Force EZ Generator CS/8CS Service Manual Feb 2011

Service Manual TM

Force EZ

Electrosurgical Generator CS/8CS

Preface 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 Force EZ electrosurgical generators CS and 8CS only. Additional users information is available in the Force EZ Electrosurgical Generator CS User’s Guide and Force EZ Electrosurgical Generator 8CS User’s Guide. TM

Equipment covered in this manual: Force EZ electrosurgical generators CS and 8CS Device is compliant with the European Communities Council Directive 93/42/EEC, Medical Device Directive.

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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Force EZ Electrosurgical Generator CS/8CS Service Manual

Limited Warranty Covidien warrants each covered product listed below to be free from defects in material and workmanship for normal use and service for the period(s) set forth below. Covidien’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it (or its authorized distributor) within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Covidien’s satisfaction, that the product is defective. This limited warranty does not apply to any product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident. The warranty periods for Covidien products are as follows:

ForceTriadTM Energy Platform

One year from date of shipment

Electrosurgical Generators

One year from date of shipment

Cool-tipTM RFA Generator

One year from date of shipment

RFG-3CTM Plus Lesion Generator

One year from date of shipment

LigaSureTM Vessel Sealing System

One year from date of shipment

LigaSureTM Reusable Instruments

One year from date of shipment

Mounting Fixtures (all models)

One year from date of shipment

Footswitches (all models)

One year from date of shipment

ValleylabTM Argon Gas Delivery Unit II

One year from date of shipment

RapidVacTM Smoke Evacuator

One year from date of shipment

LigaSureTM Sterile Single Use Items

Sterility only as stated on packaging

Cool-tipTM Sterile Single Use Items

Sterility only as stated on packaging

Sterile Single Use Items

Sterility only as stated on packaging

Patient Return Electrodes

Shelf life only as stated on packaging

Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the products sold hereunder shall be limited to the aggregate purchase price for the products sold to the customer. This limited warranty is non-transferable and runs only to the original purchaser of the covered product(s). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of products and for any form of indirect, tort, or consequential damages.

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This limited warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes arising under or relating in any way to this limited warranty is the District Court of the County of Boulder, State of Colorado, USA. Covidien reserves the right to make changes in covered products built or sold by it at any time without incurring any obligation to make the same or similar changes to equipment previously built or sold by it. THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS EXPRESSLY PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

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Force EZ Electrosurgical Generator CS/8CS Service Manual

Table of Contents Preface... ii Conventions Used in this Guide... ii Limited Warranty... iii

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

Chapter 2. Introduction General Description... 2-2 List of Components... 2-2 Instant Response Technology... 2-3 Bipolar Modes... 2-3 Monopolar Cut and Coag Modes... 2-3 Cut Modes... 2-3 Coag Modes... 2-3 REM Contact Quality Monitoring System... 2-4 How the REM System Works... 2-4 Electrodes Without the REM Safety Feature... 2-5 Special Features... 2-5 Low (Desiccate) Coag Settings... 2-5 High (Fulgurate) Coag Settings... 2-5 Recall of Most Recently Used Modes and Power Settings... 2-5 Default Coag Mode... 2-6 Original Default Settings... 2-6

Chapter 3. Controls, Indicators, and Receptacles Front Panel... 3-2 Rear Panel... 3-6 Option Panel... 3-8

Chapter 4. Technical Specifications Performance Characteristics... 4-2 General... 4-2

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Dimensions and Weight... 4-2 Operating Parameters... 4-2 Transport and Storage... 4-3 Duty Cycle... 4-3 Internal Memory... 4-4 Audio Volume... 4-4 REM Contact Quality Monitor... 4-5 Serial Port... 4-6 RF Activation Port... 4-6 Input Power... 4-7 Power Cord Specification... 4-8 Low Frequency (50-60 Hz) Leakage Current... 4-8 High Frequency (RF) Leakage Current... 4-8 Standards and IEC Classifications... 4-9 Class I Equipment (IEC 60601-1)... 4-9 Type CF Equipment (IEC 60601-1)/Defibrillator Proof... 4-9 Liquid Spillage (IEC 60601-2-2 Clause 44.3)... 4-10 Electromagnetic Interference... 4-10 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)... 4-10 Voltage Transients (Emergency Generator Mains Transfer)... 4-11 Output Characteristics... 4-16 Available Power Settings in Watts... 4-16 Maximum Output for Force EZ Electrosurgical Generator C/8C Modes... 4-18 Output Waveforms... 4-18 Output Power vs. Resistance Graphs... 4-20 Bipolar Graph... 4-20 Monopolar Cut Graphs... 4-22 Monopolar Coag Graphs... 4-24 Output Power vs. Generator Settings... 4-29

