SynchroSeal Instrucments and Accessories User Manual Addendum Rev A

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Copyright © 2018 - 2023 Intuitive Surgical Operations, Inc. All rights reserved.

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

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Contents 1 Introduction... 5 1.1 General Information...6 Contact Information... 6 About this Manual... 6 1.2 Compliance and Classifications...6 Compliance and Classification... 6 1.3 Indications for Use...7 1.4 Compatibility Information...7 1.5 Device Description...7 Sync Energy Activation... 8 Sealing and Spot Coagulation... 9 Summary of Instrument Energy Functionality... 9 1.6 General Warnings and Cautions... 10 SynchroSeal Overview... 12 Avoiding, Identifying and Resolving Adverse Electromagnetic Effects... 13

2 Preparation and Use... 14 2.1 Open Packaging... 14 2.2 Inspection... 14 2.3 Preparation and Installation... 14 Preparation and Installation... 14 2.4 Intraoperative Use... 15 Precautions for Intraoperative Use... 15 Overview: Energy Activation... 17 Instructions for Intraoperative Use... 18 Intraoperative Cleaning... 22 2.5 Instrument Removal... 23 2.6 Instrument Disposal... 23

3 Troubleshooting... 24 SynchroSeal Not Connected to E-100... 24 SynchroSeal Disconnected from E-100 during Energy Activation... 24 E-100 Not Powered On... 24 3.1 Incomplete Energy Delivery... 25 Incomplete Sealing Cycle-E-100... 25 Timeout Reached... 26 3.2 Tissue Too Thick... 26 3.3 Close Grips to Enable Sync... 27 3.4 Applying Energy or Cutting in a Faulted State... 27 3.5 Other Instrument Problems... 27 3.6 Grip Release... 27

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4 4 Symbols and Icons Reference Table... 30 5 Sterilization Methods... 31 6 Natural Rubber Latex... 32

da Vinci SynchroSeal

Introduction

1 Introduction This addendum to the da Vinci Xi and da Vinci X System Instruments and Accessories User Manual provides details specific to SynchroSeal (referred to in this document as SynchroSeal or the instrument). SynchroSeal is designed to be used with a compatible da Vinci surgical system and electrosurgical generator. This document provides instructions to use SynchroSeal in conjunction with the da Vinci Energy E-100 generator (referred to as the E-100). It is not a reference for surgical techniques. Refer to the applicable system user manual for full system information and warnings. Refer to the E-100 User Manual for full generator information, warnings, and troubleshooting. Failure to properly follow all instructions, including instructions supplied with the da Vinci system and compatible generators may lead to injury and result in improper functioning of the device. Note: SynchroSeal 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. CAUTION:

DO NOT RE-STERILIZE.

DO NOT RE-USE.

Reprocessing and/or reuse of products intended for single use may result in degraded instrument performance or loss of functionality, and in exposure to viral, bacterial, fungal, or prionic pathogens. CAUTION:

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.

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Introduction

1.1 General Information 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: +41.21.821.2020  Fax: +41.21.821.2021

For Technical Support If the system requires maintenance or service, please 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 +41.21.821.2020. 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 SynchroSeal. The representative images provide instruction on the use of the products and apply to SynchroSeal. 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 SynchroSeal is in conformance with the Medical Device Directive 93/42/EEC and is labeled appropriately.

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Introduction

1.3 Indications for Use SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal 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 Compatibility Information SynchroSeal is compatible for use with both the da Vinci Xi and da Vinci X systems, Models IS4000 and IS4200, respectively. The rated accessory voltage of SynchroSeal is 600 Vp (1200 Vp-p). WARNING: SynchroSeal is intended for use only with the E-100 electrosurgical generator. Use of SynchroSeal with other noncompatible generators could result in injury to the patient or surgical team, or cause damage to the instrument. Table 1-1 shows compatible cannula options for SynchroSeal. The instrument may be used with either an 8 mm cannula, or a 12 mm cannula with 12 - 8 mm reducer. Table 1-1 SynchroSeal-Compatible Cannula Options Component Name

Part Number (PN)

