Uro Report Guide

Document No.: NS01306D.OPI Date: 15 July, 1999

Neomedix Systems Pty. Ltd. Location :

Unit 13, No 1 Vuko Place Warriewood N.S.W, 2102 Australia Postal Address : P.O. Box 890 Mona Vale N.S.W. 1660 Australia Telephone : National : (02) 9913 8044 International : +612 9913 8044 Facsimile : National : (02) 9913 7818 International : +612 9913 7818 email : [email protected]

www.neomedix.com ABOUT THIS MANUAL This manual is specific to UroReport version 3.1.9. Consequently it may appear substantially different if you are using a different version of the software. To check which version of UroReport you have, first launch Uromac, then select "About Uromac…" from the Apple Menu, and click on the jigsaw puzzle shaped extension button. You should see UroReport in the list of installed extensions. If it is not there, you probably need to install the software (see Appendix A.), if it is, click on the UroReport entry. The version of the software will now be displayed. If the UroReport version is earlier than version 3.1.9 you should enquires about a software upgrade. If it is later than version 3.1.9 then use this manual with caution. A later revision of this manual may be available or at least some page inserts describing the updates. This manual assumes that you are familiar with the operation of the Apple Macintosh computer. If you are unsure about the use of menus and dialogues then you should run the Macintosh tuition program that was supplied with your system. A fundamental understanding of the Macintosh environment is required to use UroReport as supplied. A more detailed knowledge is required to customise reports and to export formatted data. Note that some of the dialogue boxes shown in this manual will appear differently depending on the version of MacOS you are running.

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TABLE OF CONTENTS Page No 1. Introduction

4

2. Configuring the Report

5

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

Customising Comments Patient demographics Report details Fill phase Void Phase Urethral pressure profiles Video Micturating Cystogram Summary comments

5 7 8 9 10 11 12 13

3. Report creation and Data Transfer

14

3.1 3.2 3.3 3.4

Analysing your data More on automatic analysis More on manual analysis Checking the data points transferred

14 16 16 16

4. Saving a Report

19

5. Saving the Setup

20

6. Printing/Previewing a Report

21

7. Opening an Existing Report/File

22

8. Editing a Report

22

9. Archiving your data

22

10. Import/Export

23

Appendices: A - Installing UroReport B - Internal Calculations C - Report Messages D - Troubleshooting E - Internal Data Format F - Export Data Format G - Data Point Diagrams

24 25 32 34 35 41 44

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1.

INTRODUCTION

UroReport is designed to simplify Urodynamic report generation and presentation. It is used with Uromac application software to extract measurements from acquired waveforms, automatically carry out any derived calculations and to provide a suitable report form for all the necessary patient information. The prepared reports can be subsequently edited, printed and saved. UroReport has been designed to conform with the International Continence Society recommended terminology for Urodynamic studies. For the convenience of those whose clinical protocols do not carry out all the procedures itemised in the ICS standard, UroReport can be customised, to determine which data points appear in the report. Space is also provided for free-form text comments to be entered. All report data is conveniently stored within the waveform file and is loaded automatically when a file is opened.

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2.

CONFIGURING THE REPORT

To create a report you must first launch Uromac, then select Report Setup from the Patient Report menu as shown in Fig.1.

Fig.1. Select Report Setup from the Patient Report menu.

After selecting the Report Setup window you will see a line of buttons across the top of the dialogue box. These are used to select which of eight different report areas you are viewing. 2.1

Customising Comments

The Customise Comments function enables the user to create and alter definable pop-up menus. These can be used for storing pre-defined comments in the Video and Comments phase, as well as a pre-defined lists of Doctors, Technicians, and Locations within the Patient and Report Demographics. The pop-up Set menus contains comments (ie. Comment and Video comment Phase) or report setup information (ie. Referring Doctor, Department, Hospital/Institute). Note:

The pop-up Set menus are empty when you first start Uromac, and stay empty until the user defines them through the Customise Comments window and saves the options with the settings file. To customise comments select the Report option of the Report Setup window, as shown in figure 2 below.

Fig.2. Report Setup window.

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Press the Customise Comments button to the right of the window. You will then have the following window appear.

Fig.3. Customise Comments window.

