ligasure_user_s_guide_jan_2006.pdf
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User’s Guide
LigaSure™ Vessel Sealing
Generator
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This manual 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 Valleylab LigaSure™ vessel
sealing generator only. Additional technical information is available in the
LigaSure™ Vessel Sealing Generator Service Manual.
Caution
Federal (USA) laws restrict this device to sale by or on the order of a physician.
Equipment covered in this manual
Valleylab LigaSure™ vessel sealing generator – 120 V/240 V
Valleylab Part Number 1001617
Effective Date January 2006
Trademark acknowledgments
LigaSure™, LigaSure Atlas™, LigaSure Precise™, Instant Response™, and
smart™ connector are trademarks of Valleylab. Klenzyme™ is a trademark of the
STERIS Corporation. Enzol™ is a trademark of Johnson & Johnson Medical Inc.
Patents
One or more of the following U.S. patents and corresponding foreign patents
cover the LigaSure vessel sealing generator and accessories:
5,776,130
6,228,083
6,682,528
5,599,344
6,277,117
6,685,701
5,720,744
6,398,779
6,726,686
5,827,271
6,402,743
6,743,229
6,033,399
6,451,018
D-424,694
6,039,733
6,464,704
D-425,201
6,050,996
6,458,130
D-449,886
6,068,627
6,511,480
D-457,958
6,179,834
6,585,735
D-457,959
Additional patents pending.
Manufactured by
Valleylab, a division of Tyco Healthcare Group LP
Boulder, Colorado 80301-3299 USA
European Representative
Tyco Healthcare UK Ltd.
Gosport, PO13 0AS, UK
For information call
1-303-530-2300
0086
ii
Made in USA
Printed in USA
©2004, 2006 Valleylab All rights reserved.
LigaSure User’s Guide
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Conventions Used in this Guide
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
Caution
Indicates a hazardous situation which, if not avoided, may result in minor or
moderate injury.
Notice
Indicates a hazard that may result in product damage.
Important
Indicates an operating tip or maintenance suggestion.
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Service Centers
Valleylab
Boulder, Colorado, 80301-3299
USA
Ph: 303-530-2300
Toll Free: 800-255-8522
Tyco Healthcare Nederland B.V.
Technical Service Center
De Beverspijken 37
5221 EE ’s-Hertogenbosch
THE NETHERLANDS
Ph: 073-6312412
Fax: 073-6314540
Auto Suture France S.A.
2, rue Denis Diderot
La Clef de Saint Pierre
78990 Elancourt, FRANCE
Ph: 33 (0)1 30 79 80 40
Fax: 33 (0)1 30 79 85 73
Tyco Healthcare Deutschland
Tempelsweg 26
47918 Tonisvorst, GERMANY
Ph: 49 (0)2151 7096 92
Fax: 49 (0)2151 7096 67
For the UK, Europe,
Middle East & Africa:
Tyco Healthcare UK Limited
Valleylab Service Centre
Unit 1a
Corinium Industrial Estate
Raans Road
Amersham
Bucks. HP6 6YJ
UNITED KINGDOM
Ph: 44 (0)1494 789200
FAX: 44 (0)1494 789239
Tyco Healthcare Italia SpA
Via Gaetano Crespi, 12
20134 Milano, ITALY
Ph: 39 02 212181
Fax: 39 02 2640059
Tyco Healthcare Spain S.L.
C/Fructuos Gelabert, 6 – 8 planta 8a,
08970 – Saint Joan DESPI
Barcelona
SPAIN
Ph: 34-93-680-3370
Fax: 34-93-680-2457
iv
Tyco Healthcare Belgium B.V.
