Da Vinci Xi and da Vinci X Instruments and Accessories User Manual

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Copyright ©2017–2022 Intuitive Surgical Operations, Inc. All rights reserved.

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

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Table of Contents

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Table of Contents Chapter 1 General Information...7 1.1 How to Use this Manual...7 Non-sterile...8 Knowing What Applies – Organization of this Manual...9 Contact Information... 10 1.2 Limitation on Use – Limited License... 10 1.3 Important Regulatory Information... 11 1.4 General Instructions... 12 Compliance and Classification... 12 Proper Care and Handling... 12 Storage Between Uses... 12 Disposal... 12 Chapter 2 Overview of da Vinci Instruments... 13 2.1 Introduction... 13 2.2 Instruments Overview... 13 Instrument Features... 14 General Warnings and Cautions... 16 Inspection Before Use... 19 2.3 Intraoperative Use... 19 General Precautions for Intraoperative Use of Instruments... 19 Instrument Installation onto Patient Cart Arm...20 Instrument Removal... 21 Manual Grip Release... 22 Troubleshooting Single-Site Instruments with Closed Grips... 24 Instrument Cable Management... 27 2.4 EndoWrist Instrument Overview... 27 Device Description... 27 8 mm Instrument Introducer... 31 2.5 Single-Site Instrument Overview...33 Device Description... 33 Single-Site General Warnings...34 Chapter 3 Overview of Single-Site Surgery...35 3.1 Introduction...35 3.2 Setup for Single-Site Surgery...35 Single-Site Port... 37 Single-Site Instrument Inspection...39 Single-Site Instrument Installation onto Patient Cart Arm...39 Single-Site Instrument Removal...39 3.3 Intraoperative Use...39 3.4 Position the Setup Joints (da Vinci X System)...39 3.5 Place the Single-Site Port... 40 3.6 Insert Cannulas... 41 General Warnings and Cautions... 41 Guidelines for Cannula Insertion and Placement... 42 Endoscope Cannula...44 Targeting on the da Vinci Xi System... 47 Curved Cannulas...49 Accessory Cannula... 52 Connect Patient Neutral Pad Cable to Endoscope Cannula... 53

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Table of Contents

Release Tension and Check Cannula Placement... 55 Cannula and Port Removal... 55 3.7 Automatic Hand Control Associations...55 Arm Swap and Arm/Instrument Status...56 Chapter 4 Large and Medium-Large Clip Appliers... 57 4.1 Introduction... 57 Weck Hem-o-lok Ligating Clips... 57 4.2 Intraoperative Use...58 Precautions for Intraoperative Use...58 Instructions for Intraoperative Use...58 Chapter 5 Small Clip Applier...60 5.1 Introduction...60 5.2 Intraoperative Use...60 Instructions for Intraoperative Use...60 Chapter 6 Using Electrosurgical Units (ESUs)...63 6.1 Introduction...63 6.2 Monopolar and Bipolar Cautery Cords...63 General Warnings and Precautions...63 Compatible ESUs...63 Device Description...64 Instructions for Use...64 Inspection...64 6.3 Electrosurgical Units (ESUs)...65 General Precautions and Warnings...65 6.5 VIO dV 1.0...66 VIO dV 1.0 – Overview...66 VIO dV 1.0 - Selecting Settings...69 VIO dV 1.0 - Control Assignment Indicators...70 6.6 VIO dV 2.0... 71 VIO dV 2.0 - Overview... 71 VIO dV 2.0 - Selecting Settings... 74 VIO dV 2.0 - Control Assignment Indicators...76 6.7 VIO dV - Instrument Activation and Error Messages...78 Bipolar and Monopolar Instrument Activation...79 ERBE VIO dV Error Messages...80 6.8 Non-integrated ESU... 81 Energy Activation Cable and Compatible ESU... 81 Compatible ESU Preparation... 81 General Maintenance - Energy Activation Cable...83 6.9 Electrosurgical Unit (ESU) Settings...83 Monopolar Instruments...83 Bipolar Instruments...84 Proper ForceTriad Configuration Instructions...85 Chapter 7 Monopolar Instruments and Related Accessories...87 7.1 Introduction...87 Monopolar Instrument Overview... 87 7.2 Intraoperative Use...88 Precautions for Intraoperative Use...88 Precautions and Warnings for Endoscope Use with Monopolar Instruments...89

