Valleylab ForceTriad User manual

Service Manual

ForceTriad

Energy Platform

™

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 servicing the Valleylab ForceTriad™ energy platform only. Additional users information is available in the

ForceTriad™ Energy Platform User’s Guide.

Caution

Federal (USA) law restricts this device to sale by or on the order of a physician.

Equipment covered in this manual

ForceTriad™ energy platform The ForceTriad Ener gy Platform Service Manual consists of two parts - the text

(part 1 of 2) and a schematics supplement (part 2 of 2), which contains the schematics.

Valleylab Part Number 1006381 Effective Date May 2009

Trademark acknowledgements

Valleylab™, ForceTriad™, Force FX™, Force EZ™, Force Argon™, LigaSure™, LigaSmart™, Smart™, Cool-tip™, TissuFect™, REM™, RFG-3C™, 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

ii ForceTriad Service Manual

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.

ForceTriad Service Manual iii

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:

ForceTriad™ Energy Platform One year from date of shipment

Electrosurgical Generators One year from date of shipment

RFG-3C

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

RapidVac™ Smoke Evacuator One year from date of shipment

LigaSure

Sterile Single Use Items Sterility only as stated on packaging

Patient Return Electrodes Shelf life only as stated on packaging

™ Plus Lesion Generator One year from date of shipment

™ Units One year from date of shipment

™ Sterile Single Use Items Sterility only as stated on packaging

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.

iv ForceTriad Service Manual

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.

ForceTriad Service Manual v

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

List of Components..............................................................................................................................................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

vi ForceTriad Service Manual

Activation Log..............................................................................................................................................3-2

Service Display ...........................................................................................................................................3-3

Restore.........................................................................................................................................................3-3

Setup ............................................................................................................................................................3-3

Demo Mode.................................................................................................................................................3-5

Chapter 4. Technical Specifications

Performance Characteristics..............................................................................................................................4-2

General.........................................................................................................................................................4-2

Dimensions and Weight.............................................................................................................................4-2

Operating Parameters................................................................................................................................4-3

Transport and Storage...............................................................................................................................4-3

Internal Memory..........................................................................................................................................4-3

Activation Tone...........................................................................................................................................4-4

Alarm Tone..................................................................................................................................................4-4

REM Contact Quality Monitor...................................................................................................................4-5

Autobipolar...................................................................................................................................................4-5

Duty Cycle....................................................................................................................................................4-7

Low Frequency (50/60 Hz) Leakage Current.........................................................................................4-7

High Frequency (RF) Leakage Current................................................................................................... 4-7

Input Power..................................................................................................................................................4-8

Power Cord Specification..........................................................................................................................4-9

Input Frequency..........................................................................................................................................4-9

Input Current................................................................................................................................................4-9

Backup Power.............................................................................................................................................4-9

Equipotential Ground Connection............................................................................................................4-9

ECG Blanking..............................................................................................................................................4-9

Standards and IEC Classifications..................................................................................................................4-10

Symbols...............................................................................................................................................................4-11

Class I Equipment (IEC 60601-1)..........................................................................................................4-12

Type CF Equipment (IEC 60601-1)/Defibrillator Proof.......................................................................4-12

Liquid Spillage (IEC 60601-2-2 Clause 44.3).......................................................................................4-12

Voltage Transients (Emergency Energy Platform Mains Transfer)..................................................4-12

Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ...............................................4-13

Output Characteristics.......................................................................................................................................4-18

Maximum Output for Bipolar, Monopolar, and LigaSure Modes.......................................................4-18

Available Power Settings in Watts.........................................................................................................4-19

Output Waveforms....................................................................................................................................4-21

Output Power vs. Resistance Graphs.............................................................................................................4-22

ForceTriad Service Manual vii

Monopolar Graphs ...................................................................................................................................4-22

Bipolar Graphs..........................................................................................................................................4-27

Chapter 5. Principles of Operation

Block Diagram......................................................................................................................................................5-2

Functional Overview............................................................................................................................................5-3

TissueFect Tissue Sensing Technology................................................................................................. 5-3

REM Contact Quality Monitoring System...............................................................................................5-3

High Voltage DC (HVDC) Power Supply Principles of Operation................................................................5-4

RF Principles of Operation.................................................................................................................................5-5

REM..............................................................................................................................................................5-5

