Reviewing Sample Results 7-24 Graph-Related Flag 4. If needed, you can customize parameters included in Reported Parameters and RUO Parameters. To customize reported parameters Click “Customize”, and a dialog box will pop up. Check or uncheck the corresponding check boxes in the “Export?” column to specify whether to export the reported parameters. To customize RUO parameters Click “Customize RUO”, and a dialog box will pop up.
Reviewing Sample Results 7-25 Check or uncheck the corresponding check boxes in the “Export?” column to specify whether to export the reported parameters. 5. Click “Browse” to specify the directory to save the exported file. 6. Click “OK” to start the export and close the dialog box. Archive Sample Records (Administrator) Users at the administrator access level can archive the sample records of a specified period (including both the numeric and graphic data), in order to: Make a backup of data; Release space in the disk (need to select “Delete the records after archiving”). Since the DMU can store 100,000 sample records at most, and the oldest records will be overwritten after this limit is reached. Therefore, the manufacturer recommend that users archive data periodically on a reasonable basis to avoid data loss. You can archive sample records by doing as follows: 1. Click the “Archive” button, and the following dialog box will pop up.
Reviewing Sample Results 7-26 2. Specify the starting and ending date of the data to be archived. 3. Click “Browse” to specify the directory to save the archive. 4. If needed, select to “Delete the records after archiving”. If you check this box, all the archived records (including both the numeric and graphic data) will be deleted after the archiving is finished. 5. Click “Archive” to start archiving and close the dialog box. By archiving, the system will create a folder in the directory specified named by the date of archiving. The archived data can be reviewed in the “History” review screen (see 7.3.4 History Review). Adjust View Click the “View” button, and then the following menu will pop up.
Reviewing Sample Results 7-27 To switch to another tab Click “Table”, General", "WBC", "RBC", "Result Compare", "Microscopic Exam.", “RUO Para.”, “Intraday repeated results” or “Patient Info.” to switch to the corresponding tab. To restore default layout Click "Restore default layout" to restore the screen layout to default. To lock/unlock layout (administrator) The layout of the “Review” screen is locked by default. You can click "Unlock Layout" to unlock the layout. When the layout is unlocked, you can adjust the location of any module by dragging it to the destination, or close the modules you don’t need to simplify the view. When the layout is unlocked, the “Unlock Layout” menu option will automatically change into “Lock Layout”. Click “Lock Layout” to disable the layout change function.
Reviewing Sample Results 7-28 7.3.3 Right-Click Menu Functions Table Tab Select one or more records from the “Table” area, and then right click. The following menu will pop up. Print Click “Print” to print the selected record(s). Validate/Cancel (administrator) If the selected record(s) is/are not validated, click “Validate” to validate. If the selected record(s) is/are validated, click “Cancel” to cancel the validation. Delete (administrator) Click “Delete” to delete the selected record(s). Data Communication Click “Communication” to communicate the selected record(s). Error Alarm (operator)/Special Info. (administrator) The operator can check the error messages reported during the analysis of the selected sample by clicking “Error Alarm”; the administrator can check the error messages, as well as other special information in the process of sample analysis (like the HGB blank voltage, aperture voltage, etc.) by clicking “Special Info.”. Switch to report Click “Switch to report” switch to the report screen of the last selected record. Refresh Click “Refresh” to refresh the “Table” area.
Reviewing Sample Results 7-29 General Tab Right click in the “Parameter” area of the “General” tab, the following menu will pop up. Change the property Click “Property”, and a dialog box consisting of 2 tabs will pop up. “Parameter” tab:
Reviewing Sample Results 7-30 “Column” tab: Introduction There are two tables in the “Parameter”/”Column” tab: “Available Items” and “Selected Item”. The “Selected Item” table shows the parameters currently displayed in the “General” tab, while the “Available Items” table shows the parameters currently not in but can be added to the “General” tab. Insert item 1. Select the desired item from the “Available Items” table. 2. Click the “Insert” button. 3. The selected item will be inserted in front of the current item in the “Selected Item” table. 4. Click “OK” to save the change and close the dialog box. Add Item 1. Select the desired item from the “Available Items” table. 2. Click the “Add” button. 3. The selected item will be added on the bottom of the “Selected Item” table.