Generaal De Wittelaan 9/5
B-2800 Mechelen
BELGIUM
Ph: 32-15-298111
Fax: 32-15-217987
Tyco Healthcare Austria GmbH
Jochen Rindt Str. 37
A-1230 Vienna
AUSTRIA
Ph: 43-1-610-3441
Fax: 43-1-615-3808
Tyco Healthcare Norden AB
(Denmark, Finland, Iceland, Norway,
Sweden)
Årstaängsvägen 11 B, II
SE-117 43þ Stockholm
SWEDEN
Ph. +46 8 585 605 00
Fax +46 8 585 605 06
Tyco Healthcare PTY Ltd
Service & Technical Support
59 - 69 Halstead Street
Hurstville NSW 2220
AUSTRALIA
Ph: 61 2 9579 6066
Toll free hotline: 1800 350 702
Fax: 61 2 9585 1908
Tyco Healthcare Japan
Regulatory Affairs Department
Technical Support Section
Customer Call Center
1-2-20 Heiwajima Ota-ku Tokyo-to
JAPAN
Toll Free : 0120-073-008
Ph: 03-3764-0733
Fax: 03-3764-0744
Auto Suture Company, Canada
4490 Garand Street
Ville St. Laurent
Quebec, CANADA H4R 2A2
Ph: 514-334 -7602
Fax: 514-331-5983
LigaSure User’s Guide
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Conventions Used in this Guide .......................................................................................................................... iii
Service Centers ...................................................................................................................................................... iv
Chapter 1. Introduction
Vessel Sealing ......................................................................................................................................................1-2
Bipolar Modes .......................................................................................................................................................1-2
Instant Response Technology............................................................................................................................1-3
Accessories ...........................................................................................................................................................1-3
Chapter 2. Controls and Receptacles
Front Panel ............................................................................................................................................................2-2
Vessel Sealing Controls ............................................................................................................................2-4
Rear Panel ............................................................................................................................................................2-8
Bipolar Footswitch Receptacle (blue) ......................................................................................................2-9
Chapter 3. Patient and Operating Room Safety
General ..................................................................................................................................................................3-2
Fire/Explosion..............................................................................................................................................3-3
Fire Hazard with Oxygen Circuit Connections .......................................................................................3-3
Electrosurgical Smoke ...............................................................................................................................3-3
Inadvertent Radiofrequency Burns ..........................................................................................................3-4
Ensure Proper Connections ......................................................................................................................3-4
Instrument Cords ........................................................................................................................................3-4
Servicing ......................................................................................................................................................3-4
Before Surgery......................................................................................................................................................3-5
Active Instruments ......................................................................................................................................3-5
Generator .....................................................................................................................................................3-5
During Surgery......................................................................................................................................................3-6
Generator Power Settings .........................................................................................................................3-6
Contact with Metal Objects .......................................................................................................................3-6
Active Accessories .....................................................................................................................................3-6
Laparoscopic LigaSure Instrument Procedures ....................................................................................3-7
Open LigaSure Instrument Procedures ..................................................................................................3-7
After Surgery .........................................................................................................................................................3-8
Chapter 4. Before Surgery
Quick Setup Instructions .....................................................................................................................................4-2
Setting Up the Generator ....................................................................................................................................4-3
Preparing for Surgery ..........................................................................................................................................4-4
Footswitch Connections ............................................................................................................................4-5
Instrument Connections .............................................................................................................................4-5
Vessel Sealing Instrument Connection ...................................................................................................4-5
Set the Output for the Vessel Sealing Mode ..........................................................................................4-6
Set the Output for the Bipolar Mode ........................................................................................................4-7
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Chapter 5. During Surgery
Checking Accessory Connections ..................................................................................................................... 5-2
Changing the Power or Intensity Setting .......................................................................................................... 5-2
Vessel Sealing ............................................................................................................................................ 5-2
Activating the Surgical Instrument ..................................................................................................................... 5-3
Regrasp Indicator ....................................................................................................................................... 5-4
Adjusting the Volume of Activation Tones ....................................................................................................... 5-5
Responding to Alarms ......................................................................................................................................... 5-5
Chapter 6. After Surgery
Preparing the Generator for Reuse ................................................................................................................... 6-2
Disconnect the Accessories ..................................................................................................................... 6-2
Clean the Generator .................................................................................................................................. 6-2
