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Page 2 of 100 Chapter 1. LICENSE / WARRANTY NOTICE TO USERS OF THE LUMAX TS PRO FIBEROPTIC CYSTOMETRY SYSTEM PRODUCT DESCRIPTIONS NOT INTENDED FOR DIAGNOSTIC PURPOSES. The descriptions and narratives in this User Manual and other written materials provided to Licensee with this Lumax TS Pro Fiberoptic Cystometry System ‘Product’ are intended to provide a foundation for use of the Product along with host computer and software. Actual printout images and any depictions of these images in the User Manual and accompanying written materials are not intended for diagnostic purposes. CHANGES IN SPECIFICATIONS FOR PRODUCT. All specifications for the Product are subject to change without notice. CooperSurgical Inc., Trumbull CT, 06611 USA. Contents of this User Manual and other written materials provided to Licensee with the Product may not be reproduced by any means whatsoever without prior written permission from CooperSurgical, Inc. All products mentioned in this User Manual and related written materials are trademarked or copyrighted by their manufacturers. All CooperSurgical, Inc., Products are covered by U.S. and other patents and/or patents pending. All product names are trademarks of CooperSurgical, Inc. All trademarks and the rights of the trademarks owned by the companies referred to in this User Manual and other written materials provided to Licensee with the Product are acknowledged. WARRANTY FOR PRODUCT The Product manufactured by CooperSurgical, Inc., is warranted against defects in material and workmanship for twelve (12) months from date of installation. During the warranty period, CooperSurgical, Inc., will repair or replace (at its option) a Product proven to be defective. Warranty repairs may be performed on site, at the factory, or at a CooperSurgical, Inc., approved service center without charge, provided the Product was not subjected to misuse, theft, neglect, fire, Acts of God, lightning strikes, or deterioration caused by chemicals that are not used for normal unit operation. Any modifications of the Product in any manner, including but not limited to relocation or installation of the Product without prior CooperSurgical, Inc., Customer Service authorization, shall void all associated warranties or service contracts. Prior to prepaid return of products for repair, the Product must have a Return Authorization Number (obtainable from CooperSurgical, Inc., Customer Service) attached to it. BEYOND THE WARRANTIES STATED ABOVE, THERE ARE NO OTHER WARRANTIES OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY (INCLUDING, WITHOUT LIMITATION, TIMELINESS, TRUTHFULNESS, SEQUENCE, COMPLETENESS, ACCURACY, FREEDOM FROM INTERRUPTION), ANY IMPLIED WARRANTIES ARISING FROM TRADE USAGE, COURSE OF DEALING, OR COURSE OF PERFORMANCE, OR THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. LICENSEE’S EXCLUSIVE REMEDY FOR BREACH OF WARRANTY OR BREACH OF CONTRACT, NEGLIGENCE OR PRODUCTS LIABILITY SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE OR DAMAGED GOODS.
Page 3 of 100 Table of Contents CHAPTER 1. LICENSE / WARRANTY ...... 3 CHAPTER 2. INTENDED USE / INDICATIONS ...... 9 2.1 CONTRAINDICATIONS ...... 9
2.2 WARNINGS ...... 9
2.3 PRECAUTIONS ...... 9 CHAPTER 3. INTRODUCTION ...... 10 CHAPTER 4. SETUP ...... 11 4.1 LAUNCHING LUMAX INSTALL ...... 11
4.2 INSTALLATION STEPS ...... 13
4.3 CONNECTING YOUR HARDWARE ...... 20 CHAPTER 5. INITIAL STARTUP ...... 24 5.1 CONTEXT/FONTS ...... 25
5.2 TERMINOLOGY ...... 25
5.3 MANUAL CONTEXT ...... 25 CHAPTER 6. INITIAL DISPLAY ...... 26 CHAPTER 7. SELECT PATIENT ...... 27 7.1 HIDE PATIENT DATA ...... 28
7.2 LAST NAME ...... 29
7.3 PATIENT ID ...... 29
7.4 VISIT DATE ...... 30
7.5 NEW PATIENT ...... 31
7.6 EXIT APPLICATION...... 31 CHAPTER 8. PATIENT INFORMATION ...... 32 8.1 LAST NAME ...... 32
8.2 FIRST NAME ...... 32
8.3 MIDDLE INITIAL ...... 32
8.4 ADDRESS ...... 32
8.5 PHONE NUMBER ...... 33
8.6 PATIENT ID ...... 33
8.7 DATE OF BIRTH ...... 33
8.8 AGE ...... 33
8.9 WEIGHT ...... 33
8.10 SELECT RACE ...... 33
8.11 SELECT GENDER - FEMALE ...... 33
8.12 GRAVIDA ...... 33
8.13 PARIDA ...... 33
8.14 SELECT GENDER - MALE ...... 34
8.15 PSA SCORE ...... 34
8.16 TOTAL I-PSS ...... 34
Page 4 of 100 8.17 SELECT PRIMARY PHYSICIAN ...... 35 8.18 SELECT REFERRING PHYSICIAN ...... 35 8.19 SELECT VISIT ...... 35 8.20 HIDE PATIENT DATA / SHOW PATIENT DATA ...... 35 8.21 NEW PATIENT ...... 36 8.22 SAVE ...... 36 8.23 CANCEL ...... 36 8.24 SEND PATIENT INFO TO MONITOR ...... 36 8.25 EXIT APPLICATION...... 36 8.26 ADD/EDIT RACE ...... 37 8.27 ADD/EDIT PRIMARY PHYSICIAN ...... 38 8.28 ADD/EDIT REFERRING PHYSICIAN ...... 39 8.29 ADD/EDIT USER ...... 40 CHAPTER 9. STUDIES ...... 41 9.1 PATIENT NAME ...... 41 9.2 VISIT ...... 41 9.3 STUDY ...... 41 9.4 HIDE PATIENT DATA / SHOW PATIENT DATA ...... 42 9.5 SHOW SUMMARY / HIDE SUMMARY ...... 42 9.6 PRESSURE SCALE 100/200 ...... 43 9.7 FLOW SCALE 25/50 ...... 43 9.8 CALCULATE LPP ...... 43 9.9 CALCULATE UCP ...... 43 9.10 SAVE ZOOMED STUDY ...... 44 9.11 PRINT ALL STUDIES ...... 45 9.12 PRINT THIS STUDY ...... 45 9.13 EXPORT ALL STUDIES ...... 46 9.14 EXPORT THIS STUDY ...... 46 9.15 EDIT EVENTS ...... 46 CHAPTER 10. UROFLOW STUDY (FLOW STUDY) ...... 47 10.1 UROFLOW SUMMARY ...... 48 10.1.1 Voided Volume ...... 48 10.1.2 Voiding Time ...... 48 10.1.3 Flow Time ...... 48 10.1.4 Hesitancy ...... 48 10.1.5 Qura Max ...... 48 10.1.6 Qura Avg ...... 48 10.1.7 Time to Qura Max ...... 48 CHAPTER 11. 3-CHANNEL CMG (COMPLEX CYSTOMETROGRAM, FILLING STUDY, CYSTOMETRY) ...... 49 11.1 CMG SUMMARY ...... 50 11.1.1 Infused Volume ...... 50 Page 5 of 100 11.1.2 Average Rate Infused ...... 50 11.1.3 Calculate LPP ...... 50 11.1.4 Include In Report ...... 50 11.1.5 Auto Calculated LPP ...... 51 CHAPTER 12. URETHRAL PRESSURE PROFILE (UPP) ...... 52 12.1 URETHRAL PRESSURE PROFILE SUMMARY ...... 52 12.1.1 Calculate UCP ...... 53 12.1.2 Include In Report ...... 53 12.1.3 Auto Calculated UCP ...... 53 CHAPTER 13. 3 CHANNEL CMG WITH UROFLOW ...... 54 13.1 3-CHANNEL CMG WITH UROFLOW SUMMARY ...... 54 13.1.1 Infused Volume ...... 55 13.1.2 Average Rate Infused ...... 55 13.1.3 Voided Volume ...... 55 13.1.4 Voiding Time ...... 55 13.1.5 Flow Time ...... 55 13.1.6 Qura Max ...... 55 13.1.7 Qura Avg ...... 55 13.1.8 Time to Qura Max ...... 55 13.1.9 Pdet at Qura Max ...... 55 13.1.10 Pdet Max ...... 55 CHAPTER 14. EMG STUDY ...... 56 14.1 EMG SUMMARY ...... 57 14.1.1 Max Microvolts ...... 57 CHAPTER 15. 4-CHANNEL CMG (COMPLEX CYSTOMETROGRAM, FILLING STUDY, CYSTOMETRY WITH EMG) ...... 58 15.1 4 CHANNEL CMG SUMMARY ...... 59 15.1.1 Infused Volume ...... 59 15.1.2 Average Rate Infused ...... 59 15.1.3 Max Microvolts ...... 59 15.1.4 Calculate LPP ...... 59 15.1.5 Include In Report ...... 60 15.1.6 Auto Calculated LPP ...... 60 CHAPTER 16. 4 CHANNEL CMG WITH UROFLOW ...... 61 16.1 4-CHANNEL CMG WITH UROFLOW SUMMARY ...... 62 16.1.1 Infused Volume ...... 62 16.1.2 Average Rate Infused ...... 62 16.1.3 Voided Volume ...... 62 16.1.4 Voiding Time ...... 62 16.1.5 Flow Time ...... 62 16.1.6 Qura Max ...... 62 16.1.7 Qura Avg ...... 63
Page 6 of 100 16.1.8 Time to Qura Max ...... 63 16.1.9 Pdet at Qura Max ...... 63 16.1.10 Pdet Max ...... 63 16.1.11 Max Microvolts ...... 63 CHAPTER 17. VISITS ...... 64 17.1 PATIENT INFORMATION ...... 64 17.1.1 Patient Name ...... 64 17.1.2 Patient ID ...... 64 17.1.3 Patient Date of Birth ...... 64 17.2 SELECT INVESTIGATOR ...... 65 17.3 BLADDER CATHETER USED...... 65 17.4 SELECT VISIT ...... 65 17.5 LPP DATA VALUES ...... 65 17.6 UCP DATA VALUES ...... 65 17.7 HIDE PATIENT DATA / SHOW PATIENT DATA ...... 65 17.8 ADD / EDIT INVESTIGATOR ...... 66 17.9 EDIT QUICK TEXT ...... 66 17.10 SELECT REPORTS TO PRINT ...... 67 17.10.1 Patient Report ...... 67 17.10.2 Referral Report ...... 67 17.10.3 Chart Report ...... 67 17.10.4 All Studies ...... 67 17.11 PRINT REPORT ...... 67 17.12 EXPORT REPORT ...... 68 CHAPTER 18. POPULATING REPORT DATA ...... 69 18.1 REPORT SECTIONS ...... 69 18.1.1 ICD-9-CM...... 69 18.1.2 Patient’s Medications ...... 69 18.1.3 Anatomical Defects ...... 69 18.1.4 Medications Discontinued for Tests...... 70 18.1.5 Symptoms and Complaints ...... 70 18.1.6 Urodynamic Findings...... 70 18.1.7 Post Test Actions ...... 70 18.1.8 Recommendations ...... 70 18.2 EXAMPLE OF VISITS SCREEN FULLY POPULATED ...... 70 CHAPTER 19. YOUR FIRST STUDY ...... 71 19.1 ADDING A NEW PATIENT ...... 71 19.2 SELECTING AN EXISTING PATIENT ...... 73 19.3 SENDING PATIENT INFO TO THE LUMAX MONITOR ...... 74 19.4 CALIBRATING CATHETERS ...... 75 19.5 SELECTING A STUDY/PROTOCOL ...... 76 Page 7 of 100 19.6 BEGINNING A STUDY ...... 77 19.7 PAUSING A STUDY ...... 78 19.8 ENDING A STUDY ...... 78 19.9 STUDY SUMMARY ...... 79 19.10 STUDY COMPLETED DURING A PROTOCOL ...... 81 19.10.1 Perform Next Study ...... 81 19.10.2 Repeat Study ...... 81 19.10.3 Skip Next Study ...... 81 19.10.4 Patient Visit Complete ...... 81 19.11 STUDY COMPLETED DURING A SINGLE STUDY ...... 81 19.11.1 Repeat Study ...... 82 19.11.2 Continue Patient Visit ...... 82 19.11.3 Patient Visit Complete ...... 82 CHAPTER 20. ADVANCED STUDY EDITING ...... 83 20.1 EDIT EVENTS ...... 83 20.1.1 Add Event ...... 84 20.1.2 Delete Event ...... 86 20.1.3 Edit Event ...... 87 20.1.4 Exit Edit Mode ...... 89 CHAPTER 21. ADVANCED QUICK TEXT EDITING ...... 90 21.1 OVERVIEW ...... 90 21.2 NAVIGATION ...... 91 21.3 ADD ...... 91 21.4 SAVE ...... 91 21.5 DELETE ...... 92 21.6 CLOSE ...... 92 CHAPTER 22. LUMAX BACKUP ...... 93 CHAPTER 23. UPDATING LUMAX SOFTWARE ...... 94 CHAPTER 24. TROUBLE SHOOTING GUIDE ...... 98
