Medtronic VLFX8GEN Instructions for Use

User’s Guide
TM
Valleylab
FX Series Energy Platform
FX8
User’s Guide
ValleylabTM FX8
FX Series Energy Platform
For use with software version 1.1x
Part Number: PT00129336

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™ FX8 FX Series energy platform 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™ FX8 FX Series Energy Platform Service Manual.

Equipment Covered in this Manual

Valleylab™ FX8 FX Series energy platform (VLFX8GEN) with software version 1.1x
The latest versions of the user’s guide and service manual are available at: www.medtronic.com/covidien/support/biomed-connect/electrosurgery
Call these numbers to request a hard copy of the service manual:
USA and Canada: 1 800 255 8522 Option 2
International: 1 303 476 7996
A complete list of service centers world wide is available at: www.medtronic.com/covidien/support/service-centers
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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™ FX8 FX Series Energy Platform One year from date of shipping
Limited Warranty
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™ FX8 FX Series Energy Platform User’s Guide iii

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
iv Valleylab™ FX8 FX Series Energy Platform User’s Guide
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.
Software License
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 Product in which the defective Software is installed (if embedded within a Product).
Valleylab™ FX8 FX Series Energy Platform User’s Guide v
Software License
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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Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Equipment Covered in this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Software License. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Chapter 1. Overview and General Features
The Energy Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Modes and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
System Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
The Touchscreen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
System Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Interface Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
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 Cautions for Laparoscopic Procedures. . . . . . . . . . . . . . . . . 2-12
Warnings and Precautions for Bipolar Procedures . . . . . . . . . . . . . . . . . . . .2-13
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Shunt Cords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Conductive Fluid In the Surgical Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Chapter 3. System Setup
Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Before Starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Valleylab™ FX8 FX Series Energy Platform User’s Guide vii
Turning On the Energy Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Turning Off the Energy Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Energy Platform Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Restore Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Audio Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Service and Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Monopolar Foot Pedal Activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Return Electrodes – REM Contact Quality Monitoring System . . . . . . . . . . 4-7
Patient Return Electrode Considerations . . . . . . . . . . . . . . . . . . . . . . . . 4-7
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
After Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Disconnect the Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Bipolar Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
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
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Setting the Auto Bipolar Activation Delay . . . . . . . . . . . . . . . . . . . . . . . 5-8
Closing the Bipolar Settings Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
After Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Disconnect the Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Chapter 6. Troubleshooting
General Troubleshooting Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
REM Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Correcting a REM Alarm Condition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Correcting Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
System Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Chapter 7. Maintenance and Repair
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Routine Maintenance and Periodic Safety Checks . . . . . . . . . . . . . . . . . . . . . 7-2
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Returning the Energy Platform for Service. . . . . . . . . . . . . . . . . . . . . . . 7-3
Software Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Updating Energy Platform Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Service Manual Copies and Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Covidien Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Training and Education . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Chapter 8. Technical Specifications
Energy Platform Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Environmental Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Input Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Power Cord Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Backup Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Equipotential Ground Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
EKG Blanking and Smoke Evacuation . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Internal Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Ethernet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Universal Serial Bus (USB). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Symbols Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Standards and IEC Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Class I Equipment (IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Valleylab™ FX8 FX Series Energy Platform User’s Guide ix
Type CF Equipment/Defibrillator Proof
(IEC 60601-1, IEC 60601-2-2, and ANSI/AAMI HF18) . . . . . . . . . . . . . . 8-8
IP21 Liquid Ingress/Spillage
(IEC 60601-1 and IEC 60601-2-2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Voltage Transients – Energy Platform Mains Transfer
(IEC 60601-1, IEC 60601-2-2, and ANSI/AAMI HF18) . . . . . . . . . . . . . . 8-8
CISPR 11 Class A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Electromagnetic Compatibility
(IEC 60601-1-2 and IEC 60601-2-2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Return Electrode Monitor (REM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Auto Bipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Audio Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10
Energy Output Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Output Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Output Power vs. Resistance Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-15
Monopolar Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-15
Bipolar Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-30
Discontinuous Power Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-40
x Valleylab™ FX8 FX Series Energy Platform User’s Guide
Chapter 1
Overview and General Features
This chapter provides an overview of the features and functions of the Valleylab™ FX8 FX 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™ FX8 FX Series Energy Platform User’s Guide 1-1

