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
iiValleylab™ 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 PlatformOne 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 Guideiii
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
ivValleylab™ 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 Guidev
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.
viValleylab™ FX8 FX Series Energy Platform User’s Guide
xValleylab™ 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 Guide1-1
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.
1-2Valleylab™ 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 Guide1-3
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
1-4Valleylab™ 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 modesPower Setting RangesPeak Voltage
· CUT
- PUREOff, 1–300 W1287 V
- BLENDOff, 1–200 W2178 V
· VALLEYLAB 5–60 W2783 V
· COAG
The Energy Platform
Overview and General Features
FX Bipolar modes
· PRECISEOff, 1–70 W284 V
· STANDARDOff, 1–70 W415 V
· MACROOff, 1–70 W530 V
FT Bipolar effects
· LOWOff, 1–15 W133 V
· MEDIUM16–40 W214 V
· HIGH45–95 W462 V
- SOFTOff, 1–120 W264 V
- FULGURATEOff, 1–120 W3448 V
- SHARED FULGURATEOff, 1–120 W3448 V
- SPRAYOff, 1–120 W3932 V
-SHARED SPRAYOff, 1–120 W3932 V
Valleylab™ FX8 FX Series Energy Platform User’s Guide1-5
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.
1-6Valleylab™ 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)
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.
1-8Valleylab™ 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 Guide1-9
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.
1-10Valleylab™ 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 Guide1-11
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
1-12Valleylab™ 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 Guide1-13
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.
1-14Valleylab™ 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 Guide1-15
System Conventions
Interface Conventions
Interface ElementNameDescription
Pop-up window or
menu
Up/Down arrowsUp and down arrows indicate additional
Software ButtonsOptions 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 SwitchesTouch the virtual toggle switches to enable
(ON) or disable (OFF) options or functions.
1-16Valleylab™ 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 Guide2-1
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
2-2Valleylab™ FX8 FX Series Energy Platform User’s Guide
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