Johnson & Johnson Surgical Vision Veritas User manual

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

Z370584 Rev. D
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Z370584 Rev. D
This manual contains information for the VERITAS
™
Vision System. The information
contained in this document is the confidential and proprietary property of Johnson &
Johnson Surgical Vision, Inc. No part of this publication may be reproduced or transmitted
in any form or by any means, electronic or mechanical, including photocopying, recording,
or any information storage and retrieval system, without permission in writing from Johnson
& Johnson Surgical Vision, Inc.
iPad is a trademark of Apple Inc., registered in the U.S. and other countries.
ALLEGRO, DUET, MAESTRO, and SOLO are trademarks of Micro-Surgical Technology, Inc.
BLUETOOTH is a trademark of Bluetooth SIG, Inc.
DURACELL and COPPERTOP are trademarks of Duracell U.S. Operations, Inc.
All third party trademarks are the property of their respective owners.
Please note that while every effort has been made to ensure the data provided in this
document are accurate, the information, figures, illustrations, tables, specifications, and
schematics contained herein are subject to change without notice.
Manufacturer:
Johnson & Johnson Surgical Vision, Inc.
1700 E. St. Andrew Place
Santa Ana, CA, USA 92705
1-877-266-4543
Authorized Representative in the European Community:
Johnson & Johnson Surgical Vision, Inc. Ireland
Block B
Liffey Valley Office Campus
Quarryvale, Co. Dublin, Ireland
For order placement of consumables, new accessory items and product returns, call
1-877-266-4543 (USA and Canada). Outside of the USA and Canada, contact your local
representative. All returns must be accompanied by a Returned Goods Authorization (RGA)
number.
For Technical Service and Support, call 1-800-511-0911 (USA and Canada). Outside of the
USA and Canada, contact your local Technical Support representative.
Caution: Federal law (U.S.A.) restricts this device to sale by or on order of a physician.
© Johnson & Johnson Surgical Vision, Inc. 2020

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Table of Contents
1 — Introduction
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Intended Use / Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Undesirable Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Intended Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Intended User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Clinical Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
VERITAS Vision System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
VERITAS Vision System Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
FUSION Fluidics System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
VERITAS Vision System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
WHITESTAR Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
2 — Warnings, Cautions, and Other Residual Risks
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Residual Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Regulatory Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Regulatory Compliance Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Federal Communications Commission (FCC) Compliance Statement . . . . . . . . . .2-10
Industry Canada (IC) Notice of Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
System Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
WEEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Toxic and Hazardous Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Restriction of Hazardous Substances in Electrical and Electronic Equipment
(EU RoHS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
RoHS information for China . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Registration, Evaluation, Authorization and Restriction of Chemicals (EU REACh) 2-12
Packaging Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Serious Incident Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Instructions for Minimizing the Environmental Impact During Normal Use . . 2-13

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3 — System Components
Receipt and Inspection Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
VERITAS Vision System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Tubing Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
VERITAS Advanced Fluidics Tubing Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
VERITAS Advanced Infusion Tubing Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
FUSION Dual Pump Tubing Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Removing the Handle from the Advanced Linear Pedal . . . . . . . . . . . . . . . . . . . . . . 3-11
Foot Pedal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
Foot Pedal Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
VERITAS Heel Insert (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Programmable IV Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
VERITAS Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
VERITAS Remote Control Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Surgical Media Center (SMC) (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
4 — Surgery Start Up
VERITAS Vision System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Front and Rear Panel Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
IV Pole Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Handpiece Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Phacoemulsification Handpiece Setup – VERITAS Swivel . . . . . . . . . . . . . . . . . . . . 4-5
Phacoemulsification Handpiece Setup – WHITESTAR and ELLIPS FX . . . . . . . . . . 4-7
Irrigation/Aspiration Handpiece Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Diathermy Handpiece Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Vitrectomy Cutter Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Install the Tubing Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Cup Fill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Prime/Tune . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Suggestions for Priming the Handpieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Verify Irrigation/Aspiration Balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Priming for Vitrectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Selecting and Changing Mode Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
System Check-out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
Phacoemulsification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
Irrigation and Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
Diathermy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21
Vitrectomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Pre-operative Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