8 mm Cannula, Standard

PN 470002

8 mm Cannula, Long

PN 470004

12 mm & Stapler Cannula, Standard PN 470375 12 mm & Stapler Cannula, Long

PN 470389

12 - 8 mm Reducer

PN 470381

1.5 Device Description SynchroSeal is an advanced bipolar instrument that provides a unique energy mode to enable sealing and transection of vessels and tissue bundles with a single pedal press. In addition to this functionality, SynchroSeal has the ability to grasp, dissect and spot coagulate tissue, and to independently seal vessels. SynchroSeal, when used with a compatible electrosurgical generator, creates a seal and transects tissue by application of radiofrequency (RF) energy to vessels and tissue bundles that fit in the jaws of the instrument. Electrode sealing surfaces and a cut electrode within the jaws enable sealing and cutting. SynchroSeal consists of a single-use, disposable, 8 mm instrument with an integrated cord that connects to the E-100 electrosurgical generator. The electrode sealing surface extends toward the distal and proximal ends of the jaw and is textured on one side with ceramic spacers. The moveable side of the jaw contains a cut electrode to enable transection. The stationary side of the jaw contains a blue spring pad that enables tissue contact with the cut electrode during transection. The instrument also includes an integrated jaw cover. 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

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Introduction SynchroSeal from the sterile adapter on the instrument arm. The discs connect to the instrument wrist and translate the movements of the hand controls from the Surgeon Console. Setup and intraoperative use of SynchroSeal may require sterile and non-sterile tasks performed by the following users: surgeon, circulating nurse (non-sterile user), or scrub nurse (sterile user). Note: A tissue bundle is a set of vessels and/or lymphatic channels, running in parallel closely together, embedded in connective tissue.

Single-Use Disposable 8 mm SynchroSeal Discs

Guide for Vessel Size End of Cut Boundary

Integrated Cord

Close-up of Housing Shaft Release Button

Wrist End of Cut Boundary Jaw Cover Cut Electrode Ceramic Spacers

Grip Release Slider

Spring Pad

Lock Button

Electrode Sealing Surfaces

Figure 1.1 SynchroSeal features

Sync Energy Activation Vessel sealing requires a combination of energy application, force and time. When the instrument is connected to the E-100 generator and the yellow pedal is pressed, the generator is automatically configured to use Sync mode with Auto Stop for single-step sealing and transection. Settings are determined when the instrument is connected to the system and cannot be adjusted or changed. The instrument features a protruding cut electrode on the movable jaw that enables tissue transection through the delivery of bipolar cut energy. The electrode sealing surfaces enable vessel sealing through a combination of bipolar energy, compression, and time.

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Introduction For optimal performance, the jaws of the instrument should be fully closed to allow appropriate sealing compression during transection. Sync mode should be avoided on very large tissue bundles or hard objects. To support Sync mode, the hand controls must be fully closed when the yellow pedal is pressed. SynchroSeal achieves high grip force during energy application in this mode. Close the hand controls fully throughout the entire sealing cycle when Sync energy is needed. To optimize sealing capabilities, always perform energy activation for a full sealing cycle (i.e. until Auto Stop/success tone from the generator) prior to releasing the grips or foot pedal. The sealing cycle is designed to provide the full amount of time and compression needed for optimum sealing performance.

Sealing and Spot Coagulation When the instrument is connected to the E-100 generator and the blue pedal is pressed, the generator is automatically configured to enable bipolar energy delivery with SynchroSeal, either in Sealing mode with Auto Stop or spot coagulation mode without Auto Stop. Settings are determined when the instrument is connected to the system and cannot be adjusted or changed. If the grips are fully closed when the blue pedal is pressed, SynchroSeal achieves high grip force during energy application to support vessel sealing. Ensure the hand controls are fully closed throughout the entire sealing cycle when vessel sealing is needed to enable this high grip force. To optimize vessel sealing capabilities, always allow the full sealing sequence to complete (i.e. until Auto Stop/success tone from the generator) 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 to spot coagulate tissue with SynchroSeal without fully closing the hand controls. When the instrument is used for grasping or spot coagulation, the provided grip force is reduced. Spot coagulation does not have Auto Stop feedback and can be done when the hand controls are not fully closed. The maximum amount of time spot coagulation can be enabled for is 10 seconds.

Summary of Instrument Energy Functionality The following table summarizes how energy application, force, and time are related to the function of the instrument for Sync, independent sealing, and spot coagulation modes. Table 1-2 summarizes how energy application, force and time are related to the function of the instrument for different energy modes. Table 1-2 E-100-Instrument Function for Energy Modes Instrument Function (UI Indicator)

Associated Foot Pedal

E-100 Energy Mode

Hand Control Position

Grip Force

Time

SYNC

Yellow

Sync mode with Auto Stop

Hand controls  fully closed

High

Full sealing cycle

SEAL

Blue

Sealing mode with Hand controls Auto Stop fully closed

High

Full sealing cycle

COAG

Blue

Bipolar mode Hand controls without Auto Stop not fully closed

Nominal

User controlled (up to a maximum of 10 seconds)

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Introduction Table 1-3 summarizes the audio tones and status descriptions during and after energy activation from SynchroSeal. Table 1-3 Audio Status Status

Status Description

Tone Description Coag: Continuous

Activated

An activation tone is provided throughout the Sealing: Continuous duration of energy activation for each of the energy modes. Sync: Alternating

Success

A success tone indicates when the Sealing or Sync mode cycle has been successfully completed.

