LS10 Users Guide

Preface

Preface This guide and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for using the Covidien Valleylab LS10, LS Series Single Channel Vessel Sealing Generator only. Additional technical information is available in the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual. Equipment covered in this manual Valleylab LS10, LS Series Single Channel Vessel Sealing Generator VLLS10GEN

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.

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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

Limited Warranty

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 LS10, LS Series Single Channel One year from date of shipment Vessel Sealing Generator All purchased or supplemental software programs or updates

90 days from delivery

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

Software License Covidien llc, (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, 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

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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

Software License

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

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Software License

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.

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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

Table of Contents Preface... ii Conventions Used in this Guide... ii Limited Warranty...iii Software License... iv

Chapter 1. Introduction Indications for Use... 1-2 Generator Front Panel... 1-3 Generator Back Panel... 1-4 LigaSure Mode... 1-5

Chapter 2. Patient and Operating Room Safety General... 2-2 Setting Up the System... 2-2 Fire/Explosion Hazard... 2-3 Implanted Electronic Devices (IEDs)... 2-4 Inadvertent Radio Frequency (RF) Burns... 2-5 LigaSure... 2-5 LigaSure in Minimally-invasive Procedures... 2-7 After Surgery... 2-8 Servicing... 2-8

Chapter 3. System Setup LigaSure Function Overview... 3-2 LigaSure Receptacle... 3-2 Footswitch... 3-3 Setup... 3-3 Before Startup... 3-3 Powering Up the Generator... 3-3 LigaSure Instruments... 3-4 Connecting LigaSure Instruments to the Generator... 3-4 Activating the LigaSure Instrument... 3-5 Alert Situations... 3-5 After Surgery... 3-6

Chapter 4. Troubleshooting General Troubleshooting Guidelines... 4-2 System Alerts and Troubleshooting... 4-2 Service Mode... 4-4 Correcting Malfunctions... 4-4

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Chapter 5. Maintenance and Repair Responsibility of the Manufacturer... 5-2 Routine Maintenance and Periodic Safety Checks... 5-2 Cleaning... 5-3 Product Service... 5-3 Returning the Generator for Service... 5-3 Adjustment to Factory Specification (Calibration)... 5-4 Software Updates... 5-4 Covidien Technical Service... 5-4

Chapter 6. Technical Specifications Performance Characteristics... 6-2 General... 6-2 Dimensions and Weight... 6-2 Operating Parameters... 6-3 Transport and Storage... 6-3 Duty Cycle... 6-3 Internal Battery... 6-3 Audio Volume... 6-4 Activation Tone... 6-4 Alert Tone... 6-4 USB Port... 6-5 Potential Equalization Conductor Terminal... 6-5 Radio Frequency Identification (RFID)... 6-5 Low Frequency (50/60 Hz) Leakage Current (IEC 60601-2-2)... 6-5 High Frequency (RF) Leakage Current (IEC 60601-2-2) . . . 6-6 Input Power... 6-6 Power Cord Specification... 6-7 Input Frequency... 6-7 Input Current... 6-7 Backup Power... 6-7 ECG Blanking... 6-7 Standards and IEC Classifications... 6-8 Symbols... 6-9 Class I Equipment (IEC 60601-1)... 6-11 Type CF Equipment (IEC 60601-1)/Defibrillator Proof . . . 6-11 Liquid Spillage (IEC 60601-2-2:2006 Clause 44.3 and IEC 60601-2-2:2009 Clause 201.11.6.3)... 6-11

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Voltage Transients (Emergency Generator Mains Transfer)... 6-11 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)... 6-12 Output Characteristics... 6-14 Maximum Output for LigaSure Mode... 6-14 Output Waveforms... 6-14 Output Power vs. Resistance Graphs... 6-15 LigaSure... 6-15 China RoHS Compliance (applies to China only)... 6-16

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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. 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. 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 LigaSure instruments are not included in this manual.

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

1-1

Indications for Use

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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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

Generator Front Panel

Introduction

Generator Front Panel 2

3

4

5

6

1

LigaSure

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 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.

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

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

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Generator Back Panel

Generator Back Panel 2

1

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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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

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

LigaSure Mode

Warning Do not attempt to fuse lung tissue with LigaSure mode or instruments without first consulting the respective instrument instructions for use for indicating such use.

LigaSure Instruments The LigaSure instruments that complete the Valleylab vessel sealing system include reusable and single-use instruments for open and minimally-invasive procedures. Each reusable instrument requires a corresponding single-use electrode. The LigaSure function is only available when using Covidien LigaSure instruments.

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Chapter 2 Patient and Operating Room Safety

The safe and effective use of vessel sealing technology in surgical procedures 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. 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 compared to the benefits of utilizing vessel sealing technology in the procedure.

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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. Do not connect wet instruments to the generator. Ensure that all instruments and adapters are correctly connected and that no metal is exposed at any connection points. Fire Hazard Do not use extension cords. Patient Safety Use the generator only if the power-up self-test has been completed as described in this manual, otherwise inaccurate power outputs may result. 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. Do not wrap the instrument cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team. Contact between the active electrode and any metal will greatly increase current flow and can result in unintended surgical effect. While using vessel sealing technology in surgical procedures, the patient should not be allowed to come into direct contact with grounded metal objects (e.g., surgical-table frame, instrument table, etc.). If this is not possible during certain procedures (e.g., those in which noninsulated head frames are used), use extreme caution to maximize patient safety: •

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.

