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User’s Guide
Valleylab
TM
LS10
LS Series Single Channel Vessel Sealing Generator
User’s Guide
Valleylab
TM
LS10
LS Series Single Channel Vessel Sealing Generator
For use with software version 1.1x
Part Number: PT00011382
ii Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
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 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.
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator iii
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:
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.
ValleylabTM
LS10, LS Series Single Channel
Vessel Sealing Generator
One year from date of shipment
All purchased or supplemental software
programs or updates
90 days from delivery
iv Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
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, non-
sublicensable, 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
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator v
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 non-
COVIDIEN 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
vi Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
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.
Table of Contents
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator vii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii
Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv
Chapter 1. Introduction
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Generator Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Generator Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
LigaSure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
LigaSure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Chapter 2. Patient and Operating Room Safety
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Setting Up the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Fire/Explosion Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Implanted Electronic Devices (IEDs) . . . . . . . . . . . . . . . . . . 2-5
Inadvertent Radio Frequency (RF) Burns . . . . . . . . . . . . . . . . . . 2-5
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
A power button to turn the system on and off. . . . . . . . . 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
viii Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Chapter 4. Troubleshooting
General Troubleshooting Guidelines . . . . . . . . . . . . . . . . . . . . . 4-2
System Alerts and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 4-2
Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Correcting Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
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) . . . . . . . . . . . . . . . . . . . . 6-12
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator ix
Type CF Equipment (IEC 60601-1)/Defibrillator Proof. . . 6-12
Liquid Spillage (IEC 60601-2-2:2006 Clause 44.3 and
IEC 60601-2-2:2009 Clause 201.11.6.3) . . . . . . . . . . . . . . . 6-12
Voltage Transients (Emergency Generator
Mains Transfer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Electromagnetic Compatibility (IEC 60601-1-2
and IEC 60601-2-2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Output Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Maximum Output for LigaSure Mode . . . . . . . . . . . . . . . 6-19
Output Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Output Power vs. Resistance Graphs. . . . . . . . . . . . . . . . . . . . . 6-20
LigaSure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
China RoHS Compliance (applies to China only) . . . . . . . . . . . 6-21
Chapter 1
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 1-1
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.
1-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
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.
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 1-3
Generator Front Panel
Introduction
Generator Front Panel
཰ 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 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.
ཱི 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.
LigaSure
1
2 3 4
6
5
1-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Generator Back Panel
Generator Back Panel
཰ Volume knob
ཱ Footswitch port
ི Serial label
ཱི Potential equalization conductor terminal
ུ AC Fuse
ཱུ AC mains receptacle
ྲྀ ECG blanking connector
ཷ USB port
ླྀ Vent
1
9 8
5
2 3 4
6
7
Warning: Risk of Fire.
Replace Fuse as Marked.
250V, F8.0A (100-240)
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 1-5
LigaSure Mode
Introduction
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.
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.
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.
Chapter 2
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-1
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.
2-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
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.
• In all cases, monitoring systems incorporating high frequency current limiting devices are
recommended.
A failure of the LS10 could result in an unintended increase of output power.
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.
Patient
and
Operating
Room
Safety
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-3
General
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.
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.
Connect only Covidien approved LS0300 footswitch (purple). Using footswitches from other
manufacturers may cause equipment malfunction.
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
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.
Precaution
2-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
General
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.
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.
Patient
and
Operating
Room
Safety
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-5
Inadvertent Radio Frequency (RF) Burns
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.
Inadvertent Radio Frequency (RF) Burns
LigaSure
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.
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.
Warning
Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar
equipment) can provide a path for high frequency current even if the electrodes or probes are
isolated at 50 Hz-60 Hz, insulated, and/or battery operated.
Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent
electrosurgical burns may result.
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.
2-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
LigaSure
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.
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.
Warning
Patient
and
Operating
Room
Safety
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-7
LigaSure
LigaSure in Minimally-invasive Procedures
Warning
For laparoscopic procedures, be alert to these potential hazards:
• Laparoscopic surgery may result in gas embolism due to insufflation of gas in the abdomen.
• The jaw electrode may remain hot enough to cause burns after the electrosurgical current is
deactivated.
• Localized burns to the patient or physician may result from electrical currents carried through
conductive objects (such as cannulas or scopes). Electrical current may be generated in
conductive objects through direct contact with the active electrode, or by the LigaSure
instrument (electrode or cable) being in close proximity to the conductive object.
• Do not use hybrid trocars that have a non-conductive locking anchor placed over a conductive
sleeve. For the operative channel, use all-metal or all-plastic systems. At no time should
electrical energy pass through hybrid systems. Capacitive coupling of RF current may cause
unintended burns.
• When using laparoscopic instrumentation with metal cannulas, the potential exists for
abdominal-wall burns to occur due to direct electrode contact or capacitive coupling of RF
current. This is most likely to occur in instances where the generator is activated for extended
periods at high power levels inducing high-current levels in the cannula.
• Ensure that the insulation of single-use and reusable laparoscopic instrumentation is intact and
uncompromised. Compromised insulation may lead to inadvertent metal-to-metal sparking
and neuromuscular stimulation and/or inadvertent sparking to adjacent tissue.
Covidien recommends against the use of laparoscopic surgery on pregnant patients.
Warning
For laparoscopic procedures, be alert to these potential hazards:
• The external surfaces of the LigaSure instrument jaws may remain hot enough to cause burns
after the RF current is deactivated.
• Inadvertent activation or movement of the activated LigaSure instrument outside of the field
of vision may result in injury to the patient.
• Do not activate the instrument while the instrument jaws are in contact with, or in close
proximity to, other instruments including metal cannulas, as localized burns to the patient or
physician may occur.
• Do not activate the LigaSure function in an open-circuit condition. Activate the generator only
when the instrument is near or in direct contact with the target tissue to reduce the possibility
of unintended burns.
• Carefully insert and withdraw LigaSure instruments from cannulas to avoid possible damage to
the devices and/or injury to the patient.
2-8 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Servicing
After Surgery
Servicing
Warning
Electric Shock Hazard Always turn off and unplug the generator before cleaning.
Precaution
Do not reprocess, reuse, or resterilize instruments labeled “disposable” or “single use only.”
Notice
Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the generator.
Warning
Electric Shock Hazard Do not remove the generator cover. Contact qualified personnel for
service.
Notice
Refer to this system’s service manual for maintenance recommendations, and function and output-
power verification procedures.
The generator remains connected to mains after shut down by the front panel button. To
completely disconnect the generator from mains, detach the power cord from either the wall
socket or the appliance connector on the rear panel. Position the generator so it doesn’t block
access to the power cord for disconnection.
Chapter 3
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 3-1
System Setup
This chapter describes how to set up the Valleylab LS10, LS Series Single Channel
Vessel Sealing Generator, turn it on, and configure system settings.
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.
3-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
LigaSure Function Overview
LigaSure Function Overview
The LigaSure vessel sealing mode can be used on arteries, veins, and lymphatics up to and
including 7 mm (0.275 inches) in diameter and tissue bundles. This system provides precise
energy delivery and electrode pressure to tissues for a controlled period to achieve a
complete and permanent fusion of tissues and vessel lumens. The system is designed to
produce minimal sticking, charring, and thermal spread to adjacent tissue.
The front panel of the generator is divided into 5 functional parts:
1. A power button to turn the system on and off.
2. A system error indicator.
3. A system status indicator that consists of a circle of lights located in the center of the
front panel to indicate different system states.
4. An instrument status or switch stuck indicator.
5. One instrument receptacle.
Note: Only one LigaSure instrument can be set up at one time. The generator supports a
single LigaSure instrument.
LigaSure Receptacle
The LigaSure receptacle is located on the right side of the front panel labeled with
LigaSure. The generator will automatically identify compatible instruments.
Refer to the instrument labeling to confirm the compatibility of a specific LigaSure
instrument with this generator.
Warning
Electric Shock Hazard
• Do not connect wet instruments to the generator.
• Ensure that all instruments are correctly connected and that no metal is exposed at any
connection point.
Connect compatible instruments to the receptacle properly. Improper connection may result in an
inadvertent instrument activation or other potentially hazardous conditions. Follow the instructions
provided with LigaSure instruments for proper connection and use.
The instrument receptacle on this system is designed to accept only one instrument at a time. The
system is a single channel LigaSure generator.
Precaution
Read the instructions, warnings, and precautions provided with LigaSure instruments before use.
Specific instructions are not included in this manual.
System
Setup
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 3-3
Setup
Footswitch
The generator is compatible with LigaSure footswitch LS0300 (purple).
To activate LigaSure instrument with footswitch, attach a LigaSure footswitch LS0300
(purple) to the footswitch port on the rear panel.
The LigaSure instrument with in-line activation functionality does not support footswitch
activation.
Setup
Before Startup
1. Place the generator on a flat, stable surface such as a table, platform, boom system,
or cart. Refer to the procedures for your local institution or your local codes.
2. Plug the system power cord into the rear-panel AC mains receptacle.
3. Plug the system power cord into a grounded power outlet.
Note: Do not plug into a power strip or extension cord.
Note: The generator must be set up using the Valleylab Exchange Remote Software
System. For instructions, refer to the First Time Setup Guide or the Valleylab Exchange
Remote Software System User’s Guide. The First Time Setup Guide and Valleylab
Exchange Remote Software System User’s Guide are available online at
www.covidien.com/valleylabexchange.
Powering Up the Generator
1. Turn on the system by pressing the power on/off button. Observe the following during
the power-up self-test:
• System status indicator illuminates white, rotating segment by segment, indicating
boot and self-test activity.
• A tone sounds upon completion of self-test and system indicator illuminates
constant white.
2. If the system does not pass the power-up self-test and an error indicator is displayed,
refer to Chapter 4, System Alerts and Troubleshooting section for troubleshooting
instructions.
