Valleylab ForceTriad User manual

User’s Guide
ForceTriad™
Energy Platform

ii ForceTriad User’s Guide
This manual 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 Valleylab ForceTriad™energy
platform only. Additional technical information is available in the ForceTriad™
Energy Platform Service Manual.
Equipment covered in this manual
ForceTriad™energy platform
Valleylab Part Number 1004175
Effective Date September 2006
Trademark acknowledgements
Valleylab™, ForceTriad™, Force FX™, Force EZ™, Force Argon™,
LigaSure™, LigaSmart™, Smart™, Cool-tip™, TissueFect™, REM™,
RFG-3C™, OptiMumm™, SurgiStat™, EDGE™, AccuVac™, PolyHesive™,
and Instant Response™are trademarks of Valleylab.
Klenzyme™ is a trademark of the STERIS Corporation. Enzol™ is a trademark
of Johnson and Johnson Medical Inc.
Patents pending.
Manufactured by
Valleylab
a division of Tyco Healthcare Group LP
Boulder, Colorado 80301-3299 USA
For information call
1-303-530-2300
European representative
Tyco Healthcare UK Ltd.
Gosport, PO13 0AS, UK
Made in USA
Printed in USA
©2006 Valleylab All rights reserved.
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.

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

iv ForceTriad User’s Guide
Warranty
Valleylab, a division of Tyco Healthcare Group LP, warrants each product
manufactured by it to be free from defects in material and workmanship under
normal use and service for the period(s) set forth below. Valleylab’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 Distributor within
the applicable time period shown below after delivery of the product to the
original purchaser, and which examination discloses, to Valleylab’s satisfaction,
that the product is defective. This warranty does not apply to any product, or part
thereof, which has been repaired or altered outside Valleylab’s factory in a way so
as, in Valleylab’s judgment, to affect its stability or reliability, or which has been
subjected to misuse, neglect, or accident.
The warranty periods for Valleylab products are as follows:
This warranty is in lieu of all other warranties, express or implied, including
without limitation, the warranties of merchantability and fitness for a particular
purpose, and of all other obligations or liabilities on the part of Valleylab.
Valleylab neither assumes nor authorizes any other person to assume for it any
other liability in connection with the sale or use of any of Valleylab’s products.
Notwithstanding any other provision herein or in any other document or
communication, Valleylab’s liability with respect to this agreement and products
sold hereunder shall be limited to the aggregate purchase price for the goods sold
by Valleylab to the customer. There are no warranties which extend beyond the
terms hereof. Valleylab disclaims any liability hereunder or elsewhere in
connection with the sale of this product, for indirect or consequential damages.
ForceTriad™Energy Platform One year from date of shipment
Electrosurgical Generators One year from date of shipment
RFG-3C™Plus Lesion Generator One year from date of shipment
LigaSure™Vessel Sealing System One year from date of shipment
LigaSure™Reusable Instruments One year from date of shipment
Mounting Fixtures (all models) One year from date of shipment
Footswitches (all models) One year from date of shipment
Force Argon™Units One year from date of shipment
OptiMumm™Smoke Evacuator Two years from date of shipment
LigaSure™Sterile Single Use Items Sterility only as stated on packaging
Sterile Single Use Items Sterility only as stated on packaging
Patient Return Electrodes Shelf life only as stated on packaging

ForceTriad User’s Guide v
This 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 warranty is the
District Court of the County of Boulder, State of Colorado, USA.
Valleylab, its dealers, and representatives reserve the right to make changes in
equipment built and/or sold by them at any time without incurring any obligation
to make the same or similar changes on equipment previously built and/or sold by
them.

