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Ethicon GYNECARE VERSAPOINT* User Manual

Hysteroscopic bipolar electrosurgical system
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113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 1
Somerville, New Jersey 08876-0151 USA
GYNECARE VERSAPOINT*
Hysteroscopic
Bipolar Electrosurgical System
User Manual
US
GB
113024-G

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  • Page 1 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 1 Somerville, New Jersey 08876-0151 USA GYNECARE VERSAPOINT* Hysteroscopic Bipolar Electrosurgical System User Manual 113024-G...

  • Page 2: Table Of Contents

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 2 TABLE OF CONTENTS SECTION PAGE NTRODUCTION Overview of Endoscopic Surgery ...........1-1 Comparison with Conventional Electrosurgery ......1-1 System Description.................1-2 Indications for Use................1-4 Contraindications for Use ...............1-4 ATIENT AND PERATING AFETY General...................2-1 Fire/Explosion.................2-3 Before Surgery................2-3 EMC Precautions ................2-4 During Surgery ................2-5 Adverse Effects................2-6...

  • Page 3: Introduction

    Section 1 NTRODUCTION This user’s manual will familiarize you with the controls and output functions available from your GYNECARE VERSAPOINT Hysteroscopic generator and instruct you on the proper use of the equipment. OVERVIEW OF ENDOSCOPIC SURGERY An endoscope is an instrument routinely employed to visualize and access the interior of various body cavities for the purposes of both diagnostic and surgical procedures.

  • Page 4: System Description

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 1-2 when using bipolar electrosurgery: orientation of the electrode to tissue, visualization of the working tip, tissue sticking and limited power delivery. One of the additional features of being able to both deliver higher powers through the electrode and the ability to make the active electrode much smaller than the return electrode, allows the system to produce laser-like tissue vaporization by creating a vapor pocket around the active electrode.
  • Page 5 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 1-3 NTRODUCTION 1.1 GYNECARE VERSAPOINT H IGURE YSTEROSCOPIC YSTEM OMPONENTS GYNECARE VERSAPOINT Generator AC Power Input Footswitch Cable (Approx. 3m long) Footswitch Blue Pedal Yellow Pedal Connector Cable (Approx. 3m long) 5Fr Electrode (Approx. 360mm long) Character User Display 10.

  • Page 6: Indications For Use

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 1-4 A sterile electrode is supplied and is discarded after use. It plugs into one end of the GYNECARE VERSAPOINT connector cable which will already have been attached to the GYNECARE VERSAPOINT generator via the front panel socket. The reusable Connector Cable is designed for steam sterilization and may be resterilized and used a maximum of 20 times.

  • Page 7: Patient And Operating Room Safety

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 2-1 Section 2 ATIENT AND PERATING AFETY For the purposes of safety procedures and despite the absence of a conventional return pad, the GYNECARE VERSAPOINT system should still be treated as a high power electrosurgical device. The safe and effective use of electrosurgery depends to a large degree upon factors and variables solely under the control of the operator.
  • Page 8 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 2-2 CAUTION Studies have shown that electrosurgical smoke generated during electrosurgical procedures can be potentially harmful to surgical personnel. These studies recommend using surgical masks or other means of protection. 1,2,3 CAUTION Failure of the HF surgical equipment could result in an unintended increase of output power.

  • Page 9: Fire/Explosion

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 2-3 Servicing CAUTION Electrical Shock Hazard: Do not tamper with the generator housing or attempt to remove the control panel. Refer to authorized personnel for service. NOTE For maintenance of the electrosurgical generator unit refer to the recommended periodic equipment safety checks at Section 12.

  • Page 10: Emc Precautions

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 2-4 CAUTION Read the instructions, warnings and cautions provided with the active accessories before using. WARNING Accessories labeled “SINGLE USE” are single use only. Do not reuse or resterilize. CAUTION Accessories labeled reusable must only be processed according to the recommended procedure and recycled the specific number of uses.

  • Page 11: During Surgery

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 2-5 Generator CAUTION Nonfunction of the generator may cause interruption of surgery; ensure installation procedures are followed and that all connectors are correctly inserted before use. DURING SURGERY Contact With Metal Objects WARNING Use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects.

  • Page 12: Adverse Effects

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 2-6 WARNING Fire Hazard: Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories which are activated or hot from use can cause a fire. Laparoscopy, Endoscopy and Related Procedures WARNING As visualization may be impaired during hysteroscopy for a number of...