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End Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Review Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
End Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
System Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
5 — Surgeon Settings
Select Surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Add a New Surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Delete Surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Edit a Surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Edit Surgeon Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Foot Pedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Single Linear Foot Pedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
VERITAS Foot Pedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-15
Advanced Control Pedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Advanced Linear Pedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31
Set Sound Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Default Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Surgeon – Assign Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
6 — Program Settings
Create a New Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Delete a Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Edit a Program Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Lock a Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Copy a Surgeon Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Assign Program Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Program Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Phaco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Irrigation and Aspiration (I/A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Vitrectomy (VIT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Diathermy (DIA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Advanced Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12
Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Phaco Power Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Continuous Phaco Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Pulse Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Short Pulse Phaco Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Long Pulse Phaco Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Low Power Pulse Phaco Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
High Power Pulse Phaco Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21

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Single Burst Phaco Power (Panel Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21
Multiple Burst Phaco Power (Panel Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21
Continuous Burst Phaco Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21
WHITESTAR Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
FUSION Fluidics Phaco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Occlusion Mode Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Occlusion Vacuum Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Occlusion Mode Power Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-31
Venting an Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
CASE Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
CASE One Touch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
Reflux. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
7 — System Configuration
Setting the Maximum IV Pole Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Testing the IV Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Wireless Foot Pedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
VERITAS Foot Pedal and Advanced Linear Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Advanced Control Pedal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7
VERITAS Remote Control Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
VERITAS Remote Control Pairing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Wireless VERITAS Remote Control Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
System Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
System Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-11
Language Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Surgical Media Center (SMC) (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Set System Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Set Units of Measure for Vacuum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
Service Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Import/Export Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17
Import . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-19
Backup All . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Print to File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Restore Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Restore All . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
Delete a Backup Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-25
8 — Symbol Definitions

Z370584 Rev. D
v
9 — Care and Cleaning
Cleaning and Sterilization Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Phaco Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Irrigation/Aspiration Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Diathermy Handpiece and Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Vitrectomy Cutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Touchscreen Monitor Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Materials and Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Cleaning Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
General Cleaning (Console, Foot Pedal, Remote Control) . . . . . . . . . . . . . . . . . 9-3
10 — Error Messages, Troubleshooting, and Diagnostics
Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Most Common User-Correctable Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Fuse Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Battery Replacement – VERITAS Foot Pedal and Advanced Linear Pedal . . . 10-3
Battery Replacement – VERITAS Remote Control . . . . . . . . . . . . . . . . . . . . . . 10-4
Charging Options for Wireless Foot Pedals . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
Irrigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Phacoemulsification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Diathermy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Vitrectomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
Status, Warning, and Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
11 — Warranty and Maintenance
Warranty Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-1
Extended Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
12 — Specifications
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
RF Wireless Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10

Z370584 Rev. D
vi
Bluetooth Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-17
Phacoemulsification Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-19
Irrigation and Aspiration Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-19
Vitrectomy Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-20
Diathermy Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-20
Diathermy Power Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-21
Diathermy Power versus Load Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-24
Phaco Power Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-25
Phaco Tip Velocity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26
Bottle Height Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26
13 — Accessories and Parts Reordering
List of Accessories with Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Index

Z370584 Rev. D
1-1
1 — Introduction
•“Introduction” on page 1-1
•“Document Conventions” on page 1-3
•“Intended Use / Indications” on page 1-4
•“Contraindications” on page 1-4
•“Undesirable Side Effects” on page 1-4
•“Intended Patient” on page 1-4
•“Intended User” on page 1-4
•“Clinical Benefits” on page 1-5
•“Performance Characteristics” on page 1-5
•“Device Description” on page 1-6
Introduction
The VERITAS™Vision System is a premium cataract system with the intended use of phaco
fragmentation and removal of the crystalline lens during cataract surgery. The VERITAS
Vision System features technological advancements in fluidics management and ergonomic
improvements for the console, foot pedal, handpiece, and remote control.

