stryker LF2019 Remanufactured LigaSure Exact Dissector Owner’s Manual

: May 15, 2024
: stryker

stryker LF2019 Remanufactured LigaSure Exact Dissector Owner’s Manual

Remanufactured device for single use

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

STERILE
Exposed to Ethylene Oxide (EO) gas

LF2019 Compatible with: VLFT10GEN SW v1.1 – v4.0.2.25

Explanation of symbols

Symbol| Rules/ Standard Reference| ISO 7000 Registration Number| Symbol Title| Description
---|---|---|---|---
| ISO 15223-1:2016| 2501| Sterilized using ethylene oxide| Indicates a medical device that has been sterilized using ethylene oxide.
| ISO 15223-1:2016| 2497| Date of manufacture| Indicates the date when the medical device was manufactured.
| ISO 15223-1:2016| 2607| Use-by date| Indicates the date after which the medical device is not to be used
| ISO 15223-1:2016| 2493| Catalogue number| Indicates the manufacturer’s catalogue number so that the medical device can be identified.
| ISO 15223-1:2016| 2492| Batch code| Indicates the manufacturer’s batch code so that the batch or lot can be identified.
| ISO 15223-1:2016| 1641| Consult instructions for use| Indicates the need for the user to consult the instructions for use.
| ISO 15223-1:2016| 1051| Do not re-use| Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
| ISO 15223-1:2016| 2608| Do not desterilize| Indicates a medical device that is not to be desterilized.
| ISO 15223-1:2016| 2606| Do not use if package is damaged| Indicates a medical device that should not be used if the package has been damaged or opened.
| ISO6 15223-1:2016| 0626| Keep dry| Indicates a medical device that needs to be protected from moisture.
| ISO 7000:2019| 3010| Contains RFID tag| Indicates the presence of the RFID tag incorporated within the packaging, container, or equipment without identifying the specific air interface or data structure employed.

Remanufactured Liga Sure Exact Dissector Without Nano-coating description

The LF2019 is designed for use with Covidien electrosurgical generators that include vessel sealing capability. Please refer to the cover page for details on compatible generator models and software versions. If the software version on your generator is lower than required, contact Covidien about software updates.

These instructions assume that the operator is knowledgeable about correct set-up and operation of the associated Covidien generator. Refer to the generator user’s guide for set up information and for additional warnings and cautions.

The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. A cutting blade within the instrument is surgeon-activated to divide tissue.

Maximum rated voltage: 288 Peak

Not made with natural rubber latex
Do not use if package is opened or damaged Type CF applied part

Indications for use

The Remanufactured Liga Sure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The Liga Sure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nyssen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The Liga Sure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the Liga Sure system for these procedures.

Contraindications for use

The Liga Sure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the Liga Sure system for these procedures.

Warnings
This product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse and is therefore intended for single use. Attempts to clean or sterilize these devices without appropriate regulatory authorization may result in bio-incompatibility, infection, or product failure risks to the patient.

This instrument is intended for use ONLY with the Covidien equipment listed on the cover of this document. Use of this instrument with other generators may not result in the desired tissue effect, may result in injury to the patient or surgical team, or may cause damage to the instrument.

Do not use the Liga Sure 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.

Use the system with caution in the presence of internal or external pacemakers or other implanted devices. Interference produced by electrosurgical equipment can cause a pacemaker or other device to enter an unsafe mode or permanently damage the device. Consult the device manufacturer or responsible hospital department for further information when use is planned in patients with implanted medical devices.

Contact between an active instrument electrode and any metal object (hemostats, staples, clips, retractors, etc.) may increase current flow and may result in unintended surgical effects, such as an effect at an unintended site or insufficient energy deposition.

The safe and effect use of RF energy depends on many factors solely under the control of the operator. There is no substitute for properly trained and vigilant personnel. It is important that the operating instructions supplied with this or any other medical equipment be read, understood, and followed.

