Using the QC Programs 8-70 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The operation of deletion will be recorded in the log. New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1. Move the green line to the first QC point of the new vial. 2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial. 3. After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2. To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button Data Compare You can compare the QC graphs of the same parameter obtained by running different batches
Using the QC Programs 8-71 of control. 1. Click the “Data Compare” button to go to the data compare screen. 2. Select the parameter you want to compare from the “Parameter” pull-down list. 3. Specify 2-3 file numbers you want to compare from the “File No.” pull-down lists, and the corresponding information and graph will be displayed. 4. Use the arrow buttons at the bottom to move to the first/previous/next/last QC point. 5. Click “Print” to print the screen if needed. 6. Click “Close” to exit. NOTE The color of lines connecting the QC points in a QC file differs according to the level of the control. The colors are defined on bottom left of the “Data Compare” screen (L=low level; M=Normal Level; H=high level). Adjust the sequence of parameters (administrator) You can adjust the sequence of the parameters displayed in the QC graph at the administrator level. Do as follows to adjust the sequence of parameters displayed in the QC graph screen.
Using the QC Programs 8-72 1. Click the "Sequence" button, and a dialog box will pop up. 2. Select the parameter that you want to adjust. 3. Use the order adjusting buttons to move it upwards/downwards/to top/to bottom. 4. Click the "OK" button to save the change and close the dialog box. Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1. Click the "Calculate Preset Values" button, and then two black lines are displayed to locate the range for calculating the preset values. 2. Click and drag the two lines respectively to locate them at the beginning and the end of the range for calculating the preset values. 3. The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range. 4. If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels
Using the QC Programs 8-73 (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results. NOTE The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty. Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all. Enters the reasons for the outliers (administrator) You can enter the reasons for an outlier at the administrator level. 1. After moving the green line to the desired QC point, you can click the "Outliers" button to display the QC results, targets and limits of all the parameters (the QC results exceed the limit will be displayed in red) and enter the reasons for the outliers. 2. You can select reasons from the given ones or select the option "Other" and then enter the reasons into the text box manually (up to 200 characters). 3. Click “OK” to save and exit.
Using the QC Programs 8-74 NOTE If you enter the outlier reason for the group of QC points whose results are actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in red. The data will return to be black if you cancel the outlier reason and then save the changes. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters. NOTE The green line and the corresponding values of the QC points will not be printed. Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of the QC graph. Click the “Close” button to exit. X mean QC table review 1. Click "QC", and then select "X Mean QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the "Table" tab to enter the X mean QC table screen.
Using the QC Programs 8-75 3. Select the QC file No. you want to review, and then the screen will display the corresponding information and the QC table. 4. You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results. Introduction to the "Table" screen 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left 1 2 3 5 4
Using the QC Programs 8-76 to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently. NOTE For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow. Delete (administrator) You can delete the QC table data at the administrator level. 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The operation of deletion will be recorded in the log.
Using the QC Programs 8-77 Print 1. Click the "Print" button, and a dialog box will pop up. 2. Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed. 3. Click “OK” to start printing and close the dialog box. Print preview 1. Click the "Print Preview" button, and a dialog box will pop up. 2. Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview. 3. Click “OK” to go to the print preview window. 4. Click the “Close” button to close the window.
Using the QC Programs 8-78 Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1. Click the "Communication" button, and a dialog box will pop up. 2. Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you want to transmit. 3. Click the "Start" button to start transmitting data. NOTE If auto-communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start. The QC data saved in the process of transmission will not be transmitted. Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1. Click the "Data Export" button, a dialog box will pop up. 2. Select the export directory in the pop up box. 3. Edit the file name of the data to be exported if needed. 4. Select the format of the data to be exported. (default format: “.csv”) 5. Click the "Save" button to start the export.
Using the QC Programs 8-79 NOTE You can modify the exported data if needed but cannot check the data at the "History" screen. You can click the "Cancel" button to cancel exporting when it is in process. Edit and save result (administrator) You can select and edit results at the administrator level. After editing, click the "Save" button to save the change. A flag "E" will be marked after the results that have been edited. Restore result (administrator) You can restore the initial measurement results after editing them at the administrator level. 1. Click the "Restore" button. 2. Select to restore “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to restore the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box.
