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Appendix C: Natural Rubber Latex

da Vinci SP Instruments and Accessories

AFT/PRE-RELEASE/C

ONFIDENTIAL

12/5/19

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:

• EndoWrist SP Camera (PN 430060)

• MCS Tip and installation tool (PN 430035)

• Cautery Hook Tip, 5 mm (PN 400156)

• Cautery Spatula Tip, 5 mm (PN 400160)

• EntryGuide Kit C.6.6.6, 25 mm x 100 mm (PN 430022)

• EnergyShield Monopolar Cautery Cord (PN 430068)

• Bipolar Cautery Cord (PN 470384)

• Instrument Sheath (PN 430012)

• Camera Sheath (PN 430020)

_______________________________End of section_______________________________

Содержание DAVINCI XP

Страница 1: ...Intuitive Surgical S rl Chemin des M riers 1 1170 Aubonne Switzerland Intuitive Surgical Inc 1266 Kifer Road Sunnyvale CA 94086 USA intuitive com Instruments and Accessories User Manual PN 553415 03...

Страница 2: ...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 Surgic...

Страница 3: ...ween Uses 4 Disposal 5 2 EndoWrist SP Camera 6 2 1 Introduction 6 Intended Use 6 General Warnings and Cautions 6 Device Description 7 2 2 Preoperative Preparation 8 Inspection Before Use 8 da Vinci SP...

Страница 4: ...5 1 Introduction 25 General Warnings and Cautions 25 5 2 Preoperative Preparation 26 MCS Tip Overview 26 Install the MCS Tip 26 5 3 Intraoperative Use 29 MCS Tip Troubleshooting 29 5 4 Postoperative...

Страница 5: ...Shield Monopolar Cautery Cord 49 EnergyShield Monitor Overview 50 Connecting the Monopolar Instruments EnergyShield Monitor and VIO dV 50 EnergyShield Monitor Faults and Failure 54 Intraoperative Use...

Страница 6: ...12 5 19 A Appendix A Reprocessing Preparation in the Operating Room 70 Prime and Soak 70 Transport to Sterile SPD or CSSD 70 B Appendix B Symbols Defined 71 C Appendix C Natural Rubber Latex 74 D App...

Страница 7: ...als provide additional information specific to the types of surgical procedures that are cleared for a particular market For information on specific types of surgical procedures refer to the appropria...

Страница 8: ...ents including Instrument Sheath installation and removal instructions Chapter 4 Medium Large Clip Applier provides specific instrument information and instructions for use Chapter 5 Monopolar Curved...

Страница 9: ...above 1 3 Limitation on Use Limited License Intuitive Surgical da Vinci SP instruments and accessories are provided pursuant to a limited license to use only with the Intuitive Surgical da Vinci SP Sy...

Страница 10: ...essing and or reuse of products intended for single use only may result in degraded instrument performance or loss of functionality and in exposure to viral bacterial fungal or prionic pathogens CAUTI...

Страница 11: ...ONFIDENTIAL 12 5 19 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 came...

Страница 12: ...ry Guide are installed during reprocessing WARNING The EndoWrist SP camera and instruments must be used with the appropriate SP Cannula SP Cannula Seal and Entry Guide Refer to Chapter 9 da Vinci SP P...

Страница 13: ...ectronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen The surgeon controls the camera with a single hand control master The camera does not feature sh...

Страница 14: ...erior of the device for cleanliness paying special attention to the tip There should be no visual contamination of the device for example adherent soil If the device has any residual contamination do...

Страница 15: ...led on a camera or instrument do not reuse the sheath on another camera or instrument CAUTION Use caution when installing and removing the sheaths to avoid camera shaft elbow or wrist damage Use glove...

Страница 16: ...ack band on the distal end of the sheath as shown in Figure 2 5 Slide the black band down until your thumb contacts the camera lens and the band is past the distal ridge Figure 2 5 Hold thumb over bla...

Страница 17: ...ser Manual 2 4 Postoperative Instructions Camera Sheath Removal CAUTION Use caution when installing and removing the sheaths to avoid camera shaft elbow or wrist damage Use gloves with sufficient grip...

