Servicing Your Analyzer 10-36 CAUTION Once reagents spill on the surface of the analyzer, wipe them off with a damp cloth or tissue as soon as possible. 13. Run a blank count after startup. Be sure the results are within required ranges. 10.7.5 Cleaning the Probe Wipe of the Open-Vial Module 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. WARNING Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations. The sample probe and the SRV may contain biohazardous materials. Exercise caution to avoid direct contact with the probe and the SRV when working around them. 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. CAUTION After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer. When disassembling, cleaning and reassembling the probe wipe of the open-vial module, do not use too much force. Otherwise, the probe wipe may be damaged. 1. Shut down the analyzer, and wait several minutes after power-off.
Servicing Your Analyzer 10-37 2. Open the front cover. WARNING To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly. 3. Pull the probe wipe assembly down to the lowest position, and then remove it from the sample probe. 4. Separate the probe wipe from the probe wipe assembly. Disconnect the tubing from the probe wipe.
Servicing Your Analyzer 10-38 5. Wash the probe wipe with clean water, wipe it dry and install it back properly. Place the probe wipe assembly to the original position when the analyzer is turned off. CAUTION Disconnect the tubes by pinching the connecting ends, swaying them while pulling them outward. Do not use too much force while disconnecting the tubes. Otherwise, the probe wipe of the open vial sampling unit may be damaged. Make sure the sample probe is properly installed through the probe wipe and the probe wipe is at its original position. Otherwise the wipe may be stuck and unable to work properly. 6. Close the front cover. WARNING To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar. CAUTION To avoid damage to the components of the analyzer, close the front cover gently.
Servicing Your Analyzer 10-39 10.7.6 Sterilizing the Cover of the Analyzer The user shall perform daily cleaning and sterilization to the cover of the analyzer. Use the specified materials to sterilize the equipment only. For any damage to the instrument or other accidents caused by using materials other than specified, Mindray will not provide any warranty. Mindray does not claim the validity of the listed chemicals in infection control. For effective control of infection, please consult the Infection Prevention Department of the hospital or the epidemic professionals. The sterilization may damage the analyzer to some extent. It is recommended to perform sterilization only when necessary according to your laboratory protocol. Remember to clean the equipment before sterilizing. Recommended disinfectant: 70% ethanol, 70％ isopropyl alcohol and Cidex 2% Glutaral + Activator. Prohibited disinfectant: 3% hydrogen peroxide, Aerodesin 2000, Cidex OPA.
Servicing Your Analyzer 10-40 10.8 Replacing Containers or Components 10.8.1 When to Replace Procedure When to Replace Replacing the reagent containers As needed Replacing the waste container When the current waste container is full Replacing the sample probe of the autoloading module Sample probe is damaged Replacing the tube clamp assembly Tube dropping from the clamp Replacing the filter Pressure-related errors are reported, and the auto draining module cannot work properly 10.8.2 Replacing the Reagent Containers 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. WARNING Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations. 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.
Servicing Your Analyzer 10-41 CAUTION After replacing the reagent container, check the tubing connected to the cap assembly and make sure it is not bent over. Replacing the M-68DS DILUENT container 1. Get a new container of M-68DS DILUENT, open the cap, and put the container next to the one to be replaced. 2. Remove the supporting board under the cap of the old container. 3. Turn the cap of the old container counterclockwise, and then take out the cap assembly with caution. 4. Insert the pickup tube of the cap assembly vertically into the new container, and then turn the cap clockwise until it is secured. 5. Install the supporting board under the cap as instructed below. 6. Cap the old container with the cap of the new container and propose of the container properly. Replace the fluorescent dye bag 1. Open the fluorescent dye compartment door.
Servicing Your Analyzer 10-42 2. Get a new bag of fluorescent dye, open the cap and the aluminium film sealing the bag. 3. Take out the bag to be replaced along the direction of the supporting rack. 4. Turn the cap of the old bag counterclockwise, and then take out the cap assembly with caution.
Servicing Your Analyzer 10-43 5. Insert the pickup tube of the cap assembly vertically into the new container, and then turn the cap clockwise until it is secured. 6. Put the new bag back to the supporting rack, making sure the bag is securely accommodated. 7. Cap the old bag with the cap of the new bag and dispose of the bag properly.