  • Page 13: Installation

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 3-1 Section 3 NSTALLATION The electrosurgical generator described in this manual, in conjunction with the available accessories, is designed to be used as a system to provide advanced electrosurgical effects during hysteroscopic surgery including the debulking of intracavitary tissue by vaporization under normal saline irrigation.
  • Page 14 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 3-2 NOTE: Although class A limits have been derived for industrial and commercial establishments, administrations may allow, with whatever additional measures necessary, the installation and use of class A ISM equipment in a domestic establishment or establishment connected directly to domestic electricity power supplies.
  • Page 15 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 3-3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity The GYNECARE VERSAPOINT Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the GYNECARE VERSAPOINT Generator should assure that it is used in such an environment.
  • Page 16 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 3-4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the GYNECARE VERSAPOINT Generator The GYNECARE VERSAPOINT Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the GYNECARE VERSAPOINT Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the GYNECARE VERSAPOINT Generator as recommended below, according to the maximum output power of the communications equipment.

  • Page 17: General Information

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 4-1 Section 4 ENERAL NFORMATION GENERATOR INDICATORS AND DISPLAYS On—Press this button to switch on the generator. When the generator is on, the green light within the on button is illuminated. When the generator is off, it is not available for use. Off—Press this button to switch off the generator.

  • Page 18: Generator Indicators Set-Up And Malfunction Displays

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 4-2 Indicates that the output waveform modality for yellow pedal activation O U T P U T ( Y E L ) can be selected. NOTE Output modality selection can only be performed with an electrode and connector cable attached to the generator.
  • Page 19 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 4-3 Indicates that the footswitch is the F O O T S W I T C H activation source for the system. Activation Status Activate—Using a footswitch, when the generator is activated, the power display of the selected output flashes and an audible tone sounds.

  • Page 20: Generator Connectors And Receptacles

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 4-4 GENERATOR CONNECTORS AND RECEPTACLES FRONT VIEW DISPLAY WINDOW MEMBRANE PANEL CONNECTOR CABLE SOCKET MAINS ON/OFF SWITCH BACK VIEW HEATSINK SERIAL NUMBER LABEL EARTH STUD 10. MAINS POWER INPUT SOCKET 11. FOOTSWITCH SOCKET FENETRE D’AFFICHAGE ENERAL DOUILLE DU CABLE NFORMATION...

  • Page 21: Efore Urgery

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 5-1 Section 5 EFORE URGERY This section describes how to set up the GYNECARE VERSAPOINT system before surgery. You need to perform the following: • Verify the Connector Cable (see Instructions for Use). • Package the connector cable for steam sterilization. •...

  • Page 22: Select The Appropriate Electrode(S) For The Procedure

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 5-2 SELECT THE APPROPRIATE ELECTRODE(S) FOR THE PROCEDURE Electrode Default Settings • For your convenience and to improve safety during use, all electrodes have an internal classification code interrogated by the generator. Default settings and power set adjustment limits are then set appropriately for that particular electrode.

  • Page 23: Uring Urgery

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 6-1 Section 6 URING URGERY This section describes how to use the GYNECARE VERSAPOINT system during surgery. ACTIVE ELECTRODE ACCESSORIES Only Use Approved Electrodes and Connector Cable Electrode and connector cable accessories other than those specifically designed for use with the GYNECARE VERSAPOINT generator must not be used.
  • Page 24 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 6-2 The GYNECARE VERSAPOINT system has an output power capability more equivalent to a monopolar generator than a conventional bipolar generator. Until the surgeon becomes familiar with the characteristics of the system, caution should be used in increasing power output levels above the default settings.

  • Page 25: Set Up The Generator For Surgery

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 6-3 SET UP THE GENERATOR FOR SURGERY What do I need to set up the GYNECARE VERSAPOINT system? As a minimum, you need the following items of the GYNECARE VERSAPOINT system before you can set up for surgery: •...
  • Page 26 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 6-4 Introducing the Hysteroscopic Electrode variants through the Working Channel With the hysteroscope having been inserted into the body cavity, pass the electrode URING URGERY through the working channel ensuring that the working channel tap is in the fully open position prior to introduction.
  • Page 27 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 6-5 Adjustment to output modes: VC1, VC2, VC3, BL1 and BL2 can be made at any time other than while activated or while the generator displays a malfunction. VC1 selection may be inhibited by the electrode classification code. Changing Electrodes During Surgery An electrode can be removed from the connector cable simply by pulling the electrode connector and connector cable receptacle housing apart.

  • Page 28: After Surgery

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 7-1 Section 7 FTER URGERY After surgery, you need to perform the following: • Withdraw the electrode from the hysteroscope. • Disassemble the electrode and connector cable. • Dispose of the SINGLE USE electrode(s). •...
  • Page 29 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 7-2 WARNING Exceeding the recommended number of uses may result in electrical or mechanical failure during use or difficulty when assembling or disassembling the electrode with the connector cable. Accessory Sterilization Procedure Note: The cable is designed for 20 uses only. Each cable should NOT be processed through the steam autoclave more than 20 times.

