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8-1

8

Using the QC Programs

8.1 Introduction

Quality Control (QC) consists of strategies and procedures that measure the precision and
stability of the analyzer. The results imply the reliability of the sample results. QC involves
measuring materials with known, stable characteristics at frequent intervals. Analysis of the
results with statistical methods allows the inference that sample results are reliable.

Mindray recommends you run the QC program daily.

A new lot of controls should be

analyzed in parallel with the current lot prior to their expiration dates. This may be
accomplished by running the new lot of controls twice a day for five days using any empty QC
files. The QC files calculate the mean, standard deviation and coefficient of variation for each
selected parameter. The instrument-calculated means of these ten runs should be within the
expected ranges published by the manufacturer.

This analyzer provides two QC programs – QC with controls and X-B analysis.

z

Samples, controls, calibrator 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.

z

Use the specified controls. Using controls other than the specified will lead

to misleading results.

z

Refer to the instructions of use of the controls for how to store and use the

controls.

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Summary of Contents for BC-2800

Page 1: ...BC 2800 Auto Hematology Analyzer Operator s Manual ...

Page 2: ......

Page 3: ...out 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 change without prior notic...

Page 4: ...ult in machine breakdown or personal injury z 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 z This equipment must be operated by skilled trained clinical professionals ...

Page 5: ...on 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 ...

Page 6: ...el number serial number and a brief description of the reason for return 2 Freight policy The customer is responsible for freight charges when this product is shipped to Mindray for service this includes customs charges 3 Return address Please send the part s or equipment to the address offered by the international Customer Service Department Company Contact Manufacturer Shenzhen Mindray Bio Medic...

Page 7: ...8 2 3 5 Serial Ports 2 8 2 3 6 Parallel Port 2 8 2 3 7 Power Supply for the Floppy Disk Drive 2 8 2 3 8 Power Indicator 2 8 2 3 9 Optional Devices 2 8 2 4 Instrument Software 2 9 2 4 1 Main Screen 2 9 2 4 2 Screen saver 2 10 2 4 3 System Menu 2 11 2 5 Reagents Controls and Calibrator 2 13 2 5 1 Diluent 2 13 2 5 2 Lyse 2 13 2 5 3 Rinse 2 14 2 5 4 E Z Cleanser 2 14 2 5 5 Probe Cleanser 2 14 2 5 6 Co...

Page 8: ...the analyzer 4 4 4 4 Installation Procedure 4 5 4 4 1 Connecting Regents 4 5 4 4 2 Installing Recorder Paper 4 9 4 4 3 Connecting the Keyboard 4 10 4 4 4 Connecting the Printer Optional 4 10 4 4 5 Connecting the Bar Code Scanner Optional 4 10 4 5 Starting the Analyzer 4 11 5 Customizing the Analyzer Software 5 1 5 1 Introduction 5 1 5 2 Password 5 2 5 2 1 Entering the Administrator Password 5 2 5 ...

Page 9: ...lts 7 2 7 2 1 Browsing in the Histogram Mode 7 2 7 2 2 Browsing in the Table mode 7 7 7 3 Searching for Interested Sample Results 7 17 7 3 1 Starting a Search 7 17 7 3 2 Reviewing search result in the Table mode 7 19 7 3 3 Reviewing Search Result in the Histogram Mode 7 29 8 Using the QC Programs 8 1 8 1 Introduction 8 1 8 2 QC With Controls 8 2 8 2 1 QC Editing 8 2 8 2 2 Running the Controls 8 6 ...

Page 10: ... 13 Prepare to Ship 10 21 10 4 Using the Status Program 10 23 10 5 Using the Self test Program 10 24 10 5 1 Testing the Fluidic System 10 25 10 5 2 Testing Motors and Recorder Printer 10 25 10 5 3 Testing Valves 10 26 10 5 4 Testing A D Interrupt 10 27 10 6 Log 10 28 10 7 Viewing System Configuration 10 30 10 8 Printing Management 10 31 10 9 Calibrating Sample Probe Position 10 32 10 10 Replacing ...

Page 11: ...Table of Contents 5 C Precautions Limitations and Hazards C 1 D Communication 8ID communication protocol D 1 E Communication 15ID communication protocol E 1 ...

Page 12: ......

Page 13: ...es for operating troubleshooting and maintaining the analyzer Read this manual carefully before operating your analyzer and operate your analyzer strictly as instructed in this manual z Operate your analyzer strictly as instructed in this manual z All illustrations in this manual are provided as examples only They may not necessarily reflect your analyzer setup or data displayed and must not be us...

Page 14: ... This Manual This manual contains information written for clinical laboratory professionals to learn about the BC 2800 hardware and software customize system settings perform daily operating tasks perform system maintenance and troubleshooting ...

Page 15: ... about how to use the BC 2800 to perform your daily operating tasks Chapter 6 Operating Your Analyzer learn about how to review the saved analysis results Chapter 7 Reviewing Sample Results learn about how to use the quality control programs Chapter 8 Using the QC Programs learn about how to calibrate the BC 2800 Chapter 9 Using the Calibration Programs learn about how to maintain service the BC 2...

Page 16: ...l capital bold and italic letters indicate a special operation defined in the following section such as SELECT Bold letters included in indicate text you can find on the screen such as Prepare to ship Bold letters indicate defined screen areas fields such as System Status area or chapter titles such as Chapter 1 Using This Manual All illustrations in this manual are provided as examples only They ...

Page 17: ... of the one you want to delete and press DEL or to press the arrow keys as needed to move the cursor to the character or digit to the right of the one you want to delete and press BackSpace on the external keyboard MODIFY to move the cursor to the character or digit you want to change and re enter the desired one using either the built in keypad or the external keyboard SELECT from pull down list ...

Page 18: ...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 You may find the following symbols on the analyzer or the reagents When you see It means EQUIPOTENTIALITY CAUTION...

Page 19: ...FACTURER AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY IRRITATING SUBSTANCE 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 HEA...

Page 20: ...Using This Manual 1 8 RETURNING AND RECYCLING THIS PRODUCT PLEASE CONSULT THE DISTRIBUTOR FROM WHOM YOU PURCHASED THE PRODUCT ...

Page 21: ...ectric shock disconnect power cord prior to removing or replacing fuse Replace fuse only with the type and rating specified 3 Biological risk 4 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 2 3 1 4 ...

Page 22: ...e 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 Figure 1 2 Warning label 5 To avoid being injured do not put hand under the motor when the machine is running 5 ...

Page 23: ...Using This Manual 1 11 Figure 1 3 Warning label 6 To avoid electrical shock disconnect the power supply before maintaining this device 6 ...

Page 24: ...Using This Manual 1 12 Figure 1 4 High voltage warning label 7 High Voltage 7 ...

Page 25: ...standing Your Analyzer 2 1 Introduction The BC 2800 Auto Hematology Analyzer is a quantitative automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories ...

Page 26: ...mphocyte percentage Lymph Mid sized cell percentage Mid Granulocyte percentage Gran Red Blood Cell or erythrocyte RBC Hemoglobin Concentration HGB Mean Corpuscular erythrocyte Volume MCV Mean Cell erythrocyte Hemoglobin MCH Mean Cell erythrocyte Hemoglobin Concentration MCHC Red Blood Cell erythrocyte Distribution Width Coefficient of Variation RDW CV Red Blood Cell erythrocyte Distribution Width ...

Page 27: ...Understanding Your Analyzer 2 3 2 3 User Interface Figure 2 1 Front view 1 LCD 2 Keypad 3 Recorder 4 Power indicator 5 Aspirate key 6 Sample probe ...

Page 28: ...Understanding Your Analyzer 2 4 Figure 2 2 Back view 1 Power switch 2 Equipotentiality 3 Waste outlet Red 4 Lyse inlet Orange 5 Rinse inlet Blue 6 Diluent inlet Green ...

Page 29: ...Understanding Your Analyzer 2 5 Figure 2 3 Left view 1 RS 232 port1 2 Parallel port 3 RS 232 port2 4 Power Interface of Floppy Disk Drive 5 Keyboard interface ...

Page 30: ...c and graphic data 2 3 2 Input Devices The input devices include the aspirate key built in keypad and PS 2 keyboard Aspirate key The aspirate key is located behind the sample probe as Figure 2 4 shows You can press the key to start the selected run cycle or dispense diluent Figure 2 4 Sample probe and aspirate key 1 Sample probe 2 Aspirate key ...

Page 31: ...to print out data by the recorder or printer HELP H or h Press it to call out the analyzer s on line help DEL Delete or Del Press it to delete data and characters ENTER Enter Press it to confirm or execute an operation Press them to move the cursor F1 F2 F3 F4 F5 F1 F2 F3 F4 F5 Press them to use various functions See the rest of this manual or the analyzer s on line help for details PgUp PgDn Page...

Page 32: ...be connected by a Mindray supplied cable 2 3 7 Power Supply for the Floppy Disk Drive It supplies power to the connected floppy disk drive Only the drive power cable supplied by Mindraycan be used 2 3 8 Power Indicator The power indicator tells you whether the analyzer is on off or in the screen saver mode 2 3 9 Optional Devices Printer An external printer can be connected to the parallel port at ...

Page 33: ...ich analysis count mode the next sample is to be analyzed In case of Figure 2 6 the next sample is to be analyzed in the Whole Blood All System Status Area The System Status area displays whether this analyzer is ready for the next analysis When it displays Ready it means this analyzer is ready and you can proceed to analyze the next sample When it displays Waiting it means the analyzer is not rea...

Page 34: ... Message area displays error messages one by one alternating every two seconds Reagent Status Area The Reagents Status area displays how many counts the remaining reagents are enough for Note that when it displays 99 counts it indicates the reagents are enough for over 99 counts and there is also enough space left in the waste container for the counts when it displays 0 counts it indicates either ...

Page 35: ... the MENU button and the system menu shown in Figure 2 7 below will pop up Figure 2 7 System menu The system menu contains 7 programs The programs followed by s have further sub menus See Figure 2 8 for the expanded menu Figure 2 8 Fully expanded system menu ...

Page 36: ...am as instructed below If you want to Select analyze samples Count review sample results Review run the QC program Quality Control customize system software Setup maintain service the analyzer Service calibrate the analyzer Calibration shut down the analyzer Shutdown ...

Page 37: ...oisture Product integrity may be compromised in packages that have been damaged If there is evidence of leakage or improper handling do not use the reagent z Store and use the reagents as directed by instructions for use of the reagents z When you have changed the diluent rinse or lyse run a background to see if the results meet the requirement z Pay attention to the expiration dates and open cont...

Page 38: ...an alkaline cleaning solution formulated to clean the fluidic lines apertures and bath 2 5 6 Controls and Calibrator The controls and calibrator are used to verify accurate operation of and calibrate the analyzer The controls are commercially prepared whole blood products used to verify that the analyzer is functioning properly They are available in low normal and high levels Daily use of all leve...

Page 39: ...measurement methods used in this analyzer are the impedance method for determining the WBC RBC and PLT data the colorimetric method for determining the HGB During each analysis cycle the sample is aspirated diluted and mixed before the determination for each parameter is performed ...

Page 40: ...ly present the sample to the sample probe and press the aspirate key to aspirate 13µL of the sample into the analyzer If you are going to analyze a capillary blood sample you should first manually dilute the sample 20 µL of capillary sample needs to be diluted by 1 6 mL of diluent and then present the pre diluted sample to the sample probe and press the aspirate key to aspirate 0 7 mL of the sampl...

