installation program 2. The "User Account Control" dialog box displays, select "Yes" to install the application. 3. The installation program checks system environment, such as operation system version and database, and then the following dialog box displays.



Figure 3-8 Database installation



3-5



Software System



4. If there are modules missing for installation of the IPU, install the modules, and restart the PC when the prompt message instructs so. 5. After all necessary modules are installed, the language selection screen displays, select the desired language of the IPU here.



Figure 3-9



Language selection dialog box



6. Click OK to enter the model selection dialog box, select the desired product model here (the following figure is given as an example, please select based on the actual product model).



Figure 3-10



Model selection dialog box



8. Click "Next “to enter the installation path selection dialog box. The installation program is normally installed in non-system disk. To make sure the "Analyzer IPU Software" can run properly, the residual space of the installation disk shall be more than 100M. 3-6



Software System



Figure 3-11 Installation path selection dialog box



9. Click "Next" to start the installation process of "Analyzer IPU Software". 10. Click "OK" to conclude the installation process. An shortcut icon will be created on the desktop and in the system menu.



Figure 3-12 Installation finished



Figure 3-13 Shortcut icon on the desktop



3-7



Software System



Figure 3-14 Shortcut icon in the system menu



3.4.4.



IPU upgrade



"Analyzer IPU Software" upgrade refers to installation of higher version software on the basis of the lower version. During the upgrade process, database installation directory and installation path selection dialog box will be not displayed. The functions to be completed are database structure upgrade, configuration file upgrade, print template upgrade. During the upgrade process, the print template upgrade dialog box will be displayed.



Figure 3-15 Upgrade the "Analyzer IPU Software"



3.4.5.



IPU repair



When the "Analyzer IPU Software" fails to run as normal due to file damage, double click the installation program, the "Repair and Upgrade" dialog box will display for you to repair or upgrade the software.



3-8



Software System



Figure 3-16 Modify, repair or delete This operation only affect program files.



3.5 3.5.1



Connection Setup of the IPU and Analyzer Analyzer Network Setup



Install the IPU, the default analyzer IP is 10.0.0.7. To modify analyzer IP, click "Setup - Advanced" to enter the following screen and input the value of each field.



Figure 3-17 IP address setup



3-9



Software System



Click "Apply". After restart the analyzer, the IP address will be refreshed. Connection status



Start the IPU and check the connection status icon



on the top right; flickering blue



suggests the connection is alright.



Figure 3-18 Connection status icon



3.6 LIS Setup and Connection 3.6.1 LIS communication setup The communication function supports unidirectional and bidirectional transmission of analyzer data to LIS (HIS). The communication setup is done on the IPU. Scattergrams and histograms can be transmitted in both binary and bitmap modes. Network port communication is supported. Connection to LIS as client end or server is supported. There are dynamic graphs or progress bars indicating communication process. To ensure data safety during transmission, exiting from the IPU software is not allowed. If you try to exit from the IPU, the dialog box "Transmitting, please try again later...". The communication setup of the IPU is as follows.



3-10



Software System



Figure 3-19 LIS connection setup screen



NOTE 1.



Only support network port communication.



2.



If IPU as server is not selected, then the IPU serves as a client end.



3.



IP address: valid in the condition of IPU client end network port communication. When the IPU communicates as client end, fill in the IP address of LIS server; when the IPU communicates as server, the address is neglected.



4.



Port: valid in the condition of IPU network port communication When the IPU communicates as client end, fill in the LIS server port; when the IPU communicates as server, and fill in name of the monitoring port of the local PC.



5.



IPU as server: valid in the condition of network port communication; select this item, the IPU will communicate as TCP server, or it will communicate as TCP client end.



6.



Protocol type: select protocol and coding type, "HL7+UTF8" is supported by now.



3-11



Software System



7.



ACK synchronous communication: this option applies to HL7 protocol in the condition of network port communication, or this option will be neglected.



8.



ACK overtime: valid if ACK synchronous communication applies; it refers to the longest waiting interval of ACK message after the IPU sends analysis results.



9.



Bidirectional LIS/HIS communication: if this option is selected, the analyzer will search for sample information from LIS during analysis.



