LigaSure Service Manual June 2006

Preface The service manual describes the Valleylab LigaSure vessel sealing generator: •

Descriptions of the system, its functions, specifications, and theory of operation

•

Step-by-step instructions on how to set up, calibrate, troubleshoot, and maintain the system

•

Step-by-step instructions on how to replace specific components

•

Parts lists and schematics.

Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Caution Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. Notice Indicates a hazard which may result in product damage. Important Indicates an operating tip or maintenance suggestion.

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Table of Contents Preface ... iii Conventions Used in this Guide ... iii

Chapter 1. Service Personnel Safety Safety Information ...1-2 Warnings, Cautions, and Notices ...1-2 General ...1-2 Active Accessories ...1-3 Fire/Explosion Hazards...1-3 Electric Shock Hazards...1-3 Servicing ...1-4 Calibration ...1-5 Cleaning ...1-5

Chapter 2. Introduction General Description ...2-2 Vessel Sealing ...2-2 Bipolar Operation ...2-3 Instant Response Technology...2-3

Chapter 3. Controls, Indicators, and Receptacles List of Components ...3-2 Front Panel ...3-3 Features ...3-4 Symbols...3-4 Vessel Sealing Controls and Indicators ...3-5 Vessel Sealing Handset Receptacle (purple) ...3-6 Bipolar Controls and Indicators ...3-6 Bipolar Handset Receptacle (blue) ...3-7 Rear Panel ...3-8 Vessel Sealing Footswitch Receptacle (purple) ...3-9 Bipolar Footswitch Receptacle (blue) ...3-9 Option Panel ...3-10

Chapter 4. Technical Specifications Performance Characteristics ...4-2 General ...4-2 Dimensions and Weight ...4-2 Operating Parameters...4-2 Transport and Storage ...4-3 Duty Cycle...4-3 Internal Memory ...4-3 Audio Volume ...4-3 Serial Port ...4-4 RF Activation Port ...4-5

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Expansion Port ... 4-5 Low Frequency (50-60 Hz) Leakage Current (AAMI HF-18-1993) ... 4-6 High Frequency (RF) Leakage Current (IEC 60601-2-2)... 4-6 Input Power ... 4-7 Power Cord Specification ... 4-7 Standards and IEC Classifications ... 4-8 Class I Equipment (IEC 60601-1) ... 4-8 Type CF Equipment (IEC 60601-1)/Defibrillator Proof ... 4-8 Liquid Spillage (IEC 60601-2-2, clause 44.3) ... 4-9 Static Electricity Discharge Interference (IEC 60601-1-2 and IEC 61000-4-2) ... 4-9 Electromagnetic Interference ... 4-9 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ... 4-9 Voltage Transients (Emergency Generator Mains Transfer) ... 4-9 Output Characteristics ... 4-14 Maximum Generator Output ... 4-14 Output Waveform ... 4-15 Output Power vs. Impedance Graphs ... 4-17

Chapter 5. Principles of Operation Block Diagram ... 5-2 Functional Overview ... 5-3 Vessel Sealing ... 5-3 Bipolar Operation ... 5-3 Instant Response Technology ... 5-3 Control Board... 5-4 Microcontrollers ... 5-4 Feedback Microcontroller ... 5-5 Feedback Microcontroller Memory ... 5-5 Shared RAM ... 5-6 I/0 Expansion ... 5-6 Keyboard Interface and Activation Inputs... 5-6 Power Supply Supervisor Circuit ... 5-6 A/D and D/A Conversion ... 5-7 Waveform Generation (T_ON) ... 5-7 T_ON Average Check ... 5-7 Audio Alarm ... 5-8 Serial Interface ... 5-8 Dosage Error Algorithm ... 5-8 Instant Response Algorithm ... 5-9 Front Panel... 5-10 Membrane Keyboard ... 5-10 Power Switch ... 5-10 Display Board ... 5-10 RF Indicator Lamps ... 5-10 LED and Seven-Segment Display Drivers ... 5-11 Regrasp Display ... 5-12