Page 41: ...s reason the diluent is used to separate the cells so that they are drawn through the aperture one at a time as well as to create a conductive environment for cell counting Moreover red blood cells usually outnumber white blood cells by 1 000 times For this reason lyse needs to be added to the sample to eliminate the red cells before the WBC counting ...

Page 42: ...each count cycle The exact amount is determined by the distance between the two optical sensors The rinse is used to create a meniscus in the metering tube The count cycle starts when the meniscus reaches the upper sensor and stops when the meniscus reaches the lower sensor The amount of time required for the meniscus to travel from the upper sensor to the lower sensor is called the WBC Count Time...

Page 43: ...h pulse is proportional to the volume of each particle Each pulse is amplified and compared to the internal reference voltage channels which only accepts the pulses of certain amplitude If the pulse generated is above the WBC threshold it is counted as a WBC Figure 3 2 Impedance method of counting and sizing HGB measurement HGB is determined by the colorimetric method The WBC HGB dilution is deliv...

Page 44: ... white cells and WBC the corrected white cell number WBC differentia With the help of the diluent and lyse this analyzer can size the white cells into three sub populations lymphocytes mid sized cells including monocytes basophils and eosinophils and granulocytes Based on the WBC histogram this analyzer calculates Lymph Mid and Gran as follows and express the results in percents where PL particles...

Page 45: ...e You can also review the histograms of the stored patient results see Chapter 7 Reviewing Sample Results The first three discriminators of the WBC histogram can be adjusted in case you are not satisfied with the result Note that you cannot adjust them if the WBC result is less than 0 5 or out of the operating range 3 4 4 HGB Using the colorimetric method this analyzer calculates hemoglobin concen...

Page 46: ... count cycle The exact amount is determined by the distance between the two optical sensors The rinse is used to create a meniscus in the metering tube The count cycle starts when the meniscus reaches the upper sensor and stops when the meniscus reaches the lower sensor The amount of time required for the meniscus to travel from the upper sensor to the lower sensor is called the RBC Count Time and...

Page 47: ...ween the electrodes is produced This change produces a measurable electrical pulse The number of pulses generated indicates the number of particles that passed through the aperture The amplitude of each pulse is proportional to the volume of each particle Each pulse is amplified and compared to the internal reference voltage channels which only accepts the pulses of a certain amplitude If the puls...

Page 48: ...ibution Width Standard Deviation RBC Histogram Besides the parameters mentioned above this analyzer also presents an RBC histogram whose x coordinate represents the cell volume fL and y coordinate represents the number of the cells The histogram is presented in the Analysis Result area of the Count screen when the analysis is done You can also review the histograms of the stored patient results se...

Page 49: ...llows and express it in Where the PLT is expressed in 109 L and the MPV in fL PLT Histogram Besides the parameters mentioned above this analyzer also presents a PLT histogram whose x coordinate represents the cell volume fL and y coordinate represents the number of the cells The histogram is presented in the Analysis Result area of the Count screen when the analysis is done You can also review the...

Page 50: ...each analysis cycle each element of the analyzer is washed The sample probe is washed internally and externally with diluent The bath is washed with diluent and rinse The metering tube is washed with rinse The rest of the fluidic system is washed by diluent ...

Page 51: ...mponents function correctly and to verify system performance Mindray authorized representatives will handle the installation and initial software setup z Installation by personnel not authorized or trained by Mindray may damage your analyzer Do not install your analyzer without the presence of Mindray authorized personnel ...

Page 52: ...t least 10 cm behind for cabling and ventilation enough room on or below the countertop to accommodate the diluent rinse and waste containers 4 2 2 Power Requirements Check the availability of a power outlet that meets the following requirements Voltage 100 to 240 VAC Frequency 50 60 1 Hz Power 180VA Fuse 250V T4A z Make sure the analyzer is properly grounded z Replace fuse only with the type and ...

Page 53: ...ckering fluorescent lights and electrical contacts that regularly open and close Do not place the analyzer in direct sunlight or in front of a source of heat or drafts z Do not place the analyzer in a flammable or explosive environment z Do not place any container on the top of the analyzer z If the ambient temperature is outside the specified operating range the analyzer will alarm you for abnorm...

Page 54: ...e packing list Notify the Mindray customer service department or your local distributor immediately if you find anything missing Remove the top protective foam carefully carry out the analyzer from the box and place it on the countertop Remove the foam fixing the sample probe z Retain the shipping carton and all the packing materials as they can be used for packaging if analyzer must be reshipped ...

Page 55: ...reagents keep the reagents still for a while before using them z Never use expired reagents z To prevent contamination tighten the container caps when the installation is finished z Samples controls calibrator 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 4 4 1 Connec...

Page 56: ...nd tighten the cap until properly secured as Figure 4 2 shows Figure 4 2 Insert the tube end into the container 4 Locate the green fitting marked DILUENT in the lower right corner of the back of the analyzer 5 Plug the green connector of the tube into the fitting and turn it clockwise until properly secured Connecting the rinse container 1 Take out the rinse pickup tube the one with a blue connect...

Page 57: ...ten the cap until properly secured as Figure 4 4 shows Figure 4 4 Insert the tube end into the container 4 Locate the blue fitting marked RINSE in the lower right corner of the back of the analyzer 5 Plug the blue connector of the tube into the fitting and turn it clockwise until properly secured Connecting the lyse container 1 Take out the lyse pickup tube the one with an orange connector from th...

Page 58: ... the back of the analyzer 5 Plug the orange connector of the tube into the fitting and turn it clockwise until properly secured Connect the waste container 1 Take out the waste tube the one with a red connector from the accessory box 2 Locate the red fitting marked WASTE in the lower right corner of the back of the analyzer 3 Plug the red connector of the tube into the fitting and turn it clockwis...

Page 59: ... recorder door 4 Check if paper is installed correctly and the paper end is feeding from the top Figure 4 7 Installing recorder paper z Use only specified recorder paper Otherwise it may cause damage to the recorder head or the recorder may be unable to print or poor print quality may result z Never pull the recorder paper with force when a recording is in process Otherwise it may cause damage to ...

Page 60: ...oard interface marked KB 4 4 4 Connecting the Printer Optional Follow the printer s instructions for use to connect the printer to the parallel port 4 4 5 Connecting the Bar Code Scanner Optional Follow the scanner s instructions for use to connect the scanner to the serial port1 z Use the printer and scanner of the specified model ...

Page 61: ...et Place the power switch at the back of the analyzer in the ON position 1 to turn on the analyzer The power indicator light will be illuminated and the screen will display Initializing The analyzer will sequentially initialize the file hardware and fluidic systems and the whole initializing process lasts about 4 to 7 minutes When the initialization is finished the analyzer will automatically ente...

Page 62: ......

Page 63: ...lyzer Software 5 1 Introduction The BC 2800 is a flexible laboratory instrument that can be tailored to your work environment You can use the Setup program to customize the software options as introduced in Chapters 5 2 to 5 3 ...

Page 64: ...ertain options such as Count Gain etc 5 2 1 Entering the Administrator Password Press MENU to enter the system menu Figure 5 1 System menu SELECT Setup Password Figure 5 1 to enter the Password screen Figure 5 2 Figure 5 2 Password screen ENTER 2826 and press MENU a message box will pop up to remind you of the current password level as Figure 5 3 shows to remind you of the current password level ...

Page 65: ...menu 5 2 2 Resuming the Common User Password Enter the Password screen and the default password is the common user password Press MENU again and a message box will pop up to remind you of the current password level as Figure 5 4 shows Figure 5 4 A message box to confirm the user level CLICK Yes to confirm the password and exit to the system menu ...

Page 66: ...ngs screen as Figure 5 6 shows Figure 5 5 System menu Figure 5 6 Settings screen This screen can be interpreted as follows Setting Groups area on the left This area displays the visible or changeable setting groups You can press F1 to select the desired group The selected group is preceded by a Settings area on the right You can change the settings of the items displayed in this area Help area on ...

Page 67: ...ents You may set the remaining volumes for the diluent rinse and lyse When any of the entered volumes is counted down to zero the system will remind you to install a new container 1 SELECT Diluent Rinse or Lyse in the Remains field as needed 2 ENTER the desired digits See Table 5 1 for the valid reagent volumes Table 5 1 Valid reagent volumes Diluent Rinse Lyse Allowed range About 0 to 30 0 L Abou...

Page 68: ...d on the packaging of the reagent whichever is earlier Exiting the Reagent group When you have finished changing all the desired reagent settings you may 1 Press F1 to select another setting group you want to change or 2 Press MENU and a message box will pop up to remind you to save the changes as Figure 5 8 shows CLICK Yes to save the changes and exit to the system menu or CLICK No to exit to the...

Page 69: ... have selected the printer you can choose either of the following printing formats 1 Format1 One page with histogram 2 Format2 One page without histogram To select a printing format SELECT desired format from the Format drop down list If you have selected the recorder you can choose any of the following 4 printing formats 1 Format1 parameter values histograms 2 Format2 parameter values only 3 Form...

Page 70: ...utomatically print out the analysis results once they are done To activate this function SELECT ON or OFF from the Auto pull down list as Figure 5 12 shows Figure 5 12 Selecting auto printing Setting baud rate To choose one of the four baud rates 19200 9600 4800 2400 and 1200 SELECT the desired baud rate from the Baud drop down list as Figure 5 13 shows ...

Page 71: ...ing handshake If the Handshake function is activated to start the transmission this analyzer will send a handshake signal to an external computer and wait for the response If the computer does not respond this analyzer will abort the transmission and give an alarm for the transmission error If the Handshake function is deactivated this analyzer will transmit data to the external computer regardles...

Page 72: ... the analyzer s ability to automatically transmit the analysis results to an external computer once they are done To activate or deactivate this function SELECT On or Off from the Auto drop down list in the Transmit field as Figure 5 16 shows Figure 5 16 Auto communication Editing report titles external keyboard needed To edit the title of an analysis report 1 SELECT Recorder or Printer in the Rep...

Page 73: ... to save the changes as Figure 5 17 shows CLICK Yes to save the changes and exit to the system menu or CLICK No to exit to the system menu without saving the changes Figure 5 17 Saving changes 5 3 3 Date and Time You can select the Date time group to set the system date and time as Figure 5 18 shows Follow the instructions given below to do so Figure 5 18 Setting date and time Selecting the Date t...

Page 74: ...ime 1 SELECT Hour Minute or Second 2 ENTER the desired digits Exiting the Date time group When you have finished changing all the desired date and time settings you may 1 Press F1 to select another setting group you want to change or 2 Press MENU and a message box will pop up to remind you to save the changes as Figure 5 20 shows CLICK Yes to save the changes and exit to the system menu or CLICK N...

Page 75: ...s F1 to select the Gain group as Figure 5 21 shows Setting the WBC gain When WBC histograms of most samples are similar to Figure 5 22 it implies too small a WBC gain and you need to increase the gain appropriately Figure 5 22 WBC gain too small When WBC histograms of most samples are similar to Figure 5 23 it implies too large a WBC gain and you need to decrease the gain appropriately Figure 5 23...

Page 76: ...apter 5 2 1 2 At the Gain screen and ENTER the desired gain into the WBC WB as Figure 5 24 shows or WBC PB as Figure 5 25 shows Figure 5 24 Setting WBC WB gain Figure 5 25 Setting WBC PB gain Setting the RBC gain When the difference between the actual MCV result and the expected result exceeds 6 you need to change the RBC gain ...

