Valleylab ls10 User Guide PDF
Valleylab ls10 User Guide PDF
Valleylab ls10 User Guide PDF
Valleylab LS10
TM
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
Precaution
Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.
Notice
Indicates a hazard which may result in product damage.
Important
Indicates an operating tip or maintenance suggestion.
Limited Warranty
Covidien warrants each covered product listed below to be free from defects in material
and workmanship for normal use and service for the period(s) set forth below. Covidien’s
obligation under this warranty is limited to the repair or replacement, at its sole option, of
any product, or part thereof, which has been returned to it (or its authorized distributor)
within the applicable time period shown below after delivery of the product to the original
purchaser, and which examination discloses, to Covidien’s satisfaction, that the product is
defective. This limited warranty does not apply to any product, or part thereof, which has
been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or
reliability, or which has been subjected to misuse, neglect, or accident.
The warranty periods for Covidien products are as follows:
ValleylabTM LS10, LS Series Single Channel One year from date of shipment
Vessel Sealing Generator
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
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
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.
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii
Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Chapter 1. Introduction
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Generator Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Generator Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
LigaSure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Chapter 2. Patient and Operating Room Safety
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Setting Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Fire/Explosion Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Implanted Electronic Devices (IEDs) . . . . . . . . . . . . . . . . . . 2-4
Inadvertent Radio Frequency (RF) Burns . . . . . . . . . . . . . . . . . . 2-5
LigaSure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
LigaSure in Minimally-invasive Procedures . . . . . . . . . . . . 2-7
After Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Chapter 3. System Setup
LigaSure Function Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
LigaSure Receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Before Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Powering Up the Generator . . . . . . . . . . . . . . . . . . . . . . . . 3-3
LigaSure Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Connecting LigaSure Instruments to the Generator . . . . . 3-4
Activating the LigaSure Instrument . . . . . . . . . . . . . . . . . . 3-5
Alert Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
After Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Chapter 4. Troubleshooting
General Troubleshooting Guidelines . . . . . . . . . . . . . . . . . . . . . 4-2
System Alerts and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 4-2
Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Correcting Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
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.
Introduction
Generator Front Panel
2 3 4 5
6
1
LigaSure
① Power button - Power on: Push and release. Power off: Push and hold for 3
seconds.
② System error indicator - Lights up as shown upon a system error in the generator.
Restart the generator. If the error occurs again, contact local technical service or
Covidien Technical Service.
③ System status indicator -
• White:
• In motion - System is performing a self test.
• Constant - Ready for use, insert LigaSure instrument.
• Flashing - System in service mode, power cycle system for clinical use.
• Purple - Ready for sealing/seal cycle complete.
• Purple in motion - Sealing in process.
• Amber - Seal cycle incomplete alert. Inspect, regrasp, and reactivate sealing and
complete the seal cycle.
④ Usage limit indicator - When illuminated, indicates the inserted device has already
been used. It has not been recertified by the original manufacturer.
⑤ Instruments status or switch stuck indicator -
• Red - Instrument error or hand/footswitch stuck. Instrument may be invalid,
damaged, or incompatible. Check that compatible LigaSure instrument is in proper
working condition and no activation switches are depressed.
⑥ Instrument port - Connect LigaSure instruments when the system status indicator is
white.
1 2 3 4
9 8 7 6
① Volume knob
② Footswitch port
③ Serial label
④ Potential equalization conductor terminal
⑤ AC Fuse
⑥ AC mains receptacle
⑦ ECG blanking connector
⑧ USB port
⑨ Vent
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.
Warning
Do not attempt to fuse lung tissue with LigaSure mode or instruments without first consulting the
respective instrument instructions for use for indicating such use.
LigaSure Instruments
The LigaSure instruments that complete the Valleylab vessel sealing system include
reusable and single-use instruments for open and minimally-invasive procedures. Each
reusable instrument requires a corresponding single-use electrode. The LigaSure function
is only available when using Covidien LigaSure instruments.
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.
General
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).
Precaution
Read all warnings, precautions, and instructions provided with this generator before using.
Read the instructions, warnings, and precautions provided with LigaSure instruments before using.
Specific instructions for LigaSure instruments are not included in this manual.
Examine all instruments and connections to the system before using. Ensure that the LigaSure
instruments function as intended. Improper connection may result in arcs, sparks, instrument
malfunction, or unintended surgical effects.
Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical
team when the generator is delivering RF energy.
Precaution
A non-functioning generator may cause interruption of surgery. A backup system should be
available for use.
Inadvertent activation may occur while installing or removing jaw electrode plates on compatible
LigaSure Instruments. Ensure that the instrument cord is not connected to the generator or that
the system is OFF.
When using a smoke evacuator in conjunction with the generator, set the system volume control
at a level that ensures that the activation tones can be heard.
