I © 2011-2012 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issued Date is 2012-02. 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. , , are the trademarks, registered or otherwise, of Mindray in China and other countries. 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 changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor 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. the product is used in accordance with the instructions for use.
II 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 injury of human health. 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. This equipment must be operated by skilled/trained clinical professionals.
III 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.
IV Customer Service Department EC-Representative: Shanghai International Holding Corp. GmbH(Europe) Address: Eiffestraβe 80, Hamburg 20537, Germany Tel: 0049-40-2513175 Fax: 0049-40-255726 Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057,P.R.China Website: www.mindray.com E-mail Address: [email protected] Tel: +86 755 81888998 Fax: +86 755 26582680
1 Table of Contents 1 Using This Manual............................................................................................... 1-1 1.1 Introduction............................................................................................................ 1-1 1.2 Who Should Read This Manual............................................................................. 1-2 1.3 How to Find Information ........................................................................................ 1-3 1.4 Conventions Used in This Manual......................................................................... 1-4 1.5 Precautions, Limitations and Hazards................................................................... 1-5 1.6 Symbols................................................................................................................. 1-7 2 Understanding Your Analyzer ............................................................................ 2-1 2.1 Introduction............................................................................................................ 2-1 2.2 Parameters ............................................................................................................ 2-2 2.3 Hardware ............................................................................................................... 2-5 2.3.1 Overview .................................................................................................. 2-5 2.3.2 Modules and Components ....................................................................... 2-6 2.3.3 External Equipment................................................................................ 2-14 2.4 User Interface ...................................................................................................... 2-15 2.4.1 Of the SPU ............................................................................................. 2-15 2.4.2 Of the DMU ............................................................................................ 2-18 2.5 Software Operation.............................................................................................. 2-20 2.5.1 Of the SPU ............................................................................................. 2-20 2.5.2 Of the DMU ............................................................................................ 2-22 2.6 Help .....................................................................................................................2-30 2.7 Reagents, Controls and Calibrators ....................................................................2-31 2.7.1 Reagent.................................................................................................. 2-31 2.7.2 Controls and Calibrators ........................................................................ 2-34 3 Understanding the System Principles............................................................... 3-1 3.1 Introduction............................................................................................................ 3-1 3.2 WBC Measurement ............................................................................................... 3-2 3.2.1 SF CUBE Cell Analysis Technology......................................................... 3-2 3.2.2 Derivation of WBC-Related Parameters .................................................. 3-4 3.2.3 Derivation of NRBC Parameters .............................................................. 3-5 3.3 HGB Measurement................................................................................................ 3-6 3.3.1 Colorimetric Method ................................................................................. 3-6 3.3.2 HGB.......................................................................................................... 3-6 3.4 RBC/PLT Measurement......................................................................................... 3-7 3.4.1 Sheath Fluid Impedance Method ............................................................. 3-7 3.4.2 Derivation of RBC-Related Parameters ................................................... 3-7 3.4.3 Derivation of Reticulocyte-Related Parameters....................................... 3-8 3.4.4 Derivation of PLT-Related Parameters..................................................... 3-9 3.5 Wash.................................................................................................................... 3-11
Table of Contents 2 4 Installing Your Analyzer...................................................................................... 4-1 4.1 Introduction............................................................................................................ 4-1 4.2 Installation Requirements ...................................................................................... 4-2 4.2.1 Space Requirements................................................................................ 4-2 4.2.2 Power Requirements................................................................................ 4-3 4.2.3 General Environment ............................................................................... 4-4 4.2.4 Fuse Requirement.................................................................................... 4-4 4.2.5 Transportation and Installation................................................................. 4-4 4.3 Connecting the Analyzer System .......................................................................... 4-6 4.3.1 Pneumatic unit.......................................................................................... 4-6 4.3.2 Reagents .................................................................................................. 4-7 4.3.3 Optional Equipment.................................................................................. 