LABORIE PrimeSight UNITY UVP-9000 User Manual
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LABORIE PrimeSight UNITY UVP-9000 User Manual

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PrimeSight
DIGITAL VIDEO PROCESSOR
User Manual
UVP-9000
UNITY
™

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Summary of Contents for LABORIE PrimeSight UNITY UVP-9000

  • Page 1 PrimeSight UNITY ™ DIGITAL VIDEO PROCESSOR User Manual UVP-9000...
  • Page 2 NOTE: Federal (USA) law restricts this device to sale by, or on the order of, a physician or other appropriately licensed medical professional. © 2018, 2019, 2020 LABORIE. All rights reserved. Printed in the United States of America. The information contained herein is the exclusive and confidential property of LABORIE.

  • Page 3: How To Use This Manual

    Videoscopes. Thoroughly review the User Manual for the endoscope that will be used in conjunction with the Video Processor. If you are a first time user, LABORIE strongly recommends that you read this manual from beginning to end and become intimately familiar with the Video Processor and its use.

  • Page 4: Additional Information

    Video Processor, and suggests corrective actions that may assist in solving them. Chapter 9, Warranty and Service – This chapter contains the terms of the LABORIE warranty on the Video Processor, any restrictions that apply, and user actions that may void the warranty if taken.

  • Page 5: Table Of Contents

    TABLE OF CONTENTS HOW TO USE THIS MANUAL ........................I Organization of this Manual ........................i Additional Information ..........................ii SYMBOLS AND TERMS ........................1 Symbols Glossary ........................1 Terms ............................3 IMPORTANT INFORMATION ......................4 Indications for Use ........................4 Intended Use ..........................4 User Qualifications ........................5 Maintenance and Repair ......................5 Signal Words ..........................5 Safety Precautions ........................6 Before Use ...........................6...
  • Page 6 UVP-9000 Error Messages ......................53 Endoscope Issues ........................53 WARRANTY AND SERVICE ......................54 Warranty Information ........................54 LABORIE Service Information ....................54 Shipping to LABORIE or Distributor ..................55 APPENDIX/SPECIFICATIONS .........................56 Specifications ..........................56 Electromagnetic Compatibility Declarations .................57 Software License Notifications ....................62 The PrimeSight UNITY 9000 Video Processor User Manual...
  • Page 7 INDEX OF FIGURES Figure 3-A: UVP-9000 Front View .......................... 11 Figure 3-B: UVP-9000 Rear Panel Left Side ......................12 Figure 3-C: UVP-9000 Rear Panel Right Side ......................13 Figure 3-D: Flip-Up LCD Monitor on UVP-9000 ....................14 Figure 3-E: Videoscope Control Buttons ......................15 Figure 3-F: Connect the Videoscope Cable to the Video Processor ..............
  • Page 8 INDEX OF TABLES Table 3.3: The PrimeSight UNITY 9000 Video Processor Standard Set and Accessories ........10 Table 4.3.1: Patient Sub-Menu ..........................26 Table 4.3.2: Patient Directory Sub-Menu .......................27 Table 4.3.5-A: Setup Sub-Menu ..........................34 Table 4.3.5-B: Backup and Restore Functions .......................36 Table 4.3.5-C: Security Functions ...........................37 Table 6.2: Enhance Pop-up Menu ..........................42 Table A-2.1: Electromagnetic Emissions Declaration ...................57 Table A-2.2: Electromagnetic Immunity Declaration ....................58...

  • Page 9: Symbols And Terms

    SYMBOLS AND TERMS SYMBOLS GLOSSARY The symbols listed below can be found on the PrimeSight UNITY 9000 Video Processor and on other components of the system. Symbol Title Symbol Description of Symbol [Reference Number] Manufacturer Indicates the medical device manufacturer [5.1.1] Alternating Current Denotes device uses alternating current...
  • Page 10 1 - Symbols and Terms SYMBOL TITLE SYMBOL DESCRIPTION OF SYMBOL [REFERENCE NUMBER] Authorized Representative in Indicates the device’s Authorized representative within the European Community the European Community [5.1.2] 60°C Temperature Limit Indicates the temperature limits to which the medical [5.3.7] device can be safely exposed -20°C...

