Intuitive DAVINCI XP User Manual
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Intuitive DAVINCI XP User Manual

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Instruments and Accessories
User Manual
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 USA
intuitive.com
Intuitive Surgical, Sàrl
Chemin des Mûriers 1
1170 Aubonne, Switzerland
intuitive.com
PN 553415-03 REV. A 2019.11

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  • Page 1 Instruments and Accessories User Manual Intuitive Surgical, Inc. Intuitive Surgical, Sàrl 1266 Kifer Road Chemin des Mûriers 1 PN 553415-03 REV. A 2019.11 Sunnyvale, CA 94086 USA 1170 Aubonne, Switzerland intuitive.com...
  • Page 2 © 2019 Intuitive Surgical, Inc. All rights reserved. Trademarks Intuitive, Intuitive Surgical, da Vinci, da Vinci SP, EndoWrist SP, EnergyShield, EntryGuide, are trademarks or registered trademarks of Intuitive Surgical, Inc. Product names are trademarks or registered trademarks of their respective holders.

  • Page 3: Table Of Contents

    Contents Contents 1 General Information ........1 1.1 How to Use this Manual ........1 Non-Sterile .
  • Page 4 Contents 3.3 Intraoperative Use ......... . 20 3.4 Postoperative Instructions .
  • Page 5 8 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments ....... . .37 8.1 Introduction.
  • Page 6 A Appendix A: Reprocessing Preparation in the Operating Room ..........70 Prime and Soak .

  • Page 7: General Information

    General Information General Information 1.1 How to Use this Manual This User Manual provides instructions for use and limitations on use for instruments and accessories used with the da Vinci SP® Surgical System model SP1098 (referred to in this manual as da Vinci SP System). It is not a reference for surgical techniques. This User Manual is to be used in conjunction with the da Vinci SP System User Manual, da Vinci SP Reprocessing Instructions for Accessories, da Vinci SP Reprocessing Instructions for Instruments, da Vinci SP Reprocessing Instructions for Camera, and da Vinci SP Reprocessing Instructions Appendices.

  • Page 8: Non-Sterile

    Knowing What Applies: Organization of this Manual • Chapter 1 General Information (the chapter you are reading now) applies to all da Vinci SP instruments and accessories supplied by Intuitive Surgical. Includes general precautions. • Chapter 2 EndoWrist SP Camera provides general information for the EndoWrist SP®...

  • Page 9: Contact Information

    1.800.876.1310, where phones are staffed 24 hours a day, seven days a week. In Europe, call +41.21.821.2020. If you have questions regarding the use, cleaning, sterilizing or storing of Intuitive Surgical devices used with the da Vinci SP System, contact Intuitive Surgical Customer Service at the phone number above. 1.3 Limitation on Use: Limited License...

  • Page 10: General Warnings And Cautions

    SP Cannula Seal, or EntryGuide™ (also known as Entry Guide), are installed during reprocessing. CAUTION: Use only the instruments and accessories approved by Intuitive Surgical. System compatibility with non-approved instrumentation cannot be guaranteed. CAUTION: EndoWrist SP instruments and accessories should be handled and operated by trained personnel.

  • Page 11: Disposal

    General Information Disposal When disposing of Intuitive Surgical instruments, accessories, or any of their components, follow all applicable national and local laws and guidelines. Do not dispose of cameras. _______________________________End of section_______________________________ da Vinci SP Instruments and Accessories...

  • Page 12: Endowrist Sp Camera

    EndoWrist SP Camera EndoWrist SP Camera 2.1 Introduction This chapter contains general information for the EndoWrist SP® Camera (also referred to as endoscope) and da Vinci SP® Camera Sheath. For further information on the camera, refer to the da Vinci SP System User Manual. Intended Use For intended use of the camera and associated accessories, see Appendix D: Intended Use...

  • Page 13: Device Description

    EndoWrist SP Camera Device Description The camera is an articulated instrument that includes a small stereo three-dimensional (3D) camera with a 73-degree field-of-view (FOV) located at the distal end of the shaft. The camera acquires 3D video from the surgical site in high definition (HD). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen.