Precautions

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.
Precautions

Jaws (gray)
Ring handles (gray)
Hand-activation button (purple)
Cutting triggers (gray), one on each side (arrow shows direction for cutting)
Cable/cord
Connector (purple and white)

The nanocoating featured on the original device is not present on this product.

Adjunctive use of nerve-monitoring device is recommended during nerve-sparing procedures such as thyroidectomies, radical neck dissection and parotidectomies.

Secondary hemorrhaging after tonsillectomy is a potentially serious adverse event. According to some reports, electrosurgical devices may be associated with a small increase in the incidence of secondary post tonsillectomy hemorrhaging

Set-up Warning
Electric Shock Hazard – Do not connect wet accessories to the Liga Sure system.

Position instrument cords to avoid contact with the patient or other cords. Do not wrap cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.

Examine all Liga Sure system and instrument connections before using. Improper connections may result in arcing, sparks, accessory malfunction, or unintended surgical effects.

Inspect the instrument and cords for breaks, cracks, nicks, or other damage before use. Failure to observe this caution may result in injury or electrical shock to the patient or surgical team or cause damage to the instrument. If damaged, do not use.

Confirm proper Liga Sure system settings before proceeding with surgery.

Do not use in the presence of flammable anesthetics or oxidizing gases, such as nitrous oxide (N2O) and oxygen, or in close proximity to volatile solvents (such as ether or alcohol) as explosion may occur.

Because of concerns about the carcinogenic and infectious potential of electrosurgical by-products (such as tissue smoke plume and aerosols), protective eye wear, filtration masks, and effective smoke evacuation equipment should be used.

Connect adaptors and accessories to the electrosurgical unit only when the unit is off or in standby mode. Failure to do so may result in injury or electrical shock to the patient or operating personnel.

Precaution

Inspect packaging for damage. If damaged, do not use.

If the generator provides multiple power settings, use the lowest power needed to achieve the intended effect.

Open the pouch, remove the device and the card from the pouch.
Insert the connector (6) of the Liga Sure Sealer/Divider into the Liga Sure instrument port of the generator.
Refer to the generator user’s guide for additional set up information.

During Surgery

The Liga Sure Sealer/Divider can be used during surgery both to manipulate and dissect tissue, and to seal and cut vessels and tissue bundles. Instructs for use of the instrument during a procedure are provided in this section.

Warning
Avoid placing fingers between the jaws or ring handles. Injury to the use may result.

Use caution when handling the instrument between uses to avoid accidental activation of the LigaSure system. Do not place the instrument on the patient or drapes when not in use.

Keep the cable free from between the jaws and ring handles of the instrument.

Fire Hazard – Do not place instruments near or in contact with flammable materials (such as gauze, surgical drapes, or flammable gases). Instruments that are activated or hot from use may cause a fire. When not using instruments, place them in a clean, dry, highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns.

Precaution

Do not use the Liga Sure Sealer/Divider as bipolar scissors. Continual activation to separate tissue promotes eschar buildup on seal surfaces that can reduce the effectiveness of the seal, and may create a condition that compromises the jaw’s insulating coating.

Tissue Manipulation and Dissection

The instrument can be used to manipulate and dissect tissue with the jaws either open or closed.

Sealing Vessels and Tissue Bundles Warning

Prior to sealing or manipulating tissue, ensure that the cutting blade is not exposed.

Do not use this instrument on vessels larger than 7 mm in diameter.

Do not place the vessel and/or tissue in the jaw hinge. Placed the vessel and/or tissue in the center of the jaws.

Do not divide tissue before the seal cycle is complete as this may result in improper sealing.

Do not pull the cutting trigger while the jaws are open as injury to the patient or surgical team may occur.

Conductive fluids (e.g., blood or saline) in direct contact with or in close proximity to the instrument may carry electrical current or heat, which may cause unintended burns to the patient. Aspirate fluid from around the instrument jaws before activating the instrument.

Keep the external surface of the instrument jaws away from adjacent tissue while activating the Liga Sure system or unintended injury may result.