  • Page 11: Terms

    1 - Symbols and Terms TERMS The following terms are used throughout this User Manual: “Processor,” “Video Processor,” “Equipment” or “Unit” refers to the PrimeSight UNITY 9000 Video Processor. “System” or “Endoscopic System” refers to a Video Processor with an endoscope connected to it. “UNITY 9000”...

  • Page 12: Important Information

    INTENDED USE The UNITY 9000 is intended to be used with a LABORIE flexible videoscope to form an endoscopy system utilized for the following indications: FLEXIBLE...

  • Page 13: User Qualifications

    Processor. Doing so may cause further equipment damage and/or compromise patient safety if the Processor is subsequently used in a procedure. The Processor may only be serviced or repaired at an authorized LABORIE facility. In addition to thoroughly inspecting the Processor before each procedure, periodic inspections should be performed to determine if there is wear or damage that requires attention.

  • Page 14: Safety Precautions

    Should this equipment be mishandled or dropped, do not use it. Return it to an authorized LABORIE service facility for inspection and repair. Carefully inspect all equipment before using it in a procedure, and do not use any equipment that is damaged or excessively worn.

  • Page 15: During Use

    2 - Important Information DURING USE Ensure that there is no patient contact with this equipment. Doing so can cause patient and/or operator injury. Consult the applicable endoscope User’s Manual for warnings regarding safe use of the endoscope including: excessive temperature rise, use of energized endotherapy and laser accessories, leakage current and mechanical hazards.

  • Page 16: Equipment Overview And Preparation

    3.0 EQUIPMENT OVERVIEW AND PREPARATION THE PRIMESIGHT UNITY 9000 VIDEO PROCESSOR The PrimeSight UNITY 9000 Video Processor is designed to work exclusively with the LABORIE 5000 Series of videoscopes as listed in the intended use. The Video Processor anchors a complete endoscopic solution for clinical settings, delivering optimal image quality, ease-of-use, and reliability.
  • Page 17 3 - Equipment Overview and Preparation • Multilingual support for on-screen displays and menus • International keyboard support; USB port for external keyboard • Internal 500GB storage for patient data and image/video capture and management • Additional USB ports for external keyboard, USB storage backup and printers •...

  • Page 18: Inspect The Standard Set

    3 - Equipment Overview and Preparation INSPECT THE STANDARD SET When the Video Processor is received from LABORIE, immediately confirm that the appropriate items listed in Table 3.3 were received, and inspect them for damage. If any item is missing or damaged, do not use the equipment;...

  • Page 19: Uvp-9000 Front Panel And Functions

    3 - Equipment Overview and Preparation UVP-9000 FRONT PANEL AND FUNCTIONS Figure 3-A shows the front view of the PrimeSight UNITY UVP-9000 Video Processor. This section describes the functions of the buttons and switches on the front panel. Figure 3-A: UVP-9000 Front View 1.

  • Page 20: Uvp-9000 Rear Panel And Functions

    Figure 3-B: UVP-9000 Rear Panel Left Side For connecting to an Ethernet local area network. Identification Tag Identifies LABORIE contact information, the unit’s catalog number and unique serial number, and compliance symbols. Remote 1 and Remote 2 Feature not supported.

  • Page 21: Figure 3-C: Uvp-9000 Rear Panel Right Side

    3 - Equipment Overview and Preparation Figure 3-C: UVP-9000 Rear Panel Right Side DisplayPort Digital Video Interface output supporting HD resolution display on external digital monitors (HDMI or DVI interface requires appropriate adapter cable). Three USB 3.0 Master ports for connection to USB devices; USB connections may be used to connect to external keyboard, USB printer, foot pedal, external storage such as USB memory stick or hard drive, or to power analog speakers with USB power connector.

  • Page 22: Lcd Monitor

    3 - Equipment Overview and Preparation LCD MONITOR The PrimeSight UNITY 9000 Video Processor displays the endoscopic image on the Processor’s integrated, “flip-up” LCD monitor (see Figure 3-D). Figure 3-D: Flip-Up LCD Monitor on UVP-9000 The monitor screen displays information in designated areas. These include: •...