  • Page 14: Preoperative Preparation

    EndoWrist SP Camera 2.2 Preoperative Preparation Inspection Before Use WARNING: Do not use cameras with any defects or signs of damage, including damage to the glass surface at the cable connector end, glass surface at the distal tip, or cables. Serious injury or surgical complications may occur to the patient. WARNING: Do not use a camera that has been reprocessed with a sheath installed.

  • Page 15: Camera Sheath Installation

    EndoWrist SP Camera Camera Sheath Installation WARNING: Inspect the Camera Sheath for damage throughout use. Examples of damage include tears or cuts in the sheath material. If damage is observed, remove and replace the Camera Sheath to prevent thermal hazards or other risks. CAUTION: All EndoWrist SP surgical instruments and the camera must be covered with sheaths designed specifically for use with the da Vinci SP System before surgical use.
  • Page 16 EndoWrist SP Camera 3. Press down the connector on the sheath until it is over the flanges on the base of the camera shaft, and there is a tactile and audible click (Figure 2.4). Flange (one on each side) Connector over flanges Figure 2.4 Connector over the flanges on the base of instrument shaft 4.

  • Page 17: Intraoperative Use

    EndoWrist SP Camera Figure 2.7 Examples of incorrect installation (A and B) and correct installation (C) 2.3 Intraoperative Use For information on intraoperative use (installation, insertion, and removal of the camera), refer to the da Vinci SP System User Manual. 2.4 Postoperative Instructions Camera Sheath Removal CAUTION: Use caution when installing and removing the sheaths to avoid camera...

  • Page 18: Disposal

    When disposing of Intuitive Surgical instruments, accessories, or any of their components, follow all applicable national and local laws and guidelines. Do not dispose of cameras. Contact Intuitive Surgical Customer Service to exchange expired cameras. Note: For more information on reprocessing the camera, refer to the da Vinci SP Reprocessing Instructions.

  • Page 19: Endowrist Sp Instruments

    EndoWrist SP Instruments EndoWrist SP Instruments 3.1 Introduction This chapter contains general instructions for use specific to the EndoWrist SP® instruments (also referred to as 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.

  • Page 20: Device Description

    Note: Instruments and accessories contain metal components. Ensure that patients do not have metal allergies. Note: Use only EndoWrist SP instruments. Other Intuitive Surgical instruments are not compatible with the da Vinci SP system. EndoWrist SP instruments are multiple-use endoscopic instruments to be used only in conjunction with the da Vinci SP System.

  • Page 21: Device Overview

    EndoWrist SP Instruments Table 3-2 EndoWrist SP Instrument Accessories Description/Name Part Number (PN) MCS Tip 430035 Cautery Hook Tip, 5 mm 400156 Cautery Spatula Tip, 5 mm 400160 Instrument Sheath 430012 EnergyShield Monopolar Cautery Cord 430068 Bipolar Cautery Cord 470384 Device Overview The EndoWrist SP instruments consist of the following components: •...

  • Page 22: Preoperative Preparation

    EndoWrist SP Instruments A. Instrument housing F. Shaft G. Tip E. Release buttons (one on each side) Close-up of instrument housing Close-up of instrument distal end H. Forearm J. Wrist B. Flush ports D. Cautery cord interface I. Elbow C. Grip Release Dial Figure 3.1 EndoWrist SP instrument 3.2 Preoperative Preparation Inspection Before Use...

