Customizing the Analyzer Software 5-20 Click the radio button to select one of the following ways of communication: Serial Port Network Interface When you select “Network Interface”, you can choose to check the “Terminal Software as the Server” check box if needed. Network Setup Enter the correct IP address and port into the “IP address” and “Port” text boxes. Serial Port Setup If you select to communicate through “Serial Port”, you can click the “Serial Port” pull-down list to choose the appropriate one. You can also view the baud rate configured for the serial port communication. Protocol Setup Select protocol type Click the “Protocol Type” pull-down list to select one of the following communication protocols: HL7 15ID+GBK 15ID+UTF-8 Select protocol version Click the “Version” pull-down list to select the desired version of communication protocol.
Customizing the Analyzer Software 5-21 Set ACK Synchronous Communication Click the “ACK Synchronous Communication” check box to activate the function. When the function is activated, you can click the up and down arrows to modify the default ACK Timeout value or re-enter it into the text box. Transmission Mode You can click the check boxes below to activate the corresponding communication settings: 2-Way LIS/HIS Communication Transmit as Print Bitmap Data Auto Communication Only communicate after validation Histogram and Scattergram Transmitted as You can click the pull-down list to select how to transmit histograms and scattergrams: Not transmitted Bitmap Data Lab Info. Setup (“Setup” > “General Setup” > “Lab Info.”) An operator can view lab information from this screen, while an administrator can enter, save and view lab information.
Customizing the Analyzer Software 5-22 The Lab Information includes: Information Details Hospital Name Name of the hospital where the analyzer is installed Lab Name Name of the laboratory where the analyzer is installed Supervisor Name of the people in the laboratory who is in charge of the use of the instrument Contact Info. Contact information of the supervisor Zip Code Zip code of the hospital Responsible Engineer Name of the responsible service engineer Service Contact Info. Contact information of the responsible service engineer Comments You can enter any comments related to the laboratory Analyzer Model Model of the analyzer Analyzer SN Cannot be edited. The serial numbers of all analyzers that have been connected to this software are listed here by default Date of Installation The default installation date is the date on which software of the PC was installed, which cannot be later than the current system date 5.3.2 Para. Setup (Administrator) ("Setup" > "Para. Setup") You can click the following tabs to go to the corresponding setup screens and complete the desired configurations.
Customizing the Analyzer Software 5-23 RUO Para. Setup (“Setup” > “Para. Setup” > “RUO Para. Setup”) You can click the following check boxes to activate the corresponding RUO parameter settings: Display "*" flags Display Declaration Print RUO Parameters Print "*" flags The default declaration is:” * For research use only, not for diagnostic use.” You can edit the content of declaration in the “Print Declaration” if needed. NOTE If the “Display “*” flags” check box is not selected, the “Display Declaration” check box will gray out and cannot be selected. If the “Print RUO Parameters” check box is selected, it is recommended to select the “Display “*” flags” check box to ensure that the reader of the printout could identify the RUO parameters. If the “Print RUO Parameters” check box is not selected, the “Print “*” flags” check box will gray out and cannot be selected. The RUO-parameter-related settings apply to the display and print of RUO parameters of all samples, before or after the setup is completed. Microscopic Para. Setup (“Setup” > “Para. Setup” > “Microscopic Para. Setup”)
Customizing the Analyzer Software 5-24 Select sample type You can click the “Sample Type” pull-down list to select the sample type you set in the “Data Dictionary” setup screen (see 5.3.4 Data Dictionary ("Setup" > "Data Dictionary")). Add new parameter Click the “New” button to add a new row in the table, and then you can enter the name of the parameter in the row. Delete Select a row in the table, click the “Delete” button to delete the parameter. Adjust the order Select a row in the table, click the Order adjusting buttons on the right to move it up/down or to the top/bottom. Editing parameter name Click a parameter name in the table to edit the name. NOTE You can add up to 40 microscopic parameters. The reconfigured setup will not be applied to sample records which already have microscopic results saved, but only applied to sample records with unsaved microscopic results and records attained after the new setup is applied. Custom Para. Setup (“Setup” > “Para. Setup” > “Custom Para. Setup”) If you want to print the parameter results obtained from other measuring device or through manual measurement together with the BC-6800 results, you can configure on the screen.
Customizing the Analyzer Software 5-25 Add a new parameter 1. Click the “New” button to add a new row. 2. Enter desired information, like “Abbreviation”, “Para. Name”, “Default”, “Para. Unit”, etc. 3. If needed ,tick the “Add to All Reports” box to add this new parameter to all reports. NOTE The abbreviations of custom parameters shall not be the same as any abbreviation of the report parameter of the analyzer. The “Analysis Parameters” are displayed at the bottom of the screen for your reference. The abbreviation of a custom parameter cannot be null. Set up reference value and upper/lower limits You can set up to 15 reference groups and define the corresponding target and upper/lower limits. Click the corresponding cells to edit the settings. Delete Click to select a custom parameter in the table, and then click “Delete” to delete the parameter. 5.3.3 Access Setup ("Setup" > "Access Setup") The access setup provides different access levels with different functions.
