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LS0300
User’s Manual
68 pgs1.96 Mb0

Medtronic LS0300 Service Manual

Service Manual
ValleylabTM LS10
LS Series Single Channel Vessel Sealing Generator
Service Manual
ValleylabTM LS10
LS Series Single Channel Vessel Sealing Generator
For use with software version 1.1x
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 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator only. Additional information is available in the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator User’s Guide.
Additional technical information may be available from Covidien Technical Service.
For a complete list of service centers world wide, please refer to the Covidien web site: http://surgical.covidien.com/service-centers.
Equipment covered in this manual:
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator with software version
1.1x.
Conventions Used in this Guide
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Precaution
Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.
Notice
Indicates a hazard which may result in product damage.
Important
Indicates an operating tip or maintenance suggestion.
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:
ValleylabTM LS 10, LS Series Single Channel Vessel Sealing Generator
All purchased or supplemental 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 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.
One year from date of shipment
90 days from delivery
Software License
Covidien llc, (collectively called “COVIDIEN” herein) owns 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, 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.
Except for the limited license rights expressly granted in this Software License, COVIDIEN reserves all rights in and to the Software and any modifications thereto and derivations thereof, including, but not limited to, all title, ownership, intellectual property rights and all other rights and interests. Customer will own only the hardware or physical media on which the Software is stored or processed, if any.
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 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 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.
Table of Contents
LS Series Single Channel Vessel Sealing Generator . . . . . . . . . . . . i
For use with software version 1.1x . . . . . . . . . . . . . . . . . . . . . . . . . i
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Chapter 1. Introduction
Overview and General Features . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Generator Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Generator Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
LigaSure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
LigaSure Instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Chapter 2. Technical Specifications
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Operating Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Internal Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Audio Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Activation Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Alert Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
USB Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Potential Equalization Conductor . . . . . . . . . . . . . . . . . . . . 2-5
Low-Frequency (50/60 Hz) Leakage Current
(IEC 60601-2-2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
High-Frequency (RF) Leakage Current . . . . . . . . . . . . . . . . . 2-6
Input Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Power Cord Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Input Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Input Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Backup Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
ECG Blanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Standards and IEC Classifications . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual vii
Class I Equipment (IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Type CF Equipment (IEC 60601-1)/Defibrillator Proof . . . . . . . 2-11
Liquid Spillage (IEC 60601-2-2:2006 Clause 44.3
and IEC 60601-2-2:2009 Clause 201.11.6.3). . . . . . . . . . . . . . . . 2-11
Voltage Transients (Emergency System Mains Transfer) . . . . . 2-11
Electromagnetic Compatibility (IEC 60601-1-2
and IEC 60601-2-2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Output Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Maximum Output for LigaSure Mode . . . . . . . . . . . . . . . . 2-18
Radio Frequency Identification (RFID) Module Specifications 2-19
Output Power Versus Resistance Graphs . . . . . . . . . . . . . . . . . 2-20
Chapter 3. Setup, Tests, and Adjustments
First-Time Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Setting Up the Valleylab Single Channel
Vessel Sealing Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Valleylab Generator Service Mode . . . . . . . . . . . . . . . . . . . . . . . 3-3
Periodic Safety Check (Routine Maintenance) . . . . . . . . . . . . . . 3-4
Recommended Test Equipment . . . . . . . . . . . . . . . . . . . . . . 3-5
Inspecting the System and Accessories. . . . . . . . . . . . . . . . . 3-6
Inspecting the Internal Components . . . . . . . . . . . . . . . . . . 3-7
Testing the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Safety Testing in Accordance with IEC601-1 . . . . . . . . . . . . . . 3-11
Docking to Valleylab Exchange . . . . . . . . . . . . . . . . . . . . . 3-13
Preventive Maintenance Check Sheet. . . . . . . . . . . . . . . . . . . . 3-14
High-Frequency Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Optional Service Applications . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Power Curve Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Instrument Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Check System Voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Configuration Information . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Retrieving Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Chapter 4. Principles of Operation
Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Functional Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Chapter 5. Troubleshooting
General Troubleshooting Guidelines . . . . . . . . . . . . . . . . . . . . . 5-2
Correcting Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Error and Event Code Strings . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Error List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Events List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Chapter 6. Replacement Procedures
Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Removing the Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Reinstalling the Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
PCBA Display Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
ASSY RFID/Barcode Module Replacement . . . . . . . . . . . . . . 6-4
ASSY Receptacle LigaSure Replacement . . . . . . . . . . . . . . . 6-5
ASSY Cable to Power Supply to Main PCBA Replacement . 6-5
Control Cable Main PCBA to Power Supply Replacement . 6-5
Fuse 250 VAC 8A RoHS Replacement . . . . . . . . . . . . . . . . . . 6-6
Battery - Lithium COIN 3V 16 mm Replacement . . . . . . . . . 6-6
Rubber Foot for Chassis Replacement . . . . . . . . . . . . . . . . . 6-7
USB Cover Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Power Cord Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Power Entry with Cable Replacement . . . . . . . . . . . . . . . . . 6-7
Power Supply Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Volume Control Cable Replacement . . . . . . . . . . . . . . . . . . 6-8
Footswitch Cable Replacement. . . . . . . . . . . . . . . . . . . . . . . 6-9
PCBA PROG MAIN Replacement . . . . . . . . . . . . . . . . . . . . . . 6-9
Fan with Cable Replacement . . . . . . . . . . . . . . . . . . . . . . . 6-10
Speaker Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Display Board Cable Replacement . . . . . . . . . . . . . . . . . . . 6-11
Assembly Back Panel Replacement. . . . . . . . . . . . . . . . . . . 6-12
Chapter 7. Maintenance and Repair
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . 7-2
Routine Maintenance and Periodic Safety Checks. . . . . . . . . . . 7-2
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Product Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Returning the System for Service . . . . . . . . . . . . . . . . . . . . . 7-3
Adjustment to Factory Specification (Calibration). . . . . . . . . . . 7-4
Software Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Covidien Technical Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Chapter 8. Service Parts
Ordering Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Replacement Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Replacing Cable Assemblies . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Chapter 1
Introduction
This chapter provide an overview of the features and functions of the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator.
Precaution
Read all warnings, precautions, and instructions provided with this system before use.
Read the instructions, warnings, and precautions provided with electrosurgical instruments before use. Specific instructions for electrosurgical instruments are not included in this manual.
Overview and General Features
The generator is designed to provide a vessel sealing application. It features a simple interface and automatically detects LigaSure instruments and configures the generator accordingly. Safety and diagnostic functionality include automatic fail-safe functions.
The generator is a bipolar electrosurgical generator with no neutral electrode needed and works with LigaSure instruments as a system. Covidien offers a selection of LigaSure instruments that are fully compatible with this generator. The generator supports only compatible Covidien LigaSure instruments.
Indications for Use
The Valleylab LS10 is an electrosurgical generator containing LigaSure vessel sealing technology. The vessel sealing function is indicated for use in sealing (fusing) vessels up to, and including, 7 mm in diameter, tissue bundles, and lymphatics during general surgery including, but not limited to, surgical specialties such as urologic, vascular, and colorectal etc.
Refer to each instrument’s instructions for use (IFU) for additional indications, warnings, and specific contraindications.
The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
Indications for Use
Introduction
Indications for Use
Generator Front Panel
2
1
3
4
LigaSure
5
Power button – Power on: Push and release.
Power off: Push and hold for 3 seconds.
System error indicator - Lights up as shown upon a system error in the
generator. Restart the generator. If the error occurs again, contact local technical service or Covidien Technical Service.
System error indicator -
•White:
•In motion - System is performing a self test.
•Constant - Ready for use, insert LigaSure instrument.
•Flashing - System in service mode, power cycle system for clinical use.
•Purple - Ready for sealing/seal cycle complete.
•Purple in motion - Sealing in process.
•Amber - Seal cycle incomplete alert. Inspect, regrasp, and reactivate sealing and complete the seal cycle.
6
Usage limit indicator - When illuminated, indicates the inserted device has
already been used. It has not been recertified by the original manufacturer.
Instruments status or switch stuck indicator -
•Red - Instrument error or hand/footswitch stuck. Instrument may be invalid, damaged, or incompatible. Check that compatible LigaSure instrument is in proper working condition and no activation switches are depressed.
Instrument port - Connect LigaSure instruments when the system status indicator
is white.
