Users Guide
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User’s Guide
Force FX™-8C Electrosurgical Generator with Instant Response™ Technology
Foreword 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 Valleylab Force FX™-8C Electrosurgical Generator only. Additional technical information is available in the Force FX™-8C Electrosurgical Generator Service Manual. Caution Federal (USA) law restricts this device to sale by or on the order of a physician. Equipment covered in this manual
Force FX™-8C Electrosurgical Generator with Instant Response™ Technology 110 V ~ Nominal / 230 V ~ Nominal (auto selected) Valleylab Part Number 1015208 Effective Date November 2008 Patent information
Protected by U.S. Pat. Nos. 5,190,517; 5,599,344; 5,628,745, and 6,203,541. Trademark acknowledgements
Valleylab™, ForceTriad™, Force FX™, Force EZ™, Force Argon™, LigaSure™, LigaSmart™, Smart™, Cool-tip™, TissueFect™, REM™, RFG3C™, OptiMumm™, SurgiStat™, EDGE™, AccuVac™, PolyHesive™, and Instant Response™ are trademarks of Valleylab. CUSA™, CUSA EXcel™, and CEM™ are trademarks of Integra LifeSciences Corporation or its subsidiary. Manufactured by
Valleylab a division of Tyco Healthcare Group LP, Boulder, Colorado 80301-3299 USA Made in China Printed in China* ©2008 Valleylab All rights reserved. European representative
Tyco Healthcare UK Ltd. Gosport, PO13 0AS, UK For information call
1-303-530-2300 Internet address
http://www.valleylab.com * Translations of this user’s guide printed in the USA.
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Force FX-8C User’s Guide
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.
Force FX-8C User’s Guide
Notice Indicates a hazard which may result in product damage.
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Warranty Valleylab, a division of Tyco Healthcare Group LP, warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period(s) set forth below. Valleylab’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 Distributor within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Valleylab’s satisfaction, that the product is defective. This warranty does not apply to any product, or part thereof, which has been repaired or altered outside Valleylab’s factory in a way so as, in Valleylab’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident. The warranty periods for Valleylab products are as follows: ForceTriad™ Energy Platform
One year from date of shipment
Electrosurgical Generators
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
Force Argon™ Units
One year from date of shipment
OptiMumm™ Smoke Evacuator
Two years from date of shipment
LigaSure™ 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
This warranty is in lieu of all other warranties, express or implied, including without limitation, the warranties of merchantability and fitness for a particular purpose, and of all other obligations or liabilities on the part of Valleylab. Valleylab neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Valleylab’s products. Notwithstanding any other provision herein or in any other document or
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Force FX-8C User’s Guide
communication, Valleylab’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Valleylab to the customer. There are no warranties which extend beyond the terms hereof. Valleylab disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or consequential damages. This 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 warranty is the District Court of the County of Boulder, State of Colorado, USA. Valleylab, its dealers, and representatives reserve the right to make changes in equipment built and/or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and/or sold by them.
Force FX-8C User’s Guide
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Force FX-8C User’s Guide
Table of Contents Foreword... ii Conventions Used in this Guide...iii Warranty...iv
Chapter 1. Introducing the Force FX-8C Electrosurgical Generator Instant Response Technology... 1-2 Bipolar Modes... 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... 1-4 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... 2-7 Rear Panel... 2-8 Footswitch Receptacles... 2-9 Monopolar Footswitch Receptacles... 2-9 Bipolar Footswitch Receptacle... 2-9 Power Entry Module... 2-9 Activation Tone Volume Control... 2-10 Option Panel... 2-10
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 Before Surgery... 3-5 Active Accessories... 3-5 Patient Return Electrodes... 3-5 Shunt Cords... 3-6
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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... 3-8 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... 4-2 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 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 Typical Power Settings... 5-5 Activating the Surgical Instrument... 5-6 Activation Indicators... 5-6 Adjusting the Volume of Activation Tones... 5-6 Responding to Alarms... 5-7 REM Alarm... 5-7 Non-REM Patient Return Electrode Alarm... 5-7
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System Alarm... 5-7
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... 7-8
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... 9-2 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 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... 9-7 Standards and IEC Classifications... 9-8 Class I Equipment (IEC 60601-1)... 9-8 Type CF Equipment (IEC 60601-1)/Defibrillator Proof... 9-8 Liquid Spillage (IEC 60601-2-2 Clause 44.3)... 9-9 Electromagnetic Interference... 9-9 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)... 9-9 Voltage Transients (Emergency Generator Mains Transfer)... 9-9 Output Characteristics... 9-10 Maximum Output for Bipolar and Monopolar Modes... 9-10 Maximum Output for Ultrasonic Electrosurgery... 9-10 Available Power Settings in Watts... 9-11
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Output Waveforms... 9-13 Output Power vs. Resistance Graphs... 9-15 Bipolar Graphs... 9-15 Monopolar Cut Graphs... 9-20 Monopolar Coag Graphs... 9-25
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List of Figures
Force FX-8C User’s Guide
Figure 4-1.
Connection for bipolar or macrobipolar surgery using footswitch activation and a handswitching or footswitching instrument 4-5
Figure 4-2.
Connection for bipolar or macrobipolar surgery using a handswitching instrument 4-6
Figure 4-3.
Connection for monopolar surgery using footswitch activation and a footswitching or handswitching instrument-using Monopolar 1 Footswitch receptacle and Monopolar 1/CEM Instrument receptacle 4-8
Figure 4-4.