Page 77: ...ows 4 ENTER the desired gain so that the adjustment becomes as close to 109 8 as possible Figure 5 26 Setting RBC gain Setting the HGB gain You may adjust the HGB gain to change the HGB blank voltage which usually should be set between 3 4 to 4 8V 4 5V recommended Follow the steps given below to set the HGB gain 1 Enter the administrator password as introduced in Chapter 5 2 1 2 At the Settings sc...

Page 78: ...u want to change or 2 Press MENU and a message box will pop up to remind you to save the changes as Figure 5 28 shows CLICK Yes to save the changes and exit to the system menu or CLICK No to exit to the system menu without saving the changes Figure 5 28 Saving changes 5 3 5 Count You can select the Count group to view or change if you have the administrator password the parameter units and count t...

Page 79: ...9 parameters are divided into 11 groups based on their units and you can only select unit for the first parameter of a group Pay special attention to the HGB group which includes HGB MCHC and MCH When you select g L or g dL as the unit of HGB the default unit for MCH is pg when you select mmol L as the unit of HGB the default unit of MCH is fmol Table 5 2 Units of Parameters Parameter Display form...

Page 80: ... 104 uL PLT nL fL Default MPV um3 PDW Default Default PCT mL L pg Default MCH fmol Follow the steps given below to select the units 1 Enter the administrator password as introduced in Chapter 5 2 1 2 At the Settings screen press F1 to select the Count group 3 SELECT the desired unit from the drop down list of the desired parameter as Figure 5 30 shows ...

Page 81: ...given below to change the WBC or RBC count time Refer to the actual count time see Chapter 10 5 1 for details when editing the count time Follow the steps given below to set the count time 1 Enter the administrator password as introduced in Chapter 5 2 1 2 At the Settings screen press F1 to select the Count group 3 SELECT WBC or RBC as Figure 5 31 shows 4 ENTER the desired digits Figure 5 31 Setti...

Page 82: ...n set a reference range for every parameter The system will flag any analysis result that exceeds this range with either an H or L This analyzer divides the patients into 5 patient groups which are all listed in Table 5 3 The default ranges are given Note that the default ranges are for references only Each laboratory is encouraged to establish its own references Table 5 3 Demographic groups Group...

Page 83: ...e 5 33 Reference range screen Selecting patient group Follow the steps given below to select the patient group you want 1 At the Settings screen press F1 to select the Ref Range group 2 SELECT the combo box to the right of Group Figure 5 34 Selecting patient group 3 SELECT General Man Woman Child or Neonate from the Group pull down list ...

Page 84: ...ng the patient group SELECT the desired parameter and ENTER the desired digits for the upper and lower limits Figure 5 35 Setting reference range 4 Press F2 to save the changes If the changes are successfully saved a message box shown in Figure 5 36 will pop up CLICK the Yes to close the message box Figure 5 36 A message box to note data saved 5 If some entered limits are invalid a message box sho...

Page 85: ...you want to change or 2 Press MENU to exit to the system menu 5 3 7 Auto Maintain You can select Auto Maintain group to view or set the how many WB samples can be run after perform auto maintaining Selecting Auto Maintain group Press F1 to select the Auto Maintain group Figure 5 38 Auto Maintain screen 1 The screen displays 1 how many WB samples had been run after auto cleaning and how many WB sam...

Page 86: ...tings screen press F1 to select the Auto Maintain group as Figure 5 39 shows 3 ENTER the desired digits Figure 5 39 Auto maintain screen 2 Exiting the Auto Maintain group When you have finished the changing you may 1 Press F1 to select another setting group you want to change or 2 Press MENU and a message box will pop up to remind you to save the changes as Figure 5 40 shows CLICK Yes to save the ...

Page 87: ...eper by pressing any key or leave it beeping until the errors are removed If you prefer the former SELECT Enabled from the Any key to mute drop down list if you prefer the latter SELECT Disabled from the Any key to mute drop down list See Figure 5 41 shows Figure 5 41 Selecting how to mute the beeper Selecting LCD contrast Follow the steps given below to adjust the LCD contrast 1 SELECT LCD contra...

Page 88: ...d in Table 5 4 should be displayed on the screen Table 5 4 Error List No Error No Error No Error 1 Communication Error 2 Scanner Error 3 Scanner Communication Error 4 Environmental Temperature Abnormal 5 Background Abnormal 6 HGB Error 7 HGB Adjustment 8 WBC Clog 9 WBC Bubbles 10 RBC Clog 11 RBC Bubbles 1 SELECT Alarm time s as Figure 5 43 shows 2 ENTER the desired digits ...

Page 89: ...iluted mode Follow the steps below to select the PMB color 1 Enter the administrator password as introduced in Chapter 5 2 1 2 At the Settings screen press F1 to select the Other group 3 SELECT Black default or Blue from the PMB color drop down list as Figure 5 44 shows Figure 5 44 Setting PMB color Delete data information list You can delete the information in the list of Dept Sender Tester and C...

Page 90: ... etc drop down list as Figure 5 45 shows Figure 5 45 Delete the information Exiting the Other group When you have finished changing all the parameter units and count time settings you want to change you may 1 Press F1 to select another setting group you want to change or 2 Press MENU and a message box will pop up to remind you to save the changes as Figure 5 46 shows SELECT Yes to save the changes...

Page 91: ...Customizing the Analyzer Software 5 29 Figure 5 46 Saving changes ...

Page 92: ......

Page 93: ... This chapter provides step by step procedures for operating your analyzer on a daily basis Whole Blood Mode Yes No Initial Checks Power on Daily Quality Control Sample Collection and Handling Run Whole Blood Samples Run Prediluted Samples Shutdown ...

Page 94: ...ing to government regulations 3 Checking tubing and power connections Check and make sure the diluent rinse and waste tubes are properly connected and not bent Check and make sure the power cord of the analyzer is properly plugged into an electrical outlet 4 Checking the printer optional and recorder Check and make sure enough printer or recorder paper is installed Check and make sure the power co...

Page 95: ...rdware and fluidic systems and the whole initializing process lasts 4 to 7 minutes depending on how the analyzer was previously shut down If any error occurs during the initialization the analyzer will display the error messages in the lower left corner of the screen You should remove all the errors before running any sample See Chapter 11 Troubleshooting Your Analyzer for solutions z Running samp...

Page 96: ...Operating Your Analyzer 6 4 6 4 Daily Quality Control Before running any samples run the controls See Chapter 8 Using the QC Programs for details ...

Page 97: ...to be analyzed is a whole blood sample and only the following parameters are analyzed RBC HCT MCV MCH MCHC RDW CV RDW SD PLT MPV PDW and PCT plus the RBC and PLT histograms 4 Prediluted All It means the sample to be analyzed is a prediluted blood sample and all the 19 parameters are to be analyzed plus 3 histograms 5 Prediluted WBC HGB It means the sample to be analyzed is a whole blood sample and...

Page 98: ...es and 20µL borosilicate glass capillary tubes 6 6 1 Whole Blood Samples Collect and handle the whole blood sample as follows 1 Collect venous blood with a K2EDTA 1 5 to 2 2mg mL anticoagulant collection tube 2 Rapidly and thoroughly mix the blood with the anticoagulant z You should collect at least 2mL venous blood sample z For the whole blood samples to be used for WBC differential or PLT count ...

Page 99: ...ssage box will pop up to instruct you how to dispense the diluent into the sample tube as Figure 6 1 shows Figure 6 1 A message box showing you how to dispense diluent 4 Present a clean sample tube to the sample probe and make sure the tube is tilted towards the probe as Figure 6 2 shows to avoid spills and bubbles Press the aspirate key to dispense 0 7mL of diluent the dispensing volume is contro...

Page 100: ...ube do not use cotton balls z After mixing the capillary sample with the diluent wait 5 minutes before running the sample z Run the prediluted samples within 30 minutes after the mixing z Mix any sample that has been prepared for a while before running it z Evaluate predilute stability based on your laboratory s sample population and sample collection techniques or methods ...

Page 101: ... samples Otherwise the obtained results may be erroneously flagged z When you save the next sample information run sample analysis Otherwise the input sample information cannot be displayed when restarting the analyzer 6 7 1 Entering Sample Information You may enter sample information in any of the three modes ID only All info and Batch edit depending on which of the three configurations your anal...

Page 102: ...the analyzer or At the Count screen press F1 to enter the ID window and ENTER the sample ID Figure 6 4 Next sample window When you have finished entering the sample ID you may press MENU and a dialog box will pop up as Figure 6 5 shows To ignore the entered number CLICK No otherwise CLICK Yes Figure 6 5 Dialog box ...

Page 103: ... edit window will pop up as Figure 6 6 shows Figure 6 6 Entering sample information Entering sample ID ENTER the ID number in the ID box or if you have the bar code scanner installed you can simply scan the sample ID into the analyzer Selecting patient gender SELECT the desired item from the Gender drop down list as Figure 6 7 shows Note that you can select blank in case you are not aware of the p...

Page 104: ...esired number an integer from 0 to 12 into the Months box To enter the patient age in days ENTER the desired number an integer from 0 to 31 into the Days box Entering the chart number ENTER the number of the patient s medical chart into the Chart No box Entering the bed number ENTER the number of the patient s bed into the Bed No box Entering the department name You can either directly ENTER the n...

Page 105: ... the Reviewer box or SELECT the desired name from the Checker pull down list if there are previously saved names in the list All the three pull down lists are capable of saving 30 entered names Exit edit When you have finished entering all the desired sample information CLICK the Yes button to save the changes and return to the Count screen If you do not want to save the entered information CLICK ...

Page 106: ...to CLICK Prev or Next to review the previous or next sample until the desired sample is reached Delete If you want to delete the currently displayed sample information CLICK Delete to complete the deletion Exit When you are done with the batch CLICK Exit to exit to the Count screen After a sample is analyzed its corresponding sample information will be automatically displayed in the Current sample...

Page 107: ...e probe is out of the tube 1 Present the mixed sample to the sample probe so that the tip is well into the tube and press the aspirate key The System Status area will display Running and the analyzer will start aspirating sample 2 When you hear the beep and the sample probe is out of the tube remove the sample tube The sample probe will retract into the analyzer and the analysis progress will be d...

Page 108: ...al Functions Recount optional function If the system detects clog or bubbles during the analysis or you don t satisfied with the result and press F5 a dialog box will pop up to ask you whether you want to have a re count analyze this sample again as Figure 6 10 shows Figure 6 10 Re count dialog box If you don t want to re count this sample CLICK No otherwise CLICK Yes to enter the Re count screen ...

Page 109: ... followed by an H or L it means the analysis result has exceeded the upper or lower limit of the reference range If you see as opposed to the result it means the result is either unreliable or out of the operating range If the WBC result is less than 0 5 109 L this analyzer will not perform the differential analysis and all the related parameter values will be non numeric z The result of the backg...

Page 110: ...inophilia R4 indicates abnormality on the right side of the granulocytes hump and netrophilia Rm indicates at least two R flags Abnormal PLT histograms will be flagged by one of the markings Pm PS and PL Pm indicates blur demarcation between the platelet and red blood cell area and possible presence of large platelet platelet coagulation small red blood cell cell debris or fibrin PS indicates exce...