The Energy Platform

The Energy Platform

Introduction

The Valleylab™ FX8 FX Series energy platform (model number VLFX8GEN, generally referred to in this manual as “the energy platform” or “the generator” or “the system”) provides RF energy for monopolar and bipolar surgical applications. It features a touchscreen divided into three sections for viewing and 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 energy platform and 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 or active instruments, customers should seek detailed user instructions and warning information from the manufacturer.
The generator is intended for use in general surgery and such surgical specialties as urologic, vascular, thoracic, plastic, gynecologic, reconstructive, and colorectal surgery.
Indications for Use
The Valleylab™ FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Contraindications
None known.
1-2 Valleylab™ FX8 FX Series Energy Platform User’s Guide

Front Panel

The Energy Platform
Overview and General Features
On/Off button
User interface touchscreen
Restore Settings button
Audio Volume Control button
Service and Settings button
REM (Return Electrode Monitoring) indicator
REM patient return electrode receptacle
Monopolar 2 instrument receptacle
Monopolar 1 Universal Foot Pedal Port (UFP) receptacle
Bipolar instrument receptacle
Valleylab™ FX8 FX Series Energy Platform User’s Guide 1-3
The Energy Platform

Rear Panel

Monopolar 2 foot-pedal receptacle (requires included adapter to connect standard four-
pin monopolar foot pedal)
Monopolar 1 foot-pedal receptacle
Bipolar foot-pedal receptacle
Interlink cable receptacles for EKG blanking and smoke-evacuation control
USB port and Ethernet port (covered; for service only)
Equipotential ground connection
Power cord receptacle
Fuse drawer
1-4 Valleylab™ FX8 FX Series Energy Platform User’s Guide