Autobipolar ..................................................................................................................................................5-5

Leakage Current Monitor..........................................................................................................................5-5

Sensor Circuit ............................................................................................................................................. 5-6

Steering Relay PCBA Principles of Operation ................................................................................................5-7

Circuit Descriptions for the Force Triad Display PCBA..................................................................................5-7

Hotlink Transceiver U1..............................................................................................................................5-7

Liquid Crystal Display (LCD) Driver Inside the FPGA U28..................................................................5-7

Touchscreen Driver....................................................................................................................................5-8

LCD Brightness DAC Control...................................................................................................................5-8

Barcode Driver............................................................................................................................................5-8

Power Supply.............................................................................................................................................. 5-8

Footswitch/Audio PCBA Circuitry Description.................................................................................................5-9

Overview......................................................................................................................................................5-9

Power Supplies...........................................................................................................................................5-9

Communications.........................................................................................................................................5-9

Audio Data...................................................................................................................................................5-9

Footswitch Data........................................................................................................................................5-10

Expansion Port DAC Data ......................................................................................................................5-10

DAC Amplifier ...........................................................................................................................................5-10

Isolated Footswitch and Expansion Port Circuitry............................................................................... 5-10

Host Processor.........................................................................................................................................5-10

Digital Signal Processor (DSP) Controlled Data Converters.............................................................5-11

Interface Control Logic PLD ...................................................................................................................5-11

Data Converters .......................................................................................................................................5-11

External Peripherals................................................................................................................................. 5-11

viii ForceTriad Service Manual

Chapter 6. Setup, Tests, and Adjustments

Setting Up the Generator....................................................................................................................................6-2

Periodic Safety Check.........................................................................................................................................6-3

Recommended Test Equipment...............................................................................................................6-4

Inspecting the Generator and Accessories ............................................................................................6-4

Inspecting the Internal Components........................................................................................................6-6

Testing the Generator................................................................................................................................6-7

Verifying REM Function.............................................................................................................................6-7

Confirming Outputs ....................................................................................................................................6-8

Checking Low Frequency Leakage Current.........................................................................................6-13

Checking High Frequency Leakage Current........................................................................................6-15

Calibrating the ForceTriad Energy Platform..................................................................................................6-16

Chapter 7. Troubleshooting

Inspecting the ForceTriad Energy Platform .....................................................................................................7-1

Responding to System Errors............................................................................................................................7-2

System Error Descriptions ........................................................................................................................7-2

Non-Recoverable Error Descriptions.......................................................................................................7-2

Chapter 8. Replacement Procedures

Fuse Replacement...............................................................................................................................................8-2

Battery Replacement...........................................................................................................................................8-2

Low Voltage Power Supply (LVPS) Replacement..........................................................................................8-3

Footswitch/Audio PCBA Replacement.............................................................................................................8-4

Controller PCBA Replacement ..........................................................................................................................8-5

High Voltage DC (HVDC) PCBA Replacement...............................................................................................8-6

Front Panel Replacement...................................................................................................................................8-7

RF PCBA Replacement ......................................................................................................................................8-8

Steering Relay PCBA Replacement..................................................................................................................8-9

Display PCBA Replacement.............................................................................................................................8-11

Barcode Scanner Replacement.......................................................................................................................8-12

Output Receptacle Replacement.....................................................................................................................8-13

Chapter 9. Maintenance and Repair

Responsibility of the Manufacturer....................................................................................................................9-2

Routine Maintenance...........................................................................................................................................9-2

Cleaning.................................................................................................................................................................9-3

Product Service....................................................................................................................................................9-3

Returning the Energy Platform for Service .............................................................................................9-3

Adjustment to Factory Specification (Calibration)...........................................................................................9-4

ForceTriad Service Manual ix

Software Upgrades..............................................................................................................................................9-4

Service Centers....................................................................................................................................................9-4

Chapter 10. Service Parts

Ordering Replacement Parts............................................................................................................................10-1

Chassis Assembly.............................................................................................................................................. 10-2

Shield PCBAs.....................................................................................................................................................10-6

Front Panel..........................................................................................................................................................10-8

Display LCD PCBA..........................................................................................................................................10-10

Steering Relay PCBA......................................................................................................................................10-11

Receptacles...................................................................................................................................................... 10-12

RF PCBA...........................................................................................................................................................10-15

Footswitch/Audio PCBA..................................................................................................................................10-18

HVDC PCBA.....................................................................................................................................................10-22

Controller PCBA...............................................................................................................................................10-25

Cable Assemblies............................................................................................................................................ 10-26

x ForceTriad Service Manual

Chapter

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.