Reviewing Sample Results 7-31 4. Click “OK” to save the change and close the dialog box. Delete parameter 1. Select the desired item from the “Selected Item” table. 2. Click the “Delete” button. 3. The selected item will be deleted from the “Selected Item” table and displayed in the “Available Items” table. 4. Click “OK” to save the change and close the dialog box. Adjust item order 1. Select desired parameter from the “Selected Item” table. 2. Use the order adjusting buttons to adjust its position. 3. Click “OK” to save the change and close the dialog box. Adjust message order There are 3 types of flag messages displayed in the “General” tab: WBC Message, RBC message and PLT message. Right click on the desired message type, the following menu will pop up. Click “Message Order”, and the “Message Order” dialog box will pop up (see the WBC message order adjust dialog box below).
Reviewing Sample Results 7-32 Adjust message order 1. Select desired message from the table. 2. Use the order adjusting buttons to adjust its position. 3. Click “OK” to save the change and close the dialog box. Restore Defaults Click the “Restore Defaults” button, and then click “OK” to restore default order. 7.3.4 History Review If you have archived sample records use the “Archive” function (see 7.3.2 Button Functions > Archive Sample Records), you can review the archived history data in the “History” review screen. Click the “History” button in the “Review” screen to go to the “History” review screen.
Reviewing Sample Results 7-33 Load History Data You need to load history data before review. Do as follows: 1. Click the “Load History Data” button. 2. Browse to the desired folder of history data in the message box, and then click “OK”. NOTE You can only load one folder of history data at one time. If there are already data displayed in the “History” review screen before loading, only the newly loaded data can be displayed after the loading is finished. Unload History Data After reviewing the history data, you can click the “Unload History Data” button to unload the currently displayed data. Other buttons on the “History” review screen function in the same way as those in the “Review” screen.
Reviewing Sample Results 7-34 7.4 Report You can edit patient information, review and validate analysis results and print analysis report on the "Report" screen of the DMU. Click "Report" to enter the "Report" screen. 7.4.1 Introduction of the Screen The "Report" screen consists of the patient information area, result display area and result table area (from left to right in default layout). Some tabs are hidden in the default display. You can use the "View" button to display and switch to these tabs (see 7.4.2 Button Functions > Adjust View). Patient information area This area displays the patient information of the sample selected in the table. Switch to desired sample The first 2 fields are highlighted and used to switch to desired sample. If you specify a “Date of Analysis”, all the sample records will be displayed in the result table area, and the results of the first sample that day will be displayed in the result display area. If you specify a “Sample ID”, the corresponding records of that day will be highlighted in the result table area, and the results of this sample will be displayed in the result display area. If there is no matching sample on that day, a new item will be added in the result table area.
Reviewing Sample Results 7-35 Edit patient information You can edit the patient information of the samples, if the sample exists, the changes will be saved in real time; if the sample is newly added, the changes will be saved when you switch to another sample record. NOTE The patient information of the background results (sample ID: 0) cannot be edited. Result display area The result display area consists of the "Para.", "Microscopic Exam.", "RUO" and "Reference Results" tab screens, which display the parameter results, microscopic exam results, results of RUO parameters and raw results of all basic parameters respectively. The "Para." tab and “Microscopic Exam” tab are displayed by default; while the “RUO” tab can be displayed from the “View” button. Para. You can view the results of all report parameters, flags, and the 3 recent history records (if there is any). The history records refers to the previous analysis results which has the same Patient ID with the currently selected one, and they are displayed in “Third”, “Second” and “First” columns from the latest to earlier. Microscopic Exam If the sample type of the current sample is set in the data dictionary setup ("Setup" > “Data Dictionary”) and this sample type has predefined microscopic parameters ("Setup" > “Para. Setup” > “Microscopic Para. Setup”), you can edit the microscopic examination results of this sample in the "Microscopic Exam" tab.
Reviewing Sample Results 7-36 1. Modify the default “Time of Microscopic Exam.” If needed by entering from keyboard or select from the date text box. 2. If needed, enter the "Microscopic Description" in the text box. If there is too much information to be entered, click the ">" button after the "Microscopic Description" 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. 3. If needed, enter the "Comments" in the text box. 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. 4. Enter the results of the microscopic parameters in the corresponding text boxes if needed. RUO Para. You can review the results of RUO parameters and 4 scattergrams (DIFF, BASO, PLT-O, and NRBC) from this screen. Reference results You can view the raw values of all basic parameters in this tab. Result table area The result table area consists of the "Table", "Graph" and "Intraday repeated results" tab screens, which display the sample table of the day, graphs of the selected samples and information of the repeated results of the day. Table The "Table" displays a list of all analysis result records attained in a day. You can click the
Reviewing Sample Results 7-37 buttons at the bottom to show the desired type of records. Graph The "Graph" tab displays WBC, RBC, and PLT flag messages, 4 scattergrams (DIFF, BASO, RET, and NRBC) and 2 histograms (RBC and PLT).