Introduction Z370584 Rev. D
1-2
Introduction
Figure 1-1 — VERITAS Vision System (front)
1. Programmable IV Pole 3. Front Panel Connections (see Figure 4-1)
2. Tubing Pack inserted 4. Foot Loop for system repositioning

Introduction
Z370584 Rev. D Document Conventions
1-3
The VERITAS Vision System consists of the following components:
1. Programmable IV Pole – supports hanging bottle or bag for fluid management
2. Tubing Pack – disposable to realize the fluid handling during irrigation / aspiration (see
separate Instructions for Use)
3. Wireless remote control – alternative to the touchscreen monitor (see Figure 3-1)
4. Front Panel allows for the following handpiece connections:
a. Phacoemulsification Handpieces (VERITAS Swivel Handpiece/WHITESTAR™
Handpiece/ELLIPS™FX Handpiece) – to be connected with the console. Ultrasound
assisted surgical instrument including connections for fluid management (see
separate Instructions for Use).
b. Irrigation / Aspiration Handpieces – to be connected with the console. Surgical
instrument without Ultrasound assistance (see separate Instructions for Use).
c. Diathermy Handpieces – to be connected with the console. Bi-polar surgical HF-
instrument (see separate Instructions for Use).
d. Vitrectomy cutter – to be connected with the console. Pneumatic cutter including
connections for fluid management (see separate Instructions for Use).
5. Foot pedal and foot pedal cable – variants:
a. VERITAS Foot Pedal
b. Single Linear Pedal (SLP)
c. Advanced Control Pedal (ACP)
d. Advanced Linear Pedal (ALP)
Document Conventions
This manual presents two types of precautionary statements: cautions and warnings. Both
types of precautionary statements must be observed to ensure safe and effective operation
of the VERITAS Vision System.
WARNING!
Identifies conditions or practices that could result in patient injury.
CAUTION!
Identifies conditions or practices that could result in damage to equipment or data
loss.

Intended Use / Indications Z370584 Rev. D
1-4
Introduction
NOTE: Provides background information to clarify a particular step or procedure.
Intended Use / Indications
The VERITAS Vision System is a modular ophthalmic microsurgical system that facilitates
anterior segment (cataract) surgery. The modular design allows the users to configure the
system to meet their surgical requirements.
Contraindications
Any pre-existing patient condition/s that the health care provider determines to be a
contraindication to cataract surgery.
Undesirable Side Effects
Complications that may be associated with the VERITAS Vision System include
•corneal burn
•infection/inflammation
•corneal edema
•broken capsule
Intended Patient
Adult patients with cataracts or adult patients undergoing anterior segment ophthalmic
surgery (e.g., removal of the crystalline lens).
NOTE: Pregnant or nursing women were not included in the clinical trial(s) conducted.
Intended User
The JJSV Phacoemulsification System is intended for use by an ophthalmologist and support
staff operating under the direction of the surgeon.
IMPORTANT:
Identifies instructions important to the proper operation of the device.

Introduction
Z370584 Rev. D Clinical Benefits
1-5
Clinical Benefits
Clinical benefits of the VERITAS Vision System include the following:
•Rapid visual rehabilitation
•Early resumption of daily activities
•Minimal ocular inflammation
•Minimal postoperative astigmatism
•Reduced potential for ocular complications
Performance Characteristics
•Phacoemulsification under irrigation / aspiration
•Independent irrigation / aspiration mode
•Diathermy – High Frequency surgical procedure for cutting soft tissue
•Vitrectomy – mechanical cutting of Vitreous tissue in the anterior eye chamber
•WHITESTAR Technology – finely modulated pulses of emulsification energy, interrupted
by extremely brief cooling periods
•WHITESTAR ICE Technology – This pulse shaping technology modifies the standard
“square” wave pulse by increasing the amplitude of the first millisecond of the on time
“kick”. This technology then sets the remaining part of the on time to the standard power
setting. This results in increased control and efficiency in phacoemulsification.
•Occlusion Mode Phaco – This mode regulates the vacuum rise time following an occlusion
of the phaco tip, without limiting the choice of aspiration rate. The Occlusion mode phaco
also regulates the ultrasound power modulation.
•FUSION™Mode – allows the user to access the settings and variables for both CASE and
Occlusion mode phaco
•
Chamber Stabilization Environment (CASE) – an intelligent vacuum monitoring system that
regulates the maximum allowable vacuum used following the occlusion of the phaco tip
•2.1 to 3.25 mm incision phaco (19GA, 20GA, 21GA) capabilities
•Peristaltic- and/or venturi-based aspiration
•Controlling surgical parameters by supported foot pedal and wireless remote-control unit

