TM-2430-13 (Doctor Pro) Ambulatory Blood Pressure Monitor Data Analysis Software INSTRUCTION MANUAL WM:PD4000019C
CONTENTS 1. INTRODUCTION .........................................................................................................3 1-1 About the Data Analysis Software...................................................................................................3 1-2 Symbols ...........................................................................................................................................4 1-3 Monitoring Device Review..............................................................
2-7 Recorder Menu ............................................................................................................................. 31 2-7-1 Retrieving Data from the Monitor............................................................................................... 32 2-7-2 Clearing The Monitor’s Memory ................................................................................................ 33 2-7-3 Programming the Monitor’s Intervals and Conditions....................................
1. INTRODUCTION 1-1 About the Data Analysis Software Welcome to the Ambulatory Blood Pressure Monitor (ABPM) Data Analysis Software. This software is intended for use with the following devices. ABPM: For diagnosing high blood pressure 1) A&D TM-2430 Series Ambulatory Blood Pressure Monitor 2) A&D TM-2420/TM-2421 Ambulatory Blood Pressure Monitor and the TM-2020/TM-2021 Printer/Processor/Interface (hereafter referred to as "processor").
1-2 Symbols The symbols printed on the device have the following meaning: CE marking SN Serial number 1-3 Monitoring Device Review The following section briefly reviews the devices and how they may be used with this software. A&D Ambulatory Blood Pressure Monitors are used to record an individual’s blood pressure over an extended period of time, normally 24-72 hours. The monitor is worn by the patient.
1-4 Software Package Components Items included in your complete software package are: ♦ ABPM 3.
2. OPERATING PROCEDURE 2-1 Getting Started Two initial actions may be executed when starting up the software: (1) Data may be retrieved from the monitor. (2) Stored data files may be opened and viewed for analysis.
Step 1 Connect the monitor to the processor. Step 2 Connect the male end of the A&D-supplied RS-232C communication cable to the processor. Step 3 Connect the female end of the A&D-supplied RS-232C communication cable to the computer. Step 4 The display on the processor will show “0-----”. If the processor does not have a display, the LED should be green. If the LED is not green or the “0-----” does not appear, see “3-2 Communication Errors”. If the processor shows “0-----”, go to step 5.
Step 3 The display on the monitor will show “----”. If “----” does not appear, see “3-2 Communication Errors”. Otherwise go to step 4. Note: If possible, keep the cable connected to the computer unless the port is needed for other functions. Step 4 Run the software. Step 5 Confirm that the correct serial port and the correct monitor type are set. For details, see “2-9-4-2 Serial Port” and “2-9-4-3 Recorder Type”.
2-3 Main Screen Description The main screen is comprised of six menus and two toolbar buttons located permanently along the top of the screen. These menus may be used to access the various features of the software. The toolbar buttons may be used to set Partial Analysis and Blood Pressure Mode parameters.
2-4 Toolbar There are two toolbar buttons which appear underneath the main menu bar: (1) Analysis Intervals (2) BP Mode 2-4-1 Analysis Intervals The Analysis Intervals feature is used to define specific periods of time within an opened data file for custom data analysis. Two intervals, Full Analysis and Partial Analysis may be defined for each data file.
♦ Histograms After Partial Analysis parameters are defined, the data specified within the parameters will appear in red overlaying the Full Analysis data. 2-4-2 BP Mode The BP Mode is used to select which blood pressure method will be used as the primary and secondary choices for displaying the blood pressure measurement data. A&D monitors employ either Korotkoff, oscillometric or dual Korotkoff and oscillometric measurement methods.
To specify the BP Mode while viewing an opened data file, complete these steps: Step 1 Select the BP Mode box on the toolbar. Step 2 Select the desired BP Mode used to view and analyze the opened data file. Figure 5: BP Mode selection on toolbar To set a default BP Mode for the software at startup, see “2-9-4 Default Settings”. Note: The BP Mode for printed reports is assigned separately in the Report Format Setup. See “2-8 Report Menu”.
2-5-1 Open The File | Open function is used to access the blood pressure data within existing data files. Figure 6: File Open dialog box To open a file, complete the following steps: Step 1 Select the File menu. Step 2 Select the Open sub-menu. Step 3 Select a file from the directory shown or move to a different directory. Step 4 Click the Open button. Note: The File | Save As, View and Report menus and Analysis Intervals buttons are disabled until a data file is opened.