  • Page 23: Compatible Videoscopes And Cameras

    3 - Equipment Overview and Preparation COMPATIBLE VIDEOSCOPES AND CAMERAS The LABORIE UNITY 9000 is designed to operate with the LABORIE 5000 Series Videoscopes and the DCH-5000 Add-on Camera. These Videoscopes have the following features: • A CCD-based imaging system •...

  • Page 24: Accessories

    (IEC 60601-1 and/ or IEC 60601-1-1). The use of accessories not specified in this manual or sold by LABORIE may result in increased electro-magnetic emissions or decreased electromagnetic immunity of the equipment or system. For advice on compatibility, contact your distributor or the LABORIE Customer Care.

  • Page 25: Connect The Videoscope To The Video Processor

    When using an isolation transformer for any peripheral equipment, ensure that the power requirements of the equipment do not exceed the capacity of the isolation transformer. For further information, contact your local LABORIE representative. The PrimeSight UNITY 9000 Video Processor User Manual...

  • Page 26: Cables

    3.12 CABLES Always attach cables to the rear panel of the Video Processor first, and then connect them to the peripheral equipment. Only use approved cables from LABORIE (see Table 3.3 for a list of approved cables). Figure 3-G: Rear Panel Cable Connections 3.13 CONNECT AN AC POWER CABLE...

  • Page 27: Inspect The Assembled System

    3 - Equipment Overview and Preparation 3.14 INSPECT THE ASSEMBLED SYSTEM Before performing the procedure, thoroughly inspect the system. • Confirm that all cords and cables are connected properly and are secure. • Confirm that the equipment and all components function properly, including all switches, indicators, etc.

  • Page 28: User Interface

    4.0 USER INTERFACE DISPLAY LAYOUT The video display is organized in four main areas (Figure 4-A): • Left Side Icon Panel: Main system control icons • Right Side Icon Panel: Shortcut and function icons • Image Window: Procedural video images or saved still images or videos occupy the center of the screen.

  • Page 29: Figure 4-B: Monitor Display (On-Screen Messages And Indicators During Imaging)

    4 - User Interface 4.1.1 Status Messages Messages are displayed in the Message Area in the lower right corner of the image area (Figure 4-B). These messages could include: • White balance in process • White balance OK • White balance failed •...

  • Page 30: Icon Functions

    4 - User Interface ICON FUNCTIONS The touchscreen icons on the Video Processor display enable you to directly activate all of the device’s functionality. The main screen provides access to all of the Video Processor’s settings and functions. Icons on the display are used to invoke functions using the touchscreen or when another pointing device such as a trackpad is used to select the icon.
  • Page 31 4 - User Interface Displays Enhance pop-up window with image controls. ENHANCE Sends current image (live or video playback) frame to the active printer. PRINT Icon must be pressed for 2 seconds before initiating the White Balance function. • White balance will take several seconds to perform. While the White Balance is in process, hold the endoscope tip steady approximately 1 to 2 inches away from the white target.
  • Page 32 4 - User Interface FUNCTIONS FOR SHORTCUT BUTTONS, SCOPE BUTTONS OR FOOT PEDAL: Freezes image in main display window and display live reference image in the thumbnail window. Press again to resume live imaging. FREEZE Adjusts the Zoom in increments of 10% (0.1), from 110% (1.1) up to 200% (2.0), then wraps around back to Zoom of 1.0.
  • Page 33 4 - User Interface PATIENT ARCHIVE REVIEW CONTROLS • Review Controls are displayed when the Patient Archive function is selected. • Inactive until image/video selected for review. • If thumbnail view of patient images/video is displayed, then all controls are not available. Starts playback of video clip.

  • Page 34: Main Controls

    4 - User Interface MAIN CONTROLS This section provides basic instructions on how to navigate through the Video Processor’s system of menus and sub-menus. The six main workflow icons on the left side of the screen represent high level functions relevant to the user, the patient, and image display and management features. Each menu category and its associated sub-menu settings and options are described in this section.