Device Description Z370584 Rev. D
1-6
Introduction
Device Description
VERITAS Vision System Console
Operating room teams contributed significantly to the successful design of the system
console. The solid wheel base and locking wheels make the console stable and smooth
rolling. An adjustable height Mayo tray accommodates the handpieces and tubing. The
VERITAS Remote Control uses standard commercially available AA batteries for easy
replacement. The foot pedal can be stored on a hanging hook when not in use.
VERITAS Vision System Display (Graphic User Interface–GUI)
The system graphic screen display is easy to read and easy to operate. You can see at a
glance the status of the system. The screen gives you visual indication of operating modes,
settings, and system status. Messages cue you through the procedure with illustrations and
prompts to indicate proper connections or system selections. Information is provided to help
resolve error messages.
Prime/Tune
Before the start of each surgical case, the system requires that you run prime, tune or prime/
tune. The prime mode incorporates the function of clearing the tubing of air, then fills the
tubing and completes the fluid aspiration check and the vacuum check. The tune mode
incorporates an ultrasonic power calibration check and safety check for the attached phaco
handpiece. The prime/tune mode allows the system to prime and tune the handpiece at the
same time.
Dual Pump
The system provides a fluid aspiration system that uses either a peristaltic (flow-based) pump
or a Venturi (vacuum-based) pump system. The surgeon can use both the peristaltic pump
and the Venturi pump in the Phaco, Irrigation/Aspiration (I/A), and Vitrectomy surgical
modes.
Continuous Irrigation
Continuous Irrigation opens the irrigation valve for a collection of balanced salt solution
during a case, independent of the foot pedal or prime cycle. Continuous irrigation can be
used to fill cups prior to prime/tune and is immediately available by way of the touchscreen
monitor. Tap the Cont. Irr. button to open the valve and start the flow of irrigation fluid. Tap
the button again to close the valve and stop the flow of irrigation fluid. Surgeon control of
continuous irrigation with the foot pedal is also available. The cup fill feature can be used in
place of continuous irrigation to fill a cup. The cup fill feature is only available on the Prime/
Tune screen. (See “Prime/Tune” on page 4-14 for detailed information.)
Continuous Irrigation Auto-Off (Cont. Irr. Auto-Off)
Continuous Irrigation Auto-Off (Cont. Irr. Auto-Off) is available in the Surgeon Settings.
When this feature is enabled, continuous irrigation will automatically turn on when the foot
pedal is pressed, and automatically turn off when the handpiece is removed from the anterior
chamber and the foot pedal is released. The time at which continuous irrigation