Using the QC Programs 8-80 8.5 X Mean R QC Program 8.5.1 QC Setup (Administrator) 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. NOTE If the "In Use" check box of a QC file is ticked, the QC information will be transmitted to the SPU when the connection is built up, and the matching QC results will be saved in this file. Before analyzing a new batch of controls with the X mean R program, you should set up a QC file for each lot of controls. 1. Click "QC”, and then select "X mean R QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Setup” button to go to the X mean R QC setup screen.
Using the QC Programs 8-81 3. Select an empty QC file (ranging from 1 to 60) from the “File Info.” table. There are 3 columns which cannot be edited in the “File Info.” table: File No. (Sequence number of the QC file) Editor (the information of the user who edited the file, in the format of “User ID(User Name)”) Existing Data/Capacity (number of existing records for the file/the maximum records that can be saved in the file) To set up the QC file, you shall enter the required “File Info.” as follows: 1. You can enter the lot No. of the controls by one of the following ways: Manual entry Using external barcode scanner NOTE The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but Chinese characters are not allowed. 2. Select the control level from the pull-down list (L for low level, N for normal level and H for high level). 3. Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control.
Using the QC Programs 8-82 NOTE The format of the expiration date is determined by the configuration of the PC. The expiration date shall not be earlier than the current system date 4. Select the source of control from the pull-down list. 5. Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations). 6. Tick the “In Use” box if needed. 7. Click the “Save” button to save the QC information. NOTE The "In Use" check box of a QC file is ticked automatically when you save the setup for the file. For QC files having the same lot no., QC test panel and QC sample ID, only the last saved one will be “In Use”. 8.5.2 Running Controls After editing the QC information, you can start QC analysis by one of the following ways in the selected QC mode. OV-WB AL-WB 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 The sample probe is shape and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
Using the QC Programs 8-83 The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes. Keep you clothes, hairs and hands away from the moving parts to avoid injury. 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. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. Sample aggregation may result in inaccurate analysis result. Check if the control is agglutinated before analysis, if yes, handle per the operation requirements of your laboratory. NOTE Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc. If the sample mode is switched from the "Predilute" to "Whole Blood", the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen. OV-WB 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
Using the QC Programs 8-84 imprecise. The probe tip should not contact the sample tube. Otherwise, the blood may spill. 1. Click the MENU button on the screen, and then select "QC" on the pop-up menu. 2. Click "Setup" button, the QC setup dialog box will pop up. 3. Select “QC Type” as "X mean R QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen.
Using the QC Programs 8-85 NOTE Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired. The expiration date of expired controls is displayed in red. 4. Prepare the control as instructed by instructions for use of the controls. 5. Run QC analysis: 1) Make sure the analysis mode is "OV-WB" and the indicator of the analyzer is green. 2) Wave the whole blood sample as instructed by below picture to mix the sample thoroughly. 3) Click "Start Count" button. 4) Present the whole blood sample to the sample probe. 5) Press the aspirate key to start QC run. 6) When you hear the beep, remove the control. 6. When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically. NOTE Up to 372 QC results can be saved in each QC file. 7. Do the above procedures to continue running QC analysis if necessary.
Using the QC Programs 8-86 AL-WB 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 The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it. The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes. Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the autoloader or getting the collection tubes from the autoloader, be sure not to break the tubes. The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader. Keep you clothes, hairs and hands away from the moving parts to avoid injury. 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. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
Using the QC Programs 8-87 NOTE After starting analysis, do not open the front cover of the analyzer. If abnormal power interruption occurs after analysis is started, you should remove the racks manually and open the front cover to see if there are dropped tubes to be removed. Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc. 1. Click the MENU button on the screen, and then select "QC" on the pop-up menu. 2. Click "Setup" button, the QC setup dialog box will pop up.
