PercuVision DirectVision Technical Reference Manual

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DirectVision
Technical Reference Manual
DirectVision
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TECHNICAL REFERENCE
MANUAL
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Summary of Contents for PercuVision DirectVision

  • Page 1 ® DirectVision Technical Reference Manual DirectVision ® TECHNICAL REFERENCE MANUAL Page i...
  • Page 2 ® DirectVision Technical Reference Manual Page ii...
  • Page 3: Table Of Contents

    ® DirectVision Technical Reference Manual Table of Contents WARNINGS & CAUTIONS ..............1 .............. 1 OCUMENTATION ONVENTIONS ................1 ENERAL ARNINGS ................2 ENERAL AUTIONS PRODUCT DESCRIPTION ..............4 ................4 AMERA ANDPIECE Visual Guide Interface ..............5 Camera Control Unit Interface ............6 Storage During Transportation .............
  • Page 4 ® DirectVision Technical Reference Manual ................31 ONTROL UTTONS CAMERA CONTROL UNIT CALIBRATION PROCEDURES ..... 33 ................... 33 RECONDITIONS ............ 33 AMERA ONTROL RONT ANEL ..................34 ROCEDURES Window Size ................34 Auto Gain Control ................ 35 White Balance Adjustment ............36 Focus ...................
  • Page 5 ® DirectVision Technical Reference Manual Page v...
  • Page 7: Warnings & Cautions

    2. Warning: Federal (USA) Law restricts this device to use by or on the order of a physician. ® 3. Warning: Never look directly at the light emitted from the light source of the camera handpiece or the DirectVision Guide. Damage to eye may result. Page 1 of 49...
  • Page 8: General Cautions

    4. Warning: Never leave the DirectVision® System powered and unattended. Heat from the light source could ignite drapes or other materials. 5. Warning: Do not store or use the DirectVision® System in an environment that contains flammable gases which can result in an explosion.
  • Page 9 ® DirectVision Technical Reference Manual 5. Caution: To prevent damage to the DirectVision® Guide and camera handpiece, always handle with care. Do not drop, crush, cut, or bend any portion of the visual guide beyond a 2” radius. Although the visual guide is flexible, bending beyond the specified radius could cause breakage in the fiber optic bundle, which reduces its useful life.
  • Page 10: Product Description

    CCU. It uses the input control signals to produce streaming video output . The camera handpiece has a locking swing arm to securely couple the camera handpiece to the DirectVision® Guide. The body of the camera handpiece has a Focus Ring, which provides focus for the video image.
  • Page 11: Visual Guide Interface

    ® DirectVision Technical Reference Manual The camera handpiece provides two interfaces: • Visual Guide • CCU Visual Guide Interface The camera handpiece provides alignment and a locking mechanism for the camera handpiece-visual guide interface. When the camera handpiece is not attached to the visual guide, a protection cap is locked into place.
  • Page 12: Camera Control Unit Interface

    ® DirectVision Technical Reference Manual Camera Control Unit Interface A shielded cable attached to the camera connector plug provides the wired electrical interface between the Camera Control Unit (CCU) and the camera handpiece. When plugging the camera connector into the CCU, use the red dots on the camera connector and CCU receptacle to align the recessed connector pins for proper insertion.
  • Page 13: Storage During Transportation

    ® DirectVision Technical Reference Manual Storage During Transportation When the camera handpiece is not in use, 1. The wired attached Plug Cap is locked to the Camera Handpiece Plug. The Plug Cap protects the receded gold connector pins. 2. Protection cap is locked into place. The cap protects the front glass of the LED light source and camera from accumulating dust.
  • Page 14: Camera Control Unit

    ® DirectVision Technical Reference Manual Camera Control Unit The Camera Control Unit (CCU) provides power and control signals to the camera. It converts video signal received from the camera to several standard output video formats for video display. It also provides the power for the LED light source.
  • Page 15: Electronic Interfaces