Inspect instruments and cords (especially reusable instruments and cords) for breaks, cracks, nicks,
and other damage before every use. If damaged, do not use. Failure to observe this precaution may
result in injury or electrical shock to the patient or surgical team.
Precaution
3-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
LigaSure Instruments
LigaSure Instruments
Connecting LigaSure Instruments to the Generator
Insert a LigaSure connector (1) into the receptacle on the front panel of the generator.
• Valid Instrument - If the generator is compatible with the LigaSure instrument, the
system status indicator illuminates purple, indicating the system is ready for surgical
use.
• Invalid instrument - If the generator does not recognize the attached instrument, the
light above the receptacle illuminates with a red light for an invalid instrument. Refer
to the following steps to resolve the issue.
– Confirm the instrument is fully inserted by reconnecting the instrument using firm
pressure to insert the instrument into the instrument receptacle.
– If the red light above the receptacle continues to appear, use a new, compatible
LigaSure instrument.
There are several reasons an instrument can be read as invalid, including:
• Not recognized
• Not compatible
• Handswitch or footswitch is stuck
1
System
Setup
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 3-5
LigaSure Instruments
Activating the LigaSure Instrument
1. Activate the LigaSure instrument either by pressing and holding the activation button
on the instrument or by stepping on and holding the footswitch pedal. For the
duration of energy delivery, the system status indicator illuminates purple, rotating
segment by segment, and an activation tone sounds.
2. When the two-pulse seal cycle complete tone is emitted and the system status
indicator illuminates solid purple indicating completed seal cycle, release the activation
button or footswitch. In the case of an alert condition, refer to the following section.
Alert Situations
A four-pulse tone will sound when any incomplete seal cycle condition occurs and the
center circle on the front panel will illuminate with a solid amber light. When an alert
condition occurs, energy delivery will be interrupted.
Check Instrument and Reactivate
If the incomplete seal cycle is indicated, the user should:
1. Release the footswitch pedal or activation button on the instrument.
2. Open the instrument jaws and inspect for a successful seal.
3. Follow the suggested corrective action.
• Regrasp thicker tissue - The user is grasping this tissue or not enough tissue; open
the jaws and confirm that a sufficient amount of tissue is inside the jaws. If
necessary, increase the amount of tissue and reactivate the seal cycle.
• Reinsert electrodes - Electrodes may have become dislodged from the instrument.
• Check for clips/regrasp tissue - Avoid grasping objects such as staples, clips, or
encapsulated sutures in the jaws of the instrument.
• Clean electrode tips - Use a wet gauze pad to clean surfaces and edges of the
instrument jaws.
• Remove excess fluids - Minimize or remove excess fluids from around the
instrument jaws.
4. Hold the handswitch or footswitch until the seal cycle complete tone is heard.
5. If possible, reposition the instrument and regrasp tissue in another location. Reactivate
the seal cycle.
3-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
LigaSure Instruments
After Surgery
1. Turn off the generator by pressing and holding the power on/off button for three
seconds.
2. Disconnect all instruments from the front panel.
• If the instrument is a single use only (disposable), dispose of it according to the
procedures for your institution.
• If the instrument is reusable, clean and sterilize it according to the manufacturer’s
instructions for use.
3. Disconnect and store footswitch.
Chapter 4
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-1
Troubleshooting
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.
4-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
General Troubleshooting Guidelines
General Troubleshooting Guidelines
If the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator malfunctions,
check for obvious conditions that may have caused the problem:
• Perform steps outlined in Chapter 4, System Alerts and Troubleshooting section for the
specific issue.
• Check the system for visible signs of physical damage.
• Make sure the fuse drawer is tightly closed.
• Verify that all cords are connected and attached properly.
• If the problem is still unclear, turn the generator off, then turn it back on.
If the malfunction persists, the system may require service. Contact your institution’s
biomedical engineering department or Covidien Technical Service as indicated on page 5-
4.
System Alerts and Troubleshooting
Most system alerts require actions on your part to correct the condition; however, some
are corrected automatically. Use the following list to determine how to correct an alert
condition. After correcting the alert condition, power cycle the generator, confirm the self-
test completes, and returns to ready state as described in Chapter 3, System Setup.
Indicators Description Actions
Amber color system status
indicator and four-pulse
tone delivered
Seal cycle incomplete Refer to Chapter 3, Check Instrument
and Reactivate section
Troubleshooting
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-3
General Troubleshooting Guidelines
Red instrument status
indicator and three-pulse
tone delivered
Invalid instrument or
stuck handswitch or
footswitch
Check the handswitch and make sure
it is released. If the problem remains,
remove the instrument and observe
the instrument status indicator.
1) If it remains red, the footswitch is
depressed. Check the footswitch.
2) If it turns off, the LigaSure
handswitch is stuck or an invalid
instrument is inserted. Replace
with a new LigaSure instrument.
Red system error indicator
illuminated and three-
pulse tone delivered
System error Power cycle the generator. If error
recurs, system fault is present.
Contact Covidien Technical Service as
indicated on page 5-4.
No audio tone upon
attempted activation of
footswitch
Footswitch fault may be
present
Confirm instrument is fully inserted in
receptacle by removing and
reinserting LigaSure connector.
Confirm the footswitch plug is fully
inserted by reconnecting the plug to
ensure pin alignment.
Single pulse tone
delivered when
footswitch pressed, no
energy delivered
Footswitch activation
disabled for connected
LigaSure instrument
Replace instrument with a footswitch-
compatible LigaSure instrument or
use handswitch functionality to
activate energy.
Amber or red usage limit
indicator illuminated
Inserted device has
already been used
Replace with certified Covidien
LigaSure instrument.
Indicators Description Actions
4-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Correcting Malfunctions
Service Mode
Service mode functionality requires an external PC and manual command entry. See
service manual for details. When the system is in service mode, the system status indicator
will illuminate white and flash. Cycle power to exit service mode.
Correcting Malfunctions
If a solution is not readily apparent, use the table below to help identify and correct specific
malfunctions. After you correct the malfunction, power cycle the generator, confirm the
self-test completes, and returns to ready state as described in Chapter 3, System Setup.
White color system status
indicator illuminated and
flashing
System in service mode Cycle the power to exit service mode.
Situation Possible Cause Solution
Abnormal neuromuscular
stimulation (stop surgery
immediately)
Metal-to-metal sparking Check all connections to the
generator and LigaSure
instrument and cords for
damage.
Abnormal 50 Hz-60 Hz
leakage currents
Contact your biomedical
engineering department or a
Covidien Technical Service
representative for assistance.
Indicators Description Actions
Troubleshooting
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-5
Correcting Malfunctions
Generator does not respond
when turned on
Disconnected power cord or
faulty wall outlet
Check power cord connections
(generator and wall outlet).
Connect the power cord to a
functional outlet.
Faulty power cord Replace the power cord.
Fuse drawer is open or fuses
are blown.
Replace the blown fuse(s).
Close the fuse drawer. Refer to
the service manual.
Internal component
malfunction
Use a backup generator.
Contact your biomedical
engineering department or a
Covidien Technical Service
representative for assistance.
System is on, but did not
complete the self-test;
system status indicator does
not achieve system ready for
use status (constant white)
Software malfunction Turn off, then turn on the
generator.
Internal component
malfunction
Use a backup generator.
Contact your biomedical
engineering department or a
Covidien Technical Service
representative for assistance.
Generator is on and
instrument is activated, but
system does not deliver
energy
Malfunctioning footswitch or
handswitching instrument
Check and reconnect
instrument and/or footswitch
connection.
Power cycle the generator.
Replace the instrument if it
continues to malfunction.
Internal component
malfunction
Use a backup generator.
Contact your biomedical
engineering department or a
Covidien Technical Service
representative for assistance.
Situation Possible Cause Solution
4-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Correcting Malfunctions
Incomplete seal cycle
alert front panel will
illuminate with a solid
amber light, a four-pulse
tone sounds, and RF output
is disabled
Excessive tissue/eschar on jaws Clean jaws with a wet gauze
pad.
Electrodes have come loose
from the instrument jaws
Electrode pins may have been
compromised or bent during
assembly of the instrument
and may need to be replaced
Re-insert the electrode into the
instrument jaws making sure
that all the electrode pins are
firmly seated. If not resolved,
replace the LigaSure
instrument.
Metal or other foreign object is
grasped within jaws
Avoid grasping objects, such as
staples, clips, or encapsulated
sutures in the jaws of the
instrument.
Tissue grasped within jaws is
too thin
Open the jaws and confirm
that a sufficient amount of
tissue is inside the jaws. If
necessary, increase the
amount of tissue and repeat
the procedure.
Pooled fluids around
instrument tip
Minimize or remove excess
fluids.
The seal cycle was interrupted
before completion. The
handswitch or footswitch was
released before the end tone
activated.
Additional time and energy are
needed to complete the seal
cycle
Reactivate the seal cycle
without removing or
repositioning the instrument.
Continuous patient or video
monitor interference
Faulty power cord or display
cables
Check and replace power cord
and display cables for the
monitor and power cord for
the generator.
Electrical equipment is
grounded to different objects
rather than a common ground.
The generator may respond to
the resulting voltage
differences between grounded
objects.
Plug all electrical equipment
into line power at the same
location. Contact your
biomedical engineering
department or a Covidien
Technical Service
representative for assistance.
Malfunctioning monitor Replace the monitor.
Situation Possible Cause Solution
Troubleshooting
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-7
Correcting Malfunctions
Interference with other
devices only when the
generator is activated
Metal-to-metal sparking Check all connections to the
generator and LigaSure
instrument and cords for
damage.
Electrically inconsistent ground
wires in the operating room
Verify that all ground wires are
as short as possible and go to
the same grounded metal.
If interference continues when
the generator is activated, the
monitor is responding to
radiated frequencies.
Ask your biomedical
engineering department to
check with the manufacturer
of the monitor.
Some manufacturers offer RF
choke filters for use in monitor
leads. The filters reduce
interference when the
generator is activated.