4-9 5 Customizing the Analyzer Software .................................................................. 5-1 5.1 Introduction............................................................................................................ 5-1 5.2 Setting up the SPU................................................................................................ 5-2 5.2.1 Date Setup ("Menu" > "Setup" > "Date").................................................. 5-2 5.2.2 Auxiliary Setup ("Menu" > "Setup" > "Auxiliary Setup") ........................... 5-2 5.2.3 Reagent Setup ("Menu" > "Setup" > "Reagent")...................................... 5-4 5.2.4 Maintenance Setup (Administrator) ("Menu" > "Setup" > "Maintenance")5-5 5.2.5 Autoloader Setup (Administrator) ("Menu" > "Setup" > "Autoloader") ..... 5-6 5.2.6 Barcode Setup (Administrator) ("Menu" > "Setup" > "Barcode") ............. 5-7 5.2.7 Communication Setup (Administrator) ("Menu" > "Setup" > "Communication")................................................................................................... 5-8 5.2.8 Gain Setup (Administrator) ("Menu" > "Setup" > "Gain Setup")............... 5-9 5.2.9 Algorithm Setup (Administrator) ("Menu" > "Setup" > "Alg").................... 5-9 5.3 Setting up the DMU ............................................................................................. 5-11 5.3.1 General Setup ("Setup" > "General Setup")........................................... 5-12 5.3.2 Para. Setup (Administrator) ("Setup" > "Para. Setup") .......................... 5-22 5.3.3 Access Setup ("Setup" > "Access Setup") ............................................. 5-25 5.3.4 Data Dictionary ("Setup" > "Data Dictionary")........................................ 5-30 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") ............................... 5-32 5.3.6 Ref. Ranges (Administrator) ("Setup" > "Reference Ranges") .............. 5-32 5.3.7 Reexam Rules (Administrator) ("Setup" > "Reexam Rules ") ................ 5-34 5.3.8 Flag Setup ("Setup" > "Flag Setup") ...................................................... 5-39 5.3.9 Screen Display ("Setup" > "Screen Display ")........................................ 5-40 6 Operating Your Analyzer..................................................................................... 6-1 6.1 Introduction............................................................................................................ 6-1 6.2 Initial Checks ......................................................................................................... 6-2 6.3 Startup ................................................................................................................... 6-4 6.4 Daily Quality Control.............................................................................................. 6-9 6.5 Entering the “Count” Screen................................................................................ 6-10 6.6 Preparing Samples .............................................................................................. 6-12
Table of Contents 3 6.6.1 Whole blood samples............................................................................. 6-13 6.6.2 Prediluted samples................................................................................. 6-13 6.7 Sample Analysis in the OV Mode ........................................................................ 6-17 6.7.1 Selecting work mode.............................................................................. 6-17 6.7.2 Entering Worklist Information ................................................................. 6-19 6.7.3 Sample Analysis Procedure ................................................................... 6-22 6.7.4 Special Functions ................................................................................... 6-25 6.8 Sample Analysis in the Autoloading Mode .......................................................... 6-29 6.8.1 Enter Worklist Information...................................................................... 6-29 6.8.2 Sample Analysis Procedure ................................................................... 6-32 6.8.3 Special Functions ................................................................................... 6-44 6.8.4 Barcode Labels ...................................................................................... 6-47 6.9 Working with the Worklist .................................................................................... 6-49 6.9.1 Introduction............................................................................................. 6-49 6.9.2 Operations.............................................................................................. 6-49 6.10 Standby................................................................................................................6-53 6.11 Shutdown............................................................................................................. 6-54 7 Reviewing Sample Results................................................................................. 7-1 7.1 Introduction............................................................................................................ 7-1 7.2 Reviewing Sample Results from SPU ................................................................... 7-2 7.2.1 Table Review ("Menu" > "Table Review".................................................. 7-2 7.2.2 Graph Review........................................................................................... 7-8 7.3 Reviewing Sample Results from DMU ................................................................ 7-11 7.3.1 Introduction to the Screen...................................................................... 7-11 7.3.2 Button Functions .................................................................................... 7-17 7.3.3 Right-Click Menu Functions ................................................................... 7-28 7.3.4 History Review ....................................................................................... 7-32 7.4 Report.................................................................................................................. 7-34 7.4.1 Introduction of the Screen...................................................................... 7-34 7.4.2 Button Functions .................................................................................... 7-39 7.4.3 Right-Click Menu Functions ................................................................... 7-46 7.5 Statistics............................................................................................................... 7-52 7.5.1 Workload Summary（"Statistics" > "Workload Summary"） ................. 7-52 7.5.2 Summary of Positive Samples ............................................................... 7-53 7.5.3 General Summary .................................................................................. 7-53 7.5.4 Print Summary........................................................................................ 7-54 8 Using the QC Programs...................................................................................... 8-1 8.1 Introduction............................................................................................................ 8-1 8.2 L-J QC Program .................................................................................................... 8-2 8.2.1 QC Setup (Administrator)......................................................................... 8-2 8.2.2 L-J QC Run ............................................................................................ 8-11 8.2.3 Review L-J QC Results .......................................................................... 8-23