2-5-4 Convert The File | Convert function is used to create a .CSV (comma delimited) format file from a .dat file that is compatible with most spreadsheet applications, including Microsoft Excel™. The .CSV file that is created includes DATE, TIME, SYS, DIA, MAP, PUL headings so that the data can be identified correctly when opened in a spreadsheet. The original file will not be modified in any way.
2-5-6 Print The File | Print function is used to print reports for one or more data files according to a userselected format. This enables the user to generate multiple reports without having to open each file separately. To print a report for multiple data files, complete the following steps: Step 1 Select the File menu, then select the Print sub-menu.
2-6 View Menu The View menu may be used to view numerical, statistical and graphical data screens. The View menu is disabled unless a file is opened. For information on how to open a file, see “2-5-1 Open”. The View menu has the following sub-menus: Menu Summary Data See “2-6-1 Summary Data” Description Function for viewing statistical data. BP Data List “2-6-2 BP Data List” Function for viewing numerical data and entering comments.
2-6-1 Summary Data The Summary Data screen includes statistics on the data of the opened file and may be viewed directly on the screen. These statistics are separated into four data tabs: Full Statistics based on all the data within the file. Partial Statistics based on the data specified in the Partial Analysis parameter. See “2-4-1 Analysis Intervals”. Awake Statistics based on the data during the waking hours. Note: Waking hours are specified as those hours outside the identified sleeping hours.
Each of the four Summary Data is titled with the name of the tab, file, patient and measurement method. For detailed information on Summary Data screen listings, see below: Summary Data Tab Time Interval Definition The analysis period, start time/date – end time/date, for the activated Summary Data tab. Valid Readings The total number of measurements taken during the monitoring session less any monitoring errors or manually excluded readings within the data set.
2-6-2 BP Data List The BP Data List function displays individual blood pressure measurement within an open data file in tabular form. With the BP Data List, you may input measurement comments, exclude/include a measurement within the graphics and statistics or link a measurement to the beginning of the Trends Screen.
Figure 9: Blood Pressure Data List display 2-6-2-1 Excluding/Including BP Measurements It is useful to exclude a measurement from the Blood Pressure Data List in cases where the measurement is clearly incorrect. The software provides a simple way to include or exclude measurements while viewing a list. When a measurement is excluded from the Blood Pressure Data List, it will not be included in any of the software’s statistical or graphical analysis functions.
2-6-2-3 Linking to Trends Screen A measurement may be linked to the Trend Graph by highlighting an individual measurement and then closing the Blood Pressure Data List. When opened, the Trends Screen will be aligned with the time of the highlighted measurement in the Blood Pressure Data List. This feature may be used to pinpoint the position of an individual measurement on the Trend Graph.
Delimitation, Scroll Bar and Linking ♦ Partial Analysis: When the Partial Analysis feature is enabled, red bands will appear on all the Trend Graphs highlighting the period and data specified within the Partial Analysis parameters. ♦ Sleep: When the Sleep interval is identified, black bands will appear around all the Trend Graphs highlighting the specified Sleep interval.
2-6-3-1 Viewing the Trends Step 1 Select the View menu. Step 2 Select the Trends sub-menu. Step 3 You may print the Trends Screen by selecting the Print menu on the Trends toolbar. Step 4 Click the Windows™ close button in the top right corner to close the Trends Screen. 2-6-3-2 Scaling the Screen The Trends Screen may be scaled to have some or all of the data fit on the screen. To scale the Trends Screen, complete the following steps: Step 1 Select the Zoom drop-down menu on the Trends toolbar.
To customize the Trends Screen, complete these steps: Step 1 Select the Select menu on the top left hand corner of the Trends toolbar. Step 2 Highlight the Trend Page Template you want to view and click the OK button or double click the Trend Page Template. If an existing template does not meet the requirements, you may create a new template or edit an existing one. 2-6-3-4 Creating a New/Edit Trends Template The new and edit Trend Page features are quite similar.
