LABORIE Urocap III Owner's Manual
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LABORIE Urocap III Owner's Manual

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LABORIE
Urocap III Owner's Manual
UC3-UM01-V22.00

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  • Page 1 LABORIE Urocap III Owner’s Manual UC3-UM01-V22.00...
  • Page 2 Tel.: +31.53.4803700 Fax: +31.53.4803701 www.laborie.com Urocap, Triton, AquariusTT, DoradoKT, Delphis, and i-LIST are trademarks of Laborie Medical Technologies Canada ULC Windows is a trademark of Microsoft Corp. Bluetooth is a registered trademark of Bluetooth SIG, Inc. Other names may be trademarks of their respective owners.

  • Page 3: Table Of Contents

    2.1. UNPACKING THE UROCAP III EQUIPMENT ......................... 7 Urocap III Wireless ........................................ 7 2.2. SETTING UP THE UROCAP III EQUIPMENT ......................... 9 2.3. EQUIPMENT STATUS AND INDICATOR LIGHTS ......................9 BI-COLOUR INDICATOR LED ....................................9 The Indicator LED provides important information on the status of the Urocap™ III................... 9 2.4.
  • Page 4 4.1. USING THE UROCAP™ III WIRELESS MODEL ......................44 PERFORMING A UROFLOW TEST ............................44 TRANSDUCER CALIBRATION ....................... 45 5.1. CALIBRATING THE UROCAP III WIRELESS MODEL ....................45 CLEANING AND PREVENTIVE MAINTENANCE ..................48 6.1. CLEANING ................................. 48 6.2. PREVENTIVE MAINTENANCE ............................ 48 Check the Flow and Volume of the Uroflowmeter .............................
  • Page 5 ENDNOTES ..............................67 LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 6: Introduction

    Uroflowmetry analysis. The purpose of this manual is to familiarize you with the installation, use, and operation of the Urocap III Uroflowmetry analyzer.

  • Page 7: Product Overview And Features

    RODUCT VERVIEW AND EATURES The Urocap III uses Uroflowmetry as a form of Urodynamic testing. The urinary flow rate and volume are measured and the results, in general, are used to verify or disprove patient symptoms via scientific methodology. Data acquisition occurs as the transducer collects and processes data. It prints the data in graphical form during the procedure, and is followed by a calculated Voiding Summary.

  • Page 8: Cautions And Warnings

    ONLY calibrate the transducer if necessary. Use with LABORIE equipment and accessories ONLY. ONLY Laborie trained technicians may service the unit. DO NOT ATTEMPT TO OPEN OR REPAIR the system by yourself or by an unauthorized party. LABORIE equipment and accessories are licensed by Governments and approved by Safety Agencies to work with EACH OTHER ONLY.
  • Page 9 In all cases it is advised to check with your local regulations before proceeding. 18. LABORIE is not responsible for loss of patient files or test data. We recommend that you back up patient data on a regular basis.
  • Page 10 43. Local laws take priority over the above-mentioned requirements and warnings. If in doubt, consult your local Laborie representative or the technical service department. 44. Do not place the printer in the patient environment unless it is powered via the Laborie provided Line Isolation Transformer (Separating transformer).

  • Page 11: Intended Use

    Uroflowmetry is a standard Urodynamic test that is often used as a screening test before moving on to more advanced Urodynamic studies such as Pressure or Micturition. The Urocap III is intended for use in Uroflowmetry studies that measure both flow rate and voided volume; and is intended for use by a qualified practitioner only.

  • Page 12: Urocap Iii Equipment And Accessories

    NPACKING ROCAP QUIPMENT The Urocap III is packaged for protection during shipment and transport. Verify that all ordered equipment and accessories have been received. Contact LABORIE should there be any discrepancies between ordered and received equipment. Inspect the equipment for any visible signs of damage or mishandling, and notify the carrier immediately if damage has been found.
  • Page 13 The bottom of the wireless model of the Urocap III contains an antenna that can be extended to provide better Bluetooth signal reception. PTIONAL CCESSORIES Depending on the setup of your Urocap III system, some of the items listed below may or may not be available as an optional accessory.  Flow stand  Uroflow Funnel ...

  • Page 14: Setting Up The Urocap Iii Equipment

    With the wireless model, the Bluetooth technology built into the Urocap III unit provides the patient with a higher degree of privacy during voiding. The transducer, beaker, commode chair, and funnel can be set up in one room while the PC can be in another room collecting the test data.

  • Page 15: Software Set Up

    The Urocap™ III wireless software is installed prior to shipping. Only install the software if it has been accidentally uninstalled or if you are upgrading to a more current version. Follow the instructions in the Software Installation Guide in the Laborie Software CD for your UDS system. III PC S...

