Valleylab Ligasure Service manual

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Service Manual
LigaSure Vessel Sealing Generator
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This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for servicing the Valleylab LigaSure Vessel Sealing Generator only. Additional information about using the generator is available in the
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
Equipment covered in this manual
LigaSure Vessel Sealing Generator User’s Guide.
Valleylab LigaSure vessel sealing generator - 120V / 240 V
The LigaSure Vessel Sealing Generator Service Manual consists of two parts—the text and a Schematics Supplement.
Valleylab Part Number 1009892 Effective Date May 2008
Trademark acknowledgments
LigaSure and Instant Response are trademarks of Valleylab, Boulder, CO.
Patents
One or more of the following U.S. patents and corresponding foreign patents cover the LigaSure vessel sealing generator and accessories:
5,776,130 6,228,083 6,682,528
5,599,344 6,277,117 6,685,701
5,720,744 6,398,779 6,726,686
5,827,271 6,402,743 6,743,229
6,033,399 6,451,018 D-424,694
6,039,733 6,464,704 D-425,201
6,050,996 6,458,130 D-449,886
6,068,627 6,511,480 D-457,958
6,179,834 6,585,735 D-457,959
Additional patents pending.
Manufactured by
Valleylab, a division of Tyco Healthcare Group LP Boulder, Colorado 80301-3299 USA
European Representative
Tyco Healthcare UK Ltd. Gosport, PO13 0AS, UK
For information call 1-800-255-8522 / 1-303-530-2300
Made in USA Printed in USA
0086
©2008 Valleylab All rights reserved.
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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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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
Expansion Port 4-5
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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 4-9
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)
Voltage Transients (Emergency Generator Mains Transfer) 4-10
Output Characteristics 4-14
Maximum Generator Output 4-14
Output Waveform 4-15
Output Power vs. Impedance Graphs 4-17
4-9
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
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Regrasp Display 5-12 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
Tools Needed 8-22
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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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1Service Personnel Safety
Valleylab stresses safety in the use and servicing of its
electrosurgical equipment. This chapter presents the following:
CHAPTER
1
• 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
Warning
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.
Service Personnel Safety
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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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
Caution
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.
Service Personnel Safety
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2Introduction
CHAPTER
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
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
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.
Bipolar Operation
Introduction
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CHAPTER
1Controls, Indicators, and Receptacles
This chapter describes the front and rear panels, including all
controls, indicators, and receptacles. It also describes the fuse
drawer and all ports.
3
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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
F ig u re 3 -1 .
Domestic and international front panels
Domestic
Front Panel
Vessel Sealing Controls and Indicators (page 3-4)
ABC D EF D G
International
Bipolar Controls and Indicators (page 3-6)
Controls, Indicators,
and Receptacles
Vessel Sealing Controls and Indicators (page 3-4)
ABC D EF DG
Bipolar Controls and Indicators (page 3-6)
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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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F ig u re 3 -2 .
Vessel sealing intensity control, activation indicator, and regrasp indicator
Seal RF Activation Lamp
Illuminates with handswitch or footswitch activation.
Front Panel
Vessel Sealing Controls and Indicators
Vessel Sealing Intensity Display
A bar graph indicates the relative seal intensity setting.
Vessel Sealing Intensity Buttons
Press Δ to increase the intensity. Press to decrease the intensity.
Regrasp Indicator
Illuminates if the tissue is not sealed. This may be due to:
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
Controls, Indicators,
and Receptacles
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Front Panel
Vessel Sealing Handset Receptacle (purple)
You can only connect a LigaSure vessel sealing instrument to this receptacle.
F i gu r e 3 -3 .
Vessel sealing handset receptacle (purple)
F i gu r e 3 -4 .
Bipolar controls and indicators
Macrobipolar RF Activation Lamp
These lamps illuminate with handswitch or footswitch. activation.
Connect a footswitching instrument with a multi-pin connector.
This receptacle is designed to accept a Valleylab Smart Connector.
When the handset is correctly connected, the vessel sealing receptacle indicator illuminates green.
Bipolar Controls and Indicators
Bipolar RF Activation Lamp
These lamps illuminate with handswitch or footswitch activation.
Macrobipolar Power Display
Shows the power setting in Watts for the Macrobipolar mode.
Macrobipolar Power Buttons
Press Δ to increase the power. Press to decrease the power.
Bipolar Power Display
Shows the power setting in Watts for the Bipolar mode.
Bipolar Power Buttons
Press Δ to increase the power. Press to decrease the power.
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Front Panel
Bipolar Handset Receptacle (blue)
You can connect either a footswitching or handswitching bipolar/macrobipolar instrument to this receptacle.
F ig u re 3 -5 .
Bipolar handset receptacle (blue)
Connect a footswitching instrument with a two-pin connector.
or
Connect a handswitching instrument with a three-pin connector.
This receptacle is designed to accept a Valleylab Smart Connector or a Valleylab Smart Connector adapter. If the bipolar instrument you select does not have a Smart Connector, you must use the Valleylab Smart Connector adapter (p/n LS0500).
When the bipolar handset or Valleylab Smart Connector is correctly connected, the bipolar receptacle indicator light illuminates green.
Controls, Indicators,
and Receptacles
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Rear Panel
Rear Panel
F i gu r e 3 -6 .
Rear panel controls and receptacles
Bipolar Footswitch Receptacle (blue band)
Vessel Sealing Footswitch Receptacle
(purple band)
Power Entry Module
Contains a fuse drawer, with two fuses, and a receptacle for connecting the generator power cord.
Speaker
Volume Knob
To increase the volume, turn the knob clockwise.
To decrease the volume, turn it counterclockwise.
You cannot deactivate the activation tone or adjust the Regrasp indicator tone volume.
Handle
Option Panel
Grounding Lug
Use this to connect the generator to earth ground.
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Rear Panel
Vessel Sealing Footswitch Receptacle (purple)
Connect either the two-pedal vessel sealing footswitch or the single-pedal vessel sealing footswitch to this receptacle.
F ig u re 3 -7 .
Vessel sealing footswitch receptacle (purple)
F ig u re 3 -8 .
Bipolar footswitch receptacle (blue)
Two Pedal Footswitch
The connected footswitch activates either vessel sealing or bipolar output for the LigaSure instrument that is connected to the Vessel Sealing Handset receptacle on the front panel.
Single Pedal Footswitch
The connected footswitch activates only the vessel sealing output for the LigaSure instrument that is connected to the Vessel Sealing Handset receptacle on the front panel
Bipolar Footswitch Receptacle (blue)
Connect the bipolar/macrobipolar footswitch when you connect a bipolar footswitching instrument to the generator.
Connect the two-pedal bipolar footswitch to this receptacle.
The connected footswitch activates bipolar or macrobipolar output for the bipolar instrument that is connected to the Bipolar handset receptacle on the front panel.
Controls, Indicators,
and Receptacles
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Rear Panel
F i gu r e 3 -9 .
The option panel
Option Panel
A removable plate on the rear panel covers a serial port, an RF (radio frequency) activation port, and an expansion port. To review the technical specifications for each port, refer to Chapter 4, Technical Specifications.
Expansion Port
Allows a connected device to receive information about RF output from the generator.
RF Activation Port
Allows a connected device to receive information during RF activation of the generator, which can then generate a response. in the device.
Serial Port
Allows connecting a computer to the generator to obtain information using the RS232 communications protocol.
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4Technical Specifications
All specifications are nominal and subject to change without notice.
A specification referred to as “typical” is within ± 20% of a stated
value at room temperature (25° C / 77° F) and a nominal input
CHAPTER
4
power voltage.
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Performance Characteristics
Performance Characteristics
General
Output configuration Isolated output
Cooling Natural convection
Display Two (2) digital seven-segment displays: 1.9 cm
Mounting A Valleylab cart (UC8009) or a stable flat surface
Dimensions and Weight
(0.75 in.) each
Six (6) bar graph displays: 1.0 cm (0.4 in.) each
Width 38.6 cm (15.2 in.)
Depth 40.6 cm (16.0 in.)
Height 12.7 cm (5.0 in.) not including feet
Weight 5.9 kg (13 lbs)
Operating Parameters
Ambient temperature range
Relative humidity 15% to 90%, noncondensing
Atmospheric pressure 700 to 1060 millibars
Warm-up time If transported or stored at temperatures outside the
10° to 40° C (50° to 104° F)
operating temperature range, allow one hour for the generator to reach room temperature before using.
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Transport and Storage
Performance Characteristics
Ambient temperature range
Relative humidity 0% to 95%, noncondensing
Atmospheric pressure 500 to 1060 millibars
Duration of storage If you stored the generator over one year, check the
– 34° to 70° C (– 29° to 158° F)
battery to measure the Vdc minimum and complete a full checkout (including calibration) before use. Contact Valleylab Service for information.
Duty Cycle
Under maximum output settings and rated load conditions (100 ohm load) the generator is suitable for activation times of 10 seconds on, 30 seconds off, for one hour.
Internal Memory
Memory type Nonvolatile, battery-backed RAM
Battery type 3 V lithium button cell
Battery life 5 years
Audio Volume
The stated audio levels are at a distance of one meter. Alarm tones meet the requirements of IEC 60601-2-2.
Technical Specifications
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Performance Characteristics
Activation Tone
Volume (adjustable) 45 dBA minimum
Frequency (nominal) Seal Mode - 440 Hz
Macrobipolar Mode - 520 Hz
Bipolar Mode - 660 Hz
Duration Continuous while the generator is activated.
Seal Complete Tone
Volume (not adjustable)
Frequency 440 Hz
Duration Two short beeps when vessel sealing cycle is
65 dBA minimum
complete
Regrasp Tone
Volume (not adjustable)
Frequency 780 Hz
Duration Four pulsed tones
65 dBA minimum
Alarm Tone
Volume (not adjustable)
65 dBA minimum
Frequency 985 Hz - 780 Hz; 985 Hz nominal
Serial Port
RS-232 compatible; 9600 baud, 8 data bits, 1 stop bit, no parity
A 9-pin connector supporting the following signals:
pin 2 – isolated transmit (serial data output transmit line)
pin 3 – isolated receive (serial data input receive line)
pin 5 – isolated ground (reference for transmit and receive)
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Performance Characteristics
RF Activation Port
The RF activation port is a subminiature phone jack attached to the contacts of a small relay. The contacts close when you activate the generator, but remain open at all other times. This port provides a means to tell other equipment that the generator is producing RF. This may be useful when making EEG or ECG measurements.
Expansion Port
This 15-pin connector supports the following signals:
pin 2 – isolated transmit (serial data output transmit line)
pin 3 – isolated receive (serial data input receive line)
pin 5 – isolated ground (reference for transmit and receive)
pin 7 – regrasp indicator (active high)
pin 8 – RF_ACT indicator (active high when RF is active)
pin 9 – RF disable: input signal that, when activated by an external device, disables active RF output
pin 10 – RF current: output signal proportional to active RF current at 0.8 amp/volt
pin 11 – RF voltage: output signal proportional to active RF voltage at 205 Vrms/volt
Expansion power (from the low voltage power supply):
+ 5 V (pin 6), – 12 V (pin 14), + 12 V (pin 15), and ground (pins 12 & 13)
Rated fuse current:
1 Amp, Slo Blo, @ +5 Vac
0.25 Amp, Slo Blo, @ ±12 Vac
Technical Specifications
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Performance Characteristics
Low Frequency (50-60 Hz) Leakage Current (AAMI HF-18-1993)
Enclosure source current, ground open
Source current, patient leads, all outputs:
Normal polarity, intact ground
Normal polarity, ground open
Reverse polarity, ground open
Sink current at high line, all inputs
< 300 µA
< 10 µA
< 50 µA
< 50 µA
< 10 µA @ 120 V < 50 µA @ 264 V
High Frequency (RF) Leakage Current (IEC 60601-2-2)
Bipolar RF leakage current
69 mA rms
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Input Power
120 Volt 240 Volt
Performance Characteristics
Maximum power at nominal line voltage
Idle: 35 VA
Bipolar: 360 VA
Seal: 480 VA
Full regulation range
90 to 135 Vac
Operating range
85 to 140 Vac
Mains current maximum
Idle: 300 mA
Bipolar: 3.0 A
Seal: 4.0 A
Mains line frequency range (nominal)
50 to 60 Hz
Fuses (2) 4 A, 250 V, 3 AG, SLO-BLO Fuses (2) 4 A, 250 V, 3 AG, SLO-BLO
Power plug
3-prong hospital grade connector
rms
rms
rms
Maximum power at nominal line voltage
Idle: 35 VA
Bipolar: 360 VA
Seal: 480 VA
Full regulation range
186 to 264 Vac
Operating range
170 to 264 Vac
Mains current maximum
Idle: 300 mA
Bipolar: 1.5 A
Seal: 2.0 A
Mains line frequency range (nominal)
50 to 60 Hz
Power plug
3-prong locally approved connector
rms
rms
rms
1
1. The nominal operating power of the LigaSure generator is 480 VA for a maximum operating current of 2.0 A. However, because the unit is fused for 4.0 A, the worst-case power would be 880–960 VA (due to in­put voltages of 220–240 Volts), as indicated by the labeling on the rear panel of the generator.
