Force FX Generator C User Guide Feb 2011

User’s Guide

Force FX

TM

Electrosurgical Generator C

1012638

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. TM It is intended as a guide for servicing the Force FX Electrosurgical Generator C only. Additional information is available in the Force FX Electrosurgical Generator C Service Manual. Equipment covered in this manual: Force FX Electrosurgical Generator C 110 V ~ Nominal/230 V ~ Nominal (auto select)

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 C User’s Guide

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 FX Electrosurgical Generator C User’s Guide

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

Chapter 1. Introduction Overview... 1-2 Instant Response Technology... 1-2 Bipolar Modes... 1-2 Monopolar Cut and Coag Modes... 1-3 Simultaneous Coag... 1-4 REM Contact Quality Monitoring System... 1-4 How the REM System Works... 1-4 Electrodes Without the REM Safety Feature... 1-5 Ultrasonic Electrosurgery... 1-5

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... 2-9 Footswitch Receptacles... 2-10 Monopolar Footswitch Receptacles... 2-10 Bipolar Footswitch Receptacle... 2-10 Power Entry Module... 2-11 Activation Tone Volume Control... 2-11 Option Panel... 2-12

Chapter 3. Patient and Operating Room Safety General... 3-2 Fire/Explosion... 3-3 Fire Hazard with Oxygen Circuit Connections... 3-3 Electrosurgical Smoke... 3-3 Inadvertent Radio Frequency Burns... 3-4 Ensure Proper Connections... 3-4 Accessories... 3-4 Servicing... 3-5

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Before Surgery... 3-5 Active Accessories... 3-5 Patient Return Electrodes... 3-6 Shunt Cords... 3-6 Generator... 3-6 During Surgery... 3-7 Generator Power Settings... 3-7 Forceps... 3-8 Suction Coagulators... 3-8 Contact with Metal Objects... 3-8 Active Accessories... 3-9 Patient Return Electrodes... 3-9 Laparoscopic Procedures... 3-10 After Surgery... 3-11

Chapter 4. Before Surgery Quick Setup Instructions... 4-2 Setting Up the Generator... 4-3 Preparing for Bipolar or Macrobipolar Surgery... 4-5 Connections for Bipolar or Macrobipolar Surgery... 4-5 Setting the Bipolar Output... 4-6 Preparing for Monopolar Surgery... 4-7 Connections for Monopolar Surgery... 4-7 Applying a Patient Return Electrode to the Patient... 4-9 Using Two Generators Simultaneously... 4-10 Pacemakers... 4-10 Selecting Cut and Coag Modes... 4-11 Simultaneous Coag... 4-11 Preparing for Ultrasonic Electrosurgery... 4-13 Connecting the Patient Return Electrode... 4-13 Connecting the CUSA Handpiece with CEM Nosecone . . 4-13 Setting the Output Power... 4-15 Simultaneous Coag... 4-15

Chapter 5. During Surgery Checking Accessory Connections... 5-2 Checking the Patient Return Electrode... 5-2 Changing the Mode... 5-2 Selecting the Power Setting... 5-3 Changing the Power Setting... 5-3 Techniques for Keeping Power Settings Low... 5-4

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Force FX Electrosurgical Generator C User’s Guide

Typical Power Settings... 5-5 Activating the Surgical Instrument... 5-6 Adjusting the Volume of Activation Tones... 5-7 Responding to Alarms... 5-7 REM Alarm... 5-7 Non-REM Patient Return Electrode Alarm... 5-8 System Alarm... 5-8

Chapter 6. After Surgery Preparing the Generator for Reuse... 6-2 Step 1 – Disconnect the Accessories... 6-2 Step 2 – Clean the Generator... 6-2 Storing the Generator... 6-2

Chapter 7. Troubleshooting General Troubleshooting Guidelines... 7-2 Correcting a REM Alarm Condition... 7-2 Applying Additional Patient Return Electrodes... 7-3 Correcting Malfunctions... 7-5 Responding to System Alarms... 7-10

Chapter 8. Maintenance and Repair Responsibility of the Manufacturer... 8-2 Routine Maintenance... 8-2 Returning the Generator for Service... 8-3 Step 1 – Obtain a Return Authorization Number... 8-3 Step 2 – Clean the Generator... 8-3 Step 3 – Ship the Generator... 8-4 Covidien Service Centers... 8-4

Chapter 9. Technical Specifications Performance Characteristics... 9-2 General... 9-2 Dimensions and Weight... 9-2 Operating Parameters... 9-2 Transport and Storage... 9-3 Duty Cycle... 9-3 Internal Memory... 9-3 Audio Volume... 9-4 REM Contact Quality Monitor... 9-4 Serial Port... 9-5 RF Activation Port... 9-5

