User's Guide
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User’s Guide
LigaSure™ Vessel Sealing Generator
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
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
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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
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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
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.
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•
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.
LigaSure User’s Guide
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
LigaSure User’s Guide
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.
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.
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.
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Bipolar Power Display Shows the power setting in watts for the bipolar mode
LigaSure User’s Guide
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.
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.
General
Inadvertent Radiofrequency Burns 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 50-60 Hz, insulated, and/or battery operated.
Ensure Proper Connections Caution Examine all instruments and accessories, and all connections to the LigaSure generator before using. Improper connection may result in arcs, sparks, accessory malfunction, or unintended surgical effects.
Instrument Cords Warning Position instrument cords to avoid contact with the patient or other leads. 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.
Servicing Warning Electric Shock Hazard Do not remove the LigaSure generator cover. Contact authorized personnel for service.
Notice Refer to the LigaSure generator’s service manual for maintenance recommendations and function and output power verification procedures.
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Before Surgery
Before Surgery Active Instruments Warning Electric Shock Hazard Do not connect wet instruments or accessories to the LigaSure generator. Connect instruments to the proper receptacle. Improper connection may result in inadvertent activation or other potentially hazardous conditions. Follow the instructions provided with LigaSure instruments for proper connection and use. Electric Shock Hazard Ensure that all instruments and accessories are dry and correctly connected. Accessory devices connected to the LigaSure generator shall have an insulative rating capable of withstanding a maximum generator output of 380 volts peak. Inspect instruments and cords for breaks, cracks, nicks, or other damage before every use. If damaged, do not use. Failure to observe this caution may result in injury or electrical shock to the patient or surgical team.
Caution Read the instructions, warnings, and cautions provided with LigaSure instruments before using. Specific instructions are not included in this manual.
Generator
Patient Safety Use the generator only if the self-test has been completed as described, or inaccurate power outputs may result. Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. Fire Hazard
Do not use extension cords.
Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment. This is an unstable configuration and does not allow for adequate cooling. When using a smoke evacuator in conjunction with the LigaSure generator, place the smoke evacuator at a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard. Provide as much distance as possible between the LigaSure generator and other electronic equipment (such as monitors). Do not cross or bundle electronic device cords. The LigaSure generator may cause interference with other electronic equipment. A nonfunctioning generator may cause interruption of surgery. A backup generator should be available for use.
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Patient and Operating Room Safety
Warning
During Surgery
Notice If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable. Connect the power cord to a wall receptacle with the correct voltage, or product damage may result.
During Surgery Generator Power Settings Warning Confirm proper power or intensity settings before proceeding with surgery. Use the lowest setting possible in the bipolar/macrobipolar mode that will achieve the desired effect.
Caution LigaSure generators with Instant Response technology work effectively at power and intensity settings lower than other generators. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an instrument is active and energy is being delivered to the tissue. Important Generator output does not automatically stop in the bipolar mode.
Contact with Metal Objects Warning Contact between an active instrument electrode and any metal (hemostats, staples, clips, retractors, etc.) may increase current flow and may result in unintended surgical effects.
Active Accessories Warning Do not activate the generator in the vessel sealing 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. Fire Hazard Do not place LigaSure or bipolar instruments near or in contact with flammable materials (such as gauze or surgical drapes). Instruments that are activated or hot from use may cause a fire. When not in use, place instruments safely away from patients, the surgical team, and flammable materials.
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During Surgery
Caution Do not press both the handswitch and footswitch during the same seal cycle. Generator output will stop and the seal WILL NOT be completed. The seal cycle complete tone will not sound. Energy based devices, such as ESU pencils or ultrasonic scalpels, that are associated with thermal spread should not be used to transect seals.
Laparoscopic LigaSure Instrument Procedures Warning Tissue 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 this instrument on vessels in excess of 7 mm in diameter. 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.
• Carefully insert and withdraw LigaSure instruments from cannulas to avoid possible damage to the devices and/or injury to the patient. Confirm proper LigaSure generator settings before proceeding with surgery. 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. • Clear fluid from the LigaSure instrument jaws prior to activating the instrument.
Open LigaSure Instrument Procedures Warning Tissue 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 this instrument on vessels in excess of 7 mm in diameter.