  • Page 23: Da Vinci Sp Instrument Sheath Overview

    EndoWrist SP Instruments da Vinci SP Instrument Sheath Overview The da Vinci SP® Instrument Sheath (Figure 3.2) is specifically designed to cover the EndoWrist SP instruments and must be installed on the instruments prior to surgical use. The Instrument Sheath is supplied sterile and is for single use only; do not reuse the sheath. Install the sheath onto instruments before installing instrument tip accessories (Hook, Spatula and MCS Tip).
  • Page 24 EndoWrist SP Instruments 1. Remove the Instrument Sheath from the sterile packaging using sterile technique. 2. Straighten the instrument shaft (Figure 3.3 A) and fully close instrument jaws (if applicable). Slide the connector end of the sheath onto the shaft (Figure 3.3 Connector end of sheath...
  • Page 25 EndoWrist SP Instruments Instruments with permanent tips: • Confirm that the horizontal line below the IS logo on the instrument tip is visible just above the end of the sheath to ensure proper seating (Figure 3.6 End of End of sheath sheath incorrectly...

  • Page 26: Intraoperative Use

    EndoWrist SP Instruments Note: Refer to individual instrument chapters for further instrument preparation instructions. 3.3 Intraoperative Use For information on intraoperative use (installation, insertion, and removal of the instruments), refer to the da Vinci SP System User Manual. 3.4 Postoperative Instructions Remove the monopolar cautery tip and MCS Tip before removing the instrument sheath.

  • Page 27: Disposal

    3. Dispose of the sheath. Do not reuse the sheath on another instrument. Disposal When disposing of Intuitive Surgical instruments, accessories, or any of their components, follow all applicable national and local laws and guidelines. Do not dispose of cameras.

  • Page 28: Medium-Large Clip Applier

    Medium-Large Clip Applier Medium-Large Clip Applier Note: For general instrument information, see Chapter 3, EndoWrist SP Instruments, starting on page 13. 4.1 Introduction This section contains instructions for use specific to the EndoWrist SP Medium-Large Clip Applier. Compatibility Information The EndoWrist SP Medium-Large Clip Applier compatibility with third-party products is shown Table 4-1.

  • Page 29: Preoperative Preparation

    4.2 Preoperative Preparation Use only the compatible Hem-o-lok Ligating Clips cartridge. Intuitive Surgical does not assume responsibility for unsatisfactory results caused by the use of any instrument and clip that are not compatible. For information on compatible clips, refer to Table 4-1.

  • Page 30: Intraoperative Use

    Medium-Large Clip Applier 4.3 Intraoperative Use CAUTION: Do not attempt to close the jaws down on a vessel or anatomic structure without a clip properly loaded into the jaws. Closure of empty jaws on a vessel or structure may result in patient injury. 1.

  • Page 31: Monopolar Curved Scissors

    Curved Scissors intraoperatively. Twisting may cause the MCS Tip to loosen. WARNING: If damage or other flaws are observed on the instrument, do not use the instrument. Contact Intuitive Surgical Customer Service. In the U.S., call +1.800.876.1310. Examples of damage include: •...

  • Page 32: Preoperative Preparation

    Monopolar Curved Scissors 5.2 Preoperative Preparation This section describes information specific to installing the MCS Tip. Refer to Preoperative Preparation on page 16, for general preoperative instrument information. WARNING: Inspect the MCS Tip periodically during use. If any damage or tears are observed, replace the MCS Tip with a new one and continue to use the instrument.
  • Page 33 Monopolar Curved Scissors 2. Rotate the Grip Release Dial on the instrument housing clockwise to extend the pin from the distal end of the instrument shaft. Identify the white stripe on the instrument shaft (Figure 5.4 A and B). Pin socket White stripe Figure 5.4 Extend pin from instrument tip and identify white stripe (A and B) 3.
  • Page 34 Monopolar Curved Scissors 5. With one hand grasping the tip cover and the other hand stabilizing the instrument joints, push the tip cover down until it is flush with instrument sheath and rotate ¼ turn clockwise until there is a tactile click to lock in place (Figure 5.7 A and B).

  • Page 35: Intraoperative Use

    Monopolar Curved Scissors 5.3 Intraoperative Use This section describes information specific to troubleshooting the MCS Tip. Refer to Monopolar Instruments and EnergyShield Monitor Use on page 47, for full intraoperative use information. MCS Tip Troubleshooting CAUTION: If the MCS Tip becomes loose during use DO NOT use another instrument to remove the accessory inside the patient.

