Vessel Sealer Extend Instruments and Accessories User Manual Addendum Rev A

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Copyright ©2021–2023 Intuitive Surgical, Inc. All rights reserved.

Trademarks Intuitive, da Vinci, da Vinci Xi, and da Vinci X are trademarks or registered trademarks of Intuitive Surgical, Inc. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner. See www.intuitive.com/trademarks.

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Contents 1 Introduction... 5 1.1 Contact Information...5 About this Manual... 6 1.2 Compliance and Classifications...6 Compliance and Classification... 6 1.3 Indications for Use...6 1.4 Performance Data...6 1.5 Compatibility Information...7 1.6 Device Description...7 Sealing... 8 Cutting... 9 1.7 General Warnings and Cautions... 10 Vessel Sealer Extend Overview... 12 Avoiding, Identifying and Resolving Adverse Electromagnetic Effects... 12

2 Preparation and Use... 13 2.1 Open Packaging... 13 2.2 Inspection... 13 2.3 Preparation and Installation... 13 2.4 Intraoperative Use... 16 Precautions for Intraoperative Use... 16 Overview: Seal and Cut... 18 Instructions for Intraoperative Use... 19 Intraoperative Cleaning... 22 2.5 Instrument Removal... 23 2.6 Instrument Disposal... 23

3 Troubleshooting... 25 3.1 Blade Exposed... 25 3.2 Connection Faults... 26 Vessel Sealer Extend not connected to VIO dV... 26 VIO dV not Powered On... 27 3.3 Incomplete Sealing Cycle... 27 3.4 Close Grips to Enable Cutting... 27 3.5 SmartCut: Target Tissue Too Thick... 28 3.6 Applying Energy or Cutting in a Faulted State... 28 3.7 Mid-Procedure Restart... 28 3.8 Other Instrument Problems... 29 3.9 Grip Release... 29

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4 4 Symbols and Icons Reference Table... 32 5 Sterilization Methods... 33 6 Natural Rubber Latex... 34

Da Vinci Energy | Vessel Sealer Extend

Introduction

1 Introduction This document provides details specific to the Vessel Sealer Extend instrument (referred to in this document as Vessel Sealer Extend or the instrument). Vessel Sealer Extend is designed to be used with a compatible da Vinci surgical system and the ERBE VIO dV electrosurgical generator (VIO dV). This document provides instructions to use the Vessel Sealer Extend in conjunction with the VIO dV. It is not a reference for surgical techniques. Refer to the applicable system user manual for full system information and warnings. Refer to the VIO dV User Manual for full generator information, warnings, and troubleshooting. Failure to properly follow all instructions, including instructions supplied with the da Vinci system and VIO dV may lead to injury and result in improper functioning of the device. WARNING:

DO NOT RE-STERILIZE.

DO NOT RE-USE.

Reprocessing or reuse of products intended for single use may result in infection. WARNING:

Do not use if package is damaged.

A breach in the sterile packaging of the device indicates possible contamination. Do not use the device if the packaging is not intact. Note: The Vessel Sealer Extend instrument ships sterile and is for single use only. It is not designed to be cleaned, disinfected, or sterilized. Therefore, validated cleaning and sterilization methods and instructions are not available for this product. Note: All system components must be installed by Intuitive Surgical personnel.

1.1 Contact Information For Customer Service and Reporting of Complaints or Adverse Events Use the following information for customer service, including ordering, reporting complaints or adverse events, and general information regarding Intuitive Surgical or our products and services.

In the U.S.

In Europe

Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA Toll free: 1.800.876.1310 Direct: 408.523.2100 Fax: 408.523.2377

Intuitive Surgical SAS 11 avenue de Canteranne 33600 Pessac, France Toll free: +800.0821.2020 Direct: +33.1.77.68.88.45 Fax: +800.0821.2021 or +41.21.821.2021

For Technical Support If the system requires maintenance or service, call our Technical Support line. In the US, call 1.800.876.1310, where phones are staffed 24 hours a day, seven days a week. In Europe, call +33.1.77.68.88.45.

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Introduction Manufacturer Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA www.intuitive.com

Intuitive Surgical SAS 11 avenue de Canteranne 33600 Pessac, France

About this Manual This manual presents representative illustrations and system images as examples of the Vessel Sealer Extend instrument. The representative images provide instruction on the use of the products and apply to the Vessel Sealer Extend instrument. In some cases, the aesthetics or length of the device shown in the representative images may be different from the product in use.

