ForceTriad Users Guide v3.5x June 2013

Preface

Preface This guide and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for using the Covidien ForceTriad energy platform only. Additional technical information is available in the ForceTriad Energy Platform Service Manual. Equipment covered in this manual ForceTriad Energy Platform with software version 3.5x

Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Caution Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. Notice Indicates a hazard which may result in product damage. Important Indicates an operating tip or maintenance suggestion.

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Limited Warranty

Limited Warranty Covidien warrants each covered product listed below to be free from defects in material and workmanship for normal use and service for the period(s) set forth below. Covidien’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it (or its authorized distributor) within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Covidien’s satisfaction, that the product is defective. This limited warranty does not apply to any product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident. The warranty periods for Covidien products are as follows: ForceTriadTM Energy Platform

One year from date of shipment

Electrosurgical Generators

One year from date of shipment

Cool-tip™ RFA Generator

One year from date of shipment

Evident™ MWA Generator

One year from date of shipment

LigaSure™ Vessel Sealing System

One year from date of shipment

LigaSure™ Reusable Instruments

One year from date of shipment

Mounting Fixtures (all models)

One year from date of shipment

Footswitches (all models)

One year from date of shipment

Valleylab™ Argon Gas Delivery Unit II

One year from date of shipment

RapidVac™ Smoke Evacuator

One year from date of shipment

LigaSure™ Sterile Single Use Items

Sterility only as stated on packaging

Cool-tip™ Sterile Single Use Items

Sterility only as stated on packaging

Sterile Single Use Items

Sterility only as stated on packaging

Patient Return Electrodes

Shelf life only as stated on packaging

All purchased or supplemental software programs or updates

180 days from delivery

Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the products sold hereunder shall be limited to the aggregate purchase price for the products sold to the customer. This limited warranty is non-transferable and runs only to the original purchaser of the covered

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Limited Warranty

product(s). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of products and for any form of indirect, tort, or consequential damages. This limited warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes arising under or relating in any way to this limited warranty is the District Court of the County of Boulder, State of Colorado, USA. Covidien reserves the right to make changes in covered products built or sold by it at any time without incurring any obligation to make the same or similar changes to equipment previously built or sold by it. THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS EXPRESSLY PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

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Software License

Software License COVIDIEN AG, Tyco Healthcare Group LP, and its affiliate EbD (collectively called “COVIDIEN” herein) own the entire right, title, and interest in and to all of the computer programs and all portions thereof, and associated documentation (collectively, the “Software”) provided to Customer as may be installed in the Products and equipment addressed herein or provided separately, and it has the sole right to grant licenses hereunder. The evaluation allowance herein and any ultimate price paid by Customer for the products incorporating the Software include as a portion of that evaluation allowance, or price, a license fee granting Customer only the rights set forth in this Software License. Customer further acknowledges and agrees that the Software is owned exclusively by COVIDIEN. The Software is licensed to be used on only one computing device or Product, and a valid license must be purchased for each computing device on which the Software is installed. Single User License Grant: COVIDIEN grants to Customer a limited, nonexclusive, nonsublicensable, nontransferable and revocable license to use the Software, exclusively at Customer’s location as identified by Customer as the ship-to location of the Product, solely in machine-readable object code form only on a single central processing unit owned or leased by Customer or otherwise embedded in equipment provided by COVIDIEN, and for the sole purpose of Customer’s internal business purpose in the operation of the Product or equipment purchased from, other otherwise provided by, COVIDIEN or its affiliates. Except to the extent expressly authorized in this Software License or by law, Customer shall not and shall not cause any third party to: (i) decompile, disassemble, or reverse engineer the Software; (ii) modify or create any derivative works (including, without limitation, translations, transformations, adaptations or other recast or altered versions) based on the Software, or alter the Software in any way; (iii) merge the Software with any other software or product not supplied by Supplier; (iv) use, copy, sell, sublicense, lease, rent, loan, assign, convey or otherwise transfer the Software except as expressly authorized by the Agreement; (v) distribute, disclose or allow use of the Software, in any format, through any timesharing service, service bureau, network or by any other means, to or by any third parties; (vi) remove or modify any copyright, confidential and/or proprietary markings, legends or restriction which are in the Software originally supplied to Customer; or (vii) violate any obligations with regard to COVIDIEN’s Confidential Information. To the extent that Customer is expressly permitted by applicable mandatory law to undertake any of the activities listed in the preceding sentence, Customer will not exercise those rights until Customer has given COVIDIEN thirty (30) days written notice of Customer’s intent to exercise any such rights unless an order of a government agency of competent jurisdiction will not so allow. Except for the limited license rights expressly granted in this Software License, COVIDIEN reserves all rights in and to the Software and any modifications thereto and derivations thereof, including, but not limited to, all title, ownership, intellectual property rights and all other rights and interests. Customer will own only the hardware or physical media on which the Software is stored or processed, if any.