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Expansion Port... 9-6 Low Frequency (50–60 Hz) Leakage Current... 9-6 High Frequency (RF) Leakage Current... 9-6 Input Power... 9-7 Power Cord Specification... 9-8 Standards and IEC Classifications... 9-9 Class I Equipment (IEC 60601-1)... 9-9 Type CF Equipment (IEC 60601-1)/Defibrillator Proof... 9-10 Liquid Spillage (IEC 60601-2-2 Clause 44.3)... 9-10 Electromagnetic Interference... 9-10 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)... 9-10 Voltage Transients (Emergency Generator Mains Transfer)... 9-10 Output Characteristics... 9-11 Maximum Output for Bipolar and Monopolar Modes . . . 9-11 Maximum Output for Ultrasonic Electrosurgery... 9-12 Available Power Settings in Watts... 9-12 Output Waveforms... 9-15 Output Power vs. Resistance Graphs... 9-17 Bipolar Graphs... 9-17 Monopolar Cut Graphs... 9-24 Monopolar Coag Graphs... 9-31

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Force FX Electrosurgical Generator C User’s Guide

Chapter 1 Introduction This chapter includes information about: TM • Instant Response technology

• Bipolar modes • Monopolar cut and coag modes • Simultaneous coag • REM Contact Quality Monitoring System • Ultrasonic electrosurgery.

Caution Read all warnings, cautions, and instructions provided with this generator before using. Read the instructions, warnings, and cautions provided with electrosurgical accessories before using. Specific instructions are not included in this manual.

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Overview

Overview The Covidien Force FX Electrosurgical Generator C (also called the Force FX-C generator in this manual) is an isolated output electrosurgical generator that provides power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. Features include: • 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 Covidien REM Contact Quality Monitoring System • Support for ultrasonic electrosurgery using the CUSATM System 200 or CUSA EXcelTM TM and a CUSA handpiece with CUSA electrosurgical module (CEM ) 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 • Force GSUTM system and Force Argon system compatibility. Covidien electrosurgical generators, patient return electrodes, and active accessories are designed to work as a system. Covidien offers a selection of patient return electrodes and electrosurgical instruments that are fully compatible with this generator. When considering other manufacturer’s patient return electrodes and/or active accessories, customers should seek detailed user instructions and warning information from the manufacturer.

Instant Response Technology The Force FX-C generator automatically senses resistance and adjusts the output voltage to maintain a consistent effect across different tissue density. This adjustment is based on the selected mode (bipolar or cut modes only), the power setting, and the level of tissue resistance. The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking.

Bipolar Modes Delicate tissue requires less heat to desiccate quickly. The Force FX-C generator provides low voltage, continuous current for faster desiccation without sparking. 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.

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Force FX Electrosurgical Generator C User’s Guide

Monopolar Cut and Coag Modes

• Precise (low) may be used when a high degree of precision and fine control over the amount of desiccation are essential. Voltage is kept low to prevent sparking. The power remains constant over a specific range of tissue resistance, allowing a consistent tissue effect.

Introduction

Three bipolar modes are available: precise, standard, and macrobipolar.

• Standard (medium) may be used for most bipolar applications. Voltage is kept low to prevent sparking. The power remains constant over a specific range of tissue resistance, allowing a consistent tissue effect. • Macro (macrobipolar) may be used for bipolar cutting or rapid coagulation. Voltage is higher and there is more power than with the other two bipolar modes. For details about the output characteristics, refer to Output Characteristics on page 9-11.

Monopolar Cut and Coag Modes Three cut modes-low, pure, and blend-allow a wide range of power settings necessary to perform diverse surgical procedures. • Low may be used for a cut with little or no sparking; useful for delicate tissue or laparoscopic surgery. • Pure may be used when you desire a clean, precise cut in any tissue with little or no hemostasis. • Blend may be used where slower cutting and additional hemostasis is desired. The three coagulation modes-desiccate, fulgurate, and spray-help control the size of the area and the depth of penetration during tissue coagulation. • 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. • Fulgurate coagulates tissue by sparking from the active electrode, through air, to the patient tissue. Since sparks may spray unpredictably from the electrode during fulguration, using fulguration for delicate tissue or in confined areas can complicate surgery. Accidental sparking to adjacent areas can occur as tissue at the surgical site dries and becomes more resistant to current flow. • Spray affords optimum fulguration; penetration is less deep and the tissue area is larger than with the fulgurate mode. For details about the output characteristics, refer to Output Characteristics on page 9-11.