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Mode Select and Power Control Switches ...5-12 Footswitch Board...5-13 Footswitch Decode Circuit ...5-13 Audio Circuit ...5-14 High Voltage (HV) Power Supply Board ...5-15 Power Entry Circuit ...5-15 Auto Mains Switching Circuitry ...5-15 AC/DC Converter ...5-15 DC/DC Switching Regulator...5-16 Thermal Sensing (High Temperature Limit) ...5-17 Low Voltage Power Supply ...5-17 RF Board ...5-18 Operative Modes ...5-19 RF Driver ...5-20 RF Output ...5-20 RF Output Relays ...5-21 EKG Output Relay ...5-21 Primary Sense Circuits ...5-22 Redundant Sense Circuits ...5-23 Single Fault Protection Circuit ...5-24 Heat Sink...5-25 IsoBloc Circuit ...5-25 Integration Functions...5-26 Smart Connector Boards ...5-28

Chapter 6. Setup, Tests, and Adjustments Setting Up the Generator ...6-2 Connecting Bipolar or Macrobipolar Accessories...6-3 Setting the Output for the Selected Mode ...6-4 Activating the Surgical Instrument ...6-4 Periodic Safety Check ...6-5 Recommended Test Equipment ...6-5 Inspecting the Generator and Accessories ...6-6 Equipment ...6-6 Procedure ...6-6 Inspecting Internal Components ...6-8 Equipment ...6-8 Procedure ...6-8 Using the RS-232 Serial Port ...6-9 Equipment ...6-9 Disconnect the Computer from the Generator ...6-11 Testing the Generator...6-11 Confirming Outputs ...6-11 Checking the Vessel Sealing Output ...6-12 Checking the Bipolar Output ...6-12

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Checking Low Frequency Leakage Current and Ground Resistance ... 6-13 Checking High Frequency Leakage Current and Ground Resistance... 6-14 Calibrating the LigaSure Generator ... 6-16 Preparing for Calibration ... 6-17

Chapter 7. Troubleshooting Inspecting the Generator ... 7-2 Inspecting Receptacles ... 7-2 Inspecting Internal Components ... 7-4 Correcting Malfunctions ... 7-5 Responding to System Alarms ... 7-10

Chapter 8. Replacement Procedures Safety ... 8-2 Map of Major Components ... 8-3 Cover... 8-4 Tools Needed ... 8-4 Remove the Cover ... 8-4 Re-install the Cover ... 8-5 High Voltage (HV) Power Supply Board ... 8-5 Tools Needed ... 8-5 Remove the High Voltage Power Supply Board ... 8-5 Install a New HV Power Supply Board ... 8-7 Control Board and Battery ... 8-9 Tools Needed ... 8-9 Remove the Control Board ... 8-9 Replacing the Battery ... 8-11 Tools Needed ... 8-11 Procedure ... 8-11 Install the Control Board ... 8-12 Footswitch Board ... 8-13 Tools Needed ... 8-13 Remove the Footswitch Board ... 8-13 Install a New Footswitch Board ... 8-13 Low Voltage (LV) Power Supply Board ... 8-15 Tools Needed ... 8-15 Remove the Low Voltage (LV) Power Supply Board ... 8-15 Install a New LV power supply board ... 8-16 Front Panel and Display Board ... 8-17 Tools Needed ... 8-17 Remove the front panel ... 8-17 Remove the Display Board ... 8-19 Install the Display Board ... 8-20 Install the Front Panel ... 8-20 Power Switch ... 8-22

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Tools Needed ... 8-22 Remove the Power Switch ... 8-22 Install a New Power Switch ... 8-24 RF Board and Heat Sink ... 8-25 Tools Needed ... 8-25 Remove the RF board ... 8-25 Remove the Heat Sink... 8-28 Install the Heat Sink ... 8-28 Install the RF Board ... 8-29 Power Entry Module ... 8-30 Tools Needed ... 8-30 Remove the Power Entry Module ... 8-30 Install the Power Entry Module ... 8-31 Fuses ... 8-32 Tools Needed ... 8-32 Two Fuses in the Fuse Drawer ... 8-32 Three Fuses on the RF Board ... 8-33 One Fuse on the HV Power Supply Board... 8-33

Chapter 9. Repair Policy Responsibility of the Manufacturer ... 9-2 Returning the Generator for Service ... 9-2 Returning Circuit Boards ... 9-4 Service Centers ... 9-4

Chapter 10. Service Parts Ordering Replacement Parts... 10-2 Map of Major Components ... 10-2 List of Parts ... 10-3 Assembly, Box ... 10-3 Generator Assemblies ... 10-4 Front Panel Assembly ... 10-5 High Voltage Power Supply Board Assembly ... 10-6 RF Board Assembly ... 10-7 Control Board Assembly ... 10-8

Chapter 11. Warranty

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C H APT E R

1

Service Personnel Safety

1

Valleylab stresses safety in the use and servicing of its electrosurgical equipment. This chapter presents the following: • Safety information • Warnings, Cautions, and Notices Refer to the Preface, Conventions Used In This Guide, for further information on Warnings, Cautions, and Notices.