Reviewing Sample Results 7-38 NOTE You can click on any scattergram or histogram for a zoom-in view of it, and then click elsewhere to exit. Intraday repeated results If a sample (the records with same sample IDs will be regarded as results of the same sample) is analyzed for several times on the same day, you can review these records from this screen. The upper part is the record table area showing the repeated sample records, among which the ticked one is to be reported; the lower part is the result display area showing all parameter results of the record selected in the list.
Reviewing Sample Results 7-39 7.4.2 Button Functions Edit result (Administrator) 1. Select the desired record from the “Table” or by specifying the “Date of Analysis” and “Sample ID”. 2. Click the "Edit Result" button, and all results that can be edited will be highlighted in pink in the “Parameter” tab of the result display area. 3. Select the desired parameter result and edit one by one.
Reviewing Sample Results 7-40 NOTE If the result of one parameter is modified, the result of other related parameter(s) will be changed accordingly and the high/low flags and suspect flags will also be renewed. Only the results of the measured parameters (WBC, RBC, HGB, HCT, PLT, RET and NRBC counts, Neu, Lym, Mon, Eos, Bas, RET and NRBC percentages) can be edited. After editing and saving the WBC differential parameters (%), the absolute values of the WBC differential parameters will be recalculated and renewed. Make sure the sum of the WBC differential parameters (%) edited is 100.00%. No matter the sample result is validated or not, as long as it is edited, the edited parameter result will be flagged with an "E". If any parameter result is changed due to the manual change of a parameter result, it will be flagged with an “e”. ("E" or "e" flags will be displayed in the “Flag” column.) You cannot edit the results of the background. Restore result (administrator) 1. Select the edited record from the “Table” or by specifying the “Date of Analysis” and “Sample ID”. 2. Click the "Restore Result" button, all edited results will be changed back into the initial values. NOTE The original measurement results of up to 2000 lately edited sample results can be saved by the analyzer. You cannot restore results of the background. Entry Option You can set the property of items displayed in the patient information area and how the information shall be entered by using the “Entry Option” button. Click the “Entry Option” button, and a dialog box will pop up.
Reviewing Sample Results 7-41 Set up the patient information items 1. Select/Deselect the “Unhidden” check box to display/not display the item in the patient information area. 2. Enter or select the “Default” if needed. 3. Select the “Memory” check box if needed, and then the patient information of the next sample will remain the same as the previous selected sample. 4. Click the “Text Display” and modify if needed. 5. Select the “Only get from dictionary” check box if needed, and then the entry of this item shall only come from the options set in data dictionary. Adjust the order of the items Select an item from the table on the left, and then use the order adjusting buttons to adjust the display order of the items in the patient information area. Selecting entry options You can select from the following options: Only enter bed No. for inpatients (which makes the entry of bed No. only enabled for inpatients) Double Validation Control (sample results must be operated and validated by
Reviewing Sample Results 7-42 different people) Operator can be modified (enable the modification of the “Operated by” field) Use the time of first print as the time of report Use the time when the report is printed as the time of report Switch to next sample after validation Communication 1. Select desired record(s) from the “Table”. 2. Click the "Communication" button to start transmitting the selected sample(s). Validate/Cancel (Administrator) To validate sample record(s) Select the sample record(s) to be validated from the “Table”, and then click the "Validate" button to validate. The validated record(s) will be highlighted. A dialog box will pop up asking for Administrator ID and password if the current user is of operator level. To cancel the validation of sample record(s) Select the validated sample record(s) from the “Table” and then click the "Cancel" button to cancel the validation and the highlight. Delete Sample Record(s) (Administrator) 1. Select the sample result(s) to be deleted from the “Table”. 2. Click the “Delete” button, and the following dialog box will pop up. 3. Click “OK” to close the dialog box and delete the record(s). New Para. If you have defined custom parameters in the custom parameter setup screen (“Setup” > “Para. Setup” > “Custom Para. Setup”), you can edit the results of these parameters and add them to the reported results. 1. Select the sample result(s) to be deleted from the “Table”.