1.2 Compliance and Classifications Compliance and Classification

2460

Intuitive Surgical da Vinci Vessel Sealer Extend is in conformance with the Regulation (EU) 2017/745 European Medical Devices Regulation (MDR) and is labeled appropriately.

1.3 Indications for Use Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

1.4 Performance Data Design Validation (animal/cadaver) The safety and efficacy of the instruments were assessed in representative simulated clinical settings that utilized porcine models (in vivo and ex vivo tissue) and cadavers to evaluate applicable requirements through normal clinical use and reasonable expected misuse. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use, including indicated vessel sizes, has been met. Chronic Study (animal) A chronic animal study was performed to evaluate the clinical performance (long-term seal quality) of the subject device Vessel Sealer Extend as compared to the predicate device, Vessel Sealer. This study allowed for the clinical assessment of vascular seal performance and the vascular healing response in a live porcine model. Clearance is not based on human clinical testing. There is no animal model predictive of how the device functions when used to seal vessels containing atherosclerotic plaque.

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Introduction

1.5 Compatibility Information The rated accessory voltage of the Vessel Sealer instrument is 220 Vp (440 Vp-p). Vessel Sealer Extend is compatible for use with: •

da Vinci Xi Surgical System, Model IS4000

•

da Vinci X Surgical System, Model IS4200

•

ERBE VIO dV electrosurgical generator

WARNING: Use Vessel Sealer Extend with a compatible electrosurgical generator to prevent user or patient harm.

Figure 1.1 VIO dV generator

1.6 Device Description Vessel Sealer Extend consists of a single-use, disposable, 8 mm instrument with an integrated cord that connects to the VIO dV generator. An electrode sealing surface and a cutting blade within the jaws enable sealing and cutting. The electrode sealing surface extends to the distal and proximal ends of the jaw and is textured on one side with ceramic spacers. A slider on the housing allows the user to manually open and close the instrument jaws for intraoperative cleaning and grip release. A lock button on the housing allows the user to lock the jaws open for intraoperative cleaning. Two release buttons on the housing allow the user to remove Vessel Sealer Extend from the sterile adapter on the instrument arm. The discs connect to the instrument wrist and translate the movements of the hand controls (masters) from the Surgeon Console (Figure 1.2). Setup and intraoperative use of Vessel Sealer Extend may require sterile and non-sterile tasks performed by the following users: surgeon, circulating nurse (non-sterile user), or scrub nurse (sterile user). WARNING: Do not use the discs on the instrument to manually control or open the jaws of the instrument. Doing so may cause the blade to become exposed causing patient or user tissue to be cut inadvertently. To manually open the jaws, advance the grip release slider on the instrument housing.

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Introduction

Single-use disposable 8 mm Vessel Sealer Extend

Discs

Instrument Cord Connector

Close-up of housing Discs

Shaft Release button

Wrist End of cut boundary Garage

Integrated Cord

Grip release

Jaws Ceramic Spacer

slider Lock Button

Electrode sealing surface Cutting blade track Figure 1.2 Vessel Sealer Extend features

Sealing Vessel sealing requires a combination of energy application, force, and time. When the instrument is connected to the ERBE VIO dV, the generator is automatically configured to use BiClamp mode with Auto Stop (effect level is 1 and modulation is 180 ms). The effect level and modulation for this mode are set automatically and cannot be changed. For full information on BiClamp mode with Auto Stop, see the VIO dV User Manual.

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Introduction If the grips are fully closed when the blue pedal is pressed, the Vessel Sealer Extend instrument achieves high grip force during energy application to support vessel sealing. When the instrument is used for grasping or spot bipolar, the provided grip force is reduced. Ensure the hand controls are fully closed throughout the entire sealing cycle when vessel sealing is needed. To optimize vessel sealing capabilities, always allow the full sealing sequence to complete prior to releasing the grips or foot pedal. The sealing cycle is designed to provide the full amount of time needed for optimum sealing performance and automatically stops once the sealing cycle is complete. It is possible to apply bipolar energy (that is, spot bipolar) with the instrument without fully closing the hand controls. Bipolar energy activation does not apply the high grip force needed to reliably seal the vessel. When bipolar energy is delivered, the activation sequence can be controlled using the foot pedal. If bipolar energy is activated continuously, it will automatically stop once the energy cycle is complete. Table 1-1 summarizes how energy application, force and time are related to the function of the instrument for sealing vs. bipolar energy (such as spot bipolar) using the blue pedal. Table 1-1 Instrument Function for Sealing vs. Bipolar Energy Modes Instrument Function (UI Indicator)