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REM Contact Quality Monitoring System

Simultaneous Coag When you simultaneously activate two monopolar instruments for coag output, each receives a percentage of the power setting set for the selected mode. The amount of power each instrument receives depends on the tissue resistance sensed by the generator at each surgical site. Generally, the site with lower resistance receives proportionately more power. The combined total output power does not exceed the coag power setting. You can also use a CUSA handpiece with a CEM nosecone for simultaneous coag when you connect a monopolar instrument to the Monopolar 2 Instrument receptacle. Only Desiccate coag is available; the maximum power is 70 watts.

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 FX-C generator uses the REM Contact Quality Monitoring System to monitor the quality of electrical contact between the patient return electrode and the patient. The TM REM system is designed to minimize the risk of burns at the return electrode site due to a reduction in patient contact area during monopolar electrosurgery. Use of any return electrode other than a REM PolyhesiveTM 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. 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.

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Force FX Electrosurgical Generator C User’s Guide

Ultrasonic Electrosurgery

Warning Using a conventional patient return electrode without the REM safety feature will not activate the REM Contact Quality Monitoring System.

Introduction

Electrodes Without the REM Safety Feature

When you use a patient return electrode that does not have the REM safety feature, the REM system cannot monitor the patient contact area as previously described. The REM system can monitor only the pin-to-pin resistance at the connector and can detect broken wires or connectors in the return electrode cord.

Ultrasonic Electrosurgery The Force FX-C generator works in conjunction with the CUSA System 200 and CUSA EXcel for procedures where combined ultrasonic dissection and electrosurgical cutting and coagulation is desired, either simultaneously or independently. In addition to convenience, the combination of ultrasonic vibration plus simultaneous electrosurgical current prevents charring of the tip and decreases sticking and disruption of coagulum, leading to more effective hemostasis. When you connect a CUSA handpiece with a CEM nosecone to the generator for ultrasonic electrosurgery, it limits the monopolar output power automatically. • The maximum power you can set for monopolar cut is 100 watts. • The maximum power you can set for monopolar coag is 70 watts. When you activate the handpiece for cut or coag output, the Low cut mode or the Desiccate coag mode is in effect automatically. The remaining cut modes and coag modes are not available.

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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

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

REM alarm indicator CEM indicator

Bipolar controls

Cut controls

Bipolar Instrument receptacle

Coag controls

Monopolar 2 Instrument receptacle

Monopolar 1/CEM Instrument receptacle Power Switch This switch supplies power to the generator. Press ( | ) to turn on the generator. Press (O) to turn off the generator.

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

Force FX Electrosurgical Generator C User’s Guide

Bipolar Controls

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.

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

Precise mode button Select for fine bipolar tissue desiccation.

Controls, Indicators and Receptacles

Power buttons Press Δ to increase the power. Press ∇ to decrease the power.

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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Bipolar Instrument Receptacle

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

You can connect either a footswitching or handswitching bipolar instrument to the Bipolar receptacle. Connect a footswitching instrument with a two-pin connector.

or Connect a handswitching instrument with a three-pin connector.

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Force FX Electrosurgical Generator C User’s Guide

Bipolar Instrument Receptacle

Monopolar Cut Controls Cut indicator When you activate cut, this indicator illuminates yellow and an activation tone sounds.

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

Power buttons Press Δ to increase the power. Press ∇ to decrease the power.

Low mode button Select for a cut with little or no sparking.

Controls, Indicators and Receptacles

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

Blend mode button Select for slower cutting and additional hemostasis.

Pure mode button Select for an even cut with little or no hemostasis. This is the default monopolar cut mode.

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Monopolar Coag Controls

Monopolar Coag Controls Coag display Shows the power setting, in watts, for the selected mode.

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

Desiccate mode button Select to desiccate the area of tissue that is in direct contact with the active electrode.

Coag indicator When you activate coag, this indicator illuminates blue and an activation tone sounds.

Power buttons Press Δ to increase the power. Press ∇ to decrease the power.

Spray mode button Select to evenly coagulate a wide area of tissue with a spray of sparks; penetration is less deep and tissue area is larger than in fulgurate mode.

Fulgurate mode button Select to fulgurate an area of tissue with a spray of sparks. This unit is equipped with an additional fulgurate mode which incorporates a lower crest factor (LCF) than the factory default fulgurate mode. Details about this additional fulgurate mode, LCF fulgurate, are provided in Chapter 4, Before Surgery. This is the default monopolar coag mode. However, the default coag mode can be changed to either Desiccate or Spray through the serial port on the rear panel; contact your institution’s Biomedical Engineering Department.

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Force FX Electrosurgical Generator C User’s Guide