User s Guide. Force FX TM. Electrosurgical Generator C

Transcription

1 User s Guide Force FX TM Electrosurgical Generator C

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3 User s Guide Force FX TM Electrosurgical Generator C

4 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 TM 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. ii Force FX Electrosurgical Generator C User s Guide

5 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: ForceTriad TM Energy Platform Electrosurgical Generators Cool-tip TM RFA Generator RFG-3C TM Plus Lesion Generator LigaSure TM Vessel Sealing System LigaSure TM Reusable Instruments Mounting Fixtures (all models) Footswitches (all models) Valleylab TM Argon Gas Delivery Unit II RapidVac TM Smoke Evacuator LigaSure TM Sterile Single Use Items Cool-tip TM Sterile Single Use Items Sterile Single Use Items Patient Return Electrodes One year from date of shipment One year from date of shipment One year from date of shipment One year from date of shipment One year from date of shipment One year from date of shipment One year from date of shipment One year from date of shipment One year from date of shipment One year from date of shipment Sterility only as stated on packaging Sterility only as stated on packaging Sterility only as stated on packaging 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. Force FX Electrosurgical Generator C User s Guide iii

6 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. iv Force FX Electrosurgical Generator C User s Guide

7 Table of Contents Preface ii Conventions Used in this Guide ii Limited Warranty iii Chapter 1. Introduction Overview Instant Response Technology Bipolar Modes Monopolar Cut and Coag Modes Simultaneous Coag REM Contact Quality Monitoring System How the REM System Works Electrodes Without the REM Safety Feature Ultrasonic Electrosurgery Chapter 2. Controls, Indicators and Receptacles Front Panel Bipolar Controls Bipolar Instrument Receptacle Monopolar Cut Controls Monopolar Coag Controls Monopolar Instrument Receptacles REM Alarm Indicator Rear Panel Footswitch Receptacles Monopolar Footswitch Receptacles Bipolar Footswitch Receptacle Power Entry Module Activation Tone Volume Control Option Panel Chapter 3. Patient and Operating Room Safety General Fire/Explosion Fire Hazard with Oxygen Circuit Connections Electrosurgical Smoke Inadvertent Radio Frequency Burns Ensure Proper Connections Accessories Servicing Force FX Electrosurgical Generator C User s Guide v

8 Before Surgery Active Accessories Patient Return Electrodes Shunt Cords Generator During Surgery Generator Power Settings Forceps Suction Coagulators Contact with Metal Objects Active Accessories Patient Return Electrodes Laparoscopic Procedures After Surgery Chapter 4. Before Surgery Quick Setup Instructions Setting Up the Generator Preparing for Bipolar or Macrobipolar Surgery Connections for Bipolar or Macrobipolar Surgery Setting the Bipolar Output Preparing for Monopolar Surgery Connections for Monopolar Surgery Applying a Patient Return Electrode to the Patient Using Two Generators Simultaneously Pacemakers Selecting Cut and Coag Modes Simultaneous Coag Preparing for Ultrasonic Electrosurgery Connecting the Patient Return Electrode Connecting the CUSA Handpiece with CEM Nosecone Setting the Output Power Simultaneous Coag Chapter 5. During Surgery Checking Accessory Connections Checking the Patient Return Electrode Changing the Mode Selecting the Power Setting Changing the Power Setting Techniques for Keeping Power Settings Low vi Force FX Electrosurgical Generator C User s Guide

9 Typical Power Settings Activating the Surgical Instrument Adjusting the Volume of Activation Tones Responding to Alarms REM Alarm Non-REM Patient Return Electrode Alarm System Alarm Chapter 6. After Surgery Preparing the Generator for Reuse Step 1 Disconnect the Accessories Step 2 Clean the Generator Storing the Generator Chapter 7. Troubleshooting General Troubleshooting Guidelines Correcting a REM Alarm Condition Applying Additional Patient Return Electrodes Correcting Malfunctions Responding to System Alarms Chapter 8. Maintenance and Repair Responsibility of the Manufacturer Routine Maintenance Returning the Generator for Service Step 1 Obtain a Return Authorization Number Step 2 Clean the Generator Step 3 Ship the Generator Covidien Service Centers Chapter 9. Technical Specifications Performance Characteristics General Dimensions and Weight Operating Parameters Transport and Storage Duty Cycle Internal Memory Audio Volume REM Contact Quality Monitor Serial Port RF Activation Port Force FX Electrosurgical Generator C User s Guide vii

