Force FX Generator 8CS Service Manual Feb 2011

Service Manual

Force FX

TM

Electrosurgical Generator 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 FX Electrosurgical Generator 8CS only. Additional users information is available in the Force FX Electrosurgical Generator 8CS User’s Guide. Equipment covered in this manual: Covidien Force FX Electrosurgical Generator 8CS 110 V ~ Nominal / 230 V ~ Nominal (auto selected) The Force FX Electrosurgical Generator 8CS Service Manual consists of two parts: the text (part 1 of 2) and a Schematics Supplement (part 2 of 2) which contains the schematics. 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 FX Electrosurgical Generator 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

EvidentTM MWA 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

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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. 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 OBLICATION 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 FX Electrosurgical Generator 8CS Service Manual

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

Chapter 1. Introduction General Description... 1-2 List of Components... 1-2 Service Personnel Safety... 1-3 General... 1-3 Active Accessories... 1-3 Patient Return Electrodes... 1-4 Fire/Explosion Hazards... 1-4 Electric Shock Hazards... 1-4 Servicing... 1-5 Calibration... 1-5 Cleaning... 1-6

Chapter 2. Controls, Indicators, and Receptacles Front Panel... 2-2 Bipolar Controls... 2-3 Bipolar Instrument Receptacle... 2-4 Monopolar Cut Controls... 2-5 Monopolar Coag Controls... 2-6 Monopolar Instrument Receptacles... 2-7 REM Alarm Indicator... 2-8 Rear Panel... 2-8 Footswitch Receptacles... 2-9 Monopolar Footswitch Receptacles... 2-9 Bipolar Footswitch Receptacle... 2-9 Power Entry Module... 2-10 Activation Tone Volume Control... 2-10 Option Panel... 2-11

Chapter 3. Technical Specifications Performance Characteristics... 3-2 General... 3-2 Dimensions and Weight... 3-2 Operating Parameters... 3-2 Transport and Storage... 3-3 Duty Cycle... 3-3

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Internal Memory... 3-3 Audio Volume... 3-4 REM Contact Quality Monitor... 3-4 Serial Port... 3-5 RF Activation Port... 3-5 Expansion Port... 3-6 Low Frequency (50–60 Hz) Leakage Current... 3-6 High Frequency (RF) Leakage Current... 3-6 Input Power... 3-7 Power Cord Specification... 3-7 Standards and IEC Classifications... 3-8 Class I Equipment (IEC 60601-1)... 3-9 Type CF Equipment (IEC 60601-1)/Defibrillator Proof... 3-9 Liquid Spillage (IEC 60601-2-2 Clause 44.3)... 3-9 Electromagnetic Interference... 3-9 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)... 3-9 Voltage Transients (Emergency Generator Mains Transfer)... 3-10 Output Characteristics... 3-16 Maximum Output for Bipolar and Monopolar Modes . . . 3-16 Maximum Output for Ultrasonic Electrosurgery... 3-17 Available Power Settings in Watts... 3-17 Output Waveforms... 3-19 Output Power vs. Resistance Graphs... 3-20 Bipolar Graphs... 3-20 Monopolar Cut Graphs... 3-27 Monopolar Coag Graphs... 3-35

Chapter 4. Principles of Operation Block Diagram... 4-2 Functional Overview... 4-3 Instant Response Technology... 4-3 Ultrasonic Electrosurgery... 4-3 Simultaneous Coag... 4-3 REM Contact Quality Monitoring System... 4-4 Control Board... 4-6 Microcontrollers... 4-6 Main Microcontroller... 4-6 Feedback Microcontroller... 4-7

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Force FX Electrosurgical Generator 8CS Service Manual

Shared RAM... 4-8 I/0 Expansion... 4-8 Keyboard Interface and Activation Inputs... 4-8 Power Supply Supervisor Circuit... 4-9 A/D and D/A Conversion... 4-9 Waveform Generation (T_ON ASIC)... 4-9 T_ON Average Check... 4-10 Audio Alarm... 4-10 Serial Interface... 4-10 Dosage Error Algorithm... 4-11 Instant Response Algorithm... 4-12 Front Panel... 4-13 Membrane Keyboard... 4-13 Power Switch... 4-13 REM Connector/Switch... 4-13 CEM Mechanism Switch... 4-13 Display Board... 4-14 RF Indicator Lamps... 4-14 REM Indicators... 4-14 LED and Seven-Segment Display Drivers... 4-14 CEM Switch Circuit... 4-15 Mode Selection and Power Control Switches... 4-15 Footswitch Board... 4-17 Footswitch Decode Circuit... 4-17 Audio Circuit... 4-18 Power Supply/RF Board... 4-20 Power Supply/RF Board Interfaces... 4-20 High Voltage Power Supply... 4-21 Low Voltage Power Supply... 4-23 RF Output Stage... 4-24 Spark Control Circuit... 4-27 RF Leakage Reduction Circuit... 4-27 REM Circuit... 4-28 IsoBloc Circuit... 4-28 Temperature Sense Circuits... 4-29