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Software License

Customer agrees that the Software, including the specific design and structure of individual programs, constitute confidential information and trade secrets of COVIDIEN, whether or not the programs may be copyrighted or copyrightable, and/or patented or patentable. Customer agrees not to disclose, provide, or otherwise make available such confidential information, trade secrets or copyrighted material in any form to any third party. Customer agrees that it will make the Software available only to employees, contractors, or consultants with a need to know, who are obligated to comply with all license restrictions contained in this Software License Agreement and to maintain the secrecy of the Software and all other Confidential Information. Customer is responsible for the compliance of all users with these obligations. Customer may, from time to time, request that COVIDIEN incorporate certain features, enhancements or modifications into the Software. COVIDIEN may, in its sole discretion, undertake to incorporate such changes and distribute the Software so modified to all or any of COVIDIEN's customers. All such error corrections, bug fixes, patches, updates or other modifications provided to COVIDIEN shall be the sole property of COVIDIEN. This Software License is effective until terminated. Customer may terminate this License at any time by destroying all copies of Software including any documentation. This License will terminate immediately upon notice from COVIDIEN if Customer fails to comply with any provision of this License or any supplier agreement. COVIDIEN may terminate the Software licenses granted herein and exercise all available rights by giving written notice, effective immediately, if within ten (10) business days of Customer’s receipt of a reasonably detailed written request to cure, Customer has not cured all breaches of this License’s limitations or restrictions. Upon such termination, Customer will immediately pay all undisputed fees outstanding, cease use of all Software, return or delete, at COVIDIEN’s request, all copies of the Software in Customer’s possession, and certify compliance with all of the obligations herein to COVIDIEN in writing. Limited Warranty: COVIDIEN represents and warrants to Customer that the Software will perform substantially as described in COVIDIEN's then current documentation for such Software for the longer of (a) the remaining warranty applicable to the product with which such Software was delivered (not to exceed one year) or (b) ninety (90) days from the date such Software was shipped or first made available to Customer for electronic download from COVIDIEN’s service site. If you notify COVIDIEN of defects during the warranty period, COVIDIEN will replace the Software or, at its option, refund the purchase price. Your remedy for breach of this limited warranty shall be limited to replacement or refund and shall not encompass any other damages. No dealer, distributor, agent or employee of COVIDIEN is authorized to make any modification or addition to the warranty and remedies stated above. Notwithstanding these warranty provisions, all of COVIDIEN's obligations with respect to such warranties shall be contingent on Customer’s use of the Software in accordance with this Agreement and in accordance with COVIDIEN's instructions as provided by COVIDIEN in the documentation, as such instructions may be amended, supplemented, or modified by COVIDIEN from time to time. COVIDIEN shall have no warranty obligations with respect to any failures of the Software which are the result of accident, abuse, misapplication, extreme power surge or extreme electromagnetic field. This warranty does not apply to any damages, malfunctions, or non-conformities caused to or by: (i) Customer’s use of Software in violation of the license granted under the Agreement or in a manner inconsistent with any provided documentation; (ii) use of non-