  • Page 36: Disposal

    Monopolar Curved Scissors 2. Stabilize the instrument joints and grasp the tip cover. Rotate the tip cover ¼ turn counter-clockwise to unlock from the instrument shaft (Figure 5.11). If needed, use sterile gauze to more firmly grasp the tip cover while rotating. Figure 5.11 Grasp the tip cover and rotate ¼...

  • Page 37: Monopolar Cautery Instrument

    WARNING: Do not re-use or re-sterilize the hook tip or spatula tip. WARNING: If damage or other flaws are observed on the instrument, do not use the instrument. Contact Intuitive Surgical Customer Service. In the U.S., call +1.800.876.1310. Examples of damage include: •...

  • Page 38: Preoperative Preparation

    Monopolar Cautery Instrument 6.2 Preoperative Preparation This section describes information specific to installing the monopolar cautery tip. Refer to Preoperative Preparation on page 16, for general preoperative instrument information. WARNING: Inspect the hook tip or spatula tip periodically during use. If any damage or tears are observed, replace the monopolar cautery tip with a new one and continue to use the instrument.
  • Page 39 Monopolar Cautery Instrument Figure 6.3 Straighten instrument shaft 3. Grasp the monopolar cautery tip installation tool, align and insert the metal electrode on the monopolar cautery tip into the slot on the instrument tip while stabilizing the instrument joints (Figure 6.4).

  • Page 40: Intraoperative Use

    Monopolar Cautery Instrument Properly connected monopolar cautery tip Monopolar cautery tip plastic component plastic component Figure 6.5 Rotate the plastic component of the monopolar cautery tip (A), and confirm it is properly connected (B) 5. Pull up on the installation tool to remove it from the monopolar cautery tip (Figure 6.6 A and B).

  • Page 41: Disposal

    Monopolar Cautery Instrument CAUTION: Do not attempt to remove the monopolar cautery tip by turning the metal electrode by hand or with an instrument. This will damage the instrument. Always remove the monopolar cautery tip by unscrewing the plastic component of the monopolar cautery tip manually.

  • Page 42: Bipolar Instruments

    Bipolar Instruments Bipolar Instruments Note: For general instrument information, see Chapter 3, EndoWrist SP Instruments, starting on page 13. 7.1 Introduction The EndoWrist SP bipolar instruments are multiple-use, electrosurgical endoscopic instruments. They are designed to be used in conjunction with the da Vinci SP System and the electrosurgical unit (ESU).

  • Page 43: Introduction

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments 8.1 Introduction The following sections contain information regarding use of the integrated electrosurgical unit (ERBE VIO® dV 2.0), EnergyShield® Monitor, set up and use of the monopolar and bipolar cautery instruments and troubleshooting.
  • Page 44 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments WARNING: Do not use one instrument to energize the tips of another instrument (robotic or manual laparoscopic). This may cause patient injury and damage to the instrument. Energy may flow to the patient from places other than the tip, inside or outside the field of view.

  • Page 45: Integrated Erbe Vio Dv 2.0

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments CAUTION: To avoid inadvertent thermal damage to surrounding tissue and other hazards, observe the following. • Ensure that the patient neutral pad is securely affixed to the patient, placed as close as possible to the operating field, and properly connected to the electrosurgical unit.

  • Page 46: Vio Dv Overview

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments VIO dV Overview ESU Screen Features • Power button: The button that turns the ESU on/off. • Volume control: Up/down selection buttons that adjust the volume settings. • Recall: A button that displays when the ESU is first powered on that enables use of previous ESU settings.
  • Page 47 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Note: The VIO dV auxiliary foot pedals (bipolar and monopolar) are connected to the VIO dV and are located in the bottom drawer of the Vision Cart. Assignment indicators (bipolar) Bipolar mode pod COAG Bipolar port 1...

  • Page 48: Selecting Vio Dv Settings

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Selecting VIO dV Settings After the VIO dV is powered on, the default effect settings will be zero and must be increased to activate energy. Settings can be selected by recalling previous monopolar and bipolar settings, or by manually adjusting the settings.

