Users Guide
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User’s Guide
Force FX
TM
Electrosurgical Generator 8CAS
User’s Guide
Force FX
TM
Electrosurgical Generator 8CAS
1013091
Preface
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 using the Covidien Force FX™ Electrosurgical Generator 8CAS only. Additional technical information is available in the Force FX-8CAS Electrosurgical Generator Service Manual. Equipment covered in this manual Force FX Electrosurgical Generator 8CAS 110 V ~ Nominal / 230 V ~ Nominal (auto selected)
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. Important Indicates an operating tip or maintenance suggestion. Notice Indicates a hazard which may result in product damage.
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Force FX Electrosurgical Generator 8CAS User’s Guide
Limited Warranty
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™ Energy Platform
One year from date of shipment
Electrosurgical Generators
One year from date of shipment
Cool-tip™ RFA Generator
One year from date of shipment
Evident™ MWA Generator
One year from date of shipment
RFG-3C™ Plus Lesion Generator
One year from date of shipment
LigaSure™ Vessel Sealing System
One year from date of shipment
LigaSure™ 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
Valleylab™ Argon Gas Delivery Unit II
One year from date of shipment
RapidVac™ Smoke Evacuator
One year from date of shipment
LigaSure™ Sterile Single Use Items
Sterility only as stated on packaging
Cool-tip™ 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
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iii
Limited Warranty
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 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 8CAS 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... 1-3 Autobipolar Mode... 1-3 Monopolar Cut and Coag Modes... 1-3 Simultaneous Coag... 1-4 REM Contact Quality Monitoring System... 1-4 How the REM System Works... 1-5 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
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Ensure Proper Connections... 3-4 Accessories... 3-4 Servicing... 3-5 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 Changing the Desiccate Mode... 4-11 Simultaneous Coag... 4-12 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
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
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Force FX Electrosurgical Generator 8CAS User’s Guide
Changing the Power Setting... 5-3 Techniques for Keeping Power Settings Low... 5-4 Typical Power Settings... 5-5 Activating the Surgical Instrument... 5-6 Autobipolar Activation... 5-6 Autobipolar Setup Mode... 5-7 Activation Indicators... 5-9 Adjusting the Volume of Activation Tones... 5-10 Responding to Alarms... 5-10 REM Alarm... 5-10 Non-REM Patient Return Electrode Alarm... 5-10 System Alarm... 5-11
Chapter 6. After Surgery Preparing the Generator for Reuse... 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 Service Centers... 8-4
Chapter 9. Technical Specifications Performance Characteristics... 9-2 General... 9-2 Dimensions and Weight... 9-2 Operating Parameters... 9-3 Transport and Storage... 9-3 Duty Cycle... 9-3 Internal Memory... 9-4 Audio Volume... 9-4 REM Contact Quality Monitor... 9-5 Serial Port... 9-6 RF Activation Port... 9-6
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Expansion Port... 9-6 Low Frequency (50–60 Hz) Leakage Current... 9-7 High Frequency (RF) Leakage Current... 9-7 Input Power... 9-8 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)... 9-11 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... 9-14 Output Power vs. Resistance Graphs... 9-16 Bipolar Graphs... 9-16 Monopolar Cut Graphs... 9-23 Monopolar Coag Graphs... 9-29
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Force FX Electrosurgical Generator 8CAS User’s Guide
Chapter 1 Introduction
This chapter includes information about •
Instant ResponseTM 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 Force FX Electrosurgical Generator 8CAS with Instant Response Technology is an isolated output electrosurgical generator that provides 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)
•
Autobipolar mode
•
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 system and a CUSA handpiece with 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
•
Force GSU System and Argon Gas Delivery Unit II compatibility.
TM
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-8CAS 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), power setting, and level of tissue resistance. The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking.
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Force FX Electrosurgical Generator 8CAS User’s Guide
Bipolar Modes
Delicate tissue requires less heat to desiccate quickly. The Force FX-8CAS 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.
Introduction
Bipolar 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. The 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 Chapter 9, Technical Specifications.
Autobipolar Mode The autobipolar feature senses tissue impedance between the two bipolar electrodes, then uses the impedance information to automatically start or stop bipolar RF keying. Optionally, the user may choose between footswitch start and auto start, or program a delay between auto start and RF activation. The autobipolar function is available only in the Precise and Standard bipolar modes on the Force FX-8CAS generator. It is not available in the Macrobipolar mode.