The radio buttons on the right show the comment areas that can be customised. In the lower right corner of the window is a number that shows the available comment spaces free in each list. The pop-up menu shown by the Set menu contains a list of pre-defined comments and terms from which the user can form a customised list. Further, the user can combine these items with their own free text to generate their own list. This list is then accessible at the time of patient report generation. To enter comments into a desired list, you must first select the list that you wish to edit (ie. select a radio button, for instance ‘Refering Doctor’). The items being added to the selection list are displayed in the editable field on the left of the customise window. Note that sometimes the cursor does not display in the Comment entry box, type and test to see if you are in the correct place. To add a comment to this menu either type in free text, select a predefined comment from the resource list or use a combination of the two. Simply press the ‘Add’ button and the desired text will appear in the customised list. To remove a comment from the list, simply click on the comment you wish to remove in the list, and click the ‘Delete’ button. Alternatively to edit a comment that has been added to the list, click on the comment and then alter the comment and click the ‘Add’ button. Note:

As you add comments to the list the amount of available space will begin to decrease. A maximum amount of 10 entries a r e allowed per list.

Switch between lists at any time by clicking onto another radio button. Once the list has been created, press ‘OK’ to save the lists and to exit the Customise window. Click the ‘Cancel’ button if you want to exit without saving the changes. Note:

Save the customised report comments

It is essential to save the report customisation to a settings file (refer to your Uromac User’s Manual, and the section on Saving the Setup). These changes will need to be implemented and saved in each settings file you use. UroReport v3.1.9 User Manual

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2.2

Patient Demographics

Fig.4. The Patient Demographics entry window.

You can now enter the patient's information into the fields shown. Any keyboard characters or numbers can be used in any of the fields, however it is preferrable not to enter more text than can be viewed in the boxes provided. Additional text will be stored but may not be printed on the final report. The following formats for your entries are suggested but not required. These formats will allow data to be exported to other programs in a meaningful and standardised way. Patient name Patient ID Sex Age Height Weight Referring Dr

as "Surname Firstname" your ID or UR number format "Male" or "Female" - Don’t type, select the option. in years in cm's. ie: "186 cm" in kg's. ie: "67 kg" as "Firstname Surname"

Note that if you have previously named the file using the main file menu, that name will automatically appear in the patient name field. This field can be edited by simply deleting the Patient Name field and entering your own data. When all the patient demographic information has been entered, press Report to step to the next data entry page (Fig. 4). Alternatively you can use one of the top eight buttons to step between consecutive pages.

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2.3

Report Details

Fig.5. The Report Details entry page.

Enter the required information into each field either by free text or by using the previously customised ‘menu selection lists’. The Hospital/Institution and Department fields can be changed as required, but will default to the last values entered when the settings file is saved. If different departments share the same system, they can save individual Uromac settings files containing the correct information. Press the Today button to insert today's date automatically. Alternatively, the date can be manually entered in any desired format. You must select which relevant graphs/nomograms of void data you require to be printed in the final report, by checking the relevant check boxes at the bottom of the window. Note that at the time of publication the check box for ‘Print User Warnings’performed no function.

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2.4

Fill Phase

Fig.6. The Fill Phase data entry page.

The Fill Phase is used to analyse the waveform data collected while the bladder is filling. It is recommended that at least the filling medium, method and rate are nominated. These three parameters will retain default values when the report settings are saved (Refer to section 6 : "Saving the Setup"). Filling medium

The solution used to fill the bladder. Set menu: "Water", "Saline" or "Other". If "Other" is selected the user may enter free-form text.

Method

The method of transferring this solution to the bladder. Set menu: "Gravitational", "Pumped" or "Other". If "Other" is selected the user may enter free-form text.

Rate

The rate at which the bladder is filled in units of ml/min. Set menu: "Calculated","25,50,75,100 ml/min" or "Other" If "Calculated" is selected the rate is calculated from the actual change in Vfill and time raw data. If "Other" is selected the user may enter a numeric value.

Event Comment

Use the check list and Include/Exclude buttons to build the events required to be listed in the final patient report. Note: If an event comment key is not used during the patient filling phase and that comment has been incuded on the transfer list, a small floating window will appear on screen during auto analysis, requesting the user to either enter that point (by double clicking at that point, if known, on the waveform display) or ignoring it by clicking the ‘skip’ button in that floating window. See the section Report creation and data transfer for more details.

Referral Statements

Urge incontinence/ Stress incontinence/ Instability. Click on the button appropriate for the current patient.

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2.5

Void Phase

Fig.7. Select Report Setup from the Patient menu.