Reviewing Sample Results 7-43 2. Click the “New Para.” button or [F6] on the keyboard, and the following dialog box will pop up. 3. Enter the results of custom parameters to the corresponding cell in the “Result” column. 4. If you want to add any of these parameters to the report parameters, select the corresponding check box in the “Add” column. 5. Click “OK” and the added custom parameters will be displayed at the end of the “Para.” Tab. Check the Print Preview 1. Select a record you want to check the print preview from the “Table”. 2. Click the “Preview” button to go to the preview screen. 3. Click “Close” to exit the preview screen. Batch Validation (administrator) 1. Click the “Batch Validation” button and the following dialog box will pop up.
Reviewing Sample Results 7-44 2. Specify the date on which the sample records you want to validate. 3. Specify the range of the “Sample ID” to be validated if needed. 4. Click “Validate” to validate the specified records and close the dialog box. Batch Print 1. Click the “Batch Print” button and the following dialog box will pop up. 2. Specify the date on which the sample records you want to print. 3. Specify the range of the “Sample ID” to be printed if needed. 4. Select a radio button to print as “Report” or “Table”. 5. Click “Print” to print the specified records and close the dialog box. Result compare You can compare the results with the same Patient ID and patient name attained within 6 months. 1. Select the record you want to do a comparative study from the “Table”. NOTE If there are records of the same sample, the “Result Compare” button will turn to red. 2. Click "Result Compare", a dialog box will pop up.
Reviewing Sample Results 7-45 3. If needed, specify the range of “Date of Analysis” and then click “Search” to search for the records of the same sample within that period of time. 4. Select from “Parameter Compare”, “Trend Graph” and “Scattergram/Histogram” radio buttons for different comparative view of the samples. 5. If needed, check the print preview and print the “Parameter Compare” and “Trend Graph” by using the “Print” and “Print Preview” buttons. 6. If needed, adjust the display order of the parameters in “Parameter Compare” and “Trend Graph” screens. Click the “Para. Order” button in the corresponding screen, and adjust the order of desired parameter(s) in the pop-up dialog box. Print Select the sample record(s) you want to print from the “Table”, and then click the "Print" button to print. Adjust View Click the “View” button, and then the following dialog box will pop up.
Reviewing Sample Results 7-46 To switch to another tab Click “Patient Info.”, Parameter", "Microscopic Exam.", "RUO Para.", "Table", “Intraday repeated results", or “Graphics” to switch to the corresponding tab. To restore default layout Click "Restore default layout" to restore the screen layout to default. To lock/unlock layout (administrator) The layout of the Review Screen is locked as default. You can click "Unlock Layout" to unlock the layout. When the layout is unlocked, you can adjust the location of any module by dragging it to the destination, or close the modules you don’t need to simplify the view. When the layout is unlocked, the “Unlock Layout” menu option will automatically change into “Lock Layout”. Click “Lock Layout” to disable the layout change function. 7.4.3 Right-Click Menu Functions Patient info. Area Right click in non-editable area of the patient info. area, the following menu will pop up.
Reviewing Sample Results 7-47 Set up the property Click “Property”, and a dialog box will pop up. You can set the property of items displayed in the patient information area and how the information shall be entered. See Entry Option of 7.4.2 Button Functions for details. Result display area Right click in the “Para.” tab of the result display area, the following menu will pop up. Add custom parameter results If you have defined custom parameters in the custom parameter setup screen (“Setup” > “Para. Setup” > “Custom Para. Setup”), you can edit the results of these parameters and add them to the reported results. 1. Click “Add”, and the following dialog box will pop up.
Reviewing Sample Results 7-48 2. Enter the results of custom parameters to the corresponding cell in the “Result” column. 3. If you want to add any of these parameters to the report parameters, select the corresponding check box in the “Add” column. 4. Click “OK” and the added custom parameters will be displayed at the end of the “Para.” Tab. Delete sample record(s) 1. Click “Delete”, and the following dialog box will pop up. 2. Click “OK” to close the dialog box and delete the record(s). Result table Area “Table” tab Select one or more records from the “Table” tab, and then right click. The following menu will pop up.