  • Page 49: Bipolar And Monopolar Instrument Activation

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Mode selection Effect selection Figure 8.5 Mode and effect settings, Monopolar COAG Bipolar and Monopolar Instrument Activation Bipolar and monopolar instruments (EndoWrist SP and manual) can be activated using the specified ports (as shown with [X] in the tables below).
  • Page 50 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Power Limit button Effect selection Power Limit selection Figure 8.6 Power limit settings, Monopolar COAG example Power limit settings can also be adjusted on the Surgeon Console touchpad. For instructions, see the da Vinci SP System User Manual.

  • Page 51: Control Assignment Indicators

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Control Assignment Indicators The control assignment indicators (also referred to as assignment indicators) contain icons that specify how the instruments connected to the ports can be activated. Each port is associated with the adjacent assignment indicator (as shown in Figure 8.7).
  • Page 52 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Assignment Indicator Icon Descriptions The following table describes the icons that appear in the monopolar and bipolar control assignment indicators. Table 8-4 Control Assignment Indicator Icons Icon Meaning Good EndoWrist SP instrument connection (monopolar or bipolar) An EndoWrist SP instrument is connected to the port and installed on an instrument drive.

  • Page 53: Erbe Vio Dv 2.0 Fault Conditions

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments ERBE VIO dV 2.0 Fault Conditions Four ERBE VIO dV 2.0 fault conditions related to da Vinci SP energy instruments result in system messages displayed on the Vision Cart touchscreen, above the instrument status pod, and in the 3D viewer.
  • Page 54 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments WARNING: Do not touch the tips while electrosurgical energy is activated as this may cause severe electrical injury and/or burn to the user. WARNING: The patient neutral pad must be properly affixed to the patient before the use of monopolar cautery, to prevent patient or operator injury.

  • Page 55: Energyshield Monopolar Cautery Cord

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments EnergyShield Monopolar Cautery Cord The reusable EnergyShield Monopolar Cautery Cord (PN 430068) is intended to be used in conjunction with the VIO dV generator, EnergyShield Monitor and EndoWrist SP monopolar instruments with the appropriate connector (Figure 8.8).

  • Page 56: Energyshield Monitor Overview

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments EnergyShield Monitor Overview The EnergyShield Monitor provides monitoring of electrosurgical energy during use of EndoWrist SP monopolar instruments, which are shielded to reduce the risks of capacitive coupling. The EnergyShield Monitor terminates energy delivery when a fault condition is detected on the connected monopolar instrument, such as: •...
  • Page 57 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments 3. Verify that the neutral adapter from the EnergyShield Monitor is plugged into the neutral port on the VIO dV (Figure 8.10). Confirm that the connector cannot be pushed further into the neutral port.
  • Page 58 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments 6. Connect the patient neutral pad plug into the neutral receptacle on the EnergyShield Monitor (Figure 8.11). Verify that the Neutral Pad LED illuminates blue and the patient neutral pad icon on the VIO dV illuminates green. Patient Neutral Pad Figure 8.11 Patient pad plugged into EnergyShield Monitor WARNING: Do not bypass the EnergyShield Monitor while using EndoWrist SP...
  • Page 59 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Note: It is recommended to have a backup EndoWrist SP monopolar instrument available for use to minimize procedure delay in the event of an instrument-related EnergyShield Monitor fault. 8. Align the arrow on the wide connector end of the monopolar cautery cord with the arrow above the monopolar receptacle on the EnergyShield Monitor (Figure 8.13) and plug it in.

  • Page 60: Energyshield Monitor Faults And Failure

    EnergyShield Monitor fault. If at any time the EnergyShield Monitor does not function as described, discontinue use of the EnergyShield Monitor and contact Intuitive Surgical Customer Service. EnergyShield Monitor Faults If an EnergyShield Monitor fault can be resolved by the user, solid amber LED(s) on the...
  • Page 61 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Table 8-6 EnergyShield Monitor Faults EnergyShield Monitor EnergyShield Monitor Troubleshooting Steps Amber LED Status Neutral Pad Dual-surface patient Ensure that a dual-surface patient neutral pad is applied to the neutral pad not connected patient.