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Patient and Operating Room Safety
• Do not activate the LigaSure generator 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.
After Surgery
Warning The LigaSure instruments are intended for use ONLY with the Valleylab LigaSure vessel sealing system. Use of these instruments with other Valleylab generators or with generators produced by other manufacturers could result in injury to the patient or surgical team, or cause damage to the instrument. 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. Before installing or removing electrodes, ensure that the instrument cord is not connected to the LigaSure generator and that the generator is OFF or in Standby mode (one orange bar). 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.
Caution Avoid placing fingers in the handle ratchet mechanism. Injury to the user may result.
After Surgery Warning Electric Shock Hazard Always turn off and unplug the generator before cleaning.
Caution Do not reuse or resterilize accessories 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.
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LigaSure User’s Guide
Chapter
4
Before Surgery
This section contains procedures for preparing the generator for surgery. Caution Read all warnings, cautions, and instructions provided with this generator before using. Read the instructions, warnings, and cautions provided with LigaSure instruments and accessories before using.
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Quick Setup Instructions
Quick Setup Instructions If you are familiar with the LigaSure generator, you may prefer to follow this abbreviated procedure. If, however, you are not familiar with the generator setup procedure, detailed instructions follow this section. 1. Plug the generator power cord into the rear panel receptacle. 2. Plug the generator power cord into a grounded wall receptacle. 3. Turn on the generator and verify that the self-test is successfully completed. 4. Prepare for vessel sealing or bipolar applications.
Vessel sealing applications: •
Connect the single pedal or two pedal footswitch to the vessel sealing footswitch receptacle (purple) on the rear panel.
•
Connect a LigaSure instrument to the vessel sealing instrument receptacle (purple) on the front panel.
•
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.
•
Verify or change the intensity setting. (Optional – Press the MEMORY button on the front panel to recall prior intensity and power settings used.)
Bipolar or macrobipolar applications: •
If using a footswitch, connect it to the bipolar footswitch (blue) receptacle on the rear panel.
•
Connect a bipolar instrument to the blue smart connector adapter.
•
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.
•
Verify or change the power settings. (Optional – Press the MEMORY button on the front panel to recall prior intensity and power settings used.)
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LigaSure User’s Guide
Setting Up the Generator
Setting Up the Generator Warning Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. Fire Hazard Do not use extension cords. Patient Safety Use the generator only if the self-test has been completed as described, or inaccurate power outputs may result.
Caution Do not stack equipment on top of the generator or place 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 LigaSure generator and other electronic equipment (such as monitors). Do not cross or bundle electronic device cords. The LigaSure generator may cause interference with other electronic equipment. A nonfunctioning generator may cause interruption of surgery. A backup generator should be available for use. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active and the seal cycle is complete. When using a smoke evacuator in conjunction with the LigaSure generator, place the smoke evacuator at a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard. Notice If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable. Connect the power cord to a wall outlet having the correct voltage. Otherwise product damage may result. 1. Verify the generator is off. 2. Place the generator on a stable flat surface, such as a table, platform, or
Valleylab cart. Carts with conductive wheels are recommended. For details, refer to the procedures for your institution or to local codes.
3. Plug the generator power cord into the rear panel receptacle. 4. Plug the generator power cord into a grounded receptacle.
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Before Surgery
Provide at least four to six inches of space around the sides and top of the generator for cooling. Normally, the top, sides, and rear panel are warm when the generator is used continuously for extended periods of time.
Preparing for Surgery
5. Turn on the generator by pressing the power switch on ( | ). Verify the
following: •
All visual indicators and displays on the front panel illuminate.
•
Activation tones sound to verify that the speaker is working properly.
If the self-test is successful: •
Two tones sound.
•
The bipolar and macrobipolar power displays show a setting of 1.
•
The vessel sealing intensity display shows a setting of one orange bar.
If the self-test is not successful: •
An alarm tone sounds.
•
RF output is disabled.
•
“E” and a single number flash in the macrobipolar power display and two numbers flash in the bipolar power display. Note the number and refer to Responding to System Alarms in Chapter 7.
Once the self-test is successful, connect the accessories and set the generator controls.
