ENDOSCOPE 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.

Indication for Use: Plastic Endoscope Sterilization Tray (PN 400490) The 8 mm Endoscope Sterilization Tray is intended to encase and protect da Vinci Xi endoscopes for sterilization and transport between the operating room and the central sterile supply department.

Indication for Use: Stainless Steel Endoscope Sterilization Tray (PN 400498) The 8 mm Endoscope Sterilization Tray is intended to encase and protect da Vinci Xi endoscopes for automated cleaning and thermal disinfection in a washer disinfector, sterilization, and transport between the operating room and the central sterile supply department.

Indication for Use: Endoscope Washer Disinfector Connector Set (PN 400482) The Endoscope Washer Disinfector Connector Set is intended to be used with the endoscope sterilization tray and Xi endoscopes during automated cleaning and thermal disinfection in a washer disinfector. The Endoscope Washer Disinfector Connector Set connects the flush ports of the endoscope to the washer disinfector during automated cleaning and thermal disinfection.

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Reprocessing Instructions for the da Vinci Xi Endoscope

Table of Contents INTRODUCTION

5

Symbols: Warnings, Cautions, and Notes General Warnings, Cautions, and Notes Text Glossary Symbol Glossary

DA VINCI XI ENDOSCOPE Endoscope Identification Xi Endoscope Plus Overview Endoscope (without Connector Cover) Overview Endoscope (with Connector Cover) Overview Endoscope Flush Ports and Flush Areas Automated Cleaning Process Overview Manual Cleaning Process Overview

5 6 8 9

11 13 14 15 16 17 18 19

Operating Room (OR)...21 Clean Cover 23 Wipe 24 Prime and Wet 25 Chemical Pre-Disinfection 27 Pack Plastic Tray 28 Pack Stainless Steel Tray 29 Transport 30 Dirty Side, Automated Cleaning...31 Wipe 33 Inspect 34 Inspect Connector Set 35 Load Stainless Steel Tray 36 Attach Connector Set 37 Automated Cleaning 38 Remove Connector Set 40 Transfer 41

Reprocessing Instructions for the da Vinci Xi Endoscope

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Table of Contents (continued) Dirty Side, Manual Cleaning...43 Inspect 45 Clean Cover 46 Prepare Solution 48 Prime 49 Soak 50 Rinse 50 Flush 51 Spray 52 Brush 53 Final Rinse 54 Dry 54 Final Dirty Side Inspect 55 Chemical Disinfection 56 Transfer 57 Clean Side...59 Dry 61 Final Inspection 62 Sterilization Warnings, Cautions, and Notes 63 Pack Plastic Tray 67 Pack Stainless Steel Tray 68 Validated Sterilization Process Parameters 70 Wrap Tray 73 Sterilize 74 Store 74

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Reprocessing Instructions for the da Vinci Xi Endoscope

Introduction

INTRODUCTION

These Instructions for Use contain the cleaning, disinfection, and sterilization instructions and parameters recommended by Intuitive Surgical. These instructions apply to the da Vinci Xi® endoscopes. These instructions contain essential information for reprocessing the endoscope. Read these instructions in their entirety before reprocessing the endoscope. The endoscope is 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 Symbol Glossary 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 Instructions for the da Vinci Xi Endoscope

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INTRODUCTION

General Warnings, Cautions, and Notes WARNING • Devices are to be handled, reprocessed, and operated by trained personnel only. Inadequate training may result in device damage or patient/operator harm. • 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. • Remove tip protector from endoscope before reprocessing. Failure to remove tip protector prior to reprocessing may result in inadequate cleaning and sterilization, which may lead to patient harm. • Use care in handling chemicals and contaminated solutions, as skin contact, inhalation, or ingestion may cause injury. • 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. • Prior to use, after use, or during reprocessing, always inspect endoscope for any defects or damage to the tip or lens, light ports, fiber optic surfaces, and cable. Failure to inspect may result in patient harm or additional endoscope damage. • 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. CAUTION • In jurisdictions where the practice of chemical pre-disinfection is required, do not expose instruments, endoscopes, and accessories to chemical pre-disinfectants containing peroxide-based, 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.