Servicing Your Analyzer 10-44 WARNING While replacing the fluorescent dye bag, hold the upper corners of the bag or the part under the bag mouth (where the interior tube is located), in order not to extrude the reagent out. CAUTION While replacing the fluorescent dye bag, make sure the name on the bag label and that on the label of the exterior tubing of the cap assembly are the same. When you take out the pickup tube of the cap assembly from the fluorescent dye bag, if the tube is stuck, move it slightly and try to take it out again. Do not pull it violently. Do not insert the pickup tube of the cap assembly down to the bottom the fluorescent dye bag to ensure proper aspiration. Replacing other reagent (except M-68DS DILUENT and fluorescent dyes) containers 1. Get a new container of desired reagent, remove the cap and place it next to the one to be replaced. 2. Turn the cap counterclockwise and remove the cap assembly from the container with caution. 3. Insert the pickup tube of the cap assembly into the new container, and secure the cap by turning it clockwise. 4. Cap the old container with the cap of the new one, and then dispose of it properly. 10.8.3 Replacing the Waste Container 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.
Servicing Your Analyzer 10-45 WARNING Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations. Remove the waste container cap and replace the waste container only when the power indicator is not flickering, in order not to make the waste overflow from the container. 1. Get an empty waste container, remove the cap and place it next to the one to be replaced. 2. Turn the cap counterclockwise and remove the cap assembly from the container with caution. 3. Insert the pickup tube of the cap assembly into the new container, and secure the cap by turning it clockwise. 4. Cap the old container with the cap of the new one, and then dispose of the waste properly. 10.8.4 Replacing the Sample Probe of the Autoloading Module 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. WARNING Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations. The sample probe may contain biohazardous materials. Exercise caution to avoid direct contact with the probe when working around them. 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.
Servicing Your Analyzer 10-46 CAUTION After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer. NOTE To ensure that the analyzer functions normally, check the sample probe of the autoloading module periodically and replace it in time. 1. Shut down the analyzer, and wait several minutes after power-off. 2. Open the front cover. WARNING To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly. 3. Loosen the fixing screws to remove the protective cover of the autoloading piercing unit.
Servicing Your Analyzer 10-47 4. Disconnect all tubes connected to the probe and probe wipe. 5. Loosen the fixing nut at the end of the probe.
Servicing Your Analyzer 10-48 6. Remove the 2 fixing screws securing the fixing block.
Servicing Your Analyzer 10-49 7. Remove the fixing block, and then the sample probe.
Servicing Your Analyzer 10-50 8. Take a new sample probe from the accessory kit, insert it through the probe wipe, and install the fixing block to fix the new probe. 9. Reconnect the tubes to the probe and probe wipe properly, and install the protective cover.
Servicing Your Analyzer 10-51 10 . Close the front cover. WARNING To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar. CAUTION To avoid damage to the components of the analyzer, close the front cover gently. 10.8.5 Replacing the Tube Clamp Assembly CAUTION After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer. 1. Shut down the analyzer, and wait several minutes after power-off. 2. Open the front cover, and you can find the tube clamp assembly. WARNING To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly. 3. Loosen the fixing screws to remove the protective cover of the tube clamp assembly.
Servicing Your Analyzer 10-52 4. Remove the fixing screws securing the tube clamp assembly. 5. Install a new tube clamp assembly. NOTE Make sure the installed tube clamp assembly does not slant. 6. Install the protective cover.
Servicing Your Analyzer 10-53 7. Close the front cover. WARNING To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar. CAUTION To avoid damage to the components of the analyzer, close the front cover gently. 10.8.6 Replacing the Filter After a long period of running, the filter may be blocked by dust, which may cause pressure / vacuum error or malfunction of the auto drainage. In such case, contact Mindray Service Department or your local distributor to clean or replace the filter.
11-1 11 Troubleshooting 11.1 Introduction This chapter contains information that is helpful in locating and correcting problems that may occur during operation of your analyzer. NOTE This chapter is not a complete service manual and is limited to problems that are readily diagnosed and/or corrected by the user of the analyzer. If the recommended solution fails to solve the problem, contact Mindray or your local distributor.
Troubleshooting 11-2 11.2 Error Information and Handling During the operation, if error(s) is detected, the analyzer will beep and display the corresponding error message in the pop-up dialog box. You can see the error name(s) and the corresponding troubleshooting information in the pop-up dialog box. The error names are displayed in order. You can click the error name in the dialog box to select (highlight) it and check the corresponding troubleshooting information in the “Troubleshooting” list under the dialog box. The troubleshooting information of the first error will display (default). Follow the instructions in the dialog box to remove the error(s) The following functions are provided in the current dialog box. Removing Error Press the "Remove error" button, then the system will remove the error automatically if possible. If the error(s) still exists, you should follow the instructions of the troubleshooting to remove the error(s). Muting Press the “Mute” button to mute the alarm. Closing Error Dialog Box Click the “Close” button to close the “Error” dialog box, but the corresponding error message will display in the error message area. If you click the error message again, the “Error” dialog box will be re-opened.