10. Auto Transmission: if this option is selected, sample results and L-J QC results with special sample ID will be auto transmitted to IPU. 11. Histogram/scattergram transmitted as bitmap: if this option is not selected, the bitmap data of histogram/scattergram transmitted is consistent with the screen display; if it is selected, the bitmap data of histogram/scattergram transmitted is consistent with the print output, with white background and the histogram only has its profile. 12. L-J QC results transmitted in the format of sample results: if this option is selected, L-J QC results will be transmitted in the format of sample results (for both auto transmission and manual transmission); if it is not selected, L-J QC results will be transmitted in the format of QC message. 13. Histogram transmission mode: a.



Not transmit, sample results do not include histogram data



b.



Bitmap, sample results include histogram bitmap data



c.



Data, sample results include binary raw data of the histogram.



14. Scattergram transmission mode: a.



Not transmit, sample results do not include scattergram data



b.



Bitmap, sample results include scattergram bitmap data



c.



Data, sample results include binary raw data of the scattergram.



15. Version a.



Default version is 1.0; it supports LIS communication of the former version.



b.



If version 1.1 is selected, the transmitted contents will include new flags like WBC system abnormal, DIFF system abnormal, RBC system abnormal, aspiration abnormal, system abnormal and RBC clump.



3-12



Software System



3.6.2 Unidirectional LIS communication Function overview



1.



Auto transmission of normal samples



When IPU receives analysis results of normal samples, and auto transmission is on, the results will be auto transmitted to LIS. If transmission succeeded, the samples will be marked as transmitted samples in the review and report screen; if failed, prompt message will be given. 2.



Auto transmission of QC samples a.



When IPU receives analysis results of QC samples, and auto transmission is on, the results will be auto transmitted to LIS. If transmission failed, prompt message will be given.



b.



If "L-J QC results transmitted in the format of sample results" is selected, the L-J QC results will be encoded as normal sample information; if it is not selected, the L-J QC results will be encoded QC information.



c. 3.



Only L-J QC sample with special sample ID will be auto transmitted.



Batch transmission of samples



Batch transmission of normal sample results can be initiated from the review and report screen. If transmission succeeded, the sample results will be marked as transmitted. If transmission ACK error occurs, prompt message will be given; if network connection breaks off, prompt message will be given and the batching transmission will be terminated. 4.



Batch transmission of QC samples



Batch transmission of QC sample results can be initiated from the QC screen. If transmission ACK error occurs, prompt message will be given; if network connection breaks off, prompt message will be given and the batching transmission will be terminated. 5.



QC sample transmission parameters a.



The original value and display value of X-R, X Mean QC samples will be transmitted.



b. 6.



For X-B QC, only the display value will be transmitted.



Batch transmission of samples in the review screen Select samples in the review screen and click the Transmit button to transmit the selected samples.



3-13



Software System



Figure 3-20 Batch transmission of samples in review screen



7.



Click the Transmit button at the QC table screen, a dialog box displays, and then click "Start" to send data. If no data is selected or the date range is illegal, prompt message will be given.



3-14



Software System



Figure 3-21 Transmission of samples in QC table screen



3.6.3 Error indication 1.



IPU as server a.



LIS off indication: no LIS connection, the LIS icon shows connection breaks off.



b.



Error message for connection break-off during transmission: Connection breaks off! The LIS icon shows connection breaks off.



2.



IPU as client end a.



Connection establishment failed: LIS connection failed. The LIS icon shows connection breaks off.



b.



Error message for connection break-off during transmission: Connection breaks off! The LIS icon shows connection breaks off.



c.



ACK response failed: transmission is continued, and the message "ACK response failed!" is given. The message bubble will keep showing. The LIS icon shows connection is on.



3-15



Software System



3.6.4 Bidirectional LIS communication Worklist of bidirectional LIS On the worklist screen of bidirectional LIS, only the sample ID, loading mode, sample mode and sample position boxes can be edited. Inquiry will be sent to LIS when saving records, a progress bar will display at the bottom of the screen, and the sample list will be locked. When legal result are found, the progress bar will disappear, the list will be unlocked and the screen will be refreshed. If the inquiry times out, fails or the results are illegal, the saving operation will be canceled. Operation procedure: Click the Add worklist button to create a blank worklist. Enter the sample ID, switch the cursor or click Save directly. The IPU sends inquiry to LIS:



1.



If the server fails to get started, the message "Monitoring initiation failed, restart the IPU or modify the communication port and then try communication operation again." will be displayed.



2.



If the LIS function cannot be used at present, the message "No LIS/HIS connection available" will be displayed, and saving operation will fail.



3.



The communication module completes inquiry: a.



If communication error occurs or communication times out, the message "Communication times out!" will be displayed.



b.



