Valleylab LS10 Service Manual

Service Manual

ValleylabTM LS10

LS Series Single Channel Vessel Sealing Generator

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

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.

ii	Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual

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	One year from date of shipment
Channel Vessel Sealing Generator
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 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.

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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

iv	Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual

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

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual

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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.

vi	Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual

Table of Contents

LS Series Single Channel Vessel Sealing Generator . . . . . . . . . . . . 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 Class I Equipment (IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . 2-11

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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Output Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Maximum Output for LigaSure Mode . . . . . . . . . . . . . . . . 2-17

Radio Frequency Identification (RFID) Module Specifications. 2-18

Output Power Versus Resistance Graphs . . . . . . . . . . . . . . . . . 2-19

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

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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 . . . . . . . . . . . . . . . . . 6-6 USB Cover Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 Power Cord Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 Power Entry with Cable Replacement . . . . . . . . . . . . . . . . . 6-7 Power Supply Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 Volume Control Cable Replacement . . . . . . . . . . . . . . . . . . 6-8 Footswitch Cable Replacement. . . . . . . . . . . . . . . . . . . . . . . 6-9 PCBA PROG MAIN Replacement . . . . . . . . . . . . . . . . . . . . . . 6-9 Fan with Cable Replacement . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Speaker Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 Display Board Cable Replacement . . . . . . . . . . . . . . . . . . . 6-10 Assembly Back Panel Replacement. . . . . . . . . . . . . . . . . . . 6-11

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

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Chapter 1

Introduction

This chapter provides 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 LigaSure™ instruments before use. Specific instructions for electrosurgical instruments are not included in this manual.

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Overview and General Features

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 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, thoracic, gynecologic, plastic and reconstructive, and colorectal.

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.

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Generator Front Panel

Generator Front Panel

2

3

4

5

6 1

LigaSure

Introduction

1.Power button - Power on: Push and release. Power off: Push and hold for 3 seconds.

2.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.

3.System status 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.

4.Usage limit indicator - When illuminated, indicates the inserted device has already been used. It has not been recertified by the original manufacturer.

5.Instrument 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.

6.Instrument port - Connect LigaSure instruments when the system status indicator is white

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Generator Back Panel

Generator Back Panel

1

2

3

4

5

Warning: Risk of Fire.

Replace Fuse as Marked.

250V, F8.0A (100-240)

9	8	7	6

1.Volume knob

2.Footswitch port

3.Serial label

4.Potential equalization conductor terminal

5.AC fuse

6.AC mains receptacle

7.ECG blanking connector

8.USB port

9.Vent

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Generator Back Panel

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.

Introduction

Warning

Do not attempt to fuse lung tissue with LigaSure mode or instruments without first 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.

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual

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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.

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2-1

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)

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Operating Parameters

Ambient temperature	+10° C to +40° C (50° F to 104° F)
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
	operating temperature range, allow one hour for the
	system to reach room temperature before use.

Transport and Storage

Ambient-temperature -30° C to +65° C (-22° F to 149° F) 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 complete a periodic safety check. Contact Covidien Service for information.

Performance Characteristics

Specifications Technical

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	Battery type – 3 V lithium button cell
Clock	Battery life – 5 years

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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	65 dBA minimum
	(not adjustable)
	Duration	Seal cycle incomplete alert – The LigaSure regrasp alert
		is four tones played for 150 ms each with no break be-
		tween 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

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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, enumerated with 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

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	< 300 μA
	current, ground open
	Source current,	Normal polarity, intact ground: < 10 μA
	patient leads, all	Normal polarity, ground open: < 50 μA
	outputs
		Reverse polarity, ground open: < 50 μA
		Mains voltage on applied part: < 50 μA
	Sink current at high	< 50 μA
	line, all inputs

Specifications Technical

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Performance Characteristics

High-Frequency (RF) Leakage Current

LigaSure leakage		Measured with leads	Measured directly at
		recommended by	the system terminals
		Covidien
	LigaSure (left	< 116 mA	< 100 mA
	tine)
	LigaSure (right	< 116 mA	< 100 mA
	tine)

Input Power

120 Volt	240 Volt
Maximum power at nominal line	Maximum power at nominal line
voltage:	voltage:
Idle: 35 VA	Idle: 35 VA
Seal: 400 VA	Seal: 400 VA
Full regulation range: 90 to 130 Vac	Full regulation range: 180 to 240 Vac
Operating Range: 100 to 120 Vac	Operating Range: 210 to 240 Vac
Mains current maximum:	Mains current maximum:
Idle: 389 mArms	Idle: 194 mArms
Seal: 4.44 Arms	Seal: 2.22 Arms
Mains line frequency range (nominal)	Mains line frequency range (nominal)
50 to 60 Hz	50 to 60 Hz
Fuses (2) – 5 mm x 20 mm 8 A, 250 V	Fuses (2) – 5 mm x 20 mm 8 A, 250 V
fast blow, high breaking capacity	fast blow, High breaking capacity
Power plug:	Power plug:
3-prong hospital-grade connector	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:

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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.

