Covidien ForceTriad Service manual

Service Manual
ForceTriad
Energy Platform
TM
Service Manual
ForceTriad
Energy Platform
TM
Part Number: 1040472
Preface
This manual and the equipment it describes are for use only by qualified personnel trained in the particular technique and surgical procedure to be performed. It is intended as a guide for servicing the Covidien ForceTriad energy platform only. Additional users information is available in the ForceTriad Energy Platform User’s Guide.
Additional technical information may be available from Covidien Technical Service (see page 9-4).
For a complete list of service centers world wide, please refer to the Covidien web site: http://www.valleylab.com
Equipment covered in this manual:
ForceTriad Energy Platform
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.
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Limited Warranty
Covidien warrants each covered product listed below to be free from defects in material and workmanship for normal use and service for the period(s) set forth below. Covidien’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it (or its authorized distributor) within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Covidien’s satisfaction, that the product is defective. This limited warranty does not apply to any product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.
The warranty periods for Covidien products are as follows:
ForceTriadTM Energy Platform One year from date of shipment
Electrosurgical Generators One year from date of shipment
TM
Cool-tip
EvidentTM MWA Generator One year from date of shipment
LigaSure
LigaSure
RFA Generator One year from date of shipment
TM
Vessel Sealing System One year from date of shipment
TM
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
TM
Valleylab
RapidVac
LigaSure
Cool-tip
Argon Gas Delivery Unit II One year from date of shipment
TM
Smoke Evacuator One year from date of shipment
TM
Sterile Single Use Items Sterility only as stated on packaging
TM
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
All purchased or supplemental
90 days from delivery
software programs or updates
Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the products sold hereunder shall be limited to the aggregate purchase price for the products sold to the customer. This limited warranty is non-transferable and runs only to the original purchaser of the
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covered product(s). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of products and for any form of indirect, tort, or consequential damages.
This limited warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes arising under or relating in any way to this limited warranty is the District Court of the County of Boulder, State of Colorado, USA.
Covidien reserves the right to make changes in covered products built or sold by it at any time without incurring any obligation to make the same or similar changes to equipment previously built or sold by it.
THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS
EXPRESSLY PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Software License
COVIDIEN AG, Tyco Healthcare Group LP, and its affiliate EbD (collectively called “COVIDIEN” herein) own the entire right, title, and interest in and to all of the computer programs and all portions thereof, and associated documentation (collectively, the “Software”) provided to Customer as may be installed in the Products and equipment addressed herein or provided separately, and it has the sole right to grant licenses hereunder.
The evaluation allowance herein and any ultimate price paid by Customer for the products incorporating the Software include as a portion of that evaluation allowance, or price, a license fee granting Customer only the rights set forth in this Software License. Customer further acknowledges and agrees that the Software is owned exclusively by COVIDIEN. The Software is licensed to be used on only one computing device or Product, and a valid license must be purchased for each computing device on which the Software is installed.
Single User License Grant: COVIDIEN grants to Customer a limited, nonexclusive, non­sublicensable, nontransferable and revocable license to use the Software, exclusively at Customer’s location as identified by Customer as the ship-to location of the Product, solely in machine-readable object code form only on a single central processing unit owned or leased by Customer or otherwise embedded in equipment provided by COVIDIEN, and for the sole purpose of Customer’s internal business purpose in the operation of the Product or equipment purchased from, other otherwise provided by, COVIDIEN or its affiliates.
Except to the extent expressly authorized in this Software License or by law, Customer shall not and shall not cause any third party to: (i) decompile, disassemble, or reverse engineer the Software; (ii) modify or create any derivative works (including, without limitation, translations, transformations, adaptations or other recast or altered versions) based on the Software, or alter the Software in any way; (iii) merge the Software with any other software or product not supplied by Supplier; (iv) use, copy, sell, sublicense,
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lease, rent, loan, assign, convey or otherwise transfer the Software except as expressly authorized by the Agreement; (v) distribute, disclose or allow use of the Software, in any format, through any timesharing service, service bureau, network or by any other means, to or by any third parties; (vi) remove or modify any copyright, confidential and/or proprietary markings, legends or restriction which are in the Software originally supplied to Customer; or (vii) violate any obligations with regard to COVIDIEN’s Confidential Information. To the extent that Customer is expressly permitted by applicable mandatory law to undertake any of the activities listed in the preceding sentence, Customer will not exercise those rights until Customer has given COVIDIEN thirty (30) days written notice of Customer’s intent to exercise any such rights unless an order of a government agency of competent jurisdiction will not so allow.