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Chapter 2. INTENDED USE / INDICATIONS
The Lumax™ TS Pro Fiberoptic Cystometry System is used for the diagnosis of urinary incontinence, voiding dysfunction and other bladder disorders. The Lumax™ Fiberoptic Catheters are intended to measure physiologic pressures during urodynamic studies and, to infuse fluid into the bladder and drain fluid from the bladder. 2.1 Contraindications Do Not Use this product if the patient exhibits infection or any other heightened sensitivity. 2.2 Warnings DANGER: Equipment not suitable for use in the presence of flammable anesthetics. 2.3 Precautions Caution: To insure ground reliability, attach cord to receptacle marked “Hospital Grade” or equivalent only. Caution: Electric shock hazard. Do not remove covers. Refer Servicing to qualified Service Personnel. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Precaution: Operate the Lumax™ TS Pro Fiberoptic Cystometry System only at 100-240 V AC at 50/60 Hz. Precaution: Do not get fluid into monitor. Should any liquid or solid object fall into the module case, unplug the unit and call CooperSurgical Technical Support at 1-800-444-8456. Precaution: Unplug the unit from the wall outlet if it is not going to be used for several days. To disconnect the cord, pull it out by the plug. Never pull the cord itself. Precaution: Never lean or place weighted objects on top of unit. Precaution: Do not immerse uroflow transducers in water or cleaning fluids. Uroflow transducer is cleanable (water resistant) and may be rinsed under a faucet. Do not immerse unit under water as this can damage components. Precaution: Do not immerse volume transducers in water or cleaning fluids. Volume transducer may be cleaned by wiping with a slightly damp cloth using mild household detergent. Precaution: Do not use strong solvent such as acetone, thinner, or benzene as they might damage the finish of the monitor. Clean the monitor with a slightly damp cloth. Use a mild household detergent. Precaution: Retain the original carton and packing materials for safe transport of this unit in the future. Precaution: Do not install unit in a hot or humid place subject to excessive dust or mechanical vibration. Operate only at 10oC (50oF) to 40oC (100oF); 30% to 75% relative humidity (non-condensing). Precaution: Used catheters should be considered a biological hazard and should be disposed of according to policy. Precaution: Do not attach monitor higher than 5 feet from the floor to ensure proper balancing of the module on the IV pole. Precaution: Avoid severe bending or stretching of the fiberoptic catheters. Such use may cause permanent damage to optical components or compromise performance. Precaution: Avoid bumping or moving the connector once the catheter is attached to the receptacle. This action may interfere with accuracy of pressure readings.
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Chapter 3. INTRODUCTION
The Lumax TS Pro Advanced software is an upgrade option designed to run with the Lumax TS Pro Basic system. This software was designed to add more documentation features and benefits to the Lumax TS Pro system. With the optional Lumax TS Pro Advanced software, you can retain patient information, study data and reports indefinitely. This information can be backed up to a DVD-ROM to ensure the integrity of your data. The Lumax TS Pro Advanced software allows the user to customize quick text, which are placeholders for commonly used terms when creating: a) chart report, b) referral letter and c) patient letters. In addition, you can use regular 8.5 x 11 sized paper to print out copies of patient studies when the laptop is connected to a printer. The Lumax TS Pro Advanced software can be used with any standard Windows XP USB compatible printers. The Lumax TS Pro Advanced software documents all visits for patients. The user can also quickly compare data between visit dates. Warning: Do not connect the Lumax unit via the USB Cable to the laptop until the Lumax TS Pro Advanced software has been installed.
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Chapter 4. SETUP
The Lumax TS Pro Advanced software comes with its own installation CD. The installation CD should be kept in a safe place. In addition, the software can be operated while not connected to a Lumax TS Pro Monitor however, live study data will not be transmitted. This feature is important, as the user can pre-enter patient information before a patient visit. When the patient arrives, the user can simply select the patient from the database and begin a study immediately. The system also allows for user edits for up to 90 days after the patient visit is ended. Note: After 90 days a patient’s visit is locked, and you CAN NOT edit their data. 4.1 Launching Lumax Install Installing your new Lumax TS Pro Advanced software is very easy. Simply insert the CD into your CD-Drive and the software installation begins. If it does not automatically start follow these instructions: Click on the Start button on your task bar as shown in Figure 1.
Figure 1 - Windows Start Menu
When you click on the Start Menu, the menu will expand and look similar to that shown in Figure 2.
My Computer
Figure 2 - Start Menu
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Click on My Computer, as shown in Figure 2. A new window will open, which will show you the Hard Drives as well as CD Drives / Removable Storage devices as shown in Figure 3. Double click on the DVD/CD-RW Drive.
Figure 3 - My Computer
You will see a set of files similar to the following shown in Figure 4, Double click on the setup.exe file, and this will initiate the setup process.
Figure 4 - CD Contents
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4.2 Installation Steps Once the Lumax installation program is running, you can follow the steps to ensure proper setup. The first dialog to appear is captured in Figure 5.
Figure 5 - Initial Installation Dialog
The next dialog is the Welcome dialog, which provides some basic information regarding the installation. A snapshot is shown in Figure 6.
Figure 6 - Welcome Dialog
You may click the Cancel button at any time to abort the installation. Click Next to continue.
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Figure 7 - License Agreement
The License Agreement is a contractual agreement between the owner and CooperSurgical. Please read it carefully then select “I accept the terms of the license agreement”. Select Next to continue.
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Figure 8 - Customer Information
Next you will enter user information. This is only for purposes of the installation and will not be carried over to the actual software. Generally, you would put in your primary Doctors name, followed by the name of the clinic or practice. Select Next to continue.
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Figure 9 - Ready to Install
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The installation program is ready to begin copying files to the computer hard drive. Select Install to continue. When doing so, you will see files copying to the hard drive as illustrated in Figure 10.
Figure 10 - Setup Status
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Next the installation will launch the Microsoft .NET 2.0 Framework as shown in Figure 11. Please note that this installation takes approximately 5-7 minutes to complete.
Figure 11 - Microsoft .NET 2.0 Framework
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Next the installation will launch the Adobe Acrobat Reader 8.0 installation as shown in Figure 12.
Figure 12 - Adobe Acrobat Reader 8.0
Once the Adobe Reader is finished being installed, the Installation Completion dialog will be displayed as shown in Figure 13.
Figure 13 – Re start My Computer
The system will instruct you to reboot your computer. Select Yes to reboot your system. Select the Finish button to restart your system. After rebooting, the software is enabled.
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4.3 Connecting Your Hardware Before running Lumax for the first time, you must insert your HASP key, which is required to operate the Lumax TS Pro Advanced software. The system will detect the presence of the HASP key and will install the necessary drivers. The HASP key will light up, once it is ready for operation. As shown in Figure 14 the HASP Key is placed above the USB cable.
HASP Key in USB Port
Figure 14 - HASP Key Connection
In order for the Lumax TS Pro Advanced software to communicate with the Lumax Monitor, you must also follow these instructions. A USB cable is supplied along with the accompanying laptop. Plug one end of the USB cable into the back of the Lumax TS Pro unit and the other into the laptop. Connect the Flat end of the USB cable into the USB port on the back of the laptop as shown in Figure 15.
USB Cable
Figure 15 - USB Cable to Laptop
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The other (more squared end) of the USB cable will plug directly into the back of the Lumax unit as shown in Figure 16.
USB Cable
Figure 16 - USB Cable to Lumax
Once installation and connection are complete, the system is ready for use. When you connect the USB cable and turn on the Lumax TS Pro, after a minute or so, the dialog shown in Figure 17 will appear.