Precaution Read all warnings, precautions, and instructions provided with this generator before using. Read the instructions, warnings, and precautions provided with LigaSure instruments before using. Specific instructions for LigaSure instruments are not included in this manual. Examine all instruments and connections to the system before using. Ensure that the LigaSure 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 generator is delivering RF energy.

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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

General

Precaution A non-functioning generator may cause interruption of surgery. A backup system should be available for use. Inadvertent activation may occur while installing or removing jaw electrode plates on compatible LigaSure Instruments. Ensure that the instrument cord is not connected to the generator or that the system is OFF. When using a smoke evacuator in conjunction with the generator, set the system volume control at a level that ensures that the activation tones can be heard.

Use caution if stacking equipment on top of the generator or placing the generator on top of electrical equipment. This is an unstable configuration and does not allow for adequate cooling. Provide as much distance as possible between the generator and other electronic equipment (such as monitors). Do not cross or bundle electronic-device cords. This generator may cause interference with other electronic equipment. Studies have shown that smoke generated during vessel sealing 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.1

Patient and Operating Room Safety

Connect only Covidien approved LS0300 footswitch (purple). Using footswitches from other manufacturers may cause equipment malfunction.

1. 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

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 generator to the hospital equalization connector with an equipotential cable.

Fire/Explosion Hazard Warning Explosion Hazard Do not use vessel sealing technology in the presence of flammable anesthetics. Fire Hazard Do not place LigaSure instruments near or in contact with flammable materials (such as gauze or surgical drapes). LigaSure instruments that are activated or hot from use can cause a fire. When not in use, place LigaSure instruments in a safety holster or safely away from patients, the surgical team, and flammable materials.

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

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General

Warning Fire Hazard Sparking and heating associated with vessel sealing technology can be an ignition source. Keep gauze and sponges wet. Keep electrosurgical electrodes away from flammable materials and oxygen (O2) enriched environments. Use of vessel sealing technology 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 vessel sealing technology. Do not activate the generator until flammable vapors from skin-preparation 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 LigaSure electrodes 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 vessel sealing technology. Fire Hazard During Oropharyngeal Surgery Verify endotracheal tubes are leak free and that the cuff seals properly to prevent oxygen leaks. If an uncuffed tube is in use, pack the throat with wet sponges around the uncuffed tube, and be sure to keep sponges wet throughout the procedure. Question the need for 100% O2 during oropharyngeal or head and neck surgery. If necessary, scavenge excess O2 with separate suction.

Implanted Electronic Devices (IEDs) IEDs include, but are not limited to, pacemakers, neurostimulators, implantable cardioverter defibrillators (ICDs), ventricular assist devices (VAD), spinal cord stimulators, cochlear implants, infusion pumps, and bone-growth stimulators. Warning Use vessel sealing technology with caution in the presence of internal or external pacemakers. Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the pacemaker manufacturer or hospital cardiology department for further information when use of vessel sealing technology is planned in patients with cardiac pacemakers.

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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

Inadvertent Radio Frequency (RF) Burns

Warning If the patient has an IED, contact the IED manufacturer for instructions before use. Vessel sealing technology may cause multiple activations of ICDs, or interfere with the intended function of other IEDs.

Inadvertent Radio Frequency (RF) Burns Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar equipment) can provide a path for high frequency current even if the electrodes or probes are isolated at 50 Hz-60 Hz, insulated, and/or battery operated. Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent electrosurgical burns may result.

LigaSure Warning

Patient and Operating Room Safety

Warning

LigaSure instruments are intended for use only with compatible Covidien generators and energy platforms. See the instrument instructions for use for a list of compatible generators.Use of these instruments with other generators may not result in electrical output for which these instruments were designed and may not result in the desired clinical effect. If the Seal Cycle Complete tone has not sounded, an optimal seal may not have been achieved. Reactivate the RF energy until a Seal Cycle Complete tone is heard. The LigaSure vessel sealing function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures. Use caution during surgical cases in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.). For best results, apply the seal to unaffected vasculature. Do not activate the generator in the LigaSure mode until the vessel sealing instrument has been applied with the proper pressure. Activating the generator before this is done will result in an improper seal and may increase thermal spread to tissue outside the surgical site. Vessel sealing requires the application of RF energy and pressure from the instrument. Tissue to be sealed must be firmly grasped between the instrument jaw electrodes. Tissue in the jaw hinge or outside the instrument jaw will not be sealed even if thermal blanching occurs. Do not use LigaSure instruments on vessels in excess of 7 mm in diameter. LigaSure instruments that require single-use electrodes must be used with the correct electrode type. Use of these instruments with any other electrodes could result in injury to the patient or surgical team, or cause damage to the instrument.

Valleylab LS10, LS Series Single Channel Vessel Sealing Generator

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LigaSure

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

Precaution Read the instructions, warnings, and precautions provided with LigaSure instruments before using. Specific instructions for LigaSure instruments are not included in this manual. Inspect instruments and cords for breaks, cracks, nicks, and other damage before every use. If damaged, do not use. Damaged instruments or cords may result in injury or electrical shock to the patient or surgical team. Use only instruments that can withstand the maximum output (peak) voltage for each output mode as listed in Chapter 6, Technical Specifications. Using an instrument with a voltage rating that is lower than the maximum output voltage may result in injury to the patient or the operator, or damage to the instrument. All compatible Covidien instruments have voltage ratings that are greater than the maximum output voltages in the generator. Position patient leads and instrument cords in such a way that contact with the patient or other leads or cords is avoided. Energy-based devices, such as electrosurgical pencils or ultrasonic scalpels, that are associated with thermal spread should not be used to transect seals.

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Valleylab LS10, LS Series Single Channel Vessel Sealing Generator