Pacemaker interference Intermittent connections or
metal-to-metal sparking
Check the active electrode
cord connections.
It may be necessary to
reprogram the pacemaker.
Always monitor patients with
pacemakers during surgery
and keep a defibrillator
available.
Consult the pacemaker
manufacturer or hospital
cardiology department for
further information when use
of the LigaSure system is
planned in patients with
cardiac pacemakers.
Internal Cardiac Defibrillator
(ICD) activation
ICD is activated by generator Stop the procedure and
contact the ICD manufacturer
for instructions.
Situation Possible Cause Solution
Chapter 5
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 5-1
Maintenance and Repair
This chapter presents the following information:
• The manufacturer’s responsibility
• Routine maintenance
• Returning the generator for service
• Service centers
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.
5-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Responsibility of the Manufacturer
Responsibility of the Manufacturer
Covidien is responsible for the safety, reliability, and performance of the generator only if
all of the following conditions have been met:
• Installation and setup procedures in this manual are followed.
• Assembly, operation, readjustments, modifications, or repairs are carried out by
persons authorized by Covidien.
• The electrical installation of the relevant room complies with local codes and regulatory
requirements, such as IEC, UL or CSA.
• The equipment is used in accordance with the Covidien instructions for use.
• Covidien recommends disposal of this equipment according to the local regulation.
For warranty information, refer to the Limited Warranty section in this manual.
Routine Maintenance and Periodic Safety Checks
When should the generator be checked or serviced?
Covidien recommends that the generator be inspected by qualified service personnel prior
to being placed into service and at least once a year. This inspection should include
adjusting the system to factory specifications.
When should the power cord be checked or replaced?
Check the power cord before each use of the system or at the intervals recommended by
your institution. Check the power cord for exposed wires, cracks, frayed edges, or a
damaged connector. Replace damaged cords.
When should the fuses be replaced?
An internal component malfunction can damage the fuses. The system fuses may need to
be replaced if the system fails the self-test or if the system stops functioning, even though
it is receiving power from a wall outlet. Refer to the Valleylab LS10, LS Series Single
Channel Vessel Sealing Generator Service Manual for instructions.
Notice
Refer to the generator service manual for maintenance recommendations and function and output
power verification procedures.
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 5-3
Cleaning
Maintenance
and
Repair
Cleaning
1. Turn off the system and unplug the power cord from the wall outlet.
2. Thoroughly wipe all surfaces of the generator and power cord with a damp cloth and
mild cleaning solution or disinfectant. The generator will withstand the effects of
cleaning over time without degrading the enclosure or display quality.
Product Service
Covidien recommends that all Valleylab systems be returned to the manufacturer for all
service requirements. If any service is required without returning the system to the
manufacturer, Covidien recommends that only qualified personnel service the Valleylab
system.
Covidien defines qualified personnel as a person with electrosurgical equipment repair
experience, such as biomedical personnel, and/or individuals who have taken official
Covidien training courses.
Returning the Generator for Service
Before returning the generator, call a Covidien sales representative for assistance. If you
are instructed to send the generator to Covidien, do the following:
1. Obtain a return authorization number.
Call the Covidien Technical Service Center (see page 5-4) to obtain a Return
Authorization Number. Have the following information ready before the call:
• Hospital/clinic name/customer number
• Telephone number
• Department/address, city, state, and zip code
• Model number
• Serial number
• Description of the problem
• Type of repair to be done
Warning
Electric Shock Hazard Always turn off and unplug the generator before cleaning.
Notice
Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the generator.
5-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Adjustment to Factory Specification (Calibration)
2. Clean generator.
See the previous section, Cleaning.
3. Ship the generator.
a. Attach a tag to the generator that includes the return authorization number and
the information (hospital, phone number, etc.) listed in step 1.
b. Be sure the generator is completely dry before packing it for shipment. Package it
in its original shipping container, if available.
c. Ship the generator, prepaid, to the Covidien Service Center.
Adjustment to Factory Specification (Calibration)
Covidien recommends that only qualified personnel calibrate the generator. The generator
incorporates automatic calibration where possible to reduce the required equipment and
manual steps.
Software Updates
Software updates are available directly from Covidien by using the Valleylab Exchange
Remote Software System application. Go to www.covidien.com/valleylabexchange to
download and install the latest version of the Valleylab Exchange application. For
additional information, the Valleylab Exchange Remote Software System User’s Guide is
available on the Valleylab Exchange website.
Covidien Technical Service
For service, contact Covidien Technical Service or your Covidien sales representative.
Contact a Covidien Technical Service representative by telephone, email, or through the
Internet:
• USA and Canada: 1-800-255-8522 Option 2
• International: 1-303-476-7996
• Email: valleylab.technicalservice@covidien.com
• International service centers: www.surgical.com/international-service-centers
Chapter 6
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-1
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 LigaSure instruments before use.
Specific instructions for LigaSure instruments are not included in this manual.
6-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Performance Characteristics
Performance Characteristics
General
Dimensions and Weight
Output configuration Isolated output
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
Width 300 mm (11.81 inches)
Depth 377 mm (14.84 inches)
Height 105 mm (4.13 inches)
Weight 5 Kg (11 lbs)
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-3
Performance Characteristics
Operating Parameters
Transport and Storage
Duty Cycle
Under maximum-output settings and rated-load conditions (30 ohm load), the generator
is suitable for activation times of 5 seconds on, 15 seconds off, for 1 hour. With lesser
settings and loads, you can activate the generator for greater durations without
generating excessive internal temperatures.
Internal Battery
Ambient temperature
range
+10° C to +40° C (50° F to 104° F)
Relative humidity 30% to 75% non-condensing
Atmospheric pressure 700 to 1060 millibars
Warm-up time If transported or stored at temperatures outside
the operating temperature range, allow one hour
for the generator to reach room temperature
before use.
Ambient temperature
range
-30° C to 65° C (-22° F to 149° F)
Relative humidity 25% to 85% (non-condensing)
Atmospheric pressure 500 to 1060 millibars
Duration of storage If stored over one year, see service manual for
instructions or contact Covidien Service for further
information.
Battery for RTC Battery type – 3 V lithium button cell
Battery life – 5 years
6-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Performance Characteristics
Audio Volume
The stated audio levels are at a distance of one meter. Alert tones meet the requirements
of IEC60601-2-2.
Activation Tone
The audio levels stated below are for activation tones and alert tones at a distance of one
meter.
Alert Tone
Volume (adjustable) 45 dBa minimum
Frequency (nominal) Sealing in process – 440 Hz
Duration Continuous while the system is activated
Volume (not
adjustable)
65 dBa minimum
Frequency Seal cycle incomplete alert – High = 784 Hz, Low = 587
Hz
Seal cycle complete tone – 985 Hz
System error tone – 1421 Hz
Duration 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
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-5
Performance Characteristics
USB Port
The software provides an asynchronous serial-communications interface for
communicating with an externally-connected device.
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.
Potential Equalization Conductor Terminal
A potential equalization conductor terminal is provided to allow connection of the
generator to the ground.
Radio Frequency Identification (RFID)
The RFID module is located above the LigaSure port. The intended use of the RFID module
is to identify the inserted LigaSure instrument and configure the generator with the data
included in the RFID tag.
Frequency Range: 13.56 MHz
RF Output Power: 68.17 dBuV/m @ 3 meters
Type of Antenna: Integral Loop Antenna
Modulation: Amplitude-shift Keying (ASK)
Mode of Operation (Simplex/Duplex): Duplex
Contains Transmitter Module FCC ID: 2AAVI-JDK1901
Contains IC ID: 11355A-JDK1901
Low Frequency (50/60 Hz) Leakage Current
(IEC 60601-2-2)
Enclosure source
current, ground open
< 300 μA
Sourcecurrent,patient
leads, all outputs
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
Sink current at high
line, all inputs
< 50 μA
6-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Performance Characteristics
High Frequency (RF) Leakage Current (IEC 60601-2-2)
Input Power
Measured with leads
recommended by Covidien
Measured directly at the
system terminals
LigaSure
leakage
<116 mA RMS < 100 mA RMS
120 Volt 240 Volt
Maximum power at nominal line
voltage:
Idle: 35 VA
Maximum power at nominal line
voltage:
Idle: 35 VA
Seal: 400 VA Seal: 400 VA
Full regulation range:
90 to 130 Vac
Full Regulation Range:
180 to 264 Vac
Operating Range: 100 to 120 Vac
1) Mains current maximum:
2) Idle: 389 mArms
3) Seal: 4.44 Arms
Operating Range: 210 to 240 Vac
1) Mains current maximum:
2) Idle: 194 mArms
3) Seal: 2.22 Arms
Mains line frequency range (nominal):
50 to 60 Hz
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
Fuses (2) – 5 mm x 20 mm 8 A, 250 V
fast blow, high-breaking capacity
Power plug:
3-prong hospital grade connector
Power plug:
3-prong locally approved connector
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-7
Performance Characteristics
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:
• 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
• 220-240 VAC
Cable - H05VVF3G1.0 VDE, maximum length 15 ft. (5 m)
Plug - minimum 5 A - 250 VAC
Unit receptacle - IEC female, minimum 5 A - 250 VAC
Input Frequency
The generator operates within specification at all line-input frequencies between 48 Hz
and 62 Hz. The user does not need to reconfigure the generator 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 generator 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 to external devices that the generator is
delivering RF energy. Open the door to the USB/ECG blanking port cover to access the ECG
blanking port. 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 rated current and voltage rating of the ECG port is 0.2A at 12VDC.
Important
Contact your local Covidien representative for alternative internationally approved power-cord
options.
6-8 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Standards and IEC Classifications
Standards and IEC Classifications
The generator meets all pertinent clauses of the IEC 60601-1 and IEC 60601-2-2.
The generator 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.