Page 111: ... samples Otherwise the obtained results may be erroneously flagged 6 8 1 Entering Sample Information You may enter sample information in any of the three modes ID only All info and Batch edit depending on which of the three configurations your analyzer has ID only All Info ID only and Batch edit ID only To enter the sample ID of the next sample you may At the Count screen use the bar code scanner ...

Page 112: ... have finished entering the sample ID you may press MENU and a dialog box will pop up as Figure 6 14 shows To ignore the entered number CLICK No otherwise CLICK Yes Figure 6 14 Dialog box z If you intend to do the background check instead of a patient sample enter 0 into the ID box ...

Page 113: ...e 6 15 Entering sample information Entering sample ID ENTER the ID number in the ID box or if you have the bar code scanner installed you can simply scan the sample ID into the analyzer Selecting the patient gender SELECT the desired item from the Gender drop down list as Figure 6 16 shows Note that you can select blank in case you are not aware of the patient gender ...

Page 114: ...R the desired number an integer from 0 to 12 into the Months box To enter the patient age in days ENTER the desired number an integer from 0 to 31 into the Days box Entering the chart number ENTER the number of the patient s medical chart into the Chart No box Entering the bed number ENTER the number of the patient s bed into the Bed No box Entering the department name You can either directly ENTE...

Page 115: ... the Reviewer box or SELECT the desired name from the Checker pull down list if there are previously saved names in the list All the three pull down lists are capable of saving 30 entered names Exit edit When you have finished entering all the desired sample information CLICK the Yes button to save the changes and return to the Count screen If you do not want to save the entered information CLICK ...

Page 116: ...o delete the currently displayed sample information CLICK Delete to complete the deletion Exit When you are done with the batch CLICK Exit to exit to the Count screen After a sample is analyzed its corresponding sample information will be automatically displayed in the Current sample area 6 8 2 Running the Samples z Samples controls calibrator and waste are potentially infectious Wear proper perso...

Page 117: ... will start aspirating sample 2 When you hear the beep and the sample probe is out of the tube remove the sample tube The sample probe will retract into the analyzer and the analysis progress will be displayed on the screen 3 When the analysis is finished the result will be displayed on the screen and the sample ID will automatically increase by 1 and the sample probe will be repositioned And if t...

Page 118: ...ult is less than 0 5 109 L this analyzer will not perform the differential analysis and all the related parameter values will be non numeric z The result of the background check will not be flagged Histogram flags The system will flag abnormal histograms Abnormal WBC histograms will be flagged by one of the markings R1 R2 R3 R4 and Rm R1 indicates abnormality on the left side of the lymphocyte hum...

Page 119: ...ell debris or fibrin PS indicates excessive small PLTs PL indicates excessive large PLTs z When the PLT value is less than 100 109 L a manual count by the microscope is recommended Adjusting histograms manually If you are not satisfied with the obtained histograms you can adjust them manually provided you have the administrator password See Chapter 7 Reviewing Sample Results for details ...

Page 120: ...t has been running continuously for 24 hours z Shut down the analyzer strictly as instructed below 1 Press MENU to enter the system menu and SELECT Shutdown as Figure 6 20 shows Figure 6 20 Selecting the shutdown program 2 A message box will pop up to ask you to confirm the shutdown as Figure 6 21 shows Figure 6 21 Shutdown message box 3 CLICK Yes and a window will pop up to instruct you how to sh...

Page 121: ...E Z cleanser to the sample probe and press the aspirate key The analyzer will aspirate the E Z cleanser and automatically clean the fluidic lines and the bath The cleaning progress will be displayed on the screen as Figure 6 23 shows Figure 6 23 Shutdown progress bar 5 When the cleaning is finished place the switch at the back of the analyzer to OFF O to turn off the analyzer 6 Empty the waste con...

Page 122: ...Operating Your Analyzer 6 30 z Dispose of reagents waste samples consumables etc according to government regulations ...

Page 123: ...lts 7 1 Introduction The analyzer automatically saves analysis results Totally 10 000 results can be saved You can either browse all the saved sample results in general or search for the results of a particular sample or samples ...

Page 124: ...one sample result per screen The Table mode In this mode the sample results are presented in a columnar fashion without histograms namely you can only see the parameter values One screen displays a maximum of 8 sample results 7 2 1 Browsing in the Histogram Mode Entering the Histogram mode Press MENU to enter the system menu and SELECT Review Figure 7 1 to enter the Review screen Figure 7 2 Figure...

Page 125: ... mode To switch to the Table mode press to switch back to the Histogram mode press again Jumping to a sample result with known location Press F1 and a Goto window will pop up as Figure 7 3 shows Figure 7 3 Goto window ENTER the location into the Location box and press ENTER to jump to the desired sample result Editing sample information if configured Press F2 to edit the sample information Figure ...

Page 126: ... first way is designed for the patients no younger than one year the second for the patients older than one month and younger than one year the third for the patients younger than one month You can choose only one of the three ways to enter the patient age To enter the patient age in years ENTER the desired number an integer from 0 to 200 into the Years box To enter the patient age in months ENTER...

Page 127: ... the Checker pull down list if there are previously saved names in the list All the three pull down lists are capable of saving 30 entered names Yes button When you have finished entering all the desired sample information CLICK the Yes button to save the changes and return to exit the edit window No button If you do not want to save the entered information CLICK the No button to return to exit th...

Page 128: ...5 WBC histogram with adjustable discriminators 2 Press or as needed to select the WBC histogram as Figure 7 6 shows Figure 7 6 Adjusting discriminator 1 3 Press F3 to select the third discriminator as Figure 7 7 shows Figure 7 7 Adjusting discriminator 2 4 Press to move the third discriminator as Figure 7 8 shows ...

Page 129: ...s to save the changes and return to the Review screen Printing sample results Press PRINT to print out the current sample result 7 2 2 Browsing in the Table mode At the Histogram mode press to switch to the Table mode as Figure 7 10 shows Figure 7 10 Sample table review screen The sample results are sequentially displayed on the screen The Loc Total displayed in the ...

Page 130: ...s of the current sample result press to switch to the Histogram mode To switch back to the Table mode press again Jumping to a sample result with known location Press F1 and a Goto window will pop up as Figure 7 11 shows Figure 7 11 Goto window ENTER the location into the Location box and press ENTER to jump to the desired sample result You can select certain desired samples for transmission or pr...

Page 131: ...e sample is deselected the will disappear as Figure 7 13 shows Figure 7 13 Deselecting a sample result Selecting deselecting multiple sample results Example1 To select the sample results of locations 1 to 5 sample IDs 114 to 118 follow the procedure below to do so 1 Press F2 to enter the Select window as Figure 7 14 shows ...

Page 132: ...ws Figure 7 15 Selecting sample results of locations 1 5 5 CLICK Exit to return to the sample table review screen The selected sample results will be marked with as Figure 7 16 shows Figure 7 16 Reviewing the selected results Example2 To deselect the sample results of locations 1 to 5 follow the procedure below to do so 1 Enter the start and end positions as instructed in steps 1 to 3 of Example1 ...

Page 133: ...ws Figure 7 18 Reviewing the deselected results Example3 To select the sample results of locations 1 to 5 and 7 to 8 follow the procedure below to do so 1 Select the sample results of locations 1 to 5 as instructed in steps 1 to 4 of Example1 2 Select the sample results of locations 7 to 8 as instructed in steps 1 to 4 of Example1 3 CLICK Exit to return to the sample table review screen The select...

Page 134: ...to 3 of Example2 2 Deselect the sample results of locations 7 to 8 as instructed in steps 1 to 3 of Example2 3 CLICK Quit to return to the sample table review screen The above those sample results will disappear as Figure 7 20 shows Figure 7 20 Reviewing the deselected results Transmitting sample results to a host You can transmit the selected or all sample results to an external computer a host P...

Page 135: ...inting sample results Select the sample results you want to print and press PRINT A message box will pop up to ask you to confirm the printing as Figure 7 22 shows CLICK Yes to print out all the selected results CLICK No to abort the printing Figure 7 22 Print message box Special functions To access the Special Functions screen you must first select several 1 to 500 sample results and then press F...

Page 136: ... 24 Special functions screen only open to administrators Reproducibility See Figure 7 23 for the Special Functions screen open to all users The screen consists of two fields the left displaying the available functions and the right displaying the 19 parameters and their reproducibility indices Mean Diff and CV If the selected samples are less than 3 the reproducibility indices are all 0 If the ana...

Page 137: ... 7 25 and Figure 7 26 show You can press to switch between the screens The selected results are sequentially presented in the trend newest at the utmost left No 1 Figure 7 25 Trend screen 1 Figure 7 26 Trend screen 2 At either screen you can press or to view the results displayed below the parameter box of every point presented in the graph The current cursor position is displayed to the right of ...

Page 138: ... For every parameter the three numbers on the right of its trend represents Mean the mean value of the saved results Diff standard deviation of the saved analysis results CV Coefficient of Variation where n represents how many sample results are selected and Xi is the result of the ith analysis If the selected samples are less than 3 the three indices will all be 0 If the analysis result of certai...

Page 139: ...he sample table review screen press F4 to enter the Search window as Figure 7 27 shows Figure 7 27 Search window To include a search condition press or to move the cursor to the desired condition and press ENTER to select the condition as Figure 7 28 shows Figure 7 28 All search conditions are included ...

Page 140: ...tering sample ID ENTER the ID number into the ID box Entering the bed number ENTER the number of the patient s bed into the Bed No box Entering the chart number ENTER the number of the patient s medical chart into the Chart No box Entering the start and end date ENTER the start date into the Start box ENTER the end date into the End box CLICK Yes to start the search The analyzer will search the sa...

Page 141: ...er can display a maximum of 500 matches z The matches will be deleted if you have run another sample including background check or deleted a sample result or restarted the analyzer after the search Entering the Table mode At the Review screen press to select the Searched database and then press to enter the Table screen as Figure 7 30 shows ...

Page 142: ...mple results matching the search conditions Browsing sample results Press or to browse the preceding or following sample result press PgUp or PgDn to browse the preceding or following screen Switching to the Histogram mode If you are interested in reviewing the histograms of the current sample result press to switch to the Histogram mode To switch back to the Table mode press again Jumping to a sa...

Page 143: ...r transmission or printing Selecting deselecting a sample result Press or to move the cursor to the desired sample result and press ENTER to select it The selected sample result will be marked with a as sample 118 in Figure 7 32 shows Figure 7 32 Selecting a sample result Press ENTER again to deselect the sample result Once the sample is deselected the will disappear as Figure 7 33 shows ...

Page 144: ...ollow the procedure below to do so 1 Press F2 to enter the Select window as Figure 7 34 shows Figure 7 34 Entering the Select window 2 ENTER the start position 00001 into the From box 3 ENTER the end position 00005 into the To box 4 CLICK Select and the lower left corner of the Select window will display Select samples as Figure 7 35 shows Figure 7 35 Selecting sample results of locations 1 to 5 ...

Page 145: ...of locations 1 to 5 follow the procedure below to do so 1 Enter the start and end positions as instructed in steps 1 to 3 of Example1 2 CLICK De select and the lower left corner of the Select window will display De select the result as Figure 7 37 shows Figure 7 37 Deselecting the sample results of locations 1 to 5 3 CLICK Exit to return to the sample table review screen The above those sample res...

Page 146: ...s 7 to 8 as instructed in steps 1 to 4 of Example1 3 CLICK Exit to return to the sample table review screen The selected sample results will be marked with as Figure 7 39 shows Figure 7 39 Reviewing the selected results Example4 To deselect the sample results of locations 1 to 5 and 7 to 8 follow the procedure below to do so 1 Deselect the sample results of locations 1 to 5 as instructed in steps ...