  • Page 30: Operating Room Troubleshooting

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 8-1 Section 8 PERATING ROUBLESHOOTING Problem Suggestions/Solutions No output power Check cables. Check electrode connection. Request assistance from service engineer. Generator resets Check grounding of generator. during activation Check insulation of connector cable. (Fault 100.10) Check integrity of electrode.

  • Page 31: Performance Specifications

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 9-1 Section 9 ERFORMANCE PECIFICATIONS Specifications are subject to change without notice. In this section, “typical” refers to a specification that is within ±20% of a stated value at room temperature (25˚C/77˚F). Environmental conditions Transport and Storage Ambient temperature: 0 to 50˚C...
  • Page 32 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 9-2 Defibrillator-Proof Type BF equipment with isolated (F) applied part. Each of the electrode terminals of the generator can withstand the effects of defibrillator discharge. Liquid Spillage as per IEC 60601-2-2 The generator enclosure will prevent reasonable amounts of liquid from interfering with the generators safe and satisfactory operation.
  • Page 33 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 9-3 IMPEDANCE (Ω) VERSUS NOMINAL OUTPUT (100W) L DIAGRAMME DE CHARGE A 50% (100W) OWER URVE 1000 DES @ 60W LOAD / OHMS CHARGE/OHMS ( 2 0 0 W ) L U L L O W E R O A D U R V E...

  • Page 34: Error And Fault Codes

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 10-1 Section 10 RROR AND AULT ODES Fault Codes Any fault code is displayed as: “Fault XXX Ref XXX” Faults are transient, non-hazardous events and are recoverable using a generator reset function. Fault conditions can be reset using the mode key. Depressing and releasing the mode key once will initiate user reset, indicated by flashing of the whole fault code on the display.
  • Page 35 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 10-2 Error or Fault Code Ref Description KEY: (f) fatal (r) recoverable Software failure (recoverable) ROM checksum failure (fatal) Non volatile memory failure (r) Memory failure (f) Power generation fault on start up (r) Power generation shutdown fault (f) Unable to drive PWM signal: shorted high (f) Unable to drive PWM signal: shorted low (f)

  • Page 36: Explanation Of Symbols

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 11-1 Section 11 XPLANATION OF YMBOLS Generator back panel Attention, consult accompanying documents. XPLANATION OF YMBOLS Non-ionizing radiation. 11-1 This equipment intentionally emits RF energy during activation. Defibrillator-proof Type BF equipment. This equipment provides a degree of protection against electric shock to TYPE B as defined in IEC 60601-1.
  • Page 37 113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 11-2 This symbol indicates the conductor that may be used to provide potential equalization between the equipment and the installation busbar. SYMBOLS USED ON PRODUCT LABELING Do not reuse Batch number Use by—year and month XPLANATION OF YMBOLS Sterile unless the package is damaged or open.

  • Page 38: Periodic Equipment Safety Checks

    113024G_02.02.10:113024-G English 2/3/10 12:43 PM Page 12-1 Section 12 ERIODIC QUIPMENT AFETY HECKS The manufacturer recommends that the GYNECARE VERSAPOINT electro-surgical generator should be regularly inspected to ensure continued safety of operation throughout its service life. The following safety checks should be performed at least every 12 months by a qualified person who has adequate training, knowledge and practical experience to perform such tests.

  • Page 39: Limited Warranty

    113024G_02.02.10:113024-G English 2/3/10 12:44 PM Page 13-1 Section 13 IMITED ARRANTY The manufacturer warrants the products listed below to be free from defects in material and workmanship under normal user and service for the period(s) set forth below. The manufacturer’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to...
  • Page 40 113024G_02.02.10:113024-G English 2/3/10 12:44 PM Page 13-2 MEDICAL ELECTRICAL EQUIPMENT CLASSIFIED BY UNDERWRITERS LABORATORIES INC. WITH RESPECT TO ELECTRICAL SHOCK, FIRE, MECHANICAL HAZARDS AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH UL60601-1 AND CAN/CSA C22.2 NO. 601.1 21FA E176665 CAUTION USE ONLY THE POWER CORD PROVIDED BY YOUR MISE EN GARDE UTILISER UNIQUEMENT LE CORDON...
  • Page 41 113024G_02.02.10:113024-G English 2/3/10 12:44 PM Page 13-3 O REPORT ANY DEVICE RELATED INCIDENTS OR PROBLEMS (800) 255-2500 (US D PLEASE CONTACT OMESTIC ONLY UTHORIZED UROPEAN EPRESENTATIVE Authorized European Representative: Gyrus Medical Limited Fortran Road St. Mellons Cardiff CF3 OLT United Kingdom Tel: +44 (0) 29 20776300 : +44 (0) 29 20776301 U.S.

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