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.

Specifications Technical

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.

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2-7

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.

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Symbols

Catalogue number

Consult instructions for use

Manufacturer

Authorized representative in the European community

Date of manufacture

Footswitch

Alternating current

Potential equalization conductor terminal

Symbols

Specifications Technical

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual

2-9

Symbols

149°F

65°C

-22°F -30°C

Temperature limit

85%

25%

Humidity limitation

ME20

0123

2-10

Serial number

Not made with natural rubber latex

Temperature limitations

Humidity limitations

For sale by prescription only

Russian GOST-R

CE mark and notified body number

Volume adjustment for activation tones

Equipment should not be disposed in trash. Dispose of this product according to local regulation.

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual

Class I Equipment (IEC 60601-1)

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 60601- 1:2005 specifications for “defibrillator proof” designation and IEC 60601-2-2:2006 and IEC 60601-2-2:2009.

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 60601- 1:1988 + A1:1991 + A2:1995 clause 49, IEC 60601-1:2005 clause 11.8, IEC 60601-2- 2:2006 clause 51.101, and IEC 60601-2-2:2009 clause 201.11.8)

Electromagnetic Compatibility (IEC 60601-1-2 and

IEC 60601-2-2)

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.

Specifications Technical

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Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)

Notice

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 61000- 4-8)

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:

1.This device may not cause harmful interference.

2.This device must accept any interference received, including interference that may cause undesired operation.

Attention that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Note: This product has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This product generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause

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Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)

harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.

Warning

RFID function may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements (required by clause 5.2.2.5 b in IEC 60601-1-2:2007.

Guidance and manufacturer's declaration - electromagnetic emissions

The Valleylab Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the system should ensure that it is used in such an environment.

Emissions test	Compliance	Electromagnetic
		environment - guidance
RF emissions	Group 1	The Valleylab Single Channel
CISPR 11		Vessel Sealing Generator must
		emit electromagnetic energy
		in order to perform its
		intended function. Nearby
		electronic equipment may be
		affected.

RF emissions	Class A
CISPR 11
Harmonic emissions	Class A
IEC 61000-3-2
Voltage fluctuations/flicker	Complies
emissions IEC61000-3-3

The Valleylab Single Channel Vessel Sealing Generator is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Specifications Technical

The essential performance requirement per IEC 60601-1 does not apply to the generator. Basic Safety is the performance requirement used during immunity testing.

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Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)

Guidance and manufacturer's declaration - electromagnetic immunity

The generator is intended for use in the electromagnetic environment specified below. The customer or the user of the system should ensure that it is used in such an environment.

	Immunity test	IEC 60601 test	Compliance level	Electromagnetic
		level		environment - guidance
	Electrostatic	+/-6 kV contact	+/-6 kV contact	Floors should be wood,
	discharge (ESD)	+/-8 kV air	+/-8 kV air	concrete or ceramic tile. If
	IEC 61000-4-2			floors are covered with
				synthetic material, the
				relative humidity should be at
				least 30%.
	Electrical fast	+/-2 kV for	+/-2 kV for power	Mains power quality should
	transient/burst	power supply	supply lines	be that of a typical
	IEC 61000-4-4	lines	+/-1 kV for input/	commercial or hospital
				environment.
		+/-1 kV for	output lines
		input/output
		lines
	Surge	+/-1 kV	+/-1 kV differential	Mains power quality should
	IEC 61000-4-5	differential	mode	be that of a typical
		mode	+/-2 kV common	commercial or hospital
				environment.
		+/-2 kV common	mode
		mode
	Voltage dips, short	<5% UT (>95%	<5% UT	Mains power quality should
	interruptions and	dip in UT)	(>95% dip in UT)	be that of a typical
	voltage variations	for 0,5 cycle	for 0,5 cycle	commercial or hospital
	on power supply	40% UT	40% UT	environment. If the user of
	input lines			the generator requires
		(>60%dipinUT)	(>60% dip in UT)
	IEC 61000-4-11			continued operation during
		for 5 cycles	for 5 cycles
				power mains interruptions, it
		70% UT	70% UT
				is recommended that the
		(>30%dipinUT)	(>30% dip in UT)	system be powered from an
		for 25 cycles	for 25 cycles	uninterruptible power supply
		<5% UT	<5%UT	or a battery.
		(>95%dipinUT)	(>95% dip in UT)
		for 5 sec	for 5 sec
	Power frequency	3 A/m	3 A/m	Power frequency magnetic
	(50/60 Hz)			fields should be at levels
	magnetic field			characteristic of a typical
	IEC 61000-4-8			location in a typical
				commercial or hospital
				environment.

NOTE: UT is the a.c. mains voltage prior to the application of the test level.

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