If analysis mode is not obtained or illegal, the message "Invalid analysis mode" will be displayed. If loading mode or sample mode is obtained, the information will be displayed on the screen, and valid patient information will be displayed too.



c.



If patient information does not meet the requirement of the IPU data dictionary, or pass the screen restriction check, the message "Obtained info. invalid" will be displayed. If loading mode or sample mode is obtained, the information will be displayed on the screen, analysis mode and valid patient information will be displayed too.



d.



If information obtained is legal, and loading mode or sample mode is obtained, the information will be displayed on the screen, analysis mode and patient information will be displayed too.



NOTE The loading mode or sample mode editing can be done in the process of the inquiry, they can be modified any time in the saving process. Report pre-entry of bidirectional LIS The bidirectional LIS function does not affect report pre-entry. Users can pre-enter information, but when saving results, the information searched by the bidirectional LIS will be used.



3-16



Software System



Analysis of bidirectional LIS 1.



When bidirectional LIS is on, analysis with sample ID auto increment is not allowed.



2.



Bidirectional LIS affects open vial analysis not following the worklist and autoloading



analysis not following the worklist (following built-in barcode instead).



3.6.5 Frequently asked questions and the answers Q: Why does LIS connection fail? A: IPU sends inquiry to LIS, the message includes sample ID. LIS shall respond to the inquiry with results (including mode and patient information) within 10s; if the respond times out, prompt message will be given, and the saving operation or analysis flow will be terminated. Q: Why cannot the communication function be used? A: Invalid or no LIS communication setup; IPU is the server and no LIS connection. Q: How many kinds of bidirectional LIS inquiry failure are there? A:



1)



"No LIS/HIS connection available": users do not input legal connection settings, communication cannot be started.



2)



If the server fails to get started, the message "Monitoring initiation failed, restart the IPU or modify the communication port and then try communication operation again." will be displayed.



3)



"Measurement mode invalid": there is no measurement mode in the message received, or the measurement mode cannot be recognized.



4)



"Communication times out": response times out; the response is not consistent with the IPU data dictionary.



Q: Why does bidirectional LIS inquiry fail? A: invalid or abnormal data.



Data sent from LIS will be considered invalid in the following conditions: 1)



Character codes cannot be recognized.



2)



String length exceeds storage limit.



3)



Content is not the conventional type. For example: loading mode is not "OV", "AL" or "CT".



For patient information, if content of a field is invalid, then the field is invalid, other patient information fields are still valid.



Abnormal data refers to: 1)



Communication times out;



2)



Invalid data;



3)



Missing field;



4)



Not conforming to current mode.



3-17



Software System



Abnormal situations



Loading



Data entry rules of the analyzer



Missing field



Default mode will be used if users do not select mode



Invalid data



after starting the analyzer or before turning on



and



bidirectional LIS. If users do select mode, the



sample mode



selected mode will be used. If there are samples already analyzed, mode of the previous sample will be used. Missing field



Default mode will be used if users do not select mode



Invalid data



after starting the analyzer or before turning on bidirectional LIS. If users do select mode, the



Analysis mode selected mode will be used. If there are samples already analyzed, mode of the previous sample will be used. Patient



Missing



Blank



information



Invalid data



Blank



3-18



4



Main Parameters Description



4.1. Parameter source Test the parameters such as WBC, RBC, PLT and HGB of the blood and output 27 parameters, see the following table for details.



Clone



Name White



Blood



WBC



Cell count Basophil



Parameter source



Abbreviation



Gain the WBC by electric impulse number tested by the analyzer



Bas#



Bas# = Bas%*WBC



Bas%



Bas% = Baso particle numbers in the BAS



number Basophil percentage Neutrophil



area in the Baso channel *100%/WBC Neu#



Neu# = WBC*Neu%



Neu%



Neu% = particle numbers in the Neu area in



number Neutrophil



Leukon parameters



（



include 4 RUO parameters



） ，



percentage



the DIFF channel*100%/ all particle numbers except the ghost area in the Diff channel



Eosinophil



Eos#



Eos# = WBC*Eos%



Eos%



Eos% = particle numbers of the Eos area in the



number Eosinophil percentage



DIFF channel *100%/ all particle number except the ghost area in the DIFF channel



Lymphocyte



Lym#



Lym# = WBC*Lym%



Lym%



Lym% = particle numbers of the Lym area in



number Lymphocyte percentage



the DIFF channel *100%/ all particle number except the ghost area in the DIFF channel