  • Page 62: Intraoperative Use

    8.19) which can be recovered to resume all system control modes and bipolar energy activation of the VIO dV, but energy activation of EndoWrist SP monopolar instruments will be prevented from the Surgeon Console. If this occurs, contact Intuitive Surgical Customer Service.

  • Page 63: Intraoperative Cleaning

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments CAUTION: If the MCS Tip becomes loose during use DO NOT use another instrument to remove the accessory inside the patient. Close the MCS blades, remove the instrument from the port, and replace the MCS Tip with a new one. Monopolar instruments are rated for a maximum peak voltage of 3kV (6kV peak-to-peak).
  • Page 64 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments CAUTION: Connect the ESU to the EndoWrist SP instrument using the appropriate monopolar/bipolar cord. Refer to the ESU’s manual for indications and instructions in making this connection. Monopolar cords may only be connected to monopolar ports, and bipolar cords to bipolar ports.

  • Page 65: Connecting Bipolar Instruments To The Vio Dv

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Connecting Bipolar Instruments to the VIO dV 1. Connect the energy cord to the EndoWrist SP instrument: Connect the instrument connector on the energy cord to the applicable EndoWrist SP instrument. The instrument connector is properly seated when it cannot be pushed further into the instrument housing.

  • Page 66: Intraoperative Cleaning

    Table 8-7 describes troubleshooting information to help you address energy delivery issues when using the EndoWrist SP monopolar and bipolar instruments. If troubleshooting does not resolve the energy delivery issue, contact Intuitive Surgical Customer Service. da Vinci SP Instruments and Accessories...
  • Page 67 Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Table 8-7 Troubleshooting Monopolar and Bipolar Instrument Energy Delivery Possible Problems Remedy Monopolar and Bipolar Instruments VIO dV not powered on or • Confirm that the VIO dV is powered on. mode effect not set •...

  • Page 68: Patient Neutral Pad Positioning

    Using the Electrosurgical Unit (ESU) with Monopolar and Bipolar Instruments Patient Neutral Pad Positioning It is possible to get patient neutral pad positioning errors on the VIO dV, especially when not using the ERBE patient neutral pads. For more information on proper patient neutral pad positioning, refer to the ERBE VIO dV User Manual.

  • Page 69: Da Vinci Sp Port Accessories

    da Vinci SP Port Accessories da Vinci SP Port Accessories 9.1 Introduction This section contains instructions for use specific to the da Vinci SP® port accessories (da Vinci SP Cannula, da Vinci SP Obturator, and EntryGuide™ Kit) used with the da Vinci SP System.

  • Page 70: Device Overview

    da Vinci SP Port Accessories Device Overview • SP Cannula: A stainless steel component (Figure 9.1) consisting of a SP Cannula fin, insufflation port, and hollow tube (lumen). Cannula Fin Insufflation port Figure 9.1 Example SP Cannula • EntryGuide Kit: The single-use EntryGuide Kit consists of the EntryGuide SP Cannula Insert (also referred to as Entry Guide) and EntryGuide SP Cannula Seal (also referred to as SP Cannula Seal).

  • Page 71: Preoperative Preparation

    Only a physician or medical personnel under the supervision of a physician should use Intuitive Surgical SP Cannulas and obturators. Before use, confirm that the SP Cannula and obturator have been appropriately sterilized and that the sterile packaging of the EntryGuide Kit is intact.
  • Page 72 da Vinci SP Port Accessories 1. Carefully inspect the SP Cannula visually for damage. Examples of damage include nicks or dents in the edge of the SP Cannula tube, and dents or flat spots in the SP Cannula tube that interfere with the free insertion of the Entry Guide. Figure 9.5 shows examples of SP Cannula damage and a SP Cannula that is not damaged.