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-9
Symbols
Symbols
Catalogue number
Consult instructions for use
Manufacturer
Authorized representative in the European community
Date of manufacture
Footswitch
Alternating current
Potential equalization conductor terminal
6-10 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Symbols
Serial number
Not made with natural rubber latex
Temperature limitations
Humidity limitations
For sale by prescription only
Eurasian conformity mark
Russian GOST-R
CE mark and notified body number
-22°F
-30°C
149°F
65°C
Temperature
limit
Humidity
limitation
25%
85%
ME20
0086
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-11
Symbols
Volume adjustment for activation tones
Equipment should not be disposed in trash. Dispose of this
product according to local regulation.
6-12 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Symbols
Class I Equipment (IEC 60601-1)
Accessible conductive parts cannot become live in the event of a basic insulation failure
because of 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 the 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 Generator
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)
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-13
Symbols
Electromagnetic Compatibility (IEC 60601-1-2
and IEC 60601-2-2)
The generator complies with the appropriate IEC 60601-1-2 and IEC 60601-2-2
specifications regarding electromagnetic compatibility.
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)
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. For more information, see
Chapter 3, Check Instrument and Reactivate section.
6-14 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Symbols
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 modification 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 CISPR 11
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 equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications. Operation of this
equipment in a residential is likely to cause harmful interference in which case the user will
be required to correct the interference at his own expense:
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).
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-15
Symbols
The essential performance requirement per IEC 60601-1 does not apply to the generator.
Basic Safety is the performance requirement used during immunity testing.
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 assure that it is used in such an environment.
Emissions test Compliance Electromagnetic
environment - guidance
RF emissions
CISPR 11
Group 1 The Valleylab Single Channel
Vessel Sealing Generator must
emit electromagnetic energy
in order to perform its
intended function. Nearby
electronic equipment may be
affected.
The Valleylab Single Channel
Vessel Sealing Generator is a
group 2 equipment.
According to IEC 60601-2-
2:2009 clause 202.6.1.1.1 bb)
it is tested in idle mode using
CISSPR 11 group 1 limits.
RF emissions
CISPR 11
Class A The Valleylab Single Channel
Vessel Sealing Generator is
suitable for use in all
establishments other than
domestic and those directly
connected to the public low-
voltage power supply network
that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
6-16 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Symbols
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 assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic
environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge IEC
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
< 5% UT (> 95% dip
in UT) for 0.5 cycle
< 40% UT (> 60%
dip in UT) for 5 cycles
< 70% UT (> 30%
dip in UT) for 25
cycles
< 5% UT (> 95% dip
in UT) for 5 sec
0% UT for 1 cycle
< 5% UT (> 95% dip
in UT) for 0.5 cycle
< 40% UT (> 60%
dip in UT) for 5 cycles
< 70% UT (> 30%
dip in UT) for 25
cycles
< 5% UT (> 95% dip
in UT) for 5 sec
0% UT for 1 cycle
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
30 A/m 30 A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Continued
NOTE: UT is the a.c. mains voltage prior to the application of the test level.
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-17
Symbols
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 Valleylab LS10 LS Series Single Channel Vessel Sealing Generator
should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the generator, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
7 Vrms d=1.2P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
7 V/m d=1.2P 80 MHz to 800 MHz
d=2.3P 800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
surveya
, should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol.
Continued
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
6-18 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Symbols
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the generator is used exceeds the
applicable RF compliance level above, the generator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the generator.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communication
equipment and the Valleylab LS10 LS Series Single Channel Vessel Sealing Generator
The generator is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the system can help prevent
electromagnetic interferences by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the system as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d=0.5 x P
80 MHz to 800 MHz
d=0.5 x P
800 MHz to 2.5 GHz
d= P
0.01 0.05 0.05 0.1
0.1 0.16 0.16 0.32
1 0.5 0.5 1
10 1.6 1.6 3.2
100 5 5 10
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Guidance and manufacturer’s declaration - electromagnetic immunity
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-19
Output Characteristics
Output Characteristics
Maximum Output for LigaSure Mode
Power readouts agree with actual power into rated load to within 15% or 5 W, whichever
is greater.
Output Waveforms
LigaSure vessel sealing technology, an automatic adjustment, controls all modes. As tissue
resistance increases throughout the seal cycle, the generator modulates current and
voltage until tissue resistance meets seal complete requirements as needed by the tissue-
sensing technology.
Precaution
To avoid injury to the patient or surgical team, use only instruments rated for use at, or greater
than, the maximum peak voltages listed below. For example, bipolar instruments must have
voltage ratings of 250 V peak or greater, as shown in the “Open Circuit Peak Voltage (max)”
column.
Mode Open Circuit
PeakVoltage
(max)
Open Circuit
P–P Voltage
(max)
Rated
Load
(max)
Power
(max)
Output
Frequency
Current
R.M.S
(max)
LigaSure 250 V 500 V 30 Ω 270 W 400 kHz 5.5 A
6-20 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
Output Power vs. Resistance Graphs
Output Power vs. Resistance Graphs
LigaSure
Output power versus impedance for LigaSure power
཰ Output power (watts)
ཱ Load resistance (ohms)
Nominal power curve for an output power of 270 W at rated load with current/voltage
limits per the power curve table.
Power curve represents the operational envelope, which varies.
Power Curve Limits [W]
Load (ohms) nominal high low
5 106.6 137.5 81.7
10 185.6 227.9 142.2
20 250.5 301.0 197.7
30 261.8 314.2 209.2
50 245.3 294.9 187.6
200 88.7 111.8 66.1
500 38.0 49.0 28.2
1000 19.5 25.3 14.5
Technical
Specifications
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-21
China RoHS Compliance (applies to China only)
California Proposition 65 Statement
For information regarding California Proposition 65, please refer to
www.covidien.com/caprop65.
China RoHS Compliance (applies to China only)
Hazardous Substance Table
(Part Name) (Toxic and Hazardous Substances or Elements)
(Pb) (Hg) (Cd) (CR(VI)) (PBB) (PBDE)
㓴㻵ঠࡧ⭥
䐟ᶯਜ਼⭥⊐ǃ
Րᝏಘ
(Main PCBA
including battery
cell and sensors)
X O O O O O
LED ᱮ⽪
(LED Display)
O O O O O O
⭥Ⓚ⁑ඇ
(PSU)
X O O O O O
VIBE™*⁑ඇ
(VIBE Module)
X O O O O O
⭥Ⓚ㓯
(Power Cord)
O O O O O O
䠁኎䜘Ԧ
(Metal parts)
O O O O O O
ກᯉ䜘Ԧ
(Plastic parts)
O O O O O O
ₑ㜦䜘Ԧ
(Rubber parts)
O O O O O O
⭥㔶㓴Ԧਜ਼
仾ᡷ
(Cable
assembly
including fans)
O O O O O O
㍗പԦ
(Fasteners)
O O O O O O
⌑ỹ䜘Ԧ
(Foam parts)
O O O O O O
6-22 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator
China RoHS Compliance (applies to China only)
O: 㺘⽪䈕ᴹ∂ᴹᇣ⢙䍘൘䈕䜘Ԧᡰᴹ൷䍘ᶀᯉѝⲴਜ਼䟿 , ᤹➗㓴ᡀঅ‫ݳ‬ EIP-AˈEIP-BˈEIP-C Ⲵ࠶
㊫ , ൷൘ SJ/T 11363-2006 㿴ᇊⲴ䲀䟿㾱≲ԕлDŽ
O: indicates that the content of the toxic and hazardous substance in all the Homogenous
Materials of the part, according to EIP-A, EIP-B, EIP-C, is below the concentration limit
requirement as described in SJ/T 11363-2006.
X: 㺘⽪䈕ᴹ∂ᴹᇣ⢙䍘㠣ቁ൘䈕䜘ԦⲴḀа൷䍘ᶀᯉѝⲴਜ਼䟿 , ᤹➗㓴ᡀঅ‫ݳ‬ EIP-AˈEIP-Bˈ
EIP-C
Ⲵ࠶㊫ˈ䎵ࠪ SJ/T 11363-2006 㿴ᇊⲴ䲀䟿㾱≲ ˄ᵜ㺘ṬѝⲴؑ᚟ӵѪㅖਸ SJ/T11364-2006 ԕ
৺
lj⭥ᆀؑ᚟ӗ૱⊑ḃ᧗ࡦ㇑⨶࣎⌅NJ
㘼ᨀ‫׋‬DŽ
˅
X: indicates that the content of the toxic and hazardous substance in at least one Homogenous
Material of the part, according to EIP-A, EIP-B, EIP-C, exceeds the concentration limit requirement
as described in SJ/T 11363-2006 (Information provided in this table is solely for compliance with SJ/
T11364-2006 and the Management Measures for the Control of Pollution by Electronic Information
Products.)
䟽㾱һ亩 /Importance:
ӗ૱ḷㆮкⲴ⧟‫⭘֯؍‬ᵏ䲀 / Environmental Protection Use Period, EPUP
ḷ䇶㺘⽪൘↔ᵏ䰤޵ˈ൘↓ᑨᐕ֌ᶑԦлˈӗ૱ѝᡰਜ਼ᴹ∂ᡆড䲙⢙䍘ᡆᡀ
࠶нՊਁ⭏⋴┿઼ਈᔲDŽഐ㘼↔㊫ӗ૱Ⲵ֯⭘нՊሬ㠤ԫօѕ䟽Ⲵ⧟ຳ⊑
ḃǃԫօӪ䓛Քᇣᡆ䍒ӗᦏཡDŽнᓄሶ↔ᵏ䰤㿶Ѫ‫؞؍‬ᵏᡆ‫؍‬䇱ᴹ᭸ᵏDŽḷ
ㆮкᑖᴹ⊑ḃ᧗ࡦḷᘇⲴӗ૱ᱟਟഎ᭦ⲴDŽ䈧ṩᦞᖃൠ⌅㿴㾱≲䘋㹼༴⨶DŽ
This symbol indicates that within the specified EPUP, any toxic and hazardous substances
or elements contained within the device will not be disclosed and varied under the normal
operation condition; hence the use of this device will not lead to serious environmental
pollution, personal injury or property damage. It shall not be regarded as a warranty term
or guarantee period. Any device label containing this symbol indicates the device can be
recyclable. Please dispose the device according to local rules and regulations.
