da Vinci S and Si Instruments Reprocessing Instructions

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

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Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

Table of Contents INTRODUCTION

6

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

6 7 10 11

DA VINCI S AND SI INSTRUMENTS

13

Instrument Overview S and Si EndoWrist Flush Ports Si Single-Site Non-wristed Flush Ports Si Single-Site Suction Irrigator Port S and Si EndoWrist Stabilizer Flush Ports Automated Cleaning Process Overview Manual Cleaning Process Overview

15 16 16 17 17 18 19

Operating Room (OR)...21 Remove Accessories 23 Wipe 26 Prime and Wet 27 Chemical Pre-Disinfection 33 Transport 34 Dirty Side, Automated Cleaning...35 Remove Accessories 37 Prepare Solution 39 Prime 40 Soak 44 Flush 44 Spray 50 Brush 51 Rinse 52 Inspect 52 Automated Cleaning 53 Transfer 54

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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Table of Contents (continued) Dirty Side, Manual Cleaning...55 Remove Accessories 57 Prepare Solution 59 Prime 60 Soak 64 Flush 64 Spray 70 Brush 71 Rinse 72 Ultrasonic Cleaning 73 Flush 79 Final Rinse 85 Inspect 85 Thermal Disinfection 86 Transfer 86 Clean Side...87 Dry 89 Final Inspection 90 Lubricate 92 Sterilization Warnings, Cautions, and Notes 93 Pack 94 Sterilization Process Parameters 95 Wrap or Prepare 96 Sterilize 97 Store 97

DA VINCI SI ENDOWRIST STAPLER

99

Stapler Overview Stapler Automated Process Overview Stapler Manual Process Overview

101 102 103

Operating Room (OR)... 105 Remove Accessories 107 Wipe 109 Prime and Wet 110 Chemical Pre-Disinfection 111 Transport 112 Dirty Side, Automated Cleaning... 113 Remove Accessories 115 Prepare Solution 117 4

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

Table of Contents (continued) Prime Soak Stapler Flush and Spray Areas Flush Spray Brush Rinse Inspect Automated Cleaning Transfer

118 118 119 120 125 126 127 127 128 129

Dirty Side, Manual Cleaning... 131 Remove Accessories 133 Prepare Solution 135 Prime 136 Soak 136 Stapler Flush and Spray Areas 137 Flush 138 Spray 143 Brush 144 Rinse 145 Ultrasonic Cleaning 146 Flush 148 Final Rinse 153 Inspect 153 Thermal Disinfection 154 Transfer 154 Clean Side... 155 Dry 157 Final Inspection 158 Stapler Lubrication Areas 159 Lubricate 160 Sterilization Warnings, Cautions, and Notes 163 Pack 164 Sterilization Process Parameters 165 Wrap or Prepare 166 Sterilize 167 Store 167

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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INTRODUCTION

Introduction

These Instructions for Use contain the cleaning, disinfection, and sterilization instructions and parameters recommended by Intuitive. These instructions apply to the da Vinci S and da Vinci Si EndoWrist, Si Single-Site, and Si Stapler Instruments only. These instructions contain essential information for reprocessing instruments. Read these instructions in their entirety before reprocessing the instruments. Instruments 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.

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.

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Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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. • Remove all accessories before cleaning. Failure to remove accessories prior to reprocessing may result in inadequate cleaning and sterilization. • Do not reuse or reprocess single-use devices after being removed from package, even if unused. Reprocessing may result in incomplete sterilization and/or device damage. • 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. • 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 reprocessing, always inspect devices for any defects or damage. Failure to inspect may result in patient harm and/or additional device damage. • Do not use the Instrument/Stapler Release Kit (IRK/SRK) on the instrument except during emergency or intraoperative scenarios. Use of release kit will result in device damage. If kit is used, do not use device. • Do not reprocess the Stapler Instrument using the automated cleaning process with the STERIS AMSCO 7052HP and 7053HP Washer Disinfectors. Doing so will result in damage to the Stapler Instrument, which may lead to patient harm.

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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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. • Handle devices with care to avoid mechanical shock or stress, which may result in device damage. • 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. PPE includes: gloves, gown, mask, goggles or face shield and shoe covers. • 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. • Immediate-use steam sterilization (IUSS) or flash sterilization is not validated. Hospitals should follow their policies regarding the use of IUSS or flash sterilization. • 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. • Do not reprocess Single-Site Instruments using the automated cleaning process with the STERIS AMSCO 7052HP and 7053HP Washer Disinfectors. Doing so may result in device damage, which may lead to patient harm.