    ® DirectVision Technical Reference Manual Electronic Interfaces The rear of the CCU provides interfaces for: • Power (IN) 12 VDC • RS 232 (for internal service use) • S-Video (OUT) • Composite Video (OUT) • USB 2.0 (OUT) • FUSE...
  • Page 16: Color Monitor Display

    ® DirectVision Technical Reference Manual Color Monitor Display The color monitor display is an8.4” high resolution LCD monitor. It is mounted on a swivel bracket on the cart which enables easy viewing angle adjustment. The monitor is powered by a 12 VDC medical grade power supply located under the top shelf.
  • Page 17: Control Panel

    ® DirectVision Technical Reference Manual Control Panel The Control Panel is a series of buttons located on the back of the monitor. The following buttons are located on the panel: MENU, DOWN, UP, AUTO and POWER. Monitor Power ON/OFF . To turn the Monitor power ON/OFF, press the Power Button on the back monitor control panel one time.
  • Page 18 ® DirectVision Technical Reference Manual Mainmenu selections for the Display Monitor are: • Video • Audio • Feature Controls Page 12 of 49...
  • Page 19 ® DirectVision Technical Reference Manual The DirectVision System Monitor has four connections: • Power (IN) 12 VDC (used by the System) • VGA Video (IN) (not used by the System) • AV1 (IN) (used by the System) • S-video( IN) (not used by the System) Note: The two monitor connectors used by the DirectVision®System are: Power(DC IN) 12VDC and CVBS.
  • Page 20: Cart

    ® DirectVision Technical Reference Manual Cart The cart is mobile and features a small footprint. It is easily moved from one patient location to another. Workspace The cart features a 17 1/2“ x 19” work space. There are two baskets for temporary storage of catheters, catheter insertion kits, or sterilization trays.
  • Page 21: Power Cord

    ® DirectVision Technical Reference Manual Power Cord The cart has one power cord with a hospital-grade power plug. The power cord is wrapped around two hooks positioned on the cart’s column. The cart must be plugged into a hospital-grade receptacle for proper grounding. Proper grounding is essential for safety and reliable operation.
  • Page 22: Directvision® Guide

    DirectVision Technical Reference Manual DirectVision® Guide The DirectVision® Guide is a fiber optic element which transports light and image information between the distal tip of the fiber optic element and its proximal end. It consists of two fiber channels encased in a sub-millimeter diameter polyimide sleeve.
  • Page 23 ® DirectVision Technical Reference Manual Optical Alignment Dot The visual guide has an alignment “dot” on the female threaded luer. This “dot” assists in locating the 12:00 o’clock position of the visual guide. Page 17 of 49...
  • Page 24: Directvision® Catheter

    DirectVision Technical Reference Manual DirectVision® Catheter The DirectVision® Catheter is a 3-lumen, 100% silicone, Foley catheter that comes either uncoated or with water activated lubricious coating. The first lumen is used for irrigation and drainage. The second lumen is used for balloon inflation and deflation.
  • Page 25: Features

    ® DirectVision Technical Reference Manual Features Balloon The balloon volume is 10cc and is inflated with no more than 10cc of sterile water using a needleless syringe. Angled Tip é The distal tip is angled (as a Coud catheter) to facilitate insertion.
  • Page 26 ® DirectVision Technical Reference Manual Catheter Alignment Dot The alignment “dot” on the catheter manifold is on the same plane as the angled tip. When the “dot” on the manifold is in the 12:00 o’clock position, the catheter tip is in the 12:00 position and the catheter tip is curved up.
  • Page 27: Initial System Assembly