Power Cord Specification
This unit was equipped from the factory with either a 110VAC hospital grade NEMA 5-15 power cord or a 220VAC CEE7/7 power cord. Should the AC power cord need to be replaced to match another plug configuration, the replacement plug/cable/receptacle configuration must meet or exceed the following specifications:
100-120 VAC
Cable - SJT16/3, IEC color code, maximum length 15 ft (5 m) Plug - minimum 10 A - 125 VAC Unit receptacle - IEC female, minimum 10 A - 125 VAC
Technical Specifications
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Standards and IEC Classifications
220-240 VAC
Cable - H05VVF3G1.0 VDE, maximum length 15’ (5 meters) Plug - minimum 6 A - 250VAC Unit receptacle - IEC female, minimum 6 A - 250VAC
Standards and IEC Classifications
The LigaSure Generator meets all pertinent clauses of IEC 60601-1 second edition and IEC 60601-2-2 third edition.
F
ATTENTION
Consult accompanying documents.
The generator output is floating (isolated) with respect to ground.
DANGER
Explosion risk if used with flammable anesthetics.
To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel.
Non-Ionizing Radiation
Classified with respect to electrical shock, fire, and mechanical hazards only in accordance with UL60601-1 and CAN/CSA C22.2 No. 601.1.
Class I Equipment (IEC 60601-1)
Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they connect to the protective earth conductor.
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Standards and IEC Classifications
Type CF Equipment (IEC 60601-1)/Defibrillator Proof
This generator provides a high degree of protection against electric shock, particularly regarding allowable leakage currents. It is type CF isolated (floating) output and poses no fibrillation danger.
This generator complies with the ANSI/AAMI HF18 specifications for “defibrillator proof” designation and IEC 60601-2-2.
Liquid Spillage (IEC 60601-2-2, clause 44.3)
This generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which, when wet, are likely to affect adversely the safety of the generator.
Static Electricity Discharge Interference (IEC 60601-1-2 and IEC 61000-4-2)
This generator enclosure can withstand an 8 kV electrostatic air discharge.
Electromagnetic Interference
When placed on or beneath an activated Valleylab electrosurgical generator, this generator operates without interference. The generator minimizes electromagnetic interference to video equipment used in the operating room.
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)
This generator complies with the appropriate IEC 60601-1-2 and 60601-2-2 specifications regarding electromagnetic compatibility.
Notice
The LigaSure should not be used adjacent to or stacked with equipment other than specified in the LigaSure User Guide and Service Manual. If adjacent or stacked use is necessary, the LigaSure should be observed to verify normal operation in the configuration in which it will be used.
The LigaSure intentionally applies RF energy for diagnosis or treatment during activation. Observe other electronic medical equipment in the vicinity during the LigaSure activation for any possible adverse electromagnetic effects. Ensure adequate separation of electronic medical equipment based on observed reactions.
The use of accessories, other than specified in the LigaSure User Guide and Service Manual, may result in increased emissions or decreased immunity of the LigaSure.
Technical Specifications
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Standards and IEC Classifications
Voltage Transients (Emergency Generator Mains Transfer)
This generator operates in a safe manner when you transfer between line AC and an emergency generator voltage source.
Guidance and manufacturer's declaration - electromagnetic emissions
The LigaSure is intended for use in the electromagnetic environment specified below. The customer or the user of the LigaSure should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC61000-3-3
Group 1 The LigaSure uses RF energy only for
its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Class A The LigaSure is suitable for use in all
establishments other than domestic and those directly connected to the
Class A
Complies
public low-voltage power supply network that supplies buildings used for domestic purposes.
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Standards and IEC Classifications
Guidance and manufacturer's declaration - electromagnetic immunity
The LigaSure is intended for use in the electromagnetic environment specified below. The customer or the user of the LigaSure should assure that it is used in such an environment.
Immunity test IEC 60601 test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
+/-6 kV contact
+/-2 kV for power
supply lines
+/-1 kV for input/
output lines
+/-1 kV differential
+/-2 kV common
(>95% dip in Ut)
for 0,5 cycle
(>60% dip in Ut)
(>30% dip in Ut)
for 25 cycles
(>95% dip in Ut)
level
+/-8 kV air
mode
mode
<5% Ut
40% Ut
for 5 cycles
70% Ut
<5% Ut
for 5 sec
Compliance level Electromagnetic environment -
guidance
+/-6 kV contact
+/-8 kV air
+/-2 kV for power
supply lines
+/-1 kV for input/
output lines
+/-1 kV differential
mode
+/-2 kV common
mode
<5% Ut
(>95% dip in Ut)
for 0,5 cycle
40% Ut
(>60% dip in Ut)
for 5 cycles
70% Ut
(>30% dip in Ut)
for 25 cycles
<5% Ut
(>95% dip in Ut)
for 5 sec
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the LigaSure requires continued operation during power mains interruptions, it is recommended that the LigaSure be powered from an uninterruptible power supply or a battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
NOTE: Ut is the a.c. mains voltage prior to the application of the test level.
3 A/m 3 A/m Power frequency magnetic fields should be
at levels characteristic of a typical location in a typical commercial or hospital environment.
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Technical Specifications
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Standards and IEC Classifications
Guidance and manufacturer's declaration - electromagnetic immunity
The LigaSure is intended for use in the electromagnetic environment specified below. The customer or the user of the LigaSure should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Portable and mobile RF communications equipment should be used no closer to any part of the LigaSure, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
0.5√P
Conducted RF IEC
61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150KHz to 80MHz
3 V/m
80MHz to 2.5GHz
7 V
7 V/m
d =
d =
0.5√P 80MHz to 800MHzP 800MHz to 2.5GHz
d =
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At a 80MHz and 800MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LigaSure is used exceeds the applicable RF compliance level above, the LigaSure should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the LigaSure.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than 7V/m.
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Standards and IEC Classifications
Recommended separation distances between portable and mobile RF communication equipment and the
LigaSure
The LigaSure is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The Customer or the user of the LigaSure can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LigaSure as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum output
power of transmitter (W)
0.01 0.05 m 0.05 m 0.1 m
0.1 0.16 m 0.16 m 0.32 m
1 0.5 m 0.5 m 1 m
10 1.6 m 1.6 m 3.2 m
150 kHz to 80MHz
0.5√P
d =
80MHz to 800MHz
d = 0.5√P
800MHz to 2.5GHz
d = P
100 5 m 5 m 10 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Technical Specifications
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Output Characteristics
Output Characteristics
Maximum Generator Output
Maximum Open
Circuit Voltage
Mode
Macrobipolar 760 (380) 2.2 95 1.5
Bipolar 335 (168) 2.2 95 1.5
Seal 575 (288) 4.4 150 1.5
Vpp(Vp)
Maximum Short Circuit Current*
A
rms
Maximum Power
Setting
watts
Crest
Factor**
* Open circuit values obtained with a Pearson 411 current measurement with a 1K ohm load attached to the handset.
** Crest factor is an indication of a waveform’s ability to coagulate without a cutting effect.
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F ig u re 4 -1 .
Output voltage at specific intensity settings in the vessel sealing mode
Output Characteristics
Output Waveform
Macrobipolar/Bipolar 473 kHz sinusoid. 100% duty cycle.
Seal 473 kHz sinusoid, pulsed.
Table 4-1
Open Circuit Output Volts Peak (rms)
Mode Generator Intensity Setting — Bars
12345
Seal 51 (36) 82 (58) 115 (81) 139 (98) 151 (107)
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Technical Specifications
Page 46
Output Characteristics
F i gu r e 4 -2 .
Output voltage at specific intensity settings in the macrobipolar and bipolar modes
Table 4-2.
Open Circuit Output Volts Peak (rms)
Mode Generator Power Setting — Watts
10 25 50 75 90 95
Macro Bipolar 133 (94) 201 (142) 293 (207) 355 (251) 354 (250) 287 (203)
Bipolar 51 (36) 82 (58) 115 (81) 139 (98) 151 (107) 266 (110)
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Output Power vs. Impedance Graphs
The following graphs depict the RF output as applied to tissue impedance for generator operative modes of macrobipolar and bipolar outputs.
F ig u re 4 -3 .
Power (in watts) versus impedance (in ohms) in the vessel sealing mode
Output Power vs. Impedance Graphs
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Technical Specifications
Page 48
Output Power vs. Impedance Graphs
F ig u re 4 -4 .
Power (in watts) versus impedance (in ohms) in the macrobipolar mode
F ig u re 4 -5 .
Power (in watts) versus impedance (in ohms) in the bipolar mode
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5Principles of Operation
This chapter provides detailed information about how the LigaSure
vessel sealing generator functions and how the internal
components interact.
CHAPTER
5
The circuitry resides on eight printed circuit boards: the control
board, the display board, the footswitch board, the low voltage
power supply board, the high voltage power supply board, the
Radio Frequency (RF) board, and two smart connector boards.
This chapter includes the following information:
• A block diagram that illustrates how the generator components interconnect
• A general description of how the generator works
• A detailed description of the circuitry for each printed circuit board
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Block Diagram
Block Diagram
F i gu r e 5 -1 .
A diagram of generator component interconnections
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Functional Overview
Functional Overview
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 if the instrument jaws have shorted
out, if the system has reached the maximum seal cycle time, or if the tissue impedance is out of range
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.
Bipolar Operation
Two modes are available:
Bipolar – for most applications. The LigaSure bipolar system provides tissue
dessication with low voltage to prevent sparking. The power remains constant over a specific range of tissue impedance, allowing a consistent tissue effect.
Principles of Operation
Macrobipolar – for bipolar cutting or rapid coagulation. The system provides
higher voltage and greater power than with the bipolar mode.
Instant Response Technology
The LigaSure generator automatically senses tissue impedance and adjusts the output voltage 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.
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Control Board
Control Board
Refer to Chapter 10, Service Parts, for components and the Schematics Supplement for system schematics.
The control board contains the circuitry that controls the generator, including the indicators and switches on the display board and the Radio Frequency (RF) output stage on the RF board. Firmware on the control board performs many diagnostic and initialization routines, and reports errors as alarm numbers on the front panel.
The control board interfaces with the RF board through a 96-pin card edge connector. It interfaces with the display board through a 64-pin ribbon cable.
Microcontrollers
Two microcontrollers on the control board control the LigaSure system. These microcontrollers communicate with each other through a shared random access memory (RAM). The main microcontroller (U5) performs all system functions except the feedback control of the generator RF output. The feedback microcontroller (U11), which is a separate, dedicated microcontroller, controls the real-time-critical feedback control of the generator RF output. All system analog signals are available to these microcontrollers.
A third microcontroller (U9) functions as an application-specific integrated circuit, or ASIC. It generates the RF drive waveforms (T_ON\) for the RF output stage.
