Byron LySonix 3000 Operation Manual
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Byron LySonix 3000 Operation Manual

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Byron Medical's
LySonix 3000
®
with PulseSelect
™
Operation
Manual
3000G

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Summary of Contents for Byron LySonix 3000

  • Page 1 Byron Medical’s LySonix 3000 ® with PulseSelect ™ Operation Manual 3000G...

  • Page 2: Table Of Contents

    LySonix 3000 ® with PulseSelect™ Operation Manual TABLE OF CONTENTS 1. SAFETY Summary of Safety Notices (Warnings and Precautions) 2. GENERAL INFORMATION 2.1 Description of the System 2.2 Concept and Principles of Operation 2.3 Functional Components of the System 2.4 Controls and Indicators 2.5 Indications for Use...
  • Page 3 © 2003 by Byron Medical Byron Medical reserves all rights to this document. No part of this manual may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, etc.) without prior written permission of Byron Medical. Requests for permission to reproduce or distribute this document should be addressed to: Byron Medical, Inc.,...
  • Page 4 IS AN ELECTRO-MECHANICAL DEVICE THAT, UNDER CERTAIN CIRCUMSTANCES, COULD PRESENT AN ELECTRICAL SHOCK HAZARD TO THE OPERATOR AND/OR PATIENT. PLEASE READ MANUAL THOROUGHLY AND FOLLOW DIRECTIONS STATED HEREIN TO ASSURE MAXIMUM SAFETY DURING OPERATION. SINCE THE LySonix 3000 ® with PulseSelect ™...
  • Page 5 ™ only in accordance with all of the instructions contained herein. Servicing of the device should only be performed by qualified technicians. Please contact Byron Medical, Inc. There are no service controls accessible to the user. CAUTION: ALL REUSABLE COMPONENTS OF THE DEVICE MUST BE CLEANED AND STERILIZED AND ALL DISPOSABLE COMPONENTS REPLACED BEFORE USING THE DEVICE SYSTEM ON ANOTHER PATIENT.
  • Page 6 THE PROBE THROUGH THE ANATOMIC AREA. WARNING: IF AFTER FUSE REPLACEMENT THE FUSE FAILS WHEN THE GENERATOR IS REACTIVATED, DISCONTINUE USE OF THE DEVICE AND CONTACT BYRON MEDICAL INC, IMMEDIATELY. (800-777-3434 or 520-573-0857) CAUTION: USE ONLY GENUINE REPLACEMENT PARTS FURNISHED BY BYRON MEDICAL INC.
  • Page 7 LySonix 3000 ® with PulseSelect™ Operation Manual WARNING: PLUGGING GENERATOR UNIT INTO SOCKET WHICH SUPPLIES IMPROPER VOLTAGE MAY CAUSE GENERATOR TO MALFUNCTION OR CREATE A SHOCK OR FIRE HAZARD. BE CERTAIN LINE INPUT VOLTAGE SELECTOR SWITCH IS PROPERLY ADJUSTED. WARNING: PROPER SYSTEM GROUNDING CANNOT BE INSURED UNLESS UNIT IS CONNECTED TO A PROPERLY WIRED HOSPITAL GRADE OUTLET.
  • Page 8 EMISSIONS DECREASED IMMUNITY OF THE LYSONIX 3000 ® WITH PULSESELECT ™ . WARNING: THE LYSONIX 3000 ® WITH PULSESELECT ™ SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED USE IS NECESSARY, THE LYSONIX 3000 ®...

  • Page 9: Summary Of Safety Notices (Warnings And Precautions)

    The LySonix 3000 ® with PulseSelect ™ is intended for use in the electromagnetic environment specified below. The customer or the user of the LySonix 3000 ® with PulseSelect ™ should assure that it is used in such an environment.
  • Page 10 The LySonix 3000 ® with PulseSelect ™ is intended for use in the electromagnetic environment specified below. The customer or the user of LySonix 3000 ® with PulseSelect ™ should assure that it is used in such an environment. Compliance...
  • Page 11 (Table 206) The LySonix 3000 ® with PulseSelect ™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LySonix 3000 ® with PulseSelect ™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications LySonix 3000 ®...

  • Page 12: General Information

    PulseSelect ™ uses ultrasound, or sound waves for fragmentation of soft tissues. Unlike standard cutting or Opto-Thermal systems, the LySonix 3000 ® with PulseSelect ™ offers precise control of tissue ablation due to the controlled ultrasound field generated. This precise control allows the surgeon to perform traumatic fragmentation and removal of tumors and other biomass with minimal disturbance to surrounding tissue structure.

  • Page 13: Functional Components Of The System

    LySonix 3000 ® with PulseSelect™ Operation Manual 2.3 Functional Components of the System 2.3.1. Generator The Generator supplies a 22.5 kHz electrical signal to the Handpiece. A feedback circuit tracks frequency changes in the Probe caused by load and temperature changes, and maintains maximum electrical efficiency at all times.
  • Page 14 A separate ON/OFF switch is provided on the Aspiration units to allow independent use and testing of the aspirating feature of the device. The liquid reservoirs recommended by Byron Medical, Inc., prevents liquid from being transported to the pump via the suction line.

