User's Guide
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User’s Guide Force EZ™-C 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 EZ™-C Electrosurgical Generator only. Additional technical information is available in the Force EZ™-C 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 EZ™-C Electrosurgical Generator with Instant Response™ Technology 100–120 V ~ (110 V ~ nominal), 220–240 V ~ (230 V ~ nominal) – (user selectable) Valleylab Part Number 1015380 Effective Date November 2008 Trademark acknowledgements Force FX™. Force EZ™, Force Argon™, Force GSU™, SurgiStat™, REM™, EDGE™, AccuVac™, PolyHesive™, and Instant Response™ are trademarks of Valleylab. Patent information Protected by U.S. Pat. Nos. 5,599,344; and 5,628,745. Manufactured for Valleylab a division of Tyco Healthcare Group LP Boulder, Colorado 80301-3299 USA For information call 1-303-530-2300 European Representative Tyco Healthcare UK Ltd. Gosport, PO13 0AS, UK Made in China Printed in China ©2008 Valleylab All rights reserved.
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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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Warranty iv
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 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.
Force EZ-C User’s Guide
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.
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Table of Contents Foreword............................................................................................................................................... ii Conventions Used in this Guide........................................................................................................... iii Warranty .............................................................................................................................................. iv List of Figures ...................................................................................................................................... xi Chapter 1. Introducing the Force EZ-C Electrosurgical Generator Instant Response Technology ........................................................................................................... 1-2 Bipolar Modes .................................................................................................................................... 1-3 Monopolar Cut and Coag Modes ....................................................................................................... 1-3 Cut Modes ................................................................................................................................. 1-3 Coag Modes .............................................................................................................................. 1-3 REM Contact Quality Monitoring System........................................................................................... 1-4 How the REM System Works .................................................................................................... 1-4 Electrodes Without the REM Safety Feature ............................................................................ 1-4 Special Features ................................................................................................................................ 1-5 Low (Desiccate) Coag Settings ................................................................................................. 1-5 High (Fulgurate) Coag Settings................................................................................................. 1-5 Recall of Most Recently Used Modes and Power Settings ....................................................... 1-5 Default Coag Mode ................................................................................................................... 1-5 Original Default Settings ........................................................................................................... 1-6 Chapter 2. Controls, Indicators, and Receptacles Front Panel ........................................................................................................................................ 2-2 Bipolar Controls ................................................................................................................................. 2-3 Bipolar Instrument Receptacle........................................................................................................... 2-4 Footswitch Receptacle, Button, and Indicators.................................................................................. 2-4 Monopolar Cut Controls ..................................................................................................................... 2-5 Monopolar Coag Controls .................................................................................................................. 2-6 Monopolar Instrument Receptacles ................................................................................................... 2-7 Monopolar Footswitching Accessory Receptacle...................................................................... 2-7 Monopolar Footswitching or Handswitching Instrument Receptacle......................................... 2-7 REM Alarm Indicator.......................................................................................................................... 2-7 Rear Panel ......................................................................................................................................... 2-8 Footswitch Receptacles ..................................................................................................................... 2-9 Monopolar Footswitch Receptacle ............................................................................................ 2-9 Bipolar Footswitch Receptacle .................................................................................................. 2-9 Power Entry Module........................................................................................................................... 2-9 Activation Tone Volume Control ...................................................................................................... 2-10 Option Panel .................................................................................................................................... 2-10