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Instructions for Intraoperative Use...89 Intraoperative Cleaning...89 7.3 Monopolar Curved Scissors Instrument...89 Monopolar Curved Scissors Instrument Overview...89 Tip Cover Accessory...90 General Cautions and Warnings...90 Inspection Before Use... 91 Tip Cover Accessory Installation – Before Use... 91 Disassembly...93 Disposal of Tip Cover Accessory...93 7.4 Permanent Cautery Instrument...93 Permanent Cautery Instrument Overview...93 General Precautions and Warnings - Permanent Cautery Instrument...93 Inspection Before Use...94 Chapter 8 Bipolar Instruments and Related Accessories...95 8.1 Bipolar Instrument Overview...95 8.2 Intraoperative Use...96 Precautions for Intraoperative Use...96 Instructions for Intraoperative Use...96 Intraoperative Cleaning...96 Chapter 9 EndoWrist Suction Irrigator...98 9.1 Overview...98 Compatibility Information...99 Device Description...99 9.2 Instructions for Use... 100 Inspection... 100 Instrument Setup... 100 9.3 Intraoperative Use... 102 Surgeon Console Activation... 103 Best Practices... 103 Patient-Side Activation... 104 Disposal... 105 Chapter 10 Single-Site Suction Irrigator... 106 10.1 Overview... 106 Stryker StrykeFlow 2 Suction Irrigation Pump... 106 10.2 Installation Before Use... 106 10.3 Intraoperative Use... 107 Chapter 11 Cannulas, Obturators, Reducer, and Cannula Seals... 108 11.1 Introduction... 108 11.2 Cannula System Overview... 108 Cannula Lengths... 109 Cannula System Compatibility Information... 110 12 - 8 mm Reducer Versions... 111 General Precautions and Warnings... 114 General Precautions and Warnings for Single-Use Accessories... 115 11.3 Inspection Instructions... 115 Additional Single-Site Curved Cannula Inspection... 116 Gage Pin Inspection for 8 mm Cannulas... 116 11.4 Hasson Cone Overview... 117

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Table of Contents

Device Description... 118 Compatibility... 118 Intraoperative Use... 119 Removal... 120 Reprocessing... 120 11.5 Obturator Overview... 120 Obturators... 121 Single-Site Obturators... 122 11.6 Cannula Seal Overview... 123 Cannula Seals... 123 Single-Site Cannula Seal... 125 11.7 Reducer... 126 11.8 Cannula System Intraoperative Use... 127 11.9 Single-Site Intraoperative Use... 129 Appendix A Reprocessing Preparation in the Operating Room... 130 A.1 Prime and Soak... 130 A.2 Transport to Sterile SPD or CSSD... 130 Appendix B Symbols Defined... 131 Appendix C Natural Rubber Latex... 135 Appendix D Sterilization Methods... 136 D.1 Instruments... 136 D.2 Accessories... 136 Appendix E Intended Use/Indications for Use... 137 E.1 Contraindication - Weck Hem-o-lok Ligating Clips... 137 E.2 Contraindication - da Vinci Hasson Cones... 137 E.3 Intended Use/Indications for Use... 137

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General Information

Chapter 1

General Information

Contents 1.1 1.2 1.3 1.4

How to Use this Manual... 7 Limitation on Use – Limited License... 10 Important Regulatory Information... 11 General Instructions... 12

1.1 How to Use this Manual Note: Not all technologies may be commercially available in all geographies. This manual is not a reference for surgical techniques. It is intended to be kept with the system with which it is used. See the applicable system user manual for more information on connecting the instruments to the system. For cleaning, disinfection, and sterilization of reusable instruments, accessories and components, refer to the appropriate Reprocessing Instructions User Manual. This user manual presents representative images of the system, instruments, accessories, or user interface. The representative images provide instruction on the use of the product. In some cases, the aesthetics or dimensions of the device shown in the representative images may be different from the product in use. Table 1.1 Note, Caution, and Warning Symbol

Meaning Note: Highlights important information. Caution: Alerts the reader about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. It may also be used to alert against unsafe practices. This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse. Warning: Alerts the reader about a situation which, if not avoided, could result in death or serious injury.