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Reprocessing Instructions for the da Vinci Xi Endoscope

INTRODUCTION

General Warnings, Cautions, and Notes (continued) NOTE • Endoscopes are not supplied sterile and must be cleaned and sterilized before use. • Always handle devices with care to avoid mechanical shock or stress, which may result in device (endoscope) damage. • Exercise care when handling the tip (lens) of the endoscope: − Do not apply excessive force on the tip − Do not clean with sharp objects or instruments • Do not autoclave da Vinci Xi endoscopes. High temperatures and sudden temperature changes will result in endoscope damage. • Do not use equipment (for example, steam cleaning devices) or procedures that employ pre-cleaning temperatures > 60 °C (140 °F). High temperatures may fix residual soil to the surface, and make cleaning more difficult. • When reprocessing Intuitive Surgical endoscopes that are supplied without a connector cover, temperatures should not exceed 95 °C (203 °F). • When reprocessing Intuitive Surgical endoscopes supplied with a connector cover, temperatures should not exceed 60 °C (140 °F). • Intuitive Surgical endoscopes that are supplied with a connector cover are not compatible with automated washer disinfector systems and should be cleaned using only the manual cleaning process. • Use only process chemicals that conform to legal and regulatory requirements for safety as required by local jurisdiction. • When disposing of Intuitive Surgical devices, follow institution biohazard protocol and all applicable national and local laws and guidelines. • Use the Intuitive Surgical-provided Luer fitting or equivalent as defined by ISO 80369-7 attached to a pressurized cold water line. • In some jurisdictions, the practice of chemical pre-disinfection is required prior to the start of reprocessing in the SPD or CSSD. • Any reference in the instruction stating that reprocessing must start within 60 minutes after the procedure is based on Intuitive Surgical's validation. A hospital's internal process validation may support a longer reprocessing start time.

Reprocessing Instructions for the da Vinci Xi Endoscope

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INTRODUCTION

Text Glossary Accessories: Components that are used in conjunction with instruments and endoscopes. 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 10-25 °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." Endoscope: An imaging system specifically designed for the da Vinci Surgical System that is used to view the inside of the patient’s body. 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.

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Reprocessing Instructions for the da Vinci Xi Endoscope

INTRODUCTION

Symbol Glossary CHEMICAL (BOTTLE)

SYRINGE (LUER SLIP TIP)

SPRAY BOTTLE

SOFT, LINT-FREE CLOTH

FLUSH PORT ICON

NYLON BRUSH

REFER TO MANUAL

CLEAN, DRY AIR

TIME: SECONDS

MAGNIFIER

TIME: MINUTES

SOAK BIN

PLASTIC STERILIZATION TRAY

FLUSH PORT ADAPTER

STAINLESS STEEL STERILIZATION TRAY

STERILIZATION MACHINE

seconds

minutes

CHEMICAL DISINFECTANT

Reprocessing Instructions for the da Vinci Xi Endoscope

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INTRODUCTION

Symbol Glossary (continued)

WASHER DISINFECTOR MACHINE

STERILIZATION WRAP

HIGH PURITY WATER

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Reprocessing Instructions for the da Vinci Xi Endoscope

Xi ENDOSCOPE

da Vinci Xi ENDOSCOPE Cleaning, Disinfection, and Sterilization Information for Reusable Endoscopes that is used with da Vinci Xi Systems

Reprocessing Instructions for the da Vinci Xi Endoscope

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ENDOSCOPE

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Reprocessing Instructions for the da Vinci Xi Endoscope

ENDOSCOPE

Marking on Side

Endoscope Identification

Housing

Xi Endoscope Plus

Flush Port Release Tab (white)

Five Gears on Bottom of Base

Endoscope Connector with Degree Marking

Housing

Endoscope without Connector Cover

Flush Port Release Tab (gray)

Three Gears on Bottom of Base

Endoscope Connector

Endoscope with Connector Cover

Housing

Flush Port Release Tab (gray)

Three Gears on Bottom of Base Endoscope Connector

Reprocessing Instructions for the da Vinci Xi Endoscope

Connector Cover and Lanyard

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ENDOSCOPE

Xi Endoscope Plus Overview

The endoscope consists of the tip, shaft, base, housing, cable, as shown in the figure below.

Fiber Optic Surfaces (x2) (Light Ports)

Lens

Shaft

Tip

Indicator Windows

Bottom of Base

Base

Housing

Flush Port Release Tab

Cable

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Endoscope Connector

Reprocessing Instructions for the da Vinci Xi Endoscope

ENDOSCOPE

Endoscope (without Connector Cover) Overview

The endoscope consists of the tip, shaft, base, housing, and cable, as shown in figure below.