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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.......................................................................................................... 3-6 Shunt Cords............................................................................................................................... 3-6 Generator .................................................................................................................................. 3-7 During Surgery ................................................................................................................................... 3-8 Generator Power Settings ......................................................................................................... 3-8 Forceps...................................................................................................................................... 3-8 Suction Coagulators .................................................................................................................. 3-9 Contact with Metal Objects........................................................................................................ 3-9 Active Accessories .................................................................................................................. 3-10 Patient Return Electrodes........................................................................................................ 3-11 Laparoscopic Procedures ........................................................................................................ 3-11 After Surgery .................................................................................................................................... 3-12 Chapter 4. Before Surgery Quick Setup Instructions .................................................................................................................... 4-2 Setting Up the Generator ................................................................................................................... 4-3 Preparing for Bipolar Surgery............................................................................................................. 4-5 Connections for Bipolar 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 Set the Cut and Coag Output .................................................................................................. 4-11 Setting Up the Special Features ...................................................................................................... 4-12 Entering the Setup Mode......................................................................................................... 4-12 Exiting the Setup Mode ........................................................................................................... 4-13
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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 ..................................................................................................... 5-4 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 ......................................................................................... 5-7 Responding to Alarms........................................................................................................................ 5-7 REM Alarm ................................................................................................................................ 5-7 Non-REM Patient Return Electrode Alarm ................................................................................ 5-7 System Alarm ............................................................................................................................ 5-8 Calling the Valleylab Clinical Information Hotline............................................................................... 5-8 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 Checking for Obvious Problems................................................................................................ 7-2 Performing a Detailed Inspection .............................................................................................. 7-3 Applying Additional REM Patient Return Electrodes................................................................. 7-3 Correcting Malfunctions ..................................................................................................................... 7-5 Responding to System Alarms........................................................................................................... 7-9 Chapter 8. Maintenance and Repair Responsibility of the Manufacturer..................................................................................................... 8-2 Routine Maintenance ......................................................................................................................... 8-2 Returning the Generator for Service .................................................................................................. 8-3 Service Center ................................................................................................................................... 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
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Internal Memory......................................................................................................................... 9-3 Audio Volume ............................................................................................................................ 9-4 REM Contact Quality Monitor .................................................................................................... 9-4 Serial Port.................................................................................................................................. 9-5 RF Activation Port...................................................................................................................... 9-5 Low Frequency (50–60 Hz) Leakage Current ........................................................................... 9-5 High Frequency (RF) Leakage Current ..................................................................................... 9-6 Input Power ............................................................................................................................... 9-6 Power Cord Specification .......................................................................................................... 9-7 Standards and IEC Classifications ..................................................................................................... 9-7 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) ............................................................................ 9-8 Electromagnetic Interference..................................................................................................... 9-8 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ......................................... 9-8 Voltage Transients (Emergency Generator Mains Transfer) ..................................................... 9-9 Output Characteristics........................................................................................................................ 9-9 Maximum Output for Force EZ-C Generator Modes ................................................................. 9-9 Available Power Settings in Watts ............................................................................................. 9-9 Output Waveforms................................................................................................................... 9-11 Output Power vs. Resistance Graphs .............................................................................................. 9-12 Bipolar Graph .......................................................................................................................... 9-12 Monopolar Cut Graphs ............................................................................................................ 9-13 Monopolar Coag Graphs ......................................................................................................... 9-14 Output Power vs. Generator Settings .............................................................................................. 9-17