Generator Back Panel
Indications for Use
Introduction
1
9
7
8
23
Volume knobFootswitch portSerial labelPotential equalization conductor terminalAC fuseAC mains receptacleECG blanking connectorUSB portVent
Warning: Risk of Fire.
Replace Fuse as Marked.
250V, F8.0A (100-240)
4
5
6
Indications for Use
LigaSure Mode
The LigaSure vessel sealing 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 is designed to produce minimal sticking, charring, and thermal spread to adjacent tissue.
Warning
Do not attempt to fuse lung tissue with LigaSure mode or instruments without consulting the respective instructions for use to ensure the use is indicated.
LigaSure Instruments
The LigaSure instruments that complete the Valleylab vessel sealing system include reusable and single-use instruments for open and minimally-invasive procedures. Refer to each instrument’s instruction for use (IFU) for additional indications, warnings, and specific contraindications. The LigaSure function is only available when using Covidien LigaSure instruments.
The footswitch will be disabled upon insertion for some LigaSure instruments. To determine which instrument this applies to, conduct the following:
1. Connect a LS0300 (purple) footswitch to the rear panel footswitch connector.
2. Insert a LigaSure instrument into the LigaSure receptacle on the front panel.
3. Attempt to activate the footswitch.
4. If there is an “invalid activation” tone, it may indicate a disabled footswitch for that particular instrument.
Warning
A failure of the LS10 could result in an unintended increase of output power.
Chapter 2
Technical Specifications
All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ± 20% of a stated value at room temperature (25° C/77° F) and a nominal line input voltage.
Precaution
Read all warnings, precautions, and instructions provided with this system before use.
Read the instructions, warnings, and precautions provided with electrosurgical instruments before use. Specific instructions for electrosurgical instruments are not included in this manual.
Performance Characteristics
Performance Characteristics
General
Output configuration Isolated output, bipolar electrosurgical generator
Cooling Natural and forced convection
Display System Status Indicator - circle LED (12 blocks)
shows system status System Error Indicator - triangle LED with exclamation mark Instrument Status Indicator - LED above the LigaSure receptacle Usage Limit Indicator - 2 with a line through it
Mounting
A Covidien cart (UC8009) or a stable, flat surface
Dimensions and Weight
Width 300 mm (11.81 inches)
Depth 377 mm (14.84 inches)
Height 105 mm (4.13 inches)
Weight 5 kg (11 lbs)
Operating Parameters
Performance Characteristics
Ambient temperature range
Relative humidity 30% to 75% non-condensing
Atmospheric pressure 700 millibars to 1060 millibars
Warm-up time If transported or stored at temperatures outside the
+10C to +40C (50° F to 104° F)
operating temperature range, allow one hour for the system to reach room temperature before use.
Transport and Storage
Ambient-temperature range
Relative humidity 25% to 85% (non-condensing)
Atmospheric pressure 500 millibars to 1060 millibars
Duration of storage If the energy platform is stored for over one year
-30° C to +65° C (-22° F to 149° F)
complete a periodic safety check. Contact Covidien Service for information.
Technical Specifications
Duty Cycle
Under maximum-output settings and rated-load conditions (30 ohm load) the generator is suitable for activation times 5 seconds on, 15 seconds off, for one hour. With lesser settings and loads, you can activate the generator for greater durations without generating excessive internal temperatures.
Internal Battery
Battery for Real Time Clock
Battery type – 3 V lithium button cell
Battery life – 5 years
Performance Characteristics
Audio Volume
The stated audio levels are at a distance of one meter. Alert tones meet the requirements of IEC 60601-2-2.
Activation Tone
The audio levels stated below are for activation tones and alert tones at a distance of one meter.
Volume (adjustable) 45 dBA minimum
Frequency Sealing in process – 440 Hz
Duration Continuous while the system is activated
Alert Tone
Volume (not adjustable)
Duration
65 dBA minimum
Seal cycle incomplete alert – The LigaSure regrasp alert is four tones played for 150 ms each with no break be­tween tones. The order and frequency of the tones is 784 Hz, 587 Hz, 784 Hz, 587 Hz
High, low, high, low
Seal cycle complete tone – Two tones played for175 ms each at 985 Hz with a 175 ms break between the tones
System error tone – Three 200 ms tones separated by 300 ms for each error/system-alert event
Performance Characteristics
USB Port
The software provides an asynchronous serial-communications interface for communicating with an externally-connected device. Equipment connected to the USB port shall comply with IEC 60950 safety of IT equipment. The USB data port is accessible behind the USB/ECG Blanking Port cover on the rear panel. This cover is removed using a tool to access the USB port.