Figure 13: Blood Pressure Trend Setup dialog box Step 8 Repeat steps 6-7 to set positions 2, 3, and 4. Step 9 To save your trend template, click the Save button Step 10 To cancel the operation, click the Cancel button . 2-6-4 Correlation Plots The Correlation screen offers a convenient way to view the relationship between the Blood Pressure parameters. It also assesses overall performance of the patient’s cardiovascular system.
measurements. Measurement statistics, Mean " m ", Standard Deviation " s’ " and Correlation Coefficient “ r ” values are shown on the bottom of the screen.
2-6-5 Histograms The Histograms screen offers a convenient way to quickly review the overall magnitude and distribution of the systolic, diastolic, mean arterial blood pressures and pulse (heart rate) measurements. The following Histograms are available: ♦ Systolic Blood Pressure: Full Analysis in blue, Partial Analysis overlaid in red. ♦ Diastolic Blood Pressure: Full Analysis in blue, Partial Analysis overlaid in red.
2-6-6 Circadian Rhythm The Circadian Rhythm screen shows the circadian rhythm of the systolic and diastolic blood pressures, and pulse (heart rate); obtained using the 24-hour cosinor analysis. The analysis starting time coincides with the start time specified for the Full Analysis interval. The Circadian Rhythm screen also shows the amplitude and peak value of the cosine wave based on the 95% confidence interval.
2-6-7 HIB Analysis The HIB analysis screen shows two graphs arranged vertically. The upper graph shows the hyperbalic area (in red) exceeding the user-defined hyperbalic limits for the systolic and diastolic blood pressures, and the numerical data converted into a one-day period. The lower graph shows the hypobalic area (in red) not reaching the user-defined hypobalic limits for the systolic and diastolic blood pressures, and the numerical data converted into a one-day period.
2-6-8 Patient Information The Patient Information screen is used to store information on patients and their treatment. This is also the input screen for the patient’s Sleep interval. Figure 18: Patient Information display The Patient Information screen has the following data fields: (The characters referred to in the table below include CRs and spaces.) Field Recorder ID Description Recorder ID refers to the monitor identification number. The Recorder ID cannot be modified in this screen.
Field Insurance Description Field for the patient’s insurance information. Up to 20 characters can be used. Medicare # Field for the patient’s Medicare or Medicaid number or other health care number. Up to 20 characters can be used. Medications Field for the patient’s medications. Up to 60 characters can be used. Age Field for the patient’s age. Up to 10 characters can be used. Sex Field for the patient’s sex. Up to 10 characters can be used. Height Field for the patient’s height.
2-7-1 Retrieving Data from the Monitor Figure 19: Recorder-Retrieve Data dialog box See below for the description of each field on the Recorder-Retrieved Data dialog box. Field Description Recorder ID Recorder ID is set in the monitor’s memory prior to the monitoring session. Start Date Date of first measurement in the monitor’s memory. Start Time Time of first measurement in the monitor’s memory. Patient Name Field for the patient’s name.
Step 7 Click the OK button. Note: To view a retrieved file, you must open it. 2-7-2 Clearing The Monitor’s Memory The monitor’s memory should be cleared before each monitoring session. With the monitor and the processor connected to the computer, you may clear the measurement data stored in the monitor by completing the steps below: Step 1 Select the Recorder menu. Step 2 Select the Clear Data sub-menu.
2-7-3 Programming the Monitor’s Intervals and Conditions 2-7-3-1 TM-2420/TM-2421 Setup With the monitor and the processor connected to the computer, you may setup or change the following monitor condition and interval settings: Item Definition Recorder ID number Monitor (or patient) ID number (01 through 99). This is useful when more than one monitor is used in the same clinical setting. Time Sets monitor’s internal clock. Date Sets monitor’s internal calendar.
Figure 21: TM-2420/TM-2421 Recorder Setup dialog box Step 3 Select the Recorder ID field. Input a Recorder ID number between 1 to 99. Step 4 Select the Display check box to set the display to On or Off. Step 5 Select the Buzzer check box to set the buzzer On or Off. Step 6 Select the Time field for Period One (1) and enter the time you want the monitoring session to begin. Use military time to set the Time.
Step 13 Select the Interval drop-down menu for Period Three (3) and set the measurement Interval for Period Three (3) to: OFF, 1, 3, 5, 10, 15, 20, 30, 60 or 120 minutes. Step 14 If you want to program a fourth period, go to step 15. If you do not want to program a fourth period, go to step 17. Step 15 Select the Time field for Period Four (4) and enter the time you want for this period; the end period for Period Four (4) will be the Time for Period (1). Use military time to set the Time.