Table of Contents 4 8.3 X-B QC Program ................................................................................................. 8-41 8.3.1 Introduction to X-B QC Program ............................................................ 8-41 8.3.2 QC Setup (Administrator)....................................................................... 8-41 8.3.3 Running Controls.................................................................................... 8-46 8.3.4 Reviewing X-B QC results...................................................................... 8-46 8.4 X Mean QC Program...........................................................................................8-54 8.4.1 QC Setup (Administrator)....................................................................... 8-54 8.4.2 Running Controls.................................................................................... 8-61 8.4.3 Reviewing X mean QC results ............................................................... 8-68 8.5 X Mean R QC Program ....................................................................................... 8-80 8.5.1 QC Setup (Administrator)....................................................................... 8-80 8.5.2 Running Controls.................................................................................... 8-82 8.5.3 Reviewing X mean R QC results............................................................ 8-89 8.6 X-M QC Program............................................................................................... 8-101 8.6.1 X-M QC principle.................................................................................. 8-101 8.6.2 QC Setup (Administrator)..................................................................... 8-101 8.6.3 Running Controls.................................................................................. 8-105 8.6.4 Reviewing X-M QC results ................................................................... 8-105 9 Calibrating Your Analyzer................................................................................... 9-1 9.1 Introduction............................................................................................................ 9-1 9.2 When to Calibrate.................................................................................................. 9-2 9.3 How to Calibrate .................................................................................................... 9-3 9.3.1 Preparation............................................................................................... 9-3 9.3.2 Manual Calibration ("Menu" > "Calibration" > "Manual").......................... 9-6 9.3.3 Calibration with Calibrator (Administrator) ("Menu" > "Calibration" > "Calibrator") ............................................................................................................9-8 9.3.4 Calibration with Fresh Blood (Administrator) ("Menu" > "Calibration" > "Fresh blood").......................................................................................................9-12 9.3.5 Verifying calibration factors .................................................................... 9-17 9.4 Calibration History ("Menu" > "Calibration" > "History") ...................................... 9-18 9.5 Touch Screen Calibration ("Menu" > "Calibration" > "Touch Screen") ................ 9-19 10 Servicing Your Analyzer.................................................................................... 10-1 10.1 Introduction.......................................................................................................... 10-1 10.2 Reagent Management......................................................................................... 10-2 10.3 Maintaining Your Analyzer Using the Service Program....................................... 10-3 10.3.1 When and Why ............................................................................... 10-3 10.3.2 Replacing Reagent ("Menu" > "Service" > "Reagent" > "Replace Reagent") 10-3 10.3.3 Reagent Priming ("Menu" > "Service" > "Reagent" > "Reagent priming") 10-5 10.3.4 Cleaning ("Menu" > "Service" > "Cleaning")................................... 10-7 10.3.5 Maintenance ("Menu" > "Service" > "Maintenance")...................... 10-8
Table of Contents 5 10.3.6 Servicing the Fluidics ("Menu" > "Service" > "Fluidics")............... 10-10 10.4 Checking the Analyzer Status Using the Status Program ................................. 10-11 10.4.1 Statistics ("Menu" > "Status" > "Statistics")................................... 10-11 10.4.2 Temp.&Pressure ("Menu" > "Status" > "Temp.&Pressure").......... 10-12 10.4.3 Version Info. ("Menu" > "Status" > "Version Info.") ....................... 10-13 10.5 Viewing History Logs ......................................................................................... 10-14 10.5.1 Viewing Logs ................................................................................ 10-14 10.5.2 Exporting Logs (Administrator)..................................................... 10-15 10.6 Adjusting Pressure and Vacuum ....................................................................... 10-16 10.6.1 Introduction................................................................................... 10-16 10.6.2 Adjusting Pressure and Vacuum .................................................. 10-17 10.7 Manual Cleaning................................................................................................ 10-22 10.7.1 When and Why ............................................................................. 10-22 10.7.2 Opening and Closing the Front Cover.......................................... 10-22 10.7.3 Cleaning the Waste Collecting Trays............................................ 10-23 10.7.4 Cleaning the SRV ......................................................................... 10-30 10.7.5 Cleaning the Probe Wipe of the Open-Vial Module...................... 10-36 10.7.6 Sterilizing the Cover of the Analyzer............................................. 