Figure 17 - Found New Hardware Wizard
Select the Next button and allow the Wizard to locate the driver automatically.
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Windows will begin searching for the device, and a dialog similar to the one shown in Figure 18 will be displayed.
Figure 18 - Searching for Driver
You may receive a warning, indicating that “the driver has not been tested by Microsoft® therefore it may not be compatible.” Select the Continue Anyway button as shown in Figure 19.
Figure 19 - Hardware Installation Warning
When you select Continue Anyway, the system will initiate driver installation.
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A dialog similar to the following shown in Figure 20 will be displayed during the file copy process.
Figure 20 - Installing Driver Files
Once the system has installed the driver, a finished dialog will appear as shown in Figure 21.
Figure 21 - Hardware Wizard Completed
Select Finish and proceed to Initial startup.
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Chapter 5. INITIAL STARTUP
Turn the Lumax TS Pro monitor power ON. A tone will indicate active communication. When Lumax TS Pro Advanced is first launched you will be required to log in to the system.
Figure 22 - Lumax Login Dialog
The default user name is admin and the default password is admin. After entering the username and password click OK. There is an indicator on the Lumax TS Pro Advanced Main Screen which displays the current connection state as shown in Figure 23. Figure 23 shows the connectivity state as Not Connected.
Not Connected
Figure 23 - Lumax TS Pro Advanced (Not Connected)
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If the Lumax TS Pro Advanced software is connected, then it will display as shown in Figure 24.
Connection Active
Figure 24 - Lumax TS Pro Advanced (Connection Active)
5.1 Context/Fonts On the Patient Information screen there are four (4) fields that have their titles in bold font. The bold font indicates that these are required fields. You cannot save New Patient data without these data fields. In addition, a valid date of birth needs to be entered as well. When the New Patient button is selected, the Date of Birth field will default to the current date. Once a patient file is saved and if the Lumax TS Pro unit is requesting the Patient Information, you will then be able to transmit that information to the monitor. This process will be covered in detail in Section 8.24 Send Patient Info To Monitor. 5.2 Terminology Some basic terminology is used throughout this manual. These include the following: User – the clinician performing the tests or working with the software. Patient – the person who is being tested or who’s information is being documented in the software. Study – Relates to urodynamic studies such as Uroflow, 3 Channel CMG, Urethral Pressure Profile or a 3 Channel CMG with Uroflow. Visit – a visit is considered to be all studies and/or patient information documented in a single session. For example: A Patient with studies on Monday only is considered a single visit. If the same patient returns for additional studies on Friday, then that is considered another Visit regardless of the number of studies performed, it is the date that defines a visit. 5.3 Manual Context This manual is divided into several sections. The first section will cover each screen that is visible to the user. The second section will walk the user through a visit, which will include studies performed with the Lumax TS Pro. The final section will cover all of the reporting features and additional options that the user can utilize with the Lumax TS Pro Advanced software.
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Chapter 6. INITIAL DISPLAY
When the Lumax TS Pro Advanced software is first started, there will be two tabs visible to the user. These tabs are: Select Patient and Patient Information. Once a patient has been selected, two additional tabs will appear which are: Studies and Visits. Unless a patient is selected you cannot review their studies or their visit related information. To select a particular tab such as Patient Information click on its title bar with the mouse as seen in Figure 25.
Figure 25 - Initial Display with Patient Information Screen showing
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Chapter 7. SELECT PATIENT
The Select Patient screen is used to select an existing patient. In addition, you can also select the New Patient button, which will take you to the Patient Information screen. There are three methods of searching, which will help you find a patient quickly. First, let’s take a look at the Select Patient screen as it is shown in Figure 26 below.
Hide Patient Data
Figure 26 - Select Patient Screen with Patient Data Shown
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7.1 Hide Patient Data There is one button which is common to all four (4) screens, and that is the Hide Patient Data button. This is for patient confidentiality. Shown in Figure 27 is the Select Patient screen with the patient information hidden. As you can see, the button Hide Patient Data now displays Show Patient Data.
Show Patient Data
Figure 27 - Select Patient Screen with Patient Data Hidden
On the Select Patient screen, there are several data entry fields that are explained in the following sections:
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7.2 Last Name From this field, you can enter a patient’s last name. As you begin to type, the Patient List automatically begins showing patients whose last name begins with (the typed alphabetical character). For example, in the image shown in Figure 28 the user entered “be”, in this case, all of the patient’s last names beginning with “be” are visible.
Figure 28 - Last Name Filtering
7.3 Patient ID The Patient ID field allows the user to enter in a patient’s ID. This is very useful, as a quick search feature if you have a lot of patients with similar names. You can navigate quickly to the particular patient you are searching for by using this field. For example, we will filter the patient’s ID by simply entering a “01”, when this is done all of the other patients who’s ID does not start with a “01” will be filtered out as shown in Figure 29.
Figure 29 - Patient ID Filtering
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7.4 Visit Date From this field, you can filter out visits that did not occur on the specific date specified in the Visit Date control. Our two patients visited our office on the same day, therefore, both patients are visible in the patient list as shown in Figure 30.
Figure 30 - Visit Date Filtering
To see all patients or clear any existing parameters in the Search for Patient controls, select the Clear Search button.
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When this is done all patients become visible in the list, as shown in Figure 31. In addition, the Visit Date field defaults back to the current date.
Figure 31 - All Filtering Off
When the patient you are looking for is located and you click on that patient in the patient listing, it will automatically display the Patient Information screen with that patient’s data. 7.5 New Patient The New Patient button allows the user to create a new patient file. Upon selection it will automatically navigate the user to the Patient Information screen where data can be entered. The Patient Information screen is discussed in the next section. 7.6 Exit Application The Exit Application button is found on several screens. This function will allow the user to exit the Lumax TS Pro Advanced software.
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Chapter 8. PATIENT INFORMATION
The Patient Information screen allows the user to add or edit patient information. The four primary fields of the patient information screen; Last Name, First Name, Date of Birth, and Patient ID are highlighted in bold and are required data fields. These fields must be filled in before you can save the Patient to the database. Figure 32 is an example of the Patient Information screen with some fields populated with data.
Figure 32 - Patient Information Screen – Female
Each of the Patient Information Screen Fields are described in detail in the following sections. 8.1 Last Name The Last Name field is for data entry of the patient’s last name. It is a required field for the patient information screen. 8.2 First Name The First Name field is for data entry of the patient’s first name. It is a required field for the patient information screen. 8.3 Middle Initial The Middle Initial field is for data entry of the patient’s middle initial. This is not a required field. 8.4 Address The Address field is for data entry of the patient’s mailing address. This field is not a required field for the Patient Information screen. However, it is required when printing out the patient letter following a visit. If this field is not populated when entering the patient data then when you attempt to generate the patient letter it will warn the user that the patient’s address is blank. At that point the system will give the user an opportunity to fill in the address.
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8.5 Phone Number The Phone Number field represents the patient’s phone number. 8.6 Patient ID The Patient ID field is for data entry of the patient’s ID; each practice has their own method of assigning identification codes to a patient. The method and format is up to the user. The patient ID is a required field for the patient information screen. Note: All patient ID’s must be unique. They are not case sensitive so that AbC, ABC, abC and abc are all the same. When assigning a patient ID, be sure to use a unique value. Any letter, symbol or number from the keyboard may be used. Typically, many practices use a patient’s social security number. The system will not allow you to save patient information with a non-unique patient ID. This rule will help differentiate patients with the same name. 8.7 Date of Birth The Date of Birth field is for data entry of the patient’s date of birth. This is a required field on the patient information screen. 8.8 Age The Age field is for data entry of the patient’s age. This field is note editable, and is automatically calculated based on the Date of Birth field and the current date. 8.9 Weight The Weight field represents the patient’s weight; it can be in kilograms or pounds and can be individualized to the practice’s preference to select the method they plan to use. 8.10 Select Race The Select Race drop down list box contains many of the more commonly used races. However, the user can add additional races should they not be covered in the default list. The default list cannot be modified. 8.11 Select Gender - Female The Gender drop down list box is for data entry of the sex of the patient. It defaults to Female when selecting New Patient. Note: The following two definitions are defined in US terminology. 8.12 Gravida The Gravida field presents the number of times a woman has been pregnant. 8.13 Parida The Parida field represents the number of times a woman has given birth to a fetus with a gestational age of 24 weeks or more, regardless of whether the child was born alive or was stillborn. Example: A woman who is described as “gravida 1, parida 2” has had one pregnancy which resulted in twins and a woman who is described as “gravida 2, parida 0” has had two pregnancies, neither of which survived to a gestational age of 24 weeks.
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Figure 33 - Patient Information Screen – Male
8.14 Select Gender - Male The Gender drop down list box is for data entry of the sex of the patient. It defaults to Female when selecting New Patient, however you may select Male Note: The following two definitions are defined in US terminology. 8.15 PSA Score Prostate specific antigen (PSA) is a glycoprotein that is expressed by prostate tissue. PSA levels may be elevated in men with prostate cancer because PSA production is increased and because tissue barriers between the prostate gland lumen and the capillary are disrupted, releasing more PSA into the serum. The absolute value of serum PSA is useful for determining the extent of prostate cancer and assessing the response to prostate cancer treatment; its use as a screening method to detect prostate cancer is also common. A number of assays are available to measure serum PSA; a concentration above 4 ng/mL is considered abnormal in most. The PSA concentration increases yearly in men over the age of 40; it increases at a faster rate in elderly men. As a result, different normal reference ranges may be appropriate based upon a man's age. Studies in the early 1990s confirmed that serum total PSA could be used to identify men with prostate cancer. Studies have estimated that PSA elevations can precede clinical disease by 5 to 10 years or even longer. Although the majority of prostate cancers express PSA, between 20% and 50% of men with prostate cancers have serum PSA values below 4.0 ng/mL. PSA is also elevated in a number of benign conditions particularly benign prostatic hyperplasia (BPH) and prostatitis. 8.16 Total I-PSS Benign prostatic hyperplasia (BPH) becomes increasingly common as men age. BPH can lead to urinary symptoms that may benefit from medical or surgical treatment. However, many men with BPH are asymptomatic or have only mild symptoms and may not require therapy. The common symptoms of BPH are increased frequency of urination, nocturia, hesitancy, urgency, and weak urinary stream. These symptoms typically appear slowly and progress gradually over a period of years. In general, these symptoms only require therapy if they have a significant impact on a patient's quality of life. The decision to treat is usually based on the severity of symptoms and the patient's tolerance for these symptoms. Use of the International Prostate Symptom Score (IPSS) permits quantitation of symptom severity and monitoring of symptom progression over time.