  • Page 16: Logon Screen

    To open the UDS Client Window: 1. Double-click the UDS120 icon on the Windows desktop -OR- Click Start > All Programs > Laborie > UDS120. Result: The UDS Client opens with the UROCAP III Welcome Screen. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 17: File Menu

    Before opening a saved data file, be sure that any currently running patient tests are saved. Once the file is saved, opening a saved file automatically closes the old one. To open a saved file: 1. Click File from the menu bar. 2. Select Open. Result: The Open Test File window opens. LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 18 Set Directory Button: The Set Directory button allows you to see the location of the directory where all test data is saved. To change the directory, refer to the File Saving Director section on page 34. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 19: Save As

    To print the study 1. Click File > Print Study. Result: The Print Options dialog box appears. 2. Refer to the following diagram and its accompanying legend to select printing options. LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 20 Standard Standard Graph pages printed out with no compression or expansion applied Min/page Selectable number of minutes per graph page. Use the scroll bar to adjust the view. Segments Print the Uroflow graph segment LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 21: Batch Print (Optional)

    Result: The selected file appears in the Print Files box at the bottom of the screen. 3. Click Print. To cancel printing a file after it has been selected in the Print Files box: 1. Click on the file from the Print Files box. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 22: Print Setup

    The changes to the Printer setup will be applied to the printing process of the test. About UDS Client The About UDS Client dialog box displays the contact information for LABORIE’s Technical Support and formulas used in Urodynamics. It also includes the software version number, the ServerX version number, the Firmware version number, and the VBN version numbers (if applicable).

  • Page 23: Import Ics

    In this window you can fill in the areas with all the information that will help Laborie’s Support team identify the problem and provide a solution. Once you have filled in the information, click the Print button to print the cover sheet. Once it is printed, fax the sheet(s) to Laborie Support with the fax number provided.

  • Page 24: X-Y Plot

    • Patient names (first and last) can only be up to 44 characters in length. • Medical record numbers cannot contain a back slash (\) or a forward slash (/). X-Y Plot Siroky Nomogram The Siroky Nomogram was developed to provide an accurate and LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 25 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: 1.

  • Page 26: Event Summary

    1. Click on an event and click Annotate! Result: The Event Annotation box appears. 2. Enter the text in the text box using the keyboard or pick an item from the list. 3. Click OK. Result: The Event Annotation box closes. LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 27 3. i) To delete an event from the list, select it and click the Remove button. ii) To add a new event to the list, type it in the edit box and click the Add button. 4. After all the events are done, click the Save button LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 28: Voiding Summary

    Do not exist or current flow data is invalid: Uroflow Options box. 2. Perform one of the following procedures: To… Then click… Exit the Voiding Summary window: Change the channel and configuration parameters: Options. Result: The Uroflow Options box appears LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 29: Uroflow Options

    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). Auto Event Marking Automatically adds events to the graph. Auto Recording With Uroflow Auto Recording on, tests are automatically started and stopped once the transducer senses fluid in the beaker.
  • Page 30 Example: “Flow” may be replaced with another math channel depicting the corrected flow rate. NOTE: 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 a Channel 1.

  • Page 31: Artifact Recognition

    Example: If a patient kicks the transducer, the curve indicates a very high spike. The height of the spike is “unnaturally” high and therefore the Urocap III recognizes the event as a deviation from what it considers a normal reading.

  • Page 32: Upp Summary / Upp

    • You can change the scales by using the Options menu items. • You can close the Pediatric Nomogram window by clicking Exit! UPP Summary / UPP Not available with Urocap III. ARM 2 / ARM 4&8 Not available with Urocap III.

  • Page 33: Test Playback

    Select Test Playback. Uroflow Auto Start This enables the recording process as soon as the Urocap III detects the first flow of data. This selection is appropriate for Uroflowmetry studies in instances where the patient requires privacy before and during Micturition.

  • Page 34: Digital Value Indicator

    The number of rows can be modified if desired. To configure the Control Panel: 1. Click Options from the menu bar. 2. Select Control Panel Settings. Result: The Command window appears displaying the first row of Control Panel buttons. LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 35 NOTE 1: There are seven buttons on each row; the last two buttons of the first and second rows are reserved for system use. You can program the rest of the buttons. NOTE 2: Some of the commands listed are not applicable to the Urocap III. See the Control Panel Commands section on page 34 for a listing of available commands.