ERBE VIO dV Energy Mode

Hand Control Position

Grip Force

Time

Seal

BiClamp mode with Hand controls Auto Stop fully closed

High

Full sealing cycle

Bipolar

BiClamp mode with Hand controls Auto Stop not fully closed

Nominal

Full cycle not required

Cutting WARNING: Avoid cutting tissue bundles or hard objects where the distance between the tips of the jaws is more than 4 mm. For vessels up to 7 mm and for tissue bundles that fit within the jaws of the instrument, the acceptable jaw gap should be achievable. Cutting larger tissue bundles may lead to an exposed blade or insufficient sealing may occur. The garage, located at the jaw hinge, is a protective area for storing the blade when not in use (Figure 1.2). When cutting is performed, a knife blade travels from the garage along the cutting blade track in the electrodes. For optimal knife travel, the jaws of the instrument should be nearly closed to allow the blade contact with both blade tracks while cutting. Avoid cutting tissue bundles or hard objects where the distance between the tips of the jaws is more than 4 mm. For vessels up to 7 mm and for tissue bundles that fit within the jaws of the instrument, the acceptable jaw gap should be achievable. Cutting larger tissue bundles may lead to an exposed blade. To enforce the acceptable gap when cutting, the hand controls must be fully closed. Additionally, if the hand controls are fully closed but the target tissue is too thick or hard, the jaws of the instrument can remain open by an excessive amount and the system will disallow cutting. For more information, see Chapter 3, Troubleshooting, section 3.1 Blade Exposed, section 3.4 Close Grips to Enable Cutting and section 3.5 SmartCut: Target Tissue Too Thick. Note: A tissue bundle is a set of vessels or lymphatic channels, running in parallel closely together, embedded in connective tissue.

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Introduction

1.7 General Warnings and Cautions WARNING: Only surgeons who have developed adequate robotic skills to perform the tasks associated with each procedure and who have received specific training provided by Intuitive Surgical, Inc., in the use of the da Vinci systems should use the system. Training provided by Intuitive Surgical is limited to the use of the da Vinci systems and does not replace the necessary medical training and experience required to perform surgery. WARNING: Only surgeons who have received specific training provided by Intuitive Surgical, Inc., in the use of the Vessel Sealer Extend instrument should use the instrument. Training provided by Intuitive Surgical is limited to the use of the Vessel Sealer Extend instrument and does not replace the necessary medical training and experience required to perform surgery. WARNING: Read all instructions carefully. Failure to properly follow instructions may cause improper functioning of the device. WARNING: Be sure to read and understand all information, particularly the caution and warning information, found in the applicable user manuals before using these products. Failure to properly follow all instructions, including those in the applicable da Vinci system user manual, and instructions supplied with accessory devices like generators, may lead to injury and result in improper functioning of the device. WARNING: Do not use this device with any items that are not specified for use with the Vessel Sealer Extend instrument, to prevent insufficient sealing. WARNING: Use Vessel Sealer Extend with a compatible electrosurgical generator to prevent user or patient harm. WARNING: Exercise caution when working with monopolar instruments close to Vessel Sealer Extend. Unintended energy may be delivered from the active monopolar instrument to Vessel Sealer Extend. This could result in burns to tissue in contact with any of Vessel Sealer Extend's metal parts or its cannula. To exercise caution in these scenarios, the monopolar tip should be closer to the tissue than to Vessel Sealer Extend. WARNING: Do not use Vessel Sealer Extend on bone or other hard surfaces to prevent patient injury or instrument damage. WARNING: Pacemakers and implanted cardioverters/defibrillators can be adversely affected by RF signals. Consult the pacemaker/cardioverter/defibrillator manufacturer for further information when use of electrosurgical equipment is planned in patients with these devices. If the patient has an internal cardiac defibrillator (ICD), consult the ICD manufacturer instructions before performing electrosurgery. WARNING: Fire Hazard: Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories that are activated or hot from use can cause a fire. When not using active accessories, place them in a non-flammable holster or in a clean, dry, non-conductive and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns.