Reviewing Sample Results 7-49 Print Click “Print” to print the selected record(s). Validate/Cancel (administrator) If the selected record(s) is/are not validated, click “Validate” to validate. If the selected record(s) is/are validated, click “Cancel” to cancel the validation. Delete (administrator) Click “Delete” to delete the selected record(s). Data Communication Click “Communication” to communicate the selected record(s). Edit Sample ID (administrator) 1. Click "Edit Sample ID", the "Sample ID Edit" dialog box will pop up. 2. Modify the sample ID, and then click “OK” to save the change and close the dialog box. Apply reexam rules 1. Click "Apply reexam rules", the software will automatically apply current reexam rules (configured in “Setup” > “Reexam Rules”) to the selected record(s). 2. For records suggested to be reexamined, the text color in the “Table” will change into
Reviewing Sample Results 7-50 red and there will be a message on top of the screen. NOTE Before performing the "Apply reexam rules" function, make sure the rules are enabled on the reexam rules setup screen. For the samples that are required to be reexamined, reexamine them according to laboratory procedures. Error Alarm (operator)/Special Info. (administrator) The operator can check the error messages reported during the analysis of the selected sample by clicking “Error Alarm”; the administrator can check the error messages, as well as other special information in the process of sample analysis (like the HGB blank voltage, aperture voltage, etc.) by clicking “Special Info.”. Switch to review Click “Switch to review” switch to the review screen of the last selected record. Refresh Click “Refresh” to refresh the “Table” area. “Intraday repeated results” tab Select a record in the record table area, and then right-click. Set the report record You can set any record in the list to be the report record. 1. Select the desired record from the record table area. 2. Right click in the record table area, and select “Match repeated results”, and then the selected record will be ticked. Delete repeated results 1. Select the desired record from the record table area.
Reviewing Sample Results 7-51 2. Right click in the record table area, and select “Delete repeated results”, and then a dialog box will pop up asking you to confirm the deletion. 3. Click “OK” to delete the selected record and exit. Transmit repeated results 1. Select the desired record from the record table area. 2. Right click in the record table area, and select “Transmit repeated results” to transmit the results of the selected record. Print repeated results 1. Select the desired record from the record table area. 2. Right click in the record table area, and select “Print repeated results” to print the results of the selected record. Edit sample ID 1. Select the desired record from the record table area. 2. Right click in the record table area, and select “Edit sample ID”, and then a dialog box will pop up. 3. Edit the sample ID in the text box and click “OK” to save the change. Since the previously selected sample ID has been changed, it will be excluded in the repeated results.
Reviewing Sample Results 7-52 7.5 Statistics You can check and print the following summaries from the "Statistics" screen of the DMU: Workload Summary Summary of Positive Samples General Summary 7.5.1 Workload Summary（"Statistics" > "Workload Summary"） 1. Specify one or more conditions to generate the "Workload Summary": Analyzer Date of Analysis Department Ward Operated by Validated by Sample Type Patient Type Delivered by 2. Click "OK", and then the matching results will be displayed in the summary area below the conditions.
Reviewing Sample Results 7-53 7.5.2 Summary of Positive Samples 1. Specify one or more conditions to filter the records: Analyzer Name Date of Analysis Item (parameter) Sample Type Department 2. Select one of the following radio buttons: Identify Positive Samples Based on Reexam Rules Custom Rules for Positive Samples If you want to "Identify Positive Samples Based on Reexam Rules", make sure the desired reexam rules are "Applied" in the reexam rule setup screen. If "Custom Rules for Positive Samples" is selected, edit the conditions of positive samples in the custom area below. 3. Click "OK", the matching results will be displayed in the summary area below the conditions. 7.5.3 General Summary 1. Specify one or more conditions: Analyzer Sample ID Date of Analysis
Reviewing Sample Results 7-54 Name Patient ID Gender Ref. Group Sample Type Department Ward Delivered by Operated by Validated by 2. Specify one or two statistical items from the pull down list(s). The statistical item is used by system to categorize the results meeting the filtering conditions set in Step 1. E.g. if you select “Gender” as "Statistical Item 1", and the “Gender” filtering condition is not defined, the table below will list the filtered records in different genders. 3. Click "OK", the matching results will be displayed in the summary area below the conditions. 7.5.4 Print Summary Print Preview Click the "Preview" button, the "Print Preview" window will pop up displaying the preview of the summary results. Click the “Close” button to close the window. Print Click the "Print" button to print the summary results.