Main Microcontroller
The main microcontroller (U5) is an 80C562 that incorporates an 8-input multiplexed 8-bit A/D converter. The main microcontroller is responsible for overall system control. It monitors all dosage error functions and safety circuits. It implements the user interface, including activation control. It is primarily responsible for these functions:
Segment display drivers and LED update
Power control buttons, mode buttons, and the activation interface
Serial port interface
Alarm handling
Audio control
Memory control and storage (system alarms with time stamps; calibration values)
Real-time clock control and interface
Internal self-tests
Communicating with the feedback microcontroller
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Control Board
Main Microcontroller Memory
An ST Microelectronics PSD835G2 programmable systems device (U3) provides program memory (512K x 8 external Flash Memory) and data memory (2K x 8 external battery-backed static RAM) for the main microcontroller. Additional data memory is available from these sources:
256 x 8 microcontroller internal RAM
4K x 8 external static RAM (U4) shared with the feedback microcontroller
Battery-Backed RAM
A socket on the control board contains a 3.0 V lithium button cell battery (BT1). This battery provides backup power for the 2K x 8 external RAM on the PSD835G2 device (U3) used by the main microcontroller. The battery-backed RAM stores calibration constants, last setup parameters, and temporary data.
Feedback Microcontroller
The feedback microcontroller (U11), like the main microcontroller, is an 80C562. It receives commands from the main microcontroller and, when the generator is activated, establishes the appropriate relay closures and activates RF output. It continually adjusts the output signal of the generator by controlling the high voltage DC power supply and the RF clock circuitry. It is primarily responsible for these functions:
Principles of Operation
T_ON waveform control
Constant voltage, current, and power feedback control
ECON initialization
Real-time information update (actual voltage, current, power, impedance, effect mode)
Memory tests
Communicating with the main microcontroller
Feedback Microcontroller Memory
An ST Microelectronics PSD835G2 programmable systems device (U3) provides program memory (512K x 8 external Flash Memory) and data memory (2K x 8 external static RAM) for the feedback microcontroller. Additional data memory is available from these sources:
256K x 8 microcontroller internal RAM
4K x 8 external static RAM (U4) shared with the main microcontroller
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Control Board
Shared RAM
An IDT 713425A device (U4) with semaphore flags provides the 4K x 8 external shared static RAM. The shared RAM allows the main microcontroller (U5) and the feedback microcontroller (U11) to share common variables. It functions as a communications interface between the main and feedback microcontrollers. It also provides additional general-purpose RAM to these microcontrollers.
I/0 Expansion
Three devices provide input/output (I/O) expansion capabilities:
One ST Microelectronics PSD835G2 programmable systems device (U6)
One ST Microelectronics PSD835G2 programmable systems device (U3)
One 82C55 expansion port (U2)
The ST Microelectronics PSD835G2 incorporates 52 individually programmable I/O pins divided into 6 ports of 8-bits each and 1 port of 4-bits. Of the general I/O pins, 24 can alternatively be utilized for 24 PLD outputs. The PSD835G2 also contains 512K x 8 Main Flash Memory, 32K x 8 Boot Flash Memory, 2K x 8 of SRAM, and a power management unit for battery backup. The power management unit for battery backup is not used by the Feedback microcontroller. The I/O expansion capabilities of the Feedback PSD835G2 has a built-in IEEE
1149.1 compliant JTAG serial port to allow full-chip in-System Programmability (ISP). The Main PSD835G2 is #1 on the JTAG chain and the Feedback PSD835G2 with the exception that the 512K x 8 Flash Memory for the Main PSD835G2 is accessed in a bank switching methodology and the I/O expansion capabilities are configured as outputs for lamp control, keyboard scanning, and chip selects.
The 82C55 is a generic I/O expander which incorporates 24 I/O pins divided into 3 ports of 8-bits each. The 82C55 is configured as all inputs, and is used to read the keyboard, keying signals, accessory switches, and system status flags.
Keyboard Interface and Activation Inputs
The keyboard interface is a simple row and column matrix between three bank select output lines (BANK0–BANK2) on port A of the PSD835G2 (U3). The main microcontroller and eight keyboard (KBD_D0–KBD_D7) input lines on port A of the expansion port 82C55 (U2) use this interface.
Port B of the expansion port 82C55 reads activation inputs from the IsoBloc decoding circuits on the RF board.
Power Supply Supervisor Circuit
The power supply supervisor circuit (U14), a MAX691, generates a Reset signal and a Reset\ signal for the main microcontroller (U5) if the power supply voltage to the control board drops below 4.65 V. It also generates a voltage sensitive chip select for the PSD835G2 (U6) and the PSD835G2 (U3). The low voltage threshold (4.65 V) places U3 and U6 in sleep mode and disables the 2K x 8 external static RAM.
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Control Board
A/D and D/A Conversion
Each 80C562 microcontroller (U5 and U11) contains an 8-channel multiplexed 8­bit analog-to-digital (A/D) converter. Incorporating fixed gain control in the sense circuits on the RF board and prescaling based on the expected input voltage or current values enhance the resolution of voltage and current sense inputs.
An MP7226 quad digital-to analog (D/A) converter (U15) provides 4-channel 8­bit D/A capabilities for the feedback microcontroller to output 0 to 5 Vdc analog voltages.
Waveform Generation (T_ON)
A dedicated 89C54 microcontroller (U9) generates the RF drive waveforms (T_ON\) for the RF output amplifier on the RF board. The microcontroller functions as an application-specific integrated circuit (ASIC), performing an endless series of repetitive tasks while enabled.
The feedback microcontroller (U11) holds the T_ON microcontroller (U9) in a reset state until the feedback microcontroller detects a valid activation request. After validating the request, the feedback microcontroller releases the T_ON microcontroller from reset and communicates a 4-bit code - 0 - that represents the generator mode to be activated.
Principles of Operation
The code generates a unique waveform pattern to be delivered to the RF output stage of the generator. The T_ON microcontroller reads and evaluates the code and, if the code value is acceptable, repetitively generates the appropriate waveform until the activation request ends. After the request ends, the feedback microcontroller places the T_ON microcontroller back into reset.
If the code received by the T_ON microcontroller is not valid, the internal program sets an error flag, deactivates all output signals, and remains in an error state until the user resets the system.
T_ON Average Check
A capacitor filters the T_ON waveform generator output, returning it to the main microcontroller as a DC voltage value called T_ON average. Each distinct output mode of the T_ON waveform generator produces a different T_ON average. The main microcontroller continually checks the T_ON average for compliance with the calibrated value to ensure that the T_ON waveform generator is operating properly.
The T_ON average signal rests at 5 V when the generator is not activated and drops to the calibrated value when activation occurs. The main microcontroller checks to make sure the T_ON average signal is within ± 15 counts of the calibrated value.
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Control Board
Audio Alarm
The audio alarm circuit resides on the footswitch board. Both software and hardware control the audio alarm.
The feedback microcontroller, in response to activation inputs, alarms, and
power-up, writes to a digital-to-analog converter (DAC) chip, U15, which generates an analog control signal, V_FREQ. This signal provides software control for the audio alarm. The V_FREQ signal connects from the control board to the RF board through the 96-pin connector, and then from the RF board to the footswitch board through the 20-pin footswitch ribbon connector.
The RF_TONE\ signal provides hardware control. RF sensing circuitry on the
RF board generates the RF_TONE\ signal in the RF output stage.
Serial Interface
The RS-232 serial port is a software-polled interface to the main microcontroller (U5). You can use it for diagnostics and calibration. Transmission and receipt of command strings do not stop real time processing, except as single characters are read from or written to the serial port. The serial port configuration follows:
9600 baud
8 data bits
1 stop bit
no parity
This timing is derived from the main microcontroller oscillator frequency of
11.0592 MHz.
The control board serial port signals connect to the RF board through the 96-pin connector. The signals then connect to the 9-pin serial port connector on the RF board.
Dosage Error Algorithm
The basis of the dosage error algorithm for the closed loop modes (bipolar and seal) is a comparison between two microcontroller/sensor sets:
Main microcontroller, current and voltage sensors
Feedback microcontroller, current and voltage sensors
While the feedback microcontroller operates the generator, the master microcontroller continuously monitors generator operation, calculating and checking several values:
Voltage and current input to the microcontrollers
High voltage control signal
High voltage sense signal
Desired value (entered at the front panel) at the main microcontroller
Desired value (entered at the front panel) at the feedback microcontroller
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Control Board
The master microcontroller, using the dosage error algorithm, checks to make sure the feedback microcontroller is operating the generator within specific parameters:
During idle, the main sensors receive less than 50% of full scale.
The high voltage (HV) power supply board control signal is greater than 90% and the V/I signals are less than 10% of full scale.
The HV power supply and the HV sense signals are within one volt of each other.
The power readings at the main and feedback microcontrollers do not differ by 50 watts or more.
Sensors connected to the main microcontroller are not stuck at 100% of full scale.
Desired power at the main and feedback microcontrollers are the same.
Actual power is below the error threshold as defined by IEC 60601-2-2, Dosage Error Limits.
If the algorithm detects that the generator exceeds one or more these parameters, it signals an error condition. The system displays an error message and shuts down all generator output.
Instant Response Algorithm
This algorithm controls the current, power, and voltage adjustments for all modes.
Controlling the maximum output voltage reduces high frequency leakage, reduces video interference, and minimizes sparking. At low impedances, keeping the current constant protects output circuitry. At high impedances, keeping the voltage constant limits arcing and electro-magnetic interference.
Constant Current
The algorithm holds output current constant according to this equation:
I = (P/R) ˆ(1/2)
where I is the output current, P is the power set by the user, and R is the constant current to constant power impedance switchpoint.
Principles of Operation
Constant Power
The algorithm maintains the power set by the user.
Constant voltage
The algorithm controls the output voltage according to the following equation:
V = (P*R) ˆ(1/2)
where V is the output voltage, P is the power set by the user, and R is the constant power to constant voltage impedance switchpoint. In some high impedance conditions, the algorithm modifies this equation to reduce voltage more rapidly.
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Front Panel
Front Panel
The front panel consists of an injection molded plastic bezel with a membrane keyboard, power switch, and seal and bipolar smart receptacles. These front panel components connect to the display board and the RF board.
Membrane Keyboard
A high strength adhesive attaches the membrane keyboard to the bezel. The keyboard is not removable. The membrane contains 16 metal dome push-button switches. Six of these switches control the up and down sequencing of the power seven-segment and bar lamp light-emitting diodes (LEDs). One switch controls the Memory function, which stores previous settings.
The membrane also contains three illumination window LEDs, one for each RF activation mode. A 12-pin flat ribbon cable connects the membrane keyboard switches and LEDs to the display board.
Power Switch
A double pole single throw switch snaps into the front of the bezel. This switch connects the AC mains to supply power to the generator.
Display Board
Refer to Chapter 10, Service Parts, for components and the Schematics Supplement for system schematics.
The display board resides in the front panel assembly. It contains RF indicator lamps, seven-segment LED power setting displays, seal bar lamp setting displays, and a regrasp indicator lamp. The display board switch circuitry includes the LED and lamp driver circuitry, power selection switches, mode selection switches, and the smart switch LED driver circuit.
RF Indicator Lamps
The RF indicator lamps illuminate during RF activation to indicate the presence of RF power. Two incandescent bulbs illuminate each of the three indicator bars (seal, bipolar, and macrobipolar) on the front panel.
LP11 and LP12 illuminate the blue bipolar bar, indicating bipolar activation.
LP7 and LP8 illuminate the light blue macrobipolar bar, indicating cut
activation.
LP3 and LP4 illuminate the blue seal bar, indicating seal activation.
The BIP_LMP, MACRO_LMP, and VS_LMP signals control the RF indicator lamps. These signals originate from port A of the main microcontroller programmable peripheral (U3) on the control board.
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Display Board
Q1 through Q4 MOSFETS turn the RF indicator lamps on and off. Resistors R4, R5, R9, R10, R13, and R14 set the amount of current flowing through the lamps when they are turned on. The value of these resistors varies for each indicator bar, depending on the color of the bar, to make the different colors of the bars illuminate with equal intensities.
LED and Seven-Segment Display Drivers
This circuit contains two display drivers: the LEDs and the seven-segment displays. The bar lamp LEDs indicate the seal intensity. The seven-segment displays indicate the bipolar and macrobipolar power settings.