During a seal cycle, energy is applied to the tissue between the instrument jaws. This energy may cause water to be converted into steam. The thermal energy of steam may cause unintended injury to tissues in close proximity to the jaws. Care should be taken in surgical procedures occurring in confined spaces in anticipation of this possibility.

Use caution when grasping, manipulating, sealing, and dividing large tissue bundles.

Do not attempt to seal or cut over clips or staples as incomplete seals/damage to the cutting blade will occur. Contact between an active electrode and any metal objects may result in alternate site burns or incomplete seals.

The surfaces of the jaws may remain hot enough to cause burns after the RF current is deactivated.

Inadvertent activation or movement of the activated instrument outside of the field of vision may result in injury to the patient or surgical team.

Do not activate the LigaSure system in an open-circuit condition. Activate the system only when the instrument is in direct contact with the target tissue to lessen the possibility of unintended burns.

Do not activate the instrument while 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.

Eliminate tension on the tissue when sealing and cutting to ensure proper function and reduce bleeding.

Precaution
When intending only to grasp or manipulate tissue, ensure pressure to the ring handles does not cause the second click that activates energy delivery.

Keep the instrument jaws clean. Build-up of eschar may reduce the seal and/or cutting effectiveness. Wipe jaw surfaces and edges with a wet gauze pad as needed.

Do not overfill the jaws of the instrument with tissue, as this may reduce device performance.

Hand Activation

Notice
Closing the ring handles to the second click activates or reactivates energy delivery if hand-activation is being used.

Ensure hand-activation is enabled on the appropriate port. Refer to the generator user’s guide if needed.
Grasp the intended vessel and/or tissue in the center of the jaws.
Close the ring handles until you hear or feel two clicks. At the second click, energy is delivered.
A continuous tone sounds to indicate the activation of RF energy. When the activation cycle is complete, a tousled Seal-Cycle-Complete tone sounds and RF output ceases.
Notice
The surgeon may inspect the seal before cutting the vessel or tissue. After inspecting the seal, the surgeon should create a second seal adjacent to the first seal before cutting, as described below.
A tone with multiple pulses indicates that the seal cycle was not completed. Refer to the Troubleshooting section for possible causes and corrective actions. Do not cut tissue until you have verified that there is an adequate seal.
To seal adjacent tissue, overlap the edge of the existing seal. The second seal should be distal to the first seal to increase seal margin.

Footswitch Activation

A footswitch can be used instead of the hand-activation button (3). Ensure that the footswitch is connected to the footswitch receptacle that corresponds to the instrument receptacle in use.

Warning
Activating energy delivery with a footswitch when the hand-activation button is not in the second-click position may result in improper sealing and increase thermal spread to tissue outside the surgical site. The second click of the hand-activation button indicates proper pressure is being applied to the tissue.

Connect the footswitch to the generator as described in the generator user’s guide.
Ensure hand-activation is disabled on the appropriate port. Refer to the generator user’s guide if needed.
Grasp the intended vessel and/or tissue in the center of the jaws.
Press and hold ring handles to the second click to ensure appropriate pressure on the grasped tissue.
Press and hold the footswitch pedal to activate energy.

A continuous tone sounds to indicate the activation of RF energy. When the activation cycle is complete, atwo pulsed Seal-Cycle-Complete tone sounds and RF output ceases.

Notice
The surgeon may inspect the seal before cutting the vessel or tissue. After inspecting the seal, the surgeon should create a second seal adjacent to the first seal before cutting, as described below.

A tone with multiple pulses indicates that the seal cycle was not completed. Refer to the Troubleshooting section for possible causes and corrective actions. Do not cut tissue until you have verified that there is an adequate seal.

To seal adjacent tissue, overlap the edge of the existing seal. The second seal should be distal to the first seal to increase seal margin.

Cutting Tissue Warning
Energy-based devices, such as ES pencils or ultrasonic scalpels that are associated with thermal spread, should not be used to transect seals.

Notice
Failure to maintain steady pressure on the ring handles while cutting could result in inadvertent reactivation of energy.