Using the QC Programs 8-88 3. Select “QC Type” as "X mean R QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen. NOTE Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired. The expiration date of expired controls is displayed in red. 4. Prepare the control as instructed by instructions for use of the controls, and paste barcode labels to the control vials (for details about pasting barcodes, see 6.8.4 Barcode Labels). 5. Run QC analysis: 1) Make sure the QC mode is "AL-WB" and the analysis status icon and analyzer indicator is green. 2) Make sure the barcode labels are well pasted to the containers of the controls. 3) Click "Start Count" button. 4) Present the prepared control into the rack. 5) Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer. 6) Press the [Count] key or click the "Count" button on the dialog box to start running. 7) When the running completes, you can remove the racks from the left of the autoloader. 6. When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically.
Using the QC Programs 8-89 NOTE Up to 372 QC results can be saved in each QC file. 7. Do the above procedures to continue running QC analysis if necessary. 8.5.3 Reviewing X mean R QC results After QC analysis, you can review the QC results in the following two ways: QC Graph QC Table X mean R QC graph review 1. Click "QC", and then select "X Mean R QC" from the "QC Program" pull-down list to enter the X mean R QC graph screen. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Select the QC file No. you want to review, and then the screen will display the corresponding information and the graph. 3. You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the
Using the QC Programs 8-90 QC results. Introduction to the "Graph" screen 1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The operator who run the QC analysis and obtained the QC points on the green line. 4- The QC result corresponding to the QC point on the green line. 5- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 6- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 7- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 8- The sequence number of the QC points on the green line and the total groups of QC points saved currently. NOTE The outliers are excluded from the calculation of Mean, SD and CV%. For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow. Delete (administrator) You can delete the QC graph data at the administrator level. 1 2 3 4 5 6 7 8
Using the QC Programs 8-91 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The operation of deletion will be recorded in the log. New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1. Move the green line to the first QC point of the new vial. 2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial. 3. After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2. To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button Data Compare You can compare the QC graphs of the same parameter obtained by running different batches
Using the QC Programs 8-92 of control. 1. Click the “Data Compare” button to go to the data compare screen. 2. Select the parameter you want to compare from the “Para.” pull-down list. 3. Specify 2-3 file numbers you want to compare from the “File No.” pull-down lists, and the corresponding information and graph will be displayed. 4. Use the arrow buttons at the bottom to move to the first/previous/next/last QC point. 5. Click “Print” to print the screen if needed. 6. Click “Close” to exit. NOTE The color of lines connecting the QC points in a QC file differs according to the level of the control. The colors are defined on bottom left of the “Data Compare” screen (L=low level; M=Normal Level; H=high level). Adjust the sequence of parameters (administrator) You can adjust the sequence of the parameters displayed in the QC graph at the administrator level. Do as follows to adjust the sequence of parameters displayed in the QC graph screen.
Using the QC Programs 8-93 1. Click the "Sequence" button, and a dialog box will pop up. 2. Select the parameter that you want to adjust. 3. Use the order adjusting buttons to move it upwards/downwards/to top/to bottom. 4. Click the "OK" button to save the change and close the dialog box. Enters the reasons for the outliers (administrator) You can enter the reasons for an outlier at the administrator level. 1. After moving the green line to the desired QC point, you can click the "Outliers" button to display the QC results, targets and limits of all the parameters (the QC results exceed the limit will be displayed in red) and enter the reasons for the outliers.
Using the QC Programs 8-94 2. You can select reasons from the given ones or select the option "Other" and then enter the reasons into the text box manually (up to 200 characters). 3. Click “OK” to save and exit. NOTE If you enter the outlier reason for the group of QC points whose results are actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in red. The data will return to be black if you cancel the outlier reason and then save the changes. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters. NOTE The green line and the corresponding values of the QC points will not be printed. Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of the QC graph. Click the “Close” button to exit.
Using the QC Programs 8-95 X mean R QC table review 1. Click "QC", and then select "X Mean R QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the "Table" tab to enter the X mean R QC table screen. 3. Select the QC file No. you want to review, and then the screen will display the corresponding information and the QC table. 4. You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results.