10 Expansion Port Low Frequency (50 60 Hz) Leakage Current High Frequency (RF) Leakage Current Input Power Power Cord Specification Standards and IEC Classifications Class I Equipment (IEC ) Type CF Equipment (IEC )/Defibrillator Proof Liquid Spillage (IEC Clause 44.3) Electromagnetic Interference Electromagnetic Compatibility (IEC and IEC ) Voltage Transients (Emergency Generator Mains Transfer) Output Characteristics Maximum Output for Bipolar and Monopolar Modes Maximum Output for Ultrasonic Electrosurgery Available Power Settings in Watts Output Waveforms Output Power vs. Resistance Graphs Bipolar Graphs Monopolar Cut Graphs Monopolar Coag Graphs viii Force FX Electrosurgical Generator C User s Guide

11 Chapter 1 Introduction This chapter includes information about: Instant Response TM 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. Force FX Electrosurgical Generator C User s Guide 1-1

12 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 CUSA TM System 200 or CUSA EXcel TM and a CUSA handpiece with CUSA electrosurgical module (CEM TM ) 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 GSU TM 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. 1-2 Force FX Electrosurgical Generator C User s Guide

13 Monopolar Cut and Coag Modes Three bipolar modes are available: precise, standard, and macrobipolar. 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. 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 Introduction 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 Force FX Electrosurgical Generator C User s Guide 1-3

14 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 REM TM 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 Polyhesive TM 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. 1-4 Force FX Electrosurgical Generator C User s Guide

15 Ultrasonic Electrosurgery Electrodes Without the REM Safety Feature Warning Using a conventional patient return electrode without the REM safety feature will not activate the REM Contact Quality Monitoring System. Introduction 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. Force FX Electrosurgical Generator C User s Guide 1-5

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17 Chapter 2 Controls, Indicators and Receptacles This chapter describes the front and rear panels, including all controls, indicators, receptacles, the fuse drawer, and ports. Force FX Electrosurgical Generator C User s Guide 2-1

18 Front Panel Front Panel Recall button Pressing this button sets the generator to the most recently used mode and power settings. CEM indicator REM alarm indicator Bipolar controls Cut controls Coag controls Bipolar Instrument receptacle Power Switch This switch supplies power to the generator. Press ( ) to turn on the generator. Press (O) to turn off the generator. Monopolar 1/CEM Instrument receptacle Monopolar 2 Instrument receptacle Patient return electrode receptacle For monopolar electrosurgery, connect a patient return electrode to this receptacle. 2-2 Force FX Electrosurgical Generator C User s Guide

19 Bipolar Controls Bipolar Controls Bipolar display Shows the power setting, in watts, for the selected mode. Bipolar indicator When you activate bipolar, this indicator illuminates blue and an activation tone sounds. Power buttons Press Δ to increase the power. Press to decrease the power. Mode indicators Illuminate green when you press the corresponding mode button. Controls, Indicators and Receptacles Precise mode button Select for fine bipolar tissue desiccation. Macro mode button Select for macrobipolar output. Standard mode button Select for standard bipolar tissue desiccation. This is the default bipolar mode. Force FX Electrosurgical Generator C User s Guide 2-3

20 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. 2-4 Force FX Electrosurgical Generator C User s Guide

21 Bipolar Instrument Receptacle Monopolar Cut Controls Cut display Shows the power setting, in watts, for the selected mode. Cut indicator When you activate cut, this indicator illuminates yellow and an activation tone sounds. Mode indicators Illuminate green when you press the corresponding mode button. Power buttons Press Δ to increase the power. Press to decrease the power. Controls, Indicators and Receptacles Low mode button Select for a cut with little or no sparking. 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. Force FX Electrosurgical Generator C User s Guide 2-5

22 Monopolar Coag Controls Monopolar Coag Controls Coag display Shows the power setting, in watts, for the selected mode. Coag indicator When you activate coag, this indicator illuminates blue and an activation tone sounds. Mode indicators Illuminates green when you press the corresponding mode button. Power buttons Press Δ to increase the power. Press to decrease the power. Desiccate mode button Select to desiccate the area of tissue that is in direct contact with the active electrode. 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. 2-6 Force FX Electrosurgical Generator C User s Guide