vi ForceTriad User’s Guide

ForceTriad User’s Guide vii
Conventions Used in this Guide ..........................................................................................................................iii
Warranty..................................................................................................................................................................iv
Chapter 1. ForceTriad Energy Platform Overview and General Features
ForceTriad Energy Platform Front Panel..........................................................................................................1-2
Introduction............................................................................................................................................................1-2
System Conventions............................................................................................................................................1-3
Touchscreens..............................................................................................................................................1-3
Common Symbols......................................................................................................................................1-3
Power Modes........................................................................................................................................................1-5
Monopolar Modes.......................................................................................................................................1-5
Bipolar Modes.............................................................................................................................................1-5
LigaSure Mode............................................................................................................................................1-6
Chapter 2. Patient and Operating Room Safety
General..................................................................................................................................................................2-2
Setting Up the System...............................................................................................................................2-2
Fire/Explosion Hazard................................................................................................................................2-4
Energy Platform..........................................................................................................................................2-5
Active instruments......................................................................................................................................2-6
Pacemakers and ICDs...............................................................................................................................2-6
After Surgery...............................................................................................................................................2-7
Monopolar..............................................................................................................................................................2-7
Patient Return Electrodes.........................................................................................................................2-8
Inadvertent Radio Frequency (RF) Burns...............................................................................................2-8
Bipolar....................................................................................................................................................................2-9
LigaSure ................................................................................................................................................................2-9
LigaSure in Laparoscopic Procedures..................................................................................................2-10
Servicing..............................................................................................................................................................2-11
Shunt Cords........................................................................................................................................................2-11
Procedures Where Conductive Fluid is Introduced into the Surgical Site ................................................2-11
Laparoscopic Procedures.................................................................................................................................2-12
Chapter 3. System Setup
Setup......................................................................................................................................................................3-2
Before Startup.............................................................................................................................................3-2
Powering Up the ForceTriad Energy Platform.......................................................................................3-2
System Functions.................................................................................................................................................3-2
Adjusting Display Brightness....................................................................................................................3-2
Activation Log..............................................................................................................................................3-2

viii ForceTriad User’s Guide
Service Display...........................................................................................................................................3-3
Restore.........................................................................................................................................................3-3
Setup............................................................................................................................................................3-3
Demo Mode.................................................................................................................................................3-5
Chapter 4. Monopolar Function
Front Panel Monopolar Features.......................................................................................................................4-2
Rear Panel Monopolar Features.......................................................................................................................4-2
Monopolar Quick Setup Instructions.................................................................................................................4-3
Monopolar Function Overview...........................................................................................................................4-4
Monopolar Power Output Modes.............................................................................................................4-4
Monopolar Footswitch.........................................................................................................................................4-4
Return Electrodes – REM Contact Quality Monitoring System....................................................................4-5
Patient Return Electrode Considerations...............................................................................................4-5
How the REM System Works...................................................................................................................4-5
Patient Return Electrode Setup ...............................................................................................................4-6
Active Electrodes .................................................................................................................................................4-8
Standard Monopolar Mode Functionality................................................................................................4-8
Valleylab Mode Functionality....................................................................................................................4-9
Using a Valleylab Mode Instrument.......................................................................................................4-10
Manual Power Control Functionality .....................................................................................................4-11
Accessory Port Functionality..................................................................................................................4-12
Chapter 5. Bipolar Surgery
Front Panel Bipolar Features.............................................................................................................................5-2
Rear Panel Bipolar Features..............................................................................................................................5-2
Bipolar Quick Setup Instructions.......................................................................................................................5-3
Bipolar Function Overview..................................................................................................................................5-3
Bipolar Power Output Modes ...................................................................................................................5-3
Footswitch.............................................................................................................................................................5-4
Bipolar Electrode Function.................................................................................................................................5-4
Autobipolar Electrode Function..........................................................................................................................5-5
Chapter 6. LigaSure Tissue Fusion
Front Panel LigaSure Features..........................................................................................................................6-2
Rear Panel LigaSure Features..........................................................................................................................6-2
LigaSure Quick Setup Instructions....................................................................................................................6-3
LigaSure Function Overview..............................................................................................................................6-4
LigaSure 1 Receptacle..............................................................................................................................6-4
LigaSure 2 Receptacle..............................................................................................................................6-4