WARNING: Be sure to read and understand all information, particularly caution and warning information, found in the applicable user manuals before using these products. Failure to properly follow all instructions, including instructions supplied with accessory devices like electrosurgical units and the applicable user manuals for the da Vinci system may lead to injury and result in improper functioning of the device. Note: Read Knowing What Applies – Organization of this Manual on page 9 to understand what portions of this manual apply to any specific instrument or accessory. If information specific to an instrument or accessory is not included in this manual, Intuitive supplies it with that instrument or accessory.

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Non-sterile Note: Intuitive devices ship non-sterile unless otherwise indicated in the device’s labeling. Clean and sterilize reusable devices before each use, unless they are not used within the sterile field. Note: Use standard sterile technique for proper handling and cleaning of components that enter the sterile field.

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Knowing What Applies – Organization of this Manual Note: This manual describes both EndoWrist and Single-Site instruments and accessories. Unless otherwise specified, the information applies to both suites of instruments and accessories. For specific information on instruments and accessories not covered in this manual, see the user documentation distributed with those products. • This chapter (General Information) applies to all instruments and accessories supplied by Intuitive. • Chapter 2 Overview of da Vinci Instruments on page 13 provides general information and troubleshooting that applies to all da Vinci instruments, including scissors, scalpels, graspers, needle drivers, clip appliers, monopolar and bipolar electrocautery instruments. This chapter also provides information specific to EndoWrist and Single-Site instruments. • Chapter 3 Overview of Single-Site Surgery on page 35 provides information specific to Single-Site surgery. • Chapter 4 Large and Medium-Large Clip Appliers on page 57 provides information specific to the Large and Medium-Large Clip Appliers. • Chapter 5 Small Clip Applier on page 60 provides information specific to the Small Clip Applier. • Chapter 6 Using Electrosurgical Units (ESUs) on page 63 provides general information that applies to all cautery instruments, including electrosurgical unit settings, energy activation cables and cautery cords. • Chapter 7 Monopolar Instruments and Related Accessories on page 87 provides information specific to all Monopolar instruments and related accessories. –

7.3 Monopolar Curved Scissors Instrument on page 89 provides information specific to the Monopolar Curved Scissors instrument.

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7.4 Permanent Cautery Instrument on page 93 provides information specific to the Permanent Cautery instrument.

• Chapter 8 Bipolar Instruments and Related Accessories on page 95 provides information specific to Bipolar instruments. • Chapter 9 EndoWrist Suction Irrigator on page 98 provides information specific to the EndoWrist Suction Irrigator Instrument. • Chapter 10 Single-Site Suction Irrigator on page 106 provides information specific to the Single-Site Suction Irrigator Instrument. • Chapter 11 Cannulas, Obturators, Reducer, and Cannula Seals on page 108 provides information specific to cannulas, obturators, reducers, cannula seals and related accessories. • Appendix A Reprocessing Preparation in the Operating Room on page 130 provides information on reprocessing preparation in the operating room. • Appendix B Symbols Defined on page 131 provides information about symbols that may appear on packaging and labels for instruments and accessories. • Appendix C Natural Rubber Latex on page 135 provides information about products referenced in the manual that are not made with natural rubber latex. • Appendix D Sterilization Methods on page 136 provides information about sterilization methods used for single-use instruments and accessories. • Appendix E Intended Use/Indications for Use on page 137 provides information about proper use of instruments and accessories.

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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 or our products and services. In the U.S.

In Europe

Intuitive Surgical, Inc.

Intuitive Surgical SAS

1266 Kifer Road

11 avenue de Canteranne

Sunnyvale, CA 94086 U.S.A.

33600 Pessac, France

Toll free: 1.800.876.1310

Toll free: +800.0821.2020

Direct: 408.523.2100

Direct: +33.1.77.68.88.45

Fax: 408.523.2377

Fax: +800.0821.2021 or +41.21.821.2021

If the system requires maintenance or service, call our Customer Service line. In the U.S., 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. If you have questions regarding the use, cleaning, sterilizing, or storing of Intuitive devices used with the da Vinci Xi System or the da Vinci X System, contact Intuitive Customer Service at the phone number above. If you have questions regarding the use, cleaning, sterilizing, or storing of Intuitive devices used with the da Vinci Xi System, contact Intuitive Customer Service at the phone number above.

Manufacturer Intuitive Surgical, Inc.

Intuitive Surgical SAS

1266 Kifer Road

11 avenue de Canteranne

Sunnyvale, CA 94086 U.S.A.

33600 Pessac, France

intuitive.com Note: Manufacturer and EC representative information may vary for some items manufactured by an Original Equipment Manufacturer (OEM) partner. Such items are specified in the relevant sections.

