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Related Manuals for LABORIE UROCAP IV
Summary of Contents for LABORIE UROCAP IV
- Page 1 UROCAP™ IV Owner’s Manual Standalone Model LABORIE Urocap™ IV Owner’s Manual – UC4-UM01-V13.00...
- Page 2 TRADEMARKS Urocap is a trademark of LABORIE Medical Technologies Canada ULC. Bluetooth is a registered trademark of Bluetooth SIG. Android is a trademark of Google Inc. Wi-Fi is a registered trademark of the Wi-Fi Alliance. MOTOROLA and product images are trademarks or registered trademarks of Motorola Trademark Holdings, LLC.
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Page 3: Table Of Contents
Device Connector and System Reset Button ....................24 Software Features and Functions ..........................24 Quick Start ............................... 25 File Menu ................................. 25 6.2.1 Open ................................25 6.2.2 Open from Data File ........................... 25 6.2.3 Save As ................................ 25 LABORIE Urocap IV Owner’s Manual UC4-UM01... - Page 4 Troubleshooting ..............................49 11.1 Urocap™ IV ..............................49 11.2 Bluetooth Connection ............................ 50 11.3 Software Error Messages ..........................51 11.4 Printer ................................51 Appendices ................................. 52 APPENDIX A. Specifications and System Information ....................52 LABORIE Urocap™ IV Owner’s Manual UC4-UM01...
- Page 5 Figure 19 – iList Office Report Section Overview ......................47 Figure 20 – Selecting Report Template ......................... 47 Figure 21 – Calibrating the Urocap™ IV with UDS120 ....................48 Figure 22 – Print Options Window ..........................60 LABORIE Urocap IV Owner’s Manual UC4-UM01...
- Page 6 Table 29 – Separation Distance Requirements ......................59 Table 30 – Print Preferences Options ..........................61 Table 31 – Nomogram Tables – Male ..........................63 Table 32 – Nomogram Tables - Female ......................... 63 LABORIE Urocap™ IV Owner’s Manual UC4-UM01...
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Page 7: About This Manual
Provides information users need to know in order to prevent minor injury or product damage. IMPORTANT Provides important information regarding use of device or software NOTE Provides useful information or reminders while operating the device or software. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 8: Introduction
1 INTRODUCTION LABORIE’s Urocap™ IV is a simple and easy-to-use Uroflowmeter with built-in comparative studies. These studies, along with other unique features, will deliver highly accurate Uroflowmetry recordings that are easy to produce and interpret. An added feature is the built-in Bluetooth® technology — providing you with the ease and flexibility of wireless connection to perform all your Uroflowmetry procedures. -
Page 9: Cautions And Warnings
DO NOT ATTEMPT TO OPEN OR REPAIR the Urocap™ IV system components by yourself or by an unauthorized party. ONLY Laborie-trained technicians may service the Urocap™ IV system components. • LABORIE equipment and accessories are licensed by Governments and approved by Safety Agencies to work with each other ONLY. •... - Page 10 Before the procedure, verify that the Urocap™ IV system components and software are functioning properly. • LABORIE is not responsible for loss of patient files or test data. It is strongly recommended to back up patient data on a regular basis.
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Page 11: Intended Use
The major application of Urodynamics (including Uroflowmetry) is the diagnosis of uncontrolled loss of urine (incontinence) or abnormal urinary retention. CONTRAINDICATIONS The Urocap™ IV Uroflowmetry analyzer is contraindicated in any patient who is not a candidate for Uroflowmetry testing. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 12: Cleaning And Maintenance
Urocap™ IV every 6 months, or whenever you suspect the transducer is off calibration. • Pay close attention to the LED lights on the device. If they indicate a broken connection and/or low battery, make sure that the connection is re-established or battery is fully charged. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 13: Battery: Charging And Maintenance
• Do not step on, drop, immerse in water, or puncture the battery. If misuse, abuse or damage is suspected – or any form of mechanical damage to the casing is visible – discontinue use and contact LABORIE service. •... -
Page 14: Environmental Consideration Of Waste Disposal
4 DEVICE SETUP PERFORM AN EQUIPMENT CHECK Verify that all ordered equipment and accessories have been received. Contact LABORIE if there are any discrepancies between ordered and received equipment. Inspect the equipment for any visible signs of damage or mishandling. Notify the carrier immediately if damage has been found. Carrying cases and cartons should be saved to provide a convenient and safe way to return the equipment should service be required. -
Page 15: Table 1 - Standard Equipment
DESCRIPTION The wireless printer connects to mobile devicess via WIFI and provides a printout of test results. Please speak with a Laborie representative to learn about the recommended printer for your region. Wireless Printer The folding commode chair and funnel are both made of sturdy materials. -
Page 16: Set Up Equipment
INSTALL SOFTWARE If not already installed on the laptop, please refer to the System Installation Guide for Laborie UDS Systems with Windows 10® on the LABORIE software USB to install the Urocap™ IV standalone software. - Page 17 Server window, highlight the name and then click OK. When a connection is established, the Bluetooth address and serial number fields will display the device information. 9. Click OK to go back to the Urocap™ IV Device Manager window. LABORIE Urocap IV Owner’s Manual UC4-UM01...