Reprocessing Instruments .................................................................................................................................. 6-2
Clean the Reusable Instrument ............................................................................................................... 6-2
Sterilization Parameters ............................................................................................................................ 6-3
Storing the Generator .......................................................................................................................................... 6-3
Chapter 7. Troubleshooting
General Troubleshooting Guidelines ................................................................................................................ 7-2
Correcting Malfunctions ...................................................................................................................................... 7-3
Responding to System Malfunctions ................................................................................................................ 7-6
Chapter 8. Maintenance and Repair
Responsibility of the Manufacturer .................................................................................................................... 8-2
Routine Maintenance .......................................................................................................................................... 8-2
Returning the Generator for Service ................................................................................................................. 8-3
Obtain a Return Authorization Number................................................................................................... 8-3
Clean the Generator .................................................................................................................................. 8-3
Ship the Generator ..................................................................................................................................... 8-3
Chapter 9. Technical Specifications
Performance Characteristics .............................................................................................................................. 9-2
General ........................................................................................................................................................ 9-2
Dimensions and Weight ............................................................................................................................ 9-2
Operating Parameters ............................................................................................................................... 9-2
Transport and Storage............................................................................................................................... 9-3
Duty Cycle ................................................................................................................................................... 9-3
Internal Memory .......................................................................................................................................... 9-3
Audio Volume .............................................................................................................................................. 9-3
Serial Port .................................................................................................................................................... 9-4
RF Activation Port ...................................................................................................................................... 9-4
Expansion Port ........................................................................................................................................... 9-5
Low Frequency (50-60 Hz) Leakage Current (AAMI HF-18-1993) .................................................... 9-5
High Frequency (RF) Leakage Current (IEC 601-2-2) ......................................................................... 9-5
Input Power ................................................................................................................................................. 9-6
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Power Cord Specification ..........................................................................................................................9-6
Standards and IEC Classifications ....................................................................................................................9-7
Class I Equipment (IEC 60601-1) ............................................................................................................9-7
Type CF Equipment (IEC 60601-1)/Defibrillator Proof .........................................................................9-7
Static Electricity Discharge Interference (IEC 60601-1-2 and IEC 80801-2) ....................................9-8
Electromagnetic Interference ....................................................................................................................9-8
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) .................................................9-8
Voltage Transients (Emergency Generator Mains Transfer) ...............................................................9-8
Output Characteristics .........................................................................................................................................9-9
Maximum Generator Output .....................................................................................................................9-9
Output Waveform........................................................................................................................................9-9
Output Power vs. Resistance Graphs .............................................................................................................9-12
Chapter 10. Warranty
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LigaSure User’s Guide
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Chapter
1
Introduction
This section includes information about:
• LigaSure vessel sealing technology
• Bipolar modes
• Instant Response technology
Caution
Read all warnings, cautions, and instructions provided with this generator before
using.
Read the instructions, warnings, and cautions provided with instruments and
accessories before using. Specific instructions are not included in this manual.
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Vessel Sealing
The LigaSure vessel sealing generator is an isolated output generator that
provides power for vessel sealing and bipolar surgery.
It includes the following features:
•
LigaSure vessel sealing technology
•
Vessel sealing Regrasp indicator that alerts you to situations where a full seal
cycle has not been achieved
•
Bipolar and macrobipolar modes
•
Instant Response technology
•
Memory button to recall prior intensity and power settings used
•
Smart interface for connecting a Valleylab LigaSure instrument or smart
connector adapter
•
Adjustable activation tone volume
•
Handswitch or footswitch activation
•
RF activation port, RS-232 serial port, and expansion port
Vessel Sealing
The LigaSure vessel sealing system can be used on vessels and tissue bundles up
to and including 7 mm in diameter. This system provides precise energy delivery
and electrode pressure to vessels for a controlled time period to achieve a
complete and permanent tissue fusion. The system has been optimized to produce
minimal sticking, charring, or thermal spread to adjacent tissue.
Bipolar Modes
Two modes are available: bipolar and macrobipolar.
1-2
•
Bipolar may be used for most applications. The voltage is kept low to prevent
sparking. The power remains constant over a specific range of tissue
resistance, allowing a consistent tissue effect.
•
Macrobipolar may be used for bipolar cutting or rapid coagulation. Voltage is
higher and there is more power than with the bipolar mode.
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Instant Response Technology
Instant Response Technology
Accessories
The accessories that complete the LigaSure vessel sealing system include multiple
reusable and single use instruments for open and laparoscopic procedures. Each
reusable instrument requires a corresponding single use electrode.
