da Vinci Xi Accessories Reprocessing Instructions

Copyright © 2021 Intuitive Surgical Operations, Inc. All rights reserved. Trademarks Intuitive, Intuitive Surgical, da Vinci Xi, EndoWrist, and Single-Site are trademarks or registered trademarks of Intuitive Surgical. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner. See www.intuitive.com/trademarks.

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Reprocessing Manual for da Vinci Xi Accessories

Table of Contents INTRODUCTION

Symbols: Warnings, Cautions, and Notes General Warnings, Cautions, and Notes Text Glossary Symbol Glossary Overview of Accessory Groups

GROUP 1

7 7 8 10 11 13

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Cannulae, Obturators, Release Kits, Hasson Cone, Instrument Introducers, Gage Pins, Suction Irrigator Kit, and others (see Reprocessing Instructions Appendices PN 554154 for complete list) Accessories Group 1 Overview Automated Cleaning Process Overview Manual Cleaning Process Overview

17 18 19

Operating Room (OR)...21 Remove Accessories 23 Wipe 23 Wet 24 Chemical Pre-Disinfection 25 Transport 26 Dirty Side, Automated Cleaning...27 Remove Accessories 29 Prepare Solution 30 Soak 31 Rinse 31 Brush 32 Final Rinse 32 Inspect 33 Automated Cleaning 33 Transfer 34

Reprocessing Manual for da Vinci Xi Accessories

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Table of Contents (continued) Dirty Side, Manual Cleaning...35 Remove Accessories 37 Prepare Solution 38 Soak 39 Rinse 39 Brush 40 Ultrasonic Cleaning 41 Final Rinse 43 Inspect 43 Thermal Disinfection 44 Transfer 44 Clean Side...45 Dry 47 Final Inspection 47 Sterilization Warnings, Cautions, and Notes 49 Pack 50 Sterilization Process Parameters 51 Wrap or Prepare 52 Sterilize 53 Store 53

GROUP 2

55

Cords (see Reprocessing Instructions Appendices PN 554154 for complete list) Accessories Group 2 Overview Automated Process Overview Manual Process Overview

57 58 59

Operating Room (OR)...61 Disconnect Cords 62 Chemical Pre-Disinfection 63 Transport 64 Dirty Side, Automated Cleaning...65 Remove Accessories 67 Prepare Solution 67 Wipe 68 Inspect 69 Automated Cleaning 69 Transfer 70 4

Reprocessing Manual for da Vinci Xi Accessories

Table of Contents (continued) Dirty Side, Manual Cleaning...71 Remove Accessories 73 Prepare Solution 74 Wipe 75 Brush 75 Ultrasonic Cleaning 76 Final Rinse 78 Inspect 78 Thermal Disinfection 79 Transfer 79 Clean Side...81 Dry 83 Final Inspection 84 Sterilization Warnings, Cautions, and Notes 85 Pack 86 Sterilization Process Parameters 87 Wrap or Prepare 88 Sterilize 89 Store 89

GROUP 3

Xi Endoscope Trays Accessories Group 3 Overview Automated Process Overview Manual Process Overview

91 93 94 95

Operating Room (OR)...97 Wipe 99 Chemical Pre-Disinfection 99 Transport 100 Dirty Side, Automated Cleaning... 101 Wipe 103 Inspect 103 Pack 104

Reprocessing Manual for da Vinci Xi Accessories

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Table of Contents (continued) Dirty Side, Manual Cleaning... 105 Prepare Solution 107 Wipe 108 Brush 108 Final Rinse 109 Inspect 109 Thermal Disinfection 110 Transfer 110 Clean Side... 111 Dry 113 Final Inspection 114 Sterilize 115

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Reprocessing Manual for da Vinci Xi Accessories

Introduction

INTRODUCTION

These Instructions for Use contain the cleaning, disinfection, and sterilization instructions and parameters recommended by Intuitive Surgical. These instructions apply to da Vinci Xi® Accessories. These instructions contain essential information for reprocessing accessories. Read these instructions in their entirety before reprocessing the accessories. Reusable accessories are not supplied sterile and must be reprocessed prior to first use. If there are any questions or comments about any information in these instructions, or if a problem occurs while reprocessing that cannot be resolved, contact Intuitive Surgical.