ForceTriad User’s Guide ix
Footswitch .............................................................................................................................................................6-5
Start System..........................................................................................................................................................6-5
LigaSure Instruments ..........................................................................................................................................6-6
Reusable Instrument Assembly................................................................................................................6-6
Connecting LigaSure Instruments to the Energy Platform...................................................................6-6
LigaSure Settings.................................................................................................................................................6-7
Changing the Energy Delivery Setting....................................................................................................6-7
Activating the LigaSure Instrument...................................................................................................................6-7
Alert Situations............................................................................................................................................6-8
After Surgery.........................................................................................................................................................6-9
Disconnect the instruments.......................................................................................................................6-9
Reprocessing Instruments ......................................................................................................................6-10
Chapter 7. Troubleshooting
General Troubleshooting Guidelines ................................................................................................................7-2
REM Alarms..........................................................................................................................................................7-2
Correcting a REM Alarm Condition..........................................................................................................7-2
Correcting Malfunctions ......................................................................................................................................7-3
System Alarms......................................................................................................................................................7-7
Chapter 8. Maintenance and Repair
Responsibility of the Manufacturer....................................................................................................................8-2
Routine Maintenance...........................................................................................................................................8-2
Cleaning.................................................................................................................................................................8-3
Product Service....................................................................................................................................................8-3
Returning the Energy Platform for Service.............................................................................................8-3
Adjustment to Factory Specification (Calibration)...........................................................................................8-4
Software Upgrades..............................................................................................................................................8-4
Service Centers....................................................................................................................................................8-4
Chapter 9. Technical Specifications
Performance Characteristics..............................................................................................................................9-2
General.........................................................................................................................................................9-2
Dimensions and Weight.............................................................................................................................9-2
Operating Parameters................................................................................................................................9-3
Transport and Storage...............................................................................................................................9-3
Internal Memory..........................................................................................................................................9-3
Activation Tone...........................................................................................................................................9-4
Alarm Tone..................................................................................................................................................9-4
REM Contact Quality Monitor...................................................................................................................9-5

xForceTriad User’s Guide
Autobipolar ..................................................................................................................................................9-5
Duty Cycle...................................................................................................................................................9-6
Low Frequency (50/60 Hz) Leakage Current.........................................................................................9-6
High Frequency (RF) Leakage Current..................................................................................................9-7
Input Power.................................................................................................................................................9-7
Power Cord Specification..........................................................................................................................9-8
Input Frequency..........................................................................................................................................9-8
Input Current...............................................................................................................................................9-8
Backup Power.............................................................................................................................................9-8
Equipotential Ground Connection............................................................................................................9-8
ECG Blanking .............................................................................................................................................9-8
Standards and IEC Classifications....................................................................................................................9-9
Symbols...............................................................................................................................................................9-10
Class I Equipment (IEC 60601-1)..........................................................................................................9-11
Type CF Equipment (IEC 60601-1)/Defibrillator Proof.......................................................................9-11
Liquid Spillage (IEC 60601-2-2 Clause 44.3)......................................................................................9-11
Voltage Transients (Emergency Energy Platform Mains Transfer)..................................................9-11
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)...............................................9-12
Output Characteristics.......................................................................................................................................9-13
Maximum Output for Bipolar, Monopolar, and LigaSure Modes.......................................................9-13
Available Power Settings in Watts.........................................................................................................9-14
Output Waveforms...................................................................................................................................9-16
Output Power vs. Resistance Graphs ............................................................................................................9-17
Monopolar Graphs ...................................................................................................................................9-17
Bipolar Graphs..........................................................................................................................................9-22

ForceTriad User’s Guide 1-1
1
ForceTriad Energy Platform Overview
and General Features
This chapter provides an overview of the features and functions of
the ForceTriad energy platform.
Caution
Read all warnings, cautions, and instructions provided with this system before
use.
Read the instructions, warnings, and cautions provided with electrosurgical
instruments before use. Specific instructions for electrosurgical instruments are
not included in this manual.
Chapter

ForceTriad Energy Platform Front Panel
1-2 ForceTriad User’s Guide
ForceTriad Energy Platform Front Panel
Introduction
The ForceTriad energy platform is designed to provide RF energy for monopolar
and bipolar surgical applications and tissue-fusion applications. It features three
touchscreen user interfaces, and has the ability to automatically detect handsets
and configure the generator accordingly. Safety and diagnostic functionality
include automatic fail-safe functions.
The Valleylab ForceTriad energy platform, patient return electrodes, and active
instruments are designed to work as a system. Valleylab offers a selection of
patient return electrodes and active instruments that are fully compatible with this
energy platform. When considering other manufacturers’ patient return electrodes
and/or active instruments, customers should seek detailed user instructions and
warning information from the manufacturer.
Power
Switch Universal Footswitching
Accessory Receptacle REM Patient Return
Electrode Receptacle
Monopolar 2 Instrument
Receptacle
LigaSure 1
Receptacle
Bipolar Instrument Receptacle LigaSure 2 Receptacle
Monopolar 1 Instrument Receptacle
Monopolar 1 and Accessory Touchscreen Monopolar 2 and Bipolar Touchscreen LigaSure and System Tray Touchscreen