23 Monopolar Instrument Receptacles Monopolar Instrument Receptacles Warning 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. You can connect a footswitching or handswitching monopolar instrument to the monopolar receptacles. Some footswitching instruments may require a single-pin adapter (E0502 Series or E0017), available from Covidien. Connect one monopolar instrument to the Monopolar 1/CEM Instrument receptacle: A single-pin footswitching instrument or a three-pin handswitching instrument or A four-pin CUSA handpiece with CEM nosecone. (The CEM indicator in the upper right of the front panel illuminates green. Refer to Connecting the CUSA Handpiece with CEM Nosecone on page 4-13.) Connect one monopolar instrument to the Monopolar 2 Instrument receptacle: Controls, Indicators and Receptacles A single-pin footswitching instrument or a three-pin handswitching instrument. Force FX Electrosurgical Generator C User s Guide 2-7

24 REM Alarm Indicator REM Alarm Indicator This indicator illuminates red until you properly apply a REM Polyhesive patient return electrode to the patient and connect it to the generator. Then the indicator illuminates green. (When you connect an electrode without the REM safety feature, the indicator does not illuminate.) If the REM system senses an alarm condition, the indicator flashes red until you correct the alarm condition then the indicator illuminates green. (If you are using a return electrode without the REM safety feature, the red indicator light is extinguished when you correct the alarm condition.) 2-8 Force FX Electrosurgical Generator C User s Guide

25 Rear Panel Rear Panel Volume control Power entry module Line fuse locator Option panel Bipolar Footswitch receptacle Controls, Indicators and Receptacles Monopolar Footswitch receptacles Equipotential grounding lug Use to connect the generator to earth ground. Force FX Electrosurgical Generator C User s Guide 2-9

26 Footswitch Receptacles Footswitch Receptacles The rear panel contains three footswitch receptacles: two for monopolar and one for bipolar. Monopolar Footswitch Receptacles You must connect a monopolar footswitch if you connect a monopolar footswitching instrument to the generator. Use only a Valleylab monopolar footswitch with the Force FX-C generator. Use of an incompatible footswitch may cause unexpected output. Connect a two-pedal Valleylab monopolar footswitch to the Monopolar 1 Footswitch receptacle. The connected footswitch activates monopolar output for the instrument that is connected to the Monopolar 1/CEM Instrument receptacle on the front panel. Connect a two-pedal monopolar footswitch to the Monopolar 2 Footswitch receptacle. The connected footswitch activates monopolar output for the instrument that is connected to the Monopolar 2 Instrument receptacle on the front panel. Bipolar Footswitch Receptacle You must connect a bipolar footswitch if you connect a bipolar footswitching instrument to the generator. Connect a single-pedal bipolar footswitch to the Bipolar Footswitch receptacle. The connected footswitch activates bipolar output for the instrument that is connected to the Bipolar Instrument receptacle on the front panel Force FX Electrosurgical Generator C User s Guide

27 Power Entry Module Power Entry Module The power entry module consists of a power cord receptacle and a fuse drawer. Fuse drawer The fuse drawer contains two fuses. The Force FX Electrosurgical Generator C Service Manual contains instructions for changing the fuses. Power cord receptacle Activation Tone Volume Control Turn to adjust the volume of the tones that sound when the generator is activated (activation tone). To ensure that the surgical team is alerted to inadvertent activation, these tones cannot be silenced. Controls, Indicators and Receptacles To increase the volume of activation tones, turn the knob clockwise. To decrease the volume, turn the knob counterclockwise. Force FX Electrosurgical Generator C User s Guide 2-11

28 Option Panel Option Panel A removable plate on the rear panel covers a serial port, an expansion port, and an RF (radio frequency) activation port. Remove this plate to obtain information through the RS-232 port or to install a peripheral device such as a Bipolar Current Monitor, but retain the original cover plate. After obtaining information or removing a peripheral device, reinstall the original cover plate. Notice Do not operate the Force FX-C generator without an appropriate cover plate in place. To review the technical specifications for each port, refer to Output Characteristics on page Expansion port Allows a connected device to receive information about the RF voltage and current being generated as well as signal the generator to halt RF output. Serial port Allows connection of a computer to the generator. You can obtain information about the generator using RS-232 communications protocol or change the default coag mode from Fulgurate to Desiccate or Spray. 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. Refer to the Force FX Electrosurgical Generator C Service Manual Force FX Electrosurgical Generator C User s Guide

