FT10 Users Guide sw ver 4.0x March 2019

User’s Guide

TM

Valleylab FT10 FT Series Energy Platform

For use with software version 4.0x

Part Number: PT00093618

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 Valleylab™ FT10 FT Series energy platform (VLFT10GEN) only. Additional technical information, such as circuit diagrams, component part lists, descriptions, calibration instructions, component-replacement instructions, and softwareupdate instructions, is available in the Valleylab™ FT10 Energy Platform service manual.

Equipment covered in this manual Valleylab™ FT10 FT Series Energy Platform (VLFT10GEN) with software version 4.0x The latest versions of the FT10 user’s guide and the service manual are available at: https://quickassist.medtronic.com. Call these numbers to request a hardcopy of the service manual:

ii

•

USA and Canada: 1 800 255 8522 Option 2

•

International: 1 303 476 7996

Valleylab™ FT10 Energy Platform User's Guide

Limited Warranty

Limited Warranty Covidien warrants the 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 period for this Covidien product is as follows:

Valleylab™ FT10 FT Series Energy Platform

One year from date of shipping

Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the products sold hereunder shall be limited to the aggregate purchase price for the products sold to the customer. This limited warranty is non-transferable and runs only to the original purchaser of the covered product(s). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of products and for any form of indirect, tort, or consequential damages. 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.

Valleylab™ FT10 Energy Platform User's Guide

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Software License

Software License Customer hereby acknowledges that Covidien LP and or its affiliates (collectively called “COVIDIEN” herein) owns the entire right, title, and interest in and to the Software, as may be installed in the Products or Equipment addressed herein or provided separately (“Software”) (including all of the computer code, source and object, comprising the Software and all components and elements thereof ), and all associated manuals, drawings, technical information and Documentation (collectively, the “Documentation”), including, without limitation, all patent, copyright, trademark, trade secret and other intellectual property or proprietary rights (“Intellectual Property Rights”) in and to the Software and all components and elements thereof all of which shall remain the sole and exclusive property of Covidien. The amount paid by the Customer for the Products and/or Equipment incorporating the Software includes as a portion of that amount, a license fee granting Customer only the rights set forth in this Software License. This Software License will be superseded by any express Software agreement between Covidien and Customer The use of term “Product” herein includes Products and/or Equipment as applicable. 1. Single User License Grant: COVIDIEN grants to Customer a limited, nonexclusive, nonsublicensable, nontransferable and revocable license to use the Software, exclusively at location identified by Customer on the order form as the ship-to location of the Products, solely in machine-readable object code form, and only on a single central processing unit embedded in the Products as provided by COVIDIEN under this agreement, and solely for the Customer’s internal business purpose in the operation of the Products provided by COVIDIEN under this agreement. Notwithstanding anything to the contrary contained in this Agreement, the Software is licensed to be used on only one computing device or Product, and a valid license must be obtained under this Agreement for each computing device or Product with which the Software is used or in which the Software is embedded. 2. Restrictions on Use: Except to the extent expressly authorized in these Software License Terms or by law, Customer shall not and shall not cause any third part 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) of or based on the Software, or alter the Software in any way; (iii) merge the Software with any other software or product not supplied by Covidien; (iv) use, copy, sell, sublicense, lease, rent, loan, assign, convey or otherwise transfer the Software except as expressly authorized by this 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 third parties; (vi) remove or modify any copyright, confidential or proprietary markings, legends or restrictions that are in the Software originally supplied to Customer; or (vii) violate any obligations with regard to Covidien’s Confidential Information (as defined below). 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 unless and until Customer has given Covidien not less than 30 days’ prior 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. This License will terminate immediately upon notice from Covidien if Customer fails to comply with any provision of this License or any agreement. 3. Reservation of Rights: Notwithstanding anything to the contrary contained in this Agreement, or any order form, purchase order or agreement between the parties, all rights not expressly granted by Covidien to Customer are reserved to and retained by Covidien and