  • Page 35: Figure 4-D: Patient Directory Screen

    4 - User Interface Patient Directory The Video Processor’s Patient Directory sub-menu options are described in Table 4.3.2 below: Figure 4-D: Patient Directory Screen FUNCTION OPTIONS Add to List Adds the selected patient to the Day List Create Patient Opens the Create Patient screen to input a new patient, automatically added to the archive.

  • Page 36: Figure 4-E: Patient Information Entry Screen

    4 - User Interface Create Patient Selecting this option brings up an entry screen (Figure 4-E) to input new patient information, which is automatically added to the Archive: Figure 4-E: Patient Information Entry Screen Patient Information / Data Fields Nine fields on the display are available for the entry of patient information. Use the tab key to move through the patient information entry fields.
  • Page 37 4 - User Interface Date of Birth (DOB) Enter the patient’s date of birth. DOB is a mandatory field. Gender Select the appropriate gender for the patient from the list (Male/Female/Other). Gender is a mandatory field. Note The user may enter patient-specific information in this field (medical history, recent diagnosis, or other pertinent or useful notes) Inactive Selecting the Inactive option will hide the patient in the directory and prevent the patient...

  • Page 38: Figure 4-F: User Login Input Pop-Up

    4 - User Interface 4.3.2 User Icon and Screens The second screen icon is User. The User function allows a user to log into their account (Figure 4-F) for access to the patient archive of images and video clips and to manage their personalized settings on the system.

  • Page 39: Figure 4-G: Archive Screen For Current Patient

    4 - User Interface 4.3.4 Archive Screen The fourth screen icon is Archive. Pressing Archive will display the stored images and video for the currently selected patient (Figure 4-G). Figure 4-G: Archive Screen for Current Patient Notes: a) One to six still images or video clips from the thumbnails may be selected by touching the image/video thumbnail for either review or exporting to external storage.

  • Page 40: Figure 4-H: Video Review Screen

    4 - User Interface Video Review Screen Figure 4-H: Video Review Screen The PrimeSight UNITY 9000 Video Processor User Manual...

  • Page 41: Figure 4-I: Main Setup Menu

    4 - User Interface 4.3.5 Setup Screen The fifth main screen icon is Setup. The menu options branching from the main Setup screen are arranged into six tabbed sections. The first two tabs (Setup and User Configuration) are accessible to the currently logged-in user. The remaining four tabs are accessible only to users with system administrator privileges.

  • Page 42: Figure 4-J: User Configuration Tab

    4 - User Interface The Setup screen’s main Setup tab options are described in Table 4.3.5-A: FUNCTION OPTIONS Turn the display of the text overlay on the image for Patient ID, On Screen Text Date and Time on or off. Note 1 Enter or modify the text for the 2 lines of on-screen notes.

  • Page 43: Figure 4-K: Manage Users Tab

    4 - User Interface Manage Users Tab The Manage Users tab (Figure 4-K) allows a system administrator to create new user accounts, edit existing user accounts (Figure 4-L) and deactivate users. Figure 4-K: Manage Users Tab Figure 4-L: Edit User Screen The PrimeSight UNITY 9000 Video Processor User Manual...

  • Page 44: Figure 4-M: Backup And Restore Tab

    4 - User Interface Backup and Restore Tab The Backup and Restore tab (Figure 4-M) allows a system administrator to manage the backup settings for saving the contents of the archive to external storage or network location. A complete list of backup and restore functions available via this tab can be found in Table 4.3.5-B. Figure 4-M: Backup and Restore Tab Backup and Restore Functions: FUNCTION NAME...

  • Page 45: Figure 4-N: Security Tab

    4 - User Interface Security Tab The Security tab (Figure 4-N) allows a system administrator to control the access security settings for login passwords. A complete list of functions available through this table are shown in Table 4.3.5-C. Figure 4-N: Security Tab Security Functions: FUNCTION NAME FUNCTION &...