Customizing the Analyzer Software 5-26 Operator Changing password The current user logged in can modify his/her own password. 1. Select the current user from the table, and then click “Change Password”. 2. Enter the required information in the text boxes. 3. Click “OK” to save the change and close the dialog box. NOTE The password can not be null and up to 12 characters can be entered.
Customizing the Analyzer Software 5-27 Administrator Change password The current user logged in can modify his/her own password. 1. Select the current user from the table, and then click “Change”. 2. Enter the required information in the text boxes. 3. Click “OK” to save the change and close the dialog box. NOTE The password can not be null and up to 12 characters can be entered.
Customizing the Analyzer Software 5-28 Add a new user 1. Click the “New” button. 2. Enter the “User ID”, “Name”, “Password”, and “Confirm Password”. 3. Select one of the following access levels from the “Access Level” pull-down list: Administrator Operator 4. Click the “Yes” radio button to display the User ID on the login screen, or Click “No” not to display. 5. Enter “Comments” if needed. 6. Click “OK” to save and exit. NOTE The user ID cannot be null and up to 12 characters can be entered. The password can not be null and up to 12 characters can be entered. The name cannot be null and up to 20 characters can be entered. The comments can be null and up to 30 characters can be entered. Edit user information 1. Select a user, and then click “Edit”.
Customizing the Analyzer Software 5-29 2. Modify the “User ID”, “Name” and/or “Comments” by editing the text in the box(es) as needed. NOTE The default administrator user ID (“admin”) can not be edited. 3. Reselect the “Access Level” if needed. 4. Enable or disable “Login Screen Display” of the User ID if needed. 5. Click “OK” to save the change and close the dialog box. NOTE The user ID cannot be null and up to 12 characters can be entered. The name cannot be null and up to 20 characters can be entered. The comments can be null and up to 30 characters can be entered. Reset password An administrator can reset the password (to be the same as the user ID) of all users at the operator and administrator access level Select a user and then click the “Reset Password” button to reset the password to be the same as its user ID. Delete user An administrator can delete all users at the operator and administrator access level. Select a user and then click “Delete” to delete it.
Customizing the Analyzer Software 5-30 NOTE The current user logged in cannot be deleted. Adjust the order Select a user in the table, and click the Order adjusting buttons on the right to move it up/down or to the top/bottom. Authorize functions/accesses An administrator can authorize the users of the operator access level to perform certain operations or set up certain functions. To authorize the access to an operator: Find the authority you want to authorize, and check the corresponding box(es) (“PC Workstation” (DMU) and/or “Analyzer End” (SPU)). E.g. if you tick both the “PC Workstation” and “Analyzer End” check boxes of the “Delete Sample” operation, all users of the operator access level are able to delete sample both at the PC and analyzer ends after the setting is saved. 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") You can set up the information provided as options in the pull-down lists of patient information area of the “Report” screen (as for “Sample Type”, it also includes the pull-down lists in the “Microscopic Exam.” tab of the “Review” screen and in the “Microscopic Para. Setup” screen), in order to support quick entry. E.g. if there is a shortcut key of “Department” whose information are as follows: Code: 1; Department: Outpatient; Shortcut Code: OT When you are entering outpatient for the “Department” field of the worklist, you can select “Outpatient” from the pull-down list; or you can enter the code “1” or shortcut code “OT”, and the “Outpatient” option will be popped up in the pull-down list for you to select. The shortcut codes set up on this screen will be displayed in the pull-down lists of patient information text boxes.
Customizing the Analyzer Software 5-31 Add a shortcut code 1. Select the desired data dictionary item from the left. 2. Click “Add Shortcut Key”, and a new row will be added in the list on the right. 3. Enter the information needed for the new row. E.g. to enter the information of a shortcut key for the “Department”: 1) Enter a numeric “Code” (mandatory, up to 9 digits, and can not be the same with existed ones) 2) Enter the finial entry of the “Department” filed (mandatory, up to 20 characters, and can not be the same with existed ones) 3) Enter the “Shortcut code” (optional, up to 20 characters). 4) Enter the “Comments” if needed (optional). Edit a shortcut code 1. Select the desired data dictionary item from the left. 2. Select the row of the shortcut code you want to edit. 3. Click the column you want to edit one by one and modify NOTE You can only edit the “Shortcut Code” and “Comments” columns of the default items. Delete shortcut code 1. Select the desired data dictionary item from the left. 2. Select the row of the shortcut code you want to delete. 3. Click “Delete Shortcut Key” to delete it.