12-1 12 Customizing the Print Template 12.1 Introduction You can modify the print template based on the default one provided by the software in order to customize the format of the report. After customizing and saving a template, you can select the newly customized one in the print setup. And then, the report will be printed in the customized template. Users of common level have no authority to customize report.
Customizing the Print Template 12-2 12.2 Entering the Print Template Screen Log in as an administrator, and then click "Menu" "Setup" "Print" to go to the print setup screen. 1. Click the “Customize” button to enter the “PrintTemplate” screen, and the following message box will pop up. 2. Enter the correct user name and password in the message box, and go to the print template screen shown as follows.
Customizing the Print Template 12-3 1 --- Main screen 2 --- Menu bar 3 --- Toolbar 4 --- Working area 5 --- Toolbar 6 --- Status bar 7 --- Property tab 8 --- Report tab
Customizing the Print Template 12-4 12.3 Editing the Template 12.3.1 Opening a Template You can open a template by one of the following ways: Click on the "Report" tab in the "ProjectProperty" area to display all existing templates in the current template library. Click one of the template names and the corresponding template will be displayed in the working area. Click "File" "Open" on the menu bar or the button on the toolbar, and then specify the directory and select the template file. Click "Open" to open the template. 12.3.2 Editing the Template Property After you open a template, the properties of this template will be displayed under the "Property" tab on the left of the screen. Click the cell to the right of the property name box to edit the property. If the cell is an edit box, modify the property directly; if the cell is a pull-down list, choose the desired value in the list. 12.3.3 Inserting Controls or Businesses Inserting a Control Click "Insert" on the menu bar and choose the control you want to insert; or select a control in the tool bar on the bottom left, and drag it to the desired place in the working area. You can click the button (line control) to draw a straight line or an oblique line in the working area. You can click the button (title control) to add a title in the working area. You can click the button (label control) to add the fixed text information in the working area. You can click the button (edit control) to add details associated with the print template and the changeable information in the working area. You can click the button (picture control) to arrange the location and size of the graph in the working area.
Customizing the Print Template 12-5 You can click the button (table control) to add a table in the working area. Inserting a Business A business is a set of controls which can be inserted in the template to facilitate the editing process. Do as follows to insert a business: 1. Click "Insert" on the menu bar and choose "Head", "Body" or "Tail". The following message box will pop up. 2. Select the desired business name in the pull-down list. Click the "Ok" button to close the message box and insert the selected business. 12.3.4 Editing the Control(s) You should select the control(s) you want to edit before start editing. Click on the control to select it. You can select multiple controls by one of the following ways: Press and hold the "Ctrl" key on the keyboard, and at the same time, click on the controls you want to select. Click on the template in the working area and drag the mouse to enclose the controls you want to select in the rectangular box displayed. Moving the Control(s) You can move the control(s) by one of the following ways: Select the control(s) you want to move. Left click and hold the mouse, and then move the control to the destination and release. Select the control(s) you want to move. Press and hold the "Ctrl" key, and move the control using the arrow keys on the keyboard. Aligning the Control(s) Select the control(s), and select the desired alignment options in the "Format" menu or the
Customizing the Print Template 12-6 corresponding button on the toolbar on the bottom left. Modifying the Size of a Control Select the control you want to edit, and then drag the borders to modify the size. Editing the Property of the Control(s) Select the control(s) you want to edit, and the properties will be displayed under the "Property" tab on the left of the screen. Click the cell to the right of the property name box to edit the property. If the cell is an edit box, modify the property directly; if the cell is a pull-down list, choose the desired value in the list.
Customizing the Print Template 12-7 12.4 Managing the Templates 12.4.1 Importing a Template When you enter the main screen, you can see all the imported templates under the "Report" tab in the "ProjectProperty" area. Do as follows to import a new template to the current template library: 1. On the menu bar, click "File" "Import", and the following message box will pop up. 2. Choose the import type and click "Ok". Then the following message box will pop up. 3. Select the template file you want to import and click "Open" to import the template into the current library. The name of the imported template will be displayed under the "Report" tab, shown as follows.
Customizing the Print Template 12-8 12.4.2 Exporting a Template 1. Click on the "Report" tab in the "ProjectProperty" area to display all the templates in the current template library. 2. Double click the template you want to export to open it in the working area. 3. On the menu bar, click "File" "Export", and the following message box will pop up.
Customizing the Print Template 12-9 4. Specify the directory you want to save the template and enter the file name. Click "Save" to save the template. 12.4.3 Previewing a Template Click "File" "Preview" on the menu bar or the button on the toolbar to preview the current template. 12.4.4 Printing a Template Click "File" "Print" on the menu bar or the button on the toolbar to print the current template. 12.4.5 Deleting a Template Click "File" "Delete" on the menu bar or the button on the toolbar to delete the current template.