50
Consult
instructions
for use
50
0086
Part No. PT00011382
COVIDIEN, COVIDIEN with logo and Covidien logo and Positive
Results for Life are U.S. and internationally registered trademarks of
Covidien AG. Other brands are trademarks of a Covidien company, TM*
brands are trademarks of their respective owner.
May be covered by U.S. Patents: www.covidien.com/patents
©2014 Covidien.
Made in China. Printed in China.
Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
Covidien Ireland Limited, IDA Business & Technology Park,
Tullamore.
www.covidien.com 1-303-530-2300 [T]
1-800-255-8522 [T]
REV 10/2015

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PT00011382 Valleylab LS10 Generator UG.pdf

  • 1. User’s Guide Valleylab TM LS10 LS Series Single Channel Vessel Sealing Generator
  • 2.
  • 3. User’s Guide Valleylab TM LS10 LS Series Single Channel Vessel Sealing Generator For use with software version 1.1x Part Number: PT00011382
  • 4. ii Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 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 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.
  • 5. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator iii 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: 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. ValleylabTM LS10, LS Series Single Channel Vessel Sealing Generator One year from date of shipment All purchased or supplemental software programs or updates 90 days from delivery
  • 6. iv Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 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, non- sublicensable, 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
  • 7. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator v 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 non- COVIDIEN 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
  • 8. vi Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 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.
  • 9. Table of Contents Valleylab LS10, LS Series Single Channel Vessel Sealing Generator vii Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv Chapter 1. Introduction Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Generator Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Generator Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 LigaSure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 LigaSure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Chapter 2. Patient and Operating Room Safety General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Setting Up the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Fire/Explosion Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Implanted Electronic Devices (IEDs) . . . . . . . . . . . . . . . . . . 2-5 Inadvertent Radio Frequency (RF) Burns . . . . . . . . . . . . . . . . . . 2-5 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 A power button to turn the system on and off. . . . . . . . . 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
  • 10. viii Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Chapter 4. Troubleshooting General Troubleshooting Guidelines . . . . . . . . . . . . . . . . . . . . . 4-2 System Alerts and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 4-2 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Correcting Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 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) . . . . . . . . . . . . . . . . . . . . 6-12
  • 11. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator ix Type CF Equipment (IEC 60601-1)/Defibrillator Proof. . . 6-12 Liquid Spillage (IEC 60601-2-2:2006 Clause 44.3 and IEC 60601-2-2:2009 Clause 201.11.6.3) . . . . . . . . . . . . . . . 6-12 Voltage Transients (Emergency Generator Mains Transfer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Output Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19 Maximum Output for LigaSure Mode . . . . . . . . . . . . . . . 6-19 Output Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19 Output Power vs. Resistance Graphs. . . . . . . . . . . . . . . . . . . . . 6-20 LigaSure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20 China RoHS Compliance (applies to China only) . . . . . . . . . . . 6-21
  • 12.
  • 13. Chapter 1 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 1-1 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.
  • 14. 1-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 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.
  • 15. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 1-3 Generator Front Panel Introduction Generator Front Panel ཰ 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 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. ཱི 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. LigaSure 1 2 3 4 6 5
  • 16. 1-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Generator Back Panel Generator Back Panel ཰ Volume knob ཱ Footswitch port ི Serial label ཱི Potential equalization conductor terminal ུ AC Fuse ཱུ AC mains receptacle ྲྀ ECG blanking connector ཷ USB port ླྀ Vent 1 9 8 5 2 3 4 6 7 Warning: Risk of Fire. Replace Fuse as Marked. 250V, F8.0A (100-240)
  • 17. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 1-5 LigaSure Mode Introduction 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. 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. 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.
  • 18.
  • 19. Chapter 2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-1 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.
  • 20. 2-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 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. • In all cases, monitoring systems incorporating high frequency current limiting devices are recommended. A failure of the LS10 could result in an unintended increase of output power. 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.
  • 21. Patient and Operating Room Safety Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-3 General 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. 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. Connect only Covidien approved LS0300 footswitch (purple). Using footswitches from other manufacturers may cause equipment malfunction. 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 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. Precaution
  • 22. 2-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator General 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. 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.
  • 23. Patient and Operating Room Safety Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-5 Inadvertent Radio Frequency (RF) Burns 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. Inadvertent Radio Frequency (RF) Burns LigaSure 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. 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. Warning Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar equipment) can provide a path for high frequency current even if the electrodes or probes are isolated at 50 Hz-60 Hz, insulated, and/or battery operated. Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent electrosurgical burns may result. 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.
  • 24. 2-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator LigaSure 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. 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. Warning
  • 25. Patient and Operating Room Safety Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 2-7 LigaSure LigaSure in Minimally-invasive Procedures Warning For laparoscopic procedures, be alert to these potential hazards: • Laparoscopic surgery may result in gas embolism due to insufflation of gas in the abdomen. • The jaw electrode may remain hot enough to cause burns after the electrosurgical current is deactivated. • Localized burns to the patient or physician may result from electrical currents carried through conductive objects (such as cannulas or scopes). Electrical current may be generated in conductive objects through direct contact with the active electrode, or by the LigaSure instrument (electrode or cable) being in close proximity to the conductive object. • Do not use hybrid trocars that have a non-conductive locking anchor placed over a conductive sleeve. For the operative channel, use all-metal or all-plastic systems. At no time should electrical energy pass through hybrid systems. Capacitive coupling of RF current may cause unintended burns. • When using laparoscopic instrumentation with metal cannulas, the potential exists for abdominal-wall burns to occur due to direct electrode contact or capacitive coupling of RF current. This is most likely to occur in instances where the generator is activated for extended periods at high power levels inducing high-current levels in the cannula. • Ensure that the insulation of single-use and reusable laparoscopic instrumentation is intact and uncompromised. Compromised insulation may lead to inadvertent metal-to-metal sparking and neuromuscular stimulation and/or inadvertent sparking to adjacent tissue. Covidien recommends against the use of laparoscopic surgery on pregnant patients. Warning For laparoscopic procedures, be alert to these potential hazards: • The external surfaces of the LigaSure instrument jaws may remain hot enough to cause burns after the RF current is deactivated. • Inadvertent activation or movement of the activated LigaSure instrument outside of the field of vision may result in injury to the patient. • Do not activate the instrument while the instrument jaws are in contact with, or in close proximity to, other instruments including metal cannulas, as localized burns to the patient or physician may occur. • Do not activate the LigaSure function in an open-circuit condition. Activate the generator only when the instrument is near or in direct contact with the target tissue to reduce the possibility of unintended burns. • Carefully insert and withdraw LigaSure instruments from cannulas to avoid possible damage to the devices and/or injury to the patient.
  • 26. 2-8 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Servicing After Surgery Servicing Warning Electric Shock Hazard Always turn off and unplug the generator before cleaning. Precaution Do not reprocess, reuse, or resterilize instruments labeled “disposable” or “single use only.” Notice Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator. Warning Electric Shock Hazard Do not remove the generator cover. Contact qualified personnel for service. Notice Refer to this system’s service manual for maintenance recommendations, and function and output- power verification procedures. The generator remains connected to mains after shut down by the front panel button. To completely disconnect the generator from mains, detach the power cord from either the wall socket or the appliance connector on the rear panel. Position the generator so it doesn’t block access to the power cord for disconnection.
  • 27. Chapter 3 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 3-1 System Setup This chapter describes how to set up the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator, turn it on, and configure system settings. 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.
  • 28. 3-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator LigaSure Function Overview LigaSure Function Overview The LigaSure vessel sealing mode can be used on arteries, veins, and lymphatics up to and including 7 mm (0.275 inches) in diameter and tissue bundles. This system provides precise energy delivery and electrode pressure to tissues for a controlled period to achieve a complete and permanent fusion of tissues and vessel lumens. The system is designed to produce minimal sticking, charring, and thermal spread to adjacent tissue. The front panel of the generator is divided into 5 functional parts: 1. A power button to turn the system on and off. 2. A system error indicator. 3. A system status indicator that consists of a circle of lights located in the center of the front panel to indicate different system states. 4. An instrument status or switch stuck indicator. 5. One instrument receptacle. Note: Only one LigaSure instrument can be set up at one time. The generator supports a single LigaSure instrument. LigaSure Receptacle The LigaSure receptacle is located on the right side of the front panel labeled with LigaSure. The generator will automatically identify compatible instruments. Refer to the instrument labeling to confirm the compatibility of a specific LigaSure instrument with this generator. Warning Electric Shock Hazard • Do not connect wet instruments to the generator. • Ensure that all instruments are correctly connected and that no metal is exposed at any connection point. Connect compatible instruments to the receptacle properly. Improper connection may result in an inadvertent instrument activation or other potentially hazardous conditions. Follow the instructions provided with LigaSure instruments for proper connection and use. The instrument receptacle on this system is designed to accept only one instrument at a time. The system is a single channel LigaSure generator. Precaution Read the instructions, warnings, and precautions provided with LigaSure instruments before use. Specific instructions are not included in this manual.