10-39 10.8 Replacing Containers or Components .............................................................. 10-40 10.8.1 When to Replace .......................................................................... 10-40 10.8.2 Replacing the Reagent Containers............................................... 10-40 10.8.3 Replacing the Waste Container.................................................... 10-44 10.8.4 Replacing the Sample Probe of the Autoloading Module............. 10-45 10.8.5 Replacing the Tube Clamp Assembly........................................... 10-51 10.8.6 Replacing the Filter....................................................................... 10-53 11 Troubleshooting ................................................................................................ 11-1 11.1 Introduction.......................................................................................................... 11-1 11.2 Error Information and Handling ........................................................................... 11-2 12 Customizing the Print Template....................................................................... 12-1 12.1 Introduction.......................................................................................................... 12-1 12.2 Entering the Print Template Screen..................................................................... 12-2 12.3 Editing the Template ............................................................................................ 12-4 12.3.1 Opening a Template........................................................................ 12-4 12.3.2 Editing the Template Property ........................................................ 12-4 12.3.3 Inserting Controls or Businesses.................................................... 12-4 12.3.4 Editing the Control(s)...................................................................... 12-5 12.4 Managing the Templates ..................................................................................... 12-7 12.4.1 Importing a Template ...................................................................... 12-7 12.4.2 Exporting a Template...................................................................... 12-8 12.4.3 Previewing a Template.................................................................... 12-9 12.4.4 Printing a Template......................................................................... 12-9 12.4.5 Deleting a Template........................................................................ 12-9
Table of Contents 6 12.5 Other Functions ................................................................................................. 12-10 12.5.1 Creating a New Business ............................................................. 12-10 12.5.2 Loading the Template Library ....................................................... 12-10 13 Appendices ......................................................................................................... A-1
1-1 1 Using This Manual 1.1 Introduction This chapter explains how to use your BC-6800 operation manual. This chapter explains how to use your operation manual, which is shipped with your Auto Hematology Analyzer and contains reference information about the BC-6800 and procedures for operating, troubleshooting and maintaining the analyzer. Read this manual carefully before operating your BC-6800 analyzer and operate your BC-6800 Auto Hematology Analyzer strictly as instructed in this manual.
Using This Manual 1-2 1.2 Who Should Read This Manual This manual contains information written for clinical laboratory professionals to: learn about the BC-6800 hardware and software. customize system settings. perform daily operating tasks. perform system maintenance and troubleshooting.
Using This Manual 1-3 1.3 How to Find Information This operation manual comprises 11 chapters and 4 appendices. Refer to the table below to find the information you need. If you want to … See … learn about the intended use and parameters of the BC-6800 Chapter 2 Understanding Your Analyzer Learn about the hardware, interface and software of the BC-6800 Chapter 2 Understanding Your Analyzer learn about how the BC-6800 works Chapter 3 Understanding the System Principles learn about the installation requirements of the BC-6800 Chapter 4 Installing Your Analyzer learn about how to define/adjust system settings Chapter 5 Customizing the Analyzer Software Learn about the process of sample collection and analysis Chapter 6 Operating Your Analyzer learn about how to use the BC-6800 to perform your daily operating tasks Chapter 6 Operating Your Analyzer review sample results Chapter 7 Reviewing Sample Results learn about how to use the quality control programs of the BC-6800 Chapter 8 Using the QC Programs learn about how to calibrate the BC-6800 Chapter 9 Calibrating Your Analyzer learn about how to maintain/service the BC-6800 Chapter 10 Servicing Your Analyzer Learn about how to solve the problems of the BC-6800 Chapter 11 Troubleshooting Learn about how to customizing the print template of the BC-6800 Chapter 12 Customizing the Print Template learn about the technical specifications of the BC-6800 Appendix B Specifications learn about the communication protocols of the BC-6800 Appendix C Communication
Using This Manual 1-4 1.4 Conventions Used in This Manual This manual uses certain typographical conventions to clarify meaning in the text: form meaning [××] all capital letters enclosed in [ ] indicate a key name (either on the pop-up keyboard or the external keyboard), such as [ENTER]. “××” bold letters included in " " indicate text you can find on the screen of the BC-6800 ×× italic letters indicate chapter titles, such as Chapter 1 Using This Manual. All illustrations in this manual are provided as examples only. They may not necessarily reflect your BC-6800 setup or data displayed.
Using This Manual 1-5 1.5 Precautions, Limitations and Hazards The following symbols are used to indicate danger and alert information in this manual. Symbols Meaning read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition. WARNING read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury. CAUTION read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. NOTE read the statement below the symbol. The statement is alerting you to information that requires your attention. All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory. If leakage happens to the analyzer, the leaked liquid is potentially biohazardous. WARNING Please check the firmness of all the doors and covers before running the analyzer. Make sure all the safety measurements are adopted. Disabling any safety device or sensor is prohibited. Please take action to any alarm and problem indication immediately. Do not touch the moving parts. Contact Mindray or Mindray-authorized distributors in time if any damaged part is found... Be careful when opening/closing and removing/installing the doors, covers and boards of the analyzer.