Analysis of the Voiding phase requires no additional user information, only the transfer of a set of data points. See the section titled Data Transfer for more details. Event Comment

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Use the check list and Include/Exclude buttons to build the events required by your testing protocol. Usually all of these events are required.

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2.6

Urethral Pressure Profile

Fig.8. Select Report Setup from the Patient menu.

There are two Urethral phases available, the Empty and Full phases, for testing with an empty and full bladder. These two phases have identical data windows so are discussed here together. The Profilometer Speed is required to be entered in order to calculate the urethral length. The Urethral Infusion Rate is relevant only to perfused lumen fluid filled catheter use and is not used in calculations. The infusion rate selected will be printed on the report. Values entered for these parameters will be retained as default values when the report setup is saved. (Refer to section “Saving the Setup”). If the values are different for the current test, select as required. They will not be saved as defaults. Urethral infusion rate

Numeric value required (ml/min.) Set menu: "1, 5 10 ml/min" or "To match the infusion speed used in your testing protocol usually it is 5ml/min". If "Other" is selected, enter the rate used.

Profilometer speed

Numeric value required (mm/sec.) Set menu: ‘0.2, 0.5, 1.0, 2.0, 3.0 mm/sec’ or "To match the withdrawal speed selected on the withdrawal unit". If "Other" is selected, enter the speed used.

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2.7

Video Micturating Cystogram

Fig.9. Select Report Setup from the Patient Report menu.

This window is used to record observations from the optional AcquiVideo radiography image display or other Urodynamic video sources. All entries are freeform text but again care should be taken not to type more characters than can be viewed in the box provided. Additional characters will be stored but may not be printed on the final report. If no observations are recorded the Video Micturating Cystogram section of the final report will be omitted rather than showing blank fields. Note:

To use text/statements already stored in your customised ‘Menu Selection List’ press the Set menu and select from the menu. (Refer to section “Customising Comments”)

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2.8

Summary Comments

Fig.10. Select Report Setup from the Patient Report menu.

The summary comments window gives you the opportunity to enter extended text comments of up to 255 characters or about 9 lines per box. Some commonly used comments are available for insertion from the set menus. These comments are formatted and printed at the bottom of the patient report. These comments are optional and if no comment is entered, the relevant section of the report is omitted, rather than showing empty fields. Once you have entered information into a field, toggle between the comment fields by selecting the radio buttons for each. Upon completion press Update Report to ensure the report is refreshed with the new comments/changes. Note:

To use text/statements already stored in your customised ‘Menu Selection List’ press the Set menu icon and select from the menu. (Refer to section “Customising Comments”)

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3.

REPORT CREATION AND DATA TRANSFER

3.1

Analysing your data:

To assist in the explanation of how to analyse your report data we have classified comments as either a) Measurement Events, such as ‘max Pdet rise’ which can be determined from the physiological recording, and b) Patient Events, such as ‘Urgency’ which record the state of the patient which could not be determined from the patient record. Recommendations for data analysis in UroReport: If your recorded patient data is good quality and the data contains little artefact or physiologically ambiguous data, the fully automated software analysis will give good results. Otherwise a combination of manual and automated (or even fully manual) analysis may be more appropriate. In either case, we recommend that the user inspects the patient record and the final report before accepting the report’s results. If you have doubts about the reliability of the software’s analysis, you may prefer to make manual selections of the Measurement Events. In this instance (as a worst case) the number of manual measurements (each requiring a double mouse click on the correct point on the waveform) would be: Fill Phase (2 points) Void Phase (5 points) Urethral Phase (7 points) From someone familiar with a urodynamics recording this takes under 15 seconds for both Fill and Void phase, and less than 15 seconds for the Urethral phase. Adopting this protocol will ensure the most reliable report generation. DURING ACQUISITION OF THE PATIENT RECORD: Insertion of Patient Event Comments: Patient event comments should be entered into the patient record during the patient recording at the appropriate time. The user may choose the predefined (ICS) patient event comments from the keyboard template using the function ('F') keys. These include 'First Desire to Void', 'Normal Desire' or 'Urgency', during the filling cystometrogram phase or 'Told to Void' in the voiding phase. Free text event comments using the keyboard and the 'return' key can also be inserted. Measurement event comments are not entered during patient data acquisition. Whilst recording we do not recommend stopping acquisition in the middle of a phase as this could result in time related errors in some calculations (see the appendix on Troubleshooting). AFTER ACQUISITION OF THE PATIENT RECORD: Analysis of the data and event comments: Select (highlight) the waveform area across the area of the waveform (ie. the phase) you wish to analyse. Ensure the selection includes at least a couple of seconds of resting (baseline) data before and after the event, such as flow or vesical filling volume. Select ‘Analyse’ from the Patient Report menu (or the Toolbar). This operation will insert a comment at the beginning and end of that selection (ie. ‘Begin Fill Selection’ and ‘End Fill Selection’, or ‘Begin Void Selection’ and ‘End Void Selection’) , these are indicators for the software to know the bounds of the phase selection you have chosen. Reviewing the waveform display you will see new vertical dotted lines and the associated comment boxes under the points on the waveforms. These are the comments that the software has selected for the analysis. Check that you agree with the position of the measurement points in the record. If not, you can remove and replace each of UroReport v3.1.9 User Manual