Monocyte



Mon#



Mon# = WBC*Mon%



Mon%



Mon% = particle numbers of the Mon area in



number Monocyte percentage



the DIFF channel *100%/ all particle number except the ghost area in the DIFF channel



Abnormal



ALY#



ALY# = WBC*ALY%



ALY%



ALY% = particle numbers of the ALY area in



Lymphocyte number Abnormal Lymphocyte



the DIFF channel *100%/ all particle number



percentage



except the ghost area in the DIFF channel



4-1



Main Parameters Description



Clone



Name



Abbreviation



Large



Parameter source



LIC#



LIC# = WBC*LIC%



LIC%



LIC% = particle numbers of the LIC area in the



Immature Cell number Large Immature Cell



DIFF channel *100%/ all particle number



percentage



except the ghost area in the DIFF channel



Red Blood Cell



RBC



count



Gain the RBC by electric impulse number tested by the analyzer



Hemoglobin



HGB



Concentration



HGB=Constant*Ln(background permeate light intensity/ sample permeate light intensity)



Mean



MCV



Gain the MCV by the RBC histogram



MCH



MCH = HGB/RBC



Corpuscular Volume Mean Corpuscular



RBC-related(8 parameters)



Hemoglobin Mean



MCHC



MCHC = HGB*100/HCT



Corpuscular Hemoglobin Concentration Red Blood Cell



RDW-CV



Gain by the RBC histogram



RDW-SD



Gain by calculating the SD of Corpuscular



Distribution Width Coefficient



of



Variation Red Blood Cell Distribution Width



Volume



-



Standard Deviation



PLT-related (4 parameters)



Hematocrit



HCT



HCT = RBC*MCV/10



Platelet



PLT



Gain the PLT by electric impulse number tested by the analyzer



Mean Platelet



MPV



Calculated by the PLT histogram



PDW



Gain by the PLT histogram, which is 10GSD of



Volume Platelet Distribution



the PLT distribution



Width Plateletcrit



PCT



PCT = PLT*MPV/10000



4-2



Main Parameters Description



4.2. WBC Measurement 4.2.1. Flow Cytometry by Laser



Figure 4-1



WBC Measurement



After a predetermined volume of blood is aspirated and diluted by a certain amount of reagent, it is injected into the flow cell. Surrounded with sheath fluid (diluent), the blood cells pass through the center of the flow cell in a single column at a faster speed. When the blood cells suspended in the diluent pass through the flow cell, they are exposed to a laser beam. The intensity of scatter light reflects the blood cell size and intracellular density. The low-angle scattered light reflects cell size, and the high-angle scattered light reflects intracellular density (nucleus size and density). The optical detector receives this scatter light and converts it into electrical pulses. Pulse data collected can be used to draw a 2-dimensional distribution (scattergram). As shown in the following figure , X-axis represents the intracellular density and Y-axis the blood cell size. Various types of analysis data can then be obtained from the scattergrams.



4-3



Main Parameters Description



Figure 4-2



DIFF channel scattergram



By analyzing the DIFF channel scattergram, the analyzer presents the Lym%, Mon%, Eos% and Neu%.



4.2.2. Electrical Impedance Method WBCs/BASs are counted and sized by the Electrical Impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle, which in this case is a blood cell, suspended in a conductive diluent as it passes through an aperture of known dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an electrical pathway. As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated signals the number of particles that passed through the aperture. The amplitude of each pulse is proportional to the volume of each particle.



Figure 4-3



Electrical Impedance method



4-4



Main Parameters Description



Each pulse is amplified and compared to the internal reference voltage channel, which only accepts the pulses of a certain amplitude. If the pulse generated is above the WBC/BAS lower threshold, it is counted as a WBC/BAS. The analyzer presents the WBC/BAS histogram, whose x-coordinate represents the cell volume(fL) and y-coordinate represents the number of the cells.



4.2.3. WBC Parameters Based on the analysis of the DIFF channel scattergram and the Lym region, Neu region, Mon region and Eos region, the analyzer calculates the Lym%, Mon%, Eos% and Neu%. Having achieved the WBC, the analyzer proceeds to calculate Lym#, Neu#, Mon# and Eos# per the following equations while Bas# is obtained directly by the Electrical Impedance method and express them in 109/L.