  • Page 36: Multiple Control Panel Sets And Hot Key Configuration

    Make any additional changes to the Control Panel Set. Click OK. Result: The new name and settings are saved and ready to use. NOTE: The original Control Panel set that was copied will not be erased. LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 37 Uroflow button: Click this button 3. In the Properties window, click the Browse button in the Image section to locate the image. Our picture in this example will be a picture of the Uroflowmeter. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 38: Customize Colors And Fonts

    You can also select to have all the buttons with the same color and font. Select the All Buttons option at the bottom of the window to apply the changes to all the control panel buttons. The chosen colors will display once you exit the Command window and return to the main UDS screen. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 39: Control Panel Commands

    1. Click Options > Auto Mark Peaks to enable Mark Peaks. Result: After running and stopping a test, a peak event for each channel is added. 2. Click Options > Auto Mark Peaks to disable Mark Peaks. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 40: Graph Clipping

    This menu item turns on or off the VBN normal curve overlay display. To view the Normal Curve Overlay: 1. Click File > Open to open any Pressure/Flow DTA file. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 41: Ilist

    ANAGER OPTIONAL This optional feature of the UDS120 software allows you to connect to different UDS devices by Laborie at the same time so that results for one patient can be recorded from different devices. Once the UDS120 software starts for the first time, the UDS devices will need to connect to the software.
  • Page 42 10. When the Calibration button for another UDS device is clicked a message box appears asking for the selection of the Flowmetry device to use for calibrating the Pump transducer. For example: If Urocap1 is to be chosen as the Flowmetry device to use with the pump, then calibrate the LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 43 Scroll down the list to the first empty line and begin by selecting the Device Name, then select the Device HW Channel and then select the UDS Screen Channel Name. Refer to the following charts for additional device/channel setups: Additional Urocap III Device UDS Screen Channel Name Device Name...

  • Page 44: Serverx Menu

    18. Setup of UDS120 software for a multiple device connection is complete. 2.11. S ERVER Daughter Download This menu item is reserved. Do not use. Pump/Transducer Calibration This menu item opens the Transducer Calibration window. Please refer to page 45 for instructions. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 45: Reset Connection

    The Show ServerX Window feature is to be used only by qualified technical service personnel. Choose Bluetooth UDS-94 This menu item is used to select which Urocap III Uroflowmeter is to be connected to the software. The software will automatically connect to the same Urocap III Uroflowmeter each time the software is opened and a test is selected.

  • Page 46: Additional Software Features

    3. ADDITIONAL SOFTWARE FEATURES The UDS software for Urocap III contains additional software features in a pop-up menu that can be accessed by right-clicking the UDS screen. 3.1.T ITLE UMERIC CALE Clicking either one of the four options allows you to change the appearance of the font (the writing) of the channel title, the channel numbers, the channel unit, and the channel scale.

  • Page 47: Change Channel Titles And Units (Optional)

    1. Click on a channel unit. Result: An edit box appears over the channel units. 2. Type the new channel units, replacing the old ones, and press Enter Result: The new channel units are displayed. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 48: Change Channel Scales (Optional)

    Result: An edit box appears over the channel scale. 2. Type the new channel scale replacing the old one and press Enter Result: The new scale of that channel is displayed. IDEO Not available with Urocap III. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 49: Running A Uroflow Test

    ERFORMING ROFLOW Plug the power cord of the Urocap III into a wall outlet. IMPORTANT! The Urocap-III power supply must be in a dry area at least one (1) metre away from the base of the commode chair. Start the UDS software. Wait for the red circle of the UDS Server to disappear to indicate connection made with the Urocap III.

  • Page 50: Transducer Calibration

    5. TRANSDUCER CALIBRATION The Urocap III uses software to calibrate the Uroflow transducer. There is no need to open the unit in order to calibrate the transducer. To receive instruction on calibrating the Urocap™ III, begin a software session by going to the Start Menu of Windows and selecting Programs >...
  • Page 51 500ml of water gradually into the beaker. 3. Start pouring the 500 ml of water at a constant rate of 25 – 40 ml/sec into the beaker. DO NOT TOUCH THE SIDES OF THE BEAKER. 4. Calibration is complete. LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 52 If the UDS120 software is not installed on the computer, the Urocap™ transducer can be calibrated through the Urostym ® CheckDB utility. Open the default calibration utility located in the C:\Program Files\Laborie Medical Technologies\Urostym ® \Utilities folder. Run the CheckDB utility.

  • Page 53: Cleaning And Preventive Maintenance

    See Calibrate Volume in the Calibration chapter in the owner’s manual for information. Once calibration is complete perform a re-check by following steps 1 to 5 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check. Check Flow 1.