Customizing the Analyzer Software 5-32 NOTE You cannot delete the default items. 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") Select one of the following “System of Units” from the pull-down list on top left: Customize China International US Canada Netherlands UK If "Customize" is selected, you can select the desired units from the pull-down lists of the “Unit” column. Click the "Restore" button to restore the default units for “Customize”. 5.3.6 Ref. Ranges (Administrator) ("Setup" > "Reference Ranges") The “Ref. Ranges” screen provides 5 factory reference groups for your selection. In addition,
Customizing the Analyzer Software 5-33 you can set up to 10 custom reference groups. Edit custom reference group To edit a custom reference group, click the cells of custom reference groups in the table on the left and enter information like name of the reference group and age range directly and select the units for the age limits from the pull-down lists. Select a custom reference group; click the “Restore” button to the right of the “Set to Default” button to restore the age setting of the reference group. NOTE The information like name, upper/lower age limit and gender of the factory reference group cannot be changed. The input range of age is [0,999]. Set default reference group Select a reference group and then click “Set to Default” to set it as the default reference group. Modify/Restore reference range(s) To modify the reference range of a reference group, select the group from the reference group list on the left, and then click the cells of upper and lower limits in the table and re-enter the values. To restore the reference ranges to default, click the “Default” button on top right of the screen.
Customizing the Analyzer Software 5-34 Automatic matching of custom reference groups If you entered the age and/or gender information in the worklist, the analyzer will automatically find the matching reference group (first in the factory groups and then the custom groups) and use the corresponding reference ranges. If you want the analyzer to only find the appropriate reference group in the custom ones, check the “Only match custom ref. groups” check box. 5.3.7 Reexam Rules (Administrator) ("Setup" > "Reexam Rules ") Reexam means to reexamine the analyzed samples whose results match certain conditions. The way to reexam is determined by the laboratory procedure, which may include re-analyze on the analyzer, smear review, etc. You can set up a rule file of reexam rules in the "Reexam Rules” screen. The analyzer will check the sample results and information based on the applied rules to give reexam suggestions. The rule file of 31 default rules provided by the manufacturer is displayed on the "Reexam Rules” screen by default. Introduction to the screen The reexam rule setup screen consists of the rule list area, rule file button area rule editing area and rule button area (from left to right and top to bottom). Create a rule file 1. Click the “New File” button on the right of the rule table.
Customizing the Analyzer Software 5-35 2. Click “OK”, the default rule table will be overwritten by a blank table. Edit a rule file Add a new rule 1. Click the “Add” button at the bottom of the screen to add a new rule to the table. 2. Enter the “Rule Name” in the rule editing area. 3. Specify the “Gender” from the pull-down list if needed. 4. Specify the age range by entering the ages and selecting the units if needed. 5. Enter the desired rules in the “Parameter Rules” field; Or click the “Setup” button to the right of the “Parameter Rules” field, and then edit the rule in the pop-up box shown below.
Customizing the Analyzer Software 5-36 Click “OK” after finish editing to close the dialog box. And the rule will be displayed in the “Parameter Rules” field. 6. If you want to include “Flagging Rules”, you shall select “AND” or “OR” in the “Relation” pull-down list to define the relationship between the two group of rules. 7. Enter the desired rules in the “Flagging Rules” field; Or click the “Setup” button to the right of the “Flagging Rules” field, and then edit the rule in the pop-up box shown below.
Customizing the Analyzer Software 5-37 Click “OK” after finish editing to close the dialog box. And the rule will be displayed in the “Flagging Rules” field. 8. Click other rules in the rule list (if there are no other rules, click “Add” or “Copy”) to save the setup. Edit rules Select the rule and edit its content in the box below. When editing completes, click other rules in the rule list (if there are no other rules, click “Add” or “Copy”), the change will be saved automatically. Apply rule(s) Click the check box(es) in the “Apply” column of the rule list to apply the corresponding rule(s). Adjust order of the rules Select rules first and then click the buttons in the order adjusting area to move the rules up/down or to the top/bottom. Delete a rule 1. Select the rule you want to delete and then click “Delete”, a dialog box below will pop up.
Customizing the Analyzer Software 5-38 2. Click “OK” to delete the rule and close the dialog box. Copying rules 1. Select the rule you want to copy and then click “Copy”, a dialog box below will pop up. 2. Enter name of the new rule into the “Rule Name” field. 3. Click “OK” to save the rule and close the dialog box. Import a rule file You can also import custom rules per the following procedure: 1. Click the “Import” button to the right of the rule table, a dialog box below will pop up. 2. Click “OK” and browse to the rule file to be imported in the pop-up dialog box. 3. Click “Open”, the rules of the new rule file will be displayed in the rule list area. Export a rule file 1. Click the “Export” button to the right of the rule table. 2. Browse to the directory you want to export the rule file in the pop-up dialog box. 3. Click “Save” to export the rule file.