Customizing the Print Template 12-10 12.5 Other Functions 12.5.1 Creating a New Business 1. Click "Business" "New" on the menu bar to open a blank template. 2. Insert the desired controls and modify their properties. 3. Click "Business" "Save" on the menu bar, and the following message box will pop up. Enter the information of the business in corresponding boxes and click "Ok" to save the business. 12.5.2 Loading the Template Library 1. Click "Setting" "LoadTemplateLib" on the menu bar, and the following message box will pop up. 2. Select the right machine model and click "Ok" to load the template library for this model. 3. When the loading is completed, all the templates in the loaded library will be displayed under the "Report" tab.
A-1 13 Appendices A Index A Analyzer, 2-1 B Background, B-4 Barcode Labels, 6-47 Bas# formula, 3-4 Bas% formula, 3-4 Blank Count, B-4 C Calibration, 9-1 Calibrator, 9-8 Fresh Blood, 9-12 Manual, 9-6 Carryover, B-6 Communication, C-1 Compatibility, B-5 Controls and Calibrators, 2-34 Correlation, B-6 D Data Managing Unit (DMU), 2-5 Display range, B-4 E EMC, B-8 Eos# formula, 3-5 Eos% formula, 3-4 External Equipment, 2-14 H HCT formula, 3-8 Help, 2-30 HFR formula, 3-9 HGB formula, 3-6 Histogram PLT Histogram, 2-4 RBC Histogram, 2-4 History Log, 10-14 I IFR formula, 3-9 Interfaces, B-8 L LFR formula, 3-8 Linearity Range, B-4 Lym# formula, 3-5 Lym% formula, 3-4
Index A-2 M Manual Cleaning, 10-22 MCH formula, 3-8 MCHC formula, 3-8 MCV formula, 3-7 MFR formula, 3-8 Mode Abbreviations, 6-17 Mon# formula, 3-5 Mon% formula, 3-4 MPV formula, 3-9 N Neu# formula, 3-5 Neu% formula, 3-4 NRBC# formula, 3-5 NRBC% formula, 3-5 P Pack-up, 10-10 Parameters Bas#, 2-2 Bas%, 2-2 Eos#, 2-2 Eos%, 2-2 HCT, 2-3 HFR, 2-2 HGB, 2-3 IRF, 2-2 LFR, 2-2 Lym#, 2-2 Lym%, 2-2 MCH, 2-3 MCHC, 2-3 MCV, 2-3 MFR, 2-2 Mon#, 2-2 Mon%, 2-2 MPV, 2-3 Neu#, 2-2 Neu%, 2-2 NRBC#, 2-3 NRBC%, 2-3 PCT, 2-3 PDW, 2-3 P-LCC, 2-3 P-LCR, 2-3 PLT, 2-3 RBC, 2-3 RDW-CV, 2-3 RDW-SD, 2-3 RET#, 2-2 RET%, 2-2 WBC, 2-2 PCT formula, 3-9 PDW formula, 3-9 P-LCC formula, 3-10 P-LCR formula, 3-9 PLT formula, 3-9 Pneumatic Unit (PU), 2-5 print template, 12-1 Q QC Program L-J QC, 8-2 X Mean QC, 8-54 X Mean R QC, 8-80 X-B QC, 8-41 X-M QC, 8-101
Index A-3 Quality Control, 8-1 R RBC formula, 3-7 RDW-CV formula, 3-8 RDW-SD formula, 3-8 Reagent M-68DR DILUENT, 2-31 M-68DS DILUENT, 2-31 M-68FD DYE, 2-32 M-68FN DYE, 2-33 M-68FR DYE, 2-32 M-68LB LYSE, 2-33 M-68LD LYSE, 2-32 M-68LH LYSE, 2-33 M-68LN LYSE, 2-32 PROBE CLEANSER, 2-33 Reproducibility, B-5 Research Use Only Parameters (RUO) IMG#, 2-3 IMG%, 2-3 PLT-I, 2-3 PLT-O, 2-3 RBC-O, 2-3 WBC-B, 2-3 WBC-D, 2-3 WBC-N, 2-3 WBC-O, 2-3 RET# formula, 3-8 RET% formula, 3-8 S Sample Processing Unit (SPU), 2-5 Scattergram BASO Scattergram, 2-4 DIFF Scattergram, 2-4 NRBC Scattergram, 2-4 PLT-O Scattergram, 2-4 RET Scattergram, 2-4 RET-EXT Scattergram, 2-4 Shutdown, 6-54 Standby, 6-53 Startup, 6-4 Symbols, 1-7 T Test Panel, 2-4 Throughput, B-3 troubleshooting, 11-1 Tubes, B-1 U Unclogging, 10-9 User Interface, 2-15 W WBC formula, 3-4 Measurement, 3-2 WBC Differential Accuracy, B-5 Worklist, 6-49