ForceTriad Service Manual 1-1

ForceTriad Energy Platform Front Panel

Monopolar 1 and Accessory Touchscreen

Monopolar 2 and Bipolar Touchscreen

LigaSure and System Tray Touchscreen

Power Switch

Monopolar 1 Instrument Receptacle

Universal Footswitching Accessory Receptacle

Introduction

List of Components

LigaSure 1

Monopolar 2 Instrument

REM Patient Return Electrode Receptacle

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 ForceTriad energy platform is a self-contained unit, consisting of a main enclosure (cover and base) and power cord. The main components are:

• Front panel components

Receptacle

Bipolar Instrument Receptacle

LigaSure 2 Receptacle

Receptacle

• Rear panel components

• Internal components Details about the interaction of the main components and PCBA descriptions are

provided in Chapter 5, Principles of Operation.

1-2 ForceTriad Service Manual

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.

ForceTriad Energy Platform

Overview and General

Up/Down

Next/Back

Back Space

Pressing once increases/decreases the associated value or moves highlighted selection up/down one line. Pressing and holding scrolls up/down.

Progresses/regresses to the next screen.

Regresses one character.

ForceTriad Service Manual 1-3

System Conventions

Symbol Name Description

Bipolar Mute On/Off

Cancel

Enter

System Tray

Turn on/off the audio tones produced by the system that indicate the increase or decrease of current during a bipolar procedure.

Cancels current screen and returns to the previous screen.

Accepts and initiates current selections.

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 icon on a yellow background overlays the screen when error warnings have been disabled using the service menu. The generator will not alarm or give error conditions when this symbol is activated. Touching the screen removes the icon for five seconds.

Note: Additional information on symbols may be found in the Technical

Specifications chapter in this manual.

1-4 ForceTriad Service Manual

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.

ForceTriad Energy Platform

Overview and General

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.

Note: When using Autobipolar, the tissue in the grasp of the bipolar device must

have an impedance within 20 Ω and 1,000 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.

ForceTriad Service Manual 1-5

Power Modes

LigaSure Mode

The LigaSure tissue fusion mode can be used on arteries, veins, pulmonary vasculature, 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.

Warning

Do not attempt to fuse lung tissue with LigaSure mode or instruments.

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.

1-6 ForceTriad Service Manual

Chapter

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.

ForceTriad Service Manual 2-1

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.

2-2 ForceTriad Service Manual

General

Warning

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.

Patient and Operating Room

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.

Safety

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.

a. U.S. Department of Health and Human Services. National Institute for

Occupational Safety and Health (NIOSH). Control of Smoke from Laser/Electric Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128, September, 1996.

ForceTriad Service Manual 2-3

General

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.

Fire/Explosion Hazard

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.

2-4 ForceTriad Service Manual

General

Warning

Fire Hazard 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

Use of electrosurgery in O Therefore, take measures to reduce the O

Avoid enriched O Both O2 and N2O support combustion and may result in fires and burns to patients or surgical personnel.

If possible, stop supplemental oxygen at least one minute before and during use of electrosurgery.

Do not activate the energy platform until flammable vapors from skin prep solutions and tinctures have dissipated.

Avoid the accumulation of naturally occurring flammable gases that may accumulate in body cavities such as the bowel.

Prevent pooling of flammable fluids and 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.

and nitrous oxide (N2O) atmospheres near the surgical site.

rich environments increases the risk of fire.

) enriched environments.

concentration at the surgical site.

Patient and Operating Room

Safety

Fire Hazard During Oropharyngeal Surgery

Verify endotracheal tubes are leak free and that the cuff seals properly to prevent oxygen leaks.

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 O2 with separate suction.

Energy Platform

Warning

Each instrument receptacle on this energy platform is designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a receptacle. Doing so will cause simultaneous activation of the instruments. Follow the instructions provided with electrosurgical instruments for proper connection and use.

Caution

Do not stack equipment on top of the energy platform or place the energy platform on top of electrical equipment. This is an unstable configuration and does not allow for adequate cooling.