Customizing the Analyzer Software 5-39 Restore the default rule file 1. Click the “Restore Default Rules” button to the right of the rule table, a dialog box below will pop up. 2. Click “OK”, the dialog box will be closed and the rules of the default rule file will be displayed in the rule list area. 5.3.8 Flag Setup ("Setup" > "Flag Setup") The flag setup screen provides a list of all flagging rules. When a result meets the requirement of the rule, the corresponding flag will be displayed. You can edit the flagging rules based on the needs and related procedure of your laboratory. Edit a flagging rule 1. Click to select a rule from the flagging rule table, and the name and rule will be displayed under the table. 2. If there is only one rule in the “Flagging Rules” field, click the value in the rule and edit. If there are more than one rule in the “Flagging Rules” field, tick to select one of the rules. Then click the value in the rule and edit. 3. Click another rule in the table, a dialog box will pop up asking you whether to save the change. Click “Yes” to save the change.
Customizing the Analyzer Software 5-40 Restore default rule 1. Select a rule which has been edited from the table. 2. Click the “Restore” button to restore the default value. 3. Click another rule in the table, a dialog box will pop up asking you whether to save the change. Click “Yes” to save the change. 5.3.9 Screen Display ("Setup" > "Screen Display ") You can set up the style of screen display from this screen. Click the radio buttons to select the way of menu display and font size.
6-1 6 Operating Your Analyzer 6.1 Introduction This chapter provides step-by-step procedures for operating your analyzer on a daily basis. A flow chart presenting the common daily operating process is shown below. Initial Checks Power on Daily Quality Control Sample Collection and Handling Run Samples Shutdown Switch on the analzyer and open PC software Switch off the analyzer and close PC software
Operating Your Analyzer 6-2 6.2 Initial Checks Perform the following checks before turning on the analyzer. Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory. WARNING Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations. The 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. 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. Keep your clothes, hair and hands away from the moving parts to avoid injury. NOTE You should only use the Mindray-specified reagents. Store and use the reagents as instructed by instructions for use of the reagents. Before using the analyzer, make sure reagents are properly connected. After installing a new container of reagent, keep it still for a while before use. Checking the waste container Check and make sure the waste container is empty. Checking tubing and power connections Check and make sure the reagents, waste and pneumatic unit tubes are properly connected and not bent. Check and make sure the power cords of the analyzer and the pneumatic unit are properly
Operating Your Analyzer 6-3 plugged into the power outlet. Checking the printer (optional)
Operating Your Analyzer 6-4 6.3 Startup Start up the PU and SPU 1. Place the power switch at the back of the PU in the ON position (I). NOTE Since the pneumatic unit is controlled by the analyzer, the power switch of the pneumatic unit can be kept in the ON position (I). 2. Place the power switch at the left side of the SPU in the ON position (I). The power indicator light will be on. 3. Press the power button to turn on the analyzer. The power indicator will turn from orange to green. 4. The analyzer will automatically perform the self-test procedure, background cycle and initialize the systems. NOTE Time needed for initializing the fluidic systems depends on how the analyzer was previously shut down. Background check of the analyzer measures the particle interference and electrical interference. If the first background result obtained during the fluidic initialization process is out of the specified range, the analyzer will perform background check again. The sample ID corresponds to background check result is “0”. The analyzer does not flag background check result with H/L or suspect flag. 5 After the initialization process, you will go to the sample analysis screen.
Operating Your Analyzer 6-5 NOTE The system determines your access level (operator or administrator) base on the password you entered and provides different function on each screen per the access level. To switch the access level, tap “Logout” from the main menu. Enter the desired password in the popup dialog box, and then tap “OK” to log in. Switch user 1. Tap “Menu” > “Logout”. 2. Tap “Yes”.
Operating Your Analyzer 6-6 3 Enter the correct password in the “Password” box, and then tap “OK”. Start up the external PC and run software of the PC: 1. Power on the PC and the display. 2. After entering the operation system, double click the icon “BC-6800 Auto Hematology Analyzer” to run the software installed. 3 When the following startup screen shows, select a desired user displayed on the screen and enter the password, or click “Other Users” to enter the “User ID” and “Password”.
Operating Your Analyzer 6-7 4. Click the button or press “Enter”. NOTE If you fail to launch the software after tried for many times, please contact Mindray customer service department or your local distributor. After the startup procedure completes, check if the date/time on the analyzer and the PC are correct. 1-12 characters are allowed for user name and password; Chinese characters are not allowed; neither user name nor password can be null. 5. When initialization completes, if there is any sample not run or failed to be analyzed successfully in the worklist, a dialog box will pop up.