  • Page 46: Figure 4-O: Audit Logs

    Audit Logs The Audit Logs tab (Figure 4-O) allows a system administrator to export the selected daily log file for cybersecurity auditing. Figure 4-O: Audit Logs 4.3.6 Help Screen The sixth and final screen icon is Help. The Help screen will display a listing of available help topics and video clips available on the system (Figure 4-P).

  • Page 47: Operation

    5 - Operation 5.0 OPERATION To avoid damage to the Video Processor’s touchscreen display or the attached keyboard, do not press with sharp or pointed objects. SYSTEM START-UP When the unit is powered on, a short beep will sound once. The image and main operating screen will display after the system has completed initialization (Figure 5-A).

  • Page 48: Videoscope Programmable Buttons

    Printer list of supported printers on the Setup tab of the Setup screen. The printer should be connected to one of the USB ports on the rear of the Processor. Contact LABORIE Customer Care with any questions regarding supported printers.

  • Page 49: Adjust The Image Quality

    6 - Adjust the Image Quality ADJUST THE IMAGE QUALITY If this is the first installation and use of the PrimeSight UNITY 9000 Video Processor and peripheral equipment, or if illumination conditions have changed since the previous use, perform the procedures described in this chapter to obtain sharp, clear images.

  • Page 50: Enhance Sub-Menu

    6 - Adjust the Image Quality If the White Balance was not completed successfully, the following message is displayed in the Message Field: WHITE BALANCE FAILED Repeat the above procedures if the White Balance is not completed successfully or as needed. The PrimeSight UNITY 9000 Video Processor stores the White Balance setting in the Videoscope but should be repeated when changing Videoscopes, Video Processors or when viewing conditions change.
  • Page 51 6 - Adjust the Image Quality 6.2.1 Brightness Adjust the Brightness to compensate for a dark image, or at any time using the Brightness slider. The Video Processor stores the Brightness setting for the current user and scope type until it is modified by the user.
  • Page 52 6.2.6 Orientation Adjust the orientation of the image displayed on the monitor using the Orientation function. The image orientation can be changed whenever desired to compensate for the orientation with which the Videoscope is held or to orient the view of the anatomy. The two orientation selections are: •...

  • Page 53: Maintenance And Storage

    Do not attempt to open or modify the Video Processor. Doing so can present a risk of shock to the user or patient. The Video Processor may only be serviced at authorized LABORIE facilities. When the procedure is complete, the endoscopic system must be disconnected and its components reprocessed.

  • Page 54: Routine Periodic Inspection

    7 - Maintenance and Storage ROUTINE PERIODIC INSPECTION Although the PrimeSight UNITY 9000 Video Processor contains no user-serviceable parts (except for fuse replacement), there are periodic inspection procedures that users can perform in addition to those performed before and/or after procedures to assist in detecting problems that could affect the unit’s operation.

  • Page 55: Maintenance And Repair

    Processor has a long and reliable operating life. Defective items must be serviced and repaired exclusively by persons authorized by LABORIE. All repair work shall employ original manufacturer’s parts only.

  • Page 56: Replacing The Fuses

    7 - Maintenance and Storage REPLACING THE FUSES Qualified personnel can replace fuses when necessary. Refer to Figure 7-A to locate the fuse holder. Replace both fuses at the same time (Type T4AH, Slow Blow 4A, 250V, High Breaking Capacity, 5x20 mm size).

  • Page 57: Storage

    • Do not stack or place items on top of the closed LCD monitor. DISPOSAL The equipment should be returned to LABORIE for disposal. Contact your local LABORIE representative or LABORIE Customer Care. The PrimeSight UNITY 9000 Video Processor User Manual...

  • Page 58: Troubleshooting

    Video Processor. It addresses some of the problems that could arise during operation, and suggests corrective actions. If the suggested corrective action does not solve the problem, contact your local distributor or LABORIE Customer Care. If the problem persists even after the corrective action has been taken, or a problem occurs that is not covered in the tables, do not use the Video Processor.
  • Page 59 (Do not look directly into the light guide bundles). If no light is visible, the endoscope should be sent back to LABORIE for repair. Patient material or other Clean the distal tip with an alcohol prep pad substance on the light guides to remove material or stain.
  • Page 60 Processor. Endoscope is damaged Send the endoscope and Processor to LABORIE for repair. Patient debris or other Clean the Distal Tip with an alcohol prep pad material on the Objective to remove material or stain. Excess staining...