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Introduction WARNING: Avoid contact or close proximity of Vessel Sealer Extend to an active monopolar instrument. This may cause generator faults, interference with, or damage to, the generator. If such damage is suspected, contact Intuitive technical support. See section 1.1 For Technical Support on page 5 for additional information. WARNING: Discontinue use if any damage or abnormality is observed during use. Examples of instrument damage include broken or bent jaws, scratches or cracks on the instrument shaft, defects on the electrode sealing surface, or cuts/damage to the insulation on the wires. Never use a damaged or broken instrument, to prevent patient injury. WARNING: To avoid electromagnetic interference (EMI), do not secure the instrument cord directly to metallic objects, nor place the instrument cord in proximity to other equipment. WARNING: Position the instrument cord so as to minimize trip hazards in the operating room. WARNING: In case of system failure while the instrument is grasping tissue, it may be necessary to open the instrument jaws. The instrument jaws may be manually opened by sliding down and holding the grip release slider on the instrument housing. Once the tissue is released, close the jaws to prevent tissue injury. (If the blade is exposed, it is OK to close the jaws on an exposed blade.) Squeeze the release buttons and carefully withdraw the instrument. See Grip Release on page 29 for additional information. WARNING: After removal of the instrument during a system or instrument failure, use caution when opening the jaws to avoid injury due to a potentially exposed cutting blade to prevent delay in surgery. WARNING: 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 methanol, alcohols, etc.), to prevent an explosion or fire. WARNING: Do not use energy based devices to transect seals such as electrosurgical pencils or ultrasonic scalpels. WARNING: The surface of the active electrode may remain hot enough to cause burns after the RF current is deactivated. WARNING: Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts (such as tissue smoke plume and aerosols), protective eye wear, filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures. WARNING: Do not activate Vessel Sealer Extend with an auxiliary foot pedal as inadequate sealing may result. WARNING: Always have a backup instrument available to complete the surgical procedure in case of instrument failure and to prevent bleeding. WARNING: Do not overfill the jaws of the instrument with tissue, because this may cause insufficient sealing.

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Introduction WARNING: Do not use an instrument to clean another instrument inside the patient, to prevent patient injury or instrument damage. See Intraoperative Cleaning on page 22 for information on how to clean the jaws intraoperatively. WARNING: Do not use the lock button on the housing when performing grip release. The lock button on the housing is intended for intraoperative cleaning only. Use of the lock button during grip release could interfere with instrument removal, cause instrument damage, or patient injury. Note: Do not use the lock button on the housing at any time the instrument is installed on the system. The lock button on the housing is intended for intraoperative cleaning only. Use of the lock button while the instrument is installed on the arm could interfere with surgeon control of the instrument.

Vessel Sealer Extend Overview At the start of each procedure, the user connects the end of the instrument cord to one of the bipolar ports on the VIO dV (Figure 1.3). The VIO dV is integrated onto the Vision Cart. Refer to the VIO dV User Manual and the applicable system user manual for power and system connection requirements and all applicable warnings and cautions.

Bipolar port Bipolar port

VIO dV generator

Figure 1.3 Vision Cart with VIO dV

Avoiding, Identifying and Resolving Adverse Electromagnetic Effects Vessel Sealer Extend utilizes the VIO dV generator to intentionally apply RF energy to the patient for treatment purposes. For information regarding interference caused by the unit, refer to the VIO dV User Manual. ________________________________End of section______________________________

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Preparation and Use

2 Preparation and Use 2.1 Open Packaging 1. Inspect the outer box, inner Tyvek lid, and clear plastic blister pack for any potential damage or break in the sterile barrier. 2. Using proper sterile technique, remove Vessel Sealer Extend from its packaging and transfer to the sterile field. •

Always use two people for transfer (one sterile and one non-sterile).

•

Do not let the instrument fall from its packaging on to a surface as damage may possibly occur.

3. Remove the tip protector from the instrument tip prior to instrument installation.

2.2 Inspection Vessel Sealer Extend is for single use only and is provided in a sterile package. WARNING: A breach in the sterile packaging indicates possible contamination. Do not use the instrument if the packaging is not intact.