8-1 8 Using the QC Programs 8.1 Introduction Quality Control (QC) consists of strategies and procedures that measure the precision and stability of the analyzer. The results reflect the reliability of the sample results. QC involves measuring materials with known, stable characteristics at frequent intervals. Analysis of the results with statistical methods allows the inference that sample results are reliable. Mindray recommends you run the QC program daily with low, normal and high level controls. A new lot of controls should be analyzed in parallel with the current lot prior to their expiration dates. This may be accomplished by running the new lot of controls twice a day for five days using any empty QC file. The QC files calculate the mean, standard deviation and coefficient of variation for each selected parameter. The instrument-calculated means of these ten runs should be within the expected ranges published by the manufacturer. The BC-6800 analyzer provides 5 QC programs: L-J QC, X QC, X -R QC, X-B QC and X-M QC. You can only perform QC analysis on the analyzer, the QC setup and QC result review operations must be done on the PC.
Using the QC Programs 8-2 8.2 L-J QC Program 8.2.1 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 L-J program, you should set a QC file for each lot of controls. 1. Click "QC”, and then select "L-J 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 L-J QC setup screen.
Using the QC Programs 8-3 To set up the QC file, you shall enter the required “File Info.” and “Target/Limit” using one of the following ways: Reading the information provided by the manufacturer Manual entry Reading the saved preset values. 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) Reading the information provided by the manufacturer 1. Click "QC”, and then select "L-J 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 L-J QC setup screen.
Using the QC Programs 8-4 3. Select an empty QC file (ranging from 1 to 60) from the “File Info.” table. 4. Click the “Read File” button, a message box will pop up. 5. Click the "Browse" button, and then select the path to read QC information. 6. Click "OK" to close the box, the dialog box below will display.
Using the QC Programs 8-5 NOTE The QC files for selection are displayed in the format of "Batch No. (level)". 7. Select a QC file and click "OK" to close the dialog box and return to the "Read File" dialog box. The path selected will be displayed. 8. Select "Read Target/Limit", and then click "OK" to import the QC information into the current QC file.
Using the QC Programs 8-6 NOTE If the “Read Target/Limits” is not selected, you have to enter the target and limits manually. 9. Select the source of control from the pull-down list. 10. 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). 11 Set QC sample ID: if you are used to analyze control together with blood samples, you can set a unique ID for the control. The analyzer will recognize the sample as control when it reads the unique ID. After the analysis completes, the results will be saved into the QC file of the QC sample ID. NOTE Letters, numbers and all characters that can be entered with the keyboard are allowed for the special ID, but the ID must end with a number except "0".Chinese and other languages are not supported (e.g. Japanese, Korean, etc.) 12. Tick the “In Use” box if needed. NOTE For files having the same “Level”, presentation mode (OV or AL) and “QC Sample ID”, only one of them can be “In Use”. 13. Click the “Save” button to save the QC information. NOTE The expiration date shall not be earlier than the current system date. Manual entry 1. Click "QC”, and then select "L-J 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 L-J QC setup screen.
Using the QC Programs 8-7 3. Select an empty QC file (ranging from 1 to 60) from the “File Info.” table. 4. 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. 5. Select the control level from the pull-down list (L for low level, N for normal level and H for high level). 6. Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control. 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. 7. Select the source of control from the pull-down list. 8. 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).
Using the QC Programs 8-8 9. Set QC sample ID: if you are used to analyze control together with blood samples, you can set a unique ID for the control. The analyzer will recognize the sample as control when it reads the unique ID. After the analysis completes, the results will be saved into the QC file of the QC sample ID. NOTE Letters, numbers and all characters that can be entered with the keyboard are allowed for the special ID, but the ID must end with a number except "0" .Chinese and other languages are not supported (e.g. Japanese, Korean, etc.) 10 Tick the “In Use” box if needed. NOTE For files having the same “Level”, presentation mode (OV or AL) and “QC Sample ID”, only one of them can be “In Use”. 11. Enter the targets and limits manually according to the package insert for the batch of controls. 12. Click the “Save” button to save the QC information. Reading the saved preset values NOTE If there are the saved preset values (Target and Limits) for the current level, you can read-in the preset values into the current QC file. For details of calculating and saving the preset values, see Section 8.2.3 Review L-J QC Results. 1. Click "QC”, and then select "L-J 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 L-J QC setup screen.