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Software License

COVIDIEN furnished equipment, software, or facilities with its equipment or Products; (iii) Customer’s failure to follow COVIDIEN’s installation, operation, repair or maintenance instructions; (iv) Customer’s failure to permit COVIDIEN timely access, remote or otherwise, to Products; (v) failure to implement all new Updates to Software provided under the Agreement; (vi) Products or equipment with their original manufacturer’s serial numbers altered, defaced or deleted; (vii) Products or equipment that have been altered, serviced or modified by a party other than COVIDIEN; or (viii) Software that has been subjected to abnormal physical or electrical stress, misuse, negligence or accident by Customer or a third party. DISCLAIMER: EXCEPT AS SPECIFIED IN THIS WARRANTY, ALL EXPRESS OR IMPLIED CONDITIONS, REPRESENTATIONS, AND WARRANTIES INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE, ARE HEREBY EXCLUDED TO THE EXTENT ALLOWED BY APPLICABLE LAW. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY LOST REVENUE, PROFIT, OR DATA, OR FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY ARISING OUT OF THIS SOFTWARE LICENSE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL ONE PARTY’S LIABILITY TO THE OTHER PARTY, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE PRICE PAID OR TO HAVE BEEN PAID BY CUSTOMER. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF THE ABOVE-STATED WARRANTY FAILS OF ITS ESSENTIAL PURPOSE. SOME STATES DO NOT ALLOW LIMITATION OR EXCLUSION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES. U.S. Government Rights. The Software is a “commercial item” developed exclusively at private expense, consisting of “commercial computer software” and “commercial computer software documentation” as such terms are defined or used in the applicable U.S. acquisition regulations. The Software is licensed hereunder (i) only as a commercial item and (ii) with only those rights as are granted to all other customers pursuant to the terms and conditions of this License. Customer shall not use, duplicate, or disclose the Software in any way not specifically permitted by this License. Nothing in this License requires COVIDIEN to produce or furnish technical data for or to Customer. If any provision of this Agreement shall be held by a court of competent jurisdiction to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect. This License Agreement contains the entire understanding and agreement between the parties respecting the Software. This Agreement may not be supplemented, modified, amended, released or discharged except by an instrument in writing signed by each party's duly authorized representative. All captions and headings in this Agreement are for purposes of convenience only and shall not affect the construction or interpretation of any of its provisions. Any waiver by either party of any default or breach hereunder shall not constitute a waiver of any provision of this Agreement or of any subsequent default or breach of the same or a different kind. The construction and performance of this Agreement will be governed by the laws of the State of Colorado without reference to its choice of law principles. The parties hereby submit to the jurisdiction of the courts of the State of Colorado.

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Contents Preface... ii Conventions Used in this Guide... ii Limited Warranty...iii Software License... v

Chapter 1. Overview and General Features ForceTriad Energy Platform Front Panel... 1-2 Introduction... 1-3 Indications for Use... 1-3 System Conventions... 1-4 Touchscreens... 1-4 Common Symbols... 1-4 Power Modes... 1-6 Monopolar Modes... 1-7 Bipolar Modes... 1-7 LigaSure Mode... 1-8

Chapter 2. Patient and Operating Room Safety General... 2-2 Setting Up the System... 2-2 Fire/Explosion Hazard... 2-4 Energy Platform... 2-5 Active Instruments... 2-5 Implanted Electronic Devices (IEDs)... 2-6 After Surgery... 2-6 Monopolar... 2-7 Patient Return Electrodes... 2-7 Inadvertent Radio Frequency (RF) Burns... 2-8 Laparoscopic Procedures... 2-9 Bipolar... 2-10 LigaSure... 2-10 LigaSure in Laparoscopic Procedures... 2-11 Servicing... 2-11 Shunt Cords... 2-11 Conductive Fluid In the Surgical Site... 2-12

Chapter 3. System Setup Setup... 3-2 Before Startup... 3-2

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Powering Up the ForceTriad Energy Platform... 3-2 System Functions... 3-2 Adjusting Display Brightness... 3-2 Activation Log... 3-2 Service Display... 3-3 Restore... 3-3 Setup... 3-3 Demo Mode... 3-9

Chapter 4. Monopolar Function Front Panel Monopolar Features... 4-2 Rear Panel Monopolar Features... 4-3 Monopolar Quick Setup Instructions... 4-4 Monopolar Function Overview... 4-4 Monopolar Power Output Modes... 4-4 Monopolar Footswitch... 4-5 Standard Monopolar Footswitching... 4-5 Software-Enabled Monopolar 1 Footswitching... 4-6 Return Electrodes – REM Contact Quality Monitoring System . 4-7 Patient Return Electrode Considerations... 4-7 How the REM System Works... 4-8 Patient Return Electrode Setup... 4-9 Monopolar Electrodes... 4-10 Standard Monopolar Mode Functionality... 4-11 Valleylab Mode Functionality... 4-12 Using a Valleylab Mode Instrument... 4-13 Manual Power Control Functionality... 4-14 Accessory Port Functionality... 4-15

Chapter 5. Bipolar Surgery Front Panel Bipolar Features... 5-2 Rear Panel Bipolar Features... 5-3 Bipolar Quick Setup Instructions... 5-3 Bipolar Function Overview... 5-4 Bipolar Power Output Modes... 5-4 Footswitch... 5-4 Bipolar Electrode Function... 5-5 Autobipolar Function... 5-6 Activation Impedance... 5-6

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Chapter 6. LigaSure Tissue Fusion Front Panel LigaSure Features... 6-2 Rear Panel LigaSure Features... 6-3 LigaSure Quick Setup Instructions... 6-3 LigaSure Function Overview... 6-4 LigaSure Receptacles... 6-5 Footswitch... 6-6 Start System... 6-6 LigaSure Instruments... 6-7 Reusable-Instrument Assembly... 6-7 Connecting LigaSure Instruments to the Energy Platform 6-7 LigaSure Settings... 6-9 Changing the Energy-Delivery Setting... 6-9 Activating the LigaSure Instrument... 6-9 Alert Situations... 6-10 After Surgery... 6-11 Disconnect the instruments... 6-11 Reprocessing Instruments... 6-12