Symbols: Warnings, Cautions, and Notes

The most frequently used symbols in these instructions are provided below. See Appendix A for a complete list of symbols.

WARNING Alerts the reader about a situation which, if not avoided, could result in death or serious injury. 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. NOTE Highlights important information.

Reprocessing Manual for da Vinci Xi Accessories

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INTRODUCTION

General Warnings, Cautions, and Notes WARNING • Devices are to be handled, reprocessed, and operated by qualified and trained personnel only. Inadequate training may result in device damage or patient/operator harm. • Cleaning processes described in these instructions have been validated by Intuitive Surgical. Alternative cleaning processes may result in incomplete reprocessing, which may lead to patient harm. • Do not reuse or reprocess single-use devices after being removed from package, even if unused, as this may result in incomplete sterilization and/or device damage, which may lead to patient harm. • Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated devices. Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated devices, to prevent operator injury. PPE includes: gloves, gown, mask, goggles or face shield and shoe covers. • Use only the validated sterilization machines, parameters, and cycles, and follow instructions in entirety. Any other cycles and parameters have not been validated and may damage the device, or may result in incomplete sterilization, which may lead to patient harm. • Exercise care while handling devices with sharp points or cutting edges. Failure to follow Universal Precautions could result in injury. • Use care in handling chemicals and contaminated solutions, as skin contact, inhalation, or ingestion may cause injury. • Prior to use, after use, or during reprocessing, always inspect devices for any defects or damage. Failure to inspect may result in patient harm or additional device damage.

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Reprocessing Manual for da Vinci Xi Accessories

INTRODUCTION

General Warnings, Cautions, and Notes (continued) CAUTION • Do not use chemical disinfection for devices, unless otherwise noted. Chemical disinfection may result in device damage. • Remove all accessories before cleaning. Failure to remove accessories prior to reprocessing may result in inadequate cleaning and sterilization, which may lead to patient harm. • In jurisdictions where the practice of chemical pre-disinfection is required, do not expose instruments, endoscopes, and accessories to chemical pre-disinfectants containing peroxidebased, strong alkaline or bleach-based chemicals. Doing so may result in device damage, which may lead to procedure delay. • Exposure of instruments, endoscopes, and accessories to chemical pre-disinfectants should be limited to the minimum contact time recommended by the pre-disinfectant manufacturer to achieve the level of pre-disinfection required by the hospital. Longer exposure times could result in device damage, which may lead to procedure delay.

Reprocessing Manual for da Vinci Xi Accessories

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INTRODUCTION

General Warnings, Cautions, and Notes (continued) NOTE • Reusable devices, including cautery cords, gage pins, and endoscope trays, are not supplied sterile and must be cleaned and sterilized before use. • Do not use equipment (for example, steam cleaning devices) or procedures that employ pre-cleaning temperatures greater than 60 °C (140 °F). High temperatures may fix residual soil to the surface, and make cleaning more difficult. • Always handle devices with care to avoid mechanical shock or stress, which may result in device damage. • Use only process chemicals that conform to legal and regulatory requirements for safety as required by the jurisdiction in question. • When disposing of Intuitive Surgical instruments, accessories, or components, follow institution biohazard protocol and all applicable national and local laws and guidelines. • Follow ISO 17665-1 and the specifications of the sterilization device manufacturer. • Refer to the sterilization system manufacturers' instructions for proper use of the system and recommendations for sterilization. • Any reference in the instruction stating that reprocessing must start within 60 minutes after the procedure is based on our validation. A hospital's internal process validation may support a longer reprocessing start time. • Do not use the Instrument/Stapler Release Kit (IRK/SRK) on the instrument except during emergency or intraoperative scenarios. If kit is used, do not use device. • Avoid prolonged exposure to either ultrasonic cleaning or cleaning agents.