ForceTriad Service Manual 2-5

General

Caution

Provide as much distance as possible between the energy platform and other electronic equipment (such as monitors). Do not cross or bundle electronic device cords. This energy platform may cause interference with other electronic equipment.

Active instruments

Caution

Read the instructions, warnings, and cautions provided with electrosurgical instruments before using. Specific instructions for electrosurgical instruments are not included in this manual.

Inspect instruments and cords for breaks, cracks, nicks, and other damage before every use. If damaged, do not use. Damaged instruments or cords may result in injury or electrical shock to the patient or surgical team.

Use only instruments that can withstand the maximum output (peak) voltage for

each output mode as listed in the Technical Specifications chapter in this manual.

Using an instrument with a voltage rating that is lower than the maximum output voltage may result in injury to the patient or the operator, or damage to the instrument.

All Valleylab instruments have voltage ratings that are greater than the maximum output voltages in the ForceTriad energy platform and are thus fully compatible.

Information on voltage ratings for non-Valleylab instruments should be obtained from the instrument’s manufacturer.

Pacemakers and ICDs

Warning

Use electrosurgery and tissue fusion with caution in the presence of internal or external pacemakers. Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the pacemaker manufacturer or hospital cardiology department for further information when use of electrosurgery or tissue fusion appliances is planned in patients with cardiac pacemakers.

If the patient has an implantable cardioverter defibrillator (ICD), contact the ICD manufacturer for instructions before performing an electrosurgical or tissue fusion procedure. Electrosurgery or tissue fusion may cause multiple activations of ICDs.

2-6 ForceTriad Service Manual

Monopolar

After Surgery

Warning

Electric Shock Hazard Always turn off and unplug the energy platform before

cleaning.

Caution

Do not reprocess, reuse or resterilize instruments labeled “disposable” or “single use only.”

Notice

Do not clean the energy platform with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the energy platform.

Patient and Operating Room

Monopolar

Safety

Warning

Simultaneously activating suction/irrigation and electrosurgical current may result in increased arcing at the electrode tip, burns to unintended tissues, or shocks and burns to the surgical team.

Some surgeons may elect to “buzz the hemostat” during surgical procedures. It is not recommended, and the hazards of such a practice probably cannot be eliminated. Burns to the surgeon’s hands are possible. To minimize the risk take these precautions:

• Do not “buzz the hemostat” with a needle electrode.

• Do not lean on the patient, the table, or the retractors while buzzing the hemostat.

• Activate cut rather than coag. Cut has a lower voltage than coag.

• Firmly grasp as much of the hemostat as possible before activating the energy platform. This disperses the current over a larger area and minimizes the current concentration at the finger tips.

• “Buzz the hemostat” below hand level (as close as possible to the patient) to reduce the opportunity for current to follow alternate paths through the surgeon’s hands.

• Use the lowest power setting possible for the minimum time necessary to achieve hemostasis.

• Activate the energy platform after the instrument makes contact with the hemostat. Do not arc to the hemostat.

• When using a coated or nonstick blade electrode, place the edge of the electrode against the hemostat or other metal instrument.

ForceTriad Service Manual 2-7

Monopolar

Patient Return Electrodes

Warning

Do not attempt to use patient return electrodes that disable the REM system. The ForceTriad energy platform’s REM system will function correctly only with contact quality monitoring (CQM) split-style patient return electrodes. Any other patient return electrode products may cause patient injury or product damage.

The safe use of monopolar electrosurgery requires proper placement of the patient return electrode. To avoid electrosurgical burns beneath the patient return electrode, follow all directions provided with the product.

Do not cut a patient return electrode to reduce its size. Patient burns due to high current density may result.

A patient return electrode is not necessary in bipolar or LigaSure procedures.

To avoid patient burns, ensure that the patient return electrode firmly and completely contacts the skin. Always check the patient return electrode periodically and after the patient is repositioned and during procedures involving long periods of activation.

Use of duty cycles greater than 25% (10 seconds active followed by 30 seconds inactive) will increase the risk that heat build-up under a return electrode may be high enough to injure the patient. Do not continuously activate for longer than one minute.

Notice

Capacitive pads and other non-CQM patient return electrodes may not work with the ForceTriad energy platform.

Important

A statement of compatibility from the CQM patient return electrode manufacturer should be obtained prior to the use of a non-Valleylab CQM patient return electrode.