To divide tissue, maintain steady pressure on the ring handles and pull the cutting trigger (4) until a hard stop is reached. Then release the cutting trigger to allow the cutting blade to retract.
Open the jaws to release tissue.

Cleaning the Instrument During Use Warning

Inspect the instrument jaws prior to cleaning to ensure the cutting blade is not deployed.

Do not activate the instrument or cutting trigger while cleaning the jaws. Injury to operating room personnel may result.

Wipe jaw surfaces and edges with a wet gauze pad as needed.

Notice
Do not attempt to clean the instrument jaws by activating the instrument on wet gauze. Product damage may occur.

Remove any embedded tissue from blade track and jaw hinge area.

Do not clean the instrument jaws with a scratch pad or other abrasives.

Troubleshooting

The following is a list of troubleshooting suggestions for situations encountered when using the instrument with compatible Covidien vessel sealing generators. For details on specific situations, refer to the corresponding generator user’s guide or the generator quick reference guide.

Alert Situations
When an alert condition occurs, energy delivery stops. After the alert condition has been corrected, energy delivery will be immediately available.

Troubleshooting Information

The following is a list of troubleshooting suggestions for situations encountered when using the instrument with compatible Covidien vessel sealing generators. For details on specific situations, refer to the corresponding generator user’s guide or the generator quick reference guide.
Alert situations| When an alert condition occurs, energy delivery stops, the generator produces a sequence of pulsed tones, and an alert will be displayed on the generator.
Do Not Cut the Vessel. The user should inspect the seal site and instrument before proceeding. After the alert condition has been corrected, energy delivery will be immediately available.
Troubleshooting steps|

Release the footswitch pedal or activation button, if still engaged.
Open the instrument jaws and inspect for a successful seal.
Follow the suggested corrective actions on the generator screen, the generator quick reference card, or in the generator user’s guide.
If possible, reposition the instrument and regrips tissue in a location that overlaps the previous seal, then reactivate the seal cycle.

Reasons for alert| Too little tissue between the jaws – The user is grasping thin tissue or not enough tissue; open the jaws and confirm that a sufficient amount of tissue is inside the jaws. If necessary, increase the thickness of the tissue that is grasped and reactivate the seal cycle.
Too much tissue between the jaws – The user is grasping too much tissue; open the jaws, reduce the amount of tissue tat is grasped, and reactivate the seal cycle.
Activating on a metal object – Avoid grasping objects, such as staples, clips, or encapsulated sutures in the jaws of the instrument.
Dirty jaws – Use a wet gauze pad to clean surfaces and edges of instrument jaws.
| Excess fluids in the surgical field – Minimize or remove excess fluids from around the instrument jaws.
Activation switch release before seal complete tone – The footswitch or activation button was released before the seal cycle was complete .
Maximum seal cycle time has been reached – The system needs more time and energy to complete the seal cycle.

After Surgery

Discard the instrument after use according to the facility’s policy for biohazards and sharps. Do not desterilize.

Pre-Clinical Studies Notice

There is no animal data qualified to predict the effectiveness of this device in sealing vessels containing
atherosclerotic plaque.

Product performance of the device was established in a chronic in-vivo porcine model. The results showed that no animals studied experienced an hemostatic complications related to the device during the 21-day survival period. A variety of tissue types and vessels was evaluated to demonstrate effective sealing in arteries and veins up to and including 7 mm. The United States clearance of this device was nor based on human clinical testing.

In Vivo Vessel Performance (Chronic)

Standards and IEC Classifications

The Remanufactured Liga Sure Exact Dissector Without Nano-coating meets all pertinent clauses of IEC 60601-1 Edition 3+A1;C1, IEC 60601-1-2, and IEC 60601-2-2 Edition 6.0.

If the Remanufactured LigaSure Exact Dissector Without Nano-coating experience loss or degradation of the essential performance described in these instructions as a result of EMC disturbances, there would be no effect to intended use.

The medical device is suitable to be used in the Professional Healthcare Facility Environment.