Страница 18: ...r less slippery gloves may be used to more firmly grasp the sheath while twisting Figure 2 9 Pinch the black band then twist and push Disposal When disposing of Intuitive Surgical instruments accessor...

Страница 19: ...e sterilization may occur when these single use accessories such as the MCS Tip monopolar cautery tip sheath SP Cannula Seal or EntryGuide also known as Entry Guide are installed during reprocessing W...

Страница 20: ...lly opened by first pressing the instrument disengage button on the instrument drive and then turning the Grip Release Dial on the instrument housing to release the grips from tissue For troubleshooti...

Страница 21: ...buttons located on each side of the housing are used to release the instrument from the sterile adapter Shaft Figure 3 1 F The shaft inserts through the EntryGuide SP Cannula Insert also referred to...

Страница 22: ...laparoscopic endoscopic instruments This may be done visually under magnification Before use all instruments should be visually inspected for damage or irregularities Do not use the instrument if dam...

Страница 23: ...in the sheath material If damage is observed remove and replace the Instrument Sheath on any instrument monopolar or other to prevent stray cautery or other risks CAUTION The camera and instruments mu...

Страница 24: ...onto the shaft B 3 Pull the sheath down the shaft toward the instrument housing Press down the connector end of the sheath until it is over the flanges on the base of the instrument shaft and there is...

Страница 25: ...ble tips Confirm that the instrument tip connector is fully visible to ensure proper seating on the end of the sheath Figure 3 7 B and Figure 3 8 B Figure 3 7 Instrument Sheath incorrectly A and corre...

Страница 26: ...eath For monopolar cautery tip removal instructions see 6 4 Postoperative Instructions on page 34 For MCS Tip removal instructions see 5 4 Postoperative Instructions on page 29 Instrument Sheath Remov...

Страница 27: ...3 10 Slide sheath toward distal end of instrument shaft A and pinch and gently twist the sheath tip B 3 Dispose of the sheath Do not reuse the sheath on another instrument Disposal When disposing of...

Страница 28: ...ications found with the Hem o lok Ligating Clips apply when clips are applied with the EndoWrist SP Medium Large Clip Applier Indications Hem o lok Ligating Clips are intended for use in procedures in...

Страница 29: ...e use of other surgical devices in the immediate area of the application 4 2 Preoperative Preparation Use only the compatible Hem o lok Ligating Clips cartridge Intuitive Surgical does not assume resp...

Страница 30: ...or cause the clip to fall out of the instrument altogether when the surgeon opens the hand control after a small closure of the hand control 2 After the instrument is inserted past the SP Cannula and...

Страница 31: ...y may result in Imprecise tip movement MCS Tip falling off Electrical arcs and alternate site burns WARNING Use care not to twist the MCS Tip when carefully cleaning the Monopolar Curved Scissors intr...

Страница 32: ...olar Curved Scissors Tip MCS Tip is designed for use with the Monopolar Curved Scissors and must be installed prior to surgical use The MCS Tip with installation tool Figure 5 1 is provided in a steri...

Страница 33: ...l end of the MCS Tip into the pin socket Figure 5 5 B and C Figure 5 5 Grasp installation tool B and insert ball end of MCS Tip into pin socket C 4 Rotate the installation tool to align the black stri...

Страница 34: ...actile click to lock in place Figure 5 7 A and B Figure 5 7 Push tip cover down A then rotate turn clockwise B 6 Remove the installation tool from the MCS Tip Figure 5 8 If desired retain the installa...

Страница 35: ...ssociated hand control 2 Use the hand control to approximately straighten the instrument joints Patient side assistant 3 Retract the camera to visualize instrument removal 4 Under endoscopic vision cl...

Страница 36: ...sp the tip cover and rotate turn counter clockwise to unlock from the instrument shaft 3 Rotate the Grip Release Dial on the instrument housing clockwise to extend the pin from the distal end of the i...

Страница 37: ...ws 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 Cracks deformations or burn marks on t...

Страница 38: ...Tip Overview The single use monopolar cautery tip hook tip and spatula tip is designed for use with the Monopolar Cautery Instrument and must be installed prior to surgical use Figure 6 1 The hook tip...