Operating Your Analyzer 6-8 6. Click “Yes” to save the samples in the worklist; they will be analyzed later on; or click “No” to delete the samples from the worklist; they will not be analyzed. NOTE If error occurs during the initialization process (e.g. background result exceeds the specified range), the analyzer will send alarm, see Chapter 11 Troubleshooting for solutions. Refer to Appendix B Specifications for the background range of each parameter. The system determines your access level (operator or administrator) base on the password you entered and provides different function on each screen per the access level. If user switching is necessary, CLICK the “Logout” icon at the “Main” screen. Enter the desired user name and the password into the popup dialog box and CLICK the “Ok” button to log in. Running sample with the background abnormal error present will lead to unreliable results. There is no restriction on the launching order of the analyzer software and PC software.
Operating Your Analyzer 6-9 6.4 Daily Quality Control Before running any samples, run the controls. See Chapter 8 Using the QC Programs for details.
Operating Your Analyzer 6-10 6.5 Entering the “Count” Screen Tap “Menu” →"Sample Analysis” to enter the screen below. NOTE If the blood mode is switched from the “WB” to “PD” or the sampling mode is changed, the analyzer will switch modes automatically and give the prompt on the screen. Menu button Tap the MENU button on the top left of the screen to open the system menu. Tap a menu option to open the submenu or enter the corresponding screen or dialog box. Menu Utility Buttons Sample info. area Button area Analysis result area Error message System time
Operating Your Analyzer 6-11 Utility buttons Name Icon Function Count Tap to enter the "Count" screen Table Tap to enter the "Table" Review screen QC Tap to enter the "QC" screen Reagent Tap to enter the "Reagent" Setup screen Service Tap to enter the "Service" screen DILUENT When the mode is OV-PD, tap "Diluent" to dispense diluent Analysis result area This area displays the analysis result of the current sample (including flag messages, histograms, scattergrams, etc.). Sample information area This area displays the information of the current and the next sample. Button area Tap buttons in this area, the corresponding screen or dialog box will pop up, or the corresponding function will be realized. Error information area When error occurs, this area displays the error message. System time This area displays the current system time.
Operating Your Analyzer 6-12 NOTE Background check of the analyzer measures the particle interference and electrical interference. The sample ID corresponds to background check result is “0”. Running sample with the presence of the background abnormal error will lead to unreliable results. If error occurs during the startup process, the error information will be displayed in the error information area after you log in. You should solve the error first before performing any operation. See Chapter 11 Troubleshooting for the way to clear the error. 6.6 Preparing Samples All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory. WARNING Do not contact patients' sample blood directly. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. Prepare samples per the procedure recommended by the tube manufacturer. The samples collected in capillary tubes must be analyzed with the tubes not capped under open vial mode.
Operating Your Analyzer 6-13 NOTE Be sure to use clean K2EDTA anticoagulant collection tubes, fused silica glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary tubes. Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc. 6.6.1 Whole blood samples 1. Use clean K2EDTA (1.5 - 2.2mg/mL) anticoagulant collection tubes to collect venous blood samples. 2. Mix the sample according to your laboratory's protocol. CAUTION To attain accurate analysis results, make sure the sample volume is no less than 1.0ml in the autoloading mode, and no less than 0.5ml in the open-vial mode (predilute not included). Before running the refrigerated (2℃ - 8℃) samples, warm them at room temperature for at least 30 minutes. Be sure to mix well any sample that has been prepared for a while before running it. 6.6.2 Prediluted samples 1. Tap the “Mode” button at the “Count” screen.
Operating Your Analyzer 6-14 2. Select “OV-PD”, and then click “OK” to switch to the predilute mode. 3. Tap the utility button “Diluent”. NOTE The number in the “Cancel” button shows the number of diluent dispensation after your last tapping of the “Diluent” button. 4. Present a clean uncapped centrifugal tube to the sample probe and make sure the probe go deep into the bottom of the tube, as the figure shows, to avoid spills, hangings
Operating Your Analyzer 6-15 and bubbles. 5 Press the Aspirate key to start dispensing the diluent. 6 Remove the centrifugal tube when the buzzer sounds. 7 Add 40μL of capillary blood to the diluent, close the tube cap and shake the tube to mix the sample. 8 After the prediluted sample is prepared, tap the “Cancel” button to quit dispensing the diluent. 9. If more portions of diluent are needed, repeat the procedure 3-5. NOTE You can also aspirate 140μL of diluent by pipette into the tube. Be sure to keep dust from the prepared diluent. After mixing the capillary sample with the diluent, be sure to wait 3 minutes before running the sample. Be sure to run the prediluted samples within 30 minutes after the mixing.
Operating Your Analyzer 6-16 Be sure to mix any sample that has been prepared for a while before running it. Be sure to evaluate predilute stability based on your laboratory's sample population and sample collection techniques or methods.