Ascending three beeps

Error

An error tone indicates an error related to the E-100 Three beeps generator has occurred or that the energy cycle was unsuccessful.

1.6 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: 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 SynchroSeal. WARNING: Do not use SynchroSeal in any configuration other than with a compatible generator. WARNING: Exercise caution when working with monopolar instruments close to SynchroSeal. Unintended energy may be delivered from the active monopolar instrument to SynchroSeal. This could result in burns to tissue in contact with any of SynchroSeal's metal parts or its cannula. To exercise caution in these scenarios, the monopolar tip should be closer to the tissue than to SynchroSeal. WARNING: Do not use SynchroSeal on bone or other hard surfaces.

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Introduction 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. WARNING: Avoid contact or close proximity of SynchroSeal to an active monopolar instrument. This may cause generator faults, interference with, or damage to, the generator. If such damage is suspected, contact Intuitive Surgical technical support, see section For Technical Support on page 6. 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 surfaces, tears on the jaw cover, or cuts/damage to the insulation on the wires. Never use a damaged or broken instrument. 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 by advancing the grip release slider on the housing. Once the tissue is released, close the jaws. Squeeze the release buttons and carefully withdraw the instrument. See Grip Release on page 27. WARNING: 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. 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 alcohol), as explosion may occur. 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.

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Introduction 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. CAUTION: Leaving the jaws open after cleaning may make instrument insertion into the cannula difficult. Press the lock button on the housing to clean the instrument jaws. After cleaning is complete, advance and release the grip release slider to close the jaws. CAUTION: Always have a backup instrument available to complete the surgical procedure in case of instrument failure. CAUTION: 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. CAUTION: Do not overfill the jaws of the instrument with tissue, as this may reduce device performance.

SynchroSeal Overview At the start of each procedure, the user connects the end of the instrument cord to the bipolar port on the E-100 generator (Figure 1.2). The generator is integrated into the Vision Cart. Refer to the E-100 User Manual and the applicable system user manual for power and system connection requirements and all applicable warnings and cautions.

Bipolar port

E-100 generator

Figure 1.2 Vision Cart with E-100 generator

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Introduction

Avoiding, Identifying and Resolving Adverse Electromagnetic Effects SynchroSeal utilizes a generator to intentionally apply RF energy to the patient for treatment purposes. For information regarding potential interference caused by a generator, refer to the applicable generator 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. CAUTION: A breach in the sterile packaging indicates possible contamination. Do not use the instrument if the packaging is not intact. 2. Using proper sterile technique, remove SynchroSeal 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.

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3. Remove the Tip Protector from the instrument tip prior to instrument installation.

Figure 2.1 Tip Protector

2.2 Inspection SynchroSeal is for single use only and is provided in a sterile package. Inspect the instrument prior to use. Advance the slider on the housing to open the jaws of the instrument and inspect the surface of the stationary jaw for the presence of ceramic spacers.

2.3 Preparation and Installation Preparation and Installation CAUTION: Always have a backup instrument available to complete the surgical procedure in case of instrument failure. Note: The E-100 settings for SynchroSeal are selected automatically when the instrument is connected. 1. Ensure that the E-100 power cord is connected to the AC power outlet. 2. Press the power button on the front of the E-100. The power button illuminates solid white when the power is on.

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Preparation and Use 3. Orient the instrument cord connector so that the wide depression and molded arrow on the connector are facing up. Insert the connector into the bipolar port on the E-100 (identified by a blue outline and the word BIPOLAR). LED illuminates white when the connector is plugged into the bipolar port and installed on the system arm Figure 2.2 Instrument cord connected to generator-E-100 4. Install SynchroSeal onto the instrument arm, and ensure the excess cord is out of the way. The generator configures to the appropriate energy mode and the LED on the generator illuminates white, indicating that the delivery of energy can be initiated from the Surgeon Console. SynchroSeal settings are automatically set and cannot be changed. For information on the SynchroSeal energy modes, see the E-100 generator User Manual. 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.