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Valleylab™ FT10 Energy Platform User's Guide

Software License

Covidien expressly is not selling, assigning or otherwise transferring to Customer, and Customer is not purchasing or otherwise acquiring or obtaining, any of Covidien’s Intellectual Property Rights or other rights in or to the Software or Documentation. 4. Confidentiality: Customer agrees that the Software and the Documentation, and all components and elements of the Software and Documentation, including, without limitation, the specific design and structure of individual programs, constitutes confidential information and trade secrets of Covidien (the “Confidential Information”). Customer agrees not to disclose, provide, or otherwise make available such Confidential Information, including, without limitation, any trade secrets or copyrighted material, in any form to any third party. Customer agrees that it will make the Software available only to those employees, contractors, or consultants of Customer with a specific need to know, who are obligated to comply with the restrictions contained in these Software License Terms and to maintain secrecy of the Software and all other Confidential Information and are properly trained in its use. Customer is responsible for the compliance of all users of the Software and Products with these obligations and shall cause all users of the Software and Products to comply with these obligations. Customer acknowledges that the Software embodies proprietary trade secrets of Covidien including, without limitation, technical and nontechnical information regarding the Software and the development and manufacture of the same. Customer hereby agrees to maintain the confidentiality of such trade secrets using at least as great a degree of care as Customer uses to maintain the confidentiality of its own most confidential information. Customer shall communicate these obligations to those employees and agents of Customer who come into contact with the Software, and shall use its best efforts to ensure their compliance with all confidentiality obligations applicable to Customer. 5. Change Orders: Covidien shall have the right, at any time during the Term, by written request to Customer (an “Update Notice”), to require that Customer return the Products and Software to Covidien for such periods of time as are required by Covidien (“Update Periods”) or to allow Covidien to access the Software at the Customer’s location for the purpose of enabling Covidien to incorporate Software revisions, updates or modifications from time to time. Upon receipt of an Update Notice, Customer shall return the requested Products and Software to Covidien at Covidien’s cost and expense, or work with Covidien to find a suitable time for Covidien to access the Software at the Customer’s location. Customer acknowledges and agrees that during Update Periods, if the Software must be returned to Covidien, the Products and Software will be unavailable to Customer and in Covidien’s possession. Covidien will use reasonable commercial efforts to perform the revisions, updates or modifications and to return the revised, updated or modified Products and Software to Customer as soon as is reasonably practicable. 6. Software License Term: The term of the Software license granted under this Software License shall be for the commercial life of the associated Product or Equipment. 7. 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 and the remaining warranty, or extended warranty, if any, applicable to the Product or Equipment with which such Software was delivered. If Customer notifies Covidien of defects during the applicable warranty period, and those defects are verified by Covidien, as Customer’s sole and exclusive remedy, Covidien will replace the defective Software or, at its option, terminate this Software License and refund to Customer the amount paid by Customer to Covidien for the Software (if provided separately from a Product) or for the