Chapter 7. Troubleshooting General Troubleshooting Guidelines... 7-2 REM Alarms... 7-2 Correcting a REM-Alarm Condition... 7-2 Correcting Malfunctions... 7-3 System Alarms... 7-8

Chapter 8. Maintenance and Repair Responsibility of the Manufacturer... 8-2 Routine Maintenance... 8-2 Cleaning... 8-3 Product Service... 8-3 Returning the Energy Platform for Service... 8-3 Adjustment to Factory Specification (Calibration)... 8-4 Software Upgrades... 8-4 Covidien Technical Service... 8-4

Chapter 9. Technical Specifications Performance Characteristics... 9-2 General... 9-2 Dimensions and Weight... 9-2 Operating Parameters... 9-3

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Transport and Storage... 9-3 Internal Memory... 9-3 Activation Tone... 9-4 Alarm Tone... 9-4 REM Contact Quality Monitor... 9-5 Autobipolar... 9-6 Duty Cycle... 9-8 Low Frequency (50/60 Hz) Leakage Current... 9-8 High Frequency (RF) Leakage Current... 9-8 Input Power... 9-9 Power Cord Specification... 9-9 Input Frequency... 9-9 Input Current... 9-10 Backup Power... 9-10 Equipotential Ground Connection... 9-10 ECG Blanking... 9-10 Standards and IEC Classifications... 9-11 Symbols... 9-12 Class I Equipment (IEC 60601-1)... 9-13 Type CF Equipment (IEC 60601-1)/Defibrillator Proof . . . 9-13 Liquid Spillage (IEC 60601-2-2 Clause 44.3)... 9-13 Voltage Transients (Emergency Energy Platform Mains Transfer)... 9-13 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)... 9-14 Output Characteristics... 9-15 Maximum Output for Bipolar, Monopolar, and LigaSure Modes... 9-15 Available Power Settings in Watts... 9-16 Output Waveforms... 9-21 Output Power vs. Resistance Graphs... 9-22 Monopolar Graphs... 9-22 Bipolar Graphs... 9-29

Chapter 10. Valleylab Exchange Remote Software System Introduction... 10-2 Service PC Requirements... 10-2 Installing the Valleylab Exchange Service Agent... 10-3 Gather Information Needed for Installation... 10-3 Installing Valleylab Exchange... 10-4 Updating the ForceTriad Software... 10-16

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Docking the ForceTriad Energy Platform... 10-17 Using the Valleylab Exchange Service Agent... 10-21 Starting the Service Agent... 10-21 Actions Buttons... 10-24 Updating ForceTriad Software... 10-25 Activate/Deactivate Application... 10-28 Valleylab Exchange Troubleshooting... 10-39

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Chapter 1 Overview and General Features

This chapter provides an overview of the features and functions of the ForceTriad energy platform. Caution Read all warnings, cautions, and instructions provided with this system before use. Read the instructions, warnings, and cautions provided with electrosurgical instruments before use. Specific instructions for electrosurgical instruments are not included in this manual.

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ForceTriad Energy Platform Front Panel

ForceTriad Energy Platform Front Panel 2

1

4

5

6

7

3

8

9

10

11

① Monopolar 1 and Accessory Touchscreen ② Monopolar 2 and Bipolar Touchscreen ③ LigaSure and System-Tray Touchscreen ④ Power Switch ⑤ Monopolar 1 Instrument Receptacle ⑥ Universal Footswitching Accessory Receptacle ⑦ REM Patient Return Electrode Receptacle ⑧ Bipolar Instrument Receptacle ⑨ Monopolar 2 Instrument Receptacle ⑩ LigaSure 2 Receptacle ⑪ LigaSure 1 Receptacle

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ForceTriad Energy Platform User’s Guide

Introduction

The ForceTriad energy platform is designed to provide RF energy for monopolar and bipolar surgical applications and tissue-fusion applications. It features three touchscreen user interfaces, and has the ability to automatically detect handsets and configure the energy platform accordingly. Safety and diagnostic functionality include automatic failsafe functions. The Covidien ForceTriad energy platform, patient return electrodes, and active instruments are designed to work as a system. Covidien offers a selection of patient return electrodes and active instruments that are fully compatible with this energy platform. When considering other manufacturers’ patient return electrodes and/or active instruments, customers should seek detailed user instructions and warning information from the manufacturer.