Page 147: ...lts Transmitting sample results to a host You can transmit the selected or all sample results to an external computer a host Press F3 to enter the Transmit window as Figure 7 41 shows Figure 7 41 Transmit screen To transmit the selected sample results to a host CLICK Selected To transmit all the sample results CLICK All To stop a transmission CLICK Stop To return to the review screen CLICK Exit ...

Page 148: ...e printing Figure 7 42 Print message box Special functions To access the Special Functions screen you must first select several 1 to 500 sample results and then press F5 to enter the Special Functions screen as Figure 7 43 shows Figure 7 43 Special functions screen open to all users Two special functions are included in this screen Reprodu and Trend The former is open to all users as Figure 7 43 s...

Page 149: ...ty indices are all 0 If the analysis result of certain parameter is invalid the corresponding index will also be invalid Trend After entering the administrator password you can enter the Special Functions screen open to administrators as Figure 7 44 shows Press F1 to access the Trend which displays the WBC RBC PLT HGB MCV and RDW CV trends of the selected sample results The six trends are displaye...

Page 150: ...e was analyzed is displayed to the right of Time You can also press PgUp or PgDn to jump forward or backward by 20 samples The trend is interpreted as follows The x coordinate represents how many sample results have been selected The y coordinate represents the analysis results of the displayed parameters For every parameter the upper dash line of its trend represents the upper limit of the expect...

Page 151: ...is If the selected samples are less than 3 the three indices will all be 0 If the analysis result of certain parameter is invalid the three indices will also be invalid Under these two circumstances the three values on the left of the trends are the parameter s means and expected ranges set by the user see Chapter 5 3 6 Every point in the graph is interpreted as follows The darkened square that fa...

Page 152: ...g sample result press PgUp or PgDn to jump 8 locations e g jumping from location 1 to location 8 Switching to the Table mode To switch to the Table mode press to switch back to the Histogram mode press again Jumping to a sample result with known location Press F1 and a Goto window will pop up as Figure 7 48 shows Figure 7 48 Goto window ...

Page 153: ...nder Entering patient name ENTER the patient name into the Name box Entering patient age This analyzer provides three ways for you to enter the patient age in years in months and in days The first way is designed for the patients no younger than one year the second for the patients older than one month and younger than one year the third for the patients younger than one month You can choose only ...

Page 154: ... name into the Tester box or SELECT the desired name from the Tester pull down list if there are previously saved names in the list to enter the name of the person who is to review the sample results enter the name into the Reviewer box or SELECT the desired name from the Checker pull down list if there are previously saved names in the list All the three pull down lists are capable of saving 30 e...

Page 155: ...le For example to move the third discriminator of the following WBC histogram follow the procedure below to do so 1 Press ENTER and the discriminator will become adjustable See Figure 7 50 Figure 7 50 WBC histogram with adjustable discriminators 2 Press or as needed to select the WBC histogram as Figure 7 51 shows Figure 7 51 Adjusting discriminator 1 3 Press F3 to select the third discriminator a...

Page 156: ...gure 7 54 shows Figure 7 54 Saving changes CLICK Yes to save the changes and return to the Review screen Printing sample results Select the sample results you want to print and press PRINT A message box will pop up to ask you to confirm the printing as Figure 7 55 shows CLICK Yes to print out all the selected results CLICK No to abort the printing Figure 7 55 Print message box ...

Page 157: ...ed by running the new lot of controls twice a day for five days using any empty QC files The QC files calculate the mean standard deviation and coefficient of variation for each selected parameter The instrument calculated means of these ten runs should be within the expected ranges published by the manufacturer This analyzer provides two QC programs QC with controls and X B analysis z Samples con...

Page 158: ...n and Gran into a QC run Figure 8 1 System menu Figure 8 2 Controls screen Selecting a QC file The analyzer provides 9 QC files for you to save QC settings and results Every QC file can save the results of a maximum of 31 QC runs When the saved QC results have reached the maximum number the newest result will overwrite the oldest You can press F1 to switch the QC files and the number will be given...

Page 159: ...apter 8 2 3 for details Entering the QC Edit screen Press F3 at Controls screen to enter the QC Edit screen Figure 8 3 Figure 8 3 QC Edit screen Entering lot number ENTER the lot number of the control to be used into the Lot No box as Figure 8 4 shows Figure 8 4 Entering lot number Entering expiration date ENTER the expiration date of the control to be used into the Exp Date box as Figure 8 5 ...

Page 160: ...boxes of the parameters to be included in the QC analysis as Figure 8 6 shows Figure 8 6 Entering Mean of RBC z Refer to the instructions of use of the control for information on the lot number expiration date open vial stability days expected results and limits z The entered expiration date should be either the expiration date printed on the labeling or the open vial expiration date It is earlier...

Page 161: ...l pop up if 1 There is a parameter for which you have entered only the expected result or the limit or 2 There is a parameter whose expected result is less than or equal to the limit Figure 8 7 invalid input CLICK Yes to close the box and clear the erroneous entries Re enter the correct values before trying to exit the screen again The settings can be saved only when both the expected result and l...

Page 162: ...ng them in the laboratory z The sample probe tip is sharp and may contain biohazardous materials Exercise caution to avoid contact with the probe when working around it z Do not re use such disposable product as collection tubes test tubes capillary tubes etc z Keep the sample probe tip away from the tube bottom otherwise the aspiration volume may be inaccurate z When the aspiration is done remove...

Page 163: ...ll automatically increase by 1 and the sample probe will be repositioned z If the analyzer detects WBC RBC clogging or bubbles during the analysis the corresponding error messages will be displayed in the lower left corner of the screen and the results of all the related parameters will be invalidated See Chapter 11 Troubleshooting Your Analyzer for solutions z If the ambient temperature is outsid...

Page 164: ...e is tilted towards the probe as Figure 8 11 shows to avoid spills and bubbles Press the aspirate key to dispense 0 7ml of diluent the dispensing volume is controlled by the analyzer into the tube Figure 8 11 How to dispense diluent 5 When the dispensing is finished press ENTER to close the message box 6 Add 20µL of control to the diluent and shake the tube to mix the sample 7 Present the mixed co...

Page 165: ...the screen and the results of all the related parameters will be invalidated See Chapter 11 Troubleshooting You Analyzer for solutions z If the ambient temperature is outside the specified operating range the analyzer will alarm you for abnormal ambient temperature and the analysis results may be unreliable See Chapter 11 Troubleshooting You Analyzer for solutions Deleting the QC Result To delete ...

Page 166: ...an review the saved results in either of the two modes L J Graph and QC Table L J Graph At the Controls screen press F4 to enter the L J Graph screen as Figure 8 13 Figure 8 14 and Figure 8 15 shows Figure 8 13 L J graph screen 1 Figure 8 14 L J graph screen 2 ...

Page 167: ...rameter the upper dash line of its L J graph represents the upper limit of the expected range of the analysis result The corresponding value 4 9 in case of the WBC in Figure 8 13 equals Mean Range and is displayed to the left of the line For every parameter the lower dash line of its L J graph represents the lower limit of the expected range of the analysis result The corresponding value 4 1 in ca...

Page 168: ...the control range do the following steps until the problem is solved If all the steps have failed contact Mindray customer service department or your local distributor for assistance 1 Check the lower left corner of the screen for error messages Refer to Chapter 11 Troubleshooting Your Analyzer for solutions to any displayed error messages 2 Check the L J settings for inappropriate entries 3 Do th...

Page 169: ... the deletion as Figure 8 17 shows Figure 8 17 Deleting all the result CLICK Yes to delete current result CLICK No to abort the deletion If you want to transmit the saved QC results to an external computer follow the steps given below 1 Press F1 at QC Table screen to enter the dialog box shown in Figure 8 18 2 SELECT Yes to confirm the transmission ...

Page 170: ...Using the QC Programs 8 14 Figure 8 18 Transmission dialog box ...

Page 171: ...alyzer by tracking the average red cell indices MCV MCH and MCHC on the patient samples run through the instrument in batches of 20 The Target Value for X B is similar to the assay value for a commercial control It is derived from the patient population analyzed on the instrument The Limit is the acceptable limit of variation around the target value The X B analysis demands random samples and ther...

Page 172: ... you need to delete them first Press DEL and a message box will pop up to confirm the deletion as Figure 8 21 shows Figure 8 21 Deleting all the result CLICK Yes to confirm the deletion CLICK No to abort the deletion Entering Editing X B Settings At the X B Table screen press F1 to enter the X B Edit screen as shown in Figure 8 22 Figure 8 22 X B Edit screen ...

Page 173: ...ws Figure 8 23 Enabling disabling X B Edit Entering the expected result mean and limit range The expected results vary depending on laboratories It is recommended they are obtained by calculating the averages of at least 500 random patient samples The recommended limit is 5 to 10 z Calibrate your analyzer before trying to establish the expected results by calculating the averages of random patient...

Page 174: ... you have enabled the X B analysis and assigned valid means and ranges to the three parameters the system will automatically run the X B analysis every 20 patient samples of which the MCV MCH and MCHC results are within the set ranges 8 3 3 Reviewing X B Results This analyzer automatically saves the results of the X B analyses You can review the saved results in two modes X B table and X B graph X...

Page 175: ...very parameter e g MCV the three numbers to the left of the X B graph are defined as follows 95 0 expected result limit 90 0 expected result 85 0 expected result limit The points fallen between the upper and lower dash lines are within the expected ranges The points fallen outside the upper and lower dash lines are out of the expected ranges If you see any points fallen outside the control range d...

Page 176: ...n press PgUp or PgDn to review the preceding or following result The parameter value of the current point the one the cursor is located at is displayed below the parameter The location of the current point is displayed in the No field The analysis time is displayed in the Time field Printing X B graphs Press PRINT to print out the displayed X B graphs Exiting the X B Graph screen Press MENU to exi...

Page 177: ... materials and reagents used You should only use the calibrator and reagents specified by Mindray for the calibration Store and use the calibrator and reagents as directed by their instructions for use Calibration may be performed with commercial calibrator or fresh whole blood samples Only the directly measured parameters WBC RBC HGB MCV PLT and MPV may be calibrated ...

Page 178: ...am if It is the first time the analyzer has been used Certain major component s of the analyzer has been changed The quality control results indicate there may be a problem z All of the measured parameters must be calibrated before readings of this analyzer can be used as valid analysis results ...

Page 179: ...s see Chapter 11 Troubleshooting Your Analyzer for solutions Enter the Count screen and run a vial of normal control 11 consecutive times Enter the Review screen to check the reproducibility of the second to eleventh runs and make sure they meet the following requirements Table 9 1 Reproducibility Parameter Expected range CV WBC 4 0 to 15 0 109 L 3 0 RBC 3 00 to 6 50 1012 L 2 0 HGB 100 to 180 g L ...

Page 180: ...ult of background check Enter the administrator password as instructed in Chapter 5 2 1 and then choose one or several parameters among WBC RBC HGB MCV and PLT for calibration 9 3 2 Calibration Using Calibrator Program ENTER the administrator password in the Password screen Press MENU to enter the system menu Figure 9 1 System menu SELECT Calibration Calibrator Figure 9 1 to enter the Calibrator s...