1.2 Limitation on Use – Limited License Intuitive da Vinci instruments and accessories are provided pursuant to a limited license to use only with the Intuitive da Vinci Xi system (Endoscopic Instrument Control System, Model IS4000) and the da Vinci X system (Endoscopic Instrument Control System, Model IS4200). Upon expiration of the instrument’s or accessory’s programmed maximum number of uses, this limited license expires. Any repair, refurbishment, reconditioning, or servicing of Intuitive instruments and accessories is strictly prohibited and results in expiration of limited license.

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1.3 Important Regulatory Information Clinical Risks Important Safety Information Patients should talk to their doctor to decide if da Vinci surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options and associated risks in order to make an informed decision. Serious complications may occur in any surgery, including da Vinci surgery, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques which could result in a longer operative time and/or increased complications. Individuals' outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics and/or surgeon experience.

Serious Incident Reporting Serious incident means any incident that directly or indirectly led, might have led, or might lead to any of the following: • the death of a patient, user, or other person, • the temporary or permanent serious deterioration of a patient's, user's, or other person's state of health, • a serious public health threat. For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report the incident to the manufacturer and its authorized representative and to your national authority. In Europe 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

Importer Address European Union

In Switzerland

Intuitive Surgical SAS 11 avenue de Canteranne 33600 Pessac, France

Intuitive Surgical Sàrl Chemin des Mûriers 1 1170 Aubonne, Switzerland

Supplemental Information for da Vinci This section includes clinical benefits information and intended use/indications for use for the da Vinci instruments and accessories.

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Clinical Benefits The overall benefits of the da Vinci system include an expanded access to minimally invasive surgery for an increasing variety of procedures. The potential clinical benefits of the da Vinci system as a minimally invasive tool include lower estimated blood loss, fewer complications and lower length of hospital stay when compared with the open approach and lower or similar rates of conversion, when compared to the laparoscopic approach. These clinical benefits/outcomes may depend on a number of factors, including, but not limited to patient characteristics, disease characteristics, surgeon experience, and hospital/national patient care and recovery pathways.

Intended Use/Indications for Use For Intended Use/Indications for Use of da Vinci Instruments and Accessories, see Appendix E Intended Use/Indications for Use on page 137. For Intended Use/Indications for Use of da Vinci systems, see the applicable system user manual.

1.4 General Instructions Compliance and Classification

2460

Intuitive Surgical da Vinci EndoWrist and Single-Site instruments and accessories that are in conformance with the Regulation (EU) 2017/745 European Medical Devices Regulation (MDR) are labeled appropriately.

Proper Care and Handling Proper care and handling is essential for satisfactory performance of surgical instruments and accessories. Use care when handling devices during setup and operation. Examine the instrument or accessory, including all of its components, thoroughly before and after each use. If any abnormality is found (such as dents), do not use the instrument or accessory. Use the device for its intended purpose only. Do not expose instruments to X-rays, radioactive rays or strong electromagnetic waves. Otherwise, the instrument may be damaged, making it unrecognizable to the system.

Storage Between Uses After removing products from their packaging, store Intuitive instruments, accessories or components in a clean, dry, dark place. Care must be taken to protect the instrument tips from damage.

Disposal When disposing of Intuitive instruments, accessories, or any of their components, follow all applicable national and local laws and guidelines. End of Section

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Overview of da Vinci Instruments

Chapter 2

Overview of da Vinci Instruments

Contents 2.1 2.2 2.3 2.4 2.5

Introduction... 13 Instruments Overview... 13 Intraoperative Use... 19 EndoWrist Instrument Overview... 27 Single-Site Instrument Overview... 33

Note: All da Vinci instruments and accessories in this manual are compatible with both the da Vinci Xi and the da Vinci X systems, unless otherwise specified.

2.1 Introduction This chapter contains general instructions for use specific to da Vinci instruments. The following sections provide general information such as part numbers and device names, intraoperative information, and troubleshooting. Specific information on individual types of instruments can be found in each specific instrument chapter (for example, for large and medium-large clip appliers, see Chapter 4 Large and Medium-Large Clip Appliers on page 57). Note: This chapter describes both EndoWrist and Single-Site instruments and associated accessories. Unless otherwise specified, the information applies to both suites of instruments and accessories. For specific information on instruments and accessories not covered in this manual, see the user documentation distributed with those products. Note: Da Vinci instruments ship non-sterile, unless otherwise indicated in the instrument’s labeling. Clean and sterilize reusable Instruments before use. For details see the Reprocessing Instructions User Manual. Note: Pay attention to all, warnings, and cautions, and follow all instructions related to the setup and docking of instruments and accessories on the system. See the applicable da Vinci user manual to position the Patient Cart before starting any procedure.