Using the QC Programs 8-96 Introduction to the "Table" screen 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently. NOTE For the QC files with saved QC results, if any change is made to the target or the limits, the changed data will be highlighted in yellow. Delete (administrator) You can delete the QC table data at the administrator level. 1. Click the "Delete" button, and a dialog box will pop up. 1 2 3 5 4
Using the QC Programs 8-97 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The operation of deletion will be recorded in the log. Print 1. Click the "Print" button, and a dialog box will pop up. 2. Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
Using the QC Programs 8-98 3. Click “OK” to start printing and close the dialog box. Print preview 1. Click the "Preview" button, and a dialog box will pop up. 2. Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview. 3. Click “OK” to go to the print preview window. 4. Click the “Close” button to close the window. Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1. Click the "Communication" button, and a dialog box will pop up. 2. Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you
Using the QC Programs 8-99 want to transmit. 3. Click the "Start" button to start transmitting data. NOTE If auto-communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start. The QC data saved in the process of transmission will not be transmitted. Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1. Click the "Data Export" button, a dialog box will pop up. 2. Select the export directory in the pop up box. 3. Edit the file name of the data to be exported if needed. 4. Select the format of the data to be exported. (default format: “.csv”) 5. Click the "Save" button to start the export. NOTE You can modify the exported data if needed but cannot check the data at the "History" screen. You can click the "Cancel" button to cancel exporting when it is in process. Edit and save result (administrator) You can select and edit results at the administrator level. After editing, click the "Save" button to save the change. A flag "E" will be marked after the results that have been edited. Restore result (administrator) You can restore the initial measurement results after editing them at the administrator level. 1. Click the "Restore" button.
Using the QC Programs 8-100 2. Select to restore “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to restore the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box.
Using the QC Programs 8-101 8.6 X-M QC Program 8.6.1 X-M QC principle The X-M analysis is a weighted moving average analysis that uses values obtained from patient samples. It uses the parameters of CBC, DIFF, NRBC and RET to indicate the hematology instrument performance. Effective use of X-M requires randomization of samples and a normal cross section of patients to prevent skewing of indices. The analyzer implement X-M QC on all the 33 parameters (expect the RUO parameters), each group of samples for X-M analysis consists of 2-500 sample results obtained from normal analysis of both WB and PD modes. The analyzer can save up to 1000 X-M QC results. When the saved QC results have reached the maximum number, the newest result will overwrite the oldest. 8.6.2 QC Setup (Administrator) 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. 1. Click "QC”, and then select "X-M QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Setup” button to go to the X-M QC setup screen.
Using the QC Programs 8-102 At the X-M QC setting screen, you can configure the “X-M QC” information, “Target/Limit” and “Sample Validity Setup”. QC information setup 1. In the "Samples/Batch" text box of the X-M QC setup screen, you can enter the amount of samples (shall be within the range from 2 (default) to 500) to be included in calculating for an X-M QC point. 2. Select “On” to enable the X-M QC, and then all samples compliant with the sample validity setup will be included in the X-M QC calculation; or Select “Close” to disable the X-M QC. Target/Limit setup Before the X-M QC analysis, you shall set up the target and limit for each parameter at the X-M QC setup screen using one of the following ways: Manual entry Reading the saved preset values. NOTE The units for the targets and limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details.
Using the QC Programs 8-103 Manual Entry 1. In the X-M QC setup screen, specify the targets and limits in the “Target/Limit” table by entering manually. NOTE Do not leave any of the targets and limits for the QC parameters blank. When first use, the default setting will provide the initial values for the targets and limits of all QC parameters. 2. Click the "Save" button to save the changes. Reading the Saved Preset Values NOTE If there are saved preset values (Target and Limits) for the X-M QC, you can read the preset values into the X-M QC setup screen. For details of calculating and saving the preset values, see Section 8.6.4 Reviewing X-M QC results. 1. In the X-M QC setup screen, click the "Get Preset Values" button to read the saved preset target and limits into the X-M QC setup screen. NOTE Do not leave any of the targets and limits for the QC parameters blank. If some of the parameters do not have preset values, you shall enter them manually. 2. Click the "Save" button to save the changes. Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1. In the X-M QC setup screen, click the “Set Limits” button, and then the following dialog box will pop up.