  • 29. System Setup Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 3-3 Setup Footswitch The generator is compatible with LigaSure footswitch LS0300 (purple). To activate LigaSure instrument with footswitch, attach a LigaSure footswitch LS0300 (purple) to the footswitch port on the rear panel. The LigaSure instrument with in-line activation functionality does not support footswitch activation. Setup Before Startup 1. Place the generator on a flat, stable surface such as a table, platform, boom system, or cart. Refer to the procedures for your local institution or your local codes. 2. Plug the system power cord into the rear-panel AC mains receptacle. 3. Plug the system power cord into a grounded power outlet. Note: Do not plug into a power strip or extension cord. Note: The generator must be set up using the Valleylab Exchange Remote Software System. For instructions, refer to the First Time Setup Guide or the Valleylab Exchange Remote Software System User’s Guide. The First Time Setup Guide and Valleylab Exchange Remote Software System User’s Guide are available online at www.covidien.com/valleylabexchange. Powering Up the Generator 1. Turn on the system by pressing the power on/off button. Observe the following during the power-up self-test: • System status indicator illuminates white, rotating segment by segment, indicating boot and self-test activity. • A tone sounds upon completion of self-test and system indicator illuminates constant white. 2. If the system does not pass the power-up self-test and an error indicator is displayed, refer to Chapter 4, System Alerts and Troubleshooting section for troubleshooting instructions. Inspect instruments and cords (especially reusable instruments and cords) for breaks, cracks, nicks, and other damage before every use. If damaged, do not use. Failure to observe this precaution may result in injury or electrical shock to the patient or surgical team. Precaution
  • 30. 3-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator LigaSure Instruments LigaSure Instruments Connecting LigaSure Instruments to the Generator Insert a LigaSure connector (1) into the receptacle on the front panel of the generator. • Valid Instrument - If the generator is compatible with the LigaSure instrument, the system status indicator illuminates purple, indicating the system is ready for surgical use. • Invalid instrument - If the generator does not recognize the attached instrument, the light above the receptacle illuminates with a red light for an invalid instrument. Refer to the following steps to resolve the issue. – Confirm the instrument is fully inserted by reconnecting the instrument using firm pressure to insert the instrument into the instrument receptacle. – If the red light above the receptacle continues to appear, use a new, compatible LigaSure instrument. There are several reasons an instrument can be read as invalid, including: • Not recognized • Not compatible • Handswitch or footswitch is stuck 1
  • 31. System Setup Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 3-5 LigaSure Instruments Activating the LigaSure Instrument 1. Activate the LigaSure instrument either by pressing and holding the activation button on the instrument or by stepping on and holding the footswitch pedal. For the duration of energy delivery, the system status indicator illuminates purple, rotating segment by segment, and an activation tone sounds. 2. When the two-pulse seal cycle complete tone is emitted and the system status indicator illuminates solid purple indicating completed seal cycle, release the activation button or footswitch. In the case of an alert condition, refer to the following section. Alert Situations A four-pulse tone will sound when any incomplete seal cycle condition occurs and the center circle on the front panel will illuminate with a solid amber light. When an alert condition occurs, energy delivery will be interrupted. Check Instrument and Reactivate If the incomplete seal cycle is indicated, the user should: 1. Release the footswitch pedal or activation button on the instrument. 2. Open the instrument jaws and inspect for a successful seal. 3. Follow the suggested corrective action. • Regrasp thicker tissue - The user is grasping this tissue or not enough tissue; open the jaws and confirm that a sufficient amount of tissue is inside the jaws. If necessary, increase the amount of tissue and reactivate the seal cycle. • Reinsert electrodes - Electrodes may have become dislodged from the instrument. • Check for clips/regrasp tissue - Avoid grasping objects such as staples, clips, or encapsulated sutures in the jaws of the instrument. • Clean electrode tips - Use a wet gauze pad to clean surfaces and edges of the instrument jaws. • Remove excess fluids - Minimize or remove excess fluids from around the instrument jaws. 4. Hold the handswitch or footswitch until the seal cycle complete tone is heard. 5. If possible, reposition the instrument and regrasp tissue in another location. Reactivate the seal cycle.
  • 32. 3-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator LigaSure Instruments After Surgery 1. Turn off the generator by pressing and holding the power on/off button for three seconds. 2. Disconnect all instruments from the front panel. • If the instrument is a single use only (disposable), dispose of it according to the procedures for your institution. • If the instrument is reusable, clean and sterilize it according to the manufacturer’s instructions for use. 3. Disconnect and store footswitch.
  • 33. Chapter 4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-1 Troubleshooting 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.
  • 34. 4-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator General Troubleshooting Guidelines General Troubleshooting Guidelines If the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator malfunctions, check for obvious conditions that may have caused the problem: • Perform steps outlined in Chapter 4, System Alerts and Troubleshooting section for the specific issue. • Check the system for visible signs of physical damage. • Make sure the fuse drawer is tightly closed. • Verify that all cords are connected and attached properly. • If the problem is still unclear, turn the generator off, then turn it back on. If the malfunction persists, the system may require service. Contact your institution’s biomedical engineering department or Covidien Technical Service as indicated on page 5- 4. System Alerts and Troubleshooting Most system alerts require actions on your part to correct the condition; however, some are corrected automatically. Use the following list to determine how to correct an alert condition. After correcting the alert condition, power cycle the generator, confirm the self- test completes, and returns to ready state as described in Chapter 3, System Setup. Indicators Description Actions Amber color system status indicator and four-pulse tone delivered Seal cycle incomplete Refer to Chapter 3, Check Instrument and Reactivate section
  • 35. Troubleshooting Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-3 General Troubleshooting Guidelines Red instrument status indicator and three-pulse tone delivered Invalid instrument or stuck handswitch or footswitch Check the handswitch and make sure it is released. If the problem remains, remove the instrument and observe the instrument status indicator. 1) If it remains red, the footswitch is depressed. Check the footswitch. 2) If it turns off, the LigaSure handswitch is stuck or an invalid instrument is inserted. Replace with a new LigaSure instrument. Red system error indicator illuminated and three- pulse tone delivered System error Power cycle the generator. If error recurs, system fault is present. Contact Covidien Technical Service as indicated on page 5-4. No audio tone upon attempted activation of footswitch Footswitch fault may be present Confirm instrument is fully inserted in receptacle by removing and reinserting LigaSure connector. Confirm the footswitch plug is fully inserted by reconnecting the plug to ensure pin alignment. Single pulse tone delivered when footswitch pressed, no energy delivered Footswitch activation disabled for connected LigaSure instrument Replace instrument with a footswitch- compatible LigaSure instrument or use handswitch functionality to activate energy. Amber or red usage limit indicator illuminated Inserted device has already been used Replace with certified Covidien LigaSure instrument. Indicators Description Actions
  • 36. 4-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Correcting Malfunctions Service Mode Service mode functionality requires an external PC and manual command entry. See service manual for details. When the system is in service mode, the system status indicator will illuminate white and flash. Cycle power to exit service mode. Correcting Malfunctions If a solution is not readily apparent, use the table below to help identify and correct specific malfunctions. After you correct the malfunction, power cycle the generator, confirm the self-test completes, and returns to ready state as described in Chapter 3, System Setup. White color system status indicator illuminated and flashing System in service mode Cycle the power to exit service mode. Situation Possible Cause Solution Abnormal neuromuscular stimulation (stop surgery immediately) Metal-to-metal sparking Check all connections to the generator and LigaSure instrument and cords for damage. Abnormal 50 Hz-60 Hz leakage currents Contact your biomedical engineering department or a Covidien Technical Service representative for assistance. Indicators Description Actions
  • 37. Troubleshooting Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-5 Correcting Malfunctions Generator does not respond when turned on Disconnected power cord or faulty wall outlet Check power cord connections (generator and wall outlet). Connect the power cord to a functional outlet. Faulty power cord Replace the power cord. Fuse drawer is open or fuses are blown. Replace the blown fuse(s). Close the fuse drawer. Refer to the service manual. Internal component malfunction Use a backup generator. Contact your biomedical engineering department or a Covidien Technical Service representative for assistance. System is on, but did not complete the self-test; system status indicator does not achieve system ready for use status (constant white) Software malfunction Turn off, then turn on the generator. Internal component malfunction Use a backup generator. Contact your biomedical engineering department or a Covidien Technical Service representative for assistance. Generator is on and instrument is activated, but system does not deliver energy Malfunctioning footswitch or handswitching instrument Check and reconnect instrument and/or footswitch connection. Power cycle the generator. Replace the instrument if it continues to malfunction. Internal component malfunction Use a backup generator. Contact your biomedical engineering department or a Covidien Technical Service representative for assistance. Situation Possible Cause Solution
  • 38. 4-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Correcting Malfunctions Incomplete seal cycle alert front panel will illuminate with a solid amber light, a four-pulse tone sounds, and RF output is disabled Excessive tissue/eschar on jaws Clean jaws with a wet gauze pad. Electrodes have come loose from the instrument jaws Electrode pins may have been compromised or bent during assembly of the instrument and may need to be replaced Re-insert the electrode into the instrument jaws making sure that all the electrode pins are firmly seated. If not resolved, replace the LigaSure instrument. Metal or other foreign object is grasped within jaws Avoid grasping objects, such as staples, clips, or encapsulated sutures in the jaws of the instrument. Tissue grasped within jaws is too thin Open the jaws and confirm that a sufficient amount of tissue is inside the jaws. If necessary, increase the amount of tissue and repeat the procedure. Pooled fluids around instrument tip Minimize or remove excess fluids. The seal cycle was interrupted before completion. The handswitch or footswitch was released before the end tone activated. Additional time and energy are needed to complete the seal cycle Reactivate the seal cycle without removing or repositioning the instrument. Continuous patient or video monitor interference Faulty power cord or display cables Check and replace power cord and display cables for the monitor and power cord for the generator. Electrical equipment is grounded to different objects rather than a common ground. The generator may respond to the resulting voltage differences between grounded objects. Plug all electrical equipment into line power at the same location. Contact your biomedical engineering department or a Covidien Technical Service representative for assistance. Malfunctioning monitor Replace the monitor. Situation Possible Cause Solution
  • 39. Troubleshooting Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 4-7 Correcting Malfunctions Interference with other devices only when the generator is activated Metal-to-metal sparking Check all connections to the generator and LigaSure instrument and cords for damage. Electrically inconsistent ground wires in the operating room Verify that all ground wires are as short as possible and go to the same grounded metal. If interference continues when the generator is activated, the monitor is responding to radiated frequencies. Ask your biomedical engineering department to check with the manufacturer of the monitor. Some manufacturers offer RF choke filters for use in monitor leads. The filters reduce interference when the generator is activated. Pacemaker interference Intermittent connections or metal-to-metal sparking Check the active electrode cord connections. It may be necessary to reprogram the pacemaker. Always monitor patients with pacemakers during surgery and keep a defibrillator available. Consult the pacemaker manufacturer or hospital cardiology department for further information when use of the LigaSure system is planned in patients with cardiac pacemakers. Internal Cardiac Defibrillator (ICD) activation ICD is activated by generator Stop the procedure and contact the ICD manufacturer for instructions. Situation Possible Cause Solution
  • 40.