  • Page 73: Using The Port Accessories

    da Vinci SP Port Accessories 9.4 Using the Port Accessories The following section describes general instructions for using the port accessories. Before using the accessories, remove them from the sterile packaging using sterile technique and keep them within the sterile field. WARNING: Follow the instructions in this section to ensure complete attachment of the SP Cannula Seal to the SP Cannula, and the Entry Guide or obturator to the SP Cannula/SP Cannula Seal assembly.
  • Page 74 da Vinci SP Port Accessories Attaching and Removing the Obturator Before attaching the obturator, ensure that a SP Cannula Seal is attached to the cannula. Insert the obturator fully into the SP Cannula Seal and through the SP Cannula until the latch on the SP Cannula Seal locks the obturator into place with a tactile and audible click (Figure 9.9).

  • Page 75: Disposal

    da Vinci SP Port Accessories To remove the Entry Guide, pull back the latch on the SP Cannula Seal and pull the Entry Guide out of the SP Cannula (Figure 9.12). Figure 9.12 Remove the Entry Guide from the SP Cannula Disposal Dispose of the single-use Entry Guide and SP Cannula Seal as biological hazardous waste and according to local hospital protocol.

  • Page 76: Room

    For full Reprocessing information, refer to the da Vinci SP Reprocessing Instructions. Note: Carefully remove all accessories, including disposable attachments, such as removable tips, before reprocessing. When disposing of Intuitive Surgical instruments, accessories, or components, follow institution biohazard protocol and all applicable national and local laws and guidelines. Prime and Soak...

  • Page 77: B Appendix B: Symbols Defined

    Appendix B: Symbols Defined Appendix B: Symbols Defined The following symbols may appear on instruments, accessories, and packaging labels. For a complete list of symbols and icons see the da Vinci SP System User Manual. Symbol or Icon Meaning Attention: Consult accompanying documents Federal (U.S.) law restricts this device for sale, Rx only distribution, and use by or on the order of a physician...
  • Page 78 Appendix B: Symbols Defined Symbol or Icon Meaning Version Quantity Batch Code Catalog Number Authorized representative in the European Community Electronic Instructions for Use Entry Guide Camera indicator Entry Guide and SP Cannula Seal Size indicator Entry Guide Camera and Lumen icon Camera Leak Test Port icon Camera Laser Aperture icon Must be sterilized only by autoclave...
  • Page 79 Appendix B: Symbols Defined Symbol or Icon Meaning Device is not designated for human use Number of times the instrument can be used Number of closures that can be used with the clip applier _________________________________End of section______________________________ da Vinci SP Instruments and Accessories...

  • Page 80: C Appendix C: Natural Rubber Latex

    Appendix C: Natural Rubber Latex Appendix C: Natural Rubber Latex For the following Intuitive Surgical products containing elastomeric/pliable parts and referenced in this manual, materials that are intended to contact users or patients during normal use and handling are not made with natural rubber latex: •...

  • Page 81: D Appendix D: Intended Use Statements

    Appendix D: Intended Use Statements Appendix D: Intended Use Statements The following intended use statements apply to the da Vinci SP instruments and accessories. For information on specific indications for use and representative uses of the da Vinci SP Surgical System, refer to the appropriate da Vinci SP supplement. Product Part Number Intended Use...
  • Page 82 Appendix D: Intended Use Statements Product Part Number Intended Use The Instrument Sheath is intended to be used with the EndoWrist SP surgical instruments to reduce ingress of biological material into the instrument, allow smooth insertion and retraction through the Entry Instrument Sheath 430012 Guide, and provide electrical insulation over the shaft and joints of...

  • Page 83: E Appendix E: Sterilization Methods

    Appendix E: Sterilization Methods Appendix E: Sterilization Methods This table describes sterilization methods used for single-use Intuitive Surgical products referenced in this manual. Name Part Number Method Camera Sheath 430020 Ethylene Oxide Instrument Sheath 430012 Ethylene Oxide MCS Tip 430035...

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