Modes and Settings

The energy platform provides the following modes and settings for a variety of surgical procedures:
Monopolar modes Power Setting Ranges Peak Voltage
· CUT
- PURE Off, 1–300 W 1287 V
- BLEND Off, 1–200 W 2178 V
· VALLEYLAB 5–60 W 2783 V
· COAG
The Energy Platform
Overview and General Features
FX Bipolar modes
· PRECISE Off, 1–70 W 284 V
· STANDARD Off, 1–70 W 415 V
· MACRO Off, 1–70 W 530 V
FT Bipolar effects
· LOW Off, 1–15 W 133 V
· MEDIUM 16–40 W 214 V
· HIGH 45–95 W 462 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
Valleylab™ FX8 FX Series Energy Platform User’s Guide 1-5
The Energy Platform
Monopolar Modes
The system produces several modes of monopolar power output.
Precaution
To provide expected functionality from a handpiece, 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.
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 available for clinical use once they have been enabled in the Clinical Settings window. See Clinical Settings Window on page 3-6.
Compatible Monopolar Instruments & Devices
Catalog numbers for Covidien monopolar surgical instruments, return electrodes, foot pedals, and adapters that are fully compatible with the Valleylab™ FX8 FX Series Energy Platform are listed in the following sections.
Monopolar UFP Instruments (connect only to Monopolar 1 receptacle)
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.
1-6 Valleylab™ FX8 FX Series Energy Platform User’s Guide
Monopolar Instruments (connect only to Monopolar 2 receptacle)
FT3000DB Force TriVerse™ electrosurgical device
FT3000 Force TriVerse™ electrosurgical device
Monopolar Instruments (connect to either monopolar receptacle)
This generator is designed for use with Covidien monopolar instruments. However, other monopolar instruments are compatible with the energy platform if they have a connector that matches the following illustration, and are rated for peak voltages of at least 3932 V.
The Energy Platform
Overview and General Features
Return Electrodes (Monitoring)
E0560 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
Return Electrodes (Non-Monitoring, for use in DEMO mode only; not for clinical use)
E7506 Non-REM Polyhesive™ patient return electrode
Valleylab™ FX8 FX Series Energy Platform User’s Guide 1-7
The Energy Platform
REM Connector
E0507B Valleylab™ multiple return/S cord adapter
Foot Pedals
FT6003 ForceTriad™ three-pedal footswitch (Monopolar 2 only)
E6008 Valleylab™ monopolar footswitch (Monopolar 1, Monopolar 2 with adapter)
E6008B Valleylab™ monopolar footswitch (Monopolar 1, Monopolar 2 with adapter)
1017577 6-pin to 4-pin monopolar footswitch adapter (Monopolar 2 only)
Warning
Foot pedals made by manufacturers other than Covidien may activate the COAG mode when the CUT pedal is pressed, and activate the CUT mode when the COAG pedal is pressed. Do not use these foot pedals with the energy platform, as patient injury may result.
1-8 Valleylab™ FX8 FX Series Energy Platform User’s Guide
Bipolar Modes and Effects
Selection of bipolar modes, effects, and power settings is dependent on surgeon preferences, tissue characteristics, accessory selection, and the intended clinical application.
Default Modes
The energy platform’s default bipolar modes are the FX modes. These include the following:
PRECISE mode may be used when it is essential to maintain a high degree of precision and fine control over the amount of desiccation. Voltage is kept low to prevent sparking. Power remains constant over a specific range of tissue resistance, allowing a consistent tissue effect.
STANDARD mode may be used for most bipolar applications. Voltage is kept low to prevent sparking. Power remains constant over a specific range of tissue resistance, allowing a consistent tissue effect.
MACRO mode may be used for bipolar cutting or rapid coagulation. Voltage is higher and there is more power than in the other available bipolar modes.
The Energy Platform
Overview and General Features
Optional Mode and Effects
The energy platform has an optional bipolar mode called the FT mode. This mode’s effects include the following:
LOW effect is for power selections of 1–15 watts. It delivers low-voltage output for precision and fine control of the amount of desiccation typically used with small-surface area instruments.
MEDIUM effect is for power selections of 16–40 watts. It is a conventional bipolar output typically used with medium-surface area electrodes.
HIGH effect is for power selections of 45–95 watts. Power remains constant over a wide range of tissue types and may be used for large electrodes.
Important
The PRECISE, STANDARD, and MACRO modes (legacy Valleylab™ Force FX™ bipolar modes) are enabled by default.
The energy platform’s optional bipolar effects (LOW, MEDIUM, and HIGH) are available for clinical use if the FX mode is disabled in the Clinical Settings window. See Clinical Settings Window on page 3-6.
Important
The PRECISE, STANDARD, and MACRO modes do not correspond to the LOW, MEDIUM, and HIGH effects, respectively. Each bipolar mode and effect has its own distinct output.
For more information, see Energy Output Characteristics on page 8-12, Output Waveforms on page 8- 13, Bipolar Graphs on page 8-30, and Discontinuous Power Curves on page 8-40.
Valleylab™ FX8 FX Series Energy Platform User’s Guide 1-9
The Energy Platform
Mode or Effect Setting
PRECISE 1–70 watts Small surface-area instruments
STANDARD 1–70 watts Medium surface-area instruments
MACRO 1–70 watts Large surface-area instruments
LOW 1–15 watts Small surface-area instruments
MEDIUM 16–40 watts Medium surface-area instruments
Power Setting Range Optimized Instrumentation
Micro-tip forceps (0.4–2.2 mm)
Micro-tip forceps (1.0–2.2 mm)
Small paddle lap forceps
Bipolar scissors
Large paddle lap forceps
Micro-tip forceps (0.4–2.2 mm)
Micro-tip forceps (1.0–2.2 mm)
Small paddle lap forceps
Bipolar scissors
HIGH 45–95 watts
(5 watt increments)
Large surface-area instruments
Large paddle lap forceps
Auto Bipolar
The Auto Bipolar feature allows for activation and energy delivery without using a foot pedal.
When using this feature, the energy platform 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 select a timed activation delay for auto start of RF activation.
Note: When using Auto Bipolar, the tissue in the grasp of the bipolar device must have an impedance less than 2200 Ω. 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.
Use of a foot pedal disables the Auto Bipolar feature.
Precaution
Do not use instruments with flying leads with the energy platform.
Do not use the FT0501 ForceTriad™ bipolar adapter with the Valleylab FX8 FX Series Energy Platform.
1-10 Valleylab™ FX8 FX Series Energy Platform User’s Guide
Important
The Auto Bipolar feature is not available for clinical use until enabled via the Clinical Settings window (see Clinical Settings Window on page 3-6).
Compatible Bipolar Instruments & Devices
The energy platform is designed for use with Covidien bipolar instruments. However, other bipolar instruments are compatible if their connectors match the following illustration, and are rated for peak voltages of at least 530 V.
The Energy Platform
Overview and General Features
Catalog numbers for Covidien bipolar foot pedals that are fully compatible with the
Valleylab™ FX8 FX Series energy platform are listed in the following table.
Foot Pedals
E6009 Valleylab™ bipolar standard footswitch
E6009B Valleylab™ bipolar standard footswitch
E6019 Valleylab™ bipolar dome footswitch
Valleylab™ FX8 FX Series Energy Platform User’s Guide 1-11
The Energy Platform
Connection to External Systems
The energy platform can be connected to an external system. For example, connections can be made to enable smoke evacuation or EKG blanking during monopolar activation, or provide argon-enhanced coagulation. Refer to the external system user’s guide for detailed instructions regarding how to connect it to the generator.
Two external system receptacles on the back of the generator, labeled Interlink 1 and Interlink 2, can signal RF activation in either of the following ways:
Both external receptacles signal any RF activation
Both external receptacles signal any monopolar RF activation
The behavior that signals RF activation is in accordance with smoke evacuation regulations in the country in which the platform is being used, as denoted by the country code selected during platform setup. Refer to the external system user’s guide for detailed instructions regarding how to connect it to the generator.
Compatible External Systems
SEA3730 RapidVac™ smoke evacuator interlink cable
SE3690 RapidVac™ smoke evacuator
Valleylab
Valleylab
Warning
Only medical devices compliant with IEC 60601-1 may be connected to the external system receptacles. The use of any external system connected to the energy platform should be evaluated by qualified personnel.
Force Argon II-8 argon gas delivery unit
Force Argon II-20 argon gas delivery unit II
1-12 Valleylab™ FX8 FX Series Energy Platform User’s Guide

