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.x
Part Number: PT00140952
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 software-update
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.x
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
ii Valleylab™ FX8 FX Series Energy Platform User’s Guide
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
Covidien expressly is not selling, assigning or otherwise transferring to Customer, and Customer
iv Valleylab™ FX8 FX Series Energy Platform User’s Guide
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 non-technical 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). 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.
Valleylab™ FX8 FX Series Energy Platform User’s Guide v
Software License
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.
vi Valleylab™ FX8 FX Series 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 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 . . . . . . . . . . . . . . . . . 2-8
Warnings and Precautions for Patient Return Electrodes. . . . . . . . . 2-9
Inadvertent Radio Frequency (RF) Burns . . . . . . . . . . . . . . . . . . . . . . .2-10
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 1
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
2 Valleylab FX8 FX Series Energy Platform User’s Guide
Setting the Auto Bipolar Activation Delay . . . . . . . . . . . . . . . . . . . . . . . 5-8
Closing the Auto 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 3
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
4 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 generator 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 features that 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, accessories 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.
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).
1-10 Valleylab™ FX8 FX Series Energy Platform User’s Guide
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. Two external system receptacles on the back of the generator,
labeled Interlink 1 and Interlink 2, can signal RF activation whenever RF energy from any RF
receptacle is initiated. 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 Opens the Volume window to allow changing sound levels.
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 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 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.
Up/Down arrows Up and down arrows indicate additional
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.
Software Buttons Options and confirmations are 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
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
environments.
O and oxygen) or in close proximity to volatile solvents (such as
2
) enriched
2
Use of electrosurgery in O
the O
concentration at the surgical site.
2
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.
rich environments increases the risk of fire. Therefore, take measures to reduce
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% O
If necessary, scavenge excess O
Do not attempt to recharge the generator’s lithium battery. This can cause the battery to explode.
during oropharyngeal or head and neck surgery.
2
with separate suction.
2
2-2 Valleylab™ FX8 FX Series Energy Platform User’s Guide
Loading...