4.3. HGB Measurement 4.3.1. Colorimetric Method HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the HGB bath where it is bubble mixed with a certain amount of lyse, which converts hemoglobin to a hemoglobin complex that is measurable at 525 nm. An LED is mounted on one side of the bath and emits a beam of monochromatic light, whose central wavelength is 525nm. The light passes through the sample and is then measured by an optical sensor that is mounted on the opposite side. The signal is then amplified and the voltage is measured and compared to the blank reference reading (readings taken when there is only diluent in the bath), and the HGB is measured and calculated in the analyzer automatically.



4.3.2. HGB The HGB is calculated per the following equation and expressed in g/L.



 Blank Phot ocurrent  HGB(g/L)  Constant  Ln    Sample Photocurr ent 



4.4. RBC/PLT Measurement 4.4.1. Electrical Impedance Method RBCs/PLTs are counted and sized by the Electrical Impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle, which in this case is a blood cell, suspended in a conductive diluent as it passes through an aperture of known dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an electrical pathway. As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated signals the number of particles that passed through the aperture. The amplitude of each pulse is proportional to the volume of each particle.



4-5



Main Parameters Description



4.5. Time counting method 4.5.1. Structure



1.Cancel the Volumetric Board and the 6 corresponding valves 2.Change the Vacuum chamber from 128mL to 200mL



4.5.2. Principle Volumetric method of the 53 series： The sample volume of each count (WBC 500uL, RBC 300uL) are measured by tube of fixed volume and initiated by the photocoupler. Volumetric tube is canceled of the 5300 series, the volume of the impedance channel are guaranteed by stable count time and stable aperture flow. Time counting method of the 5300 series: The volume of each count is guaranteed by the following formula: Measuring volume = Volumetric time x Aperture flow rate



4.6.Parameter Flag Message Information 4.6.1. Flag Message There are 32 flag messages, which include suspective flag and confirmative flag. Suspective flag indicates the flag is suspective while confirmative flag indicates the item is abnormal. See the following table for the indication and criteria of each flag.



4-6



Main Parameters Description



Channel



Flag Message



WBC abnormal



Property



Indication



Suspectable



The WBC may be



flag



incorrect



Criteria Calculate and compare special parameters Presence of abnormally



RBC Lyse



Suspectable



Possibility of RBC



distributed dots in



resistance



flag



lyse resistance



WBC sensitive region of the WBC scattergram



WBC



Suspectable



Abnormal distribution



Scattergram Abn.



flag



of WBC scattergram



WBC histogram



Suspectable



Abnormal distribution



Abn.



flag



of WBC histogram



The distribution of DIFF scattergram is abnormal The distribution of histogram is abnormal Presence of



Left Shift



Suspectable flag



excessive dots in Possibility of left shift



left shift sensitive region of the scattergram



Possible presence of



WBC



immature immature cells



Suspectable



granulocytes



flag



Presence of excessive dots in immature granulocyte sensitive region of the scattergram Abnormal



Abn./Atypical Lym



Suspectable



possibility of



scattergram/there



flag



Abn./Atypical Lym



are excessive dots in the Atypical Lym



leukocytosis Leukopenia Neutrophilia Neutropenia Lymphocytosis Lymphopenia



Confirmative flag Confirmative flag Confirmative flag Confirmative flag Confirmative flag Confirmative



4-7



WBC high WBC low Neu# high Neu# low Lym# high Lym# low



WBC > 18.00×10^9/L WBC < 2.50×10^9/L Neu# > 11.00×10^9/L Neu# < 1.00×10^9/L Lym# > 4.00×10^9/L Lym#
22 or RDW-SD > 64fL MCV < 70fL MCV > 113fL RBC > 6.5×10^12/L



Hypochromia



MCHC



interference



flag Macrocytosis



0.70×10^9/L



compare special



flag



Confirmative



Eos# >



or there is HGB



Abnormal distribution



flag



1.50×10^9/L



Calculate and



Suspectable



Confirmative



Mon# >



Hemoglobin abnormal



inaccurate



flag



Iron Deficiency



Baso# high



flag



Population



Abn.



Eos# high



RBC results possibly



Suspectable



Histogram



Mon# high



Suspectable



Dimorphic



RBC



RBC



0.80×10^9/L



Turbidity/HGB



RBC



Criteria



The distribution of PLT histogram is abnormal Calculate and compare special parameters



PLT high



PLT>600×10^9/L



Main Parameters Description



Channel



Flag Message Thrombopenia



Property



Indication



Confirmative



PLT low



Criteria PLT