    5/32 Allen wrench (included in accessories box) • 3/32 Hex key (included in accessories box) Note: The DirectVision® Guide is not required for assembly and/or to verify basic operation of the DirectVision® System. Initial Assembly& Test 1. Unpack and inspect shipment.
  • Page 28 ® DirectVision Technical Reference Manual 2. Mount the handle and camera holder to the cart. • Locate two (2) button screws, two (2) locking washers, and a 5/32 Allen wrench in a polybag. • Use the 5/32" Allen Wrench, mounting screws and lock washers to secure the handle to the cart’s handle...
  • Page 29 ® DirectVision Technical Reference Manual • Decide which side to place the camera holder and take out the two screws using the 3/32" hex key. Mount the camera holder by using the screws that were just taken out. 2. Plug in camera handpiece to CCU.
  • Page 30 ® DirectVision Technical Reference Manual • Remove the metal Plug Cap from Camera Handpiece Plug. • Attach the camera handpiece plug to the camera connector receptacle on the CCU’s front panel. Use red dots on the camera connector plug and the Connector Receptacle on theCCU for proper plug alignment.
  • Page 31 ® DirectVision Technical Reference Manual • Remove the Protection Cap from the camera handpiece. 3. Turn on power and verify correct basic operation. • Unwrap the power cord then plug it into a 110/120 VAC wall receptacle. Page 25 of 49...
  • Page 32 ® DirectVision Technical Reference Manual • Turn on the Monitor power by pressing the power button on the back side of the monitor. The monitor should say 'No Signal' and then enter a sleep mode, with the LED showing GREEN, until the CCU is turned on.
  • Page 33 Troubleshooting Section of this Manual if no video image appears on the monitor or no illumination appears at the tip of the camera handpiece. Note: The word PercuVision appears briefly on the monitor, each time the CCU power is turned on. The image will be ®...
  • Page 34 ® DirectVision Technical Reference Manual • Turn the CCU off by pressing the Power OFF Button. LED should turn off. 4. Return the camera handpiece to the camera holder. • Place the plastic Protection Cap on camera handpiece and lock it into position.
  • Page 35 ® DirectVision Technical Reference Manual • Remove the Camera Handpiece Plug from the camera Connector Receptacle on the CCU’s front panel. • Attach Plug Cap to Camera Handpiece Plug. Page 29 of 49...
  • Page 36 Stock the cart baskets with inventory in accordance to Cart Stocking Section of the DirectVision® Instruction Manual. • Place the DirectVision® System in holding area, waiting to be used. Operation of the DirectVision® System has been verified and is now ready for use. Page 30 of 49...
  • Page 37: Monitor Controls

    ® DirectVision Technical Reference Manual Monitor Controls Control Buttons The Control Buttons are located on the back of the monitor and provide control to navigate and select menu entries. To prevent any unwarrented changes in the settings during manipulation of the monitor display, the keys have been locked during the manufacture of the system.
  • Page 38 ® DirectVision Technical Reference Manual Monitor Default Parameter Values Main PercuVision® Default Menu Menu Recommend Contrast Brightness Color Color Tint Sharpness Video Mode Normal Normal Volume Audio Exit Sleep Timer Language English English OSD Control Rotation: Normal Rotation: Normal Feature...
  • Page 39: Camera Control Unit Calibration Procedures

    ® DirectVision Technical Reference Manual Camera Control Unit Calibration Procedures Preconditions The calibration procedures described in this section require the following preconditions: • The cart power cord is plugged into a 110/120 VAC wall receptacle. • The CCU and Display Monitor power switches are in the ON position.
  • Page 40: Procedures

    ® DirectVision Technical Reference Manual Procedures There are four calibration procedures for the CCU: • Window Size • Auto Gain Control • White Balance Adjustment • Focus Each procedure is described in this section. Factory default settings are provided where appropriate.
  • Page 41: Auto Gain Control

    ® DirectVision Technical Reference Manual Default Factory CCU Button Available Choices Setting Window 1 Window 2 Window Size Window 3 Window 4 Default Auto Gain Control The Auto Gain Control Button activates three different factory presets. These presets affect the color and contrast of the image.
  • Page 42: White Balance Adjustment

    To adjust the white balance, proceed as follows: 1. Aim the illuminated tip of the catheter with the DirectVision® Guide inserted into the visual guide lumen or the visual guide tip itself to within approximately 5mm of a white object.
  • Page 43 ® DirectVision Technical Reference Manual White Balancetext string will appear on monitor screen as the CCU begins executing the white balance operation. When the white balance operation is completed, the text string changes to: White Balance OK. The image will change to an accurate white.
  • Page 44: Focus