B-1 B Specifications and Performance B.1 Classification According to the CE classification, the BC-6800 belongs to In vitro diagnostic medical devices other than those covered by Annex II and devices for performance evaluation. B.2 Calibrator Blood samples with known values. Specified by manufacturer. B.3 Controls Specified by manufacturer. B.4 Reagents B.5 Applicable Tubes Size of applicable tubes in the autoloading mode: 11-13mm (external diameter) ×65-78mm/80-83mm (height without cap/with cap) Recommended tubes for analysis on BC-6800 in the autoloading mode: M-68DS DILUENT Diluent M-68DR DILUENT M-68LD LYSE M-68LN LYSE M-68LB LYSE Lyse M-68LH LYSE Probe Cleanser PROBE CLEANSER M-68FN DYE Dye M-68FR DYE M-68FD DYE
Specifications and Performance B-2 NOTE Some tubes may not adapt to the analyzer or tube rack (e.g. tubes with unique caps). Contact Mindray or your local distributor in this case. B.6 Parameters Name Abbreviation Default Unit White Blood Cell count WBC 109 /L Basophil number Bas# 109 /L Basophil percentage Bas% % Neutrophil number Neu# 109 /L Neutrophil percentage Neu% % Eosinophil number Eos# 109 /L Eosinophil percentage Eos% % Lymphocyte number Lym# 109 /L Lymphocyte percentage Lym% % Monocyte number Mon# 109 /L Monocyte percentage Mon% % Reticulocyte percentage RET% % Reticulocyte number RET# 106 /uL Immature Reticulocyte Fraction IRF % Low Fluorescent Ratio LFR % Middle Fluorescent Ratio MFR % High Fluorescent Ratio HFR % Red Blood Cell count RBC 1012 /L Hemoglobin Concentration HGB g/L Mean Corpuscular Volume MCV fL Mean Corpuscular Hemoglobin MCH pg Mean Corpuscular Hemoglobin Concentration MCHC g/L Red Blood Cell Distribution Width - Coefficient of Variation RDW-CV % Red Blood Cell Distribution Width - Standard Deviation RDW-SD fL Hematocrit HCT %
Specifications and Performance B-3 Nucleated Red Blood Cell count NRBC# 103 /uL Nucleated Red Blood Cell percentage NRBC% /100WBC Platelet count PLT 109 /L Mean Platelet Volume MPV fL Platelet Distribution Width PDW None Plateletcrit PCT % Platelet-Large Cell Ratio P-LCR % Platelet- Large Cell Count P-LCC 109 /L B.7 Sampling Features B.7.1 Sample volumes required for each analysis AL Mode ≤200μl OV-WB Mode ≤150μl PD Mode ≤40μl B.7.2 Throughput Throughput in Different Modes Analysis mode Whole Blood (analyses per hour) Predilute (analyses per hour) CBC 125 36 CBC+ DIFF 125 36 CBC+DIFF+RET 90 30 CBC+RET 90 30 CBC+NRBC 125 36 CBC+DIFF+NRBC 125 36 CBC+DIFF+RET+NRBC 90 30 RET 90 30
Specifications and Performance B-4 B.8 Performance specifications B.8.1 Display range B.8.2 Background/Blank Count Parameter Requirement WBC ≤ 0.1 109 / L WBC-D ≤ 0.2 109 / L WBC-N ≤ 0.2 109 / L RBC ≤ 0.02 1012 / L RBC-O ≤ 0.02 1012 / L HGB ≤ 1 g / L PLT ≤ 5 109 / L PLT-O ≤ 5 109 / L B.8.3 Linearity Range Parameter Linearity range Deviation Range (Whole Blood) Deviation Range (Predilute) (0 ~ 100.00)×109 /L ±0.20×109 /L or ±2％ ±0.50×109 /L or ±5％ (100.01 ~ 350.00)×109 WBC /L ±6％ ±6％ (350.01 ~ 500)×109 /L ±11％ ±11％ RBC (0 ~ 8.00)×1012/L ±0.03×1012/L or ±2％ ±0.05×1012/L or ±5％ HGB (0 ~ 250) g/L ±2g/L or ±2％ ±2g/L or ±3％ HCT (0 ~ 75)% ±1.0 (HCT value) or ±2 ％ (deviation percent) ±2.0 (HCT value) or ±4 ％ (deviation percent) PLT (0 ~ 1000)×109 /L ±10×109 /L or ±5％ ±10×109 /L or ±10％ Parameter Display range WBC 0.00~999.99×109 /L Neu%/ Lym%/ Mon%/ Eos%/ Bas% 0~100% RBC 0.00~99.99×1012/L HGB 0~300g/L PLT 0~9999×109/L HCT 0.0~100.0% MCV 0.0~250.0 fL RET% 0~100% RET＃ 0.00~999.99×109 /L NRBC% 0~9999.9% NRBC＃ 0-9999.99×102 /µL