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Safety Information

Safety Information The safe and effective servicing of electrosurgical equipment depends to a large degree on factors solely under the control of the service person. There is no substitute for a properly trained and vigilant service staff.

Warnings, Cautions, and Notices Before servicing the generator, it is important that you read, understand, and follow the instructions supplied with it and with any other equipment used to install, test, adjust, or repair the generator.

General Warning Use the generator only if the self-test has been completed as described. Otherwise, inaccurate power outputs may result. The instrument receptacles on this generator incorporate a smart interface. They operate with Valleylab LigaSure handsets or smart connector adapters exhibiting smart codes.

Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment. These configurations are unstable and/or do not allow for adequate cooling. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as monitors). An activated electrosurgical generator may cause interference with them. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active. Notice If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable. Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage may result.

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Warnings, Cautions, and Notices

Active Accessories Electric Shock Hazard Do not connect wet accessories to the generator. Electric Shock Hazard Ensure that all accessories and adapters are correctly connected and that no metal is exposed.

Caution Connect accessories to the proper receptacle type. In particular, connect bipolar accessories to the bipolar instrument receptacle only. Connect vessel sealing accessories to the LigaSure seal receptacle only. Notice Do not activate the generator until the forceps have made contact with the patient. Product damage may occur.

Fire/Explosion Hazards Warning Danger: Explosion Hazard Do not use the generator in the presence of flammable anesthetics, gases, liquids, or objects. Fire Hazard Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories that are activated or hot from use can cause a fire. Use a holster to hold electrosurgical accessories safely away from personnel and flammable materials. Fire Hazard Do not use extension cords. Fire Hazard For continued protection against fire hazard, replace fuses only with fuses of the same type and rating as the original fuse.

Electric Shock Hazards Warning Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. Do not connect a wet power cord to the generator or to the wall receptacle. Disconnect the power cord before servicing the generator. To allow stored energy to dissipate after power is disconnected, wait at least five minutes before replacing parts. Always turn off and unplug the generator before cleaning. Do not touch any exposed wiring or conductive surfaces while the generator is disassembled and energized. Never wear a grounding strap when working on an energized generator.

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Service Personnel Safety

Warning

Warnings, Cautions, and Notices

Warning When taking measurements or troubleshooting the generator, take appropriate precautions, such as using isolated tools and equipment, using the “one hand rule,’ etc. Potentially lethal AC and DC voltages are present in the AC line circuitry, high voltage DC circuitry, and associated mounting and heat sink hardware described in this manual. They are not isolated from the AC line. Take appropriate precautions when testing and troubleshooting this area of the generator. High frequency, high voltage signals that can cause severe burns are present in the RF output stage described in this manual. Take appropriate precautions when testing and troubleshooting this area of the generator.

Servicing Caution Read all warnings, cautions, and instructions provided with the Valleylab LigaSure electrosurgical generator before servicing. The generator contains electrostatic-sensitive components. When repairing the generator, work at a static-control workstation. Wear a grounding strap when handling electrostatic-sensitive components, except when working on an energized generator. Handle circuit boards by their nonconductive edges. Use an antistatic container for transport of electrostatic-sensitive components and circuit boards.

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Warnings, Cautions, and Notices

Calibration To avoid inadvertent coupling and/or shunting of RF currents around the resistor elements, keep the resistors at least four inches (10.2 cm) away from any metal surface including tabletops and other resistors. This is especially true if several resistors are connected in series or parallel to obtain a specified value. Do not allow the resistor bodies to touch each other. Notice After calibration, the generator will be ready to use only after you initiate the internal self-test by turning the generator off, then on. Calibrate the generator after you install a new battery. Calibration values are lost when the battery is replaced. Calibrate the generator after you install a new control board. Calibrate the generator after you service, repair, or install new components, or after you replace any generator board assembly.

Cleaning Notice Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.