2-7-3-3 Examples of Programming the Monitor Note: The procedure is the same for the TM-2420/TM-2421/TM-2430, except periods 5 and 6, which are available only with the TM-2430. (A) Example: Programming the Monitor for One (1) Period Suppose that the start time of the monitoring session is 09:00 and you would like the monitor to measure the patient's blood pressure every 30 minutes. Remember that the Time for Period One (1) also defines the End of the monitoring session.
(B) Example: Programming the Monitor for Three (3) Periods Suppose that the start time of the monitoring session is 09:00 and you would like the monitor to measure the patient's blood pressure every 30 minutes until 22:00, and from 22:00 to 07:00 once an hour, and from 07:00 you would like the blood pressure measured every 15 minutes. Remember that the Time for Period One (1) also defines the End of the monitoring session.
(C) Example: Programming the Monitor for Four (4) Periods Suppose that the start time of the monitoring session is 09:00 and you would like the monitor to measure the patient's blood pressure every 30 minutes until 22:00, and from 22:00 to 23:00 you want the monitor OFF so that the patient may sleep, and from 23:00 to 06:00 you would like the patient's blood pressure measured once an hour, and finally from 06:00 you want the blood pressure measured every 15 minutes.
2-7-3-4 UA-767PC Setup When the UA-767PC connected to a personal computer, times to generate a beeping sound can be set. To set the times, complete the following steps: Step 1 Select the Recorder menu. Step 2 Select the Setup sub-menu. The Recorder Setup dialog box appears. Figure 26: UA-767PC Recorder-Setup dialog box Step 3 Enter times to generate a beeping sound. Note: The same time can not be entered in different boxes. Enter different times for each box.
2-8 Report Menu Custom report formats may be saved for future use through the Report menu.
2-8-1 Creating a New Report Template Step 1 Click the New button on the Report dialog box. The Report Setup dialog box will appear. Figure 28: Report setup dialog box Step 2 Type the Report Name. Step 3 Edit the Report Heading. This heading will appear on the top of every page along with the file name and time the file is printed. Step 4 Select the Text Data you want included in the report by checking the appropriate boxes. Note: You may check all or none of these boxes.
2-8-2 Editing an Existing Report Template Step 1 Highlight the report template you want to edit. Step 2 Click the Edit button. The Report Setup dialog box will appear. Step 3 Edit the Report Name. Step 4 Edit the Report Heading. The Report Heading will appear on the top of every page along with the file name and time the file printed. Step 5 Edit the selected Text Data you want included in the report by checking or unchecking the appropriate boxes. Note: You may check all or none of these boxes.
2-9 Options Menu The Options menu may be used to access default and various formatting screens within the software. The following Options features are available: Menu Report Formats See “2-8 Report Menu” Description The Report formats may be used to create and save custom report formats. Physicians List “2-9-2 Physician List” The Physicians list may be used to store contact information on the patient’s physician, i.e.
The following instructions outline the various Physician List features available. 2-9-2-1 Adding a New Physician to the List Figure 30: Physician Entry dialog box Step 1 Click the New button on the Physician List dialog box. The Physician Entry dialog box will appear. Step 2 Enter the appropriate data. Note: All fields must be completed. Step 3 Save the new physician template in the list by clicking the Save button. If you do not want to save the new physician, click the Cancel button.
2-9-4 Default Settings There are three default settings in this software: 1) Blood Pressure 2) Serial Port 3) Recorder Type 2-9-4-1 BP (Blood Pressure) Settings (Available only for TM-2420/TM-2421 and TM-2430 data) Edit the Default Blood Pressure Settings as follows: Step 1 Select the Measurement Method (BP Mode). Step 2 Enter data for each value. The following is the description of each value.
2-9-4-2 Serial Port The serial port is used to communicate between the monitor and the computer. The serial port setting and the port used for communication must be the same. Figure 32: Default Serial Port Selection dialog box 2-9-4-3 Recorder Type Figure 33: Default Recorder Type dialog box The default Recorder Type function is used to select the type of monitor the software will communicate with for all Recorder functions.