Chapter 5. Setup, Tests, and Adjustment Setting Up the Generator... 5-2 Connections for Bipolar or Macrobipolar Surgery... 5-4 Setting the Bipolar Output... 5-5

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Connections for Monopolar Surgery... 5-6 Selecting Cut and Coag Modes... 5-8 Simultaneous Coag... 5-8 Using Two Generators Simultaneously... 5-10 Connecting the CUSA Handpiece with CEM Nosecone . . . 5-11 Setting the Output Power... 5-12 Simultaneous Coag with a CUSA System... 5-12 Changing the Mode... 5-12 Changing the Power Setting... 5-13 Activating the Surgical Instrument... 5-13 Periodic Safety Check... 5-14 Recommended Test Equipment... 5-15 Inspecting the Generator and Accessories... 5-16 Inspecting the Internal Components... 5-17 Testing the Generator... 5-18 Verifying REM Function... 5-19 Confirming Outputs... 5-20 Checking the Bipolar Output... 5-20 Checking Output for the Monopolar Cut Modes... 5-21 Checking Output for the Monopolar Coag Modes... 5-22 Checking Low Frequency Leakage Current and Ground Resistance... 5-23 Checking High Frequency Leakage Current... 5-24 Calibrating the Generator... 5-26 Preparing for Calibration... 5-27 Entering Calibration Mode... 5-27 Exiting Calibration Mode... 5-28 Verifying the Generator Data... 5-28 Adjusting the Calendar... 5-29 Adjusting the Clock... 5-30 Checking and Adjusting the REM Oscillator Frequency and Impedance... 5-30 Checking and Adjusting the Current Sense Gain... 5-31 Checking and Adjusting the Voltage Sense Gain... 5-33 Checking and Adjusting the Reactance Gain... 5-36 Checking and Adjusting the ECON Factor... 5-38 Using the RS-232 Serial Port... 5-42 Establish the Communications Link... 5-42 Enter the Commands... 5-43

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Force FX Electrosurgical Generator 8CS Service Manual

Disconnect the Computer from the Generator... 5-46

Chapter 6. Troubleshooting Inspecting the Generator... 6-2 Inspecting the Receptacles... 6-2 Inspecting the Internal Components... 6-3 Correcting Malfunctions... 6-4 Responding to System Alarms... 6-11 Correcting T_ON ASIC Malfunctions... 6-22 Correcting Battery-Backed RAM Malfunctions... 6-24

Chapter 7. Replacement Procedures Interconnect Diagram... 7-2 Battery Replacement... 7-3 Control Board Replacement... 7-4 Display Board Replacement... 7-5 Remove the Display Board... 7-5 Install the Display Board... 7-6 Display Board Seven-Segment LED Replacement... 7-7 Fan Replacement... 7-7 Footswitch Board Replacement... 7-8 Front Panel Replacement... 7-9 Remove the Front Panel Assembly... 7-9 Remove and Reinstall the Front Panel Components... 7-9 Install the Front Panel Assembly... 7-10 Front Panel REM Module Replacement... 7-11 Front Panel Power Switch Replacement... 7-12 Fuse Replacement... 7-13 Replacing Fuses in the Fuse Drawer... 7-13 Replacing the Fuse on the Power Supply/RF Board... 7-14 Left Front Heat Sink and Component Replacement... 7-15 Remove the Left Front Heat Sink... 7-15 Replace Left Front Heat Sink Components... 7-16 Install the Left Front Heat Sink... 7-16 Left Rear Heat Sink and Component Replacement... 7-17 Remove the Left Rear Heat Sink... 7-17 Replace Left Rear Heat Sink Components... 7-18 Install the Left Rear Heat Sink... 7-18 Right Heat Sink and Component Replacement... 7-19 Remove the Right Heat Sink... 7-19 Replace Right Heat Sink Components... 7-20

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Install the Right Heat Sink... 7-21 Low Voltage Power Supply Replacement... 7-22 Remove the Low Voltage Power Supply... 7-22 Install the Low Voltage Power Supply... 7-22 Power Entry Module Replacement... 7-25 Remove the Power Entry Module... 7-25 Install the Power Entry Module... 7-25 Power Supply/RF Board Replacement... 7-27 Remove the Power Supply/RF Board Assembly... 7-27 Remove Components from the Old Board... 7-28 Install Components on the New Board... 7-29 Install the Power Supply/RF Board Assembly... 7-30

Chapter 8. Repair Policy and Procedures Responsibility of the Manufacturer... 8-2 Returning the Generator for Service... 8-2 Obtain a Return Authorization Number... 8-2 Clean the Generator... 8-3 Ship the Generator... 8-3 Returning Circuit Boards... 8-3 Service Centers... 8-3

Chapter 9. Service Parts Ordering Replacement Parts... 9-2 Generator Assembly... 9-3 Parts List... 9-5 Front Panel Assembly... 9-7 Parts List... 9-9 Control Board Components... 9-10 Display Board Components... 9-10 Footswitch Board Components... 9-12 Power Supply/RF Board Assembly... 9-15 Parts List... 9-17 Power Supply/RF Board Components... 9-19

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Force FX Electrosurgical Generator 8CS Service Manual

Chapter 1 Introduction This manual provides instructions for servicing the Covidien Force FX Electrosurgical Generator 8CS with Instant ResponseTM technology. This chapter introduces the features and components of the generator and reviews the precautions associated with generator repair.