2.4 Intraoperative Use Precautions for Intraoperative Use WARNING: SynchroSeal 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 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 unintended burns to the patient. WARNING: Do not seal or transect thick tissue bundles larger than the instrument's indications for use to prevent insufficient sealing, which may result in bleeding. Do not use this device on vessels in excess of 5 mm in diameter as sealing or transection may be compromised. Skeletonize large tissue bundles and critical sealing targets prior to sealing and whenever possible. WARNING: Ensure that critical vessels are visible and within the boundaries of the electrode and sufficiently compressed before sealing, to prevent insufficient sealing. WARNING: To avoid inadvertent arcing from the cut electrode during activation of Sync mode, do not fire the instrument if the seal and cut electrodes are not in contact with the intended tissue.

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Preparation and Use WARNING: Close the hand controls fully throughout an entire Sync 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 or other metal objects while energized. This may compromise the seal. WARNING: Do not use this instrument to energize or heat the tips of other instruments. This may injure the patient and damage the jaws. WARNING: Use care, as thermal spread adjacent to target tissue may result in unintended burns to surrounding tissue. WARNING: While activating energy, maintain visibility of the jaws and be aware of anatomy that is in contact with any exposed metal, as unintended tissue effect may occur. WARNING: If the jaws are contaminated by carbonized tissue prior to sealing, insufficient sealing and tissue sticking can occur. Ensure that the jaws are clean during use. See Intraoperative Cleaning on page 22. WARNING: Do not use any instrument to clean the instrument inside the patient. To clean the jaws intraoperatively, see Intraoperative Cleaning on page 22. WARNING: When using Sealing mode, 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. WARNING: Eliminate tension on the tissue while sealing, as the seal may be compromised.

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WARNING: Take caution when moving instrument jaws during sealing as excessive tension may compromise the seal. 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. WARNING: Always insert and remove the instrument under visualization. WARNING: Ensure that tissue is not held within or near the instrument jaws before removing the instrument from the arm. When the instrument is removed from the arm and is disengaged from the sterile adapter, the jaws will spring closed and could cause tissue damage. 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 surfaces, tears on the jaw cover, or cuts/damage to the insulation on the wires. Never use a damaged or broken instrument. CAUTION: Do not grasp or cut clips, suture, staples or other metal objects, as damage to the electrode may occur. CAUTION: Repeated sealing application may cause the jaws to stick to the tissue. If this occurs, see Intraoperative Cleaning on page 22. CAUTION: As a general precaution, alternative methods to establish adequate hemostasis in case of insufficient sealing should be held readily available in the OR.

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Preparation and Use CAUTION: Always have a backup instrument available to complete the surgical procedure in case of instrument failure.

Overview: Energy Activation SynchroSeal is activated from the associated pair of foot pedals on the Surgeon Console (Figure 2.3). The yellow pedal provides activation of bipolar energy to enable a single-step transection and sealing (Sync). The blue pedal provides activation of bipolar energy to perform sealing of vessels (Seal) or to perform spot coagulation (Coag).

Yellow: Single-step Sync

Blue: Seal or Coag

Figure 2.3 Surgeon Console energy activation pedals Jaw Labeling and Electrode Surfaces A protruding electrode on the movable jaw allows for bipolar cut energy to transect tissue. The surrounding electrode surfaces indicate the sealing surfaces. The white line on the instrument tip indicates the end-of-cut (transection) boundary. The outer surface of both jaws has a 5 mm zone of white dots that can be used as a guide to estimate vessel diameter size. This marking is for reference only and may be used to assess whether target vessels are within indication. Shaft Wrist End of Cut Boundary Guide for Vessel Size

Jaw Cover Cut Electrode Ceramic Spacers Electrode Sealing Surfaces Figure 2.4 Jaw Labeling and Electrode Surfaces

Spring Pad

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End of Cut Boundary

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Preparation and Use

Instructions for Intraoperative Use WARNING: Always insert and remove the instrument under visualization. WARNING: Take caution when moving instrument jaws during sealing as excessive tension may compromise the seal. WARNING: Do not place the vessel and/or tissue in the jaw hinge. Place the vessel and/or tissue in the center of the jaws. Ensure that the instrument jaws are not in contact with non-target tissue and that you are not applying tension to the tissue. Note: While the Sealing and Sync modes are active, and the hand controls are closed, the jaws will lock and remain locked until the associated pedal is released. The instrument arm associated with the instrument will not lock and is free to move during the Sealing and Sync cycles. Note: It is possible to apply bipolar energy with the instrument using the blue pedal without fully closing the hand controls. When energy activation is performed and the hand controls are not fully closed, the associated blue pedal icon displays “COAG”.

Position and Grasp Target Tissue When the instrument is available (that is, properly connected to the E-100 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 on the pedal icon. You can then follow the instructions below.