Using This Manual 1-6 Discard the analyzer according to government regulations. CAUTION Please use the analyzer strictly as instructed by this manual. Make sure only Mindray-authorized software is installed on the computer. Please install the original edition software to prevent the computer from being infected by virus. Please adopt proper measurements to prevent the reagents from being polluted. It is recommended that you install anti-virus software on the computer and scan for viruses periodically.
Using This Manual 1-7 1.6 Symbols You will find the following symbols in this manual: Symbols Meaning read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition. WARNING read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury. CAUTION read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. NOTE read the statement below the symbol. The statement is alerting you to information that requires your attention. You may find the following symbols of the analyzer system: CAUTION During the daily use of the analyzer, especially the cleaning process, the operator shall ensure the intactness of the labels. Symbols Meaning CAUTION, CONSULT ACCOMPANYING DOCUMENTS. Note: suggesting the users consult to accompanying documents to get important safety information. BIOLOGICAL RISK CAUTION, RISK OF ELECTRIC SHOCK WARNING, LASER BEAM
Using This Manual 1-8 CAUTION, HOT SURFACE PROTECTIVE EARTH (GROUND) ALTERNATING CURRENT FOR IN VITRO DIAGNOSTIC USE SERIAL NUMBER DATE OF MANUFACTURE MANUFACTURER THE FOLLOWING DEFINITION OF THE WEEE LABEL APPLIES TO EU MEMBER STATES ONLY: THE USE OF THIS SYMBOL INDICATES THAT THIS PRODUCT SHOULD NOT BE TREATED AS HOUSEHOLD WASTE. BY ENSURING THAT THIS PRODUCT IS DISPOSED OF CORRECTLY, YOU WILL HELP PREVENT BRINGING POTENTIAL NEGATIVE CONSEQUENCES TO THE ENVIRONMENT AND HUMAN HEALTH. FOR MORE DETAILED INFORMATION WITH REGARD TO RETURNING AND RECYCLING THIS PRODUCT, PLEASE CONSULT THE DISTRIBUTOR FROM WHOM YOU PURCHASED THE PRODUCT. THE DEVICE IS FULLY CONFORMANCE WITH THE COUNCIL DIRECTIVE CONCERNING IN VITRO DIAGNOSTIC MEDICAL DEVICES 98/79/EC. AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
Using This Manual 1-9 1 2 Figure 1-1 Back of the Analyzer 1 Connect only to a properly earth grounded outlet. To avoid electric shock, disconnect power cord prior to removing or replacing fuse. Replace fuse only with the type and rating specified. 2
Using This Manual 1-10 防护罩 1 前板 2 3 4 Figure 1-2 Stop Bar Position (Front Cover Open) 1 To avoid personal injury, after you lift the cover, be sure to fix it with the stop bar exactly as the above figure shows. 2 Mechanical risk may exist if the protective cover is removed. 3 4 Notes 1. Please slide the tube into the autoloader. If you fail to do so, replace the tube barcode. 2. Please make sure the tube cap is secured. Front Panel Shielding Cover
Using This Manual 1-11 3. Please make sure the unloading tray is not full and the detecting photocoupler is not covered, and then start analysis.
Using This Manual 1-12 Figure 1-3 Right of the Analyzer 1 Caution: laser radiation when open, please avoid the laser beam
Using This Manual 1-13 Figure 1-4 Front of the Pneumatic Unit 1
Using This Manual 1-14 Figure 1-5 Back of the Pneumatic Unit 1 To avoid damaging the pneumatic unit, do not block the vent at its back. 2 Connect only to a properly earth grounded outlet。 To avoid electric shock, disconnect power cord prior to removing or replacing fuse. Replace fuse only with the type and rating specified. To avoid the compressor being damaged, wait at least 1 minute before restarting the pneumatic unit. 3 To avoid damaging the pneumatic unit, do not block the vent at its back.
2-1 2 Understanding Your Analyzer 2.1 Introduction BC-6800 Auto Hematology Analyzer is a quantitative, automated hematology analyzer for In Vitro Diagnostic Use in clinical laboratories; it provides Complete Blood Count, Leukocyte 5-part Differential, Hemoglobin Concentration Measurement, Reticulocyte and Nucleated Red Blood Cell Measurement.