2.2 Instruments Overview Intuitive designs instruments to give surgeons natural dexterity and range of motion. This allows for greater precision when operating in a minimally invasive environment.

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Instrument Features Da Vinci instruments consist of the following components: • Instrument housing (Figure 2.1 4): The instrument housing engages with the instrument sterile adapter and includes the: –

Release buttons (Figure 2.1 3): The two release buttons, one on each side of the housing, are used to release the instrument from the sterile adapter for removal.

–

Flush ports (Figure 2.1 5): Two flush ports are used for instrument reprocessing. See the Reprocessing Instructions User Manual for cleaning and sterilization instructions.

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Grip release socket (Figure 2.1 1): Access hole for grip release wrench used to open or move grips manually during a system fault. For more information on grip release, see the applicable system user manual.

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Cautery Cord interface [electrosurgical instruments only] (Figure 2.1 2): Bipolar or Monopolar (depending on instrument type) cautery cords can be plugged into this connection interface.

–

Discs (Figure 2.1 6): The discs connect to the instrument wrist and translate the movements of the hand controls from the Surgeon Console.

–

Maximum use indicator (Figure 2.1 10): An indicator on the instrument housing that turns red when the instrument has reached its maximum uses. For more information on viewing remaining uses, see the applicable system user manual.

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Shaft (Figure 2.1 7): The shaft inserts through the cannula and rotates as controlled by the movements of the hand controls.

• Wrist [if applicable] (Figure 2.1 8): The articulating wrist provides a wide range of movements. • Tip (Figure 2.1 9): The instrument tip (also called grip, jaw, or end effector). Examples include graspers, cautery hooks, and blades. Figure 2.1 da Vinci Xi instrument 3 1 4 5 2

8

7

6

1. Grip release socket 2. Cautery cord interface 3. Release buttons (one on each side) 4. Instrument housing 5. Flush ports 6. Discs 7. Shaft 8. Wrist 9. Tip 10. Maximum use indicator

9

10

Note: The discs can be rotated by hand (when not attached to the sterile adapter) to verify the cable functionality or align the wrist (as applicable) for instrument insertion.

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Refer to the applicable system user manual for more information on connecting the instruments to the system.

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General Warnings and Cautions WARNING: Use proper handling, cleaning, and sterilization of components within the sterile field to prevent breach of sterility. WARNING: Read and understand all information in the user manuals for safe handling, inspection, setup, and operation of instruments and accessories before using these products. WARNING: Always have a backup instrument available to complete the surgical procedure in case of instrument failure or emergencies. This is to prevent delay in therapy, tissue injury, or patient harm. WARNING: Instruments that are single-use only must be disposed of as hazardous biological waste, to prevent contamination, device malfunction, patient injury, or staff injury. WARNING: Unless it is stated, do not use da Vinci instruments on cartilage, bone, or hard objects. Doing so may damage the instrument and make it impossible to remove from the cannula or cause components to fall in the patient. WARNING: Do not grasp tissue with instruments not intended to grasp tissue, as tissue injury may result. For example, do not grasp tissue with clip appliers, which are made to hold and apply plastic ligation clips, or needle drivers, which are made to hold metallic needles. WARNING: Improper use or handling of any components that could get hot could lead to burn injuries. WARNING: Do not deliberately or unintentionally use one instrument to energize other instruments. Energizing other instruments may cause tissue damage inside or outside the field of view. This damage could occur at points near the tip or at the port site (cannula) of the energized instrument. WARNING: Be aware of the risks associated with improper use of accessories related to energy delivery or grounding to prevent tissue injury. WARNING: Surgery should only be performed when the vision system provides sufficient visualization to safely perform surgical tasks, which will help prevent possible tissue injury. WARNING: The force feedback associated with the da Vinci system is different from feedback experienced when using conventional instruments. As with any endoscopic procedure, the surgeon should rely on visual cues to enhance force feedback. WARNING: Unexpected motion can occur when instruments collide, resulting in instrument damage, or patient injury. Ensure there is adequate room for instruments to move inside the patient and for the arms outside the patient to move without contacting the patient during the procedure. Ensure that the patient-side assistant can see all arms during the procedure and can alert the surgeon when the arms are close to contacting the patient. WARNING: Instrument and cannula configurations that are electrically isolated from the body wall have the potential to enable the unintended transfer of monopolar energy.