USB B-type connector, configured as a serial/COM port with 115200 bps baud, 8 data bits, 1 stop bit, no flow control setting in the laptop.
Precaution
USB Port access should only be performed outside the surgical setting with no patient contact. Replace the port cover before surgical use.
Potential Equalization Conductor
Technical Specifications
A Potential Equalization Conductor providing a direct connection between the Valleylab Generator and the potential equalization busbar of the electrical installation.
Low-Frequency (50/60 Hz) Leakage Current (IEC 60601-2-2)
Enclosure source current, ground open
Source current, patient leads, all outputs
Sink current at high line, all inputs
< 300 μA
Normal polarity, intact ground: < 10 μA
Normal polarity, ground open: < 50 μA
Reverse polarity, ground open: < 50 μA
Mains voltage on applied part: < 50 μA
< 50 μA
Performance Characteristics
High-Frequency (RF) Leakage Current
LigaSure leakage Measured with leads
recommended by Covidien
LigaSure (left tine)
LigaSure (right tine)
< 116 mA < 100 mA
< 116 mA < 100 mA
Measured directly at the system terminals
Input Power
120 Volt 240 Volt
Maximum power at nominal line voltage: Idle: 35 VA Seal: 400 VA
Full regulation range: 90 to 130 Vac Full regulation range: 180 to 240 Vac
Operating Range: 100 to 120 Vac Mains current maximum: Idle: 389 mA Seal: 4.44 A
rms
rms
Maximum power at nominal line voltage: Idle: 35 VA Seal: 400 VA
Operating Range: 210 to 240 Vac Mains current maximum: Idle: 194 mA Seal: 2.22 A
rms
rms
Mains line frequency range (nominal) 50 to 60 Hz
Fuses (2) – 5 mm x 20 mm 8 A, 250 V fast blow, high breaking capacity
Power plug: 3-prong hospital-grade connector
Mains line frequency range (nominal) 50 to 60 Hz
Fuses (2) – 5 mm x 20 mm 8 A, 250 V fast blow, High breaking capacity
Power plug: 3-prong locally-approved connector
Power Cord Specification
This system is factory equipped with a 220 VAC hospital-grade NEMA 5-15 power cord. Should the AC power cord need to be replaced to match another plug configuration, the replacement plug/cable/receptacle configuration must meet or exceed the following specifications:
Performance Characteristics
100-120 VAC
Cable - SJT16/3, IEC color code, maximum length 15 ft. (5 m) Plug - minimum 10 A - 125 VAC Unit receptacle - IEC female, minimum 10 A - 125 VAC
210-240 VAC
Cable - H05VVF3G1.0 VDE, maximum length 15 ft. (5 m) Plug - minimum 6 A - 250 VAC
Unit receptacle - IEC female, minimum 6 A - 250 VAC
Important
Contact your local Covidien representative for alternative internationally approved power-cord options.
Technical Specifications
Input Frequency
The system operates within specification at all line-input frequencies between 48 Hz and 62 Hz. The user does not need to reconfigure the system for different line frequencies.
Input Current
The generator draws no more than 8 A at input voltages between 100 V and 240 V.
Backup Power
The generator retains all user-programmed features, calibration, and statistical data when switched off and unplugged. The energy platform operates within specification when switched over to a supplied-line power by hospital backup systems.
ECG Blanking
An ECG blanking port is provided to signal other devices that the generator is active. The receptacle is a 2.5 mm mono jack. It is electrically isolated from the internal ground referenced electronics with the shell electrically connected to the chassis for ESD protection. The ECG blanking port is rated: 12 VDC @ 0.2A.
Standards and IEC Classifications
Standards and IEC Classifications
The Valleylab LS10 Generator meets all pertinent clauses of IEC 60601-1 second and 60601-2-2 third editions.
F
The system output is floating (isolated) with respect to ground.
DANGER
Explosion risk if used with flammable anesthetics.
To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel.
Unit produces non-ionizing radiation.