Specifications and Performance B-5 (1001 ~ 5000)×109 /L ±6％ ±10％ RET% (0 ~ 30)% ±0.3 (RET value) or ±20 ％ (deviation percent) — RET# (0~0.8)×1012/L ±0.015×1012/L or ±20％ — B.8.4 Compatibility Deviation range: WBC≤±3%, RBC≤±2%, HGB≤±2%, PLT≤±5%, HCT/MCV≤±2%. B.8.5 WBC Differential Accuracy The differential results for neutrophils, lymphocytes, monocytes, eosinophils and basophils should fall in the permissible ranges of the results acquired by using the reference method (confidence interval: 99%). B.8.6 Reproducibility Parameter Condition Whole Blood Reproducibility CV% / absolute deviation (d) Predilute Reproducibility CV% / absolute deviation (d) WBC ≥ 4×109 /L ≤ 2.5% ≤ 4.0% RBC ≥3.5×1012/L ≤ 1.5% ≤ 2.0% HGB (110～180) g/L ≤ 1.0% ≤ 2.0% MCV (80～100) fL ≤ 1.0% ≤ 3.0% HCT (30～50)% ≤ 1.5% ≤ 3.0% MCH — ≤ 1.5% — MCHC — ≤ 1.5% — RDW-SD — ≤ 2.0% — RDW-CV — ≤ 2.0% — PLT ≥100×109 /L ≤ 4.0% ≤ 8.0% PDW — ≤ 10.0% — MPV — ≤ 3.0% — P-LCR — ≤ 15.0% — P-LCC — ≤ 15.0% — PCT — ≤ 5.0% — Neu% Neu%≥30.0% WBC≥ 4×109 /L ≤6.0% ≤12.0% Lym% Lym %≥15.0% WBC≥ 4×109 /L ≤6.0% ≤12.0% Mon% Mon %≥5.0% WBC≥ 4×109 /L ≤16.0% ≤32.0% Eos% WBC≥ 4×109 /L ≤20.0% or ±1.5% (d) ≤40.0% or ±3.0% (d) Bas% WBC≥ 4×109 /L ≤30.0% or ±1.0% (d) ≤60.0% or ±2.0% (d)
Specifications and Performance B-6 NRBC% WBC≥ 4×109 /L ≤20.0% or ±1.5% (d) — Neu# ≥1.20×109 /L ≤6.0% ≤12.0% Lym# ≥0.60×109 /L ≤6.0% ≤12.0% Mon# ≥0.20×109 /L ≤16.0% ≤32.0% Eos# WBC≥ 4×109 /L ≤20.0% or ±0.12×109 /L (d) ≤40.0% or ±0.24×109 /L (d) Bas# WBC≥ 4×109 /L ≤30.0% or ±0.06×109 /L (d) ≤60.0% or ±0.12×109 /L (d) NRBC# WBC≥ 4×109 /L ≤20.0% or ±0.12×109 /L (d) — RET# RBC≥ 3×1012/L RET%1%～4% ≤ 15% ≤ 30% RET% RBC≥ 3×1012/L RET%1%～4% ≤ 15% ≤ 30% LFR RBC≥ 3×1012/L RET%1%～4% LFR≥20% ≤ 30% — MFR RBC≥ 3×1012/L RET%1%～4% MFR≥20% ≤ 50% — HFR RBC≥ 3×1012/L RET%1%～4% ≤ 100% or ±2.0% (d) — IRF RBC≥ 3×1012/L RET%1%～4% IRF≥20% ≤ 30% — B.8.7 Carryover Parameter Carryover WBC ≤1.0％ RBC ≤1.0％ HGB ≤1.0％ HCT ≤1.0％ PLT ≤1.0％ RBC-O ≤1.5％ WBC-D ≤1.0％ WBC-N ≤1.5％ B.8.8 Correlation The correlation compared with the reference analyzer shall meet the requirements listed in the following table. Parameter Correlation Coefficient WBC ≥ 0.99 RBC ≥ 0.99
Specifications and Performance B-7 HGB ≥ 0.98 MCV ≥ 0.98 PLT ≥ 0.95 NRBC#/NRBC% ≥ 0.90 RET#/RET% ≥ 0.90 B.9 Input/Output Devices NOTE Be sure to use the specified devices only. B.9.1 External Computer PC (IBM compatible) CPU: Intel® 2.6GHz or above RAM: 2GB or above Hard disk: 320GB or above CD-ROM: DVD-RW At least 2 network adapters Operating system: Microsoft Windows Vista or above Microsoft Windows 7 32bit Home Basic, or Microsoft Windows 7 32bit Ultimate B.9.2 Keyboard (Optional) USB keyboard B.9.3 Mouse (Optional) USB mouse B.9.4 External Barcode Scanner (Optional) USB hand-held barcode scanner B.9.5 Printer (Optional) B.9.6 USB Flash Disk
