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Johnson & Johnson Surgical Vision Veritas User Manual

Johnson & Johnson Surgical Vision Veritas
270 pages
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Z370584 Rev. D, 09/2020 © Johnson & Johnson Surgical Vision, Inc. 2020
Software Release: 8.000
OPERATOR MANUAL

Table of Contents

Questions and Answers:

Johnson & Johnson Surgical Vision Veritas Specifications

General IconGeneral
BrandJohnson & Johnson Surgical Vision
ModelVeritas
CategoryMachine Vision Systems
LanguageEnglish

Summary

1 - Introduction

Introduction

Overview of the VERITAS Vision System, a premium cataract system for anterior segment surgery.

Document Conventions

Explains the use of precautionary statements (cautions and warnings) in the manual.

Intended Use / Indications

Details the system's purpose in anterior segment (cataract) surgery and its modular design.

Contraindications

Lists any pre-existing patient conditions that contraindicate cataract surgery.

Undesirable Side Effects

Complications that may be associated with the VERITAS Vision System use.

Intended Patient

Specifies adult patients with cataracts or undergoing anterior segment ophthalmic surgery.

Intended User

Identifies the system as intended for use by an ophthalmologist and support staff.

Clinical Benefits

Outlines the advantages of the VERITAS Vision System for patients.

Performance Characteristics

Details system capabilities like phacoemulsification, diathermy, vitrectomy, and advanced technologies.

Device Description

Provides an overview of the VERITAS Vision System console, display, and primary functions.

2 — Warnings, Cautions, and Other Residual Risks

Cautions

Safety precautions for system setup and operation, including electrical safety and handling.

Warnings

Critical safety information for personnel operating the equipment, including modifications and electrical safety.

Residual Risks

Summarizes the final residual risk level rating for VERITAS Vision System items.

Regulatory Symbol Definitions

Defines symbols with regulatory relevance found on the system's front and back panels.

Regulatory Compliance Statements

Details FCC and Industry Canada compliance statements for the device.

System Disposal

Provides guidance on the proper disposal of electronic equipment (WEEE directive).

Toxic and Hazardous Substances

Information on RoHS compliance in the EU and China, and EU REACh.

Packaging Information

Details the packaging weight and materials for the VERITAS Vision System.

Serious Incident Reporting

Instructions on how to report serious incidents to JJSV and the competent authority.

Instructions for Minimizing the Environmental Impact During Normal Use

Methods to reduce environmental impact during system use, like using reusable accessories.

3 — System Components

Receipt and Inspection Instructions

Guidance on inspecting exterior packaging for shipping damage and filing claims.

VERITAS Vision System Components

Lists the main components of the VERITAS Vision System.

Tubing Packs

Describes the disposable tubing packs required for surgical procedures.

Foot Pedal

Explains the function and operation of the foot pedal for system control.

VERITAS Heel Insert (Optional)

Details the optional heel insert accessory for the VERITAS Foot Pedal.

Programmable IV Pole

Describes the function and control of the programmable IV pole.

VERITAS Remote Control

Explains the use of the wireless remote control for system navigation and adjustments.

Surgical Media Center (SMC) (Optional)

Details the optional SMC for recording surgery and instrument settings.

4 — Surgery Start Up

VERITAS Vision System Setup

Provides an overview of steps to prepare the VERITAS Vision System for surgery.

Front and Rear Panel Connections

Illustrates and describes the front and rear panel connections for handpieces.

IV Pole Setup

Step-by-step guide for setting up the IV pole for surgical procedures.

Handpiece Setup

Instructions for setting up phacoemulsification, I/A, diathermy, and vitrectomy handpieces.

Startup

Describes the system self-test process and the initial surgeon/program selection screen.

Install the Tubing Pack

Guidance on selecting a program and installing the tubing pack.

Cup Fill

Procedure for collecting balanced salt solution using the test chamber or a cup.

Prime/Tune

Explains the necessity and process of priming and tuning handpieces before use.

Verify Irrigation/Aspiration Balance

Procedure to verify the proper balance of irrigation and aspiration settings.

Priming for Vitrectomy

Steps to prime the vitrectomy handpiece to reduce the chance of errors.