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Page 18: Wireless Printer Setup
When the Urocap™ IV is connected and functioning, the Urocap™ IV Device Manager window will look similar to this: WIRELESS PRINTER SETUP 4.5.1 BEFORE YOU BEGIN Ensure the following: ● The wireless network is set up and working properly. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 19: Set Up The Printer On Your Wireless Network
● Wi-Fi Direct cannot be used to connect a computer, mobile device, or printer to the Internet. To Turn On Wi-Fi Direct 1. On the printer control panel display, from the Home screen, touch (Wi-Fi Direct). LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 20: Change The Connection Type
(for example, from a USB connection to a wireless connection). To Change From a USB Connection to a Wireless Network (Windows) 1. Open the HP printer software. 2. Click Tools. 3. Click Device Setup & Software. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... - Page 21 Note: A USB connection between the computer and printer can only be used if these two devices are isolated from the patient environment to reduce the risk of electric shock to the patient. Laborie highly recommends that a wireless connection is used between the computer and printer at all times.
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Page 22: Device Features And Functions
When there is a connection failure, you will need to re-connect the Urocap™ IV. Click the device button to re-connect. If the device does not connect after this attempt follow the steps starting on page 50 for more information LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 23: Battery Status
UrocapIV Low Battery Shutdown will be marked on the graph. Stop the test, plug the device into the charger, and reconnect as described on page 13. Table 5 – Device Manager Battery Status indicator Icons LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 24: Device Connector And System Reset Button
The menus in the menu bar at the top of the Urocap™ IV software window contain items that allow you to view saved test files, to customize the appearance of the control panel, and to view test summaries. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 25: Quick Start
Click the Uroflow Auto Recording button to automatically start, stop, and open the iLIST Reporter software. FILE MENU The File menu contains items that allow you to view saved files as well as view contact information for LABORIE’s support department. -
Page 26: Print Study
Click the Fax Cover button to open the Fax Cover sheet window that can be sent to the Support department for inquiries into any problems you may be experiencing with the equipment or software. Once you have filled in the information, click the Print button to print the cover sheet and then fax the sheet to LABORIE’s support department. -
Page 27: Set Up/Modify (Optional)
The Printable option allows you to see the graph curves on the test results printout. Select include the curve in a printout. • Curve Overlay allows you to display up to 5 channel curves on the same graph on the display and print out. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 28: Figure 8 - Configuration Window, Security Tab
Office Reporter will display only the events that appear in the list under this tab. Also, the Annotation Alias needs to exactly match what you mark on the UDS test in order to appear in the Event Summary. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 29: Unlock Cfg
Figure 9 – Unlock CFG Make changes as needed and when complete click the Lock CFG button. Click Yes in the resulting warning message to lock the configuration file. Figure 10 – Lock CFG LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 30: Info Menu
SIROKY NOMOGRAM (OPTIONAL) The Siroky Nomogram was developed to provide an accurate and reliable indication of outflow obstruction. software provided by LABORIE will help you compare the results of a patient’s pre-therapy and post-therapy Uroflow test. To view the Siroky Nomogram click Info > X-Y Plot > Siroky Nomogram. -
Page 31: Figure 12 - Siroky Nomogram Window
LIVERPOOL NOMOGRAM (OPTIONAL) The Liverpool Nomogram was developed to provide an accurate and reliable indication of normal Uroflow rates. You can compare a patient’s pre-therapy and post-therapy urinary flow rate with Laborie’s software and the built- in Liverpool Nomograms. To view the Liverpool Nomogram click Info > X-Y Plot > Liverpool Nomogram. -
Page 32: Event Summary
Click Info > Event Summary to list in chronological order. Add or change event annotation 1. Highlight an event and click Annotate! 2. Type the text in the text box or pick from the list. 3. Click OK. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 33: Voiding Summary
Click Info from the menu bar and select Voiding Summary. The Voiding Summary printout supplies a comparison to the Nomogram tables. They are provided for both male and female patients on the same printout. Figure 16 -- Voiding Summary Window LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 34: Uroflow Options