Understanding Your Analyzer 2-2 2.2 Parameters NOTE 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. BC-6800 provides: 33 basic parameters, 14 research parameters, 2 histograms, 6 scattergrams, 8 test panels. Basic Parameters White Blood Cell count WBC Basophil number Bas# Basophil percentage Bas% Neutrophil number Neu# Neutrophil percentage Neu% Eosinophil number Eos# Eosinophil percentage Eos% Lymphocyte number Lym# Lymphocyte percentage Lym% Monocyte number Mon# Monocyte percentage Mon% Reticulocyte percentage RET% Reticulocyte number RET# Immature Reticulocyte Fraction IRF Low Fluorescent Ratio LFR Middle Fluorescent Ratio MFR High Fluorescent Ratio HFR
Understanding Your Analyzer 2-3 Red Blood Cell count RBC Hemoglobin Concentration HGB Mean Corpuscular Volume MCV Mean Corpuscular Hemoglobin MCH Mean Corpuscular Hemoglobin Concentration MCHC Red Blood Cell Distribution Width - Coefficient of Variation RDW-CV Red Blood Cell Distribution Width - Standard Deviation RDW-SD Hematocrit HCT Nucleated Red Blood Cell count NRBC# Nucleated Red Blood Cell percentage NRBC% Platelet count PLT Mean Platelet Volume MPV Platelet Distribution Width PDW Plateletcrit PCT Platelet-Large Cell Ratio P-LCR Platelet- Large Cell Count P-LCC Research Use Only Parameters (RUO) High fluorescent Cell number HFC# High fluorescent Cell percentage HFC% Immature Granulocyte IMG# Immature Granulocyte percentage IMG% Optical Red Blood Cell count RBC-O Optical Platelet count PLT-O Platelet count- Impedance PLT-I Optical White Blood Cell count WBC-O White Blood Cell count -DIFF WBC-D White Blood Cell count –BASO WBC-B White Blood Cell count-NRBC WBC-N Platelet Distribution Width – Standard Deviation PDW-SD Infected Red Blood Cell count InR# Infected Red Blood Cell permillage InR‰
Understanding Your Analyzer 2-4 Histogram Red Blood Cell Histogram RBC Histogram Platelet Histogram PLT Histogram Scattergram Differential Scattergram DIFF Scattergram Basophils Scattergram BASO Scattergram Reticulocyte Scattergram RET Scattergram Optical Platelet Scattergram PLT-O Scattergram Reticulocyte－Extension Scattergram RET-EXT Scattergram Nucleated Red Blood Cell-Scattergram NRBC Scattergram Test Panel 1. CBC 2. CBC+ DIFF 3. CBC+DIFF+RETIC 4. CBC+RETIC 5. CBC+NRBC 6. CBC+DIFF+NRBC 7. CBC+DIFF+RET+NRBC 8. RET
Understanding Your Analyzer 2-5 2.3 Hardware 2.3.1 Overview The BC-6800 Auto Hematology Analyzer includes the Sample Processing Unit (SPU), Data Managing Unit (DMU), Pneumatic Unit (PU) and accessories. Component Function ①Sample Processing Unit (SPU) Processing patient samples and send original analysis results to the DMU ② Data Managing Unit (DMU) Managing data, such as editing worklist, reviewing results, generating reports, communicating with LIS, etc. ③ Pneumatic Unit (PU) Provide pressure and vacuum to the SPU ① ② ③
Understanding Your Analyzer 2-6 2.3.2 Modules and Components Figure 2-1 Front of the Analyzer 1 ---- Touch screen 2 --- Power indicator 3 ---- Sample probe 4 ---- Aspirate key 5 ---- Sample tube 6 ---- Tube rack 7 ---- Autoloader 8 ---- Fluorescent dye compartment door Touch screen The touch screen displays all alphanumeric and graphic data. You can use it to operate your analyzer
Understanding Your Analyzer 2-7 CAUTION Do not use anything sharp on the touch screen or strike on it. Clean the touch screen with clean and soft cloth, as well as neutral cleanser or ethanol rather than chemical solution, acid or alkali solution. Power indicator The power indicator tells you about the status of the analyzer including ready, running, error, standby and on/off, etc. Aspirate key You can press the aspirate key to start sample analysis or dispense diluent. Autoloader The autoloader is located in the front of the analyzer. You can use it to load tubes automatically.
Understanding Your Analyzer 2-8 Figure 2-2 Front of the analyzer (front cover open) 1 ---- Cover and touch screen module 2 ---- Cover stop bar 3 ---- Reaction bath module 4 ---- Manual sampling module 5 ---- HGB module 6 ---- Mix&pierce module 7 ---- Fluorescent reagent packages 8 ---- Fluorescent metering module 9 ---- RBC module
Understanding Your Analyzer 2-9 Figure 2-3 Back of the Analyzer 1 ---- AC input 2 ---- Pneumatic Unit Control Interface* 3 ---- Network interface** 4 ---- Waste sensor connector 5 ---- Waste outlet 6 ---- RET diluent inlet 7 ---- BASO lyse inlet 8 ---- Diluent inlet 9 ---- Pressure interface 10 ---- Vacuum interface 11 ---- HGB lyse inlet 12 ---- DIFF lyse inlet 13 ---- NRBC lyse inlet Pneumatic unit control interface You can use the pneumatic unit control interface to startup or shutdown the pneumatic unit.