Страница 39: ...ion tool around the plastic component of the monopolar cautery tip and rotate clockwise until it is secure Figure 6 5 A and B Visually confirm that there is no gap between the monopolar cautery tip pl...

Страница 40: ...ure 6 6 Pull up on installation tool to remove from monopolar cautery tip A and B 6 3 Intraoperative Use Refer to Monopolar Instruments and EnergyShield Monitor Use on page 47 for intraoperative use i...

Страница 41: ...t of the monopolar cautery tip Figure 6 7 Figure 6 7 Reapply the installation tool 2 Stabilize the instrument joints Hold the installation tool around the plastic component of the monopolar cautery ti...

Страница 42: ...tion with the da Vinci SP System and the electrosurgical unit ESU Refer to 3 2 Preoperative Preparation on page 16 for general preoperative instrument information and 3 4 Postoperative Instructions on...

Страница 43: ...electronic implants such as cardiac pacemakers without first consulting a qualified professional for example a cardiologist A possible hazard exists because interference with the action of the electro...

Страница 44: ...tral pad grounding pad and their connections Use the active electrode or forceps only for the minimum time necessary to achieve the desired surgical effect in order to minimize the possibility of burn...

Страница 45: ...taneously on the same patient Do not use flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen Use only non flammable agents for cleaning and disinfecting If flammable agents are u...

Страница 46: ...t manual monopolar instruments and the EnergyShield Monitor to the ESU See Connecting the Monopolar Instruments EnergyShield Monitor and VIO dV on page 50 for more information Neutral port The port us...

Страница 47: ...ress the Power button on the lower left side of the VIO dV to turn it on The Loading screen appears Main Screen The Main screen displays the default settings shown in Figure 8 2 Figure 8 2 Main screen...

Страница 48: ...touch the Recall button The Recall button disappears and the previous settings are applied The settings can then be used or manually adjusted as needed Figure 8 3 Figure 8 3 Recall button Manually Adj...

Страница 49: ...the potential range of power fluctuation 1 Touch the Power Limit button to open the power limit settings window 2 Use the left and right arrow buttons to select the required limit The power limit can...

Страница 50: ...the Surgeon Console touchpad For instructions see the da Vinci SP System User Manual Presets On the Surgeon Console touchpad users can save up to three preferred sets of energy settings presets to an...

Страница 51: ...or as shown in Figure 8 7 If an EndoWrist SP instrument is connected to the associated port the icon indicates the following whether or not the instrument is completely connected and if connected the...

Страница 52: ...n an instrument drive Bipolar The EndoWrist SP instrument is installed on an instrument drive but is not connected to the VIO dV or The EndoWrist SP instrument is connected to the VIO dV but is not in...

Страница 53: ...tic 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 Avoid close prox...

Страница 54: ...failure of the device to function correctly at the normal operating settings may indicate faulty application of the patient neutral pad or poor contact in its connections WARNING Loss of safe contact...

Страница 55: ...8 8 The cord is supplied non sterile and requires cleaning and sterilization before use For more information regarding cleaning and sterilization refer to the Reprocessing Instructions Figure 8 8 Ene...

Страница 56: ...sks For more information on troubleshooting the EnergyShield Monitor see EnergyShield Monitor Faults and Failure on page 54 Connecting the Monopolar Instruments EnergyShield Monitor and VIO dV This se...

Страница 57: ...EnergyShield Monitor can remain plugged into the neutral port on the VIO dV to enable use of manual instruments with the VIO dV even in the event of an EnergyShield Monitor fault Note Only monopolar p...

Страница 58: ...ass the EnergyShield Monitor while using EndoWrist SP monopolar instruments by connecting the patient neutral pad directly to the ESU ESU operation is prevented if the patient neutral pad is not conne...

Страница 59: ...ctor cannot be pushed further into the receptacle When both ends of the monopolar cautery cord are properly connected to the EndoWrist SP monopolar instrument and EnergyShield Monitor the cord LED on...