Chapter 5. Principles of Operation Functional Overview... 5-3 Instant Response Technology... 5-3 REM Contact Quality Monitoring System... 5-3 Control Board... 5-5 Microcontrollers... 5-5 Shared RAM... 5-7 Real-time Clock... 5-7

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I/0 Expansion... 5-7 Keyboard Interface and Activation Inputs... 5-8 Power Supply Supervisor Circuit... 5-8 A/D and D/A Conversion... 5-8 Waveform Generation (T_ON ASIC)... 5-8 T_ON Average Check... 5-9 Audio Alarm... 5-9 Serial Interface... 5-10 Dosage Error Algorithm... 5-10 Instant Response Algorithm... 5-11 Display Board... 5-13 Bipolar, Cut, and Coag Power Setting Encoders... 5-13 RF Indicator Lamps... 5-13 LED and Seven-segment Display Drivers... 5-14 Mode Selection Switches... 5-15 REM Switch Circuit... 5-15 Front Panel Footswitch Circuit... 5-16 Footswitch Board... 5-17 Power Supply/RF Board... 5-18 Power Supply/RF Board Interfaces... 5-19 High Voltage Power Supply... 5-19 Low Voltage Power Supply... 5-22 RF Output Stage... 5-22 Spark Control Circuit... 5-26 RF Leakage Sensing and Reduction Circuit... 5-26 REM Circuit... 5-27 IsoBloc Circuit... 5-27 Audio Circuit... 5-28 Footswitch Decode Circuit... 5-30 Temperature Sense Circuit... 5-30

Chapter 6. Setup, Tests, and Adjustments Setting up the Generator... 6-2 Connections for Bipolar Surgery... 6-4 Setting the Bipolar Output... 6-6 Connections for Monopolar Surgery... 6-7 Setting the Cut and Coag Output... 6-9 Using Two Generators Simultaneously... 6-10 Setting Up the Special Features... 6-10 Changing the Mode... 6-12

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Changing the Power Setting... 6-12 Activating the Surgical Instrument... 6-13 Periodic Safety Check... 6-14 Recommended Test Equipment... 6-15 Inspecting the Generator and Accessories... 6-15 Inspecting the Internal Components... 6-16 Testing the Generator... 6-17 Verifying REM Function... 6-18 Confirming Outputs... 6-19 Checking Low Frequency Leakage Current and Ground Resistance... 6-22 Checking High Frequency Leakage Current and Ground Resistance... 6-24 Calibrating the Generator... 6-25 Preparing for Calibration... 6-25 Entering Calibration Mode... 6-26 Exiting Calibration Mode... 6-27 Calibration Step 1 – Verify the Force EZ Electrosurgical Generator C/8C Data... 6-27 Calibration Step 2 – Adjust the Calendar... 6-28 Calibration Step 3 – Adjust the Clock... 6-29 Calibration Step 4 – Check the REM Impedance... 6-29 Calibration Step 5 – Check and Adjust the Current Sense Gain... 6-30 Calibration Step 6 – Check and Adjust the Voltage Sense Gain... 6-33 Calibration Step 7 – Check and Adjust the Reactance Gain... 6-35 Calibration Step 8 – Check and Adjust the ECON Factor. . 6-37

Chapter 7. Troubleshooting Inspecting the Generator... 7-2 Correcting Malfunctions... 7-3 Responding to System Alarms... 7-13 Correcting Integrated Circuit (IC) Malfunctions... 7-30

Chapter 8. Replacement Procedures Interconnect Diagram... 8-2 Battery... 8-2 Control Board... 8-3 Display Board... 8-5 Removing the Display Board... 8-5

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Installing the Display Board... 8-6 Display Board Seven-Segment LED... 8-7 Footswitch Board Assembly... 8-8 Front Panel... 8-9 Removing the Front Panel Assembly... 8-9 Removing and Reinstalling the Front Panel Components... 8-10 Installing the Front Panel Assembly... 8-11 Front Panel Footswitch Receptacle... 8-12 Front Panel Knob... 8-13 Front Panel Power Switch... 8-14 Front Panel REM Lever... 8-15 Fuses... 8-16 Replacing Fuses in the Fuse Drawer... 8-16 Replacing the Fuse on the Low Voltage Power Supply. . . 8-16 Replacing the Fuse on the Power Supply/RF Board... 8-18 Handle... 8-19 Left Front Heat Sink Component... 8-20 Remove the Left Front Heat Sink... 8-20 Replacing the Left Front Heat Sink Components... 8-21 Installing the Left Front Heat Sink... 8-21 Left Rear Heat Sink Component... 8-22 Removing the Left Rear Heat Sink... 8-22 Replacing the Left Rear Heat Sink Components... 8-23 Installing the Left Rear Heat Sink... 8-24 Right Heat Sink Component... 8-25 Removing the Right Heat Sink... 8-25 Replacing the Right Heat Sink Components... 8-26 Installing the Right Heat Sink... 8-27 Low Voltage Power Supply... 8-28 Removing the Low Voltage Power Supply... 8-28 Installing the Low Voltage Power Supply... 8-29 Power Entry Module... 8-30 Remove the Power Entry Module... 8-30 Installing the Power Entry Module... 8-31 Power Supply/RF Board... 8-32 Removing the Power Supply/RF Board and Heat Sinks . . . 8-32 Installing the Power Supply/RF Board and Heat Sinks . . . 8-33