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the comments in a selected phase by reviewing the points sequentially in the manual analysis mini-window as described in the next section. Removing and re-entering Event comments: If a measurement point in the phase selection is not in the correct position, use the manual entry mini-window to clear and re-enter it. The miniwindow will appear after the data is analysed or if ‘Analyse’ is clicked with no data selected. Use Prev and Skip to move between comments and Clear to delete a comment. For a detailed description of the use of the mini-window refer to the section below “Checking the data points transferred”. When viewing the mini-windows, note that where a solid dot precedes each Event this indicates that the value has already been transferred (ie. detected or measured). The transferred data is also indicated in the patient record by a flashing bar beneath the comment box (at the base of the waveform data). If you make any changes to the comments it is necessary to re-analyse the phase prior to displaying the report, or none of the changes will take effect. Again, highlight the area encompassing the phase event comments (including any new comments), then select ‘Analyse’ from the ‘Patient Report’ menu (or the toolbar). Placing Event comments manually: Event comments can be inserted manually to assist the software in finding events. It may be more efficient not to rely on the software to find an event if you already know where it is, particularly if the patient waveform data contains recording artefact (making software detection more difficult). It is particularly useful to mark the start and end of each phase (fill and void) and the start and end of each pressure or flow event, or measurement reference points such as Pdet rise. Event comments are inserted by either 1) clicking on the waveform at the point of measurement value to leave a blinking cursor marker, and then pressing the relevant predefined function ('F') key on the keyboard, or 2) by using the manual entry miniwindow (refer to the section “Checking the data points transferred”). Select the desired phase and step through the options, inserting the points which can be identified one by one. Preview and Print the Report Select Preview Report from the Patient Report menu and check the report results. If necessary close the report, open the Report Setup menu and enter phase comments, or other options. Close, and preview the report again. Once complete, whilst the report is being previewed, select Print Report from the File menu. Close all windows and save your data. Report Messages: Note that during analysis and when previewing reports messages will occasionally appear to prompt the user for additional information, or to inform the user of problems with the analysis. The most common messages are described in appendix C. Summary: To analyse the patient record: Step 1: Insert Patient Event comments during acquisition using the function (F) keys. Step 2: Insert Measurement Event comments from the keyboard template, or select ANALYSE and then insert, or clear, Event comments as necessary via the manual analysis miniwindow. Step 3: Highlight the phase to be analysed. Step 4: Select ‘Analyse’. Step 5: Review the comments using the miniwindow, or ‘Preview’ the report results. Step 6: Whilst previewing the report, select Print Report from the File menu. Repeat steps 2 to 5 if necessary, until you are satisfied with the results. UroReport v3.1.9 User Manual

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3.2 Note:

More on automatic analysis Automatic analysis is only available on the Filling and Voiding Phases. Analysis of the Urethral phases must be performed manually by the user.

If a selection of the waveform is highlighted and analysed the UroReport software will attempt to find and analyse data based on the criteria described in the appendix “Internal Calculations”. It is suggested that the user insert all Patient Events using the select/F-Key operation (see the section “Analysing your data” above), select the area and analyse. The phase will be offered and results found. A mini-window will appear to offer the option of inserting points not found. If the auto transfer encounters a problem such as the desired comments not being in the correct place, or that the phase data may be questionable, then UroReport will inform you and give you the option to transfer any phase data points manually. At this point you must select points on the waveforms corresponding to the points in each phase as displayed in the manual Transfer data entry window shown in Fig.14. You will be prompted for all the points you had Include‘ed in each phase of the Report Setup (see section 2.) and discussed in ‘Data Points Transferred’ below. 3.2

More on manual analysis

The second method of transferring data is to manually highlight the waveform for each phase you wish to transfer and then to simply click the ‘Analyse’ button on the toolbar (shown in figure 11). The software will detect if this is an appropriate phase and will also prompt the user to confirm the particular phase and to complete the transfer of data points above.