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WARNING: Do not use one instrument to clean another inside the patient. This is to prevent instrument damage and components left in the patient. If an instrument tip requires cleaning, remove the instrument from the cannula and gently clean the tip. WARNING: Avoid instrument contact or collisions (including endoscopes) inside the patient to prevent tissue injury or damage to the instrument resulting in fragments in the patient. WARNING: Prior to removing a grasping instrument (for example, ProGrasp) from the cannula, release all tissues and approved third-party devices from the grips to avoid jamming between the device and cannula. Removing an instrument while grasping objects could cause jamming and make it impossible to remove the instrument from the cannula. It is recommended to visualize the instrument tip under endoscopic view for removal. WARNING: Avoid contact between instruments intraoperatively and do not use one instrument to apply force to another instrument inside the patient, because tissue injury could result. WARNING: To clean debris from an instrument, first remove the instrument from the patient and system to prevent damage to the instrument resulting in fragments in the patient. WARNING: Do not use an instrument to clean debris from another instrument intraoperatively. This may result in damage to the instruments or other unintended consequences, such as disconnection of the instrument tip. WARNING: Clean and sterilize the instruments immediately after each use to ensure proper cleaning and sterility. Do not allow debris to dry on or inside the instrument intraoperatively before instrument processing. In order to keep the instrument from drying when soiled, keep the instrument in water or an enzymatic bath between the surgical procedure and instrument processing. The instrument may also be flushed through the main flush port with sterile water during use to minimize buildup of internal deposits of bio-material. WARNING: Keep instruments moist during intraoperative use to ensure particulates (for example, tissue, bodily fluids, etc.) do not dry on the instrument. Failing to do so may result in difficulty in removing those particulates during sterile reprocessing and may cause patient infection or immunologic reaction. WARNING: Follow proper instrument and accessory cleaning procedures, to prevent infection. WARNING: Only trained users and those who have developed adequate robotic skills to perform the tasks associated with each procedure should use the system. Training provided by Intuitive is limited to the use of the da Vinci system and does not replace the necessary medical training and experience required to perform surgery. WARNING: Read all instructions, precautions, and contraindications found with the Hem-o-lok ligating clips. Make sure to follow the instructions when the clips are applied with the EndoWrist and Single-Site clip appliers. This will help prevent injury, loss of clips in patient anatomy, or procedure conversion to open procedure. WARNING: Do not use instruments repaired, refurbished, reconditioned, or serviced by a third party to prevent device malfunction or injury to the patient or staff.

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WARNING: Use only the instruments and accessories approved by Intuitive and listed in the user manuals or compatibility documents. System compatibility, safety, and performance with non-approved instrumentation cannot be guaranteed, and could result in tissue injury or damage to the instrument or equipment. CAUTION: Use proper intraoperative cleaning methods and do not use one instrument to clean another inside the patient, to prevent surgeon confusion and tissue injury. CAUTION: Avoid fire hazards, trip hazards, and alternate site burns when setting up energy instruments, to prevent user or patient injury. CAUTION: Da Vinci instruments and accessories should only be used by surgeons trained in minimally invasive surgery. CAUTION: Instruments may exhibit non-intuitive motion due to a lever press or external collision; unexpected instrument movement may cause tissue injury. CAUTION: Da Vinci instruments and accessories should be handled and operated by trained personnel. CAUTION: Handle instruments with care. Avoid mechanical shock or stress that can cause damage to the instruments, because tissue injury could result. CAUTION: Da Vinci instruments are designed and manufactured for a specific surgical function. Use of an instrument for a task other than the instrument’s designed use (such as off-label use) may result in a damaged instrument or patient injury. CAUTION: Avoid collisions or contact between the endoscope arm and instrument arms to prevent patient tissue damage. CAUTION: Prior to using compatible third party devices with the da Vinci Xi system or the da Vinci X system, read all associated instructions for use. CAUTION: Anatomical characteristics of a patient may preclude using minimally invasive techniques. Environmental or equipment failures may cause the da Vinci system to be unavailable. The surgical team should always have backup equipment and instrumentation available, and be prepared to convert to alternative surgical techniques. The potential risk of such conversion should be communicated to the patient. CAUTION: Only use the instruments as directed.