Specifications and Performance B-8 B.10 Interfaces NOTE The USB interfaces on the back of the analyzer shall only be used to connect the peripheral devices specified in this manual. See Section B.9 Input/output device for details about supported devices and models. 1 network interface 1 pneumatic unit interface 4 USB interfaces B.11 Power Supply Voltage Frequency Power Analyzer a.c. 110V/115V ±10% 50/60Hz ±2Hz 500VA a.c. 220V/230V ±10% 50/60Hz ±2Hz 500VA a.c. 110V/115V ±10% 60Hz ±2Hz 600VA 50Hz ±2Hz 450VA Compressor a.c. 220V/230V ±10% 60Hz ±2Hz 300VA B.12 EMC Description This equipment complies with the emission and immunity requirements of the EN 61326-1:2006 and EN 61326-2-6:2006. This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. NOTE It is the manufacturer's responsibility to provide equipment electromagnetic compatibility information to the customer or user. It is the user's responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended.
Specifications and Performance B-9 B.13 Sound Pressure Maximal sound pressure: 65db NOTE Be sure to use and store the analyzer in the specified environment. B.14 Operating environment Ambient temperature: 15 ℃ - 32 ℃ Optimal operating humidity: 30% - 85% Atmospheric pressure: 70 kPa - 106 kPa B.15 Storage Environment Ambient temperature: -10 ℃ - 40 ℃ Relative humidity: 10% - 90% Atmospheric pressure: 50 kPa - 106 kPa B.16 Running Environment Ambient temperature: 5 ℃ - 40 ℃ Relative humidity: 10% - 90% Atmospheric pressure: 70 kPa - 106 kPa
Specifications and Performance B-10 B.17 Dimensions and Weight Analyzer Compressor Width (mm) ≤680 ≤310 Depth (mm) ≤850 ≤480 Height (mm) ≤700 ≤430 Weight (Kg) ≤125 ≤20 B.18 Contraindication None. B.19 Barcode Specifications The BC-6800 can read barcodes that are stuck to the test tubes. The sample ID read from the barcode will be stored and used as the only identification of the sample. The barcodes used shall meet the specifications stated in this section. 1. Supported barcode types All code types and check digit supported by BC-6800 are listed as follows. Barcodes Supported by BC-6800 Code Type Check Digit Number of Digits CODE128 Self-checking(check digit is always included) No more than 20 digits (sample ID) CODE93 Self-checking(check digit is always included) No more than 20 digits (sample ID) UPC/EAN Self-checking(check digit is always included) Fixed length: 8 or 13 digits Width Height Depth
Specifications and Performance B-11 Not use check digit No more than 20 digits (sample ID) ITF Use Check digit No more than 19 digits (sample ID)+1 digit (check digit) = no more than 20 digits Not use check digit No more than 20 digits (sample ID) CODE39 Use Check digit No more than 19 digits (sample ID)+1 digit (check digit) = no more than 20 digits Not use check digit No more than 20 digits (sample ID) CODABAR Use Check digit No more than 19 digits (sample ID)+1 digit (check digit) = no more than 20 digits NOTE The manufacturer suggest you use check digit to reduce the possibility of misreading. 2. Barcode label dimensions Barcode height: A≥10mm Label width: B≤45mm Clear area width: C≥5mm Wide-to-narrow ratio: between 2.5: 1 and 3.0: 1 Width of the narrowest bar: above 0.127mm Code quality: According to ANSI MH10.8M standard, the code quality shall be Level C or above. 3. Samples of valid and invalid barcode labels: Use of invalid barcode labels will increase the possibility of misreading. To ensure good readability, use valid labels as shown in the figure below.