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Chapter 9. Repair Policy and Procedures Responsibility of the Manufacturer... 9-2 Returning the Generator for Service... 9-2 Step 1 – Obtain a Return Authorization Number... 9-2 Step 2 – Clean the Generator... 9-3 Step 3 – Ship the Generator... 9-3 Circuit Boards... 9-3 Service Centers... 9-3

Chapter 10. Service Parts Ordering Replacement Parts... 10-2 Force EZ Electrosurgical Generator C/8C Assembly... 10-3 Generator Assembly Parts List... 10-5 Control Board Components... 10-7 Footswitch Board Components... 10-8 Power Supply/RF Board Components... 10-9

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Chapter 1 Service Personnel Safety Covidien stresses safety in the use and servicing of its electrosurgical equipment. This chapter presents the following: • Safety information • Warnings, Cautions, and Notices Refer to the Preface, Conventions Used in this Guide, for further information on Warnings, Cautions, and Notice

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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 Patient Safety – Use the generator only if it has completed the self-test as described. Otherwise, inaccurate power outputs may result. The instrument receptacles on this generator are designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing so will cause simultaneous activation of the instruments.

Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment (except an Argon Gas Delivery Unit II). 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. 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. To avoid product damage, connect the power cord to a wall receptacle having the correct voltage.

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Force EZ Electrosurgical Generator CS/8CS Service Manual

Warnings, Cautions, and Notices

Caution Connect accessories to the proper receptacle type. In particular, connect bipolar accessories to the Bipolar Instrument receptacle only. Improper connection may result in inadvertent generator activation or a REM Contact Quality Monitor alarm.

Service Personnel Safety

Active Accessories

Patient Return Electrodes Warning Using a patient return electrode without the REMTM safety feature will not activate the REM Contact Quality Monitoring System.

Fire/Explosion Hazards Warning Danger: Explosion Hazard – Do not install the generator in the presence of flammable anesthetics, gases, liquids, or objects. Fire Hazard – Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories that are activated or hot from use can cause a fire. Use a holster to hold electrosurgical accessories safely away from patients, surgical team, 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. 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 and in the associated mounting and heat sink hardware 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 this 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.

Notice After installing a new low voltage power supply, verify that the voltages are correct.

Calibration Caution To avoid inadvertent coupling and/or shunting of RF currents around the resistor elements, keep the resistors at least 4" (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 completing any calibration step, proceed to the next step to save the values from the completed calibration step. Do not activate the generator with any load resistor higher than 10 ohms while calibrating the current sense gain. Otherwise, product damage will result. Do not activate the generator with any load resistor lower than 750 ohms while calibrating the voltage sense gain for bipolar output. Otherwise, product damage will result.

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Force EZ Electrosurgical Generator CS/8CS Service Manual

Warnings, Cautions, and Notices

Do not activate the generator with any load resistor lower than 3000 ohms while calibrating the voltage sense gain for the pure cut mode. Otherwise, product damage will result. Do not activate the generator with any load resistor lower than 2000 ohms while calibrating the voltage sense gain for the blend mode. Otherwise, product damage will result. After calibration, the generator will be ready to use only after you initiate the internal self-test by turning the generator off, then on.

Service Personnel Safety

Notice

Calibrate the generator after you install a new battery. All data stored in internal memory, including calibration constants, is lost when the battery is replaced. Calibrate the generator after you install a new Control board. Otherwise it uses default calibration values. Calibrate the generator after you install a new heat sink or replace components on the heat sink. Component differences may affect output waveforms. Calibrate the generator after you install a new Power Supply/RF board. Component differences may affect output waveforms.

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

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Chapter 2 Introduction This manual provides instructions for servicing the Covidien Force EZ Electrosurgical Generator CS/8CS. This chapter introduces the features and components of the generator. Additional information about using the generator is available in the Force EZ Electrosurgical Generator CS User’s Guide or Force EZ Electrosurgical Generator 8CS User’s Guide.