Operating Your Analyzer 6-17 6.7 Sample Analysis in the OV Mode 6.7.1 Selecting work mode At the "Count” screen, tap the "Mode" button, the dialog box below will pop up. Abbreviations used for modes: Abbreviation Indication OV Open-Vial AL Autoloading WB Whole-Blood PD Predilute C CBC D DIFF N NRBC R RET
Operating Your Analyzer 6-18 Running without following the worklist 1. At the "Mode" screen, tap "OV-WB" radio button to select open vial whole blood mode, or tap "OV-PD" radio button to select open vial predilute mode. 2. Tap any radio button in the analysis mode area at the bottom left of the screen to set the analysis mode. 3. If necessary, edit the sample ID of the next sample in the "Sample ID" box; the default ID will be used if you did not edit the sample ID. For details of setup related to the entry of sample ID, see Auxiliary setup > Sample ID setup in 5.3.1 General Setup ("Setup" > "General Setup"). 4. Tap "OK" button to save the data entered and return to the "Count” screen. Running following the worklist 1. At the "Mode" screen, tap "OV-WB" radio button to select open vial whole blood mode, or tap "OV-PD" radio button to select open vial predilute mode. 2. Check the "Run as per Worklist" check box, the analyzer will search for the matched sample IDs automatically under OV mode. If there are matching results, the analysis will be performed per the mode in the worklist. If there are no matching results, and open vial analysis is performed for the first time, the analysis will be performed per the presentation mode you selected and the default analysis mode "C+D". If there are no matching results, and open vial analysis is not performed for the first time, the analysis will be performed per the mode of the previous sample analyzed. 3. Tap "OK" button to save the data entered and return to the "Count” screen.
Operating Your Analyzer 6-19 NOTE When analysis mode is shifted from "Whole Blood" to "Predilute" or sampling mode changes, the analyzer will switch mode automatically and pop-up message will be displayed. 25 characters are allowed for sample ID maximally (including prefix); the ID must end with a number, and must not be consisted of "0" only. The default sample ID under open vial mode is determined by the setting of "Entry of next sample ID", see 5.3.1 General Setup ("Setup" > "General Setup") for the setup method. When the analyzer is not connected with the PC, the "Run as per worklist" button is gray, the function is deactivated. 6.7.2 Entering Worklist Information You can enter the work list information for the next sample at the DMU before running it. NOTE If the analyzer is shut down abnormally, you will lose the worklist information of the samples that have not been saved yet. If you want to enter the worklist information after the analysis, see Chapter 7 Reviewing Sample Results for details. Click "Worklist" from the DMU software to enter the "Worklist" screen.
Operating Your Analyzer 6-20 Click "New", a new entry will be built in the list area, and then you can enter the sample information (mandatory) and patient information (if needed) in the data entry area below. Enter sample ID Enter the sample ID in the “Sample ID” field. If the “Entry of Next Sample ID” is set to be “Auto Increase” (see Auxiliary setup > Sample ID setup in 5.3.1 General Setup ("Setup" > "General Setup")), the default "Sample ID" will increase by 1 when you add a new entry again. NOTE 25 characters are allowed for sample ID maximally (including prefix); the ID must end with a number, and must not be consisted of "0" only. Select mode Click the pull-down lists to select the presentation mode, sample mode and test panel. Enter patient ID Enter the patient ID in the "Patient ID" field. Enter patient name Enter the patient name into the "First Name" and “Last Name” Fields. Enter/Select patient gender Enter the gender of the patient in the "Gender" field or select it from the "Gender" pull-down list. Enter the patient's date of birth Enter the patient's date of birth into the "Date of birth" field, or click the pull-down arrow to select the date of birth from the date control. Enter patient age The analyzer provides four ways for you to enter the patient's age: in years, in months, in days and in hours. The first way is designed for adults or pediatric patients older than one year; the second for infant patients who are one month to one year old; the third for neonatal patients no older than one month and the fourth the neonatal no older than 24 hours. You can choose only one of the four ways to enter the patient age. Select from “Year(s)”, “Month(s)”, “Day(s)” or “Hour(s)” in the “Age” pull-down list, and then define the corresponding value before the pull-down list.