Страница 60: ...iliary foot pedal activated is permitted All system control modes including Following mode for installed instruments remain available during an EnergyShield Monitor fault If at any time the EnergyShie...

Страница 61: ...ection interrupted Connect the monopolar cautery cord to the monopolar instrument installed on the da Vinci SP System and to the monopolar receptacle of the EnergyShield Monitor a If fault persists re...

Страница 62: ...ng effects are observed excessive arcing excessive tissue charring excessive overheating of the tip for example the tip glowing red or emitting a blue plasma cloud WARNING Exercise caution when workin...

Страница 63: ...s or other unintended consequences such as disconnection of the instrument tip To clean an instrument intraoperatively remove the instrument from the system and wipe the instrument tip with moist ster...

Страница 64: ...e Description The reusable Bipolar Cautery Cord PN 470384 is designed to be used as an accessory to the EndoWrist SP bipolar instruments in conjunction with the VIO dV generator during surgical and ot...

Страница 65: ...t to any staples clips or sutures while energized Damage to the end effectors may occur WARNING Do not attempt to scrape off carbonized tissue with a sharp object such as a scalpel WARNING Do not use...

Страница 66: ...uences such as disconnection of the instrument tip To clean an instrument intraoperatively remove the instrument from the system and wipe the instrument tip with moist sterile gauze CAUTION Keep the a...

Страница 67: ...sabled Confirm the following The VIO dV is connected to the da Vinci SP System and powered on The foot pedals are enabled The mode effect setting is higher than zero Effect settings default to zero Th...

Страница 68: ...ENTIAL 12 5 19 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 o...

Страница 69: ...OT RE STERILIZE DO NOT RE USE Reprocessing and or reuse of products intended for single use only may result in degraded instrument performance or loss of functionality and in exposure to viral bacteri...

Страница 70: ...terile single use and disposable and guides the instrument and camera shafts through the SP Cannula and allows rotation of the instrument drives relative to the SP Cannula The Entry Guide consists of...

Страница 71: ...ure 9 4 Example obturator 9 3 Preoperative Preparation Only a physician or medical personnel under the supervision of a physician should use Intuitive Surgical SP Cannulas and obturators Before use co...

Страница 72: ...isible cracks or other damage 2 Insert the obturator into the SP Cannula to inspect the inner diameter of the SP Cannula Figure 9 6 A and B If the obturator cannot be inserted smoothly through the SP...

Страница 73: ...Entry Guide as loss of insufflation may result Note The SP Cannula must be used with the SPCannula Seal and Entry Guide Do not insert a camera or instruments through a SP Cannula without a SP Cannula...

Страница 74: ...Figure 9 9 Obturator attached to SP Cannula Seal To remove the obturator pull back the latch on the SP Cannula Seal and gently pull the obturator out of the SP Cannula Figure 9 10 Figure 9 10 Remove...

Страница 75: ...h 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...

Страница 76: ...ocedure Intuitive Surgical recommends starting immediately after the procedure to avoid drying of residual soil on devices Prime the instrument using a syringe with a Luer fitting to fill the Primary...

Страница 77: ...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 distribution and use by...

Страница 78: ...nstructions 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 steriliz...

Страница 79: ...PRE RELEASE CONFIDENTIAL 12 5 19 _________________________________End of section______________________________ Device is not designated for human use Number of times the instrument can be used Number...

Страница 80: ...to contact users or patients during normal use and handling are not made with natural rubber latex EndoWrist SP Camera PN 430060 MCS Tip and installation tool PN 430035 Cautery Hook Tip 5 mm PN 400156...

Страница 81: ...d with the da Vinci SP System for manipulating cutting and dissecting tissue coagulating and transecting tissue using monopolar electrosurgical energy and cutting suture The MCS Tip is also intended t...

Страница 82: ...ntry Guide and provide electrical insulation over the shaft and joints of the EndoWrist SP surgical instruments to reduce the likelihood of unintended electrosurgical energy delivery Camera Sheath 430...

Страница 83: ...l products referenced in this manual _________________________________End______________________________ Name Part Number Method Camera Sheath 430020 Ethylene Oxide Instrument Sheath 430012 Ethylene Ox...

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