Customer agrees that the Software, including the specific design and structure of individual programs, constitute confidential information and trade secrets of COVIDIEN, whether or not the programs may be copyrighted or copyrightable, and/or patented or patentable. Customer agrees not to disclose, provide, or otherwise make available such confidential information, trade secrets or copyrighted material in any form to any third party. Customer agrees that it will make the Software available only to employees, contractors, or consultants with a need to know, who are obligated to comply with all license restrictions contained in this Software License Agreement and to maintain the secrecy of the Software and all other Confidential Information. Customer is responsible for the compliance of all users with these obligations.
Customer may, from time to time, request that COVIDIEN incorporate certain features, enhancements or modifications into the Software. COVIDIEN may, in its sole discretion, undertake to incorporate such changes and distribute the Software so modified to all or any of COVIDIEN's customers. All such error corrections, bug fixes, patches, updates or other modifications provided to COVIDIEN shall be the sole property of COVIDIEN.
This Software License is effective until terminated. Customer may terminate this License at any time by destroying all copies of Software including any documentation. This License will terminate immediately upon notice from COVIDIEN if Customer fails to comply with any provision of this License or any supplier agreement. COVIDIEN may terminate the Software licenses granted herein and exercise all available rights by giving written notice, effective immediately, if within ten (10) business days of Customer’s receipt of a reasonably detailed written request to cure, Customer has not cured all breaches of this License’s limitations or restrictions. Upon such termination, Customer will immediately pay all undisputed fees outstanding, cease use of all Software, return or delete, at COVIDIEN’s request, all copies of the Software in Customer’s possession, and certify compliance with all of the obligations herein to COVIDIEN in writing.
Limited Warranty: COVIDIEN represents and warrants to Customer that the Software will perform substantially as described in COVIDIEN's then current documentation for such Software for the longer of (a) the remaining warranty applicable to the product with which such Software was delivered (not to exceed one year) or (b) ninety (90) days from the date such Software was shipped or first made available to Customer for electronic
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download from COVIDIEN’s service site. If you notify COVIDIEN of defects during the warranty period, COVIDIEN will replace the Software or, at its option, refund the purchase price. Your remedy for breach of this limited warranty shall be limited to replacement or refund and shall not encompass any other damages. No dealer, distributor, agent or employee of COVIDIEN is authorized to make any modification or addition to the warranty and remedies stated above.
Notwithstanding these warranty provisions, all of COVIDIEN's obligations with respect to such warranties shall be contingent on Customer’s use of the Software in accordance with this Agreement and in accordance with COVIDIEN's instructions as provided by COVIDIEN in the documentation, as such instructions may be amended, supplemented, or modified by COVIDIEN from time to time. COVIDIEN shall have no warranty obligations with respect to any failures of the Software which are the result of accident, abuse, misapplication, extreme power surge or extreme electromagnetic field.
This warranty does not apply to any damages, malfunctions, or non-conformities caused to or by: (i) Customer’s use of Software in violation of the license granted under the Agreement or in a manner inconsistent with any provided documentation; (ii) use of non­COVIDIEN furnished equipment, software, or facilities with its equipment or Products; (iii) Customer’s failure to follow COVIDIEN’s installation, operation, repair or maintenance instructions; (iv) Customer’s failure to permit COVIDIEN timely access, remote or otherwise, to Products; (v) failure to implement all new Updates to Software provided under the Agreement; (vi) Products or equipment with their original manufacturer’s serial numbers altered, defaced or deleted; (vii) Products or equipment that have been altered, serviced or modified by a party other than COVIDIEN; or (viii) Software that has been subjected to abnormal physical or electrical stress, misuse, negligence or accident by Customer or a third party.
DISCLAIMER: EXCEPT AS SPECIFIED IN THIS WARRANTY, ALL EXPRESS OR IMPLIED CONDITIONS, REPRESENTATIONS, AND WARRANTIES INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE, ARE HEREBY EXCLUDED TO THE EXTENT ALLOWED BY APPLICABLE LAW.
IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY LOST REVENUE, PROFIT, OR DATA, OR FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY ARISING OUT OF THIS SOFTWARE LICENSE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL ONE PARTY’S LIABILITY TO THE OTHER PARTY, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE PRICE PAID OR TO HAVE BEEN PAID BY CUSTOMER. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF THE ABOVE-STATED WARRANTY FAILS OF ITS ESSENTIAL PURPOSE. SOME STATES DO NOT ALLOW LIMITATION OR EXCLUSION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES.