Page 181: ...sed into the Exp Date box Entering the expected results mean and limits range ENTER the expected results mean into the Mean box of the parameters to be included in the calibration z Refer to the instructions of use of the calibrator for information on the lot number expiration date expected results and limits z Open reagents are stable for 60 days The entered expiration date should be the open dat...

Page 182: ...iration is done remove the sample tube only when the sample probe is out of the tube z Samples controls calibrator 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 z The sample probe tip is sharp and may contain biohazardous materials Exercise caution to avoid contact wi...

Page 183: ...rds the probe as Figure 9 5 shows to avoid spills and bubbles Press the aspirate key to dispense 0 7mL of diluent the dispensing volume is controlled by the analyzer into the tube Figure 9 5 How to dispense diluent 4 When the dispensing is done press ENTER to close the message box 5 Make sure the calibrator is at room temperature and not expired 6 Add 20µL of calibrator into one of the prepared sa...

Page 184: ...e invalidated See Chapter 11 Troubleshooting Your Analyzer for solutions z If the ambient temperature is outside the specified operating range the analyzer will alarm you for abnormal ambient temperature and the analysis results may be unreliable See Chapter 11 Troubleshooting Your Analyzer for solutions Saving the calibration results If non numeric parameter values are obtained a message box will...

Page 185: ...is recommended and the analyzer will automatically calculate the CVs and calibration factors as Figure 9 8 shows Figure 9 8 Results of the calibration The calculated calibration factor should be within the 75 to 125 If not there will be flagged with a Other values will not be displayed In case of an empty calibration factor try to find out the reason and if necessary contact Mindray customer servi...

Page 186: ... screen from the system menu At the Count screen run the calibrator or a normal level control at least 3 consecutive times and calculate the mean of the results Compare the obtained means to the expected means Other operations Printing new calibration factors Press PRINT to print out the current calibration factors Exiting the Calibrator screen Press MENU to exit to system menu 9 3 3 Fresh Blood C...

Page 187: ...g three or more normal blood samples prepared for calibration from the reference method or from a reliably calibrated hematology analyzer Editing calibration settings Selecting count mode At Fresh Blood screen press F1 to select the Whole Blood or Prediluted mode Selecting sample When the mode is selected press F3 to choose the fresh blood sample whose reference values you want to set Editing the ...

Page 188: ...er you have finished editing the calibration settings of Sample 1 refer to the sample handling and analysis procedures introduced in Chapter 6 Operating Your Analyzer and prepare the fresh blood samples in the selected count mode to perform the fresh blood calibration Saving calibration results If non numeric parameter values are obtained a message box will pop up to warn you as Figure 9 13 shows ...

Page 189: ...commended and the analyzer will automatically calculate the CV and calibration factor as shows Note that the CVs should be within the ranges specified in Table 9 1 Figure 9 15 Calibration with fresh blood The calculated calibration factors should be within the 75 to 125 Any calculated value that falls out of the calibration range will be flagged with a at the upper right corner Other values will n...

Page 190: ...ed by at the upper right corner Other values will not be displayed In case of an empty calibration factor try to find out the reason and if necessary contact Mindray customer service department or your local distributor For every parameter the analyzer will calculate the average calibration factor which serves as the new calibration factor only when there are at least 3 valid calibration factors a...

Page 191: ...1 and SD SD 1 of every sample 2 Run the same samples on your analyzer for the same number of times and calculate the mean MEAN 2 The MEAN 2 should be within MEAN 1 2SD If any of the samples fails to reach the criterion call Mindray customers service department or your local distributor Method two At the Count screen run the calibrator at least 5 consecutive times and calculate the means of the res...

Page 192: ... press F3 a dialog box will pop up to warn you about the data loss as Figure 9 19 shows Figure 9 19 The dialog box To switch the modes CLICK Yes and the saved data will be cleared Otherwise CLICK No to exit Printing new calibration factors Press PRINT to print out the new calibration factors Exiting the Fresh Blood screen Press MENU to exit to system menu ...

Page 193: ...em menu SELECT Calibration Manual Figure 9 20 to enter the Manual screen Figure 9 21 Figure 9 21 Manual screen The left of the Manual screen displays the available calibration modes Whole blood and Prediluted The right of the Manual screen displays the calibration factors of WBC RBC HGB MCV PLT and the time the factors are saved Use the following formula to calculate the new calibration factor mea...

Page 194: ...cibility of the calibrated parameter does not meet the requirements of Table 9 1 you must try to find out the reason and re run the calibrator after you have solved the problem If necessary contact Mindray customer service department or your local distributor for assistance Entering the manually calculated factors 1 ENTER the administrator password as introduced in Chapter 5 2 1 2 Press F2 to acti...

Page 195: ... factors Figure 9 24 A message box to confirm the new calibration factors At the Count screen run the calibrator or a normal level control at least 3 consecutive times and calculate the mean of the results Compare the obtained means to the expected means If not contact Mindray customer service department or your local distributor for assistance Other operations Printing new calibration factors Pre...

Page 196: ......

Page 197: ...ctions to maintain and troubleshoot your analyzer z Do not perform any maintenance procedures that are not described in this chapter Performing unauthorized maintenance procedures can damage your analyzer z In case of problems not specified in this manual contact Mindray customer service department or your local distributor for assistance z Only Mindray supplied parts can be used for maintenance F...

Page 198: ...yzer will remind you to perform the Probe cleanser cleaning procedure When the analyzed samples add up to 150 the analyzer will remind you to perform the Clean Probe Wipe procedure When the analyzed samples add up to 100 the analyzer will remind you to perform the E Z Cleanser Cleaning procedure When this analyzer is not to be used for two weeks perform the Prepare to Ship procedure to empty and w...

Page 199: ...alyzer 10 3 10 3 Using the Maintenance Program Press MENU to enter the system menu SELECT Service Maintenance Figure 10 1 to enter the Maintenance screen Figure 10 2 Figure 10 1 System menu Figure 10 2 Maintenance screen ...

Page 200: ...c and follow safe laboratory procedures when handling them in the laboratory z 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 z After installing new reagents let the reagents stand for a while before using them z A...

Page 201: ... reagents are irritating to eyes skin and diaphragm Wear proper personal protective equipment e g gloves lab coat etc and follow safe laboratory procedures when handling them in the laboratory z 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 ...

Page 202: ...ttom of the screen as Figure 10 4 shows When the priming is done the screen will return to the initial state Figure 10 4 Priming rinse screen 10 3 3 Lyse Prime z Samples controls calibrator 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 z After installing new reagents ...

Page 203: ... the priming progress will be displayed at the bottom of the screen as Figure 10 5 shows When the priming is done the screen will return to the initial state Figure 10 5 Priming lyse screen 10 3 4 Zap Aperture You can perform the Zap aperture procedure to unclog the apertures or prevent clogging At the Maintenance screen SELECT Zap aperture to zap the apertures and the zapping progress will be dis...

Page 204: ...o flush the apertures to unclog the apertures or prevent clogging At the Maintenance screen SELECT Flush aperture to flush the aperture and the flushing progress will be displayed at the bottom of the screen as Figure 10 7 shows When the flushing is done the screen will return to the initial state Figure 10 7 Flushing apertures ...

Page 205: ...leanser an alkaline detergent by performing the Probe cleanser cleaning procedure If your analyzer is to run 24 hours a day you should perform this procedure Follow the steps given below to do so 1 At the Maintenance screen move the cursor to Probe cleanser cleaning 2 Present the cleanser to the probe and press ENTER to aspirate the cleanser When you hear the beep and the sample probe is out of th...

Page 206: ...process as Figure 10 10 shows after which screen will return to the initial state Figure 10 10 Cleaning process To make sure this analyzer functions normally every time the accumulated analyzed samples reach 600 a message box will pop up to remind you to perform the probe cleanser cleaning procedure as Figure 10 11 shows CLICK Yes to proceed with the cleaning CLICK No to cancel the cleaning ...

Page 207: ...nd bath by performing the E Z cleanser cleaning procedure Follow the steps given below to perform the procedure 1 At the Maintenance screen move the item to E Z cleanser cleaning 2 Present the cleanser to the probe and press ENTER to aspirate the cleanser When you hear the beep and the sample probe is out of the bottle remove the cleanser This analyzer will automatically prime the bath and fluidic...

Page 208: ...n the draining is done the whole procedure is over and the screen will return to the initial state Figure 10 14 Draining the bath and fluidic lines If the accumulated analyzed samples reach 100 a message box as Figure 10 15 shows will pop up to remind you to perform the E Z cleanser cleaning procedure If you want to do so CLICK Yes Otherwise CLICK No to cancel the cleaning ...

Page 209: ...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 In case of any abnormal WBC counts or histograms you can perform the Lyse test procedure to check whether the lyse can be dispensed properly Follow the steps given below to do so 1 Unscrew and remove the retaining screws with hands or screwdriv...

Page 210: ...alyzer 10 14 Figure 10 17 Removing right plate 3 Remove the screws fixing the shielding box of the bath as Figure 10 18 shows Figure 10 18 Shielding box 4 Remove the shielding box to expose the bath as Figure 10 19 shows ...

Page 211: ...the test is done 7 If not repeat steps 5 and 6 several times If all the tries have failed check whether the lyse has run out or the lyse pickup tube is not properly connected to this analyzer If the lyse is still enough and the tube is well connected to the analyzer contact the Mindray or your local distributor for assistance 10 3 9 Clean Bath Follow the steps given below to perform the Clean bath...

Page 212: ...ults are abnormal you may do the Drain bath procedure to find out the reason Follow the steps below to do so 1 Do steps 1 to 4 of the Drain bath procedure to expose the bath 2 SELECT Drain bath to drain the bath Figure 10 21 Draining the bath 3 When the draining is done the screen will display the residual time of draining bath ...

Page 213: ...d If there is no fluid press ENTER to prime the bath with diluent as Figure 10 23 shows When the priming is done the screen will return to the initial state Figure 10 23 Priming the bath with diluent 5 If there is fluid left turn off the analyzer and call Mindray customer service department or your local distributor for assistance ...

Page 214: ... wash them off with plenty of water and immediately go see a doctor z Do the Drain Tubing procedure before relocating the analyzer You can perform the Drain tubing procedure to drain the fluidic system Follow the steps given below to do so 1 Press the appropriate arrow keys as needed to move the cursor to Drain tubing 2 Remove the diluent rinse and lyse pickup tubes from the back of the analyzer 3...

Page 215: ... cleanser to the sample probe 2 SELECT Clean Probe Wipe to start the aspiration 3 When you hear the beep and the sample probe is out of the bottle remove the cleanser 4 Unscrew and remove the retaining screws with hands or screwdrivers pointed by the arrows shown in Figure 10 25 on the right plate Figure 10 25 Removing the two screws 5 Follow the arrow shown in Figure 10 26 to push and remove the ...

Page 216: ... soaking is done wipe the bottom of the probe wipe with a probe cleanser dipped cloth that does not leave debris 9 Press ENTER to flush the block and the interior of the probe and the flushing progress is displayed on the screen as Figure 10 28 shows Figure 10 28 Flush the block and the interior of the probe 10 After the flushing is done the screen returns to the initial state When the accumulated...

Page 217: ...1 Press the appropriate arrow keys to move the cursor to Prepare to ship Remove the diluent rinse and lyse tubing from the containers following the instructions displayed on the screen 2 Press ENTER and a message box will pop up to ask you to confirm this operation as Figure 10 30 shows Figure 10 30 A message box of prepare to ship 3 CLICK No if you want to abort this operation CLICK Yes to procee...