Using the QC Programs 8-104 2. Click “By SD” to display the limits in the form of absolute value; or Click “By CV” to display the limits in the form of percentage. 3. If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard deviation to be the preset limits; If “By CV” is selected, click the “2CV” or “3CV” to select either double or triple coefficient of variation to be the preset limits. 4. Click the “OK” button to save and close the dialog box. Setting sample validity In X-M QC, sample results conforming to any of the following conditions will be considered as invalid and cannot be used in the QC calculation. Sample results exceeding the linearity range; Background results; Sample results not conforming to the "Sample Validity Setup"; QC data for L-J, X mean and X mean R QC; Calibration data; Results generated while there are errors which could affect the accuracy of the results (insufficient aspiration volume or clogging for example). "Sample Validity Setup" is to set up the ranges of valid X-M QC results. Only when the results of all these parameters are within the specified ranges, the sample results can be used for X-M QC calculation. Do as follows to set the sample validity: 1. In the X-M QC setup screen, set the upper and lower limits of the parameters in the sample validity setup area. 2. Click "Save" to save the setup.
Using the QC Programs 8-105 NOTE In the sample validity setup, the upper limit shall be greater than the lower limit. Otherwise, there will be prompted message asking you to revise. The valid ranges of the parameters are their display ranges. All the entries shall be numbers with only one decimal point. The length of the number entered cannot be longer than the length of the text box. Once the validity range is changed, the previous results will not be used in the QC calculation as valid results. For example, if 20 valid samples are needed for the X-M QC calculation, when you change the validity range after 10 groups of valid sample results have been acquired, these 10 groups of results will be discarded, and only valid sample results generated afterwards will be used in the QC calculation. The units for the lower and upper limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details. 8.6.3 Running Controls 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. After editing X-M setup, the system will start X-M run automatically. After every 2-500 results (determined by the setting) are obtained, the system will perform the X-M calculation once automatically. You can review the result in X-M QC graph or X-M QC table. 8.6.4 Reviewing X-M QC results X-M QC graph review 1. Click "QC”, and then "X-M QC" from the "QC Program" pull-down list to enter the X-M QC graph screen.
Using the QC Programs 8-106 NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results. Introduction to the "Graph" screen 1 2 3 4 6 7 5
Using the QC Programs 8-107 1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The QC result corresponding to the QC point on the green line. 4- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 5- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 6- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 7- The sequence number of the QC points on the green line and the total groups of QC points saved currently. NOTE The outliers are excluded from the calculation of Mean, SD and CV%. Delete (administrator) You can delete the QC graph data at the administrator level. 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box.
Using the QC Programs 8-108 NOTE The delete operation will be recorded in the log. Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1. Click the "Calculate Preset Values" button, and then two black lines are displayed to locate the range for calculating the preset values. 2. Click and drag the two lines respectively to locate them at the beginning and the end of the range for calculating the preset values. 3. The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range. 4. If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results. NOTE The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty. Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters. NOTE The green line and the corresponding values of the QC points will not be printed. Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of QC graph. Click the “Close” button to exit.
Using the QC Programs 8-109 X-M QC table review 1. Click "QC”, and then select "X-M QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Table” button to go to the X-M QC table review screen. 3. You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results.
Using the QC Programs 8-110 Introduction to the "Table" screen 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently. Delete (administrator) You can delete the QC table data at the administrator level. 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. 1 2 3 5 4
Using the QC Programs 8-111 NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The delete operation will be recorded in the log. Print 1. Click the "Print" button, and a dialog box will pop up. 2. Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed. 3. Click “OK” to start printing and close the dialog box. Print preview 1. Click the "Preview" button, and a dialog box will pop up.
Using the QC Programs 8-112 2. Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview. 3. Click “OK” to go to the print preview window. 4. Click the “Close” button to close the window. Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1. Click the "Communication" button, and a dialog box will pop up. 2. Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you want to transmit. 3. Click the "Start" button to start transmitting data.