2.3 Preparation and Installation WARNING: Ensure that the instrument cable is properly connected to the generator to prevent tissue injury to the patient. WARNING: Always have a backup instrument available to complete the surgical procedure in case of instrument failure and to prevent bleeding. WARNING: Do not use excessive force while inserting an instrument, to prevent damage to patient tissue. CAUTION: Ensure that the Vessel Sealer cable is routed properly, so that there is no strain on the cable when connected to the generator. This is done to prevent unintended motion. CAUTION: Avoid contacting conductive portions of the instrument that emit stray energy to prevent patient tissue injury. Note: The VIO dV settings for Vessel Sealer Extend are selected automatically when the instrument is connected.

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Preparation and Use 1. Ensure that the VIO dV AC power cord is plugged into a wall outlet. 2. Press the power button on the front of the VIO dV (Figure 2.1). The generator screen illuminates when the power is on.

VIO dV power on (screen illuminates)

VIO dV power button Figure 2.1 VIO dV power button 3. Orient the instrument cord connector so that the wide depression and molded arrow on the connector are facing up. Insert the connector into either of the bipolar ports on the VIO dV (identified by a blue outline and the word BIPOLAR).

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After the cord is inserted, the VIO dV confirms the instrument is connected to the generator, and automatically configures the generator for BiClamp mode with Auto Stop that is used for Vessel Sealer Extend. The Bipolar mode pod shows BiClamp mode is active for the instrument. The effect is automatically set and cannot be changed; this is indicated by the display of “Effect Auto”. For full information on BiClamp mode with Auto Stop, see the VIO dV User Manual.

Figure 2.2 BiClamp mode with Auto Stop Pod (on ERBE VIO dV) A question mark icon displays, signaling that you still need to install the instrument on the instrument arm (Figure 2.3). Connected to VIO dV but not installed on the instrument arm Vessel Sealer Extend cord connection

Figure 2.3 Vessel Sealer Extend cord connected to generator; not installed on an instrument arm 4. Install Vessel Sealer Extend onto the instrument arm, and ensure the excess cord is out of the way.

Da Vinci Energy | Vessel Sealer Extend

Preparation and Use The system checks for proper installation and then starts a self-test. If the instrument self-test fails, refer to Self-Test Failed on page 15. When the self-test completes, the dV icon appears with the instrument arm number assigned to Vessel Sealer Extend, indicating that energy can be controlled by the Surgeon Console (Figure 2.4). The Patient Cart operator must press the clutch button on the arm to advance the instrument tip through the cannula. Energy can be controlled by the surgeon when the instrument tip is sufficiently advanced through the tip of the cannula. Connected to generator and installed on the instrument arm

Figure 2.4 Connection complete Self-Test Failed If the da Vinci surgical system detects a problem with the instrument after installation, a message appears (Figure 2.5). To troubleshoot: a. Remove and re-install Vessel Sealer Extend on the instrument arm. b. If the message still appears, the instrument may be defective. Install the backup instrument.

Figure 2.5 Failed self-test message WARNING: Do not attempt to remove and re-install the instrument more than once after a self-test failed message, because this may cause patient injury. Install the backup instrument and contact Intuitive Technical Support.

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Preparation and Use

2.4 Intraoperative Use Precautions for Intraoperative Use WARNING: Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. WARNING: Use caution during surgical procedures in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.). Do not use this instrument on atherosclerosis, aneurysmal vessels, calcified vessels, etc., as inadequate sealing may result. WARNING: Avoid activating energy when the jaws are immersed in conductive fluids. Conductive fluids in direct contact with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may compromise the seal or may cause tissue injury. WARNING: Do not use this device on vessels in excess of 7 mm in diameter. WARNING: Do not cut or seal thick tissue bundles larger than the instrument's indications for use, because sealing or transection may be compromised or the instrument blade may become exposed. Skeletonize large tissue bundles and critical sealing targets prior to sealing whenever possible. WARNING: Close the hand controls fully throughout an entire seal and cut cycle to ensure proper function. Sealing with the hand controls open may compromise the seal.