Understanding Your Analyzer 2-10 Network interface You can use the network interface to connect the analyzer to the PC.
Understanding Your Analyzer 2-11 Figure 2-4 Right side of the analyzer (right door open) 1 ---- Optical system 2 ---- Sheath fluid heating valves 3 ---- Bath-related module 4 ---- Fluidic valve module 5 ---- USB interfaces 6 ---- Reagent heating module 7 ---- Sheath fluid heating module USB interface You can use the 4 USB interfaces to connect external equipments (like keyboard, printer, etc.) to the analyzer.
Understanding Your Analyzer 2-12 Figure 2-5 Left side of the analyzer (left door open, air valves presented) 1 ---- Boards integrating module 2 ---- Air valve module 3 ---- Pressure Filter 4 ---- Power module 5 ---- Power switch Power switch You can use the power switch to start up or shut down the analyzer CAUTION To avoid damage, do not turn on/off the power of the analyzer continually in a short time.
Understanding Your Analyzer 2-13 Figure 2-6 Front of the pneumatic unit 1 --- Relief valve 2 --- Operation indicator
Understanding Your Analyzer 2-14 Figure 2-7 Back of the pneumatic unit 1 --- Power switch 2 --- AC input 3 --- Pneumatic unit control interface 4 --- Vacuum interface 5 --- Pressure interface 2.3.3 External Equipment Keyboard (Optional) Mouse (Optional) Bar-code scanner (optional) NOTE Do not adjust the pneumatic relief valve. Contact Mindray Customer Service Department if necessary.
Understanding Your Analyzer 2-15 2.4 User Interface 2.4.1 Of the SPU System menu Menu Tree of the Analyzer Level 1 Level 2 Level 1 Level 2 Count / Cleaning Table / Maintenance QC / Reagent Manual Service Fluidics Calibrator (administrator) Statistics Calibration Fresh Blood (administrator) Status Temp.&Pressure System menu Utility buttons Auxiliary Information Client area Error message System time
Understanding Your Analyzer 2-16 History (administrator) Float Sensor (administrator) Touch Screen (administrator) Version Info. Date Function Config. Auxiliary Setup Logout / Reagent Shutdown / Maintenance (administrator) Autoloader (administrator) Barcode (administrator) Communication (administrator) Gain Setup (administrator) Setup Alg (administrator) Utility buttons Name Icon Function Count Tap to enter the "Count" screen Table Tap to enter the "Table" Review screen QC Tap to enter the "QC" screen Reagent Tap to enter the "Reagent" Setup screen Service Tap to enter the "Service" screen DILUENT When the mode is OV-PD, tap "DILUENT" to dispense diluent
Understanding Your Analyzer 2-17 Auxiliary information The area displays auxiliary information of the current screen, like the next sample information in the “Count” screen. Client area The area displays contents of each screen Auxiliary information The area displays related auxiliary information of the current screen: E.g. At the "Count" screen, it displays the ID and analysis mode of the next sample; at the "Graph Review" screen, it displays position of the current sample and total number of samples Error information area When error occurs, this area displays the error message. System time It displays the current system time
Understanding Your Analyzer 2-18 2.4.2 Of the DMU Title area Show the title of the analyzer and the current screen. Shortcut icon area Name Icon Function Logout Click to log out Print Screen Click to print the current screen Help Click to go to the software help screen About Click to check basic information of the software Menu area Hierarchy of the menu Level 1 Level 2 Level 1 Level 2 Report / Setup General Setup Sub-Menu Buttons Title Area Function Buttons Shortcut icon area User information area Client area Status icon area Menu Area
Understanding Your Analyzer 2-19 Review / Para. setup Worklist / Access Setup L-J Data Dictionary X-B Para. Unit X Mean Ref. Ranges X Mean R Reexam Rules QC X-M Flag Setup Workload Summary Screen Display Statistics Summary of Positive Samples Log / General Summary Shutdown/Exit There DMU only shows the Level 1 menus, and you can enter the Level2 screens by using the sub-menu buttons in the button area. Button area It displays the available sub-menu buttons and function buttons of the current screen. If there are both types of buttons, they are separated by a vertical line in this area. Client area The area displays contents of each screen. User information area The area displays the access level, user ID and username of the current user. Dynamic area It displays information like error messages. Status icons Including the printer status icon and the instrument status icon, indicating whether the printer is idle and whether the instrument is connected to the PC.