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Reprocessing Manual for da Vinci Xi Accessories

INTRODUCTION

Text Glossary Accessories: Components that are used in conjunction with instruments. Automated Cleaning: Cleaning process in which a washer disinfector is used as part of the process. Clean Side: An area in hospitals and other healthcare facilities where medical devices that have already been cleaned in the "Dirty Side" are inspected, packaged, and sterilized. Clean Side is sometimes referred to as the "Prep and Pack." Cold Water: Unless otherwise specified, the term “cold water” refers to tap water that is 1025 °C (50-77 °F) and potable or better. CSSD: (Central Sterile Supply Department), also called sterile processing department (SPD), is a department in hospitals and other healthcare facilities that performs cleaning, sterilization and other actions on medical devices and equipment. Dirty Side: An area in hospitals and other healthcare facilities where medical devices are cleaned and disinfected. Dirty Side is sometimes referred to as the "Decon." Final Rinse Step: The final rinsing step of a cleaning process. High purity water: Examples of high purity water include deionized (DI) water, reverse osmosis (RO), and distilled water. High purity water is a type of water defined by ISO 15883-1. High purity water is extensively treated (usually by a multi-step treatment process that could include carbon bed, softening, DI, and RO or distillation) to ensure that microorganisms and the inorganic and organic material are removed from the water. Operating Room (OR): Also called Operating Theater, is a room where surgery is often performed. Soil: Also called "residual soil." Body fluids or tissue that may remain on the device after reprocessing. Sterile Processing Department (SPD): Also called Central Sterile Supply Department (CSSD) is a department in hospitals and other healthcare facilities that performs cleaning, sterilization and other actions on medical devices and equipment. Washer Disinfector: A machine intended to clean and disinfect medical devices and other articles used in the context of medical practice as defined in ISO 15883-1.

Reprocessing Manual for da Vinci Xi Accessories

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INTRODUCTION

Symbol Glossary CHEMICAL (BOTTLE)

CHEMICAL DISINFECTANT

SPRAY BOTTLE

SYRINGE (LUER SLIP TIP)

FLUSH PORT ICON

SOFT, LINT-FREE CLOTH

REFER TO MANUAL

NYLON BRUSH

TIME: SECONDS

CLEAN, DRY AIR

TIME: MINUTES

MAGNIFIER

STAINLESS STEEL STERILIZATION TRAY

SOAK BIN

PLASTIC STERILIZATION TRAY

FLUSH PORT ADAPTER

seconds

minutes

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Reprocessing Manual for da Vinci Xi Accessories

INTRODUCTION

Symbol Glossary (continued) STERILIZATION CONTAINER

PEEL PACK

WASHER DISINFECTOR MACHINE

STERILIZATION MACHINE

STERILIZATION WRAP

HIGH PURITY WATER

Reprocessing Manual for da Vinci Xi Accessories

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INTRODUCTION

Overview of Accessory Groups

For a complete list refer to Reprocessing Instructions Appendices PN 554154.

GROUP 1

Cannulae, Obturators, Release Kits, Hasson Cone, Instrument Introducers, Gage Pins, Single-Site Suction Irrigator Kit, and others.

Cannulae

Obturators

1

1

2

2

3

3

4

4

Release Kits Suction Irrigator Tube Adapter

Hasson Cone

Introducer

Suction Irrigator Tubing

Gage Pin

Single-Site Suction Irrigator Kit

GROUP 2 Cords

Monopolar Cautery Cord

GROUP 3

Trays

Plastic Sterilization Tray

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Bipolar Cautery Cord

Stainless Steel Sterilization Tray

Reprocessing Manual for da Vinci Xi Accessories

Xi GROUP 1

ACCESSORIES

GROUP 1

Cannulae, Obturators, Release Kits, Hasson Cone, Instrument Introducers, Gage Pins, Suction Irrigator Kit, and others (see Reprocessing Instructions Appendices PN 554154 for complete list)

Cleaning, Disinfection, and Sterilization Information for Reusable Accessories that are used with da Vinci Xi Systems

1

2

3

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Reprocessing Manual for da Vinci Xi Accessoriese