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.
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REM Contact Quality Monitoring System
•
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 shallower and the tissue area is larger than with the fulgurate mode.
For details about the output characteristics, refer to Chapter 9, Technical Specifications.
Simultaneous Coag If you connect an instrument to each monopolar receptacle and activate them for coag simultaneously, each receives a percentage of the power set for the particular coag mode, dependent on the tissue resistance sensed by the generator at each surgical site. The Force FX-8CAS generator will only activate in fulgurate and spray coag modes. 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. For the Force FX-8CAS generator, only Desiccate 1 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-8CAS generator uses the REM Contact Quality Monitoring System to monitor the quality of electrical contact between the patient return electrode and the patient. The REMTM 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.
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Force FX Electrosurgical Generator 8CAS User’s Guide
Ultrasonic Electrosurgery
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.
Introduction
How the REM System Works
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.
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.
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-8CAS generator works in conjunction with the CUSA System 200 and CUSA EXcel system 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 1 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.
Force FX Electrosurgical Generator 8CAS User’s Guide
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Front Panel
Front Panel 1
2
11
4
3
10
9
5
8
6
7
① Recall button Pressing this button sets the generator to the most recently used mode and power settings.
② Bipolar controls ③ Cut controls ④ Coag controls ⑤ CEM indicator ⑥ REM alarm indicator ⑦ Patient return electrode receptacle For monopolar electrosurgery, connect a patient return electrode to this receptacle.
⑧ Monopolar 2 instrument receptacle ⑨ Monopolar 1/CEM instrument receptacle ⑩ Bipolar instrument receptacle ⑪ Power switch This switch supplies power to the generator.
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•
To turn on the generator, press (|).
•
To turn off the generator, press (O).
Force FX Electrosurgical Generator 8CAS User’s Guide
Bipolar Controls
Bipolar Controls 1
8
2
7
6
5
4
① Bipolar indicator When you activate bipolar, this indicator illuminates blue and an activation tone sounds.
Controls, Indicators, and Receptacles
3
② Autobipolar Button Select for autobipolar mode. Note: When this mode is selected, the leftmost Bipolar digit will display either an uppercase “A” or “P” indicating whether keying is automatic (A) or accomplished through a footswitch pedal (P).
③ Power buttons Press ▲ to increase the power. Press ▼ to decrease the power.
④ Macro mode button Select for macrobipolar output.
⑤ Standard mode button Select for standard bipolar tissue desiccation. This is the default bipolar mode.
⑥ Precise mode button Select for fine bipolar tissue desiccation.
⑦ Mode indicators Illuminate green when you press the corresponding mode button.
⑧ Bipolar display Shows the power setting, in watts, for the selected 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 Instrument 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 instrument 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 8CAS User’s Guide
Monopolar Cut Controls
Monopolar Cut Controls 1
7
2 6
4
3
① Cut indicator
Controls, Indicators, and Receptacles
5
When you activate cut, this indicator illuminates yellow and an activation tone sounds.
② Power buttons Press ▲ to increase the power. Press ▼ to decrease the power.
③ Blend mode button Select for slower cutting and additional hemostasis.
④ Pure mode button Select for an even cut with little or no hemostasis. This is the default monopolar cut mode.
⑤ Low mode button Select for a cut with little or no sparking.
⑥ Mode indicators Illuminate green when you press the corresponding mode button.
⑦ Cut display Shows the power setting, in watts, for the selected mode.
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Monopolar Coag Controls
Monopolar Coag Controls 1
7
2 6
5
4
3
① Coag indicator When you activate coag, this indicator illuminates blue and an activation tone sounds.
② Power buttons Press ▲ to increase the power. Press ▼ to decrease the power.
③ 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.
④ 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. For details about this additional fulgurate mode, LCF fulgurate, refer to Chapter 4, Before Surgery. Fulgurate 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.
⑤ Desiccate mode button Select to desiccate the area of tissue that is in direct contact with the active electrode.
⑥ Mode indicators Illuminate green when you press the corresponding mode button.
⑦ Coag display Shows the power setting, in watts, for the selected mode.
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Force FX Electrosurgical Generator 8CAS User’s Guide