Preparing for Surgery Warning Electric Shock Hazard • Do not connect wet instruments or accessories to the LigaSure generator. • Ensure that all instruments and adapters are dry and correctly connected and that no metal is exposed at plug or connectors. • Instruments and adapters connected to the LigaSure generator shall have an insulative rating capable of withstanding a maximum generator output of 380 volts peak.
Caution Read the instructions, warnings, and cautions provided with LigaSure instruments before using. Specific instructions are not included in this manual. Inspect instruments and cords (especially reusable instruments and cords) for breaks, cracks, nicks, or other damage before every use. If damaged, do not use. Damage may result in injury or electrical shock to the patient or surgical team.
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Preparing for Surgery
Footswitch Connections Connect the appropriate footswitch to the corresponding receptacle on the rear panel.
Bipolar Footswitch Receptacle (blue)
Vessel Sealing Footswitch Receptacle (purple)
Instrument Connections The LigaSure system can be used in several different configurations: •
With only a vessel sealing instrument attached to the LigaSure receptacle (purple)
•
With only a bipolar instrument attached to the bipolar instrument receptacle (blue)
•
With both a vessel sealing instrument and a bipolar instrument attached to their respective receptacles (simultaneous activation is not available)
The instrument connected to the LigaSure instrument receptacle can be activated in either the vessel sealing mode (using the single-pedal or two-pedal footswitch) or standard bipolar mode (using the two-pedal blue and grey footswitch). However, the instrument connected to the bipolar instrument receptacle can only be activated in the bipolar and macrobipolar modes using the two-pedal footswitch.
Vessel Sealing Instrument Connection 1. Prepare the reusable LigaSure instruments to be used for the procedure. a. Slip the base of the white shaft of the electrode onto the instrument ring
handle with the retaining post. b. Snap the body of the electrode shaft onto the instrument handle. The white
shaft of the electrode must be completely flush on the reusable instrument shaft. c. Snap each electrode into the appropriate instrument jaw, matching
electrode curvature to jaw curvature. Insert the proximal pin first. Verify that there is no gap between the electrode and the instrument jaw.
d. Gently ratchet the instrument closed on a folded 4x4 to ensure the
electrodes are properly seated in the instrument jaws.
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Before Surgery
Note: Bent or broken electrode pins will not function properly and must be discarded.
Preparing for Surgery
2. Connect all LigaSure instruments (reusable and single use). a. Connect the instrument to the vessel sealing receptacle on the front panel. b. Verify that the receptacle indicator illuminates from red to green to
confirm a proper connection to the generator. Light
Set the Output for the Vessel Sealing Mode 1. (Optional) Press the MEMORY button to recall prior intensity settings used. 2. Set the vessel sealing intensity.
In the vessel sealing mode, the sealing intensity level changes in 1 light bar increments, with a range of 1 to 5 bars. Increasing the intensity increases the total energy delivered to the tissue for the duration of the seal cycle. To increase the intensity , press the UP ( ∆ ) button. To decrease the intensity, press the DOWN ( ∇ ) button. 3. The instrument connected to the LigaSure instrument receptacle is activated
utilizing the LigaSure footswitch.
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Preparing for Surgery
Bipolar Instrument Connection 1. Connect the bipolar instrument to the bipolar instrument receptacle on the
front panel using the blue bipolar smart connector adapter. 2. Verify that the receptacle indicator illuminates green to confirm a proper
connection. Light
Set the Output for the Bipolar Mode 1. (Optional) Press the MEMORY button to recall prior power settings used. 2. Set the bipolar or macrobipolar output power.
In the bipolar or macrobipolar modes, the power level changes numerically, in 1 watt increments from 1 to 40, and in 5 watt increments from 40 to 95. To increase the power, press the UP ( ∆ ) button. To decrease the power, press the DOWN ( ∇ ) button. 3. The instrument connected to the Bipolar instrument receptacle can only be
activated in the bipolar and macrobipolar modes using the bipolar footpedal.
Before Surgery
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Chapter
5
During Surgery
This section covers the following topics: • Checking accessory connections • Changing the power or intensity setting • Activating the surgical instrument • Adjusting the volume of activation tones • Responding to alarms
Caution Read all warnings, cautions, and instructions provided with this generator before using. Read the instructions, warnings, and cautions provided with LigaSure instruments before using. Specific instructions are not included in this manual.