Use caution if stacking equipment on top of the generator or placing the generator on top of
electrical equipment. This is an unstable configuration and does not allow for adequate cooling.
Safety
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.
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.
Warning
Fire Hazard Sparking and heating associated with vessel sealing technology can be an ignition
source. Keep gauze and sponges wet. Keep electrosurgical electrodes away from flammable
materials and oxygen (O2) enriched environments.
Use of vessel sealing technology in O2 rich environments increases the risk of fire. Therefore, take
measures to reduce the O2 concentration at the surgical site.
Avoid enriched O2 and nitrous oxide (N2O) atmospheres near the surgical site. Both O2 and N2O
support combustion and may result in fires and burns to patients or surgical personnel.
If possible, stop supplemental oxygen at least one minute before and during use of vessel sealing
technology.
Do not activate the generator until flammable vapors from skin-preparation solutions and tinctures
have dissipated.
Avoid the accumulation of naturally occurring flammable gases that may accumulate in body
cavities such as the bowel.
Prevent pooling of flammable fluids and the accumulation of flammable or oxidizing gases or
vapors under surgical drapes or near the surgical site.
Tissue buildup (eschar) on LigaSure electrodes may create embers that pose a fire hazard, especially
in oxygen-enriched environments. Keep the electrode clean and free of all debris.
Facial and other body hair is flammable. Water soluble surgical lubricating jelly may be used to
cover hair close to the surgical site to decrease flammability.
Verify that all anesthesia circuit connections are leak free before and during use of vessel sealing
technology.
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.
Warning
If the patient has an IED, contact the IED manufacturer for instructions before use. Vessel sealing
technology may cause multiple activations of ICDs, or interfere with the intended function of other
IEDs.
Safety
electrosurgical burns may result.
LigaSure
Warning
LigaSure instruments are intended for use only with compatible Covidien generators and energy
platforms. See the instrument instructions for use for a list of compatible generators.Use of these
instruments with other generators may not result in electrical output for which these instruments
were designed and may not result in the desired clinical effect.
If the Seal Cycle Complete tone has not sounded, an optimal seal may not have been achieved.
Reactivate the RF energy until a Seal Cycle Complete tone is heard.
The LigaSure vessel sealing function has not been shown to be effective for tubal sterilization or
tubal coagulation for sterilization procedures. Do not use this function for these procedures.
Use caution during surgical cases in which patients exhibit certain types of vascular pathology
(atherosclerosis, aneurysmal vessels, etc.). For best results, apply the seal to unaffected vasculature.
Do not activate the generator in the LigaSure mode until the vessel sealing instrument has been
applied with the proper pressure. Activating the generator before this is done will result in an
improper seal and may increase thermal spread to tissue outside the surgical site.
Vessel sealing requires the application of RF energy and pressure from the instrument. Tissue to be
sealed must be firmly grasped between the instrument jaw electrodes. Tissue in the jaw hinge or
outside the instrument jaw will not be sealed even if thermal blanching occurs.
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.
Warning
Conductive fluids (e.g, blood or saline) in direct contact with LigaSure instruments or in close
proximity may carry electrical current or heat, which may cause unintended surgical effects or
burns.
Precaution
Read the instructions, warnings, and precautions provided with LigaSure instruments before using.
Specific instructions for LigaSure instruments are not included in this manual.
Inspect instruments and cords for breaks, cracks, nicks, and other damage before every use. If
damaged, do not use. Damaged instruments or cords may result in injury or electrical shock to the
patient or surgical team.
Use only instruments that can withstand the maximum output (peak) voltage for each output
mode as listed in Chapter 6, Technical Specifications. Using an instrument with a voltage rating
that is lower than the maximum output voltage may result in injury to the patient or the operator,
or damage to the instrument.
All compatible Covidien instruments have voltage ratings that are greater than the maximum
output voltages in the generator.
Position patient leads and instrument cords in such a way that contact with the patient or other
leads or cords is avoided.
Energy-based devices, such as electrosurgical pencils or ultrasonic scalpels, that are associated with
thermal spread should not be used to transect seals.
• 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
• Do not use hybrid trocars that have a non-conductive locking anchor placed over a conductive
Safety
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.
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.
After Surgery
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.
Servicing
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.
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.
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.
Precaution
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.
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.
System Setup
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.
LigaSure Instruments
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.
System Setup
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.
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.
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.
Amber color system status Seal cycle incomplete Refer to Chapter 3, Check Instrument
indicator and four-pulse and Reactivate section
tone delivered
Red instrument status Invalid instrument or Check the handswitch and make sure
indicator and three-pulse stuck handswitch or it is released. If the problem remains,
tone delivered footswitch remove the instrument and observe
the instrument status indicator.
