da Vinci Xi EndoWrist , Single-Site and Stapler Reprocessing Instructions

Copyright © 2018 Intuitive Surgical, Inc. All rights reserved. Trademarks Intuitive Surgical, da Vinci Xi, EndoWrist, and Single-Site are trademarks or registered trademarks of Intuitive Surgical, Inc. Product names are trademarks or registered trademarks of their respective holders.

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

Table of Contents INTRODUCTION

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

DA VINCI XI INSTRUMENTS

6 6 7 9 10

13

Instrument Overview 15 da Vinci Xi EndoWrist and Xi Single-Site Flush Ports 16 da Vinci Xi Single-Site Suction Irrigator Flush Ports 16 Automated Cleaning Process Overview 18 Manual Cleaning Process Overview 19 Operating Room (OR)... 21 Remove Accessories 23 Check Indicator 25 Wipe 25 Prime and Wet 26 Chemical Pre-Disinfection 30 Transport 31 Dirty Side, Automated Cleaning... 33 Remove Accessories 35 Check Indicator 36 Prepare Solution 37 Prime 38 Soak 41 Flush 42 Spray 46 Brush 47 Rinse 48 Inspect 48 Automated Cleaning 49 Transfer 50

Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

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Table of Contents (continued) Dirty Side, Manual Cleaning... 51 Remove Accessories 53 Check Indicator 54 Prepare Solution 55 Prime 56 Soak 59 Flush 60 Spray 64 Brush 65 Rinse 66 Ultrasonic Cleaning 67 Flush 71 Final Rinse 75 Inspect 75 Thermal Disinfection 76 Transfer 76 Clean Side... 77 Dry 79 Final Inspection 80 Lubricate 82 Sterilization Warnings, Cautions, and Notes 83 Pack 84 Sterilization Process Parameters 85 Wrap or Prepare 86 Sterilize 87 Store 87

DA VINCI XI ENDOWRIST STAPLERS

89

Stapler Overview Stapler Automated Process Overview Stapler Manual Process Overview

91 92 93

Operating Room (OR)... 95 Remove Accessories 97 Wipe 98 Prime and Wet 99 Chemical Pre-Disinfection 100 Transport 101

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

Table of Contents (continued) Dirty Side, Automated Cleaning... 103 Remove Accessories 105 Prepare Solution 107 Prime 108 Soak 108 Stapler Flush and Spray Areas 109 Flush 110 Spray 115 Brush 116 Rinse 117 Inspect 117 Automated Cleaning 118 Transfer 119 Dirty Side, Manual Cleaning... 121 Remove Accessories 123 Prepare Solution 125 Prime 126 Soak 126 Stapler Flush and Spray Areas 127 Flush 128 Spray 133 Brush 134 Rinse 135 Ultrasonic Cleaning 136 Flush 138 Final Rinse 143 Inspect 143 Thermal Disinfection 144 Transfer 144 Clean Side... 145 Dry 147 Final Inspection 148 Stapler Lubrication Areas 149 Lubricate 150 Sterilization Warnings, Cautions, and Notes 153 Pack 154 Sterilization Process Parameters 155 Wrap or Prepare 156 Sterilize 157 Store 157 Reprocessing Manual for da Vinci Xi 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 Surgical. These instructions apply to the da Vinci Xi EndoWrist®, Xi Single-Site®, and Xi 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 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.

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Reprocessing Manual for da Vinci Xi 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.

Reprocessing Manual for da Vinci Xi 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. • 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. • Immediate-use steam sterilization (IUSS) or flash sterilization is not validated. Hospitals should follow their policies regarding the use of IUSS or flash sterilization. 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 17665-1:2006/(R)2013 or BS EN ISO 17665-1:2006 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 EN ISO 803697:2017 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 our validation. A hospital's internal process validation may support a longer reprocessing start time.

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

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 "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 BS EN ISO 15883-1:2009+A1:2014. 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 BS EN ISO 158831:2009+A1:2014.

Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

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INTRODUCTION

Symbol 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)

PEEL PACK

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

INTRODUCTION

Symbol Glossary (continued)

STERILIZATION MACHINE

WASHER DISINFECTOR MACHINE

STERILIZATION WRAP

HIGH PURITY WATER

Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

Xi INSTRUMENTS

da Vinci Xi Instruments Cleaning, Disinfection, and Sterilization Information for the EndoWrist and Single-Site Instruments that are used with da Vinci Xi Systems

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

INSTRUMENTS

Instrument Overview

Back of Housing

Disc Face

Shaft

Release Button Indicator Window

Wrist/joint

Tip

Top of Housing

NOTE The primary flush flow for most instruments exits into the housing. Important differences are: • Monopolar Curved Scissors – exits from tip • Single-Site instruments (other than Permanent Cautery Hook, Suction Irrigator, or Wristed Needle Driver) - 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 Xi EndoWrist and Single-Site Instruments

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INSTRUMENTS

da Vinci Xi EndoWrist and Xi Single-Site Flush Ports

Xi EndoWrist and Xi Single-Site instruments have a primary and secondary flush port, located on the back of the housing.

1 2

primary flush port secondary flush port

da Vinci Xi Single-Site Suction Irrigator Flush Ports

The Xi Single-Site Suction Irrigator instrument has a primary flush port located on the top of the housing, and secondary flush ports located on the back of the housing. Note that the primary flush port extrudes from the housing in order to fit the Suction Irrigator Tubing (details to follow). Either of the secondary ports are acceptable for secondary flushing.

2 2

1

16

primary flush port

secondary flush port

(extruded to fit Suction Irrigator Tubing)

(use either port for secondary flushing)

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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 33)

Step 1

Remove Accessories

Dirty Side Preparation

Step 2

Check Indicator

Step 3

Wipe

Step 4

Prime and Wet

Step 5

Chemical Pre-Disinfection¹ (optional)

Step 6

Transport

Step 1

Remove Accessories

Step 2

Check Indicator

Step 3

Prepare Solution

Clean Side (page 77) Sterilization Preparation Step 1

Dry

Step 2

Final Inspection

Prepare for Automated Cleaning

Step 3

Lubricate

Step 4

Prime

Pack and Sterilize

Step 5

Soak

Step 6

Flush

Step 7

Spray

Step 8

Brush

Step 9

Rinse

Step 10 Inspect

Step 4

Pack

Step 5

Wrap or Prepare

Step 6

Sterilize

Store Step 7

Store

Conduct Automated Cleaning and Disinfection Step 11 Automated Cleaning Step 12 Transfer

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

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments

INSTRUMENTS

MANUAL CLEANING PROCESS

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 Step 1

Remove Accessories

Step 2

Check Indicator

Step 3

Wipe

Step 4

Prime and Wet

Step 5

Chemical Pre-Disinfection¹ (optional)

Step 6

Transport

Dirty Side, Manual Cleaning (page 51) Dirty Side Preparation Step 1

Remove Accessories

Step 2

Check Indicator

Step 3

Prepare Solution

Clean Side (page 77) Sterilization Preparation Step 1

Dry

Step 2

Final Inspection

Conduct Cleaning

Step 3

Lubricate

Step 4

Prime

Pack and Sterilize

Step 5

Soak

Step 6

Flush

Step 7

Spray

Step 8

Brush

Step 9

Rinse

Step 10 Ultrasonic Cleaning

Step 4

Pack

Step 5

Wrap or Prepare

Step 6

Sterilize

Store Step 7

Store

Step 11 Flush Step 12 Final Rinse Step 13 Inspect Step 14 Thermal Disinfection² Step 15 Transfer

1 The practice of Chemical Pre-Disinfection may be required in some jurisdictions. 2 Thermal Disinfection may be optional in some jurisdictions.

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Reprocessing Manual for da Vinci Xi EndoWrist and Single-Site Instruments