Using the QC Programs 8-9 3. Select an empty QC file (ranging from 1 to 60) from the “File Info.” table. 4. 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. 5. Select the control level from the pull-down list (L for low level, N for normal level and H for high level). 6. Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control. 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. 7. Select the source of control from the pull-down list. 8. 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
Using the QC Programs 8-10 abbreviations). 9. Set QC sample ID: if you are used to analyze control together with blood samples, you can set a unique ID for the control. The analyzer will recognize the sample as control when it reads the unique ID. After the analysis completes, the results will be saved into the QC file of the QC sample ID. NOTE Letters, numbers and all characters that can be entered with the keyboard are allowed for the special ID, but the ID must end with a number except "0" .Chinese and other languages are not supported (e.g. Japanese, Korean, etc.) 10. Tick the “In Use” box if needed. NOTE For files having the same “Level”, presentation mode (OV or AL) and “QC Sample ID”, only one of them can be “In Use”. 11. Click the “Get Preset Values” button to read in the saved preset targets and limits (corresponding to the current level) into the current QC file. NOTE If some parameters to be included in the QC run have no preset values, you should enter the target and limits for them manually; if you don't want some parameters with preset values to be included in the QC run, you can delete the target and limits of those parameters manually after read-in the preset values. 12. Click the “Save” button to save the QC information. Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1. Click the “Set Limits” button, and then the following dialog box will pop up.
Using the QC Programs 8-11 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. 8.2.2 L-J QC Run You can select one of the two ways below to run controls: Run controls under the "QC" screen Put controls together with normal samples, and run the controls under the sample analysis screen. 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.
Using the QC Programs 8-12 Exercise caution to avoid contact with the probe when working around it. 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 Under open vial mode, make sure the volume of the control is no less than 0.5mL; under autoloader mode, make sure the volume of the control is no less than 1mL. Running controls with errors occurred may lead to incorrect analysis results. If errors occur during the QC analysis process, be sure to remove the errors first and then proceed with the QC run. Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. 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. Only the controls specified by Mindray can be used. Using controls of other manufacturers may lead to incorrect QC results. Store and use the controls as instructed by instructions for use of the controls. Be sure to keep dust from the prepared diluent. After mixing the control with the diluent, be sure to wait 3 minutes before running. Be sure to run the prediluted samples within 30 minutes after the mixing. Be sure to mix any sample that has been prepared for a while before running it.
Using the QC Programs 8-13 Run controls under the "QC Run" screen After editing the QC information, you can start QC analysis by one of the following ways according to the selected QC mode. OV-WB OV-PD AL-WB (Without Built-in Barcode Scanner) AL-WB (With Built-in Barcode Scanner) 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. OV-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. 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
Using the QC Programs 8-14 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. 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. 1. Tap the MENU button on the screen, and then select "QC" on the pop-up menu. 2. Tap "Setup" button, the QC setup dialog box will pop up.
Using the QC Programs 8-15 3. Select “QC Type” as "L-J QC" and select the QC file of the control to be run, and then tap "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. 5. Run QC analysis: 1) Make sure the analysis mode is "OV-WB" and the indicator of the analyzer is green. 2) Shake the vial of the whole blood sample as instructed by the picture below to mix the sample thoroughly. 3) Tap "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
Using the QC Programs 8-16 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. 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
Using the QC Programs 8-17 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. 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. Tap the MENU button on the screen, and then select "QC" on the pop-up menu. 2. Tap "Setup" button, the QC setup dialog box will pop up.
Using the QC Programs 8-18 3. Select “QC Type” as "L-J QC" and select the QC file of the control to be run, and then tap "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) Accommodate the prepared control into the rack. 4) Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer. 5) Tap the "Start Count" button on the dialog box to start running. 6) When finish running, you can remove the racks from the left of the autoloader. 6. When finish running, the newest 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.
Using the QC Programs 8-19 7. Do the above procedures to continue running QC analysis if necessary. Put controls together with normal samples, and run the controls under the sample analysis screen. After setting special "QC Sample ID" for a control under the QC setup screen, you can put the control together with normal samples, and run it under the “Count” screen. Based on the QC mode selected, you can choose to run QC analysis from one of the following ways: OV-WB AL-WB NOTE Worklist is not supported in QC sample analyses. OV-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. 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