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List of Figures
Figure 4-1. Bipolar connections (footswitch activation from the Bipolar Footswitch receptacle on the rear panel) 4-5
Figure 4-2. Bipolar connections (footswitch activation from the Footswitch receptacle on the front panel) 4-6 Figure 4-3. Bipolar connection (handswitching instrument) 4-6 Figure 4-4. Monopolar connections (handswitching instrument) 4-8 Figure 4-5. Monopolar connections (footswitch activation from the Monopolar Footswitch receptacle on the rear panel) 4-8 Figure 4-6. Monopolar connections (footswitch activation from the Footswitch receptacle on the front panel) 4-9
Figure 7-1. Applying a second REM electrode 7-3 Figure 7-2. Applying a third REM electrode 7-4 Figure 7-3. Attaching two REM electrodes to the generator simultaneously 7-4 Figure 9-1. Standard Bipolar mode — load resistance vs. output power 9-12 Figure 9-2. Pure mode — load resistance vs. output power 9-13 Figure 9-3. Blend mode — load resistance vs. output power 9-13 Figure 9-4. Low 1 (Desiccate) mode — load resistance vs. output power 9-14
Figure 9-5. Low 2 (Desiccate) mode — load resistance vs. output power 9-14 Figure 9-6. Low 3 (Desiccate) mode — load resistance vs. output power 9-15 Figure 9-7. High 1 (Fulgurate) mode — load resistance vs. output power 9-15 Figure 9-8. High 2 (Fulgurate) mode — load resistance vs. output power 9-16 Figure 9-9. Standard Bipolar mode @ 100 ohms — generator setting vs. output power Figure 9-10. Standard Bipolar mode — peak voltage vs. output power 9-17 Figure 9-11. Pure mode @ 300 ohms — generator setting vs. output power 9-18
9-17
Figure 9-12. Pure mode — peak voltage vs. output power 9-18 Figure 9-13. Blend mode @ 300 ohms — generator setting vs. output power 9-19 Figure 9-14. Blend mode — peak voltage vs. output power 9-19 Figure 9-15. Low 1 (Desiccate) mode @ 500 ohms — generator setting vs. output power Figure 9-16. Low 1 (Desiccate) mode — peak voltage vs. output power 9-20 Figure 9-17. Low 2 (Desiccate) mode @ 300 ohms— generator setting vs. output power Figure 9-18. Low 2 (Desiccate) mode — peak voltage vs. output power 9-21
9-20 9-21
Figure 9-19. Low 3 (Desiccate) mode @ 300 ohms— generator setting vs. output power Figure 9-20. Low 3 (Desiccate) mode — peak voltage vs. output power 9-22 Figure 9-21. High 1 (Fulgurate) mode @ 500 ohms— generator setting vs. output power
9-22 9-23
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Figure 9-22. High 1 (Fulgurate) mode — peak voltage vs. output power 9-23 Figure 9-23. High 2 (Fulgurate) mode @ 500 ohms— generator setting vs. output power Figure 9-24. High 2 (Fulgurate) mode — peak voltage vs. output power 9-24
9-24
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1 C h a p t e r Introducing the Force EZ-C 1 Electrosurgical Generator This chapter includes the following information: • Instant Response technology • Bipolar modes • Monopolar cut and coag modes • REM Contact Quality Monitoring System • Special features of the Force EZ-C generator 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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Instant Response Technology The Valleylab Force EZ-C 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 • Standard bipolar mode • Two monopolar cut modes: pure and blend • Two monopolar coag modes: low (desiccate) and high (fulgurate) • The Valleylab REM Contact Quality Monitoring System • Handswitch or footswitch activation • User selectable coag settings • User selectable default settings • Adjustable activation tone volume • An RF activation port and RS-232 serial port • Force Argon II system compatibility • Tilt support provided by the bottom mounted handle or use with Valleylab carts 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 EZ-C generator automatically senses resistance and adjusts the output voltage, current, and power to maintain a consistent effect across different tissue density. This adjustment is based on the selected mode, power setting, and level of tissue resistance. The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking. This technology applies to the standard bipolar mode, the cut modes, and the low 2 and low 3 coag settings. It does not apply to the low 1, high 1, and high 2 coag settings.
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Introducing the Force EZ-C Electrosurgical Generator
Bipolar Modes
Bipolar Modes The Force EZ-C generator provides a standard bipolar mode usable for most bipolar applications. Delicate tissue requires less heat to desiccate quickly. The 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. For details about the bipolar output characteristics, refer to Chapter 9, Technical Specifications.
Monopolar Cut and Coag Modes Cut Modes Two cut modes—pure and blend—allow a wide range of power settings necessary to perform diverse surgical procedures. • Pure provides an even cut with little or no hemostasis. It offers good cutting performance over a wide range of tissue resistance • Blend provides cutting ability with additional hemostasis Coag Modes Two coagulation modes help control the size of the area and the depth of penetration during tissue coagulation. The low (desiccate) mode has three settings; the high (fulgurate) mode, two settings. You can select, as default settings, one low setting and one high setting. For a description of each setting, refer to Special Features in this chapter. • Low (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. • High (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. For details about the output characteristics, refer to Chapter 9, Technical Specifications.
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REM Contact Quality Monitoring System 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 EZ-C 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 and lowering the baseline resistance if the contact resistance drops. 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 baseline measurement Electrodes Without the REM Safety Feature Warning Using a 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.
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Introducing the Force EZ-C Electrosurgical Generator
Special Features
Special Features
Five special features allow customizing the Force EZ-C generator. You can access these features only in the setup mode. For details on selecting these features, refer to Chapter 4, Setting Up the Special Features.
Low (Desiccate) Coag Settings The low (desiccate) coag mode provides three settings with subtle differences in output characteristics: • Low 1 is appropriate for the majority of surgical procedures. It provides tissue desiccation with a minimal tendency to cut or spark. • Low 2 produces tissue desiccation and further reduces the chance of cutting or sparking by using the lowest possible voltage (200 Vrms). • Low 3 uses a slightly higher voltage (300 Vrms) than the low 2 setting, but offers comparable desiccation.