U.S. Government Rights. The Software is a commercial item developed exclusively at private expense, consisting of “commercial computer software” and “commercial computer software documentation” as such terms are defined or used in the applicable U.S. acquisition regulations. The Software is licensed hereunder (i) only as a commercial item and (ii) with only those rights as are granted to all other customers pursuant to the
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terms and conditions of this License. Customer shall not use, duplicate, or disclose the Software in any way not specifically permitted by this License. Nothing in this License requires COVIDIEN to produce or furnish technical data for or to Customer.
If any provision of this Agreement shall be held by a court of competent jurisdiction to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect.
This License Agreement contains the entire understanding and agreement between the parties respecting the Software. This Agreement may not be supplemented, modified, amended, released or discharged except by an instrument in writing signed by each party's duly authorized representative. All captions and headings in this Agreement are for purposes of convenience only and shall not affect the construction or interpretation of any of its provisions. Any waiver by either party of any default or breach hereunder shall not constitute a waiver of any provision of this Agreement or of any subsequent default or breach of the same or a different kind.
The construction and performance of this Agreement will be governed by the laws of the State of Colorado without reference to its choice of law principles. The parties hereby submit to the jurisdiction of the courts of the State of Colorado.
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Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv
Chapter 1. Overview and General Features
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
ForceTriad Energy Platform Front Panel. . . . . . . . . . . . . . . . . . . 1-3
ForceTriad Energy Platform Back Panel . . . . . . . . . . . . . . . . . . . 1-4
System Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Touchscreens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Common Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Power Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Monopolar Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Bipolar Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
LigaSure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Chapter 2. Patient and Operating Room Safety
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Setting Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Fire/Explosion Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
ForceTriad Energy Platform . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Active Instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Implanted Electronic Devices (IEDs) . . . . . . . . . . . . . . . . . . . 2-6
After Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Monopolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Patient Return Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Inadvertent Radio Frequency (RF) Burns . . . . . . . . . . . . . . . 2-8
Laparoscopic Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Bipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
LigaSure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
LigaSure in Laparoscopic Procedures . . . . . . . . . . . . . . . . . 2-11
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Shunt Cords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Conductive Fluid in the Surgical Site . . . . . . . . . . . . . . . . . . . . 2-12
Chapter 3. Principles of Operation
Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Functional Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
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TissueFect Tissue Sensing Technology . . . . . . . . . . . . . . . . . 3-4
REM Contact Quality Monitoring System . . . . . . . . . . . . . . 3-4
High-Voltage DC (HVDC PCBA) Power Supply Principles
of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
RF PCBA Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
REM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Autobipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Leakage Current Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Sensor Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Steering Relay PCBA Principles of Operation . . . . . . . . . . . . . . . 3-8
Circuit Descriptions for the ForceTriad Display PCBA . . . . . . . . 3-9
Hotlink Transceiver U1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Liquid Crystal Display (LCD) Driver Inside the FPGA U28 . . 3-9
Touchscreen Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Barcode Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Footswitch/Audio PCBA Circuitry Description . . . . . . . . . . . . . 3-10
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Power Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Audio Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Footswitch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Expansion Port DAC Data . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
DAC Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Isolated Footswitch and Expansion Port Circuitry . . . . . . . 3-12
Controller PCBA Principles of Operation . . . . . . . . . . . . . . 3-12
Host Processor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Digital Signal Processor (DSP) Controlled Data Converters 3-13
Interface Control Logic PLD . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Data Converters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
External Peripherals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
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
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Alarm Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
REM Contact Quality Monitor . . . . . . . . . . . . . . . . . . . . . . . 4-5
Autobipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Low-Frequency (50/60 Hz) Leakage Current . . . . . . . . . . . . 4-8
High-Frequency (RF) Leakage Current . . . . . . . . . . . . . . . . . 4-8
Input Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Power Cord Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Input Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Input Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Backup Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Equipotential Ground Connection . . . . . . . . . . . . . . . . . . . 4-10
ECG Blanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Standards and IEC Classifications . . . . . . . . . . . . . . . . . . . . . . . 4-11
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Class I Equipment (IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . 4-13