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8.17 Select Primary Physician The Select Primary Physician drop down list box is for data entry of the primary physician name, typically this would be the physician who is currently managing the patient’s workup. You will need to use the Add/Edit Primary Physician button to add the primary physician of your practice. The primary physician name is linked to the referral letters. 8.18 Select Referring Physician The Select Referring Physician drop down list box is for data entry of the referring physician name; typically this would be the physician who has referred a patient to your practice to perform the testing. You will need to use the Add/Edit Referring Physician button to add referring physicians. 8.19 Select Visit The Select Visit drop down list box contains all the patient’s visits. A visit is not a visit until at least one study is performed on a patient. This drop down list is automatically updated each time a new visit takes place. In addition to the various fields on this screen there are also several buttons that perform different tasks, which are listed below. 8.20 Hide Patient Data / Show Patient Data The Hide Patient Data / Show Patient Data button has been described in the previous section. When hiding the patient data on the Patient Information screen, the screen will typically look like that in Figure 34.
Figure 34 - Patient Information Screen with Hidden Patient Data
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8.21 New Patient The New Patient button will clear out any populated fields on the screen and will enable all of the appropriate fields for data entry. Pictured in Figure 35 is an image of the Patient Information screen as seen when it first appears.
Figure 35 - New Patient
All of the fields except the Date of Birth field are blank; the Date of Birth field automatically defaults to the current date. Note: As a reminder the Last Name, First Name, Patient ID and a valid Date of Birth must be entered before you can press the Save button. 8.22 Save The Save button becomes enabled only if data has been changed since it was last saved. When entering a new patient the Save button becomes enabled immediately after you modify any of the fields. 8.23 Cancel The Cancel button becomes enabled only if data has been changed since it was last saved. If the cancel button is selected then any changes made since the last save are discarded. 8.24 Send Patient Info to Monitor The Send Patient Info to Monitor button is only enabled when the Lumax TS Pro Monitor is requesting patient information from the Lumax TS Pro Advanced software and a patient file has been created. If the Lumax TS Pro Monitor is waiting for patient data and you do not already have the patient selected or created, you can create a new patient and enter in the minimum mandatory fields, or switch to the select patient screen and select an existing patient. 8.25 Exit Application The Exit Application button exits the user from the Lumax TS Pro Advanced software.
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8.26 Add/Edit Race The Add/Edit Race button creates a new dialog, which allows the user to create a race file to be used within the Lumax TS Pro Advanced software. If you press the Add/Edit Race button, the following dialog is displayed.
Figure 36 - Add / Edit Race Dialog
When you select the Add New button, you may enter a race, then select Save. If you change your mind, you may select Cancel and the new race will not be added. Finally, once you have added any additional races you need, you may press the Close button to close the Add/Edit Race dialog.
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8.27 Add/Edit Primary Physician The Add/Edit Primary Physician button creates a new dialog, which allows you to add primary physicians and their addresses. Note: The system prevents duplicate entries, in other words you cannot have 2 Dr. Chopra’s, even if he has two different office locations and therefore, as shown below in the example, we associated a location with the name. An example of the Add/Edit Primary Physician dialog is shown in Figure 37.
Figure 37 - Add / Edit Primary Physician
Selecting Add New button allows the user to enter an additional primary physician. Select Save to set the entry. If you change your mind you may select Cancel and the new physician entry will not be added. Select the Close button to close the Add/Edit Primary Physician dialog.
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8.28 Add/Edit Referring Physician The Add/Edit Referring Physician button creates a new dialog, which allows you to add referring physicians and their addresses. Note: The system prevents duplicate entries, in other words you cannot have 2 Dr. Smith’s, even if he has two different office locations and therefore, as shown below in the example, we associated a location with the name. An example of the Add/Edit Referring Physician dialog is shown in Figure 38.
Figure 38 - Add / Edit Referring Physician
Selecting the Add New button will facilitate entering an additional referring physician. Select Save to set the data. Select Cancel and the new physician will not be added. Select the Close button to close the Add/Edit Referring Physician dialog. Note: The referring physician’s address must be populated when printing the Referral Letter. If you attempt to print a referral letter without a referring physicians address, the system will prompt you to enter the address and then print the letter.
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8.29 Add/Edit User The Add/Edit User button creates a new dialog, which allows you to add users and their passwords. An example of the Add/Edit User dialog is shown in Figure 39.
Figure 39 - Add / Edit User Accounts
Selecting the Add New button will facilitate entering an additional user. Select Save to set the data. Select Cancel and the new user will not be added. Select the Close button to close the Add/Edit User dialog.
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Chapter 9. STUDIES
The Studies screen allows the user to review previously saved studies. Studies are not available until after the first patient visit is concluded. At that point you can review, edit, annotate and print the study. In this section any of the urodynamic studies can be reviewed by the user. Pictured in Figure 40 is a Uroflow (Flow) study.
Patient Name
Figure 40 - General Study Screen
The following sections describe the common fields located in all study screens. 9.1 Patient Name The Patient Name label displays the current patient’s name. 9.2 Visit The Visit drop down list box is populated with all the visits for a patient. By selecting a visit date the studies specific to that visit date are populated in the study drop down list box. 9.3 Study The Study drop down list box contains all of the studies for the visit specified in the Visit drop down list box.
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9.4 Hide Patient Data / Show Patient Data The Hide Patient Data / Show Patient Data button has been described in the previous section. When hiding the patient data on the Studies screen, the screen will typically look like that in Figure 41.
Figure 41 - Study Screen with Hide Patient Data Enabled 9.5 Show Summary / Hide Summary The Show Summary / Hide Summary button is used to toggle the study summary information on and off. Pictured in Figure 42 is the study screen with the summary data visible. Note that the title of the button changes to Hide Summary.
Figure 42 - Summary Data Displayed
Each study has different study summary data, which is detailed in the next section.
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9.6 Pressure Scale 100/200 The Pressure Scale 100/200 button allows the user to change the scaling of the graph on the horizontal axis between100 and 200. This only applies to studies that utilize the Pves channel or Pabd channel. 9.7 Flow Scale 25/50 The Flow Scale 25/50 button allows the user to change the scaling of the graph on the horizontal axis between 25 and 50. This only applies to studies that utilize the Uroflow transducer. Figure 43, shows the graph scaled to 25 instead of 50 as shown in Figure 42.
Figure 43 - Uroflow Graph Scaled to 25
9.8 Calculate LPP The Calculate LPP button is used to calculate the Leak Point Pressure, which is only available with a 3 Channel CMG study. LPP is calculated by following the instructions that appear after selecting the Calculate LPP button. A hand icon will appear when the user has placed the cursor over a data point and this indicates that a calculation can be generated. 9.9 Calculate UCP The Calculate UCP button is used to calculate the Maximum Urethral Closure Pressure (MUCP), which is only available in a Urethral Pressure Profile study. MUCP is calculated by following the instructions that appear after selecting the Calculate UCP button. A hand icon will appear when the user has placed the cursor over a data point and this indicates that a calculation can be generated.
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9.10 Save Zoomed Study The Save Zoomed Study function allows the user to save a zoomed study for quick retrieval. The study may be long in length, and rather than seeing the entire study compressed, a section of the study has been zoomed for review, and then saved for quick viewing. When a part of a study is zoomed (by holding the left mouse button down and dragging the mouse to the left or right) that section is zoomed as shown in Figure 44. When the section is zoomed, the Save Zoomed Study button becomes enabled.
Figure 44 - Section Zoomed
When the user presses the Save Zoomed Study button, a dialog is presented, which allows the user to modify the default Study Title, and assign it an appropriate or descriptive name as shown in Figure 45.
Figure 45 - Save Zoomed Study Name
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When the user presses the Save Study button, a copy of the zoomed study is saved and can be retrieved by selecting it from the Study drop down list as shown in Figure 46.
Figure 46 - Selecting a Saved Zoom Study 9.11 Print All Studies The Print All Studies button is used to print a copy of all studies performed. It includes the study header, including patient information as well as the study summary data for each study. 9.12 Print This Study The Print This Study button is used to print a copy of the currently visible study. It also prints a study header, including patient information as well as the study summary data. When you select the Print This Study button, a typical Windows dialog is displayed, as shown in Figure 47. With this dialog you can print and/or change the printer functions.
Figure 47 - Windows Print Dialog
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9.13 Export All Studies The Export All Studies button is used to export a copy of all studies performed to PDF format. It includes the study header, including patient information as well as the study summary data for each study. 9.14 Export This Study The Export This Study button is used to export a copy of the currently visible study. It also exports a study header, including patient information as well as the study summary data. When you select the Export This Study button, a dialog is displayed, as shown in Figure 48. With this dialog you can specify where you want to export your study to.
Figure 48 - Select Export Folders Here you may select to browse for each location to export. Letters can be exported to one location while Studies may be exported to another location. 9.15 Edit Events The Edit Events button allows the user to add additional events following a live study. This function is useful for post study documentation and analysis. This will be described in the Advanced Section of this manual.
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Chapter 10. UROFLOW STUDY (FLOW STUDY)
Description: measures the urine flow rate visually, electronically or with the use of a disposable unit. The flow rate reflects the combined activity of the detrusor muscle, bladder neck, and urethral function. Decreased flow rate may be due to poor detrusor function from, for example, neurologic lesions, obstructing benign prostatic hypertrophy (BPH), or cystocele. Increased flow rate may indicate poor urethral function causing, for example, stress urinary incontinence (SUI) or intrinsic sphincter dysfunction (ISD). Pictured in Figure 49 is a Uroflow study.
Figure 49 - Uroflow Study Screen
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10.1 Uroflow Summary The Show Summary button on the Uroflow study, displays the summary data collected during the study. The summary information for a Uroflow study is shown in Figure 50.
Figure 50 - Uroflow Study with Summary 10.1.1 Voided Volume The Voided Volume value represents the total amount of fluid that was voided during the study.
10.1.2 Voiding Time The Voiding Time value represents the difference in time from when voiding began, until the study was completed. This includes any and all interruptions during the study.