  • Page 15: Controls And Indicators

    LySonix 3000 ® with PulseSelect™ Operation Manual 2.4 Controls and Indicators ® ™ The controls and indicators available to the operator of the LySonix 3000 with PulseSelect are as follows: Generator: Main Power ON/OFF Switch (on rear panel) (LED Readout serves as Pilot Light)
  • Page 16 LySonix 3000 ® with PulseSelect™ Operation Manual Figure 1 - Principles of Operation 40-OM-0002 Page 16 of 43 Rev B...
  • Page 17 LySonix 3000 ® with PulseSelect™ Operation Manual Figure 2 - Handpiece-Probe Assembly 40-OM-0002 Page 17 of 43 Rev B...
  • Page 18 LySonix 3000 ® with PulseSelect™ Operation Manual Figure 3 - Front Panel LySonix 3000 ® with PulseSelect ™ 40-OM-0002 Page 18 of 43 Rev B...
  • Page 19 LySonix 3000 ® with PulseSelect™ Operation Manual Figure 4 - Rear Panel MODEL NO. LY-3000 MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11736 40-OM-0002...
  • Page 20 LySonix 3000 ® with PulseSelect™ Operation Manual Figure 5 - Explanation of Symbols 40-OM-0002 Page 20 of 43 Rev B...
  • Page 21 BE sure to REPLACE BOTH fuses. • Reinsert the fuse holder by pressing it into the power connector until it snaps into place. • If the NEW fuse blows, promptly contact Byron Medical, Inc: (800) 777-3434 (520) 573-0857 40-OM-0002...

  • Page 22: Indications For Use

    LySonix 3000 ® with PulseSelect™ Operation Manual Indications for Use 2.5.1 The LySonix 3000 ® with PulseSelect ™ Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of soft tissue in the following surgical specialties: Neurosurgery Gastrointestinal and Affiliated Organ Surgery...
  • Page 23 LySonix 3000 ® with PulseSelect™ Operation Manual 2.6.1 Ultrasonic Generator (Continued) Display Indicators: Ultrasonic Use Time - digital display Ultrasonic Amplitude Level -LED barograph display Mechanical Limit Indicator - LED Electrical Fault Indicator - LED Ultrasonic On Indicator - LED Operating Conditions: Temperature 55-95°F...

  • Page 24: Unpacking Instructions

    Micro Cannula 3.5mm x 20cm Hollow Bullet Tip CAUTION: Use only genuine replacement parts distributed by Byron Medical, Inc. Use of parts furnished by other sources may result in danger or failure and will void any warranty that may apply.

  • Page 25: System Components Preparation

    LySonix 3000 ® with PulseSelect™ Operation Manual 4. OPERATING INSTRUCTIONS 4.1 System Components Preparation CAUTION - All Probes, Handpieces, Handpiece cables, wrenches and accessories are supplied industrially cleaned, but non-sterile. All items intended for use in the sterile field must be cleaned and sterilized as per following instructions before first use and every subsequent use.

  • Page 26: System Assembly

    LySonix 3000 ® with PulseSelect™ Operation Manual System Assembly NOTE: - It is recommended that the Generator Irrigation Unit (if supplied) and Aspiration Unit (if supplied) be positioned on a cart or table outside the sterile field of the Operating Theater. The Generator must be placed on a smooth and level hard surface.
  • Page 27 LySonix 3000 ® with PulseSelect™ Operation Manual 4.2.3.1 Front Driver of Handpiece Thread Probe into Front Driver of Handpiece by hand until tight. Refer to Figure 2. DO NOT force the Probe into the Handpiece threads; it must turn in smoothly all the way until the mating faces touch.

  • Page 28: System Test

    LySonix 3000 ® with PulseSelect™ Operation Manual 5. SYSTEM TEST CAUTION - System test should always be done in advance of prepping patient for surgery to minimize risk to patient in case of system malfunction. 5.1 Turn the Main Switch (rear panel) to the ON position. Fan should start and the Ultrasonic Use Timer LED Display should illuminate.
  • Page 29 LySonix 3000 ® with PulseSelect™ Operation Manual 5.8 Reset Ultrasound Use Timer by pressing Reset Button momentarily. Depress Footswitch to turn on Ultrasound Output Power. Hold distal end of Probe in air and run system for 30 seconds. Unit should run normally with no visual or audible alarms activated. Running unit for 30 seconds checks Probe for defects and proofs all electrical and mechanical connections.

  • Page 30: Instructions For Pulseselect

    LySonix 3000 ® with PulseSelect™ Operation Manual ™ 6. INSTRUCTIONS FOR PULSESELECT FEATURE 6.1 Explanation of Front Panel with PulseSelect ™ Feature Pulse Duration Control Pulse Mode Switch Ultrasonic Enable Switch 6.2 Setup 6.2.1 Verify that the Pulse Mode Switch is in the "CONTINUOUS" position. Verify that the Pulse Duration Control at the front panel is set to the minimum position (fully counter clockwise).

