da Vinci Handheld Camera Reprocessing Instructions

Copyright © 2021 Intuitive Surgical, Inc. All rights reserved. Trademarks Intuitive Surgical, Intuitive, da Vinci Xi, and da Vinci X are registered trademarks of Intuitive Surgical, Inc. Product names are trademarks or registered trademarks of their respective holders.

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Reprocessing Manual for the da Vinci Handheld Camera

Table of Contents INTRODUCTION Indications for Use Symbols: Warnings, Cautions, and Notes General Warnings, Cautions, and Notes Glossary Symbol Glossary Handheld Camera and Accessories Overview

HANDHELD CAMERA Handheld Camera Overview Automated Cleaning Process Overview Manual Cleaning Process Overview

7 7 7 8 11 12 13

15 17 18 19

Operating Room (OR)...21 Remove Accessories 23 Wipe 24 Wet 25 Chemical Pre-Disinfection 26 Pack Tray 27 Transport 28 Dirty Side, Automated Cleaning Process...29 Remove Accessories 31 Wipe 32 Inspect 32 Pack Tray 33 Automated Cleaning 34 Transfer 35 Dirty Side, Manual Cleaning...37 Remove Accessories 39 Inspect 40 Prepare Solution 41 Soak 42 Rinse 42 Spray 43 Brush 44

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Table of Contents Final Rinse Final Dirty Side Inspect Chemical Disinfection Transfer

45 45 46 48

Clean Side...49 Dry 51 Final Inspection 52 Sterilization Warnings, Cautions, and Notes 53 Pack Tray 57 Validated Sterilization Process Parameters 58 Wrap 59 Sterilize 60 Store 60

GROUP 2 Group 2: Accessories Overview Automated Cleaning Process Overview Manual Cleaning Process Overview

61 63 64 65

Operating Room (OR)...67 Remove Accessories 69 Chemical Pre-disinfection 70 Transport 71 Dirty Side, Automated Cleaning Process...73 Remove Accessories 75 Wipe 78 Inspect 78 Automated Cleaning 79 Transfer 80 Dirty Side, Manual Cleaning...81 Remove Accessories 83 Wipe 86 Brush 86 Final Rinse 87

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Reprocessing Manual for the da Vinci Handheld Camera

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Table of Contents Final Dirty Side Inspect Thermal Disinfection Transfer

88 88 89

Clean Side...91 Dry 93 Final Inspection 94 Sterilization Warnings, Cautions, and Notes 95 Pack 96 97 Validated Sterilization Process Parameters Wrap or Prepare 98 Sterilize 99 Store 99

GROUP 3 Group 3: Tray Overview Automated Cleaning Process Overview Manual Cleaning Process Overview

101 103 104 105

Operating Room (OR)... 107 Wipe 109 Transport 111 Dirty Side, Automated Cleaning Process... 113 Wipe 115 Inspect 115 Pack 116 Dirty Side, Manual Cleaning Process... 117 Prepare Solution 119 Wipe 120 Brush 120 Final Rinse 121 Final Dirty Side Inspect 121 Thermal Disinfection 122 Transfer 122

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Table of Contents Clean Side... 123 Dry 125 Final Inspection 126 Sterilization Warnings, Cautions, and Notes 127 Sterilize 127

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Reprocessing Manual for the da Vinci Handheld Camera

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 Handheld Camera (referred to as camera in these instruction) and its accessories, and contain essential information for reprocessing the camera and its accessories. Read these instructions in their entirety before reprocessing the camera and its accessories. 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.

Indications for Use

The Handheld Camera Sterilization Tray is intended to encase and protect the IS4000 and IS4200 da Vinci Handheld Camera for automated cleaning and thermal disinfection in a washer disinfector, sterilization, and transport between the operating room and the central sterile supply department.

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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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. • 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. • Prior to use, after use, or during reprocessing, always inspect da Vinci Handheld Camera for any defects or damage to the camera lens, cable, and fiber optic surfaces. Failure to inspect may result in patient harm and/or additional camera damage. • 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. • Before cleaning and sterilizing the camera, disassemble and separate the light guide and adapter from camera. Failure to separate the light guide may result in incomplete reprocessing, 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. • Remove protective covers from light guide and adapter before reprocessing. Failure to remove protective covers prior to reprocessing may result in inadequate cleaning and sterilization, which may lead to patient harm.

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Reprocessing Manual for the da Vinci Handheld Camera

INTRODUCTION

General Warnings, Cautions, and Notes (continued) CAUTION • 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. • Do not autoclave da Vinci Handheld Camera. High temperatures and sudden temperature changes will result in camera damage, which may lead to procedure delay. • In jurisdictions where the practice of chemical pre-disinfection is required, do not expose cameras 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 cameras 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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INTRODUCTION

General Warnings, Cautions, and Notes (continued) NOTE • The da Vinci Handheld Camera is not supplied sterile and must be cleaned and sterilized before use. • Handle the da Vinci Handheld Camera with care to avoid mechanical shock or stress, which may result in damage to the da Vinci Handheld Camera. • 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 local jurisdiction. • When disposing of Intuitive Surgical devices, follow institution biohazard protocol and all applicable national and local laws and guidelines. • Observe ISO 17665-1 and the specifications of the sterilization device manufacturer. • 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.