10.1.3 Flow Time The Flow Time value represents the voiding time, but excludes interruptions. In other words, this value only represents the physical amount of time when liquid was actually flowing to the Uroflow transducer.
10.1.4 Hesitancy The Hesitancy value indicates the difference in time from when the study actually began, to when fluid began flowing to the Uroflow transducer.
10.1.5 Qura Max The Qura Max value represents the highest amount of liquid voided during the study.
10.1.6 Qura Avg The Qura Avg value is calculated by dividing the amount of liquid voided by the flow time. This is considered to be the average.
10.1.7 Time to Qura Max The Time to Qura Max value indicates the amount of physical time it took to reach Qura Max.
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Chapter 11. 3-CHANNEL CMG (Complex Cystometrogram, Filling Study, Cystometry)
Description: is used to evaluate detrusor contractions and abnormalities of bladder compliance, to measure post-voiding residual, to determine bladder capacity and to detect DSD (detrusor sphincter dyssynergia). Abnormal results are expected with stress incontinence. Complex cystometrogram involves the use of calibrated electronic equipment to measure intra-abdominal, total bladder, and true detrusor pressures simultaneously. Its purpose is to differentiate an involuntary detrusor contraction or reversed bladder compliance from an increase in intra-abdominal pressure. False positives may be a problem, especially in the elderly. Pictured in Figure 51 is a 3-Channel CMG study.
Figure 51 - 3 Channel CMG Study Screen
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11.1 CMG Summary The Show Summary button on the 3 Channel CMG study, displays the summary data collected during the study. The summary information for a 3 Channel CMG is shown in Figure 52.
Figure 52 - 3 Channel CMG Study with Summary 11.1.1 Infused Volume The Infused Volume value represents the total value of sterile saline infused into the patient in milliliters.
11.1.2 Average Rate Infused The Average Rate Infused value represents the average rate in which infusion took place.
11.1.3 Calculate LPP The Calculate LPP (Leak Point Pressure) button is used to compute the leak point pressure, based on subtracting the resting Pves pressure from the documented leak point. Select the Calculate LPP button and follow the instructions, which will ask the user to point and click the mouse pointer over the resting pressure and the leak point. A hand icon will appear when the user has placed the cursor over a data point and this indicates that a calculation can be generated. The computer will calculate the LPP and store it in the database. The ml value is the infused volume at the point in which the LPP was calculated. There are three boxes which contain LPP values. The system will store up to three different leak points. If you add a fourth leak point, the first leak point saved will be overwritten.
11.1.4 Include In Report The Include in Report check boxes under each calculated LPP entry are for the user to decide if he/she wants them included in the final reporting. If they are not checked they will not be printed on the report.
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11.1.5 Auto Calculated LPP A new feature added to the system is its ability to auto-calculate Leak Point Pressure during a 3-Channel CMG study. To perform an auto-calculation of Leak Point Pressure the user presses the Generic EVENT marker on the Lumax Monitor or the Handheld Remote to mark the baseline pressure on the PVES channel prior to the evocative patient maneuver. If, on this maneuver a leak is observed by the clinician, they would subsequently press the LEAK event marker on the Lumax Monitor or the Handheld Remote to mark the leak on the PVES channel. The auto-calculated LPP will be calculated as (LPP = LEAK – EVENT). Auto Calculated Leak Point Pressures will not automatically be transferred to the reports. The user will have to verify the values and check the check box below its associated leak point values to Include on Report.
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Chapter 12. URETHRAL PRESSURE PROFILE (UPP)
Description: measure resting and dynamic pressures along the length of the urethra responsible for maintaining continence. Urethral pressure studies are used to rule out severe urethral incompetence (ISD). Pictured in Figure 53 is a Urethral Pressure Profile study.
Figure 53 - Urethral Pressure Profile Study Screen
12.1 Urethral Pressure Profile Summary The Show Summary button on the UPP study, displays the MUCP values, as there is no other summary data for a UPP study to show. You can view the calculated MUCP by clicking on the show summary button as shown in Figure 54.
Figure 54 - UPP Study with Summary
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12.1.1 Calculate UCP The Calculate UCP button is used to calculate the Urethral Closure Pressure. When you select the Calculate UCP button, the system advises you to click on the Pves baseline with the mouse pointer. A hand icon will appear when the user has placed the cursor over a data point and this indicates that a calculation can be generated. The second value it will ask you for is the Maximum Urethral Closure Pressure (MUCP). The cmH20 value is the difference between the Pves baseline and the MUCP. There are three boxes which contain UCP values. The system will store up to three different urethral closure points. If you add a fourth urethral closure point, the first urethral closure point saved will be overwritten.
12.1.2 Include In Report The Include in Report check boxes under each calculated LPP entry are for the user to decide if he/she wants them included in the final reporting. If they are not checked they will not be printed on the report.
12.1.3 Auto Calculated UCP A new feature added to the system is its ability to auto-calculate Urethral Closure Pressure during a Urethral Pressure Profile study. To perform an auto-calculation of Urethral Closure Pressure the user presses the Generic EVENT marker on the Lumax Monitor or the Handheld Remote to establish the baseline pressure on the PVES channel. The auto-calculated UCP will be calculated as (UCP = MAX PURA VALUE - EVENT). Auto Calculated Urethral Closure Pressure values will not automatically be transferred to the reports. The user will have to verify the values and check the check box below its associated urethral closure pressure values to Include on Report.
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Chapter 13. 3 CHANNEL CMG WITH UROFLOW
Description: can measure detrusor contractility and detect outlet pressure obstruction if the patient is able to void. Simultaneous measurement of detrusor and urethral pressures during voiding is especially helpful in diagnosing urodynamic obstruction. Pictured in Figure 55 is a 3-Channel CMG with Uroflow (Flow) study.
Figure 55 – 3-Channel CMG with Uroflow Study Screen
13.1 3-Channel CMG with Uroflow Summary The Show Summary button on the 3-Channel CMG with Uroflow study, displays the summary data collected during the study. The summary information for a 3 Channel CMG with Uroflow is shown in Figure 56.
Figure 56 – 3-Channel CMG with Uroflow Study Summary
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13.1.1 Infused Volume The Infused Volume value represents the total value of saline infused into the patient in milliliters.
13.1.2 Average Rate Infused The Average Rate Infused value represents the average rate in which infusion took place.
13.1.3 Voided Volume The Voided Volume value represents the total amount of fluid that was voided during the study.
13.1.4 Voiding Time The Voiding Time value represents the difference in time from when voiding began, until the study was completed. This includes any and all interruptions during the study.
13.1.5 Flow Time The Flow Time value represents the voiding time, but excludes interruptions. In other words, this value only represents the physical amount of time when liquid was actually flowing to the Uroflow transducer.
13.1.6 Qura Max The Qura Max value represents the highest amount of liquid voided during the study.
13.1.7 Qura Avg The Qura Avg value is calculated by dividing the amount of liquid voided by the flow time. This is considered to be the average.
13.1.8 Time to Qura Max The Time to Qura Max value indicates the amount of physical time it took to reach Qura Max.
13.1.9 Pdet at Qura Max The Pdet at Qura Max value indicates the Pdet pressure when Qura Max was detected.
13.1.10 Pdet Max The Pdet Max value indicates the max Pdet pressure detected during the entire study.
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Chapter 14. EMG STUDY
Description: EMG techniques study neuromuscular activity of striated muscles, using a recording electrode that is placed on the surface of a muscle. Bioelectric potentials generated by the depolarization of the skeletal striated muscle are picked up by the electrode and then filtered and amplified and then displayed on a graph. EMG testing is used to assess the activity or inactivity during a defined activity. EMG is most frequently used during voiding studies to detect detrusor sphincter dyssynergia in which a detrusor contraction is coupled with a simultaneous sphincter contraction, resulting in abnormal voiding and frequent urinary retention. Pictured in Figure 57 is an EMG study.
Figure 57 - EMG Study Screen
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14.1 EMG Summary The Show Summary button on the EMG study, displays the summary data collected during the study. The summary information for a EMG study is shown in Figure 58.
Figure 58 - EMG Study with Summary
14.1.1 Max Microvolts The Max Microvolts value represents the maximum micro voltage measured during the study.
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Chapter 15. 4-CHANNEL CMG (Complex Cystometrogram, Filling Study, Cystometry with EMG)
Description: The CMG and EMG studies, when combined, provide a 4-channel analysis of the filling and storage and muscular activity of the pelvic floor and bladder. Refer to Section Chapter 14 for EMG definition and Section Chapter 11 for CMG definition. Pictured in Figure 59 is a 4-Channel CMG study.
Figure 59 - 4 Channel CMG Study Screen
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15.1 4 Channel CMG Summary The Show Summary button on the 4 Channel CMG study, displays the summary data collected during the study. The summary information for a 4 Channel CMG is shown in Figure 60.
Figure 60 - 4 Channel CMG Study with Summary
15.1.1 Infused Volume The Infused Volume value represents the total value of sterile saline infused into the patient in milliliters.
15.1.2 Average Rate Infused The Average Rate Infused value represents the average rate in which infusion took place.
15.1.3 Max Microvolts The Max Microvolts value represents the maximum micro voltage measured during the study.
15.1.4 Calculate LPP The Calculate LPP (Leak Point Pressure) button is used to compute the leak point pressure, based on subtracting the resting Pves pressure from the documented leak point. Select the Calculate LPP button and follow the instructions, which will ask the user to point and click the mouse pointer over the resting pressure and the leak point. A hand icon will appear when the user has placed the cursor over a data point and this indicates that a calculation can be generated. The computer will calculate the LPP and store it in the database. The ml value is the infused volume at the point in which the LPP was calculated. There are three boxes which contain LPP values. The system will store up to three different leak points. If you add a fourth leak point, the first leak point saved will be overwritten.
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15.1.5 Include In Report The Include in Report check boxes under each calculated LPP entry are for the user to decide if he/she wants them included in the final reporting. If they are not checked they will not be printed on the report.