Red system error indicator System error Power cycle the generator. If error
illuminated and three- recurs, system fault is present.
pulse tone delivered Contact Covidien Technical Service as
indicated on page 5-4.
No audio tone upon Footswitch fault may be Confirm instrument is fully inserted in
attempted activation of present receptacle by removing and
footswitch reinserting LigaSure connector.
Confirm the footswitch plug is fully
inserted by reconnecting the plug to
ensure pin alignment.
Amber or red usage limit Inserted device has Replace with certified Covidien
indicator illuminated already been used LigaSure instrument.
Troubleshooting
White color system status System in service mode Cycle the power to exit service mode.
indicator illuminated and
flashing
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.
Generator does not respond Disconnected power cord or Check power cord connections
when turned on faulty wall outlet (generator and wall outlet).
Connect the power cord to a
functional outlet.
System is on, but did not Software malfunction Turn off, then turn on the
complete the self-test; generator.
system status indicator does
not achieve system ready for Internal component Use a backup generator.
use status (constant white) malfunction Contact your biomedical
engineering department or a
Covidien Technical Service
representative for assistance.
Incomplete seal cycle Excessive tissue/eschar on jaws Clean jaws with a wet gauze
alert front panel will pad.
illuminate with a solid
amber light, a four-pulse Electrodes have come loose Re-insert the electrode into the
tone sounds, and RF output from the instrument jaws instrument jaws making sure
is disabled that all the electrode pins are
Electrode pins may have been
firmly seated. If not resolved,
compromised or bent during
replace the LigaSure
assembly of the instrument
instrument.
and may need to be replaced
Continuous patient or video Faulty power cord or display Check and replace power cord
monitor interference cables and display cables for the
monitor and power cord for
the generator.
Internal Cardiac Defibrillator ICD is activated by generator Stop the procedure and
(ICD) activation contact the ICD manufacturer
for instructions.
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.
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.
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.
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.
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.
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.
Performance Characteristics
General
Operating Parameters
Technical Specifications
the operating temperature range, allow one hour
for the generator to reach room temperature
before use.
Duration of storage If stored over one year, see service manual for
instructions or contact Covidien Service for further
information.
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
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
Frequency Seal cycle incomplete alert – High = 784 Hz, Low = 587
Hz
Seal cycle complete tone – 985 Hz
System error tone – 1421 Hz
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.
Technical Specifications
generator to the ground.
Input Power
Operating Range: 100 to 120 Vac Operating Range: 210 to 240 Vac
1) Mains current maximum: 1) Mains current maximum:
Mains line frequency range (nominal): Mains line frequency range (nominal):
50 to 60 Hz 50 to 60 Hz
Technical Specifications
• 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
Important
Contact your local Covidien representative for alternative internationally approved power-cord
options.
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.
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.
Symbols
Catalogue number
Technical Specifications
Manufacturer
Date of manufacture
Footswitch
Alternating current
Serial number
149°F
65°C
Temperature limitations
-22°F
-30°C
Temperature
limit
85%
Humidity limitations
25%
Humidity
limitation
Russian GOST-R
ME20
Technical Specifications
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.
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.
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
Technical Specifications
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).
Output Characteristics
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.
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.
LigaSure
Output power versus impedance for LigaSure power
Technical Specifications
① Output power (watts)
② 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.
组装印刷电
路板含电池、 X O O O O O
传感器
(Main PCBA
including battery
cell and sensors)
LED 显示 O O O O O O
(LED Display)
电源模块 X O O O O O
(PSU)
VIBE 模块 X O O O O O
(VIBE Module)
电源线 O O O O O O
(Power Cord)
金属部件 O O O O O O
(Metal parts)
塑料部件 O O O O O O
(Plastic parts)
橡胶部件 O O O O O O
(Rubber parts)
电缆组件含 O O O O O O
风扇
(Cable
assembly
including fans)
紧固件 O O O O O O
(Fasteners)
泡棉部件 O O O O O O
(Foam parts)
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: 表示该有毒有害物质至少在该部件的某一均质材料中的含量 , 按照组成单元 EIP-A,EIP-B,EIP-C
的分类,超出 SJ/T 11363-2006 规定的限量要求 (本表格中的信息仅为符合 SJ/T11364-2006 以
及《电子信息产品污染控制管理办法》而提供。)
X: indicates that the content of the toxic and hazardous substance in at least one Homogenous
Technical Specifications
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.)
重要事项 /Importance:
50
标识表示在此期间内,在正常工作条件下,产品中所含有毒或危险物质或成
分不会发生泄漏和变异。因而此类产品的使用不会导致任何严重的环境污
染、任何人身伤害或财产损失。不应将此期间视为保修期或保证有效期。标
签上带有污染控制标志的产品是可回收的。请根据当地法规要求进行处理。
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.