High (Fulgurate) Coag Settings The high (fulgurate) coag mode provides two settings: • High 1 produces coagulation of smaller areas without touching the electrode tip to the tissue. • High 2 produces coagulation of larger areas without touching the electrode tip to the tissue.
Recall of Most Recently Used Modes and Power Settings When you activate this feature, the generator will, when turned on, revert to the most recently used modes and power settings.
Default Coag Mode
Important The default coag mode feature is available only when the most recently used modes and power settings feature is turned off.
You can select either low (desiccate) or high (fulgurate) as the default coag mode for the Force EZ-C generator. Each time you turn on the generator, it automatically selects the default coag mode.
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Special Features
Original Default Settings This feature resets the generator to the original default setting for each mode, power setting, and special feature. The next time you turn on the generator, it automatically selects the original default settings.
Mode or Feature
Original Default Setting
Monopolar
Pure
Coag
High (fulgurate)
Low (desiccate) coag setting
1 (low 1)
High (fulgurate) coag setting
2 (high 2)
Last used modes and power settings 1 (on)
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2 C h a p t e r Controls, Indicators, 2 and Receptacles This chapter describes the front and rear panels, including all controls, indicators, receptacles, the fuse drawer, and ports.
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Front Panel Front Panel
Bipolar controls
Footswitch indicators
REM alarm indicator
Cut controls
Coag controls
Footswitch
Bipolar instrument
receptacle
receptacle
Footswitch
selector button
Power switch
This switch supplies
power to the generator.
To turn on the generator, press (|). To turn off the generator, press (O).
Monopolar
footswitching
accessory receptacle
Monopolar footswitching or
handswitching
instrument
receptacle
Patient return electrode receptacle For monopolar electrosurgery, connect a patient return electrode to this receptacle.
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Bipolar Controls Bipolar display Shows the power setting, in watts, for standard bipolar mode.
Bipolar Controls Bipolar indicator When you activate bipolar, this bar illuminates blue and an activation tone sounds.
Bipolar Power Control Knob To increase (+) the power, turn the knob clockwise. To decrease (–) the power, turn the knob counterclockwise.
Controls, Indicators, and Receptacles
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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. Footswitch Receptacle, Button, and Indicators Connect a two-pedal Valleylab monopolar footswitch to this receptacle. Press the Footswitch Selector button to select bipolar or accessory output. Use only a Valleylab monopolar footswitch with the Force EZ-C generator. Use of an incompatible footswitch may cause unexpected output. When the left arrow indicator illuminates green, the footswitch activates the instrument connected to the Bipolar Instrument receptacle. When the right arrow indicator illuminates green, the footswitch activates the instrument connected to the Monopolar Footswitching Accessory receptacle. The footswitch will not activate an instrument connected to the Monopolar Footswitching or Handswitching Instrument receptacle.
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Monopolar Cut Controls Cut display Shows the power setting, in watts, for cut output.
Monopolar Cut Controls Cut indicator When you activate cut, this bar illuminates yellow and an activation tone sounds. Pure Button Select for an even cut with little or no hemostasis.
Blend Button Select for slower cutting and additional hemostasis.
Cut Power Control Knob To increase (+) the power, turn the knob clockwise. To decrease (–) the power, turn the knob counterclockwise.
Controls, Indicators, and Receptacles
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Monopolar Coag Controls Monopolar Coag Controls
Coag display Shows the power setting, in watts, for coag output.
Coag indicator When you activate the generator in coag mode, this bar illuminates blue and an activation tone sounds. Low (Desiccate) Button Select to desiccate the area of tissue that is in direct contact with the active electrode. High (Fulgurate) Button Select to fulgurate an area of tissue with a spray of sparks.
Coag Power Control Knob To increase (+) the power, turn the knob clockwise. To decrease (–) the power, turn the knob counterclockwise.
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Controls, Indicators, and Receptacles
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. Monopolar Footswitching Accessory Receptacle Connect a monopolar footswitching instrument with a single-pin connector to this receptacle. To activate the instrument, connect a monopolar footswitch to the front panel. Monopolar Footswitching or Handswitching Instrument Receptacle You can connect either a handswitching instrument (three-pin connector) or a footswitching instrument (single-pin connector) to this receptacle. To activate a footswitching instrument, connect a monopolar footswitch to the rear panel. Some footswitching instruments may require a single-pin adapter (E0502 Series) or E0017, available from Valleylab. REM Alarm Indicator This indicator illuminates red until you properly apply a REM 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.)