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1. Position the instrument jaws near the target tissue. Make sure the jaws are not in contact with non-target tissue, and that the target tissue is within the entire width of the electrode sealing surfaces. When the hand controls are not closed completely, the pedal icon associated with the blue pedal will display “COAG”.

Figure 2.5 SynchroSeal in Spot Coagulation mode 2. Squeeze the hand controls to close the jaws completely onto the target tissue. When the hand controls are closed completely, the pedal icon associated with the blue pedal will display “SEAL”. Activate energy modes as described below.

Figure 2.6 SynchroSeal in Sealing mode 3. A marking (approximately 5mm) is indicated on the top of the SynchroSeal jaws. This marking may be used for assessing whether target vessels are within indication. These markings are for reference only. Use clinical judgment before grasping or applying energy.

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Preparation and Use

Sync WARNING: Do not seal or transect thick tissue bundles larger than the instrument's indications for use to prevent insufficient sealing, which may result in bleeding. Do not use this device on vessels in excess of 5 mm in diameter as sealing or transection may be compromised. Skeletonize large tissue bundles whenever possible. 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 sealing vessels 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 cause unintended burns to the patient. WARNING: While activating energy, maintain visibility of the jaws and be aware of anatomy that is in contact with any exposed metal, as unintended tissue effect may occur. WARNING: To avoid inadvertent arcing from the cut electrode during activation of Sync mode, do not fire the instrument if the seal and cut electrodes are not in contact with the intended tissue. WARNING: Use caution when releasing tissue from the jaws of the instrument after applying Sync energy with the yellow pedal if the audio tone from the generator indicates unsuccessful completion of the sealing cycle (i.e. error tone). WARNING: Close the hand controls fully throughout an entire seal or Sync 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 or other metal objects while energized. This may compromise the seal. WARNING: Use care, as thermal spread adjacent to target tissue may result in unintended burns to surrounding tissue. WARNING: If the jaws are contaminated by carbonized tissue prior to sealing, insufficient sealing and tissue sticking can occur. Ensure that the jaws are clean during use. See Intraoperative Cleaning on page 22. WARNING: Take caution when moving instrument jaws during sealing as excessive tension may compromise the seal. To simultaneously seal and transect tissue, use the associated yellow pedal: 1. Close the hand controls to grasp the target tissue only. 2. Holding the hand controls completely closed, press and hold the associated yellow pedal to apply Sync energy. The 3D viewer shows the yellow pedal is pressed, highlighting the instrument activation area. Continue pressing the pedal to complete the cycle. During the Sync cycle: •

The jaws will remain locked (but the wrist will allow movement) until the Sync cycle is complete. If the hand controls are opened during the Sync cycle, the user must match grips (that is, close the hand controls to match the instrument jaw position) upon cycle completion in order to open the instrument jaws.

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Preparation and Use •

The generator will make an audible tone (an alternating tone) while the pedal is pressed.

•

When the Sync cycle is complete, the generator will make audible tones and automatically stop applying energy.

3. 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. 4. If the E-100 sounds a successful completion tone, inspect the sealed area for the desired tissue effect. If the desired tissue effect is not observed, or if the E-100 sounds an audible error tone, take caution when releasing tissue from the jaws of the instrument. If an insufficient seal is observed, reposition and re-grasp tissue in the desired location. Reactivate as needed.

CAUTION: Repeated sealing application may cause the jaws to stick to the tissue. If this occurs, see Intraoperative Cleaning.

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.

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WARNING: Avoid sealing vessels 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 cause unintended burns to the patient. WARNING: Use caution when releasing tissue from the jaws of the instrument after applying Sync energy with the yellow pedal if the audio tone from the generator indicates unsuccessful completion of the sealing cycle (i.e. error tone). WARNING: Close the hand controls fully throughout an entire seal or Sync cycle to ensure proper function. Sealing with the hand controls open may compromise the seal. WARNING: Take caution when moving instrument jaws during sealing as excessive tension may compromise the seal. WARNING: Do not touch the jaws to any clips, sutures, staples or other metal objects while energized. This may compromise the seal. WARNING: Use care, as thermal spread adjacent to target tissue may result in unintended burns to surrounding tissue. WARNING: Ensure that critical vessels are visible and within the boundaries of the electrode and sufficiently compressed prior to sealing, to prevent insufficient sealing. WARNING: While activating energy, maintain visibility of the jaws and be aware of anatomy that is in contact with any exposed metal, as unintended tissue effect may occur. WARNING: If the jaws are contaminated by carbonized tissue prior to sealing, insufficient sealing and tissue sticking can occur. Ensure that the jaws are clean during use. See Intraoperative Cleaning on page 22.

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