Page 218: ... water and press ENTER to flush this analyzer with the distilled water Figure 10 32 Washing the analyzer 5 When the washing is over follow the instructions displayed on the screen to remove the rinse diluent and lyse tubing from the distilled water and press ENTER to drain the tubing again 6 Turn off the analyzer when the screen displays Turn off the analyzer 7 Wipe this analyzer dry and wrap it u...

Page 219: ...nosing analyzer errors You may follow the instructions given below to check those items Press MENU to enter the system menu and SELECT Service Status as Figure 10 33 shows to enter the Status screen as Figure 10 34 shows Figure 10 33 System menu Figure 10 34 Status screen At the Status screen you can only view the displayed status information and reference ranges without changing them ...

Page 220: ...LECT Service Self test as Figure 10 35 shows to enter the Self test screen as Figure 10 36 shows Figure 10 35 System menu Figure 10 36 Self test screen This screen can be interpreted as follows Test Groups area on the left This area displays the test groups The available self test items are divided into four groups Tubing Machine Valve and Circuit Press F1 to select the desired group The selected ...

Page 221: ...ing group as Figure 10 36 shows To conduct the following tests just SELECT the desired test and the results will be displayed later Count Time It measures the duration of a WBC and RBC count namely how many seconds it takes for the aspirated fluid flows from the first sensor to the second Aperture v It measures the voltage v over the aperture Vacuum It checks whether the vacuum system functions no...

Page 222: ... normally Elevator motor The elevator motor controls elevation of the sample probe This test checks whether the motor functions normally Print This test checks whether the recorder or printer functions normally If normal when you press ENTER the recorder or printer will print out a test page if abnormal the screen will display the corresponding error message and you can see Chapter 11 Troubleshoot...

Page 223: ...ence without making any abnormal sound it passes the test Otherwise something may be wrong with the valve 10 5 4 Testing A D Interrupt To test the A D interrupt press F1 to select the Circuit group as Figure 10 39 shows Figure 10 39 Testing A D interrupt To conduct the test SELECT A D interrupt and the test result will be displayed later ...

Page 224: ... All Settings and Other including setting discriminators system self test and updating system software which are all listed on the left of the screen All the recorded events are listed on the right of the screen by default You can press F1 to select the desired group and the right of the screen will display the events of the selected group only Every screen displays 10 events You can press or to c...

Page 225: ... event type the Times column displays how many times 1 to 255 this event occurred and if it occurred more than 255 times the excessive events will be recorded from 1 to another log file the Information column displays extra information regarding the event This analyzer can save a maximum of 1000 log files and once the maximum number has been reached the newest log will automatically cover the olde...

Page 226: ...as Figure 10 42 shows to enter the Config screen as Figure 10 43 shows Figure 10 42 system menu Figure 10 43 Config screen Every screen displays 13 items and you can press or to select the item you want to see or press PgUp or PgDn to go to the previous or next screen If you want to print out the configuration press PRINT If you want to acquire help press HELP ...

Page 227: ...lete those waiting to be processed Once something goes wrong with the printing device the task being processed will be deleted and the queued tasks will keep waiting Once the system finds the error has been removed it will resume printing and process the tasks from the first one Note that you cannot change the sequence of the queued tasks You can perform the following operations at the Print scree...

Page 228: ...on the analysis results In the accessory box there is a sample probe localizer as Figure 10 46 shows You need to use the localizer to adjust the position of the sample probe if you have replaced probe wipe or observed motor error or incorrect analysis result Also as required by regular maintenance you should use the localizer to adjust the position of the sample probe monthly Figure 10 46 Probe lo...

Page 229: ...yzer 10 33 Figure 10 48 Removing right plate 4 Press F1 to select the Machine group and SELECT Elevator motor as Figure 10 49 shows Figure 10 49 Self test screen 5 An Elevator motor window will pop up as Figure 10 50 shows ...

Page 230: ...0 50 Elevator motor window 6 Press to move the sample probe upward and press to move the probe to above the bath as Figure 10 51 shows Figure 10 51 Sample probe above the bath 7 Loose the retaining screw by a screwdriver as Figure 10 52 shows ...

Page 231: ...er into the probe wipe from the bottom as Figure 10 53 shows Figure 10 53 Using localizer 9 Insert the probe into the probe wipe until it reaches the localizer as Figure 10 54 shows Figure 10 54 Inserting sample probe into probe wipe 10 Retighten the screw to fix the probe and remove the localizer to wrap up the adjustment ...

Page 232: ...tact with the probe when working around it To replace the probe wipe 1 Refer to Chapter 10 9 and do the steps 1 to 8 2 Pull the loosen probe wipe upward to remove the probe wipe and disconnect the tubes from the probe wipe pay attention to the correspondence between the tubes and the connectors as Figure 10 55 shows Figure 10 55 Installing probe wipe 3 Install a new block and connect the tubing en...

Page 233: ... the retaining screws with hands or screwdrivers pointed by the arrows shown in Figure 10 56 on the right plate Figure 10 56 Removing the two screws 2 Follow the arrow shown in Figure 10 57 to push and remove the right plate Figure 10 57 Removing the right plate 3 Find the filter shows in Figure 10 58 ...

Page 234: ...Maintaining Your Analyzer 10 38 Figure 10 58 Vacuum filter 4 Remove the filter and take a new one from the accessory kit and install it ...

Page 235: ...recorder to print z Maintain the recorder strictly as instructed below You should maintain the recorder every two months Do as follows to maintain your recorder 1 Turn off the analyzer and cut off the power supply 2 Open the recorder door and take out the recorder paper 3 Gently wipe the roller from left to right using cotton swabs 4 Roll the roller and repeat step 3 to clean off all debris and st...

Page 236: ...Maintaining Your Analyzer 10 40 Figure 10 59 Heating part of recorder head and roller See the figure above to find the heating part of the recorder head and the roller when the recorder door is opened ...

Page 237: ...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 z Running samples in presence of error messages may lead to misleading results If any error message occurs during sample analysis remove the error first and then re run the sample z Unless otherwis...

Page 238: ...he power cord connection 2 Check the fuse 3 Check the electrical outlet Liquid drips from analyzer inside Damaged pump hose or blocked filter 1 Turn off the power and wipe the analyzer dry 2 Call Mindray customer service department or your local distributor for assistance Recorder does not work 1 Recorder paper is jammed 2 Something is wrong with the circuit 1 Remove the jammed paper 2 If the prob...

Page 239: ...ctual temperature is within the pre defined range and the problem remains contact Mindray customer service department or your distributor Blank abnormal 1 Contaminated diluent diluent lines or bath 2 Expired diluent 1 Check if the diluent is contaminated or expired 2 Enter the Count screen and press the aspirate key to do the startup procedure 3 If the problem remains enter the Service Maintenance...

Page 240: ...BC clog 1 Clogged the aperture 2 Inappropriate WBC count time setting 3 Solenoid valve error 1 Enter the Service Maintenance screen Zap and flush the aperture as instructed by Chapter 10 3 4 and 10 3 5 2 Enter the Setup Settings Count screen and record the WBC count time Then enter the Service Self test screen and test the actual WBC count time as instructed by Chapter 10 5 1 3 If the difference b...

Page 241: ...ng 1 Check if the diluent or rinse has run out If so change a new container of diluent or rinse as instructed in Chapter 4 4 1 2 Check the connection of the diluent and rinse pickup tube If necessary reconnect and tighten them as instructed by Chapter 4 4 1 3 If the problem remains adjust the WBC count time as instructed by Chapter 5 3 5 4 If the problem remains contact Mindray customer service de...

Page 242: ... seconds but consistent enter the Setup Settings Count and reset the RBC count time Then enter the Service Self test screen and test the actual RBC count time as instructed by Chapter 10 5 1 to confirm the difference is less than 2 seconds 8 If the problem remains contact Mindray customer service department or your local distributor RBC bubbles 1 Diluent or rinse running out 2 Loose tube connectio...

Page 243: ...stomer service department or your local distributor Printer out of paper Printer paper running out or not properly installed 1 Check if there is printer paper 2 Check if the printer paper is well installed Printer offline Poor connection between the printer and the analyzer Check if the printer is well connected to the analyzer Recorder com error 1 Poor connection between the recorder and the anal...

Page 244: ...4 4 1 2 If not reset the expiration date as instructed in Chapter 5 3 1 Rinse expired Expired rinse or wrong expiration setting 1 Check if the rinse has expired If so change a new container of rinse as instructed by Chapter 4 4 1 2 If not reset the expiration date as instructed in Chapter 5 3 1 Lyse expired Expired lyse or wrong expiration setting 1 Check if the lyse has expired If so change a new...

Page 245: ... Mindray customer service department or your local distributor Rotation motor error 1 Jammed sample probe 2 Poor contact of the signal line 3 Damaged motor 4 Poor connection between the drive board and the CUP board 5 Malfunctioning photo coupler 1 Open the front door and check if the sample probe is jammed 2 Enter Service Self Test Machine screen to test the rotation motor as instructed by Chapte...

Page 246: ... Mindray customer service department or your local distributor Pressure error The pressure inside the pressure chamber does not reach the expected value within the given time 1 Check whether the external tubing is pressed 2 If not enter Service Self test Tubing screen to check the pressure as instructed by Chapter 10 5 1 3 If the test result is normal the error will be removed 4 If the problem rem...

Page 247: ...artment or your local distributor Dynamic memory error Something is wrong with the analyzer s memory Turn off the power and contact Mindray customer service department or your local distributor 12 V power error Something is wrong with the power board Shut down the analyzer and contact Mindray customer service department or your local distributor 12 V power error Something is wrong with the power b...

Page 248: ......

Page 249: ...ain 5 13 other 5 25 Print comm 5 7 reagent 5 5 reference range 5 20 CV definition 7 16 formula 7 16 diluent connection 4 5 definition 2 13 prime 10 4 dilution 3 3 dimensions B 5 drain tubing 10 18 environment B 5 error 12V power error 11 11 12V power error 11 11 56V power error 11 11 A D error 11 10 ambient temp abnormal 11 3 barcode com error 11 7 barcode error 11 7 blank abnormal 11 3 diluent em...

Page 250: ...ating range B 2 humidity B 5 ID 6 9 Impedance Principle 3 1 installation requirement 4 2 LCD 2 6 leukocyte granulocyte 2 2 lymphocyte 2 2 mid sized cell 2 2 linearity range PLT B 3 RBC B 3 WBC B 3 Lymph definition 3 7 formula 3 7 Lymph definition 3 6 formula 3 6 lyse connection 4 7 definition 2 13 lyse test 10 13 maintenance system 10 3 MCH definition 3 10 formula 3 10 MCHC definition 3 10 formula...

Page 251: ...ent 3 9 operating range B 2 RDW CV 3 10 reagent connection 4 5 required 2 13 recorder format 5 7 install paper 4 9 reference range 5 20 rinse definition 2 14 prime 10 5 sample analysis 6 9 review 7 1 sample probe adjust 10 32 sample probe localizer 10 32 shutdown 6 28 specification B 1 system self test 10 24 status 10 23 table sample 7 7 searched 7 29 throughput B 2 transmission at QC table screen...

Page 252: ......