System Conventions

The Touchscreen

The energy platform features a user-friendly touchscreen interface to control system functions. The touchscreen is divided into three sections, each of which is associated with an adjacent instrument receptacle.
Section 1—Settings entered in this section of the touchscreen control an instrument attached to the Bipolar receptacle.
Section 2—Settings entered in this section of the touchscreen control an instrument attached to the Monopolar 1 receptacle.
Section 3—Settings entered in this section of the touchscreen control an instrument attached to the Monopolar 2 receptacle.
System Conventions
Overview and General Features
Valleylab™ FX8 FX Series Energy Platform User’s Guide 1-13
System Conventions
Generator States
The appearance of touchscreen components indicates the current state of the system.
Edit
When the system is powered on, but no instrument is attached, the instrument controls in all sections of the screen are a flat gray color, indicating that the controls can be preset. The following illustration shows monopolar controls edited prior to inserting an instrument.
Inserted
The controls change from a flat gray to a brightly illuminated color when an instrument is inserted into the associated receptacle. The following illustration shows the monopolar controls when a two-button pencil is inserted.
1-14 Valleylab™ FX8 FX Series Energy Platform User’s Guide
Activation
The black background illuminates brightly when the instrument is activated, showing the energy the instrument is delivering. Mode controls are locked during activation, preventing any change in the mode. However, power settings can be changed during activation. The following illustration shows a two-button pencil delivering energy for PURE CUT.
System Conventions
Overview and General Features