Valleylab™ FT10 Energy Platform User's Guide

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Software License

Product in which the defective Software is installed (if embedded within a Product). Customer’s remedy for breach of this limited warranty shall be limited to the foregoing 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 herein. Notwithstanding these limited 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 provided by Covidien, as such instructions may be amended, supplemented, or modified by Covidien, in its sole discretion, from time to time. Covidien shall have no warranty obligations with respect to any failures of the Software that are the result of accident, abuse, misapplication, extreme power surge or extreme electromagnetic field, or any other cause outside of Covidien’s control. This limited warranty does not apply to any damages, malfunctions, or non-conformities caused to or by; (i) Customer’s use of Software in violation of these Software License Terms or in a manner inconsistent with any Documentation or instructions provided by Covidien; (ii) use of non-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 features, revisions, modifications, updates, patches, “bug fixes”, or new versions of or to the Software provided by Covidien under this Agreement or otherwise; (vi) Products with there original manufacturer’s serial numbers altered, defaced or deleted; (vii) Products that 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. 8. Export Laws: THESE SOFTWARE TERMS ARE EXPRESSLY MADE SUBJECT TO ANY AND ALL LAWS, REGULATIONS, ORDERS, OR OTHER RESTRICTIONS WITH RESPECT TO THE EXPORT FROM THE UNITED STATES OF AMERICA OF THE SOFTWARE. BUYER SHALL NOT EXPORT OR RE-EXPORT THE SOFTWARE (I) WITHOUT FULL COMPLIANCE WITH SUCH LAWS, REGULATIONS, ORDERS AND OTHER RESTRICTIONS, INCLUDING, WITHOUT LIMITATION, OBTAINING ALL NECESSARY APPROVAL FROM ALL REQUIRED GOVERNMENTAL AGENCIES AND (II) WITHOUT THE PRIOR WRITTEN CONSENT OF COVIDIEN. 9. 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. 10. Survival. Sections 2, 3, 4, 8, 9 and this Section 10 shall survive the termination or expiration of these Software License Terms.

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Valleylab™ FT10 Energy Platform User's Guide

Table of Contents Preface... ii Equipment covered in this manual... ii Limited Warranty... iii Software License... iv

Chapter 1. Overview and General Features The Valleylab™ FT10 Energy Platform... 1-2 Introduction... 1-2 Front Panel... 1-3 Rear Panel... 1-4 Modes & Settings... 1-5 System Conventions... 1-16 Touchscreen... 1-16 System Buttons... 1-18 Interface Conventions... 1-19

Chapter 2. Warnings and Precautions for Patient and Operating Room Safety Conventions Used in this Guide... 2-1 General Warnings and Precautions... 2-2 Fire/Explosion Hazards... 2-2 System Setup Warnings and Precautions... 2-3 Warnings and Precautions for the Energy Platform... 2-6 Warnings and Precautions for Active Instruments... 2-7 Warnings for Implanted Electronic Devices (IEDs)... 2-8 Post Surgery Safety Issues... 2-9 Warnings and Precautions for Monopolar Procedures... 2-9 Warnings and Precautions for Patient Return Electrodes...2-10 Inadvertent Radio Frequency (RF) Burns... 2-11 Warnings and Precautions for Laparoscopic Procedures... 2-13 Warnings and Precautions for Bipolar Procedures... 2-14 Warnings and Precautions for LigaSure™ Technology Procedures...2-14 Warnings and Precautions for Bipolar Resection... 2-15 Warnings and Precautions for Cardioblate™ Ablation Procedures...2-15 Contraindications for the Cardioblate™ Ablation System...2-15 Cardioblate™ Ablation System Operation... 2-18 Cardioblate™ Ablation System Adverse Events... 2-19 Shunt Cords... 2-19

Valleylab™ FT10 Energy Platform User’s Guide

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Conductive Fluid In the Surgical Site... 2-19 Servicing... 2-20

Chapter 3. System Setup Setup... 3-2 Unpacking the System... 3-2 Before Starting the System... 3-2 Turning On the Valleylab™ FT10 Energy Platform... 3-3 Turning Off the Valleylab™ FT10 Energy Platform... 3-3 Saved Settings... 3-4 Selecting and Editing a Group... 3-5 Renaming a Group... 3-7 Deleting Groups... 3-7 Favorite Settings... 3-9 Favorite Options... 3-9 Adding a Favorite... 3-10 Editing a Favorite... 3-12 Renaming a Favorite... 3-13 Deleting a Favorite... 3-13 Recent Settings... 3-14 System Functions... 3-15 On/Off... 3-15 Restore Settings... 3-15 Audio Volume... 3-16 Service and Settings... 3-17 Service and Settings... 3-17 Logs... 3-18 DEMO Mode... 3-19 System Menu... 3-20 Service Menu... 3-21 Language Selection Menu... 3-21