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WARNING: Do not touch the jaws to any clips, sutures, staples, plastics, or other metal objects while energized. This may compromise the seal, damage the instrument, or cause patient harm. WARNING: Do not use this instrument to energize or heat the tips of other instruments. This may injure the patient and damage the instrument. WARNING: Avoid contact or close proximity of Vessel Sealer Extend to an active monopolar instrument. This may cause generator faults, interference with, or damage to, the generator. If such damage is suspected, contact Intuitive technical support. See For Technical Support on page 5 for additional information. WARNING: Use care, as thermal spread adjacent to target tissue may result in unintended burns to surrounding tissue. WARNING: Do not seal if jaws are contaminated with carbonized tissue. Ensure jaws are clean during use to prevent insufficient sealing. See Intraoperative Cleaning on page 22 for additional information. WARNING: Remove the instrument from the system first to correctly clean the debris and to prevent instrument damage resulting in fragments in the patient or injury to the patient. WARNING: Do not use any instrument to clean the instrument inside the patient, to prevent patient injury or instrument damage. See Intraoperative Cleaning on page 22 for information on how to clean jaws intraoperatively.

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Preparation and Use WARNING: Do not cut sealed tissue unless the desired tissue effect is observed, and the audio tones from the generator indicate that the sealing cycle completes, to prevent bleeding. WARNING: Eliminate tension on the tissue while sealing and cutting, as the seal may be compromised. WARNING: Use instruments with care. Avoid contact between instruments inside the patient and do not use any instrument to apply force to another instrument inside the patient to prevent patient harm or instrument damage. WARNING: Do not activate the instrument with an auxiliary foot pedal, as inadequate sealing may result. WARNING: Always insert and remove the instrument under visualization to prevent tissue injury. WARNING: Ensure that tissue is not held within or near the instrument jaws before removing the instrument from the system to prevent patient injury. When the instrument is removed from the system and is disengaged from the sterile adapter, the jaws will spring closed. WARNING: When applying energy, use the minimum energy necessary to achieve the desired effect. WARNING: Discontinue use if any damage or abnormality is observed during use. Examples of instrument damage include broken or bent jaws, scratches or cracks on the instrument shaft, defects on the electrode sealing surface, or cuts/damage to the insulation on the wires. Never use a damaged or broken instrument, to prevent patient injury. WARNING: The incorrect activation of an instrument may result in tissue injury. WARNING: Do not grasp or cut clips, suture, staples, plastics, or other metal objects, because damage to the electrode or blade may occur, or patient harm. WARNING: Alternative methods to establish adequate hemostasis in case of insufficient sealing should be held readily available in the OR to prevent bleeding. WARNING: Always have a backup instrument available to complete the surgical procedure in case of instrument failure and to prevent bleeding. WARNING: Only use the Surgeon Console foot pedals as described in the instructions. Failure to follow this warning may cause tissue injury. WARNING: Do not use an instrument when adequacy of hemostasis cannot be verified visually after sealing is complete, to prevent bleeding. WARNING: Ensure critical vessels are visible and within the boundaries of the electrode and sufficiently compressed prior to sealing to prevent insufficient sealing. WARNING: Repeated sealing application may cause the jaws to stick to the tissue and could result in bleeding. If this occurs, see Intraoperative Cleaning on page 22 for additional information. CAUTION: Avoid contacting conductive portions of the instrument that emit stray energy to prevent patient tissue injury.

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Preparation and Use CAUTION: An accidental lever press can cause unintentional disengagement of the instrument and it may lead to non-intuitive motion or loss in advanced functionality.

Overview: Seal and Cut Vessel Sealer Extend is activated from the associated pair of activation pedals on the Surgeon Console (Figure 2.6). The blue pedal provides activation of bipolar energy to perform sealing of vessels (seal). The yellow pedal provides activation of the cutting function (cut).