Using the QC Programs 8-113 NOTE If auto communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start. The QC data saved in the process of transmission will not be transmitted. Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1. Click the "Data Export" button, a dialog box will pop up. 2. Select the export directory in the pop up box. 3. Edit the file name of the data to be exported if needed. 4. Select the format of the data to be exported. (default format: “.csv”) 5. Click the "Save" button to start the export. NOTE You can modify the exported data if needed but cannot check the data at the "History" screen. You can click the "Cancel" button to cancel exporting when it is in process.
9-1 9 Calibrating Your Analyzer 9.1 Introduction Calibration is a procedure to standardize the analyzer by determining its deviation under certain specified conditions. In order to get accurate sample analysis results, you should calibrate the analyzer per the procedure below when necessary. There are three calibration programs available on this analyzer: manual calibration, auto calibration using calibrators and auto calibration using fresh blood samples. All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be calibrated by the calibration programs. NOTE Calibration procedures can only be performed by users of the administrator-level. You should only use the Mindray-specified calibrators and reagents. Store and use the calibrations and reagents as instructed by instructions for use of the calibrators and reagents. The analyzer identifies a sample as a calibration sample only if the analysis is started from the "Calibration" screen. Calculation of reproducibility is included in the calibration procedure.
Calibrating Your Analyzer 9-2 9.2 When to Calibrate This analyzer is calibrated at the factory just before shipment. It is electronically stable and does not require frequent recalibration if you operate and maintain it as instructed by this manual. You only need to recalibrate this analyzer if: you are going to use this analyzer for the first time (usually done by a Mindray-authorized representative when installing the analyzer). an analytical component has been changed. you are going to re-use the analyzer after a long-term storage. the quality control results indicate there may be a problem. NOTE All of the measured parameters must be calibrated before readings of this analyzer can be used as valid analysis results.
Calibrating Your Analyzer 9-3 9.3 How to Calibrate 9.3.1 Preparation Do the following pre-calibration procedures before calibration. If problems are detected during these checks, do not attempt to calibrate the analyzer. If necessary, call Mindray Customer Service Department or your local distributor for assistance. 1. Check and make sure enough reagents have been prepared for the calibration. You need to start over the calibration if the reagents run out during the process. 2. Check the background (for calibration right after startup) or blank count results. If the analyzer alarms for abnormal background results, see 11 Troubleshooting for solutions. 3. Enter the "Count" screen and run a vial of blood sample consecutively for 10 times. Enter the "Table" review screen to check the reproducibility of the ten runs and make sure they meet the following requirements. Parameter Range Whole Blood Reproducibility CV% / absolute deviation (d) Predilute Reproducibility CV% / absolute deviation (d) WBC ≥ 4×109 /L ≤ 2.5% ≤ 4.0% RBC ≥3.5×1012/L ≤ 1.5% ≤ 2.0% HGB (110-180) g/L ≤ 1.0% Range**≤3.0 ≤ 2.0% MCV (80-100) fL ≤ 1.0% ≤ 3.0% PLT ≥100×109 /L ≤ 4.0% ≤ 8.0% NOTE If you are using fresh blood to perform the reproducibility test, make sure the volume of sample is adequate (suggested sample volume: no less than 3.0ml in open-vial mode; no less than 3.5ml in autoloading mode). If you are using fresh blood in AL-WB mode to perform the reproducibility test, be aware that the number of times that the tube is pierced may affect the accuracy of the test results.
Calibrating Your Analyzer 9-4 4. Run a vial of high level control consecutively for 3 times and then immediately run the diluent consecutively for 3 times. Calculate the carryover per the following equation. ％ － － 100 T high - levelsample result T low - levelsample result First low - levelsample result T low - levelsample result (%) hird hird hird Carryover The calculated carryovers shall meet the requirements in the following table. Parameter Carryover WBC ≤1.0％ RBC ≤1.0％ HGB ≤1.0％ HCT ≤1.0％ PLT ≤1.0％
Calibrating Your Analyzer 9-5 5. 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 The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it. 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 you clothes, hairs and hands away from the moving parts to avoid injury. Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. NOTE You should only use the Mindray-specified controls and reagents. Store and use the controls and reagents as instructed by instructions for use of the controls and reagents. Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.