Understanding Your Analyzer 2-20 2.5 Software Operation 2.5.1 Of the SPU Pop-up keyboard Click any text box to activate the pop-up keyboard (full keyboard or numeric keyboard, depending on the contents to be entered into the text box), see the following figure. Click to close the pop-up keyboard.
Understanding Your Analyzer 2-21 Table You will see the table above on the "Review" screen. Click the buttons on the right and below the table to view information in the table. These buttons are: (previous page), (next page), (previous row), (next row), (leftmost page), (rightmost page), (left page), (right page), (left column), (right column). Besides, you can also view information in the table by pressing the buttons ([←], [→], [↑], [↓], [PgUp], [PgDn]) on the keyboard. Date Text box The following figure is a date text box, and you can edit date per the preset date format in the text box. The default ranges allowed are: Year [0, 9999]; Month [1, 12]; Date [1, 31]. You can shift the cursor in the text box by pressing [Tab] and [Shift]+[Tab]. Time Text box The following figure is a time text box, you can edit time in the text box, and the valid range is: [00:00, 23:59]. Check Box Click the check box, a "√" mark appears in the frame, indicating the option is chosen.
Understanding Your Analyzer 2-22 Click the option again, the “√” disappeared, it means the option is not chosen as shown below. 2.5.2 Of the DMU Please make sure you fully understand the meaning of the following operations or interfaces before you start operating the software of the PC. Move the pointer Move the pointer displayed on the interface by operating the mouse. CLICK Move the pointer to the desired content, left click the mouse then release. NOTE Repeat the operation if failed to choose the content; check the connection of the mouse if necessary. If the problem still exists, please contact Mindray or your local distributor immediately. Double click Move the pointer to the desired content, left click the mouse twice rapidly then release. NOTE Repeat the operation if failed to choose the content; check the connection of the mouse if necessary. If the problem still exists, please contact Mindray or your local distributor immediately. Right click Move the pointer to the desired content, right click the mouse then release.
Understanding Your Analyzer 2-23 NOTE Repeat the operation if failed to choose the content; check the connection of the mouse if necessary. If the problem still exists, please contact Mindray or your local distributor immediately. DRAG SCROLL BAR On some screens, the information can not be fully displayed in one page, then a scroll bar(horizontal/vertical) will appear. You can scroll the scroll bar in the following ways to check the rest of the information. A scroll bar is shown below: Click the "arrow button" on the scroll bar. Move the pointer to the slide bar, left click the mouse and hold, then scroll the bar at will. Click the blank area on the scroll bar. View indicating information The software provides the indicating information to the content displayed (e.g. buttons, titles, etc.)It will display automatically when the pointer is moved onto the certain area. Tab screen Tag screen displays one page of the multipage information. For example, click the "Main", "WBC" and "RBC" tabs on the "Review" screen, you can enter the corresponding screens to view information.
Understanding Your Analyzer 2-24 Button Common buttons After clicking the button, certain function will perform. For example, the system will print after clicking the "print" button as shown below. Arrow buttons of the combo box Click the button, a pull-down list of the combo box will appear as shown below. The options will be displayed in the combo list. Hide the pull-down list by click the arrow button again: Arrow button of the date text box The date text box is shown below: After clicking the arrow button on the date text box, a date box will pop up. Choose the year: click the displayed year twice, there will be several years listed for you to select. If the desired year is not displayed, click the year range displayed on top to go to the year range list. Choose the desired year range and then the year. Choose the month: Operation 1: click the arrow button on the both sides of the date box to switch and choose the desired month. Operation 2: click the displayed month, then click the desired month from the list appeared as shown below.
Understanding Your Analyzer 2-25 Choose the date: click the desired date. When the date box pops up, you can hide it by pressing the [Esc] on the keyboard. Radio button Click the single choice button, a mark appears in the circle, indicating the option is chosen. For example, click "Network Interface" in the figure below to communicate through network interface. NOTE Only one radio button can be chosen for one setting. Order adjusting buttons You can see the Order adjusting buttons on some screens with tables. You can adjust the order of items in the table by clicking the order adjustment button. These buttons are: (to the top), (move up), (move down) and (to the bottom). Check Box Click the check box, a "√" mark appears in the frame, indicating the option is chosen. Click the option again, the “√” disappeared, it means the option is not chosen as shown below.