GROUP 1: INSTRUMENT ACCESSORIES

Accessories Group 1 Overview

Cannulae, Obturators, Release Kits, Hasson Cone, Instrument Introducers, Gage Pins, Single-Site Suction Irrigator Kit, and other. For a complete list refer to Reprocessing Instructions Appendices PN 554154. NOTE • Do not use the Instrument/Stapler Release Kit (IRK/SRK) on the instrument except during emergency or intraoperative scenarios. If kit is used, do not use device. • Single-Site Suction Irrigator Kit is to be reprocessed with the Single-Site Suction Irrigator instrument.

Cannulae

Obturators

1

1

2

2

3

3

4

4

Release Kits Suction Irrigator Tube Adapter

Hasson Cone

Introducer

Gage Pin

Reprocessing Manual for da Vinci Xi Accessories

Suction Irrigator Tubing

Single-Site Suction Irrigator Kit

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GROUP 1: INSTRUMENT ACCESSORIES

AUTOMATED CLEANING PROCESS

Automated Cleaning Process Overview

Reprocessing the accessories requires cleaning, disinfection, and sterilization. The 'Wet' step for the accessories should begin immediately after the procedure to prevent drying. If 'Wet' step in the operating room (OR) is not possible within 60 minutes, start the soak in dirty side within 60 minutes. See the diagram below for an overview of the reprocessing steps that take place in the OR, dirty side, and clean side.

OR (page 21) OR Preparation

Dirty Side, Automated Cleaning (page 27)

Step 1

Remove Accessories

Dirty Side Preparation

Step 2

Wipe

Step 1

Remove Accessories

Step 3

Wet

Step 2

Prepare Solution

Step 4

Chemical Pre-Disinfection (optional)¹

Prepare for Automated Cleaning

Step 5

Transport

Step 3

Soak

Step 4

Rinse

Step 5

Brush

Step 6

Final Rinse

Step 7

Inspect

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Sterilization Preparation Step 1

Dry

Step 2

Final Inspection

Pack and Sterilize

Conduct Automated Cleaning and Disinfection

1

Clean Side (page 45)

Step 8

Automated Cleaning

Step 9

Transfer

Step 3

Pack

Step 4

Wrap or Prepare

Step 5

Sterilize

Store Step 6

Store

The practice of Chemical Pre-Disinfection may be required in some jurisdictions.

Reprocessing Manual for da Vinci Xi Accessories

GROUP 1: INSTRUMENT ACCESSORIES

MANUAL CLEANING PROCESS

Manual Cleaning Process Overview

Reprocessing the accessories requires cleaning, disinfection (optional), and sterilization. The 'Wet' step for the accessories should begin immediately after the procedure to prevent drying. If 'Wet' step in the operating room (OR) is not possible within 60 minutes, start the soak in dirty side within 60 minutes. See the diagram below for an overview of the reprocessing steps that take place in the OR, dirty side, and clean side.

OR (page 21) OR Preparation

Dirty Side, Manual Cleaning (page 35)

Step 1

Remove Accessories

Dirty Side Preparation

Step 2

Wipe

Step 1

Remove Accessories

Step 3

Wet

Step 2

Prepare Solution

Step 4

Chemical Pre-Disinfection (optional)¹

Conduct Cleaning

Step 5

Transport

Step 3

Soak

Step 4

Rinse

Step 5

Brush

Step 6

Ultrasonic Cleaning (optional)

Step 7

Final Rinse

Step 8

Inspect

Step 9

Thermal Disinfection²

Step 10

Transfer

1

The practice of Chemical Pre-Disinfection may be required in some jurisdictions.

2

Thermal Disinfection may be optional in some jurisdictions.

Reprocessing Manual for da Vinci Xi Accessories

Clean Side (page 45) Sterilization Preparation Step 1

Dry

Step 2

Final Inspection

Pack and Sterilize Step 3

Pack

Step 4

Wrap or Prepare

Step 5

Sterilize

Store Step 6

Store

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Reprocessing Manual for da Vinci Xi Accessories