Introduction
Z370584 Rev. D Device Description
1-7
automatically turns off can be set per surgeon preference. Please note that when this feature
is enabled, a significantly large wound leakage or air bubbles in the tubing lines may affect
the continuous irrigation auto-off.
Advanced Infusion
Advanced Infusion is available when the VERITAS Advanced Infusion Pack is installed and
the feature is selected in the Program Settings. When this feature is enabled, pressurized air
(equivalent to 30 cm of bottle height) is added to the irrigation source. The pressurized air is
supplied by an additional tubing line that is connected to the side panel of the console during
pack setup.
NOTE: Using the Advanced Infusion feature in conjunction with vitrectomy at altitudes
above 5,000 feet may result in lower than expected irrigation pressure.
Programmable Operating Parameters
The system is programmable through the screens on the touchscreen monitor. You can
select your desired settings for each portion of the anterior surgical procedure. The
instrument program memory stores up to 100 surgeon names with a maximum of 20 different
setups, plus the two JJSV default settings programs—Advanced Fluidics Program and
Advanced Infusion Program. This allows different users to preset their preferences, or
individual users to select setups for different procedures, including a personalized initial
operating mode.
MMP – Multiple Mode Programming
Multiple submodes are available within the system operating modes. The multiple submodes
allows you to preset your settings for specific techniques such as phaco chop or viscoelastic
removal.
Programmable IV Pole
The system has a programmable IV pole. You can set the programmable IV pole height
parameters independently for each of the Phaco modes plus settings for I/A and vitrectomy.
During surgery, the programmable IV pole height changes to the preprogrammed height
when you switch modes.
The automated and programmable IV pole allows adjustment of the bottle height to provide
gravity infusion through each procedural phase. The up and down arrows on the touchscreen
or the wireless VERITAS Remote Control raises or lowers the irrigation source that contains
the bottled balanced salt solution, while maintaining the sterility within the operating field. A
separate up and down switch allows IV pole adjustment from the side of the system. The foot
pedal can also be programmed to move the IV pole.
NOTE: The IV pole movement is calibrated in centimeters. When the IV pole height is set to
inches, the height shown may not update immediately upon pressing the up arrow or
down arrow.

Device Description Z370584 Rev. D
1-8
Introduction
When using the system with the Advanced Infusion Program, the effective bottle height
includes an extra 30 cm to the programmed IV Pole height due to pressurizing the irrigation
source.
VERITAS Vision System Operating Modes
The design of the system provides all the operating modes and surgical capabilities that the
anterior segment surgeon or the cataract surgeon requires. These capabilities include:
Phacoemulsification (Phaco)
You use the phacoemulsification mode to break up (emulsify) the nucleus of the lens. You
then aspirate the nucleus of the lens from the eye through a small incision. The continuous
autotuning circuitry maximizes the emulsification efficiency for each lens density, even
varying densities within the same lens. The system displays phaco time in minutes and
seconds. The convenient selection of linear or panel preset phaco power, in a variety of
power delivery options (continuous, pulsed, burst), provides increased precision, and
control.
The WHITESTAR Technology allows safe removal of all lens types through small incisions
with single-mode, single-instrument convenience.
The WHITESTAR Technology is a patented software program proven to change the
characteristics of phacoemulsification using little or no ultrasound. The WHITESTAR
Technology changes the thermal properties and improves control of the lens without
reducing the cutting power or changing technique or efficiency.
Irrigation/Aspiration (I/A)
The Irrigation/Aspiration mode allows for controlled aspiration of cortical material from the
eye, while maintaining intraocular stability, by replacing the aspirated material with a
balanced salt solution. This mode gives you flexible control of each case with the
independently adjustable vacuum level settings and flow rate settings. A peristaltic pump
provides a predictable and stable aspiration rate. “Aspiration Rate” and “Vacuum” settings
allows for complete control. Irrigation is gravity-fed.
NOTE: The vacuum units can be set to either mmHg or kPa. To set the vacuum units go to
Configuration, Set Vacuum Units.
You can regulate the gravity-fed irrigation by adjusting the height of the IV pole.
Vitrectomy (VIT)
You use the Vitrectomy mode to remove vitreous from the eye during surgery. The system
uses air pressure to drive the vitreous cutter. The wide range of user-controlled,
programmable cut rates supports both anterior segment and posterior segment surgeries.
Diathermy (DIA)
Most surgeons use the Diathermy mode to coagulate blood vessels during the procedure and
by some surgeons to “coag” the conjunctiva at the end of the procedure. An isolated output
frequency allows noncontact tissue coagulation, eliminating adhesion, and traction. Also,