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Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

INTRODUCTION

General Warnings, Cautions, and Notes (continued) NOTE • Reusable devices 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 > 60 °C (140 °F). High temperatures may fix residual soil to the surface, and make cleaning more difficult. • 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 AAMI/ISO 17665-1 or BS EN ISO 17665-1 and the specifications of the sterilization device manufacturer. • Refer to the sterilization system manufacturer’s instructions for proper use of the system and recommendations for sterilization. • Use the Intuitive Surgical-provided Luer fitting or equivalent as defined by ISO 80369 attached to a pressurized cold water line. • 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 Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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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 "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." 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. Immediate-Use Steam Sterilization (IUSS): Process designed for the cleaning, steam sterilization, and delivery of patient care items for immediate use. Previously known as flash sterilization. Internal Flush Tube: The long plastic tube that permanently connects to the primary flush port and carries fluid to the end of the instrument shaft during flushing. 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 Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

ICON GLOSSARY

Icon Glossary CHEMICAL (BOTTLE)

SYRINGE (LUER SLIP TIP)

SPRAY BOTTLE

SOFT, LINT-FREE CLOTH

FLUSH PORT ICON

CHEMICAL DISINFECTANT

REFER TO MANUAL

NYLON BRUSH

TIME: SECONDS

CLEAN, DRY AIR

TIME: MINUTES

MAGNIFIER

SOAK BIN

FLUSH PORT ADAPTER

STERILIZATION TRAY

STERILIZATION CONTAINER

seconds

minutes

(optional)

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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ICON GLOSSARY

Icon Glossary (continued)

PEEL PACK

STERILIZATION MACHINE

WASHER DISINFECTOR MACHINE

STERILIZATION WRAP

HIGH PURITY WATER

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Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

S and Si INSTRUMENTS

da Vinci S and Si Instruments Cleaning, Disinfection, and Sterilization Information for Reusable Instruments that are used with da Vinci S and da Vinci Si Systems

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

INSTRUMENTS

Instrument Overview Top of Housing Wrist/joint

Shaft

Release Lever Back of Housing

Tip

Disc Face

NOTE The primary flush flow for most instruments exits into the housing. Important differences are: − Monopolar Curved Scissors – exits from tip − 5 mm Instruments - exits from shaft near housing − Single-Site Suction Irrigator - exits from tip

EndoWrist

Single-Site Wristed

Single-Site Non-Wristed

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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INSTRUMENTS

S and Si EndoWrist Flush Ports

Si EndoWrist and Single-Site (Permanent Cautery Hook and Wristed Needle Driver) instruments have a primary and secondary flush port located on the back of the housing.

2 1

primary flush port

secondary flush port

Si Single-Site Non-wristed Flush Ports

The Si Single-Site non-wristed instruments have a primary flush port located on the shaft next to the housing, and secondary flush port located on the back of the housing.

2

1

primary flush port

secondary flush port

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Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

INSTRUMENTS

Si Single-Site Suction Irrigator Port

The Si Single-Site Suction Irrigator instrument has a primary flush port located on the back of the housing.

1

SUC/IRR

primary flush port

S and Si EndoWrist Stabilizer Flush Ports

Si EndoWrist Stabilizer instrument has a primary and secondary flush port, located on the back of the housing, and four additional ports on the shaft cone.

3 4 5

2 1

6 flush port 4

flush port 3

flush port 5 flush port 6

primary flush port (1)

secondary flush port (2)

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

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AUTOMATED CLEANING PROCESS

INSTRUMENTS

Automated Cleaning Process Overview

Reprocessing the instrument requires cleaning, disinfection, and sterilization. The "Prime and Wet" step for the instrument 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 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.

OR (page 21) OR Preparation

Dirty Side, Automated Cleaning (page 35)

Step 1

Remove Accessories

Dirty Side Preparation

Step 2

Wipe

Step 1

Remove Accessories

Step 3

Prime and Wet

Step 2

Prepare Solution

Step 4

Chemical Pre-Disinfection (optional)¹

Step 5

Transport

Prepare for Automated Cleaning Step 3

Prime

Step 4

Soak

Step 5

Flush

Step 6

Spray

Step 7

Brush

Step 8

Rinse

Step 9

Inspect

Conduct Automated Cleaning and Disinfection

Clean Side (page 87) Sterilization Preparation Step 1

Dry

Step 2

Final Inspection

Step 3

Lubricate

Pack and Sterilize Step 4

Pack

Step 5

Wrap or Prepare

Step 6

Sterilize

Store Step 7

Store

Step 10 Automated Cleaning Step 11 Transfer

1

18

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

Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments

MANUAL CLEANING PROCESS

INSTRUMENTS

Manual Cleaning Process Overview

Reprocessing the instrument requires cleaning, disinfection, and sterilization. The "Prime and Wet" step for the instrument 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 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.

OR (page 21) OR Preparation

Dirty Side, Manual Cleaning (page 55)

Step 1

Remove Accessories

Dirty Side Preparation

Step 2

Wipe

Step 1

Remove Accessories

Step 3

Prime and Wet

Step 2

Prepare Solution

Step 4

Chemical Pre-Disinfection (optional)¹

Step 5

Transport

Conduct Cleaning Step 3

Prime

Step 4

Soak

Step 5

Flush

Step 6

Spray

Step 7

Brush

Step 8

Rinse

Step 9

Ultrasonic Cleaning

Step 10 Flush

Clean Side (page 87) Sterilization Preparation Step 1

Dry

Step 2

Final Inspection

Step 3

Lubricate

Pack and Sterilize Step 4

Pack

Step 5

Wrap or Prepare

Step 6

Sterilize

Store Step 7

Store

Step 11 Final Rinse Step 12 Inspect Step 13 Thermal Disinfection² Step 14 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 S and Si EndoWrist and Single-Site Instruments

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Reprocessing Manual for da Vinci S and Si EndoWrist and Single-Site Instruments