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Introduction
The LigaSure generator automatically senses tissue resistance and adjusts the
output voltage to maintain a consistent effect across different tissue density. This
adjustment is based on the power setting and the level of tissue resistance. The
maximum output voltage is controlled to reduce tissue damage and to minimize
sparking.
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Chapter
2
Controls and Receptacles
This section describes the front and rear panels, including all
controls, receptacles, the fuse drawer, and ports.
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Front Panel
Front Panel
Domestic
H
D
B
F
A
C
E
G
E
International
D
H
F
B
A
2-2
C
E
G
E
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Front Panel
These callouts refer to both the domestic and international front panels:
a. Power Switch
•
To turn on the generator, press ( | ).
•
To turn off the generator, press ( O ).
b. Vessel Sealing Receptacle Light
c. Vessel Sealing Instrument Receptacle
d. Regrasp Indicator
e. Standard and IEC Classifications
f.
Bipolar Receptacle Light
g. Bipolar Instrument Receptacle
For details of the vessel sealing and bipolar controls, refer to the following pages
in this section.
Symbol
Indicates
Vessel Sealing
Regrasp
Macrobipolar
Bipolar
Memory
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Controls and Receptacles
h. Memory Button Pressing this button resets the generator to recall prior
intensity and power settings used.
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Front Panel
Vessel Sealing Controls
Domestic
A
International
A
B
B
C
C
D
D
a. Seal RF Activation Light Illuminates with handswitch or footswitch
activation
b. Vessel Sealing Intensity Display Bar graph indicates the relative seal
intensity setting
c. Vessel Sealing Intensity Buttons Press ∆ to increase the intensity.
Press ∇ to decrease the intensity.
d. Regrasp Indicator Illuminates if the tissue is not sealed. This may be
due to:
•
Tissue not responding to RF energy
•
Tissue impedance is out of range
•
The seal cycle was interrupted before the cycle was complete.
•
Maximum seal cycle time has been reached
A pulsed tone sounds and vessel sealing output is disabled.
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Front Panel
Vessel Sealing Instrument Receptacle (purple)
Light
You can only connect a LigaSure vessel sealing instrument to this receptacle.
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Controls and Receptacles
When the instrument is correctly connected, the vessel sealing receptacle light
changes from red to green. The light must be green for the system to operate.
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Front Panel
Bipolar Controls
A
D
Domestic
B
E
C
F
A
D
International
B
E
C
F
a. Macrobipolar RF Activation Light Illuminates gray with handswitch or
footswitch activation
b. Macrobipolar Power Display Shows the power setting in watts for the
macrobipolar mode
c. Macrobipolar Power Buttons Press ∆ to increase the power. Press ∇ to
decrease the power.
d. Bipolar RF Activation Light Illuminates blue with handswitch or
footswitch activation
e. Bipolar Power Buttons Press ∆ to increase the power. Press ∇ to
decrease the power.
f.
2-6
Bipolar Power Display Shows the power setting in watts for the bipolar
mode
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Front Panel
Bipolar Instrument Receptacle (blue)
Light
Smart Connector Adapter
Controls and Receptacles
This receptacle is designed to accept a blue bipolar Valleylab smart connector
adapter. You must use this smart connector adapter to connect any bipolar
instrument.
You can connect either a footswitching (two-pin connector) or handswitching
(three-pin connector) bipolar/macrobipolar instrument to the smart connector.
When the blue bipolar Valleylab smart connector adapter is correctly connected,
the bipolar receptacle light changes from red to green. The light must be green for
the system to operate.
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Rear Panel
Rear Panel
Vessel Sealing Footswitch Receptacle (purple)
Bipolar Footswitch
Receptacle (blue)
Speaker
Volume Knob
To increase the volume, turn
the knob clockwise.
To decrease the volume,
turn it counterclockwise.
Power Entry Module Contains
a fuse drawer, with two fuses,
and a receptacle for connecting
the generator power cord
Handle
Option Panel
Grounding Lug Use
to connect the
generator to earth
ground.
You cannot deactivate the
activation tone or adjust the
regrasp indicator tone
volume.
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Rear Panel
Vessel Sealing Footswitch Receptacle (purple)
Connect either the single pedal vessel sealing footswitch or the two pedal vessel
sealing footswitch to the purple receptacle.