Each display driver (U10 and U11) can drive up to eight banks of eight LEDs by multiplexing the time at which it turns on each bank and controlling how long the bank remains on. Wiring the banks together increases the time that a group of LEDs can remain on, effectively increasing the brightness of that group.
U10 drives the discrete bicolor LEDs. These include the red and green indicators for the smart connectors in the bipolar and seal modes. The anode of each mode selection LED connects to driver U10. Using pairs of the driver digit lines makes the effective duty ratio for these LEDs 1/4.
U11 drives the seven-segment displays that indicate power settings. U5 and U6 indicate the bipolar power setting; U2 and U3 indicate the macrobipolar power setting; and U1, U4, U7, U8, and U9 indicate the seal intensity bar lamp setting. Seal bar lamp U12 illuminates yellow when you turn the power on and the system completes its self-diagnostic test successfully. The yellow lamp setting corresponds to a default seal power setting of zero output. The anodes of these displays each connect to only one digit line of the driver. The effective duty cycle is 1/8 for each seven-segment display.
Principles of Operation
Some filtering components are associated with U10 and U11. Bypass capacitors C3, C4, C5, C6, C8, and C9 connect between + 5V and DGND. C3, C5, C6, and C8 have a relatively small capacitance value (0.1 µF or less) to filter higher frequency noise. C4 and C9 have a relatively large capacitance value of 47 µF to supply the large spikes of current for the LEDs generated by the multiplexing action of the drivers, which typically occurs at 250 Hz.
Resistor components R16 through R22 and R31 reduce the input impedance of the display driver inputs as seen by the main microcontroller on the control board. This rounds off the edges of these digital signals, reducing high frequency emissions. The lower impedance also reduces the susceptibility of the circuit to noise from other circuits.
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Display Board
Regrasp Display
Q4 drives the discrete LP1 regrasp lamp on and off with seal mode operation only. When Q4 is on, resistor R8 controls lamp LP1 current to control lamp brightness. When received from the control board, a positive TTL level signal activates this display.
Mode Select and Power Control Switches
The mode select and power control switches operate in an 8-bit control format:
Bits No. of Wires Purpose
6 2, in pairs 1 pair for each of three operative
modes: seal, bipolar, and macrobipolar
1 1 memory recall function
1 1 BANK_0, enables the keyboard
membrane
The main microcontroller selects the BANK_0 enable switch through this path:
Port A (on the control board programmable peripheral, U3) through Connector J1 to BANK_0 enable switch
When turned on, MOSFET Q5 activates the keyboard switches.
Command control signals KBD-01 through KBD-06, originating in the control board, choose the up and down power select bit lines:
Command Signals Function
KBD-01 and 02 Up/Down seal intensity select
KBD-03 and 04 Up/Down macrobipolar power select
KBD-05 and 06 Up/Down bipolar power select
KBD-00 Memory recall select
To read the switches, the main microcontroller enables BANK_0 and reads the state of the keyboard switch return lines, KBD-00 through KBD-06 through the following path:
BANK_0 enable switch through Connector J1 to Port A (on the control board I/O expansion port, U2)
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Footswitch Board
Footswitch Board
Refer to Chapter 10, Service Parts, for components and the Schematics Supplement for system schematics.
The footswitch board resides inside the rear panel. It contains decode circuitry for accepting and decoding footswitch inputs and an audio circuit for announcing generator activation and various alarm tones. The footswitch board interfaces with the RF board.
Footswitch Decode Circuit
Two bipolar footswitch connectors, mounted on the footswitch board, extend through the rear panel. These footswitch connectors (J2 and J4) accept bipolar and seal footswitch plugs and provide footswitching capability to activate and deliver RF energy to the instrument receptacles on the front panel. The bipolar footswitch connector (J2), color coded blue, mates with the chassis rear panel receptacle highlighted by a blue annular ring. This dual pedal footswitch, connected to J2, allows the delivery of macrobipolar and bipolar RF energy for tissue cut and coagulation.
The bipolar footswitch connector (J4), color coded purple, mates with the chassis rear panel receptacle highlighted by a purple annular ring. This dual pedal footswitch, connected to J4, allows the delivery of seal and bipolar RF energy for tissue sealing and coagulation.
Principles of Operation
As required by the IEC, the footswitch circuit is isolated from patient connected and ground referenced circuits and is able to withstand a potential of 500 Vrms (50/60 Hz). To obtain this isolation, an isolated power supply (U3) powers the footswitch connected circuitry. The isolated power supply, an HPR-107, operates from the ground referenced +12 V power supply and supplies an isolated 12 volts.
Resistors R12 and R27 form a voltage divider that yields a reference voltage signal (Vref2) of approximately 6 volts. This reference voltage goes to the noninverting inputs of comparators U1A, U1B, U2A, U2B, and U6A.
The common terminal of each footswitch connects to the +12 V isolated power source. Footswitch activation applies +12 V to a resistor divider network. The values of the resistors in the input divider combine to provide a switching threshold of approximately 750 ohms, dividing the +12 V signal. The divided voltage then goes to the inverting input of one of the five comparators (U1A, U1B, U2A, U2B, or U6A). When the voltage at the inverting input exceeds the voltage at the noninverting input, the open collector output of the comparator turns on, causing current to flow in the LED of the corresponding optoisolator. This current generates an infrared (IR) beam that causes an associated photo­transistor to conduct. The collectors of the transistors connect to input pins of an I/O port on the microcontroller where they activate the desired mode of operation.
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Footswitch Board
Audio Circuit
The audio system consists of an audio oscillator, tone control signals, a volume control potentiometer, an audio amplifier, and a speaker.
The audio circuit sounds a tone when RF output is active and a different tone when alarm conditions occur. A potentiometer (R19) allows you to adjust – but not turn off entirely – the volume of RF output activation tones. You cannot adjust the volume of the alarm tone.
When pulled low, the RF_TONE\ signal turns on diode D1 and actively shuts off MOSFET Q1 to enable the audio oscillator, U4.
The feedback microcontroller supplies an analog level control signal, V_FREQ, that determines the output frequency at U4, a voltage controlled oscillator. V_FREQ varies in amplitude to provide the appropriate audio tone.
Normal activation tones are mode dependent and have the following typical operating frequencies:
Mode Frequency (Hz)
Seal 440
Macrobipolar 520
Bipolar 660
Audio IC U5 amplifies the activation tone signal from U4. Potentiometer R19 allows audio volume control.
The ALARM signal interrupts the activation tone and resets the volume to a fixed level. U7A and U7B are configured in an exclusive OR arrangement that is interactive with volume potentiometer R19.
Under normal operating conditions, the ALARM signal is low, the U7A output floats, and the U7B output transistor remains on. The output of U7B creates a voltage divider through R5, R19 (the volume control potentiometer), and R6 to attenuate the audio signal to levels acceptable for input to the audio amplifier. R6 determines the maximum audio volume and R5 determines the minimum audio volume. R35 determines the audio alert volume level. R7 provides an alternate audio signal path in the event of an open volume control potentiometer.
When the ALARM signal is high, the U7A output transistor is on and the output of U7B floats. The U7A output transistor, when on, pulls R35 to ground and creates a fixed voltage divider with R6 to produce the alarm volume level at the input to audio amplifier U5. Meanwhile, the output of U7A floats, thus removing the variable resistor divider from the circuit. In this case, the volume control potentiometer becomes a small resistance in series with the high impedance input from the audio amplifier, negating the effect of the volume setting.
Audio amplifier U5 and speaker SP1 constitute the final stage in the audio system. C13 AC couples the audio signal to the amplifier. When its gain select pins float, the voltage gain of U5 is about 20. Because the U5 output signal is internally biased to Vcc/2, it is necessary to AC couple the speaker through C16 to prevent the amplifier from DC biasing the speaker.
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High Voltage (HV) Power Supply Board
Warning
Potentially lethal AC and DC voltages are present in the AC line circuitry and high voltage DC circuitry described in this manual. Take appropriate precautions when testing and troubleshooting this area of the generator.
The high voltage power supply contains the power entry circuitry, auto mains switching circuitry, AC/DC conversion circuitry, and a DC/DC switching regulator.
Power Entry Circuit
The power entry circuit consists of an integral three wire power cord receptacle, fuse drawer, EMI filter, and a separate power switch. The power switch resides on the front panel; the receptacle/filter, on the rear panel of the generator. You can change AC line fuses, located in the receptacle/filter, from the rear of the generator.
High Voltage (HV) Power Supply Board
Principles of Operation
Auto Mains Switching Circuitry
The auto mains switching circuit detects the AC line voltage level and controls the triac (D1). This triac controls the topology of the AC/DC converter. For 120 Vac operation, the triac is on, which connects the AC neutral to the center of the AC/ DC converter capacitor network (C17 and C25). In this configuration, the circuit acts as a doubler using the right half of the bridge rectifier (CR3). For 240 Vac operation, the triac is off and CR3 becomes as a full wave rectifier.
The control IC (U5) functions as follows: The series circuit (CR7, R48, R49, and C28) provides power for U5. Pin 1 (Vss) is a shunt regulator that provides a –9 V (nominal) output. The divider (R40 and R41) measures the input line voltage. Since the voltage at pin 8 varies with the line, it can sense the line voltage zero crossing as well as the peak voltage. Pins 2 and 3 are inputs to an oscillator used for triac triggering timing. R42 and C26 set the oscillator frequency. Pin 7connects to Vss, which places the circuit in the fail-safe mode. Thus, once the circuit enters full bridge mode, it remains in that mode until the user recycles input power. A power dropout cannot cause the circuit to accidentally act as a doubler when the generator receives the higher input voltage range.
AC/DC Converter
The AC/DC converter uses CR3 as either a doubler or a full wave rectifier, depending on the input voltage. In either case, an unregulated nominal 340 Vdc is provided to the DC/DC switching regulator. Thermistors R28 and R29 provide inrush current limiting, and fuse F1 provides protection against faults in the DC/ DC switcher.
Capacitors C17 and C25 function as an energy storage reservoir for the DC/DC switcher. C23 and C24 function as a high frequency bypass filter. Bleeder resistors R46 and R47 discharge the capacitors when the user disconnects the AC line or turns off the power switch.
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High Voltage (HV) Power Supply Board
DC/DC Switching Regulator
The DC/DC switching regulator is a buck derived, pulse width modulated (PWM) system. It is an isolated, fixed frequency, full bridge forward converter. The PWM IC (U4) functions in the voltage mode. The output of the regulator is adjustable from approximately 0 to 120 Vdc.
The regulated power supply incorporates a full H bridge and consists of four power MOSFETs (Q3, Q4, Q5, and Q6) that operate at AC line potential. Transistors Q3 and Q4 are on while Q5 and Q6 are off, and the reverse. In this manner, power signals to the power transformer are bidirectional, or push-pull. This allows full use of the transformer core magnetization capability. Modulating the time that each MOSFET pair is on achieves regulation. Capacitor C35 in series with the power transformer T3 primary prevents DC flux imbalance. A snubber circuit (C22 and R35) absorbs resonant harmonic energy spikes. Another snubber circuit (C32, R50 and C33, R51) reduces spikes due to reverse recovery of the output rectifier, CR8. Bidirectional transient suppressor, TS1, limits high voltage spikes by detuning the snubber circuit and protecting CR8 from reverse excess PIV transients.
The gate driver circuitry for each MOSFET, transformer-coupled through T2 and T4, provides AC line isolation. It consists of a dual MOSFET driver (U1) and various damping resistors. Resistors R16, R26, R44, and R53 minimize turn on/ off delay and damp on/off ringing. Blocking capacitors C6 and C34 prevent DC flux imbalance in T2 and T4. Resistors R15 and R52 limit the turn-on surge of the H bridge MOSFET components.
A high voltage diode, CR8, provides full wave center tap rectification for the output of the power transformer. L1, C30, and C31 filter the rectified power signal. The regulated HVDC output from this supply is the input power to the RF stage of the generator.