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General Description

General Description The Covidien Force EZ Electrosurgical Generator CS/8CS is an isolated output electrosurgical generator that provides the power for cutting, desiccating, and fulgurating tissue during electrosurgery. The generator is specifically designed for use in bipolar or monopolar electrosurgery. It includes the following features: • Instant Response Technology • Standard bipolar mode • Two monopolar cut modes: pure and blend • Two monopolar coag modes: low (desiccate) and high (fulgurate) • The Covidien REM Contact Quality Monitoring System, which protects patients against burns at the patient return electrode site • User selectable coag settings • User selectable default settings • Adjustable activation tone volume • Force GSU and Argon Gas Delivery Unit II system compatibility

List of Components The Force EZ Electrosurgical Generator CS/8CS is a self-contained unit. It consists of a main enclosure (cover and base) and power cord. It includes the following components: • Front panel – the power switch; controls for setting the modes and output power; a footswitch receptacle and button for selecting bipolar or accessory output; receptacles for connecting electrosurgical accessories, and indicators that alert you to the selected modes and the patient return electrode status. • Rear panel – the power entry module, volume control, two footswitch receptacles, equipotential grounding lug, and option panel. • Internal components – include the Control (microcontroller) board, Display board, Footswitch board, Power Supply/Radio Frequency (RF) board, low voltage power supply, and heat sinks. A handle is located on the underside of the chassis. For details about the interaction of the main components and circuit board descriptions, refer to Chapter 5, Principles of Operation.

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Instant Response Technology

Instant Response Technology The Force EZ Electrosurgical Generator CS/8CS automatically senses resistance and adjusts the current and output voltage to maintain a consistent effect across different tissue density. This adjustment is based on the selected mode, the power setting, and the level of tissue resistance. As tissue resistance increases, the generator outputs constant current followed by constant power followed by constant voltage. The system controls maximum output voltage to reduce capacitive coupling and video interference and to minimize sparking. This technology applies to the bipolar mode, the cut modes, and the low 2 and low 3 coag settings. It does not apply to the low 1, high 1, and high 2 coag settings.

The Force EZ Electrosurgical Generator CS/8CS provides a standard bipolar mode usable for most bipolar applications. Delicate tissue requires less heat to desiccate quickly. The generator provides low voltage, continuous current for faster desiccation without sparking.

Introduction

Bipolar Modes

The possibility of sparking increases as desiccated tissue dries and becomes more resistant. The generator protects against sparking by limiting the bipolar voltage at relatively high levels of tissue resistance. For details about the bipolar output characteristics, refer to Chapter 4, Technical Specifications.

Monopolar Cut and Coag Modes Cut Modes Two cut modes – pure and blend – allow a wide range of power settings to perform diverse surgical applications. • Pure provides an even cut with little or no hemostasis. It offers good cutting performance over a wide range of tissue resistance. • Blend provides cutting ability with additional hemostasis.

Coag Modes Two coagulation modes help control the size of the area and the depth of penetration during tissue coagulation. The low (desiccate) mode has three settings; the high (fulgurate) mode, two settings. You can select, as default settings, one low setting and one high setting. For a description of each setting, refer to Special Features on page 2-5. • Low (desiccate) dehydrates and destroys tissue without sparking or cutting. Because the active electrode directly touches the tissue, more current reaches the patient. Desiccation places the greatest demand on the patient return electrode.

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REM Contact Quality Monitoring System

• High (fulgurate) coagulates tissue by sparking from the active electrode, through air, to the patient tissue. In this mode, you have less control over sparking, thus it is best suited for coagulation of larger areas. Accidental sparking to adjacent areas can occur as tissue at the surgical site dries and becomes more resistant to current flow. For details about the monopolar output characteristics, refer to Chapter 4, Technical Specifications.

REM Contact Quality Monitoring System During monopolar electrosurgery, a patient return electrode is always required to safely recover the current that flows through the patient’s body and return it to the generator. A reduction in surface area contact or poor conductivity between the patient and the return electrode can cause the current to become concentrated, potentially resulting in burns at the return electrode site. The Force EZ Electrosurgical Generator CS/8CS uses the REM Contact Quality Monitoring System to monitor the quality of electrical contact between the patient return electrode and the patient. The REM system is designed to eliminate the risk of burns at the return electrode site. Use of any return electrode other than a REM patient return electrode may compromise the REM safety feature. This could result in a patient burn.

How the REM System Works The REM system continuously measures the resistance at the return electrode site and compares it to a standard range of safe resistance (between 5 and 135 ohms), thus eliminating intermittent false alarms that could result from small changes in resistance. The REM system also adapts to individual patients by measuring the initial contact resistance between the patient and the patient return electrode and lowering the baseline resistance if the contact resistance drops. A REM alarm sounds and the generator stops producing output power when either of the following occurs: • The measured resistance is below 5 ohms or above 135 ohms, the limits of the standard range of safe resistance. • An increase in contact resistance is greater than 40% from the initial measurement (baseline resistance).

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Force EZ Electrosurgical Generator CS/8CS Service Manual