Chapter 4. Monopolar Front Panel Monopolar Features... 4-2 Rear Panel Monopolar Features... 4-3 Monopolar Quick Setup Instructions... 4-4 Monopolar Function Overview... 4-5 Monopolar Power Output Modes... 4-5 Foot Pedal... 4-5 Monopolar Foot-Pedal Activation... 4-6 Return Electrodes – REM™ Contact Quality Monitoring System... 4-6 Patient Return Electrode Considerations... 4-7

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Valleylab™ FT10 Energy Platform User’s Guide

How the REM™ System Works... 4-7 Patient Return Electrode Setup... 4-8 Monopolar Electrodes... 4-10 Monopolar Mode Settings... 4-10 VALLEYLAB™ Mode Functionality... 4-12 Using a VALLEYLAB-Mode Instrument... 4-13 SHARED COAG Functionality... 4-14 Closing Monopolar Settings Window... 4-16 After Surgery... 4-17 Disconnect the instruments... 4-17

Chapter 5. Bipolar Front Panel Bipolar Features... 5-2 Rear Panel Bipolar Features... 5-2 Bipolar Quick Setup Instructions... 5-3 Bipolar Function Overview... 5-3 Bipolar Power Output Modes... 5-3 Bipolar Default Settings... 5-4 Foot Pedal... 5-4 Virtual Ammeter... 5-5 Setting the Ammeter... 5-5 Auto Bipolar Function... 5-6 Turning Auto Bipolar ON/OFF... 5-6 Auto Bipolar Activation Impedance... 5-7 Setting the Auto Bipolar Activation Delay... 5-7 Closing the Bipolar Settings Window... 5-8 Bipolar Adapter... 5-8 After Surgery... 5-9 Disconnect the instruments... 5-9

Chapter 6. LigaSure™ Technology Front Panel LigaSure™ Technology Features... 6-2 Rear Panel LigaSure™ Technology Features... 6-2 LigaSure™ Technology Quick Setup Instructions... 6-3 LigaSure™ Technology Function Overview... 6-4 LigaSure™ Technology Default Settings... 6-5 LigaSure™ Technology/Bipolar Receptacle... 6-5 Foot Pedal... 6-6 LigaSure™ Technology Instruments... 6-6 Reusable-Instrument Assembly... 6-6

Valleylab™ FT10 Energy Platform User’s Guide

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Connecting LigaSure™ Technology Instruments to the Energy Platform... 6-6 Activating the LigaSure™ Technology Instrument... 6-10 Alert Situations... 6-10 BiZact™ Function Overview... 6-12 After Surgery... 6-13 Disconnect the instruments... 6-13

Chapter 7. Bipolar Resection Front Panel Bipolar Resection Features... 7-2 Rear Panel Bipolar Resection Features... 7-2 Bipolar Resection Quick Setup Instructions... 7-3 Bipolar Resection Function Overview... 7-3 LigaSure™ Technology/Bipolar Receptacle... 7-4 Bipolar Resection Default Settings... 7-4 Foot Pedal... 7-5 Connecting Bipolar Resection Instruments to the VLFT10GEN . . . 7-6 Bipolar Resection Settings... 7-6 Changing the Energy-Delivery Setting... 7-6 Activating a Bipolar Resection Instrument... 7-7 Incorrect Foot-Pedal Error... 7-7 After Surgery... 7-8 Disconnect the Instruments... 7-8

Chapter 8. Cardioblate™ Surgical Ablation System Front Panel Cardioblate™ Ablation Features... 8-2 Rear Panel Cardioblate™ Ablation Features... 8-2 Cardioblate™ Ablation System Quick Setup Instructions... 8-3 Cardioblate™ Ablation System Function Overview... 8-4 Monopolar Mode... 8-4 Cardioblate™ Ablation System Default Settings... 8-5 Cardioblate™ Ablation System Receptacles... 8-5 Monopolar 2 Receptacle... 8-5 LigaSure™ Technology/Bipolar Receptacle... 8-5 Cardioblate™ Ablation System Single Foot Pedal for Monopolar and Bipolar... 8-6 Cardioblate™ Ablation System Instruments and Devices... 8-6 Connecting Monopolar Cardioblate™ Devices to the Energy Platform... 8-6 Connecting Bipolar Cardioblate™ Devices to the Energy Platform... 8-7