Type CF Equipment (IEC 60601-1)/Defibrillator Proof . . . . 4-13
Liquid Spillage (IEC 60601-2-2 Clause 44.3) . . . . . . . . . . . . 4-13
Voltage Transients (Emergency System Mains Transfer). . 4-13
Electromagnetic Compatibility (IEC 60601-1-2 and
IEC 60601-2-2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Output Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Maximum Output for Bipolar, Monopolar, and LigaSure
Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Available Power Settings in Watts . . . . . . . . . . . . . . . . . . . 4-20
Output Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Output Power vs. Resistance Graphs. . . . . . . . . . . . . . . . . . . . . 4-24
Monopolar Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Bipolar Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32
Bipolar Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
LigaSure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37
Chapter 5. System Setup
Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Before Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Powering Up the ForceTriad Energy Platform . . . . . . . . . . . 5-2
System Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Adjusting Display Brightness . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Activation Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Service Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
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Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Features Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Demo Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Chapter 6. Setup, Tests, and Adjustments
Setting Up the ForceTriad Energy Platform . . . . . . . . . . . . . . . . 6-2
Calibrating the ForceTriad Energy Platform. . . . . . . . . . . . . . . . 6-4
Periodic Safety Check (Routine Maintenance) . . . . . . . . . . . . . . 6-9
Recommended Test Equipment . . . . . . . . . . . . . . . . . . . . . 6-11
Inspecting the System and Accessories. . . . . . . . . . . . . . . . 6-12
Inspecting the Internal Components . . . . . . . . . . . . . . . . . 6-13
Testing the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Enable Demo Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Entering Debug Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Testing the Low-Voltage Power Supply . . . . . . . . . . . . . . . 6-17
Verifying the Audio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Verifying REM Function . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Verifying Autobipolar Mode . . . . . . . . . . . . . . . . . . . . . . . 6-18
Verifying Cross Coupling. . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Confirming Power Delivery at Receptacle . . . . . . . . . . . . . 6-21
Verifying Power Output . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Checking High-Frequency Leakage Current . . . . . . . . . . . 6-28
Safety Testing in Accordance with IEC601 . . . . . . . . . . . . . . . . 6-29
Checking Low-Frequency Leakage Current . . . . . . . . . . . . 6-30
Ground Bond Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Docking to Valleylab Exchange . . . . . . . . . . . . . . . . . . . . . 6-31
Preventive Maintenance Check Sheet. . . . . . . . . . . . . . . . . . . . 6-32
Chapter 7. Troubleshooting
Inspecting the ForceTriad Energy Platform . . . . . . . . . . . . . . . . 7-2
Responding to System Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
System-Error Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Non-Recoverable Error Descriptions. . . . . . . . . . . . . . . . . . . 7-3
Chapter 8. Replacement Procedures
Removing and Reinstalling the Front Panel . . . . . . . . . . . . . . . . 8-2
Fuse Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Low-Voltage Power Supply (LVPS) Replacement . . . . . . . . . . . . 8-6
Footswitch/Audio PCBA Replacement . . . . . . . . . . . . . . . . . . . . 8-8
Controller PCBA Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
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High-Voltage DC (HVDC) PCBA Replacement . . . . . . . . . . . . . 8-12
RF PCBA Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Steering-Relay PCBA Replacement . . . . . . . . . . . . . . . . . . . . . . 8-16
Display PCBA Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Barcode Scanner Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
Output Receptacle Replacement. . . . . . . . . . . . . . . . . . . . . . . . 8-22
Barcode-Scanner Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25
System Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
System Display Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
System Fans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-31
Scan Stand Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-33
Chapter 9. Maintenance and Repair
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . 9-2
Routine Maintenance and Periodic Safety Checks. . . . . . . . . . . 9-2
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Product Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Returning the System for Service . . . . . . . . . . . . . . . . . . . . . 9-3
Adjustment to Factory Specification (Calibration). . . . . . . . . . . 9-4
Software Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Covidien Technical Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Chapter 10. Service Parts
Ordering Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Replacement Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Replacing Cable Assemblies . . . . . . . . . . . . . . . . . . . . . . . . 10-4
ForceTriad Energy Platform Service Manual xiii
Chapter 1
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 Energy Platform Service Manual 1-1
Introduction
Introduction
The ForceTriad energy platform is designed to provide radio frequency (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 to configure the system accordingly. Safety and diagnostic functionality include automatic fail-safe functions.
The system is a self-contained unit, consisting of a main enclosure (cover and base) and a power cord. Details about the interaction of the main components and PCBA descriptions are provided in Chapter 3, Principles of Operation.
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ForceTriad Energy Platform Front Panel
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6
7
8
9
2
3
1
10
ForceTriad Energy Platform Front Panel
Overview and General Features
Monopolar 1 and Accessory TouchscreenMonopolar 2 and Bipolar TouchscreenLigaSure and System Tray TouchscreenPower SwitchMonopolar-Instrument ReceptacleUniversal-Footswitching-Accessory ReceptacleREM™ Patient Return Electrode ReceptacleBipolar-Instrument ReceptacleMonopolar 2-Instrument ReceptacleLigaSure 1 and 2 Receptacles
ForceTriad Energy Platform Service Manual 1-3
ForceTriad Energy Platform Back Panel
CAUTION
Monopolar
LigaSure 1
LigaSure 2
Bipolar
U.S. and foreign patents pending.