Selecting and Changing Mode Parameters

How to navigate the GUI and adjust operating levels for aspiration, vacuum, and power.

System Check-out

Procedure to verify system installation and proper operation before the first case.

Pre-operative Sterilization

Recommendations for sterilizing system instruments prior to each surgical case.

End Case

Functionality to review and terminate the current surgical case.

System Shutdown

Steps for properly shutting down the VERITAS Vision System after surgery.

5 — Surgeon Settings

Select Surgeon

Instructions for selecting or managing surgeon profiles on the system.

Add a New Surgeon

Procedure to create a new surgeon profile and enter their name.

Delete Surgeon

Steps to remove a surgeon's profile from the system's list.

Edit a Surgeon

How to edit an existing surgeon's name or settings.

Edit Surgeon Settings

Defines venting, tap for irrigation, and Cont. Irr. Auto-Off preferences.

Foot Pedal Setup

Guides users through setting up, calibrating, and testing foot pedals.

Set Sound Levels

Instructions for adjusting system sound levels and tone preferences.

Surgeon – Assign Order

How to change the order of surgeon names displayed on the system.

6 — Program Settings

Create a New Program

Procedure for creating custom surgical programs with preferred settings.

Delete a Program

Steps to remove a surgeon program from the Select Program screen.

Edit a Program Name

How to rename existing surgical programs.

Lock a Program

Procedure to lock a program's settings, preventing changes once done.

Copy a Surgeon Program

How to copy settings from one surgeon program to another.

Assign Program Order

Method to reorder programs, setting a default or preferred program.

Program Settings

Defines specific settings for major surgical modes like Phaco, I/A, Vitrectomy, Diathermy.

Default Settings

Provides default parameter settings for various gauge programs and modes.

Phaco Power Settings

Details the various phaco power delivery modes available.

WHITESTAR Technology

Explains the advanced WHITESTAR technology for phacoemulsification.

FUSION Fluidics Phaco

Describes the FUSION Fluidics system for intelligent vacuum monitoring.

7 — System Configuration

Setting the Maximum IV Pole Height

Steps to set the maximum height the IV pole can reach.

Testing the IV Pole

Procedure for testing the functionality and movement of the IV pole.

Event Log

How to view and export the system's event log.

Wireless Foot Pedal Setup

Guides for pairing VERITAS Foot Pedal or Advanced Linear Pedal wirelessly.

VERITAS Remote Control Setup

Instructions for pairing the VERITAS Remote Control via wireless Bluetooth.

System Versions

Displays the software and firmware versions of the system.

System Self Test

Performs a test of all system components to verify proper operation.

Language Selection

Allows selection of the user interface language from a list of options.

Surgical Media Center (SMC) (Optional)

Configuration options for the optional SMC to record surgery video and data.

Set System Date and Time

Procedure to set the system's date, time, and display formats.

Set Units of Measure for Vacuum

Allows setting the units of measure for vacuum display (mmHg or kPa).

Service Interval

Provides information on preventative maintenance dates and system usage counts.

Import/Export Database

Functionality to import or export surgeon programs and database files.

Backup All

Saves a backup of the system database to a USB device.

Print to File

Exports selected surgeon programs as text files to a USB drive.

Restore Database

Restores a database from a saved file if the current database is corrupted.

Restore All

Restores a database saved via the Backup All option.

Delete a Backup Database

Procedure for deleting a database from a portable USB device.

8 — Symbol Definitions

Power and Control Symbols

Defines symbols related to power status, buttons, and system control.

Regulatory and Certification Symbols

Explains symbols indicating regulatory compliance and certification.

Safety and Handling Symbols

Defines symbols for safety precautions, reuse, and environmental protection.

Electrical and Connectivity Symbols

Symbols indicating electrical ratings, EMC compliance, and port types.

Operational and Feature Indicators

Icons representing foot pedal status, technology activation, and battery charge.

Action and Configuration Icons

Icons representing actions like clearing errors, logging events, and setting parameters.

Program Management Icons

Icons for managing surgeon and program settings like editing, deleting, and copying.

Timer and Status Icons

Icons indicating timer resets, connection status, and wireless pairing success.