    DirectVision Technical Reference Manual Focus 1. Point the illuminated tip of DirectVision® Guide to within approximately 5 mm of a white object with text. 2. Observe and assess video image sharpness (e.g. especially vertical and horizontal lines) on display monitor.
  • Page 45: System Maintenance

    1. Open the fuse holder with flathead screwdriver. 2. Turn the fuse holder 90 counter-clockwise. 3. Exchange with proper fuse. 4. Close the fuse holder by turning it 90 clockwise. The DirectVision® System is designed to require no other maintenance. Page 39 of 49...
  • Page 46: Troubleshooting

    ® DirectVision Technical Reference Manual Troubleshooting Step # Problem Potential Solution • Check to see if unit is plugged into a working 100-240 VAC socket • Check different outlet • Check cart bifurcation cord No image on Display • Confirm two power supplies...
  • Page 47 ® DirectVision Technical Reference Manual Step # Problem Potential Solution No image on Display • Confirm Monitor power Monitor supply is plugged into cart bifurcation cord (must remove Power Light on CCU top shelf of cart) "No Signal" display • Verify 12V cable is correctly...
  • Page 48 No light from camera handpiece DirectVision® Guide • Increase the light intensity by Power Light on CCU turning the dial to MAX position on the CCU • Replace DirectVision® Guide • Call Customer Service Page 42 of 49...
  • Page 49 • Cycle Power Switch on CCU • Go to Step 7 • Turn the focus ring on the camera handpiece until the image is in focus • Clean the tip of DirectVision® Blurred image Guide • Replace DirectVision® Guide • Replace camera handpiece •...
  • Page 50 • Re-adjust white balance • Re-adjust Display Monitor Image is too dark settings (must unlock keys- see "Monitor Controls" section) • Replace DirectVision® Guide • Call Customer Service • Re-adjust white balance • Re-adjust monitor settings Inaccurate colors (must unlock keys- see "Monitor Controls"...
  • Page 51 ® DirectVision Technical Reference Manual Step # Problem Potential Solution • Confirm you are using the proper catheter (DirectVision). • Confirm that the visual guide channel is sufficiently irrigated. Cannot Insert • Confirm visual guide is not DirectVision® Guide damaged into catheter •...
  • Page 52: Technical Specifications

    ® DirectVision Technical Reference Manual Technical Specifications Dimension & Weight Camera Control Unit Parameter Value 6.65x2.44x9.72 inches Dimension: (169x62x247mm) (WxHxD) Weight: 2.641lbs (1.2kg) Monitor Parameter Value 8.74 x 6.30 x 1.66 inches Dimension: (222x160x42mm) (WxHxD) Weight: 2.8lbs (1.3 kg approx.)
  • Page 53: Monitor

    ® DirectVision Technical Reference Manual Monitor Parameter Value Monitor Power Supply module: 100-240 VAC, 0.6-0.4A, 47-63Hz Input mains voltage Monitor Power Supply Output 12 VDC, max. 2.5A Monitor Power Consumption 800mA Camera Specifications Parameter Value TV System PAL or NTSC Sensor Size 1/4”...
  • Page 54: Visual Guide Specifications

    ® DirectVision Technical Reference Manual Visual Guide Specifications Parameter Value Field of View Direction of View Optical Resolution 4.9 lp/mm at 5mm distance Operating Environment Camera Control Unit and Camera Handpiece Parameter Value F up to 104 Temperature C up to 40...
  • Page 55: Storage Environment

    ® DirectVision Technical Reference Manual Storage Environment The DirectVision® System and its consumables are to be stored at room temperature in a controlled environment. Spare Parts Camera Control Unit Name Description Main fuse T800, 250V, 5x20mm Warranty, Service & Claims Do not attempt to service this product or you risk voiding the warranty.
  • Page 60 PercuVision® LLC 2030 Dividend Drive Columbus, Ohio 43228 877-913-6333 www.percuvision.com PL000072 Rev 00...

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