Warning: Risk of Fire.
Replace Fuse as Marked.
250V, F8.0A (100-240)
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2
3
4
5
67
9
10
8
Avertissement: Risque du feu.
Remplacez les fusibles comme marqués.
250 V F8.0A (100-240)
ForceTriad Energy Platform Back Panel
USB PortEthernet PortRS232 PortLigaSure 1 and 2 Footswitch PortBipolar-Footswitch ReceptacleMonopolar-Footswitch Receptacle (requires adapter to connect standard
four-pin monopolar footswitch)
Fuse PortAudio-Volume KnobLink-Cable Port (ECG Receptacle)Expansion Port
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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 illuminate, and the unavailable touchscreens dim.
Common Symbols
Symbol Name Description
System Conventions
Overview and General Features
Page Up/Page Down
Up/Down
Next/Back
Scrolls through blocks of options that cannot be displayed on a single screen.
Pressing once increases/decreases the associated value or moves highlighted selection up/down one line. Pressing and holding scrolls up/down.
Progresses to the next screen, or returns to the previous screen.
Back Space
ForceTriad Energy Platform Service Manual 1-5
Regresses one character.
System Conventions
Symbol Name Description
Bipolar Mute On/Off
Cancel
Enter
System Tray
Turns 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.
Accesses and adjusts system settings including screen brightness and main­menu options as well as a connection indicator.
Brightness
Each selection of this button alternately adjusts between two available brightness settings. When maximum brightness is reached, next selection resets to the least bright setting.
Wrench
Selects access to the Main Menu, which provides user-selected options for language, appearance, and operation.
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Symbol Name Description
Power Modes
Overview and General Features
Connection Indicator
Errors Disabled
Note: Additional information on symbols may be found in Chapter 4, Technical
Specifications.
Indicates active communication with another system such as Valleylab Exchange Remote Software System or a third-party system.
This icon on a yellow background overlays the screen when error warnings have been disabled using the service menu. The system does not alarm or give error conditions when this symbol is activated. Touching the screen removes the icon for five seconds.
Power Modes
As a safety feature, simultaneous activation of multiple instruments is not possible on the system.
Monopolar Modes
The system produces five modes of power output.
Note: To provide expected hand-piece functionality, proper insertion of the hand piece is required. Refer to the orientation drawing on the front of the system for proper insertion orientation.
Cut Modes
Pure cut provides a clean, precise cut in any tissue with little or no hemostasis.
Blend cut is a conventional blended waveform that provides slower cutting with
simultaneous hemostasis.
Valleylab Mode
Valleylab mode is a unique combination of hemostasis and dissection that allows the user to slow down for more hemostasis and speed up for faster dissection. Thermal spread is equal to or less than cut or blend modes.
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Power Modes
Coag Modes
Fulgurate coagulates tissue by sparking from the active electrode, through air, to the
patient tissue. Because 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.
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 does 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.
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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 available only when using LigaSure instruments.
Power Modes
Overview and General Features
ForceTriad Energy Platform Service Manual 1-9
Chapter 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.
ForceTriad Energy Platform Service Manual 2-1
General
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 system only if the power-up self-test has been completed as described in
this manual, otherwise inaccurate power outputs may result.
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 slowly 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 making major power setting adjustments.
Contact between the active electrode and any metal greatly increases current flow and can result in unintended surgical effect.
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Warning
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 non-insulated 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.
General
Patient and Operating Room
Caution
Read all warnings, cautions, and instructions provided with this system 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 system is delivering RF energy.
When using a smoke evacuator in conjunction with the system, set the system volume control at a level that ensures that the activation tones can be heard.
Connect only Covidien-approved footswitches. Using footswitches from other manufacturers may cause equipment malfunction.
A non-functioning system 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
Safety
Inadvertent activation may occur while installing, removing, or bending electrodes. Ensure that the instrument cord is not connected to the system 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 Energy Platform 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 system to the hospital equalization connector with an equipotential cable.
Fire/Explosion Hazard
Warning
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.
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 O2 rich environments increases the risk of fire. Therefore, take measures to reduce the O2 concentration at the surgical site.
Avoid enriched O2 and nitrous oxide (N2O) atmospheres near the surgical site. 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 system 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.
) enriched environments.
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