Operating Your Analyzer 6-21 NOTE If the patient's date of birth is entered, his/her age will be calculated automatically, and the age field will gray out and cannot be edited Select ref. group Select the reference group for the sample from the "Ref. Group" pull-down list. Different reference groups have different reference ranges based on which the analyzer gives high and low flags of analysis results. See 5.3.6 Ref. Ranges (Administrator) ("Setup" > "Reference Ranges") for details. NOTE If the patient's gender and age are entered, then the matching ref. group will be automatically displayed. Enter/Select department name Enter the name of the department into the “Department” field or select it from the “Department” pull-down list (if defined in data dictionary. See 5.3.4 for details). Enter/Select ward name Enter the name of the ward into the “Ward” field or select it from the “Ward” pull-down list (if defined in data dictionary. See 5.3.4 for details). Enter/Select Bed No. Enter the bed No. of the patient into the “Bed No.” field or select it from the “Bed No.” pull-down list (if defined in data dictionary. See 5.3.4 for details). Enter/Select sample type Enter the sample type into the “Sample Type” field or select it from the “Sample Type” pull-down list (if defined in data dictionary. See 5.3.4 for details). Enter draw time Enter the date and time when the sample is drawn into the “Draw Time” field or click the pull-down arrow and select from the date control. Enter order time Enter the time when the analysis order is put into the "Order Time" field or click the pull-down
Operating Your Analyzer 6-22 arrow and select the time from the date control. NOTE The order time shall not be earlier than the draw time. The draw time and order time shall not be later than the current system time. Enter deliverer name Enter the name of the person who deliver the test order to the laboratory into the "Delivered by" field or select it from the "Delivered by" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). Enter clinical diagnosis Enter the clinical diagnosis result into the "Diagnosis" field or select it from the "Diagnosis" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). If there is too much clinical diagnosis information to be entered, click the ">" button after the "Diagnosis" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box. Enter comments Enter comments into the "Comments" box or select it from the "Comments" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). If there is too much information to be entered, click the ">" button after the "Comments" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box. Save After you finish editing the worklist, click "Save" button to save the information. 6.7.3 Sample Analysis Procedure All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Operating Your Analyzer 6-23 WARNING The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. Sample agglutination may result in inaccurate analysis result. Check if the sample is agglutinated before analysis, if yes, handle per the operation requirements of your laboratory. NOTE After starting analysis, do not open the front cover of the analyzer. The sample probe should be kept away from the tube bottom when the probe is aspirating sample. Otherwise, the aspirated volume may be imprecise. The probe tip should not contact the sample tube. Otherwise, the blood may spill. Proper reference range shall be selected at the "Setup" screen of the PC before analysis. Otherwise, the results may be flagged erroneously. If you start sample analysis immediately after selecting work mode, then the default reference range is "General”. After the analysis finishes, the analyzer will flag results per the reference range "General". Running whole blood samples 1. Make sure that the presentation mode displayed in the "Next sample" information area of the count screen is shows OV-WB. 2. Shake the tube of whole blood sample as instructed by the picture below to mix the sample thoroughly.
Operating Your Analyzer 6-24 3. When it is ready to run a sample (i.e. the analyzer indicator is green), present the whole blood sample to the sample probe. 4. Press the aspirate key to start sample analysis. 5. The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer automatically analyzes the sample, the analyzer indicator is flickering in green and information in the "Next Sample" information area refreshes automatically. 6. When the analysis finishes, the analyzer indicator return to green. 7. Run the rest samples as instructed above. Running prediluted samples 1. Make sure the presentation mode displayed in "Next sample" information area of the count screen shows OV-PD. 2. Shake the capped tube of the prediluted sample to mix it thoroughly. 3. When it is ready to run a sample (i.e. the analyzer indicator is green), open the cap of the sample tube carefully and present the sample to the sample probe. 4. Press the aspirate key, a dialog box will pop up.
Operating Your Analyzer 6-25 5. Press the aspirate key to close the dialog box and start analysis. NOTE You can choose to disable the dialog box before predilute analysis. See 5.2.1Date Setup for the setup method. 6. The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer automatically analyzes the sample, the analyzer indicator is flickering in green and information in the "Next Sample" information area refreshes automatically. 7. When the analysis finishes, the analyzer indicator return to green. 8. Run the rest samples as instructed above. NOTE During the analysis, you can perform any operation (including new, edit and cancel, etc.) to other "Ready" or "Error" samples in the work list. When the analyzer is running, all the functions related to the fluidics sequence can not be used. If you were not at the review screen, then when you switch to the review screen, the latest record information together with its results and graph will be displayed. During the analysis process, if errors like clog or bubble occur, the analyzer will automatically display the results of related parameters as invalid, and alarm information will show on the error information area. See Chapter 11 Troubleshooting for the way to remove errors. 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 for solutions. 6.7.4 Special Functions Automatic saving of analysis results This analyzer automatically saves sample results. When the maximum number of results that can be saved has been reached, the newest result will overwrite the oldest.