15.1.6 Auto Calculated LPP A new feature added to the system is its ability to auto-calculate Leak Point Pressure during a 4-Channel CMG study. To perform an auto-calculation of Leak Point Pressure the user presses the Generic EVENT marker on the Lumax Monitor or the Handheld Remote to mark the baseline pressure on the PVES channel prior to the evocative patient maneuver. If, on this maneuver a leak is observed by the clinician, they would subsequently press the LEAK event marker on the Lumax Monitor or the Handheld Remote to mark the leak on the PVES channel. The auto-calculated LPP will be calculated as (LPP = LEAK – EVENT). Auto Calculated Leak Point Pressures will not automatically be transferred to the reports. The user will have to verify the values and check the check box below its associated leak point values to Include on Report.
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Chapter 16. 4 CHANNEL CMG WITH UROFLOW
Description: The Pressure Flow with EMG study provides data on the voiding mechanism and neuromuscular coordination of the pelvic floor and bladder. Refer to Section Chapter 13 for 3-Channel CMG with Uroflow definition and Section Chapter 14 for EMG definition. Pictured in Figure 61 is a 4-Channel CMG with Uroflow (Flow) study.
Figure 61 – 4-Channel CMG with Uroflow Study Screen
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16.1 4-Channel CMG with Uroflow Summary The Show Summary button on the 4-Channel CMG with Uroflow study, displays the summary data collected during the study. The summary information for a 4 Channel CMG with Uroflow is shown in Figure 62.
Figure 62 – 4-Channel CMG with Uroflow Study Summary
16.1.1 Infused Volume The Infused Volume value represents the total value of saline infused into the patient in milliliters.
16.1.2 Average Rate Infused The Average Rate Infused value represents the average rate in which infusion took place.
16.1.3 Voided Volume The Voided Volume value represents the total amount of fluid that was voided during the study.
16.1.4 Voiding Time The Voiding Time value represents the difference in time from when voiding began, until the study was completed. This includes any and all interruptions during the study.
16.1.5 Flow Time The Flow Time value represents the voiding time, but excludes interruptions. In other words, this value only represents the physical amount of time when liquid was actually flowing to the Uroflow transducer.
16.1.6 Qura Max The Qura Max value represents the highest amount of liquid voided during the study.
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16.1.7 Qura Avg The Qura Avg value is calculated by dividing the amount of liquid voided by the flow time. This is considered to be the average.
16.1.8 Time to Qura Max The Time to Qura Max value indicates the amount of physical time it took to reach Qura Max.
16.1.9 Pdet at Qura Max The Pdet at Qura Max value indicates the Pdet pressure when Qura Max was detected.
16.1.10 Pdet Max The Pdet Max value indicates the max Pdet pressure detected during the entire study.
16.1.11 Max Microvolts The Max Microvolts value represents the maximum micro voltage measured during the study.
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Chapter 17. VISITS
The Visits screen allows the user to create a more complete urodynamic patient record for a patient’s particular visit. It allows the user to create a Patient Summary Report, a Referral Letter as well as a Patient Letter. The Visits screen is pictured in Figure 63. Many of the data fields are pre-populated with standardized urodynamic/patient history text that can be changed by the user. Each category in the left pane has corresponding shortcuts in the right pane, which make creating a report much easier and saves the user time as they need not manually type in basic urodynamic terminology. The user may edit the various “Quick Text” fields, which is described later in the Advanced Quick Text Editing section.
Figure 63 - Visit Screen
17.1 Patient Information At the top of the Visit screen is the basic patient information that was inputted in the Select Patient screen. This is useful in identifying the patient when using this screen.
17.1.1 Patient Name The Patient Name is shown in bold face font.
17.1.2 Patient ID The Patient ID is also shown.
17.1.3 Patient Date of Birth The Patient’s Date of Birth is also visible.
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17.2 Select Investigator The Select Investigator drop down list box allows the user to select the investigator for this visit. An investigator is typically the clinical person who actually performed the study, and is NOT the physician who will be evaluating the results. Clicking on the drop down list box, will allow you to select the investigator for this particular visit. 17.3 Bladder Catheter Used The Bladder Catheter Used drop down list box contains only two options: 10 French or 7 French and is specific to the bladder catheter only. All abdominal catheters are 10 French and therefore not listed or of much clinical significance. 17.4 Select Visit The Select Visit drop down list box allows you to select another visit should you wish to quickly review a patient’s last visit or any other visit on record for this patient. The information found on this screen is visit dependent except for the Patient ID and most likely their Date of Birth as well. This allows you to reprint the various reports from other visits in case the user chooses to do a side-by-side comparison of the results. 17.5 LPP Data Values The LPP Data Values are present on the Visit screen, but are only applicable if the visit contains a 3-Channel CMG Study. It would contain the same values found on the 3-Channel CMG study summary. 17.6 UCP Data Values The UCP Data Values are present on the Visit screen, but are only applicable if the visit contains a Urethral Pressure Profile study and the UCP was calculated. It would contain the same values found on the Urethral Pressure Profile study summary. 17.7 Hide Patient Data / Show Patient Data The Hide Patient Data / Show Patient Data button has been described in previous sections. When hiding the patient data on the Visit screen, the screen will typically look like that in Figure 64.
Figure 64 - Hide Patient Data on Visit Screen
As with all of the other screens, the Hide Patient Data buttons caption changes to Show Patient Data.
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17.8 Add / Edit Investigator The Add / Edit Investigator button is used to add a new investigator or edit an existing investigator. When you press the Add / Edit Investigator button, the following dialog is displayed, as shown in Figure 65.
Figure 65 - Add / Edit Investigator Dialog
When you select the Add New button, you may enter a new Investigator, then select Save. If you change your mind you may select Cancel and the new investigator will not be added. Once you have added any additional investigators you may select the Close button to close the Add/Edit Investigator dialog. 17.9 Edit Quick Text The Edit Quick Text button is used to enable the quick text editing feature. This is a key feature of the Lumax TS Pro Advanced software and will be detailed later in this manual. The dialog, which you will use to edit quick text is shown in Figure 66.
Figure 66 - Add / Edit Quick Text Dialog
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17.10 Select Reports to Print A group of check boxes are available on the Visit screen. These boxes are used to select one or more reports to be printed simultaneously when the Print Report button is pressed.
17.10.1 Patient Report The Patient Report selection prints a report (letter) which can be used to send to the patient with the results of their tests.
17.10.2 Referral Report The Referral Report prints a report (letter) which can be sent to the referring physician, which describes in detail the results of their patient’s tests.
17.10.3 Chart Report The Chart Report prints a report which is generally placed in the patient chart.
17.10.4 All Studies The All Studies prints all studies for the visit. 17.11 Print Report The Print Report button initiates the printing of the selected reports. Each report has a set of criteria which must be met such as ensuring that the referring physician is selected and that the referring physician must have an address documented in the data field. The software knows in advance if this information is missing. The system will display a dialog indicating what information is currently missing and will allow the user to make any changes in order to print the report successfully. The following dialog depicts this. All three reports have been selected to print. The first report the system will attempt to print is the patient report. Since we do not have either the Patients address or the Primary Physician set for this visit a warning dialog will ask for this information. The dialog is pictured in Figure 67.
Figure 67 - Could Not Print Patient Report
This type of dialog will appear for each entry that is missing and will prevent the report from being generated. When you press the OK button, you may modify the information required then return to the Visit screen and attempt to generate the report again. After the Patient’s address is filled in and the Primary Physician is selected the system will allow the report to print.
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The standard Windows Print dialog is displayed when the absent data is inputted as shown in Figure 68.
Figure 68 - Windows Print Dialog
17.12 Export Report The Export Report button initiates the exporting of the selected reports to PDF. Each report has a set of criteria which must be met such as ensuring that the referring physician is selected and that the referring physician must have an address documented in the data field. The Export Report dialog is displayed to allow you to select the export locations as shown in Figure 69
Figure 69 - Export Reports
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Chapter 18. POPULATING REPORT DATA
This section describes in detail the various data entry features within the Visits screen. There are two primary panes on this screen as shown in Figure 70. Each of the sections on the left (Report Sections) have accompanying sections on the right (Quick Text Sections), and you can customize each Quick Text entry as described in Section Chapter 21.
Report Sections
Quick Text Data Fields
Figure 70 - Visits Screen - Primary Panes
18.1 Report Sections The Report Sections are the primary sections of the generated reports. There is a list of common header sections which are used to generate most urodynamic reports. Each of them has been listed below. When you select any of these text macros, the text in the right pane is updated with that of corresponding text to fit the Report Sections.
18.1.1 ICD-9-CM The ICD-9-CM section allows the user to specify any ICD-9-CM codes relating to the patient’s diagnosis. As seen in Figure 70, the list to the right contains some basic ICD codes. This data is completely customizable as described in Advanced Quick Text Editing. When you select an item on the right, it is brought over to the section on the left.
18.1.2 Patient’s Medications The Patient’s Medications section allows the user to specify any medications the patient is currently taking. This data is completely customizable as described in Advanced Quick Text Editing.
18.1.3 Anatomical Defects The Anatomical Defects section allows the user to specify any anatomical defects the patient may demonstrate. This data is completely customizable as described in Advanced Quick Text Editing.
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18.1.4 Medications Discontinued for Tests The Medications Discontinued for Tests section allows the user to specify any medications which the patient needed to suspend in preparation for the test procedure. This data is completely customizable as described in Advanced Quick Text Editing.
18.1.5 Symptoms and Complaints The Symptoms and Complaints section allows the user to specify any complaints or symptoms the patient may have. This data is completely customizable as described in Advanced Quick Text Editing.
18.1.6 Urodynamic Findings The Urodynamic Findings section allows the user to specify the urodynamic findings as a result of the testing performed. This data is completely customizable as described in Advanced Quick Text Editing.
18.1.7 Post Test Actions The Post Test Actions section allows the user to specify the actions that were taken following the testing process. This data is completely customizable as described in Advanced Quick Text Editing.
18.1.8 Recommendations The Recommendations section allows the user to specify the recommended actions that should be taken as a result of the testing process. This data is completely customizable as described in Advanced Quick Text Editing. 18.2 Example of Visits Screen Fully Populated Figure 71 is an example of a populated left pane section using various data from the right.