System Conventions
ForceTriad Energy Platform
Overview and General
ForceTriad User’s Guide 1-3
System Conventions
Touchscreens
The ForceTriad energy platform features a user-friendly interface with three
touchscreens that allow the user to control system functions. The active
touchscreen or touchscreens will illuminate, and the unavailable touchscreens will
dim.
Common Symbols
Symbol Name Description
Page Up/Page Down Scroll through blocks of options that cannot be displayed on a single
screen.
Up/Down Pressing once increases/decreases the associated value or moves
highlighted selection up/down one line. Pressing and holding scrolls
up/down.
Next/Back Progresses/regresses to the next screen.
Back Space Regresses one character.

System Conventions
1-4 ForceTriad User’s Guide
Note: Additional information on symbols may be found in the Technical
Specifications chapter in this manual.
Bipolar Mute On/Off Turn on/off the audio tones produced by the system that indicate the
increase or decrease of current during a bipolar procedure.
Cancel Cancels current screen and returns to the previous screen.
Enter Accepts and initiates current selections.
System Tray The system tray contains controls that allow you to access and adjust
system settings including screen brightness and main menu options.
Brightness Each selection of this button adjusts the screen brightness to the next
of the two available brightness settings. When maximum brightness is
reached, next selection resets to the least bright setting.
Wrench Select access to the main menu, which provides user-selected options
for language, appearance, and operation.
Errors
Disabled This indicates that error warnings have been disabled using the
service menu. The generator will not alarm or give error conditions
when this symbol is activated.
Symbol Name Description

Power Modes
ForceTriad Energy Platform
Overview and General
ForceTriad User’s Guide 1-5
Power Modes
As a safety feature to prevent unexpected power delivery spikes, simultaneous
activation of multiple instruments is not possible on the ForceTriad energy
platform.
Monopolar Modes
The ForceTriad energy platform produces five different modes of power output.
Cut Modes
Pure cut provides a clean, precise cut in any tissue with little or no hemostasis.
Blend cut is a conventional blended waveform that provides slower cutting and
additional hemostasis.
Valleylab Mode
Valleylab mode is a unique combination of hemostasis and dissection and allows
the user to slow down for more hemostasis and speed up for faster dissection.
Thermal spread is equal or superior to Cut or Blend modes.
Coag Modes
Fulgurate coagulates tissue by sparking from the active electrode, through air, to
the patient tissue. Since sparks may spray unpredictably from the electrode during
fulguration, using fulguration for delicate tissue or in confined areas can
complicate surgery. Accidental sparking to adjacent areas can occur as tissue at
the surgical site dries and becomes more resistant to current flow.
Spray delivers wider fulguration; penetration is shallower and the affected tissue
area is larger than with the Fulgurate mode.
Bipolar Modes
Three bipolar modes are available: Low, Standard, and Macrobipolar.
Low delivers precision and fine control over the amount of desiccation.
Standard is a conventional bipolar output at low voltage.
Macro (Macrobipolar) may be used for bipolar cutting or rapid coagulation.
Power remains constant over a wide range of tissue types.
Autobipolar
The autobipolar feature senses tissue impedance between the two bipolar
electrodes, then uses the impedance information to automatically start or stop
bipolar RF energy delivery. Optionally, the user may choose between footswitch
start and auto start, or program a delay between auto start and RF activation.

Power Modes
1-6 ForceTriad User’s Guide
LigaSure Mode
The LigaSure tissue fusion mode can be used on arteries, veins, and lymphatics
up to and including 7 mm in diameter and tissue bundles. This system provides
precise energy delivery and electrode pressure to vessels for a controlled time
period to achieve a complete and permanent fusion of the vessel lumen. The
system has been designed to produce minimal sticking, charring, or thermal
spread to adjacent tissue.
LigaSure Instruments
The LigaSure instruments that complete the ForceTriad tissue fusion system
include multiple reusable and single use instruments for open and laparoscopic
procedures. Each reusable instrument requires a corresponding single use
electrode. The LigaSure function is only available when using Valleylab LigaSure
instruments.