The SYS_ECON signal from the microcontroller controls the output voltage level. This 0 to 5 Vdc signal sets the reference for the PWM control loop. An external op-amp (U2) buffers the SYS_ECON signal and provides error amp control of the PWM switcher for stable closed loop performance. Closed loop control results from comparing the feedback voltage from the output divider (R2 and R3) to the ECON input signal.
The output of U4 is a pair of complementary signals that are pulse width modulated by comparing ECON with the internal oscillator ramp waveform. At the start of an oscillator cycle, the U4 output turns on. It turns off when the ramp voltage crosses the ECON level. The two output signals from U4 (pins 11 and 14) feed the MOSFET drivers (U1A and U1B).
R20 and C12 set the U4 oscillator frequency to approximately 82 kHz. C13 controls the pulse width duty at power on for slow start control. Transformer T1 monitors the power transformer primary current, protecting against faults in the DC/DC switcher power stage and faults in the output load circuitry. CR1, CR2, CR5, and CR6 rectify the output of T1; R24 and C21 filter it. This filtered signal goes to the current limit pin (pin 9 of U4). During an overcurrent condition the U4 current limit function resets the HVDC output to a low voltage level (around 10Vdc) until the current falls. Pin 9 of U4 also allows remote shut down of the DC/DC switcher through Q1 and CR4. The shut down signal, labeled HV_ENABLE, comes from the main microcontroller on the control board.
The resistor divider on the high voltage DC output formed by R5 and R37 provides dosage error sensing, identified as HV_SEN, to the control board.
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Low Voltage Power Supply
Thermal Sensing (High Temperature Limit)
A reference voltage determined by R9 and R11 goes to the non-inverting input of comparator U3B. High temperature limit control occurs when the temperature of the NTC thermistor R22 reaches approximately 65° C, which causes the inverting input of comparator U3B to drop below the reference voltage and trip the TEMP_HI signal. Resistor R10 provides positive feedback causing approximately 10° C of hysteresis between heating and cooling thermal sense activation.
When the main microcontroller reads the TEMP_HI signal, it flashes number 451 alternately with the power settings. This disables the generator and prohibits any RF output from occurring. When the temperature drops to approximately 55° C, the circuit reverts to its low temperature state, and normal operation resumes.
Low Voltage Power Supply
The low voltage power supply is a medical grade triple output supply rated for 40 watts. It delivers a regulated +5 Vdc and ±12 Vdc output with current limit and overvoltage protection. This power supply incorporates universal mains switching which automatically adjusts for both 120 Vac and 240 Vac input voltage ranges. The low voltage power supply provides low voltage power to the RF board at connector J7. The following table shows the J7 connector pinouts:
PIN Voltage Test Point
1+5 VdcTP4
2–12 VdcTP3
3+12 VdcTP2
4 GROUND TP1
The low voltage power supply specifications are as follows:
Output Voltage Output Current Output Power*
+5 Vdc 4000 mA 20.0 W
Principles of Operation
–12 Vdc 400 mA 4.8 W
+12 Vdc 2000 mA 24.0 W
* Total output power cannot exceed 40 W.
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RF Board
RF Board
Warning
High frequency, high voltage signals that can cause severe burns are present in the RF output of the LigaSure generator. Take appropriate precautions when testing and troubleshooting the output circuitry of the generator.
The RF board incorporates a variety of processing circuits for the LigaSure generator, providing the key function of generating the output RF energy for all operative modes. It also provides the main integration function for all sub­assemblies interfaced within the LigaSure generator.
The following list identifies all the operative modes, process circuits, and integration functions provided by the RF board assembly:
Operative modes
seal
macrobipolar
bipolar
RF driver circuit
RF output circuit
RF output relays
EKG output relay
Primary sense circuits
Redundant sense circuits
Single fault protection circuit
Heat sink
Isobloc circuit
Integration functions
low voltage power supply interface
controller Interface
high voltage power supply interface
footswitch interface
handswitch interface
expansion port
RS 232 interface
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RF Board
Operative Modes
The LigaSure generator provides three modes of operation, each of which delivers bipolar RF energy through two front panel output receptacles. The seal, macrobipolar, and bipolar modes develop RF energy derived from a common RF source, located on the RF board. All modes provide output at a fixed frequency of
472.8 khz, providing an RF signal with either a continuous or pulsed mode
sinusoid waveshape.
In the seal mode, the developed RF energy originates at capacitor C59. Multiplexed by relays 1b and 6b, the RF signal developed across capacitor C59 goes to RF board output connector J10. From connector J10, a cable carries the RF energy to the front panel output receptacle, identified by the LigaSure logo, on the left side of the generator. The seal mode output RF signal exhibits a pulsed mode sinusoid waveshape. Closed loop software control initiated by the embedded microcontroller board determines pulsed mode operation.
In the macrobipolar mode, the developed RF energy originates from the cumulative output of a capacitor ladder network. Capacitors C58, C62, C59, C65, and C66 form this ladder network to generate the macrobipolar output, multiplexed through relays 2b and 3b, to RF output connector J11. From connector J11, a cable carries the RF energy to the front panel bipolar output receptacle, located on the right side of the generator below the macrobipolar and bipolar power display. The macrobipolar mode RF output signal exhibits a continuous sinusoid waveshape. The developed RF output voltage is greater than the seal or bipolar mode outputs and has a unique power curve profile to cut tissue. The microcontroller monitors the macrobipolar output and provides closed loop control by sensing the tissue impedance and automatically adjusting the output to achieve the desired clinical effect.
Principles of Operation
The bipolar mode RF operates from the same point of origin as the macrobipolar mode. Its output, multiplexed through two pairs of relays, goes to both the seal and bipolar front panel output receptacles. Relays 2b and 3b route the bipolar RF to connector J11 for output energy distribution through the bipolar output connector, while relays 4b and 5b route the bipolar RF to connector J10 for energy distribution through the seal output connector. The microcontroller determines the correct distribution of the bipolar energy based on footswitch and handswitch activation requests. The bipolar mode RF output signal also exhibits a continuous sinusoid waveshape with a unique power curve profile to coagulate tissue. The microcontroller monitors the bipolar output and provides closed loop control by sensing the tissue impedance and automatically adjusting the output to achieve the desired clinical effect.
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RF Board
RF Driver
The RF driver circuit processes a T_ON\ gating signal which enables the RF generator within the LigaSure unit. The T_ON\ signal, a TTL level pulse train signal, originates in the microcontroller. T_ON\ has a 60% duty cycle active high pulse waveshape. When activated, T_ON\ starts RF energy development with either handswitch or footswitch requests.
On the RF board, integrated circuit chips U2 and U11 process the T_ON\ signal. U2 is a quad NAND gate chip configured as a tri-state buffer that allows one of two actions:
Process the T_ON\ signal to start an RF output.
Inhibit the T_ON\ signal to disable the RF output if the system detects a single
fault failure in the RF output.
U11 is a power MOSFET driver chip that processes T_ON\ by converting the TTL level signal to a 12 V pp signal. This 12 volt signal drives Q5, the power MOSFET RF generating component. TP12 provides a test point inverted T_ON\ signal at the gate of Q5 with a 40% duty activation. U11 receives power from U10, which has an output permanently set high for all RF activation modes.
RF Output
The RF output circuit develops the energy for all operative modes of the LigaSure generator. The circuit consists of a resonant tank network: T7, L1, L2, C57, C63, C58, C62, C59, C65, C66, C60, and power MOSFET Q5. RF energy results when the T_ON\ signal, with a high voltage DC (HVDC) source present at test point TP13, switches device Q5 on and off. HVDC, originated by the high voltage power supply, provides source power for the RF output stage. When switched on/ off to develop RF, Q5 creates a signal that exhibits a half-sine waveshape of approximately 350 volts peak amplitude. This signal represents the result of resonant action that occurs between the inductive and capacitive components in the RF output circuit. The half-sine period timing is typically 800 ns for unloaded generator output. Under load, when the generator applies RF energy to tissue, the half-sine period timing increases to a maximum of 1.25 µs. The half-sine waveshape is periodic, repeating every 2.115 µs with the on/off switching of Q5.
The half-sine signal appears at test point TP11. Resonant action between inductive and capacitive components converts the half-sine signal to a continuous sinusoid RF output.
Components TS1, TS2, and TS3 provide hardware overvoltage limiting to the RF output. These components turn on and off automatically as the output peak voltage exceeds the maximum output operating voltage of 203 Vrms. TS1, TS2, and TS3 are bidirectional transient suppressor devices that limit overvoltage to approximately 245 Vrms. To arrive at the 245 Vrms limit, the system sums TS1, TS2, and TS3.
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RF Board
RF Output Relays
Based on footswitch or handswitch requests, relays RL1 through RL6 multiplex the developed RF energy for distribution to the seal and bipolar output receptacles.
Command signals originating in the microcontroller route to the RF board to relay driver chip U12. Upon receiving a positive logic +5 V signal request to the input of U12, the relay driver output goes low to energize the respective relays and close the relay switch contacts. Relay switch closure, which provides bipolar RF energy to the output, is equivalent to a double pole single throw switch. This avoids a potential patient hazard by eliminating RF energy on any output receptacle pins when footswitch and handswitch requests are not active.
The method of output relay switching is cold switching the relay contacts. Cold switched relay contacts make and break contact connections when no RF voltage or current is present. This promotes an increased life cycle and an increased mean time between failure (MTBF) for the relay by avoiding the excess contact burn and premature contact failure experienced with hot switched relay activations.
The following table identifies the output relays activated by the microcontroller command signals. It also identifies the RF output energy delivered to the respective output receptacles.
Principles of Operation
Output Command Signal Inputs to U12
Pin Signal
1 VSRF/
Vout_RLY
2 BPRF/
Vout_RLY
3 BPRF/
Bout_RLY
4 RFACT_RLY K1B None None
Output Relays Switched
RL1A, RL6A Seal LigaSure
RL4A, RL5A Bipolar LigaSure
RL2A, RL3A Bipolar Bipolar
RF Energy Delivered
Receptacle
RF Activation
EKG Output Relay
The previous table also lists a relay that does not actively switch RF energy. A positive +5 V signal, represented by the RFACT_RLY command input from the microcontroller to U12, energizes relay K1B. Relay contact K1B provides isolated SPST switch contact closure when the system generates and delivers any RF energy in any operative seal or bipolar mode. The K1B switch contact closure communicates to peripheral equipment in the operating room that RF energy is present.
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RF Board
Primary Sense Circuits
The primary sense circuits provide generator output voltage and current monitoring to the feedback microcontroller for all operative seal and bipolar modes.
Precision absolute value processing circuits, which provide non-contact magnetic coupling to the RF output, implement RF output sensing. Two factors maintain high accuracy and precision:
Op-amp compensation for non-linear diode elements
Identical voltage and current sense topology.
The primary sense circuits contain the following components:
Unit Description/Function
T1 Current transformer - provides non-contact RF tank
current monitoring to establish a weighted measure of the RF output voltage
T2 Current transformer - provides non-contact RF output
current monitoring
U5 Op-amp - provides absolute value circuit processing of the
signal recovered from R44, originating from T1
U6 Op-amp - provides absolute value circuit processing of the
signal recovered from R45, originating from T2
The circuits of U5 and U6 provide absolute value processing with a transfer gain of one. This offers maximum stability and precision, and places the correlation of developed RF output voltage and current on resistors R44 and R45.
V_SEN and I_SEN signals then go to the microcontroller to provide closed loop feedback that the actual power delivered matches the requested power as displayed on the front panel.
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RF Board
Redundant Sense Circuits
Redundant voltage and current sense circuits provide dosage error monitoring of the delivered RF energy output.
The redundant sense circuits contain the following components:
Unit Description/Function
T5 Current transformer - provides non-contact RF tank
current monitoring to establish a weighted redundant measure of the RF output voltage
T3 Current transformer - provides non-contact redundant RF
output current monitoring
CR22, CR23, CR25, CR26
R51 Resistor - provides a proportional measure of the rectified
CR12, CR13, CR15, CR16
R46 Resistor - provides a proportional measure of the recitifed
Diodes - provide full wave bridge rectification of the signal recovered from T5
signal of T5. R52 and C48 then low pass filter the R51 signal to develop the VR_SEN redundant voltage monitor.