Fiber Optic Surfaces (x2) (Light Ports)

Lens

Tip

Shaft

Indicator Windows

Bottom of Base

Base

Housing

Flush Port Release Tab

Cable

Reprocessing Instructions for the da Vinci Xi Endoscope

Endoscope Connector

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ENDOSCOPE

Endoscope (with Connector Cover) Overview

The endoscope consists of the tip, shaft, base, housing, cable, and a connector cover with lanyard as shown in figure below.

Fiber Optic Surfaces (x2) (Light Ports)

Lens

Tip

Shaft

Indicator Windows

Bottom of Base

Base

Housing

Flush Port Release Tab

Connector Cover and Lanyard

Cable

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Endoscope Connector

Reprocessing Instructions for the da Vinci Xi Endoscope

ENDOSCOPE

Endoscope Flush Ports and Flush Areas The endoscope contains three flush ports and three flush areas.

Flush Port Release Tab Button Flush Ports 1

2

3

1

2

Base Flush Areas

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Reprocessing Instructions for the da Vinci Xi Endoscope

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AUTOMATED CLEANING PROCESS

ENDOSCOPE INTRODUCTION

Automated Cleaning Process Overview

Only the endoscope without the connector cover can be reprocessed using the automated cleaning process. Reprocessing the endoscope requires cleaning, disinfection, and sterilization. The 'Prime and Wet' step for the endoscope should begin immediately after the procedure to prevent drying. If 'Prime and Wet' in the operating room (OR) is not possible within 60 minutes, start the Automated Cleaning and Disinfection in the 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.

Only

WITHOUT CONNECTOR COVER example connector

OR (page 21) OR Preparation Step 1

Clean Connector Cover¹

Step 2

Wipe

Step 3

Prime and Wet

Step 4

Chemical Pre-Disinfection (optional)²

Step 5

Pack

Step 6

Transport

Dirty Side, Automated Cleaning (page 31) Dirty Side Preparation

Clean Side (page 59)

Step 1 Wipe

Sterilization Preparation

Step 2 Inspect Step 3 Inspect Connector Set Step 4 Load Tray

Conduct Automated Cleaning and Thermal Disinfection Step 5 Attach Connector Set Step 6 Automated Cleaning Step 7 Remove Connector Set Step 8 Transfer

Step 1

Dry

Step 2

Final Inspection

Pack and Sterilize Step 3

Pack

Step 4

Wrap

Step 5

Sterilize

Store Step 6

Store

1 Endoscopes with connector covers are not compatible with automated cleaning. Therefore, no connector cleaning is required if using the automated cleaning process. 2

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The practice of chemical pre-disinfection may be required in some jurisdictions.

Reprocessing Instructions for the da Vinci Xi Xi Endoscope Endoscope

INTRODUCTION MANUAL CLEANING PROCESS

ENDOSCOPE

Manual Cleaning Process Overview

Both endoscopes (with and without connector cover) can be reprocessed using the manual cleaning process. Reprocessing the endoscope requires cleaning, disinfection (optional), and sterilization. The 'Prime and Wet' step for the endoscope should begin immediately after the procedure to prevent drying. If 'Prime and Wet' in the operating room (OR) is not possible within 60 minutes, start the prime and 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. WITH CONNECTOR COVER example connector

WITHOUT CONNECTOR COVER example connector

or

OR (page 21) OR Preparation

Dirty Side, Manual Cleaning (page 43)

Step 1

Clean Connector Cover¹

Dirty Side Preparation

Step 2

Wipe

Step 1

Inspect

Step 3

Prime and Wet

Step 2

Clean Connector Cover¹

Step 4

Chemical pre-disinfection (optional)²

Step 3

Prepare Solution

Step 5

Pack

Step 6

Transport

Conduct Manual Cleaning Step 4

Prime

Step 5

Soak

Step 6

Rinse

Step 7

Flush

Step 8

Spray

Step 9

Brush

Step 10

Final Rinse

Step 11

Dry

Step 12

Final Dirty Side Inspect

Step 13

Chemical Disinfection (optional)

Step 14

Transfer

1

If connector cover provided.

2

The practice of chemical pre-disinfection may be required in some jurisdictions.

Reprocessing Instructions for the da Vinci Xi Endoscope

Clean Side (page 59) Sterilization Preparation Step 1

Dry

Step 2

Final Inspection

Pack and Sterilize Step 3

Pack

Step 4

Wrap

Step 5

Sterilize

Store Step 6

Store

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INTRODUCTION

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Reprocessing Instructions for the da Vinci Xi Endoscope