Yellow: Cut

Blue: Seal

Figure 2.6 Surgeon Console energy activation pedals Jaw labeling and Electrode Surface The white lines on the instrument tip indicate the end-of-cut (transection) boundary, and the smooth electrode surface indicates the seal boundary (Figure 2.7). The width of the jaw can be used to estimate vessel size. For reference, the jaw width at the location shown in Figure 2.7 is approximately 5 mm in length. Top view

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Side view

~5 mm

Cutting blade track Ceramic Spacer Electrode sealing surface

End of cut boundary

Figure 2.7 Jaw and Electrode Surface, side view (left) and top view (right)

Da Vinci Energy | Vessel Sealer Extend

Preparation and Use

Instructions for Intraoperative Use WARNING: Always insert and remove the instrument under visualization to prevent tissue injury. WARNING: Do not place the vessel or tissue in the jaw hinge. Place the vessel or tissue in the center of the jaws, to prevent insufficient sealing. Ensure that the instrument jaws are not in contact with non-target tissue and that you are not applying tension to the tissue. WARNING: Only use the Surgeon Console foot pedals as described in the instructions. Failure to follow this warning may cause tissue injury. WARNING: Release the hand control to open the jaws and prevent tissue injury. Note: While seal or cut mode is active, and the hand control is closed, the instrument arm associated with the instrument locks and will not move. The arm remains locked and will not move or open the instrument jaws until you release the associated pedal. Note: It is possible to apply bipolar energy with the instrument without fully closing the hand control. When energy activation is performed and the hand control is not fully closed, the associated blue pedal icon displays “Bipolar”.

Position and Grasp Target Tissue When the instrument is available (that is, properly connected to a compatible generator and the instrument arm), the associated pedals are enabled (indicated by blue and yellow icons). The pedals will be labeled with their functionality as shown (Figure 2.8). You can then follow the instructions below.

Figure 2.8 Vessel Sealer Extend ready - Bipolar 1. Position the instrument jaws around the target tissue. Make sure the jaws are not in contact with non-target tissue, and that the target tissue is within the electrode sealing surface and end-of-cut boundary (see Figure 2.7). 2. Squeeze the hand control (master) to close the jaws completely onto the target tissue. When the hand control is closed completely, the pedal icon associated with the blue pedal will display “Seal” (Figure 2.9). Activate seal or cut mode as described next:

Figure 2.9 Vessel Sealer Extend ready - Seal

Seal WARNING: Use caution during surgical procedures in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.). Do not use this instrument on calcified vessels, as inadequate sealing may result. WARNING: Avoid activating energy when the jaws are immersed in conductive fluids. Conductive fluids in direct contact with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may compromise the seal or may cause tissue injury.

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Preparation and Use WARNING: Close the hand controls fully throughout an entire seal and cut cycle to ensure proper function. Sealing with the hand controls open may compromise the seal. WARNING: Do not touch the jaws to any clips, sutures, staples, plastics, or other metal objects while energized. This may compromise the seal, damage the instrument, or cause patient harm. WARNING: Use care, as thermal spread adjacent to target tissue may result in unintended burns to surrounding tissue. WARNING: Do not seal if jaws are contaminated with carbonized tissue. Ensure jaws are clean during use to prevent insufficient sealing. See Intraoperative Cleaning on page 22 for additional information. WARNING: Eliminate tension on the tissue while sealing and cutting, as the seal may be compromised. WARNING: Close the hand controls fully to prevent insufficient sealing or bleeding. WARNING: Do not grasp or cut clips, suture, staples or other metal objects, because damage to the electrode or blade may occur, or patient harm. Note: It is possible to apply bipolar energy with the instrument without fully closing the hand control. When energy activation is performed and the hand control is not fully closed, the associated blue pedal icon displays “Bipolar”. To seal tissue, use the associated blue pedal:

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1. Close the hand control to grasp the target tissue only. The width of the jaw can be used to estimate vessel size. For reference, the jaw width at the location shown in Figure 2.7 is approximately 5 mm in length. 2. Holding the hand control completely closed, press and hold the associated blue pedal to seal. The 3D viewer shows the seal pedal is pressed, highlighting the instrument activation status area (Figure 2.10). Continue pressing the pedal to complete the sealing cycle.

Figure 2.10 Seal pedal pressed During the sealing cycle: •

The instrument position will remain locked and the jaws will remain closed until the associated blue pedal is released. If the hand control is opened during the sealing cycle, the user will be required to match grips once the pedal is released.

•

The VIO dV makes an audible signal (a continuous tone) while the pedal is pressed.

•

When the sealing cycle is complete, the VIO dV makes an audible signal (three ascending tones) and automatically stops applying energy.

•

If the system is in a faulted state: The instrument will not allow activation. If sealing is desired, recover the fault and then re-activate a complete sealing cycle before cutting.

Da Vinci Energy | Vessel Sealer Extend