Diodes - provide full wave bridge rectification of the signal recovered from T3
signal of T3. R47 and C46 then low pass filter the R46 signal to develop the IR_SEN redundant current monitor.
Principles of Operation
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RF Board
Single Fault Protection Circuit
This circuit provides protective mitigation to shut down the RF output if a fault condition occurs in which both the primary V_Sen and the redundant VR_Sen signals go to zero. This avoids a dosage error condition by not allowing the delivery of RF energy without the primary, redundant, or both sense signals providing monitoring control through the microcontroller.
Single fault control shuts down the RF output by deactivating both the RF generator and the high voltage power supply simultaneously.
It deactivates RF output by inhibiting the T_ON\ signal from pulsing the RF generator power FET Q5. The inhibit action occurs in the logic gating provided by chip U2, configured as a tri-state buffer with inhibit control.
It shuts down the high voltage power supply using a crowbar action on the SYS_ECON signal, which generates the high voltage DC power sourced to the RF generator. The crowbar action occurs when the Q1 FET turns on. IC chips U4A and U4B monitor the primary V_Sen and redundant VR_Sen levels, comparing these signals against a fixed reference bias voltage to determine a simultaneous mutual fault or zero volt condition. The outputs of U4A, U4B, and the Q3 drain connect together such that the corresponding inputs simulate a wired NOR logic. This implementation is necessary because a zero volt sense signal level, without RF activation, does not constitute a fault.
The single fault protection circuit, therefore, actively evaluates a single fault condition only when the RF generator produces RF energy. Two other conditions disable the single fault protection circuit:
RF startup with footswitch or handswitch requests
Pulse operation in which seal algorithm control shuts off RF energy
The RF_ACT\ command drives Q3 with active low logic switching, a function of the RF activation requests from either footswitch or handswitch. The circuit components U1, CR1 through CR3, and Q2 provide the necessary signal interface processing of the footswitch and handswitch commands to generate RF_ACT\. In addition to supporting the NOR function logic with U4, the RF_ACT\ command also starts the startup single fault disable by providing an input trigger to the monostable one shot device, U3. With each activation request, U3 actively disables single fault sensing for approximately 360 ms to allow sufficient time for the system to develop RF energy and for the primary and redundant voltage sense circuits to sense the developed energy. During seal mode operation, the control signal VSEN_MON_RE_TRIG, supplied by the microcontroller, also triggers U3.
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RF Board
Heat Sink
The heat sink dissipates heat generated by the T_ON\ switching of power FET Q5. In the normal mounting configuration, the heat sink connects electrically and mechanically to the secondary circuit protective earth-chassis ground.
Caution
The heat sink normally exists at ground potential, posing no safety hazard during RF generator activation; however, take appropriate precautions when testing and troubleshooting this area of the generator.
IsoBloc Circuit
The IsoBloc circuit provides a means of detecting a switch closure in an output accessory while maintaining electrical isolation between the generator output and ground referenced circuitry. This circuit consists of the following components:
An isolated DC power supply
A comparator to detect switch closure
An optoisolator link from the output connected circuitry to the ground referenced low voltage circuitry.
Principles of Operation
Each handswitching output of the generator is associated with its own IsoBloc power source and isolated signal paths.
Isolated Power Supply
The isolated power supply uses a quasi-resonant flyback mode converter to generate the voltages for operating the IsoBloc circuit. The power supply consists of an oscillator, a resonant flyback transformer stage, and secondary half-wave rectifiers.
The IC chip, U13, configuration is as an astable oscillator, ground referenced with an operating frequency determined by R63, R81, and C91. The U13 output drives the resonant flyback transformer stage through the ON/OFF switching of FET Q6. In the flyback operating mode, resonance occurs because of the tuning created by T8, T9, and C69. A result of the resonance, a half-sine flyback signal, exists on the drain of Q6. T8 and T9 also transformer couple the half-sine flyback signal to the RF generator, patient connective floating RF output. Components CR33, CR36, C94, and C106 then provide the half-sine rectification and filtering to generate the IsoBloc power supply voltages.
The system includes two isolated power supply voltage sources: +V_ISO_1 and +V_ISO_2. These DC voltage sources route their supplies individually to each of the seal and bipolar mode floating handswitch circuits.
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RF Board
Optoisolators
The isolated power supply voltages produced by the IsoBloc circuit connect to the active output terminals of the generator. Handswitch activation results from sensing macrobipolar or bipolar switch closure in a handheld accessory. Comparators U14 and U15 turn on a function of accessory switch closure determined by the operating bipolar mode:
U14 seal mode
U15 bipolar mode.
A switch closure provides a reverse polarity voltage to the comparator inputs. This action drives the comparator outputs low, which turns on one of the corresponding optoisolators, OPT 1 through OPT4. The optoisolator connects to an input on the 82C55 expansion port in the main microcontroller circuit, pulling the associated input low. The software interprets this action as an RF activation request, and allows RF energy to be delivered.
Integration Functions
The RF board provides the key integration function for all assembly interconnects internal to the LigaSure generator system. It also provides an output interface to peripheral devices that either monitor RF activation or provide an external means of calibrating the generator through a communication port.
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RF Board
The following table identifies the RF board functional interfaces and connective jacks:
Pins in
Interface Location
Connector Description
Low Voltage Power Supply
Controller J8 96 Connects the control board,
High Voltage Power Supply
Footswitch J4 20 Provides a signal interface to the
Handswitch (RF output receptacles)
J7 4 Connects the LVPS power input
to the RF board for distribution to all other interconnecting assemblies that require +5 V, ± 12 V DC power
providing all communication necessary to develop and control the LigaSure generator RF energy output
J6 10 Connects all necessary control
signals originating from the microcontroller to generate HVDC source power for the RF generator
footswitch audio board, routing footswitch RF request and audio tone control signals between the footswitch and control boards
J10, J11 5 Couples all handswitching
requests to generate macrobipolar and bipolar RF. The optoisolator handswitching signals interface directly with the J8 microcontroller connector.
Principles of Operation
Expansion Port J3 15 (DSUB) Interfaces low voltage power and
control signal information to operate an externally connected bipolar monitor device. The control signals interface directly between the microcontroller and the bipolar monitor.
RS-232 J1 9 (DSUB) Provides external RS-232
communication link between a personal computer and the control board to allow calibrating the LigaSure generator and to provide statistical information about its operating parameters.
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Smart Connector Boards
Smart Connector Boards
The smart connector boards provide the necessary processing electronics to determine that the correct instruments are attached to the respective LigaSure vessel sealing and bipolar output receptacles. Each output receptacle uses a smart connector board. The board optically reads the attached instrument and generates a 6-bit address code read by the microcontroller to establish a GO_NOGO, green and red smart lamp illumination. A bicolor LED, OPT7, provides the smart indicator status:
Green lamp indicator accepts the mated instrument. The microcontroller
allows RF energy delivery with a footswitch or handswitch request.
Red lamp indicator shows that the mated instrument is invalid or improperly
seated. The microcontroller disables the RF output, prohibiting RF energy delivery with a footswitch or handswitch request.
The smart read process involves optical coupling to the mated instrument plug. Six optical sensors, OPT1 through OPT6, generate the 6-bit smart address code. Each optical sensor incorporates an infrared (IR) emitter and receptor device. The IR devices read the mated plug surface for code identification:
If the emitter sends an infrared beam to a black area on the plug, the surface
reflects minimum light to the receptor. In response, the smart board bit address output sends a high output (+5 V) signal to the microcontroller.
If the emitter sends an infrared beam to a blue area on the plug, the surface
reflects maximum light to the receptor. In this case, the bit address output sends a low, zero volt, level logic signal to the microcontroller.
Comparator devices U2, U5, and U6 provide high discrimination read accuracy of the sensor signals. Signal FET Q1 turns on all six optical devices simultaneously when the microcontroller sends a +5 V signal to the Q1 gate with the BANK 1 command.
All communication to the smart board passes through connector J19. This connector interfaces with the display board, which passes smart connector signals through without processing. Display connector J1 exports the smart connector signal to connector J1 on the microcontroller, which processes the signal for a smart read.
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6Setup, Tests, and Adjustments
After unpacking or after servicing the LigaSure generator, set it up
and verify that it functions correctly.
CHAPTER
6
If the generator does not satisfactorily complete the self-test,
calibrate it to ensure its accuracy.
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Setting Up the Generator
Setting Up the Generator
Warning
Electric Shock Hazard Connect the generator power cord to a properly
grounded receptacle. Do not use power plug adapters.
Fire Hazard Do not use extension cords.
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 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.
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 outlet having the correct voltage. Otherwise product damage may result.
1. Verify the generator is off by pressing the power switch off (O).
2. Place the generator on a stable flat surface, such as a table, platform, or
Valleylab cart. Carts with conductive wheels are recommended. For details, refer to the procedures for your institution or to local codes.
Provide at least four to six inches of space from the sides and top of the generator for cooling. Normally, the top, sides, and rear panel are warm when you use the generator continuously for extended periods of time.
3. According to the procedures used by your institution, connect an equipotential
grounding cable to the grounding lug on the rear panel of the generator. Then connect the cable to earth ground.
4. Plug the generator power cord into the rear panel receptacle.
5. Plug the generator power cord into a grounded receptacle.
6. Turn on the generator by pressing the power switch on (|). Verify the
following:
All visual indicators and displays on the front panel illuminate.
Activation tones sound to verify that the speaker is working properly.
7. If the self-test is successful, a tone sounds. Verify that each display shows a
power setting of 1 watt, or a yellow bar for seal.
If the self-test is not successful, an alarm tone sounds. A number may momentarily appear in the bipolar display and, in most cases, the generator shuts down. Note the number and refer to Chapter 7, Responding to System Alarms.
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Setting Up the Generator
Connecting Bipolar or Macrobipolar Accessories
If you plan to use a footswitching bipolar instrument, you must connect a bipolar footswitch. You may also use a footswitch to activate a handswitching instrument.
Warning
Electric Shock Hazard
Do not connect wet accessories to the generator.
Ensure that all accessories and adapters are correctly connected and that no
metal is exposed.
Caution
Connect accessories to the proper receptacle type.
Connecting the Footswitch
Connect the appropriate footswitch to the corresponding receptacle on the rear panel.
Setup, Tests, and Adjustments
Figure 6-1.
Vessel sealing footswitch receptacle on the rear panel (purple band)
Figur e 6 -2.
Bipolar/macrobipolar footswitch receptacle on the rear panel (blue band)
Connecting the Handset
Connect the handset to the proper receptacle on the front panel, using a smart connector adapter as necessary. Verify that the receptacle indicator illuminates green to confirm a proper connection.
Figure 6-3.
Vessel sealing handset receptacle (purple)
Figure 6-4.
Bipolar handset receptacle (blue)
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Setting Up the Generator
Setting the Output for the Selected Mode
Caution
Set power levels to the lowest setting before testing an accessory.
1. (Optional) To display the previous settings, press the memory button.
2. To set the bipolar mode, connect the handset to the proper receptacle on the
front panel, using a smart connector adapter as necessary.
Verify that the receptacle indicator illuminates green to confirm a proper connection.
3. Set the bipolar or macrobipolar output power or the vessel sealing intensity:
To increase the power or intensity, press the Up (Δ) button.
To decrease the power or intensity, press the Down () button.
In the bipolar or macrobipolar modes, the power level changes numerically, in one watt increments from 1 to 40, and in five watt increments from 40 to 95.
In the vessel sealing mode, the sealing intensity level changes in one light bar increments, with a range of one to five bars. Increasing the intensity increases the total energy delivered to the tissue for the duration of the seal cycle.
Activating the Surgical Instrument
Notice
Do not activate the generator until the forceps have made contact with the patient. Product damage may occur.
To activate a handswitching instrument, use the controls on the instrument or on the appropriate footswitch. To activate a footswitching instrument, you must use a footswitch.
To reduce the possibility of alternate site burns that may be caused by RF leakage currents, avoid unnecessary and prolonged activation of the generator.