3. TROUBLESHOOTING 3-1 Measurement Errors The following tables list the error messages that may occur during a monitoring session and offer information on possible causes and corrections. Measurement errors may be shown on the blood pressure data list display and printed text data. If an error occurs (indicating by asterisks), corrective measures must be taken to use this software.
ERROR CODE E07 POSSIBLE CAUSE Manual stop E08 Korotkoff undetectable. E11 More than 256 Korotkoff sounds are measured. E20 Pulse Error Pulse less than 35 beats or more than 200 beats per minute. E21 Diastolic greater than 160 mmHg or less than 40 mmHg. Systolic greater than 280 mmHg or less than 60 mmHg. Difference between systolic blood pressure and diastolic blood pressure less than 10 mmHg. Difference between systolic blood pressure and diastolic blood pressure greater than 150 mmHg.
3-1-2 TM-2430 Series Error Codes ERROR CODE E00 POSSIBLE CAUSE Clock parameters have not been set. An error code is displayed without cuff inflation. Measurement is stopped due to a low battery. CORRECTION Enter clock parameters. E07 Controlled stop using STOP key Do not press the STOP key when unnecessary. E08, E10 Pulse can not be detected. Do not move and try to relax during the measurement. E20 Pulse less than 35 beats or more Measure the blood pressure by other than 200 beats per minute.
3-2 Communication Errors When communicating between the monitor and the PC, the following dialog box may appear if the communication setup is not performed properly: Figure 34: Communications Error dialog box If this error occurs, complete the steps below: Step 1 Click the OK button on the Error dialog box. Step 2 Check the monitor's battery. Recharge the battery if necessary. Or replace with new batteries. Step 3 Check the Default Serial Port selection. Make sure it is correct.
3-3 Missing Files If you can not find your files in one of the File menu screens, and the files have not been deleted, check the following: ♦ The folder specified in the Recorder-Retrieved Data dialog box is the same folder as specified using the File | Open function. ♦ No changes have been made to the file extension .dat. 3-4 Reports Are Not Printing With the Desired BP Mode It is important to note that the toolbar BP Mode is separate from the Report Format BP Mode settings.
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Figure 37: Summary data (Full and partial) – Text data 54
Figure 38: Summary data (Awake and sleep) – Text data 55
Figure 39: Blood pressure data – Text data 56
Figure 40: Trend graph (Blood pressure and double product) – Graphical data 57
Figure 41:Correlation plots (upper) and histogram plots (lower) – Graphical data 58
Figure 42: Circadian rhythm plots (upper) and HBI analysis plots (lower) – Graphical data 59
Figure 43: “Mini” report -1 60
Figure 44: “Mini” report -2 61
5. TERMS/ABBREVIATIONS 5-1 Terms Related to Blood Pressure Term/Abbreviation Oscillometric Description Oscillometric method of blood measurement. Korotkoff method of blood measurement. Blood pressure that occurs when contracts. Blood pressure that occurs when expands. Mean blood pressure obtained equation below.
Term/Abbreviation CORRELATION: r (Coefficient of Correlation) Sys – dia Sys – pul Reg. Line (Regression Line) Histogram F P Description Indicates the degree of linear relationship between two variables. It ranges from +1 to -1. A correlation of +1 means that there is a perfect positive linear relationship between variables. In the plotted 24-hour blood pressure data, indicates high blood pressure using the limits of the systolic and diastolic blood pressures.
Term/Abbreviation c.i., Confidence Interval Description Interval surrounded by the confidence limit of 95%. 95% confidence interval is expressed in numerical data with the cosinor analysis graph. PR (Percent Rhythm) Rhythm compatibility Squared multiple correlation coefficient (R) between the measured value and the cosine curve best fitted to the biological rhythm data. The closer to one a PR value is, the better a regression line fits. For example, when a PR value is greater than 0.
5-4 Terms Related to the Risk Management of High Blood Pressure Term/Abbreviation Hyperbalic Index, HBI Hypobalic Index Hyperbalic Area Hypobalic Area HBI-sys HBI-dia Description High blood pressure index Low blood pressure index Time integral of the blood pressure values exceeding the limits. 24-hour blood pressure data is plotted on a trend bar graph and an integral is performed on the area exceeding the userdefined limits. Expressed as an index per day.
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