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Valleylab™ FT10 Energy Platform User’s Guide

Cardioblate™ Ablation System Monopolar Settings... 8-8 Changing the Cardioblate™ Ablation System Monopolar Energy-Delivery Setting... 8-8 Cardioblate™ Ablation System Bipolar Settings... 8-9 Switching between Cardioblate™ Ablation System Monopolar and Bipolar Operation... 8-9 Activating a Cardioblate™ Ablation System Monopolar Pen... 8-10 Activating a Cardioblate™ Ablation System Bipolar Device... 8-10 Transmurality Indicator for Bipolar Lesions... 8-11 Alert Situations... 8-12 High Impedance Detected... 8-12 Low Impedance Detected... 8-13 Prolonged Activation... 8-13 Return Electrode Over-Temperature... 8-14 Verification Error... 8-14 Cardioblate™ Ablation System Historical Graph Review... 8-15 Cardioblate™ Ablation System Historical Graph Data Export... 8-15 After Surgery... 8-16 Disconnect the instruments/devices... 8-16

Chapter 9. Troubleshooting General Troubleshooting Guidelines... 9-2 REM Alarms... 9-2 Correcting a REM-Alarm Condition... 9-2 Correcting Malfunctions... 9-3 System Errors... 9-8

Chapter 10. Maintenance and Repair Responsibility of the Manufacturer... 10-2 Routine Maintenance and Periodic Safety Checks... 10-2 Cleaning... 10-3 Product Service... 10-3 Returning the Energy Platform for Service... 10-4 Software Updates... 10-4 Updating Energy Platform Software... 10-5 Service Manual Copies and Updates... 10-6 Covidien Technical Service... 10-6 Training/Education... 10-6

Chapter 11. Technical Specifications Valleylab™ FT10 Energy Platform Specifications... 11-2

Valleylab™ FT10 Energy Platform User’s Guide

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General... 11-2 Dimensions and Weight... 11-2 Environmental Parameters... 11-3 Input Power... 11-3 Power Cord Specifications... 11-4 Backup Power... 11-4 Equipotential Ground Connection... 11-4 EKG Blanking and Smoke Evacuation... 11-4 Internal Memory... 11-5 Duty Cycle... 11-5 Leakage... 11-5 Radio Frequency Identification (RFID)... 11-6 FCC Statement... 11-6 Ethernet... 11-7 USB... 11-7 Monopolar 2 Communication... 11-7 Symbols Used... 11-7 Standards and IEC Classifications...11-11 Class I Equipment (IEC 60601-1)...11-11 Type CF Equipment/Defibrillator Proof (IEC 60601-1, IEC 60601-2-2, and ANSI/AAMI HF18)...11-11 IP21 Liquid Ingress/Spillage (IEC 60601-1 and IEC 60601-2-2)...11-11 Voltage Transients – Energy Platform Mains Transfer (IEC 60601-1, IEC 60601-2-2, and ANSI/AAMI HF18)...11-11 CISPR 11 Class A...11-12 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)...11-12 Return Electrode Monitor (REM)...11-12 Auto Bipolar...11-14 Audio Tones...11-15 Displayed Time Accuracy...11-17 Energy Output Characteristics...11-17 Output Waveforms...11-19 Output Power vs. Resistance Graphs...11-21 Monopolar Graphs...11-21 Bipolar Graphs...11-36 Discontinuous Power Curves...11-52

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Valleylab™ FT10 Energy Platform User’s Guide

Chapter 1 Overview and General Features

This chapter provides an overview of the features and functions of the Valleylab™ FT10 FT Series energy platform. Precaution Read the instructions, warnings, and precautions provided with this energy platform and associated accessories before using. Specific instructions for electrosurgical instruments are not included in this manual.