Figure 71 – Visits Screen Fully Populated
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Chapter 19. YOUR FIRST STUDY
To use the Lumax TS Pro Advanced software for the first time you should be somewhat familiar with basic Windows operations as well as the Lumax TS Pro unit. You should also have some basic understanding of Urodynamics. Be sure to read section 4.3 Connecting Your Hardware and have connected all of the USB hardware to your Lumax and your laptop before to proceeding. Depending on how your practice operates you may enter in new patient information prior to the actual patient arriving or you may enter the patient information prior to the study. As indicated earlier, the Last Name, First Name, Patient ID and a valid Date of Birth at a minimum must be entered before you will be able to transmit the information to the Lumax unit and begin performing studies. 19.1 Adding a New Patient If you are starting a new patient we will walk you through the process. If you have already entered the minimal patient information you may skip this step and go on to section 19.2 Selecting An Existing Patient. Select the Patient Information tab as shown in Figure 72.
Patient Information Tab
New Patient Button
Figure 72 - Patient Information Tab
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Select the New Patient button. When you select the New Patient button, the fields on the Patient Information tab will become enabled, allowing you to enter data, as shown in Figure 73.
Save Button
Figure 73 - Patient Information Fields Enabled Be sure to enter the Patient’s Last Name, First Name, Patient ID and Date of Birth at a minimum. Once done, select the Save button. After entering this information and selecting the Save button, your screen should look like that shown in Figure 74.
Figure 74 - Patient Information Entered
You can now go on to section 19.3 Sending Patient Info to Monitor to send the patient information to Lumax.
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19.2 Selecting an Existing Patient If you have already entered the patient information into the system and would like to select the specified patient to perform the study on, then go to the Select Patient tab as shown in Figure 75.
Figure 75 - Select Patient Tab
Once this tab becomes visible, selecting the patient in the patient list will highlight that patient file and bring you back to the patient information screen with this patient’s information. From there you will be able to transmit the patient information to Lumax. Figure 76 shows what happens after you select a patient from the patient list.
Figure 76 - Select Patient - Patient Selected
Now that you have your patient selected you may proceed to Section 19.3 Sending Patient Info to Monitor to send the patient information to the Lumax Monitor to begin the study process.
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19.3 Sending Patient Info to the Lumax Monitor You are now ready to transmit the patient information to The Lumax Monitor. First you must take action on the Lumax unit to enable our ability to transmit this data. Note: in Figure 76 the Send Patient Info to Monitor is grayed out. That is because the Lumax TS Pro Advanced software has not yet received a request for Patient Information. The Lumax Monitor should be at the Main Screen, which is pictured in Figure 77.
Figure 77 - Lumax Main Screen
Note: Your screen will have a different Software Rev number. From this screen, select the New Patient Visit button on the Lumax Monitor. The Lumax Monitor will then display a message that it is waiting for you to transmit the patient information from the laptop to Lumax Monitor. When you select the New Patient Visit button, the Send Patient Info to Monitor button on the laptop will become enabled as shown in Figure 78.
Send Patient Info to Monitor
Figure 78 - Send Patient Info to Monitor
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When you select the Send Patient Info to Monitor, the system will automatically transmit the information to the Lumax Monitor and will be at a blank study screen awaiting data transmission from the Lumax Monitor. The image shown in Figure 79 describes how the laptop software will look like while this is occurring.
Figure 79 - Study Mode - Waiting Transmission
The next steps are all executed on the Lumax Monitor. After sending the patient information to the Lumax Monitor the Lumax Monitor will go to the Calibrate Catheters screen and in anticipation of scanning the catheter barcodes and then calibrating the catheters. After you scan each barcode catheter and press each of the Calibrate buttons, the Lumax unit will look similar to that pictured in Figure 80. 19.4 Calibrating Catheters
Figure 80 - Lumax Monitor after Calibration
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From here, you can Zero the catheters by pressing the Zero button. You will then press the OK button to proceed to the Select Study / Protocol Screen on the Lumax Monitor as shown in Figure 81. 19.5 Selecting a Study/Protocol
Figure 81 - Select Study / Protocol Screen
Note: For this example we have created a custom Test Protocol. If you wish to run a specific study you may do so by selecting a study from the left side of the screen. If you wish to run the Lumax Standard Protocol or your own custom protocol you may select that option instead. Terms: A protocol is a set of studies predefined to be executed in a specific order. In addition, with a protocol you can set VLPP alert messages to appear during CMG studies. A study is a single study and does not allow you to have custom VLPP messages. For this example we will select the Lumax Standard protocol as it is the default for the Lumax TS Pro. The Lumax Standard protocol will introduce studies in the following order: Uroflow, 3-Channel CMG, Urethral Pressure Profile and 3- Channel CMG with Uroflow. Pictured in Figure 82 is a Uroflow Study Screen prior to selecting the Begin button. Select the Begin button when a study is to be initiated. Note the musical note on the Uroflow screen. This indicates the Sound button. By selecting this button the Lumax monitor will play a soothing sound to help aide the patient in relaxing. The soothing sounds will shut off if the Sound button is selected prior to the Begin button. Selecting the Sound button after the Begin button is selected will guarantee sound throughout the study. Note: this feature is only available during the Uroflow study.
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19.6 Beginning a Study
Figure 82 - Uroflow Study Screen
When the user selects Begin, the Lumax Monitor will initiate the study and start the data collection process and the laptop software will also begin displaying the same image. If the user wishes to not Begin a study, they may press the Cancel button, which will return them to the Select Study/Protocol screen as shown in Figure 81. Pictured in Figure 83 and Figure 87 are images of what Lumax and the laptop software will look like during a study. Note: The data in the images is fictitious; they are not exactly the same.
Figure 83 – Lumax Monitor Running a Uroflow Study
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19.7 Pausing a Study Lumax allows the user to Pause a study once it has begun, this is most often used during a CMG study, when the saline bag may run out of fluid. It allows the user to pause the study, replace the saline bag and continue. When the user presses the Pause button during a study, the End button disappears and a Resume button is placed in the location of the Pause button, ensuring that the user Resume the study prior to ending it as shown in Figure 84.
Figure 84 - Study Paused When the Resume button is pressed, the study continues plotting data. During a pause, all live values (e.g., Pves, Pabd, Pdet, EMG) will continue to be displayed on the Lumax monitor as well as the laptop. 19.8 Ending a Study When you have completed your study you may press the End button. This results in the following screen change on Lumax as shown in Figure 85.
Figure 85 - Uroflow Study Completed
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Ending the study provides the user with several options. The user can scroll the graph to the left or right for reviewing purposes. The user can display the summary data and change the graphs scaling and when done reviewing, select the Done button. Selecting the Done button will prompt the user to make a choice of proceeding on to the next study, repeating this study, skipping the next study or ending the patient visit. If you are in a protocol these options are different than they are with executing a single study. Please refer to the Lumax TS Pro Manual for additional information regarding these specifics. 19.9 Study Summary Selecting the Summary button will make the summary data appear as seen in Figure 86.
Figure 86 - Uroflow Study Summary
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Pressing the Close button returns you to the Uroflow Study Completed screen as shown in Figure 85.
Figure 87 - Lumax TS Pro Advanced Running a Uroflow Study
Pictured in Figure 88 shows what the laptop will look like when the Uroflow study has been completed.
Figure 88 - Lumax TS Pro Advanced Uroflow Study Completed
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The laptop system will wait for instructions from the Lumax Monitor. It can either complete the visit or go on and perform another study. Until the Patient Visit Complete button is pressed on the Lumax Monitor, the laptop software will wait for additional studies to be performed. 19.10 Study Completed During a Protocol The study completed options available to the user during a protocol are shown in the next sections. The exception to the rule is when the user completes the last study in the protocol. When this occurs the options available are the same as performing a single study. See Section 19.11 for more information. The picture in Figure 89 shows the options available to the user on the Lumax Monitor if there are more studies within the protocol to be performed.
Figure 89 - Study Completed (In Protocol)
19.10.1 Perform Next Study The Perform Next Study button automatically takes you to the next study in the protocol.
19.10.2 Repeat Study The Repeat Study button repeats the same study you just ran.
19.10.3 Skip Next Study The Skip Next Study button skips the next study in the protocol and proceeds to the following study.
19.10.4 Patient Visit Complete The Patient Visit Complete button instructs Lumax that you have completed testing on this patient, and it saves the study data and returns you to the Main Screen following a second confirmation as shown in Figure 77. 19.11 Study Completed During a Single Study The values available to the user during a single study are also the values displayed during a protocol, following the last study in a protocol.
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The picture in Figure 90 shows the options available to the user on the Lumax Monitor if you just ran the last study in a protocol or, if you selected to perform a single study.
Figure 90 - Study Completed (Single Study)
19.11.1 Repeat Study The Repeat Study button repeats the same study you just ran.
19.11.2 Continue Patient Visit The Continue Patient Visit button allows you to go back to the Select Study / Protocol screen as shown in Figure 81. From there, you can continue to perform studies.
19.11.3 Patient Visit Complete The Patient Visit Complete button instructs Lumax that you have completed testing on this patient, and it saves the study data and returns you to the Main Screen following a second confirmation as shown in Figure 77. CONGRATULATIONS you have successfully performed your first study!
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Chapter 20. ADVANCED STUDY EDITING
The Lumax TS Pro Advanced software allows you to edit study events directly with your mouse. You can Add, Delete and Edit events. In order to enable Event Editing, simply click on the Edit Events button, pictured in Figure 91.
Edit Events
Figure 91 - Edit Events Button
20.1 Edit Events When you select the Edit Events button, the button section of the study screen changes, adding the Add, Delete and Edit buttons as shown in Figure 92.
Figure 92 - Event Editing Mode
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20.1.1 Add Event The Add Event button allows you to add an event to a saved study. When you select the Add Event button the display instructs you to click on the area of the graph in which you wish to add the event as shown in Figure 93. In addition, the Add Event button caption changes to Cancel Add, which will allow you to cancel the addition of the event.
Cancel Add button Click on graph to add event
Figure 93 - Add Event / Cancel Add Button
When you click on the location in which you wish to add the event, a dialog is displayed, which allows you to select the type of event to add. An example of the Add Event dialog is shown in Figure 94.
Figure 94 - Add Event Dialog You select the specific type of event you would like to add, and can optionally add a comment as well. For our example the select a Sensation event and add a comment have been utilized. The dialog will look similar to the one shown in Figure 95.
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Figure 95 - Add Event Dialog with Event / Comment
When the OK button is selected the study graph will change and it will look similar to the following shown in Figure 96.
Our comment and event!
Figure 96 - Added Event to Study
Once the event is added, the Cancel Add button changes back to Add Event!