Two Pedal Footswitch
For the LigaSure instrument connected to the vessel sealing instrument receptacle
on the front panel, the connected two pedal footswitch activates either the vessel
sealing output function (round purple pedal) or the bipolar output function (blue
square pedal).
Single Pedal Footswitch
Bipolar Footswitch Receptacle (blue)
Connect the bipolar/macrobipolar footswitch when you connect a bipolar
footswitching instrument to the generator.
Connect the two pedal bipolar footswitch to this receptacle.
The connected footswitch activates bipolar (blue pedal) or macrobipolar (gray
pedal) output for the bipolar instrument that is connected to the bipolar instrument
receptacle on the front panel.
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Controls and Receptacles
For the LigaSure instrument connected to the vessel sealing instrument receptacle
on the front panel, the connected single pedal footswitch activates only the vessel
sealing output function.
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Rear Panel
Option Panel
A removable plate on the rear panel covers a serial port, an RF activation port,
and an expansion port. To review the technical specifications for each port, refer
to Chapter 9.
Serial Port Allows connection of a
computer to the generator to obtain
information using RS-232
communications protocol
RF Activation Port Allows a
connected device to receive
information during RF activation of
the generator, which can then
generate a response in the device
2-10
Expansion Port Allows a
connected device to receive
information about RF output
from the generator
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Chapter
3
Patient and Operating Room Safety
The safe and effective use of the LigaSure system 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 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 versus the benefits of utilizing the LigaSure system in
the procedure.
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General
General
Warning
The LigaSure instruments are intended for use ONLY with the Valleylab LigaSure
vessel sealing system.
If the seal cycle complete tone has not sounded, an optimal seal may not have
been achieved. Reactivate the RF energy until a seal complete tone is heard.
Accidental and unintended burn injury has occurred during procedures in small
surgical fields and on small appendages. See Contact with Metal Objects later in
this chapter for further information on the dangers of contact with metal
instruments.
Use the LigaSure system with caution in the presence of internal or external
pacemakers. Interference produced by the LigaSure generator 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 is planned in patients with cardiac pacemakers.
If the patient has an internal cardiac defibrillator (ICD), contact the ICD
manufacturer for instructions before using the LigaSure system. The LigaSure
system may cause multiple activations of ICDs.
The LigaSure vessel sealing system has not been shown to be effective for tubal
sterilization or tubal coagulation for sterilization procedures. Do not use this
system 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 use the LigaSure system unless properly trained to use it in the specific
procedure being undertaken. Use of this equipment without such training may
result in serious, unintended patient injury.
Always use the lowest output setting in the bipolar/macrobipolar mode to achieve
the desired surgical effect. The higher the current flow and the longer the current
is applied, the greater the possibility of unintended thermal damage to tissue,
especially during use on small structures.
Hazardous Electrical Output This equipment is for use only by trained,
licensed physicians.
Caution
Read all warnings, cautions, and instructions provided with this generator before
using.
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General
Fire/Explosion
Warning
Danger: Explosion Hazard Do not use the LigaSure system in the presence of
flammable anesthetics.
Fire/Explosion Hazard The following substances will contribute to increased
fire and explosion hazards in the operating room:
• Flammable substances (such as alcohol based skin prepping agents and
tinctures)
• Naturally occurring flammable gases that may accumulate in body cavities
such as the bowel
• Oxygen enriched atmospheres
• Oxidizing agents (such as nitrous oxide [N2O] atmospheres)
The sparking and heating associated with electrosurgery can provide an ignition
source. Observe fire precautions at all times. When using electrosurgery in the
same room with any of these substances or gases, prevent their accumulation or
pooling under surgical drapes, or within the area where electrosurgery is
performed.
Fire Hazard with Oxygen Circuit Connections
Warning
Electrosurgical Smoke
Caution
Studies have shown that smoke generated during surgical 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.
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Patient and Operating Room Safety
Fire/Explosion Hazard Verify that all oxygen circuit connections are leak free
before and during the use of electrosurgery. Verify that endotracheal tubes are
leak free, and that the cuff is properly sealed to prevent oxygen leaks. Enriched
oxygen atmospheres may result in fires and burns to patients or to the surgical
team.