Enable Artifact Recognition Select check box to enable Artifact Recognition Threshold Indicates the maximum acceptable change in Flow (acceleration) that is physiologically possible. OEM Uroflow Transducer Original Equipment Manufacturer (for optional non-Laborie Uroflow transducers). LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 35: Options Menu
The calculating channels may be replaced with other channels as long as the units are consistent in definition. Normally the default settings for threshold are not changed for performing Uroflowmetry on patients. Consult with your LABORIE representative for modifications to default settings. TO CHANGE THE TIME RANGE: 1. -
Page 36: Uroflow Auto Start
5 basic control panels set in the software when first installed, however other panels can be configured if desired. There are seven control panel buttons on each row; the number of rows can be modified if desired. To configure the Control Panel: LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 37: Table 7 - Configuring Control Panel Settings
Click on the down arrow of the appropriate combo box to the right of each button’s button: function. Select the appropriate function command type. Repeat until the type of all function buttons in the row are set. Table 7 – Configuring Control Panel Settings LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 38: Table 8 - Control Panel Commands
2. Click the PLUS (+) button to open the selection box. 3. Select Siroky and click OK. 4. Name the button in the Label column. 5. Click OK to set the button on the control panel. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 39: Table 9 - Configuring Control Panel Sets
CTRL+R to the First Sensation button. 4. Click OK. Table 9 – Configuring Control Panel Sets The PLUS (+), MINUS (-), and EQUAL (=) keys can also be used for the Hot Key configurations. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 40: Table 10 - Adding An Images To Control Panel Buttons
5. Click OK, and then click OK again to close the window. The image will now appear in the button on the control panel. Before (Text only) After (Uroflowmeter image with text) Table 10 – Adding an Images to Control Panel Buttons LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 41: Figure 17 - Select Color Window
By default, this option is disabled and the curves can exceed the display area of a channel. Click Options from the menu bar. Select Graph Clipping. Click > Options Graph Clipping to cancel the Graph Clipping option. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 42: Table 11 - Modifying Graph Appearance
4. Repeat step 2 for any other channels. 5. Right-click directly on the channel area to and select Change Channel Order again from the pop-up menu to set the changes in place. Table 12 – Adapting Channel Order LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 43: Table 13 - Adjusting Event Marker Location
Unit Font or Scale Font menu items. 3. Pick the font from the resulting Font selection window and click OK to set the changes. Table 14 – Adjusting Channel Font SET ZEROES Click this to zero channels as needed. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 44: Run A Uroflow Test
When the Patient Information screen appears, enter information, as necessary, and click OK. Straight catheterize patient to obtain post void residual measurement. Remove the catheter. When the Voiding Summary screen appears enter the PVR value and click OK. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 45: Manual Method
Instruct the patient to void; provide privacy if possible. When voiding is complete click Stop. Straight catheterize patient to obtain post void residual measurement. Remove the catheter. Click Info and Voiding Summary. Enter the post-void residual volume in the PVR box. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 46: Print A Test
The main window contains the same general layout for each type of report. iLIST Office Reports contain information gathered from the Patient Info screen as well as the saved test files from the Urocap™ IV software. LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 47: Figure 19 - Ilist Office Report Section Overview
To select a report template click the name in the Report(s) heading and click a selection from the listing. Figure 20 – Selecting Report Template To print a report, click the Print icon on the toolbar in the iLIST Office Reporter software. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 48: Calibration
See Section 5.1 for a chart listing LED light status. How do I charge the Urocap™ IV? See Section 3.1 for more information about charging the devices. Can I still use the Urocap™ IV while battery is charging? LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 49: Troubleshooting
Computer or printer No power or power cord connected Ensure electrical outlet is working, power does not power on improperly cords are not damaged and all cords are secure at both ends. LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 50: Bluetooth Connection