  • 41. Chapter 5 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 5-1 Maintenance and Repair This chapter presents the following information: • The manufacturer’s responsibility • Routine maintenance • Returning the generator for service • Service centers 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.
  • 42. 5-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Responsibility of the Manufacturer Responsibility of the Manufacturer Covidien is responsible for the safety, reliability, and performance of the generator only if all of the following conditions have been met: • Installation and setup procedures in this manual are followed. • Assembly, operation, readjustments, modifications, or repairs are carried out by persons authorized by Covidien. • The electrical installation of the relevant room complies with local codes and regulatory requirements, such as IEC, UL or CSA. • The equipment is used in accordance with the Covidien instructions for use. • Covidien recommends disposal of this equipment according to the local regulation. For warranty information, refer to the Limited Warranty section in this manual. Routine Maintenance and Periodic Safety Checks When should the generator be checked or serviced? Covidien recommends that the generator be inspected by qualified service personnel prior to being placed into service and at least once a year. This inspection should include adjusting the system to factory specifications. When should the power cord be checked or replaced? Check the power cord before each use of the system or at the intervals recommended by your institution. Check the power cord for exposed wires, cracks, frayed edges, or a damaged connector. Replace damaged cords. When should the fuses be replaced? An internal component malfunction can damage the fuses. The system fuses may need to be replaced if the system fails the self-test or if the system stops functioning, even though it is receiving power from a wall outlet. Refer to the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual for instructions. Notice Refer to the generator service manual for maintenance recommendations and function and output power verification procedures.
  • 43. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 5-3 Cleaning Maintenance and Repair Cleaning 1. Turn off the system and unplug the power cord from the wall outlet. 2. Thoroughly wipe all surfaces of the generator and power cord with a damp cloth and mild cleaning solution or disinfectant. The generator will withstand the effects of cleaning over time without degrading the enclosure or display quality. Product Service Covidien recommends that all Valleylab systems be returned to the manufacturer for all service requirements. If any service is required without returning the system to the manufacturer, Covidien recommends that only qualified personnel service the Valleylab system. Covidien defines qualified personnel as a person with electrosurgical equipment repair experience, such as biomedical personnel, and/or individuals who have taken official Covidien training courses. Returning the Generator for Service Before returning the generator, call a Covidien sales representative for assistance. If you are instructed to send the generator to Covidien, do the following: 1. Obtain a return authorization number. Call the Covidien Technical Service Center (see page 5-4) to obtain a Return Authorization Number. Have the following information ready before the call: • Hospital/clinic name/customer number • Telephone number • Department/address, city, state, and zip code • Model number • Serial number • Description of the problem • Type of repair to be done Warning Electric Shock Hazard Always turn off and unplug the generator before cleaning. Notice Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.
  • 44. 5-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Adjustment to Factory Specification (Calibration) 2. Clean generator. See the previous section, Cleaning. 3. Ship the generator. a. Attach a tag to the generator that includes the return authorization number and the information (hospital, phone number, etc.) listed in step 1. b. Be sure the generator is completely dry before packing it for shipment. Package it in its original shipping container, if available. c. Ship the generator, prepaid, to the Covidien Service Center. Adjustment to Factory Specification (Calibration) Covidien recommends that only qualified personnel calibrate the generator. The generator incorporates automatic calibration where possible to reduce the required equipment and manual steps. Software Updates Software updates are available directly from Covidien by using the Valleylab Exchange Remote Software System application. Go to www.covidien.com/valleylabexchange to download and install the latest version of the Valleylab Exchange application. For additional information, the Valleylab Exchange Remote Software System User’s Guide is available on the Valleylab Exchange website. Covidien Technical Service For service, contact Covidien Technical Service or your Covidien sales representative. Contact a Covidien Technical Service representative by telephone, email, or through the Internet: • USA and Canada: 1-800-255-8522 Option 2 • International: 1-303-476-7996 • Email: valleylab.technicalservice@covidien.com • International service centers: www.surgical.com/international-service-centers
  • 45. Chapter 6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-1 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 LigaSure instruments before use. Specific instructions for LigaSure instruments are not included in this manual.
  • 46. 6-2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Performance Characteristics Performance Characteristics General Dimensions and Weight Output configuration Isolated output 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 Width 300 mm (11.81 inches) Depth 377 mm (14.84 inches) Height 105 mm (4.13 inches) Weight 5 Kg (11 lbs)
  • 47. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-3 Performance Characteristics Operating Parameters Transport and Storage Duty Cycle Under maximum-output settings and rated-load conditions (30 ohm load), the generator is suitable for activation times of 5 seconds on, 15 seconds off, for 1 hour. With lesser settings and loads, you can activate the generator for greater durations without generating excessive internal temperatures. Internal Battery Ambient temperature range +10° C to +40° C (50° F to 104° F) Relative humidity 30% to 75% non-condensing Atmospheric pressure 700 to 1060 millibars Warm-up time If transported or stored at temperatures outside the operating temperature range, allow one hour for the generator to reach room temperature before use. Ambient temperature range -30° C to 65° C (-22° F to 149° F) Relative humidity 25% to 85% (non-condensing) Atmospheric pressure 500 to 1060 millibars Duration of storage If stored over one year, see service manual for instructions or contact Covidien Service for further information. Battery for RTC Battery type – 3 V lithium button cell Battery life – 5 years
  • 48. 6-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Performance Characteristics Audio Volume The stated audio levels are at a distance of one meter. Alert tones meet the requirements of IEC60601-2-2. Activation Tone The audio levels stated below are for activation tones and alert tones at a distance of one meter. Alert Tone Volume (adjustable) 45 dBa minimum Frequency (nominal) Sealing in process – 440 Hz Duration Continuous while the system is activated Volume (not adjustable) 65 dBa minimum Frequency Seal cycle incomplete alert – High = 784 Hz, Low = 587 Hz Seal cycle complete tone – 985 Hz System error tone – 1421 Hz Duration 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
  • 49. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-5 Performance Characteristics USB Port The software provides an asynchronous serial-communications interface for communicating with an externally-connected device. 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. Potential Equalization Conductor Terminal A potential equalization conductor terminal is provided to allow connection of the generator to the ground. Radio Frequency Identification (RFID) The RFID module is located above the LigaSure port. The intended use of the RFID module is to identify the inserted LigaSure instrument and configure the generator with the data included in the RFID tag. Frequency Range: 13.56 MHz RF Output Power: 68.17 dBuV/m @ 3 meters Type of Antenna: Integral Loop Antenna Modulation: Amplitude-shift Keying (ASK) Mode of Operation (Simplex/Duplex): Duplex Contains Transmitter Module FCC ID: 2AAVI-JDK1901 Contains IC ID: 11355A-JDK1901 Low Frequency (50/60 Hz) Leakage Current (IEC 60601-2-2) Enclosure source current, ground open < 300 μA Sourcecurrent,patient leads, all outputs 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 Sink current at high line, all inputs < 50 μA
  • 50. 6-6 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Performance Characteristics High Frequency (RF) Leakage Current (IEC 60601-2-2) Input Power Measured with leads recommended by Covidien Measured directly at the system terminals LigaSure leakage <116 mA RMS < 100 mA RMS 120 Volt 240 Volt Maximum power at nominal line voltage: Idle: 35 VA Maximum power at nominal line voltage: Idle: 35 VA Seal: 400 VA Seal: 400 VA Full regulation range: 90 to 130 Vac Full Regulation Range: 180 to 264 Vac Operating Range: 100 to 120 Vac 1) Mains current maximum: 2) Idle: 389 mArms 3) Seal: 4.44 Arms Operating Range: 210 to 240 Vac 1) Mains current maximum: 2) Idle: 194 mArms 3) Seal: 2.22 Arms Mains line frequency range (nominal): 50 to 60 Hz 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 Fuses (2) – 5 mm x 20 mm 8 A, 250 V fast blow, high-breaking capacity Power plug: 3-prong hospital grade connector Power plug: 3-prong locally approved connector
  • 51. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-7 Performance Characteristics 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: • 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 • 220-240 VAC Cable - H05VVF3G1.0 VDE, maximum length 15 ft. (5 m) Plug - minimum 5 A - 250 VAC Unit receptacle - IEC female, minimum 5 A - 250 VAC Input Frequency The generator operates within specification at all line-input frequencies between 48 Hz and 62 Hz. The user does not need to reconfigure the generator 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 generator 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 to external devices that the generator is delivering RF energy. Open the door to the USB/ECG blanking port cover to access the ECG blanking port. 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 rated current and voltage rating of the ECG port is 0.2A at 12VDC. Important Contact your local Covidien representative for alternative internationally approved power-cord options.
  • 52. 6-8 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Standards and IEC Classifications Standards and IEC Classifications The generator meets all pertinent clauses of the IEC 60601-1 and IEC 60601-2-2. The generator 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.
  • 53. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-9 Symbols Symbols Catalogue number Consult instructions for use Manufacturer Authorized representative in the European community Date of manufacture Footswitch Alternating current Potential equalization conductor terminal
  • 54. 6-10 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Symbols Serial number Not made with natural rubber latex Temperature limitations Humidity limitations For sale by prescription only Eurasian conformity mark Russian GOST-R CE mark and notified body number -22°F -30°C 149°F 65°C Temperature limit Humidity limitation 25% 85% ME20 0086
  • 55. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-11 Symbols Volume adjustment for activation tones Equipment should not be disposed in trash. Dispose of this product according to local regulation.