ForceTriad User’s Guide 2-1
2
Patient and Operating Room Safety
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.
Chapter

General
2-2 ForceTriad User’s Guide
General
Setting Up the System
Warning
Electric Shock Hazard Connect the system power cord to a properly grounded
power receptacle. Do not use power plug adapters.
Fire Hazard Do not use extension cords.
Patient Safety Use the energy platform only if the power-up self-test has been
completed as described in this manual, otherwise inaccurate power outputs may
result.
Caution
When using a smoke evacuator in conjunction with the ForceTriad energy
platform, set the system volume control at a level that ensures that the activation
tones can be heard.
Connect only Valleylab-approved footswitches. Using footswitches from other
manufacturers may cause equipment malfunction.
Warning
Hazardous Electrical Output This equipment is for use only by trained,
licensed physicians.
Do not use electrosurgical equipment unless properly trained to use it in the
specific procedure being undertaken. Use of this equipment without such training
can result in serious, unintended patient injury, including bowel perforation and
unintended, irreversible tissue necrosis.
Always use the lowest power setting that achieves the desired surgical effect.
The active electrode should be utilized only for the minimum time necessary in
order to lessen the possibility of unintended burn injury. Accidental and
unintended burn injury has occurred during procedures in small surgical fields
and on small appendages. Pediatric applications and/or procedures performed
on small anatomic structures may require reduced power settings. The higher the
current flow and the longer the current is applied, the greater the possibility of
unintended thermal damage to tissue, especially during use on small structures.
Do not wrap the instrument cords or patient return electrode cords around metal
objects. This may induce currents that could lead to shocks, fires, or injury to the
patient or surgical team.
Electric Shock Hazard Do not connect wet instruments to the energy platform.
Ensure that all instruments and adapters are correctly connected and that no
metal is exposed at any connection points.
Confirm proper power settings before proceeding with surgery. If the proper
power settings are not known, set the power to a low setting and cautiously
increase the power until the desired effect is achieved. If increased power
settings are requested, check the patient return electrode and all instrument
connections before major power setting adjustments.

General
Patient and Operating Room
Safety
ForceTriad User’s Guide 2-3
a. U.S. Department of Health and Human Services. National Institute for
Occupational Safety and Health (NIOSH). Control of Smoke from La-
ser/Electric Surgical Procedures. HAZARD CONTROLS, Publication
No. 96-128, September, 1996.
Contact between the active electrode and any metal will greatly increase current
flow and can result in unintended surgical effect.
While using electrosurgery, the patient should not be allowed to come into direct
contact with grounded metal objects (e.g., surgical table frame, instrument table,
etc.). If this is not possible during certain procedures (e.g., those in which
noninsulated head frames are used), use extreme caution to maximize patient
safety:
• Use the lowest power setting that achieves the desired effect.
• Place the patient return electrode as close to the surgical site as possible.
• Place dry gauze between the patient and the grounded object if possible.
• Continually monitor the contact point(s).
• Do not use metal needle monitoring electrodes.
Caution
Read all warnings, cautions, and instructions provided with this energy platform
before using.
Read the instructions, warnings, and cautions provided with electrosurgical
instruments before using. Specific instructions for electrosurgical instruments are
not included in this manual.
For surgical procedures where the current could flow through delicate parts of the
body, the use of bipolar techniques may be desirable in order to avoid unwanted
coagulation.
Examine all instruments and connections to the system before using. Ensure that
the instruments function as intended. Improper connection may result in arcs,
sparks, instrument malfunction, or unintended surgical effects.
Do not turn the activation tone down to an inaudible level. The activation tone
alerts the surgical team when the energy platform is delivering RF energy.
A non-functioning ForceTriad energy platform may cause interruption of surgery.
A backup system should be available for use.
Studies have shown that smoke generated during electrosurgical procedures can
be potentially harmful to patients and the surgical team. These studies
recommend adequately ventilating the smoke by using a surgical smoke
evacuator or other means. a
Inadvertent activation may occur while installing, removing, or bending
electrodes. Ensure that the instrument cord is not connected to the ForceTriad
energy platform or that the system is OFF.
Warning

General
2-4 ForceTriad User’s Guide
Fire/Explosion Hazard
Notice
Connect the power cord to a properly grounded power receptacle having the
correct voltage. Otherwise, product damage may result.
Important
If required by local codes, connect the energy platform to the hospital
equalization connector with an equipotential cable.
Warning
Danger: Explosion Hazard Do not use electrosurgery in the presence of
flammable anesthetics.
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.