Handswitching Footswitching Activation Indicator
Seal N/A Press pedal Activation tone
sounds, Seal indicator illuminates
Bipolar Close forceps
tines firmly
Press pedal Activation tone
sounds, Bipolar indicator illuminates
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Periodic Safety Check
Periodic Safety Check
Perform the following safety checks every six months to verify that the generator is functioning properly. Record the test results for reference in future tests. If the generator fails to meet any of the checks, refer to Chapter 7, Troubleshooting.
Warning
Electric Shock Hazard When taking measurements or troubleshooting the
generator, take appropriate precautions, such as using isolated tools and equipment, using the “one hand rule,” etc.
Electric Shock Hazard 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.
Setup, Tests, and Adjustments
Caution
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 nonconducting edges. Use an antistatic container for transport of electrostatic-sensitive components and circuit boards.
Here is a summary of safety checks:
Inspect the generator and accessories
Inspect the internal components
Test the generator
Confirm outputs
Check leakage current and ground resistance
Recommended Test Equipment
Digital voltmeter—Fluke 77 or 87, or equivalent
True RMS voltmeter—Fluke 8920, or equivalent
Oscilloscope—Tektronix 2445, or equivalent
Leakage current tester—Use UL load device or commercially available leakage tester
Leakage table—per IEC 60601-2-2, Figure 104
5, 10, 100, 200, 400, and 1K ohm, all 250 watt, 1% tolerance, noninductive power resistors (Dale NH-250 or equivalent)
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Inspecting the Generator and Accessories
Inspecting the Generator and Accessories
Important
When testing RF equipment, follow these test procedures to duplicate manufacturer test data. Lead inductance and stray capacitance can adversely affect readings. Carefully select suitable ground points to avoid ground loop error in measurements.
The accuracy of most RF instruments is approximately 1-5% of full scale. Using uncompensated scope probes causes large errors when measuring high voltage RF waveforms.
Equipment
Bipolar footswitch and vessel sealing footswitch
Bipolar adapter
Bipolar instrument cords
Vessel sealing instrument cords
Procedure
1. Turn off the generator, and disconnect the power cord from the wall
receptacle.
Rear Panel
2. Check the rear panel footswitch receptacles for obstructions or damage.
Check for a secure fit by inserting the bipolar footswitch or vessel sealing footswitch connector into the appropriate receptacle.
3. Remove the fuse and verify correct voltage and current rating. Refer to
Chapter 4, Performance Characteristics.
If either connection is loose, re-apply the plug to secure the plug/ receptacle mating. If the connection is still loose, try another footswitch for the receptacle. If the connection is still loose, replace the footswitch board assembly. Refer to Chapter 8, Footswitch Board for further instructions.
Front Panel
4. Check the bipolar handset receptacle on the front panel for obstructions or
damage. You can connect either a footswitching or handswitching bipolar/ macrobipolar instrument to this receptacle. Insert the handset into this receptacle to verify a secure fit.
If the connection is loose, re-apply the handset to secure the handset/ receptacle mating. If the connection is still loose, try another handset. If the connection is still loose, replace the front panel. Refer to Chapter 8, Front Panel and Display Board for further instructions.
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Inspecting the Generator and Accessories
5. Check the vessel sealing handset receptacle on the front panel for obstructions
or damage. Connect a footswitching vessel sealing instrument to this receptacle, inserting the handset plug firmly into the receptacle to verify a secure fit.
If the connection is loose, re-apply the handset to secure the handset/ receptacle mating. If the connection is loose, try another handset. If the connection is still loose, replace the front panel. Refer to Chapter 8, Front Panel and Display Board for further instructions.
6. With the bipolar and vessel sealing handsets properly mated, check that the
smart indicator lamp illuminates green. If the smart indicator lamp illuminates red, use the following procedure:
a. Verify that you have connected the correct LigaSure handset to the seal
receptacle.
b. Verify that the LigaSure handset fits securely in the seal receptacle.
c. Verify that you have connected a smart bipolar adapter to the bipolar
receptacle.
Power Cord
Setup, Tests, and Adjustments
7. Unplug the power cord from the wall receptacle, then remove the cord from
the unit.
8. Inspect the power cord for damage.
9. Reconnect the power cord to the generator and wall receptacle.
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Inspecting Internal Components
Inspecting Internal Components
Equipment
Phillips screwdriver
Caution
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.
Procedure
To perform the inspection, follow this procedure:
1. Remove the three screws that secure the cover to the chassis. Lift the cover off
the chassis. Save the cover and screws for reinstallation.
2. Verify that all connectors are firmly seated.
3. Inspect each board for damaged components, loose or damaged wires, cracks,
or corrosion.
If you find evidence of damage on the control board, display board, high voltage power supply board, smart board, low voltage power supply, or footswitch board, replace the board. Refer to Chapter 8, Replacement Procedures for the corresponding replacement instructions.
If you find evidence of damage on the RF board, replace the board only if the damage is severe. Refer to Chapter 8, RF Board and Heat Sink for further instructions.
4. To reinstall the cover, slide the cover onto the chassis from the rear of the unit.
Re-install the three screws that secure the cover to the chassis. Refer to Chapter 8, Cover for further instructions.
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Using the RS-232 Serial Port
The RS-232 serial port allows communication between an attached computer or terminal and the main microcontroller of the generator. This communication link lets you obtain information regarding calibration values, power and mode settings, and the alarm number history of the generator. You can also use the link when testing or calibrating the generator.
Equipment
Phillips screwdriver
Step 1 – Establish the Communications Link
A. Turn off the generator.
B. On the rear panel of the generator, remove the screws that secure the metal
plate that covers the serial port. Set the screws and plate aside for re­installation.
C. Connect a standard DB 9 serial cable to your computer and to the generator
serial port.
Using the RS-232 Serial Port
Setup, Tests, and Adjustments
Pin 2 is the serial output data line
Pin 3 is the serial data input line
Pin 5 is the reference line
D. On your computer, enter your communication program. Configure your
computer for 9600 baud, 8 data bits, 1 stop bit, and no parity.
E. Turn on the generator. Your computer displays the following information:
LigaSure Generator
Copyright Valleylab 1998
Master
Master Software Revision: #.##
Feedback Software Revision: #.##
Serial Number: SSSSSSS
Startup Date/Time: MM/DD/YY HR:MN:SC
NOTE: # represents the software version number for the listed microcontrollers. S represents the serial number.
VS_SC = XX
BP_SC = XX
“XX” represents smart connector codes.
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Using the RS-232 Serial Port
Step 2 – Enter Commands
You can enter commands to display data about the generator. Begin each command with a colon (:) and end with a hard return. The # symbol represents a numeric value that you enter with specific commands as noted.
The following table lists the commands you can use:
Command Action
:PT Prints Real Time Clock date and time as MM/DD/YY
HH:MM
:PSA Prints the total generator activation time in each mode
(Seal, Macrobipolar, and Bipolar) in hours, minutes, and seconds
:PSB Prints the total number of generator activations in each
mode (Seal, Macrobipolar, and Bipolar)
:PSC Prints the date and time of the latest calibration
:PSE# Prints the number of times the system has recorded a
specific error code # in non-volatile memory
:PSF Prints the 10 most recent system errors recorded in
non-volatile memory
Format: Error # MM/DD/YY HH:MM
:PSL Prints the 10 next most recent system errors (11-20)
recorded in non-volatile memory
Format: Error # MM/DD/YY HH:MM
:PSK Prints the total number of generator activations in any
mode
:PSO Prints the total time the generator power has been on,
in hours and minutes
:PSP Prints the average power setting for each mode: Seal,
Macrobipolar, and Bipolar
:PSS Prints the number of activations per side (Seal,
Bipolar), by mode, and total
:PSR Prints the number of regrasps detected
:PM Prints the generator model name, Master and
Feedback software version numbers, and the device serial number
#CAL Causes the generator to enter the calibration mode
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Testing the Generator
Testing the Generator
Disconnect the Computer from the Generator
A. Turn off the generator.
B. Disconnect the DB 9 cable from the generator.
C. Position the panel over the serial port and install the screws that secure it to
the rear panel of the generator.
Turning on the generator initiates an internal self-test to verify the calibration and the operation of the speaker, all indicators, the displays, and some internal components.
Warning
Use the generator only if the self-test has been completed as described. Otherwise, inaccurate power outputs may result.
To test the generator, follow this procedure:
Setup, Tests, and Adjustments
1. Turn on the generator by pressing the front panel On (|) switch. Verify the
following:
All visual indicators and displays on the front panel illuminate.
Activation tones sound to verify that the speaker is working properly.
2. If the self-test is successful, a tone sounds. Verify the following:
The macrobipolar and bipolar displays each show a power setting of one
watt.
The seal display shows one amber bar illuminated.
If the self-test is not successful, an alarm tone sounds. A number may momentarily appear in the bipolar display and, in most cases, the generator shuts down. Note the number and refer to Chapter 7, Responding to System Alarms.
If you removed and/or replaced the battery, alarm number 105 may appear in the bipolar display when you turn on the generator. If this happens, calibrate the generator.
Confirming Outputs
Use this procedure to ensure the accuracy of the generator. Always confirm the output
After calibrating the generator
or
Every six months
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Testing the Generator
Equipment
Valleylab smart connector adapter (P/N LS 0500) required to confirm RF
output
Valleylab bipolar forceps cord (E0509)
Current transformer, Pearson 411
True RMS voltmeter (such as the Fluke 8920 or equivalent)
10, 100, 200, 500, and 1000 ohm 1% noninductive power resistors
Bipolar footswitch
Checking the Vessel Sealing Output
The LigaSure vessel sealing mode uses a proprietary algorithm that varies the output based on the progress of the sealing action. This algorithm makes a conventional measurement of the output impossible. The seal mode uses the same output circuit and sense circuits as the bipolar mode; therefore, a positive check on the bipolar output also confirms the seal output.
Checking the Bipolar Output
1. Verify that the generator successfully completes the self-test as described in
Testing the Generator.
2. Establish the communications link as described in Using the RS-232 Serial
Port in this chapter.
3. Connect the test equipment for bipolar output.
a. Connect the smart connector adapter to the bipolar instrument receptacle.
With the adapter connected, the RS-232 port reads an E4 code.
b. Connect the bipolar forceps cord to the adapter.
c. Pass one lead of the cord through the current transformer and connect the
current transformer to the voltmeter.
d. Connect the 100 ohm power resistor across the end of the cord.
e. Connect the bipolar footswitch to the bipolar footswitch receptacle on the
rear panel.
4. Press the bipolar up button (Δ) and set the power to 50 watts.
5. Test the output current for the selected bipolar mode.
a. Press the footswitch pedal and, while activating the generator, note the
output on the voltmeter.
b. Release the footswitch pedal.
c. Based on the voltmeter setting and the current transformer you are using,
calculate and record the output current.
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Testing the Generator
6. Verify that the generator output is 705 ± 53 mA rms (50 W ± 7.5 W).
If the output is outside the specified range, calibrate the generator as described in calibration steps 4, 5, 6, and 7. Then repeat this procedure. If the output remains outside the specified range, call the Valleylab Service Center.
Checking Low Frequency Leakage Current and Ground Resistance
Check the low frequency leakage current and ground resistance before returning the LigaSure generator to clinical use.
F ig u re 6 -1 .
The leakage current test circuit per IEC 60601-1
Equipment
DVM
Leakage current test circuit
Output Receptacles Source Current
1. Set the DVM to AC volts (200 millivolts [mV]) and connect the leakage
current test circuit.
2. Turn on (|) the generator.
3. Measure between all the output receptacles and earth ground. Record the
largest reading.
Setup, Tests, and Adjustments
4. Determine the leakage current using the conventional one microamp per one
mV.
5. Verify under normal conditions (ground closed, normal polarity) the leakage
current is less than 10 microamps (µA). If the leakage current is greater than 10 µA, call the Valleylab Service Center.
6. Verify single fault conditions (ground open) the leakage current is less than or
equal to 50 µA. If the leakage current is greater than 50 µA, call the Valleylab Service Center.
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Testing the Generator
Chassis or Earth Leakage
1. Set the DVM to AC volts (200 mV) and connect the leakage current test
circuit.