Operating Your Analyzer 6-26 Parameter flags If the parameter is followed by an "H" or "L", it means the analysis result has exceeded the upper or lower limit of the reference range, but still within the display range. If the parameter is follow by the suspect flag (the default suspect flag is "R"), it means the analysis result is suspicious. If you see **** as the result, it means the result is invalid or out of the display range. NOTE The results of background check will not be flagged for abnormal parameters, abnormal blood cell differential or morphology. You can change the default flags on the PC, see 5.3.1 General Setup ("Setup" > "General Setup") for reference. Flags of Abnormal Blood Cell Differential or Morphology CAUTION Abnormal cells may not necessarily trigger the flags during the analysis process, it is recommended that reexamination is conducted per the operation instruction of your laboratory. Flag Message Indication Criteria WBC Scattergram Abn. Abnormal distribution of WBC scattergram The distribution of DIFF scattergram and/or BASO scattergram is abnormal NRBC Scattergram Abn. Abnormal distribution of NRBC scattergram NRBC scattergram is abnormal Neutropenia Neu# low Neu# < 1.00×10^9/L Neutrophilia Neu# high Neu# > 11.00×10^9/L Lymphopenia Lym# low Lym# < 0.80×10^9/L Lymphocytosis Lym# high Lym# > 4.00×10^9/L Monocytosis Mon# high Mon# > 1.50×10^9/L Eosinophilia Eos# high Eos# > 0.70×10^9/L Basophilia Bas# high Bas# > 0.20×10^9/L Leukopenia WBC low WBC < 2.50×10^9/L Leukocytosis WBC high WBC > 18.00×10^9/L NRBC present NRBC detected in the NRBC channel NRBC% > 1% and NRBC# > 0.01 Blasts? Possible presence of blasts Presence of excessive dots in blast sensitive region of the scattergram
Operating Your Analyzer 6-27 Abn Lympho/ Blasts？ Possible presence of abnormal lymphocytes or blasts Presence of excessive dots in abnormal lymphocyte/blast sensitive region of the scattergram Immature Gran? Possible presence of immature granulocytes Presence of excessive dots in immature granulocyte sensitive region of the scattergram Left Shift? Possibility of left shift Presence of excessive dots in left shift sensitive region of the scattergram Atypical Lymph? Possible presence of atypical lymphocytes Presence of excessive dots in atypical lymphocyte sensitive region of the scattergram NRBC? Possible presence of NRBC Presence of excessive dots in NRBC sensitive region of the scattergram RBC Lyse resistance? Possibility of RBC lyse resistance Presence of abnormally distributed dots in WBC sensitive region of the WBC scattergram RBC Histogram Abn. Abnormal distribution of RBC histogram The distribution of RBC histogram is abnormal RET Scattergram Abn. Abnormal distribution of RET scattergram The distribution of RET scattergram is abnormal Dimorphic Population Two or more wave crests in the RBC histogram Two or more wave crests in the RBC histogram Reticulocytosis RET high RET% > 5% or RET#>0.20×10^12/L Anisocytosis Anisocytosis RDW-CV> 22 or RDW-SD > 64fL Microcytosis MCV low MCV < 70fL Macrocytosis MCV high MCV > 110fL Hypochromia Hypochromia MCHC<290 Anemia Anemia HGB < 90g/L Erythrocytosis RBC high RBC > 6.5×10^12/L RBC Agglutination？ RBC results possibly inaccurate Calculate and compare special parameters Turbudity/HGB Interference? Hemoglobin abnormal or there is HGB interference Calculate and compare special parameters Iron Deficiency? Possibility of iron deficiency Calculate and compare special parameters Fragments? Possible presence of RBC fragments Presence of abnormally distributed dots in sensitive region of the RET channel PLT Scattergram Abn. Abnormal distribution of PLT scattergram The distribution of PLT scattergram is abnormal PLT Histogram Abn. Abnormal distribution of PLT histogram The distribution of PLT histogram is abnormal Thrombopenia PLT low PLT<60×10^9/L Thrombocytosis PLT high PLT>600×10^9/L
Operating Your Analyzer 6-28 PLT Clump? Possibility of PLT clump Calculate and compare special parameters Pancytopenia WBC, RBC and PLT low WBC < 4.0 and RBC < 3.5 and PLT < 100 Lipid Particles? Possible presence of lipid particles Presence of excessive dots in lipid particle sensitive region of the scattergram Infected RBC? Possible presence of infected RBC Presence of excessive dots in infected RBC sensitive region of the scattergram
Operating Your Analyzer 6-29 6.8 Sample Analysis in the Autoloading Mode 6.8.1 Enter Worklist Information You can enter the work list information for the next sample at the DMU before running it. NOTE If the analyzer is shut down abnormally, you will lose the worklist information of the samples that have not been saved yet. If you want to enter the worklist information after the analysis, see Chapter 7 Reviewing Sample Results for details. Click "Worklist" from the DMU software to enter the "Worklist" screen. Click "New", a new entry will be built in the list area, and then you can enter the sample information (mandatory) and patient information (if needed) in the data entry area below. Enter sample ID Enter the sample ID in the “Sample ID” box. If the “Entry of Next Sample ID” is set to be “Auto Increase” (see Auxiliary setup > Sample ID setup in 5.3.1 General Setup ("Setup" > "General Setup")),, the default "Sample ID" will increase by 1 when you add a new entry again.