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Checking Accessory Connections
Checking Accessory Connections Warning Do not wrap instrument cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.
Caution Examine all instruments and accessories and all connections to the LigaSure generator before using. Improper connection may result in arcs, sparks, accessory malfunction, or unintended surgical effects.
Verify that all accessories are properly connected to the generator. When multiple accessories are used, keep cords separate. To reduce cross coupling, do not twist, bundle, or clamp cords together.
Changing the Power or Intensity Setting Warning Confirm proper power or intensity settings before proceeding with surgery. In the bipolar/macrobipolar mode use the lowest setting that will achieve the desired surgical effect.
Caution LigaSure generators with Instant Response technology work effectively at power and intensity settings lower than other generators.
Vessel Sealing Increase the intensity: Press the Up ( ∆ ) button for the selected mode. Decrease the intensity: Press the Down ( ∇ ) button for the selected mode. When you press and release the intensity button, the sealing intensity changes by one green light bar. The optimal setting for the LigaSure system instruments is two to three green bars. Increasing the intensity increases the total energy delivered to the tissue for the duration of the seal cycle. You cannot change the setting during activation.
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Activating the Surgical Instrument
Bipolar or Macrobipolar
To reach the maximum or minimum power setting for the selected mode, press and hold the Up ( ∆ ) or Down ( ∇ ) button. The setting changes slowly at first, then more rapidly. Release the button when the desired setting is displayed.
Activating the Surgical Instrument Warning Do not activate the generator in the vessel sealing mode until the vessel sealing instrument has been applied with the proper pressure. Activating the generator before this is done may result in an improper seal and may increase thermal spread to tissue outside the surgical site. 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. Use the bipolar/macrobipolar mode only until you achieve the desired surgical effect in order to minimize the possibility of burns. This is especially true in pediatric and neonatal patients or in any patient where small appendages are involved. The LigaSure generator does not automatically shut off in bipolar/ macrobipolar mode.
Caution Do not press both the handswitch and footswitch during the same seal cycle. Generator output will stop and the seal WILL NOT be completed. The seal cycle complete tone will not sound.
To activate the generator: •
Press the pedal on the footswitch, or
•
Activate the handswitch if the instrument has one
Vessel Sealing When you activate the generator for vessel sealing, the corresponding indicator illuminates blue and a continuous tone sounds to indicate the presence of RF output. Keep your foot on the pedal or your finger on the handswitch until you hear a short tone. The tone indicates that RF output is disabled and the seal cycle is complete. Bipolar The generator does not automatically shut off when using the bipolar mode.
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During Surgery
When you press and release the power button, the power changes in 1 watt increments between 1 and 40, and in 5 watt increments between 40 and 95. Each time you press the power button while the generator is activated, the power changes by one setting only to prevent rapid changes in power delivered to the surgical site.
Activating the Surgical Instrument
Regrasp Indicator When using the vessel sealing mode, the 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 RF output is disabled. If the Regrasp indicator illuminates and four pulsed tones sound while sealing, RF current is automatically discontinued. You should: 1. Release the footswitch pedal. 2. Open the jaws and inspect the tissue for a successful seal. Repeat the
procedure if necessary. Possible Regrasp indicator conditions Instant Regrasp Indicator
Open circuit/High impedance detection – Regrasp tissue and repeat procedure. If an instantaneous Regrasp condition continues, replace the instrument. Delayed Regrasp Indicator
Pooled fluids around the instrument tip – Minimize fluids. Inspect the tissue for a successful seal and repeat the procedure if necessary. Thin tissue – 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. Grasping metal object – Avoid grasping metal objects, such as staples or clips, in the jaws of the instrument. Interrupted Seal Cycle Regrasp
No end tone sounded – •
The footswitch or handswitch was released before the seal cycle was complete.
•
The generator has detected removal of the instrument plug from the front panel connector.
•
The generator has detected a problem with the plug/generator interface. Verify that the instrument connector is fully inserted into the front panel receptacle and the indicator is illuminated green.
The generator needs more time and energy to complete the seal. Reactivate the seal cycle without removing or repositioning the clamp.
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Adjusting the Volume of Activation Tones
Time Out Reseal Indicator
Maximum seal cycle time has been reached – The generator needs more time and energy to complete the seal. Reactivate the seal cycle without removing or repositioning the clamp.