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Reprocessing Manual for the da Vinci Handheld Camera

INTRODUCTION

Glossary Accessories: Components that are used in conjunction with the camera. Automated Cleaning: Cleaning process in which a washer disinfector is used as part of the process. Camera: The camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems. Central Sterile Supply Department (CSSD): 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. Clean Side: An area in hospitals and other healthcare facilities where medical devices that have already been cleaned in "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. 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. 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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INTRODUCTION

Symbol Glossary CHEMICAL (BOTTLE)

LINT-FREE CLOTH

SPRAY BOTTLE

NYLON BRUSH

HIGH PURITY WATER

CLEAN, DRY AIR

REFER TO MANUAL

MAGNIFIER

TIME: SECONDS

HANDHELD CAMERA STERILIZATION TRAY

TIME: MINUTES

SOAK BIN

minutes

STERILIZATION CONTAINER

STERILIZATION MACHINE

WASHER DISINFECTOR MACHINE or THERMAL DISINFECTION MACHINE

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PEEL PACK

STERILIZATION WRAP

Reprocessing Manual for the da Vinci Handheld Camera

INTRODUCTION

Handheld Camera and Accessories Overview da Vinci Handheld Camera (referred to as camera in these instructions)

GROUP 2

Handheld Camera Light Guide and Handheld Camera Light Guide Adapter (referred to as light guide and adapter in these instructions)

Light Guide

GROUP 3

Adapter

Handheld Camera Sterilization Tray (PN 400499) (referred to as tray in these instructions)

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Reprocessing Manual for the da Vinci Handheld Camera

da Vinci Handheld Camera

Cleaning, disinfection, and sterilization information for the reusable da Vinci Handheld Camera used with da Vinci Xi and da Vinci X Systems

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HANDHELD CAMERA

HANDHELD CAMERA

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Reprocessing Manual for the da Vinci Handheld Camera

HANDHELD CAMERA

Handheld Camera Overview

The camera is one assembly that consists of a camera head, cable, focus and zoom rings, and a camera lens as shown in the figure below. The camera is used with the light guide and adapter accessories, but the camera is reprocessed separately from these accessories.

Camera Lens

Camera Head

Focus and Zoom Rings

Release Button Cable

Camera Connector

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HANDHELD CAMERA

AUTOMATED CLEANING PROCESS

Automated Cleaning Process Overview

Reprocess the camera only, without the accessories, using the automated cleaning process. Reprocessing the camera requires cleaning, disinfection, and sterilization. The 'Wet' step for the camera should begin immediately after the procedure to prevent drying. If '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.

Operating Room (OR) (pg. 21)

OR Preparation

Dirty Side, Automated Cleaning (pg. 29)

Step 1

Remove Accessories

Dirty Side Preparation

Clean Side (pg. 49)

Step 2

Wipe

Step 1

Remove Accessories

Sterilization Preparation

Step 3

Wet

Step 2

Wipe

Step 4

Chemical Pre-disinfection (optional)1

Step 3

Inspect

Step 5

Pack

Step 4

Pack

Step 6

Transport

Conduct Automated Cleaning and Thermal Disinfection

Step 1

Dry

Step 2

Final Inspection

Pack and Sterilize

Step 5

Automated Cleaning

Step 6

Transfer

Step 3

Pack

Step 4

Wrap

Step 5

Sterilize

Store Step 6

Store

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

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Reprocessing Manual for the da Vinci Handheld Camera

HANDHELD CAMERA

MANUAL CLEANING PROCESS

Manual Cleaning Process Overview

The camera can be reprocessed using the manual cleaning process. Reprocessing the camera requires cleaning, disinfection (optional), and sterilization. The 'Wet' step for the camera should begin immediately after the procedure to prevent drying. If 'Wet' in the operating room (OR) is not possible within 60 minutes, start the 'Soak' step 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.

Operating Room (OR) (pg. 21)

OR Preparation Step 1

Remove accessories

Step 2

Wipe

Step 3

Wet

Step 4

Chemical Pre-disinfection (optional)¹

Step 5

Pack

Step 6

Transport

Dirty Side, Manual Cleaning (pg. 37)

Dirty Side Preparation Step 1

Remove Accessories

Step 2

Inspect

Step 3

Prepare Solution

Conduct Manual Cleaning Step 4

Soak

Step 5

Rinse

Step 6

Spray

Step 7

Brush

Step 8

Final Rinse

Step 9

Final Dirty Side Inspect

Step 10

Chemical Disinfection 2

Step 11

Transfer

Clean Side (pg. 49) 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

1 The practice of chemical pre-disinfection may be required in some jurisdictions. 2 Chemical disinfection may be optional in some jurisdictions.

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Reprocessing Manual for the da Vinci Handheld Camera