Fig 11. : Toolbar Buttons (Left Button : To open the Report Setup Window, Right Button : To Analyse the Selected Waveform, or to open the Manual entry Window).

3.3

Checking the data points transferred

As you will have already seen, each phase's window has a list of data points on the right hand side. These lists indicate points in the phase which must be identified in order to calculate all the parameters presented in the report. For studies that do not require (or record) all points, the list can be edited using the Include and Exclude buttons to add or remove points that are not desired. These selections can be made permanent by saving the Uromac setup. Fig 12 explains the various notations shown for points in the transfer list of each phase.

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Point already transferred Not included for transfer Selected but not transferred

Fig.12. Transfer tools

When the desired points have been selected for transfer, press the Transfer button at the bottom of the UroReport Window. The main report window will disappear and a smaller data transfer window will appear over the top of the chart waveform window. Depending on whether Transfer was pressed from within a test phase, or after a transfer phase has been selected the window will appear as in one of the following two figures. If you see the Transfer Phase Selection window, simply press the button corresponding to the phase you wish to transfer, or you can highlight the section of the waveform you wish to Analyse and then simply click on the appropriate button to go to the next phase, or simply hit Report to return to the report setup window.

Fig.13. Transfer phase selection window.

Fig.14. Transfer data entry window.

If the Transfer Data Entry window is visible, you are ready to transfer data for the specified points manually. To transfer a point, simply locate the place on the waveforms corresponding to the specified point and the double-click the mouse on the desired point on the waveform. The menu bar will flash and the Transfer Window will

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advance to the next required point (for details on scrolling over the waveforms see the Uromac Users Manual). To return to a previous point on the list, press Prev. To skip over a point without having to double-click it, press Skip. To remove a double-clicked point from the report, press Clear. To obtain a short description of the current point, pressing Info.

Fig.15. Information for a specific point.

All the selected data points for each tested phase should be transferred before a report is printed. Points which are not transferred will not be included in the report and all calculations based on these points will also be omitted.

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4.

SAVING A REPORT

The contents of the Report are automatically saved along with the waveform data when Save is selected from the File menu. For security, after generating a report you will not be able to quit Uromac application without saving the data. Note that you should correctly quit Uromac before turning off the system power, as the loss of power to the computer before saving a report will result in loss of all unsaved data. A file name must be given to each new file/patient. We recommend using the patient name as entered in the Patient Demographics window, followed by the date. ie: "DOE Jane 21/2/94" (the date is used to allow repeated tests or repeated report generation on the same patient from the ‘File Open’ menu). The operator must also choose where to save their data files. We recommend saving the patient files inside the Uromac Folder called "Patient Files". If all data is stored in this folder, the operator can use View by Name or by Date from the Finder to sort and search for patient data. See the section on "Archiving Your Data" for details on backing-up patient files from your hard disk drive to other permanent storage such as floppy disks. Note:

In previous versions of UroReport, the user has to create a “Patient Folder” inside NMS Uromac V3.x.x folder.

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5.

SAVING THE SETUP

If you edit setup items in the report and wish these changes to be set as default, you must save the setup, by creating a settings file. When a setup is saved it includes not only defaults for the UroReport, but also the calibration values and the setup details of the Uromac file. Be sure that everything is as required before saving the settings file. The recommended way of changing the settings is to launch Uromac, open a new, untitled file, make only the changes that you require and then immediately save the setup as a settings file into the calibration folder. Saving the Setup as a Settings file 1. 2. 3. 4. 5.

Open an untitled file Make all the desired changes to the untitled file, including items such as scrolling speed, transducer calibration factors, compression ratio and UroReport settings. When you have completed making all the changes required, go to the Save Menu under the File Menu and select it. An option window will appear as shown in Fig. 16. Select ‘Settings File’ from the File Format window as shown below and then enter a descriptive file name for the settings file. You have now completed the settings file. To launch using this as the default settings file, double click on the required settings file in the calibration folder and the computer will launch Uromac.

Fig 16. Save window under the File Menu

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