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Rear Panel Rear Panel Volume control
Power entry module
Bipolar Footswitch receptacle Monopolar Footswitch receptacle
Option panel
Equipotential grounding lug Use to connect the generator to earth ground.
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Controls, Indicators, and Receptacles
Footswitch Receptacles
Footswitch Receptacles
Monopolar Footswitch Receptacle Connect a two-pedal Valleylab monopolar footswitch to this receptacle if you connect an instrument to the Monopolar Footswitching or Handswitching Instrument receptacle on the front panel. Use only a Valleylab monopolar footswitch with the Force EZ-C generator. Use of an incompatible footswitch may cause unexpected output. The footswitch will not activate instruments connected to the Bipolar Instrument or Monopolar Footswitching Accessory receptacles on the front panel.
Bipolar Footswitch Receptacle Connect a single-pedal bipolar footswitch to this receptacle if you connect an instrument to the Bipolar Instrument receptacle on the front panel. The footswitch will not activate instruments connected to the Monopolar Instrument or Monopolar Footswitching Accessory receptacles on the front panel.
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. Refer to the Force EZ-C Electrosurgical Generator Service Manual for instructions on changing the fuses. Power cord receptacle
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Activation Tone Volume Control 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. To increase the volume of activation tones, turn the knob clockwise. To decrease the volume, turn the knob counterclockwise.
Option Panel
A removable plate on the rear panel covers a serial 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. To review the technical specifications for each port, refer to Chapter 9, Technical Specifications. RF Activation port Allows a connected device to receive information during RF activation of the generator, which will then generate a response in the device.
Serial port Allows connection of a computer to the generator. You can obtain information about the generator using RS-232 communications protocol. Refer to the Force EZ-C Electrosurgical Generator Service Manual.
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3 C h a p t e r Patient and Operating 3 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.
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General General
Warning 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. 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. Valleylab recommends against performing laparoscopic surgery on pregnant patients. Caution Read all warnings, cautions, and instructions provided with this generator before using. For surgical procedures where the current could flow through delicate parts of the body, the use of bipolar techniques may be desirable in order to avoid unwanted coagulation. Always use the lowest output setting 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 appendages.
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General Fire/Explosion Warning Danger: Explosion Hazard Do not use electrosurgery in the presence of flammable anesthetics. 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.1 1. 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. 96-128, September, 1996.
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General 3-4
Inadvertent Radio Frequency Burns Warning 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 50-60 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 five to eight centimeters (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. Valleylab recommends the use of REM patient return electrodes and Valleylab 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. Force EZ-C User’s Guide
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. Connect accessories 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, and 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. Do not reuse or resterilize accessories labeled “disposable” or “single use only.”
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Before Surgery
Patient Return Electrodes Valleylab recommends the use of REM 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 Valleylab REM Contact Quality Monitoring System. Valleylab 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 Valleylab E0507-B adapter. To avoid a REM alarm, you must use a REM patient return electrode with the E0507-B adapter.
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Before Surgery Generator Warning 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. Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment (except a Force Argon II 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.
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During Surgery During Surgery
Generator Power Settings Warning 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 structures are involved. Caution The Force EZ-C Generator cuts and coagulates (low 2 and low 3 settings only) effectively at power settings lower than previous models offered by Valleylab. Fulguration is similar to previous models in effectiveness at a given power setting. 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. Forceps Notice Do not activate the generator until the forceps have made contact with the patient. Product damage may occur.
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During Surgery Suction Coagulators Warning 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 will greatly increase current flow and can result in unintended surgical effect. 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).
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During Surgery
Active Accessories Warning 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.
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During Surgery 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. Laparoscopic Procedures Warning 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.
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After Surgery After Surgery
Warning Electric Shock Hazard Always turn off and unplug the generator before cleaning. Caution Do not reuse or resterilize accessories labeled “disposable” or “single use only.” Notice Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.
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Before Surgery 4
4 C h a p t e r
This chapter contains the following procedures: • Preparing the generator for surgery • Preparing for bipolar surgery • Preparing for monopolar surgery • Setting up the special features Caution Read all warnings, cautions, and instructions provided with this generator before use. Read the instructions, warnings, and cautions provided with electrosurgical accessories before use. Specific instructions are not included in this manual.