  • Page 61: Uvp-9000 Error Messages

    Processor. properly to the Processor The camera head or Contact LABORIE to confirm the camera head endoscope is not compatible or endoscope is compatible with Processor. with the Processor White Balance The scope’s distal head was...

  • Page 62: Warranty And Service

    The warranty defined herein shall apply only to the original buyer. In no event shall LABORIE be liable for anticipated profits, consequential damages or lost time incurred by the buyer with the purchase or use of this equipment.

  • Page 63: Shipping To Laborie Or Distributor

    Observe the following precautions before shipping the Video Processor: The Video Processor or any other LABORIE equipment must be shipped in the original box with the original protective foam caps to prevent damage during shipment. If the original packaging is not available at the time of shipping, contact your regional distributor or LABORIE Customer Care Department to obtain replacement packaging.

  • Page 64: Appendix/Specifications

    Appendix/Specifications APPENDIX/SPECIFICATIONS A-1 SPECIFICATIONS ITEM SPECIFICATION Scanning System 2:1 Interlace Automatic Gain Control Gain Control White Balance Fast Auto White Balance Electronic Shutter Automatic windowed exposure 1/50 second (PAL) or 1/60 second (NTSC) to 1/100,000 seconds Digital Still/Video 500GB Internal Solid State Drive Capture Video Outputs Digital: DisplayPort...

  • Page 65: Electromagnetic Compatibility Declarations

    Appendix/Specifications A-2 ELECTROMAGNETIC COMPATIBILITY DECLARATIONS Use of accessories not specified in this manual or sold by LABORIE may result in increased electromagnetic emissions or decreased immunity of the equipment or system. GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Videoscope with the PrimeSight UNITY 9000 Video Processor [the “System”] is intended for use in the electromagnetic environment specified below.

  • Page 66: Table A-2.2: Electromagnetic Immunity Declaration

    Appendix/Specifications GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Videoscope connected to the PrimeSight UNITY 9000 Video Processor [the “System”] is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is always used in such environments. IEC 60601 test Electromagnetic environment –...

  • Page 67: Table A-2.3: Electromagnetic Immunity Declaration

    Appendix/Specifications GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Videoscope connected to the PrimeSight UNITY 9000 Video Processor [the “System”] is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is always used in such environments. Immunity IEC 60601 Compliance...

  • Page 68: Table A-2.4: Recommended Separation Distances

    Appendix/Specifications RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE SYSTEM The Videoscope connected to the PrimeSight UNITY 9000 Video Processor [the “System”] is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 69: Table A-2.5: Test Specifications For Enclosure Port Immunity

    Appendix/Specifications ENCLOSURE PORT IMMUNITY TO RF WIRELESS COMMUNICATIONS EQUIPMENT The Videoscope connected to the PrimeSight UNITY 9000 Video Processor [the “System”] is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF wireless communications equipment (transmitters) and the System as recommended below according to the maximum output power of the communications equipment.

  • Page 70: Software License Notifications

    A-3 SOFTWARE LICENSE NOTIFICATIONS The UNITY 9000 system incorporates the following open-source and public domain software modules: AudioSwitcher: Sean Chapman (https://audioswit.ch); Microsoft Public License Json.Net: Newtonsoft; Open source under MIT license NLog: Nlog-project.org (Kim Christensen, Julian Verdurman); Open source BSD 3-Clause license Reactive Extensions: .Net Foundation and Contributors;...
  • Page 72 MedPass SAS 40 Ramland Road South 95 bis Boulevard Pereire Orangeburg, NY 10962 USA 75017 Paris - France www.laborie.com ©2018, 2019, 2020 LABORIE. EndoSheath is a registered trademark and PrimeSight is a trademark of LABORIE www.laborie.com 05/20 14513-EN Rev D (04620)

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