Connection for monopolar surgery using footswitch activation and a footswitching or handswitching instrument-using Monopolar 2 Footswitch receptacle and Monopolar 2 Instrument receptacle 4-8
Figure 4-5.
Connection for monopolar surgery using handswitch activation and a monopolar handswitching instrument-using either Monopolar Instrument receptacle 4-9
Figure 4-6.
Connection for simultaneous coag using two handswitching instruments 4-12
Figure 4-7.
Connection for simultaneous coag using two footswitching instruments 4-12
Figure 4-8.
Connection for combined monopolar/ultrasonic surgery 4-14
Figure 9-1.
Output power versus impedance for Precise bipolar mode 9-15
Figure 9-2.
Precise bipolar mode-output power vs. peak voltage 9-15
Figure 9-3.
Output power vs. generator settings Precise bipolar mode
Figure 9-4.
Output power versus impedance for Standard bipolar mode
Figure 9-5.
Standard bipolar mode-output power vs. peak voltage 9-17
Figure 9-6.
Output power vs. generator settings Standard bipolar mode 9-17
Figure 9-7.
Output power versus impedance for Macrobipolar mode 9-18
Figure 9-8.
Macrobipolar mode-output power vs. peak voltage 9-18
Figure 9-9.
Output power vs. generator settings Macrobipolar mode
Figure 9-10.
Output power versus impedance for Low cut mode 9-20
Figure 9-11.
Low cut mode-output power vs. peak voltage
Figure 9-12.
Output power vs. generator settings Low cut mode 9-21
Figure 9-13.
Output power versus impedance for Pure cut mode 9-21
Figure 9-14.
Pure cut mode-output power vs. peak voltage
Figure 9-15.
Output power vs. generator settings Pure cut mode
Figure 9-16.
Output power versus impedance for Blend cut mode 9-23
Figure 9-17.
Blend cut mode-output power vs. peak voltage
Figure 9-18.
Output power vs. generator settings Blend cut mode 9-24
Figure 9-19.
Output power versus impedance for Desiccate 1 coag mode
Figure 9-20.
Desiccate 1 coag mode-output power vs. peak voltage 9-25
Figure 9-21.
Output power vs. generator settings Desiccate 1 coag mode 9-26
Figure 9-22.
Output power versus impedance for Desiccate 2 coag mode
9-16 9-16
9-19
9-20
9-22 9-22
9-23 9-25
9-26
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Figure 9-23.
Desiccate 2 coag mode-output power vs. peak voltage 9-27
Figure 9-24.
Output power vs. generator settings Desiccate 2 coag mode 9-27
Figure 9-25.
Output power versus impedance for Desiccate 3 coag mode
Figure 9-26.
Desiccate 3 coag mode-output power vs. peak voltage 9-28
Figure 9-27.
Output power vs. generator settings Desiccate 3 coag mode 9-29
Figure 9-28.
Output power versus impedance for Fulgurate coag mode
Figure 9-29.
Fulgurate coag mode-output power vs. peak voltage 9-30
Figure 9-30.
Output power vs. generator settings Fulgurate coag mode 9-30
Figure 9-31.
Output power versus impedance for LCF Fulgurate mode 9-31
Figure 9-32.
LCF Fulgurate mode-output power vs. peak voltage 9-31
Figure 9-33.
Output power vs. generator settings LCF Fulgurate mode
Figure 9-34.
Output power versus impedance for Spray coag mode
Figure 9-35.
Spray coag mode-output power vs. peak voltage 9-33
Figure 9-36.
Output power vs. generator settings Spray coag mode 9-33
9-28
9-29
9-32
9-32
Force FX-8C User’s Guide
Chapter
1
Introducing the Force FX-8C Electrosurgical Generator
This chapter includes the following information: •
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.
Force FX-8C User’s Guide
1-1
Instant Response Technology
The Valleylab Force FX-8C Electrosurgical Generator 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)
•
Three monopolar cut modes: low, pure, and blend
•
Three monopolar coag modes: desiccate (low), fulgurate (medium), and spray (high)
•
Support for simultaneous coagulation
•
The Valleylab REM Contact Quality Monitoring System
•
Support for ultrasonic electrosurgery using the CUSA System 200 or CUSA EXcel system 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 GSU system and Force Argon system compatibility
Valleylab electrosurgical generators, patient return electrodes, and active accessories are designed to work as a system. Valleylab 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-8C 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-8C User’s Guide
Bipolar Modes
Delicate tissue requires less heat to desiccate quickly. The Force FX-8C 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. 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.
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 shallower and the tissue area is larger than with the fulgurate mode.
For details about the output characteristics, refer to Chapter 9, Technical Specifications.
Force FX-8C User’s Guide
1-3
Introducing the Force FX-8C Electrosurgical Generator
Bipolar Modes
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 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-8C generator uses the Valleylab REM Contact Quality Monitoring System to monitor the quality of electrical contact between the patient return electrode and the patient. The REM system is designed to 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 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:
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•
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.
Force FX-8C User’s Guide
Ultrasonic Electrosurgery
Warning Using a conventional patient return electrode without the REM safety feature will not activate the Valleylab 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-8C 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.
Force FX-8C User’s Guide
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Introducing the Force FX-8C Electrosurgical Generator
Electrodes Without the REM Safety Feature
1-6
Force FX-8C User’s Guide
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-8C User’s Guide
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Front Panel
Front Panel 1
11
3
2
10
9
4
8
5
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 REM alarm indicator ⑥ CEM 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.
2-2
•
To turn on the generator, press (|).
•
To turn off the generator, press (O).
Force FX-8C User’s Guide