System Buttons

There are four buttons on the energy platform’s front panel:
Turns system power on and off. To turn power on, hold the
On/Off
Restore Settings
Audio Volume
Service and Settings
button for at least 1 second. To turn off, hold the button for at least 1 second. To reset a non-responsive system, hold for 10 seconds.
Restores settings from the last time the system was powered down using the On/Off button.
Opens the Volume window to allow changing sound levels.
Opens the Additional Features window, which allows access to clinical features and to energy platform settings.
Valleylab™ FX8 FX Series Energy Platform User’s Guide 1-15
System Conventions

Interface Conventions

Interface Element Name Description
Pop-up window or menu
Up/Down arrows Up and down arrows indicate additional
Software Buttons Options and confirmations are
Pop-up windows and menus appear on screen when user input is needed or requested. Pop-ups close if the user touches anywhere outside of the pop-up window.
values or selections are available for the current setting.
For numeric values, press the up or down arrow to increase or decrease the displayed value. When the value is at its maximum or minimum available setting, the appropriate arrow button becomes inactive.
represented by virtual buttons on the touchscreen. Touch on-screen buttons to select preference.
Toggle Switches Touch the virtual toggle switches to enable
(ON) or disable (OFF) options or functions.
1-16 Valleylab™ FX8 FX Series Energy Platform User’s Guide
Chapter 2
Warnings and Precautions for Patient and Operating Room Safety
This chapter provides warnings, precautions, notices, and other important information applicable to the Valleylab™ FX8 FX Series energy platform.
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 millions of 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.

Conventions Used in this Guide

Warning
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
Precaution
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.
Valleylab™ FX8 FX Series Energy Platform User’s Guide 2-1

General Warnings and Precautions

General Warnings and Precautions

Fire/Explosion Hazards

Warning
Danger - Explosion Hazard Do not use electrosurgery in the presence of flammable anesthetics or
oxidizing gases (such as nitrous oxide (N as ether or alcohol).
Fire Hazard
Do not place active instruments near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical instruments that are activated or hot from use can cause a fire. When not in use, place electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials.
Sparking and heating associated with electrosurgery can be an ignition source. Keep gauze and sponges wet. Keep electrosurgical electrodes away from flammable materials and oxygen (O enriched environments.
O and oxygen) or in close proximity to volatile solvents (such
2
)
2
Use of electrosurgery in O reduce the O
If possible, stop supplemental oxygen at least 1 minute before and during use of electrosurgery.
The use of non-flammable agents is recommended for cleaning and disinfecting wherever possible. If flammable agents are used, do not activate the energy platform until flammable vapors from skin­preparation solutions and tinctures have dissipated.
There is a risk of pooling of flammable solutions under the patient or in body depressions, such as the umbilicus, and in body cavities, such as the vagina. Any fluid pooled in these areas should be removed before activating the energy platform.
Avoid the accumulation of naturally occurring flammable gases that may accumulate in body cavities such as the bowel.
Prevent the accumulation of flammable or oxidizing gases or vapors under surgical drapes or near the surgical site.
Tissue buildup (eschar) on the tip of an active electrode may create embers that pose a fire hazard, especially in oxygen-enriched environments. Keep the electrode clean and free of all debris.
Facial and other body hair is flammable. Water soluble surgical lubricating jelly may be used to cover hair close to the surgical site to decrease flammability.
Verify that all anesthesia circuit connections are leak free before and during use of electrosurgery.
Fire Hazard During Oropharyngeal Surgery
Verify endotracheal tubes are leak free and that the cuff seals properly to prevent oxygen leaks.
concentration at the surgical site.
2
rich environments increases the risk of fire. Therefore, take measures to
2
If an uncuffed tube is in use, pack the throat with wet sponges around the uncuffed tube, and be sure to keep sponges wet throughout the procedure.
Question the need for 100% O2 during oropharyngeal or head and neck surgery.
If necessary, scavenge excess O
Do not attempt to recharge the generator’s lithium battery. This can cause the battery to explode.
with separate suction.
2
2-2 Valleylab™ FX8 FX Series Energy Platform User’s Guide
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