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Quick Setup Instructions Quick Setup Instructions If you are familiar with the Force EZ-C generator, you may prefer to follow this abbreviated procedure. However, if you are not familiar with how the generator should be set up, refer to Setting Up the Generator for detailed instructions. 1. Plug the generator power cord into the rear panel receptacle. 2. Plug the generator power cord into a grounded wall receptacle. 3. Turn on the generator and verify that the self-test is successfully completed. 4. Prepare for bipolar or monopolar electrosurgery: Bipolar surgery: • If using a footswitch, connect it to the appropriate footswitch receptacle on the front or rear panel. • Connect the instrument to the appropriate instrument receptacle on the front panel. • Verify or change and power settings. (Optional – to display and use the previous setting, press the Pure and BLEND buttons simultaneously.) Monopolar surgery: • If using a footswitch, connect it to the appropriate footswitch receptacle on the front or rear panel. Use only a Valleylab monopolar footswith with the Force EZ-C generator. • Connect the instrument to the appropriate instrument receptacle on the front panel. • Apply the patient return electrode to the patient and connect it to the Patient Return Electrode receptacle on the front panel. • Press and hold the LOW button to verify the selected low coag setting. The selected setting flashes in the Coag display. (To change the low coag setting, refer to Setting Up the Special Features in this chapter.) • Press and hold the HIGH button to verify the selected high coag setting. The selected setting flashes in the Coag display. (To change the high coag setting, refer to Setting Up the Special Features in this chapter.) • Verify or change the mode and power settings. (Optional – to display and use the previous setting, press the Pure and BLEND buttons simultaneously.)
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Setting Up the Generator Setting Up the Generator Warning 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. Patient Safety Use the generator only if the self-test has been completed as described. Otherwise, inaccurate power outputs may result. Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment (except a Force Argon II unit). These configurations are unstable and/or do not allow for adequate cooling. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as monitors). An activated electrosurgical generator may cause interference with them. Nonfunction of the generator may cause interruption of surgery. A backup generator should be available for use. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active. 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. 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 outlet having the correct voltage. Otherwise product damage may result. 1. Verify the generator is off by pressing the power switch off (O). 2. Place the generator on a stable flat surface, such as a table, platform, or Valleylab cart. Carts with conductive wheels are recommended. For details, refer to the procedures for your institution or to local codes. Provide at least 10 to 15 cm (4 to 6 in.) of space from the sides and top of the generator for cooling. Normally, the top, sides, and rear panel are warm when the generator is used continuously for extended periods of time. 3. Plug the generator power cord into the rear panel receptacle. 4. Plug the generator power cord into a grounded receptacle.
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Setting Up the Generator
Important Status for the most recently used mode and power settings feature momentarily appears in the Cut display. The selected low (desiccate) setting and high (fulgurate) setting momentarily appear in the Coag display.
5. Turn on the generator by pressing the power switch on ( | ). Verify the following: • All visual indicators and displays on the front panel illuminate. • Activation tones sound to verify that the speaker is working properly. 6. If the self-test is successful, a tone sounds. Verify the following: • Either the Pure button indicator or the BLEND button indicator illuminates green, and either the LOW button indicator or the HIGH button indicator illuminates green. • The right arrow indicator at the Footswitch Selector button illuminates green. • Each display shows a power setting of 1 watt. • The REM Alarm indicator illuminates red. If the self-test is not successful, an alarm tone sounds. A number may momentarily appear in the Cut display and, in most cases, the generator is disabled. Note the number and refer to Chapter 7, Responding to System Alarms. Once the self-test is successful, connect the accessories and set the generator controls. Refer to Preparing for Bipolar Surgery or Preparing for Monopolar Surgery later in this chapter.