29 Chapter 3 Patient and Operating Room Safety The safe and effective use of electrosurgery depends to a large degree upon factors solely under the control of the operator. There is no substitute for a properly trained and vigilant surgical team. It is important that the operating instructions supplied with this or any electrosurgical equipment be read, understood, and followed. Electrosurgery has been used safely in numerous procedures. Before starting any surgical procedure, the surgeon should be trained in the particular technique and surgical procedure to be performed, should be familiar with the medical literature related to the procedure and potential complications, and should be familiar with the risks versus the benefits of utilizing electrosurgery in the procedure. Force FX Electrosurgical Generator C User s Guide 3-1

30 General General Warning Always use the lowest output setting necessary that achieves the desired surgical effect. The active electrode should be utilized only for the minimum time necessary in order to lessen the possibility of unintended burn injury. Pediatric applications and/or procedures performed on small anatomic structures may require reduced power settings. The higher the current flow and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small structures. Use electrosurgery with caution in the presence of internal or external pacemakers. Interference produced by the use of electrosurgical devices can cause devices such as a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers. If the patient has an internal cardiac defibrillator (ICD), contact the ICD manufacturer for instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple activations of ICDs. Covidien recommends against the use of laparoscopic surgery on pregnant patients. Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken. Use by physicians without such training has resulted in serious, unintended patient injury, including bowel perforation and unintended, irreversible tissue necrosis. Hazardous Electrical Output This equipment is for use only by trained, licensed physicians. Caution Read all warnings, cautions, and instructions provided with this generator before using. 3-2 Force FX Electrosurgical Generator C User s Guide

31 General Fire/Explosion Danger Explosion Hazard Do not use electrosurgery in the presence of flammable anesthetics. Warning Fire/Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room: Flammable substances (such as alcohol-based skin prepping agents and tinctures) Naturally occurring flammable gases which may accumulate in body cavities such as the bowel Oxygen enriched atmospheres Oxidizing agents (such as nitrous oxide [N2O] atmospheres). The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire precautions at all times. When using electrosurgery in the same room with any of these substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where electrosurgery is performed. Fire Hazard with Oxygen Circuit Connections Warning Fire/Explosion Hazard Verify that all oxygen circuit connections are leak free before and during the use of electrosurgery. Verify that endotracheal tubes are leak free, and that the cuff is properly sealed to prevent oxygen leaks. Enriched oxygen atmospheres may result in fires and burns to patients or the surgical team. Electrosurgical Smoke Caution Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means a Patient and Operating Room Safety a. U.S. Department of Health and Human Services. National Institute for Occupational Safety and Health (NIOSH). Control of Smoke from Laser/Electric Surgical Procedures. HAZARD CONTROLS, Publication No , September, Force FX Electrosurgical Generator C User s Guide 3-3

32 General Inadvertent Radio Frequency Burns Warning Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar equipment) can provide a path for high frequency current even if the electrodes or probes are isolated at Hz, insulated, and/or battery operated. To reduce the risk of an inadvertent electrosurgical burn at the electrode or probe site, place the electrode and/or probe as far away as possible from the electrosurgical site and/or patient return electrode. Protective impedances (resistors or RF inductors) installed in the monitoring leads may reduce the risk of such burns. Consult the hospital biomedical engineer for further information. Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent electrosurgical burns may result. In some circumstances, potential exists for alternate site burns at points of skin contact (e.g., between the arm and the side of the body). This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point. Current passing through small skin to skin contact points is concentrated and may cause a burn. This is true for grounded, ground referenced, and isolated output generators. To reduce the potential for alternate site burns, do one or more of the following: Avoid skin-to-skin contact points, such as fingers touching leg, when positioning the patient. Place two to three inches of dry gauze between contact points to ensure that contact does not occur. Position the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin-to-skin contact areas. In addition, place patient return electrodes according to the manufacturer s instructions. Potential for alternate site burns increases if the return electrode is compromised. Covidien recommends the use of REM Polyhesive patient return electrodes and Covidien generators with the REM system. Ensure Proper Connections Caution Examine all accessories and connections to the electrosurgical generator before using. Ensure that the accessories function as intended. Improper connection may result in arcs, sparks, accessory malfunction, or unintended surgical effects. Accessories Warning Do not wrap the accessory cords or patient return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team. 3-4 Force FX Electrosurgical Generator C User s Guide