Environmental Parameters

Operation and Storage

Ambient Temperature Range| 10 to 40 °C (50 to 104 °F)
Relative Humidity| 15% to 90% non-condensing
Transport
Ambient Temperature Range| -20 to 60 °C (-4 to 140 °F)
Relative Humidity| 15% to 90% non-condensing

Warranty

Remanufactured products
Stryker warrants all remanufactured products, subject to the exceptions provided herein, to be free from defects in remanufacturing and to substantially conform to the product specifications contained in the documentation provided by Stryker with the products for one use in accordance with the instructions for use of such product.

Products for which Stryker is the original manufacturer
Stryker warrants all products for which it is the original manufacturer, subject to the exceptions provided herein, to be free from defects in design, materials and workmanship and to substantially conform to the product specifications contained in the documentation provided by Stryker with the products for a period of one year from the date of purchase.

General warranty terms applicable to all products To the fullest extent permitted by law, the express warranty set forth herein is the only warranty applicable to the products and is expressly in lieu of any other warranty by Stryker, expressed or implied, including, but not limited to, any implied warranty or merchantability or fitness for a particular purpose. In no event will Stryker’s liability arising in connection with the sale of the product (whether under the theories of breach of contract, tort, misrepresentation, fraud, warranty, negligence, strict liability or any other theory of law) exceed the purchase price, current market value or residual value of the products, whichever is less. Stryker shall not be liable for indirect, special, incidental, punitive, or consequential damages resulting from any breach of warranty or under any other legal theory.

This warranty shall apply only to the original end-user purchaser of products directly from Stryker or a Stryker authorized distributor. This warranty may not be transferred or assigned without the express written consent of Stryker.

This warranty does not apply to: (1) products that have been misused, neglected, modified, altered, adjusted, tampered with, improperly installed or refurbished; (2) products that have been repaired by any person other than Stryker personnel without the prior written consent of Stryker; (3) products that have been subjected to unusual stress or have not been maintained in accordance with the instructions in the user manual or as demonstrated by a Stryker representative; (4) products on which any original serial numbers or other identification marks have been removed or destroyed; or (5) products that have been repaired with any unauthorized or non-Stryker components.

If a valid warranty claim is received within thirty (30) days of the expiration of the applicable warranty period, Stryker will, in its sole discretion: (1) replace the product at no charge with a product that is at least functionally equivalent to the original product or (2) refund the purchase price of the product. If a refund is provided by Stryker, the product for which the refund is provided must be returned to Stryker and will become Stryker’s property. In any event, Stryker’s liability for breach of warranty shall be limited to the replacement value of the defective or non conforming part or component.

If Stryker determines in its reasonable discretion that the claimed defect or non-conformance in the product is excluded from warranty coverage as described hereunder, it will notify the customer of such determination and will provide an estimate of the cost of repair of the product. In such an event, any repair would be performed at Stryker’s standard rates.

Products and product components repaired or replaced under this warranty continue to be warranted as described herein during the initial applicable warranty period or, if the initial warranty period has expired by the time the product is repaired or replaced, for thirty (30) days after delivery of the repaired or replaced product. When a product or component is replaced, the item provided in replacement will be the customer’s property and the replaced item will be Stryker’s property. If a refund is provided by Stryker, the product for which the refund is provided must be returned to Stryker and will become Stryker’s property.

The OEM information listed on the label is provided as device ID prior to reprocessing and may contain the trademarks of unrelated third parties that do not sponsor this device.

Sterilization: This product and its packaging have been sterilized with ethylene oxide gas (EtO). Even though the product then is processed in compliance with all applicable laws and regulations relating to EtO exposure, Proposition 65, a State of California voter initiative, requires the following notice:

Warning: This product and its packaging have been sterilized with ethylene oxide. The packaging may expose you to ethylene oxide, a chemical known to the State of California to cause cancer or birth defects or other reproductive harm.

Covidien™ is a registered trademark of Covidien AG. Force Triad™ and Liga Sure™ are trademarks of a Covidien company. All other trademarks, registered trademarks, and product names are the property of their respective owners.
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