Introduction
Z370584 Rev. D Device Description
1-9
the depth of penetration of the energy field is less than that of lower frequency units, which
minimizes tissue shrinkage or charring. The gentleness of the Diathermy mode allows the
surgeon to stop “bleeders” within the incision with only minimal scleral shrinkage.
CASE One Touch
The One Touch button simplifies the programming of the CASE function and allows you to
easily define the basic CASE settings once. You can adjust the CASE function with the CASE
One Touch settings on the surgical screens. When you use these controls, the CASE
functionality changes to provide enhanced control or improved efficiency to suit any
particular combination of cataract density, surgical technique or personal preferences.
See “CASE One Touch” on page 6-35.
FUSION Fluidics System
The system has both a flow-based peristaltic pump system and a vacuum-based Venturi
pump system. The patented microprocessor-based system continuously monitors and
controls intraocular conditions of the flow and vacuum in the eye.
Chamber Stabilization Environment (CASE)
CASE is an intelligent vacuum monitoring system that regulates the maximum allowable
vacuum used following the occlusion of the phaco tip. When the phaco tip becomes
occluded, the vacuum rises. Clearing of the occlusion while the vacuum is at a high-level can
lead to a post occlusion surge. When CASE is on, the system monitors the actual vacuum
levels. When the vacuum exceeds a specific threshold for a specified duration, the system
automatically adjusts the maximum allowable vacuum setting to a lower predefined CASE
maximum vacuum level. When the occlusion clears, the system automatically restores the
settings to the original programmed maximum vacuum setting. This function makes it
possible to have a different maximum vacuum setting when the tip occludes than when the
tip is unoccluded.
VERITAS Vision System Components
VERITAS Remote Control
The surgery can be controlled from the wireless VERITAS Remote Control keypad. You can
access all surgical modes and adjust all surgical settings with the use of the wireless
VERITAS Remote Control.
Foot Pedal
The foot pedal controls the various operating modes of the instrument. You can program the
foot pedal settings through the user interface. You can use either the VERITAS Foot Pedal,
Single Linear Foot Pedal, Advanced Control Pedal, or the Advanced Linear Pedal with the
system.
The foot pedal design offers control through the use of increased linearity with the foot pedal
movement. The design provides uniform pressure throughout the foot pedal movement,
easing foot and leg fatigue. You can select the degrees of movement for each foot pedal
position. You can save the settings for each surgeon/mode, pitch for the VERITAS Foot

Device Description Z370584 Rev. D
1-10
Introduction
Pedal, Single Linear Foot Pedal, and the Advanced Linear Pedal, and pitch and yaw for the
Advanced Control Pedal giving the pedal dual linear functionality. Programmable switches
can activate reflux, giving an immediate response.
Accessories
VERITAS Swivel Handpiece
The VERITAS Swivel phaco handpiece (Figure 1-2) is the next generation handpiece from
JJSV. Its front metal housing is able to rotate independently of its rear housing that is
connected to the tubing and cable, thus reducing surgeon hand fatigue. The VERITAS Swivel
phaco handpiece provides both longitudinal and transversal movement. You can use the
handpiece with a straight tip or a curved tip. The handpiece is lightweight, slim, and easy to
clean and sterilize with conventional steam autoclave methods.
Figure 1-2 — VERITAS Swivel Handpiece
WHITESTAR Handpiece
The design of the WHITESTAR phaco handpiece has a straight-through aspiration channel
for more efficient removal of nuclear fragments, to minimize clogging and to facilitate
cleaning. The handpiece is lightweight, slim, and well-balanced, making it comfortable to
use and easy to control.
ELLIPS FX Handpiece
The ELLIPS FX phaco handpiece is available for use with the VERITAS Vision System. The
ELLIPS FX handpiece provides both longitudinal and transversal movement. You can use the
handpiece with a straight tip or a curved tip.
WHITESTAR Technology
The VERITAS Vision System incorporates WHITESTAR Technology to deliver finely
modulated pulses of energy, interrupted by extremely brief cooling periods. This allows the
system to achieve full ultrasound cutting efficiency and magnetic followability, while
introducing less energy into the eye. Minimized ultrasonic time reduces the risk of thermal
damage.