Specifications and Performance B-12
C-1 C Communication C.1 Communication Protocol Overview C.1.1 Messages Supported by HL7 Interface Protocol The LIS/HIS communication function of BC-6800 enabled the communication between the analyzer and the PC in laboratory through Ethernet, including sending analysis results to and receiving worklist from lab PC. This communication protocol is defined based on the HL7 Standards. HL7 is a series of electronic data exchange standards for healthcare industry, which is originally defined by the US and is now adopted worldwide. This protocol is defined based on HL7 v2.3.1. For details of HL7 standards, see HL7 Interface Standards Version 2.3.1. C.1.2 Lower Transmission Layer Protocol BC-6800 sends messages through TCP connection, and the communication process can be segmented into 3 phases: Connecting Phase After the analyzer starts up, it tries to connect to the LIS/HIS server based on its software configuration. If the analyzer fails to connect to the server, will keep retrying until the connection is set up successfully; otherwise, it keeps connected to the server to ensure that data communication can be proceeded at any time. If the analyzer is disconnected from the LIS/HIS server while it is running, it will try to reconnect to the server. Data Transmission If the user enabled the auto communication function of analysis results, analysis result data can be transmitted once it is generated in the analyzer, besides being transmitted in batch in the Table Review or QC screen. The message sending and receiving processes are synchronous in both batch communication and auto communication. The user can configure whether to wait for the acknowledgement message after sending a message. If it is configured to wait for the acknowledgement message, once the acknowledgement message is not received in predefined time (e.g. 10s), the analyzer will consider the transmission as failed and resend the data. If it is configured not to wait for the acknowledgement message, the analyze will consider the transmission as failed and resend the data once the "Failed to receive" message is received in predefined time (e.g. 10s); otherwise, it will consider the transmission as succeeded and begin to send the next message. The bi-directional LIS/HIS inquiry message transmission is different. Before the analyzer enabling/disabling the LIS/HIS communication, saving worklist or starting analysis, it will send an inquiry message including the sample ID. LIS/HIS searches the sample information using
Communication C-2 the sample ID, and respond in the form of HL7 message. The analyzer fills up the worklist based on the response or performs sample analysis. If there is no respond in the predefined time (e.g. 10s) after the bi-directional LIS/HIS inquiry message is sent out, the inquiry will be considered as failed. Disconnection The communication is terminated when the operator exits from the BC-6800 software. The connection is also cut off while the communication setup of the software is being edited, and then the analyzer will try to reconnect based on the new settings. C.1.3 HL7 Message Layer Protocol HL7 Protocol Overview Message constructing principles Every HL7 message consists of several segments and ends up with the <CR> (0x0D) character. Each segment consists of the segment name of three characters and field of changeable characters, and each field consists of the component and subcomponent. For each message, the separators of the field, component and subcomponent are defined in the MSH segment. For example: MSH|^~\&|Mindray|BC-6800|||20060427194802||ORU^R01^ORU_R01|1|P|2.3.1||||||UNICOD E among which: The five characters following MSH define the separators to distinguish each field, component and subcomponent. Although they can be any non-text characters, HL7 standard recommends the characters in the table below: Character Meaning | Field separator ^ Component separator & Subcomponent separator ~ Repetition separator \ ESC The first field of MSH includes every separator. Some field behind are empty because they are optional and not used by Mindray HL7 interface. Detailed field definition and selection will be stated in the following sections.
Communication C-3 For message of any type, the segments behind MSH appear in the fixed order. The order will be described in the following contents and the grammar is used to organize the segments order. The segment appeared in [] is optional. The segment appeared in {} can be repeated once or more. String transferring principles For the field data of ST, TX, FT, and CF, etc. separators may be contained in the string data like remarks, clinical diagnosis and customized gender etc. When coding, the separators in the original strings shall be transferred into transferred character sequence; then, restore them when decoding. The transferring principles used in the BC-6800 HL7 interface protocol are shown in the table below: Transferred Character Original character \F\ Field separator \S\ Component separator \T\ Subcomponent separator \R\ Repetition separator \E\ Transferred separator \.br\ <CR>，i.e. end character of segment Note: “\” in the transferred character sequence represents the transferred separator. Its value is defined in MSH segment. HL7 Lower Layer Message Protocol TCP/IP is a protocol of byte stream. It doesn’t provide the message boundary. HL7 of upper layer protocol is based on messages. The function of terminating the message is not provided. In order to determine the message boundary, the lower layer protocol of MLLP is used (such descriptions are also included in HL7 Interface Standards Version 2.3). Communication Layer Messages are transmitted in the following format: <SB> ddddd <EB><CR> among which: <SB> = Start Block character (1 byte) ASCII <VT>, i.e. <0x0B>. Do not confuse with the SOH or STX character in ASCII. ddddd = Data (variable number of bytes) ddddd is the effective data of HL7 message and expressed in the form of string. For the strings used in the BC-6800 HL7 interface messages, the UTF-8 code is used.