9 — Care and Cleaning

Cleaning and Sterilization Procedures

General guidance on handling and disposing of reusable and single-use items.

Phaco Handpiece

Refer to specific directions for cleaning, handling, and sterilization of the phaco handpiece.

Irrigation/Aspiration Handpiece

Refer to specific directions for cleaning, handling, and sterilization of the I/A handpiece.

Diathermy Handpiece and Cable

Refer to specific directions for cleaning, handling, and sterilization of the diathermy handpiece.

Vitrectomy Cutter

Notes the vitrectomy cutter as a disposable, single-use instrument.

Touchscreen Monitor Cleaning

Recommended materials and solutions for cleaning the touchscreen monitor.

General Cleaning (Console, Foot Pedal, Remote Control)

Instructions for wiping down the system, remote, and foot pedal with disinfectant cleaner.

10 — Error Messages, Troubleshooting, and Diagnostics

Errors

Describes system errors, including tone generation, message display, and safe state behavior.

Most Common User-Correctable Problems

Lists common issues and their solutions to help resolve problems before contacting service.

Fuse Replacement Procedure

Step-by-step guide for replacing console fuses if the system does not power on.

Battery Replacement – VERITAS Foot Pedal and Advanced Linear Pedal

Instructions for replacing the battery in the foot pedals.

Battery Replacement – VERITAS Remote Control

Procedure for replacing the batteries in the VERITAS Remote Control.

Charging Options for Wireless Foot Pedals

Details on how to charge wireless foot pedals using the AC charger.

Troubleshooting (General)

Guides for resolving general system issues like power or remote control pairing.

Troubleshooting (Foot Pedal)

Addresses issues with foot pedal operation and connection.

Troubleshooting (IV Pole)

Troubleshooting steps for when the IV pole does not respond.

Troubleshooting (Priming)

Common errors encountered during the priming process and their solutions.

Troubleshooting (Irrigation)

Addresses irrigation flow issues, including no flow or insufficient flow.

Troubleshooting (Aspiration)

Covers aspiration issues like no aspiration or poor aspiration.

Troubleshooting (Phacoemulsification)

Solutions for no or intermittent phacoemulsification.

Troubleshooting (Diathermy)

Addresses issues related to no or poor diathermy performance.

Status, Warning, and Error Messages

Explains system alerts, warnings, and error messages with corrective actions.

11 — Warranty and Maintenance

Warranty Statement

Details the manufacturer's warranty coverage for the VERITAS Vision System.

Extended Warranty

Information on the availability of extended warranty contracts.

Maintenance

Describes user maintenance and JJSV recommended periodic maintenance.

12 — Specifications

Physical Specifications

Provides dimensions and weight for the system console and foot pedal.

Environmental Specifications

Details operating and storage conditions, including temperature and humidity.

Electrical Specifications

Lists voltage, frequency, power rating, and enclosure current leakage.

Electromagnetic Compatibility

Discusses EMC precautions and guidance for operating the system near other devices.

RF Wireless Technology

Details the RF wireless technology used for devices like foot pedals and remote control.

Bluetooth Characteristics

Provides RF receive and transmit section specifications for Bluetooth connectivity.

Phacoemulsification Specifications

Lists specifications for phaco power and pump settings.

Irrigation and Aspiration Specifications

Details vacuum level and pump flow rate specifications for I/A.

Vitrectomy Specifications

Provides specifications for vitrectomy pump, cut rate, and altitude de-rating.

Diathermy Specifications

Lists power adjustment, output current, and peak voltage for diathermy.

Diathermy Power Graphs

Graphical representation of diathermy output power versus settings.

Diathermy Power versus Load Impedance

Graphs showing diathermy output power at different load impedance settings.

Phaco Power Graphs

Illustrates phaco power output in watts versus GUI settings percentage.

Phaco Tip Velocity

Nominal longitudinal velocity for various handpieces with a specific phaco tip.

Bottle Height Pressure

Explains how the IV pole generates pressure and measurement points.

13 — Accessories and Parts Reordering

List of Accessories with Part Numbers

A comprehensive list of accessories and their corresponding part numbers for reordering.