Valleylab™ FT10 Energy Platform User's Guide

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The Valleylab™ FT10 Energy Platform

The Valleylab™ FT10 Energy Platform Introduction The Valleylab™ FT10 FT Series Energy Platform (VLFT10GEN) provides RF energy for monopolar and bipolar surgical applications, tissue-fusion and vessel-sealing applications, and cardiac applications. It features a touchscreen divided into four quadrants for viewing settings, user input of settings, and options available for any application. The energy platform automatically detects coded handsets and configures the energy platform accordingly. Safety and diagnostic functionality include automatic fail-safe functions. The Valleylab™ FT10 Energy Platform, applied parts (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. •

Refer to each instrument’s instructions for use (IFU) for indications, warnings, and specific contraindications.

•

When considering other manufacturers’ patient return electrodes and/or active instruments, customers should seek detailed user instructions and warning information from the manufacturer.

The energy platform is intended for use in general surgery and such surgical specialties as urologic, vascular, thoracic, plastic, gynecologic, reconstructive, cardiac, and colorectal surgery.

Indications for Use The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The 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.

Contraindications The cardiac tissue ablation feature is contraindicated for patients that have active endocarditis at the time of surgery. Ablation in a pool of blood is contraindicated (for example, through a purse string suture).

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Valleylab™ FT10 Energy Platform User's Guide

The Valleylab™ FT10 Energy Platform

Overview and General Features

Front Panel

10

9 FT10

11

8 1

2

3 4

5 6

7

཰ On/Off button ཱ Restore Settings button ི Audio Volume control button ཱི Service/Settings button ུ REM™ (Return Electrode Monitoring) indicator ཱུ Interface touchscreen ྲྀ REM patient return electrode receptacle ཷ LigaSure™ technology/Bipolar receptacle ླྀ Monopolar 2 instrument receptacle ཹ Monopolar 1 Universal Foot Pedal Port (UFP) receptacle ེ Bipolar instrument receptacle

Valleylab™ FT10 Energy Platform User's Guide

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The Valleylab™ FT10 Energy Platform

Rear Panel 2

1

3

Monopolar 2

4

Monopolar 1

Bipolar

5 Warning: Risk of Fire. Replace Fuse as Marked 250V, F10.0A (100-127Vac) 250V, F6.3A (220-240Vac)

Monopolar Monopolar

2

1

Avertissement: Risque du feu. Remplacez les fusibles comme marqués. 250V, F10.0A (100-127Vac) 250V, F6.3A (220-240Vac)

10

9

8

7

6

཰ Monopolar 2 foot-pedal receptacle (requires included adapter to connect standard fourpin monopolar foot pedal)

ཱ Monopolar 1 foot-pedal receptacle ི LigaSure™ technology/Bipolar foot-pedal receptacle (requires included adapter to connect a bipolar resection foot pedal)

ཱི Bipolar foot-pedal receptacle ུ Fuse drawer ཱུ Power cord receptacle ྲྀ Equipotential ground connection ཷ Service receptacle (Covered. For service only.) ླྀ Ethernet receptacle (Covered. For service only.) ཹ Interlink cable receptacles for EKG blanking and smoke-evacuation control

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Valleylab™ FT10 Energy Platform User's Guide

The Valleylab™ FT10 Energy Platform

The Valleylab™ FT10 energy platform provides the following modes and settings for a variety of surgical procedures:

Monopolar modes

Power-Setting Ranges

Peak Voltage

- PURE

Off, 1–300 W

1287 V

- BLEND

Off, 1–200 W

2178 V

5–60 W

2783 V

- SOFT

Off, 1–120 W

264 V

- FULGURATE

Off, 1–120 W

3448 V

- SHARED FULGURATE

Off, 1–120 W

3448 V

- SPRAY

Off, 1–120 W

3932 V

-SHARED SPRAY

Off, 1–120 W

3932 V

· PRECISE

Off, 0.5–70 W

184 V

· STANDARD

Off, 1-70 W

415 V

· MACRO

Off, 1-70 W

530 V

No power settings

244 V

· CUT

1–6

849 V

· COAG

1–6

318 V

· Monopolar

Off, 1-50 W

382 V

· Bipolar

No power Settings

382 V

· CUT

· VALLEYLAB

Overview and General Features

Modes & Settings

· COAG

Bipolar modes

LigaSure™ technology (tissue fusion) Bipolar Resection effects

Cardioblate™ Ablation

Valleylab™ FT10 Energy Platform User's Guide

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The Valleylab™ FT10 Energy Platform

Electrosurgical Monopolar Modes The system produces six modes of monopolar power output for electrosurgery. Precaution To provide expected functionality from a hand piece, proper insertion is required. Refer to the alignment dots below the receptacles for proper insertion orientation.

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.

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.

COAG Modes •

SOFT desiccates tissue at a relatively slower rate with deeper thermal penetration. It is typically performed with a ball electrode and a saline drip.

•

FULGURATE coagulates tissue by sparking from the active electrode, through air, to the patient tissue.

•

SPRAY delivers wider fulguration; penetration is shallower and the affected tissue area is larger than with the FULGURATE mode.

•

SHARED allows two monopolar instruments to activate simultaneously in either FULGURATE or SPRAY modes. A single power setting is provided and power is shared between the two instruments.

Note: SOFT and SHARED COAG modes are features that are not available on the clinical screen until they have been enabled. These features can be enabled through Valleylab™ Exchange by a Covidien sales representative. Compatible Monopolar Instruments & Devices The following Covidien catalog numbers for monopolar surgical instruments, return electrodes, foot pedals, and adapters are fully compatible with the Valleylab™ FT10 energy platform. Monopolar UFP Instruments (connect only to Monopolar 1) E05021 Monopolar Adapter E050212 Monopolar Adapter

The Monopolar 1 UFP-receptacle, identified by a blue ring, accepts UFP connectors with diameters of 4 mm to 8 mm, and lengths of 15.2 mm to 41.7 mm. UFP connectors with a diameter of less than 4 mm require an adapter to connect to the Monopolar 1 UFP receptacle.

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Valleylab™ FT10 Energy Platform User's Guide

The Valleylab™ FT10 Energy Platform

FT3000DB Force TriVerse™ Electrosurgical Device FT3000 Force TriVerse™ Electrosurgical Device

Monopolar Instruments (connect to either Monopolar 1 or Monopolar 2) This energy platform is designed for use with Covidien monopolar instruments. However, other monopolar instruments are compatible with the Valleylab™ FT10 energy platform if they have a connector that matches the following figure, are rated for peak voltages of at least 3932 V, and have a total length no greater than 17 ft (5.2 m).

Overview and General Features

Monopolar Instruments (connect only to Monopolar 2 receptacle)

Monopolar

Utilizes 4 mm banana pins Return Electrodes (Monitoring) E0560 Valleylab™ REM Patient Return Electrode Cord E7507 REM Polyhesive™ Adult Patient Return Electrode E7507DB REM Polyhesive™ Adult Patient Return Electrode E7508 REM Polyhesive™ Adult Cordless Patient Return Electrode E7509 REM Polyhesive™ Adult Cordless Patient Return Electrode E7509B REM Polyhesive™ Adult Cordless Patient Return Electrode E7510-25 REM Polyhesive™ Infant Patient Return Electrode E7510-25DB REM Polyhesive™ Infant Patient Return Electrode E7512 REM Polyhesive™ Neonatal Patient Return Electrode

Valleylab™ FT10 Energy Platform User's Guide

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