Inadvertent Radio Frequency (RF) Burns

Warning

Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar equipment) can provide a path for high frequency current even if the electrodes or probes are isolated at 50-60 Hz, insulated, and/or battery operated.

Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent electrosurgical burns may result.

To reduce the risk of an inadvertent electrosurgical burn at the electrode or probe site, place the electrode and/or probe as far away as possible from the electrosurgical site and/or patient return electrode. Protective impedances (resistors or RF inductors) installed in the monitoring leads may reduce the risk of such burns. Consult the hospital biomedical engineer for further information.

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Bipolar

Warning

In some circumstances, the potential exists for alternate site burns at points of skin contact (e.g., between the arm and the side of the body). This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin-to-skin contact point. Current passing through small skin-to-skin contact points is concentrated and may cause a burn. This is true for ground referenced and isolated output electrosurgical energy systems.

To reduce the potential for alternate site burns, do one or more of the following:

• Avoid skin-to-skin contact points, such as fingers touching leg or knee touching knee when positioning the patient.

• Place insulation, such as dry gauze or towel, between contact points to ensure that contact does not occur.

• Position the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin-to-skin contact areas.

• In addition, place patient return electrodes according to the manufacturer’s instructions.

Patient and Operating Room

Safety

Bipolar

LigaSure

Caution

Bipolar instruments must be connected to the bipolar instrument receptacle only. Improper connection may result in inadvertent system activation.

Warning

LigaSure instruments are intended for use ONLY with the Valleylab ForceTriad energy platform and the Valleylab LigaSure vessel sealing system. Use of these instruments with other Valleylab generators or with generators produced by other manufacturers may not result in electrical output for which these instruments were designed and thus may not result in the desired clinical effect.

If the seal cycle complete tone has not sounded, an optimal seal may not have been achieved. Reactivate the RF energy until a seal complete tone is heard.

The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

Use caution during surgical cases in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.). For best results, apply the seal to unaffected vasculature.

Do not activate the energy platform in the LigaSure mode until the tissue fusion instrument has been applied with the proper pressure. Activating the energy platform before this is done will result in an improper seal and may increase thermal spread to tissue outside the surgical site.

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LigaSure

Warning

Tissue fusion requires the application of RF energy and pressure from the instrument. Tissue to be sealed must be firmly grasped between the instrument jaw electrodes. Tissue in the jaw hinge or outside the instrument jaw will not be sealed even if thermal blanching occurs.

Do not use LigaSure instruments on vessels in excess of 7 mm in diameter.

LigaSure instruments that require single use electrodes must be used with the correct electrode type. Use of these instruments with any other electrodes could result in injury to the patient or surgical team, or cause damage to the instrument.

Conductive fluids (e.g, blood or saline) in direct contact with LigaSure instruments or in close proximity may carry electrical current or heat, which may cause unintended surgical effects or burns.

Caution

Energy based devices, such as electrosurgical pencils or ultrasonic scalpels, that are associated with thermal spread should not be used to transect seals.

Avoid placing fingers in the handle ratchet mechanism. Injury to the user may result.

LigaSure in Laparoscopic Procedures

Warning

For laparoscopic procedures, be alert to these potential hazards:

• The external surfaces of the LigaSure instrument jaws may remain hot enough to cause burns after the RF current is deactivated.

• Inadvertent activation or movement of the activated LigaSure instrument outside of the field of vision may result in injury to the patient.

• Do not activate the instrument while the instrument jaws are in contact with, or in close proximity to, other instruments including metal cannulas, as localized burns to the patient or physician may occur.

• Do not activate the LigaSure function in an open circuit condition. Activate the energy platform only when the instrument is near or in direct contact with the target tissue to reduce the possibility of unintended burns.

• Carefully insert and withdraw LigaSure instruments from cannulas to avoid possible damage to the devices and/or injury to the patient.

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Servicing

Warning

Electric Shock Hazard Do not remove the energy platform cover. Contact

authorized personnel for service.

Notice

Refer to this system’s service manual for maintenance recommendations and function and output power verification procedures.

Shunt Cords

Warning

Some surgical instruments (e.g., colonoscopes) may allow substantial leakage current that could burn the surgeon. If the instrument manufacturer recommends the use of a shunt cord (s-cord) to direct the current back to the energy platform, you must also use a Valleylab E0507-B adapter. To avoid a REM alarm, you must use a REM patient return electrode with the E0507-B adapter.