Page 253: ...ers and histograms Parameter Abbreviation Default White Blood Cell or leukocyte WBC 109 L Red Blood Cell or erythrocyte RBC 1012 L Hemoglobin Concentration HGB g L Platelet PLT 109 L WBC histogram WBC Histogram RBC histogram RBC Histogram PLT histogram PLT Histogram Table B 2 Parameters derived from histograms Parameter Abbreviation Default Lymphocyte percentage Lymph Mid sized cell percentage Mid...

Page 254: ...centration MCHC g L Mean Platelet Volume PCT B 4 Sampling Features B 4 1 Sample volumes required for each analysis Whole Blood Mode vein blood 13 µL Prediluted Mode capillary blood 20 µL B 4 2 Aperture size Diameter Length Aperture 80 µm 70 µm B 4 3 Throughput Less than 120 seconds analysis B 5 Performance specifications B 5 1 Operating range Parameter Operating range WBC 109 L 0 0 to 499 9 RBC 10...

Page 255: ...0 0 to 99 9 RBC 1012 L 0 0 to 9 99 HGB g L 0 to 300 PLT 109 L 0 to 999 B 5 4 Carryover Parameter Carryover WBC 0 5 RBC 0 5 HGB 0 5 PLT 1 B 5 5 Reproducibility with normal level control Parameter Condition CV WBC 109 L 4 0 to 15 0 3 0 RBC 1012 L 3 00 to 6 50 2 0 HGB g L 100 to 180 2 0 MCV fL 70 to 100 1 0 PLT 109 L 200 to 500 5 0 B 6 Input Output Device z Use the specified devices only ...

Page 256: ...nt quality and operating life of the recorder it is recommended that you purchase the recorder paper from the analyzer manufacturer B 6 7 Printer optional Epson LQ300k II Epson 630K B 6 8 Interfaces A keyboard interface Two RS 232 interfaces maximum transmission distance 12 meters A parallel port for printer or floppy disk drive A power supply for the floppy disk drive only to be used with the pow...

Page 257: ...1997 A1 1998 A2 2001 A3 2003 EMS is compliance with experiment environment EMC is compliance with Class A B 9 Sound Maximal sound 65 dB B 10 Operating environment Operating temperature 15 to 30 Relative humidity 30 to 85 Atmospheric pressure 60 kPa to 110 kPa B 11 Storage environment Ambient temperature 10 to 40 Relative humidity 10 to 93 Atmospheric pressure 50 kPa B 12 Dimensions Depth Width Hei...

Page 258: ...Appendices B 6 38 6 cm 32 2 cm 43 7 cm B 13 Weight Less than 23 kg B 14 Contraindications None ...

Page 259: ...ace power and environmental requirements listed in Chapter 4 and Appendix B must be met Establishing and maintaining proper grounding cannot be overemphasized C 1 2 Limitations Whenever the results are outside the normal limits it is recommended that the laboratory following whatever written protocol is in place for validating results If an error occurs the analyzer displays the corresponding erro...

Page 260: ... in the laboratory z 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 z Do not place the analyzer in a flammable or explosive environment z Dispose of reagents waste samples consumables etc according to government re...

Page 261: ...customer service department or your local distributor z Use only specified recorder paper Otherwise it may cause damage to the recorder head or the recorder may be unable to print or poor print quality may result z Never pull the recorder paper with force when a recording is in process Otherwise it may cause damage to the recorder z Do not leave the recorder door open unless you install paper or r...

Page 262: ...arton and all the packing materials as they can be used for packaging if analyzer must be reshipped z Use the specified reagents z Never use expired reagents z To prevent contamination tighten the container caps when the installation is finished z Use the printer and scanner of the specified model z Store and use the reagents as directed by instructions for use of the reagents z When you have chan...

Page 263: ... clogging or bubbles during the analysis the corresponding error messages will be displayed in the error message area and the results of all the related parameters will be invalidated See Chapter 11 Troubleshooting Your Analyzer for solutions z The result of the background check will not be flagged z Select proper reference range as instructed in Chapter 5 3 6 before running the samples Otherwise ...

Page 264: ...se the calibrator z Keep dust from the prepared diluent z Do the Drain tubing procedure before relocating the analyzer z 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 z When installing the analyzer our au...

Page 265: ...azard z Samples controls calibrator 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 ...

Page 266: ......

Page 267: ... proper communication protocol that matches the data management software configured z To adjust the communication protocol of the analyzer please contact Mindray customer service department The BC 2800 can transmit the sample data and QC data to an external computer a host through its RS 232 serial port The transmission can be conducted either automatically or through the command of the operator a...

Page 268: ...igure D 1 Figure D 1 DB9 connecter Pin description DCD Carrier Detect RXD Receive Data TXD Transmit Data DTR Data Terminal Ready GND Signal Ground DSR Data Set Ready RTS Request to Send CTS Clear to Send RI Ring Indicator The BC 2800 communicates with a host through serial port 2 using Pin2 Pin 3 and Pin 5 The maximum transmission distance is 12 meters ...

Page 269: ... 0x41 B 0x42 C 0x43 0x30 0x39 0x2A If the Lot No Month Day Year are empty in QC Edit menu the 2A Hex will be transmitted to the host For all the data formats if the data are marked then 2A Hex will be transmitted to the host L1 Region to L8 Region are LI to L8 of eight histogram discriminators as shown in Figure D 2 Figure D 2 L1 to L8 ...

Page 270: ...analyzer maximum two ENQ 05 Hex will be sent 3 The analyzer then sends Body of text EOT 04 Hex ETX 03 Hex 4 Disconnection BC 2800 sends an ETX 03 Hex then waits 4 seconds for the external computer to respond If no response is received one more ETX 03 Hex is sent BC 2800 waits 4 seconds before giving up and gives alarm of communication error If the external compute responds ACK the transmission is ...

Page 271: ...y Year Hour Minutes Seconds WBC 109 L Lymph 109 L Mid 109 L Gran 109 L Lymph Mid Gran RBC 1012 L HGB g L MCHC g L MCV fL MCH pg RDW CV HCT PLT 109 L MPV fL PDW PCT RDW SD fL Reserved Rm R1 R2 R3 R4 Pm Ps Pl L1 Region L2 Region L3 Region L4 Region L5 Region ...

Page 272: ...ETX D 3 3 Standard QC Data Format If handshake is enabled ENQ If handshake is disabled STX Body of the text start Text Identifier B Version The number of parameters Number of the parameters having format descriptions Parameter format File No Lot No Month Day Year WBC 109 L RBC 1012 L HGB g L PLT 109 L Lymph 109 L Lymph Gran 109 L Gran HCT MCV fL MCH pg MCHC g L WBC Limit 109 L RBC Limit 1012 L HGB...

Page 273: ...f handshake is enabled ETX D 3 4 Running QC Data Format If handshake is enabled ENQ If handshake is disabled STX Body of the text start Text Identifier C Version The number of parameters Number of the parameters having format descriptions Parameter format Month Day Year Hour Minutes WBC 109 L RBC 1012 L HGB g L PLT 109 L Lymph 109 L Lymph Gran 109 L Gran HCT MCV fL MCH pg MCHC g L Body of the text...

Page 274: ...hapter 5 3 2 D 4 2 Transmission at Count Screen If the auto transmission function is on once the analysis is done the analyzer will automatically transmit the results to the external computer If the auto transmission function is off you can only transmit the results manually at the Review screen D 4 3 Transmission at the Review Screen Select the results you want to transmit and transmit them to th...

Page 275: ... proper communication protocol that matches the data management software configured z To adjust the communication protocol of the analyzer please contact Mindray customer service department The BC 2800 can transmit the sample data and QC data to an external computer a host through its RS 232 serial port The transmission can be conducted either automatically or through the command of the operator a...

Page 276: ...igure E 1 Figure E 1 DB9 connecter Pin description DCD Carrier Detect RXD Receive Data TXD Transmit Data DTR Data Terminal Ready GND Signal Ground DSR Data Set Ready RTS Request to Send CTS Clear to Send RI Ring Indicator The BC 2800 communicates with a host through serial port 2 using Pin2 Pin 3 and Pin 5 The maximum transmission distance is 12 meters ...

Page 277: ...tion command from analyzer after data transmission Special symbols The start and end signs of massage and data segment Field name Coding Description MS 0x05 Message start sign ME 0x0a Message end sign SE 0x04 End sign field of metadata Each metadata ends with SE FE 0x08 End sign field of attribute data Each attribute data ends with FE Special delimiter Delimiter sign between message body data segm...

Page 278: ...smission error 2 The external computer must respond by sending an ACK 06 Hex 3 After the ACK 06 Hex is received the analyzer then sends data block 4 After the sending the BC 2800 sends an ETX 0F Hex then waits 4 seconds for the external computer to respond If no response is received one more ETX 0F Hex is sent The BC 2800 waits 4 seconds before giving up and gives alarm of communication error E 3 ...

Page 279: ...east two R flags R1 Indicates abnormality on the left side of the lymphocyte hump R2 Indicates abnormality between the lymphocyte hump and the mid sized cell area R3 Indicates abnormality between the mid sized cell area and the granulocytes R4 Indicates abnormality on the right side of the neutrophilic granulocyte hump Pm Indicates blur demarcation between the platelet and red blood cell area Ps I...

Page 280: ...13 Ch ecker Sample information WBC FD1 FD2 FD3 FD4 FD5 Val Low High Unit Flag White blood cell count Lym ph The same with those of WBC Lymphocytes number Mid The same with those of WBC Mid sized cell Gran The same with those of WBC Granulocyte Lym ph The same with those of WBC Lymphocytes percentage Mid The same with those of WBC Mid sized cell percentage Gran The same with those of WBC Granulocyt...

Page 281: ...tcrit Alar mFlag F D1 F D2 F D3 F D4 F D5 F D6 F D7 F D8 R m R 1 R 2 R 3 R 4 P m P s P 1 Histogram alarm SepL ine FD1 FD2 FD3 FD4 SepWB CLyLeft SepWB CLyMid SepWB CGranMid SepWB CGranRight FD5 FD6 FD7 FD8 SepRB CLeft SepRB CRight SepPLT Left SepPLT Right Discriminator information WBC Histo FD1 FD2 FD3 DataLen MeteDataLen WHistoData WBC Histogram RBC Histo FD1 FD2 FD3 DataLen MeteDataLen RHistoData...

Page 282: ...with those of WBC Hemoglobin Concentration PLT The same with those of WBC Platelet count Lymph The same with those of WBC Lymphocytes number Lymph The same with those of WBC Lymphocytes percentage Gran The same with those of WBC Granulocyte Gran The same with those of WBC Granulocyte percentage HCT The same with those of WBC Hematocrit MCV The same with those of WBC Mean Corpuscular Volume MCH The...

Page 283: ... Unit White blood cell count RBC The same with those of WBC Red Blood Cell count HGB The same with those of WBC Hemoglobin Concentration PLT The same with those of WBC Platelet count Lymph The same with those of WBC Lymphocytes number Lymph The same with those of WBC Lymphocytes percentage Gran The same with those of WBC Granulocyte Gran The same with those of WBC Granulocyte percentage HCT The sa...

Page 284: ...Appendices E 10 Hemoglobin Concentration ...

Page 285: ...creen If the auto transmission function is on once the analysis is done the analyzer will automatically transmit the results to the external computer If the auto transmission function is off you can only transmit the results manually at the Review screen E 4 3 Transmission at the Review Screen Select the results you want to transmit and transmit them to the external computer as instructed by Chapt...

Page 286: ...P N 2800 20 28795 2 0 ...

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