  • Page 31: Selection Of Pulse Duration

    LySonix 3000 ® with PulseSelect™ Operation Manual 6.4 Selection of Pulse Duration 6.4.1 Verify that the Pulse Mode Switch is in the "PULSE" position. 6.4.2 The following figure will present an overview of the available Pulse cycles. The Pulse cycle (also referred to as Duty cycle) is divided into an ON period and an OFF period.

  • Page 32: Pulse Setting

    OFF regardless if the Footswitch is being continuously depressed. 6.5.3 Release the Footswitch, disengage the Ultrasound Enable Switch and place the Handpiece/Probe on a sterile drape. LySonix 3000 ® with PulseSelect ™ SYSTEM IS NOW READY FOR USE.

  • Page 33: System Troubleshooting

    LySonix 3000 ® with PulseSelect™ Operation Manual 7. SYSTEM TROUBLESHOOTING Troubleshooting Guide (Symptom, Possible Cause, and Remedial Action) WARNING - To avoid electric shock, DO NOT remove the case cover from the Generator, Handpiece, irrigation or aspiration pump units. There are no user serviceable parts inside any of these devices.

  • Page 34: Mechanical Limit

    7.3.3 Flip MAIN POWER switch ON and then ULTRASOUND ENABLE switch ON. 7.3.4 Depress Footswitch. If Electrical Fault Alarm activates again, DISCONTINUE USE, REPLACE ENTIRE SYSTEM WITH BACKUP, SET UP AND TEST BACKUP and continue operation. Call Byron Medical Inc., for further instructions. 40-OM-0002 Page 34 of 43...

  • Page 35: System Disassembly And Maintenance

    LySonix 3000 ® with PulseSelect™ Operation Manual 8. SYSTEM DISASSEMBLY AND MAINTENANCE 8.1 Cleaning and Sterilization CAUTION - All Probes, Handpieces, Handpiece Cables, Wrenches and accessories are supplied industrially clean, but non-sterile. All items intended for use in the sterile field must be cleaned and sterilized as per the following instructions before first use and before every subsequent use.
  • Page 36 LySonix 3000 ® with PulseSelect™ Operation Manual CAUTION: - Be certain to clear debris from all Hollow Probes and Handpiece internal passages by brushing. Failure to do so may hinder sterilization of units during autoclaving. CAUTION: - DO NOT use ultrasonic cleaners to clean Handpieces Cables or Probes. Use manual- cleaning techniques only.

  • Page 37: Reuse Life Of Components

    8.3.1 It is highly recommended that the procedures given in this manual for cleaning and ® ™ sterilizing the LySonix 3000 with PulseSelect and related accessories be followed. It is the responsibility of the user of this device or any accessories used with it to validate procedures for cleaning and/or sterilization if they differ from the procedures as outlined in this manual.

  • Page 38: Technical Assistance

    LySonix 3000 ® with PulseSelect™ Operation Manual 8.4 Technical Assistance 8.4.1. Should the user wish further information or instructions regarding any aspect of cleaning or sterilizing procedures, please contact; Byron Medical, Inc. 602 West Rillito Street Tucson, Arizona 85705 (800) 777-3434 (Toll Free)

  • Page 39: Service, Repair And Technical Correspondence

    DAMAGE OR LOSS IN SHIPMENT), contact Byron Medical (800) 777-3434 or (520) 573-0857 to return your unit. A Return Goods Authorization number must be obtained from Byron Medical’s Customer Service Department prior to returning any merchandise. When requesting a Return Goods Authorization number, please follow the return policy as listed under the section labeled POLICY ON RETURNED GOODS.
  • Page 40 LySonix 3000 ® with PulseSelect™ Operation Manual 9.2.2. Repairs must be made by Byron Medical or by an approved authorized agent. Attempting repair without prior authorization nullifies all warranties. 9.3. Modifications 9.3.1. Modifications of any kind are NOT recommended and will void all warranties.
  • Page 41 LySonix 3000 ® with PulseSelect™ Operation Manual 9.6.3. Credit will only be issued if the merchandise is in saleable condition. If the product has been used in surgery, the product must be CLEANED WITH A DISINFECTANT and a written statement confirming such must accompany the product(s).
  • Page 42 Byron Medical’s contracted factory in a way so as in Byron medical’s judgment, to affect stability or reliability, or which has been subjected to misuse, neglect or accident. Shipping this product without proper packaging materials or failing to use proper packing procedures in Byron Medical’s judgment may void this...
  • Page 43 The warranty period for the LySonix® Ultrasonic Surgical System components are as follows: Electrosurgical Generator: -2000 Model One year from date of shipment -3000 Model One year from date of shipment -Refurbished model Six months from date of shipment Operating Handpiece(s) -Standard Six months from date of shipment -Micro FineLine...
  • Page 44 Distributed by: © © © © Byron Medical 602 West Rillito Street Tucson, Arizona 85705 (520) 573-0857 Printed in the USA 40-OM-0002 Page 44 of 43 Rev B...

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