Procedures Where Conductive Fluid is Introduced into the Surgical Site

Warning

When this energy platform is used in procedures where conductive fluid (saline or lactated Ringers) is introduced into the surgical site for distention or to conduct RF current, higher than normal currents (greater than one amp) may be

produced. In this situation, use one or more adult-size return electrodes. Do not

use return electrodes labeled for children, infants, babies, neonatal use, or pediatric use.

Patient and Operating Room

Safety

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Laparoscopic Procedures

Warning

For laparoscopic procedures, be alert to these potential hazards:

• Laparoscopic surgery may result in gas embolism due to insufflation of gas in the abdomen.

• The electrode tip may remain hot enough to cause burns after the electrosurgical current is deactivated.

• Inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient.

• Localized burns to the patient or physician may result from electrical currents carried through conductive objects (such as cannulas or scopes). Electrical current may be generated in conductive objects through direct contact with the active electrode, or by the active instrument (electrode or cable) being in close proximity to the conductive object.

• Do not use hybrid trocars that have a non-conductive locking anchor placed over a conductive sleeve. For the operative channel, use all metal or all plastic systems. At no time should electrical energy pass through hybrid systems. Capacitive coupling of RF current may cause unintended burns.

• When using laparoscopic instrumentation with metal cannulas, the potential exists for abdominal wall burns to occur due to direct electrode contact or capacitive coupling of RF current. This is most likely to occur in instances where the energy platform is activated for extended periods at high power levels inducing high current levels in the cannula.

• Ensure that the insulation of single use and reusable laparoscopic instrumentation is intact and uncompromised. Compromised insulation may lead to inadvertent metal-to-metal sparking and neuromuscular stimulation and/or inadvertent sparking to adjacent tissue.

• Do not activate electrodes while in contact with other instruments as unintended tissue injury may occur.

Do not activate the energy platform in an open circuit condition. To reduce the chances of unintended burns, activate the energy platform only when the active electrode is near or touching the target tissue.

• Use the lowest power setting that achieves the desired surgical effect and use a low voltage waveform (Pure Cut, Blend, or Valleylab mode) to lessen the potential for the creation of capacitive currents.

• Carefully insert and withdraw active electrodes from cannulas to avoid possible injury to the patient or damage to the devices.

Valleylab recommends against the use of laparoscopic surgery on pregnant patients.

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System Setup

This chapter describes the how to set up the energy platform, turn it

on, and configure system settings.

Read all warnings, cautions, and instructions provided with this system before use.

Chapter

Caution

Read the instructions, warnings, and cautions provided with electrosurgical instruments before use. Specific instructions for electrosurgical instruments are not included in this manual.

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Setup

Before Startup

1. Verify the system is off by pressing the power switch off (O).

2. Place the energy platform on a flat, stable surface such as a table, platform,

boom system, or Valleylab cart. Carts with conductive wheels are recommended. Refer to the procedures for your local institution or your local codes.

3. Plug the system power cord into the rear panel receptacle.

4. Plug the system power cord into a grounded power receptacle.

Note: Do not plug into a power strip or extension cord.

Powering Up the ForceTriad Energy Platform

1. Turn on the system by pressing the power switch on ( | ). Observe the

following during the power-up self test:

• The ForceTriad logo will appear on all three screens.

System Functions

• A status bar indicates activity.

• An hourglass icon indicates activity after the status bar disappears.

• A tone will sound upon completion of self-test.

2. If the system does not pass the power-up self test, refer to Chapter 7,

Troubleshooting.

Adjusting Display Brightness

The ForceTriad energy platform screens have two levels of brightness. Touch the brightness icon on the right side of the right touchscreen to adjust the display brightness.

The high and low brightness settings can be changed in Brightness Calibration as explained on page 6-19.

Activation Log

The Activation Log allows the user to view the last 1000 activations and REM alerts.

1. Touch the wrench icon on the right side of the right touchscreen. The main

menu display will appear in the left touchscreen.

2. T ouch Activation Log in the main menu. The activation log will appear on the

center touchscreen.

3. Touch the single up or down arrows to the right of the activation log to scroll

through the log one line at a time.

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