Classified with respect to electrical shock, fire, and mechanical haz­ards only in accordance with UL standard 60601-1; certified to CSA standard C22.2 No. 601.1.
Symbols
Symbols
Catalogue number
Technical Specifications
Consult instructions for use
Manufacturer
Authorized representative in the European community
Date of manufacture
Footswitch
Alternating current
Potential equalization conductor terminal
Symbols
-22°F
-30°C Temperature
limit
149°F 65°C
Serial number
Not made with natural rubber latex
Temperature limitations
25%
Humidity limitation
ME20
85%
Humidity limitations
For sale by prescription only
Eurasian conformity mark
Russian GOST-R
CE mark and notified body number
Volume adjustment for activation tones
Class I Equipment (IEC 60601-1)
Equipment should not be disposed in trash. Dispose of this product according to local regulation.
Class I Equipment (IEC 60601-1)
Accessible conductive parts cannot become live in the event of a basic insulation failure due to the way in which they are connected to the protective earth conductor.
Type CF Equipment (IEC 60601-1)/Defibrillator Proof
This generator provides a high degree of protection against electric shock, particularly regarding allowable leakage currents. It is type CF isolated (floating) output and may be used for procedures involving the heart.
This generator complies with IEC 60601-1:1988 + A1:1991 + A2:1995 and IEC 60601­1:2005 specifications for “defibrillator proof” designation and IEC 60601-2-2:2006 and IEC 60601-2-2:2009.
Technical Specifications
Liquid Spillage (IEC 60601-2-2:2006 Clause 44.3 and IEC 60601-2-2:2009 Clause 201.11.6.3)
The generator is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wetted are likely to adversely affect the safety of the equipment.
Voltage Transients (Emergency System Mains Transfer)
The generator continues to operate normally with no errors or system failures when transfer is made between line AC and an emergency system-voltage source. (IEC 60601­1:1988 + A1:1991 + A2:1995 clause 49, IEC 60601-1:2005 clause 11.8, IEC 60601-2­2:2006 clause 51.101, and IEC 60601-2-2:2009 clause 201.11.8)
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)
The generator complies with the appropriate IEC 60601-1-2 and 60601-2-2 specifications regarding electromagnetic compatibility.
Notice
The generator requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the generator service manual.
Portable and mobile RF communications equipment can affect the generator. Refer to the EMC information provided in the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual.
The system should not be used adjacent to or stacked with equipment other than specified in the
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator User’s Guide and Service Manual. If adjacent or stacked use is necessary, the system should be observed to verify normal
operation in the configuration in which it will be used.
The system intentionally applies RF energy for diagnosis or treatment during activation. Observe other electronic medical equipment in the vicinity during the system activation for any possible adverse electromagnetic effects. Ensure adequate separation of electronic medical equipment based on observed reactions.
The use of accessories, other than specified in the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator User’s Guide and Service Manual, may result in increased emissions or decreased immunity of the system.
Other surgical equipment that generates RF energy may affect the generator. The generator should be observed to confirm normal operation when used simultaneously with other equipment. If an incomplete seal cycle occurs, reactivate the LigaSure instrument.
The generator meets the following requirements:
ESD Immunity (IEC 60601-1-2 sub-clause 36.202 and IEC 61000-4-2)
Radiated Immunity (IEC 60601-1-2 sub-clause 36.202.2 and IEC 61000-4-3)
Electrical Fast Transient/Burst (IEC 60601-1-2 sub-clause 36.202.3.1 and IEC 61000-4-4)
Surge Immunity (IEC 60601-1-2 sub-clause 36.202.3.2 and IEC 61000-4-5)
Emissions (IEC 60601-1-2 sub-clause 36.201.1, IEC 60601-2-2 sub-clause 36 and CISPR 11 Class A)
Harmonic distortion (IEC 60601-1-2 sub-clause 36.201.3.1 and IEC 61000-3-2)
Conducted disturbances (IEC 60601-1-2 sub-clause 36.202.6 and IEC 61000-4-6)
Power frequency magnetic fields (IEC 60601-1-2 sub-clause 36.202.8.1 and IEC 61000­4-8)
Voltage dips, short interruptions and variations (IEC 60601-1-2 sub-clause 36.202.7 and IEC 61000-4-11)
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
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