  • 56. 6-12 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Symbols Class I Equipment (IEC 60601-1) Accessible conductive parts cannot become live in the event of a basic insulation failure because of 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 the 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 Generator 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)
  • 57. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-13 Symbols Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) The generator complies with the appropriate IEC 60601-1-2 and IEC 60601-2-2 specifications regarding electromagnetic compatibility. 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) 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. For more information, see Chapter 3, Check Instrument and Reactivate section.
  • 58. 6-14 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Symbols 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 modification 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 CISPR 11 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 equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense: 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).
  • 59. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-15 Symbols The essential performance requirement per IEC 60601-1 does not apply to the generator. Basic Safety is the performance requirement used during immunity testing. 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 assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The Valleylab Single Channel Vessel Sealing Generator must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The Valleylab Single Channel Vessel Sealing Generator is a group 2 equipment. According to IEC 60601-2- 2:2009 clause 202.6.1.1.1 bb) it is tested in idle mode using CISSPR 11 group 1 limits. RF emissions CISPR 11 Class A The Valleylab Single Channel Vessel Sealing Generator is suitable for use in all establishments other than domestic and those directly connected to the public low- voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies
  • 60. 6-16 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Symbols 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 assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 8 kV contact ± 15 kV air ± 8 kV contact ± 15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst IEC 61000-4-4 ± 2 kV for power supply lines ± 1 kV for input/ output lines ± 2 kV for power supply lines ± 1 kV for input/ output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC IEC 61000-4-5 ± 1 kV differential mode ± 2 kV common mode ± 1 kV differential mode ± 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 < 5% UT (> 95% dip in UT) for 0.5 cycle < 40% UT (> 60% dip in UT) for 5 cycles < 70% UT (> 30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT) for 5 sec 0% UT for 1 cycle < 5% UT (> 95% dip in UT) for 0.5 cycle < 40% UT (> 60% dip in UT) for 5 cycles < 70% UT (> 30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT) for 5 sec 0% UT for 1 cycle Mains power quality should be that of a typical commercial or hospital environment. Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Continued NOTE: UT is the a.c. mains voltage prior to the application of the test level.
  • 61. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-17 Symbols 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 Valleylab LS10 LS Series Single Channel Vessel Sealing Generator should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the generator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 7 Vrms d=1.2P Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 7 V/m d=1.2P 80 MHz to 800 MHz d=2.3P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya , should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol. Continued NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
  • 62. 6-18 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Symbols a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the generator is used exceeds the applicable RF compliance level above, the generator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the generator. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communication equipment and the Valleylab LS10 LS Series Single Channel Vessel Sealing Generator The generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d=0.5 x P 80 MHz to 800 MHz d=0.5 x P 800 MHz to 2.5 GHz d= P 0.01 0.05 0.05 0.1 0.1 0.16 0.16 0.32 1 0.5 0.5 1 10 1.6 1.6 3.2 100 5 5 10 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Guidance and manufacturer’s declaration - electromagnetic immunity
  • 63. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-19 Output Characteristics Output Characteristics Maximum Output for LigaSure Mode Power readouts agree with actual power into rated load to within 15% or 5 W, whichever is greater. Output Waveforms LigaSure vessel sealing technology, an automatic adjustment, controls all modes. As tissue resistance increases throughout the seal cycle, the generator modulates current and voltage until tissue resistance meets seal complete requirements as needed by the tissue- sensing technology. Precaution To avoid injury to the patient or surgical team, use only instruments rated for use at, or greater than, the maximum peak voltages listed below. For example, bipolar instruments must have voltage ratings of 250 V peak or greater, as shown in the “Open Circuit Peak Voltage (max)” column. Mode Open Circuit PeakVoltage (max) Open Circuit P–P Voltage (max) Rated Load (max) Power (max) Output Frequency Current R.M.S (max) LigaSure 250 V 500 V 30 Ω 270 W 400 kHz 5.5 A
  • 64. 6-20 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Output Power vs. Resistance Graphs Output Power vs. Resistance Graphs LigaSure Output power versus impedance for LigaSure power ཰ Output power (watts) ཱ Load resistance (ohms) Nominal power curve for an output power of 270 W at rated load with current/voltage limits per the power curve table. Power curve represents the operational envelope, which varies. Power Curve Limits [W] Load (ohms) nominal high low 5 106.6 137.5 81.7 10 185.6 227.9 142.2 20 250.5 301.0 197.7 30 261.8 314.2 209.2 50 245.3 294.9 187.6 200 88.7 111.8 66.1 500 38.0 49.0 28.2 1000 19.5 25.3 14.5
  • 65. Technical Specifications Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-21 China RoHS Compliance (applies to China only) California Proposition 65 Statement For information regarding California Proposition 65, please refer to www.covidien.com/caprop65. China RoHS Compliance (applies to China only) Hazardous Substance Table (Part Name) (Toxic and Hazardous Substances or Elements) (Pb) (Hg) (Cd) (CR(VI)) (PBB) (PBDE) 㓴㻵ঠࡧ⭥ 䐟ᶯਜ਼⭥⊐ǃ Րᝏಘ (Main PCBA including battery cell and sensors) X O O O O O LED ᱮ⽪ (LED Display) O O O O O O ⭥Ⓚ⁑ඇ (PSU) X O O O O O VIBE™*⁑ඇ (VIBE Module) X O O O O O ⭥Ⓚ㓯 (Power Cord) O O O O O O 䠁኎䜘Ԧ (Metal parts) O O O O O O ກᯉ䜘Ԧ (Plastic parts) O O O O O O ₑ㜦䜘Ԧ (Rubber parts) O O O O O O ⭥㔶㓴Ԧਜ਼ 仾ᡷ (Cable assembly including fans) O O O O O O ㍗പԦ (Fasteners) O O O O O O ⌑ỹ䜘Ԧ (Foam parts) O O O O O O
  • 66. 6-22 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator China RoHS Compliance (applies to China only) O: 㺘⽪䈕ᴹ∂ᴹᇣ⢙䍘൘䈕䜘Ԧᡰᴹ൷䍘ᶀᯉѝⲴਜ਼䟿 , ᤹➗㓴ᡀঅ‫ݳ‬ EIP-AˈEIP-BˈEIP-C Ⲵ࠶ ㊫ , ൷൘ SJ/T 11363-2006 㿴ᇊⲴ䲀䟿㾱≲ԕлDŽ O: indicates that the content of the toxic and hazardous substance in all the Homogenous Materials of the part, according to EIP-A, EIP-B, EIP-C, is below the concentration limit requirement as described in SJ/T 11363-2006. X: 㺘⽪䈕ᴹ∂ᴹᇣ⢙䍘㠣ቁ൘䈕䜘ԦⲴḀа൷䍘ᶀᯉѝⲴਜ਼䟿 , ᤹➗㓴ᡀঅ‫ݳ‬ EIP-AˈEIP-Bˈ EIP-C Ⲵ࠶㊫ˈ䎵ࠪ SJ/T 11363-2006 㿴ᇊⲴ䲀䟿㾱≲ ˄ᵜ㺘ṬѝⲴؑ᚟ӵѪㅖਸ SJ/T11364-2006 ԕ ৺ lj⭥ᆀؑ᚟ӗ૱⊑ḃ᧗ࡦ㇑⨶࣎⌅NJ 㘼ᨀ‫׋‬DŽ ˅ X: indicates that the content of the toxic and hazardous substance in at least one Homogenous Material of the part, according to EIP-A, EIP-B, EIP-C, exceeds the concentration limit requirement as described in SJ/T 11363-2006 (Information provided in this table is solely for compliance with SJ/ T11364-2006 and the Management Measures for the Control of Pollution by Electronic Information Products.) 䟽㾱һ亩 /Importance: ӗ૱ḷㆮкⲴ⧟‫⭘֯؍‬ᵏ䲀 / Environmental Protection Use Period, EPUP ḷ䇶㺘⽪൘↔ᵏ䰤޵ˈ൘↓ᑨᐕ֌ᶑԦлˈӗ૱ѝᡰਜ਼ᴹ∂ᡆড䲙⢙䍘ᡆᡀ ࠶нՊਁ⭏⋴┿઼ਈᔲDŽഐ㘼↔㊫ӗ૱Ⲵ֯⭘нՊሬ㠤ԫօѕ䟽Ⲵ⧟ຳ⊑ ḃǃԫօӪ䓛Քᇣᡆ䍒ӗᦏཡDŽнᓄሶ↔ᵏ䰤㿶Ѫ‫؞؍‬ᵏᡆ‫؍‬䇱ᴹ᭸ᵏDŽḷ ㆮкᑖᴹ⊑ḃ᧗ࡦḷᘇⲴӗ૱ᱟਟഎ᭦ⲴDŽ䈧ṩᦞᖃൠ⌅㿴㾱≲䘋㹼༴⨶DŽ This symbol indicates that within the specified EPUP, any toxic and hazardous substances or elements contained within the device will not be disclosed and varied under the normal operation condition; hence the use of this device will not lead to serious environmental pollution, personal injury or property damage. It shall not be regarded as a warranty term or guarantee period. Any device label containing this symbol indicates the device can be recyclable. Please dispose the device according to local rules and regulations. 50
  • 67.
  • 68. Consult instructions for use 50 0086 Part No. PT00011382 COVIDIEN, COVIDIEN with logo and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company, TM* brands are trademarks of their respective owner. May be covered by U.S. Patents: www.covidien.com/patents ©2014 Covidien. Made in China. Printed in China. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. www.covidien.com 1-303-530-2300 [T] 1-800-255-8522 [T] REV 10/2015