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General Description

General Description The Covidien Force FX Electrosurgical Generator 8CS is an isolated output electrosurgical generator that provides the appropriate power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. It includes the following features: • Instant Response technology • Three bipolar modes: precise (low), standard (medium), and macro (macrobipolar) • Three monopolar cut modes: low, pure, and blend • Three monopolar coag modes: desiccate (low), fulgurate (medium), and spray (high) • Support for simultaneous coagulation • The REMTM Contact Quality Monitoring System • Support for ultrasonic electrosurgery using the CUSA EXcelTM system and a CUSATM handpiece with a CUSA electrosurgical module (CEMTM) nosecone • Handswitch or footswitch activation • Recall of most recently used mode and power settings • Adjustable activation tone volume • An RF activation port, RS-232 serial port, and expansion port • ValleylabTM Argon Gas Delivery Unit II system compatibility

List of Components The Force FX Electrosurgical Generator 8CS is a self-contained unit, consisting of a main enclosure (cover and base) and power cord. The main components of the generator are the following: • Front panel components-power switch; controls for setting the modes and output power; a button for recalling the power settings and modes that were used last; receptacles for connecting electrosurgical accessories; and indicators that alert you to the current settings and patient return electrode status. • Rear panel components-volume control; three footswitch receptacles; power entry module; equipotential grounding lug; and three ports (serial port, RF activation port, and expansion port). • Internal components-Control (microcontroller) board; Display board; Footswitch board; Power Supply/RF board; low voltage power supply; fan; 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 4, Principles of Operation.

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Force FX Electrosurgical Generator 8CS Service Manual

Service Personnel Safety

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.

Introduction

Service Personnel Safety

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 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 a Valleylab Argon Gas Delivery Unit II or a CUSA EXcel unit). 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.

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.

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Service Personnel Safety

Caution Accessories must be connected to the proper receptacle type. In particular, bipolar accessories must be connected to the Bipolar Instrument receptacle only. Improper connection may result in inadvertent generator activation or a REM contact quality monitor alarm. Set power levels to the lowest setting before testing an accessory. Notice During bipolar electrosurgery, do not activate the generator until the forceps have made contact with the patient. Product damage may occur.

Patient Return Electrodes Warning Using a patient return electrode without the REM 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 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. To allow stored energy to dissipate after power is disconnected, wait at least five minutes before replacing parts.

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Force FX Electrosurgical Generator 8CS Service Manual

Service Personnel Safety

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.

Introduction

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 (10 Ω) while calibrating the current sense gain. Otherwise, product damage will result.

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Service Personnel Safety

Notice Do not activate the generator with any load resistor lower than 1000 Ω while calibrating the voltage sense gain for bipolar output. Otherwise, product damage will result. Do not activate the generator with any load resistor lower than 3000 Ω while calibrating the voltage sense gain for the Low and Pure cut modes. Do not activate the generator with any load resistor lower than 2000 Ω while calibrating the voltage sense gain for the Blend mode. Otherwise, product damage will result. Do not adjust the current sense gain (I factor), the voltage sense gain (V factor), or the reactance gain (Z factor) while the generator is activated. 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. Otherwise, the default calibration values are used. 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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Force FX Electrosurgical Generator 8CS Service Manual

Chapter 2 Controls, Indicators, and Receptacles This chapter describes the front and rear panels, including all controls, indicators, receptacles, the fuse drawer, and ports.

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Front Panel Layout of controls and indicators on the front panel

Recall button Pressing this button sets the generator to the most recently used mode and power settings.

Bipolar controls

Bipolar instrument receptacle

CEM indicator Cut controls

Monopolar 1/CEM instrument receptacle

Power switch This switch supplies power to the generator. To turn on the generator, press (|). To turn off the generator, press (O).

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REM alarm indicator

Coag controls

Monopolar 2 instrument receptacle

Patient return electrode receptacle For monopolar electrosurgery, connect a patient return electrode to this receptacle.

Force FX Electrosurgical Generator 8CS Service Manual

Bipolar Controls Buttons and indicators for bipolar controls Bipolar indicator When you activate bipolar, this indicator illuminates blue and an activation tone sounds.

Bipolar display Shows the power setting, in watts, for the selected mode.

Power buttons Press Δ to increase the power.

Press ∇ to decrease the power.

Precise mode button Select for fine bipolar tissue desiccation.

Controls, Indicators, and Receptacles

Mode indicators Illuminate green when you press the corresponding mode button.

Macro mode button Select for macrobipolar output.

Standard mode button Select for standard bipolar tissue desiccation. This is the default bipolar mode.

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