Adjusting the Volume of Activation Tones Caution Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an instrument is active and energy is being delivered to the tissue.
To change the volume of activation tones, turn the Volume knob on the rear panel: •
Clockwise, to increase the volume
•
Counterclockwise, to decrease the volume
You cannot silence the activation tones.
Responding to Alarms When the generator senses a system malfunction condition, an alarm tone sounds and the generator is deactivated. “E” and a single number flash in the macrobipolar power display and two numbers flash in the bipolar power display. 1. Turn off the generator. 2. Turn on the generator and verify that the self-test is completed successfully. If
the error code number reappears, note the number and refer to Responding to System Malfunctions in Chapter 7. If you are unable to correct the system malfunction condition, use a backup generator or traditional hemostatic techniques to complete the surgical procedure.
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During Surgery
You may also choose to continue the procedure using traditional hemostatic techniques or bipolar current. Set the Bipolar power level on the front panel of the generator as described earlier in this section. Grasp the tissue in the jaws but do not latch the handle in the locked position. Step on the square (blue) bipolar pedal of the vessel sealing footswitch. Release the pedal when done.
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Chapter
6
After Surgery
This section instructs you on: • Preparing the generator for reuse • Reprocessing instruments • Storing the generator
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Preparing the Generator for Reuse
Preparing the Generator for Reuse 6
Caution Do not reuse or resterilize instruments or accessories labeled “disposable” or “single use only.”
Disconnect the Accessories 1. Turn off the generator. 2. Disconnect all accessories from the front panel.
•
If the accessory is single use only (disposable), dispose of it according to the procedures for your institution.
•
If the accessory is reusable, clean and sterilize it according to the manufacturer’s instructions.
•
Do not dispose of the blue bipolar smart connector adapter.
3. Disconnect and store any footswitch(es) used.
Clean the Generator 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. 1. Turn off the generator, and unplug the power cord from the wall outlet. 2. Thoroughly wipe all surfaces of the generator and power cord with a mild
cleaning solution or disinfectant and a damp cloth. Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the chassis.
Reprocessing Instruments Clean the Reusable Instrument 1. Remove and dispose of single use electrodes. 2. Wipe all surfaces with a cleaning agent and a damp cloth. 3. Follow the procedures approved by your healthcare facility.
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Storing the Generator
4. Soak in an enzymatic cleaning agent, such as Klenzyme or Enzol, according
to the manufacturer’s instructions. 5. Scrub all surfaces with a soft brush. It is important that the jaw surfaces and
instrument electrode holes are cleaned of blood and tissue to ensure proper electrode assembly. 6. Rinse with water and dry with a soft cloth
Sterilization Parameters The reusable instrument hinges are extremely tight and require additional flash sterilization times to ensure steam penetration into the hinge. Unwrapped (Flash) for a pre-vac autoclave system: 132° C (270° F) for 10 minutes Unwrapped (Flash) for a gravity autoclave system: 132° C (270° F) for 15 minutes
After Surgery
Wrapped pre-vac autoclave system: 132° C (270° F) for 10 minutes Use the standard hospital dry cycle Wrapped for a gravity autoclave system: 132° C (270° F) for 15 minutes Use the standard hospital dry cycle Wrapped for a gravity autoclave system: 121° C (250° F) for 30 minutes Use the standard hospital dry cycle
Storing the Generator If the generator is stored at a temperature outside its normal operating range of 10° to 40° C (50° to 104° F), allow it to sit at room temperature for one hour prior to use. The generator can be stored indefinitely. However, if you store it longer than one year, you must perform specific checkout procedures before use (refer to the service manual).
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Chapter
7
Troubleshooting
This section includes the following information: • Correcting malfunctions • Responding to system alarms
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General Troubleshooting Guidelines
General Troubleshooting Guidelines If the generator malfunctions, check for obvious conditions that may have caused the problem: •
Check the generator for visible signs of physical damage.
•
Make sure the fuse drawer is tightly closed.
•
Verify that all cords are connected and attached properly.
•
If an error code is displayed, turn the generator off, then on again.
If the malfunction persists, the generator may require service. Contact your institution’s Biomedical Engineering Department.
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