33 Before Surgery Servicing Warning Electric Shock Hazard Do not remove the cover. Contact authorized personnel for service. Notice Refer to this generator s service manual for maintenance recommendations and function and output power verification procedures. Before Surgery Active Accessories Warning Electric Shock Hazard Do not connect wet accessories to the generator. Connect accessories to the proper receptacle. Improper connection may result in inadvertent accessory activation or other potentially hazardous conditions. Follow the instructions provided with electrosurgical accessories for proper connection and use. Electric Shock Hazard Ensure that all accessories and adapters are correctly connected and that no metal is exposed. Caution Read the instructions, warnings, and cautions provided with electrosurgical accessories before using. Specific instructions are not included in this manual. Accessories must be connected to the proper receptacle type. In particular, bipolar accessories must be connected to the bipolar receptacle only. Improper connection of accessories may result in inadvertent generator activation or a REM Contact Quality Monitor alarm. Set power levels to the lowest setting before testing an accessory. Inspect accessories and cords (especially reusable accessories and cords) for breaks, cracks, nicks, or other damage before every use. If damaged, do not use. Failure to observe this precaution may result in injury or electrical shock to the patient or surgical team. Patient and Operating Room Safety Do not reuse or resterilize accessories labeled disposable or single use only. Force FX Electrosurgical Generator C User s Guide 3-5

34 Before Surgery Patient Return Electrodes Covidien recommends the use of REM Polyhesive patient return electrodes to maximize patient safety. Warning The safe use of monopolar electrosurgery requires proper placement of the patient return electrode. To avoid electrosurgical burns beneath the patient return electrode, follow all directions on the product package for proper return electrode placement and use. Do not cut a patient return electrode to reduce its size. Patient burns due to high current density may result. Do not apply a patient return electrode if only bipolar accessories are being used. Otherwise, the electrosurgical effect may not be limited to the tissue between the bipolar electrodes. Using a patient return electrode without the REM safety feature will not activate the REM Contact Quality Monitoring System. Covidien recommends against the use of capacitive pads. These pads do not activate the REM Contact Quality Monitoring System and require the use of higher power settings to achieve the desired surgical effect. This increases the possibility of alternate site burns. Shunt Cords Warning Some surgical instruments (e.g., colonoscopes) may allow substantial leakage current which could burn the surgeon. If the instrument manufacturer recommends the use of a shunt cord (s-cord) to direct the current back to the generator, you must also use a Covidien E0507B adapter. To avoid a REM alarm, you must use a REM Polyhesive patient return electrode with the E0507B adapter. Generator Warning Patient Safety Use the generator only if the self-test has been completed as described. Otherwise, inaccurate power outputs may result. 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. 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. 3-6 Force FX Electrosurgical Generator C User s Guide

35 During Surgery Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment (except a Force GSU unit or a Force Argon unit). These configurations are unstable and/or do not allow for adequate cooling. When using a smoke evacuator in conjunction with the electrosurgical generator, place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard. 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. Nonfunction of the generator may cause interruption of surgery. A backup generator should be available for use. 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. During Surgery Generator Power Settings Warning Confirm proper power settings before proceeding with surgery. Use the lowest power setting possible for the minimum time necessary to achieve the desired effect. Never increase the power settings without first checking both the active electrode and the patient return electrode and their connections. Use the active electrode or forceps only for the minimum time necessary to achieve the desired surgical effect in order to minimize the possibility of burns. This is especially true in pediatric and neonatal patients or in any patient where small appendages are involved. Patient and Operating Room Safety Caution The Force FX-C generator cuts effectively at power settings lower than previous models offered by Covidien. If the proper setting is not known, set the generator at a very low setting and cautiously increase the power until the desired effect is achieved. Force FX Electrosurgical Generator C User s Guide 3-7