Overview and General Features

Introduction

Indications for Use The ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing (sealing or fusing). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endoscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCl solution (saline) as the irrigation medium. The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments. The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures. For warnings and specific contraindications for instruments used with the ForceTriad energy platform, refer to each instrument’s instructions for use (IFU).

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System Conventions

System Conventions Touchscreens The ForceTriad energy platform features a user-friendly interface with three touchscreens that allow the user to control system functions. The active touchscreen or touchscreens will illuminate, and the unavailable touchscreens will dim.

Common Symbols Symbol

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Name

Description

Page Up/Page Down

Scroll through blocks of options that cannot be displayed on a single screen.

Up/Down

Pressing once increases/*decreases the associated value or moves highlighted selection up/down one line. Pressing and holding scrolls up/down.

Next/Back

Progresses/*regresses to the next screen.

Back Space

Regresses one character.

ForceTriad Energy Platform User’s Guide

System Conventions

Name

Description

Bipolar Mute On/ Off

Turn on/off the audio tones produced by the system that indicate the increase or decrease of current during a bipolar procedure.

Monopolar Footswitching On/Off

Turn on/off monopolar footswitching capability for Monopolar 1.

LigaSure HandActivation On/Off

Turn on/off hand activation on the LigaSure 1 or 2 control panel. See Hand-Activation On/Off Button on page 6-8.

Cancel

Cancels current screen and returns to the previous screen.

Enter

Accepts and initiates current selections.

ForceTriad Energy Platform User’s Guide

Overview and General Features

Symbol

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Power Modes

Symbol

Name

Description

System Tray

The system tray contains controls that allow you to access and adjust system settings including screen brightness and main menu options as well as a connection indicator.

Brightness

Adjusts screen brightness to the next of the two available brightness settings. When maximum brightness is reached, the next selection resets to the least bright setting.

Wrench

Displays the main menu, which provides userselected options for language, appearance, and operation.

Connection Indicator

Indicates active communication with another system such as Valleylab Exchange Remote Software System or a third party system.

Errors Disabled

This icon on a yellow background overlays the screen when error warnings have been disabled using the service menu. The energy platform will not sound an alarm or give error conditions when this symbol is activated. Touching the screen removes the icon for five seconds.

Note: Additional information on symbols may be found in Chapter 9, Technical Specifications in this manual.

Power Modes As a safety feature, simultaneous activation of multiple instruments is not possible on the ForceTriad energy platform.

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Power Modes

The ForceTriad energy platform produces five modes of power output.

Cut Modes Pure cut provides a clean, precise cut in any tissue with little or no hemostasis. Blend cut is a conventional blended waveform that provides slower cutting with simultaneous hemostasis.

Overview and General Features

Monopolar Modes

Valleylab Mode Valleylab mode is a unique combination of hemostasis and dissection that allows the user to slow down for more hemostasis and speed up for faster dissection. Thermal spread is equal to or less than Cut or Blend modes.

Coag Modes 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 delivers wider fulguration; penetration is shallower and the affected tissue area is larger than with the Fulgurate mode.

Bipolar Modes Three bipolar modes are available: Low, Standard, and Macrobipolar. Low delivers precision and fine control over the amount of desiccation. Standard is a conventional bipolar output at low voltage. Macro (Macrobipolar) may be used for bipolar cutting or rapid coagulation. Power remains constant over a wide range of tissue types.

Autobipolar The autobipolar feature senses tissue impedance between the two bipolar electrodes, then uses the impedance information to automatically start or stop bipolar RF energy delivery. Optionally, the user may choose between footswitch start and auto start, or program a delay between auto start and RF activation. Note: When using autobipolar mode, the tissue in the grasp of the bipolar device must have an impedance in the range of 20 W -1000 W. The activation impedance safety feature will not deliver RF power to the tissue if it is not within the specified range. This is a factory-set value that cannot be reset by the user.

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Power Modes

LigaSure Mode The LigaSure tissue-fusion mode can be used on arteries, veins, pulmonary vasculature, and lymphatics up to and including 7 mm in diameter and tissue bundles. This system provides precise energy delivery and electrode pressure to vessels for a controlled time period to achieve a complete and permanent fusion of the vessel lumen. The system has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue. Warning Do not attempt to fuse lung tissue with LigaSure mode or instruments.

LigaSure Instruments The LigaSure instruments that complete the ForceTriad tissue-fusion system include multiple reusable and single use instruments for open and laparoscopic procedures. Each reusable instrument requires a corresponding single-use electrode. The LigaSure function is only available when using Covidien LigaSure instruments.

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