Funnel is touching the beaker Adjust commode chair or Urocap™ IV Incorrect beaker is in use Use beakers supplied by LABORIE only Error message on Water was poured into beaker too Pour water slowly and at a steady rate... -
Page 51: Software Error Messages
If problems continue, contact LABORIE’s Service team at 1-800-333-1039 or email service@laborie.com. Note: The Laborie Urocap IV has a medical grade power supply available for the laptop, but the desktop printer is not medically isolated and must not be used within the patient environment or directly connected to the laptop if the laptop is within the patient environment. -
Page 52: Appendices
12 APPENDICES APPENDIX A. SPECIFICATIONS AND SYSTEM INFORMATION Upon request, LABORIE will make available any circuit diagrams, component part lists, and other technical documentation directly related to the Urocap™ IV. Urocap™ IV (TRA851) Dimensions: 6.3”(16.0cm) L X 6.3”(16.0cm) W X 2.6”(6.6cm) H Weight: 0.7lbs (0.3kg) -
Page 53: Applicable Standards And Directives
CAN/CSA-C22.2 No. 60601-1:14 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. ISO 7000:2014 – Graphic Symbols for Use on Equipment – Registered Symbols. IEC 60417 – Graphic Symbols for Use on Equipment. Table 24 – Symbols Glossary LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 54: Appendix C. Electromagnetic Compatability (Emc)
Testing and measurement techniques – Electrical fast transient/burst IEC 61000-4-4: 2012 immunity test IEC 61000-4-5: 2005 Testing and measurement techniques - Surge immunity test IEC 61000-4- Testing and Measurement Techniques – Immunity to Conducted Disturbances, Induced by Radio-Frequency Fields. 6:2003+A1:2004+A2:2006 LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 55: Appendix D. Tables Of Guidance And Declaration Regarding Electromagnetic Immunity
• Consult the dealer or experiences technical personnel for help. Changes or modifications not expressly approved by LABORIE could void the user’s authority to operate the equipment. 2. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. -
Page 56: Iec 60601-1-2: 2014 - Table 1 Requirements
Table 26 – Electromagnetic Environment Emissions Requirements, Compliance, and Guidance IEC 60601-1-2:2014 – TABLE 2 REQUIREMENTS The Urocap IV is intended for use in the electromagnetic environment specified below. The customer or the user of the Urocap IV should assure that it is used in such an environment. -
Page 57: Iec 60601-1-2: 2014 - Table 4 Requirements
3 Vrms Portable and mobile RF communications 61000-4-6 150 kHz to 80 equipment should be used no closer to any part of the Urocap IV including 6Vrms for ISM cables, than the recommended bands separation distance calculated from the equation applicable to the frequency of the transmitter. -
Page 58: Iec 60601-1-2: 2014 - Table 6 Requirements
The Urocap IV ® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Urocap IV ® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Urocap IV ®... -
Page 59: Appendix E. End User License Software Agreement
Table 29 – Separation Distance Requirements APPENDIX E. END USER LICENSE SOFTWARE AGREEMENT Find licenses and terms for LABORIE products and services in the following locations: End User License Agreement: http://www.laborie.com/eula/ Terms and Conditions: http://www.laborie.com/terms-and-conditions/... -
Page 60: Appendix F. Print Options For Uds120 Goby Software For Urocap™ Iv
Preferences: Graph Pages/Report Pages Graph pages of UDS report with Report pages. Standard Report Prints all information pertaining to study. Voiding Summary Uroflow Summary information. Event Summary Event Summary information. Compliance Prints compliance calculations LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 61: Table 30 - Print Preferences Options
Font Opens a window that allows you to set the font for each section of the report. Double-click the titles to set the font. Table 30 – Print Preferences Options LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 62: Appendix G. Nomogram Tables For Uroflowmetry - Male
12.0 32.4 26.0 19.7 37.6 29.5 21.4 27.1 21.8 16.5 12.1 32.8 26.4 20.1 37.7 29.6 21.5 27.2 21.9 16.6 12.1 33.2 26.8 20.5 37.9 29.8 21.7 27.4 22.0 16.7 12.2 33.6 27.3 20.9 LABORIE Urocap™ IV Owner’s Manual UC4-UM01... -
Page 63: Appendix H. Nomogram Table For Uroflowmetry - Female
30.3 24.3 18.4 10.4 27.2 22.5 17.8 47.1 38.0 29.0 30.4 24.5 18.6 10.3 27.5 22.8 18.1 47.7 38.7 29.6 30.6 24.7 18.8 10.2 27.7 23.1 18.4 Table 32 – Nomogram Tables - Female LABORIE Urocap IV Owner’s Manual UC4-UM01... -
Page 64: Appendix I. Glossary
This group sets standards for Urodynamic testing that all LABORIE training follows. lower urinary tract symptoms: (LUTS) these may include frequency, urgency, incontinence, nocturia, recurrent urinary tract infections, and many others. -
Page 65: Common Acronyms
A Cannon. AW Thomas, E Bartlett, J Ellis-Jones, L Chambers and P Abrams. BLADDER CONTRACTILICITY AND VOIDING EFFICIENCY IN MEN WITH BLADDER OUTLET OBSTRUCTION TREATED CONSERVATIVELY AND BY TURP. Bristol Urological Institute, Bristol, United Kingdom. Informally discussed posters, ICS 2000 Tampere. LABORIE Urocap IV Owner’s Manual UC4-UM01...
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