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Preparing for Bipolar Surgery Preparing for Bipolar Surgery If you plan to use a footswitching bipolar instrument, you must connect a footswitch. You may also use a footswitch to activate a handswitching instrument. Connections for Bipolar Surgery Warning Electric Shock Hazard • Do not connect wet accessories to the generator. • Ensure that all accessories and adapters are correctly connected and that no metal is exposed. 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. Caution Read the instructions, warnings, and cautions provided with electrosurgical accessories before using. Specific instructions are not included in this manual. Inspect accessories and cords (especially reusable accessories and cords) for breaks, cracks, nicks, and other damage before every use. If damaged, do not use. Failure to observe this precaution may result in injury or electric shock to the patient or surgical team. Connect accessories to the proper receptacle type. In particular, you must connect bipolar accessories to the Bipolar Instrument receptacle only. Improper connection of accessories may result in inadvertent generator activation or a REM Contact Quality Monitor alarm. Figure 4-1. Bipolar connections (footswitch activation from the Bipolar Footswitch receptacle on the rear panel)
Footswitching or handswitching instrument
Bipolar footswitch
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Preparing for Bipolar Surgery Figure 4-2. Bipolar connections (footswitch activation from the Footswitch receptacle on the front panel) Handswitching or footswitching instrument
Figure 4-3. Bipolar connection (handswitching instrument)
Valleylab monopolar
Press the Footswitch Selector button until the left arrow indicator illuminates green.
Handswitching instrument Setting the Bipolar Output Caution Set power levels to the lowest setting before testing an accessory. 1. To increase (+) the power, turn the Bipolar Power Control knob clockwise. To decrease (-) the power, turn the knob counterclockwise. The maximum power setting for bipolar output is 70 watts. 2. To display and use the previous power setting, press the Pure and BLEND buttons simultaneously.
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Preparing for Monopolar Surgery Preparing for Monopolar Surgery If you plan to use a footswitching monopolar instrument, you must connect a Valleylab monopolar footswitch. You may also use a footswitch to activate a handswitching instrument. For most procedures, you will connect only one monopolar instrument (handswitching or footswitching). Connections for Monopolar Surgery Warning Electric Shock Hazard • Do not connect wet accessories to the generator. • Ensure that all accessories and adapters are correctly connected and that no metal is exposed. Use only a Valleylab monopolar footswitch with the Force EZ-C generator. Use of an incompatible footswitch may cause unexpected output. 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. The instrument receptacles on this generator are designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing so will cause simultaneous activation of the instruments. Caution Read the instructions, warnings, and cautions provided with electrosurgical accessories before use. Specific instructions are not included in this manual. Inspect accessories and cords (especially reusable accessories and cords) for breaks, cracks, nicks, and 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.
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Preparing for Monopolar Surgery Figure 4-4. Monopolar connections (handswitching instrument)
Handswitching instrument Figure 4-5. Monopolar connections (footswitch activation from the Monopolar Footswitch receptacle on the rear panel)
Patient return electrode
Handswitching or footswitching instrument
Patient return electrode
Valleylab monopolar footswitch
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Figure 4-6. Monopolar connections (footswitch activation from the Footswitch receptacle on the front panel)
Preparing for Monopolar Surgery
Monopolar instrument
Footswitching instrument
Patient return electrode
Press the Footswitch Selector button until the right arrow indicator illuminates green.
Applying a Patient Return Electrode to the Patient 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. Using a patient return electrode without the REM safety feature will not activate the Valleylab REM Contact Quality Monitoring System. Valleylab recommends using REM patient return electrodes to maximize patient safety. Using a patient return electrode without the REM safety feature may result in a patient burn. Refer to the manufacturer’s instructions for application site and placement procedures. When using metal plate patient return electrodes, use a conductive gel specifically designed for electrosurgery.
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Preparing for Monopolar Surgery Using Two Generators Simultaneously Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment (except a Force Argon II unit). These configurations are unstable and/or do not allow for adequate cooling. Two generators (and two patient return electrodes) may be used simultaneously on the same patient, provided the generators are the same type (both are isolated or both are ground referenced). However, the two generators are not synchronized. One return electrode frequently acquires a high positive voltage while the other acquires an opposite negative voltage. When this occurs, the potential voltage difference between them may cause the current to flow from one patient return electrode to the other. The current causes no harm if it produces no sparks or high current densities on the patient. Place each patient return electrode as close as possible to the site of the surgery to be performed by the generator to which it is connected. Ensure that the two patient return electrodes do not touch. Pacemakers Warning 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. To avoid interference with pacemakers, place the patient return electrode as close as possible to the site of surgery. Make sure the path the current follows from the site of surgery to the return electrode does not pass through the vicinity of the heart or the site where the pacemaker is implanted.
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