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20.1.2 Delete Event The Delete Event button is used to delete an event from a saved study. This is useful when a manual edit has been added in the wrong location or the user mistakenly selected an event button during the study. When you press the Delete Event button, the display will instruct the user to click on the area of the graph in which you wish to delete the event as shown in Figure 97. In addition, the Delete Event button caption changes to Cancel Delete, which allows the user to cancel the deletion of an event.
Cancel delete Click on event to delete
Figure 97 - Delete Event / Cancel Delete
When you click on the event you wish to delete, a dialog is displayed, which confirms the event deletion as shown in Figure 98.
Figure 98 - Confirm Delete
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If you click OK, the event will be deleted. If you click Cancel, the event will not be deleted. As seen in Figure 99, the event was deleted and the Cancel Delete button changed its caption back to Delete Event.
Delete Event
Figure 99 - Event Deleted
20.1.3 Edit Event The Edit Event button is used to edit an existing event within a saved study. This is useful in situations where you would like to add a comment to the event type. When the Edit Event button is selected the display instructs the user to click on the event you wish to edit as shown in Figure 100. In addition, the Edit Event buttons caption changes to Cancel Edit, which will allow the user to cancel the editing of an event.
Cancel edit Click on event to edit.
Figure 100 - Edit Event
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When you click on the Event you wish to edit, a dialog is displayed which allows you to add or edit your comments, as shown in Figure 101.
Figure 101 - Edit Event Dialog
In the dialogue “our comment” is changed to, “our sensation”. Select OK to finalize the edit. Once the dialog closes, “our comment” on the graph changes to “our sensation” and the Cancel Edit button reverts back to Edit Event as shown in Figure 102.
Figure 102 - Edited Event
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20.1.4 Exit Edit Mode The Exit Edit Mode button is used to exit the edit mode function and return the user back to the regular graph buttons as shown in Figure 103.
Figure 103 - Exited Edit Mode
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Chapter 21. ADVANCED QUICK TEXT EDITING
The Advanced Quick Text Editing feature of the Lumax TS Pro Advanced laptop software, allows the user to add/enhance commonly used terms or phrases when generating Urodynamic reports. 21.1 Overview As seen in Figure 104 we are using the ICD-9-CM Section and we have added the code “340 – Multiple Sclerosis” as the Quick Text Title. Since we want the description in this case to be the same we will select Add. After selection the user can then enter in the Quick Text title. Selecting Save will copy the title into the description field. This is useful when entering one line text such as a condition or medication.
Save
Add
Figure 104 - Add Edit Quick Text (Simple)
There may be times when you would like to use an acronym or a short phrase which represents a much longer sentence or even a paragraph. In our example in Figure 105, we entered “Intro” as the Quick Text Title. A sentence was added in the Quick Text field and then the Save button was selected and the new values were saved. The text that is in the description field will be added to the report, when you select the Title in the left hand pane of the Visits screen.
Delete Close
Figure 105 - Add / Edit Quick Text (Detailed)
The purpose of the Quick Text feature is to generate some general terms or statements that will be used frequently when generating a report. This feature will make it simpler to generate a report.
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21.2 Navigation The Navigation methods of the Add / Edit Quick Text dialog are relatively straightforward and simple. When you select an item in the Selection column the associated Quick Text titles are displayed in the Quick Text Title column. For example, when we select ICD-9-CM in the Section column, all ICD codes loaded in the software will be displayed in the Quick Text Title column. Conversely, as we select another item in the Section column, the Quick Text Title column will display its associated data. The Quick Text Title / Description defaults to edit mode so that when you select a Section, then select an item in the Quick Text Title column, you will be allowed to edit. When you modify the Quick Text Title or its Description, the Save button will become enabled. This means that it has detected a change. You must press Save to save any edits you have made to the quick text. 21.3 Add The Add button clears out the Quick Text Title and Quick Text Description fields allowing the user to add a new Quick Text title and description. The Section, Anatomical Defects, is shown in Figure 106.
Figure 106 - Add / Edit Quick Text (Add)
With the system in Edit mode the user can select any item in the Quick Text Title column and modify it in the right hand section. Shown is a title of Intro and a description of “On physical examination, a” in the Add/Edit Quick Text window. Editing this field is shown in Figure 107. 21.4 Save The Save button will save any changes made to the Quick Text Title or its Description.
Figure 107 - Add / Edit Quick Text (Edit)
We modified the “On physical examination, a” and added the words “large mass”. Each section of a report can be added with standardized descriptions to create added efficiencies. Notice how the Save button is now enabled? When the Save button is selected the change will be saved and the Save button will become disabled once again.
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21.5 Delete The Delete button allows the user to delete a Quick Text Title and its associated Description. As shown in Figure 108, when the user presses Delete, the system will confirm this action.
Figure 108 - Confirm Quick Text Deletion
If the user selects No the system will return to the prior screen without any further action. If the user selects Yes then the system will delete the current Quick Text Title and its associated Description. In the example shown, the Intro Quick Text Description was deleted and then confirmed by selecting Yes in the confirmation dialog. The resulting screen is seen in Figure 109.
Figure 109 - Add / Edit Quick Text (Delete)
As a result the cystocele item moved to the top of the list and the intro item was removed from the list. 21.6 Close The Close button closes the Add / Edit Quick Text dialog and returns the user back to the Visits screen. If you have recently added or modified an existing item, and select the Close button, the system will prompt you to save your changes as shown in Figure 110.
Figure 110 - Confirm Closure
The Yes button will save your changes, the No button will discard your changes. The Cancel will return the user to the Add / Edit Quick Text dialog.
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Chapter 22. LUMAX BACKUP
This section explains the backup process for Lumax TS Pro Advanced. The Lumax TS Pro Advanced software uses the Windows internal backup process. It will back up your entire “Lumax TS Pro Advanced” directory to your backup DVD. You received two (2) backup DVD’s with your system. One labeled “A” and one “B”. You should alternate these backup discs daily to ensure complete protection. Note: Daily system backup will prevent needless loss of data if the laptop computer has a failure. Following the installation, an icon was placed on the desktop as shown in Figure 111. Double clicking on this icon will start the system backup procedure.
Lumax Backup
Figure 111 - Lumax Backup Icon
Double clicking the Lumax Backup icon will begin the file save process as seen in Figure 112.
Figure 112 - Lumax Backup
Upon completion, the window will close.
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Chapter 23. UPDATING LUMAX SOFTWARE
This section will explain the procedure for updating or upgrading your Lumax TS Pro Advanced software. The purpose of upgrading may be due to enhanced features or product additions and/or changes. To prevent accidental overwriting of any existing data it is important to follow these instructions. Note: Be sure you are not currently running the Lumax TS Pro Advanced software otherwise the installation will not be able to replace any updated files. When you insert an updated CD from CooperSurgical, the system will attempt to automatically execute the Setup program. If it doesn’t, please follow the instructions in Section 4.1 to launch the Setup program. Once it is automatically or manually executed, a different set of dialogs will appear, than when the software was initially installed. The following Modify, Repair or Remove dialog shown in Figure 113 is the first dialog which you will see. Always select the Repair option unless otherwise directed by a CooperSurgical Service Technician. This option will update any out-of- date program files, but will not modify any of your customizations.
Figure 113 - Modify, Repair, Remove
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Select the Next button and the dialog shown in Figure 114 will be displayed while it is updating your files.
Figure 114 - Updating System Files
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When the files are finished copying the following dialog will appear as shown in Figure 115.
Figure 115 - Maintenance Complete
Select the Finish button and the Restart Computer dialog will be displayed as shown in Figure 116. Be sure to restart your system to ensure that all of the files copied are successfully updated on your system.
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Figure 116 - Restart System
Selecting Finish will restart your system.
CONGRATULATIONS your Lumax TS Pro Advanced software has been successfully updated!
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Chapter 24. TROUBLE SHOOTING GUIDE Error Condition Probable Cause Corrective Action
HASP HL Key required to run this HASP Key is not connected Insert HASP key into USB port program is not found.
HASP Key driver not installed Contact Technical Support
HASP HL Key currently does not Insert the appropriate HASP key for support the feature you are Connected the wrong HASP Key your product attempting to use.
Attempted to access a feature you Contact Technical Support to
have not been licensed to use. upgrade you license.
Windows does not recognize the HASP HL Key drivers were not device when the HASP HL key was Contact Technical Support properly installed inserted
Windows does not recognize the Lumax TS Pro Modem drivers were device when the Lumax units USB Contact Technical Support not properly installed cable is connected to the laptop
USB Port on Lumax is faulty Contact Technical Support
Be sure to use the DVD+R/W discs Cannot format the DVD backup disc Incorrect Media Type provided with the system.
Backup program is not saving the Configuration file incorrect Contact Technical Support data to the DVD
Be sure to use the DVD+R/W discs Incorrect Media Type provided with the system.
Ensure the DVD+R/W is properly Media not writable formatted.
Windows recognizes the Lumax Replace the USB cable and try Faulty USB cable device, but it is not communicating. again.
Contact Technical Support
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Trouble Shooting Guide (continued)
Error Condition Probable Cause Corrective Action
The Laptop software was closed and Windows communication issue. Unplug the USB cable and re-insert it. Lumax thinks it is still connected.
When the laptop is connected to Cannot review patients on the Lumax Laptop software is detected and Lumax, the review process must be unit. communicating. performed on the laptop.
Ensure that the Last and First Name Cannot send Patient Info to Monitor A required field is missing data. along with the Patient ID and a Valid Date of Birth has been entered.
Communication is not active Unplug the USB cable and re-insert it.
The race you are trying to add is Ensure the race you are trying to add Cannot add a race already defined as a system race. does not already exist.
Press the Show Patient Data button in Patient Data is Hidden User hid the patient data the upper right-hand corner.
Patient list contains fewer patients, Press the Clear Search button to view A search criterion is specified. and there were more entered. all system patients.
Select the Start menu, then All Programs, then Lumax TS Pro My Lumax TS Pro icon is gone from It was accidentally deleted. Advanced, and launch it from there. my desktop Contact Technical Support to add it back to your desktop
Customer Service: (800) 243-2974 Technical Support (800) 444-8456
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Made in USA
95 Corporate Drive, Trumbull, CT 06611 USA International
Phone: (800) 243-2974 Phone: +1 (203) 601-9818
Fax: (800) 262-0105 Fax: +1 (203) 601-4747
39249 • Rev. A • 03/19