  • Page 54: Virus Protection

    All computers purchased from LABORIE are virus-free before shipment and are installed with an Antivirus program. It is the customer’s responsibility to correctly use and maintain the antivirus program to prevent virus problems. LABORIE is not responsible for any virus related computer problems after point of delivery to the customer.

  • Page 55: Troubleshooting

    If the system is not working properly, please use the following troubleshooting table to identify the problem. If the problem cannot be resolved by the following methods, please contact LABORIE. DO NOT ATTEMPT TO REPAIR OR SERVICE THE DEVICE YOURSELF.
  • Page 56 Re-position the PC or Urocap III so that there is no barrier (open air) between them. Move the computer and Urocap III closer together. [The maximum distance allowed between the...
  • Page 57 Note: The Laborie Urocap III has a medical grade power supply available for the laptop and Urocap III, 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 58: Appendices

    23 Kg (50 lbs.) Maximum Study Length 10 min Transportation and Storage Conditions Temperature: -29°C to 60°C Humidity: uncontrolled to 85% relative humidity Operating Conditions Temperature: 15°C to 35°C Humidity: 20% to 80% Pressure: 700hPa to 1014hPa LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 59: Equipment/Accessory Part Numbers

    Refer to EC Declaration of Conformity for latest revision of applicable regulations and standards • Upon request, LABORIE will make available to the customer, any circuit diagrams, component part lists and other technical documentation directly related to the Urocap III.

  • Page 60: Appendix B. Symbols And Labeling

    EN ISO 15223-1 Medical Devices – Symbols to be used with medical device, labels, labelling and information to be supplied – Part 1: General Requirements. ISO 7000:2014 – Graphic Symbols for Use on Equipment – Registered Symbols. CAN/CSA-C22.2 No. 60601-1:14 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. LABORIE logo LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 61: Appendix C. Electromagnetic Compatability (Emc)

    Testing and Measurement Techniques – Immunity to Conducted Disturbances, Induced by Radio-Frequency Fields. 2003+A1:2004+A2:2006 IEC 61000-4-8: 2009 Testing and measurement techniques – Power frequency magnetic field immunity test IEC 61000-4-11: 2004 Testing and measurement techniques – Voltage dips, short interruptions and voltage variations immunity tests LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 62: 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. 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 63: Iec 60601-1-2: 2014 - Table 1 Requirements

    IEC 60601-1-2:2014 – TABLE 2 REQUIREMENTS The Urocap III is intended for use in the electromagnetic environment specified below. The customer or the user of the Urocap III should assure that it is used in such an environment. Immunity Test...
  • Page 64 30 A/m 30 A/m in a typical commercial or hospital (50/60 Hz) environment. IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 65: Iec 60601-1-2: 2014 - Table 4 Requirements

    If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 66: Iec 60601-1-2: 2014 - Table 6 Requirements

    IEC 60601-1-2: 2014 – TABLE 6 REQUIREMENTS Recommended separation distances between portable and mobile RF communications equipment and the Urocap III ® The Urocap III ® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The...

  • Page 67: Appendix D. End-User Software License Agreement

    APPENDIX D. END-USER SOFTWARE LICENSE 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/ LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 68: Voiding Summary Analysis

    VOIDING SUMMARY ANALYSIS APPENDIX E. The Voiding Summary printout created by the Urocap III supplies a comparison to the Nomogram tables. They are provided for both male and female patients on the same printout. The comparison is provided in a percent difference from the table value. Following is the mathematical formula used in the calculations: PeakFlow −...

  • Page 69: Appendix F. Nomogram Tables For Uroflowmetry

    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 III Owner’s Manual UC3-UM01...
  • Page 70 10.4 26.9 22.2 17.6 46.5 37.4 28.4 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 LABORIE Urocap III Owner’s Manual UC3-UM01...

  • Page 71: Appendix G. Accessory Descriptions

    Urocap III Transducer The Urocap III uses a weight transducer to measure both volume and flow rate. A beaker is placed on top of the transducer. When urine is collected in the beaker, the transducer detects the change in weight and the Uroflow procedure starts.
  • Page 72 Haylen BT, Ashby D, Sutherst JR, Frazer MI and West CR. Maximum and Average Urine Flow Rates in Normal Male and Female Populations – the Liverpool Nomograms. British Journal of Urology 1989; 64:30-38. Churchill BM, Gilmour RF, Williot P. Urodynamics. Pediatr Clin North Am. 1987;34:1133–1157. LABORIE Urocap III Owner’s Manual UC3-UM01...
  • Page 73 LABORIE Urocap III Owner’s Manual UC3-UM01...

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