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Service Personnel Safety

Caution

C H APT E R

2

Introduction

2

This chapter introduces the system features: • General description • Vessel sealing • Bipolar operation • Instant Response technology

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General Description

General Description The LigaSure vessel sealing system is an isolated output electrosurgical generator that provides power for vessel sealing and bipolar surgery. It includes the following features: •

LigaSure vessel sealing technology

•

Vessel sealing regrasp indicator alerts you to situations where a full seal cycle has not been achieved

•

Bipolar and macrobipolar modes

•

Instant Response technology

•

Memory button to recall the most recently used intensity and power settings

•

Smart interface for connecting a Valleylab LigaSure handset or smart connector adapter

•

Adjustable volume for the activation tone

•

Handswitch or footswitch activation

•

RF activation port, RS-232 serial port, and expansion port

Vessel Sealing The LigaSure vessel sealing system provides precise energy delivery and electrode pressure to vessels for a controlled time period to achieve a complete and permanent fusion of the vessel lumen. This system works on isolated arteries and veins up to and including 7 mm in diameter and tissue bundles. The system has been optimized to produce minimal sticking, charring, or thermal spread to adjacent tissue.

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Bipolar Operation

Bipolar Operation Two modes are available: •

Bipolar – for most applications. The system provides low voltage to prevent sparking. The power remains constant over a specific range of tissue impedance, allowing a consistent tissue effect.

•

Macrobipolar – for bipolar cutting or rapid coagulation. The system provides higher voltage and greater power than with the bipolar mode.

Instant Response Technology

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Introduction

The LigaSure generator automatically senses tissue impedance and adjusts the output to maintain a consistent effect across different tissue types. This adjustment is based on the power setting and the level of tissue impedance. The system controls maximum output voltage to reduce tissue damage and to minimize sparking.

C H APT E R

3

Controls, Indicators, and Receptacles

1

This chapter describes the front and rear panels, including all controls, indicators, and receptacles. It also describes the fuse drawer and all ports.

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List of Components

List of Components The LigaSure vessel sealing system, a self-contained unit, consists of a main enclosure (cover and base) and power cord. The generator includes the following components: •

Front panel - power switch; regrasp indicator; controls for setting the output power and intensity; a button for recalling the most recently used power and intensity settings; receptacles for connecting electrosurgical accessories; displays for viewing power and intensity control settings; and smart indicators for correct Valleylab LigaSure handset and bipolar adapter use.

•

Rear panel - volume control; two footswitch receptacles; option panel (containing RF activation port, RS-232 serial port, and expansion port); equipotential grounding lug; and power entry module (fuse drawer with two fuses and power cord receptacle).

•

Internal -control (microcontroller) board; display board; smart board; footswitch board; a high voltage power supply; radio frequency (RF) board; and a low voltage power supply.

Refer to Chapter 5, Principles of Operation for details about the interaction of the main components and for circuit board descriptions.

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Front Panel

Front Panel Figure 3-1. Domestic and international front panels Domestic Vessel Sealing Controls and Indicators (page 3-4)

A

B

C

D

Bipolar Controls and Indicators (page 3-6)

E

F

D

G

Controls, Indicators, and Receptacles

International Vessel Sealing Controls and Indicators (page 3-4)

A

B

C

D

LigaSure Vessel Sealing Generator Service Manual

Bipolar Controls and Indicators (page 3-6)

E

F

D

G

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Front Panel

Features These callouts refer to both the domestic and international front panels: A. Power switch

•

To turn on the generator, press (|).

•

To turn off the generator, press (O).

B. Vessel sealing receptacle smart indicator C. Vessel sealing handset receptacle D. Standard and IEC classifications E.

Bipolar receptacle smart indicator

F.

Bipolar handset receptacle

G.

Memory button Pressing this button resets the generator to recall the most recently used intensity and power settings.

For details of the vessel sealing controls and indicators and the bipolar controls and indicators, refer to the following pages in this chapter.

Symbols Several symbols appear on the international front panel: Symbol

Indicates

Vessel Sealing

Regrasp

Macrobipolar

Bipolar

Memory

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Front Panel

Vessel Sealing Controls and Indicators Figure 3-2. Vessel sealing intensity control, activation indicator, and regrasp indicator Vessel Sealing Intensity Display A bar graph indicates the relative seal intensity setting. Seal RF Activation Lamp Illuminates with handswitch or footswitch activation.

Vessel Sealing Intensity Buttons Press Δ to increase the intensity. Press ∇ to decrease the intensity.

Regrasp Indicator

Controls, Indicators, and Receptacles

Illuminates if the tissue is not sealed. This may be due to:

LigaSure Vessel Sealing Generator Service Manual

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Tissue not responding to RF energy

•

Tissue impedance is out of range

•

Seal cycle was interrupted before the cycle was complete

•

Maximum seal cycle time has been reached

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