36 During Surgery Forceps Notice Do not activate the generator until the forceps have made contact with the patient. Product damage may occur. Suction Coagulators Warning To avoid the possibility of a burn to the surgeon, always turn the generator off before bending or reshaping the coagulator suction tube. Ensure that the outside of the coagulator suction tube remains free of blood and mucus. Failure to clean the coagulator suction tube can allow electrical conductance by means of the contaminants that may result in patient burns. Do not immerse the suction coagulator handswitch mechanism in saline solution or other conductive fluids. Unintended activation may result. Contact with Metal Objects Warning Contact of the active electrode with any metal (such as hemostats, Gomco clamps, Kocher clamps, etc.) will greatly increase current flow and can result in unintended, catastrophic burn injury. While using electrosurgery, the patient should not be allowed to come into direct contact with grounded metal objects (e.g., surgical table frame, instrument table, etc.). If this is not possible during certain procedures (e.g., those in which noninsulated head frames are used), use extreme caution to maximize patient safety: Use the lowest power setting that achieves the desired effect. Place the patient return electrode as close to the surgical site as possible. Place dry gauze between the patient and the grounded object if possible. Continually monitor the contact point(s). 3-8 Force FX Electrosurgical Generator C User s Guide

37 During Surgery Active Accessories Warning 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, the surgical team, and flammable materials. Simultaneously activating suction/irrigation and electrosurgical current may result in increased arcing at the electrode tip, burns to unintended tissues, or shocks and burns to the surgical team. Some surgeons may elect to buzz the hemostat during surgical procedures. It is not recommended, and the hazards of such a practice probably cannot be eliminated. Burns to the surgeon s hands are possible. To minimize the risk: Do not lean on the patient, the table, or the retractors while buzzing the hemostat. Activate cut rather than coag. Cut has a lower voltage than coag. Use the lowest power setting possible for the minimum time necessary to achieve hemostasis. Activate the generator after the accessory makes contact with the hemostat. Do not arc to the hemostat. Firmly grasp as much of the hemostat as possible before activating the generator. This disperses the current over a larger area and minimizes the current concentration at the finger tips. Buzz the hemostat below hand level (as close as possible to the patient) to reduce the opportunity for current to follow alternate paths through the surgeon s hands. When using a stainless steel blade electrode, place the flat surface against the hemostat or other metal instrument. When using a coated or nonstick blade electrode, place the edge of the electrode against the hemostat or other metal instrument. When not using active accessories, place them in a holster or in a clean, dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns. Patient Return Electrodes Warning To avoid patient burns, ensure that the patient return electrode firmly contacts the skin. Always check the patient return electrode periodically and after the patient is repositioned and during procedures involving long periods of activation. Patient and Operating Room Safety Force FX Electrosurgical Generator C User s Guide 3-9

38 During Surgery Laparoscopic Procedures Warning For laparoscopic procedures, be alert to these potential hazards: Laparoscopic surgery may result in gas embolism due to insufflation of gas in the abdomen. The electrode tip may remain hot enough to cause burns after the electrosurgical current is deactivated. Inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient. Localized burns to the patient or physician may result from electrical currents carried through conductive objects (such as cannulas or scopes). Electrical current may be generated in conductive objects by direct contact with the active electrode, or by the active accessory (electrode or cable) being in close proximity to the conductive object. Do not use hybrid trocars that are composed of both metal and plastic components. For the operative channel, use all metal or all plastic systems. At no time should electrical energy pass through hybrid systems. Capacitive coupling of RF current may cause unintended burns. When using laparoscopic instrumentation with metal cannulas, the potential exists for abdominal wall burns to occur due to direct electrode contact or capacitive coupling of RF current. This is most likely to occur in instances where the electrosurgical generator is activated for extended periods at high power levels inducing high current levels in the cannula. Ensure that the insulation of disposable and reusable laparoscopic instrumentation is intact and uncompromised. Compromised insulation may lead to inadvertent metal-to-metal sparking and neuromuscular stimulation and/or inadvertent sparking to adjacent tissue. Do not activate electrodes while in contact with other instruments as unintended tissue injury may occur. Do not activate the generator in an open circuit condition. To reduce the chances of unintended burns, activate the generator only when the active electrode is near or touching the target tissue. Use the lowest power setting that achieves the desired surgical effect and use a low voltage waveform (pure cut or desiccate) to lessen the potential for the creation of capacitive currents. Carefully insert and withdraw active electrodes from cannulas to avoid possible injury to the patient or damage to the devices Force FX Electrosurgical Generator C User s Guide