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Inspection Before Use Before use, all instruments should be visually inspected for damage or irregularities. Do not use the instrument if damage or abnormalities are observed. Examples of damage include: • Broken cables or wires • Scratches, cracks or broken parts on the instrument shaft • Cracks or missing pieces where the grips attach to the shaft • Broken, bent, misaligned or gouged instrument tips • Cracked or broken pulleys near the instrument tips • Cracks or missing pieces on the outer components surrounding the pulleys • Loose tip or grips • Broken lever guards (if applicable)

2.3 Intraoperative Use General Precautions for Intraoperative Use of Instruments WARNING: Make sure that the instrument moves smoothly in and out of the cannula. Do not force the instrument through the cannula, because the instrument could be damaged such that components fall in the patient. WARNING: Do not use an instrument to clean debris from another instrument inside the patient. This may result in damage to the instruments or other unintended consequences, such as disconnection of the instrument tip, which could result in patient injury. To clean an instrument intraoperatively, remove the instrument from the system, and wipe the instrument tip with moist sterile gauze. WARNING: Do not manipulate instruments that are outside of the field of view. This may damage the instruments or injure tissue inside or outside the field of view. CAUTION: Da Vinci instruments must be used with the appropriate size and type Intuitive cannula, obturator, instrument, endoscope, reducer, and Hasson Cone pairings because tissue injury or instrument damage could result. See Chapter 11 Cannulas, Obturators, Reducer, and Cannula Seals on page 108 for details. CAUTION: Do not remove the cannula assembly and instrument from the body simultaneously because this may damage the surrounding tissues and the instrument. Note: If instruments cannot be manipulated in a precise and controlled manner, or if instrument motion appears to be non-intuitive, carefully remove the instrument and return the instrument to Intuitive. Contact Intuitive Customer Service immediately. In the U.S., 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. Note: If, while operating, you move the hand controls and no instrument motion occurs, there may be an interference between instruments or arms, or between an arm and the patient. Resolve the interference before proceeding with the surgery. Note: In order to minimize residual soil on the instrument, keep the tips and wrist moist during intraoperative use.

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Overview of da Vinci Instruments | Intraoperative Use

Note: For further details and instructions on instrument installation, insertion, and removal, see the applicable system user manual. For details on intraoperative use of Single-Site instruments and accessories, see 3.3 Intraoperative Use on page 39. For details on intraoperative use of cannulas, see 11.8 Cannula System Intraoperative Use on page 127.

Instrument Installation onto Patient Cart Arm WARNING: Close the instrument jaws prior to insertion into a cannula, to prevent damage to instrument, resulting in potential patient harm. WARNING: Unlock the instrument before installing the instrument onto an arm after intraoperative cleaning, to prevent damage to instrument, which may result in instrument fragments in the patient, or tearing of the cannula seal, which may result in loss of insufflation and instrument fragments in patient. WARNING: Properly use Instrument Release Kit to release instrument jaws from tissue during system faults or power losses, to prevent patient injury. WARNING: The instrument may not be immediately visible when being moved from the cannula into the patient. Move the endoscope to visualize the instrument and use caution when inserting instruments into the patient to avoid tissue injury. WARNING: Make sure that the instrument moves smoothly in and out of the cannula. Do not force the instrument through the cannula, because the instrument could be damaged such that components fall in the patient. WARNING: During instrument insertion using Single-Site instruments, including during Guided Tool Change, avoid excessive force because the tip could move beyond the intended position, or the instrument could be damaged due to flexibility of the shaft, resulting in patient injury. WARNING: Do not use excessive force while inserting an instrument during Guided Tool Change to avoid tissue injury. WARNING: Do not manipulate instruments that are outside the surgeon's field of view, to prevent patient tissue damage. Note: When using Guided Tool Change with Single-Site instruments, there could be a small lateral offset in the tip position of the newly inserted instrument due to the flexibility of the instrument shaft. For information on the 8 mm Instrument Introducer (for use with EndoWrist instruments), see 8 mm Instrument Introducer on page 31.

Da Vinci Xi and da Vinci X Instruments and Accessories User Manual

553930-09 Rev. A