2. Turn on the generator.
3. Measure between the chassis and earth ground.
4. Determine the leakage current using the conventional one microamp (µA) per
one mV.
5. Verify under normal conditions (ground closed, normal polarity) the leakage
current is less than 100 µA. If the leakage current is greater than 100 µA, call the Valleylab Service Center.
6. Verify single fault conditions (ground open) the leakage current is less than or
equal to 500 µA. If the leakage current is greater than 500 µA, call the Valleylab Service Center.
Output Receptacles Sink Current
1. Set the DVM to AC volts (200 millivolts [mV]) and connect the leakage
current test circuit.
2. Turn on the generator (110 or 220 Vac) and connect the end of the leakage
current test circuit to mains voltage through a 120 kΩ resistor.
3. Connect the other side of the IEC leakage load to all output receptacles.
4. Determine the leakage current using the conventional 1 microamp (µA) per
1mV.
5. Verify the leakage current is less than or equal to 50 µA. If the leakage current
is greater than 50 µA, call the Valleylab Service Center.
Checking High Frequency Leakage Current and Ground Resistance
Check the high frequency leakage current and ground resistance before returning the LigaSure generator to clinical use. Check the leakage current
After calibrating the generator
Every six months
Equipment
200 ohm, 250 watt, noninductive resistor
Current transformer
True RMS voltmeter (Fluke 8920 or equivalent)
Vessel sealing and bipolar footswitches and bipolar handswitching accessories
Leakage setup per IEC 60601-2-2, clause 19.101 or 19.102
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Testing the Generator
Checking Seal High Frequency Leakage Current
The LigaSure vessel sealing mode uses a proprietary algorithm that varies the output based on the progress of the sealing action. This algorithm makes a conventional measurement of the RF leakage impossible. The vessel sealing mode uses the same output circuit and sense circuits as the bipolar mode; therefore, a positive check on the bipolar RF leakage also confirms the vessel sealing RF leakage.
Checking Macrobipolar and Bipolar High Frequency Leakage Current
1. Remove the vessel sealing accessories.
2. Connect the 200 ohm load from one side of the bipolar output through the
current transformer to the equipotential ground lug on the rear of the generator.
3. Connect the current transformer to the true RMS voltmeter.
4. Connect a bipolar footswitch to the bipolar footswitch receptacle on the rear
panel.
5. Activate the footswitch in each mode (macrobipolar and bipolar) at the
maximum control setting. Record the leakage current. It should not exceed 69 mA for any mode.
Setup, Tests, and Adjustments
6. If the high frequency leakage exceeds 69 mA, call the Valleylab Service
Center for further instructions.
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Calibrating the LigaSure Generator
Calibrating the LigaSure Generator
Calibration comprises seven steps. During calibration you verify information specific to the LigaSure generator, adjust the date, and adjust the clock. You also adjust several values, or factors, that ensure the proper operation of the generator.
The following table summarizes the calibration steps and the values you can adjust. Certain values you cannot adjust, but you must verify them.
Notice
After completing any calibration step, follow the instructions displayed on the terminal.
Step Description Adjustable?
1 LigaSure Generator Data
Generator Model Number Master microcontroller software version Feedback microcontroller software version
2 Calendar
Month Day of the month Ye ar
3 Clock
Hour Minute
4 Current sense gain factor Yes
5 Voltage sense gain factor Ye s
6 ECON factor Yes
7 Save calibration values Yes
No (verify value) No (verify value) No (verify value)
Yes Yes Yes
Yes Yes
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Calibrating the LigaSure Generator
Preparing for Calibration
Equipment
Bipolar footswitch
Bipolar adapter and bipolar cable (E0509)
True RMS voltmeter (Fluke 8920A or equivalent)
Current transformer (Pearson 411 or equivalent)
Noninductive power resistors (such as Dale NH-250 with these values: 10, 500, and 1000 ohms)
Personal computer (PC) with RS-232 cable or terminal capable of RS-232 communication at 9600 baud, 8 data bits, 1 stop bit, and no parity
Before Calibration
1. Before turning on the power, check the CPU battery voltage from TPI
(ground) to the body of the battery, and record it.
2. Attach the computer to the generator: Connect a standard DB 9 serial cable to
your computer and to the generator serial port.
Setup, Tests, and Adjustments
3. On your computer, enter your communication program. Configure your
computer for 9600 baud, 8 data bits, 1 stop bit, and no parity – with no handset connected.
4. Turn the LigaSure generator power on and confirm that a proper serial
interface exists by checking the response message from the LigaSure generator.
5. If the battery has been replaced, expect to see error code 105.
6. Keep the serial cable on throughout calibration.
NOTE: If the unit falls out of specification or exhibits alarms during power output tests, complete the calibration procedure.
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Calibrating the LigaSure Generator
Step 1 – Verify LigaSure Generator Data
A. From the serial port on the LigaSure generator, establish RS-232
communications as described on page 6-9, then verify LigaSure generator data.
B. Plug a footswitch into the bipolar footswitch connector on the rear panel.
C. Enter the command #cal. This should start calibration mode.
D. Press Enter on the terminal to increment the calibration steps. You can pass
over any step, but you must perform steps 4 (Isns), 5 (Vsns), and 6 (ECON) in order.
E. Whenever a calibration step calls for keying the generator, press the
MACROBIPOLAR (left) pedal on the footswitch.
F. Follow the step instructions shown on the computer monitor.
G. To exit calibration mode, turn off generator power, then turn it back on.
Step 2 – Adjust the Calendar
A. Refer to the following table for the commands to adjust the date.
Month Day Year
y: month + 1 u: day + 1 i: year + 1
Y: month + 10 U: day + 10 I: year + 10
b: month - 1 n: day –1 m: year - 1
B: month – 10 N: day - 10 M year - 10
B. When the current date is correct, press Enter to proceed to the next step.
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Calibrating the LigaSure Generator
Step 3 – Adjust the Clock
A. Refer to the following table for the commands to adjust the time.
Hour Minute Second
y: Hour + 1 u: Minute + 1 i: Second + 1
Y: Hour + 10 U: Minute + 10 I: Second + 10
b: Hour - 1 n: Minute –1 m: Second - 1
B: Hour - 10 N: Minute – 10 M Second - 10
B. When the current time is correct, press Enter to proceed to the next step.
Step 4 – Check and Adjust the Current Sense Gain
A. Follow the instructions on the terminal.
B. Connect a 10 ohm load to the bipolar output jacks, with one side passing
through a Pearson 411 current transformer connected to a Fluke 8920A RMS voltmeter.
Setup, Tests, and Adjustments
C. Activate the generator in macrobipolar mode using the rear footswitch
receptacle.
D. Referring to the following table for the correct commands, adjust the gain
until the meter reads 2.08 A.
I gain
i: gain + 1
I: gain + 10
m: gain - 1
M: gain - 10
LigaSure Vessel Sealing Generator Service Manual 6-19
Page 96
Calibrating the LigaSure Generator
Step 5 – Check and Adjust the Voltage Sense Gain
A. Follow the instructions on the terminal.
B. Replace the 10 ohm resistor with a 1000 ohm resistor.
C. Activate the generator in macrobipolar mode using the rear footswitch
receptacle.
D. Referring to the following table for the correct commands, adjust the gain
until the meter reads 250 mA.
V gain
i: gain + 1
I: gain + 10
m: gain - 1
M: gain - 10
Step 6 – Check and Adjust the ECON Factor
A. Econ Cal Lo, Calibrates High Voltage Control (Lo):
Activate macrobipolar into a 500 ohm load until value displayed on terminal screen stabilizes within one count.
This step requires no gain adjustment.
B. Econ Cal Hi, Calibrates High Voltage Control (HI):
Activate macrobipolar into a 500 ohm load until value displayed on terminal screen stabilizes within one count.
This step requires no gain adjustment.
Step 7 – Save Calibration Values
A. Enter S to save the calibration gain values to non-volatile RAM.
B. This step does not affect the date and time. The system saves these values as
soon as you complete the steps in which you adjust them.
6-20 LigaSure Vessel Sealing Generator Service Manual
Page 97
1Troubleshooting
If the generator is not functioning properly, use the information in
this chapter to troubleshoot the system:
CHAPTER
7
• Inspect the generator, connectors and cords, and internal components.
• Identify and correct a malfunction.
• If the system displays an alarm number, take the appropriate action to correct the alarm condition.
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Inspecting the Generator
Inspecting the Generator
If the generator malfunctions, perform a visual inspection, checking for obvious conditions that may have caused the problem:
Check the generator for visible signs of physical damage.
Verify that all accessory cords connect properly.
Check the power cord. If you find exposed wires, cracks, frayed insulation, or a damaged connector, replace the cord.
Open the fuse drawer and inspect the fuse housing and fuses for damage and corrosion. Verify that the fuses are firmly seated.
An internal component malfunction in the generator can damage the fuses. You may need to replace the fuses if the generator fails the self-test or stops functioning. Refer to Chapter 8, Fuses for further instructions.
Inspecting Receptacles
Equipment
Bipolar footswitch
Vessel sealing footswitch
Bipolar instrument cords (handswitching and footswitching)
Vessel sealing instrument cords (footswitching)
Procedure
To perform the inspection, follow this procedure:
1. Turn off the generator by pressing the power switch on the front panel to the
off position (O).
2. Disconnect the power cord from the wall receptacle.
3. Check the two footswitch receptacles on the rear panel for obstructions or
damage. Check for a secure fit by inserting each footswitch connector into the appropriate receptacle.
If any connection is loose, try another footswitch for the receptacle. If the connection is still loose, replace the footswitch board assembly. Refer to Chapter 8, Footswitch Board for further instructions.
7-2 LigaSure Vessel Sealing Generator Service Manual
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Inspecting the Generator
4. Check the bipolar handset receptacle on the front panel for obstructions or
damage. You can connect either a footswitching or handswitching bipolar/ macrobipolar handset to this receptacle. Insert the handset plug firmly into this receptacle to verify a secure fit.
If the connection is loose, try another handset. If the connection is still loose, replace the front panel. Refer to Chapter 8, Front Panel and Display Board for further instructions.
5. Check the vessel sealing handset receptacle on the front panel for obstructions
or damage. Connect a footswitching vessel sealing handset to this receptacle, inserting the plug firmly into the receptacle to verify a secure fit.
If the connection is loose, try another handset. If the connection is still loose, replace the front panel. Refer to Chapter 8, Front Panel and Display Board for further instructions.
6. With the bipolar and vessel sealing handsets properly mated, check that the
smart indicator lamp illuminates green. If the smart indicator lamp illuminates red, use the following procedure:
a. Verify that you have connected the correct LigaSure handset to the seal
receptacle.
b. Verify that the LigaSure handset fits securely in the seal receptacle.
c. Verify that you have connected a smart bipolar adapter to the bipolar
receptacle.
d. Verify that the smart bipolar adapter fits securely in the bipolar receptacle.
7. If the smart indicator lamp remains red, replace the front panel. Refer to
Chapter 8, Front Panel and Display Board for further instructions.
Troubleshooting
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Inspecting the Generator
Inspecting Internal Components
Equipment
Phillips screwdriver
Caution
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.
Procedure
To perform the inspection, follow this procedure:
1. Remove the three screws that secure the cover to the chassis. Lift the cover off
the chassis. Save the cover and screws for reinstallation.
2. Verify that all connectors are firmly seated.
3. Inspect each board for damaged components, loose or damaged wires, cracks,
or corrosion.
If you find evidence of damage on the control board, display board, high voltage power supply board, smart board, low voltage power supply, or footswitch board, replace the board. Refer to Chapter 8, Replacement Procedures for the corresponding replacement instructions.
If you find evidence of damage on the RF board, replace the board only if the damage is severe. Refer to Chapter 8, RF Board and Heat Sink for further instructions.
4. To reinstall the cover, slide the cover onto the chassis from the rear of the unit.
Reinstall the three screws that secure the cover to the chassis. Refer to Chapter 8, Cover for further instructions.
7-4 LigaSure Vessel Sealing Generator Service Manual
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